The coprimary outcome measures were patient rate of falls per @ patient-days and the proportion of patients who were fallers .


All analyses were by intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials registry , number ACTRN@ ) .


Between Jan @ , and Dec @ , @ , @ patients were admitted to the eight units ( n = @ control period ; n = @ intervention period ) .


There were fewer falls ( n = @ , @/@ patient-days vs n = @ , @/@ patient-days , adjusted rate ratio @ -LSB- robust @ % CI @-@ -RSB- , p = @ ) , injurious falls ( n = @ , @/@ patient-days vs @ , @/@ patient-days , @ -LSB- robust @ % CI @-@ -RSB- , p = @ ) , and fallers ( n = @ -LSB- @ % -RSB- vs n = @ -LSB- @ % -RSB- adjusted odds ratio @ -LSB- robust @ % CI @ to @ -RSB- , p = @ ) in the intervention compared with the control group .


There was no significant difference in length of stay ( intervention median @ days -LSB- IQR @-@ -RSB- , control @ days -LSB- @-@ -RSB- ) .


Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units .


Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses .


This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents , thiopentone sodium and propofol , and also to compare the undesired responses occurring during LMA insertion with them .


The study was prospective , randomized , and double blind .


All patients selected were randomly allocated into two groups : Group @ ( propofol ) and group II ( thiopentone ) .


Preinduction heart rate and blood pressure were recorded .


Sixty healthy adult patients of either sex belonging to age group of @-@ years and ASA grade I or II , to undergo surgery less than @ h , were selected for the study-Patients were randomly allocated in two groups , @ in each group .


Premedication with midazolam @ mg/kg and fentanyl @ mg/kg done in both groups .


Thereafter , group @ was induced with @ mg/kg of propofol and group @ with @ mg/kg of thiopentone sodium .


The study revealed that , ease of insertion of LMA , was statistically significantly greater in group @ when compared with group @ ( P @ ) .


The time required for successful insertion of LMA was lesser in group @ patients ( @ @ s ) than in group @ patients ( @ @ s ) ( P @ ) .


Severity of undesired responses were more in group @ , as incremental boluses of respective induction agents were required in @ % patients in thiopentone group compared to only @ % patients in propofol group and @ % of patients in thiopentone group required rescue succinylcholine .


South Africa has a high and rising prevalence of hypertension .


Many affected individuals are not using medication , and few have controlled blood pressure .


Until recently , primary care clinics focused on maternal and child health and management of acute conditions , but new government initiatives have shifted the focus to chronic diseases , including HIV/AIDS and hypertension .


The Nkateko trial will test the effectiveness of clinic-based lay health workers ( LHWs ) in supporting hypertension management .


It is a pragmatic , cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa , and it is underpinned by long-term health and demographic surveillance .


Eight primary care facilities , with their catchment communities , are randomised to usual care or the addition of LHWs focused on chronic care .


All clinics ( intervention and control ) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records .


Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions , particularly hypertension .


The LHWs will be supported by an implementation manager , who will work with clinic staff to develop the most effective role for the LHWs .


Control clinics will continue to provide usual care .


The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease .


A process evaluation will be based on a realist approach using patient exit interviews , clinic observations and interviews with health professionals , LHWs and patients to document the intervention and its implementation .


There are challenges in the design of this trial .


Assessing change through population surveys may reduce measurable effects ; however , we feel this is appropriate because we aim to attract those who currently do not use clinics , and we hope to improve care for clinic users .


Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community .


We are constantly working to achieve an effective balance between the intervention and process evaluations .


Little evidence exists on whether effects of an early obesity intervention are sustainable .


To assess the sustainability of effects of a home-based early intervention on children 's body mass index ( BMI ) and BMI z score at @ years after intervention .


A longitudinal follow-up study of the randomized clinical Healthy Beginnings Trial was conducted with @ participating mothers consenting to be followed up at @ years after intervention until their children were age @ years .


This study was conducted in socially and economically disadvantaged areas of Sydney , Australia , from March @ to June @ .


No further intervention was carried out in this Healthy Beginnings Trial phase @ follow-up study .


The original intervention in phase @ comprised @ home visits from community nurses delivering a staged home-based intervention , with one visit in the antenatal period and @ visits at @ , @ , @ , @ , @ , @ , and @ months after birth .


Primary outcomes were children 's BMI and BMI z score .


Secondary outcomes included dietary behaviors , quality of life , physical activity , and TV viewing time of children and their mothers .


In total , @ mothers and their children completed the follow-up study , a phase @ completion rate of @ % ( @ % for the intervention group and @ % for the control group ) .


The differences between the intervention and control groups at age @ years in children 's BMI and BMI z score disappeared over time .


At age @ years , the difference ( intervention minus control ) in BMI ( calculated as weight in kilograms divided by height in meters squared ) was -@ ( @ % CI , -@ to -@ ; P = @ ) , but by age @ years it was @ ( @ % CI , -@ to @ ) .


No effects of the early intervention on dietary behaviors , quality of life , physical activity , and TV viewing time were detected at age @ years .


The significant effect of this early life home-visiting intervention on child BMI and BMI z score at age @ years was not sustained at age @ years without further intervention .


Obesity prevention programs need to be continued or maintained during the early childhood years .


Changes in gut motor and hormonal function contribute to the eating-inhibitory and glucose-lowering effects of protein .


The effect of amino acids , the digestive products of protein , on gastrointestinal function , eating , and glycemia has not been investigated comprehensively .


We tested the hypothesis that L-tryptophan ( L-Trp ) stimulates gastrointestinal motor and hormonal functions , inhibits eating , and modulates glycemia .


Design , Settings , Participants , and Intervention : Ten healthy , normal-weight men were studied in randomized , double-blind fashion , each receiving a @-minute intraduodenal infusion of L-Trp at @ ( total @ kcal ) or @ ( total @ kcal ) kcal/min or saline ( control ) .


Antropyloroduodenal motility , plasma ghrelin , cholecystokinin , glucagon-like peptide-@ , peptide tyrosine tyrosine , insulin , glucagon , blood glucose , and appetite perceptions were measured .


Food intake was quantified from a buffet meal after the infusion .


Intraduodenal L-Trp suppressed antral pressures ( P < @ ) and stimulated pyloric pressures ( P < @ ) and markedly increased cholecystokinin and glucagon ( both P < @ ) .


Glucagon-like peptide-@ and peptide tyrosine tyrosine increased modestly ( both P < @ ) , but there was no effect on total ghrelin .


Insulin increased slightly ( P < @ ) without affecting blood glucose .


Plasma L-Trp increased substantially ( P < @ ) .


All effects were dose-related and associated with increased fullness and substantially decreased energy intake ( P < @ ) .


There was a strong inverse correlation between energy intake and plasma L-Trp ( r = -@ ; P < @ ) .


Low caloric intraduodenal loads of L-Trp affect gut motor and hormonal function and markedly reduce energy intake .


A strong inverse correlation between energy intake and plasma L-Trp suggests that , beyond gut mechanisms , direct effects of circulating L-Trp mediate its eating-inhibitory effect .


To examine characteristics of ocular hypertensive subjects and potential associations with estimated cerebrospinal fluid pressure ( estCSFP ) .


The population-based Beijing Eye Study @ included @ individuals with a mean age of @ years .


Ocular hypertension was defined as intraocular pressure ( IOP ) > @ mmHg , normal optic nerve head appearance and normal retinal nerve fiber layer thickness .


IOP was corrected for its dependence on central corneal thickness ( CCT ) and corneal curvature radius .


Estimated CSFP was calculated as CSFP -LSB- mmHg -RSB- = @ Body Mass Index -LSB- kg/m@ -RSB- +@ Diastolic Blood Pressure -LSB- mmHg -RSB- -@ Age -LSB- Years -RSB- -@ .


Estimated trans-lamina cribrosa pressure difference ( estTLCPD ) was IOP-estCSFP .


EstCSFP ( @ mmHg versus @ mmHg ; P = @ ) and estTLCPD ( @ mmHg versus @ mmHg ; P < @ ) were higher in the ocular hypertensive group than in the normotensive group .


In binary regression analysis , ocular hypertension was associated with increased estCSFP ( P = @ ; odds ratio ( OR ) : @ ; @ % confidence interval ( CI ) : @ , @ ) after adjusting for prevalence of arterial hypertension ( P = @ ; OR : @ ; @ % CI : @ , @ ) , retinal nerve fiber layer thickness ( P = @ ; OR : @ ; @ % CI : @ , @ ) and blood glucose concentration ( P = @ ; OR : @ ; @ % CI : @ , @ ) .


Ocular hypertensive subjects ( with IOP correction for CCT and corneal curvature ) as compared to ocular normotensive subjects had a significantly higher estCSFP in univariate analysis and in multivariate analysis .


Despite of a higher estCSFP , estTLCPD was still markedly higher in ocular hypertensive eyes than in ocular normotensive eyes .


Compare the effect of financial incentives on response to a cancer survivors ' postal questionnaire .


Prostate cancer survivors in Ireland , @-@ years after diagnosis , were randomized to the ( @ ) `` lottery '' arm -LSB- a @ lottery scratch card sent with the questionnaire ( n = @,@ ) -RSB- or ( @ ) `` prize '' arm -LSB- entry into a draw on return of a completed questionnaire ( n = @,@ ) -RSB- .


Impact of interventions on response overall and by survival period ( `` short term '' : < @ years after diagnosis ; `` long term '' : @ years after diagnosis ) was compared as was cost-effectiveness .


Adjusted response rate was @ % .


Response was higher among younger men ( P < @ ) and those with earlier stage disease ( P = @ ) .


A modest @ % higher response rate was observed in the lottery compared with the prize arm -LSB- multivariate relative risk ( RR ) = @ ; @ % confidence interval ( CI ) : @ , @ -RSB- .


When stratified by survival period , higher response in the lottery arm was only observed among long-term survivors ( multivariate RR = @ ; @ % CI : @ , @ ; short-term survivors : RR = @ ; @ % CI : @ , @ ) .


Costs per completed questionnaire were @ and @ for the lottery and prize arms , respectively .


Compared with the prize arm , cost per additional questionnaire returned in the lottery arm was @ .


Although more expensive , to optimize response to postal questionnaires among cancer survivors , researchers might consider inclusion of a lottery scratch card .


To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes .


This was a randomized , examiner-blind , parallel-group , two-treatment clinical trial of two weeks ' duration .


Subjects qualified for the study if they had an average Modified Lobene Stain Index of @ from two anterior teeth .


At baseline , subjects brushed in front of a mirror for one minute under supervision .


All subjects were provided with a standard @ % sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush ( OBP ) or a Colgate Whitening manual brush ( CW ) to use for two weeks .


Stain was reassessed after two weeks of product use .


Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index , which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index .


Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use .


Median stain reductions were @ % and @ % for the OBP and CW , respectively , as measured by the Modified Lobene Stain Index .


The mean changes in the composite scores from baseline to week two were @ and @ for the two treatment groups , respectively .


Statistically significant reductions from baseline were also found for the intensity and extent of stain measures ( p < @ ) .


Similar trends were found using the new Interproximal Modified Lobene Index .


Composite median stain removal percentages versus baseline were @ % and @ % for the OBP and CW groups , respectively ( p < @ ) .


For the interproximal sites , a median stain removal of @ % was observed with the OBP brush and @ % reduction with the CW brush .


For the gingival sites , the median stain removal percentages were @ % and @ % , respectively For the body region , a median stain removal of @ % was found for both treatment groups .


No statistically significant differences were found between the two groups for the mean composite scores for either index .


Both manual brushes showed effective stain removal , including interproximal hard-to-reach sites .


The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index , while allowing assessment of interproximal regions .


Patients undergoing both rigid and flexible cystoscopic evaluation suffer from a great deal of pain and discomfort .


In this study , we aimed to investigate the effect of lidocaine gel anestesia on patient comfort on diagnostic rigid cystoscopy .


@ mL of lubricant gel applied to each patient via the external meatus in @ s. Patients were randomized into three groups .


In group @ , liquid glycerine was applied and cystoscopy was immediately performed , in group @ lidocaine gel ( Aqua Touch : stem Tbbi Cihaz Ve Sanayi Ltd.ti , Ostim , Ankara , Trkiye ) was applied and the procedure undergone immediately and in group @ , lidocaine gel was applied and penis was clemped for @ minutes before the procedure .


VAS forms were filled to determine the discomfort and pain during cystoscopy and the first micturation after .


After the evaluation between groups , VAS scores were significantly lower in Group II and III than Group I and in Group III than in Group II ( p < @ ) .


When post micturation VAS scores were evaluated , VAS scores were significantly lower in Group II than Group I and in Group III than in Group II ( p < @ ) .


The application of local anesthetic lidocaine gel in rigid cystoscopy , is a practical , safe and efficient method to improve patient comfort when applied in appropriate dose and waiting duration .


For patients with clinically significant risk of febrile neutropenia , pegfilgrastim administration should occur the day after myelosuppressive chemotherapy ; however , a variety of factors may preclude patients from returning to the clinic the next day for pegfilgrastim administration , necessitating other strategies .


This study compared the pharmacokinetics and safety of pegfilgrastim administered via an on-body injector applied to the subject 's skin versus manual injection using a prefilled syringe .


Healthy subjects aged @-@years were randomized @:@ to receive a single @-mg subcutaneous pegfilgrastim dose from an on-body injector or a prefilled syringe .


Blood for pharmacokinetic measurements was collected at baseline and prespecified time points after pegfilgrastim administration ; safety was assessed throughout the @-week study .


Primary endpoints were maximum concentration ( C max ) and area under the concentration curve from time @ to infinity ( AUC@-inf ) .


Secondary endpoints included safety , tolerability , and immunogenicity .


Pegfilgrastim mean AUC@-inf values for the on-body injector ( n = @ ) and manual injection ( n = @ ) were @,@ and @,@ hng/mL , respectively ; mean C max values were @ and @ng/mL , respectively .


The least squares geometric mean ratios were @ for C max and @ for AUC@-inf ; the corresponding @ % CIs were within the prespecified range ( @-@ @ ) , indicating comparable pegfilgrastim pharmacokinetics between delivery methods .


Treatment-emergent adverse events ( AEs ) were similar between groups ( injector , @ % ; manual , @ % ) .


Injector - or syringe-related AEs were more prevalent with the injector ( @ % ; manual , @ % ) ; none were serious .


No pegfilgrastim-neutralizing antibodies were detected .


Pegfilgrastim pharmacokinetics and safety were comparable between the on-body injector and manual injection groups .


Although single , high doses of vitamin D effectively maintain vitamin D sufficiency in several populations , no studies have evaluated healthy adults over winter , during which vitamin D status declines .


This study investigated whether high-dose vitamin D@ given once to healthy adults before winter will ( @ ) prevent the wintertime decline in vitamin D status , ( @ ) promote vitamin D sufficiency @ year following the dose and ( @ ) prevent the rise of parathyroid hormone ( PTH ) concentrations .


In this double-blind , placebo-controlled trial , we assessed plasma @ ( OH ) D and PTH concentrations at baseline , @ , @ and @ days after drug administration in @ healthy adults .


In all , > @ % of subjects returned at each time point .


At baseline , the young , healthy participants had a mean plasma @ ( OH ) D concentration of @ ng/ml .


Only two subjects exhibited plasma @ ( OH ) D concentrations > @ng/ml .


At @ days , subjects randomized to vitamin D@ had a higher mean plasma @ ( OH ) D concentration compared with the placebo group ( @ vs @ ng/ml , P < @ ) .


Plasma @ ( OH ) D concentrations returned to baseline at @ and @ days in the vitamin D@ group and remained unchanged in the placebo group .


PTH and calcium concentrations were unrelated to changes in @ ( OH ) D levels and similar between groups over time .


A dose of @,@ IU of vitamin D@ given once in November resulted in a robust increase in plasma @ ( OH ) D after @ days , but it was unable to sustain this increase after @ days .


A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency .


We sought to determine the association of dietary factors and risk of cognitive decline in a population at high risk of cardiovascular disease .


Baseline dietary intake and measures of the Mini-Mental State Examination were recorded in @,@ men and women who were enrolled in @ international parallel trials of the ONTARGET ( Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial ) and TRANSCEND ( Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease ) studies .


We measured diet quality using the modified Alternative Healthy Eating Index .


Cox proportional hazards regression was used to determine the association between diet quality and risk of @-point decline in Mini-Mental State Examination score , and reported as hazard ratio with @ % confidence intervals with adjustment for covariates .


During @ months of follow-up , @,@ cases of cognitive decline occurred .


We observed lower risk of cognitive decline among those in the healthiest dietary quintile of modified Alternative Healthy Eating Index compared with lowest quintile ( hazard ratio @ , @ % confidence interval @-@ @ , Q@ vs Q@ ) .


Lower risk of cognitive decline was consistent regardless of baseline cognitive level .


We found that higher diet quality was associated with a reduced risk of cognitive decline .


Improved diet quality represents an important potential target for reducing the global burden of cognitive decline .


Insufficient data exist regarding postoperative thoracic epidural analgesia for morbidly obese patients undergoing open bariatric surgery .


This study evaluated the effectiveness of morphine loading in a postoperative thoracic epidural analgesic regimen of patient-controlled epidural analgesia ( PCEA ) with levobupivacaine combined with continuously administered epidural morphine in this patient group .


In this prospective randomized controlled trial , @ superobese patients ( body mass index of @ kg/m ( @ ) ) undergoing open bariatric surgery were randomly allocated to three groups of @ patients each .


Postoperatively , all groups received a continuous epidural morphine infusion of @ mg/h with @ % levobupivacaine via PCEA .


Group A did not receive intraoperative epidural morphine loading , while groups B and C received an intraoperative @ - and @-mg morphine bolus , respectively .


Levobupivacaine consumption via PCEA ( primary outcome ) , pain scores at rest and on cough , the time to return of bowel function and ambulation , and arterial blood gas levels ( secondary outcomes ) were recorded .


The increase in perioperative morphine administration ( groups B and C ) led to a significantly prolonged return to normal bowel function and delayed ambulation ( P < @ to @ , respectively ) , without an improvement in postoperative analgesia or a reduction in local anesthetic consumption .


Although the prevalence of obstructive sleep apnea ( OSA ) was high in all groups , no respiratory depression was observed .


Thoracic PCEA with @ % levobupivacaine combined with continuous epidural morphine administration of @ mg/h without morphine loading is an effective postoperative analgesic regimen that provides adequate pain control , early ambulation , and early return of bowel function in superobese patients , particularly those with OSA .


Anxiety is a prominent symptom in anorexia nervosa ( AN ) , and higher pre-meal anxiety has been associated with lower caloric intake .


Yet , the causal relationship has not been assessed .


We proposed that reducing anxiety with a short acting benzodiazepine would increase caloric intake among individuals with AN .


In a randomized , double-blind , placebo controlled cross-over study , we administered alprazolam @ mg to inpatients with AN ( n = @ ) and assessed caloric intake in a laboratory test meal .


Within-subject differences in caloric intake , anxiety , and fatigue were compared between alprazolam and placebo days .


Caloric intake did not differ on alprazolam versus placebo ( t ( @ ) = @ , p = @ ) .


Alprazolam did not reduce anxiety , but was associated with increased fatigue .


This study was not able to evaluate the causal role of anxiety in meal intake among individuals with AN , as alprazolam did not alter anxiety symptoms .


These data further suggest that the therapeutic role for short-acting benzodiazepines in AN is likely limited .


Elevating the torso in a Head Elevated Ramped Position during caesarean delivery benefits the mother by improving comfort and ventilation while reducing reflux symptoms and providing a better airway position .


We hypothesised that using an elevation pillow for an elective caesarean delivery under combined spinal-epidural anaesthesia would not significantly increase the time to achieve a T@ block .


Following ethical approval and informed consent , @ women undergoing elective caesarean delivery under combined spinal-epidural anaesthesia were randomised to one of three groups : Control - horizontal with a small pillow under the head ; Head Elevated Ramped Position - torso on an elevation pillow ; and Head Elevated Ramped Position with initial position horizontal .


Data collected were time to T@ , block height at @ and @ min , adequate block at @ min , need for epidural supplementation , maternal comfort and airway position assessment .


Time to T@ among the three groups was not significantly different ( P = @ ) .


However , there was a significant difference in achievement of block height of T@ at @ min and greater need for epidural supplementation in the intervention groups compared to the control group ( P = @ ) .


