This should ensure that kidney donors do not come to long-term harm and thereby preserve the ongoing expansion of the living donor transplant program ( NCT01769924 ) .


Chemoradiotherapy ( CHRT ) is often advocated for locally-advanced biliary tract cancer ( LABTC ) .


However there was not comparative study with chemotherapy alone ( CH ) .


Patients with hilar or extrahepatic non-metastatic , LABTC could be included in this phase II trial .


The inclusion criteria required World Health Organisation ( WHO ) performance status 2 , bilirubinemia 50 M/L after biliary drainage if necessary , and possibility of external radiotherapy .


Fluorouracil ( 5 FU ) infusion and cisplatin , were given in association to radiotherapy ( 50 Gy ) in the CHRT arm .


Gemcitabine + oxaliplatin ( GEMOX ) was planned for 6 months in the CH arm .


End-points were progression-free survival ( PFS ) , overall survival ( OS ) , toxicity and rate of biliary complications .


The trial was closed before completion due to slow recruitment .


Eighteen and 16 patients were included in the CHRT and CH arms , respectively .


Median follow up was 27.9 months ( 2.8 ) .


Grade III-IV toxicities were mostly haematological ( 23 % and 25 % ) , and gastrointestinal ( 11 % and 6 % ) , in the CHRT and CH arm , respectively .


Biliary complications occurred in 28 % of patients in the CHRT arm and 44 % of patients in the CH arm ( risk ratio ( RR ) : 1.60 [ 0.65-3 .92 ] ) .


Median PFS was 5.8 months in the CHRT group and 11.0 months in the CH group ( hazard ratio ( HR ) : 0.65 [ 0.32-1 .33 ] ) .


Median OS was 13.5 months in the CHRT group and 19.9 months in the CH group ( HR : 0.69 [ 0.31-1 .55 ] ) .


Combination of gemcitabine plus cisplatin seems to be at least as efficient as chemoradiotherapy ( 50 Gy plus 5 FU and cisplatin ) in LABTC .


Premature infants not only feel and understand the pain , but also respond more intensively compared with term infants .


Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures .


The facilitated tucking position is considered as a non-pharmacological method of pain control in infants ; however , its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied .


This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates .


This was a clinical trial study with a crossover design .


The study was conducted in a level II Neonatal Intensive Care Unit , located in a teaching hospital , affiliated to Tehran University of Medical Sciences , Tehran , Iran .


Thirty four infants were enrolled in this study based on the following inclusion criteria : age between 29 to 37 weeks of gestational age , birth weight 1200 grams or more , having an endotracheal tube , no congenital anomalies , no seizures diagnosis , no chest tubes , no intracranial hemorrhage higher than degree II , not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention .


The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking .


Preterm Infant Pain Profile ( PIPP ) was used to collect the data .


SPSS version 16.0 for Windows ( SPSS Inc. , Chicago , IL , USA ) was used for statistical analysis .


While 38.2 % of infants experienced severe pain during suctioning without intervention , only 8.8 % of them experienced severe pain during suctioning with intervention .


The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases ( p < 0.001 ) , and the mean pain score substantially reduced in cases with intervention .


Given the multiplicity of endotracheal suctioning frequency and the impossibility of frequent use of pharmacological methods of pain relief , the facilitated tucking position can be used as a safe non-pharmacological method for procedural pain management .


Moisturisers prevent and treat dry skin .


They can also protect sensitive skin , improve skin tone and texture , and mask imperfections .


Herbal medicines or their extracts have been available as topical formulations and cosmetics .


Arctium lappa L. ( Asteraceae ) has been used to treat inflammatory disorders and various skin problems .


It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract , which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics .


This study is a randomised , double-blind , placebo-controlled study with two parallel groups ( proposed herbal moisturising cream vs. placebo cream ) .


We will recruit 66 healthy male and female participants , aged 20 to 65 years , who have been diagnosed with dry skin conditions .


Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks .


Each participant will be examined for signs and symptoms before and after using the cream .


Skin hydration , sebum ( oily secretion ) levels and transepidermal water loss ( TEWL ; constitutive loss of water from the skin surface ) will be assessed .


Participants will also be asked to fill out a health-related quality of life questionnaire .


Safety will be assessed using blood tests , urine analysis , a pregnancy test , and the assessment of vital signs .


This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea .


It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief .


Moreover , we will also employ health-related quality of life questionnaires to assess changes in the quality of life .


The results of this study will be used to present the evidence needed to request advertising/display allowances , in compliance with the recently amended Cosmetics Act for advertisement in Korea .


Current Controlled Trials ISRCTN46216631 .


A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression .


Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies .


The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention .


This was a multicenter , randomized , primary prevention field trial of cardiovascular disease ( Prevencin con Dieta Mediterrnea ( PREDIMED Study ) ) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease ( 51 % of them had type 2 diabetes ; DM2 ) attending primary care centers affiliated with 11 Spanish teaching hospitals .


Primary analyses were performed on an intention-to-treat basis .


Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression .


We identified 224 new cases of depression during follow-up .


There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts ( multivariate hazard ratio ( HR ) 0.78 ; 95 % confidence interval ( CI ) 0.55 to 1.10 ) compared with participants assigned to the control group , although this was not significant .


However , when the analysis was restricted to participants with DM2 , the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance ( multivariate HR = 0.59 ; 95 % CI 0.36 to 0.98 ) .


The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2 .


This trial has been registered in the Current Controlled Trials with the number ISRCTN 35739639 .


To compare octyl-2-cyanoacrylate ( 2-OCA ) tissue adhesive with subcuticular suture for the closure of incisions in the maxillofacial region to determine 1 ) whether it is faster than traditional subcuticular suturing , 2 ) whether the number and length of incisions affect closure time , 3 ) wound morbidity , 4 ) patient satisfaction outcome , and 5 ) cosmetic outcome .


In a prospective randomized clinical trial , 29 patients were allocated to 1 of 2 groups for the closure of skin incisions using 2-OCA or conventional subcuticular skin sutures .


Postoperative follow-up evaluated wound healing at 5 to 10 days and at 3 months .


Assessment of cosmetic outcome was performed by a plastic surgeon using a modified Hollander Wound Evaluation Scale and a validated visual analog scale .


Comparisons between groups were performed using the Student t test and ( 2 ) test .


Twenty incisions in 14 patients were closed with 2-OCA and 20 incisions in 15 patients were closed with subcuticular sutures .


Mean time of closure was significantly ( P < .005 ) faster with 2-OCA at 69.50 33.39 seconds compared with 379.00 75.39 seconds in the suture group .


There was no significant difference in wound complications between the 2 groups ; also , there was no significant difference in patient satisfaction and cosmetic outcome of scars at the 3-month follow-up between the 2 groups .


2-OCA tissue adhesive is an excellent alternative to sutures for effective , reliable , and faster skin closure of maxillofacial incisions .


Keeping girls in school offers them protection against early marriage , teen pregnancy , and sexual harms , and enhances social and economic equity .


Studies report menstruation exacerbates school-drop out and poor attendance , although evidence is sparse .


This study qualitatively examines the menstrual experiences of young adolescent schoolgirls .


The study was conducted in Siaya County in rural western Kenya .


A sample of 120 girls aged 14-16 years took part in 11 focus group discussions , which were analysed thematically .


The data gathered were supplemented by information from six FGDs with parents and community members .


Emergent themes were : lack of preparation for menarche ; maturation and sexual vulnerability ; menstruation as an illness ; secrecy , fear and shame of leaking ; coping with inadequate alternatives ; paying for pads with sex ; and problems with menstrual hygiene .


Girls were unprepared and demonstrated poor reproductive knowledge , but devised practical methods to cope with menstrual difficulties , often alone .


Parental and school support of menstrual needs is limited , and information sparse or inaccurate .


Girls ' physical changes prompt boys and adults to target and brand girls as ripe for sexual activity including coercion and marriage .


Girls admitted ` others ' rather than themselves were absent from school during menstruation , due to physical symptoms or inadequate sanitary protection .


They described difficulties engaging in class , due to fear of smelling and leakage , and subsequent teasing .


Sanitary pads were valued but resource and time constraints result in prolonged use causing chafing .


Improvised alternatives , including rags and grass , were prone to leak , caused soreness , and were perceived as harmful .


Girls reported ` other girls ' but not themselves participated in transactional sex to buy pads , and received pads from boyfriends .


In the absence of parental and school support , girls cope , sometimes alone , with menarche in practical and sometimes hazardous ways .


Emotional and physical support mechanisms need to be included within a package of measures to enable adolescent girls to reach their potential .


First degree relatives ( FDRs ) of men diagnosed with prostate cancer ( PCa ) are at increased risk for developing the disease , due in part to multiple concurrent risk factors .


There is a lack of innovative targeted decision aids to help FDRs make an informed decision about whether or not to undergo PCa screening .


This randomized pilot trial evaluated the efficacy of a targeted PCa screening decision aid in unaffected FDRs of PCa survivors .


Seventy-eight Black and White FDRs were randomized to one of two decision aid groups ; 39 to a FDR-targeted decision aid and 39 to a general decision aid .


The targeted decision aid group received a general PCa decision aid booklet plus a newly developed decision aid DVD targeted specifically for FDRs .


PCa screening decision outcomes included knowledge , decisional conflict , distress , and satisfaction with screening decision .


