Each will have an identifiable carer with a minimum of @ hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at @ and @months .


Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars .


Secondary outcome measures will include the risk of falling , quality of life , measures of physical and cognitive function , fear of falling and planned and unplanned use of health services .


Carers will be followed up to determine carer burden , coping strategies and quality of life .


The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program .


The results will have direct implications for the design and implementation of interventions for this high-risk group of older people .


The aim of the article is to determine whether maternal body mass index ( BMI ) influences the beneficial effects of diabetes treatment in women with gestational diabetes mellitus ( GDM ) .


Secondary analysis of a multicenter randomized treatment trial of women with GDM .


Outcomes of interest were elevated umbilical cord c-peptide levels ( > @th percentile @ ng/mL ) , large for gestational age ( LGA ) birth weight ( > @th percentile ) , and neonatal fat mass ( g ) .


Women were grouped into five BMI categories adapted from the World Health Organization International Classification of normal , overweight , and obese adults .


Outcomes were analyzed according to treatment group assignment .


A total of @ women were enrolled ( @ treated and @ controls ) .


Maternal BMI at enrollment was not related to umbilical cord c-peptide levels .


However , treatment of women in the overweight , Class I , and Class II obese categories was associated with a reduction in both LGA birth weight and neonatal fat mass .


Neither measure of excess fetal growth was reduced with treatment in normal weight ( BMI < @ kg/m ( @ ) ) or Class III ( BMI@ kg/m ( @ ) ) obese women .


There was a beneficial effect of treatment on fetal growth in women with mild GDM who were overweight or Class I and Class II obese .


These effects were not apparent for normal weight and very obese women .


Low levels of adiponectin and T in men have been shown to predict development of the metabolic syndrome , but the effects of T on glucose metabolism are incompletely understood and may be influenced either directly or indirectly through changes in body composition or in levels of adiponectin .


The aim of the study was to test whether T exerts its effects on glucose metabolism directly or indirectly .


In a randomized , double-blind , placebo-controlled , crossover study , @ healthy young males were studied on four separate occasions .


They received GnRH agonist treatment @ month before @ of @ trial days to induce castrate levels of T. On trial days , T gel containing either high or low physiological T dose or placebo was applied to the body .


On a fourth trial day , participants constituted their own eugonadal controls .


Each study comprised a @-hour basal period and a @-hour hyperinsulinemic euglycemic clamp .


We measured the effect of acute T on peripheral glucose disposal , total adiponectin and subforms , and other indices of glucose metabolism .


Short-term hypogonadism was associated with increased high molecular weight adiponectin levels ( P < @ ) and increased oxidative glucose disposal ( P = @ ) but not total glucose disposal ( P = @ ) .


Acute T treatment was an independent suppressor of high molecular weight adiponectin levels ( P = @ ) but did not affect total glucose disposal ( P = @ ) .


These data show that T can act through putative fast nongenomic pathways to affect adiponectin levels in humans .


The early hypogonadal state is characterized by a marked shift in fuel oxidation from lipids toward glucose , which may rely partly on buffering capabilities of adiponectin .


The effectiveness of axillary brachial plexus block ( ABPB ) performed using peripheral nerve stimulation ( PNS ) alone was compared with PNS preceded by nerve localization using a pen device , enabling nerve mapping without puncturing the skin .


Patients undergoing unilateral hand or forearm surgery suitable for ABPB were randomly assigned to receive either PNS alone ( pen - group ) or PNS preceded by nerve localization using a pen device ( pen + group ) .


Parameters related to the block procedure and patient comfort were assessed .


Thirty patients were included in each group .


The block performance time was longer in the pen + group than the pen - group despite a reduced number of needle insertions .


The complete block rate was higher and intraoperative analgesic usage lower in the pen + group compared with the pen - group .


Patient satisfaction and complication rates were similar in the two groups .


The pen device seems to be a helpful addition to PNS for ABPB , with improved results in terms of block success and patient comfort , but further studies are needed to confirm these findings .


The purpose of this study was to investigate the effectiveness of a @ percent casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) cream to reduce mutans streptococci ( MS ) colonization and prevent early childhood caries .


The cohort was randomized at mean age of @ days old to receive once-daily CPP-ACP cream ( n = @ ) or no product ( comparison group ; n = @ ) from the time of first tooth eruption .


All mothers were contacted by telephone at six , @ , and @ months and advised to brush their children 's teeth twice daily with low-dose fluoride toothpaste .


At @ months , all children were examined at a community clinic .


At @ months old , one out of @ ( @ percent ) children in the CPP-ACP group had caries vs. four out of @ ( seven percent ) in the comparison group ( difference not statistically significant ) .


There were fewer MS-positive children in the CPP-ACP group ( @ percent ) vs. the comparison group ( @ percent ; P = @ ) .


A dose-response effect of CPP-ACP usage on MS was observed , where MS was present in eight percent of regular CPP-ACP users , @ percent of irregular users , and @ percent of non-users ( P < @ ) .


CPP-ACP reduced the percentages of mutans streptococci-positive @-month-old children , although it did not reduce caries prevalence .


To test the cost-effectiveness of a home-based depression program : Beat the Blues ( BTB ) .


A cost-effectiveness analysis as part of a previously reported randomized controlled trial that compared BTB with a wait-list control group .


Community .


English-speaking , cognitively intact ( Mini-Mental State Examination score @ ) , African Americans aged @ and older with depressive symptoms ( Patient Health Questionnaire score @ ) ( N = @ ) .


Participants randomly assigned to BTB received up to @ home visits over @ months from licensed social workers who provided care management , referral and linkage , stress reduction , depression education , and behavioral activation to help participants achieve self-identified goals .


Incremental cost-effectiveness ratios ( ICERs ) of BTB versus wait-list controls during the @-month study period .


The primary ICER was defined as cost per quality-adjusted life year ( QALY ) using the Euro Quality of Life @D ( EQ-@D ) and secondarily using the Health Utilities Index-@ ( HUI-@ ) .


Additional ICERs were calculated using clinical measures ( cost per depression improvement , cost per depression remission ) .


Costs included BTB intervention , depression-related healthcare visits and medications , caregiver time , and social services .


BTB cost per participant per month was $ @ .


Base case ICERs were $ @,@ per QALY ( EQ-@D ) and $ @,@ per QALY ( HUI-@ ) .


Incremental cost was $ @,@ per depression improvement and $ @,@ per remission .


Univariate and probabilistic sensitivity analyses yielded a cost/QALY range of $ @,@ to $ @,@ .


Based on the range of cost-effectiveness values resulting from this study , BTB is a cost-effective treatment for managing depressive symptoms in older African Americans that compares favorably with the cost-effectiveness of previously tested approaches .


Most patients relapse to opioids within one month of opioid agonist detoxification , making the antecedents and parallel processes of first use critical for investigation .


Craving and withdrawal are often studied in relationship to opioid outcomes , and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies .


Specifically , this secondary data analysis of the Prescription Opioid Addiction Treatment Study used a discrete-time mixture analysis with time-to-first opioid use ( survival ) simultaneously predicted by craving and withdrawal growth trajectories .


This analysis characterized heterogeneity among prescription opioid-dependent individuals ( N = @ ) into latent classes ( i.e. , latent class analysis -LSB- LCA -RSB- ) during and after buprenorphine/naloxone stabilization and taper .


A @-latent class solution was selected for overall model fit and clinical parsimony .


In order of shortest to longest time-to-first use , the @ classes were characterized as @ ) high craving and withdrawal , @ ) intermediate craving and withdrawal , @ ) high initial craving with low craving and withdrawal trajectories and @ ) a low initial craving with low craving and withdrawal trajectories .


Odds ratio calculations showed statistically significant differences in time-to-first use across classes .


Generally , participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer .


This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction , stabilization , and taper .


Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use .


Acne keloidalis nuchae ( AKN ) is a chronic scarring folliculitis with fibrotic papules on the occipital scalp .


Its treatment is limited and unsatisfactory .


To determine whether targeted ultraviolet B ( tUVB ) phototherapy will ( i ) improve the clinical appearance of AKN and ( ii ) induce extracellular matrix remodelling in affected lesions .


Eleven patients with AKN were enrolled in a prospective , randomized , split-scalp comparison study .


One randomly selected side of the scalp was treated with tUVB up to three times weekly for @weeks .


After week @ , both sides were treated for eight additional weeks .


Assessment included lesion counts in two @-cm regions of interest ( ROIs ) , one on each side of the scalp ( ROI-@ : tUVB weeks @-@ , ROI-@ : tUVB weeks @-@ ) , patient self-assessment and analysis of MMP@ , MMP@ , TGFB@ and COL@A@ mRNA expression by quantitative reverse-transcription polymerase chain reaction .


Before treatment , the mean lesion count was similar between tUVB-treated and untreated sides ( @ vs. @ ) .


After @weeks of tUVB , the mean lesion count decreased significantly to @ ( P = @ ) , with no change on the untreated side .


With continued treatment , the mean lesion count in ROI-@ decreased further to @ ( P = @ ) after @weeks of tUVB .


tUVB significantly improved the clinical appearance of AKN , led to patient satisfaction and was well tolerated .


Carpal tunnel syndrome ( CTS ) is a common condition ( prevalence of @ % ) where the median nerve is compressed within the carpal tunnel resulting in numbness , tingling , and pain in the hand .


Current non-surgical treatment options ( oral medication , corticosteroid injections , splinting , exercise , and mobilization ) show limited effects , especially in the long-term .


Carpal tunnel release ( CTR ) surgery is effective in @ to @ % of patients , but is relatively invasive and can be accompanied by complications .


In an observational study , mechanical traction proved to be effective in up to @ % of patients directly after treatment and in @ % after two years follow-up .


This randomized controlled trial ( RCT ) will examine the effectiveness of mechanical traction compared to care as usual in CTS .


Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group ( mechanical traction ) or the control group ( care as usual ) .


Participants in the intervention group will receive @ treatments with mechanical traction during six consecutive weeks .


Primary outcome is symptom severity and functional status , which are measured with the Boston Carpel Tunnel Questionnaire ( BCTQ ) .


Secondary outcomes are quality of life ( WHOQOL-BREF ) , health related resource utilization , and absenteeism from work .


Outcomes will be assessed at baseline , and at @ , @ , and @months after inclusion .


Linear mixed effect models will be used to determine the change from baseline at @months on the BCTQ , WHOQOL-BREF , absenteeism from work and health related resource utilization .


