Oligofructose increased breath hydrogen ( P < @ ) , late acetate concentrations ( P = @ ) , tended to increase total area under the curve ( tAUC ) @ mins peptide YY ( PYY ) ( P = @ ) and reduced tAUC@ mins hunger ( P = @ ) and motivation to eat ( P = @ ) when compared with cellulose .


However , there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide @ ( GLP-@ ) ( P = @ ) in the cellulose group and a decrease in EI during ad libitum meal in both groups .


Oligofructose increased plasma PYY concentrations and suppressed appetite , while cellulose increased GLP-@ concentrations .


EI decreased in both groups .


However , these positive effects did not translate into changes in BW or adiposity .


Triple-negative breast cancer ( TNBC ) patients without pathological complete response ( pCR ) to neoadjuvant chemotherapy have an unfavourable prognosis .


TNBC harbouring BRCA-@ germline mutations may be less responsive to taxanes , while sensitivity to DNA-damaging agents is retained .


A similar effect was seen in tumours with epigenetic BRCA-@ silencing .


Patients without pCR to neoadjuvant chemotherapy consisting of epirubicin plus docetaxel routinely received post-operative CMF at our centre .


Here , we investigated the effect of adjuvant CMF in patients with or without BRCA-@ methylation or TP@ mutation .


DNA was extracted from formalin-fixed paraffin-embedded tissue .


For determining BRCA-@ methylation status , quantitative methylation-specific PCR was performed .


For the investigation of TP@ mutation status , DNA was PCR amplified and sequenced by Sanger sequencing .


Twenty-four patients were included ; BRCA-@ methylation was present in @ % , while TP@ mutations were observed in @ % .


At a median follow-up of @ months , @ % of patients with BRCA-@ methylation had a disease-free survival ( DFS ) event , as compared to @ % in the non-methylated group ( p = @ ) .


Median DFS in the non-methylated group was @ months and was not reached in the methylated group ( n.s. ) .


No association TP@ mutation status with clinical outcome was observed .


Adjuvant CMF is of limited activity in TNBC refractory to taxane-based neoadjuvant chemotherapy .


In this population , BRCA-@ methylation was associated with a significant decrease in DFS events suggesting a better prognosis and potentially retained activity of DNA-damaging agents .


New evidence indicates that increased dietary protein ingestion promotes health and recovery from illness , and also maintains functionality in older adults .


The present study aimed to investigate whether a novel food service concept with protein-supplementation would increase protein and energy intake in hospitalised patients at nutritional risk .


A single-blinded randomised controlled trial was conducted .


Eighty-four participants at nutritional risk , recruited from the departments of Oncology , Orthopaedics and Urology , were included .


The intervention group ( IG ) received the protein-supplemented food service concept .


The control group ( CG ) received the standard hospital menu .


Primary outcome comprised the number of patients achieving @ % of energy and protein requirements .


Secondary outcomes comprised mean energy and protein intake , body weight , handgrip strength and length of hospital stay .


In IG , @ % versus @ % CG patients reached @ % of their energy requirements ( P = @ ) ; @ % IG versus @ % CG patients reached @ % of their protein requirements ( P = @ ) .


The risk ratio for achieving @ % of protein requirements : @ ( @ % confidence interval = @-@ @ ) ; number needed to treat = @ ( @ % confidence interval = @-@ ) .


IG had a higher mean intake of energy and protein when adjusted for body weight ( CG : @kJkg ( -@ ) versus IG : @kJkg ( -@ ) , P = @ ; CG : @ g proteinkg ( -@ ) versus @ g proteinkg ( -@ ) , P = @ ) .


Body weight , handgrip strength and length of hospital stay did not differ between groups .


The novel food service concept had a significant positive impact on overall protein intake and on weight-adjusted energy intake in hospitalised patients at nutritional risk .


To compare the efficacy of different points combination in the treatment of menopausal insomnia .


Ninety-six cases of menopausal insomnia were randomized into @ groups , Xinshu ( BL @ ) , Shenshu ( BL @ ) , Sishencong ( EX-HN @ ) , Shenmen ( HT @ ) , Sanyinjiao ( SP @ ) were chosen in the restore interaction between the heart and the kidney group ( group A , @ cases ) ; Zhaohai ( KI @ ) , Jiaoxin ( KI @ ) , Shenmai ( BL @ ) , Pucan ( BL @ ) were chosen in the acupuncturing qiao mai group ( group B , @ cases ) ; auricular Shenmen ( TF@ ) and sensitive spot at the distribution area of auricular vagus nervus were chosen in the ear acupuncture group ( group C , @ cases ) .


Six days made one session and the treatments were finished after @ courses .


The polysomnography ( PSG ) and Pittsburgh sleep quality index ( PSQI ) were employed before and after treatment to evaluate the alleviation of insomnia .


The parameters of the sleep latency ( SL ) , rapid wave sleep latency ( RL ) and sleep efficiency ( SE ) were significantly improved in the three groups , and the differences were statistically significant ( P < @ , P < @ ) .


The SL and awaking time ( AT ) in group C -LSB- SL ( @ + / - @ ) min and AT ( @ + / - @ ) times -RSB- were significantly superior to those in the other two groups -LSB- SL ( @ + / - @ ) min , ( @ + / - @ ) min , AT ( @ + / - @ ) times , ( @ + / - @ ) times , all P < @ -RSB- .


The S ( @ +@ ) ( % ) in group C was also significantly higher than those in the other two groups ( both P < @ ) .


It was indicated by PSQI that the sleep quality of group C ( @ + / - @ ) was significantly superior to that in group B ( @ + / - @ ) , the total score and cured and markedly effective rate in group C -LSB- ( @ + / - @ ) , @ % ( @/@ ) -RSB- were superior to those in group A -LSB- ( @ + / - @ ) , @ % ( @/@ ) , both P < @ -RSB- .


Ear acupuncture has a better curative effect than the restore interaction between the heart and the kidney group and acupuncturing qiao mai group , it is worth of being promoted .


Latinas with breast cancer suffer symptom and psychosocial health disparities .


Effective interventions have not been developed for or tested in this population .


We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program , a culturally tailored , peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer , and unique considerations in implementing a randomized controlled trial to test the program in community settings .


We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial , emphasizing community engagement processes .


In phase @ , we established project infrastructure : academic and community co-principal investigators , community partners , community advisory board , steering committee , and funding .


In phase @ , we identified three program inputs : formative research , a community best-practices model , and an evidence-based intervention tested in non-Latinas .


In phase @ , we created the new program by integrating and adapting intervention components from the three sources , making adaptations to accommodate low literacy , Spanish language , cultural factors , community context , and population needs .


In phase @ , we built community capacity for the program and trial by training field staff ( recruiters and interventionists embedded in community sites ) , compensating field staff , and creating a system for identifying potential participants .


In phase @ , we implemented and monitored the program and trial .


Engaging community partners in all phases has resulted in a new , culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners .


Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings .


Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation .


Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues .


Randomization was challenging due to community concerns about assigning women to a control group .


Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment .


These were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives .


Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context .


If the randomized trial demonstrates that the intervention is effective , it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer .


Exercise intolerance is a hallmark of chronic obstructive pulmonary disease ( COPD ) .


Patients with COPD were randomized in two multicentre , double-blind , incomplete block crossover studies .


Patients received two of six treatments in sequence ( @ weeks each ) : placebo , umeclidinium ( UMEC ) / vilanterol ( VI ) ( @/@ mcg or @ / @ mcg ) , VI ( @ mcg ) or UMEC ( @ mcg or @ mcg ) .


Exercise endurance time ( EET ) and trough forced expiratory volume in @ second ( FEV@ ) ( Week @ ) were co-primary endpoints .


Safety was monitored throughout .


Both studies showed similar @-hour post-dose EET improvements from baseline for UMEC/VI ( Week @ ) .


Significant EET improvements were observed with both UMEC/VI doses versus placebo at Week @ in Study @ ( UMEC/VI @/@ mcg : @ s ; p = @ ; UMEC/VI @ / @ mcg : @ s ; p = @ ) , but not in Study @ , where a placebo effect was evident .


Post hoc integrated data analysis showed significant but smaller EET improvements for both UMEC/VI doses versus placebo at Week @ ( UMEC/VI @/@mcg : @ s ; p = @ ; UMEC/VI @ / @ mcg : @ s ; p = @ ) .


Both studies showed trough FEV@ improvements at Week @ for both UMEC/VI doses .


The incidence of adverse events was similar between treatment groups within each study .


UMEC/VI improved lung function and EET .


Fear of falling ( FOF ) is commonly experienced in people with Parkinson 's disease ( PD ) .


It is a predictor of recurrent falls , a barrier to physical exercise , and negatively associated with health-related quality of life .


A variety of rating scales exist that assess different aspects of FOF but comprehensive head-to-head comparisons of their psychometric properties in people with PD are lacking .


The aim of this study was to evaluate the psychometric properties of four FOF rating scales in people with PD .


More specifically , we investigated and compared the scales ' data completeness , scaling assumptions , targeting , and reliability .


The FOF rating scales were : the Falls Efficacy Scale-International ( FES-I ) , the Swedish FES ( FES ( S ) ) , the Activities-specific Balance Confidence scale ( ABC ) , and the modified Survey of Activities and Fear of Falling in the Elderly ( mSAFFE ) .


A postal survey was administered to @ persons with PD .


Responders received a second survey after two weeks .


The mean ( SD ) age and PD duration of the @ responders were @ ( @ ) and @ ( @ ) years , respectively .


ABC had worse data completeness than the other scales ( @ vs. @-@ @ % missing data ) .


All scales had corrected item-total correlations exceeding @ and showed acceptable reliabilities ( Cronbach 's alpha and Intraclass Correlation Coefficient ( ICC ) > @ ) but only FES-I had ICC > @ .


The standard error of measurements ranged from @ % ( FES-I ) to @ % ( FES ( S ) ) , and the smallest detectable differences ranged from @ % ( FES-I ) to @ % ( FES ( S ) ) of the total score ranges .


ABC and FES ( S ) had substantially more outliers than mSAFFE and FES-I ( @ and @ vs. @ and @ , respectively ) when the two test occasions were compared .


When assessing FOF in people with PD , the findings in the present study favoured the choice of FES-I or mSAFFE .


However , FES-I was the only scale with ICC > @ which has been suggested as a minimum when using a scale for individual comparisons .


Agreement between client and therapist on treatment goals has been consistently linked with improved treatment outcomes .


