A total of @ voluntary adolescents from Spain and Mexico were recruited between @ and @ and randomly assigned to : one control group and two experimental groups , which received exclusively the online intervention ( experimental group @ ) or the intervention supplemented with encouraging text messages ( experimental group @ ) .


The educational intervention was based on both : successful psychosocial models ( i.e. A.S.E. and Transtheoretical model ) and the school curriculum .


After a @-month follow-up , the prevalence of students who did not eat fruit was reduced significantly in all groups : experimental group @ ( -@ % ) , experimental group @ ( -@ % ) and even the control group ( -@ % ) .


Being overweight was only reduced in the experimental group @ ( -@ % ) .


The total cancer behavioral risk score , which ranged from @ to @ points ( highest risk ) , was significantly reduced in the experimental group @ ( -@ points ) and in the experimental group @ ( -@ points ) .


The text-supplemented online intervention increased the probability of improving the post-test total cancer behavioral risk ( OR = @ ) .


The web-based intervention supplemented with text messages had a positive global impact , but it lead to only minimal changes in risky behaviors .


This intervention appears useful in controlling overweight adolescents .


To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery .


Prospective multicentric randomized double-blind study .


Tertiary care centre , University Hospitals of Brescia and Torino , Italy .


Eighty-seven singleton pregnancies without uterine contractions and ultrasonographic cervical length of @mm at @-@weeks , at risk for preterm delivery , with longitudinal follow up in our Preterm Prevention Clinic .


Selection was done on the basis of ultrasonographic cervical length ; @ women were randomized to receive placebo and @ to receive nifedipine .


Primary end point : spontaneous preterm delivery < @weeks in nifedipine vs. placebo .


delivery < @weeks , maternal side effects , neonatal complications , admissions to the Neonatal Intensive Care Unit and randomization/delivery time in nifedipine vs. placebo .


There was no trend towards a lower risk of spontaneous preterm delivery , neither at < @weeks of nifedipine vs. placebo ( @ % vs. @ % ; p = @ ) , or < @weeks ( @ % vs. @ % ; p = @ ) .


Nifedipine reduced spontaneous preterm delivery < @weeks ( p = @ ) in the multiparous women by stratified analysis for parity .


SECONDARY OUTCOMES between the groups did not differ except for a higher percentage of maternal side-effects in the nifedipine group ( @ % ) vs. placebo ( @ % ) ( p < @ ) .


Subgroup analysis showed a borderline ( p = @ ) lower percentage of spontaneous preterm delivery in women with a ultrasonographic cervical length of < @mm in the nifedipine group .


Prophylactic nifedipine in asymptomatic women at high risk for preterm delivery had a positive effect on the rate of spontaneous preterm delivery < @weeks in multiparous women .


We compared the activity of denosumab with zoledronic acid for delaying or preventing hypercalcaemia of malignancy ( HCM ) in patients with advanced cancer and bone metastases or with multiple myeloma .


Patient-level data were combined from two identically designed , randomised , double-blind , active-controlled , phase III trials of advanced cancer patients with breast cancer and other solid tumours ( excluding breast or prostate cancer ) or multiple myeloma .


End-points included time to first on-study HCM , time to first and subsequent on-study HCM , proportion of patients experiencing HCM and proportion of patients experiencing recurrent HCM .


Denosumab significantly delayed the time to first on-study HCM , representing a @ % reduction in the hazard ratio ( HR ) compared with zoledronic acid ( HR , @ ; @ % confidence interval ( CI ) : @-@ @ ; P = @ ) and reduced the risk of developing recurrent HCM ( time to first and subsequent on-study HCM ) by @ % ( rate ratio , @ ; @ % CI : @-@ @ ; P = @ ) .


The median time on study was @ months .


Fewer patients receiving denosumab compared with zoledronic acid experienced an HCM event ( @ % versus @ % ; P = @ ) .


Of the @ patients experiencing an HCM event , @ % of those receiving zoledronic acid experienced > @ event of HCM compared with @ % of those receiving denosumab .


Denosumab treatment was more efficacious than treatment with zoledronic acid in delaying or preventing HCM in advanced cancer patients with breast cancer , other solid tumours or multiple myeloma .


Malignant pleural mesothelioma incidence continues to rise , with few available evidence-based therapeutic options .


Results of previous non-randomised studies suggested that video-assisted thoracoscopic partial pleurectomy ( VAT-PP ) might improve symptom control and survival .


We aimed to compare efficacy in terms of overall survival , and cost , of VAT-PP and talc pleurodesis in patients with malignant pleural mesothelioma .


We undertook an open-label , parallel-group , randomised , controlled trial in patients aged @ years or older with any subtype of confirmed or suspected mesothelioma with pleural effusion , recruited from @ hospitals in the UK .


Eligible patients were randomly assigned ( @:@ ) to either VAT-PP or talc pleurodesis by computer-generated random numbers , stratified by European Organisation for Research and Treatment of Cancer risk category ( high vs low ) .


The primary outcome was overall survival at @ year , analysed by intention to treat ( all patients randomly assigned to a treatment group with a final diagnosis of mesothelioma ) .


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


Between Oct @ , @ , and Jan @ , @ , we randomly assigned @ patients , of whom @ ( @ assigned to talc pleurodesis , @ assigned to VAT-PP ) had confirmed mesothelioma .


Overall survival at @ year was @ % ( @ % CI @-@ ) in the VAT-PP group and @ % ( @-@ ) in the talc pleurodesis group ( hazard ratio @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


Surgical complications were significantly more common after VAT-PP than after talc pleurodesis , occurring in @ ( @ % ) of @ patients who completed VAT-PP versus ten ( @ % ) of @ patients who completed talc pleurodesis ( p = @ ) , as were respiratory complications ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; p = @ ) and air-leak beyond @ days ( five -LSB- @ % -RSB- vs one -LSB- @ % -RSB- ; p = @ ) , although not significantly so .


Median hospital stay was longer at @ days ( IQR @-@ ) in patients who received VAT-PP compared with @ days ( @-@ ) for those who received talc pleurodesis ( p < @ ) .


VAT-PP is not recommended to improve overall survival in patients with pleural effusion due to malignant pleural mesothelioma , and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment .


To compare the effects of @ suturing techniques ( single versus double layer ) on healing of the uterine scar after a cesarean delivery .


In the present randomized , prospective study , @ women with a term pregnancy who had an elective cesarean delivery were randomly assigned to closure of the uterine incision with a single-layer locked suture or with a double-layer locked/unlocked suture .


Six months after the operation , the integrity of the cesarean scar at the uterine incision site was assessed by hydrosonography .


The healing ratio and the thickness of the residual myometrium covering the defect were calculated as markers of uterine scar healing .


There were no significant differences between the groups in terms of estimated blood loss , operation time , or additional hemostatic suture .


However , the mean thickness of the residual myometrium covering the defect was @ @ mm after a double-layer closure and @ @ mm after a single-layer closure ( P = @ ) .


The mean healing ratio was significantly higher after a double-layer closure ( @ @ ) than after a single-layer closure ( @ @ ; P = @ ) .


A double-layer locked/unlocked closure of the uterine incision at cesarean delivery decreases the risk of poor uterine scar healing .


To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV ( PLWH ) .


Prospective , randomized controlled trial .


HIV-care center in the Bronx , New York .


Eligibility criteria included HIV infection , current tobacco usage , interest in quitting , and access to a computer with internet .


One hundred thirty-eight subjects enrolled , and @ completed the study .


Positively Smoke Free on the Web ( PSFW ) , an @-session , @-week targeted tobacco treatment program for PLWH , was compared with standard care ( brief advice to quit and self-help brochure ) .


All subjects were offered nicotine patches .


The main feasibility outcomes were number of sessions logged into , number of Web pages visited , number of interactive clicks , and total time logged in .


The main efficacy outcome was biochemically verified , @-day point prevalence abstinence @ months after intervention .


PSFW subjects logged into a mean of @ of @ sessions and @ of @ pages .


They executed a mean of @ interactive clicks during a mean total of @ minutes logged in .


Most required reminder phone calls to complete the sessions .


Educational level , anxiety score , and home access of the Web site were associated with Web site usage .


Ten percent of the PSFW group vs. @ % of controls achieved the abstinence end point .


Among those who completed all @ sessions , @ % were abstinent , and among women completers , @ % were abstinent .


Web-based treatment is a feasible strategy for PLWH smokers , and preliminary findings suggest therapeutic efficacy .


Some studies have shown the beneficial effects of yoga for individuals with bronchial hyperreactivity with regard to ( @ ) a reduction in the use of rescue medication , ( @ ) an increase in exercise capacity , and ( @ ) an improvement in lung function .


Despite the fact that yoga is promising as a new treatment for pediatric patients , further studies are needed to assess the use of this training for asthma management .


This study was performed to assess the beneficial effects of yoga in exercise-induced bronchoconstriction ( EIB ) in children .


The study was prospective , with no control group .


Participants were randomly chosen among the new patients at the unit .


This study was conducted in the Erciyes University School of Medicine , Pediatric Allergy Unit , in Kayseri , Turkey .


Two groups of asthmatic children aged @-@ y were enrolled in the study : ( @ ) children with positive responses to an exercise challenge ( n = @ ) , and ( @ ) those with negative responses ( n = @ ) .


Both groups attended @-h sessions of yoga training @ / wk for @ mo. .


Researchers administered spirometric measurement to all children before and immediately after participating in an exercise challenge .


This process was performed at baseline and at the study 's end .


Age , gender , IgE levels , eosinophil numbers , and spirometric measurement parameters including forced expiratory volume in @ sec ( FEV@ ) , forced expiratory flow @ % -@ % ( FEF@ % -@ % ) , forced vital capacity ( FVC ) , peak expiratory flow percentage ( PEF % ) , and peak expiratory flow rate ( PEFR ) were compared using the Mann-Whitney U test and the Wilcoxon test .


A P value < @ was considered significant .


At baseline , no significant differences were observed between the groups regarding demographics or pre-exercise spirometric measurements ( P > @ , Mann-Whitney U test ) .


Likewise , no significant differences in spirometric measurements existed between the groups regarding the change in responses to an exercise challenge after yoga training ( P > @ , Wilcoxon test ) .


For the exercise-response-positive group , the research team observed a significant improvement in maximum forced expiratory volume @ % ( FEV@ % ) fall following the exercise challenge after yoga training ( P > @ , Wilcoxon test ) .


