This prospective , randomized study compares the efficacy of fascia iliaca compartment block ( FICB ) to intravenous ( IV ) fentanyl for positioning hip fracture patients for SA .


Forty-one patients scheduled for hip fracture surgery were randomized to receive a bolus dose of IV fentanyl ( IVFE ) 1.5 g/kg ( IVFE group ) or an FICB using 40 mL ropivacaine 0.5 % ( FICB group ) 5 or 20 minutes before positioning for SA , respectively .


Numeric rating pain scale scores before and following the analgesic intervention , time needed and quality of patient position for SA performance , postoperative analgesia in terms of time to first IV morphine dose demand and morphine consumption during the first 24 hours , and patient satisfaction were documented .


Compared with the IVFE group , the FICB group showed significantly lower numeric rating pain scale scores in all instances following the analgesic intervention ( P < 0.001 ) , shorter spinal performance time ( P = 0.001 ) , and better quality of position ( P = 0.001 ) .


Postoperative morphine consumption was lower ( P = 0.026 ) , the time to first dose demand was longer ( P = 0.001 ) , and patient satisfaction rates were higher ( P < 0.001 ) in the FICB group .


Performing an FICB before positioning for SA provides superior pain management compared with IVFE administration , facilitates spinal performance , and yields satisfactory postoperative analgesia and wide patient acceptance , hence improving overall quality and efficiency of care .


To determine the psychometric properties of an observational scale of anxiety .


A cross-sectional and longitudinal survey with stroke survivor-carer dyads .


Eighty-nine dyads recruited in community stroke groups completed : a demographic questionnaire ; the Behavioural Outcomes of Anxiety scale ( BOA ) , survivor-rated ( survivor BOA ) and carer-rated ( carer BOA ) versions ; the anxiety scale of the Hospital Anxiety and Depression Scales ( HADS-A ) , also in carer and survivor versions .


Twenty-seven survivors and carers repeated the BOA after 1 week .


Correlations between the carer BOA and the survivor HADS-A ( r = .55 , p < .001 ) and the survivor BOA ( r = .73 , p < .001 ) demonstrated construct validity .


Cronbach 's alpha for the carer BOA was .81 ; item statistics did not identify any items for exclusion .


The test-retest coefficient at 1 week was 0.83 .


Receiver operating characteristic analysis against the survivor HADS-A and BOA produced areas under the curve of 0.75 and 0.88 , respectively .


At a cut-off score of 13/14 sensitivity and specificity against the HADS-A were 0.77 and 0.58 , respectively , and 0.86 and 0.68 against the survivor BOA .


The impact of stroke on memory was associated with elevated anxiety .


Scores for both BOA versions were independent of demographic variables .


The carer BOA has acceptable psychometric properties and is independent of survivor demographic variables such as age .


It identifies self-reported cases with acceptable sensitivity and specificity .


It has potential for use with persons unable to self-report anxiety .


Further validation is recommended , but its continuing use is supported .


Ginseng root and its derivatives remain atop the most widely used medicinal herbs in cardiovascular disease , despite inadequate substantiation of efficacy .


We previously reported the potential of Korean red ginseng ( KRG ) to affect vascular tone by decreasing arterial wave reflection via an unknown mechanism .


Given the preclinical link between ginseng intake and vasoactivity related to nitric oxide ( NO ) production , we sought to directly evaluate the effects of KRG root and its major root components , on an established noninvasive measure of endothelial function .


In an acute , randomized , placebo-controlled , double-blind , crossover design , 16 healthy participants ( 9M :7 F , age :309 y , BMI : 24 kg3kg/m ( 2 ) , systolicBP/diastolicBP : 10911/668mmHg ) on four occasions were administered : KRG root ( 3g ) , KRG ginsenosides extract , KRG polysaccharides extract , and cornstarch control .


Extracted fractions were delivered at doses bioequivalent to those found in 3g of KRG .


Flow-mediated vasodilatation ( FMD ) assessment , preceding a brachial blood pressure measurement , was performed at baseline and at 90 and 180 min posttreatment to assess endothelial function .


KRG significantly improved FMD posttreatment .


Maximal vasodilatation of 2.572.8 % occurred at 180min compared with control ( -0.832.7 % , P = 0.003 for all comparisons ) .


The ginsenoside extract produced a comparable response ( 1.752.6 % ) , but not the polysaccharide fraction ( 0.102.7 % ) .


Brachial blood pressure remained unchanged for all treatments ( P = 0.45 ) .


KRG acutely improved endothelial function in healthy individuals , which appears to be attributable to its ginsenoside containing fraction .


Our data confirm preclinical data and support the potential for these compounds as targets for therapeutic strategies in disorders involving endothelial dysfunction .


The Micropuncture 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture .


This was a single-center , multiple-user trial .


Four hundred and two patients undergoing possible or definite percutaneous coronary intervention ( PCI ) were randomized 1:1 to an 18-gauge versus a 21-gauge needle .


Patients and personnel pulling the sheaths and performing the follow-up were blinded .


The primary end point was a composite of access bleeding .


Events were tabulated following sheath removal , 24 h after the procedure and at the follow-up ( at 1-2 weeks ) .


End points were blindly adjudicated .


The event rate overall was 12.4 % and did not differ significantly between groups , although the 21-gauge needle was found to reduce events by more than one third .


An exploratory subgroup analysis of prespecified variables indicated that : patients who did not undergo PCI or elective procedures , female patients and those with a final sheath size of 6 Fr all had a significant or near-significant reduction of complications with Micropuncture .


Although no significant differences between the use of the 18 - and 21-gauge needles were observed , there was a 50-75 % reduction with Micropuncture in several subgroups .


The study was terminated prematurely .


Access site complications may be reduced by the use of the 21-gauge needle , particularly when the risk of bleeding is not high .


Further multicenter data will be required to confirm these hypothesis-generating observations .


No randomized comparative trials have presented long-term outcomes for laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) .


The present study was designed to compare the efficacy and safety of these two procedures .


From January 2007 to July 2008 , 64 eligible patients were randomly assigned to LSG or LRYGB .


During the 5-year follow-up , we compared morbidity rate , body mass index ( BMI ) , percent of excess weight loss ( % EWL ) , Moorehead-Ardelt ( M-A ) II quality of life , and resolution or improvement rate of obesity-related comorbidities between the groups .


Both groups were matched with respect to age , gender , and BMI .


Slightly more major complications were observed in patients undergoing LRYGB ( P > 0.05 ) .


Weight loss was significantly better with LRYGB except during the first postoperative year .


At 5 years , % EWL for LSG and LRYGB was 63.224.5 % and 76.221.7 % ( P = 0.02 ) , respectively .


No statistical difference was observed in quality of life between the groups at all intervals ( P > 0.05 ) .


At the last follow-up , most comorbidities in both groups were resolved or improved , with no difference between the groups ( P > 0.05 ) .


LRYGB and LSG are equally safe and effective in quality of life and improvement or resolution of comorbidities , and LRYGB possesses the superiority in terms of weight loss .


Further studies are needed to evaluate micronutrient deficiencies of these procedures .


To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer 's disease ( AD ) patients .


Elderly ( n = 20 ) with mild dementia ( NINCDS-ADRDA/CDR1 ) were randomly assigned to an exercise group ( EG ) on a treadmill ( 30 minutes , twice a week and moderate intensity of 60 % VOmax ) and control group ( GC ) 10 patients .


The primary outcome measure was the cognitive function using Cambridge Cognitive Examination ( CAMCOG ) .


Specifics instruments were also applied to evaluate executive function , memory , attention and concentration , cognitive flexibility , inhibitory control and functional capacity .


After 16 weeks , the EG showed improvement in cognition CAMCOG whereas the CG declined .


Compared to the CG , the EG presented significant improvement on the functional capacity .


The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables .


Walking on treadmill may be recommended as an augmentation treatment for patients with AD .


To evaluate the effects and clinical prognosis of out-patient department-based smoking cessation services for coronary heart disease ( CHD ) patients .


A total of 140 smoking patients diagnosed with coronary heart disease in our cardiovascular department were randomly divided into the intensive smoking cessation clinic follow-up group ( intervention group , patients were informed on the importance and methods to quit smoking at the first visit and reminded for that at months interval for 6 months , n = 70 ) and the conventional treatment group ( control group , n = 70 ) .


After 6 months , the smoking status , cardiovascular event rates , drug usage , out-patient medical costs and quality of life were compared between the two groups .


Age , gender , concomitant diseases , drug usage were similar between the two groups at baseline ( all P > 0.05 ) .


After 6 months , smoking quit rate [ 34.2 % ( 24/70 ) vs. 5.7 % ( 4/70 ) , P < 0.01 ] , drug use rates : lipid-lowering drugs [ 95.3 % ( 67/70 ) vs. 80.4 % ( 56/70 ) ] , blockers [ 82.4 % ( 57/70 ) vs. 41.3 % ( 28/70 ) ] , and ACEI/ARB [ 61.4 % ( 43/70 ) vs. 34.4 % ( 24/70 ) ] were significantly higher in the intervention group than in the control group , while total cardiovascular event rates [ 21.4 % ( 15/70 ) vs. 47.1 % ( 33/70 ) , P < 0.01 ] and out-patient medical costs ( 3789.3 RMB vs. 4984.2 RMB , P < 0.01 ) were significantly lower in the intervention group than in the control group .


The quality of life scores derived from MYO health survey questionnaire was significantly higher in the intervention group than in the control group ( P < 0.01 ) .


The top three reasons responsible for continuous smoking for all patients failed to quit smoking were : ( 1 ) others smoked more than me and still alive and healthy [ 90.3 % ( 56/62 ) ] ; ( 2 ) smoking helped me to keep relaxed and reduce trouble in daily work and life [ 70.9 % ( 44/62 ) ] ; ( 3 ) smoking was essential while chatting and drinking with friends [ 66.1 % ( 41/62 ) ] .


The overall satisfactory rate to this smoking cessation program was 42.8 % and the satisfactory rate was up to 50.0 % by patients .


Intensive outpatient smoking cessation follow-up program can significantly improve the smoking cessation rates , the guideline drug use rate and the quality of life while reduce medical costs for coronary heart disease patients .


We conducted a prospective , randomized trial comparing protocol to ad libitum ( ad lib ) feeding after laparoscopic pyloromyotomy .


Infants undergoing laparoscopic pyloromyotomy were randomized to protocol versus ad lib feeding strategies .


The protocol started with Pedialyte two hours post-operative .


This was repeated by another round of Pedialyte , then two rounds of half-strength formula or breast milk , followed by two rounds of full strength formula or breast milk , followed by the home feeding regimen , at which time the patient was discharged if feeding well .


The ad lib group was allowed formula or breast milk two hours after the operation and considered for discharge after tolerating three consecutive feeds .