Having clear and collaborative goals may be particularly important when working with clients diagnosed with personality disorders who are often difficult to engage and test the boundaries of therapy .


This paper outlines the development of a personality disorder treatment goal checklist aimed at helping clients and therapists to identify and prioritize their goals for therapy .


The checklist was developed using self-reported problems of the first @ participants randomized into the psychoeducation and problem solving ( PEPS ) trial .


Problems were coded and categorized into problem areas .


The checklist was viewed by two service users who gave suggestions for improvements .


The final checklist consists of @ items in @ problem areas .


The checklist may provide a clinically useful tool for working with this client group .


LCn-@PUFA comprised of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) offer cardioprotection involving a decrease in coagulant activity ; however , the evidence is equivocal .


We have previously demonstrated that the acute ( @ h ) effects and chronic ( @ weeks ) effects of LCn-@PUFA supplementation on platelet aggregation in human subjects are sex specific .


This study investigated the mechanisms of the sex-dependent effects of LCn-@PUFA with @ weeks supplementation of EPA-rich vs. DHA-rich oils on procoagulant and platelet activity in healthy subjects .


A double-blinded , placebo-controlled randomised trial was conducted in @ healthy adults : male ( n = @ ) and female ( n = @ ) .


Platelet coagulation parameters including factors I , II , V , VII , VIII , IX , X , vWF : Ag and endogenous thrombin potential were measured at baseline and @ weeks postsupplementation with EPA-rich or DHA-rich oil capsules .


We have previously reported that platelet aggregation is specifically reduced by supplementation with EPA in males and DHA in females .


This sex-specific effect was also observed for decreases in plasma levels of Factor II ( -@ @ % , P = @ ) , Factor V ( -@ @ % , P = @ ) and vWF : Ag ( -@ @ % , P = @ ) and was most pronounced in males supplemented with EPA .


In contrast , DHA-mediated reduction in platelet aggregation in females was not accompanied by any significant changes in the coagulation parameters tested .


Significant interactions between sex and specific LCn-@PUFA exist to reduce procoagulant activity differentially in males vs. females and could have profound effects on managing risk of thrombotic disease .


Over the past decades , the operative treatment of displaced midshaft clavicular fractures has increased .


The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures .


A multicenter , randomized controlled trial was performed in four different hospitals .


The study included @ patients , eighteen to sixty-five years of age , treated with either open reduction and plate fixation ( n = @ ) or intramedullary nailing ( n = @ ) .


Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively .


Significance was set at p < @ .


No significant differences in the Disabilities of the Arm , Shoulder and Hand ( DASH ) or Constant-Murley score ( @ and @ points for the plate group and @ and @ points for the nailing group ) were noted between the two surgical interventions at six months postoperatively .


Until six months after the surgery , the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period ( p = @ ) .


The mean numbers of complications per patient , irrespective of their severity , were similar between the plate-fixation ( @ ) and nailing ( @ ) groups ( p = @ ) .


The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group , but the groups had similar results at six months postoperatively and the time of final follow-up .


The rate of complications requiring revision surgery was low .


Implant-related complications occurred frequently and could often be treated by implant removal .


To evaluate the effect of formulation and a high-fat meal on the pharmacokinetics of orally administered lenvatinib ( E@ ) .


Lenvatinib @-mg capsule and tablet .


Pharmacokinetics and safety of a single @-mg lenvatinib dose were evaluated in healthy subjects in two randomized , two-period , crossover , phase @ , bioavailability trials .


The first compared a new capsule formulation with an older tablet formulation ( n = @ subjects ) ; the second evaluated the influence of a standard high-fat meal on the relative bioavailability of the capsule formulation ( n = @ subjects ) .


Geometric least squares mean ratios of AUC@ - , maximum observed concentration ( Cmax ) , and AUC@-t were determined .


tmax , tlag ( food effect only ) , and t@/@ , z were also calculated , and descriptive statistics were provided .


A total of @ healthy volunteers were enrolled in the two studies ( mean ages @ and @ years ) .


In the formulation study , AUC@ - and AUC@-t of the capsule formulation were ~ @ % less than the tablet formulation , and Cmax for the capsule formulation was ~ @ % lower .


@ % Confidence intervals ( CIs ) for both AUCs were within the @ - @ % CI , which is generally considered to denote bioequivalence , while the lower bound of the interval for Cmax was @ % .


tmax and t@/@ , z were comparable .


For the capsule formulation , the mean ( % CV ) t@/@ , z was @ hours ( @ ) and the median ( range ) tmax was @ hours ( @ - @ ) .


In the food effect study , lenvatinib 's AUC@ - and AUC@-t increased ~ @ % and @ % with the high-fat meal .


Cmax following a high-fat meal was @ % lower than following administration in the fasted state .


Administration with food delayed lenvatinib 's tmax ( @ vs. @ hours ) .


@ % CIs for AUCs were within the @ - @ % CI , while the CI for Cmax was @ - @ % .


The single @-mg dose demonstrated an acceptable tolerability profile ; treatment-emergent adverse events occurred in @ subjects ( @ % ) overall and were typically mild in severity .


These studies show that a new capsule formulation produces slightly lower exposure ( ~ @ - @ % ) to lenvatinib compared with the original tablet formulation , and that oral administration with a high-fat meal does not significantly affect exposure , although absorption is delayed .


Thus , lenvatinib can be administered without regard to the timing of meals .


To study the clinical effectiveness and safety of nasal intermittent positive pressure ventilation ( NIPPV ) in the initial treatment of neonatal respiratory distress syndrome ( NRDS ) and the initial setting of NIPPV parameters .


One hundred neonates with NRDS were divided into NIPPV group ( n = @ ) and nasal continuous positive airway pressure ( NCPAP ) group ( n = @ ) .


A randomized controlled study was conducted to compare the effectiveness of NIPPV versus NCPAP in the initial treatment of NRDS from the following aspects : reducing CO@ retention , improving oxygenation , reducing second endotracheal intubation and second use of pulmonary surfactant ( PS ) , reducing the duration of invasive respiratory support , reducing the duration of oxygen use , and reducing the incidence of air leak , abdominal distension and ventilator-associated pneumonia .


After @ and @ hours of noninvasive respiratory support , the NIPPV group was superior to the NCPAP group with respect to the reduction in CO@ retention and improvement in oxygenation ( P < @ ) ; in addition , compared with the NCPAP group , the NIPPV group had significantly lower rates of second endotracheal intubation and second PS use , significantly shorter duration of invasive respiratory support and time of FiO@ > @ , and significantly lower incidence of apnea and ventilator-associated pneumonia ( P < @ ) ; there were no significant differences in the incidence of air leak and abdominal distention between the two groups .


NIPPV is effective and safe in the initial treatment of NRDS and holds promise for clinical application .


Patients are increasingly being admitted with chronic atrial fibrillation , and disease-specific management might reduce recurrent admissions and prolong survival .


However , evidence is scant to support the application of this therapeutic approach .


We aimed to assess SAFETY -- a management strategy that is specific to atrial fibrillation .


We did a pragmatic , multicentre , randomised controlled trial in patients admitted with chronic , non-valvular atrial fibrillation ( but not heart failure ) .


Patients were recruited from three tertiary referral hospitals in Australia .


@ participants were randomly assigned by computer-generated schedule ( stratified for rhythm or rate control ) to either standard management ( n = @ ) or the SAFETY intervention ( n = @ ) .


Standard management consisted of routine primary care and hospital outpatient follow-up .


The SAFETY intervention comprised a home visit and Holter monitoring @-@ days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed .


Clinical reviews were undertaken at @ and @ months ( minimum follow-up ) .


Coprimary outcomes were death or unplanned readmission ( both all-cause ) , measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital .


Analyses were done on an intention-to-treat basis .


The trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTRN @ ) .


During median follow-up of @ days ( IQR @-@ ) , @ people died and @ unplanned admissions were recorded ( totalling @ days in hospital ) .


@ ( @ % ) patients assigned to the SAFETY intervention died or had an unplanned readmission ( median event-free survival @ days -LSB- IQR @-@ -RSB- ) and @ ( @ % ) people allocated standard management achieved a coprimary outcome ( @ days -LSB- @-@ -RSB- ; hazard ratio @ , @ % CI @-@ ; p = @ ) .


Patients assigned to the SAFETY intervention had @ % maximum event-free days ( @ % CI @-@ ) , equating to a median of @ ( IQR @-@ ) of @ maximum days alive and out of hospital .


By comparison , those allocated to standard management had @ % ( @ % CI @-@ ) maximum event-free days , equating to a median of @ ( IQR @-@ ) of @ maximum days alive and out of hospital ( effect size @ , @ % CI @-@ ; p = @ ) .


A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital ( but not prolonged event-free survival ) relative to standard management .


Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation .


To examine the effects of using vinyl isolation bags or polyethylene wrap for the prevention of postnatal hypothermia in preterm infants at @ weeks gestation .


A prospective , randomized controlled trial .


The neonatal intensive care unit ( NICU ) of the Istanbul Faculty of Medicine in Turkey .


Fifty-nine preterm infants .


Participants were randomly assigned to either the vinyl isolation-bag experimental group ( n = @ ) or the polyethylene-wrap control group ( n = @ ) .


Infant body temperature was measured at four time points after birth .


Loss of body temperature was significantly less in the vinyl isolation-bag group during the first @ minutes after birth ( p = @ ) .


Body temperature decreased by @ @ C in the vinyl isolation-bag group and @ @ C in the polyethylene wrap group .


Body temperature was significantly less in the polyethylene wrap group compared to the vinyl isolation-bag group at birth to @ minutes ( p = @ ) .


Wrapping preterm infants of gestational age @ weeks in vinyl bags immediately after birth is associated with lower incidences of hypothermia .


Previous studies have suggested the potential importance of three DPYD variants ( DPYD * @A , D@V , and I@S ) with increased @-FU toxicity .


Their individual associations , however , in @-FU-based combination therapies , remain controversial and require further systematic study in a large patient population receiving comparable treatment regimens with uniform clinical data .


We genotyped @ stage III colon cancer patients treated adjuvantly in a randomized phase III trial with FOLFOX or FOLFIRI , alone or combined with cetuximab , and tested the individual associations between functionally deleterious DPYD variants and toxicity .


Logistic regressions were used to assess univariate and multivariable associations .


All statistical tests were two-sided .


In @ patients with complete adverse event ( AE ) data , the incidence of grade @ or greater @FU-AEs in DPYD * @A , I@S , and D@V carriers were @/@ ( @ % ) , @/@ ( @ % ) , and @/@ ( @ % ) , respectively .


