Participants were recruited when receiving their first CD4 results at the clinic .


All reported unprotected sex in the previous 3 months .


Logistic regression identified predictors of pregnancy intent for the total sample and by gender .


About three fifths of men and one fifth of women reported intent to conceive in the next 6 months .


In the full-sample multiple regression analysis , men [ adjusted odds ratio ( AOR = 6.62 ) ] and those whose main partner shared intent to conceive ( AOR = 3.80 ) had significantly higher odds of pregnancy intent ; those with more years of education ( AOR = 0.81 ) and more biological children ( AOR = 0.62 ) had lower odds of intending pregnancy .


In gender-specific analyses , partner sharing pregnancy intent was positively associated with intent among both men ( AOR = 3.53 ) and women ( AOR = 13.24 ) .


Among men , odds were lower among those having more biological children ( AOR = 0.71 ) and those unemployed ( AOR = 0.30 ) .


Among women , relying on hormonal contraception was negatively associated with intent ( AOR = 0.08 ) , and main partner knowing her HIV status ( AOR = 5.80 ) was positively associated with intent to conceive .


Findings underscore the importance of providing integrated SRH services , and we discuss implications for clinical practice and care .


To compare posterior capsule opacification ( PCO ) of a hydrophobic acrylic heparin surface modified intraocular lens ( HSM-IOL ) and an uncoated IOL ( UC-IOL ) 1 year after implantation .


One hundred two eyes of 51 patients underwent routine phacoemulsification with randomized implantation of a HSM-IOL in one eye ( the HSM-IOL group ) and a UC-IOL in the fellow eye ( the UC-IOL group ) .


Morphologic PCO evaluation was performed comparing digital photographs in retroillumination using the Evaluation of Posterior Capsule Opacification ( EPCO ) system , grading the density of the opacification from 0 to 4 ( 0 = none , 1 = minimal , 2 = mild , 3 = moderate , and 4 = severe ) .


Distance visual acuities , subjective manifest refraction , pupil size , straylight measurements , flare in the anterior chamber using a laser flare meter , and contrast sensitivity were also evaluated .


The mean total EPCO score was slightly higher in the HSM-IOL group ( 0.50 0.45 ) compared to the UC-IOL group ( 0.45 0.46 ) , but did not reach statistical significance .


No statistically significant differences were found in the other main outcome parameters ( straylight measurement , distance visual acuities , flare in the anterior chamber , and mesopic and photopic contrast sensitivity ) when comparing both IOLs .


Although the HSM-IOL showed decreased flare 1 day postoperatively , no statistically significant differences regarding PCO were found 1 year postoperatively .


Unsupervised segmentation of multi-spectral images plays an important role in annotating infrared microscopic images and is an essential step in label-free spectral histopathology .


In this context , diverse clustering approaches have been utilized and evaluated in order to achieve segmentations of Fourier Transform Infrared ( FT-IR ) microscopic images that agree with histopathological characterization .


We introduce so-called interactive similarity maps as an alternative annotation strategy for annotating infrared microscopic images .


We demonstrate that segmentations obtained from interactive similarity maps lead to similarly accurate segmentations as segmentations obtained from conventionally used hierarchical clustering approaches .


In order to perform this comparison on quantitative grounds , we provide a scheme that allows to identify non-horizontal cuts in dendrograms .


This yields a validation scheme for hierarchical clustering approaches commonly used in infrared microscopy .


We demonstrate that interactive similarity maps may identify more accurate segmentations than hierarchical clustering based approaches , and thus are a viable and due to their interactive nature attractive alternative to hierarchical clustering .


Our validation scheme furthermore shows that performance of hierarchical two-means is comparable to the traditionally used Ward 's clustering .


As the former is much more efficient in time and memory , our results suggest another less resource demanding alternative for annotating large spectral images .


Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals .


We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction .


We conducted a pilot randomized controlled trial ( RCT ) where participants were randomly assigned to the intervention with routine education or routine education alone .


The outcomes evaluated were decisional conflict , decision self-efficacy , satisfaction with information , perceived involvement in care , and uptake of reconstruction following surgical consultation .


Trial feasibility and acceptability were evaluated , and effect sizes were calculated to determine the primary outcome for the full-scale RCT .


Of the 41 patients enrolled , recruitment rate was 72 % , treatment fidelity was 98 % , and retention rate was 95 % .


The Cohen 's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education ( 0.69 , 95 % CI = 0.02-1 .42 ) , while the effect sizes of increase in decision self-efficacy ( 0.05 , 95 % CI = -0.60 -0.71 ) and satisfaction with information ( 0.11 , 95 % CI = -0.53 -0.76 ) were small .


A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction ( 14/20 or 70 % ) compared to the intervention group ( 8/21 or 38 % ) P = 0.06 .


A pre-consultation educational group intervention improves patients ' shared decision-making quality compared to routine preoperative patient education .


A full-scale definitive RCT is warranted based on high feasibility outcomes , and the primary outcome for the main trial will be decisional conflict .


The incremental prognostic value of admission measurements of biomarkers beyond clinical characteristics and extent of coronary artery disease ( CAD ) in patients treated with primary percutaneous coronary intervention ( PPCI ) for ST-elevation myocardial infarction ( STEMI ) is unclear .


Centrally analyzed plasma for biomarker measurements was available in 5,385 of the STEMI patients treated with PPCI in the PLATO trial .


Extent of CAD was graded by operators in association with PPCI .


We evaluated the prognostic value of high-sensitivity cardiac troponin T , N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) , and growth differentiation factor 15 ( GDF-15 ) beyond clinical characteristics and extent of CAD using Cox proportional hazards analyses , C-index , and net reclassification improvement ( NRI ) .


Outcomes were cardiovascular death ( CVD ) and spontaneous myocardial infarction ( MI ) .


Angiographic data on extent of CAD improved the prediction of CVD compared to clinical risk factors alone , increasing the C-index from 0.760 to 0.778 , total NRI of 0.31 .


Biomarker information provided additional prognostic value for CVD beyond clinical risk factors and extent of CAD , C-indices ranging from 0.792 to 0.795 for all biomarkers , but with a higher NRI for NT-proBNP .


Extent of CAD and high-sensitivity cardiac troponin T were not associated with spontaneous MI .


The prediction of spontaneous MI beyond clinical characteristics and extent of CAD ( C-index 0.647 ) was improved by both NT-proBNP ( C-index 0.663 , NRI 0.22 ) and GDF-15 ( C-index 0.652 , NRI 0.05 ) .


Biomarker measurement on admission is feasible and provides incremental risk stratification in patients with STEMI treated with PPCI , with NT-proBNP and GDF-15 being most valuable due to the association with both CVD and spontaneous MI .


Use of the patient 's body surface area ( mg m ( -2 ) ) as a basis for dosing does not take individual variation in metabolic capacity and rate of clearance into account .


Here , we evaluated a novel approach for individual monitoring of short-lived cytotoxic agents formed from cytostatic drugs such as cyclophosphamide ( CP ) .


The accumulated blood dose of the cytotoxic active agent phosphoramide mustard ( PAM ) formed from CP was measured as a reaction product with hemoglobin ( Hb adduct ) .


This adduct , N - [ 2 - ( 2-oxazolidonyl ) ethyl ] - valyl Hb ( OzVal-Hb ) , was detached from Hb with the adduct FIRE procedure , and the formed analyte was quantified using LC-MS/MS .


This dose biomarker for PAM and the analytical procedure was evaluated in accordance with the guidelines on bioanalytical method validation formulated by the European Medicine Agency .


The evaluated method was applied to quantify blood dose levels of PAM in female breast cancer patients ( n = 12 ) before and after three cycles of polychemotherapy regimes containing CP .


OzVal-Hb , a specific and stable biomarker , could be measured with great sensitivity ( lower limit of quantification = 33 pmol g ( -1 ) Hb ) , high accuracy ( within 20 % ) and good repeatability ( CV < 20 % ) .


The inter-individual variability in the blood level of this adduct in women with breast cancer ( n = 12 ) who received three doses of CP in combination with one or two other cytostatic drugs was 250 % following the first dose and approximately 150 % after each subsequent dose .


Measurement of the biomarker OzVal-Hb can be used to quantify the short-lived cytotoxic agent PAM in a single blood sample drawn several days after therapy .


This procedure may aid in individualizing doses of CP , thereby improving efficacy while both reducing the risk of and increasing the predictability of side-effects .


The objective of this study was to evaluate the effect of platelet-rich plasma ( PRP ) , platelet-rich fibrin ( PRF ) , and concentrated growth factor ( CGF ) on bone healing .


Twelve rabbits were included in this randomized , blinded , prospective study .


15-mm10-mm-sized defects were created in the parietal bone , filled with PRP , PRF , CGF , and void .


The bone mineral density and bone volume were analyzed with microscopic computed tomography ( micro-CT ) and histomorphometrics at the 6th and 12th week .


In micro-CT analysis , bone mineral density and bone volume were greater in the experimental group than in controls at both 6th and 12th week , but not among the experimental groups .


Similarly , histomorphometric examination revealed that more bone formation was seen in the experimental group .


The addition of PRP , PRF , and CGF had significantly increased bone formation at the 6th week .


The effect of PRP , PRF , and CGF was similar and may be useful in the future to increase the success rate of bone grafting .


To evaluate the short-term efficacy and long-term preventive effect on recurrence in prevention and treatment of children allergic rhinitis treated with the multiple therapy at Dazhui ( GV 14 ) as the main acupoint and acupoint plaster therapy .


One hundred and twenty cases of children allergic rhinitis were randomized into a triple-strong stimulation therapy group and an acupoint plaster therapy group , 60 cases in each one .


In the triple-strong stimulation therapy group , Dazhui ( GV 14 ) was the main acupoint , combined with one of Feishu ( BL 13 ) , Zhiyang ( GV 9 ) and Shenshu ( BL 23 ) accordingly .


The heavy needling technique was adopted with the three-edged needle , followed by heavy cupping and heavy moxibustion .


The treatment was given once every 3 days , continuously for 10 times .


In the acupoint plaster therapy group , the acupoints selected were same as the triple-strong stimulation therapy group .


The self-prepared Chinese herbal plaster was used , 4 h to 8 h each one time , once every 3 days , continuously for 10 times .


The changes in the symptom and physical sign scores were observed before treatment , after treatment and in 6 months follow-up visit after treatment in the two groups .


The clinical efficacy was compared between the two groups .


