Cognitive domains were defined according to the Measurement and Treatment Research to Improve Cognition in Schizophrenia ( MATRICS ) consensus battery and averaged in a global cognitive composite score .


After CRT , significant improvements were found in verbal memory and executive functions , with medium-to-large effect sizes ( ES ) .


The derived cognitive composite score showed an improvement after the treatment , with a large ES .


This change was reliable in more than two-thirds of the treated patients .


Medium-sized ES were found for improvements after CRT in daily living and adaptive functioning , whereas large ES were observed for improvements in family burden .


With the exception of functional gains , these changes were maintained after @ months .


CRT appears to be a useful intervention strategy for adolescents with EOS .


Cognitive improvements can be achieved through CRT , although further research is warranted to determine the durability of functional gains .


Clinical trial registration information-Cognitive Remediation Therapy ( CRT ) in Adolescents With EOS ; www.clinicaltrials.gov ; NCT@ .


Sentinel lymph node biopsy ( SLNB ) has become the gold standard for axillary staging .


Debate remains as to the optimal method of SLN detection .


Determine whether patients undergoing an SLNB required the addition of isosulfan blue dye to radioisotope when an SLN was identified on a preoperative lymphoscintigram .


A prospective randomized controlled trial comparing the combination of radioisotope and blue dye versus radioisotope alone was performed between March @ and September @ .


The trial protocol was registered with Current Controlled Trials .


Women with clinically and radiologically node-negative breast cancer with a positive preoperative lymphoscintigram were eligible for inclusion .


A total of @ patients were included in the analysis with @ patients receiving the combination ( blue dye and radioisotope ) and @ patients receiving radioisotope alone .


The groups were evenly matched both demographically and pathologically .


The mean age was @ years ( @ vs @ years ; P = @ ) , the mean tumour size was @ mm ( @ mm vs @ mm ; P = @ ) and there was no statistically significant difference in the grade of the tumors between the @ groups ( P = @ ) .


There was no difference in the identification rate , nor was that in the number of nodes retrieved between the @ groups ( P = @ ) .


There was no difference in the number of positive lymph nodes that were identified between the @ groups ( @ % vs @ % ; P = @ ) .


This study failed to demonstrate an advantage with the addition of isosulfan blue dye to radioisotope in the identification of the SLN in the presence of a positive preoperative lymphoscintigram .


Substance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes .


Up to @ % of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems .


However , this is not routinely addressed as part of their treatment plan .


A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use .


This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention .


This randomized controlled trial will use concealed randomization ; blind , independent assessment of outcome at @ months ; characterization of refusers and dropouts ; and be analyzed according to the intention-to-treat principle .


After baseline assessments , eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual , or Treatment as Usual alone .


Eligible participants will be those who are new admissions ; > @ years ; ICD-@ diagnosis of - schizophrenia or related disorder , bipolar affective disorder , recurrent depressive disorder , and DSM-IV diagnosis of substance abuse or dependence over the last @ months .


The primary outcome is engagement in treatment for substance misuse , and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis .


Qualitative interviews with staff and participants will assess the acceptability of the intervention .


This pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible , cost-effective , and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care .


To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol , The Evaluation of Choline Fenofibrate ( ABT-@ ) on Carotid Intima-Media Thickness ( cIMT ) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy ( FIRST ) trial evaluated the effects of fenofibric acid ( FA ) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin .


This multicenter , double-blind , placebo-controlled study was performed in patients with mixed dyslipidemia ( fasting triglycerides , @ mg/dL ; high-density lipoprotein cholesterol , @ -LSB- men -RSB- or @ mg/dL -LSB- women -RSB- ; low-density lipoprotein cholesterol , @ mg/dL once and averaging @ mg/dL ) and a history of coronary heart disease or risk equivalent .


Patients on background atorvastatin ( continued on starting dose or titrated to @ mg , if needed ) were randomized to FA @ mg or placebo .


The primary end point was rate of change from baseline through week @ of the mean posterior-wall cIMT , measured by ultrasound .


In patients with controlled low-density lipoprotein cholesterol while on atorvastatin background therapy , rate of change in posterior-wall cIMT was similar with FA plus atorvastatin ( -@ mm/y ) versus atorvastatin monotherapy ( @ mm/y ; P = @ ) .


FA plus atorvastatin was favored ( P < @ ) in @ of @ prespecified subgroups : age @ years , history of coronary artery disease , cIMT > @ mm , triglycerides @ to @ mg/dL , and statin use at entry .


Adverse events were consistent with the known safety profiles of both drugs ; however , FA plus atorvastatin was associated with a greater incidence of renal-related adverse events compared with atorvastatin monotherapy ( @ % versus @ % ) .


Compared with atorvastatin monotherapy , FA plus atorvastatin did not further decrease cIMT progression in high-risk patients with mixed dyslipidemia .


The role of glycemic index ( GI ) and foods with negative attributes related to GI as part of a weight loss regimen has not been thoroughly assessed in free-living individuals .


This study examined the effects of a dietary prescription for energy intake modification , GI , and potato consumption on weight loss , dietary prescription adherence , body composition , and glucose control in a free-living , self-selecting overweight population .


Ninety overweight ( body mass index -LSB- BMI -RSB- @ @ ) men and women were randomly assigned to one of @ groups for @ weeks .


Two groups were counseled to reduce their energy intake by @ kcal/day and consume diets that were predominantly composed of either low - or high-GI foods ( low glycemic index energy reduced -LSB- LGI-ER -RSB- or high glycemic index energy reduced -LSB- HGI-ER -RSB- diet , respectively ) .


The third group received no energy restriction , GI provision , or nutritional counseling .


All groups were instructed to consume @-@ servings of potatoes per week .


Changes in weight , body composition , glucose tolerance , and triglycerides were determined at baseline and @ weeks .


There were no significant differences in weight loss or changes in body composition between the groups ; however , modest weight loss and body composition changes were seen from week @ to week @ for all groups ( p < @ ) .


Difficulty achieving the prescribed GI diets was evident in this free-living setting .


There were no significant changes within or among treatments for fasting concentrations of triglycerides , glucose tolerance , insulin , or insulin sensitivity .


The results indicate that in a free-living population of men and women , weight loss is associated with energy intake reduction .


Potato intake did not cause weight gain and following either a high - or low-GI dietary prescription was difficult for free-living subjects , emphasizing the complex nature of changing dietary patterns .


This prospective , randomized , single-blinded study evaluates the effectiveness of the ultrasound-guided bilateral thoracic paravertebral ( BTPV ) block for providing postoperative pain control in children undergoing the Nuss procedure .


Thirty American Society of Anesthesiologists I-II children with pectus excavatum , scheduled for the Nuss procedure , were enrolled at West China Hospital of Sichuan University .


The patients were randomly allocated into the BTPV block group or the control group .


In the BTPV group , @ % ropivacaine @ mL/kg with @:@,@ epinephrine was injected under ultrasound guidance on each side at the level of the fifth thoracic vertebra .


Postoperative pain was evaluated in both groups for the first @ hours .


Total opioid administered and cumulative attempts on the patient/parent-controlled intravenous analgesia ( PCA ) pump were recorded .


Postoperative negative behavioral changes in the children were evaluated on postoperative days @ , @ , and @ , respectively , using the posthospital behavior questionnaire .


The pain scores were significantly reduced in the postanesthesia care unit and for the first @ hours postoperatively in the BTPV group compared to the control group ( P < @ ) .


The sufentanil use in the postanesthesia care unit was significantly greater in the control group -LSB- mean ( SD ) , @ ( @ ) mcg/kg -RSB- compared to the BTPV group -LSB- mean ( SD ) , @ ( @ ) mcg/kg -RSB- ( P < @ ) .


The postoperative sufentanil use was significantly higher in the control group during the first @ hours ( P < @ ) .


Numbers of attempts on the PCA pump were significantly greater in the control group ( P < @ ) .


The posthospital behavior questionnaire score was lower in the BTPV group on day @ , day @ , and @ month , respectively ( P < @ ) .


Ultrasound-guided BTPV block provides improved postoperative analgesia for children undergoing the Nuss procedure as compared with intravenous PCA and decreases the incidence of postoperative behavioral disturbance .


Tumour shrinkage ( TS ) increases the possibility of resection in metastatic colorectal cancer ( mCRC ) and may improve tumour-related symptoms .


Here we report prespecified secondary response-related end-points and exploratory TS/resection outcomes for patients with RAS wild-type ( WT ) tumours ( no mutations in KRAS/NRAS exons @/@/@ ) from the PRIME study ( NCT@ ) .


PRIME was a randomised phase @ study comparing first-line panitumumab + FOLFOX@ versus FOLFOX@ in mCRC patients .


Tumour response analyses were conducted to compare response rates and their impact on survival outcomes .


Overall , @ patients had RAS WT mCRC .


More patients receiving panitumumab + FOLFOX@ versus FOLFOX@ had @ % ( @ % versus @ % ; P < @ ) or @ % ( @ % versus @ % ; P < @ ) TS at week @ ( early TS ) ; consistent TS benefits were observed over the first @weeks of treatment .


Objective response rate ( P = @ ) , duration of response ( P = @ ) , depth of response ( P = @ ) , progression-free survival ( PFS ; P = @ ) and overall survival ( OS ; P = @ ) were improved in the panitumumab + FOLFOX@ group .


Both early TS and resection were associated with improved PFS and OS .


@-year OS rates for patients who did ( n = @ ) versus did not ( n = @ ) undergo resection were @ % versus @ % ; @-year OS rates for patients who did ( n = @ ) versus did not ( n = @ ) undergo complete resection were @ % versus @ % .


More patients receiving panitumumab + FOLFOX@ versus FOLFOX@ had @ % or @ % TS at week @ ; PFS and OS were also improved with panitumumab + FOLFOX@ .


The clinical value of achieving early TS in mCRC warrants further investigation .


This was a randomized , placebo-controlled , double-blind , sequential , ascending-dose study to assess the safety , tolerability , pharmacokinetics , and pharmacodynamics of multiple oral doses of apixaban in healthy Japanese male subjects .


The study was conducted using three sequential dose panels : apixaban @ mg , @ mg , and @ mg given twice daily .


For each dose panel , subjects were randomly assigned to receive oral apixaban ( n = @ ) or matching placebo ( n = @ ) for @ days .


The pharmacokinetics of apixaban and effect on pharmacodynamic variables ( clotting assays and anti-Xa activity ) were assessed on day @ and day @ of treatment .


Safety was assessed throughout the study .


Only after the preceding dose was confirmed to be safe and well-tolerated subjects were enrolled into the next-higher-dose panel .


Apixaban was safe and well-tolerated in these healthy Japanese male subjects across the doses evaluated .


On day @ , peak plasma concentrations were reached ~ @ hours postdose , and increases in peak plasma concentration ( C ( max ) ) , trough plasma concentration , and area under the plasma concentration-time curve across one dosing interval ( @ hours ) were tested dose-proportional across the dose range .


A modest degree of accumulation was observed that was similar for all doses ( accumulation index of @ to @ ) , and renal clearance was consistent across doses ( @ L/h - @ L/h ) .


Exposure-dependent prolongation of prothrombin time , activated partial thromboplastin time , modified prothrombin time , and increases in anti-Xa activity were observed after single and multiple doses of apixaban .


Apixaban was safe and well-tolerated in healthy Japanese subjects .


The pharmacokinetic profile of apixaban following multiple twice-daily doses was linear , and exposure parameters such as C ( max ) , observed at ~ @ hours post-dose , and area under the plasma concentration-time curve increased in a dose-proportional manner .


Pharmacodynamic profiles closely followed the apixaban plasma concentration-time profiles .


An intervention was designed to introduce rapid diagnostics tests for malaria ( mRDTs ) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy ( ACT ) .


We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities ( patients ) and the public sector ( health facility staff and district officials ) to the behavioral changes in diagnosis , treatment and referral being introduced in drug shops .


The intervention was designed to be evaluated through a cluster randomized trial .


In this paper , we present detailed design , implementation and evaluation experiences in order to help inform future studies of a complex nature .


Three preparatory studies ( formative , baseline and willingness-to-pay ) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops , and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities .


The intervention required careful design with the intention to be acceptable , sustainable and effective .


Critical components of intervention were : community sensitization and creating awareness , training of drug shop vendors to diagnose malaria with mRDTs , treat and refer customers to formal health facilities , giving pre-referral rectal artesunate and improved record-keeping .


The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT , evaluated against microscopy on a research blood slide .


Introducing mRDTs in drug shops may seem simple , but our experience of intervention design , conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological , social science and health economics methodologies .


The trial was conducted in phases sequenced such that each benefited from the other .


The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa ; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour .


To identify risk factors for recurrent urinary tract infection ( UTI ) and renal scarring in children who have had @ or @ febrile or symptomatic UTIs and received no antimicrobial prophylaxis .


This @-year , multisite prospective cohort study included @ children aged @ to @ months with vesicoureteral reflux ( VUR ) receiving placebo in the RIVUR ( Randomized Intervention for Vesicoureteral Reflux ) study and @ children with no VUR observed in the CUTIE ( Careful Urinary Tract Infection Evaluation ) study .


Primary exposure was presence of VUR ; secondary exposures included bladder and bowel dysfunction ( BBD ) , age , and race .


Outcomes were recurrent febrile or symptomatic urinary tract infection ( F/SUTI ) and renal scarring .


Children with VUR had higher @-year rates of recurrent F/SUTI ( Kaplan-Meier estimate @ % compared with @ % for VUR and no VUR , respectively ) .


Other factors associated with recurrent F/SUTI included presence of BBD at baseline ( adjusted hazard ratio : @ -LSB- @ % confidence interval ( CI ) : @-@ @ -RSB- ) and presence of renal scarring on the baseline ( @m ) Tc-labeled dimercaptosuccinic acid scan ( adjusted hazard ratio : @ -LSB- @ % CI : @-@ @ -RSB- ) .


Children with BBD and any degree of VUR had the highest risk of recurrent F/SUTI ( @ % ) .


At the end of the @-year follow-up period , @ ( @ % ) children in the no VUR group and @ ( @ % ) in the VUR group had renal scars , but the difference was not statistically significant ( adjusted odds ratio : @ -LSB- @ % CI : @-@ @ -RSB- ) .


VUR and BBD are risk factors for recurrent UTI , especially when they appear in combination .


Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD .


Exercise intolerance is a hallmark of heart failure , but factors associated with impaired exercise capacity in heart failure with preserved ejection fraction are unclear .


We hypothesized that in heart failure with preserved ejection fraction , the severity of resting ventricular and vascular dysfunction are associated with impairment in exercise tolerance as assessed by peak oxygen consumption .


Subjects with heart failure with preserved ejection fraction enrolled in the PhosphodiesteRasE-@ Inhibition to Improve CLinical Status And EXercise Capacity in Diastolic Heart Failure ( RELAX ) clinical trial ( n = @ ) underwent baseline Doppler echocardiography , cardiopulmonary exercise testing , and cardiac MRI .


RELAX participants were elderly ( median age @ years ) and @ % were women .


Ejection fraction ( @ % ) and stroke volume ( @ mL ) were normal , while diastolic dysfunction ( medial E/e ' , @ ; deceleration time , @ ms ; left atrial volume , @ mL/m ( @ ) ) and increased arterial load ( arterial elastance , @ mm Hg/mL ) were evident .


Peak oxygen consumption was reduced ( @ mLkg ( -@ ) min ( -@ ) , @ mL/min ) and age , sex , body mass index , hemoglobin , and chronotropic response collectively explained @ % of the variance in raw peak oxygen consumption ( mL/min ) .


After adjustment for these variables , left ventricular structure ( diastolic dimension -LSB- @ % , P = @ -RSB- and left ventricular mass -LSB- @ % , P = @ -RSB- ) , resting stroke volume ( @ % , P = @ ) , left ventricular diastolic dysfunction ( deceleration time -LSB- @ % , P = @ -RSB- and E/e ' -LSB- @ % , P = @ -RSB- ) , and arterial function ( arterial elastance -LSB- @ % , P = @ -RSB- and systemic arterial compliance -LSB- @ % , P = @ -RSB- ) , each explained only a small additional portion of the variance in peak oxygen consumption .


In heart failure with preserved ejection fraction , potentially modifiable factors ( obesity , anemia , and chronotropic incompetence ) are strongly associated with exercise capacity , whereas resting measures of ventricular and vascular structure and function are not .


Epidermal growth factor receptor tyrosine kinase inhibitors ( EGFR-TKIs ) show great efficacy in patients with advanced non-small cell lung cancer ( NSCLC ) with EGFR mutations .


The efficacy and safety of gefitinib following adjuvant chemotherapy in patients with EGFR mutation are unknown .


In this open-label , phase II study , patients with resected stage IIIA-N@ NSCLC harbouring EGFR mutations ( either exon @ deletion or L@R point mutation ) were assigned randomly to receive pemetrexed ( @mg/m ( @ ) ) and carboplatin ( AUC = @ ) , administered every @days for @ cycles , followed with or without gefitinib ( @mg/day ) for @months .


The primary end point was disease-free survival ( DFS ) .


From August @ to September @ , @ patients were included in our center .


DFS was significantly longer among those who received pemetrexed and carboplatin ( PC ) - gefitinib than among those who received PC alone -LSB- hazard ratio ( HR ) , @ ; @ % confidence interval ( CI ) @-@ @ ; P = @ ; median , @ vs. @ months -RSB- .


The rates of @-year DFS were @ % in the PC-gefitinib group and @ % in the PC alone group .


The rates of @-year overall survival ( OS ) were @ % in the PC-gefitinib group and @ % in the PC alone group ( HR , @ ; @ % CI @-@ @ , P = @ ) .


The most common adverse event was rash ( @ % , @/@ ) in the PC-gefitinib group and the administration of gefitinib following chemotherapy was well tolerated .


The administration of gefitinib following PC adjuvant therapy shows significant improvement in DFS in patients with resected stage IIIA-N@ NSCLC harbouring EGFR mutations .


Inflammation is fundamental to the development of atherosclerosis .


We examined the effect of anti-inflammatory doses of salicylate on endothelium-dependent vasodilation , a biomarker of cardiovascular risk , in a broad range of subjects .


We performed a randomized , double-blind , placebo-controlled crossover trial evaluating the effects of @ weeks of high-dose salsalate ( disalicylate ) therapy on endothelium-dependent flow-mediated and endothelium-independent vasodilation .


Fifty-eight subjects , including @ with metabolic syndrome , @ with atherosclerosis , and @ healthy controls , were studied .


Among all subjects , endothelium-dependent flow-mediated vasodilation decreased after salsalate compared with placebo therapy ( P = @ ) , whereas nitroglycerin-mediated , endothelium-independent vasodilation was unchanged ( P = @ ) .


Endothelium-dependent flow-mediated vasodilation after salsalate therapy was impaired compared with placebo therapy in subjects with therapeutic salicylate levels ( n = @ , P < @ ) but not in subjects with subtherapeutic levels ( P > @ ) .


Salsalate therapy , particularly when therapeutic salicylate levels are achieved , impairs endothelium-dependent vasodilation in a broad range of subjects .


These data raise concern about the possible deleterious effects of anti-inflammatory doses of salsalate on cardiovascular risk .


Effective strategies to address risk factors of non-communicable diseases are required to curtail the expanding costs of health care .


This trial tested the effectiveness over one year of a minimal intervention targeting multiple health behaviours ( diet , physical activity , alcohol and smoking ) in a general practice setting , through the provision of personalised , computer-tailored feedback .


Patients who had attended a general practice in the previous @ months were recruited from @ general practitioners in Brisbane , Australia .


Baseline data were collected using self-reports on adherence to ten health behaviours and summarised into a health score from @ to @ .


This randomised controlled trial used a @ factorial design , with one arm randomising subjects to the intervention or control group .


The other arm was either feedback at baseline ( single contact ) or an additional assessment with feedback at @ months ( dual contact ) .


As such , @ study groups created were , to which participants were randomised blindly : A. Intervention with single contact ; B. Intervention with dual contact ; C. Control with single contact and D. Control with dual contact .


All participants were assessed again at @ months .


Of the @ participants randomised , @ completed questionnaires at @ months .


Both single and dual contact groups improved their @ item health scores ( +@ and +@ respectively ) relative to control group outcomes ( +@ ; p < @ ) .


Improvement in adherence to guidelines for fish intake , type of milk consumed , vegetable and fruit intake , and alcohol intake were observed in single and dual contact intervention groups ( p < @ ) .


Both intervention groups showed greater improvement than controls for individual health behaviours , apart from red meat intake , smoking behaviour , physical activity and body weight .


Interestingly , there was an improvement in reported non-smoking rates in both intervention and control groups ( @ % single contact ; @ % dual contact ) .


Small but meaningful long-term changes in health behaviours can be achieved with a low-intensity intervention , which may reduce health care costs if implemented on a large scale .


Further research is needed to better understand the mechanism by which maintenance of behaviour change can be achieved .


( @ ) - Tetrahydrocannabinol has been shown to modulate anxiety and facilitate the extinction of fear by inhibiting amygdala reactivity .


Since functional coupling between the amygdala and prefrontal cortex is implicated in affective processes , it is possible that ( @ ) - tetrahydrocannabinol affects amygdala-prefrontal cortex functional connectivity in ways that differ across amygdala subregions : basolateral , centromedial , and superficial .


The aim of the study was to examine the effects of ( @ ) - tetrahydrocannabinol on functional connectivity between amygdala subregions and the prefrontal cortex during socio-emotional threat in healthy adults using a double-blind , placebo-controlled , within-subjects design .


Sixteen subjects completed a functional magnetic resonance imaging task designed to probe amygdala responses to social threat .


Amygdala subregion-prefrontal cortex functional connectivity was compared between ( @ ) - tetrahydrocannabinol and placebo using generalized psychophysiological interaction analyses .


Findings indicated that ( @ ) - tetrahydrocannabinol enhanced basolateral and superficial amygdala connectivity to the rostral anterior cingulate/medial prefrontal cortex .


These effects , including ( @ ) - tetrahydrocannabinol 's potential ability to reduce threat perception or enhance socio-emotional regulation , may help understand the neurocircuitry of affect .


A key phenomenon in rheumatoid arthritis is the formation of lymphoid follicles in the inflamed synovial membrane .


C-X-C motif chemokine @ ( CXCL@ ) is central in this process as it attracts C-X-C chemokine receptor type @ ( CXCR@ ) - expressing B cells and T follicular helper cells to the follicle .


We here examine the role of CXCL@ and its association with disease in patients with treatment-nave early rheumatoid arthritis .


Plasma samples from patients in the OPERA trial were examined for CXCL@ at treatment initiation and after @ months of treatment with either methotrexate plus placebo ( DMARD ) ( n = @ ) or methotrexate plus adalimumab ( DMARD + ADA ) ( n = @ ) .


Treatment outcome was evaluated after @ and @ years .


CXCL@ plasma levels in healthy volunteers ( n = @ ) were also examined .


Baseline CXCL@ plasma levels were increased in early rheumatoid arthritis patients in comparison with healthy volunteers .


Also , plasma CXCL@ correlated positively with disease activity parameters ; swollen joint count @ ( rho = @ ) and @ ( rho = @ ) , visual analog score ( rho = @ ) and simplified disease activity index ( rho = @ ) ( all P < @ ) .


CXCL@ levels decreased a significantly twofold more in the DMARD + ADA group than in the DMARD group .


Baseline CXCL@ plasma levels in the DMARD group correlated inversely with disease activity parameters ; disease activity score in @ joints , four variables , C-reactive protein based ( DAS@CRP ) ( rho = @ , P < @ ) at @ months .


High baseline CXCL@ was associated with remission ( DAS@CRP less than @ ) after @ years .


In treatment-nave early rheumatoid arthritis patients , plasma CXCL@ levels were associated with joint inflammation .


Furthermore , patients with high baseline plasma CXCL@ levels had an improved chance of remission after @ years .


We propose that high CXCL@ concentrations indicate recent onset of inflammation that may respond better to early aggressive treatment .


Thus , high levels of CXCL@ could reflect the ` the window of opportunity ' for optimal treatment effect .


Strategies to implement post exposure prophylaxis ( PEP ) in case of an anthrax bioterror event are needed .


To increase the number of doses of vaccine available we evaluated reducing the amount of vaccine administered at each of the vaccinations , and reducing the number of doses administered .


Healthy male and non-pregnant female subjects between the ages of @ and @ were enrolled and randomized @:@:@:@ to one of four study arms to receive @ mL ( standard dose ) of vaccine subcutaneously ( SQ ) at : ( A ) days @ , @ ; ( B ) days @ and @ ; ( C ) days @ , @ , and @ ; or ( D ) @ mL at days @ , @ , and @ .


A booster was provided on day @ .


Safety was assessed after each dose .


Blood was obtained on days @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ and both Toxin Neutralizing antibody and anti-PA IgG antibody measured .


Almost all subjects developed some local reactions with @-@ % reported to be of moderate severity and @ % severe during the primary series .


Vaccine groups that included a day @ dose induced a @ fold antibody rise in more subjects on days @ , @ , and @ than the arm without a day @ dose .


However , schedules with a full day @ dose induced higher peak levels of antibody that persisted longer .


The half dose regimen did not induce antibody as well as the full dose study arms .


Depending on the extent of the outbreak , effectiveness of antibiotics and availability of vaccine , the full dose @ , @ or @ , @ , @ schedules may have advantages .


The development of specific screening programs for individuals with a family history of colorectal cancer ( CRC ) is a priority .


This study evaluates the diagnostic performance of serum soluble CD@ ( sCD@ ) in family-risk individuals and compares this marker with the faecal immunochemical test for the detection of advanced neoplasia ( AN ) ( CRC or advanced adenomas ; AA ) .


Five hundred and sixteen asymptomatic individuals with at least one first-degree relative with CRC were included .


Serum sCD@ was measured in all the individuals who also underwent a colonoscopy ( @ AA and four cancer cases were found ) and a faecal immunochemical test .


Setting specificity to @ % and @ % , respectively , sCD@ showed a sensitivity of @ % and @ % for AA , and of @ % and @ % for AN .


The combination of sCD@ and the faecal test detected AA and AN with a @ % and @ % sensitivity , corresponding to @ % specificity .


The combination of serum sCD@ and the faecal blood test could result a valuable strategy for detecting AN in familial-risk CRC screening .


Ramosetron is a new selective @-hydroxytryptamine type @ ( @-HT@ ) receptor antagonist that reportedly has more potent antiemetic effects than other @-HT@ receptor antagonists .


The aim of this study was to determine the effect of ramosetron pretreatment on gastric emptying using the @C-acetic acid breath test .


Ten healthy male and female volunteers participated in this randomized , twoway crossover study .


After they had fasted overnight , the subjects were randomly assigned to receive @ mg ramosetron @ hour before ingestion of a test meal ( @ kcal per @ mL , containing @ mg @C acetate ) or to receive the test meal alone .


Under both conditions , breath samples were collected for @ min following ingestion of the meal .


Statistical comparison of the parameters between the two test conditions was performed .


No significant differences in the calculated parameters , including T @/@ , T lag , GEC or and , were observed between the two test conditions .


The present study revealed that @ mg ramosetron had no significant effect on the rate of gastric emptying .


Thus , our results suggest that ramosetron can be administered safely , without gastrointestinal adverse effects , even to terminal cancer patients with delayed or accelerated gastric emptying abnormality .


Although children with acute lymphoblastic leukemia ( ALL ) mount immune responses after vaccination with the trivalent influenza vaccine ( TIV ) , these responses are lower compared to controls .


Recently , a high dose ( HD ) TIV was found to increase the level of antibody response in elderly patients compared to the standard dose ( SD ) TIV .


We hypothesized that the HD TIV would be well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects with ALL .


This was a randomized , double-blind , phase I safety trial comparing the HD to the SD TIV in children with ALL .


Our secondary objective was immunogenicity .


Subjects were randomized @:@ to receive either the HD ( @ g ) or the SD ( @ g ) TIV .


Local and systemic reactions were solicited , hemagglutinin inhibition titers to influenza virus antigens were measured , and monitoring labs were collected prior to and/or after each vaccination .


Fifty subjects were enrolled ( @ HD , @ SD ) .


Mean age was @ years ; @ % were male , and @ % were in maintenance therapy .


There were no significant differences reported in local or systemic symptoms .


No severe adverse events were attributed to vaccination .


No significant differences between the HD and SD TIV groups were noted for immune responses .


No differences were noted between the HD and SD TIV groups for solicited systemic and local reactions .


Since this study was not powered for immunogenicity , a phase II trial is needed to determine the immunogenicity of HD versus SD TIV in the pediatric ALL population .


The objective of this study was to evaluate the efficacy of subcutaneous ( SC ) sedation using midazolam with and without ketamine in non-cooperative pediatric patients undergoing dental treatment .


A prospective , randomized , controlled , double-blind , crossover pilot clinical trial was carried out in @ children , aged between @-@ months , ASA l , Frankl @ .


Two sedation schemes were administered SC : Midazolam alone ( M ) , and a combination of Midazolam-Ketamine ( MK ) .


Both regimens were administered to the same patient in two consecutive treatment sessions , in accordance with a random assignment .


Overall behavior , movement , and crying were assessed according to the modified Houpt scale .


Heart rate , blood pressure , blood oxygen saturation , and possible side effects were also monitored .


The percentage of non-crying children was always higher in the treatment with MK compared with the treatment with M , but without a significant statistical difference .


Regarding variable body movement , the percentage of children without movement was higher in the MK group , although only up to minute @ ; no significant differences were found at @ , @ , and @ minutes , and from minute @ , body movement was lower in the M group .


Midazolam alone and the midazolam-ketamine combination administered subcutaneously resulted in a safe and efficient pharmacological method for providing moderate sedation to non-cooperative pediatric patients undergoing dental treatment .


During atrial fibrillation ( AF ) , conventional electrophysiological techniques for assessment of refractory period or conduction velocity of the atrioventricular ( AV ) node can not be used .


We aimed at evaluating changes in AV nodal properties during administration of metoprolol from electrocardiogram data , and to support our findings with simulated data based on results from an electrophysiological study .


Sixty patients ( age @ @ years , @ men ) with permanent AF were included in the RATe control in Atrial Fibrillation ( RATAF ) study .


Two @ min segments , during baseline and metoprolol administration , starting at @ pm were analysed in this study .


Atrial fibrillatory rate ( AFR ) , heart rate ( HR ) , and AV nodal parameters were assessed .


The AV nodal parameters account for the probability of an impulse not taking the fast pathway , the absolute refractory periods of the slow and fast pathways ( aRPs and aRPf ) , representing the functional refractory period , and their respective prolongation in refractory period .


In addition , simulated RR series were generated that mimic metoprolol administration through prolonged AV conduction interval and AV node effective refractory period .


During metoprolol administration , AFR and HR were significantly decreased and aRP was significantly prolonged in both pathways ( aRPs : @ @ vs. @ @ ms , P < @ ; aRPf : @ @ vs. @ @ ms , P < @ ) .


Similar results were found for the simulated RR series , both aRPs and aRPf being prolonged with metoprolol ( aRPs : @ @ vs. @ @ ms , P = @ ; aRPf : @ @ vs. @ @ ms , P = @ ) .


The AV nodal parameters reflect expected changes after metoprolol administration , i.e. a prolongation in functional refractory period .


The simulations confirmed that aRPs and aRPf may serve as an estimate of the functional refractory period .


Early handling alters adult behavioral responses to palatable food and to its withdrawal following a period of chronic exposure .


However , the central mechanisms involved in this phenomenon are not known .


Since neonatal handling has persistent effects on stress and anxiety responses , we hypothesized that its involvement in the aforementioned association may be associated with differential neuroadaptations in the amygdala during withdrawal periods .


Litters were randomized into two groups : handled ( H , removed from their dam for @min per day from the first to the tenth postnatal day and placed in an incubator at @C ) and non-handled ( NH ) .


Experiment @ : on PNDs @-@ , females were assigned to receive palatable food + rat chow for @ or @ days , and these two groups were compared in terms of palatable food preference , body weight and abdominal fat deposition .


In Experiment @ , H and NH rats were exposed to a chronic diet of palatable food + rat chow for @ days , followed by ( a ) no withdrawal , ( b ) @h withdrawal from palatable food ( receiving only rat chow ) or ( c ) @-day withdrawal from palatable food ( receiving only rat chow ) .


Body weight , @-min rebound palatable food intake , abdominal fat deposition , serum corticosterone as well as TH and pCREB levels in the amygdala were then compared between groups .


Experiment @-chronic exposure to palatable food induces comparable metabolic effects after @ and @ days .


Experiment @-neonatal handling is associated with a peculiar response to palatable food withdrawal following chronic exposure for @ days .


Rats exposed to early handling ingested less of this food after a @h withdrawal period , and displayed increased amygdala TH and pCREB levels .


Variations in the neonatal environment affect both behavioral responses and amygdala neuroadaptation to acute withdrawal from a palatable diet .


These findings contribute to the comprehension of the mechanisms that link early life events and altered feeding behavior and related morbidities such as obesity in adulthood .


Hyperuricemia is a risk factor for the onset of chronic kidney disease ( CKD ) and is significantly associated with the progression of CKD .


However , there is no sufficient evidence by interventional research supporting a cause-effect relationship .


Hyperuricemic patients without gouty arthritis , whose serum urate ( SUA ) concentration is @ mg/dL and who have a complication , are treated by pharmacotherapy in addition to lifestyle guidance .


Nevertheless , there is no evidence that rationalizes pharmacotherapy for patients with hyperuricemia who have no complication and whose SUA concentration is below @ mg/dL .


The FEATHER ( FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage @ ) study is a prospective , multicenter , double-blind , randomized , placebo-controlled trial of febuxostat-a novel , nonpurine , selective , xanthine oxidase inhibitor .


The present study will enroll , at @ medical institutions in Japan , @ Japanese patients aged @ years or older who have hyperuricemia without gouty arthritis , who present CKD stage @ , and whose SUA concentration is @-@ @ mg/dL .


Patients are randomly assigned to either the febuxostat or the control group , in which febuxostat tablets and placebo are administered orally , respectively .


The dosage of the study drugs should be one @-mg tablet/day at weeks @ to @ after study initiation , increased to one @-mg tablet/day at weeks @ to @ , and elevated to one @-mg tablet/day at week @ and then maintained until week @ .


The primary endpoint is estimated glomerular filtration rate ( eGFR ) slope .


The secondary endpoints include the amount and percent rate of change in eGFR from baseline to week @ , the amount and percent rate of change in SUA concentration from baseline to week @ , the proportion of patients who achieved an SUA concentration@ @ mg/dL , and the incidence of renal function deterioration .


The present study aims to examine whether febuxostat prevents a further reduction in renal function as assessed with eGFR in subjects and will ( @ ) provide evidence to indicate the inverse association between a reduction in SUA concentration and an improvement in renal function and ( @ ) rationalize pharmacotherapy for subjects and clarify its clinical relevance .


To compare the efficacy and safety of cutting balloon angioplasty ( CBA ) versus high-pressure balloon angioplasty ( HPBA ) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty ( PTA ) .


In a prospective , randomized clinical trial involving patients with dysfunctional , stenotic hemodialysis arteriovenous fistulas ( AVFs ) , patients were randomized to receive CBA or HPBA if conventional PTA had suboptimal results ( ie , residual stenosis > @ % ) .


A total of @ patients consented to participate in the study from October @ to September @ , @ % of whom ( n = @ ) had technically successful conventional PTA .


The remaining @ patients ( mean age , @ y ; @ men ) with suboptimal PTA results were eventually randomized : @ to the CBA arm and @ to the HPBA arm .


Primary and secondary target lesion patencies were determined by Kaplan-Meier analysis .


Clinical success rates were @ % in both arms .


Primary target lesion patency rates at @ months were @ % and @ % for CBA and HPBA , respectively ( P = @ ) .


Secondary target lesion patency rates at @ months were @ % for CBA and @ % for HPBA ( P = @ ) .


There was a single major complication of venous perforation following CBA .


The @-day mortality rate was @ % , with one non-procedure-related death in the HPBA group .


Primary and secondary target lesion patency rates of CBA were statistically superior to those of HPBA following suboptimal conventional PTA .


For AVF stenoses resistant to conventional PTA , CBA may be a better second-line treatment given its superior patency rates .


To assess the efficacy and safety of aranidipine versus retard-released felodipine in Chinese patients with mild-to-moderate essential hypertension .


This was a multicenter , randomized , double-blind , placebo and active antihypertensive drug parallel-controlled study .


After @ weeks of placebo run-in period , @ patients at @ centers with diastolic blood pressure ( DBP ) between @ to @ mm Hg ( @ mm Hg = @ kPa ) while systolic blood pressure ( SBP ) below @ mm Hg were randomized to receive aranidipine @-@ mg/d ( n = @ ) or retard-released felodipine @-@ mg/d ( n = @ ) for @ weeks .


Others ( n = @ ) received placebo for @ weeks .


Their blood pressures were evaluated at baseline and the end of Weeks @ , @ and @ .


After a @-week treatment , SBP decreased from @ @ mm Hg to ( @ @ ) mm Hg while DBP dropped from ( @ @ ) mm Hg to ( @ @ ) mm Hg .


There were significant differences with the baseline values ( P < @ ) .


After a @-week treatment , the reductions of SBP in aranidipine and retard-released felodipine groups were ( @ @ ) mm Hg and ( @ @ ) mm Hg while the reductions of DBP in two groups ( @ @ ) mm Hg and ( @ @ ) mm Hg respectively .


The reductions of SBP and DBP in two groups were ( @ @ ) mm Hg and ( @ @ ) mm Hg and they were significantly superior to that in placebo group ( P < @ ) .


But no significant difference existed between aranidipine and retard-released felodipine groups .


Also no significant differences were found between these two antihypertensive therapy groups at the end of Weeks @ , @ and @ in the reduction of blood pressure , total response rate and blood pressure control rate .


But @ mg daily aranidipine was significantly superior to @ mg daily retard-released felodipine in the control rates of SBP and DBP .


Adverse events occurred at @ % and @ % in aranidipine and retard-released felodipine groups respectively ( P = @ ) .


Administration of aranidipine @-@ mg/d can effectively control blood pressure and is not inferior to retard-released felodipine @-@ mg/d .


The efficacy of @ mg/d aranidipine is superior to that of retard-released felodipine @-@ mg/d .


And the effectiveness and safety of aranidipine are similar to those of retard-released felodipine .


The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair ( TIMELI ) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain @months post-operatively compared with sutures .


Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention .


Univariate and multivariate analyses identified risk factors for combined pain , numbness and groin discomfort ( PND ) visual analogue scale ( VAS ) score @months post-operatively .


Variables tested were : fixation method , age , employment status , physical activity , nerve handling , PND VAS score at pre-operative visit and @week post-operatively .


The effect of fixation technique on separate PND outcomes @months post-surgery was also assessed .


Analyses included the intention-to-treat ( ITT ) population and a subpopulation with pre-operative PND VAS > @mm .


@ patients were included in the ITT , with @ patients in the subpopulation with pre-operative PND VAS > @ .


Multivariate analysis identified mesh fixation with sutures , worsening pre-operative PND and worsening PND @week post-surgery as significant predictors of @-month PND in the ITT population ; mesh fixation with sutures was a significant predictor of @-month PND in the pre-operative PND VAS > @ subpopulation ( p < @ ) .


Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at @months ; there was no difference in pain between the treatment groups .


Pre-operative discomfort may be an important predictor of post-operative pain , numbness and discomfort .


Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients .


To determine whether abagovomab induces protective immune responses in ovarian cancer patients in first clinical remission .


The present analysis is a substudy of monoclonal antibody immunotherapy for malignancies of the ovary by subcutaneous abagovomab trial ( NCT@ ) .


The study included @ patients , @ in the abagovomab arm and @ in the placebo arm .


Circulating CA@-specific cytotoxic T lymphocytes ( CTL ) were measured by a flow cytometry-based interferon - producing assay .


Human antimouse antibody and anti-anti-idiotypic ( Ab@ ) were assessed by ELISA .


Patients were evaluated before starting the treatment and at different time points during induction and maintenance phases .


A similar percentage of patients in both the placebo and abagovomab arms had CA@-specific CTL ( @ and @ % , respectively ; p = @ by Fisher 's exact test ) .


Patients with CA@-specific CTL in both arms tended to have an increased relapse-free survival ( RFS , log-rank test p = @ ) compared to patients without .


Patients ( n = @ ) in the abagovomab arm without CA@-specific CTL but that developed Ab@ above the cutoff ( defined as median Ab@ level at week @ ) had a prolonged RFS compared to patients ( n = @ ) that did not develop Ab@ above the cutoff ( log-rank test p = @ ) .


Abagovomab does not induce CA@-specific CTL .


However , patients with CA@-specific CTL perform better than patients without , irrespective of abagovomab treatment .


Abagovomab-induced Ab@ associate with prolonged RFS in patients without CA@-specific CTL .


Further studies are needed to confirm these data and to assess the potential utility of these immunological findings as a tool for patient selection in clinical trial .


Indoor exposure to fine particulate matter ( PM@ @ ) from outdoor sources is a major health concern , especially in highly polluted developing countries such as China .


Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas .


This study sought to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health .


We conducted a randomized , double-blind crossover trial among @ healthy college students in Shanghai , China , in @ .


These students lived in dormitories that were randomized into @ groups and alternated the use of true or sham air purifiers for @ h with a @-week washout interval .


We measured @ circulating biomarkers of inflammation , coagulation , and vasoconstriction ; lung function ; blood pressure ( BP ) ; and fractional exhaled nitric .


We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables .


On average , air purification resulted in a @ % reduction in PM@ @ concentration , from @ to @ g/m@ , within hours of operation .


Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers , including @ % in monocyte chemoattractant protein-@ , @ % in interleukin-@ , @ % in myeloperoxidase , and @ % in soluble CD@ ligand .


Furthermore , systolic BP , diastolic BP , and fractional exhaled nitrous oxide were significantly decreased by @ % , @ % , and @ % in geometric mean , respectively .


The impacts on lung function and vasoconstriction biomarkers were beneficial but not statistically significant .


This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young , healthy adults in a Chinese city with severe ambient particulate air pollution .


( Intervention Study on the Health Impact of Air Filters in Chinese Adults ; NCT@ ) .


To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women .


Multicentre randomised trial .


We utilised a central telephone randomisation server , with computer generated schedule , balanced variable blocks , and stratification for parity , body mass index ( BMI ) category , and hospital .


Three public maternity hospitals across South Australia .


@ women with a singleton pregnancy , between @ +@ and @ +@ weeks ' gestation , and BMI @ .


@ women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff ; @ were randomised to standard care and received pregnancy care according to local guidelines , which did not include such information .


Incidence of infants born large for gestational age ( birth weight @th centile for gestation and sex ) .


Prespecified secondary outcomes included birth weight > @ g , hypertension , pre-eclampsia , and gestational diabetes .


Analyses used intention to treat principles .


@ women and @ liveborn infants were included in the analyses .


The risk of the infant being large for gestational age was not significantly different in the two groups ( lifestyle advice @/@ ( @ % ) v standard care @/@ ( @ % ) ; adjusted relative risk @ , @ % confidence interval @ to @ ; P = @ ) .


Infants born to women after lifestyle advice were significantly less likely to have birth weight above @ g ( lifestyle advice @/@ ( @ % ) v standard care @/@ ( @ % ) ; @ , @ to @ ; number needed to treat ( NNT ) @ , @ to @ ; P = @ ) .


There were no differences in maternal pregnancy and birth outcomes between the two treatment groups .


For women who were overweight or obese , the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the @th centile for gestational age and sex or improve maternal pregnancy and birth outcomes .


Observationally lower testosterone is associated with an unhealthier cardiovascular ( CVD ) risk profile , but this association is open to confounding and reverse causality .


The authors examined the association of testosterone with well-established cardiovascular disease ( CVD ) risk factors ( blood pressure , low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol and fasting glucose ) and the Framingham score using a Mendelian randomization analysis with a separate-sample instrumental variable estimator .


To minimize reverse causality , a genetic score predicting testosterone was developed in @ young Chinese men from Hong Kong , based on three selected testosterone-related single nucleotide polymorphisms ( rs@ , rs@ and rs@ ) .


Multivariable censored and linear regressions were used to examine the association of genetically predicted testosterone levels with CVD risk factors and Framingham score among @ older Chinese men from the Guangzhou Biobank Cohort Study .


Predicted testosterone was unrelated to systolic blood pressure -LSB- -@ mmHg , @ % confidence interval ( CI ) -@ to @ -RSB- , diastolic blood pressure ( @ mmHg , @ % CI -@ to @ ) , fasting glucose ( @ mmol/l , @ % CI -@ to @ ) or Framingham score ( @ , @ % CI -@ to @ ) but associated with higher LDL-cholesterol ( @ mmol/l , @ % CI @ to @ ) and lower HDL-cholesterol ( -@ mmol/l , @ % CI -@ to -@ ) , after adjustment for potential confounders ( age , education , smoking status , use of alcohol and body mass index ) .


Our findings did not corroborate observed protective effects of testosterone on cardiovascular risk factors or risk of ischaemic heart disease among men , but raises the possibility that higher testosterone may be associated with an unhealthier lipid profile .


Rehabilitation of impaired cognitive functions begins to be considered a standard component of medical care after acquired brain injury .


Indeed , many evidences support the effectiveness of the two major categories of techniques , i.e. the traditional and computer-assisted ones , which are widely used in cognitive rehabilitative treatment .


Aim of this study is to evaluate the effects of pc - cognitive training in brain injury patients .


We studied @ subjects ( randomly divided into two groups ) , affected by traumatic or vascular brain injury , having attended from January @ to December @ the Laboratory of Robotic and Cognitive Rehabilitation of IRCCS Neurolesi of Messina .


Cognitive impairment was investigated through psychometric battery , administered before ( T@ ) and two months ( T@ ) after the cognitive pc-training , which was performed only by the experimental group , in addition to conventional treatment .


Statistical analysis was performed using Wilcoxon test with a p < @ .


At time T@ , all patients showed language deficits and cognitive alterations in visual attention and memory abilities .


After the rehabilitation program we noted a global improvement in both the groups .


However , at T@ , the experimental group showed a greater cognitive improvement than the control group , with significant differences in nearly all the neuropsychological tests performed .


Our data suggest that cognitive pc-training may be a promising methodology to optimize the rehabilitation outcomes following brain injury .


Study C@ was a Phase IIa , exploratory trial to assess the activity of telaprevir on hepatitis C virus ( HCV ) early viral kinetics in treatment-nave patients infected with genotype @ ( G@ ) HCV .


Patients were randomized to receive peginterferon and ribavirin alone , telaprevir monotherapy ( T arm ) , or telaprevir in combination with peginterferon/ribavirin ( TPR arm ) for @days , followed by a @ - or @-week standard treatment phase .


The current analysis aimed to characterize the genotype and phenotype of HCV G@ variants emerging during telaprevir treatment .


Five of the @ ( @ % ) patients in the telaprevir ( T ) arm had viral breakthrough ( vBT ) during the investigational treatment phase ( between baseline and Day @ ) , compared to no patients in the TPR arm .


HCV G@ viral variants with a T@A/T mutation were detected in two of these patients , as well as two other patients with detectable HCV RNA at the end of telaprevir treatment .


Emergence of the T@A/T mutation was associated with a @ - to @-fold decreased susceptibility to telaprevir .


All patients with vBT during the investigational treatment phase or with a T@A/T mutation achieved undetectable HCV RNA @ or @weeks after end of treatment with subsequent peginterferon/ribavirin treatment .


In this analysis in G@ HCV-infected patients , more patients in the telaprevir monotherapy arm experienced vBT with resistant variants compared to none with telaprevir combination therapy .


The most commonly selected mutation T@A in telaprevir-treated G@ HCV patients was previously described in the context of G@ infection .


The objective was to assess associations between tenofovir disoproxil fumarate-emtricitabine ( TDF-FTC ) exposure and levonorgestrel ( LNG ) concentrations among Kenyan HIV prevention trial participants using Sino-implant ( II ) LNG implants for contraception .


Women were offered implants among other contraceptive methods , were randomized to daily TDF-FTC or placebo , and followed monthly up to @weeks .


Associations between TDF-FTC exposure and mean LNG values were analyzed with linear mixed models .


Of @ women , @ ( @ % ) received implants with no incident pregnancies and one discontinuation .


Mean LNG concentrations over @weeks among @ women contributing data ranged between @ and @ pg/mL with no significant difference between TDF-FTC and placebo arms or between variable levels of TDF-FTC adherence .


Concomitant TDF-FTC use was not associated with a significant change in plasma LNG concentrations among women using Sino-implant ( II ) in the first year of use .


In low-tumor burden follicular lymphoma ( FL ) , maintenance rituximab ( MR ) has been shown to improve progression-free survival when compared with observation .


It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab ( RR ) administered on an as-needed basis .


E@ ( RESORT ) was a randomized clinical trial designed to compare MR against RR .


Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab , and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure .


Patients assigned to MR received a single dose of rituximab every @ months until treatment failure .


The primary end point was time to treatment failure .


Secondary end points included time to first cytotoxic therapy , toxicity , and health-related quality of life ( HRQOL ) .


A total of @ patients were randomly assigned to RR or MR. With a median follow-up of @ years , the estimated median time to treatment failure was @ years for patients receiving RR and @ years for those receiving MR ( P = @ ) .


Three-year freedom from cytotoxic therapy was @ % for those receiving RR and @ % for those receiving MR ( P = @ ) .


The median number of rituximab doses was four patients receiving RR and @ for those receiving MR. There was no difference in HRQOL .


Grade @ to @ toxicities were infrequent in both arms .


In low-tumor burden FL , a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy .


The impact of perioperative synbiotics on bacterial translocation and subsequent bacteraemia after oesophagectomy is unclear .


This study investigated the effect of perioperative synbiotic administration on the incidence of bacterial translocation to mesenteric lymph nodes ( MLNs ) and the occurrence of postoperative bacteraemia .


Patients with oesophageal cancer were randomized to receive perioperative synbiotics or no synbiotics ( control group ) .


MLNs were harvested from the jejunal mesentery before dissection ( MLN-@ ) and after the restoration of digestive tract continuity ( MLN-@ ) .


Blood and faeces samples were taken before and after operation .


Microorganisms in each sample were detected using a bacterium-specific ribosomal RNA-targeted reverse transcriptase-quantitative polymerase chain reaction ( RT-qPCR ) method .


Some @ patients were included .


There was a significant difference between the two groups in detection levels of microorganisms in the MLN-@ samples .


Microorganisms were more frequently detected in MLN-@ samples in the control group than in the synbiotics group ( @ of @ versus @ of @ ; P = @ ) .


In addition , bacteraemia detected using RT-qPCR @day after surgery was more prevalent in the control group than in the synbiotics group ( @ of @ versus @ of @ ; P = @ ) .


Neutrophil counts on postoperative days @ , @ and @ after surgery were all significantly higher in the control group than in the synbiotics group .


Perioperative use of synbiotics reduces the incidence of bacteria in the MLNs and blood .


These beneficial effects probably contribute to a reduction in the inflammatory response after oesophagectomy .


Population sequencing ( PS ) has shown that telaprevir-resistant variants are not typically detectable at baseline ( prevalence , @ % of patients ) , and most variants present at the time of treatment failure are no longer detectable at the end of the study .


To gain insight into the evolution of telaprevir-resistant variants , their baseline prevalence and persistence after treatment was investigated using a more sensitive , deep-sequencing ( DS ) technique in a large number of treatment-experienced patients from the REALIZE study who were infected with hepatitis C virus genotype @ .


Before treatment initiation , telaprevir-resistant variants ( T@A , T@S , or R@K in @ % -@ % of the viral population ) were detected by DS in a fraction ( @ % ) of patients for whom PS failed to detect resistance ; these variants were not necessarily detected at the time of treatment failure .


Of @ patients in whom telaprevir-resistant variants were detected by PS at the time of treatment failure but not at the end of the study , DS revealed the presence of variants ( V@A/L/M , T@S , or R@K in @ % -@ % of the viral population ) in @ patients ( @ % ) at the end of the study .


Similar to PS findings , DS analysis revealed that the frequency of telaprevir-resistant variants before treatment was also low , and variants detected at the time of treatment failure were no longer detectable in the majority of patients during follow-up .


Abnormal forms of grief , currently referred to as complicated grief or prolonged grief disorder , have been discussed extensively in recent years .


While the diagnostic criteria are still debated , there is no doubt that prolonged grief is disabling and may require treatment .


To date , few interventions have demonstrated efficacy .


We investigated whether outpatients suffering from prolonged grief disorder ( PGD ) benefit from a newly developed integrative cognitive behavioural therapy for prolonged grief ( PG-CBT ) .


A total of @ patients were randomized into two groups , stratified by the type of death and their relationship to the deceased ; @ patients composed the treatment group and @ patients composed the wait list control group ( WG ) .


Treatment consisted of @-@ sessions .


Main outcome was change in grief severity ; secondary outcomes were reductions in general psychological distress and in comorbidity .


Patients on average had @ comorbid diagnoses in addition to PGD .


Between group effect sizes were large for the improvement of grief symptoms in treatment completers ( Cohens d = @ ) and in the intent-to-treat analysis ( d = @ ) .


Comorbid depressive symptoms also improved in PG-CBT compared to WG .


The completion rate was @ % in PG-CBT and @ % in WG .


The major limitations of this study were a small sample size and that PG-CBT took longer than the waiting time .


PG-CBT was found to be effective with an acceptable dropout rate .


Given the number of bereaved people who suffer from PGD , the results are of high clinical relevance .


The first CE-approved bioresorbable vascular scaffold ( BVS ) is effective at treating simple lesions and stable coronary artery disease , but it has yet to be assessed versus the best-in-class drug-eluting stents ( DES ) .


This study sought to compare the performance of a BVS with that of everolimus-eluting stents ( EES ) and biolimus-eluting stents ( BES ) in all-comer patients .


The EVERBIO II ( Comparison of Everolimus - and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II ) trial was a single-center , assessor-blinded study of @ patients randomly assigned in a @:@:@ ratio to EES , BES , or BVS .


The only exclusion criterion was a reference vessel diameter > @ mm , which precluded treatment with BVS .


The primary endpoint was angiographic late lumen loss ( LLL ) at @ months .


Secondary endpoints included patient-oriented major acute coronary events ( MACE ) ( death , myocardial infarction -LSB- MI -RSB- , and any revascularization ) , device-oriented MACE ( cardiac death , MI , and target lesion revascularization ) , and stent thrombosis at the @-month clinical follow-up .


Follow-up angiography was performed in @ patients ( @ % ) at @ months .


In-stent LLL was similar between patients treated with BVS ( @ @ mm ) and those treated with EES/BES ( @ @ mm ; p = @ ) .


Clinical outcomes were similar at @ months : the patient-oriented MACE rate was @ % in BVS and @ % in the EES/BES group ( p = @ ) and the device-oriented MACE rate was @ % in BVS and @ % in the EES/BES group ( p = @ ) .


New-generation metallic DES ( EES/BES ) were not superior to BVS in terms of angiographic LLL and clinical outcomes .


( Comparison of Everolimus - and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents -LSB- EVERBIO II -RSB- ; NCT@ ) .


Common clinical practice recommends dual antiplatelet therapy ( DAPT ) for transcatheter aortic valve implantation ( TAVI ) .


The aim of the study was to evaluate , in a double blind randomized study , the safety of TAVI , with adjunctive pharmacotherapy consisting of single antiplatelet therapy .


From April @ to April @ , @ consecutive patients , undergoing TAVI , have been enrolled in the study .


Patients were randomly assigned to DAPT group ( aspirin and clopidogrel @ mg/qd or ticlopidine @ mg/bid ) or ASA group ( aspirin only ) .


TAVI device was the Sapien XT-Novaflex Delivery System ( Edwards Lifesciences , Inc. ) .


All patients were followed up to @ months .


Device success was achieved in @ % of patients .


No difference in the VARC combined @ day safety endpoint , all cause and cardiovascular mortality was observed .


At @ days vascular complications were reduced in the ASA group ( p < @ ) .


No differences in the clinical status were detected between the groups up to @ months .


This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality .


These findings , if confirmed in a larger multicenter randomized trial , will no longer support the use of DAPT for TAVI .


Patients with @p/@q codeleted anaplastic oligodendroglial tumors who participated in RTOG ( Radiation Therapy Oncology Group ) @ lived much longer after chemoradiotherapy ( CRT ) than radiation therapy ( RT ) alone .


However , some patients with noncodeleted tumors also benefited from CRT ; survival curves separated after the median had been reached , and significantly more patients lived @ years after CRT than RT. .


Thus , @p/@q status may not identify all responders to CRT .


Using trial data , we inquired whether an IDH mutation or germ-line polymorphism associated with IDH-mutant gliomas identified the patients in RTOG @ who benefited from CRT .


IDH status was evaluable in @ of @ patients ; @ ( @ % ) had mutations .


rs@ was evaluable in @ patients ; @ ( @ % ) carried the G risk allele .


Both were associated with longer progression-free survival after CRT , and mutant IDH was associated with longer overall survival ( @ v @ years ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ) .


For those with wild-type tumors , CRT did not prolong median survival ( @ v @ years ; HR , @ ; @ % CI , @ to @ ; P = @ ) or @-year survival rate ( CRT , @ % v RT , @ % ) .


Patients with codeleted mutated tumors ( @ v @ years ; HR , @ ; @ % CI , @ to @ ; P = @ ) and noncodeleted mutated tumors ( @ v @ years ; HR , @ ; @ % CI , @ to @ ; P < @ ) lived longer after CRT than RT. .


IDH mutational status identified patients with oligodendroglial tumors who did ( and did not ) benefit from alkylating-agent chemotherapy with RT. .


Although patients with codeleted tumors lived longest , patients with noncodeleted IDH-mutated tumors also lived longer after CRT .


Despite the widespread use and advancements of mobile technology that facilitate rich communication modes , there is little evidence demonstrating the value of smartphones for effective interclinician communication and knowledge processes .


The objective of this study was to determine the effects of different synchronous smartphone-based modes of communication , such as ( @ ) speech only , ( @ ) speech and images , and ( @ ) speech , images , and image annotation ( guided noticing ) on the recall and transfer of visually and verbally represented medical knowledge .


The experiment was conducted from November @ to May @ at the University Hospital Basel ( Switzerland ) with @ medical students in a master 's program .


All participants analyzed a standardized case ( a patient with a subcapital fracture of the fifth metacarpal bone ) based on a radiological image , photographs of the hand , and textual descriptions , and were asked to consult a remote surgical specialist via a smartphone .


Participants were randomly assigned to @ experimental conditions/groups .


In group @ , the specialist provided verbal explanations ( speech only ) .


In group @ , the specialist provided verbal explanations and displayed the radiological image and the photographs to the participants ( speech and images ) .


In group @ , the specialist provided verbal explanations , displayed the radiological image and the photographs , and annotated the radiological image by drawing structures/angle elements ( speech , images , and image annotation ) .


To assess knowledge recall , participants were asked to write brief summaries of the case ( verbally represented knowledge ) after the consultation and to re-analyze the diagnostic images ( visually represented knowledge ) .


To assess knowledge transfer , participants analyzed a similar case without specialist support .


Data analysis by ANOVA found that participants in groups @ and @ ( images used ) evaluated the support provided by the specialist as significantly more positive than group @ , the speech-only group ( group @ : mean @ , SD @ ; group @ : mean @ , SD @ ; group @ : mean @ , SD @ ; F@ ,@ = @ , P = @ ; partial ( @ ) = @ , @ - = @ ) .


However , significant positive effects on the recall and transfer of visually represented medical knowledge were only observed when the smartphone-based communication involved the combination of speech , images , and image annotation ( group @ ) .


There were no significant positive effects on the recall and transfer of visually represented knowledge between group @ ( speech only ) and group @ ( speech and images ) .


No significant differences were observed between the groups regarding verbally represented medical knowledge .


The results show ( @ ) the value of annotation functions for digital and mobile technology for interclinician communication and medical informatics , and ( @ ) the use of guided noticing ( the integration of speech , images , and image annotation ) leads to significantly improved knowledge gains for visually represented knowledge .


This is particularly valuable in situations involving complex visual subject matters , typical in clinical practice .


This study investigated whether maintenance temozolomide ( TMZ ) after definitive therapy for locally advanced non-small-cell lung cancer ( NSCLC ) could decrease the incidence of brain metastasis ( BM ) .


Eligible patients included those with stage IIIA , IIIB , or IV ( for stage IV , only with malignant pleural/pericardial effusion ) NSCLC with no BM at diagnosis and stable disease , partial response , or complete response after first-line chemotherapy using at least @ agents .


Patients were randomized to observation or TMZ ( @ mg/m ( @ ) for @ consecutive days followed by a @-day rest for up to @ cycles or progression ) .


The primary end point was incidence of radiographically diagnosed BM within @ months from day @ of first-line chemotherapy .


Secondary end points included overall survival ( OS ) , time to progression , incidence of BM at first progression , and toxicity .


The study was closed early on the basis of a futility analysis ; @ of @ enrolled patients were evaluable from an original target of @ .


No difference was noted in the incidence of BM at @ year in the TMZ and observation groups ( @ % and @ % , respectively ) , in median time to progression ( @ and @ months , respectively ) , or in median OS ( @ and @ months , respectively ) .


Common Terminology Criteria for Adverse Events grade @ or @ adverse events were @ % in the TMZ group and @ % in the observation group .


TMZ monotherapy does not appear to decrease the incidence of BM in patients with locally advanced NSCLC .


These results considered in the context of the existing literature have implications for future clinical trial design .


The international multicentre FAME Study ( n = @,@ ) demonstrated significant health benefits for patients undergoing multivessel percutaneous coronary intervention ( PCI ) guided by fractional flow reserve ( FFR ) measurement compared with angiography guidance alone ( ANGIO ) .


We determined the cost-effectiveness and the public health/budget impact for Australia .


We performed a prospective economic evaluation comparing FFR vs. ANGIO in patients with multivessel disease based on original patient-level FAME data .


We used Australian utilities ( EQ-@D ) and costs to calculate quality-adjusted life years ( QALYs ) and incremental cost-effectiveness adopting the societal perspective .


The public health and budget impact from the payer 's perspective was based on Australian PCI registries .


Uncertainty was explored using deterministic sensitivity analyses and the bootstrap method ( n = @,@ samples ) .


The cost-effectiveness analysis showed that FFR was cost-saving and reduces costs by @,@ AUD per patient during one year .


Over a two-year time horizon , the public health impact ranged from @ to @ QALYs gained and the budget impact from @ to @ million AUD total cost savings .


Sensitivity analyses demonstrated that FFR was cost-saving over a wide range of assumptions .


FFR-guided PCI in patients with multivessel coronary disease substantially reduces cardiac events , improves QALYs and is cost-saving in the Australian health care system .


This study aimed to evaluate the feasibility of non-contrast-enhanced @D magnetic resonance angiography ( NCE @D MRA ) with signal targeting with alternative radiofrequency ( STAR ) spin labeling and variable flip angle ( VFA ) sampling in the assessment of dural arteriovenous fistula ( DAVF ) in the transverse sinus .


Nine patients underwent NCE @D MRA for the evaluation of DAVF in the transverse sinus at @T .


One patient was examined twice , once before and once after the interventional treatment .


All patients also underwent digital subtraction angiography ( DSA ) and/or contrast-enhanced magnetic resonance angiography ( CEMRA ) .


For the acquisition of NCE @D MRA , a STAR spin tagging method was used , and a VFA sampling was applied in the data readout module instead of a constant flip angle .


Two readers evaluated the NCE @D MRA data for the diagnosis of DAVF and its type with consensus .


The results were compared with those from DSA and/or CEMRA .


All patients underwent NCE @D MRA without any difficulty .


Among seven patients with patent DAVFs , all cases showed an early visualization of the transverse sinus on NCE @D MRA .


Except for one case , the type of DAVF of NCE @D MRA was agreed with that of reference standard study .


Cortical venous reflux ( CVR ) was demonstrated in two cases out of three patients with CVR .


NCE @D MRA with STAR tagging and VFA sampling is technically and clinically feasible and represents a promising technique for assessment of DAVF in the transverse sinus .


Further technical developments should aim at improvements of spatial and temporal coverage .


Non-cystic fibrosis bronchiectasis is characterized by the irreversible dilatation of the medium-sized bronchi as a result of airway injury from recurrent or chronic inflammation and lower respiratory tract infections .


Bronchiectasis airways are commonly colonized with bacterial species .


Infections of the airways play important role in bronchiectasis exacerbations .


The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing interest .


OM-@ , consisting of extracts of eight kinds of bacteria important in respiratory infections , could support the respiratory tract resistance to the pathogens .


OM-@ has been shown to be a benefit by decreasing the risk of acute exacerbation of chronic obstructive pulmonary disease ( COPD ) in several perspective clinical trials .


Exacerbation of bronchiectasis substantially contributes to a more rapid decline in lung function , reduced quality of life , and healthcare costs .


In this context , we plan to conduct a clinical trial to investigate the PReventive effect of OM-@ on Bronchiectasis Exacerbation in Chinese patients ( iPROBE ) .


This study is designed as a prospective , randomized , double blind , placebo-controlled multicenter trial .


A total of @ patients with bronchiectasis , who have had at least one exacerbation of bronchiectasis in the previous year , will be included .


The subjects will randomly receive two courses of @ mg of OM-@ or a matching placebo .


The treatment dose of OM-@ will be one daily capsule taken orally for @ days each month for @ consecutive months at the beginning of the study , followed by @ months of no drug .


This schedule will repeat until the patient has been seen for one year .


We will investigate whether long-term treatment with an oral immunostimulant ( OM-@ ) could decrease exacerbations of bronchiectasis over a one-year period .


We will also assess other relevant outcomes , including the rate of event-based exacerbation , lung function parameters , and total scores judged by the St George 's respiratory questionnaire , Leicester cough questionnaire , and inflammatory index .


We hope that this study will provide new information on the preventive effects of OM-@ on bronchiectasis exacerbations and will address a knowledge gap for this understudied disease .


Dipeptidyl peptidase ( DPP ) -@ inhibitors and sulfonylureas may have different effects on islet function .


We designed a new two-step hyperglycemic clamp to further compare the effects of sitagliptin , saxagliptin , and glimepiride on - cell function and the incretin effect .


The present study was a four-way cross-over open label randomized study .


Twelve healthy male subjects were administered a single dose of sitagliptin ( @mg ) , saxagliptin ( @mg ) , glimepiride ( @mg ) or blank control @h before undergoing a two-step hyperglycemic clamp ( Step @ : only intravenous glucose was administered ; Step @ : i.v. glucose loading was combined with oral glucose consumption ) .


Two-phase insulin secretion , glucagon secretion , and incretin levels were measured during the clamp .


In Step @ , with i.v. glucose only , there were no differences between the effects of the three drugs on insulin secretion , except that saxagliptin increased second-phase insulin secretion more than glimepiride ( P = @ ) .


In Step @ , oral glucose consumption led to an approximate two fold increase in insulin secretion and both gliptins significantly increased first-phase insulin secretion compared with glimepiride ( P = @ for both ) .


Saxagliptin further increased second-phase insulin secretion compared with glimepiride ( P = @ ) and sitagliptin ( P < @ ) .


Both gliptins significantly decreased glucagon secretion and increased active glucagon-like peptide-@ ( GLP-@ ) compared with glimepiride , especially in Step @ .


The two-step hyperglycemic clamp appears to be a precise method to assess - cell function by taking the effect of incretins into consideration .


The oral glucose consumption adds to the i.v. glucose infusion , amplifying the differences in the effects of DPP-@ inhibitors and glimepiride on insulin secretion .


Exercise induces oxidative stress and causes adaptations in antioxidant defenses .


The aim of the present study was to determine the effects of a @-month diet supplementation with docosahexaenoic acid ( DHA ) on the pro-oxidant and antioxidant status of peripheral blood mononuclear cells ( PBMCs ) during football training and after acute exercise .


Fifteen male football players , in a randomized double-blind trial , ingested a beverage enriched with DHA or a placebo for @ weeks .


Blood samples were collected in basal conditions before and after the training period and after an acute and intense exercise .


The training season increased the carbonyl and nitrotyrosine index but decreased the malondialdehyde ( MDA ) levels .


Basal catalase activity decreased in both groups after @ weeks of training , whereas glutathione peroxidase activity increased mainly in the placebo group .


Protein levels of uncoupling proteins ( UCP@ and UCP@ ) and inducible nitric oxide synthase significantly increased after the training period .


Acute exercise induced redistribution in the number of circulating cells , increased the MDA levels and nitrotyrosine index , and decreased the levels of nitrate .


Acute exercise also increased PBMCs reactive oxygen species ( ROS ) production after immune stimulation .


Diet supplementation with DHA significantly increased the UCP@ levels after training and the superoxide dismutase protein levels after acute exercise , and reduced the production of ROS after acute exercise .


Docosahexaenoic acid increased the antioxidant capabilities while reducing the mitochondrial ROS production in a regular football training period and reduced the oxidative damage markers in response to acute exercise .


Prospective randomized study .


To compare autologous bone marrow concentrate mixed with allograft cancellous bone to iliac crest autograft in lumbar fusions .


Bone marrow has been shown to be a rich source of osteoprogenitor cells .


Osteoprogenitor cells have been shown in animals , and some human studies , to have potential in use as a bone graft substitute .


Twenty-five patients underwent from @ - to @-level lumbar fusions .


One patient was lost to follow-up .


On one half of the spine , allograft plus autologous bone marrow concentrate was used , whereas on the other half , autologous iliac crest bone was used .


Cellular analysis , consisting of nucleated cell count , mononuclear cell count , CD@ + count , and colony-forming-units-fibroblast count , was done on marrow aspirates and concentrates .


At @ year postoperation , computed tomographic scans of the fusions were evaluated on a blinded basis by @ neuroradiologists independent of each other .


Radiographical fusion was the primary outcome measure .


There was no statistical difference in fusion scores between allograft and autograft in the lateral gutters , interbody cages , or facet joints .


There was a positive trend between CD@ + counts and radiographical fusion .


The study shows equivalence between cancellous allograft mixed with bone marrow concentrate and autologous iliac crest bone for lumbar fusions .


Platinum-resistant ovarian cancer ( PROC ) constitutes a therapeutic dilemma with limited efficacy from traditional cytotoxic agents .


Based on prior data suggesting that scheduling alterations of platinum would increase activity , the aim of the present study was to assess the potential therapeutic benefit of phenoxodiol ( PXD ) , a novel biomodulator shown to have chemoresistance reversing potential , when combined with weekly AUC@-carboplatin in PROC patients .


A multicenter randomized double-blind placebo controlled phase-III-study was conducted to compare oral PXD plus AUC@-carboplatin ( group @ ) versus placebo plus AUC@-carboplatin ( group @ ) weekly in PROC patients .


The primary end point was progression-free-survival ( PFS ) .


Secondary objectives included overall survival ( OS ) , response rates , duration of response and quality of life .


The study was terminated early @ April @ , after recruitment of @ patients due to feasibility and recruitment challenges .


A total of @ patients were randomized .


The groups were well balanced in terms of important baseline characteristics .


The median PFS for group @ was @ weeks -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- versus @ weeks for group @ ( @ % CI = @-@ @ ) ; P = @ .


The objective response rate and median survival in group @ versus group @ was @ % versus @ % and @ weeks ( @ % CI @-@ @ ) versus @ weeks ( @ % CI @-@ @ ) , respectively .


PXD appeared to be well tolerated .


The main reason for dose modification in both groups was hematologic toxicity .


Orally delivered PXD showed no evidence of clinical activity , when combined with weekly AUC@-carboplatin in PROC .


In addition , single-agent weekly AUC@-carboplatin appeared to be inactive by response criteria in a homogenously defined population of PROC .


This has implications for the design of future studies .


Left-ventricular ejection fraction ( LVEF ) is regarded as a strong predictor for morbidity and mortality in heart failure patients .


The aim of the analysis was to assess the relationship between pre-implant LVEF and outcome of patients with advanced heart failure who received cardiac resynchronization therapy ( CRT ) .


We analysed the two-year follow-up of @ patients who had been enrolled in the MASCOT study which included NYHA class III/IV patients with a class I CRT indication .


Pre-implant LVEF was stratified by tertile .


The boundaries for pre-implant LVEF were < @ % ( n = @ ; @ + / - @ % ; T ( low ) ) , @ % to @ % ( n = @ ; @ + / - @ % ; T ( middle ) ) and > @ % ( n = @ ; @ + / - @ % ; T ( high ) ) for each tertile.Two-year post-implant LVEF was @ + / - @ % ( T ( low ) ) , @ + / - @ % ( T ( middle ) ) and @ + / - @ % ( T ( high ) ) .


T ( Iow ) had a greater increase between pre - and post-implant LVEF compared to T ( middle ) ( P = @ ) and T ( high ) ( P = @ ) .


NYHA class improved similarly among the three groups as well as the quality of life score .


No significant differences were detected between the three groups for all-cause mortality , cardiac death , all-cause hospitalization , and hospitalization due to worsening heart failure .


Symptomatic heart failure patients with a wide QRS complex and a severe impaired LV function had a better improvement of their pre-implant LVEF than patients with a more preserved LVEF .


This may be one reason that in these patient groups long-term morbidity and mortality were not related to their pre-implant LVEF .


Pre-implant LVEF was in symptomatic CRT patients not predictive for their long-term cardiovascular morbidity and mortality .


To examine the antihypertensive effect of the synthetic analogue of the endogenous nitric oxide donors in patients with grades @-@ hypertension and uncomplicated hypertensive crisis ( HC ) .


The study included @ male patients aged @ to @ years ( mean age @ @ years ) .


All the patients had grades @-@ essential or secondary hypertension .


Thirteen ( @ % ) patients were observed to have signs of HC ; @ ( @ % ) patients had persistent blood pressure ( BP ) elevation .


A dinitrosyl iron complex was injected in a dose of @ or @ mg per kg of body weight .


The purpose of its administration was to lower BP by at least @ % of its baseline level .


No significant side effects associated with the administration of the test drug were recorded when the clinical trial protocol was implemented .


All the patients reported fever and facial hyperemia during and @-@ minutes after injection .


They all ( @ % ) showed efficient blood pressure reduction of at least @ % of the baseline level .


Blood pressure changes were similar when the agent was administered in doses of @ or @ mg/kg .


At @-@ minutes after the drug was injected , there was a maximal decrease in blood pressure , then its gradual rise and stabilization at a lower level than the baseline one within the following @ hours .


There were no significant differences in the magnitude of a blood pressure reduction after administration of @ and @ mg/kg .


The findings suggest that the dinitrosyl iron complex is highly effective in treating uncomplicated HC .


The antihypertensive effect of the drug persists for @ hours after its injection , which is very important during prehospital therapy .


The drug is well tolerated by patients and causes an insignificant number of side effects .


Determine whether stress in preterm infants , measured with salivary cortisol , decreases after five days of Kangaroo Care ( KC ) compared to five days of Standard Care ( SC ) .


To determine whether kangaroo care provides sustainable pain relief beyond the period of skin-to-skin holding .


Preterm infants ( n = @ ) born at @-@ weeks gestational age were randomized to either the KC or the SC group and received the allocated intervention starting on day of life ( DOL ) five and continuing for five days .


Salivary cortisol was collected on DOL five and again on DOL ten .


Differences were analyzed using repeated measures ANOVA and t tests .


Pain during nasal suctioning over five days was assessed using the Premature Infant Pain Profile ( PIPP ) .


Adequate saliva samples for salivary cortisol were collected for @ KC infants and @ SC infants .


There was no main effect of group ( p = @ ) , but there was a significant main effect of age ( DOL five versus DOL ten ) , with salivary cortisol levels decreasing in both groups ( p = @ ) .


Pain scores for both groups ( n = @ ) indicted mild to moderate pain during suctioning , with no significant difference in pain scores between groups .


KC did not affect salivary cortisol levels in preterm neonates , but levels in both the KC and SC groups decreased over time from DOL five to ten .


Salivary cortisol may vary with age of infant .


Infants experience pain during routine suctioning and may require pain management .


Dexamethasone ( DEXA ) is commonly used to reduce brain swelling during neurosurgical procedures .


DEXA , however , has many side-effects that can increase the risks of post-operative complications .


In contrast , progesterone ( PRO ) has fewer side-effects and has been found to be neuroprotective on traumatic brain injury ( TBI ) .


Whether PRO may be used as an alternative to DEXA during routine procedures has not been fully explored .


To compare the effects of DEXA and PRO on surgical brain injury ( SBI ) .


Seventy-five adult male Sprague Dawley rats were randomized into five groups : ( @ ) SBI + drug vehicle ( peanut oil , @ml kg ( -@ ) ) ; ( @ ) SBI + DEXA ( @mg kg ( -@ ) ) ; ( @ ) SBI + low-dose PRO ( @mg kg ( -@ ) ) ; ( @ ) SBI + high-dose PRO ( @mg kg ( -@ ) ) ; and ( @ ) sham SBI + drug vehicle .


Magnetic resonance imaging study and assessments of brain water content ( BWC ) , blood-brain barrier ( BBB ) permeability , cellular inflammatory responses and matrix metalloproteinase @ ( MMP-@ ) expression were conducted .


This model consistently resulted in increased BWC and BBB disruption .


PRO reduced astrocyte and microglia responses and attenuated brain oedema with preservation of BBB .


A significant down-regulation of MMP-@ expression occurred in the PRO @ group .


PRO is as effective as DEXA in reducing brain oedema and inflammation following SBI ; @mg kg ( -@ ) of PRO was demonstrated to be more effective in relieving acute cellular inflammatory responses .


To assess in multiple sclerosis ( MS ) the effect of intense immunosuppression followed by autologous hematopoietic stem cells transplantation ( AHSCT ) vs mitoxantrone ( MTX ) on disease activity measured by MRI .


We conducted a multicenter , phase II , randomized trial including patients with secondary progressive or relapsing-remitting MS , with a documented increase in the last year on the Expanded Disability Status Scale , in spite of conventional therapy , and presence of one or more gadolinium-enhancing ( Gd + ) areas .


Patients were randomized to receive intense immunosuppression ( mobilization with cyclophosphamide and filgrastim , conditioning with carmustine , cytosine-arabinoside , etoposide , melphalan , and anti-thymocyte globulin ) followed by AHSCT or MTX @ mg every month for @ months .


The primary endpoint was the cumulative number of new T@ lesions in the @ years following randomization .


Secondary endpoints were the cumulative number of Gd + lesions , relapse rate , and disability progression .


Safety and tolerability were also assessed .


Twenty-one patients were randomized and @ had postbaseline evaluable MRI scans .


AHSCT reduced by @ % the number of new T@ lesions as compared to MTX ( rate ratio @ , p = @ ) .


It also reduced Gd + lesions as well as the annualized relapse rate .


No difference was found in the progression of disability .


Intense immunosuppression followed by AHSCT is significantly superior to MTX in reducing MRI activity in severe cases of MS. These results strongly support further phase III studies with primary clinical endpoints .


The study was registered as EUDRACT No. @-@-@ .


Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality .


We aimed to assess the feasibility , effectiveness , and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries .


In this @-month , cluster-randomised trial , we randomly assigned ( @:@ ) rural and semi-urban clusters within six countries ( Argentina , Guatemala , India , Kenya , Pakistan , and Zambia ) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids .


The primary outcome was @-day neonatal mortality among infants less than the @th percentile for birthweight ( a proxy for preterm birth ) across the clusters .


Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes .


This trial is registered with ClinicalTrials.gov , number NCT@ .


The ACT trial took place between October , @ , and March , @ ( start dates varied by site ) .


@ intervention clusters with @,@ livebirths ( @ -LSB- @ % -RSB- less than @th percentile for birthweight ) and @ control clusters with @,@ livebirths ( @ -LSB- @ % -RSB- less than @th percentile ) completed follow-up .


@ ( @ % ) of @ women in intervention clusters who delivered less-than-@th-percentile infants received antenatal corticosteroids , compared with @ ( @ % ) of @ in control clusters ( p < @ ) .


Among the less-than-@th-percentile infants , @-day neonatal mortality was @ per @ livebirths for the intervention group and @ per @ livebirths for the control group ( relative risk -LSB- RR -RSB- @ , @ % CI @-@ , p = @ ) and suspected maternal infection was reported in @ ( @ % ) of @ women in the intervention group and @ ( @ % ) of @ in the control group ( odds ratio -LSB- OR -RSB- @ , @-@ , p < @ ) .


Among the whole population , @-day neonatal mortality was @ per @ livebirths for the intervention group and @ per @ livebirths for the control group ( RR @ , @-@ , p = @ ) and suspected maternal infection was reported in @ ( @ % ) of @,@ women in the intervention group and @ ( @ % ) of @,@ in the control group ( OR @ , @-@ , p < @ ) .


Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups , neonatal mortality did not decrease in this group , and increased in the population overall .


For every @ women exposed to this strategy , an excess of @ neonatal deaths occurred , and the risk of maternal infection seems to have been increased .


This study investigates the acute and longitudinal effects of resistance training on occupational muscle activity in office workers with chronic pain .


@ female office workers with chronic neck and shoulder pain participated for @ weeks in high-intensity elastic resistance training for @ minutes per day ( n = @ ) or in control receiving weekly email-based information on general health ( n = @ ) .