The response rate ( a composite response endpoint including lid width , soft tissue involvement , proptosis , intraocular pressure , Clinical Activity Score -LSB- CAS -RSB- , diplopia , and visual acuity ) was evaluated as the primary outcome , and adverse effects were recorded at each visit .


GO-associated serum cytokines were measured .


We found a significantly greater response rate for the weekly protocol vs the daily protocol at the @th week ( @ vs @ % ; P = @ ) and a similar response rate at the fourth week .


Seven patients on the daily protocol worsened when tapering iv methylprednisolone to oral prednisone in the fourth week .


Patients in both groups showed significant CAS response , and at the @th week , patients on the weekly protocol showed a nonsignificant trend toward greater CAS response .


Weekly protocol showed significant prolonged retreatment-free survival .


Severe side effects were only observed in two cases , both of which were on the daily protocol .


Furthermore , we observed sustained decreased levels of serum CXCL@ in the @th week compared to the baseline level ( P = @ ) in the patients on the weekly protocol .


The weekly protocol of iv methylprednisolone therapy is more efficient and safer than the daily protocol for patients with active moderate-to-severe GO .


Published data supporting the best practice for patients with atrial fibrillation ( AF ) presenting to the emergency department ( ED ) are limited .


Our objective was to evaluate the impact of an AF clinical protocol initiated in the ED with early follow-up in a specialty AF outpatient clinic .


This was a single-center prospective study of all consented patients with AF who were discharged from the ED through the AF clinical pathway and were then seen in the AF clinic .


The primary endpoint was the rate of @-day hospitalization/ED visits .


Secondary endpoints included adherence to established AF anticoagulation guidelines , rate of thromboembolic events , quality of life , and patient satisfaction .


One hundred consecutive patients were enrolled in the study .


Within @ days , @ had ED visits and @ were hospitalized , whereas none developed thromboembolic complications .


There were significant increases in the Atrial Fibrillation Effect on QualiTy of life survey quality of life ( @ @ vs. @ @ ; P < @ ) and patient satisfaction ( @ @ vs. @ @ ; P < @ ) scores from baseline to @ days .


Of the @ patients with CHADS@ score @ , @ ( @ % ) were discharged from the AF clinic with oral anticoagulation .


We describe a novel approach to the care of patients with AF presenting to the ED .


Usage of the ED-initiated AF clinical pathway with early follow-up in a protocol-driven AF clinic was associated with low readmission rates , no thromboembolic complications at @ days , improved quality of life , and high patient satisfaction .


The role of therapy on improvement of hypsarrhythmia has not been systematically assessed .


This study was performed to assess the efficacy of oral prednisolone and intramuscular adrenocorticotrophin hormone in improving hypsarrhythmia in West syndrome .


Children ( @ months-@ years ) , with previously untreated West syndrome , were randomized to receive @-@ IU every other day of intramuscular adrenocorticotrophin hormone or @-@ mg/day of oral prednisolone for @ days .


Children with tuberous sclerosis were excluded .


Improvement of hypsarrhythmia was assessed blindly using a hypsarrhythmia severity scale before and after completion of therapy .


Adverse effects were assessed on day @ using symptom diary .


( Clinical trial registry identifier : SLCTR/@/@ . )


From @ newly diagnosed West syndrome infants , @ were randomized to receive prednisolone and @ to receive adrenocorticotrophin hormone .


Eighty infants completed the posttreatment evaluation according to specifications .


The hypsarrhythmia severity score , significantly improved with hormonal therapy for @ weeks ( @ @ vs @ @ ) ; P < @ .


When individual treatment arms were compared using mean differences in the improvement of scores , improvement in prednisolone arm ( @ @ ) was significantly greater than that in the adrenocorticotrophin hormone arm ( @ @ ) ; P < @ .


Both forms of therapy were tolerated well .


Frequent crying , irritability , weight gain , increased appetite , and abdominal distension were more common ( but not statistically significant ) with prednisolone .


Hypsarrhythmia severity score improved significantly with both hormonal therapies , but this improvement was significantly better with oral prednisolone than intramuscular adrenocorticotrophin hormone .


This is the first ever documentation of a superior therapeutic role of oral steroids in West syndrome .


The aim of this study was to investigate the effect of a single dose of Brazil nuts on the inflammatory markers of healthy individuals .


A randomized crossover study was conducted with @ healthy individuals ( mean age @ @ y ) .


Each individual was tested four times regarding intake of different portions of Brazil nuts : @ , @ , @ and @ g.


At each testing period , peripheral blood was collected before and at @ , @ , @ , @ , @ , and @ h after intake of nuts , as well as at @ and @ d after intake of various Brazil nut portions .


Blood samples were tested for high-sensitivity to C-reactive protein , interleukin ( IL ) -@ , IL-@ , IL-@ , tumor necrosis factor ( TNF ) - , and interferon ( IFN ) - , aspartate and alanine aminotransferases , albumin , total protein , alkaline phosphatase , gamma-glutamyltransferase , urea , and creatinine .


Consumption of nuts did not affect biochemical parameters for liver and kidney function , indicating absence of hepatic and renal toxicity .


A single intake of Brazil nuts ( @ or @ g ) caused a significant decrease in serum IL-@ , IL-@ , TNF - , and IFN - levels ( P < @ ) , whereas serum levels of IL-@ were significantly increased ( P < @ ) .


The results indicate a long-term decrease in inflammatory markers after a single intake of large portions of Brazil nuts in healthy volunteers .


Therefore , the long-term effect of regular Brazil nut consumption on inflammatory markers should be better investigated .


We investigated the manifestations of pediatric loss of control ( LOC ) eating at different stages of pubertal development .


Participants were a nonclinical sample of @ youth ( @-@ years ) .


Physical examination determined pubertal stage .


LOC eating and disordered eating attitudes were assessed with the Eating Disorder Examination .


In a randomized crossover design , a subset ( n = @ ) ate ad libitum from two test meals designed to capture normal and LOC eating .


There were no differences in the prevalence rates or frequency of reported LOC eating episodes across pubertal stages ( ps@ @ ) .


There were , however , puberty by LOC eating interactions in disordered eating attitudes and palatable food consumption ( ps @ ) , even after adjusting for age and body composition .


LOC eating was associated with elevated global disordered eating attitudes , weight concern , and shape concern in post-pubertal youth ( ps @ ) , but not pre-pubertal youth ( ps @ ) .


In late-puberty , youth with LOC eating consumed less energy from protein ( p < @ ) and more from carbohydrate ( p = @ ) and snack-type foods ( p = @ ) than those without LOC eating , whereas endorsement of LOC eating in pre - or early-to-mid-puberty was not associated with differences in eating behavior ( ps@ @ ) .


Findings suggest that puberty may be a critical risk period , when LOC eating behaviors in boys and girls may become accompanied by greater weight and shape concerns and more obesogenic food consumption patterns .


Interventions for LOC eating during pre-puberty should be evaluated to determine if they are particularly beneficial for the prevention of exacerbated eating disorder psychopathology and adverse weight outcomes .


No significant differences in the number of immune aberrations were seen between children with or without severe recurrent acute otitis media ( rAOM ) ; however , subnormal values of immunological markers were found more often than expected , and @ of the @ children had treatment-requiring immune deficiencies .


Minor immunologic aberrations have been reported to be more frequent in children with rAOM .


Immune investigation is recommended in children with severe rAOM , defined as six or more AOM episodes per year .


The purpose of this study was to describe immunological findings in young children at high risk of developing rAOM , and to relate these to the number of expected aberrations and to the presence of severe rAOM .


A total of @ children at risk of developing rAOM were offered immune investigation including complement function , immunoglobulins with subclasses and cellular immunity .


Sixty patients were tested , @ of whom had severe rAOM and @ of whom did not develop rAOM .


Low levels of IgG@ ( @ % ) , C@q ( @ % ) and mannan-binding lectin ( @ % ) were found up to eight times as often as expected .


Although subnormal values were more frequent among children with severe rAOM , the study was too small to provide reliable evidence of any difference .


Four children were diagnosed with immune deficiencies that required treatment .


It is unknown whether young adults with bipolar disorder are able to benefit from early intervention combining optimised pharmacological treatment and group psychoeducation .


The aim of the present report was to compare the effects of early intervention among patients with bipolar disorder aged @-@ years to that of patients aged @ years or older .


Patients were randomised to early treatment in a specialised outpatient mood disorder clinic versus standard care .


The primary outcome was risk of psychiatric re-hospitalisation .


A total of @ patients with mania/bipolar disorder were included among whom @ ( @ % ) were between @ and @ years and @ patients were @ years or older .


For both age groups , the point estimate of the hazard ratio of re-hospitalisation was insignificantly decreased for patients treated in the mood disorder clinic versus standard treatment but more so for patients between @ and @ years ( HR @ , @ % CI @-@ @ ; p = @ ) than for patients @ years or older ( HR @ , @ % CI @-@ @ , p = @ ) .


Younger adults treated in the mood disorder clinic used mood stabilisers and antipsychotics more in contrast to those treated in standard care .


The differences between the estimates of effects did not reach significance in tests of interactions ( p > @ ) .


The study was based on a post hoc subgroup analysis and due to the small number of patients aged @-@ years , type II errors can not be excluded .


Although not statistically different , the observed differences of the point estimates was surprisingly larger for young adults suggesting that young adults with bipolar disorder may benefit even more than older adults from early intervention combining pharmacological treatment and group psychoeducation .


Antidepressants are frequently prescribed to treat functional dyspepsia ( FD ) , a common disorder characterized by upper abdominal symptoms , including discomfort or postprandial fullness .


However , there is little evidence of the efficacy of these drugs in patients with FD .


We performed a randomized , double-blind , placebo-controlled trial to evaluate the effects of antidepressant therapy on symptoms , gastric emptying ( GE ) , and meal-induced satiety in patients with FD .


We performed a study at @ North American sites of patients who met the Rome II criteria for FD and did not have depression or use antidepressants .


Patients ( n = @ ; @ @ years old , @ % were female , @ % with dysmotility-like FD , and @ % with ulcer-like FD ) were randomly assigned to groups given placebo , @ mg amitriptyline , or @ mg escitalopram for @ weeks .