Statistically significant associations were identified between grade @ or greater @FU-AEs and both DPYD * @A ( odds ratio -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @ to @ , P < @ ) and D@V ( OR = @ , @ % CI = @ to @ , P < @ ) variants .


Statistical significance remained after adjusting for multiple variables .


The DPYD * @A variant statistically significantly associated with the specific AEs nausea/vomiting ( P = @ ) and neutropenia ( P < @ ) , whereas D@V statistically significantly associated with dehydration ( P = @ ) , diarrhea ( P = @ ) , leukopenia ( P = @ ) , neutropenia ( P < @ ) , and thrombocytopenia ( P < @ ) .


Although two patients with I@S had grade@ @FU-AEs ; a statistically significant association could not be demonstrated because of its low frequency ( P = @ ) .


In the largest study to date , statistically significant associations were found between DPYD variants ( DPYD * @A and D@V ) and increased incidence of grade @ or greater @FU-AEs in patients treated with adjuvant @-FU-based combination chemotherapy .


To compare structural knee joint changes in obese patients with knee osteoarthritis ( OA ) that after an intensive weight loss therapy were randomized to continuous dietetic support , a specialized knee exercise program , or ` no attention ' for @ year .


@ obese individuals with knee OA underwent an intensive @-week weight loss program with subsequent randomization to one of the three treatment groups .


Changes in cartilage loss , bone marrow lesions ( BMLs ) , synovitis , and effusion were assessed using semi quantitative assessments of magnetic resonance imaging ( MRI ) obtained at weeks @ and @ applying the BLOKS score .


During the @ weeks maintenance period the continuous dietary maintenance group support on average gained @ kg ( @ % CI : -@:@ ) body mass , the exercise group gained @ kg ( @ % CI @:@ ) and the no-attention group gained @ kg ( @ % CI : @:@ ) .


There were no statistically significant between-group differences in changes in cartilage loss , synovitis or effusion at the follow-up ( analysis of covariance ; ANCOVA , P > @ ) , while there was an increased number of medial tibiofemoral BMLs in the exercise group ( ANCOVA , P = @ ) compared to both diet ( difference : -@ -LSB- @ % CI -@ : -@ -RSB- ) and `` no attention '' ( difference : -@ -LSB- @ % CI -@ : -@ -RSB- ) groups .


In this @ year follow-up after weight-loss in obese knee OA patients , we found a potentially increased number of BMLs in the exercise group compared to the diet and no attention groups , with no between-group differences in changes in cartilage loss , synovitis or effusion .


These findings should be interpreted with caution for exercise compliance , MRI methodology and follow-up time .


( ClinicalTrials.gov identifier : NCT@ ) .


Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than @ million young children worldwide who are not meeting their developmental potential .


We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker ( LHW ) programme in Sindh , Pakistan .


We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh , Pakistan , with a @ factorial design .


We randomly allocated @ clusters ( LHW catchments ) of children to receive routine health and nutrition services ( controls ; n = @ ) , nutrition education and multiple micronutrient powders ( enhanced nutrition ; n = @ ) , responsive stimulation ( responsive stimulation ; n = @ ) , or a combination of both enriched interventions ( n = @ ) .


The allocation ratio was @:@ ( ie , @ clusters per intervention group ) .


The data collection team were masked to the allocated intervention .


All children born in the study area between April , @ , and March , @ , were eligible for enrolment if they were up to @ months old without signs of severe impairments .


Interventions were delivered by LHWs to families with children up to @ months of age in routine monthly group sessions and home visits .


The primary endpoints were child development at @ and @ months of age ( assessed with the Bayley Scales of Infant and Toddler Development , Third Edition ) and growth at @ months of age .


Analysis was by intention to treat .


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


@ mother-infant dyads were enrolled into the study , of whom @ ( @ % ) were followed up until the children were @ months old .


Children who received responsive stimulation had significantly higher development scores on the cognitive , language , and motor scales at @ and @ months of age , and on the social-emotional scale at @ months of age , than did those who did not receive the intervention .


Children who received enhanced nutrition had significantly higher development scores on the cognitive , language , and social-emotional scales at @ months of age than those who did not receive this intervention , but at @ months of age only the language scores remained significantly higher .


We did not record any additive benefits when responsive stimulation was combined with nutrition interventions .


Responsive stimulation effect sizes ( Cohen 's d ) were @ for cognition , @ for language , and @ for motor development at @ months of age ; these effect sizes were slightly smaller for the combined intervention group and were low to moderate for the enhanced nutrition intervention alone .


Children exposed to enhanced nutrition had significantly better height-for-age Z scores at @ months ( p < @ ) and @ months ( p = @ ) than did children not exposed to enhanced nutrition .


Longitudinal analysis showed a small benefit to linear growth from enrolment to @ months ( p = @ ) in the children who received the enhanced nutrition intervention .


The responsive stimulation intervention can be delivered effectively by LHWs and positively affects development outcomes .


The absence of a major effect of the enhanced nutrition intervention on growth shows the need for further analysis of mediating variables ( eg , household food security status ) that will help to optimise future nutrition implementation design .


Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists .


We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy .


We did this randomised , double-blind , placebo-controlled trial between Dec @ , @ , and Oct @ , @ , at @ academic sites specialised in the care of patients with multiple systemic atrophy across @ countries .


Eligible participants aged @ years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned ( @:@ ) , via computer-generated block randomisation ( block size of four ) , to receive either rasagiline @ mg per day or placebo .


Randomisation was stratified by study centre .


The investigators , study funder , and personnel involved in patient assessment , monitoring , analysis and data management were masked to group assignment .


The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale ( UMSARS ) score ( parts I and II ) .


Analysis was by modified intention to treat .


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


We randomly assigned @ participants to the rasagiline group ( n = @ ) or the placebo group ( n = @ ) ; @ ( @ % ) patients in the rasagiline group and @ ( @ % ) in the placebo group withdrew from the study early .


At week @ , patients in the rasagiline group had progressed by an adjusted mean of @ ( SE @ ) total UMSARS units versus @ ( @ ) units in those in the placebo group .


This treatment difference of -@ ( @ % CI -@ to @ ; p = @ ) was not significant .


@ ( @ % ) patients in the rasagiline group and @ ( @ % ) patients in the placebo group reported adverse events , and we recorded serious adverse events in @ ( @ % ) versus @ ( @ % ) patients .


The most common adverse events in the rasagiline group were dizziness ( n = @ -LSB- @ % -RSB- ) , peripheral oedema ( n = @ -LSB- @ % -RSB- ) , urinary tract infections ( n = @ -LSB- @ % -RSB- ) , and orthostatic hypotension ( n = @ -LSB- @ % -RSB- ) .


In this population of patients with the parkinsonian variant of multiple system atrophy , treatment with rasagiline @ mg per day did not show a significant benefit as assessed by UMSARS .


The study confirms the sensitivity of clinical outcomes for multiple system atrophy to detect clinically significant decline , even in individuals with early disease .


Ultravision is a new device that utilizes electrostatic precipitation to clear surgical smoke .


The aim was to evaluate its performance during laparoscopic cholecystectomy .


Patients undergoing laparoscopic cholecystectomy were randomized into `` active ( device on ) '' or `` control ( device off ) . ''


Three operating surgeons scored the percentage effective visibility and three reviewers scored the percentage of the procedure where smoke was present .


All assessors also used a @-point scale ( @ = imperceptible/excellent and @ = very annoying/bad ) to rate visual impairment .


Secondary outcomes were the number of smoke-related pauses , camera cleaning , and pneumoperitoneum reductions .


Mean results are presented with @ % confidence intervals ( CI ) .


In @ patients ( active @ , control @ ) , the effective visibility was @ % ( @-@ @ ) for active cases and @ % ( @-@ @ ) for controls .


The proportion of the procedure where smoke was present was @ % ( @-@ @ ) for active cases and @ % ( @-@ @ ) for controls .


Operating surgeons rated the visual impairment as @ ( @-@ @ ) for active cases and @ ( @-@ @ ) for controls .


Reviewers rated the visual impairment as @ ( @-@ @ ) for active cases and @ ( @-@ @ ) for controls .


In the active group , @ % of procedures were paused to allow smoke clearance compared to @ % of control cases .


Camera cleaning was not needed in @ % of active procedures and @ % of controls .


The pneumoperitoneum was reduced in @ % of active cases and @ % of controls .


Ultravision improves visibility during laparoscopic surgery and reduces delays in surgery for smoke clearance and camera cleaning .


Propofol injection pain , despite various strategies , remains common and troublesome .


This study aimed to test the hypothesis that pretreatment with the combination of intravenous lidocaine and magnesium would have an additive effect on reducing propofol injection pain .


After institutional review board ( IRB ) approval and informed consent , we performed a prospective , double-blind , placebo-controlled , randomized trial .


Subjects were randomly assigned to pretreatment with either lidocaine ( @mg ) , magnesium sulfate ( @ mg ) , lidocaine ( @mg ) plus magnesium sulfate ( @ mg ) , or @ % sodium chloride .


Following pretreatment , propofol ( @mg ) was administered , and subjects were questioned regarding injection site pain and observed for behavioral signs of pain .


Two hundred subjects were enrolled and @ subjects ( @ placebo , @ lidocaine , @ magnesium sulfate , and @ lidocaine plus magnesium sulfate ) received their assigned pretreatment intervention .


Intergroup baseline characteristics were similar .


The proportion of subjects reporting propofol injection pain was highest in those pretreated with magnesium sulfate ( @ % ) , followed by those pretreated with placebo ( @ % ) , lidocaine plus magnesium sulfate ( @ % ) , and then lidocaine ( @ % ; p = @ ) .


When adjusted for age , gender , diabetes mellitus , chronic pain , tobacco use , and selective-serotonin reuptake inhibitor use , the pain response scale scores were significantly reduced by lidocaine pretreatment compared to magnesium sulfate and placebo ( p = @ and p = @ , respectively ) .


In this double-blind , placebo-controlled , randomized trial , the combination of intravenous magnesium sulfate and lidocaine offered no additional benefit for the relief of propofol injection pain compared to intravenous lidocaine alone .


An improved , receptor-based understanding of the mechanism of propofol injection pain is still needed .


This study was designed to evaluate the outcomes of alcohol septal ablation ( ASA ) under multicenter and multinational conditions .


Data for @ patients ( age @ years ) from nine European centers were prospectively collected and retrospectively analyzed .


