The study included 408 consecutive patients referred for treatment by PRP injection of tendinopathy in the upper ( medial and lateral epicondylar tendons ) and the lower ( patellar , Achilles , hamstring and adductor longus , and peroneal tendons ) limb who received a single intratendinous injection of PRP under US guidance .


Clinical and US data were retrospectively collected for each anatomic compartment for upper and lower limbs before treatment ( baseline ) and 6 weeks after treatment .


Late clinical data without US were collected until 32 months after the procedure ( mean , 20.2 months ) .


The McNemar test and regression model were used to compare clinical and US data .


QuickDASH score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score , and residual US size of lesions were significantly lower after intratendinous injection of PRP under US guidance at 6 weeks and during long-term follow-up compared with baseline ( P < .001 in upper and lower limb ) independent of age , gender , and type of tendinopathy ( P > .29 ) .


No clinical complication was reported during follow-up .


Intratendinous injection of PRP under US guidance appears to allow rapid tendon healing and is well tolerated .


We compare the rate of return to the emergency department ( ED ) within 72 hours between families of children receiving a follow-up telephone call by a non-health care provider asking about the child 's well-being 12 hours after their visit to the ED and families not receiving a follow-up call .


This was a prospective , randomized study in which we conducted a follow-up call starting at 12 hours after discharge from the ED versus no call for follow-up .


At 96 hours after discharge , we contacted all recruited families .


We recorded the rate of return to the ED within 72 hours of discharge .


Of 371 families in the data analysis , 46 % were in the study group , and 55.5 % were male patients .


Mean age was 5.7 years .


The outcome measure was found to be in contrary to our hypothesis .


We found return visits to the ED in 24 ( 14 % ) of the children in the study group compared with only 14 ( 7 % ) in the control group ( P < 0.03 ) .


All other parameters were not statistically different between the groups .


Emergency departments practicing follow-up calls by non-health care providers should consider a forecasted increase in return rates .


Inpatients are visited by many health care providers daily ; many can not remember the name of even one member of their clinical care team .


We provided inpatients with photographs of their clinicians and evaluated the impact on patient recall and communication with their health care providers .


A concealed allocation , randomized controlled trial ( ClinicalTrials.gov NCT01658644 ) was conducted between September 2012 and April 2013 in the general internal medicine wards of a large teaching hospital in Toronto , Canada .


Consenting patients were randomized into 3 groups : the control group received the current standard of care ; the second group received handouts with the names and roles of their clinical care team ; and the third group received handouts with the names , roles , and photographs of their clinical care team .


Before discharge , patients completed a survey on their ability to recall their clinicians and were asked to rate the quality of communication with their care team .


Of the 186 patients ( mean age 61 years , female = 44 % ) who completed surveys ( control n = 60 ; names n = 65 ; photos n = 61 ) , those receiving photos in the handout correctly identified significantly more clinicians by photograph ( P = .001 ) and recalled more names ( P = .002 ) than patients assigned to the control group .


Regarding the perceived quality of communication , the results did not show differences between the control and intervention groups .


In this era of patient-centered care , providing patients with more information about who is directly involved with their health care appears to be warranted .


Primary Sjgren 's Syndrome ( PSS ) mainly affects women ( 9:1 female : male ratio ) and is one of the commonest autoimmune diseases with a prevalence of 0.1 - 0.6 % of adult women .


For patients with PSS there is currently no effective therapy that can alter the progression of the disease .


The aim of the TRACTISS study is to establish whether in patients with PSS , treatment with rituximab improves clinical outcomes .


TRACTISS is a UK multi-centre , double-blind , randomised , controlled , parallel group trial of 110 patients with PSS .


Patients will be randomised on a 1:1 basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy , and will be followed up for up to 48 weeks .


The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness .


Secondary outcomes include ocular dryness , salivary flow rates , lacrimal flow , patient quality of life , measures of disease damage and disease activity , serological and peripheral blood biomarkers , and glandular histology and composition .


The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity .


UKCRN Portfolio ID : 9809 ISRCTN65360827 .


The choice of empirical antibiotic treatment for patients with clinically suspected community-acquired pneumonia ( CAP ) who are admitted to non-intensive care unit ( ICU ) hospital wards is complicated by the limited availability of evidence .


We compared strategies of empirical treatment ( allowing deviations for medical reasons ) with beta-lactam monotherapy , beta-lactam-macrolide combination therapy , or fluoroquinolone monotherapy .


In a cluster-randomized , crossover trial with strategies rotated in 4-month periods , we tested the noninferiority of the beta-lactam strategy to the beta-lactam-macrolide and fluoroquinolone strategies with respect to 90-day mortality , in an intention-to-treat analysis , using a noninferiority margin of 3 percentage points and a two-sided 90 % confidence interval .


A total of 656 patients were included during the beta-lactam strategy periods , 739 during the beta-lactam-macrolide strategy periods , and 888 during the fluoroquinolone strategy periods , with rates of adherence to the strategy of 93.0 % , 88.0 % , and 92.7 % , respectively .


The median age of the patients was 70 years .


The crude 90-day mortality was 9.0 % ( 59 patients ) , 11.1 % ( 82 patients ) , and 8.8 % ( 78 patients ) , respectively , during these strategy periods .


In the intention-to-treat analysis , the risk of death was higher by 1.9 percentage points ( 90 % confidence interval [ CI ] , -0.6 to 4.4 ) with the beta-lactam-macrolide strategy than with the beta-lactam strategy and lower by 0.6 percentage points ( 90 % CI , -2.8 to 1.9 ) with the fluoroquinolone strategy than with the beta-lactam strategy .


These results indicated noninferiority of the beta-lactam strategy .


The median length of hospital stay was 6 days for all strategies , and the median time to starting oral treatment was 3 days ( interquartile range , 0 to 4 ) with the fluoroquinolone strategy and 4 days ( interquartile range , 3 to 5 ) with the other strategies .


Among patients with clinically suspected CAP admitted to non-ICU wards , a strategy of preferred empirical treatment with beta-lactam monotherapy was noninferior to strategies with a beta-lactam-macrolide combination or fluoroquinolone monotherapy with regard to 90-day mortality .


( Funded by the Netherlands Organization for Health Research and Development ; CAP-START ClinicalTrials.gov number , NCT01660204 . )


Spinal cord stimulation is a potential therapeutic option for the treatment of Parkinson 's disease ( PD ) - associated symptoms .


Repetitive trans-spinal magnetic stimulation ( rTSMS ) is a non-invasive and safe alternative for stimulation of spinal pathways that has not been studied for therapeutic efficacy in PD .


We assessed the benefits of rTSMS on camptocormia , an often treatment-resistant postural abnormality observed in PD patients .


We compared rTSMS to sham stimulation in PD patients with camptocormia in a single-centre , randomised , single-blind , crossover , placebo-controlled study .


PD patients with camptocormia were administered a single trial of rTSMS ( a train of 40 stimuli ) or sham treatment followed 1 week later by the alternate treatment .


Primary outcome measure was thoracolumbar spine flexion angle in the standing position immediately after the trial .


Of 320 PD patients examined , 37 had concomitant camptocormia and were randomly assigned to either the rTSMS first group ( n = 19 ) or sham first group ( n = 18 ) .


Flexion angle in the standing position decreased by a mean of 10.9 ( 95 % CI 8.1 to 13.65 ) after rTSMS but remained unchanged after sham stimulation ( mean , -0.1 ; 95 % CI -0.95 to 0.71 ) .


The flexion angle while sitting ( secondary outcome ) decreased by 8.1 ( 95 % CI 5.89 to 10.25 ) after rTSMS , whereas sham treatment had no significant effect ( mean , -0.8 ; 95 % CI -1.62 to 0.05 ) .


We found an immediate beneficial effect of rTSMS on camptocormia in PD patients .


Although the effect was transient , this successful trial justifies further studies to test if repeated rTSMS treatments can induce longer term improvements in camptocormia associated with PD .


UMIN Clinical Trials Registry : UMIN000011495 .


The SP790 study ( ClinicalTrials.gov , NCT00136045 ) showed benefits of rotigotine over placebo in improving symptom severity of restless legs syndrome ( RLS ) , also known as Willis-Ekbom disease , on the International Restless Legs Syndrome Study Group rating scale ( IRLS ) , Clinical Global Impression item 1 ( CGI-1 ) , RLS 6-item questionnaire ( RLS-6 ) , and the RLS-quality of life questionnaire ( RLS-QoL ) in patients with moderate to severe idiopathic RLS .


To provide clinical context for the IRLS and to guide the choice of assessment scales for RLS studies , our post hoc analysis of SP790 data evaluated associations between the IRLS and the CGI-1 , IRLS and RLS-6 , and the IRLS and RLS-QoL .


Scale associations were analyzed at baseline and at the end of maintenance ( EoM ) using data from the safety set ( rotigotine and placebo groups combined [ n = 458 ] ) .


Changes from baseline to EoM in IRLS score vs comparator scale scores also were analyzed .


There was a trend towards increasing IRLS severity category with increasing CGI-1 , RLS-6 , and RLS-QoL score .


Pearson product moment correlation coefficients showed correlations between IRLS and comparator scale scores at baseline and EoM as well as correlations for change from baseline to EoM .


Correlations between the IRLS and comparator scales were substantial .


These data indicate that the IRLS is clinically meaningful .


The IRLS and CGI-1 are generally sufficient to evaluate the overall severity and impact of RLS symptoms in clinical trials .


To evaluate sustained improvements 6 months after a 40-session , in-school computer attention training intervention using neurofeedback or cognitive training ( CT ) administered to 7 - to 11-year-olds with attention-deficit/hyperactivity disorder ( ADHD ) .


One hundred four children were randomly assigned to receive neurofeedback , CT , or a control condition and were evaluated 6 months postintervention .


A 3-point growth model assessed change over time across the conditions on the Conners 3-Parent Assessment Report ( Conners 3-P ) , the Behavior Rating Inventory of Executive Function Parent Form ( BRIEF ) , and a systematic double-blinded classroom observation ( Behavioral Observation of Students in Schools ) .


Analysis of variance assessed community-initiated changes in stimulant medication .


Parent response rates were 90 % at the 6-month follow-up .


