An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure , without recruitment manoeuvres .


Academic Medical Center ( Amsterdam , Netherlands ) , European Society of Anaesthesiology .


An objective measure of added sugar ( AS ) and sugar-sweetened beverage ( SSB ) intake is needed .


The ( 13 ) C value of finger-stick blood is a novel validated biomarker of AS/SSB intake ; however , nonsweetener corn products and animal protein also carry a ( 13 ) C value similar to AS sources , which may affect blood ( 13 ) C values .


The ( 15 ) N value of blood has been proposed as a `` correction factor '' for animal protein intake .


The objectives were to 1 ) identify foods associated with ( 13 ) C and ( 15 ) N blood values , 2 ) determine the contribution of nonsweetener corn to the diet relative to AS intake , and 3 ) determine if the dual-isotope model ( ( 13 ) C and ( 15 ) N ) is a better predictor of AS/SSB intake than ( 13 ) C alone .


A cross-sectional sample of southwest Virginian adults ( n = 257 ; aged 42 15 y ; 74 % overweight/obese ) underwent dietary intake assessments and provided finger-stick blood samples , which were analyzed for ( 13 ) C and ( 15 ) N values by using natural abundance stable isotope mass spectrometry .


Statistical analyses included ANOVAs , paired-samples t tests , and multiple linear regressions .


The mean SD daily AS intake was 88 59 g and nonsweetener corn intake was 13 13 g.


The mean ( 13 ) C value was -19.1 0.9 , which was significantly correlated with AS and SSB intakes ( r = 0.32 and 0.39 , respectively ; P 0.01 ) .


The ( 13 ) C value and nonsweetener corn intake and the ( 15 ) N value and animal protein intake were not correlated .


AS intake was significantly greater than nonsweetener corn intake ( mean difference = 76.2 57.2 g ; P 0.001 ) .


The ( 13 ) C value was predictive of AS/SSB intake ( range : 0.28-0 .35 ; P 0.01 ) ; however , ( 15 ) N was not predictive and minimal increases in R ( 2 ) values were observed when the ( 15 ) N value was added to the model .


The data do not provide evidence that the dual-isotope method is superior for predicting AS/SSB intakes within a southwest Virginian population .


Our results support the potential of the ( 13 ) C value of finger-stick blood to serve as an objective measure of AS/SSB intake .


This trial was registered at clinicaltrials.gov as NCT02193009 .


To comprehensively compare the effects of a very low-carbohydrate , high-unsaturated/low-saturated fat diet ( LC ) with those of a high-unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type 2 diabetes ( T2DM ) .


Obese adults ( n = 115 , BMI 34.4 4.2 kg/m ( 2 ) , age 58 7 years ) with T2DM were randomized to a hypocaloric LC diet ( 14 % carbohydrate [ < 50 g/day ] , 28 % protein , and 58 % fat [ < 10 % saturated fat ] ) or an energy-matched HC diet ( 53 % carbohydrate , 17 % protein , and 30 % fat [ < 10 % saturated fat ] ) combined with structured exercise for 24 weeks .


The outcomes measured were as follows : glycosylated hemoglobin ( HbA1c ) , glycemic variability ( GV ; assessed by 48-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score [ MES ] ) , and blood lipids and pressure .


A total of 93 participants completed 24 weeks .


Both groups achieved similar completion rates ( LC 79 % , HC 82 % ) and weight loss ( LC -12.0 6.3 kg , HC -11.5 5.5 kg ) ; P 0.50 .


Blood pressure ( -9.8 / -7.3 11.6 / 6.8 mmHg ) , fasting blood glucose ( -1.4 2.3 mmol/L ) , and LDL cholesterol ( -0.3 0.6 mmol/L ) decreased , with no diet effect ( P 0.10 ) .


LC achieved greater reductions in triglycerides ( -0.5 0.5 vs. -0.1 0.5 mmol/L ) , MES ( -0.5 0.5 vs. -0.2 0.5 ) , and GV indices ; P 0.03 .


LC induced greater HbA1c reductions ( -2.6 1.0 % [ -28.4 10.9 mmol/mol ] vs. -1.9 1.2 % [ -20.8 13.1 mmol/mol ] ; P = 0.002 ) and HDL cholesterol ( HDL-C ) increases ( 0.2 0.3 vs. 0.05 0.2 mmol/L ; P = 0.007 ) in participants with the respective baseline values HbA1c > 7.8 % ( 62 mmol/mol ) and HDL-C < 1.29 mmol/L .


Both diets achieved substantial improvements for several clinical glycemic control and CVD risk markers .


These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC .


This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks .


To evaluate the safety of electrocautery for coagulation during Caesarean sections .


A randomized , controlled , clinical pilot study was performed at a university maternity hospital .


After admission for delivery and decision to perform a C-section , volunteers were randomized to either the intervention group ( use of electrocautery for coagulation ) or nonintervention group .


The women were examined at the time of postpartum discharge ( day 3 ) , at days 7 to 10 , and again at days 30 to 40 for signs of infection , hematoma , seroma , or dehiscence .


Data were analyzed using an intention-to-treat analysis , and risk ratios were calculated .


No significant differences were found between the two groups .


Only 2.8 % of patients in the intervention group developed surgical wound complications during hospitalization .


However , 7 to 10 days following discharge , these rates reached 23.0 % and 15.4 % in the intervention and nonintervention groups , respectively ( RR = 1.50 , 95 % CI = 0.84-2 .60 ) .


Further studies should confirm whether the use of electrocautery for coagulation does not increase the risk of surgical wound complications in patients undergoing Caesarean sections .


The ToyBox-study developed an evidence - and theory-based intervention to improve preschoolers ' energy balance-related behaviours - including physical activity ( PA ) - by targeting the kindergarten environment and involving their parents/caregivers .


The present study aimed to examine the effect of the ToyBox-intervention on increasing Belgian preschoolers ' objectively measured PA levels .


A sample of 472 preschoolers ( 4.43 0.55 years ; 55.1 % boys ) from 27 kindergartens ( 15 intervention , 12 control kindergartens ) in Flanders , Belgium were included in the data analyses .


Preschoolers wore an ActiGraph accelerometer for six consecutive days and were included in the data analyses if they had a minimum of two weekdays and one weekend day , both at baseline and follow-up ( one year later ) .


Preschoolers ' PA outcomes were estimated for an average day , weekday , weekend day , during school hours , and during after school hours .


To assess intervention effects , multilevel repeated measures analyses were conducted for the total sample , and for sub-groups ( according to sex , kindergarten levels of socio-economic status ( SES ) and risk groups ( low levels of PA at baseline ) ) of preschoolers .


Small intervention effects were found in the total sample .


Most intervention effects were found in boys and in preschoolers from high SES kindergartens .


Boys from the intervention group had an increase in vigorous PA ( = 1.47 , p = 0.03 ) and moderate-to-vigorous PA ( = 1.27 , p = 0.03 ) from baseline to follow-up , whereas PA levels in boys from the control group stagnated or decreased .


In preschoolers from high SES kindergartens , the largest effects were found for PA outcomes during school hours and during after school hours .


The results from the Belgian sample demonstrate that effects of the PA-component of the ToyBox-intervention on objectively measured PA were found in preschool boys and in preschoolers from high SES kindergartens , which means that the ToyBox-intervention was mainly effective in those sub-groups .


Future interventions should search for alternative strategies to increase preschoolers ' PA levels in preschool girls and preschoolers from low SES kindergartens , as these are the most important at-risk groups regarding PA. .


The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion , among women as well as providers .


It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic .


This study protocol describes a study that is a randomised , controlled , non-superiority trial .


Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks .


The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared .


Randomization of the study participants will occur after the first clinical encounter with the doctor .


Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home , while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor .


The primary objective of the study this study protocol describes is to evaluate the efficacy of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion .


Providers or research assistants will not be blinded during outcome assessment .


To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation .


This resulted in an optimized , tailor-made intervention and in the development of the pictorial instruction sheet with a guide on how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion .


In this paper , we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment , 10-14 days after a medical abortion .


Moreover , a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor .


Clinicaltrials.gov NCT01827995 .


Registered 04 May 2013 .


The AeroChamber Plus ( AC ) valved holding chamber has been enhanced to include the Flow-Vu ( FV ) inspiratory flow indicator that provides visual inhalation feedback during use .


We have investigated if FV alters asthma control and whether parents accept it .


At visit 1 , children with asthma , age 1-5 years , used an AC with their pressurised metered dose inhaler and 2 weeks later ( visit 2 ) they were randomised to use either AC or FV .


Subjects returned 6 ( visit 3 ) and 12 ( visit 4 ) weeks later .


The Asthma Control ( ACQ ) and Paediatric Asthma Caregiver 's Quality of Life ( PACQLQ ) questionnaires were scored at each visit , and their peak inhalation flow ( PIF ) when they used their spacer was measured .


Forty participants in each group completed the study .


There was no difference in the ACQ scores from visits 2 to 4 between the two groups .


The improvements in the PACQLQ scores were greater in the FV group ( p = 0.029 ) .


The mean difference ( 95 % confidence interval ) for the change from visits 2 to 4 between FV and AC groups was 0.05 ( -0.33 , 0.43 ) and 0.39 ( 0.035 , 0.737 ) for the ACQ and PACQLQ , respectively .


Most parents preferred the FV ( p < 0.001 ) .


There was no difference in the PIF rates at each visit and between the two spacers .


There was no change in asthma control of the young children but that of their parents improved .


Parents preferred the FV and this could be related to their improved perception of their children 's asthma control by better PACQLQ scores .


The adverse effects of inadvertent perioperative hypothermia in the surgical population are well established .


The aim of this study was to investigate whether a resistive warming mattress would reduce the incidence of inadvertent perioperative hypothermia in patients undergoing elective caesarean section .


A total of 116 pregnant women booked for elective caesarean section were randomised to either intraoperative warming with a mattress or control .


The primary outcome was the incidence of inadvertent perioperative hypothermia , defined as a temperature < 36.0 C on admission to the recovery room .


Shivering in the perioperative period , severity of shivering and the need for treatment , total blood loss , fall in haemoglobin , incidence of blood transfusion , immediate health of baby , and length of hospital stay were also recorded .


The incidence of inadvertent perioperative hypothermia in the mattress-warmed group was significantly lower than in the control group ( 5.2 % vs. 19.0 % , P = 0.043 ) ; mean temperatures differed between the two groups , 36.5 C and 36.3 C , respectively ( P = 0.046 ) .