The primary outcome variable was the length of postoperative hospitalization .


One hundred fifty infants were enrolled between January 2010 and December 2011 .


There were no differences in patient characteristics at presentation .


While the ad lib group reached goal feeds sooner than the protocol group , this did not translate into a difference in duration of postoperative hospitalization .


There were more patients with emesis in the ad lib group after goal feeding was reached , but no difference in readmissions .


Ad lib feeding allows patients to reach goal feeds more rapidly than protocol feeding following laparoscopic pyloromyotomy .


However , this goal is usually reached beyond discharge hours , resulting in a similar duration of hospitalization .


To evaluate the efficacy of dienogest + estradiol valerate ( E2V ) and gonadotrophin-releasing hormone analogue ( GnRH-a ) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis .


Multi-center , prospective , randomized study .


Three university departments of obstetrics and gynecology in Italy .


Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain .


Post-operative administration of dienogest + E2V for 9 months ( group 1 ) or GnRH-a monthly for 6 months ( group 2 ) .


A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3 , 6 and 9 months of follow up .


A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up .


The visual analogue scale score did not show any significant differences between the two groups ( p = 0.417 ) .


The questionnaire showed an increase of scores for all women compared with pre-surgery values , demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments .


No significant differences were found between the groups .


The rate of apparent endometriosis recurrence was 10.8 % in group 1 and 13.7 % in group 2 ( p = 0.962 ) .


Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first 9 months of follow-up .


The in utero environment is known to affect fetal development however many of the mechanisms by which this occurs remain unknown .


The aim of this study was to examine the association between maternal dietary macronutrient intake and lifestyle throughout pregnancy and neonatal weight and adiposity .


This was an analysis of 542 mother and infant pairs from the ROLO study ( Randomised cOntrol trial of LOw glycaemic index diet versus no dietary intervention to prevent recurrence of fetal macrosomia ) .


Food diaries as well as food frequency and lifestyle and physical activity questionnaires were completed during pregnancy .


Maternal anthropometry was measured throughout pregnancy and neonatal anthropometry was measured at birth .


Multiple linear regression analysis revealed the main maternal factor associated with increased birth weight was greater gestational weight gain R2adj 23.3 % ( F = 11.547 , p < 0.001 ) .


The main maternal factor associated with increased birth length was non-smoking status R2adj 27.8 % ( F = 6.193 , p < 0.001 ) .


Neonatal central adiposity ( determined using waist : length ratio ) was negatively associated with maternal age , and positively associated with the following parameters : smoking status , maternal pre-pregnancy arm circumference , percentage energy from saturated fat in late pregnancy , postprandial glucose at 28 weeks gestation and membership of the control group with a positive trend towards association with trimester 2 glycaemic load R2adj 38.1 % ( F = 8.000 , p < 0.001 ) .


Several maternal diet and lifestyle factors were associated with neonatal anthropometry .


Low glycaemic index dietary intervention in pregnancy was found to have a beneficial effect on neonatal central adiposity .


Additionally , central adiposity was positively associated with maternal dietary fat intake and postprandial glucose highlighting the important role of healthy diet in pregnancy in promoting normal neonatal adiposity .


Current Controlled Trials ISRCTN54392969 .


To estimate the incremental cost-effectiveness of infliximab versus conventional combination treatment over 21months in patients with methotrexate-refractory early rheumatoid arthritis .


In this multicentre , two-arm , parallel , randomised , active-controlled , open-label trial , rheumatoid arthritis patients with < 1year symptom duration were recruited from 15 rheumatology clinics in Sweden between October 2002 and December 2005 .


After 3-4months of methotrexate monotherapy , patients not achieving low disease activity were randomised to addition of infliximab or sulfasalazine + hydroxychloroquine ( conventional treatment group ) .


Costs of drugs , healthcare use , and productivity losses were retrieved from nationwide registers , while EuroQol 5-Dimensions utility was collected quarterly .


Of 487 patients initially enrolled , 128 and 130 were randomised to infliximab and conventional treatment , respectively .


The infliximab group accumulated higher drug and healthcare costs ( 27,487 vs 10,364 ; adjusted mean difference 16,956 ( 95 % CI 14,647 to 19,162 ) ) , while productivity losses did not differ ( 33,804 vs 29,220 ; 3961 ( 95 % CI -3986 to 11,850 ) ) , resulting in higher societal cost compared to the conventional group ( 61,291 vs 39,584 ; 20,916 ( 95 % CI 12,800 to 28,660 ) ) .


Mean accumulated quality-adjusted life-years ( QALYs ) did not differ ( 1.10 vs 1.12 ; adjusted mean difference favouring infliximab treatment 0.01 ( 95 % CI -0.07 to 0.08 ) ) .


The incremental cost-effectiveness ratios for the infliximab versus conventional treatment strategy were 2,404,197 / QALY from the societal perspective and 1,948,919 / QALY from the healthcare perspective .


In early , methotrexate-refractory rheumatoid arthritis , a treatment strategy commencing with addition of infliximab , as compared to sulfasalazine + hydroxychloroquine , was not cost-effective over 21months at willingness to pay levels generally considered acceptable .


NCT00764725 .


To identify growth-related collagen and bone parameters in small-for-gestational-age ( SGA ) and appropriate-for-gestational-age ( AGA ) preterm infants during the first six months post-term .


In SGA preterm infants , increased growth and decreased bone acquisition , which we demonstrated previously , may be reflected by these markers .


Observational study within a randomized controlled trial .


Thirty-three SGA ( weight , length or both at birth < -2 SDS ) and 98 AGA preterm infants ( gestational age [ median ( IQR ) ] : 311 ( 16 ) vs 303 ( 20 ) weeks ; 727 % vs 429 % boys ) .


Weight ( g ) , length ( cm ) , procollagen type I N-terminal peptide ( PINP ; g/l ) , urinary helical peptide ( UHP ; g/mmol creatinine ) and alkaline phosphatase ( ALP ; U/l ) expressed as standard deviation scores ( SDS ) at term age , three and six months post-term .


Weight and length gain during the first six months post-term and PINP SDS at term age , three months and six months post-term were higher in SGA compared with AGA infants .


UHP SDS and ALP SDS were similar in SGA and AGA infants .


PINP SDS and UHP SDS at term age and PINP SDS at three months were associated with subsequent weight and length gain until six months post-term .


Increased growth in SGA compared with AGA preterm infants is reflected by increased collagen type I synthesis during the first six months post-term , suggesting that PINP and UHP correspond with growth in preterm infants .


An explanation for decreased bone acquisition of SGA preterm infants may be that increased collagen type I synthesis is not directly followed by increased bone mineralization .


Current randomized trials have demonstrated the effects of short-term rosuvastatin therapy in preventing contrast-induced acute kidney injury ( CIAKI ) .


However , the consistency of these effects on patients administered different volumes of contrast media is unknown .


In the TRACK-D trial , 2998 patients with type 2 diabetes and concomitant chronic kidney disease ( CKD ) who underwent coronary/peripheral arterial angiography with or without percutaneous intervention were randomized to short-term ( 2 days before and 3 days after procedure ) rosuvastatin therapy or standard-of-care .


This prespecified analysis compared the effects of rosuvastatin versus standard therapy in patients exposed to ( moderate contrast volume [ MCV ] , 200-300 ml , n = 712 ) or ( high contrast volume [ HCV ] , 300 ml , n = 220 ) .


The primary outcome was the incidence of CIAKI .


The secondary outcome was a composite of death , dialysis/hemofiltration or worsened heart failure at 30 days .


Rosuvastatin treatment was associated with a significant reduction in CIAKI compared with the controls ( 2.1 % vs. 4.4 % , P = 0.050 ) in the overall cohort and in patients with MCV ( 1.7 % vs. 4.5 % , P = 0.029 ) , whereas no benefit was observed in patients with HCV ( 3.4 % vs. 3.9 % , P = 0.834 ) .


The incidence of secondary outcomes was significantly lower in the rosuvastatin group compared with control group ( 2.7 % vs. 5.3 % , P = 0.049 ) in the overall cohort , but it was similar between the patients with MCV ( 2.0 % vs. 4.2 % , P = 0.081 ) or HCV ( 5.1 % vs. 8.8 % , P = 0.273 ) .


Periprocedural short-term rosuvastatin treatment is effective in reducing CIAKI and adverse clinical events for patients with diabetes and CKD after their exposure to a moderate volume of contrast medium .


To investgate the effect of Xuebijing Injection on immune regulation in patients with systemic inflammatory response syndrome ( SIRS ) .


56 SIRS patients admitted to the ICU of Guizhou Provincial Hospital from January 2013 to December 2013 were included in this study .


The patients were randomly divided into a control ( C ) and a treatment ( T ) group .


Patients in C group received routine treatment ; while patients in T group received additional Xuebijing Injection 50 mL Bid .


The following indicators were recorded and compared between the two groups before and 4 and 7 days after treatments : CD4 + , CD8 + , CD4 + / CD8 + , monocytes CD14 + / human leukocyte antigen-DR ( HLA-DR ) , score of acute physiology and chronic health evaluation II ( APACHE II ) , heart rate , white blood cells , body temperature , respiration rate , and MODS ( 7 d after treatment only ) .


No differences were found between the two groups before treatments ( P > 0.05 ) .


T Group had higher levels of CD4 + , CD8 , CD4 + / CD8 + and monocytes CD14 + / HLA-DR than C group at 4 and 7 d after treatments ( P < 0.05 ) .


T group also had higher levels of improvement in vital indicators compared with C group ( P < 0.05 ) .


No significant difference in incidence of multiple organ dysfunction syndrome ( MODS ) was found between the two groups ( P > 0.05 ) .


Xuebijing Injection can regulate immune function of patients with SIRS .


Incisional hernias in old stoma wounds occur in one-third of former stoma patients and pose a significant clinical problem .


Parastomal hernias can be prevented by prophylactic mesh placement ; however , no trial results are available for incisional hernia prevention after stoma reversal .


In this feasibility study , we explore the safety of placing an intraperitoneal mesh to prevent incisional herniation after temporary stoma reversal .


Ten patients who underwent a low anterior resection with a deviating double-loop stoma for rectal cancer received an intraperitoneal parastomal mesh at the time of stoma formation .


At stoma reversal , laparoscopy was performed and adhesions were scored .


After reversal , the mesh defect was closed .


Mesh and stoma complications were closely monitored .


Incisional herniation was assessed at the 2-year follow-up after stoma reversal using ultrasonography .


No infections occurred after mesh placement .


After a median of 6 months , stomas were reversed .


Laparoscopy could be performed in seven patients ; all patients had adhesions ( median of 25 % of mesh surface ) .


In three patients , the bowel was involved ; one required a laparotomy for bowel mobilization during stoma reversal .


No adhesion-related morbidity was noted at any time .


