From the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) , 801 patients with an implanted CRT-defibrillator device with data available on biventricular pacing percentage and pre-implantation 24-h Holter recordings were included .


Using logistic regression , we estimated the influence of ectopic beats on the percentage of biventricular pacing .


Reverse remodeling was measured as reductions in atrial and left ventricular end-systolic volumes ( LVESV ) at 1 year .


Cox models were used to assess the influence of ectopic beats on the outcomes of heart failure ( HF ) or death , ventricular tachyarrhythmias ( VTAs ) , and death .


In the pre-implantation Holter recording , ectopic beats accounted for a mean 3.2 5.5 % of all beats .


The probability of subsequent low biventricular pacing percentage ( < 97 % ) was increased 3-fold ( odds ratio : 3.37 ; 95 % confidence interval : 1.74 to 6.50 ; p < 0.001 ) in patients with 0.1 % to 1.5 % ectopic beats and 13-fold ( odds ratio : 13.42 ; 95 % confidence interval : 7.02 to 25.66 ; p < 0.001 ) in patients with > 1.5 % ectopic beats compared with those with < 0.1 % ectopic beats .


Patients with 0.1 % ectopic beats had significantly less reverse remodeling ( percent reduction in LVESV 31 15 % ) than patients with < 0.1 % ectopic beats ( percent reduction in LVESV 39 14 % ; p < 0.001 ) .


The risk of HF/death and VTA was increased significantly in those with 0.1 % to 1.5 % ectopic beats ( hazard ratio : 3.13 and 1.84 , respectively ) and for > 1.5 % ectopic beats ( hazard ratio : 2.38 and 2.74 , respectively ) .


Relatively low frequencies of ectopic beats ( 0.1 % ) dramatically increase the probability of low biventricular pacing ( < 97 % ) , with reduced CRT efficacy by less reverse remodeling and higher risk of HF/death and VTA .


This supports pre-implantation Holter monitoring of patients selected for CRT for optimal outcome .


( MADIT-CRT : Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy ; NCT00180271 ) .


Indacaterol 75 g once daily is a long-acting 2 agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease ( COPD ) .


The purpose of this study was to evaluate patients ' perception of onset of effect with a single dose .


In this double-blind , crossover , Phase IV study , 40 patients were randomized to receive a single dose of indacaterol 75 g or placebo via a dry powder inhaler device .


The primary variable was time until patient 's perception of onset of effect , using a simple self-administered ( nonvalidated ) questionnaire that patients answered at nine protocol-specified time points .


Exploratory variables included change in forced expiratory volume in 1 second ( FEV1 ) and change in percent predicted FEV1 from predose to postdose ( determined 60-75 minutes postdose ) .


The least-squares mean time to patient 's perception of onset of effect was 25.4 minutes and 23.9 minutes for indacaterol and placebo , respectively .


There was no significant effect for treatment , period , or sequence on the time to patient 's perception .


In addition , no statistically significant differences between treatments were observed for patient 's global satisfaction with onset of effect and global expectation of treatment adherence .


For the exploratory variable change in FEV1 from predose to postdose , indacaterol showed superiority over placebo with a clinically relevant least-squares mean treatment difference of 0.12 L ( P < 0.0001 ) .


There was little or no association between patient 's perception of time to onset of effect and change in FEV1 , or change in percent predicted FEV1 .


Both treatments were well tolerated .


A single dose of indacaterol 75 g did not separate from placebo in terms of patient perception of onset , although there was an improvement in FEV1 for indacaterol compared with placebo .


Development and use of a validated questionnaire may be needed to address the inconsistency in evaluating this patient-related outcome .


Injectable bulking treatment for fecal incontinence ( FI ) is intended to expand tissue in the anal canal and prevent fecal leakage .


Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity .


This study evaluated the long-term ( 36-month ) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer ( NASHA Dx ) on FI symptoms .


In a prospective multicenter trial , 136 patients with FI received the NASHA Dx bulking agent .


Treatment success defined as a reduction in number of FI episodes by 50 % or more compared with baseline ( Responder50 ) .


Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score ( CCFIS ) and Fecal Incontinence Quality of Life Scale ( FIQL ) , and adverse events were also evaluated .


Successful decrease in symptoms was achieved in 52 % of patients at 6months and this was sustained at 12months ( 57 % ) and 36months ( 52 % ) .


Mean CCFIS decreased from 14 at baseline to 11 at 36months ( p < 0.001 ) .


Quality-of-life scores for all four domains improved significantly between baseline and 36months of follow-up .


Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort .


Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3years .


We sought to examine the prevalence of EEG abnormalities in Smith-Lemli-Opitz syndrome ( SLOS ) as well as the relationship between interictal epileptiform discharges ( IEDs ) and within-subject variations in attentional symptom severity .


In the context of a clinical trial for SLOS , we performed cross-sectional and repeated-measure observational studies of the relationship between EEG findings and cognitive/behavioral factors on 23 children ( aged 4-17 years ) .


EEGs were reviewed for clinical abnormalities , including IEDs , by readers blinded to participants ' behavioral symptoms .


Between-group differences in baseline characteristics of participants with and without IEDs were analyzed .


Within-subject analyses examined the association between the presence of IEDs and changes in attention-deficit/hyperactivity disorder ( ADHD ) symptoms .


Of 85 EEGs , 43 ( 51 % ) were abnormal , predominantly because of IEDs .


Only one subject had documented clinical seizures .


IEDs clustered in 13 subjects ( 57 % ) , whereas 9 subjects ( 39 % ) had EEGs consistently free of IEDs .


While there were no significant group differences in sex , age , intellectual disability , language level , or baseline ADHD symptoms , autistic symptoms tended to be more prevalent in the `` IED '' group ( according to Autism Diagnostic Observation Schedule-2 criteria ) .


Within individuals , the presence of IEDs on a particular EEG predicted , on average , a 27 % increase in ADHD symptom severity .


Epileptiform discharges are common in SLOS , despite a relatively low prevalence of epilepsy .


Fluctuations in the presence of epileptiform discharges within individual children with a developmental disability syndrome may be associated with fluctuations in ADHD symptomatology , even in the absence of clinical seizures .


To describe the effectiveness , reach and implementation of a weight gain prevention intervention among public school employees .


A multi-level intervention was tested in a cluster randomized trial among 782 employees in 12 central Massachusetts public high schools from 2009 to 2012 .


The intervention targeted the nutrition and physical activity environment and policies , the social environment and individual knowledge , attitudes and skills .


The intervention was compared to a materials only condition .


The primary outcome measures were change in weight and body mass index ( BMI ) at 24-month follow-up .


Implementation of physical environment , policy and social environment strategies at the school and interpersonal levels , and intervention participation at the individual level were assessed .


At 24-month follow-up , there was a net change ( difference of the difference ) of -3.03 pounds ( p = .04 ) and of -.48 BMI units ( p = .05 ) between intervention and comparison conditions .


The majority of intervention strategies were successfully implemented by all intervention schools , although establishing formal policies was challenging .


Employee participation in programs targeting the physical and social environment was maintained over time .


This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees .


It is important to engage patients and surrogates in conversations about goals and preferences for medical treatment before high-risk surgery .


However , few interventions have been tested to facilitate these discussions .


To assess the acceptability and feasibility of a facilitated , structured conversation with patients and surrogates about patient goals and preferences for medical treatment during their visit to a preoperative testing center before high-risk surgery .


A randomized controlled pilot study in the preoperative testing center at a tertiary academic hospital over a 4-month period .


We used baseline and preoperative surveys to assess feasibility , and to compare differences in worry , surrogate burden , and patient-surrogate concordance about treatment preferences in conversation and control groups .


We assessed acceptability of the conversation qualitatively and through surveys .


Of 146 eligible patients , 79 were approached , and 65 declined to participate .


Thirteen completed the study and 8 were randomized to the structured conversation .


Major recruitment barriers included lack of time , or surrogate unavailability .


Most postconversation patients were less worried , and more hopeful for a good recovery before surgery ; 7 of 8 would recommend the conversation .


Six of 8 surrogates reported postoperatively that the conversation helped prepare them to be a surrogate .


Concordance improved in the intervention group only .


Current processes of care present major barriers to conducting facilitated conversations in the preoperative testing center .


Among a small group of patients and surrogates , most found a structured conversation about the patient 's goals and preferences for medical treatment helpful before high-risk surgery .


Transradial approach catheterization is now widely used in coronary angiography and angioplasty .


The ulnar artery , which is one of the two terminal branches of the brachial artery , may be a potential approach for cardiac catheterization .


The aim of this study was to evaluate the safety and feasibility of a transulnar approach for coronary catheterization in non-selective patients .


A total of 535 consecutive patients were randomly assigned to transulnar approach ( TUA ) group ( n = 271 ) or transradial approach ( TRA ) group ( n = 264 ) upon arrival at the catheterization laboratory .


Allen 's test and inverse Allen 's test were not routinely performed .


Ultrasound-Doppler assessment of the forearm artery was performed before the procedure , two days after the procedure , and 30 days after the procedure .


The primary endpoints of study were the rate of successful artery cannulation and the access-site related complications .


The secondary endpoints included the number of needle punctures , total time for the procedure , and major adverse cardiac events ( MACE ) .


Successful puncture of the objective artery was obtained in 91.5 % of the patients in the TUA group , and 95.1 % of the patients in the TRA group ( P > 0.05 ) .


There was no significant difference in hematoma complications between the two groups ( 7.7 % vs. 4.2 % , P = 0.100 ) .


A motor abnormality of the hand was observed in one patient in the TUA group .


There were no arteriovenous fistula or pseudoaneurysm observed in our study .


Three ( 1.1 % ) patients in the TUA group and 8 ( 3.0 % ) patients in the TRA group had occlusion of the access artery ( P = 0.137 ) , but none of the patients had symptoms or signs of hand ischemia .


There were no significant differences in MACE between the two groups during follow-up .


The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients .


To evaluate the feasibility of a 100 kVp tube voltage combined with an iterative reconstruction algorithm in retrospective electrocardiogram ( ECG ) - gated thoracoabdominal aortic CT angiography ( CTA ) .


Ninety-eight patients who underwent clinically indicated thoracoabdominal aortic CTA were randomly assigned to two groups : group A ( n = 50 ) were scanned to 120 kVp and group B ( n = 48 ) to 100 kVp .


The body mass index of all included patients was < 25 kg/m ( 2 ) .


