To determine the efficacy and safety of bitopertin ( RG@ ) , 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 @ proof-of-concept trial involved @ patients with schizophrenia and predominant negative symptoms across @ sites worldwide .


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


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


In the per-protocol population , @ weeks of treatment with bitopertin was associated with a significant reduction of negative symptoms in the @-mg/d ( mean -LSB- SE -RSB- reduction in negative symptoms score , -@ % -LSB- @ % -RSB- ; P = @ ) and @-mg/d ( mean -LSB- SE -RSB- , -@ % -LSB- @ % -RSB- ; P = @ ) bitopertin groups , a significantly higher response rate and a trend toward improved functioning in the @-mg/d group when compared with placebo ( mean -LSB- SE -RSB- , -@ % -LSB- @ % -RSB- ) .


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


Estimates of bitopertin binding to glycine transporter type @ 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 .


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 @,@-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 @ % confidence intervals ( CI ) between polyphenol intake and mortality were estimated using time-dependent Cox proportional hazard models .


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


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


Among the polyphenol subclasses , stilbenes and lignans were significantly associated with reduced all-cause mortality ( HR = @ ; @ % CI @ to @ ; P for trend = @ and HR = @ ; @ % CI @ to @ ; P for trend = @ , 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 .


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 ) .


@ patients were included .


Mean age was @ ( SD @ ) years and mean FEV@ was @ ( SD @ ) % 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 @ , @ % CI @ to @ , p = @ ) and SBP ( adjusted OR @ , @ % CI @ to @ , p = @ ) 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 ( @,@ IU ) in comparison to standard dose ( @,@ ) IU of Vitamin D for increasing serum @ ( OH ) D levels and achieving radiological recovery in nutritional rickets .


Randomized , open-labeled , controlled trial .


Tertiary care hospital .


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


Oral vitamin D@ as @,@ IU ( Group @ ; n = @ ) or @,@ IU ( Group @ ; n = @ ) in a single day .


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


Serum @ ( OH ) D levels -LSB- geometric mean ( @ % CI ) -RSB- increased significantly from baseline to @ weeks after therapy in both the groups -LSB- Group @ : @ ( @ ) to @ ( @ @ ) ng/mL , P < @ -RSB- ; Group @ : @ ( @ ) to @ ( @ , P < @ -RSB- .


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


Radiological healing occurred in all children by @ weeks .


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


Relative change -LSB- ratio of geometric mean ( @ % CI ) -RSB- in serum PTH and alkaline phosphatase , @ weeks after therapy , were @ ( @ ) and @ ( @ ) , respectively .


The serum @ ( OH ) D levels were deficient ( < @ ng/mL ) in @ % ( @/@ ) children after @ weeks of intervention -LSB- Group @ : @/@ ( @ % ) ; Group @ : @/@ ( @ % ) -RSB- .


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


Hypercalcemia was documented in @ children at @ weeks ( @ in each Group ) and @ children at @ weeks ( @ in Group @ and @ in Group @ ) .


None of the participants had hypercalciuria or hypervitaminosis D.


A dose of @,@ IU of vitamin D@ is comparable to @,@ 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 , @ 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 @b clinical trial , sera were collected from a total of @ DM or PM adult patients receiving either placebo for @ months or sifalimumab for @ months .


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


Muscle biopsies from selected patients were stained for T cell infiltration using an anti-CD@ 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-@RA , TNF receptor @ ( TNFR@ ) and IL-@ .


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-@RA correlated with favourable manual muscle test @ ( MMT-@ ) 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-@RA 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 @ 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 @-month , randomized , rater-blinded clinical trial involving @ adolescent patients with early-onset psychosis and either or both of their parents .


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


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 , @ % of patients in the psychoeducational group and @ % patients in the nonstructured group had visited the emergency department ( = @ , df = @ , p = @ ) .


The improvement in negative symptoms was more pronounced in the psychoeducational group ( @ -LSB- @ -RSB- ) than in the nonstructured group ( @ -LSB- @ -RSB- ) ( p = @ ) .


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 @ % 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 @ patients , @ ( @ % ) had previously failed VKA treatment -LSB- main reasons : poor international normalized ratio ( INR ) control @ % , refusal @ % , bleeding on VKA @ % -RSB- .


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 @ ) and major bleeding ( P interaction @ ) and were also consistent among different subgroups of patients who had previously failed VKA therapy defined by reasons for unsuitability , age , sex , renal function , CHADS@ 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 LKM@ 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 LKM@ 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 @ 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 .


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


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


LKM@ administration may exert antipruritic effects by increasing KYNA production .