The primary end point was adequate relief of FD symptoms for @ weeks of the last @ weeks ( of @ ) .


Secondary end points included GE time , maximum tolerated volume in Nutrient Drink Test , and FD-related quality of life .


An adequate relief response was reported by @ subjects given placebo ( @ % ) , @ given amitriptyline ( @ % ) , and @ given escitalopram ( @ % ) ( P = @ , after treatment , adjusted for baseline balancing factors including all subjects ) .


Subjects with ulcer-like FD given amitriptyline were > @-fold more likely to report adequate relief than those given placebo ( odds ratio = @ ; @ % confidence interval : @-@ @ ) .


Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the @-week period in any group .


Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE ( odds ratio = @ ; @ % confidence interval : @-@ @ ) .


Both antidepressants improved overall quality of life .


Amitriptyline , but not escitalopram , appears to benefit some patients with FD , particularly those with ulcer-like ( painful ) FD .


Patients with delayed GE do not respond to these drugs .


ClinicalTrials.gov ID : NCT@ .


Infectious complications and especially anastomotic leakage ( AL ) severely impede the recuperation of patients following colorectal cancer ( CRC ) surgery .


When the normal gut barrier fails , as in AL , pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality .


Moreover , AL has a negative impact on the CRC prognosis .


Selective decontamination of the digestive tract ( SDD ) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection .


In this multicentre randomised clinical trial , perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent .


The SDD regimen consists of colistin , tobramycin and amphotericin B.


The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications .


A main secondary objective is improvement of the cancer-free survival .


A total of @ patients will be included in total for sufficient power .


It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients .


Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer ( NSCLC ) .


We compared afatinib with gemcitabine and cisplatin-a chemotherapy regimen widely used in Asia-for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC .


This open-label , randomised phase @ trial was done at @ centres in China , Thailand , and South Korea .


After central testing for EGFR mutations , treatment-naive patients ( stage IIIB or IV cancer -LSB- American Joint Committee on Cancer version @ -RSB- , performance status @-@ ) were randomly assigned ( @:@ ) to receive either oral afatinib ( @ mg per day ) or intravenous gemcitabine @ mg/m ( @ ) on day @ and day @ plus cisplatin @ mg/m ( @ ) on day @ of a @-week schedule for up to six cycles .


Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system .


Randomisation was stratified by EGFR mutation ( Leu@Arg , exon @ deletions , or other ; block size three ) .


Clinicians and patients were not masked to treatment assignment , but the independent central imaging review group were .


Treatment continued until disease progression , intolerable toxic effects , or withdrawal of consent .


The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .


This study is registered with ClinicalTrials.gov , NCT@ .


@ patients were screened and @ were randomly assigned ( @ to afatinib , @ to gemcitabine and cisplatin ) .


Median progression-free survival was significantly longer in the afatinib group ( @ months , @ % CI @-@ ) than in the gemcitabine and cisplatin group ( @ months , @-@ ; hazard ratio @ , @ % CI @-@ ; p < @ ) .


The most common treatment-related grade @ or @ adverse events in the afatinib group were rash or acne ( @ -LSB- @ % -RSB- of @ patients ) , diarrhoea ( @ -LSB- @ % -RSB- ) , and stomatitis or mucositis ( @ -LSB- @ % -RSB- ) , compared with neutropenia ( @ -LSB- @ % -RSB- of @ patients ) , vomiting ( @ -LSB- @ % -RSB- ) , and leucopenia ( @ -LSB- @ % -RSB- ) in the gemcitabine and cisplatin group .


Treatment-related serious adverse events occurred in @ ( @ % ) patients in the afatinib group and nine ( @ % ) patients in the gemcitabine and cisplatin group .


First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC .


Afatinib should be considered as a first-line treatment option for this patient population .


Physical inactivity and advanced age are associated with risk of depressive disorders .


Physical activity can reduce depressive symptoms in older subjects with depressive disorders .


We investigated whether a walking intervention program may decrease the occurrence of depressive symptoms in inactive post-menopausal women without depression .


A total of @ participants aged @-@ years were randomly assigned to a six-month moderate intensity walking intervention ( three times a week , @ minutes per session , supervised and home-based ) or to a control group ( waiting list ) .


Inactivity was assessed using the Physical Activity Questionnaire for the Elderly .


Depression levels were measured pre - and post-intervention with the Beck depression inventory ( BDI ) .


Several baseline measures were considered as possible predictors of post-intervention BDI score .


Participants in the walking intervention showed a significant decrease in depression as compared with controls .


Baseline cognitive-BDI subscore , subjective health status , body mass index and adherence were post-intervention BDI score predictors .


A six-month , three-session per week , moderate intensity walking intervention with a minimal @ % adherence rate reduces depression in post-menopausal women at risk for depression due to physical inactivity .


This type of walking intervention could be considered as a widely accessible prevention strategy to prevent depressive symptoms in post-menopausal women at risk of depression .


The purpose of this study was to evaluate the efficacy and safety of duloxetine fixed dose in the treatment of children ( @-@ years ) and adolescents ( @-@ years ) with major depressive disorder ( MDD ) .


Patients ( n = @ ) in this @ week study ( @ week acute and @ week extension treatment ) received duloxetine @mg QD ( n = @ ) , duloxetine @mg QD ( n = @ ) , fluoxetine @mg QD ( n = @ , active control ) , or placebo ( n = @ ) .


Measures included : Children 's Depression Rating Scale-Revised ( CDRS-R ) , treatment-emergent adverse events ( TEAEs ) , and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .


Neither active drug ( duloxetine or fluoxetine ) separated significantly ( p < @ ) from placebo on mean change from baseline to end-point ( @ weeks ) on the CDRS-R total score .


Total TEAEs and discontinuation for AEs were significantly ( p < @ ) higher only for the duloxetine @mg group versus the placebo group during acute treatment .


No clinically significant electrocardiogram ( ECG ) or laboratory abnormalities were observed , and no completed suicides or deaths occurred during the study .


A total of @ ( @ % ) duloxetine @mg , @ ( @ % ) duloxetine @mg , @ ( @ % ) fluoxetine , and @ ( @ % ) placebo patients had worsening of suicidal ideation from baseline during acute treatment .


Of the patients with suicidal ideation at baseline , @/@ ( @ % ) duloxetine @mg , @/@ ( @ % ) duloxetine @mg , @/@ ( @ % ) fluoxetine , and @/@ ( @ % ) placebo had improvement in suicidal ideation at end-point during acute treatment .


One fluoxetine , one placebo , and six duloxetine patients had treatment-emergent suicidal behavior during the @ week study .


Trial results were inconclusive , as neither the investigational drug ( duloxetine ) nor the active control ( fluoxetine ) separated from placebo on the CDRS-R at @ weeks .


No new duloxetine safety signals were identified relative to those seen in adults .


Clinical Trial Registry Number ( www.ClinicalTrials.gov ) : NCT@ .


The aim of this study was to evaluate early complications following retromuscular mesh repair with those after dual layer suture of the anterior rectus sheath in a randomised controlled clinical trial for abdominal rectus muscle diastasis ( ARD ) .


Patients with an ARD wider than @ cm and clinical symptoms related to the ARD were included in a prospective randomised study .


They were assigned to either retromuscular inset of a lightweight polypropylene mesh or to dual closure of the anterior rectus fascia using Quill self-locking technology .


All patients completed a validated questionnaire for pain assessment ( Ventral Hernia Pain Questionnaire , VHPQ ) and for quality of life ( SF@ ) prior to and @ months after surgery .


The most frequently seen adverse event was minor wound infection .


Of the patients , @/@ had a superficial wound infection ; five related to Quill and nine to mesh repair .


No deep wound infections were reported .


Patient rating for subjective muscular improvement postoperatively was better in the mesh technique group with a mean of @ ( range @-@ ) compared to a mean of @ ( range @-@ ) in the Quill group ( p = @ ) .


The pre - and post-operative SF@ scores improved in both groups .


There was no significant difference between the two surgical techniques in terms of early complications and perceived pain at the @-month follow-up .


Both techniques may be considered equally reliable for ARD repair in terms of adverse outcomes during the early postoperative phase , even though patients operated with a mesh experienced better improvement in muscular strength .


ClinicalTrial.gov : @/@ -@ / @/PE/@ .


The study aims were @ ) to describe the proportions of individuals who met criteria for melancholic , atypical , and anxious depressive subtypes , as well as subtype combinations , in a large sample of depressed outpatients , and @ ) to compare subtype profiles on remission and change in depressive symptoms after acute treatment with one of three antidepressant medications .


Participants @-@ years of age ( N = @,@ ) who met criteria for major depressive disorder were randomly assigned to @ weeks of treatment with escitalopram , sertraline , or extended-release venlafaxine .


Participants were classified by subtype .


Those who met criteria for no subtype or multiple subtypes were classified separately , resulting in eight mutually exclusive groups .


A mixed-effects model using the intent-to-treat sample compared the groups ' symptom score trajectories , and logistic regression compared likelihood of remission ( defined as a score @ on the @-item Quick Inventory of Depressive Symptomatology-Self-Report ) .


Thirty-nine percent of participants exhibited a pure-form subtype , @ % met criteria for more than one subtype , and @ % did not meet criteria for any subtype .


All subtype groups exhibited a similar significant trajectory of symptom reduction across the trial .


Likelihood of remission did not differ significantly between subtype groups , and depression subtype was not a moderator of treatment effect .


There was substantial overlap of the three depressive subtypes , and individuals in all subtype groups responded similarly to the three antidepressants .


The consistency of these findings with those of the Sequenced Treatment Alternatives to Relieve Depression trial suggests that subtypes may be of minimal value in antidepressant selection .


Tuberculosis is epidemic among workers in South African gold mines .


We evaluated an intervention to interrupt tuberculosis transmission by means of mass screening that was linked to treatment for active disease or latent infection .


In a cluster-randomized study , we designated @ clusters with @,@ miners as either intervention clusters ( @,@ miners in @ clusters ) or control clusters ( @,@ miners in @ clusters ) .


In the intervention clusters , all miners were offered tuberculosis screening .