After treatment and in 6 months follow-up visit after treatment , the symptom scores , physical sign scores and symptom scores of each item were different signi ficantly as compared with those before treatment in the triple-strong stimulation therapy group ( P < 0.01 , P < 0.05 ) , and the results in the triple-strong stimulation therapy group were better than those in the acupoint plaster therapy group ( all P < 0.01 ) .


In 6 months follow-up visit , the total effective rate was 94.6 % ( 53/56 ) in the triple-strong stimulation therapy group and was 25.9 % ( 15/58 ) in the acupoint plaster therapy group , indicating the significant difference ( P < 0.001 ) .


The triple-strong stimulation therapy at Dazhui ( GV 14 ) achieves the superior effect on the prevention and treatment of children allergic rhinitis as compared with the acupoint plas ter therapy and has good long-term effect of the prevention from recurrence .


Postoperative pain is an important health-care issue .


Patient-controlled analgesia ( PCA ) is considered the gold standard for systemic postoperative pain treatment .


Methadone PCA is used for patients with chronic pain and those in the palliative care setting .


However , its efficacy as a first-line drug for acute postoperative pain is unknown .


This study evaluated the use of postoperative methadone PCA after total hip arthroplasty ( THA ) compared with morphine PCA .


This was a randomized , double-blind , controlled , parallel-group study .


Patients were randomized into two groups : group methadone -- methadone PCA , and group morphine -- morphine PCA , for postoperative analgesia .


Drugs were delivered through PCA pumps throughout the first 24 h after surgery ( T1 :6 , T2 :12 , T3 :18 , T4 :24 h ) .


Opioid consumption in 24 h was significantly lower for group methadone than for group morphine .


Group methadone patients experienced significantly less pain than group morphine at rest .


Pain after movement was significantly lower in group methadone at T1 and T3 and marginally lower at T2 and T4 .


Adverse events more frequently reported were sleepiness , nausea , and vomiting , but no statistical difference between groups was found .


This study demonstrated that methadone PCA prompted less opioid consumption and lower pain scores at rest and at motion in comparison with morphine PCA as postoperative analgesia after THA .


The anti-EGFR monoclonal antibodies panitumumab and cetuximab are effective in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer .


We assessed the efficacy and toxicity of panitumumab versus cetuximab in these patients .


For this randomised , open-label , phase 3 head-to-head study , we enrolled patients ( from centres in North America , South America , Europe , Asia , Africa , and Australia ) aged 18 years or older with chemotherapy-refractory metastatic colorectal cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 2 or less , and wild-type KRAS exon 2 status .


Using a computer-generated randomisation sequence , we assigned patients ( 1:1 ; stratified by geographical region and ECOG performance status , with a permuted block method ) to receive panitumumab ( 6 mg/kg once every 2 weeks ) or cetuximab ( initial dose 400 mg/m ( 2 ) ; 250 mg/m ( 2 ) once a week thereafter ) .


The primary endpoint was overall survival assessed for non-inferiority ( retention of 50 % of the cetuximab treatment effect ; historical hazard ratio [ HR ] for cetuximab plus best supportive care vs best supportive care alone of 0.55 ) .


The primary analysis included patients who received one or more dose of panitumumab or cetuximab , analysed per allocated treatment .


Recruitment for this trial is closed .


The trial is registered with ClinicalTrials.gov , number NCT01001377 .


Between Feb 2 , 2010 , and July 19 , 2012 , we enrolled and randomly allocated 1010 patients , 999 of whom began study treatment : 499 received panitumumab and 500 received cetuximab .


For the primary analysis of overall survival , panitumumab was non-inferior to cetuximab ( Z score -3.19 ; p = 0.0007 ) .


Median overall survival was 10.4 months ( 95 % CI 9.4-11 .6 ) with panitumumab and 10.0 months ( 9.3-11 .0 ) with cetuximab ( HR 0.97 ; 95 % CI 0.84-1 .11 ) .


Panitumumab retained 105.7 % ( 81.9-129 .5 ) of the effect of cetuximab on overall survival seen in this study .


The incidence of adverse events of any grade and grade 3-4 was similar across treatment groups .


Grade 3-4 skin toxicity occurred in 62 ( 13 % ) patients given panitumumab and 48 ( 10 % ) patients given cetuximab .


The occurrence of grade 3-4 infusion reactions was lower with panitumumab than with cetuximab ( one [ < 0.5 % ] patient vs nine [ 2 % ] patients ) , and the occurrence of grade 3-4 hypomagnesaemia was higher in the panitumumab group ( 35 [ 7 % ] vs 13 [ 3 % ] ) .


We recorded one treatment-related fatal adverse event : a lung infection in a patient given cetuximab .


Our findings show that panitumumab is non-inferior to cetuximab and that these agents provide similar overall survival benefit in this population of patients .


Both agents had toxicity profiles that were to be expected .


In view of the consistency in efficacy and toxicity seen , small but meaningful differences in the rate of grade 3-4 infusion reactions and differences in dose scheduling can guide physician choice of anti-EGFR treatment .


The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine ( CHX 0.2 % ) and distilled water as control ( placebo ) .


A double-blind randomised control trial was conducted among undergraduate students who volunteered .


They were randomly allocated into three study groups : 1 ) Terminalia chebula mouthwash ( n = 30 ) ; 2 ) chlorhexidine ( active control ) ( n = 30 ) ; 3 ) distilled water ( placebo ) ( n = 30 ) .


Assessment was carried out according to plaque score and gingival score .


Statistical analysis was carried out to compare the effect of both mouthwashes .


ANOVA and post-hoc LSD tests were performed using SPSS version 17 with p 0.05 considered statistically significant .


Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation .


The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to the placebo .


The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash .


Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter .


Celiac disease ( CeD ) is a prevalent autoimmune condition .


Recurrent signs and symptoms are common despite treatment with a gluten-free diet ( GFD ) , yet no approved or proven nondietary treatment is available .


In this multicenter , randomized , double-blind , placebo-controlled study , we assessed larazotide acetate 0.5 , 1 , or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study .


The study included a 4-week placebo run-in , 12 weeks of treatment , and a 4-week placebo run-out phase .


The primary end point was the difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score .


The primary end point was met with the 0.5-mg dose of larazotide acetate , with fewer symptoms compared with placebo by modified intention to treat ( n = 340 ) ( analysis of covariance , P = .022 ; mixed model for repeated measures , P = .005 ) .


The 0.5-mg dose showed an effect on exploratory end points including a 26 % decrease in celiac disease patient-reported outcome symptomatic days ( P = .017 ) , a 31 % increase in improved symptom days ( P = .034 ) , a 50 % or more reduction from baseline of the weekly average abdominal pain score for 6 or more of 12 weeks of treatment ( P = .022 ) , and a decrease in the nongastrointestinal symptoms of headache and tiredness ( P = .010 ) .


The 1 - and 2-mg doses were no different than placebo for any end point .


Safety was comparable with placebo .


Larazotide acetate 0.5 mg reduced signs and symptoms in CeD patients on a GFD better than a GFD alone .


Although results were mixed , this study was a successful trial of a novel therapeutic agent targeting tight junction regulation in patients with CeD who are symptomatic despite a GFD .


Clinicaltrials.gov : NCT01396213 .


To evaluate the effect of eculizumab , a systemic inhibitor of complement component ( C5 ) , on the growth of geographic atrophy ( GA ) in patients with age-related macular degeneration ( AMD ) .


Prospective , double-masked , randomized clinical trial .


Patients with GA measuring from 1.25 to 18 mm ( 2 ) based on spectral-domain optical coherence tomography imaging .


Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 6 months .


In the eculizumab treatment arm , the first 10 patients received a low-dose regimen of 600 mg weekly for 4 weeks followed by 900 mg every 2 weeks until week 24 , and the next 10 patients received a high-dose regimen of 900 mg weekly for 4 weeks followed by 1200 mg every 2 weeks until week 24 .


The placebo group was infused with saline .


Patients were observed off treatment for an additional 26 weeks .


Both normal-luminance and low-luminance visual acuities were measured throughout the study , and the low-luminance deficits were calculated as the difference between the letter scores .


Change in area of GA at 26 weeks .


Thirty eyes of 30 patients were enrolled .


Eighteen fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint .


For the 30 study eyes , mean square root of GA area measurements standard deviation at baseline were 2.55 0.94 and 2.02 0.74 mm in the eculizumab and placebo groups , respectively ( P = 0.13 ) .


At 26 weeks , GA enlarged by a mean of 0.19 0.12 and 0.18 0.15 mm in the eculizumab and placebo groups , respectively ( P = 0.96 ) .


At 52 weeks of follow-up , GA enlarged by a mean of 0.37 0.22 mm in the eculizumab-treated eyes and by a mean of 0.37 0.21 mm in the placebo group ( P = 0.93 , 2 sample t test ) .


None of the eyes converted to wet AMD .


No drug-related adverse events were identified .


Systemic complement inhibition with eculizumab was well tolerated through 6 months but did not decrease the growth rate of GA significantly .


However , there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over 6 months .


We present a clinical trial establishing the feasibility of a control-to-range ( CTR ) closed-loop system informed by heart rate ( HR ) and assess the effect of HR information added to CTR on the risk for hypoglycemia during and after exercise .


Twelve subjects with type 1 diabetes ( five men , seven women ; weight , 68.9 3.1 kg ; age , 38 3.3 years ; glycated hemoglobin , 6.9 0.2 % ) participated in a randomized crossover clinical trial comparing CTR versus CTR+HR in two 26-h admissions , each including 30 min of mild exercise .


The CTR algorithm was implemented in the DiAs portable artificial pancreas platform based on an Android ( ) ( Google , Mountainview , CA ) smartphone .


We assessed blood glucose ( BG ) decline during exercise , the Low BG Index ( LBGI ) ( a measure of hypoglycemic risk ) , number of hypoglycemic episodes ( BG < 70 mg/dL ) and overall glucose control ( percentage time within the target range 70 mg/dL BG 180 mg/dL ) .


Using HR to inform the CTR algorithm reduced significantly the BG decline during exercise ( P = 0.022 ) , indicated marginally lower LBGI ( P = 0.3 ) and fewer hypoglycemic events during exercise ( none vs. two events ; P = 0.16 ) , and resulted in overall higher percentage time within the target range ( 81 % vs. 75 % ; P = 0.2 ) .


LBGI and average BG remained unchanged overall , during recovery , and overnight .


HR-informed closed-loop control can be implemented in a portable artificial pancreas .


Although closed loop has been shown to reduce hypoglycemia , adding HR signal may further limit the risk for hypoglycemia during and immediately after exercise .