Outcomes were assessed at baseline and 4 weeks after baseline .


There were no differences by intervention group for knowledge , decisional conflict , distress , or satisfaction with screening decision ( p > 0.05 ) .


However , men in both groups had significant increases in knowledge and decreases in decisional conflict ( p < 0.001 ) .


These changes were most pronounced ( p < 0.05 ) for younger men compared to older men .


Results suggest that general and targeted information can play an important role in increasing knowledge and decreasing decisional conflict among FDRs .


Additional research is needed to identify subgroups of men who benefit the most and better understand the outcomes of a screening decision aid among diverse samples of FDRs .


Live attenuated influenza vaccine ( LAIV ) and inactivated influenza vaccine ( IIV ) are available for children .


Local and systemic immunity induced by LAIV followed a month later by LAIV and IIV followed by LAIV were investigated with virus recovery after LAIV doses as surrogates for protection against influenza on natural exposure .


Fifteen children received IIV followed by LAIV , 13 an initial dose of LAIV , and 11 a second dose of LAIV .


The studies were done during autumn 2009 and autumn 2010 with the same seasonal vaccine ( A/California/07 / 09 [ H1N1 ] , A/Perth/16 / 09 [ H3N2 ] , B/Brisbane/60 / 08 ) .


Twenty-eight of 39 possible influenza viral strains were recovered after the initial dose of LAIV .


When LAIV followed IIV , 21 of 45 viral strains were identified .


When compared to primary LAIV infection , the decreased frequency of shedding with the IIV-LAIV schedule was significant ( P = .023 ) .


With LAIV-LAIV , the fewest viral strains were recovered ( 3/33 ) -- numbers significantly lower ( P < .001 ) than shedding after initial LAIV and after IIV-LAIV ( P < .001 ) .


Serum hemagglutination inhibition antibody responses were more frequent after IIV than LAIV ( P = .02 ) .


In contrast , more mucosal immunoglobulin A responses were seen with LAIV .


LAIV priming induces greater inhibition of virus recovery on LAIV challenge than IIV priming .


The correlate ( s ) of protection are the subject of ongoing analysis .


NCT01246999 .


Rheumatoid arthritis ( RA ) is a chronic autoimmune condition that results in pain and disability .


Patients with RA have a decreased functional ability and are forced into a sedentary lifestyle and as such , these patients often become predisposed to poor bone health .


Patients with RA may also experience a decreased health related quality of life ( HRQoL ) due to their disease .


Whole body vibration ( WBV ) is a form of exercise that stimulates bone loading through forced oscillation .


WBV has also been shown to decrease pain and fatigue in other rheumatic diseases , as well as to increase muscle strength .


This paper reports on the development of a semi randomised controlled clinical trial to assess the impact of a WBV intervention aiming to improve functional ability , attenuate bone loss , and improve habitual physical activity levels in patients with RA .


This study is a semi randomised , controlled trial consisting of a cohort of patients with established RA assigned to either a WBV group or a CON ( control ) group .


Patients in the WBV group will undergo three months of twice weekly intermittent WBV sessions , while the CON group will receive standard care and continue with normal daily activities .


All patients will be assessed at baseline , following the three month intervention , and six months post intervention .


Main outcomes will be an improvement in functional ability as assessed by the HAQ .


Secondary outcomes are attenuation of loss of bone mineral density ( BMD ) at the hip and changes in RA disease activity , HRQoL , habitual physical activity levels and body composition .


This study will provide important information regarding the effects of WBV on functional ability and BMD in patients with RA , as well as novel data regarding the potential changes in objective habitual physical activity patterns that may occur following the intervention .


The sustainability of the intervention will also be assessed .


PACTR201405000823418 ( 19/05/2014 ) .


To evaluate the impact upon medication adherence of brief telephone-based counseling using principles of motivational interviewing and telehealth home monitoring .


Randomized controlled pilot trial of 19 veterans with multiple sclerosis ( MS ) currently prescribed disease modifying therapy ( DMT ) who endorsed missing doses .


Follow-up was conducted at 1 , 3 , and 6 months .


Participants in the intervention condition reported better adherence relative to controls at 6-month follow-up [ M ( SD ) = 1.3 ( 2.1 ) vs. 8.2 ( 12.3 ) past month missed doses ] .


All participants in the intervention condition completed all 3 telephone counseling sessions and 90 % or greater rated the program as highly successful .


Brief telephone counseling represents a promising mechanism for improving medication adherence .


The primary components , motivational interviewing and home telehealth monitoring , provided complementary mechanisms for initiating and sustaining behavior change over time .


The intervention was well tolerated and provided an opportunity to extend access and reduce barriers to care by bringing it into the homes of participants .


Repeated-sprint training in hypoxia ( RSH ) was recently shown to improve repeated-sprint ability ( RSA ) in cycling .