The baseline measurement , change from baseline at three and six months , as well as duration of symptoms until inclusion , age , gender , and co-morbidity will be included as covariates The Pearson 's correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome .


Since current non-surgical treatment options are not effective long-term and CTR is relatively invasive , there is a need for an effective and non-invasive treatment option .


Mechanical traction is a safe treatment option that may provide a good alternative for the usual care .


Considering the prevalence of CTS , the study is of great clinical value to a large patient population .


Effective prophylactic therapies have not been established for hepatocellular carcinoma recurrence .


Peretinoin represents one novel option for patients with hepatitis C virus-related hepatocellular carcinoma ( HCV-HCC ) , and it was tested in a multicenter , randomized , double-blind , placebo-controlled study .


Patients with curative therapy were assigned to one of the following regimens : peretinoin @ , @ mg/day , or placebo for up to @ weeks .


The primary outcome was recurrence-free survival ( RFS ) .


Of the @ patients initially enrolled , @ patients were analyzed for efficacy .


The RFS rates in the @-mg group , the @-mg group , and the placebo group were @ , @ , and @ % at @ year , and @ , @ , and @ % at @ years , respectively .


The primary comparison of peretinoin ( @ and @-mg ) with placebo was not significant ( P = @ ) .


The dose-response relationship based on the hypothesis that `` efficacy begins to increase at @ mg/day '' was significant ( P = @ , multiplicity-adjusted P = @ ) .


The hazard ratios for RFS in the @-mg group vs. the placebo group were @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- for the entire study period and @ ( @ % CI @-@ @ ) after @ years of the randomization .


Common adverse events included ascites , increased blood pressure , headache , presence of urine albumin , and increased transaminases .


Although the superiority of peretinoin to placebo could not be validated , @ mg/day was shown to be the optimal dose , and treatment may possibly reduce the recurrence of HCV-HCC , particularly after @ years .


The efficacy and safety of peretinoin @ mg/day should continue to be evaluated in further studies .


Postoperative delirium is one of the most common complications of major surgery , affecting @-@ % of surgical patients @ years and older .


Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit ( ICU ) and hospital stay , long-lasting cognitive deterioration and increased mortality .


Ketamine has been used as an anaesthetic drug for over @ years and has an established safety record .


Recent research suggests that , in addition to preventing acute postoperative pain , a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes .


However , these proposed benefits of ketamine have not been tested in a large clinical trial .


The Prevention of Delirium and Complications Associated with Surgical Treatments ( PODCAST ) study is an international , multicentre , randomised controlled trial .


@ cardiac and major non-cardiac surgery patients will be randomised to receive ketamine ( @ or @ mg/kg ) or placebo following anaesthetic induction and prior to surgical incision .


For the primary outcome , blinded observers will assess delirium on the day of surgery ( postoperative day @ ) and twice daily from postoperative days @-@ using the Confusion Assessment Method or the Confusion Assessment Method for the ICU .


For the secondary outcomes , blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report .


Malnutrition is common in patients with advanced epithelial ovarian cancer ( EOC ) , and is associated with impaired quality of life ( QoL ) , longer hospital stay and higher risk of treatment-related adverse events .


This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL .


From @ to @ , @ patients requiring surgery for suspected advanced EOC , moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention ( n = @ ) or control ( n = @ ) groups .


Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained .


Despite being randomised to intervention , @ patients did not receive feeds ( @ did not receive the feeding tube ; @ had it removed early ) .


Control involved postoperative diet as tolerated .


QoL was measured at baseline , @weeks postoperatively and @days after the third cycle of chemotherapy .


The primary outcome measure was the difference in QoL between the intervention and the control group .


Secondary endpoints included treatment-related adverse event occurrence , length of stay , postoperative services use , and nutritional status .


Baseline characteristics were comparable between treatment groups .


No significant difference in QoL was found between the groups at any time point .


There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at @days postoperatively ( @ intervention vs. @ control , p @ ) .


Early enteral feeding did not significantly improve patients ' QoL compared to standard of care but may improve nutritional status .


As healthcare services become progressively more stretched , there is increasing discussion of ways in which technological adjuncts may be used to deliver more cost-efficient services .


Before widespread implementation , however , the use of these adjuncts requires proper scrutiny of their effects on psychological practice .


This research examined the effectiveness of SMS reminders on client appointment attendance and dropout in a psychological treatment setting .


It was predicted that the reminders would result in increased initial appointment attendance , increased total appointment attendance , and decreased client dropout .


A randomized controlled trial investigated the impact of SMS appointment reminders ( two levels : present or absent ) on client attendance ( three levels : attended , rescheduled , or did not attend ) and dropout ( two levels : completed treatment or terminate early ) .


Participants ( N = @ ) at an outpatient psychology clinic were randomly allocated to either receive an SMS appointment reminder one day before their scheduled appointment , or to receive no reminder .


No significant differences were found between the SMS and no SMS conditions in relation to appointment attendance .


There were more client dropouts in the SMS compared to the no SMS condition .


The SMS appointment reminders were not effective at increasing appointment attendance .


The current research suggests that there is more to client non-attendance in psychological settings than the simple forgetting of appointments .


Technological adjuncts may be useful in increasing the cost-efficiency of current services ; however , this research highlights the importance of understanding the effects of technology before widespread implementation .


In this study , our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission .


Secondary objectives were the time to peristalsis recovery and the incidence of wound infection , anastomotic leaks , and mortality .


A randomized clinical trial was conducted in @ tertiary hospitals .


One hundred forty-two adult patients scheduled for open colorectal surgery , gastrectomy , or small bowel resection were enrolled .


A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure , cardiac index , and stroke volume response was compared with standard practice .


Patients were followed until hospital discharge ( determined by a surgeon blinded to the study ) or death .


In contrast to previous studies , we designed a pragmatic trial ( as opposed to explanatory trials ) to mimic real practice and obtain maximal external validity for the study .


Fluid administration was similar except for the number of colloid boluses ( @ @ -LSB- treated -RSB- vs @ @ -LSB- control -RSB- ; P < @ ) and packed red blood cell units ( @ @ -LSB- treated -RSB- vs @ @ -LSB- control -RSB- ; P = @ ) .


Dobutamine was used in @ % ( intraoperatively ) and @ % ( postoperatively ) of the treated patients versus @ % and @ % in the control group ( P < @ ) .


We have observed a reduction in reoperations in the treated group ( @ % vs @ % ; P = @ ) .


However , no significant differences were observed in overall complications ( @ % vs @ % ; relative risk @ -LSB- @-@ @ -RSB- ; P = @ ) , length of stay ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- ; P = @ ) , time to first flatus ( @ hours -LSB- @-@ -RSB- vs @ hours -LSB- @-@ -RSB- ; P = @ ) , wound infection ( @ vs @ ; P = @ ) , anastomotic leaks ( @ vs @ ; P = @ ) , or mortality ( @ % vs @ % ; P = @ ) .


The results of our pragmatic study indicate that a perioperative hemodynamic protocol guided by a noninvasive cardiac output monitor was not associated with a decrease in the incidence of overall complications or length of stay in major abdominal surgery .


The quality of cardiopulmonary resuscitation ( CPR ) affects hemodynamics , survival , and neurological outcomes following pediatric cardiopulmonary arrest ( CPA ) .


Most health care professionals fail to perform CPR within established American Heart Association guidelines .


To determine whether `` just-in-time '' ( JIT ) CPR training with visual feedback ( VisF ) before CPA or real-time VisF during CPA improves the quality of chest compressions ( CCs ) during simulated CPA .


Prospective , randomized , @ factorial-design trial with explicit methods ( July @ , @ , to April @ , @ ) at @ International Network for Simulation-Based Pediatric Innovation , Research , & Education ( INSPIRE ) institutions running a standardized simulated CPA scenario , including @ CPR-certified health care professionals assigned to @-person resuscitation teams ( @ teams ) .


Each team was randomized to @ of @ permutations , including JIT training vs no JIT training before CPA and real-time VisF vs no real-time VisF during simulated CPA .


The proportion of CCs with depth exceeding @ mm , the proportion of CPR time with a CC rate of @ to @ per minute , and CC fraction ( percentage CPR time ) during simulated CPA .


The quality of CPR was poor in the control group , with @ % ( @ % CI , @ % -@ % ) mean depth compliance and @ % ( @ % CI , @ % -@ % ) mean rate compliance .


JIT training compared with no JIT training improved depth compliance by @ % ( @ % CI , @ % -@ % ; P < @ ) and rate compliance by @ % ( @ % CI , @ % -@ % ; P = @ ) .


Visual feedback compared with no VisF improved depth compliance by @ % ( @ % CI , @ % -@ % ; P = @ ) and rate compliance by @ % ( @ % CI , @ % -@ % ; P < @ ) .


Neither intervention had a statistically significant effect on CC fraction , which was excellent ( > @ % ) in all groups .


Combining both interventions showed the highest compliance with American Heart Association guidelines but was not significantly better than either intervention in isolation .


The quality of CPR provided by health care professionals is poor .


Using novel and practical technology , JIT training before CPA or real-time VisF during CPA , alone or in combination , improves compliance with American Heart Association guidelines for CPR that are associated with better outcomes .


Multiple sclerosis ( MS ) is an immune-mediated neurodegenerative disease of central nervous system and recent studies show that inflammatory processes are highly associated with neurodegeneration in the brain .


The purpose of this study was to investigate the effect of coenzyme Q@ supplementation on inflammatory and anti-inflammatory markers in patients with MS.


This randomized , double-blind , placebo-controlled clinical study was performed among @ patients with relapsing-remitting MS. Subjects were randomly assigned to a placebo group ( n = @ ) or coenzyme Q@ ( CoQ@ ) - supplemented group ( @ mg/day , n = @ ) .


The intervention was administered for @ weeks .


Peripheral blood samples were collected at baseline and after @-week intervention , to measure inflammatory ( tumor necrosis factor - ( TNF - ) , interleukin ( IL ) -@ , and matrix metalloproteinase ( MMP ) -@ ) and anti-inflammatory ( IL-@ and TGF - ) markers .


Forty-five patients completed the study .


After @ weeks of intervention , the TNF - levels ( P = @ ) decreased significantly in the CoQ@ group .


Subjects in the CoQ@ group had significantly lower IL-@ levels ( P = @ ) , compared to the placebo group .


CoQ@ supplementation also resulted in decreased serum levels of MMP-@ as compared to the placebo group ( P = @ ) .