The most prominent effect of adding HR information is reduced BG decline during exercise , without deterioration of overall glycemic control .


Electroconvulsive therapy ( ECT ) is regarded by many clinicians as the most effective treatment for treatment-resistant bipolar depression , but no randomized controlled trials have been conducted , to the authors ' knowledge .


They compared efficacy measures of ECT and algorithm-based pharmacological treatment in treatment-resistant bipolar depression .


This multicenter , randomized controlled trial was carried out at seven acute-care psychiatric inpatient clinics throughout Norway and included 73 bipolar disorder patients with treatment-resistant depression .


The patients were randomly assigned to receive either ECT or algorithm-based pharmacological treatment .


ECT included three sessions per week for up to 6 weeks , right unilateral placement of stimulus electrodes , and brief pulse stimulation .


Linear mixed-effects modeling analysis revealed that ECT was significantly more effective than algorithm-based pharmacological treatment .


The mean scores at the end of the 6-week treatment period were lower for the ECT group than for the pharmacological treatment group : by 6.6 points on the Montgomery-sberg Depression Rating Scale ( SE = 2.05 , 95 % CI = 2.5-10 .6 ) , by 9.4 points on the 30-item version of the Inventory of Depressive Symptomatology-Clinician-Rated ( SE = 2.49 , 95 % CI = 4.6-14 .3 ) , and by 0.7 points on the Clinical Global Impression for Bipolar Disorder ( SE = 0.31 , 95 % CI = 0.13-1 .36 ) .


The response rate was significantly higher in the ECT group than in the group that received algorithm-based pharmacological treatment ( 73.9 % versus 35.0 % ) , but the remission rate did not differ between the groups ( 34.8 % versus 30.0 % ) .


Remission rates remained modest regardless of treatment choice for this challenging clinical condition .


To determine whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department ( PACCI-ED ) , a 12-item questionnaire , can help ED attendings accurately assess a patient 's asthma control and morbidity .


This was a randomized-controlled trial performed at an urban pediatric ED of children aged 1-17 years presenting with an asthma exacerbation .


Parents answered PACCI-ED questions about their children 's asthma .


Attendings were randomized to view responses to the PACCI-ED ( intervention group ) or to be blinded to the completed PACCI-ED ( control group ) .


The two groups were compared on their empirical clinical assessment of : ( 1 ) chronic asthma control categories , ( 2 ) asthma trajectory ( stable , worsening or improving ) , ( 3 ) patient adherence to controller medications , and ( 4 ) burden of disease for the patient 's family .


The validated PACCI algorithm was used as the criterion standard for these four outcomes .


Accuracy of clinical assessment was compared between intervention and control groups using chi-squared tests and an intention-to-treat approach .


Seventeen ED attendings were enrolled in the study and 77 children visits were included in the analysis .


There were no significant differences between the intervention and the control groups for child 's gender , age , race , and asthma characteristics .


Intervention group attendings were more accurate than control group attendings in assessing the category of chronic asthma control ( 43 % versus 19 % ; p = 0.03 ) , disease trajectory ( 72 % versus 45 % ; p = 0.02 ) , and the disease burden for families ( 74 % versus 35 % ; p = 0.001 ) over the past 12 months .


There was a trend towards more accuracy of intervention versus control attendings for estimating patient adherence to controller medications ( 72 % versus 48 % ; p = 0.06 ) .


The PACCI-ED improves the assessment of asthma control , trajectory , and burden by ED attendings , and may help assessment of asthma medication adherence and prior asthma exacerbations .


The PACCI-ED can be used to improve provider assessment of asthma morbidity during pediatric ED visits for asthma exacerbations , and to identify children who may benefit from interventions to reduce asthma morbidity .


Remote ischemic preconditioning by transient limb ischemia reduces myocardial ischemia-reperfusion injury in patients undergoing percutaneous coronary intervention .


The aim of the study we report here was to assess the effect of remote ischemic preconditioning on endothelial function in patients with acute myocardial infarction who underwent primary percutaneous coronary intervention .


Forty-eight patients with acute myocardial infarction were enrolled .


All participants were randomly divided into 2 groups .


In Group I ( n = 23 ) , remote ischemic preconditioning was performed before primary percutaneous coronary intervention ( intermittent arm ischemia-reperfusion through 4 cycles of 5-minute inflation and 5-minute deflation of a blood-pressure cuff to 200 mm Hg ) .


In Group II ( n = 25 ) , standard percutaneous coronary intervention without preconditioning was performed .


We assessed endothelial function using the flow-mediated dilation test on baseline , then within 1-3 hours after percutaneous coronary intervention , and again on days 2 and 7 after percutaneous coronary intervention .


The brachial artery flow-mediated dilation results were significantly higher on the first day after primary percutaneous coronary intervention in the preconditioning group ( Group I ) than in the control group ( Group II ) ( 12.1 % vs 0.0 % , P = .03 , and 11.1 % vs 6.3 % , P = .016 , respectively ) , and this difference remained on the seventh day ( 12.3 % vs 7.4 % , P = .0005 , respectively ) .


We demonstrated for the first time that remote ischemic preconditioning before primary percutaneous coronary intervention significantly improves endothelial function in patients with acute myocardial infarction , and this effect remains constant for at least a week .


We suppose that the improvement of endothelial function may be one of the possible explanations of the effect of remote ischemic preconditioning .


The use of email and website as channels for workplace health information delivery is not fully explored .


This study aims to describe the rationale , design , and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors .


Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention ( n = 174 ) or control group ( n = 165 ) .


A website was developed for the intervention and educational modules were uploaded onto the website .


The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none .


Diet , lifestyle , anthropometric measurements , psychosocial factors and stages of change related to dietary fat , fruit and vegetable intake , and physical activity were assessed .


Participants were predominantly female and in non-academic positions .


Obesity was prevalent in 15 % and 37 % were at risk of co-morbidities .


Mean intake of fats was 31 % , fruit was -1 serving/day and vegetable was < 1 serving/day .


Less than 20 % smoked and drank alcohol and about 40 % were physically inactive .


The majority of the participants fell into the Preparation stage for decreasing fat intake , eating more fruit and vegetables , and increasing physical activity .


Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages .


Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention .


Hence the findings warrant the intervention planned .


The TACT trial ( CRUK/01/001 ) compared adjuvant sequential FEC-docetaxel ( FEC-D ) chemotherapy with standard anthracycline-based chemotherapy of similar duration in women with early breast cancer .


Results at a median of 5 years suggested no improvement in disease-free survival with FEC-D .


Given differing toxicity profiles of the regimens , the impact on quality of life ( QL ) was explored .


Patients from 44 centres completed standardised QL questionnaires before chemotherapy , after cycles 4 and 8 , at 9 , 12 , 18 and 24 months and at 6 years follow-up .


Patient diaries assessed frequency , associated distress and impact on daily activity of 15 treatment related side effects .


830 patients ( 415 FEC-D ; 415 controls ) contributed assessments during 0-24 months ; 362 of whom participated again at 6 years .


During chemotherapy , FEC-D impaired global health/QL and depression rates and significantly more QL domains than standard regimens .


Novel diary card ratings highlighted significantly more distress and interference with daily activities due to FEC-D side effects compared with standard treatment .


In both groups , most QL parameters returned to baseline levels by 2 years and were unchanged at 6 years .


Within expected negative effects of chemotherapy on wide ranging QL domains FEC-D patients reported greater toxicity , disruption and distress during treatment with no improvement in disease outcome at 5 years than patients receiving standard anthracycline-based chemotherapy .


Findings should inform future patients of relative costs and benefits of adjuvant chemotherapy .


The combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression ( OFS ) compared with tamoxifen plus OFS .


We present patient-reported outcomes from these trials .


Between Nov 7 , 2003 , and April 7 , 2011 , 4717 premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with 5 years of exemestane plus OFS or tamoxifen plus OFS .


Gonadotropin-releasing hormone analogue triptorelin , bilateral oophorectomy , or bilateral ovarian irradiation were used to achieve OFS .


Chemotherapy use was optional .


Randomisation with permuted blocks was done with the International Breast Cancer Study Group 's internet-based system and was stratified by chemotherapy use and status of lymph nodes .


Patients completed a quality of life ( QoL ) form comprising several global and symptom indicators at baseline , every 6 months for 24 months , and then every year during years 3 to 6 .


Differences in the change of QoL from baseline between the two treatments were tested at 6 months , 24 months , and 60 months with mixed-models for repeated measures for each trial with and without chemotherapy and overall .


The analysis was by intention to treat .


At the time of analysis , the median follow-up was 57 years ( IQR 37-69 ) ; treatment and follow-up of patients continue .


The trials are registered with ClinicalTrials.gov , as NCT00066703 ( TEXT ) and NCT00066690 ( SOFT ) .


Patients on tamoxifen plus OFS were more affected by hot flushes and sweats over 5 years than were those on exemestane plus OFS , although these symptoms improved .


Patients on exemestane plus OFS reported more vaginal dryness , greater loss of sexual interest , and difficulties becoming aroused than did patients on tamoxifen plus OFS ; these differences persisted over time .


An increase in bone or joint pain was more pronounced , particularly in the short term , in patients on exemestane plus OFS than patients on tamoxifen plus OFS .


Changes in global QoL indicators from baseline were small and similar between treatments over the 5 years .


Overall , from a QoL perspective , there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS .


The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually .


Pfizer , International Breast Cancer Study Group , and US National Cancer Institute .


Coaction refers to the extent to which taking action on one behavior increases the odds of taking action on a second behavior .


This integrative study examines the generalization of coaction in three studies on weight-related behaviors .


Data from three randomized trials of tailored interventions ( n = 1,277 , n = 1,800 , and n = 6,000 ) were examined to determine if coaction of behavior change occurred differentially in treatment and control groups .


In each analysis , the likelihood of progressing to the Action or Maintenance stages for the target behaviors was evaluated using logistic regression .


Despite differences in populations , targeted behaviors , levels of tailoring in interventions , and timing of follow-up assessments , 17 out of 24 ( 70.8 % ) logistic regressions revealed significant coaction in the treatment group as opposed to only three out of 24 ( 12.5 % ) in the control condition .


In 23/24 analyses , coaction of behavior change was larger on an absolute basis in the treatment group .


Individuals in the treatment group progressing to Action/Maintenance for one behavior were 1.4-5 times more likely to make progress on another behavior compared to those in the treatment group who did not make such progress on the first behavior .


This study demonstrates that despite considerable variability in study design , coaction reliably occurs more in the presence of Transtheoretical-Model based multiple behavior change interventions .