Non-inferiority analyses of time to T@ of both head elevated ramped positions were inconclusive about inferiority relative to the control .


Head Elevated Ramped Position was significantly more comfortable than control ( P = @ ) .


Using the level of the external auditory meatus to the sternal notch as an indicator for ease of laryngoscopy , Head Elevated Ramped Position provided a significantly better position than control ( P < @ ) .


Elevating the parturient undergoing elective caesarean delivery into the Head Elevated Ramped Position immediately or once the block had been established did not appear to significantly alter time to an adequate block height of T@ ; however , the need for epidural supplementation was greater in the intervention groups .


Cautious use of this novel position change can provide a more comfortable experience and provide a better airway position should conversion to general anaesthesia be required .


To observe the effect of pressing auricular points on myopia in children .


Myopic children aged @-@ years were divided into two groups .


The Chinese herb Semen Vaccariae was used to stimulate the auricular points of CO@ , LO@ , TF@ , CO@ , CO@ , and CO@ for three treatment courses for the experimental group ( n = @ ) , while the same therapy was not given to the control group ( n = @ ) .


Binocular naked vision of the experimental group and the control group before and after the intervention was measured using a standard E visual.acuity chart .


There was no difference in the binocular naked vision between the experimental group and the control group before the intervention .


In contrast , there was significant improvement in binocular naked vision in the experimental group after the intervention compared with the control group ( P < @ ) .


When combined with external medical application , non-invasive auricular therapy could improve the function of myopia in children .


Auricular pressing was well received by the children .


To study compliance to treatment and effectiveness of therapy in patients with axial spondyloarthritis ( ax-SpA ) in different observational regimes .


@ patients without TNF - therapy and BASDAI @ were randomized into @ groups .


@ of them were observed in a traditional manner , @ visited a rheumatologist every @ weeks , and @ were counseled by phone once in @ weeks .


In all these cases , rheumatologists collected data on the activity of the disease ( BASDAI , ASDAS , PASS , etc. ) and the effectiveness of therapy .


BASDAI in group @ was @ @ initially and @ @ one year after onset of the study , ASDAS @ @ and @ @ respectively ( p > @ ) .


In group @ , BASDAI values were @ @ and @ @ ; ASDAS @ @ and @ @ respectively .


In group @ , BASDAI values were @ @ and @ @ ; ASDAS @ @ and @ @ ; p < @ for the differences between initial and subsequent values in groups @ and @ and final values for all groups .


Positive PASS was reached in @ patients ( @ % , n = @ ) of group @ , in @ ones ( @ % , n = @ ) of group @ , and in @ ( @ % ) patients of group @ .


Five ( @ % ) , @ ( @ % ) and @ ( @ % ) patients in groups @ , @ and @ respectively wilfully ceased to take NSAID .


@ ( @ % ) , @ ( @ % ) and @ ( @ % ) patients of these groups stated that they needed hospitalization .


Telephone monitoring of ax-SpA activity once in every @ weeks revealed a better compliance with the treatment and results of therapy than active observation every @ weeks or arbitrary monitoring .


To test different forms of private insurance coverage as mediators for racial disparities in onset , persistent level , and acceleration of functional limitations among Medicare age-eligible Americans .


Data come from @ waves of the Health and Retirement Study ( @-@ ) .


Onset and progression latent growth models were used to estimate racial differences in onset , level , and growth of functional limitations among a sample of @,@ people aged @ and older in @ .


Employer-provided insurance , spousal insurance , and market insurance were next added to the model to test how differences in private insurance mediated the racial gap in physical limitations .


In baseline models , African Americans had larger persistent level of limitations over time .


Although employer-provided , spousal provided , and market insurances were directly associated with lower persistent levels of limitation , only differences in market insurance accounted for the racial disparities in persistent level of limitations .


Results suggest private insurance is important for reducing functional limitations , but market insurance is an important mediator of the persistently larger level of limitations observed among African Americans .


Ensuring adherence to treatment and retention is important in clinical trials , particularly in remote areas and minority groups .


We describe a novel approach to improve adherence , retention and clinical review rates of Indigenous children .


This descriptive study was nested within a placebo-controlled , randomised trial ( RCT ) on weekly azithromycin ( or placebo ) for @-weeks .


Indigenous children aged @-months hospitalised with acute bronchiolitis were recruited from two tertiary hospitals in northern Australia ( Darwin and Townsville ) .


Using mobile phones embedded within a culturally-sensitive approach and framework , we report our strategies used and results obtained .


Our main outcome measure was rates of adherence to medications , retention in the RCT and self-presentation ( with child ) to clinic for a clinical review on day-@ .


Of @ eligible children , @ ( @ % ) families declined participation and @ ( @ % ) did not have access to a mobile phone .


@ Indigenous children were randomised and received dose one under supervision in hospital .


Subsequently , @ ( @ % ) children received dose two ( day-@ ) , @ ( @ % ) dose three ( day-@ ) and @ ( @ % ) attended their clinical review ( day-@ ) .


A median of @ calls ( IQR @-@ ) were needed to verify adherence .


Importantly , over @ % of children remained in the RCT until their clinical endpoint at day-@ .


In our setting , the use of mobile phones within an Indigenous-appropriate framework has been an effective strategy to support a clinical trial involving Australian Indigenous children in urban and remote Australia .


Further research is required to explore other applications of this approach , including the impact on clinical outcomes .


CD@ + B cells have been conceptualized as a possible surrogate for Breg cells .


The aim of the present study was to determine the utility of CD@ + B cells as biomarkers in antineutrophil cytoplasmic antibody-associated vasculitis ( AAV ) .


The absolute and relative numbers ( percentages ) of CD@ + B cells ( explanatory variables ) were measured longitudinally during @ months in @ patients randomized to receive either rituximab ( RTX ) or cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) for the treatment of AAV ( Rituximab in ANCA-Associated Vasculitis -LSB- RAVE -RSB- trial ) .


Outcome variables included disease activity ( status of active disease versus complete remission ) , responsiveness to induction therapy , disease relapse , disease severity , and , in RTX-treated patients , relapse-free survival according to the percentage of CD@ + B cells detected upon B cell repopulation .


CD@ + B cell numbers were comparable between the treatment groups at baseline .


After an initial decline , absolute CD@ + B cell numbers progressively increased in patients in the RTX treatment arm , but remained low in CYC/AZA-treated patients .


In both groups , the percentage of CD@ + B cells increased during remission induction and slowly declined thereafter .


During relapse , the percentage of CD@ + B cells correlated inversely with disease activity in RTX-treated patients , but not in patients who received CYC/AZA .


No significant association was observed between the numbers of CD@ + B cells and induction treatment failure or disease severity .


The dynamics of the CD@ + B cell compartment did not anticipate disease relapse .


Following B cell repopulation , the percentage of CD@ + B cells was not predictive of time to flare in RTX-treated patients .


The percentage of peripheral CD@ + B cells might reflect disease activity in RTX-treated patients .


However , sole staining for CD@ as a putative surrogate marker for Breg cells did not identify a subpopulation of B cells with clear potential for meaningful clinical use .


Adequate phenotyping of Breg cells is required to further explore the value of these cells as biomarkers in AAV .


Hazelnut allergy in adults is often birch pollen related , whereas in children , non-pollen-related hazelnut allergy is more frequent .


To compare the differences in hazelnut allergy between children and adults with regard to severity , aetiology and diagnostic value of routinely available data .


Adults ( n = @ ) who underwent a double-blind placebo-controlled food challenge ( DBPCFC ) for hazelnut were selected and compared to @ hazelnut-challenged children from a previous study .


Univariate and multivariate logistic regression analyses were performed to build a prediction model .


The area under the curve ( AUC ) of the ROC curve was determined for level of hazelnut-specific IgE , skin prick test ( SPT ) and the prediction model .


Hazelnut allergy was confirmed by DBPCFC in @/@ ( @ % ) adults , @ % had only subjective and @ % objective symptoms , whereas in children , @ % had objective symptoms to hazelnut .


Within the group of children , the frequency of severe hazelnut allergy was higher in younger than in older children .


A concomitant birch pollen allergy was more common in adults ( @ % ) than in children ( @ % ) with a hazelnut allergy .


A detailed history with allergic symptoms to previous ingestion of hazelnut had the highest diagnostic value in adults , while in children , SPT to hazelnut extract showed the highest level of discrimination between clinical reactivity and tolerance to hazelnut .


Hazelnut allergy differs between children and adults with respect to frequency of severity , aetiology and relevance of diagnostic parameters .


Therefore , age has to be taken into account in the diagnostic work-up of a hazelnut allergy .


Assisted living ( AL ) residents are at risk for cognitive and functional declines that eventually reduce their ability to care for themselves , thereby triggering nursing home placement .


In developing a method to slow this decline , the efficacy of Reasoning Exercises in Assisted Living ( REAL ) , a cognitive training intervention that teaches everyday reasoning and problem-solving skills to AL residents , was tested .


At thirteen randomized Midwestern facilities , AL residents whose Mini Mental State Examination scores ranged from @-@ either were trained in REAL or a vitamin education attention control program or received no treatment at all .


For @ weeks , treated groups received personal training in their respective programs .


Scores on the Every Day Problems Test for Cognitively Challenged Elders ( EPCCE ) and on the Direct Assessment of Functional Status ( DAFS ) showed significant increases only for the REAL group .


For EPCCE , change from baseline immediately postintervention was +@ ( P < @ ) , and there was significant retention at the @-month follow-up ( d = @ ; P < @ ) .


For DAFS , change from baseline immediately postintervention was +@ ( P < @ ) , although retention was not as strong .


Neither the attention nor the no-treatment control groups had significant gains immediately postintervention or at follow-up assessments .


Post hoc across-group comparison of baseline change also highlights the benefits of REAL training .


For EPCCE , the magnitude of gain was significantly larger in the REAL group versus the no-treatment control group immediately postintervention ( d = @ ; P < @ ) and at the @-month follow-up ( d = @ ; P < @ ) .


For DAFS , gain magnitude immediately postintervention for REAL was significantly greater compared with in the attention control group ( d = @ ; P < @ ) .


REAL improves skills in everyday problem solving , which may allow AL residents to maintain self-care and extend AL residency .


This benefit is particularly important given the growing population of AL residents at risk for cognitive and self-care decline .