Group A scans were reconstructed with a standard filtered back projection ( FBP ) algorithm , and group B scans with FBP , iDose , and non-tagged algorithms .


Data comparison between groups was performed using t-test and analysis of variance .


Compared with group A , the iDose algorithm in group B yielded a higher contrast-to-noise ratio ( CNR ; 48.1 10.1 , p < 0.05 ) , a higher signal-to-noise ratio ( SNR ; 13.8 5.4 , p < 0.05 ) , and a lower standard deviation ( SD ; 30.3 6.9 , p < 0.05 ) .


The subjective score of iDose reconstructions from group B was significantly lower than that of FBP reconstruction from group A ( p < 0.05 ) .


In group B , the non-tagged algorithm resulted in a higher CNR and a higher SNR , but a higher SD and a higher subjective score than did the iDose algorithm .


The average effective dose for group B was 35.8 % lower than that for group A.


A combination of a 100 kVp tube voltage and the iDose algorithm can help to improve image quality and reduce radiation dose in retrospective ECG-gated thoracoabdominal aortic CTA .


The use of different limbs for the administration of sequential doses of an intradermal rabies vaccine was shown to result in reduced vaccine immunogenicity .


We aimed to assess whether this phenomenon also occurs with routine infant vaccines .


In this open-label , randomised , controlled study , eligible healthy infants 6-12 weeks of age recruited through five clinical trials units ( four in the UK and one in Malta ) were randomly assigned in a 1:1 ratio to two vaccination groups : consistent limb or alternating limb .


Infants in the consistent limb group received the diphtheria-tetanus-acellular pertussis-inactived polio-Haemophilus influenzae type b combined vaccine ( DTaP-IPV-Hib ) at 2 , 3 , and 4 months of age , and the pneumococcal conjugate vaccine ( PCV13 ) at 2 , 4 , and 12 months , all administered to the right leg .


Infants in the alternating limb group received DTaP-IPV-Hib in the left leg at 2 months and in the right leg at 3 and 4 months ; and PCV13 in the left leg at 2 months , in the right leg at 4 months , and in the left arm at 12 months .


All infants in both groups received the combined H influenzae type b and capsular group C Neisseria meningitidis tetanus toxoid conjugate vaccine ( Hib-MenC-TT ) , administered in the left leg at 12 months .


Randomisation was achieved by randomly generated codes , with permuted block size of 30 , and was stratified by study site .


Group allocation was not masked from study staff and parents of participants after enrolment , but group allocation was masked from laboratory staff assessing blood samples .


The current study was a prespecified secondary objective of a parent phase 4 trial that assessed the induction of immunity following varying schedules of vaccination with glyco-conjugate capsular group C Neisseria meningitidis ( Men C ) vaccines in infancy .


The objective of the current study was to compare the immunogenicity and reactogenicity of vaccines delivered in either consistent or alternating limbs .


Immunogenicity was assessed by comparing serum IgG geometric mean concentrations at 5 , 12 , 13 , and 24 months , analysed per protocol .


This study is registered with ClinicalTrials.gov , number NCT01129518 .


Between July 5 , 2010 , and Aug 1 , 2013 , we enrolled 509 infants and randomly allocated them to the consistent limb group ( n = 254 ) or the alternating limb group ( n = 255 ) .


Anti-H influenzae type b anti-polyribosylribitol phosphate IgG geometric mean concentrations were lower in the consistent limb group than in the alternating limb group at 5 months ( consistent limb 041 g/mL [ 95 % CI 031-054 ] vs alternating limb 061 g/mL [ 045-082 ] ; p = 00268 ) and at 12 months ( 035 g/mL [ 028-043 ] vs 050 g/mL [ 040-062 ] ; p = 00136 ) .


Anti-tetanus toxoid antibody IgG geometric mean concentrations were lower in the consistent limb group ( 163 IU/mL [ 95 % CI 140-190 ] ) than in the alternating limb group ( 230 IU/mL [ 197-268 ] ) at 13 months ( p = 00008 ) and at 24 months ( 044 IU/mL [ 037-052 ] vs 061 IU/mL [ 051-073 ] ; p = 00074 ) .


Anti-pneumococcal IgG geometric mean concentrations were similar between both groups at all timepoints .


The proportions of participants who had adverse events did not differ between the two groups .


Use of different ( alternating ) limbs for sequential doses of routine infant vaccines does not reduce , and might enhance , immunogenicity .


The underlying mechanism for this finding warrants further research .


NIHR Oxford Biomedical Research Centre and GlaxoSmithKline Biologicals .


Most minor hand operations can be performed with local anesthesia and tourniquet .


Some literature supports this concept based on the believe that the `` patient can tolerate it '' .


Nowadays , the wide-awake technique with epinephrine - contained lidocaine is safe .


This technique does not need a tourniquet because epinephrine provides local vasoconstriction .


The present study was designed to compare patients ' comfort and effectiveness of local anesthesia as well as bleeding at the surgical site between wide-awake anesthesia and local lidocaine with tourniquet application .


Prospective Clinical Trial was performed in 60 patients who received outpatient surgery for common hand problems at Maharaj Nakorn Chiang Mai Hospital .


With randomization , 30 patients were in wide-awake group , who received adrenaline-contained lidocaine as a local anesthetic agent , with tourniquet wrapping but with no pressure applied ( group 1 ) .


The other 30 patients were in the conventional group that received lidocaine ( no adrenaline ) and a 250-mmHg tourniquet application ( group 2 ) .


Operations were performed with standard methods .


Visual analog scores , surgical field bleeding , amount of bleeding , any complications within 4 weeks were recorded .


There are no significant differences between the two groups in terms of patient profiles ( sex , age and diseases ) , injected site pain and surgeon 's opinion of surgical site bleeding .


Tourniquet 's pain and the amount of blood loss in the conventional group were significantly higher than the wide-awake group .


Wide-awake technique ( no tourniquet applied ) offers better comfort for patients and less total blood loss while providing effective anesthesia and patient safety as with the conventional technique .


To evaluate if the intake of a fluoridated food supplement in breastfeeding mothers increases the fluoride concentration in breast milk .


A double-blind randomized placebo-controlled study was designed .


Two groups of women were formed : a fluoride group ( n = 112 ) , using a non-sucrose food supplement containing fluoride ( 1,500 g/l for each dose ) and a control group ( n = 116 ) , using a non-sucrose food supplement without fluoride content .


The women were followed for 6 weeks .


Samples of breast milk were collected and analyzed using an ion-specific electrode .


85 women in the fluoride group and 83 in the control group concluded the trial .


Fluoride concentrations in the two groups were statistically significantly different ( 515 g/l in the fluoride and 476 g/l in the control group P = 0.04 ) at the end of the experimental period .


In the fluoride group , a statistically significant increment in fluoride concentration during the experimental period was also observed ( from 468 104 g/l to 515 105 g/l ) .


The use of a non-sucrose food supplement containing fluoride resulted in a significant increment in fluoride concentration in breast milk .


Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited .


Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health .


The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas .


A cluster randomised control trial will be conducted , with schools as the unit of randomisation .


Initially , 32 secondary schools will be randomly allocated to a control or intervention group ( 12 control and 20 intervention ) .


An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools .


A survey of students in Grade 7 in both intervention and control schools will be conducted ( baseline ) and repeated three years later when the students are in Grade 10 .


The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems .


At follow-up , the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness .


The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools .


The outcomes of the trial are of importance to youth , schools , mental health clinicians and policymakers .


Australian New Zealand Clinical Trials Registry , ACTRN12611000606987 , registered 14 June 2011 .


Seroma formation , the most prevalent postoperative complication after mastectomy , is an inflammatory process that is potentially preventable via local steroid administration .


This study investigated the effect of local steroid administration on seroma formation .


This was a double-blind randomized placebo-controlled intervention study of a single dose of 80 mg methylprednisolone versus saline on seroma formation after mastectomy .


Patients were further classified according to the surgical axillary procedure : mastectomy with sentinel lymph node biopsy ( M + SLNB ) or mastectomy with level I-II axillary lymph node dissection ( M + ALND ) .


Treatments were administered into the wound cavity via the drain orifice following removal of the drain on the first day after surgery .


The primary endpoint was seroma formation ; secondary endpoints included the frequency of side-effects and complications .


A total of 212 women scheduled for mastectomy for primary breast cancer were included .


After M + SLNB , 32 ( 46 per cent ) of 69 women developed a seroma in the methylprednisolone group , compared with 52 ( 78 per cent ) of 67 in the saline group ( P < 0.001 ) .


The mean cumulative seroma volume in the intention-to-treat population for the first 10 and 30 days was significantly lower in the methylprednisolone group ( 24 ml versus 127 ml in the saline group , and 177 versus 328 ml respectively ) ( P < 0.001 ) .


After M + ALND , similar proportions of patients developed a seroma in the methylprednisolone ( 35 of 37 , 95 per cent ) and saline ( 34 of 36 , 94 per cent ) groups , and methylprednisolone administration had no significant effect on seroma formation .


No differences in infection rate were observed .


Methylprednisolone administered into the wound cavity on the first day after M + SLNB exerted a highly significant preventive effect against seroma formation during the next 30 days .


This effect was not seen in the M + ALND group .


Future studies may clarify whether higher or repeated methylprednisolone doses increase the efficacy .


To test the effects of pressure-controlled ( PCV ) and volume-controlled ( VCV ) ventilation during one-lung ventilation ( OLV ) for thoracic surgery on right ventricular ( RV ) function .


A prospective , randomized , double-blind , controlled , crossover study .


A single university hospital .


Fourteen pairs of consecutive patients scheduled for elective thoracotomy .


Patients were assigned randomly to ventilate the dependent lung with PCV or VCV mode , each in a randomized crossover order using tidal volume of 6 mL/kg , I : E ratio 1 : 2.5 , positive end-expiratory pressure ( PEEP ) of 5 cm H2O and respiratory rate adjusted to maintain normocapnia .


Intraoperative changes in RV function ( systolic and early diastolic tricuspid annular velocity ( TAV ) , end-systolic volume ( ESV ) , end-diastolic volume ( EDV ) and fractional area changes ( FAC ) ) , airway pressures , compliance and oxygenation index were recorded .


The use of PCV during OLV resulted in faster systolic ( 10.12.39 vs. 5.81.67 cm/s , respectively ) , diastolic TAV ( 9.21.99 vs. 4.61.42 cm/s , respectively ) ( p < 0.001 ) and compliance and lower ESV , EDV and airway pressures ( p < 0.05 ) than during the use of VCV .


