Secondary outcome measures were perceived ease of use and feasibility of VL and DL ETI modalities .


Twenty-one of 23 ( 91.3 % ) eligible residents participated .


Mean time to ETI was 10.0 seconds ( SD = 5.3 seconds ) in the DL group and 7.8 seconds ( SD = 3.0 seconds ) in the VL group ( P = .081 ) .


Mean times from blade insertion until BVM attachment were 17.4 seconds ( SD = 6.0 seconds ) and 15.6 seconds ( SD = 4.6 seconds ) , respectively ( P = .30 ) .


There were no unsuccessful intubation attempts .


Seventeen out of 20 participants ( 85.0 % ) perceived VL to be easier to use when performing ETI in PPE .


Twelve out of 20 participants ( 60 % ) perceived DL to be more feasible in an actual HazMat scenario .


The time to successful ETI was not significantly different between VL and DL .


Video laryngoscopy had a greater perceived ease of use , but DL was perceived to be more feasible for use in actual HazMat situations .


These findings suggest that both DL and VL are reasonable modalities for use in HazMat situations , and the choice of modality could be based on the clinical situation and provider experience .


Although quantitative right ventricular ( RV ) strain analysis may be useful in congenital and acquired heart disease populations with RV failure , a comprehensive , standardized approach is lacking .


An 18-segment RV strain analysis obtained from three standardized RV apical echocardiographic images was used to determine the feasibility , normal values , and reproducibility of the method in normal adults .


Forty healthy , prospectively enrolled volunteers with no cardiac histories and normal QRS durations underwent echocardiography optimized for strain analysis including three RV apical views .


Two-dimensional speckle-tracking longitudinal strain analysis was performed using EchoPAC software .


Eleven retrospectively identified subjects with RV disease were included as a pilot population .


All had been imaged using the same protocol including the three RV apical views .


All control subjects had normal anatomic morphology and function by echocardiography .


Feasibility of the RV strain analysis was good ( adequate tracking in 696 of 720 segments [ 97 % ] ) .


RV global peak systolic strain was -23 2 % .


Peak strain was highest in the RV free wall and lowest in the septum .


Dyssynchrony indices demonstrated no dyssynchrony using left ventricular criteria .


Reproducibility of most strain measures was acceptable .


This methodology identified important disease not seen in the four-chamber apical view alone in the pilot population of 11 patients with RV disease .


Strain patterns and values were different from those in the control population , indicating that differences do exist from normal .


Eighteen-segment RV strain analysis is feasible , with strain measures falling into discrete ranges in this normal population .


Those with RV disease illustrate the potential utility of this approach .


These data indicate that this model can be used for more detailed studies evaluating abnormal RV populations , in which its full potential can be assessed .


Hypovitaminosis D is particularly common among older people with a proximal femoral ( hip ) fracture .


There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery .


The REVITAHIP Study is a multisite , double-blinded randomized-controlled trial investigating the effects of an oral vitamin D loading dose on gaitvelocity after hip fracture surgery .


We describe the baseline characteristics of participants , aiming to document hypovitaminosis D and its associations after hip fracture .


Participants , over 65 , recruited within 7 days following hip fracture surgery from 3 Australia hospitals , were randomly allocated to receive a loading dose of vitamin D3 ( 250,000 IU ) or placebo , followed by oral maintenance vitamin D3/calcium ( 800 IU/500 mg ) and the usual hip fracture rehabilitation pathway.Demographic and clinical data were collected , including surgical procedure , pre-fracture functional status , Mini Mental State Examination ( MMSE ) score , serum 25-hydroxyvitamin D ( 25-OHD ) , Verbal Rating Scale ( VRS ) for pain , grip strength and gait velocity .


The associations of baseline 25-OHD levels with demographic and clinical data were assessed using Pearson 's correlation , ANOVA and regression analyses .


Two-hundred-and-eighteen people with hip fracture participated in the study .


Mean age was 83.9 + / -7.2 years , 77 % were women and 82 % lived in privatehomes .


Fifty-six percent had a subcapital fracture .


Mean comorbidity count was 3.13 + / -2.0 .


Mean MMSE was 26.1 + / -3.9 .


Forty-seven percent of participants had hypovitaminosis D ( < 50 nmol/L ) .


Multivariate regression models demonstrated higher baseline vitamin D levels were significantly associated with higher premorbid Barthel index scores , lower post-operative VRS pain levels and use of vitamin D.


This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture , with the probable exception of less cognitive impairment .


Hypovitaminosis D was not as prevalent as previously documented .


Patients taking vitamin D supplements and with higher premorbid Barthel index , reflecting greater independence and activity , tended to have higher 25-OHD levels at baseline .


Further , lower VRS pain ratings following surgery were associated with higher vitamin D levels .


Such associations will need further investigation to determine causation .


( ANZCTR number , ACTRN12610000392066 ) .


The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ANZCTRN ACTRN12610000392066 .


To evaluate the effectiveness of a desensitizing gel for topical and home use for the treatment of dentin hypersensitivity ( DH ) by means of a 3-arm parallel , randomized , double blind clinical trial .


107 participants were allocated to three groups : placebo gel ( PG ) , test gel ( TG ) ( 5 % sodium fluoride , 5 % potassium oxalate , 10 % strontium chloride ) and 2 % sodium fluoride gel ( FG ) .


DH measurement was performed by a single blind examiner by means of the visual analog scale ( VAS ) after tactile ( blunt tipped probe ) , thermal ( air blast ) and osmotic ( water blast ) stimulus at time intervals of baseline , 7 , 15 and 30 days .


The greatest reductions in DH were observed for the TG , with significant differences for FG in the thermal ( = -56 vs -30 ) and osmotic stimuli ( = -44 vs -18 ) .


Considering the percentage of participants with moderate/severe pain at 30 days , the TG demonstrated the lowest percentages , with significant differences in comparison with the other groups in thermal and osmotic stimuli .


We can conclude that the test gel showed a greater reduction in DH than fluoride 2 % and placebo gel , and maybe a treatment option for individuals with DH .


Morbidly obese patients are at high risk for perioperative complications , including surgical site infections .


Baseline arterial oxygenation is low in the morbidly obese , leading to low tissue oxygenation , which in turn is a primary determinant of infection risk .


We therefore tested the hypothesis that extending intraoperative supplemental oxygen 12 to 16 hours into the postoperative period reduces the risk of surgical site infection and healing-related complications .


Morbidly obese patients having open or laparoscopic bariatric surgery were given 80 % inspired oxygen intraoperatively .


Postoperatively , patients were randomly assigned to either 2 L/min of oxygen via nasal cannula or approximately 80 % supplemental inspired oxygen after tracheal extubation until the first postoperative morning .


The risks of surgical site infection and of major healing-related complications were evaluated 60 days after surgery .


In a preplanned interim analysis based on the initial 400 patients , the overall observed incidence of the collapsed composite of major complications was 13.3 % ; the observed incidence of components of the composite outcome ranged from 0 % ( peritonitis ) to 8.5 % ( surgical wound infection ) .


The estimated relative risk of any 1 major complications occurring within the first 60 days after surgery , adjusting for study site , was 0.94 ( 95 % confidence interval , 0.52-1 .68 ) ( P = 0.80 , Cochran-Mantel-Haenszel ) .


The Executive Committee thus stopped the trial for futility .


Supplemental postoperative oxygen does not reduce the risk of surgical site infection rate and healing-related postoperative complications in patients having gastric bypass surgery .


To assess whether endotracheal suctioning of nonvigorous infants born through meconium stained amniotic fluid ( MSAF ) reduces the risk and complications of meconium aspiration syndrome ( MAS ) .


Term , nonvigorous babies born through MSAF were randomized to endotracheal suction and no-suction groups ( n = 61 in each ) .


Risk of MAS , complications of MAS and endotracheal suction , mortality , duration of neonatal intensive care unit stay , and neurodevelopmental outcome at 9 months were assessed .


Maternal age , consistency of meconium , mode of delivery , birth weight , sex , and Apgar scores were similar in the groups .


In total , 39 ( 32 % ) neonates developed MAS and 18 ( 14.8 % ) of them died .


There were no significant differences in MAS , its severity and complications , mortality , and neurodevelopmental outcome for the 2 groups .


One infant had a complication of endotracheal suctioning , which was mild and transient .


The current practice of routine endotracheal suctioning for nonvigorous neonates born through MSAF should be further evaluated .


Clinical Trial Registry of India : CTRI/2013/03 / 003469 .


This phase 3 trial compared the safety and efficacy of edoxaban , an oral direct factor Xa inhibitor , with enoxaparin sodium ( enoxaparin ) for thromboprophylaxis after total knee arthroplasty ( TKA ) in patients in Japan and Taiwan .


In this randomized , double-blind , double-dummy study , patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or enoxaparin 2000 IU ( equivalent to 20 mg ) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days .


The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis .


Safety endpoints included the incidence of major bleeding , clinically relevant non-major ( CRNM ) bleeding , major bleeding or CRNM bleeding , all bleeding events , adverse events , and adverse drug reactions .


Of 716 patients enrolled , 360 and 356 were randomized to receive edoxaban or enoxaparin , respectively .


The primary efficacy outcome occurred in 22/299 ( 7.4 % ) and 41/295 ( 13.9 % ) patients in the edoxaban and enoxaparin groups , respectively ( relative risk reduction = 46.8 % ) , indicating non-inferiority ( P < 0.001 ) and superiority ( P = 0.010 ) of edoxaban versus enoxaparin .


In the edoxaban and enoxaparin groups , major bleeding occurred in 4/354 ( 1.1 % ) versus 1/349 ( 0.3 % ) patients ( P = 0.373 ) ; major or CRNM bleeding occurred in 22/354 ( 6.2 % ) versus 13/349 ( 3.7 % ) patients ( P = 0.129 ) , respectively .


Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events .


Some chronic pain patients receiving long-term opioid analgesic pharmacotherapy are at risk for misusing opioids .


Like other addictive behaviors , risk of opioid misuse may be signaled by an attentional bias ( AB ) towards drug-related cues .


The purpose of this study was to examine opioid AB as a potential predictor of opioid misuse among chronic pain patients following behavioral treatment .


Chronic pain patients taking long-term opioid analgesics ( n = 47 ) completed a dot probe task designed to assess opioid AB , as well as self-report measures of opioid misuse and pain severity , and then participated in behavioral treatment .


Regression analyses examined opioid AB and cue-elicited craving as predictors of opioid misuse at 3-month posttreatment follow-up .


