The addition of chicken and vegetable resulted in a GI value of @ and @ , respectively .


The insulinaemic index ( II ) of the white rice-based meals varied between @ and @ .


Chicken breast in the meal increased the insulinaemic response and decreased the GR .


White rice II was lower than the glucose control , which indicated that the former was not as insulinogenic as the latter .


White rice with vegetable had the lowest II .


Co-ingesting chicken , oil or vegetable with white rice considerably influences its glycaemic and insulinaemic responses .


Co-ingesting white rice with all three components attenuates the GR to a greater degree than when it is eaten with any single one of them , and that this is not at the cost of an increased demand for insulin .


Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian ( PA ) populations .


The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk ( CRUCIAL ) trial demonstrated that a proactive multifactorial intervention ( PMI ) approach ( based on single-pill amlodipine/atorvastatin ) resulted in a greater reduction in calculated Framingham @-year coronary heart disease ( CHD ) risk compared with usual care ( UC ) among hypertensive patients with additional risk factors .


One-third of CRUCIAL patients resided in the PA region .


The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management ( PMI versus UC ) among patients residing in PA and non-PA regions .


This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions .


Sensitivity analyses were conducted among men and women and those with and without diabetes .


Overall , @ patients ( @ % ) resided in the PA region and @ patients ( @ % ) resided in non-PA regions .


The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA ( -@ % versus -@ % ; P < @ ) and non-PA regions ( -@ % versus -@ % ; P < @ ) ; region interaction P = @ .


PA patients had slightly greater reductions in total cholesterol compared with non-PA patients .


PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients .


Treatment effects were similar in men and women and those with diabetes .


The PMI approach was more effective in reducing calculated Framingham @-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region .


Evidences from cultured cells and animal models of ischemia suggest that lithium has neuroprotective and neurotrophic effects and may play a desirable role in reducing infarct volume and even improving the brain insults from stroke .


The aim of this study was to evaluate the efficacy of lithium in early motor recovery of patients after ischemic stroke .


Eighty patients with first ever stroke , allocated randomly in lithium , @ mg twice daily , or placebo .


Treatment was initiated @ hours after stroke and continued for @ days .


Modified National Institute of Health Stroke Scale ( mNIHSS ) and hand subsection of Fugl-Meyer Assessment ( hFMA ) were used to evaluate impairment on the fifth and @th day of treatment .


Sixty-six subjects ( @ subjects in the lithium group and @ subjects in the placebo group ) completed the study .


There were no significant differences in the improvement in mNIHSS ( P = @ ) and hFMA ( P = @ ) after @ days .


However , a subgroup analysis showed that patients with cortical strokes in the lithium group had significantly better improvement in both mNIHSS and hFMA in comparison to the placebo group ( P = @ ) .


Approximately @ % ( n = @ ) of patients in the lithium group , mainly from the cortical stroke subgroup , regained more than @ % of full function based on hFMA , whereas this rate in the placebo group was @ % ( n = @ ; P = @ ) .


The observed discrete difference between the lithium group and the placebo group in the cortical stroke subgroup may suggest an enhanced motor recovery after stroke by using an early treatment with a low dose of lithium carbonate .


However , a larger trial with more patients with cortical stroke is needed to investigate this effect better .


Fitzpatrick 's classification is the most common way of assessing skin UV sensitivity .


The study aim was to investigate how self-estimated and actual UV sensitivity , as measured by phototest , are associated with attitudes towards sunbathing and the propensity to increase sun protection , as well as the correlation between self-estimated and actual UV sensitivity .


A total of @ primary healthcare patients filled-out a questionnaire investigating attitudes towards sunbathing and the propensity to increase sun protection .


They reported their skin type according to Fitzpatrick , and a UV sensitivity phototest was performed .


Self-rated low UV sensitivity ( skin type III-VI ) was associated with a more positive attitude towards sunbathing and a lower propensity to increase sun protection , compared to high UV sensitivity .


The correlation between the two methods was weak .


The findings might indicate that individuals with a perceived low but in reality high UV sensitivity do not seek adequate sun protection with regard to skin cancer risk .


Furthermore , the poor correlation between self-reported and actual UV sensitivity , measured by phototest , makes the clinical use of Fitzpatrick 's classification questionable .


Intracerebral hemorrhage causes @ % of strokes annually in the United States , and there is currently no effective therapy .


This is a clinical trial designed to study the safety , feasibility , and efficacy of a protocol of targeted temperature management to moderate hypothermia in intracerebral hemorrhage patients .


The targeted temperature management after intracerebral hemorrhage trial is a prospective , single-center , interventional , randomized , parallel , two-arm ( @:@ ) phase-II clinical trial with blinded end-point ascertainment .


Intracerebral hemorrhage patients will be randomized within @h of symptom onset to either @h of targeted temperature management to moderate hypothermia ( @-@C ) followed by a controlled rewarming at of @-@C per hour or @h of targeted temperature management to normothermia ( @-@C ) using endovascular or surface cooling .


The primary outcome is the development of serious adverse events possibly and probably related to treatment .


Secondary outcomes include in-hospital neurological deterioration between day @-@ , in-hospital mortality , functional outcome measured by the modified Rankin scale at discharge and @ days , and effect of treatment allocation on cerebral edema and hematoma volume .


Intracerebral hemorrhage remains the most severe form of stroke with limited options to improve survival .


As the early resuscitation phase in the intensive care unit represents the greatest opportunity for impact on clinical outcome , it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating aggressive treatments .


More research of novel therapies to improve outcomes after intracerebral hemorrhage is desperately needed .


The results of the targeted temperature management after intracerebral hemorrhage clinical trial may provide additional information on the applicability of targeted temperature management after intracerebral hemorrhage .


The debate about whether energy consumed in liquid form is more obesogenic than energy consumed in solid form remains equivocal .


We aimed to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in childhood adiposity .


Our analyses included @-year-old Australian children ( n = @ ) participating in the Childhood Asthma Prevention Study .


Dietary information was collected using three @-h recalls at age @ years .


Multivariate linear regression was used to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in body mass index ( BMI ) Z-score from ages @ to @ years ( BMIz ( @-@ @ y ) ) and percentage body fat ( % BF ) at age @ years ( % BF ( @ y ) ) .


Substitution models were used to evaluate the effects of substituting other beverage types for sugar-sweetened beverages ( SSB ) .


Liquid energy intake ( @ MJ day ( -@ ) ) was more closely associated with both BMIz ( @-@ @ y ) ( = @ , P = @ ) and % BF ( @ y ) ( = @ % , P = @ ) than solid energy intake ( BMIz ( @-@ @ y ) : = @ , P = @ and % BF ( @ y ) : = @ % , P = @ ) .


SSB consumption ( @ g day ( -@ ) ) was directly associated with BMIz ( @-@ @ y ) ( = @ , P = @ ) and % BF ( @ y ) ( = @ % , P = @ ) , whereas diet drinks ( @ g day ( -@ ) ) were inversely associated with BMIz ( @-@ @ y ) ( = @ , P = @ ) .


Substitution of @ g of SSB by @ g of water or diet drink , but not other beverages , was inversely associated with both BMIz ( @-@ @ y ) and % BF ( @ y ) ( P < @ ) .


Our findings indicate that liquid energy is more obesogenic than solid energy .


In particular , SSB , but not other beverage types , are a significant predictor of childhood adiposity and replacing SSB with water can have long-term beneficial effects on childhood adiposity .


- blockers are the standard treatment for myocardial infarction ( MI ) based on evidence from the pre-thrombolytic era .


The aim of this study was to examine the effect of - blocker treatment in patients with acute MI and preserved systolic function in the era of percutaneous coronary intervention ( PCI ) .


We analysed a multicentre registry and identified @ patients who presented with acute MI between @ and @ .


Patients were treated with PCI , had left ventricular EFs @ % according to echocardiograms that were performed during the index PCI , and were alive at the time of discharge .


The association between - blocker use after discharge and mortality ( all-cause death and cardiac death ) within @ years was examined .


Patients who were not treated with - blockers ( n = @ ) showed higher rates of all-cause death and cardiac death compared to patients treated with - blockers ( @ % vs @ % , p < @ , @ % vs @ % , p < @ ) .


The multivariate Cox proportional hazards model showed that - blocker treatment was associated with a significant reduction in all-cause death ( adjusted HR @ , @ % CI @ to @ ; p = @ ) and cardiac death ( adjusted HR @ , @ % CI @ to @ ; p < @ ) .


Comparable results were obtained after propensity score matching .


- blocker treatment was associated with reduced long term mortality in patients with acute MI and preserved systolic function who received PCI .


We have found that hydrogen ( dihydrogen -LSB- H@ -RSB- ) decreases plasma low-density lipoprotein ( LDL ) cholesterol levels and improves high-density lipoprotein ( HDL ) function in patients with potential metabolic syndrome in a before-after self-controlled study .


The purpose of this study was to further characterize the effects of H@-rich water ( @ L/day ) on the content , composition , and biological activities of plasma lipoproteins on patients with hypercholesterolemia and their underlying mechanisms in a double-blinded , randomized , and placebo-controlled trial .


This was a case-control study .


The setting was the Zhoudian community , Tai'an , China .


A total of @ patients with untreated isolated hypercholesterolemia were randomly allocated to either drinking H@-rich water ( n = @ ) or placebo water ( n = @ ) for @ weeks .


HDL isolated from the H@ group showed an increased ability to promote the ATP-binding cassette transporter A@-mediated cholesterol efflux ex vivo .


Plasma pre -- HDL levels were up-regulated although there were no changes in plasma HDL-cholesterol levels .


Moreover , other HDL functions , assessed in protection against LDL oxidation , inhibition of oxidized-LDL-induced inflammation , and protection of endothelial cells from oxidized-LDL-induced apoptosis , were all significantly improved by H@ treatment .


In addition , H@ treatment increased the effective rate in down-regulating plasma levels of total cholesterol ( @ % vs @ % ) and LDL cholesterol ( @ % vs @ % ) .


Western blot analysis revealed a marked decrease in apolipoprotein B@ and an increase in apolipoprotein M in plasma of the H@ group .


Finally H@ treatment resulted in a significant reduction in the levels of several inflammatory and oxidative stress indicators in whole plasma and HDL particles .


H@ activates ATP-binding cassette transporter A@-dependent efflux , enhances HDL antiatherosclerotic functions , and has beneficial lipid-lowering effects .


The present findings highlight the potential role of H@ in the regression of hypercholesterolemia and atherosclerosis .


