Maximal detrusor pressure and maximal urethral closure pressure significantly decreased in both groups , whereas maximal cystometric capacity increased significantly in group 1 only ( 290.8-332 .0 cm H2O ; P < .001 ) .


Anticholinergics may facilitate early recovery from incontinence and prevent worsening of quality of life , which might be attributed to increased cystometric capacity after their use .


Endoscopic biliary sphincterotomy ( EBS ) results in permanent loss of sphincter function and its long-term complications are unknown .


Endoscopic papillary balloon dilation ( EPBD ) is an alternative procedure that preserves sphincter function , although it is associated with a higher risk of pancreatitis than is EBS .


The aim of this study was to evaluate the safety and outcomes of EPBD with limited indications for removal of common bile duct ( CBD ) stones combined with gallstones in patients younger than 40 years .


Young ( age < 40 years ) patients who had CBD stones combined with gallstones on imaging studies were enrolled in this study .


A total of 132 patients were randomly divided into the EPBD group ( n = 62 ) or the EBS group ( n = 70 ) for extraction of CBD stones .


The ballooning size of EPBD ranged from 6 to 10 mm .


Complete bile duct clearance was achieved in 98.4 % ( 61/62 ) of the EPBD group and 100 % ( 70/70 ) of the EBS group .


Mechanical lithotripsy was required in 8.1 % ( 5/62 ) of the EPBD group and 8.6 % ( 6/70 ) of the EBS group .


The early complication rates were 8.1 % ( 5/62 ) ( five pancreatitis ) in the EPBD group and 11.4 % ( 8/70 ) ( five [ 7.1 % ] pancreatitis , two bleeding and one perforation ) in the EBS group .


The recurrence rates of CBD stones were 1.6 % ( 1/62 ) in the EPBD group and 5.7 % ( 4/70 ) in the EBS group .


EPBD with limited indications was safe and effective as EBS for removal of CBD stones combined with gallstones in young patients who had a longer life expectancy .


We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection ( STI ) behavioral intervention ( Providing Opportunities for Women 's Empowerment , Risk-Reduction , and Relationships , or POWER ) among incarcerated women .


We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011 .


Intervention participants attended 8 POWER sessions ; control participants received a single standard-of-care STI prevention session .


We followed up at 3 and 6 months after release .


We examined intervention efficacy with mixed-effects models .


POWER participants reported fewer male sexual partners than did control participants at 3 months , although this finding did not reach statistical significance ; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner .


POWER participants also reported significantly fewer condom barriers , and greater HIV knowledge , health-protective communication , and tangible social support .


The intervention had no significant effects on incident STIs .


POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities .


We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department ( ED ) with acute migraine .


This was a double-blind comparative efficacy trial .


Patients were randomized to 1,000 mg sodium valproate , 10 mg metoclopramide , or 30 mg ketorolac , each administered as an IV drip over 15 minutes .


The primary outcome was improvement in headache by 1 hour , measured on a verbal 0 to 10 scale , at baseline and 60 minutes later .


Important secondary outcomes included ( 1 ) need for rescue medication in the ED , and ( 2 ) sustained headache freedom .


Three hundred thirty patients were enrolled over 30 months beginning in October 2010 .


Baseline characteristics were comparable among the 3 arms .


On the primary outcome , patients receiving IV valproate improved by a mean of 2.8 ( 95 % confidence interval [ CI ] : 2.3 , 3.3 ) on the 0 to 10 scale ; those receiving IV metoclopramide improved by 4.7 ( 95 % CI : 4.2 , 5.2 ) ; and those receiving IV ketorolac improved by 3.9 ( 95 % CI : 3.3 , 4.5 ) .


On the secondary endpoints , 69 % ( 95 % CI : 60 % , 78 % ) of patients receiving valproate required rescue medication , compared with 33 % ( 95 % CI : 24 % , 42 % ) of metoclopramide patients and 52 % ( 95 % CI : 42 % , 63 % ) of those assigned to ketorolac .


Sustained headache freedom was achieved in 4 % ( 95 % CI : 0 % , 7 % ) of those randomized to valproate , 11 % ( 95 % CI : 5 % , 17 % ) of metoclopramide patients , and 16 % ( 95 % CI : 9 % , 23 % ) receiving ketorolac .


In the metoclopramide arm , 6 % ( 95 % CI : 3 % , 12 % ) of patients reported feeling `` very restless '' after investigational medication administration .


Valproate was less efficacious than either metoclopramide or ketorolac .


Metoclopramide demonstrated superiority to ketorolac on several endpoints .


This study provides Class I evidence that in ED patients with acute migraine , IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes .


To evaluate the effect of a combined hospital plus home exercise programme following curative surgery for non-small cell lung cancer ( NSCLC ) .


Randomised controlled trial .


Teaching hospital .


One hundred and thirty-one subjects with NSCLC admitted for curative surgery .


Participants were randomised to usual care or a hospital plus home exercise programme .


The primary outcome was the between-group difference in physical activity 4 weeks after surgery .


Secondary outcomes were the difference in quadriceps strength , exercise tolerance and quality of life [ Short Form-36 ( SF-36 ) and European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-LC13 ] from pre-operatively ( baseline ) to 4 weeks after surgery .


The participants ( n = 131 ) had a mean age of 68 [ standard deviation ( SD ) 11 ] years and mean forced expiratory volume in 1 second of 2.4 ( SD 1.1 ) l.


There were no significant differences in physical activity between the groups 4 weeks after surgery [ mean difference adjusted for baseline 12minutes/day , 95 % confidence interval ( CI ) -20.2 to 44.1 ] .


In addition , there were no significant differences in total SF-36 or EORTC QLQ-LC13 scores from baseline to 4 weeks after surgery .


Both groups had recovered their pre-operative walking distance 4 weeks after surgery , and there were no differences between the groups ( mean difference in Incremental Shuttle Walk Test from baseline to 4 weeks after surgery ( -26 m , 95 % CI -94.2 to 42.3 ) .


A hospital plus home exercise programme showed little benefit in unselected patients with NSCLC following surgery .


Regardless of group allocation , the patients had recovered their pre-operative exercise tolerance levels by 4 weeks after surgery .


The aim of this study was to investigate the influence of symptom duration on treatment response and on the correlation between improvements in patient reported outcomes ( PRO ) and objective inflammation in patients with axial spondylarthritis ( SpA ) treated with etanercept ( ETA ) or adalimumab ( ADA ) .


Data from 112 patients with axial SpA originally enrolled in two randomized controlled clinical trials were pooled and analyzed after one year of treatment with ETA ( n = 66 ) or ADA ( n = 46 ) .


Patients with < 4 years and 4 years of disease were compared for improvement in Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , C-reactive protein ( CRP ) and magnetic resonance imaging ( MRI ) score for sacroiliac joints ( SIJ ) .


Patients with < 4 years of disease showed a significantly better improvement than longer diseased patients in BASDAI ( 3.2 ( 95 % confidence interval ( CI ) : 2.7 to 3.7 ) vs. 1.7 ( 1.1 to 2.2 ) ) , BASFI , BASMI and ASDAS ( 1.6 ( 1.4 to 1.8 ) vs. 0.9 ( 0.7 to 1.1 ) ) .


The change in BASDAI showed a significant correlation with the change in SIJ score ( Spearman 's rank correlation coefficient ( rho ) = 0.37 , P = 0.01 ) and the change in CRP ( rho = 0.45 , P = 0.001 ) in patients with < 4 years of disease .


For long diseased patients this correlation was poor and did not achieve statistical significance ( rho = 0.13 , P = 0.46 ; rho = 0.22 , P = 0.13 respectively ) .


The low correlation between change of PROs and change of objective signs of inflammation seen in axial SpA patients with longer symptom duration treated with tumor necrosis factor-blocker seems to indicate that inflammation is not the only cause of the patients ' symptoms , while inflammation seems to be the major cause in short diseased patients .


Clinical Trials.gov NCT00844142 ( Trial 1 ) ; NCT00235105 ( Trial 2 ) .


Patients scheduled to invasive medical procedures experience high levels of anxiety , which may lead to increased perceptions of pain and vital sign instability throughout .


To examine the effect of a music intervention ( MI ) on stress hormones , physiologic parameters , pain , and anxiety state before and during port catheter placement procedures ( PCPPs ) .


We conducted a prospective , randomized , controlled study in 100 oncology patients , who were randomly assigned to an MI group ( n = 50 ) or a control group ( n = 50 ) .


The effects of music were assessed by determination of serum cortisol and adrenocorticotropic hormone ( ACTH ) levels , heart and respiratory rate ( HR , RR ) and systolic and diastolic blood pressure ( SBP , DBP ) , on arrival in the surgical intervention room , as well as immediately prior to and immediately after the PCPP , in both groups .


Furthermore , pain and anxiety levels were identified using visual analogue scale and state-trait anxiety inventory scales .


On arrival , there were no differences between the patients in terms of serum cortisol and ACTH levels , HR , RR , SBP , DBP and anxiety levels .


There were significant reductions in hormone levels ( p < 0.05 for all ) , HR ( p < 0.001 ) , RR ( p < 0.001 ) , SBP ( p < 0.05 ) and DBP ( p < 0.05 ) , immediately prior to and immediately after the PCPP in participants in the MI group compared to those in the control group .


Furthermore , music led to a significant reduction in pain ( p < 0.05 ) and anxiety scores ( p < 0.05 ) in the MI group compared to control group .


During invasive medical procedures , MI significantly decreases stress hormone levels , physiological parameters , acute procedural pain and anxiety .


To assess development of fatigue during chest compressions ( CCs ) in simulated neonatal cardiopulmonary resuscitation ( CPR ) .


Prospective randomized manikin crossover study .


Thirty neonatal healthcare professionals who successfully completed the Neonatal Resuscitation Program performed CPR using ( i ) 3:1 compression : ventilation ( C : V ) ratio , ( ii ) continuous CC with asynchronous ventilation ( CCaV ) at a rate of 90 CC per min and ( iii ) CCaV at 120 CC per min for a duration of 10 min on a neonatal manikin .


Changes in peak pressure ( a surrogate of fatigue ) and CC rate were continuously recorded and fatigue among groups was compared .


Participants were blinded to pressure tracings and asked to rate their level of comfort and fatigue for each CPR trial .


Compared with baseline , a significant decrease in peak pressure was observed after 72 , 96 and 156 s in group CCaV-120 , CCaV-90 and 3:1 C : V , respectively .


CC depth decreased by 50 % within the first 3 min during CCaV-120 , 30 % during CCaV-90 and 20 % during 3:1 C : V. Moreover , 3:1 C : V and CCaV were similarly preferred by healthcare professionals .


Similarly , 3:1 C : V and CCaV CPR were also fatiguing .


We recommend that rescuers should switch after every second cycle of heart rate assessment during neonatal CPR .


Biliary atresia is the most common cause of end-stage liver disease in children .