Patients who scored high on a measure of opioid misuse risk following treatment exhibited significantly greater opioid AB scores than patients at low risk for opioid misuse .


Opioid AB for 200 ms cues and cue-elicited craving significantly predicted opioid misuse risk 20 weeks later , even after controlling for pre-treatment opioid dependence diagnosis , opioid misuse , and pain severity ( Model R ( 2 ) = .50 ) .


Biased initial attentional orienting to prescription opioid cues and cue-elicited craving may reliably signal future opioid misuse risk following treatment .


These measures may therefore provide potential prognostic indicators of treatment outcome .


This analysis assessed changes in serum 25-hydroxyvitamin D ( 25 [ OH ] D ; the precursor form of active vitamin D ) in antiretroviral-naive adults receiving rilpivirine or efavirenz over 48 weeks in a randomized , double-blind , Phase III trial ( ECHO ) .


ECHO included 690 patients randomized 1:1 to receive rilpivirine 25 mg once daily ( n = 346 ) or efavirenz 600 mg once daily ( n = 344 ) , plus tenofovir disoproxil fumarate/emtricitabine .


25 ( OH ) D was measured in stored serum samples collected at baseline , and weeks 24 and 48 .


Proportions of patients with optimal/sufficient ( 30 ng/ml ) , insufficient ( 21-29 ng/ml ) , deficient ( 10-20 ng/ml ) and severely deficient ( < 10 ng/ml ) 25 ( OH ) D levels were determined .


Data are presented for patients with paired baseline and week 48 25 ( OH ) D data ( rilpivirine , n = 292 ; efavirenz , n = 290 ) .


After 48 weeks , mean 25 ( OH ) D levels remained largely unchanged from baseline with rilpivirine ( -0.2 ng/ml ; P = 0.57 versus no change ) , but were significantly reduced with efavirenz ( -2.5 ng/ml ; P < 0.0001 versus no change ) .


When adjusting for season of randomization and the combined variable of race ( Black/African American , White/Caucasian , Asian , other race ) and ethnicity ( Hispanic or Latino and not Hispanic or not Latino ) , the conclusion about the treatment difference between the rilpivirine and efavirenz treatment groups remained valid .


At baseline the proportion of patients with severe 25 ( OH ) D deficiency was similar in both groups ( 5 % ) but was significantly lower with rilpivirine than efavirenz at week 48 ( 5 % versus 9 % , respectively ; P = 0.032 ) .


Furthermore , of the patients with 25 ( OH ) D insufficiency/deficiency at baseline , the proportion who developed severe 25 ( OH ) D deficiency at week 48 was significantly lower with rilpivirine than efavirenz ( 2 % versus 8 % , respectively ; P = 0.0079 ) .


Rilpivirine had little effect on 25 ( OH ) D , whereas efavirenz resulted in a significant reduction in 25 ( OH ) D levels and an increase in the risk of severe 25 ( OH ) D deficiency .


This study aimed to investigate the effects of a 6-month preventive resistance training program on resting metabolic rate ( RMR ) and its associations with fat-free mass ( FFM ) and the newly described myokine irisin as two potential mechanistic links between exercise training and RMR .


In a randomized controlled trial , 74 sedentary healthy male and female participants either completed 6 months of high-repetition resistance training 3 dwk in accordance with the American College of Sports Medicine recommendations ( RT : n = 37 ; 47 7 yr ; body mass index , 25.0 3.4 kgm ) or served as controls ( CO : n = 37 ; 50 7 yr ; body mass index , 24.2 3.2 kgm ) .


Strength ( one-repetition maximum ) , RMR ( indirect calorimetry ) , body fat ( caliper method ) , and serum irisin concentration ( enzyme-linked immunosorbent assay ) were measured before and after 6 months of training .


Training led to an increase in strength ( one-repetition maximum leg press , 16 % 7 % ; P < 0.001 ) .


RMR increased in RT ( 1671 356 vs 1843 385 kcald , P < 0.001 ) but not in CO ( 1587 285 vs 1602 294 kcald , P = 0.97 ; group-time interaction , P < 0.01 ) .


Body weight ( RT , -0.5 2.4 kg ; CO , 0.1 2.3 kg ) , body fat percentage ( RT , -1.1 % 2.5 % ; CO , -0.7 % 2.9 % ) , and FFM ( RT , 0.4 2.1 kg ; CO , 0.6 1.9 kg ) did not develop differently between groups ( group-time interaction : P = 0.29 , P = 0.54 , and P = 0.59 , respectively ) .


Serum irisin concentration increased in CO ( 70.8 83.4 ngmL , P < 0.001 ) but not in RT ( 22.4 92.6 ngmL , P = 0.67 ; group-time interaction , P < 0.01 ) .


The change in RMR was not associated with the change in FFM ( r = -0.11 , P = 0.36 ) or irisin ( r = -0.004 , P = 0.97 ) .


Preventive resistance training elicits an increase in RMR .


However , in contrast to currently discussed hypotheses , this increase does not seem to be mediated by training-induced changes in FFM or circulating irisin concentration , which casts doubt in the meaning of irisin for human energy balance .


Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease , no data from comparisons with its metallic stent counterpart are available .


In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent .


Here we report secondary clinical and procedural outcomes after 1 year of follow-up .


In a single-blind , multicentre , randomised trial , we enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels .


We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold ( Absorb , Abbott Vascular , Santa Clara , CA , USA ) or treatment with an everolimus-eluting metallic stent ( Xience , Abbott Vascular , Santa Clara , CA , USA ) .


Randomisation was stratified by diabetes status and number of planned target lesions .


The co-primary endpoints of this study are vasomotion ( change in mean lumen diameter before and after nitrate administration at 3 years ) and difference between minimum lumen diameter ( after nitrate administration ) after the index procedure and at 3 years .


Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound ; composite clinical endpoints based on death , myocardial infarction , and coronary revascularisation ; device and procedural success ; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months .


Cumulative angina rate based on adverse event reporting was analysed post hoc .


This trial is registered at ClinicalTrials.gov , number NCT01425281 .


Between Nov 28 , 2011 , and June 4 , 2013 , we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group ( 335 patients , 364 lesions ) or the metallic stent group ( 166 patients , 182 lesions ) .


Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group , whereas the acute recoil post implantation was similar ( 0.19 mm for both , p = 0.85 ) .


Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography ( 1.15 mm vs 1.46 mm , p < 0.0001 ) and quantitative intravascular ultrasound ( 2.85 mm ( 2 ) vs 3.60 mm ( 2 ) , p < 0.0001 ) , resulting in a smaller lumen diameter or area post procedure .


At 1 year , however , cumulative rates of first new or worsening angina from adverse event reporting were lower ( 72 patients [ 22 % ] in the bioresorbable scaffold group vs 50 [ 30 % ] in the metallic stent group , p = 0.04 ) , whereas performance during maximum exercise and angina status by SAQ were similar .


The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups ( 16 patients [ 5 % ] vs five patients [ 3 % ] , p = 0.35 ) .


Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses ( one definite acute , one definite sub-acute , and one probable late ) , compared with no patients in the metallic stent group .


There were 17 ( 5 % ) major cardiac adverse events in the bioresorbable scaffold group compared with five ( 3 % ) events in the metallic stent group , with the most common adverse events being myocardial infarction ( 15 cases [ 4 % ] vs two cases [ 1 % ] , respectively ) and clinically indicated target-lesion revascularisation ( four cases [ 1 % ] vs three cases [ 2 % ] , respectively ) .


The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent .


Abbott Vascular .


Although sleep has been shown to enhance motor skill learning , it remains unclear whether sleep enhances learning of a functional motor task in middle-aged and older individuals .


The purpose of this study was to examine whether sleep enhances motor learning of a functional motor task in middle-aged and older adults .


Twenty middle-aged and 20 older individuals were randomly assigned to either the sleep condition or the no-sleep condition .


Participants in the sleep condition practiced a novel walking task in the evening , and returned the following morning for retesting .


Participants in the no-sleep condition practiced the walking task in the morning and returned the same day in the evening for a retest .


Outcome measures included time around the walking path and spatiotemporal gait parameters .


Only the middle-aged and older adults in the sleep condition demonstrated significant off-line improvement in performance , measured as a decline in time to walk around the novel path and improvement in spatiotemporal gait parameters .


The middle-aged and older adults in the no-sleep condition failed to demonstrate off-line improvements in performance of this functional task .


This is the first study to provide evidence that sleep facilitates learning a clinically relevant functional motor task in middle-aged and older adults .


Because many neurologic conditions occur in the middle-aged and older adults and sleep issues are very prevalent in many neurologic conditions , it is imperative that physical therapists consider sleep as a factor that may impact motor learning and recovery in these individuals .


( See Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A73 ) for more insights from the authors .


The presence of an adequate zone of keratinized tissue has been associated with implant health .


This study evaluated the increasing of the zone of keratinized tissue using dense polytetrafluoroethylene ( d-PTFE ) membranes over extraction sites , without primary closure .


Fifteen sites received d-PTFE membranes .


The control sites received no membranes .


All cases were sutured with no attempt to achieve primary closure .


Before surgery , initial measurements of buccal and lingual keratinized tissue were taken from the mucogingival line ( MGL ) to the most coronal gingival margins .


Final measurements were taken from the buccal MGL to the lingual MGL , 60 and 90 days after extractions .


In the test group , a mean increase in the zone of keratinized tissue of 7.06 2.63 mm and 6.6 2.84 mm was observed in 60 and 90 days , respectively .


In the control group , a mean increase of 2.46 1.59 mm and 1.40 1.40 mm was observed in 60 and 90 days , respectively .


Nonexpanded d-PTFE membranes can predictably be used to increase the zone of keratinized tissue in preparation to implant placement .


To investigate the impact of tuberculosis-associated immune reconstitution inflammatory syndrome ( TB-IRIS ) upon immunological recovery and the T-cell compartment after initiation of TB and antiretroviral therapy ( ART ) .


We prospectively evaluated T-cell immunophenotypes by flow cytometry and cytokines by Luminex assays in a subset ( n = 154 ) of highly immunosuppressed HIV-infected patients with TB from the Cambodian Early versus Late Introduction of Antiretrovirals randomized clinical trial .


We compared findings from patients who developed TB-IRIS with findings from patients who did not develop TB-IRIS .


Data were evaluated with mixed-effect linear regression , Kaplan-Meier estimates , and Wilcoxon rank-sum tests , and q-values were calculated to control for multiple comparisons .


Development of TB-IRIS was associated with significantly greater pre-ART frequencies of HLA-DRCD45ROCD4 , CCR5CD4 , OX40CD4 , and Fas effector memory CD8 T cells , and significantly elevated levels of plasma interleukin ( IL ) -6 , IL-1 , IL-8 , and IL-10 , and viral load .