ASA led to a significant reduction in outflow gradient ( PG ) and dyspnea -LSB- median of PG from @ ( @-@ ) mm Hg to @ ( @-@ ) mm Hg ; median of NYHA class from @ ( @-@ ) to @ ( @-@ ) ; P < @ -RSB- .


The incidence of @-month major adverse events ( death , electrical cardioversion for tachyarrhythmias , resuscitation ) and mortality was @ % and @ % , respectively .


Permanent pacemakers for post-ASA complete heart block were implanted in @ patients ( @ % ) .


Multivariate analysis identified higher amount of alcohol ( however , in generally low-dose procedures ) , higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease @ % .


The results of the first European multicenter and multinational study demonstrate that real-world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction .


Inability to read instructions on drug labels has been identified among the Malaysian population since @ 's .


To assess the impact of font-enlarged and pictogram-incorporated labels used for long-term medications on patients ' adherence , comprehension and preferences .


Outpatient pharmacy in one of the major general hospitals across Northern Malaysia .


This was a three-arm , randomized controlled trial .


Outpatients with refill prescriptions of selected oral antihypertensive or antidiabetic medications were screened for eligibility .


They were randomly allocated with standard ( n = @ ) , font-enlarged ( n = @ ) or pictogram-incorporated ( n = @ ) labels .


Assessment of baseline adherence scores using the @-item Morisky Medication Adherence Scale , comprehension scores using a structured questionnaire and preferences was conducted upon recruitment .


Follow-up telephone interviews were conducted after @ weeks .


The changes of patients ' adherence and comprehension scores and their preferences .


Within-group comparisons demonstrated an increase of total adherence scores after @ weeks in all three groups ( mean changes @ , @ and @ ; p = @ , @ and @ , respectively ) .


The repeatedly measured total comprehension score of pictogram-incorporated label group was significantly higher than baseline ( mean change @ , p = @ ) .


Two intervention groups obtained significantly higher scores for few items in both adherence and comprehension measurements after @ weeks as compared with baselines .


As indicated by F tests , three groups did not significantly differ in the changes of both total adherence and comprehension scores ( p = @ and @ , respectively ) with the subjects ' age adjusted .


Elderlies and those with a higher number of morbidity preferred pictogram-incorporated label over font-enlarged label .


We did not find a significant change of both adherence and comprehension levels after the introduction of modified medication labels .


However , on the basis of within-group comparisons , they may have positive influences on certain aspects of patients ' adherence and comprehension .


Variations in preferences may reflect the unique need of different subgroups in receiving written medication instructions .


The purpose of this article is to evaluate the efficacy of IV hyoscine butylbromide as a bowel relaxant and automated carbon dioxide insufflation in CT colonography in terms of colonic distention and perceived burden .


SUBJECTS AND METHODS ; Two hundred twenty-four participants were randomly allocated to one of four groups : control ( no bowel relaxant and IV saline placebo before CT colonography with manual carbon dioxide insufflation ) , hyoscine butylbromide ( IV hyoscine butylbromide before examination with manual carbon dioxide insufflation ) , automated ( no bowel relaxant before examination with automated carbon dioxide insufflation ) , and combined ( hyoscine butylbromide before examination with automated carbon dioxide insufflation ) .


The degree of colonic distention on a @-point scale , examination time , and participants ' satisfaction , as measured by their responses to a questionnaire , were assessed .


The mean distention grades of all the colonic segments and both positions were @ in the control group , @ in the hyoscine butylbromide group , @ in the automated group , and @ in the combined group .


Compared with manual carbon dioxide insufflation , automated carbon dioxide insufflation significantly improved the clinical adequacy of colonic distention and shortened examination time .


No statistically significant difference was seen in the clinical adequacy of distention between participants who received hyoscine butylbromide and those who did not , or in examination time .


Overall , the participants ' experiences were not different .


Colonic distention was statistically significantly improved by automated carbon dioxide insufflation , but not by the administration of hyoscine butylbromide .


The participants ' tolerance was similar in each group .


Patients with mixed hyperlipidemia usually are in need of combination therapy to achieve low-density lipoprotein cholesterol ( LDL-C ) and triglyceride ( TG ) target values for reduction of cardiovascular risk .


This study investigated the efficacy and safety of adding a new hypolipidemic agent , coenzyme A ( CoA ) to stable statin therapy in patients with mixed hyperlipidemia .


In this multi-center , @-week , double-blind study , adults who had received @ weeks of stable statin therapy and had hypertriglyceridemia ( TG level at @-@ @ mmol/L ) were randomized to receive CoA @ U/d or placebo plus stable dosage of statin .


Efficacy was assessed by the changes in the levels and patterns of lipoproteins .


Tolerability was assessed by the incidence and severity of adverse events ( AEs ) .


A total of @ patients with mixed hyperlipidemia were randomized to receive CoA @ U/d plus statin or placebo plus statin ( n = @ , each group ) .


After treatment for @ weeks , the mean percent change in TG was significantly greater with CoA plus statin compared with placebo plus statin ( -@ % vs -@ % , respectively ; p = @ ) .


CoA plus statin was associated with significant reductions in TC ( -@ % vs -@ % ; p = @ ) , LDL-C ( -@ % vs @ % ; p = @ ) , and non - high-density lipoprotein cholesterol ( -@ % vs -@ % ; p = @ ) .


There was no significant difference in the frequency of AEs between groups .


No serious AEs were considered treatment related .


In these adult patients with persistent hypertriglyceridemia , CoA plus statin therapy improved TG and other lipoprotein parameters to a greater extent than statin alone and has no obviously adverse effect .


The interferon-free regimen of ABT-@ ( a protease inhibitor ) , ritonavir , ombitasvir ( an NS@A inhibitor ) , dasabuvir ( a non-nucleoside polymerase inhibitor ) , and ribavirin has shown efficacy in patients with hepatitis C virus ( HCV ) genotype @b infection-the most prevalent subgenotype worldwide .


We evaluated whether ribavirin is necessary for ABT-@ , ritonavir , ombitasvir , and dasabuvir to produce high rates of sustained virologic response ( SVR ) in these patients .


We performed a multicenter , open-label , phase @ trial of @ patients with HCV genotype @b infection , without cirrhosis , previously treated with peginterferon and ribavirin .


Patients were assigned randomly ( @:@ ) to groups given ABT-@ , ritonavir , ombitasvir , and dasabuvir , with ribavirin ( group @ ) or without ( group @ ) for @ weeks .


The primary end point was SVR @ weeks after treatment ( SVR@ ) .


We assessed the noninferiority of this regimen to the rate of response reported ( @ % ) for a similar population treated with telaprevir , peginterferon , and ribavirin .


Groups @ and @ each had high rates of SVR@ , which were noninferior to the reported rate of response to the combination of telaprevir , peginterferon , and ribavirin ( group @ : @ % ; @ % confidence interval , @ % -@ % ; and group @ : @ % ; @ % confidence interval , @ % -@ % ) .


The rate of response in group @ was noninferior to that of group @ .


No virologic failure occurred during the study .


Two patients ( @ % ) discontinued the study owing to adverse events , both in group @ .


The most common adverse events in groups @ and @ were fatigue ( @ % vs @ % ) and headache ( @ % vs @ % ) , respectively .


Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group @ ( @ % vs @ % in group @ ; P < @ ) , although only @ patients had hemoglobin levels less than @ g/dL .


The interferon-free regimen of ABT-@ , ritonavir , ombitasvir , and dasabuvir , with or without ribavirin , produces a high rate of SVR@ in treatment-experienced patients with HCV genotype @b infection .


Both regimens are well tolerated , as shown by the low rate of discontinuations and generally mild adverse events .


ClinicalTrials.gov number : NCT@ .


This study compared the efficacy of risperidone monotherapy with risperidone plus valproate in bipolar I disorder , manic phase .


Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder , so we examined this effectiveness in this clinical-trial study .


This @-week , randomized , single-blind study included @ bipolar I inpatients manic phase without psychotic features divided in risperidone group ( n = @ ) and risperidone plus sodium valproate group ( n = @ ) .


According to clinical symptoms , @ categories : complete remission , partial remission and no remission were mentioned in weekly follow-up .


Remission rate compared with survival analysis .


The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the @st , @nd and the @rd week ( p = @ , @ , @ respectively ) , It means the remission rate in risperidone plus valproate group was higher in the first three weeks , but at the end of the seventh week , the difference was not statistically significant .


There was no significant difference between the two groups in the development of adverse effects .


Risperidone can be effective and well tolerated in both acute manic episodes of bipolar mood disorders .


Mediastinitis costs hospitals thousands of dollars a year and increases the incidence of patient morbidity and mortality .


No studies have been done to evaluate adenosine triphosphate ( ATP ) counts on disposable and nondisposable electrocardiography ( ECG ) lead wires in pediatric patients .


To compare the cleanliness of disposable and nondisposable ECG lead wires in postoperative pediatric cardiac surgery patients by measuring the quantity of ATP ( in relative luminescence units -LSB- RLUs -RSB- ) .


ATP levels correlate with microbial cell counts and are used by institutions to assess hospital equipment and cleanliness .


A prospective , randomized trial was initiated with approval from the institutional review board .


Verbal consent was obtained from the parents/guardians for each patient .


Trained nurses performed ATP swabs on the right and left upper ECG cables on postoperative days @ , @ , and @ .


This study enrolled @ patients .


The disposable ECG lead wire ATP count on postoperative day @ ( median , @ RLUs ) was significantly lower ( P < @ ) than the count for nondisposable ATP lead wires ( median , @ RLUs ) .


On postoperative day @ , the ATP count for the disposable ECG lead wires ( median , @ RLUs ) was also lower ( P = @ ) than the count for the nondisposable ECG lead wires ( median , @ RLUs ) .


Results of this study support the use of disposable ECG lead wires in postoperative pediatric cardiac surgery patients for at least the first @ hours as a direct strategy to reduce the ATP counts on ECG lead wires .


Ripasudil hydrochloride hydrate ( K-@ ) , a novel rho kinase inhibitor , provides statistically significant intraocular pressure ( IOP ) - lowering effects and has a tolerable safety profile .


However , no studies have evaluated ripasudil combined with - blockers and prostaglandin analogues .


To evaluate the additive IOP-lowering effects and the safety of ripasudil , @ % , combined with timolol , @ % , or latanoprost , @ % , in patients with primary open-angle glaucoma or ocular hypertension .


We conducted @ , multicenter , randomized , double-masked , parallel group comparison studies of ripasudil-timolol and ripasudil-latanoprost in @ and @ Japanese clinical centers , respectively .


Analyses were performed on an intention-treat-treat basis .


After appropriate run-in periods with timolol or latanoprost , @ and @ patients whose IOP levels were @ mm Hg or higher were enrolled in the ripasudil-timolol and ripasudil-latanoprost groups , respectively .


Enrollment began December @ , @ , and follow-up was completed on September @ , @ , in the ripasudil-timolol study .


Enrollment began December @ , @ , and follow-up was completed on September @ , @ , in the ripasudil-latanoprost study .


Patients were subdivided into @ groups in each study and were treated with ripasudil or placebo twice daily for @ weeks .


The IOP reductions in the ripasudil and placebo groups were analyzed with a repeated-measures analysis of variance model at weeks @ , @ , and @ , at trough ( before instillation -LSB- @ am -RSB- ) and peak ( @ hours after instillation -LSB- @ am -RSB- ) levels .


In the ripasudil-timolol study , the mean IOP reductions from baseline in the ripasudil and placebo groups were -@ and -@ mm Hg at @ am for a difference of @ mm Hg ( @ % CI , @-@ @ mm Hg ; P < @ ) and -@ and -@ mm Hg at @ am for a difference of @ mm Hg ( @ % CI , @-@ @ mm Hg ; P < @ ) , respectively .


In the ripasudil-latanoprost study , those IOP reductions were -@ and -@ mm Hg at @ am for a difference of @ mm Hg ( @ % CI , -@ to @ mm Hg ; P = @ ) and -@ and -@ mm Hg at @ am for a difference of @ mm Hg ( @ % CI , @-@ @ mm Hg ; P < @ ) , respectively .


The most frequently reported adverse event was conjunctival hyperemia , which was mild and in most cases resolved without treatment before the next instillation .


These clinical trials found additive IOP-lowering effects of ripasudil from placebo at trough and peak levels in combination with timolol and at peak level in combination with latanoprost .


However , a definitive difference in the addition of placebo to latanoprost was not identified in the trough level .


Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic ( PK ) and pharmacodynamic ( PD ) profiles of new insulin glargine @U/ml ( Gla-@ ) and insulin glargine @U/ml ( Gla-@ ) in people with type @ diabetes mellitus .


In two double-blind , randomized , crossover studies , @ Japanese participants ( aged @-@years ) and @ European participants ( aged @-@years ) with glycated haemoglobin levels @ % ( @mmol/mol ) received single subcutaneous doses of Gla-@ , @ , @ and @ U/kg ( @ U/kg in the European study only ) , and Gla-@ , @ U/kg .


A @-h euglycaemic clamp procedure was performed after each dosing .


The serum insulin glargine concentration ( INS ) and glucose infusion rate ( GIR ) developed more gradually into more constant and prolonged profiles with Gla-@ than with Gla-@ .


In support of this , the times to @ % of glargine exposure and insulin activity were longer for all Gla-@ doses than for Gla-@ during the @-h clamp period , indicating a more evenly distributed exposure and metabolic effect beyond @h .


Exposure to insulin glargine and glucose utilization were lower with the @ and @ U/ml Gla-@ doses in both studies compared with the @ U/ml Gla-@ dose .


Glucose-lowering activity was detected for up to @h with all doses of Gla-@ .


Single-dose injections of Gla-@ present more constant and prolonged PK and PD profiles compared with Gla-@ , maintaining blood glucose control for up to @h in euglycaemic clamp settings in Japanese and European participants with type @ diabetes .


To investigate whether methotrexate ( MTX ) use , as compared to other therapies , and erythrocyte methotrexate polyglutamate ( MTXGlu ) concentrations are associated with changes in glycosylated hemoglobin ( HbA@c ) levels in rheumatoid arthritis ( RA ) patients .


The derivation cohort consisted of patients selected from the Treatment in the Rotterdam Early Arthritis Cohort who fulfilled the @ American College of Rheumatology/European League Against Rheumatism classification criteria for RA .


Patients were randomized to @ treatment arms : triple disease-modifying antirheumatic drug ( DMARD ) therapy ( consisting of MTX , sulfasalazine , and hydroxychloroquine -LSB- HCQ -RSB- ) + intramuscular ( IM ) glucocorticoids , triple DMARD therapy + oral glucocorticoids , MTX + oral glucocorticoid therapy , MTX therapy , oral glucocorticoid therapy , and HCQ therapy .


HbA@c levels were determined at baseline and at @ months .


Concentrations of erythrocyte MTXGlu@-@ were measured after @ months of treatment .


Within treatment arms , changes in the level of HbA@c were compared by paired t-test .


Associations of MTXGlu concentrations with changes in the level of HbA@c were tested using multiple linear regression analysis , adjusted for age , sex , body mass index , and comedication .


Significant associations were validated using data on RA patients taking MTX who were enrolled in the Methotrexate in Rotterdam cohort .


In the derivation cohort , the mean change in HbA@c level after @ months of treatment was -@ mmoles/mole ( -@ % ) ( P = @ ) .


Levels of HbA@c decreased in @ of the individual treatment groups , as follows : for the triple DMARD therapy + IM glucocorticoids treatment arm , -@ mmoles/mole ( -@ % ) ( P < @ ) , for the triple DMARD therapy + oral glucocorticoids treatment arm , -@ mmoles/mole ( -@ % ) ( P < @ ) , for the MTX treatment arm , -@ mmoles/mole ( -@ % ) ( P = @ ) , and for the HCQ treatment arm , -@ mmoles/mole ( -@ % ) ( P = @ ) .


Increased levels of MTXGlu@ ( = -@ , P = @ ) , MTXGlu@ ( = -@ , P < @ ) , MTXGlu@ ( = -@ , P < @ ) after treatment , MTXGlu@ ( = -@ , P < @ ) , and total MTXGlu ( = -@ , P < @ ) were associated with decreased levels of HBA@c .


In the validation cohort , levels of HbA@c were decreased by @ mmoles/mole ( @ % ) ( P < @ ) after treatment , and MTXGlu@ was associated with decreased levels of HbA@c ( = -@ , P = @ ) .


MTX use and higher concentrations of erythrocyte MTXGlu are associated with decreased levels of HbA@c in RA patients .


Triple DMARD therapy and HCQ treatment resulted in reduced HbA@c levels , and glucocorticoid treatment resulted in increased levels of HbA@c .


To evaluate the accuracy of sonographic classification of chorionicity in a large cohort of twins and investigate which factors may be associated with sonographic accuracy .


We conducted a secondary analysis of a randomized trial of preterm birth prevention in twins .


Sonographic classification of chorionicity was compared with pathologic examination of the placenta .


Maternal ( age , body mass index , diabetes , and hypertension ) , obstetric ( prior cesarean delivery , gestational age at the first sonographic examination , and antepartum bleeding ) , and sonographic ( oligohydramnios , polyhydramnios , and twin-twin transfusion syndrome ) factors were assessed for their possible association with accuracy .


A total of @ twin sets in which chorionicity was classified by sonography before @ weeks ' gestation were included ; @ were dichorionic and @ were monochorionic based on pathologic examination .


Sonography misclassified @ of @ twin pregnancies ( @ % ) : @ of @ dichorionic twins ( @ % ) and @ of @ monochorionic twins ( @ % ) .


The sensitivity and specificity of sonographic diagnosis of monochorionicity were @ % and @ % , respectively .


In a multivariable analysis , pregnancies with initial sonographic examinations before @ weeks ' gestation were less likely to have misclassified chorionicity than those with sonographic examinations at @ to @ weeks ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


For each week increase in gestational age , the odds of misclassification rose by @ % ( OR , @ ; @ % CI , @-@ @ ) .


In the multivariable analysis , maternal age , body mass index , parity , and prior cesarean delivery were not associated with sonographic accuracy .


Sonography before @ weeks incorrectly classified chorionicity in @ % of twin gestations .


Those with first sonographic examinations performed at earlier gestational ages had improved chorionicity diagnosis .


The purpose of this study was to investigate and validate adaptation of a cardiovascular CT angiography contrast injection protocol for lower tube potential .


Eighty-three patients evaluated for thoracic aortic disease with a @-MDCT scanner were imaged at @ kV ( group @ ) or @ kV ( group @ ) with the same contrast protocol ( @ mL iopromide @ mg I/mL at @ mL/s ) .


A pharmacokinetic model was validated and used to simulate aortic attenuation in group @ patients with @ % , @ % , and @ % reduction in contrast volume .


A @ % volume reduction was applied to @ additional patients who underwent imaging at @ kV ( group @ ) .


Patient characteristics , scanning and radiation parameters , and objective and subjective image indexes were compared among groups .


Group @ patients had higher mean aortic blood attenuation ( @ HU ) than group @ patients ( @ HU ) ( p < @ ) but similar image noise .


Group @ and group @ patients had similar mean aortic attenuation and noise .


Subjective assessment of image quality indicated that group @ and group @ had comparable percentages of images with good or excellent diagnostic confidence scores ( reader @ , @ % vs @ % ; reader @ , @ % vs @ % ) .


Lower tube potential ( @ kV ) for cardiothoracic CT could be accompanied by a @ % reduction in contrast volume with satisfactory aortic blood-pool attenuation in most patients .


More personalized adaptation of the contrast protocol that takes into account patient characteristics and tube potential is necessary to ensure sufficient contrast enhancement for all patients .


A low response to controlled ovarian hyperstimulation implies a reduced number of embryos and impaired pregnancy rate .


Follicular priming with steroids before controlled ovarian hyperstimulation has been suggested to improve the subsequent ovarian response .


The purpose of this study was to determine the best follicular priming protocol in low responders and to investigate the intrafollicular mechanisms triggered by steroid hormone priming .


This was a single-center , randomized , parallel , open-label , controlled trial , in two phases .


The setting was a university-based in vitro fertilization unit .


Potential low responders ( n = @ ) underwent a first intracytoplasmic sperm injection cycle .


Confirmed low responders ( n = @ ) were randomized to different priming protocols before a new intracytoplasmic sperm injection .


Randomized patients underwent one of the following priming strategies : transdermal testosterone ( @ g/kg/d ) , transdermal estradiol ( @ g/d ) , or combined estrogens and oral contraceptive pills ( @ g of ethinyl estradiol plus @ g of desogestrel administered during the luteal phase of two consecutive cycles ) and @ mg/d of estradiol valerate during the follicular phase between them .


Metaphase II ( MII ) oocytes were retrieved .