We sought to investigate the clinical relevance of neuroforaminal patency and facet degeneration one year after anterior cervical discectomy and fusion ( ACDF ) .


Previous studies were characterized by imprecise techniques and fragmentary measurements , and most lacked reliable clinical data and correlation analyses .


Patients with cervical mono - or bi-level degenerative pathology were prospectively included .


Neuroforaminal size and segmental height were determined quantitatively , and the degree of facet degeneration was assessed qualitatively before and one year after the operation , by computed tomography .


Clinical data , such as the severity of neck and arm pain , were assessed on a visual analogue scale ( VAS ) from @ to @ , and neck disability index ( NDI ) was recorded before and one year after the operation .


Their correlation with radiological data was investigated .


Seventy-nine patients aged @ years were included .


One year after surgery , median VAS pain intensity was still significantly improved ( neck , from @ to @ ; right arm , from @ to @ ; left arm , from @ to @ ) as was NDI ( from @ to @ ) .


Neuroforaminal size showed a reduction on both sides ( left , @ cm ( @ ) ; right , @ cm ( @ ) ) .


One year after the operation , segmental height decreased and facet degeneration increased from measures taken before the operation .


No correlations were found between neuroforaminal stenosis or the degree of facet degeneration and various clinical outcome parameters .


The decrease in segmental height one year after ACDF leads in turn to secondary neuroforaminal stenosis and progressive facet degeneration .


Of the various neuroforaminal variables used , none revealed a threshold value indicative of the presence or severity of radicular arm pain .


This absence of correlation between imaging and clinical information is important and should be considered when allocating patients for surgical interventions .


Inclusion in trials is selective , and thus results may not be generalizable to the general population .


The aim of this study was to investigate the external validity of randomized clinical trial outcomes for elderly breast cancer patients .


We compared characteristics and outcomes of breast cancer patients ( n = @ ) who participated in a randomized clinical trial ( Tamoxifen Exemestane Adjuvant Multinational trial ) with unselected breast cancer patients of corresponding age from the general population ( n = @ ) .


Dutch patients aged @ years or older at diagnosis of hormone receptor-positive breast cancer without distant metastases , with either nodal involvement , a tumor greater than @cm , or a @ to @cm histological grade III tumor , who completed local therapy were included .


Analyses were stratified by age ( @-@ years ; @ years ) .


Primary outcome was overall mortality .


Multivariable Cox proportional hazards models were used to assess the association between covariables and overall mortality .


All statistical tests were two-sided .


Irrespective of age , patients who participated in the trial had fewer comorbid diseases , a higher socioeconomic status , and smaller tumors ( all P < @ ) .


In patients aged @ to @ years , those who participated in the trial had a similar overall mortality to patients from the general population ( multivariable hazard ratio -LSB- HR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ to @ ) .


Alternatively , in patients aged @ years or older , those who participated in the trial had a lower overall mortality ( multivariable HR = @ ; @ % CI = @ to @ ; P = @ ) than patients in the general population .


Breast cancer trial participants aged @ years or older do not represent elderly breast cancer patients of corresponding age from the general population , which hampers the external validity of a trial .


We previously developed and piloted a telephone-based intimacy enhancement ( IE ) intervention addressing sexual concerns of colorectal cancer patients and their partners in an uncontrolled study .


The current study tested the feasibility , acceptability , and preliminary efficacy of the IE intervention in a randomized , controlled trial .


Twenty-three couples were randomized to either the four-session IE condition or to a wait list control condition and completed sexual and relationship outcomes measures .


The IE intervention teaches skills for coping with sexual concerns and improving intimacy .


Feasibility and acceptability were assessed through enrollment and post-treatment program evaluations , respectively .


Effect sizes were calculated by comparing differences in average pre/post change scores across completers in the two groups ( n = @ couples ) .


Recruitment and attrition data supported feasibility .


Program evaluations for process ( e.g. , ease of participation ) and content ( e.g. , relevance ) demonstrated acceptability .


Engaging in intimacy-building activities and communication were the skills rated as most commonly practiced and most helpful .


For patients , positive effects of the IE intervention were found for female and male sexual function , medical impact on sexual function , and self-efficacy for enjoying intimacy ( @ ) ; no effects were found on sexual distress or intimacy and small negative effects for sexual communication , and two self-efficacy items .


For partners , positive IE effects were found for all outcomes ; the largest were for sexual distress ( @ ) , male sexual function ( @ ) , communication ( @ ) , and two self-efficacy items ( @ ) .


The telephone-based IE intervention shows promise for couples facing colorectal cancer .


Larger multi-site intervention studies are necessary to replicate findings .


Mobility assessment in Multiple Sclerosis ( MS ) is crucial for trials and individual patient counseling .


Up to now , standard tests as the Timed @-Foot Walk ( T@FW ) are restricted by floor effects in mildly disabled patients .


The @-meter Timed Tandem Walk ( TTW ) as a possibly more sensitive measure has not been investigated yet .


To investigate sensitivity and specificity of the TTW and T@FW to detect mild clinical impairment in a large cohort of MS patients .


We extracted T@FW , TTW and EDSS from our UMC patient database ( @-@ ) .


After randomization into an explorative ( n = @ ) and validation ( n = @ ) cohort , we calculated change rates and performed ROC analyses of gait tests and EDSS including Functional System Scores .


Between disability stages of EDSS @-@ @ and EDSS @-@ @ , the mean TTW difference was @s ( T@FW = @ s ) .


The accuracy to separate between EDSS groups was moderate but identical for both tests ( ROC-AUC T@FW = @ , TTW = @ , p = @ ) .


TTW had a higher sensitivity and specificity to differentiate between asymptomatic and symptomatic patients concerning FS motor/cerebellar scores ( ROC-AUC T@FW = @ , TTW = @ , p < @ ) .


All hypotheses could be validated in the second cohort .


A @-m Timed Tandem Walk is a standardized test that is easy to implement to detect impairment of the motor or cerebellar system in fully ambulatory MS patients .


Based on the complex-task character , TTW is a potential new outcome measure for MS mobility in mildly disabled patients and can act as easily accessible and significant additional information in patient counseling .


To examine the effect of a @-time dose of pregabalin ( Lyrica ) on the perception of pain and analgesic consumption after oculofacial plastic surgery .


In this prospective , randomized , double-blind , placebo-controlled trial , patients presenting to the oculofacial plastic surgery service at University of Colorado Eye Center for functional eyelid surgery and who met the study criteria were consecutively enrolled between October @ and September @ .


Subjects were randomized to either placebo or @ mg pregabalin administered @ minutes to an hour prior to the procedure .


The procedure was then performed under the usual standard of care .


Postoperatively , study subjects recorded pain scores on visual analog scales ( range @-@ ) at @ to @ hours , @ to @ hours , @ to @ hours , @ to @ hours , and @ to @ hours and the amount of acetaminophen consumed .


Data were analyzed with Statistical Analysis System software using mixed-effects linear models .


Fifty-two patients were enrolled .


Three patients were excluded due to incomplete follow up ( n = @ ) and postoperative course requiring early unblinding ( n = @ ) .


Twenty-six subjects were men .


Average age was @ years ( range , @-@ ) .


Eyelid procedures performed included blepharoplasty ( @ ) , canthoplasty ( @ ) , ptosis repair ( @ ) , eyelid retraction repair ( @ ) , pentagonal wedge resection ( @ ) , and MOHS reconstruction ( @ ) .


Twenty-six patients were randomized to receive pregabalin , while the remainder received placebo .


There was no significant difference in demographics between the @ groups .


The pregabalin group reported pain scores that were @ points lower on average compared with the placebo group ( p = @ ) .


Patients in the pregabalin group also consumed half as much acetaminophen ( @ g ) on average as the placebo group ( @ g ) during the postoperative period .


Pregabalin is effective in reducing postoperative pain after oculoplastic procedures when compared with placebo .


It may be a useful adjunct for pain control in selected patients .


Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia .


To further study the chemopreventive potential of these nutrients , we conducted a randomized , double-blind , placebo-controlled trial of supplementation with vitamin D , calcium , or both for the prevention of colorectal adenomas .


We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy .


We randomly assigned @ participants to receive daily vitamin D@ ( @ IU ) , calcium as carbonate ( @ mg ) , both , or neither in a partial @ factorial design .


Women could elect to receive calcium plus random assignment to vitamin D or placebo .


Follow-up colonoscopy was anticipated to be performed @ or @ years after the baseline examinations , according to the endoscopist 's recommendation .


The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy .


Participants who were randomly assigned to receive vitamin D had a mean net increase in serum @-hydroxyvitamin D levels of @ ng per milliliter , relative to participants given placebo .


Overall , @ % of participants had one or more adenomas diagnosed during follow-up .


The adjusted risk ratios for recurrent adenomas were @ ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) with vitamin D versus no vitamin D , @ ( @ % CI , @ to @ ) with calcium versus no calcium , and @ ( @ % CI , @ to @ ) with both agents versus neither agent .


The findings for advanced adenomas were similar .


There were few serious adverse events .


Daily supplementation with vitamin D@ ( @ IU ) , calcium ( @ mg ) , or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of @ to @ years .


( Funded by the National Cancer Institute ; ClinicalTrials.gov number , NCT@ . )


To investigate the effectivity of pentoxifylline ( PTX ) and immunoglobulin M ( IgM ) - enriched intravenous immunoglobulin ( IVIG ) therapy in the treatment of neonatal sepsis ( NS ) , alone or in combination .


This was a prospective , double-blind , controlled study .


Newborns with suspicion of sepsis were enrolled in the study .


The patients were separated into four groups according to treatment protocol : Group @ = placebo , Group @ = pentoxifylline , Group @ = IgM-enriched IVIG , and Group @ = pentoxifylline + IgM-enriched IVIG .


Blood samples were taken for C-reactive protein , interleukin-@ , neutrophil CD@ expression , and tumor necrosis factor-alfa measurements immediately before treatment ( @st day ) , and measurements were repeated on the @nd and @th days of the therapy .


A total of @ patients , @ in each group , were recruited into the study .


There were no significant differences for symptoms of sepsis among groups , except lethargy .


No significant differences were observed among the groups according to laboratory data .


Overall mortality rate was @ % .


The rates of morbidities and mortality among study groups were similar .


PTX and IgM-enriched IVIG therapies , either alone or in combination , did not reduce the rates of morbidities and mortality in NS .