All exercise-response-positive asthmatics became exerciseresponse-negative asthmatics after yoga training .


This study showed that training children in the practice of yoga had beneficial effects on EIB .


It is the research team 's opinion that yoga training can supplement drug therapy to achieve better control of asthma .


The aim of this study was to compare the recurrence of esophageal varices ( EVs ) after endoscopic band ligation ( EBL ) associated with propranolol ( PP ) versus EBL alone .


Sixty-six cirrhotic outpatients ( EBL group , n = @ and EBL+PP group , n = @ ) with high-risk EVs without previous bleeding were studied .


The primary outcome was recurrence of EV .


The secondary outcomes were EV eradication , bleeding before EV eradication , mortality , and adverse events .


Demographic characteristics and the initial endoscopic findings were similar .


EV eradication was achieved in all patients .


Three patients presented gastrointestinal bleeding before variceal eradication , two in the EBL group and one in the EBL+PP group ( P = @ ) .


Six patients died ( liver failure ) , two in the EBL group and four in the EBL+PP group ( P = @ ) .


Twelve ( @ % ) patients in the EBL group and three ( @ % ) patients in the EBL+PP group had variceal recurrence .


The risk of recurrence of EVs after eradication was significantly higher among patients in the EBL group ( P = @ ) .


EBL alone and EBL+PP were effective in the primary prophylaxis of bleeding from EVs in cirrhotic patients ( EV eradication , bleeding before EV eradication , mortality , and adverse events were similar in both groups ) .


However , variceal recurrence was lower in the EBL+PP group than band ligation alone .


Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability .


To date , there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation ( TENS ) in the management of pain and improvement in function in individuals with fibromyalgia .


The purpose of this study will be to complete a long-term , multicenter study to assess the effects of TENS in women with fibromyalgia .


This will be a phase II randomized , double-blind , placebo-controlled , multicenter clinical trial .


Three hundred forty-three participants with fibromyalgia will be recruited for this study .


Participants will be randomly assigned to @ of @ groups : the intervention ( TENS ) , placebo , or no treatment .


After completing the randomized period , all participants will receive the intervention for @ month .


The participants will be asked to use TENS at the highest tolerable level for at least @ hours daily during physical activity .


The primary outcome will be pain with movement , with secondary outcomes assessing functional abilities , patient-reported outcomes , and quantitative sensory testing .


Because having participants refrain from their typical medications is not practical , their usage and any change in medication use will be recorded .


The results of this study will provide some of the first evidence from a large-scale , double-blind , placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia .


In Sub-Saharan Africa over one million newborns die annually .


We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival .


Here we report the effect on newborn care practices one year after full implementation .


All @ wards in the @-district study area were randomised to intervention or comparison groups .


Starting in @ , in intervention areas trained volunteers made home visits during pregnancy and after childbirth to promote recommended newborn care practices including hygiene , breastfeeding and identification and extra care for low birth weight babies .


In @ , in a representative sample of @,@ households , we asked women who had given birth in the previous year both about counselling visits and their childbirth and newborn care practices .


Four of @ newborn care practices were more commonly reported in intervention than comparison areas : delaying the baby 's first bath by at least six hours ( @ % versus @ % , OR @ ( @ % CI @-@ @ ) ) , exclusive breastfeeding in the three days after birth ( @ % versus @ % , OR @ ( @ % CI @-@ @ ) ) , putting nothing on the cord ( @ % versus @ % , OR @ ( @ % CI @-@ @ ) ) , and , for home births , tying the cord with a clean thread ( @ % versus @ % , OR @ ( @ % CI @-@ @ ) ) .


For other behaviours there was little evidence of differences in reported practices between intervention and comparison areas including childbirth in a health facility or with a skilled attendant , thermal care practices , breastfeeding within an hour of birth and , for home births , the birth attendant having clean hands , cutting the cord with a clean blade and birth preparedness activities .


A home-based counselling strategy using volunteers and designed for scale-up can improve newborn care behaviours in rural communities of southern Tanzania .


Further research is needed to evaluate if , and at what cost , these gains will lead to improved newborn survival .


To investigate the relationships between AMG @ exposure , concentration changes in serum IFN - , and IFN -- induced protein @ ( CXCL@ ) , and to identify important contributions of baseline covariates to these relationships .


A mechanism based pharmacokinetic ( PK ) - pharmacodynamic ( PD ) model was developed .


A target mediated disposition model was used to describe AMG @ and target IFN - interaction .


CXCL@ was predicted to be driven by estimated free IFN - levels .


For an average systemic lupus erythematosus ( SLE ) subject , the linear clearance ( CL ) of AMG @ was @ L/day , and the central ( Vc ) and peripheral ( Vp ) volumes of distribution were @ and @ L , respectively .


Body weight was found to correlate with CL , Vc , Vp , and inter compartment clearance ( Q ) ; and age was found to correlate with Vc .


The relationship between estimated free serum IFN - concentration levels and serum CXCL@ in logarithmic scales was best described by a linear model with slope and intercept estimated to be @ and -@ , respectively .


The largest observed reduction of serum CXCL@ concentration was achieved at the highest AMG @ dose tested ( @ mg SC ) .


This model enables simulations of AMG @ PK-PD profiles under various dosing regimens to support future clinical studies .


We evaluated whether stress levels in children and parents during radiological evaluation after febrile urinary tract infection are really lower using the top-down approach , where ( @m ) technetium dimercaptosuccinic acid renal scintigraphy is used initially , than the bottom-up approach , where voiding cystourethrography is initially performed and repeated examinations are easier for all .


We prospectively evaluated @ children @ to @ years old .


Pain ratings were obtained using the Faces Pain Scale-Revised , and conversation during the procedure was evaluated using the Child-Adult Medical Procedure Interaction Scale-Revised by @ independent observers .


To evaluate parental anxiety , the State-Trait Anxiety Inventory form was also completed .


Following a documented febrile urinary tract infection children were randomized to the top-down or bottom-up group .


A third group of @ children undergoing repeat voiding cystourethrography and their parents were also evaluated .


Child ratings of pain using the Faces Pain Scale-Revised were not significantly different between the top-down group following ( @m ) technetium dimercaptosuccinic acid renal scintigraphy ( @ on a scale of @ ) and the bottom-up group following voiding cystourethrography ( @ ) .


Also the Faces Pain Scale-Revised was not significantly different in the repeat voiding cystourethrography group ( @ ) .


On the Child-Adult Medical Procedure Interaction Scale-Revised there was negative correlation between child coping and child distress , as well as rate of child distress and adult coping promoting behavior .


Parental state anxiety scores were significantly less in the top-down and repeat voiding cystourethrography groups than in the bottom-up group .


Although the top-down approach and repeat voiding cystourethrography cause less anxiety for caregivers , these values do not correlate to pain scale in children .


This finding might be due to lack of appropriate evaluation tools of pediatric pain and anxiety .


However , the theory that the top-down approach is less invasive , and thus less stressful , requires further research .


The Child-Adult Medical Procedure Interaction Scale-Revised data indicate that influences in adult-child interaction are bidirectional .


Atelectasis is common during and after general anaesthesia .


We hypothesized that a ventilation strategy with a combination of @ ) continuous positive airway pressure ( CPAP ) or positive end-expiratory pressure ( PEEP ) and @ ) a reduced end-expiratory oxygen concentration during recovery would reduce post-operative atelectasis .


Sixty patients were randomized into two groups .


During anaesthesia induction , inspiratory oxygen fraction ( FIO@ ) was @ , and depending on weight , CPAP @ , @ or @ cmH@O was applied in both groups via facemask .


During maintenance of anaesthesia , a laryngeal mask airway ( LMA ) was used , and PEEP was @-@ cmH@O in both groups .


Before removal of the LMA , FIO@ was set to @ in the intervention group and @ in the control group .


Atelectasis was studied by computed tomography ( CT ) approximately @ min post-operatively .


In one patient in the group given an FIO@ of @ before removal of the LMA a CT scan could not be performed so the patient was excluded .


The area of atelectasis was @ , @-@ @ cm ( @ ) ( median and range ) , and @ , @-@ @ cm ( @ ) in the groups given FIO@ @ or FIO@ @ before removal of the LMA , a difference that was not statistically significant ( P = @ ) .


Post-hoc analysis showed dependence of atelectasis on smoking ( despite all were clinically lung healthy ) and American Society of Anesthesiologists class ( P = @ and @ , respectively ) .


Inducing anaesthesia with CPAP/PEEP and FIO@ @ and deliberately reducing FIO@ during recovery before removal of the LMA did not reduce post-operative atelectasis compared with FIO@ @ before removal of the LMA .


A classic general anesthesia is performed by induction with an intravenous hypnotic ( such as propofol ) and maintenance with a volatile anesthetic ( such as sevoflurane ) .


The aim of the present study was to compare the effects of a propofol/sevoflurane maintenance regimen with that of a sevoflurane regimen on recovery profiles .


One hundred and sixty patients , who were ASA @ or @ , @-@ years of age , and scheduled for elective gastrointestinal surgery under combined general/epidural anesthesia , were allocated randomly to receive the sevoflurane maintenance regimen ( group S , n = @ ) or sevoflurane/propofol regimen ( group SP , n = @ ) .


After induction , anesthesia was maintained with sevoflurane in group S and sevoflurane with propofol ( @ g/ml target plasma concentration ) in group SP .


Bispectral index ( BIS ) values were maintained within @-@ during the maintenance .


Time to extubation , incidence of serious coughing and agitation , and other recovery characteristics were evaluated during emergence .


The time to awakening and extubation in group SP were @ @ min and @ @ min , respectively , which were shorter than those results in group S ( @ @ and @ @ min , respectively ) ( P < @ ) .


The incidence of serious coughing and agitation in SP ( @ % and @ % ) was lower than that of group S ( @ % and @ % ) ( P < @ ) .


BIS value , pain score , requirements of analgesics and antiemetics in the PACU , and length of stay in the PACU were similar in the two groups .


Compared to sevoflurane maintenance , coadministration of propofol and sevoflurane provides faster awakening and extubation with a low incidence of emergence coughing and agitation .


To compare two intrathecal anaesthetics , bupivacaine and levobupivacaine , for their effects on motor and sensory blockade and haemodynamics in patients aged @ years undergoing transurethral resection of the prostate ( TUR-P ) or transurethral resection of the urinary bladder ( TUR-M ) .