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


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 .


@ pregnant women with gestational age @-@ 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 @ 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 @ % of women , lAP was less than @ mmHg ( physiologically normal ) , in @ % -- from @ to @ mmHg ( degree I of intra-abdominal hypertension ( IAH ) ) , in @ % -- from @ to @ mmHg ( degree II of IAH ) , in @ % -- from @ to @ mmHg ( degree III of IAH ) .


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


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 @ public middle schools in New York City , enrolling @ 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 @ months after intervention .


At @ 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 @ trial , @ patients were randomized @:@ to receive edoxaban @mg once daily ( n = @ ) or enoxaparin sodium ( enoxaparin ) @IU ( equivalent to @mg ) twice daily ( n = @ ) for @ to @days .


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 @ % and @ % , respectively , while any bleeding event occurred in @ % and @ % of patients , respectively .


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


All events were asymptomatic deep vein thrombosis .


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


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


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 @ to @ in the LIFE Study underwent baseline measurement of the ABI , @-m walk , and @-m walking velocity .


Participants were classified as follows : definite PAD ( ABI < @ ) , borderline PAD ( ABI @ to @ ) , low normal ABI ( ABI @ to @ ) , and no PAD ( ABI @ to @ ) .


Of @ participants , @ ( @ % ) had definite PAD , @ ( @ % ) had borderline PAD , @ ( @ % ) had low normal ABI , and @ ( @ % ) had no PAD .


Among those with definite PAD , @ % were asymptomatic .


Adjusting for age , sex , race , body mass index , smoking , and comorbidities , lower ABI was associated with longer mean @-m walk time : ( definite PAD = @ seconds ; borderline PAD = @ seconds ; low normal ABI = @ seconds ; and no PAD = @ seconds -LSB- P < @ -RSB- ) .


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


Among older community-dwelling men and women , @ % had PAD and @ % 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 .


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 ( T@DM ) 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 T@DM .


In a randomized , double-blind , placebo-controlled @-week crossover trial with a @ week wash-out period , oral supplements of @ mmol of magnesium-pidolate or placebo were administered twice a day to @ healthy normomagnesemic participants , aged @-@ 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/T@DM ( trial registration at clinicaltrial.gov ID : NCT@ ; @th of Aug @ ) .


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 @ to February @ .


The patients were randomly allocated into a HFCWO ( H ) group and a control group using SAS @ 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 @ days were collected .


At the same time , heart rate , blood pressure , respiratory rate , SpO@ 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 -LSB- ( @ @ ) d and ( @ @ ) d , P < @ -RSB- .


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


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


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


Severe ventilator alarm ( level @ ) occurred in @ % 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 @ days .


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


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 @ @ m , range : @ to @ m below the surface ) for the @ % strontium group on days @ and @ ( pre-acid ) was @ % ( SD : @ % , @ % confidence interval -LSB- CI -RSB- = @ % to @ % ) and on days @ and @ ( post-acid ) was @ % ( SD : @ % , CI = @ % to @ % ) .


For @ % arginine on days @ and @ ( post-acid ) , the proportion was @ % ( SD : @ % , CI = @ % to @ % ) .


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


The @ % arginine on days @ and @ ( 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 = @ ) , all-cause mortality ( n = @ ) , CV death ( n = @ ) or the coronary endpoint ( n = @ ) , was evaluated in @,@ patients > @ years of age with ischemic systolic HF in the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) population , who were randomly assigned to @ 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 = @ , p < @ ) .


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 @ 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 @ focus group discussions with the following groups of participants : mothers ( n = @ ) , fathers ( n = @ ) and grandmothers ( n = @ ) for @ participants .


We conducted @ IDIs with mothers to preterm newborns ( n = @ ) , TBAs ( n = @ ) and traditional healers ( n = @ ) .


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


Data collection took place between October @ and January @ .


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 GNA@ , resulting in mitogen-activated protein kinase pathway activation .


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


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


One hundred one patients were randomized in a @:@ ratio to receive selumetinib , @ mg orally twice daily on a continual basis ( n = @ ) , or chemotherapy ( temozolomide , @ mg/m@ orally daily for @ of every @ days , or dacarbazine , @ mg/m@ intravenously every @ days -LSB- investigator choice -RSB- ; n = @ ) until disease progression , death , intolerable adverse effects , or withdrawal of consent .


After primary outcome analysis , @ patients were registered and @ treated with selumetinib without randomization to complete the planned @-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 @ , @ .