Additional studies are needed to replicate these results in other behavioral areas and to examine the predictors of differential coaction .


The ability to consistently create coaction within multiple behavior interventions can increase the efficacy and cost-effectiveness of multiple behavior change interventions .


Routine tuberculosis culture remains unavailable in many high-burden areas , including Tanzania .


This study sought to determine the impact of providing mycobacterial culture results over standard of care [ unconcentrated acid-fast ( AFB ) smears ] on management of persons with suspected tuberculosis .


Adults and children with suspected tuberculosis were randomized to standard ( direct AFB smear only ) or intensified ( concentrated AFB smear and tuberculosis culture ) diagnostics and followed for 8weeks .


The primary endpoint was appropriate treatment ( i.e. antituberculosis therapy for those with tuberculosis , no antituberculous therapy for those without tuberculosis ) .


Seventy participants were randomized to standard ( n = 37 , 53 % ) or intensive ( n = 33 , 47 % ) diagnostics .


At 8weeks , 100 % ( n = 22 ) of participants in follow up randomized to intensive diagnostics were receiving appropriate care , vs. 22 ( 88 % ) of 25 participants randomized to standard diagnostics ( p = 0.14 ) .


Overall , 18 ( 26 % ) participants died ; antituberculosis therapy was associated with lower mortality ( 9 % who received antiuberculosis treatment died vs. 26 % who did not , p = 0.04 ) .


Under field conditions in a high burden setting , the impact of intensified diagnostics was blunted by high early mortality .


Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve .


Patients with frontal lobe epilepsy ( FLE ) commonly demonstrate motor impairments , suggesting that frontal lobe seizures affect motor function .


However , the underlying mechanisms of these deficits are not known , nor has any study systematically examined motor organization in these patients .


We therefore examined cortical motor organization in a group of adult patients with FLE , using task-based fMRI .


Eleven right FLE patients , six left FLE patients , and ten control subjects underwent task-based fMRI .


Two tasks were performed using the right and left hands separately , and both hands together .


The first task was a finger-tapping task and the second task was a more complex coordination task .


Functional MR data were compared between patient groups and controls .


A laterality index of brain activation was also calculated between the epileptic and healthy hemisphere to determine hemispheric dominance during task performance to explore its relationship with a variety of patient-specific epilepsy factors .


Overall , right FLE patients demonstrated decreased BOLD activity in the epileptic hemisphere and increased BOLD activity in the healthy hemisphere compared to controls ( p < 0.05 ) .


The comparison of left FLE patients to controls provided less conclusive differences , possibly due to the low number of left FLE patients studied .


Laterality indices of the coordination task were positively correlated to the number of months since the last seizure in both patient groups ( right FLE : rs = 0.779 , left FLE : rs = 0.943 ) .


Patients that had experienced a recent seizure relied more on the sensorimotor cortex of the healthy hemisphere during task performance , compared to those that were relatively seizure free ( p < 0.05 ) .


Patients with FLE exhibited changes in motor BOLD activity that was dependent on the duration of seizure freedom .


These results demonstrate the presence of seizure-related alteration of cortical motor organization in FLE , which may underlie the motor deficits seen in these patients .


To examine the psychological sequelae associated with abnormal screening in the United Kingdom Collaborative Trial of Ovarian Cancer Screening ( UKCTOCS ) .


Prospective , longitudinal randomised control trial .


Sixteen UKCTOCS centres .


Women aged 50-70 years randomised to annual multimodal screening , ultrasound screening or control groups .


Two groups were followed for 7 years : ( 1 ) a random sample ( n = 1339 ) , taken from all three study groups ; and ( 2 ) an events sample ( n = 22,035 ) of women with abnormal screens resulting in the need for repeat testing of either low or higher level intensity .


Patient-reported measures of anxiety ( scores ranging from 20 to 80 ) and psychological morbidity .


In the random sample the mean difference between anxiety scores after a repeat screening and those following an annual screening was 0.4 ( 95 % CI -0.46 , 1.27 ) , and in the events sample it was 0.37 ( 95 % CI 0.23 , 0.51 ) .


The risk of psychological morbidity was only increased in the event sample for women requiring higher level repeat screening ( OR 1.28 ; 95 % CI 1.18 , 1.39 ) .


The risk of psychological morbidity in women with ovarian cancer was higher at both 6 weeks ( OR 16.2 ; 95 % CI 9.19 , 28.54 ) and 6 months ( OR 3.32 ; 95 % CI 1.91 , 5.77 ) following surgery .


Screening does not appear to raise anxiety but psychological morbidity is elevated by more intense repeat testing following abnormal annual screens , and in women after surgical treatment for ovarian cancer .


Lactate is a marker of hypoperfusion and may be used for risk assessment in critically ill patients .


Although evidence suggests that repeated lactate measurements are of clinical interest , how and when lactate should be analyzed is controversial .


Intravascular microdialysis provides a novel method for the continuous monitoring of lactate , which may be clinically beneficial in critically ill patients .


Circulating lactate levels were continuously monitored in 80 patients undergoing cardiac surgery using either a separate single-lumen microdialysis catheter or a triple-lumen central venous catheter with an integrated microdialysis function .


The catheter was placed with the tip positioned in the superior vena cava .


Arterial blood gas samples were taken every hour to obtain reference values , and the lactate levels were analyzed in a blood gas analyzer .


A total of 1,601 paired microdialysis-arterial blood gas lactate samples were obtained .


Bland-Altman analysis showed a bias ( mean difference ) limits of agreement ( 1.96 SD ) of 0.020.42 mmol/L .


The regression coefficient was 0.98 ( P = 0.0001 ) .


Central venous microdialysis is an accurate and reliable method for continuous blood lactate monitoring in patients undergoing cardiac surgery .


The system may be useful for early lactate-guided therapy in critically ill patients .


The objective of this study was to evaluate and compare the effects of gliclazide-modified release ( gliclazide-MR ) , metformine ( MET ) and pioglitazone ( PIO ) monotherapies on glycemic control and conventional/non-conventional cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus ( T2DM ) .


A single center , randomized , 52-wk comparator-controlled clinical study was carried out in patients with newly diagnosed uncontrolled T2DM .


A total of 57 patients were randomized into gliclazide-MR , metformin and pioglitazone groups .


Drugs were administered for 12 months .


Anthropometric measurements , fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPG ) , HbA1c , insulin , HOMA-IR , lipid parameters , the markers of coagulation/fibrinolysis , inflammation and endothelial dysfunction were measured at baseline and at months 3 , 6 , and 12 .


In the gliclazide-MR group , HC , FPG , HbA1c , insulin , HOMA-IR , TC , trigylcerides , Lp ( a ) , E-selectin and Hcy were significantly decreased after treatment compared to baseline .


In the MET group , BMI , WC , FPG , PPG , HbA1c , ICAM-1 and Hcy significantly decreased after treatment compared to baseline .


In PIO group , WC , HC , FPG , PPG , HbA1c , C-peptid , HOMA-IR , trigylcerides , vWF , IL-6 , ICAM-1 , E-selectin and Hcy significantly decreased after treatment compared to baseline , whereas , HDL-C increased .


At the end of the month 12 , the decreases in insulin and HOMA-IR score were more pronounced with PIO compared to gliclazide .


Gliclazide-MR , MET and PIO monotherapies , were equally effective in proving glycemic control in patients with newly diagnosed , oral antidiabetic ( OAD ) - naive T2DM .


But , improvements in conventional/non-conventional cardiovascular risk factors were more pronounced in patients on PIO therapy compared to gliclazide and MET therapies .


Also , all of the 3 drugs represent effective and safe first-line pharmacological treatment options in these patients .


In our increasingly obesogenic environment , in which high-calorie convenience foods are readily available , food choices can drastically affect weight and overall health .


Learned food preferences , which are developed through repeated pairings with positively and negatively valenced stimuli , can contribute to obesity susceptibility if positive attitudes toward high-calorie foods are developed .


Thus , the modification of automatic associations with food may be a viable strategy to promote healthier eating behaviors .


In this study , we investigated the ability of an implicit priming ( IP ) intervention to alter responses to visual food cues by using an evaluative conditioning approach .


The main objective was to implicitly ( i.e. , below conscious perception ) associate disgust with high-calorie foods with the aim of reducing liking of these foods .


Participants were randomly assigned to active or control IP .


In active IP ( n = 22 ) , high-calorie food images were implicitly primed with negatively valenced images , and low-calorie food images were implicitly primed with positively valenced images .


In control IP ( n = 20 ) , all food images were primed with neutral images of fixation crosses .


Food images were rated on the desire to eat immediately before and after IP .


A significant main effect of calorie ( high compared with low ; P < 0.001 ) and a significant calorie-by-group ( active compared with control ) interaction ( P = 0.025 ) were observed .


Post hoc tests identified a significantly greater high-calorie rating decline after active IP than after control IP ( P = 0.036 ) .


Furthermore , there was significantly greater change in high-calorie ratings than in low-calorie ratings in the active group ( P = 0.001 ) .


Active IP effects extended to high-calorie foods not specifically included in the intervention , which suggested an effect generalization .


Moreover , a greater change in high-calorie ratings than in low-calorie ratings persisted 3-5 d after active IP ( P < 0.007 ) , which suggested lasting effects .


This study provides initial evidence that IP can be used to alter high-calorie food preferences , which could promote healthier eating habits .


To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve ( AGV ) ( New World Medical , Cucamonga , CA ) and the Baerveldt Glaucoma Implant ( BGI ) 101-350 ( Abbott Medical Optics , Abbott Park , IL ) for the treatment of refractory glaucoma .


Multicenter , randomized , controlled clinical trial .


A total of 276 patients : 143 in the AGV group and 133 in the BGI group .


Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures ( IOPs ) 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI .


The IOP , visual acuity ( VA ) , supplemental medical therapy , complications , and failure ( IOP > 21 mmHg or not reduced by 20 % from baseline , IOP < 5 mmHg , reoperation for glaucoma or removal of implant , or loss of light perception vision ) .


At 3 years , IOP ( mean standard deviation ) was 14.3 4.7 mmHg ( AGV group ) and 13.1 4.5 mmHg ( BGI group ) ( P = 0.086 ) on 2.0 1.4 and 1.5 1.4 glaucoma medications , respectively ( P = 0.020 ) .


The cumulative probabilities of failure were 31.3 % ( standard error [ SE ] , 4.0 % ) ( AGV ) and 32.3 % ( 4.2 % ) ( BGI ) ( P = 0.99 ) .