Patients scheduled to undergo TUR-P or TUR-M were randomized to receive either @ ml ( @ mg ) @ % isobaric levobupivacaine ( group L ) or @ ml ( @ mg ) of @ % hyperbaric bupivacaine ( group B ) for spinal anaesthesia .


The onset time , maximum level and time to reach the maximum level of sensory and motor blockade were recorded .


Changes to haemodynamic parameters were also recorded .


The study randomized @ patients : @ to group L and @ to group B. Levobupivacaine did not cause any significant changes in haemodynamic parameters , including systolic blood pressure , and showed a similar sensory block onset time compared with bupivacaine , but it had a significantly longer motor block onset time compared with bupivacaine .


These current findings suggest that levobupivacaine can be used as a substitute for bupivacaine for spinal anaesthesia in elderly patients @ years of age undergoing elective TUR-P or TUR-M operations .


Breast reconstruction aims to improve health-related quality of life after mastectomy .


However , evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking .


QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely ( QUEST A ) or highly probable ( QUEST B ) .


The primary endpoint for the feasibility phase was the proportion of women who accepted randomization , and it would be considered feasible if patient acceptability rates exceeded @ per cent of women approached .


A companion QUEST Perspectives Study ( QPS ) of patients ( both accepting and declining trial participation ) and healthcare professionals assessed trial acceptability .


The QUEST trials opened in @ UK centres .


After @ months of recruitment , @ patients were randomized to QUEST A and eight to QUEST B , with overall acceptance rates of @ per cent ( @ of @ ) and @ per cent ( @ of @ ) respectively .


The QPS recruited @ patients and @ healthcare professionals .


Patient preference was the predominant reason for declining trial entry , given by @ ( @ per cent ) of the @ patients approached for QUEST A and @ ( @ per cent ) of the @ approached for QUEST B. Both trials closed to recruitment in December @ , acknowledging the challenges of achieving satisfactory patient accrual .


Despite extensive efforts to overcome recruitment barriers , it was not feasible to reach timely recruitment targets within a feasibility study .


Patient preferences for breast reconstruction types and timings were common , rendering patients unwilling to enter the trial .


The depressor septi nasi muscle is responsible for smiling deformity .


Its manipulation is beneficial in patients with muscle hypertrophy .


In addition , it enhances the smile and tip-lip relationship .


In this study , depressor septi nasi muscle excision through a transfixion incision is compared with its transposition through an upper labial sulcus incision .


Two techniques of depressor septi nasi muscle treatment were performed randomly for rhinoplasty cases .


Smile analysis in rhinoplasty , consisting of measurements of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and full smile , was performed on preoperative and postoperative photographs .


One hundred patients were studied in two equal groups .


Preoperatively , tip projection and upper lip height were decreased significantly with smiling .


Generally , the effect of smiling on all five parameters was decreased significantly following rhinoplasty .


The two different techniques were not significantly different in decreasing the effects of smiling on nasal length , nasal diagonal , tip projection , upper lip height , or transverse crease .


The two different techniques were the same in decreasing the effects of smiling .


The authors recommend smile analysis in rhinoplasty , consisting of measurement of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and during smiling , before rhinoplasty for preoperative evaluation and after the operation for outcome assessment .


Depressor septi nasi muscle treatment should be considered if a decrease in tip projection or upper lip height with smiling or a transverse upper labial crease during smiling is extraordinary or unsightly .


Therapeutic , II .


Somatosensory stimulation ( SS ) is a potential adjuvant to stroke rehabilitation , but the effect on function needs further investigation .


To explore the effect of combining SS with task-specific training ( TST ) on upper limb function and arm use in chronic stroke survivors and determine underlying mechanisms .


In this double-blinded randomized controlled trial ( ISRCTN @ ) , @ patients ( mean @ months poststroke ) were block randomized to @ groups : active or sham SS .


They received @ sessions of @ hours of SS ( active or sham ) to all @ upper limb nerves immediately before @ minutes of TST .


The primary outcome was the Action Research Arm Test ( ARAT ) score .


Secondary outcomes were time to perform the ARAT , Fugl-Meyer Assessment score ( FM ) , Motor Activity Log ( MAL ) , and Goal Attainment Scale ( GAS ) .


Underlying mechanisms were explored using transcranial magnetic stimulation stimulus-response curves and intracortical inhibition .


Outcomes were assessed at baseline , immediately following the intervention ( mean @ days ) , and @ and @ months ( mean @ and @ days ) after the intervention .


The active group ( n = @ ) demonstrated greater improvement in ARAT score and time immediately postintervention ( between-group difference ; P < @ ) , but not at @ - or @-month follow-ups ( P > @ ) .


Within-group improvements were seen for both groups for ARAT and GAS , but for the active group only for FM and MAL ( P < @ ) .


Corticospinal excitability did not change .


Long-lasting improvements in upper limb function were observed following TST .


Additional benefit of SS was seen immediately post treatment , but did not persist and the underlying mechanisms remain unclear .


There is current interest in the maternal-fetal effects of antenatal vitamin D supplementation , yet little data regarding vitamin D 's role in neonatal calcium homeostasis .


We determined to assess the effect of high-dose antenatal vitamin D supplementation on fetal and neonatal calcium concentrations .


In a double-blinded , placebo-controlled trial in Bangladesh , @ pregnant women were randomized to oral vitamin D@ ( @,@ IU/wk ) or placebo from @ to @wk of gestation .


Total serum calcium ( Ca ) was higher in cord blood of those supplemented vs. placebo ( @ vs. @ mmol/l ; P = @ ) , but the difference in albumin-adjusted calcium was not statistically significant .


Change in Ca concentration from birth to day @ of life was attenuated by vitamin D ( -@ ) compared with placebo ( -@ mmol/l ; P = @ ) .


Maternal @-hydroxyvitamin D ( @ ( OH ) D ) ( P = @ ) and cord @ ( OH ) D ( P < @ ) were associated with day @ infant Ca , suggesting that the effect of supplementation was mediated by change in maternal-infant vitamin D status .


Six infants in each of the supplemented and placebo groups had transient hypercalcemia/hypercalcuria ; in all the hypercalcemia/hypercalcuria was asymptomatic , spontaneously resolved , and unassociated with nephrocalcinosis at @ mo of life .


High-dose antenatal third-trimester vitamin D supplementation attenuated the early postnatal calcium nadir , without increasing the risk of postnatal hypercalcemia .


Patients on chronic dialysis are at increased risk of vitamin D deficiency .


In observational studies plasma @-hydroxyvitamin D ( p-@ ( OH ) D ) levels are inversely correlated with plasma BNP and adverse cardiovascular outcomes .


Whether a causal relation exists has yet to be established .


The aim of this study was to test the hypothesis that cholecalciferol supplementation improves cardiac function and reduces blood pressure ( BP ) and pulse wave velocity ( PWV ) in patients on chronic dialysis .


In a randomized , placebo-controlled , double-blind study , we investigated the effect of @ g ( @ IU ) cholecalciferol daily for @ months , in patients on chronic dialysis .


We performed two-dimensional echocardiography , with doppler and tissue-doppler imaging , @-h ambulatory BP ( @-h BP ) , PWV , augmentation index ( AIx ) , central BP ( cBP ) and brain natriuretic peptide ( BNP ) measurements at baseline and after @ months .


Sixty-four patients were allocated to the study .


Fifty dialysis patients with a mean age of @ years ( range : @-@ ) and baseline p-@ ( OH ) D of @ ( @ ; @ ) nmol/l completed the trial .


Cholecalciferol increased left ventricular ( LV ) volume , but had no impact on other parameters regarding LV structure or left atrial structure .


LV systolic function , LV diastolic function , PWV , cBP , AIx and BNP were not changed in placebo or cholecalciferol group at follow-up .


@-h BP decreased significantly in placebo group and tended to decrease in cholecalciferol group without any difference between treatments .


Six months of cholecalciferol treatment in patients on chronic dialysis did not improve @-h BP , arterial stiffness or cardiac function .


Excessive use of short-acting @-agonists ( SABA ) indicates impaired asthma control .


To determine whether real-time outreach to excessive SABA users reduces SABA canister dispensings .


After real-time determination of a seventh SABA canister dispensing in the prior @ months by using informational pharmacy technology , @ to @ year old patients with physician-coded asthma and inhaled corticosteroid dispensing were block randomized by prior asthma specialist care and medication step-care level into intervention ( n = @ ) and control groups ( n = @ ) .


Intervention included real-time letter notification to patients and an electronic message to their physician with management suggestions , including facilitated allergy referral for patients without prior asthma specialist care .


The control group received this organization 's standard asthma care management without research contact .


Frequency of the seventh SABA canister dispensing in the follow-up year was the primary outcome .


Compared with controls , intervention patients reached @ SABA canister dispensings less frequently ( @ % vs @ % ; risk ratio @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) and later ( hazard ratio @ -LSB- @ % CI , @-@ @ ; P < @ ) .


SABA canister dispensings ( mean SD ) were less in intervention ( @ @ canisters ) than controls ( @ @ canisters ) ( rate ratio @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


The intervention reduced the risk of @ SABA canister dispensings in patients without specialist care compared with patients with specialist care in the prior @ years ( P < @ ) ( P = @ for interaction by prior specialist care ) .


Visits to allergists were more frequent for intervention patients ( @ % ) than for control patients ( @ % ) ( risk ratio @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


Asthma exacerbations were unaffected .


A novel administrative-based asthma outreach program improves markers of asthma impairment in patients without prior asthma specialist care and is adaptable to managed care organizations with electronic medical records .


To minimize stent-related symptoms , the proximal part of the Polaris stent is composed of a firm material and its distal part is composed of a soft material .


The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life .


A total of @ patients were randomized to a `` test '' group ( Polaris ; n = @ ) or a `` conventional '' group ( Percuflex ; n = @ ) at the time of ureteral stent insertion after ureteroscopic stone removal surgery .


Stents were allocated using a randomization program .


At @ week postoperatively , patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire ( USSQ ) , and patients were asked complete a @cm visual analogue scale ( VAS ) .


Mean scores for USSQ domains and mean VAS scores were compared .


Mean patient age was @ years , and the male-to-female ratio was @:@ .


No significant intergroup differences were found in the domain scores of urinary symptoms ( P = @ ) , pain ( P = @ ) , general health ( P = @ ) , work ( P = @ ) , sexual activity ( P = @ ) , or additional problems ( P = @ ) .