However , CoQ@ supplementation did not alter the IL-@ and TGF - levels ( P = @ and P = @ , respectively ) .


CoQ@ supplementation at a dosage of @ mg appears to decrease the inflammatory markers ( TNF - , IL-@ , and MMP-@ ) in patients with MS.


The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type @ diabetes ( T@D ) .


This was a randomized double-blind , parallel , placebo-controlled trial .


The study was conducted at a tertiary referral center .


Men aged @-@ years with T@D , a hemoglobin A@c less than @ % , and a total T level less than @ nmol/L ( @ ng/dL ) with mild to moderate aging male symptoms and erectile dysfunction .


Eighty-eight participants were randomly assigned to @ weeks of im T undecanoate ( n = @ ) or matching placebo ( n = @ ) .


Constitutional symptoms using the aging male symptoms ( AMS ) score , sexual desire ( question @ AMS score ) , and erectile function ( International Index of Erectile Function-@ ) .


T treatment did not substantially improve aging male symptoms -LSB- mean adjusted difference ( MAD ) in change over @ weeks across the T and placebo groups in AMS total score , -@ ( @ % confidence interval -LSB- CI -RSB- -@ , @ ) , P = @ -RSB- or sexual desire -LSB- MAD in question @ AMS , -@ ( @ % CI -@ , @ ) , P = @ -RSB- .


Although compared with placebo , erectile function in men assigned to T was reduced -LSB- MAD in International Index of Erectile Function abridged version @ , -@ ( @ % CI -@ , -@ ) , P < @ -RSB- , there was no significant difference between baseline and @-week International Index of Erectile Function abridged version @ scores if both groups were analyzed separately .


At baseline , symptoms were worse in men with depression and microvascular complications but did not correlate with T levels .


In this trial , T treatment did not substantially improve constitutional or sexual symptoms in obese , aging men with T@D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men .


According to the findings of some studies , instability due to inertia during changes in speed may negatively impact the quality of chest compressions performed during cardiopulmonary resuscitation ( CPR ) in a moving environment .


This study thus aimed to introduce a simple device that maintains the balance of a person performing CPR in a moving environment , such as an ambulance .


We also sought to evaluate the effectiveness of this device in the improvement of the quality of chest compressions .


The experiment comprised a total of @ simulated cardiopulmonary arrest scenes ( @ in the experimental group and @ in the control ) , in which CPR was conducted by eight paramedics .


Each simulation involved two paramedics randomly selected from the eight .


The ambulance took the same route from the simulated site to the hospital , and continuous CPR was performed on a manikin in the ambulance with or without the aid of our proposed novel device .


The average number of chest compressions per simulation in the experimental and control groups was @ and @ , respectively ( p = @ ) .


The percentage of chest compressions with adequate depth achieved in the experimental and control groups was @ % @ % and @ % @ % , respectively ( p < @ ) .


By maintaining the balance of the CPR performer , our proposed novel device can offset the negative impact that instability ( due to a moving environment ) has on chest compressions .


The device may also lead to an increase in the percentage of chest compressions that achieve adequate depth .


This pilot study examined , whether long-term exposure of psychiatric patients to music that was individually adapted to brain rhythm disorders associated with psychoticism could act to ameliorate psychiatric symptoms .


A total of @ patients with various psychiatric diagnoses were randomised in a @:@ ratio to listen to CDs containing either music adapted to brain rhythm anomalies associated with psychoticism - measured via a specific spectral analysis - or standard classical music .


Participants were instructed to listen to the CDs over the next @ months .


Psychiatric symptoms in both groups were assessed at baseline and at @ , @ and @ months , using the Brief Symptom Inventory ( BSI ) .


At @ months , patients in the experimental group showed significantly decreased BSI scores compared to control patients .


Intriguingly , this effect was not only seen for symptoms of psychoticism and paranoia but also for anxiety , phobic anxiety and somatisation .


Exposure to the adapted music was effective in ameliorating psychotic , anxiety and phobic anxiety symptoms .


Based on the theories of neuroplasticity and brain rhythms , it can be hypothesised that this intervention may be enhancing brain-rhythm synchronisation and plasticity in prefrontal-hippocampal circuits that are implicated in both psychosis/paranoia and anxiety/phobic anxiety .


High US sodium intake and national reduction efforts necessitate developing a feasible and valid monitoring method across the distribution of low-to-high sodium intake .


We examined a statistical approach using timed urine voids to estimate the population distribution of usual @-h sodium excretion .


A sample of @ adults , aged @-@ y ( @ % female , @ % black ) , collected each void in a separate container for @ h ; @ repeated the procedure @-@ d later .


Four timed voids ( morning , afternoon , evening , overnight ) were selected from each @-h collection .


We developed gender-specific equations to calibrate total sodium excreted in each of the one-void ( e.g. , morning ) and combined two-void ( e.g. , morning + afternoon ) urines to @-h sodium excretion .


The calibrated sodium excretions were used to estimate the population distribution of usual @-h sodium excretion .


Participants were then randomly assigned to modeling ( n = @ ) or validation ( n = @ ) groups to examine the bias in estimated population percentiles .


Median bias in predicting selected percentiles ( @th , @th , @th , @th , @th ) of usual @-h sodium excretion with one-void urines ranged from -@ to @ mg ( -@ to @ % of the observed usual excretions ) for men and -@ to @ mg ( -@ to @ % ) for women , and with two-void urines from -@ to @ mg ( -@ to @ % ) and -@ to @ mg ( -@ to @ % ) , respectively .


Four of the @ two-void urine combinations produced no significant bias in predicting selected percentiles .


Our approach to estimate the population usual @-h sodium excretion , which uses calibrated timed-void sodium to account for day-to-day variation and covariance between measurement errors , produced percentile estimates with relatively low biases across low-to-high sodium excretions .


This may provide a low-burden , low-cost alternative to @-h collections in monitoring population sodium intake among healthy young adults and merits further investigation in other population subgroups .


To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule ( , BHG ) on Parkinson 's disease ( PD ) patients with depressive state .


Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table , @ in each group .


Madopar was given to all as the conventional treatment .


The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group .


The therapeutic course for all was @ weeks .


Before and after treatment , Hamilton depression rating scale ( HAMD ) was applied to judge the curative effect , and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique .


The scores of HAMD in the two groups were decreased markedly after @-week treatment .


It was lower in the treatment group than that in the control group with significant difference ( P < @ ) .


The contents of norepinephrine ( NE ) and @-serotonin ( @-HT ) in the PD patients were obviously lower than normal value .


There was no significant difference between the two groups before treatment ( P > @ ) .


The contents of NE and @-HT were all increased in the two groups after treatment ( P < @ ) , with significant differences between the two groups ( P < @ ) .


BHG could increase the contents of NE and @-HT in PD patients ' brain to improve the depressive state of PD patients .


The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown .


The purpose of the study was to examine the relative effectiveness of @ alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity .


Substudy within a large @-armed randomized controlled trial , which compared @ different models of physiotherapy service delivery , was provided for @ weeks during subacute , inpatient rehabilitation ( n = @ ) .


The duration of all physiotherapy sessions was recorded .


In addition , @ participants were observed at @-minute intervals for @ weekday and @ weekend day between @:@ am and @:@ pm .


At each observation , we recorded physical activity , location , and people present .


Participants receiving @-day-week and circuit class therapy received an additional @ hours and @ hours of physiotherapy time , respectively , when compared with usual care .


Participants were standing or walking for a median of @ % of observations .


On weekdays , circuit class therapy participants spent more time in therapy-related activity ( @ % of observations ) when compared with usual care participants ( @ % of observations ) .


On weekends , @-day therapy participants spent more time in therapy-related activity ( @ % of observations ) when compared with both usual care and circuit class therapy participants ( @ % of observations for both groups ) .


Activity levels outside of therapy sessions did not differ between groups .


A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day .


Repetitive transcranial magnetic stimulation ( rTMS ) of the left dorsolateral-prefrontal cortex ( DLPFC ) exerts antidepressant effects .


In this randomised controlled clinical trial we aimed to test the safety and therapeutic efficacy of bilateral theta-burst stimulation ( TBS ) as an add-on therapy to standard treatment of major depression .


Fifty-six patients diagnosed with a moderate to severe depressive episode received @ daily treatments of either rTMS ( @ % motor-threshold ; rightDLPFC , @ stimuli at @ Hz + leftDLPFC , @ stimuli at @ Hz ) , theta-burst stimulation ( @ % motor-threshold ; rightDLPFC , continuous TBS , @ stimuli + leftDLPFC , intermittent TBS , @ stimuli ) , or sham TMS ( N = @ , sham coil with the TBS protocol ) .


There was no significant effect in the primary outcome measures ( change of the @-item Hamilton Rating Scale for Depression ) .


However , there was a tendency towards an increased responder rate at the end of the follow-up period for both active treatments as compared to sham , and this tendency was most pronounced for the TBS group .


This pilot study did not reveal significant advantages of bilateral TBS or rTMS over sham treatment as an add-on treatment for major depression .


A tendency towards a superior effect of bilateral TBS at the end of the follow-up period may warrant further studies .


This study aimed to assess the dose and volume effects of suppository preparations and safety of NRL@ ( one of four possible stereoisomers of methoxamine hydrochloride ) on anal sphincter tone using rectal suppositories in healthy adult volunteers .


This was a Phase I , single-centre , randomised , double-blind , three-way crossover study during which subjects received three single doses of @ g rectal suppositories ( containing @ or @ mg NRL@ or matching placebo ) or @ g rectal suppositories ( containing @ or @ mg NRL@ or matching placebo ) on three separate dosing days .


The outcome measures were mean anal resting pressure ( MARP ) variables ( monitored continuously for @-@ min before and up to @ h after dosing ) , pharmacokinetics ( PK ) and safety assessments .


Twenty-six subjects were dosed with study medication .


Two subjects were withdrawn prematurely and were not included in the main analysis .


There was a dose-dependent increase in anal sphincter tone ( MARP ) when comparing the @ and @ mg doses of NRL@ ; however , the @ mg dose did not have a significantly greater effect than the @ mg dose .


Suppository size ( @ or @ g ) did not appear to have an effect on sphincter tone .


There was no evidence against dose proportionality for the PK variables , but the mean maximum plasma concentration ( Cmax ) for the @ g suppository group was higher than for the @ g group .


Twenty-one adverse events were reported in @ ( @ % ) subjects .