Six months postintervention , neurofeedback participants maintained significant gains on Conners 3-P ( Inattention effect size [ ES ] = 0.34 , Executive Functioning ES = 0.25 , Hyperactivity/Impulsivity ES = 0.23 ) and BRIEF subscales including the Global Executive Composite ( ES = 0.31 ) , which remained significantly greater than gains found among children in CT and control conditions .


Children in the CT condition showed delayed improvement over immediate postintervention ratings only on Conners 3-P Executive Functioning ( ES = 0.18 ) and 2 BRIEF subscales .


At the 6-month follow-up , neurofeedback participants maintained the same stimulant medication dosage , whereas participants in both CT and control conditions showed statistically and clinically significant increases ( 9 mg [ P = .002 ] and 13 mg [ P < .001 ] , respectively ) .


Neurofeedback participants made more prompt and greater improvements in ADHD symptoms , which were sustained at the 6-month follow-up , than did CT participants or those in the control group .


This finding suggests that neurofeedback is a promising attention training treatment for children with ADHD .


Over the years , there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture .


It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5years without implant failures , when delayed loading was used .


However , other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied .


Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading .


This prospective nine-center randomized controlled clinical trial is still ongoing .


The final patient will complete the trial in 2016 .


In total , 180 edentulous patients between 60 and 89years with sufficient complete dentures will receive one median implant in the edentulous mandible , which will retain the existing complete denture using a ball attachment .


Loading of the median implant is either immediately after implant placement ( experimental group ) or delayed by 3months of submerged healing at second-stage surgery ( control group ) .


Follow-up of patients will be performed for 24months after implant loading .


The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group .


The secondary outcome measures encompass clinical , technical and subjective variables .


The study was funded by the Deutsche Forschungsgemeinschaft ( German research foundation , KE 477/8 -1 ) .


This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded .


If viable , this treatment option will strongly improve everyday dental practice .


The trial has been registered at Deutsches Register Klinischer Studien ( German register of clinical trials ) under DRKS-ID : DRKS00003730 since 23 August 2012 .


( http://www.germanctr.de ) .


This prospective randomized study aimed to evaluate the role of WBRT+SRS compared to SRS alone and to WBRT alone in improvement of overall survival , brain local control and neurologic manifestations .


The trial included 60 patients with 1 to 3 brain metastases treated at the Radiotherapy Department , National Cancer Institute .


21 patients received WBRT+SRS , 18 patients received SRS alone and 21 patients received WBRT alone .


Median local control was significantly better for WBRT+SRS compared to SRS alone & WBRT alone ( 10 vs 6 vs 5 months , respectively , P = 0.04 ) .


There was non significant survival benefit for WBRT+SRS compared to SRS alone & WBRT alone .


Survival was significantly better for patients with controlled primary tumor who received WBRT+SRS compared to SRS alone & WBRT alone ( median survival was 12 vs 5.5 vs 8 months , respectively .


P = 0.027 ) .


Regardless of the treatment group , median survival and median local control were highly significantly better for single brain site involvement compared to multiple brain sites involvement ( P = 0.003 & P = 0.001 , respectively ) , and median brain local control was significantly better for single lesion compared to multiple lesions ( P = 0.05 ) .


WBRT+SRS is an effective , safe tool in treatment of patients with 1 to 3 brain metastses improving the brain local control , but further studies with larger number of patients is recommended .


Depressive symptoms and reduced quality of life ( QOL ) are parts of the chronic stress syndrome and predictive of adverse outcome in patients with ischemic heart disease ( IHD ) .


Chronic stress is associated with increased sensitivity for pain , which can be measured by algometry as Pressure Pain Sensitivity ( PPS ) on the sternum .


To evaluate if stress focus by self-measurement of PPS , followed by stress reducing actions including acupressure , can decrease depressive symptoms and increase psychological well-being in people with stable IHD .


Observer blinded randomized clinical trial over 3 months of either intervention or treatment as usual ( TAU ) .


Intention to treat .


Two hundred and thirteen participants with IHD were included : 106 to active treatment and 107 to TAU .


Drop-out : 20 and 12 , respectively .


The active intervention included self-measurement of PPS twice daily followed by acupressure as mandatory action , aiming at a reduction in PPS .


Primary endpoint : change in depressive symptoms as measured by Major depression inventory ( MDI ) .


Other endpoints : changes in PPS , Well-being ( WHO-5 ) and mental and physical QOL ( SF-36 ) .


At 3 months PPS decreased 28 % , to 58 , in active and 11 % , to 72 , in TAU , p < 0.001 .


MDI decreased 22 % , to 6.5 , in active group vs. 12 % , to 8.3 in TAU , p = 0.040 .


WHO-5 increased to 71.0 and 64.8 , active group and TAU , p = 0.015 .


SF-36 mental score sum increased to 55.3 and 53.3 , active and TAU , p = 0.08 .


PPS measurements followed by acupressure reduce PPS , depressive symptoms and increase QOL in patients with stable IHD .


ClinicalTrials.gov NCT01513824 .


To investigate the postoperative analgesic effects of preemptive dexketoprofen trometamol in dogs subjected to ovariohysterectomy ( OHE ) .


Seventeen adult bitches of various breeds were used in this study .


The dogs were randomly allocated into of two groups .


Subjects in the dexketoprofen trometamol ( DEX ) group ( n = 10 ) , received intravenous ( i.v. ) dexketoprofen trometamol , 1 mg/kg , 15 minutes before premedication , while those assigned to the control ( C ) group ( n = 7 ) were given no analgesics prior to premedication .


Pain level was assessed by two researchers before the administration of anaesthesia ( 15 minutes before start ) and 0 , 1 , 2 , 4 and 6 hours after surgery .


A modified University of Melbourne Pain Scale ( UMPS ) was used to evaluate pain in both groups .


Serum cortisol level changed from 0 to 1 h and from 0 to 1 to 4 h were compared between the groups ; the increase in the C group was statistically significant .


The modified UMPS was applied to both groups at baseline and postoperative 1 , 2 , 4 and 6 h.


According to this test , the values for DEX were significantly lower than controls at 4 and 6 h ( p < 0.001 ) .


Stable vital signs with unchanged biochemical parameters on dexketoprofen administration are a promising finding .


The clinical advantage shown by the pain scale difference and the low serum cortisol levels should qualify dexketoprofen for preemptive pain management in dogs ( Tab .


5 , Fig. 2 , Ref .


30 ) .


This prospective study aims to explore the benefit of cytokine-induced killer cell ( CIK ) treatment in hepatocellular carcinoma patients , which has not yet been thoroughly studied before .


From January 2004 to May 2009 , 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer ( BCLC ) stage A , B or C , Child-Pugh scores of A or B and without prior treatment were enrolled in the study .


Patients were randomly assigned to either arm 1 ( n = 66 ) to receive CIK treatment plus standard treatment , or arm 2 ( n = 66 ) to receive standard treatment only .


The primary end point was overall survival ( OS ) and the secondary endpoint was progression-free survival as evaluated by Kaplan-Meier analyses and treatment hazard ratios with the Cox proportional hazards model .


The 1-year ( OS : 74.2 % vs. 50.0 % , 95 % CI : 63.6-84 .8 % vs. 37.8-62 .2 , p = 0.002 ) , 2-year ( OS : 53.0 % vs. 30.3 % , 95 % CI : 40.8-65 .2 % vs. 19.1-41 .5 % , p = 0.002 ) , 3-year ( OS : 42.4 % vs. 24.2 % , 95 % CI : 30.4-54 .4 % vs. 13.8-34 .6 % , p = 0.005 ) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2 .


Therefore , in patients who are not suitable for surgery , significant benefit is obtained from CIK treatment .


The main adverse effects of CIK included fever , allergy and headache pain .


Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment .


The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery .


Brain swelling may result in increased intracranial pressure , impeded tumor exposure , and adverse outcomes .


Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery .


Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery ; however , these results need further confirmation , and the optimal mannitol dose has not yet been established .


We propose to examine whether different doses of 20 % mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision .


We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery .


This is a single-center , randomized controlled , parallel group trial that will be carried out at Beijing Tiantan Hospital , Capital Medical University .


Randomization will be achieved using a computer-generated table .


The study will include 220 patients undergoing supratentorial tumor surgery whose preoperative computed tomography/magnetic resonance imaging results indicate a brain midline shift .


Patients in group A , group B , and group C will receive dehydration treatment at incision with 20 % mannitol solutions of 0.7 , 1.0 , and 1.4 g/kg , respectively , at a rate of 600 mL/h .


The patients in the control group will not receive mannitol .


The primary outcome is an improvement in intraoperative brain relaxation and dura tension after dehydration with mannitol .


Secondary outcomes are postoperative outcomes and the incidence of mannitol side effects .


The aim of this study is to determine the optimal dose of 20 % mannitol for intraoperative infusion .


We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery .


If our results are positive , the study will indicate the optimal dose of mannitol to improve brain relaxation and avoid side effects during brain tumor surgery .


The study is registered with the registry website http://www.chictr.org with the registration number ChiCTRTRC13003984 ( 17 December 2013 ) .


Laquinimod is an oral therapeutic agent under investigation for the treatment of Crohn 's disease ( CD ) , Huntington 's disease , lupus nephritis and multiple sclerosis .


This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate-severe CD .


Multicentre , double-blind , sequential-cohort , randomised controlled trial with laquinimod doses of 0.5 , 1 , 1.5 or 2mg/day or placebo ( n = 45 per cohort randomised in a 2:1 ratio ) for 8weeks with 4-week follow-up .


Stable concomittant therapies and prior use of anti-tumour necrosis factor agents were permitted .


Comprehensive safety assessments were performed and efficacy analyses included the proportions of patients in clinical remission ( CD Activity Index ( CDAI ) < 150 and no treatment failure ( TF ) ) , and with a clinical response ( 70 or 100 point CDAI reduction from baseline or remission and no TF ) .


117 patients received laquinimod and 63 patients received placebo .


The overall incidence of adverse events ( AEs ) in the laquinimod group was similar to the pooled placebo group ( 86.2 % -96.7 % vs 82.5 % ) and most AEs were mild to moderate in severity .