Controversy exists as to whether use of steroids after hepatoportoenterostomy improves clinical outcome .


To determine whether the addition of high-dose corticosteroids after hepatoportoenterostomy is superior to surgery alone in improving biliary drainage and survival with the native liver .


The multicenter , double-blind Steroids in Biliary Atresia Randomized Trial ( START ) was conducted in 140 infants ( mean age , 2.3 months ) between September 2005 and February 2011 in the United States ; follow-up ended in January 2013 .


Participants were randomized to receive intravenous methylprednisolone ( 4 mg/kg/d for 2 weeks ) and oral prednisolone ( 2 mg/kg/d for 2 weeks ) followed by a tapering protocol for 9 weeks ( n = 70 ) or placebo ( n = 70 ) initiated within 72 hours of hepatoportoenterostomy .


The primary end point ( powered to detect a 25 % absolute treatment difference ) was the percentage of participants with a serum total bilirubin level of less than 1.5 mg/dL with his/her native liver at 6 months posthepatoportoenterostomy .


Secondary outcomes included survival with native liver at 24 months of age and serious adverse events .


The proportion of participants with improved bile drainage was not statistically significantly improved by steroids at 6 months posthepatoportoenterostomy ( 58.6 % [ 41/70 ] of steroids group vs 48.6 % [ 34/70 ] of placebo group ; adjusted relative risk , 1.14 [ 95 % CI , 0.83 to 1.57 ] ; P = .43 ) .


The adjusted absolute risk difference was 8.7 % ( 95 % CI , -10.4 % to 27.7 % ) .


Transplant-free survival was 58.7 % in the steroids group vs 59.4 % in the placebo group ( adjusted hazard ratio , 1.0 [ 95 % CI , 0.6 to 1.8 ] ; P = .99 ) at 24 months of age .


The percentage of participants with serious adverse events was 81.4 % [ 57/70 ] of the steroids group and 80.0 % [ 56/70 ] of the placebo group ( P > .99 ) ; however , participants receiving steroids had an earlier time of onset of their first serious adverse event by 30 days posthepatoportoenterostomy ( 37.2 % [ 95 % CI , 26.9 % to 50.0 % ] of steroids group vs 19.0 % [ 95 % CI , 11.5 % to 30.4 % ] of placebo group ; P = .008 ) .


Among infants with biliary atresia who have undergone hepatoportoenterostomy , high-dose steroid therapy following surgery did not result in statistically significant treatment differences in bile drainage at 6 months , although a small clinical benefit could not be excluded .


Steroid treatment was associated with earlier onset of serious adverse events in children with biliary atresia .


clinicaltrials.gov Identifier : NCT00294684 .


A previous randomized , placebo-controlled study showed that infliximab maintenance therapy prevented recurrence of Crohn 's disease 1 year after an ileocolonic resection .


We evaluated recurrence of Crohn 's disease , on the basis of endoscopic examination and/or the need for additional surgical resection , beyond the first postoperative year .


In a prospective , open-label , long-term follow-up study , 24 patients previously randomly assigned to receive infliximab for 1 year after an ileocolonic resection were given the option to continue , stop , or start infliximab therapy .


The primary end point was the time to recurrence of Crohn 's disease , on the basis of endoscopic evidence ( endoscopic recurrence ) , from the initial assignment to postoperative infliximab or placebo .


Secondary end points were rate of endoscopic recurrence , time to reoperation , and rate of surgical recurrence in relation to the total time on infliximab .


All patients were followed for at least 5 years after surgery .


Patients assigned to the infliximab group in the first year after surgery had a longer mean time to first endoscopic recurrence ( 1231 747 days ) than patients originally assigned to the placebo group ( 460 121 days , P = .003 ) .


Colonoscopies identified Crohn 's disease recurrence in 22.2 % of patients who received long-term infliximab and in 93.9 % of those not on infliximab ( P < .0001 ) .


Compared with no infliximab , the adjusted rate ratio for being in endoscopic remission while on infliximab was 13.47 ( 95 % confidence interval , 3.52-61 .53 ; P = .0001 ) .


Patients originally assigned to the infliximab group had a mean longer time to surgery ( 1798 359 days ) than patients originally assigned to the placebo group ( 1058 529 days , P = .04 ) .


The rate of surgical recurrence ( required additional surgical resection ) was significantly lower among patients who received infliximab for most of the follow-up period than patients who received it for shorter periods ( 20.0 % vs 64.3 % , P = .047 ) .


Postoperative infliximab maintenance beyond 1 year prevents recurrence of Crohn 's disease .


A web-based followup assessment may be a feasible , cost-saving alternative of tracking patient outcomes after total joint arthroplasty .


However , before implementing a web-based program , it is important to determine patient satisfaction levels with the new followup method .


Satisfaction with the care received is becoming an increasingly important metric , and we do not know to what degree patients are satisfied with an approach to followup that does not involve an in-person visit with their surgeons .


We determined ( 1 ) patient satisfaction and ( 2 ) patients ' preferences for followup method ( web-based or in-person ) after total joint arthroplasty .


We randomized patients who were at least 12 months after primary THA or TKA to complete a web-based followup or to have their appointment at the clinic .


There were 410 eligible patients contacted for the study during the recruitment period .


Of these , 256 agreed to participate , and a total of 229 patients completed the study ( 89 % of those enrolled , 56 % of those potentially eligible ; 111 in the usual-care group , 118 in the web-based group ) .


Their mean age was 69 years ( range , 38-86 years ) .


There was no crossover between groups .


All 229 patients completed a satisfaction questionnaire at the time of their followup appointments .


Patients in the web-based group also completed a satisfaction and preference questionnaire 1 year later .


Only patients from the web-based group were asked to indicate preference as they had experienced the web-based and in-person followup methods .


We used descriptive statistics to summarize the satisfaction questionnaires and compared results using Pearson 's chi-square test .


Ninety-one patients ( 82.0 % ) in the usual-care group indicated that they were either extremely or very satisfied with the followup process compared with 90 patients ( 75.6 % ) who were in the web-based group ( p < 0.01 ; odds ratio [ OR ] = 3.95 ; 95 % CI , 1.79-8 .76 ) .


Similarly , patients in the usual care group were more satisfied with the care they received from their surgeon , compared with patients in the web-based group ( 92.8 % versus 73.9 % ; p < 0.01 , OR = 1.37 ; 95 % CI , 0.73-2 .57 ) .


Forty-four percent of patients preferred the web-based method , 36 % preferred the usual method , and 16 % had no preference ( p = 0.01 ) .


Our results show moderate to high satisfaction levels with a web-based followup assessment .


Patients who completed the usual method of in-person followup assessment reported greater satisfaction ; however , the difference was small and may not outweigh the additional cost and time-saving benefits of the web-based followup method .


Level I , therapeutic study .


See the Instructions for Authors for a complete description of levels of evidence .


Endocannabinoid system ( ECS ) activation promotes obesity-associated metabolic disease .


Increased dietary fat intake increases blood endocannabinoids and alters adipose and skeletal muscle ECS gene expression in human .


Two weeks isocaloric low - ( LFD ) and high-fat diets ( HFD ) in obese ( n = 12 ) and normal-weight ( n = 17 ) subjects in a randomized cross-over study were compared .


Blood endocannabinoids were measured in the fasting condition and after food intake using mass spectrometry .


Adipose and skeletal muscle gene expression was determined using real-time RT-PCR .


Baseline fasting plasma endocannabinoids were similar with both diets .


Anandamide decreased similarly with high - or low-fat test meals in both groups .


Baseline arachidonoylglycerol plasma concentrations were similar between groups and diets , and unresponsive to eating .


In subcutaneous adipose tissue , DAGL - mRNA was upregulated and fatty acid amide hydrolase ( FAAH ) and monoacylglycerol lipase ( MAGL ) mRNAs were down-regulated in obese subjects , but the diets had no influence .


In contrast , the HFD produced pronounced reductions in skeletal muscle CB1-R and MAGL mRNA expression , whereas obesity did not affect muscular gene expression .


Weight-neutral changes in dietary fat intake can not explain excessive endocannabinoid availability in human obesity .


Obesity and dietary fat intake affect ECS gene expression in a tissue-specific manner .


To study protective effect of ulinastatin on perioperative cardiac function in elderly patients undergoing major gastrointestinal surgery .


Sixty elderly patients ( 32 male and 28 female patients ) aged 60-82 years scheduled for major gastrointestinal surgery were randomized into ulinastatin group and control group .


The patients in ulinastatin group received 210 ( 5 ) U ulinastatin rapidly administered via a intravenous pump immediately before operation with subsequent continuous infusion at the rate of 110 ( 5 ) U until the completion of surgery , and those in the control group received the same amount of saline instead .


In both groups , the mean arterial pressure ( MAP ) , heart rate ( HR ) , left ventricular ejection fraction ( LVEF ) , and cardiac output ( CO ) were monitored immediately before surgery ( T0 ) and at 1 h ( T1 ) , 2 h ( T2 ) and 3 h ( T3 ) after the start of surgery .


The total dopamine dose used was recorded at the end of surgery , and blood samples were collected at T0 and at 6 h ( T4 ) and 12 h ( T5 ) after the operation for determination of serum levels of cTn , CK-MB and BNP .


In both groups , MAP , LVEF and CO were significantly decreased at T2 and T3 ( P < 0.05 ) and serum levels of cTn , CK-MB and BNP significantly increased at T4 and T5 compared to those at T0 ( P < 0.05 ) .


Compared with the control group , the patients in ulinastatin group showed significantly higher MAP , LVEF and CO at T2 and T3 and lower serum levels of cTn , CK-MB and BNP at T4 and T5 .


Ulinastatin offers effective perioerative cardiac protection in elderly patients undergoing major gastrointestinal surgery .


To determine the 12-month cost-effectiveness of a collaborative care ( CC ) program for treating depression following coronary artery bypass graft ( CABG ) surgery versus physicians ' usual care ( UC ) .


We obtained 12 continuous months of Medicare and private medical insurance claims data on 189 patients who screened positive for depression following CABG surgery , met criteria for depression when reassessed by telephone 2 weeks following hospitalization ( nine-item Patient Health Questionnaire 10 ) and were randomized to either an 8-month centralized , nurse-provided and telephone-delivered CC intervention for depression or to their physicians ' UC .


At 12 months following randomization , CC patients had $ 2068 lower but statistically similar estimated median costs compared to UC ( P = .30 ) and a variety of sensitivity analyses produced no significant changes .


The incremental cost-effectiveness ratio of CC was - $ 9889 ( - $ 11,940 to - $ 7838 ) per additional quality-adjusted life-year ( QALY ) , and there was 90 % probability it would be cost-effective at the willingness to pay threshold of $ 20,000 per additional QALY .


A bootstrapped cost-effectiveness plane also demonstrated a 68 % probability of CC `` dominating '' UC ( more QALYs at lower cost ) .