Except for one superficial wound infection after stoma reversal , no infectious complications were observed .


After a median follow-up of 26 months , no incisional herniations were demonstrated .


Prophylactic mesh placement in temporary stoma formations seems safe and feasible and prevents incisional herniation 2 years after stoma reversal .


We aimed to compare panitumumab , a fully human monoclonal antibody against EGFR , plus radiotherapy with chemoradiotherapy in patients with unresected , locally advanced squamous-cell carcinoma of the head and neck .


In this international , open-label , randomised , controlled , phase 2 trial , we recruited patients with locally advanced squamous-cell carcinoma of the head and neck from 22 sites in eight countries worldwide .


Patients aged 18 years and older with stage III , IVa , or IVb , previously untreated , measurable ( 10 mm for at least one dimension ) , locally advanced squamous-cell carcinoma of the head and neck ( non-nasopharygeal ) and an Eastern Cooperative Oncology Group performance status of 0-1 were randomly assigned ( 2:3 ) by an independent vendor to open-label chemoradiotherapy ( two cycles of cisplatin 100 mg/m ( 2 ) during radiotherapy ) or to radiotherapy plus panitumumab ( three cycles of panitumumab 9 mg/kg every 3 weeks administered with radiotherapy ) using a stratified randomisation with a block size of five .


All patients received 70-72 Gy to gross tumour and 54 Gy to areas of subclinical disease with accelerated fractionation radiotherapy .


The primary endpoint was local-regional control at 2 years , analysed in all randomly assigned patients who received at least one dose of their assigned protocol-specific treatment ( chemotherapy , radiation , or panitumumab ) .


The trial is closed and this is the final analysis .


This study is registered with ClinicalTrials.gov , number NCT00547157 .


Between Nov 30 , 2007 , and Nov 16 , 2009 , 152 patients were enrolled , and 151 received treatment ( 61 in the chemoradiotherapy group and 90 in the radiotherapy plus panitumumab group ) .


Local-regional control at 2 years was 61 % ( 95 % CI 47-72 ) in the chemoradiotherapy group and 51 % ( 40-62 ) in the radiotherapy plus panitumumab group .


The most frequent grade 3-4 adverse events were mucosal inflammation ( 25 [ 40 % ] of 62 patients in the chemoradiotherapy group vs 37 [ 42 % ] of 89 patients in the radiotherapy plus panitumumab group ) , dysphagia ( 20 [ 32 % ] vs 36 [ 40 % ] ) , and radiation skin injury ( seven [ 11 % ] vs 21 [ 24 % ] ) .


Serious adverse events were reported in 25 ( 40 % ) of 62 patients in the chemoradiotherapy group and in 30 ( 34 % ) of 89 patients in the radiotherapy plus panitumumab group .


Panitumumab can not replace cisplatin in the combined treatment with radiotherapy for unresected stage III-IVb squamous-cell carcinoma of the head and neck , and the role of EGFR inhibition in locally advanced squamous-cell carcinoma of the head and neck needs to be reassessed .


Amgen .


High-intensity focused ultrasound ( HIFU ) is a noninvasive alternative to traditional invasive body sculpting procedures .


To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques , grid repeat ( GR ) and site repeat ( SR ) .


Two multicenter studies were conducted .


Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols ( total fluence , 150-180 J/cm ) .


Primary end point was change from baseline in waist circumference ( CBWC ) at 12 weeks .


Secondary end points included CBWC at 4 and 8 weeks and investigator - and subject-assessed clinical improvement .


Adverse events were monitored throughout the study .


In the intent-to-treat ( ITT ) population , all subjects had a statistically significant mean circumferential reduction of -2.3 2.9 cm ( p < .0001 ) from baseline at 12 weeks , with no significant differences among the 5 treatment groups ( ITT : p = .153 ) .


Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects ( -1.1 1.9 cm , p < .0001 ) .


Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects .


High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction , resulting in statistically significant CBWC in all treatment groups .


Postoperative readmissions have been proposed by Medicare as a quality metric and can impact provider reimbursement .


Because readmission after pancreatectomy is common , we sought to identify factors associated with readmission to establish a predictive risk scoring system .


A retrospective analysis of 2,360 pancreatectomies performed at 9 high-volume pancreatic centers between 2005 and 2011 was performed .


Forty-five factors strongly associated with readmission were identified .


To derive and validate a risk scoring system , the population was randomly divided into 2 cohorts in a 4:1 fashion .


A multivariable logistic regression model was constructed and scores were assigned based on the relative odds ratio ( OR ) of each independent predictor .


A composite Readmission after Pancreatectomy ( RAP ) score was generated and then stratified to create risk groups .


Overall , 464 ( 19.7 % ) patients were readmitted within 90 days .


Eight pre - and postoperative factors , including earlier MI ( OR = 2.03 ) , American Society of Anesthesiologists class 3 ( OR = 1.34 ) , dementia ( OR = 6.22 ) , hemorrhage ( OR = 1.81 ) , delayed gastric emptying ( OR = 1.78 ) , surgical site infection ( OR = 3.31 ) , sepsis ( OR = 3.10 ) , and short length of stay ( OR = 1.51 ) were independently predictive of readmission .


The 32-point RAP score generated from the derivation cohort was highly predictive of readmission in the validation cohort ( area under the receiver operating curve = 0.72 ) .


The low-risk ( 0 to 3 ) , intermediate-risk ( 4 to 7 ) , and high-risk ( > 7 ) groups correlated with 11.7 % , 17.5 % , and 45.4 % observed readmission rates , respectively ( p < 0.001 ) .


The RAP score is a novel and clinically useful risk scoring system for readmission after pancreatectomy .


Identification of patients with increased risk of readmission using the RAP score will allow efficient resource allocation aimed to attenuate readmission rates .


It also has potential to serve as a new metric for comparative research and quality assessment .


To compare the induction of remission and cost-effectiveness of enteral nutrition ( EN ) and infliximab ( IFX ) in moderate-to-severe active Crohn 's disease ( CD ) .


Moderate-to-severe active CD patients were divided into IFX group and EN group .


Remission rate , time to remission and treatment cost were compared between the two groups .


Clinical remission was defined as Crohn 's disease activity index ( CDAI ) < 150 .


The quality of life was evaluated by inflammatory bowel disease questionnaire of quality of life ( IBDQ ) .


A total of 100 patients were analyzed , including 48 patients in IFX group and 52 patients in EN group .


IFX group had higher remission rate [ 87.5 % ( 42/48 ) vs 67.3 % ( 35/52 ) , P = 0.017 ] and shorter time to remission [ ( 11.00 8.35 ) days vs ( 33.94 14.60 ) days , P < 0.001 ] than EN group .


Treatment costs before remission were similar in two groups ( P = 0.351 ) .


The increase of IBDQ scores before and after treatment in IFX group was much higher than that of EN group ( 42.74 27.50 vs 7.57 22.77 , P < 0.001 ) .


Similarly , patients in EN group had greater increase of body mass index ( BMI ) than that of IFX group [ ( 1.32 0.29 ) kg/m ( 2 ) vs ( 0.51 0.07 ) kg/m ( 2 ) , P < 0.001 ] .


For patients with CDAI < 280 , remission rate was not significantly different [ 85.7 % ( 24/28 ) vs 81.8 % ( 18/22 ) , P = 0.718 ] between the two groups , while treatment cost in EN group was less than that of IFX group [ ( 16.1 5.9 ) 10 ( 3 ) RMB vs ( 22.9 11.9 ) 10 ( 3 ) RMB , P = 0.021 ] .


For patients with severe CD ( CDAI 280 ) , IFX has higher remission rate , shorter time to remission and comparable treatment cost than EN .


But for patients with CDAI < 280 , EN group has comparable remission rate to IFX group with lower cost .


Testicular germ cell cancer ( GCC ) patients treated with cisplatin-etoposide-bleomycin chemotherapy ( BEP ) have excellent prognosis but have an increased risk of late-occurring morbidities , which may be associated with changes in the inflammatory profile .


The objective of the study was to explore plasma cytokine concentrations in GCC patients randomized to resistance training or usual care during BEP , in comparison with healthy controls .


This was a randomized controlled trial in GCC patients enrolled from an oncology clinic , including a healthy reference group for comparison purposes .


Plasma granulocyte macrophage colony-stimulating factor , interferon - , IL-1 , IL-2 , IL-6 , IL-8 , IL-10 , IL-12 , and TNF - were measured in fasting blood samples from GCC patients randomized to resistance training ( INT ; n = 15 ) or usual care ( CON ; n = 15 ) and healthy age-matched controls ( REF ; n = 19 ) .


Clinical toxicity assessments and patient-reported end points were also recorded .


CON and INT were balanced at baseline .


Compared with REF , CON had higher concentrations of IL-10 , IL-6 , and interferon - , and INT had higher concentrations of IL-6 , IL-8 and TNF - ( all P < .05 ) .


At the end of therapy , concentrations of IL-6 , IL-8 , and IL-10 increased in both GCC groups ( all P < .01 ) .


Three months after therapy , all cytokine concentrations were comparable with the pretreatment levels in both GCC-groups but remained elevated compared with REF ( P < .05 ) .


Changes in TNF - correlated with pulmonary toxicity ( P < .01 ) .


At the end of therapy , IL-6 concentrations correlated with quality of life ( P < .05 ) and fatigue ( P < .01 ) .


GCC patients treated with BEP display consistently elevated levels of systemic inflammatory markers compared with healthy controls .


Resistance training during therapy has no impact on plasma cytokine concentrations .


This work tested the hypothesis that patients with high negative affectivity ( NA ) would have a better response to a serotonergic agent ( escitalopram ) than to one not thought to act directly on serotonin ( bupropion ) .


Data from a study conducted between August 2007 and July 2011 were reanalyzed retrospectively .


Patients ( N = 245 ) meeting criteria for major depressive disorder ( MDD ) , diagnosed with DSM-IV-TR , were randomly assigned to double-blind treatment with bupropion extended-release , escitalopram , or the combination .


Negative affectivity score was estimated using the guilt , hostility/irritability , and fear/anxiety items of the Hamilton Depression Rating Scale , the Montgomery-Asberg Depression Rating Scale , the Quick Inventory of Depressive Symptoms , and the Social Adjustment Scale .


We felt that these items captured published descriptions of the NA construct .


A Clinical Global Impressions-Severity of Illness ( CGI-S ) score 2 defined response .


Because combined treatment addressed both serotonin and non-serotonin systems , patients treated with both medications did not test the hypothesis and so were excluded from the analyses .


Analysis of covariance with treatment as a grouping variable , NA as covariate , and CGI-S as dependent variable showed a significant 2-way interaction between treatment and NA ( F , = 4.82 , P < .03 ) .


