This technological advance has the potential to improve the standardization and reproducibility of interpretation of advanced imaging and extend use to practice settings beyond highly specialized academic centers .


home visits and telephone calls are two often used approaches in transitional care , but their differential economic effects are unknown .


to examine the differential economic benefits of home visits with telephone calls and telephone calls only in transitional discharge support .


cost-effectiveness analysis conducted alongside a randomised controlled trial ( RCT ) .


patients discharged from medical units randomly assigned to control ( control , N = @ ) , home visits with calls ( home , N = @ ) and calls only ( call , N = @ ) .


cost-effectiveness analyses were conducted from the societal perspective comparing monetary benefits and quality-adjusted life years ( QALYs ) gained .


the home arm was less costly but less effective at @ days and was dominating ( less costly and more effective ) at @ days .


The call arm was dominating at both @ and @ days .


The incremental QALY for the home arm was -@ / @ ( @/@ days ) , and the call arm was @ / @ ( @/@ days ) .


When the three groups were compared , the call arm had a higher probability being cost-effective at @ days but not at @ days ( home : @ % , call : @ % ( @ days ) versus home : @ % , call : @ % ( @ days ) ) measuring against the NICE threshold of @,@ .


the original RCT showed that the bundled intervention involving home visits and calls was more effective than calls only in the reduction of hospital readmissions .


This study adds a cost perspective to inform policymakers that both home visits and calls only are cost-effective for transitional care support , but calls only have a higher chance of being cost-effective for a sustained period after intervention .


We conducted a phase @ trial in patients with locally advanced cervical cancer by injecting @ ml of the CK@-antagonist CIGB-@ in two different sites on tumours to assess tumour uptake , safety , pharmacodynamic activity and identify the recommended dose .


Fourteen patients were treated with intralesional injections containing @ or @ mg of CIGB-@ in three alternate cycles of three consecutive days each before standard chemoradiotherapy .


Tumour uptake was determined using ( @ ) Tc-radiolabelled peptide .


In situ B@/nucleophosmin was determined by immunohistochemistry .


Maximum tumour uptake for CIGB-@ @-mg dose was significantly higher than the one observed for @ mg : @ @ vs @ @ mg ( P = @ ) .


Both , AUC@h and biological half-life were also significantly higher using @ mg of CIGB-@ ( P < @ ) .


Unincorporated CIGB-@ diffused rapidly to blood and was mainly distributed towards kidneys , and marginally in liver , lungs , heart and spleen .


There was no DLT and moderate allergic-like reactions were the most common systemic side effect with strong correlation between unincorporated CIGB-@ and histamine levels in blood .


CIGB-@ , @ mg , downregulated B@/nucleophosmin ( P = @ ) in tumour specimens .


Intralesional injections of @ mg CIGB-@ in two sites ( @ ml per injection ) and this treatment plan are recommended to be evaluated in phase @ studies .


To determine whether circular plastic wound edge protectors ( CWEPs ) significantly reduce the rate of surgical site infections ( SSIs ) in comparison to standard surgical towels in patients undergoing laparotomy .


SSIs cause substantial morbidity , prolonged hospitalization , and costs and remain one of the most frequent surgical complications .


CWEPs have been proposed as a measure to reduce the incidence of SSIs .


In this randomized controlled , multicenter , @-arm , parallel-group design , patient - and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels .


Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a @-day postoperative period .


Between September @ and November @ , @ patients undergoing laparotomy were randomized at @ centers across Germany .


Three patients in the device group and @ patients in the control group did not undergo laparotomy .


Patients ' and procedural characteristics were well balanced between the @ groups .


Forty-eight patients discontinued the study prematurely , mainly because of relaparotomy ( control , n = @ ; intervention , n = @ ) and death ( control , n = @ ; intervention , n = @ ) .


A total of @ patients experienced SSIs within @ days of surgery , @ of @ ( @ % ) in the device group and @ of @ ( @ % ) in the control group ( odds ratio = @ , @ % confidence interval : @-@ @ ; P = @ ) .


Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery , and in clean-contaminated/contaminated surgeries .


Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery .


To evaluate the curative effect of external application of the Chinese drug , Sanjierupi Gao , on mastalgia caused by mammary gland hyperplasia .


This randomized , double-blinded , and placebo controlled study enrolled @ patients with mammary gland hyperplasia from five hospitals .


Patients were randomly and equally divided into a Sanjierupi Gao treatment group and a placebo control group .


An adhesive plaster was applied to the most painful area on either breast for @ h a day .


Treatment lasted for two menstrual cycles without application during menstruation .


Mastalgia was used as the main index of curative effect .


The change before and after treatment in days of mastalgia , the time to alleviate pain , pain extent , and severe pain scores were observed .


Compared to the control group , the treatment group had significantly fewer days of mastalgia ( P < @ ) , a significantly lower severe pain score ( P < @ ) , and significantly less subjective pain and tenderness ( P < @ and P < @ , respectively ) .


Three days before the follow-up visit , the pain score in the treatment group was significantly lower than that in the control group ( P < @ ) .


A non-parametric test was used to compare the time to alleviate mastalgia between the two groups and found no statistical difference ( Z = -@ , P = @ ) .


Application of Sanjierupi Gao can decrease mastalgia duration in patients with mammary gland hyperplasia during menstruation and alleviate the extent of mastalgia .


The time to alleviate pain is psychologically influenced .


To compare the effect of two manual therapy techniques , mobilization with movement ( WB-MWM ) and talocrural manipulation ( HVLA ) , for the improvement of ankle dorsiflexion in people with chronic ankle instability ( CAI ) over @ h.


Randomized controlled clinical trial .


University research laboratory .


Fifty-two participants ( mean SD age , @ @ years ) with CAI were randomized to WB-MWM ( n = @ ) , HVLA ( n = @ ) or placebo group ( n = @ ) .


Weight-bearing ankle dorsiflexion measured with the weight-bearing lunge .


Measurements were obtained prior to intervention , immediately after intervention , and @ min , @ h and @ h post-intervention .


There was a significant effect time ( F@ ,@ = @ ; P < @ ) and a significant time group interactions ( F@ ,@ = @ ; P < @ ) .


Post hoc analysis showed a significant increase of ankle dorsiflexion in both WB-MWM and HVLA groups with respect to the placebo group with no differences between both active treatment groups .


A single application of WB-MWM or HVLA manual technique improves ankle dorsiflexion in people with CAI , and the effects persist for at least two days .


Both techniques have similar effectiveness for improving ankle dorsiflexion although WB-MWM demonstrated greater effect sizes .


This cross-sectional study examined whether growth parameters were associated with epilepsy in children living in a rural community in sub-Saharan Africa ( SSA ) .


A cross-sectional study was performed in the Hai District Demographic Surveillance Site ( HDSS ) , Tanzania in which @-@ year old children with epilepsy ( CWE ) were identified .


Age matched controls were randomly selected from the Hai census database for comparison .


Anthropometric measurements were used to assess the nutritional status of the children and body mass index ( BMI ) calculated .


Associations between social , demographic and nutritional factors and epilepsy were assessed using multivariable logistic regression .


@ CWE were identified and were compared with @ controls .


There was no significant difference in the BMI between cases and controls ( T-test , p-value of @ ) .


Amongst cases , there were no significant associations between BMI and motor difficulties , antiepileptic drug use , cognitive or behavioural problems , early-onset epilepsy or seizure frequency .


In the whole group , BMI was significantly associated with socio-economic status ( p = @ ) and age .


There was no significant difference found between CWE and matched controls with respect to nutritional status .


This suggests that there is no causal association between under nutrition and epilepsy in this community .


Nutritional assessment is still important as part of the comprehensive care of CWE .


The objective of this study was to evaluate the effects of an exercise program focusing on muscle stretching and endurance training on the @-month incidence of low back pain ( LBP ) in office workers .


A @-month prospective cluster-randomized controlled trial was conducted in healthy office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance .


Healthy office workers ( n = @ ) were randomly assigned at the cluster level into either intervention ( n = @ ) or control ( n = @ ) groups .


Participants in the intervention group received an exercise program that included daily stretching exercise and twice-a-week muscle endurance training .


Those in the control group received no intervention .


The @-month incidence of LBP was the primary outcome .


Secondary outcome were pain intensity , disability level , and quality of life and health status .


Analyses were performed using the Cox proportional hazard models .


Over the @-month follow-up , @ % of participants in the intervention group and @ % in the control group developed incidence of LBP .


Hazard rate ratios showed a protective effect of the exercise program for LBP ( HR = @ , @ % CI @-@ @ ) after adjusting for biopsychosocial factors .


There was no significant difference in pain intensity , disability , and quality of life and health status between those who reported incidence of LBP in the intervention and control groups .


An exercise program consisting of muscle stretching and endurance training is an effective intervention to reduce incident LBP for office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance .


Surgical treatment for displaced proximal humeral fractures is widely used .


However , there are very few randomized controlled studies comparing surgical treatment to conservative treatment , and the evidence is debated .


The aim of this study was to describe patients with displaced proximal humeral fractures in a @-years extension of a randomized controlled trial , their functional outcome and quality of life .


Patients from a single-center randomized controlled study of fifty patients aged @ or above with displaced proximal humeral fracture ( AO/OTA group B@ or C@ ) were randomized to surgical or conservative treatment .


Surgery was performed with an angular stable implant .


The main outcome was Constant score at @-year follow-up .


Secondary outcomes were an ASES self-assessment form , the @D quality of life assessment and radiographs at @ years .


A marked improvement of shoulder function and health-related quality of life for both surgically and conservatively treated patients occurs between @ and @ months .


Almost no change was observed between @ and @ year .


There were no significant differences between the two treatments at @-year follow-up .


In this randomized controlled trial , surgical treatment proved no better results than conservative treatment for patients with displaced proximal humeral fracture at @-year follow-up .


Workers without a permanent employment contract represent a vulnerable group within the working population .


Mental disorders are a major cause of sickness absence within this group .


Common mental disorders are stress-related , depressive and anxiety disorders .


To date , little attention has been paid to effective return to work interventions for this type of sick-listed workers .


Therefore , a participatory supportive return to work program has been developed .