Centralized , nurse-provided and telephone-delivered CC for post-CABG depression is a quality-improving and cost-effective treatment that meets generally accepted criteria for high-value care .


To evaluate the relative pain and the relative amount of contact lens loss experienced using two different base curvatures ( BCs ) of the Acuvue Oasys bandage soft contact lens ( BSCL ) after photorefractive keratectomy ( PRK ) .


One hundred forty patients undergoing PRK on either the Allegretto or the VISX laser at the Joint Warfighter Refractive Surgery Center in Lackland AFB , TX , were randomized to one of the two different BCs of the Acuvue Oasys BSCL : 8.4 or 8.8 mm .


Patients were evaluated on postoperative days 1 and 4 during which they completed a survey rating absolute pain in each eye on a visual analog pain scale .


Lens loss was recorded throughout the study .


Patients treated on the Allegretto laser preferred the 8.4-mm BC lens , whereas comfort after treatment on the VISX depended on corneal shape .


For VISX , patients with very flat corneas ( steep K 42 preoperative or 38 postoperatively ) preferred an 8.8-mm BC lens while patients with very steep corneas ( steep K > 45 preoperative or > 42 postoperative ) preferred an 8.4-mm BC lens , though these results were largely not statistically significant .


Patients who lost their lenses prematurely tended to be those whose corneal curvature did not match their contact lens BC .


Individuals treated with the Allegretto laser or individuals with more prolate corneas should likely be fit with an 8.4-mm BC Acuvue Oasys BSCL while individuals with more oblate corneas should likely be fit with an 8.8-mm BC lens to minimize postoperative pain and premature BSCL loss .


We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection ( STI ) clinics in 3 southern US cities .


In 2010 to 2012 , we screened ( n = 1102 ) and enrolled ( n = 702 ) youths aged 15 to 23 years who identified as Black and reported recent ( past 2 months ) sexual activity and randomized them to a private , brief , interactive intervention ( n = 349 ) or an attention-equivalent control condition ( n = 353 ) .


Assessments occurred at baseline and 2 and 6 months after the intervention .


At 6 months , with adjustment for age and pretest nonequivalence of the outcome variable , an estimated odds ratio ( EOR ) of 1.63 ( 95 % confidence interval [ CI ] = 1.07 , 2.49 ; P = .02 ) indicated efficacy for correct condom use .


An adjusted generalized estimating equations model with both 2 - and 6-month condom use variables produced an EOR of 1.49 ( 95 % CI = 1.06 , 2.08 ; P = .02 ) .


We did not observe significant effects on chlamydia and gonorrhea incidence .


This brief intervention , delivered as part of STI clinical care , could help alleviate the disproportionate STI-HIV burden among young Black men .


Vaso-occlusive episodes ( VOEs ) are the most common complication of sickle cell disease in children .


Treatment with magnesium seems to improve cellular hydration and may result in reduced vaso-occlusion .


This study aimed to determine if intravenous ( IV ) magnesium sulfate ( MgSO4 ) reduces length of stay ( LOS ) in hospital , pain scores , and cumulative analgesia when compared with placebo .


Randomized , double-blind , placebo-controlled trial in children aged 4 to 18 years requiring admission to hospital with a sickle cell disease VOE requiring IV analgesia .


Participating children received IV MgSO4 ( 100 mg/kg ) every 8 hours or placebo in addition to standard therapy .


We used a t test or Mann-Whitney test ( continuous variables ) , Fisher 's exact test , or 2 test ( frequencies ) .


P values were considered significant if < .05 , and 95 % confidence intervals were calculated for the difference between groups .


One hundred six children were randomly assigned to the study , and 104 were included .


Fifty-one ( 49 % ) received MgSO4 .


Children 's mean age was 12.4 years ( range : 4-18 years ; SD : 3.8 years ) , and 56 ( 54 % ) were females .


There was no significant difference in the primary outcome measure , LOS in hospital , with a mean of 132.6 and 117.7 hours in the MgSO4 and placebo groups , respectively ( P = .41 ) .


There was no significant difference between groups for the secondary outcomes of mean pain scores ( 4.9 2.6 vs 4.8 2.6 , respectively ; P = .92 ) or analgesic requirements ( continuous morphine infusion [ P = .928 ] , boluses of IV morphine [ P = .82 ] , acetaminophen [ P = .34 ] , ibuprofen [ P = .15 ] , naproxen [ P = .10 ] ) .


Only minor adverse events were recorded in both groups .


Pain at the infusion site was more common in the MgSO4 group .


IV MgSO4 was well tolerated but had no effect on the LOS in hospital , pain scores , or cumulative analgesia use in admitted children with a VOE .


Detecting paroxysmal atrial fibrillation ( AF ) in patients with ischemic strokes presenting in sinus rhythm is challenging because episodes are often short , occur randomly , and are frequently asymptomatic .


If AF is detected , recurrent thromboembolism can be prevented efficiently by oral anticoagulation .


Numerous uncontrolled studies using various electrocardiogram ( ECG ) devices have established that prolonged ECG monitoring increases the yield of AF detection , but most established procedures are time-consuming and costly .


The few randomized trials are mostly limited to cryptogenic strokes .


The optimal method , duration , and patient selection remain unclear .


Repeated prolonged continuous Holter ECG monitoring to detect paroxysmal AF within an unspecific stroke population may prove to be a widely applicable , effective secondary prevention strategy .


Find-AFRANDOMISED is a randomized and controlled prospective multicenter trial .


Four hundred patients 60 years or older with manifest ( symptoms 24 hours or acute computed tomography/magnetic resonance imaging lesion ) and acute ( symptoms 7 days ) ischemic strokes will be included at 4 certified stroke centers in Germany .


Those with previously diagnosed AF/flutter , indications/contraindications for oral anticoagulation , or obvious causative blood vessel pathologies will be excluded .


Patients will be randomized 1:1 to either enhanced and prolonged Holter ECG monitoring ( 10 days at baseline and after 3 and 6 months ) or standard of care ( 24-hour continuous ECG monitoring , according to current stroke guidelines ) .


All patients will be followed up for at least 12 months .


The primary end point is newly detected AF ( 30 seconds ) after 6 months , confirmed by an independent adjudication committee .


We plan to complete recruitment in autumn 2014 .


First results can be expected by spring 2016 .


Newcomers at high altitude ( > 3,000 m ) experience periodic breathing , sleep disturbances , and impaired cognitive performance .


Whether similar adverse effects occur at lower elevations is uncertain , although numerous lowlanders travel to moderate altitude for professional or recreational activities .


We evaluated the hypothesis that nocturnal breathing , sleep , and cognitive performance of lowlanders are impaired at moderate altitude .


Randomized crossover trial .


University hospital at 490 m , Swiss mountain villages at 1,630 m and 2,590 m.


Fifty-one healthy men , median ( quartiles ) age 24 y ( 20-28 y ) , living below 800 m.


Studies at Zurich ( 490 m ) and during 4 consecutive days at 1,630 m and 2,590 m , respectively , 2 days each .


The order of altitude exposure was randomized .


Polysomnography , psychomotor vigilance tests ( PVT ) , the number back test , several other tests of cognitive performance , and questionnaires were evaluated .


The median ( quartiles ) apnea-hypopnea index at 490 m was 4.6 / h ( 2.3 ; 7.9 ) , values at 1,630 and 2,590 m , day 1 and 2 , respectively , were 7.0 / h ( 4.1 ; 12.6 ) , 5.4 / h ( 3.5 ; 10.5 ) , 13.1 / h ( 6.7 ; 32.1 ) , and 8.0 / h ( 4.4 ; 23.1 ) ; corresponding values of mean nocturnal oxygen saturation were 96 % ( 95 ; 96 ) , 94 % ( 93 ; 95 ) , 94 % ( 93 ; 95 ) , 90 % ( 89 ; 91 ) , 91 % ( 90 ; 92 ) , P < 0.05 versus 490 m , all instances .


Slow wave sleep on the first night at 2,590 m was 21 % ( 18 ; 25 ) versus 24 % ( 20 ; 27 ) at 490 m ( P < 0.05 ) .


Psychomotor vigilance and various other measures of cognitive performance did not change significantly .


Healthy men acutely exposed during 4 days to hypoxemia at 1,630 m and 2,590 m reveal a considerable amount of periodic breathing and sleep disturbances .


However , no significant effects on psychomotor reaction speed or cognitive performance were observed .


Clinicaltrials.gov : NCT01130948 .


Low-volume bowel preparations have been shown to provide an equivalent cleansing effect as that of a standard 4 L polyethylene glycol .


However , studies comparing the efficacy of low-volume bowel preparations are few , and the results have been controversial .


This study aimed to compare the bowel cleansing quality and tolerability between sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid .


A randomized study was performed with two hundred outpatients who were prospectively enrolled .


The Boston Bowel Preparation Scale and the Aronchick scale were used to evaluate the bowel cleansing quality , and bubble scoring was also performed to back up both results .


To investigate patients ' preferences and tolerability , a questionnaire was administered .


Sodium picosulfate/magnesium citrate was not inferior to polyethylene glycol with ascorbic acid in terms of successful bowel preparation ( 6 Boston scale score : 80 % vs. 82 % ; p = 0.718 , adequate Aronchick grade : 93 % vs. 96 % ; p = 0.352 ) .


In addition , sodium picosulfate/magnesium citrate caused fewer gastrointestinal symptoms , and tasted better than polyethylene glycol with ascorbic acid .


Sodium picosulfate/magnesium citrate was not inferior to polyethylene glycol with ascorbic acid in cleansing efficacy , and was found to have higher tolerability .


Multimorbidity and declining performance in elderly cancer patients may result in less treatment benefit .


We investigated whether age is a predictor for pain response and quality of life ( QoL ) after radiotherapy in patients with painful bone metastases .


The database of the Dutch Bone Metastasis Study was used ( 1996-1999 ) .


1157 patients , irradiated for painful bone metastases , rated their pain , QoL-domains and overall health at baseline and during follow-up .


Response was calculated taking into account changes in pain score and medication .


Patients were grouped into three age cohorts : A : < 65 ( n = 520 ) , B : 65-74 ( n = 410 ) and C : 75years ( n = 227 ) .


No significant difference existed in pain response between cohorts : 78 % in cohort A , 74 % in B and 67 % in C.


When assessing baseline QoL , a significant difference in activity level was noticed , with more impairment in elderly compared to younger patients ( C versus B ( p = 0.01 ) , C versus A ( p < 0.001 ) ) .


Other QoL-domains were similar at baseline and during follow-up among cohorts .


A pain response was significantly associated with improvement of health-related QoL ( OR 3.74 , 95 % CI 2.66-5 .25 ) .


The majority of elderly patients with painful bone metastases responded to radiotherapy and showed comparable overall QoL compared to their younger counterparts .