This phenomenon is likely to reflect fiber type-dependent , compensatory vasodilation , and therefore , our hypothesis was that RSH is even more beneficial for activities involving upper body muscles , such as double poling during cross-country skiing .


In a double-blinded fashion , 17 competitive cross-country skiers performed six sessions of repeated sprints ( each consisting of four sets of five 10-s sprints , with 20-s intervals of recovery ) either in normoxia ( RSN , 300 m ; FiO2 , 20.9 % ; n = 8 ) or normobaric hypoxia ( RSH , 3000 m ; FiO2 , 13.8 % ; n = 9 ) .


Before ( pre ) and after ( post ) training , performance was evaluated with an RSA test ( 10-s all-out sprints-20-s recovery , until peak power output declined by 30 % ) and a simulated team sprint ( team sprint , 3 3-min all-out with 3-min rest ) on a double-poling ergometer .


Triceps brachii oxygenation was measured by near-infrared spectroscopy .


From pretraining to posttraining , peak power output in the RSA was increased ( P < 0.01 ) to the same extent ( 29 % 13 % vs 26 % 18 % , nonsignificant ) in RSH and in RSN whereas the number of sprints performed was enhanced in RSH ( 10.9 5.2 vs 17.1 6.8 , P < 0.01 ) but not in RSN ( 11.6 5.3 vs 11.7 4.3 , nonsignificant ) .


In addition , the amplitude in total hemoglobin variations during sprints throughout RSA rose more in RSH ( P < 0.01 ) .


Similarly , the average power output during all team sprints improved by 11 % 9 % in RSH and 15 % 7 % in RSN .


Our findings reveal greater improvement in the performance of repeated double-poling sprints , together with larger variations in the perfusion of upper body muscles in RSH compared with those in RSN .


Atazanavir-associated hyperbilirubinemia can cause premature discontinuation of atazanavir and avoidance of its initial prescription .


We used genomewide genotyping and clinical data to characterize determinants of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202 .


Plasma atazanavir pharmacokinetics and indirect bilirubin concentrations were characterized in HIV-1-infected patients randomized to atazanavir/ritonavir-containing regimens .


A subset had genomewide genotype data available .


Genomewide assay data were available from 542 participants , of whom 475 also had data on estimated atazanavir clearance and relevant covariates available .


Peak bilirubin concentration and relevant covariates were available for 443 participants .


By multivariate analysis , higher peak on-treatment bilirubin levels were found to be associated with the UGT1A1 rs887829 T allele ( P = 6.410 ( -12 ) ) , higher baseline hemoglobin levels ( P = 4.910 ( -13 ) ) , higher baseline bilirubin levels ( P = 6.710 ( -12 ) ) , and slower plasma atazanavir clearance ( P = 8.610 ( -11 ) ) .


For peak bilirubin levels greater than 3.0 mg/dl , the positive predictive value of a baseline bilirubin level of 0.5 mg/dl or higher with hemoglobin concentrations of 14 g/dl or higher was 0.51 , which increased to 0.85 with rs887829 TT homozygosity .


For peak bilirubin levels of 3.0 mg/dl or lower , the positive predictive value of a baseline bilirubin level less than 0.5 mg/dl with a hemoglobin concentration less than 14 g/dl was 0.91 , which increased to 0.96 with rs887829 CC homozygosity .


No polymorphism predicted atazanavir pharmacokinetics at genomewide significance .


Atazanavir-associated hyperbilirubinemia is best predicted by considering UGT1A1 genotype , baseline bilirubin level , and baseline hemoglobin level in combination .


Use of ritonavir as a pharmacokinetic enhancer may have abrogated genetic associations with atazanavir pharmacokinetics .


Permanent joint damage is a major consequence of rheumatoid arthritis ( RA ) , the most common and destructive form of inflammatory arthritis .


In aggressive disease , joint damage can occur within 6months from symptom onset .


Early , intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs ( DMARDs ) can delay the onset and progression of joint damage .


The primary objective of the study is to investigate the value of magnetic resonance imaging ( MRI ) or radiography ( X-ray ) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA .


A double-blind , randomized controlled trial has been designed .


Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6months .


Baseline adaptive randomization will be used to allocate participants to MRI , X-ray , or sham-intervention groups on a background of standard of care .


Prognostic markers , treating physician , and baseline DMARD therapy will be used as intervention allocation parameters .


The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images , respectively .


Radiologists will score anonymized images for all patients regardless of intervention allocation .


Disease progression will be determined based on the study-specific , inter-rater smallest detectable difference .


Allocation-dependent , intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist .


Negative reports will be delivered for the sham-intervention group .


Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care .


DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective .


A sample size of 186 ( 62 per group ) patients will be required to determine a 36 % difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90 % power at a 5 % level of significance .