Postoperative complications associated with reoperation or vision loss of > 2 Snellen lines occurred in 24 patients ( 22 % ) ( AGV ) and 38 patients ( 36 % ) ( BGI ) ( P = 0.035 ) .


The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar ( AGV : 0.21 0.88 , BGI : 0.26 0.74 ) in the 2 treatment groups at 3 years ( P = 0.66 ) .


The cumulative proportion of patients ( SE ) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5 % ( 3.0 % ) in the AGV group compared with 7.6 % ( 2.4 % ) in the BGI group ( P = 0.053 , log rank ) .


The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group ( 95 % confidence interval , 1.0-4 .8 ; P = 0.045 , Cox proportional hazards regression ) .


Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma .


More subjects experienced serious postoperative complications in the BGI group than in the AGV group .


A new treatable venous disorder , chronic cerebrospinal venous insufficiency ( CCSVI ) , has been proposed in patients with multiple sclerosis .


The natural course of CCSVI has not been examined yet .


This is crucial given the fact that surgical procedures are increasingly offered to MS patients to treat venous stenosis .


To document the natural course of venous haemodynamics we performed extra - and transcranial echo colour Doppler ( ECD ) in 52 multiple sclerosis patients and 28 healthy controls ( HC ) and re-examined this group after a median period of 16 weeks .


The reexamination was done being blinded to the initial findings and the patients did not undergo any intervention .


The ECD examination at baseline showed CCSVI in 5 ( 9.6 % ) of the 52 multiple sclerosis patients and 0 HC ( P = 0.26 ) .


At follow-up the diagnosis CCSVI could not be reconfirmed in 3 out of 5 patients at follow-up , while 2 new CCSVI-positive multiple sclerosis patients were detected .


ECD examination shows a fluctuating natural course of the extracranial venous haemodynamics , which makes determination of CCSVI by ECD examination unreliable .


To explore the effective method of the prevention and treatment of procedural pain in dressing changes of burn wounds .


Ninety patients of burn injury were randomized into 3 groups , 30 cases in each one .


In the group A , fentanyl citrate injection was used at corresponding injury area , jiaogan ( AH6a , sympathetic nerve ) , fei ( CO14 , lung ) , neifenmi ( CO18 , endocrine ) on ear , 0.25 mL at each point .


In the group B , fentanyl citrate injection was applied subcutaneously in the deltoid muscle , 1 mL .


In the group C , 0.9 % sodium chloride injection was applied subcutaneously in the deltoid muscle , 1 mL .


The visual analogue scale ( VAS ) was used to evaluate the analgesic effect before , during and 10 min after dressing change in the patients of the three groups separately .


It was not different in VAS score before dressing change among the three groups ( P > 0.05 ) .


Compared with that before dressing change , the pain was not significant and VAS score was not different during and after dressing change in the patients of the group A ( both P > 0.05 ) , but the score in the patients of the group B and C was different significantly ( all P < 0.05 ) .


The VAS score during and after dressing change in the group A was lower than that in the group B and C ( all P < 0.05 ) , and the score in the group B was lower than that in the group C ( P < 0.05 ) .


Fentanyl injection of small dose at auricular points achieves definite analgesic effect on procedural pain in dressing changes of burn wounds , superior to subcutaneous injection of fentanyl .


In insulin-requiring type 2 diabetes patients , current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections ( MDI ) have not consistently provided achievement of optimal glycemic control .


Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion ( CSII ) in these patients .


The OpT2mise study is a multicenter , randomized , trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy .


Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen .


Subjects showing persistent hyperglycemia ( glycated hemoglobin [ HbA1c ] 8 % and 12 % ) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm , switching to CSII .


The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months .


Secondary end points include change in mean 24-h glucose values , area under the curve and time spent in hypoglycemia and hyperglycemia , measures of glycemic excursions , change in postprandial hyperglycemia , and evaluation of treatment satisfaction .


Safety end points include hypoglycemia , hospital admissions , and emergency room visits .


When subject enrollment was completed in May 2013 , 495 subjects had been enrolled in the study .


The study completion for the primary end point is expected in January 2014 .


OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy .


OpT2mise will help define the role of CSII in insulin intensification and define its safety , rate of hypoglycemia , patient adherence , and patient satisfaction .


To explore the effect of autologous cytokine-induced killer cells on the quality of life in patient with breast cancer who have already finished the adjuvant chemotherapy .


One hundred and twenty-eight postoperative patients with breast cancer who underwent anthracycline-based adjuvant chemotherapy were enrolled in this prospective study , and they were randomized into 2 groups , i.e. , treatment group , which received the therapy of CIK cells transfusion , and control group , which was given regular follow-up .


Meanwhile , patients with positive hormone receptor in the two groups were given endocrine therapy , and the patients with positive axillary lymph nodes were given radiotherapy to the chest wall and regional lymph nodes .


The difference of quality of life between the two groups was analyzed according to the EORTC QLQ-BR53 quality of life questionnaire , and the adverse reactions were monitored .


As regarding the functional evaluation , the physical function scores of patients of the treatment group were ( 83.43 14.87 ) and ( 88.55 11.62 ) at 3 and 6 months after the CIK cell therapy , respectively , significantly higher than the baseline value [ ( 74.83 13.82 ) , P < 0.05 ) ] .


Global health status/QOL scores were ( 83.30 19.09 ) and ( 89.68 10.81 ) , significantly higher than the baseline value [ ( 77.72 21.05 ) , P < 0.05 ] .


As regarding symptoms , the scores of fatigue , nausea , vomiting and loss of appetite of patients in the treatment group were higher than the baseline value , with significant differences ( P < 0.05 ) .


The nausea and vomiting scores in the control group at 3 and 6 months of followed-up were ( 26.67 22.56 ) and ( 21.47 21.06 ) , significantly lower than the baseline values [ ( 33.31 27.07 ) , P < 0.05 ] .


The scores of worrying about the future in the patients of treatment group were ( 47.56 30.84 ) and ( 42.33 26.95 ) after 3 and 6 months , significantly better than the baseline value [ ( 57.41 30.63 ) , P < 0.05 ] .


The systematic therapy side effects scores were ( 31.95 27.52 ) and ( 23.72 22.87 ) , significantly better than the baseline value [ ( 40.56 26.28 ) , P < 0.05 ] .


The scores of arm edema were ( 45.26 25.42 ) and ( 36.61 20.51 ) , significantly milder than the baseline value [ ( 55.11 22.82 ) , P < 0.05 ] .


In the control group , the scores of arm edema were ( 44.85 28.94 ) and ( 38.64 23.68 ) , significantly lower than the baseline values [ ( 53.26 23.84 ) points , P < 0.05 ] .


Alopecia scores were ( 29.93 24.72 ) and ( 24.18 22.66 ) , significantly lower than the baseline values [ ( 35.92 22.08 ) , P < 0.05 ] .


In the treatment group , the patients ' physical function , social function and global health status/QOL , fatigue , insomnia , and worrying about the future rates were significantly higher than that of the control group ( P < 0.05 for all ) .


Three patients after CIK reinfusion had transient fever , and 6 cases felt pain in the lower limb , but the symptoms were relieved after symptomatic treatment .


Therapy of autologous CIK cells transfusion can significantly improve the quality of life of breast cancer patients , and the adverse reactions during the treatment can be alleviated by symptomatic treatment .


In this partially randomised intervention study , we assessed the effect of social networks on the improvement of type 2 diabetes management in a largely African-American population in Baltimore .


Patients in the intervention group ( n = 68 ) were asked to recruit peers , form small groups , and attend monthly diabetes education sessions , emphasising peer support .


Patients in the control group ( n = 70 ) were recruited individually to attend standard diabetes education sessions .


The primary outcomes were changes in haemoglobin A1C ( HbA1c ) and blood glucose .


Secondary outcomes included blood pressure , weight , functional status , self-efficacy , perceived cohesion , social network connectedness and diabetes knowledge .


General linear mixed models were built to assess mean absolute changes in primary and secondary outcomes at 3 and 6 months .


At 6 months from baseline , the social network intervention group achieved a larger reduction in HbA1c of -0.32 % ( p < 0.0001 ) and blood glucose of -10.6 mg/dL , ( p < 0.0001 ) compared to the control group .


In analyses of secondary endpoints , the intervention group had more favourable outcomes over time for weight , quality of life , self-efficacy , social network scores and diabetes knowledge , compared to the control group .


While blood pressure decreased , and perceived cohesion increased in both groups over the duration of the study , the difference between groups was not statistically significant .


The social networks intervention showed improved integration of patients within their existing networks leading to a greater reduction in HbA1c and blood glucose , as well as improved behaviour mediating outcomes .


While there is a dose-response relationship between physical activity ( PA ) and health benefit , little is known about the effectiveness of different PA prescriptions on total daily PA. .


To test , under real-life conditions and using an objective , non-invasive measurement technique ( accelerometry ) , the effect of prescribing additional physical activity ( walking only ) of different durations ( 30 , 60 and 90 min/day ) on compliance ( to the activity prescribed ) and compensation ( to total daily PA ) .


Participants in each group were prescribed 5 sessions of walking per week over 4 weeks .


55 normal-weight and overweight women ( mean BMI 25 5 kg/m ( 2 ) , height 165 1 cm , weight 68 2 kg and mean age 27 1 years ) were randomly assigned to 3 prescription groups : 30 , 60 or 90 min/day PA. .


Walking duration resulted in an almost linear increase in the number of steps per day during the prescription period from an average of about 10,000 steps per day for the 30-min prescription to about 14,000 for the 90-min prescription .


Compliance was excellent for the 30-min prescription but decreased significantly with 60-min and 90-min prescriptions .


In parallel , degree of compensation subsequent to exercise increased progressively as length of prescription increased .


A 30-min prescription of extra walking 5 times per week was well tolerated .


However , in order to increase total PA further , much more than 60 min of walking may need to be prescribed in the majority of individuals .


While total exercise ` volume ' increased with prescriptions longer than 30 min , compliance to the prescription decreased and greater compensation was evident .


Many national colorectal cancer screening campaigns have a similar structure .


First , individuals are invited to take a noninvasive screening test , and , second , in the case of a positive screening test result , they are advised to undergo a more invasive follow-up test .


The objective of this study was to investigate how much individuals ' participation decision in noninvasive screening is affected by the presence or absence of detailed information about invasive follow-up testing and how this effect varies over screening tests .


We used a labeled discrete choice experiment of three noninvasive colorectal cancer screening types with two versions that did or did not present respondents with detailed information about the possible invasive follow-up test ( i.e. , colonoscopy ) and its procedure .


