We included follow-up measures with the AHRS and PANAS at four weeks and three months .


The interaction between time and treatment for Hallucination item P3 of the PANSS showed a trend for significance , caused by a small reduction of scores in the left group .


Although self-reported hallucination scores , as measured with the AHRS and PANAS , decreased significantly during the trial period , there were no differences between the three treatment groups .


We did not find convincing evidence for the efficacy of left-sided rTMS , compared to sham rTMS .


Moreover , bilateral rTMS was not superior over left rTMS or sham in improving AVH .


Optimizing treatment parameters may result in stronger evidence for the efficacy of rTMS treatment of AVH .


Moreover , future research should consider investigating factors predicting individual response .


Dutch Trial Register NTR1813 .


The period from the mid-1990s to the mid-2000s saw a rapid increase in long-term sick leave in Sweden , primarily due to mental illness and often related to job burnout .


This led to an urge for effective treatment programs that could prevent the often long sick leaves .


In 2010 we presented a newly developed work-place intervention method , showing that 89 % of the intervention group had returned to work at a 1.5 year follow-up , compared to 73 % of the control group .


The main aim of this study was to assess the long-term stability of these promising results .


Sick leave registry data from the Regional Social Insurance Office were analyzed for an additional year ( 50weeks ) beyond the original 1.5 year period ( 80weeks ) .


Data from 68 matched pairs of intervention participants ( IP ) and controls were available .


The proportions of participants being on full-time sick leave versus having returned to work to any extent were computed for every 10th week .


Generalized estimating equations were used with GROUP ( IP versus controls ) as between-subjects factor , WEEKS and AGE as covariates , and return-to-work ( RTW ) as dependent variable .


Significant differences ( Wald 2 with .05 ) was followed up with polynomial contrasts .


Individual relapses to higher degrees of sick leave ( e.g. from 50 % to 100 % ) and whether partial RTW led to later full-time RTW , were also analyzed .


The omnibus test over all 130weeks showed a GROUP * WEEKS interaction effect ( p = .02 ) , indicating differential group developments in RTW , though similarly high at week 130 in both groups with 82.4 % of the IP and 77.9 % of the controls having RTW ( p = .22 ; 2-test ) .


A significant interaction with age led to separate analyses of the younger and older subgroups , indicating a stable pattern of superior RTW only among younger IP ( week 130 : 88.6 % vs. 69.7 % , p = .054 ; 2-test ) .


There was no group difference in relapses into increased degree of sick leave .


Part-time sick leave did not predict a later stable full-time RTW .


The previously reported improvement in RTW with the newly developed workplace-oriented intervention showed a long-term stability only among younger participants .


To assess the effectiveness of nasal saline irrigation in adult patients with chronic rhinosinusitis .


PubMed , EMBASE , the Cochrane Library .


A comprehensive search was performed , and 2 authors independently screened publications .


The design of selected studies was assessed on directness of evidence and risk of bias .


Of 1596 publications , 1 open-label randomized trial with high directness of evidence and moderate risk of bias was included .


In this study , 127 patients were randomly allocated to isotonic nasal saline irrigation or isotonic nasal saline spray , as added to their usual medication .


The mean 20-Item Sinonasal Outcome Test ( SNOT-20 ) scores of those treated with nasal irrigation improved more than those allocated to nasal spray .


While the authors consider an improvement of 16 or more to be clinically meaningful , the changes from baseline in mean SNOT-20 scores of those treated with irrigation ( and the differences with those treated with nasal spray ) at 2 , 4 , and 8 weeks were 12.2 ( difference 5.5 , [ 95 % confidence interval -0.04 to 11.0 ] ) , 16.2 ( difference 8.8 [ 3.2 to 14.4 ] ) , and 15.0 ( difference 6.5 [ 0.4 to 12.6 ] ) , respectively .


Side effects of posttreatment nasal dripping were common but minor and did not lead to discontinuation of treatment .


It should be explained to adult patients with chronic rhinosinusitis that there is limited information on the relative effect of nasal saline irrigation and nasal saline spray on subjective symptom improvement , since there is only 1 trial available with a moderate risk of bias showing limited benefit of irrigation over spray .


The paper presents clinical-radiological research on the impact of the new semi-cement luting agent in the immediately loaded implant-supported restoration on alveolar ridge resorption .


25 patients with a partially edentulous alveolar ridge in the anterior section of the maxilla or mandible were included in the study .


The implants were inserted with the application of traditional burs or with a Piezosurgery device supplied by Mectron .


Taking into account the method of implant bed preparation , the scientific material was divided into two groups .


The implants were loaded immediately with single crown restorations cemented with the Implantlink semi cement application .


The following indices were taken into consideration : pocket depth around implant calculated at four measuring points , marginal alveolar bone loss measured using radio-visiography , the 3-degree Wachtel scale of healing of the soft tissue .


In addition , the presence and possible width or height of any recession around the implants was measured .


The success of the implant treatment was assessed according to the Albrektsson success criteria .


The research results were subjected to statistical analysis .


The results of our study revealed no influence of the Implant-link semi cement on the crestal bone level , regardless of the bone bed preparation technique .


We developed and validated a Patient Satisfaction with Cancer-Related Care ( PSCC ) measure using classical test theory methods .


The present study applied item response theory ( IRT ) analysis to determine item-level psychometric properties , facilitate development of short forms , and inform future applications for the PSCC .


We applied unidimensional IRT models to PSCC data from 1,296 participants ( 73 % female ; 18 to 86 years ) .


An unconstrained graded response model ( GRM ) and a Rasch Model were fitted to estimate indices for model comparison using likelihood ratio ( LR ) test and information criteria .


We computed item and latent trait parameter estimates , category and operating characteristic curves , and tested information curves for the better fitting model .


The GRM fitted the data better than the Rasch Model ( LR = 828 , df = 17 , p < 0.001 ) .


The log-likelihood ( -17,390.38 vs. -17,804.26 ) was larger , and the AIC and BIC were smaller for the GRM compared to the Rash Model ( AIC = 34,960.77 vs. 35,754.73 ; BIC = 35,425.80 vs. 36,131.92 ) .


Item parameter estimates ( IPEs ) showed substantial variation in items ' discriminating power ( 0.94 to 2.18 ) .


Standard errors of the IPEs were small ( threshold parameters mostly around 0.1 ; discrimination parameters 0.1 to 0.2 ) , confirming the precision of the IPEs .


The GRM provides precise IPEs that will enable comparable scores from different subsets of items , and facilitate optimal selections of items to estimate patients ' latent satisfaction level .


Given the large calibration sample , the IPEs can be used in settings with limited resources ( e.g. , smaller samples ) to estimate patients ' satisfaction .


Glutathione ( GSH ) , the most abundant endogenous antioxidant , is a critical regulator of oxidative stress and immune function .


While oral GSH has been shown to be bioavailable in laboratory animal models , its efficacy in humans has not been established .


Our objective was to determine the long-term effectiveness of oral GSH supplementation on body stores of GSH in healthy adults .


A 6-month randomized , double-blinded , placebo-controlled trial of oral GSH ( 250 or 1,000 mg/day ) on GSH levels in blood , erythrocytes , plasma , lymphocytes and exfoliated buccal mucosal cells was conducted in 54 non-smoking adults .


Secondary outcomes on a subset of subjects included a battery of immune markers .


GSH levels in blood increased after 1 , 3 and 6 months versus baseline at both doses .


At 6 months , mean GSH levels increased 30-35 % in erythrocytes , plasma and lymphocytes and 260 % in buccal cells in the high-dose group ( P < 0.05 ) .


GSH levels increased 17 and 29 % in blood and erythrocytes , respectively , in the low-dose group ( P < 0.05 ) .


In most cases , the increases were dose and time dependent , and levels returned to baseline after a 1-month washout period .


A reduction in oxidative stress in both GSH dose groups was indicated by decreases in the oxidized to reduced glutathione ratio in whole blood after 6 months .


Natural killer cytotoxicity increased > twofold in the high-dose group versus placebo ( P < 0.05 ) at 3 months .


These findings show , for the first time , that daily consumption of GSH supplements was effective at increasing body compartment stores of GSH .


To compare femtosecond laser-assisted cataract surgery without the use of ophthalmic viscosurgical device ( OVD ) with standard phacoemulsification using OVD .


This was a prospective , randomized , single-center trial of 37 patients ( 74 eyes ) diagnosed as having significant cataract in both eyes .


Randomly , one eye underwent standard phacoemulsification with OVD ( the OVD group ) ; this group acted as controls .


The other eye was treated with the femtosecond laser ; the subsequent manual part of the procedure was performed without OVD ( non-OVD group ) .


Time of surgery , amount of fluid used during phacoemulsification , central corneal thickness , intraocular pressure , endothelial cell count , and visual acuity were documented over the 6-month follow-up .


There were no major complications and no significant difference in overall surgery time ( non-OVD : 375 81 seconds ; OVD : 362 43 seconds ; P = .713 ) and in the quantity of fluid passing through the eye ( non-OVD : 187 35 mL ; OVD : 186 27 mL ; P = .952 ) between groups .


Endothelial cell loss after 6 months was not significantly different between groups ( non-OVD : -2.4 % ; OVD : -2.7 % ; P = .880 ) .


Central corneal thickness was not different at 1 week postoperatively between groups ( non-OVD : 575 45 m ; OVD : 573 46 m ; P = .820 ) .


Three patients in the OVD group and one patient in the non-OVD group experienced intraocular pressure greater than 25 mm Hg at 1 day postoperatively .


There were no significant differences in corrected distance visual acuity between groups ( logMAR non-OVD : 0.024 ; OVD : 0.038 ; P = .461 ) .


Femtosecond laser-assisted treatment allows the cataract surgeon to perform phacoemulsification and intraocular lens implantation without the use of OVD at no additional risk to the corneal endothelium .


Furthermore , there was a tendency toward fewer increases in intraocular pressure in patients treated with the femtosecond laser .


To evaluate the clinical efficacy and safety of the three therapies of strong stimulation for children peripheral facial palsy so as to deal with the problem on the inactive acceptance of acupuncture in children .


Eighty cases of children peripheral facial palsy were randomized into a moxa stick group ( group A ) and a group with three therapies of strong stimulation ( group B ) .


Baihui ( GV 20 ) , Sibai ( ST 2 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) and the other acupoints were selected in the two groups and stimulated with half-needling technique .