A dose dependent decrease in heart rate was noted ; however , there were no adverse events reported that were related to this reduction in heart rate .


The increase in anal sphincter tone supports the potential therapeutic use of NRL@ in treating faecal incontinence , with further studies in patients required .


NRL@ was well tolerated in single doses of up to @ mg .


Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events .


There has been minimal study of collaborative care ( CC ) management models for mental health disorders in high-risk cardiac inpatients , and no prior CC intervention has simultaneously managed depression and anxiety disorders .


To determine the impact of a low-intensity CC intervention for depression , generalized anxiety disorder , and panic disorder among patients hospitalized for an acute cardiac illness .


Single-blind randomized clinical trial , with study assessors blind to group assignment , from September @ through July @ of @ patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome , arrhythmia , or heart failure and found to have clinical depression , generalized anxiety disorder , or panic disorder on structured assessment .


Participants were randomized to @ weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders ( n = @ ) or to enhanced usual care ( serial notification of primary medical providers ; n = @ ) .


The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate .


Improvement in mental health-related quality of life ( Short Form-@ Mental Component Score -LSB- SF-@ MCS -RSB- ) at @ weeks , compared between groups using a random-effects model in an intent-to-treat analysis .


Patients randomized to CC had significantly greater estimated mean improvements in SF-@ MCS at @ weeks ( @ points -LSB- from @ to @ -RSB- in the CC group vs @ points -LSB- from @ to @ -RSB- in the control group ; estimated mean difference , @ points -LSB- @ % CI , @-@ @ -RSB- ; P = @ ; effect size , @ ) .


Patients receiving CC also had significant improvements in depressive symptoms and general functioning , and higher rates of treatment of a mental health disorder ; anxiety scores , rates of disorder response , and adherence did not differ between groups .


A novel telephone-based , low-intensity model to concurrently manage cardiac patients with depression and/or anxiety disorders was effective for improving mental health-related quality of life in a @-week trial .


There are conflicting results on the impact of anxiety on depression outcomes .


The impact of anxiety has not been studied in major depression with psychotic features ( `` psychotic depression '' ) .


We assessed the impact of specific anxiety symptoms and disorders on the outcomes of psychotic depression .


We analyzed data from the Study of Pharmacotherapy for Psychotic Depression that randomized @ younger and older participants to either olanzapine plus placebo or olanzapine plus sertraline .


We assessed the impact of specific anxiety symptoms from the Brief Psychiatric Rating Scale ( `` tension '' , `` anxiety '' and `` somatic concerns '' and a composite anxiety score ) and diagnoses ( panic disorder and GAD ) on psychotic depression outcomes using linear or logistic regression .


Age , gender , education and benzodiazepine use ( at baseline and end ) were included as covariates .


Anxiety symptoms at baseline and anxiety disorder diagnoses differentially impacted outcomes .


On adjusted linear regression there was an association between improvement in depressive symptoms and both baseline `` tension '' ( coefficient = @ ; @ % CI : @-@ @ ; p = @ ) and the composite anxiety score ( regression coefficient = @ ; @ % CI : @-@ @ ; p = @ ) .


There was an interaction between `` tension '' and treatment group , with better responses in those randomized to combination treatment if they had high baseline anxiety scores ( coefficient = @ ; @ % CI : @-@ @ ; p = @ ) .


In contrast , panic disorder was associated with worse clinical outcomes ( coefficient = -@ ; @ % CI : -@ to -@ ; p = @ ) regardless of treatment .


Our results suggest that analysis of the impact of anxiety on depression outcome needs to differentiate psychic and somatic symptoms .


To evaluate the feasibility and appropriateness of a prehospital system allowing ambulance nurses to transport older adults directly to geriatric care at a community-based hospital ( CH ) or to an emergency department ( ED ) .


Randomized controlled trial .


Emergency medical services in Stockholm , Sweden .


Older adults who called the emergency number were randomized to an intervention group ( n = @ ) or a control group ( n = @ ) .


The dispatcher randomized the individuals .


Those randomized to the intervention group were transported to several alternative destinations decided by a trained nurse performing a comprehensive assessment , using the new prehospital system .


Those randomized to the control group were transported to the ED .


Primary endpoint : number of individuals triaged directly to a CH ( feasibility ) .


Secondary endpoint : number of subsequent transfers ( appropriateness ) from CH to ED within @ hours after initial admission .


After exclusion and crossover , the control group consisted of @ and the intervention group of @ older adults .


The nurse sent @ % of the intervention group ( @/@ ) ( @ % confidence interval ( CI ) = @-@ @ ) directly to the CH when using the prehospital system .


Six of those individuals ( @ % ) ( @ % CI = @-@ @ ) were subsequently transferred from the CH to the ED .


Overall , the nurse appropriately triaged @ % of the participants ( @/@ ) and transferred them to the CH , avoiding an ED visit .


Ambulance nurses are able to send older adults to an alternative healthcare facility with the help of a prehospital decision support system .


In this geographical setting , this appears to be a promising method to optimize resources and improve emergency care of elderly adults .


The culture in many team sports involves consumption of large amounts of alcohol after training/competition .


The effect of such a practice on recovery processes underlying protein turnover in human skeletal muscle are unknown .


We determined the effect of alcohol intake on rates of myofibrillar protein synthesis ( MPS ) following strenuous exercise with carbohydrate ( CHO ) or protein ingestion .


In a randomized cross-over design , @ physically active males completed three experimental trials comprising resistance exercise ( @ reps leg extension , @ % @ repetition maximum ) followed by continuous ( @ min , @ % peak power output ( PPO ) ) and high intensity interval ( @ s , @ % PPO ) cycling .


Immediately , and @ h post-exercise , subjects consumed either @ mL of whey protein ( @ g ; PRO ) , alcohol ( @ gkg body mass ) , @ standard drinks ) co-ingested with protein ( ALC-PRO ) , or an energy-matched quantity of carbohydrate also with alcohol ( @ g maltodextrin ; ALC-CHO ) .


Subjects also consumed a CHO meal ( @ g CHOkg body mass ) @ h post-exercise .


Muscle biopsies were taken at rest , @ and @ h post-exercise .


Blood alcohol concentration was elevated above baseline with ALC-CHO and ALC-PRO throughout recovery ( P < @ ) .


Phosphorylation of mTOR ( Ser@ ) @ h after exercise was higher with PRO compared to ALC-PRO and ALC-CHO ( P < @ ) , while p@S@K phosphorylation was higher @ h post-exercise with ALC-PRO and PRO compared to ALC-CHO ( P < @ ) .


Rates of MPS increased above rest for all conditions ( @-@ % , P < @ ) .


However , compared to PRO , there was a hierarchical reduction in MPS with ALC-PRO ( @ % , P < @ ) and with ALC-CHO ( @ % , P < @ ) .


We provide novel data demonstrating that alcohol consumption reduces rates of MPS following a bout of concurrent exercise , even when co-ingested with protein .


We conclude that alcohol ingestion suppresses the anabolic response in skeletal muscle and may therefore impair recovery and adaptation to training and/or subsequent performance .


Postprandial hyperglycemia and blood glucose fluctuations increase the risk of macroangiopathy in patients with type @ diabetes mellitus ( T@DM ) .


However , few studies have examined the effects of oral hypoglycemic drugs on blood glucose fluctuations in daily life .


Twenty-nine T@DM patients treated with acarbose were randomized to receive either sitagliptin ( @ patients ) or mitiglinide ( @ patients ) together with acarbose for @ weeks .


Patients were then switched to a combination of @ mg mitiglinide and @ mg voglibose for @ weeks .


All patients wore a continuous glucose monitoring ( CGM ) device for @ - @ days in week @ of each treatment period .


The percentage of blood glucose levels in the hyperglycemic range , blood glucose indices derived from @-h CGM profiles and the glycemic parameters ( HbA@c , glycated albumin and fasting plasma glucose ) were significantly improved by adding sitagliptin or mitiglinide to ongoing acarbose therapy .


These parameters also tended to improve in the mitiglinide/voglibose combination period .


Daily blood glucose fluctuations were significantly improved by adding sitagliptin or mitiglinide to acarbose , and improved after switching to the mitiglinide/voglibose combination .


Larger controlled studies are needed to verify the effects of adding sitagliptin or mitiglinide to acarbose on glucose fluctuations .


Premenstrual syndrome ( PMS ) may have negative effects on women 's health and sometimes need therapeutic non-pharmacological management .


To determine the effect of oral consumption of @ mg Royal Jelly capsule on premenstrual syndrome .


This is a randomized , triple-blind , placebo-controlled clinical trial , which was conducted in Tehran University of Medical Sciences female dormitories between December @ and October @ .


The study population comprised @ medical sciences student with PMS , whom were randomly assigned to an intervention or a control group .


Each participant in the intervention group took one Royal jelly capsule orally per day , starting on the first day of menstruation and continued the same treatment daily throughout two consecutive menstrual cycles , while participants in the intervention group took placebo capsules as same method .


The outcome measure in this study was PMS score as obtained through the Premenstrual Profile @ .


The mean of personal characteristics and baseline level of the premenstrual score before intervention did not differ between groups .


After two consecutive months consumption of Royal Jelly , PMS score had decreased from @ @ to @ @ ( mean change : @ ; @ % confidence interval -LSB- CI -RSB- : @-@ @ ) and in Placebo , PMS score changed from @ @ to @ @ ( mean change : @ ; @ % CI : -@ to @ ) .


Also difference between mean changes was significant ( mean difference : @ ; @ % CI : @-@ @ ) .


The results of the study have demonstrated that @ months consumption of Royal Jelly was effective in reducing PMS .


An earlier randomized controlled trial found that two middle school sexual education programs-a risk avoidance ( RA ) program and a risk reduction ( RR ) program-delayed initiation of sexual intercourse ( oral , vaginal , or anal sex ) and reduced other sexual risk behaviors in ninth grade .


We examined whether these effects extended into @th grade .


Fifteen middle schools were randomly assigned to RA , RR , or control conditions .


Follow-up surveys were conducted with participating students in @th grade ( n = @,@ ; @ % attrition ) .


Participants were @ % female , @ % Hispanic , and @ % black ; seventh grade mean age was @ years .


In @th grade , compared with the control condition , both programs significantly delayed anal sex initiation in the total sample ( RA : adjusted odds ratio -LSB- AOR -RSB- , @ , @ % confidence interval -LSB- CI -RSB- , @ -@ ; RR : AOR , @ , @ % CI , @ -@ ) and among Hispanics ( RA : AOR , @ , @ % CI , @ -@ ; RR : AOR , @ , @ % CI , @ -@ ) .


Risk avoidance students were less likely to report unprotected vaginal sex , either by using a condom or by abstaining from sex ( AOR : @ , @ % CI , @ -@ ) ; RR students were less likely to report recent unprotected anal sex ( AOR : @ , @ % CI , @ -@ ) .


Both programs sustained positive impact on some psychosocial outcomes .


Although both programs delayed anal sex initiation into @th grade , effects on the delayed initiation of oral and vaginal sex were not sustained .


Additional high school sexual education may help to further delay sexual initiation and reduce other sexual risk behaviors in later high school years .


Lutein accumulates in the macula and brain , where it is assumed to play physiologic roles .


The bioavailability of lutein is assumed to display a high interindividual variability that has been hypothesized to be attributable , at least partly , to genetic polymorphisms .


We characterized the interindividual variability in lutein bioavailability in humans , assessed the relation between this variability and the fasting blood lutein concentration , and identified single nucleotide polymorphisms ( SNPs ) involved in this phenomenon .


In a randomized , @-way crossover study , @ healthy men consumed a meal that contained a lutein supplement or the same meal for which lutein was provided through a tomato puree .


The lutein concentration was measured in plasma chylomicrons isolated at regular time intervals over @ h postprandially .


Multivariate statistical analyses were used to identify a combination of SNPs associated with the postprandial chylomicron lutein response ( @-@-h area under the curve ) .


A total of @ SNPs in @ candidate genes were selected .


Postprandial chylomicron lutein responses to meals were very variable ( CV of @ % and @ % for the lutein-supplement meal and the meal with tomato-sourced lutein , respectively ) .


Postprandial chylomicron lutein responses measured after the @ meals were positively correlated ( r = @ , P < @ ) and positively correlated to the fasting plasma lutein concentration ( r = @ , P < @ for the lutein-supplement-containing meal ) .


A significant ( P = @ @ ( -@ ) ) and validated partial least-squares regression model , which included @ SNPs in @ genes , explained most of the variance in the postprandial chylomicron lutein response .


The ability to respond to lutein appears to be , at least in part , genetically determined .


The ability is explained , in large part , by a combination of SNPs in @ genes related to both lutein and chylomicron metabolism .


Finally , our results suggest that the ability to respond to lutein and blood lutein status are related .


This trial was registered at clinicaltrials.gov as NCT@ .


Mindfulness interventions to reduce psychological distress are well-suited to pregnancy , due to their brief and non-pharmacological nature , but there is a need for more robust evidence determining their usefulness .


This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression , anxiety and stress .


The study was designed in two parts @ ) a non-randomised trial targeting women at risk of mental health problems ( a selected population ) and @ ) a randomised controlled trial ( RCT ) of a universal population .


Process evaluation focused on feasibility of recruitment pathways , participant retention , acceptability of study measures , and engagement with mindfulness practices .


Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised , the Depression Anxiety and Stress Scale-@ , the State-Trait Anxiety Inventory , and the Perceived Stress Scale .


@ women were recruited to the non-randomised trial , and @ to the RCT .


Recruitment through a mailed study brochure at the time of booking-in to the hospital resulted in the largest number of participants in the RCT ( @/@ ; @ % ) , and resulted in considerably earlier recruitment ( @ % in first trimester , @ % second trimester ) compared to recruitment through the antenatal clinic waiting room ( @ % in second trimester , @ % third trimester ) .


Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety , indicating a sample with more symptomology than the general population .


The most common reason for loss to follow-up was delivery of baby prior to follow-up ( n = @ ) .


In the non-randomised study , significant within group improvements to depression and anxiety were observed .


In the intervention arm of the RCT there were significant within group improvements to anxiety and mindfulness .


No between group differences for the intervention and ` care as usual ' control group were observed .


This small pilot study provides evidence on the feasibility of an antenatal mindfulness intervention to reduce psychological distress .


Major challenges include : finding ways to facilitate recruitment in early pregnancy and engaging younger women and other vulnerable populations .


Prevention of iron deficiency in infancy may promote neurodevelopment .


Delayed umbilical cord clamping ( CC ) prevents iron deficiency at @ to @ months of age , but long-term effects after @ months of age have not been reported .


To investigate the effects of delayed CC compared with early CC on neurodevelopment at @ years of age .


Follow-up of a randomized clinical trial conducted from April @ , @ , through May @ , @ , at a Swedish county hospital .


Children who were included in the original study ( n = @ ) as full-term infants born after a low-risk pregnancy were invited to return for follow-up at @ years of age .


Wechsler Preschool and Primary Scale of Intelligence ( WPPSI-III ) and Movement Assessment Battery for Children ( Movement ABC ) scores ( collected between April @ , @ , and July @ , @ ) were assessed by a blinded psychologist .


Between April @ , @ , and August @ , @ , parents recorded their child 's development using the Ages and Stages Questionnaire , Third Edition ( ASQ ) and behavior using the Strengths and Difficulties Questionnaire .


All data were analyzed by intention to treat .


Randomization to delayed CC ( @ seconds after delivery ) or early CC ( @ seconds after delivery ) .


The main outcome was full-scale IQ as assessed by the WPPSI-III .


Secondary objectives were development as assessed by the scales from the WPPSI-III and Movement ABC , development as recorded using the ASQ , and behavior using the Strengths and Difficulties Questionnaire .


We assessed @ children ( @ % ) .


No differences were found in WPPSI-III scores between groups .


Delayed CC improved the adjusted mean differences ( AMDs ) in the ASQ personal-social ( AMD , @ ; @ % CI , @-@ @ ) and fine-motor ( AMD , @ ; @ % CI , @-@ @ ) domains and the Strengths and Difficulties Questionnaire prosocial subscale ( AMD , @ ; @ % CI , > @-@ @ ) .


Fewer children in the delayed-CC group had results below the cutoff in the ASQ fine-motor domain ( @ % vs @ % ; P = @ ) and the Movement ABC bicycle-trail task ( @ % vs @ % ; P = @ ) .


Boys who received delayed CC had significantly higher AMDs in the WPPSI-III processing-speed quotient ( AMD , @ ; @ % CI , @-@ @ ; P = @ ) , Movement ABC bicycle-trail task ( AMD , @ ; @ % CI , @-@ @ ; P = @ ) , and fine-motor ( AMD , @ ; @ % CI , @-@ @ ; P = @ ) and personal-social ( AMD , @ ; @ % CI , @-@ @ ; P = @ ) domains of the ASQ .


Delayed CC compared with early CC improved scores in the fine-motor and social domains at @ years of age , especially in boys , indicating that optimizing the time to CC may affect neurodevelopment in a low-risk population of children born in a high-income country .


The Alberta Stroke Program Early CT Score ( ASPECTS ) on baseline imaging is an established predictor of acute ischemic stroke outcomes .


We analyzed change on serial ASPECTS at baseline and @-hour imaging in the Solitaire Flow Restoration with the Intention for Thrombectomy ( SWIFT ) study to determine prognostic value and to identify subgroups with extensive injury after intervention .


ASPECTS at baseline and @ hours was independently scored in all anterior circulation SWIFT cases , blinded to all other trial data .


ASPECTS at baseline , at @ hours , and serial changes were analyzed with univariate and multivariate approaches .


One hundred thirty-nine patients ( mean age , @ -LSB- SD , @ -RSB- years ; @ % women ; median National Institutes of Health Stroke Scale , @ -LSB- interquartile range , @-@ -RSB- ) with complete data at both time points were studied .


Multivariate analyses showed that higher @-hour ASPECTS predicted good clinical outcome ( day @ modified Rankin Scale , @-@ ; odds ratio , @ ; P < @ ) .


Among patients with high baseline ASPECTS ( @-@ ; n = @ ) , dramatic infarct progression ( decrease in ASPECTS @ points at @ hours ) was noted in @ of @ ( @ % ) .


Such serial ASPECTS change was predicted by higher baseline systolic blood pressure ( P = @ ) , higher baseline blood glucose ( P = @ ) , and failure to achieve Thrombolysis in Cerebral Infarction score of @b/@ reperfusion ( P < @ ) , culminating in worse day @ modified Rankin Scale outcomes ( mean modified Rankin Scale , @ versus @ ; P < @ ) .


Twenty-four-hour ASPECTS provides better prognostic information compared with baseline ASPECTS .


Predictors of dramatic infarct progression on ASPECTS are hyperglycemia , hypertension , and nonreperfusion .


Serial ASPECTS change from baseline to @ hours predicts clinical outcome , providing an early surrogate end point for thrombectomy trials .


We tested the hypothesis that direct intramyocardial injection of bone marrow mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve left ventricular function and physical capacity .


Thirty non-ischemic dilated cardiomyopathy patients with left ventricular ejection fraction < @ % were randomized at a @:@ ratio into two groups , control and treated .


The bone marrow mononuclear cells group received @ bone marrow mononuclear cells through mini-thoracotomy .


There was no intervention in the control group .


Assessment was carried out through clinical evaluations as well as a @-min walk test , nuclear magnectic resonance imaging and echocardiogram .


The bone marrow mononuclear cells group showed a trend toward left ventricular ejection fraction improvement , with magnectic resonance imaging - at @ months , showing an increase from @ % to @ % ( P = @ ) and returning to baseline at @ months ( @ % , P = @ ) .


Magnectic resonance imaging showed no changes in left ventricular ejection fraction during follow-up of the control group ( @ % , @ % , and @ % ) .


Echocardiogram showed left ventricular ejection fraction improved in the bone marrow mononuclear cells group at @ months , @ to @ ( P = @ ) , and one year , @ % ( P = @ ) .


The control group showed no change ( @ vs @ and @ % , P = @ and @ , respectively ) .


Bone marrow mononuclear cells group showed improvement in New York Heart Association functional class , from @ to @ ( P = @ ) ; patients in the control group showed no change ( @ to @ ; P = @ ) .


Six-minute walk test improved in the bone marrow mononuclear cells group ( @ m at baseline to @ m at @ months , P = @ ) and there was a non-significant decline in the control group ( @ m to @ m after @ months , P = @ ) .


Group comparisons were non-significant .


The trend of intragroup functional and subjective improvement was not confirmed when compared to the control group .


Direct intramyocardial application of bone marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated with significant changes in left ventricular function .


Differences observed within the bone marrow mononuclear cells group could be due to placebo effect or low statistical power .


The aim of this study was to investigate whether infiltration of the upper eyelid skin is less painful with prilocaine than with lidocaine .


In @ consecutive patients scheduled for bilateral upper blepharoplasty , one upper eyelid was anaesthetised with lidocaine with epinephrine and the other with prilocaine with felypressin .


After injection of each upper eyelid , the patient scored the pain experienced on infiltration using a visual analogue scale ( @-@ ) .


In addition , the surgeon scored the need for reinjection during the operation ; differences in perioperative bleeding ; and degree of oedema , erythema and haematoma before discharge on a four-point rating scale ( no , minimal , moderate or severe ) .


Pain scores were significantly lower in upper eyelids injected with lidocaine than in those injected with prilocaine ( p = @ ) .


In addition , scores for oedema , erythema and haematoma were significantly lower in upper eyelids anaesthetised with lidocaine than in those anaesthetised with prilocaine ( respectively , p = @ , p = @ and p = @ ) .


Compared with prilocaine with felypressin , lidocaine with epinephrine is significantly less painful in anaesthetising the upper eyelids ; gives significantly less postoperative oedema , erythema and haematoma ; and provides better haemostasis during upper blepharoplasty .


This was a level II , randomised double-blinded crossover study .


The aim of this study was to investigate the potential drug-drug interaction between Bencycloquidium bromide ( BCQB ) and paroxetine , and between BCQB and roxithromycin .


Two studies were conducted on healthy male Chinese volunteers .


Study A was an open-label , two-period , one-sequence crossover study ( n = @ ) .


Each participant received a single nasal spray dose of BCQB @g on day @ .


After a @-day wash-out period , subjects received @mg of paroxetine from day @ to @ , and were co-administered @mg of paroxetine and BCQB @g on day @ .


In study B , participants ( n = @ ) were randomly assigned to two groups .


In period I , group A received BCQB @g on day @ , followed by the same dose four times daily from day @ to @ , then , on day @ a single dose of @mg roxithromycin with BCQB @g were co-administered .


In parallel , group B received a single dose of roxithromycin @mg on day @ , followed by @mg of roxithromycin from day @ to @ , then , on day @ a single dose of BCQB @g with roxithromycin @mg were co-administered .


After a wash-out time of @days the respective treatments of each group ( A and B ) were swapped in period II .


Blood samples were collected for pharmacokinetic analysis .


Statistical comparison of pharmacokinetic parameters was performed to identify a possible drug interaction between treatments .


Tolerability was evaluated by recording adverse events .


Study A : Geometric mean AUC@-@ for BCQB alone and co-administered with paroxetine were @ and @ pgh/ml , respectively .


The geometric mean ratio ( GMR ) of AUC@-@ was @ ( @-@ @ ) , @ % C.Is , and was out the predefined bioequivalence interval ( @ % C.Is , @-@ @ ) .


Geometric mean Cmax were @ and @ pg/ml .


Study B : The GMR of AUC@-@ was @ ( @-@ @ ) , @ % C.Is for BCQB , and the GMR of AUC@-@ was @ ( @-@ @ ) , @ % C.Is for roxithromycin .


Both GMRs were within the predefined bioequivalence interval ( @ % C.Is , @-@ @ ) .


Other pharmacokinetic parameters were within the predefined interval .


No serious adverse events were reported and no significant clinical changes were observed in laboratory test results , vital signs and ECGs in any of the studies .


All treatments were well tolerated .


The co-administration of BCQB with paroxetine showed a moderate increase in BCQB exposure , but was not clinically relevant .


Also , no drug interaction was found between BCQB and roxithromycin .


The aim of this study was to determine the safety and efficacy of induction with rabbit antithymocyte globulin ( RATG ) compared with interleukin-@ receptor antagonists in a racially diverse kidney transplant patient population under modern immunosuppression .


The optimal induction therapy in patients at risk for rejection , particularly black recipients , in the modern era of immunosuppression with flow cytometry-based cross-matching is unclear .


This was a prospective , risk-stratified , randomized , single-center , open-label study of @ consecutively enrolled patients in a large academic teaching center .


Patients were randomized to receive either daclizumab or basiliximab versus RATG for induction in combination with tacrolimus , mycophenolate mofetil , and corticosteroids .


Patients were stratified between groups to ensure equal numbers of black , retransplants , high panel reactive antibodies ( PRAs ) ( > @ % ) , and prolonged cold ischemic times ( > @ hours ) in each group .


Primary outcome measure is treatment efficacy defined as the incidence of biopsy-proven acute rejection and estimated creatinine clearance .


Patients were followed up for @ months .


Renal transplant recipients were included if they were adult ( @ years old ) and received an allograft from a deceased , living unrelated , or nonhuman leukocyte antigen identical living-related donor .


A total of @ patients ( n = @ in the interleukin-@ receptor antagonists , and n = @ in the RATG ) were enrolled from February @ through July @ .


One-year acute rejection rates were low and similar between groups ( @ % in the interleukin-@ receptor antagonist group vs @ % in the RATG group ; P = @ ) .


Creatinine clearance was also similar between groups ( interleukin-@ receptor antagonist group @ @ mL/min per @ m@ vs RATG group @ @ mL/min per @ m@ ; P = @ ) .


Subanalysis of recipient race revealed that in blacks only RATG was protective against @ - and @-month acute rejection , without an increased risk of infection .


Induction did not affect rejection rates according to recipient calculated PRAs ; however , RATG was associated with an increased risk of BK virus in low-PRA patients .


RATG induction provides improved protection against early acute rejection in black renal transplant recipients , whereas sensitized patients do not seem to demonstrate a similar benefit from this therapy .


This study is registered at Clinicaltrials.gov ( NCT@ ) .


Postoperative adhesions constitute a substantial clinical problem in hand surgery .


Fexor tendon injury and repair result in adhesion formation around the tendon , which restricts the gliding function of the tendon , leading to decreased digit mobility and impaired hand recovery .


This study evaluated the efficacy and safety of the peptide PXL@ in preventing adhesions , and correspondingly improving hand function , in flexor tendon repair surgery .


This prospective , randomised , double-blind trial included @ patients admitted for flexor tendon repair surgery .


PXL@ in carrier sodium hyaluronate or placebo was administered around the repaired tendon .


Efficacy was assessed by total active motion of the injured finger , tip-to-crease distance , sensory function , tenolysis rate and grip strength , and safety parameters were followed , for @ months post-surgery .


The most pronounced difference between the treatment groups was observed at @ months post-surgery .


At this timepoint , the total active motion of the distal finger joint was improved in the PXL@ group ( @ vs. @ degrees for PXL@ vs. placebo group , p = @ in PPAS ) .


The proportion of patients with excellent/good digit mobility was higher in the PXL@ group ( @ % vs. @ % , p = @ in PPAS ) .


Consistently , the PXL@ group presented improved tip-to-crease distance ( @ vs. @ mm for PXL@ vs. placebo group , p = @ in PPAS ) .


Sensory evaluation showed that more patients in the PXL@ group felt the thinnest monofilaments ( FAS : @ % vs. @ % , p = @ ; PPAS : @ % vs. @ % , p = @ ) .


At @ months post-surgery , more patients in the placebo group were considered to benefit from tenolysis ( @ % vs. @ % , p = @ in PPAS ) .


The treatment was safe , well tolerated , and did not increase the rate of tendon rupture .


Treatment with PXL@ in sodium hyaluronate improves hand recovery after flexor tendon repair surgery .


Further clinical trials are warranted to determine the most efficient dose and health economic benefits .


Free oxygen radicals might have an adverse effect on platelets which might be reflected either on its count and/or degree of bleeding severity .


To assess oxidant-antioxidant systems and evaluate effect of antioxidant therapy on platelet count ( PC ) and bleeding score ( BS ) in children and adolescents with ITP .


Six months prospective randomized single blind study registered as ( NCT @ ) including @ patients with newly diagnosed ( ND ) ITP ; group @ ( G@ ) and @ patients with chronic ITP ( G@ ) , each group was randomly allocated ( @:@ ) to one of two subgroups respectively ; ( G@A and G@A ) interventional arm received daily antioxidant therapy , while G@B and G@B ; received a placebo .


Both groups were compared with healthy controls ( n = @ ) .


The primary efficacy endpoints were the difference in the change from baseline to @ month in ITP specific bleeding assessment tool ( ITP-BAT ) , PC , total antioxidant capacity ( TAC ) , catalase ( CAT ) , reduced glutathione ( GSH ) and serum malondialdehyde ( MDA ) .


Baseline TAC was significantly lower in patients with ( ND ) ITP compared to patients with chronic ITP ( P < @ ) , both showed significantly lower levels than healthy controls ( P < @ ) .


At end of study both BS and PC significantly improved in patients receiving antioxidant compared to placebo ( P < @ ) .


Patients with chronic ITP receiving antioxidant showed better improvement .


Reduced antioxidant mechanisms were reported in patients with ITP .


Antioxidant therapy ameliorated the oxidative stress in both ND and chronic ITP groups which might explain the improvement in both BS and PC .


The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least @ millimeters of articular step-off on at least one radiograph ( defined as displaced ) , but less than @ millimeter of gap between the fragments ( defined as stable ) and that are not associated with an elbow dislocation , interosseous ligament injury , or other fractures .


These kinds of fractures are often classified as Mason type-@ fractures .


Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment , but the long-term results of nonoperative treatment are very good .


Most experts agree that problems like reduced range of motion , painful crepitation , nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head , but determining which patients will have problems is difficult .


A prospective , randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits .


The RAMBO trial ( Radial Head - Amsterdam - Amphia - Boston - Others ) is an international prospective , randomized , multicenter trial .


The primary objective of this study is to compare patient related outcome defined by the ` Disabilities of Arm , Shoulder and Hand ( DASH ) score ' twelve months after injury between operative and nonoperative treated patients .


Adult patients with partial articular fractures of the radial head that comprise at least @/@rd of the articular surface , have @ millimeters of articular step-off but less than @ millimeter of gap between the fragments will be enrolled .


Secondary outcome measures will be the Mayo Elbow Performance Index ( MEPI ) , the Oxford Elbow Score ( OES ) , pain intensity through the ` Numeric Rating Scale ' , range of motion ( flexion arc and rotational arc ) , radiographic appearance of the fracture ( heterotopic ossification , radiocapitellar and ulnohumeral arthrosis , fracture healing , and signs of implant loosening or breakage ) and adverse events ( infection , nerve injury , secondary interventions ) after one year .


The successful completion of this trial will provide evidence on the best treatment for stable , displaced , partial articular fractures of the radial head .


The immunosuppressant tacrolimus is usually administered orally .


When this is not feasible , other routes of administration may be useful .


Previous research suggested that tacrolimus may be applied sublingually or rectally .


Pharmacokinetic data are sparse .


The aim of this study was to investigate and compare the pharmacokinetics of these alternative formulations with orally administered tacrolimus .


Three single , fixed-dose formulations of tacrolimus were administered in a random sequence in @ healthy subjects , using a cross-over study design .


For sublingual administration , @mg of powder obtained from oral capsules was applied under the tongue for a period of @min without swallowing , with mouth rinsing afterwards .


For rectal administration , a suppository containing @mg of the oral powder was used .


Oral administration consisted of @mg of instant-release tacrolimus capsules ( Prograf ) .


Main pharmacokinetic outcome parameters were compared by anova .


Sublingual administration showed no clinically significant exposure , contrary to rectal administration , where all subjects had clinically relevant exposure , with a lower relative bioavailability ( @ % ) , a lower maximal blood concentration and a later time of maximal blood concentration compared with oral administration .


Sublingual administration of a single dose of tacrolimus does not result in systemic exposure if care is taken not to swallow saliva and to rinse the oral cavity afterwards .


Rectal administration of tacrolimus results in clinically relevant systemic exposure and might represent an alternative formulation in case oral administration is not feasible .


When used as a topical agent , systemic side-effects should be considered .


Helicobacter pylori ( Hp ) is a common and potentially curable cause of gastric mucosa lesion .


This study investigated the relationship of Hp infection with histological changes in gastric mucosa and gastric cancer in Hp-positive patients compared with Hp-eradication patients followed up for ten years .


From an initial group of @ @ adults , @ Hp-positive subjects were randomly assigned to a treatment group ( T ; n = @ ) or a placebo group ( P ; n = @ ) .


In the randomized , double-blind , placebo-controlled , parallel trial , T group subjects received oral doses of omeprazole , amoxicillin and clarithromycin for @ week ; those in the P group received a placebo .


One month after treatment ended , a @C urea breath test was performed , and Hp was undetectable in @ % of the T group .


All subjects were followed at @ , @ , @ , and @ years after treatment , with endoscopy and biopsies for histological examination .


Gastric mucosa inflammation was significantly milder in the T group than that in the P group one year after Hp eradication and this persisted for @ years .


Glandular atrophy and intestinal metaplasia ( IM ) had deteriorated in both groups during ten years .


However , the increased score of glandular atrophy at both the gastric antrum and corpus , and IM only at the gastric antrum , in the P group was more obvious than that in the T group .


During the @ years , @ patients were diagnosed with gastric cancer ( @ in the T group ; @ in the P group ; P = @ ) .


When mucosal atrophy was absent at the gastric antrum and corpus when entering the study , the incidence of gastric cancer in the P group ( n = @ ) was much higher than that in the T group ( n = @ , P = @ ) .


Hp eradication may significantly diminish and help halt progression of gastric mucosal inflammation and delay the development of IM and atrophy gastritis .


Hp eradication is helpful for reducing the risk for gastric cancer , especially in the early stage of Hp infection .


Pelvic adhesions are found in up to @ % of women with CPP during investigative surgeries and adhesiolysis is often performed as part of their management although the causal or casual association of adhesions , and the clinical benefit of adhesiolysis in the context of CPP is still unclear .


Our aim was to test the hypothesis of whether laparoscopic adhesiolysis leads to significant pain relief and improvement in quality of life ( QoL ) in patients with chronic pelvic pain ( CPP ) and adhesions .


This was a double-blinded RCT .


This study was conducted in @ tertiary referral hospitals in United Kingdom over @years .


Women with chronic pelvic pain ( CPP ) were randomized into having laparoscopic adhesiolysis or diagnostic laparoscopy .


Women were assessed at @ , @ and @months for Visual analogue scale scores ( VAS ) and Quality of Life ( QoL ) measures ( SF-@ and EHP-@ ) .


A total of @ participants were recruited ; @ qualified to be randomized , with @ in the adhesiolysis and @ in the control group .


The results are expressed in median ( interquartile ranges ) .


In women who underwent adhesiolysis , there was a significant improvement at @months in VAS scores ( -@ ( -@ - -@ ) compared to controls ( -@ ( -@ - @ ; p = @ ) ; SF-@ scores physical component score ( @ ( @ - @ ) ) compared to controls ( @ ( -@ - @ ) ; p = @ ) , SF-@ emotional component score @ ( @ - @ ) compared to controls -@ ( -@ - @ ) ; p < @ ) and EHP-@ emotional well being domain @ ( @ - @ ) compared to the controls -@ ( -@ - @ ; p < @ ) .


This study stopped before recruitment reached the statistically powered sample size due to difficulty with enrollment and lack of continued funding .


In selected population of women presenting to the gynecological clinic with chronic pelvic pain , adhesiolysis in those who have adhesions may be of benefit in terms of improvement of pain and their quality of life .


This study reports the long-term follow-up of the randomised controlled HEBE trial .


The HEBE study is a multicentre trial that randomised @ patients with large first acute myocardial infarction ( AMI ) treated with primary percutaneous coronary intervention to either intracoronary infusion of bone marrow mononuclear cells ( BMMCs ) ( n = @ ) , peripheral blood mononuclear cells ( PBMCs ) ( n = @ ) or standard therapy ( n = @ ) .


In addition to @-@days , and @months after AMI , all patients underwent cardiac MRI after @years .


A follow-up for @years after AMI was performed to assess clinical adverse events , including death , myocardial reinfarction and hospitalisation for heart failure .


Of the @ patients enrolled , @ patients died and @ patients were lost to follow-up at @years after AMI .


BMMC group showed less increase in LV end-diastolic volume ( LVEDV ) ( @ mL/m ( @ ) ) compared with ( @ mL/m ( @ ) , p = @ ) in the control group , with no difference between the PBMC group ( @ mL/m ( @ ) ) and controls ( p = @ ) .


Moreover , the BMMC group showed a trend for decrease in LV end systolic volume ( -@ mL/m ( @ ) ) as compared with controls ( @ mL/m ( @ ) , p = @ ) , with again no difference between PBMC ( @ mL/m ( @ ) ) and controls ( p = @ ) .


The combined endpoint of death and hospitalisation for heart failure was non-significantly less frequent in the BMMC group compared with the control group ( n = @ vs n = @ , p = @ ) , with no difference between PBMC and controls ( n = @ vs n = @ , p = @ ) .


The composite endpoint of death or recurrent myocardial infarction was significantly higher in the PBMC group compared with controls ( @ patients vs @ patients , p = @ ) , with no difference between the BMMC group and controls ( @ vs @ patients , p = @ ) .


Long-term follow-up of the HEBE trial showed that increase in LVEDV was lower in the BMMC group .


This study supports the long-term safety of intracoronary BMMC therapy .


However , major clinical cardiovascular adverse events were significantly more frequent in the PBMC group .


Renal dysfunction is a common comorbidity in patients with heart failure and preserved ejection fraction ( HFpEF ) .


We sought to determine whether renal dysfunction was associated with measures of cardiovascular structure/function in patients with HFpEF .


We studied @ participants from the PARAMOUNT study with HFpEF who had echocardiography and measures of kidney function .


We evaluated the relationships between renal dysfunction -LSB- estimated glomerular filtration rate ( eGFR ) > @ and < @ mL/min/@ @ m ( @ ) and/or albuminuria -RSB- and cardiovascular structure/function .


The mean age of the study population was @ years , @ % were women , @ % hypertensive , and @ % diabetic .


Impairment of at least one parameter of kidney function was present in @ % of patients ( @ % only albuminuria , @ % only low eGFR , @ % both ) .


Renal dysfunction was associated with abnormal LV geometry ( defined as concentric hypertrophy , or eccentric hypertrophy , or concentric remodelling ) ( adjusted P = @ ) , lower midwall fractional shortening ( MWFS ) ( P = @ ) , and higher NT-proBNP ( P = @ ) .


Compared with patients without renal dysfunction , those with low eGFR and no albuminuria had a higher prevalence of abnormal LV geometry ( P = @ ) and lower MWFS ( P < @ ) , as opposed to those with only albuminuria .


Conversely , albuminuria alone was associated with greater LV dimensions ( P < @ ) .


Patients with combined renal impairment had mixed abnormalities ( higher LV wall thicknesses , NT-proBNP ; lower MWFS ) .


Renal dysfunction , as determined by both eGFR and albuminuria , is highly prevalent in HFpEF , and associated with cardiac remodelling and subtle systolic dysfunction .


The observed differences in cardiac structure/function between each type of renal damage suggest that both parameters of kidney function might play a distinct role in HFpEF .


The purpose of this study was to compare the safety and efficacy of a new cationic emulsion ( CE ) with a formulation of polyvinyl alcohol and povidone ( PVA-P ) for the treatment of mild to moderate dry eye disease .


This was a multicenter , open-label , comparative study .


Patients were randomised to receive CE ( Cationorm ) or PVA-P ( Refresh ) ( @:@ ) .


The following objective criteria were assessed to compare the two eye drops : tear Break-up Time ( TBUT ) , Schirmer 's test , lissamine green staining ( Van Bijsterveld score ) , corneal fluorescein staining ( Oxford scale ) and oculopalpebral examination , on D@ and D@ ( end of study ) .


At these visits , ocular symptoms and safety were also assessed .


Seventy-nine patients were randomised : CE : @ patients ; PVA-P : @ patients .


At D@ , improvement was significantly better for TBUT -LSB- CE : @ @ s ; PVA-P : @ @ s ; P = @ -RSB- and for the Van Bijsterveld score -LSB- CE : -@ @ ; PVA-P : -@ @ ; P = @ -RSB- in the CE group .


The same applied for the palpebral erythema score ( P = @ ) , overall efficacy assessed by the investigators ( P < @ ) , and symptoms not related to eye drop instillation ( P = @ ) .


Improvement was observed from D@ .


No difference was observed between the two treatments with regard to ocular safety .


These results suggest that in patients with mild to moderate dry eye , Cationorm , in addition to its moisturizing and lubricating properties , also helps stabilize the tear film due to its oily component .