Post-ART initiation , effector memory CD4 and Fas effector memory CD4 T-cell frequencies significantly expanded , and central memory CD4 T-cell frequencies significantly contracted in patients who experienced TB-IRIS .


By week 34 post-TB treatment initiation , effector memory/central memory CD4 T-cell ratios were markedly higher in TB-IRIS versus non-TB-IRIS patients .


A distinct pattern of pre-ART T-cell and cytokine markers appear to poise the immune response of certain patients to develop TB-IRIS .


Experience of TB-IRIS is then associated with long-term remodeling of the CD4 T-cell memory compartment towards an effector memory-dominated phenotype .


We speculate that these pre and post-ART TB-IRIS-associated immune parameters may contribute to superior immune control of TB/HIV co-infection and better clinical outcome .


Frequent handwashing can prevent infections , but non-compliance to hand hygiene is pervasive .


Few theory - and evidence-based interventions to improve regular handwashing are available .


Therefore , two intervention modules , a motivational and a self-regulatory one , were designed and evaluated .


In a longitudinal study , 205 young adults , aged 18 to 26 years , were randomized into two intervention groups .


The Mot-SelfR group received first a motivational intervention ( Mot ; risk perception and outcome expectancies ) followed by a self-regulatory intervention ( SelfR ; perceived self-efficacy and planning ) 17 days later .


The SelfR-Mot group received the same two intervention modules in the opposite order .


Follow-up data were assessed 17 and 34 days after the baseline .


Both intervention sequences led to an increase in handwashing frequency , intention , self-efficacy , and planning .


Also , overall gains were found for the self-regulatory module ( increased planning and self-efficacy levels ) and the motivational module ( intention ) .


Within groups , the self-regulatory module appeared to be more effective than the motivational module , independent of sequence .


Self-regulatory interventions can help individuals to exhibit more handwashing .


Sequencing may be important as a motivation module ( Mot ) first helps to set the goal and a self-regulatory module ( SelfR ) then helps to translate this goal into actual behavior , but further research is needed to evaluate mechanisms .


The primary goal of Phase II clinical trials is to understand better a treatment 's safety and efficacy to inform a Phase III go/no-go decision .


Many Phase II designs have been proposed , incorporating randomization , interim analyses , adaptation , and patient selection .


The Phase II design with an option for direct assignment ( i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis ( IA ) at 50 % accrual ) was recently proposed [ An et al. , 2012 ] .


We discuss this design in the context of existing designs , and extend it from a single-IA to a two-IA design .


We compared the statistical properties and clinical relevance of the direct assignment design with two IA ( DAD-2 ) versus a balanced randomized design with two IA ( BRD-2 ) and a direct assignment design with one IA ( DAD-1 ) , over a range of response rate ratios ( 2.0-3 .0 ) .


The DAD-2 has minimal loss in power ( < 2.2 % ) and minimal increase in T1ER ( < 1.6 % ) compared to a BRD-2 .


As many as 80 % more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 ( experimental vs. control ratio : 1.8 vs. 1.0 ) , and as many as 64 % more in the DAD-2 than with the DAD-1 ( 1.8 vs. 1.1 ) .


We illustrate the DAD-2 using a case study in lung cancer .


In the spectrum of Phase II designs , the direct assignment design , especially with two IA , provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients .


The success of laparoscopic surgery is due to the less surgical trauma , including less operative pain , complications and better cosmetics .


Objective of our study was to compare in two blind randomized groups of patients , the surgical outcome of total extra-peritoneal ( TEP ) inguinal hernia repair using either single-port or conventional surgical technique .


We will report our interim results in the first group of 50 patients .


Our study is a prospective , randomized , controlled clinical trial conducted from August 2011 to June 2013 .


Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups : conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair .


Clinical data on patient demographics , surgical technique and findings , postoperative complications and pain scores were collected .


Primary endpoint is the postoperative pain while secondary endpoints are recurrence , chronic pain , postoperative hospital stay and complications .


Out of the 50 patients , 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization .


Mean operative time was 51.7 ( 13.4 ) min in the multiport group and 59.3 ( 14.9 ) min in the single-port group , respectively ( P = 0.064 ) .


Mean hospital stay was 19.7 ( 4.8 ) h in the conventional group and 22.1 ( 4.5 ) h in the single-port group ( P = 0.079 ) .


No statistically significant differences were observed between the two groups for postoperative complications , and no recurrence reported at 11 months follow-up .


There was no significant difference in the pain scores ( visual analog scale ) between the two groups at regular intervals post surgery .


The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique .


Post-dural puncture headache ( PDPH ) is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia .


Since invasive treatments have known complications , pharmacologic management may be preferable .


The aim of this study was to evaluate and compare the efficacy of theophylline and Acetaminophen in treatment of PDPH .


In this single-blind randomized clinical trial , 60 patients with Class I physical status according to ASA classification system , who suffered from PDPH were enrolled .


Patients in Theophylline group were received theophylline tablet 250 mg three times per day , and in the other group acetaminophen 500 mg three times per day was administered .


Pain intensity was assessed 2 , 6 , and 12 hour after drug administration using 0-10 cm Visual Analog Scale .


The main VAS values is significantly lower in theophylline group in comparison with the acetaminophen group at 2 ( 5 + / - 1.57 vs. 5.97 + / - 1.27 ) , 6 ( 3.43 + / - 1.73 vs. 4.33 + / - 1.49 ) , and 12 ( 2.67 + / - 2.35 vs. 4.24 + / - 1.97 ) hours after drug administration ( p < 0.05 ) .


No adverse effects were reported .


Theophylline is a safe and effective treatment for PDPH .


It may be tried in PDPH patients before using any invasive technique .


Further investigations studying other Methylxanthines are recommended as well .


There is currently a lack of evidence-based therapies that are safe and effective for plaque-type morphea .


We aimed to evaluate the therapeutic potential and safety profile of imiquimod 5 % cream in plaque-type morphea .


We enrolled 25 adult patients from two Canadian centers with histologically confirmed plaque-type morphea .


Imiquimod 5 % was applied to a representative plaque , and vehicle was applied to a control plaque for 9 months .


Treatment efficacy was assessed with the Dyspigmentation , Induration , Erythema , and Telangiectasias ( DIET ) score , histology , and ultrasound evaluation .


Twenty-two patients completed the entire length of the study .


Imiquimod 5 % was superior to vehicle in reducing DIET scores at 3 , 6 , 9 , and 12 months ( p < .05 ) .


Induration demonstrated the greatest response .


Histologic evaluation showed significant improvement or resolution of disease .


However , no ultrasonographic differences were found in dermal and hypodermal thicknesses between the treatment and vehicle groups ( p > .05 ) .


Adverse effects were minimal and well tolerated .


Recent observational studies have suggested that the use of selective serotonin reuptake inhibitors is associated with an increased fracture risk and an accelerated bone loss , although conflicting results have been reported .


Furthermore , because many of these studies have been performed in depressed women , confounding by indication may influence these findings .


The objective of the study was to determine whether selective serotonin reuptake inhibitors affect bone metabolism Design : This was a randomized controlled trial .


The study was conducted in four US clinical sites .


Healthy peri - and postmenopausal women participated in the study .


The intervention was escitalopram ( 10-20 mg/d ) for the treatment of vasomotor symptoms .


Serum carboxyterminal collagen crosslinks ( CTX ) and serum amino-terminal propeptide of type I collagen ( P1NP ) were measured .


One hundred forty-one peri - or postmenopausal nondepressed women ( mean age 53.7 y , SD 4.1 ) had baseline and 8-week follow-up samples available for analysis and were included in the study ( 69 escitalopram , 72 placebo ) .


The groups were balanced across a broad range of baseline characteristics , including age , race , body mass index , smoking status , and mood symptoms .


The between-group differences in the change in CTX and P1NP from baseline to week 8 were compared by a repeated-measures linear regression model adjusted for race , clinical center , and baseline measurement .


Treatment with escitalopram reduced serum P1NP by 1.02 ng/mL on average [ 95 % confidence interval ( CI ) -5.17 , 3.12 ] compared with a reduction of 1.88 ng/mL ( 95 % CI -4.82 , 1.06 ) in the placebo group ( P = .65 ) .


Similarly , serum CTX decreased 0.02 ng/mL on average ( 95 % CI -0.05 , 0.01 ) in the escitalopram group compared with 0.00 ng/mL ( 95 % CI -0.02 , 0.02 ) in the placebo group ( P = .24 ) .


The results were similar when the analysis was restricted to those women whose adherence to study medication was 70 % or greater .


Although the study was limited to 8 weeks , these results suggest that escitalopram does not significantly alter bone metabolism in the short term .


To evaluate the longer-term safety and efficacy of secukinumab , a fully human monoclonal antiinterleukin-17A antibody , in patients with rheumatoid arthritis .


In this 52-week , double-blind , placebo-controlled ( up to Week 20 ) study ( NCT00928512 ) , patients responding inadequately to disease-modifying antirheumatic drugs ( DMARD ) or biologics were randomized to receive monthly subcutaneous injections of secukinumab ( 25 , 75 , 150 , or 300 mg ) , or placebo .


The efficacy and safety results up to Week 20 have been reported previously .


Here , efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented .


Of 237 patients randomized , 174 ( 73.4 % ) completed the study .


Patients with improved American College of Rheumatology ( ACR ) and 28-joint Disease Activity Score ( DAS28 ) C-reactive protein ( CRP ) responses at Week 16 sustained their responses through Week 52 .


In patients taking 150 mg of secukinumab , responses were improved through Week 52 ( ACR50 : Week 16 = 45 % , Week 52 = 55 % ; DAS28-CRP 2.6 : Week 16 = 25 % , Week 52 = 40 % ) .


The rate of adverse events ( AE ) from weeks 20 to 60 was 64.8 % , with most AE being mild to moderate in severity .


The overall rate of infections was 31.9 % , most being mild .


The most predominant infection was nasopharyngitis , and was not associated with dose or concurrent neutropenia .


Serious AE were reported in 21 patients ( 8.9 % ) .


There were 3 reports of malignancies ( ovarian , lung , basal cell ) , and no deaths between weeks 20 and 60 .


Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab .


The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks .


To compare the efficacy of ondansetron alone and combination of ondansetron and dexamethasone in preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .


The randomised control trial was conducted from April 23 to August 22 , 2009 , at the Liaquat National Hospital , Karachi , and comprised 100 American Society of Anaesthesiology I and II patients undergoing laparoscopic cholecystectomy .