Persistent muscle weakness after anterior cruciate ligament ( ACL ) reconstruction may be due to underlying activation failure and arthrogenic muscle inhibition ( AMI ) .


Knee-joint cryotherapy has been shown to improve quadriceps function transiently in those with AMI , thereby providing an opportunity to improve quadriceps muscle activation and strength in patients with a reconstructed ACL .


To compare quadriceps muscle function in patients with a reconstructed ACL who completed a @-week intervention including daily cryotherapy ( ice bag ) , daily exercises , or both .


Cross-sectional study .


Laboratory .


A total of @ patients with reconstructed ACLs who were at least @ months post-index surgery and had measurable quadriceps AMI .


The patients attended @ supervised visits over a @-week period .


They were randomly assigned to receive @ minutes of knee-joint cryotherapy , @ hour of therapeutic rehabilitation exercises , or cryotherapy followed by exercises .


We measured quadriceps Hoffmann reflex , normalized maximal voluntary isometric contraction torque , central activation ratio using the superimposed-burst technique , and patient-reported outcomes before and after the intervention period .


After the @-week intervention period , patients who performed rehabilitation exercises immediately after cryotherapy had higher normalized maximal voluntary isometric contraction torques ( P = @ , Cohen d effect size = @ ) compared with those who received cryotherapy alone ( P = @ , d = @ ) or performed exercise alone ( P = @ , d = @ ) .


After ACL reconstruction , patients with AMI who performed rehabilitation exercises immediately after cryotherapy experienced greater strength gains than those who performed cryotherapy or exercises alone .


Organ dysfunction consequent to infection ( ` severe sepsis ' ) is the leading cause of admission to an intensive care unit ( ICU ) .


In both animal models and early clinical studies the calcium channel sensitizer levosimendan has been demonstrated to have potentially beneficial effects on organ function .


The aims of the Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis ( LeoPARDS ) trial are to identify whether a @-hour infusion of levosimendan will improve organ dysfunction in adults who have septic shock and to establish the safety profile of levosimendan in this group of patients .


This is a multicenter , randomized , double-blind , parallel group , placebo-controlled trial .


Adults fulfilling the criteria for systemic inflammatory response syndrome due to infection , and requiring vasopressor therapy , will be eligible for inclusion in the trial .


Within @ hours of meeting these inclusion criteria , patients will be randomized in a @:@ ratio stratified by the ICU to receive either levosimendan ( @ to @ g.kg.min or placebo for @ hours in addition to standard care .


The primary outcome measure is the mean Sequential Organ Failure Assessment ( SOFA ) score while in the ICU .


Secondary outcomes include : central venous oxygen saturations and cardiac output ; incidence and severity of renal failure using the Acute Kidney Injury Network criteria ; duration of renal replacement therapy ; serum bilirubin ; time to liberation from mechanical ventilation ; @-day , hospital , @ and @ month survival ; ICU and hospital length-of-stay ; and days free from catecholamine therapy .


Blood and urine samples will be collected on the day of inclusion , at @ hours , and on days @ and @ post-inclusion for investigation of the mechanisms by which levosimendan might improve organ function .


Eighty patients will have additional blood samples taken to measure levels of levosimendan and its active metabolites OR-@ and OR-@ .


A total of @ patients will be recruited from approximately @ ICUs in the United Kingdom .


This trial will test the efficacy of levosimendan to reduce acute organ dysfunction in adult patients who have septic shock and evaluate its biological mechanisms of action .


To assess the efficacy and safety of Wuji Powder ( WP ) and a small dose aripiprazole in treatment of antipsychotic drug-induced phlegm dampness type amenorrhea .


Seventy female schizophrenic patients with antipsychotic drug-induced galactorrhea-amenorrhea syndrome ( GAS ) were recruited and randomly assigned to the treatment group and the control group , @ in each group .


All patients received antipsychotic drug therapy .


Patients in the treatment group additionally took WP , while those in the control group took aripiprazole ( at the daily dose of @ mg , once daily ) .


The therapeutic course for all was @ weeks .


Prolactin levels and obesity indices -LSB- body weight , waist aircumstance , body mass index ( BMI ) and waist-hit ratio ( WHR ) -RSB- were determined before and after treatment .


The efficacy was evaluated .


The treatment course was completed in @ % of patients .


The total effective rate of the @ patients of the treatment group was @ % ( @/@ ) , while it was @ % ( @/@ ) in the @ patients of the control group .


There was no difference in the total effective rate between the two groups ( P > @ ) .


Prolactin levels in both group after treatment were significantly lower than those of the baseline ( P < @ ) .


There was no significant difference in prolactin levels between the two groups after treatment ( P > @ ) .


Compared with before treatment , body weight , BMI , waist circumstance , and waist-hip ratio obviously decreased after treatment , showing significant difference when compared with the control group ( P < @ ) .


There was no significant difference in body weight , BMI , waist circumstance , and waist-hip ratio in the control group between before and after treatment ( P > @ ) .


Both WP and aripiprazole could lower high prolactin levels of schizophrenics with phlegm dampness type amenorrhea .


They showed equivalent efficacy .


But WP showed more obvious effect in reducing obesity indices .


The long-term efficacy and safety of canagliflozin , a sodium glucose co-transporter @ inhibitor , was evaluated over @weeks in patients aged @-@years with type @ diabetes mellitus ( T@DM ) inadequately controlled on a stable antihyperglycaemic agent regimen .


In this randomized , double-blind , phase III study , patients received canagliflozin @ or @mg or placebo once daily during a @-week core period ( N = @ ) and a @-week extension period ( n = @ ) .


Efficacy endpoints at week @ included change from baseline in glycated haemoglobin ( HbA@c ) , fasting plasma glucose ( FPG ) and systolic blood pressure , and percent change from baseline in body weight and fasting plasma lipids .


Safety was assessed by adverse event ( AE ) reports .


At week @ , canagliflozin @ and @mg were associated with reductions in HbA@c versus placebo ( -@ and -@ % vs @ % , respectively ; overall mean baseline , @ % ) and more patients achieved HbA@c < @ % with canagliflozin @ and @mg than with placebo ( @ and @ % vs @ % , respectively ) .


Reductions in FPG , body weight and systolic blood pressure , and increases in high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol ( LDL-C ) were seen with canagliflozin compared with placebo .


The overall incidence rates of AEs over @weeks were @ , @ and @ % with canagliflozin @ and @mg and placebo , respectively ; serious AE rates were low across treatment groups .


The incidence rates of urinary tract infections , genital mycotic infections and osmotic diuresis - and volume depletion-related AEs were higher with canagliflozin than with placebo .


Canagliflozin improved glycaemic control , reduced body weight and systolic blood pressure , and was generally well tolerated in patients aged @-@years with T@DM over @weeks .


Thalidomide use in cutaneous sarcoidosis is based on data from small case series or case reports .


The objective of this study was to evaluate the efficacy and safety of thalidomide in severe cutaneous sarcoidosis .


This study consisted of a randomized , double-bind , parallel , placebo-controlled , investigator-masked , multicenter trial lasting @ months and an open-label study from month @ to month @ .


Adults with a clinical and histologic diagnosis of cutaneous sarcoidosis were included in nine hospital centers in France .


Patients were randomized @:@ to oral thalidomide ( @ mg once daily ) or to a matching oral placebo for @ months .


In the course of an open-label follow-up from month @ to month @ , all patients received thalidomide , @ mg to @ mg daily .


The proportions of patients with a partial or complete cutaneous response at month @ , based on at least a @ % improvement in three target lesions scored for area and infiltration , were compared across randomization groups .


The intent-to-treat population included @ patients .


None of them had a complete cutaneous response .


Four out of @ patients in the thalidomide group ( @ % ) vs four out of @ patients in the placebo group ( @ % ) had a partial cutaneous response at month @ ( difference in proportion of -@ % -LSB- @ % CI , -@ % to +@ % -RSB- for thalidomide vs placebo , P = @ ) .


Eight patients with side effects were recorded in the thalidomide group vs three in the placebo group .


We observed a large number of adverse event-related discontinuations in patients taking thalidomide in the first @ months ( four patients with thalidomide , zero with placebo ) and in the @ following months ( five patients ) .


At a dose of @ mg daily for @ months , our results do not encourage thalidomide use in cutaneous sarcoidosis .


To assess whether medical record documentation reflects actual home practices regarding the administration of preventive medications to urban children with persistent asthma .


Baseline data from a prompting asthma intervention were used for this cross-sectional analysis .


As part of the larger study , we enrolled children ( @-@ years ) with persistent asthma in the waiting room at @ primary care offices ( @-@ ) .


Prior to their visit with a healthcare provider , caregivers reported information regarding their child 's asthma symptom severity and current preventive medications ( i.e. name and frequency of use ) .


We compared caregiver-reported medication information with medical record data to determine the rate of complete concordance , defined as total consistency between the prescribed medication data documented in the medical record and parent report describing how the child is actually using the medication at home .


According to @ completed medical record reviews , @ ( @ % ) children had a current prescription for a daily preventive asthma medication .


Of these children , @ ( @ % ) had caregivers who reported complete concordance .


Those reporting complete concordance were more likely to have children with greater symptom severity , including fewer symptom-free days in the prior two weeks ( @ vs. @ , p = @ ) , and @ asthma-related hospitalization in the prior year ( @ % vs. @ % , p = @ ) .


Medical records may poorly reflect actual home practices and providers should specifically inquire about medication use and barriers to adherence at the time of an office visit to promote guideline-based , consistent treatment for children with persistent asthma .


To determine the pathological mechanism and prevent heart-renal syndrome after heart valve replacement surgery .


A total of @ patients were admitted for selective valve replacement , and divide into @ groups randomly : a control group ( Con , n = @ ) , a remote ischemic perconditioning ( RIPerC ) group ( n = @ ) and a remote ischemic postconditioning ( RIPostC ) group ( n = @ ) .


The serum creatinine ( SCr ) , blood urea nitrogen ( BUN ) , serum heme oxygennase-@ ( HO-@ ) , serum iron and urinary neutrophil gelatinase associated lipocalin ( NGAL ) level in the @ groups were compared preoperatively and @ , @ , @ , @ h after aortic cross-release .


Compared with the preoperative level , the SCr , BUN , urinary NGAL , serum iron ( @ and @ h ) and serum HO-@ values were significantly increased after the heart valve replacement surgery in the control patients , RIPreC and RIPostC groups ( P < @ ) .


Compared with the control group , the serum HO-@ was significantly increased at @ , @ , @ , @ h after the heart valve replacement surgery in both the RIPerC and RIPostC groups ( P < @ ) ; the SCr , BUN , urinary NGAL and serum iron values were decreased at @ , @ , @ , @ h after the heart valve replacement surgery in both the RIPerC and RIPostC groups ( P > @ ) .