The objective of this randomized , examiner-blind , parallel , controlled clinical study was to compare the antiplaque/antigingivitis efficacy of an essential oil-containing mouthrinse ( EO ) to a new @ % cetylpyridinium chloride mouthrinse ( CPC ) using a two-week experimental gingivitis model with a @ % hydroalcohol rinse serving as the negative control .


After signing informed consents and completing baseline examinations , @ subjects were randomized into three groups .


Subjects began supervised/recorded rinsing with @ ml of their assigned rinse for @ seconds twice daily for two weeks , with no mechanical oral hygiene permitted .


Baseline and two-week assessments were conducted as follows : Turesky Modification of the Quigley-Hein Plaque Index ( PI ) , Modified Gingival Index ( MGI ) , and the Gingival Bleeding Index ( BI ) .


Analysis of efficacy variables ( i.e. , mean PI , mean MGI , mean BI , and proportion of bleeding sites derived from the BI ) was performed using a one-way analysis of covariance ( ANCOVA ) .


Among the @ subjects who completed the study , the EO rinse showed statistically significant reductions compared to the negative control within the range previously reported in this model ; PI = @ % ( p < @ ) and MGI = @ % ( p < @ ) .


A @ % reduction in proportion of bleeding sites ( p < @ ) was demonstrated .


Mean PI , MGI , and proportion of bleeding sites at two weeks were statistically significantly lower for the EO rinse compared to the CPC rinse ( p < @ ) , showing @ % , @ % , and @ % reductions , respectively .


An EO rinse provided superior antigingivitis/antiplaque efficacy compared to a @ % CPC rinse in this short-term clinical trial , and demonstrated efficacy within the range shown in previous studies using this model .


Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China .


However , its efficacy and cost comparing with mammography has not been evaluated in randomised trials .


At @ breast centres across China during @-@ , @ high-risk women aged @-@ years were randomised to be screened by mammography alone , ultrasound alone , or by both methods at enrollment and @-year follow-up .


A total of @ and @ women underwent the initial and second screenings , respectively .


Among the @ cancers ( of which @ were stage @/I ) detected , @ ( @ / @ ) were in the mammography group , @ ( @ / @ ) in the ultrasound group , and @ ( @ / @ ) in the combined group ( P = @ ) .


In the combined group , ultrasound detected all the @ cancers , whereas mammography detected @ , making ultrasound more sensitive ( @ vs @ % , P = @ ) with a better diagnostic accuracy ( @ vs @ , P = @ ) .


There was no difference between mammography and ultrasound in specificity ( @ vs @ % , P = @ ) and positive predictive value ( @ vs @ % ; P = @ ) .


To detect one cancer , the costs of ultrasound , mammography , and combined modality were $ @ , $ @ , and $ @ , respectively .


Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women .


To investigate the effects of the pre-emptive local infiltration of dexamethasone vs. levobupivacaine on postoperative pain and morbidity in pediatric adenotonsillectomy patients .


A total of @ patients ( @ males and @ females ) , aged @-@ years , were included in this double-blind prospective randomized controlled clinical study from September of @ until May of @ .


Patients admitted for adenotonsillectomies after informed consent was obtained from the parents , and randomized into three groups receiving either dexamethasone sodium phosphate ( Group @ , mean age @ @ ) , levobupivacaine with epinephrine ( Group @ , mean age @ @ ) , or saline ( Group @ , mean age @ @ ) .


Pain scores at the @st , @th , @th , @th , @th , and @th hours , and first , second , third and seventh days post-operatively were recorded by the parents using McGrath 's face scale .


The operation type , operation time and anesthesia time , the time of the first request for postoperative analgesia , and the total number of analgesic interventions were recorded .


Pain scores were revealed in this order : Group @ ( steroid ) < Group @ ( levobupivacaine ) < Group @ ( saline ) at all times ( p = @ ) .


The anesthesia times for Group @ and Group @ were different ( steroid vs. levobupivacaine ) , and the time to first analgesic was longer in Groups @ ( steroid ) and @ ( levobupivacaine ) than in Group @ ( saline ) ( p < @ ) .


The total number of analgesic interventions was lower in Group @ ( steroid ) than in Group @ ( levobupivacaine ) and Group @ ( saline ) ( steroid vs. saline , p = @ , and steroid vs. levobupivacaine , p < @ ) .


Peritonsillar dexamethasone infiltration was more effective than both levobupivacaine and saline in reducing post-tonsillectomy pain .


It was proven to be a safe and effective method .


A safe , effective vaccine for breastfeeding infants born to HIV-@-positive mothers could complement antiretroviral therapy ( ART ) for prevention of mother-to-child transmission of HIV-@ .


To date , only a few HIV-@ vaccine candidates have been tested in infants .


A phase I/II randomized controlled trial PedVacc @ was conducted to determine the safety and immunogenicity of a single , low dose of MVA.HIVA vaccine delivered intramuscularly to healthy @-week-old infants born to HIV-@-positive mothers in Nairobi , Kenya .


Pregnant HIV-@-positive women in the @nd/@rd trimester of gestation were enrolled , provided with ART and self-selected their infant-feeding modality .


Infants received nevirapine and cotrimoxazole prophylaxis .


At @ weeks of age , eligible HIV-@-negative infants were randomized to vaccine versus no-treatment arms and followed to @ weeks of age for assessments of vaccine safety , HIV-@-specific T-cell responses and antibodies to routine childhood vaccines .


Between February and November @ , @ mothers were screened , @ were eligible and followed on ART during pregnancy/postpartum , of whom @ had eligible infants at @ weeks postpartum .


Thirty-six infants were randomized to vaccine and @ to no treatment .


Eighty-four percent of infants breastfed , and retention at @ weeks was @ % .


Adverse events were rare and similar between the two arms .


HIV-@-specific T-cell frequencies in interferon - ELISPOT assay were transiently higher in the MVA.HIVA arm ( p = @ ) , but not above the threshold for a positive assay .


Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV , where @ % of MVA.HIVA subjects compared to @ % of control subjects were protected ( p = @ ) .


This trial tested for the first time an MVA-vectored candidate HIV-@ vaccine in HIV-@-exposed infants in Africa , demonstrating trial feasibility and vaccine safety , low immunogenicity , and compatibility with routine childhood vaccinations .


These results are reassuring for use of the MVA vector in more potent prime-boost regimens .


To evaluate the effects of @ % levobupivacaine at @ C preheated from room temperature , on sensorial block , motor block , and haemodynamics in patients undergoing transurethral prostate resection ( TUR-P ) .


The patients were randomly allocated to two groups : Group I patients were injected with @ mL @ % levobupivacaine solution which had been kept at room temperature for at least @ hours and Group II patients were injected with @ mL @ % levobupivacaine solution which had been kept at @ C for at least @ hours .


The patients were examined in terms of sensorial block , motor block , haemodynamic profile , and incidence of side effects .


No significant difference was found between the groups in terms of demographic data .


The time to reach T @ sensory block and the time of starting motor block were found to be significantly shorter in Group II .


The duration of sensory block over T @ and T @ , the duration of L @ regression , the duration of the sensory block , and the regression time of the motor blocks from @ to @ were found to be longer in Group II .


The use of @ % levobupivacaine spinal anaesthesia heated to @ C accelerated the start of sensory and motor block .


The complexity of pain after laparoscopic cholecystectomy ( LC ) needs multi-module analgesia .


Opioids are widely used for perioperative pain but associated with numerous adverse effects .


We investigated the effect of parecoxib administrated preoperatively and postoperatively for analgesia after ambulatory laparoscopic cholecystectomy .


@ patients scheduled for ambulatory LC with general anesthesia were randomly assigned to three groups : group A received @ mg parecoxib injection @-@ min before anesthesia induction and @ ml saline injection when gallbladder was removed ; group B received @ ml saline injection @-@ min before anesthesia induction and @ mg parecoxib injection when gallbladder was removed ; group C received @ ml saline injection @-@ min before anesthesia induction and the time when gallbladder was removed .


We recorded the time achieve to modified Aldrete 's score > @ in the post-anesthesia care unit ( PACU ) and modified Post-Anesthetic Discharge Scoring System ( PADSS ) > @ in ambulatory unit .


The visual analog scale ( VAS ) was used to assess the degree of the postoperative pain in the first @ h , and the numbers of patients who need additional analgesic and postoperative adverse effects were also recorded .


Patients of group A had a shorter length of stay ( LOS ) in PACU compared to these of group B and group C ( @ @ min vs. @ @ min and @ @ min , P < @ ) .


Patients of group A also had a shorter discharge time compared to these of group B and group C ( @ @ min vs. @ @ min and @ @ min , P < @ ) .


Moreover , patients of group A experienced reduced pain intensity , less postoperative side effect , and less additional analgesic requirement .


Preoperative administration of parecoxib for postoperative analgesia provided significant effect on reducing PACU length of stay ( LOS ) and discharge time , and improving patient outcome after ambulatory LC .


Hyperglycemia is a marker of poor prognosis in severe brain injuries .


There is currently little data regarding the effects of intensive insulin therapy ( IIT ) on neurological recovery .


A sub-group analysis of the randomized-controlled CGAO-REA study ( NCT@ ) in surgical intensive care units ( ICU ) of two university hospitals .


Patients with severe brain injury , with an expected ICU length of stay @ hours were included .


Patients were randomized between a conventional glucose management group ( blood glucose target between @ and @ mmol.L ( -@ ) ) and an IIT group ( blood glucose target between @ and @ mmol.L ( -@ ) ) .


The primary outcome was the day-@ neurological outcome evaluated with the Glasgow outcome scale .


A total of @ patients were included in this analysis .


In total @ ( @ % ) patients were randomized in the control group and @ ( @ % ) in the IIT group .


The mean Glasgow coma score at baseline was @ ( @ ) .


Patients in the IIT group received more insulin ( @ ( @ to @ ) IU versus @ ( @ to @ ) IU in the control group , P = @ ) , had a significantly lower morning blood glucose level ( @ ( @ to @ ) mmol.L ( -@ ) versus @ ( @ to @ ) mmol.L ( -@ ) , P < @ ) in the first @ days after ICU admission .


The IIT group experienced more episodes of hypoglycemia ( P < @ ) .