Oxygenation indices were similar during the use of VCV and PCV .


The use of PCV offers more improved RV function than the use of VCV during OLV for open thoracotomy .


These results apply specifically to younger patients with good ventricular and pulmonary functions .


Middle molecular weight uraemic toxins are considered to play an important role in vascular dysfunction and cardiovascular outcomes in end-stage renal disease ( ESRD ) patients .


Recent dialysis techniques based on convection , specifically high-efficiency on-line haemodiafiltration ( HDF ) , enhance the removal of middle molecular weight toxins and reduce all-cause mortality in haemodialysis ( HD ) patients .


However , the mechanisms of these improved outcomes remain to be established .


This prospective study randomly assigned 42 ESRD patients to switch from high-flux HD to high-efficiency on-line HDF ( n = 22 ) or to continue HD ( n = 20 ) .


Brachial artery endothelium-dependent flow-mediated dilatation , central pulse pressure , carotid artery intima-media thickness ( IMT ) , internal diastolic diameter and distensibility and circulating markers of uraemia , inflammation and oxidative stress were blindly assessed before and after a 4-month follow-up .


Brachial flow-mediated dilatation and carotid artery distensibility increased significantly in the HDF group compared with HD , while carotid IMT and diameter remained similar .


HDF decreased predialysis levels of the uraemic toxins 2-microglobulin , phosphate and blood TNF mRNA expression .


Oxidative stress markers were not different between the HD and HDF groups .


Blood mRNA expression of protein kinase C 2 , an endothelial NO-synthase ( eNOS ) inhibitor , decreased significantly with HDF .


High-efficiency on-line HDF prevents the endothelial dysfunction and stiffening of the conduit arteries in ESRD patients compared with high-flux HD .


HDF decreases uraemic toxins , vascular inflammation , and is associated with subsequent improvement in eNOS functionality .


These results suggest that reduced endothelial dysfunction may be an intermediate mechanism explaining the beneficial outcomes associated with HDF .


Anatomic double-bundle anterior cruciate ligament ( ACL ) reconstruction provides excellent results for restoring normal kinematics to the knee .


Nevertheless , strong evidence supporting an ideal method for fixation of the ACL graft is lacking .


Intratunnel femoral fixation of the ACL graft via a cross-pin fixation technique would provide better clinical and objective results than the extratunnel femoral fixation with cortical buttons .


Randomized clinical trial ; Level of evidence , 2 .


Seventy patients with a unilateral ACL-deficient knee were randomly assigned to 1 of 2 femoral fixation groups .


Group A ( 35 patients ) was fixed with 2 bioabsorbable Rigidfix pins , 1 cross-pin per bundle , while group B ( 35 patients ) was secured with 1 EndoButton cortical button per bundle .


All femoral tunnels were created via an anteromedial portal , and a bioabsorbable Biointrafix interference screw was used for tibial fixation for both groups .


The evaluation of the patients was performed by history details , clinical examination findings , measurement of the joint laxity by KT-1000 arthrometer , and use of validated patient outcome questionnaires .


Statistical analysis was carried out with Fisher exact and Mann-Whitney U tests , with P < .05 considered the cutoff level of significance .


At a mean follow-up of 30 months , 34 and 32 patients of group A and B , respectively , were available for evaluation .


There were no statistically significant differences between the treatment groups regarding the subjective and objective outcomes , except for KT-1000 arthrometer values .


The median KT-1000 value of patients in the cross-pin fixation group was 1.30 mm , while the median value in the cortical button fixation group was 1.95 mm ( P < .001 ) .


Four patients with ACL grafts that were fixed with cortical buttons demonstrated failure of stability via the instrumented knee laxity testing , while patients from the other group had no failures .


Intratunnel femoral fixation of the double-bundle ACL graft from the cross-pin fixation technique provided better instrumented knee laxity results than did the extratunnel femoral fixation with cortical buttons .


Future larger studies comparing these 2 techniques should be conducted to ensure the availability of stronger evidence supporting the findings of this study .


To compare results of obese patients with knee osteoarthritis ( OA ) who , after an intensive weight loss regimen , received 1 year of either dietary support ( D ) , a knee-exercise program ( E ) , or `` no attention '' ( C ; control group ) .


We conducted a randomized , 2-phase , parallel-group trial .


A total of 192 obese participants with knee OA were enrolled ; the mean age was 62.5 years and 81 % were women with a mean entry weight of 103.2 kg .


In phase 1 , all participants were randomly assigned to 1 of 3 groups and began a dietary regimen of 400-810 and 1,250 kcal/day for 16 weeks ( 2 8-week phases ) to achieve a major weight loss .


Phase 2 consisted of 52 weeks ' maintenance in either group D , E , or C. Outcomes were changes from randomization in pain on a 100-mm visual analog scale , weight , and response according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria .


Mean weight loss for phase 1 was 12.8 kg .


After 1 year on maintenance therapy , the D group sustained a lower weight ( 11.0 kg , 95 % confidence interval [ 95 % CI ] 9.0 , 12.8 kg ) than those in the E ( 6.2 , 95 % CI 4.4 , 8.1 kg ) and C ( 8.2 , 95 % CI 6.4 , 10.1 kg ) groups ( P = 0.002 by analysis of covariance [ ANCOVA ] ) .


Adherence was low in the E group .


All groups had statistically significant pain reduction ( D : 6.1 ; E : 5.6 ; and C : 5.5 mm ) with no difference between groups ( P = 0.98 by ANCOVA ) .


In each group 32 ( 50 % ) , 26 ( 41 % ) , and 33 ( 52 % ) participants responded to treatment in the D , E , and C groups , respectively , with no statistically significant difference in the number of responders ( P = 0.41 ) .


A significant weight reduction with a 1-year maintenance program improves knee OA symptoms irrespective of maintenance program .


Perampanel , a selective , noncompetitive - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid ( AMPA ) glutamate receptor antagonist , is indicated for adjunctive treatment of partial seizures in patients 12years based on three phase III clinical studies .


The perampanel U.S. Prescribing Information includes a boxed warning for serious psychiatric and behavioral adverse reactions .


To provide context for this warning , detail on psychiatric and behavioral safety data from perampanel clinical studies is presented .


An analysis of pooled safety data from three phase III studies in patients with partial seizures is presented .


Data from phase I and phase II studies in patients with and without epilepsy were also analyzed .


Psychiatric and behavioral treatment-emergent adverse events ( TEAEs ) were evaluated according to Medical Dictionary for Regulatory Activities ( MedDRA ) terms , using `` narrow '' and `` narrow-and-broad '' standardized MedDRA queries ( SMQs ) for TEAEs suggestive of hostility/aggression .


From the three phase III partial-seizure studies , the overall rate of psychiatric TEAEs was higher in the 8mg ( 17.2 % ) and 12mg ( 22.4 % ) perampanel groups versus placebo ( 12.4 % ) .


In the `` narrow '' SMQ , hostility/aggression TEAEs were observed in 2.8 % for 8mg and 6.3 % for 12mg perampanel groups , versus 0.7 % of placebo patients .


`` Narrow-and-broad '' SMQs for hostility/aggression TEAE rates were 12.3 % for 8mg and 20.4 % for 12mg perampanel groups , versus 5.7 % for placebo ; rates for events resulting in discontinuation were perampanel = 1.6 % versus placebo = 0.7 % .


For events reported as serious AEs ( SAEs ) , rates were perampanel = 0.7 % versus placebo = 0.2 % .


In nonepilepsy patients , psychiatric TEAEs were similar between patients receiving perampanel and placebo .


In phase I subjects/volunteers , all psychiatric TEAEs were mild or moderate .


These analyses suggest that psychiatric adverse effects are associated with use of perampanel .


Patients and caregivers should be counseled regarding the potential risk of psychiatric and behavioral events with perampanel in patients with partial seizures ; patients should be monitored for these events during treatment , especially during titration and at higher doses .


Less than 50 % of patients experience sufficient pain relief with current drug therapy for neuropathic pain .


Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain .


In this randomized , double-blind , placebo-controlled clinical trial , patients with subacute lumbar radicular pain received placebo , amitriptyline 25 mg , or minocycline 100 mg once a day ( n = 20 per group ) for 14 days .


Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from 0 to 10 on days 7 and 14 .


Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire , consumption of rescue medication , and adverse events on days 7 and 14 .


Sixty patients were randomized and included in an intention-to-treat analysis .


After 14 days , patients in the minocycline and amitriptyline groups reported a reduction of 1.47 ( 95 % confidence interval , 0.16-2 .83 ; P = 0.035 ) and 1.41 ( 95 % confidence interval , 0.05-2 .78 ; P = 0.043 ) , respectively , in the numeric rating scale compared to the placebo group .


No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups .


The rate of adverse events in the amitriptyline group was 10 % versus none in the minocycline and placebo groups .


No differences were noted in the consumption of rescue medication .


Although both groups differed from placebo , their effect size was small and therefore not likely to be clinically meaningful .


This study investigated the role of the bone marrow-derived CD34 + cell in a milieu of osteoprogenitor cells , bone marrow plasma cell adhesion molecules , recombinant human bone morphogenetic protein ( rhBMP ) , and a matrix of crushed cancellous allogeneic bone in the clinical regeneration of functionally useful bone in craniomandibular reconstructions .


The history and current concepts of bone marrow hematopoietic stem cells and mesenchymal stem cells are reviewed as they relate to bone regeneration in large continuity defects of the mandible .


Patients with 6 - to 8-cm continuity defects of the mandible with retained proximal and distal segments were randomized into two groups .


Group A received an in situ tissue-engineered graft containing 54 38 CD34 + cells/mL along with 54 38 CD44 + , CD90 + , and CD105 + cells/mL together with rhBMP-2 in an absorbable collagen sponge ( 1 mg/cm of defect ) and crushed cancellous allogeneic bone .


Group B received the same graft , except the CD34 + cell concentration was 1,012 752 cells/mL .


The results were analyzed clinically , radiographic bone density was measured in Hounsfield units ( HU ) , and specimens were analyzed histomorphometrically .


Forty patients participated ( 22 men and 12 women ; mean age , 57 years ) .


Eight of 20 group A patients ( 40 % ) achieved the primary endpoint of mature bone regeneration , whereas all 20 group B patients ( 100 % ) achieved the primary endpoint .


CD34 + cell counts above 200/mL were associated with achievement of the primary endpoint .


