Secondary outcomes are postpartum depression , anxiety , and stress symptoms ; self-efficacy ; mastery ; self-esteem ; sleep ; relationship quality ; coping ; resilience ; Apgar score ; gestational age ; birth weight ; maternal-infant attachment ; infant behavior and development ; parenting stress/competence ; and intervention cost-effectiveness , efficiency , feasibility , and acceptability .


Pregnant women are eligible if they : 1 ) are < 28 weeks gestation ; 2 ) speak/read English ; 3 ) are willing to complete email questionnaires ; 4 ) have no , low , or moderate psychosocial risk on screening at recruitment ; and 5 ) are eligible for CBT .


A sample of 816 women will be recruited from large , urban primary care clinics and allocation is by computer-generated randomization .


Women in the intervention group will complete an online psychosocial assessment , and those with mild or moderate depression , anxiety , or stress symptoms then complete six interactive cognitive behavior therapy modules .


All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3 , 6 , and 12 months postpartum .


Clinic-based providers and researchers conducting chart abstraction and analysis are blinded .


Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention .


Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal , infant , and family-based outcomes .


ClinicalTrials.gov Identifier : NCT01901796 .


Low levels of physical activity , musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer .


Intensive medical treatment and a decline in physical activity may also result in reduced motor performance .


Therefore , simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children 's cancer treatment .


The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer .


The research is conducted as a parallel randomized clinical trial with follow-up .


Patients between 3 and 16 years old , diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate .


Based on statistical estimates , the target enrollment is 40 patients .


The intervention includes playing elective active video games and , in addition , education and consultations for the family .


The control group will receive a general recommendation for physical activity for 30 minutes per day .


The main outcomes are the amount of physical activity and sedentary behavior .


Other outcomes include motor performance , fatigue and metabolic risk factors .


The outcomes are examined with questionnaires , diaries , physical examinations and blood tests at baseline and at 2 , 6 , 12 and 30 months after the baseline .


Additionally , the children 's perceptions of the most enjoyable activation methods are explored through an interview at 2 months .


This trial will help to answer the question of whether playing active video games is beneficial for children with cancer .


It will also provide further reasoning for physical activity promotion and training of motor skills during treatment .


ClinicalTrials.gov identifier : NCT01748058 ( October 15 , 2012 ) .


In COPD patients , reversibility is currently evaluated from the changes of forced expiratory volume at 1s ( FEV1 ) and forced vital capacity ( FVC ) .


By lowering peripheral airway smooth muscle tone , bronchodilators should decrease dynamic hyperinflation , gas trapping , and possibly dyspnea at rest .


Hence , we hypothesize that specific airway resistance changes ( sRAW ) should better characterize the acute response to bronchodilators .


On two days , 60 COPD patients underwent dyspnea evaluation ( VAS score ) and pulmonary function testing at baseline and one hour after placebo or 300g indacaterol administration .


Spirographic and sRAW-based criteria identified as responders 24 and 45 patients , respectively .


sRAW correlated with changes of intrathoracic gas volume ( ITGV ) ( r = 0.61 ; p < 0.001 ) , residual volume ( RV ) ( r = 0.60 ; p < 0.001 ) , FVC ( r = 0.44 ; p = 0.001 ) , and VAS ( r = 0.73 ; p < 0.001 ) , while FEV1 correlated only with FVC ( r = 0.34 ; p = 0.008 ) .


Significant differences in terms of ITGV ( p = 0.002 ) , RV ( p = 0.023 ) , and VAS ( p < 0.001 ) occurred only if patients were stratified according to sRAW .


In assessing the acute functional effect of bronchodilators , sRAW-based criterion is preferable to FEV1-FVC-based criteria , being more closely related to bronchodilator-induced improvements of lung mechanics and dyspnea at rest .


In schizophrenia , the severity of negative symptoms is a key predictor of long-term disability .


Deficient signaling through the N-methyl-D-aspartate receptor is hypothesized to underlie many signs and symptoms associated with schizophrenia in particular negative symptoms .


Glycine acts as an N-methyl-D-aspartate receptor coagonist .


Blockade of the glycine transporter type 1 to inhibit glycine reuptake and elevate synaptic glycine concentrations represents an effective strategy to enhance N-methyl-D-aspartate receptor transmission .


To determine the efficacy and safety of bitopertin ( RG1678 ) , a glycine reuptake inhibitor , in patients with schizophrenia and predominant negative symptoms who were stable while taking an antipsychotic treatment .


This randomized , double-blind , placebo-controlled , phase 2 proof-of-concept trial involved 323 patients with schizophrenia and predominant negative symptoms across 66 sites worldwide .


Bitopertin ( 10 , 30 , or 60 mg/d ) or placebo added to standard antipsychotic therapy for a treatment duration of 8 weeks .


Change from baseline in the Positive and Negative Syndrome Scale negative factor score .


In the per-protocol population , 8 weeks of treatment with bitopertin was associated with a significant reduction of negative symptoms in the 10-mg/d ( mean [ SE ] reduction in negative symptoms score , -25 % [ 2 % ] ; P = .049 ) and 30-mg/d ( mean [ SE ] , -25 % [ 2 % ] ; P = .03 ) bitopertin groups , a significantly higher response rate and a trend toward improved functioning in the 10-mg/d group when compared with placebo ( mean [ SE ] , -19 % [ 2 % ] ) .


Results reached trend-level significance in the intent-to-treat population .


Estimates of bitopertin binding to glycine transporter type 1 showed that low to medium levels of occupancy yielded optimal efficacy in patients , consistent with findings in preclinical assays .


Bitopertin-mediated glycine reuptake inhibition may represent a novel treatment option for schizophrenia , with the potential to address negative symptoms .


clinicaltrials.gov Identifier : NCT00616798 .


Polyphenols may lower the risk of cardiovascular disease ( CVD ) and other chronic diseases due to their antioxidant and anti-inflammatory properties , as well as their beneficial effects on blood pressure , lipids and insulin resistance .


However , no previous epidemiological studies have evaluated the relationship between the intake of total polyphenols intake and polyphenol subclasses with overall mortality .


Our aim was to evaluate whether polyphenol intake is associated with all-cause mortality in subjects at high cardiovascular risk .


We used data from the PREDIMED study , a 7,447-participant , parallel-group , randomized , multicenter , controlled five-year feeding trial aimed at assessing the effects of the Mediterranean Diet in primary prevention of cardiovascular disease .


Polyphenol intake was calculated by matching food consumption data from repeated food frequency questionnaires ( FFQ ) with the Phenol-Explorer database on the polyphenol content of each reported food .


Hazard ratios ( HR ) and 95 % confidence intervals ( CI ) between polyphenol intake and mortality were estimated using time-dependent Cox proportional hazard models .


Over an average of 4.8 years of follow-up , we observed 327 deaths .


After multivariate adjustment , we found a 37 % relative reduction in all-cause mortality comparing the highest versus the lowest quintiles of total polyphenol intake ( hazard ratio ( HR ) = 0.63 ; 95 % CI 0.41 to 0.97 ; P for trend = 0.12 ) .


Among the polyphenol subclasses , stilbenes and lignans were significantly associated with reduced all-cause mortality ( HR = 0.48 ; 95 % CI 0.25 to 0.91 ; P for trend = 0.04 and HR = 0.60 ; 95 % CI 0.37 to 0.97 ; P for trend = 0.03 , respectively ) , with no significant associations apparent in the rest ( flavonoids or phenolic acids ) .


Among high-risk subjects , those who reported a high polyphenol intake , especially of stilbenes and lignans , showed a reduced risk of overall mortality compared to those with lower intakes .


These results may be useful to determine optimal polyphenol intake or specific food sources of polyphenols that may reduce the risk of all-cause mortality .


ISRCTN35739639 .


Cardiovascular morbidity and mortality is high in patients with chronic obstructive pulmonary disease ( COPD ) and arterial stiffness is a potentially modifiable risk factor with added predictive value beyond that obtained from traditional risk factors .


Arterial stiffness has been the target of pharmacologic and exercise interventions in patients with COPD , but the effects appear limited to those patients with more significant elevations in arterial stiffness .


We aimed to identify predictors of increased arterial stiffness in a cohort with moderate to severe COPD .


Aortic pulse wave velocity ( aPWV ) was measured in subjects with moderate to severe COPD enrolled in a multicenter randomized controlled trial .


Subjects were categorized into quartiles based on aPWV values and factors affecting high arterial stiffness were assessed .


Multivariate models were created to identify independent predictors of high aPWV , and cardiovascular disease ( CVD ) .


153 patients were included .


Mean age was 63.2 ( SD 8.2 ) years and mean FEV1 was 55.4 ( SD 15.2 ) % predicted .


Compared to the quartile with the lowest aPWV , subjects in the highest quartile were older , had higher systolic blood pressure ( SBP ) , were more likely to be current smokers , and had greater burden of thoracic aortic calcification .


On multivariate analyses , age ( adjusted OR 1.14 , 95 % CI 1.05 to 1.25 , p = 0.003 ) and SBP ( adjusted OR 1.06 , 95 % CI 1.02 to 1.09 , p = 0.001 ) were independent predictors of elevated aPWV .


Body mass index , therapy with cholesterol lowering medications and coronary calcification were independent predictors of CVD .


Elevated arterial stiffness in patients with COPD can be predicted using age , blood pressure and thoracic aortic calcification .


This will help identify subjects for enrollment in clinical trials using aPWV for assessing the impact of COPD therapies on CV outcomes .


To evaluate the non-inferiority of a lower therapeutic dose ( 300,000 IU ) in comparison to standard dose ( 600,000 ) IU of Vitamin D for increasing serum 25 ( OH ) D levels and achieving radiological recovery in nutritional rickets .


Randomized , open-labeled , controlled trial .


Tertiary care hospital .


76 children ( median age 12 mo ) with clinical and radiologically confirmed rickets .


Oral vitamin D3 as 300,000 IU ( Group 1 ; n = 38 ) or 600,000 IU ( Group 2 ; n = 38 ) in a single day .


Primary : Serum 25 ( OH ) D , 12 weeks after administration of vitamin D3 ; Secondary : Radiological healing and serum parathormone at 12 weeks ; and clinical and biochemical adverse effects .


Serum 25 ( OH ) D levels [ geometric mean ( 95 % CI ) ] increased significantly from baseline to 12 weeks after therapy in both the groups [ Group 1 : 7.58 ( 5.5010.44 ) to 16.06 ( 12.71 20.29 ) ng/mL , P < 0.001 ] ; Group 2 : 6.57 ( 4.669.25 ) to 17.60 ( 13.7122.60 , P < 0.001 ] .


The adjusted ratio of geometric mean serum 25 ( OH ) D levels at 12 weeks between the groups ( taking baseline value as co-variate ) was 0.91 ( 95 % CI : 0.651.29 ) .


Radiological healing occurred in all children by 12 weeks .


Both groups demonstrated significant ( P < 0.05 ) and comparable fall in the serum parathormone and alkaline phosphatase levels at 12 weeks .