There was also a significantly lower mean ( SD ) haemoglobin change in the mattress-warmed group at -1.10.9 g/dL versus -1.60.9 g/dL in the control group ( P = 0.007 ) .


There was no difference in shivering ( P = 0.798 ) .


A resistive warming mattress reduced the incidence of inadvertent perioperative hypothermia and attenuated the fall in haemoglobin .


The use of resistive mattress warming should be considered during caesarean section .


Exercise-based cardiac rehabilitation increases peak oxygen uptake ( peak VO ) , which is an important predictor of mortality in cardiac patients .


However , it remains unclear which exercise characteristics are most effective for improving peak VO in coronary artery disease ( CAD ) patients .


Proof of concept papers comparing Aerobic Interval Training ( AIT ) and Moderate Continuous Training ( MCT ) were conducted in small sample sizes and findings were inconsistent and heterogeneous .


Therefore , we aimed to compare the effects of AIT and Aerobic Continuous Training ( ACT ) on peak VO , peripheral endothelial function , cardiovascular risk factors , quality of life and safety , in a large multicentre study .


Two-hundred CAD patients ( LVEF > 40 % , 90 % men , mean age 58.4 9.1 years ) were randomized to a supervised 12-week cardiac rehabilitation programme of three weekly sessions of either AIT ( 90-95 % of peak heart rate ( HR ) ) or ACT ( 70-75 % of peak HR ) on a bicycle .


Primary outcome was peak VO ; secondary outcomes were peripheral endothelial function , cardiovascular risk factors , quality of life and safety .


Peak VO ( ml/kg/min ) increased significantly in both groups ( AIT 22.7 17.6 % versus ACT 20.3 15.3 % ; p-time < 0.001 ) .


In addition , flow-mediated dilation ( AIT +34.1 % ( range -69.8 to 646 % ) versus ACT +7.14 % ( range -66.7 to 503 % ) ; p-time < 0.001 ) quality of life and some other cardiovascular risk factors including resting diastolic blood pressure and HDL-C improved significantly after training .


Improvements were equal for both training interventions .


Contrary to earlier smaller trials , we observed similar improvements in exercise capacity and peripheral endothelial function following AIT and ACT in a large population of CAD patients .


Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop , but there is a lack of standardized training for this procedure .


The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees ' performance at flexible nasolaryngoscopy .


Three-armed , single-blinded , randomized controlled study .


Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups .


All received a lecture and video presentation on flexible nasolaryngoscopy .


One group received additional tuition using a training mannequin .


The last group received mannequin training and feedback on their performance using a video recording .


The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded .


Blinded observers scored the trainees on a range of objective and subjective measures .


The volunteers who were also blinded to the candidates ' training scored the comfort of the procedure .


Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance .


Mannequin training together with video feedback produced significant performance improvement in patient comfort ( P = .0065 ) , time to reach the vocal folds ( P = .017 ) , and global ability ( P = .0006 ) .


Inter-rater reliability was excellent with P < .01 in all assessments .


Simulation-based training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients .


This study characterized a medically managed population in a non-ST-segment elevation acute coronary syndrome ( NSTEACS ) cohort and evaluated prognosis and outcomes of vorapaxar vs. placebo .


In the TRACER study , 12,944 NSTEACS patients were treated with standard care and vorapaxar ( a novel platelet protease-activated receptor-1 antagonist ) or placebo .


Of those , 4194 patients ( 32.4 % ) did not undergo revascularization during index hospitalization , and 8750 ( 67.6 % ) underwent percutaneous coronary intervention or coronary artery bypass grafting .


Patients managed medically were heterogeneous with different risk profiles , including 1137 ( 27.1 % ) who did not undergo coronary angiography .


Patients who underwent angiography but were selected for medical management included those without evidence of significant coronary artery disease ( CAD ) , with prior CAD but no new significant lesions , and with significant lesions who were not treated with revascularization .


Cardiovascular event rates were highest among those without angiography and lowest in the group with angiography but without CAD .


In the medically managed cohort , 2-year primary outcome ( cardiovascular death , myocardial infarction , stroke , recurrent ischaemia with rehospitalization , urgent coronary revascularization ) event rates were 16.3 % with vorapaxar and 17.0 % with placebo ( HR 0.99 , 95 % CI 0.83-1 .17 ) , with no interaction between drug and management strategy ( p = 0.75 ) .


Key secondary endpoint ( cardiovascular death , myocardial infarction , stroke ) rates were 13.4 % with vorapaxar and 14.9 % with placebo ( HR 0.89 , 95 % CI 0.74-1 .07 ) , with no interaction ( p = 0.58 ) .


Vorapaxar increased GUSTO moderate/severe bleeding numerically in medically managed patients ( adjusted HR 1.46 , 95 % CI 0.99-2 .15 ) .


NSTEACS patients who were initially medically managed had a higher risk-factor burden , and one-third had normal coronary arteries .


Outcome in the medically managed cohort was significantly related to degree of CAD , highlighting the importance of coronary angiography .


Efficacy and safety of vorapaxar appeared consistent with the overall trial results .


The Totaled Health Risks in Vascular Events ( THRIVE ) score strongly predicts clinical outcome , mortality , and risk of thrombolytic haemorrhage in ischemic stroke patients , and performs similarly well in patients receiving intravenous tissue plasminogen activator , endovascular stroke treatment , or no acute treatment .


It is not known if the THRIVE score predicts outcomes with the Solitaire endovascular stroke treatment device .


To validate the relationship between the THRIVE score and outcomes after treatment with the Solitaire endovascular stroke treatment device .


The study conducted a retrospective analysis of the prospective SWIFT and STAR trials to examine the relationship between THRIVE and outcomes after treatment with the Solitaire device .


We examined the relationship between THRIVE and clinical outcomes ( good outcome or death at 90days ) among patients in SWIFT and STAR .


Receiver-operator characteristics curve analysis was used to compare THRIVE score performance with other stroke prediction scores .


Multivariable modeling was used to confirm the independence of the THRIVE score from procedure-specific predictors ( successful recanalization or device used ) and other predictors of functional outcome .


The THRIVE score strongly predicts good outcome and death among patients treated with the Solitaire device in SWIFT and STAR ( Mantel-Haenszel chi-square test for trend P < 0001 for good outcome , P = 001 for death ) .


In receiver-operator characteristics ( ROC ) curve comparisons , totaled health risks in vascular events score is superior to Stroke Prognostication using Age and NIH Stroke Scale score-100 ( P < 0001 ) and performed similarly to Houston Intra-Arterial Therapy score ( HIAT ) ( P = 098 ) and HIAT-2 ( P = 054 ) .


In multivariable models , THRIVE 's prediction of good outcome is not altered after controlling for recanalization or after controlling for device used .


The THRIVE score remains a strong independent predictor after controlling for the above predictors together with time to procedure , rate of symptomatic haemorrhage , and use of general anesthesia .


Of note , use of general anesthesia was not an independent predictor of outcome in SWIFT+STAR after controlling for totaled health risks in vascular events and other factors .


The THRIVE score strongly predicts clinical outcome and mortality in patients treated with the Solitaire device in the SWIFT and STAR trials .


The lack of interaction between THRIVE and procedure-specific elements such as vessel recanalization or device choice makes the THRIVE score a reasonable candidate for use as a patient selection criterion in stroke clinical trials .


Individual placement and support ( IPS ) is effective in helping patients return to work but is poorly implemented because of clinical ambivalence and fears of relapse .


To assess whether a motivational intervention ( motivational interviewing ) directed at clinical staff to address ambivalence about employment improved patients ' occupational outcomes .


Two of four early intervention teams that already provided IPS were randomised to receive motivational interviewing training for clinicians , focused on attitudinal barriers to employment .


The trial was registered with the International Standard Randomised Controlled Trial Register ( ISRCTN71943786 ) .


Of 300 eligible participants , 159 consented to the research .


Occupational outcomes were obtained for 134 patients ( 85 % ) at 12-month follow-up .


More patients in the intervention teams than in the IPS-only teams achieved employment by 12 months ( 29/68 v. 12/66 ) .


A random effects logistic regression accounting for clustering by care coordinator , and adjusted for participants ' gender , ethnicity , educational and employment history and clinical status scores , confirmed superiority of the intervention ( odds ratio = 4.3 , 95 % CI 1.5-16 .6 ) .


Employment outcomes were enhanced by addressing clinicians ' ambivalence about their patients returning to work .


Lower body negative pressure ( LBNP ) decreases middle cerebral artery blood velocity ( MCAv ) and can induce hypotension .


Mental stress increases MCAv , but the MCAv response to combined LBNP and mental stress ( COMBO ) is unknown .


We hypothesized that performing a stressful cognitive challenge ( i.e. , mental stress ) concurrently with LBNP would prevent LBNP-induced reductions of MCAv .


There were 18 subjects ( 9 men , 9 women ; ages 20.10.3 yr ) who completed 3 randomized 3-min trials : 1 ) LBNP ( -40 mmHg ) ; 2 ) mental stress ( serial subtraction ) ; and 3 ) COMBO ( LBNP + mental stress ) .


All reported values are meanSE .


Mean arterial pressure ( MAP ) , heart rate ( HR ) , forearm blood flow ( FBF ) , and MCAv were measured continuously .


Subjects also reported perceived stress following the mental stress and COMBO trials .


LBNP decreased MAP ( -1.40.5 mmHg ) , MCAv ( -2.61.1 cm s ( -1 ) ) and FBF ( -0.80.1 units ) , and increased HR ( 2.71.2 bpm ) .


Mental stress increased MAP ( 10.11.3 mmHg ) , HR ( 17.42.2 bpm ) , and FBF ( 2.40.4 units ) , while MCAv ( 2.81.3 cm s ( -1 ) ) tended to increase .


COMBO increased MAP ( 5.32.3 mmHg ) and HR ( 21.32.6 bpm ) , and tended to increase FBF ( 0.50.3 units ) .


However , MCAv ( -4.62.0 cm s ( -1 ) ) decreased during COMBO .


Decreases in MCAv during COMBO were not statistically different from LBNP-induced decreases ( -4.62.0 vs. -2.61.1 cm s ( -1 ) ) .


Subjective ratings of perceived stress ( standard 0 to 4 scale ) tended to be higher during COMBO than mental stress ( 2.90.1 vs. 2.50.1 units ) .


