The target group showed a trend of improvement six months after stroke that was not present in the control group .


FPCA is a method which may be used to provide greater insight into the analysis of the rehabilitation process than that provided by conventional parametric methods .


So , by using the whole curves as basic data parameters , subtle differences in the rehabilitation process can be found.FPCA represents a future aid for the fine analysis of similar physiotherapy techniques , when applied in subjects with a huge variability of functional recovery , as in the case of post-stroke patients .


There is a growing interest in food constituents that could reduce intestinal glucose absorption to prevent overshooting plasma glucose and insulin levels in patients with prediabetes and diabetes mellitus type @ .


We here demonstrate that an extract and individual polyphenols from apple diminish sodium-coupled glucose transporter @ ( SGLT@ ) mediated glucose uptake in vitro and in vivo .


Inhibition of transport of sugars by SGLT@ was shown in Xenopus oocytes and in mice jejunal segments .


Strongest inhibition was observed for phlorizin with IC@ values for transport inhibition of @ @ and @ @ M in oocytes and intestinal segments , respectively .


An oral glucose tolerance test performed in volunteers with prior administration of the apple extract reduced venous blood glucose and plasma insulin levels , similar to findings obtained in C@BL/@N mice .


Analysis of human urine samples revealed that the extract increased modestly renal glucose loss that is most likely a result of inhibition of renal glucose reabsorption by phloretin derivatives found in plasma of the volunteers .


Although the apple extract substantially decreased intestinal glucose absorption in all test systems , the finding that there are systemic effects that relate to inhibition of glucose transport processes beyond the intestine addresses safety issues that need further exploitation .


Hypertrophic scar development after median sternotomy wound in cardiac surgery patients is quite common in surgical practice and becomes a major concern nowadays .


To compare cosmetic outcome between different suture materials and different suture techniques for skin closure in median sternotomy wound .


A randomized clinical trial was conducted in @ patients who underwent cardiac surgery in Thammasat University Hospital , Thailand .


In respect of the materials and the techniques used to suture the skin , the patients were randomly allocated to four groups .


In group @ , the skin was closed with subcuticular running @-@ Poliglecaprone @ ( Monocryl ) .


In group @ , the skin was closed with subcuticular running @-@ Polydioxanone ( PDS ) .


In group @ , the skin was closed with subcuticular running @-@ Poliglecaprone @ ( Monocryl ) and running horizontal mattress @-@ Nylon .


In group @ , the skin was closed with subcuticular running @-@ Polydioxanone ( PDS ) and running horizontal mattress @-@ Nylon .


Postoperative evaluation was performed at @ and @ weeks , @ and @ months follow-up visits .


The scar was analyzed in three parts : upper , middle and lower one third of the sternal wound .


The outcome measures for surgical wound were width , height and overall appearance of the scar using the Vancouver scar scale ( VSS ) .


A linear visual analogue score ( VAS ) was preformed to assess pain and itch .


At @ months , there were no significant differences between @ groups ofpatients in every parameters ( width , height , VSS , pain score and itch score ) at three different wound sites ( upper middle and lower ) .


There was a statistically significant and progressive increase in scar stretching , height and total VSSfrom top to bottom of the sternum with the same pattern in all groups ofpatients ( p < @ ) .


At @ months , scar showed a statistically significant difference in width when compares to@ weeks and @ months ( p < O. @ ) .


Female had a statistically significant difference ofscar stretching at upper two third of the sternum ( p < @ ) .


Female scar width was approximately @folds greater than male patient .


Duringfollow-up in group @ , two patients died postoperatively due to multi-organ failure and one patient developed wound infection .


There were no significant differences in cosmetic outcomes between different suture materials and different suture techniques .


This study was conducted to evaluate the effects of daily consumption of synbiotic bread on the metabolic status of patients with type @ diabetes mellitus .


This randomized , double-blind , controlled clinical trial was performed in @ diabetic patients .


The subjects were randomly assigned to consumption of synbiotic ( n = @ ) , probiotic ( n = @ ) , or control bread ( n = @ ) for @ weeks @ times a day in a @-gram package .


The synbiotic bread contained Lactobacillus sporogenes ( @ @ ( @ ) CFU ) and @ g inulin per @ g.


The probiotic bread contained L. sporogenes ( @ @ ( @ ) CFU per @ g ) .


Fasting blood samples were taken at baseline and after an @-week intervention for quantification of related factors .


Consumption of the synbiotic bread resulted in a significant reduction in serum insulin levels ( -@ @ vs. -@ @ and @ @ IU/ml , respectively , p = @ ) , homeostatic model assessment for insulin resistance scores ( -@ @ vs. -@ @ and @ @ , respectively , p = @ ) , and homeostatic model assessment -- cell function ( -@ @ vs. -@ @ and @ @ , respectively , p = @ ) compared to the probiotic and control breads .


We did not find any significant effect of synbiotic bread consumption on fasting plasma glucose , the quantitative insulin sensitivity check index , or serum hs-CRP levels compared to other breads .


Consumption of the synbiotic bread among diabetic patients had beneficial effects on insulin metabolism .


Hypertension is an important issue in Asia , responsible for up to @ % of cardiovascular disease cases .


This randomized controlled trial subgroup analysis compared telmisartan @ mg ( T@ ) / hydrochlorothiazide @ mg ( H@ ) singlepill combination with T@ monotherapy , specifically in Chinese and Korean patients .


Patients with grade @/@ hypertension were randomized to receive telmisartan @ mg ( T@ ) / hydrochlorothiazide @ mg ( H@ @ ) combination or T@ monotherapy for one week , before uptitrating the dose to T@/H@ or T@ , respectively , for the remaining @ weeks .


The primary endpoint was systolic blood pressure ( SBP ) mean change from baseline .


Secondary endpoints included mean diastolic blood pressure ( DBP ) change from baseline , and blood pressure ( BP ) goal achievement .


Adverse events were recorded .


Of a total @ patients who were treated , efficacy analyses for Chinese and Korean patients included @ patients treated with T@/H@ and @ patients treated with T@ .


At week @ , mean SBP reductions from baseline were -@ mmHg ( @ mmHg = @ kPa ) and -@ mmHg in the T@/H@ and T@ groups ( adjusted mean difference , -@ mmHg ; @ % confidence interval ( CI ) , -@ to -@ ) .


Mean DBP reductions were -@ and -@ mmHg in the T@/H@ and T@ groups ( adjusted mean difference , -@ mmHg ; @ % CI , -@ to -@ ) .


In total , @ % of patients receiving T@/H@ achieved BP goal ( < @/@ mmHg ) compared with @ % receiving T@ .


SBP goal attainment ( < @ mmHg ) and DBP goal attainment ( < @ mmHg ) were also higher in the T@/H@ group compared with the T@ group ( SBP : @ % vs. @ % ; DBP : @ % vs. @ % ) .


A small number of treatment-related adverse events were observed in both T@/H@ ( nine patients , @ % ) and T@ monotherapy ( two patients , @ % ) groups .


In Chinese and Korean patients with moderate-to-severe hypertension , treatment with T@/H@ provided large reductions in mean SBP and DBP , and high BP goal attainment rates .


This once-daily combination is effective and well tolerated in this patient group .


High density lipoproteins ( HDL ) have many cardioprotective roles ; however , in subjects with type @ diabetes ( T@D ) these cardioprotective properties are diminished .


Conversely , increased fruit and vegetable ( F&V ) intake may reduce cardiovascular disease risk , although direct trial evidence of a mechanism by which this occurs in subjects with T@D is lacking .


Therefore , the aim of this study was to examine if increased F&V consumption influenced the carotenoid content and enzymes associated with the antioxidant properties of HDL in subjects with T@D .


Eighty obese subjects with T@D were randomised to a @ - or @-portion/dayF & V diet for @-weeks .


Fasting serum was collected pre - and post-intervention .


HDL was subfractionated into HDL@ and HDL@ by rapid ultracentrifugation .


Carotenoids were measured in serum , HDL@ and HDL@ by high performance liquid chromatography .


The activity of paraoxonase-@ ( PON-@ ) was measured in serum , HDL@ and HDL@ by a spectrophotometric assay , while the activity of lecithin cholesterol acyltransferase ( LCAT ) was measured in serum , HDL@ and HDL@ by a fluorometric assay .


In the @ - vs. @-portion post-intervention comparisons , carotenoids increased in serum , HDL@ and particularly HDL@ , ( - carotene , p = @ ; - cryptoxanthin , p = @ ; lutein , p = @ ; lycopene , p = @ ) , as did the activities of PON-@ and LCAT in HDL@ ( p = @ and @ , respectively ) .


To our knowledge , this is the first study in subjects with T@D to demonstrate that increased F&V intake augmented the carotenoid content and influenced enzymes associated with the antioxidant properties of HDL .


We suggest that these changes would enhance the cardioprotective properties of this lipoprotein .


Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis .


The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms , risk factors for these events , and the effects of cinacalcet , using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events ( EVOLVE ) Trial .


EVOLVE was a randomized , double-blind , placebo-controlled clinical trial that randomized @ hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to @ months .


For this post hoc analysis , the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases .


During the trial , @ patients experienced an adjudicated cardiovascular event , including @ attributable to nonatherosclerotic disease .


Of @ deaths during the trial , @ ( @ % ) were due to cardiovascular disease .


Sudden death was the most frequent fatal cardiovascular event , accounting for @ % of overall mortality .


Combining fatal and nonfatal cardiovascular events , randomization to cinacalcet reduced the rates of sudden death and heart failure .


Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events ( adjusted relative hazard @ , @ % CI @ to @ ) , while the effect of cinacalcet on atherosclerotic events did not reach statistical significance .


Accepting the limitations of post hoc analysis , any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes .


The aims of this study were to compare radiofrequency tissue reduction ( RFTR ) and electrocautery ( EC ) techniques by assessing preoperatively and @ weeks postoperatively the visual analog scale ( VAS ) , inspiratory peak flowmetry ( IPF ) , and magnetic resonance imaging ( MRI ) volume measurement of the inferior turbinate and to see whether EC still stands as a valid treatment of inferior turbinate hypertrophy .


A total of @ patients were included in the study .


An equal number of patients were chosen randomly from @ groups .


Inferior turbinate volumes measured by MRI , IPF , the VAS , and the Sinonasal Outcome Test-@ were used to determine the efficacy of treatment and to compare the @ groups .


Postoperative IPF increase , VAS score decrease , and Sinonasal Outcome Test-@ score decrease were statistically more significant in the EC group , compared with the RFTR group .