We used data from 631 Dutch respondents aged 55 to 75 years .


Each respondent received only one of the two versions ( N = 310 for the invasive follow-up test information specification version , and N = 321 for the no-information specification version ) .


Mixed logit model results show that detailed information about the invasive follow-up test negatively affects screening participation decisions .


This effect can be explained mainly by a decrease in choice shares for the most preferred screening test ( a combined stool and blood sample test ) .


Choice share simulations based on the discrete choice experiment indicated that presenting invasive follow-up test information decreases screening participation by 4.79 % .


Detailed information about the invasive follow-up test has a negative effect on individuals ' screening participation decisions in noninvasive colorectal cancer screening campaigns .


This result poses new challenges for policymakers who aim not only to increase uptake but also to provide full disclosure to potential screening participants .


The purpose of this study was to examine the influence of instrument assisted soft tissue techniques ( IASTT ) on myofascial trigger points ( MTrP ) .


Randomized , controlled study with the researcher assessing the MTrP sensitivity blinded to the treatment rendered .


Phase 1 = 27 ; Phase 2 = 22 .


MTrPs were identified in the upper back .


In phase 1 , two MTrPs ( right & left ) were identified .


One was treated with IASTT , the other was a control .


In phase 2 , one MTrP was identified in a treatment and a control group .


In each phase , the treatment groups received six treatments of IASTT .


Sensitivity threshold of the MTrP was assessed with a dolorimeter .


There was a significant improvement in both groups over time but there was no difference between the treatment and control groups .


The use of a pressure dolorimeter may have served as a form of ischemic compression treatment .


This assessment tool may have been a mitigating factor in the over-shadowing any potential influence of the IASTT on the MTrP .


Thus , another assessment tool needs to be identified for MTrP assessment .


Until that technique is identified , the effect of IASTT on MTrPs in inconclusive .


Nowadays , advanced irradiation techniques make it possible to escalate safely the dose in prostate cancer .


We studied the effect of a higher dose on tumor control in a randomized trial with a median follow-up of 110 months .


Patients with T1b-T4N0 prostate cancer ( n = 664 ) were randomized between 78 Gy and 68 Gy .


Primary endpoint was biochemical and/or clinical failure ( BCF ) according to the American Society for Therapeutic Radiology and Oncology ( ASTRO ) guidelines ( 3 consecutive rises ) , and to Phoenix ( nadir plus 2 g/L ) .


Secondary endpoints were clinical failure ( CF ) , local failure ( LF ) , prostate cancer death ( PCD ) , and overall survival ( OS ) .


Explorative subgroup analyses were performed .


BCF rate ( HR = 0.8 ; 20 % less events ) and LF rate ( HR = 0.5 ; 50 % less events ) were significantly lower in the 78 Gy arm ( p < 0.05 ) .


CF , PCD and OS were similar in both arms .


A significant heterogeneity of treatment effect was found for PSA cutoffs between 7 and 10 g/L .


We observed significantly less BCF and LF in the high-dose arm .


This suggests improvement of the therapeutic ratio .


However , we observed similar rates of CF and PCD at the current update .


More follow-up is needed to investigate which patients benefit in terms of prolonged OS .


Breast cancer is characterized by great molecular heterogeneity demonstrated , e.g. by the intrinsic subtypes .


Administration of post-mastectomy radiotherapy ( PMRT ) does , however , not reflect this heterogeneity .


A gene profile ( DBCG-RT profile ) has recently been developed and validated , and has shown prognostic impact in terms of loco-regional failure and predictive impact for PMRT .


Reports have also shown predictive value in terms of benefit of PMRT from intrinsic subtypes and derived approximations .


The aim of this study was to examine : 1 ) the agreement between various methods for determining the intrinsic subtypes ; and 2 ) the relationship between the prognostic and predictive impact of the DBCG-RT profile and the intrinsic subtypes .


Intrinsic subtypes and the DBCG-RT profile was determined from microarray analysis based on fresh frozen tissue from 191 patients included in the Danish Breast Cancer Cooperative Group ( DBCG ) 82bc trial .


Corresponding formalin-fixed , paraffin-embedded tissue was available from 146 of these patients and from another 890 DBCG82bc patients .


Estrogen receptor , progesterone receptor , HER2 , CK5/6 , Ki-67 and EGFR were combined into immunohistochemical approximations of the intrinsic subtypes .


Endpoint considered was loco-regional recurrence ( LRR ) .


The DBCG-RT profile identified a group of patients with low risk of LRR and no additional benefit from PMRT among all subtypes .


Combining six immunohistochemical markers identified a subgroup of triple negative patients with high risk of LRR and significant benefit from PMRT .


Agreement in the different assignments of tumors to the subtypes was suboptimal , and the clinical outcome and predicted benefit from PMRT varied according to the method used for assignment .


The prognostic and predictive information obtained from the DBCG-RT profile can not be substituted by any approximation of the tumors intrinsic subtype .


The predictive value of the intrinsic subtypes in terms of PMRT was influenced by the method used for assignment to the intrinsic subtypes .


Investigate the effect of ankle taping on plantar-flexion strength , angle matching and force matching .


Single group , repeated measures .


Laboratory of an educational institution .


Twenty uninjured females ( 22.93.6 years ) .


Tape was applied to the ankle using a conventional hindfoot technique .


Angle and force matching , and plantar-flexor strength were assessed using the purpose built dual ankle dynamometer , and measures were taken prior to and following taping .


Angle matching was assessed passively and actively at 10 , 15 and 20 of plantar-flexion .


Participants were required to match the angle of the reference leg with the contralateral leg .


Force matching was assessed at 10 of plantar-flexion and participants matched the torque of the reference leg with the contralateral leg .


Taping had no effect on absolute errors during active or passive angle matching .


Regardless of taping , the ankle angle tested had a significant effect on passive angle matching ( p < 0.001 ) ; subjects were most accurate at matching a plantar-flexion angle of 20 .


Ankle taping had no effect on force matching .


Taping significantly improved peak plantar-flexion strength by 20 % ( p = 0.028 ) .


Ankle taping has little effect on contralateral force and angle matching , but it can enhance peak plantar-flexion strength .


Dexmedetomidine , a potent selective 2-adrenergic agonist , produces sedation and analgesia .


This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements , recovery profiles , and emergence agitation in children undergoing ambulatory surgery .


Forty children undergoing ambulatory hernioplasty or orchiopexy were randomized into two groups .


The dexmedetomidine group ( Group D , n = 20 ) received dexmedetomidine 1 g/kg , followed by 0.1 g/kg/h until the end of surgery , whereas the saline group ( Group S , n = 20 ) received volume-matched normal saline .


Sevoflurane was used for induction and maintenance of anesthesia and caudal block was performed in all children .


End-tidal sevoflurane concentration ( ET-sevo ) , the incidence of emergence agitation , pain scores , and sedation scores were recorded .


Hemodynamic changes and other adverse effects were assessed in the perioperative period .


ET-sevo of Group D was significantly reduced in 23.8-67 % compared to Group S during surgery .


The incidence of emergence agitation was lower in Group D than in Group S ( 5 % vs. 55 % , p = 0.001 ) .


Postoperative pain was comparable , and discharge time was not different between the groups .


Mean arterial pressure and heart rate were significantly lower in Group D during surgery .


Intraoperative infusion of dexmedetomidine reduced sevoflurane requirements and decreased emergence agitation without delaying discharge in children undergoing ambulatory surgery .


However , caution should be taken in regard to bradycardia and hypotension .


To investigate the effects of oxytocin on high-intensity focused ultrasound ( HIFU ) ablation for the treatment of adenomyosis .


Eighty-six patients with adenomyosis from three hospitals were randomly assigned to the oxytocin group or control group for HIFU treatment .


During HIFU treatment , 80 units of oxytocin was added in 500ml of 0.9 % normal saline running at the rate of 2ml/min ( 0.32 U/min ) in the oxytocin group , while 0.9 % normal saline was used in the control group .


Both patients and HIFU operators were blinded to oxytocin or saline application .


Treatment results , adverse effects were compared .


When using oxytocin , the non-perfused volume ( NPV ) ratio was 80.711.6 % , the energy-efficiency factor ( EEF ) was 8.19.9 J/mm ( 3 ) , and the sonication time required to ablate 1cm ( 3 ) was 30.036.0 s/cm ( 3 ) .


When not using oxytocin , the non-perfused volume ratio was 70.816.7 % , the EEF was 15.819.6 J/mm ( 3 ) , and the sonication time required to ablate 1cm ( 3 ) was 58.272.7 S/cm ( 3 ) .


Significant difference in the NPV ratio , EEF , and the sonication time required to ablate 1cm ( 3 ) between the two groups was observed .


No oxytocin related adverse effects occurred .


Oxytocin could significantly decrease the energy for ablating adenomyosis with HIFU , safely enhance the treatment efficiency .


To assess agreement between meter and diary self monitoring of blood glucose ( SMBG ) records , over a year , in a sample of patients with type 2 diabetes .


Meter and diary records were available , for 95 individuals , who took part in the Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes study .


Pearson 's correlation coefficient was used to explore the relationships between the types of error .


Maximum likelihood estimation was used to explore changes over time through a structural equation modelling approach .


Paired samples t-tests were used to determine if the presence of errors led to a significant difference between the mean diary and meter SMBG concentrations or coefficients of variation .


Multiple regression was used to explore possible predictors of the error indices .


Mean over-reporting , under-reporting , concordance and overall reliability were 8.4 % , 10.0 % , 83.5 % and 71.3 % , respectively .


The first week of monitoring had significantly more under-reporting , over-reporting and less concordance and overall reliability than subsequent weeks .


The majority of concordance errors were not clinically significant .


Those that were , tended to occur during the first three months of monitoring .


Participants ' at one trial site were significantly more likely to have recording errors than those at the largest site .


Error levels were similar to those described previously in type 1 diabetes and there was a suggestion of an initial learning curve for record keeping .


For some individuals diary records would not be considered acceptable if held to the same standards as blood glucose meters .


Secukinumab , a fully human anti-interleukin-17A monoclonal antibody , demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection .


Self-administration by pre-filled syringe ( PFS ) can offer patients clinical benefits of a drug , with increased convenience .


To assess efficacy , safety and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis .


Subjects in this phase 3 trial were randomized 1:1:1 to secukinumab 300 or 150mg or matching placebo .


Results to week 12 are presented here .


Each treatment was delivered using a PFS once weekly to week 4 , and again at week 8 .