Our results suggest that mental stress does not effectively preserve MCAv when combined with central hypovolemia ( i.e. , LBNP ) .


A number of clinical trials have shown that patients with overt atherovascular disease may benefit from more aggressive dosage of statins .


We aimed to determined the usual dosage of statin in clinical practice and the adherence to recommended target concentration of LDL-cholesterol .


We analyzed 948 patients with mean age 64.5 years ( SD 9.0 ) after acute coronary syndrome and/or coronary revascularization ( Czech samples of EUROASPIRE III and IV ) .


In spite that more than 93 % of patients were in 2012/2013 treated with statin , only 2.4 % with the highest dose ( atorvastatin 80 mg or equivalent ) .


On the other hand , medium-dosed statin ( atorvastatin 40 mg ) was more often prescribed , in comparison to 2006/2007 .


We observed mild improvement in adherence to former LDL-cholesterol target < 2.5 mmol/l ( from 54 % to 65 % ) , but the recent target < 1.8 mmol/l was reached only in less than one quarter of patients in 2012/2013 .


It can be approximate ( using individual LDL-cholesterol values ) , that after maximal possible up-titration of statin , the adherence to recent LDL-cholesterol target may improve up to 43 % .


Although the majority of CHD patients are currently being treated with statin , the usual dosage regimen and adherence to the recommended target values were not consistent with current therapeutic standards for secondary prevention of CHD .


Among the multiple nonsurgical modalities , epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis .


There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up .


Randomized , double-blind , active-controlled trial with 2-year follow-up .


An interventional pain management practice in the United States .


The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis .


Two groups of patients were studied , with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone .


The primary outcome measure was defined as pain relief and functional status improvement of 50 % .


The outcomes were assessed by numeric rating scale ( NRS ) of pain and functional status with Oswestry Disability Index ( ODI ) .


Secondary outcome measures included employment status and opioid intake .


Results showed significant improvement in 60 % of patients in Group I and 70 % of patients in Group II at the end of 2 years .


In addition , in the successful groups , those with at least 3 weeks of relief ( with the first 2 procedures ) , the improvement was 72 % in Group I and 71 % in Group II .


Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group .


Thus , the results indicate that a patient 's failure to respond to local anesthetic alone , may be treated with addition of steroids .


The results of the study are limited by the lack of a placebo group .


Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality , in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities .


Distal radius fractures are among the most common fractures and account for approximately one-sixth of all fractures diagnosed .


Therapy results after distal radius fracture , especially of elderly patients , are often suboptimal .


The inevitable immobilization for several weeks leads to reduction in range of motion , deterioration of muscle strength , malfunction of fine motor skills as well as changes of motor and sensory representations in the brain .


Currently , there are no strategies to counteract these immobilization problems .


The overall aim of the study is to investigate the therapeutic potential of motor-cognitive approaches ( mental practice or mirror therapy ) on hand function after wrist fracture .


This study is a controlled , randomized , longitudinal intervention study with three intervention groups .


One experimental group imagines movements of the fractured upper extremity without executing them ( mental practice ) .


The second experimental group receives a mirror therapy program consisting of the performance of functional movement synergies using the unaffected forearm , wrist , and hand .


The control group completes a relaxation training regime .


Additionally , all patients receive usual care by the general practitioner .


We include women aged 60 years and older having a distal radius fracture and sufficient cognitive function .


All groups are visited at home for therapy sessions 5 times per week for the first 3 weeks and 3 times per week for weeks 4 to 6 .


Measurements are taken at therapy onset , and after 3 , 6 and 12 weeks .


The primary outcome measure will assess upper extremity functioning ( Patient-Rated Wrist Evaluation [ PRWE ] ) , while secondary outcome measures cover subjective wrist function ( Disabilities of the Arm and Shoulder ; [ DASH ] , objective impairment ( range of motion , grip force ) and quality of life ( EuroQol-5D , [ EQ5D ] ) .


Results from this trial will contribute to the evidence on motor-cognitive approaches in the early therapy of distal radius fractures .


The trial is registered at ClinicalTrials.gov with registration number NCT01394809 and was granted permission by the Medical Ethical Review Committee of the University of Tbingen in June 2011 .


We evaluated eating behaviors and quality of life ( QOL ) in preadolescent children at risk for obesity , with and without abdominal pain ( AP ) .


Participants were parent-child dyads enrolled in a randomized , controlled obesity prevention trial .


The children were between 5 and 10 years of age and at risk for obesity ( 70th-95th percentile of body mass index , n = 420 ) .


Parents completed measures of their child 's eating behaviors , QOL , AP , and bowel function and their own depression status , concern about child weight , and feeding practices .


Children 's height and weight were also measured .


Children with frequent AP ( 2/month , n = 103 ) were compared with children reporting infrequent AP ( < 2/month , n = 312 ) .


Age and body mass index did not differ between groups , but AP was more prevalent in girls .


Child emotional overeating and parental depression scores were higher in the frequent AP group ( P < 0.01 ) , and child QOL was lower ( P < 0.01 ) .


In multivariable analysis , female gender ( odds ratio [ OR ] 2.18 , 95 % confidence interval [ CI ] 1.20-3 .97 ) , emotional overeating ( OR 2.28 , 95 % CI 1.37-3 .81 ) , and parental depression ( OR 1.23 , 95 % CI 1.12-1 .35 ) were associated with more frequent AP .


Secondary analyses were completed for children who met Rome III criteria for irritable bowel syndrome .


Clinicians working with children with AP at risk for obesity should consider assessing for and , when appropriate , addressing parent and child factors that could exacerbate AP .


The efficacy of macrolides in chronic rhinosinusitis ( CRS ) is still under controversy .


To date , only two double-blind , placebo-controlled studies have been published with differing results .


None of these studies investigated the possible benefit of macrolides in the postoperative period .


We conducted an investigator-initiated clinical trial using 250-mg erythromycin once a day over a period of 3 months , beginning the administration of either erythromycin or placebo 2 weeks after a surgical intervention for CRS .


Randomized double-blind , placebo-controlled trial .


The concentrations of eosinophilic cationic protein ( ECP ) and myeloperoxidase in nasal secretion were chosen as primary outcome measures .


Additionally , as a secondary outcome measure , changes in the Sino-Nasal Outcome Test-20 score , olfaction , saccharin transit time , nasal endoscopy score , and self-rating of nasal health using a visual analogue scale were evaluated .


Sixty-seven patients after surgery for CRS with or without nasal polyps were screened , and 58 patients were randomized to the study groups .


For the primary outcomes , the concentrations of ECP changed from 176.4 l/l79 .0 to 226.1 l/l200 .6 in the erythromycin group and from 186.9 l/l36 .0 to 192.9 l/l189 .2 in the placebo group ; no statistical differences were found .


Of the secondary outcomes , only the nasal endoscopy score showed a statistically significant improvement in the erythromycin group ( from 2.61.4 to 1.91.5 points ) compared to the placebo group ( from 2.51.3 to 2.61.5 points ) .


The subgroup of patients without nasal polyps in the erythromycin group showed a tendency to improvement in some secondary outcome criteria .


A general recommendation for long-term , low-dose erythromycin treatment after surgery for CRS can not be given .


In patients with CRS without nasal polyps , a tendency to improved parameters was detected .


Ib .


The purpose of this study is to evaluate the effects of an 8-week exercise-based cardiac rehabilitation program on traditional and nonlinear heart rate variability ( HRV ) indexes , assessing the potential confounding influences of habitual physical activity ( PA ) and dietary intake .


In this parallel-group trial , 96 patients ( 56 10 years old ) were randomized to the exercise group ( EG ) or to the control group ( CG ) 4 weeks after an acute myocardial infarction .


Exercise-based cardiac rehabilitation program consisted of aerobic exercise at 70 % to 85 % of maximal heart rate for 3 sessions per week plus usual care .


The CG received only usual care .


The baseline and final assessments comprised resting short-term HRV ( primary outcome ) by a Polar R-R recorder under controlled breathing ( 12 breaths per minute ) , habitual PA by accelerometers , and dietary intake by a 4-day food diary .


Two patients in each group dropped out and were not included in the intention-to-treat analysis .


In the remaining 92 patients ( EG = 47 and CG = 45 ) , at baseline , only a difference in the proportion of nitrate medication use was significant between groups .


After 8 weeks , no significant changes were found between groups on traditional and nonlinear HRV indexes ( eg , ln HF , EG from 5.7 1.5 to 5.9 1.3 and CG from 5.5 1.6 to 5.5 1.5 ) , habitual PA , and dietary intake .


Eight weeks of exercise-based cardiac rehabilitation program is an insufficient stimulus to improve cardiac autonomic function in post-myocardial infarction patients under optimal medication and with high levels of traditional and nonlinear HRV indexes at baseline .


The modulation of gut microbiota is considered to be the first target to establish probiotic efficacy in a healthy population .


This study was conducted to determine the impact of a probiotic on the intestinal microbial ecology of healthy volunteers .


High-throughput 16S ribosomal RNA gene sequencing was used to characterize the fecal microbiota in healthy adults ( 23-55 y old ) of both sexes , before and after 4 wk of daily consumption of a capsule containing at least 24 billion viable Lactobacillus paracasei DG cells , according to a randomized , double-blind , crossover placebo-controlled design .


Probiotic intake induced an increase in Proteobacteria ( P = 0.006 ) and in the Clostridiales genus Coprococcus ( P = 0.009 ) , whereas the Clostridiales genus Blautia ( P = 0.036 ) was decreased ; a trend of reduction was also observed for Anaerostipes ( P = 0.05 ) and Clostridium ( P = 0.06 ) .


We also found that the probiotic effect depended on the initial butyrate concentration .


In fact , participants with butyrate > 100 mmol/kg of wet feces had a mean butyrate reduction of 49 21 % and a concomitant decrease in the sum of 6 Clostridiales genera , namely Faecalibacterium , Blautia , Anaerostipes , Pseudobutyrivibrio , Clostridium , and Butyrivibrio ( P = 0.021 ) , after the probiotic intervention .


In contrast , in participants with initial butyrate concentrations < 25 mmol/kg of wet feces , the probiotic contributed to a 329 255 % ( mean SD ) increment in butyrate concomitantly with an 55 % decrease in Ruminococcus ( P = 0.016 ) and a 150 % increase in an abundantly represented unclassified Bacteroidales genus ( P = 0.05 ) .