Half of the subjects comprised Group A and received ondansetron alone , while Group B received combination of ondansetron and dexamethasone .


They were randomised by opaque envelope method .


Group A received ondansetron 4 mg while Group B received ondansetron 4 mg with dexamethasone 8 mg , 1 minute before induction .


Post-operatively patients were observed for six hours for any episode of nausea or vomiting , or whether the patients required any rescue anti emetic .


SPSS 19 was used for statistical analysis .


Patients receiving ondansetron alone showed 14 ( 28 % ) with incidence of nausea or vomiting while the other group showed 6 ( 12 % ) .


This difference was statistically significant ( p < 0.046 ) .


Combination of ondansetron and dexamethasone was more efficacious compared to ondansetron alone in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .


To explore the long-term effects of the uvulopalatopharyngoplasty ( UPPP ) combined with oral appliance ( OA ) in the treatment of obstructive sleep apnea hypopnea syndrome ( OSAHS ) .


Thirty patients with severe OSAHS confirmed by polysomnography ( PSG ) according to their apnea hypopnea index ( AHI ) and lowest SaO2 during sleep were selected using random permutation table and divided into only UPPP group ( U group , n = 15 ) and UPPP with OA group ( UA group , n = 15 ) .


The follow-up period was 2 years .


PSG was performed in 0.5 year and 2 years after operation .


AHI , lowest SaO2 and Tmax were tested and evaluated .


The effectiveness of two groups was the same after 0.5 year .


Two years after operation , the values [ AHI : ( 18.06 2.24 ) times/h ; lowest SaO2 : ( 88.64 10.37 ) % and Tmax : ( 20.5 17.6 ) s ] in UA group were better than that [ AHI : ( 49.73 3.35 ) times/h ; lowest SaO2 : ( 79.56 4.87 ) % and Tmax : ( 41.3 19.7 ) s ] in U group .


The number of effectiveness was 9 and the number of ineffectiveness was 6 in U group , while in UA group , the number of effectiveness was 14 and the number of ineffectiveness was 1 ( P < 0.05 ) .


Long-term result of combined treatment was better than that of UPPP only .


Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) .


It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG .


This study was aimed to evaluate the effects of therapist-guided ( T + ) versus self-guided ( T - ) exposure on the neural correlates of fear conditioning in PD/AG .


In a randomized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t1 ) and after CBT ( t2 ) .


Quality-controlled fMRI data from 42 patients and 42 healthy subjects ( HS ) were obtained .


Patients were randomized to two variants of CBT ( T + , n = 22 , and T - , n = 20 ) .


The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T + , T - ) , time point ( t1 , t2 ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex .


The T + group demonstrated increased activation of the hippocampus at t2 ( t2 > t1 ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t1 > t2 ) .


After T + exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG .


Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions .


Early nutrition influences metabolic programming and long-term health .


We explored the urinary metabolite profiles of 48 premature infants ( birth weight < 1500 g ) randomized to an enhanced or a standard diet during neonatal hospitalization .


Metabolomics using nuclear magnetic resonance spectroscopy ( NMR ) was conducted on urine samples obtained during the first week of life and thereafter fortnightly .


The intervention group received significantly higher amounts of energy , protein , lipids , vitamin A , arachidonic acid and docosahexaenoic acid as compared to the control group .


Enhanced nutrition did not appear to affect the urine profiles to an extent exceeding individual variation .


However , in all infants the glucogenic amino acids glycine , threonine , hydroxyproline and tyrosine increased substantially during the early postnatal period , along with metabolites of the tricarboxylic acid cycle ( succinate , oxoglutarate , fumarate and citrate ) .


The metabolite changes correlated with postmenstrual age .


Moreover , we observed elevated threonine and glycine levels in first-week urine samples of the small for gestational age ( SGA ; birth weight < 10th percentile for gestational age ) as compared to the appropriate for gestational age infants .


This first nutri-metabolomics study in premature infants demonstrates that the physiological adaptation during the fetal-postnatal transition as well as maturation influences metabolism during the breastfeeding period .


Elevated glycine and threonine levels were found in the first week urine samples of the SGA infants and emerged as potential biomarkers of an altered metabolic phenotype .


This study evaluated the efficacy and tolerability of tapentadol extended release ( ER ) for the management of chronic pain associated with diabetic peripheral neuropathy ( DPN ) .


Adults with moderate to severe DPN pain were titrated to tapentadol ER 100-250 mg bid during a 3-week open-label period ; patients with 1-point reduction in pain intensity ( 11-point numerical rating scale ) at end of titration were randomized to receive placebo or tapentadol ER ( optimal dose from titration ) for 12 weeks ( double-blind , fixed-dose maintenance phase ) .


The primary end point was mean change in average pain intensity from the start to week 12 ( last observation carried forward [ LOCF ] ) of the double-blind maintenance phase .


A total of 358 patients completed the titration period ; 318 patients ( placebo , n = 152 ; tapentadol ER , n = 166 ) were randomized and received one or more doses of double-blind study medication .


Mean ( SD ) pain intensity ( observed case ) was 7.33 ( 1.30 ) at the start and 4.16 ( 2.12 ) at week 3 of the open-label titration period ( mean [ SD ] change , -3.22 [ 1.97 ] ) .


The mean ( SD ) change in pain intensity ( LOCF ) from start of double-blind treatment to week 12 was as follows : placebo , 1.30 ( 2.43 ) ; tapentadol ER , 0.28 ( 2.04 ; least squares mean difference , -0.95 [ 95 % CI -1.42 to -0.49 ] ; P < 0.001 ) .


Treatment-emergent adverse events ( 10 % ) in the tapentadol ER group during the double-blind maintenance phase were nausea ( 21.1 % ) and vomiting ( 12.7 % ) .


Tapentadol ER ( 100-250 mg bid ) was effective and well tolerated for the management of moderate to severe chronic pain associated with DPN .


Lenvatinib , an oral inhibitor of vascular endothelial growth factor receptors 1 , 2 , and 3 , fibroblast growth factor receptors 1 through 4 , platelet-derived growth factor receptor , RET , and KIT , showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine ( iodine-131 ) .


In our phase 3 , randomized , double-blind , multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131 , we randomly assigned 261 patients to receive lenvatinib ( at a daily dose of 24 mg per day in 28-day cycles ) and 131 patients to receive placebo .


At the time of disease progression , patients in the placebo group could receive open-label lenvatinib .


The primary end point was progression-free survival .


Secondary end points included the response rate , overall survival , and safety .


The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group ( hazard ratio for progression or death , 0.21 ; 99 % confidence interval , 0.14 to 0.31 ; P < 0.001 ) .


A progression-free survival benefit associated with lenvatinib was observed in all prespecified subgroups .


The response rate was 64.8 % in the lenvatinib group ( 4 complete responses and 165 partial responses ) and 1.5 % in the placebo group ( P < 0.001 ) .


The median overall survival was not reached in either group .


Treatment-related adverse effects of any grade , which occurred in more than 40 % of patients in the lenvatinib group , were hypertension ( in 67.8 % of the patients ) , diarrhea ( in 59.4 % ) , fatigue or asthenia ( in 59.0 % ) , decreased appetite ( in 50.2 % ) , decreased weight ( in 46.4 % ) , and nausea ( in 41.0 % ) .


Discontinuations of the study drug because of adverse effects occurred in 37 patients who received lenvatinib ( 14.2 % ) and 3 patients who received placebo ( 2.3 % ) .


In the lenvatinib group , 6 of 20 deaths that occurred during the treatment period were considered to be drug-related .


Lenvatinib , as compared with placebo , was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer .


Patients who received lenvatinib had more adverse effects .


( Funded by Eisai ; SELECT ClinicalTrials.gov number , NCT01321554 . )


To investigate the effect of spa adjuvant therapy on diabetic lower extremity arterial disease ( LEAD ) .


128 patients with type II diabetes were separated into three groups according to the degree of lower extremity vascular stenosis .


Patients within each group were then randomly divided to receive no treatment ( control ) or spa adjuvant therapy ( treatment ) .


Clinical symptoms , blood pressure and hemodynamic analyses were compared between control and treatment groups by Chi square or t-test .


After adjuvant therapy with spa , patients ' pain , numbness , and cold sensation were significantly improved compared with control groups ( P < 0.05 ) .


Spa adjuvant therapy also significantly increased the dorsalis pedis pulse and systolic peak velocity ratio of patients with mild lower extremity vascular stenosis compared with control groups ( P < 0.05 ) , while there were no significant differences between the two groups for patients with moderate and severe stenosis ( P > 0.05 ) .


Both in the spa and control groups , there were no significant differences before and after medication for fasting , 2-h postprandial blood glucose and glycosylated hemoglobin ( HbA1C ) analyses ( P > 0.05 ) .


Spa adjuvant therapy can significantly alleviate lower extremity pain , numbness , and cold sensory symptoms in diabetic LEAD patients with stenosis .


Moreover , in LEAD patients with mild stenosis , spa adjuvant therapy also improves the dorsalis pedis pulse and systolic peak velocity ratio , suggesting a potential role for spa therapy as an early intervention strategy to treat the initial stages of disease .


A 12-month double-blind sham-surgery-controlled trial assessing adeno-associated virus type 2 ( AAV2 ) - neurturin injected into the putamen bilaterally failed to meet its primary endpoint , but showed positive results for the primary endpoint in the subgroup of subjects followed for 18 months and for several secondary endpoints .


Analysis of postmortem tissue suggested impaired axonal transport of neurturin from putamen to substantia nigra .


In the present study , we tested the safety and efficacy of AAV2-neurturin delivered to putamen and substantia nigra .


We performed a 15 - to 24-month , multicenter , double-blind trial in patients with advanced Parkinson disease ( PD ) who were randomly assigned to receive bilateral AAV2-neurturin injected bilaterally into the substantia nigra ( 2.0 10 ( 11 ) vector genomes ) and putamen ( 1.0 10 ( 12 ) vector genomes ) or sham surgery .


The primary endpoint was change from baseline to final visit performed at the time the last enrolled subject completed the 15-month evaluation in the motor subscore of the Unified Parkinson 's Disease Rating Scale in the practically defined off state .


Fifty-one patients were enrolled in the trial .


There was no significant difference between groups in the primary endpoint ( change from baseline : AAV2-neurturin , -7.09.92 ; sham , -5.210.01 ; p = 0.515 ) or in most secondary endpoints .


Two subjects had cerebral hemorrhages with transient symptoms .