Age is not a predictor for pain response or QoL .


to investigate the efficacy of zinc supplementation in chronic prostatitis treatment .


present randomized clinical trial was conducted on 120 patients with diagnosis of chronic prostatitis ( IIIA NIH ) after preliminary evaluation and ruling out other conditions .


The study group received oral zinc sulfate 220 mg daily as capsule without any other supplements .


The control group received placebo .


Subjects were examined for NIH-CPSI scores every 4 weeks for 12 weeks .


101 subjects completed the study .


There were no statistically significant differences in scores and sub-scores of NIH-CPSI between groups before intervention .


Decline in the score and sub-scores were more prominent in case group after beginning of the study ; though the differences were not statistically significant .


Furthermore , the differences in total score and pain score at 12 weeks follow was statistically significant ( p = 0.003 and p = 0.02 , respectively ) .


zinc supplements may benefit in management of patients with chronic prostatitis NIH-IIIA .


It can be attributable to anti-bacterial and immuno-modulatory functions of organic zinc in the body .


This study sought to examine the effect of statin therapy hospitalizations for heart failure ( HFH ) in patients in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) trial .


HFH is an important , frequently recurrent event .


Conventional time-to-first event analyses do not take account repeat events .


We used a number of statistical approaches to examine the effect of treatment on first and repeat HFH in the CORONA trial .


In the CORONA trial , 5,011 patients 60 years of age with chronic New York Heart Association functional classes II to IV systolic heart failure resulting from ischemia were randomized to receive rosuvastatin or placebo .


Poisson , Andersen-Gill , and negative binomial methods ( NB ) were used to analyze the effect of rosuvastatin on HFH , and the NB and a parametric joint frailty model ( JF ) were used to examine this effect while accounting for the competing risk of cardiovascular ( CV ) death .


Rosuvastatin/placebo rate ratios were calculated , both unadjusted and adjusted .


A total of 1,291 patients had 1 or more HFH ( 750 of these had a single HFH only ) , and there were a total of 2,408 HFHs .


The hazard ratio for the conventional time-to-first event analysis for HFH was 0.91 ( 95 % confidence interval [ CI ] : 0.82 to 1.02 , p = 0.105 ) .


In contrast , the NB on repeat hospitalizations gave an unadjusted RR ( RR ) for HFH of 0.86 ( 95 % CI : 0.75 to 0.99 , p = 0.030 ) , adjusted 0.82 ( 95 % CI : 0.72 to 0.92 , p = 0.001 ) , and after including CV death as the last event , adjusted RR of 0.85 ( 95 % CI : 0.77 to 0.94 , p = 0.001 ) .


The JF gave an adjusted RR of 0.82 ( 95 % CI : 0.73 to 0.92 , p = 0.001 ) .


Similar results were found in analyses of all CV hospitalizations and all-cause hospitalizations .


When repeat events were included , rosuvastatin was shown to reduce the risk of HFH by approximately 15 % to 20 % , equating to approximately 76 fewer admissions per 1,000 patients treated over a median 33 months of follow-up .


Including repeat events could increase the ability to detect treatment effects in heart failure trials .


To determine agreement between spectral-domain ( SD ) and time-domain ( TD ) optical coherence tomography ( OCT ) image assessments by certified readers in eyes treated for neovascular age-related macular degeneration ( AMD ) .


Cross-sectional study within the Comparison of AMD Treatments Trials ( CATT ) .


During year 2 of CATT , 1213 pairs of SD OCT and TD OCT scans were compared from a subset of 384 eyes .


Masked readers independently graded OCT scans for presence of intraretinal fluid ( IRF ) , subretinal fluid ( SRF ) , and sub-retinal pigment epithelium ( RPE ) fluid and performed manual measurements of retinal , SRF , and subretinal tissue complex thicknesses at the foveal center .


Presence of fluid was evaluated with percent agreement , coefficients with 95 % confidence intervals ( CIs ) , and McNemar tests .


Thickness measurements were evaluated with mean difference ( ) 95 % limits of agreement and intraclass correlation coefficients ( ICCs ) with 95 % CIs .


Between SD OCT and TD OCT , agreement on presence of any fluid was 82 % ( = 0.46 ; 95 % CI , 0.40-0 .52 ) , with 5 % more SD OCT scans demonstrating fluid ( P < 0.001 ) .


Agreement on presence of SRF was 87 % and sub-RPE fluid was 80 % , with more SD OCT scans demonstrating fluid ( both P < 0.001 ) .


Agreement on IRF was 73 % ( = 0.47 ; 95 % CI , 0.42-0 .52 ) , with 6 % more TD OCT scans demonstrating fluid ( P < 0.001 ) .


Between SD OCT and TD OCT , mean thickness of the retina was = 567 m , SRF was = 1.535 m , and subretinal tissue complex was = 586 m. Thickness measurements were reproducible for retina ( ICC = 0.84 ; 95 % CI , 0.83-0 .86 ) , SRF ( ICC = 0.88 ; 95 % CI , 0.86-0 .89 ) , and subretinal tissue complex ( ICC = 0.91 ; 95 % CI , 0.89-0 .92 ) , with 25-m difference in these measurements in 71 % , 94 % , and 61 % of paired scans , respectively .


Agreement on fluid presence and manual thickness measurements between paired scans from each OCT modality was moderate , providing a reasonable basis to compare CATT results with future SD OCT-based trials .


Fluid was detected 5 % more frequently with SD OCT , which may increase frequency of fluid-based treatment .


Lower-resolution and artifactual interpretation of dark areas as cystoid edema may explain the greater frequency of IRF detected with TD OCT. .


To evaluate the cost-effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared to general practitioners ' care .


A multicentre randomised trial with 175 community dwelling patients newly diagnosed with mild to moderate dementia , and their informal caregivers , with twelve months ' follow-up .


Cost-effectiveness was evaluated from a societal point of view and presented as incremental cost per quality adjusted life year .


To establish cost-effectiveness , a cost-utility analysis was conducted using utilities based on the EQ-5D .


Uncertainty surrounding the incremental cost-effectiveness ratio ( difference in costs divided by difference in effects ) was calculated by bootstrapping from the original data .


Compared to general practitioners ' care , treatment by the memory clinics was on average 1024 ( 95 % CI : -7723 to 5674 ) cheaper , and showed a non-significant decrease of 0.025 ( 95 % CI : -0.114 to 0.064 ) quality adjusted life years .


The incremental cost-effectiveness point estimate from the bootstrap simulation was 41 442 per QALY lost if one would use memory clinic care instead of general practitioner care .


No evidence was found that memory clinics were more cost-effective compared to general practitioners with regard to post-diagnosis treatment and coordination of care of patients with dementia in the first year after diagnosis .


ClinicalTrials.gov NCT00554047 .


Methotrexate ( MTX ) is recognised as the cornerstone of treatment for rheumatoid arthritis .


For some patients , oral MTX demonstrates variable bioavailability , especially at higher doses .


Such concerns may be mitigated by subcutaneous ( SC ) MTX administration .


This study investigated the relative bioavailability , safety , and tolerability of MTX administered either by SC injection with a prefilled autoinjector pen ( MTX pen ) or orally .


This single-centre , open-label , randomised , 2-period , 2-sequence , single-dose , crossover study enrolled healthy subjects aged 18 to 55 years into 1 of 4 dose groups ( 7.5 mg , 15 mg , 22.5 mg , and 30 mg ) , where they received a single dose of SC MTX and of the oral MTX tablets .


Blood samples were collected from subjects predose and at prespecified time points postdose for pharmacokinetic analyses .


Adverse events ( AEs ) were recorded to assess differences in safety and tolerability .


Bioavailability , as measured by maximum plasma concentrations ( Cmax ) and area under the plasma-concentration curves ( AUC0-t ) , was generally higher with the SC MTX pen compared with oral administration for all dose groups .


AUC0-t ratios increased with ascending doses ; Cmax ratios did not increase .


A total of 80 AEs were reported in 35/62 subjects ; none were severe .


Differences in the safety profiles were related to the route of administration .


Single administrations with the MTX pen were well tolerated at the injection site .


Single-dose administration with the SC MTX pen resulted in a higher relative bioavailability compared with oral administration .


SC MTX pen administration was associated with fewer gastrointestinal AEs than oral MTX .


Degenerative spondylolisthesis is a well-recognized source of low back pain mainly induced by facet joint pain .


Pulsed radiofrequency ( PRF ) allows heat dissipation , thus producing a temporary injury that affects only type C fibers responsible for pain conduction .


We attempted to test whether PRF is a better choice for facet pain due to spondylolisthesis compared to routine steroid injection .


Patients were randomly assigned to one of two groups : group one received pulsed RF , and group 2 received injection by steroids ( triamcinolone ) and bupivacaine .


Multiple outcome measures were utilized which included the numeric rating scale ( NRS ) , the Oswestry Disability Index ( ODI ) , satisfaction status , and analgesic intake with assessment at 3 , 6 , and 12 months post-treatment .


Significant pain relief was defined as 50 % or more , whereas significant improvement in disability score was defined as reduction of 40 % or more .


Eighty patients were enrolled in the study and were divided into the two groups of study .


PRF significantly reduced NRS at 6-month follow-up compared to steroid + bupivacaine .


75.6 14.3 % at pre-treatment and 19.3 9.5 % at 6 months ( p = 0.001 ) in PRF group .


The mean ODI is depicted in two groups of study ( Fig. 1 ) .


Interestingly , ODI % was significantly lower in PRF group at 12 weeks and 6 months compare to steroid + bupivacaine group ( p = 0.022 and 0.03 , respectively ) , but it was not significantly different at 6 weeks ( p = 0.31 ) .


Proportion of patients who did not require analgesics were significantly higher in PRF group compared to other group ( p = 0.001 ) in Log-rank ( Mantel-Cox ) test .


Our results demonstrated that the application of PRF might be more effective than steroid and bupivacaine injection in decreasing back pain due to degenerative facet pain and improvement in function of patients .


To evaluate if ibuprofen 800mg reduces pain with intrauterine device ( IUD ) insertion among U.S. women .


We conducted a randomized , double-blind , placebo-controlled trial of women undergoing IUD insertion approximately 2-6weeks following first-trimester uterine aspiration .


Subjects were randomized to receive ibuprofen 800mg or placebo 30-45min prior to IUD insertion .


A 100-mm visual analog scale ( VAS ) was administered to measure pain after speculum insertion ( baseline ) and immediately following IUD insertion .


A total of 202 women were enrolled , with 101 randomized to each group ( ibuprofen or placebo ) .


Sociodemographic characteristics and baseline VAS scores were similar between groups .


The median pain score with IUD insertion was 41.5 mm in the placebo group and 38.0 mm in the ibuprofen group ( p = .50 ) .


Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently .


Overall , median pain scores were 17.5 mm higher in nulliparous women than parous women ( p = .004 ) .


Median pain scores did not differ by age , IUD-type , history of dysmenorrhea or time since aspiration .


Administration of ibuprofen 800mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women .


Overall , nulliparous women report more pain with IUD insertion than multiparous women .