The intake of L. paracasei DG increased the Blautia : Coprococcus ratio , which , according to the literature , can potentially confer a health benefit on the host .


The probiotic impact on the microbiota and on short-chain fatty acids , however , seems to strictly depend on the initial characteristics of the intestinal microbial ecosystem .


In particular , fecal butyrate concentrations could represent an important biomarker for identifying subjects who may benefit from probiotic treatment .


This trial was registered at www.controlled-trials.com/isrctn as ISRCTN56945491 .


Vitiligo is an acquired skin disorder with great social impact .


It can be successfully treated using cultured autologous melanocytes transplantation .


To evaluate the effect of different modalities of narrow-band ultraviolet B ( NB-UVB ) therapy on the outcome of cultured autologous melanocyte transplantation in treating vitiligo .


Patients undergoing cultured autologous melanocyte transplantation were randomly assigned to four different study groups .


Group 1 underwent 20 sessions of NB-UVB treatment before transplantation ; Group 2 underwent 30 sessions of NB-UVB treatment after transplantation ; Group 3 underwent 20 sessions of NB-UVB treatment before transplantation and 30 sessions after transplantation ; Group 4 underwent only transplantation .


Four hundred thirty-seven patients were enrolled .


Group 3 responded best , more than 90 % repigmentation was achieved in 81.3 % of patients , and 94.8 % patients experienced 50 % or greater repigmentation .


Statistical analysis showed that there was a highly significant difference between the four groups ( ( 2 ) = 35.56 , p < .001 ) .


Homogeneous skin color was obtained on the repigmentation areas , and no scarring or other serious side effects were observed .


Cultured autologous melanocyte transplantation is an effective treatment for stable vitiligo .


Combination of NB-UVB therapy with melanocyte transplantation can accelerate repigmentation of transplanted vitiliginous areas , especially if NB-UVB is given before and after transplantation .


To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis .


Randomized controlled trial .


Five neurosurgical centers ( including one academic and four secondary level care centers ) in the Netherlands .


203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011 ; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized .


80 participants received an interspinous process device and 79 participants underwent spinal bony decompression .


The primary outcome at short term ( eight weeks ) and long term ( one year ) follow-up was the Zurich Claudication Questionnaire score .


Repeated measurements were made to compare outcomes over time .


At eight weeks , the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group ( 63 % , 95 % confidence interval 51 % to 73 % ) was not superior to that for standard bony decompression ( 72 % , 60 % to 81 % ) .


No differences in disability ( Zurich Claudication Questionnaire ; P = 0.44 ) or other outcomes were observed between groups during the first year .


The repeat surgery rate in the interspinous implant group was substantially higher ( n = 21 ; 29 % ) than that in the conventional group ( n = 6 ; 8 % ) in the early post-surgical period ( P < 0.001 ) .


This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional `` simple '' decompression and even showed a fairly high reoperation rate after interspinous process device implantation .


Dutch Trial Register NTR1307 .


Despite the increasing need to identify and implement effective interventions to reduce drinking with mandated college students , peer-led brief alcohol interventions have received minimal research attention .


The current pilot study tested whether enhanced supervision ( evidence-based application approach [ EAA ; group plus individual ] ) would improve peer counseling skills beyond those acquired by a common practice approach ( CPA ; group only ) .


Following initial peer counselor skill evaluation , drinking outcomes after intervention were compared between supervision groups with a mandated college student sample ( N = 82 ; 65 men ) .


The relationship between acquired motivational interviewing skills and subsequent drinking behaviors was also assessed .


EAA peer counselors showed higher motivational interviewing skill acquisition than CPA peer counselors .


Despite differences in counselor skill demonstration , mandated clients in both intervention groups significantly reduced drinking behaviors .


Further , higher reflection-to-question ratio and motivational interviewing spirit demonstrated by peer counselors were significantly related to poorer follow-up drinking outcomes .


Findings identify supervision practices that may result in optimal peer counselor learning and brief intervention implementation while also offering initial data about the way in which peer counseling session implementation may relate to drinking outcomes .


Future research is needed to identify the within-session processes of peer-led interventions that predict drinking outcomes , which may offer additional direction for training approaches .


It is estimated that up to two thirds of patients presenting with ST-segment-elevation myocardial infarction have multivessel disease .


The optimal strategy for treating nonculprit disease is currently under debate .


This study provides a real-world analysis comparing a strategy of culprit-vessel intervention ( CVI ) versus multivessel intervention at the time of primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction .


We compared CVI versus multivessel intervention in 3984 patients with multivessel disease undergoing primary percutaneous coronary intervention between 2004 and 2011 at all 8 tertiary cardiac centers in London .


Multivariable-adjusted models were built to determine independent predictors for in-hospital major adverse cardiovascular events ( MACEs ) and all-cause mortality at 1 year .


To reduce confounding and bias , propensity score methods were used .


CVI was associated with reduced in-hospital MACE ( 4.6 % versus 7.2 % ; P = 0.010 ) and mortality at 1 year ( 7.4 % versus 10.1 % ; P = 0.031 ) .


CVI was an independent predictor for reduced in-hospital MACE ( odds ratio , 0.49 ; 95 % confidence interval [ CI ] , 0.32-0 .75 ; P < 0.001 ) and survival at 1 year ( hazard ratio , 0.65 ; 95 % CI , 0.47-0 .91 ; P = 0.011 ) in the complete cohort ; and in 2821 patients in propensity-matched cohort ( in-hospital MACE : odds ratio , 0.49 ; 95 % CI , 0.32-0 .76 ; P = 0.002 ; and 1-year survival : hazard ratio , 0.64 ; 95 % CI , 0.45-0 .90 ; P = 0.010 ) .


Inverse probability treatment weighted analyses also confirmed CVI as an independent predictor for reduced in-hospital MACE ( odds ratio , 0.38 ; 95 % CI , 0.15-0 .96 ; P = 0.040 ) and survival at 1 year ( hazard ratio , 0.44 ; 95 % CI , 0.21-0 .93 ; P = 0.033 ) .


In this observational analysis of patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , CVI was associated with increased survival at 1 year .


Acknowledging the limitations with observational analyses , our findings support current recommended practice guidelines .


In 2006 there were 432,700 people in Australia who had acquired brain injury ( ABI ) with some limitation of activities ; 90 % of these were traumatic brain injuries ( TBIs ) and nearly a third sustained injury below age 15years .


One to four years post injury , 20 % to 46 % of children with traumatic brain injury ( TBI ) have clinically significant disorders of attention .


There is controversy as to whether central nervous system ( CNS ) stimulants can be an effective method of treating these.Objectives were to determine the efficacy of CNS stimulants for children with TBI , and to calculate the sample size for a larger trial using the Conners ' 3 Parent Rating Scales Score as the primary endpoint .


Pilot series of aggregated prospective randomised , double-blind , n-of-1 trials of stimulant versus placebo within individual patients .


tertiary children 's public hospital .


ten children aged 6 to 16years more than 12months post TBI with attention , concentration and behavioral difficulties on stimulants .


Three cycles of methylphenidate or dexamphetamine orally at doses titrated by physician compared to placebo .


Conners 3 Parent ( Conners 3-P ) and Teacher ( Conners 3-T ) Rating Scales ( Global Index ) , Behaviour Rating Inventory of Executive Function ( BRIEF ) and Eyberg Child Behaviour Inventory ( ECBI ) .


Five of ten patients completed the study .


Data from 18 completed cycles from seven patients were analysed .


The posterior mean difference between stimulant and placebo scores for the Conners 3-PS ( Global Index ) was 2.3 ( SD 6.2 ; 95 % credible region -1.0 to 6.1 ; posterior probability that this mean difference was greater than zero was 0.92 ) , and for the Conners 3-T ( Global Index ) the posterior mean difference was 5.9 ( SD 4.5 ; 95 % credible region -3.1 to 14.9 ; posterior probability 0.93 ) .


Posterior mean differences suggest improvement in behaviour and executive function and a decrease in number and intensity of child behaviour problems when taking stimulants compared to placebo .


Taken together these data are suggestive of a small benefit at group level .


In this pilot study , there was sufficient evidence that stimulants may be useful in management of behavioral and cognitive sequelae following TBI , to warrant a larger trial .


he trial was registered with the Australian and New Zealand Clinical Trials Registry : registration number ACTRN12609000873224 .


To investigate the effects of maxillary protraction combined with repetitive rapid palatal expansions and constrictions ( RPE/C ) vs. rapid palatal expansion ( RPE ) alone using cone-beam computed tomography ( CBCT ) .


Twenty four subjects with maxillary retrusion were recruited and block randomized into either the control group ( n = 12 ) or the RPE/C ( n = 12 ) group .


facemask protraction after RPE .


RPE/C group : facemask protraction after RPE/C .


3D reconstruction , landmarks identifying , superimposition and cephalometric analysis were performed to compare the pre-treatment and post - treatment CBCT images .


One subject in the RPE/C group was lost to follow up during the treatment .


Maxilla moved forward [ ( 2.51.0 ) mm ] after maxillary protraction with RPE/C , which was significantly greater than that in the control group [ ( 1.60.8 ) mm ] ( P < 0.05 ) .


The distance of basion to subspinale ( Ba-A ) increased [ ( 3.11.0 ) mm ] in the RPE/C group , which was significantly greater than that in the control group [ ( 2.2 0.9 ) mm ] ( P < 0.05 ) .


The amount of forward movement of upper first molars was significantly greater in the RPE/C group ( P < 0.05 ) .


Maxillary protraction with RPE/C might positively affect the forward movement of maxilla compared with the RPE alone protocol with the early treatment of maxillary retrusion patients .


Subcutaneous pegylated interferon ( peginterferon ) beta-1a is being developed for treatment of relapsing multiple sclerosis , with less frequent dosing than currently available first-line injectable treatments .


We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial , a study of patients with relapsing-remitting multiple sclerosis .


We did this 2-year , double-blind , parallel group , phase 3 study , with a placebo-controlled design for the first 48 weeks , at 183 sites in 26 countries .


Patients with relapsing-remitting multiple sclerosis ( age 18-65 years , with Expanded Disability Status Scale score 5 ) were randomly assigned ( 1:1:1 ) via an interactive voice response or web system , and stratified by site , to placebo or subcutaneous peginterferon beta-1a 125 g once every 2 weeks or every 4 weeks .


The primary endpoint was annualised relapse rate at 48 weeks .