No clinically meaningful adverse events were attributed to AAV2-neurturin .


AAV2-neurturin delivery to the putamen and substantia nigra bilaterally in PD was not superior to sham surgery .


The procedure was well tolerated , and there were no clinically significant adverse events related to AAV2-neurturin .


Suicide behaviour in psychosis is a significant clinical and social problem .


There is a dearth of evidence for psychological interventions designed to reduce suicide risk in this population .


To evaluate a novel , manualised , cognitive behavioural treatment protocol ( CBSPp ) based upon an empirically validated theoretical model .


A randomly controlled trial with independent and masked allocated and assessment of CBSPp with TAU ( n = 25 , 24 sessions ) compared to TAU alone ( n = 24 ) using standardised assessments .


Measures of suicide probability , and suicidal ideation were the primary outcomes and measures of hopelessness , depression , psychotic symptoms , functioning , and self-esteem were the secondary outcomes , assessed at 4 and 6 months follow-up .


The CBSPp group improved differentially to the TAU group on two out of three primary outcome measures of suicidal ideation and suicide probability , and on secondary outcomes of hopelessness related to suicide probability , depression , some psychotic symptoms and self-esteem .


CBSPp is a feasible intervention which has the potential to reduce proxy measures of suicide in psychotic patients .


Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes .


We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence .


This was a nonblinded , randomized , controlled , pragmatic intervention trial .


English - or Spanish-speaking patients , age 18 to 75 years , with poorly controlled type 2 diabetes , hypertension , and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care .


Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days ( of the last 7 ) on which patient took all prescribed medications .


The proportion of medications completely concordant increased in the coached group versus the usual care group ( difference in change , 10 % ; P = .05 ) .


The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group ( difference in change , 17 % ; P = .013 ) .


The mean number of adherent days increased in the coached but not in the usual care group ( difference in change , 1.08 ; P < .001 ) .


Health coaching by medical assistants significantly increases medication concordance and adherence .


The main purpose of the present investigation was to determine whether intra-alveolar chlorhexidine ( CHX ) gel is an effective preventative treatment for alveolar osteitis ( AO ) , as has been strongly suggested by previous investigators .


Another goal was to evaluate whether there is a correlation between the use of analgesics during the postoperative week and the development of AO , a correlation that could be a supplement to the commonly used diagnostic criteria for AO .


A double-blinded randomized study was performed to assess whether intra-alveolar administration of CHX decreases AO .


To achieve this objective , the extraction and postoperative course of 100 impacted mandibular third molars were studied .


Ninety-seven percent of teeth operated on had a diagnosed pathology .


The extraction alveoli were treated with CHX or placebo .


The intake of analgesics was recorded for 7 days after the operation .


Statistically important differences in AO between the control and experimental groups were not found .


The intake of analgesics reflected the occurrence of AO with a high degree of importance .


The present study did not verify that application of CHX gel improves healing after removal of impacted third molars .


The patients ' postoperative analgesic intake reflected the development of AO .


To observe the curative effect of Huqian Wan on liver and kidney-Yin deficiency knee osteoarthritis ( KOA ) .


One hundred patients were randomly divided , into a treatment ( 50 patients ) and control group ( 50 patients ) .


In the treatment group , patients orally took the Chinese medicine Huqian Wan .


Control group patients orally took Votalin , 75 mg , once a day , for 8 weeks .


The visual analog scale ( VAS ) , Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , and Medical Outcomes Study Short Form 36-Item Health Survey ( SF 36 ) were used to evaluate the curative effect before treatment and after 8 and 16 weeks of treatment .


VAS and WOMAC scores significantly decreased and SF 36 scores significantly increased after treatment in both groups compared with before treatment ( P < 0.05 ) .


There were significant differences in VAS , WOMAC , and SF 36 score changes between the two groups at week 16 ( P < 0.05 ) .


There was a significant increase in VAS and WOMAC scores in the control groups ( P < 0.05 ) between weeks 8 and 16 , but no significant difference was found in the treatment group ( P > 0.05 ) .


Huqian Wan could effectively improve the clinical symptoms and quality of life in patients with KOA .


It could also have a better and longer lasting curative effect without obvious adverse events compared with Votalin .


Highly pathogenic avian influenza A/H5N1 viruses continue to circulate in birds and infect humans causing serious illness and death .


In this randomized , observer-blinded study , adults 18 years of age ( n = 841 ) received 3.75 or 7.5 g hemagglutinin antigen ( HA ) of an AS03-adjuvanted ( AS03A or AS03B ) A/Indonesia/5 / 2005 H5N1 ( subclade 2.1 ) vaccine ( priming ) , followed by the same HA dose of AS03-adjuvanted A/turkey/Turkey / 1/05 H5N1 ( clade 2.2 ) influenza vaccine as a booster 6 or 18 months after priming ; an unprimed group received placebo at Day 0 , and 3.75 g HA of AS03A-adjuvanted booster vaccine at 6 and 18 months .


Antibody responses were assessed by hemagglutination-inhibition assay ( HI ) .


Microneutralization ( MN ) antibody and cellular immunoassays were assessed in a subset of participants .


Geometric mean titers ( GMTs ) and seroconversion rates ( SCRs ) were higher in primed vs. unprimed subjects against the booster strain 10 days following booster vaccination at month 6 and month 18 .


After the booster at 18 months , the lower limit of the 97.5 % confidence interval for the difference in SCR and GMT ratios between primed and unprimed subjects was > 15 % and > 2.0 , respectively , fulfilling the primary endpoint criteria for superiority against the booster strain .


MN and cellular immune responses corresponded with the immunogenicity seen in HI measures .


Adults primed with a dose-sparing oil-in-water adjuvanted H5N1 subclade vaccine had rapid and durable antibody responses to a heterologous subclade boosting vaccine given 6 or 18 months later .


Sodium picosulfate plus magnesium citrate ( PMC ) is a very effective , safe , and tolerated low-volume preparation for colon cleansing .


This study evaluates whether split dosing is associated with a further increase in efficacy and acceptability compared with the standard dosing regimen .


This was a multicenter , randomized , single-blind study .


Adult outpatients undergoing colonoscopy received PMC either in the standard dosing ( two sachets taken the day before endoscopy ) or in split dosing ( the second sachet taken on the morning of colonoscopy ) .


Bowel cleansing was assessed using the Boston Bowel Preparation Scale ( BBPS ) and was rated as adequate when BBPS was2 in each segment .


Patient acceptance , satisfaction , and related symptoms were recorded .


A total of 862 patients were included in the study ( 577 in the standard group and 285 in the split-dose group ) .


Preparation was adequate in only 69.8 % of patients in the standard group compared with 85.8 % of those in the split-dose group ( P = 0.0001 ) .


Mean BBPS scores for the whole colon and the right colon were also statistically significantly higher in the split-dose group ( P = 0.0001 ) .


Both regimens were well tolerated , and only 8.0 % of patients reported discomfort .


Compliance was better with the split regimen ( 0.7 % vs. 7.1 % unable to take 75 % of the preparation ; P < 0.0001 ) , and willingness to repeat the preparation was similar .


Performing colonoscopy within 6 hours after preparation was associated with better colon cleansing .


Other predictors of poor cleansing at multivariate analysis were constipation , obesity , and discomfort during preparation .


The split-dose regimen of PMC was superior to the standard regimen in terms of effective colon cleansing and compliance.ClinicalTrial.gov ( NCT01909219 ) .


Predictive low glucose management ( PLGM ) may help prevent hypoglycemia by stopping insulin pump delivery based on predicted sensor glucose values .


Hypoglycemic challenges were simulated using the Food and Drug Administration-accepted glucose simulator with 100 virtual patients .


PLGM was then tested with a system composed of a Paradigm ( ) insulin pump ( Medtronic , Northridge , CA ) , an Enlite glucose sensor ( Medtronic ) , and a BlackBerry ( ) ( Waterloo , ON , Canada ) - based controller .


Subjects ( n = 22 ) on continuous subcutaneous insulin infusion ( five females , 17 males ; median [ range ] age , 15 [ range , 14-20 ] years ; median [ range ] diabetes duration , 7 [ 2-14 ] years ; median [ range ] glycated hemoglobin , 8.0 % [ 6.7-10 .4 % ] ) exercised until the PLGM system suspended insulin delivery or until the reference blood glucose value ( HemoCue ( ) ; HemoCue GmbH , Groostheim , Germany ) reached the predictive suspension threshold setting .


PLGM reduced hypoglycemia ( < 70mg/dL ) in silico by 26.7 % compared with no insulin suspension , as opposed to a 5.3 % reduction in hypoglycemia with use of low glucose suspend ( LGS ) .


The median duration of hypoglycemia ( time spent < 70mg/dL ) with PLGM was significantly less than with LGS ( 58min vs. 101min , respectively ; P < 0.001 ) .


In the clinical trial the hypoglycemic threshold during exercise was reached in 73 % of the patients , and hypoglycemia was prevented in 80 % of the successful experiments .


The mean ( SD ) sensor glucose at predictive suspension was 927mg/dL , resulting in a postsuspension nadir ( by HemoCue ) of 7722mg/dL .


The suspension lasted for 9035 ( range , 30-120 ) min , resulting in a sensor glucose level at insulin resumption of 9719mg/dL .


In silico modeling and early feasibility data demonstrate that PLGM may further reduce the severity of hypoglycemia beyond that already established for algorithms that use a threshold-based suspension .


To improve the quality of life ( QOL ) of patients with nasopharyngeal carcinoma ( NPC ) after chemoradiotherapy ( CRT ) , it is necessary to find an effective method to reduce the toxic side-effects of CRT .


Between June 2007 and June 2010 , 83 previously untreated patients with NPC were randomized to receive CRT either with or without non-invasive extracorporeal radiofrequency ( ERF ) .


All the patients underwent radiation , and weekly chemotherapy of paclitaxel 135-175 mg/m ( 2 ) and cisplatin 60-90 mg/m ( 2 ) .


In addition , the patients in the treatment group also underwent non-invasive ERF on a radiofrequency machine at 13.56 MHz for 1 hour at 41-43C .


After the completion of treatment , evaluation was carried out to determine the survival rate , disease-free survival time , and QOL .


QOL was analyzed by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ( EORTC QLQ-C30 ) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module ( EORTC QLQ-H & N35 ) every 6 months during the three-year period .


After completion of the treatments , the 36-month survival rate was 0.730 in the treatment group and 0.535 in the reference group ( p = 0.041 ) ; the average disease-free survival time was 48 months in the treatment group and only 37.5 months in the reference group ( p = 0.048 ) .