Although statistically not significant , postoperative inferior turbinate MRI volume decrease was more evident in the EC group when compared with the RFTR group .


Both RFTR and EC techniques could be used as an effective treatment of choice for inferior turbinate hypertrophy , and EC technique is superior to RFTR technique to achieve high efficiency .


Immunization of healthy volunteers during receipt of chemoprophylaxis with Plasmodium falciparum sporozoites ( CPS-immunization ) induces sterile protection from malaria .


Antibody responses have long been known to contribute to naturally acquired immunity against malaria , but their association with sterile protection after whole sporozoite immunization is not well established .


We therefore studied the induction and kinetics of malaria parasite antigen-specific antibodies and memory B-cells ( MBCs ) during CPS-immunization and their correlation with protection from challenge infection .


We assessed humoral reactivity to @ antigens representing different stages of the life cycle of P. falciparum by performing standardized MBC enzyme-linked immunospot and enzyme-linked immunosorbent assays on peripheral blood mononuclear cells and plasma samples from @ Dutch volunteers enrolled in @ randomized controlled clinical trials .


MBCs and antibodies recognizing pre-erythrocytic and cross-stage antigens were gradually acquired during CPS-immunization .


The magnitude of these humoral responses did not correlate with protection but directly reflected parasite exposure in CPS-immunization and challenge .


Humoral responses to the malarial antigens circumsporozoite protein , liver-stage antigen-@ , apical membrane antigen-@ , and merozoite surface protein-@ do not to predict protection from challenge infection but can be used as sensitive marker of recent parasite exposure .


To examine effects of music therapy and progressive muscle relaxation training on depression , anxiety and length of hospital stay in Chinese female breast cancer patients after radical mastectomy .


A total of @ patients were randomly allocated to the intervention group ( n = @ ) receiving music therapy and progressive muscle relaxation training plus routine nursing care and the control group ( n = @ ) receiving routine nursing care .


Music therapy and progressive muscle relaxation training were performed twice a day within @ h after radical mastectomy , once in the early morning ( @a.m.-@a .


m. ) and once in the evening ( @p.m.-@p .


m. ) , for @ min per session until discharged from the hospital .


A general linear model with univariate analysis showed that the intervention group patients had significant improvement in depression and anxiety in the effects of group ( F = @ , P < @ ; F = @ , P = @ ) , time ( F = @ , P < @ ; F = @ , P < @ ) and group * time interaction ( F = @ , P = @ ; F = @ , P = @ ) .


The intervention group patients had shorter length of hospital stay ( @ @ ) than that of the control group ( @ @ ) with statistical significance ( F = @ , P < @ ) .


Music therapy and progressive muscle relaxation training can reduce depression , anxiety and length of hospital stay in female breast cancer patients after radical mastectomy .


To investigate the effectiveness of Shoushen granule , Chinese herbal preparation , on carotid artery elasticity in patients with carotid atherosclerosis .


The total of @ carotid atherosclerosis patients were randomly divided into the intervention group ( @ cases , treated with Shoushen granule ) and the control group ( @ cases , treated with pravastatin ) .


Brachial-ankle pulse wave velocity baPWV ) and Ankle-Brachial Pressure Index ( ABI ) were measured by automated arteriosclerosis detector .


The changes of common carotid artery intima-media thickness ( IMT ) and parameters of the carotid artery elasticity in patients , including stiffness parameter ( ) , pressure-strain elastic modulus ( Ep ) , arterial compliance ( Ac ) , augmentation index ( AI ) , and pulse wave velocity ( PWV ) were detected by Echo-Tracking ( ET ) technique before and after @ week treatment .


In the meantime , levels of blood lipid , and liver and renal function were measured respectively .


After @ weeks , baPWV , MT and parameters of the carotid artery elasticity ( , Ep , AI and PWV ) were markedly decreased in intervention group compared with those of before treatment ( P < @ ) , but the level of Ac was increased significantly ( P < @ ) .


And there were no significant differences compared with control group on the same period ( P > @ ) .


In this pilot study , it was demonstrated ET technology and automated arteriosclerosis detector could be used to evaluate carotid artery elasticity effectively , and the action of Shoushen granule on carotid atherosclerosis might be related to the regulation of carotid artery elasticity .


To determine the effect of nonlinear frequency compression ( NLFC ) on children 's development of speech and language at three years of age .


A randomized controlled trial was conducted as part of the population-based longitudinal study on outcomes of children with hearing impairment ( LOCHI ) .


Participants were randomly assigned to fitting with NLFC ( Phonak Naida V SP or UP ) or with conventional processing in hearing aids , prescribed by using either the NAL or the DSL formula .


Standardized tests of speech production , receptive and expressive language were administered , and parent ratings were collected .


All assessments were double-blinded .


Participants were @ of the @ children in the LOCHI cohort .


Compared to children using conventional processing , receptive and expressive language was higher but receptive vocabulary and consonant articulation scores were lower for children who use NLFC .


There was increased substitution of affricates by fricatives for children using NLFC , compared to children using conventional amplification .


After allowing for the effect of multiple demographic variables , the difference in global language scores between groups was not significant ( effect : @ -LSB- @ % confidence interval : - @ , @ -RSB- ) .


There is insufficient evidence to indicate a difference in language ability between children using NLFC and those using conventional amplification .


A prospective , randomized , controlled , double-blind clinical trial to assess the effect of tramadol and ketamine , @ mg , added to ropivacaine in brachial plexus anesthesia .


Thirty-six ASA physical statuses I and II patients , between @ and @ years of age , scheduled for forearm and hand surgery under axillary brachial plexus block , were allocated to @ groups .


Group R received @ % ropivacaine in @ mL , group RT received @ % ropivacaine in @ mL with @ mg tramadol , and group RK received @ % ropivacaine in @ mL with @ mg ketamine for axillary brachial plexus block .


The onset times and the duration of sensory and motor blocks , duration of analgesia , hemodynamic parameters , and adverse events ( nausea , vomiting , and feeling uncomfortable ) were recorded .


The onset time of sensorial block was the fastest in ropivacaine + tramadol group .


Duration of sensorial and motor block was the shortest in the ropivacaine + tramadol group .


Duration of analgesia was significantly longer in ropivacaine + tramadol group .


We conclude that when added to brachial plexus analgesia at a dose of @ mg , tramadol extends the onset and duration time of the block and improves the quality of postoperative analgesia without any side effects .


The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events ( SAEs ) in patients with inflammatory arthritides .


An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate ( MTX ) - naive rheumatoid arthritis patients , with ultrasounds performed at weeks @ , @ , and @ to measure common carotid artery intima-media thickness , distensibility coefficient , interadventitial diameter , and plaque count .


Cardiovascular SAEs reported over @ years of follow-up were assessed in @ golimumab phase @ clinical trials of patients with rheumatoid arthritis ( GO-BEFORE , GO-FORWARD , and GO-AFTER ) , psoriatic arthritis ( GO-REVEAL ) , and ankylosing spondylitis ( GO-RAISE ) .


In GO-BEFORE and GO-FORWARD , patients received placebo + MTX , golimumab @ mg + MTX , or golimumab @ mg + / - MTX at baseline and every @ weeks ; in the other @ trials , patients received placebo or golimumab @ or @ mg .


The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time , and there was large variability in the measurements .


Increases in interadventitial diameter were observed in the golimumab @ mg + placebo group , but not in the golimumab + MTX groups .


There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups .


Very few patients overall experienced a cardiovascular SAE , and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups .


The results of the carotid ultrasound substudy were inconclusive , and no increase or decrease in cardiovascular SAEs was observed following @ years of treatment with golimumab with or without MTX .


Although botulinum toxin type A ( BoNT-A ) has been used effectively and safely to reduce facial dynamic wrinkles , few studies assessed patients ' quality of life and satisfaction after treatment .


To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A ( ABO ) .


Ninety subjects were randomized into @ different groups , receiving @-@ U , @-@ U and @-@ U , respectively .


WHOQOL - BREF and Satisfaction and Self-assessment Questionnaire ( SSQ ) were completed by subjects up to @ months after treatment .


Most of the subjects were women ( @ % ) .


For the physical domain in WHOQOL , a difference was observed between baseline and visit @ ( p = @ ) .


There was no difference between groups for mean grades regarding amount of wrinkles , beauty , harmony and symmetry .


However , there was a significant difference in the mean grades between visits .


Patients ' opinions also showed an improvement in their self-image up to four months after treatment , according to the self-grading .


The results presented in this study show improvements in patients ' quality of life during the peak of action of BoNT-A treatment , regarding the physical aspect .


In addition , patients reported good satisfaction after a full-face approach .


This study extends previous research on masculinity and negative drinking consequences among young men by considering mediating effects of heavy episodic drinking ( HED ) and alcohol expectancies .


We hypothesized that masculinity would have a direct relationship with negative consequences from drinking as well as indirect relationships mediated by HED and alcohol expectancies of courage , risk , and aggression .


A random sample of @,@ college and university men ages @-@ years completed an online survey , including conformity to masculine norms , alcohol-related expectancies , HED , and negative drinking consequences .


Regression analyses and structural equation modeling were used .


Six of seven dimensions of masculinity and the alcohol expectancy scales were significantly associated with both HED and negative consequences .


In multivariate regression models predicting HED and negative consequences , the playboy and violence dimensions of masculinity and the risk/aggression alcohol expectancy remained significant .


HED and the risk-taking dimension of masculinity were also significant in the model predicting negative consequences .


The structural equation model indicated that masculinity was directly associated with HED and negative consequences but also influenced negative consequences indirectly through HED and alcohol expectancies .


The findings suggest that , among young adult male college and university students , masculinity is an important factor related to both HED and drinking consequences , with the latter effect partly mediated by HED and alcohol expectancies .


Addressing male norms about masculinity may help to reduce HED and negative consequences from drinking .


To evaluate the acceptance of midazolam spray through buccal route as compared to intranasal route and compare the efficacy of the drug through both the routes .


@ patients aged @-@ years with Grade I or II Frankl 's Behaviour Rating Scale were selected who required similar treatment under local anesthesia on two teeth .


Midazolam spray was administered randomly through buccal or intranasal routes for the two appointments .


Scoring was done for the acceptance of drug and Houpt 's score was recorded for the behaviour of patients during the treatment .


Acceptance of drug through buccal route was significantly better than the intranasal route ( p < @ ) but no statistically significant difference was found in the behaviour scores for the two routes of administration ( p > @ ) .