In the IIT group @ ( @ % ) patients had a favorable neurological outcome ( good recovery or moderate disability ) compared to @ ( @ % ) in the control group ( P = @ ) .


There were no differences in day-@ mortality .


The occurrence of hypoglycemia did not influence the outcome .


In this sub-group analysis of a large multicenter randomized trial , IIT did not appear to alter the day-@ neurological outcome or ICU morbidity in severe brain injured patients or ICU morbidity .


Patients with Alzheimer 's disease ( AD ) exhibit significantly less macular pigment ( MP ) and poorer vision when compared to control subjects .


To investigate supplementation with the macular carotenoids on MP , vision , and cognitive function in patients with AD versus controls .


A randomized , double-blind clinical trial with placebo and active arms .


@ AD patients and @ age-similar control subjects were supplemented for six months with either Macushield ( @ mg meso-zeaxanthin -LSB- MZ -RSB- ; @ mg lutein -LSB- L -RSB- ; @ mg zeaxanthin -LSB- Z -RSB- ) or placebo ( sunflower oil ) .


MP was measured using dual-wavelength autofluorescence ( Heidelberg Spectralis ) .


Serum L , Z , and MZ were quantified by high performance liquid chromatography .


Visual function was assessed by best corrected visual acuity and contrast sensitivity ( CS ) .


Cognitive function was assessed using a battery of cognition tests , including the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) ) .


Subjects on the active supplement ( for both AD and non-AD controls ) exhibited statistically significant improvement in serum concentrations of L , Z , MZ , and MP ( p < @ , for all ) and also CS at ( p = @ ) .


Also , for subjects on the active supplement , paired samples t-tests exhibited four significant results ( from five spatial frequencies tested ) in the AD group , and two for the non-AD group , and all indicating improvements in CS .


We found no significant changes in any of the cognitive function outcome variables measured ( p > @ , for all ) .


Supplementation with the macular carotenoids ( MZ , Z , and L ) benefits patients with AD , in terms of clinically meaningful improvements in visual function and in terms of MP augmentation .


Limited data exist on cotrimoxazole prophylactic treatment ( CPT ) in pregnant women , including protection against malaria versus standard intermittent preventive therapy with sulfadoxine-pyrimethamine ( IPTp ) .


Using observational data we examined the effect of CPT in HIV-infected pregnant women on malaria during pregnancy , low birth weight and preterm birth using proportional hazards , logistic , and log binomial regression , respectively .


We used linear regression to assess effect of CPT on CD@ count .


Data from @ CPT-exposed and @ CPT-unexposed women were analyzed .


CPT was associated with protection against malaria versus IPTp ( hazard ratio : @ , @ % Confidence Interval ( CI ) : @ , @ ) .


After adjustment for time period this effect was not statistically significant ( adjusted hazard ratio : @ , @ % CI : @ , @ ) .


Among women receiving and not receiving CPT , rates of low birth weight ( @ % versus @ % ) and preterm birth ( @ % versus @ % ) were similar .


CPT was associated with lower CD@ counts @ weeks postpartum in women receiving ( -@ cells / L , @ % CI : -@ , -@ ) and not receiving antiretrovirals ( -@ cells / L , @ % CI : -@ , -@ ) .


Compared to IPTp , CPT provided comparable protection against malaria in HIV-infected pregnant women and against preterm birth or low birth weight .


Possible implications of CPT-associated lower CD@ postpartum warrant further examination .


Diet might influence progression of hypertrophic cardiomyopathy ( HCM ) .


To investigate whether diet composition could alter clinical , biochemical , or echocardiographic variables in cats with HCM .


Twenty-nine cats with HCM ( International Small Animal Cardiac Health Council stage @b ) examined at a university teaching hospital .


Randomized , placebo-controlled trial .


After physical examination , echocardiogram , and blood collection , cats were randomized to @ of @ diets , which varied in carbohydrate and fat content and ingredients .


Measurements were repeated after @ months .


There were no significant differences among the @ groups at baseline .


After @ months , there were no significant changes in the primary endpoints , left ventricular free wall ( Group A , P = @ ; Group B , P = @ ; Group C , P = @ ) or interventricular septal thickness in diastole ( Group A , P = @ ; Group B , P = @ ; Group C , P = @ ) .


Group A had significant increases in BUN ( P = @ ) and cholesterol ( P = @ ) , while Group B had significant increases in BUN ( P = @ ) , cholesterol ( P = @ ) , and triglycerides ( P = @ ) , and significant decreases in NT-proBNP ( P = @ ) and hs-troponin I ( P = @ ) .


Group C had significant decreases in body weight ( P = @ ) , left atrial dimension ( P = @ ) , interventricular septal thickness in systole ( P = @ ) , and liver enzymes ( P = @ -@ ) .


These data suggest that diet might influence some clinical , biochemical , and echocardiographic variables in cats with HCM .


The purpose of this clinical investigation was to evaluate long-term results obtained with the combination of platelet pellet ( PP ) plus bioabsorbable barrier membrane ( BM ) and to compare this outcome with the results obtained using bioactive glass ( BG ) graft material with a BM .


Using a split mouth design , @ chronic periodontitis patients ( power at least @ % ) were randomly assigned to treatment with a combination of PP/GTR or BG/GTR in contra-lateral dentition areas .


Clinical attachment level ( CAL ) as the primary outcome variable , calculated as the sum of probing pocket depth ( PPD ) and gingival recession , and radiological alveolar bone level were recorded at baseline , @ months and @ years .


There were no statistical differences between test and control defects at baseline .


PPD reductions and CAL and radiological alveolar bone height gains were statistically significant between baseline and @ months and between baseline and @ years in both groups ( p < @ ) .


Six months results of frequency distribution showed that @ % of the defects attained @ mm CAL gain in both groups , while @ year results showed that @ % of the defects attained @ mm CAL gain < @ mm in the PP/BM group and @ % of the defects attained @ mm CAL gain < @ mm in the BG/BM group .


All parameters evaluated showed no significant differences between @ months and @ years in both groups ( p > @ ) .


No statistically significant difference in any of the clinical parameters was observed at @ months and @ years between the groups ( p > @ ) .


The long-term efficacy of platelet concentrate combined with a barrier membrane is similar with the combination of bioactive glass graft material and barrier membrane , suggesting that results obtained with both treatment approaches can be maintained over a period of @ years .


Endothelin-@ contributes to endothelial dysfunction in patients with atherosclerosis and type @ diabetes .


In healthy arteries the ETA receptor mediates the main part of the vasoconstriction induced by endothelin-@ whilst the ETB receptor mediates vasodilatation .


The ETB receptor expression is upregulated on vascular smooth muscle cells in atherosclerosis and may contribute to the increased vasoconstrictor tone and endothelial dysfunction observed in this condition .


Due to these opposing effects of the ETB receptor it remains unclear whether ETB blockade together with ETA blockade may be detrimental or beneficial .


The aim was therefore to compare the effects of selective ETA and dual ETA/ETB blockade on endothelial function in patients with type @ diabetes and coronary artery disease .


Forearm endothelium-dependent and endothelium-independent vasodilatation was assessed by venous occlusion plethysmography in @ patients before and after selective ETA or dual ETA/ETB receptor blockade .


Dual ETA/ETB receptor blockade increased baseline forearm blood flow by @ % ( P < @ ) whereas selective ETA blockade did not ( @ % ) .


Both selective ETA blockade and dual ETA/ETB blockade significantly improved endothelium-dependent vasodilatation .


The improvement did not differ between the two treatments .


There was also an increase in endothelium-independent vasodilatation with both treatments .


Dual ETA/ETB blockade did not significantly increase microvascular flow but improved transcutaneous pO@ .


Both selective ETA and dual ETA/ETB improve endothelium-dependent vasodilatation in patients with type @ diabetes and coronary artery disease .


ETB blockade increases basal blood flow but does not additionally improve endothelium-dependent vasodilatation .


Human skin aging is a multifactorial and complex biological process affecting the different skin constituents .


Even if the skin aging mechanism is not yet fully unravelled is evident that epidermis loses the principal molecule responsible for binding and retaining water molecules , resulting in loss of skin moisture and accounting for some of the most striking alterations of the aged skin .


This Study investigated the cosmetic filling efficacy of Fillerina in decreasing the skin aging signs and in improving facial volume deficiencies .


A placebo-controlled , double-blind , randomized clinical trial was carried out on @ healthy female subjects showing mild to moderate clinical signs of skin aging .


The effect of the treatment on skin surface and on face volumes was assessed both in the short-term ( @ h after a single product application ) and in the long-term ( @ , @ , and @ days after continuative daily use ) .


Three hours after a single application and after @ , @ , and @ days of treatment the lips volume was increased by @ % , @ % , @ % , and @ % .


After @ , @ , and @ days : ( @ ) skin sagging of the face contours was decreased by -@ @ , -@ @ , and -@ @ mm , respectively ; ( @ ) skin sagging of the cheekbones contours was decreased by -@ @ , -@ @ , and -@ @ mm , respectively ; ( @ ) cheekbones volume was increased by @ @ , @ @ , and @ @ mm , respectively ; ( @ ) wrinkle volume was decreased by -@ % , -@ % , and -@ % , respectively ; and ( @ ) wrinkle depth was decreased by -@ % , -@ % , and -@ % respectively .


This study demonstrated the positive filling effect of Fillerina in decreasing the clinical signs of skin aging and in improving the face volumes .


To examine bowel wall edema development in laparoscopic and open major visceral surgery .


In a prospective study , @ consecutively operated patients with gastric and pancreatic resections were included .


Twenty-seven patients were operated in a conventional open procedure ( open group ) and @ in a laparoscopic fashion ( lap group ) .


In all procedures , a small jejunal segment was resected during standard preparation , of which we measured the dry-wet ratio .


Furthermore , HE staining was performed for measuring of bowel wall thickness and edema assessment .


Mean value ( std ) of dry-wet ratio was significantly lower in the open than in the lap group ( @ versus @ ; p = @ ) with the same amount of fluid administration in both groups and a longer infusion interval during laparoscopic surgery .


Subgroup analyses ( only pancreatic resections ) still showed similar results .


Histologic examination depicted a significantly larger bowel wall thickness in the open group .


Laparoscopic surgery does not seem to lead to the bowel wall edema observed to occur in open surgery regardless of the degree of intravenous fluid administration , thus supporting its use even in major visceral surgery .