This prospective randomized controlled trial was conducted to compare the safety , tolerability and outcome of early oral feeding vs. traditional feeding in patients undergoing elective open bowel surgery .


A total of 120 consecutive patients who underwent elective open bowel surgeries were randomized into either early feeding ( n = 60 ) or traditional feeding group ( n = 60 ) .


Patients in the early feeding group were started on oral fluids on post-operative day 1 , while those in the traditional feeding group were started orals after the resolution of ileus .


Patient characteristics , surgical procedures , co-morbidity , first flatus , first defecation , time of starting solid diet , complications and length of hospitalization were assessed between the two groups .


The two groups were similar in demographic and baseline data .


The number of days to first flatus ( p < 0.0001 ) , first defecation ( p < 0.0001 ) , length of post-operative stay ( p = 0.011 ) and time of starting solid diet ( p < 0.0001 ) were significantly earlier in the early feeding group .


Anastomotic leak , wound infection , fever , vomiting , abdominal distention and other complications were similar .


Multivariate analysis showed that patients in the early oral feeding group were discharged 3.4 days earlier ( p = 0.037 ) .


In patients undergoing elective open bowel surgeries , early post-operative feeding is safe , is well tolerated and reduces the length of hospitalization .


The aim of the present study was to determine the effectiveness of parent manipulation on newborns with postural clubfoot , as compared to newborns that receive no treatment in a randomized controlled trial .


Ninety-two healthy newborns , including 40 boys and 52 girls , ( 169 postural clubfeet , including 77 with bilaterally involvement ) were included and categorized into two groups by simple randomization using the sealed opaque envelope technique .


In Group A , the parent manipulation group , there were 14 boys and 33 girls in 85 postural clubfeet with 38 bilateral involvements .


Manipulations were performed at least 20 times per day and the stimulation of the newborn 's foot / feet byparent finger was performed at least 100 times per day .


In Group B , the group of newborns receiving no treatment , there were 26 boys and 19 girls in 84 postural clubfeet with 39 bilateral involvements .


The follow-up periods for both groups were one , three , and four months after starting the manipulation .


The success of the manipulation was measured by the foot appearance , which was normally performed by physical examination .


A comparison of the characteristics of newborns and parents in both groups showed no statistical differences , except the sex of the newborn .


All newborns in both groups were one to six days old .


The success rate after 4 months of manipulation in Group A was 71.8 % , but it was 81 % in Group B with no manipulation ; results indicate no statistically significant difference ( p = 0.16 ) .


The severity of the postural clubfeet indicated no statistical difference in the results of either group ( p = 0.3 ) .


All cases were followed up at one year with 14 % of the studyparticipants dropping out in Group A and 11 % dropping out of the study in Group B. All postural clubfeet disappeared in every case within one year of birth except one case in Group A that required casting and one case in Group B that required a prescription for orthopaedic shoes .


No clinical or statistical differences were found between newborns who received parent manipulation for the treatment of postural clubfoot and newborns who received no treatment .


Spontaneous recovery occurred in most of the cases within four months of birth or not more than one year after birth .


The aim of this trial was to investigate the effect of therapeutic microwave diathermy ( MD ) on pain , disability , trunk muscle strength , walking performance , mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) .


A total of 39 patients were included in this study .


The patients were randomized into two groups .


Group 1 ( n = 19 ) received MD treatment and exercises .


Group 2 ( n = 20 ) was given only exercises .


The pain ( visual analog scale ) , disability ( Oswestry Disability Questionnaire and pain disability index ) , walking performance ( 6 minute walking test , 6MWT ) , depression and QOL ( Short Form 36 ) of all participants were evaluated .


Patients were assessed before treatment ( BT ) , after treatment ( AT ) , and at a 1-month follow-up ( F ) .


The patients with CLBP in each group had significant improvements in pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression AT and F when compared with their initial status .


There was no statistically significant difference between the groups regarding the change scores between AT-BT test and F-BT test .


Since a 2,450-MHz MD showed no beneficial effects on clinical parameters , exercise program could be preferable for the treatment of patients with CLBP alone .


Exercise intolerance is a common development in patients with chronic obstructive pulmonary disease ( COPD ) .


There is little data on the use of an isolated program using vibration platform training on functional capacity in these patients , which is an area that deserves investigation .


To investigate the effect of training on a vibrating platform ( whole-body vibration [ WBV ] ) on functional performance and quality of life of subjects with COPD .


A randomized controlled crossover pilot study with eleven subjects with COPD ( forced expiratory volume in 1 second [ FEV1 ] % predicted = 14.6311.14 ; forced vital capacity [ FVC ] % predicted = 48.8415.21 ; FEV1/FVC = 47.3911.63 ) underwent a 12-week WBV training program .


Participants were randomized into the intervention group ( IG ) undergoing three sessions per week for a total of 12 weeks and control group ( CG ) without intervention .


We evaluated the 6-minute walk test ( 6MWT ) , distance walked ( DW ) , duration of the walk ( TW ) , and index of perceived exertion ( IPE ) , quality of life using St George 's Respiratory Questionnaire ( SGRQ ) and developed a 12-week program of training on a vibrating platform .


The mean age was 62.918.82 years old ( 72.7 % male ) .


The DW increased at the end of training with a difference between groups of 75 m ; all domains of the SGRQ improved at the end of training .


The effect size Cohen 's d ranged from small to large for all the measured results .


These preliminary results suggest that WBV may potentially be a safe and feasible way to improve functional capacity in the 6MWT of patients with COPD undergoing a training program on the vibrating platform as well as in all domains of the SGRQ quality of life .


However , further studies with a larger number of patients are needed to establish the long-term effect on functional capacity and quality of life in these patients .


Insomnia is prevalent among patients with knee osteoarthritis ( OA ) .


Research indicates that sleep disruption may amplify clinical pain by altering central pain modulation , suggesting that treatment of insomnia may improve pain .


The aims of this study were to evaluate the efficacy of cognitive-behavioral therapy for insomnia ( CBT-I ) in patients with knee OA , to determine whether improvements in sleep predict reduced pain , and to determine whether alterations in pain modulation mediate improvements in clinical pain .


We conducted a randomized , double-blind , active placebo-controlled clinical trial of CBT-I in 100 patients with knee OA and insomnia ( meanSD age 59.49.5 years ) .


Patients were randomized ( 1:1 ) to receive either 8 sessions of CBT-I or behavioral desensitization ( placebo ) .


We conducted in-home polysomnography ( PSG ) , diary assessment , and sensory tests of pain modulation at baseline , posttreatment , 3 months , and 6 months .


Intent-to-treat analyses demonstrated substantial improvement in sleep in both groups of patients .


Patients in the CBT-I group had significantly greater reductions in wake after sleep onset ( WASO ) , as measured by patient diary and PSG .


Patients in both groups reported significant and comparable reductions in pain over 6 months , with one-third reporting a 30 % reduction in pain severity .


Baseline-to-posttreatment reductions in WASO as measured by diary and PSG predicted subsequent decreases in clinical pain .


This effect was significantly greater for CBT-I compared with behavioral desensitization .


No significant changes in laboratory measures of pain modulation were observed .


Compared with active placebo , CBT-I was efficacious in reducing sleep maintenance insomnia .


CBT-I decreased clinical pain , but not pain modulation , suggesting that it has the potential to augment pain management in knee OA .


Future work is needed to identify the mechanisms by which improved sleep reduces clinical pain .


The aim of our study was to characterize the neurophysiologic outcomes in a randomized clinical trial comparing local corticosteroid injection and decompressive surgery in idiopathic carpal tunnel syndrome .


Clinical and neurophysiologic assessments were done at baseline and 12 months after treatment .


Four parameters were evaluated in the nerve conduction study ( NCS ) : distal motor latency , motor amplitude , sensory conduction velocity and sensory amplitude .


Statistic signification was established by the Student 's t test , independent and paired samples , and Mann-Whitney test .


Repeated measures analysis of variance was used by the three domains of symptoms .


Correlations between the changes showed in clinical parameters and those evidenced by electromyography were calculated by the Pearson 's test .


Both groups of therapy were comparable at baseline .


In 95 wrists , a second NCS was done 12 months post-treatment .


Although clinical outcome improved in a similar way in both groups , we found statistically significant improvement in three ( distal motor latency , sensory conduction velocity and sensory amplitude ) of four neurophysiologic parameters only in the surgery group , when compared to baseline values .


Although local corticosteroid injection and decompressive surgery are clinically effective in reducing symptoms of carpal tunnel syndrome , only surgery results in an improvement of the neurophysiologic parameters , at 12-months follow-up .


Only decompressive surgery allows resolution of neurophysiologic changes .


The symptoms of the syndrome are resolved with corticosteroid injections .


To compare changes of heart rate and blood pressure in patients that underwent LMA anesthesia with VIMA or TIVA technique .


A hundred healthy patients , age 16 to 60 years were enrolled .


They were randomized into two groups .


Patients in group V ( VIMA ) were induced with 8 % sevoflurane until loss of eyelash reflexes then controlled ventilation for five minutes before LMA insertion .


Group T ( TIVA ) patients were given propofol to reach the affected site concentration of eight mcg/mlfor the LMA insertion .


Bloodpressure and heart rate were recorded before induction , immediately before and after LMA insertion then every two minutes until surgical incision .


Decreased SBP from baseline in group T was significantly more than group V in each period of time ( D1-D7 ) .


DBP in group T decreased more than group V significantly only at eight and ten minutes after LMA insertion .


The incidence of decreasing SBP > 20 % from baseline was more significant in group T than group V. No significant difference of changed HR was found .


Coughing during LMA insertion occurred in eight patients ( 16 % ) in group T and in three patients ( 6 % ) in group V ( p = 0.11 ) .


Induction with propofol by effective site concentration of eight mcg/ml significantly decreased SBP more than with 8 % sevoflurane .


Both techniques provided smooth LMA insertion without serious complication .


Postpartum haemorrhage can lead to iron deficiency with and without anaemia , the clinical consequences of which include physical fatigue .


Although oral iron is the standard treatment , it is often associated with gastrointestinal side effects and poor compliance .


To date , no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage .


In a single centre , open-labelled , randomised trial , women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care .


Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health ( Multidimensional Fatigue Inventory , Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire ) , at inclusion and at follow-up visits after three days , one week , three weeks , eight weeks , and 12 weeks postpartum .


The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum , as measured by a subscale of the Multidimensional Fatigue Inventory .


The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority , we set the minimal clinically relevant difference between the mean scores at 1.8 , and the assumed standard deviation at 4.2 .


Hence , 87 participants per treatment group are needed in order to demonstrate superiority ; to provide an extra margin for missing data and dropouts , 200 women will be included .


The study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage .


This trial is registered with Clinicaltrials.gov ( identifier : NCT01895218 ) on 26 June 2013 .


The effect of vitamin D on muscle strength in adults is not established .