In addition , VAS scores were nonsignificantly different ( P = @ ) .


Analysis of USSQ item scores , however , revealed the test group had better results for `` presence of pain , '' `` frequency of pain killer use , '' `` difficulties with respect to hard physical activity , '' `` fatigue , '' `` frequency of rest , '' `` stent-related impact on work , '' `` antibiotics use '' than the conventional group except for `` outpatient department visits '' .


Compared with the conventional Percuflex ureteral stent , the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms , pain , general health , sexual matters , or additional problems as determined by the USSQ or in VAS determined pain .


Sub-analysis , however , showed that the Polaris has some advantages with respect to pain , physical activities , impact on work , and additional problems .


Accordingly , the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent .


To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes .


In an @-week randomized controlled trial among women aged @-@ years , sexual function was compared between @ mg oral estradiol per day or @ mg venlafaxine per day ( both compared with a placebo ) .


Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress .


Participants were aged @ years ( standard deviation -LSB- SD -RSB- @ ) years , @ % white , with @ ( SD @ ) daily hot flushes .


Median composite baseline Female Sexual Function Index score was @ ( SD @ , n = @ ) for all women and @ ( SD @ , n = @ ) among sexually active women .


Composite mean Female Sexual Function Index change from baseline to week @ was @ ( @ % confidence interval -LSB- CI -RSB- -@ to @ ) for estradiol , @ ( @ % CI -@ to @ ) for venlafaxine , and -@ ( @ % CI -@ to @ ) for placebo .


Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo ( P = @ , P = @ ) or venlafaxine and placebo ( P = @ , P = @ ) .


Among sexually active women , Female Sexual Function Index domain score change from baseline differences ( active compared with placebo ) in desire was @ ( @ % CI @-@ @ ) for estradiol , -@ ( @ % CI -@ to @ ) in orgasm for venlafaxine , and @ ( @ % CI @-@ @ ) in penetration pain for venlafaxine .


No women reported adverse events related to sexual dysfunction .


Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over @ weeks with low-dose oral estradiol or venlafaxine ( compared with placebo ) , although a subtle increase in desire ( estradiol ) and decreases in orgasm and pain ( venlafaxine ) may exist .


Maternal depression carries a major public health burden for mothers and their infants , yet there is a substantial treatment gap for this condition in low-resourced regions such as sub-Saharan Africa .


To address this treatment gap , the strategy of `` task sharing '' has been proposed , involving the delivery of interventions by non-specialist health workers trained and supervised by specialists in routine healthcare delivery systems .


Several psychological interventions have shown benefit in treating maternal depression , but few have been rigorously evaluated using a task sharing approach .


The proposed trial will be the first randomised controlled trial ( RCT ) evaluating a task sharing model of delivering care for women with maternal depression in sub-Saharan Africa .


The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa .


The study is an individual-level two-arm RCT .


A total of @ depressed pregnant women will be recruited from two ante-natal clinics in a low-income township area of Cape Town , using the Edinburgh Postnatal Depression Scale to screen for depression ; @ women will be randomly allocated to each of the intervention and control arms .


The intervention group will be given six sessions of basic counseling over a period of @ to @ months , provided by trained community health workers ( CHW ) s.


The control group will receive three monthly phone calls from a CHW trained to conduct phone calls but not basic counseling .


The primary outcome measure is the @-Item Hamilton Depression Rating Scale ( HDRS-@ ) .


The outcome measures will be applied at the baseline assessment , and at three follow-up points : @ month before delivery , and @ and @ months after delivery .


The primary analysis will be by intention-to-treat and secondary analyses will be on a per protocol population .


The primary outcome measure will be analyzed using linear regression adjusting for baseline symptom severity measured using the HDRS-@ .


The findings of this trial can provide policy makers with evidence regarding the effectiveness and cost-effectiveness of structured psychological interventions for maternal depression delivered by appropriately trained and supervised non-specialist CHWs in sub-Saharan Africa .


We aimed to explore the specific effects of mindfulness-based stress reduction ( MBSR ) for urban youth by comparing it with an active control program , designed to control for time , positive peer-group experience , and positive adult instructor .


Patients between the ages of @-@ years who received primary pediatric care at our urban outpatient clinic were eligible for study participation .


Those who were interested were consented and randomly assigned to an eight-week program of MBSR or Healthy Topics ( HT ) , a health education curriculum .


To increase sensitivity to outcomes of interest , mixed methods were used to assess psychological symptoms , coping , and program experience .


Analysis of variance and regression modeling were used ; interviews were audio-taped , transcribed , and coded for key themes .


A total of @ ( @ MBSR , @ HT ) youths attended one or more sessions , of whom @ -LSB- @ MBSR ( @ % ) , @ HT ( @ % ) -RSB- attended the majority of the sessions and were considered completers .


Program completers were African American , @ % female , with average age of @ years .


Statistical analysis of survey data did not identify significant post-program differences between groups .


Qualitative data show comparable positive experiences in both programs , but specific differences related to MBSR participants use of mindfulness techniques to calm down and avoid conflicts , as well as descriptions of internal processes and self-regulation .


Compared with an active control program , MBSR did not result in statistically significant differences in self-reported survey outcomes of interest but was associated with qualitative outcomes of increased calm , conflict avoidance , self-awareness , and self-regulation for urban youths .


Importantly , based on qualitative results , the HT program functioned as an effective active control for MBSR in this sample , facilitating a more rigorous methodological approach to MBSR research in this population .


We believe the promising effects elucidated in the qualitative data have the potential for positive affective and behavioral outcomes .


Plyometric exercise has been recommended to prevent lower limb injury , but its feasibility in and effects on those with functional ankle instability ( FAI ) are unclear .


To investigate the effect of integrated plyometric and balance training in participants with FAI during a single-legged drop landing and single-legged standing position .


Randomized controlled clinical trial .


University motion-analysis laboratory .


Thirty athletes with FAI were divided into @ groups : plyometric group ( @ men , @ women , age = @ @ years ; @ unstable ankles ) , plyometric-balance ( integrated ) - training group ( @ men , @ women , age = @ @ years ; @ unstable ankles ) , and control group ( @ men , @ women , age = @ @ years ; @ unstable ankles ) .


A @-week plyometric-training program versus a @-week integrated-training program .


Postural sway during single-legged standing with eyes open and closed was measured before and after training .


Kinematic data were recorded during medial and lateral single-legged drop landings after a @-second single-legged stance .


Reduced postural sway in the medial-lateral direction and reduced sway area occurred in the plyometric - and integrated-training groups .


Generally , the plyometric training and integrated training increased the maximum angles at the hip and knee in the sagittal plane , reduced the maximum angles at the hip and ankle in the frontal and transverse planes in the lateral drop landing , and reduced the time to stabilization for knee flexion in the medial drop landing .


After @ weeks of plyometric training or integrated training , individuals with FAI used a softer landing strategy during drop landings and decreased their postural sway during the single-legged stance .


Plyometric training improved static and dynamic postural control and should be incorporated into rehabilitation programs for those with FAI .


The lack of national oral health policy and organized school dental health programs in the country call for affordable , accessible , and sustainable strategies .


The objective was to compare the oral hygiene , plaque , gingival , and dental caries status among rural children receiving dental health education by qualified dentists and school teachers with and without supply of oral hygiene aids .


This interventional study was conducted among @-year-old children selected randomly from four schools in Nalgonda district between September @ and February @ .


Schools were divided into four different intervention groups .


The intervention groups varied in the form of intervention provider and frequency of intervention one of which being the control group .


The oral hygiene , plaque , gingival , and dental caries status was assessed at baseline and @ months following the intervention .


SPSS @ was used for analysis .


The preintervention and postintervention comparison within each group revealed a substantial reduction in mean oral hygiene index-simplified ( OHI-S ) , plaque index ( PI ) , and gingival index ( GI ) at postintervention compared to baseline in group @ ( @ , @ , and @ , respectively ) followed by group @ ( @ , @ , and @ , respectively ) .


The OHI-S , PI , and GI scores increased in group @ ( @ , @ , and @ , respectively ) and group @ ( @ , @ , and @ , respectively ) .


Mean decayed , missing filled surfaces score between the groups was not statistically significant at baseline and postintervention .


The dramatic reductions in the OHI-S , PI , and GI scores in the group supplied with oral hygiene aids call for supplying low cost fluoridated toothpastes along with toothbrushes through the school systems in rural areas .


Although most mirror therapy studies have shown improved motor performance in stroke patients , the optimal mirror training protocol still remains unclear .


To study the relative contribution of a mirror in training a reaching task and of unilateral and bimanual training with a mirror .


A total of @ stroke patients at least @ months poststroke were instructed to perform a reaching task as fast and as fluently as possible .


They performed @ practice trials after being randomly allocated to @ of @ experimental groups : training with ( @ ) the paretic arm with direct view ( Paretic-No Mirror ) , ( @ ) the nonparetic arm with direct view ( Nonparetic-No Mirror ) , ( @ ) the nonparetic arm with mirror reflection ( Nonparetic Mirror ) , ( @ ) both sides and with a nontransparent screen preventing visual control of paretic side ( Bilateral-Screen ) , and ( @ ) both sides with mirror reflection of the nonparetic arm ( Bilateral-Mirror ) .


As baseline and follow-up , patients performed @ trials using only their paretic side .


Primary outcome measure was the movement time .


We found the largest intervention effect in the Paretic-No Mirror condition .


However , the Nonparetic-Mirror condition was not significantly different from the Paretic-No Mirror condition , while the Unaffected-No Mirror condition had significantly less improvement than the Paretic-No Mirror condition .


In addition , movement time improved significantly less in the bimanual conditions and there was no difference between both bimanual conditions or between both mirror conditions .


The present study confirms that using a mirror reflection can facilitate motor learning .


In this task , bimanual movement using mirror training was less effective than unilateral training .


To examine the relationships between parental patterns regarding child feeding and child body mass index ( BMI ) percentile in Latino parent-preschooler dyads participating in a clinical trial .


This secondary analysis examined data collected during a randomized clinical trial of a culturally tailored healthy lifestyle intervention focused on childhood obesity prevention , Salud Con La Familia .


We analyzed @ Latino parent-child dyads who completed baseline and @-month follow-up data collection , assessing associations between preschool child BMI percentile and parental response to the Child Feeding Questionnaire ( CFQ ) over time .


Higher child BMI was related to higher parental CFQ concern scores ( r = @ , p < @ ) .