Relative change [ ratio of geometric mean ( 95 % CI ) ] in serum PTH and alkaline phosphatase , 12 weeks after therapy , were 0.98 ( 0.71.47 ) and 0.92 ( 0.721.19 ) , respectively .


The serum 25 ( OH ) D levels were deficient ( < 20 ng/mL ) in 63 % ( 38/60 ) children after 12 weeks of intervention [ Group 1 : 20/32 ( 62.5 % ) ; Group 2 : 18/28 ( 64.3 % ) ] .


No major clinical adverse effects were noticed in any of the children .


Hypercalcemia was documented in 2 children at 4 weeks ( 1 in each Group ) and 3 children at 12 weeks ( 1 in Group 1 and 2 in Group 2 ) .


None of the participants had hypercalciuria or hypervitaminosis D.


A dose of 300,000 IU of vitamin D3 is comparable to 600,000 IU , administered orally , over a single day , for treating rickets in under-five children although there is an unacceptably high risk of hypercalcemia in both groups .


None of the regime is effective in normalization of vitamin D status in majority of patients , 3 months after administering the therapeutic dose .


The aim of this study was to identify serum markers that are modulated by an investigational anti-IFN - mAb , sifalimumab , in adult DM or PM patients .


In a phase 1b clinical trial , sera were collected from a total of 48 DM or PM adult patients receiving either placebo for 3 months or sifalimumab for 6 months .


Samples were tested for 128 selected proteins using a multiplex luminex immunoassay .


Muscle biopsies from selected patients were stained for T cell infiltration using an anti-CD3 antibody .


A robust overexpression of multiple serum proteins in DM or PM patients was observed , particularly in patients with an elevated baseline type I IFN gene signature in the blood or muscle .


Neutralization of the type I IFN gene signature by sifalimumab resulted in coordinated suppression of T cell-related proteins such as soluble IL-2RA , TNF receptor 2 ( TNFR2 ) and IL-18 .


Muscle biopsies from two patients with the highest serum protein suppression were selected and found to have a pronounced reduction of muscle T cell infiltration .


Down-regulation of IL-2RA correlated with favourable manual muscle test 8 ( MMT-8 ) alterations in sifalimumab-dosed patients .


A reduced level of multiple T cell-associated proteins after sifalimumab but not placebo administration suggests a suppressive effect of blocking type I IFN signalling on T cell activation and chemoattraction that may lead to a reduction of T cell infiltration in the muscle of myositis patients .


Further , soluble IL-2RA changes from baseline may serve as a responsive and/or predictive marker for type I IFN-targeted therapy in adult DM or PM patients .


The present study aims to assess the efficacy of a structured psychoeducational group intervention for adolescents with early-onset psychosis and their families .


The intervention was implemented in parallel in 2 separate groups by focusing specifically on problem-solving strategies and structured psychosis-related information to manage daily life difficulties associated with the disease , to mitigate crises , and to prevent relapses .


We performed a 9-month , randomized , rater-blinded clinical trial involving 55 adolescent patients with early-onset psychosis and either or both of their parents .


A psychoeducational problem-solving group intervention ( n = 27 ) was compared with a nonstructured group intervention ( n = 28 ) .


The primary outcomes were number of hospitalizations , days of hospitalization , and visits to the emergency department .


The secondary outcome measures were clinical variables and family environment .


Assessments were performed before and after the intervention .


At the end of the group intervention , 15 % of patients in the psychoeducational group and 39 % patients in the nonstructured group had visited the emergency department ( = 3.62 , df = 1 , p = .039 ) .


The improvement in negative symptoms was more pronounced in the psychoeducational group ( 12.84 [ 7.87 ] ) than in the nonstructured group ( 15.81 [ 6.37 ] ) ( p = .039 ) .


A parallel psychoeducational group intervention providing written instructions in a structured manner could help adolescents with early-onset psychosis and their parents to manage crises by implementing problem-solving strategies within the family , thus reducing the number of visits to the emergency department .


Negative symptoms improved in adolescents in the psychoeducational group .


The AVERROES double-blinded , randomized trial demonstrated that apixaban reduces the risk of stroke or systemic embolism ( SSE ) by 55 % compared with aspirin without an increase in major bleeding in patients with atrial fibrillation either who previously tried but failed vitamin K antagonists ( VKA ) therapy or who were expected to be unsuitable for VKA therapy .


In this pre-specified analysis , we explored the consistency of the results in the subgroup of patients who tried but failed VKA therapy .


Of 5599 patients , 2216 ( 40 % ) had previously failed VKA treatment [ main reasons : poor international normalized ratio ( INR ) control 42 % , refusal 37 % , bleeding on VKA 8 % ] .


Compared with those expected to be unsuitable for VKA therapy , those who had previously failed were older , more often male , had higher body mass index , more likely to have moderate renal impairment and a history of stroke and less likely to have heart failure or to be medically undertreated .


The effects of apixaban compared with aspirin were consistent in those who previously failed and those who were expected to be unsuitable , for both SSE ( P interaction 0.13 ) and major bleeding ( P interaction 0.74 ) and were also consistent among different subgroups of patients who had previously failed VKA therapy defined by reasons for unsuitability , age , sex , renal function , CHADS2 score , aspirin dose , duration , indication , and quality of INR control of prior VKA use .


The efficacy and safety of apixaban compared with aspirin is consistent in subgroups of patients who have previously attempted but failed VKA therapy , irrespective of the reason for discontinuation .


Evidence suggests that intestinal microbiota play an important role in the pathogenesis of atopic dermatitis ( AD ) through induction of immunosuppression and immune tolerance ; however , the exact underlying mechanism is unclear .


Few studies to date have examined the effects of probiotics on adult-type AD .


To examine the effects of the probiotic Bifidobacterium animalis subsp lactis LKM512 on adult-type AD and the expression of metabolites that are known to be influenced by gut microbiota in fecal samples .


Forty-four patients were randomly assigned to receive LKM512 or a placebo and underwent medical examinations .


Fecal microbiota were analyzed with real-time polymerase chain reaction .


Metabolomic analysis was conducted to search for antipruritic metabolites produced by intestinal bacteria using feces derived from 3 patients whose itch scores had improved using capillary electrophoresis with time-of-flight mass spectrometry .


Antipruritic effects of kynurenic acid were observed using AD-induced NC/Nga mice .


LKM512 administration alleviated itch in AD patients compared with controls and improved the dermatology-specific quality-of-life scores when compared with the controls .


Administration of LKM512 also increased the expression of the antipruritic and antinociceptive metabolite kynurenic acid ( KYNA ) in patients whose itch score had improved after LKM512 treatment .


In mouse experiments , scratching behavior counts tended to be decreased by KYNA injection when compared with no treatment .


LKM512 administration may exert antipruritic effects by increasing KYNA production .


LKM512 could therefore be a potentially effective therapeutic candidate for the reduction of pruritus .


umin.ac.jp / ctr Identifier : UMIN000005695 .


It is common knowledge that an increase of intra-abdomninal pressure ( lAP ) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region , which may contribute to the development of more high spinal block .


There is currently no research devoted to studying the impact of intra-abdominal pressure in pregnancy on the development of high spinal blockade .


To investigate effects of intra-abdominal pressure in pregnancy on the development of spinal blockade and incidence of hypotension during cesarean section .


170 pregnant women with gestational age 38-40 weeks were included in the randomized , blinded , controlled study .


All the women received elective cesarean section under spinal anesthesia ( SA ) .


Pregnant women w | , ere divided into two groups of 85 females each .


In the first group , the anesthesiologist did not know the value of lAP and used the dose of local anesthetic focusing on height , weight , and according to his own experience .


In the second group , an anesthesiologist corrected dose of local anesthetic depending on the lAP and also considered the height and weight of a woman .


In 9.2 % of women , lAP was less than 11 mmHg ( physiologically normal ) , in 49 % -- from 12 to 15 mmHg ( degree I of intra-abdominal hypertension ( IAH ) ) , in 40.3 % -- from 16 to 20 mmHg ( degree II of IAH ) , in 1.5 % -- from 21 to 25 mmHg ( degree III of IAH ) .


In the first group , the incidence of high spinal block ( above Th4 ) and incidence of arterial hypotension ( systolic blood pressure under 90 mm.Hg ) was two times higher than in the second group ( p < 0.01 ) .


Intra-abdominal hypertension in pregnant women contributed to the development of high spinal block and hypotension .


To prevent these complications , we recommend decreasing the dose of local anesthetic with use of the Scale of the Risk of developing high spinal block in pregnant .


We examine whether the Shifting Boundaries ( SB ) intervention , a primary intervention to prevent youth dating violence and sexual harassment ( DV/H ) , is differentially effective for girls compared with boys or for youth with a history of DV/H experiences .


We randomly assigned SB to 30 public middle schools in New York City , enrolling 117 sixth and seventh grade classes to receive a classroom , building , combined , or neither intervention .


The SB classroom intervention included six sessions emphasizing the laws/consequences of DV/H , establishing boundaries and safe relationships .


The SB schoolwide/building intervention included the use of school-based restraining orders , greater faculty/security presence in unsafe `` hot spots '' mapped by students , and posters to increase DV/H awareness and reporting .


Student surveys were implemented at baseline , immediately after intervention , and 6 months after intervention .


At 6 months after intervention , the SB building-level intervention was associated with significant reductions in the frequency of sexual harassment ( SH ) perpetration and victimization ; the prevalence and frequency of sexual dating violence victimization ; and the frequency of total dating violence victimization and perpetration .


We also had one anomalous finding that the interventions were associated with an increase in the prevalence of SH victimization .


These results were consistent for girls and boys , and those with or without a history of DV/H , with the one exception for those exposed to the SB building condition who had earlier reported perpetrating SH had a significantly lower frequency of perpetrating SH at the follow-up than those without such a history .


SB can provide effective universal prevention of middle school DV/H experiences , regardless of students ' prior exposure histories , and for boys and girls .


Edoxaban is an oral , direct , once-daily factor Xa inhibitor .


This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery .


In this multicenter , randomized , open-label , active-comparator , phase 3 trial , 92 patients were randomized 2:1 to receive edoxaban 30mg once daily ( n = 62 ) or enoxaparin sodium ( enoxaparin ) 2000IU ( equivalent to 20mg ) twice daily ( n = 30 ) for 11 to 14days .


The primary endpoints were the incidence of major or clinically relevant non-major ( CRNM ) bleeding and incidence of any bleeding events ( major , CRNM , or minor bleeding ) .


Secondary efficacy endpoints included the incidence of thromboembolic events , venous thromboembolism-related deaths , and all-cause deaths .


Additional adverse events were recorded throughout the study .


In the edoxaban and enoxaparin treatment groups , the incidence of major or CRNM bleeding was 3.4 % and 6.9 % , respectively , while any bleeding event occurred in 25.4 % and 17.2 % of patients , respectively .


The incidence of thromboembolic events was 6.5 % in the edoxaban group and 3.7 % in the enoxaparin group .


All events were asymptomatic deep vein thrombosis .


The incidence of adverse events was 72.9 % and 82.8 % in the edoxaban and enoxaparin groups , respectively .


Compared to subcutaneous enoxaparin 2000IU twice daily , oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery .


NCT01181141 .


The prevalence and significance of low normal and abnormal ankle brachial index ( ABI ) values in a community-dwelling population of sedentary , older individuals is unknown .


We describe the prevalence of categories of definite peripheral artery disease ( PAD ) , borderline ABI , low normal ABI , and no PAD and their association with lower-extremity functional performance in the LIFE Study population .


Participants age 70 to 89 in the LIFE Study underwent baseline measurement of the ABI , 400-m walk , and 4-m walking velocity .


Participants were classified as follows : definite PAD ( ABI < 0.90 ) , borderline PAD ( ABI 0.90 to 0.99 ) , low normal ABI ( ABI 1.00 to 1.09 ) , and no PAD ( ABI 1.10 to 1.40 ) .


Of 1566 participants , 220 ( 14 % ) had definite PAD , 250 ( 16 % ) had borderline PAD , 509 ( 33 % ) had low normal ABI , and 587 ( 37 % ) had no PAD .


Among those with definite PAD , 65 % were asymptomatic .


Adjusting for age , sex , race , body mass index , smoking , and comorbidities , lower ABI was associated with longer mean 400-m walk time : ( definite PAD = 533 seconds ; borderline PAD = 514 seconds ; low normal ABI = 503 seconds ; and no PAD = 498 seconds [ P < 0.001 ] ) .


Among asymptomatic participants with and without PAD , lower ABI values were also associated with longer 400-m walk time ( P < 0.001 ) and slower walking velocity ( P = 0.042 ) .


Among older community-dwelling men and women , 14 % had PAD and 49 % had borderline or low normal ABI values .


Lower ABI values were associated with greater functional impairment , suggesting that lower extremity atherosclerosis may be a common preventable cause of functional limitations in older people .


http://clinicaltrials.gov/ Unique identifier : NCT01072500 .


Magnesium plays an important role in the modulation of vascular tone and endothelial function and can regulate glucose and lipid metabolism .


Patients with hypertension , metabolic syndrome ( MetS ) and diabetes mellitus ( T2DM ) have low body magnesium content ; indeed , magnesium supplementation has been shown to have a positive effect on blood pressure ( BP ) and gluco-metabolic parameters .


The aim of our study was to evaluate the effect of magnesium supplements on hemodynamic and metabolic parameters in healthy men with a positive family history of MetS or T2DM .


In a randomized , double-blind , placebo-controlled 8-week crossover trial with a 4 week wash-out period , oral supplements of 8.1 mmol of magnesium-pidolate or placebo were administered twice a day to 14 healthy normomagnesemic participants , aged 23-33 years .


The primary endpoint was office BP , measured with a semiautomatic oscillometric device .


Secondary endpoints included characteristics of the MetS , namely endothelial function , arterial stiffness and inflammation .


Plasma and urinary magnesium were measured in all participants while free intracellular magnesium was measured only in a subsample .


There was no significant difference in either systolic and diastolic BP in participants post-magnesium supplementation and post-placebo treatment when compared to baseline BP measurements .


Further , the metabolic , inflammatory and hemodynamic parameters did not vary significantly during the study .


Our study showed no beneficial effect of magnesium supplements on BP , vascular function and glycolipid profile in young men with a family history of MetS/T2DM ( trial registration at clinicaltrial.gov ID : NCT01181830 ; 12th of Aug 2010 ) .


To explore the safety and efficacy of high-frequency chest wall oscillation ( HFCWO ) in invasive mechanical ventilation patients with acute exacerbation of chronic obstructive pulmonary disease ( AECOPD ) .


A prospective , randomized , controlled trial was conducted .


Thirty-five AECOPD patients with invasive mechanical ventilation were included in the intensive care unit of West China Hospital of Sichuan University from February 2012 to February 2013 .


The patients were randomly allocated into a HFCWO ( H ) group and a control group using SAS 9.1 software .


The control group received routine therapy , while the H group received HFCWO , along with routine therapy .


Invasive mechanical ventilation time , noninvasive ventilation time , total mechanical ventilation time , ICU stay time , hospital stay time and pH , oxygen index ( OI ) during the first 7 days were collected .


At the same time , heart rate , blood pressure , respiratory rate , SpO2 and peak airway pressure before , during and after HFCWO and ventilation alarm of the H group were collected .


The total mechanical ventilation time of patients in the H group was significantly shorter than that of the control group [ ( 10 6 ) d and ( 15 8 ) d , P < 0.05 ] .


But there were no significant differences between the 2 groups in invasive mechanical ventilation time , noninvasive ventilation time , ICU stay and hospital stay time ( P > 0.05 ) .


There were no significant differences between the 2 groups in pH and oxygen index during the first 7 days ( P > 0.05 ) .


There were no change in heart rate , blood pressure , respiratory rate , SpO2 and peak airway pressure before , during and after HFCWO in the H group ( P > 0.05 ) .


Severe ventilator alarm ( level 3 ) occurred in 3.67 % patients , but there was no significant correlation between ventilation alarm and patient prognosis .


HFCWO is very safe and comfortable in ventilated patients with AECOPD .


It reduces the total mechanical ventilation time , but can not improve the prognosis .


To evaluate , in situ , the penetration of deposits formed within the subsurface of dentin samples treated with desensitizing dentifrices designed to occlude dentin tubules compared to two controls .


Twenty-eight healthy participants wore left and right intraoral appliances , each retaining four human dentin samples , for two periods of 4 days .


Samples were power-brushed , outside the mouth , twice daily with test products ( dentifrices containing 8 % strontium or 8 % arginine ) or control ( 1,450 ppm NaF or water ) and subjected to an agitated grapefruit juice acid challenge on days 3 and 4 .


Eighteen dentin samples were randomly selected from each treatment group and were dry fractured for scanning electron microscopy and energy-dispersive x-ray spectroscopy analysis .


The proportion of cross-sectioned dentin tubules with subsurface occlusion ( occluded to a mean of 5 2 m , range : 1 to 9 m below the surface ) for the 8 % strontium group on days 1 and 2 ( pre-acid ) was 82 % ( SD : 9 % , 95 % confidence interval [ CI ] = 78 % to 86 % ) and on days 3 and 4 ( post-acid ) was 88 % ( SD : 10 % , CI = 83 % to 93 % ) .


For 8 % arginine on days 3 and 4 ( post-acid ) , the proportion was 78 % ( SD : 8 % , CI = 74 % to 82 % ) .


These results were statistically significant compared to those for controls ( P < .01 ) .


The 8 % arginine on days 1 and 2 ( pre-acid ) and water and control paste on all days revealed no subsurface deposit .


Within the limitations of this study , cross-sectional SEM analysis suggested strontium and arginine dentifrices occlude tubules subsurface in dentin compared to negative controls following acid challenge .


The desensitizing dentifrices elicit subsurface changes that may potentiate their effects for the management of dentin hypersensitivity , particularly for patients who consume acidic beverages .


Increased circulating endostatin levels have been demonstrated in progressive cardiovascular ( CV ) and renal disorders .


We investigated the predictive value of endostatin in patients with chronic heart failure ( HF ) and the association between endostatin and renal function .


The interaction between serum endostatin , estimated glomerular filtration rate ( eGFR ) and predefined endpoints , including the primary endpoint ( CV death , nonfatal myocardial infarction , nonfatal stroke ; n = 397 ) , all-cause mortality ( n = 410 ) , CV death ( n = 335 ) or the coronary endpoint ( n = 317 ) , was evaluated in 1,390 patients > 60 years of age with ischemic systolic HF in the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) population , who were randomly assigned to 10 mg rosuvastatin or placebo .


In the population as a whole , endostatin added no predictive information after full multivariable adjustment including eGFR and N-terminal pro-brain natriuretic peptide .


Serum endostatin was strongly correlated with eGFR ( r = 0.59 , p < 0.001 ) .


After full multivariable adjustment , an association between high serum endostatin and increased risk of all-cause mortality and decreased risk of the primary and coronary endpoints was seen in HF patients with impaired and preserved renal function , respectively .


Endostatin added no predictive information regarding the adverse outcome in patients with chronic systolic HF of ischemic etiology .


An increased risk of all-cause mortality was seen in patients with decreased renal function .


The number of preterm birth is increasing worldwide , especially in low income countries .


Malawi has the highest incidence of preterm birth in the world , currently estimated at 18.1 percent .


The aim of this study was to explore the perceived causes of preterm birth , care practices for preterm newborn babies and challenges associated with preterm birth among community members in Mangochi District , southern Malawi .


We conducted 14 focus group discussions with the following groups of participants : mothers ( n = 4 ) , fathers ( n = 6 ) and grandmothers ( n = 4 ) for 110 participants .


We conducted 20 IDIs with mothers to preterm newborns ( n = 10 ) , TBAs ( n = 6 ) and traditional healers ( n = 4 ) .


A discussion guide was used to facilitate the focus group and in-depth interview sessions .


Data collection took place between October 2012 and January 2013 .


We used content analysis to analyze data .


Participants mentioned a number of perceptions of preterm birth and these included young and old maternal age , heredity , sexual impurity and maternal illness during pregnancy .


Provision of warmth was the most commonly reported component of care for preterm newborns .


Participants reported several challenges to caring for preterm newborns such as lack of knowledge on how to provide care , poverty , and the high time burden of care leading to neglect of household , farming and business duties .


Women had the main responsibility for caring for preterm newborns .


In this community , the reported poor care practices for preterm newborns were associated with poverty and lack of knowledge of how to properly care for these babies at home .


Action is needed to address the current care practices for preterm babies among the community members .


Uveal melanoma is characterized by mutations in GNAQ and GNA11 , resulting in mitogen-activated protein kinase pathway activation .


To assess the efficacy of selumetinib , a selective , non-adenosine triphosphate competitive inhibitor of MEK1 and MEK2 , in uveal melanoma .


Randomized , open-label , phase 2 clinical trial comparing selumetinib vs chemotherapy conducted from August 2010 through December 2013 among 120 patients with metastatic uveal melanoma at 15 academic oncology centers in the United States and Canada .


One hundred one patients were randomized in a 1:1 ratio to receive selumetinib , 75 mg orally twice daily on a continual basis ( n = 50 ) , or chemotherapy ( temozolomide , 150 mg/m2 orally daily for 5 of every 28 days , or dacarbazine , 1000 mg/m2 intravenously every 21 days [ investigator choice ] ; n = 51 ) until disease progression , death , intolerable adverse effects , or withdrawal of consent .


After primary outcome analysis , 19 patients were registered and 18 treated with selumetinib without randomization to complete the planned 120-patient enrollment .


Patients in the chemotherapy group could receive selumetinib at the time of radiographic progression .


Progression-free survival , the primary end point , was assessed as of April 22 , 2013 .


Additional end points , including overall survival , response rate , and safety/toxicity , were assessed as of December 31 , 2013 .


Median progression-free survival among patients randomized to chemotherapy was 7 weeks ( 95 % CI , 4.3-8 .4 weeks ; median treatment duration , 8 weeks ; interquartile range [ IQR ] , 4.3-16 weeks ) and among those randomized to selumetinib was 15.9 weeks ( 95 % CI , 8.4-21 .1 weeks ; median treatment duration , 16.1 weeks ; IQR , 8.1-25 .3 weeks ) ( hazard ratio , 0.46 ; 95 % CI , 0.30-0 .71 ; P < .001 ) .


Median overall survival time was 9.1 months ( 95 % CI , 6.1-11 .1 months ) with chemotherapy and 11.8 months ( 95 % CI , 9.8-15 .7 months ) with selumetinib ( hazard ratio , 0.66 ; 95 % CI , 0.41-1 .06 ; P = .09 ) .


No objective responses were observed with chemotherapy .


Forty-nine percent of patients treated with selumetinib achieved tumor regression , with 14 % achieving an objective radiographic response to therapy .


Treatment-related adverse events were observed in 97 % of patients treated with selumetinib , with 37 % requiring at least 1 dose reduction .


In this hypothesis-generating study of patients with advanced uveal melanoma , selumetinib compared with chemotherapy resulted in a modestly improved progression-free survival and response rate ; however , no improvement in overall survival was observed .


Improvement in clinical outcomes was accompanied by a high rate of adverse events .


clinicaltrials.gov Identifier : NCT01143402 .


Patients with severe aortic stenosis ( AS ) who were deemed too high risk or inoperable for conventional aortic valve replacement ( AVR ) in the PARTNER ( Placement of Aortic Transcatheter Valves ) trial were randomized to transcatheter aortic valve replacement ( TAVR ) versus AVR ( PARTNER-A arm ) or standard therapy ( PARTNER-B arm ) .


This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy .


The PARTNER-A arm included 244 transfemoral ( TF ) and 104 transapical ( TA ) TAVR patients , and 351 AVR patients ; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients .


Deaths were categorized as cardiovascular , noncardiovascular , or uncategorizable , and were characterized by multiphase hazard modelling .


In the PARTNER-A arm , the risk of death peaked after randomization in the TA-TAVR and AVR groups , falling to low levels commensurate with the U.S. population within 3 months .


Early risk was less in TF-TAVR patients , resulting in initial superior survival ; between 12 and 18 months , risk increased , such that within 2 years , TF-TAVR and AVR patients had similar survival rates .


Cardiovascular , noncardiovascular , and uncategorizable deaths for TF-TAVR were 37 % , 43 % , and 20 % , respectively , versus 22 % , 41 % , and 37 % , respectively , for TA-TAVR and 33 % , 43 % , and 24 % , respectively , for AVR .


In the PARTNER-B arm , risk with standard therapy was 60 % per year ; TF-TAVR reduced risk to 20 % per year , resulting in 0.5 years of life added within 2.5 years .


In inoperable AS patients , TAVR substantially reduced the risk of cardiovascular death .


In high-risk patients , TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR , although cardiovascular death was higher after TF-TAVR .


Therefore , TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery .


( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .


To evaluate if pulsatile cardiopulmonary bypass ( CPB ) has any protective influence on renal function in elderly patients undergoing aortic valve replacement ( AVR ) .


Forty-six patients ( 75 years old ) with aortic valve stenosis underwent AVR with either pulsatile perfusion ( PP ) or non-pulsatile perfusion ( NP ) during CPB .


Haemodynamic efficacy of the blood pump during either type of perfusion was described in terms of the energy equivalent pressure and the surplus haemodynamic energy .


Urine samples were collected before surgery , at sternum closure , and at 2 and 18 h of intensive care unit stay to detect acute kidney injury markers .


Perioperative urine levels of N-acetyl -- D-glucosaminidase ( NAG ) , kidney injury molecule-1 and neutrophil gelatinase-associated lipocalin ( NGAL ) were assessed together with plasma creatinine , creatinine clearance ( CCr ) and 24-h haemodynamic monitoring .


Normally distributed continuous variables were described as mean standard deviation and non-normally distributed data were presented as the median [ 25th-75th percentiles ] .


PP was characterized by a significantly higher amount of surplus haemodynamic energy transferred to the patients ( P < 0.001 ) , with lower mean systemic vascular resistance during CPB ( P = 0.020 ) and during 18 h postoperatively ( group-P = 0.018 ) .


No difference was found between pre - and postoperative CCr in the PP group ( 71 23 vs 60 35 ml/min , P = 0.27 ) , while its statistically significant perioperative decrement was observed in the NP group ( 67 24 vs 45 15 ml/min , P < 0.001 ) .


The PP group showed significantly lower urinary levels of NAG at 18 h postoperatively ( P = 0.008 ) , and NGAL at sternum closure ( P = 0.010 ) , 2 h ( P < 0.001 ) and 18 h ( P = 0.015 ) postoperatively .


Short-term PP in elderly patients showed higher safety for renal physiology than NP , resulting in better maintenance of glomerular filtration and lower renal tissue injury .


Restricted intakes of saturated and trans-fatty acids is emphasized in heart-healthy diets , and replacement with poly - and monounsaturated fatty acids is encouraged .


To compare the effects of polyunsaturated fatty acid-rich corn oil ( CO ) and monounsaturated fatty acid-rich extra-virgin olive oil ( EVOO ) on plasma lipids in men and women ( N = 54 ) with fasting low-density lipoprotein cholesterol ( LDL-C ) 130mg/dL and < 200mg/dL and triglycerides ( TG ) 350mg/dL .


In a double-blind , randomized , crossover design ( 21-day treatments , 21-day washout between ) , 4 tablespoons/day CO or EVOO were provided in 3 servings study product/day ( muffin , roll , yogurt ) as part of a weight-maintenance diet ( 35 % fat , < 10 % saturated fat , < 300mg cholesterol ) .


Subjects ate breakfast at the clinic every weekday throughout the study .


Lunches , dinners , and snacks ( and breakfasts on weekends ) were provided for consumption away from the clinic .


Baseline mean ( standard error ) lipids in mg/dL were : LDL-C 153.3 ( 3.5 ) , total cholesterol ( total-C ) 225.7 ( 3.9 ) , non-high-density lipoprotein ( non-HDL ) - C 178.3 ( 3.7 ) , HDL-C 47.4 ( 1.7 ) , total-C/HDL-C 5.0 ( 0.2 ) , and TG 124.8 ( 7.2 ) .


CO resulted in significantly larger least-squares mean % changes ( all P < .001 vs EVOO ) from baseline in LDL-C -10.9 vs -3.5 , total-C -8.2 vs -1.8 , non-HDL-C -9.3 vs -1.6 , and total-C/HDL-C -4.4 vs 0.5 .


TG rose a smaller amount with CO , 3.5 vs 13.0 % with EVOO ( P = .007 ) .


HDL-C responses were not significantly different between conditions ( -3.4 vs -1.7 % ) .


Consumption of CO in a weight-maintenance , low saturated fat and cholesterol diet resulted in more favorable changes in LDL-C and other atherogenic lipids vs EVOO .


The aim of the current study was to assess whether a multifaceted intervention could improve mental health literacy , facilitate help seeking and reduce psychological distress and alcohol misuse in students of a multicampus university in Melbourne , Australia .


In this cluster randomized trial , nine university campuses were paired ( some pairs included more than one campus ) , with one of each pair randomly assigned to either the intervention or control condition .


The interventions were designed to be whole-of-campus and to run over 2 academic years with their effectiveness assessed through recruitment of a monitoring sample of students from each campus .


Interventions included emails , posters , campus events , factsheets/booklets and mental health first aid training courses .


Participants had a 20-min telephone interview at baseline and at the end of academic years 1 and 2 .


This assessed mental health literacy , help seeking , psychological distress and alcohol use .


The primary outcomes were depression and anxiety levels and alcohol use and pertained to the individual level .


There were no effects on psychological distress and alcohol use .


Recall of intervention elements was greater in the intervention group at the end of year 2 .


Students in the intervention group were more likely to say they would go to a drug and alcohol centre for alcohol problems at the end of 6 months .


Although education and awareness may play a role in improving mental health literacy , it is likely that , to achieve changes in psychological distress , interventions would need to be more personalized and intensive .


Daclizumab high-yield process ( HYP ) is a humanized monoclonal antibody that binds to CD25 ( alpha subunit of the interleukin-2 receptor ) and modulates interleukin-2 signaling .


Abnormalities in interleukin-2 signaling have been implicated in the pathogenesis of multiple sclerosis and other autoimmune disorders .


We conducted a randomized , double-blind , active-controlled , phase 3 study involving 1841 patients with relapsing-remitting multiple sclerosis to compare daclizumab HYP , administered subcutaneously at a dose of 150 mg every 4 weeks , with interferon beta-1a , administered intramuscularly at a dose of 30 g once weekly , for up to 144 weeks .


The primary end point was the annualized relapse rate .


The annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a ( 0.22 vs. 0.39 ; 45 % lower rate with daclizumab HYP ; P < 0.001 ) .


The number of new or newly enlarged hyperintense lesions on T2-weighted magnetic resonance imaging ( MRI ) over a period of 96 weeks was lower with daclizumab HYP than with interferon beta-1a ( 4.3 vs. 9.4 ; 54 % lower number of lesions with daclizumab HYP ; P < 0.001 ) .


At week 144 , the estimated incidence of disability progression confirmed at 12 weeks was 16 % with daclizumab HYP and 20 % with interferon beta-1a ( P = 0.16 ) .


Serious adverse events , excluding relapse of multiple sclerosis , were reported in 15 % of the patients in the daclizumab HYP group and in 10 % of those in the interferon beta-1a group .


Infections were more common in the daclizumab HYP group than in the interferon beta-1a group ( in 65 % vs. 57 % of the patients , including serious infection in 4 % vs. 2 % ) , as were cutaneous events such as rash or eczema ( in 37 % vs. 19 % , including serious events in 2 % vs. < 1 % ) and elevations in liver aminotransferase levels that were more than 5 times the upper limit of the normal range ( in 6 % vs. 3 % ) .


Among patients with relapsing-remitting multiple sclerosis , daclizumab HYP showed efficacy superior to that of interferon beta-1a with regard to the annualized relapse rate and lesions , as assessed by means of MRI , but was not associated with a significantly lower risk of disability progression confirmed at 12 weeks .


The rates of infection , rash , and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a .


( Funded by Biogen and AbbVie Biotherapeutics ; DECIDE ClinicalTrials.gov number , NCT01064401 . )


Supraglottic airway devices are often used in airway management to facilitate tracheal intubation .


Knowledge of the distance from the grille of the device to the patient 's vocal cords is essential for the safe passage of the tracheal tube below the vocal cords .


To assess the distance from the glottis to the grille of three supraglottic airway devices [ LMA ( LMA Unique ) , Air-Q ( Air-Q Intubating Laryngeal Airway Reusable ) and CobraPLA ( Cobra Perilaryngeal Airway ) ] and their safe usage as intubation conduits .


Randomised controlled trial .


Tertiary , university hospital .


Thirty women undergoing elective gynaecological surgery with planned supraglottic airway management .


In-vivo fibreoptic assessment and in-vitro measurement .


The distance from the grille to the glottis was defined as primary outcome .


The distance from the beginning of the cuff of a tracheal tube passed through the device to the grille was assessed as secondary outcome .


The three devices exhibited significant differences in the meanSD distance from the glottis to the grille ( LMA 4.61.5 cm , Air-Q 5.71.4 cm , CobraPLA 3.41.4 cm ; P = 0.009 ) .


The Air-Q was predicted to allow the safe passage of a tracheal tube into the trachea , whereas the cuff was predicted to rest on the vocal cords in 57 % of the LMA patients and 14 % of the CobraPLA patients .


Using the LMA Unique as a conduit for tracheal intubation may pose a safety risk , whereas the use of the Air-Q would position the tracheal tube at a safe depth in the trachea .


To determine whether short-term intensive group-based therapy combining modified constraint-induced movement therapy and bimanual therapy ( hybrid-CIMT ) is more effective than an equal total dose of distributed individualized occupational therapy ( standard care ) on upper limb motor and individualized outcomes .


Fifty-three children with unilateral cerebral palsy ( 69 % males ; mean age 7y 10mo , SD 2y 4mo ; Manual Ability Classification System level I , n = 24 ; level II , n = 23 ) were randomly allocated , and 44 received either hybrid-CIMT ( n = 25 ) or standard care ( n = 19 ) .


Standard care comprised six weekly occupational therapy sessions and a 12-week home programme .


Outcomes were assessed at baseline , 13weeks , and 26weeks after treatment .


Groups were equivalent at baseline .


Standard care achieved greater gains on satisfaction with occupational performance after intervention ( estimated mean difference -1.2 , 95 % CI -2.2 to -0.1 ; p = 0.04 ) and Assisting Hand Assessment at 26weeks ( estimated mean difference 3.1 , 95 % CI 0.2-6 .0 ; p = 0.04 ) .


Both groups demonstrated significant improvements in dexterity of the impaired upper limb , and bimanual and occupational performance over time .


The differences between groups were not clinically meaningful .


There were no differences between the two models of therapy delivery .


Group-based intensive camps may not be readily available ; however , individualized standard care augmented with a home programme may offer an effective alternative but needs to be provided at a sufficient dose .


A randomized controlled trial with a matched design was conducted during October 2008 and February 2010 , aiming at reducing HIV-related stigma in healthcare settings .


Forty county hospitals in Fujian and Yunnan provinces of China were matched into pairs and randomized to either an intervention condition or a control condition .


Forty-four service providers were randomly selected from each hospital , yielding a sample of 1,760 .


Intervention outcomes were assessed at baseline , 6 and 12months based on venue-based pair comparisons .


We identified and trained 30 popular opinion leaders in each intervention hospital among service providers to disseminate stigma-reduction messages to their peer providers .


Hospital and participant characteristics were comparable between the intervention and control conditions .


Thirteen out of twenty pairs of hospitals showed significant reduction in the stigma outcome measure at the 6-month follow-up assessment .


For most hospitals , the intervention effects were maintained at the 12-month follow-up assessment .


Among the 13 pair of hospitals , which showed intervention effects at 6months , eight were in Fujian and five were in Yunnan .


The non-significant hospitals at 6months had more beds than significant hospitals .


However , the difference did not reach statistical significance .


A matched design and venue-based analysis provide more insight in assessing intervention effects for facility-based intervention trials .


The identification of venue-based or hospital characteristics that are associated with intervention efficacy provides additional implications for the adaptation and implementation of future interventions .


Transcranial direct current stimulation ( tDCS ) of the motor cortex seems to be effective in improving motor performance in patients with chronic stroke , while some recent findings have reported conflicting results for the subacute phase .


We aimed to verify whether upper extremity motor rehabilitation could be enhanced by treatment with tDCS administered before a rehabilitative session .


Hand dexterity and force in 16 individuals with subacute stroke were assessed before ( T0 ) and after anodal stimulation ( T1 ) and after a successive session of motor rehabilitation ( T2 ) in a double-blind , randomized , sham-controlled , crossover trial .


To confirm the value of the device as a specific effector , behavioral tests were also administered .


Anodal and sham stimulation plus rehabilitation significantly improved manual dexterity ( repeated-measure Anova : A-tDCS : p = 0.005 ; S-tDCS : p = 0.042 ) .


Post hoc analysis revealed a significant stimulation effect only for A-tDCS ( p = 0.013 between T0 and T1 ) and not for S-tDCS , whereas the rehabilitation effect ( between T1 and T2 ) was not significant in either group .


Hand force and behavioral features were unchanged .


Anodal brain stimulation improves hand dexterity but does not increase the effectiveness of the rehabilitation directly .


These results suggest the presence of aftereffects , not priming effects , of A-tDCS superimposed onto motor learning phenomena .


The purpose of this study was to evaluate whether use of combined radiofrequency ablation ( RFA ) and percutaneous iodine-125 ( ( 125 ) I ) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma .


136 patients were randomly assigned to undergo HCC treatment with RFA and percutaneous iodine-125 seed implantation ( RFA - ( 125 ) I , n = 68 ) or RFA-only ( n = 68 ) .


A total of 91 patients had hepatitis B viral infection in both groups .


Rates of tumour recurrence and overall survival were evaluated .


The probabilities of recurrence at 1 - , 3 - , and 5-years were 4.5 % , 22.1 % , and 39.8 % in the RFA - ( 125 ) I group ; and 14.8 % , 35.3 % , and 57.4 % in the RFA-only group , respectively .


The recurrence rate in the RFA - ( 125 ) I group was significantly lower than in the RFA-only group ( HR , 0.508 ; 95 % CI , 0.317-0 .815 ; p = 0.004 by log-rank test ) .


Local and intrahepatic recurrence was significantly lower in the RFA - ( 125 ) I group than in the RFA-only group ( 7.3 % vs. 22.0 % , p = 0.012 by log-rank test ; 17.6 % vs. 32.3 % , p = 0.041 by log-rank test ) .


The probabilities of survival at 1 - , 3 - , and 5-years were 100 % , 86.7 % , and 66.1 % in the RFA - ( 125 ) I group and 95.6 % , 75.0 % , and 47.0 % in the RFA-only group , respectively .


The survival rate in the RFA - ( 125 ) I group was significantly better than in the RFA-only group ( HR , 0.502 ; 95 % CI , 0.313-0 .806 ; p = 0.003 by log-rank test ) .


Cox regression model indicated that the treatment group and tumour size were both recurrence-related and overall survival-related prognostic factors .


There were significant differences in overall survival and cumulative recurrence between RFA - ( 125 ) I and RFA-only for patients with small HCCs ( 3 cm ) .


Treatment with RFA - ( 125 ) I facilitated better local and intrahepatic tumour control and long-term survival compared with treatment of RFA alone .


ClinicalTrials.gov Identifier : NCT01717729 .


To determine the elapsed time while receiving aggressive therapy to the first observation of clinically inactive disease ( CID ) , total duration of CID and potential predictors of this response in a cohort of children with recent onset of polyarticular juvenile idiopathic arthritis ( poly-JIA ) .


Eighty-five children were randomized blindly to methotrexate ( MTX ) , etanercept , and rapidly tapered prednisolone ( MEP ) or MTX monotherapy and assessed for CID over 1 year of treatment .


Patients who failed to achieve intermediary endpoints were switched to open-label MEP treatment .


Fifty-eight ( 68.2 % ) of the 85 patients achieved CID at 1 or more visits including 18 who received blinded MEP , 11 while receiving MTX monotherapy , and 29 while receiving open-label MEP .


Patients starting on MEP achieved CID earlier and had more study days in CID compared to those starting MTX , but the differences were not significantly different .


Patients given MEP ( more aggressive therapy ) earlier in the disease course were statistically more likely to have a higher proportion of followup visits in CID than those with longer disease course at baseline .


Those who achieved American College of Rheumatology Pediatric 70 response at 4 months had a significantly greater proportion of followup visits in CID , compared to those who failed to achieve this improvement ( p < 0.0001 ) .


Of the 32 patients who met criteria for CID and then lost CID status , only 3 fulfilled the definition of disease flare .


Shorter disease duration prior to treatment , a robust response at 4 months , and more aggressive therapy result in a higher likelihood and longer duration of CID in patients with poly-JIA .


The original trial from which data for this analysis were obtained is registered on www.clinicaltrials.gov NCT 00443430 .


A high level of parental control of feeding and disturbed energy self-regulation has previously been suggested as a mechanism for the accelerated growth observed in formula-fed compared with breast-fed infants .


This study explored factors associated with parental control of feeding in a population of formula-fed infants with high levels of self-regulation .


We included 141 formula-fed and 72 breast-fed infants from a randomised controlled trial , who were prospectively followed from under 2months of age to 12months of age .


Anthropometry was recorded at baseline , 4 , 6 and 12months of age .


Parental feeding control was assessed using a Child Feeding Questionnaire at 4 and 12months .


The formula-fed groups fully compensated for different energy and protein densities by regulating their volume intakes .


Parents of formula-fed infants had a lower pressure to eat score at 12months than parents of breast-fed infants .


A high parental restrictive score at 12months was associated with weight at 12months and high parental pressure to eat score at 12months with body mass index at 12months .


Neither were associated with feeding mode .


Formula-fed infants had a high level of energy self-regulation and were subjected to low parental control .


Parental control of feeding was mainly influenced by infant growth .


Reminder/recall notifications used by primary care practices increase the rates of childhood immunizations , but fewer than 20 % of primary care practitioners nationally deliver such reminders .


A reminder/recall notification conducted centrally by health departments in collaboration with primary care practices may reduce practice burden , reach children without a primary care practitioner , and decrease the cost of reminders/recalls .


To assess the effectiveness and cost-effectiveness of collaborative centralized ( CC ) vs practice-based ( PB ) reminder/recall approaches using the Colorado Immunization Information System ( CIIS ) .


We performed a randomized pragmatic trial from September 7 , 2012 , through March 17 , 2013 , including 18,235 children aged 19 to 35 months in 15 Colorado counties .


In CC counties , children who needed at least 1 immunization were sent as many as 4 reminders/recalls by mail or autodialed telephone calls by the CIIS .


Primary care practices in these counties were given the option of endorsing the reminder/recall notification by adding the practice name to the message .


In PB counties , primary care practices were invited to web-based reminder/recall training and offered financial support for sending notifications .


Documentation of any new immunization within 6 months constituted the primary outcome ; achieving up-to-date ( UTD ) immunization status was secondary .


We assessed the cost and cost-effectiveness of each approach and used a generalized linear mixed-effects model to assess the effect of the intervention on outcomes .


In PB counties , 24 of 308 primary care practices ( 7.8 % ) attended reminder/recall training and 2 primary care practices ( 0.6 % ) endorsed reminder/recall notifications .


Within CC counties , 129 of 229 practices ( 56.3 % ) endorsed the reminder/recall letter .


Documentation rates for at least 1 immunization were 26.9 % for CC vs 21.7 % for PB counties ( P < .001 ) ; 12.8 % vs 9.3 % of patients , respectively , achieved UTD status ( P < .001 ) .


The effect of CC counties on children 's UTD status was greater when the reminder/recall notification was endorsed by the primary care practice ( 19.2 % vs 9.8 % ; P < .001 ) .


The total cost of the CC reminder/recall was $ 28620 or $ 11.75 per child for any new immunization and $ 24.72 per child achieving UTD status ; the total cost to the 2 practices that conducted PB reminders/recalls was $ 74.00 per child for any immunization and $ 124.45 per child achieving UTD status .


The modeling resulted in an adjusted odds ratio of 1.31 ( 95 % CI , 1.16-1 .48 ) for any new immunization in CC vs PB counties .


A CC reminder/recall notification was more effective and more cost-effective than a PB system , although the effect size was modest .


Endorsement by practices may further increase the effectiveness of CC reminder/recall .


clinicaltrials.gov Identifier : NCT01557621 .


To compare metal-induced artefacts from coiled intracranial aneurysms on 3.0-Tesla and 1.5-Tesla magnetic resonance angiography ( MRA ) , since concerns persist on artefact enlargement at 3.0 Tesla .


We scanned 19 patients ( mean age 53 ; 16 women ) with 20 saccular aneurysms treated with coils only , at 1.5 and 3.0 Tesla according to standard clinical 3D TOF-MRA protocols containing a shorter echo-time but weaker read-out gradient at 3.0 Tesla in addition to intra-arterial digital subtraction angiography ( IA-DSA ) .


Per modality two neuro-radiologists assessed the occlusion status , measured residual flow , and indicated whether coil artefacts disturbed this assessment on MRA .


We assessed relative risks for disturbance by coil artefacts , weighted kappa 's for agreement on occlusion levels , and we compared remnant sizes .


For artefact measurements , a coil model was created and scanned with the same protocols followed by 2D MR scans with variation of echo-time and read-out gradient strength .


Coil artefacts disturbed assessments less frequently at 3.0 Tesla than at 1.5 Tesla ( RR : 0.3 ; 95 % CI : 0.1-0 .8 ) .


On 3.0-Tesla MRA , remnants were larger than on 1.5-Tesla MRA ( difference : 0.7 mm ; 95 % CI : 0.3-1 .1 ) and larger than on IA-DSA ( difference : 1.0 mm ; 95 % CI : 0.6-1 .5 ) with similar agreement on occlusion levels with IA-DSA for both field strengths ( 0.53 ; 95 % CI : 0.23-0 .84 for 1.5-Tesla MRA and IA-DSA ; 0.47 ; 95 % CI : 0.19-0 .76 for 3.0-Tesla MRA and IA-DSA ) .


Coil model artefacts were smaller at 3.0 Tesla than at 1.5 Tesla .


The echo-time influenced artefact size more than the read-out gradient .


Artefacts were not larger , but smaller at 3.0 Tesla because a shorter echo-time at 3.0 Tesla negated artefact enlargement .


Despite smaller artefacts and larger remnants at 3.0 Tesla , occlusion levels were similar for both field strengths .


To better understand the sometimes catastrophic effects of sleep loss on naturalistic decision making , we investigated effects of sleep deprivation on decision making in a reversal learning paradigm requiring acquisition and updating of information based on outcome feedback .


Subjects were randomized to a sleep deprivation or control condition , with performance testing at baseline , after 2 nights of total sleep deprivation ( or rested control ) , and following 2 nights of recovery sleep .


Subjects performed a decision task involving initial learning of go and no go response sets followed by unannounced reversal of contingencies , requiring use of outcome feedback for decisions .


A working memory scanning task and psychomotor vigilance test were also administered .


Six consecutive days and nights in a controlled laboratory environment with continuous behavioral monitoring .


Twenty-six subjects ( 22-40 y of age ; 10 women ) .


Thirteen subjects were randomized to a 62-h total sleep deprivation condition ; the others were controls .


Unlike controls , sleep deprived subjects had difficulty with initial learning of go and no go stimuli sets and had profound impairment adapting to reversal .


Skin conductance responses to outcome feedback were diminished , indicating blunted affective reactions to feedback accompanying sleep deprivation .


Working memory scanning performance was not significantly affected by sleep deprivation .


And although sleep deprived subjects showed expected attentional lapses , these could not account for impairments in reversal learning decision making .


Sleep deprivation is particularly problematic for decision making involving uncertainty and unexpected change .


Blunted reactions to feedback while sleep deprived underlie failures to adapt to uncertainty and changing contingencies .


Thus , an error may register , but with diminished effect because of reduced affective valence of the feedback or because the feedback is not cognitively bound with the choice .


This has important implications for understanding and managing sleep loss-induced cognitive impairment in emergency response , disaster management , military operations , and other dynamic real-world settings with uncertain outcomes and imperfect information .


Transcatheter arterial chemoembolisation ( TACE ) is the treatment of choice for intermediate stage hepatocellular carcinoma ( HCC ) .


Doxorubicin-loaded drug-eluting beads ( DEB ) - TACE is expected to improve the performance of conventional TACE ( cTACE ) .


The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression ( TTP ) , adverse events ( AEs ) , and 2-year survival .


Patients were randomised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death .


Transcatheter arterial chemoembolisation was repeated ` on-demand ' .


We enrolled 177 patients : 89 underwent DEB-TACE and 88 cTACE .


The median number of procedures was 2 in each arm , and the in-hospital stay was 3 and 4 days , respectively ( P = 0.323 ) .


No differences were found in local and overall tumour response .


The median TTP was 9 months in both arms .


The AE incidence and severity did not differ between the arms , except for post-procedural pain , more frequent and severe after cTACE ( P < 0.001 ) .


The 1 - and 2-year survival rates were 86.2 % and 56.8 % after DEB-TACE and 83.5 % and 55.4 % after cTACE ( P = 0.949 ) .


Eastern Cooperative Oncology Group ( ECOG ) , serum albumin , and tumour number independently predicted survival ( P < 0.05 ) .


The DEB-TACE and the cTACE are equally effective and safe , with the only advantage of DEB-TACE being less post-procedural abdominal pain .


Randomized controlled trials ( RCTs ) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention .


However , sometimes a study does not require an RCT in order to answer its primary objective ; a case-finding design may be more appropriate .


The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study .


An example of the new study design is the DOC Study , which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease .


It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design .


The first step of the study design is to obtain participants ' consent .


Individuals are then randomized to one of two groups ; either the ` intervention now ' group or the ` intervention later ' group , that is , participants are placed on a waiting list .


All participants receive the same intervention ; the only difference between the groups is the timing of the intervention .


The design addresses patient preference issues and recruitment issues that can arise in other trial designs .


Potential limitations include differential attrition between study groups and potential demoralization for the ` intervention later ' group .


The ` waiting list case-finding trial ' design is a valuable method that could be applied to case-finding studies ; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial .


Social support has been linked to quitting smoking , but the mechanisms by which social support affects cessation are poorly understood .


The current study tested a stress-buffering model of social support , which posits that social support protects or `` buffers '' individuals from stress related to quitting smoking .


We hypothesized that social support would be negatively associated with risk of relapse , and that this effect would be mediated by reduced withdrawal and depressive symptoms ( i.e. , cessation-related stress ) over time .


Further , we predicted that trait neuroticism would moderate this mediational effect , such that individuals high in negative affectivity would show the greatest stress-buffering effects of social support .


Participants were weight-concerned women ( n = 349 ) ages 18-65 enrolled in a randomized , double-blind , placebo-controlled smoking cessation trial of bupropion and cognitive behavioral therapy .


Social support was assessed at baseline , and biochemically-verified abstinence , withdrawal-related symptoms , and depressive symptoms were assessed at 1 - , 3 - , 6 - , and 12-months follow-up .


Social support was negatively related to risk of relapse in survival models and negatively related to withdrawal symptoms and depression in mixed effects models .


These relationships held after controlling for the effects of pre-quit day negative affect and depression symptoms , assignment to treatment condition , and number of cigarettes smoked per day .


A temporal mediation model showed that the effect of social support on risk of relapse was mediated by reductions in withdrawal symptoms over time but not by depression over time .


Contrary to hypotheses , we did not find that neuroticism moderated this mediation effect .


Increased social support may buffer women from the harmful effects of cessation-related withdrawal symptoms , which in turn improve cessation outcomes .


Repetitive transcranial magnetic stimulation ( rTMS ) is a noninvasive , safe and efficacious technique for treating various neuropsychiatric disorders , but its underlying mechanisms are poorly understood .


A newly developed H-coil allows the stimulation of deeper brain regions .


This study is the first to investigate the effects of deep high-frequency rTMS on brain-derived neurotrophic factor ( BDNF ) serum concentrations in healthy volunteers .


We aimed to evaluate the short-term effect of deep rTMS on BDNF serum concentrations .


This was a double-blind , randomized deep high-frequency rTMS study using an H-coil on a cohort of 13 healthy volunteers ( NCT01106365 ) .


The following stimulation protocols were applied : 18-Hz stimulation of the left dorsolateral prefrontal cortex ( PFC ) , 5-Hz stimulation of the primary motor cortex ( MC ) and sham stimulation in random order .


Blood samples were obtained before , 30 min after and 60 min after each treatment .


The BDNF serum concentration decreased significantly after MC and PFC stimulation , but not after sham stimulation .


Furthermore , BDNF serum level changes were associated with changes in individual alertness .


Although BDNF serum concentrations do not necessarily correlate with BDNF levels in the cerebrospinal fluid or the brain , these results indicate an acute biological effect of deep rTMS on BDNF release , and demonstrate that this change correlates with alertness .


18F-FDG PET can be used to aid in the diagnosis of Alzheimer 's disease ( AD ) and clarify the diagnosis and prognosis of patients with mild cognitive impairment ( MCI ) .


To compare the results of a quantitative analysis of FDG-PET brain images to a standard visual analysis ( SVA ) with regards to the detection of MCI-like hypometabolic pattern in elderly patients with hypertension and subjective , isolated memory complaints .


FDG-PET brain was performed in 71 patients ( mean age , 76.4 5.1 years ; women , 53.5 % ) .


Images were analyzed for the presence of an MCI-like hypometabolic pattern using an SVA by 2 physicians and a voxel-based statistical procedure ( statistical parametric mapping [ SPM ] ) that compared each patient 's images to normal reference samples from 19 elderly individuals obtained using the same PET camera .


The reliability of these analyses was evaluated according to neuropsychological assessment results , including the Grober & Buschke Free and Cued Selective Reminding Test , and a combined analysis by a neuropsychologist .


An MCI-like hypometabolic pattern was documented in 5 patients ( 7 % ) by SVA and 7 patients ( 10 % ) by SPM analysis ; however , only 2 of these patients were selected by both methods .


The group characteristics of the 7 patients identified by the quantitative method were consistent with the MCI pattern , which included a higher rate of abnormal GB-FCSRT in Free Recall ( 57 % vs. 9 % , p < 0.05 ) or in Total Recall ( 29 % vs. 8 % , p < 0.05 ) when compared with other patients .


In contrast , the group identified by SVA did not exhibit these characteristics .


A combined visual and quantitative analysis improves the diagnostic accuracy to detect an MCI-like hypometabolic pattern in elderly patients with hypertension and subjective , isolated memory complaints .


To evaluate the effects of compound whole grain-soybean on insulin resistance and serum adipocytokines levels in impared fasting glucose population .


According to inclusion and exclusion criteria , 163 cases of impared fasting glucose ( IFG ) Chinese Han population from the age of 40 to 75 years old , were screened from 12 community health centers of three main districts of Nanjing city by the multi-stage cluster and simple randomization method from March to September , 2008 .


The IFG subjects were randomly divided into the intervention group ( 87 individuals ) and control group ( 76 individuals ) by quasi-experimental design .


The intervention group was provided with compound whole grain-soybean and health education , while only health education was provided for the control group .


Body mass index ( BMI ) , waist-to-hip ratio ( WHR ) , lipid profiles , fasting blood glucose ( FBG ) , fasting insulin ( FINS ) and homeostasis model assessment of insulin resistance ( HOMA-IR ) , adipocytokines including leptin , lipocalin 2 ( LCN-2 ) and adiponectin ( ADP ) levels were measured before and after the half a year intervention period .


Chi square test was used to analyze the distribution differences .


Two-sample t-test was used to compare the differences of the two groups before and after the half a year intervention period , and paired t-test was used to compare the differences between before and after intervention in the intervention group or control group .


Wilcoxon rank sum test was used to compare the differences of all indexes between after and before dietary intervention .


After dietary intervention for half a year on the IFG population , BMI ( ( 24.87 3.69 ) kg/m ( 2 ) ) , FBG ( ( 6.27 0.24 ) mmol/L ) , FINS ( ( 7.14 1.05 ) mU/L ) , HOMA-IR ( 1.99 0.31 ) , leptin ( ( 13.07 2.22 ) g / L ) , LCN-2 ( ( 67.42 18.20 ) g/L ) of intervention group were decreased significantly compared to the levels of BMI ( ( 25.16 4.07 ) kg/m ( 2 ) ) , FBG ( ( 6.40 0.28 ) mmol/L ) , FINS ( ( 7.32 1.54 ) mU/L ) , HOMA-IR ( 2.08 0.45 ) , leptin ( ( 13.43 2.52 ) g/L ) , LCN-2 ( ( 74.87 17.81 ) g/L ) before dietary intervention , t values were 4.48 , 7.08 , 2.05 , 3.39 , 3.28 and 6.36 , respectively , and all P values were < 0.05 , while ADP ( ( 5.07 1.51 ) mg/L ) of intervention group after dietary intervention was increased significantly compared to the level of ADP ( ( 4.92 1.53 ) mg/L ) before dietary intervention , t = -2.47 and P < 0.05 .


The medians ( P25 , P 75 ) of differences after and before dietary intervention in the intervention group were BMI ( -0.25 ( -0.68 , 0.02 ) kg/m ( 2 ) ) , FBG ( -0.08 ( -0.20 , 0.00 ) mmol/L ) , FINS ( -0.15 ( -0.32 , 0.00 ) mU/L ) , HOMA-IR ( -0.07 ( -0.12 , -0.03 ) ) , leptin ( -0.36 ( -0.77 , 0.12 ) g/L ) , LCN-2 ( -5.85 ( -14.29 , -0.71 ) g/L ) and ADP ( 0.15 ( -0.13 , 0.36 ) mg/L ) , and the medians of differences of after and before dietary intervention in the control group were BMI ( 0.00 ( -0.23 , 0.29 ) kg/m ( 2 ) ) , FBG ( 0.00 ( -0.03 , 0.04 ) mmol/L ) , FINS ( -0.01 ( -0.13 , 0.04 ) mU/L ) , HOMA-IR ( -0.01 ( -0.05 , 0.02 ) ) , leptin ( -0.07 ( -0.57 , 0.46 ) g/L ) , LCN-2 ( -0.85 ( -5.39 , 1.63 ) g/L ) and ADP ( 0.02 ( -0.19 , 0.13 ) mg/L ) .


There were significantly statistical differences between them ( Z values were -3.65 , -4.88 , -3.08 , -5.23 , -2.16 , -4.43 and 3.05 , all P values were < 0.05 ) .


Dietary intervention of compound whole grain-soybean can improves glucose level , increase insulin sensitivity and ameliorate insulin resistance state of IFG population .


There is limited evidence supporting use of physical therapy for hip osteoarthritis .


To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis .


Randomized , placebo-controlled , participant - and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm ( range , 0-100 mm ; 100 indicates worst pain possible ) and hip osteoarthritis confirmed by radiograph .


Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up ( May 2010-February 2013 ) INTERVENTIONS : Participants attended 10 treatment sessions over 12 weeks .


Active treatment included education and advice , manual therapy , home exercise , and gait aid if appropriate .


Sham treatment included inactive ultrasound and inert gel .


For 24 weeks after treatment , the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly .


Primary outcomes were average pain ( 0 mm , no pain ; 100 mm , worst pain possible ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , 0 no difficulty to 68 extreme difficulty ) at week 13 .


Secondary outcomes were these measures at week 36 and impairments , physical performance , global change , psychological status , and quality of life at weeks 13 and 36 .


Ninety-six patients ( 94 % ) completed week 13 measurements and 83 ( 81 % ) completed week 36 measurements .


The between-group differences for improvements in pain were not significant .


For the active group , the baseline mean ( SD ) visual analog scale score was 58.8 mm ( 13.3 ) and the week-13 score was 40.1 mm ( 24.6 ) ; for the sham group , the baseline score was 58.0 mm ( 11.6 ) and the week-13 score was 35.2 mm ( 21.4 ) .


The mean difference was 6.9 mm favoring sham treatment ( 95 % CI , -3.9 to 17.7 ) .


The function scores were not significantly different between groups .


The baseline mean ( SD ) physical function score for the active group was 32.3 ( 9.2 ) and the week-13 score was 27.5 ( 12.9 ) units , whereas the baseline score for the sham treatment group was 32.4 ( 8.4 ) units and the week-13 score was 26.4 ( 11.3 ) units , for a mean difference of 1.4 units favoring sham ( 95 % CI , -3.8 to 6.5 ) at week 13 .


There were no between-group differences in secondary outcomes ( except greater week-13 improvement in the balance step test in the active group ) .


Nineteen of 46 patients ( 41 % ) in the active group reported 26 mild adverse effects and 7 of 49 ( 14 % ) in the sham group reported 9 mild adverse events ( P = .003 ) .


Among adults with painful hip osteoarthritis , physical therapy did not result in greater improvement in pain or function compared with sham treatment , raising questions about its value for these patients .


anzctr.org.au Identifier : ACTRN12610000439044 .


To determine whether antibiotic prescribing can be reduced in nursing homes using a quality improvement ( QI ) program that involves providers , staff , residents , and families .


A 9-month quasi-experimental trial of a QI program in 12 nursing homes ( 6 comparison , 6 intervention ) conducted from March to November 2011 .


Nursing homes in two regions of North Carolina , roughly half of whose residents received care from a single practice of long-term care providers .


All residents , including 1,497 who were prescribed antibiotics .


In the intervention sites , providers in the single practice and nursing home nurses received training related to prescribing guidelines , including situations for which antibiotics are generally not indicated , and nursing home residents and their families were sensitized to matters related to antibiotic prescribing .


Feedback on prescribing was shared with providers and nursing home staff monthly .


Rates of antibiotic prescribing for presumed urinary tract , skin and soft tissue , and respiratory infections .


The QI program reduced the number of prescriptions ordered between baseline and follow-up more in intervention than in comparison nursing homes ( adjusted incidence rate ratio = 0.86 , 95 % confidence interval = 0.79-0 .95 ) .


Based on baseline prescribing rates of 12.95 prescriptions per 1,000 resident-days , this estimated adjusted incidence rate ratio implies 1.8 prescriptions avoided per 1,000 resident-days .


This magnitude of effect is unusual in efforts to reduce antibiotic use in nursing homes .


Outcomes could be attributed to the commitment of the providers ; outreach to providers and staff ; and a focus on common clinical situations in which antibiotics are generally not indicated ; and suggest that similar results can be achieved on a wider scale if similar commitment is obtained and education provided .


To assess the efficacy of drugs containing herbal extracts in the treatment of Benign Prostatic Hyperplasia .


The clinical trial study was performed in 2011-2012 at Imam Reza Hospital , Mashhad , Iran .


One hundred patients with Benign Prostatic Hyperplasia were randomly divided into 2 equal groups receiving prostafit and prazosin , respectively .


Quality of life and International Prostatic Symptom Score questionnaire were filled and prostate specific antigen level , uroflowmetry and prostate volume were measured at baseline , 3 and 6 months after the medication .


The data was analysed using SPSS 15 and repeated measure analysis of variance .


No complications were observed during and after the treatment .


International Prostatic Symptom Score had significant differences at baseline and 6 months after the treatment in both groups , specially in group 2 18 vs 22 ( 36 % versus 44 % ) .


Quality of life was better in group 2 , 25.5 vs 31.5 ( 51 % versus 63 % ) .


prostate specific antigen level did not change after the treatment and there was no remarkable difference in either group .


Prostafit is an effective and safe treatment in Benign Prostatic Hyperplasia but not as much as prozasin .


Image-guided intensity modulated radiation therapy ( IG-IMRT ) allows significant dose reductions to organs at risk in prostate cancer patients .


However , clinical data identifying the benefits of IG-IMRT in daily practice are scarce .


The purpose of this study was to compare dose distributions to organs at risk and acute gastrointestinal ( GI ) and genitourinary ( GU ) toxicity levels of patients treated to 78 Gy with either IG-IMRT or 3D-CRT .


Patients treated with 3D-CRT ( n = 215 ) and IG-IMRT ( n = 260 ) receiving 78 Gy in 39 fractions within 2 randomized trials were selected .


Dose surface histograms of anorectum , anal canal , and bladder were calculated .


Identical toxicity questionnaires were distributed at baseline , prior to fraction 20 and 30 and at 90 days after treatment .


Radiation Therapy Oncology Group ( RTOG ) grade 1 , 2 , and 3 endpoints were derived directly from questionnaires .


Univariate and multivariate binary logistic regression analyses were applied .


The median volumes receiving 5 to 75 Gy were significantly lower ( all P < .001 ) with IG-IMRT for anorectum , anal canal , and bladder .


The mean dose to the anorectum was 34.4 Gy versus 47.3 Gy ( P < .001 ) , 23.6 Gy versus 44.6 Gy for the anal canal ( P < .001 ) , and 33.1 Gy versus 43.2 Gy for the bladder ( P < .001 ) .


Significantly lower grade 2 toxicity was observed for proctitis , stool frequency 6/day , and urinary frequency 12/day .


IG-IMRT resulted in significantly lower overall RTOG grade 2 GI toxicity ( 29 % vs 49 % , respectively , P = .002 ) and overall GU grade 2 toxicity ( 38 % vs 48 % , respectively , P = .009 ) .


A clinically meaningful reduction in dose to organs at risk and acute toxicity levels was observed in IG-IMRT patients , as a result of improved technique and tighter margins .


Therefore reduced late toxicity levels can be expected as well ; additional research is needed to quantify such reductions .


To assess the possible predictive factors for permanent laryngoplasty ( PL ) in patients with acute unilateral vocal fold paralysis ( UVFP ) , and to assess the effects of early vocal cord hyaluronic acid injection .


Prospective cohort study .


Patients diagnosed with UVFP within the previous 6 months were enrolled .


Initial and follow-up videolaryngostroboscopy , voice laboratory analysis , laryngeal electromyography , and Voice Outcome Survey were performed .


Fifty newly diagnosed UVFP patients were recruited .


Eight were excluded after 12 months of follow-up and data for 42 patients were analyzed .


In patients treated conservatively , the glottal gap was measured on presentation .


Normalized glottal gap area ( NGGA ) was the only predictor of PL ( P = 0.036 ) according to multivariate logistic regression analysis .


A cutoff value of 7.36 resulted in sensitivity of 85.7 % and specificity of 80.0 % for predicting future PL .


The PL rate was significantly higher in patients with an initial NGGA > 7.36 compared with 7.36 .


( 6/9 vs. 1/13 ; ( 2 ) = 6.71 ; P = 0.010 ) .


Among patients with an initial NGGA > 7.36 , those who accepted early hyaluronic acid injection had a significantly lower rate of PL ( 1/11 vs. 6/9 ; ( 2 ) = 7.21 ; P = 0.007 ) and better social and emotional role functioning at follow-up .


The glottal gap on presentation is a robust early predictor of PL .


Early , office-based hyaluronic acid intracordal injection can reduce the need for PL in patients with a large NGGA .


The role of folate in skin carcinogenesis is unclear , with experimental data suggesting potentially protective but also deleterious effects .


Our main objective was to investigate the prospective association between dietary folate intake and risks of skin cancer ( overall ) , nonmelanoma skin cancer ( NMSC ) , and basal cell carcinoma ( BCC ) .


As an exploratory analysis , we also investigated the prospective association between erythrocyte folate concentration and skin cancer risk .


In this study , we included 5880 participants in the Supplmentation en Vitamines et Minraux Antioxydants ( SU.VI.MAX ) cohort ( follow-up : 1994-2007 ) who completed at least six 24-h dietary records during the first 2 y of the study .


Associations between sex-specific tertiles of dietary and erythrocyte folate and skin cancer risk were assessed by using multivariate Cox proportional hazards models .


After a median follow-up of 12.6 y , 144 incident skin cancers were diagnosed .


Dietary folate intake was associated with increased risk of overall skin cancer [ HR for tertile 3 compared with tertile 1 ( HR ( T3vs.T1 ) ) : 1.79 ; 95 % CI : 1.07 , 2.99 ; P-trend = 0.03 ] , NMSC ( HR ( T3vs.T1 ) : 1.85 ; 95 % CI : 1.06 , 3.23 ; P-trend = 0.03 ) , and BCC ( HR ( T3vs.T1 ) : 1.78 ; 0.98 , 3.24 ; P-trend = 0.05 ) .


This association was observed in women ( corresponding P-trend = 0.007 , 0.009 , and 0.009 , respectively ) but not in men ( P-trend = 0.8 , 0.8 , and 0.9 , respectively ) .


P-interaction values between tertiles of dietary folate intake and sex were 0.04 , 0.02 , and 0.02 for overall skin cancer , NMSC , and BCC , respectively .


Erythrocyte folate concentration was directly associated with increased risk of overall skin cancer ( HR ( T3vs.T1 ) : 2.54 ; 95 % CI : 0.95 , 6.81 ; P-trend = 0.03 ) , NMSC ( HR ( T3vs.T1 ) : 3.49 ; 95 % CI : 1.11 , 11.0 ; P-trend = 0.01 ) , and BCC ( HR ( T3vs.T1 ) : 7.44 ; 95 % CI : 1.57 , 35.3 ; P-trend = 0.004 ) ( men and women combined ) .


This prospective study suggests an association between dietary folate intake and erythrocyte folate concentration and increased risk of overall skin cancer , NMSC , and BCC .


Although several mechanistic hypotheses and 2 previous large prospective studies on BCC are in line with these results , epidemiologic literature is limited , and future research is needed to better elucidate the potential role of folate in the cause of skin cancers .


This trial compared the efficacy/safety of two IV doses of AZD9773 , a polyclonal antibody to tumor necrosis factor - , in adult patients with severe sepsis/septic shock .


Multicenter , randomized , double-blind , placebo-controlled phase IIb trial .


ICUs in seven countries ( Australia , Belgium , Canada , Czech Republic , Finland , France , and Spain ) .


Patients 18 years old or older with severe sepsis and/or septic shock .


Patients were required to have 1 ) objective clinical evidence of infection ; 2 ) at least two of four systemic inflammatory response syndrome criteria ; and 3 ) cardiovascular and/or respiratory sepsis-related failure .


Patients were randomized 1:1:1 to a single loading infusion of AZD9773 250 U/kg followed by 50 U/kg every 12 hours ( low dose , n = 100 ) , a single loading infusion of AZD9773 500 U/kg followed by 100 U/kg every 12 hours ( high dose , n = 100 ) , or placebo ( n = 100 ) for 5 days .


Follow-up assessments were performed up to day 90 .


Mean number of ventilator-free days ( primary endpoint ) did not differ between low-dose ( 19.7 d ) or high-dose AZD9773 ( 17.3 d ) and placebo ( 18.3 d ) ( one-sided p = 0.18 and 0.74 , respectively ) .


Mortality rates were comparable across treatment groups ; relative risk of death versus placebo at day 29 was 0.80 for low-dose AZD9773 ( one-sided p = 0.25 ) and 1.64 for high-dose AZD9773 ( p = 0.97 ) .


Most patients experienced at least one treatment-emergent adverse event ( 87.8 % in AZD9773-treated patients , 92.9 % in placebo patients ) although most were mild/moderate in nature .


No differences in the incidence of adverse events or laboratory or vital sign abnormalities were observed between groups .


AZD9773 rapidly and efficiently decreased plasma tumor necrosis factor - concentration in patients with severe sepsis/septic shock , but this effect did not translate into clinical benefit .


To study the effectiveness of the addition of citicoline to patching in the treatment of amblyopia in the age group of 4-13 years .


A randomized controlled trial , which included patients who were randomly divided into two groups .


Both the groups received patching therapy till plateau was achieved in phase 1 of the study .


Then in phase 2 , group I received citicoline plus patching and group II continued to receive only patching .


Outcome was measured by the visual acuity in logMAR every month in phase 1 till plateau was achieved and then for 12 months in phase 2 .


No significant difference was found in the mean visual acuities in these two groups in phase 1 till plateau was reached .


In phase 2 , for the initial four months , there was no significant difference in the visual acuities in these two groups , at the respective intervals .


However , five months onward , up to 12 months , there was a significant difference in the visual acuities in these groups.The result was the same in younger patients ( < seven years of age ) as well as in older patients ( > seven years of age ) .


In phase 2 , the mean proportional improvement in group I was significantly more than that in group II , at two months and onward , at the respective intervals .


The improvement in visual acuity with citicoline plus patching was significantly more than that with patching alone , in one year of treatment .


To compare breast cancer incidence and mortality up to 25 years in women aged 40-59 who did or did not undergo mammography screening .


Follow-up of randomised screening trial by centre coordinators , the study 's central office , and linkage to cancer registries and vital statistics databases .


15 screening centres in six Canadian provinces,1980-85 ( Nova Scotia , Quebec , Ontario , Manitoba , Alberta , and British Columbia ) .


89,835 women , aged 40-59 , randomly assigned to mammography ( five annual mammography screens ) or control ( no mammography ) .


Women aged 40-49 in the mammography arm and all women aged 50-59 in both arms received annual physical breast examinations .


Women aged 40-49 in the control arm received a single examination followed by usual care in the community .


Deaths from breast cancer .


During the five year screening period , 666 invasive breast cancers were diagnosed in the mammography arm ( n = 44,925 participants ) and 524 in the controls ( n = 44,910 ) , and of these , 180 women in the mammography arm and 171 women in the control arm died of breast cancer during the 25 year follow-up period .


The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 ( 95 % confidence interval 0.85 to 1.30 ) .


The findings for women aged 40-49 and 50-59 were almost identical .


During the entire study period , 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer , and 500 and 505 , respectively , died of breast cancer .


Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm ( hazard ratio 0.99 , 95 % confidence interval 0.88 to 1.12 ) .


After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm , attributable to over-diagnosis .


Annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available .


Overall , 22 % ( 106/484 ) of screen detected invasive breast cancers were over-diagnosed , representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial .


The aim of this study was to evaluate the compatibility of external measurements of parameters characterizing scoliosis using the photogrammetric method .


The study involved 120 children between the ages of 7 and 11 years in Podkarpackie ( Poland ) .


Measurements of body posture characteristics were performed using the photogrammetric method with mora projection .


Each person was examined twice , once by two different therapists , with a time lapse of 20 minutes in between examinations .


High accuracy and no statistical significance were found among different measurements of asymmetry parameters characterizing the shoulder blades and hips .


Regularities were also found in the characteristic measurements of curves of scoliosis .


The POSTI parameter showed a significant variation and lack of compatibility of results .


( 1 ) The photogrammetric method used to assess the pathological changes caused by scoliosis gives significant results in terms of parameters characterizing the position of the shoulder blades and shoulders , as well as pelvis rotation .


( 2 ) High compliance measurements are also characterized by the length of the right and left arcs of scoliosis .


In two of three phase 3 trials , pirfenidone , an oral antifibrotic therapy , reduced disease progression , as measured by the decline in forced vital capacity ( FVC ) or vital capacity , in patients with idiopathic pulmonary fibrosis ; in the third trial , this end point was not achieved .


We sought to confirm the beneficial effect of pirfenidone on disease progression in such patients .


In this phase 3 study , we randomly assigned 555 patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone ( 2403 mg per day ) or placebo for 52 weeks .


The primary end point was the change in FVC or death at week 52 .