This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6months over 2years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression .


This trial has been registered at ClinicalTrials.gov : NCT00808496 ( registered on 12 December 2008 ) .


Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori .


We aimed to compare the effectiveness and tolerability of these two treatments in a prospective , multicentric , randomized study .


Patients with dyspeptic complaints were recruited from 15 study centers .


Presence of Helicobacter pylori was investigated by both histology and rapid urease test .


The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid ( n = 149 ) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid ( n = 130 ) treatment arm for 14 days .


Adverse events have been recorded during the treatment phase .


A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy .


Eradication rate was calculated by intention-to-treat and per-protocol analysis .


Two hundred seventy-nine patients ( 123 male , 156 female ) were eligible for randomization .


In per-protocol analysis ( n = 247 ) , Helicobacter pylori was eradicated with ranitidine bismuth citrate - and lansoprazole-based regimens in 74,6 % and 69,2 % of cases , respectively ( p > 0,05 ) .


Intention-to-treat analysis ( n = 279 ) revealed that eradication rates were 65,1 % and 63,6 % in ranitidine bismuth citrate and in lansoprazole-based regimens , respectively ( p > 0,05 ) .


Both regimes were well-tolerated , and no serious adverse event was observed during the study .


Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen , but none of the therapies could achieve the recommendable eradication rate .


Centrally acting angiotensin converting enzyme inhibitors ( CACE-Is ) are associated with reduced rates of cognitive decline in patients with dementia .


CACE-Is may also improve exercise tolerance in functionally impaired older adults with normal cognition , suggesting that CACE-Is may positively influence activities of daily living ( ADL ) in dementia .


To compare rates of decline in patients with mild to moderate Alzheimer 's disease ( AD ) receiving CACE-Is to those not currently treated with CACE-Is ( NoCACE-I ) , included in the Doxycycline and Rifampicin for Alzheimer 's Disease study ( n = 406 ) .


Patients were included if baseline and end-point ( twelve months apart ) scores were available for measures including the Standardized Alzheimer 's Disease Assessment Scale - Cognitive Subscale ; Quick Mild Cognitive Impairment screen ; Clinical Dementia Rating Scale ( CDR-SB ) , and Lawton-Brody ADL Scale .


There was a significant , 25 % difference ( median one-point ) in the 12-month rate of decline in ADL scores in patients taking CACE-Is ( n = 91 ) , compared to the NoCACE-I group ( n = 274 ) , p = 0.024 .


This remained significant after adjusting for age , gender , education , and blood pressure , p = 0.034 .


When individual CACE-Is were compared to the NoCACE-I group , a significant reduction in the rate of decline in ADLs ( median one versus four points ) , were only observed for perindopril , p = 0.01 .


The CDR-SB was also reduced ( median one-point ) for the perindopril compared to the NoCACE-I group , p = 0.04 .


This observational study suggests that CACE-Is , and potentially perindopril in particular , are associated with a reduced rate of functional decline in patients with AD , without an association with mood or behavior .


This suggests that CACE-Is may slow disease progression in AD .


Family caregivers of patients with dementia frequently experience psychological stress , depression and disturbed psychophysiological activity , with increased levels of diurnal cortisol secretion .


To compare the effects of a cognitive-behavioural group therapy ( CBT ) to a psychoeducation group programme ( EDUC ) on cortisol secretion in caregivers of patients with moderate Alzheimer 's disease ( AD ) .


Caregivers of AD outpatients were semi-randomly allocated to one of two intervention programmes ( CBT or EDUC ) consisting of eight weekly sessions .


Twenty-six participants completed the study .


Before and after intervention , salivary cortisol was collected at four different times of the day .


Effects of the interventions were evaluated with self-report psychological scales and questionnaires related to functional abilities and neuropsychiatric symptoms of the AD relative .


Only in the CBT group did salivary cortisol levels significantly decrease after intervention , with a large effect size and high achieved power .


Both groups reported a reduction of neuropsychiatric symptoms of their AD relative after intervention .


Psychoeducation for caregivers may contribute to a reduction of neuropsychiatric symptoms of AD patients while CBT additionally attenuates psychophysiological responses to stressful situations in caregivers , by reducing diurnal cortisol levels .


This may lead to a positive impact in the general health of the caregiver , eventually resulting in better care of the AD patient .


Transcranial direct current stimulation ( tDCS ) enhances treatment outcomes post-stroke .


Feasibility and tolerability of high-definition ( HD ) tDCS ( a technique that increases current focality and intensity ) for consecutive weekdays as an adjuvant to behavioral treatment in a clinical population has not been demonstrated .


To determine HD-tDCS feasibility outcomes : 1 ) ability to implement study as designed , 2 ) acceptability of repeated HD-tDCS administration to patients , and 3 ) preliminary efficacy .