In the low-NA group , response rates were similar between treatments ( escitalopram : 28/42 [ 67 % ] ; bupropion : 23/40 [ 58 % ] ; NS ) , while there was a significant advantage for escitalopram in patients with high NA ( escitalopram : 24/40 [ 60 % ] ; bupropion = 14/41 [ 34 % ] ; P = .017 ) .


These data suggest that patients with high negative affectivity respond preferentially to antidepressants that selectively enhance serotonin neurotransmission .


Although patients with low NA appear to benefit from serotonin enhancement as well , they also improved with bupropion , an antidepressant not thought to directly affect serotonin neurotransmission .


These findings come from retrospective analyses using unproven approximation of NA , so no clinical inferences should be made before independent replication utilizing accepted NA measurement .


ClinicalTrials.gov identifier : NCT00519428 .


There is no consensus on the efficacy of postoperative infusion of local anesthetics after radical mastectomy .


A randomized , double-blind , placebo-controlled , parallel-groups clinical trial was conducted in a tertiary hospital .


Eighty consecutive women with operable breast cancer with indications for modified radical mastectomy without breast reconstruction were assigned randomly to receive infusion of levobupivacaine ( 0.5 % ) or saline at 2 ml/hour for 48 hours through a wound catheter .


Seventy-three women finished the study ( intervention group , n = 34 ; control group , n = 39 ) .


During surgery , all patients received 0.25 % levobupivacaine ( 30 ml ) .


The levobupivacaine group reported less pain ( p < 0.001 ) than controls in the postanesthesia care unit ( 1.6 1.3 versus 6.7 1.8 ) and on the ward at 24 ( 0.8 0.9 versus 4.2 1.9 ) and 48 ( 0.4 0.7 versus 3.3 2.3 ) hours .


In the postanesthesia care unit , the levobupivacaine group consumed less metamizole ( 0.4 0.5 versus 0.8 0.4 ; p < 0.001 ) and dexketoprofen ( 0.1 0.3 versus 0.7 0.4 ; p < 0.001 ) , with differences in paracetamol use being insignificant ( 0.8 0.4 versus 0.9 0.3 ; p = 0.140 ) .


On the ward , the levobupivacaine group used significantly less paracetamol ( 0.5 0.7 versus 2.0 2.0 ; p < 0.001 ) and metamizole ( 0.2 0.4 versus 1.2 1.4 ; p < 0.001 ) , but differences in dexketoprofen were not significant ( 0.03 0.2 versus 0.2 0.6 ; p = 0.074 ) .


In the postanesthesia care unit , the levobupivacaine and control groups consumed 0 0 and 0.7 1.2 doses of opioids ( p = 0.001 ) , respectively .


The authors observed no differences in nausea and vomiting at any stage in the postanesthesia care unit ( 0.2 0.4 versus 0.4 0.5 ; p = 0.081 ) or on the ward ( 0.3 0.5 versus 0.4 0.5 ; p = 0.563 ) .


All participants reported high levels of satisfaction .


Continuous infusion of local anesthetic reduces pain and analgesic consumption , with high satisfaction , but does not affect rates of nausea and vomiting .


The Interventional Management of Stroke ( IMS ) III study tested the effect of intravenous tissue-type plasminogen activator ( tPA ) alone when compared with intravenous tPA followed by endovascular therapy and collected cost data to assess the economic implications of the 2 therapies .


This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the United States .


Prospective cost analysis of the US subjects was treated with intravenous tPA alone or with intravenous tPA followed by endovascular therapy in the IMS III trial .


Results were compared with expected Medicare payments .


The adjusted cost of a stroke admission in the study was $ 35 130 for subjects treated with endovascular therapy after intravenous tPA treatment and $ 25 630 for subjects treated with intravenous tPA alone ( P < 0.0001 ) .


Significant factors related to costs included treatment group , baseline National Institutes of Health Stroke Scale , time from stroke onset to intravenous tPA , age , stroke location , and comorbid diabetes mellitus .


The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $ 46 444 when compared with $ 30 350 for those who did not have general anesthesia .


The costs of embolectomy for IMS III subjects and patients from the National Inpatient Sample cohort exceeded the Medicare diagnosis-related group payment in 75 % of patients .


Minimizing the time to start of intravenous tPA and decreasing the use of routine general anesthesia may improve the cost-effectiveness of medical and endovascular therapy for acute stroke .


http://www.clinicaltrials.gov .


Unique identifier : NCT00359424 .


Dietary linoleic acid ( LA , 18:2 n-6 ) lowering in rats reduces n-6 polyunsaturated fatty acid ( PUFA ) plasma concentrations and increases n-3 PUFA ( eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) ) concentrations .


To evaluate the extent to which 12 weeks of dietary n-6 PUFA lowering , with or without increased dietary n-3 PUFAs , alters unesterified and esterified plasma n-6 and n-3 PUFA concentrations in subjects with chronic headache .


Secondary analysis of a randomized trial .


Subjects with chronic headache were randomized for 12 weeks to ( 1 ) average n-3 , low n-6 ( L6 ) diet ; or ( 2 ) high n-3 , low n-6 LA ( H3-L6 ) diet .


Esterified and unesterified plasma fatty acids were quantified at baseline ( 0 weeks ) and after 12 weeks on a diet .


Compared to baseline , the L6 diet reduced esterified plasma LA and increased esterified n-3 PUFA concentrations ( nmol/ml ) , but did not significantly change plasma arachidonic acid ( AA , 20:4 n-6 ) concentration .


In addition , unesterified EPA concentration was increased significantly among unesterified fatty acids .


The H3-L6 diet decreased esterified LA and AA concentrations , and produced more marked increases in esterified and unesterified n-3 PUFA concentrations .


Dietary n-6 PUFA lowering for 12 weeks significantly reduces LA and increases n-3 PUFA concentrations in plasma , without altering plasma AA concentration .


A concurrent increase in dietary n-3 PUFAs for 12 weeks further increases n-3 PUFA plasma concentrations and reduces AA .


Cognitive behaviour therapy ( CBT ) has been found to reduce the impact of menopausal symptoms , hot flushes and night sweats .


This study investigates the moderators and mediators of CBT for women who had problematic menopausal symptoms following breast cancer treatment .


Analysis of 96 patients with breast cancer induced menopausal symptoms recruited to the MENOS1 trial ; 47 were randomly assigned to Group CBT and 49 to usual care .


Questionnaires were completed at baseline , 9 and 26 weeks post randomisation .


Potential moderators and mediators , including sociodemographic , clinical and psychological factors , of the treatment effect on the primary outcome were examined .


Hot Flush Problem Rating .


CBT was effective at reducing problem rating at 9 weeks regardless of age , BMI , time since breast cancer diagnosis , menopausal status at time of diagnosis , or type of cancer treatment ( radiotherapy or chemotherapy or endocrine treatment ) .


The treatment effect was significantly greater in women not receiving chemotherapy , those with higher levels of psychological distress at baseline and for non-white women .


Beliefs about control/coping with hot flushes were the main mediators of improvement in problem rating following CBT .


Beliefs about hot flushes in a social context , depressed mood and sleep problems were also identified as mediators .


These findings suggest that CBT is widely applicable for breast cancer patients who are experiencing treatment related menopausal symptoms , and that CBT works mainly by changing beliefs and improving mood and sleep .


Opioid-induced androgen deficiency ( OPIAD ) affects patients treated with opioid analgesics .


The norepinephrine reuptake inhibitor ( NRI ) and - opioid receptor ( MOR ) agonist activities of tapentadol may result in tapentadol having less effect on serum androgen concentrations than analgesics acting through the MOR alone , such as morphine and oxycodone .


The objectives of this publication are to 1 ) evaluate the effects of tapentadol ( NUCYNTA and NUCYNTA extended release [ ER ] ) on sex hormone concentrations in healthy male volunteers ( vs placebo and morphine ) and patients with osteoarthritis ( vs placebo and oxycodone ) , and 2 ) present a mechanistic hypothesis explaining how the combined MOR agonist and NRI activities of tapentadol may result in less impact on androgen concentrations .


Three clinical studies were conducted : study 1 ( single-dose comparison study vs morphine in healthy volunteers ) , study 2 ( single-dose-escalation study in healthy volunteers without an active comparator ) , and study 3 ( multiple-dose study vs oxycodone in patients with osteoarthritis ) .


Studies 1 and 2 were conducted at medical research centers in Germany and the United Kingdom ; study 3 was conducted at primary and secondary care centers and medical research centers in the United States .


All three studies were randomized , double blind , and placebo controlled .


Concentrations of testosterone , luteinizing hormone ( LH ) , and follicle-stimulating hormone ( FSH ; study 3 only ) were evaluated at 6 and 24 hours postdose in studies 1 and 2 , respectively , and at varying time points postdose in study 3 .


In study 1 , mean serum total testosterone concentrations in healthy male volunteers were similar at baseline for all treatment periods ; 6 hours after dosing , mean concentrations were comparable between placebo ( 8.6 nmol/L ) and tapentadol immediate release ( IR ; 43 mg , 8.8 nmol/L ; 86 mg , 9.3 nmol/L ) , but were lower following administration of morphine IR 30 mg ( 5.4 nmol/L ) .


In study 2 , there were no or minimal changes in testosterone in the therapeutic dose range with tapentadol IR ( 75-100 mg ) , and there was a modest decrease that appeared to level off in the supratherapeutic range ( 125-175 mg ) ; mean testosterone and LH concentrations with all doses remained within normal ranges ( testosterone , 4.56-28 .2 nmol/L ; LH , 2.9-4 .6 U/L ) .


In study 3 , the decrease in the mean [ standard deviation ] testosterone concentration from baseline to endpoint for male patients receiving tapentadol ER ( 100 mg , -1.9 [ 0.71 ] nmol/L ; 200 mg , -2.1 [ 0.93 ] nmol/L ) was numerically smaller compared to oxycodone CR ( 20 mg , -2.7 [ 0.93 ] nmol/L ) , but higher compared to placebo ( -0.3 [ 1.62 ] nmol/L ) .


These results suggest that tapentadol , which has combined MOR and NRI activities , may have a lower impact on sex hormone concentrations than pure opioid analgesics , such as morphine or oxycodone .


The data and mechanistic rationale presented herein provide a justification for conducting additional hypothesis testing studies , and are not intended to be used as a basis for clinical decision making .


Future studies may help elucidate whether the observed trends are clinically significant and would translate into a reduced incidence of OPIAD .


Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder ( MDD ) based on the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision .


This phase 4 , multicenter , parallel-group , randomized , double-blind , placebo-controlled study was conducted from June 30 , 2010 , to June 8 , 2011 .


Patients received placebo or desvenlafaxine 50 mg/d ( 1:1 ratio ; n = 217 in each group ) .


The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale ( HDRS17 ) total score .