In the post - treatment questionnaires , several NPC-specific ( pain , swallowing , speech , social eating , opening mouth , dry mouth , sticky saliva ) QOL domains were better preserved with CRT + ERF compared to CRT at different time-points .


The combination treatment of ERF with CRT can prolong the survival rate and disease-free survival time and improve the QOL for patients with NPC .


The antiproteinuric effect of a renin-angiotensin-aldosterone system blockade can be magnified by dietary salt restriction .


This study sought to determine the effect of intensive low-salt diet education on BP and urine albumin excretion in nondiabetic patients with hypertension and albuminuria .


This study was conducted between March of 2012 and March of 2013 as an open-label , randomized , controlled trial .


After a run-in period of 8 weeks , all patients received the angiotensin II receptor blocker olmesartan ( 40 mg daily ) .


Patients were then divided into two groups .


One group was treated for another 8 weeks with angiotensin II receptor blocker plus conventional low-salt diet education , and the other group was treated for 8 weeks with angiotensin II receptor blocker plus intensive low-salt diet education .


The final analyses was performed with 245 completed patients .


The amount of daily albuminuria was significantly decreased from 0 ( 566.0 [ 25.0-5398 .6 ] mg/d ) to 8 weeks ( 282.5 [ 16.1-4898 .5 ] mg/d ; P < 0.001 ) .


From 8 to 16 weeks , the 24-hour urinary sodium excretion was decreased by 36.05.9 mmol/d in the intensive education group and 8.84.9 mmol/d in the conventional education group ( interaction P < 0.001 ) .


Patients who completed intensive low-salt diet education exhibited greater decreases in urinary albumin excretion than the control group ( change in albuminuria from 8 to 16 weeks , -154.0 versus 0.4 mg/d ; P = 0.01 ) .


Urinary albumin excretion tended to decrease as the 24-hour urinary sodium excretion amount decreased ( R = 0.32 ; 95 % confidence interval , 0.20 to 0.43 ; P < 0.001 ) .


The 24-hour urinary albumin excretion was decreased more in patients in the intensive low-salt diet education group than patients in the conventional education group .


Weekly intensive education on a low-salt diet would be a suitable method for clinical practice .


This study was conducted to develop an asthma management education program for preschool children using Roy 's adaptation theory as a framework and examining the effects of this program on adaptation to asthma treatment .


A non-equivalent control group pre-post-test design was used with 43 preschool children diagnosed with asthma and required to be hospitalized for inhalation therapy .


An intervention group ( n = 23 ) participated in the educational program and a control group ( n = 20 ) received regular treatment .


The education program was conducted and evaluated from June 30 to October 31 2012 , a maximum 3 times every 24 hours during hospitalization .


Two nurses conducted the program using the teaching method of Gagne and Briggs ; instruction design theory through questionnaires to measure perception of disease , behavior of adaptation to treatment with inhalation therapy .


Effects of asthma management education program ; scores for face-pain rating decreased and time of adaptation to treatment increased significantly in the experimental group compared to the control group but no significant differences were found for perception of the disease 's cause and treatment .


Results indicate that the asthma management education program has positive effects on adaptation to asthma treatment of preschoolers .


Nutrition in the first 1,000 days of life ( during pregnancy and the first two years ) is critical for child growth and survival .


Poor maternal , infant and young child nutrition ( MIYCN ) practices are widely documented in Kenya , with potential detrimental effects on child growth and survival .


This is particularly a problem in slums , where most urban residents live .


For example , exclusive breastfeeding for the first six months is only about two per cent .


Innovative strategies to reach slum residents are therefore needed .


Strategies like the Baby Friendly Hospital Initiative have proven effective in some settings but their effectiveness in resource-limited settings , including slums where many women do not deliver in hospital , is questionable .


We propose to test the effectiveness of a home-based intervention on infant feeding practices , nutrition and health outcomes of infants born in two slums in Nairobi , Kenya .


The study , employing a cluster-randomised study design , will be conducted in two slums in Nairobi : Korogocho and Viwandani where 14 community units ( defined by the Government 's health care system ) will form the unit of randomization .


A total of 780 pregnant women and their respective child will be recruited into the study .


The mother-child pair will be followed up until the child is one year old .


Recruitment will last approximately one year and three months from September 2012 to December 2013 .


The mothers will receive regular , personalised , home-based counselling by trained Community Health Workers on MIYCN .


Regular assessment of knowledge , attitudes and practices on MIYCN will be done , coupled with assessments of nutritional status of the mother-child pairs and diarrhea morbidity for the children .


Statistical methods will include analysis of covariance and multinomial logistic regression .


Additionally , cost-effectiveness analysis will be done .


The study is funded by the Wellcome Trust and will run from March 2012 to February 2015 .


Interventions aimed at promoting optimal breastfeeding and complementary feeding practices are considered to have high impact and could prevent a fifth of the under-five deaths in countries with high mortality rates .


This study will inform policy and practice in Kenya and similar settings regarding delivery mechanisms for such high-impact interventions , particularly among urban poor populations .


ISRCTN83692672 .


Precut techniques have been used to facilitate biliary cannulation during difficult endoscopic retrograde cholangiopancreatography .


Presently , needle-knife sphincterotomy ( NKS ) is a commonly used precut technique .


Since its first description , transpancreatic sphincterotomy , as an alternative method for bile duct entry when conventional biliary cannulation failed , has been debated on its success rate of cannulation and its complications , such as increased incidence of pancreatitis .


Guidewire techniques are another effective method to improve the success rate of selective bile duct cannulation .


This is a single-center prospective randomized controlled trial aimed to compare success rate , cannulation time , and complications of guidewire-assisted transpancreatic sphincterotomy ( GATS ) and NKS for difficult biliary cannulation .


Between July 2010 and October 2013 , consecutive patients who failed in the standard biliary cannulation were randomly assigned to the GATS and NKS groups .


The outcome measures included success rate , cannulation time , and complications .


A total of 149 patients were enrolled and analyzed : 73 in the GATS group and 79 in the NKS group .


The characteristics of the 2 groups were similar .


Bile duct cannulation was successful in 70 patients ( 95.9 % ) in the GATS group and 64 ( 84.2 % ) in the NKS group ( P = 0.018 ) .


The median cannulation time spent in precut was 193 seconds in the GATS group and 485 seconds in the NKS group ( P < 0.001 ) .


There was no difference between the groups for the incidence of complications , pancreatitis , and hemorrhage ( 9.6 % vs. 10.5 % , 6.8 % vs. 6.6 % , 1.4 % vs. 3.9 % , respectively ) .


No perforation occurred .


GATS compared with NKS increases biliary cannulation rate and requires less cannulation time during difficult biliary access .


This technique is not associated with an increased risk for complications .


It seems to be an effective and safe alternative for biliary access during difficult endoscopic retrograde cholangiopancreatography .


The postprandial triglyceride-rich lipoprotein ( TRL ) concentration is a recognized independent cardiovascular disease risk factor .


Diet is the natural approach for these postprandial alterations .


Dietary polyphenols and long chain n-3 polyunsaturated fatty acids ( LCn3s ) are associated with a lower cardiovascular disease risk .


This randomized controlled study evaluated , in persons with a high risk of cardiovascular disease , the effects of diets naturally rich in polyphenols and/or marine LCn3s on plasma TRLs and urinary 8-isoprostane concentrations , a biomarker of oxidative stress .


According to a 2 2 factorial design , 86 overweight/obese individuals with a large waist circumference and any other component of the metabolic syndrome were randomly assigned to an isoenergetic diet 1 ) poor in LCn3s and polyphenols , 2 ) rich in LCn3s , 3 ) rich in polyphenols , or 4 ) rich in LCn3s and polyphenols .


The diets were similar in all other components .


Before and after the 8-wk intervention , fasting and postmeal TRLs and 8-isoprostane concentrations in 24-h urine samples were measured .


Dietary adherence was good in all participants .


Polyphenols significantly reduced fasting triglyceride concentrations ( 2-factor ANOVA ) in plasma ( P = 0.023 ) and large very-low-density lipoproteins ( VLDLs ) ( P = 0.016 ) and postprandial triglyceride total area under the curve in plasma ( P = 0.041 ) and large VLDLs ( P = 0.004 ) .


LCn3s reduced postprandial chylomicron cholesterol and VLDL apolipoprotein B-48 .


The concentrations of urinary 8-isoprostane decreased significantly with the polyphenol-rich diets .


Lipoprotein changes induced by the intervention significantly correlated with changes in 8-isoprostane .


Diets naturally rich in polyphenols positively influence fasting and postprandial TRLs and reduce oxidative stress .


Marine LCn3s reduce TRLs of exogenous origin .


Through their effects on postprandial lipemia and oxidative stress , polyphenols may favorably affect cardiovascular disease risk .


Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy .


This randomized controlled trial ( RCT ) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA .


Subjects with newly diagnosed OSA were recruited into this RCT .


The control group received usual advice on the importance of CPAP therapy and its care .


The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects ' knowledge , motivation , and self-efficacy to use CPAP through the use of a 25-min video , a 20-min patient-centered interview , and a 10-min telephone follow-up .


Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months .


CPAP usage data were downloaded at the completion of this 3-month study .


One hundred subjects with OSA ( mean SD , age 52 10 years ; Epworth Sleepiness Scales [ ESS ] , 9 5 ; median [ interquartile range ] apnea-hypopnea index , 29 [ 20 , 53 ] events/h ) prescribed CPAP treatment were recruited .


The intervention group had better CPAP use ( higher daily CPAP usage by 2 h/d [ Cohen d = 1.33 , P < .001 ] , a fourfold increase in the number using CPAP for 70 % of days with 4 h/d [ P < .001 ] ) , and greater improvements in daytime sleepiness ( ESS ) by 2.2 units ( P = .001 ) and treatment self-efficacy by 0.2 units ( P = .012 ) compared with the control group .


Subjects with OSA who received motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment , with greater improvements in treatment self-efficacy and daytime sleepiness .


ClinicalTrials.gov ; No. : NCT01173406 ; URL : www.clinicaltrials.gov .


This study aimed to observe the postoperative pain rate and degree of pain in preschool children with cleft lip and palate , and investigate the effect of nursing intervention on pain relief .


A total of 120 hospitalized cases of three - to seven-year-old preschool children with cleft lip and palate were selected from May to October 2011 .


The subjects were randomly divided into the control group and experimental groups 1 , 2 , and 3 .


The control group used conventional nursing methods , experimental group 1 used analgesic drug treatment , experimental group 2 used psychological nursing interventions , and experimental group 3 used both psychological nursing intervention and analgesic drug treatment .