Eight patients with chronic post-stroke aphasia participated in a randomized crossover trial with two arms : conventional sponge-based ( CS ) tDCS and HD-tDCS .


Computerized anomia treatment was administered for five consecutive days during each treatment arm .


Individualized modeling/targeting procedures and an 8-channel HD-tDCS device were developed .


CS-tDCS and HD-tDCS were comparable in terms of implementation , acceptability , and outcomes .


Naming accuracy and response time improved for both stimulation conditions .


Change in accuracy of trained items was numerically higher ( but not statistically significant ) for HD-tDCS compared to CS-tDCS for most patients .


Regarding feasibility , HD-tDCS treatment studies can be implemented when designed similarly to documented CS-tDCS studies .


HD-tDCS is likely to be acceptable to patients and clinicians .


Preliminary efficacy data suggest that HD-tDCS effects , using only 4 electrodes , are at least comparable to CS-tDCS .


Implementation of trial interventions is rarely assessed , despite its effects on findings .


We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes ( SAMS ) in a trial against standard care in general practice .


The intervention increased adherence , but not through the hypothesised psychological mechanism .


This study aimed to develop a reliable coding frame for tape-recorded consultations , assessing both a priori hypothesised and potential active ingredients observed during implementation , and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked .


211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded .


Practice nurses delivered standard care to all patients and motivational and action planning ( implementation intention ) techniques to intervention patients only .


The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved .


All tape-recorded consultations were coded and a random subsample double-coded .


Nurse communication , nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques .


The coding frame proved reliable .


Intervention and standard care were clearly differentiated .


Nurse protocol adherence was good ( M ( SD ) = 3.95 ( 0.91 ) ) and competence of intervention delivery moderate ( M ( SD ) = 3.15 ( 1.01 ) ) .


Nurses frequently reinforced positive beliefs about taking medication ( e.g. , 65 % for advantages ) but rarely prompted problem solving of negative beliefs ( e.g. , 21 % for barriers ) .


Patients ' action plans were virtually identical to current routines .


Nurses showed significantly less patient-centred communication with the intervention than comparison group .


It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice .


The main study results could not be explained by poor delivery of motivational and action planning components , definition of new action plans , improved problem solving or patient-centred communication .


Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines , combined with action planning .


Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects .


ISRCTN30522359 .


Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence .


Compared with a restrictive transfusion strategy , a more liberal strategy could reduce cardiac complications by lowering myocardial damage , thereby reducing future deaths from cardiovascular disease .


We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy .


In the randomised controlled FOCUS trial , adult patients aged 50 years and older , with a history of or risk factors for cardiovascular disease , and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture , were eligible for enrolment .


Patients were recruited from 47 participating hospitals in the USA and Canada , and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher , or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia .


In this study , we analysed the long-term mortality of patients assigned to the two transfusion strategies , which was a secondary outcome of the FOCUS trial .


Long-term mortality was established by linking the study participants to national death registries in the USA and Canada .


Treatment assignment was not masked , but investigators who ascertained mortality and cause of death were masked to group assignment .


Analyses were by intention to treat .


The FOCUS trial is registered with ClinicalTrials.gov , number NCT00071032 .


Between July 19 , 2004 , and Feb 28 , 2009 , 2016 patients were enrolled and randomly assigned to the two treatment groups : 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy .


The median duration of follow-up was 31 years ( IQR 24-41 years ) , during which 841 ( 42 % ) patients died .


Long-term mortality did not differ significantly between the liberal transfusion strategy ( 432 deaths ) and the restrictive transfusion strategy ( 409 deaths ) ( hazard ratio 109 [ 95 % CI 095-125 ] ; p = 021 ) .


Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors .


The underlying causes of death did not differ between the trial groups .


These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25 % or cause of death .


National Heart , Lung , and Blood Institute .


The study aimed to evaluate the effects of probiotic Lactobacillus reuteri DSM 17938 strain supplementation in patients suffering from systemic nickel allergy syndrome , in terms of modulation of faecal LAB population linked to a reduction of GI and cutaneous symptoms and to an increase of patient 's quality of life .


A preliminary double-blind randomized placebo-controlled study was planned and a culture-independent method based on denaturing gradient gel electrophoresis ( DGGE ) analysis coupled to the 16S rRNA gene sequencing was applied to investigate on the dynamics of faecal LAB communities before and during a low-Ni diet , supplemented with the probiotic strain .


Moreover , the severity and the frequency of GI and cutaneous reactions as well as patient 's clinical condition perception ( VAS scores ) were estimated by statistical analysis .


PCR-DGGE fingerprinting obtained using LAB-specific primers revealed significant shift in faecal community with an increase in biodiversity in patients supplemented with probiotic Lact.reuteri strain .