Treatment with laquinimod 0.5 mg showed consistent effects on remission ( 48.3 % ( CI 31 % to 66 % ) vs 15.9 % ( CI 9 % to 27 % ) ) , response 100 ( 55.2 % ( CI 37 % to 71 % ) vs 31.7 % ( CI 22 % to 44 % ) ) and response 70 ( 62.1 % ( CI 44 % to 77 % ) vs 34.9 % ( CI 24 % to 47 % ) ) versus placebo .


Laquinimod 1.0 mg showed less benefit ( 26.7 % remission ( CI 14 % to 44 % ) and 53.3 % response 70 ( CI 36 % to 70 % ) ) , and no effect was noted on remission/response at higher doses .


Laquinimod was safe and well tolerated , and the effects on remission and response of the 0.5 mg dose suggest a treatment benefit in patients with CD .


NCT00737932 .


Deep general anesthesia has been associated with increased mortality in 5 observational studies .


The association may be causal or an epiphenomenon due to increased anesthetic sensitivity in high-risk patients .


We conducted a pilot study to assess the feasibility of performing a definitive randomized controlled trial .


The aims of the study were to determine whether anesthetic depth targeting in a high-risk group was feasible and to document anesthetic doses and arterial blood pressures associated with `` deep '' and `` light '' general anesthesia .


ASA physical status III and IV patients , aged 60 years , having surgery lasting 2 hours , with expected hospital stay 2 days , and receiving general anesthesia were randomly allocated to a Bispectral Index ( BIS ) or spectral entropy ( SE ) target of 35 ( `` low '' group ) or 50 ( `` high '' group ) .


The primary end point was mean BIS or SE .


Secondary end points were postanesthesia care unit length of stay and pain scores , quality of recovery score , hospital length of stay , postoperative complications , and death .


A composite end point of postoperative complications ( pneumonia , myocardial infarction , stroke , pulmonary embolism , heart failure , and death ) was determined at 1 year .


One hundred twenty-five patients were recruited .


The mean of the median BIS/SE values for each patient during the maintenance phase of anesthesia in the low and high groups was significantly different : 39 vs 48 ( mean difference 8 [ 95 % confidence interval { CI95 } , 6 to 10 ] , P < 0.001 ) .


There was also a significant difference in mean volatile anesthetic administration ( minimum alveolar concentration ) : 0.98 vs 0.64 ( mean difference -0.35 [ CI95 , -0.44 to -0.26 ] , P < 0.001 ) and target propofol concentrations : 4.0 vs 3.1 g/mL ( mean difference -0.8 [ CI95 , -1.2 to -0.3 ] , P = 0.004 ) .


Intraoperative mean arterial blood pressures were similar ( 85 vs 87 mm Hg ; mean difference 2 [ CI95 , -2 to 6 ] , P = 0.86 ) , and there were no differences in short-term recovery characteristics or hospital length of stay .


There was a significant difference in the incidence of wound infection at 30 days ( 13 % vs 3 % ; risk difference -10 % [ CI95 , -21 to -0.1 ] , P = 0.04 ) .


At 1 year , the composite rates of complications in the low and high groups were 28 % and 17 % ( risk difference -11 [ CI95 , -25 to 4 ] , P = 0.15 ) and mortality rates were 12 % and 9 % , respectively ( risk difference -2 [ CI95 , -14 to 9 ] , P = 0.70 ) .


This pilot study demonstrated that depth of anesthesia targeting with BIS or SE was achievable in a high-risk population with adequate separation of processed electroencephalogram monitor targets .


The expected incidence of postoperative complications and mortality occurred .


We conclude that a large , multicenter , randomized controlled trial is feasible .


Daily oral triple therapy is effective at halting HIV disease progression , but can have toxic effects and is costly .


We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy .


The GARDEL study ( Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy ) is a 48 week , phase 3 , randomised , controlled , open-label , non-inferiority trial in antiretroviral-therapy-naive adults ( age 18 years ) with documented HIV-1 RNA viral load of at least 1000 copies per mL .


The study was done at 19 centres in six countries .


Patients were randomly assigned ( 1:1 ) to dual therapy or triple therapy by sealed envelopes , in blocks of four , stratified by baseline viral load ( < 100,000 vs 100,000 copies per mL ) .


Dual therapy consisted of lopinavir 400 mg and ritonavir 100 mg plus lamivudine 150 mg , both twice daily .


Triple therapy consisted of lopinavir 400 mg and ritonavir 100 mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor ( NRTI ) in fixed-dose combination .


Efficacy was analysed in all participants who received at least one dose of study drug .


The primary endpoint was virological response rate , defined as the proportion of patients with HIV RNA less than 50 copies per mL at 48 weeks .


Dual therapy was classed as non-inferior to triple therapy if the lower bound of the 95 % CI for the difference between groups was no lower than -12 % .


Patients and investigators were unmasked to treatment allocation .


This study is registered with ClinicalTrials.gov , number NCT01237444 .


Between Dec 10 , 2010 , and May 15 , 2012 , 217 patients were randomly assigned to the dual-therapy group and 209 to the triple-therapy group .


198 patients in the dual-therapy group and 175 in the triple-therapy group completed 48 weeks of treatment .


At week 48 , 189 patients ( 883 % ) in the dual-therapy group and 169 ( 837 % ) in the triple-therapy group had viral response ( difference 46 % , 95 % CI -22 to 118 ; p = 0171 ) .


Patients with baseline viral load of at least 100,000 copies per mL showed similar results ( 872 % vs 779 % , respectively ; difference 93 % , 95 % CI -28 to 215 ; p = 0145 ) .


Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group ( n = 10 [ 49 % ] ) than in the dual-therapy group ( n = 1 [ 04 % ] ; difference 45 % , 95 % CI -81 to -09 ; p = 0011 ) .


65 adverse events in the dual-therapy group and 88 in the triple-therapy group were possibly or probably drug related ( p = 0007 ) .


Two serious adverse events occurred , both in the dual-therapy arm , one of which ( a case of gastritis ) was reported as possibly or probably related to drug treatment .


Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients .


Fundacin Husped and AbbVie .


This phase III randomized trial ( ClinicalTrials.gov identifier : NCT00337103 ) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer ( MBC ) .


Women with MBC who had received prior anthracycline - and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first - , second - , or third-line chemotherapy for advanced/metastatic disease .


Stratification factors were human epidermal growth factor receptor-2 ( HER2 ) status and geographic region .


Coprimary end points were overall survival ( OS ) and progression-free survival ( PFS ) .


Median OS times for eribulin ( n = 554 ) and capecitabine ( n = 548 ) were 15.9 and 14.5 months , respectively ( hazard ratio [ HR ] , 0.88 ; 95 % CI , 0.77 to 1.00 ; P = .056 ) .


Median PFS times for eribulin and capecitabine were 4.1 and 4.2 months , respectively ( HR , 1.08 ; 95 % CI , 0.93 to 1.25 ; P = .30 ) .


Objective response rates were 11.0 % for eribulin and 11.5 % for capecitabine .


Global health status and overall quality-of-life scores over time were similar in the treatment arms .


Both treatments had manageable safety profiles consistent with their known adverse effects ; most adverse events were grade 1 or 2 .


In this phase III study , eribulin was not shown to be superior to capecitabine with regard to OS or PFS .


To examine the association between familial high lipoprotein ( a ) , or Lp ( a ) , concentrations and endothelial function in children participating in the Special Turku Coronary Risk Factor Intervention Project study .


Seven-month-old children ( n = 1062 ) with their families were randomized to a risk intervention group or to a control group .


The intervention group received individualized dietary counseling to reduce the total cholesterol concentration .


Children 's Lp ( a ) and lipid values were measured repeatedly .


At age 11 years , children were recruited to an ultrasound study of the flow-mediated dilation ( FMD ) of the brachial artery .


The association between relative peak FMD and Lp ( a ) concentration was examined in 198 control and 193 intervention group children by linear regression analyses adjusted for sex , total cholesterol concentration , and basal artery diameter .


The analyses were made in both the control and intervention groups and in the familial risk children who had a parent with Lp ( a ) concentration greater than 250 mg/l .


Lp ( a ) concentrations were similar at age 11 years in the intervention and control groups .


In all control children , FMD ( % ) associated inversely with Lp ( a ) concentration : ( [ % / 1000 mg/L ] = -3.74 , 95 % CI [ -6.43 , -1.45 ] ; P = .007 ) and in 68 familial risk children ( = -4.92 , 95 % CI [ -8.18 , -1.66 ] ; P = .0037 ) .


In the intervention group the associations were lacking ( P > .5 ) , and FMD in the children with high Lp ( a ) concentrations ( > 500 mg/L , n = 12 ) had no attenuation ( P = .027 ) .


Familial high Lp ( a ) concentration is associated with attenuated endothelial function .


This association may be mitigated by an early lifestyle intervention .


ClinicalTrials.gov : NCT00223600 .


Differences in patient tolerance , acceptance , and satisfaction of esophagogastroduodenoscopy ( EGD ) between transnasal ( TN ) and peroral ( PO ) routes using a 5-mm video endoscope .


A total of 220 enrolled patients were assigned randomly to two groups undergoing EGD-110 patients each for TN and PO .


The successful rate , procedure time , and adverse events were recorded .


After the procedure , patients answered a validated questionnaire of tolerance , acceptance , and satisfaction .


There were 6 failures ( 5.7 % ) of nasal intubation and two nasal bleeding ( 2 % ) among 105 TN-EGD procedures .


All PO patients ( n = 102 ) completed EGD successfully without adverse event .


Compared to PO , the procedure of TN achieved lower successful rate ( 94 % vs. 100 % , p = 0.01 ) , was complicated with epistaxis ( 2 % vs. 0 % ) and took longer ( mean SD 19.9 6.1 min vs. 16.8 6.4 min , p = 0.0001 ) .


The patients undergoing TN-EGD indicated less discomfort during passing pharynx ( scores of 2.1 2.0 vs. 3.1 2.6 , p = 0.011 ) but more pain during inserting scope ( scores of 2.2 1.6 vs. 1.5 1.8 , p = 0.0001 ) .


Eventually , there were no significant differences between TN and PO regarding the overall procedure discomfort ( scores of 10.7 6.6 vs. 11.1 7.8 scores , p = 0.9 ) , satisfaction ( scores of 41.2 4.2 vs. 41.3 4.6 , p = 0.91 ) , and acceptability ( 87.8 % vs. 94.2 % , p = 0.91 ) .