Our objective was to test whether vitamin D supplementation increases muscle strength and power compared with placebo .


We conducted a randomized , double-blind , placebo-controlled trial .


The setting was immigrants ' activity centers .


Two hundred fifty-one healthy adult males and females aged 18-50 years with non-Western immigrant background performed the baseline test and 86 % returned to the follow-up test .


Sixteen weeks of daily supplementation with 25 g ( 1000 IU ) vitamin D3 , 10 g ( 400 IU ) vitamin D3 , or placebo .


Difference in jump height between pre - and postintervention .


Secondary outcomes were differences in handgrip strength and chair-rising test .


Percentage change in jump height did not differ between those receiving vitamin D ( 25 or 10 g vitamin D3 ) and those receiving placebo ( mean difference -1.4 % , 95 % confidence interval : -4.9 % to 2.2 % , P = .44 ) .


No significant effect was detected in the subgroup randomized to 25 g vitamin D or in other preplanned subgroup analyses nor were there any significant differences in handgrip strength or the chair-rising test .


Mean serum 25-hydroxyvitamin D3 concentration increased from 27 to 52 nmol/L and from 27 to 43 nmol/L in the 25 and 10 g supplementation groups , respectively , whereas serum 25-hydroxyvitamin D3 did not change in the placebo group .


Daily supplementation with 25 or 10 g vitamin D3 for 16 weeks did not improve muscle strength or power measured by the jump test , handgrip test , or chair-rising test in this population with low baseline vitamin D status .


To evaluate the influence of stroke volume variation ( SVV ) - based goal-directed therapy ( GDT ) on splanchnic organ functions and postoperative complications in orthopedic patients .


Eighty patients scheduled for major orthopedic surgery under general anesthesia were randomly allocated to one of two equal groups to receive either intraoperative volume therapy guided by SVV ( GDT ) or standard fluid management ( control ) .


In the SVV group , patients received colloid boluses of 4 ml/kg to maintain an SVV < 10 % when in the supine position or an SVV < 14 % if prone .


In the control group , fluids were given to maintain a mean arterial pressure > 65 mm Hg , a heart rate < 100 bpm , a central venous pressure of 8-14 mm Hg , and a urine output > 0.5 ml/kg/h .


Intraoperative organ perfusion , hemodynamic data , hospitalization , postoperative complications , and mortality were recorded .


The heart rate at the end of surgery was significantly lower ( p < 0.05 ) , there were fewer hypotensive episodes ( p < 0.05 ) , the arterial and gastric intramucosal pH were higher ( p < 0.05 for both ) , the gastric intramucosal PCO2 was lower ( p < 0.05 ) , the intraoperative infused colloids and the total infused volume were lower ( p < 0.05 for both ) , and the postoperative time to flatus was shorter ( p < 0.05 ) in the GDT group than in the control group .


No differences in the length of hospital stay , complications , or mortality were found between the groups .


SVV-based GDT during major orthopedic surgery reduced the volume of the required intraoperative infused fluids , maintained intraoperative hemodynamic stability , and improved the perioperative gastrointestinal function .


To estimate the effectiveness of office-based bipolar radiofrequency ablation compared with thermal balloon ablation of the endometrium for the treatment of heavy menstrual bleeding at 5-year follow-up .


A single blind randomized controlled trial was conducted in an office hysteroscopy clinic in a university teaching hospital .


A total of 81 women were randomly allocated to either bipolar radiofrequency ablation or thermal balloon ablation in an office setting avoiding use of general anesthesia or conscious sedation .


The primary outcome for the trial was amenorrhea at 6 months follow-up .


In this planned secondary analysis , the main outcome measures were amenorrhea rates , patient satisfaction , health-related quality of life , and incidence of further uterine surgery at 5-year follow-up .


At 5-year follow-up , 59 ( 73 % ) women responded to postal questionnaires .


Amenorrhea was reported in 60 % of thermal balloon ablation and 62 % of bipolar radiofrequency ablation ( odds ratio [ OR ] 1.09 [ 0.38-3 .11 ] ) and satisfaction with treatment outcome in 96 % of thermal balloon ablation and 96 % of bipolar radiofrequency ablation ( OR 0.92 [ 0.05-25 .59 ] ) .


Further surgical intervention was needed in three of 29 ( 10 % ) women treated with bipolar radiofrequency ablation compared with four of 30 ( 13 % ) of women treated with thermal balloon ablation ( P = .7 ) .


There was no significant difference in either condition-specific or generic health-related quality-of-life measures .


There was no difference in the effectiveness of bipolar radiofrequency ablation and thermal balloon ablation performed in an office setting at 5-year follow-up .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01124357 .


I.


Evidence supports a role of 42 receptors in Alzheimer 's disease ( AD ) .


This Korean , multicenter , double-blind , two-period ( 6 weeks each ) , crossover study randomized participants to the order in which they received varenicline ( 1 mg twice daily ) and placebo .


Assessments included AD Assessment Scale-Cognitive Subscale ( ADAS-Cog ) 75 , Neuropsychiatric Inventory ( NPI ) , adverse events ( AEs ) and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .


For varenicline versus placebo ( n = 66 randomized ) , there was no significant difference in the week 6 least square ( LS ) mean ADAS-Cog 75 total score ( primary endpoint ; 18.07 vs. 18.49 ; p = 0.3873 ) and a slight worsening in the week 6 LS mean NPI ( 3.82 vs. 2.55 ; p = 0.0468 ) , primarily driven by decreased appetite/eating .


Common treatment-related AEs were nausea ( 23.3 ; 3.4 % ) , vomiting ( 15.0 % ; 0 ) and decreased appetite ( 15.0 ; 6.8 % ) .


Varenicline did not improve cognition , behavior or global change in this population .


The most frequent varenicline-associated AEs were gastrointestinal ; psychiatric AEs were rare and similar between the groups .


Socioeconomic disadvantage is associated with shorter adult stature .


Few studies have examined socioeconomic differences in stature from birth to childhood and the mechanisms involved , particularly in middle-income former Soviet settings .


The sample included 12,463 Belarusian children ( 73 % of the original cohort ) born in 1996-1997 , with up to 14 stature measurements from birth to 7 years .


Linear spline multi-level models with 3 knots at 3 , 12 and 34 months were used to analyse birth length and growth velocity during four age-periods by parental educational achievement ( up to secondary school , advanced secondary/partial university , completed university ) and occupation ( manual , non-manual ) .


Girls born to the most ( versus least ) educated mothers were 0.43 cm ( 95 % confidence interval ( CI ) : 0.28 , 0.58 ) longer at birth ; for boys , the corresponding difference was 0.30 cm ( 95 % CI : 0.15 , 0.46 ) .


Similarly , children of the most educated mothers grew faster from birth-3 months and 12-34 months ( p-values for trend 0.08 ) , such that , by age 7 years , girls with the most ( versus least ) educated mothers were 1.92 cm ( 95 % CI : 1.47 , 2.36 ) taller ; after controlling for urban/rural and East/West area of residence , this difference remained at 1.86 cm ( 95 % CI : 1.42 , 2.31 ) , but after additionally controlling for mid-parental height , attenuated to 1.10 cm ( 95 % CI : 0.69 , 1.52 ) .


Among boys , these differences were 1.95 cm ( 95 % CI : 1.53 , 2.37 ) , 1.89 cm ( 95 % CI : 1.47 , 2.31 ) and 1.16 cm ( 95 % CI : 0.77 , 1.55 ) , respectively .


Additionally controlling for breastfeeding , maternal smoking and older siblings did not substantively alter these findings .


There was no evidence that the association of maternal educational attainment with growth differed in girls compared to boys ( p for interaction = 0.45 ) .


Results were similar for those born to the most ( versus least ) educated fathers , or who had a parent with a non-manual ( versus manual ) occupation .


In Belarus , a middle-income former Soviet country , socioeconomic differences in offspring growth commence in the pre-natal period and generate up to approximately 2 cm difference in height at age 7 years .


These associations are partly explained by genetic or other factors influencing parental stature .


Current Controlled Trials : NCT01352247 assigned 9 Sept 2005 ; ClinicalTrials.gov .


Identifier : NCT01561612 received 20 Mar 2012 .


To determine whether severe intraoperative floppy iris syndrome ( IFIS ) is more or equally likely with tamsulosin or alfuzosin .


Prospective , masked , multicenter , cross-sectional study .


Consecutive patients taking systemic tamsulosin or alfuzosin and scheduled for routine cataract surgery ( case group ) and patients with no history of systemic 1-antagonists scheduled for routine cataract surgery ( control group ) .


Phacoemulsification with intraocular lens implantation was performed and recorded on video .


Intracameral phenylephrine or epinephrine , either by direct injection or placement in the irrigation bottle , was not permitted .


Every surgical video subsequently was reviewed remotely by 2 masked investigators who diagnosed the presence or absence of IFIS and graded the severity of IFIS as follows : none , mild ( billowing only ) , moderate ( billowing and either iris prolapse or 2 mm of pupil constriction ) , or severe ( billowing accompanied by iris prolapse and 2 mm of pupil constriction ) .


Rate and severity of IFIS and surgical complication rate .


A total of 226 eyes ( 70 in the tamsulosin group , 43 in the alfuzosin group , and 113 in the control group ) were enrolled .


Severe IFIS was noted in 34.3 % ( 24/70 ) of the tamsulosin eyes and in 16.3 % ( 7/43 ) of the alfuzosin eyes compared with 4.4 % ( 5/113 ) of the control eyes .


The differences between each of the 3 groups were statistically significant .


In the absence of epinephrine in the irrigation bottle , 12.4 % of control eyes had moderate to severe IFIS .


There were no instances of posterior capsular rupture or significant surgical complications in either the case or control groups .


Moderate to severe IFIS can occur in low-risk eyes when epinephrine is omitted from the irrigation bottle .


Although both tamsulosin and alfuzosin significantly increase the risk of IFIS compared with patients without prior 1-antagonist intake , severe IFIS statistically was more likely with tamsulosin than with alfuzosin ( P = 0.036 ) .


Patients with symptomatic benign prostatic hyperplasia and cataracts requiring a uroselective 1-antagonist may consider trying alfuzosin first .


Jet injectors allow needle-free insulin delivery .


The study objective was to compare the tolerability and device preference of subcutaneous insulin aspart delivery by jet injector ( InsuJet ; European Pharma Group , Schiphol-Rijk , The Netherlands ) with pen injection in an open-label , randomized , crossover pilot study .


Ten participants with type 1 diabetes underwent two meal tolerance tests 1 week apart .


Plasma glucose and serum insulin levels were sampled from 10 min preceding to 240 min after insulin aspart administration by InsuJet or FlexPen ( ) ( Novo Nordisk Pharmaceuticals Pty. Ltd. , Baulkham Hills , NSW , Australia ) .


Insulin dose was calculated using participants ' insulin-to-carbohydrate ratios .