In the group A , 3 moxa sticks were bunched together for surrounding moxibustion over one of Dazhui ( GV 14 ) , Yangbai ( GB 14 ) , Xiaguan ( ST 7 ) and Jiache ( ST 6 ) in each treatment .


In the group B , the strong pricking therapy , strong cupping therapy and strong moxibustion were adopted at the same acupoints as the group A.


The treatment was given twice every day in the first 5 days .


Afterwards , the clinical efficacy was analyzed statistically .


The treatment was kept on for the effective case .


Those with failed effect were transferred to the other group .


Since the 6th day , the treatment was given once every day .


In 15 days , the clinical efficacy was compared between the two groups and House-Brackmann ( H-B ) facial nerve function grade was compared before and after treatment .


In 5 days of treatment , the total effective rate was 94.7 % ( 36/38 ) in the group B , which was better than 52.4 % ( 22/42 ) in the group A , ( P < 0.001 ) .


In 15 days of treatment , the cured rate and the total effective rate in the group B were 67.3 % ( 35/52 ) and 96.2 % ( 50/52 ) , which were better than 9.5 % ( 2/21 ) and 85.7 % ( 18/21 ) in the group A , respectively ( P < 0.001 , P < 0.05 ) .


Additionally , the result of H-B facial nerve function grade in the group B was superior to the group A ( P < 0.001 ) .


The half-needling technique and the three therapies of strong stimulation in combination achieve the superior efficacy on children peripheral facial palsy as compared with the half-needling technique combined with moxa stick therapy .


And the obvious adverse reaction has not been found .


Tofacitinib , an orally administered Janus kinase inhibitor , blocks signaling through - chain-containing cytokines ( interleukins 2 , 4 , 7 , 9 , 15 , and 21 ) .


We performed a phase 2 trial to measure its efficacy in patients with moderate-to-severe active Crohn 's disease .


Patients ( N = 139 ; age , 18 y ) with moderate-to-severe active Crohn 's disease were assigned randomly to groups given 1 mg ( n = 36 ) , 5 mg ( n = 34 ) , or 15 mg ( n = 35 ) tofacitinib or placebo ( n = 34 ) , twice daily for 4 weeks , at 48 centers in 12 countries .


The primary end point was the proportion of clinical responders at week 4 ( decrease from baseline in the Crohn 's Disease Activity Index score of 70 points [ Response-70 ] ) .


Secondary end points included clinical remission ( Crohn 's Disease Activity Index score of < 150 points ) at week4 .


A clinical response was observed in 36 % ( P = .467 ) , 58 % ( P = .466 ) , and 46 % ( P .999 ) of patients given the 1 - , 5 - , and 15-mg doses of tofacitinib , compared with 47 % of patients given placebo .


Clinical remission was observed in 31 % ( P = .417 ) , 24 % ( P = .776 ) , and 14 % ( P = .540 ) of patients given the 1 - , 5 - , and 15-mg doses of tofacitinib , compared with 21 % of patients given placebo .


The 15-mg dose of tofacitinib reduced levels of C-reactive protein and fecal calprotectin from baseline .


Adverse and serious adverse events were similar among groups .


Dose-dependent increases in low - and high-density lipoprotein cholesterol were observed in patients given the 5 - or 15-mg doses of tofacitinib .


There were no significant differences in the percentage of patients with moderate-to-severe active Crohn 's disease who achieved clinical responses ( Response-70 ) or clinical remission after 4 weeks ' administration of tofacitinib ( 1 , 5 , or 15 mg ) or placebo twice daily .


However , a large percentage of patients given placebo achieved Response-70 or remission .


Reductions in C-reactive protein and fecal calprotectin levels among patients given the 15-mg dose of tofacitinib indicate its biologic activity .


ClinicalTrials.gov number : NCT00615199 .


Triple negative breast cancer ( TNBC ) has higher rates of recurrence and distant metastasis , and poorer outcome as compared to non-TNBC .


Aberrant activation of WNT signaling has been detected in TNBC , which might be important for triggering oncogenic conversion of breast epithelial cell .


Therefore , we directed our focus on identifying the WNT ligand and its underlying mechanism in TNBC cells .


We performed large-scale analysis of public microarray data to screen the WNT ligands and the clinical significance of the responsible ligand in TNBC .


WNT5B was identified and its overexpression in TNBC was confirmed by immunohistochemistry staining , Western blot and ELISA .


ShRNA was used to knockdown WNT5B expression ( shWNT5B ) .


Cellular functional alteration with shWNT5B treatment was determined by using wound healing assay , mammosphere assay ; while cell cycle and apoptosis were examined by flowcytometry .


Mitochondrial morphology was photographed by electron microscope .


Biological change of mitochondria was detected by RT-PCR and oxygen consumption assay .


Activation of WNT pathway and its downstream targets were evaluated by liciferase assay , immunohistochemistry staining and immunoblot analysis .


Statistical methods used in the experiments besides microarray analysis was two-tailed t-test .


WNT5B was elevated both in the tumor and the patients ' serum .


Suppression of WNT5B remarkably impaired cell growth , migration and mammosphere formation .


Additionally , G0/G1 cell cycle arrest and caspase-independent apoptosis was observed .


Study of the possible mechanism indicated that these effects occurred through suppression of mitochondrial biogenesis , as evidenced by reduced mitochondrial DNA ( MtDNA ) and compromised oxidative phosphorylation ( OXPHOS ) .


In Vivo and in vitro data uncovered that WNT5B modulated mitochondrial physiology was mediated by MCL1 , which was regulated by WNT / - catenin responsive gene , Myc .


Clinic data analysis revealed that both WNT5B and MCL1 are associated with enhanced metastasis and decreased disease-free survival .


All our findings suggested that WNT5B/MCL1 cascade is critical for TNBC and understanding its regulatory apparatus provided valuable insight into the pathogenesis of the tumor development and the guidance for targeting therapeutics .


Radial head subluxation , also known as ` pulled elbow ' , ` dislocated elbow ' or ` nursemaid 's elbow ' , is one of the most common upper extremity injuries in young children and a common reason to visit Emergency Department ( ED ) .


To compare supination of the wrist followed by flexion of the elbow ( the traditional reduction technique ) to hyperpronation of the wrist in the reduction of radial head subluxations ( nursemaid 's elbow ) maneuvers in children presented to ED with painful pronation and to determine which method is less painful by children .


This prospective randomize study involved a consecutive sampling of children between 1-5 year old who were presented to the ED with painful pronation .


The initial procedure was repeated if baseline functioning did not return 20 minutes after the initial reduction attempt .


Failure of that technique 30 minutes after the initial reduction attempt resulted in a cross-over to the alternate method of reduction .


Datas were analyzed using SPSS for Windows 16.0 .


Mean , standard deviation , independent samples t test , Chi-square test , and paired t test were used in the assessment of pain scores before and after reduction .


When pain scores before and after reduction were compared between groups to determine which technique is less painful by children , no significant difference was found between groups .


It was found that in the reduction of radial head subluxations , the hyperpronation technique is more effective in children who were presented to ED with painful pronation compared with supination-flexion .


However , there was no significant difference between these techniques in terms of pain .


Isomaltulose attenuates postprandial glucose and insulin concentrations compared with sucrose in patients with type 2 diabetes mellitus ( T2DM ) .


However , the mechanism by which isomaltulose limits postprandial hyperglycemia has not been clarified .


The objective was therefore to assess the effects of bolus administration of isomaltulose on glucose metabolism compared with sucrose in T2DM .


In a randomized , double-blind , crossover design , 11 participants with T2DM initially underwent a 3-h euglycemic-hyperinsulinemic ( 0.8 mU kg ( -1 ) min ( -1 ) ) clamp that was subsequently combined with 1 g/kg body wt of an oral ( 13 ) C-enriched isomaltulose or sucrose load .


Hormonal responses and glucose kinetics were analyzed during a 4-h postprandial period .


Compared with sucrose , absorption of isomaltulose was prolonged by 50 min ( P = 0.004 ) .


Mean plasma concentrations of insulin , C-peptide , glucagon , and glucose-dependent insulinotropic peptide were 10-23 % lower ( P < 0.05 ) .


In contrast , glucagon-like peptide 1 ( GLP-1 ) was 64 % higher ( P < 0.001 ) after isomaltulose ingestion , which results in an increased insulin-to-glucagon ratio ( P < 0.001 ) compared with sucrose .


The cumulative amount of systemic glucose appearance was 35 % lower after isomaltulose than after sucrose ( P = 0.003 ) because of the reduction in orally derived and endogenously produced glucose and a higher first-pass splanchnic glucose uptake ( SGU ) .


Insulin action was enhanced after isomaltulose compared with sucrose ( P = 0.013 ) .


Ingestion of slowly absorbed isomaltulose attenuates postprandial hyperglycemia by reducing oral glucose appearance , inhibiting endogenous glucose production ( EGP ) , and increasing SGU compared with ingestion of rapidly absorbed sucrose in patients with T2DM .


In addition , GLP-1 secretion contributes to a beneficial shift in the insulin-to-glucagon ratio , suppression of EGP , and enhancement of SGU after isomaltulose consumption .


This trial was registered at clinicaltrials.gov as NCT01070238 .


Ultrasound guidance may decrease the procedural time for many peripheral nerve blocks compared to nerve stimulation , but these studies have generally excluded obese patients .


This single-blinded randomized clinical trial was designed to compare procedural times and related outcomes for ultrasound - versus nerve stimulation-guided lateral popliteal-sciatic nerve blockade specifically in obese patients .


With Institutional Review Board approval and informed consent , patients with a body mass index greater than 30 kg/m ( 2 ) who were scheduled for foot/ankle surgery and desiring a peripheral nerve block were offered enrollment .


Study patients were randomly assigned to receive a lateral popliteal-sciatic nerve block under either ultrasound or nerve stimulation guidance .


The patient and assessor were blinded to group assignment .


The primary outcome was procedural time in seconds .


Secondary outcomes included number of needle redirections , procedure-related pain , patient satisfaction with the block , success rate , sensory and motor onset times , block duration , and complication rates .


Twenty-four patients were enrolled and completed the study .


All patients had successful nerve blocks .


The mean procedural times ( SD ) were 577 ( 57 ) seconds under nerve stimulation and 206 ( 40 ) seconds with ultrasound guidance ( P < .001 ; 95 % confidence interval for difference , 329-412 seconds ) .