In addition , GI reactions such as symptoms related to meals and type of stools significantly improved only in patients treated with Lact.reuteri , while severity and frequency of cutaneous symptoms ( urticaria , itch and eczema ) and recurrent abdominal pain ( RAP ) as well as VAS scores statistically decreased in both groups .


Our preliminary findings suggest that probiotic Lact.reuteri could be a useful supplementation during a low-Ni diet of patients with SNAS , to increase LAB population diversity , which could contribute to restore the intestinal homoeostasis conditions .


To date , no information is available on probiotics application and on their effects , in terms of intestinal microbiota modulation , on patients suffering from SNAS .


Therefore , the identification of dominant LAB community and the study of its shift during the probiotic supplementation could enhance the knowledge of the SNAS syndrome .


The authors hypothesized that the women enrolled in the HF-ACTION ( Heart Failure-A Controlled Trial Investigating Outcomes of Exercise TraiNing ) trial and randomly assigned to exercise training ( ET ) would improve functional capacity as measured by peak oxygen uptake ( VO2 ) compared with those in the usual care group .


Furthermore , they hypothesized that the improvement in peak VO2 would correlate with prognosis .


They explored whether exercise had a differential effect on outcomes in women versus men .


There is less evidence for the benefit of ET in women with heart failure ( HF ) compared with men because of the small numbers of women studied .


HF-ACTION was a randomized trial of ET versus usual care in 2,331 patients with class II-IV HF and a left ventricular ejection fraction of 35 % .


Sex differences in the effects of randomized treatment on clinical outcomes were assessed through the use of a series of Cox proportional hazards models , controlling for covariates known to affect prognosis in HF-ACTION .


Women had lower baseline peak VO2 and 6-min walk distance than did men ( median , 13.4 vs. 14.9 ml/min/kg and 353 vs. 378 m , respectively ) .


An increase in peak VO2 at 3 months was present in women and men in the ET group ( mean SD ; median , 0.88 2.2 , 0.80 and 0.77 2.7 , 0.60 , respectively , women vs. men ; p = 0.42 ) .


Women randomly assigned to ET had a significant reduction in the primary endpoint , ( hazard ratio : 0.74 ) compared with men ( hazard ratio : 0.99 ) randomly assigned to ET , with a significant treatment-by-sex interaction ( p = 0.027 ) .


Although there is no significant difference between men and women in the effect of ET on peak VO2 change at 3 months , ET in women with HF is associated with a larger reduction in rate of the combined endpoint of all-cause mortality and hospital stay than in men .


To investigate the effectiveness of mirror therapy ( MT ) combined with bilateral arm training and graded activities to improve motor performance in the paretic upper limb after stroke .


Randomized , controlled , assessor-blinded study .


Inpatient stroke rehabilitation center of a tertiary care teaching hospital .


Patients with first-time ischemic or hemorrhagic stroke ( N = 20 ) , confined to the territory of the middle cerebral artery , occurring < 6 months before the commencement of the study .


The MT and control group participants underwent a patient-specific multidisciplinary rehabilitation program including conventional occupational therapy , physical therapy , and speech therapy for 5 d/wk , 6 h/d , over 3 weeks .


The participants in the MT group received 1 hour of MT in addition to the conventional stroke rehabilitation .


The Upper Extremity Fugl-Meyer Assessment for motor recovery , Brunnstrom stages of motor recovery for the arm and hand , Box and Block Test for gross manual hand dexterity , and modified Ashworth scale to assess the spasticity .


After 3 weeks of MT , mean change scores were significantly greater in the MT group than in the control group for the Fugl-Meyer Assessment ( P = .008 ) , Brunnstrom stages of motor recovery for the arm ( P = .003 ) and hand ( P = .003 ) , and the Box and Block Test ( P = .022 ) .


No significant difference was found between the groups for modified Ashworth scale ( P = .647 ) .


MT when combined with bilateral arm training and graded activities was effective in improving motor performance of the paretic upper limb after stroke compared with conventional therapy without MT.


To evaluate the effect of leukoreduction ( LR ) as compared to standard nonleukoreduced ( NLR ) units on cytokine concentrations in canine erythrocyte concentrates during regular storage time .


Randomized , experimental study .


University teaching hospital .


Ten random-source research dogs .


One unit of whole blood was collected from each dog and randomized to standard processing ( NLR , n = 5 ) or prestorage LR ( n = 5 ) .


All units were stored at 4C .


Samples were aseptically collected from each unit weekly for 5 weeks .


On day 35 , 1 mL of blood was collected from each unit and submitted for aerobic culture .


An ELISA assay was used to analyze the concentrations of IL-1 , IL-8 , TNF - , and IL-10 .


There were no significant effects of either group or storage time for IL-1 , IL-10 , or TNF - .