This trial is registered with ClinicalTrials.gov , number NCT00906399 .


We screened 1936 patients and enrolled 1516 , of whom 1512 were randomly assigned ( 500 to placebo , 512 to peginterferon every 2 weeks , 500 to peginterferon every 4 weeks ) ; 1332 ( 88 % ) patients completed 48 weeks of treatment .


Adjusted annualised relapse rates were 0397 ( 95 % CI 0328-0481 ) in the placebo group versus 0256 ( 0206-0318 ) in the every 2 weeks group and 0288 ( 0234-0355 ) in the every 4 weeks group ( rate ratio for every 2 weeks group 0644 , 95 % CI 0500-0831 , p = 00007 ; rate ratio for the every 4 weeks group 0725 , 95 % CI 0565-0930 , p = 00114 ) .


417 ( 83 % ) patients taking placebo , 481 ( 94 % ) patients taking peginterferon every 2 weeks , and 472 ( 94 % ) patients taking peginterferon every 4 weeks reported adverse events including relapses .


The most common adverse events associated with peginterferon beta-1a were injection site reactions , influenza-like symptoms , pyrexia , and headache .


76 ( 15 % ) patients taking placebo , 55 ( 11 % ) patients taking study drug every 2 weeks , and 71 ( 14 % ) patients taking study drug every 4 weeks reported serious adverse events ; relapse , pneumonia , and urinary tract infection were the most common .


After 48 weeks , peginterferon beta-1a significantly reduced relapse rate compared with placebo .


The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments .


Biogen Idec .


This randomized , double-blind , and placebo-controlled trial evaluated the effect of isolated daidzein and genistein on glycemic control and insulin sensitivity in 165 Chinese women aged 30-70 with impaired glucose regulation ( IGR ) .


Participants were randomly assigned to one of three groups with a daily dose of 10 g of soy protein plus ( i ) no addition , ( ii ) 50 mg of daidzein , or ( iii ) 50 mg of genistein for 24 wk .


Fasting glucose ( FG ) , insulin , and glycosylated hemoglobin ( HbA1c ) , and glucose concentrations at 30 , 60 , 120 , and 180 min and insulin concentrations at 30 , 60 , and 120 min after an oral 75-g glucose tolerance test were assessed at baseline and at 12 and 24 wk postintervention .


a total of 158 and 151 subjects completed the measures at wk 12 and 24 , respectively .


There were no significant differences in the changes ( % ) of FG and the 2-h glucose , HbA1c , fasting , and 2-h insulin or the area under the curve of glucose and insulin between the three treatment groups at wk 12 or 24 ( all p > 0.05 ) .


Neither isolated daidzein nor genistein has a significant effect on glycemic control and insulin sensitivity in Chinese women with IGR over a 6-month supplementation period .


Although there have been several reports that statins cause insulin resistance that leads to the occurrence of type 2 diabetes in Caucasians , there has been no Japanese prospective studies investigating the effects of statins on the glucose metabolism system .


Our subjects were 86 Japanese patients with type 2 diabetes with hypercholesterolemia .


Pitavastatin 2mg/day was administered for 12 months and the lipid-related values , glucose metabolism values , and the presence/absence of side effects were investigated .


None of these factors was found to differ between before and after administration of pitavastatin in overall analysis of all subjects .


In subgroup analysis , fasting blood glucose showed a decrease in the BMI 25 group and there was a significant difference between the BMI < 25 and BMI 2 5 groups ( P-values : 0.021 and 0.0036 ) .


Although HbA1c showed an increase both in the group switched to pitavastatin and the BMI < 25 group ( P-values : 0.035 and 0.033 ) and HOMA - showed a decrease in the BMI < 25 group ( P-values : 0.044 ) , there were no significant differences in changes between each divided group and their counterparts .


In the Japanese obese group with BMI 25 , pitavastatin elicited a significant decrease in fasting blood glucose .


It is not clear whether or not this is due to improved insulin resistance as a direct effect of pitavastatin , but in contrast to findings in Caucasians pitavastatin does not worsen insulin resistance in Japanese patients with type 2 diabetes complicated by hypercholesterolemia .


The aim of this in vitro study is to evaluate the effects of three different caries removal techniques on the microtensile bond strength of adhesive materials to caries-affected dentin .


Thirty primary molar teeth were used .


The teeth were randomly divided into three groups according to the caries removal technique employed : conventional steel bur ( group 1 ) ; Er : YAG laser ( group 2 ) ; chemomechanical method ( group 3 ) .


Each group was divided into two subgroups according to bonding agents : one-step self-etch adhesive and etch-and-rinse adhesive .


The teeth were restored with composite resin .


Vertical sticks were obtained and subjected to tensile stress .


Data were analyzed by two-way analysis of variance ( ANOVA ) , Tukey 's test and an independent samples t-test .


The values for the laser groups were significantly lower than those of the bur groups for both bonding agents ( p < 0.05 ) .


There were no significant differences between the bur and chemomechanical groups ( p > 0.05 ) .


Bur and chemomechanical techniques in primary teeth were found more successful .


Similar results were found according to the adhesives used for each caries removal techniques .


The administration of single dose intrathecal ( IT ) morphine with local anesthetics during spinal anesthesia produces an effective postoperative analgesia .


In this study , we evaluated the efficacy and safety of two different doses of IT morphine with bupivacaine for postoperative analgesia after transurethral resection of prostate ( TURP ) .


Prospective , randomized study .


Urology Department .


Sixty patients who were scheduled to undergo TURP with spinal anesthesia .


Patients were allocated to receive IT morphine ( 75 g ) with bupivacaine heavy ( group I ) and IT morphine ( 150 g ) with bupivacaine heavy ( group II ) .


Postoperative pain was evaluated by Visual Analogous Scale during 24 hours .


The need for rescue analgesia , adverse effects and patient satisfaction were recorded .


Groups were comparable with respect to demographic data .


VAS scores were similarly low in both groups .


However , the request for analgesia was significantly higher in group I ( 27 percent ) than group II ( 7 percent ; p = 0.04 ) .


The incidence of postoperative nausea was similarly low in both groups .


No patients reported pruritis in group I where as six patients ( 20 percent ) reported mild pruritis not necessitating treatment in group II ( p = 0.036 ) Patients satisfaction was similarly high in both the groups .


IT morphine 150 g reduced the need for rescue analgesia compared to IT morphine 75 g in patients undergoing TURP under spinal anesthesia .


As the incidence of pruritis was low with no treatment , IT morphine 150 g may be a suitable dose for postoperative analgesia for patients undergoing TURP under spinal anesthesia .


Specialized Early Intervention services ( SEI ) for first episode psychosis are shown to be effective for the treatment of positive and negative symptoms , medication adherence , rates of relapse , substance abuse disorders , functional outcome and quality of life at two-year treatment follow up .


However , it is also reported that these benefits are not maintained when SEI is not sustained .


The objective of this trial is to test the efficacy of a 3-year extension of a SEI service ( following 2 years of SEI prior to randomization ) for the maintenance and consolidation of therapeutic gains as compared to regular care in the community .


Following an initial 2 years of SEI , patients are randomized to receive either 3-years of continued SEI or regular care .


SEI provided at three sites within the McGill network of SEI services , using a model of treatment comprised of : modified assertive case management ; psycho education for families ; multiple family intervention ; cognitive behavioural therapy ; and substance abuse treatment and monitoring .


Blinded research assistants conduct ongoing evaluation of the outcome variables every three months .


The primary outcome measure is remission status measured both as the proportion of patients in complete remission and the mean length of remission achieved following randomization during the additional three years of follow up .


Based on preliminary data , it is determined that a total of 212 patients are needed to achieve adequate statistical power .


Intent to treat with the last observation carried forward will be the primary method of statistical analysis .


The `` critical period '' hypothesis posits that there is a five year window during which the effects of the nascent psychotic illness can be countered and the impact of the disorder on symptomatic and functional outcomes can be offset through active and sustained treatment .


Providing SEI throughout this critical period may solidify the benefits of treatment such that gains may be more sustainable over time as compared to intervention delivered for a shorter period .


Findings from this study will have implications for service provision in first episode psychosis .


ISRCTN11889976 .


To assess the effectiveness of a child care center-based parent and teacher healthy lifestyle role-modeling program on child nutrition and physical activity outcomes .


Child care centers ( N = 28 ) serving low-income families were randomized to intervention or control arms .


Intervention centers ( N = 12 ) implemented ( 1 ) menu modifications , ( 2 ) a child 's healthy lifestyle curriculum , and ( 3 ) an adult ( teacher - and parent-focused ) healthy lifestyle role-modeling curriculum .


Control centers ( N = 16 ) received an attention control safety curriculum .


Nutrition and physical activity data were collected at the beginning ( T1 ) and at the end ( T2 ) of the school year .


Exploratory factor analysis identified positive and negative nutrition and physical activity practices by children , parents , and teachers .


Intervention parents ' baseline ( = .52 , p < .0001 ) and school year consumption ( = .47 , p < .0001 ) of fruits/vegetables significantly increased their children 's consumption of fruits/vegetables from T1 to T2 .


Intervention parents significantly influenced a decrease in children 's junk food consumption ( = -.04 , p < .05 ) , whereas control parents significantly influenced an increase in their children 's junk food consumption ( = .60 , p < .001 ) from T1 to T2 .


Control children showed a significant increase in junk food consumption ( = .11 , p = .01 ) and sedentary behavior ( = .09 , p < .005 ) from T1 to T2 .


Teachers did not significantly influence preschool-age children 's nutrition or physical activity patterns from T1 to T2 .


Parent nutrition and physical activity patterns significantly influence their preschool-age children 's consumption of fruits/vegetables , junk food , and level of sedentary behavior .


Future obesity prevention intervention efforts targeting this age group should include parents as healthy lifestyle role models for their children .


Our objective was to compare the pain/stress levels of newborns among the 2 most common circumcision techniques after resident-wide education .


The study period of this randomized control trial was October 2012 through March 2014 .


Following informed consent , full-term males from uncomplicated singleton pregnancies were randomized to Gomco ( n = 137 ) or Mogen ( n = 137 ) devices .


Resident-wide education for an obstetrics and gynecology residency program at a single institution was performed to ensure standardized training .


All infants received a subcutaneous ring block before the procedure and oral sucrose intraoperatively .