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


Median progression-free survival among patients randomized to chemotherapy was @ weeks ( @ % CI , @-@ @ weeks ; median treatment duration , @ weeks ; interquartile range -LSB- IQR -RSB- , @-@ weeks ) and among those randomized to selumetinib was @ weeks ( @ % CI , @-@ @ weeks ; median treatment duration , @ weeks ; IQR , @-@ @ weeks ) ( hazard ratio , @ ; @ % CI , @-@ @ ; P < @ ) .


Median overall survival time was @ months ( @ % CI , @-@ @ months ) with chemotherapy and @ months ( @ % CI , @-@ @ months ) with selumetinib ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


No objective responses were observed with chemotherapy .


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


Treatment-related adverse events were observed in @ % of patients treated with selumetinib , with @ % requiring at least @ 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 .


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 @ transfemoral ( TF ) and @ transapical ( TA ) TAVR patients , and @ AVR patients ; the PARTNER-B arm included @ TF-TAVR patients and @ 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 @ months .


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


Cardiovascular , noncardiovascular , and uncategorizable deaths for TF-TAVR were @ % , @ % , and @ % , respectively , versus @ % , @ % , and @ % , respectively , for TA-TAVR and @ % , @ % , and @ % , respectively , for AVR .


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


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 ( @ 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 @ and @ h of intensive care unit stay to detect acute kidney injury markers .


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


Normally distributed continuous variables were described as mean standard deviation and non-normally distributed data were presented as the median -LSB- @th-@th percentiles -RSB- .


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


No difference was found between pre - and postoperative CCr in the PP group ( @ @ vs @ @ ml/min , P = @ ) , while its statistically significant perioperative decrement was observed in the NP group ( @ @ vs @ @ ml/min , P < @ ) .


The PP group showed significantly lower urinary levels of NAG at @ h postoperatively ( P = @ ) , and NGAL at sternum closure ( P = @ ) , @ h ( P < @ ) and @ h ( P = @ ) 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 = @ ) with fasting low-density lipoprotein cholesterol ( LDL-C ) @mg/dL and < @mg/dL and triglycerides ( TG ) @mg/dL .


In a double-blind , randomized , crossover design ( @-day treatments , @-day washout between ) , @ tablespoons/day CO or EVOO were provided in @ servings study product/day ( muffin , roll , yogurt ) as part of a weight-maintenance diet ( @ % fat , < @ % saturated fat , < @mg 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 @ ( @ ) , total cholesterol ( total-C ) @ ( @ ) , non-high-density lipoprotein ( non-HDL ) - C @ ( @ ) , HDL-C @ ( @ ) , total-C/HDL-C @ ( @ ) , and TG @ ( @ ) .


CO resulted in significantly larger least-squares mean % changes ( all P < @ vs EVOO ) from baseline in LDL-C -@ vs -@ , total-C -@ vs -@ , non-HDL-C -@ vs -@ , and total-C/HDL-C -@ vs @ .


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


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


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 @ 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 @-min telephone interview at baseline and at the end of academic years @ and @ .


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 @ .


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 @ 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 CD@ ( alpha subunit of the interleukin-@ receptor ) and modulates interleukin-@ signaling .


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


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


The primary end point was the annualized relapse rate .


The annualized relapse rate was lower with daclizumab HYP than with interferon beta-@a ( @ vs. @ ; @ % lower rate with daclizumab HYP ; P < @ ) .


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


At week @ , the estimated incidence of disability progression confirmed at @ weeks was @ % with daclizumab HYP and @ % with interferon beta-@a ( P = @ ) .


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


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


Among patients with relapsing-remitting multiple sclerosis , daclizumab HYP showed efficacy superior to that of interferon beta-@a 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 @ weeks .


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


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


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 -LSB- LMA ( LMA Unique ) , Air-Q ( Air-Q Intubating Laryngeal Airway Reusable ) and CobraPLA ( Cobra Perilaryngeal Airway ) -RSB- 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 @ cm , Air-Q @ cm , CobraPLA @ cm ; P = @ ) .


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 @ % of the LMA patients and @ % 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 ( @ % males ; mean age @y @mo , SD @y @mo ; Manual Ability Classification System level I , n = @ ; level II , n = @ ) were randomly allocated , and @ received either hybrid-CIMT ( n = @ ) or standard care ( n = @ ) .


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


Outcomes were assessed at baseline , @weeks , and @weeks after treatment .


Groups were equivalent at baseline .


Standard care achieved greater gains on satisfaction with occupational performance after intervention ( estimated mean difference -@ , @ % CI -@ to -@ ; p = @ ) and Assisting Hand Assessment at @weeks ( estimated mean difference @ , @ % CI @-@ @ ; p = @ ) .


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 @ and February @ , 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 @,@ .


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


We identified and trained @ 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 @-month follow-up assessment .


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


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


The non-significant hospitals at @months 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 @ individuals with subacute stroke were assessed before ( T@ ) and after anodal stimulation ( T@ ) and after a successive session of motor rehabilitation ( T@ ) 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 = @ ; S-tDCS : p = @ ) .


Post hoc analysis revealed a significant stimulation effect only for A-tDCS ( p = @ between T@ and T@ ) and not for S-tDCS , whereas the rehabilitation effect ( between T@ and T@ ) 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-@ ( ( @ ) I ) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma .


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


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


Rates of tumour recurrence and overall survival were evaluated .


The probabilities of recurrence at @ - , @ - , and @-years were @ % , @ % , and @ % in the RFA - ( @ ) I group ; and @ % , @ % , and @ % in the RFA-only group , respectively .


The recurrence rate in the RFA - ( @ ) I group was significantly lower than in the RFA-only group ( HR , @ ; @ % CI , @-@ @ ; p = @ by log-rank test ) .


Local and intrahepatic recurrence was significantly lower in the RFA - ( @ ) I group than in the RFA-only group ( @ % vs. @ % , p = @ by log-rank test ; @ % vs. @ % , p = @ by log-rank test ) .


The probabilities of survival at @ - , @ - , and @-years were @ % , @ % , and @ % in the RFA - ( @ ) I group and @ % , @ % , and @ % in the RFA-only group , respectively .


The survival rate in the RFA - ( @ ) I group was significantly better than in the RFA-only group ( HR , @ ; @ % CI , @-@ @ ; p = @ 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 - ( @ ) I and RFA-only for patients with small HCCs ( @ cm ) .


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


ClinicalTrials.gov Identifier : NCT@ .


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 @ year of treatment .


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


Fifty-eight ( @ % ) of the @ patients achieved CID at @ or more visits including @ who received blinded MEP , @ while receiving MTX monotherapy , and @ 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 @ response at @ months had a significantly greater proportion of followup visits in CID , compared to those who failed to achieve this improvement ( p < @ ) .


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


Shorter disease duration prior to treatment , a robust response at @ 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 @ .


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 @ formula-fed and @ breast-fed infants from a randomised controlled trial , who were prospectively followed from under @months of age to @months of age .


Anthropometry was recorded at baseline , @ , @ and @months of age .


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


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 @months than parents of breast-fed infants .


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


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 @ % 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 @ , @ , through March @ , @ , including @,@ children aged @ to @ months in @ Colorado counties .


In CC counties , children who needed at least @ immunization were sent as many as @ 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 @ 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 , @ of @ primary care practices ( @ % ) attended reminder/recall training and @ primary care practices ( @ % ) endorsed reminder/recall notifications .


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


Documentation rates for at least @ immunization were @ % for CC vs @ % for PB counties ( P < @ ) ; @ % vs @ % of patients , respectively , achieved UTD status ( P < @ ) .


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


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


The modeling resulted in an adjusted odds ratio of @ ( @ % CI , @-@ @ ) 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 .


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


We scanned @ patients ( mean age @ ; @ women ) with @ saccular aneurysms treated with coils only , at @ and @ Tesla according to standard clinical @D TOF-MRA protocols containing a shorter echo-time but weaker read-out gradient at @ 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 @D MR scans with variation of echo-time and read-out gradient strength .


Coil artefacts disturbed assessments less frequently at @ Tesla than at @ Tesla ( RR : @ ; @ % CI : @-@ @ ) .


On @-Tesla MRA , remnants were larger than on @-Tesla MRA ( difference : @ mm ; @ % CI : @-@ @ ) and larger than on IA-DSA ( difference : @ mm ; @ % CI : @-@ @ ) with similar agreement on occlusion levels with IA-DSA for both field strengths ( @ ; @ % CI : @-@ @ for @-Tesla MRA and IA-DSA ; @ ; @ % CI : @-@ @ for @-Tesla MRA and IA-DSA ) .


Coil model artefacts were smaller at @ Tesla than at @ Tesla .


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


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


Despite smaller artefacts and larger remnants at @ 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 @ nights of total sleep deprivation ( or rested control ) , and following @ 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 ( @-@ y of age ; @ women ) .


Thirteen subjects were randomized to a @-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 @-year survival .


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


Transcatheter arterial chemoembolisation was repeated ` on-demand ' .


We enrolled @ patients : @ underwent DEB-TACE and @ cTACE .


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


No differences were found in local and overall tumour response .


The median TTP was @ 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 < @ ) .


The @ - and @-year survival rates were @ % and @ % after DEB-TACE and @ % and @ % after cTACE ( P = @ ) .


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


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 = @ ) ages @-@ 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 @ - , @ - , @ - , and @-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 @ healthy volunteers ( NCT@ ) .


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


Blood samples were obtained before , @ min after and @ 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 .


@F-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 @ patients ( mean age , @ @ years ; women , @ % ) .


Images were analyzed for the presence of an MCI-like hypometabolic pattern using an SVA by @ physicians and a voxel-based statistical procedure ( statistical parametric mapping -LSB- SPM -RSB- ) that compared each patient 's images to normal reference samples from @ 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 @ patients ( @ % ) by SVA and @ patients ( @ % ) by SPM analysis ; however , only @ of these patients were selected by both methods .


The group characteristics of the @ patients identified by the quantitative method were consistent with the MCI pattern , which included a higher rate of abnormal GB-FCSRT in Free Recall ( @ % vs. @ % , p < @ ) or in Total Recall ( @ % vs. @ % , p < @ ) 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 , @ cases of impared fasting glucose ( IFG ) Chinese Han population from the age of @ to @ years old , were screened from @ community health centers of three main districts of Nanjing city by the multi-stage cluster and simple randomization method from March to September , @ .


The IFG subjects were randomly divided into the intervention group ( @ individuals ) and control group ( @ 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 @ ( LCN-@ ) 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 ( ( @ @ ) kg/m ( @ ) ) , FBG ( ( @ @ ) mmol/L ) , FINS ( ( @ @ ) mU/L ) , HOMA-IR ( @ @ ) , leptin ( ( @ @ ) g / L ) , LCN-@ ( ( @ @ ) g/L ) of intervention group were decreased significantly compared to the levels of BMI ( ( @ @ ) kg/m ( @ ) ) , FBG ( ( @ @ ) mmol/L ) , FINS ( ( @ @ ) mU/L ) , HOMA-IR ( @ @ ) , leptin ( ( @ @ ) g/L ) , LCN-@ ( ( @ @ ) g/L ) before dietary intervention , t values were @ , @ , @ , @ , @ and @ , respectively , and all P values were < @ , while ADP ( ( @ @ ) mg/L ) of intervention group after dietary intervention was increased significantly compared to the level of ADP ( ( @ @ ) mg/L ) before dietary intervention , t = -@ and P < @ .


The medians ( P@ , P @ ) of differences after and before dietary intervention in the intervention group were BMI ( -@ ( -@ , @ ) kg/m ( @ ) ) , FBG ( -@ ( -@ , @ ) mmol/L ) , FINS ( -@ ( -@ , @ ) mU/L ) , HOMA-IR ( -@ ( -@ , -@ ) ) , leptin ( -@ ( -@ , @ ) g/L ) , LCN-@ ( -@ ( -@ , -@ ) g/L ) and ADP ( @ ( -@ , @ ) mg/L ) , and the medians of differences of after and before dietary intervention in the control group were BMI ( @ ( -@ , @ ) kg/m ( @ ) ) , FBG ( @ ( -@ , @ ) mmol/L ) , FINS ( -@ ( -@ , @ ) mU/L ) , HOMA-IR ( -@ ( -@ , @ ) ) , leptin ( -@ ( -@ , @ ) g/L ) , LCN-@ ( -@ ( -@ , @ ) g/L ) and ADP ( @ ( -@ , @ ) mg/L ) .


There were significantly statistical differences between them ( Z values were -@ , -@ , -@ , -@ , -@ , -@ and @ , all P values were < @ ) .


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 @ community volunteers with hip pain levels of @ or higher on a visual analog scale of @ mm ( range , @-@ mm ; @ indicates worst pain possible ) and hip osteoarthritis confirmed by radiograph .


Forty-nine patients in the active group and @ in the sham group underwent @ weeks of intervention and @ weeks of follow-up ( May @-February @ ) INTERVENTIONS : Participants attended @ treatment sessions over @ 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 @ weeks after treatment , the active group continued unsupervised home exercise while the sham group self-applied gel @ times weekly .


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


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


Ninety-six patients ( @ % ) completed week @ measurements and @ ( @ % ) completed week @ 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 @ mm ( @ ) and the week-@ score was @ mm ( @ ) ; for the sham group , the baseline score was @ mm ( @ ) and the week-@ score was @ mm ( @ ) .


The mean difference was @ mm favoring sham treatment ( @ % CI , -@ to @ ) .


The function scores were not significantly different between groups .


The baseline mean ( SD ) physical function score for the active group was @ ( @ ) and the week-@ score was @ ( @ ) units , whereas the baseline score for the sham treatment group was @ ( @ ) units and the week-@ score was @ ( @ ) units , for a mean difference of @ units favoring sham ( @ % CI , -@ to @ ) at week @ .


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


Nineteen of @ patients ( @ % ) in the active group reported @ mild adverse effects and @ of @ ( @ % ) in the sham group reported @ mild adverse events ( P = @ ) .


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 .


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 @-month quasi-experimental trial of a QI program in @ nursing homes ( @ comparison , @ intervention ) conducted from March to November @ .


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 @,@ 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 = @ , @ % confidence interval = @-@ @ ) .


Based on baseline prescribing rates of @ prescriptions per @,@ resident-days , this estimated adjusted incidence rate ratio implies @ prescriptions avoided per @,@ 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 @-@ at Imam Reza Hospital , Mashhad , Iran .


One hundred patients with Benign Prostatic Hyperplasia were randomly divided into @ 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 , @ and @ months after the medication .


The data was analysed using SPSS @ 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 @ months after the treatment in both groups , specially in group @ @ vs @ ( @ % versus @ % ) .


Quality of life was better in group @ , @ vs @ ( @ % versus @ % ) .


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 @ Gy with either IG-IMRT or @D-CRT .


Patients treated with @D-CRT ( n = @ ) and IG-IMRT ( n = @ ) receiving @ Gy in @ fractions within @ 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 @ and @ and at @ days after treatment .


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


Univariate and multivariate binary logistic regression analyses were applied .


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


The mean dose to the anorectum was @ Gy versus @ Gy ( P < @ ) , @ Gy versus @ Gy for the anal canal ( P < @ ) , and @ Gy versus @ Gy for the bladder ( P < @ ) .


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


IG-IMRT resulted in significantly lower overall RTOG grade @ GI toxicity ( @ % vs @ % , respectively , P = @ ) and overall GU grade @ toxicity ( @ % vs @ % , respectively , P = @ ) .


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 @ 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 @ months of follow-up and data for @ 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 = @ ) according to multivariate logistic regression analysis .


A cutoff value of @ resulted in sensitivity of @ % and specificity of @ % for predicting future PL .


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


( @/@ vs. @/@ ; ( @ ) = @ ; P = @ ) .


Among patients with an initial NGGA > @ , those who accepted early hyaluronic acid injection had a significantly lower rate of PL ( @/@ vs. @/@ ; ( @ ) = @ ; P = @ ) 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 @ participants in the Supplmentation en Vitamines et Minraux Antioxydants ( SU.VI.MAX ) cohort ( follow-up : @-@ ) who completed at least six @-h dietary records during the first @ 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 @ y , @ incident skin cancers were diagnosed .


Dietary folate intake was associated with increased risk of overall skin cancer -LSB- HR for tertile @ compared with tertile @ ( HR ( T@vs.T@ ) ) : @ ; @ % CI : @ , @ ; P-trend = @ -RSB- , NMSC ( HR ( T@vs.T@ ) : @ ; @ % CI : @ , @ ; P-trend = @ ) , and BCC ( HR ( T@vs.T@ ) : @ ; @ , @ ; P-trend = @ ) .


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


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


Erythrocyte folate concentration was directly associated with increased risk of overall skin cancer ( HR ( T@vs.T@ ) : @ ; @ % CI : @ , @ ; P-trend = @ ) , NMSC ( HR ( T@vs.T@ ) : @ ; @ % CI : @ , @ ; P-trend = @ ) , and BCC ( HR ( T@vs.T@ ) : @ ; @ % CI : @ , @ ; P-trend = @ ) ( 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 @ 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 AZD@ , 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 @ years old or older with severe sepsis and/or septic shock .


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


Patients were randomized @:@:@ to a single loading infusion of AZD@ @ U/kg followed by @ U/kg every @ hours ( low dose , n = @ ) , a single loading infusion of AZD@ @ U/kg followed by @ U/kg every @ hours ( high dose , n = @ ) , or placebo ( n = @ ) for @ days .


Follow-up assessments were performed up to day @ .


Mean number of ventilator-free days ( primary endpoint ) did not differ between low-dose ( @ d ) or high-dose AZD@ ( @ d ) and placebo ( @ d ) ( one-sided p = @ and @ , respectively ) .


Mortality rates were comparable across treatment groups ; relative risk of death versus placebo at day @ was @ for low-dose AZD@ ( one-sided p = @ ) and @ for high-dose AZD@ ( p = @ ) .


Most patients experienced at least one treatment-emergent adverse event ( @ % in AZD@-treated patients , @ % 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 .


AZD@ 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 @-@ 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 @ of the study .


Then in phase @ , 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 @ till plateau was achieved and then for @ months in phase @ .


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


In phase @ , 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 @ 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 @ , 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 @ years in women aged @-@ 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 .


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


@,@ women , aged @-@ , randomly assigned to mammography ( five annual mammography screens ) or control ( no mammography ) .


Women aged @-@ in the mammography arm and all women aged @-@ in both arms received annual physical breast examinations .


Women aged @-@ 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 , @ invasive breast cancers were diagnosed in the mammography arm ( n = @,@ participants ) and @ in the controls ( n = @,@ ) , and of these , @ women in the mammography arm and @ women in the control arm died of breast cancer during the @ year follow-up period .


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


The findings for women aged @-@ and @-@ were almost identical .


During the entire study period , @ women in the mammography arm and @ in the control arm had a diagnosis of breast cancer , and @ and @ , 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 @ , @ % confidence interval @ to @ ) .


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


Annual mammography in women aged @-@ 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 , @ % ( @/@ ) of screen detected invasive breast cancers were over-diagnosed , representing one over-diagnosed breast cancer for every @ 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 @ children between the ages of @ and @ 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 @ 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 .


( @ ) 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 .


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


In two of three phase @ 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 @ study , we randomly assigned @ patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone ( @ mg per day ) or placebo for @ weeks .


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


Secondary end points were the @-minute walk distance , progression-free survival , dyspnea , and death from any cause or from idiopathic pulmonary fibrosis .


In the pirfenidone group , as compared with the placebo group , there was a relative reduction of @ % in the proportion of patients who had an absolute decline of @ percentage points or more in the percentage of the predicted FVC or who died ; there was also a relative increase of @ % in the proportion of patients with no decline in FVC ( P < @ ) .


Pirfenidone reduced the decline in the @-minute walk distance ( P = @ ) and improved progression-free survival ( P < @ ) .


There was no significant between-group difference in dyspnea scores ( P = @ ) or in rates of death from any cause ( P = @ ) or from idiopathic pulmonary fibrosis ( P = @ ) .


However , in a prespecified pooled analysis incorporating results from two previous phase @ trials , the between-group difference favoring pirfenidone was significant for death from any cause ( P = @ ) and from idiopathic pulmonary fibrosis ( P = @ ) .


Gastrointestinal and skin-related adverse events were more common in the pirfenidone group than in the placebo group but rarely led to treatment discontinuation .


Pirfenidone , as compared with placebo , reduced disease progression , as reflected by lung function , exercise tolerance , and progression-free survival , in patients with idiopathic pulmonary fibrosis .


Treatment was associated with an acceptable side-effect profile and fewer deaths .


( Funded by InterMune ; ASCEND ClinicalTrials.gov number , NCT@ . )


This study examined the effects of preoperative incentive spirometry ( IS ) education ( POISE ) on postoperative outcomes for knee and hip total joint replacement patients .


In this prospective study , @ patients were randomized to Group @ ( POISE intervention = @ completing ) or Group @ ( no intervention = @ completing ) ( @ dropped ) .


The Group @ intervention consisted of formal instruction preoperatively for IS home use , postoperative use , and IS volumes documentation .


Group @ patients received no intervention .


Patients recorded postoperative IS volumes , which were used to determine return to baseline volume .


One hundred six patients completed the study .


Most were Caucasian females averaging @ years .


Although IS return to baseline volume time was not significantly different between groups , POISE patients had fewer postoperative complications , hospital days , and charges .


POISE patients ranked the intervention as helpful .


Although IS volumes were not significantly different between groups , POISE patients had better outcomes and ranked the intervention as helpful .


Acute pancreatitis is a severe condition that requires early identification of patients at risk of developing potentially lethal complications .


Current clinical scoring systems and biochemical parameters are insufficient .


In this study , we aimed to assess whether early plasma Angiopoietin-@ ( Ang-@ ) is associated with adverse outcomes in patients with predicted severe acute pancreatitis ( SAP ) .


This analysis is a substudy of the PROPATRIA trial ( probiotics vs placebo in patients with predicted SAP ) .


The Ang-@ levels were measured prospectively in plasma in the first @ days after admission in @ patients .