Co-primary endpoints were secukinumab superiority over placebo for week 12 PASI 75 ( 75 % reduction in Psoriasis Area and Severity Index ) and IGA mod 2011 ( 2011 modified Investigator 's Global Assessment ) 0/1 response rates .


Secondary endpoints included PFS usability , determined by observer rating of successful , hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire ( SIAQ ) .


Co-primary endpoints were met , with demonstration of superiority for each secukinumab dose vs. placebo at week 12 ( PASI 75 : 759 % , 695 % and 0 % for secukinumab 300mg , 150mg and placebo ; IGA mod 2011 0/1 : 690 % , 525 % and 0 % , respectively ; P < 00001 for all comparisons vs. placebo ) .


PFS usability was high : 100 % of subjects successfully self-administered treatment at week 1 , and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial .


No new/unexpected safety signals were observed .


Secukinumab administration by PFS was effective , with an acceptable safety profile and high usability .


The PFS provides a reliable , convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis .


Exercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease .


Despite the benefits associated with regular exercise , adherence with supervised exercise-based cardiac rehabilitation remains low .


Increasingly powerful mobile technologies , such as smartphones and wireless physiological sensors , may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease .


This study compares the effectiveness of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( REMOTE ) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease .


A two-arm , parallel , non-inferiority , randomised controlled trial will be conducted at two sites in New Zealand .


One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted , home-based , remote monitored exercise-based cardiac rehabilitation ( intervention ) , or an 8-12 program of standard supervised exercise-based cardiac rehabilitation ( control ) .


The primary outcome is post-treatment maximal oxygen uptake ( VO2max ) .


Secondary outcomes include cardiovascular risk factors ( blood lipid and glucose concentrations , blood pressure , anthropometry ) , self-efficacy , intentions and motivation to be active , objectively measured physical activity , self-reported leisure time exercise and health-related quality of life .


Cost information will also be collected to compare the two modes of delivery .


All outcomes are assessed at baseline , post-treatment , and 6 months , except for VO2max , blood lipid and glucose concentrations , which are assessed at baseline and post-treatment only .


This novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach .


If the REMOTE program proves to be as effective as traditional cardiac rehabilitation , it has potential to augment current practice by increasing access for those who can not utilise existing services .


Australian New Zealand Clinical Trials RegistryStudy ID number : ACTRN12614000843651 .


Registered 7 August 2014 .


Acute pain after open abdominal hysterectomy limits the function of patients in the postoperative period , but data regarding the analgesic efficacy of a low dose of pregabalin ( 75 or 150 mg ) have been conflicting .


This study was performed to determine if a low dose of pregabalin could decrease postoperative opioid use following abdominal hysterectomy when compared with placebo .


American Society of Anesthesiologists I-II patients older than 18 yr and scheduled for open elective abdominal hysterectomy were recruited for participation and randomized to one of three groups : pregabalin 75 mg ( P75 ) , pregabalin 150 mg ( P150 ) , or placebo .


The study drug was administered two hours prior to surgery and 12 hr following the initial dose .


Anesthetic technique and postoperative analgesia were standardized .


Postoperative pain was managed using patient-controlled analgesia with morphine .


Pain at rest and movement as well as nausea were assessed with an 11-point numeric rating scale .


One hundred and one patients were recruited , and 89 patients completed the study .


Mean ( SD ) cumulative morphine consumption at 24 hr postoperatively was 54.0 ( 26.2 ) mg for the placebo group , 53.1 ( 22.7 ) mg for the P75 group , and 44.3 ( 20.9 ) mg for the P150 group .


Independent Student 's t tests indicated no difference between the placebo group and either the P75 group ( 95 % confidence interval [ CI ] : -11.75 to 13.44 ; P = 0.8937 ) or the P150 group ( 95 % CI : -2.74 to 22.15 ; P = 0.1238 ) .


At the doses used in this study , pregabalin treatment may not be effective in reducing opioid use up to 24 hr postoperatively following abdominal hysterectomy .


This trial was registered at www.ClinicalTrials.gov : NCT00781131 .


To investigate the effect of workplace neck/shoulder strength training with and without regular supervision on neck/shoulder pain and headache among office workers .


A 20-week cluster randomized controlled trial among 351 office workers was randomized into three groups : two training groups with the same total amount of planned exercises three times per week ( 1 ) with supervision ( 3WS ) throughout the intervention period , ( 2 ) with minimal supervision ( 3MS ) only initially , and ( 3 ) a reference group ( REF ) .


Main outcome is self-reported pain intensity in neck and shoulder ( scale 0-9 ) and headache ( scale 0-10 ) .


Intention-to-treat analyses showed a significant decrease in neck pain intensity the last 7 days in 3MS compared with REF : -0.5 0.2 ( P < 0.02 ) and a tendency for 3WS versus REF : -0.4 0.2 ( P < 0.07 ) .


Intensity of headache the last month decreased in both training groups : 3WS versus REF : -1.1 0.2 ( P < 0.001 ) and 3MS versus REF : -1.1 0.2 ( P < 0.001 ) .


Additionally , days of headache decreased 1.0 0.5 in 3WS and 1.3 0.5 in 3MS versus REF .


There were no differences between the two training groups for any of the variables .


Neck/shoulder training at the workplace reduced neck pain and headache among office workers independently of the extent of supervision .


This finding has important practical implications for future workplace interventions .


Preclinical data indicate anti-invasive activity of APG101 , a CD95 ligand ( CD95L ) - binding fusion protein , in glioblastoma .


Patients ( N = 91 ) with glioblastoma at first or second progression were randomized 1:2 between second radiotherapy ( rRT ; 36 Gy ; five times 2 Gy per week ) or rRT + APG101 ( 400 mg weekly i.v. ) .


Patient characteristics [ N = 84 ( 26 patients rRT , 58 patients rRT + APG101 ) ] were balanced .


Progression-free survival at 6 months ( PFS-6 ) rates were 3.8 % [ 95 % confidence interval ( CI ) , 0.1-19 .6 ] for rRT and 20.7 % ( 95 % CI , 11.2-33 .4 ) for rRT + APG101 ( P = 0.048 ) .


Median PFS was 2.5 ( 95 % CI , 2.3-3 .8 ) months and 4.5 ( 95 % CI , 3.7-5 .4 ) months with a hazard ratio ( HR ) of 0.49 ( 95 % CI , 0.27-0 .88 ; P = 0.0162 ) adjusted for tumor size .


Cox regression analysis adjusted for tumor size revealed a HR of 0.60 ( 95 % CI , 0.36-1 .01 ; P = 0.0559 ) for rRT + APG101 for death of any cause .


Lower methylation levels at CpG2 in the CD95L promoter in the tumor conferred a stronger risk reduction ( HR , 0.19 ; 95 % CI , 0.06-0 .58 ) for treatment with APG101 , suggesting a potential biomarker .


CD95 pathway inhibition in combination with rRT is an innovative concept with clinical efficacy .


It warrants further clinical development .


CD95L promoter methylation in the tumor may be developed as a biomarker .


Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis , a common cause of pain and disability in older adults .


However , rigorous data are lacking regarding the effectiveness and safety of these injections .


In a double-blind , multisite trial , we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone .


The patients received one or two injections before the primary outcome evaluation , performed 6 weeks after randomization and the first injection .


The primary outcomes were the score on the Roland-Morris Disability Questionnaire ( RMDQ , in which scores range from 0 to 24 , with higher scores indicating greater physical disability ) and the rating of the intensity of leg pain ( on a scale from 0 to 10 , with 0 indicating no pain and 10 indicating `` pain as bad as you can imagine '' ) .


At 6 weeks , there were no significant between-group differences in the RMDQ score ( adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group , -1.0 points ; 95 % confidence interval [ CI ] , -2.1 to 0.1 ; P = 0.07 ) or the intensity of leg pain ( adjusted difference in the average treatment effect , -0.2 points ; 95 % CI , -0.8 to 0.4 ; P = 0.48 ) .


A prespecified secondary subgroup analysis with stratification according to type of injection ( interlaminar vs. transforaminal ) likewise showed no significant differences at 6 weeks .


In the treatment of lumbar spinal stenosis , epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone .


( Funded by the Agency for Healthcare Research and Quality ; ClinicalTrials.gov number , NCT01238536 . )


GC1113 , a hybrid Fc-fused erythropoietin , is a novel erythropoiesis-stimulating agent that is expected to have an extended duration of action .


The preclinical data showed that the hemoglobin increase lasted longer following GC1113 administration than it did following the administration of darbepoetin alfa ( NESP ) .


This study aimed to investigate the pharmacodynamic and pharmacokinetic characteristics and tolerability profiles of GC1113 in humans after single intravenous or subcutaneous administration and to compare the results with those for darbepoetin alfa .


A dose-block randomized , placebo - and active-controlled , dose-escalation phase I clinical trial was conducted in 96 healthy volunteers .


Blood samples were collected before and up to 672 h after drug administration and the serum erythropoietin concentration following the GC1113 or darbepoetin alfa administration was measured by an ELISA .


The reticulocyte counts were measured for pharmacodynamic assessments .


Pharmacokinetic and pharmacodynamic parameters were determined using non-compartmental methods .


The reticulocyte count-time profiles in the intravenous GC1113 3-5 g/kg groups were comparable with those of the darbepoetin alfa 30 g group .


After subcutaneous administration of GC1113 , reticulocyte count peaked later and decreased more slowly than it did following darbepoetin alfa administration .


GC1113 ( 0.3-5 g/kg intravenous , 1-8 g/kg subcutaneous ) was well-tolerated in the volunteers , and no immunogenicity was observed .


GC1113 was tolerated and effective in the studied dose range ; these findings could be applied to further clinical studies with patients .


To evaluate the efficacy and safety of antiretroviral simplification from a ritonavir-boosted protease inhibitor-based regimen [ protease inhibitor + RTV + two nucleos ( t ) ide reverse transcriptase inhibitors ( NRTIs ) ; 6 months of exposure prior to study entry with no prior treatment failure ] to the single-tablet regimen ( STR ) rilpivirine/emtricitabine/tenofovir disoproxil fumarate ( RPV/FTC/TDF ) in virologically suppressed , HIV-1-infected participants .


Phase 3b , randomized , open-label , international , 48-week switch study .


Participants were randomized 2:1 to switch to RPV/FTC/TDF immediately or stay on their baseline protease inhibitor + RTV +2 NRTIs regimen with a delayed switch to RPV/FTC/TDF at week 24 .


The primary endpoint was noninferiority ( 12 % margin ) of RPV/FTC/TDF compared with protease inhibitor + RTV + two NRTIs in maintaining plasma HIV-1 RNA less than 50copies/ml at week 24 by Snapshot analysis .


A total of 476 participants were randomized and received at least one dose of study drug .


Demographics and baseline characteristics were similar between arms .


The primary objective of noninferiority at week 24 was met : HIV-1 RNA less than 50copies/ml by Snapshot analysis , 93.7 % of RPV/FTC/TDF versus 89.9 % of protease inhibitor + RTV + two NRTIs ( difference 3.8 % , 95 % confidence interval -1.6 to 9.1 % ) .


Through week 48 , 89.3 % of participants in the immediate switch group maintained virologic suppression .


High rates of suppression were maintained with RPV/FTC/TDF regardless of participant 's pre-antiretroviral HIV-1 RNA level .


Overall development of resistance mutations after switching to RPV/FTC/TDF was low .


Decreases in total cholesterol , low-density lipoprotein ( LDL ) , and triglycerides were significantly greater among RPV/FTC/TDF recipients than those in the protease inhibitor + RTV + two NRTIs group .


Switching to the STR RPV/FTC/TDF from an RTV-boosted protease inhibitor regimen in virologically suppressed , HIV-1-infected participants maintained virologic suppression with a low risk of virologic failure , while improving total cholesterol , LDL , and triglycerides .


Chronic pain caused by myofascial pain syndrome ( MPS ) results in generalized and debilitating conditions .


Trigger-point injection ( TPI ) is the mainstay of MPS management to reduce acute and localized pain .


Other adjunctive intervention to modulate the central pain pathway might be helpful if they are combined with TPI .


Transcranial direct-current stimulation ( tDCS ) , which is a form of neurostimulation , has been reported to be safe and effective in treating chronic pain by changing cortical excitability .


To determine whether there is an additional effect of tDCS and TPI to reduce pain in patients with MPS .


Twenty-one patients with newly diagnosed MPS of shoulder girdle muscles .


Patients were randomly assigned into 1 of 3 groups ( 2 active and 1 sham stimulation groups ) and received TPI .


Immediately after TPI , tDCS ( 2 mA for 20 minutes on 5 consecutive days ) was administered .


For the active stimulation groups , tDCS was applied over 2 different locations ( primary motor cortex and dorsolateral prefrontal cortex [ DLPFC ] ) .


Visual analogue scale ( VAS ) , Pain Threshold Test , and short form of the McGill Pain Questionnaire were measured before and immediately after stimulation for 5 consecutive days .


The mean VAS values were decreased in all three groups after 5 days .


There was a significant change between before and after stimulation only in the DLPFC group .


The significant change in the mean VAS value was shown from after the second stimulation session ( p = 0.031 ) , and this remained significant until the last stimulation session ( p = 0.027 ) .


This study suggests that tDCS over DLPFC may have additional effects with TPI to reduce pain in patients with MPS .


tDCS over DLPFC can be used to reverse central pain pathway by modulating cortical plasticity .


Docetaxel or AA are therapeutic options for mCRPC .


We retrospectively analyzed clinical outcomes with subsequent docetaxel in patients with mCRPC after disease progression ( DP ) with AA to evaluate cross resistance between these therapies .


Patients with chemotherapy-naive mCRPC who were treated with AA in previously reported phase I to III trials , who had DP , and were subsequently treated ( not on study ) with docetaxel , were included .


Acquired AA resistance was defined as : PSA decline > 50 % from baseline or radiographically stable disease for 8 months , with subsequent DP .


All other patients were defined as having primary AA resistance .


Efficacy outcomes after docetaxel therapy were analyzed .


We identified 23 patients who were treated with docetaxel after DP with AA , including 14 ( 61 % ) with acquired and 9 ( 39 % ) with primary AA resistance .


Median duration between discontinuation of AA and docetaxel initiation was 2.7 months ( range , 0.2-14 .7 months ) .


Subsequent docetaxel therapy led to 30 % PSA decline in 15 patients ( 65 % ) and 50 % PSA decline in 11 patients ( 48 % ) .


Median OS from date of first docetaxel dose was 12.4 months ( 95 % confidence interval , 8.2-19 .6 ) .


Patients with previous primary versus acquired AA resistance had similar outcomes with subsequent docetaxel therapy .


In this retrospective analysis , the type of AA resistance did not appear to affect outcomes with subsequent docetaxel .


The PSA response rates observed suggest a lack of cross-resistance between docetaxel and AA , but prospective studies are needed to evaluate for potential cross-resistance and optimize sequences of therapy in patients with mCRPC .


Interferon-containing regimens for the treatment of hepatitis C virus ( HCV ) infection are associated with increased toxic effects in patients who also have cirrhosis .


We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450 / r ) , the NS5A inhibitor ombitasvir ( ABT-267 ) , the nonnucleoside polymerase inhibitor dasabuvir ( ABT-333 ) , and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis .


We randomly assigned 380 patients with Child-Pugh class A cirrhosis to receive either 12 or 24 weeks of treatment with ABT-450 / r-ombitasvir ( at a once-daily dose of 150 mg of ABT-450 , 100 mg of ritonavir , and 25 mg of ombitasvir ) , dasabuvir ( 250 mg twice daily ) , and ribavirin administered according to body weight .


The primary efficacy end point was a sustained virologic response 12 weeks after the end of treatment .


The rate of sustained virologic response in each group was compared with the estimated rate with a telaprevir-based regimen ( 47 % ; 95 % confidence interval [ CI ] , 41 to 54 ) .


A noninferiority margin of 10.5 percentage points established 43 % as the noninferiority threshold ; the superiority threshold was 54 % .


A total of 191 of 208 patients who received 12 weeks of treatment had a sustained virologic response at post-treatment week 12 , for a rate of 91.8 % ( 97.5 % CI , 87.6 to 96.1 ) .


A total of 165 of 172 patients who received 24 weeks of treatment had a sustained virologic response at post-treatment week 12 , for a rate of 95.9 % ( 97.5 % CI , 92.6 to 99.3 ) .


These rates were superior to the historical control rate .


The three most common adverse events were fatigue ( in 32.7 % of patients in the 12-week group and 46.5 % of patients in the 24-week group ) , headache ( in 27.9 % and 30.8 % , respectively ) , and nausea ( in 17.8 % and 20.3 % , respectively ) .


The hemoglobin level was less than 10 g per deciliter in 7.2 % and 11.0 % of patients in the respective groups .


Overall , 2.1 % of patients discontinued treatment owing to adverse events .


In this phase 3 trial of an oral , interferon-free regimen evaluated exclusively in patients with HCV genotype 1 infection and cirrhosis , multitargeted therapy with the use of three new antiviral agents and ribavirin resulted in high rates of sustained virologic response .


Drug discontinuations due to adverse events were infrequent .


( Funded by AbbVie ; TURQUOISE-II ClinicalTrials.gov number , NCT01704755 . )


The role played by T helper cytokines under chronic , low grade inflammation as seen in type-2 Diabetes Mellitus ( T2DM ) and Coronary Artery Disease ( CAD ) co-morbidity is less well studied .


In the present study , we measured the serum levels of both Th1 and Th2 cytokines and correlated it with clinical risk factors for T2DM ( Insulin Resistance ( IR ) , Glycated haemoglobin ( HbA1c ) ) and CAD ( C-Reactive Protein ( CRP ) , Intima Media Thickness ( IMT ) and Augmentation index ( AGI ) ) in T2DM subjects with/without CAD .


The study subjects were recruited from Chennai Urban Rural Epidemiology Study ( CURES ) .


Serum cytokine profile was determined by multiplex cytokine assay in Control ( n = 61 ) , T2DM ( n = 60 ) , CAD ( n = 23 ) and T2DM-CAD ( n = 21 ) subjects .


T2DM subjects showed a mixed Th1-Th2 profile .


CAD subjects presented a Th1 profile with modest Th2 suppression while T2DM-CAD subjects showed enhanced Th1 profile with strong suppression of Th2 cytokines .


Both Th1 and Th2 cytokines showed a positive correlation with FPG , HbA1c , hsCRP , IMT and AGI .


Logistic regression analysis revealed a significant association of IL-12 ( OR = 9.3 ; 95 % CI = 3.2-70 .7 ; p = 0.016 ) , IFN - ( OR = 2.8 ; 95 % CI = 2.7-2 .9 , p = 0.010 ) , IL-4 ( OR = 2.7 ; 95 % CI 2.7-2 .7 , p = 0.010 ) , IL-5 ( OR = 1.1 ; 95 % CI = 1.0-1 .4 ; p = 0.003 ) and IL-13 ( OR = 2 ; 95 % CI = 1.7-2 .6 ; p = 0.017 ) with T2DM-CAD .


In conclusion , from the present study it appears that transition from T2DM or CAD to T2DM-CAD co-morbidity is associated with strong down regulation of Th2 cytokines and enhancement of Th1 responses .


We aimed to investigate the effects of metoclopramide and ondansetrone on mivacurium neuromuscular blockade .


Seventy five , ASA I-II patients , aged 18-65 and scheduled for elective surgery requiring tracheal intubation were included in the study .


The patients received metoclopramide 10 mg , ondansetrone 4 mg or normal saline 5 mL ; group M , group O , group NS ( n = 25 ) , respectively .


Before anesthesia study drugs were administered in a volume of 5 mL .


The level of plasma cholinesterase were obtained before and 5 minutes after the administration of study drugs and 5 minutes after the administration of mivacurium .


Onset time , T25 , T75 , T25-75 , T90 levels were compared with each other and differences between each patients were investigated .


After recording T90 , the study was terminated and surgery was started .


Onset time was significantly shorter in group M , than the other two groups .


Onset time in group O was significantly shorter than in group NS .


In Group M T25 , T75 , T90 and recovery indices were significantly greater than in Group NS ( p < 0.001 ) .


In Group O T25 , T75 were greater than Group NS ( p < 0.01 and p < 0.05 , respectively ) .


In Group M T75 , T90 and emergence indices were significantly higher than Group O ( p < 0.001 , p < 0.01 , p < 0.001 , respectively ) .


In Groups M and O , plasma cholinesterase levels decreased significantly ( p < 0.001 ) after administration of study drugs and mivacurium .


Plasma cholinesterase also was reduced in Group NS 5 minutes after the administration of mivacurium ( p < 0.001 ) .


Ondansetrone is believed to be more reliable agent than metoclopramide when used with mivacurium .