This study was an exploratory pilot study to investigate the effects of recombinant human EPO ( rhEPO ) on motor and non-motor symptoms ( NMS ) in PD patients .


A total of 26 PD patients at the Hanyang University Hospital were enrolled in the study .


The participants were randomly assigned to rhEPO and placebo groups .


The rhEPO group was infused intravenously ( 40,000 IU each ) twice a week for 5 weeks .


Clinical improvement was estimated using the Unified Parkinson 's Disease Rating Scale-III ( UPDRS-III ) , the NMS Scale ( NMSS ) and the 39-Item Parkinson 's Disease Questionnaire ( PDQ-39 ) .


[ ( 18 ) F ] N - ( 3-fluoropropyl ) -2 - carbon ethoxy-3 - ( 4-iodophenyl ) nortropane ( FP-CIT ) photon emission tomography ( PET ) scanning was performed on each participant at baseline and again after 12 months .


The rhEPO administration significantly improved the NMSS and PDQ-39 scores at 12 months .


The UPDRS-III , which reflects motor function , did not change significantly after the rhEPO treatment .


With the NMSS , the domains of cardiovascular autonomic function , sleep/fatigue , mood/cognition and attention/memory showed significant changes .


None of the participants experienced any serious adverse effects .


We found that rhEPO had beneficial effects on NMS but not on motor function .


Dopaminergic refractory NMS , such as cardiovascular autonomic dysfunction and cognition , showed improvement after the administration of rhEPO .


Our results suggest that rhEPO might be a good candidate for the treatment of NMS in PD patients .


In the present study , the potential benefits of oral carnitine in preventing antituberculosis drug-induced hepatotoxicity ( ATDH ) were evaluated .


Fifty-four patients in the carnitine and 62 patients in the placebo group completed the study .


The carnitine group received 1000mg oral carnitine solution twice daily for 4 weeks .


The placebo group received 10mL of oral placebo solution twice daily for 4 weeks .


ATDH was defined as an increase in the serum level of aspartate aminotransferase or alanine aminotransferase greater than three or five times of the upper limit of normal with or without clinical symptoms of hepatotoxicity , respectively .


During the study period , 29 ( 25 % ) patients experienced ATDH .


Among these patients , nine ( 16.7 % ) and 20 ( 32.3 % ) were in the carnitine and placebo groups , respectively ( P = 0.049 ) .


Based on multivariate logistic regression model , age over 35 years old ( odds ratio [ OR ] = 7.01 , P = 0.002 ) , human immunodeficiency virus infection ( OR = 40.4 , P < 0.001 ) , diabetes mellitus ( OR = 37.6 , P = 0.001 ) , and placebo treatment ( OR = 0.1 , P = 0.01 ) were identified as predisposing factors for ATDH .


Results of our preliminary clinical trial suggested that cotreatment with 2000mg oral L-carnitine solution daily for 4 weeks significantly decreased the rate of ATDH .


Girdles and abdominal binders may reduce pain and stabilize the abdominal wall after laparotomy , but a risk for increased intra-abdominal pressure and decreased lung function is also hypothesized .


The aim of this study was to investigate the effect of an abdominal girdle after midline laparotomy in a randomized controlled trial .


Twenty-three patients undergoing laparotomy were randomized to wear an elastic girdle postoperatively and 25 were randomized to no girdle .


Pulmonary function was evaluated with ; forced vital capacity ( FVC ) , forced expiratory volume during one second ( FEV1 ) , peak expiratory flow ( PEF ) , and cough PEF .


Pain was recorded using a visual analog scale ( VAS ) .


All patients completed the ventral hernia pain questionnaire ( VHPQ ) before surgery and at the end of the study .


Intra-abdominal pressure was measured via an indwelling urinary catheter .


Wound healing was assessed from photographs .


FVC , FEV1 , PEF , and cough PEF were reduced by about 30 % after surgery , but there were no differences between patients with or without a girdle ( ANOVA ) .


Intra-abdominal pressure and wound healing were the same in both groups .


Pain was significantly lower on day 5 in the girdle group ( p = 0.004 ) .


An individually fitted elastic girdle used after midline laparotomy was found to be safe , as this did not affect lung function , coughing , intra-abdominal pressure , or wound healing .


The immediate decline in lung function after surgery is restrictive and due to anesthesia and the surgical procedure .


Pain was significantly decreased in the girdle group .


The study is registered at ClinicalTrials.gov , number NCT01517217 .


Sexual dimorphism in plasma triglyceride ( TG ) metabolism is well established but it is unclear to what extent it is driven by differences in the sex hormone milieu .


RESULTS from previous studies evaluating the effects of sex steroids on plasma TG homeostasis are inconclusive because they relied on orally administered synthetic hormone preparations or evaluated only plasma lipid concentrations but not kinetics .


The purpose of this study was to evaluate the effects of systemically delivered 17-estradiol , progesterone , and T on very low density lipoprotein-triglyceride ( VLDL-TG ) concentration and kinetics in postmenopausal women .


VLDL-TG concentration and kinetics were evaluated by using stable isotope-labeled tracer techniques in four groups of postmenopausal women ( n = 27 total ) who were studied before and after treatment with either 17-estradiol ( 0.1 mg/d via continuous delivery skin patch ) , progesterone ( 100 mg/d via vaginal insert ) and T ( 12.5 mg/d via skin gel ) , or no intervention ( control group ) .


VLDL-TG concentration and kinetics were unchanged in the control group and not altered by T and progesterone administration .


Estradiol treatment , in contrast , reduced VLDL-TG concentration by approximately 30 % due to accelerated VLDL-TG plasma clearance ( 25.1 2.5 vs. 17.4 2.7 mL/min ; P < .01 ) .


Estradiol , but not progesterone or T , is a major regulator of VLDL-TG metabolism .


Ombrabulin ( AVE8062 ) disrupts the vasculature of established tumours and has shown preclinical synergistic anti-tumour activity when combined with cisplatin .


In this phase 3 trial , we aimed to assess the efficacy and safety of ombrabulin plus cisplatin compared with placebo plus cisplatin in patients with advanced soft-tissue sarcomas .


We did this multinational , randomised , double-blind , placebo-controlled phase 3 study at 44 centres in ten countries .


Patients aged 18 years and older with metastatic soft-tissue sarcomas , an Eastern Cooperative Oncology Group performance status of 0-2 , and who had previously received treatment with anthracycline and ifosfamide were randomly assigned ( 1:1 ) to intravenous infusion of ombrabulin 25 mg/m ( 2 ) plus cisplatin 75 mg/m ( 2 ) or intravenous infusion of placebo plus cisplatin 75 mg/m ( 2 ) every 3 weeks .


Patients were allocated to treatment using a permuted blocks randomisation scheme ( block size of four ) via an interactive voice-response system , and stratified by histological subtype .


Patients , medical staff , study investigators , and individuals who handled and analysed the data were masked to treatment assignment .


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


Safety analyses were done on all randomised patients who received at least one dose of study drug .


This trial is now closed , and is registered with ClinicalTrials.gov , number NCT00699517 .


Between June 13 , 2008 , and April 26 , 2012 , we randomly assigned 355 patients to ombrabulin plus cisplatin ( n = 176 ) or placebo plus cisplatin ( n = 179 ) .


Median duration of follow-up was 279 ( IQR 209-332 ) in the placebo group and 305 months ( 207-376 ) in the ombrabulin group .


Progression-free survival was slightly , but significantly , improved in the ombrabulin group compared with the placebo group ( median 154 months [ 95 % CI 145-269 ] vs 141 [ 138-158 ] months ; hazard ratio 076 [ 95 % CI 059-098 ] ; p = 00302 ) .


Grade 3 or 4 adverse events occurred more frequently in individuals in the ombrabulin group than in those in the placebo group and included neutropenia ( 34 [ 19 % ] in the ombrabulin group vs 14 [ 8 % ] in the placebo group ) and thrombocytopenia ( 15 [ 8 % ] vs six [ 3 % ] for placebo ) .


Adverse events leading to death occurred in 18 patients in the ombrabulin group and 10 patients in the placebo group .


The combination of ombrabulin and cisplatin significantly improved progression-free survival ; however , it did not show a sufficient clinical benefit in patients with advanced soft-tissue sarcomas to support its use as a therapeutic option .


Predictive biomarkers are needed for the rational clinical development of tumour vascular-disrupting drugs for soft-tissue sarcomas .


Sanofi .


To compare the curative effects of heat-sensitive moxibustion with conventional drugs on chronic persistent asthma and seek a valuable therapy to replace Western Medicine .


The participants in this multi-center , randomized , and controlled study were randomly divided into two groups : group A ( n = 144 ) , treated with heat-sensitive moxibustion ( 50 sessions ) and group B ( n = 144 ) , treated with Seretide ( salmeterol 50 plg/fluticasone 250 pg , twice a day ) .


The scores of asthma control test ( ACT ) , forced expiratory volume in 1 second ( FEV1 ) , peak expiratory flow ( PEF ) , and attack frequency were measured after 15 , 30 , 60 , and 90 days of treatment .


Patients followed up 3 and 6 months after treatment .


There was a significant difference ( P = 0.0002 ) in the ACT score and lung function between the two groups after 3 months of treatment and ( P = 0.000 03 ) during the follow-up visits .


In addition , heat-sensitive moxibustion reduced attack frequency in the period from inclusion to the 6-month follow-up visit .


This study shows that heat-sensitive moxibustion may have a comparable curative effect to Seretide ( salmetero/fluticasone ) on asthma .


To determine the efficacy of a custom-made wheelchair simulation in training children to use a powered wheelchair ( PWC ) .


Randomized controlled trial employing the 4C/ID-model of learning .


Twenty-eight typically developing children ( 13M , 15F ; mean age 6 years , SD 6 months ) were assessed on their operation of a PWC using a functional evaluation rating scale .


Participants were randomly assigned to intervention ( 8 30-minute training sessions using a joystick operated wheelchair simulation ) or control conditions ( no task ) , and were reassessed on their PWC use after the intervention phase .


Additional data from the simulation on completion times , errors , and total scores were recorded for the intervention group .


Analysis of variance showed a main effect of time , with planned comparisons revealing a statistically significant change in PWC use for the intervention ( p = .022 ) but not the control condition .


Although the intervention group showed greater improvement than the controls , this did not reach statistical significance .


Multiple regression analyses showed that gender was predictive of pretest ( p = .005 ) functional ability .


A simulated wheelchair task appears to be effective in helping children learn to operate a PWC .


Greater attention should be given to female learners who underperformed when compared with their male counterparts .