Secondary outcome measures included change in the Sheehan Disability Scale ( SDS ) , the Clinical Global Impressions-Improvement scale ( CGI-I ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Visual Analog Scale-Pain Intensity ( VAS-PI ) .


At end point , compared to placebo , desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores ( last-observation-carried-forward analysis ; adjusted mean change from baseline -9.9 vs -8.1 , respectively ; P = .004 ) and significant improvements on the CGI-I ( P < .001 ) , MADRS ( P = .002 ) , SDS ( P = .038 ) , and VAS-PI ( P < .001 ) .


Improvements on the SDS and VAS-PI reached significance by week 2 .


Desvenlafaxine was generally safe and well tolerated .


Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women , with significant benefits on pain and functional outcomes evident as early as week 2 .


The safety and tolerability of desvenlafaxine were consistent with data in other populations .


ClinicalTrials.gov identifier : NCT01121484 .


Anemia is associated with poor tumor control .


It was previously observed that accelerated radiotherapy combined with carbogen breathing and nicotinamide ( ARCON ) can correct this adverse outcome in patients with head and neck cancer .


The purpose of this study was to validate this observation based on data from a randomized trial .


Of 345 patients with cT2-4 laryngeal cancer , 174 were randomly assigned to accelerated radiotherapy and 171 to ARCON .


Hemoglobin levels , measured before treatment , were defined as low when < 7.5 mmol/L for women and < 8.5 mmol/L for men .


The hypoxia marker pimonidazole was used to assess the oxygenation status in tumor biopsies .


Data were analyzed 2 years after inclusion of the last patient .


Pretreatment hemoglobin levels were available and below normal in 27 of 173 ( 16 % ) accelerated radiotherapy and 27 of 167 ( 16 % ) ARCON patients .


In patients with normal pretreatment , hemoglobin levels treatment with ARCON had no significant effect on 5-year loco-regional control ( LRC , 79 % versus 75 % ; P = 0.44 ) and disease-free survival ( DFS , 75 % vs. 70 % ; P = 0.46 ) compared with accelerated radiotherapy .


However , in patients with low pretreatment , hemoglobin levels ARCON significantly improved 5-year LRC ( 79 % vs. 53 % ; P = 0.03 ) and DFS ( 68 % vs. 45 % ; P = 0.04 ) .


In multivariate analysis including other prognostic factors , pretreatment hemoglobin remained prognostic for LRC and DFS in the accelerated radiotherapy treatment arm .


No correlation between pretreatment hemoglobin levels and pimonidazole uptake was observed .


Results from the randomized phase III trial support previous observations that ARCON has the potential to correct the poor outcome of cancer patients with anemia ( ClinicalTrials.gov number , NCT00147732 ) .


To investigate the effect of different heat-stimulating time lengths on lower back pain .


Forty participants were randomly assigned to four groups of various heating time lengths .


The short heating time length group ( SL ) , moderate heating time length group ( ML ) , and long heating time length group ( LL ) respectively received 15 , 30 , and 60 min of moxibustion therapy stimulating the acupoint Guanyuan ( CV 4 ) .


The conventional acupuncture group ( CA ) received needle acupuncture treatment as a control group .


The participants were treated continuously over a 2-week treatment period for a total of 10 sessions , with five sessions given per week .


Participants were assessed weekly by blinded assessors , using the visual analogue scale ( VAS ) and Roland Morris Questionnaire ( RMQ ) .


The VAS and RMQ scores reduced in all four groups during treatment .


There were significant differences in VAS scores ( P < 0.01 ) and RMQ scores ( P < 0.01 ) between before treatment and after 2 weeks of treatment in the LL group .


After treatment , the LL group reported significantly lower VAS scores compared with the CA group , ML group , and SL group ( P < 0.05 ) .


The long and moderate lengths of heat-stimulating time of 30 and 60 min may be more effective for relieving lower back pain than that of short stimulating time lengths .


In a recent phase II study of onartuzumab ( MetMAb ) , patients whose non-small cell lung cancer ( NSCLC ) tissue scored as positive for MET protein by immunohistochemistry ( IHC ) experienced a significant benefit with onartuzumab plus erlotinib ( O+E ) versus erlotinib .


We describe development and validation of a standardized MET IHC assay and , retrospectively , evaluate multiple biomarkers as predictors of patient benefit .


Biomarkers related to MET and/or EGF receptor ( EGFR ) signaling were measured by IHC , FISH , quantitative reverse transcription PCR , mutation detection techniques , and ELISA .


A positive correlation between IHC , Western blotting , and MET mRNA expression was observed in NSCLC cell lines/tissues .


An IHC scoring system of MET expression taking proportional and intensity-based thresholds into consideration was applied in an analysis of the phase II study and resulted in the best differentiation of outcomes .


Further analyses revealed a nonsignificant overall survival ( OS ) improvement with O+E in patients with high MET copy number ( mean5 copies/cell by FISH ) ; however , benefit was maintained in `` MET IHC-positive '' / MET FISH-negative patients ( HR , 0.37 ; P = 0.01 ) .


MET , EGFR , amphiregulin , epiregulin , or HGF mRNA expression did not predict a significant benefit with onartuzumab ; a nonsignificant OS improvement was observed in patients with high tumor MET mRNA levels ( HR , 0.59 ; P = 0.23 ) .


Patients with low baseline plasma hepatocyte growth factor ( HGF ) exhibited an HR for OS of 0.519 ( P = 0.09 ) in favor of onartuzumab treatment .


MET IHC remains the most robust predictor of OS and progression-free survival benefit from O+E relative to all examined exploratory markers .


Energy deficit ( ED ) diminishes fat-free mass ( FFM ) with concomitant reductions in anabolic hormone secretion .


A modest increase in protein to recommended dietary allowance ( RDA ) levels during ED minimally attenuates decrements in insulin-like growth factor-I ( IGF-I ) .


The impact of dietary protein above the RDA on circulating anabolic hormones and their relationships with FFM in response to ED are not well described .


Thirty-three adults were assigned diets providing protein at 0.8 ( RDA ) , 1.6 ( 2-RDA ) , and 2.4 ( 3-RDA ) g/kg/d for 31days .


Testosterone , sex-hormone binding globulin ( SHBG ) and IGF-I system components were assessed after a 10-day period of weight-maintenance ( WM ) and after a 21-day period of ED ( 40 % ) achieved by an increase in energy expenditure and decreased energy intake .


Associations between the change in FFM and anabolic hormone levels were determined .


As compared to WM and regardless of dietary protein intake , total and free testosterone , total IGF-I , and acid-labile subunit decreased ( P < 0.05 ) , whereas SHBG and IGF binding proteins-1 , -2 , and -3 increased ( P < 0.05 ) during ED .


There were no energy-by-protein interactions on any hormones or IGF-I system components measured .


Changes in FFM in response to ED were negatively associated with acid-labile subunit ( ALS ) ( r = -0.62 , P < 0.05 ) in 2-RDA ; however , no other relationships were observed .


Consuming a high protein diet does not impact the androgenic and IGF-I system response to ED .


These data suggest that the protective effects of high protein diets on FFM during ED are likely not influenced by anabolic hormone concentrations .


After renal transplantation , postoperative pain is usually mild to moderate .


Postoperative pain is a concern and administration of systemic analgesic may be difficult because of underlying co-morbidities and variable responses of the graft .


The transversus abdominis plane ( TAP ) block is one of the different approaches for postoperative pain relief following abdominal surgeries .


We evaluated analgesic efficacy of TAP block on early postoperative pain by numeric rating scale ( NRS ) and morphine consumption during the first 24 hours after kidney transplantation .


Forty-four patients , scheduled as kidney recipients were randomized into two equal groups and were anesthetized with the same technique .


After the induction of anesthesia , 15mL of 0.25 % Bupivacaine plus 5/ml epinephrine or saline was deposited into the transversus abdominis neuro-fascial plane on the side of surgery by ultrasound guide .


Each patient was assessed by a blinded investigator using NRS at 1st , 4th , 8th , 12th , and 24th hour postoperatively .


Demographic data were not significantly different between the study groups .


There was significant difference in median of NRS score measured at all time points in the study groups ( P < 0.001 ) .


The 24-hour morphine consumption ( meanSD ) was 10.89.5 mg in bupivacaine group compared with 41.23.8 mg in the saline group ( P = 0.001 ) .


There was statistically significant reduction in intraoperative fentanyl consumption in the TAP group 12020g compared to the control group 35824g ( P = 0.001 ) .


In study group 4 patients and in control group 90 patients received morphine titration for pain relief ( P = 0.03 ) .


There was no complication in the study groups related to nerve block .


Only two patients in saline group had nausea ( P = 0.07 ) .


None of our patients received any other oral or IV rescue medication .


Ultrasound TAP block can reduce postrenal transplantation pain and the amount of opioids consumption intraoperatively and during the first 24 hours after surgery in kidney recipients .


Elevated symmetric dimethylarginine ( SDMA ) has been shown to predict cardiovascular events and all cause mortality in diverse populations .


The potential role of SDMA as a risk marker in renal transplant recipients ( RTR ) has not been investigated .


We analyzed SDMA in the placebo arm of the Assessment of Lescol in Renal Transplantation study , a randomized controlled trial of fluvastatin in RTR .


Mean follow-up was 5.1 years .


Patients were grouped into quartiles based on SDMA levels at study inclusion .


Relationships between SDMA and traditional risk factors for graft function and all-cause mortality were analyzed in 925 RTR using univariate and multivariate survival analyses .


In univariate analysis , SDMA was significantly associated with renal graft loss , all-cause death , and major cardiovascular events .


After adjustment for established risk factors including estimated glomerular filtration rate , an elevated SDMA-level ( 4th quartile , > 1.38 mol/L ) was associated with renal graft loss ; hazard ratio ( HR ) , 5.51 ; 95 % confidence interval ( CI ) , 1.95-15 .57 ; P = 0.001 , compared to the 1st quartile .


Similarly , SDMA in the 4th quartile was independently associated with all-cause mortality ( HR , 4.56 ; 95 % CI , 2.15-9 .71 ; P < 0.001 ) , and there was a strong borderline significant trend for an association with cardiovascular mortality ( HR , 2.86 ; 95 % CI , 0.99-8 .21 ; P = 0.051 ) .


In stable RTR , an elevated SDMA level is independently associated with increased risk of all-cause mortality and renal graft loss .


Medication-overuse headache ( MOH ) is common in the general population .


We investigated effectiveness of brief intervention ( BI ) for achieving drug withdrawal in primary care patients with MOH .


The study was double-blind , pragmatic and cluster-randomised controlled .


A total of 25,486 patients ( age 18-50 ) from 50 general practitioners ( GPs ) were screened for MOH .


GPs defined clusters and were randomised to receive BI training ( 23 GPs ) or to continue business as usual ( BAU ; 27 GPs ) .