Testing the ability to program IVF GnRH-antagonist cycles to avoid weekend oocyte retrieval .


Preliminary randomized clinical trial .


Patients presenting an indication for IVF or IVF-ICSI were assigned into either the Treatment Group - GnRH antagonist protocol , programmed to start stimulatory agents on a Friday , with oral @mg estradiol valerate twice a day from the @nd day of cycle until the first Friday to follow , or to the Control Group - long luteal GnRH agonist protocol .


The performance of @ Treatment Group patients and @ Control Group patients was analyzed .


Cycle dynamics were not clinically or statistically different except for a significant difference in the number of follicles measuring @ mm on hCG administration day .


There were no differences in the number of aspirated ova , fertilization rates , embryo quality or number of embryos to be transferred .


Pregnancy rate was @ % in the Treatment Group and @ % in the Control Group ( P > @ ) .


Only one patient assigned to the Treatment Group had a weekend retrieval .


Preliminary results demonstrate no compromise related to follicular estrogen programming in a GnRH antagonist protocol and provide reassurance regarding the ability to achieve programming goals .


Intimate partner violence ( IPV ) victimization is a prevalent issue among women residing in Mexico City .


Comprehensive and integrated health care provider ( HCP ) delivered programs in clinic-settings are needed , yet few have been evaluated in Latin America , including Mexico .


In addition , there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics .


The current randomized controlled trial seeks to increase midlevel HCPs ' capacity , specifically nurses , who are often the first point of contact in this setting , to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation .


Specific outcomes include changes in past-year IPV ( physical and/or sexual ) , reproductive coercion , safety planning , use of community resources , and quality of life .


Forty-two public health clinics in Mexico City were randomized to treatment or control clinics .


Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV , providing supportive referrals , and assessing for health and safety risks .


Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women .


Women were screened for eligibility ( currently experiencing abuse in a heterosexual relationship , @-@ years of age , non-pregnant or in first trimester ) by research assistants in private areas of waiting rooms in health clinics .


Consenting women completed a baseline survey and received the study protocol for that clinic .


In treatment clinics , women received the nurse delivered session at baseline and received a follow-up counseling session after three months .


Surveys are conducted at baseline , three months , and fifteen months from baseline .


This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context .


Findings can be used to inform IPV programs and policies in Mexico City 's public health clinics .


Japanese encephalitis ( JE ) is the most important cause of viral encephalitis in Asia .


In this randomized , open-label , multicenter trial in @ children aged @ to @ months in Taiwan , children received one dose of JE-CV and one dose of MMR vaccine .


Vaccines were either administered separately @ weeks apart ( Groups ` JE-CV ' and ` MMR ' , named after which vaccine was given first ) , or concomitantly ( Group ` Co-Ad ' ) .


JE neutralizing antibody titers were assessed using PRNT@ .


MMR antibody levels were determined by ELISA .


All groups had low seroprotection/seropositivity rates ( < @ % ) before vaccination for all antigens .


Forty two days after vaccination , on either Study Day @ or @ , seroconversion rates for all antigens were high in all groups , irrespective of the order of vaccinations .


Seroconversion for JE ranged from @ % in Group Co-Ad on D@ to @ % in Group MMR .


Non-inferiority was demonstrated for all analyses as the lower bound of the @ % CI of the difference in seroconversion rates between groups was above the pre-defined limit of -@ % .


The immune responses remained high for all antigens and well above the level of protection @ months after vaccination in all groups .


There were no safety concerns .


JE-CV is safe and induces a strong protective immune response which persists over @ year when co-administered with MMR vaccine .


Inguinal hernia is one of the most common diseases in the elderly .


Treatment of this pathology is exclusively surgical and relies almost always on the use of local anesthesia .


While in the past hernia surgery was carried out mainly by general anesthesia , in recent years there has been growing emphasis on the role of local anesthesia .


The aim of our study was to compare intra-and postoperative analgesia obtained by the use of levobupivacaine to the same obtained by bupivacaine .


Bupivacaine is one of the main local anesthetics used in the intervention of inguinal hernioplasty .


Levobupivacaine is an enantiomer of racemic bupivacaine with less cardiotoxicity and neurotoxicity .


The study was conducted from March @ to March @ .


We collected data of eighty patients , male and female , aged between @ and @ years , who underwent inguinal hernioplasty with local anesthesia .


Evaluation of intra-operatively pain shows that minimal pain is the same in both groups .


Mild pain was more frequent in the group who used levobupivacaine .


Moderate pain was slightly more frequent in the group who used bupivacaine .


Only one reported intense pain .


Two drugs seem to have the same effect at a distance of six , twelve , eighteen and twentyfour hours .


Bupivacaine shows a significantly higher number of complications , as already demonstrated by previous studies .


Degree of satisfaction expressed by patients has been the same in the two groups .


Levobupivacaine group has shown a greater request for paracetamol while patients who experienced bupivacaine have showed a higher request of other analgesics .


Clinical efficacy of levobupivacaine and racemic bupivacaine are actually similar , when used under local intervention of inguinal hernioplasty .


In the field of ambulatorial surgery our working group prefers levobupivacaine for its fewer side effects and for its easy handling .


Spondylodesis in the operative management of lumbar spine diseases has been the subject of numerous studies over several decades .


The posterolateral fusion ( PLF ) with pedicle screw fixation is a commonly used procedure .


To determine whether the addition of bone marrow concentrate ( BMC ) to allograft bone increases fusion rate after instrumented posterior lumbar fusion .


The study was prospective , randomized , controlled , and blinded .


Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF ( @ men , @ women ; body mass index less than @ for a good visualization of the PLF in the X-rays ) .


In @ cases , the PLF was done with spongious allograft chips alone ( Group I , age @ years in average , range @-@ years , level of fusion @-@ ) .


In another @ cases , spongious allograft chips were mixed with BMC ( Group II , age @ years in average , range @-@ , level of fusion @-@ ) , including the mesenchymal stem cells ( MSCs ) .


Patients were scheduled for anteroposterior and lateral radiographs @ and @ months after the surgery and for computed tomography scanning @ months after the surgery .


Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation .


The bony mass was judged as fused if there was uninterrupted bridging of well-mineralized bone between the transverse processes or sacrum , with trabeculation indicating bone maturation on least at one side of the spines .


In Group I at @ months , the bone graft mass was assessed in X-rays as fused in no cases ( @ % ) and at @ months in four cases ( @ % ) .


In Group II , @ cases ( @ % ) achieved fusion at @ months and @ cases ( @ % ) at @ months .


The statistically significant difference between both groups was proven for complete fusion at both @ ( p = @ ) and @ months ( p = @ ) .


Computed tomography scans showed that @ cases ( @ % ) in Group I and @ cases ( @ % ) in Group II had evidence of at least unilateral continuous bridging bone between neighboring vertebrae at @ months ( p < @ ) .


We have confirmed the hypothesis that the autologous BMC together with theallograft is a better alternative for PLF than the allograft alone .


The use of autologous MSCs in form of BMC in combination with allograft is an effective option to enhance the PLF healing .


There is controversy on whether lowering or restricting the level of sympathectomy can reduce compensatory sweating ( CS ) .


This study compared the results from sympathectomies performed to treat severe palmar hyperhidrosis using two distinct levels of T@-@ and T@-@ .


One hundred and sixteen patients with primary palmar hyperhidrosis were randomly allocated to undergo either T@-@ sympathectomy treatment ( T@-@ group ) or T@-@ sympathectomy treatment ( T@-@ group ) .


Follow-up data were collected using a telephone questionnaire to assess efficacy , side effects , overall satisfaction , and factors affecting CS and the degree of satisfaction .


There were no significant differences with respect to either CS or severe CS between the two treatment groups at @ , @ , or @months of follow-up .


The total scores of the quality-of-life questionnaires after surgery were remarkably decreased compared with those before surgery in the two groups .


However , no significant differences in quality-of-life scores were found between the two groups before surgery , or at @ , @ , or @months of follow-up .


Age was predictive of severe CS at @months of follow-up ( P = @ ) .


Severe CS was inversely associated with patient satisfaction at @ , @ , and @months of follow-up .


The issue of whether lowering or restricting the level of sympathectomy reduces CS is controversial and needs more supportive evidence .


Age may be a predictive factor for severe CS at @ and @months of follow-up .


Severe CS is the only known factor that affects patient satisfaction , and family history may also be associated with patient satisfaction .


The aim of this randomized comparative trial ( RCT ) is to compare partial hepatectomy ( PH ) with transcatheter arterial chemoembolization ( TACE ) to treat patients with resectable multiple hepatocellular carcinoma ( RMHCC ) outside of Milan Criteria .


This RCT was conducted on @ patients with RMHCC outside of Milan Criteria ( a solitary tumor up to @ cm or multiple tumors up to @ in number and up to @ cm for each tumor ) who were treated in our centre from November @ to September @ .


The patients were randomly assigned to the PH group or the TACE group .


The primary outcome measure was overall survival ( OS ) from the date of treatment .


A multivariate Cox proportional hazards regression analysis was performed to assess the prognostic risk factors associated with OS .


The @ - , @ - , and @-year OS rates were @ % , @ % , and @ % , respectively , for the PH group compared with @ % , @ % , and @ % , respectively , for the TACE group ( Log-rank test , ( @ ) = @ , p < @ ) .


Multivariate Cox proportional hazards regression analysis revealed the type of treatment ( hazard ratio , @ ; @ % CI , @ to @ , p < @ ) , number of tumor ( hazard ratio , @ ; @ % CI , @ to @ , p = @ ) and gender ( hazard ratio , @ ; @ % CI , @ to @ , p = @ ) were significant independent risk factors associated with OS .


PH provided better OS for patients with RMHCC outside of Milan Criteria than conventional TACE .


The number of tumor and gender were also independent risk factors associated with OS for RMHCC .


The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard @ weeks .


This decision was based in part on data showing increased efficacy for @ weeks of treatment .


Few studies have examined whether the use of nicotine patches beyond @ weeks provides additional therapeutic benefit .


To compare @ ( standard ) , @ ( extended ) , and @ ( maintenance ) weeks of nicotine patch treatment for promoting tobacco abstinence .


We recruited @ treatment-seeking smokers for a randomized clinical trial conducted from June @ , @ , through April @ , @ , through @ universities .