If active tuberculosis was diagnosed , they were referred for treatment ; if not , they were offered @ months of isoniazid preventive therapy .


The primary outcome was the cluster-level incidence of tuberculosis during the @ months after the intervention ended .


Secondary outcomes included tuberculosis prevalence at study completion .


In the intervention clusters , @,@ miners ( @ % ) underwent screening .


Of these miners , @,@ ( @ % ) started taking isoniazid , and isoniazid was dispensed for @ months or more to @ to @ % of miners , depending on the cluster .


The intervention did not reduce the incidence of tuberculosis , with rates of @ per @ person-years in the intervention clusters and @ per @ person-years in the control clusters ( rate ratio in the intervention clusters , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ; adjusted rate ratio , @ ; @ % CI , @ to @ ; P = @ ) , or the prevalence of tuberculosis ( @ % vs. @ % ; adjusted prevalence ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Analysis of the direct effect of isoniazid in @,@ miners showed a reduced incidence of tuberculosis during treatment ( @ cases per @ person-years among miners receiving isoniazid vs. @ cases per @ person-years among controls ; adjusted rate ratio , @ ; @ % CI , @ to @ ; P = @ ) , but there was a subsequent rapid loss of protection .


Mass screening and treatment for latent tuberculosis had no significant effect on tuberculosis control in South African gold mines , despite the successful use of isoniazid in preventing tuberculosis during treatment .


( Funded by the Consortium to Respond Effectively to the AIDS TB Epidemic and others ; Thibela TB Current Controlled Trials number , ISRCTN@ . )


Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity , specifically - T cell proliferation , after daily consumption of a cranberry beverage , and its effect on health outcomes related to cold and influenza symptoms .


The study was a randomized , double-blind , placebo-controlled , parallel intervention .


Subjects drank a low calorie cranberry beverage ( @ ml ) made with a juice-derived , powdered cranberry fraction ( n = @ ) or a placebo beverage ( n = @ ) , daily , for @ wk .


PBMC were cultured for six days with autologous serum and PHA-L stimulation .


Cold and influenza symptoms were self-reported .


The proliferation index of - T cells in culture was almost five times higher after @ wk of cranberry beverage consumption ( p < @ ) .


In the cranberry beverage group , the incidence of illness was not reduced , however significantly fewer symptoms of illness were reported ( p = @ ) .


Consumption of the cranberry beverage modified the ex vivo proliferation of - T cells .


As these cells are located in the epithelium and serve as a first line of defense , improving their function may be related to reducing the number of symptoms associated with a cold and flu .


Neonates at risk for early-onset sepsis are started on antibiotics empirically .


Antibiotic resistance to conventionally used antibiotics is increasingly being reported .


Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth , limiting the planning of antibiotics based on culture reports .


A head-to-head comparison for selecting the appropriate antibiotic is one strategy .


To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis .


Randomized open-label controlled trial with stratification and block randomization .


Tertiary care neonatal unit in India


All consecutive inborn neonates delivered between @ May @ and @ April @ who were @ week gestation and/or @ g birth weight with risk factors for early-onset sepsis .


Randomized to receive either amikacin or piperacillin-tazobactum , after stratifying as asymptomatic or symptomatic within @ h of birth .


Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness , necessitating a change of antibiotic .


Of @ eligible cases , @ were enrolled .


Seventeen babies were excluded .


A total of @ neonates were stratified as asymptomatic and @ as symptomatic .


In all , @ of the asymptomatic cases received amikacin and @ received piperacillin-tazobactum , while @ symptomatic babies received amikacin and @ received piperacillin-tazobactum .


Five babies had blood culture-positive sepsis , and @ babies had strong suspicion of sepsis .


There was no difference in the treatment failure in the amikacin group ( @ of @ ; @ % ) compared with piperacillin-tazobactum group ( @ of @ ; @ % ) ( p > @ ) and no difference in the incidence of second infection , fungal sepsis and all-cause mortality at day @ and @ between the two study groups ( p > @ ) .


Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum .


Both antibiotics were effective in management of babies with early-onset sepsis .


The level of anticoagulation in response to a fixed-dose regimen of warfarin is difficult to predict during the initiation of therapy .


We prospectively compared the effect of genotype-guided dosing with that of standard dosing on anticoagulation control in patients starting warfarin therapy .


We conducted a multicenter , randomized , controlled trial involving patients with atrial fibrillation or venous thromboembolism .


Genotyping for CYP@C@ * @ , CYP@C@ * @ , and VKORC@ ( -@ GA ) was performed with the use of a point-of-care test .


For patients assigned to the genotype-guided group , warfarin doses were prescribed according to pharmacogenetic-based algorithms for the first @ days .


Patients in the control ( standard dosing ) group received a @-day loading-dose regimen .


After the initiation period , the treatment of all patients was managed according to routine clinical practice .


The primary outcome measure was the percentage of time in the therapeutic range of @ to @ for the international normalized ratio ( INR ) during the first @ weeks after warfarin initiation .


A total of @ patients were recruited , with @ randomly assigned to the genotype-guided group and @ assigned to the control group .


The mean percentage of time in the therapeutic range was @ % in the genotype-guided group as compared with @ % in the control group ( adjusted difference , @ percentage points ; @ % confidence interval , @ to @ ; P < @ ) .


There were significantly fewer incidences of excessive anticoagulation ( INR @ ) in the genotype-guided group .


The median time to reach a therapeutic INR was @ days in the genotype-guided group as compared with @ days in the control group ( P < @ ) .


Pharmacogenetic-based dosing was associated with a higher percentage of time in the therapeutic INR range than was standard dosing during the initiation of warfarin therapy .


( Funded by the European Commission Seventh Framework Programme and others ; ClinicalTrials.gov number , NCT@ . )


Subjective response to alcohol represents a marker of alcoholism risk .


The A@G single-nucleotide polymorphism ( SNP ) of the mu opioid receptor ( OPRM@ ) gene has been associated with subjective response to alcohol .


Recently , the dopamine transporter ( DAT@ ) variable number of tandem repeat ( VNTR ; SLC@A@ ) has been found to interact with the OPRM@ A@G SNP in predicting neural and behavioral responses to naltrexone and to alcohol .


This exploratory study examines the OPRM@ DAT@ interaction on subjective responses to alcohol .


Non-treatment-seeking problem drinkers ( n = @ ) were assessed in the laboratory for alcohol dependence .


Following prospective genotyping for the OPRM@ gene , @ alcohol-dependent individuals were randomized to two intravenous infusion sessions , one of alcohol ( target BrAC = @ g/dl ) and one of saline .


Measures of subjective responses to alcohol were administered in both infusion sessions .


Analyses revealed significant Alcohol OPRM@ DAT@ interactions for alcohol-induced stimulation , vigor and positive mood as well as significant Alcohol OPRM@ DAT@ Time interactions for stimulation and positive mood .


These effects were such that , compared with other genotype groups , OPRM@ G-allele carriers + DAT@ A@ homozygotes reported steeper increases in stimulation and positive mood across rising BrAC , when compared with placebo .


All Alcohol OPRM@ DAT@ interactions remained significant when analyses were restricted to a subsample of Caucasian participants ( n = @ ) ; however , @-way interactions did not reach statistical significance in this subsample .


This study suggests that the contribution of OPRM@ genotype to alcohol-induced stimulation , vigor and positive mood is moderated by DAT@ genotype .


These findings are consistent with the purported interaction between opioidergic and dopaminergic systems in determining the reinforcing properties of alcohol .


Women with late preterm premature rupture of membranes ( PROM ) have an increased risk that their child will develop neonatal sepsis .


We evaluated whether neonatal sepsis can be predicted from antepartum parameters in these women .


We used multivariable logistic regression to develop a prediction model .


Data were obtained from two recent randomized controlled trials on induction of labor versus expectant management in late preterm PROM ( PPROMEXIL trials , ( ISRCTN@ and ISRCTN@ ) .


Data from randomized as well as non-randomized women , who consented to the use of their medical data , were used .


We evaluated @ potential antepartum predictors for neonatal sepsis .


Missing data were imputed .


Discriminative ability of the model was expressed as the area under the receiver operating characteristic ( ROC ) curve and a calibration with both a calibration plot and the Hosmer and Lemeshow goodness-of-fit test .


Overall performance of the prediction model was quantified as the scaled Brier score .


We studied @ women .


Thirty-three ( @ % ) neonates suffered neonatal sepsis .


Maternal age ( OR @ per year ) , maternal CRP level ( OR @ per mmol/l ) , maternal temperature ( OR @ per C ) and positive GBS culture ( OR @ ) were associated with an increased risk of neonatal sepsis .


The model had an area under the ROC-curve of @ .


The model had both a good calibration and accuracy .


Antepartum parameters aid in the more precise prediction of the risk of neonatal sepsis in women with late preterm PPROM .


The Canadian Fabry disease initiative ( CFDI ) tracks outcomes of subjects with Fabry disease treated enzyme replacement therapy ( ERT ) given to subjects who meet evidence-based treatment guidelines and cardiovascular risk factor modification .


We report @ year follow-up data on @ subjects for a composite endpoint ( death , neurologic or cardiovascular events , development of end-stage renal disease or sustained increase in serum creatinine of @ % from baseline ) .


At enrollment , @ subjects had previously received ERT ( Cohort @a ) and @ subjects were newly started ( Cohort @b ) and randomized to agalsidase alfa or agalsidase beta .


@ subjects did not initially meet ERT criteria ( Cohort @c ) , @ of whom met ERT criteria in follow-up and were moved to Cohort @b ( total N = @ ERT treated subjects ) .


Use of supportive therapies such as aspirin ( @ % ) , renin-angiotensin blockade ( @ % ) , and statins ( @ % ) was common in ERT treated subjects .


In Cohort @a , @ subjects met the composite endpoint with @ deaths .


In Cohort @b , @ subjects met the composite endpoint with @ death .


Cohort @b had fewer clinical events than Cohort @a ( p = @ ) suggesting that the treatment protocol was effective in targeting subjects at an earlier stage .


@ % of Cohort @b subjects on agalsidase alfa and @ % on agalsidase beta had a clinical event ( p = @ ) .


@ Cohort @c subjects had clinical events , none of which would have been prevented by earlier use of ERT .


Cardiovascular risk factor modification and targeted use of ERT reduce the risk of adverse outcomes related to Fabry disease .


Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control .


However , to our knowledge the comparative effectiveness of these approaches has not been established .


We evaluated functional and oncologic outcomes in patients undergoing these procedures .


We performed a single institution trial in patients with bladder cancer in whom transurethral prostatic urethral biopsy and transrectal prostate biopsy were negative .


Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score ( greater than @ vs @ or less ) .


Our primary end point was @-month overall urinary function as measured by Bladder Cancer Index .


Secondary end points included sexual function , cancer control and complications .


A total of @ patients were enrolled in the study with @ patients in each arm .


Urinary function at @ months decreased by @ and @ points in the prostate capsule and nerve sparing groups , respectively ( p = @ ) .


Sexual function followed a similar pattern ( p = @ ) .


There was no difference in recurrence-free , metastasis-free or overall survival ( each p > @ ) .


The rate of incidentally detected prostate cancer was similar ( p = @ ) .


Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques .


We found no difference in functional or oncologic outcomes between the @ approaches , although our study was underpowered due to a lack of patient accrual .


Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer , an exploratory analysis was performed to investigate the effect of age in these patients .


Data were pooled from two single-arm phase II studies and one open-label randomized phase III study in which patients received eribulin mesylate at @ mg/m ( @ ) as @ - to @-minute intravenous infusions on days @ and @ of a @-day cycle .


The effect of age on median overall survival ( OS ) , progression-free survival ( PFS ) , overall response rate ( ORR ) , clinical benefit rate ( CBR ) , and incidence of adverse events ( AEs ) was calculated for four age groups ( < @ years , @-@ years , @-@ years , @ years ) .


RESULTS .


Overall , @ patients were included in the analysis ( < @ years , n = @ ; @-@ years , n = @ ; @-@ years , n = @ ; @ years , n = @ ) .


Age had no significant impact on OS ( @ months , @ months , @ months , and @ months , respectively ; p = @ ) , PFS ( @ months , @ months , @ months , and @ months , respectively ; p = @ ) , ORR ( @ % , @ % , @ % , and @ % , respectively ) , or CBR ( @ % , @ % , @ % , and @ % , respectively ) .


Although some AEs had higher incidence in either the youngest or the oldest subgroup , there was no overall effect of age on the incidence of AEs ( including neuropathy , neutropenia , and leukopenia ) .


Eribulin monotherapy in these selected older patients with good baseline performance status led to OS , PFS , ORR , CBR , and tolerability similar to those of younger patients with metastatic breast cancer .


The benefits and risks of eribulin appear to be similar across age groups .


To evaluate the efficacy , tolerability , and safety of once-daily @ mg and @ mg SPN-@ ( Oxtellar XR , Supernus Pharmaceuticals ) , an extended-release tablet formulation of oxcarbazepine ( OXC ) , added to @-@ concomitant antiepileptic drugs ( AEDs ) in adults with refractory partial-onset seizures , with or without secondary generalization .


The Prospective , Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory ( PROSPER ) study was a multinational , randomized , double-blind , parallel-group Phase @ study .


The primary efficacy endpoint was median percent reduction from baseline in monthly ( @-day ) seizure frequency for the @-week double-blind treatment period in the intent-to-treat ( ITT ) population with analyzable seizure data .


Other efficacy analyses included proportion of patients with @ % seizure reduction , proportion of patients seizure free , and the relationship between clinical response and plasma concentration .


Median percent reduction was -@ % for placebo , -@ % ( P = @ vs placebo ) for once-daily SPN-@ @ mg , and -@ % ( P = @ ) for SPN-@ @ mg .


Responder rates were @ % , @ % ( P = @ ) , and @ % ( P = @ ) ; @-week seizure-free rates in a pragmatic ITT analysis were @ % , @ % ( P = @ ) , and @ % ( P = @ ) , respectively .


When data were analyzed separately for study site clusters , a post hoc analysis demonstrated that both SPN-@ dosages were significantly superior to placebo in median percent seizure reduction ( placebo : -@ % ; @ mg : -@ % , P = @ ; @ mg : -@ % , P = @ ) in the North American study site cluster .


A concentration-response analysis also supported a clinically meaningful effect for @ mg .


Adverse event types reflected the drug 's established profile .


Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-@ produces lower peak plasma concentrations vs immediate-release OXC .


Once-daily dosing was not associated with any new safety signals .


Adjunctive once-daily SPN-@ improved seizure control in patients with inadequately controlled partial-onset seizures .


Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediate-release OXC .


Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients ' perspective .


The current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among @ Black and White adults participating in a multisite randomized clinical trial ( RCT ) of Motivational Enhancement Therapy .


Throughout the @-week RCT , participants self-reported substance use .


Upon completion of treatment , participants completed a self-report measure assessing the perceived helpfulness of treatment components .


Black participants rated @ out of @ treatment components ( e.g. , `` learning skills that will help me cope with my problems '' ) as being more helpful than their White counterparts , even after controlling for age , gender , employment status , primary drug type , and treatment assignment .


However , perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants .


Clients ' perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment , especially for Black adults .


To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease ( COPD ) patients with chronic periodontitis ( CP ) .


In a pilot randomized controlled trial , @ COPD patients with CP were randomly assigned to receive scaling and root planing ( SRP ) treatment , supragingival scaling treatment , or oral hygiene instructions only with no periodontal treatment .


We evaluated their periodontal indexes , respiratory function , and COPD exacerbations at baseline , @months , @ , and @years .


Compared with the control group , measurements of periodontal indexes were significantly improved in patients in two treatment groups at @-month , @-year , and @-year follow-up ( all p < @ ) .


Overall , the means of forced expiratory volume in the first second/forced vital capacity ( FEV@/FVC ) and FEV@ were significantly higher in the two therapy groups compared with the control group during the follow-up ( p < @ ) .


In addition , the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at @-year follow-up ( p < @ ) .


Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation .


Arterial punctures are important procedures performed by emergency physicians in the assessment of ill patients .


However , arterial punctures are painful and can create anxiety and needle phobia in patients .


The pain score of radial arterial punctures were compared between the insulin needle and the standard @-gauge hypodermic needle .


In a randomized controlled crossover design , healthy volunteers were recruited to undergo bilateral radial arterial punctures .


They were assigned to receive either the insulin or the standard needle as the first puncture , using blocked randomization .


The primary outcome was the pain score measured on a @-mm visual analogue scale ( VAS ) for pain , and secondary outcomes were rate of hemolysis , mean potassium values , and procedural complications immediately and @ hours postprocedure .


Fifty healthy volunteers were included in the study .


The mean ( standard deviation ) VAS score in punctures with the insulin needle was lower than the standard needle ( @ @ mm vs. @ @ mm ; mean difference = -@ mm ; @ % confidence interval = -@ mm to -@ mm ; p < @ ) .


The rates of hemolysis and mean potassium value were greater in samples obtained using the insulin needle compared to the standard needle ( @ % vs. @ % , p = @ ; and @ @ mmol/L vs. @ @ mmol/L , p = @ ) .


Procedural complications were lower in punctures with the insulin needle both immediately postprocedure ( @ % vs. @ % ; p < @ ) and at @ hours postprocedure ( @ % vs. @ % ; p = @ ) .


Arterial punctures using insulin needles cause less pain and fewer procedural complications compared to standard needles .


However , due to the higher rate of hemolysis , its use should be limited to conditions that do not require a concurrent potassium value in the same blood sample .


Remifentanil is widely used for monitored anesthesia care in spontaneously breathing patients .


However , the authors ' previous studies have shown that remifentanil induces subjective swallowing difficulties , which may increase the risk of aspiration .


Twenty-five healthy volunteers participated in a double-blind , randomized , crossover trial at the University Hospital in rebro , rebro , Sweden .


The volunteers were studied on two different occasions during which they received either remifentanil with an effect-site target concentration of @ ng/ml or saline over @ h.


A radionuclide tracer was infused simultaneously into the nasopharynx at a rate of @ ml/min .


Aspiration was determined by lung scans , and subjective swallowing difficulties and grip strength were evaluated .


The primary outcome was the difference in occurrence of aspiration between remifentanil and placebo treatments .


The secondary outcomes were differences in swallowing difficulty and grip strength and the association between aspiration and swallowing difficulty .


During remifentanil and placebo infusion , @ and @ % of the volunteers aspirated , respectively , difference : @ % ( @ % CI , @ to @ % ) .


A similar significant difference was found for swallowing difficulties but not for the association between aspiration and swallowing .


No difference was found in grip strength between the two treatments .


Remifentanil infusion at concentrations used in monitored anesthesia care increases the incidence of aspiration .


However , the subjective swallowing difficulty induced by remifentanil is not indicative of the aspiration risk .


Vitamin D modulates the immune response and blocks induction of an interferon ( IFN ) signature by systemic lupus erythematosus ( SLE ) sera .


This study was undertaken to investigate the effects of vitamin D supplementation on the IFN signature in patients with SLE .


SLE patients ( n = @ ) with stable , inactive disease , a serum @-hydroxyvitamin D ( @ -LSB- OH -RSB- D ) level @ ng/ml , an elevated anti-double-stranded DNA antibody level , and an IFN signature ( as determined by measuring the expression levels of @ IFN response genes ) were randomized into a @-week double-blind , placebo-controlled trial of vitamin D@ at doses of @,@ IU or @,@ IU .


An IFN signature response was defined as a @ % reduction in the expression of @ of the @ genes or a @ % reduction in the expression of @ of the @ genes .


Disease activity , adverse events , and endocrine effects were assessed .


Baseline characteristics of the patients in the @ treatment groups ( placebo , low-dose vitamin D@ , or high-dose vitamin D@ ) were similar .


Repletion of @ ( OH ) D ( i.e. , levels @ ng/ml ) was not observed in any of the patients who were receiving placebo , while repletion was observed in @ of @ patients receiving vitamin D@ .


The percentage of patients with an IFN signature response did not differ among the treatment groups .


Moreover , there was no difference in the percentage of patients with an IFN signature response between those who remained vitamin D deficient and those who demonstrated repletion of vitamin D. Modular microarray analysis of a subset of patients ( n = @ ) did not reveal changes from baseline in any modules ( including the IFN-inducible module ) in any of the treatment groups , and no differences in expression were found between patients who demonstrated vitamin D repletion and patients who were persistently vitamin D deficient .


Vitamin D@ was well tolerated , and there were no safety concerns .


Vitamin D@ supplementation up to @,@ IU daily was safe and well-tolerated but failed to diminish the IFN signature in vitamin D-deficient SLE patients .


Higher @ ( OH ) D levels sustained for a longer duration may be required to affect immunologic outcomes .


Distal radius fractures are among the most common fractures seen in the hospital emergency department .


Of these , over @ % are considered unstable and require some form of fixation .


In recent years with the advent of low profile plating , open reduction and internal fixation ( ORIF ) using volar plates has become the surgical treatment of choice in many hospitals .


However , it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery .


Few studies have compared different types of plates , which may have various features , different plate and screw designs or may be manufactured from different materials ( for example , stainless steel or titanium ) .


This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures : one made from stainless steel ( Trimed Volar Plate , Trimed , California , USA ) and the other made from titanium ( Medartis Aptus Volar Plate , Medartis , Basel , Switzerland ) .


The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture .


This study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates : one plate manufactured from stainless steel ( Trimed Volar Plate ) and one plate manufactured from titanium ( Medartis Aptus Volar Plate ) .


The surgery will be performed at a major trauma hospital in Brisbane , Australia .


Outcome measures including function , adverse events , range of movement , strength , disability , radiological findings and health-related quality of life will be collected at @ weeks , @ , @ , @ and @ months following surgery .


A parallel economic analysis will also be performed .


This randomized clinical trial is due to deliver results in December @ .


Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type .


To compare corneal sensation and self-reported dry eye symptoms after femtosecond-assisted LASIK with conventional versus inverted side cuts .


Prospective , randomized , eye-to-eye study .


A total of @ eyes in @ participants with myopia .


Fellow eyes were randomized to receive femtosecond-assisted LASIK with a conventional @-degree side cut made with the @ kHz IntraLase FS ( Abbott Medical Optics , Santa Ana , CA ) or an inverted @-degree side cut made with the @ kHz IntraLase iFS ( Abbott Medical Optics ) .


Cochet-Bonnet aesthesiometry ( Luneau Ophthalmologia , Chartes , France ) measured corneal sensation ( @ mm = normal sensation ; < @ mm = depressed sensation ) preoperatively and at postoperative months @ , @ , @ , and @ .


Participants also completed serial dry eye surveys using the same subscales ( frequency , severity , bothersome ) as the validated , Rasch-tested , linear-scaled Quality of Vision questionnaire .


Objective corneal sensation and self-reported light sensitivity , dryness , foreign body sensation , and pain/discomfort .


Preoperative corneal sensation as measured by mean Cochet-Bonnet aethesiometry was equal between the inverted and conventional side cut groups but was better in eyes with an inverted side cut compared with a conventional side cut at all postoperative months ( inverted vs. conventional : @ month , @ vs. @ mm ; @ months , @ vs. @ mm ; @ months , @ vs. @ mm ; @ months , @ vs. @ mm ; all P @ ) .


None of the subjective dry eye parameters demonstrated statistically significant differences between the groups at any time point .


The LASIK flaps with an inverted side cut are associated with superior recovery of corneal sensation compared with flaps with a conventional side cut during the first postoperative year ; however , this may not translate to significant improvements in subjective dry eye symptoms .


This trial was designed to compare levonorgestrel intrauterine device ( LNG-IUD ) use at @ year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion @-@ weeks after delivery .


This randomized controlled trial was conducted at two urban medical centers .


Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after @-@ weeks .


We used intention-to-treat analysis for the primary outcome of LNG-IUD use @ months after delivery .


Forty-two women were randomized , @ into the postplacental group and @ in the delayed group .


Although confirmed use of the LNG-IUD @ months after delivery was higher in the postplacental group ( @ % vs. @ % , p = @ ) , this difference was not statistically significance .


Expulsion was significantly more common in the postplacental group ( @ % vs. @ % , p = @ ) .


There were significant differences between the two sites in baseline population characteristics , follow-up and expulsion .


The trial did not answer the intended question as it was halted early due to slow enrollment .


Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at @ months .


Moreover , it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion .


Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period .


While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at @ months , our trial was insufficient to definitively test our hypothesis .


To investigate the effect of adding segmental epidural steroid injections ( SESIs ) to usual care compared with usual care alone on quality of life and cost utility in lumbosacral radicular syndrome ( LRS ) in general practice .


A pragmatic randomized controlled trial .


Results were analyzed using mixed models .


Primary care .


Patients ( N = @ ) in the acute phase of LRS .


One epidural injection containing @mg of triamcinolone in normal saline .


Back pain at @ weeks after the start of the treatment .


Both groups experienced a significant increase in quality of life in ( especially ) the physical domains of the Medical Outcomes Study @-Item Short-Form Health Survey .


The intervention group scored significantly better than the control group at certain time points in the physical domain .


The differences were small .


The cost-utility analysis showed that with a negligible loss of utility ( @d in perfect health ) , societal costs ( @,@ euros per quality-adjusted life year lost ) would be saved because of more productivity in the intervention group .


Although the beneficial effects of SESIs are small and the natural course of LRS is predominantly favorable , we think decision makers can consider implementing SESIs in daily practice with the purpose of saving resources .


Caution must be taken , and further research should be directed at identifying patient subgroups who might benefit from SESIs , with additional focus on ( costs of ) complications and adverse effects .


To test the hypothesis that a semi-quantitative echocardiographic calcium score ( eCS ) significantly correlates with cardiac calcium measured by coronary computed tomography angiography ( CCTA ) and , secondarily , severe coronary artery calcifications and stenosis .


This is a retrospective , observational study , conducted in a tertiary centre .


eCS was compared with CCTA scores of non-coronary cardiac calcium ( nCACS ) , coronary cardiac calcium ( CACS ) and number of diseased coronary vessels , in @ subjects without known coronary artery disease ( CAD ) , who underwent both echocardiography and CCTA for clinical reasons .


Age , prevalence of hypertension and all measures of calcium ( eCS , nCACS and CACS ) differed significantly between the no-CAD and CAD subgroups .


eCS was positively correlated with nCACS ( Spearman rho = @ , p < @ ) , CACS ( rho = @ , p < @ ) and weakly with the number of diseased coronary vessels ( rho = @ , p < @ ) .


eCS and nCACS had similar area under the curve ( AUC ) for the prediction of severe CACS ( @ ) ( @ , @ % CI @-@ @ and @ , @ % CI @-@ @ ) or obstructive CAD ( @ , @ % CI @-@ @ and @ , @ % CI @-@ @ ) .


eCS , a calcium score easily obtainable during standard echocardiography , is moderately to strongly correlated with nCACS by CCTA .


The full eCS score correlates with nCACS better than its single components .


It correlates with CACS and predicts severe coronary calcification ( CACS > @ ) , a known predictor of cardiovascular morbidity and mortality .


The eCS also predicts obstructive CAD , incrementally to age and clinical variables , although for this purpose CACS remains the most accurate score .


As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups .


We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity .


In Study @ , @ female undergraduates ( M age = @ , SD = @ ) were randomized to clinician-led Body Project groups or an educational control group .


In Study @ , @ female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition .


Although there was some variation in risk factor scores across ethnic groups , ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants .


Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial .


There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity .


Results suggest that the Body Project is similarly effective for African American , Asian American , European American , and Hispanic female college students , and when participants and facilitators are matched or not on minority ethnicity status , implying that this prevention program can be broadly disseminated in this population .


There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors .


Using data from ROCKET AF , we analysed the management and outcomes of major bleeding overall and according to the randomized treatment .


During a median follow-up of @ years , @ ( @ % ) patients experienced major bleeding at a rate of @ events/@ patient-years with a similar event rate in each arm ( n = @ rivaroxaban vs. n = @ warfarin ) .


The median number of transfused packed red blood cells ( PRBC ) per episode was similar in both arms -LSB- @ ( @th , @th : @ , @ ) units -RSB- .


Overall , few transfusions of whole blood ( n = @ ) , platelets ( n = @ ) , or cryoprecipitate ( n = @ ) were used .


Transfusion of fresh frozen plasma ( FFP ) was significantly less in the rivaroxaban arm ( n = @ vs. n = @ units ) after adjustment for covariates -LSB- odds ratio ( OR ) @ ( @ % CI @-@ @ ) ; P < @ -RSB- .


Prothrombin complex concentrates ( PCC ) were administered less in the rivaroxaban arm ( n = @ vs. n = @ ) .


Outcomes after major bleeding , including stroke or non-central nervous system embolism ( @ % rivaroxaban vs. @ % warfarin ; HR @ ; @ % CI @-@ @ ) and all-cause death ( @ % rivaroxaban vs. @ % warfarin ; HR @ , @ % CI @-@ @ ) were similar in patients treated with rivaroxaban and warfarin ( interaction P = @ and @ ) .


Among high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF , the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin .


However , use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin .


Remote ischemic preconditioning ( RIPC ) has been suggested to induce cardioprotection during cardiac surgery .


Maintaining proper atrial function is imperative in preventing arrhythmia and thrombus formation .


Mitochondria have been proposed as key targets in conveying RIPC mechanisms and effects .


MicroRNA ( miR ) is emerging as an important regulator of mitochondrial function , arrhythmia , and protection from ischemia and reperfusion .


This study aimed to evaluate the effect of RIPC on mitochondrial respiration and miR expression in human atrial tissue .


Sixty patients undergoing coronary artery bypass graft surgery were randomized to RIPC ( n = @ ) or control ( n = @ ) .


RIPC was performed preoperatively by inflating a blood pressure cuff on the upper arm to @ mm Hg for @ minutes , with @ minutes reperfusion intervals .


Biopsies were obtained from the right atrial appendage before and after aortic cross-clamping .


Mitochondrial respiration was measured in situ and miR assessed by commercial miR array and quantitative reverse transcription polymerase chain reaction .


Postoperative atrial fibrillation occurrence was monitored by biotelemetry .


Maximal mitochondrial respiration was preserved throughout surgery after RIPC but significantly reduced ( -@ % ; P < @ ) after aortic cross-clamping in control .


Incidence of postoperative atrial fibrillation was lower after RIPC versus control ( @ % versus @ % ; P < @ ) .


Myocardial expression of miR-@a and miR-@b increased after aortic cross-clamping in both RIPC and control , whereas miR-@ was upregulated in control only .


MiR-@-@p expression was higher in RIPC versus control after aortic cross-clamping .


RIPC preserves mitochondrial respiration and prevents upregulation of miR-@ in the right atrium during coronary artery bypass graft .


Providing different programs of occupational health services in the same company is difficult .


We report the results of a parallel randomized trial for the employees of our company for visceral fat measurements and the effect of a weight loss support web system .


@ healthy employees with BMI over @ who volunteered to participate in this study .


In a parallel randomized study , we divided them into @ groups ( A , health guidance by occupational health staff with visceral fat measurements and a weight loss support web system ; B , health guidance by occupational health staff with a weight loss support web system ; C , without health guidance ( control ) ) by date of birth .


To assess the effects of guidance and support , we compared each group 's waist circumference ( WC ) , weight , and BMI , before and after the guidance .


We also conducted questionnaire surveys of eating behavior and life activities before and after the guidance to estimate the relationship between the intervention method used for each group and their behavioral modification .


@ employees ( @ % ) finished this program .


Within @ months , reduction in the outcome measures was largest in group A , and showed significant differences from the other two groups .


For many employees in group A , eating behavior factors improved markedly ; however , in the control group , there were no changes in eating behavior or daily living activities .


A parallel randomized trial involving the employees of our company was performed and we scientifically verified the effects of an occupational health programs .


Objective study of occupational health activities and measures were enabled by devising methods and procedures , e.g. , applying the waiting-list method for the control group .


This approach will lead to appropriate selection and precise implementation of evidence-based measures in occupational health in the future .


This paper reports long-term results of RTOG @ , to determine whether the addition of erythropoietin ( EPO ) would improve the outcomes of radiation therapy ( RT ) in mildly to moderately anemic patients with head and neck squamous cell carcinoma ( HNSCCa ) .


The trial included HNSCCa patients treated with definitive RT. .


Patients with stage III or IV disease received concomitant chemoradiation therapy or accelerated fractionation .


Pretreatment hemoglobin levels were required to be between @ and @ g/dL ( @ g/dL for females ) .


EPO , @,@ U , was administered weekly starting @ to @days before RT was initiated in the RT+EPO arm .


A total of @ of @ enrolled patients were evaluable .


The baseline median hemoglobin level was @ g/dL .


In the RT+EPO arm , the mean hemoglobin level at @weeks increased by @ g/dL , whereas it decreased by @ g/dL in the RT arm .


With a median follow-up of @ years ( range : @-@ @ years ) for surviving patients and @ years for all patients ( range : @-@ @ years ) , the @-year estimate of local-regional failure was @ % versus @ % ( P = @ ) , local-regional progression-free survival was @ % versus @ % ( P = @ ) , and overall survival was @ % versus @ % ( P = @ ) for the RT+EPO and RT arms , respectively .


Late toxicity was not different between the @ arms .


This long-term analysis confirmed that despite the ability of EPO to raise hemoglobin levels in anemic patients with HNSCCa , it did not improve outcomes when added to RT. .


The possibility of a detrimental effect of EPO could not be ruled out .


To define protein molecular characteristics of tumor cells prior to , and immediately following , preoperative human epidermal growth factor receptor @ ( HER@ ) - targeted therapy that correlate with pathologic complete response ( pCR ) or non response ( no pCR ) to preoperative HER@-directed therapy and chemotherapy .


This open-label , phase II study randomized patients with HER@-positive stage II or III invasive breast cancer to trastuzumab , lapatinib , or both , @ weeks prior to and during chemotherapy with FEC@ for @ courses ; then paclitaxel @ mg/m@ weekly for @ courses , then surgery .


Core needle biopsies were collected at baseline and after @ weeks of anti-HER@ therapy prior to chemotherapy .


Data were correlated with pCR , defined as absence of invasive tumor in breast and lymph nodes .


Of @ enrolled patients , the analysis population included those who had surgery and received @ % chemotherapy ( @ % -LSB- n = @ -RSB- ) .


pCRs by arm are : trastuzumab ( n = @ ) , @ % -LSB- n = @ -RSB- ; lapatinib ( n = @ ) , @ % -LSB- n = @ -RSB- ; trastuzumab plus lapatinib ( n = @ ) , @ % -LSB- n = @ -RSB- ) .


Paired biopsy specimens were available for @ patients ( @ % ) .


Tumor cells of patients with pCR in the trastuzumab or lapatinib treatment arms showed nonphosphorylated FOXO , phosphorylated Stat@ , and sparse signal-transduction protein network crosstalk representing different patterns of connections with PI@K and autophagy proteins compared with no pCR .


In this exploratory study , pCR with preoperative anti-HER@ therapy and chemotherapy correlated with the levels and phosphorylation status of specific baseline signal pathway proteins in tumor cells .


These data may provide candidate biomarkers to stratify initial treatment and potential combination therapies for future study .


Tissue preservation technology introduced here makes this procedure widely feasible .


To investigate the feasibility and effectiveness of conducting two positive psychology interventions to improve mood and self-concept with survivors of traumatic brain injury ( TBI ) , within a neuro-rehabilitation hospital .


Ten patients with brain injury were randomly allocated to an intervention and control group .


The efficacy of the first intervention , ` three positive things in life ' was measured via Seligman 's Authentic Happiness Index ( AHI ) , at base-line , directly following the intervention and at the end of the @-week group programme .


The second intervention , the ` Value in Action ( VIA ) signature strengths intervention ' was measured by the Head Injury Semantic Differential Scale ( HISDS ) at baseline and at the end of the group .


Compared to baseline and control group scores , the AHI index showed an increase in the intervention group 's happiness following the intervention and at the end of the @-week programme , albeit the latter increase was non-significant .


The HISDS showed non-significant improvement in self-concept and reduction in polarization of the self in the present , future and past in the second intervention .


Anecdotal evidence revealed a clear improved mood following the interventions .


This study shows promising results for the effectiveness of Positive Psychology interventions and methods to improve feasibility when applying this treatment within a hospital setting .


The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease ( COPD ) is unclear .


The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists ( LAMA ) , when combined with an inhaled corticosteroid ( ICS ) and a long-acting @ agonist ( LABA ) .


This randomised , blinded , placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium ( GLY ) @g , once-daily tiotropium ( TIO ) @g or placebo ( PLA ) , when combined with salmeterol/fluticasone propionate ( SAL/FP ) @/@g twice daily .


The primary objective was to determine the non-inferiority of GLY+SAL / FP versus TIO+SAL / FP on trough FEV@ after @weeks .


An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone .


@ patients ( mean FEV@ @ % predicted ) were randomised ; @ % completed the trial .


At week @ , GLY+SAL / FP demonstrated non-inferiority to TIO+SAL / FP for trough FEV@ : least square mean treatment difference ( LSMdiff ) -@ mL ( SE @ ) with a lower limit for non-inferiority of -@ mL .


There was significant increase in week @ trough FEV@ with GLY+SAL / FP versus PLA+SAL / FP ( LSMdiff @mL , p < @ ) .


At @weeks , GLY+SAL / FP produced significant improvement in St George 's Respiratory Questionnaire total score versus PLA+SAL / FP ( LSMdiff -@ , p = @ ) .


GLY+SAL / FP demonstrated significant rescue medication reduction versus PLA+SAL / FP ( LSMdiff -@ puffs/day , p < @ ) .


Serious adverse events were similar for GLY+SAL / FP , TIO+SAL / FP and PLA+SAL / FP with an incidence of @ % , @ % and @ % , respectively .


GLY+SAL / FP showed comparable improvements in lung function , health status and rescue medication to TIO+SAL / FP .


Importantly , addition of GLY to SAL/FP demonstrated significant improvements in lung function , health status and rescue medication compared to SAL/FP .


There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors .


Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable ( F/V ) intake and decreasing fat intake among Hispanic breast cancer survivors .


Participants were randomized to Intervention and Control groups .


Diet recalls , detailed interviews , fasting blood , and anthropometric measures were collected at baseline , @ , @ , and @ months .


Hispanic women ( n = @ ) with stage @ to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April @ and March @ .


The Intervention group ( n = @ ) participated in Cocinar Para Su Salud !


, a culturally based nine-session ( @ hours over @ weeks ) intervention including nutrition education , cooking classes , and food-shopping field trips .


The Control group ( n = @ ) received written dietary recommendations for breast cancer survivors .


Change at @ months in daily F/V servings and percent calories from total fat were the main outcome measures .


Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to @ and @ months .


Baseline characteristics were the following : mean age @ years ( standard deviation @ years ) , mean time since diagnosis @ years ( standard deviation @ years ) , mean body mass index ( calculated as kg/m ) @ ( standard deviation @ ) , @ % with annual household income $ @,@ , mean daily servings of all F/V was @ ( targeted F/V @ servings excluding legumes/juices/starchy vegetables/fried foods ) , and @ % of daily calories from fat .


More than @ % in the Intervention group attended seven or more of nine classes , with overall study retention of @ % retention at @ months .


At month @ , the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline ( all F/V : +@ vs -@ ; P = @ ; targeted F/V : +@ vs +@ ; P = @ ) and a nonsignificant decrease in percent calories from fat ( -@ % vs -@ % ; P = @ ) and weight ( -@ kg vs +@ kg ; P = @ ) .


Cocinar Para Su Salud !


was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors .


Copeptin , a quantitative marker of endogenous stress , seems to provide incremental value in addition to cardiac troponin in the early rule-out of acute myocardial infarction ( AMI ) .


Prevalence , characteristics and outcome of acute chest pain patients with causes other than AMI and elevated copeptin are poorly understood .


A total of @ consecutive patients with non-cardiac chest pain were selected from a prospective multicentre study of acute chest pain patients presenting to the emergency department .


Levels of copeptin were determined in a blinded fashion and considered elevated if above @pmol/L ( the @,@ th centile of healthy individuals ) .


The final diagnosis was adjudicated by two independent cardiologists .


Median duration of follow-up was @days .


Elevated copeptin levels were seen in @ patients ( @ % ) .


In comparison to patients with normal copeptin levels , patients with elevated levels were older , had more pre-existing cardiac and non-cardiac disorders , more silent cardiomyocyte injury and increased haemodynamic stress as quantified by levels of high-sensitivity cardiac troponin T ( @ ng/L ( @-@ @ ) vs @ ng/L ( @-@ @ ) ) and B-type natriuretic peptide ( @ng/L ( @-@ ) vs @ng/L ( @-@ ) ) ( both p < @ ) , more electrocardiographic abnormalities , more often an adjudicated diagnosis of gastroesophageal reflux or bronchitis/pneumonia and higher @-year mortality ( HR @ , @ % CI @ to @ ) .


The increased mortality rate seemed to be largely explained by age and comorbidities .


Elevated levels of copeptin are present in about one in five patients with non-cardiac chest pain and are associated with aging , cardiac and non-cardiac comorbidities as well as mortality .


This study investigated the efficacy of low-level laser therapy ( LLLT ) for the management of temporomandibular joint ( TMJ ) osteoarthritis .


In a double-blind clinical trial , @ patients with TMJ osteoarthritis were randomly divided into laser and placebo groups .


The patients in the laser group received irradiation from an @ nm low-level laser ( Peak power @ W , average power @ mW , @ Hz , @ micro s pulse width , @ seconds , @ J , @ J/cm ( @ ) per point ) , which was applied on four points around the TMJs and on painful muscles three times a week for @ weeks .


In the placebo group , the treatment was the same as that in the laser group , but with laser simulation .


The patients were evaluated before laser therapy ( T@ ) , after @ ( T@ ) and @ ( T@ ) laser applications and @ month after the last application ( T@ ) , and the amount of mouth opening and the pain intensity were recorded .


No significant differences were found in mouth opening either between the study groups or between the different evaluation times in each group ( P > @ ) .


There was no significant difference in pain symptoms of the masticatory muscles and TMJ between the laser and the placebo groups ( P > @ ) , but some significant within-group improvements were present for Visual Analogue Scale ( VAS ) scores of the body of the masseter and TMJ in both groups .


LLLT using the present laser parameters was no more effective than the placebo treatment for reducing pain and improving mouth opening in patients with TMJ osteoarthritis .


Hypoxemia secondary to reduced barometric pressure is a complication of ascent to altitude .


We designed a study to compare the reversal of hypobaric hypoxemia at @,@ ft with continuous flow oxygen from a cylinder and pulsed dose oxygen from a portable concentrator .


There were @ healthy volunteers who were randomized to one of three study groups , placed in an altitude chamber , and ascended to @,@ ft. There were @ subjects in each study group .


Subjects breathed room air for @ min to induce hypoxemia .


Oxygen was then delivered via a nasal cannula from a cylinder at @ , @ , or @ lpm of continuous flow for @ min .


The subjects again breathed room air at altitude for @ min and were then placed on pulsed dose oxygen and titrated to obtain the continuous flow Spo@ equivalent .


Spo@ , Etco@ , RR , HR , Hgb , and tissue oxygenation ( Sto@ ) were continuously recorded .


The @-lpm group 's Spo@ range was @-@ % .


The @-lpm group 's Spo@ range was @-@ % , and the @-lpm group 's Spo@ range was @-@ % .


The @-lpm and @-lpm flows were able to correct hypoxemia in every subject .


The mean pulsed dose required to achieve an equivalent Spo@ ranged from @ ml @ ml in the @-lpm arm , and @ ml @ in the @-lpm arm .


Portable oxygen concentrators using pulsed dose technology corrected hypoxemia in every subject .


Oxygen concentrators may be an alternative to liquid oxygen or cylinders for use during aeromedical evacuation .


Breast cancer is the most common cancer and the leading cause of death among Latinas in the United States .


The Multi-level Intervention to Increase Participation in Mammography Screening study ( Fortaleza Latina ! )


is a partnership among research institutions , a Latino-serving community-based primary care clinic organization , and a cancer treatment center .


The study will assess the efficacy of a clinic - and patient-level program to increase breast cancer screening among Latinas in Western Washington .


The intervention is a multi-level breast cancer screening program in four participating primary care clinics .


The study is a parallel randomized controlled trial of @ Latino women aged @-@ who are non-compliant with breast cancer screening guidelines .


Participants will be randomized within clinic using block randomization to : ( @ ) a control arm ( usual care ) ; and ( @ ) a theory-based counseling program consisting of a ` promotora ' or community health worker-led home-based intervention to encourage breast cancer screening .


At the clinic-level , two clinics will offer additional mammography services provided by a mobile mammography unit operated by the Seattle Cancer Care Alliance .


The primary endpoint is the rate of mammography uptake over the @-year follow-up period .


This multi-level intervention aims to raise rates of participation in breast cancer screening among Latino women .


If effective , the program may improve rates of early detection of breast cancer in Latino women .


Clinicaltrials.gov


To determine the perceived risk of type @ diabetes in a sample of healthy middle-aged adults and examine the association between perceived risk and modelled risk , clinical risk factors , and psychological factors theorised to be antecedents of behaviour change .


An exploratory , cross-sectional analysis of perceived risk of type @ diabetes ( framed according to time and in comparison with peers ) was conducted using baseline data collected from @ participants of the Diabetes Risk Communication Trial ( Cambridgeshire , UK ) .


Type @ diabetes risk factors were measured during a health assessment and the Framingham Offspring Diabetes Risk Score was used to model risk .


Questionnaires assessed psychological factors including anxiety , diabetes-related worry , behavioural intentions , and other theory-based antecedents of behaviour change .


Multivariable regression analyses were used to examine associations between perceived risk and potential correlates .


Participants with a high perceived risk were at higher risk according to the Framingham Offspring Diabetes Risk Score ( p < @ ) .


Higher perceived risk was observed in those with a higher body fat percentage , lower self-rated health , higher diabetes-related worry , and lower self-efficacy for adhering to governmental recommendations for physical activity ( all p < @ ) .


The framing of perceived risk according to time and in comparison with peers did not influence these results .


High perceived risk of type @ diabetes is associated with higher risk of developing the disease , and a decreased likelihood of engagement in risk-reducing health behaviours .


Risk communication interventions should target high-risk individuals with messages about the effectiveness of prevention strategies .


Although multivitamins are widely used , there are limited prospective studies investigating their association with both long - and short-term risk of cardiovascular disease ( CVD ) .


The objective was to investigate how multivitamin use is associated with the long - and short-term risk of CVD .


A prospective cohort study was conducted of @,@ women from the Women 's Health Study aged @ y and free of CVD and cancer at baseline who were followed for an average of @ y.


At baseline , women self-reported a wide range of lifestyle , clinical , and dietary factors .


Women were categorized into @ ) no current use and @ ) current use of multivitamins .


Duration and updated measures over the course of the follow-up to address short-term effects were also considered .


Women were followed for major CVD events , including myocardial infarction ( MI ) , stroke , and CVD death .


During the follow-up , @ incident cases of CVD -LSB- defined as myocardial infarction ( MI ) , stroke , and CVD death -RSB- occurred .


In multivariable analyses , multivitamin use compared with no use was not associated with major CVD events ( HR : @ ; @ % CI : @ , @ ) , MI ( HR : @ ; @ % CI : @ , @ ) , stroke ( HR : @ ; @ % CI : @ , @ ) , or CVD death ( HR : @ ; @ % CI : @ , @ ) .


A nonsignificant inverse association was observed between baseline multivitamin use and major CVD events among women aged @ y ( P-interaction = @ ) and those consuming < @ servings/d of fruit and vegetables ( P-interaction = @ ) .


When updating information on multivitamin use during the course of follow-up , no associations were observed for major CVD events ( HR : @ ; @ % CI : @ , @ ) , MI ( HR : @ ; @ % CI : @ , @ ) , stroke ( HR : @ ; @ % CI : @ , @ ) , and CVD death ( HR : @ ; @ % CI : @ , @ ) .


In this study of middle-aged and elderly women , neither baseline nor time-varying multivitamin use was associated with the long-term risk of major CVD events , MI , stroke , cardiac revascularizations , or CVD death .


Additional studies are needed to clarify the role of multivitamins on CVD .


To compare the immediate effects of electroacupuncture and manual acupuncture on pain , mobility and muscle strength in patients with knee osteoarthritis .


Sixty patients with knee osteoarthritis , with a pain intensity of @ on the pain Numerical Rating Scale , were included .


The patients were randomised into two groups : manual acupuncture and electroacupuncture .


Pain intensity , degree of dysfunction ( Timed Up and Go ( TUG ) test ) , maximal voluntary isometric contraction and pressure pain threshold were assessed before and after a single session of manual acupuncture or electroacupuncture treatments .


Both groups showed a significant reduction in pain intensity ( p < @ ) and time to run the TUG test after the acupuncture treatment ( p = @ for the manual acupuncture group and p = @ for the electroacupuncture group ) .


There were no differences between the groups regarding pain intensity ( p = @ ) , TUG test ( p = @ ) , maximum voluntary isometric contraction ( p = @ ) or pressure pain threshold ( p = @ ) .


This study found no difference between the immediate effects of a single session of manual acupuncture and electroacupuncture on pain , muscle strength and mobility in patients with knee osteoarthritis .


The duration between first symptom and a cancer diagnosis is important because , if shortened , may lead to earlier stage diagnosis and improved cancer outcomes .


We have previously developed a tool to measure this duration in newly-diagnosed patients .


In this two-phase study , we aimed further improve our tool and to conduct a trial comparing levels of anxiety between two modes of delivery : self-completed versus researcher-administered .


In phase @ , ten patients completed the modified tool and participated in cognitive debrief interviews .


In phase @ , we undertook a Randomised Controlled Trial ( RCT ) of the revised tool ( Cancer Symptom Interval Measure ( C-SIM ) ) in three hospitals for @ different cancers .


Respondents were invited to provide either exact or estimated dates of first noticing symptoms and presenting them to primary care .


The primary outcome was anxiety related to delivery mode , with completeness of recording as a secondary outcome .


Dates from a subset of patients were compared with GP records .


After analysis of phase @ interviews , the wording and format were improved .


In phase @ , @ patients were randomised ( @ self-complete and @ researcher-complete ) .


Anxiety scores were significantly lower in the researcher-completed group , with a mean rank of @ ; compared with the self-completed group , with a mean rank of @ ( Mann-Whitney U = @ , p = @ ) .


Completeness of data was significantly better in the researcher-completed group , with no statistically significant difference in time taken to complete the tool between the two groups .


When comparing the dates in the patient questionnaires with those in the GP records , there was evidence in the records of a consultation on the same date or within a proscribed time window for @/@ ( @ % ) consultations ; for estimated dates there was evidence for @/@ consultations ( @ % ) .


We have developed and tested a tool for collecting patient-reported data relating to appraisal intervals , help-seeking intervals , and diagnostic intervals in the cancer diagnostic pathway for @ separate cancers , and provided evidence of its acceptability , feasibility and validity .


This is a useful tool to use in descriptive and epidemiological studies of cancer diagnostic journeys , and causes less anxiety if administered by a researcher .


Radiofrequency ablation of atrial fibrillation has been associated with some risk of thromboembolic events .


Previous studies showed that preventive short episodes of forearm ischemia ( remote ischemic preconditioning -LSB- IPC -RSB- ) reduce exercise-induced platelet reactivity .


In this study , we assessed whether remote IPC has any effect on platelet activation induced by radiofrequency ablation of atrial fibrillation .


We randomized @ patients ( age , @ years ; @ male ) undergoing radiofrequency catheter ablation of paroxysmal atrial fibrillation to receive remote IPC or sham intermittent forearm ischemia ( control subjects ) before the procedure .


Blood venous samples were collected before and after remote IPC/sham ischemia , at the end of the ablation procedure , and @ hours later .


Platelet activation and reactivity were assessed by flow cytometry by measuring monocyte-platelet aggregate formation , platelet CD@ in the monocyte-platelet aggregate gate , and platelet CD@ and CD@ in the platelet gate in the absence and presence of ADP stimulation .


At baseline , there were no differences between groups in platelet variables .


Radiofrequency ablation induced platelet activation in both groups , which persisted after @ hours .


However , compared with control subjects , remote IPC patients showed a lower increase in all platelet variables , including monocyte-platelet aggregate formation ( P < @ ) , CD@ in the monocyte-platelet aggregate gate ( P = @ ) , and CD@ ( P < @ ) and CD@ ( P = @ ) in the platelet gate .


Compared with control subjects , remote IPC was also associated with a significantly lower ADP-induced increase in all platelet markers .


Our data show that remote IPC before radiofrequency catheter ablation for paroxysmal atrial fibrillation significantly reduces the increased platelet activation and reactivity associated with the procedure .


To analyse if social capital modifies the effect of educational intervention of home visitors on mobility disability .


Earlier studies have found that educational intervention of home visitors has a positive effect of older peoples ' functional decline , but how social capital might modify this effect is still unknown .


We used the Danish Intervention Study on Preventive Home Visits - a prospective cohort study including @ @-year-olds and @ @-year-olds in @ Danish municipalities - to analyse the modifying effect of different aspects of social capital on the effect of educational intervention of home visitors on functional decline .


The three measures of social capital ( bonding , bridging , and linking ) were measured at contextual level .


Data was analysed with multivariate linear regression model using generalised estimating equations to account for repeated measurements .


We found that @-year-olds living in municipalities with high bonding ( B = @ , p = @ ) and high linking ( B = @ ; p = @ ) had significant better mobility disability in average at @-year follow up if their municipality had received intervention .


With the unique design of the Danish Intervention Study on Preventive Home Visits and with theory-based measures of social capital that distinguish between three aspects of social capital with focus on older people , this study contributes to the literature about the role of social capital for interventions on mobility disability .


To investigate the effect of preoperative psychological intervention on alleviating negative emotions in patients undergoing emergent ocular trauma surgery .


A total of @ patients undergoing emergent ocular trauma surgery were selected using convenience sampling and randomly divided into control ( n = @ ) and experimental ( n = @ ) groups .


Patients in the control group received conventional nursing and their counterparts in the observation group were treated with individualized psychological interventions including psychological support , relaxation training , and humanistic care based on conventional nursing care .


Self-rating anxiety scale ( SAS ) , self-rating depression scale ( SDS ) , and fear visual analog scale ( FVAS ) scores were statistically compared between the two groups .


The scores of SAS , SDS , and FAVS were significantly lower in the experimental group than in the control group ( all P < @ ) .


Comprehensive psychological intervention effectively eliminates negative emotions in patients undergoing emergent ocular trauma surgery and accelerates their physical and mental recovery .


Vascular endothelial growth factor ( VEGF ) - mediated angiogenesis plays an important role in non-small cell lung cancer ( NSCLC ) .


Ramucirumab is a human immunoglobulin G@ monoclonal antibody that inhibits VEGF receptor @ .


This phase @ study investigated ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in advanced/metastatic NSCLC .


Eligible stage IV nonsquamous NSCLC patients with no prior chemotherapy for metastatic disease were randomized @:@ to pemetrexed and carboplatin ( or cisplatin ) or ramucirumab ( @ mg/kg ) plus pemetrexed and carboplatin ( or cisplatin ) once every @ weeks .


Treatment was given for @ to @ cycles , and this was followed by a maintenance phase with pemetrexed or ramucirumab and pemetrexed .


The primary endpoint was progression-free survival ( PFS ) with a sample size of sufficient power to detect an increase from @ to @ months .


From October @ to October @ , @ patients were randomized ( pemetrexed-platinum arm , @ ; ramucirumab-pemetrexed-platinum arm , @ ) , and most baseline characteristics were similar for the @ treatment arms .


The median PFS was @ months for the pemetrexed-platinum arm and @ months for the ramucirumab-pemetrexed-platinum arm ( hazard ratio , @ ; P = @ ) .


The objective response rates were @ % and @ % for the pemetrexed-platinum and ramucirumab-pemetrexed-platinum arms , respectively ( P = @ ) .


The disease control rate was @ % for the pemetrexed-platinum arm and @ % for the ramucirumab-pemetrexed-platinum arm ( P = @ ) .


The grade @ or higher adverse events occurring in @ % or more of patients were thrombocytopenia , neutropenia , fatigue , anemia , nausea , back pain , and hypertension .


The primary endpoint of significant prolongation of PFS was not met ; however , ramucirumab showed evidence of clinical activity in combination with pemetrexed and platinum in nonsquamous NSCLC patients .


The addition of ramucirumab to pemetrexed and platinum did not result in new or unexpected safety findings .


To combine multiple Heidelberg Retina Tomograph ( HRT ) parameters using the Random Forests classifier to diagnose glaucoma , both in highly and physiologically myopic ( highly myopic ) eyes and emmetropic eyes .


Subjects consisted of healthy subjects and age-matched patients with open-angle glaucoma in emmetropic ( -@ to +@ diopters -LSB- D -RSB- , @ and @ subjects , respectively ) and highly myopic eyes ( -@ to -@ D , @ and @ subjects , respectively ) .


First , area under the receiver operating characteristic curve ( AUC ) was derived using @ HRT global and sectorial parameters and the representative HRT raw parameter ( largest AUC ) was identified .


Then , the Random Forests method was carried out using age , refractive error , and @ HRT parameters .


The AUCs were also derived using the following : ( @ ) Frederick S. Mikelberg discriminant function ( FSM ) score , ( @ ) Reinhard O.W. Burk discriminant function ( RB ) score , ( @ ) Moorfields regression analysis ( MRA ) score , and ( @ ) glaucoma probability score ( GPS ) .


In combined emmetropic and highly myopic population , AUC with Random Forests method ( @ ) was significantly larger than AUCs with the representative HRT raw parameter ( vertical cup-to-disc ratio -LSB- global -RSB- , @ ) , FSM ( @ ) , RB ( @ ) , MRA ( @ ) , and GPS ( @ ) ( P < @ ) .


Similarly , AUC with the Random Forests method was significantly ( P < @ ) larger than these other parameters , both in emmetropic and highly myopic groups .


Also , the Random Forests method achieved partial AUCs above @ % / @ % significantly ( P < @ ) larger than any other HRT parameters in all populations .


Evaluating multiple HRT parameters using the Random Forests classifier provided accurate diagnosis of glaucoma , both in emmetropic and highly myopic eyes .


Dengue virus is the most serious mosquito-borne viral threat to public health and no vaccines or antiviral therapies are approved for dengue fever .


The tetravalent DENVax vaccine contains a molecularly characterised live attenuated dengue serotype-@ virus ( DENVax-@ ) and three recombinant vaccine viruses expressing the prM and E structural genes for serotypes @ , @ , and @ in the DENVax-@ genetic backbone .


We aimed to assess the safety and immunogenicity of tetravalent DENVax formulations .


We undertook a randomised , double-blind , phase @ , dose-escalation trial between Oct @ , @ , and Nov @ , @ , in the Rionegro , Antioquia , Colombia .


The first cohort of participants ( aged @-@ years ) were randomly assigned centrally , via block randomisation , to receive a low-dose formulation of DENvax , or placebo , by either subcutaneous or intradermal administration .


After a safety assessment , participants were randomly assigned to receive a high-dose DENVax formulation , or placebo , by subcutaneous or intradermal administration .


Group assignment was not masked from study pharmacists , but allocation was concealed from participants , nurses , and investigators .


Primary endpoints were frequency and severity of injection-site and systemic reactions within @ days of each vaccination .


Secondary endpoints were the immunogenicity of DENVax against all four dengue virus serotypes , and the viraemia due to each of the four vaccine components after immunisation .