The Severity of Dependence Scale was applied as a part of the BI .


BI involved feedback about individual risk of MOH and how to reduce overuse .


Primary outcome measures were reduction in medication and headache days/month 3 months after the intervention and were assessed by a blinded clinical investigator .


42 % responded to the postal screening questionnaire , and 2.4 % screened positive for MOH .


A random selection of up to three patients with MOH from each GP were invited ( 104 patients ) , 75 patients were randomised and 60 patients included into the study .


BI was significantly better than BAU for the primary outcomes ( p < 0.001 ) .


Headache and medication days were reduced by 7.3 and 7.9 ( 95 % CI 3.2 to 11.3 and 3.2 to 12.5 ) days/month in the BI compared with the BAU group .


Chronic headache resolved in 50 % of the BI and 6 % of the BAU group .


The BI method provides GPs with a simple and effective instrument that reduces medication-overuse and headache frequency in patients with MOH .


NCT01314768 .


The aim of this study was to determine both the value of gadolinium-enhanced MRI in children with suspected acute appendicitis and the best sequences for detecting acute appendicitis , to thereby decrease imaging time .


This was a retrospective review of pediatric patients with suspected appendicitis who had undergone MRI at our institution between 2010 and 2011 after an indeterminate ultrasound examination .


MRI examinations included T1-weighted unenhanced and contrast-enhanced , T2-weighted , and balanced steady-state free precession ( SSFP ) sequences in axial and coronal planes .


Sequences were reviewed together and individually by five radiologists who were blinded to the final diagnosis .


Radiologists were asked to score their confidence of appendicitis diagnosis using a 5-point scale .


The diagnostic performance of each MR sequence was obtained by comparing the mean area under the curve ( AUC ) using receiver operating characteristic ( ROC ) analysis .


A total of 49 patients with clinically suspected appendicitis were included , of whom 16 received a diagnosis of appendicitis .


The mean AUCs for reviewing all sequences together , contrast-enhanced sequences alone , T2-weighted sequences alone , and balanced SSFP alone were 0.984 , 0.979 , 0.944 , and 0.910 , respectively .


No significant difference was observed between reviewing all sequences together versus contrast-enhanced sequences alone ( p = 0.90 ) and T2-weighted sequences alone ( p = 0.23 ) .


A significant difference was observed between contrast-enhanced sequences and balanced SSFP ( p < 0.03 ) .


Gadolinium-enhanced images and T2-weighted images are most helpful in the assessment of acute appendicitis in the pediatric population .


These findings have led to protocol modifications that have reduced imaging time .


There is an urgent need for more effective treatments for major depressive disorder ( MDD ) .


As understanding of the cognitive and affective neuroscience underlying psychiatric disorders expands , so do opportunities to develop interventions that capitalize on the capacity for brain plasticity .


Cognitive training is one such strategy .


In this article , we report a proof-of-concept study of a novel cognitive-emotional training exercise designed to enhance cognitive control for emotional information processing and targeting components of the neural networks that have been implicated in MDD .


Twenty-one participants with MDD in a current episode were randomly assigned to one of the two treatment conditions : 11 participating in a cognitive-emotional training paradigm ( emotional faces memory task ( EFMT ) ) involving eight sessions over 4 weeks , and 10 participating in an active control condition ( control training , CT ) .


Assessments of MDD symptoms , negative affective bias in cognitive processing , and neurocognition ( attention and working memory ) were administered at baseline and after 4 weeks .


Participants in the EFMT group exhibited a greater reduction in MDD symptoms compared to the CT group , and 6 of the 11 EFMT participants achieved clinical response ( 50 % reduction in symptoms ) .


EFMT participants also exhibited changes in negative affective bias in the hypothesized direction whereas the CT participants did not .


Both groups exhibited similar , small improvements in attention and working memory .


Cognitive-emotional training may represent a feasible and effective intervention strategy for MDD .


This proof-of-concept study highlights the need for future studies to fully understand the effectiveness , and mechanisms of effect , of these training strategies .


Uncertainty exists regarding the optimal method to estimate glomerular filtration rate ( GFR ) for disease detection and monitoring .


Widely used GFR estimates have not been validated in British ethnic minority populations .


Iohexol measured GFR will be the reference against which each estimating equation will be compared .


The estimating equations will be based upon serum creatinine and/or cystatin C.


The eGFR-C study has 5 components : 1 ) A prospective longitudinal cohort study of 1300 adults with stage 3 chronic kidney disease followed for 3 years with reference ( measured ) GFR and test ( estimated GFR [ eGFR ] and urinary albumin-to-creatinine ratio ) measurements at baseline and 3 years .


Test measurements will also be undertaken every 6 months .


The study population will include a representative sample of South-Asians and African-Caribbeans .


People with diabetes and proteinuria ( ACR 30 mg/mmol ) will comprise 20-30 % of the study cohort .2 ) A sub-study of patterns of disease progression of 375 people ( 125 each of Caucasian , Asian and African-Caribbean origin ; in each case containing subjects at high and low risk of renal progression ) .


Additional reference GFR measurements will be undertaken after 1 and 2 years to enable a model of disease progression and error to be built .3 ) A biological variability study to establish reference change values for reference and test measures .4 ) A modelling study of the performance of monitoring strategies on detecting progression , utilising estimates of accuracy , patterns of disease progression and estimates of measurement error from studies 1 ) , 2 ) and 3 ) .5 ) A comprehensive cost database for each diagnostic approach will be developed to enable cost-effectiveness modelling of the optimal strategy.The performance of the estimating equations will be evaluated by assessing bias , precision and accuracy .


Data will be modelled as a linear function of time utilising all available ( maximum 7 ) time points compared with the difference between baseline and final reference values .


The percentage of participants demonstrating large error with the respective estimating equations will be compared .


Predictive value of GFR estimates and albumin-to-creatinine ratio will be compared amongst subjects that do or do not show progressive kidney function decline .


The eGFR-C study will provide evidence to inform the optimal GFR estimate to be used in clinical practice .


ISRCTN42955626 .


Cardiovascular disease ( CVD ) accounts for 30 % of UK deaths .


It is associated with modifiable lifestyle factors , including insufficient consumption of fruit and vegetables ( F&V ) .


Lay health trainers ( LHTs ) offer practical support to help people develop healthier behaviour and lifestyles .


Our two-group pilot randomized controlled trial ( RCT ) investigated the effectiveness of LHTs at promoting a heart-healthy lifestyle among adults with at least one risk factor for CVD to inform a full-scale RCT .


Eligible adults ( aged 21-78 years ) , recruited from five practices serving deprived populations , were randomized to health information leaflets plus LHTs ' support for 3 months ( n = 76 ) versus health information leaflets alone ( n = 38 ) .


We recruited 114 participants , with 60 % completing 6 month follow-up .


Both groups increased their self-reported F&V consumption and we found no evidence for LHTs ' support having significant added impact .


Most participants were relatively less deprived , as were the LHTs we were able to recruit and train .


Our pilot demonstrated that an LHT 's RCT whilst feasible faces considerable challenges .


However , to justify growing investment in LHTs , any behaviour changes and sustained impact on those at greatest need should be demonstrated in an independently evaluated , robust , fully powered RCT .


To evaluate time-limited hydrotubation combined with clomiphene citrate as treatment for unexplained infertility .


In this unblinded , randomized controlled trial of patients who had unexplained infertility , 40 patients were treated with time-limited hydrotubation ( saline , 20 ml ; flushed within 20 to 30 seconds ) and clomphene citrate ( total , 70 cycles ) and 40 patients were treated with clomiphene citrate alone ( total , 74 cycles ) .


All women underwent an ovulation induction protocol with clomiphene citrate ( 100 mg/d orally for five days , from day 3 to day 7 of the cycle ) .


Hydrotubation was performed after detection of the dominant follicle .


There were 15 pregnancies in the 80 patients ( 19 % ) ( total , 144 stimulated cycles ; 10 % pregnancies per cycle ) .


The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate ( nine pregnancies per cycle [ 13 % ] ) than those treated with clomiphene citrate alone ( two pregnancies per cycle [ 3 % ] ; odds ratio , 5.3 ; 95 % confidence interval , 1.1 to 25.5 ; p 0.05 ) .


The frequency of pregnancy per patient ( total , clinical , or chemical ) was similar for the two treatment groups .


The frequency of live birth or abortion per cycle or patient was similar between the two treatment groups .


Time-limited hydrotubation and clomiphene citrate may increase the frequency of clinical pregnancy per cycle in women who have unexplained infertility .


Although colonoscopy is the standard procedure in the diagnosis of colorectal neoplasia , a significant number of clinical relevant lesions may be missed even by experienced endoscopists using current technology .


A transparent cap mounted at the tip of a colonoscope may be an easy way to extend the visual field during colonoscopy and may improve the detection rate of mucosal lesions .


The significance of cap assisted ( CAC ) vs. conventional colonoscopy ( CC ) on polyp detection rate was evaluated in a prospective randomized controlled trial in 504 patients .


CC and CAC detected polyps in 39.3 % and 31.8 , not significantly different .


There was also no significant difference between CAC and CC according to age , sex , indication for colonoscopy , diverticulosis , sedation , bowel cleansing , withdrawal time , time/number of attempts to intubate the cecal walve , number , localization , size or histology of polyps , .


However , the time to reach the cecal floor and the overall time of colonoscopy were significantly lower for CAC ( 1 minute ) .


CAC was without clinical impact on polyp detection rate or performance of colonoscopy .


Although most intensive care unit ( ICU ) admissions originate in the emergency department ( ED ) , a substantial number of admissions arrive from hospital wards .


Patients transferred from the hospital ward often share clinical characteristics with those admitted from the ED , but family expectations may differ .


An understanding of the impact of ICU admission source on family perceptions of end-of-life care may help improve patient and family outcomes by identifying those at risk for poor outcomes .


This was a cohort study of patients with chronic illness and acute respiratory failure requiring mechanical ventilation who died after admission to an ICU in any of the 14 participating hospitals in the Seattle-Tacoma area between 2003 and 2008 ( n = 1,500 ) .


Using regression models adjusted for hospital site and patient - , nurse - and family-level characteristics , we examined associations between ICU admission source ( hospital ward vs. ED ) and ( 1 ) family ratings of satisfaction with ICU care ; ( 2 ) family and nurse ratings of quality of dying ; ( 3 ) chart-based indicators of palliative care .


Admission from the hospital ward was associated with lower family ratings of quality of dying [ -0.90 , 95 % confidence interval ( CI ) -1.54 , -0.26 , p = 0.006 ] and satisfaction ( total score -3.97 , 95 % CI -7.89 , -0.05 , p = 0.047 ; satisfaction with care domain score -5.40 , 95 % CI -9.44 , -1.36 , p = 0.009 ) .


Nurses did not report differences in quality of dying .


Patients from hospital wards were less likely to have family conferences [ odds ratio ( OR ) 0.68 , 95 % CI 0.52 , 0.88 , p = 0.004 ] or discussion of prognosis in the first 72 h after ICU admission ( OR 0.72 , 95 % CI 0.56 , 0.91 , p = 0.007 ) but were more likely to receive spiritual care ( OR 1.48 , 95 % CI 1.14 , 1.93 , p = 0.003 ) or have life support withdrawn ( OR 1.38 , 95 % CI 1.04 , 1.82 , p = 0.025 ) .


Admission from the hospital ward is associated with family perceptions of a lower quality of dying and less satisfaction with ICU care .


Differences in receipt of palliative care suggest that family of patients from the hospital ward receive less communication .


Nurse ratings of quality of dying did not significantly differ by ICU admission source , suggesting dissimilarities between family and nurse perspectives .


This study identifies a patient population at risk for poor quality palliative and end-of-life care .


Future studies are needed to identify interventions to improve care for patients who deteriorate on the wards following hospital admission .


Hypericum perforatum ( St John 's wort ) is used to treat depression , but the effectiveness has not been established .


Recent guidelines described the analysis of clinical trials with missing data , inspiring the reanalysis of this trial using proper missing data methods .


The objective was to determine whether hypericum was superior to placebo in treating major depression .


A placebo-controlled , randomized clinical trial was conducted for 8 weeks to determine the effectiveness of hypericum or sertraline in reducing depression , measured using the Hamilton depression scale.We performed sensitivity analyses under different assumptions about the missing data process .


Three hundred forty participants were randomized , with 28 % lost to follow-up .


The missing data mechanism was not missing completely at random .


Under missing at random assumptions , some sensitivity analyses found no difference between either treatment armand placebo , while some sensitivity analyses found a significant difference from baseline to week 8 between sertraline and placebo ( -1.28 , 95 % credible interval [ -2.48 ; -0.08 ] ) , but not between hypericum and placebo ( 0.56 , [ -0.64 ; 1.76 ] ) .


The results were similar when the missing data process was assumed to be missing not at random .


There is no difference between hypericum and placebo , regardless of the assumption about the missing data process .


There is a significant difference between sertraline and placebo with some statistical-methods used .


It is important to conduct an analysis that takes account of missing data using valid statistically principled methods .


The assumptions about the missing data process could influence the results .


An important factor in the functional results after total knee arthroplasty is the achieved maximal flexion .


The main purpose of this study was to compare the maximal knee flexion one year after surgery in patients who received either the bicruciate substituting knee system or the conventional posterior stabilized system .


In a prospective randomized controlled trial , 124 patients presenting with osteoarthritis received the bicruciate substituting or the conventional posterior stabilized prosthesis .


The primary outcome was the maximum flexion angle at one year postoperatively on a lateral radiograph made with the supine patient using manual force to bend the knee .


Secondary outcomes were active flexion ( lying and standing ) , the Knee Society Score , the Patella Scoring System score , the University of California Los Angeles score , the number and type of adverse device effects , and visual analog scale satisfaction up to two years postoperatively .


The outcome measures of both groups were compared using one-sided t tests and non-parametric alternatives , with a significance level of p < 0.05 .


No significant differences between the two groups were observed in maximal flexion on radiographs and in active flexion at baseline .


The median maximal flexion on radiographs was 127 ( range , 83 to 150 ) for the bicruciate substituting group and 125 ( range , 74 to 145 ) for the conventional posterior stabilized group .


The two groups showed comparable two-year results with respect to the Knee Society Score , the Patella Scoring System , the University of California Los Angeles score , and visual analog scale satisfaction .


In the bicruciate substituting group , forty-one adverse device effects in twenty-six patients were reported , including three total system revisions and fourteen manipulations under anesthesia , compared with the conventional posterior stabilized group , in which sixteen adverse device effects were observed in thirteen patients , including six manipulations under anesthesia ( p = 0.012 ) .


Patients who receive a bicruciate substituting system compared with those who receive a conventional posterior stabilized system have comparable knee flexion characteristics and clinical and functional outcomes but more complications by two years after total knee arthroplasty .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Angiotensin II receptor blockers ( ARBs ) is a well-tolerated class of antihypertensive agents , exhibiting effective antihypertensive and cardiovascular protective function .


The objective of the study was to examine the efficacy and safety of Allisartan Isoproxil , a newly developed , selective , nonpeptide blocker of the angiotensin II type 1 receptor ( AT1R ) , in essential hypertensive patients at low-medium risk .


A Phase II prospective , randomized , double-blind , placebo-controlled , multicenter trial comparing Allisartan Isoproxil 240mg versus placebo was conducted in essential hypertensive patients at low-medium risk at 8 sites in China .


After a 2-week placebo baseline period , 275 patients received once-daily treatment with Allisartan Isoproxil 240mg or placebo randomly for 8 weeks .


Systolic/diastolic blood pressure ( SBP/DBP ) was measured at week 2 , 4 and 8 .


By the end of treatment , mean reductions from baseline of SBP and DBP in Allisartan Isoproxil and placebo groups were 14.5 / 10.4 and 8.3 / 7.7 mmHg , respectively ( P < 0.01 ) .


The rate of effective blood pressure control in Allisartan Isoproxil group was significantly higher than in placebo group at week 4 ( 61.3 % vs 50.0 % , P < 0.05 ) and week 8 ( 67.2 % vs 48.6 % , P < 0.01 ) .


In terms of safety and tolerability , there were no report of death and serious adverse event ( SAE ) in all subjects .


There was no difference of frequency between two groups in adverse event ( AE ) and adverse drug reaction ( ADR ) ( P > 0.05 ) .


No one withdraw because of an ADR in two groups .


124 patients received additional 56 weeks treatment with Allisartan Isoproxil and 84 of them completed the study .


The rate of effective BP control kept up to 80 % since week 24 .


No significant clinical change was observed and ADRs were generally mild or moderate during the long-term study .


Allisartan Isoproxil 240mg was effective and safe for essential hypertension patients at low-medium risk .


http://www.chictr.org/cn/ ChiCTR-TRC-10000886 .


Bipolar I disorder ( BD-I ) is a chronic mental illness characterized by the presence of one or more manic episodes , or both depressive and manic episodes , usually separated by asymptomatic intervals .


Pharmacists can contribute to the management of BD-I , mainly with the use of effective and safe drugs , and improve the patient 's life quality through pharmaceutical care .


Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses ; however , to our knowledge , there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD .


The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I .


Randomized , controlled , prospective , single-center clinical trial with duration of 12months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic .


Patients diagnosed with BD-I aged between 18 and 65years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic ( Antioquia , Colombia ) will be included .


Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists , or into the control group who will receive usual care and verbal-written counseling regarding BD .


Study outcomes will be assessed at baseline and at 3 , 6 , 9 , and 12months after randomization .


The primary outcome will be to measure the number of hospitalizations , emergency service consultations , and unscheduled outpatient visits .


Effectiveness , safety , adherence , and quality of life will be assessed as secondary outcomes .


Statistical analyses will be performed using two-tailed McNemar tests , Pearson chi-square tests , and Student 's t-tests ; a P value < 0.05 will be considered as statistically significant .


As far as we know , this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals , solution of drug-related problems , and adherence .


Registration number NCT01750255 on August 6 , 2012 .


First patient randomized on 24 November 2011 .


The disease process leading to clinical type 1 diabetes often starts during the first years of life .


Early exposure to complex dietary proteins may increase the risk of - cell autoimmunity in children at genetic risk for type 1 diabetes .


Extensively hydrolyzed formulas do not contain intact proteins .


To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children .


A double-blind randomized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries ; 1078 were randomized to be weaned to the extensively hydrolyzed casein formula and 1081 were randomized to be weaned to a conventional cows ' milk-based formula .


The participants were observed to April 16 , 2013 .


The participants received either a casein hydrolysate or a conventional cows ' milk formula supplemented with 20 % of the casein hydrolysate .


AND MEASURES : Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed .


Autoantibodies to insulin , glutamic acid decarboxylase , and the insulinoma-associated-2 ( IA-2 ) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years ( mean , 6.3 years ) .


The absolute risk of positivity for 2 or more islet autoantibodies was 13.4 % among those randomized to the casein hydrolysate formula ( n = 139 ) vs 11.4 % among those randomized to the conventional formula ( n = 117 ) .


The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those randomized to be weaned to the casein hydrolysate was 1.21 ( 95 % CI , 0.94-1 .54 ) , compared with those randomized to the conventional formula , while the hazard ratio adjusted for HLA risk , duration of breastfeeding , vitamin D use , study formula duration and consumption , and region was 1.23 ( 95 % CI , 0.96-1 .58 ) .


There were no clinically significant differences in the rate of reported adverse events between the 2 groups .


Among infants at risk for type 1 diabetes , the use of a hydrolyzed formula , when compared with a conventional formula , did not reduce the incidence of diabetes-associated autoantibodies after 7 years .


These findings do not support a benefit from hydrolyzed formula .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00179777 .


Postural control associated with self-paced movement is critical for balance in frail older adults .


The present work aimed to investigate the effects of a 2D virtual reality-based program on postural control associated with rapid arm movement in this population .


Participants in an upright standing position performed rapid arm-raising movements towards a target .


Practice-related changes were assessed by pre - and post-test comparisons of hand kinematics and centre-of-pressure ( CoP ) displacement parameters measured in a training group and a control group .


During these pre - and post-test sessions , patients have to reach towards yellow balls appearing on the screen , form a standardized upright position ( with 15cm between the two malleoli ) .


Training group patients took part in six sessions of virtual game .


In this , patients were asked to reach their arm towards yellow balls appearing on the screen , from an upright position .


After training , we observed improvements in arm movements and in the initial phase of CoP displacement , especially in the anticipatory postural adjustments .


Learning curves for these two types of motor improvements showed different rates .


These were continuous for the control of the arm movement , and discontinuous for the control of the CoP during the anticipatory postural adjustments .


These results suggest that some level of motor ( re ) - learning is maintained in frail patients with low functional reserves .


They also suggest that re-learning of anticipatory postural control ( i.e. motor prediction ) is less robust than explicit motor learning involved for the arm reaching .


This last point should encourage clinicians to extend the training course duration , even if reaching movement improvements seems acquired , in order to automate these anticipatory postural activities .


However , other studies should be done to measure the retention of these two types of learning on a longer-term period .


The hippocampal volume is reduced in patients with major depression .


Exercise leads to an increased hippocampal volume in schizophrenia and in healthy old adults .


The effect of exercise on hippocampal volume is potentially mediated by brain derived neurotrophic factor ( BDNF ) , vascular endothelial growth factor ( VEGF ) , and insulin like growth factor 1 ( IGF-1 ) .