PO intubation seems an excellent alternative method when using a 5-mm ultrathin endoscopy because it achieves comparable patient tolerance , acceptance , and satisfaction as TN intubation , takes less time and causes lower intubation failure and epistaxis .


The purpose was to evaluate the acceptability and feasibility of hand massage therapy in the intensive care unit ( ICU ) .


Clinical guidelines suggest the use of non-pharmacological interventions for pain management in ICU adults .


The results presented are secondary to a pilot RCT evaluating the preliminary effectiveness of hand massage on pain after cardiac surgery .


A qualitative descriptive design was used .


Acceptability was evaluated using individual interviews with participants in both groups i.e. , experimental and control ( n = 40 ) .


Feasibility was examined using field notes and video recordings .


While participants receiving the massage perceived it as appropriate , the control group suggested different dosages of the treatment and body areas targeted .


Results also suggest that barriers ( e.g. noise , numerous clinical activities ) need to be overcome .


Increasing staff acceptance , reducing the rest period , involving families , and repeating the treatment are avenues to consider .


Building evidence for non-pharmacological pain management in the critical care setting is necessary .


The purpose of this study was to investigate whether a shorter language sample elicited with fewer pictures ( i.e. , 7 ) would yield a percent grammatical utterances ( PGU ) score similar to that computed from a longer language sample elicited with 15 pictures for 3-year-old children .


Language samples were elicited by asking forty 3-year-old children with varying language skills to talk about pictures in response to prompts .


PGU scores were computed for each of two 7-picture sets and for the full set of 15 pictures .


PGU scores for the two 7-picture sets did not differ significantly from , and were highly correlated with , PGU scores for the full set and with each other .


Agreement for making pass-fail decisions between each 7-picture set and the full set and between the two 7-picture sets ranged from 80 % to 100 % .


The current study suggests that the PGU measure is robust enough that it can be computed on the basis of 7 , at least in 3-year-old children whose language samples were elicited using similar procedures .


This was a prospective randomized single-blinded clinical trial comparing the glottic views obtained during direct laryngoscopy between the ` sniffing the morning air ' position and simple head extension .


A sample of 378 patients , aged 18 to 75 years old with ASA physical status I or II , scheduled for elective surgery under general anesthesia with endotracheal intubation , were randomized into 2 groups .


Group A used the sniffing position during the first laryngoscopy while Group B was put in simple head extension position .


Positions were then interchanged for the second laryngoscopy .


Sniffing position was obtained by placing a 7 cm height non-compressible cushion under the patient 's head .


In simple head extension , patient 's head was placed flat .


Glottic visualization was assessed based on the Cormack & Lehane scale .


Intubation was performed after second laryngoscopy and success rate of first attempt intubation was compared .


The distribution of patients with different Cormack & Lehane scores between the two intubation positions were significantly different ( p < 0.001 ) .


Changing over to the ` Sniffing position ' resulted in improvement of the Cormack & Lehane scores in 109 ( 57.7 % ) patients , no change in 75 ( 39.7 % ) or worsening in 5 ( 4.8 % ) patients .


Successful intubation at first attempt was better ( p < 0.05 ) with Group A : 156 ( 83.5 % ) while Group B : 121 ( 64.0 % ) .


Sniffing position provided better glottic visualization score and increased the successful rate of intubation as compared to simple head extension .


Many risks of death in childhood bacterial meningitis are well-identified , but factors influencing survival time have received less attention .


Better understanding of this issue could help explain why adjuvant medications have performed unevenly in different trials .


In a post hoc analysis of prospectively collected data from a large bacterial meningitis treatment trial in Luanda , Angola , we compared time to death after initiation of antimicrobial treatment among 206 children with etiology and other patient characteristics .


The risks of dying very quickly ( 0-4 hours ) , quickly ( 4-8 hours ) or after longer periods were analyzed by logistic regression .


Median time to death was 18.5 hours , half the time in Streptococcus pneumoniae ( 11.8 hours ) compared with Haemophilus influenzae ( 26.8 hours ) meningitis .


Of all deaths caused by pneumococcal or H.influenzae meningitis , 42 % versus 16 % , respectively , occurred within the first 8 hours .


In addition , patients who succumbed within 8 hours , unlike those dying later , had a short disease history , shock , hypoglycemia and poor cerebrospinal fluid white cell response .


Time to death in Angola is so short that hardly anything , except perhaps modern intensive care , is likely to improve outcome in a patient with meningitis , especially the pneumococcal disease .


Quadrivalent human papillomavirus ( HPV ) vaccine , for protection against sexually transmitted HPV infection , is licensed for females and males 9-26 years on a 3-dose schedule ( 0 , 2 , and 6 months ; Standard schedule ) .


Vaccine uptake has been low and catch-up vaccination of older adolescents using an alternate dosing schedule may increase coverage .


This study tested the non-inferiority of the immunogenicity of an alternate dosing schedule ( 0 , 2 , 12 months ) among college age males .


220 18-25 year old males were randomly assigned to Standard or Alternate schedules .


Blood samples were drawn immediately before Dose 1 and 2-6 weeks after Dose 3 and analyzed for antibody titers using a Luminex immunoassay .


A value < 1.5 for the upper 95 % confidence interval ( CI ) bound of the Standard to Alternate schedule geometric mean titer ( GMT ) ratio was deemed non-inferior .


Participants averaged 21.3 years old ; 19.1 % were non-white ; completion rate was 93 % .


The anti-HPV titers for the Alternate schedule group were non-inferior to those of Standard schedule group for all four HPV vaccine virus types .


Our results also demonstrated superiority of the Alternate schedule group for all four HPV vaccine virus types .


A delayed third dose at 12 months is immunologically non-inferior and superior for four HPV virus types .


Using an alternate dosing schedule offers more flexibility to receive the 3-dose HPV vaccine and may result in higher vaccination rates among college-age males .


Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention ( BI ) for hospitalized individuals who screen positive for unhealthy alcohol use , the spectrum of use ranging from hazardous use to alcohol use disorders .


These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals .


The few BI trials conducted with hospital inpatients vary widely in methodological quality .


While the majority of these studies indicate limited to no effects of BI in this population , none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null : assessment reactivity ( AR ) .


This is a three-arm , single-site , randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder .


Participants are randomized to one of three study conditions .


Study Arm 1 receives a three-part alcohol BI .


Study Arm 2 receives attention control .


To account for potential AR , Study Arm 3 receives AC with limited assessment .


Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge .


Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use .


To assess differences in primary outcomes across the three arms , we will use mixed-effects regression models that account for a patient 's repeated measures over the timepoints and clustering within medical units .


Intervention implementation will be assessed by : a ) review of intervention audio recordings to characterize barriers to intervention fidelity ; and b ) feasibility of participant recruitment , enrollment , and follow-up .


The results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures .


NCT01602172 .


Although brief intervention is effective for reducing problem alcohol use , few data exist on its effectiveness for reducing problem drug use , a common issue in disadvantaged populations seeking care in safety-net medical settings ( hospitals and community health clinics serving low-income patients with limited or no insurance ) .


To determine whether brief intervention improves drug use outcomes compared with enhanced care as usual .


A randomized clinical trial with blinded assessments at baseline and at 3 , 6 , 9 , and 12 months conducted in 7 safety-net primary care clinics in Washington State .


Of 1621 eligible patients reporting any problem drug use in the past 90 days , 868 consented and were randomized between April 2009 and September 2012 .


Follow-up participation was more than 87 % at all points .


Participants received a single brief intervention using motivational interviewing , a handout and list of substance abuse resources , and an attempted 10-minute telephone booster within 2 weeks ( n = 435 ) or enhanced care as usual , which included a handout and list of substance abuse resources ( n = 433 ) .


The primary outcomes were self-reported days of problem drug use in the past 30 days and Addiction Severity Index-Lite ( ASI ) Drug Use composite score .


Secondary outcomes were admission to substance abuse treatment ; ASI composite scores for medical , psychiatric , social , and legal domains ; emergency department and inpatient hospital admissions , arrests , mortality , and human immunodeficiency virus risk behavior .


Mean days used of the most common problem drug at baseline were 14.40 ( SD , 11.29 ) ( brief intervention ) and 13.25 ( SD , 10.69 ) ( enhanced care as usual ) ; at 3 months postintervention , means were 11.87 ( SD , 12.13 ) ( brief intervention ) and 9.84 ( SD , 10.64 ) ( enhanced care as usual ) and not significantly different ( difference in differences , = 0.89 [ 95 % CI , -0.49 to 2.26 ] ) .


Mean ASI Drug Use composite score at baseline was 0.11 ( SD , 0.10 ) ( brief intervention ) and 0.11 ( SD , 0.10 ) ( enhanced care as usual ) and at 3 months was 0.10 ( SD , 0.09 ) ( brief intervention ) and 0.09 ( SD , 0.09 ) ( enhanced care as usual ) and not significantly different ( difference in differences , = 0.008 [ 95 % CI , -0.006 to 0.021 ] ) .


During the 12 months following intervention , no significant treatment differences were found for either variable .


No significant differences were found for secondary outcomes .


A one-time brief intervention with attempted telephone booster had no effect on drug use in patients seen in safety-net primary care settings .


This finding suggests a need for caution in promoting widespread adoption of this intervention for drug use in primary care .


clinicaltrials.gov Identifier : NCT00877331 .


An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer .


50 subjects , 21 males and 29 females aged between 21 and 65 , were randomized to receive 150 restorations , 100 with the new restorative material , 50 with the composite as control , placed in non-carious cervical lesions with the same bonding system .


The main outcome measure was the cause of failure at 8 years .


Randomization was number table-generated , with allocation concealment by opaque sequentially numbered sealed and stapled envelopes .


Subjects , examiner , and analyst were blinded to group assignment .


Two interim analyses were performed .


Data were analyzed by ANOVA and Cox test ( P < 0.05 ) .


After 8 years , 40 subjects and 120 teeth were included in the analysis of the primary outcome .


There were eight failures in the experimental group and four failures in the control group .


The cumulative loss rate was 7 % for both restorative materials , with the annual failure lower than 1 % , without any statistically significant difference .


There were two key elements of failure : the presence of sclerotic dentin and the relationship between lesion and gingival margin .