The primary outcome was neonatal pain assessed physiologically by salivary cortisol levels ( enzyme-linked immunosorbent assay ) and clinically by a validated neonatal pain score ( crying , requires increased oxygen administration , increased vital signs , expression , sleeplessness [ CRIES ] ) .


Secondary outcomes were immediate complications , duration of procedure , and short-term outcomes as reported by mothers and pediatricians .


A sample size of 274 ( accounting for 20 % loss of follow-up ) was determined sufficient to detect a mean difference of 1.22 g/dL in cortisol levels ( Gomco , SD3 .34 ; Mogen , SD0 .81 ) with 80 % power , P = .05 level of significance .


A total of 251 infants completed the protocol .


There were no significant differences in maternal or neonatal demographics including preoperative heart rate and mean arterial pressure .


In the Mogen circumcision , the percentage change of cortisol was significantly lower than Gomco ( 279.1498.15 vs 167.75272.22 ; P = .049 ) .


There were no differences in postoperative CRIES scores .


Postoperative heart rate was higher in infants undergoing Gomco circumcision than Mogen circumcision ( 138.716.5 vs 133.417.5 ; P = .015 ) as was mean arterial blood pressure ( 63.39.2 vs 60.48.6 ; P = .012 ) .


Mogen circumcisions were shorter ( 7.002.97 vs 3.651.84 minutes ; P < .001 ) .


There were no significant differences in bleeding complications .


A total of 168 maternal surveys were completed , with 98.7 % maternal satisfaction in Gomco vs 98.9 % in Mogen .


There were no reports of bleeding after discharge or circumcision revisions in either group to date .


Mogen clamp is associated with less neonatal pain physiologically by significantly lower percentage change in salivary cortisol , lower heart rate , and mean arterial blood pressure .


There was no difference in CRIES scores .


Mogen clamp circumcision duration is significantly shorter than Gomco clamp .


Both methods demonstrate satisfactory maternal and pediatrician short-term follow-up .


Remote ischaemic preconditioning ( RIPC ) , using brief cycles of limb ischaemia/reperfusion , is a non-invasive , low-cost intervention that may reduce perioperative myocardial injury ( PMI ) in patients undergoing cardiac surgery .


We investigated whether RIPC can also improve short-term clinical outcomes .


One hundred and eighty patients undergoing elective coronary artery bypass graft ( CABG ) surgery and/or valve surgery were randomised to receive either RIPC ( 2-5min cycles of simultaneous upper arm and thigh cuff inflation/deflation ; N = 90 ) or control ( uninflated cuffs placed on the upper arm and thigh ; N = 90 ) .


The study primary end point was PMI , measured by 72h area under the curve ( AUC ) serum high-sensitive troponin-T ( hsTnT ) ; secondary end point included short-term clinical outcomes .


RIPC reduced PMI magnitude by 26 % ( -9.303 difference ( CI -15.618 to -2.987 ) 72h hsTnT-AUC ; p = 0.003 ) compared with control .


There was also evidence that RIPC reduced the incidence of postoperative atrial fibrillation by 54 % ( 11 % RIPC vs 24 % control ; p = 0.031 ) and decreased the incidence of acute kidney injury by 48 % ( 10.0 % RIPC vs 21.0 % control ; p = 0.063 ) , and intensive care unit stay by 1day ( 2.0 days RIPC ( CI 1.0 to 4.0 ) vs 3.0 days control ( CI 2.0 to 4.5 ) ; p = 0.043 ) .


In a post hoc analysis , we found that control patients administered intravenous glyceryl trinitrate ( GTN ) intraoperatively sustained 39 % less PMI compared with those not receiving GTN , and RIPC did not appear to reduce PMI in patients given GTN .


RIPC reduced the extent of PMI in patients undergoing CABG and/or valve surgery .


RIPC may also have beneficial effects on short-term clinical outcomes , although this will need to be confirmed in future studies .


ClinicalTrials.gov ID : NCT00397163 .


Quality of life ( QoL ) is considered an important outcome in health research .


It can be rated by the patient , or by an external assessor .


We wished to identify the predictors of any discrepancies between these two approaches in people with schizophrenia .


Patients with DSM schizophrenia and related disorders ( N = 80 ) completed both patient-rated ( Lancashire Quality of Life Profile ; LQOLP ) and assessor-rated ( Heinrich 's Quality of Life Scale ; QLS ) measures of QoL .


Patient-rated ( LQOLP ) and assessor-rated ( QLS ) measures showed a modest correlation ( r = 0.38 ) .


In a regression analysis , independent predictors of subjectively-rated QoL being higher than objectively-assessed QoL in the same patient , were low insight score ( BIS ) , negative symptoms ( PANSS ) , absence of depression ( CDSS ) , and less positive attitude toward prescribed treatment ( DAI ) .


In people with schizophrenia , scores on objectively - and subjectively-rated measures of quality of life can differ markedly .


When comparing subjective to objective assessments , patients with depressive symptoms will value their QoL lower , and those with low insight will value their QoL higher .


This has important implications for the utility and interpretation of QoL measures in schizophrenia .


Low serum levels of high density lipoprotein cholesterol ( HDL-C ) is an established risk factor for coronary heart disease ( CHD ) .


Among a variety of lipid modifying drugs , the best single drug therapy to increase HDL-C levels , especially among high risk , isolated low HDL-C ( ILHDL-C ) cases is yet to be identified .


The objectives of the present study were to evaluate the best pharmacological measure among atorvastatin , fenofibrate and niacin aimed to raise HDL-C and its effect in decreasing the estimated Framingham-10-year CHD risk percentage ( CHD-RP ) among high risk ILHDL-C cases in north India .


Two hundred CHD equivalent ( CHD-RP20 ) , ILHDL-C cases were randomly assigned for treatment either with atorvastatin 10 mg/day ( n = 70 ) , micronized fenofibrate 160 mg/day ( n = 65 ) or niacin-extended release ( ER ) 750 mg/day ( n = 65 ) .


After 6 wk of treatment , the dosages of drugs were doubled and the patients were finally assessed after 12 wk for their lipid values .


Baseline characteristics were similar in the three groups .


Niacin therapy 750 mg and 1.5 g/day resulted in a significant rise in HDL-C by 8.10 3.19 and 12.41 4.39 per cent ( P < 0.001 ) , respectively .


Fenofibrate 160 and 320 mg/day also resulted in a significant rise in HDL-C by 3.85 3.48 and 6.24 4.43 per cent ( P < 0.001 ) , respectively , while atorvastatin 10 and 20 mg/day resulted in a non-significant increase in HDL-C by 0.13 2.92 per cent and 0.51 2.63 per cent , respectively .


By increasing HDL-C values , niacin was found to be most effective in reduction of 10-year CHD-RP ( P < 0.001 ) , followed by fenofibrate ( P = 0.010 ) , while atorvastatin had no effect .


Our findings indicate that niacin rather than fibrates or statins seems to provide a safe and effective therapy for increasing HDL-C , thus reducing the cumulative CHD risk among ILHDL-C cases .


Calcineurin inhibitors ( CNIs ) are essential immunosuppressive drugs after renal transplantation .


Because of nephrotoxicity , withdrawal has been a challenge since their introduction .


A randomized multicenter trial included 212 kidney patients transplanted between 1997 and 1999 .


All patients were initially treated with mycophenolate mofetil ( MMF ) , cyclosporine A ( CsA ) , and prednisone ( pred ) .


At 6 months after transplantation , 63 patients were randomized for MMF/pred , 76 for MMF/CsA , and 73 for MMF/CsA/pred .


Within 18 months after randomization 23 patients experienced a rejection episode : MMF/pred ( 27.0 % ) , MMF/CsA ( 6.8 % ) and MMF/CsA/pred ( 1.4 % ) ( P < 0.001 ) .


During 15 years of follow-up , 73 patients died with a functioning graft , and 43 patients lost their graft .


Ninety-six were alive with a functioning graft .


Intention-to-treat analysis did not show a significant difference in patient and graft survival .


In multivariate analysis , death-censored graft survival was significantly associated with serum creatinine at 6 months after transplantation and maximum PRA but not with the randomization group .


CNI withdrawal did not result in a reduced incidence of or death by malignancy or cardiovascular disease .


Death-censored graft survival was significantly worse in those patients randomized for CNI withdrawal that had to be reverted to CNI .


Independent of randomization group , compared with no rejection , death-censored graft survival was significantly worse in 23 patients with acute rejection after randomization .


Fifteen years after conversion to a CNI free regimen , there was no benefit regarding graft and patient survival or regarding prevalence of or death by comorbidities .


However , rejection shortly after CNI withdrawal was associated with decreased graft survival .


To report the safety of intravitreal ocriplasmin injection based on 2 Phase 3 clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction , including when associated with full-thickness macular holes .


Safety analyses were based on 2 completed Phase 3 studies assessing intravitreal ocriplasmin injection .


Adverse events ( AEs ) , serious AEs , and suspected adverse drug reactions are reported .


The authors also report AEs of special interest from 8 other completed Phase 2 studies and 2 ongoing studies .


A total of 465 eyes were injected with ocriplasmin ( 125 g ) , and 187 eyes were treated with placebo injection in Phase 3 studies .


Overall AE rate was 69.0 % in the placebo group and 76.6 % for ocriplasmin-treated patients .


Most AEs were in the study eye , mild or moderate in severity , and transient .


All suspected adverse drug reactions were ocular ; the majority was nonserious , of mild intensity , and transient .


Intravitreal ocriplasmin injection provides a generally well-tolerated pharmacologic treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction , including when associated with full-thickness macular holes 400 m in diameter .


The majority of mid-life and older adults in the UK are not achieving recommended physical activity levels and inactivity is associated with many health problems .


Walking is a safe , appropriate exercise .


The PACE-UP trial sought to increase walking through the structured use of a pedometer and handbook , with and without support from a practice nurse trained in behaviour change techniques ( BCTs ) .


Understanding barriers and facilitators to engagement with a primary care based physical activity intervention is essential for future trials and programmes .


We conducted semi-structured telephone interviews using a topic guide with purposive samples of participants who did and did not increase their walking from both intervention groups .


Interviews were audio-recorded , transcribed and coded independently by researchers prior to performing a thematic analysis .


Responsiveness to the specific BCTs used was also analysed .


Forty-three trial participants were interviewed in early 2014 .