Gene expression levels in the granulosa cells of steroidogenesis enzymes and FSH , LH , and androgen receptors were measured .


The number of retrieved MII oocytes did not differ between the interventional groups ( testosterone , @ @ ; estrogen , @ @ ; and combined estrogens and oral contraceptive pills , @ @ ; not significant ) .


Compared with those in nonprimed cycles , estradiol pretreatment yielded more MII oocytes ( primed , @ @ ; nonprimed , @ @ ; P = @ ) although the clinical pregnancy rate was higher in patients treated with testosterone ( P = @ ) .


Testosterone pretreatment increased androgen receptor expression ( P = @ ) compared with that for the previous cycle without priming .


The results of the present trial do not support the superiority of one priming strategy over the others .


Tumor necrosis factor ( TNF ) and , possibly , lymphotoxin alpha ( LT ) signaling contribute to inflammation and rheumatoid arthritis ( RA ) pathogenesis .


Pateclizumab ( anti-lymphotoxin - alpha ; MLTA@A ) is a humanized monoclonal antibody that blocks and depletes anti-LT .


This phase @ , randomized , head-to-head , active - and placebo-controlled trial examined the safety and efficacy of pateclizumab compared to adalimumab in RA patients with an inadequate response to disease-modifying antirheumatic drugs ( DMARD-IR ) .


Patients ( n = @ ) with active RA ( @ swollen and tender joints , C-reactive protein @ mg/L ) on oral DMARDs were randomized ( @:@:@ ) to receive pateclizumab @ mg , adalimumab @ mg , or placebo subcutaneously every @ weeks .


The primary endpoint , @-variable , @-joint disease activity score erythrocyte sedimentation rate ( DAS@ ( @ ) - ESR ) response , was evaluated at @ weeks using an analysis of covariance ( ANCOVA ) model with adjustments for concomitant DMARD use and geographic region .


Secondary efficacy endpoints included American College of Rheumatology ( ACR ) @ , ACR@ , and ACR@ responses at Day @ .


Pharmacokinetics , pharmacodynamics , and immunogenicity of pateclizumab were assessed .


Pateclizumab reduced the DAS@ ( @ ) - ESR response ( -@ ) at @ weeks , however , this did not reach statistical significance compared to placebo ( -@ ) , while adalimumab ( -@ ) differed significantly from both placebo and pateclizumab .


Pateclizumab @-week ACR@ , ACR@ and ACR@ response rates ( @ % , @ % , and @ % ) suggested clinical activity but were not statistically significant compared to placebo rates ( @ % , @ % , and @ % , respectively ) .


CXCL@ serum levels decreased significantly following pateclizumab and adalimumab administration , demonstrating pharmacological target engagement by both drugs .


Overall , adverse events ( AEs ) were comparable among all cohorts .


Infections were the most common AE , occurring with comparable frequency in all groups .


Serious AEs occurred in @ % of pateclizumab , @ % of adalimumab , and @ % of placebo patients , with serious infection in @ % of adalimumab patients and none in pateclizumab and placebo patients .


Pateclizumab had a good safety profile in patients inadequately responsive to DMARDs , but no statistically significant improvement in RA signs and symptoms after @ weeks of treatment .


Adalimumab demonstrated efficacy and safety comparable to published results in this head-to-head comparison in DMARD-IR RA patients .


To observe the effect and safety of plastering Chinese Compound Shenhuang Ointment ( CSO ) at Shenque ( RN@ ) in promoting the rehabilitation of postoperative gastrointestinal dysfunction patients of qi stagnation blood stasis syndrome ( QSBSS ) .


A prospective , multi-centered , randomized , double-blinded , controlled trial was conducted in @ postoperative gastrointestinal dysfunction patients of QSBSS .


They were randomly assigned to two groups , the CSO group ( @ cases ) and the placebo group ( @ cases ) .


CSO was plastered at Shenque ( RN@ ) for @ days after operation .


The time of exhaustion , defecation , the recovery of intestinal peristalsis , integrals of TCM syndrome , and serum levels of motilin ( MOT ) and somatostatin ( SS ) were observed .


Compared with the placebo group , the condition of exhaustion and defecation , the recovery of intestinal peristalsis on the @rd day after operation was all improved ( P < @ ) .


The integrals of TCM syndrome at day @ , @ , and @ were more significantly lowered in the CSO group than in the placebo group ( P < @ , P < @ ) .


The total effective rate of TCM syndrome was @ % in the CSO group , better than that in the placebo group ( @ % , P < @ ) .


Compared with the placebo group , the serum MOT level increased and the serum SS level decreased at day @ after operation in the CSO group ( P < @ ) .


The plastering of CSO at Shenque ( RN@ ) could advance the time of exhaustion and defecation , and improve patients ' clinical symptoms .


And patients could tolerate well .


To investigate the feasibility of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting ( OPCABG ) .


Upon the approval of institutional Ethics Committee and informed consent , forty patients ASAII or III aged @-@ yr with BMI ( body mass index ) < @ kg/m ( @ ) , undergoing OPCABG , were randomly divided by random numbers into two groups ( n = @ each ) : thoracic paravertebral block for postoperative analgesia group ( group P ) and patient-controlled intravenous analgesia ( PCIA ) group ( group I ) .


Bilateral thoracic paravertebral block and insertion epidural catheter were performed at T@ , @ interspace prior to induction of anesthesia in group P.


At the end of the operation , an infusion of @ % ropivacaine was injected at the rate of @ ml/h up to @ h.Group I received PCIA with morphine .


Dermatomes of hypoalgesia in group P were recorded .


The following indexes were recorded at @ , @ , @ and @ hours after postoperative analgesia beginning : VAS scores of rest pain , cough pain and sedation score .


To evaluate stability of circulation .


Cycle time , complications and side effects after operation were recorded .


Dermatomes of hypoalgesia was @ @ segments in group P. VAS scores of rest pain ( @ @ , @ @ , @ @ , @ @ vs @ @ , @ @ , @ @ , @ @ , all P < @ ) , cough pain ( @ @ , @ @ , @ @ , @ @ vs @ @ , @ @ , @ @ , @ @ , P < @ , < @ ) and sedation scores ( @ @ , @ @ , @ @ , @ @ , @ @ , @ @ , @ @ , @ @ , P < @ ) in group P were significantly lower than in group I at the four points .


The incidences of sinus tachycardia ( @ % vs @ % ) and hypertension ( @ vs @ % ) in group P were significantly reduced than in group I ( P < @ ) , and there were no significant difference in the incidences of sinus brachycardia ( @ % vs @ % ) and hypotension ( @ % vs @ % ) ( P > @ ) .


Compared with group I , extubation time ( @ @ vs @ @ ) and residence time in ICU ( @ @ vs @ @ ) were shortened significantly in group P ( P < @ ) , and there were no significant difference in length of stay after operation ( @ @ vs @ @ , P > @ ) .


The incidence rate of nausea in group P was significantly lower than in group I ( @ % vs @ % , P < @ ) , and there were no significant difference in the other complications and side effects after operation ( P > @ ) .


Bilateral thoracic paravertebral block for postoperative analgesia could be used safely and efficiently and accelerate the cycle time in patients after OPCABG .


Bone loss and subclinical diabeteslike are developed during long-term spaceflight .


Recently , it was demonstrated that bone was able to regulate energy metabolism and testosterone synthesis via osteocalcin .


The aim of this study was to determine whether serum osteocalcin level is associated with glycolipid metabolism or testosterone under the influence of microgravity with or without resistive vibration exercise ( RVE ) .


A total of @ healthy adult male volunteers ( @-@years ) were randomly assigned to two groups ( n = @ each ) : control ( CON ) group and RVE group .


Radioimmunoassay kits and ELISA kits were used for measurement of serum indices .


During @-day bed rest , serum osteocalcin of both groups increased at day @ during bed rest .


Serum OPG started decreasing and reached its lowest value at day @ during bed rest .


In control group , serum insulin increased at day @ during bed rest .


IGF-I did not change significantly during the entire period of bed rest .


The serum glucose decline @ % and @ % in CON and RVE groups at day @ during bed rest .


Relatively , the same results as glucose were found in serum HDL and LDL for both groups .


Leptin rose and became highest at day @ during bed rest in both groups .


The level of serum testosterone was declined in control group at day @ during bed rest .


Cortisol kept stable in both group during bed rest .


By spearman correlation analysis , serum osteocalcin was significantly associated with serum insulin ( P < @ ) , LDL ( P < @ ) and Leptin ( P < @ ) .


Our findings suggested that the mutual regulation may exist between skeletal and energy metabolism under simulated microgravity .


Segmental muscle vibration ( SMV ) improves motor performances in neurological conditions , including stroke .


To determine if SMV modifies upper limb muscular activity in chronic stroke patients performing a reaching movement .


We randomized @ chronic stroke patients to an experimental group ( EG ; n = @ ) , receiving @ sessions of exercise + @ Hz SMV over the biceps brachii ( BB ) and the flexor carpi ulnaris ( FCU ) muscles , or to a control group ( CG ; n = @ ) receiving exercise only .


All subjects performed a reaching movement with the affected side before and @ weeks after therapy ended .


We recorded surface EMG activity of the anterior deltoid ( AD ) , posterior deltoid ( PD ) , BB , triceps brachii ( TB ) , FCU and extensor carpi radialis ( ECR ) muscles .


We calculated muscular onset times , modulation ratio , co-contractions and degree of contraction .


After SMV , onset times of the PD ( p = @ ) , BB ( p = @ ) and ECR ( p = @ ) in the EG were less anticipated than at baseline ; the modulation ratio increased in AD ( p = @ ) and BB ( p = @ ) ; co-contractions decreased in the pairs BB/TB ( p = @ ) , PD/BB ( p = @ ) and AD/BB ( p = @ ) ; and the degree of contraction decreased in BB ( p = @ ) .


The modulation of muscular function induced by SMV may aid to explain its action on smoothness and coordination of movements .


The objective of this study is to assess the efficacy of an intervention designed to promote resilience in young children living with their HIV-positive mothers .


HIV-positive women attending clinics in Tshwane , South Africa , and their children , aged @-@ years , were randomized to the intervention ( I ) or standard care ( S ) .


The intervention consisted of @ weekly group sessions led by community care workers .


Mothers and children were in separate groups for @ sessions , followed by @ interactive sessions .


The primary focus was on parent-child communication and parenting .


Assessments were completed by mothers and children at baseline and @ , @ and @ months .


Repeated mixed linear analyses were used to assess change over time .


Of @ mother-child pairs , @ % ( I : @ and S : @ ) completed at least two interviews and were included in the analyses .


Children 's mean age was @ years and @ % of mothers had been ill in the prior @ months .


Attendance in groups was variable : only @ % attended more than @ sessions .


Intervention mothers reported significant improvements in children 's externalizing behaviours ( = -@ , P = @ ) , communication ( = @ , P = @ ) and daily living skills ( = @ , P = @ ) , although improvement in internalizing behaviours and socialization was not significant ( P = @ and @ , respectively ) .


Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence .


This is the first study demonstrating benefits of an intervention designed to promote resilience among young children of HIV-positive mothers .


The intervention was specifically designed for an African context and has the potential to benefit large numbers of children , if it can be widely implemented .


Data about the vaccination status of participants are required in epidemiological cohort studies whenever infection or immunity is considered as potential exposure or outcome .


Within Pretest @ of the German National Cohort ( GNC ) we therefore investigated the acceptance and feasibility of extracting vaccination status from vaccination certificates provided by the participants of the study .


This study was conducted in three study centers ( Bremen , n = @ ; Hamburg , n = @ ; Hannover , n = @ ) .


In order to test if an additional reminder would prevent participants from forgetting their vaccination certificates at home persons willing to participate in Pretest @ were randomly assigned to one of three invitation groups ( IG ) .


About one third of the participants received either no further reminder ( IG@ ) , a reminder card together with the appointment letter ( IG@ ) or a separate reminder card @ days before the appointment ( IG@ ) .


At the study center , vaccination data were scanned or copied and entered into a database using a unique identification number .


Participants were also asked to fill in a short questionnaire to assess the completeness of the provided vaccination data .


Additionally , in one of the three participating study centers , general practitioners ( GP ) were asked to provide vaccination data from their records following respective participants ' consent .


Finally , we compared the influenza data from the vaccination certificates with the influenza data obtained from participants in Pretest @ by use of a self-administered questionnaire ( ID-Screen ) .


Due to different starting dates of the study the intended reminder procedure was implemented only in Hamburg and Hannover .


In Hamburg , significantly more vaccination certificates were submitted by the group which received the reminder card separately @ days before the examination ( IG@ ) compared to IG@ and IG@ ( p = @ ) .


In Hannover , in contrast , most vaccination certificates were brought by those who received the reminder card together with the appointment letter .


Overall , the use of a reminder card had a positive but not significant effect as @ % ( @/@ ) of participants who received the reminder card submitted vaccination data versus @ % ( @/@ ) of participants who did not receive any reminder card ( p = @ ) .


Of all Pretest @ participants in Hannover , @ % ( @/@ ) gave written consent for data collection by the GPs .


In total , @ practices were contacted of which @ ( @ % ) sent vaccination data .


All in all , @ vaccination certificates with @ documented vaccinations were entered into a database , of which @ ( @ % ) were valid for analysis covering a period from @ to @ .


The comparison of influenza vaccination data from vaccination certificates to the remembered data from a self-completed questionnaire showed an agreement of data in @ % ( @/@ ) of cases ( Kappa = @ ) .


Influenza vaccinations were underreported in @ % ( @/@ ) of self-completed questionnaires .


The reliable documentation of vaccinations within the context of the GNC proved to be feasible and thus recommendable at a large scale within the GNC as participants showed high willingness and compliance in providing available vaccination documents .


An additional validation by means of documents provided by physicians seems to be possible for more than a quarter of participants .


In order to maximize the likelyhood of participants ' of bringing their vaccination certificates it would be sufficient to send a reminder card together with the appointment letter .


Successful recruitment and retention of participants into research studies is critical for optimising internal and external validity .


Research into diet and lifestyle of young women is important due to the physiological transitions experienced at this life stage .


This paper aims to evaluate data related to recruitment and retention across three research studies with young women , and present practical advice related to recruiting and retaining young women in order to optimise study quality within nutrition research .


Recruitment and retention strategies used in three nutrition studies that targeted young women ( @ to @ years ) were critiqued .


A randomised controlled trial ( RCT ) , a crossover validation study and a cross-sectional survey were conducted at the University of Newcastle , Australia between @ and @Successful recruitment was defined as maximum recruitment relative to time .


Retention was assessed as maximum participants remaining enrolled at study completion .


Recruitment approaches included notice boards , web and social network sites ( Facebook and Twitter ) , with social media most successful in recruitment .


The online survey had the highest recruitment in the shortest time-frame ( @ participants in one month ) .


Email , phone and text message were used in study one ( RCT ) and study two ( crossover validation ) and assisted in low attrition rates , with @ % and @ % completing the RCT and crossover validation study respectively .


Of those who did not complete the RCT , reported reasons were : being too busy ; and having an unrelated illness .


Recruiting young women into nutrition research is challenging .


Use of social media enhances recruitment , while Email , phone and text message contact improves retention within interventions .


Further research comparing strategies to optimise recruitment and retention in young women , including flexible testing times , reminders and incentives is warranted .


Approximately @ % of vaginal deliveries are accompanied by perineal trauma .


The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth .


The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma .


This is a single-centre , randomized controlled trial , with computer-generated randomization in a @:@ allocation ratio .


Women planning their first vaginal delivery ( n = @ ) are randomized to primary delivery of either the anterior or posterior shoulder .


The primary outcome is any perineal trauma .


Additional outcomes are the perineal injury subtypes , postpartum bleeding , umbilical artery pH , Apgar score at @minutes and any neonatal birth trauma .


Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery .


All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears .


The trial is being undertaken at a Danish community hospital with @,@ yearly deliveries .


Data will be analyzed according to the intention-to-treat principle .


Recruitment started in January @ and the trial is planned to proceed for @months .


Most delivery assistance techniques are based on tradition and heritage and lack objective evidence .


This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial .


The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique .


We investigated the effects of intracoronary transplantation of CD@ ( + ) cells on myocardial perfusion in patients with nonischemic dilated cardiomyopathy ( DCM ) .


We enrolled @ patients with DCM ( left ventricular ejection fraction -LSB- LVEF -RSB- < @ % , New York Heart Association functional class III ) who underwent peripheral stem cell mobilization with granulocyte-colony stimulating factor ( G-CSF ) .


CD@ ( + ) cells were collected by means of apheresis .


Patients underwent myocardial perfusion imaging , and CD@ ( + ) cells were injected in the coronary artery supplying viable segments with reduced myocardial perfusion and regional dysfunction .


Myocardial perfusion imaging was repeated @ months later .


Clinical response to stem cell therapy was predefined as a change in LVEF > @ % .


The majority of patients were men ( @ % ) with an overall mean age @ @ years , LVEF @ @ % , and @-minute walking distance @ @ m. Myocardial perfusion defects at rest were observed in @ % of patients and were more common in the left anterior descending territory ( @ % ) .


At @ months ' follow-up , there was a significant improvement in rest myocardial perfusion scores ( @ @ vs @ @ ; P < @ ) , LVEF ( @ @ % vs @ @ % ; P = @ ) , and @-minute walking distance ( @ @ m vs @ @ m ; P < @ ) .


Responders to stem cell therapy had lower summed rest perfusion score at both baseline ( @ @ vs @ @ ; P = @ ) and follow-up ( @ @ vs @ @ ; P = @ ) .


CD@ ( + ) cell transplantation may lead to improved myocardial perfusion in patients with nonischemic DCM .


Patients with less severe myocardial perfusion defects at baseline may have an increased likelihood to respond to intracoronary CD@ ( + ) cell transplantation .


Appropriate guideline criteria for use of implantable cardioverter-defibrillators ( ICDs ) do not take into account potential recovery of left ventricular ejection fraction ( LVEF ) in patients treated with CRT-defibrillator .


Patients randomized to CRT-defibrillator from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ( MADIT-CRT ) trial who survived and had paired echocardiograms at enrollment and at @ months ( n = @ ) were included .


Patients were evaluated by LVEF recovery in @ groups ( LVEF @ % -LSB- reference -RSB- , @ % -@ % , and > @ % ) on outcomes of ventricular tachyarrhythmias ( VTAs ) , VTA @ bpm , ICD shock , heart failure or death , and inappropriate ICD therapy by multivariable Cox models .


A total of @ % achieved LVEF normalization ( > @ % ) .


The average follow-up was @ years .


The risk of VTA was reduced in patients with LVEF > @ % ( hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ) and LVEF of @ % to @ % ( HR , @ ; @ % CI , @-@ @ ; P < @ ) .


Among patients with LVEF > @ % , only @ patient had VTA @ bpm ( HR , @ ; @ % CI , @-@ @ ) , none were shocked by the ICD , and @ died of nonarrhythmic causes .


The risk of HF or death was reduced with improvements in LVEF ( LVEF > @ % : HR , @ ; @ % CI , @-@ @ ; P = @ ; and LVEF of @ % -@ % : HR , @ ; @ % CI , @-@ @ ; P < @ ) .


For inappropriate ICD therapy , no additional risk reduction for LVEF > @ % was seen compared with an LVEF of @ % to @ % .


A total of @ factors were associated with LVEF normalization , and patients with all factors present ( n = @ ) did not experience VTAs ( positive predictive value , @ % ) .


Patients who achieve LVEF normalization ( > @ % ) have very low absolute and relative risk of VTAs and a favorable clinical course within @ years of follow-up .


Risk of inappropriate ICD therapy is still present , and these patients could be considered for downgrade from CRT-defibrillator to CRT-pacemaker at the time of battery depletion if no VTAs have occurred .


Animal models suggest that neuroactive steroids contribute to alcohol 's acute effects .


We previously reported that a common nonsynonymous polymorphism , AKR@C@ @ in the gene encoding the enzyme @-HSD@ / @-HSD@ , and a synonymous single nucleotide polymorphism ( SNP ) , rs@ , in SRD@A@ , which encodes @-reductase , were associated with alcohol dependence ( AD ) .


The aim of the study was to investigate whether these polymorphisms moderate subjective effects of alcohol in humans and whether AKR@C@ @ affects neuroactive steroid synthesis .


Sixty-five Caucasian men ( @ lighter and @ heavier drinkers ; mean age @ years ) participated in a double-blind laboratory study where they consumed drinks containing no ethanol or @ g/kg of ethanol .


Breath alcohol , heart rate ( HR ) , and self-reported alcohol effects were measured at @-min intervals , and genotype was examined as a moderator of alcohol 's effects .


Levels of the neuroactive steroid @-androstane-@ ,@ - diol and its precursors , @,@-androsterone and dihydrotestosterone , were measured at study entry using GC/MS .