The therapeutic and economic benefits of continuous positive airway pressure ( CPAP ) for moderate to severe obstructive sleep apnoea ( OSA ) syndrome have been established in middle-aged people ; however , the benefits in older people are unknown .


This trial was designed to address this evidence gap .


This 12-month , multicentre , randomised trial enrolled patients across 14 National Health Service sleep centres in the UK .


Consecutive patients aged 65 years or older with newly diagnosed OSA syndrome were eligible to join the trial .


Patients were randomly assigned ( 1:1 ) into parallel groups to receive either CPAP with best supportive care ( BSC ) or BSC alone for 12 months .


Randomisation was done by the Medical Research Council Clinical Trials Unit with computer-generated randomisation .


The main investigator at each centre was masked to the trial randomisation .


Coprimary endpoints were Epworth sleepiness score ( ESS ) at 3 months and cost-effectiveness over the 12-month trial period .


Secondary outcomes were subjective sleepiness at 12 months , plus objective sleepiness , quality of life , mood , functionality , nocturia , mobility , accidents , cognitive function , and cardiovascular risk factors and events at 3 months and 12 months .


The analysis was by intention to treat .


This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN90464927 .


Between Feb 24 , 2010 , and May 30 , 2012 , 278 patients were randomly assigned to the trial , of whom 231 ( 83 % ) completed the trial .


140 patients were allocated to and received CPAP plus BSC and 138 were allocated to and received BSC only .


CPAP reduced ESS by 21 points ( 95 % CI -30 to -13 ; p < 00001 ) at 3 months for 124 ( 89 % ) of 140 patients compared with 124 ( 90 % ) of 138 patients given BSC , and by 20 points ( -28 to -12 ; p < 00001 ) at 12 months for 116 patients compared with 122 patients given BSC .


The effect was greater in patients with higher CPAP usage or higher baseline ESS .


Quality-adjusted life-years were similar between the groups ( treatment effect 001 ( 95 % CI -003 to 004 ; p = 0787 ) and health-care costs were marginally reduced with CPAP ( -35 , -390 to 321 ; p = 0847 ) .


CPAP improved objective sleepiness ( p = 0024 ) , mobility ( p = 0029 ) , total cholesterol ( p = 0048 ) , and LDL cholesterol ( p = 0042 ) at 3 months , but these were not sustained at 12 months .


Measures of mood , functionality , nocturia , accidents , cognitive function , and cardiovascular events remained unchanged .


Systolic blood pressure fell in the BSC group .


37 serious adverse events occurred in the CPAP group , and 22 in BSC group ; all were independently classified as being unrelated to the trial and no significant harm was attributed to CPAP use .


In older people with OSA syndrome , CPAP reduces sleepiness and is marginally more cost effective over 12 months than is BSC alone .


On the basis of these results , we recommend that CPAP treatment should be offered routinely to older patients with OSA syndrome .


National Institute of Health Research ( NIHR ) Health Technology Assessment , NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London .


During lower limb lengthening , poor bone regeneration is a devastating complication .


Several local or systemic applications have been used to promote osteogenesis , and biologic stimulations are gaining attention , but their utility has not been proven in this setting .


In patients undergoing bilateral tibial lengthening , we compared those receiving an osteotomy site injection of autologous bone marrow aspirate concentrate ( BMAC ) plus platelet-rich plasma ( PRP ) with those not receiving such an injection in terms of external fixator index ( time in external fixation divided by amount of lengthening ) , full weightbearing index ( time until a patient was permitted to do full weightbearing divided by amount of lengthening ) , four cortical healing indexes ( time until each cortical union divided by amount of lengthening ) , and callus shape and type .


Twenty-two patients ( 44 tibias ) undergoing bilateral tibial lengthening enrolled in this randomized trial .


Two patients were excluded , one due to insufficient radiographic evaluation and one who was lost to followup , leaving 20 patients ( 40 segments ) for inclusion .


Ten patients ( 20 segments ) received BMAC combined with PRP injection ( treatment group ) and 10 patients ( 20 segments ) received no injection ( control group ) .


All patients underwent stature lengthening for familial short stature with the lengthening over nail technique .


Autologous BMAC combined with PRP was injected at the tibial osteotomy site at the end of the index surgery .


Mean distraction rates were similar between groups ( 0.75 mm/day in the treatment group versus 0.72 mm/day in the control group ; p = 0.24 ) .


Full weightbearing was permitted when we observed radiographic evidence of healing at two cortices ; this assessment was made by the surgeon who was blinded to the treatment each patient received .


Minimum followup was 24 months ( mean , 28 months ; range , 24-34 months ) .


There was no difference in mean external fixator index between groups .


However , mean cortical healing indexes ( anterior/posterior/medial / lateral ) were 1.14 / 0.81 / 0.96 / 0.88 months/cm in the treatment group and 1.47 / 1.26 / 1.42 / 1.22 months/cm in the control group ( all p < 0.001 ) , showing faster healing in the treatment group at each cortex .


Full weightbearing was permitted earlier in the treatment group than in the control group ( index : 0.99 months/cm and 1.38 months/cm , respectively , p < 0.001 ) .


Callus shape and type were not different between groups .


Autologous BMAC combined with PRP injection at the osteotomy site helped improve bone healing in distraction osteogenesis of the tibia , although the effect size was small .


Level I , therapeutic study .


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


We determined the effectiveness of primary care-based , and pre - and postnatal interventions to increase breastfeeding .


We conducted 2 trials at obstetrics and gynecology practices in the Bronx , New York , from 2008 to 2011 .


The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study ( PAIRINGS ) had 2 arms : usual care versus pre - and postnatal visits with a lactation consultant ( LC ) and electronically prompted guidance from prenatal care providers ( EP ) .


The Best Infant Nutrition for Good Outcomes ( BINGO ) study had 4 arms : usual care , LC alone , EP alone , or LC+EP .


In BINGO at 3 months , high intensity was greater for the LC+EP ( odds ratio [ OR ] = 2.72 ; 95 % confidence interval [ CI ] = 1.08 , 6.84 ) and LC ( OR = 3.22 ; 95 % CI = 1.14 , 9.09 ) groups versus usual care , but not for the EP group alone .


In PAIRINGS at 3 months , intervention rates exceeded usual care ( OR = 2.86 ; 95 % CI = 1.21 , 6.76 ) ; the number needed to treat to prevent 1 dyad from nonexclusive breastfeeding at 3 months was 10.3 ( 95 % CI = 5.6 , 50.7 ) .


LCs integrated into routine care alone and combined with EP guidance from prenatal care providers increased breastfeeding intensity at 3 months postpartum .


Recurrent aphthous stomatitis ( RAS ) is the most common oral mucosal disease .


However , the available therapies for RAS only relieve symptoms and do not provide a cure .


This study assessed the response to treatment with levamisole and low-dose prednisolone drug combination in patients with RAS .


Fifty RAS subjects were enrolled in the single-blind randomized placebo-controlled trial .


Study medications were administered thrice daily for 3 consecutive days/week for 3 consecutive weeks .


Patients in Group 1 received placebo , Group 2 received levamisole ( 50 mg ) and Group 3 received levamisole ( 50 mg ) and low-dose prednisolone ( 5 mg ) .


Patients were followed up for 60 days after treatment .


Response to treatment was assessed using the following clinical parameters : pain due to ulcers , number of ulcers/episode , size of ulcers , duration of ulcers , and frequency of ulcers ( episodes/month ) .


MannWhitney U-test .


A statistically significant improvement was noted in all parameters except for the size of ulcers in patients treated with levamisole alone and with combination of levamisole and low-dose prednisolone .


There was no statistically significant improvement in the placebo group .


Both active groups had significantly better improvement when compared to placebo group , while there was no significant difference between the two active groups .


Levamisole alone and combination of levamisole and low-dose prednisolone are effective modes of therapy for RAS .


Substance use disorder ( SUD ) is a major health issue , especially among military veterans .


We previously reported the effects of auricular acupuncture and the relaxation response ( RR ) on reducing craving and anxiety following 10-week interventions among veterans who were in recovery from SUDs .


Our current analysis examines effects following each intervention session and RR daily practice .


We conducted a three-arm randomized controlled trial on residents of a homeless veteran rehabilitation program .


Sixty-Seven enroled participants were randomly assigned to acupuncture ( n = 23 ) , RR ( n = 23 ) , or usual care ( n = 21 ) .


Participants in the two intervention groups rated their degree of craving for substance on a scale of 1-10 and anxiety levels on a scale of 1-4 ( total score 20-80 ) before and after each intervention session .


Mixed effects regression models were used for analysis .


Craving and anxiety levels decreased significantly following one session of acupuncture ( -1.04 , p = .0001 ; -8.83 , p < .0001 ) or RR intervention ( -.43 , p = .02 ; -4.64 , p = .03 ) .


The level of craving continued to drop with additional intervention sessions ( regression coefficient b = -.10 , p = .01 , and b = -.10 , p = .02 for acupuncture and RR groups , respectively ) .


Number of daily practice days of RR-eliciting techniques is also associated with reduction in craving ratings ( b = -.02 , p = .008 ) .


Findings demonstrate the value of attending regular acupuncture and RR-eliciting intervention sessions , as well as the daily practice of RR-eliciting techniques .


Substance addiction is a complex disease and effective treatment remains a challenge .


Our study findings add to the scientific evidence of these two non-pharmaceutical approaches for SUD .


An estimated 100 million people have symptomatic dengue infection every year .


This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine .


We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic , virologically confirmed dengue in children .


We did an observer-masked , randomised controlled , multicentre , phase 3 trial in five countries in the Asia-Pacific region .


Between June 3 , and Dec 1 , 2011 , healthy children aged 2-14 years were randomly assigned ( 2:1 ) , by computer-generated permuted blocks of six with an interactive voice or web response system , to receive three injections of a recombinant , live , attenuated , tetravalent dengue vaccine ( CYD-TDV ) , or placebo , at months 0 , 6 , and 12 .


Randomisation was stratified by age and site .


Participants were followed up until month 25 .


Trial staff responsible for the preparation and administration of injections were unmasked to group allocation , but were not included in the follow-up of the participants ; allocation was concealed from the study sponsor , investigators , and parents and guardians .


Our primary objective was to assess protective efficacy against symptomatic , virologically confirmed dengue , irrespective of disease severity or serotype , that took place more than 28 days after the third injection .