Bone density was lower in group A ( 424 115 HU ) than in group B ( 731 98 HU ) .


Group A bone showed a mean trabecular bone area of 36 % 10 % , versus 67 % 13 % for group B.


The CD34 + cell functions as a central signaling cell to mesenchymal stem cells and osteoprogenitor cells in bone regeneration .


The mechanism of bone marrow-supported grafts requires a complete milieu to regenerate large quantities of functionally useful bone .


CD34 + cell counts in a concentration of at least 200/mL in composite grafts are directly correlated to clinically successful bone regeneration .


To determine the effect of nutritional supplementation on height , weight , and body mass index ( BMI ) in short and lean prepubertal children .


A prospective , randomized , double-blinded , placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy , lean , short , prepubertal children 3-9-years-old .


Anthropometry measurements were measured at 6 months .


Two hundred participants ( 149 boys ) entered the study and 171 ( 85.5 % ) completed the intervention period .


Baseline characteristics including age , sex , height-SDS , weight-SDS , BMI-SDS , and dietary caloric and protein intakes were similar in the formula and placebo groups .


` Good ' consumers ( intake of 50 % of the recommended dose ) in the formula group significantly improved height-SDS ( P < .001 ) and weight-SDS ( P = .005 ) with no change in BMI-SDS compared with ` poor ' consumers and the placebo group .


In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS ( r = 0.44 , P < .001 ) and weight-SDS ( r = 0.35 , P = .002 ) ; no significant correlations were found in the placebo group .


No serious adverse events were reported during the study .


Nutritional intervention with the formula was found to be a feasible , effective , and safe approach for promoting the physical growth of short and lean prepubertal children .


Methylated catechin , one of the active ingredients in green tea , has been reported to ameliorate allergic reactions .


We evaluated the efficacy of ` Benifuuki ' green tea , which contains O-methylated epigallocatechin-3-O - [ 3-O-methyl ] gallate ( O-methylated EGCG ) , in alleviating Japanese cedar pollinosis ( JCP ) .


The study was a double-blind , randomized , placebo-controlled trial .


The subjects with JCP were randomly assigned to drink 700ml of ` Benifuuki ' green tea containing O-methylated EGCG or ` Yabukita ' green tea ( not containing O-methylated EGCG ) as a placebo every day from December 2007 through March 2008 , which includes the pollen season .


The primary outcome was the area under the curve ( AUC ) of symptom scores during the peak pollen season .


Fifty-one adults with JCP participated in the study .


Twenty-six subjects were assigned to ` Benifuuki ' and 25 to ` Yabukita ' .


The AUC of symptom score during the peak pollen season in the ` Benifuuki ' group was significantly smaller than in the ` Yabukita ' group for each of runny nose , itchy eyes , tearing , total nasal symptom score , total ocular symptom score , nasal symptom-medication score and ocular symptom-medication score .


The total QOL-related questionnaire score for one week in the peak pollen season was significantly better in the ` Benifuuki ' group .


Increase in the peripheral eosinophil count in response to pollen exposure was suppressed in the ` Benifuuki ' group .


No adverse events were reported in either group .


` Benifuuki ' green tea containing a large amount of O-methylated EGCG reduced the symptoms of JCP and has potential as a complementary/alternative medicine for treating seasonal allergic rhinitis .


To observe the analgesic effect and safety of acupuncture-anesthetic composite anesthesia ( AACA ) in hysteroscopic surgery .


Totally 93 patients undergoing hysteroscopic surgery were randomly assigned to the intravenous anesthesia group ( A group , 30 cases ) , the AACA group ( B group , 32 cases ) , and the acupuncture combined with intravenous anesthesia group ( C group , 31 cases ) .


Patients in Group A were anesthetized by sufentanil combined propofol .


Those in Group B were anesthetized by sufentanil combined acupuncture .


Those in Group C were anesthetized by sufentanil , propofol combined acupuncture .


Yinlian and Ququan ( LR8 ) were needled for patients in Group B and C.


The peri-operative mean arterial pressure ( MAP ) , heart rate ( HR ) , and oxygen saturation ( SpO2 ) , the surgical time , the recovery time , the sufentanil and propofol dosages , adverse anesthesia reactions were observed .


Meanwhile , the OAA/S score , Ramsay sedation score , and Visual Analogue Score ( VAS ) were also measured .


Compared with Group A and C , patients in Group B were awake , with obvious increased OAA/S score ( P < 0.01 ) .


Ramsay sedation score was significantly lower ( P < 0.01 ) .


The MAP and HR were elevated ( P < 0.05 ) .


The patient case of SpO2 less than 85 % during the operation decreased ( P < 0.05 ) .


The incidence of postoperative dizziness was reduced ( P < 0.05 ) .


Compared with Group A , the propofol consumption decreased in Group C ( P < 0.05 ) .


There was no statistical difference in the operation time , the sufentanil dosage , VAS score , the incidence of postoperative nause - a and vomiting among the three groups ( P > 0.05 ) .


The patients were awake in AACA .


The intraoperative sedation was better than that obtained by intravenous anesthesia .


But the analgesic effect was similar to that obtained by intravenous anesthesia .


Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead .


However , dementia remains underdetected and suboptimally managed in general practice .


Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia .


The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design , with two arms : usual/normal care control versus educational intervention .


The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year .


Case identification was a secondary outcome measure .


23 practices in South-East England participated .


A total of 1,072 patients with dementia ( intervention : 512 , control : 560 ) had information in their medical records showing the number of reviews within 12 months ( or a proportion of ) before intervention or randomization and within 12 months ( or a proportion of ) after .


The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 ( SD 1.09 ; minimum 0 ; median 1 ; maximum 8 ) compared with 0.89 ( SD 0.92 ; minimum 0 ; median 1 ; maximum 4 ) before intervention .


In the control group prior to randomization the mean total number of dementia management reviews was 1.66 ( SD 1.87 ; minimum 0 ; median 1 ; maximum 12 ) and in the period after randomization it was 1.56 ( SD 1.79 ; minimum 0 ; median 1 ; maximum 11 ) .


Case detection rates were unaffected .


The estimated incidence rate ratio for intervention versus control group was 1.03 ( P = 0.927 , 95 % CI 0.57 to 1.86 ) .


The trial was timely , coinciding with financial incentives for dementia management in general practice ( through the Quality Outcomes Framework ) ; legal imperatives ( in the form of the Mental Capacity Act 2005 ) ; policy pressure ( The National Dementia Strategy 2009 ) ; and new resources ( such as dementia advisors ) that increased the salience of dementia for general practitioners .


Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices , nor did it increase case identification .


NCT00866099/Clinical Trials .


The objective of the Japan Strategic Anti-cancer Randomized Trial was to verify the efficacy of the use of ultrasonography in breast cancer screening among women aged 40-49 years .


The purpose of this paper was to report the design and recruitment result of this study .


In this study of women in their 40s , the participants were divided into two groups , one of which ( the intervention group ) was subjected to mammography and ultrasonography ( using a standardized ultrasonography examination ) , while the other ( the control group ) was examined with mammography , in a randomized controlled trial , with the objective of verifying the accuracy and efficacy of examinations by comparing the two groups .


The cumulative total number of participants registered in the study was 76 196 ( 38 313 in the intervention group and 37 883 in the control group ) .


71.0 % of participants registered to the study were under individual randomized controlled trial , 25.0 % were under cluster randomized controlled trial and 3.9 % were under non-randomized controlled group .


The study was designed so that participants registered at their first examination underwent examinations by the same method for the subsequent two years .


74.1 % of participants scheduled for a second examination had undertaken it , while information regarding the presence of interval cancer had been obtained from a further 20.6 % using a questionnaire .


At July 2013 , the status of 5.3 % of all participants was unclear .


It was the first large-scale randomized controlled trial carried out in Japan .


The scheduled second examinations were completed at the end of fiscal 2012 .


Once the proportion of participants whose status is unclear has fallen to 5 % , the authors plan to collate the data relating to the primary end points , and publish the results .


Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects .


The aim of this study was to develop and trial a short , simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating .


The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out .


Subjects were randomized into two treatment groups ( n = 10/group ) to receive either ferrous sulphate ( 200mg capsules containing 65mg of iron ) or placebo , both to be taken at mealtimes twice daily during the treatment period .


Subjects completed the questionnaires daily for 14days .


The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts ( i.e. nausea , vomiting , heartburn , abdominal pain , diarrhoea , and constipation ) .


Seventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group .


In the second week of the study ( i.e. wash-out ) , 67 % of the participants reporting one or more symptom ( s ) were in the ferrous sulphate group .


In the first week of the study ( treatment ) the number of symptoms reported by participants in the ferrous sulphate group ( meanSEM = 6.71.7 ) was significantly higher than that for participants in the placebo group ( 1.20.5 ) ( p = 0.01 ) .


In the second week of the study ( wash-out ) the number of symptoms reported by participants in the ferrous sulphate group ( 4.62.0 ) appeared higher than for participants in the placebo group ( 1.00.7 ) although this did not reach significance ( p = 0.12 ) .


Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were : heartburn , abdominal pain and the presence of black stools ( all p0 .03 ) .


A tool for the detection of commonly-occurring side effects should not require large study numbers to be effective .


With just 10 subjects per group ( iron or placebo ) , this simple questionnaire measures gastrointestinal side-effects associated with oral iron ( ferrous sulphate ) supplementation , and would be appropriate for use in intervention studies or clinical trials .


ClinicalTrials.gov Identifier : NCT02146053 ( 21/05/2014 ) .


E-health initiatives hold promise to improve shared-care models of health care .


In 2008-2011 we developed and trialled web-based software to facilitate a randomised trial of a shared-care approach for childhood obesity involving General Practitioners ( GPs ) working with tertiary specialists .


We describe the software 's development , implementation and evaluation , and make recommendations for future e-health initiatives .


The web-based software was designed with the goals of allowing both GPs and specialists to communicate and review patient progress ; integrating with existing GP software ; and supporting GPs to deliver the structured intervention .


Specifically , we aimed to highlight the challenges inherent in this process , and report on the extent to which the software ultimately met its implementation and user aims .


The study was conducted at the Royal Children 's Hospital and 22 general practices across Melbourne , Australia .


Participants comprised 30 GPs delivering the shared-care intervention .


Outcomes included the following .


( 1 ) GPs ' pre-specified software requirements : transcribed from two focus groups and analysed for themes using content analysis .


( 2 ) Software implementation and performance based on the experience of the research team and GPs .