Initially , carriers of the AD-protective AKR@C@ @G allele had higher levels of @-androstane-@ ,@ - diol relative to the precursor @,@-androsterone than C allele homozygotes .


AKR@C@ @G allele carriers exhibited greater increases in heart rate and stimulant and sedative effects of alcohol than C allele homozygotes .


The genotype effects on sedation were observed only in heavier drinkers .


The only effect of the SRD@A@ SNP was to moderate HR .


There were no interactive effects of the two SNPs .


The observed effects of variation in a gene encoding a neuroactive steroid biosynthetic enzyme on the rate of @-reduction of androsterone relative to androstanediol and on alcohol 's sedative effects may help to explain the association of AKR@C@ @ with AD .


Hyperhomocysteinemia is associated with arterial stiffness , but underlying pathophysiological mechanisms explaining this association are to be revealed .


This study was aimed to explore two potential pathways concerning the one-carbon metabolism .


A potential causal effect of homocysteine was explored using a genetic risk score reflecting an individual 's risk of having a long-term elevated plasma homocysteine level and also associations with B-vitamin levels were investigated .


Baseline cross-sectional data of the B-PROOF study were used .


In the cardiovascular subgroup ( n = @ , @ % male , age @ yrs ) pulse wave velocity ( PWV ) was determined using applanation tonometry .


Plasma concentrations of vitamin B@ , folate , methylmalonic acid ( MMA ) and holo transcobalamin ( holoTC ) were assessed and the genetic risk score was based on @ SNPs being associated with elevated plasma homocysteine .


Associations were examined using multivariable linear regression analysis .


B-vitamin levels were not associated with PWV .


The genetic risk score was also not associated with PWV .


However , the homocysteine-gene interaction was significant ( p < @ ) in the association of the genetic risk score and PWV .


Participants with the lowest genetic risk of having long-term elevated homocysteine levels , but with higher measured homocysteine levels , had the highest PWV levels .


Homocysteine is unlikely to be causally related to arterial stiffness , because there was no association with genetic variants causing hyperhomocysteinemia , whereas non-genetically determined hyperhomocysteinemia was associated with arterial stiffness .


Moreover , the association between homocysteine and arterial stiffness was not mediated by B-vitamins .


Possibly , high plasma homocysteine levels reflect an unidentified factor , that causes increased arterial stiffness .


Vorinostat is a histone deacetylase inhibitor that changes gene expression and protein activity .


On the basis of the clinical benefit reported in patients with malignant pleural mesothelioma treated in a phase @ study of vorinostat , we designed this phase @ trial to investigate whether vorinostat given as a second-line or third-line therapy improved patients ' overall survival .


This double-blind , randomised , placebo-controlled trial was done in @ international centres .


Patients with measurable advanced malignant pleural mesothelioma and disease progression after one or two previous systemic regimens were eligible .


After stratification for Karnofsky performance status , histology , and number of previous chemotherapy regimens , patients were randomly assigned ( @:@ ) by use of an interactive voice response system with a block size of four to either treatment with vorinostat or placebo .


Patients received oral vorinostat @ mg ( or matching placebo ) twice daily on days @ , @ , @ , @ , @ , @ , @ , @ , and @ of a @-day cycle .


The primary endpoints were overall survival and safety and tolerability of vorinostat .


The primary efficacy comparison was done in the intention-to-treat population , and safety and tolerability was assessed in the treated population .


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


From July @ , @ , to Feb @ , @ , @ patients were enrolled and randomly assigned to receive either vorinostat ( n = @ ) or placebo ( n = @ ) and included in the intention-to-treat analysis .


Median overall survival for vorinostat was @ weeks ( @ % CI @-@ ) versus @ weeks ( @-@ ) for placebo ( hazard ratio @ , @ % CI @-@ , p = @ ) .


The most common grade @ or worse adverse events for patients treated with vorinostat were fatigue or malaise ( @ -LSB- @ % -RSB- patients in the vorinostat group vs @ -LSB- @ % -RSB- in the placebo group -RSB- ) and dyspnoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


In this randomised trial , vorinostat given as a second-line or third-line therapy did not improve overall survival and can not be recommended as a therapy for patients with advanced malignant pleural mesothelioma .


Delirium ( or acute confusion ) is a serious illness common in older people , in which a person 's thinking and perceptions may be affected .


Reducing delirium is important because of the considerable distress it causes , and the poor outcomes associated with it , such as increased admissions to hospital , falls , mortality and costs to the National Health Service ( NHS ) .


Preventing delirium is possible using multicomponent interventions ; successful interventions in hospitals have reduced it by one-third .


However , there is little research to guide practice in care homes , where it is common because of the clustering of known risk factors ( older age , frailty , and dementia ) .


In previous work we developed a multicomponent intervention to prevent delirium in care homes , called Stop Delirium !


The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice .


Before starting a large costly trial of Stop Delirium !


, this pilot study will test and help improve the design and feasibility of the trial protocol .


We plan to conduct a cluster randomised pilot trial in @ care homes ( independent residential and nursing ) .


Following recruitment of residents ( over @ years , consenting or with consultee agreement , able to communicate in English , and not in palliative care ) participating homes will be randomised , stratified by size of home and proportion of residents with dementia .


Stop Delirium !


will be delivered to intervention homes over @ months , with controls receiving usual care .


The primary outcome measure will be the presence of delirium on any day during a one-month post-intervention period.We will collect data to determine @ ) recruitment and attrition rates , @ ) feasibility of various outcomes measurements , and @ ) feasibility of capturing health resource use ( resident diaries and by examining health records ) .


We will estimate the between-cluster variation for the primary outcome , delirium occurrence .


This pilot study will refine methods for the definitive trial .


The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence ( NICE ) delirium guidelines , which recommend multicomponent interventions for delirium prevention .


( @ ) Compare tolerance of aerosolized spray versus syringe administration of topical anesthesia for transnasal flexible laryngoscopy ( TFL ) , ( @ ) analyze cost-effectiveness of both techniques .


Prospective , blinded , randomized trial .


Tertiary academic laryngology practice .


One hundred and eight patients underwent TFL over @ months .


Patients were randomized to receive equivalent dose @:@ neosynephrine/@ % plain lidocaine mixture via aerosolized spray ( `` spray '' ) or application with @-cc syringe ( `` syringe '' ) .


Patients and physicians independently rated comfort of TFL on @-point scale ( @ = not at all comfortable to @ = very comfortable ) .


Data were collected on patient and endoscopist experience with TFL and reasons for poor tolerance of laryngoscopy .


Cost analyses of disposable spray tips and syringes were calculated .


Both patients and physicians reported very high tolerance of TFL .


Patient tolerance appears to be similar between spray - versus syringe-administered anesthesia , although study limitations preclude definitive analysis .


Poor tolerance of laryngoscopy was reported in @ % with comparable distribution between anesthetic delivery methods .


There was no impact of patient prior experience with TFL , and there was no difference between anesthetic methods for TFL performed by resident , fellow , or attending .


The difference between costs of the disposable spray tip versus syringe was $ @ per unit .


Use of a @-cc syringe is an effective method to provide topical nasal anesthesia for TFL and saves $ @ per unit compared to disposable spray tips .


In our practice , transition to syringe-administered nasal anesthesia is projected to save $ @ per @ patients , or an anticipated $ @ per year per physician , with excellent patient tolerance of TFL .


No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients .


Overall , @ patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port , either through a percutaneous landmark access to the internal jugular vein , an ultrasound ( US ) - guided access to the subclavian vein , or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove .


Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use , while the costs of the management of complications were analytically assessed .


The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications , if any .


A total of @ patients were evaluable-@ with the internal jugular vein , @ with the subclavian vein and @ with the cephalic vein access .


No differences were found for the rate of early complications .


The US-guided subclavian insertion site had significantly lower failures .


Infections occurred in @ , @ , and @ patients ( internal jugular , subclavian , and cephalic access , respectively ; p = @ ) , whereas venous thrombosis was observed in @ , @ , and @ patients , respectively ( p = @ ) .


Mean cost for purchase , implantation , diagnosis and treatment of complications in each patient was <euro> @,@ for subclavian US-guided , <euro> @,@ for cephalic , and <euro> @,@ for internal jugular access , respectively ( p = @ ) .


US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use .


This study compares the effect of heliox-driven to that of air-driven bronchodilator therapy on the pulmonary function test ( PFT ) in patients with different levels of asthma severity .


One-hundred thirty-two participants were included in the study .


Participants underwent spirometry twice with bronchodilator testing on two consecutive days .


Air-driven nebulization was used one day and heliox-driven nebulization the other day in random order crossover design .


After a baseline PFT , each participant received @ mg of albuterol sulfate nebulized with the randomized driving gas .


Post bronchodilator PFT was repeated after @ min .


The next day , the exact same protocol was repeated , except that the other driving gas was used to nebulize the drug .


Participants were subgrouped and analyzed according to their baseline FEV ( @ ) on day @ : Group I , FEV ( @ ) @ % ; Group II , @ % > FEV ( @ ) > @ % ; Group III , FEV ( @ ) @ % .


The proportion of participants with greater than @ % and @-mL increases from their baseline FEV ( @ ) and the changes from baseline in PFT variables were compared between heliox-driven versus air-driven bronchodilation therapy .


The proportion of participants with > @ % and @-mL increases from their baseline FEV ( @ ) with air - or heliox-driven bronchodilation was not different with respect to the proportion of participants with baseline FEV ( @ ) @ % ( @ vs. @ % , respectively ) and @ % > FEV ( @ ) > @ % ( @ vs. @ % , respectively ) , but it was significantly greater with heliox-driven bronchodilation in participants with FEV ( @ ) @ % ( @ vs. @ % , respectively ; p = @ ) .


Changes from baseline FVC , FEV ( @ ) , FEV ( @ ) / FVC , FEF ( @-@ ) % , FEF ( max ) , FEF ( @ ) % , FEF ( @ ) % , and FEF ( @ ) % were significantly larger with heliox-driven versus air-driven bronchodilation in participants with baseline FEV ( @ ) @ % .


Improvements in PFT variables are more frequent and profound with heliox-driven compared to air-driven bronchodilator therapy only in asthmatic patients with baseline FEV ( @ ) @ % .


A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis .


In @ , a @-week study in birch pollen-allergic children showed a reduction in nasal symptoms .


The best effect occurred on days with lower pollen counts .


The present study in grass pollen-allergic adults used the same basic design .