Early Ang-@ levels were higher in patients who developed SAP : @ vs @ g/L ( p < @ ) and also were higher in patients who developed multiorgan failure in the first week ( p = @ ) and after the first week ( p = @ ) .


Furthermore , high Ang-@ levels were associated with infectious complications in the first week ( p < @ ) and after the first week ( p < @ ) .


Finally , plasma Ang-@ was significantly higher in patients who died ( p < @ ) and in patients who developed bowel ischemia ( p < @ ) .


As a predictor of adverse outcomes , plasma Ang-@ was superior to a number of current scores , such as the APACHE II score , the Imrie score , C-reactive protein , lipopolysaccharide binding protein , and procalcitonin .


In the setting of this randomized controlled trial , early plasma Ang-@ was found to be an accurate predictor of SAP , multiorgan failure , and infectious complications .


As a biomarker , it did outperform all of the investigated conventional predictors that are currently used in clinical practice .


To evaluate the interleukin-@ receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis ( pcJIA ) .


This three-part , randomised , placebo-controlled , double-blind withdrawal study ( NCT@ ) included patients who had active pcJIA for @months and inadequate responses to methotrexate .


During part @ , patients received open-label tocilizumab every @weeks ( @ or @mg/kg for body weight ( BW ) < @kg ; @mg/kg for BW @kg ) .


At week @ , patients with JIA-American College of Rheumatology ( ACR ) @ improvement entered the @-week , double-blind part @ after randomisation @:@ to placebo or tocilizumab ( stratified by methotrexate and steroid background therapy ) for evaluation of the primary end point : JIA flare , compared with week @ .


Patients flaring or completing part @ received open-label tocilizumab .


In part @ , @ patients received tocilizumab ( < @kg : @mg/kg ( n = @ ) or @mg/kg ( n = @ ) ; @kg : n = @ ) .


In part @ , @ patients received tocilizumab ( n = @ ) or placebo ( n = @ ) .


JIA flare occurred in @ % of patients on placebo versus @ % continuing tocilizumab ( difference in means adjusted for stratification : -@ ; @ % CI -@ to -@ ; p = @ ) .


At the end of part @ , @ % and @ % of patients receiving tocilizumab had JIA-ACR@ and JIA-ACR@ responses , respectively .


Rates/@ patient-years ( PY ) of adverse events ( AEs ) and serious AEs ( SAEs ) were @ and @ , respectively ; infections were the most common SAE ( @ / @ PY ) .


Tocilizumab treatment results in significant improvement , maintained over time , of pcJIA signs and symptoms and has a safety profile consistent with that for adults with rheumatoid arthritis .


Postprandial triglyceride ( TG ) concentration is independently associated with cardiovascular disease risk .


Exercise reduces postprandial TG concentrations , but the mechanisms responsible are unclear .


The objective was to determine the effects of exercise on affinity of chylomicrons , large very low-density lipoproteins ( VLDL@ ) , and smaller VLDL ( VLDL@ ) for lipoprotein lipase ( LPL ) - mediated TG hydrolysis .


This was designed as a within-participant crossover study .


The setting was a university metabolic investigation unit .


Participants were @ overweight/obese men .


Participants undertook two oral fat tolerance tests , separated by @-@ days , in which they had blood taken while fasting and for @ hours after a high-fat mixed meal .


On the afternoon before one test , they performed a @-minute treadmill walk at @ % maximal oxygen uptake ( exercise trial -LSB- EX -RSB- ) ; no exercise was performed before the control trial ( CON ) .


We measured circulating TG-rich lipoprotein concentrations and affinity of chylomicrons , VLDL@ , and VLDL@ for LPL-mediated TG hydrolysis .


Exercise significantly reduced fasting VLDL@-TG concentration ( CON , @ -LSB- @-@ @ -RSB- mmol.L ( -@ ) ; EX , @ -LSB- @-@ @ -RSB- mmol.L ( -@ ) ; geometric means -LSB- @ % confidence interval -RSB- ; P = @ ) .


Time-averaged postprandial chylomicron-TG ( CON , @ @ mmol.L ( -@ ) ; EX , @ @ mmol.L ( -@ ) ; mean SEM ; P = @ ) and VLDL@-TG ( CON , @ @ mmol.L ( -@ ) ; EX , @ @ mmol.L ( -@ ) ; P = @ ) concentrations were both lower in EX than CON .


Affinity of VLDL@ for LPL-mediated TG hydrolysis increased by @ ( @-@ @ ) - fold -LSB- geometric mean ( @ % confidence interval ) -RSB- ( P = @ ) in the fasted state and @ ( @-@ @ ) - fold ( P = @ ) postprandially .