Almost all felt they had benefitted , irrespective of their change in step-count , and that primary care was an appropriate setting.Important facilitators included a desire for a healthy lifestyle , improved physical health , enjoyment of walking in the local environment , having a flexible routine allowing for an increase in walking , appropriate self and external monitoring and support from others.Important barriers included physical health problems , an inflexible routine , work and other commitments , the weather and a mistrust of the monitoring equipment.BCTs that were reported to have the most impact included : providing information about behaviour-health link ; prompting self-monitoring and review of goals and outcomes ; providing feedback ; providing specific information about how to increase walking ; planning social support/change ; and relapse prevention .


Rewards were unhelpful .


Despite our expectation that there would be a difference between the experiences of those who did and did not objectively increase their walking , we found that most participants considered themselves to have succeeded in the trial and benefitted from taking part .


Barriers and facilitators were similar across demographic groups and trial outcomes .


Findings indicated several BCTs on which PA trial and programme planners could focus efforts with the expectation of greatest impact as well as strong support for primary care as an appropriate venue .


ISRCTN98538934 .


this study investigated the influence of anatomical predictors on difficult laryngoscopy and orotracheal intubation in obese patients by comparing Macintosh and Airtraq laryngoscopes .


from 132 bariatric surgery patients ( body mass index 35 kgm ( -1 ) ) , cervical perimeter , sternomental distance , interincisor distance , and Mallampati score were recorded .


The patients were randomized into two groups according to whether a Macintosh ( n = 64 ) or an Airtraq ( n = 68 ) laryngoscope was used for tracheal intubation .


Time required for intubation was the first outcome .


Cormack-Lehane score , number of intubation attempts , the Macintosh blade used , any need for external tracheal compression or the use of gum elastic bougie were recorded .


Intubation failure and strategies adopted were also registered .


intubation failed in two patients in the Macintosh laryngoscope group , and these patients were included as worst cases scenario .


The intubation times were 36.9 +22.8 s and 13.7 +3.1 s for the Macintosh and Airtraq laryngoscope groups ( p < 0.01 ) , respectively .


Cormack-Lehane scores were also lower for the Airtraq group .


One patient in the Macintosh group with intubation failure was quickly intubated with the Airtraq .


Cervical circumference ( p < 0.01 ) and interincisor distance ( p < 0.05 ) influenced the time required for intubation in the Macintosh group but not in the Airtraq group .


in obese patients despite increased neck circumference and limited mouth opening , the Airtraq laryngoscope affords faster tracheal intubation than the Macintosh laryngoscope , and it may serve as an alternative when conventional laryngoscopy fails .


In this prospective trial we compared ultralow dose computerized tomography reconstruction algorithms and routine low dose computerized tomography for detecting urolithiasis .


A total of 48 consenting adults prospectively underwent routine low dose noncontrast computerized tomography immediately followed by an ultralow dose series targeted at a 70 % to 90 % reduction from the routine low dose technique ( sub mSv range ) .


Ultralow dose series were reconstructed with filtered back projection , and adaptive statistical and model based iterative reconstruction techniques .


Transverse ( axial ) and coronal images were sequentially reviewed by 3 relatively inexperienced trainees , including a radiology resident , a urology fellow and an abdominal imaging fellow .


Three experienced abdominal radiologists independently reviewed the routine low dose filtered back projection images , which served as the reference standard .


The mean effective dose for the ultralow dose scans was 0.91 mSv ( median 0.82 ) , representing a mean SD 78 % 5 % decrease compared to the routine low dose .


Overall sensitivity and positive predictive value per stone for ultralow dose computerized tomography at a 4 mm threshold was 0.91 and 0.98 , respectively .


Sensitivity , specificity , positive and negative predictive values , and accuracy per patient were 0.87 , 1.00 , 1.00 , 0.94 and 0.96 , respectively .


At a 4 mm threshold the sensitivity and positive predictive value per stone of the ultralow dose series for filtered back projection , and adaptive statistical and model based iterative reconstruction was 0.89 and 0.96 , 0.91 and 0.98 , and 0.93 and 1.00 , respectively .


Sensitivity , specificity , positive and negative predictive values , and accuracy per patient at the 4 mm threshold were 0.82 , 1.00 , 1.00 , 0.91 and 0.94 for filtered back projection , 0.85 , 1.00 , 1.00 , 0.93 and 0.95 for adaptive statistical iterative reconstruction , and 0.94 , 1.00 , 1.00 , 0.97 and 0.98 for model based iterative reconstruction , respectively .


Sequential review of coronal images changed the final stone reading in 13 % of cases and improved diagnostic confidence in 49 % .


At a 4 mm renal calculus size threshold ultralow dose computerized tomography is accurate for detection when referenced against routine low dose series with dose reduction to below the level of a typical 2-view plain x-ray ofthekidneys , ureters and bladder .


Slight differences were seen among the reconstruction algorithms .


There was mild improvement with model based iterative reconstruction over filtered back projection and adaptive statistical iterative reconstruction .


Coronal images improved detection and diagnostic confidence over axial images alone .


This secondary analysis of data from a randomised controlled trial explores associations between common symptom clusters and evaluates pre-treatment to post-treatment changes in clinical levels of these symptoms following cognitive behaviour therapy for insomnia ( CBT-I ) .


Baseline data from 113 participants with insomnia were explored to establish rates of and associations between clinical levels of fatigue , anxiety and depression across the sample .


Effects of CBT-I on this symptom cluster were also explored by examining changes in pre-treatment to post-treatment levels of fatigue , anxiety and depression .


At baseline , the most common symptom presentation was insomnia + fatigue , and 30 % of the sample reported at least three co-morbid symptoms .


Post-CBT , the number of those experiencing clinical insomnia and clinical fatigue decreased .


There were no changes in anxiety rates from baseline to post-treatment in the CBT group and modest reductions in rates of those with clinical depression .


Seven individuals ( 9.6 % ) from the CBT group were completely symptom free at post-treatment compared with 0 % from the treatment as usual condition .


Chi-square analysis revealed a significant relationship between group allocation and changes in symptoms of insomnia and fatigue .


No such relationship was found between group allocation and mood variables .


These findings confirm the high rate of symptom co-morbidities among cancer patients and highlight strong associations between sleep and fatigue .


CBT-I appears to offer generalised benefit to the symptom cluster as a whole and , specifically , is effective in reducing fatigue , which exceeded clinical cut-offs prior to implementation of the intervention .


This has implications for the diagnosis/management of common symptoms in cancer patients .


Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required .


However , despite the increasing number of school-based interventions to prevent obesity , results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status .


The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours .


A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of ; the trial design ( including the trial outcomes ) and the HeLP Programme and whether it is able to engage schools , children and their families .


Data was collected using interviews with teachers ( n = 12 ) and parents ( n = 17 ) and six focus groups with children ( n = 47 ) and a questionnaire for parents of children in the intervention schools .


Interview and focus group data relating to the intervention was analysed using framework analysis .


Four schools and 201 children participated in the exploratory trial .


The data showed that the trial design was feasible and acceptable for schools and children .


Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme ( value , compatibility with the curriculum and enjoyment ) and two themes emerged in relation to engagement ( ` knowledge and awareness ' and ` taking messages on board ' ) .


The latter could be broken down into 4 subthemes ( ` initiating discussion with family and friends ' , ` acceptance of family rules ' , ` increased responsibility ' and ` the importance of the mode and agent of delivery ' ) .


The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home , seek parental support and initiate family lifestyle behaviour change .


The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme , it has also allowed an understanding of how HeLP engages schools , children and their families .


These findings have informed the process evaluation for the definitive trial .


The aim of this study was to evaluate the shear bond strength to dentin of primary molars of a new self-adhering flowable resin composite with two ionomer-based cements and one flowable resin composite in combination with two different adhesive systems .


Fifty primary molars were grinded on the occlusal surface to obtain flat dentin substrate and randomly divided into 5 groups ( n = 10 ) : OFL : Phosphoric Acid/Optibond FL/Premise Flow ; OAO : Optibond All-In-One/Premise Flowable ; II : Polyacrylic Acid/Fuji II ; IX : Polyacrylic Acid/Fuji IX ; V : Vertise Flow .


Cylinders ( 3mm diameter - 5mm height ) of restorative material were built-up in three increments over the dentin surfaces .


A shear load was applied until failure .


Bond strength values were statistically analysed with Kruskall-Wallis ANOVA followed by Dunn 's test ( P < .05 ) .


Differences in failure mode distribution were assessed with Chi-square ( P < .05 ) .


OFL and OAO recorded significantly higher bond strengths than the other groups .


Adhesive failures were evident in all groups except OFL and OAO , in which also cohesive failures in dentin were observed .


Vertise Flow established on primary dentin bond strengths values similar to those of glass ionomer cements routinely used for restorations of primary teeth .


The combination of flowable resin with etch-and-rinse or all-in-one adhesives obtained higher bond strength values , thus involving a more complex handling .


Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events .


Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients .


We compared the angiotensin-neprilysin inhibitor LCZ696 ( 400 mg daily ) with the angiotensin-converting enzyme inhibitor enalapril ( 20 mg daily ) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial .


The analyses focused on prespecified measures of nonfatal clinical deterioration .


In comparison with the enalapril group , fewer LCZ696-treated patients required intensification of medical treatment for heart failure ( 520 versus 604 ; hazard ratio , 0.84 ; 95 % confidence interval , 0.74-0 .94 ; P = 0.003 ) or an emergency department visit for worsening heart failure ( hazard ratio , 0.66 ; 95 % confidence interval , 0.52-0 .85 ; P = 0.001 ) .


The patients in the LCZ696 group had 23 % fewer hospitalizations for worsening heart failure ( 851 versus 1079 ; P < 0.001 ) and were less likely to require intensive care ( 768 versus 879 ; 18 % rate reduction , P = 0.005 ) , to receive intravenous positive inotropic agents ( 31 % risk reduction , P < 0.001 ) , and to have implantation of a heart failure device or cardiac transplantation ( 22 % risk reduction , P = 0.07 ) .


The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization .


Worsening of symptom scores in surviving patients was consistently more common in the enalapril group .


LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury ( N-terminal pro-B-type natriuretic peptide and troponin ) versus enalapril .


Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition .


http://www.clinicaltrials.gov .


Unique identifier : NCT01035255 .


Acute kidney injury ( AKI ) is observed in up to 41 % of patients undergoing transcatheter aortic valve implantation ( TAVI ) and is associated with increased risk for mortality .


The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI .


Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI .


Patients will be randomized in a 1:1 fashion to the RenalGuard system ( active group ) versus non-matched saline infusion ( sham-controlled group ) .


Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure .


The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI .


Clinicaltrials.gov : NCT01866800 , 30 April 30 2013 .


To compare the efficacies of non-bismuth quadruple therapy for 7 days versus standard triple therapy for 7 or 10 days in initial treatment of Helicobacter pylori ( H.pylori ) .


A randomized , open-labeled , controlled trial comparing non-bismuth quadruple therapy with standard triple therapy was performed at Peking University First Hospital from August 2010 to July 2012 .


A total of 246 patients with a diagnosis of H.pylori infection by ( 13 ) C-urea breath test and receiving no eradication therapy were randomly divided into non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days .


There were 110 males and 136 females with an age range of 18-75 years .


Among them , 81 patients received non-bismuth quadruple therapy ( esomeprazole 20 mg , amoxicillin 1 000 mg , clarithromycin 500 mg and tinidazole 500 mg given twice daily for 7 days ) ; 82 standard triple therapy ( esomeprazole 20 mg , amoxicillin 1 000 mg and clarithromycin 500 mg given twice daily ) for 7 days and 83 standard triple therapy for 10 days .


The efficacies were examined at Week 4 post-therapy by ( 13 ) C-urea breath test .


The incidence of adverse drug reactions was recorded .


Among them , 242 patients completed the follow-up .


The eradication rates for non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days were 91.4 % ( 74/81 ) , 79.3 % ( 65/82 ) and 79.5 % ( 66/83 ) as determined by intention-to-treat analysis ( ITT ) .


The eradication rates were 92.5 % ( 74/80 ) , 81.3 % ( 65/80 ) and 80.5 % ( 66/82 ) respectively as determined by per-protocol analysis ( PP ) .


Non-bismuth quadruple therapy was superior to standard triple therapy for 7 days ( ITT analysis P = 0.029 , PP analysis P = 0.035 ) and 10 days ( ITT analysis P = 0.032 , PP analysis P = 0.026 ) .


The differences for the eradication rates between standard triple therapy for 7 days and for 10 days were insignificant ( ITT analysis P = 0.968 , PP analysis P = 0.902 ) : Adverse reaction rates for non-bismuth quadruple therapy ( 8.8 % , 7/80 ) and standard triple therapy for 7 days ( 7.5 % , 6/80 ) and 10 days ( 9.8 % , 8/82 ) were not significantly different ( P = 0.872 ) .


Non-bismuth quadruple therapy for 7 days is both effective and safe for the first-line eradication of H.pylori .


The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen ( CLEAR-ER ) trial demonstrated safety of recombinant tissue-type plasminogen activator ( r-tPA ) plus eptifibatide in acute ischemic stroke ( AIS ) .


CLEAR-ER randomized AIS patients ( 5:1 ) to 0.6 mg/kg r-tPA plus eptifibatide versus standard r-tPA ( 0.9 mg/kg ) .


Interventional Management of Stroke III randomized AIS patients to r-tPA plus endovascular therapy versus standard r-tPA .


Albumin in Acute Stroke Part 2 randomized patients to albuminr-tPA versus saliner-tPA .


Our aim was to compare outcomes in CLEAR-ER combination arm patients to propensity score-matched r-tPA only subjects in Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III .


The primary outcome was 90-day severity-adjusted modified Rankin score ( mRS ) dichotomization based on baseline National Institutes of Health Stroke Scale .


Secondary outcomes were 90-day mRS dichotomization as excellent ( mRS , 0-1 ) ; mRS dichotomization as favorable ( mRS , 0-2 ) ; and nonparametric analysis of the ordinal mRS.


Eighty-five combination arm CLEAR-ER subjects were matched with 169 Albumin in Acute Stroke Part 2 and Interventional Management of Stroke III trials ' r-tPA only patients ( controls ) .


Median age in CLEAR-ER and control subjects was 68years ; median National Institutes of Health Stroke Scale in the CLEAR-ER subjects was 11 and in control subjects 12 .


At 90 days , CLEAR-ER subjects had a nonsignificantly greater proportion of patients with favorable outcomes ( 45 % versus 36 % ; unadjusted relative risks , 1.24 ; 95 % confidence intervals , 0.91-1 .69 ; P = 0.18 ) .


Secondary outcomes were 52 % versus 34 % excellent outcomes ( relative risks , 1.51 ; 95 % confidence intervals , 1.13-2 .02 ; P = 0.007 ) ; 60 % versus 53 % favorable outcome ( relative risks , 1.13 ; 95 % confidence intervals , 0.90-1 .41 ; P = 0.31 ) ; and ordinal Cochran-Mantel-Haenszel P = 0.10 .


r-tPA plus eptifibatide showed a favorable direction of effect that was consistent across multiple approaches for AIS outcome evaluation .


A phase III trial to establish the efficacy of r-tPA plus eptifibatide for improving AIS outcomes is warranted .


A randomized prospective study .


The study included 87 children aged from 5 to 18 , ASA I-II .


The patients were divided into two groups .


We assessed the impact of reamberin 1.5 % ( succinate-containing infusion solution ) on the level of metabolism and recovery after surgery in patients of main group ( n = 44 ) and control group ( n = 43 ) during different surgeries .


All patients received general anaesthesia with sevoflurane , fentanyl , and rocuronium .


Reamberin 1.5 % promotes to increase the level of basal metabolism in the early postoperative period , decreases the duration of awakening periods , improves recovery of motor activity and adequate breathing .


It is difficult to choose the correct fertility treatment in women with poor ovarian reserve .


Although various methods have been used , the management of controlled ovarian hyperstimulation is not easy in poor responders .


The aim of this study was to evaluate the efficacy of dehydroepiandrosterone ( DHEA ) on in vitro fertilization-intracytoplasmic sperm injection ( IVF-ICSI ) outcome of poor responders .


This was a randomized , prospective controlled trial .


Women with serum antimullerian hormone < 1 ng/ml or serum follicle-stimulating hormone > 15 IU/l and antral follicle count < 4 on day 2 of the menstrual cycle were considered to have poor ovarian reserve .


All women were treated with a microdose induction protocol .


Women in the study group received IVF-ICSI and DHEA 75 mg daily for 12 weeks .


Women in the control group received IVF-ICSI without DHEA supplementation .


In total , 208 women with diminished ovarian reserve was enrolled in the study , 104 in the study group and 104 in the control group .


The number of oocytes retrieved and the fertilization rate were slightly higher in the study group , but the pregnancy rate was higher in the control group .


The differences were not significant .


The results failed to show that DHEA supplementation enhances IVF-ICSI outcome in women with poor ovarian reserve .


Ischemic preconditioning ( IPC ) and anesthetic preconditioning ( APC ) have been reported to attenuate ischemia-reperfusion ( IR ) injury after liver resection under continuous inflow occlusion .


This study evaluates whether these strategies enhance hepatic protection of remnant liver against IR after liver resection with intermittent clamping ( INT ) .


A total of 106 patients without underlying liver disease and submitted to liver resection using INT were randomized into 3 groups : IPC ( 10 minutes of inflow occlusion followed by 10 minutes of reperfusion before liver transection ) , APC ( sevoflurane administration for 20 minutes before liver transection ) , and INT ( no preconditioning ) .


Patients were also stratified according to the extent of the hepatectomy .


Cytoprotection was evaluated by comparing hepatocyte and endothelial dysfunction markers , apoptosis , histologic lesions , and postoperative outcome .


No differences were observed in preoperative chemotherapy and steatosis , total warm ischemia time , operative time , or blood loss .


Kinetics of transaminases ( aspartate aminotransferase , P = .137 ; alanine aminotransferase , P = .616 ) , bilirubin ( P = .980 ) , and hyaluronic acid increase ( P = .514 ) revealed no differences .


Significant apoptosis was present in 40 % of patients , mild-to-moderate leukocyte infiltration and steatosis in 45 % and 55 % , respectively , and mild sinusoidal congestion in 65 % , with a similar distribution in the 3 groups .


When patients were stratified by major versus minor resections , no differences were observed in any of the variables studied .


Postoperative clinical outcomes were also similar .


These results suggest that these protocols of IPC and APC used in this study do not provide better cytoprotection from IR when INT is used .


The effects of the use of the stapler or hand-sewn method in oesophagogastric anastomosis on postoperative morbidity , mortality and quality of life after oesophagectomy remain controversial .


The purpose of his study was to compare clinical outcomes of hand-sewn and stapler techniques in oesophagogastric anastomosis after oesophagectomy for oesophageal carcinoma .


We performed a prospective randomized controlled trial on 478 patients treated for oesophageal tumour between February 2009 and December 2011 .


Patients were randomly assigned to two treatment groups with 237 patients in the hand-sewn group and 241 patients in the circular stapler group ( http://www.chictr.org: ChiCTR-TRC-13004428 ) .


The mean follow-up time was 18 months .


The mean operating time of the stapled group and the hand-sewn group were 193 and 226 min , respectively ( P < 0.001 ) .


Seventeen clinical and radiological leakages occurred in the hand-sewn group compared with 7 in the stapler group ( P = 0.033 ) .


In the stapler group hospital mortality occurred in 10 patients ( 4.3 % ) and in the hand-sewn group in 9 patients ( 3.9 % ) ( P = 0.837 ) .


Anastomotic strictures were noted in 31 patients from the stapler group ( 14.2 % ) and in 16 patients from the hand-sewn group ( 7.5 % ) ( P = 0.027 ) .


Using the circular stapler method in oesophagogastric anastomoses had a lower anastomotic leakage rate and shorter operating time compared with the hand-sewn method .


However , the circular stapler method was associated with a significantly increased risk of anastomotic strictures .


To evaluate the long-term efficacy and safety of certolizumab pegol ( CZP ) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis ( RA ) patients with an inadequate response to methotrexate .


J-RAPID double-blind patients were entered into an open-label extension ( OLE ) study .


Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology ( ACR ) 20 response received CZP 200 mg every other week ( Q2W ) plus methotrexate .


Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate .


The ACR20/ACR50/ACR70 response rates of double-blind completers ( n = 204 ) were 89.7 % / 67.2 % / 36.3 % at OLE entry and 95.6 % / 84.8 % / 58.3 % at 52 weeks , respectively .


Other clinical , functional and radiographic outcomes were sustained with long-term CZP plus methotrexate .


Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed .


The efficacy and safety of CZP treatment were similar between the two dosing schedules .


Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients .