Cardi@ yogurt did not reduce @-h , daytime or nighttime systolic or diastolic BPs compared with placebo ( P > @ ) .


Daytime and @-h heart rate ( HR ) were significantly reduced in the group treated by Cardi@ yogurt compared with the placebo group ( P < @ for both ) .


There were no differences in HbA@c , plasma lipids , C-reactive protein , plasminogen activator inhibitor-@ , tumour necrosis factor alpha , tissue-type plasminogen activator : Ag , and von Willebrand factor : Ag between the groups .


The change in fasting blood glucose concentration differed significantly between the two groups with a larger increase in the placebo group ( P < @ ) .


Ingestion of milk fermented with L. helveticus compared with placebo for @ weeks did not significantly reduce BP in patients with T@D .


Our finding of lower HRs and fasting plasma glucose levels in T@D patients during ingestion of fermented milk needs further validation .


Suboptimal virologic response to nucleos ( t ) ide analogs may represent a significant risk factor for resistance development in patients with chronic hepatitis B virus infection ; treatment options have not been well studied .


We evaluated long-term efficacy and safety of tenofovir alone and in combination with emtricitabine in a prospective , placebo-controlled trial in patients who remained viremic on adefovir therapy .


Hepatitis B e antigen-positive and - negative patients with hepatitis B virus DNA @ copies/ml despite up to @ weeks of adefovir were randomized to double-blind tenofovir or emtricitabine/tenofovir for @ weeks .


Patients with hepatitis B virus DNA @ copies/ml ( @IU/ml ) at or after week @ could switch to open-label emtricitabine/tenofovir .


Overall , @/@ ( @ % ) patients ( @/@ tenofovir and @/@ emtricitabine/tenofovir ) completed the @-week study period , including @/@ ( @ % ) patients ( @/@ tenofovir and @/@ emtricitabine/tenofovir ) who completed the study on their initial randomized treatment .


Long-term viral suppression ( hepatitis B virus DNA < @ copies/ml ) was maintained at week @ in @ % and @ % of patients receiving either emtricitabine/tenofovir combination or tenofovir monotherapy , respectively ( non-completer equal to failure analysis ) .


Baseline viral load as well as the presence of lamivudine and/or adefovir resistance-associated mutations at baseline had no impact on long-term treatment response .


No resistance to tenofovir was observed through @ weeks .


Both treatments had a favorable safety profile .


Tenofovir monotherapy is as effective as emtricitabine/tenofovir combination therapy in maintaining long-term viral suppression in patients with a suboptimal response to adefovir , and is well tolerated in this population .


To investigate the effectiveness of a school based intervention to increase physical activity , reduce sedentary behaviour , and increase fruit and vegetable consumption in children .


Cluster randomised controlled trial .


@ primary schools in the south west of England .


Primary school children who were in school year @ ( age @-@ years ) at recruitment and baseline assessment , in year @ during the intervention , and at the end of year @ ( age @-@ ) at follow-up assessment .


The Active for Life Year @ ( AFLY@ ) intervention consisted of teacher training , provision of lesson and child-parent interactive homework plans , all materials required for lessons and homework , and written materials for school newsletters and parents .


The intervention was delivered when children were in school year @ ( age @-@ years ) .


Schools allocated to control received standard teaching .


The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day , accelerometer assessed minutes of sedentary behaviour per day , and reported daily consumption of servings of fruit and vegetables .


@ schools with more than @ children were recruited ; valid data were available for fruit and vegetable consumption for @ children , for accelerometer assessed physical activity and sedentary behaviour for @ children , and for secondary outcomes for between @ and @ children for the main analyses .


None of the three primary outcomes differed between children in schools allocated to the AFLY@ intervention and those allocated to the control group .


The difference in means comparing the intervention group with the control group was -@ ( @ % confidence interval -@ to @ ) minutes per day for moderate to vigorous physical activity , -@ ( -@ to @ ) minutes per day for sedentary behaviour , and @ ( -@ to @ ) servings per day for fruit and vegetable consumption .


The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account : self reported time spent in screen viewing at the weekend ( -@ ( -@ to -@ ) minutes per day ) , self reported servings of snacks per day ( -@ ( -@ to -@ ) ) , and servings of high energy drinks per day ( -@ ( -@ to -@ ) ) were all reduced .


Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results .


The findings suggest that the AFLY@ school based intervention is not effective at increasing levels of physical activity , decreasing sedentary behaviour , and increasing fruit and vegetable consumption in primary school children .


Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level , as well as at the school environment level .


These findings have relevance for researchers , policy makers , public health practitioners , and doctors who are involved in health promotion , policy making , and commissioning services .


Trial registration Current Controlled Trials ISRCTN@ .


Central venous catheter ( CVC ) - related thrombosis and infections are frequently occurring complications in patients with hematological malignancies .


At present , heparin is most often used as a locking solution .


Trisodium citrate ( TSC ) had been shown to be a very effective antimicrobial catheter locking in hemodialysis patients .


We performed a prospective randomized phase III multicenter trial to determine the efficacy of TSC as a locking solution compared to heparin in preventing CVC-related thrombosis and infections in patients with hematological malignancies .


Thirty-four episodes of CVC-related bloodstream infections ( CVC-BSI ) occurred in the @ patients who were randomized to locking with heparin compared with @ episodes in the @ patients who were randomized to locking with TSC ( P = @ ) .


We did find seven times more CVC-BSI with gram-negative rods in CVCs locked with heparin ( P = @ ) .


The cumulative incidence of symptomatic thrombosis was @ % in the heparin group and @ % in the TSC group ( hazard ratio @ ; @ % confidence interval @-@ @ ) .


This study shows that locking with TSC in patients with hematological malignancies significantly reduced the incidence of CVC-BSI with gram-negative rods .


However , the incidence of CVC-BSI with coagulase-negative staphylococcus or CVC-related thrombosis was not reduced by TSC locking .


C-reactive protein ( CRP ) binds to damaged cells , activates the classical complement pathway , is elevated in multiple inflammatory conditions , and provides prognostic information on risk of future atherosclerotic events .


It is controversial , however , as to whether inhibiting CRP synthesis would have any direct anti-inflammatory effects in humans .


A placebo-controlled study was used to evaluate the effects of ISIS @ ( ISIS-CRPR x ) on the acute-phase response after endotoxin challenge in @ evaluable subjects .


Healthy adult males were randomly allocated to receive @ injections over a @-day period of placebo or active therapy with ISIS @ at @ - or @-mg doses .


Eligible subjects were subsequently challenged with a bolus of endotoxin ( @ ng/kg ) .


Inflammatory and hematological biomarkers were measured before and serially after the challenge .


ISIS-CRPR x was well tolerated with no serious adverse events .


Median CRP levels increased more than @-fold from baseline @ hours after endotoxin challenge in the placebo group .


In contrast , the median increase in CRP levels was attenuated by @ % ( @ mg ) and @ % ( @ mg ) in subjects pretreated with ISIS-CRPR x ( P < @ vs. placebo ) .


All other aspects of the acute inflammatory response were similar between treatment groups .


Pretreatment of subjects with ISIS-CRPR x selectively reduced the endotoxin-induced increase in CRP levels in a dose-dependent manner , without affecting other components of the acute-phase response .


These data demonstrate the specificity of antisense oligonucleotides and provide an investigative tool to further define the role of CRP in human pathological conditions .


We recently reported that epithelial-mesenchymal transition ( EMT ) is active in the airways in chronic obstructive pulmonary disease ( COPD ) , suggesting presence of an active profibrotic and promalignant stroma .


With no data available on potential treatment effects , we undertook a blinded analysis of inhaled corticosteroids ( ICS ) effects versus placebo on EMT markers in previously obtained endobronchial biopsies in COPD patients , as a `` proof of concept '' study .


Assessment of the effects of inhaled fluticasone propionate ( FP ; @ g twice daily for @ months ) versus placebo in @ COPD patients ( @ on fluticasone propionate and eleven on placebo ) .


The end points were epidermal growth factor receptor ( EGFR ; marker of epithelial activation ) and the biomarkers of EMT : reticular basement membrane ( Rbm ) fragmentation ( `` hallmark '' structural marker ) , matrix metalloproteinase-@ ( MMP-@ ) cell expression , and S@A@ expression in basal epithelial and Rbm cells ( mesenchymal transition markers ) .


Epithelial activation , `` clefts/fragmentation '' in the Rbm , and changes in the other biomarkers all regressed on ICS , at or close to conventional levels of statistical significance .


From these data , we have been able to nominate primary and secondary end points and develop power calculations that would be applicable to a definitive prospective study .


Although only a pilot `` proof of concept '' study , this trial provided strong suggestive support for an anti-EMT effect of ICS in COPD airways .


A larger and fully powered prospective study is now indicated as this issue is likely to be extremely important .


Such studies may clarify the links between ICS use and better clinical outcomes and protection against lung cancer in COPD .


The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback ( Bleeper Sv ; Vertec Scientific Ltd ; Berkshire , UK ) on patient dose and operator exposure during cardiac catheterization .


Between January @ and May @ , @ patients undergoing coronary angiography , percutaneous coronary intervention , or both were randomized to use ( n = @ ) or no use ( n = @ ) of the Bleeper Sv radiation monitor .


Operator radiation exposure was measured in both groups using a second , silent radiation exposure monitoring device .


Mean patient age was @ years , most patients ( @ % ) were men , and @ % had prior coronary artery bypass graft surgery .


Baseline clinical characteristics were similar in the @ study groups .


Radial access was used in @ % and chronic total occlusion percutaneous coronary intervention constituted @ % of the total procedures .


Median procedure time was @ ( @-@ ) minutes for diagnostic angiography , @ ( @-@ ) minutes for percutaneous coronary intervention , and @ ( @-@ ) minutes in the overall study population , with similar distribution between the study groups .


First ( @ -LSB- @-@ -RSB- versus @ -LSB- @-@ -RSB- Sv ; P < @ ) and second ( @ -LSB- @-@ -RSB- versus @ -LSB- @-@ -RSB- Sv ; P < @ ) operator radiation exposure was significantly lower in the Bleeper Sv group .


Use of the device did not result in a significant reduction in patient radiation dose .


The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups .


Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization .


Aerobic exercise training is a recognized approach for improving functional capacity in COPD .


People with greater disease severity often have difficulty achieving higher aerobic exercise training intensity .