Abnormal change in urinary NGAL , serum iron and HO-@ can be used as early warning indicators of acute kidney injury when cardio-renal syndrome occurrs among patients under heart valve replacement surgery .


Remote ischemic conditioning plays a preventive role in the occurrence of cardio-renal syndrome and renal protection .


The autobiographical Implicit Association Test ( aIAT ) is a variant of the Implicit Association Test reportedly capable of detecting an individual 's concealed autobiographical event with very high accuracy .


A previous attempt to utilize this measurement technique for the identification of cocaine users rendered an alarming rate of false positives .


In this study , we aimed to explore the potential reasons behind the measurement 's inaccuracy .


Two versions of the cocaine aIAT were devised with different category labels ( descriptive ` guilty/innocent ' and self-referenced ` as if you were/were not ' ) .


Forty-one cocaine abstinent participants ( @ % male ; mean age = @ @ ) were randomly assigned to one of the two conditions .


Self-declared cocaine abstinence was confirmed for the @-month period preceding data collection through hair analysis .


Participants were also administered bespoke implicit and explicit cocaine user attitude measures , the self-esteem IAT and the Rosenberg self-esteem scale .


The category labels which elicited self-referenced knowledge showed low accuracy ( @ % ) compared to the @ % of the ` guilty/innocent ' labels proposed by original authors .


The self-referenced aIAT version significantly correlated with the self-concept measures .


The aIAT outcomes were independent from attitudes toward cocaine users .


Category labels play an influential role in determining the test 's accuracy , demonstrating that participants ' propositional knowledge and self-concept are involved during test performance .


The aIAT does not appear to tap directly into an individual 's implicit memory when relevant memory is not available .


Although the test can not be recommended for detecting drug use , further research should investigate underlying mechanisms and other potentials of the technique .


To prospectively compare the achieved thickness and consistency of LASIK flaps created with a @ - and @-kHz femtosecond laser .


One hundred twenty eyes of @ patients with myopia were treated with LASIK .


One eye had flap created by the Intralase FS @-kHz femtosecond laser ( Abbott Medical Optics , Abbott Park , IL ) and the fellow eye was treated with the IntraLase iFS @-kHz femtosecond laser ( Abbott Medical Optics ) .


Eyes were randomized according to ocular dominance .


Flap morphology and measurements were taken with anterior segment optical coherence tomography ( AS-OCT ) at the @-month postoperative visit .


AS-OCT showed similar regular planar morphologies in both groups .


The mean thickness of the flaps in the FS @ group was significantly higher than that of the iFS @ group ( @ @ m vs @ @ m , P = @ ) .


The mean deviation from targeted flap thickness was not significantly different between the two groups .


The Intralase iFS @-kHz femtosecond laser creates flaps of similar thickness and uniformity to the Intralase FS @-kHz femtosecond laser .


Periprosthetic bone cysts are a known finding after total ankle replacement ( TAR ) .


The significance of cysts is uncertain , but they may threaten the long-term survival of the implant .


The aim of this prospective study was to evaluate the diagnostic accuracy of weight-bearing digital radiography compared with @D weight-bearing multiplanar reconstructed ( MPR ) fluoroscopic imaging when diagnosing periprosthetic bone cysts in patients who have undergone TAR .


Forty-two consecutive patients with a Scandinavian Total Ankle Replacement ( STAR ) were consecutively enrolled and underwent digital radiography and @D MPR imaging in the same session .


All @D MPR images were interpreted in a blinded fashion , specifically with regard to the presence and extent of periprosthetic bone cysts .


Cysts were measured in three planes whenever possible .


Interrater and intrarater reliability was assessed by using Cohen kappa test , and comparisons between the two modalities were performed with the Wilcoxon signed-rank and McNemar tests .


Significantly more cysts were detected on @D MPR ( @ vs @ ) ( p = @ ) , with the mean size of cysts detected by @D MPR significantly larger than that of cysts diagnosed on digital radiography ( @ mm ( @ ) vs @ mm ( @ ) ) ( p < @ ) .


Statistical analysis based on the presence or absence of cysts in individual patients did not show a significant difference between @D MPR and digital radiography ( p = @ ) .


The data imply that cysts are better detected and more accurately measured with @D fluoroscopic MPR imaging compared with digital radiography , which underestimates not only the presence but also the extent of periprosthetic cysts .


Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis ( MHD ) and are linked to excess cardiovascular risk .


This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients .


The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress , systemic inflammation , monocyte function , and blood pressure .


Prospective , randomized , crossover , pilot clinical trial ( NCT@ ) .


The study was conducted from March to October @ in outpatient dialysis facilities in the Seattle metropolitan area .


Twenty-four patients undergoing MHD ( men , @ % ; mean age , @years ) were randomly assigned to receive pomegranate juice or extract during a @-week intervention period .


After a washout period , all patients received the alternative treatment during a second @-week intervention period .


Patients assigned to receive pomegranate juice received @mL of juice before each dialysis session .


Patients assigned to receive pomegranate extract were given @,@ mg of extract daily .


The main outcome measures were safety and tolerability of pomegranate juice and extract .


Additional secondary outcomes assessed included serum lipids , laboratory biomarkers of inflammation ( C-reactive protein and interleukin @ ) and oxidative stress ( plasma F@ isoprostanes and isofurans ) , monocyte cytokine production , and predialysis blood pressure .


Both pomegranate juice and extract were safe and well tolerated by study participants .


Over the study period , neither treatment had a significant effect on lipid profiles , plasma C-reactive protein , interleukin @ , F@-isoprostane or isofuran concentrations , predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production .


Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure .


Lipid-based nutrient supplements ( LNSs ) offer a vehicle to improve children 's diets in low-income countries where complementary foods are typically deficient in essential nutrients .


Sustained acceptability by the intended users is essential for achieving growth-promoting effects .


We aimed to determine the sustained acceptability of LNSs among @ - to @-mo-old children in Malawi .


In the context of a trial testing the growth-promoting effect of different formulations and doses of LNSs , we delivered LNSs to the homes of the children biweekly according to the randomization protocol .


We defined acceptability to include adherence to feeding recommendations and mothers ' experiences of feeding LNSs to their child .


We conducted brief interviews each week with the mothers .


At @ time points we conducted knowledge , attitudes , and practices ( KAP ) interviews .


In addition , we conducted repeated in-depth interviews with a subset of mothers .


Of the @ children who received the LNS intervention , we analyzed adherence data from @ ( @ % ) children and KAP data at @ time points ( child 's age of @ and @ mo ) from @ ( @ % ) of the children .


The mean SD overall adherence ( proportion of days when the study child reportedly consumed LNSs considering only those weeks when the supplement had been successfully delivered to the home ) was @ @ % , and there was no difference between children receiving milk-containing or milk-free LNSs .


There was also no increasing or decreasing trend over time in any of the groups .


Sharing and deviation from other feeding recommendations were common .


Maternal experiences were mostly very positive .


The acceptability of LNS products was good and was sustained for @ mo in this rural Malawian population .


However , sharing of the products with family members and deviation from other feeding recommendations were frequent , which means that individually targeted children were likely to receive less than the intended dose of the LNS .


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


To compare the patients ' compliance with and the efficacy of existing treatments for Helicobacter pylori eradication , including moxifloxacin-based triple therapy , sequential treatment and the standard treatment .


Patients with H.pylori infection were randomly assigned to three therapy groups .


The triple therapy ( MML ) group was given moxifloxacin @mg/day , metronidazole @mg b.i.d. and lansoprazole @mg b.i.d. for @ days .


The sequential treatment ( AL-CML ) group was administrated amoxicillin @g b.i.d. and lansoprazole @mg b.i.d. for the first @ days , followed by clarithromycin @mg b.i.d. , metronidazole @mg b.i.d. and lansoprazole @mg b.i.d. for the second @ days .


The standard treatment ( CAL ) group received amoxicillin @g b.i.d. , clarithromycin @mg b.i.d. and lansoprazole @mg b.i.d. for @ days .


The eradication rates were evaluated by per-protocol ( PP ) analysis and intention-to-treat ( ITT ) analysis .


The eradication rates were @ , @ and @ % by PP analysis and @ , @ and @ % by ITT analysis in the MML , AL-CML and CAL group , respectively , and patients ' compliance rates were @ , @ and @ % , respectively .


There were no significant differences in treatment efficacy and compliance rates in the MML , AL-CML and CAL groups ( P > @ ) .


The present study revealed that standard triple therapy , sequential therapy and moxifloxacin-based triple therapy are all effective treatment regimens in terms of H.pylori eradication rates and compliance with therapy in Turkey .


Treatment of patients with drug-eluting stent ( DES ) in-stent restenosis ( ISR ) remains a major challenge .


This study evaluated the comparative efficacy of drug-eluting balloons ( DEB ) and everolimus-eluting stents ( EES ) in patients presenting with DES-ISR .


The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint , in-segment minimal lumen diameter at the @ - to @-month angiographic follow-up .


A total of @ patients with DES-ISR from @ Spanish university hospitals were randomly allocated to DEB ( n = @ ) or EES ( n = @ ) .


At late angiography ( median @ days ; @ % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( @ @ mm vs. @ @ mm ; p < @ ) ( absolute mean difference : @ mm ; @ % CI : @ to @ ) , net lumen gain ( @ @ mm vs. @ @ mm ; p < @ ) , and lower percent diameter stenosis ( @ @ % vs. @ @ % ; p < @ ) and binary restenosis rate ( @ % vs. @ % ; p = @ ) , compared with patients in the DEB arm .


Consistent results were observed in the in-lesion analysis .


At the @-year clinical follow-up ( @ % of patients ) , the main clinical outcome measure ( composite of cardiac death , myocardial infarction , and target vessel revascularization ) was significantly reduced in the EES arm ( @ % vs. @ % ; p = @ ; hazard ratio : @ ; @ % CI : @ to @ ) , mainly driven by a lower need for target vessel revascularization ( @ % vs. @ % ; p = @ ) .


In patients with DES-ISR , EES provided superior long-term clinical and angiographic results compared with DEB .


( Restenosis Intra-Stent of Drug-Eluting Stents : Drug-Eluting Balloon vs Everolimus-Eluting Stent -LSB- RIBS IV -RSB- ; NCT@ ) .


The aim of the present study was to evaluate whether the order of complementary feeding in relation to breast-feeding affects breast milk , semisolid , or total energy intake in infants .