A general inverse association between child BMI percentile and parental responsibility was also observed ( r = -@ , p = @ ) .


Over the @-month period , no statistically significant associations between changes in the CFQ subscale scores and changes in child BMI percentile were identified .


Child BMI percentile consistent with overweight/obese is associated with parental concern about child weight and child BMI percentile consistent with normal weight is associated with perceived responsibility for feeding .


Emphasizing parental responsibility to help children to develop healthy eating habits could be an important aspect of interventions aimed at both preventing and reducing pediatric obesity for Latino preschoolers .


A randomized , crossover , double-blinded placebo-controlled and non-blinded active drug-controlled , comparative clinical trial was conducted to evaluate the efficacy and safety of sublingual fentanyl tablet .


Subjects were patients treated with strong opioids at fixed intervals for chronic cancer pain and with oral morphine as rescue medication for breakthrough pain .


Sublingual fentanyl was administered at doses that were @/@th ( high dose ) and @/@th ( low dose ) of the dose of rescue morphine and was compared with placebo and oral morphine .


The primary endpoint was pain intensity difference at @ min after administration .


( Clinical Trials Government ; NCT@ ) .


Fifty-one patients were enrolled in the investigation .


Their mean pain intensity in visual analog scale before rescue medication prior to the investigation was @ ( @ , standard deviation ) mm .


Compared with placebo , the low and high doses of sublingual fentanyl showed significant analgesic effects ( least squares mean difference , @ and @ mm ; P = @ , P < @ , respectively ) .


Adverse reactions were observed in @ % , the most common being constipation , nausea and somnolence .


The incidence of adverse reactions during the high-dose administration period was higher than that during the low-dose and active control drug administration periods .


Patients treated with strong opioid analgesics at fixed intervals for chronic cancer pain and with oral morphine at doses up to @ mg as rescue medication were investigated .


The doses of sublingual fentanyl to treat breakthrough pain were determined from rescue morphine doses by use of conversion ratios .


In these patients , administration of sublingual fentanyl at doses determined by a conversion ratio of @/@ was effective and safe .


Further studies are needed to validate the use of this conversion method .


NSABP C-@ demonstrated the non-inferiority of oral adjuvant uracil and tegafur plus leucovorin ( UFT/LV ) to weekly fluorouracil and folinate ( @-FU/LV ) with respect to disease-free survival ( DFS ) for stage II/III colon cancer .


This is the first report of JCOG@ , which compared UFT/LV to standard @-FU/levofolinate ( l-LV ) for stage III colorectal cancer patients who have undergone Japanese D@/D@ lymph node dissection .


Patients were randomised to three courses of @-FU/l-LV ( @-FU @ mg/m ( @ ) , l-LV @ mg/m ( @ ) on days @ , @ , @ , @ , @ , @ every @ weeks ) or five courses of UFT/LV ( UFT @ mg m ( -@ ) day ( -@ ) , LV @ mg/day on days @-@ every @ weeks ) .


The primary end-point was DFS .


The sample size was @ determined with one-sided alpha of @ , power of @ and non-inferiority margin of hazard ratio of @ .


This trial is registered with UMIN-CTR ( C@ ) .


Between February @ and November @ , @,@ patients ( @ eligible patients ) were randomised to @-FU/l-LV ( n = @ ) or UFT/LV ( n = @ ) .


Median age : @ years , colon/rectum : @ % / @ % , number of positive nodes @ / > @ : @ % / @ % , stage IIIa/IIIb : @ % / @ % .


The hazard ratio of DFS was @ ( @ % confidence interval , @-@ @ ) , demonstrating the non-inferiority of UFT/LV ( P = @ ) .


Five-year overall survival ( @ % ) was higher than that in NSABP C-@ ( @ % ) .


Grade @/@ toxicities were @ % neutropenia in @-FU/l-LV and @ % alanine aminotransferase elevation in UFT/LV , respectively .


The incidences of diarrhoea ( @ % versus @ % ) and anorexia ( @ % versus @ % ) were similar between the two arms .


No treatment-related deaths were reported .


Adjuvant UFT/LV is non-inferior to standard @-FU/l-LV with respect to DFS .


UFT/LV should be an oral treatment option for patients with stage III colon cancer who have undergone Japanese D@/D@ lymph node dissection .


As no human data exist , we aimed to determine the relation between ambient temperature and volume of perihematomal ` cerebral ' edema in acute spontaneous intracerebral haemorrhage ( ICH ) among Chinese participants of the pilot phase , Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial ( INTERACT@ ) .


INTERACT@ was a multicenter , open , blind outcome assessed , randomized controlled trial of intensive ( systolic target < @mmHg ) vs. guideline-recommended ( systolic target < @mmHg ) blood pressure ( BP ) lowering in @ patients with acute ICH .


Data on ambient temperature ( mean , minimum , maximum , and range ) on the day of each participant 's ICH obtained from China Meteorological Data Sharing Service System were linked to other data including edema volumes .


Multivariable regression analyses were performed to evaluate association between ambient temperature and edema volumes .


A generalized linear regression model with a generalized estimating equations approach ( GEE ) was used to assess any association of ambient temperature and change in edema volume over @h .


A total of @ of all @ Chinese participants had complete data that showed positive associations between ambient temperature ( mean and minimum temperatures ) and edema volumes at each time point over @h after hospital admission ( all P < @ ) .


All temperature parameters except diurnal temperature range were positively associated with edema volume after adjustment for confounding variables ( all P < @ ) .


An apparent positive association exists between ambient temperature and perihematomal edema volume in acute spontaneous ICH .


To gain further evidence on the efficacy , safety and tolerability of tadalafil @mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil @mg ( n = @ ) or placebo ( n = @ ) for @ weeks .


A significantly greater improvement ( P < @ ) in total International Prostate Symptom Score for the change from baseline ( week @ ) to study end-point ( week @ ) was observed for tadalafil ( -@ ) versus placebo ( -@ ) .


Significantly greater improvements ( P < @ ) in total International Prostate Symptom Score for the change from baseline to weeks @ and @ were observed for tadalafil versus placebo .


Significantly greater improvements ( P < @ ) in International Prostate Symptom Score voiding and storage subscores , and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo .


Significantly greater improvements ( P < @ ) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement .


No new safety concerns were identified .


These findings confirm the efficacy and safety profile of tadalafil @mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


This was a flexible-dosed study to evaluate the efficacy and safety of duloxetine @-@mg once daily in the treatment of generalized anxiety disorder ( GAD ) in older adult patients .


Patients with GAD , who were at least @years of age , were randomly assigned to double-blind treatment with either duloxetine ( N = @ ) or placebo ( N = @ ) .


The primary efficacy measure was the Hamilton Anxiety Rating Scale ( HAM-A ) total score , and the primary endpoint was at week @ .


Global functioning was assessed by the Sheehan Disability Scale ( SDS ) .


Safety and tolerability was assessed by the occurrence of treatment-emergent adverse events , serious adverse events , laboratory analyses , and vital signs .


Analyses were conducted on an intent-to-treat basis .


The overall baseline mean HAM-A total score was @ , and SDS global score was @ .


Completion rates were @ % for placebo and @ % for duloxetine .


At week @ , duloxetine was superior to placebo on mean changes from baseline in HAM-A total scores ( -@ vs. -@ , p < @ ) and in SDS global scores ( -@ vs. -@ , p < @ ) .


Treatment-emergent adverse events occurred in @ % of duloxetine-treated patients and twice the rate than with placebo including constipation ( @ % vs. @ % , p = @ ) , dry mouth ( @ % vs. @ % , p = @ ) , and somnolence ( @ % vs. @ % , p = @ ) .


Duloxetine treatment was efficacious in the improvement of anxiety and functioning in older adult patients with GAD , and the safety profile was consistent with previous GAD studies .


Because of ongoing controversy , renal and vital outcomes are compared between systemically administered unfractionated heparin and regional anticoagulation with citrate-buffered replacement solution in predilution mode , during continuous venovenous hemofiltration ( CVVH ) in critically ill patients with acute kidney injury ( AKI ) .


In this multi-center randomized controlled trial , patients admitted to the intensive care unit requiring CVVH and meeting inclusion criteria , were randomly assigned to citrate or heparin .


Primary endpoints were mortality and renal outcome in intention-to-treat analysis .


Secondary endpoints were safety and efficacy .


Safety was defined as absence of any adverse event necessitating discontinuation of the assigned anticoagulant .


For efficacy , among other parameters , survival times of the first hemofilter were studied .


Of the @ patients enrolled , @ were randomized to citrate and @ to heparin .


Mortality rates at @ and @ days did not differ between groups : @/@ ( @ % ) of citrate-treated patients died versus @/@ ( @ % ) of heparin-treated patients at @ days , and @/@ ( @ % ) of citrate-treated patients died versus @/@ ( @ % ) of heparin-treated patients at @ days ( P = @ for both ) .


Renal outcome , i.e. independency of renal replacement therapy @ days after initiation of CVVH in surviving patients , did not differ between groups : @/@ ( @ % ) in the citrate-treated patients versus @/@ ( @ % ) in heparin-treated patients ( P = @ ) .


Heparin was discontinued in @/@ ( @ % ) of patients whereas citrate was discontinued in @/@ ( @ % ) of patients ( P < @ ) .


Filter survival times were superior for citrate ( median @ versus @ hours , P = @ ) , as were the number of filters used ( P = @ ) and the off time within @ hours ( P = @ ) .


The costs during the first @ hours of prescribed CVVH were lower in citrate-based CVVH .


Renal outcome and patient mortality were similar for citrate and heparin anticoagulation during CVVH in the critically ill patient with AKI .


However , citrate was superior in terms of safety , efficacy and costs .


The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness .


In a randomized controlled trial design , @ workers of two research institutes participated .


The intervention group ( n = @ ) received a targeted mindfulness-related training , followed by e-coaching .


The total duration of the intervention was @ months .


Data on work engagement , mental health , need for recovery and mindfulness were collected using questionnaires at baseline and after @ and @ months follow-up .


Effects were analyzed using linear mixed effect models .


There were no significant differences in work engagement , mental health , need for recovery and mindfulness between the intervention and control group after either @ - or @-months follow-up .


Additional analyses in mindfulness-related training compliance subgroups ( high and low compliance versus the control group as a reference ) and subgroups based on baseline work engagement scores showed no significant differences either .


This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness after @ and @ months .