( 3 ) GP users ' evaluation collected via questionnaire .


( 4 ) Software usage collected via GP questionnaire and qualified through visual inspection of the software meta-data .


Software implementation posed difficult and at times disabling technological barriers ( e.g. out-dated hardware , poor internet connections ) .


The software 's speed and inability to seamlessly link with day-to-day software was a source of considerable frustration .


Overall , GPs rated software usability as poor , although most ( 68 % ) felt that the structure and functionality of the software was useful .


Recommendations for future e-health initiatives include thorough scoping of IT systems and server speed , testing across diverse environments , automated pre-requisite checks and upgrades of processors/memory where necessary , and user-created usernames and passwords .


GPs are willing to embrace novel technologies to support their practice .


However , implementation remains challenging mainly for technical reasons , and this precludes further evaluation of potential user-specific barriers .


These findings could inform future e-health ventures into shared-care , and highlight the need for an appropriate infrastructure .


Australian New Zealand Clinical Trials Registry : ACTRN126080000553 .


The aim of this study was to assess the efficacy of using a combination treatment approach consisting of lipid emulsion eye drops , eyelid cleansing wipes , and omega-3 vitamin supplements compared with warm compresses in improving meibomian gland functionality in patients with lipid-deficient/evaporative dry eye disease ( LDDE ) .


This single-center , open-label , investigator-masked , randomized study enrolled patients aged 18 years , clinically diagnosed with LDDE defined as having 6 functional meibomian glands [ meibomian gland yielding liquid secretion ( MGYLS ) ] and positive for dry eye symptoms at screening .


Patients were randomized to receive either the combination treatment ( lipid emulsion eye drops , omega-3 supplements , and lid hygiene with eyelid wipes ) or to apply warm , wet compresses once daily , 8 minutes per day , for 3 months .


Meibomian gland functionality ( number of MGYLS ; primary outcome ) and patient-reported subjective assessments ( SPEED and OSDI questionnaires ; secondary outcomes ) were evaluated .


Adverse events ( AEs ) and visual acuity were assessed as safety endpoints .


Mean patient age was 41.7 years ( n = 26 ; n = 13 per group ) .


Mean SD number of MGYLS was not statistically significantly different between groups at baseline ( combination treatment , 3.5 1.5 ; warm compresses , 4.2 1.4 , P > 0.5 ) , and was significantly greater with combination treatment versus warm compresses after 3 months of treatment ( 9.3 2.7 vs. 4.7 2.3 ; P = 0.006 ) .


Dry eye symptoms were significantly improved in both groups at all follow-up visits .


Two AEs unrelated to treatment were reported ; the BCVA was unchanged from baseline in both groups .


The combination treatment regimen resulted in significant improvement in meibomian gland functionality and dry eye symptoms .


No safety issues were observed .


Radiotherapy-induced trismus ( RTIT ) is a debilitating condition without any proven effective treatment .


This study investigates the effectiveness of prophylactic training to prevent RTIT during and up to 12 months after completed RT in patients with head and neck cancer ( HNC ) , also investigating the incidence of RTIT .


Sixty-six consecutive patients from two RT clinics in Sweden were randomised into one of two groups : training with TheraBite ( ) Jaw Motion Rehabilitation System ( ) or a control group .


Maximum interincisal openings ( MIO ) were recorded at baseline and once a week during treatment , three , six and 12 months after completed RT. .


Training frequency was recorded by patients in a log book .


There were no significant differences in MIO between the intervention and control groups at any of the measurement points .


Patients in both groups maintained their normal variation in MIO at 12 months after completed RT. .


A small group of patients in the control group had a 17 % mean decrease in MIO by week 6 compared to baseline and improved their MIO by using the training programme .


There was a significant mean difference in MIO from baseline to week 6 ( 3 mm , p = 0.018 ) , and month 6 ( 2.7 mm , p = 0.040 ) , for patients receiving 3D conformal radiotherapy .


There was a significant difference in MIO between patients treated with RT and concurrent chemotherapy compared to patients with RT only at 12 months ( p = 0.033 ) .


Patients with HNC undergoing high dose RT do not need to be burdened with an intense prophylactic training programme during RT and up to 12 months after completed RT. .


MIO measurements during RT and up to 12 months after completed RT are recommended to identify a small risk group who are an exception and may need a training programme .


This study investigated the acute hemodynamic responses to multiple sets of passive stretching exercises performed with and without the Valsalva maneuver .


Fifteen healthy men aged 21 to 29 years with poor flexibility performed stretching protocols comprising 10 sets of maximal passive unilateral hip flexion , sustained for 30 seconds with equal intervals between sets .


Protocols without and with the Valsalva maneuver were applied in a random counterbalanced order , separated by 48-hour intervals .


Hemodynamic responses were measured by photoplethysmography pre-exercise , during the stretching sets , and post-exercise .


The effects of stretching sets on systolic and diastolic blood pressure were cumulative until the fourth set in protocols performed with and without the Valsalva maneuver .


The heart rate and rate pressure product increased in both protocols , but no additive effect was observed due to the number of sets .


Hemodynamic responses were always higher when stretching was performed with the Valsalva maneuver , causing an additional elevation in the rate pressure product .


Multiple sets of unilateral hip flexion stretching significantly increased blood pressure , heart rate , and rate pressure product values .


A cumulative effect of the number of sets occurred only for systolic and diastolic blood pressure , at least in the initial sets of the stretching protocols .


The performance of the Valsalva maneuver intensified all hemodynamic responses , which resulted in significant increases in cardiac work during stretching exercises .


To assess whether granulocyte colony-stimulating factor ( G-CSF ) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction ( STEMI ) and left ventricular ( LV ) dysfunction after successful reperfusion .


The STEM-AMI Trial was a prospective , placebo-controlled , multicentre study .


Sixty consecutive patients with a first anterior STEMI , who underwent primary percutaneous coronary intervention 2-12 h after symptom onset , with LV ejection fraction ( LVEF ) 45 % measured by echocardiography within 12 h after successful revascularisation ( TIMI flow score 2 ) , were randomised 1:1 to G-CSF ( 5 g/Kg body weight b.i.d. ) or placebo .


Clinical events and Major Adverse Cardiac and Cerebrovascular Event ( MACCE ) were monitored , and LVEF , LV end-diastolic ( LVEDV ) and end-systolic ( LVESV ) volumes , and infarct size were evaluated by MRI at the final 3-year follow-up .


Fifty-four patients completed the study , of whom 35 with MRI .


No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups .


The 3-year infarct size was not different between groups , whereas LVEDV was significantly lower in G-CSF ( n = 20 ) than in placebo ( n = 15 ) patients ( 170.18.1 vs 197.28.9 mL , respectively ; p = 0.033 at analysis of covariance ) .


A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV ( = -0.71 , 95 % CI -0.90 to -0.30 , and = -0.62 , -0.86 to -0.14 , respectively ) , or their change over time ( r = -0.59 , -0.85 to -0.11 , and r = -0.55 , -0.83 to -0.06 , respectively ) .


G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term .


No differences have been detected in clinical outcome .


To identify risk factors for development of hypophosphataemia in patients treated with two different intensities of continuous renal replacement therapy ( CRRT ) and to assess the independent association of hypophosphataemia with major clinical outcomes .


We performed secondary analysis of data collected from 1441 patients during a large , multicentre randomised controlled trial of CRRT intensity .


We allocated patients to two different intensities of CRRT ( 25mL/kg/hour vs 40 mL/kg/hour of effluent generation ) and obtained daily measurement of serum phosphate levels .


We obtained 14 115 phosphate measurements and identified 462 patients ( 32.1 % ) with hypophosphataemia , with peak incidence on Day 2 and Day 3 .


With lower intensity CRRT , there were 58 episodes of hypophosphataemia/1000 patient days , compared with 112 episodes/1000 patient days with higher intensity CRRT ( P < 0.001 ) .


On multivariable logistic regression analysis , higher intensity CRRT , female sex , higher Acute Physiology and Chronic Health Evaluation score and hypokalaemia were independently associated with an increased odds ratio ( OR ) for hypophosphataemia .


On multivariable models , hypophosphataemia was associated with better clinical outcomes , but when analysis was confined to patients alive at 96 hours , hypophosphataemia was not independently associated with clinical outcomes .


Hypophosphataemia is common during CRRT and its incidence increases with greater CRRT intensity .


Hypophosphataemia is not a robust independent predictor of mortality .


Its greater incidence in the higher intensity CRRT arm of the Randomised Evaluation of Normal vs Augmented Level trial does not explain the lack of improved outcomes with such treatment .


Irritable bowel syndrome ( IBS ) is among the most common gastrointestinal disorders worldwide .


In selected patients with severe diarrhoea-predominant or mixed IBS subtypes sacral nerve stimulation ( SNS ) alleviates IBS-specific symptoms and improves quality of life .


The mode of action , however , remains unknown .


The present study aimed to evaluate the effect of SNS on small intestinal motility in IBS patients .


Twenty patients treated with SNS for severe diarrhoea-predominant or mixed IBS were included in a randomised , controlled , crossover study .


The neurostimulator was turned ON or OFF for the first one month and then to the opposite setting for the next month .


Gastrointestinal transit patterns were investigated with the Motility Tracking System-1 ( MTS-1 ) at the end of each the ON and OFF period .


Primary endpoint was change in the velocity of the magnetic pill within the small intestine .


Statistical testing was performed with Wilcoxon 's rank sum test and Fisher 's exact test .


The median velocity of the magnetic pill through the small intestine in the fasting state was not significantly different between periods with and without SNS ( Group ON-OFF : median change 0 m/h ( range -1.07 , 0.63 ) , Group OFF-ON : median change 0.27 m/h ( range -0.59 , 1.12 ) ) ( p = 0.25 ) .


Neither , was the median velocity of the magnetic pill through the small intestine in the postprandial state significantly different between periods with and without SNS ( Group ON-OFF : median change -0.13 m/h ( range -0.46 , 0.23 ) , Group OFF-ON : median change 0.015 m/h ( range -0.48 , 0.59 ) ) ( p = 0.14 ) .


Even though SNS may reduce symptoms of diarrhoea-predominant and mixed IBS , it has no detectable effect on small intestinal transit patterns .


Clinical.trials.gov , ( NCT00919672 ) .


Fetal survival is severely compromised when the amniotic membrane ruptures between 16 and 24 weeks of pregnancy .