This low-cost intervention could be easily used at home to reduce PWC training times in children with motor disorders .


Aim of the study was to compare the chosen position of polyaxial locking screws with the position of monoaxial screws in the humeral head of proximal humeral fractures treated by locked plating .


In a prospective randomized observational study , 124 consecutive patients ( mean age 70.914.8 years ) sustaining a displaced proximal humeral fracture were treated with either monoaxial or polyaxial screw-inserted locking plate fixation .


The chosen positions of locking screws were identified from standardized postoperative radiographs in anteroposterior and outlet-view , with regard to a regional mapping of the humeral head .


In monoaxial locking technique , a mean of 6 screws purchased the humeral head ( 95 % CI 5.1-6 .2 ) , and in polyaxial locking technique , a mean of 4 screws ( 95 % CI 3.3-4 .5 ) , respectively .


Screws were placed in the regions superolateral : monoaxial 24.8 % , polyaxial 20.7 % ( p = 0.49 ) ; superomedial : monoaxial 21.9 % , polyaxial 20.0 % ( p = 0.433 ) ; inferolateral : monoaxial 32.5 % , polyaxial 35.0 % ( p = 0.354 ) ; inferomedial : monoaxial 20.8 % , polyaxial 24.2 % ( p = 0.07 ) , superoposterior : monoaxial 45.5 % , polyaxial 30.8 % ( p = 0.57 ) ; superoanterior : monoaxial 4.4 % , polyaxial 8.3 % ( p = 0.33 ) ; inferoposterior : monoaxial 22.5 % , polyaxial 29.8 % ( p = 0.49 ) and inferoanterior : monoaxial 27.5 % , polyaxial : 31.2 % ( p = 0.09 ) .


The chosen screws ' position in monoaxial and polyaxial locking plate fixation of displaced proximal humeral fractures do not differ significantly .


However , loss of fixation is observed more frequently if the fixation did not include at least one screw within the superoposterior region of the humeral head , suggesting that a screw purchasing the superoposterior region is beneficial in locked plating of proximal humeral fractures .


Treatment Study , Level II .


To evaluate the efficacy of a marketed oscillating-rotating ( O-R ) power toothbrush ( Oral-B Triumph with SmartGuide and FlossAction brush head , D34/EB25 ) to a new sonic toothbrush ( Sonicare FlexCare Platinum ) in the reduction of gingivitis and plaque over a 12-week test period .


This was a single center , randomized , open label , examiner-blind , two-treatment , parallel group study .


Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group .


Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks .


Gingivitis and plaque were evaluated at Baseline , Week 6 , and Week 12 .


Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) , and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Data were analyzed using an Analysis of Covariance ( ANCOVA ) with Baseline as the covariate .


In total , 130 subjects ( 65 per group ) were randomized to treatment and 127 subjects completed the study .


Both brushes produced statistically significant ( p < 0.001 ) reductions in gingivitis and plaque measures relative to Baseline .


At Week 12 , the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures ( p = 0.007 ) .


Additionally , the O-R brush presented significantly fewer bleeding sites ( p < 0.007 ) and significantly greater reductions in whole mouth plaque measures ( p < or = 0.035 ) at Weeks 6 and 12 versus the sonic brush .


The benefit for the O-R brush versus the sonic brush at Week 12 was 11.7 % for gingivitis , 19.8 % for number of bleeding sites , and 12.2 % for whole mouth plaque .


There were no adverse events reported or observed for either brush .


The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12 , as well as significantly greater gingivitis reductions over the long-term ( 12 weeks ) , compared to the new sonic toothbrush .


The echocardiographic substudy of the OASIS-6 trial evaluated the prognostic implications of left ventricle ( LV ) systolic and diastolic dysfunction early postacute ST-segment elevation myocardial infarction ( STEMI ) in patients treated with fondaparinux versus usual care .


Comprehensive echocardiograms were performed a median of 6 days after the index STEMI in 528 patients , 258 randomized to fondaparinux and 270 to usual care ( unfractionated heparin or placebo ) , to assess LV systolic and diastolic function , LV mass , and LV end-systolic and end-diastolic volumes .


A total of 245 ( 46.4 % ) patients were followed up for 3 months and 283 ( 53.6 % ) for 6 months .


Major cardiac events ( MACE ) were defined as the composite of death , reinfarction , heart failure , or cardiogenic shock and resuscitated cardiac arrest .


Patients with LV ejection fraction ( LVEF ) 45 % and restrictive diastolic function ( RDF ) were at greatly increased risk of MACE ( hazard ratio [ HR ] = 8.85 , 95 % CI , 4.2118.60 ) compared to patients with LVEF 45 % and without RDF .


RDF remained a strong predictor for MACE in patients with LVEF 45 % ( HR = 4.38 , 95 % CI , 1.5212.60 ) and in multivariate models adjusted for LVEF , LV end-systolic volume , and clinical variables .


In this large international trial , LV systolic and diastolic function , as determined by echocardiography early following STEMI , are incremental predictors of MACE .


In addition , RDF is a strong independent predictor of MACE after STEMI across a broad range of LVEF .


The self-reported health and functional status of persons with back pain in the United States have declined in recent years , despite greatly increased medical expenditures due to this problem .


Although patient psychosocial factors such as pain-related beliefs , thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain , few patients receive treatments that address these factors .


Cognitive-behavioral therapy ( CBT ) , which addresses psychosocial factors , has been found to be effective for back pain , but access to qualified therapists is limited .


Another treatment option with potential for addressing psychosocial issues , mindfulness-based stress reduction ( MBSR ) , is increasingly available .


MBSR has been found to be helpful for various mental and physical conditions , but it has not been well-studied for application with chronic back pain patients .


In this trial , we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain , compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes .


In this trial , we will randomize 397 adults with nonspecific chronic back pain to CBT , MBSR or usual care arms ( 99 per group ) .


Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice .


The MBSR protocol also includes an optional 6-hour retreat .


Interviewers masked to treatment assignments will assess outcomes 5 , 10 , 26 and 52weeks postrandomization .


The primary outcomes will be pain-related functional limitations ( based on the Roland Disability Questionnaire ) and symptom bothersomeness ( rated on a 0 to 10 numerical rating scale ) at 26weeks .


If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain , it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain .


Clinicaltrials.gov Identifier : NCT01467843 .


Endoplasmic reticulum stress and unfolded protein response have been recently associated with the development of inflammatory bowel diseases in adults .


We aimed at assessing the involvement of these pathways also in paediatric inflammatory bowel disease by analysing the expression of the main genes involved in endoplasmic reticulum stress and correlating them with the degree of intestinal inflammation .


Real-time PCR and Western blot analysis of the expression of the endoplasmic reticulum stress marker HSPA5 and of selected genes representing the three pathways of unfolded protein response ( IRE-XBP1 , PERK-ATF4 , ATF6p90-p50 ) in inflamed and uninflamed biopsies from 28 inflammatory bowel disease paediatric patients and 10 controls .


HSPA5 , PDIA4 , as well as unspliced and spliced XBP1 mRNAs were significantly increased in patients ' inflamed colonic mucosa compared to uninflamed mucosa and controls .


HSPA5 , PDIA4 , ATF6 , and phospho-IRE proteins were also upregulated , indicating the activation of the IRE-XBP1 and ATF6p90-p50 branches of unfolded protein response .


A positive significant correlation between interleukin-8 levels , as a marker of inflammation , and upregulated genes was found in the inflamed colonic mucosa .


A deregulation of the genes involved in the endoplasmic reticulum stress and unfolded protein response pathways may be a key component of the inflammatory response in paediatric patients with inflammatory bowel disease .


The aims of the present study were to define the prevalence of untreated atrial fibrillation ( AF ) in a systematic screening program using intermittent ECG recordings among 75 - to 76-year-old individuals and to study the feasibility of initiating protective oral anticoagulant ( OAC ) treatment .


Half of the 75 - to 76-year-old population in 2 Swedish regions were invited to a screening program for AF .


Participants without a previous diagnosis of AF underwent intermittent ECG recordings over 2 weeks .


If AF was detected , participants were offered OAC .


During the 28-month inclusion period , 13331 inhabitants were invited .


Of these , 7173 ( 53.8 % ) participated .


Of the participants , 218 ( 3.0 % ; 95 % confidence interval [ CI ] , 2.7-3 .5 ) were found to have previously unknown AF , and of these , AF was found in 37 ( 0.5 % of the screened population ) on their first ECG .


The use of intermittent ECGs increased new AF detection 4-fold .


A previous diagnosis of AF was known in 9.3 % ( n = 666 ; 95 % CI , 8.6-10 .0 ) .


Total AF prevalence in the screened population was 12.3 % .


Of participants with known AF , 149 ( 2.1 % ; 95 % CI , 1.8-2 .4 ) had no OAC treatment .


In total , 5.1 % ( 95 % CI , 4.6-5 .7 ) of the screened population had untreated AF ; screening resulted in initiation of OAC treatment in 3.7 % ( 95 % CI , 3.3-4 .2 ) of the screened population .


More than 90 % of the participants with previously undiagnosed AF accepted initiation of OAC treatment .


Mass screening for AF in a 75 - to 76-year-old population identifies a significant proportion of participants with untreated AF .


Initiation of stroke prophylactic treatment was highly successful in individuals with newly diagnosed AF .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01593553 .


CEREBEL compared the incidence of CNS metastases as first site of relapse in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer receiving lapatinib-capecitabine or trastuzumab-capecitabine .


Patients without baseline CNS metastases were randomly assigned ( 1:1 ) to receive lapatinib-capecitabine ( lapatinib 1,250 mg per day ; capecitabine 2,000 mg/m ( 2 ) per day on days 1 to 14 every 21 days ) or trastuzumab-capecitabine ( trastuzumab loading dose of 8 mg/kg followed by an infusion of 6 mg/kg every 3 weeks ; capecitabine 2,500 mg/m ( 2 ) per day on days 1 to 14 every 21 days ) .


The primary end point was incidence of CNS metastases as first site of relapse .


Secondary end points included progression-free survival ( PFS ) and overall survival ( OS ) .


The study was terminated early with 540 enrolled patients ( 271 received lapatinib-capecitabine , and 269 received trastuzumab-capecitabine ) .


Incidence of CNS metastases as first site of relapse was 3 % ( eight of 251 patients ) for lapatinib-capecitabine and 5 % ( 12 of 250 patients ) for trastuzumab-capecitabine ( treatment differences , -1.6 % ; 95 % CI , -2 % to 5 % ; P = .360 ) .


PFS and OS were longer with trastuzumab-capecitabine versus lapatinib-capecitabine ( hazard ratio [ HR ] for PFS , 1.30 ; 95 % CI , 1.04 to 1.64 ; HR for OS , 1.34 ; 95 % CI , 0.95 to 1.64 ) .


Serious adverse events were reported in 13 % ( 34 of 269 patients ) and 17 % ( 45 of 267 patients ) of patients in the lapatinib-capecitabine and trastuzumab-capecitabine arms , respectively .


CEREBEL is inconclusive for the primary end point , and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases .


A better outcome was observed with trastuzumab-capecitabine in the overall population .


However , lapatinib-capecitabine efficacy may have been affected by previous exposure to a trastuzumab regimen and/or when treatment was given as first - or second-line therapy in the metastatic setting .


Factors underlying differential responsiveness to opioid analgesic medications used in chronic pain management are poorly understood .


We tested whether individual differences in endogenous opioid inhibition of chronic low-back pain were associated with the magnitude of acute reductions in back pain ratings after morphine administration .


In randomized counterbalanced order over three sessions , 50 chronic low-back pain patients received intravenous naloxone ( 8 mg ) , morphine ( 0.08 mg/kg ) , or placebo .


Back pain intensity was rated predrug and again after peak drug activity was achieved using the McGill Pain Questionnaire-Short Form ( Sensory and Affective subscales , VAS Intensity measure ) .


Opioid blockade effect measures to index degree of endogenous opioid inhibition of back pain intensity were derived as the difference between predrug to postdrug changes in pain intensity across placebo and naloxone conditions , with similar morphine responsiveness measures derived across placebo and morphine conditions .


Morphine significantly reduced back pain compared with placebo ( McGill Pain Questionnaire-Short Form Sensory , VAS ; P < 0.01 ) .


There were no overall effects of opioid blockade on back pain intensity .


However , individual differences in opioid blockade effects were significantly associated with the degree of acute morphine-related reductions in back pain on all measures , even after controlling for effects of age , sex , and chronic pain duration ( P < 0.03 ) .


Individuals exhibiting greater endogenous opioid inhibition of chronic back pain intensity reported less acute relief of back pain with morphine .


Morphine appears to provide better acute relief of chronic back pain in individuals with lower natural opioidergic inhibition of chronic pain intensity .


Possible implications for personalized medicine are discussed .


The purpose of this study was to examine a dynamic assessment with graduated prompts to assess morphological awareness and determine whether such a task was related to third-grade literacy success .


A dynamic assessment of morphological awareness was adapted and administered to 54 third-grade students in addition to a norm-referenced language and literacy battery .


A dynamic assessment of morphological awareness measured a range of performance including that of emerging morphological awareness abilities and provided rich linguistic insights for how best to scaffold and prompt for such a skill .


In addition , the dynamic morphological awareness measure was found to be significantly related to , and to contribute unique variance to , reading comprehension abilities .


These results suggest that morphological awareness is an important factor to consider when addressing students ' literacy performance in early elementary school and that dynamic assessment appears to be a clinically valuable tool when examining early morphological awareness abilities .


Esophagogastrostomy for oesophageal cancer is the standard surgical treatment .


However , traditional techniques have been associated with high frequency of anastomotic complications .


The purpose of this study is to clarify the superiority of the oesophageal flap valvuloplasty and wrapping suturing technique in preventing postoperative complications after oesophagectomy for oesophageal cancer .


A prospective , randomised study was performed on 394 patients treated for esophageal cancer between January 2006 and December 2010 .


The trial registry number is ChiCTR-TRC-13003817 in the Chinese Clinical Trial Registry .


Anastomotic leaks occurred in four patients in group A ( 2.1 % ) and in twelve patients in group B ( 6.2 % ) with statistically significant ( P = 0.038 ) .


During the evaluation of benign stricture seven patients were excluded for hospital mortality .


Thirty three patients in group A ( 6.9 % ) and 25 patients in group B ( 13.2 % ) occurred anastomotic stricture respectively ( P = 0.044 ) .


Furthermore , reflux oesophagitis and Barrett 's epithelium were found in 105 patients ( 55.3 % ) of group B , and 54 ( 28.7 % ) patients in group A ( P < 0.001 ) .


The oesophageal flap valvuloplasty and wrapping suturing technique decreased anastomotic leakage incidence and stricture rate thereby decreasing the morbidity and mortality .


This procedure also prevented the occurrence of gastroesophageal reflux after esophagectomy .


Ultrasound-guided long-axis in-plane sciatic perineural catheter insertion has been described but not validated .


For the popliteal-sciatic nerve , we hypothesized that a long-axis in-plane technique , placing the catheter parallel and posterior to the nerve , results in faster onset of sensory anesthesia compared to a short-axis in-plane technique .


Preoperatively , patients receiving a popliteal-sciatic perineural catheter were randomly assigned to either the long-axis or short-axis technique .


Mepivacaine 2 % was administered via the catheter following insertion .


The primary outcome was time to achieve complete sensory anesthesia .


Secondary outcomes included procedural time , onset time of motor block , and pain on postoperative day 1 .


Fifty patients were enrolled .


In the long-axis group ( n = 25 ) , all patients except 1 ( 4 % ) had successful catheter placement per protocol .


Two patients ( 8 % ) in the long-axis group and 1 patient ( 4 % ) in the short-axis group ( n = 25 ) did not achieve sensory anesthesia by 30 min and were withdrawn .


Seventeen of 24 ( 71 % ) and 17 of 22 ( 77 % ) patients in the short-axis and long-axis groups , respectively , achieved the primary outcome of complete sensory anesthesia ( p = 0.589 ) .


The short-axis group ( n = 17 ) required a median ( 10th-90th ) of 18.0 ( 8.4-30 .0 ) min compared to 18.0 ( 11.4-27 .6 ) min for the long-axis group ( n = 17 , p = 0.208 ) to achieve complete sensory anesthesia .


Procedural time was 6.5 ( 4.0-12 .0 ) min for the short-axis and 9.5 ( 7.0-12 .7 ) min for the long-axis ( p < 0.001 ) group .


There were no statistically significant differences in other secondary outcomes .


Long-axis in-plane popliteal-sciatic perineural catheter insertion requires more time to perform compared to a short-axis in-plane technique without demonstrating any advantages .


Although the analgesic effect of periarticular injection after total knee arthroplasty ( TKA ) has been well documented , the gold standard for drug combination has not yet been established .


In this study , the analgesic effects of six different drug combinations were compared .


A total of 256 patients undergoing TKA for primary osteoarthritis were randomized into one of six groups : a control group ( saline solution , epinephrine , and cefazolin , n = 42 ) , Group 1 ( ropivacaine , n = 43 ) , Group 2 ( ropivacaine + morphine , n = 43 ) , Group 3 ( ropivacaine + ketorolac , n = 42 ) , Group 4 ( ropivacaine + morphine + ketorolac , n = 43 ) , and Group 5 ( ropivacaine + morphine + ketorolac + methylprednisolone , n = 43 ) .


Pain level assessed by visual analogue scale ( VAS ) and opioid consumption were primary outcomes .


The incidence of complications , range of motion ( ROM ) , C-reactive protein ( CRP ) value , and the amount of post-operative blood drainage were also compared .


Patients in Groups 4 and 5 complained less pain than the control group for the first 12 h after surgery , and the patients in the other groups showed less pain only during the initial 6 h after surgery .


Groups 4 and 5 also showed less opioid consumption than the control group during the 24 h period after surgery .


Patients in Group 5 showed no significant difference in VAS score and opioid consumption compared with Group 4 , but they had lower CRP value and greater ROM than any other groups at post-operative day 2 and day 4 .


The combination of ropivacaine , morphine , and ketorolac showed a significantly stronger and sufficiently synergistic analgesic effect without adding methylprednisolone in periarticular injection after TKA .


The clinical relevance of the study is that the combination of ropivacaine , morphine , and ketorolac can be a good option for periarticular injection following TKA in terms of synergistic analgesic effect and efficiency of drug combination .


Secukinumab has demonstrated high , sustained efficacy in psoriasis to 52 weeks on a fixed-interval regimen .


We sought to compare a retreatment-as-needed versus a fixed-interval regimen .


In this double-blind study , adults with moderate to severe plaque psoriasis were randomized 1:1 to subcutaneous secukinumab at 300 mg ( n = 484 ) or 150 mg ( n = 482 ) weekly from baseline until week 4 , and at week 8 .


At week 12 , patients achieving 75 % or more improvement from baseline Psoriasis Area and Severity Index score ( PASI 75 ) were rerandomized to 2 dose levels of secukinumab retreatment as needed ( n = 217 , 300 mg ; n = 206 , 150 mg ) or fixed interval ( n = 217 ; n = 203 ) .


Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI 75 to week 52 .


Secukinumab induced high responses by week 12 ( 84.4 % -91.1 % PASI 75 responders ) .


From week 12 to week 52 , more patients on fixed interval ( 78.2 % , 300 mg ; 62.1 % , 150 mg ) maintained PASI 75 versus retreatment as needed ( 67.7 % ; 52.4 % ) ; statistical noninferiority of retreatment as needed was not established .


Overall safety , including very low incidences of treatment-emergent anti-drug antibodies ( < 0.5 % ) , was similar between regimens .


The primary end point was developed without any known precedent .


Secukinumab fixed interval showed clear benefit versus the study-specified retreatment-as-needed regimen for maintaining efficacy .


Both regimens exhibited safety consistent with previous trials .


The potential of retreatment as needed with secukinumab warrants further investigation .


The purpose of this study was to quantify the frequency and clinical severity of quality deficiencies in intensity modulated radiation therapy ( IMRT ) planning in the Radiation Therapy Oncology Group 0126 protocol .


A total of 219 IMRT patients from the high-dose arm ( 79.2 Gy ) of RTOG 0126 were analyzed .


To quantify plan quality , we used established knowledge-based methods for patient-specific dose-volume histogram ( DVH ) prediction of organs at risk and a Lyman-Kutcher-Burman ( LKB ) model for grade 2 rectal complications to convert DVHs into normal tissue complication probabilities ( NTCPs ) .


The LKB model was validated by fitting dose-response parameters relative to observed toxicities .


The 90th percentile ( 22 of 219 ) of plans with the lowest excess risk ( difference between clinical and model-predicted NTCP ) were used to create a model for the presumed best practices in the protocol ( pDVH0126 , top10 % ) .


Applying the resultant model to the entire sample enabled comparisons between DVHs that patients could have received to DVHs they actually received .


Excess risk quantified the clinical impact of suboptimal planning .


Accuracy of pDVH predictions was validated by replanning 30 of 219 patients ( 13.7 % ) , including equal numbers of presumed `` high-quality , '' `` low-quality , '' and randomly sampled plans .


NTCP-predicted toxicities were compared to adverse events on protocol .


Existing models showed that bladder-sparing variations were less prevalent than rectum quality variations and that increased rectal sparing was not correlated with target metrics ( dose received by 98 % and 2 % of the PTV , respectively ) .


Observed toxicities were consistent with current LKB parameters .


Converting DVH and pDVH0126 , top10 % to rectal NTCPs , we observed 94 of 219 patients ( 42.9 % ) with 5 % excess risk , 20 of 219 patients ( 9.1 % ) with 10 % excess risk , and 2 of 219 patients ( 0.9 % ) with 15 % excess risk .


Replanning demonstrated the predicted NTCP reductions while maintaining the volume of the PTV receiving prescription dose .


An equivalent sample of high-quality plans showed fewer toxicities than low-quality plans , 6 of 73 versus 10 of 73 respectively , although these differences were not significant ( P = .21 ) due to insufficient statistical power in this retrospective study .


Plan quality deficiencies in RTOG 0126 exposed patients to substantial excess risk for rectal complications .


Transfer patterns , procedure rates , and outcomes of patients with non-ST-segment elevation myocardial infarction ( NSTEMI ) presenting to Canadian community hospitals are not well understood .


We documented all patients admitted to British Columbia ( BC ) hospitals with a primary diagnosis of NSTEMI between 2007 and 2008 .


Patients were divided by admitting hospital type into tertiary care hospitals , nonremote community hospitals , and remote community hospitals .


The aims were to compare transfer rates and time to transfer to a tertiary hospital as well as procedure rates and outcomes at index admission , at 30 days , and at 1 year .


The mean transfer rates to a tertiary hospital were 72.6 % for nonremote and 57.1 % for remote community hospitals ( P < 0.001 ) .


Times to and rates of cardiac procedures differed significantly among these 3 hospital types .


Admission to a nonremote or remote community hospital was associated with similar 1-year mortality compared with admission to a tertiary care hospital ( nonremote hospitals , adjusted odds ratio [ OR ] , 0.87 ; P = 0.26 ; remote hospitals , adjusted OR , 1.19 ; P = 0.33 ) .


At 1 year , admission to a nonremote community hospital was associated with a lower composite outcome of death or readmission for acute myocardial infarction ( AMI ) ( adjusted OR , 0.80 ; P = 0.04 ) .


One-year mortality rates were not different between patients with NSTEMI admitted to BC community and tertiary care hospitals ; however , the rate of readmission for AMI/death was significantly less in patients admitted to nonremote community hospitals .


This should prompt the evaluation of key outcomes in NSTEMI in other community hospital settings .


There is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis ( JIA ) .


This multicentre randomised controlled trial aimed to determine whether preformed foot orthoses ( FOs ) impacted on pain and quality of life ( QoL ) in children with JIA .


Eligible children were randomised to receive either ` fitted ' FOs with customised chair-side corrections or ` control ' FOs made without corrections .


Changes in pain and QoL were measured using a visual analogue scale and Paediatric Quality of Life questionnaire , respectively .


JIA children were assessed at baseline , 3 months and 6 months .


60 children were recruited .


179 out of a possible 180 assessments ( 99.4 % ) were completed .


A statistically significant greater difference in pain reduction ( baseline - 6 months ) was seen between the two groups favouring fitted FOs ( p = 0.029 ) .


The reduction in pain in the fitted FOs group was clinically important ( 8 mm ) .


Significant differences in QoL favouring fitted FOs were also identified as measured by the children and independently by their parents/carers .


Fitted FOs may reduce pain and improve QoL in selected children with JIA .


NCT02001844 .


Edgewise fixed orthodontic appliances are available in two different bracket slot sizes ( 0.018 and 0.022 inch ) .


Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages of one system over the other .


However , the scientific evidence supporting this area is scarce and weak .


This leaves the clinician 's choice of bracket slot system to clinical preference .


We aim to compare the 0.018-inch and 0.022-inch pre-adjusted bracket slot systems in terms of the effectiveness of orthodontic treatment .


This is a prospective , multicenter , randomized clinical trial , undertaken in the secondary care hospital environment in the NHS Tayside region of Scotland ( United Kingdom ) .


A total of 216 orthodontic patients will be recruited in three centers in secondary care hospitals in NHS Tayside .


The participants will be randomly allocated to treatment with either the 0.018-inch or 0.022-inch bracket slot systems ( n = 108 for each group ) using Victory series conventional pre-adjusted bracket systems ( 3 M Unitek , Monrovia , United States ) .


Baseline records and outcome data collected during and at the end of orthodontic treatment will be assessed .


The primary outcome measures will be the duration of orthodontic treatment in the maxillary and mandibular arches .


The secondary outcome measures will be the number of scheduled appointments for orthodontic treatment in the maxillary and mandibular arches , treatment outcome using Peer Assessment Rating index ( PAR ) , orthodontically induced inflammatory root resorption ( as measured using periapical radiographs ) and the patient 's perception of wearing orthodontic appliances .


The results from the current study will serve as evidence to guide the clinician in deciding whether the difference in bracket slot size has a significant impact on the effectiveness of orthodontic treatment .


Registered with ClinicalTrials.gov on 5 March 2014 , registration number : NCT02080338 .


Compare the effectiveness of Papacarie gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time , clinical aspects and radiographic findings .


A randomized controlled clinical trial with a split-mouth design was carried out .


The sample was composed of 20 children aged four to seven years , in whom 40 deciduous teeth were randomly divided into two groups : chemo-mechanical caries removal with Papacarie and removal of carious dentin with a low-speed bur .


Each child underwent both procedures and served as his/her own control .


Restorations were performed with glass ionomer cement .


The time required to perform the procedure was also analyzed .


The patients underwent longitudinal clinical and radiographic follow-up of the restorations .


No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up .


Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment .


Papacarie is as effective as the traditional method for the removal of carious dentin on deciduous teeth , but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia .


To examine whether hippotherapy has a clinically significant effect on gross motor function in children with cerebral palsy ( CP ) .


Randomized controlled trial .


Outpatient therapy center .


Ninety-two children with CP , aged 4-10 years , presenting variable function ( Gross Motor Function Classification System [ GMFCS ] levels I-IV ) .


Hippotherapy ( 30 minutes twice weekly for 8 consecutive weeks ) .


Gross Motor Function Measure ( GMFM ) -88 , GMFM-66 , and Pediatric Balance Scale .


Pre - and post-treatment measures were completed by 91 children ( 45 in the intervention group and 46 in the control group ) .


Differences in improvement on all three measures significantly differed between groups after the 8-week study period .


Dimensions of GMFM-88 improved significantly after hippotherapy varied by GMFCS level : dimension E in level I , dimensions D and E in level II , dimensions C and D in level III , and dimensions B and C in level IV .


Hippotherapy positively affects gross motor function and balance in children with CP of various functional levels .


Treatment options for plantar fasciitis have resulted in varied patient outcomes .


The aim of this study was to compare a novel treatment , cryopreserved human amniotic membrane ( c-hAM ) , to a traditional treatment , corticosteroid .


Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes .


A randomized , controlled , double-blind , single-center pilot study was completed .


Patients were randomized into one of 2 treatment groups : c-hAM or corticosteroid .


Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up .


Total follow-up was obtained for 12 weeks after the most recent injection .


The primary outcome measurement was the Foot Health Status Questionnaire ( FHSQ ) .


The secondary outcome measurements were the Visual Analog Scale ( VAS ) and verbally reported percentage improvement .


Data were analyzed between groups for the 2 different cohorts ( 1 injection versus 2 injections ) .


Twenty-three patients had complete follow-up .


Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM .


Three patients in each group received second injections .


With the numbers available , the majority of outcome measurements showed no statistical difference between groups .


The corticosteroid did , however , have greater FHSQ shoe fit improvement ( P = .0244 ) at 6 weeks , FHSQ general health improvement ( P = .0132 ) at 6 weeks , and verbally reported improvement ( P = .041 ) at 12 weeks in the one-injection cohort .


Cryopreserved hAM had greater FHSQ foot pain improvement ( P = .0113 ) at 18 weeks in the 2-injection cohort .


Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis .


This is a pilot study and requires further investigation .


Level I , prospective randomized trial .


Placing a central venous access device via the internal jugular or subclavian vein entails significant risks to both patient and healthcare worker .


The purpose of this randomized , prospective study was to determine whether the accelerated Seldinger technique ( AST ) offers significant safety advantages over the modified Seldinger technique ( MST ) for peripherally inserted central catheter insertion .


Patients were randomly assigned to undergo introducer sheath insertion by means of either MST or AST .


Primary outcome measures included time to completion of introducer sheath insertion , estimated blood loss , and success rate .


Secondary outcome measures included vessel-to-air exposure events and unprotected sharps exposure .


While both insertion methods proved equivalent for successful vessel cannulation , AST was significantly faster ( P = 0.0048 ) and resulted in less blood loss ( P = 0.0295 ) than MST .


Additionally , AST resulted in significantly fewer vessel-to-air exposure events ( P < 0.0001 ) and unprotected sharps exposures ( P < 0.0001 ) .


Although this was a relatively small and unblinded study , the high degree of statistical significance of the study results suggests that , for both patients and healthcare workers , AST is faster and safer than MST for PICC peelable introducer sheath insertion .


A significant proportion of patients with rheumatoid arthritis do not respond adequately to biologic treatment .


We hypothesized that lack of response to ( biologic ) disease-modifying antirheumatic drugs ( DMARDs ) is high in patients in whom the subjective , patient-reported component of the Disease Activity Score 28 ( DAS28 ) is high at baseline .


The primary aim of our present study was to investigate the contribution of the more subjective versus the objective components of the DAS28 to response to biologic agents in RA patients , as well as the changes in this contribution over time .


The secondary aim was to examine whether the value of this subjective contribution at baseline affects the response to treatment .


The DAS28-P ( the subjective components of the DAS28 relative to the total DAS28 ) was calculated .


Patients were derived from the computer-assisted Management in Early Rheumatoid Arthritis Trial-II and the Biologicals and Outcome Compared and Predicted in Utrecht Region in Rheumatoid Arthritis Study .


Ordinal logistic regression analyses were performed .


The DAS28-P score at baseline was not associated with the level of response according to European League Against Rheumatism criteria at 3 months .


Overall , a significant reduction in the DAS28-P score was observed 3 months after start of treatment , showing a greater reduction of the combined subjective components in good responders .


The results reject the hypothesis that the lack of response to biologic DMARDs is especially high in patients in whom the patient-reported component of the DAS28 is high at baseline ; these subjective components are not linked to treatment response .


Coordination between breathing and swallowing helps prevent aspiration of foreign material into the respiratory tract .


The authors examined the effects of anesthesia and hypercapnia on swallowing-breathing coordination .


In a randomized controlled crossover study , general anesthesia with propofol or sevoflurane was titrated using an up-down method to identify the threshold for suppression of the motor response to electrical stimulation of the forearm .


Additional measurements included bispectral index , genioglossus electromyogram , ventilation ( pneumotachometer ) , and hypopharyngeal pressure .


During wakefulness and at each level of anesthesia , carbon dioxide was added to increase the end-tidal pressure by 4 and 8 mmHg .


A swallow was defined as increased genioglossus activity with deglutition apnea and an increase in hypopharyngeal pressure .


Spontaneous swallows were categorized as physiological ( during expiration or followed by expiration ) or pathological ( during inspiration or followed by an inspiration ) .


A total of 224 swallows were analyzed .


Anesthesia increased the proportion of pathological swallows ( 25.9 % vs. 4.9 % ) and decreased the number of swallows per hour ( 1.73.3 vs. 28.022.3 ) compared to wakefulness .


During anesthesia , hypercapnia decreased hypopharyngeal pressure during inspiration ( -14.13.7 vs. -8.72 mmHg ) and increased minute ventilation , the proportion of pathological swallows ( 19.1 % vs. 12.3 % ) , and the number of swallows per hour ( 5.517.0 .


vs. 1.35.5 ) .


Anesthesia impaired the coordination between swallowing and respiration .


Mild hypercapnia increased the frequency of swallowing during anesthesia and the likelihood of pathological swallowing .


During anesthesia , the risk for aspiration may be further increased when ventilatory drive is stimulated .


In ruminants , lower ruminal pH causes massive disruption of ruminal epithelial structure during periods of feeding high-concentrate diets .


However , the influence of excessive organic fatty acids in the lumen of hindgut on the epithelial structure is unclear .


In this study , twelve mid-lactating goats were randomly assigned to either a HC diet group ( 65 % concentrate of dry matter ; n = 6 ) or a LC diet group ( 35 % concentrate of dry matter ; n = 6 ) for 10 weeks .


The colonic epithelial structure was detected by HE staining and transmission electron microscopy ( TEM ) , and the apoptotic status of epithelial cells was estimated by TUNEL method and caspase activities .


HC goats showed higher level of free lipopolysaccharide ( LPS ) in rumen fluid ( p < 0.01 ) but not in colonic digesta ( p > 0.05 ) , and higher total volatile fatty acid ( VFA ) concentrations in rumen fluid ( p < 0.05 ) and in colonic digesta ( p < 0.01 ) , and higher content of starch in colonic digesta ( p < 0.05 ) compared to LC goats .


HC goats demonstrated profound alterations in the colonic epithelial structure and tight junctions ( TJ ) , apparently due to damage of the epithelium with widened TJs space and nuclear breakdown and mitochondrial swelling .


HC goats showed higher level of apoptosis in the colonic epithelium with higher proportion of TUNEL-positive apoptotic cells and increases of caspase-3 and -3 / 7 activities , as well as the lower ratio of bcl-2 / bax mRNA expression in the colonic mucosa ( p < 0.05 ) .


However , - defense mRNA was significantly down-regulated in the colonic mucosa of HC goats compared to LC ( p < 0.05 ) .


HC goats showed higher level of TJ proteins including claudin-1 and claudin-4 in the colonic mucosa than LC ( p < 0.05 ) .


Neither free LPS content in the colonic digesta nor NF - B protein expression in tissues showed significant difference between HC and LC goats ( p > 0.05 ) .


Our results reveal that long-term feeding HC diet to lactating goats causes severe damages to the colonic mucosa barrier associated with activating cells apoptosis .


Earlier kinetics of serum HCV core antigen ( HCVcAg ) and its predictive value on sustained virological response ( SVR ) were investigated in patients with genotype 1 HCV infection during antiviral treatment .


In a multi-centered , randomized and positive drug-controlled phase IIb clinical trial on type Y peginterferon -2 b ( NCT01140997 ) , forty-eight CHC patients who participated in pharmacokinetics were randomly divided into 4 cohorts and treated with PegIFN ( type Y peginterferon -2 b 90 g , 135 g , 180 g and PegIFN-2a 180 g , respectively , once a week ) and ribavirin ( < 75 kg , 1000 mg daily and75 kg , 1200 mg daily ) for 48 weeks , and then followed up for 24 weeks .


32 patients infected with genotype 1 HCV and completed the whole process were included in this study .


HCV RNAs were detected at baseline , and weeks 4 , 12 , 24 , 48 and 72 using Cobas TaqMan .


ARCHITECT HCVcAg was performed at 24 , 48 , 72 , 96 , 120 and 144 h in addition to the above time points .


The receiver operating curves ( ROCs ) were performed to study the predictive values of HCVcAg decline on SVR .


Following antiviral treatment , serum HCVcAg levels rapidly declined within the first week and correlated well with corresponding HCV RNA at baseline , weeks 4 , 12 , 24 , 48 and 72 ( rs = 0.969 , 0.928 , 0.999 , 0.983 , 0.985 and 0.946 , respectively , P < 0.001 ) .


All of the areas under the receiver operating curves ( AUROCs ) were more than 0.80 and showed good predictive power on SVR at 24 , 48 , 72 , 96 , 120 and 144 h. The144 h was the best predictive time point of HCVcAg decline on SVR because of its largest AUROC ( more than 0.90 ) .


Early kinetics of serum HCVcAg predicts SVR very well in genotype 1 CHC patients during antiviral treatment , and its reduction value at 144 h is an earlier and stronger predictor on SVR than rapid virological response and early virological response .


( TRN : NCT01140997 ) .


The pectoral nerves ( Pecs ) block types I and II are novel techniques to block the pectoral , intercostobrachial , third to sixth intercostals , and the long thoracic nerves .


They may provide good analgesia during and after breast surgery .


Our study aimed to compare prospectively the quality of analgesia after modified radical mastectomy surgery using general anesthesia and Pecs blocks versus general anesthesia alone .


One hundred twenty adult female patients scheduled for elective unilateral modified radical mastectomy under general anesthesia were randomly allocated to receive either general anesthesia plus Pecs block ( Pecs group , n = 60 ) or general anesthesia alone ( control group , n = 60 ) .


Statistically significant lower visual analog scale pain scores were observed in the Pecs group than in the control group patients .


Moreover , postoperative morphine consumption in the Pecs group was lower in the first 12 hours after surgery than in the control group .


In addition , statistically significant lower intraoperative fentanyl consumption was observed in the Pecs group than in the control group .


In the postanesthesia care unit , nausea and vomiting as well as sedation scores were lower in the Pecs group compared with the control group .


Overall , postanesthesia care unit and hospital stays were shorter in the Pecs group than in the control group .


The combined Pecs I and II block is a simple , easy-to-learn technique that produces good analgesia for radical breast surgery .


To investigate the effects of different types of nasal packings on middle ear pressure in patients undergoing septoplasty .


Sixty patients who were suffering from nasal obstruction and who had to undergo septoplasty because of nasal septal deviation were included in the study .


After the septoplasty , Merocel packings and internal nasal splints were intraoperatively applied in thirty patients each .


Middle ear pressure was evaluated by tympanometry .


Tympanometric peak pressures were used for this aim .


Acoustic impedance measurements were performed in both ears , and the average values of the two ears were calculated .


Tympanometric measurements were performed for patients during the preoperative period and on the 2 ( nd ) and 5 ( th ) postoperative days .


There were 30 ( 5 females , 25 males ; average age 23 years ) patients in the internal nasal splint group and 30 ( 8 females , 22 males ; average age 26 years ) patients in the anterior Merocel packing group .


When the values obtained by acoustic impedancemetry before the operation and on the postoperative 5 ( th ) day were compared , there was no statistically significant difference between the groups .


The middle ear pressure significantly decreased in the anterior Merocel packing group compared with that in the internal nasal splint group .


The intragroup comparison of the acoustic impedance measurements of the internal nasal splint group revealed no significant difference between the preoperative acoustic impedance values and the values obtained on the postoperative 2 ( nd ) day .


Cannulated silicone intranasal splints are better in terms of patient comfort after an intranasal surgery without effecting eustachian tube function .


Cerebral palsy refers to permanent , mutable motor development disorders stemming from a primary brain lesion , causing secondary musculoskeletal problems and limitations in activities of daily living .


The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy .


A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups ( blocks of six and stratified based on GMFCS level ( levels I-II or level III ) .


The experimental group ( 12 children ) was submitted to treadmill training and anodal stimulation of the primary motor cortex .


The control group ( 12 children ) was submitted to treadmill training and placebo transcranial direct-current stimulation .


Training was performed in five weekly sessions for 2 weeks .


Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention , one week after the completion of the intervention and one month after the completion of the intervention .


All patients and two examiners were blinded to the allocation of the children to the different groups .


The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway ( eyes open and closed ; p < 0.05 ) , mediolateral sway ( eyes closed ; p < 0.05 ) and the Pediatric Balance Scale both one week and one month after the completion of the protocol .


Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy .


Ensaiosclinicos.gov.br / RBR-9B5DH7 .


To determine the effects of dexmedetomidine premedication on the minimum alveolar concentration of sevoflurane for tracheal intubation ( MACTI ) in children .


Prospective , randomized , clinical comparison study .


Operating room of an academic hospital .


90 pediatric , ASA physical status 1 patients , aged 3 to 7 years , scheduled for minor elective surgery .


Patients were randomized to three groups to receive placebo , dexmedetomidine 1 g/kg , or dexmedetomidine 2 g/kg approximately 60 minutes before anesthesia .


Anesthesia was induced with sevoflurane .


Each concentration of sevoflurane for which a tracheal intubation was attempted was predetermined according to modification of the Dixon 's up-and-down method , with 0.25 % as a step size and held constant for at least 15 minutes before tracheal intubation .


All responses ( `` movement '' or `` no movement '' ) to tracheal intubation were assessed .


The MACTI of sevoflurane was 2.82 % 0.17 % in the control group , 2.26 % 0.18 % in the 1 g/kg dexmedetomidine group , and 1.83 % 0.16 % in the 2 g/kg dexmedetomidine group .


Dexmedetomidine premedication ( 1 and 2 g/kg ) decreased the MACTI of sevoflurane by 20 % and 35 % , respectively .


There were no clinically significant episodes of hypotension or bradycardia in any patients .


Intranasal dexmedetomidine premedication produces a dose-dependent decrease in the concentration of sevoflurane needed for tracheal intubation in children .


To examine the effect of weight loss on sleep duration , sleep quality , and mood in 390 obese men and women who received one of three behavioral weight loss interventions in the Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania ( POWER-UP ) .


Sleep duration and quality were assessed at baseline and months 6 and 24 by the Pittsburgh Sleep Quality Index ( PSQI ) questionnaire and mood by the Patient Health Questionnaire-8 ( PHQ-8 ) .


Changes in sleep and mood were examined according to treatment group and based on participants ' having lost 5 % of initial weight vs. < 5 % .


There were few significant differences between treatment groups in changes in sleep or mood .


At month 6 , however , mean ( SD ) min of sleep increased significantly more in participants who lost 5 % vs. < 5 % ( 21.67.2 vs. 1.26.0 min , P = 0.0031 ) .


PSQI total scores similarly improved ( declined ) more in those who lost 5 % vs. < 5 % ( -1.20.2 vs. -0.40.2 , P < 0.001 ) , as did PHQ-8 scores ( -2.50.4 vs. -0.10.3 , P < 0.0001 ) .


At month 24 , only the differences in mood remained statistically significant ( P < 0.05 ) .


Losing 5 % of initial weight was associated with short-term improvements in sleep duration and sleep quality , as well as favorable short - and long-term changes in mood .


The STRIDE study assessed whether a lifestyle intervention , tailored for individuals with serious mental illnesses , reduced weight and diabetes risk .


The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism .


The study design was a multisite , parallel two-arm randomized controlled trial in community settings and an integrated health plan .


Participants who met inclusion criteria were 18 years old , were taking antipsychotic agents for 30 days , and had a body mass index 27 .


Exclusions were significant cognitive impairment , pregnancy/breastfeeding , recent psychiatric hospitalization , bariatric surgery , cancer , heart attack , or stroke .


The intervention emphasized moderate caloric reduction , the DASH ( Dietary Approaches to Stop Hypertension ) diet , and physical activity .


Blinded staff collected data at baseline , 6 months , and 12 months .


Participants ( men , N = 56 ; women , N = 144 ; mean age = 47.2 years [ SD = 10.6 ] ) were randomly assigned to usual care ( N = 96 ) or a 6-month weekly group intervention plus six monthly maintenance sessions ( N = 104 ) .


A total of 181 participants ( 90.5 % ) completed 6-month assessments , and 170 ( 85 % ) completed 12-month assessments , without differential attrition .


Participants attended 14.5 of 24 sessions over 6 months .


Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months ( 95 % CI = -6.96 kg to -1.78 kg ) and 2.6 kg more than control participants from baseline to 12 months ( 95 % CI = -5.14 kg to -0.07 kg ) .


At 12 months , fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL .


No serious adverse events were study-related ; medical hospitalizations were reduced in the intervention group ( 6.7 % ) compared with the control group ( 18.8 % ) .


Individuals taking antipsychotic medications can lose weight and improve fasting glucose levels .


Increasing reach of the intervention is an important future step .


Verbal autopsy ( VA ) has been proposed to determine the cause of death ( COD ) distributions in settings where most deaths occur without medical attention or certification .


We develop performance criteria for VA-based COD systems and apply these to the Registrar General of India 's ongoing , nationally-representative Indian Million Death Study ( MDS ) .


Performance criteria include a low ill-defined proportion of deaths before old age ; reproducibility , including consistency of COD distributions with independent resampling ; differences in COD distribution of hospital , home , urban or rural deaths ; age - , sex - and time-specific plausibility of specific diseases ; stability and repeatability of dual physician coding ; and the ability of the mortality classification system to capture a wide range of conditions .


The introduction of the MDS in India reduced the proportion of ill-defined deaths before age 70 years from 13 % to 4 % .


The cause-specific mortality fractions ( CSMFs ) at ages 5 to 69 years for independently resampled deaths and the MDS were very similar across 19 disease categories .


By contrast , CSMFs at these ages differed between hospital and home deaths and between urban and rural deaths .


Thus , reliance mostly on urban or hospital data can distort national estimates of CODs .


Age - , sex - and time-specific patterns for various diseases were plausible .


Initial physician agreement on COD occurred about two-thirds of the time .


The MDS COD classification system was able to capture more eligible records than alternative classification systems .


By these metrics , the Indian MDS performs well for deaths prior to age 70 years .


The key implication for low - and middle-income countries where medical certification of death remains uncommon is to implement COD surveys that randomly sample all deaths , use simple but high-quality field work with built-in resampling , and use electronic rather than paper systems to expedite field work and coding .


Simple criteria can evaluate the performance of VA-based COD systems .


Despite the misclassification of VA , the MDS demonstrates that national surveys of CODs using VA are an order of magnitude better than the limited COD data previously available .


Depression accounts for the greatest disease burden of all mental health disorders , contributes heavily to healthcare costs , and by 2020 is set to become the second largest cause of global disability .


Although 10 % to 16 % of people aged 65 years and over are likely to experience depressive symptoms , the condition is under-diagnosed and often inadequately treated in primary care .


Later-life depression is associated with chronic illness and disability , cognitive impairment and social isolation .


With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people .


Currently , management may be limited to the prescription of antidepressants where there may be poor concordance ; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option .


CASPER Plus is a multi-centre , randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression .


Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study .


A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care .


The recruitment target is 450 participants .


The intervention , behavioural activation and medication management in a collaborative care framework , has been adapted to meet the complex needs of older people .


It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners .


The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone .


The primary clinical outcome , depression severity , will be measured with the Patient Health Questionnaire-9 ( PHQ-9 ) at baseline , 4 , 12 and 18 months .


Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care .


A qualitative process evaluation will be undertaken to explore acceptability , gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial .


Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care .


ISRCTN45842879 ( 24 July 2012 ) .


Endoscopic placement of a iodine-125 radioactive stent is useful to treat obstructive jaundice with unresectable periampullary tumors .


This study aimed to retrospectively evaluate the obstructive component of biliary radioactive stents and discuss the different obstructive mechanism with common plastic stents .


Twenty consecutive patients with malignant obstruction underwent insertion of stents into the common bile duct , including 10 radioactive stents and 10 polyethylene stents .


The radioactive stents were withdrawn after 3 months or earlier if clinical signs suggested stent clogging .


Polyethylene stents were withdrawn after physical signs suggested stent clogging .


Bacteriologic analyses included identification of aerobic and anaerobic bacteria .


Stent surfaces were observed by scanning electron microscopy .


Stent deposition was identified by Fourier-transformed infrared spectroscopy and pyrolysis derivatization/gas chromatography/mass spectrometry .


Radioactive stent group and polyethylene stent group stents were placed for 86 days ( interquartile range 62 , 114 ) and 146 days ( interquartile range 105 , 181 ) respectively .


The placement duration of the two types of stents was statistically significant .


A variety of microorganisms were cultured from the stent deposits .


Scanning electron microscope images showed a thicker necrotic layer on the external surface of polyethylene stent than the radioactive stent group .


The proportions of obstructive components in each stent were different , but none of them were statistically significant .


Necrotic tumor tissue was found in the radioactive stent group .


Similar clogging events occurred in both radioactive stents and polyethylene stents .


The median duration time of the radioactive stent was shorter , probably because of the smaller inner diameter , and the radioactive seeds exerted no beneficial effect in inhibiting microorganisms .


Previous studies on cognitive and interpersonal interventions have yielded inconsistent results in ischemic heart disease patients .


101 patients aged 70 years , and enrolled one week after complete revascularization with urgent/emergent angioplasty for an AMI , were randomized to standard cardiological therapy plus short-term humanistic-existential psychotherapy ( STP ) versus standard cardiological therapy only .


Primary composite end point was : one-year incidence of new cardiological events ( re-infarction , death , stroke , revascularization , life-threatening ventricular arrhythmias , and the recurrence of typical and clinically significant angina ) and of clinically significant new comorbidities .


Secondary end points were : rates for individual components of the primary outcome , incidence of re-hospitalizations for cardiological problems , New York Heart Association class , and psychometric test scores at follow-up .


94 patients were analyzed at one year .


The two treatment groups were similar across all baseline characteristics .


At follow-up , STP patients had had a lower incidence of the primary endpoint , relative to controls ( 21/49 vs. 35/45 patients ; p = 0.0006 , respectively ; NNT = 3 ) ; this benefit was attributable to the lower incidence of recurrent angina and of new comorbidities in the STP group ( 14/49 vs. 22/45 patients , p = 0.04 , NNT = 5 ; and 5/49 vs. 25/45 , p < 0.0001 , NNT = 3 , respectively ) .


Patients undergoing STP also had statistically fewer re-hospitalizations , a better NYHA class , higher quality of life , and lower depression scores .


Adding STP to cardiological therapy improves cardiological symptoms , quality of life , and psychological and medical outcomes one year post AMI , while reducing the need for re-hospitalizations .


Larger studies remain necessary to confirm the generalizability of these results .


ClinicalTrial.gov : NCT00769366 .


Noroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality .


A randomized , double-blind , placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle ( VLP ) vaccine .


Forty-eight adults aged 18-49 years received either 2 doses containing genotype GI .1 VLP and a consensus GII .4 VLP or 2 doses of placebo .


Doses ( 5 g , 15 g , 50 g , or 150 g of each VLP ) were administered 4 weeks apart in the first stage .


Subsequently , 54 adults , aged 18-49 ( n = 16 ) , 50-64 ( n = 19 ) , and 65-85 ( n = 19 ) years , received 2 doses of vaccine containing 50 g of each VLP .


Total and class-specific antibody responses , as well as histoblood group antigen ( HBGA ) blocking antibody responses , were measured before and after each dose .


Local reactions were mainly injection site pain/tenderness , with no reported fever or vaccine-related serious adverse events .


One dose of vaccine containing 50 g of each VLP increased GI .1 geometric mean titers ( GMTs ) by 118-fold , 83-fold , and 24-fold and increased GII .4 GMTs by 49-fold , 25-fold , and 9-fold in subjects aged 18-49 , 50-64 , and 65-83 years , respectively .


Serum antibody responses peaked at day 7 after the first dose , with no evidence of boosting following a second dose .


Most subjects achieved HBGA-blocking antibody titers of 200 .


The vaccine was well tolerated and immunogenic .


Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks .


Clinical Trials Registration.NCT01168401 .


The threshold values of rapid shallow breathing index ( RSBI ) were compared in pressure support ventilation ( PSV ) and T-piece assessments for spontaneous breathing trials ( SBT ) .


The ability of RSBI to also predict successful weaning was evaluated .


Two hundred eight patients were weaned from mechanical ventilation through oral intubation .


They were randomly divided into PSV group ( n = 93 ) and T-piece group ( n = 115 ) .


The RSBI was calculated as f/VT at SBT of 3 and 30 minutes .


Receiver operating characteristic curves of RSBI were also generated , cutoff values were determined and the changes in the RSBI were calculated .


Of the 208 patients , 168 ( 80.77 % ) were successfully weaned from mechanical ventilation , 78/93 ( 83.9 % ) in the PSV group and 90/115 ( 78.3 % ) in the T-piece group ( P > 0.05 ) .


In the PSV and T-piece groups , the average RSBI at 30-minute SBT was 67.18 11.55 breaths per min/L and 99.11 15.53 breaths per min/L , respectively ( P < 0.01 ) , and the average RSBI was 69 33 % and 119 35 % , respectively ( P < 0.01 ) .


Additionally , in the 2 groups , an RSBI of 75 breaths per min/L ( PSV ) and 100 breaths per min/L ( T-piece ) yielded a diagnostic accuracy of 87 % and 82 % respectively .


However , a RSBI of 90 % ( PSV ) and 130 % ( T-piece ) yielded a diagnostic accuracy of 82 % and 77 % respectively .


The threshold values of RSBI , thus 75 breaths per min/L ( PSV ) and 100 breaths per min/L ( T-piece ) , for predicting successful weaning were more accurate than other values .


Similarly , the change in the RSBI could also predict such successes .


Continuous long-term treatment with nitrates may cause nitrate tolerance .


Nebivolol is a highly selective beta1-adrenergic antagonist with additional nitric oxide ( NO ) - mediated vasodilatory effects .


However , there have been no investigations into whether or not the long-term administration of nebivolol might cause nitrate tolerance .


We performed a randomized , double-blind , placebo-controlled , cross-over study in 16 healthy men .


Subjects received 5 mg nebivolol or placebo once daily for 8 days in random order divided by a drug-free interval of 2 weeks .


Forearm blood flow ( FBF ) was measured by venous occlusion plethysmography 3 h after oral intake of the first and last doses of nebivolol and placebo , respectively .


FBF was measured again following the intravenous administration of 4 g nitroglycerin/kg body weight/min for 5 min .


Following 8 days of continuous intake of placebo , nitroglycerin increased FBF by 54 % ( p < 0.05 ) , whereas nitroglycerin increased FBF by 96 % ( p < 0.01 ) following 8 days of continuous intake of nebivolol , and the increase after 8 days of nebivolol was significantly ( p < 0.05 ) more pronounced than after 8 days of placebo .


These findings indicate no evidence of nitrate tolerance caused by long-term administration of nebivolol .


On the contrary , long-term intake of nebivolol increases rather than decreases the NO-mediated vasodilating effects .


Most patients with extensive stage small-cell lung cancer ( ES-SCLC ) who undergo chemotherapy , and prophylactic cranial irradiation , have persistent intrathoracic disease .


We assessed thoracic radiotherapy for treatment of this patient group .


We did this phase 3 randomised controlled trial at 42 hospitals : 16 in Netherlands , 22 in the UK , three in Norway , and one in Belgium .


We enrolled patients with WHO performance score 0-2 and confirmed ES-SCLC who responded to chemotherapy .


They were randomly assigned ( 1:1 ) to receive either thoracic radiotherapy ( 30 Gy in ten fractions ) or no thoracic radiotherapy .


All underwent prophylactic cranial irradiation .


The primary endpoint was overall survival at 1 year in the intention-to-treat population .


Secondary endpoints included progression-free survival .


This study is registered with the Nederlands Trial Register , number NTR1527 .


We randomly assigned 498 patients between Feb 18 , 2009 , and Dec 21 , 2012 .


Three withdrew informed consent , leaving 247 patients in the thoracic radiotherapy group and 248 in the control group .


Mean interval between diagnosis and randomisation was 17 weeks .


Median follow-up was 24 months .


Overall survival at 1 year was not significantly different between groups : 33 % ( 95 % CI 27-39 ) for the thoracic radiotherapy group versus 28 % ( 95 % CI 22-34 ) for the control group ( hazard ratio [ HR ] 0.84 , 95 % CI 0.69-1 .01 ; p = 0.066 ) .


However , in a secondary analysis , 2-year overall survival was 13 % ( 95 % CI 9-19 ) versus 3 % ( 95 % CI 2-8 ; p = 0.004 ) .


Progression was less likely in the thoracic radiotherapy group than in the control group ( HR 0.73 , 95 % CI 0.61-0 .87 ; p = 0.001 ) .


At 6 months , progression-free survival was 24 % ( 95 % CI 19-30 ) versus 7 % ( 95 % CI 4-11 ; p = 0.001 ) .


We recorded no severe toxic effects .


The most common grade 3 or higher toxic effects were fatigue ( 11 vs 9 ) and dyspnoea ( three vs four ) .


Thoracic radiotherapy in addition to prophylactic cranial irradiation should be considered for all patients with ES-SCLC who respond to chemotherapy .


Dutch Cancer Society ( CKTO ) , Dutch Lung Cancer Research Group , Cancer Research UK , Manchester Academic Health Science Centre Trials Coordination Unit , and the UK National Cancer Research Network .


The aim of this study was to test the efficacy of a 12-month lifestyle intervention in improving cardiovascular disease risk factors in community-based menopausal transition and early postmenopausal women in China .


One hundred healthy menopausal transition and early postmenopausal women aged 40 to 60 years were randomly assigned to receive either lifestyle change intervention ( n = 53 ) or usual care ( n = 47 ) .


Menopause status was defined by the menstrual change criteria of the Stages of Reproductive Aging Workshop + 10 based on prospective menstrual calendars .


Women in the intervention group were provided with a colorful booklet that included dietary and physical activity recommendations , were individually interviewed , and completed biophysical cardiovascular risk assessments at the Women 's Health Center ( Beijing , China ) .


Women were encouraged to follow a healthy eating pattern and to increase their aerobic activity ( moderate level , 3 d/wk , 40 min/d ) .


Women in the control group continued their usual eating patterns and activities .


Weight , body mass index ( BMI ) , waist circumference-to-hip circumference ratio ( WHR ) , waist circumference ( WC ) , body composition , blood pressure ( BP ) , blood glucose , and serum lipids were assessed at baseline , 3 months , 6 months , and 12 months in both groups .


Women in the intervention group were observed to have significant decreases in weight , BMI , WC , WHR , systolic BP , total cholesterol , and low-density lipoprotein cholesterol compared with women in the control group .


At 3 months , there were significant decreases in weight ( -0.28 vs 0.68 kg , P = 0.002 ) , BMI ( -0.06 vs 0.44 kg/m2 , P = 0.003 ) , WC ( -0.28 vs 1.43 cm , P = 0.001 ) , and WHR ( -0.01 vs 0.01 , P = 0.045 ) in the intervention group compared with the control group .


At 6 months , there were significant decreases in WC ( -0.73 vs 1.02 cm , P = 0.012 ) , WHR ( -0.02 vs -0.003 , P = 0.020 ) , and systolic BP ( -7.52 vs -0.63 mm Hg , P = 0.012 ) favoring the intervention group over the control group .


At 12 months , there were significant decreases in total cholesterol ( -0.07 vs 0.03 mmol/L , P = 0.045 ) and low-density lipoprotein cholesterol ( -0.13 vs 0.01 mmol/L , P = 0.022 ) in the intervention group versus the control group .


Lifestyle intervention may be an effective means for reducing cardiovascular disease risk factors in menopausal transition and early postmenopausal women in China .


Ninety percent of cases of acute calculous cholecystitis are of mild ( grade I ) or moderate ( grade II ) severity .


Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized , few data exist on the utility of postoperative antibiotic treatment .


To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy .


A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label , noninferiority , randomized clinical trial between May 2010 and August 2012 .


After surgery , no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days .


The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit .


An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17 % ( 35 of 207 ) in the nontreatment group and 15 % ( 31 of 207 ) in the antibiotic group ( absolute difference , 1.93 % ; 95 % CI , -8.98 % to 5.12 % ) .


In the per-protocol analysis , which involved 338 patients , the corresponding rates were both 13 % ( absolute difference , 0.3 % ; 95 % CI , -5.0 % to 6.3 % ) .


Based on a noninferiority margin of 11 % , the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment .


Bile cultures showed that 60.9 % were pathogen free .


Both groups had similar Clavien complication severity outcomes : 195 patients ( 94.2 % ) in the nontreatment group had a score of 0 to I and 2 patients ( 0.97 % ) had a score of III to V , and 182 patients ( 87.8 % ) in the antibiotic group had a score of 0 to I and 4 patients ( 1.93 % ) had a score of III to V.


Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics , lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections .


clinicaltrials.gov Identifier : NCT01015417 .


To expose residents to two methods of education for point-of-care ultrasound , a traditional didactic lecture and a model/simulation-based lecture , which focus on concepts of cardiopulmonary function , volume status , and evaluation of severe thoracic/abdominal injuries ; and to assess which method is more effective .


Single-center , prospective , blinded trial .


University hospital .


Anesthesiology residents who were assigned to an educational day during the two-month research study period .


Residents were allocated to two groups to receive either a 90-minute , one-on-one didactic lecture or a 90-minute lecture in a simulation center , during which they practiced on a human model and simulation mannequin ( normal pathology ) .


Data points included a pre-lecture multiple-choice test , post-lecture multiple-choice test , and post-lecture , human model-based examination .


Post-lecture tests were performed within three weeks of the lecture .


An experienced sonographer who was blinded to the education modality graded the model-based skill assessment examinations .


Participants completed a follow-up survey to assess the perceptions of the quality of their instruction between the two groups .


20 residents completed the study .


No differences were noted between the two groups in pre-lecture test scores ( P = 0.97 ) , but significantly higher scores for the model/simulation group occurred on both the post-lecture multiple choice ( P = 0.038 ) and post-lecture model ( P = 0.041 ) examinations .


Follow-up resident surveys showed significantly higher scores in the model/simulation group regarding overall interest in perioperative ultrasound ( P = 0.047 ) as well understanding of the physiologic concepts ( P = 0.021 ) .


A model/simulation-based based lecture series may be more effective in teaching the skills needed to perform a point-of-care ultrasound examination to anesthesiology residents .


Women in academic medicine are not achieving the same career advancement as men , and face unique challenges in managing work and family alongside intense work demands .


The purpose of this study was to investigate how a supportive department/division culture buffered women from the impact of work demands on work-to-family conflict .


As part of a larger intervention trial , the authors collected baseline survey data from 133 women assistant professors at the University of Pennsylvania Perelman School of Medicine in 2010 .


Validated measures of work demands , work-to-family conflict , and a department/division culture were employed .


Pearson correlations and general linear mixed modeling were used to analyze the data .


Authors investigated whether work culture moderated the association between work demands and work-to-family conflict .


Heavy work demands were associated with increased levels of work-to-family conflict .


There were significant interactions between work demands , work-to-family conflict , and department/division culture .


A culture conducive to women 's academic success significantly moderated the effect of work hours on time-based work-to-family conflict and significantly moderated the effect of work overload on strain-based work-to-family conflict .


At equivalent levels of work demands , women in more supportive cultures experienced lower levels of work-to-family conflict .


The culture of the department/division plays a crucial role in women 's work-to-family conflict and can exacerbate or alleviate the impact of extremely high work demands .


This finding leads to important insights about strategies for more effectively supporting the careers of women assistant professors .


The addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone .


To evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine .


Eleven healthy volunteers ( 24-30 years-old ) were randomized in a crossover fashion to intake 400 mL ( 4h before ) and 200 mL ( 2h before ) of a beverage containing either 12.5 % maltodextrin ( carbohydrate group ) or 12.5 % maltodextrin plus 15 g of glutamine ( glutamine group ) in two different moments 7 days apart .


Magnetic ressonance was performed to measure the gastric residual volume ( mL ) 120 and 180 minutes after the last ingestion .


Gastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages .


There was no difference in the mean SD GRV ( mL ) found at 120 minutes ( carbohydrate group : 22.916.6 and glutamine group : 19.710.7 ) and at 180 minutes ( carbohydrate group : 21.524.1 and glutamine group : 15.110.1 ) between the two drinks .


Gastric emptying is efficient , and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine .


The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation .


Little is known about how different antiretrovirals effect inflammation and monocyte activation in human immunodeficiency virus ( HIV ) infection .


We examined plasma specimens obtained during a randomized , double-blinded trial in antiretroviral therapy ( ART ) - naive HIV-infected adults which compared the efficacy of elvitegravir/cobicistat/emtricitabine / tenofovir disoproxil fumarate ( EVG/c/FTC / TDF ) with that of efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF ) .


From a random sample achieving an HIV type 1 RNA load of < 50 copies/mL by week 48 , changes over 24 and 48 weeks in levels of biomarkers of monocyte activation ( soluble CD14 [ sCD14 ] and soluble CD163 [ sCD163 ] ) , systemic inflammation ( soluble tumor necrosis factor receptor I [ sTNF-RI ] , interleukin 6 [ IL-6 ] , and high-sensitivity C-reactive protein [ hsCRP ] ) , and vascular inflammation ( lipoprotein-associated phospholipase A2 [ Lp-PLA2 ] ) were compared .


Multivariable linear regression was used .


A total of 200 participants were included .


Significant differences favoring EVG/c/FTC / TDF were noted for changes in sCD14 , hsCRP , and Lp-PLA2 levels .


Factors independently associated with a larger decrease in the sCD14 level included random assignment to receive EVG/c/FTC / TDF , higher baseline sCD14 level , and larger decreases in hsCRP and sCD163 levels ; factors associated with a larger Lp-PLA2 decrease included higher baseline Lp-PLA2 and IL-6 levels , smaller increases in total cholesterol and triglycerides levels , a larger decrease in the sCD14 level , and a smaller decrease in the sCD163 level .


EVG/c/FTC / TDF led to greater decreases in sCD14 , hsCRP , and Lp-PLA2 levels , compared with EFV/FTC/TDF .


Randomization group independently predicted the change in sCD14 level , and changes in monocyte activation independently predicted the change in Lp-PLA2 level .


There appears to be a more favorable effect of the integrase inhibitor EVG over efavirenz on immune activation , which may affect vascular inflammation .


Vitamin D supplementation may be an inexpensive intervention to reduce heart failure ( HF ) incidence .


However , there are insufficient data to support this hypothesis .


This study evaluates whether vitamin D plus calcium ( CaD ) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF .


Analyses were restricted to 35 983 ( of original 36 282 ) women aged 50 to 79 years old in the Women 's Health Initiative randomized trial of CaD supplementation who were randomized 1:1 in a double-blinded fashion to receive 1000 mg/d of calcium plus 400 IU/d of vitamin D3 or placebo .


Overall , 744 adjudicated incident HF cases ( intervention , 363 ; control , 381 ) occurred during a median follow-up of 7.1 ( interquartile range , 1.6 ) years .


CaD supplementation , compared with placebo , was not associated with reduced HF risk in the overall population , hazard ratio , 0.95 ; P = 0.46 .


However , CaD supplementation had differential effects ( P interaction = 0.005 ) in subgroups stratified by baseline risk status of HF defined by the presence ( high risk = 17 449 ) or absence ( low risk = 18 534 ) of pre-existing HF precursors including coronary heart diseases , diabetes mellitus , or hypertension : 37 % ( hazard ratio , 0.63 [ 95 % confidence interval , 0.46-0 .87 ] ) lower risk of HF in the low-risk versus hazard ratio , 1.06 ; P = 0.51 , in the high-risk subgroups .


CaD supplementation did not significantly reduce HF incidence in the overall cohort , however , it was beneficial among postmenopausal women without major HF precursors while of little value in high-risk subgroups .


Additional studies are warranted to confirm these findings and investigate the underlying mechanism .


http://www.clinicaltrials.gov .


Unique identifier : NCT00000611 .


Nonpegylated liposomal doxorubicin liposomal doxorubicin , ( Myocet ; Sopherion Therapeutics , Inc Canada , and Cephalon , Europe ) ( NPLD ; Myocet ( ) ) in combination with trastuzumabHerceptin ( ) ( Hoffmann-La Roche ) has shown promising activity and cardiac safety .


We conducted a randomized phase III trial of first-line NPLD plus trastuzumab and paclitaxel ( Pharmachemie B.V. ) ( MTP ) versus trastuzumab plus paclitaxel ( TP ) in patients with human epidermal growth factor 2 receptor ( HER2 ) - positive metastatic breast cancer .


Patients were randomly assigned to NPLD ( M , 50 mg/m ( 2 ) every 3 weeks for six cycles ) , trastuzumab ( T , 4 mg/kg loading dose followed by 2 mg/kg weekly ) , and paclitaxel ( P , 80 mg/m ( 2 ) weekly ) or T + P at the same doses until progression or toxicity .


The primary efficacy outcome was progression-free survival ( PFS ) .


One hundred and eighty-one patients were allocated to receive MTP , and 183 to TP .


Median PFS was 16.1 and 14.5 months with MTP and TP , respectively [ hazard ratio ( HR ) 0.84 ; two-sided P = 0.174 ] .


In patients with estrogen receptor ( ER ) - and progesterone receptor ( PR ) - negative tumors , PFS was 20.7 and 14.0 months , respectively [ HR 0.68 ; 95 % confidence interval ( CI ) 0.47-0 .99 ] .


Median overall survival ( OS ) was 33.6 and 28.9 months with MTP and TP , respectively ( HR 0.79 ; two-sided P = 0.083 ) .


In ER - and PR-negative tumors , OS was 38.2 and 27.9 months , respectively ( HR 0.63 ; 95 % CI 0.42-0 .93 ) .


The frequency of adverse events was higher with MTP , but there was no significant difference in cardiac toxicity between treatment arms .


The trial failed to demonstrate a significant clinical improvement with the addition of M to TP regimen .


The clinical benefit observed in an exploratory analysis in the ER - and PR-negative population deserves consideration for further clinical trials .


NCT00294996 .


To evaluate the efficacy of reflex entropy ( RE ) / state entropy ( SE ) in monitoring the response to nociceptive stimulus during propofol-remifentanil infusion .


After the approval of the hospital ethics committee , sixty American Society of Anesthesiologists ( ASA ) classification 1-2 patients , aged 18-65 years , receiving the hypogastrium operation undergoing general anesthesia , were randomly allocated to groups A and B with different remifentanil concentrations .


After the concentration of propofol and remifentanil reached balance , tetanic stimulation , intubation , and incision were performed respectively with certain intervals .


RE and SE were monitored during this procedure .


Twelve patients were withdrawn from this study due to the use of vasoactive drugs .


Finally , there were 28 cases in group A and 20 cases in group B.


The RE and SE were not significantly changed before and after the tetanic stimulation in both groups ( all P > 0.05 ) .


Both RE and SE were significantly increased after intubation in group B ( both P < 0.05 ) and after skin incision in both groups ( all P < 0.05 ) .


Under the same stimulation , RE and SE showed no significant difference among groups administered with different levels of remifentanil ( P > 0.05 ) .


Under the anesthesia with propofol + remifentanil , nociceptive response may cause the increase of RE and SE .


Therefore , RE and SE may be useful parameters for monitoring the nociceptive response during general anaesthesia .


To compare the outcome of deep sclerectomy ( DS ) with and without mitomycin-C ( MMC ) in patients with normal-tension glaucoma ( NTG ) .


We prospectively analysed the results of 37 eyes of 37 consecutive patients with NTG ( age ; mean SD ; 64 7 years ) who underwent DS with a collagen implant .


Patients were randomized to the MMC and non-MMC groups .


Subconjunctival MMC ( 0.4 mg/ml for 3 min ) was used intraoperatively in 15 of 37 eyes .


We defined total success as 25 % reduction in intraocular pressure ( IOP ) without medication .


Follow-up time was 12 months .


The mean preoperative IOP was significantly reduced from 15.2 2.8 mmHg to 9.3 2.7 ( p < 0.001 ) in the MMC group after 12-month follow-up and from 15.1 2.9 mmHg to 11.8 2.0 ( p < 0.001 ) in the non-MMC group .


At 12 months , the mean IOP was significantly lower in the MMC group ( p = 0.003 ) compared with the non-MMC group .


Total success was achieved in 10 of 15 eyes ( 67 % ) in MMC group and in nine of 22 eyes ( 41 % ) in non-MMC group ( p = 0.12 ) .