Smokers received @ smoking cessation behavioral counseling sessions and were randomized to @ , @ , or @ weeks of nicotine patch treatment .


The primary outcome was @-day point prevalence abstinence , confirmed with breath levels of carbon monoxide at @ and @ months ( intention to treat ) .


At @ weeks , @ % of participants in the standard treatment arm were abstinent , compared with @ % of participants in the extended and maintenance treatment arms ( ( @ ) ( @ ) = @ ; P = @ ) .


In a multivariate model controlled for covariates , participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at @ weeks compared with participants in the standard treatment arm ( odds ratio -LSB- OR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) , had a longer duration of abstinence until relapse ( = @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) , reported smoking fewer cigarettes per day if not abstinent ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- cigarettes per day ; = @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) , and reported more abstinent days ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- days ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


At @ weeks , participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Similarly , we found no difference in week @ abstinence rates between participants in the extended and standard treatment arms ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Treatment duration was not associated with any adverse effects or adherence to the counseling regimen , but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the standard and extended treatment arms ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- , @ -LSB- @ -RSB- , and @ -LSB- @ -RSB- patches/wk , respectively ; F@ ,@ = @ ; P = @ ) .


The findings support the safety of long-term use of nicotine patch treatment , although they do not support efficacy beyond @ weeks of treatment in a broad group of smokers .


Preexposure prophylaxis ( PrEP ) with emtricitabine plus tenofovir disoproxil fumarate ( FTC/TDF ) or TDF alone reduces the risk of human immunodeficiency virus ( HIV ) acquisition .


Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use .


Within the largest randomized trial of FTC/TDF versus TDF as PrEP , plasma samples were tested for HIV with resistance mutations associated with FTC ( K@R and M@IV ) and TDF ( K@R and K@E ) , using @ sequencing .


Of @ HIV seroconverters , @ received FTC/TDF , @ received TDF , and @ received placebo .


Plasma drug levels in @ individuals indicated PrEP use during or after HIV acquisition , of which @ had virus with resistance mutations associated with their PrEP regimen .


Among those with PrEP drug detected during infection , resistance was more frequent in the FTC/TDF arm ( @ of @ -LSB- @ % -RSB- ) , compared with the TDF arm ( @ of @ -LSB- @ % -RSB- ; P = @ ) , owing to the FTC-associated mutation M@IV .


Of these cases , @ had unrecognized acute infection at PrEP randomization , and @ were HIV negative at enrollment .


These results suggest that resistance selected by PrEP is rare but can occur both with PrEP initiation during acute seronegative HIV infection and in PrEP breakthrough infections and that FTC is associated with a greater frequency of resistance mutations than TDF .


To follow children with juvenile idiopathic arthritis ( JIA ) who had completed at least @ months of the TRial of Early Aggressive Therapy ( TREAT ) clinical study for an additional @ years , describing safety of early aggressive treatment , disease activity , function , and duration of clinical inactive disease ( CID ) during followup .


Children were treated as per provider 's discretion .


Physician , patient/parent , and laboratory measures of disease status as well as safety information were collected at clinic visits every @ months for up to @ years .


Forty-eight children were followed for a mean of @ months ( range @-@ ) beyond the end of the TREAT study .


Half of patients were in CID for > @ % of their followup time .


Overall , @ % of patients achieved CID at > @ study visit and @ % achieved clinical remission while taking medication .


Six patients were in CID for the duration of the study , and , of those , @ achieved a full year of clinical remission while not taking medication .


Active disease was mild : mean physician 's global assessment @ , active joint count @ , parent global evaluation @ , Childhood Health Assessment Questionnaire @ , erythrocyte sedimentation rate @ mm/h , and morning stiffness @ min .


There were no serious adverse events or adverse events reported at grade @ or higher of Common Terminology Criteria for Adverse Events .


Early aggressive therapy in this cohort of patients with polyarticular JIA who had high initial disease activity was associated with prolonged periods of CID in the majority of patients during followup .


Those not in CID had low levels of disease activity .


The aim of the study was to investigate to what extent sweeping of the membranes contributes to cervical shortening and if cervical shortening is related to the time to onset of labor and duration of the active phase of labor


This prospective randomized clinical trial was performed at Baskent University between February and March @ .


Women were randomly assigned to receive membrane sweeping ( Sweeping Group ) ( n = @ ) or no membrane sweeping ( Control Group ) ( n = @ ) .


Cervical length was measured ( cervix@ ) in both groups by examiner @ and the Bishop Score was determined in the control group and sweeping was performed in the sweeping group by examiner @ .


Two days later the patients had another cervical length measurement ( cervix @ ) by examiner @ , blinded to the group and results of the examiner @ .


t test , Mann-Whitney U test and Chi-square test were used for statistical analyses .


Cervix @ was @ + / - @ mm and @ + / - @ mm ( p = @ ) , cervix @ was @ + / - @ mm and @ + / - @ mm ( p = @ ) and cervical shortening was @ + / - @ mm and @ + / -@ mm ( p = @ ) , time to onset of labor was @ + / - @ and @ + / - @ ( p = @ ) and duration of labor was @ + / - @ and @ + / - @ ( p = @ ) for the sweeping and the control groups , respectively


Sweeping of the membranes does not reduce cervical length and does not shorten time to onset of labor and duration of the active phase of labor NCT @ : Sweeping the Membranes , Cervical Length and Duration of Labor


Although dobutamine stress echocardiography ( DSE ) is performed in heart transplant patients , the safety profile of atropine administration in DSE in this setting is unclear .


We identified heart transplant patients who received atropine during DSE from January @ to August @ at our institution and compared them with a propensity-scored matched control group of heart transplant patients who underwent DSE without atropine .


Adverse events were defined as significant arrhythmias ( sinus arrest , Mobitz type II heart block , complete heart block , ventricular tachycardia , or ventricular fibrillation ) , hypotension requiring hospitalization , syncope or presyncope , myocardial infarction , and death .


Forty-five heart transplant patients ( median age @ years , @ % male ) received @-@ mg atropine during DSE .


Of these , @ patient ( @ % ) developed temporary complete heart block .


No adverse events were identified in the control group of @ patients who received dobutamine without atropine .


Our findings suggest that complete heart block can occur infrequently with the administration of atropine in heart transplant patients undergoing DSE .


Therefore , patients should be appropriately monitored for these adverse events during and after DSE .


Efficacy of intravenous ( IV ) volume expansion in preventing contrast-induced acute kidney injury ( CI-AKI ) is well known .


However , the role of oral hydration has not been well established .


The aim of this work was to evaluate the efficacy of oral hydration in preventing CI-AKI .


We prospectively randomized @ patients undergoing coronary angiography and/or percutaneous coronary intervention in either oral hydration or IV hydration groups .


Patients who have at least one of the high-risk factors for developing CI-AKI ( advanced age , type @ diabetes mellitus , anemia , hyperuricemia , a history of cardiac failure or systolic dysfunction ) were included in the study .


All patients had normal renal function or stage @-@ chronic kidney disease .


Patients in the oral hydration group were encouraged to drink unrestricted amounts of fluids freely whereas isotonic saline infusion was performed by the standard protocol in the IV hydration group .


CI-AKI occurred in @/@ patients ( @ % ) in the oral hydration group and @/@ patients ( @ % ) in the IV hydration group ( p = @ ) .


There was also no statistically significant difference between the two groups when different CI-AKI definitions were taken into account .


Oral hydration is as effective as IV hydration in preventing CI-AKI in patients with normal kidney function or stage @-@ chronic kidney disease , and who also have at least one of the other high-risk factors for developing CI-AKI .


Motor imagery ( MI ) is assumed to enhance poststroke motor recovery , yet its benefits are debatable .


Brain-computer interfaces ( BCIs ) can provide instantaneous and quantitative measure of cerebral functions modulated by MI .


The efficacy of BCI-monitored MI practice as add-on intervention to usual rehabilitation care was evaluated in a randomized controlled pilot study in subacute stroke patients .


Twenty-eight hospitalized subacute stroke patients with severe motor deficits were randomized into @ intervention groups : @-month BCI-supported MI training ( BCI group , n = @ ) and @-month MI training without BCI support ( control group ; n = @ ) .


Functional and neurophysiological assessments were performed before and after the interventions , including evaluation of the upper limbs by Fugl-Meyer Assessment ( FMA ; primary outcome measure ) and analysis of oscillatory activity and connectivity at rest , based on high-density electroencephalographic ( EEG ) recordings .


Better functional outcome was observed in the BCI group , including a significantly higher probability of achieving a clinically relevant increase in the FMA score ( p < @ ) .


Post-BCI training changes in EEG sensorimotor power spectra ( ie , stronger desynchronization in the alpha and beta bands ) occurred with greater involvement of the ipsilesional hemisphere in response to MI of the paralyzed trained hand .


Also , FMA improvements ( effectiveness of FMA ) correlated with the changes ( ie , post-training increase ) at rest in ipsilesional intrahemispheric connectivity in the same bands ( p < @ ) .


The introduction of BCI technology in assisting MI practice demonstrates the rehabilitative potential of MI , contributing to significantly better motor functional outcomes in subacute stroke patients with severe motor impairments .


Adequate maternal dietary protein intake is necessary for healthy pregnancy .


However , current protein intake recommendations for healthy pregnant women are based on factorial calculations of nitrogen balance data derived from nonpregnant adults .


Thus , an estimate of protein requirements based on pregnancy-specific data is needed .


The objective of this study was to determine protein requirements of healthy pregnant women at @-@ ( early ) and @-@ ( late ) wk of gestation through use of the indicator amino acid oxidation method .


Twenty-nine healthy women ( @-@ y ) each randomly received a different test protein intake ( range : @-@ @ g kg ( -@ ) d ( -@ ) ) during each study day in early ( n = @ observations in @ women ) and late ( n = @ observations in @ women ) gestation ; @ women participated in both early and late gestation studies .


The diets were isocaloric and provided energy at @ resting energy expenditure .


Protein was given as a crystalline amino acid mixture based on egg protein composition , except phenylalanine and tyrosine , which were maintained constant across intakes .


Protein requirements were determined by measuring the oxidation rate of L - -LSB- @ - ( @ ) C -RSB- phenylalanine to ( @ ) CO@ ( F ( @ ) CO@ ) .


Breath and urine samples were collected at baseline and isotopic steady state .