Reduced amniotic fluid levels are associated with poor lung development , whereas adequate levels lead to better perinatal outcomes .


Restoring amniotic fluid by means of ultrasound-guided amnioinfusion ( AI ) may be of benefit in improving perinatal and long-term outcomes in children of pregnancies with this condition .


The AI in preterm premature rupture of membranes ( AMIPROM ) pilot study was conducted to assess the feasibility of recruitment , the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes ( between 16 and 24 weeks of pregnancy ) .


It was also performed to assess outcomes and collect data to inform a larger , more definitive , clinical trial .


A prospective , non-blinded randomised controlled trial .


A computer-generated random sequence using a 1 : 1 ratio was used .


Randomisation was stratified for pregnancies in which the amniotic membrane ruptured between 16 ( +0 ) and 19 ( +6 ) weeks ' gestation and 20 ( +0 ) and 24 ( +0 ) weeks ' gestation .


The randomisation sequence was generated in blocks of four .


Telephone randomisation and intention-to-treat analysis were used .


Four UK hospital-based fetal medicine units - Liverpool Women 's NHS Trust , St. Mary 's Hospital , Manchester , Birmingham Women 's NHS Foundation Trust and Wirral University Hospitals Trust .


Women with confirmed preterm prelabour rupture of membranes between 16 ( +0 ) and 24 ( +0 ) weeks ' gestation .


Women with multiple pregnancies , resultant fetal abnormalities or obstetric indication for immediate delivery were excluded .


Participants were randomly allocated to either serial weekly transabdominal AI or expectant management ( Exp ) until 37 weeks of pregnancy , if the deepest pool of amniotic fluid was < 2 cm .


Short-term maternal , pregnancy and neonatal outcomes and long-term outcomes for the child were studied .


Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6 , 12 and 18 months of age and infant lung function was assessed at approximately 12 months of age .


Neurodevelopment was assessed using Bayley 's Scale of Infant Development II at a corrected age of 2 years .


Fifty-eight women were randomised and two were excluded from the analysis owing to termination of pregnancy for lethal anomaly , leaving 56 participants ( 28 serial AI , 28 Exp ) recruited between 2002 and 2009 , with annual recruitment rates varying between 2 and 14 .


Recruitment to the study improved significantly from 2007 with National Institute for Health Research ( NIHR ) funding .


There was no significant difference in perinatal mortality [ 19/28 vs. 19/28 ; relative risk ( RR ) 1.0 ; 95 % confidence interval ( CI ) 0.70 to 1.43 ] , maternal morbidity or neonatal morbidity .


The overall chance of surviving without long-term respiratory or neurodevelopmental disability is 4/56 ( 7.1 % ) : 4/28 ( 14.3 % ) in the AI arm and 0/28 in the expectant arm ( 0 % ) ( RR 9.0 ; 95 % CI 0.51 to 159.70 ) .


This pilot study found no major differences in maternal , perinatal or pregnancy outcomes .


The study was not designed to show a difference between the arms and the number of survivors was too small to draw any conclusions about long-term outcomes .


It does signal , however , that a larger , definitive , study to evaluate AI for improvement in healthy survival is indicated .


The results suggest that , with appropriate funding , such a study is feasible .


A larger , definitive , study with full health economic analysis and patient perspective assessment is required to show whether AI can improve the healthy survivor rate .


Emergency endovascular repair ( EVAR ) for ruptured abdominal aortic aneurysm ( rAAA ) may have lower operative mortality rates than open surgical repair .


Concerns remain that the early survival benefit after EVAR for rAAA may be offset by late reinterventions .


The aim of this study was to compare reintervention rates and cost-effectiveness of EVAR and open repair for rAAA .


A retrospective analysis was undertaken of patients with rAAA undergoing EVAR or open repair over 6years .


A health economic model developed for the cost-effectiveness of elective EVAR was used in the emergency setting .


Sixty-two patients ( mean age 779years ) underwent EVAR and 85 ( mean age 759years ) had open repair of rAAA .


Median follow-up was 42 and 39months respectively .


There was no significant difference in 30-day mortality rates after EVAR and open repair ( 18 and 26 per cent respectively ; P = 0243 ) .


Reintervention rates were also similar ( 32 and 31 per cent ; P = 0701 ) .


The mean cost per patient was 26,725 for EVAR and 30,297 for open repair , and the cost per life-year gained was 7906 and 9933 respectively ( P = 0561 ) .


Open repair had greater initial costs : longer procedural times ( 217 versus 1785min ; P < 0001 ) and intensive care stay ( 50 versus 10days ; P = 0015 ) .


Conversely , EVAR had greater reintervention ( 156,939 versus 35,335 ; P = 0001 ) and surveillance ( P < 0001 ) costs .


There was no significant difference in reintervention rates after EVAR or open repair for rAAA .


EVAR was as cost-effective at mid-term follow-up .


The increased procedural costs of open repair are not outweighed by greater surveillance and reintervention costs after EVAR .


To compare the effects of real-time continuous glucose monitoring ( RT-CGM ) and an Internet blood glucose monitoring system ( IBGMS ) on glycated hemoglobin levels in patients with type 2 diabetes mellitus treated with insulin .


Fifty-seven patients with type 2 diabetes treated with insulin were assigned randomly to 1 of 2 groups .


Group 1 had the results of their self-monitoring of blood glucose level monitored biweekly using an IBGMS .


Group 2 used RT-CGM and were monitored biweekly .


Both groups used a secure website to upload data and to receive feedback from their endocrinologist .


A1C and laboratory test results were collected at 0 , 3 and 6 months .


The baseline parameters were not significantly different .


After a 6-month follow-up period , both IBGMS and RT-CGM showed significant within-group improvements in A1C level .


In the IBGMS group , the A1C level decreased from 8.79 % 1.25 % to 7.96 % 1.30 % ( p < 0.05 ) .


The RT-CGM group decreased from 8.80 % 1.37 % to 7.49 % 0.70 % ( p < 0.001 ) .


IBGMS and RT-CGM did not show significantly different A1C levels at baseline , 3 and 6 months ( p > 0.05 ) .


The use of both IBGMS and RT-CGM significantly improved A1C levels in patients with type 2 diabetes treated with insulin in a randomized trial over a 6-month period .


There were no significant differences in A1C values between groups after 6 months .


The aim of this study was to investigate the effects of a noninvasive positive pressure ventilation therapy on cardiac structure and function in patients with coronary heart disease combined with obstructive sleep apnea/hypopnea syndrome ( OSAHS ) .


Eighty patients with coronary heart disease OSAHS were divided randomly into treatment ( n = 40 ) and control ( n = 40 ) groups .


Both groups received standard medications .


The treatment group received additional noninvasive mechanical ventilation support for at least 3 h ( 3-6 h ) every night .


On the first day after selection and 3 months afterwards , participants were examined with echocardiograms , 24-h ambulatory blood pressure monitoring , and blood analyses .


Primary endpoints were left ventricular end-diastolic diameter , left ventricular end-systolic diameter , left ventricular ejection fraction , left atrial diameter as well as serum concentrations of N-terminal prohormone of brain natriuretic peptide , and high-sensitive C-reactive protein .


Secondary endpoints included cardiac death , nonfatal myocardial infarction , and hospitalization .


After the 3-month study period , patients in the treatment group showed significantly improved left ventricular end-diastolic diameter ( P = 0.02 ) , left ventricular end-systolic diameter ( P = 0.035 ) , left ventricular ejection fraction ( P = 0.05 ) , and left atrial diameter ( P = 0.02 ) values , and their serum N-terminal prohormone of brain natriuretic peptide ( P = 0.01 ) and high-sensitive C-reactive protein ( P = 0.04 ) concentrations were significantly improved compared with the control group .


During the 3 months , three cardiovascular complications occurred in the treatment group versus nine in the control group ( P < 0.05 ) .


For patients with coronary heart disease combined with OSAHS , noninvasive mechanical ventilation therapy can significantly improve heart functions and reduce the occurrence of cardiovascular complications .


After an intense bout of exercise , foam rolling is thought to alleviate muscle fatigue and soreness ( ie , delayed-onset muscle soreness [ DOMS ] ) and improve muscular performance .


Potentially , foam rolling may be an effective therapeutic modality to reduce DOMS while enhancing the recovery of muscular performance .


To examine the effects of foam rolling as a recovery tool after an intense exercise protocol through assessment of pressure-pain threshold , sprint time , change-of-direction speed , power , and dynamic strength-endurance .


Controlled laboratory study .


University laboratory .


A total of 8 healthy , physically active males ( age = 22.1 2.5 years , height = 177.0 7.5 cm , mass = 88.4 11.4 kg ) participated .


Participants performed 2 conditions , separated by 4 weeks , involving 10 sets of 10 repetitions of back squats at 60 % of their 1-repetition maximum , followed by either no foam rolling or 20 minutes of foam rolling immediately , 24 , and 48 hours postexercise .


Pressure-pain threshold , sprint speed ( 30-m sprint time ) , power ( broad-jump distance ) , change-of-direction speed ( T-test ) , and dynamic strength-endurance .


Foam rolling substantially improved quadriceps muscle tenderness by a moderate to large amount in the days after fatigue ( Cohen d range , 0.59 to 0.84 ) .


Substantial effects ranged from small to large in sprint time ( Cohen d range , 0.68 to 0.77 ) , power ( Cohen d range , 0.48 to 0.87 ) , and dynamic strength-endurance ( Cohen d = 0.54 ) .


Foam rolling effectively reduced DOMS and associated decrements in most dynamic performance measures .


Evaluate a computerized intervention supporting antiretroviral therapy ( ART ) adherence and HIV transmission prevention .


Longitudinal randomized controlled trial .


An academic HIV clinic and a community-based organization in Seattle .


In a total of 240 HIV-positive adults on ART , 209 completed 9-month follow-up ( 87 % retention ) .


Randomization to computerized counseling or assessment only , 4 sessions over 9 months .


HIV-1 viral suppression , and self-reported ART adherence and transmission risks , compared using generalized estimating equations .


Overall , intervention participants had reduced viral load : mean 0.17 log10 decline , versus 0.13 increase in controls , P = 0.053 , and significant difference in ART adherence baseline to 9 months ( P = 0.046 ) .


Their sexual transmission risk behaviors decreased ( odds ratio = 0.55 , P = 0.020 ) , a reduction not seen among controls ( odds ratio = 1.1 , P = 0.664 ) , and a significant difference in change ( P = 0.040 ) .