The present study was designed as a randomized crossover trial .


The study was conducted in a tertiary care hospital .


The study participants were @ healthy infants between the ages of @ and @ months who were exclusively breast-fed for at least @ months and were now receiving complementary foods for at least @ month in addition to breast-feeding .


Infants were randomized to follow a sequence of either complementary feeding before breast-feeding ( sequence A ) or complementary feeding after breast-feeding ( sequence B ) for the first day ( @ hours ) of the study period using simple randomization .


For the next day , the sequence was reversed for each child .


All babies received @ actively fed complementary food meals per day ( morning , afternoon , and evening ) .


A semisolid study diet was prepared in the hospital by cooking rice and pulse with oil using a standard method , ensuring the energy density of at least @ kcal/g .


The infants were allowed ad libitum breast-feeding during the observation period .


Semisolid intake was directly measured and breast milk intake was quantified by test weighing method .


Energy intake from complementary foods was calculated from the product of energy density of the diet served on that day and the total amount consumed .


The total energy intake and energy intake from breast milk and complementary foods between the @ sequences were compared .


The mean ( standard deviation ) energy intake from breast milk during @ hours of daytime by following sequence A ( complementary feeding before breast-feeding ) was @ ( @ ) kcal in comparison with @ ( @ ) kcal in sequence B , which was not statistically different ( P = @ ) .


The mean ( standard deviation ) energy consumed from semisolids in sequences A and B was also comparable ( @ -LSB- @ -RSB- kcal vs. @ -LSB- @ -RSB- kcal ; P = @ ) .


The total energy intake during daytime in sequence A was @ ( @ ) kcal in comparison with @ ( @ ) kcal in sequence B , which was also comparable ( P = @ ) .


The results related to energy intake through breast milk and total energy intake were not different when insensible losses during feeding were adjusted in both groups .


Altering the sequence of complementary feeding in relation to breast-feeding does not affect total energy intake .


Our objective was to determine the interrelationships of interleukin ( IL ) -@ receptor inhibition with haemoglobin , acute-phase reactants and iron metabolism markers ( including hepcidin ) in patients with rheumatoid arthritis ( RA ) .


Data of patients receiving tocilizumab or placebo in the MEASURE study were analysed .


We investigated associations at baseline and during tocilizumab treatment among haemoglobin , parameters of haemoglobin and iron homeostasis -LSB- ferritin , total iron-binding capacity ( TIBC ) , hepcidin , haptoglobin -RSB- , IL-@ and acute-phase reactants -LSB- C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) -RSB- to identify statistical correlates of rise in haemoglobin level .


At baseline , CRP and haptoglobin were inversely correlated ( modestly ) with haemoglobin levels .


After treatment with tocilizumab , CRP , hepcidin , ferritin and haptoglobin levels fell alongside increases in TIBC and haemoglobin .


The falls in CRP , hepcidin and haptoglobin levels in the first @ weeks correlated with a week @ rise in TIBC and haemoglobin .


Inflammatory anaemia improves in patients with RA treated with tocilizumab .


This improvement correlates with the degree of suppression of systemic inflammation , reduction in hepcidin and haptoglobin and increase in iron-binding capacity .


These clinical data provide evidence of a role for IL-@ signalling in the inflammatory anaemia of RA .


In randomized clinical studies , over @,@ children , @ months to @ years of age , were administered ProQuad ( ) , a combination measles , mumps , rubella , and varicella vaccine ( MMRV ) .


This paper describes the safety following a @-dose regimen of MMRV administered to children in the second year of life .


Safety data from five clinical studies were combined for all children who were scheduled to receive two doses of MMRV @-@ months apart .


All vaccinated children were followed for safety following each dose of MMRV .


Of @ children who received a first dose of MMRV , @ ( @ % ) received a second dose of MMRV .


Overall , @ % and @ % of children reported @ adverse experiences following first and second doses of MMRV , respectively .


Injection-site redness was statistically significantly higher postdose @ than postdose @ , while injection-site pain/tenderness was statistically significantly higher postdose @ compared to postdose @ .


Rashes were statistically significantly lower postdose @ compared to postdose @ .


Ten febrile seizures ( @ postdose @ , @ postdose @ ) were reported following MMRV vaccination .


The incidence of febrile seizures postdose @ of MMRV was @ % ( @/@ ) compared to @ % ( @/@ ) postdose @ of MMRV .


Administration of two doses of MMRV has an acceptable safety profile in children @ to @ months of age .


There is a small increase in the risk of febrile seizures following the first dose of MMRV as compared to the component vaccines , but the risk for any individual child is relatively low .


To evaluate the cost-effectiveness of treating patients with acute coronary syndromes ( ACS ) for @ months with ticagrelor compared with generic clopidogrel in Sweden and Denmark .


Decision-analytic model to estimate lifetime costs , life-expectancy , and quality-adjusted life years ( QALYs ) with ticagrelor and clopidogrel .


Event rates , healthcare resource use , and health-related quality of life during @ months of therapy were estimated from the PLATelet inhibition and patient Outcomes ( PLATO ) trial .


Beyond @ months , quality-adjusted survival and costs were estimated conditional on events occurring during the @ months of therapy .


When available , country-specific data were employed in the analysis .


Incremental cost-effectiveness ratios are presented from a healthcare perspective and a broader societal perspective including costs falling outside the healthcare sector in @ local currency .


The cost per QALY with ticagrelor compared with generic clopidogrel was SEK @ @ and DKK @ @ for Sweden and Denmark , respectively , from a healthcare perspective .


The cost per QALY from a broader societal perspective was SEK @ @ and DKK @ @ for Sweden and Denmark , respectively .


The cost per QALY of treating ACS-patients with ticagrelor compared with generic clopidogrel is below the conventional thresholds of cost-effectiveness in Sweden and Denmark .


To evaluate the effectiveness of a food safety map as an educational method with English language learners .


English language learner community members ( n = @ ) were assigned randomly to participate in @ of @ experimental conditions : food safety map , cooking class , and control .


Participants in the food safety map and cooking class conditions completed a pre-education demographic and cooking history questionnaire , a post-education knowledge and intention questionnaire , and a @-week post-cooking and food safety habits assessment .


Participants in the control group received no educational training but completed the pre - and @-week post-education assessments .


The cooking class and the map class were both effective in increasing food safety knowledge .


Specifically , by comparing with the control group , they significantly increased participants ' knowledge of safely cooking large meat ( -LSB- df = @ , n = @ -RSB- = @ ; P < @ ; V * = @ ) and correctly refrigerating cooked food ( -LSB- df = @ , n = @ -RSB- = @ , P < @ ; V * = @ ) .


The two class types generated similar positive educational effects on boosting food safety behavioral intention ( measured right after the class ) .


The data collected @ weeks after the classes suggested that individuals who took the classes followed the suggested food behaviors more closely than those in the control group ( P < @ ) .


The food safety map is simple to use and prepare , beneficial for oral and visual learners , and inexpensive .


Compared with a food safety cooking class , the map produces similar learning and behavioral outcomes .


Despite a general lack of understanding of the underlying mechanisms , cold water immersion ( CWI ) is widely used by athletes for recovery .


This study examined the physiological merit of CWI for recovery from high-intensity exercise by investigating if the placebo effect is responsible for any acute performance or psychological benefits .


Thirty males ( mean SD : age , @ @ yr ; VO@ peak , @ @ mL kg ( -@ ) min ( -@ ) ) performed an acute high-intensity interval training session , comprised of @ @-s sprints , immediately followed by one of the following three @-min recovery conditions : CWI ( @ C @ C ) , thermoneutral water immersion placebo ( TWP ) ( @ C @ C ) , or thermoneutral water immersion control ( TWI ) ( @ C @ C ) .


An intramuscular thermistor was inserted during exercise and recovery to record muscle temperature .


Swelling ( thigh girth ) , pain threshold/tolerance , interleukin @ concentration , and total leukocyte , neutrophil , and lymphocyte counts were recorded at baseline , postexercise , postrecovery , and @ , @ , and @ h postexercise .


A maximal voluntary isometric contraction ( MVC ) of the quadriceps was performed at the same time points , with the exception of postexercise .


Self-assessments of readiness for exercise , fatigue , vigor , sleepiness , pain , and belief of recovery effectiveness were also completed .


Leg strength after the MVC and ratings of readiness for exercise , pain , and vigor were significantly impaired in TWI compared with those in CWI and TWP which were similar to each other .


A recovery placebo administered after an acute high-intensity interval training session is superior in the recovery of muscle strength over @ h as compared with TWI and is as effective as CWI .


This can be attributed to improved ratings of readiness for exercise , pain , and vigor , suggesting that the commonly hypothesized physiological benefits surrounding CWI are at least partly placebo related .


To compare the clinical effectiveness of two implant systems : Way Milano and Kentron ( Geass , Pozzuolo del Friuli , UD , Italy ) .


A total of @ patients requiring at least two single crowns or partial fixed dental prostheses supported by a maximum of three implants had their sites randomised according to a split-mouth design to receive both implant systems at six centres .


Patients were followed up for @ year after initial loading .


Outcome measures were : prosthesis/implant failures ; any complication ; peri-implant marginal bone level changes ; and clinician preference .


In total @ Way Milano and @ Kentron implants were placed .


Six patients dropped-out before the @-year follow-up , but all remaining patients were followed up to @ year post-loading .


No Way Milano implant failed , whereas three Kentron implants failed before loading .


Two complications were reported , one for each implant type .


There were no statistically significant differences for prosthesis/implant failures ( difference in proportions = @ , P = @ ; @ % CI -@ to @ ) and complications ( difference in proportions = @ , P = @ , @ % CI -@ to @ ) between the implant systems .


Three operators preferred Way Milano implants whereas the other three had no preference .


At implant placement ( baseline ) bone levels were higher for Way Milano implants ( @ mm ) than for Kentron implants ( @ mm ) .


Both groups gradually lost statistically significant amounts of periimplant marginal bone at @ months after loading and at @ year after loading .


One year after loading , Way Milano implants lost an average of @ mm peri-implant bone compared with @ mm of Kentron implants .


Marginal bone level changes were not statistically significant different for Way Milano compared to Kentron implants at @ months ( -@ mm , @ % CI -@ , @ ; P = @ ) and @ year ( -@ mm , @ % CI -@ , @ ; P = @ ) after loading .


No statistically significant differences were observed between the two implant types , although three Kentron implants failed versus none of the Way Milano type .


Longer follow-up of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs .


The risks and benefits of initiating antiretroviral treatment ( ART ) at high CD@ cell counts have not been reliably quantified .


The Strategic Timing of AntiRetroviral Treatment ( START ) study is a randomized international clinical trial that compares immediate with deferred initiation of ART for HIV-positive individuals with CD@ cell counts above @cells/L .


We describe the demographics , HIV-specific characteristics and medical history of this cohort .


Data collected at baseline include demographics , HIV-specific laboratory values , prior medical diagnoses and concomitant medications .


Baseline characteristics were compared by geographical region , gender and age .


START enrolled @ HIV-positive participants from @ sites in @ countries .


The median age is @ years -LSB- interquartile range ( IQR ) @-@ years -RSB- , @ % are female , and @ % self-identify as white , @ % as black , @ % as Latino/Hispanic , @ % as Asian and @ % as other .


The route of HIV acquisition is reported as men who have sex with men in @ % of participants , heterosexual sex in @ % , injecting drug use in @ % and other/unknown in @ % .


Median time since HIV diagnosis is @ year ( IQR @-@ @ years ) and the median CD@ cell count and HIV RNA values at study entry are @cells/L ( IQR @-@cells / L ) and @,@ HIV RNA copies/mL ( IQR @-@ ,@ copies/mL ) , respectively .


START has enrolled a diverse group of ART-nave individuals with high CD@ cell counts who are comparable to the HIV-positive population from the regions in which they were enrolled .


The information collected with this robust study design will provide a database with which to evaluate the risks and benefits of early ART use for many important outcomes .


Umbilical cord blood ( UCB ) is an important source of hematopoietic stem cells ( HSCs ) .


However , the concentration of cells in cord blood units is limited and this may represent the main restriction to their therapeutic clinical use .


The percentage of metabolically active stem cells provides a measure of the viability of cells in an UCB sample .


It follows that an active cellular metabolism causes a proliferation in stem cells , offering an opportunity to increase the cellular concentration .


A high cell dose is essential when transplanting cord stem cells , guaranteeing , in the receiving patient , a successful outcome.This study is designed to evaluate the impact of docosahexaenoic acid ( DHA ) supplementation in pregnant women , in order to increase the quantity and viability of the cells in UCB samples .


The metabolic demand of DHA increases in the course of pregnancy and reaches maximum absorption during the third trimester of pregnancy .


According to these observations , this trial will be divided into two different experimental groups : in the first group , participants will be enrolled from the @th week of estimated stage of gestation , before the maximum absorption of DHA ; while in the second group , enrolment will start from the @th week of estimated stage of gestation , when the DHA request is higher .


Participants in the trial will be divided and randomly assigned to the placebo group or to the experimental group .


Each participant will receive a complete set of capsules of either placebo ( @ mg of olive oil ) or DHA ( @ mg ) , to take one a day from the @th or from the @th week , up to the @th week of estimated gestational age .


Samples of venous blood will be taken from all participants before taking placebo or DHA , at the @th or at the @th week , and at the @th to @th week of pregnancy to monitor the level of DHA .


Cell number and cellular viability will be evaluated by flow cytometry within @ hours of the UCB sample collection .


Hotel-based sex workers in Bangladesh have high rates of sexually transmissible infections ( STIs ) , high client turnover and low condom use .


Two monthly clinic-based strategies were compared : periodic presumptive treatment ( PPT ) and enhanced syndromic management ( ESM ) - one round of presumptive treatment followed by treatment based on assessment and laboratory tests .


A randomised controlled trial compared PPT and ESM by prevalence and incidence , behaviour , retention , cost and STI incidence and prevalence .


Demographic , behavioural and clinical data were collected from women at two clinics in Dhaka .


All women received presumptive treatment and were randomised to receive PPT or ESM at nine monthly visits .


In total , @ women ( median age : < @ years ) were enrolled .


At baseline , the prevalence of chlamydia ( Chlamydia trachomatis ) and gonorrhoea ( Neisseria gonorrhoeae ) was @ % ( ESM : @ % ; PPT : @ % ) .


After @ months , chlamydia and gonorrhoea decreased to @ % overall , ( ESM : @ % ; PPT : @ % ) .


At each visit , @ % of women receiving ESM met the therapy criteria and were treated .


Retention was low ( @ % ) .


Total costs were @ % lower per visit for each woman for PPT ( ESM : $ @ v. PPT : $ @ ) .


The number of sex work sessions was reduced from @ to @ ( P < @ ) , but income did not change .


Coercion was reduced but condom use at last sex did not change significantly .


Monthly PPT and ESM were effective approaches for STI control .


PPT offered a feasible , low-cost alternative to ESM .


Educational aspects led to a reduction in coercion and fewer sessions .


Implementation studies are needed to improve condom use and retention .


Due to fragmented mental , somatic , and social healthcare services , it can be hard to engage into care older patients with severe mental illness ( SMI ) .


In adult mental health care , assertive community treatment ( ACT ) is an organizational model of care for treating patients with SMI who are difficult to engage .


So far all outcome studies of assertive community treatment have been conducted in adults .


In a randomized controlled trial design we compared the effectiveness of ACT for elderly patients with that of treatment as usual ( TAU ) .


Sixty-two outpatients ( @ years and older ) with SMI who were difficult to engage in psychiatric treatment were randomly assigned to the intervention or control group ( @ to ACT for elderly patients and @ to TAU ) .


Primary outcomes included number of patients who had a first treatment contact within @ months , the number of dropouts ( i.e. those discharged from care due to refusing care or those who unintentionally lost contact with the service over a period of at least @ months ) ; and patients ' psychosocial functioning ( HoNOS@ + scores ) during @ months follow-up .


Secondary outcomes included the number of unmet needs and mental health care use .


Analyses were based on intention-to-treat .


Of the @ patients who were randomized , @ were lost to follow-up ( @ patients in ACT for elderly patients and @ in TAU ) .


Relative to patients with TAU , more patients allocated to ACT had a first contact within three months ( @ versus @ % ; X@ ( df = @ ) = @ , p = @ ) .


ACT for elderly patients also had fewer dropouts from treatment ( @ % of assertive community treatment for elderly patients versus @ % of TAU patients ; X@ ( df = @ ) = @ , p = @ ) .


There were no differences in the other primary and secondary outcome variables .


These findings suggest that ACT for elderly patients with SMI engaged patients in treatment more successfully .


The aim of this study was to analyse effects of a comprehensive continuum of care ( intervention group ) on frail older persons ' life satisfaction , as compared to those receiving usual care ( control group ) .


The intervention included geriatric assessment , case management , interprofessional collaboration , support for relatives and organising of care-planning meetings in older persons ' own homes .


Improvements in older persons ' subjective well-being have been shown in studies including care planning and coordination by a case manager .


However , effects of more complex continuum of care interventions on frail older persons ' life satisfaction are not well explored .


Randomised controlled study .


The validated LiSat-@ scale was used in face-to-face interviews to assess older persons ' life satisfaction at baseline and at three , six and @ months after the baseline .


The odds ratio for improving or maintaining satisfaction was compared for intervention and control groups from baseline to three-month , three - to six-month as well as six - to @-month follow-ups .


Older persons who received the intervention were more likely to improve or maintain satisfaction than those who received usual care , between @ and @ month follow-ups , for satisfaction regarding functional capacity , psychological health and financial situation .


A comprehensive continuum of care intervention comprising several components had a positive effect on frail older persons ' satisfaction with functional capacity , psychological health and financial situation .


Frail older persons represent a great proportion of the persons in need of support from the health care system .


Health care professionals need to consider continuum of care interventions ' impact on life satisfaction .


As life satisfaction is an essential part of older persons ' well-being , we propose that policy makers and managers promote comprehensive continuum of care solutions .


To evaluate the changes of vascular endothelial growth factor ( VEGF ) plasma levels after intravitreal injections of aflibercept or ranibizumab in patients with exudative age-related macular degeneration ( AMD ) .


Thirty-eight patients with exudative AMD were included in this randomised , prospective study .


Nineteen patients were randomised to treatment with intravitreal aflibercept ( @ mg ) and @ to intravitreal ranibizumab ( @ mg ) .


The concentration of VEGF was measured by ELISA just before the injection , after @ days and @ month .


Twenty-two age - and sex-matched healthy patients without chorioretinal diseases served as control .


The median baseline plasma VEGF concentration was @ pg/ml in the control group , @ pg/ml in the aflibercept group and @ pg/ml in the ranibizumab group ( p = @ ) .


Seven days after intravitreal injection of aflibercept plasma levels were significantly reduced to values below the minimum detectable dose ( MDD ) in @ of @ patients ( @ % ) resulting in a median VEGF concentration of < @ pg/ml ( p < @ ) .


The reduction persisted throughout @ month with values below the MDD in @ of @ patients ( @ % ) and a median measurement of @ pg/ml ( p < @ ) .


In patients treated with ranibizumab no significant effects could be observed with a baseline VEGF of @ pg/ml , @ pg/ml at @ days ( p = @ ) and @ pg/ml at @ weeks of follow-up ( p = @ ) .


After intravitreal aflibercept injection , the systemic VEGF levels were significantly reduced throughout the observational period of @ weeks .


No significant systemic effects of intravitreal ranibizumab on plasma VEGF were observed .


A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide , social and educational impairment , and mental health problems in adulthood .


A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT programme in school classrooms .


The cost-effectiveness of the programme for preventing low mood and depression for all participants from a health and social care sector perspective needs to be determined .


A trial-based cost-effectiveness analysis based on a cluster-randomized controlled trial ( trial registration -- ISRCTN @ ) comparing classroom-based CBT with usual school provision of Personal Social and Health Education .


Per-student cost of intervention was estimated from programme records .


The study was undertaken in eight mixed-sex U.K. secondary schools , and included @,@ school children aged @ to @ years ( in the two trial arms evaluated in the cost-effectiveness analysis ) .


The main outcome measures were individual self-reported data on care costs , Quality-Adjusted Life-Years ( QALYs , based on the EQ-@D health-related quality-of-life instrument ) and symptoms of depression ( Short Mood and Feelings Questionnaire ) at baseline , @ and @ months .


Although there was lower quality-adjusted life-years over @ months ( -@ QALYs per person , @ % confidence interval -@ to -@ , p = @ ) with CBT , this is a ` clinically ' negligible difference , which was not found in the complete case analyses .


There was little evidence of any between-arm differences in SMFQ scores ( @ , @ % CI -@ to @ , p = @ ) , or costs ( @ , @ % CI -@ to @ , p = @ ) per person for CBT versus usual school provision .


Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision .


We investigated atorvastatin reloading effects on endothelial progenitor cell ( EPC ) count and inflammatory cytokine expression after percutaneous coronary intervention ( PCI ) in patients with stable angina pectoris who had previously received long-term statin treatments .


Patients with stable angina pectoris were treated with @ mg atorvastatin @ hours and @ mg atorvastatin @ hours before coronary angioplasty ( n = @ ) or preoperatively with @ mg/d atorvastatin for @ days ( n = @ ) or did not receive atorvastatin ( n = @ ) .


CD@ - / @ + / @ + , CD@ - / CD@ + / kinase insert domain receptor ( KDR ) + , and CD@ - / CD@ + / KDR + EPCs in the peripheral blood were determined by flow cytometry @ hour before as well as @ hour , @ hours , and @ hours after PCI .


Soluble intercellular adhesion molecule @ ( sICAM-@ ) , hypersensitive C-reactive protein ( hCRP ) , and troponin-I ( TnI ) serum concentrations were analyzed immediately prior to and @ hours after PCI .


In the @mg Atorvastatin and control groups , none of the analyzed EPC blood concentrations changed significantly from @h before operation to @h and @ h postoperative values .


In contrast , the number of circulating early differentiation stage EPCs CD@ - / @ + / @ + and CD@ - / CD@ + / KDR + raised significantly from @ h preoperative values ( @ ; @ @ ) to @ h postoperative ( ( @ @ ; @ @ ) , ( p < @ ) ) and @ h postoperative ( ( @ @ ; @ @ ) , ( p < @ ) ) concentrations after coronary angioplasty in the @mg Atorvastatin medication patients .


In the control group , the sICAM-@ ( @ @ vs @ @ ) and hCRP ( @ @ vs @ @ ) serum concentrations at @ hours after PCI were significantly elevated ( P < @ ) compared to preoperative values , whereas the increases in the @ groups treated with atorvastatin were not significant .


In addition , the rise in serum TnI concentration level from pre - to postoperative in the @-mg ( @ @ vs @ @ ) and the @-mg ( @ @ vs @ @ ) reloading groups was less than that of the controls ( @ @ vs @ @ ) ( p < @ ) .


Our results suggested that high-dose atorvastatin application before PCI triggered early EPC circulation .


Furthermore , postoperative inflammatory cytokine sICAM-@ as well as hCRP serum levels were reduced , while postinterventional myocardial injury marker TnI elevations were inversely correlated with statin reloadings .


Airway inflammation , mediated in part by LTB@ , contributes to lung destruction in patients with cystic fibrosis ( CF ) .


LTB ( @ ) - receptor inhibition may reduce airway inflammation .


We report the results of a randomized , double-blind , placebo-controlled study of the efficacy and safety of the leukotriene B ( @ ) ( LTB ( @ ) ) - receptor antagonist BIIL @ BS in CF patients .


CF patients aged @ years with mild to moderate lung disease were randomized to oral BIIL @ BS or placebo once daily for @ weeks .


Co-primary endpoints were change in FEV ( @ ) and incidence of pulmonary exacerbation .


After @ ( @ children , @ adults ) of the planned @ patients were randomized , the trial was terminated after a planned interim analysis revealed a significant increase in pulmonary related serious adverse events ( SAEs ) in adults receiving BIIL @ BS .


Final analysis revealed SAEs in @ % of adults receiving BIIL @ BS vs. @ % receiving placebo ( p = @ ) , and in @ % of children receiving BIIL @ BS vs. @ % receiving placebo ( p = @ ) .


In adults , the incidence of protocol-defined pulmonary exacerbation was greater in those receiving BIIL @ BS than in those receiving placebo ( @ % vs. @ % respectively ; p = @ ) .


In children , the incidence of protocol-defined pulmonary exacerbation was @ % in the BIIL @ BS arm , and @ % in the placebo arm ( p = @ ) .


While the cause of increased SAEs and exacerbations due to BIIL @ BS is unknown , the outcome of this trial provides a cautionary tale for the administration of potent anti-inflammatory compounds to individuals with chronic infections , as the potential to significantly suppress the inflammatory response may increase the risk of infection-related adverse events .


Alopecia areata is an idiopathic cause of hair loss with limited therapeutic repertoire .


To compare the efficacy and safety of a high - vs low-potency topical corticosteroid in pediatric patients .


This single-center , randomized , blind , @-arm , parallel-group , superiority trial was carried out over a @-week period at a tertiary referral academic dermatology clinic at The Hospital for Sick Children in Toronto , Ontario , Canada .


Forty-two children attending the outpatients clinic , @ to @ years of age with alopecia areata affecting at least @ % of scalp surface area , were eligible ; @ declined to participate .


There were no withdrawals from the study .


INTERVENTIONS FOR CLINICAL TRIALS : Patients were randomly assigned to receive clobetasol propionate , @ % cream , or hydrocortisone , @ % , cream .


Patients applied a thin layer of the assigned cream twice daily to the areas of hair loss for @ cycles of @ weeks on , @ weeks off , for a total of @ weeks .


The primary outcome was the change in scalp surface area with hair loss over @ weeks following enrollment .


RESULTS All participants were assessed at @ , @ , @ , and @ weeks ( except @ participant who missed the @-week visit ) .


After adjusting for baseline hair loss , the clobetasol group had a statistically significant ( P < @ ) greater decrease in the surface area with hair loss , compared with the hydrocortisone group at all time points except at @ weeks .


One patient with extensive alopecia areata experienced skin atrophy that resolved spontaneously in @ weeks .


There was no difference observed in the number of patients with abnormal urinary cortisol at the beginning and the end of the study .


Topical clobetasol propionate , @ % , cream is efficacious and safe as a first-line agent for limited patchy childhood alopecia areata .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


Given the limited sensitivity and specificity of prostate-specific antigen ( PSA ) , its widespread use as a screening tool has raised concerns for the overdiagnosis of low-risk and the underdiagnosis of high-grade prostate cancer .


To improve early-detection biopsy decisions , the National Cancer Institute conducted a prospective validation trial to assess the diagnostic performance of the prostate cancer antigen @ ( PCA@ ) urinary assay for the detection of prostate cancer among men screened with PSA .


In all , @ men ( mean age , @ years ) from @ centers scheduled for a diagnostic prostate biopsy between December @ and June @ were enrolled .


The primary outcomes were to assess whether PCA@ could improve the positive predictive value ( PPV ) for an initial biopsy ( at a score > @ ) and the negative predictive value ( NPV ) for a repeat biopsy ( at a score < @ ) .


For the detection of any cancer , PPV was @ % ( @ % CI , @ % to @ % ) in the initial biopsy group , and NPV was @ % ( @ % CI , @ % to @ % ) in the repeat biopsy group .


The addition of PCA@ to individual risk estimation models ( which included age , race/ethnicity , prior biopsy , PSA , and digital rectal examination ) improved the stratification of cancer and of high-grade cancer .


These data independently support the role of PCA@ in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy .


For biopsy-naive patients , a high PCA@ score ( > @ ) significantly increases the probability that an initial prostate biopsy will identify cancer .


Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy .


The quality of voice achieved with these treatments has not been compared in a randomized trial .


Male patients with carcinoma limited to @ mobile vocal cord ( T@aN@M@ ) were randomly assigned to receive either laser surgery ( n = @ ) or external beam radiation therapy ( n = @ ) .


Surgery consisted of tumor excision with a CO@ laser with the patient under general anaesthesia .


External beam radiation therapy to the larynx was delivered to a cumulative dose of @ Gy in @-Gy daily fractions over @ weeks .


Voice quality was assessed at baseline and @ and @ months after treatment .


The main outcome measures were expert-rated voice quality on a grade , roughness , breathiness , asthenia , and strain ( GRBAS ) scale , videolaryngostroboscopic findings , and the patients ' self-rated voice quality and its impact on activities of daily living .


Overall voice quality between the groups was rated similar , but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy .


Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living @ years after treatment .


Three patients in each group had local cancer recurrence within @ years from randomization .


Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding .


Overall voice quality was similar in both treatment groups , however , indicating a need for careful consideration of patient-related factors in the choice of a treatment option .


The current study was conducted to find out whether two oral preparations of @ mg gabapentin ( the test and reference capsules ) were bioequivalent .


This was a randomized , single-blind , crossover study under fasting condition , with a @-day washout period , which included @ healthy adult male and female subjects .


After an overnight fast , subjects were given , orally , one capsule of the test drug or of the reference drug .


Blood samples were drawn immediately before taking the drug , then at @ and @ minutes , and @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ hours after dosing , to evaluate pharmacokinetic parameters of the single dose administration , ie , the area under the plasma concentration-time curve ( AUC ) from time zero to @ hours ( AUCt ) , AUC from time zero to infinity ( AUC ( inf ) ) , the peak plasma concentration of the drug ( Cmax ) , time needed to achieve Cmax ( tmax ) , and the elimination half-life ( t@/@ ) .


The plasma concentrations of gabapentin were determined using validated high-performance liquid chromatography with ultraviolet detection .


The geometric mean ratios ( @ % confidence interval ) of the test drug/reference drug for gabapentin were @ % ( @ % -@ % ) for AUCt , @ % ( @ % -@ % ) for AUC ( inf ) , and @ % ( @ % -@ % ) for Cmax .


The differences in tmax and t@/@ values between the test and reference drug products for gabapentin were not statistically significant .


Light-headedness , nausea , and headache were encountered during the study , but they were all mild and well tolerated .


The @ % confidence intervals of the test/reference AUC ratio and Cmax ratio of gabapentin were within the acceptance range for bioequivalence .


The two preparations of gabapentin @ mg capsule were bioequivalent , thus both can be used interchangeably in the clinical setting .


We investigated the effects of @-year folic acid and vitamin B@ supplementation on cognitive performance in elderly people with elevated homocysteine ( Hcy ) levels .


This multicenter , double-blind , randomized , placebo-controlled trial included @,@ elderly participants ( @ years and older ) with Hcy levels between @ and @ mol/L .


Participants received daily either a tablet with @ g folic acid and @ g vitamin B@ ( B-vitamin group ) or a placebo tablet .


Both tablets contained @ g vitamin D@ .


Data were available for global cognitive functioning assessed by Mini-Mental State Examination ( n = @,@ ) , episodic memory ( n = @,@ ) , attention and working memory ( n = @ ) , information processing speed ( n = @ ) , and executive function ( n = @ ) .


Mean age was @ ( SD @ ) years .


Hcy concentrations decreased @ ( @ % confidence interval -@ to -@ ) mol/L in the B-vitamin group and @ ( -@ to -@ ) mol/L in the placebo group .