This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease .


The EndoFlex is a new type of tracheal tube with an adjustable distal tip that can be bent without the use of a stylet .


The aim of this study was to compare a standard endotracheal tube with the EndoFlex tracheal tube for intubation in patients with simulated cervical spine injury .


A group of @ patients without any kind of the cervical spine injury , classified as the ASA physiological scale I or II and qualified for elective surgery procedures were intubated with the use of classical Macintosh laryngoscope , and either a standard endotracheal tube with the intubation stylet in it or EndoFlex tube without stylet .


The subjects were randomized into two subgroups .


All patients have had the cervical collar placed on their neck for the simulation of intubation procedure in case of the spinal injury .


The intubation procedure was performed by @ anesthetists with different experience ( @-@ yrs ) .


Time of intubation with the use of EndoFlex tube was similar to that with a the use of standard endotracheal tube and intubation stylet : Me ( median ) @ s -LSB- IQR ( interquatile range ) @-@ -RSB- vs. Me @ s -LSB- IQR @-@ -RSB- respectively ( p = @ ) .


No significant additional maneuvers were necessary during intubation with the use of EndoFlex tube in comparison with standard endotracheal tube ( @ % vs. @ % ) ( p = @ ) .


Subjective assessment of the usability of both tubes revealed that more anesthesiologists found intubations with the use of EndoFlex more demanding than intubation with conventional tracheal tube and intubation stylet .


The assessment of usability : very easy @ % vs. @ % , easy @ % vs. @ % , difficult @ % vs. @ % and very difficult @ % vs. @ % for standard endotracheal tube with stylet and EndoFlex , respectively .


In conclusion we asses , that the EndoFlex tube does not improve intubation success rate , in fact it requires more maneuvers facilitating intubation and was found to be more difficult to use .


The present study evaluated the efficacy of preoperative pregabalin for prevention of catheter-related bladder discomfort .


Prospective , randomized , placebo controlled , double blinded study .


Sixty patients of either sex undergoing elective spine surgery and requiring urinary bladder catheterization were randomly assigned to two groups .


The patients in Group P ( pregabalin group ) received @mg of pregabalin orally @h prior to induction of anesthesia with sips of water and the patients in Group C ( control group ) received placebo .


Anesthesia technique was identical in both the groups .


Catheter-related bladder discomfort ( CRBD ) was evaluated on a @-point scale ( @ = no discomfort , @ = mild , @ = moderate , @ = severe ) , on arrival ( @h ) and again at @ , @ , and @h postoperatively .


Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief .


The incidence of CRBD was significantly less in the pregabalin group compared with the control group at all time intervals ( P < @ ) .


The severity of CRBD was reduced in the pregabalin group compared with the control group at all time intervals except @h .


The postoperative consumption of fentanyl was significantly less in group P , while the sedation score was significantly higher in the group P compared to group C.


Pretreatment with pregabalin @mg prevents CRBD and also decreases postoperative fentanyl consumption .


Clinical Trials.gov identifier : ( ref : CTRI/@/@ / @ ) .


Many patients report discomfort because of the unpleasant taste of bowel preparation solutions .


This study aimed to determine whether adding orange juice to @ L of polyethylene glycol plus ascorbic acid is effective for reducing patient discomfort and improving palatability during bowel preparation .


This was a single-blinded , randomized controlled trial .


The study was conducted at a tertiary referral hospital and a generalized hospital .


Consecutive outpatients and inpatients were randomly allocated to drink @ L of polyethylene glycol-ascorbic acid or @ L of polyethylene glycol-ascorbic acid with orange juice in a single dose or a split dose .


Tolerability , palatability score , willingness , and related adverse events were investigated by questionnaires .


Bowel cleansing was rated using the Aronchick scale .


Each score was graded on a @-point scale .


A total of @ patients , @ in the orange juice group and @ in the polyethylene glycol-ascorbic acid group who underwent elective colonoscopy were enrolled .


The palatability score ( mean SD ) was higher in the orange juice group than in the control group ( @ @ vs @ @ ; p = @ ) .


Nausea was less frequent in the orange juice group ( @ % vs @ % ; p = @ ) .


Total amount of bowel preparation ingested was not significantly different between the groups ( p = @ ) .


The bowel preparation score ( mean SD ) was not significantly different ( @ @ vs @ @ ; p = @ ) .


Willingness to repeat the same process was higher in the orange juice group ( @ % vs @ % ; p = @ ) .


This study is limited because only ambulatory patients were enrolled .


Orange juice intake before drinking @ L of polyethylene glycol-ascorbic acid for colonoscopy can reduce patient discomfort , resulting in improved acceptability and patient compliance .


This method is as effective for bowel cleansing as polyethylene glycol .


We compared the angiotensin receptor-neprilysin inhibitor LCZ@ with enalapril in patients who had heart failure with a reduced ejection fraction .


In previous studies , enalapril improved survival in such patients .


In this double-blind trial , we randomly assigned @ patients with class II , III , or IV heart failure and an ejection fraction of @ % or less to receive either LCZ@ ( at a dose of @ mg twice daily ) or enalapril ( at a dose of @ mg twice daily ) , in addition to recommended therapy .


The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure , but the trial was designed to detect a difference in the rates of death from cardiovascular causes .


The trial was stopped early , according to prespecified rules , after a median follow-up of @ months , because the boundary for an overwhelming benefit with LCZ@ had been crossed .


At the time of study closure , the primary outcome had occurred in @ patients ( @ % ) in the LCZ@ group and @ patients ( @ % ) in the enalapril group ( hazard ratio in the LCZ@ group , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


A total of @ patients ( @ % ) receiving LCZ@ and @ patients ( @ % ) receiving enalapril died ( hazard ratio for death from any cause , @ ; @ % CI , @ to @ ; P < @ ) ; of these patients , @ ( @ % ) and @ ( @ % ) , respectively , died from cardiovascular causes ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) .


As compared with enalapril , LCZ@ also reduced the risk of hospitalization for heart failure by @ % ( P < @ ) and decreased the symptoms and physical limitations of heart failure ( P = @ ) .


The LCZ@ group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment , hyperkalemia , and cough than the enalapril group .


LCZ@ was superior to enalapril in reducing the risks of death and of hospitalization for heart failure .


( Funded by Novartis ; PARADIGM-HF ClinicalTrials.gov number , NCT@ . )


This study was conducted to determine the effects of folate supplementation on metabolic profiles in obese women with polycystic ovary syndrome ( PCOS ) .


This randomized double-blind placebo-controlled clinical trial was conducted among @ obese women ( weight range : @-@ kg ) aged @-@ year old diagnosed with PCOS .


Participants were randomly assigned to three groups receiving : ( @ ) Folate-@ : @ mg/day folate supplements ( n = @ ) ; ( @ ) Folate-@ : @ mg/day folate supplements ( n = @ ) , and ( @ ) placebo ( n = @ ) for @ weeks .


Fasting blood samples were taken at baseline and after @ weeks ' intervention to quantify glucose metabolism and lipid concentrations .


Folate supplementation ( @ mg ) , compared with folate-@ and placebo , resulted in reduced plasma homocysteine ( p-interaction = @ ) , homeostasis model of assessment-insulin resistance score ( p-interaction = @ ) , and total cholesterol/HDL-C ratio ( p-interaction = @ ) .


Furthermore , we found a significant difference in mean change of serum total cholesterol ( p-interaction = @ ) , LDL - ( p-interaction = @ ) , and non-HDL-cholesterol levels ( p = @ ) in the folate-@ group compared with folate-@ and placebo .


@ mg/day folate supplementation for @ weeks among women with PCOS had beneficial effects on metabolic profiles .


Patients with Pulmonary Tuberculosis ( PTB ) often develop impairment in pulmonary function due to anatomical changes secondary to the illness .


Physiotherapy in the form of pulmonary rehabilitation has been advocated .


The aim of the study was to determine whether adherence to a six-week home-based pulmonary rehabilitation programme ( PRP ) improved the baseline measurements of lung function , exercise tolerance and health-related quality of life ( HRQoL ) in patients receiving out-patient treatment for PTB .


A single blinded randomized control study design was used to assess the effects of a six-week home - based PRP in patients receiving treatment for PTB at a local clinic in Khayelitsha , Western Cape .


We evaluated lung function by spirometry ( MINATO AUTOSPIRO-model no .


AZ-@ ) , exercise tolerance using the @-min-walk test ( @MWT ) , the Borg exercise exertion scale and HRQoL using the EQ-@ D questionnaire in an intervention group ( n = @ ) and a control group ( n = @ ) .


The trend of the effects of the PRP on lung function was towards increases , but there was no statistical difference between the intervention and control groups at the end of the sixth week in the values of FVC ( p = @ ; @ % CI -@ to @ ) as well as FEV@ ( p = @ ; @ % CI -@ to @ ) .


Similar trend was observed for exercise tolerance , and there was no significant difference in HRQoL ( p = @ ) .


The outcome of the study provides motivation for further consideration and implementation of a pulmonary rehabilitation programme for patients with PTB .


Although the potential advantages of the Endocut mode ( E-mode ) of endoscopic sphincterotomy ( EST ) over the conventional blended cut mode ( C-mode ) have been reported , the problems , including the small sample size and retrospective analysis , that occurred in previous studies make it difficult to conclude the advantage of the E-mode regarding the safety and efficacy .


We performed a prospective randomized controlled study to compare these modes .


A total of @ patients with choledocholithiasis or stenosis of the bile duct were randomly assigned to one of the modes .


To avoid the technical bias due to multiple operators or institutions , the main operator and the institution were restricted to only one experienced doctor and @ institutions at his place of employment , respectively .


We defined pancreatitis , bleeding , and perforation as complications of EST. .


Besides , bleeding includes endoscopically evident bleeding that was defined as visible during the procedure of sphincterotomy and temporary slight oozing .


The complications occurred in @ ( @ % ) patients from the E-mode group : pancreatitis in @ ( @ % ) and endoscopically evident bleeding in @ ( @ % ) .


In contrast , the complications occurred in @ ( @ % ) patients from the C-mode group : pancreatitis in @ ( @ % ) and endoscopically evident bleeding in @ ( @ % ) , although these findings were not statistically significant .


Overall , there were no severe complications .


There were no significant differences in completion ratio of EST and the time taken for the sphincterotomy between both groups .


The E-mode could not surpass the C-mode in safety and efficacy under the operation by a single endoscopist .