Immediately after insulin administration , participants drank 500 mL of Ensure ( ) ( Abbott Australasia Pty. Ltd. , Botany , NSW , Australia ) ( providing 2,240 kJ of energy , 18.6 g of protein , 96 g of carbohydrate , and 3 g of fat ) .


In this small pilot study , the devices were similar in glucose excursion ( median [ quartile 1 , quartile 3 ] , InsuJet vs. FlexPen , 9.4 [ 4.8 , 12.8 ] vs. 8.1 [ 5.4 , 10.6 ] mmol/L ; P = 0.43 ) , in the area under the glucose concentration-time curve for 0-240 min corrected for baseline glucose level ( InsuJet vs. FlexPen , 1,230 [ 623 , 2,012 ] vs. 1,175 [ 91 , 1,774 ] mmol min/L ; P = 0.4 ) , and in insulin absorption over the 240-min period .


Devices were similar for participant preference and relative injection pain .


Subcutaneous jet injection of aspart insulin was well tolerated .


Malnutrition in head and neck cancer ( HNC ) patients decreases survival , quality of life ( QOL ) and oncological outcomes .


The aim of the prospective three-year study was to compare QOL , clinical symptoms and variables ( complications , survival and mortality rates in HNC patients ) .


A total of 726 patients aged 55 to 72 years with treatable HNC were included from January 2004 to December 2009 ; these patients were randomized to either group with PEG and enteral nutrition and nonPEG group with nutritional counselling according to nutritional care .


We used EORTC questionnaires QOL C-30 and Head and neck module ( HN-35 ) for measuring of QOL .


The following variables due to expectable influence on QOL ( demographic data , oncological data , nutritional screening , Clinical symptom score , Karnofsky performance status score , Charlson comorbidity index ) were included .


Monitoring was done five times in three years .


In the first six months , we found decrease of weight and body mass index ( BMI ) .


After this critical time point and finish of oncological treatment , a marked difference in the development of patients treated with PEG .


Negative factors influencing patients survival , QOL , clinical status were males aged > 63 years , hypopharyngeal cancer ( stage III-IV ) , smoking , weight loss > 10 % , BMI < 21 and disallowance of PEG .


QOL is an essential factor for cancer patients .


Our study showed that nutritional intervention with early enteral nutrition may improve QOL and survival in HNC patients .


The PEG group better tolerated oncological treatment , had lower incidence of complications , shorter time to re-entry of permanent increase in weight , lower rate of rehospitalization and its shorter length .


We found QOL questionnaires to be very important for better understanding and communication and a key instrument for improving solution of patients difficulties during their therapy in multidisciplinary approach .


Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline , a strong risk factor for development of dementia .


Epidemiologic studies suggest that a Mediterranean diet , an antioxidant-rich cardioprotective dietary pattern , delays cognitive decline , but clinical trial evidence is lacking .


To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet .


Parallel-group randomized clinical trial of 447 cognitively healthy volunteers from Barcelona , Spain ( 233 women [ 52.1 % ] ; mean age , 66.9 years ) , at high cardiovascular risk were enrolled into the Prevencin con Dieta Mediterrnea nutrition intervention trial from October 1 , 2003 , through December 31 , 2009 .


All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study .


Participants were randomly assigned to a Mediterranean diet supplemented with extravirgin olive oil ( 1 L/wk ) , a Mediterranean diet supplemented with mixed nuts ( 30 g/d ) , or a control diet ( advice to reduce dietary fat ) .


Rates of cognitive change over time based on a neuropsychological test battery : Mini-Mental State Examination , Rey Auditory Verbal Learning Test ( RAVLT ) , Animals Semantic Fluency , Digit Span subtest from the Wechsler Adult Intelligence Scale , Verbal Paired Associates from the Wechsler Memory Scale , and the Color Trail Test .


We used mean z scores of change in each test to construct 3 cognitive composites : memory , frontal ( attention and executive function ) , and global .


Follow-up cognitive tests were available in 334 participants after intervention ( median , 4.1 years ) .


In multivariate analyses adjusted for confounders , participants allocated to a Mediterranean dietplus olive oil scored better on the RAVLT ( P = .049 ) and Color Trail Test part 2 ( P = .04 ) compared with controls ; no between-group differences were observed for the other cognitive tests .


Similarly adjusted cognitive composites ( mean z scores with 95 % CIs ) for changes above baseline of the memory composite were 0.04 ( -0.09 to 0.18 ) for the Mediterranean diet plus olive oil , 0.09 ( -0.05 to 0.23 ; P = .04 vs controls ) for the Mediterranean diet plus nuts , and -0.17 ( -0.32 to -0.01 ) for the control diet .


Respective changes from baseline of the frontal cognition composite were 0.23 ( 0.03 to 0.43 ; P = .003 vs controls ) , 0.03 ( -0.25 to 0.31 ) , and -0.33 ( -0.57 to -0.09 ) .


Changes from baseline of the global cognition composite were 0.05 ( -0.11 to 0.21 ; P = .005 vs controls ) for the Mediterranean diet plus olive oil , -0.05 ( -0.27 to 0.18 ) for the Mediterranean diet plus nuts , and -0.38 ( -0.57 to -0.18 ) for the control diet .


All cognitive composites significantly ( P < .05 ) decreased from baseline in controls .


In an older population , a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function .


isrctn.org Identifier : ISRCTN35739639 .


To evaluate the effect of transcutaneous electrical acupuncture point stimulation ( TEAS ) on endometrial HOXA10 protein expression and three-dimensional ( 3D ) power Doppler ultrasound parameters as markers of endometrial receptivity in women undergoing frozen-thawed embryo transfer ( FET ) .


A total of 68 women undergoing FET were randomised to receive TEAS or mock TEAS at acupuncture points CV3 , CV4 and SP6 and Zigong bilaterally .


Both groups had six sessions per cycle for three menstrual cycles prior to the scheduled FET .


Each session lasted 30min and was repeated every other day .


3D power Doppler ultrasound parameters , HOXA10 protein expression and rates of embryo implantation , clinical pregnancy and live birth were compared .


There were no significant differences between the two groups in endometrial thickness or endometrial volume .


The ultrasonographic endometrial triple-line pattern was present more often in the TEAS group ( p = 0.002 ) .


The TEAS group had a greater endometrial and subendometrial vascularisation index ( VI ) than the mock TEAS group ( p = 0.001 and p < 0.001 , respectively ) on 3D ultrasound and increased endometrial HOXA10 expression ( p = 0.001 ) immediately prior to FET .


Subsequently , the rates of embryo implantation , clinical pregnancy and live birth rates were all higher in the TEAS group than in the mock TEAS group ( p = 0.024 , p = 0.038 and p = 0.033 , respectively ) .


In patients undergoing FET , TEAS may have beneficial effects on endometrial HOXA10 expression and ultrasound markers of endometrial receptivity .


These findings may explain the improvement in clinical outcome of FET associated with the use of TEAS .


ChiCTR-TRC-14004448 .


Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos .


The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing .


Median survival is 8 to 12 months , and most patients have symptoms at diagnosis .


The fittest patients may be offered chemotherapy with palliative intent .


For patients not fit for systemic anticancer treatment , best supportive care remains the mainstay of management .


A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12 weeks after diagnosis .


While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis , oncology and palliative care services in the United Kingdom , and many other countries , vary considerably compared to the United States .


The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma .


This multicentre study is an non-blinded , randomised controlled , parallel group trial .


A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4 weekly regular early specialist symptom control care , or standard care .


The primary outcome is health related quality of life for patients at 12 weeks .


Secondary outcomes include health related quality of life for patients at 24 weeks , carer health related quality of life at 12 and 24 weeks , patient and carer mood at 12 and 24 weeks , overall survival and analysis of healthcare utilisation and cost .


Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness .


This study aims to investigate whether early , regular specialist care input can result in significant health related quality of life gains for patients with mesothelioma and if this change in treatment model is cost-effective .


The results will be widely applicable to many institutions and patients both in the United Kingdom and internationally .


Current controlled trials ISRCTN18955704 .


Date ISRCTN assigned : 31 January 2014 .


To compare toric intraocular lens ( IOL ) implantation and astigmatic keratotomy ( AK ) in correction of astigmatism during phacoemulsification .


Tertiary care hospital .


Prospective randomized trial .


Consecutive patients with visually significant cataract and moderate astigmatism ( 1.25 to 3.00 diopters [ D ] ) were randomized into 2 groups .


Temporal clear corneal 2.75 mm phacoemulsification with toric IOL implantation was performed in the toric IOL group and with 30-degree coupled AK at the 7.0 mm optic zone in the keratotomy group .


The uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuities , refraction , keratometry , topography , central corneal thickness , and endothelial cell density were evaluated preoperatively and 1 day , 1 week , and 1 and 3 months postoperatively .


The study enrolled 34 eyes ( 34 patients ) , 17 in each group .


There was no difference in UDVA or CDVA between the 2 groups at any follow-up visit .


The mean preoperative and postoperative refractive cylinder was 2.00 D 0.49 ( SD ) and 0.33 0.17 D , respectively , in the toric IOL group and 1.95 0.47 D and 0.57 0.41 D , respectively , in the keratotomy group ( P = .10 ) .


The mean residual astigmatism at 3 months was 0.44 1.89 @ 160 in the toric IOL group and 0.77 1.92 @ 174 in the keratotomy group ( P = .61 ) .


All eyes in the toric IOL group and 14 eyes ( 84 % ) in the keratotomy group achieved a residual refractive cylinder of 1.00 D or less ( P = .17 ) .


Toric IOL implantation was comparable to AK in eyes with moderate astigmatism having phacoemulsification .


Impairment in left ventricular systolic function has been described in heart failure ( HF ) with preserved ejection fraction ( HFpEF ) , but its prognostic relevance is not known .


We determined whether left ventricular longitudinal strain ( LS ) is predictive of cardiovascular outcomes in HFpEF beyond clinical and conventional echocardiographic measures .


LS was assessed by 2-dimensional speckle-tracking echocardiography at baseline in 447 patients with HFpEF enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) trial .


At a median follow-up of 2.6 years ( interquartile range , 1.5-3 .9 years ) , 115 patients experienced the primary composite outcome of cardiovascular death , HF hospitalization , or aborted cardiac arrest .


Impaired LS , defined as an absolute LS < 15.8 % , was present in 52 % of patients and was predictive of the composite outcome ( adjusted hazard ratio , 2.14 ; 95 % confidence interval , 1.26-3 .66 ; P = 0.005 ) , cardiovascular death alone ( adjusted hazard ratio , 3.20 ; 95 % confidence interval , 1.44-7 .12 ; P = 0.004 ) , and HF hospitalization alone ( adjusted hazard ratio , 2.23 ; 95 % confidence interval , 1.16-4 .28 ; P = 0.016 ) after adjustment for clinical and conventional echocardiographic variables .


LS was the strongest echocardiographic predictor of the composite outcome .