It combines elements of a participatory return to work program , integrated care and direct placement in a competitive job.The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual .


The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions , resulting in a consensus based action plan .


This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency .


During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.Workers eligible to participate in this study have no permanent employment contract , have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.The primary outcome measure is the duration until first sustainable return to work in a competitive job .


Outcomes are measured at baseline and after three , six , nine and twelve months .


If the participatory supportive return to work program proves to be cost-effective , the social security system , the sick-listed worker and society as a whole will benefit .


A cost-effective return to work program will lead to a reduction of costs related to sickness absence .


For the sick-listed worker a cost-effective program results in earlier sustainable return to work , which can be associated with both social and health benefits .


Mounting evidence suggests that high-fidelity mannequin-based ( HFMBS ) and computer-based simulation are useful adjunctive educational tools for advanced cardiac life support ( ACLS ) instruction .


We sought to determine whether access to a supplemental , online computer-based ACLS simulator would improve students ' performance on a standardized Mega Code using high-fidelity mannequin based simulation ( HFMBS ) .


Sixty-five third-year medical students were randomized .


Intervention group subjects ( n = @ ) each received a two-week access code to the online ACLS simulator , whereas the control group subjects ( n = @ ) did not .


Primary outcome measures included students ' time to initiate chest compressions , defibrillate ventricular fibrillation , and pace symptomatic bradycardia .


Secondary outcome measures included students ' subjective self-assessment of ACLS knowledge and confidence .


Students with access to the online simulator on average defibrillated ventricular fibrillation in @ seconds , whereas those without defibrillated in @ seconds , an average of @ seconds faster -LSB- p < @ -RSB- .


Similarly , those with access to the simulator paced symptomatic bradycardia on average in @ seconds whereas those without access paced on average @ seconds a difference of @ seconds -LSB- p < @ -RSB- .


On a subjective @-point scale , there was no difference in self-assessment of ACLS knowledge between the control ( mean @ ) versus intervention ( mean @ ) -LSB- p-value = @ -RSB- .


Despite having outperformed the control group subjects in the standardized Mega Code test scenario , the intervention group felt less confident on a @-point scale ( mean @ ) than the control group .


( mean @ ) -LSB- p < @ -RSB- .


The reduction in time to defibrillate ventricular fibrillation and to pace symptomatic bradycardia among the intervention group subjects suggests that the online computer-based ACLS simulator is an effective adjunctive ACLS instructional tool .


Studies comparing operative with nonoperative treatment of a stable burst fracture of the thoracolumbar junction in neurologically intact patients have not shown a meaningful difference at early follow-up .


To our knowledge , longer-term outcome data have not before been presented .


From @ to @ , forty-seven consecutive patients with a stable thoracolumbar burst fracture and no neurological deficit were evaluated and randomized to one of two treatment groups : operative treatment ( posterior or anterior arthrodesis ) or nonoperative treatment ( a body cast or orthosis ) .


We previously reported the results of follow-up at an average of forty-four months .


The current study presents the results of long-term follow-up , at an average of eighteen years ( range , sixteen to twenty-two years ) .


As in the earlier study , patients at long-term follow-up indicated the degree of pain on a visual analog scale and completed the Roland and Morris disability questionnaire , the Oswestry Disability Index ( ODI ) questionnaire , and the Short Form-@ ( SF-@ ) health survey .


Work and health status were obtained , and patients were evaluated radiographically .


Of the original operatively treated group of twenty-four patients , follow-up data were obtained for nineteen ; one patient had died , and four could not be located .


Of the original nonoperatively treated group of twenty-three patients , data were obtained for eighteen ; two patients had died , and three could not be located .


The average kyphosis was not significantly different between the two groups ( @ for those who received operative treatment compared with @ for those treated nonoperatively ) .


Median scores for pain ( @ cm for the operative group and @ cm for the nonoperative group ; p = @ ) , ODI scores ( @ for the operative group and @ for the nonoperative group ; p < @ ) and Roland and Morris scores ( @ for the operative group and @ for the nonoperative group ; p = @ ) were all significantly better in the group treated nonoperatively .


Seven of eight SF-@ scores also favored nonoperative treatment .


While early analysis ( four years ) revealed few significant differences between the two groups , at long-term follow-up ( sixteen to twenty-two years ) , those with a stable burst fracture who were treated nonoperatively reported less pain and better function compared with those who were treated surgically .


To evaluate the role of sonography ( US ) in assessing hypopharyngeal carcinoma when compared with CT. .


A randomized prospective study was performed on @ biopsy-proven cases of hypopharyngeal carcinoma.Contrast-enhanced CT of the neck was performed in all patients , followed by US .


Sonographic identification of any tumor extension into the extralaryngeal soft tissues , postcricoid space , subglottis , thyroid gland , esophagus , and across the midline was recorded .


US observations and CT findings were compared and then correlated with the histopathologic findings in @ operative cases .


In the remaining @ inoperable cases , US was compared only with CT. .


Our cohort was composed of @ men and @ women ranging in age from @ to @ years .


In a subset of @ operative patients , US had a sensitivity of @ % ( @/@ ) , while CT achieved a sensitivity of @ % ( @/@ ) , and the difference was not statistically significant ( p > @ ) .


US and CT findings concurred in @ % ( @/@ ) of cases .


Even though small tumors are difficult to visualize , US can play a significant role in the assessment of tumor extension within and beyond the larynx , especially when cross-sectional imaging is either unavailable or unaffordable .


We investigated the effects of the fatty acid-bile acid conjugate @-arachidyl-amido , @-@-dihydroxy , @-cholan-@-oic acid ( Aramchol ; Trima Israel Pharmaceutical Products Ltd , Maabarot , Israel ) in a phase @ trial of patients with nonalcoholic fatty liver disease ( NAFLD ) .


We performed a randomized , double-blind , placebo-controlled trial of @ patients with biopsy-confirmed NAFLD ( @ with nonalcoholic steatohepatitis ) at @ centers in Israel .


Patients were given Aramchol ( @ or @ mg ) or placebo once daily for @ months ( n = @/group ) .


The main end point was the difference between groups in the change in liver fat content according to magnetic resonance spectroscopy .


The secondary end points focused on the differences between groups in alterations of liver enzyme levels , levels of adiponectin , homeostasis model assessment scores , and endothelial function .


No serious or drug-related adverse events were observed in the @ patients who completed the study .


Over @ months , liver fat content decreased by @ % @ % in patients given @ mg/day Aramchol , but increased by @ % @ % in the placebo group ( P = @ for the difference between groups , adjusted for age , sex , and body mass index ) .


Liver fat content decreased in the @-mg Aramchol group , by @ % @ % , but this change was nonsignificant ( P = @ ) , indicating a dose-response relationship ( P for trend = @ ) .


Groups given Aramchol had nonsignificant improvements over time in endothelial function and levels of alanine aminotransferase and adiponectin , but homeostasis model assessment scores did not change .


The appropriateness of a single daily dose was confirmed by pharmacokinetic analysis .


Three months ' administration of the fatty acid-bile acid conjugate Aramchol is safe , tolerable , and significantly reduces liver fat content in patients with NAFLD .


The reduction in liver fat content occurred in a dose-dependent manner and was associated with a trend of metabolic improvements , indicating that Aramchol might be used for the treatment of fatty liver disease .


ClinicalTrials.gov number : NCT@ .


The @-HT@ receptor agonist prucalopride is a prokinetic drug which improves colonic motility .


Animal data and in vitro studies suggest that prucalopride also affects gastric and esophageal motor function .


We aimed to assess the effect of prucalopride on gastric emptying , esophageal motility , and gastro-esophageal reflux in man .


In this double-blind , placebo-controlled , randomized , crossover study , we included @ healthy volunteers who received @mg prucalopride or placebo per day for @days .


We performed high-resolution manometry ( HRM ) followed by @-min HRM-pH-impedance monitoring after a standardized meal , ambulatory @-h pH-impedance monitoring , and gastric emptying for solids .


Prucalopride decreased ( median -LSB- IQR -RSB- ) total acid exposure time ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- % , p < @ ) .


The total number of reflux events was unaffected by prucalopride , however , the number of reflux events extending to the proximal esophagus was reduced by prucalopride ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- , p < @ ) .


Furthermore , prucalopride improved acid clearance time ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- s , p < @ ) .


Prucalopride did not affect the number of transient lower esophageal sphincter ( LES ) relaxations or their association with reflux events .


Esophageal motility and basal pressure of the LES were not affected by prucalopride .


Prucalopride increased gastric emptying ( T@/@ ; @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- min , p < @ ) and decreased residue after @min ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- % , p < @ ) .


Prucalopride reduces esophageal acid exposure and accelerates gastric emptying in healthy male volunteers .


These findings suggest that the drug could be effective for treatment of patients with reflux disease and functional dyspepsia .


The primary therapeutic goals in ulcerative colitis ( UC ) are to maintain excellent quality of life ( QOL ) by treating flare-ups when they occur , and preventing flare-ups .


Since stress can trigger UC flare-ups , we investigated the efficacy of mindfulness-based stress reduction ( MBSR ) to reduce flare-ups and improve QOL .


Patients with moderately severe UC , in remission , were randomized to MBSR or time/attention control .


Primary outcome was disease status .


Secondary outcomes were changes in markers of inflammation and disease activity , markers of stress and psychological assessments .


@ subjects were randomized .


Absence of flares , time to flare and severity of flare over @ year were similar between the two groups .


However , post hoc analysis showed that MBSR decreased the proportion of participants with at least one flare-up among those with top tertile urinary cortisol and baseline perceived stress ( @ vs. @ % ; p < @ ) .


MBSR patients who flared demonstrated significantly lower stress at the last visit compared to flared patients in the control group ( p = @ ) .


Furthermore , MBSR prevented a drop in the Inflammatory Bowel Disease Quality of Life Questionnaire during flare ( p < @ ) .


MBSR did not affect the rate or severity of flare-ups in UC patients in remission .


However , MBSR might be effective for those with high stress reactivity ( high perceived stress and urinary cortisol ) during remission .


MBSR appears to improve QOL in UC patients by minimizing the negative impact of flare-ups on QOL .


Further studies are needed to identify a subset of patients for whom MBSR could alter disease course .


Monitoring patient-reported symptoms is necessary to adjust and improve supportive care during chemotherapy .


Continuing advances in computerized approaches to symptom monitoring can enhance communication about unrelieved symptoms between patients and oncology providers and may facilitate intensified symptom treatment .


An automated IT-based telephone monitoring system was developed to enable oncology providers to receive and act on alert reports from patients about unrelieved symptoms during chemotherapy treatment .


Daily , @ participants ( randomized to treatment or attentional control ) were asked to call the automated system to report presence , severity , and distress for common chemotherapy-related symptoms ( @-@ scale if present ) .


For the treatment group , symptoms exceeding preset thresholds for moderate-to-severe intensity levels generated emailed alert reports to both the patient 's oncologist and oncology nurse .


Patients reported high satisfaction and ease of use of the automated system .


Over @ % of providers reported usefulness of the symptom alert reports .


Ten monitored symptoms resulted in , on average , nine moderate-to-severe intensity alerts per patient over @ study days .


However , providers rarely contacted patients after receiving alerts .


There were no significant differences in change of symptom severity between the two groups ( mean difference = @ , p = @ ) .


Despite patients ' use of a daily symptom monitoring system and providers ' receipt of information about unrelieved symptoms of moderate-to-severe intensity , oncology physicians and nurses did not contact patients to intensify symptom treatment nor did symptoms improve .


Further research is indicated to determine if oncology providers initiated follow-up to intensify symptom treatment , whether symptom outcomes would improve .


To compare the influence of femtosecond lenticule extraction ( FLEx ) and small incision lenticule extraction ( SMILE ) on corneal nerve density and the ocular surface for equivalent degrees of correction of myopia .


Sixty eyes of @ patients ( @ males and @ females , mean age : @ @ years ) were included in the study .


The patients underwent FLEx in @ eye and SMILE in the other eye by random assignment .


Subbasal nerve density was measured using confocal microscopy preoperatively and at @ week , @ and @ months , and @ year postoperatively .


Ocular surface parameters such as Schirmer 's test results , tear film break-up time , and corneal sensation were performed preoperatively and at @ and @ months postoperatively .


In the FLEx group , subbasal nerve density was @,@ @,@ m/mm ( @ ) preoperatively and @,@ @,@ m/mm ( @ ) at @ year postoperatively ( P < @ , Dunnett 's test ) .


In the SMILE group , subbasal nerve density was @,@ @,@ m/mm ( @ ) preoperatively and @,@ @,@ m/mm ( @ ) at @ year postoperatively ( P = @ ) .


The decrease in corneal nerve density was significantly less after SMILE than after FLEx at all postoperative visits ( Mann-Whitney U test , P < @ ) .


FLEx resulted in a significant decrease in Schirmer 's test results , tear film break-up time , and corneal sensation at all postoperative visits , whereas SMILE induced no significant changes in these parameters ( P > @ ) .


There was less damage to the sub-basal nerve plexus of the cornea and less effect on the ocular surface parameters after SMILE than after FLEx .


To compare statics characteristics between anterior transpedicular screws ( ATPS ) system and vertebral body screws ( VBS ) system in lower cervical spine .


Sixteen fresh cervical specimens were collected and dissected into @ different units ( functional spinal unit , FSU ) , @ units in C@ ,@ , C@ ,@ , C@ ,@ and C@ ,@ each .


The subjects were randomly divided into group A and B.


The anterior transpedicular screw-plate system and anterior vertebral body screw-plate system were implanted separately in group A and B. Then , the maximum axial pull out strength was tested and compared between two fixation system .


Maximum pull out strength was ( @ + / - @ ) N in group A and ( @ + / - @ ) N in group B , and there was significant difference between two groups ( t = @ , P < @ ) .


There was no statistically significant difference in all FSU between anterior transpedicular screws system and vertebral body screws system ( F ( A ) = @ , F ( B ) = @ , P > @ ) .


The pull out strength of anterior transpedicular screws system is better than vertebral body screws system , and the anterior transpedicular screws has the biomechanical feasibility in clinic .


Activation of the melanocortin-@ receptor ( MC@R ) with the synthetic agonist RM-@ decreases body weight and increases energy expenditure ( EE ) in nonhuman primates .


The effects of MC@R agonists on EE in humans have not been examined to date .


In a randomized , double-blind , placebo-controlled , crossover study , we examined the effects of the MC@R agonist RM-@ on resting energy expenditure ( REE ) in obese subjects in an inpatient setting .


Twelve healthy adults ( @ men and @ women ) with body mass index of @ @ kg/m ( @ ) ( mean SD ) received RM-@ ( @ mg/@ h ) or placebo by continuous subcutaneous infusion over @ hours , followed immediately by crossover to the alternate treatment .


All subjects received a weight-maintenance diet ( @ % carbohydrate , @ % fat , and @ % protein ) and performed @ minutes of standardized exercise daily .


Continuous EE was measured on the third treatment day in a room calorimeter , and REE in the fasting state was defined as the mean of @ @-minute resting periods .


RM-@ increased REE vs placebo by @ % ( @ % confidence interval , @-@ @ % ) , on average by @ kcal/@ h ( @ % confidence interval , @-@ kcal , P = @ ) .


Total daily EE trended higher , whereas the thermic effect of a test meal and exercise EE did not differ significantly .


The @-hour nonexercise respiratory quotient was lower during RM-@ treatment ( @ @ vs @ @ , P = @ ) .


No adverse effect on heart rate or blood pressure was observed .


Short-term administration of the MC@R agonist RM-@ increases REE and shifts substrate oxidation to fat in obese individuals .


Conventional total knee arthroplasty is performed with use of an intramedullary alignment guide , which produces elevated intramedullary pressure that can create fat emboli .


Total knee arthroplasty performed via computer-assisted surgery does not require an intramedullary femoral rod , raising the question of whether computer-assisted surgery generates less embolic material than conventional total knee arthroplasty .


The purpose of this study was to compare the emboli produced in the two techniques .


Fifty-seven patients were randomized into two groups : the computer-assisted surgery group ( n = @ ) and the conventional total knee arthroplasty group ( n = @ ) .


An intramedullary femoral alignment jig was used in the conventional total knee arthroplasty group but not in the computer-assisted surgery group .


Intraoperative invasive monitoring was performed with use of transesophageal echocardiography and a pulmonary artery catheter .


The mean embolic score was @ points for the conventional technique group and @ points for the computer-assisted surgery group ( p = @ ) .


After tourniquet deflation , fat emboli were observed in the blood of five patients in the conventional surgery group and one patient in the computer-assisted surgery group .


The patients in the computer-assisted surgery group had lower embolic loads compared with the patients in the conventional total knee arthroplasty group .


In patients with an uncompromised cardiopulmonary system , the embolic load difference between the techniques was not clinically relevant .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Cardiovascular disease , endothelial dysfunction , and oxidative stress are common complications among patients with type @ diabetes ( T@DM ) .


In addition to the average blood glucose concentration , glycemic variability may be an important factor for the development of chronic diabetes complications .


Patients with T@DM are treated with various types of oral glucose-lowering drugs .


Exercise is considered to benefit the health of both healthy and unhealthy individuals , which has been confirmed by a number of scientific research studies in which the participants ' health improved .


Our general aim in this study will be to evaluate glucose variability after submaximal exercise test in patients receiving treatment with either vildagliptin or glibenclamide .


The specific aims of this study are to evaluate the oxidative stress , endothelial function , and metabolic and cardiovascular responses to exercise under treatment with vildagliptin or glibenclamide .


All these responses are important in patients with T@DM .


This study is a PROBE ( Prospective , Randomized , Open-label , Blinded-Endpoint ) design clinical trial .


The estimated sample needed is @ patients with T@DM .


In addition to the routine treatment ( metformin ) , patients will receive a second drug orally for @ weeks : the METV group will receive metformin plus vildagliptin ( @ mg twice daily ) , and the METG group will receive metformin plus glibenclamide ( @ to @ mg twice daily . )


Before and after intervention , evaluation of glycemic variability , endothelial function , oxidative stress , and metabolic and cardiovascular response will be performed at rest , during and after a submaximal exercise test ( @ minutes , with an intensity based at @ % under the heart rate at the second threshold ) .


In addition to drug treatment , exercise is recommended for treatment of glycemic control in patients with T@DM , especially for its beneficial effects on blood glucose and HbA@c .


Few studies have determined the effects of the association between exercise and oral glucose-lowering drugs .


The study will be conducted to assess the metabolic and cardiovascular responses at rest , and during and after submaximal exercise in patients receiving one of two oral glucose-lowering drugs ( vildagliptin or glibenclamide ) .


Injury knowledge and beliefs influence uptake of prevention programmes , but the relationship between knowledge , beliefs and adherence remains unclear .


To describe injury knowledge and beliefs among youth female soccer coaches and players , and to identify the relationship between these factors , different delivery strategies of the FIFA @ + programme and adherence .


A subcohort analysis from a cluster-randomised controlled trial of @ female soccer teams ( coaches n = @ , players ( ages @-@ ) n = @ ) .


Preseason and postseason questionnaires were used to assess knowledge and beliefs .


Teams recorded FIFA @ + adherence during the season .


At baseline , @ % ( @ % CI @ % to @ % ) of coaches and @ % ( @ % CI @ % to @ % ) of players considered ` inadequate warm-up ' a risk factor for injury .


There was no effect of delivery method ( OR = @ ; @ % CI @ to @ ) or adherence ( OR = @ ; @ % CI @ to @ ) on this belief .


At baseline , @ % ( @ % CI @ % to @ % ) of coaches believed a warm-up could prevent muscle injuries , but none believed it could prevent knee and ankle injuries .


For players , @ % ( @ % CI @ % to @ % ) , @ % ( @ % CI @ % to @ % ) and @ % ( @ % CI @ % to @ % ) believed a warm-up would prevent muscle , knee and ankle injuries , respectively .


Years of playing experience were negatively associated with high adherence for coaches ( OR = @ ; @ to @ ) and players ( OR = @ ; @ to @ ) .


There were gaps in injury knowledge and beliefs , which differed for coaches and players .


Beliefs did not significantly affect adherence to the FIFA @ + , suggesting additional motivational factors should be considered .


Social network analysis was used to examine whether peer influence from one 's social networks moderates obesity prevention program effects on obesity-related behaviors : healthful and unhealthful .


Participants included @ children residing in Southern California .


The survey assessed health-promoting behaviors ( i.e. , physical activity at school , physical activity outside of school , and fruit and vegetable intake ) , as well as unhealthful behaviors ( high-calorie , low-nutrient intake and sedentary activity ) , and peer exposure calculated from social network nominations as indicators of peer influence .


Multilevel models were conducted separately on outcomes predicted by program participation , peer exposure , and program participation by peer exposure .


Results indicated that peer exposure was positively associated with one 's own healthful and unhealthful behaviors .


Program participation effects were moderated by peer influence , but only when unhealthful peer influence was present .


Results suggest that peer influence can diminish or amplify prevention programs


Future interventions should consider peer-led components to promote healthful influence of peers on healthful and unhealthful behaviors , and programs should be mindful that their effects are moderated by social networks .


Chronic obstructive pulmonary disease ( COPD ) remains a major health problem , strongly related to smoking .


Despite the publication of practice guidelines on prevention and treatment , not all patients with the disease receive the recommended healthcare , particularly with regard to smoking cessation advice where applicable .


We have developed a tailored implementation strategy for enhancing general practitioners ' adherence to the disease management guidelines .


The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners ' adherence to guidelines .


A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care .


The study will involve @ general practices ( @ in the intervention group and @ in the control group ) in Poland , each with at least @ identified ( at the baseline ) patients with diagnosed COPD .


The nine control practices will provide usual care without any interventions .


Tailored interventions to implement four recommendations will be delivered in the remaining nine practices .


At follow-up after nine months , data will be collected for all @ general practices .


The primary outcome measure is physicians ' adherence to all four recommendations : brief anti-smoking advice , dyspnea assessment , care checklist utilization and demonstration to patients of correct inhaler use .


This measurement will be based on data extracted from identified patients ' records .


Additionally , we will survey and interview patients with chronic obstructive pulmonary disease about the process of care .


The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care .


Despite widespread use internationally , there is no convincing evidence that community treatment orders ( CTO ) ( legal regimes making out-patient treatment compulsory ) , reduce readmission rates or have wider patient benefit .


The primary and secondary outcomes of the Oxford Community Treatment Order Evaluation Trial ( OCTET ) ( hospitalisation ) showed no benefit .


This article will , first , test the effect of community compulsion on wider clinical and social outcomes and on patients ' experiences of services and the use of treatment pressure and second , explore differential effects in different groups of patients .


OCTET is a RCT of CTO effectiveness .


Three hundred and thirty-six patients were randomised and data for the @ eligible patients were collected from interviews and medical records at baseline , @ and @months .


There was no significant difference at @ months between the two arms in any of the reported outcomes , except a small difference in patients ' view of the effectiveness of treatment pressure , which is unlikely to be clinically meaningful .


Two statistically significant interactions were found in the subgroup analysis : symptoms interacted with age and with education , but no pattern was demonstrated .


CTOs do not have benefit on any of the tested outcomes , or for any subgroup of patients .


Their continued use should be carefully reconsidered .


Tobacco use is common among emergency department ( ED ) patients , many of whom have low income .


Our objective is to study the efficacy of an intervention incorporating motivational interviewing , nicotine replacement , and quitline referral for adult smokers in an ED .


This was a @-arm randomized clinical trial conducted from October @ to December @ in a northeastern urban US ED with @,@ visits per year .


Eligible subjects were aged @ years or older , smoked , and were self-pay or had Medicaid insurance .


Intervention subjects received a motivational interview by a trained research assistant , @ weeks ' worth of nicotine patches and gum initiated in the ED , a faxed referral to the state smokers ' quitline , a booster call , and a brochure .


Control subjects received the brochure , which provided quitline information .


The primary outcome was biochemically confirmed tobacco abstinence at @ months .


Secondary endpoints included quitline use .


Of @ enrolled subjects , @ ( @ % ) were alive at @ months .


The prevalence of biochemically confirmed abstinence was @ % ( @/@ ) in the intervention arm versus @ % ( @/@ ) in the control arm , for a difference in quit rates of @ % ( @ % confidence interval @ % to @ % ) .


In multivariable logistic modeling controlling for age , sex , and race or ethnicity , study subjects remained more likely to be abstinent than controls ( odds ratio @ ; @ % confidence interval @ to @ ) .


An intensive intervention improved tobacco abstinence rates in low-income ED smokers .


Because approximately @ million smokers , many of whom have low income , visit US EDs annually , these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers .


We evaluated the cross-time association between midlife dietary vitamin D intake and subsequent cognitive performance in a French general-population sample .


Data from participants in both the SU.VI.MAX trial ( @-@ ) and the SU.VI.MAX @ observational study ( @-@ ) were used .


Dietary intake was estimated at baseline from @ or more @-hour records .


Cognitive performance was evaluated @ years later with a comprehensive neuropsychological battery .


Parameter estimates of cognitive performance according to quartiles ( Q ) of vitamin D intake were estimated via ANCOVA .


In a sample of @,@ aging adults , principal component analyses yielded two cognitive factors - for episodic/semantic memory and short-term memory/executive function ; however , neither one displayed associations with dietary vitamin D intake .


Midlife vitamin D intake was significantly and positively associated with scores on the forward digit span task measuring short-term memory ( fully adjusted model : mean difference , Q@ vs. Q@ = @ ; @ % CI @-@ @ ; p ( trend ) = @ ) .


No significant interaction with either sex or lifetime sun exposure was found .


Midlife vitamin D intake exhibited a cross-time and domain-specific association with cognition in the context of aging .


Further investigations in this area of prevention are warranted given the rapidly expanding elderly population and the absence of curative treatment for dementia .


Death from infection is a highly heritable trait , yet there are few genetic variants with known mechanism influencing survival during septic shock .


We hypothesized that a synonymous coding variant in the IL-@ receptor antagonist gene ( IL@RN ) , rs@ , previously associated with reduced risk for acute respiratory distress syndrome , would be functional and associate with improved survival in septic shock .


We used a human endotoxin ( LPS ) model of evoked inflammatory stress to measure plasma IL-@ receptor antagonist ( IL@RA ) following low-dose Food and Drug Administration-grade LPS injection ( @ ng/kg ) in @ human volunteers .


RNA sequencing of adipose tissue pre - and post-LPS was used to test for allelic imbalance at rs@ .


In the Vasopressin and Septic Shock Trial cohort , we performed a genetic association study for survival , mortality , and organ failure-free days .


Adipose tissue displayed significant allelic imbalance favoring the rs@C allele in subjects of European ancestry .


Consistent with this , carriers of rs@C had slightly higher plasma IL@RA at baseline ( @ ) and higher evoked IL@RA post-LPS ( @ ) .


In the Vasopressin and Septic Shock Trial cohort , rs@C associated with improved survival ( P = @ ) , decreased adjusted @-day mortality ( P = @ ) , and faster resolution of shock ( P = @ ) .


In European ancestry subjects , the IL@RN variant rs@C is preferentially transcribed and associated with increased evoked plasma IL@RA and with improved survival from septic shock .


It may be that genetically determined IL@RA levels influence survival from septic shock .


The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis .


This was a @-week , randomized and controlled , parallel group , examiner-blind , single-center clinical study of @ adults with pre-existing gingivitis and plaque .


At baseline , the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and total number of bleeding sites were assessed , along with plaque levels ( whole mouth , gingival margin , and interproximal ) via the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Qualified subjects were randomly assigned to one of two power toothbrush test groups : the Oral-B Triumph with SmartGuide ( marketed in the United States as the Oral-B Professional Care SmartSeries @ -LSB- D@ -RSB- ) oscillating-rotating brush , or the Colgate ProClinical A@ ( also marketed as elmex ProClinical ) sonic brush .


Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice , and were reevaluated for gingivitis at Week @ and Week @ via the MGI , GBI , and total number of bleeding sites , and for plaque reduction via the RMNPI .


Ninety-seven percent ( @ % ) of the @ enrolled subjects completed the trial and @ and @ subjects in the oscillating-rotating and sonic brush groups , respectively , had evaluable data for analysis .


Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks @ and @ with unsupervised use of both test toothbrushes ( p < @ ) .


The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI ( @ % and @ % at Weeks @ and @ , respectively ; p < @ ) , GBI ( @ % at Week @ ; p = @ ) , and total number of bleeding sites ( @ % and @ % at Weeks @ and @ , respectively ; p = @ ) , and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque ( @ % and @ % at Weeks @ and @ , respectively ; p < @ ) , gingival margin plaque ( @ % at Week @ ; p = @ ) , and interproximal plaque ( @ % and @ % at Weeks @ and @ , respectively ; p < @ ) .


Both power toothbrushes were well-tolerated .


An advanced oscillating-rotating power toothbrush produced substantial , statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and @ weeks of tooth brushing .


The objective of our study was to determine the feasibility of using Metal Artifact Reduction ( MAR ) software for abdominopelvic dual-energy CT in patients with metal hip prostheses .


This retrospective study included @ patients ( male-female ratio , @:@ ; mean age , @ years ) who received total hip replacements and @ patients who did not have metal prostheses as the control group .


All of the patients underwent dual-energy CT. .


The quality of the images reconstructed using the MAR algorithm and of those reconstructed using the standard reconstruction was evaluated in terms of the visibility of the bladder wall , pelvic sidewall , rectal shelf , and bone-prosthesis interface and the overall diagnostic image quality with a @-point scale .


The mean and SD attenuation values in Hounsfield units were measured in the bladder , pelvic sidewall , and rectal shelf .


For validation of the MAR interpolation algorithm , pelvis phantoms with small bladder `` lesions '' and metal hip prostheses were made , and images of the phantoms both with and without MAR reconstruction were evaluated .


Image quality was significantly better with MAR reconstruction than without at all sites except the rectal shelf , where the image quality either had not changed or had worsened after MAR reconstruction .


The mean attenuation value was changed after MAR reconstruction to its original expected value at the pelvic sidewall ( p < @ ) and inside the bladder ( p < @ ) .


The SD attenuation value was significantly decreased after MAR reconstruction at the pelvic sidewall ( p = @ ) but did not show significant differences at the bladder ( p = @ ) or rectal shelf ( p = @ ) .


In the phantom study , all lesions obscured by metal artifacts on the standard reconstruction images were visualized after MAR reconstruction ; however , new artifacts had developed in other parts of the MAR reconstruction images .


The use of MAR software with dual-energy CT decreases metal artifacts and increases diagnostic confidence in the assessment of the pelvic cavity but also introduces new artifacts that can obscure pelvic structures .


To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate ( MTX ) in an open-label extension study in patients with active rheumatoid arthritis ( RA ) .


Following a @-week , randomized , double-blind trial of adding iguratimod or placebo to stable MTX therapy , patients entered a @-week extension .


Patients randomized to the iguratimod + MTX group continued treatment .


Patients treated with placebo + MTX switched to iguratimod + MTX -LSB- the ( placebo/iguratimod ) + MTX group -RSB- .


In the iguratimod + MTX group , the rate of @ % improvement in American College of Rheumatology criteria ( ACR@ ) at week @ ( @ % ) was similar to that at week @ ( @ % ) .


ACR@ , ACR@ and Health Assessment Questionnaire Disability Index at week @ significantly improved compared with the values at week @ .


In the ( placebo/iguratimod + MTX ) group , the switch to iguratimod treatment significantly improved ACR@ from @ % at week @ to @ % at week @ .


Frequent adverse events for @ weeks in the iguratimod + MTX group were nasopharyngitis , upper respiratory tract inflammation , stomatitis , lymphocyte decrease , AST increase , ALT increase and blood iron decrease .


These adverse events were predominantly mild or moderate in severity .


No deaths occurred .


Efficacy and tolerance of iguratimod + MTX therapy was maintained to @ weeks in patients with active RA with inadequate response to MTX .


Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses .


Most interventions are in-person small-group formats , which limit their reach and reduce their overall public health impact .


This study evaluated the efficacy of RealConsent , a Web-based bystander approach to sexual violence prevention , in enhancing prosocial intervening behaviors and preventing sexual violence perpetration .


A random probability sample of @ male undergraduate students ( aged @ to @ years ) attending a large , urban university located in the southeastern United States was recruited online and randomized to either RealConsent ( n = @ ) or a Web-based general health promotion program ( n = @ ) .


Participants were surveyed online at baseline , postintervention , and @-months postintervention .


RealConsent was delivered via a password-protected Web portal that contained six @-minute media-based and interactive modules covering knowledge of informed consent , communication skills regarding sex , the role of alcohol and male socialization in sexual violence , empathy for rape victims , and bystander education .


Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration .


Secondary outcomes were theoretical mediators ( eg , knowledge , attitudes ) .


At @-month follow-up RealConsent participants intervened more often ( P = @ ) and engaged in less sexual violence perpetration ( P = @ ) compared to controls .


In addition , RealConsent participants reported greater legal knowledge of sexual assault ( P < @ ) , greater knowledge of effective consent ( P < @ ) , less rape myths ( P < @ ) , greater empathy for rape victims ( P < @ ) , less negative date rape attitudes ( P < @ ) , less hostility toward women ( P = @ ) , greater intentions to intervene ( P = @ ) , less hyper-gender ideology ( P < @ ) , less positive outcome expectancies for nonconsensual sex ( P = @ ) , more positive outcome expectancies for intervening ( P < @ ) , and less comfort with other men 's inappropriate behaviors ( P < @ ) .


Our results support the efficacy of RealConsent .


Due to its Web-based format , RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence .


HIV spread rapidly among people who inject drugs in Bangkok in the late @s .


In recent years , changes in drug use and HIV-associated risk behaviors have been reported .


We examined data from the Bangkok Tenofovir Study , an HIV pre-exposure prophylaxis trial conducted among people who inject drugs , to assess participant risk behavior and drug use , and to identify risk factors for HIV infection .


The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial .


HIV status was assessed monthly and risk behavior every @ months .


We used generalized estimating equations logistic regression to model trends of injecting , needle sharing , drugs injected , incarceration , and sexual activity reported at follow-up visits ; and proportional hazards models to evaluate demographic characteristics , sexual activities , incarceration , drug injection practices , and drugs injected during follow-up as predictors of HIV infection .


The proportion of participants injecting drugs , sharing needles , and reporting sex with more than one partner declined during follow-up ( p < @ ) .


Among participants who reported injecting at enrollment , @ ( @ % ) injected methamphetamine , @ ( @ % ) midazolam , and @ ( @ % ) heroin .


In multivariable analysis , young age ( i.e. , @-@ years ) ( p = @ ) , sharing needles ( p < @ ) , and incarceration in prison ( p = @ ) were associated with incident HIV infection .


Participants reporting sex with an opposite sex partner , live-in partner , casual partner , or men reporting sex with male partners were not at a significantly higher risk of HIV infection compared to those who did not report these behaviors .


Reports of HIV-associated risk behavior declined significantly during the trial .


Young age , needle sharing , and incarceration were independently associated with HIV infection .


Sexual activity was not associated with HIV infection , suggesting that the reduction in HIV incidence among participants taking daily oral tenofovir compared to those taking placebo was due to a decrease in parenteral HIV transmission .


In our published randomized , double-blind , placebo-controlled , @-period crossover trial , healthy adult men ( n = @ ) consumed bars containing no supplemental fiber ( placebo ; NFC ) , polydextrose ( @ g/d ) , and soluble corn fiber ( SCF ; @ g/d ) for @ d each .


Fecal specimens were collected between days @ and @ for fermentative end-product analysis and @S ribosomal RNA bacterial gene amplification for bacterial taxa identification .


Fiber supplementation decreased fecal putrefaction compounds and shifted abundances of several bacterial taxa .


The objective was to perform whole-genome shotgun @ pyrosequencing on the same fecal specimens collected in that clinical trial to obtain comprehensive fecal bacterial genome sequencing coverage and explore the full range of bacterial genetic information in the fecal microbiome , thereby using a systematic approach to study the impact of dietary fiber supplementation on fecal metabolites , bacterial taxa , and bacterial metagenomes .


Fecal samples were subjected to whole-genome shotgun @ pyrosequencing to identify both fecal bacterial populations present and their functional genetic capacity .


Whole-genome shotgun sequencing results revealed that fiber consumption shifted the Bacteroidetes : Firmicutes ratio , increasing the relative abundance of Bacteroidetes @ @ % and @ @ % with polydextrose and SCF , respectively , compared with NFC .


Bivariate correlations showed a positive correlation between the Bacteroidetes : Firmicutes ratio and total dietary fiber intake but not body mass index .


Principal coordinates analysis of Bray-Curtis distances indicated that bacterial gene composition was more similar in participants consuming fibers ( polydextrose and SCF combined ) in comparison with NFC .


Shifts in bacterial gene abundances after polydextrose and SCF supplementation included genes associated with carbohydrate , amino acid , and lipid metabolism , as well as metabolism of cofactors and vitamins .


This study conveys novel information about the impact of dietary fiber supplementation on the phylogenetic structure and functional capacity of the fecal microbiome of healthy adults .


Intermediate care is intended to reduce hospital admissions and facilitate early discharge .


In Norway , a model was developed with transfer to intermediate care shortly after hospital admission .


Efficacy and safety of this model have not been studied previously.In a parallel-group randomized controlled trial , patients over @ years living at home before admission were eligible if clinically stable , without need for surgical treatment and deemed suited for intermediate care by attending physician .


Intervention group patients were transferred to a nursing home unit with increased staff and multidisciplinary assessment , for a maximum stay of three weeks .


Patients in the control group received usual care in hospital .


Blinding to group assignment was not possible.The primary outcome was number of days living at home in a follow-up period of @ days .


Secondary outcomes were mortality , hospital admissions , need for residential care and home care services .


Data were obtained from patient records and registers .


@ patients were included , @ % female and mean age @ years .


There was no significant differences between intervention ( n = @ ) and control group ( n = @ ) for number of days living at home ( @ vs @ , p = @ ) or days in hospital ( @ vs @ , p = @ ) .


Intervention group patients spent less time in nursing home ( @ days vs. @ , p = @ ) , and more patients lived independently without home health care services ( @ % vs @ % , p = @ ) .


For orthopaedic patients ( n = @ ) , mortality was higher in the intervention group ; @ intervention patients and @ controls died ( @ % vs @ % , p = @ ) .


There was no significant difference in one-year mortality for medical patients ( n = @ ) or the total study population .


This model of rapid transfer to intermediate care did not significantly influence number of days living at home during one year follow-up , but reduced demand for nursing home care and need for home health care services .


In post-hoc analysis mortality was increased for orthopedic patients .


Individuals with eating disorders show deficits in neuropsychological functioning which might preexist and underlie the etiology of the eating disorders and influence relapse .


Deficits in cognitive flexibility , i.e. , set-shifting and central coherence , might perpetuate the symptoms .


Cognitive remediation therapy ( CRT ) was developed to improve cognitive flexibility , thereby increasing the likelihood of improved outcome .


The focus of CRT is on how patients think , rather than on what patients think .


The present study investigated the effectiveness of CRT for patients with a severe or enduring eating disorder by means of a randomized controlled trial comparing intensive treatment as usual ( TAU ) to CRT plus TAU .


Eighty-two patients were randomly assigned to CRT plus TAU ( n = @ ) or TAU alone ( n = @ ) .


Outcome measures were set-shifting , central coherence , eating disorder and general psychopathology , motivation , quality of life and self-esteem .


Assessments were performed at baseline ( n = @ ) and after @ weeks ( T@ ; n = @ ) and @ months ( T@ ; n = @ ) .


Data were analyzed by means of linear mixed model analyses .


Patients who received CRT in addition to TAU improved significantly more with regard to eating disorder-related quality of life at the end of treatment ( T@ ) and eating disorder psychopathology at follow-up ( T@ ) , compared to those who received TAU only .


Moreover , moderator analyses revealed that patients with poor baseline set-shifting abilities benefited more from CRT than patients with no deficits in set-shifting abilities at baseline ; the quality of life of the former group was higher than that of the latter at follow-up .


CRT seems to be promising in enhancing the effectiveness of concurrent treatment .


Depression is one of the most common psychiatric illnesses worldwide , but is nevertheless preventable .


Since the children of parents who have depression are at greatest risk of developing depression themselves , prevention programmes for this population are a major public health priority .


Here we report the study protocol of a randomised controlled trial of a group-based psychological intervention for families with i ) at least one parent who suffers ( or has suffered ) from depression and ii ) at least one child who has no current or previous psychiatric diagnosis .


Eligible families will be randomly allocated to receive either a German adaptation of the @-session cognitive-behavioural Raising Healthy Children intervention ( Gesund und glcklich aufwachsen ; N = @ ) , or no intervention ( usual care ; N = @ ) .


The primary outcome ( child diagnosis of an episode of depression ) will be assessed at @-month follow-up .


The secondary outcomes ( child psychopathological symptoms ) will be assessed immediately following completion of the intervention ( @-months ) , as well as at @ - and @-month follow-up .


We hypothesise that children in the intervention condition , compared with those who do not receive the intervention , will show fewer symptoms of psychopathology , and be less likely to meet diagnostic criteria for a depressive episode , at follow-up .


Despite their elevated risk of developing depression , there is little formal support available for the children of parents with depression .


This study provides an important step in the development of more effective depression prevention measures , which are needed if the personal , social and economic burden of depression is to be reduced .


The choice of anaesthetic technique for patients undergoing joint arthroplasty is debatable .


The hypothesis of this study was that general anaesthesia would generate a more favourable recovery profile than spinal anaesthesia .


We randomly allocated @ patients to either intrathecal bupivacaine or general anaesthesia with target-controlled infusion of remifentanil and propofol .


Length of hospital stay assessed as meeting discharge criteria was the primary outcome parameter .


Other outcome parameters were actual time of discharge , pain , use of rescue pain medication , blood loss , length of stay in the post-operative care unit , dizziness , post-operative nausea , need of urinary catheterisation and patient satisfaction .


General anaesthesia resulted in slightly reduced length of hospital stay ( @ vs. @h , P = @ ) , less nausea ( P = @ ) and dizziness ( P < @ ) .


General anaesthesia patients had higher pain scores during the first two post-operative hours ( P < @ ) but lower after @h compared with the spinal anaesthesia group ( P < @ and P < @ ) .


General anaesthesia patients had better orthostatic function compared with spinal anaesthesia patients ( P = @ ) .


Patients in the spinal anaesthesia group fulfilled the discharge criteria from the post-operative care unit earlier compared with the general anaesthesia patients ( P = @ ) .


General anaesthesia patients requested a change in the method of anaesthesia for a subsequent operation less often than the spinal anaesthesia patients ( @ vs. @ , P = @ ) .


General anaesthesia resulted in a more favourable recovery profile compared with spinal anaesthesia .


Why do limb tourniquets cause pain ?


If ischemia is the mechanism , can supplemental oxygen reduce pain ?


The Reducing Tourniquet Associated Pain study investigated whether this simple treatment could extend tourniquet tolerance time to facilitate hand surgery under local or regional anesthesia .


The Reducing Tourniquet Associated Pain study was a double-blind , randomized , controlled trial of healthy volunteers .


Participants received either @ % inhaled oxygen or air placebo via a face mask for @ minutes before and up to @ minutes after upper arm tourniquet inflation to @ mmHg .


Pain scores were recorded at @-minute intervals using a validated @-mm visual analogue scale .


The primary outcomes were ( @ ) difference in visual analogue scale score and ( @ ) difference in time taken to reach visual analogue score of @ mm or more in oxygen and air groups .


Fifty participants enrolled and , after exclusion criteria were applied , @ were analyzed ( oxygen , n = @ ; air , n = @ ) .


Oxygen supplementation was associated with a @ percent mean reduction in pain on visual analogue scoring compared with air placebo over the entire period of inhalation ( p = @ ) .


Oxygen also extended the time to visual analogue scale score of @ mm or more by a mean of @ minutes compared with air placebo ( p = @ ) .


Oxygen is a readily available , low-risk , low-cost treatment that significantly reduced tourniquet-associated pain in this study and significantly increased the time taken to reach visual analogue scale score of @ or more .


The authors recommend oxygen to facilitate hand surgery under a tourniquet and when a regional block fails to control tourniquet pain .


Pruritus is the hallmark clinical sign of atopic dermatitis ( AD ) in dogs .


Preliminary study results suggest that oclacitinib , a selective Janus kinase inhibitor , could reduce pruritus and associated inflammatory skin lesions in dogs with AD .


The objective was to evaluate efficacy and safety of oclacitinib ( Apoquel ) for the control of AD in a randomized , double-blind , placebo-controlled trial .


Clinicians at @ specialty clinics enrolled client-owned dogs ( n = @ ) with a history of chronic AD .


Dogs were randomized to receive either oclacitinib ( @-@ @ mg/kg twice daily for @ days and then once daily for up to @ days ) or an excipient-matched placebo .


Owners assessed visual analog scale ( VAS ) scores of pruritus on days @ , @ , @ , @ , @ , @ , @ , @ and @ .


Clinicians assessed Canine AD Extent and Severity Index ( CADESI-@ ) scores on days @ , @ , @ , @ , @ and @ .


On days @ , @ , @ , @ and @ , oclacitinib-treated dogs had a @ , @ , @ , @ and @ % reduction from baseline in owner-assessed pruritus scores , respectively , compared with a @ , @ , @ , @ and @ % reduction in placebo-treated dogs .


On days @ and @ , dermatologists recorded a @ % reduction in CADESI-@ scores in oclacitinib-treated dogs compared with a @ % reduction and a @ % increase in placebo-treated dogs .


After day @ , > @ % of all placebo-treated dogs had moved to an open-label study , making between-group comparisons biased .


Differences were significant at all time points assessed ( P < @ ) .


Oclacitinib provided rapid , effective and safe control of AD , with substantial improvement in VAS and CADESI-@ scores .


Systemic administration of dexmedetomidine has been shown to reduce opioid consumption and improve analgesia satisfaction .


The purpose of this study was to investigate the effect of intrathecal dexmedetomidine on spinal morphine analgesia in patients with refractory cancer pain .


A double-blinded crossover study was designed and performed .


Patients were randomly allocated in one of the two phases .


Phase M received intrathecal morphine administration .


Phase M+D received intrathecal morphine plus dexmedetomidine administration .


All patients were monitored for @ days and crossed over to alternate phase for another @-week observation .


Daily average visual analog scale ( VAS ) pain score , pain frequency , sleep deprivation , daily morphine consumption , bolus dose injection times , and side effects were all recorded .


Pain intensity and frequency were significantly decreased in both phases compared with baseline .


Daily morphine consumption and bolus dose injection times during phase M+D were significantly decreased compared with phase M.


The incidences of constipation were significantly reduced in both phases compared with baseline administration , but nausea and vomiting were significantly increased .


No serious side effects such as respiratory inhibition were observed in this study .


Intrathecal administration of dexmedetomidine and morphine reduced the morphine consumption in patients with refractory cancer pain .


There were no serious side effects .


With little scientific evidence to support use of aromatherapy for postoperative nausea and/or vomiting ( PONV ) symptoms , this study evaluated controlled breathing with peppermint aromatherapy ( AR ) and controlled breathing alone ( CB ) for PONV relief .


A single blind randomized control trial design was used .


On initial PONV complaint , symptomatic subjects received either CB ( n = @ ) or AR ( n = @ ) intervention based on randomization at enrollment .


A second treatment was repeated at @ minutes if indicated .


Final assessment occurred @ minutes post initial treatment .


Rescue medication was offered for persistent symptoms .


Among eligible subjects , PONV incidence was @ % ( @/@ ) .


Gender was the only risk factor contributing to PONV symptoms ( P = @ ) .


Though not statistically significant , CB was more efficacious than AR , @ % versus @ % , respectively .


CB can be initiated without delay as an alternative to prescribed antiemetics .


Data also support use of peppermint AR in conjunction with CB for PONV relief .


This randomized crossover trial aimed to compare the effects of @ different protocols using pedometers and informative booklets to increase physical activity in daily life ( PADL ) in smokers .


PADL level was assessed at baseline ( A@ ) , and subjects were randomly assigned to @ groups for a month : booklet + pedometer ( GB + P ; n = @ ) , which started the protocol receiving a booklet with encouragement to walk as much as possible in everyday life ; pedometer + booklet ( GP + B ; n = @ ) , which started the protocol wearing a pedometer aiming to achieve @,@ steps/day .


PADL was reassessed ( A@ ) , and the interventions were crossed over for @ month , followed by PADL reassessment ( A@ ) .


After A@ , both groups used pedometers for @ months aiming to reach @,@ steps/day , and final PADL assessment was performed ( A@ ) .


For the analysis , each group was subdivided according to baseline PADL as physically active or inactive , according to having reached or not reached @,@ steps/day at baseline .


The physically active subgroups of GB + P and GP + B showed no change in steps/day .


The physically inactive subgroup of GP + B significantly increased steps/day at A@ and maintained this increase until A@ .


The physically inactive subgroup of GB + P initially increased to a lesser extent , reaching borderline statistical significance at A@ and A@ ( p = @ ) and statistically significant increase only at A@ ( p = @ ) .


Both strategies were effective in increasing the number of steps/day in physically inactive smokers after @ months , although the increase was more quickly obtained in smokers who used pedometers as the first intervention .


To clarify the effectiveness of second-look endoscopy ( SLE ) at preventing bleeding after gastric endoscopic submucosal dissection ( ESD ) .


A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan .


Patients with a solitary gastric neoplasm were enrolled .


Exclusion criteria were previous oesophagogastric surgery or radiation therapy ; perforation and the administration of antithrombotics , steroids or non-steroidal anti-inflammatory drugs .


Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor .


SLE was performed one day after ESD .


The primary endpoint was post-ESD bleeding , defined as an endoscopically proven haemorrhage .


The trial had the power to detect a non-inferiority criterion of @ % between the groups .


From February @ to February @ , @ and @ patients were assigned to the SLE and the non-SLE groups , respectively .


All patients were included in the intention-to-treat analysis of the primary endpoint .


Post-ESD bleeding occurred in seven patients with ( @ % ) SLE and five patients with ( @ % ) non-SLE ( risk difference -- @ % ( @ % CI -@ to @ ) ; pnon-inferiority < @ ) , meeting the non-inferiority criterion .


All @ patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment .


SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk .


The response of diastolic Doppler indices to exercise is not well defined for young subjects .


The aims of this study were to evaluate this in nonathletic and endurance-trained probands and to correlate echocardiographic data with maximal oxygen consumption .


In this prospective study , Doppler echocardiography was performed at rest and after exercise in @ nonathletes ( NAs ) and @ endurance-trained athletes ( ETs ) aged < @ years , matched for age and gender .


Diastolic function was assessed by mitral inflow and early diastolic velocities of the septal ( e ' septal ) and lateral ( e ' lateral ) mitral annulus .


Maximal oxygen consumption quantification was performed simultaneously .


All cardiac chambers were larger in ETs than NAs .


ETs had higher e ' lateral at rest ( @ @ vs @ @ cm/sec , P = @ ) and higher mitral E ( @ @ vs @ @ cm/sec , P = @ ) and e ' lateral ( @ @ vs @ @ cm/sec , P = @ ) with exercise than NAs .


There was a slight increase in E/e ' septal ( overall , from @ @ to @ @ ; P = @ ) and E/e ' lateral ( overall , from @ @ to @ @ ; P < @ ) with exercise .


Changes in diastolic parameters with exercise were similar in ETs and NAs .


Percentage of predicted maximal oxygen consumption was correlated with exertional E ( r = @ , P = @ ) and e ' lateral ( r = @ , P = @ ) , but the strongest predictor was indexed left ventricular end-diastolic volume ( r = @ , P < @ ) .


During exercise , E/e ' increases but remains within normal ranges in healthy young subjects , and the response to exercise does not differ between ETs and NAs .


These data help define the normal diastolic stress echocardiographic response in the young .


Exercise capacity shows a correlation with enhanced exertional early diastolic velocities but is more closely related to cardiac structural adaption to endurance training .


Concept maps have been used to promote meaningful learning and critical thinking .


Although these are crucially important in all disciplines , evidence for the benefits of concept mapping for learning in medicine is limited .


We performed a randomised crossover study to assess the benefits of online testable concept maps for learning in pathology by volunteer junior medical students .


Participants ( n = @ ) were randomly allocated to either of two groups with equivalent mean prior academic performance , in which they were given access to either online maps or existing online resources for a @-week block on renal disease .


Groups then crossed over for a @-week block on hepatic disease .


Outcomes were assessed using timed online quizzes , which included questions unrelated to topics in the pathogenesis maps as an internal control .


Questionnaires were administered to evaluate students ' acceptance of the maps .


In both blocks , the group with access to pathogenesis maps achieved significantly higher average scores than the control group on quiz questions related to topics covered by the maps ( Block @ : p < @ , Cohen 's d = @ ; Block @ : p = @ , Cohen 's d = @ ) .


However , mean scores on unrelated questions did not differ significantly between the groups .


In a third block on pancreatic disease , both groups received pathogenesis maps and collectively performed significantly better on quiz topics related to the maps than on unrelated topics ( p < @ , Cohen 's d = @ ) .


Regression analysis revealed that access to pathogenesis maps was the dominant contributor to variance in performance on map-related quiz questions .


Responses to questionnaire items on pathogenesis maps were overwhelmingly positive in both groups .


These results indicate that online testable pathogenesis maps are well accepted and can improve learning of concepts in pathology by medical students .


Positional therapy ( PT ) is an effective therapy in positional obstructive sleep apnea syndrome ( POSAS ) when used , but the compliance of PT is low .


The objective of this study was to investigate whether a new kind of PT is effective and can improve compliance .


@ patients were treated with the Sleep Position Trainer ( SPT ) , @ patients with the Tennis Ball Technique ( TBT ) .


At baseline and @ month polysomnography , Epworth Sleepiness Scale ( ESS ) and the Quebec Sleep Questionnaire ( QSQ ) were taken .


Daily compliance was objectively measured in both groups .


Both therapies prevent supine sleep position to a median of @ % ( min-max : SPT @ % to @ % , TBT @ % to @ % ) , resulting in a treatment success ( AHI < @ ) in @ % of the SPT and @ % of the TBT patients .


The ESS at baseline was < @ in both groups .


Sleep quality parameters as wake after sleep onset ( WASO ; p = @ ) and awakenings ( p = @ ) improved more in the SPT group .


Total QSQ scores ( @ , p = @ ) and the QSQ domains nocturnal symptoms ( @ , p = @ ) and social interactions ( @ , p = @ ) changed in favor of the SPT group .


Effective compliance ( @ h/night + @ days/week ) was @ % for the SPT and @ % for the TBT users ( p = @ ) .


In mild POSAS with normal EES the new SPT device and the standard TBT are equally effective in reducing respiratory indices .


However , compared to the TBT , sleep quality , quality of life , and compliance improved significantly more in the SPT group .


Uric acid has been linked to the progression of native kidney disease .


Studies evaluating its contribution to allograft function in kidney transplant recipients , among whom hyperuricemia is common , have yielded mixed results .


We evaluated the association between baseline uric acid and the primary composite outcome of doubling of interstitium or ESRD from interstitial fibrosis and tubular atrophy ( IF/TA ) in the Angiotensin II Blockade for Chronic Allograft Nephropathy ( ABCAN ) Trial participants .


Subjects underwent uric acid , iothalamte GFR , and urine albumin to creatinine ( ACR ) measurements annually for @ years in addition to an allograft biopsy at baseline and @ years .


Baseline uric acid was @ mg/dL ; male sex , higher BMI , diuretic use , and lower GFR were associated with higher uric acid , whereas older age , less than @ HLA matches and having a female donor were associated with lower levels .


In multivariate analysis adjusting for baseline GFR , uric acid was associated with doubling of interstitium or ESRD from IF/TA ( OR @ , @ % CI , @-@ @ , P = @ ) .


Over time , a @ mg/dL increase in time-varying uric acid was associated with a @ mL/min lower final GFR ( P < @ ) but not with the secondary outcome of creatinine doubling , ESRD , or death .


These data suggest that uric acid is associated with IF/TA and thus may be a viable target for intervention .


Most orthodontists believe that fixed retainers are necessary to maintain ideal dental relationships .


However , untoward side effects might result from their long-term placement .


The aim of this study was to evaluate the clinical and radiographic effect of two commonly used fixed retainers on the health of the periodontium .


Thirty patients were randomly divided into two groups to receive either a fiber-reinforced composite retainer or a spiral wire retainer extended on the lingual surfaces of both maxillary and mandibular arches from canine to canine .


Periapical radiographs were obtained from the patients at the time of placement of the retainers and after the @-month period to assess the radiographic conditions of the periodontium .


Clinical examination was carried out at the same two time intervals .


Even though there were no significant differences between the two groups of study at the beginning of the trial , there were statistically significant differences after the @-month follow-up regarding the main outcomes of the study .


Nearly all indices showed to deteriorate after @ months in the fiber-reinforced group , while in the spiral wire group , this was not the case .


As for the secondary outcomes , radiographic examination did not reveal any statistically significant differences after @ months or between the two groups .


It can be concluded that spiral wire retainers elicit less detrimental periodontal response in the short-term follow-up compared to fiber-reinforced composite retainers as revealed by the primary outcomes of the study .


Muscle weakness and fatigue are common symptoms in multiple sclerosis ( MS ) .


Green tea catechins such as ( - ) epigallocatechin-@-gallate ( EGCG ) are known to improve energy metabolism at rest and during exercise .


We tested the hypothesis that EGCG improves energy metabolism and substrate utilization in patients with MS.


Eighteen patients ( @ men ) with relapsing-remitting MS ( expanded disability status scale score < @ , all receiving glatiramer acetate ) participated in this randomized , double-blind , placebo-controlled , crossover trial at a clinical research center .


All patients received EGCG ( @ mg/d ) and placebo over @ wk ( @-wk washout in between ) .


After each intervention , fasting and postprandial energy expenditure ( EE ) , as well as fat oxidation ( FAOx ) and carbohydrate oxidation ( CHOx ) rates , were measured either at rest or during @ min of exercise ( @ W/kg ) .


At rest , blood samples and microdialysates from adipose tissue and skeletal muscle were also taken .


At rest , postprandial EE and CHOx , as well as adipose tissue perfusion and glucose supply , were significantly lower in men but higher in women receiving EGCG compared with placebo .


During exercise , postprandial EE was lower after EGCG than after placebo , indicating an increased working efficiency ( men > women ) .


After placebo , exercise EE was mainly fueled by FAOx in both men and women .


After EGCG , there was a shift to a higher and more stable CHOx during exercise in men but not in women .


Our data indicate that EGCG given to patients with MS over @ wk improves muscle metabolism during moderate exercise to a greater extent in men than in women , possibly because of sex-specific effects on autonomic and endocrine control .


Observational evidence suggests that improving fetal growth may improve adult health .


Experimental evidence from nutritional supplementation trials undertaken amongst pregnant women in the less developed world does not show strong or consistent effects on adult disease risk and no trials from the more developed world have previously been reported .


To test the hypothesis that nutritional supplementation during pregnancy influences offspring disease risk in adulthood .


Clinical assessment of a range of established diseases risk markers in young adult offspring of @ South Asian mothers who participated in two trials of nutritional supplementation during pregnancy ( protein/energy/vitamins ; energy/vitamins or vitamins only ) at Sorrento Maternity Hospital in Birmingham UK either unselected or selected on the basis of nutritional status .


@ ( @ % ) offspring were traced and @ ( @ % ) of these were assessed in clinic .


Protein/energy/vitamins supplementation amongst undernourished mothers was associated with increased infant birthweight .


Nutritional supplementation showed no strong association with any one of a comprehensive range of markers of adult disease risk and no consistent pattern of association with risk across markers in offspring of either unselected or undernourished mothers .


We found no evidence that nutritional supplements given to pregnant women are an important influence on adult disease risk however our study lacked power to estimate small effects .


Our findings do not provide support for a policy of nutritional supplementation for pregnant women as an effective means to improve adult health in more developed societies .


Impaired cardiac isoform of sarco ( endo ) plasmic reticulum Ca ( @ + ) ATPase ( SERCA@a ) activity is a key abnormality in heart failure patients with reduced ejection fraction .


The CUPID @ ( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase @b ) trial is designed to evaluate whether increasing SERCA@a activity via gene therapy improves clinical outcome in these patients .


Intracoronary delivery of recombinant adeno-associated virus serotype @ ( AAV@ ) / SERCA@a improves intracellular Ca ( @ + ) handling by increasing SERCA@a protein levels and , as a consequence , restores systolic and diastolic function .


In a previous phase @a trial , this therapy improved symptoms , functional status , biomarkers , and left ventricular function , and reduced cardiovascular events in advanced heart failure patients .


CUPID @ is a phase @b , double-blind , placebo-controlled , multinational , multicenter , randomized event-driven study in up to @ patients with moderate-to-severe heart failure with reduced ejection fraction and New York Heart Association functional class II to IV symptoms despite optimal therapy .


Enrolled patients will be at high risk for recurrent heart-failure hospitalizations by virtue of having elevated N-terminal pro-B-type natriuretic peptide/BNP ( > @,@ pg/ml , or > @,@ pg/ml if atrial fibrillation is present ) and/or recent heart failure hospitalization .


The primary endpoint of time-to-recurrent event ( heart failure-related hospitalizations in the presence of terminal events -LSB- all-cause death , heart transplant , left ventricular assist device implantation or ambulatory worsening heart failure -RSB- ) will be assessed using the joint frailty model .


This ongoing trial is expected to complete recruitment in @ , with the required number of @ recurrent events estimated to occur by mid @ .


Available data indicate that calcium up-regulation by AAV@/SERCA@a gene therapy is safe and of potential benefit in advanced heart failure patients .


The CUPID @ trial is designed to study the effects of this therapy on clinical outcome in these patients .


( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase @b -LSB- CUPID-@b -RSB- ; NCT@ ) .


The EGF receptor ( EGFR ) and COX@ pathways are upregulated in head and neck squamous cell carcinoma ( HNSCC ) .


Preclinical models indicate synergistic antitumor activity from dual blockade .


We conducted a randomized , double-blind , placebo-controlled window trial of erlotinib , an EGFR inhibitor ; erlotinib plus sulindac , a nonselective COX inhibitor ; versus placebo .


Patients with untreated , operable stage II-IVb HNSCC were randomized @:@:@ to erlotinib , erlotinib-sulindac , or placebo .


Tumor specimens were collected before and after seven to @ days of treatment .


The primary endpoint was change in Ki@ proliferation index .


We hypothesized an ordering effect in Ki@ reduction : erlotinib-sulindac > erlotinib > placebo .


We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX@ signaling intermediates .


From @-@ , @ patients were randomized for the target @ evaluable patients .


Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation .


Ki@ was significantly decreased by erlotinib or erlotinib-sulindac ( omnibus comparison , two-sided Kruskal-Wallis , P = @ ) .


Wilcoxon pairwise contrasts confirmed greater Ki@ effect in both erlotinib groups ( erlotinib-sulindac vs. placebo , P = @ ; erlotinib vs. placebo , P = @ ) .


There was a significant trend in ordering of Ki@ reduction : erlotinib-sulindac > erlotinib > placebo ( two-sided exact Jonckheere-Terpstra , P = @ ) .


Low baseline pSrc correlated with greater Ki@ reduction ( R ( @ ) = @ , P = @ ) .


Brief treatment with erlotinib significantly decreased proliferation in HNSCC , with additive effect from sulindac .


Efficacy studies of dual EGFR-COX inhibition are justified .


pSrc is a potential resistance biomarker for anti-EGFR therapy , and warrants investigation as a molecular target .


This study was conducted to determine whether installation of sit-stand desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers .


A randomized cross-over trial was conducted from January to April , @ at a business in Minneapolis .


@ ( nine men , @ full-time ) sedentary office workers took part in a @ week intervention period which included the use of SSDs to gradually replace @ % of sitting time with standing during the workday .


Physical activity was the primary outcome .


Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes .


The intervention reduced sitting time at work by @ % ( @ % CI @ % -@ % ) and sedentary time by @ min/work-hr ( @ % CI @-@ @ min/work-hr ) .


For a @ h work-week , this translates into replacement of @ h of sitting time with standing and sedentary time being reduced by @ h. Activity level during non-work hours did not change .


The intervention also increased overall sense of well-being , energy , decreased fatigue , had no impact on productivity , and reduced appetite and dietary intake .


The workstations were popular with the participants .


The SSD intervention was successful in increasing work-time activity level , without changing activity level during non-work hours .


This study sought to determine whether red blood cell ( RBC ) transfusion increases in vivo platelet aggregation and inflammation in coronary and noncoronary patients .


RBC transfusion increases in vitro platelet activation and aggregation in healthy volunteers , providing a possible explanation for the increase in recurrent ischemic events and mortality reported after RBC transfusion in patients with acute coronary syndromes ( ACS ) .


Platelet reactivity was measured before and after RBC transfusion in @ patients ( @ with ACS patients and @ without ACS ) .


Relative changes between baseline and post-transfusion measurements of maximal and residual platelet aggregation were considered with different agonists as well as changes in vasodilator-stimulated phosphoprotein platelet reactivity index and P-selectin expression .


Inflammatory and thrombotic biomarkers were also measured before and after transfusion .


After RBC transfusion , platelet reactivity was increased when measured using adenosine diphosphate-induced light transmission aggregometry ( @ % relative increase in maximal platelet aggregation , p = @ ; @ % increase in residual platelet aggregation , p = @ ) and vasodilator-stimulated phosphoprotein platelet reactivity index ( @ % relative increase , p = @ ) , and there was a nonsignificant trend toward an increase in P-selectin expression .


Similar results were found with the nonspecific agonist thrombin receptor-activated peptide ( relative increases of @ % for maximal platelet aggregation , p = @ , and @ % for residual platelet aggregation , p = @ ) but not with collagen or arachidonic acid agonists .


There were no significant differences in inflammatory and thrombotic biomarkers before and after transfusion .


After RBC transfusion , there is an increase in platelet reactivity , especially with tests measuring the adenosine diphosphate-P@Y@ receptor pathway , without significant variations in inflammatory or thrombotic biomarkers .


This in vivo effect may account for the excess of ischemic events observed in the context of patients with ACS treated using percutaneous coronary intervention and P@Y@ inhibitors .


To evaluate the short-term digestive tolerance and glycaemic response of several associations of maltitol and short-chain fructo-oligosaccharides ( scFOS ) used to replace sugars ( for example , dextrose ) in foods .


Thirty-six healthy subjects aged @-@ years were recruited for the study and @ completed it .


The subjects consumed six different mixtures of dextrose , maltitol and scFOS added in a chocolate dairy dessert at a dosage of @g .


The test days were separated by @-week washout periods .


The subjects reported the intensity of four individual gastrointestinal ( GI ) symptoms , number of bowel movements and stool frequency for the @h following consumption of the dessert .


A subgroup of @ subjects also provided blood samples @h after intake to evaluate the postprandial glycaemic and insulinaemic responses .


The composite score calculated from the intensity of flatulence , borborygmi , bloating and discomfort was significantly higher ( P < @ ) for all the desserts containing maltitol and/or scFOS than for the control dessert containing dextrose , but remains at the level of mild effects .


The number of bowel movements was also slightly increased ( P = @ ) and the stools were softer ( P = @ ) for the first @h but not after ( P = @ and @ , respectively ) .


Blood glycaemic and insulinaemic responses were lower for all the sugar-free recipes containing maltitol and scFOS in comparison to the control one ( P < @ ) .


This study has shown that maltitol and scFOS can be used jointly when formulating sugar-free foods with the benefit to lower postprandial glycaemic response with only a small and transient increase in non-serious GI symptoms .


Endemic malaria and helminth infections in sub-Saharan Africa can act as immunological modulators and impact responses to standard immunizations .


We conducted a cohort study to measure the influence of malaria and helminth infections on the immunogenicity of the bivalent HPV-@ / @ vaccine .


We evaluated the association between malaria and helminth infections , and HPV-@ / @ antibody responses among @ Tanzanian females aged @-@ years enrolled in a randomized controlled trial of the HPV-@ / @ vaccine .


Malaria parasitaemia was diagnosed by examination of blood smears , and helminth infections were diagnosed by examination of urine and stool samples , respectively .


Geometric mean antibody titres ( GMT ) against HPV-@ / @ antibodies were measured by enzyme-linked immunosorbent assay .


Parasitic infections were common ; one-third ( @ % ) of participants had a helminth infection and @ % had malaria parasitaemia .


Overall , the vaccine induced high HPV-@ / @ GMTs , and there was no evidence of a reduction in HPV-@ or HPV-@ GMT at Month @ or Month @ follow-up visits among participants with helminths or malaria .


There was some evidence that participants with malaria had increased GMTs compared to those without malaria .


The data show high HPV immunogenicity regardless of the presence of malaria and helminth infections .


The mechanism and significance for the increase in GMT in those with malaria is unknown .


Polymorphic light eruption ( PLE ) is the most common photodermatosis .


Little is known about the efficacy of systemic photoprotection provided by nutritional supplements in PLE patients .


The purpose of this study was to assess efficacy of nutritional supplement containing lycopene , - carotene , and Lactobacillus johnsonii to diminish skin lesions induced by ` photoprovocation ' testing in PLE patients .


In this randomized , placebo-controlled , double-blinded study , @ PLE patients were supplemented with the nutritional supplement or placebo .


For inducing skin lesions , patient skin was exposed to single daily doses of @J/cm@ ultraviolet A@ ( UVA@ ) for two consecutive days .


Skin lesions were evaluated using a PLE score .