Patients in the ultrasound group had fewer needle redirections and less procedure-related pain , required less opioids , and were more satisfied with their block procedures .


There were no statistically significant differences in other outcomes .


The results of this study show that , for obese patients undergoing lateral popliteal-sciatic nerve blocks , ultrasound guidance reduces the procedural time and procedure-related pain and increases patient satisfaction compared to nerve stimulation while providing similar block characteristics .


To determine the extent that social variables influence cognitive development of very low birth weight ( VLBW ) infants across the preschool years .


Participants were VLBW ( 500-1250 g ) children enrolled in the Caffeine for Apnea of Prematurity randomized trial between 1999 and 2004 .


We investigated the relationships between 4 potential social advantages : higher maternal education , higher paternal education , caregiver employment , and 2 biologic parents in the same home -- and gain in cognitive scores .


Cognitive assessments were performed at the corrected ages of 18 months ( Mental Development Index score on the Bayley Scales of Infant Development II ) and 5 years ( Full Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence III ) .


Cognitive gain was computed by subtracting each individual 18-month Mental Development Index score from the corresponding Full Scale IQ at 5 years .


Data were available for 1347 children .


Mean ( SD ) cognitive scores were 90.8 ( 15.7 ) at 18 months and 98.9 ( 14.5 ) at 5 years .


Multivariable regression showed that higher maternal education , higher paternal education , and caregiver employment had independent and additive effects of similar size on cognitive gain ( P < .001 ) ; the mean cognitive gain between 18 months and 5 years increased by 3.6 points in the presence of each of these advantages .


When all 3 were present , cognitive scores improved on average by 10.9 points compared with children without any of these advantages .


In VLBW children , a count of 3 social advantages strongly predicts gains in cognitive scores across the preschool years .


Detectable levels of troponins are often found in serum of patients with atrial fibrillation ( AF ) , and recent reports suggest that Tn concentrations are independently related to patient prognosis .


We hypothesized that treatment with common rate-reducing drugs might lower the levels of cardiac troponin T ( TnT ) in patients with permanent AF .


We also wanted to investigate whether the different drugs would impact the Tn levels differently .


Sixty patients were included ( mean age 71 9 years , 18 women ) in this randomized crossover study .


All patients had stable , permanent AF without ischemic heart disease or congestive heart failure .


Diltiazem 360 mg , verapamil 240 mg , metoprolol 100 mg , and carvedilol 25 mg were administered once daily for 3 weeks , in a randomized sequence .


At baseline and on the last day of each treatment period , TnT concentrations were measured at rest and after a maximal exercise test .


TnT was detectable in all patients .


In 22 % of the patients , TnT concentrations were above the threshold normally used for diagnosing myocardial infarction .


All drugs reduced the levels of TnT significantly compared with baseline ( P < 0.001 for all ) , but there were no significant differences between the treatments .


Levels of TnT increased significantly in response to exercise testing ( P < 0.001 for all ) .


Elevated TnT was demonstrated in a large proportion of stable patients with permanent AF without ischemic heart disease .


A moderate reduction of heart rate by the study drugs was associated with a significant reduction in levels of TnT .


Pain and depression are prevalent and treatable symptoms among patients with cancer , yet they are often undetected and undertreated .


The Indiana Cancer Pain and Depression ( INCPAD ) trial demonstrated that telecare management can improve pain and depression outcomes .


This article investigates the incremental cost effectiveness of the INCPAD intervention .


The INCPAD trial was conducted in 16 community-based urban and rural oncology practices in Indiana .


Of the 405 participants , 202 were randomized to the intervention group and 203 to the usual-care group .


Intervention costs were determined , and effectiveness outcomes were depression-free days and quality-adjusted life years .


The intervention group was associated with a yearly increase of 60.3 depression-free days ( S.E. = 15.4 ; P < 0.01 ) and an increase of between 0.033 and 0.066 quality-adjusted life years compared to the usual care group .


Total cost of the intervention per patient was US$ 1189 , which included physician , nurse care manager and automated monitoring set-up and maintenance costs .


Incremental cost per depression-free day was US$ 19.72 , which yields a range of US$ 18,018 to US$ 36,035 per quality-adjusted life year when converted to that metric .


When measured directly , the incremental cost per quality-adjusted life year ranged from US$ 10,826 based on the modified EQ-5D to US$ 73,286.92 based on the SF-12 .


Centralized telecare management , coupled with automated symptom monitoring , appears to be a cost effective intervention for managing pain and depression in cancer patients .


The administration of uterotonic agents during cesarean delivery is highly variable .


The authors hypothesized a `` rule of threes '' algorithm , featuring oxytocin 3 IU , timed uterine tone evaluations , and a systematic approach to alternative uterotonic agents , would reduce the oxytocin dose required to obtain adequate uterine tone .


Sixty women undergoing elective cesarean delivery were randomized to receive a low-dose bolus or continuous infusion of oxytocin .


To blind participants , the rule group simultaneously received intravenous oxytocin ( 3 IU/3 ml ) and a `` wide-open '' infusion of 0.9 % normal saline ( 500 ml ) ; the standard care group received intravenous 0.9 % normal saline ( 3 ml ) and a `` wide-open '' infusion of oxytocin ( 30 IU in 0.9 % normal saline/500 ml ) .


Uterine tone was assessed at 3 , 6 , 9 , and 12 min , and if inadequate , additional uterotonic agents were administered .


Uterine tone , total dose and timing of uterotonic agent use , maternal hemodynamics , side effects , and blood loss were recorded .


Adequate uterine tone was achieved with lower oxytocin doses in the rule versus standard care group ( mean , 4.0 vs. 8.4 IU ; point estimate of the difference , 4.4 1.0 IU ; 95 % CI , 2.60 to 6.15 ; P < 0.0001 ) .


No additional oxytocin or alternative uterotonic agents were needed in either group after 6 min .


No differences in the uterine tone , maternal hemodynamics , side effects , or blood loss were observed .


A `` rule of threes '' algorithm using oxytocin 3 IU results in lower oxytocin doses when compared with continuous-infusion oxytocin in women undergoing elective cesarean delivery .


Glucagon-like peptide-1 ( GLP-1 ) and the insulin-like growth factor ( IGF ) system are important factors in metabolic regulation and cellular growth .


Interactions between the systems exist but these are vaguely explored and only in vitro , where GLP-1 has been reported to stimulate IGF-binding protein 1 ( IGFBP-1 ) .


This study , therefore , aimed to elucidate the effects of GLP-1 on IGF-I and the IGFBPs , which regulate IGF-I bioactivity .


We investigated the effects of a 2-hour intravenous GLP-1 infusion on the IGF system in 12 overnight fasted healthy humans , using a randomized , double-blinded , cross-over study design .


Serum samples were assessed for immunoreactive levels of IGF-I , IGFBP-1 and -2 as well as for bioactive IGF-I , which was determined by a cell-based IGF-I kinase receptor activation assay .


GLP-1 infusion markedly increased insulin levels ( p < 0.0001 ) , reduced IGFBP-1 levels ( p = 0.02 ) , and tended to increase IGF-I bioactivity ( p = 0.06 ) .


There were no significant changes in IGFBP-2 or immunoreactive IGF-I levels .


In this short-term study , GLP-1 reduced IGFBP-1 levels in vivo and tended to increase IGF-I bioactivity .


The IGFBP-1 outcome is opposite to the in vitro situation , hereby demonstrating that in vivo the ability of GLP-1 to stimulate insulin and hereby suppress IGFBP-1 outweighs any direct stimulatory effects of GLP-1 on IGFBP-1 .


Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs .


We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population .


We also explored whether reductions in glycated hemoglobin ( HbA1c ) will be more marked in minority persons .


We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged 18years and whose last measured HbA1c was 7.5 % ( 58mmol/mol ) .


Participants were randomized to : 1 ) a Chronic Disease Self-Management Program ( CDSMP ; n = 101 ) ; 2 ) a diabetes self-care software on a personal digital assistant ( PDA ; n = 81 ) ; 3 ) a combination of interventions ( CDSMP + PDA ; n = 99 ) ; or 4 ) usual care ( control ; n = 95 ) .


Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice .


The primary outcome was change in HbA1c from randomization to 12months .


Data were analyzed using a multilevel statistical model .


Average baseline HbA1c in the CDSMP , PDA , CDSMP + PDA , and control arms were 9.4 % , 9.3 % , 9.2 % , and 9.2 % , respectively .


HbA1c reductions at 12months for the groups averaged 1.1 % , 0.7 % , 1.1 % , and 0.7 % , respectively and did not differ significantly from baseline based on the model ( P = .771 ) .


Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts ( P < .004 ) , no other significant differences were observed in participants ' diabetes self-care activities .


Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups .


Although behavioral and technological interventions can result in some modest improvements in glycemic control , these interventions did not fare significantly better than usual care in achieving glycemic control .


More research is needed to understand how these interventions can be most effective in clinical practice .


The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control .


Clinicaltrials.gov Identifier : NCT01221090 .


Immunological non-responders ( INRs ) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression .


We assessed immune reconstitution profile upon intensification with maraviroc in INRs .


We designed a multi-centric , randomized , parallel , open label , phase 4 superiority trial .


We enrolled 97 patients on HAART with CD4 + < 200/L and/or CD4 + recovery 25 % and HIV-RNA < 50 cp/mL .


Patients were randomized 1:1 to HAART + maraviroc or continued HAART .


CD4 + and CD8 + CD45 + RA/RO , Ki67 expression and plasma IL-7 were quantified at W0 , W12 and W48 .


By W48 both groups displayed a CD4 increase without a significant inter-group difference .


A statistically significant change in CD8 favored patients in arm HAART + maraviroc versus HAART at W12 ( p = .009 ) and W48 ( p = .025 ) .


The CD4 > 200/L and CD4 > 200/L + CD4 gain 25 % end-points were not satisfied at W12 ( p = .24 and p = .619 ) nor at W48 ( p = .076 and p = .236 ) .


Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation .


Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 ( p = .01 ) , and a trend in temporary reduction in activated HLA-DR + CD38 + CD4 + by W12 ( p = .06 ) that was not maintained at W48 .


Maraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool , but did substantially expand CD8 .


It resulted in a low rate of treatment discontinuations .


ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858 .


Matrix - carboxyglutamate protein is an inhibitor of cardiovascular calcification .