Intervention effect was driven by those most in need ; among those with detectable virus at baseline ( > 30 copies/mL , n = 89 ) , intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls , P = 0.034 .


ART adherence at the final follow-up was 13 points higher among intervention participants versus controls , P = 0.038 .


Computerized counseling is promising for integrated ART adherence and safer sex , especially for individuals with problems in these areas .


This is the first intervention to report improved ART adherence , viral suppression , and reduced secondary sexual transmission risk behavior .


Ureteric stones greater than 6mm require intervention .


Extracorporeal shockwave lithotripsy ( ESWL ) and ureteroscopy ( URS ) with intra-corporeal lithotripsy ( ICL ) are two least invasive therapies .


Both show acceptable stone clearance .


What should be the first line of treatment in distal ureteric stones ?


We conducted this study to compare the efficacy-of ESWL and pneumatic ICL in order to develop clear cut treatment guidelines .


This randomized control trial was conducted at Institute of Kidney Diseases , Peshawar from June 2011 to June 2012 .


Two hundred and twenty-four patients with distal ureteric stones 6-12 mm in size were included .


Patients were randomized into two groups .


Group-A patients were treated with URS plus ICL and Group-B with ESWL .


Patients were evaluated for stone clearance after 2 weeks , with X-ray KUB and ultrasound .


All the data were recorded in a pro forma and analysed in SPSS 10 .


Fisher 's exact test was applied to compare the efficacy and a p-value of 0.05 was considered significant .


Out of 112 patients in Group-A , 75 ( 67 % ) were males and 37 ( 33 % ) were females while in Group-B 79 ( 70.5 % ) were males and 33 ( 29.5 % ) were females .


The mean age in Group-A was , 48.73 + / - 16.23 years whereas it was 46 + / - 14.58 years in Group-B .


Overall , mean age was 47.36 + / -15.4 years .


Mean stone size was 9.18 + / - 1.6 mm .


At follow up ( 2 weeks post-operative ) URS with ICL was successful in 101 ( 90.2 % ) patients while ESWL was successful in 75 ( 67 % ) patients ( p-value = 0.0001 ) .


Extracorporeal shockwave lithotripsy shows acceptable stone clearance but ureteroscopy with intra-corporeal lithotripsy shows superior results in distal ureteric stones .


Preclinical and early clinical data support the use of Vascular Epithelial Growth Factor ( VEGF ) - targeted therapy with trastuzumab in Human Epidermal Receptor 2 ( HER2 ) positive breast cancer .


Adding bevacizumab to a taxane ( docetaxel or paclitaxel ) improves progression free survival ( PFS ) of metastatic breast cancer ( MBC ) patients .


We evaluated the efficacy and feasibility of combining bevacizumab with trastuzumab and docetaxel in patients with HER2 - positive MBC who received 0-1 prior chemotherapy regimens for metastatic disease .


The primary end point was PFS .


Eligible patients received bevacizumab ( 15 mg/kg ) , trastuzumab ( 8 mg/kg loading dose followed by 6 mg/kg ) , and docetaxel ( 100 mg/m2 initially , later amended to 75 mg/m2 ) every three weeks for six cycles and then were allowed to receive bevacizumab and trastuzumab alone .


Results Thirteen ( 50 % ) of 26 patients enrolled completed all 6 cycles of bevacizumab , trastuzumab and docetaxel and went on to receive bevacizumab and trastuzumab alone ( median : 11 cycles ) .


The most common grade 3 or 4 toxicities include : neutropenia ( 8 % ) , septic death ( 4 % ) , infection not associated with neutropenia ( 15 % ) , fatigue ( 27 % ) , mylagia and/or arthraligia ( 20 % ) , and hand-foot syndrome ( 8 % ) .


One patient ( 4 % ) and six patients ( 23 % ) developed grade 3 and grade 2 hypertension , respectively .


Two ( 8 % ) patients had transient grade 2 drop in Left Ventricular Ejection Fraction ( LVEF ) with full recovery later .


The median progression free survival ( PFS ) was 14.3 months ( 95 % CI : 9.3-35 months ) , the objective response rate ( ORR ) , defined as the best response of complete response ( CR ) or partial response ( PR ) was ( 12/26 ) 46 % .


The clinical benefit rate ( CBR ) , defined as the best response of CR or PR or stable disease ( SD ) for at least 24 weeks , was ( 18/26 ) 69 % ( 95 % CI : 48-86 % ) .


The combination of bevacizumab , trastuzumab and docetaxel is well tolerated and is clinically active in patients with HER2-positive MBC , with response rate and PFS comparable to previous reports utilizing higher dose of docetaxel ( 100 mg/m2 ) .


Recent randomized trials did not demonstrate additional overall survival ( OS ) benefit of adding bevacizumab to trastuzumab and docetaxel despite an improvement in PFS .


Identification of predictive biomarkers and careful patient selection should be incorporated in further investigation of anti-VEGF in breast cancer .


The purpose of this study was to determine among maintenance hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension whether in comparison with a - blocker-based antihypertensive therapy , an angiotensin converting enzyme-inhibitor-based antihypertensive therapy causes a greater regression of left ventricular hypertrophy .


Subjects were randomly assigned to either open-label lisinopril ( n = 100 ) or atenolol ( n = 100 ) each administered three times per week after dialysis .


Monthly monitored home blood pressure ( BP ) was controlled to < 140/90 mmHg with medications , dry weight adjustment and sodium restriction .


The primary outcome was the change in left ventricular mass index ( LVMI ) from baseline to 12 months .


At baseline , 44-h ambulatory BP was similar in the atenolol ( 151.5 / 87.1 mmHg ) and lisinopril groups , and improved similarly over time in both groups .


However , monthly measured home BP was consistently higher in the lisinopril group despite the need for both a greater number of antihypertensive agents and a greater reduction in dry weight .


An independent data safety monitoring board recommended termination because of cardiovascular safety .


Serious cardiovascular events in the atenolol group occurred in 16 subjects , who had 20 events , and in the lisinopril group in 28 subjects , who had 43 events { incidence rate ratio ( IRR ) 2.36 [ 95 % confidence interval ( 95 % CI ) 1.36-4 .23 , P = 0.001 ] } .


Combined serious adverse events of myocardial infarction , stroke and hospitalization for heart failure or cardiovascular death in the atenolol group occurred in 10 subjects , who had 11 events and in the lisinopril group in 17 subjects , who had 23 events ( IRR 2.29 , P = 0.021 ) .


Hospitalizations for heart failure were worse in the lisinopril group ( IRR 3.13 , P = 0.021 ) .


All-cause hospitalizations were higher in the lisinopril group [ IRR 1.61 ( 95 % CI 1.18-2 .19 , P = 0.002 ) ] .


LVMI improved with time ; no difference between drugs was noted .


Among maintenance dialysis patients with hypertension and left ventricular hypertrophy , atenolol-based antihypertensive therapy may be superior to lisinopril-based therapy in preventing cardiovascular morbidity and all-cause hospitalizations .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases ; ClinicalTrials.gov number : NCT00582114 ) .


We tested a modified Network for the Improvement of Addiction Treatment ( NIATx ) process improvement model to implement improved HIV services ( prevention , testing , and linkage to treatment ) for offenders under correctional supervision .


As part of the Criminal Justice Drug Abuse Treatment Studies , Phase 2 , the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites , where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training .


The outcome measure was the odds of successful delivery of an HIV service .


The results were significant at the .05 level , and the point estimate for the odds ratio was 2.14 .


Although overall the results were heterogeneous , the experiments that focused on implementing HIV prevention interventions had a 95 % confidence interval that exceeded the no-difference point .


Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments .


Based on experimental results , various authors have advocated a size 4 ProSeal laryngeal mask airway ( PLMA ) in preference to a size 3 PLMA for women given a neuromuscular blocking agent because the larger size provided a better airway seal .


However , spontaneously breathing patients may be ventilated adequately with a lower seal pressure than that needed for mechanical ventilation .


Therefore , a smaller size might be preferable as its reduced bulk possibly induces less mucosal damage in non-paralyzed patients .


A total of 152 females undergoing general anesthesia for short outpatient gynecological surgeries were randomly allocated in equal numbers to insertion of a size 3 or 4 PLMA .


The insertion time , success rate , seal pressure , hemodynamic variables , and complications , such as blood staining and sore throat , were evaluated .


The incidence of blood staining was lower with the size 3 PLMA compared to the size 4 PLMA ( 18 vs. 36 % ; P = 0.028 ) .


Compared with the size 3 LMA , the size 4 PLMA resulted in higher fluctuations in both blood pressure ( P = 0.003 ) and heart rate ( P = 0.01 ) .


The insertion time was shorter with the size 3 PLMA ( 9 vs. 16s ; P < 0.001 ) .


The airway seal pressure with the size 3 PLMA , although lower than that of the size 4 PLMA ( 23 vs. 28 cmH2O ; P = 0.001 ) , was sufficient for spontaneous ventilation .


Due to the reduced incidence of mucosal injury and greater hemodynamic stability , the size 3 PLMA may be preferable to the size 4 PLMA for non-paralyzed females .


Asymptomatic hyperuricemia increases renal and cardiovascular ( CV ) risk .


We previously conducted a 2-year , single-blind , randomized , controlled trial of allopurinol treatment that showed improved estimated glomerular filtration rate and reduced CV risk .


Post hoc analysis of a long-term follow-up after completion of the 2-year trial .


113 participants ( 57 in the allopurinol group and 56 in the control group ) initially followed up for 2 years and 107 participants followed up to 5 additional years .


Continuation of allopurinol treatment , 100mg/d , or standard treatment .


Renal event ( defined as starting dialysis therapy and/or doubling serum creatinine and/or 50 % decrease in estimated estimated glomerular filtration rate ) and CV events ( defined as myocardial infarction , coronary revascularization or angina pectoris , congestive heart failure , cerebrovascular disease , and peripheral vascular disease ) .


During initial follow-up , there were 2 renal and 7 CV events in the allopurinol group compared with 6 renal and 15 CV events in the control group .


In the long-term follow-up period , 12 of 56 participants taking allopurinol stopped treatment and 10 of 51 control participants received allopurinol .


During long-term follow-up , an additional 7 and 9 participants in the allopurinol group experienced a renal or CV event , respectively , and an additional 18 and 8 participants in the control group experienced a renal or CV event , respectively .