The effects of resistance training prior to aerobic training were examined to determine if this sequential approach was associated with greater gains in functional status than aerobic training alone or concurrent aerobic and resistance training .


Patients were randomized to : @ ) sequential resistance then aerobic training ( RT-then-AT ) ( @ weeks resistance training followed by @ weeks aerobic exercise training ) , @ ) control group ( CE-then-AT + RT ) ( @ weeks of ` sham ' training followed by @ weeks concurrent aerobic and resistance training ) , @ ) control group ( CE-then-AT ) ( @ weeks ` sham ' training followed by @ weeks aerobic training ) .


Outcomes were assessed at study entry , after week @ , and after week @ : aerobic exercise performance ; muscle strength and endurance .


@ patients completed training : FEV@ % pred @ @ , VO ( @peak ) % predicted , @ @ , fat-free mass index @ @ .


RT-then-AT had greater acquisition of peripheral muscle endurance than CE-then-AT + RT and CE-then-AT , but improvements in aerobic exercise performance were similar .


Improvements in muscle strength were similar between RT-then-AT and CE-then-AT + RT. .


Sarcopenia was associated with poorer attendance , and lower aerobic and resistance training volumes .


Although the sequential approach to resistance and aerobic training yielded a greater increase in muscle endurance and higher resistance training volume compared to concurrent resistance and aerobic training , other training outcomes were similar between the two groups , thus the sequential approach is not clearly superior to the concurrent approach in severe COPD .


ClinicalTrials.gov Identifier : NCT@ .


The association between epicardial adipose tissue ( EAT ) volume and coronary artery disease ( CAD ) severity was evaluated , independent of traditional risk factors and coronary artery calcium ( CAC ) scores , in patients with diabetes type @ ( DM-@ ) using cardiac computed tomography angiography ( CTA ) .


A multivariate analysis was utilized to assess for an independent association after calculating EAT volume , CAD severity , and calcium scores in @ patients with DM-II from the CTRAD study .


We graded CAD severity as none ( normal coronaries ) , mild-moderate ( < @ % stenosis ) , and severe ( @ % or greater stenosis ) .


A total of @ ( @ % ) asymptomatic patients with diabetes did not have CAD ; @ % had mild/moderate CAD ; and @ % had severe CAD .


Mean EAT volume was highest in patients with severe CAD ( @ cm ( @ ) ) as compared to mild/moderate CAD ( @ cm ( @ ) ) , and no CAD ( @ cm ( @ ) ) ( p = @ ) .


After adjustment of clinical risk factors , notably , CAC score , multivariate regression analysis showed EAT volume was an independent predictor of CAD severity in this sample ( odds ratio @ , @ % confidence interval @-@ @ , p = @ ) .


Increasing EAT volume in asymptomatic patients with DM-II is associated with presence of severe CAD , independent of BMI and CAC , as well as traditional risk factors .


To evaluate the efficacy and safety of mite allergen specific immunotherapy ( SIT ) in treating children with allergic asthma .


A total of @ patients with mite allergy were recruited into the study .


They were randomly divided into two groups : SIT group ( n = @ ) and ST ( symptomatic therapy ) group ( n = @ ) .


They were investigated of SIT with standardized allergen vaccine or no SIT only symptomatic therapy respectively .


Therapeutic evaluation index includes : asthma symptoms score , drug score , skin prick test , pulmonary function , serum specificity IgE ( sIgE ) and the new sensitization was also assessed .


Local and systemic adverse reactions were used to evaluate the clinical safety .


Clinical symptom scores , drug scores , Lung function , and skin test result all improved significantly after the treatment with SIT compared to ST group ( P < @ ) .


SIT groups do not have new sensitization and no fatal systemic reactions occurred .


The standardized dust mite allergen specific immunotherapy is efficacious and safe to Children with allergic asthma .


SIT can reduce house dust mites skin sensitivity and prevent new allergen appeared .


No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of ( cost ) effectiveness .


To compare bed baths for effects on skin integrity and resistance against bathing and costs .


Cluster randomized trial .


Fifty six nursing home wards in the Netherlands .


Participants : Five hundred adult care-dependent residents and @ nurses from nursing home wards .


The experimental condition ` washing without water ' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers , saturated with a no-rinse , quickly vaporizing skin cleaning and caring lotion .


The control condition is a traditional bed bath using soap , water , washcloths and towels .


Both conditions were continued for @ weeks .


Outcome measures were prevalence of skin damage distinguished in two levels of severity : any skin abnormality/lesion and significant skin lesions .


Additional outcomes : resistance during bed baths , costs .


Any skin abnormalities/lesions over time decreased slightly in the experimental group , and increased slightly in the control group , resulting in @ % vs @ % of residents having any skin abnormalities/lesions after @ weeks , respectively ( p = @ ) .


There were no differences in significant skin lesions or resistance after @ weeks .


Mean costs for bed baths during @ weeks per resident were estimated at @ ( @ % CI @-@ @ ) in the experimental group and @ ( @ % CI : @-@ @ ) in the control group ( difference @ ( @ % CI : -@ -@ ) .


Washing without water mildly protects from skin abnormalities/lesions , costs for preparing and performing bed baths do not differ from costs for traditional bed bathing .


Thus , washing without water can be considered the more efficient alternative .


The aim of this study is to investigate the effectiveness of preemptive thoracic epidural analgesia ( TEA ) comparing conventional postoperative epidural analgesia on thoracotomy .


Forty-four patients were randomized in to two groups ( preemptive : Group P , control : Group C ) .


Epidural catheter was inserted in all patients preoperatively .


In Group P , epidural analgesic solution was administered as a bolus before the surgical incision and was continued until the end of the surgery .


Postoperative patient controlled epidural analgesia infusion pumps were prepared for all patients .


Respiratory rates ( RR ) were recorded .


Patient 's analgesia was evaluated with visual analog scale at rest ( VASr ) and coughing ( VASc ) .


Number of patient 's demands from the pump , pump 's delivery , and additional analgesic requirement were also recorded .


RR in Group C was higher than in Group P at postoperative @st and @nd hours .


Both VASr and VASc scores in Group P were lower than in Group C at postoperative @st , @nd , and @th hours .


Patient 's demand and pump 's delivery count for bolus dose in Group P were lower than in Group C in all measurement times .


Total analgesic requirements on postoperative @st and @th hours in Group P were lower than in Group C.


We consider that preemptive TEA may offer better analgesia after thoracotomy .


and purpose Participant recruitment is central to all clinical trials .


Any delay in recruitment affects the completion and ultimate success of the trial .


We report our experience with patient screening and randomization in CombiRx , which may inform the design of other trials .


CombiRx was a multicenter , phase III , double-blind , randomized clinical trial comparing the combined use of interferon beta-@a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis ( RRMS ) .


This trial was launched in January @ in @ centers in the United States and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke ( NINDS ) .


The goal was to recruit @ patients over @ years after a @-month start-up period .


Instead , the investigators required @ years to enroll @ patients .


During this trial , we assessed the effectiveness of various recruitment strategies , utility of rescreening prior screen failures , and potential factors and strategies used in study conduct , research , and infrastructure , all of which affected recruitment of participants and ultimately time to completion of CombiRx .


We particularly were interested in the variability in time to site initiation between academic centers and private practice sites .


Physicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx .


A flexible study design that allowed for rescreening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease .


Academic centers took longer to implement the trial than the private practice centers , but once sites were approved for enrollment , there was no important difference in the number of participants enrolled .


The CombiRx trial was conducted during a period when multiple new medications were being tested , thus affecting the pace of recruitment and limiting ability to generalize our experiences .


However , the lessons we learned about process are relevant .


Participants can be enrolled successfully in a clinical trial for RRMS , but factors affecting the time to achieve the requirements needed to start screening can be unpredictable and problematic .


Prospective planning by the sponsors and investigators , use of central institutional review boards ( IRBs ) , master trial agreements and secure remote desktop access to the trial database may expedite trial implementation and participant recruitment .


A good scientific research question with flexible study design and active involvement of the clinicians are important factors driving recruitment .


Clinical trials can be implemented successfully both in private practices and at academic centers , a consideration when selecting sites .


Primary health care in Tanzania is provided at two types of health units , the dispensary and the health centre .


Theoretically , primary health workers ( with knowledge of primary eye care -LSB- PEC -RSB- ) are ideally placed to identify people in need of eye care services .


In Tanzania , they are expected to be able to identify , treat , or correctly refer a number of eye conditions including cataract , trauma , presbyopia , and the ` red eye ' .


They are also expected to be able to measure visual acuity correctly and to educate the community about prevention .


The objective was to determine the effect of enhanced supervision of health workers on PEC knowledge and skills in Kilimanjaro Region , Tanzania .


This was a quasi-experimental , cluster randomized intervention study of an enhanced supervisory method compared to a routine supervisory method ; @ dispensaries were randomly allocated into the two groups .


Health workers based at government dispensaries in Mwanga District .


Participants were interviewed pre and post intervention and the information was recorded using a standardized pretested questionnaire .


Mean scores of knowledge in healthcare workers was higher in the intervention group ( score = @ , @ % improvement ) compared to the non-intervention group ( score = @ , @ % improvement ) .


The ability to describe and demonstrate vision testing was better ( score = @ ) in the enhanced supervision group compared to the routine supervision group ( score = @ , P = @ ) .


There was a high level of attrition ( @ % ) within one year from the time of baseline survey , especially amongst clinical officers ( @ % ) .


During the pilot study , enhanced supervision improved PEC knowledge and skills of health workers compared to health workers with routine supervision .


Training in PEC needs revision to become more practicum-based .


There is need to revise supervision guidelines ( to be skills-based ) and the supervision skills of district eye coordinators ( DECs ) need to be enhanced .


There is a huge need to improve governance ( accountability and rule of law ) of health staff .


To assess differences between manual wheelchairs and @ pushrim-activated power-assisted wheelchairs ( PAPAWs ) : Servomatic A and B and E-motion .


Repeated measures .


Rehabilitation hospital .


Volunteers with spinal cord injuries ( N = @ ) .


Ten subjects propelled the wheelchairs on a dynamometer , @ evaluated each wheelchair on indoor and outdoor courses , and @ evaluated their ability to transfer themselves and their wheelchairs into and out of their car .


Oxygen consumption per unit time ( Vo@ ) and heart rate were measured during propulsion on the dynamometer .


Wheelchair efficiency on the indoor and outdoor courses was evaluated on the basis of heart rate , completion time , handrim push frequency , and patient satisfaction .


On the dynamometer , decreases in Vo@ and heart rate were similar with the @ PAPAWs compared with manual wheelchairs .


On the outdoor course , heart rate was significantly decreased by PAPAWs compared with manual wheelchairs and patient satisfaction was better with Servomatic devices than with the E-motion device .


Indoors , the course completion time was longer with the E-motion wheelchair than with other wheelchairs in the overall population , and handrim push frequency was higher with the E-motion wheelchair than with other wheelchairs in the subgroup with T@ to L@ injuries .


Car transfer ability was lower with PAPAWs than with manual wheelchairs .


Differences exist across PAPAWs .


Compared with E-motion , the @ Servomatic PAPAWs were easier to use outdoors , and difficulty transferring into/out of the car was similarly increased with all @ PAPAWs .


Bipolar disorders ( BD ) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood .


The long latency in clinical diagnosis ( and subsequent adequate treatment ) adversely affects the course of disease , effectiveness of interventions and health-related quality of life , and increases the economic burden of BD .


Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD , many adolescents and young adults seek help , and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school , training , at work and in their social relationships .


We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy ( CBT ) in this subpopulation .


EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT , including stress management and problem solving strategies , with elements of mindfulness-based therapy ( MBT ) versus unstructured group meetings for @weeks each and follow-up until week @ .


Participants are recruited at seven university hospitals throughout Germany , which provide in - and outpatient care ( including early recognition centres ) for psychiatric patients .


Subjects at high risk must be @ to @years old and meet the combination of specified affective symptomatology , reduction of psychosocial functioning , and family history for ( schizo ) affective disorders .


Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at @weeks between groups .


Secondary endpoints include the above mentioned endpoints at @ , @ , @ and @weeks and the change within groups compared to baseline ; perception of , reaction to and coping with stress ; and conversion to full BD .


To our knowledge , this is the first study to evaluate early specific CBT in subjects at high risk for BD .


Structured diagnostic interviews are used to map the risk status and development of disease .


With our study , the level of evidence for the treatment of those young patients will be significantly raised .


A primary goal of acute ischemic stroke ( AIS ) management is to maximize perfusion in the affected region and surrounding ischemic penumbra .


However , interventions to maximize perfusion , such as flat head-of-bed ( HOB ) positioning , are currently prescribed empirically .


Bedside monitoring of cerebral blood flow ( CBF ) allows the effects of interventions such as flat HOB to be monitored and may ultimately be used to guide clinical management .


Cerebral perfusion was measured during HOB manipulations in @ patients with unilateral AIS affecting large cortical territories in the anterior circulation .


Simultaneous measurements of frontal CBF and arterial flow velocity were performed with diffuse correlation spectroscopy and transcranial Doppler ultrasound , respectively .


Results were analyzed in the context of available clinical data and a previous study .


Frontal CBF , averaged over the patient cohort , decreased by @ % ( P = @ ) and @ % ( P = @ ) in the ipsilesional and contralesional hemispheres , respectively , when HOB was changed from flat to @ .


Significant ( cohort-averaged ) changes in blood velocity were not observed .


Individually , varying responses to HOB manipulation were observed , including paradoxical increases in CBF with increasing HOB angle .


Clinical features , stroke volume , and distance to the optical probe could not explain this paradoxical response .


A lower HOB angle results in an increase in cortical CBF without a significant change in arterial flow velocity in AIS , but there is variability across patients in this response .


Bedside CBF monitoring with diffuse correlation spectroscopy provides a potential means to individualize interventions designed to optimize CBF in AIS .


Trastuzumab ( Herceptin ( ) ) is a humanized monoclonal antibody targeting the human epidermal growth factor receptor @ ( HER@ ) and is used in the treatment of HER@-overexpressing breast and gastric cancer .


FTMB is being developed as a biosimilar of trastuzumab .


In this combined dose-escalation and bioequivalence study of parallel design , the pharmacokinetic profile of FTMB was compared with Herceptin ( ) .


Healthy male volunteers received single doses of @ , @ , @ or @ mg/kg FTMB , or placebo , in consecutive dose-escalation cohorts to assess the safety profile .


Thereafter , the @ mg/kg cohort was expanded to establish bioequivalence between FTMB ( Test ) and Herceptin ( ) ( Reference ) based on an acceptance interval of @-@ @ % .


In total , @ subjects were enrolled in the study .


The mean area under the concentration-time curve from time zero to infinity ( AUC ) was @,@ gday/mL ( Test ) and @,@ gday/mL ( Reference ) .


The log-transformed geometric mean Test/Reference ( T/R ) ratio for AUC was @ % ( @ % confidence interval -LSB- CI -RSB- @-@ @ ) , demonstrating bioequivalence .


For the secondary endpoint , the maximum concentration observed ( Cmax ) , the geometric mean T/R ratio was @ % ( @ % CI @-@ @ ) .


Non-linear , target-mediated pharmacokinetics were also observed .


Adverse events other than the documented side effects of Herceptin ( ) ( fever , influenza-like illness , and fatigue ) did not occur .


No signs of cardiotoxicity were observed .


This bioequivalence study with a trastuzumab biosimilar in healthy male volunteers demonstrated bioequivalence of FTMB with Herceptin ( ) .


FTMB was well tolerated in doses up to @ mg/kg .


Non-linear target elimination was also observed in the pharmacokinetic profile of trastuzumab .


Nutritional insults and conditions during fetal life and infancy influence subsequent growth and body composition of children .


Effects of maternal food and micronutrient supplementation and exclusive breastfeeding counseling on growth of offspring aged @-@ months and their body composition at @ months of age were studied .


In the MINIMat trial ( ISRCTN@ ) in Matlab , Bangladesh , pregnant women were randomized to early ( around @ weeks ) or usual invitation ( around @ weeks ) to food supplementation and to one of the three daily micronutrient supplements : @-mg Fe and @-g folic acid ( Fe@F ) , @-mg Fe and @-g folic acid ( Fe@F ) , and multiple micronutrient supplements ( MMS ) .


The supplements were also randomized to exclusive breastfeeding ( EBF ) counseling or to usual health messages .


No differences in background characteristics were observed among the intervention groups .


There was also no differential effect of prenatal interventions on birthweight or birthlength .


Early food supplementation reduced the level of stunting from early infancy up to @ months of age among boys ( average difference - @ % units , @ % confidence interval -LSB- CI -RSB- @-@ @ , p = @ ) but not among girls ( average difference - @ % units , @ % CI -@ -@ , p = @ ) .


MMS resulted in more stunting compared to standard Fe@F ( average difference - @ % units , @ % CI @-@ @ , p = @ ) .


Breastfeeding counseling prolonged the duration of EBF ( difference - @ days , @ % CI @-@ @ , p < @ ) .


Neither pregnancy interventions nor breastfeeding counseling influenced the body composition of children at @ months of age .


Early food supplementation during pregnancy reduced the occurrence of stunting among boys aged @-@ months , while prenatal MMS increased the proportion of stunting .


Food and micronutrient supplementation or EBF intervention did not affect body composition of offspring at @ months of age .


The effects of prenatal interventions on postnatal growth suggest programming effects in early fetal life .


Limited evidence suggests that dietary interventions may offer a promising approach for migraine .


The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency .


Forty-two adult migraine sufferers were recruited from the general community in Washington , DC , and divided randomly into two groups .


This @-week crossover study included two treatments : dietary instruction and placebo supplement .


Each treatment period was @ weeks , with a @-week washout between .


During the diet period , a low-fat vegan diet was prescribed for @ weeks , after which an elimination diet was used .


Participants were assessed at the beginning , midpoint , and end of each period .


Significance was determined using student 's t-tests .


Worst headache pain in last @ weeks , as measured by visual analog scale , was initially @ / @ cm ( SD @ cm ) , and declined @ cm during the diet period and @ cm during the supplement period ( p = @ ) .


Average headache intensity ( @-@ scale ) was initially @ ( SD @ ) per week , and this declined by @ during the diet period and by @ during the supplement period ( p = @ ) .


Average headache frequency was initially @ ( SD @ ) per week , and this declined by @ during the diet period and by @ during the supplement period ( p = @ ) .


The Patient 's Global Impression of Change showed greater improvement in pain during the diet period ( p < @ ) .


These results suggest that a nutritional approach may be a useful part of migraine treatment , but that methodologic issues necessitate further research .


The purpose of this study was to determine if educating parents with visual aids after their child 's treatment under general anesthesia would improve attendance at follow-up appointments , oral health outcomes , and treatment satisfaction .


Fifty-four parent-child dyads were recruited and randomly assigned to two groups .


The control group received verbal education , and the intervention group received verbal and visual education .


Oral health was measured using the Gingival Index and the Simplified Oral Hygiene Index ( OHI-S ) before and after the treatment .


Parent surveys were administered before and after treatment .


MResults : Seventy-eight percent of the intervention group and @ percent of the control group returned for follow-up appointments ( P = @ ) .


The plaque index decreased ( P < @ ) ; the reported brushing frequency increased for all children from baseline to follow-up visit ( P = @ ) .


The satisfaction increased only for parents in the intervention group over time ( P = @ ) .


Using visual aids had a positive impact on patient attendance at follow-up and parents ' treatment satisfaction .


There was an improvement in oral hygiene , as measured by the OHI-S , and an increase in brushing frequency for all children , regardless of whether their parents were educated with or without a visual aid .


To evaluate the association between adolescent and young-adult hearing loss and nonverbal intelligence in rural Nepal .


Cross-sectional assessment of hearing loss among a population cohort of adolescents and young adults .


Sarlahi District , southern Nepal .


Seven hundred sixty-four individuals aged @ to @ years .


Evaluation of hearing loss , defined by World Health Organization criteria of pure-tone average greater than @ decibels ( @ , @ , @ , @ kHz ) , unilaterally and bilaterally .


Nonverbal intelligence , as measured by the Test of Nonverbal Intelligence , @rd Edition standardized score ( mean , @ ; standard deviation , @ ) .


Nonverbal intelligence scores differed between participants with normal hearing and those with bilateral ( p = @ ) but not unilateral ( p = @ ) hearing loss .


Demographic and socioeconomic factors including male sex ; higher caste ; literacy ; education level ; occupation reported as student ; and ownership of a bicycle , watch , and latrine were strongly associated with higher nonverbal intelligence scores ( all p < @ ) .


Subjects with bilateral hearing loss scored an average of @ points lower ( @ % confidence interval , -@ to -@ ; p = @ ) than subjects with normal hearing after controlling for socioeconomic factors .


There was no difference in nonverbal intelligence score based on unilateral hearing loss ( @ ; @ % confidence interval , -@ to @ ; p = @ ) .


Nonverbal intelligence is adversely affected by bilateral hearing loss even at mild hearing loss levels .


Socio economic well-being appears compromised in individuals with lower nonverbal intelligence test scores .


Cardiovascular complications are the leading cause of mortality and morbidity in Marfan syndrome ( MFS ) , a dominantly inherited disorder caused by mutations in the gene that encodes fibrillin-@ .


There are approximately @,@ patients in the UK with MFS .


Current treatment includes careful follow-up , beta blockers , and prophylactic surgical intervention ; however , there is no known treatment which effectively prevents the rate of aortic dilatation in MFS .


Preclinical , neonatal , and pediatric studies have indicated that angiotensin receptor blockers ( ARBs ) may reduce the rate of aortic dilatation .


This trial will investigate the effects of irbesartan on aortic dilatation in Marfan syndrome .


The Aortic Irbesartan Marfan Study ( AIMS ) is an investigator-led , prospective , randomized , placebo-controlled , double-blind , phase III , multicenter trial .


Currently , @ centers in the UK will recruit @ clinically confirmed MFS patients ( aged @ to @ years ) using the revised Ghent diagnostic criteria .


Patients will be randomized to irbesartan or placebo .


Aortic root dilatation will be measured by transthoracic echocardiography at baseline and annually thereafter .


The primary outcome is the absolute change in aortic root diameter per year measured by echocardiography .


The follow-up period will be a minimum of @ months with an expected mean follow-up period of @ months .


This is the first clinical trial to evaluate the ARB irbesartan versus placebo in reducing the rate of aortic root dilatation in MFS .


Not only will this provide useful information on the safety and efficacy of ARBs in MFS , it will also provide a rationale basis for potentially lifesaving therapy for MFS patients .


Asteatotic eczema ( AE ) is characterized by itchy , dry , rough , and scaling skin .


The treatments for AE are mainly emollients , usually containing urea , lactic acid , or a lactate salt .


N-palmitoylethanolamine ( PEA ) and N-acetylethanolamine ( AEA ) are both endogenous lipids used as novel therapeutic tools in the treatment of many skin diseases .


The purpose of this study was to compare a PEA/AEA emollient with a traditional emollient in the treatment of AE .


A monocentric , randomized , double-blind , comparative trial was conducted in @ AE patients to evaluate and compare the efficacy of the two emollients .


The level of skin dryness among the subjects ranged from mild to moderate .


The subjects ' skin barrier function and the current perception threshold were tested for @ days by clinical scoring and bioengineering technology .


The results showed that , although some aspects were improved in both groups , the group using the emollient containing PEA/AEA presented a better skin surface change in capacitance .


However , the most impressive finding was the ability of the PEA/AEA emollient to increase the @ Hz current perception threshold to a normal level after @ days , with a significant difference between values at baseline and after @ days .


A current perception threshold of @ Hz was positively and significantly correlated with skin surface hydration and negatively correlated with transepidermal water loss in the PEA/AEA emollient group .


Compared with traditional emollients , regular application of a topical PEA/AEA emollient could improve both passive and active skin functions simultaneously .


To compare health outcomes during @-year observational follow-up in women initially randomised to unopposed estrogen or placebo .


At recruitment to the Estrogen for the Prevention of Re-Infarction Trial ( ESPRIT ) women were assigned to estradiol valerate : @mg or placebo treatment for @years .


Women were recruited from @ hospitals in the northwest of England and Wales in July @-February @ .


Women aged @-@ surviving their first myocardial infarction .


All women were followed by data linkage to UK mortality and cancer records ; mean follow-up @ and @ years , respectively .


In an intention-to-treat analysis , hazard ratios ( HRs ) were computed , overall and stratified by age at recruitment .


Death ( all-cause , cardiac disease , stroke or cancer ) and cancer incidence ( any , breast or endometrium ) .


There were @ deaths in @ women randomised .


The all-cause mortality HR of @ ( @ % CI @-@ @ ) indicated no significant difference between treatment groups .


Women aged @-@years at recruitment had lower HRs than women aged @-@years for all outcomes except ischaemic heart disease .


Among @ incident cancers there were seven cases of breast cancer in the intervention arm and @ in the placebo ; HR @ ( @ % CI @-@ @ ) .


There were no deaths from endometrial cancer but three incident cases , one in the active arm and two in placebo .


These results suggest that unopposed estrogen may be used safely by women with an intact uterus surviving a first myocardial infarction .


CHA@DS@-VASc and CHADS@ scores were derived and validated for stroke-risk stratification in patients who have a diagnosis of atrial fibrillation ( AF ) .


We hypothesized that these scores would predict adverse cardiovascular events even in the absence of AF .


The CHA@DS@-VASc and CHADS@ scores for @ patients with sick sinus syndrome who underwent pacemaker implantation and were enrolled in the Mode Selection Trial ( MOST ) were calculated .


The association of these risk scores with main trial end points , including the composite of death and stroke , were evaluated to determine whether the associations differed by history of AF .


Of the @ patients , @ % had a CHA@DS@-VASc score of @-@ , @ % had a score of @ , @ % had a score of @-@ , and @ % had a score @ ( the distribution for CHADS@ was similar ) ; @ % had a clinical history of AF .


Both scores were associated with death or stroke ( hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ for each @-point increase in CHA@DS@-VASc ; P = @ ; HR , @ ; @ % CI , @-@ @ for each @-point increase in CHADS@ ; P = @ ) .


Association of scores with outcomes of death , stroke , and heart failure hospitalization were not different for patients with vs those without a history of AF ( interaction P @ for CHA@DS@-VASc and @ for CHADS@ ) .


Both CHA@DS@-VASc and CHADS@ scores predict risk of death or stroke in patients with sick sinus syndrome , regardless of AF history .


These scores could be risk-stratification tools for clinical events that might respond to new therapiesie , anticoagulation or other interventionseven in the absence of AF .


Most acute kidney injury observed in the hospital is defined by sudden mild or moderate increases in the serum creatinine concentration , which may persist for several days .


Such acute kidney injury is associated with lower long-term kidney function .


However , it has not been demonstrated that an intervention that reduces the risk of such acute kidney injury better preserves long-term kidney function .


To characterize the risk of acute kidney injury with an intervention in a randomized clinical trial and to determine if there is a difference between the @ treatment groups in kidney function @ year later .


The Coronary Artery Bypass Grafting Surgery Off - or On-pump Revascularisation Study ( CORONARY ) enrolled @ patients undergoing first isolated coronary artery bypass graft ( CABG ) surgery at @ sites in @ countries .


Patients were randomized to receive CABG surgery either with a beating-heart technique ( off-pump ) or with cardiopulmonary bypass ( on-pump ) .


From January @ to November @ , @ patients ( from @ sites in @ countries ) from CORONARY were enrolled into a kidney function substudy to record serum creatinine concentrations during the postoperative period and at @ year .


The last @-year serum creatinine concentration was recorded on January @ , @ .


Acute kidney injury within @ days of surgery ( @ % increase in serum creatinine concentration from prerandomization concentration ) and loss of kidney function at @ year ( @ % loss in estimated glomerular filtration rate from prerandomization level ) .


Off-pump ( n = @ ) vs on-pump ( n = @ ) CABG surgery reduced the risk of acute kidney injury ( @ % vs @ % , respectively ; relative risk , @ -LSB- @ % CI , @-@ @ -RSB- , P = @ ) ; however , there was no significant difference between the @ groups in the loss of kidney function at @ year ( @ % vs @ % , respectively ; relative risk , @ -LSB- @ % CI , @-@ @ -RSB- , P = @ ) .


Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury or kidney function loss , and in the subgroup with baseline chronic kidney disease .


Use of off-pump compared with on-pump CABG surgery reduced the risk of postoperative acute kidney injury , without evidence of better preserved kidney function with off-pump CABG surgery at @ year .


In this setting , an intervention that reduced the risk of mild to moderate acute kidney injury did not alter longer-term kidney function .


Osteoarthritis ( OA ) of the knee is the most frequent form of arthritis and a cause of pain and disability .


Combined nonpharmacologic and pharmacologic treatments are recommended as the optimal treatment approach , but no evidence supports the recommendation .


To assess the clinical benefits of an intra-articular corticosteroid injection given before exercise therapy in patients with OA of the knee .


We performed a randomized , blinded , placebo-controlled clinical trial evaluating the benefit of intra-articular corticosteroid injection vs placebo injection given before exercise therapy at an OA outpatient clinic from October @ , @ , through April @ , @ .


The participants had radiographic confirmation of clinical OA of the knee , clinical signs of localized inflammation in the knee , and knee pain during walking ( score > @ on a scale of @ to @ ) .


Participants were randomly allocated ( @:@ ) to an intra-articular @-mL injection of the knee with methylprednisolone acetate ( Depo-Medrol ) , @ mg/mL , dissolved in @ mL of lidocaine hydrochloride ( @ mg/mL ) ( corticosteroid group ) or a @-mL isotonic saline injection mixed with @ mL of lidocaine hydrochloride ( @ mg/mL ) ( placebo group ) .


Two weeks after the injections , all participants started a @-week supervised exercise program .


The primary outcome was change in the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire ( range , @-@ ; higher scores indicate greater improvement ) at week @ .


Secondary outcomes included the remaining KOOS subscales and objective measures of physical function and inflammation .


Outcomes were measured at baseline , week @ ( exercise start ) , week @ ( exercise stop ) , and week @ ( follow-up ) .


One hundred patients were randomized to the corticosteroid group ( n = @ ) or the placebo group ( n = @ ) ; @ and @ patients , respectively , completed the trial .


The mean ( SE ) changes in the KOOS Pain subscale score at week @ were @ ( @ ) and @ ( @ ) points in the corticosteroid and placebo groups , respectively , corresponding to a statistically insignificant mean difference of @ points ( @ % CI , -@ to @ ; P = @ ) .


We found no statistically significant group differences in any of the secondary outcomes at any time point .


No additional benefit results from adding an intra-articular injection of @ mg of corticosteroid before exercise in patients with painful OA of the knee .


Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments .


To assess whether a suture technique in upper blepharoplasty may be the cause of differences in the occurrence of suture abscess formation and focal inflammation .


A Level I , randomized controlled trial .


The upper blepharoplasty wound was closed with a running intradermal suture .


External intradermal suturing implied that this suture was started by initially passing it through the intact skin adjacent to the wound .


In contrast , internal intradermal suturing meant the intradermal suture was not started in the adjacent skin but simply within the wound itself .


One week and @ weeks after surgery , the presence of suture abscesses and focal inflammation was assessed at the entrance and exit of the sutures .


After @ week , @ abscesses ( @ % ) were found at the medial side of the externally sutured upper eyelids and @ abscesses ( @ % ) in the internally sutured upper eyelids ( p = @ ) .


The presence of erythema and edema after @ week was also significantly lower in internally sutured upper eyelids ( p = @ ) .


In this series , the method of starting the suture ( internal vs external ) at the medial side of an upper blepharoplasty wound was associated with a statistically significant reduction in the incidence of medial wound inflammation and suture abscess formation at a @-week follow-up .


Adverse skin reactions as a local side effect of nicotine patches sometimes interfere with smoking cessation therapy .


We studied the effects of semipermeable membrane dressings ( SMD ) used under nicotine patches ( NP ) on nicotine absorption , as assessed according to the urinary cotinine levels , and skin symptoms .


First , the urinary cotinine levels were compared in eight nonsmokers that applied NP over SMD and NP without SMD ( Study @ ) .


The urinary cotinine levels were measured using a highly sensitive competitive enzyme immunoassay .


Second , @ subjects undergoing NP therapy for diagnosed nicotine dependence were randomly assigned into two groups in a crossover design to receive NP over SMD and NP without SMD .


The urinary cotinine levels and skin symptoms were compared between the two treatment groups .


During the follow-up period of @ weeks , the smoking cessation rate was evaluated ( Study @ ) .


No statistical differences were observed in the urinary cotinine levels between the NP over SMD and NP without SMD groups .


In Study @ , the skin symptoms improved with the use of SMD in @ % ( @/@ ) of the patients and worsened in @ % ( @/@ ) of the patients .


No serious skin disorders were reported .


The subjects followed in Study @ exhibited smoking cessation rates of @ % , @ % and @ % at @ , @ and @ weeks , respectively .


The use of NP over SMD is a safe and effective alternative application to NP treatment for preventing the skin symptoms caused by NP without interfering with nicotine absorption .


Metal-on-metal ( MOM ) total hip arthroplasties were reintroduced because of the problems with osteolysis and aseptic loosening related to polyethylene wear of early metal-on-polyethylene ( MOP ) arthroplasties .


The volumetric wear rate has been greatly reduced with MOM arthroplasties ; however , because of nano-size wear particles , the absolute number has been greatly increased .


Thus , a source of metal ion exposure with the potential to sensitize patients is present .


We hypothesized that higher amounts of wear particles result in increased release of metal ions and ultimately lead to an increased incidence of metal allergy .


@ hips in @ patients ( median age @ ( @-@ ) years , @ women ) were randomized to either a MOM hip resurfacing system ( ReCap ) or a standard MOP total hip arthoplasty ( Mallory Head/Exeter ) .


Spot urine samples were collected preoperatively , postoperatively , after @ months , and after @ , @ , and @ years and tested with inductively coupled plasma-sector field mass spectrometry .


After @ years , hypersensitivity to metals was evaluated by patch testing and lymphocyte transformation assay .


In addition , the patients answered a questionnaire about hypersensitivity .


A statistically significant @ - to @-fold increase in urinary levels of cobalt and chromium was observed throughout the entire follow-up in the MOM group .


The prevalence of metal allergy was similar between groups .


While we observed significantly increased levels of metal ions in the urine during the entire follow-up period , no difference in prevalence of metal allergy was observed in the MOM group .


However , the effect of long-term metal exposure remains uncertain .


To investigate the effect of pancreatic duct stent internal versus external drainage with pancreaticojejunostomy on the early curative effect after pancreaticoduodenectomy ( PD ) .


The study was a prospective controlled trial .


A total of @ patients undergoing PD from January @ to March @ were randomly divided into external drainage group ( n = @ ) and internal drainage group ( n = @ ) .


The pancreatic duct stent was put in the jejunum during the operation in the internal drainage group , while that in the external drainage group was placed outside the body through the jejunum and abdominal wall .


The intra-operative blood loss , operative duration , post-operative hospital stay , mortality rate , and the morbidity of pancreatic fistula as well as other complications were compared between the two groups .


Compared with internal drainage group , pancreatic duct stent external drainage obviously reduced the morbidity of pancreatic fistula ( @ % vs. @ % ) , delayed gastric emptying ( @ % vs. @ % ) , abdominal infection ( @ % vs. @ % ) , intestinal obstruction ( @ % vs. @ % ) along with the overall complications ( @ % vs. @ % ) after PD ( ( @ ) = @ @ to @ @ , P < @ ) , and shortened the healing duration of pancreatic fistula ( ( @ @ ) d vs. ( @ @ ) d , t = @ , P < @ ) , while there was no significant difference in the intra-operative blood loss , operative duration , post-operative hospital stay and mortality rate , etc between the two groups ( P > @ ) .


Pancreatic duct stent external drainage can effectively reduce the morbidity of pancreatic fistula and the overall complications after PD , which is safe and feasible .


The method is worthy of popularization and application clinically .


Serum sclerostin levels have been reported to be inversely associated with serum @OHD levels , but the effect of vitamin D and calcium supplementation on serum sclerostin levels is unknown .


This study was carried out to determine whether vitamin D and calcium supplementation altered serum sclerostin levels in healthy older adults .


We measured serum sclerostin levels at baseline and after @ years in @ men and women who participated in a placebo-controlled vitamin D ( @IU/day ) and calcium ( @mg/day ) intervention trial carried out in men and women aged @ years .


Serum sclerostin levels were measured using the MesoScale Discovery chemiluminescence assay .


In the men , sclerostin levels increased over @ years by @ ng/l ( @ % ) in the vitamin D plus calcium-supplemented group and decreased by @ ng/l ( @ % ) in the placebo group ( P = @ for difference in change ) .


Adjustments for the season of measurement , baseline physical activity levels , baseline serum sclerostin levels , and total body bone mineral content did not substantially alter the changes .


In the women , there was no significant group difference in change in serum sclerostin levels either before or after the above-mentioned adjustments .


In both the sexes , vitamin D and calcium supplementation significantly increased serum ionized calcium levels and decreased parathyroid hormone levels .


Men and women appear to have different serum sclerostin responses to vitamin D and calcium supplementation .


The reason for this difference remains to be determined .


The research tested the accuracy of the VIVO Harvester software in identifying publications authored by faculty members affiliated with a National Institutes of Health Clinical and Translational Sciences Award ( CTSA ) site .


Health sciences librarians created `` gold standard '' lists of references for the years @ to @ from PubMed for twenty-five randomly selected investigators from one CTSA site .


These gold standard lists were compared to the same twenty-five investigators ' reference lists produced by VIVO Harvester .


The authors subjected the discrepancies between the lists to sensitivity and specificity analyses .


The VIVO Harvester correctly identified only about @ % of the total eligible PubMed references for the years @-@ for the CTSA-affiliated investigators .


The identified references produced by VIVO Harvester were precise yet incomplete .


The sensitivity rate was @ , and the specificity rate was @ .


While the references produced by VIVO Harvester could be confirmed in PubMed , the VIVO Harvester retrieved only two-thirds of the required references from PubMed .


National Institutes of Health CTSA sites will need to supplement VIVO Harvester-produced references with the expert searching skills of health sciences librarians .


Health sciences librarians with searching skills need to alert their CTSA sites about these deficiencies and offer their skills to advance their sites ' missions .


The aim was to evaluate the effect of boceprevir and telaprevir on dolutegravir pharmacokinetics ( PK ) ; the effect of dolutegravir on boceprevir and telaprevir PK was assessed through comparison with historical data for each hepatitisC virus ( HCV ) drug 's prescribing information alone .


This was a single-centre , randomized , open-label , two-cohort , two-period , one-way study in healthy adult subjects .


Dolutegravir @mg once daily was administered for @ days in Period@ , and dolutegravir @mg once daily was coadministered with either boceprevir @mg every @h ( Cohort@ ) or telaprevir @mg every @h ( Cohort@ ) for @days in Period@ .


No deaths or serious adverse events were reported during the study .


Four subjects were withdrawn from the study because of adverse events ( elevated alanine aminotransferase , cellulitis , increased serum creatinine and dizziness ) .


One subject became pregnant during the study .


Coadministration of dolutegravir with boceprevir had no effect on dolutegravir area under the plasma concentration-time curve ( AUC ) and maximal plasma concentration ( Cmax ) and caused a small increase in concentration at the end of the dosing interval ( C ; @ % ) .


Coadministration of dolutegravir with telaprevir resulted in increased dolutegravir plasma exposures compared with those after administration of dolutegravir alone ; AUC@ - , Cmax and C increased by @ , @ and @ % , respectively .


Coadministration of boceprevir or telaprevir with dolutegravir had no clinically significant effect on dolutegravir PK .


Plasma boceprevir and telaprevir PK data for either combined treatment were similar to historical data , indicating no effect of dolutegravir on boceprevir or telaprevir exposure .


Dolutegravir can be coadministered with boceprevir or telaprevir in patients coinfected with HIV and HCV with no dose adjustment .


The blood/gas partition coefficient of a certain volatile anesthetic is of clinical importance because it determines its velocity of uptake into and elimination from the body of a patient and thus its pharmacokinetic behavior .


To date , the blood/gas partition coefficients of isoflurane , sevoflurane , and desflurane have been measured in small numbers of subjects or in particular study groups , for example , healthy volunteers , patients experiencing a common kind of disease , or mothers immediately after giving birth .


The objective of this study was to determine the blood/gas partition coefficients of these volatile anesthetics at @C in a larger clinically relevant and adult patient population .


Furthermore , we tested whether age , gender , body mass index , hemoglobin concentration , or hematocrit had an influence on the coefficients .


Blood samples were taken from @ fasting operative patients with ASA physical status I to III and aged @ to @ years .


All subjects were randomly enrolled in study groups for the separate determinations of the blood/gas partition coefficients of isoflurane ( n = @ ) , sevoflurane ( n = @ ) , and desflurane ( n = @ ) by headspace gas chromatography .


To check the quality of the measurements , we determined the distilled water/gas partition coefficients of those anesthetics and compared them with previously published values .


We found a blood/gas partition coefficient of @ @ ( mean SD ) for isoflurane , @ @ for sevoflurane , and @ @ for desflurane .


Values of this study are @ % , @ % , and @ % higher for isoflurane , sevoflurane , and desflurane , respectively , than the previously published mean values ( all P @ ) .


There were only trends for small correlations between the blood/gas partition coefficient of isoflurane and hemoglobin concentration ( Pearson r = @ ; P = @ ) and hematocrit ( r = @ ; P = @ ) .


We found no other potentially significant correlations of the partition coefficients with patient age , body mass index , hemoglobin concentration , or hematocrit ( all remaining P > @ ) .


Furthermore , the coefficients did not differ significantly between female and male patients .


The evaluation of the distilled water/gas partition coefficients of isoflurane ( @ @ ) , sevoflurane ( @ @ ) , and desflurane ( @ @ ) proved the validity of the gas chromatography method used in this study .


The blood/gas partition coefficients of the modern volatile anesthetics , in particular , those of sevoflurane and desflurane , may be higher than that has been hitherto reported .


Therefore , their uptake and elimination may occur more slowly in some patients than has been supposed .


The blood/gas partition coefficients of isoflurane , sevoflurane , and desflurane measured in this study appear to be representative because they were determined in a clinically and numerically relevant patient cohort .


Physical activity is a key factor for healthy ageing , yet many older people lead a sedentary lifestyle .


Traditional physical activity interventions do not consider the specific needs and views of older adults .


As views on ageing are known to be related to health behaviours , the current study evaluates the effectiveness of prompting positive views on ageing within a physical activity intervention .


Randomised controlled trial with three groups aged @ + : Intervention for physical activity with ` views-on-ageing ' - component ( n = @ ; IGVoA ) , and without ` views-on-ageing ' - component ( n = @ ; IG ) , and active control intervention for volunteering ( n = @ ; CG ) .


Attitudes towards older adults and physical activity were assessed five weeks before intervention , two weeks , six weeks and @ months after the intervention .


Compared to the IG and CG , positive attitudes towards older adults increased in the IGVoA after the intervention .


For IGVoA , the indirect intervention effect on change in activity via change in attitudes towards older adults was reliable .


A ` views-on-ageing ' - component within a physical activity intervention affects change in physical activity via change in views on ageing .


Views on ageing are a promising intervention technique to be incorporated into future physical activity interventions for older adults .


Evaluate a selective obesity prevention program promoting use of cognitive reappraisals to reduce reward region response and increase inhibitory region response to high-fat/high-sugar foods and reduce intake of fat and sugar to prevent blunted reward region response to intake of such foods .


Young adults at risk for future weight gain by virtue of weight concerns ( N = @ ) were randomized to this new prevention program ( Minding Health ) , an alternative prevention program promoting participant-driven gradual reductions in caloric intake and increases in physical activity ( Healthy Weight ) , or an obesity education video control condition , completing assessments at pre - , post - , and @-month follow-up .


A subset of Minding Health and control participants completed an fMRI scan at pre - and post-assessing neural response to images of high-fat/sugar foods and to receipt and anticipated receipt of a high-fat/sugar food .


Minding Health participants showed significantly greater reductions in body fat than controls and caloric intake from fat and sugar than Healthy Weight participants .


Minding Health participants also showed greater activation of an inhibitory control region and reduced activation of an attention/expectation region in response to palatable food images relative to pretest and controls .


However , Healthy Weight participants showed greater reductions in BMI and eating disorder symptoms than Minding Health participants .


Although the Minding Health intervention produced some of the hypothesized effects , it did not produce lasting reductions in body fat or BMI and showed limited effects on neural responsivity , implying it will be vital to increase the efficacy of this new prevention program .


Sixty-two percent of patients would like their doctor to recommend a specific web site to find health information , but only @ % of patients receive such recommendations .


We investigated whether providing patients with an Internet web-site link recommended by their physician would improve patient knowledge and satisfaction .


Our hypothesis was that directing patients to a reliable web site would improve both .


Sixty patients with a new diagnosis of carpal tunnel syndrome were prospectively randomized into two groups .


Twenty-three patients in the control group had a traditional physician office visit and received standard care for carpal tunnel syndrome .


Thirty-seven patients in the treatment group received a handout that directed them to the American Society for Surgery of the Hand ( ASSH ) web page on carpal tunnel syndrome in addition to the standard care provided in the office visit .


Patients later completed a ten-question true-or-false knowledge questionnaire and a six-item satisfaction survey .


Differences in scores were analyzed using two-sample t tests .


Less than half ( @ % ) of the patients who were given the Internet directive reported that they had visited the recommended web site .


The mean scores on the knowledge assessment ( @ of @ for the treatment group and @ of @ for the control group ) and the satisfaction survey ( @ of @ for the treatment group and @ of @ for the control group ) were similar for both groups .


The mean score for knowledge was similar for the patients who had used the ASSH web site and for those who had not ( @ and @ respectively ) .


Moreover , compared with patients who had not used the Internet at all to learn about carpal tunnel syndrome , patients who used the Internet scored @ % better ( mean score , @ for those who used the Internet compared with @ for those who had not ; p > @ ) .


Regardless of Internet usage , most patients scored well on the knowledge assessment and reported a high level of satisfaction .


Whether the patient was given a handout or had visited the ASSH or other Internet web sites , the knowledge and satisfaction scores for all patients were similar .


Since the physician was the common denominator in both groups , the results indicate that the patient-physician relationship may be more valuable than the Internet in providing patient education .


Effective communication between patients and practitioners is at the cornerstone of delivering excellent care and building trusting relationships .


This study examines whether reliable Internet information should be embraced as a tool to enhance patient-surgeon communication in a clinical context .


Indigenous children in high-income countries have a heavy burden of bronchiectasis unrelated to cystic fibrosis .


We aimed to establish whether long-term azithromycin reduced pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease .


Between Nov @ , @ , and Dec @ , @ , we enrolled Indigenous Australian , Maori , and Pacific Island children aged @-@ years with either bronchiectasis or chronic suppurative lung disease into a multicentre , double-blind , randomised , parallel-group , placebo-controlled trial .


Eligible children had had at least one pulmonary exacerbation in the previous @ months .


Children were randomised ( @:@ ratio , by computer-generated sequence with permuted block design , stratified by study site and exacerbation frequency -LSB- @-@ vs @ episodes in the preceding @ months -RSB- ) to receive either azithromycin ( @ mg/kg ) or placebo once a week for up to @ months .


Allocation concealment was achieved by double-sealed , opaque envelopes ; participants , caregivers , and study personnel were masked to assignment until after data analysis .


The primary outcome was exacerbation ( respiratory episodes treated with antibiotics ) rate .


Analysis of the primary endpoint was by intention to treat .


At enrolment and at their final clinic visits , children had deep nasal swabs collected , which we analysed for antibiotic-resistant bacteria .


This study is registered with the Australian New Zealand Clinical Trials Registry ; ACTRN@ .


@ children were assigned to azithromycin and @ to placebo .


The study was stopped early for feasibility reasons on Dec @ , @ , thus children received the intervention for @-@ months .


The mean treatment duration was @ months ( SD @ ) , with a total of @ child-months in the azithromycin group and @ child-months in the placebo group .


Compared with the placebo group , children receiving azithromycin had significantly lower exacerbation rates ( incidence rate ratio @ ; @ % CI @-@ ; p < @ ) .


However , children in the azithromycin group developed significantly higher carriage of azithromycin-resistant bacteria ( @ of @ , @ % ) than those receiving placebo ( four of @ , @ % ; p = @ ) .


The most common adverse events were non-pulmonary infections ( @ of @ events in the azithromycin group vs @ of @ events in the placebo group ) and bronchiectasis-related events ( episodes or investigations ; @ of @ events in the azithromycin group vs @ of @ events in the placebo group ) ; however , study drugs were well tolerated with no serious adverse events being attributed to the intervention .


Once-weekly azithromycin for up to @ months decreased pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease .


However , this strategy was also accompanied by increased carriage of azithromycin-resistant bacteria , the clinical consequences of which are uncertain , and will need careful monitoring and further study .


To examine whether insulin glargine can lead to better control of glycated haemoglobin ( HbA@c ) than that achieved by neutral protamine Hagedorn ( NPH ) insulin , using a protocol designed to limit nocturnal hypoglycaemia .


The present study , the Least One Oral Antidiabetic Drug Treatment ( LANCELOT ) Study , was a @-week , randomized , open-label , parallel-arm study conducted in Europe , Asia , the Middle East and South America .


Participants were randomized ( @:@ ) to begin glargine or NPH , on background of metformin with glimepiride .


Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels @ mmol/l , while limiting values @ mmol/l .


The efficacy population ( n = @ ) had a mean age of @ years , a mean body mass index of @ kg/m , a mean duration of diabetes of @ years and a mean HbA@c level of @ % ( @mmol/mol ) .


At treatment end , HbA@c values and the proportion of participants with HbA@c < @ % ( < @mmol/mol ) were not significantly different for glargine -LSB- @ % ( @mmol/mol ) and @ % -RSB- versus NPH -LSB- @ % ( @mmol/mol ) and @ % -RSB- .


The rate of symptomatic nocturnal hypoglycaemia , confirmed by plasma glucose @ or @ mmol/l , was @ and @ % less with glargine than with NPH insulin .


Other outcomes were similar between the groups .


Insulin glargine was not superior to NPH insulin in improving glycaemic control .


The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins .


This study confirms , in a globally heterogeneous population , the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH , even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels .


Vaccines against norovirus , the leading cause of acute gastroenteritis , should protect against medically significant illness and reduce transmission .


In this randomized , double-blind , placebo-controlled trial , @ - to @-year-olds received @ injections of placebo or norovirus GI @ / GII @ bivalent vaccine-like particle ( VLP ) vaccine with @-O-desacyl-@ ' - monophosphoryl lipid A ( MPL ) and alum .


Participants were challenged as inpatients with GII @ virus ( @ reverse transcription polymerase chain reaction -LSB- RT-PCR -RSB- units ) , and monitored for illness and infection .


Per protocol , @ of @ ( @ % ) vaccinees and @ of @ ( @ % ) controls were infected .


Using predefined illness and infection definitions , vaccination did not meet the primary endpoint , but self-reported cases of severe ( @ % vaccinees vs. @ % controls ; P = @ ) , moderate or greater ( @ % vs. @ % ; P = @ ) , and mild or greater severity of vomiting and/or diarrhea ( @ % vs. @ % ; P = @ ) were less frequent .


Vaccination also reduced the modified Vesikari score from @ to @ ( P = @ ) .


Difficulties encountered were low norovirus disease rate , and inability to define illness by quantitative RT-PCR or further antibody rise in vaccinees due to high vaccine-induced titers .


By day @ , @ of @ ( @ % ) vaccinees were shedding virus compared with @ of @ ( @ % ) placebo recipients ( P = @ ) .


Bivalent norovirus VLP vaccine reduced norovirus-related vomiting and/or diarrhea ; field efficacy studies are planned .


Clinical Trials Registration .


NCT@ .


Amphetamine challenge in rodent prepulse inhibition ( PPI ) studies has been used to model potential dopamine involvement in effects that may be relevant to schizophrenia , though similar studies in healthy humans have failed to report replicable or robust effects .


The present study investigated dexamphetamine effects on PPI in healthy humans with an increased dose and a range of startling stimulus intensities to determine participants ' sensitivity and range of responses to the stimuli .


A randomised , placebo-controlled dexamphetamine ( @ mg/kg , per os . )


, double-blind , counterbalanced , within-subject design was used .


PPI was measured in @ participants across a range of startling stimulus intensities , during two attention set conditions ( ATTEND and IGNORE ) .


Startle magnitudes for pulse-alone and prepulse-pulse magnitudes were modelled using the startle reflex magnitude ( sigmoid ) function .


Parameters were extracted from these fits , including the upper limit of the asymptote ( maximum startle reflex capacity , R MAX ) , intensity threshold , stimulus intensity that elicits a half-maximal response ( ES@ ) and the maximum rate of change of startle response magnitude to an increase in stimulus intensity .


Dexamphetamine increased the threshold and ES@ of the response to pulse-alone trials in both sexes and reduced R MAX exclusively in females .


Dexamphetamine modestly increased PPI of the R MAX across both attention conditions .


PPI of R MAX was reduced during the ATTEND condition compared to the IGNORE condition .


Results indicate that sex differences exist in motor , but not sensory , components of the startle reflex .


Findings also reveal that administration of @ mg/kg dexamphetamine to healthy humans does not mimic PPI effects observed in schizophrenia .


Corticosteroid withdrawal ( CW ) after pediatric kidney transplantation potentially improves growth while avoiding metabolic and other adverse events .


We have recently reported the results of a @ subject randomized controlled trial comparing early CW ( tacrolimus , mycophenolate mofetil ( MMF ) , daclizumab , and corticosteroids until day @ ) with tacrolimus , MMF , and corticosteroid continuation ( CC ) .


At @ months , CW subjects showed better growth with no adverse impact on acute rejection or graft survival ( Am J Transplant @ ; @ : @-@ ) .


This @-year investigator-driven follow-up study aimed to determine whether improved growth persisted in the longer term .


Data regarding growth , graft outcomes and adverse events were collected at @ year ( @ patients ) and @ years ( @ patients ) after transplantation .


The primary endpoint , longitudinal growth calculated as delta height standard deviation score , was analyzed using a mixed model repeated measures model .


Corticosteroid withdrawal subjects grew better at @ year ( difference in adjusted mean change , @ ; @ % confidence interval , @ , @ ; P = @ ) .


At @ years , growth remained numerically better in CW subjects ( @ ( -@ , @ ) ; P = @ ) , and significantly better in prepubertal subjects ( @ ( @ , @ ) ; P = @ ) .


Bacterial and viral infection was significantly more common in CW subjects at @ year only .


Corticosteroid withdrawal and CC subjects received similar exposure to both tacrolimus and MMF at @ and @ years .


No significant difference in patient or graft survival , rejection , estimated glomerular filtration rate , or other adverse events was detected .


Early CW effectively and safely improves growth up to @ years after transplantation , particularly in prepubertal children .


Persistent eosinophilic airway inflammation in asthma increases the risk of exacerbations .


In a phase @b dose-ranging study , we aimed to assess the efficacy and safety of benralizumab , an anti-interleukin @ receptor monoclonal antibody that depletes blood and airway eosinophils , in adults with uncontrolled eosinophilic asthma .


We did a randomised , controlled , double-blind , dose-ranging phase @b study .


Eligible participants were adults aged @-@ years with uncontrolled asthma using medium-dose or high-dose inhaled corticosteroids and longacting agonists , with two to six exacerbations in the past year .


Current or former smokers were excluded .


We used the ELEN index ( an algorithm to predict elevated sputum eosinophils ) or baseline fraction of exhaled nitric oxide to stratify patients by eosinophilic status , and with an interactive web-voice response system randomly assigned eosinophilic individuals in a @:@:@:@ ratio to receive placebo , @ mg benralizumab , @ mg benralizumab , or @ mg benralizumab , and non-eosinophilic individuals in a @:@ ratio to receive placebo or @ mg benralizumab .


Study drugs were given as two subcutaneous injections every @ weeks for the first three doses , then every @ weeks , for @ year .


Patients , treating physicians , and study investigators were masked to treatment allocation .


The primary endpoint was annual exacerbation rate in eosinophilic individuals after @ year of follow-up .


Analysis was by modified intention to treat .


This study was designed with a two-sided of @ and powered at @ % for the primary outcome in the eosinophilic population .


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


Between Jan @ , @ , and March @ , @ , we randomly assigned @ eosinophilic individuals to placebo ( n = @ ) or benralizumab @ mg dose ( n = @ ) , @ mg dose , ( n = @ ) , or @ mg dose ( n = @ ) , and @ non-eosinophilic individuals to @ mg benralizumab ( n = @ , @ included in analysis ) or placebo ( n = @ , @ included in analysis ) .


In eosinophilic individuals , benralizumab reduced exacerbation rates compared with placebo in the @ mg group ( @ vs @ , reduction @ % , @ % CI @ to @ , p = @ ) but not in the @ mg group ( @ vs @ , difference -@ % , @ % CI -@ to @ , p = @ ) or the @ mg group ( @ vs @ , reduction @ % , @ % CI @ to @ , p = @ ) .


In patients with a baseline blood eosinophil cutoff of at least @ cells per L , exacerbation rates in the benralizumab @ mg group ( n = @ ) and @ mg group ( n = @ ) were lower than in the placebo group ( n = @ ; @ vs @ , reduction @ % , @ % CI @ to @ , p = @ for @ mg dose ; @ vs @ , difference @ % , @ % CI @ to @ , p = @ for @ mg dose ) .


Our findings suggested that benralizumab @ mg and @ mg resided at the dose-response plateau .


Treatment-emergent adverse events occurred in @ ( @ % ) of @ participants receiving any benralizumab dose compared with @ ( @ % ) of @ receiving placebo .


Nasopharyngitis ( @ -LSB- @ % -RSB- patients receiving benralizumab vs @ -LSB- @ % -RSB- patients receiving placebo ) and injection site reactions ( @ -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) occurred more frequently with benralizumab than with placebo .


Benralizumab at @ mg and @ mg doses seemed to reduce asthma exacerbations in adults with uncontrolled eosinophilic asthma and baseline blood eosinophils of at least @ cells per L , possibly due to targeting of the interleukin @ receptor rather than interleukin @ ligand .


Further investigation of benralizumab treatment in phase @ studies is warranted .


We evaluated @ methods of integrating interventions for depression ( Adolescent Coping With Depression Course ; CWD ) and substance use disorders ( Functional Family Therapy ; FFT ) , examining ( a ) treatment sequence effects on substance use and depression outcomes and ( b ) whether the presence of major depressive disorder ( MDD ) moderated effects .


Participants were @ adolescents ( ages @-@ ; @ % female ; @ % non-Hispanic White ) with comorbid depressive disorder ( @ % MDD , @ % dysthymia ) and substance use disorders who were randomized to ( a ) FFT followed by CWD ( FFT/CWD ) , ( b ) CWD followed by FFT ( CWD/FFT ) , or ( c ) coordinated FFT and CWD ( CT ) .


Acute treatment ( @ treatment sessions provided over @ weeks ) and @ - and @-month follow-up effects are presented for substance use ( percentage of days of substance use ; Timeline Followback ) and depression ( Children 's Depression Rating Scale-Revised ) .


FFT/CWD achieved better substance use outcomes than CT at posttreatment , and @ - and @-month follow-ups ; substance use effects for CWD/FFT were intermediate .


For participants with baseline MDD , the CWD/FFT sequence resulted in lower substance use than either FFT/CWD or CT. .


Depressive symptoms decreased significantly in all @ treatment sequences with no evidence of differential effectiveness during or following treatment .


Attendance was lower for the second of both sequenced interventions .


A large proportion of the sample received treatment outside the study , which predicted better outcomes in the follow-up .


Depression reductions occurred early in all @ treatment sequences .


Of the examined treatment sequences , FFT/CWD appeared most efficacious for substance use reductions but addressing depression early in treatment may improve substance use outcomes in the presence of MDD .


Drug development in chronic obstructive pulmonary disease ( COPD ) has been characterised by unacceptably high failure rates .


In addition to the poor sensitivity in forced expiratory volume in one second ( FEV@ ) , numerous causes are known to contribute to this phenomenon , which can be clustered into drug - , disease - and design-related factors .


Here we present a model-based approach to describe disease progression , treatment response and dropout in clinical trials with COPD patients .


Data from six phase II trials lasting up to @ months were used .


Disease progression ( trough FEV@ measurements ) was modelled by a time-varying function , whilst the treatment effect was described by an indirect response model .


A time-to-event model was used for dropout


All relevant parameters were characterised with acceptable precision .


Two parameters were necessary to model the dropout patterns , which was found to be partly linked to the treatment failure .


Disease severity at baseline , previous use of corticosteroids , gender and height were significant covariates on disease baseline whereas disease severity and reversibility to salbutamol/salmeterol were significant covariates on Emax for salmeterol active arm .


Incorporation of the various interacting factors into a single model will offer the basis for patient enrichment and improved dose rationale in COPD .


To evaluate the efficacy and safety of domestically produced Salbutamol Sulfate metered dose inhaler ( MDI ) without chloro-fluro-carbon ( CFC ) in the treatment of asthmatic patients .


A muticenter , randomized , double-blind , positive controlled clinical trial was conducted in asthmatic patients .


The participants were randomized divided into trial group treated with domestically produced Salbutamol Sulfate Aerosol MDI ( @ microg single-dose ) and control group treated with imported Salbutamol Sulfate Aerosol MDI ( @ microg single-dose ) .


The lung function was measured by spirometry and a scoring questionaire before medications and @ , @ , @ and @ min post medications .


A total of @ patients were enrolled in the trial .


Compared with baselines , the forced expiratory volume in @ s ( FEV@ ) of the participants in both groups increased significantly @ , @ , @ and @ min after medications ( P < @ ) .


There was no significant difference in the changes of FEV@ between the two groups ( P > @ ) .


Similarly , the forced vital capacity ( FVC ) and asthma symptomatic scores of the participants in both groups improved significantly after administration of medications ( P < @ ) .


There was no significant difference in the ratio of adverse reactions between the two groups ( P > @ ) .


In both groups , drugs were well tolerated .


The domestically produced Salbutamol Sulfate Aerosol MDI without CFC is effective and safe for treating asthma .


The effect of single low-dose dexamethasone therapy on perioperative blood glucose concentrations has not been well characterized .


In this investigation , we examined the effect of @ commonly used doses of dexamethasone ( @ and @ mg at induction of anesthesia ) on blood glucose concentrations during the first @ hours after administration .


Two hundred women patients were randomized to @ of @ groups : Early-control ( saline ) ; Early-@ mg ( @ mg dexamethasone ) ; Early-@ mg ( @ mg dexamethasone ) ; Late-control ( saline ) ; Late-@ mg ( @ mg dexamethasone ) ; and Late-@ mg ( @ mg dexamethasone ) .


Blood glucose concentrations were measured at baseline and @ , @ , @ , and @ hours after administration in the early groups and at baseline and @ and @ hours after administration in the late groups .


The incidence of hyperglycemic events ( the number of patients with at least @ blood glucose concentration > @ mg/dL ) was determined .


Blood glucose concentrations increased significantly over time in all control and dexamethasone groups ( from median baselines of @ to @ mg/dL to maximum medians ranging from @ to @ mg/dL , all P < @ ) .


Blood glucose concentrations did not differ significantly between the groups receiving dexamethasone ( either @ or @ mg ) and those receiving saline at any measurement time .


The incidence of hyperglycemic events did not differ in any of the early ( @ % -@ % , P = @ ) or late ( @ % -@ % , P = @ ) groups .


Because blood glucose concentrations during the first @ hours after administration of single low-dose dexamethasone did not differ from those observed after saline administrations , these results suggest clinicians need not avoid using dexamethasone for nausea and vomiting prophylaxis out of concerns related to hyperglycemia .


Nausea and vomiting can occur in Parkinson 's disease ( PD ) patients initiated on apomorphine subcutaneous injections and antiemetic prophylaxis is recommended per product labeling .


Data suggest long-term antiemetic prophylaxis may not be needed , although this has not been systematically studied .


We evaluated coadministered trimethobenzamide with apomorphine in @ PD subjects using a randomized , double-blind , placebo-controlled design , with phased withdrawal of subjects from trimethobenzamide to placebo .


Evaluations included presence/absence of nausea and vomiting ; Index of Nausea , Vomiting , and Retching ( INVR ) ; subject evaluation of medication ; Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor score ; `` on '' response post-injection ; and safety assessments .


Incidence of nausea and/or vomiting on Day @ of apomorphine initiation ( primary endpoint ) was not significantly different between trimethobenzamide and placebo .


Over a longer period , a significantly lower incidence was found for trimethobenzamide during Period @ ( Days @-@ , p = @ ) and Period @ ( Days @-@ , p = @ ) , with no difference during Period @ ( Days @-@ ) .


INVR results were generally more favorable with trimethobenzamide than placebo in Period @ and significantly more favorable in Period @ .


The majority of subjects in both groups achieved an `` on '' response after apomorphine injection at all assessments .


No significant differences were found between groups for UPDRS motor scores .


No added safety risk with concomitant use of trimethobenzamide and apomorphine was found .


Our data suggest that trimethobenzamide helps reduce nausea/vomiting during the first @ weeks of apomorphine therapy , but is generally not needed thereafter .


Trimethobenzamide did not worsen parkinsonism nor affect `` on '' response after apomorphine injection .


To evaluate the association between outdoor and nearwork activities at baseline and myopia stabilisation by age @ in the Correction of Myopia Evaluation Trial ( COMET ) .


Correction of Myopia Evaluation Trial enrolled @ children ( ages : @-@years ) with spherical equivalent myopia between -@ and -@ D , who were randomised to progressive addition or single vision lenses and followed for @years in their original lenses .


At baseline , families recorded the child 's outdoor and nearwork activities for @days within a week .


Weekly hours spent in nearwork and outdoor activities were calculated for each participant .


Refractions collected over @years were fit using the Gompertz function to determine each participant 's myopia stabilisation age .


Myopia for each child was then categorized as stable/not stable by age @ .


Half ( @/@ ) of participants had usable baseline activity diaries and refraction data that could be fit with the Gompertz function , @ % ( @/@ ) had stable myopia by age @ and @ % had myopia that was not yet stable .


The frequency of stable myopia was similar for the two categories ( median split ) of outdoor activities : @ % ( @/@ ) for @ hours/week ( -@ ) and @ % ( @/@ ) for > @ hours/week ( -@ ) .


@ % ( @/@ ) of children reporting > @ h of baseline weekly nearwork activity had stable myopia by age @ compared to @ % ( @/@ ) with @ h of near work ( adjusted OR = @ ; @ % CI : @-@ @ ) .


Using baseline nearwork as a continuous variable , the multivariable odds ratio for the association between baseline nearwork hours and stabilisation by age @ is @ : @ % CI : @-@ @ , a result trending towards significance .


While time spent in outdoor activities in childhood does not appear to be related to myopia stabilisation by age @ , less near work activity might potentially be associated with myopia stabilisation by that age .


The long-term safety and therapeutic response of sodium oxybate ( SXB ) in fibromyalgia syndrome ( FM ) patients were assessed for a combined period of up to @ year in a prospective , multicenter , open-label , extension study in patients completing @ of @ phase @ randomized , double-blind , controlled , @-week trials that examined the efficacy and safety of SXB @ g , SXB @ g , and placebo for treatment of FM .


This extension study comprised an additional @ weeks of treatment and was carried out at @ clinical sites in @ countries .


Initial entry criteria for the previous @ double-blind clinical trials required that patients aged @ years met the American College of Rheumatology @ criteria for FM , had a body mass index ( BMI ) < @ kg/m@ , and had a score @ on a @-mm pain visual analog scale ( VAS ) at baseline .


All patients began treatment in the extension study with SXB @ g/night ( administered in @ equally divided doses ) for at least @ week , followed by possible serial @ g/night dose increases to @ g/night ( maximum ) or reductions to @ g/night ( minimum ) .


Of the @ FM patients enrolled in this extension study , @ ( @ % ) completed the study .


The main reason for early discontinuation was adverse events ( AEs ; @ % of patients ) .


Patients were primarily middle-aged ( mean @ years ) , female ( @ % ) , white ( @ % ) , with a mean duration of FM symptoms of @ years .


Serious AEs were experienced by @ % of patients .


The most frequently reported AEs ( incidence @ % at any dose or overall ) were nausea , headache , dizziness , nasopharyngitis , vomiting , sinusitis , diarrhea , anxiety , insomnia , influenza , somnolence , upper respiratory tract infection , muscle spasms , urinary tract infection , and gastroenteritis viral .


Maintenance of SXB therapeutic response was demonstrated with continued improvement from controlled-study baseline in pain VAS , Fibromyalgia Impact Questionnaire ( FIQ ) total scores , and other measures .


Responder analyses showed that @ % of patients achieved @ % reduction in pain VAS and @ % achieved @ % reduction in FIQ total score at study endpoint .


The long-term safety profile of SXB in FM patients was similar to that in the previously reported controlled clinical trials .


Improvement in pain and other FM clinical domains was maintained during long-term use .


To evaluate the efficacy of the stair-step protocol using clomiphene citrate ( CC ) and to assess the uterine and systemic side effects in patients with polycystic ovary syndrome ( PCOS ) .


A total of @ PCOS patients who failed to respond to @mg/day for @days of CC treatment within the cycle were randomly allocated to the control ( traditional protocol ) and study ( stair-step protocol ) groups .


In the stair-step protocol , patients were treated with CC @mg/day for @days and then in nonresponsive patients , the dosage was increased to @mg/day for @days in the same cycle .


Patients who failed the @mg/day CC treatment in the previous cycle were stimulated with @mg/day CC and were accepted as the control group .


Ovulation and pregnancy rates , duration of treatment and uterine and systemic side effects were evaluated .


Ovulation and pregnancy rates were similar between the stair-step and the control group ( @ vs. @ % , respectively ) ( @ vs. @ % , respectively ) .


The duration of treatment was significantly shorter in stair-step compared to traditional protocol ( @ vs. @ days , respectively ) .


There were no significant differences in the systemic side effects between the groups .


Uterine side effects were evaluated with endometrial thickness and uterine artery Doppler ultrasound ; no significant differences were observed in stair-step compared to traditional protocol .


The stair-step protocol was determined to have a significantly shorter treatment period without any detrimental effect on the ovulation and pregnancy rates .


Patient blood management combines the use of several transfusion alternatives .


Integrated use of erythropoietin , cell saver , and/or postoperative drain reinfusion devices on allogeneic erythrocyte use was evaluated using a restrictive transfusion threshold .


In a factorial design , adult elective hip - and knee-surgery patients with hemoglobin levels @ to @ g/dl ( n = @ ) were randomized for erythropoietin or not , and subsequently for autologous reinfusion by cell saver or postoperative drain reinfusion devices or for no blood salvage device .


Primary outcomes were mean allogeneic intra - and postoperative erythrocyte use and proportion of transfused patients ( transfusion rate ) .


Secondary outcome was cost-effectiveness .


With erythropoietin ( n = @ ) , mean erythrocyte use was @ units ( U ) / patient and transfusion rate @ % while without ( n = @ ) , these were @ U/patient and @ % , respectively .


Consequently , erythropoietin resulted in a nonsignificant @ % mean erythrocyte reduction ( ratio , @ ; @ % CI , @ to @ ) and @ % reduction of transfused patients ( odds ratio , @ ; @ % CI , @ to @ ) .