To compare maximal evoked torque , discomfort , and fatigue-related outcomes between multipath neuromuscular electrical stimulation ( NMES ) and conventional NMES of the quadriceps muscle in patients with total knee arthroplasty ( TKA ) .


Randomized , single-blind , crossover study with @ experimental sessions ( multipath NMES , conventional NMES ) .


Research laboratory .


Patients ( N = @ ; mean age , @y ) @ to @ months after TKA surgery .


None .


We quantified NMES-evoked knee extension torque at the maximally tolerated current intensity , self-reported discomfort , and fatigue induced by NMES intermittent contractions in both conditions .


Compared with conventional NMES , multipath NMES resulted in higher evoked torque ( @ % , P < @ ) , lower discomfort scores ( -@ % , P < @ ) , and less quadriceps muscle fatigue ( P = @ ) .


The use of multiple current pathways distributed to large electrodes allowed multipath NMES to generate stronger contractions and reduce discomfort and fatigue compared with conventional NMES .


Therefore , multipath NMES has the potential to be more effective than conventional NMES .


The aim was to evaluate the impact of the ` Healthy Dads , Healthy Kids ' programme on fathers ' and mothers ' activity - and diet-related parenting practices .


Overweight/obese fathers ( n = @ ) and their primary school-aged children ( @ % boys ) were randomized to either ( i ) @-week programme ( n = @ ) or ( ii ) control group ( n = @ ) .


The programme involved four sessions for fathers only and three for fathers/children .


Mothers were not directly involved .


Parenting practices of both fathers and mothers were measured using the parenting strategies for eating and activity scale at baseline and @-week follow-up .


Intention-to-treat analysis using linear mixed models revealed significant group-by-time effects for fathers ' limit setting ( P = @ , d = @ ) and reinforcement for multiple lifestyle behaviours ( P = @ , d = @ ) .


No significant intervention effects were found for fathers ' control , monitoring , discipline or mothers ' parenting practices ( P > @ ) .


The Healthy Dads , Healthy Kids programme had a positive impact on some parenting practices for fathers but not mothers .


The Pilates method has been widely used to treat patients with chronic low back pain .


Pilates exercises can be performed in @ ways : by using specific equipment or without it ( also known as mat Pilates ) .


There are no studies , however , that have compared the effectiveness of mat Pilates with that of equipment-based Pilates .


The aim of this study was to compare the effectiveness of mat Pilates and equipment-based Pilates in patients with chronic nonspecific low back pain .


A @-arm randomized controlled trial with a blinded assessor was conducted .


The study was conducted at a private physical therapy clinic in Brazil .


Eighty-six patients with chronic nonspecific low back pain participated .


The patients were randomly allocated to @ of @ groups : a mat Pilates group ( n = @ ) and an equipment-based Pilates group ( n = @ ) .


The participants in both groups attended @ Pilates sessions over a period of @ weeks .


The primary outcomes were pain intensity and disability .


The secondary outcomes were global perceived effect , patient 's specific disability , and kinesiophobia .


A blinded assessor evaluated the outcomes at baseline and @ weeks and @ months after randomization .


After @ months , there was a statistically significant difference for disability ( mean difference = @ points , @ % confidence interval -LSB- CI -RSB- = @ to @ ) , specific disability ( mean difference = -@ points , @ % CI = -@ to -@ ) , and kinesiophobia ( mean difference = @ points , @ % CI = @ to @ ) in favor of equipment-based Pilates .


No differences were found for the remaining outcomes .


Equipment-based Pilates was superior to mat Pilates in the @-month follow-up for the outcomes of disability and kinesiophobia .


These benefits were not observed for pain intensity and global perceived effect in patients with chronic nonspecific low back pain .


To assess the effect of a weight-loss program on improving iron status in overweight and obese school-aged children .


The data were analyzed in overweight and obese children ( @-@ years of age ; @ girls and @boys ) with body mass index-for-age z-scores ( BAZ ) > @ from a weight-loss program .


Schools were randomly divided into @ groups : intervention and control .


Children in the intervention group underwent a @-year , nutrition-based comprehensive intervention weight-loss program .


Anthropometric , dietary intake , and physical activity data were collected at baseline and follow-up ( @ year ) .


Iron status and inflammatory markers were assessed within a month .


In the intervention group , BAZ decreased more than that in the control group ( -@ @ vs -@ @ , P < @ ) ; and iron profiles and inflammation status were improved at follow-up .


In multivariable linear regression models , a greater decrease of BAZ and inflammation factors predicted a better improvement of iron status .


After adjustment of BAZ , C-reactive protein was significantly associated with serum ferritin ( : @ ; @ % CI , @-@ @ ; P = @ ) and soluble transferrin receptor ( : @ ; @ % CI , @-@ @ ; P = @ ) ; interleukin-@ was significantly associated with serum ferritin ( : @ ; @ % CI , @-@ @ ; P < @ ) .


Iron status and inflammation were improved by weight reduction .


The improvement in inflammatory markers during weight reduction was independently associated with improvements of iron status .


To evaluate the efficiency and safety of two treatment regimens using ramipril or losartan in combination with hydrochlorothiazide ( HCT ) and amlodipine in grade @-@ arterial hypertension ( AH ) .


The prospective , international , multicenter , randomized , open-label , controlled trial with parallel groups included @ AH patients in Russia ( n = @ ) , Croatia , and Ukraine .


The follow-up was @ weeks in patients not receiving antihypertensive therapy ( AHT ) and @ weeks in those who had previously received AHT with regard to a washout period .


The basis for two treatment regimens was ramipril or losartan .


If no target blood pressure ( BP ) was achieved , amlodipine or HCT was added at week @ and a third antihypertensive drug ( AHD ) was used @ weeks later .


At the inclusion , clinical BP was @ / @ mm Hg in @ ( @ % ) AH patients aged @ + / - @ years .


At week @ of monotherapy with ramipil @ mg or losartan @ mg , BP was reduced to @ / @ mm Hg .


Addition of a second AHD further lowered BP to @ / @ mm Hg ( to @ / @ at @ weeks of treatment ; p < @ ) .


After @ weeks of treatment with ramipril @ mg or losartan @ mg , @ % of the patients achieved target BP .


At weeks @ and @ , double or triple AHT increased the number of patients achieving the target level up to @ and @ % , respectively .


When losartan was used as monotherapy , about one third of the patients achieved target BP ; @ and @ % of the patients required the addition of a second AHD ( HCT and amlodipine , respectively ) .


Only @ % of the patients needed to take a combination of three AHDs .


Nearly one third of the patients achieved target BP during monotherapy with losartan or ramipril .


Double AHT involving ramipril or losartan in combination with the diuretic or amlodipine was used in @ and @ % and in @ and @ % of the patients , respectively .


@ and @ % of the patients received triple therapy including ramipril or losartan , amlodipine , and HCT .


The most common adverse reactions were dizziness ( @ % ) , fatigue ( @ % ) , and coughing ( @ % ) .


In the patients with grades @-@ AH , the treatment regimens using basic therapy with ramipril or losartan proved to be highly effective and allowed target BP to be achieved in @ % of cases .


Both treatment regimens were comparable in view of safety ; slight side effects occurred rarely ( in less than @ % of the patients ) and required that the treatment should not be discontinued .


To evaluate the efficacy of diode laser ablation of prostate for treating lower urinary tract symptoms ( LUTS ) in patients with locally advanced prostate cancer and comparing results with palliative transurethral resection of prostate ( pTURP ) .


Thirty-six known cases of locally advanced prostate cancer with a maximum urinary flow rate ( Qmax ) of @ mL per second or less and an International Prostate Symptom Score ( IPSS ) of @ or more were included in this study .


Patients were randomized into two groups .


The first group underwent pTURP and for the second group diode laser ablation of prostate was done .


In @ months post-operative follow up , patients were evaluated for IPSS , post void residual ( PVR ) urine volume , Qmax and possible complications such as urethral stricture or urinary incontinence .


Postoperatively , mean IPSS was @ @ in TURP group and @ @ in laser group ( P = @ ) .


Mean PVR was @ @ mL in TURP group and @ @ mL in laser group ( P = @ ) .


Mean Qmax in TURP and laser groups were measured @ @ mL/s and @ @ mL/s , respectively ( P = @ ) .


While there was a significant improvement in IPSS and Qmax and PVR in both groups , statistical analysis did not show any significant difference postoperatively between pTURP and laser groups .


Diode laser ablation of prostate and pTURP , both improved significantly IPSS , PVR and Qmax .


But hospital stay and post-operative catheterization time was less in laser group .


Postoperative nausea and vomiting ( PONV ) occur frequently after laparoscopic bariatric surgery .


The combination of haloperidol , dexamethasone , and ondansetron may reduce these undesirable events .


The aim of this study was to evaluate the intensity of nausea and pain , the number of vomiting episodes , and morphine consumption in postoperative ( PO ) obese patients undergoing laparoscopic sleeve gastrectomy ( LSG ) .


A clinical , randomized , controlled , double-blind study conducted with @ patients with body mass index @ kg.cm-@ .


Patients were divided into three groups of @ individuals to receive ondansetron @ mg ( Group O ) ; ondansetron @ mg and dexamethasone @ mg ( Group OD ) ; and ondansetron @ mg , dexamethasone @ mg , and haloperidol @ mg ( Group HDO ) .


We evaluated the intensity of nausea and pain using the verbal numeric scale , cumulative number of vomiting episodes , and morphine consumption in the period of @-@ , @-@ , @-@ , and @-@ hours postoperatively .


Nausea intensity was lower in Group HDO compared to Group O ( p = @ ) , pain intensity was lower in Group HDO compared to Group O ( p = @ ) , and morphine consumption was lower in Group HDO compared to Group O ( p = @ ) .


There was no difference between groups regarding the number of vomiting episodes ( p = @ ) .


The combination of haloperidol , ondansetron , and dexamethasone reduced nausea and pain intensity and morphine consumption in postoperative obese patients undergoing LSG .


This study compared the biocompatibility and comfort of @ lens care solutions currently marketed in France .


This was a randomized , interventional , double-masked , single-center crossover study assessing balafilcon A silicone hydrogel contact lenses , bilaterally , straight from the blister pack solution ( control ) and pre-soaked in the following lens care solutions : Regard ( ) ( containing sodium chlorite ) , ReNu ( ) ( containing a PHMB -LSB- polyhexamethylene biguanide -RSB- derivative ) , CyClean and MeniCare Soft ( both containing PHMB ) .


Subjects were randomized to the order of test solution use .


For each of the @ solutions tested , subjects attended a baseline/lens dispensing visit and an intervention visit @h later .


At both visits , evaluation included slit-lamp examination , corrected-distance visual acuity , corneal staining , and subject-assessed photophobia , ocular comfort , and ocular redness .


Thirty subjects were enrolled and @ were evaluable .


Corneal staining severity was significantly worse than baseline after @h of wearing lenses soaked in CyClean , MeniCare , or ReNu ( P@ @ ) .


The MeniCare group alone demonstrated a significant improvement in ocular comfort after @h of lens wear ( P = @ ) .


No group demonstrated significant changes in ocular redness or photophobia .


Corrected-distance visual acuity was similar between baseline and intervention visits for each test solution .


No adverse events were reported during the study .


Silicone hydrogel contact lenses presoaked in lens solutions containing PHMB or a PHMB derivative produced an increase in corneal staining after @h of lens wear .


The higher levels of corneal staining in the @ solutions did not correlate with increased discomfort within this @-h timeframe .


The purpose of this study was to examine the relationship between fatigue and clinical outcomes , using dyspnea as a comparator , in patients with left ventricular ejection fraction ( LVEF ) @ % enrolled in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) study .


Although fatigue is a common symptom in heart failure ( HF ) , little is known about its association with prognosis .


At baseline in CORONA , fatigue `` during the past few days '' was measured using a @-point exertion scale ( @ = none , @ = heavy exertion , @ = moderate exertion , @ = slight exertion , @ = rest ) ; a @-point scale was used for dyspnea ( @ to @ as for fatigue ) .


Patients were grouped into @ categories : a fatigue score @ to @ ( n = @ ) , fatigue score @ ( n = @,@ ) , and fatigue score @ to @ ( n = @,@ ) ; and a dyspnea score of @ ( n = @ ) , dyspnea score of @ ( n = @,@ ) , and dyspnea score of @ to @ ( n = @,@ ) .


The association between fatigue and dyspnea and the composite outcome of cardiovascular ( CV ) death or HF hospital stay and each component separately was examined using Kaplan-Meier analysis and Cox proportional-hazard models .


We also examined all-cause mortality .


In univariate analyses , symptom severity was associated with a higher risk of CV death or HF hospital stay ( fatigue : group @ , @ % -LSB- n = @ -RSB- , vs. group @ , @ % -LSB- n = @ -RSB- ; dyspnea : group @ , @ % -LSB- n = @ -RSB- , vs. group @ , @ % -LSB- n = @ -RSB- ) and all-cause mortality ( fatigue : group @ , @ % -LSB- n = @ -RSB- , vs. group @ , @ % -LSB- n = @ -RSB- ; dyspnea : group @ , @ % -LSB- n = @ -RSB- , vs. group @ , @ % -LSB- n = @ -RSB- , log-rank p < @ for all ) .


After adjusting for other prognostic variables , including LVEF , New York Heart Association class , and N-terminal pro-B-type natriuretic peptide level , worse fatigue remained associated with higher risk of HF hospital stay but not mortality ( worse dyspnea remained associated with a higher risk of both ) .


An increase in fatigue ( or dyspnea ) between baseline and @ months was also associated with worse outcomes .


In HF , greater fatigue is associated with worse clinical outcomes .


Closer attention should be paid to this symptom in clinical practice , with more done to standardize its measurement and understand its origins , with a view to improving treatment .


We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy ( NACT ) .


The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT .


The immunological infiltrate was prospectively evaluated in a total of @ core biopsies from HER@ negative patients of the multicenter PREDICT study , a substudy of the neoadjuvant GeparQuinto study .


Intratumoral lymphocytes ( iTuLy ) , stromal lymphocytes ( strLy ) as well as lymphocyte-predominant breast cancer ( LPBC ) were evaluated by histopathological assessment .


Pathological complete response ( pCR ) rates were analyzed and compared between the defined subgroups using the exact test of Fisher .


Patients with lymphocyte-predominant breast cancer ( LPBC ) had a significantly increased pCR rate of @ % , compared to non-LPBC patients ( @ % , p < @ ) .


LPBC and stromal lymphocytes were significantly independent predictors for pCR in multivariate analysis ( LPBC : OR @ , p = @ , strLy : OR @ , p = @ ) .


The amount of intratumoral lymphocytes was significantly predictive for pCR in univariate ( OR @ , p = @ ) but not in multivariate logistic regression analysis ( OR @ , p = @ ) .


Confirming previous investigations of our group , we have prospectively validated in an independent cohort that an increased immunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT .


Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates .


The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies .


To formulate a comprehensive treatment program for rheumatoid arthritis arthralgia by clinical observing the efficacy of Xiaoyan Zhitong Paste ( XZP ) .


Adopted was stratified , block randomized , double-blinded , placebo parallel controlled method .


Subjects were assigned to the treatment group and the placebo group .


Those in the treatment group were treated by external application of XZP , one to two pastes each time , covering the painful area , exchange once per @ h , with one-day interval during a @-day consecutive medication , two @-days of treatment consisting of one therapeutic course .


XZP placebos were applied for those in the placebo group in the same medication way .


Joint pain and VAS were taken as main indices for observing the clinical efficacy of XZP .


The improvement of the analgesic effect and the Chinese medical syndrome efficacy of XZP were superior to that of the placebo .


XZP showed obvious effect in treating rheumatoid arthritis arthralgia with no obvious adverse reaction .


A patient-centered collaborative care program for depression and uncontrolled diabetes and/or coronary heart disease ( CHD ) demonstrated improved clinical outcomes relative to usual care .


We report clinically stratified analyses of patient outcomes to inform the duration and targeting of care management services for complex patients with multimorbidity .


A @-month randomized controlled trial of a multimorbidity collaborative care program followed patients at @ , @ , @ , and @ months for diabetes ( glycated hemoglobin -LSB- A@C -RSB- ) , blood pressure ( systolic ; SBP ) , low-density lipoprotein ( LDL ) cholesterol , and depression ( Symptoms Check List-@ score ) .


Depressed patients with less favorable medical control ( Patient Health Questionnaire-@ score > @ , A@C > @ % , SBP > @ mm Hg , and LDL cholesterol > @ mg/dL ) were compared with depressed patients with more favorable medical control to describe differential intervention benefits over time .


In contrast to patients with more favorable baseline control , patients with depression and unfavorable control of A@C , SBP , and LDL at baseline showed improved outcomes as early as the @-month follow-up assessment .


Clinical benefits in the intervention group were largely sustained over the @-month follow-up , except for some deterioration of glycemic control in intervention patients and trends toward improvement among controls over time .


Among patients with depression and more favorable medical control at baseline , there were minimal between-group differences in medical disease outcomes .


Clinical benefits of a multimorbidity collaborative care management program occurred early , and were only found among patients with poor control of baseline diabetes and CHD risk factors .


Targeting may maximize reach and improve affordability of complex care management .


Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide .


To investigate potential drug-drug interactions ( DDIs ) between lacosamide and digoxin , this phase I , multiple-dose , randomised , double-blind , placebo-controlled , crossover trial assessed the pharmacokinetics , pharmacodynamics , safety and tolerability of digoxin administered in combination with lacosamide or placebo .


Twenty healthy White male volunteers were randomised .


After receiving digoxin @ mg three times daily on day @ ( loading dose ) , participants received digoxin @ mg once daily on days @-@ .


Participants received either lacosamide ( @ mg twice daily ) or placebo on days @-@ and vice versa on days @-@ , after a @-day washout .


The steady-state area under concentration-time curve over the dosing interval ( AUC ( @ , ss ) ) and maximum steady-state plasma concentration ( C ( max , ss ) ) of digoxin were measured ; ratios of these parameters for co-administration of digoxin + lacosamide versus digoxin alone were used to evaluate potential DDIs .


Interaction was excluded if the @ % confidence interval ( CI ) for the geometric mean ratio of AUC@ , ss and C max , ss fell within the acceptance range for bioequivalence ( @-@ @ ) .


The point estimates ( @ % CI ) of the geometric mean ratios for co-administration of digoxin with lacosamide versus digoxin alone for AUC ( @ , ss ) -LSB- @ ( @-@ @ ) -RSB- and C ( max , ss ) -LSB- @ ( @-@ @ ) -RSB- were within the acceptance range for bioequivalence .


Digoxin and lacosamide co-administration was generally well-tolerated .


A small numerical increase in the mean PR interval following co-administered digoxin + lacosamide was observed versus digoxin alone and versus pre-treatment baseline values ( @ vs. @ or @ ms , respectively ) .


The RR interval increased in parallel .


The change was not considered clinically relevant .


Co-administration of steady-state digoxin ( @ mg/day ) with multiple-dose lacosamide ( @ mg/day ) versus digoxin alone revealed no differences in digoxin disposition .


Providing care for terminally ill family members places an enormous burden on informal caregivers .


Meaning in life ( MiL ) may be a protective factor , but is jeopardised in caregiving and bereavement .


This study evaluates the following questions : To what extent do bereaved informal caregivers of palliative care ( PC ) patients experience meaning in their lives ?


What differences emerge in carers compared to the general German population ?


How does MiL relate to well-being in former caregivers ?


Eighty-four bereaved PC caregivers completed the Schedule for Meaning in Life Evaluation , the Brief Symptom Inventory , the WHOQOL-BREF , a single-item numerical rating scale of quality of life , and the Satisfaction with Life Scale .


The experience of MiL of bereaved caregivers was compared to a representative population sample ( n = @ ) .


The overall MiL fulfillment of bereaved caregivers ( @ % female , age @ @ years ) was significantly lower than in the general population ( @ @ vs. @ @ , p < @ ) , as was the overall importance ascribed to their meaning framework ( @ @ vs. @ @ , p < @ ) .


PC caregivers are far more likely to list friends , leisure , nature/animals , and altruism .


Higher MiL was correlated with better life satisfaction and quality of life .


Coping with the loss of a loved one is associated with changes in MiL framework and considerably impairs a carer 's experience of MiL fulfillment .


Individual MiL is associated with well-being in PC caregivers during early bereavement .


Specific interventions for carers targeted at meaning reconstruction during palliative care and bereavement are needed to help individuals regain a sense of meaning and purpose .


To compare periodontal ligament anesthesia using a computer-controlled local anesthetic delivery system ( C-CLADS ) and submucosal infiltration anesthesia using a manually operated syringe in terms of the injection pain , anesthetic effect , anesthetic dose , and complications in healthy volunteers .


Fifty healthy volunteers , aged @ to @ years , were recruited from September @ to May @ in the Department of Stomatology of Peking Union Medical College Hospital .


A randomized self-controlled trial was conducted by applying a periodontal ligament anesthesia on one side and conventional manual submucosal infiltration anesthesia to the other ( control ) side .


The differences in the onset time of anesthesia , drug dosage , anesthetic effect , and the degree of injection pain were compared .


The complications associated with the two anesthesia methods were also recorded .


When using C-CLADS to perform a periodontal ligament anesthesia , the drug dosage and the severity of injection pain were significantly less than those of conventional manual infiltration anesthesia -LSB- drug dosage : ( @ ) ml vs. ( @ ) ml , P < @ ; VRS : @ vs. @ , P < @ ; VAS : @ vs. @ , P < @ -RSB- .


The anesthesia success rate was approximately @ % , showing no significant difference relative to conventional submucosal infiltration anesthesia .


Approximately @ % of the volunteers experienced postoperative pain after periodontal ligament anesthesia .


Compared with conventional submucosal infiltration anesthesia using manual syringes , periodontal ligament anesthesia performed using C-CLADS can reduce the injection pain and drug dosage while achieving a satisfactory anesthetic effect ; however , a considerable proportion of cases may experience postoperative pain .


Basal-cell carcinoma is the most common form of skin cancer and its incidence is increasing worldwide .


We aimed to assess the effectiveness of imiquimod cream versus surgical excision in patients with low-risk basal-cell carcinoma .


We did a multicentre , parallel-group , pragmatic , non-inferiority , randomised controlled trial at @ centres in the UK , in which patients were recruited between June @ , @ , and Feb @ , @ , with @ year follow-up from June @ , @ , to May @ , @ .


Participants of any age were eligible if they had histologically confirmed primary nodular or superficial basal-cell carcinoma at low-risk sites .


We excluded patients with morphoeic or recurrent basal-cell carcinoma and those with Gorlin syndrome .


Participants were randomly assigned ( @:@ ) via computer-generated blocked randomisation , stratified by centre and tumour type , to receive either imiquimod @ % cream once daily for @ weeks ( superficial ) or @ weeks ( nodular ) , or surgical excision with a @ mm margin .


The randomisation sequence was concealed from study investigators .


Because of the nature of the interventions , masking of participants was not possible and masking of outcome assessors was only partly possible .


The trial statistician was masked to allocation until all analyses had been done .


The primary outcome was the proportion of participants with clinical success , defined as absence of initial treatment failure or signs of recurrence at @ years from start of treatment .


We used a prespecified non-inferiority margin of a relative risk ( RR ) of @ .


Analysis was by a modified intention-to-treat population and per protocol .


This study is registered as an International Standard Randomised Controlled Trial ( ISRCTN@ ) , and with ClinicalTrials.gov , number NCT@ .


@ participants were randomly assigned to the imiquimod group ( n = @ ) or the surgical excision group ( n = @ ) .


At year @ , @ ( @ % ) patients were included in the modified intention-to-treat group .


At @ years , @ ( @ % ) of @ participants in the imiquimod group were treated successfully compared with @ ( @ % ) of @ participants in the surgery group ( RR @ , @ % CI @-@ @ ; p < @ ) .


No clear difference was noted between groups in patient-assessed cosmetic outcomes .


The most common adverse events were itching ( @ patients in the imiquimod group vs @ in the surgery group ) and weeping ( @ vs @ ) .


We recorded serious adverse events in @ ( @ % ) of @ participants in the imiquimod group and @ ( @ % ) of @ in the surgery group had serious adverse events , but none were regarded as related to treatment .


@ ( @ % ) participants in the imiquimod group withdrew because of adverse events compared with four ( @ % ) in the surgery group .


Imiquimod was inferior to surgery according to our predefined non-inferiority criterion .


Although excisional surgery remains the best treatment for low-risk basal-cell carcinoma , imiquimod cream might still be a useful treatment option for small low-risk superficial or nodular basal-cell carcinoma dependent on factors such as patient preference , size and site of the lesion , and whether the patient has more than one lesion .


Sofosbuvir ( GS-@ ) and GS-@ are nucleotide analogue HCV polymerase inhibitors , with sofosbuvir being a pyrimidine and GS-@ being a purine .


Mathematical modelling has provided important insights for characterizing HCV RNA decline and for estimating the in vivo effectiveness of single direct-acting antiviral agents ( DAAs ) ; however it has not been used to characterize viral kinetics with combination DAA therapy .


We evaluated the antiviral activity of sofosbuvir and GS-@ given alone and in combination for @ days in @ HCV genotype @ treatment-naive patients ( P@-@ ; NUCLEAR study ) .


Viral load declined rapidly in a biphasic manner in all subjects and could be well fitted by assuming that both drugs had a similar and additive level of effectiveness in reducing viral production equal to @ % , on average .


The model predicted that this level of effectiveness was not reached until @ and @ days for GS-@ and sofosbuvir , respectively , and likely represents the time needed to accumulate intracellular triphosphates .


Subsequently , both drugs led to a rapid second phase of viral decline with a mean rate of @ d ( -@ ) .


No effect of IL@B-polymorphism was found on viral kinetic parameters .


Both sofosbuvir and GS-@ are highly effective at blocking viral production from HCV-infected cells .


Both drugs led to a rapid and consistent second phase viral decline and exhibited no breakthroughs or other signs of resistance .


From a kinetics perspective , because both drugs were of the same class there was little benefit in combining them , suggesting that future DAA combinations should consider utilizing drugs with different modes of action .


To evaluate the effects of early norepinephrine ( NE ) infusion in children submitted to mechanical ventilation ( MV ) requiring continuous sedative and analgesic infusion .


Double-blinded , randomized , placebo-controlled trial enrolling children ( @ month to @ years of age ) admitted to a Brazilian PICU and expected to require MV and continuous sedative and analgesic drug infusions for at least five days .


Children were randomized to receive either norepinephrine ( NE ) ( @ mcg/kg/min ) or normal saline infusion , started in the first @ hours of MV , and maintained for @ hours .


We compared hemodynamic variables , fluid intake , renal function and urine output between groups .


Forty children were equally allocated to the NE or placebo groups , with no differences in baseline characteristics , laboratorial findings , PRISM II score , length of MV , or mortality between groups .


The average norepinephrine infusion was @ mcg/kg/min .


The NE group showed higher urine output ( p = @ ) and continuous increment in the mean arterial pressure compared to the baseline ( p = @ ) .


There were no differences in the remaining hemodynamic variables , fluid requirements , or furosemide administration .


Early norepinephrine infusion in children submitted to MV improves mean arterial pressure and increases urine output .


These effects were attributed to reversion of vasoplegia induced by the sedative and analgesic drugs .


Left atrial volume ( LAV ) is an important marker of heart failure ( HF ) severity .


We hypothesized that LAV independently correlates with clinical outcomes in patients who receive cardiac resynchronization therapy with a defibrillator ( CRT-D ) and can be used for improved risk assessment in this population .


The benefit of CRT-D versus defibrillator-only therapy in reducing the risk of HF or death was assessed by LAV ( dichotomized at the upper quartile > @ mL/m@ ) among @ patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) study .


Landmark analysis was used to evaluate the relationship between LAV response to CRT-D and subsequent clinical outcomes .


Multivariable analysis showed that patients with a higher baseline LAV experienced @ % ( P < @ ) and @ % ( P = @ ) increased hazard for HF or death and for all-cause mortality , respectively , independently of baseline left ventricular volume .


CRT-D was associated with a significant reduction in LAV compared with defibrillator-only therapy ( -@ % versus -@ % , respectively ; P < @ ) .


Landmark analysis showed that after CRT-D implantation each @ % reduction in LAV was independently associated with a corresponding @ % reduction in the hazard of subsequent HF or death ( P < @ ) .


The assessment of LAV change after CRT implantation improved prediction of clinical response to the device compared with assessment of the corresponding changes in left ventricular volume .


LAV is an independent correlate of clinical outcomes in mildly symptomatic HF patients treated with CRT-D .


CRT exerts pronounced reverse remodeling effects on the left atrium that independently correlate with improved clinical outcomes after device implantation .


Erlotinib is a drug used to treat non-small cell lung cancer , pancreatic cancer and several other types of cancer .


It is a reversible tyrosine kinase inhibitor that acts on the epidermal growth factor receptor and inhibits cell proliferation , growth , migration , invasion and survival .


This study was performed for the subsequent marketing of a test erlotinib formulation in Korea .


We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy adult volunteers .


A total of @ healthy male subjects were enrolled in a single-dose , randomized , open-label , two-period , two-sequence , crossover , bioequivalence study .


During each treatment period , subjects received @ mg of erlotinib in either the test or reference formulation .


There was a @-week washout period between each period .


Blood samples were obtained @ times during each period , before dosing and @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ and @ h after oral administration .


Plasma concentrations of erlotinib were determined using liquid chromatography-tandem mass spectrometry .


Pharmacokinetic parameters , including maximum plasma concentration ( C ( max ) ) , area under the plasma concentration-time curve to the last sampling time ( AUC ( t ) ) , AUC from time zero to infinity ( AUC ( ) ) , and time to reach C ( max ) ( t ( max ) ) , were measured , and all treatment-emergent adverse events and their relationships with the study medications were recorded throughout the study .


An additional analysis was performed to characterize the association between the cytochrome P@ ( CYP ) @A@ , CYP@A@ and CYP@A@ genotypes and the erlotinib pharmacokinetic parameters .


A total of @ subjects completed the study .


There were no significant differences in the prevalence of adverse events between the two formulations , and there were no serious or unexpected adverse events during the study .


Both formulations had very similar C ( max ) , AUC , terminal half-life ( t ) and t ( max ) values .


The @ % confidence intervals of the geometric least-squares mean ratios of the test to reference formulation were @ ( @-@ @ ) for C ( max ) and @ ( @-@ @ ) for AUCt .


Statistical significance was observed between the CYP@A@ * @M genotype and the erlotinib pharmacokinetic parameter , particularly C ( max ) ( p = @ ) .


This study suggests that the test and reference formulations of @ mg erlotinib have similar pharmacokinetic characteristics .


Both had no major safety issues and were well-tolerated .