Exploratory analysis in a subset of 131 patients with follow-up LS assessed after 12 to 18 months demonstrated a trend toward improvement in LS associated with spironolactone in patients enrolled in the Americas but not in Russia or Georgia .


Impaired left ventricular systolic function is a powerful predictor of HF hospitalization , cardiovascular death , or aborted cardiac arrest in HFpEF independent of clinical predictors .


Impaired LS represents a novel imaging biomarker to identify patients with HFpEF at particularly high risk for cardiovascular morbidity and mortality .


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


Unique identifier : NCT00094302 .


We evaluated the effect of different dose hydration protocols , with normal saline or bicarbonate , on the incidence of contrast-induced acute kidney injury ( CI-AKI ) in patients with ST-elevation myocardial infarction ( STEMI ) treated with primary percutaneous coronary intervention ( PPCI ) .


We considered 592 STEMI patients treated with PPCI in 5 Italian centers .


Patients were randomized to receive standard or high-dose infusions of normal saline or sodium bicarbonate started immediately before contrast medium administration and continued for the following 12h .


The cumulative incidence of CI-AKI was 18.1 % without any difference among treatment groups .


Shock , age , ejection fraction 35 % or less , and basal serum creatinine were significantly associated with an increased risk of CI-AKI .


Follow-up at 12 months was complete in 573 patients .


Overall , 25 out of 573 patients died ( 4.3 % ) .


We observed higher short-term mortality rates in patients receiving high-volume hydration .


Otherwise , only age , shock and CI-AKI were significantly associated with 1-year mortality .


In patients with STEMI undergoing PPCI , high-volume hydration with normal saline or sodium bicarbonate administrated at the time of contrast media administration was not associated with any significant advantage in terms of CI-AKI prevention .


The authors examined the effectiveness of virtual reality exposure augmented with D-cycloserine or alprazolam , compared with placebo , in reducing posttraumatic stress disorder ( PTSD ) due to military trauma .


After an introductory session , five sessions of virtual reality exposure were augmented with D-cycloserine ( 50 mg ) or alprazolam ( 0.25 mg ) in a double-blind , placebo-controlled randomized clinical trial for 156 Iraq and Afghanistan war veterans with PTSD .


PTSD symptoms significantly improved from pre - to posttreatment across all conditions and were maintained at 3 , 6 , and 12 months .


There were no overall differences in symptoms between D-cycloserine and placebo at any time .


Alprazolam and placebo differed significantly on the Clinician-Administered PTSD Scale score at posttreatment and PTSD diagnosis at 3 months posttreatment ; the alprazolam group showed a higher rate of PTSD ( 82.8 % ) than the placebo group ( 47.8 % ) .


Between-session extinction learning was a treatment-specific enhancer of outcome for the D-cycloserine group only .


At posttreatment , the D-cycloserine group had the lowest cortisol reactivity and smallest startle response during virtual reality scenes .


A six-session virtual reality treatment was associated with reduction in PTSD diagnoses and symptoms in Iraq and Afghanistan veterans , although there was no control condition for the virtual reality exposure .


There was no advantage of D-cycloserine for PTSD symptoms in primary analyses .


In secondary analyses , alprazolam impaired recovery and D-cycloserine enhanced virtual reality outcome in patients who demonstrated within-session learning .


D-cycloserine augmentation reduced cortisol and startle reactivity more than did alprazolam or placebo , findings that are consistent with those in the animal literature .


To test whether long-term multivitamin supplementation affects the incidence of cataract or age-related macular degeneration ( AMD ) in a large cohort of men .


Randomized , double-blind , placebo-controlled trial .


A total of 14,641 US male physicians aged 50 years .


Daily multivitamin or placebo .


Incident cataract and visually significant AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review .


During an average of 11.2 years of treatment and follow-up , a total of 1817 cases of cataract and 281 cases of visually significant AMD were confirmed .


There were 872 cataracts in the multivitamin group and 945 cataracts in the placebo group ( hazard ratio [ HR ] , 0.91 ; 95 % confidence interval [ CI ] , 0.83-0 .99 ; P = 0.04 ) .


For visually significant AMD , there were 152 cases in the multivitamin group and 129 cases in the placebo group ( HR , 1.19 ; 95 % CI , 0.94-1 .50 ; P = 0.15 ) .


These randomized trial data from a large cohort of middle-aged and older US male physicians indicate that long-term daily multivitamin use modestly and significantly decreased the risk of cataract but had no significant effect on visually significant AMD .


Despite numerous population-based randomized intervention trials , the impact of such interventions on socioeconomic inequalities has rarely been examined .


We used data from a large cluster-randomized trial to assess the impact of a breastfeeding promotion intervention on socioeconomic inequalities in breastfeeding ( exclusivity and duration ) and in child cognitive ability at early school age .


The Promotion of Breastfeeding Intervention Trial ( PROBIT ) randomized 31 Belarusian maternity hospitals and their affiliated polyclinics either to receive a breastfeeding promotion intervention modelled on the WHO/UNICEF Baby-Friendly Hospital Initiative or to continue the standard practices in effect at the time of randomization .


We estimated and compared inequalities in discontinuation of exclusive breastfeeding before 3 months and of any breastfeeding before 12 months and in child verbal IQ at age 6.5 years , across maternal education strata between the two intervention arms .


Socioeconomic inequalities in discontinuing exclusive breastfeeding before 3 months were negligible in the control group .


However , graded inequalities by maternal education emerged in the intervention group { relative risk [ RR ] = 1.12 [ 95 % confidence interval ( CI ) : 1.04 , 1.20 ] for partial university and RR = 1.20 [ 95 % CI : 1.11 , 1.31 ] for secondary education or less vs complete university ; risk difference [ RD ] = 0.06 [ 95 % CI : 0.03 , 0.09 ] and 0.10 [ 95 % CI : 0.06 , 0.14 ] , respectively } .


For discontinuing any breastfeeding before 12 months , small socioeconomic gradients in the control group were widened in the intervention group ( RR = 1.04 and 1.16 , respectively , for mothers with secondary education or less ) .


Despite these differential effects on breastfeeding , however , we observed a small , nonsignificant reduction in socioeconomic inequalities in child verbal IQ at age 6.5 years .


A population-based intervention to promote breastfeeding slightly widened socioeconomic inequalities in breastfeeding but not those in child cognitive ability .


Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone .


ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [ irinotecan plus 5-fluorouracil/folinic acid ( 5-FU/LV ) ] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer .


Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI ( irinotecan 180 mg/m ( 2 ) day 1 , LV 100 mg/m ( 2 ) as 2 h infusion and 5-FU 400 mg/m ( 2 ) as bolus , days 1 and 2 followed by 600 mg/m ( 2 ) / day as 22 h continuous infusion , q14 for four cycles ) followed by docetaxel 75 mg/m ( 2 ) day 1 , cisplatin 75 mg/m ( 2 ) day 1 , q21 for three cycles ( sequential arm ) or De Gramont regimen ( 5-FU/LV arm ) .


From February 2005 to August 2009 , 1106 patients were enrolled , and 1100 included in the analysis : 562 in the sequential arm and 538 in the 5-FU/LV arm .


With a median follow-up of 57.4 months , 581 patients recurred or died ( 297 sequential arm and 284 5-FU/LV arm ) , and 483 died ( 243 and 240 , respectively ) .


No statistically significant difference was detected for both disease-free [ hazard ratio ( HR ) 1.00 ; 95 % confidence interval ( CI ) : 0.85-1 .17 ; P = 0.974 ] and overall survival ( OS ) ( HR 0.98 ; 95 % CI : 0.82-1 .18 ; P = 0.865 ) .


Five-year disease-free and OS rates were 44.6 % and 44.6 % , 51.0 % and 50.6 % in the sequential and 5-FU/LV arm , respectively .


A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy .


ClinicalTrials.gov Identifier : NCT01640782 .


Brain metastases are often accompanied by edema .


Endostatin therapy can prevent tumor tissue edema .


Therefore , we investigated the therapeutic effects of endostatin combined with radiotherapy in the treatment of brain metastases of non-small cell lung cancer ( NSCLC ) and assessed the relations between the effect and vascular endothelial growth factor receptor 2 ( VEGFR2 ) expression .


Eighty patients with brain metastases of NSCLC were randomly divided into a combination therapy group and a radiotherapy-alone group , each group with 40 patients .


The short-term effective rate , overall survival time , cerebral edema index , and adverse reactions were observed , and the expressions of VEGFR2 protein and KDR gene in primary lesions were detected via immunohistochemical methods and fluorescence in-situ hybridization ( FISH ) in all patients .


Compared with the radiotherapy-alone group , brain edema was significantly relieved ( P = .003 ) and there were no marked adverse reactions in the combination therapy group .


Regarding the short-term effective rate , there was no statistical significance in the total population ( n = 80 , 90 % vs. 75 % , P = .07 ) , but there was statistical significance in cases of positive VEGFR2 ( 93 % vs. 67.7 % , P = .012 ) or positive KDR gene ( 94.4 % vs. 47.3 % , P = .002 ) in both groups .


For overall survival time , there was no statistical significance in total population ( n = 80 , P = .35 ) , positive VEGFR2 patients ( P = .109 ) , and positive KDR gene patients ( P = .147 ) .


Compared with radiotherapy alone , endostatin combined with radiotherapy can relieve brain edema in patients with brain metastases of NSCLC and can obtain a better short-term effective rate in patients with positive VEGFR2 or positive KDR gene , but endostatin therapy does not significantly improve overall survival time .


It has been demonstrated that protein ingestion before sleep increases muscle protein synthesis rates during overnight recovery from an exercise bout .


However , it remains to be established whether dietary protein ingestion before sleep can effectively augment the muscle adaptive response to resistance-type exercise training .


Here we assessed the impact of dietary protein supplementation before sleep on muscle mass and strength gains during resistance-type exercise training .


Forty-four young men ( 22 1 y ) were randomly assigned to a progressive , 12-wk resistance exercise training program .


One group consumed a protein supplement containing 27.5 g of protein , 15 g of carbohydrate , and 0.1 g of fat every night before sleep .


The other group received a noncaloric placebo .


Muscle hypertrophy was assessed on a whole-body ( dual-energy X-ray absorptiometry ) , limb ( computed tomography scan ) , and muscle fiber ( muscle biopsy specimen ) level before and after exercise training .


Strength was assessed regularly by 1-repetition maximum strength testing .


Muscle strength increased after resistance exercise training to a significantly greater extent in the protein-supplemented ( PRO ) group than in the placebo-supplemented ( PLA ) group ( +164 11 kg and +130 9 kg , respectively ; P < 0.001 ) .


In addition , quadriceps muscle cross-sectional area increased in both groups over time ( P < 0.001 ) , with a greater increase in the PRO group than in the PLA group ( +8.4 1.1 cm ( 2 ) vs. +4.8 0.8 cm ( 2 ) , respectively ; P < 0.05 ) .