Cognitive domain scores did not differ over time between the @ groups , as determined by analysis of covariance .


Mini-Mental State Examination score decreased with @ ( -@ to @ ) in the B-vitamin group and @ ( -@ to -@ ) in the placebo group ( p = @ ) , as determined by an independent t test .


Two-year folic acid and vitamin B@ supplementation did not beneficially affect performance on @ cognitive domains in elderly people with elevated Hcy levels .


It may slightly slow the rate of decline of global cognition , but the reported small difference may be attributable to chance .


This study provides Class I evidence that @-year supplementation with folic acid and vitamin B@ in hyperhomocysteinemic elderly people does not affect cognitive performance .


Fluticasone furoate/vilanterol ( FF/VI ) is an inhaled corticosteroid/long-acting beta@-agonist ( ICS/LABA ) , recently approved as once-daily maintenance therapy for COPD .


We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol ( FP/SAL ) .


Three @ week studies comparing FF/VI and FP/SAL were conducted .


Patients aged @ years with moderate-to-very severe COPD were randomized to receive double-blind , double-dummy FF/VI @/@ mcg once-daily , or FP/SAL @/@ mcg twice-daily for @ weeks following a @ week placebo run-in period .


The primary endpoint of each study was change from baseline trough in @-@ h weighted mean FEV ( @ ) ( wmFEV ( @ ) ) on Day @ .


Safety was also assessed .


In Study @ ( HZC@ ) ( intent-to-treat n : FF/VI = @ ; FP/SAL = @ ) , the increase from baseline in @-@ h wmFEV ( @ ) was significantly greater with FF/VI than FP/SAL ( @ mL , P < @ ) .


In Study @ ( HZC@ ) ( intent-to-treat n : FF/VI = @ ; FP/SAL = @ ) and Study @ ( RLV@ ) ( intent-to-treat n : FF/VI = @ ; FP/SAL = @ ) , the increase from baseline in @-@ h wmFEV ( @ ) was not significantly greater with FF/VI than FP/SAL ( @ mL , P = @ ; @ mL , P = @ ) .


The treatment difference was statistically but not clinically significant in a pooled analysis ( @ mL , P < @ ) .


Pooled adverse events ( FF/VI @ % ; FP/SAL @ % ) and serious adverse events ( FF/VI @ % ; FP/SAL @ % ) were similar between treatments .


Our data suggest that once-daily FF/VI @/@ mcg provides FEV ( @ ) improvement in COPD that is at least comparable with that conferred by twice-daily FP/SAL @/@ mcg , although interpretation is limited by differences in individual study outcomes .


The safety profiles of FF/VI @/@ mcg and FP/SAL @/@ mcg are similar .


Atrial fibrillation ( AF ) is common in dialysis patients and is associated with increased morbidity and mortality .


The pathophysiology may be related to common risk factors for both AF and renal disease or to dialysis-specific factors .


The purpose of this study was to determine whether and how AF onset relates to the dialysis procedure itself .


All dialysis patients enrolled in the implantable cardioverter defibrillator-@ ( ICD-@ ) trial until January @ , who were implanted with an ICD , were included in this study .


Using the ICD remote monitoring function , the exact time of onset of all AF episodes was registered .


Subsequently , this was linked to the timing of dialysis procedures .


For the current study , a total of @ patients were included , follow-up was @ @ months , @ % male , @ @ years old .


A total of @ episodes of AF were monitored in @ patients .


AF onset was more frequent on the days of haemodialysis ( HD ) ( p < @ ) and specifically increased during the dialysis procedure itself ( p = @ ) .


Patients with AF had a larger left atrium ( p < @ ) and a higher systolic blood pressure before and after HD ( p < @ ) .


This study provides insight in the exact timing of AF onset in relation to the dialysis procedure itself .


In HD patients , AF occurred significantly more often on a dialysis day and especially during HD .


These findings might help to elucidate some aspects of the pathophysiology of AF in dialysis patients and could facilitate early detection of AF in these high-risk patients .


Low dose computerised tomography ( CT ) screening for lung cancer can reduce lung-cancer-specific mortality .


The objective of this study was to analyse healthcare costs and healthcare utilisation of participants in the Danish lung cancer CT-screening trial ( DLCST ) .


This registry study was nested in a randomised controlled trial ( DLCST ) .


@ participants , current or former heavy smokers , aged @-@ years were randomised to five annual low dose CT scans or usual care during @-@ .


Total healthcare costs and healthcare utilisation data for both the primary and the secondary healthcare sector were retrieved from public registries from randomisation - September @ and compared between ( @ ) the CT-screening group and the control group and , ( @ ) the control group and each of the true-positive , false-positive and true-negative groups .


The median annual costs per participant were significantly higher in the CT-screening group ( Euros -LSB- EUR -RSB- @ , interquartile range -LSB- IQR -RSB- @-@ ) compared with the control group ( EUR @ , IQR @-@ ) ( p < @ ) .


When the cost of the CT-screening programme was excluded , there was no longer a statistically significant difference between the CT-screening group ( EUR @ , IQR @-@ ) and the control group ( p = @ ) .


Analyses according to the diagnostic groups showed that annual costs were @ ( @ % CI @-@ @ ) times higher for the true-positive and @ ( @ % CI @-@ @ ) times higher for the false-positive group compared with the control group .


Low dose lung cancer CT screening increases healthcare costs compared with no screening ; this difference was attributable to the costs of the CT-screening programme .


Overall healthcare costs were higher for the true-positive and false-positive groups than for the control group , also when excluding the cost of the CT-screening programme .


This increase was outweighed by the larger true-negative group showing no significant differences in costs compared with the control group .


The purpose of this study was to investigate whether individualized deliberate practice on a virtual reality ( VR ) simulator results in improved technical performance in the operating room .


Training on VR simulators has been shown to improve technical performance in the operating room ( OR ) .


Currently described VR curricula consist of trainees practicing the same tasks until expert proficiency is reached .


It has yet to be investigated whether the individualized deliberate practice , where curricula tasks vary depending on prior levels of technical proficiency , would translate into the OR .


This single-blinded prospective trial randomized @ novice surgical residents to a deliberate practice ( DP ) group and a conventional residency training group .


Both groups performed a laparoscopic cholecystectomy in the OR that was video-recorded .


Technical performance of DP group residents in the OR was assessed using @ validated assessment tools .


A score of less than @ % on any component of the assessment tool resulted in the trainee practicing a specific task on the VR simulator .


The DP group practiced on the simulator as per their individualized schedule .


Both groups then performed another laparoscopic cholecystectomy .


A blinded expert assessed the OR recordings using a validated global rating scale .


Although both groups had similar technical abilities preintervention -LSB- DP : median score , @ ( @-@ @ ) ; control : median score , @ ( @-@ @ ) ; P = @ -RSB- , the DP residents had a superior technical performance postintervention -LSB- DP : median score , @ ( @-@ @ ) ; control : median score , @ ( @-@ @ ) ; P = @ -RSB- .


Of @ DP residents , @ practiced @ basic VR tasks ( median @ trial to pass ) , and @ of @ practiced @ advanced tasks ( median @ trials to pass ) .


A curriculum of deliberate individualized practice on a VR simulator improves technical performance in the OR .


This has implications to greatly improve the feasibility of implementing simulation-based curricula in residency training programs , rather then having them being limited to research protocols .


A @-week lunchtime walking intervention was designed to increase physical activity in physically inactive University employees .


The program was delivered and monitored twice over @ months to examine feasibility across different seasons .


Seventy-five participants ( n = @ females , n = @ males ; mean age = @ ) were randomly allocated into a Winter ( February start ) or Spring group ( May start ) .


Participants were asked to complete @ weekday lunchtime walks and @ weekend walks .


Weeks @ to @ were led by walk leaders ( group phase ) while the participants self-organized their walks during weeks @ to @ ( independent phase ) .


Yamax pedometers recorded daily step counts and walk group leaders recorded participant attendance in the group phase .


Acceptability was assessed via a satisfaction survey and @ focus groups with participants .


A participant pool representative by ethnicity , but not gender was recruited using a range of strategies .


The program demonstrated good retention across both groups ( @ % ) .


The intervention was acceptable to participants .


More steps were accumulated in the group-led versus the independent phase .


The intervention is feasible in this workplace setting across different seasonal periods .


In the future , researchers should examine if the findings can be replicated in a definitive trial and generalize to other workplace settings .


Ramosetron , a serotonin ( @-hydroxytryptamine ) -@ receptor antagonist with high selectivity , reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats .


However , there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome ( IBS-D ) .


We performed a randomized , double-blind , placebo-controlled trial to determine whether ramosetron reduces diarrhea in these patients .


Our study included @ male outpatients with IBS-D treated at @ centers in Japan .


Patients were given @ g oral ramosetron ( n = @ ) or placebo ( n = @ ) once daily for @ weeks after a @-week baseline period .


The primary end point was increased stool consistency in the first month .


Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life .


More patients given ramosetron ( @ , @ % ) than those given placebo ( @ , @ % ) reported improved stool consistency in the first month ( P < @ ) .


The relative risk and number needed to treat were @ ( @ % confidence interval , @-@ @ ) and @ ( @ % confidence interval , @-@ @ ) , respectively .


The ramosetron group had significantly higher monthly rates of relief of overall IBS symptoms and IBS-related quality of life than the placebo group .


Ramosetron ( @ g oral , once daily for @ weeks ) improved stool consistency in male patients with IBS-D , compared with placebo .


These study results , along with the pharmacologic profile of ramosetron , indicate that increased stool consistency is the best end point for studies of ramosetron in patients with IBS-D .


Clinicaltrials.gov No , NCT@ .


Formoterol fumarate ( FF ) is a well-established long-acting @-agonist .


This represents the first clinical study of FF in a metered-dose inhaler ( FF MDI ) based on proprietary lipid-based porous-particle engineering technology .


In this randomized , double-blind , @-period , crossover study ( NCT@ ) , subjects received @ , @ , and @ g of FF MDI , open-label Foradil ( ) Aerolizer ( ) ( FA ) @g , and placebo .


Spirometry was performed at baseline , @ and @min , and @ , @ , @ , @ , @ , @ , @ , and @h post-dose .


Thirty-four subjects were enrolled .


Improvement in forced expiratory volume in @s ( FEV@ ) was similar between FF MDI @ g and FA .


Change in FEV@ area under the curve for @-@h ( AUC@-@ ) for each FF MDI dose demonstrated superior efficacy versus placebo ( P < @ for all @ doses ) .


Over @h and at each time point , FF MDI @ g was non-inferior to FA for FEV@ AUC@-@ with the @ % CI 's supporting a maximum difference of approximately @mL .


Peak and trough FEV@ , forced vital capacity , peak expiratory flow rate , peak inspiratory capacity , and pharmacokinetics confirmed the primary endpoint , with dose ordering of the FF MDI @ , @ , and @ g , and comparability of FF MDI @ g to FA .


All @ doses of FF MDI were safe and well-tolerated , with a safety profile similar to that of placebo and FA .


The efficacy and pharmacokinetic profile of FF MDI @ g were comparable to FA @g and with similar safety to placebo and FA .


Fatigue is a common problem among multiple myeloma ( MM ) patients .


Armodafinil is a drug known to promote wakefulness , which is related to modafinil , a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents .


We investigated whether armodafinil could reduce cancer-related fatigue in MM patients .


This double-blind , placebo-controlled phase @ trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue .


Patients were randomized to one of two arms : treatment-only , with armodafinil given at @ mg/daily for @ days , or placebo-first , with placebo given on days @-@ , followed by armodafinil administered at @ mg daily on days @-@ .


Fatigue was measured on days @ ( pre-dose : baseline ) , @ , @ , @ , and @ using seven separate assessments , including four patient-reported outcomes of fatigue and related quality of life measures , as well as three objective measures of cognitive function .


Overall toxicities were similar between treatment groups .


No significant differences were observed between the placebo-first and the treatment-only arms after @ days .


Treatment with armodafinil for @ additional days did not produce responses .


Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day @ compared to baseline .


Placebo-first patients improved on eight additional measures ( one patient-reported measure , six subscales , and one objective task ) , suggesting a strong placebo effect in this patient population .


Evaluation and treatment of cancer-related fatigue continues to be challenging ; a clear definition of this symptom and better assessment tools are needed .


Opportunistic brief in-person emergency department ( ED ) interventions can be effective at reducing hazardous alcohol use in young adult drinkers , but require resources frequently unavailable .


Mobile telephone text messaging ( short message service -LSB- SMS -RSB- ) could sustainably deliver behavioral support to young adult patients , but efficacy remains unknown .


We report @-month outcome data of a randomized controlled trial testing a novel SMS-delivered intervention in hazardous-drinking young adults .


We randomized @ young adult ED patients who screened positive for past hazardous alcohol use to one of @ groups : SMS assessments + feedback ( SA+F ) intervention who were asked to respond to drinking-related queries and received real-time feedback through SMS each Thursday and Sunday for @ weeks ( n = @ ) , SMS assessments ( SA ) who were asked to respond to alcohol consumption queries each Sunday but did not receive any feedback ( N = @ ) , and a control group who did not participate in any SMS ( n = @ ) .


Primary outcomes were self-reported number of binge drinking days and number of drinks per drinking day in the past @ days , collected by Web-based timeline follow-back method and analyzed with regression models .


Secondary outcomes were the proportion of participants with weekend binge episodes and most drinks consumed per drinking occasion during @ weekends , collected by SMS .


With Web-based data , there were decreases in the number of self-reported binge drinking days from baseline to @ months in the SA+F group ( -@ -LSB- @ % confidence interval -LCB- CI -RCB- -@ to -@ -RSB- ) , whereas there were increases in the SA group ( @ -LSB- @ % CI @ to @ -RSB- ) and the control group ( @ -LSB- @ % CI -@ to @ -RSB- ) .


There were also decreases in the number of self-reported drinks per drinking day from baseline to @ months in the SA+F group ( -@ -LSB- @ % CI -@ to -@ -RSB- ) , whereas there were increases in the SA group ( @ -LSB- @ % CI -@ to @ -RSB- ) and the control group ( @ -LSB- @ % CI @ to @ -RSB- ) .


With SMS data , there was a lower mean proportion of SA+F participants reporting a weekend binge during @ weeks ( @ % -LSB- @ % CI @ % to @ % ) compared with the SA participants ( @ % -LSB- @ % CI @ % to @ % -RSB- ) .


There was also a lower mean drinks consumed per weekend during @ weeks in the SA+F group ( @ -LSB- @ % CI @ to @ -RSB- ) compared to the SA group ( @ -LSB- @ % CI @ to @ -RSB- ) .


A text message intervention can produce small reductions in self-reported binge drinking and the number of drinks consumed per drinking day in hazardous-drinking young adults after ED discharge .


To investigate the efficacy of a proactive feeding regimen ( PFR ) in reducing hospital length of stay in a population of moderately preterm small for gestational age ( SGA ) infants .


SGA infants ( z-score < -@ ) of gestational age ( GA ) @-@ weeks and birth weight ( BW ) > @ g were allocated at random to receive either a PFR , starting with @ mL/kg/day and gradually increasing to @ mL/kg/day by day @ , or a standard feeding regimen , starting with @ mL/kg/day and gradually increasing to @ mL/kg/day by day @ .


All infants received human milk .


A total of @ infants were randomized to the @ groups , @ to the PFR group ( mean GA , @ @ weeks ; mean BW , @ @ g ) and @ to the standard feeding regimen group ( mean GA , @ @ weeks ; mean BW , @ @ g ) .


Infants in the PFR group were discharged significantly earlier ( mean , @ @ days vs @ @ days ; P = @ ) .


The need for intravenous fluids ( @ % vs @ % ; P = @ ) and the incidence of hypoglycemia ( @ vs @ % ; P = @ ) were significantly lower in the PFR group .


Feeding intolerance and fecal calprotectin levels did not differ between the @ groups .


A PFR in moderately preterm SGA infants is well tolerated and significantly reduces both the length of stay and the risk of neonatal hypoglycemia .


The study aimed to confirm the efficacy , through non-inferiority , of patient-driven versus investigator-driven titration of biphasic insulin aspart @ ( BIAsp @ ) in terms of glycemic control assessed by HbA@c change .


SimpleMix was a @ week , open-label , randomized , two-armed , parallel-group , multicenter study in five countries ( Argentina , China , India , Poland , and the UK ) .


Patients with type @ diabetes were randomized into either patient-driven or investigator-driven BIAsp @ titration groups .


Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA@c from baseline to week @ could not be demonstrated .


Mean ( SE ) estimated change from baseline to week @ was -@ ( @ ) % in the patient-driven group and -@ ( @ ) % in the investigator-driven group ; estimated difference @ % ( @ % CI : @ ; @ ) .


Estimated mean change ( SE ) in fasting plasma glucose from baseline to week @ was similar between groups : -@ ( @ ) mmol/L for patient-driven and -@ ( @ ) mmol/L for investigator-driven ( difference non-significant ) .


Both treatment arms were well tolerated , and hypoglycemic episode rates were similar between groups , with a rate ratio of @ ( @ % CI : @ ; @ ; p = @ ) for all hypoglycemic episodes and @ ( @ % CI : @ ; @ ; p = @ ) for nocturnal hypoglycemic episodes .


Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA@c could not be confirmed .


It is possible that a clinic visit @ weeks after intensification of treatment with BIAsp @ in patients with type @ diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp @ .


A limitation of the study was the relatively small number of patients recruited in each country , which does not allow country-specific analyses to be performed .


Overall , treatment with BIAsp @ was well tolerated in both treatment groups .


Daylight-mediated photodynamic therapy ( DL-PDT ) using methyl-@-aminolaevulinate ( MAL ) is effective for thin , grade I , actinic keratoses ( AK ) .


There are no published studies of other photosensitizers used in DL-PDT .


To compare the efficacy and adverse effects of @-aminolaevulinic acid nanoemulsion ( BF-@ ALA ) with MAL in DL-PDT of grade I-III AKs .


In @ patients , @ AKs were randomized symmetrically for a split-face prospective observer-blinded study and received either BF-@ ALA or MAL DL-PDT .


Grade I AKs were treated once and grade II-III AKs twice with a @-mm layer of photosensitizer precursors .


Pain was assessed during and after the daylight exposure .


Efficacy at @months was assessed clinically and histologically .


BF-@ ALA cleared @/@ ( @ % ) and MAL @/@ ( @ % ) of the AKs ( P = @ ) , all grades responding equally , but with new AKs appearing during follow-up ( n = @ , BF-@ ALA ; n = @ , MAL ) .


In per patient half-face analysis BF-@ ALA showed significantly higher clearance rates for grade I AKs than did MAL ( P = @ ) , but for thicker grades , clearance was equal ( P = @ ) .


BF-@ ALA and MAL treatments resulted in @ % and @ % complete histological clearance ( P = @ ) , respectively .


p@ expression decreased by @ % and @ % , respectively ( P = @ ) .


Both treatments were nearly painless with similar adverse reactions and no difference in patient preference .


BF-@ ALA showed a trend towards improved efficacy results compared with MAL .


Thicker lesions in both groups responded when treated repeatedly .


Importantly , a thin @-mm layer of the photosensitizer precursors was sufficient , which may lead to lower expense .


DTaP@-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against @ diseases .


This multicenter , open-label , comparator-controlled , phase III study randomly assigned healthy infants @-to-@ as follows : group @ received DTaP@-IPV-Hib-HepB , PCV@ , and RV@ at @ , @ , and @ months of age followed by DTaP@ , Hib-OMP , and PCV@ at @ months of age ; group @ received DTaP@-IPV/Hib , PCV@ , and RV@ at @ , @ , and @ months of age , with HepB at @ and @ months of age , followed by DTaP@ , Hib-TT , and PCV@ at @ months of age .


Overall , @ participants were vaccinated in group @ and @ in group @ .


Immune responses in group @ to all antigens contained in DTaP@-IPV-Hib-HepB @ month after dose @ and for concomitant rotavirus vaccine were noninferior to those in group @ , with the exception of antipertussis filamentous hemagglutinin ( FHA ) geometric mean concentrations ( GMCs ) .


Vaccine response rates for FHA were noninferior to control .


After the toddler dose , group @ immune responses were noninferior to group @ for all pertussis antigens .


Solicited adverse event rates after any dose were similar in both groups , with the exceptions of increased injection-site erythema , increased fever , and decreased appetite in group @ .


Fever was not associated with hospitalization or seizures .


The safety and immunogenicity of DTaP@-IPV-Hib-HepB are comparable with the analogous licensed component vaccines .


Decreased FHA GMCs and increased injection-site reactions and fever are unlikely to be clinically significant .


DTaP@-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule .


In rural South Africa , only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ` prevention of mother-to-child transmission ' ( PMTCT ) services in @ .


Studies generally support male involvement to promote PMTCT , but the nature and impact of that involvement is unclear and untested .