After 6 , 12 , 24 , and 48 h , pain self-assessment , pain parent-assessment , and pain nurse-assessment were calculated for the four groups using the pain assessment forms , and their ratings were compared .


The postoperative pain rates of the four groups ranged from 50.0 % to 73.3 % .


The difference among the four groups was statistically significant ( P < 0.001 ) .


The differences among the control group and experimental groups 1 and 2 were not statistically significant ( P = 0.871 ) , whereas the differences among experimental group 3 and the other groups were statistically significant ( P < 0.001 ) .


Postoperative pain in preschool children with cleft lip and palate is common .


Psychological nursing intervention with analgesic treatment is effective in relieving postoperative pain .


We conducted a pilot study comparing problem solving therapy for primary care ( PST-PC ) to a dietary education control condition in middle-aged and older veterans with symptoms of emotional distress and subsyndromal depression .


This was a two-site study at the VA Pittsburgh Healthcare System and Philadelphia VA Medical Center .


Participants included veterans > 50 years of age referred from primary care clinics who were eligible if they obtained a pre-screen score > 11 on the Centers for Epidemiologic Studies Depression ( CES-D ) scale .


Exclusions were a DSM-IV Major Depressive Episode within the past year , active substance abuse/dependence within 1 month , current antidepressant therapy , and a Mini mental status exam score < 24 .


Participants were randomized to receive one of two interventions -- either PST-PC or an attention control condition consisting of dietary education ( DIET ) -- each consisting of six to eight sessions within a 4-month period .


Of 45 individuals randomized , 23 ( 11 PST-PC and 12 DIET ) completed treatment .


Using regression models in completers that examined outcomes at end of treatment while controlling for baseline scores , there were significant differences between treatment groups in SF-36 mental health component scores but not in depressive symptoms ( as assessed with either the 17-item Hamilton Rating Scale for Depression or the Beck Depression Inventory ) , social problem solving skills , or physical health status ( SF-36 physical health component score ) .


These pilot study findings suggest that a six-to-eight session version of PST-PC may lead to improvements in mental health functioning in primary care veterans with subsyndromal depressive symptoms .


To evaluate the effectiveness of Koru , a mindfulness training program for college students and other emerging adults .


Ninety students ( 66 % female , 62 % white , 71 % graduate students ) participated between Fall 2012 and Spring 2013 .


Randomized controlled trial .


It was hypothesized that Koru , compared with a wait-list control group , would reduce perceived stress and sleep problems , and increase mindfulness , self-compassion , and gratitude .


As hypothesized , results showed significant Group ( Koru , Wait-List ) Time ( Pre , Post ) interactions for improvements in perceived stress ( F [ 1 , 76.40 ] = 4.50 , p = .037 , d = .45 ) , sleep problems ( F [ 1 , 79.49 ] = 4.71 , p = .033 , d = .52 ) , mindfulness ( F [ 1 , 79.09 ] = 26.80 , p < .001 , d = 95 ) , and self-compassion ( F [ 1 , 74.77 ] = 18.08 , p < .001 , d = .75 ) .


All significant effects were replicated in the wait-list group .


Significant correlations were observed among changes in perceived stress , sleep problems , mindfulness , and self-compassion .


Results support the effectiveness of the Koru program for emerging adults in the university setting .


Past studies have shown that higher macular pigment optical density ( MPOD ) and lutein ( L ) and zeaxanthin ( Z ) supplementation are related to improvements in glare disability , photostress recovery , and chromatic contrast .


This study assessed those links using a randomized , double-blind , placebo-controlled design .


The visual effects of 1 year of supplementing L ( 10 mg/d ) and Z ( 2 mg/d ) were investigated .


One hundred fifteen young , healthy subjects were recruited and randomized into the study ( 58 received placebo , 57 L+Z ) .


Several dependent measures were collected at baseline and then once every 3 months : serum L and Z measured by HPLC chromatography ; MPOD measured using customized heterochromatic flicker photometry ; photostress recovery assessed by measuring the time needed to recover visual acquisition of a grating target after 30 seconds of an intense xenon white flash exposure ; glare disability evaluated as the energy in a surrounding annulus necessary to veil a central grating target ; and chromatic contrast assessed by measuring thresholds for a yellow grating target superposed on a 460-nm background .


Macular pigment optical density increased significantly versus placebo at all eccentricities ( 10 , 30 , 60 , and 105 minutes from the center of the macula ) .


Serum L and Z also increased significantly by the first follow-up visit ( at 3 months ) , and remained elevated throughout the intervention period of 1 year .


Chromatic contrast and photostress recovery time improved significantly versus placebo .


Glare disability was correlated with macular pigment density throughout the study period but did not increase significantly in the treated group .


Daily supplementation with L+Z resulted in significant increase in serum levels and MPOD and improvements in chromatic contrast and recovery from photostress .


These results are consistent with past studies showing that increasing MPOD leads to improved visual performance .


( ClinicalTrials.gov number , NCT00909090 . )


Combination therapy may help high-risk patients achieve low-density lipoprotein cholesterol ( LDL-C ) goals .


Impact of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg ( RSV10/EZE10 and RSV20/EZE10 ) has not been fully characterized previously .


GRAVITY ( NCT00525824 ) compared efficacy , safety and effect on biomarkers of RSV10/EZE10 and RSV20/EZE10 vs. simvastatin 40 mg and 80 mg plus EZE10 ( SIM40/EZE10 and SIM80/EZE10 ) in patients with coronary heart disease ( CHD ) or CHD risk equivalent .


Adult patients ( n = 833 ) were randomized to RSV10/EZE10 , RSV20/EZE10 , SIM40/EZE10 or SIM80/EZE10 .


Following a 6-week dietary lead-in , patients received 6 weeks ' statin monotherapy followed by same statin dose plus ezetimibe for 6 more weeks .


Primary endpoint was LDL-C change from baseline to 12 weeks .


Significantly greater ( p < 0.05 ) reductions in LDL-C and other atherogenic lipids were observed with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10 .


A significantly greater proportion of patients achieved LDL-C goals of < 100 mg/dl and < 70 mg/dl with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10 .


LDL-C was reduced 10-14 % further with combination therapy vs. monotherapy .


Statin monotherapy reduced cholesterol and bile acid synthesis biomarkers , ezetimibe reduced - sitosterol ( sterol absorption marker ) , and combination therapy achieved additive reductions in lipoprotein-associated phospholipase A2 mass and activity , free cholesterol and 7-ketocholesterol .


Safety profiles of rosuvastatin/ezetimibe and simvastatin/ezetimibe combinations were comparable .


Co-administration of rosuvastatin 10 or 20 mg plus ezetimibe achieved significant improvements in lipid profiles in high-risk patients vs. simvastatin 40 or 80 mg plus ezetimibe .


Micronutrient deficiencies occur early in human immunodeficiency virus ( HIV ) infection , and supplementation with micronutrients may be beneficial ; however , its effectiveness has not been investigated early in HIV disease among adults who are antiretroviral therapy ( ART ) naive .


To investigate whether long-term micronutrient supplementation is effective and safe in delaying disease progression when implemented early in adults infected with HIV subtype C who are ART-naive .


Randomized clinical trial of supplementation with either daily multivitamins ( B vitamins and vitamins C and E ) , selenium alone , or multivitamins with selenium vs placebo in a factorial design for 24 months .


The study was conducted in 878 patients infected with HIV subtype C with a CD4 cell count greater than 350/L who were not receiving ART at Princess Marina Hospital in Gaborone , Botswana , between December 2004 and July 2009 .


Daily oral supplements of B vitamins and vitamins C and E , selenium alone , or multivitamins plus selenium , compared with placebo .


Reaching a CD4 cell count less than 200/L until May 2008 ; after this date , reaching a CD4 cell count of 250/L or less , consistent with the standard of care in Botswana for initiation of ART at the time of the study .


There were 878 participants enrolled and randomized into the study .


All participants were ART-naive throughout the study .


In intent-to-treat analysis , participants receiving the combined supplement of multivitamins plus selenium had a significantly lower risk vs placebo of reaching CD4 cell count 250/L or less ( adjusted hazard ratio [ HR ] , 0.46 ; 95 % CI , 0.25-0 .85 ; P = .01 ; absolute event rate [ AER ] , 4.79 / 100 person-years ; censoring rate , 0.92 ; 17 events ; placebo AER , 9.22 / 100 person-years ; censoring rate , 0.85 ; 32 events ) .


Multivitamins plus selenium in a single supplement , vs placebo , also reduced the risk of secondary events of combined outcomes for disease progression ( CD4 cell count 250/L , AIDS-defining conditions , or AIDS-related death , whichever occurred earlier [ adjusted HR , 0.56 ; 95 % CI , 0.33-0 .95 ; P = .03 ; AER , 6.48 / 100 person-years ; censoring rate , 0.90 ; 23 events ] ) .


There was no effect of supplementation on HIV viral load .


Multivitamins alone and selenium supplementation alone were not statistically different from placebo for any end point .


Reported adverse events were adjudicated as unlikely to be related to the intervention , and there were no notable differences in incidence of HIV-related and health-related events among study groups .


In ART-naive HIV-infected adults , 24-month supplementation with a single supplement containing multivitamins and selenium was safe and significantly reduced the risk of immune decline and morbidity .


Micronutrient supplementation may be effective when started in the early stages of HIV disease .


The production of high quality systematic reviews requires rigorous methods that are time-consuming and resource intensive .


Citation screening is a key step in the systematic review process .


An opportunity to improve the efficiency of systematic review production involves the use of non-expert groups and new technologies for citation screening .


We performed a pilot study of citation screening by medical students using four screening methods and compared students ' performance to experienced review authors .


The aims of this pilot randomised controlled trial were to provide preliminary data on the accuracy of title and abstract screening by medical students , and on the effect of screening modality on screening accuracy and efficiency .


Medical students were randomly allocated to title and abstract screening using one of the four modalities and required to screen 650 citations from a single systematic review update .


The four screening modalities were a reference management software program ( EndNote ) , Paper , a web-based systematic review workflow platform ( ReGroup ) and a mobile screening application ( Screen2Go ) .


Screening sensitivity and specificity were analysed in a complete case analysis using a chi-squared test and Kruskal-Wallis rank sum test according to screening modality and compared to a final set of included citations selected by expert review authors .


Sensitivity of medical students ' screening decisions ranged from 46.7 % to 66.7 % , with students using the web-based platform performing significantly better than the paper-based group .


Specificity ranged from 93.2 % to 97.4 % with the lowest specificity seen with the web-based platform .