The primary endpoint was for the lower bound of the 95 % CI of vaccine efficacy to be greater than 25 % .


Analysis was by intention to treat and per procotol .


This trial is registered with ClinicalTrials.gov , number NCT01373281 .


We randomly assigned 10,275 children to receive either vaccine ( n = 6851 ) or placebo ( n = 3424 ) , of whom 6710 ( 98 % ) and 3350 ( 98 % ) , respectively , were included in the primary analysis .


250 cases of virologically confirmed dengue took place more than 28 days after the third injection ( 117 [ 47 % ] in the vaccine group and 133 [ 53 % ] in the control group ) .


The primary endpoint was achieved with 565 % ( 95 % CI 438-664 ) efficacy .


We recorded 647 serious adverse events ( 402 [ 62 % ] in the vaccine group and 245 [ 38 % ] in the control group ) .


54 ( 1 % ) children in the vaccine group and 33 ( 1 % ) of those in the control group had serious adverse events that happened within 28 days of vaccination .


Serious adverse events were consistent with medical disorders in this age group and were mainly infections and injuries .


Our findings show that dengue vaccine is efficacious when given as three injections at months 0 , 6 , and 12 to children aged 2-14 years in endemic areas in Asia , and has a good safety profile .


Vaccination could reduce the incidence of symptomatic infection and hospital admission and has the potential to provide an important public health benefit .


Sanofi Pasteur .


This study aimed 1 ) to quantify the strength of patient preferences for different aspects of early assisted discharge in The Netherlands for patients who were admitted with a chronic obstructive pulmonary disease exacerbation and 2 ) to illustrate the benefits of latent class modeling of discrete choice data .


This technique is rarely used in health economics .


Respondents made multiple choices between hospital treatment as usual ( 7 days ) and two combinations of hospital admission ( 3 days ) followed by treatment at home .


The latter was described by a set of attributes .


Hospital treatment was constant across choice sets .


Respondents were patients with chronic obstructive pulmonary disease in a randomized controlled trial investigating the cost-effectiveness of early assisted discharge and their informal caregivers .


The data were analyzed using mixed logit , generalized multinomial logit , and latent-class conditional logit regression .


These methods allow for heterogeneous preferences across groups , but in different ways .


Twenty-five percent of the respondents opted for hospital treatment regardless of the description of the early assisted discharge program , and 46 % never opted for the hospital .


The best model contained four latent classes of respondents , defined by different preferences for the hospital and caregiver burden .


Preferences for other attributes were constant across classes .


Attributes with the strongest effect on choices were the burden on informal caregivers and co-payments .


Except for the number of visits , all attributes had a significant effect on choices in the expected direction .


Considerable segments of respondents had fixed preferences for either treatment option .


Applying latent class analysis was essential in quantifying preferences for attributes of early assisted discharge .


Polio eradication remains a challenge in Pakistan and the causes for the failure to eradicate poliomyelitis are complex .


Undernutrition and micronutrient deficiencies , especially zinc deficiency , are major public health problems in Pakistan and could potentially affect the response to enteric vaccines , including oral poliovirus vaccine ( OPV ) .


To assess the impact of zinc supplementation among infants on immune response to oral poliovirus vaccine ( OPV ) .


A double-blind , randomized placebo-controlled trial was conducted in newborns ( aged 0-14 days ) .


Subjects were assigned to either receive 10mg of zinc or placebo supplementation daily for 18 weeks .


Both groups received OPV doses at birth , at 6 weeks , 10 weeks and 14 weeks .


Data was collected on prior immunization status , diarrheal episodes , breastfeeding practices and anthropometric measurements at recruitment and at 6 and 18 weeks .


Blood samples were similarly collected to determine the antibody response to OPV and for micronutrient analysis .


Logistic regression was used to determine the relationship between seroconversion and zinc status .


Overall , 404 subjects were recruited .


At recruitment , seropositivity was already high for poliovirus ( PV ) serotype 1 ( zinc : 91.1 % ; control : 90.5 % ) and PV2 ( 90.0 % ; 92.7 % ) , with lower estimates for PV3 ( 70.0 % ; 64.8 % ) .


By week 18 , the proportion of subjects with measured zinc levels in the normal range ( i.e. 60 g/dL ) was significantly greater in the intervention group compared to the control group ( 71.9 % ; 27.4 % ; p < 0.001 ) .


No significant difference in seroconversion was demonstrated between the groups for PV1 , PV2 , or PV3 .


There was no effect of zinc supplementation on OPV immunogenicity .


These conclusions were confirmed when restricting the analysis to those with measured higher zinc levels .


To evaluate the efficacy and safety of tacrolimus mouth rinse on the treatment of erosive and ulcerative oral lichen planus ( OLP ) .


A randomized single-blind open trial of tacrolimus mouth rinse with dexamethasone as control was designed .


The VAS and REU scoring system was utilized to compare the signs and symptoms .


The scores and therapeutic effects were analyzed with SPSS 17.0 software package .


There was no significant difference in effective rate between the treatment group and control group ( X ( 2 ) = 0.295,0.413 , P > 0.01 ) at 4-week and 12-week after treatment .


There was significant difference in REU scores between the 2 groups ( P < 0.01 ) 4 weeks after treatment .


Tacrolimus mouth rinse effects quickly and is worthy of application in the treatment of erosive and ulcerative OLP .


This double-blind sham-controlled crossover study investigated the interactions between primary sensory and motor cortex after stroke and their response to Theta Burst Stimulation ( TBS ) .


Thirteen chronic subcortical stroke patients with upper limb impairment performed standardised dexterity training primed with ipsilesional M1 intermittent TBS ( iTBSiM1 ) , contralesional M1 continuous TBS ( cTBScM1 ) or sham TBS .


The effects on sensorimotor integration , corticomotor excitability , sensation and grip-lift kinetics were examined .


After iTBSiM1 , improvements in paretic grip-lift performance were accompanied by an immediate facilitation of ipsilesional M1 excitability and a subsequent increase in ipsilesional short latency afferent inhibition ( SAI ) during training .


Precision grip-lift performance improved after cTBScM1 and training , alongside increased ipsilesional M1 excitability with no effect on ipsilesional SAI .


There were no effects on sensory performance .


Primary motor cortex iTBS not only modulates M1 corticospinal excitability but also increases M1 receptiveness to sensory input .


Priming with iTBSiM1 may enhance ipsilesional sensorimotor integration and facilitate better quality sensorimotor training after subcortical stroke .


To evaluate the analgesic effect of pregabalin combined with intrathecal sufentanil infusion for the treatment of breakthrough pain in patients with bone metastases .


A total of 60 breakthrough pain patients with bone metastases were randomly divided to 3 groups : group A ( pregabalin combined with intrathecal sufentanil infusion group , n = 20 ) , group B ( placebo combined with intrathecal sufentanil infusion group , n = 20 ) and group C ( oral morphine sulfate controlled-release tablet group , n = 20 ) .


The differences in visual analogue scale ( VAS ) between background pain and breakthrough pain , the seizure frequency of breakthrough pain , general satisfaction and side effects of the 3 groups were observed .


The seizure frequency and VAS of breakthrough pain in group A decreased significantly after the treatment ( P < 0.05 ) and the general satisfaction was the best among the the 3 groups ( P < 0.05 ) , with less nausea and vomiting , constipation , drowsiness and fewer other side effects .


Pregabalin combined with intrathecal sufentanil infusion can effectively relieve breakthrough pain in patients with bone metastases .


Durability of good glycaemic control ( HbA1c ) is of importance as it can be the foundation for delaying diabetic complications .


It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents .


Dipeptidyl peptidase-4 inhibitors are good candidates for early use as they are efficacious in combination with metformin , show weight neutrality and a low risk of hypoglycaemia .


We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows - cell deterioration as measured by HbA1c .


Approximately 2000 people with Type 2 diabetes mellitus who were drug-naive or who were treated with metformin for less than 1 month , and who have HbA1c of 48-58 mmol/mol ( 6.5-7 .5 % ) , will be randomized in a 1:1 ratio in VERIFY , a 5-year multinational , double-blind , parallel-group study designed to compare early initiation of a vildagliptin-metformin combination with standard-of-care initiation of metformin monotherapy , followed by the stepwise addition of vildagliptin when glycaemia deteriorates .


Further deterioration will be treated with insulin .


The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints .


VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria .


To determine the effects of participation in a 2-year community-based dance class on disease severity and functional mobility in people with Parkinson disease ( PD ) .


Randomized controlled trial .


Dance classes took place in a community-based location .


Outcome measures were collected in a university laboratory .


Ten individuals with PD were randomly assigned to the Argentine tango ( AT ) group ( n = 5 [ 4 men ] ; mean agestandard deviation , 69.66.6 years ) or the control group ( n = 5 [ 4 men ] ; mean agestandard deviation , 6611.0 years ) .


The AT group participated in a community-based AT class for 1 hour twice weekly for 2 years .


Control group participants were given no prescribed exercise .


Blinded assessments occurred at baseline and 12 and 24 months .


Movement Disorder Society-Unified Parkinson Disease Rating Scale ( MDS-UPDRS ) III , Mini-Balance Evaluation Systems Test ( Mini-BESTest ) , gait velocity ( forward and backward ) , Timed Up and Go and dual-task Timed Up and Go , Six-Minute Walk Test ( 6MWT ) , MDS-UPDRS II , MDS-UPDRS I , and Freezing of Gait Questionnaire .


There were no differences between groups at baseline .


A significant group-by-time interaction ( F [ 2,8 ] = 17.59 ; p < 0.0001 ) was noted for the MDS-UPDRS III , with the AT group having lower scores at 12 and 24 months than the controls .


Significant interactions were also noted for the Mini-BESTest , MDS-UPDRS II and I , and 6MWT .


This is believed to be one of the longest-duration studies to examine the effects of exercise on PD .


Participation in community-based dance classes over 2 years was associated with improvements in motor and nonmotor symptom severity , performance on activities of daily living , and balance in a small group of people with PD .


This is noteworthy given the progressive nature of PD and the fact that the control group declined on some outcome measures over 2 years .


Falls are the most frequent adverse events that are reported in hospitals .


We examined the effectiveness of individualised falls-prevention education for patients , supported by training and feedback for staff , delivered as a ward-level programme .


Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge , cluster-randomised study , undertaken during a 50 week period .


Units were randomly assigned to intervention or control groups by use of computer-generated , random allocation sequences .


We included patients admitted to the unit during the study with a Mini-Mental State Examination ( MMSE ) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional , in addition to usual care .


We provided information about patients ' goals , feedback about the ward environment , and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients .


The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers .


All analyses were by intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials registry , number ACTRN12612000877886 ) .


Between Jan 13 , and Dec 27 , 2013 , 3606 patients were admitted to the eight units ( n = 1983 control period ; n = 1623 intervention period ) .


There were fewer falls ( n = 196 , 780/1000 patient-days vs n = 380 , 1378/1000 patient-days , adjusted rate ratio 060 [ robust 95 % CI 042-094 ] , p = 0003 ) , injurious falls ( n = 66 , 263/1000 patient-days vs 131 , 475/1000 patient-days , 065 [ robust 95 % CI 042-088 ] , p = 0006 ) , and fallers ( n = 136 [ 838 % ] vs n = 248 [ 1251 % ] adjusted odds ratio 055 [ robust 95 % CI 038 to 081 ] , p = 0003 ) in the intervention compared with the control group .


There was no significant difference in length of stay ( intervention median 11 days [ IQR 7-19 ] , control 10 days [ 6-18 ] ) .


Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units .


State Health Research Advisory Council , Department of Health , Government of Western Australia .


Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses .


This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents , thiopentone sodium and propofol , and also to compare the undesired responses occurring during LMA insertion with them .


The study was prospective , randomized , and double blind .


All patients selected were randomly allocated into two groups : Group 1 ( propofol ) and group II ( thiopentone ) .


Preinduction heart rate and blood pressure were recorded .


Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II , to undergo surgery less than 1 h , were selected for the study-Patients were randomly allocated in two groups , 30 in each group .


Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups .


Thereafter , group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium .


The study revealed that , ease of insertion of LMA , was statistically significantly greater in group 1 when compared with group 2 ( P 0.05 ) .


The time required for successful insertion of LMA was lesser in group 1 patients ( 53.8 7.77 s ) than in group 2 patients ( 84.7 16.54 s ) ( P 0.001 ) .


Severity of undesired responses were more in group 2 , as incremental boluses of respective induction agents were required in 20 % patients in thiopentone group compared to only 6 % patients in propofol group and 13 % of patients in thiopentone group required rescue succinylcholine .


South Africa has a high and rising prevalence of hypertension .


Many affected individuals are not using medication , and few have controlled blood pressure .


Until recently , primary care clinics focused on maternal and child health and management of acute conditions , but new government initiatives have shifted the focus to chronic diseases , including HIV/AIDS and hypertension .


The Nkateko trial will test the effectiveness of clinic-based lay health workers ( LHWs ) in supporting hypertension management .


It is a pragmatic , cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa , and it is underpinned by long-term health and demographic surveillance .


Eight primary care facilities , with their catchment communities , are randomised to usual care or the addition of LHWs focused on chronic care .


All clinics ( intervention and control ) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records .


Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions , particularly hypertension .


The LHWs will be supported by an implementation manager , who will work with clinic staff to develop the most effective role for the LHWs .


Control clinics will continue to provide usual care .


The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease .


A process evaluation will be based on a realist approach using patient exit interviews , clinic observations and interviews with health professionals , LHWs and patients to document the intervention and its implementation .


There are challenges in the design of this trial .


Assessing change through population surveys may reduce measurable effects ; however , we feel this is appropriate because we aim to attract those who currently do not use clinics , and we hope to improve care for clinic users .


Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community .


We are constantly working to achieve an effective balance between the intervention and process evaluations .


ISRCTN12128227 ( registered 5 March 2014 ) .


Little evidence exists on whether effects of an early obesity intervention are sustainable .


To assess the sustainability of effects of a home-based early intervention on children 's body mass index ( BMI ) and BMI z score at 3 years after intervention .


A longitudinal follow-up study of the randomized clinical Healthy Beginnings Trial was conducted with 465 participating mothers consenting to be followed up at 3 years after intervention until their children were age 5 years .


This study was conducted in socially and economically disadvantaged areas of Sydney , Australia , from March 2011 to June 2014 .


No further intervention was carried out in this Healthy Beginnings Trial phase 2 follow-up study .


The original intervention in phase 1 comprised 8 home visits from community nurses delivering a staged home-based intervention , with one visit in the antenatal period and 7 visits at 1 , 3 , 5 , 9 , 12 , 18 , and 24 months after birth .


Primary outcomes were children 's BMI and BMI z score .


Secondary outcomes included dietary behaviors , quality of life , physical activity , and TV viewing time of children and their mothers .


In total , 369 mothers and their children completed the follow-up study , a phase 2 completion rate of 79.4 % ( 80.9 % for the intervention group and 77.7 % for the control group ) .


The differences between the intervention and control groups at age 2 years in children 's BMI and BMI z score disappeared over time .


At age 2 years , the difference ( intervention minus control ) in BMI ( calculated as weight in kilograms divided by height in meters squared ) was -0.41 ( 95 % CI , -0.71 to -0.10 ; P = .009 ) , but by age 5 years it was 0.03 ( 95 % CI , -0.30 to 0.37 ) .


No effects of the early intervention on dietary behaviors , quality of life , physical activity , and TV viewing time were detected at age 5 years .


The significant effect of this early life home-visiting intervention on child BMI and BMI z score at age 2 years was not sustained at age 5 years without further intervention .


Obesity prevention programs need to be continued or maintained during the early childhood years .


Changes in gut motor and hormonal function contribute to the eating-inhibitory and glucose-lowering effects of protein .


The effect of amino acids , the digestive products of protein , on gastrointestinal function , eating , and glycemia has not been investigated comprehensively .


We tested the hypothesis that L-tryptophan ( L-Trp ) stimulates gastrointestinal motor and hormonal functions , inhibits eating , and modulates glycemia .


Design , Settings , Participants , and Intervention : Ten healthy , normal-weight men were studied in randomized , double-blind fashion , each receiving a 90-minute intraduodenal infusion of L-Trp at 0.075 ( total 6.75 kcal ) or 0.15 ( total 13.5 kcal ) kcal/min or saline ( control ) .


Antropyloroduodenal motility , plasma ghrelin , cholecystokinin , glucagon-like peptide-1 , peptide tyrosine tyrosine , insulin , glucagon , blood glucose , and appetite perceptions were measured .


Food intake was quantified from a buffet meal after the infusion .


Intraduodenal L-Trp suppressed antral pressures ( P < .05 ) and stimulated pyloric pressures ( P < .01 ) and markedly increased cholecystokinin and glucagon ( both P < .001 ) .


Glucagon-like peptide-1 and peptide tyrosine tyrosine increased modestly ( both P < .001 ) , but there was no effect on total ghrelin .


Insulin increased slightly ( P < .05 ) without affecting blood glucose .


Plasma L-Trp increased substantially ( P < .001 ) .


All effects were dose-related and associated with increased fullness and substantially decreased energy intake ( P < .001 ) .


There was a strong inverse correlation between energy intake and plasma L-Trp ( r = -0.70 ; P < .001 ) .


Low caloric intraduodenal loads of L-Trp affect gut motor and hormonal function and markedly reduce energy intake .


A strong inverse correlation between energy intake and plasma L-Trp suggests that , beyond gut mechanisms , direct effects of circulating L-Trp mediate its eating-inhibitory effect .


To examine characteristics of ocular hypertensive subjects and potential associations with estimated cerebrospinal fluid pressure ( estCSFP ) .


The population-based Beijing Eye Study 2011 included 3468 individuals with a mean age of 64.69.8 years .


Ocular hypertension was defined as intraocular pressure ( IOP ) > 21 mmHg , normal optic nerve head appearance and normal retinal nerve fiber layer thickness .


IOP was corrected for its dependence on central corneal thickness ( CCT ) and corneal curvature radius .


Estimated CSFP was calculated as CSFP [ mmHg ] = 0.44 Body Mass Index [ kg/m2 ] +0.16 Diastolic Blood Pressure [ mmHg ] -0.18 Age [ Years ] -1.91 .


Estimated trans-lamina cribrosa pressure difference ( estTLCPD ) was IOP-estCSFP .


EstCSFP ( 10.53.6 mmHg versus 9.03.7 mmHg ; P = 0.003 ) and estTLCPD ( 12.04.4 mmHg versus 5.43.8 mmHg ; P < 0.001 ) were higher in the ocular hypertensive group than in the normotensive group .


In binary regression analysis , ocular hypertension was associated with increased estCSFP ( P = 0.03 ; odds ratio ( OR ) : 1.08 ; 95 % confidence interval ( CI ) : 1.01 , 1.17 ) after adjusting for prevalence of arterial hypertension ( P = 0.07 ; OR : 1.79 ; 95 % CI : 0.96 , 3.34 ) , retinal nerve fiber layer thickness ( P = 0.03 ; OR : 0.97 ; 95 % CI : 0.95 , 0.997 ) and blood glucose concentration ( P = 0.006 ; OR : 1.17 ; 95 % CI : 1.04 , 1.30 ) .


Ocular hypertensive subjects ( with IOP correction for CCT and corneal curvature ) as compared to ocular normotensive subjects had a significantly higher estCSFP in univariate analysis and in multivariate analysis .


Despite of a higher estCSFP , estTLCPD was still markedly higher in ocular hypertensive eyes than in ocular normotensive eyes .


Compare the effect of financial incentives on response to a cancer survivors ' postal questionnaire .


Prostate cancer survivors in Ireland , 1.5-18 years after diagnosis , were randomized to the ( 1 ) `` lottery '' arm [ a 1 lottery scratch card sent with the questionnaire ( n = 2,413 ) ] or ( 2 ) `` prize '' arm [ entry into a draw on return of a completed questionnaire ( n = 2,407 ) ] .


Impact of interventions on response overall and by survival period ( `` short term '' : < 5 years after diagnosis ; `` long term '' : 5 years after diagnosis ) was compared as was cost-effectiveness .


Adjusted response rate was 54.4 % .


Response was higher among younger men ( P < 0.001 ) and those with earlier stage disease ( P = 0.002 ) .