Midazolam spray can be effectively used through the buccal mucosa in children who give poor compliance with the intranasal administration .


To compare the efficacy and adverse effects of ergometrine and oxytocin given intramuscularly for the prevention of postpartum hemorrhage during the third stage of labor .


The study included women with a singleton pregnancy of at least @ weeks ' gestation who had a vaginal delivery .


High-risk pregnancies were excluded .


Oxytocin ( @ IU ) or ergometrine ( @ mg ) were administered intramuscularly in a blinded pattern immediately after delivery of the infant .


An intention-to-treat analysis was performed .


Postpartum blood loss ( @ @ mL versus @ @ mL , P = @ ) and packed cell volume ( @ @ % versus @ @ % ; Z = @ ; P = @ ) were considerably reduced among parturients who received intramuscular ergometrine .


The rates of therapeutic oxytocics use , blood transfusion , placental retention , and manual removal of the placenta were significantly higher in the oxytocin group .


No significant differences between the groups were observed in terms of adverse effects , with the exception of diastolic hypertension , which was more common in the ergometrine group ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Intramuscular ergometrine is superior to intramuscular oxytocin in averting postpartum hemorrhage during the third stage of labor .


There are no significant risks of adverse effects except for diastolic hypertension .


We aim to report the `` deep tiny flow voids '' ( DTFV ) , a unique HR-MRI finding suggestive of deep collateral vessels along middle cerebral artery ( MCA ) occlusions .


We retrospectively reviewed the HR-MRI data of @ patients with unilateral MCA occlusion ( @ symptomatic and @ asymptomatic ) and @ control subjects with normal MCA on magnetic resonance angiography .


The presence or absence of DTFV , defined as three or more flow voids along the occluded MCA on at least two consecutive T@-weighted image slices , was observed .


The relationships among DTFV , clinical presentations , and infarct sizes were analyzed .


DTFV were identified in @/@ ( @ % ) patients with asymptomatic MCA occlusions , much more frequently than in the patients with symptomatic occlusions ( @/@ , @ % ) ( P < @ ) .


There were @ patients with a large territorial infarction ( @/@ MCA distribution ) , none of whom had DTFV on HR-MRI .


DTFV was not observed in any control subject .


DTFV are pathological conditions and associated with relatively good imaging outcomes and asymptomatic MCA occlusions .


The function and clinical implications of DTFV warrant further investigations .


Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis ( DFO ) .


This study sought to compare the effectiveness of @ versus @ weeks of antibiotic therapy in patients with DFO treated nonsurgically ( i.e. , antibiotics alone ) .


This was a prospective randomized trial comparing @ - versus @-week duration of antibiotic treatment .


Remission of osteomyelitis during the monitoring period was defined as complete and persistent ( > @ weeks ) healing of the wound ( if present initially ) , absence of recurrent infection at the initial site or that of adjacent rays , and no need for surgical bone resection or amputation at the end of a follow-up period of at least @ months after completion of antibiotic treatment .


Forty patients followed at five French general hospitals were randomized between January @ and January @ , with @ treated for @ weeks and @ treated for @ weeks with antibiotics .


The two groups were comparable for all variables recorded at inclusion in the study .


Remission was obtained in @ ( @ % ) patients , with no significant differences between patients treated for @ versus @ weeks ( @/@ vs. @/@ , respectively ; P = @ ) .


We did not identify any significant parameters associated with patient outcome .


Fewer patients treated for @ weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for @ weeks ( respectively , @ vs. @ % ; P = @ ) .


The present multicenter prospective randomized study provides data suggesting that @-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered .


OnabotulinumtoxinA was effective and well tolerated for prophylaxis of headache in patients with chronic migraine ( CM ) in two randomized , double-blind , placebo-controlled , phase @ trials .


To further assess the safety and tolerability of onabotulinumtoxinA in CM prophylaxis in adults , the pooled safety data from four double-blind , placebo-controlled trials were analyzed .


The pooled analysis included two phase @ and two phase @ double-blind , placebo-controlled trials .


The safety population was @ patients , @ of whom received @ dose of onabotulinumtoxinA .


The studies shared similar dosing intervals ( approximately @weeks ) with doses between @ and @U .


Safety assessments included adverse events ( AEs ) , physical examination and clinical laboratory tests .


OnabotulinumtoxinA was safe and well tolerated , with a low discontinuation rate ( @ % ) due to AEs .


The majority of patients in this pooled analysis received doses between @ and @U , with an average of @U per treatment cycle .


Of the @ patients who received any onabotulinumtoxinA injections , @ patients ( @ % ) reported at least one AE .


Neck pain ( @ % ) was the most common onabotulinumtoxinA-associated AE , followed by muscle weakness ( @ % ) , musculoskeletal stiffness ( @ % ) and eyelid ptosis ( @ % ) .


Serious AEs were infrequent , occurring in @ % of patients who received any onabotulinumtoxinA treatment and @ % of patients receiving placebo .


AEs were consistent with the known tolerability profile of onabotulinumtoxinA .


Multiple treatments with onabotulinumtoxinA at doses of @-@U administered every @weeks , and up to five treatment cycles , were well tolerated for the prophylaxis of headache in adults with CM .


To assess the effects of intravitreal ranibizumab on diabetic retinopathy ( DR ) severity when administered for up to @ years , evaluate the effect of delayed initiation of ranibizumab therapy on DR severity , and identify baseline patient characteristics associated with the development of proliferative DR ( PDR ) .


Exploratory analyses of phase III , randomized , double-masked , sham-controlled multicenter clinical trials .


Adults with diabetic macular edema ( DME ) ( N = @ ) , baseline best-corrected visual acuity @/@ to @/@ Snellen equivalent , and central foveal thickness @ m.


Patients were randomized to monthly @ or @ mg ranibizumab or sham injections .


Sham participants could switch to @ mg ranibizumab during the third year ( sham/@ @ mg crossover ) .


Baseline risk factors were evaluated to explore potential associations with development of PDR .


Time to first development of PDR was analyzed by Kaplan-Meier methods to calculate cumulative probabilities by group .


Study eye change on the Early Treatment Diabetic Retinopathy Study severity scale and a composite clinical outcome evaluating progression to PDR based on photographic changes plus clinically important events defining PDR .


At month @ , a greater proportion of ranibizumab-treated eyes had @ - or @-step DR improvement compared with sham/@ @ mg crossover .


A @-step improvement was achieved at @ months by @ % , @ % , and @ % of sham/@ @ mg , @ mg , and @ mg ranibizumab-treated eyes , respectively ( P < @ ) .


Through @ months , @ % of eyes in the sham/@ @ mg group developed PDR , as measured by composite outcome , compared with @ % and @ % of eyes treated with @ or @ mg ranibizumab , respectively .


The presence of macular capillary nonperfusion at baseline seems to be associated with progression to PDR in ranibizumab-treated eyes but did not meaningfully influence visual acuity improvement in eyes with DME after ranibizumab therapy .


Ranibizumab , as administered to patients with DME for @ to @ months in these studies , can both improve DR severity and prevent worsening .


Prolonged delays in initiation of ranibizumab therapy may limit this therapeutic effect .


Although uncommon , the development of PDR still occurs in a small percentage of eyes undergoing anti-vascular endothelial growth factor therapy and may be related to the presence of macular nonperfusion .


This study sought to prospectively evaluate changes in marginal bone levels and soft tissue dimensions around platform-switched , Morse taper-connection implants placed with the implant-abutment interface ( IAI ) at different positions in relation to the alveolar crest .


Thirty patients in need of single-tooth rehabilitations were randomly assigned to three groups based on the position of the IAI in relation to the alveolar crest at the time of implant placement .


Implants in groups @ , @ , and @ ( n = @ in each group ) were placed at the bone level or @ mm and @ mm below the buccal aspect of the alveolar crest , respectively .


Four months later , the implants were restored with crowns .


Clinical parameters were recorded at @ and @ months , and marginal bone levels were assessed radiographically at placement , @ months , and @ months .


Mean marginal bone loss below the implant platform in group @ implants was @ @ mm at @ months and @ @ mm at @ months .


All implants in groups @ and @ exhibited no marginal bone loss below the implant platform , since the first bone-to-implant contact was located at or above the implant margin .


At @ months , implants in groups @ and @ exhibited greater mean bone loss above the implant platform compared to implants in group @ , but the differences were not statistically significant ( group @ , @ @ mm ; group @ , @ @ mm ; group @ , @ @ mm ) .


Implants in groups @ and @ exhibited a statistically significantly higher percentage of implant surfaces with bone on the implant platform compared to group @ implants ( @ % versus @ % ) .


In the present study , differences in peri-implant bone responses existed for implants placed with the IAI at different locations in relation to the alveolar crest .


In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) , patients with non-left bundle branch block ( LBBB ; including right bundle branch block , intraventricular conduction delay ) did not have clinical benefit from cardiac resynchronization therapy with defibrillator ( CRT-D ) .


We hypothesized that baseline PR interval modulates clinical response to CRT-D therapy in patients with non-LBBB .


Non-LBBB patients ( n = @ ; @ % ) were divided into @ groups based on their baseline PR interval as normal ( including minimally prolonged ) PR ( PR < @ ms ) and prolonged PR ( PR @ ms ) .


The primary end point was heart failure or death .


Separate secondary end points included heart failure events and all-cause mortality .


Cox proportional hazards regression models were used to compare risk of end point events by CRT-D to implantable cardioverter defibrillator therapy in the PR subgroups .


There were @ patients ( @ % ) with a prolonged PR and @ patients ( @ % ) with a normal PR interval .


In non-LBBB patients with a prolonged PR interval , CRT-D treatment was associated with a @ % reduction in the risk of heart failure/death ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) and @ % decrease in the risk of all-cause mortality ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) compared with implantable cardioverter defibrillator therapy .


In non-LBBB patients with normal PR , CRT-D therapy was associated with a trend toward an increased risk of heart failure/death ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ; interaction P < @ ) and a more than @-fold higher mortality ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ; interaction P < @ ) compared with implantable cardioverter defibrillator therapy .


The data support the use of CRT-D in MADIT-CRT non-LBBB patients with a prolonged PR interval .


In non-LBBB patients with a normal PR interval , implantation of a CRT-D may be deleterious .


Diabetic patients treated with metformin have a lower risk of developing BC or a better BC prognosis .


Metformin might reduce cancer growth through direct antiproliferative effects or through indirect mechanisms , particularly the reduction of insulin .


In a randomized study on nondiabetic BC patients in natural menopause with hightestosterone levels , we observed a significant decrease in insulin and in testosterone levels with metformin @mg/d compared with @ mg/d .


We present the results of a new analysis of our study on the effect of metformin on the bioavailability of sex hormones .


One hundred twenty-four eligible women were initiallyinvited to take metformin @ mg/d for @ months .


The @ women who completed the first @ months continued the study using @ mg/d for @ month .


The women were then randomized into @ groups , and , for the subsequent @months , @ group increased the dose to @ mg/d , and the other group continued with @ mg/d .


Ninety-six women completed the study , @ receiving metformin @ mg/day , and @ receiving @ mg/day .


The women receiving @ mg/d showed a greater and significant reduction of free testosterone ( -@ % ) and estradiol ( -@ % ) , a borderline significant reduction of estrone and insulin-like growth factor-@ , and a nonsignificant reduction of androstenedione .


They also showed a nonsignificant increase of dehydroepiandrosterone sulfate .


Metformin does not interfere with the production of dehydroepiandrosterone sulfate .


Besides , it decreases estradiol levels , basically through the reduction of testosterone .


These hormonal changes might have clinical relevance .


Upper airway obstruction ( UAO ) is a major problem in unconscious subjects , making full face mask ventilation difficult .


The mechanism of UAO in unconscious subjects shares many similarities with that of obstructive sleep apnea ( OSA ) , especially the hypotonic upper airway seen during rapid eye movement sleep .


Continuous positive airway pressure ( CPAP ) via nasal mask is more effective at maintaining airway patency than a full face mask in patients with OSA .


We hypothesized that CPAP via nasal mask and ventilation ( nCPAP ) would be more effective than full face mask CPAP and ventilation ( FmCPAP ) for unconscious subjects , and we tested our hypothesis during induction of general anesthesia for elective surgery .


In total , @ adult subjects requiring general anesthesia were randomly assigned to one of four groups : nCPAP P@ , nCPAP P@ , FmCPAP P@ , and FmCPAP P@ , where P@ and P@ represent positive end-expiratory pressure ( PEEP ) @ and @ cm H@O applied prior to induction .


After apnea , ventilation was initiated with pressure control ventilation at a peak inspiratory pressure over PEEP ( PIP/PEEP ) of @/@ , then @/@ , and finally @/@ cm H@O , each applied for @ min .


At each pressure setting , expired tidal volume ( Vte ) was calculated by using a plethysmograph device .


The rate of effective tidal volume ( Vte > estimated anatomical dead space ) was higher ( @ % vs. @ % ; P < @ ) and the median Vte was larger ( @ vs. @ mL/kg ; P < @ ) with nCPAP than with FmCPAP .


Application of CPAP prior to induction of general anesthesia did not affect Vte in either approach ( nCPAP pre - vs. post - ; @ vs. @ mL/kg , P = @ ) ( FmCPAP pre - vs. post - ; @ vs. @ mL/kg , P = @ ) .


nCPAP produced more effective tidal volume than FmCPAP in unconscious subjects .


Viral upper respiratory tract infections occur frequently among conscripts .


Probiotics have reduced viral infections in children attending day care .


Limited data are available on the effects of probiotics on the nasopharyngeal presence of respiratory viruses .


To assess , whether probiotics could decrease nasopharyngeal occurrence of respiratory viruses in Finnish conscripts .


In a randomized , double-blind , placebo-controlled @ - and @-day intervention study , @ nasopharyngeal swab samples were collected from @ symptomatic conscripts receiving daily chewable probiotic tablet containing Lactobacillus rhamnosus GG and Bifidobacterium animalis ssp .


lactis BB-@ ( @ % ) or control tablet ( @ % ) on visits to a garrison 's health care center due to symptoms of infection .


The presence of respiratory viruses was tested by PCR-methods , and viral findings were compared between the intervention groups .


@ ( @ % ) nasopharyngeal samples were positive for at least one respiratory virus .


Picornaviruses were the most common viruses and were detected in @ ( @ % ) of samples .


Of these , @ ( @ % ) were rhinovirus-positive and @ ( @ % ) were enterovirus-positive .


The control group had @ ( @ % ) and the probiotic group @ ( @ % ) picornavirus infections ( p = @ ) .


Monthly distribution of picornaviruses showed that there were less picornavirus findings after @ months in the probiotic group than in the control group ( p = @ ) .


However , probiotics did not reduce picornavirus occurrence in other months .


Overall , probiotics did not reduce viral occurrence in symptomatic conscripts .


However , probiotics decreased the presence of picornaviruses after @ months , which may imply that probiotics play a role against viruses causing common cold .


Further investigations are necessary to clarify the mechanisms involved in order to target specific probiotics on specific respiratory viruses .


Many hypertensive subjects travel to high altitudes , but little is known on ambulatory blood pressure ( ABP ) changes and antihypertensive drugs ' efficacy under acute and prolonged exposure to hypobaric hypoxia .


In particular , the efficacy of angiotensin receptor blockers in this condition is unknown .


This may be clinically relevant considering that renin-angiotensin system activity changes at altitude .


The HIGHCARE-HIMALAYA study assessed changes in @ h ABP under acute and prolonged exposure to increasing altitude and blood pressure-lowering efficacy and safety of an angiotensin receptor blockade in this setting .


Forty-seven healthy , normotensive lowlanders were randomized to telmisartan @ mg or placebo in a double-blind , parallel group trial .


Conventional and Ambulatory BPs were measured at baseline and on treatment : after @ weeks at sea level , and under acute exposure to @ and @ m altitude , the latter upon arrival and after @ days ( Mt. Everest base camp ) .


Blood samples were collected for plasma catecholamines , renin , angiotensin , and aldosterone .


In both groups , exposure to increasing altitude was associated with : ( i ) significant progressive increases in conventional and @ h blood pressure , persisting throughout the exposure to @ m ; ( ii ) increased plasma noradrenaline and suppressed renin-angiotensin-aldosterone system .


Telmisartan lowered @ h ABP at the sea level and at @ m ( between-group difference @ mmHg , @ % CI : @-@ @ mmHg ) , but not at @ m.


Ambulatory blood pressure increases progressively with increasing altitude , remaining elevated after @ weeks .


An angiotensin receptor blockade maintains blood pressure-lowering efficacy at @ m but not at @ m.


To determine the impact of recombinant luteinizing hormone ( rLH ) combined with vaginal progesterone ( P ) for luteal supplementation on in vitro fertilization ( IVF ) pregnancy outcomes in high-responder patients undergoing long gonadotropin-releasing hormone ( GnRH ) agonist cycles .


A total of @ patients undergoing IVF cycles with the serum estradiol levels of > or = @,@ pg/mL on the day of human chorionic gonadotropin administration were included in this prospective randomized study .


Patients were divided into @ treatment groups : the control group ( n = @ ) used luteal vaginal P , and the study group ( n = @ ) received a combination of vaginal P and @ IU rLH , @ doses every @ days , starting on the day of embryo transfer .


The main outcome measure was the clinical pregnancy rate ( PR ) .


The study group had @ pregnancies ( @ % ) , while the control group had @ ( @ % ) .


There was no significant difference between the groups in clinical PRs ( p = @ ) .


No differences were found with respect to the implantation rate , miscarriage rate , and multiple PR .


Our data show that luteal supplementation with rLH combined to vaginal P was not found to improve pregnancy outcomes in high responder patients undergoing long GnRH agonist IVF treatments .


Based on the result of our previous study showing better overall survival ( OS ) at the lower dose ( @ g ) of immunomodulator Z-@ than higher dose ( @ g ) in patients with locally advanced cervical cancer who received radiotherapy , we conducted a placebo-controlled double-blind randomized trial .


Patients of stages IIB-IVA squamous cell carcinoma of the uterine cervix were randomly assigned to receive Z-@ at @ g ( Z ) or placebo ( P ) .


The study agent was given subcutaneously twice a week during the radiotherapy , followed by maintenance therapy by administering once every @ weeks until disease progression .


Primary end point was OS , and secondary end points were recurrence-free survival , and toxicity .


A total of @ patients were randomized .


Death events occurred extremely slower than expected , and Independent Data Monitoring Committee recommended to analyze the survival result prematurely .


The @-year OS rate was @ % -LSB- @ % confidence interval ( CI ) @ % to @ % -RSB- for Arm Z and @ % ( @ % CI @ % to @ % ) for Arm P ( P = @ ) ; hazard ratio was @ ( @ % CI @-@ @ ) .


Survival benefit in Arm Z was observed regardless of chemoradiation or radiation alone .


There was no trend in recurrence-free survival between the two arms .


Side-effects were not different between two arms .


Z-@ showed a trend of improvement on OS in locally advanced cervical cancer , although the statistical power was less than anticipated because survival rates were unexpectedly higher than expected for both arms .


Validation of potential survival benefit of immune modulation should be made .


To compare the efficacy and safety of two different second-generation ablation devices , Novasure impedance control system and microwave endometrial ablation ( MEA ) , in cases of abnormal uterine bleeding ( AUB ) .


This is a randomized controlled trial that took place in a single Gynecological Department of a University Hospital .


Sixty-six women with dysfunctional uterine bleeding ( DUB ) , unresponsive to medical treatment , were included in the trial .


The ratio of women allocated to bipolar radio-frequency ablation or MEA was @:@ .


Follow-up assessments were carried out at three and @ months post-ablation .


The present main outcome measure was amenorrhea rates @-months post-treatment .


The rate of amenorrhea at @-months post-ablation was significantly higher in women treated by Novasure ( @/@ ; @ % ) as compared to those treated by MEA ( @/@ ; @ % ) ( rate difference : +@ % , @ % CI : +@ to +@ ) .


In women with DUB , endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at @-months post-treatment as compared to the MEA method .


To determine the effects of different intra-abdominal pressure values on visceral pain following gynecologic laparoscopic surgery in the Trendelenburg position .


This randomized , controlled prospective trial was conducted at a tertiary education hospital and included @ patients who underwent gynecologic laparoscopy with different abdominal insufflation pressures .


There were @ patients in the @ mmHg low pressure group ( LPG ) , @ in the @ mmHg standard pressure group ( SPG ) , and @ in the @ mmHg high pressure group ( HPG ) .


We assessed mean age , body mass index ( BMI ) , duration of surgery , analgesic consumption , length of hospital stay , amount of CO@ expended and volume of hemorrhage .


Visceral pain and referred visceral pain were assessed @ , @ , and @ h postoperatively using a visual analog scale ( VAS ) .


There was no significant difference in age , BMI , analgesic consumption or length of hospital stay among groups .


The mean operative time and total CO@ expended during surgery were higher in the LPG compared with the SPG and HPG .


The mean intensity of postoperative pain assessed by the VAS score at @ and @ h was less in the LPG than in the SPG and HPG and was reduced significantly at @ h. VAS scores at @ h in the LPG and SPG were lower than in the HPG .


Pain is reduced by low insufflation pressure compared with standard and high insufflation pressure following gynecologic laparoscopic surgery in the Trendelenburg position .


However , low insufflation pressure may result in longer operation times and increased hemorrhage .


The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated .


We studied the renal effects of two statins in patients with diabetes who had proteinuria .


PLANET I was a randomised , double-blind , parallel-group trial done in @ research centres in Argentina , Brazil , Bulgaria , Canada , Denmark , France , Hungary , Italy , Mexico , Romania , and the USA .


We enrolled patients with type @ or type @ diabetes aged @ years or older with proteinuria ( urine protein : creatinine ratio -LSB- UPCR -RSB- @-@ mg/g ) and taking stable angiotensin-converting enzyme inhibitors , angiotensin receptor blockers , or both .


We randomly assigned participants to atorvastatin @ mg , rosuvastatin @ mg , or rosuvastatin @ mg for @ weeks .


The primary endpoint was change from baseline to week @ of mean UPCR in each treatment group .


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


We enrolled @ patients : @ were assigned to rosuvastatin @ mg , @ to rosuvastatin @ mg , and @ to atorvastatin @ mg ; of these , @ were included in the intention-to-treat population .


UPCR baseline : week @ ratio was @ ( @ % CI @-@ ; p = @ ) with atorvastatin @ mg , @ ( @-@ ; p = @ ) with rosuvastatin @ mg , and @ ( @-@ ; p = @ ) with rosuvastatin @ mg .


In a post-hoc analysis to compare statins , we combined data from PLANET I with those from PLANET II ( a similar randomised parallel study of @ patients with proteinuria but without diabetes ; registered with ClinicalTrials.gov , NCT@ ) .


In this analysis , atorvastatin @ mg lowered UPCR significantly more than did rosuvastatin @ mg ( -@ % , @ % CI -@ to -@ ; p = @ ) and rosuvastatin @ mg ( -@ % , -@ to -@ ; p = @ ) .


Adverse events occurred in @ ( @ % ) of @ patients in the rosuvastatin @ mg group versus @ ( @ % ) of @ patients in the rosuvastatin @ mg group versus @ ( @ % ) of @ patients in the atorvastatin @ mg group ; renal events occurred in nine ( @ % ) versus @ ( @ % ) versus five ( @ % ) .


Despite high-dose rosuvastatin lowering plasma lipid concentrations to a greater extent than did high-dose atorvastatin , atorvastatin seems to have more renoprotective effects for the studied chronic kidney disease population .


To investigate the efficacy and safety of combining vandetanib , an orally available multi-targeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor-@ ( VEGFR-@ ) and epidermal growth factor receptor ( EGFR ) , with bicalutamide in patients with metastatic castration-resistant prostate cancer ( mCRPC ) .


This was an open-label , randomized phase II multi-center study .


Eligible patients had rising PSA on androgen deprivation therapy , minimal symptoms and were chemotherapy-nave .


Protocol therapy was either vandetanib @ mg oral daily plus bicalutamide @ mg oral daily ( Arm A ) or bicalutamide @ mg oral daily alone ( Arm B ) with cross-over to vandetanib monotherapy at progression .


The primary endpoint was PSA response ( @ % decline from baseline ) .


Thirty-nine patients were recruited , @ in Arm A and @ in Arm B. PSA response was comparable in Arm A and Arm B ( @ vs. @ % ) .


Time to PSA progression was @ months ( @ % confidence interval ( CI ) : @ , not reached ( NR ) ) for Arm A and @ months ( @ % CI : @ , NR ) for Arm B. Treatment discontinuation due to adverse events was more common in Arm A compared to Arm B ( @ vs. @ % ; p = @ ) .


Treatment with vandetanib was associated with a reduction in soluble VEGFR-@ levels after two cycles but an increase in plasma VEGF levels .


The combination of vandetanib and bicalutamide was associated with considerable toxicity and did not have superior efficacy over bicalutamide alone .


Further evaluation of this combination is not warranted in mCRPC .


FcR polymorphisms have been reported to enhance the immune-mediated effects of cetuximab in metastatic colorectal cancer .


There are no data on the relationship between these polymorphisms and cetuximab in the early-stage setting .


We performed a pharmacogenomic analysis of EXPERT-C , a randomized phase II trial of neoadjuvant CAPOX followed by chemoradiotherapy , surgery , and adjuvant CAPOXcetuximab in high-risk , locally advanced rectal cancer .


FcRIIa-H@R and FcRIIIa-V@F polymorphisms were analyzed on DNA from peripheral blood samples .


Kaplan-Meier method and Cox regression analysis were used to calculate survival estimates and compare treatment arms .


Genotyping was successfully performed in @ of @ ( @ % ) patients ( CAPOX = @ , CAPOX-C = @ ) .


No deviation from the Hardy-Weinberg equilibrium or association of these polymorphisms with tumor RAS status was observed .


FcRIIa-@R ( HR , @ ; P = @ ) and FcRIIIa-@F alleles ( HR , @ ; P = @ ) predicted improved progression-free survival ( PFS ) in patients treated with cetuximab .


In the CAPOX-C arm , carriers of both @R and @F alleles had a statistically significant improvement in PFS ( @ years : @ % ; HR , @ ; P = @ ) and overall survival ( OS ; @ years : @ % ; HR , @ ; P = @ ) when compared with patients homozygous for @H and/or @V ( @-year PFS : @ % ; @-year OS : @ % ) .


An interaction between cetuximab benefit and @R and @F alleles was found for PFS ( P = @ ) and remained significant after adjusting for prognostic variables ( P = @ ) .


This is the first study investigating FcRIIa and FcRIIIa polymorphisms in patients with early-stage colorectal cancer treated with cetuximab .


We showed an increased clinical benefit from cetuximab in the presence of @R and @F alleles .


Diabetic cardiomyopathy defined as either systolic or diastolic dysfunction in otherwise healthy diabetic persons is not clearly understood .


The prevalence and outcomes of this disease in a community-based population have not been defined .


Cross-sectional survey of @ randomly selected residents of Olmsted County , Minnesota , aged @ years or older between June @ and September @ .


All patients underwent Doppler echocardiographic assessment of systolic and diastolic function .


Diabetic cardiomyopathy was defined in a person with diabetes and any systolic or at least moderate diastolic dysfunction without a history of coronary disease , hypertension , significant valvular disease , or congenital heart disease .


The diagnosis of diabetic cardiomyopathy was made in @ people , corresponding to a community population prevalence rate of @ % .


Among diabetic patients , @ % met criteria for diabetic cardiomyopathy and @ % had diastolic dysfunction .


Diabetes was associated with a @-fold increase in risk of any left ventricular dysfunction , a @-fold increase in risk of diastolic dysfunction , and a @-fold increase in risk of systolic dysfunction .


Among patients with diabetic cardiomyopathy , the cumulative probability of death was @ % , development of heart failure was @ % , and development of death or heart failure was @ % at @ years .


Diabetic cardiomyopathy is relatively common in the community with a prevalence of @ % .


The morbidity and mortality of patients with diabetic cardiomyopathy is high .


Protein source , macronutrient composition and content of long chain-polyunsaturated fatty acids ( LC-PUFA ) of infant formulae may influence infant growth .


We aimed to assess the effect of a modified infant formula on growth .


In a randomized , double-blind trial , @ healthy term infants consumed isoenergetic study formulae ( intervention formula - IF , control formula - CF ) from the first month of life until the age of @ days .


IF ( @ g protein/@ kcal ) contained - lactalbumin ( ALAB ) and LC-PUFA , while CF ( @ g protein/@ kcal ) provided standard whey and no LC-PUFA .


Anthropometry and dietary intake were regularly assessed .


A venous blood sample was obtained on day @ .


Both formulae were well-accepted without significant differences in health related observations .


Weight gain was not statistically different between formula groups ( IF : @ @ vs. CF : @ @ g/day , mean SD , P = @ ) .


Length gain was higher in IF ( @ @ vs. @ @ cm/day , P = @ ) .


Energy intake from formula was higher in CF at @ and @ days ( IF : @ @ and @ @ vs. CF : @ @ and @ @ kcal/day , P < @ ) .


Protein intake in CF was significantly higher at each assessment .


Growth per energy intake was higher in IF compared to CF for weight ( @ @ vs. @ @ g/@ kcal , P = @ ) and length ( @ @ vs. @ @ mm/@ kcal , P = @ ) .


The modified infant formula with reduced protein content with added ALAB and LC-PUFA , meets infant requirements of protein for adequate growth .


The increased energetic efficiency of the new infant formula might result from improved protein composition by added ALAB .


Apparently minor differences in composition can markedly affect energetic efficiency for growth .


The study was registered at ClinicalTrials.gov ( NCT@ ) .


This study examines the effects of parental lisdexamfetamine ( LDX ) treatment on parent-child interactions .


Participants were @ parents ( @ % were male ) and their children aged @-@ years , both diagnosed with DSM-IV attention-deficit/hyperactivity disorder ( ADHD ) .


Optimal LDX dose ( @ , @ , or @ mg/day ) was determined for parents during a @-week open-label titration , followed by a within-subjects trial of the acute impact of LDX and placebo on observable parent-child interactions .


Two laboratory-based , parent-child interactions simulating typical family tasks ( e.g. , homework , joint play ) were conducted within @ weeks , once with the adult on a blinded optimal dose of LDX and once on placebo ( phase I ) .


Parents were then randomly assigned to continue blinded treatment with LDX or placebo for another month followed by a third interaction task ( phase II ) to assess the ongoing effects of LDX on parent-child interactions .


The primary outcome was the change in rate of parenting behaviors coded during the parent-child interaction tasks .


Secondary outcomes included observed rates of children 's inappropriate behaviors during the laboratory tasks and changes in parental ADHD symptom severity ( ADHD-Rating Scale ) .


Twenty parents ( @ % ) completed the trial .


In phase I , medication was associated with a significant reduction in negative talk by parents ( p = @ , d = -@ ) .


There was a Medication Task interaction ( p = @ ) with a reduction in children 's negative behaviors in the homework phase only ( p = @ , d = -@ ) .


In phase II , LDX was associated with significant increases in praise by parents ( d = @ ) and reductions in parental commands ( d = -@ ) and children 's inappropriate behaviors ( d = -@ ) ( all p-values < @ ) .


While not reaching statistical significance , LDX was also associated with large reductions in parental verbalizations ( d = -@ ) , moderate increases in parental responsiveness ( d = @ ) , and large reductions in the ratio of commands to verbalizations during the non-homework task ( d = -@ ) ( all p-values < @ ) .


Significant reductions in parental ADHD symptoms vs. placebo were observed ( p < @ ) .


Loss of appetite , dry mouth , headaches , and delayed sleep onset were the most common adverse events .


Improvements in parent-child interactions emerged over time with LDX treatment of parental ADHD .


Results suggest that pharmacological treatment of parental ADHD may improve outcomes in parents and their children .


The aim of this study was to investigate the effects of a restrictive vs. a liberal postoperative fluid therapy guided by intrathoracic blood volume index ( ITBVI ) on hemodynamic and pulmonary function in patients undergoing elective esophagectomy .


Perioperative fluid therapy may influence postoperative physiology and morbidity after esophageal surgery .


Definitions of adequate infusion amounts and evident rules for a fluid therapy are missing .


After esophagectomy , @ patients were randomized either to a restrictive group ( RG ) with low range of ITBVI ( @-@ ml/m@ ) or a liberal group ( LG ) with normal ITBVI ( @-@ ml/m@ ) .


Infusion regimen was modified twice a day according to transpulmonary thermodilution measurements until the @th postoperative day .


Primary endpoint was paO@/FIO@-ratio .


Secondary endpoints were pulmonary function , fluid balance and hemodynamic as well as morbidity .


Demographic and surgical details did not differ between both groups .


The calculated sample size was not reached .


There were no postoperative differences in paO@/FIO@-ratio , ITBVI , hemodynamic parameters , or morbidity either .


Cumulative fluid uptake was @ liter less in the RG on the @th postoperative day ( p = @ ) , and pulmonary function was better in these patients ( area under curve day @-@ for forced vital capacity ( FVC ) , forced expiratory volume in one second ( FEV@ ) , peak expiratory flow ( PEF ) each < @ ) .


ITBVI guided restrictive infusion therapy yields a lower fluid uptake , but may not result in a difference of clinical relevant parameters .


A fluid restriction after esophagectomy should always be combined with hemodynamic monitoring because additional infusions may be required .


Recurrent vascular events remain a major source of morbidity and mortality after stroke or transient ischemic attack ( TIA ) .


The IRIS Trial is evaluating an approach to secondary prevention based on the established association between insulin resistance and increased risk for ischemic vascular events .


Specifically , IRIS will test the effectiveness of pioglitazone , an insulin-sensitizing drug of the thiazolidinedione class , for reducing the risk for stroke and myocardial infarction ( MI ) among insulin resistant , nondiabetic patients with a recent ischemic stroke or TIA .


Eligible patients for IRIS must have had insulin resistance defined by a Homeostasis Model Assessment-Insulin Resistance > @ without meeting criteria for diabetes .


Within @ months of the index stroke or TIA , patients were randomly assigned to pioglitazone ( titrated from @ to @ mg/d ) or matching placebo and followed for up to @ years .


The primary outcome is time to stroke or MI .


Secondary outcomes include time to stroke alone , acute coronary syndrome , diabetes , cognitive decline , and all-cause mortality .


Enrollment of @,@ participants from @ sites in @ countries was completed in January @ .


Participant follow-up will continue until July @ .


The IRIS Trial will determine whether treatment with pioglitazone improves cardiovascular outcomes of nondiabetic , insulin-resistant patients with stroke or TIA .


Results are expected in early @ .


Developing Web-based physical activity ( PA ) interventions based on motivational interviewing ( MI ) could increase the availability and reach of MI techniques for PA promotion .


Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention , compared to an intervention that is purely text-based .


The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention , when compared to an intervention that is purely text-based .


A three-arm randomized controlled trial was conducted , containing the following research conditions : ( @ ) a Web-based PA intervention based on MI with an avatar , ( @ ) a content-identical intervention without an avatar , and ( @ ) a control condition that received no intervention .


Measurements included PA behavior and process variables , measured at baseline , directly following the intervention and @ month post intervention .


Both interventions significantly increased self-reported PA at @ month , compared to the control condition ( beta ( AVATARvsCONTROL ) = @ , P = @ ; beta ( TEXTvsCONTROL ) = @ , P = @ ) .


No distinctions were found regarding intervention effect on PA between both interventions .


Similarly , the results of the process evaluation did not indicate any significant differences between both interventions .


Due to the limited relational skills of the avatar in this study , it probably did not succeed in forming a stronger relationship with the user , over and above text alone .


The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact .


Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study , such as responding in gesture to the user 's state and input .


This multicentre international randomized trial compared the impact of gadoxetic acid-enhanced magnetic resonance imaging ( MRI ) , MRI with extracellular contrast medium ( ECCM-MRI ) and contrast-enhanced computed tomography ( CE-CT ) as a first-line imaging method in patients with suspected colorectal cancer liver metastases ( CRCLM ) .


Between October @ and September @ , patients with suspected CRCLM were randomized to one of the three imaging modalities .


The primary endpoint was the proportion of patients for whom further imaging after initial imaging was required for a confident diagnosis .


Secondary variables included confidence in the therapeutic decision , intraoperative deviations from the initial imaging-based surgical plan as a result of additional operative findings , and diagnostic efficacy of the imaging modalities versus intraoperative and pathological extent of the disease .


A total of @ patients were enrolled .


Efficacy was analysed in @ patients ( @ , @ and @ with gadoxetic acid-enhanced MRI , ECCM-MRI and CE-CT respectively as the initial imaging procedure ) .


Further imaging was required in @ of @ , @ ( @ per cent ) of @ and @ ( @ per cent ) of @ patients respectively ( P < @ ) .


Diagnostic confidence was high or very high in @ per cent of patients for gadoxetic acid-enhanced MRI , @ per cent for ECCM-MRI and @ per cent for CE-CT .


Surgical plans were changed during surgery in @ , @ and @ per cent of patients in the respective groups .


The diagnostic performance of gadoxetic acid-enhanced MRI was better than that of CE-CT and ECCM-MRI as the initial imaging modality .


No further imaging was needed in the gadoxetic acid-enhanced MRI group and comparison of diagnostic efficacy parameters demonstrated the diagnostic superiority of gadoxetic acid-enhanced MRI .


School-based comprehensive sex education programs can reduce early adolescents ' risky sexual behavior .


The purpose of this study was to assess the effectiveness of a @-year comprehensive sex education program in delaying vaginal sex for middle school students and whether the family component of the intervention contributes to its effectiveness .


This longitudinal evaluation followed a cohort of @th graders ( N = @ ) through the end of @th grade .


The design used random assignment of @ schools into treatment and comparison conditions .


The analysis included multiple-group logistic regression to assess differences in delay of sex between intervention and comparison groups .


In schools where the program was taught , @ % fewer boys and @ % fewer girls had had sex by the end of @th grade compared to boys and girls at comparison schools .


Completing family activities during the first year of the program predicted delayed sexual debut for boys .


Theory-based , developmentally appropriate , comprehensive sex education programs that include parent involvement can be effective in delaying vaginal sex for middle school students .


Parent involvement is particularly important for boys , as family activities may encourage parents to talk with their sons earlier and more frequently .


Acupuncture is commonly used to reduce pain during labour despite contradictory results .


The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation ( electro-acupuncture ) compared with standard care in reducing labour pain .


Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care , and that electro-acupuncture was most effective .


A longitudinal randomised controlled trial .


The recruitment of participants took place at the admission to the labour ward between November @ and October @ at two Swedish hospitals .


@ nulliparous women with normal pregnancies were randomised to : @minutes of manual acupuncture ( MA ) , electro-acupuncture ( EA ) , or standard care without acupuncture ( SC ) .


labour pain , assessed by Visual Analogue Scale ( VAS ) .


relaxation , use of obstetric pain relief during labour and post-partum assessments of labour pain .


The sample size calculation was based on the primary outcome and a difference of @mm on VAS was regarded as clinically relevant , this gave @ in each group , including a total of @ women .


Mean estimated pain scores on VAS ( SC : @ , MA : @ and EA : @ ) , adjusted for : treatment , age , education , and time from baseline , with no interactions did not differ between the groups ( SC vs MA : mean difference @ , @ % confidence interval -LSB- CI -RSB- -@ -@ and SC vs EA : mean difference @ -LSB- @ % CI -RSB- -@ -@ ) .


Fewer number of women in the EA group used epidural analgesia ( @ % ) than women in the MA group ( @ % ) and SC group ( @ % ) ( EA vs SC : odds ratio -LSB- OR -RSB- @ ; -LSB- @ % CI -RSB- @-@ @ ) .


Acupuncture does not reduce women 's experience of labour pain , neither with manual stimulation nor with combined manual and electrical stimulation .


However , fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated .


These findings were obtained in a context with free access to other forms of pain relief .


To compare-the adequacy of endometrium and the post-procedural pain between the manual vacuum aspiration ( MVA ) and metal curettage method .


The present research was a clinical experiment .


A randomized controlled trial study was done with older than @-year oldfemales with abnormal intrauterine bleeding who attended the out-patient gynecology department of Maharat Nakhon Ratchasima Hospital between December @ , @ and April @ , @ .


Patients were allocated with simple randomization technique into two groups , the experimental group was using MVA and the control group was using conventional metal uterine curettage .


Pain levels were assessed according to the visual analogue scale .


All tissue samples were examined by pathologists .


Statistics used were percentage and Chi-square .


Percentages of tissue adequacy for pathological examination of control and experiment groups were @ and @ , respectively .


There was no significant difference between the two methods ( p-value = @ ) .


The patients with severe pain in the experiment group were less than that of the control group .


The relative risk is @ ( @ % CI = @-@ @ ) .


MVA caused less pain than the metal curette method , while both provided the same rate of adequacy of endometrial tissue sampling for pathological diagnosis .


The MVA offered more humanized health care for gynecological patients who required such procedure .


Further researches focusing on the cost-effectiveness or medical complications could benefit a practice guideline and the health care system for this patient group .


Exposure to acute ` stressors ' ( e.g. infections , pain , trauma ) often results in altered sleep habits and reductions in routine activity .


In some individuals , these behavioural responses to acute stressors may contribute to the development of chronic somatic symptoms such as widespread pain , fatigue , memory difficulties and mood disturbances , much like those associated with ` functional somatic syndromes ' ( FSS ) such as fibromyalgia or chronic fatigue syndrome .


Eighty-seven healthy young adults who reported sleeping between @ and @ hours nightly and exercising regularly were randomised to one of four groups : exercise cessation , sleep restriction ( @ hours nightly ) , both , or neither .


Symptoms of pain , fatigue , cognitive dysfunction and negative mood were measured before and after the @-day restriction period .


Sleep restriction was a potent contributor to the development of somatic symptoms .


Exercise cessation was less influential leading only to fatigue .


There were no significant interactions between exercise cessation and sleep restriction , except that males were much more likely to develop somatic symptoms when deprived of both sleep and exercise than one or the other .


Women were generally much more likely to develop somatic symptoms than men .


This study supports previous research suggesting that both sleep and exercise are critical in ` preventing ' somatic symptoms among some individuals .


Furthermore , to our knowledge , this is the first time there is data to suggest that women are much more sensitive to decrements in routine sleep and exercise than are men .


Abused women , who suffer from chronic psychological stress , have been shown to have shorter telomeres than never abused women .


Telomere shortening is associated with increased risk of cell death , and it is believed that adopting health-promoting behaviors can help to increase the activity of telomerase , an enzyme that counters telomere shortening .


Qigong is an ancient Chinese mind-body integration , health-oriented practice designed to enhance the function of qi , an energy that sustains well-being .


Therefore , an assessor-blind , randomized , wait-list controlled trial was developed to evaluate the effect of a qigong intervention on telomerase activity ( primary objective ) and proinflammatory cytokines , perceived stress , perceived coping , and depressive symptoms ( secondary objectives ) in abused Chinese women .


A total of @ Chinese women , aged @ years , who have been abused by an intimate partner within the past three years will be recruited from a community setting in Hong Kong and randomized to receive either a qigong intervention or wait-list control condition as follows : the qigong intervention will comprise ( i ) a @-hour group qigong training session twice a week for @ weeks , ( ii ) a @-hour follow-up group qigong exercise session once a week for @ months , and ( iii ) a @-minute self-practice qigong exercise session once a day for @ months .


The wait-list control group will receive qigong training after the intervention group completes the program .


Upon completion of the qigong intervention program , it is expected that abused Chinese women in the intervention group will have higher levels of telomerase activity and perceived coping and lower levels of proinflammatory cytokines , perceived stress , and depressive symptoms than will abused Chinese women in the wait-list control group .


This study will provide information about the effect of qigong exercise on telomerase activity and chronic psychological stress in abused Chinese women .


The findings will inform the design of interventions to relieve the effects of IPV-related psychological stress on health .


Also , the concept that health-promoting behaviors could slow down cellular aging might even motivate abused women to change their lifestyles .


The present study was to assess the reduction of right ventricular pacing ( RVP ) by pacemaker algorithms of Managed Ventricular Pacing ( MVP ) and Search AV + ( SAV + ) interval over a period of @ months .


A total of @ patients indicated for a dual-chamber pacemaker ( DC-PM ) were enrolled in the prospective , randomized COMPARE study at @ centres in China between June @ and April @ .


Patients implanted with DC-PMs were randomized in a @ : @ ratio to the MVP group or the SAV + group .


The percentage of VP ( % VP ) was obtained from the device diagnostic data at @ - , @ - , and @-month follow-ups and was expressed as the median % VP over all beats in patients with sinus node dysfunction ( SND ) and atrioventricular block ( AVB ) excluding persistent third-degree AVB .


Of @ enrolled patients , @ had SND and @ had AVB .


The % VP in the MVP group was significantly lower than that in the SAV + group at @ - , @ - , and @-month follow-ups , respectively .


At @-month follow-up , the median % VP in SND patients was @ % in the MVP group and @ % in the SAV + group ( P < @ ) and the median % VP in AVB patients was @ % in the MVP group and @ % in the SAV + group ( P < @ ) .


There was no statistical difference in % VP from @ - to @-month follow-up .


A trend in the correlation between % VP and AT/AF burden was observed .


Over @-month follow-up , the % VP was lower for MVP than SAV + in patients with either SND or AVB .


The sustainable % VP reduction has potential implications in reducing the development of heart failure and/or atrial arrhythmia morbidity .


Medical history is an important contributor to diagnosis and patient management .


In mass-casualty incidents ( MCIs ) , health care providers are often overwhelmed by large numbers of casualties .


An efficient , reliable , and affordable method of information collection is essential for effective health care response .


In some MCIs , self-reporting of symptoms can decrease the time required for history taking , without sacrificing the completeness of triage information .


Two resident doctors and a number of seventh graders who had previous experience of abdominal discomfort were invited to join this study .


A questionnaire was developed to collect information on common symptoms in food poisoning .


Each question was scored , and enrolled students were randomly divided into two groups .


The experimental group students answered the questionnaire first and then were interviewed to complete the medical history .


The control group students were interviewed in the traditional way to collect medical history .


Time of all interviews was measured and recorded .


The time needed to complete the history taking and completeness of obtained information were compared with students ' t tests , or Mann-Whitney U tests , based on the normality of data .


Comprehensibility of each question , scored by enrolled students , was reported by descriptive statistics .


There were @ students enrolled : @ in the experimental group and @ in the control group .


Time to complete history taking in the experimental group ( @ seconds , SD = @ ) was shorter than that in the control group ( @ seconds , SD = @ ) ( P = @ ) .


There was no difference in the completeness of history obtained between the experimental group and the control group ( @ % , SD = @ vs @ % , SD = @ ; P = @ ) .


Between the two doctors , no significant difference was found in the time required for history taking ( @ seconds , SD = @ vs @ seconds , SD = @ ; P = @ ) , or the completeness of information ( @ % , SD = @ vs @ % , SD = @ ; P = @ ) .


Most of the questions were scored `` good '' in comprehensibility .


Self-reporting of symptoms can shorten the time of history taking during a food poisoning mass-casualty event without sacrificing the completeness of information .


Clinical weight loss in individuals typically stabilizes at @ mo. .


However , validated models of dynamic energy balance have consistently shown weight plateaus between @ and @ y.


The cause for this discrepancy is unclear .


We developed @ mathematical models on the basis of the first law of thermodynamics to investigate plausible explanations for reaching an early weight plateau at @ mo. .


The first model was an energy-expenditure adaptation model and was applied to determine the degree of metabolic adaptation required to generate this plateau .


The second model was an intermittent lack-of-adherence model formulated by using a randomly fluctuating energy intake term accounting for intermittent noncompliance in dietary intake to reach this plateau .


To set model variables , validate models , and compare free-living weight-loss patterns to in-residence supervised programs , we applied the following @ different studies : The US NHANES @-@ , Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy ( CALERIE ) weight-loss study , the Bouchard Twin overfeeding study , and the Minnesota Starvation Experiment .


The metabolic adaptation model increased final weight but did not affect the predicted plateau time point .


The intermittent lack-of-adherence model generated oscillating weight graphs that have been frequently observed in weight-loss studies .


The model showed that a @-mo weight-loss plateau can be attained despite what can be considered as high diet adherence .


The model was programmed as a downloadable application .


An intermittent lack of diet adherence , not metabolic adaptation , is a major contributor to the frequently observed early weight-loss plateau .


The new weight-loss prediction software , which incorporates an intermittent lack of adherence , can be used to guide and inform patients on realistic levels of adherence on the basis of patient lifestyle .


Despite sincere commitment to egalitarian , meritocratic principles , subtle gender bias persists , constraining women 's opportunities for academic advancement .


The authors implemented a pair-matched , single-blind , cluster randomized , controlled study of a gender-bias-habit-changing intervention at a large public university .


Participants were faculty in @ departments or divisions at the University of Wisconsin-Madison .


Between September @ and March @ , experimental departments were offered a gender-bias-habit-changing intervention as a @-hour workshop .


Surveys measured gender bias awareness ; motivation , self-efficacy , and outcome expectations to reduce bias ; and gender equity action .


A timed word categorization task measured implicit gender/leadership bias .


Faculty completed a work-life survey before and after all experimental departments received the intervention .


Control departments were offered workshops after data were collected .


Linear mixed-effects models showed significantly greater changes post intervention for faculty in experimental versus control departments on several outcome measures , including self-efficacy to engage in gender-equity-promoting behaviors ( P = @ ) .


When @ % of a department 's faculty attended the workshop ( @ of @ departments ) , significant increases in self-reported action to promote gender equity occurred at three months ( P = @ ) .


Post intervention , faculty in experimental departments expressed greater perceptions of fit ( P = @ ) , valuing of their research ( P = @ ) , and comfort in raising personal and professional conflicts ( P = @ ) .


An intervention that facilitates intentional behavioral change can help faculty break the gender bias habit and change department climate in ways that should support the career advancement of women in academic medicine , science , and engineering .


In a study of @ chronic hepatitis B e antigen ( HBeAg ) - positive patients , @ experienced hepatitis B surface antigen ( HBsAg ) loss with up to @ years of tenofovir disoproxil fumarate ( TDF ) treatment .


HBsAg kinetics in patients with and without HBsAg loss and predictors of HBsAg loss were evaluated .


HBsAg levels were quantified every @ weeks .


A multivariable regression analysis , involving prespecified baseline characteristics and on-treatment response parameters , was performed ; a stepwise procedure identified independent predictors of HBsAg loss .


Among patients with HBsAg loss , @ ( @ % ) , @ ( @ % ) , @ and @ ( @ % ) were genotypes A through D , respectively ; @ ( @ % ) was genotype F. HBsAg loss was preceded by viral suppression ( HBV DNA < @ IU/ml ; n = @ ) and HBeAg loss ( n = @ ) .


Among treated patients the strongest independent predictors of HBsAg loss were Caucasian race with genotype A/D and @ years of infection ( HR = @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ; p < @ ) and an HBsAg decline of @ log@ IU/ml at week @ ( HR = @ , @ % CI @-@ @ ; p < @ ) .


Among TDF-treated patients , a reduction in HBsAg level of @-log@ by week @ or @ had a positive predictive value of @ % -@ % , respectively , and a negative predictive value of @ % -@ % , respectively .


HBsAg loss in HBeAg-positive patients receiving TDF involves a chronology of virologic and serologic responses ; patients with HBV genotypes A or D and a rapid early decline in HBsAg are more likely to lose HBsAg .


This is a secondary analysis of a randomized clinical trial which aims to examine changes in cognitive and behavioral responses to migraine with cognitive behavioral treatment for migraine , preventive medication for migraine , and their combination , and the relationship between these changes and reductions in migraine-related disability .


Cognitive behavioral treatment is thought to reduce migraine-related disability through modifying maladaptive cognitive and behavioral responses to migraine .


Two hundred thirty-two people with migraine who did not respond to @ weeks of optimized acute therapy were randomized into a @ ( beta-blocker vs placebo ) X @ ( behavioral migraine management -LSB- BMM -RSB- vs no BMM ) treatment design .


Participants received BMM and/or beta-blocker dose adjustment for @ months , and were followed for an additional @ months .


Participants completed measures of catastrophizing , behavioral coping , and migraine-related disability throughout the study .


Compared to drug therapy only , BMM demonstrated larger decreases in catastrophizing scores ( @ to @ vs @ to @ , P < @ ) and increases in number of positive coping strategies ( proactive : @ to @ vs @ to @ , P < @ ; anticipatory : @ to @ vs @ to @ , P < @ ; migraine management : @ to @ vs @ to @ , P < @ ) at the end of the follow-up period .


Decreases in catastrophizing were associated with a larger BMM effect on migraine-related disability ( P = @ ) .


This study demonstrated that BMM modified important cognitive and behavioral factors postulated to be mechanisms of cognitive behavioral treatments for migraine .


There is evidence from large clinical trials that compliance with standardized best practice guidelines ( BPGs ) improves survival of acute coronary syndrome ( ACS ) patients .


However , their application is often suboptimal .


In this study , the researchers evaluated whether the use of an interactive voice response ( IVR ) follow-up system improved ACS BPG compliance .


This was a single-centre randomized control trial ( RCT ) of @,@ patients ( IVR = @ ; usual care = @ ) .


The IVR group received five automated calls in @ months .


The primary composite outcome was increased medication compliance and decreased adverse events .


A significant improvement of @ % in the IVR group for the primary composite outcome was found ( RR @ , @ % CI : @ to @ , p < @ ) .


There was significant improvement in medication compliance ( p < @ ) and decrease in unplanned medical visits ( p = @ ) .


At one year , the majority of patients ( @ % ) responded positively to using the system again .


Follow-up by IVR produced positive outcomes in ACS patients .


Although a large isolated surface area of the left atrium ( LA ) may improve the success rate of catheter ablation ( CA ) for paroxysmal atrial fibrillation ( AF ) , little is known about the relation between clinical outcomes and the amount of atrial mass reduction ( AMR : ratio of total isolated and ablated areas to LA surface area ) in different ablation strategies for patients with long-standing persistent AF ( L-PeAF ) .


We randomly assigned @ consecutive L-PeAF patients to adjunctive linear ablation ( n = @ ) or complex fractionated atrial electrogram ( CFAE ) - guided ablation ( n = @ ) after circumferential antral pulmonary vein isolation ( PVI ) .


Linear lesions included roof and anterior lines with conduction block .


LA defragmentation was performed with an automated CFAE-detection algorithm .


Cavotricuspid isthmus block was performed in all patients .


Creatine kinase-MB ( CK-MB ) and troponin-T levels were measured @ day post-CA .


CK-MB and troponin-T levels were higher , ablation time was longer , and AMR was greater in the CFAE-guided ablation group than in the linear ablation group .


AF termination during CA was more frequently observed in the linear ablation group than in the CFAE-guided ablation group ( P = @ ) .


Twelve months after a single procedure , recurrence occurred in @ ( @ % ) patients with linear ablation and @ ( @ % ) patients with CFAE-guided ablation ( P = @ ) .


On multivariate analysis , LA volume and ablation method were the only independent risk factors for arrhythmia recurrence .


Conduction block through linear lines + PVI was an efficient ablation strategy for L-PeAF , whereas the AMR amount did not influence clinical outcomes .


Around @ % to @ % of older individuals fall each year , with adverse consequences of falls being by no means limited to physical injury and escalating levels of dependence .


Many older individuals suffer from a variety of adverse psychosocial difficulties related to falling including fear , anxiety , loss of confidence and subsequent increasing activity avoidance , social isolation and frailty .


Such ` fear of falling ' is common and disabling , but definitive studies examining the effective management of the syndrome are lacking .


Cognitive behavioural therapy has been trialed with some success in a group setting , but there is no adequately powered randomised controlled study of an individually based cognitive behavioural therapy intervention , and none using non-mental health professionals to deliver the intervention .


We are conducting a two-phase study examining the role of individual cognitive behavioural therapy delivered by healthcare assistants in improving fear of falling in older adults .


In Phase I , the intervention was developed and taught to healthcare assistants , while Phase II is the pragmatic randomised controlled study examining the efficacy of the intervention in improving fear of falling in community-dwelling elders attending falls services .


A qualitative process evaluation study informed by Normalization Process Theory is being conducted throughout to examine the potential promoters and inhibitors of introducing such an intervention into routine clinical practice , while a health economic sub-study running alongside the trial is examining the costs and benefits of such an approach to the wider health economy .


This study sought to determine whether the @-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents ( BMSs ) in the COMFORTABLE trial ( Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction ) were sustained during long-term follow-up .


A total of @ patients were randomly assigned to biolimus-eluting stent ( BES ) and BMS at @ centers , and follow-up rates at @ years were @ % .


A subgroup of @ patients underwent angiography at @ months .


At @ years , differences in the primary end point of cardiac death , target-vessel myocardial infarction , and target lesion revascularization continued to diverge in favor of BES-treated patients ( @ % ) compared with BMS-treated patients ( @ % ; hazard ratio = @ ; @ % confidence interval , @-@ @ ; P < @ ) with a significant risk reduction during the second year of follow-up ( hazard ratio @-@ years = @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Differences in the primary end point were driven by a reduction in target lesion revascularization ( @ % versus @ % ; P < @ ) and target-vessel reinfarction ( @ % versus @ % ; P = @ ) .


The composite of death , any reinfarction and revascularization ( @ % versus @ % ; P = @ ) , and cardiac death or target-vessel myocardial infarction ( @ % versus @ % ; P = @ ) were less frequent among BES-treated patients compared with BMS-treated patients .


The @-month angiographic in-stent percent diameter stenosis amounted to @ @ in BES - and @ @ in BMS-treated lesions ( P < @ ) .


Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , BES continued to improve cardiovascular events compared with BMS beyond @ year .


Ad@.CS @ is a pre-erythrocytic malaria candidate vaccine .


It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite ( CS ) surface antigen inserted in a replication deficient Adenovirus @ backbone .


A Phase @a trial has been conducted in the USA in nave adults and showed that the vaccine was safe .


The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa .


A double blind , randomized , controlled , dose escalation , phase Ib trial was conducted in a rural area of Balonghin , the Sapon health district ( Burkina Faso ) .


Forty-eight healthy adults aged @-@ years were randomized into @ cohorts of @ to receive three vaccine doses ( day @ , @ and @ ) of @ ( @ ) , @ ( @ ) , @X@ ( @ ) , @ ( @ ) vp of Ad@.CS @ or normal saline by intra muscular injection .


Subjects were monitored carefully during the @ days following each vaccination for non serious adverse events .


Severe and serious adverse events were collected throughout the participant study duration ( @ months from the first vaccination ) .


Humoral and cellular immune responses were measured on study days @ , @ , @ , @ , @ and @ .


Of the forty-eight subjects enrolled , forty-four ( @ % ) received all three scheduled vaccine doses .


Local reactions , all of mild severity , occurred in thirteen ( @ % ) subjects .


Severe ( grade @ ) laboratory abnormalities occurred in five ( @ % ) subjects .


One serious adverse event was reported and attributed to infection judged unrelated to vaccine .


The vaccine induced both antibody titers and CD@ T cells producing IFN and TNF with specificity to CS while eliciting modest neutralizing antibody responses against Ad@ .


Study vaccine Ad@.CS @ at four different dose levels was well-tolerated and modestly immunogenic in this population .


These results suggest that Ad@.CS @ should be further investigated for preliminary efficacy in human challenge models and as part of heterologous prime-boost vaccination strategies .


Diagnostic injections are used to diagnose myriad pain conditions , but are characterized by a high false-positive rate .


One potential cause of inaccurate diagnostic blocks is the use of sedation .


We sought to determine the effect of sedation on the validity of diagnostic injections .


Randomized , crossover study in which @ patients were allocated to receive a diagnostic sacroiliac joint or sympathetic nerve block performed either with or without sedation using midazolam and fentanyl .


Those who obtained equivocal relief , good relief lasting less than @ months , or who were otherwise deemed good candidates for a repeat injection , received a subsequent crossover injection within @ months ( N = @ ) .


A tertiary care teaching hospital and a military treatment facility .


In the primary crossover analysis , blocks performed with sedation resulted in a larger mean reduction in pain diary score than those done without sedation ( @ -LSB- @ -RSB- ; P = @ ) , less procedure-related pain ( difference in means @ -LSB- @ -RSB- ; P < @ ) , and a higher proportion of patients who obtained > @ % pain relief on their pain diaries ( @ % vs. @ % ; P = @ ) .


The increased pain reduction was not accompanied by increased satisfaction ( sedation mean @ -LSB- @ -RSB- vs. @ -LSB- @ -RSB- ; P = @ ) .


Similar findings were observed for the parallel group ( N = @ ) and omnibus ( all sedation vs. no sedation blocks , N = @ ) analyses .


No differences in outcomes were noted between the use and non-use of sedation at @-month .


The use of sedation during diagnostic injections may increase the rate of false-positive blocks and lead to misdiagnoses and unnecessary procedures , but has no effect on satisfaction or outcomes at @-month .


Biventricular pacing in heart failure ( HF ) improves survival , relieves symptoms , and attenuates left ventricular ( LV ) remodeling .


However , little is known about biventricular pacing in HF patients with atrioventricular block because they are typically excluded from biventricular trials .


The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block ( BLOCK HF ) trial randomized patients with atrioventricular block , New York Heart Association symptom classes I to III HF , and LV ejection fraction @ % to biventricular or right ventricular pacing .


Doppler echocardiograms were obtained at randomization ( after @ to @ days of right ventricular pacing postimplant ) and every @ months through @ months .


Data analysis comparing changes in @ prespecified echo parameters over time was conducted using a Bayesian design .