There was no significant difference in performance between the other three modalities .


Medical students are a feasible population to engage in citation screening .


Future studies should investigate the effect of incentive systems , training and support and analytical methods on screening performance .


Cochrane Database CD001048 .


To evaluate the clinical effect of Traditional Chinese Spinal Orthopedic Manipulation ( TCSOM ) in treating Irritable Bowel Syndrome ( IBS ) in comparison with Pinaverium Bromide Dicetel ( PBD ) , and to assess a possible cause for IBS .


60 cases of IBS patients were randomly divided into two groups : TCSOM and PBD .


All patients in the TCSOM group were treated with a 5-time spinal manipulations .


The symptoms of pre-treatment and post-treatment were evaluated based on bowel symptom scale ( BSS ) scores .


A symptom improvement rating ( SIR ) and patient subjective assessment ( PSA ) were implemented in order to evaluate the effects of the treatments , and to statistically compare the two groups .


The symptoms of 23 patients of the TCSOM group disappeared soon after spinal manipulation and 6 cases were significantly improved .


The BSS scores in the TCSOM group were significantly lower than those in the PBD group post-treatment .


According to the SIR which was based on the BSS , the TCSOM research group included 14 cases with excellent results , 13 cases with good , and 3 cases with poor .


Adverse side effects to the treatment were not reported .


Based on the BSS , the PBD research group reported 7 cases with excellent results , 8 cases with good and 15 cases with poor .


All cases were statistically analyzed , revealing a significant difference ( P < 0.001 ) between the two groups .


The displacement of inter-vertebral disks and/or vertebra in the thoracic or lumbar region seems to be a contributing factor in the symptoms of irritable bowel syndrome .


Thumb pressing manipulation on jiaji points in the thoracic and/or lumbar region can correct the displacement of inter-vertebral disks and/or vertebra , resolving the stimuli caused by pressure exerted on the nerves and vessels around the spine .


So it is an effective treatment for IBS .


Major depressive disorder ( MDD ) is associated with decreased physical activity and increased rates of the metabolic syndrome ( MetS ) , a risk factor for the development of type 2 diabetes and cardiovascular disorders .


Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors .


Therefore , our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors .


Fourty-two inpatients with moderate to severe depression were included .


Twenty-two patients were randomized to additional 3x weekly exercise training ( EXERCISE ) and compared to treatment as usual ( TAU ) .


Exercise capacity was assessed as peak oxygen uptake ( VO2peak ) , ventilatory anaerobic threshold ( VAT ) and workload expressed as Watts ( W ) .


Metabolic syndrome was defined according to NCEP ATPIII panel criteria .


After 6 weeks of treatment , cardiorespiratory fitness ( VO2peak , VAT , Watt ) , waist circumference and HDL cholesterol were significantly improved in EXERCISE participants .


Treatment response expressed as 50 % MADRS reduction was more frequent in the EXERCISE group .


Adjunctive exercise training in depressed inpatients improves physical fitness , MetS factors , and psychological outcome .


Given the association of depression with cardiometablic disorders , exercise training is recommended as an adjunct to standard antidepressant treatment .


Ten-valent pneumococcal conjugate vaccine ( PCV10 ) was earlier shown to reduce clinically suspected , non-laboratory-confirmed invasive pneumococcal disease ( IPD ) in a cluster-randomized trial ( the Finnish Invasive Pneumococcal disease trial ) .


PCV10 was introduced into the Finnish national vaccination program in September 2010 using a 3-dose schedule .


We evaluated the impact of PCV10 on clinically suspected IPD among vaccine-eligible children in a population-based nationwide study .


The target cohort eligible for vaccination program ( children born June 2010-September 2013 ) was compared with 2 season - and age-matched ( ages 3-42 months ) reference cohorts before PCV10 introduction .


The trial period ( January 2009-August 2010 ) was excluded .


Hospitals ' inpatient and outpatient discharge notifications with International Classification of Diseases , 10th Revision , diagnoses compatible with IPD ( A40 .3 / B95 .3 / G00 .1 / M00 .1 ) and unspecified sepsis ( A40 .9 / A41 .9 / A49 .9 / G00/G00 .9 / I30 .1 / M00/M00 .9 / B95 .5 ) were collected from the national Care Register .


Laboratory-confirmed IPD cases were excluded .


Rates of register-based non-laboratory-confirmed IPD ( or unspecified sepsis ) before and after PCV10 implementation were calculated .


The rate of register-based non-laboratory-confirmed IPD episodes was 32 in 100000 person-years in the vaccine-eligible target cohort and 94 in the combined reference cohorts .


Relative rate reduction was 66 % ( 95 % confidence interval : 59-73 ) and absolute rate reduction 62 in 100000 person-years .


For the more sensitive case definition of register-based non-laboratory-confirmed IPD or unspecified sepsis , the relative rate reduction was 34 % ( 95 % confidence interval 29-39 ) , but the absolute reduction was as high as 122 in 100000 person-years .


This is the first report demonstrating nationwide PCV impact on clinically suspected IPD during routine vaccination program .


The large absolute rate reductions observed have major implications for cost-effectiveness of PCVs .


The authors analyzed a preliminary report of patient-reported outcomes ( PROs ) among men who received high-dose radiation therapy ( RT ) on Radiation Therapy Oncology Group study 0126 ( a phase 3 dose-escalation trial ) with either 3-dimensional conformal RT ( 3D-CRT ) or intensity-modulated RT ( IMRT ) .


Patients in the 3D-CRT group received 55.8 gray ( Gy ) to the prostate and proximal seminal vesicles and were allowed an optional field reduction ; then , they received 23.4 Gy to the prostate only .


Patients in the IMRT group received 79.2 Gy to the prostate and proximal seminal vesicles .


PROs were assessed at 0 months ( baseline ) , 3 months , 6 months , 12 months , and 24 months and included bladder and bowel function assessed with the Functional Alterations due to Changes in Elimination ( FACE ) instrument and erectile function assessed with the International Index of Erectile Function ( IIEF ) .


Analyses included the patients who completed all data at baseline and for at least 1 follow-up assessment , and the results were compared with an imputed data set .


Of 763 patients who were randomized to the 79.2-Gy arm , 551 patients and 595 patients who responded to the FACE instrument and 505 patients and 577 patients who responded to the IIEF were included in the completed and imputed analyses , respectively .


There were no significant differences between modalities for any of the FACE or IIEF subscale scores or total scores at any time point for either the completed data set or the imputed data set .


Despite significant reductions in dose and volume to normal structures using IMRT , this robust analysis of 3D-CRT and IMRT demonstrated no difference in patient-reported bowel , bladder , or sexual functions for similar doses delivered to the prostate and proximal seminal vesicles with IMRT compared with 3D-CRT delivered either to the prostate and proximal seminal vesicles or to the prostate alone .


Extensive coronary artery disease ( CAD ) is associated with higher risk .


In this substudy of the PLATO trial , we examined the effects of randomized treatment on outcome events and safety in relation to the extent of CAD .


Patients were classified according to presence of extensive CAD ( defined as 3-vessel disease , left main disease , or prior coronary artery bypass graft surgery ) .


The trial 's primary and secondary end points were compared using Cox proportional hazards regression .


Among 15,388 study patients for whom the extent of CAD was known , 4,646 ( 30 % ) had extensive CAD .


Patients with extensive CAD had more high-risk characteristics and experienced more clinical events during follow-up .


They were less likely to undergo percutaneous coronary intervention ( 58 % vs 79 % , P < .001 ) but more likely to undergo coronary artery bypass graft surgery ( 16 % vs 2 % , P < .001 ) .


Ticagrelor , compared with clopidogrel , reduced the composite of cardiovascular death , myocardial infarction , and stroke in patients with extensive CAD ( 14.9 % vs 17.6 % , hazard ratio [ HR ] 0.85 [ 0.73-0 .98 ] ) similar to its reduction in those without extensive CAD ( 6.8 % vs 8.0 % , HR 0.85 [ 0.74-0 .98 ] , Pinteraction = .99 ) .


Major bleeding was similar with ticagrelor vs clopidogrel among patients with ( 25.7 % vs 25.5 % , HR 1.02 [ 0.90-1 .15 ] ) and without ( 7.3 % vs 6.4 % , HR 1.14 [ 0.98-1 .33 ] , Pinteraction = .24 ) extensive CAD .


Patients with extensive CAD have higher rates of recurrent cardiovascular events and bleeding .


Ticagrelor reduced ischemic events to a similar extent both in patients with and without extensive CAD , with bleeding rates similar to clopidogrel .


The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus ( HCV ) infections require further evaluation and comparison with those of interferon-containing regimens .


We compared a regimen of peginterferon , ribavirin , and sofosbuvir with a regimen of simeprevir and sofosbuvir in patients with HCV infection and unfavorable treatment features .


We performed a prospective open-label study of 82 patients with chronic HCV genotype 1a infection and Child 's grade A cirrhosis enrolled from 2 clinics at a single center in Atlanta , Georgia , from December 2013 through January 2014 .


Fifty patients ( 61 % ) had not responded to treatment with peginterferon and ribavirin ( null responders ) , and 32 ( 39 % ) were therapy naive ; 39 ( 48 % ) were African American .


Subjects were assigned randomly to groups given simeprevir ( 150 mg/day ) and sofosbuvir ( 400 mg/day ) ( n = 58 in the final analysis ) or peginterferon alfa 2b ( 1.5 mcg/kg/wk ) , ribavirin ( 1000-1200 mg/day ) , and sofosbuvir ( 400 mg/day ) ( n = 24 in the final analysis ) .


Both regimens were given for 12 weeks .


The primary trial end point was the proportion of patients with undetectable HCV-RNA levels 12 weeks after therapy completion ( SVR12 ) .


A significantly greater percentage of patients ( 93 % ) given simeprevir and sofosbuvir achieved an SVR12 than those given the interferon-containing regimen ( 75 % ) ( P = .02 ) .


Patients given the interferon-containing regimen had a significantly higher rate of virologic relapse than patients given simeprevir and sofosbuvir ( P = .009 ) , as well as worse self-reported outcomes and more side effects .


Quality-of-life scores were higher in patients with SVR12 than those without , regardless of treatment regimen .


In a prospective study of patients with chronic HCV genotype 1a infection and cirrhosis ( 48 % African American and 61 % prior null responders ) , a 12-week regimen of simeprevir and sofosbuvir produced a significantly higher rate of SVR12 and was better tolerated , with a lower viral relapse rate , than a 12-week regimen of peginterferon , ribavirin , and sofosbuvir .