A modest 2.6 % higher response rate was observed in the lottery compared with the prize arm [ multivariate relative risk ( RR ) = 1.06 ; 95 % confidence interval ( CI ) : 1.00 , 1.11 ] .


When stratified by survival period , higher response in the lottery arm was only observed among long-term survivors ( multivariate RR = 1.10 ; 95 % CI : 1.02 , 1.19 ; short-term survivors : RR = 1.01 ; 95 % CI : 0.94 , 1.09 ) .


Costs per completed questionnaire were 4.54 and 3.57 for the lottery and prize arms , respectively .


Compared with the prize arm , cost per additional questionnaire returned in the lottery arm was 25.65 .


Although more expensive , to optimize response to postal questionnaires among cancer survivors , researchers might consider inclusion of a lottery scratch card .


To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes .


This was a randomized , examiner-blind , parallel-group , two-treatment clinical trial of two weeks ' duration .


Subjects qualified for the study if they had an average Modified Lobene Stain Index of 1.5 from two anterior teeth .


At baseline , subjects brushed in front of a mirror for one minute under supervision .


All subjects were provided with a standard 0.243 % sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush ( OBP ) or a Colgate Whitening manual brush ( CW ) to use for two weeks .


Stain was reassessed after two weeks of product use .


Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index , which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index .


Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use .


Median stain reductions were 78 % and 60 % for the OBP and CW , respectively , as measured by the Modified Lobene Stain Index .


The mean changes in the composite scores from baseline to week two were 1.85 and 1.57 for the two treatment groups , respectively .


Statistically significant reductions from baseline were also found for the intensity and extent of stain measures ( p < 0.001 ) .


Similar trends were found using the new Interproximal Modified Lobene Index .


Composite median stain removal percentages versus baseline were 88 % and 73 % for the OBP and CW groups , respectively ( p < 0.001 ) .


For the interproximal sites , a median stain removal of 92 % was observed with the OBP brush and 83 % reduction with the CW brush .


For the gingival sites , the median stain removal percentages were 83 % and 50 % , respectively For the body region , a median stain removal of 100 % was found for both treatment groups .


No statistically significant differences were found between the two groups for the mean composite scores for either index .


Both manual brushes showed effective stain removal , including interproximal hard-to-reach sites .


The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index , while allowing assessment of interproximal regions .


Patients undergoing both rigid and flexible cystoscopic evaluation suffer from a great deal of pain and discomfort .


In this study , we aimed to investigate the effect of lidocaine gel anestesia on patient comfort on diagnostic rigid cystoscopy .


11 mL of lubricant gel applied to each patient via the external meatus in 10 s. Patients were randomized into three groups .


In group 1 , liquid glycerine was applied and cystoscopy was immediately performed , in group 2 lidocaine gel ( Aqua Touch : stem Tbbi Cihaz Ve Sanayi Ltd.ti , Ostim , Ankara , Trkiye ) was applied and the procedure undergone immediately and in group 3 , lidocaine gel was applied and penis was clemped for 10 minutes before the procedure .


VAS forms were filled to determine the discomfort and pain during cystoscopy and the first micturation after .


After the evaluation between groups , VAS scores were significantly lower in Group II and III than Group I and in Group III than in Group II ( p < 0.05 ) .


When post micturation VAS scores were evaluated , VAS scores were significantly lower in Group II than Group I and in Group III than in Group II ( p < 0.05 ) .


The application of local anesthetic lidocaine gel in rigid cystoscopy , is a practical , safe and efficient method to improve patient comfort when applied in appropriate dose and waiting duration .


For patients with clinically significant risk of febrile neutropenia , pegfilgrastim administration should occur the day after myelosuppressive chemotherapy ; however , a variety of factors may preclude patients from returning to the clinic the next day for pegfilgrastim administration , necessitating other strategies .


This study compared the pharmacokinetics and safety of pegfilgrastim administered via an on-body injector applied to the subject 's skin versus manual injection using a prefilled syringe .


Healthy subjects aged 18-50years were randomized 1:1 to receive a single 6-mg subcutaneous pegfilgrastim dose from an on-body injector or a prefilled syringe .


Blood for pharmacokinetic measurements was collected at baseline and prespecified time points after pegfilgrastim administration ; safety was assessed throughout the 6-week study .


Primary endpoints were maximum concentration ( C max ) and area under the concentration curve from time 0 to infinity ( AUC0-inf ) .


Secondary endpoints included safety , tolerability , and immunogenicity .


Pegfilgrastim mean AUC0-inf values for the on-body injector ( n = 125 ) and manual injection ( n = 128 ) were 10,900 and 11,100 hng/mL , respectively ; mean C max values were 248 and 262ng/mL , respectively .


The least squares geometric mean ratios were 0.97 for C max and 1.00 for AUC0-inf ; the corresponding 90 % CIs were within the prespecified range ( 0.80-1 .25 ) , indicating comparable pegfilgrastim pharmacokinetics between delivery methods .


Treatment-emergent adverse events ( AEs ) were similar between groups ( injector , 86 % ; manual , 85 % ) .


Injector - or syringe-related AEs were more prevalent with the injector ( 13 % ; manual , 4 % ) ; none were serious .


No pegfilgrastim-neutralizing antibodies were detected .


Pegfilgrastim pharmacokinetics and safety were comparable between the on-body injector and manual injection groups .


Although single , high doses of vitamin D effectively maintain vitamin D sufficiency in several populations , no studies have evaluated healthy adults over winter , during which vitamin D status declines .


This study investigated whether high-dose vitamin D3 given once to healthy adults before winter will ( 1 ) prevent the wintertime decline in vitamin D status , ( 2 ) promote vitamin D sufficiency 1 year following the dose and ( 3 ) prevent the rise of parathyroid hormone ( PTH ) concentrations .


In this double-blind , placebo-controlled trial , we assessed plasma 25 ( OH ) D and PTH concentrations at baseline , 5 , 90 and 365 days after drug administration in 28 healthy adults .


In all , > 80 % of subjects returned at each time point .


At baseline , the young , healthy participants had a mean plasma 25 ( OH ) D concentration of 17.56.1 ng/ml .


Only two subjects exhibited plasma 25 ( OH ) D concentrations > 30ng/ml .


At 5 days , subjects randomized to vitamin D3 had a higher mean plasma 25 ( OH ) D concentration compared with the placebo group ( 39.1 vs 19.1 ng/ml , P < 0.001 ) .


Plasma 25 ( OH ) D concentrations returned to baseline at 90 and 365 days in the vitamin D3 group and remained unchanged in the placebo group .


PTH and calcium concentrations were unrelated to changes in 25 ( OH ) D levels and similar between groups over time .


A dose of 250,000 IU of vitamin D3 given once in November resulted in a robust increase in plasma 25 ( OH ) D after 5 days , but it was unable to sustain this increase after 90 days .


A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency .


We sought to determine the association of dietary factors and risk of cognitive decline in a population at high risk of cardiovascular disease .


Baseline dietary intake and measures of the Mini-Mental State Examination were recorded in 27,860 men and women who were enrolled in 2 international parallel trials of the ONTARGET ( Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial ) and TRANSCEND ( Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease ) studies .


We measured diet quality using the modified Alternative Healthy Eating Index .


Cox proportional hazards regression was used to determine the association between diet quality and risk of 3-point decline in Mini-Mental State Examination score , and reported as hazard ratio with 95 % confidence intervals with adjustment for covariates .


During 56 months of follow-up , 4,699 cases of cognitive decline occurred .


We observed lower risk of cognitive decline among those in the healthiest dietary quintile of modified Alternative Healthy Eating Index compared with lowest quintile ( hazard ratio 0.76 , 95 % confidence interval 0.66-0 .86 , Q5 vs Q1 ) .


Lower risk of cognitive decline was consistent regardless of baseline cognitive level .


We found that higher diet quality was associated with a reduced risk of cognitive decline .


Improved diet quality represents an important potential target for reducing the global burden of cognitive decline .


Insufficient data exist regarding postoperative thoracic epidural analgesia for morbidly obese patients undergoing open bariatric surgery .


This study evaluated the effectiveness of morphine loading in a postoperative thoracic epidural analgesic regimen of patient-controlled epidural analgesia ( PCEA ) with levobupivacaine combined with continuously administered epidural morphine in this patient group .


In this prospective randomized controlled trial , 48 superobese patients ( body mass index of 50 kg/m ( 2 ) ) undergoing open bariatric surgery were randomly allocated to three groups of 16 patients each .


Postoperatively , all groups received a continuous epidural morphine infusion of 0.2 mg/h with 0.1 % levobupivacaine via PCEA .


Group A did not receive intraoperative epidural morphine loading , while groups B and C received an intraoperative 1 - and 2-mg morphine bolus , respectively .


Levobupivacaine consumption via PCEA ( primary outcome ) , pain scores at rest and on cough , the time to return of bowel function and ambulation , and arterial blood gas levels ( secondary outcomes ) were recorded .


The increase in perioperative morphine administration ( groups B and C ) led to a significantly prolonged return to normal bowel function and delayed ambulation ( P < 0.05 to 0.01 , respectively ) , without an improvement in postoperative analgesia or a reduction in local anesthetic consumption .


Although the prevalence of obstructive sleep apnea ( OSA ) was high in all groups , no respiratory depression was observed .


Thoracic PCEA with 0.1 % levobupivacaine combined with continuous epidural morphine administration of 0.2 mg/h without morphine loading is an effective postoperative analgesic regimen that provides adequate pain control , early ambulation , and early return of bowel function in superobese patients , particularly those with OSA .


Anxiety is a prominent symptom in anorexia nervosa ( AN ) , and higher pre-meal anxiety has been associated with lower caloric intake .


Yet , the causal relationship has not been assessed .


We proposed that reducing anxiety with a short acting benzodiazepine would increase caloric intake among individuals with AN .


In a randomized , double-blind , placebo controlled cross-over study , we administered alprazolam 0.75 mg to inpatients with AN ( n = 17 ) and assessed caloric intake in a laboratory test meal .


Within-subject differences in caloric intake , anxiety , and fatigue were compared between alprazolam and placebo days .


Caloric intake did not differ on alprazolam versus placebo ( t ( 15 ) = 1.72 , p = .11 ) .


Alprazolam did not reduce anxiety , but was associated with increased fatigue .