The aim of this trial was to assess the effect of an aerobic exercise intervention on hippocampal volume and serum BDNF , VEGF , and IGF-1 in patients with major depression .


Patients were randomized to an aerobic exercise intervention ( n = 41 ) or a control condition ( n = 38 ) .


Both interventions consisted of three supervised sessions per week during a three months period .


Post-intervention the increase in maximal oxygen uptake was 3.90 ml/kg/min ( SD 5.1 ) in the aerobic exercise group and 0.95 ml/kg/min ( SD 6.2 ) in the control group ( p = 0.03 ) .


The hippocampal volume , BDNF , VEGF , or IGF-1 did not differ between the two groups .


Post-hoc we found a positive association between change in hippocampal volume and verbal memory ( Rho = 0.27 ; p = 0.05 ) and change in hippocampal volume and depressive symptoms ( Rho = 0.30 ; p = 0.03 ) .


Participation was low in both groups corresponding to an average participation of one session per week .


Despite a significant increase in maximal oxygen uptake , a pragmatic exercise intervention did not increase hippocampal volume or resting levels of neurotrophines in out-patients with mild to moderate major depression .


Trial identifier : ClinicalTrials.gov ( NCT00695552 ) .


Intra-lesional bony overgrowth ( BO ) identified during or following cartilage repair treatment is being frequently described through subjective reports focusing primarily on incidence .


Our objective was to quantify the exact volume of intra-lesional BO at 12 months post-cartilage repair treatment , to determine if a correlation exists between the extent of BO and clinical outcomes , and to visualize and characterize the BO .


MRI scans were systematically obtained during a randomized clinical trial for cartilage repair ( Stanish etal. , 2013 ) that compared two microfracture-based treatments in 78 patients .


Semi-automated morphological segmentation of pre-treatment , 1 and 12 months post-treatment scans utilizing a programmed anatomical atlas for all knee bone and cartilage structures permitted three-dimensional reconstruction , quantitative analysis , as well as qualitative characterization and artistic visualization ofBO .


Limited intra-lesional BO representing only 5.85.7 % of the original debrided cartilage lesion volume was found in 78 patients with available MRIs at 12 months .


The majority ( 80 % ) of patients had very little BO ( < 10 % ) .


Most occurrences of BO carried either spotty ( 56.4 % ) or planar ( 6.4 % ) morphological features , and the remaining balance ( 37.2 % ) was qualitatively unobservable by eye .


Pre-existing BO recurred at 12 months in the same intra-lesional location in 36 % of patients .


No statistical correlations were found between BO and clinical outcomes .


Intra-lesional BO following microfracture-based treatments may not be as severe as previously believed , its incidence is partly explained by pre-existing conditions , and no relationship to clinical outcomes exists at 12 months .


Morphologically , observable BO was categorized as comprising either spotty or planar bone .


To evaluate the role of post-surgical medical treatment with GnRHa in patients with DIE ( Deep Infiltrating Endometriosis ) that received complete or incomplete surgery laparoscopic excision .


Hundred fifty-nine patients with deep infiltrating endometriosis of the cul-de-sac and of the rectovaginal septum with pelvic pain undergoing laparoscopic surgery in academic tertiary-care medical center .


Eighty patients underwent complete laparoscopic excision of DIE ( Arm A ) while 79 patients underwent incomplete surgery ( Arm B ) .


After surgery each surgical arm was randomized in two groups : no treatment groups 1A [ 40 pts ] and 1B [ 40 pts ] and GnRHa treatment for 6 months groups 2A [ 40 pts ] and 2B [ 39 pts ] .


Pain recurrence and quality of life were evaluated in follow-up of 12 months and compared between groups .


No differences were observed between patient groups 1A and 2A .


Groups 1A , 2A and 2B obtained significantly lower pain scores than those achieved by the group 1B undergoing incomplete surgical treatment and no post-surgical therapy .


At 1-year follow-up patients treated with en-block resection ( Groups 1A and 2A ) showed the lowest pain scores and the highest quality of life in comparison with the other two groups ( Group 1B and 2B ) .


GnRHa administration is followed by a temporary improvement of pain in patients with incomplete surgical treatment .


It seems that it has no role on post-surgical pain when the surgeon is able to completely excise DIE implants .


Diminished quality of life ( QOL ) is associated with major depressive disorder ( MDD ) .


QOL was assessed in a post-hoc analysis of a double-blind , placebo-controlled trial .


Employed adult outpatients with MDD were randomly assigned to 12 weeks of treatment with desvenlafaxine 50mg/d or placebo .


Changes from baseline in the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) item scores at week 12 were analyzed using analysis of covariance with treatment , region , and baseline in the model .


Correlations between change from baseline in the 17-item Hamilton Rating Scale for Depression ( HAM-D17 ) total score and Q-LES-Q scores were computed .


The intent-to-treat population included 427 patients .


There were statistically significant improvements from baseline for desvenlafaxine vs placebo in 10 of 16 Q-LES-Q item scores ( P values 0.0441 ) .


The percentage of patients with severe QOL impairment ( 2 SD below community norm ) at week 12 was significantly lower for desvenlafaxine ( 46 % ) vs placebo ( 62 % ; P = 0.0024 ; baseline : 95 % and 94 % , respectively ) .


Change in Q-LES-Q total score was highly correlated with change in HAM-D17 score at week 12 , LOCF ( P < 0.0001 ) , and improvement in HAM-D17 total score at week 2 predicted change in Q-LES-Q total score at week 12 for the desvenlafaxine group ( F = 24.89 ; P < 0.0001 ) but not placebo .


This analysis excluded patients who were unemployed , had severe comorbidities , and those taking multiple , concomitant medications .


Improvement in QOL and depressive symptoms was significantly greater for employed depressed patients treated with desvenlafaxine vs placebo .


Although physical exercise improves motor aspects of Parkinson 's disease ( PD ) , it is not clear whether it may also have a neuroprotective effect .


Objective .


In this 2-year follow-up study , we determined whether intensive exercise in the early stages of the disease slows down PD progression .


Forty newly diagnosed patients with PD were treated with rasagiline and randomly assigned to 2 groups : MIRT Group ( two 28-day multidisciplinary intensive rehabilitation treatments [ MIRT ] , at 1-year interval ) and Control Group ( only drug ) .


In both groups , Unified Parkinson 's Disease Rating Scale Section II ( UPDRS II ) , UPDRS III , 6-minute walking test ( 6MWT ) , Timed Up-and-Go test ( TUG ) ; PD Disability Scale ( PDDS ) , and l-dopa equivalents were assessed at baseline ( T0 ) , 6 months ( T1 ) , 1 year ( T2 ) , 18 months ( T3 ) , and 2 years ( T4 ) later .


Over 2 years , UPDRS II , UPDRS III , TUG , and PDDS differentially progressed in the 2 groups : In the MIRT Group , all scores at T4 were better than at T0 ( all Ps < .03 ) .


No changes were noted in the Control Group .


l-dopa equivalent dosages increased significantly only in the Control Group ( P = .0015 ) , with a decrease in the percentages of patients in monotherapy ( T1 40 % ; T2 , T3 , and T4 20 % ) .


In the MIRT Group , the percentages of such patients remained higher ( T1 and T2 100 % ; T3 89 % ; T4 75 % ) .


These results suggest that MIRT might slow down the progression of motor decay , it might delay the need for increasing drug treatment , and thus , it might have a neuroprotective effect .


The aim of the present study was to investigate whether the following four markers : vitamin B12 , selenium , vitamin D , and parvalbumin may be used as compliance markers for fish intake .


Blood samples from a randomized cross-over herring intervention study ( n = 32 ) were analysed by HPLC and immunochemistry .


The criteria were that plasma or serum concentrations of candidate compliance markers after the herring diet should increase significantly compared to starting concentrations .


In addition , the reference meat diet should not yield an increase in plasma concentration of the candidate marker .


Vitamin B12 and selenium met the set criteria for indicating a correlation between the marker and fish intake with significant increases in serum concentrations at 8.9 % ( p = 0.008 ) and 4.6 % ( p = 0.02 ) , respectively , after a 6-week herring intervention ( 5 meals a week ) .


Parvalbumin and 25-hydroxy vitamin D3 levels did not increase significantly after the herring interventions .


Vitamin B12 may be suitable as a compliance marker for fish intake .


Although selenium also met the criteria , the change in selenium serum concentrations was small compared to the change in vitamin B12 levels .


To evaluate peripheral nerve safety and clinical efficacy of tanezumab in patients with painful osteoarthritis .


Patients received intravenous tanezumab 5mg , tanezumab 10mg , or placebo every 8 weeks for 24 weeks .


Neurological safety was evaluated via a composite score ( nerve conduction attributes and heart rate variability with deep breathing ; 5NC + HRdb ) , intraepidermal nerve fiber ( IENF ) density , and clinical assessments .


Efficacy and general safety were also evaluated .


The study was stopped prematurely by an FDA partial clinical hold ( joint safety issues in other studies ) .


Differences in change from baseline to Week 24 in 5NC + HRdb were not significant .


Tanezumab 5mg vs placebo exceeded the prespecified clinically important difference using last observation carried forward imputation , but not with observed data or when patients with evidence of neuropathy at baseline were excluded .


No significant differences were found in individual nerve conduction measures .


No treatment exceeded the prespecified clinically important decrease in IENF .


Tanezumab resulted in significant improvement in pain , physical function , and Patient 's Global Assessment .


Safety was similar to previous tanezumab clinical trials .


Tanezumab has a modulating effect on pain , does not appear to increase neurological safety signals , and offers a potentially promising , novel approach in treatment of pain .


To evaluate the safety of the performance of the traditional and protected collection techniques of tracheal aspirate and to identify qualitative and quantitative agreement of the results of microbiological cultures between the techniques .


Clinical , prospective , comparative , single-blind research .


The sample was composed of 54 patients of > 18 years of age , undergoing invasive mechanical ventilation for a period of 48 hours and with suspected Ventilator Associated Pneumonia .


The two techniques were implemented in the same patient , one immediately after the other , with an order of random execution , according to randomization by specialized software .


No significant events occurred oxygen desaturation , hemodynamic instability or tracheobronchial hemorrhage ( p < 0.05 ) and , although there were differences in some strains , there was qualitative and quantitative agreement between the techniques ( p < 0.001 ) .


Utilization of the protected technique provided no advantage over the traditional and execution of both techniques was safe for the patient .


The spot urine protein/creatinine ratio ( UPCR ) is proposed to be a substitute for 24-hour urinary protein ( 24h-UP ) .


This study is aimed to determine whether the predictive accuracy of 24h-UP using UPCR can be improved by simply multiplying estimated daily urine creatinine excretion ( eUCr ) and UPCR together .


This study enrolled 120 participants to investigate the correlation between spot UPCR and 24h-UP .