The objective of this substudy of the Aortic Stenosis Progression Observation : Measuring Effects of Rosuvastatin ( ASTRONOMER ) trial was to examine the relationship between total ( ie , carboxylated [ active ] form + uncarboxylated [ inactive ] form ) circulating desphosphorylated matrix - carboxyglutamate protein ( dpMGP ) level and the progression rate of aortic stenosis ( AS ) .


Among the patients included in the ASTRONOMER trial , 215 patients had measures of baseline circulating total dpMGP level and an echocardiographic follow-up ( mean follow-up : 3.5 1.3 years ) .


Progression of AS was assessed according to the measurement of the annualized increase in peak aortic jet velocity .


In the whole cohort , baseline dpMGP level was associated with faster progression rate of peak aortic jet velocity ( r = 0.16 ; P = 0.02 ) in individual analysis but not in multivariable analysis ( P = 0.40 ) .


However , there was a significant interaction ( P = 0.03 ) between dpMGP level and age , with respect to the effect on AS progression .


After dichotomization according to median value of age ( ie , 57 years old ) , total dpMGP level was associated with faster AS progression rate ( r = 0.24 ; P = 0.008 ) in the younger patients , and this association remained significant in multivariable analysis ( P = 0.04 ) , but not in the older ones .


The independent correlates of dpMGP level were fasting glucose ( P = 0.009 ) and oxidized low-density lipoprotein ( P = 0.01 ) .


This is the first prospective study to demonstrate a relationship between increased circulating levels of total dpMGP and faster progression rate of AS in younger individuals .


Future studies are needed to determine if dpMGP is simply a marker or a contributing factor to ectopic mineralization of aortic valve .


Endoscopic variceal ligation ( EVL ) is recommended to treat esophageal varices ( EV ) in cirrhosis and portal hypertension .


A program of endoscopic surveillance is not clearly established .


The aim of this prospective randomized trial was to assess the most effective timing of endoscopic monitoring after variceal eradication and its impact on the patient 's outcome and on the costs .


A hundred and two cirrhotic patients with esophageal varices treated by EVL were evaluated .


After variceal eradication patients were randomized to receive first endoscopic control at 3 ( Group 1 ) and 6 ( Group 2 ) months respectively .


Variceal obliteration was achieved in all patients .


Variceal recurrence was observed in 28 cases at the first control ( 29.1 % ) without difference between the two groups ( 32 % vs 29 % in group 1 and 2 respectively , p = 0.75 ) .


The incidence of large varices is similar in the two groups ( 33 % vs 38 % respectively ) .


Using a multivariate analysis , medical therapy with B blockers was the only independent predictor of lowest risk of variceal recurrence [ OR 2.30 , 95 % CI ( 1.68-3 .26 ) ] .


Bleeding related to recurrent varices occurred in 3.1 % of cases and was associated with portal thrombosis .


Child Pugh score 8 was the only predictor of mortality ( p = 0.0002 ) .


Recurrence of varices after banding ligation is not rare but it is associated with a low risk of variceal progression and bleeding .


Accordingly , a first endoscopic control at 6 months after variceal eradication associated with a good risk stratification might be a cost-effective strategy of monitoring .


To determine the incidence and risk factors for readmission to the intensive care unit ( ICU ) among preterm infants who required mechanical ventilation at birth .


We studied preterm newborns ( birth weight 500-1250 g ) who required mechanical ventilation at birth and were enrolled in a multicenter trial of inhaled nitric oxide therapy .


Patients were assessed up to 4.5 years of age via annual in-person evaluations and structured telephone interviews .


Univariate and multivariable analyses of baseline and birth hospitalization predictors of ICU readmission were performed .


Of 512 subjects providing follow-up data , 58 % were readmitted to the hospital ( 51 % of these had multiple readmissions , averaging 3.9 readmissions per subject ) , 19 % were readmitted to an ICU , and 12 % required additional mechanical ventilation support .


In univariate analyses , ICU readmission was more common among male subjects ( OR 2.01 ; 95 % CI 1.27-3 .18 ) , infants with grade 3-4 intracranial hemorrhage ( OR 2.13 ; 95 % CI 1.23-3 .69 ) , increasing duration of birth hospitalization ( OR 1.01 per day ; 95 % CI 1.00-1 .02 ) , and prolonged oxygen therapy ( OR 1.01 per day ; 95 % CI 1.00-1 .01 ) .


In the first year after birth hospitalization , children readmitted to an ICU incurred greater health care costs ( median $ 69,700 vs $ 30,200 for subjects admitted to the ward and $ 9600 for subjects never admitted ) .


Small preterm infants who were mechanically ventilated at birth have substantial risk for readmission to an ICU and late mechanical ventilation , require extensive health care resources , and incur high treatment costs .


Although often investigated in locally advanced esophageal cancer ( EC ) , the impact of neoadjuvant chemoradiotherapy ( NCRT ) in early stages is unknown .


The aim of this multicenter randomized phase III trial was to assess whether NCRT improves outcomes for patients with stage I or II EC .


The primary end point was overall survival .


Secondary end points were disease-free survival , postoperative morbidity , in-hospital mortality , R0 resection rate , and prognostic factor identification .


From June 2000 to June 2009 , 195 patients in 30 centers were randomly assigned to surgery alone ( group S ; n = 97 ) or NCRT followed by surgery ( group CRT ; n = 98 ) .


CRT protocol was 45 Gy in 25 fractions over 5 weeks with two courses of concomitant chemotherapy composed of fluorouracil 800 mg/m ( 2 ) and cisplatin 75 mg/m ( 2 ) .


We report the long-term results of the final analysis , after a median follow-up of 93.6 months .


Pretreatment disease was stage I in 19.0 % , IIA in 53.3 % , and IIB in 27.7 % of patients .


For group CRT compared with group S , R0 resection rate was 93.8 % versus 92.1 % ( P = .749 ) , with 3-year overall survival rate of 47.5 % versus 53.0 % ( hazard ratio [ HR ] , 0.99 ; 95 % CI , 0.69 to 1.40 ; P = .94 ) and postoperative mortality rate of 11.1 % versus 3.4 % ( P = .049 ) , respectively .


Because interim analysis of the primary end point revealed an improbability of demonstrating the superiority of either treatment arm ( HR , 1.09 ; 95 % CI , 0.75 to 1.59 ; P = .66 ) , the trial was stopped for anticipated futility .


Compared with surgery alone , NCRT with cisplatin plus fluorouracil does not improve R0 resection rate or survival but enhances postoperative mortality in patients with stage I or II EC .


To examine the long-term safety of oral ospemifene , a non-estrogen tissue-selective estrogen agonist/antagonist , for the treatment of moderate to severe dyspareunia , a symptom of vulvar and vaginal atrophy ( VVA ) due to menopause .


This multicenter , long-term , open-label , safety extension study was conducted in women without a uterus aged 40-80 years ( N = 301 ) who received oral ospemifene 60 mg/day for 52 weeks .


Participants either continued their 60-mg/day ospemifene dose from the initial 12-week pivotal efficacy study or switched from blinded placebo or ospemifene 30 mg/day to open-label ospemifene 60 mg/day .


The 52-week open-label extension period plus initial 12-week treatment period totaled up to 64 weeks of ospemifene exposure .


A 4-week posttreatment follow-up ensued ( 68 weeks total ) .


Safety assessments included adverse events , laboratory studies , physical and gynecologic examination , vital signs , breast palpation , and mammography .


Most treatment-emergent adverse events ( TEAEs ) during the extension study were mild or moderate in severity .


The most common TEAE related to study drug was hot flushes ( 10 % ; leading to discontinuation for 2 % of patients ) .


One serious TEAE , a non-ST-elevation myocardial infarction in a patient with pre-existing cardiac disease , was considered possibly related to study medication .


One mild breast-related TEAE , considered unrelated to study drug , was ongoing at study completion .


There were no instances of pelvic organ prolapse , incontinence , venous thromboembolism , fractures , breast cancers or death .


No clinically significant adverse changes were observed in other safety parameters .


Ospemifene is clinically safe and generally well tolerated in postmenopausal patients with dyspareunia , a symptom of VVA .


Although the need for hand hygiene ( HH ) is generally accepted , studies continue to document inadequate compliance .


Medical students are taught about the importance of HH to prevent nosocomial infections , and receive training in the correct procedures for HH .


However , personality traits ( social orientation and achievement orientation ) may influence HH compliance .


People with high social orientation feel socially responsible and act cooperatively , and people with high achievement orientation are ambitious and competitive .


To evaluate the relationship between HH compliance and personality traits of medical students .


The HH compliance of 155 students was observed during objective standardized clinical examinations ( OSCEs ) .


Social orientation and achievement orientation were measured using the corresponding scales of the Freiburg Personality Inventory - Revised .


Social orientation did not differ between students with high HH compliance and students with low HH compliance [ F ( 1 ) = 3.87 , P = 0.052 , ( 2 ) = 0.045 ] .


For achievement orientation , a moderate effect was found between low and high HH compliance [ F ( 1 ) = 11.242 , P = 0.001 , ( 2 ) = 0.119 ] , and students with high HH compliance were found to be more achievement orientated than students with low HH compliance .


Achievement orientation plays a major role during OSCEs , while social orientation is less emphasized .


To the authors ' knowledge , this is the first study to show that HH compliance is associated with achievement orientation in achievement situations .


The objective of this study was to explore the effects of hypotonic and isotonic oral mannitol on intestinal distention and fluorine-18 fluorodeoxyglucose ( ( 18 ) F-FDG ) intake in PET/computed tomography ( CT ) imaging .


A total of 124 patients without gastrointestinal disease were evaluated with PET/CT imaging and divided into four groups using a random number table .


Group 1 drank plain water , group 2 drank 2.5 % mannitol , group 3 drank 2.5 % mannitol and also received 10mg of scopolamine butylbromide , and group 4 drank 2.5 % mannitol and also received 20mg of scopolamine butylbromide .


The patients in each group underwent PET/CT imaging 50min after ( 18 ) F-FDG injection .


In these groups , differences such as age , sex , disease distribution , oral liquid amount , and adverse reactions were compared .


Gastrointestinal distention and F-FDG intake were analyzed by two experts in nuclear medicine by visual observation .


Data were statistically analyzed using a rank-sum test , RC contingency table , one-way analysis of variance , and a paired t-test .


There were no significant differences in blood glucose levels after oral administration of 2.5 % mannitol ( t = 0.62 , P > 0.05 ) .


Gastrointestinal distention of patients in groups 2 , 3 , and 4 was superior to that of patients in group 1 ( P < 0.05 / 6 ) .


In addition to the sigmoid colon and rectum , ( 18 ) F-FDG intake in each part of the gastrointestinal tract in groups 2 , 3 , and 4 was less than that in group 1 ( P < 0.05 / 6 ) .


Patients in group 4 experienced significantly more adverse reactions compared with patients in the other groups ( P < 0.05 ) .


Oral negative contrast agent and hypotonic bowel preparation decreased the physiological intake of ( 18 ) F-FDG , increased the distention of the gastrointestinal tract , and thus improved the image quality .


The present study investigated whether prochlorperazine affects vestibulo-ocular reflex ( VOR ) and vestibulo-perceptual function .


We studied 12 healthy nave subjects 3 h after a single dose of oral prochlorperazine 5 mg in a randomised , placebo-controlled , double-blind , crossover study in healthy young subjects .


Two rotational tests in yaw were used : ( 1 ) a threshold task investigating perceptual motion detection and nystagmic thresholds ( acceleration steps of 0.5 / s ( 2 ) ) and ( 2 ) suprathreshold responses to velocity steps of 90/s in which vestibulo-ocular and vestibuloperceptual time constants of decay , as well as VOR gain , were measured .


Prochlorperazine had no effect upon any measure of nystagmic or perceptual vestibular function compared to placebo .


This lack of effects on vestibular-mediated motion perception suggests that the drug is likely to act more as an anti-emetic than as an antivertiginous agent .


Craving is viewed as a core feature of substance use disorders and has been shown to predict future drug use , particularly over the short term .


Accordingly , craving is often assessed in treatment settings as a marker of risk for subsequent drug use .


The identification of the briefest measure that maintains predictive validity is of particular value for both clinical and research settings to minimize assessment burden while maintaining utility for the prediction of use .


Data from a multi-site clinical trial of treatment for prescription opioid dependence were examined to evaluate whether a brief , 3-item craving scale administered each week predicted urine-confirmed self report of prescription opioid use in the subsequent week .


Logistic regression models examining the association between craving and presence or absence of opioid use in the following week were conducted , controlling for opioid use in the previous week , treatment condition , and lifetime history of heroin use .


Greater craving was associated with a higher odds of prescription opioid use in the following week .


For each one-unit increase on this 10-point scale , the odds of using opioids in the subsequent week was 17 % higher .


In addition to an item assessing urges , items assessing cue-induced craving and perceived likelihood of relapse in an environment where drugs were previously used contributed uniquely to this association .


A brief measure of prescription opioid craving predicted prescription opioid use among individuals in treatment .


This measure offers an efficient strategy to inform the assessment of risk for use in this population .


Ciclosporin and MTX are used in idiopathic inflammatory myopathies ( DM and PM ) when patients incompletely respond to glucocorticoids .


Their effectiveness is unproved in randomized controlled trials ( RCTs ) .


We evaluated their benefits in a placebo-controlled factorial RCT .


A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone , MTX ( 15-25 mg weekly ) plus steroids , ciclosporin ( 1-5 mg/kg/day ) plus steroids and all three treatments .


It enrolled adults with myositis ( by Bohan and Peter criteria ) with active disease receiving corticosteroids .


A total of 359 patients were screened and 58 randomized .


Of the latter , 37 patients completed 12 months of treatment , 7 were lost to follow-up and 14 discontinued treatment .


Patients completing 12 months of treatment showed significant improvement ( P < 0.001 on paired t-tests ) in manual muscle testing ( 14 % change ) , walking time ( 22 % change ) and function ( 9 % change ) .


Intention to treat and completer analyses indicated that ciclosporin monotherapy , MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo .


Neither MTX nor ciclosporin ( by themselves or in combination ) improved clinical features in myositis patients who had incompletely responded to glucocorticoids .


International Standard Randomized Controlled Trial Number Register ; http://www.controlled-trials.com/; ISRCTN40085050 .


To analyze the underlying risk factors in patients with nonarteritic central retinal artery occlusion ( CRAO ) in a well-defined and homogenous group of patients enrolled in the European Assessment Group for Lysis in the Eye ( EAGLE ) study .


Analysis of the cardiovascular risk factors in a prospective , randomized clinical trial .


Seventy-seven EAGLE patients with nonarteritic CRAO .


Analysis of vascular risk factors and underlying diseases detected by questionnaire and standardized physical examination within 1 month after occlusion .


The standardized physical examination included carotid Doppler ultrasonography , echocardiography , electrocardiography , blood pressure monitoring , pulse rate , urine analysis , body mass index analysis , and laboratory tests .


Seventy-seven of 84 patients had complete datasets for analysis .


Fifty-two ( 67 % ) patients had cardiovascular risk factors in their medical history , and comprehensive phenotyping identified at least 1 new risk factor in 60 patients ( 78 % ; 95 % confidence interval , 67 % -87 % ) .


Thirty-one ( 40 % ) had carotid artery stenosis of at least 70 % .


Eleven patients experienced a stroke , 5 of those within 4 weeks after the CRAO occurred .


Arterial hypertension was found in 56 ( 73 % ) patients and was newly diagnosed in 12 ( 16 % ) study participants .


Cardiac diseases were also highly prevalent ( 22 % coronary artery disease , 20 % atrial fibrillation , and 17 % valvular heart disease ) .


Previously undiagnosed vascular risk factors were found in 78 % of all CRAO patients .


The most meaningful risk factor was ipsilateral carotid artery stenosis .


A comprehensive and prompt diagnostic work-up is mandatory for all CRAO patients .


To evaluate the effectiveness of electrical stimulation of the posterior tibialis nerve in men with neurogenic overactive bladder secondary to ischemic stroke at 45 days and 12 months after treatment .


We studied 24 patients older than 18 years , with ischemic stroke that occurred between 6 months and 3 years previously and with no prior urinary symptoms .


These patients were randomly allocated to receive electrical stimulation of the posterior tibialis nerve twice weekly for 6 weeks ( treatment group , n = 12 ) or general advice and stretching sessions 1 to 3 times monthly for 6 weeks ( control group , n = 12 ) .


Each session lasted 30 minutes in both groups .


The primary outcomes were reduction in urinary frequency , reduction in urinary urgency , and overall improvement in voiding diary variables .


Patients in the electrical stimulation group , in relation to baseline and to control group , experienced improvement in urinary symptoms , reducing urinary urgency and frequency , and reported subjective improvement after treatment .


This effect persisted after 12 months of follow-up .


The patients with lesion in right hemisphere , advanced age , and with higher body mass index presented more chance to develop urinary symptoms .


Electrical stimulation of the posterior tibialis nerve is a safe and effective option for the treatment of poststroke neurogenic overactive bladder in men , reducing urinary frequency and urgency .


The aim of this study was to evaluate whether an iron-fortified formula with a concentration of lactoferrin would significantly improve the hematologic indexes and iron status in term infants compared with those same values in infants fed an iron-fortified formula without lactoferrin .


In this prospective , multicenter , controlled intervention study , 260 infants ages 4 to 6mo were selected from six maternal and children 's health care hospitals in the area .


All infants were divided into two groups with the sequence of outpatient : lactoferrin-fortified formula milk group ( fortified group , FG , containing lactoferrin 38mg/100g milk and iron element 4mg/100g milk ) and no lactoferrin fortified milk ( control group , CG , containing lactoferrin 0mg/100g milk and iron element 4mg/100g milk ) for 3mo .


The levels of weight , height , and head circumference and the concentration of hemoglobin ( Hb ) , serum ferritin ( SF ) , and serum transferring receptor ( sTfR ) were measured and sTfR-SF index ( TFR-F index ) , total body iron content ( TBIC ) and low height for age ( HAZ ) , low weight for age ( WAZ ) , and low weight for height ( WHZ ) were computed before and after the intervention , respectively .


In all , 213 ( 115 in FG and 98 in CG ) infants completed the intervention trial and all measurements of biochemical indicators .


There were no significant differences in the average amount of daily intake of formula milk ( 94.39.8 g versus 88.28.7 gfor FG and CG ; P > 0.05 ) and iron element ( 3.80.4 mg versus 3.70.6 mg for FG and CG ; P > 0.05 ) .


The average amount of daily intake of lactoferrin for infants in FG group was 35.83.7 mg .


The levels of weight , WAZ , WHZ , Hb , SF , TFR-F index , and TBIC after intervention of infants in FG were all significantly higher than those of infants in CG weight , 8723245g versus 8558214g ; WAZ , 1.020.31 versus 0.440.18 ; WHZ , 0.980.31 versus 0.410.12 ; Hb , 125.515.4 g/L versus 116.913.1 g/L ; SF , 44.717.2 g/L versus 31.618.4 g/L ; TFR-F index , 1.880.41 versus 1.260.39 ; TBIC , 6.120.78 mg/kg versus 5.260.55 mg/kg for FG and CG ; P < 0.05 ) , but significantly lower ( P < 0.05 ) for the prevalence of anemia ( 4.1 % versus 7.5 % ) , iron deficiency ( 13.9 % versus 24.4 % ) , and iron-deficient anemia ( 1.7 % versus 6.1 % ) .


When infants who were exclusively breastfed were supplemented with lactoferrin-fortified milk , significant increases in TBIC and iron absorption in the intestine were seen .


Homecare re-ablement services have been developed by local authorities in England in response to the government agenda for health and social care .


These services aim to optimize users ' independence and ability to cope at home , and reduce the need for ongoing health and social care services .


However , there is currently limited evidence and guidance regarding the optimum configuration and delivery of re-ablement services .


In particular , the impact of occupational therapy input on service user outcomes has been highlighted as a specific research priority .


This feasibility randomized controlled trial ( RCT ) will recruit 50 people from one local authority led homecare re-ablement service in England .


Those who provide informed consent will be randomized to receive either usual homecare re-ablement ( without routine occupational therapy input ) or usual homecare re-ablement plus an enhanced program targeted at activities of daily living ( ADL ) , delivered by an occupational therapist .


The primary aim of this study is to assess the feasibility of conducting a further , powered study .


The participant outcomes assessed will be independence in personal and extended ADL , health and social care-related quality of life , number of care support hours , falls , acute and residential admissions and use of health and social care services .


These will be assessed at two weeks , three months and six months post-discharge from the re-ablement service .


To our knowledge , this is the first RCT of occupational therapy in homecare re-ablement services .


The results of this study will lay the foundations for a further powered study .


The findings will be relevant to researchers , clinicians , commissioners and users of adult social care services .


Current Controlled Trials registration number : ISRCTN21710246 ( registered on 31March 2014 ) .


Patients usually suffer significant pain after lumbar laminectomy .


Wound infiltration with local anesthetics is a useful method for postoperative pain control .


Our aim was to compare the efficacies of preemptive wound infiltration with bupivacaine and levobupivacaine .


60 patients were randomized three groups as follows : Group L wound infiltration with 20 mL 0.25 % levobupivacaine and 40 mg methylprednisolone just before wound closure ; Group B wound infiltration with 20 mL 0.25 % bupivacaine and 40 mg methylprednisolone before closure ; Group C had this region infiltrated with 20 ml physiological saline .


Demographic data , vital signs , postoperative pain scores and morphine usage were recorded .


First analgesic requirement time was significantly shorter in the control group compared to other two groups ( p < 0.001 ) .


Group B had the lowest cumulative morphine consumption at the end of 24 hours within 0-4 , 4-12 and 12-24 hours time intervals and the values were not significant when compared with Group L , however the consumption of both groups was significantly lower compared to the control group ( p < 0.001 ) .


Our data suggest that preoperative infiltration of the wound site with bupivacaine or levobupivacaine provides similarly effective pain control with reduced opiate dose after unilateral lumbar laminectomy .


To examine the impact of night-shift duration ( 9 hours or > 9 hours ) on efficacy and tolerability of armodafinil in patients with shift work disorder ( SWD ) .


This was a post hoc analysis of a 6 week , multicenter , randomized , double-blind , placebo-controlled , parallel-group study .


Shift workers with diagnosed SWD and late-in-shift sleepiness ( between 4am and 8am , including the commute home ) received armodafinil 150mg or placebo before their night shift .


Proportion of patients with at least minimal improvement in late-in-shift sleepiness , late-in-shift Clinical Global Impressions-Change ( CGI-C ) rating and Karolinska Sleepiness Scale ( KSS ) , as well as overall Global Assessment of Functioning ( GAF ) scale and modified Sheehan Disability Scale ( SDS-M ) , were assessed at baseline and final visit .


Of the 383 patients enrolled , 279 ( 73 % ) worked shifts 9 hours and 104 ( 27 % ) worked shifts > 9 hours .


A greater percentage of patients receiving armodafinil had at least minimal improvement in late-in-shift CGI-C ( 9 hours : 78 % vs 60 % , P = 0.0017 ; > 9 hours : 77 % vs 46 % , P = 0.0020 ) regardless of shift duration .


Armodafinil patients also demonstrated significantly greater improvements in GAF score ( 9 hours : 9.5 vs 5.4 , P < 0.0001 ; > 9 hours : 9.6 vs 4.3 , P = 0.0019 ) and KSS score ( 9 hours : -2.9 vs -1.9 , P = 0.0002 ; > 9 hours : -2.8 vs -1.6 , P = 0.00 28 ) .


Improvement in SDS-M composite score was significantly greater for armodafinil patients working > 9 hours ( -6.8 vs -2.7 , P = 0.0086 ) .


Headache was the most frequent adverse event in all treatment groups .


Patients receiving armodafinil had significantly greater improvements in late-in-shift clinical condition and in wakefulness and overall global functioning than did placebo-treated patients , regardless of shift duration .


Prospectively designed , randomized clinical trials that include objective measures of sleepiness are needed to support these findings .


Cognitive Behaviour Therapy for Insomnia ( CBT-I ) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia .


CBT-I also lowers levels of depression in this group .


However , it is not known if targeting insomnia using CBT-I will lower depressive symptoms , and thus reduce the risk of major depressive episode onset , in those specifically at risk for depression .


Therefore , this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression .


A sample of 1,600 community-dwelling adults ( aged 18-64 ) , who screen positive for both subclinical levels of depressive symptoms and insomnia , will be recruited via various media and randomised to either a 9-week online insomnia treatment programme , Sleep Healthy Using The internet ( SHUTi ) , or an online attention-matched control group ( HealthWatch ) .


The primary outcome variable will be depression symptom levels at the 6-month post-intervention on the Patient Heath Questionnaire-9 ( PHQ-9 ) .


A secondary outcome will be onset of major depressive episodes assessed at the 6-month post-intervention using ` current ' and ` time from intervention ' criteria from the Mini International Neuropsychiatric Interview .


This trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression .


If effective , online provision of a depression prevention programme will facilitate dissemination .


Australian New Zealand Clinical Trials Registry ( ANZCTR ) , Registration number : ACTRN12611000121965 .


Blood hemoglobin can be monitored continuously and noninvasively with a noninvasive spectrophotometric sensor ( Masimo SpHb ) .


The perfusion index ( PI ) of the finger is directly related to the clinical accuracy of SpHb .


We evaluated those variables that influence PI without the influences of surgery and anesthesia .


Based on our past studies , 12 awake adult volunteers were studied .


A SpHb sensor was attached to the same finger of each hand .


The temperature of each finger was measured via a skin surface probe .


A digital nerve block ( DNB ) was performed with 1 % lidocaine on one finger and 0.25 % bupivacaine on the other finger of the opposite hand .


SpHb , PI , and finger temperature were monitored continuously 30 minutes before and 3 to 4 hours after placement of the DNB .


A random effects spline regression was used to flexibly model the outcomes before and after the DNB and to compare the effects of lidocaine and bupivacaine .


The DNBs increased the PI for both lidocaine and bupivacaine ( P < 0.0001 ) and finger temperature from both lidocaine ( P < 0.0001 ) and bupivacaine ( P = 0.02 ) .


The duration of action of bupivacaine was markedly longer than that of lidocaine ( P < 0.0001 ) .


Between 45 and 75 minutes after insertion of the DNB , the PI with bupivacaine was substantially higher than that of lidocaine .


The PI was directly related to changes in finger temperature and SpHb .


During this time interval , 11 of the 12 volunteers receiving bupivacaine descriptively had increases in finger temperature ranging from no change to 6.1 C.


In contrast , only 6 of the 12 lidocaine volunteers had increases in finger temperature ranging from no change to 4C .


Changes in PI were directly correlated with SpHb values ( correlation coefficient = 0.7 ) .


A DNB increases PI and finger temperature .


These increases lasted 2 to 3 hours longer with bupivacaine than lidocaine .


The increases in PI were associated with slightly higher SpHb values .


We conclude that the DNB induces increases in PI and temperature of the finger .


Because of the close relationship between finger temperature , PI , and SpHb , consistently increasing finger temperature and PI could increase the accuracy of SpHb .


The effectiveness of noninvasive positive-pressure ventilation in preventing reintubation due to respiratory failure in children remains uncertain .


A pilot study was designed to evaluate the frequency of extubation failure , develop a randomization approach , and analyze the feasibility of a powered randomized trial to compare noninvasive positive-pressure ventilation and standard oxygen therapy post extubation for preventing reintubation within 48 hours in children with respiratory failure .


Prospective pilot study .


PICU at a university-affiliated hospital .


Children aged between 28 days and 3 years undergoing invasive mechanical ventilation for greater than or equal to 48 hours with respiratory failure after programmed extubation .


Patients were prospectively enrolled and randomly assigned into noninvasive positive-pressure ventilation group and inhaled oxygen group after programmed extubation from May 2012 to May 2013 .


Length of stay in PICU and hospital , oxygenation index , blood gas before and after tracheal extubation , failure and reason for tracheal extubation , complications , mechanical ventilation variables before tracheal extubation , arterial blood gas , and respiratory and heart rates before and 1 hour after tracheal extubation were analyzed .


One hundred eight patients were included ( noninvasive positive-pressure ventilation group , n = 55 and inhaled oxygen group , n = 53 ) , with 66 exclusions .


Groups did not significantly differ for gender , age , disease severity , Pediatric Risk of Mortality at admission , tracheal intubation , and mechanical ventilation indications .


There was no statistically significant difference in reintubation rate ( noninvasive positive-pressure ventilation group , 9.1 % ; inhaled oxygen group , 11.3 % ; p > 0.05 ) and length of stay ( days ) in PICU ( noninvasive positive-pressure ventilation group , 3 [ 1-16 ] ; inhaled oxygen group , 2 [ 1-25 ] ; p > 0.05 ) or hospital ( noninvasive positive-pressure ventilation group , 19 [ 7-141 ] ; inhaled oxygen group , 17 [ 8-80 ] ) .


The study indicates that a larger randomized trial comparing noninvasive positive-pressure ventilation and standard oxygen therapy in children with respiratory failure is feasible , providing a basis for a future trial in this setting .


No differences were seen between groups .


The number of excluded patients was high .


The rate of prophylactic mastectomies ( PM ) is increasing .


Patients generally report high levels of health related quality of life and satisfaction after the procedure , whereas body image perception and sexuality may be negatively affected .


The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM .


Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible .


The following patient-reported outcome measures were used at study baseline and 2 years postoperatively : the body image scale ( BIS ) , the sexual activity questionnaire ( SAQ ) , the short-form health survey ( SF-36 ) , the hospital anxiety and depression scale ( HAD ) , and a study specific `` pain/motion/sensation scale '' .


Out of 125 patients invited to participate in this prospective randomized study , 43 ( 34 % ) consented and were randomized into the intervention ( n = 24 , 56 % ) or control ( n = 19 , 44 % ) groups .


There were no statistically significant between-group differences found with respect to BIS , SAQ , SF-36 , HAD , and `` pain/motion/sensation '' .


Two years postoperatively , more than half of the patients in both groups reported problems like feeling less attractive , less sexually attractive , their body feeling less whole , and being dissatisfied with their body .


A majority marked a decreased sensation in breast area .


The interest in a physiotherapy intervention was limited among women who had undergone PM .


The intervention did not show any substantial effects .


A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively .


Understanding and enhancing change capabilities , including Practice Adaptive Reserve ( PAR ) , of Community Health Centers ( CHCs ) may mitigate cancer-related health disparities .


Using stratified random sampling , we recruited 232 staff from seven CHCs serving Asian Pacific Islander communities to complete a self-administered survey .


We performed multilevel regression analyses to examine PAR composite scores by CHC , position type , and number of years worked at their clinic .


The mean PAR score was 0.7 ( s.d. 0.14 ) .


Higher scores were associated with a greater perceived likelihood that clinic staff would participate in an evidence-based intervention ( EBI ) .


Constructs such as communication , clinic flow , sensemaking , change valence , and resource availability were positively associated with EBI implementation or trended toward significance .


PAR scores are positively associated with perceived likelihood of clinic staff participation in cancer screening EBI .


Future research is needed to determine PAR levels most conducive to implementing change and to developing interventions that enhance Adaptive Reserve .


Although several plaque indices exist , they rarely assess in detail the plaque adjacent to the gingival margin , an area most important for periodontal health .


This study aims to develop a new marginal plaque index ( MPI ) and to assess its validity and treatment sensitivity compared to the internationally accepted Turesky modification of the Quigley and Hein Index ( TQHI ) .


Data from two studies with n = 64 and n = 67 participants , respectively , are reported here .


Convergence of MPI with TQHI and concurrent and predictive validity with papillary bleeding index were assessed , as was treatment sensitivity to a treatment of proximal hygiene ( study 1 ) or toothbrushing ( study 2 ) , respectively .


Convergent validity with TQHI is very good .


Concurrent and predictive validity parameters of the MPI are similar to the TQHI .


The treatment sensitivity of MPI exceeds TQHI by far .


This results in a reduction by > 70 % of the sample size needed to discover significant treatment effects .


As expected , the largest treatment sensitivity was observed for proximal MPI measures in study 1 , whereas study 2 showed largest effects for cervical measures .


MPI appears to be a valid plaque-scoring system that assesses plaque at the gingival margin .


It responds with high sensitivity to treatments aimed at plaque reduction at the gingival margin .


Its treatment sensitivity and capacity to differentiate between proximal and cervical plaque make it a promising tool for periodontal research .


We compared the effects of two uniquely different lower extremity power training interventions on changes in muscle power , physical performance , neuromuscular activation , and muscle cross sectional area in mobility-limited older adults .


Fifty-two subjects ( 785 years , short physical performance battery score : 8.11 ) were randomized to either 16 weeks of progressive high velocity resistance training performed at low external resistance ( 40 % of the 1-repetition maximum [ 1-RM ] [ LO ] ) or high external resistance ( 70 % of 1RM [ HI ] ) .


Both groups completed three sets of leg and knee extension exercises at maximum voluntary velocity , two times per week .


Neuromuscular activation was assessed using surface electromyography and muscle cross sectional area ( CSA ) was measured using computed tomography .


At 16 weeks , LO and HI exhibited significant and similar within-group increases of leg extensor peak power ( ~ 34 % vs ~ 42 % ) , strength ( ~ 13 % vs ~ 19 % ) , and SPPB score ( 1.40.3 vs 1.80.3 units ) , respectively ( all P < .03 ) .


Improvements in neuromuscular activation occurred in LO ( P = .03 ) while small gains in mid-thigh muscle CSA were detected in LO ( 1.6 % , P = .35 ) and HI ( 2.1 % , P = .17 ) .


No significant between-group differences were evident for any measured parameters ( all P > .25 ) .


High velocity resistance training with low external resistance yields similar improvements in muscle power and physical performance compared to training with high external resistance in mobility-limited elders .


These findings may have important implications for optimizing exercise interventions for older adults with mobility limitations .


Low levels of cardiorespiratory fitness are associated with high risk of non-communicable diseases and all-cause mortality .


Physical activity level is the primary determinant of cardiorespiratory fitness in adults .


However , knowledge on how to motivate people to engage in physical activity and maintain an active lifestyle is lacking .


This study aims to investigate whether a motivational , individual , and locally anchored exercise intervention , in primary care , can improve cardiorespiratory fitness in 30 to 49 year olds with a low or very low cardiorespiratory fitness .


Two-armed randomised controlled trial with 6 and 12 months follow-up .


The primary outcome is cardiorespiratory fitness estimated via a maximal incremental exercise test .


Secondary outcomes include physical activity level and sedentary behavior ( objectively measured ) , self-reported physical activity , biochemical parameters ( HbA1C , HDL - and LDL-cholesterol , and triglyceride ) , anthropometric parameters and health-related quality of life .


A total of 236 participants with low levels of cardiorespiratory fitness classified at a local health check programme will be randomised .


The intervention consists of four motivational interviews , a six months membership to a sport club , and a global positioning watch to upload training activity to Endomondo.com .


The comparison group will receive standard care : a one hour motivational interview followed by another interview if requested .


Effects will be estimated by evaluating the differences in mean changes in cardiorespiratory fitness between the two groups .


In new and innovative ways the focus of this study will be to improve cardiorespiratory fitness among a 30-49 year-old at-risk group using social media , Global Positioning System-technology , on-going personal support and individually tailored physical activity .


ClinicalTrials.gov ( no.NCT01801956 ) .


Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome ( ACS ) is poor .


To test a multifaceted intervention to improve adherence to cardiac medications .


In this randomized clinical trial , 253 patients from 4 Department of Veterans Affairs medical centers located in Denver ( Colorado ) , Seattle ( Washington ) ; Durham ( North Carolina ) , and Little Rock ( Arkansas ) admitted with ACS were randomized to the multifaceted intervention ( INT ) or usual care ( UC ) prior to discharge .


The INT lasted for 1 year following discharge and comprised ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and a patient 's primary care clinician and/or cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) .


The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered ( PDC ) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications ( clopidogrel , - blockers , 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [ statins ] , and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ ACEI/ARB ] ) .


Secondary outcomes included achievement of blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) level targets .


RESULTS Of 253 patients , 241 ( 95.3 % ) completed the study ( 122 in INT and 119 in UC ) .


In the INT group , 89.3 % of patients were adherent compared with 73.9 % in the UC group ( P = .003 ) .


Mean PDC was higher in the INT group ( 0.94 vs 0.87 ; P < .001 ) .


A greater proportion of intervention patients were adherent to clopidogrel ( 86.8 % vs 70.7 % ; P = .03 ) , statins ( 93.2 % vs 71.3 % ; P < .001 ) , and ACEI/ARB ( 93.1 % vs 81.7 % ; P = .03 ) but not - blockers ( 88.1 % vs 84.8 % ; P = .59 ) .


There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals .


A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring , patient education , collaborative care between pharmacist and patients ' primary care clinician and/or cardiologist , and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels .


Understanding the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program .


clinicaltrials.gov Identifier : NCT00903032 .


The Quality of Life-Bronchiectasis ( QOL-B ) , a self-administered , patient-reported outcome measure assessing symptoms , functioning and health-related quality of life for patients with non-cystic fibrosis ( CF ) bronchiectasis , contains 37 items on 8 scales ( Respiratory Symptoms , Physical , Role , Emotional and Social Functioning , Vitality , Health Perceptions and Treatment Burden ) .


Psychometric analyses of QOL-B V. 3.0 used data from two double-blind , multicentre , randomised , placebo-controlled , phase III trials of aztreonam for inhalation solution ( AZLI ) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection .


Excellent internal consistency ( Cronbach 's 0.70 ) and 2-week test-retest reliability ( intraclass correlation coefficients 0.72 ) were demonstrated for each scale .


Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores .


No floor or ceiling effects ( baseline scores of 0 or 100 ) were found for the Respiratory Symptoms scale ( primary endpoint of trials ) .


Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV % predicted in only one trial .


The minimal important difference score for the Respiratory Symptoms scale was 8.0 points .


AZLI did not show efficacy in the two phase III trials .


QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported .


Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations , indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores .


Previously established content validity , reliability and responsivity of the QOL-B are confirmed by this final validation study .


The QOL-B is available for use in clinical trials and routine clinical practice .


To estimate the short-term effectiveness , feasibility and acceptability of a smoking cessation intervention ( the iQuit system ) that consists of tailored printed and Short Message Service ( SMS ) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial .


A stratified two parallel-group randomized controlled trial comparing usual care ( control ) with usual care plus the iQuit system ( intervention ) , delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence .


Thirty-two general practice ( GP ) surgeries in England , UK .


A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized ( control n = 303 , intervention n = 299 ) .


Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up .


Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date , 8 weeks and 6 months follow-up .


There were no significant between-group differences in the primary outcome [ control 40.3 % , iQuit 45.2 % ; odds ratio ( OR ) = 1.22 , 95 % confidence interval ( CI ) = 0.88-1 .69 ] or in secondary short-term smoking outcomes .


Six-month prolonged abstinence was significantly higher in the iQuit arm ( control 8.9 % , iQuit 15.1 % ; OR = 1.81 , 95 % CI = 1.09-3 .01 ) .


iQuit support took on average 7.7 minutes ( standard deviation = 4.0 ) to deliver and 18.9 % ( 95 % CI = 14.8-23 .7 % ) of intervention participants discontinued the text message support during the programme .


Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence , but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone .


Compare HIV injecting and sex risk in patients being treated with methadone ( MET ) or buprenorphine-naloxone ( BUP ) .


Secondary analysis from a study of liver enzyme changes in patients randomized to MET or BUP who completed 24 weeks of treatment and had 4 or more blood draws .


The initial 1:1 randomization was changed to 2:1 ( BUP : MET ) after 18 months due to higher dropout in BUP .


The Risk Behavior Survey measured HIV risk before 30 days at baseline and weeks 12 and 24 .


Among 529 patients randomized to MET , 391 ( 74 % ) were completers ; among 740 randomized to BUP , 340 ( 46 % ) were completers ; 700 completed the Risk Behavior Survey .


There were significant reductions in injecting risk ( P < 0.0008 ) with no differences between groups in mean number of times reported injecting heroin , speedball , other opiates , and number of injections ; or percent who shared needles ; did not clean shared needles with bleach ; shared cookers ; or engaged in front/back loading of syringes .


The percent having multiple sex partners decreased equally in both groups ( P < 0.03 ) .


For males on BUP , the sex risk composite increased ; for males on MET , the sex risk decreased resulting in significant group differences over time ( P < 0.03 ) .


For females , there was a significant reduction in sex risk ( P < 0.02 ) with no group differences .


Among MET and BUP patients who remained in treatment , HIV injecting risk was equally and markedly reduced ; however , MET retained more patients .


Sex risk was equally and significantly reduced among females in both treatment conditions , but it increased for males on BUP and decreased for males on MET .


To explore the association of a functional germline variant in the 3 ' - UTR of KRAS with endometrial cancer risk , as well as the association of microRNA ( miRNA ) signatures and the KRAS-variant with clinical characteristics and survival outcomes in two prospective RTOG endometrial cancer trials .


The association of the KRAS-variant with endometrial cancer risk was evaluated by case-control analysis of 467 women with type 1 or 2 endometrial cancer and 582 age-matched controls .


miRNA and DNA were isolated for expression profiling and genotyping from tumor specimens of 46 women with type 1 endometrial cancer enrolled in RTOG trials 9708 and 9905 .


miRNA expression levels and KRAS-variant genotype were correlated with patient and tumor characteristics , and survival outcomes were evaluated by variant allele type .


The KRAS-variant was not significantly associated with overall endometrial cancer risk ( 14 % controls and 17 % type 1 cancers ) , although was enriched in type 2 endometrial cancers ( 24 % , p = 0.2 ) .


In the combined analysis of RTOG 9708/9905 , miRNA expression differed by age , presence of lymphovascular invasion and KRAS-variant status .


Overall survival rates at 3 years for patients with the variant and wild-type alleles were 100 % and 77 % ( HR 0.3 , p = 0.24 ) , respectively , favoring the variant .


The KRAS-variant may be a genetic marker of risk for type 2 endometrial cancers .


In addition , tumor miRNA expression appears to be associated with patient age , lymphovascular invasion and the KRAS-variant , supporting the hypothesis that altered tumor biology can be measured by miRNA expression , and that the KRAS-variant likely impacts endometrial tumor biology .


Thrombocytopenia in patients with myelodysplastic syndrome ( MDS ) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia ( AML ) .


In this study , the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate -1 - risk MDS .


Patients who had thrombocytopenia with low-risk/intermediate -1 - risk MDS ( N = 250 ) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks .


The primary endpoint - the number of clinically significant bleeding events ( CSBEs ) per patient-had a hazard ratio for romiplostim : placebo of 0.83 ( 95 % confidence interval , 0.66-1 .05 ; P = .13 ) .


CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts 2010 ( 9 ) / L ( P < .0001 ) .


For patients who had baseline platelet counts < 2010 ( 9 ) / L , there was no difference in the number of CSBEs , but the platelet transfusion rates were higher in the placebo group ( P < .0001 ) , which may have affected the overall CSBE results in this group with severe thrombocytopenia .


The incidence of bleeding events was reduced significantly in the romiplostim group ( relative risk , 0.92 ) , as were protocol-defined platelet transfusions ( relative risk , 0.77 ) .


Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim ( odds ratio , 15.6 ) .


On the basis of interim data , an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim ( interim hazard ratio , 2.51 ) .


At 58 weeks , the AML rates were 6 % in the romiplostim group and 4.9 % in the placebo group ( hazard ratio , 1.20 ; 95 % confidence interval , 0.38-3 .84 ) , and the overall survival rates were similar .


Romiplostim treatment in patients with low-risk/intermediate -1 - risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions .


Although study drug was discontinued because of an initial concern of AML risk , survival and AML rates were similar with romiplostim and placebo .


Transcranial direct current stimulation ( tDCS ) has demonstrated efficacy for reducing neuropathic pain , but the respective mechanisms remain largely unknown .


The current study tested the hypothesis that pain reduction with tDCS is associated with an increase in the peak frequency spectrum density in the theta-alpha range .


Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tDCS ( 2 mA ) over the left primary motor area ( M1 ) for 20 min .


Treatment order was randomly assigned .


Pre - to post-procedure changes in pain intensity and peak frequency of electroencephalogram spectral analysis were compared between treatment conditions .


The active treatment condition ( anodal tDCS over M1 ) but not sham treatment resulted in significant decreases in pain intensity .


In addition , consistent with the study hypothesis , peak theta-alpha frequency ( PTAF ) assessed from an electrode placed over the site of stimulation increased more from pre - to post-session among participants in the active tDCS condition , relative to those in the sham tDCS condition .


Moreover , we found a significant association between a decrease in pain intensity and an increase in PTAF at the stimulation site .


The findings are consistent with the possibility that anodal tDCS over the left M1 may be effective , at least in part , because it results in an increase in M1 cortical excitability , perhaps due to a pain inhibitory effect of motor cortex stimulation that may influence the descending pain modulation system .


Future research is needed to determine if there is a causal association between increased left anterior activity and pain reduction .


The results provide new findings regarding the effects of tDCS on neuropathic pain and brain oscillation changes .


Cerebral palsy ( CP ) is the most common motor disability in childhood ( 2 to 3 per 1000 live births ) , and is frequently accompanied by cognitive impairments and behavioural problems .


Children with CP are at increased risk of attention deficit disorder with or without hyperactivity ( Attention Deficit Disorder ( ADD ) / Attention Deficit Hyperactivity Disorder ( ADHD ) ) including working memory deficits .


The primary aim of this study is to evaluate if cognitive training may improve working memory in children with CP .


The study is an investigator-blinded , randomized controlled trial with a stepped-wedge design that will include 115 schoolchildren with CP .


Eligible for participation are children with CP , aged 7 to 15years , who are able to follow instructions and handle a computer mouse .


Exclusion criteria are the presence of photosensitive epilepsy , Gross Motor Function Classification System ( GMFCS ) level V ( most severe CP ) ( Phys Ther 80 : 974-985 , 2000 ) and severe visual or hearing impairments .


Following assessment of eligibility and baseline cognitive assessment the participants will be randomized to either cognitive working memory training or treatment-as-usual ( ` control group ' ) .


The intervention is a computer-based working memory training program consisting of 25 daily sessions to be performed over a 5 to 6-week period at home .


A neuropsychological assessment will be performed before and 4 to 6weeks after completed training .


When the latter assessment has been completed in the intervention group , the ` control group ' will start on the same training program .


Both groups will meet for a final neuropsychological assessment six months after completed training by an examiner unaware of group adherence .


There is limited evidence for the effect of most interventions in children with CP , and evidence is completely lacking for interventions aiming to improve deficits in cognition , learning and behaviour .


The proposed multicenter study , will bring forth comprehensive information about cognitive , neuropsychological , and daily-life functioning in children with CP aged between 7 and 15years .


In addition , the study will be the first to evaluate the effects of an intervention method to improve working memory in children with CP .


If successful , computer-based working memory training may represent an efficient and cost-effective intervention for this group of children .


ClinicalTrials.gov Identifier : NCT02119364 .


The prognostic significance of response to induction therapy for rhabdomyosarcoma ( RMS ) by anatomic imaging [ computerised tomographic ( CT ) or magnetic resonance imaging ( MRI ) scan ] is controversial .


We previously reported no relationship between early response and failure-free survival ( FFS ) on Intergroup Rhabdomyosarcoma Study ( IRS ) - IV .


We repeated the same analysis using a more recent clinical trial as an independent cohort of patients with non-metastatic , initially unresected RMS .


A total of 338 patients enrolled in Children 's Oncology Group ( COG ) study D9803 met the inclusion criteria for this analysis : ( 1 ) non-metastatic , initially unresected ( Group III ) ; ( 2 ) embryonal ( ERMS ) or alveolar ( ARMS ) histology ; ( 3 ) documented protocol week 12 response to induction chemotherapy ( excluding progressive disease ) based on anatomic imaging ( CT/MRI ) and ( 4 ) documented protocol therapy beyond week 12 .


Response at week 12 was determined by the treating institution as complete response ( CR ) , partial response ( PR ) or no response ( NR ) .


FFS was estimated using the Kaplan-Meier method and comparisons between patient subsets were made using the log-rank test .


Overall objective response rate ( CR+PR ) at week 12 of therapy was 85 % and was similar between ERMS and ARMS .


FFS was similar among all patients with CR , PR or NR ( p = 0.49 ) .


Restricting the analysis to either ERMS or ARMS , there was no difference in FFS by response within either histology subset ( p = 0.89 and p = 0.08 , respectively ) .


These findings provide additional evidence that anatomic imaging to assess early response to therapy among patients with RMS does not predict outcome and has questionable use in tailoring subsequent therapy .


Multicenter randomized controlled trial .


To evaluate the effect of recombinant human bone morphogenetic protein ( rhBMP-2 ) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft .


In many types of spinal surgery , radiographical fusion is a primary outcome equally important to clinical improvement , ensuring long-term stability and axial support .


Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective .


We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion .


Patients undergoing 1 - or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct .


Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively .


One hundred ninety seven patients were successfully randomized among the 8 participating institutions .


Adverse events attributable to the study drug were not significantly different compared with controls .


However , the control group experienced significantly more graft-site complications as might be expected .


36-Item Short Form Health Survey , Oswestry Disability Index , and leg/back pain scores were comparable between the 2 groups .


After 4 years of follow-up , radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 ( 94 % ) than those who received autograft ( 69 % ) ( P = 0.007 ) .


The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft .


However , there is no associated improvement in clinical outcome within a 4-year follow-up period .


These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern .


Informed and engaged parents and healthful home environments are essential for the health of youth .


Although research has shown health benefits associated with family meals , to date , no randomized controlled trial ( RCT ) has been developed to examine the impact of a family meals intervention on behavioral and health outcomes .


The Healthy Home Offerings via the Mealtime Environment ( HOME ) Plus study is a two-arm ( intervention versus attention-only control ) RCT being conducted in Minneapolis/St .


Paul .


Built on previous pilot research , HOME Plus aims to increase the frequency and healthfulness of family meals and snacks and reduce children 's sedentary behavior , particularly screen time , to promote healthier eating and activity behaviors and prevent obesity .


HOME Plus is delivered to families in community settings .


The program includes 10 monthly sessions focused on nutrition and activity education , meal planning and preparation skill development .


In addition , five motivational goal-setting phone calls are conducted with parents .


The primary outcome measure is age - and gender-adjusted child BMI-z score at post-intervention by treatment group .


Secondary household-level outcomes include family meal frequency , home availability of healthful foods ( fruits/vegetables ) and unhealthful foods ( high-fat/sugary snacks ) and beverages ( sugar-sweetened beverages ) , and the quality of foods served at meals and snacks .


Secondary child outcomes include dietary intake of corresponding foods and beverages and screen time .


The HOME Plus RCT actively engages whole families of 8-12 year old children to promote healthier eating and activity behaviors and prevent obesity through promotion of family meals and snacks and limited media use .