Thus , during the initial and long-term follow-up ( median , 84 months ) , 9 patients in the allopurinol group had a renal event compared with 24 patients in the control group ( HR , 0.32 ; 95 % CI , 0.15-0 .69 ; P = 0.004 ; adjusted for age , sex , baseline kidney function , uric acid level , and renin-angiotensin-aldosterone system blockers ) .


Overall , 16 patients treated with allopurinol experienced CV events compared with 23 in the control group ( HR , 0.43 ; 95 % CI , 0.21-0 .88 ; P = 0.02 ; adjusted for age , sex , and baseline kidney function ) .


Small sample size , single center , not double blind , post hoc follow-up and analysis .


Long-term treatment with allopurinol may slow the rate of progression of kidney disease and reduce CV risk .


This investigation compared cotinine ( primary metabolite of nicotine ) at study intake to self-report metrics ( e.g. , Fagerstrom Test of Nicotine Dependence [ FTND ] ) and assessed their relative ability to predict smoking outcomes .


We used data from an analog model of contingency management for cigarette smoking .


Non-treatment seeking participants ( N = 103 ) could earn money in exchange for provision of a negative carbon monoxide ( CO ) sample indicating smoking abstinence , but were otherwise not motivated to quit .


We used intake cotinine , FTND , percent of friends who smoke , and years smoked to predict longitudinal CO and attendance , time-to-first positive CO submission , and additional cross-sectional outcomes .


Intake cotinine was consistently predictive ( p < .05 ) of all outcomes ( e.g. , longitudinal CO and attendance , 100 % abstinence , time-to-first positive CO sample ) , while years smoked was the only self-report metric that demonstrated any predictive ability .


Cotinine could be more informative for tailoring behavioral treatments compared to self-report measures .


Tocopherols were discovered for their role in animal reproduction , but little is known about the contribution of deficiencies of vitamin E to human pregnancy loss .


We sought to determine whether higher first-trimester concentrations of - tocopherol and - tocopherol were associated with reduced odds of miscarriage ( pregnancy losses < 24 wk of gestation ) in women in rural Bangladesh .


A case-cohort study in 1605 pregnant Bangladeshi women [ median ( IQR ) gestational age : 10 wk ( 8-13 wk ) ] who participated in a placebo-controlled vitamin A - or - carotene-supplementation trial was done to assess ORs of miscarriage in women with low - tocopherol ( < 12.0 mol/L ) and - tocopherol ( < 0.81 mol/L ; upper tertile cutoff of the - tocopherol distribution in women who did not miscarry ) .


In all women , plasma - and - tocopherol concentrations were low [ median ( IQR ) : 10.04 mol/L ( 8.07-12 .35 mol/L ) and 0.66 mol/L ( 0.50-0 .95 mol/L ) , respectively ] .


In a logistic regression analysis that was adjusted for cholesterol and the other tocopherol , low - tocopherol was associated with an OR of 1.83 ( 95 % CI : 1.04 , 3.20 ) , whereas a low - tocopherol concentration was associated with an OR of 0.62 ( 95 % CI : 0.41 , 0.93 ) for miscarriage .


Subgroup analyses revealed that opposing ORs were evident only in women with BMI ( in kg/m ( 2 ) ) 18.5 and serum ferritin concentration 150 g/L , although low BMI and elevated ferritin conferred stronger risk of miscarriage .


In pregnant women in rural Bangladesh , low plasma - tocopherol was associated with increased risk of miscarriage , and low - tocopherol was associated with decreased risk of miscarriage .


Maternal vitamin E status in the first trimester may influence risk of early pregnancy loss .


The JiVitA-1 study , from which data for this report were derived , was registered at clinicaltrials.gov as NCT00198822 .


The routine use of neuromuscular blocking agents reduces the occurrence of unacceptable surgical conditions .


In some surgeries , such as retroperitoneal laparoscopies , deep neuromuscular block ( NMB ) may further improve surgical conditions compared with moderate NMB .


In this study , the effect of deep NMB on surgical conditions was assessed .


Twenty-four patients undergoing elective laparoscopic surgery for prostatectomy or nephrectomy were randomized to receive moderate NMB ( train-of-four 1-2 ) using the combination of atracurium/mivacurium , or deep NMB ( post-tetanic count 1-2 ) using high-dose rocuronium .


After surgery , NMB was antagonized with neostigmine ( moderate NMB ) , or sugammadex ( deep NMB ) .


During all surgeries , one surgeon scored the quality of surgical conditions using a five-point surgical rating scale ( SRS ) ranging from 1 ( extremely poor conditions ) to 5 ( optimal conditions ) .


Video images were obtained and 12 anaesthetists rated a random selection of images .


Mean ( standard deviation ) SRS was 4.0 ( 0.4 ) during moderate and 4.7 ( 0.4 ) during deep NMB ( P < 0.001 ) .


Moderate block resulted in 18 % of scores at the low end of the scale ( Scores 1-3 ) ; deep block resulted in 99 % of scores at the high end of the scale ( Scores 4 and 5 ) .


Cardiorespiratory conditions were similar during and after surgery in both groups .


Between anaesthetists and surgeon , there was poor agreement between scores of individual images ( average statistic 0.05 ) .


Application of the five-point SRS showed that deep NMB results in an improved quality of surgical conditions compared with moderate block in retroperitoneal laparoscopies , without compromise to the patients ' peri - and postoperative cardiorespiratory conditions .


Trial registration The study was registered at clinicaltrials.gov under number NCT01361149 .


To determine if injection of local anesthetic into trocar insertion sites after laparoscopy improves postoperative pain .


A prospective , 2-arm , randomized , double-blind , stratified , and controlled trial ( Canadian Task Force classification I ) .


A university-based teaching hospital .


This study was performed on women who had a laparoscopic gynecologic procedure for benign indications from March 2013 to June 2013 .


One hundred thirty-five subjects were stratified by chronic pelvic pain or no chronic pelvic pain .


Chronic pelvic pain was defined as pelvic pain occurring for 6 months or more in duration .


Randomization was performed for this trial , with 68 receiving a bupivacaine block and 67 receiving no bupivacaine block .


Of the 71 patients with chronic pelvic pain , 35 patients were in group 1 ( i.e. , bupivacaine block ) and 36 patients were in group 2 ( i.e. , no bupivacaine block ) .


After the laparoscopic surgery was completed , the trocar incision sites were closed .


For subjects randomized to receive a local anesthesia block , bupivacaine ( 0.25 % ) was injected .


Incisions 8 mm or greater were injected with 10 mL 0.25 % bupivacaine .


Incisions 5 mm or less were infiltrated with 5 mL .


Injecting the local anesthetic through all preperitoneal layers provided a full-thickness local injection .


Group 2 did not receive a local injection .


At the preoperative suite , the nurses gauged the patient 's pain using the Numeric Rating Scale .


This score was used as the baseline pain level with which the postoperative pain scores were compared .


The primary objective was to measure changes in pain scores , from preoperative to postoperative time frames of 2 to 4 hours , 6 to 8 hours , 18 to 24 hours , and 3 to 7 days postoperatively .


These score changes were measured as the main objective .


Secondary objectives include estimated blood loss , operating time , length of hospital stay , and histopathologic diagnosis .


The hospital personnel caring for the patient during the preoperative and postoperative course were given standard pain evaluation protocols .


All study pain evaluators and patients were blinded to treatment assignments throughout the pain assessment process .


There were no statistically significant differences in patient characteristics between the 2 treatment groups .


No significant difference was found in secondary outcomes including estimated blood loss , length of hospital stay , and histopathologic diagnosis .


In general , Numeric Rating Scale pain scores were lower ( i.e. , less pain ) in the `` bupivacaine block '' group compared with the `` no bupivacaine '' block group at the following postsurgery time assessments : 2 to 4 hours , 6 to 8 hours , 18 to 24 hours , and 3 to 7 days after surgery .


However , the effect was not large enough ( < 1 point ) to show a statistical difference between the treatment groups at any of these postsurgery assessments .


The postoperative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery .


The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study .


SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone .


At 6 months , 37 control subjects crossed over to renal denervation .


Office blood pressure measurements , antihypertensive medication use , and safety events were followed every 6 months through 3 years .


Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months .


Baseline blood pressure was 184 19/99 16 mmHg in all treated subjects .


At 30-month post-procedure , systolic blood pressure decreased 34 mmHg ( 95 % CI : -40 , -27 , P < 0.01 ) and diastolic blood pressure decreased 13 mmHg ( 95 % CI : -16 , -10 , P < 0.01 ) .


The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg ( 95 % CI : -40 , -25 , P < 0.01 ) and -14 mmHg ( 95 % CI : -17 , -10 , P < 0.01 ) , respectively .


Procedural complications included one haematoma , and one renal artery dissection before energy delivery that was treated successfully .


Later complications included two cases of acute renal failure , which fully resolved , 15 hypertensive events requiring hospitalization , and three deaths .


Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe , treatment-resistant hypertension without serious safety concerns .


NCT00888433 .


To compare onset time and quality of sedation achieved by IM injection of hydromorphone and dexmedetomidine into either the semimembranosus , cervical , gluteal , or lumbar muscle groups in dogs .


Prospective , randomized , crossover study .


7 dogs .


Each dog was assigned to receive each treatment in random order , and at least 1 week elapsed between treatments .


Dogs were sedated with dexmedetomidine and hydromorphone combined and injected IM into the assigned muscle group .


An observer unaware of group assignments assessed physiologic variables every 5 minutes for 30 minutes , and a videographic recording was obtained .


Recordings were evaluated by 16 individuals who were unaware of group assignments ; these reviewers assessed time to onset of sedation and assigned a sedation score to each dog every 5 minutes .


Resting pulse and respiratory rates did not differ among injection site groups .


The semimembranosus site had a significantly higher sedation score than all other sites , and the cervical site had a significantly higher sedation score than the lumbar and gluteal sites .


The semimembranosus and cervical sites had significantly shorter time to onset of sedation than did the gluteal and lumbar sites .


When the combination of dexmedetomidine and hydromorphone was used to induce sedation in dogs , rapid and profound sedation was achieved with IM injection into the semimembranosus muscle .


Despite the laparoscopic approach becoming the standard in colorectal surgery , postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures .


Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery .


Epidural analgesia provides excellent analgesia , but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced .


Moreover , epidural analgesia can be associated with numerous complications .


Therefore , epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery .


Likewise , patient-controlled intravenous analgesia is subject to significant side effects .


Given these important limitations of the traditional strategies for postoperative analgesia , effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed .