To investigate the effect of different heat-stimulating time lengths on lower back pain .


Forty participants were randomly assigned to four groups of various heating time lengths .


The short heating time length group ( SL ) , moderate heating time length group ( ML ) , and long heating time length group ( LL ) respectively received @ , @ , and @ min of moxibustion therapy stimulating the acupoint Guanyuan ( CV @ ) .


The conventional acupuncture group ( CA ) received needle acupuncture treatment as a control group .


The participants were treated continuously over a @-week treatment period for a total of @ sessions , with five sessions given per week .


Participants were assessed weekly by blinded assessors , using the visual analogue scale ( VAS ) and Roland Morris Questionnaire ( RMQ ) .


The VAS and RMQ scores reduced in all four groups during treatment .


There were significant differences in VAS scores ( P < @ ) and RMQ scores ( P < @ ) between before treatment and after @ weeks of treatment in the LL group .


After treatment , the LL group reported significantly lower VAS scores compared with the CA group , ML group , and SL group ( P < @ ) .


The long and moderate lengths of heat-stimulating time of @ and @ min may be more effective for relieving lower back pain than that of short stimulating time lengths .


In a recent phase II study of onartuzumab ( MetMAb ) , patients whose non-small cell lung cancer ( NSCLC ) tissue scored as positive for MET protein by immunohistochemistry ( IHC ) experienced a significant benefit with onartuzumab plus erlotinib ( O+E ) versus erlotinib .


We describe development and validation of a standardized MET IHC assay and , retrospectively , evaluate multiple biomarkers as predictors of patient benefit .


Biomarkers related to MET and/or EGF receptor ( EGFR ) signaling were measured by IHC , FISH , quantitative reverse transcription PCR , mutation detection techniques , and ELISA .


A positive correlation between IHC , Western blotting , and MET mRNA expression was observed in NSCLC cell lines/tissues .


An IHC scoring system of MET expression taking proportional and intensity-based thresholds into consideration was applied in an analysis of the phase II study and resulted in the best differentiation of outcomes .


Further analyses revealed a nonsignificant overall survival ( OS ) improvement with O+E in patients with high MET copy number ( mean@ copies/cell by FISH ) ; however , benefit was maintained in `` MET IHC-positive '' / MET FISH-negative patients ( HR , @ ; P = @ ) .


MET , EGFR , amphiregulin , epiregulin , or HGF mRNA expression did not predict a significant benefit with onartuzumab ; a nonsignificant OS improvement was observed in patients with high tumor MET mRNA levels ( HR , @ ; P = @ ) .


Patients with low baseline plasma hepatocyte growth factor ( HGF ) exhibited an HR for OS of @ ( P = @ ) in favor of onartuzumab treatment .


MET IHC remains the most robust predictor of OS and progression-free survival benefit from O+E relative to all examined exploratory markers .


Energy deficit ( ED ) diminishes fat-free mass ( FFM ) with concomitant reductions in anabolic hormone secretion .


A modest increase in protein to recommended dietary allowance ( RDA ) levels during ED minimally attenuates decrements in insulin-like growth factor-I ( IGF-I ) .


The impact of dietary protein above the RDA on circulating anabolic hormones and their relationships with FFM in response to ED are not well described .


Thirty-three adults were assigned diets providing protein at @ ( RDA ) , @ ( @-RDA ) , and @ ( @-RDA ) g/kg/d for @days .


Testosterone , sex-hormone binding globulin ( SHBG ) and IGF-I system components were assessed after a @-day period of weight-maintenance ( WM ) and after a @-day period of ED ( @ % ) achieved by an increase in energy expenditure and decreased energy intake .


Associations between the change in FFM and anabolic hormone levels were determined .


As compared to WM and regardless of dietary protein intake , total and free testosterone , total IGF-I , and acid-labile subunit decreased ( P < @ ) , whereas SHBG and IGF binding proteins-@ , -@ , and -@ increased ( P < @ ) during ED .


There were no energy-by-protein interactions on any hormones or IGF-I system components measured .


Changes in FFM in response to ED were negatively associated with acid-labile subunit ( ALS ) ( r = -@ , P < @ ) in @-RDA ; however , no other relationships were observed .


Consuming a high protein diet does not impact the androgenic and IGF-I system response to ED .


These data suggest that the protective effects of high protein diets on FFM during ED are likely not influenced by anabolic hormone concentrations .


After renal transplantation , postoperative pain is usually mild to moderate .


Postoperative pain is a concern and administration of systemic analgesic may be difficult because of underlying co-morbidities and variable responses of the graft .


The transversus abdominis plane ( TAP ) block is one of the different approaches for postoperative pain relief following abdominal surgeries .


We evaluated analgesic efficacy of TAP block on early postoperative pain by numeric rating scale ( NRS ) and morphine consumption during the first @ hours after kidney transplantation .


Forty-four patients , scheduled as kidney recipients were randomized into two equal groups and were anesthetized with the same technique .


After the induction of anesthesia , @mL of @ % Bupivacaine plus @/ml epinephrine or saline was deposited into the transversus abdominis neuro-fascial plane on the side of surgery by ultrasound guide .


Each patient was assessed by a blinded investigator using NRS at @st , @th , @th , @th , and @th hour postoperatively .


Demographic data were not significantly different between the study groups .


There was significant difference in median of NRS score measured at all time points in the study groups ( P < @ ) .


The @-hour morphine consumption ( meanSD ) was @ mg in bupivacaine group compared with @ mg in the saline group ( P = @ ) .


There was statistically significant reduction in intraoperative fentanyl consumption in the TAP group @g compared to the control group @g ( P = @ ) .


In study group @ patients and in control group @ patients received morphine titration for pain relief ( P = @ ) .


There was no complication in the study groups related to nerve block .


Only two patients in saline group had nausea ( P = @ ) .


None of our patients received any other oral or IV rescue medication .


Ultrasound TAP block can reduce postrenal transplantation pain and the amount of opioids consumption intraoperatively and during the first @ hours after surgery in kidney recipients .


Elevated symmetric dimethylarginine ( SDMA ) has been shown to predict cardiovascular events and all cause mortality in diverse populations .


The potential role of SDMA as a risk marker in renal transplant recipients ( RTR ) has not been investigated .


We analyzed SDMA in the placebo arm of the Assessment of Lescol in Renal Transplantation study , a randomized controlled trial of fluvastatin in RTR .


Mean follow-up was @ years .


Patients were grouped into quartiles based on SDMA levels at study inclusion .


Relationships between SDMA and traditional risk factors for graft function and all-cause mortality were analyzed in @ RTR using univariate and multivariate survival analyses .


In univariate analysis , SDMA was significantly associated with renal graft loss , all-cause death , and major cardiovascular events .


After adjustment for established risk factors including estimated glomerular filtration rate , an elevated SDMA-level ( @th quartile , > @ mol/L ) was associated with renal graft loss ; hazard ratio ( HR ) , @ ; @ % confidence interval ( CI ) , @-@ @ ; P = @ , compared to the @st quartile .


Similarly , SDMA in the @th quartile was independently associated with all-cause mortality ( HR , @ ; @ % CI , @-@ @ ; P < @ ) , and there was a strong borderline significant trend for an association with cardiovascular mortality ( HR , @ ; @ % CI , @-@ @ ; P = @ ) .


In stable RTR , an elevated SDMA level is independently associated with increased risk of all-cause mortality and renal graft loss .


Medication-overuse headache ( MOH ) is common in the general population .


We investigated effectiveness of brief intervention ( BI ) for achieving drug withdrawal in primary care patients with MOH .


The study was double-blind , pragmatic and cluster-randomised controlled .


A total of @,@ patients ( age @-@ ) from @ general practitioners ( GPs ) were screened for MOH .


GPs defined clusters and were randomised to receive BI training ( @ GPs ) or to continue business as usual ( BAU ; @ GPs ) .


The Severity of Dependence Scale was applied as a part of the BI .


BI involved feedback about individual risk of MOH and how to reduce overuse .


Primary outcome measures were reduction in medication and headache days/month @ months after the intervention and were assessed by a blinded clinical investigator .


@ % responded to the postal screening questionnaire , and @ % screened positive for MOH .


A random selection of up to three patients with MOH from each GP were invited ( @ patients ) , @ patients were randomised and @ patients included into the study .


BI was significantly better than BAU for the primary outcomes ( p < @ ) .


Headache and medication days were reduced by @ and @ ( @ % CI @ to @ and @ to @ ) days/month in the BI compared with the BAU group .


Chronic headache resolved in @ % of the BI and @ % of the BAU group .


The BI method provides GPs with a simple and effective instrument that reduces medication-overuse and headache frequency in patients with MOH .


The aim of this study was to determine both the value of gadolinium-enhanced MRI in children with suspected acute appendicitis and the best sequences for detecting acute appendicitis , to thereby decrease imaging time .


This was a retrospective review of pediatric patients with suspected appendicitis who had undergone MRI at our institution between @ and @ after an indeterminate ultrasound examination .


MRI examinations included T@-weighted unenhanced and contrast-enhanced , T@-weighted , and balanced steady-state free precession ( SSFP ) sequences in axial and coronal planes .


Sequences were reviewed together and individually by five radiologists who were blinded to the final diagnosis .


Radiologists were asked to score their confidence of appendicitis diagnosis using a @-point scale .


The diagnostic performance of each MR sequence was obtained by comparing the mean area under the curve ( AUC ) using receiver operating characteristic ( ROC ) analysis .


A total of @ patients with clinically suspected appendicitis were included , of whom @ received a diagnosis of appendicitis .


The mean AUCs for reviewing all sequences together , contrast-enhanced sequences alone , T@-weighted sequences alone , and balanced SSFP alone were @ , @ , @ , and @ , respectively .


No significant difference was observed between reviewing all sequences together versus contrast-enhanced sequences alone ( p = @ ) and T@-weighted sequences alone ( p = @ ) .


A significant difference was observed between contrast-enhanced sequences and balanced SSFP ( p < @ ) .


Gadolinium-enhanced images and T@-weighted images are most helpful in the assessment of acute appendicitis in the pediatric population .


These findings have led to protocol modifications that have reduced imaging time .


There is an urgent need for more effective treatments for major depressive disorder ( MDD ) .


As understanding of the cognitive and affective neuroscience underlying psychiatric disorders expands , so do opportunities to develop interventions that capitalize on the capacity for brain plasticity .


Cognitive training is one such strategy .


In this article , we report a proof-of-concept study of a novel cognitive-emotional training exercise designed to enhance cognitive control for emotional information processing and targeting components of the neural networks that have been implicated in MDD .


Twenty-one participants with MDD in a current episode were randomly assigned to one of the two treatment conditions : @ participating in a cognitive-emotional training paradigm ( emotional faces memory task ( EFMT ) ) involving eight sessions over @ weeks , and @ participating in an active control condition ( control training , CT ) .


Assessments of MDD symptoms , negative affective bias in cognitive processing , and neurocognition ( attention and working memory ) were administered at baseline and after @ weeks .


Participants in the EFMT group exhibited a greater reduction in MDD symptoms compared to the CT group , and @ of the @ EFMT participants achieved clinical response ( @ % reduction in symptoms ) .


EFMT participants also exhibited changes in negative affective bias in the hypothesized direction whereas the CT participants did not .


Both groups exhibited similar , small improvements in attention and working memory .


Cognitive-emotional training may represent a feasible and effective intervention strategy for MDD .


This proof-of-concept study highlights the need for future studies to fully understand the effectiveness , and mechanisms of effect , of these training strategies .


Uncertainty exists regarding the optimal method to estimate glomerular filtration rate ( GFR ) for disease detection and monitoring .


Widely used GFR estimates have not been validated in British ethnic minority populations .


Iohexol measured GFR will be the reference against which each estimating equation will be compared .


The estimating equations will be based upon serum creatinine and/or cystatin C.


The eGFR-C study has @ components : @ ) A prospective longitudinal cohort study of @ adults with stage @ chronic kidney disease followed for @ years with reference ( measured ) GFR and test ( estimated GFR -LSB- eGFR -RSB- and urinary albumin-to-creatinine ratio ) measurements at baseline and @ years .


Test measurements will also be undertaken every @ months .


The study population will include a representative sample of South-Asians and African-Caribbeans .


People with diabetes and proteinuria ( ACR @ mg/mmol ) will comprise @-@ % of the study cohort @ ) A sub-study of patterns of disease progression of @ people ( @ each of Caucasian , Asian and African-Caribbean origin ; in each case containing subjects at high and low risk of renal progression ) .


Additional reference GFR measurements will be undertaken after @ and @ years to enable a model of disease progression and error to be built @ ) A biological variability study to establish reference change values for reference and test measures @ ) A modelling study of the performance of monitoring strategies on detecting progression , utilising estimates of accuracy , patterns of disease progression and estimates of measurement error from studies @ ) , @ ) and @ ) @ ) A comprehensive cost database for each diagnostic approach will be developed to enable cost-effectiveness modelling of the optimal strategy.The performance of the estimating equations will be evaluated by assessing bias , precision and accuracy .


Data will be modelled as a linear function of time utilising all available ( maximum @ ) time points compared with the difference between baseline and final reference values .


The percentage of participants demonstrating large error with the respective estimating equations will be compared .


Predictive value of GFR estimates and albumin-to-creatinine ratio will be compared amongst subjects that do or do not show progressive kidney function decline .


The eGFR-C study will provide evidence to inform the optimal GFR estimate to be used in clinical practice .


Cardiovascular disease ( CVD ) accounts for @ % of UK deaths .


It is associated with modifiable lifestyle factors , including insufficient consumption of fruit and vegetables ( F&V ) .


Lay health trainers ( LHTs ) offer practical support to help people develop healthier behaviour and lifestyles .


Our two-group pilot randomized controlled trial ( RCT ) investigated the effectiveness of LHTs at promoting a heart-healthy lifestyle among adults with at least one risk factor for CVD to inform a full-scale RCT .


Eligible adults ( aged @-@ years ) , recruited from five practices serving deprived populations , were randomized to health information leaflets plus LHTs ' support for @ months ( n = @ ) versus health information leaflets alone ( n = @ ) .


We recruited @ participants , with @ % completing @ month follow-up .


Both groups increased their self-reported F&V consumption and we found no evidence for LHTs ' support having significant added impact .


Most participants were relatively less deprived , as were the LHTs we were able to recruit and train .


Our pilot demonstrated that an LHT 's RCT whilst feasible faces considerable challenges .


However , to justify growing investment in LHTs , any behaviour changes and sustained impact on those at greatest need should be demonstrated in an independently evaluated , robust , fully powered RCT .


To evaluate time-limited hydrotubation combined with clomiphene citrate as treatment for unexplained infertility .


In this unblinded , randomized controlled trial of patients who had unexplained infertility , @ patients were treated with time-limited hydrotubation ( saline , @ ml ; flushed within @ to @ seconds ) and clomphene citrate ( total , @ cycles ) and @ patients were treated with clomiphene citrate alone ( total , @ cycles ) .


All women underwent an ovulation induction protocol with clomiphene citrate ( @ mg/d orally for five days , from day @ to day @ of the cycle ) .


Hydrotubation was performed after detection of the dominant follicle .


There were @ pregnancies in the @ patients ( @ % ) ( total , @ stimulated cycles ; @ % pregnancies per cycle ) .


The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate ( nine pregnancies per cycle -LSB- @ % -RSB- ) than those treated with clomiphene citrate alone ( two pregnancies per cycle -LSB- @ % -RSB- ; odds ratio , @ ; @ % confidence interval , @ to @ ; p @ ) .


The frequency of pregnancy per patient ( total , clinical , or chemical ) was similar for the two treatment groups .


The frequency of live birth or abortion per cycle or patient was similar between the two treatment groups .


Time-limited hydrotubation and clomiphene citrate may increase the frequency of clinical pregnancy per cycle in women who have unexplained infertility .


Although colonoscopy is the standard procedure in the diagnosis of colorectal neoplasia , a significant number of clinical relevant lesions may be missed even by experienced endoscopists using current technology .


A transparent cap mounted at the tip of a colonoscope may be an easy way to extend the visual field during colonoscopy and may improve the detection rate of mucosal lesions .


The significance of cap assisted ( CAC ) vs. conventional colonoscopy ( CC ) on polyp detection rate was evaluated in a prospective randomized controlled trial in @ patients .


CC and CAC detected polyps in @ % and @ , not significantly different .


There was also no significant difference between CAC and CC according to age , sex , indication for colonoscopy , diverticulosis , sedation , bowel cleansing , withdrawal time , time/number of attempts to intubate the cecal walve , number , localization , size or histology of polyps , .


However , the time to reach the cecal floor and the overall time of colonoscopy were significantly lower for CAC ( @ minute ) .


CAC was without clinical impact on polyp detection rate or performance of colonoscopy .


Although most intensive care unit ( ICU ) admissions originate in the emergency department ( ED ) , a substantial number of admissions arrive from hospital wards .


Patients transferred from the hospital ward often share clinical characteristics with those admitted from the ED , but family expectations may differ .


An understanding of the impact of ICU admission source on family perceptions of end-of-life care may help improve patient and family outcomes by identifying those at risk for poor outcomes .


This was a cohort study of patients with chronic illness and acute respiratory failure requiring mechanical ventilation who died after admission to an ICU in any of the @ participating hospitals in the Seattle-Tacoma area between @ and @ ( n = @,@ ) .


Using regression models adjusted for hospital site and patient - , nurse - and family-level characteristics , we examined associations between ICU admission source ( hospital ward vs. ED ) and ( @ ) family ratings of satisfaction with ICU care ; ( @ ) family and nurse ratings of quality of dying ; ( @ ) chart-based indicators of palliative care .


Admission from the hospital ward was associated with lower family ratings of quality of dying -LSB- -@ , @ % confidence interval ( CI ) -@ , -@ , p = @ -RSB- and satisfaction ( total score -@ , @ % CI -@ , -@ , p = @ ; satisfaction with care domain score -@ , @ % CI -@ , -@ , p = @ ) .


Nurses did not report differences in quality of dying .


Patients from hospital wards were less likely to have family conferences -LSB- odds ratio ( OR ) @ , @ % CI @ , @ , p = @ -RSB- or discussion of prognosis in the first @ h after ICU admission ( OR @ , @ % CI @ , @ , p = @ ) but were more likely to receive spiritual care ( OR @ , @ % CI @ , @ , p = @ ) or have life support withdrawn ( OR @ , @ % CI @ , @ , p = @ ) .


Admission from the hospital ward is associated with family perceptions of a lower quality of dying and less satisfaction with ICU care .


Differences in receipt of palliative care suggest that family of patients from the hospital ward receive less communication .


Nurse ratings of quality of dying did not significantly differ by ICU admission source , suggesting dissimilarities between family and nurse perspectives .


This study identifies a patient population at risk for poor quality palliative and end-of-life care .


Future studies are needed to identify interventions to improve care for patients who deteriorate on the wards following hospital admission .


Hypericum perforatum ( St John 's wort ) is used to treat depression , but the effectiveness has not been established .


Recent guidelines described the analysis of clinical trials with missing data , inspiring the reanalysis of this trial using proper missing data methods .


The objective was to determine whether hypericum was superior to placebo in treating major depression .


A placebo-controlled , randomized clinical trial was conducted for @ weeks to determine the effectiveness of hypericum or sertraline in reducing depression , measured using the Hamilton depression scale.We performed sensitivity analyses under different assumptions about the missing data process .


Three hundred forty participants were randomized , with @ % lost to follow-up .


The missing data mechanism was not missing completely at random .


Under missing at random assumptions , some sensitivity analyses found no difference between either treatment armand placebo , while some sensitivity analyses found a significant difference from baseline to week @ between sertraline and placebo ( -@ , @ % credible interval -LSB- -@ ; -@ -RSB- ) , but not between hypericum and placebo ( @ , -LSB- -@ ; @ -RSB- ) .


The results were similar when the missing data process was assumed to be missing not at random .


There is no difference between hypericum and placebo , regardless of the assumption about the missing data process .


There is a significant difference between sertraline and placebo with some statistical-methods used .


It is important to conduct an analysis that takes account of missing data using valid statistically principled methods .


The assumptions about the missing data process could influence the results .


An important factor in the functional results after total knee arthroplasty is the achieved maximal flexion .


The main purpose of this study was to compare the maximal knee flexion one year after surgery in patients who received either the bicruciate substituting knee system or the conventional posterior stabilized system .


In a prospective randomized controlled trial , @ patients presenting with osteoarthritis received the bicruciate substituting or the conventional posterior stabilized prosthesis .


The primary outcome was the maximum flexion angle at one year postoperatively on a lateral radiograph made with the supine patient using manual force to bend the knee .


Secondary outcomes were active flexion ( lying and standing ) , the Knee Society Score , the Patella Scoring System score , the University of California Los Angeles score , the number and type of adverse device effects , and visual analog scale satisfaction up to two years postoperatively .


The outcome measures of both groups were compared using one-sided t tests and non-parametric alternatives , with a significance level of p < @ .


No significant differences between the two groups were observed in maximal flexion on radiographs and in active flexion at baseline .


The median maximal flexion on radiographs was @ ( range , @ to @ ) for the bicruciate substituting group and @ ( range , @ to @ ) for the conventional posterior stabilized group .


The two groups showed comparable two-year results with respect to the Knee Society Score , the Patella Scoring System , the University of California Los Angeles score , and visual analog scale satisfaction .


In the bicruciate substituting group , forty-one adverse device effects in twenty-six patients were reported , including three total system revisions and fourteen manipulations under anesthesia , compared with the conventional posterior stabilized group , in which sixteen adverse device effects were observed in thirteen patients , including six manipulations under anesthesia ( p = @ ) .


Patients who receive a bicruciate substituting system compared with those who receive a conventional posterior stabilized system have comparable knee flexion characteristics and clinical and functional outcomes but more complications by two years after total knee arthroplasty .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Angiotensin II receptor blockers ( ARBs ) is a well-tolerated class of antihypertensive agents , exhibiting effective antihypertensive and cardiovascular protective function .


The objective of the study was to examine the efficacy and safety of Allisartan Isoproxil , a newly developed , selective , nonpeptide blocker of the angiotensin II type @ receptor ( AT@R ) , in essential hypertensive patients at low-medium risk .


A Phase II prospective , randomized , double-blind , placebo-controlled , multicenter trial comparing Allisartan Isoproxil @mg versus placebo was conducted in essential hypertensive patients at low-medium risk at @ sites in China .


After a @-week placebo baseline period , @ patients received once-daily treatment with Allisartan Isoproxil @mg or placebo randomly for @ weeks .


Systolic/diastolic blood pressure ( SBP/DBP ) was measured at week @ , @ and @ .


By the end of treatment , mean reductions from baseline of SBP and DBP in Allisartan Isoproxil and placebo groups were @ / @ and @ / @ mmHg , respectively ( P < @ ) .


The rate of effective blood pressure control in Allisartan Isoproxil group was significantly higher than in placebo group at week @ ( @ % vs @ % , P < @ ) and week @ ( @ % vs @ % , P < @ ) .


In terms of safety and tolerability , there were no report of death and serious adverse event ( SAE ) in all subjects .


There was no difference of frequency between two groups in adverse event ( AE ) and adverse drug reaction ( ADR ) ( P > @ ) .


No one withdraw because of an ADR in two groups .


@ patients received additional @ weeks treatment with Allisartan Isoproxil and @ of them completed the study .


The rate of effective BP control kept up to @ % since week @ .


No significant clinical change was observed and ADRs were generally mild or moderate during the long-term study .


Allisartan Isoproxil @mg was effective and safe for essential hypertension patients at low-medium risk .


Bipolar I disorder ( BD-I ) is a chronic mental illness characterized by the presence of one or more manic episodes , or both depressive and manic episodes , usually separated by asymptomatic intervals .


Pharmacists can contribute to the management of BD-I , mainly with the use of effective and safe drugs , and improve the patient 's life quality through pharmaceutical care .


Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses ; however , to our knowledge , there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD .


The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I .


Randomized , controlled , prospective , single-center clinical trial with duration of @months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic .


Patients diagnosed with BD-I aged between @ and @years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic ( Antioquia , Colombia ) will be included .


Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists , or into the control group who will receive usual care and verbal-written counseling regarding BD .


Study outcomes will be assessed at baseline and at @ , @ , @ , and @months after randomization .


The primary outcome will be to measure the number of hospitalizations , emergency service consultations , and unscheduled outpatient visits .


Effectiveness , safety , adherence , and quality of life will be assessed as secondary outcomes .


Statistical analyses will be performed using two-tailed McNemar tests , Pearson chi-square tests , and Student 's t-tests ; a P value < @ will be considered as statistically significant .


As far as we know , this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals , solution of drug-related problems , and adherence .


The disease process leading to clinical type @ diabetes often starts during the first years of life .


Early exposure to complex dietary proteins may increase the risk of - cell autoimmunity in children at genetic risk for type @ diabetes .


Extensively hydrolyzed formulas do not contain intact proteins .


To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children .


A double-blind randomized clinical trial of @ infants with HLA-conferred disease susceptibility and a first-degree relative with type @ diabetes recruited from May @ to January @ in @ study centers in @ countries ; @ were randomized to be weaned to the extensively hydrolyzed casein formula and @ were randomized to be weaned to a conventional cows ' milk-based formula .


The participants were observed to April @ , @ .


The participants received either a casein hydrolysate or a conventional cows ' milk formula supplemented with @ % of the casein hydrolysate .


AND MEASURES : Primary outcome was positivity for at least @ diabetes-associated autoantibodies out of @ analyzed .


Autoantibodies to insulin , glutamic acid decarboxylase , and the insulinoma-associated-@ ( IA-@ ) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of @ years ( mean , @ years ) .


The absolute risk of positivity for @ or more islet autoantibodies was @ % among those randomized to the casein hydrolysate formula ( n = @ ) vs @ % among those randomized to the conventional formula ( n = @ ) .


The unadjusted hazard ratio for positivity for @ or more autoantibodies among those randomized to be weaned to the casein hydrolysate was @ ( @ % CI , @-@ @ ) , compared with those randomized to the conventional formula , while the hazard ratio adjusted for HLA risk , duration of breastfeeding , vitamin D use , study formula duration and consumption , and region was @ ( @ % CI , @-@ @ ) .


There were no clinically significant differences in the rate of reported adverse events between the @ groups .


Among infants at risk for type @ diabetes , the use of a hydrolyzed formula , when compared with a conventional formula , did not reduce the incidence of diabetes-associated autoantibodies after @ years .


These findings do not support a benefit from hydrolyzed formula .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


Postural control associated with self-paced movement is critical for balance in frail older adults .


The present work aimed to investigate the effects of a @D virtual reality-based program on postural control associated with rapid arm movement in this population .


Participants in an upright standing position performed rapid arm-raising movements towards a target .


Practice-related changes were assessed by pre - and post-test comparisons of hand kinematics and centre-of-pressure ( CoP ) displacement parameters measured in a training group and a control group .


During these pre - and post-test sessions , patients have to reach towards yellow balls appearing on the screen , form a standardized upright position ( with @cm between the two malleoli ) .


Training group patients took part in six sessions of virtual game .


In this , patients were asked to reach their arm towards yellow balls appearing on the screen , from an upright position .


After training , we observed improvements in arm movements and in the initial phase of CoP displacement , especially in the anticipatory postural adjustments .


Learning curves for these two types of motor improvements showed different rates .


These were continuous for the control of the arm movement , and discontinuous for the control of the CoP during the anticipatory postural adjustments .


These results suggest that some level of motor ( re ) - learning is maintained in frail patients with low functional reserves .


They also suggest that re-learning of anticipatory postural control ( i.e. motor prediction ) is less robust than explicit motor learning involved for the arm reaching .


This last point should encourage clinicians to extend the training course duration , even if reaching movement improvements seems acquired , in order to automate these anticipatory postural activities .


However , other studies should be done to measure the retention of these two types of learning on a longer-term period .


The hippocampal volume is reduced in patients with major depression .


Exercise leads to an increased hippocampal volume in schizophrenia and in healthy old adults .


The effect of exercise on hippocampal volume is potentially mediated by brain derived neurotrophic factor ( BDNF ) , vascular endothelial growth factor ( VEGF ) , and insulin like growth factor @ ( IGF-@ ) .


The aim of this trial was to assess the effect of an aerobic exercise intervention on hippocampal volume and serum BDNF , VEGF , and IGF-@ in patients with major depression .


Patients were randomized to an aerobic exercise intervention ( n = @ ) or a control condition ( n = @ ) .


Both interventions consisted of three supervised sessions per week during a three months period .


Post-intervention the increase in maximal oxygen uptake was @ ml/kg/min ( SD @ ) in the aerobic exercise group and @ ml/kg/min ( SD @ ) in the control group ( p = @ ) .


The hippocampal volume , BDNF , VEGF , or IGF-@ did not differ between the two groups .


Post-hoc we found a positive association between change in hippocampal volume and verbal memory ( Rho = @ ; p = @ ) and change in hippocampal volume and depressive symptoms ( Rho = @ ; p = @ ) .


Participation was low in both groups corresponding to an average participation of one session per week .


Despite a significant increase in maximal oxygen uptake , a pragmatic exercise intervention did not increase hippocampal volume or resting levels of neurotrophines in out-patients with mild to moderate major depression .


Trial identifier : ClinicalTrials.gov ( NCT@ ) .


Intra-lesional bony overgrowth ( BO ) identified during or following cartilage repair treatment is being frequently described through subjective reports focusing primarily on incidence .


Our objective was to quantify the exact volume of intra-lesional BO at @ months post-cartilage repair treatment , to determine if a correlation exists between the extent of BO and clinical outcomes , and to visualize and characterize the BO .


MRI scans were systematically obtained during a randomized clinical trial for cartilage repair ( Stanish etal. , @ ) that compared two microfracture-based treatments in @ patients .


Semi-automated morphological segmentation of pre-treatment , @ and @ months post-treatment scans utilizing a programmed anatomical atlas for all knee bone and cartilage structures permitted three-dimensional reconstruction , quantitative analysis , as well as qualitative characterization and artistic visualization ofBO .


Limited intra-lesional BO representing only @ % of the original debrided cartilage lesion volume was found in @ patients with available MRIs at @ months .


The majority ( @ % ) of patients had very little BO ( < @ % ) .


Most occurrences of BO carried either spotty ( @ % ) or planar ( @ % ) morphological features , and the remaining balance ( @ % ) was qualitatively unobservable by eye .


Pre-existing BO recurred at @ months in the same intra-lesional location in @ % of patients .


No statistical correlations were found between BO and clinical outcomes .


Intra-lesional BO following microfracture-based treatments may not be as severe as previously believed , its incidence is partly explained by pre-existing conditions , and no relationship to clinical outcomes exists at @ months .


Morphologically , observable BO was categorized as comprising either spotty or planar bone .


To evaluate the role of post-surgical medical treatment with GnRHa in patients with DIE ( Deep Infiltrating Endometriosis ) that received complete or incomplete surgery laparoscopic excision .


Hundred fifty-nine patients with deep infiltrating endometriosis of the cul-de-sac and of the rectovaginal septum with pelvic pain undergoing laparoscopic surgery in academic tertiary-care medical center .


Eighty patients underwent complete laparoscopic excision of DIE ( Arm A ) while @ patients underwent incomplete surgery ( Arm B ) .


After surgery each surgical arm was randomized in two groups : no treatment groups @A -LSB- @ pts -RSB- and @B -LSB- @ pts -RSB- and GnRHa treatment for @ months groups @A -LSB- @ pts -RSB- and @B -LSB- @ pts -RSB- .


Pain recurrence and quality of life were evaluated in follow-up of @ months and compared between groups .


No differences were observed between patient groups @A and @A .


Groups @A , @A and @B obtained significantly lower pain scores than those achieved by the group @B undergoing incomplete surgical treatment and no post-surgical therapy .


At @-year follow-up patients treated with en-block resection ( Groups @A and @A ) showed the lowest pain scores and the highest quality of life in comparison with the other two groups ( Group @B and @B ) .


GnRHa administration is followed by a temporary improvement of pain in patients with incomplete surgical treatment .


It seems that it has no role on post-surgical pain when the surgeon is able to completely excise DIE implants .


Diminished quality of life ( QOL ) is associated with major depressive disorder ( MDD ) .


QOL was assessed in a post-hoc analysis of a double-blind , placebo-controlled trial .


Employed adult outpatients with MDD were randomly assigned to @ weeks of treatment with desvenlafaxine @mg/d or placebo .


Changes from baseline in the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) item scores at week @ were analyzed using analysis of covariance with treatment , region , and baseline in the model .


Correlations between change from baseline in the @-item Hamilton Rating Scale for Depression ( HAM-D@ ) total score and Q-LES-Q scores were computed .


The intent-to-treat population included @ patients .


There were statistically significant improvements from baseline for desvenlafaxine vs placebo in @ of @ Q-LES-Q item scores ( P values @ ) .


The percentage of patients with severe QOL impairment ( @ SD below community norm ) at week @ was significantly lower for desvenlafaxine ( @ % ) vs placebo ( @ % ; P = @ ; baseline : @ % and @ % , respectively ) .


Change in Q-LES-Q total score was highly correlated with change in HAM-D@ score at week @ , LOCF ( P < @ ) , and improvement in HAM-D@ total score at week @ predicted change in Q-LES-Q total score at week @ for the desvenlafaxine group ( F = @ ; P < @ ) but not placebo .


This analysis excluded patients who were unemployed , had severe comorbidities , and those taking multiple , concomitant medications .


Improvement in QOL and depressive symptoms was significantly greater for employed depressed patients treated with desvenlafaxine vs placebo .


Although physical exercise improves motor aspects of Parkinson 's disease ( PD ) , it is not clear whether it may also have a neuroprotective effect .


Objective .


In this @-year follow-up study , we determined whether intensive exercise in the early stages of the disease slows down PD progression .


Forty newly diagnosed patients with PD were treated with rasagiline and randomly assigned to @ groups : MIRT Group ( two @-day multidisciplinary intensive rehabilitation treatments -LSB- MIRT -RSB- , at @-year interval ) and Control Group ( only drug ) .


In both groups , Unified Parkinson 's Disease Rating Scale Section II ( UPDRS II ) , UPDRS III , @-minute walking test ( @MWT ) , Timed Up-and-Go test ( TUG ) ; PD Disability Scale ( PDDS ) , and l-dopa equivalents were assessed at baseline ( T@ ) , @ months ( T@ ) , @ year ( T@ ) , @ months ( T@ ) , and @ years ( T@ ) later .


Over @ years , UPDRS II , UPDRS III , TUG , and PDDS differentially progressed in the @ groups : In the MIRT Group , all scores at T@ were better than at T@ ( all Ps < @ ) .


No changes were noted in the Control Group .


l-dopa equivalent dosages increased significantly only in the Control Group ( P = @ ) , with a decrease in the percentages of patients in monotherapy ( T@ @ % ; T@ , T@ , and T@ @ % ) .


In the MIRT Group , the percentages of such patients remained higher ( T@ and T@ @ % ; T@ @ % ; T@ @ % ) .


These results suggest that MIRT might slow down the progression of motor decay , it might delay the need for increasing drug treatment , and thus , it might have a neuroprotective effect .


The aim of the present study was to investigate whether the following four markers : vitamin B@ , selenium , vitamin D , and parvalbumin may be used as compliance markers for fish intake .


Blood samples from a randomized cross-over herring intervention study ( n = @ ) were analysed by HPLC and immunochemistry .


The criteria were that plasma or serum concentrations of candidate compliance markers after the herring diet should increase significantly compared to starting concentrations .


In addition , the reference meat diet should not yield an increase in plasma concentration of the candidate marker .


Vitamin B@ and selenium met the set criteria for indicating a correlation between the marker and fish intake with significant increases in serum concentrations at @ % ( p = @ ) and @ % ( p = @ ) , respectively , after a @-week herring intervention ( @ meals a week ) .


Parvalbumin and @-hydroxy vitamin D@ levels did not increase significantly after the herring interventions .


Vitamin B@ may be suitable as a compliance marker for fish intake .


Although selenium also met the criteria , the change in selenium serum concentrations was small compared to the change in vitamin B@ levels .


To evaluate peripheral nerve safety and clinical efficacy of tanezumab in patients with painful osteoarthritis .


Patients received intravenous tanezumab @mg , tanezumab @mg , or placebo every @ weeks for @ weeks .


Neurological safety was evaluated via a composite score ( nerve conduction attributes and heart rate variability with deep breathing ; @NC + HRdb ) , intraepidermal nerve fiber ( IENF ) density , and clinical assessments .


Efficacy and general safety were also evaluated .


The study was stopped prematurely by an FDA partial clinical hold ( joint safety issues in other studies ) .


Differences in change from baseline to Week @ in @NC + HRdb were not significant .


Tanezumab @mg vs placebo exceeded the prespecified clinically important difference using last observation carried forward imputation , but not with observed data or when patients with evidence of neuropathy at baseline were excluded .


No significant differences were found in individual nerve conduction measures .


No treatment exceeded the prespecified clinically important decrease in IENF .


Tanezumab resulted in significant improvement in pain , physical function , and Patient 's Global Assessment .


Safety was similar to previous tanezumab clinical trials .


Tanezumab has a modulating effect on pain , does not appear to increase neurological safety signals , and offers a potentially promising , novel approach in treatment of pain .


To evaluate the safety of the performance of the traditional and protected collection techniques of tracheal aspirate and to identify qualitative and quantitative agreement of the results of microbiological cultures between the techniques .


Clinical , prospective , comparative , single-blind research .


The sample was composed of @ patients of > @ years of age , undergoing invasive mechanical ventilation for a period of @ hours and with suspected Ventilator Associated Pneumonia .


The two techniques were implemented in the same patient , one immediately after the other , with an order of random execution , according to randomization by specialized software .


No significant events occurred oxygen desaturation , hemodynamic instability or tracheobronchial hemorrhage ( p < @ ) and , although there were differences in some strains , there was qualitative and quantitative agreement between the techniques ( p < @ ) .


Utilization of the protected technique provided no advantage over the traditional and execution of both techniques was safe for the patient .


The spot urine protein/creatinine ratio ( UPCR ) is proposed to be a substitute for @-hour urinary protein ( @h-UP ) .


This study is aimed to determine whether the predictive accuracy of @h-UP using UPCR can be improved by simply multiplying estimated daily urine creatinine excretion ( eUCr ) and UPCR together .


This study enrolled @ participants to investigate the correlation between spot UPCR and @h-UP .


Three sets of spot urine samples were randomly collected throughout the day and night , along with the first morning void .


UPCR was weighted by eUCr to investigate the improvement of accuracy in using spot urine samples to predict @h-UP .


There were strong correlation and concordance between UPCR and @h-UP irrespective of the time of spot urine sampling , and the correlation , concordance and agreement were improved after multiplying the UPCR value by the eUCr .


Greater improvement was found in the subgroups with measured daily urine creatinine excretion @ g/d and @ g/d .


This investigation demonstrated that multiplying UPCR by eUCr can improve the accuracy of only using UPCR to predict @h-UP .


Malignant pleural effusion is associated with short life expectancy and significant morbidity .


A randomized controlled trial comparing indwelling pleural catheters ( IPCs ) with talc pleurodesis found that IPCs reduced in-hospital time and the need for additional procedures but were associated with excess adverse events .


Using data from the clinical trial , we compared costs associated with use of IPCs and with talc pleurodesis .


Resource use and adverse events were captured through case report forms over the @-year trial follow-up .


Costs for outpatient and inpatient visits , diagnostic imaging , nursing , and doctor time were obtained from the UK National Health Service reference costs and University of Kent 's Unit Costs of Health and Social Care @ and inflated to @ using the UK Consumer Price Index .


Procedure supply costs were obtained from the manufacturer .


Difference in mean costs was compared using nonparametric bootstrapping .


All costs were converted to US dollars using the Organisation for Economic Co-operation and Development Purchasing Power Parity Index .


Overall mean cost ( SD ) for managing patients with IPCs and talc pleurodesis was $ @,@ ( $ @,@ ) and $ @,@ ( $ @,@ ) , respectively .


The incremental mean cost difference was $ @ , with @ % CI of - $ @,@ to $ @,@ .


The mean cost related to ongoing drainage in the IPC group was $ @,@ ( $ @ ) vs $ @ ( $ @ ) in the talc pleurodesis group ( P = @ ) .


This included the cost of drainage bottles , dressing changes in the first month , and catheter removal .


There was no significant difference in cost of the initial intervention or adverse events between the groups .


For patients with survival < @ weeks , IPC is significantly less costly than talc pleurodesis , with mean cost difference of - $ @,@ ( @ % CI , - $ @,@ to - $ @ ) .


There is no significant difference in the mean cost of managing patients with IPCs compared with talc pleurodesis .


For patients with limited survival , IPC appears less costly .


In pulmonary arterial hypertension ( PAH ) , adding oral sildenafil to intravenous epoprostenol improved @-minute walk distance ( @MWD ) and hemodynamics and delayed time to clinical worsening in a @-week randomized , placebo-controlled trial ( Pulmonary Arterial Hypertension Combination Study of Epoprostenol and Sildenafil -LSB- PACES-@ -RSB- ) .


Patients completing PACES-@ could receive sildenafil ( titrated to @ mg , three times daily , as tolerated ) in an open-label extension study ( PACES-@ ) for @ years ; additional therapy was added according to investigator judgment .


Survival and changes from PACES-@ baseline in World Health Organization Functional Class and @MWD were captured .


In an open-label setting , @MWD , an effort-dependent outcome measure , was known to have improved or to have been maintained in @ % , @ % , and @ % of patients at @ , @ , and @ years , respectively ; functional class was known to have improved or to have been maintained in @ % , @ % , and @ % .


At @ years , @ % of patients were known to be alive , @ % were known to have died , and @ % were lost to follow-up .


Patients with PACES-@ baseline @MWD < @ meters without @MWD improvement during the first @ weeks of sildenafil treatment subsequently had poorer survival .


Although reliable assessments of safety and efficacy require a long-term randomized trial , the addition of sildenafil to background intravenous epoprostenol therapy appeared generally to be well tolerated in PAH patients .


Erlotinib , N - ( @-ethynylphenyl ) -@,@ - bis ( @-methoxyethoxy ) quinazolin-@-amine is approved for the treatment for non-small cell lung cancer and pancreatic cancer .


Because erlotinib is metabolized predominately by CYP@A@ , co-administration of compounds that increase CYP@A@ activity may alter the efficacy and safety of erlotinib therapy .


Two phase I studies were conducted in healthy male subjects to evaluate the effect of pre - or co-administered rifampicin , a CYP@A@ inducer , on the pharmacokinetics of erlotinib .


Study @ included Groups A ( erlotinib @ mg days @ and @ , rifampicin @ mg days @-@ ) and B ( erlotinib @ mg days @ and @ ) in a parallel group study design .


Study @ subjects received erlotinib @ mg day @ , erlotinib @ mg day @ , and rifampicin @ mg days @-@ .


The primary endpoint in each study was the ratio of exposure ( AUC@ - and C max ) between days @ and @ .


Urinary cortisol metabolic induction ratios were determined in Study @ for Group A subjects only .


In Study @ , the geometric mean ratios of AUC@ - and C max were @ and @ % , respectively , and the mean cortisol metabolic index increased from @ to @ , suggesting cytochrome P@ ( CYP ) enzyme induction .


In Study @ , the geometric mean ratios for AUC@ - and C max were @ and @ % ( when dose adjusted from @ to @ mg erlotinib ) , respectively , a greater relative decrease than observed in Study @ .


Erlotinib exposure ( AUC@ - and C max ) was reduced after pre - or concomitant dosing with rifampicin .


Doses of @ mg erlotinib may be necessary to compensate for concomitant medications with strong CYP@A@ enzyme induction effect .


Radiostereometric analysis provides highly precise measurements of component micromotion relative to the bone that is otherwise undetectable by routine radiographs .


This study compared , at a minimum of five years following surgery , the micromotion of tantalum and titanium acetabular cups and femoral head penetration in highly cross-linked polyethylene liners and conventional ( ultra-high molecular weight polyethylene ) liners in active patients who had undergone total hip replacement .


This institutional review board-approved prospective , randomized , blinded study involved forty-six patients .


Patients were randomized into one of four cohorts according to both acetabular cup and polyethylene liner .


Patients received either a cementless cup with a titanium mesh surface or a tantalum trabecular surface and either a highly cross-linked polyethylene liner or an ultra-high molecular weight polyethylene liner .


Radiostereometric analysis examinations and Short Form-@ Physical Component Summary , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , University of California Los Angeles ( UCLA ) activity , and Harris hip scores were obtained preoperatively , postoperatively , at six months , and annually thereafter .


All patients had significant improvement ( p < @ ) in Short Form-@ Physical Component Summary , WOMAC , UCLA activity , and Harris hip scores postoperatively .


On radiostereometric analysis examination , highly cross-linked polyethylene liners showed significantly less median femoral head penetration at five years ( p < @ ) .


Steady-state wear rates from one year to five years were @ mm per year for ultra-high molecular weight polyethylene liners and @ mm per year for highly cross-linked polyethylene liners .


At the five-year follow-up , the median migration ( and standard error ) was @ @ mm proximally for titanium cups and @ @ mm for tantalum cups .


In this young population who had undergone total hip replacement , radiostereometric analysis showed significantly less femoral head penetration in the highly cross-linked polyethylene liners compared with that in the conventional ultra-high molecular weight polyethylene liners .


Penetration rates were one order of magnitude less in highly cross-linked polyethylene liners compared with ultra-high molecular weight polyethylene liners .


There was no significant difference in proximal migration between the tantalum and titanium acetabular cups through the five-year follow-up ( p > @ ) .


Inactivity and sedentary behavior are related to poorer health outcomes in breast cancer survivors .


However , few studies examining these behaviors in survivors have used objective measures , considered activities other than moderate-to-vigorous intensity activity ( MVPA ) and/or sedentary behavior ( i.e. low intensity activities ) or compared survivors to healthy controls .


The purpose of the present study is to compare accelerometer-measured activity of various intensities ( total , light , lifestyle , MVPA ) and sedentary behavior between breast cancer survivors and non-cancer controls .


An imputation-based approach of independent sample t-tests adjusting for multiple comparisons was used to compare estimates of participation in each activity and sedentary behavior between survivors -LSB- n = @ ; M ( SD ) age = @ ( @ ) -RSB- and block-matched non-cancer controls -LSB- n = @ ; M ( SD ) age = @ ( @ ) -RSB- .


Potential moderating effects of body mass index ( BMI ) , age , and education were also examined .


Breast cancer survivors registered less daily total ( @ v. @ ) light ( @ v. @ ) and lifestyle ( @ v. @ ) activity minutes and more MVPA ( @ v. @ ) and sedentary behavior ( @ v. @ ) minutes than controls ( p < @ for all ) .


These relationships were largely consistent across BMI , age and education .


On average , survivors spent an estimated @ % of their waking time sedentary and @ % in light/lifestyle activity and @ % in MVPA .


Breast cancer survivors are more sedentary and participate in less low intensity activity than controls .


Although survivors registered more MVPA , these levels were insufficient .


Future research should explore these differences and potential benefits of targeting low intensity activities and reducing sedentary time in this population .


Scarring represents a significant biomedical burden in clinical medicine .


Mechanomodulation has been linked to scarring through inflammation , but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible .


The authors conducted a @-month , prospective , open-label , randomized , multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions .


Incisions from @ healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment ( surgeon 's optimal care methods ) on the other half .


The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score .


Final @-month study photographs were obtained from @ subjects who completed at least @ weeks of dressing application .


The mean visual analogue scale score for embrace-treated scars ( @ ) was significantly improved compared with control-treated scars ( @ ) at @ months ( difference , @ ; @ percent confidence interval , @ to @ ; p = @ ) .


Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at @ months using the Patient and Observer Scar Assessment Scale evaluation ( p = @ and p < @ , respectively ) .


No serious adverse events were reported .


These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery .


To the authors ' knowledge , this represents the first level I evidence for postoperative scar reduction .


Therapeutic , II .


Peritoneal dialysis ( PD ) requires patients to take an active role in their adherence to fluid restrictions .


Although fluid non-adherence had been identified among this patient group , no specific interventions have been researched or published with in the PD population .


The current study sought to investigate whether an applied cognitive behavioural therapy ( CBT-based intervention ) used among haemodialysis patients would improve fluid adherence among PD patients ; utilizing clinical indicators used in practice .


Fifteen PD patients identified as fluid non-adherent were randomly assigned to an intervention group ( IG ) or a deferred-entry control group ( CG ) .


The study ran for a total of @ weeks , with five data collection points ; at baseline , post-intervention and at three follow-up points ; providing a RCT phase and a combined longitudinal analysis phase .


The content of the group intervention encompassed educational , cognitive and behavioural components , aimed to assist patients ' self-management of fluid .


No significant differences in weight ( kg ) reduction were found in either phase and undesirable changes in blood pressure ( BP ) were observed .


However , in the longitudinal phase , a statistically significant difference in oedematous status was observed at @-week follow-up ; which may be indicative of fluid adherence .


Positive and significant differences were observed in the desired direction for measures of psychological well-being , quality of life and health beliefs ; areas correlated with enhanced fluid adherence in other research .


This study reveals encouraging and significant changes in predictors of fluid adherence .


Although there were no significant changes in weight as a crude clinical measure of fluid intake , significant reductions in oedematous status were observed as a consequence of this CBT-based group intervention .


This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting ( PONV ) in patients who received prophylactic ondansetron .


Although guidelines recommend use of an agent from a different class when prophylaxis has failed , palonosetron has unique properties relative to other serotonin @-HT@ receptor antagonists .


Prior trials assessing its use for rescue have had conflicting results .


Although palonosetron has compared favorably with ondansetron for PONV prevention , the drugs have not been compared in the rescue setting of failure of @-HT@ receptor antagonist prophylaxis .


This was a randomized , open-label , multicenter trial comparing the efficacy and safety of intravenous palonosetron @ mg and intravenous ondansetron @mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron .


Of @ patients screened , @ were enrolled and @ were treated for PONV : @ and @ in the palonosetron and ondansetron arms , respectively .


Complete control during @hours after study drug administration was achieved in @ % of palonosetron recipients and @ % of ondansetron recipients ( @ % confidence interval -LSB- CI -RSB- , -@ , @ ; p = @ ) .


Corresponding incidences of vomiting were @ % for palonosetron and @ % for ondansetron ( @ % CI , -@ , @ ; p = @ ) , and @ % and @ % required additional rescue treatment , respectively ( @ % CI , -@ , @ ; p = @ ) .


Other than a similar incidence of procedural pain in the @ groups , the most common treatment-emergent adverse events , which were generally mild , were headache ( @ % vs @ % ) , constipation ( @ % vs @ % ) , and dizziness ( @ % vs @ % ) , for the palonosetron and ondansetron groups , respectively .


Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the @hours after study drug administration .


There was a trend toward less emesis in the @-@h time period favoring palonosetron .


While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV , the benefit , if any , would be limited based on this study .


Current methods of the transtibial pull-out meniscal root repair significantly displace under cyclic loading in porcine models but have not been evaluated in human models .


One potential explanation for the displacement is that a single transtibial tunnel may not fully restore the attachment of the entire posterior medial meniscal root .


The purpose of this study was to biomechanically evaluate the transtibial pull-out technique in a human cadaveric model using either @ or @ transtibial bone tunnels .


The hypothesis was that a transtibial pull-out technique using @ transtibial bone tunnels would confer superior biomechanical properties in comparison to an iteration using @ transtibial bone tunnel .


Controlled laboratory study .


Ten matched pairs of male human cadaveric knees ( average age , @ years ) were randomly assigned ( @ each of the pair ) to @ groups consisting of a transtibial pull-out technique using either @ or @ transtibial bone tunnels .


The knees were cyclically loaded for @ cycles from @ to @ N at @ Hz , representing the loads experienced during a typical meniscal root repair postoperative rehabilitation program , and then pulled to failure at a rate of @ mm/s .


Differences between @ - and @-tunnel repair groups were neither statistically nor clinically significant with respect to displacement or ultimate failure load .


On average , the @ - and @-tunnel repair groups resulted in @ mm and @ mm of displacement , respectively , after @ testing cycles .


At @ , @ , @ , and @ testing cycles , displacement was not significantly different between groups ( P > @ ) .


The @-tunnel repair technique resulted in a @ % higher ultimate failure load ( @ N vs. @ N ) ; however , this was not significant ( P = @ ) .


Similar biomechanical properties were seen between transtibial pull-out repairs using either @ or @ transtibial bone tunnels in a human cadaveric model .


Both repair groups exceeded the @-mm threshold for nonanatomic displacement .


This study indicates that a newly proposed iteration of the transtibial pull-out repair technique using a second transtibial tunnel , which theoretically restores more of the posterior medial meniscal root , was almost identical to the current clinical standard involving a single transtibial tunnel .


As the importance of repairing meniscal root tears is increasingly recognized , further studies on new iterations of both techniques are warranted to minimize the risk of displacement caused by early motion in the initial postoperative rehabilitation period .


Several evidence-based treatments are available to veterans diagnosed with posttraumatic stress disorder ( PTSD ) .


However , not all veterans benefit from these treatments or prefer to engage in them .


The current study explored whether ( @ ) a mantram repetition program ( MRP ) increased mindful attention among veterans with PTSD , ( @ ) mindful attention mediated reduced PTSD symptom severity and enhanced psychological well-being , and ( @ ) improvement in mindful attention was due to the frequency of mantram repetition practice .


Data from a randomized controlled trial comparing MRP plus treatment as usual ( MRP+TAU ) or TAU were analyzed using hierarchical linear models .


A total of @ veterans with PTSD from military-related trauma were recruited from a Veterans Affairs outpatient PTSD clinic ( @ MRP+TAU ; @ TAU ) .


The Clinician Administered PTSD Scale ( CAPS ) , PTSD Checklist ( PCL ) , the Brief Symptom Inventory-@ depression subscale , Health Survey SF-@v@ , and Mindfulness Attention Awareness Scale ( MAAS ) were used .


Frequency of mantram repetition practice was measured using wrist-worn counters and daily logs .


Intent-to-treat analyses indicated greater increases in mindful attention , as measured by the MAAS , for MRP+TAU as compared with TAU participants ( P < @ ) .


Mindful attention gains mediated previously reported treatment effects on reduced PTSD symptoms ( using both CAPS and PCL ) , reduced depression , and improved psychological well-being .


Frequency of mantram repetition practice in turn mediated increased mindful attention .


The MRP intervention and specifically , mantram practice , improved mindful attention in veterans with PTSD , yielding improved overall psychological well-being .


MRP may be a beneficial adjunct to usual care in veterans with PTSD .


ODM-@ is a novel androgen receptor ( AR ) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation .


This trial assessed ODM-@ 's safety , pharmacokinetics , and activity in men with metastatic castration-resistant prostate cancer .


The ARADES trial is an open-label phase @-@ trial undertaken in @ hospitals across Europe and USA with ongoing long-term follow-up .


Men with progressive metastatic castration-resistant prostate cancer , who had castrate concentrations of testosterone and an Eastern Cooperative Oncology Group score of @-@ were enrolled .


In the phase @ part of the trial , patients were given oral ODM-@ at a starting daily dose of @ mg , which was increased to @ mg , @ mg , @ mg , @ mg , and @ mg .


In phase @ , patients were randomly assigned centrally and stratified by previous chemotherapy and treatment with CPY@ inhibitors , to receive one of three daily doses of ODM-@ ( @ mg , @ mg , and @ mg ) .


The primary endpoint in phase @ was safety and tolerability , whereas in phase @ it was the proportion of patients with a PSA response ( @ % or greater decrease in serum PSA ) at week @ .


All analyses included patients who had received at least one dose of ODM-@ .


This trial is registered with ClinicalTrials.gov , number NCT@ , and NCT@ for the follow-up after @ weeks .


We enrolled patients between April @ , @ , and March @ , @ .


In phase @ , @ patients were enrolled to six sequential cohorts of three to six patients and received a daily dose of ODM-@ , @-@ mg .


No dose-limiting toxic effects were reported and the maximum tolerated dose was not reached .


In phase @ , three patients reported eight adverse events of grade @ ( fracture , muscle injury , laceration , paralytic ileus , pain , presyncope , urinary retention , and vomiting ) and one patient had a grade @ adverse event ( lymphoedema ) .


None of the grade @-@ adverse events were deemed to be related to ODM-@ .


Of the phase @ patients , the four who received @ mg , seven who received @ mg , and three who received @ mg entered the phase @ part of the trial .


In addition to these patients , @ were randomly assigned to three groups : @ mg ( n = @ ) , @ mg ( n = @ ) , and @ mg ( n = @ ) .


For these patients , the most common treatment-emergent adverse events were fatigue or asthenia ( @ -LSB- @ % -RSB- of @ patients ) , hot flush ( six -LSB- @ % -RSB- ) , and decreased appetite ( five -LSB- @ % -RSB- ) .


One patient ( < @ % ) had a grade @ treatment-emergent adverse event ( fatigue ) ; no patients had a treatment-emergent grade @ adverse event .


@ patients who received @ mg , @ who received @ mg , and @ who received @ mg were assessable for PSA response at @ weeks .


@ ( @ % ) patients in the @ mg group , @ ( @ % ) in the @ mg group , and @ ( @ % ) in the @ mg group had a PSA response at @ weeks .


Our results suggest that ODM-@ monotherapy in men with progressive metastatic castration-resistant prostate cancer provides disease suppression and that ODM-@ has a favourable safety profile .


These findings support further investigation of clinical responses with ODM-@ in men with castration-resistant prostate cancer .


The United Kingdom Employment Retention and Advancement ( U.K. ERA ) demonstration was the largest and most comprehensive social experiment ever conducted in the United Kingdom .


It examined the extent to which a combination of postemployment advisory support and financial incentives could help lone parents on welfare to find sustained employment with prospects for advancement .


ERA was experimentally tested across more than @ public employment service offices and , within each office , individuals were randomly assigned to either a program ( or treatment ) group ( eligible for ERA ) or a control group ( not eligible ) .


This article presents the results of a multilevel nonexperimental analysis that examines the variation in office-level impacts and attempts to understand what services provided in the offices tend to be associated with impacts .


The analysis suggests that impacts were greater in offices that emphasized in-work advancement , support while working and financial bonuses for sustained employment , and also in those offices that assigned more caseworkers to ERA participants .


Offices that encouraged further education had smaller employment impacts .


Plausible results are obtained identifying those particular implementation features that tended to be linked to stronger impacts of ERA .


The methodology employed also allows the identification of which services are associated with employment and welfare receipt of control families receiving benefits under the traditional New Deal for Lone Parent program .


Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring .


To date , there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring .


To compare the efficacy of palatal implant and radiofrequency surgery , in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis .


Thirty patients with habitual snoring due to palatal obstruction ( apnea-hypopnea index @ , body max index @ ) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia .


Snoring was primarily evaluated by the patient with a @ cm visual analogue scale ( VAS ) at baseline and at a @-month follow-up visit and the change in VAS was the primary outcome .


Moreover , life qualities , measured by snore outcomes survey , and full-night snoring sounds , analyzed by a sound analytic program ( Snore Map ) , were also investigated at the same time .


Twenty-eight patients completed the study ; @ received palatal implant surgery and @ underwent radiofrequency surgery .


The VAS and snore outcomes survey scores were significantly improved in both groups .


However , the good response ( postoperative VAS @ or postoperative VAS @ plus snore outcomes survey score @ ) rate of the palatal implant group was significantly higher than that of the radiofrequency group ( @ % vs. @ % , P = @ ) .


The maximal loudness of low-frequency ( @-@ Hz ) snores was reduced significantly in the palatal implant group .


In addition , the snoring index was significantly reduced in the radiofrequency group .


Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes , but palatal implants have a greater effect on most measures of subjective and objective snoring .


Multi-stage radiofrequency surgery was not tested .


To investigate whether a maneuver for repeated cycles of collapse and reexpansion of the operative lung , termed `` intermittent reinflation '' ( IR ) , to counter hypoxemia during one-lung ventilation ( OLV ) , results in a time-dependent alteration of extravascular lung water .


Prospective , randomized clinical study .


Operating room and postsurgical intensive care unit of a university hospital .


@ ASA physical status @ and @ patients undergoing elective , video-assisted thoracic surgery for lung tumors .


Patients were randomly assigned to two groups .


Group C consisted of @ patients whose nondependent lung was kept collapsed during OLV , while Group IR included @ patients with IR that consisted of @ separate , @-second manual inflations and @-second openings within one minute at intervals of @ minutes during OLV .


Perioperative parameters included transcutaneous oxygen saturation ( SpO@ ) , hemodynamic data , extravascular lung water index ( EVLWI ) , pulmonary vascular permeability index ( PVPI ) as determined by the single-indicator transpulmonary thermodilution technique , and partial pressure of arterial oxygen/inspired oxygen fraction ( PaO@/FIO@ ) ratio .


Group IR had significantly higher SpO@ at @ minutes after commencement of OLV ( @ % vs @ % , P = @ ) and average SpO@ throughout OLV ( @ % vs @ % , P = @ ) .


Hemodynamic data , EVLWI , PVPI , and PaO@/FIO@ ratio did not differ between the groups , and there were no differences between groups in postoperative morbidity or hospital stay .


Intermittent reinflation had a beneficial effect on oxygenation during OLV , without any significant effects on EVLW or postoperative outcomes .


To report and discuss the multi-domain impact of elosulfase alfa , with focus on tertiary and composite endpoints , in the @-week , randomized , double-blind , placebo-controlled phase @ trial in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .


Patients with Morquio A syndrome aged @ years were randomized @:@:@ to elosulfase alfa @ mg/kg/week ( qw ; N = @ ) , elosulfase alfa @ mg/kg/every other week ( qow ; N = @ ) , or placebo ( N = @ ) for @ weeks .


Primary and secondary efficacy measures were @-minute walk test ( @MWT ; primary ) , @-minute stair climb test ( @-MSCT ) and urinary keratan sulfate ( KS ) .


Safety was also evaluated .


Tertiary efficacy measures included respiratory function measures , activities of daily living ( MPS Health Assessment Questionnaire -LSB- MPS-HAQ -RSB- ) , anthropometric , echocardiographic and radiographic measures , hearing and corneal clouding assessment .


In order to fully characterize treatment impact in this heterogeneous disorder , the effect of elosulfase alfa on composite efficacy measures was evaluated as well .


The study was not designed to have sufficient power for any of the tertiary outcomes .


For most tertiary endpoints , subjects treated with the weekly dose of elosulfase alfa improved more than those receiving placebo .


The largest treatment effects were seen in maximal voluntary ventilation ( MVV ) , MPS-HAQ , height , and growth rate .


The qow group appeared similar to placebo .


The analysis of a pre-specified composite endpoint ( combining changes from baseline in @MWT , @MSCT and MVV z-scores equally weighted ) showed a modest positive impact of elosulfase alfa qw versus placebo group ( P = @ ) .


As a pre-specified supportive analysis , the O'Brien Rank Sum composite endpoint ( changes from baseline in @MWT , @MSC , and MVV ) , analysis also showed that the qw group performed better than the placebo group ( P = @ ) .


In post-hoc analyses , combinations of other endpoints were also explored using the O'Brien Rank Sum test and showed statistically significant differences between elosulfase alfa qw and placebo favoring elosulfase alfa qw .


Differences between elosulfase alfa qow and placebo were not statistically significant .


Positive changes were observed in most tertiary variables , demonstrating the efficacy of weekly treatment with elosulfase alfa .


Treatment with weekly elosulfase alfa led to improvements across most efficacy measures , resulting in clinically meaningful benefits in a heterogeneous study population .


Acute myocardial infarction ( AMI ) is the leading cause of mortality worldwide .


Oxidative stress has been involved in the ischemia-reperfusion injury in AMI .


It has been suggested that reperfusion accounts for up to @ % of the final size of a myocardial infarct , a part of the damage likely to be prevented.Therefore , we propose that antioxidant reinforcement through vitamins C and E supplementation should protect against the ischemia-reperfusion damage , thus decreasing infarct size.The PREVEC Trial ( Prevention of reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction ) seeks to evaluate whether antioxidant vitamins C and E reduce infarct size in patients subjected to percutaneous coronary angioplasty after AMI .


This is a randomized , @:@ , double-blind , placebo-controlled clinical trial.The study takes place at two centers in Chile : University of Chile Clinical Hospital and San Borja Arriarn Clinical Hospital.The subjects will be @ adults with acute myocardial infarction with indication for percutaneous coronary angioplasty.This intervention is being performed as a pilot study , involving high-dose vitamin C infusion plus oral administration of vitamin E ( Vitamin-treatment group ) or placebo ( Control group ) during the angioplasty procedure .


Afterward , the Vitamin-treatment group receives oral doses of vitamins C and E , and the Control group receives placebo for @ days after coronary angioplasty.Primary outcome is infarct size , assessed by cardiac magnetic resonance ( CMR ) , measured @ and @ days after coronary angioplasty.Secondary outcomes are ejection fraction , measured @ and @ days after coronary angioplasty with CMR , and biomarkers for oxidative stress , antioxidant status , heart damage , and inflammation , which will be measured at baseline , at the onset of reperfusion , @ to @ hours after revascularization , and at hospital discharge .


The ischemia-reperfusion event occurring during angioplasty is known to increase myocardial infarct size .


The cardioprotective benefits of high doses of vitamin C combined with vitamin E have not been fully explored .


The PREVEC Trial seeks to determine the suitability of the therapeutic use of vitamins C and E against the reperfusion damage produced during angioplasty.Patient recruitment opened in February @ .


The trial is scheduled to end in March @ .


To evaluate the safety and efficacy of dexamethasone intravitreal implant ( Ozurdex , DEX implant ) @ and @ mg in the treatment of patients with diabetic macular edema ( DME ) .


Two randomized , multicenter , masked , sham-controlled , phase III clinical trials with identical protocols were conducted .


Data were pooled for analysis .


Patients ( n = @ ) with DME , best-corrected visual acuity ( BCVA ) of @/@ to @/@ Snellen equivalent , and central retinal thickness ( CRT ) of @ m by optical coherence tomography .


Patients were randomized in a @:@:@ ratio to study treatment with DEX implant @ mg , DEX implant @ mg , or sham procedure and followed for @ years ( or @ months for patients treated at month @ ) at @ scheduled visits .


Patients who met retreatment eligibility criteria could be retreated no more often than every @ months .


The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of @-letter improvement in BCVA from baseline at study end .


Safety measures included adverse events and intraocular pressure ( IOP ) .


Mean number of treatments received over @ years was @ , @ , and @ with DEX implant @ mg , DEX implant @ mg , and sham , respectively .


The percentage of patients with @-letter improvement in BCVA from baseline at study end was greater with DEX implant @ mg ( @ % ) and DEX implant @ mg ( @ % ) than sham ( @ % ; P @ ) .


Mean average reduction in CRT from baseline was greater with DEX implant @ mg ( -@ m ) and DEX implant @ mg ( -@ m ) than sham ( -@ m ; P < @ ) .


Rates of cataract-related adverse events in phakic eyes were @ % , @ % , and @ % in the DEX implant @ mg , DEX implant @ mg , and sham groups , respectively .


Increases in IOP were usually controlled with medication or no therapy ; only @ patients ( @ % ) in the DEX implant @ mg group and @ ( @ % ) in the DEX implant @ mg group required trabeculectomy .


The DEX implant @ mg and @ mg met the primary efficacy endpoint for improvement in BCVA .


The safety profile was acceptable and consistent with previous reports .


To explore the effects of early intervention of acupuncture on urinary function reconstruction of neurogenic bladder after spinal cord injury , so as to find the optimal treatment timing of acupuncture .


Fifty-three patients of neurogenic bladder after spinal cord injury were randomly divided into a prior-to-catheter group ( @ cases ) and a posterior-to-catheter group ( @ cases ) .


For the prior-to-catheter group , one week before the removal of catheter , acupoints on the abdomen and back such as Guanyuan ( CV @ ) , Zhongji ( CV @ ) , Baliao ( Shangliao ( BL @ ) , Ciliao ( BL @ ) , Zhongliao ( BL @ ) , Xialiao ( BL @ ) , Jiaji ( EX-B @ ) and acupoints at distal end such as Zusanli ( ST @ ) and Sanyinjiao ( SP @ ) were selected ; after the catheter removal , simple method .


of water column was used to measure bladder capacity pressure to classify the type of bladder , and then different acupuncture manipulations were given ; intermittent catheterization was performed if condition was allowed .


The posterior-to-catheter group applied identical treatment after removal of catheter as the prior-to-catheter group .


The treatment was given @ times per week ; after one-month treatment , five aspects including the time of first effective urination , time of establishing reflex urination , average residual volume of urine , time of residual urine less than @ mL and quality of life ( QOL ) were evaluated .


After treatment , the time of first effective urination , time of establishing reflex urination , average residual volume of urine and time of residual urineless than @ mL in the prior-to-catheter group were all superior to those in the posterior-to-catheter group ( all P < @ ) ; the score of QOL was improved in two groups after treatment ( both P < @ ) , but the difference between two groups was not statistically significant ( P > @ ) ; each index of urination function was not significant among patients with different injured segments of spinal cord ( all P > @ ) .


The early intervention of acupuncture ( prior to catheter ) has obvious improving function on establishing balanced bladder in patients with neurogenic bladder after spinal cord injury , which is superior to acupuncture intervention after removal of catheter , however , the effects of different injured segments on establishing balanced bladder are not different .


To identify a group of deliveries to mothers with indicators of subfertility ( SUBFERTILITY ) .


Longitudinal cohort study .


Hospital .


A total of @,@ deliveries to Massachusetts mothers in a Massachusetts hospital between July @ , @ , and December @ , @ .


None .


Subfertility was defined by an indication on a current or past birth certificate or hospital utilization data of infertility or assisted reproductive technology ( ART ) cycle before index delivery and no indication of ART use with index delivery .


Initially , @,@ deliveries met the inclusion criteria for SUBFERTILITY ( @,@ from birth certificates , @,@ from hospital data , @,@ from prior ART treatment ) .


Removing deliveries from more than one data source resulted in @,@ unique deliveries .


Removing deliveries resulting from ART treatments left @,@ deliveries in the SUBFERTILITY category .


Demographic analysis indicated that deliveries in SUBFERTILITY were more similar to those in the ART population than to those in the fertile population .


We have demonstrated the feasibility of using existing population-based linked public health data sets to identify SUBFERTILITY deliveries , and we have used ART data to distinguish ART and SUBFERTILITY births .


The SUBFERTILITY category can serve as a comparison group of subfertile patients for studies of ART delivery and longitudinal health outcomes .


Idrabiotaparinux , a long-acting inhibitor of factor Xa , was shown to be effective in the treatment of patients with venous thromboembolism .


To assess non-inferiority for the efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation ( AF ) at risk of stroke and systemic embolism .


Bleeding was also assessed .


This randomized , double-blind trial enrolled patients with electrocardiogram-documented AF .


Idrabiotaparinux was administered weekly via subcutaneous injection , and warfarin was administered daily with dose adjustment to maintain the international normalized ratio between @ and @ .


Each idrabiotaparinux injection was @ mg for the first @ weeks , followed by @ mg thereafter , except in patients with a creatinine clearance of @-@ mL min ( -@ ) or aged @ years .


The patients received @ mg after the first @ weeks .


The efficacy outcome was the composite of all fatal or non-fatal strokes and systemic embolism .


The safety outcome was clinically relevant bleeding ( major and clinically relevant non-major bleeding ) .


The study was terminated prematurely by the sponsor for strategic/commercial , not scientific , reasons , with @ % of the planned number of patients included and an average duration of treatment of @ days .


Of the @ idrabiotaparinux recipients , @ developed stroke or systemic embolism ( @ % per year ) , whereas this occurred in @ of the @ warfarin patients ( @ % per year , hazard ratio @ , @ % confidence interval @-@ @ ) .


The annual incidence of bleeding was @ % in the idrabiotaparinux and @ % in the warfarin group ( hazard ratio @ , @ % confidence interval @-@ @ ) .


If anything , despite its early termination , the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin , with a lower bleeding risk .


Low rates of adherence to artemisinin-based combination therapy ( ACT ) regimens increase the risk of treatment failure and may lead to drug resistance , threatening the sustainability of current anti-malarial efforts .


We assessed the impact of text message reminders on adherence to ACT regimens .


Health workers at hospitals , clinics , pharmacies , and other stationary ACT distributors in Tamale , Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment .


The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability ; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in @-hour intervals .


The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation .


We estimated the impact of the messages on treatment completion using logistic regression .


@ individuals enrolled in both the study and the text reminder system .


Among individuals in the control group , @ % took the full course of treatment .


The simple text message reminders increased the odds of adherence ( adjusted OR @ , @ % CI -LSB- @ to @ -RSB- , p-value @ ) .


Receiving an additional message did not result in a significant change in adherence ( adjusted OR @ , @ % CI -LSB- @ to @ -RSB- , p-value @ ) .


The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment .


Further research is needed to develop the most effective text message content and frequency .


We sought to define normative visual field ( VF ) values for children using common clinical test protocols for kinetic and static perimetry .


Prospective , observational study .


We recruited @ children aged @ to @ years without any ophthalmic condition that would affect the VF ( controls ) from pediatric clinics at Moorfields Eye Hospital .


Children performed perimetric assessments in a randomized order using Goldmann and Octopus kinetic perimetry , and Humphrey static perimetry ( Swedish Interactive Thresholding Algorithm -LSB- SITA -RSB- @-@ FAST ) , in a single sitting , using standardized clinical protocols , with assessment by a single examiner .


Unreliable results ( assessed qualitatively ) were excluded from the normative data analysis .


Linear , piecewise , and quantile mixed-effects regression models were used .


We developed a method to display age-specific normative isopters graphically on a VF plot to aid interpretation .


Summary measures and graphical plots describing normative VF data for @ common perimetric tests .


Visual field area increased with age on testing with Goldmann isopters III@e , I@e , and I@e ( linear regression ; P < @ ) and for Octopus isopters III@e and I@e ( linear regression ; P < @ ) .


Visual field development occurs predominately in the inferotemporal field .


Humphrey mean deviation ( MD ) showed an increase of @ decibels ( dB ; @ % CI , @-@ @ ) MD per year up to @ years of age , when adult MD values were reached and thereafter maintained .


Visual field size and sensitivity increase with age in patterns that are specific to the perimetric approach used .


These developmental changes should be accounted for when interpreting perimetric test results in children , particularly when monitoring change over time .


Guidelines for SPECT myocardial perfusion imaging ( MPI ) traditionally recommend a fixed tracer dose .


Yet , clinical practice shows degraded image quality in heavier patients .


The aim was to optimize and validate the tracer dose and scan time to obtain a constant image quality less dependent on patients ' physical characteristics .


@ patients underwent Cadmium Zinc Telluride ( CZT ) - SPECT stress MPI using a fixed Tc-@m-tetrofosmin tracer dose .


Image quality was scored by three physicians on a @-point grading scale and related to the number of photon counts normalized to tracer dose and scan time .


Counts were correlated with various patient-specific parameters dealing with patient size and weight to find the best predicting parameter .


From these data , a formula to provide constant image quality was derived , and subsequently tested in @ new patients .


Degradation in image quality and photon counts was observed for heavier patients for all patients ' specific parameters ( P < @ ) .


We found body weight to be the best-predicting parameter for image quality and derived a new dose formula .


After applying this new body weight-depended tracer dose and scan time in a new group , image quality was found to be constant ( P > @ ) in all patients .


Also in CZT SPECT image quality decreases with weight .


The use of a tracer dose and scan time that depends linearly on patient 's body weight corrected for the varying image quality in CZT-SPECT MPI .


This leads to better radiation exposure justification .


No randomised study has shown whether stratification of treatment by minimal residual disease ( MRD ) response improves outcome in children and young people with acute lymphoblastic leukaemia ( ALL ) .


We assessed whether children and young people with clinical standard and intermediate-risk ALL who have persistent MRD at the end of induction therapy benefit from augmented post-remission therapy .


Between Oct @ , @ , and June @ , @ , we enrolled eligible patients aged @-@ years and initially categorised them into clinical standard-risk , intermediate-risk , and high-risk groups on the basis of a combination of National Cancer Institute criteria , cytogenetics , and early morphological response to induction therapy .


Clinical standard-risk and intermediate-risk patients with MRD of @ % or higher at day @ of induction ( MRD high risk ) were randomly assigned ( @:@ ) to standard therapy ( treatment regimens A and B ) or augmented post-remission therapy ( regimen C ) .


Compared with standard therapy , the augmented treatment regimen ( regimen C ) included an additional eight doses of pegylated asparaginase , @ doses of vincristine , and escalated-dose intravenous methotrexate without folinic acid rescue during interim maintenance courses .


Computer randomisation was used for treatment allocation and was balanced for sex , age ( < @ years vs @ years ) , and white blood cell count at diagnosis ( < @ ( @ ) / L vs @ ( @ ) / L ) by minimisation .


Patients , clinicians , and data analysts were not masked to treatment allocation .


The primary outcomes were event-free survival and overall survival .


Analyses were by intention to treat .


This trial is registered with Current Controlled Trials , number ISRCTN@ .


@ MRD high-risk patients were randomly assigned to receive standard ( n = @ ) or augmented ( n = @ ) post-remission therapy .


After a median follow-up of @ months ( IQR @-@ ) , @-year event-free survival was better in the augmented treatment group ( @ % -LSB- @ % CI @-@ -RSB- ) than in the standard group ( @ % -LSB- @-@ -RSB- ; odds ratio -LSB- OR -RSB- @ -LSB- @ % CI @-@ -RSB- , p = @ ) .


Overall survival at @ years was numerically , but not significantly , higher in the augmented treatment group ( @ % -LSB- @ % CI @-@ -RSB- ) than in the standard therapy group ( @ % -LSB- @-@ -RSB- ; OR @ -LSB- @ % CI @-@ -RSB- , p = @ ) .


More adverse events occurred in the augmented treatment group than in the standard group ( asparaginase-related hypersensitivity in @ -LSB- @ % -RSB- in the augmented group vs two -LSB- @ % -RSB- in the standard group and asparaginase-related pancreatitis in eight -LSB- @ % -RSB- vs one -LSB- @ % -RSB- ; intravenous methotrexate-related mucositis in @ -LSB- @ % -RSB- vs three -LSB- @ % -RSB- and methotrexate-related stomatitis in @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Our findings suggest that children and young people with acute lymphoblastic leukaemia and @ % or more MRD at the end of remission induction therapy could benefit from augmented post-remission therapy .


However , the asparaginase and intravenous methotrexate used in the augmented treatment regimen is associated with more adverse events than is the standard post-remission treatment regimen .


Quantification of molecular cell processes is important for prognostication and treatment individualization of head and neck cancer ( HNC ) .


However , individual tumor comparison can show discord in upregulation similarities when analyzing multiple biological mechanisms .


Elaborate tumor characterization , integrating multiple pathways reflecting intrinsic and microenvironmental properties , may be beneficial to group most uniform tumors for treatment modification schemes .


The goal of this study was to systematically analyze if immunohistochemical ( IHC ) assessment of molecular markers , involved in treatment resistance , and @F-FDG PET parameters could accurately distinguish separate HNC tumors .


Several imaging parameters and texture features for @F-FDG small-animal PET and immunohistochemical markers related to metabolism , hypoxia , proliferation and tumor blood perfusion were assessed within groups of BALB/c nu/nu mice xenografted with @ human HNC models .


Classification methods were used to predict tumor line based on sets of parameters .


We found that @F-FDG PET could not differentiate between the tumor lines .


On the contrary , combined IHC parameters could accurately allocate individual tumors to the correct model .


From @ analyzed IHC parameters , a cluster of @ random parameters already classified @ % correctly .


Combining all PET/IHC characteristics resulted in the highest tumor line classification accuracy ( @ % ; cross validation @ % ) , which was just @ % higher ( p = @-@ ) than the performance of the IHC parameter/feature based model .


With a select set of IHC markers representing cellular processes of metabolism , proliferation , hypoxia and perfusion , one can reliably distinguish between HNC tumor lines .