IL-8 concentration was significantly increased over the storage period in NLR units , and was significantly higher compared to LR units on days 28 and 35 .


Aerobic culture was negative on all units .


This study demonstrated a marked , storage time-dependent accumulation of IL-8 in canine erythrocyte concentrates .


Prestorage LR attenuated the accumulation of IL-8 .


This chemokine may contribute to the proinflammatory effects of transfusion of stored erythrocyte concentrates .


Research suggests that hypertonic saline ( HS ) may improve mucous flow in infants with acute bronchiolitis .


Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3 % and 5 % saline as compared with 0.9 % saline mixed with epinephrine .


To our knowledge , 7 % HS has not been previously investigated .


We conducted a prospective , double-blind , randomized controlled trial in 101 infants presenting with moderate to severe acute bronchiolitis .


Subjects received either 7 % saline or 0.9 % saline , both with epinephrine .


Our primary outcome was a change in bronchiolitis severity score ( BSS ) , obtained before and after treatment , and at the time of disposition from the emergency department ( ED ) .


Secondary outcomes measured were hospitalization rate , proportion of admitted patients discharged at 23 hours , and ED and inpatient length of stay .


At baseline , study groups were similar in demographic and clinical characteristics .


The decrease in mean BSS was not statistically significant between groups ( 2.6 vs 2.4 for HS and control groups , respectively ) .


The difference between the groups in proportion of admitted patients ( 42 % in HS versus 49 % in normal saline ) , ED or inpatient length of stay , and proportion of admitted patients discharged at 23 hours was not statistically significant .


In moderate to severe acute bronchiolitis , inhalation of 7 % HS with epinephrine does not appear to confer any clinically significant decrease in BSS when compared with 0.9 % saline with epinephrine .


Chronic hemodialysis patients experience accelerated atherosclerosis contributed to by dyslipidemia , inflammation , and an impaired antioxidant system .


Vitamin E tocotrienols possess anti-inflammatory and antioxidant properties .


However , the impact of dietary intervention with Vitamin E tocotrienols is unknown in this population .


A randomized , double-blind , placebo-controlled , parallel trial was conducted in 81 patients undergoing chronic hemodialysis .


Subjects were provided daily with capsules containing either vitamin E tocotrienol-rich fraction ( TRF ) ( 180 mg tocotrienols , 40 mg tocopherols ) or placebo ( 0.48 mg tocotrienols , 0.88 mg tocopherols ) .


Endpoints included measurements of inflammatory markers ( C-reactive protein and interleukin 6 ) , oxidative status ( total antioxidant power and malondialdehyde ) , lipid profiles ( plasma total cholesterol , triacylglycerols , and high-density lipoprotein cholesterol ) , as well as cholesteryl-ester transfer protein activity and apolipoprotein A1 .


TRF supplementation did not impact any nutritional , inflammatory , or oxidative status biomarkers over time when compared with the baseline within the group ( one-way repeated measures analysis of variance ) or when compared with the placebo group at a particular time point ( independent t-test ) .


However , the TRF supplemented group showed improvement in lipid profiles after 12 and 16 weeks of intervention when compared with placebo at the respective time points .


Normalized plasma triacylglycerols ( cf baseline ) in the TRF group were reduced by 33 mg/dL ( P = 0.032 ) and 36 mg/dL ( P = 0.072 ) after 12 and 16 weeks of intervention but no significant improvement was seen in the placebo group .


Similarly , normalized plasma high-density lipoprotein cholesterol was higher ( P < 0.05 ) in the TRF group as compared with placebo at both week 12 and week 16 .


The changes in the TRF group at week 12 and week 16 were associated with higher plasma apolipoprotein A1 concentration ( P < 0.02 ) and lower cholesteryl-ester transfer protein activity ( P < 0.001 ) .


TRF supplementation improved lipid profiles in this study of maintenance hemodialysis patients .


A multi-centered trial is warranted to confirm these observations .


There are limited data on the efficacy of early fluid resuscitation with third-generation hydroxyethyl starch ( HES 130 ) in burn injury .


Adverse effects of HES on survival and organ function have been reported .


In this randomized , controlled , double-blind trial , 48 patients with severe burn injury were assigned to receive either lactated Ringer 's solution plus 6 % HES 130/0 .4 in a ratio of 2:1 or lactated Ringer 's solution with no colloid supplement for the first 72 hours .


Primary outcome parameter was the group difference of administered total fluid from intensive care unit ( ICU ) admission up to day 3 .


Secondary outcomes included kidney and lung injury and failure , length of stay , and mortality .


Three-day totals of administered resuscitation fluid ( medians ) were 21,190 mL in the lactated Ringer 's group and 19,535 mL in the HES group ( HES : -1,213 mL ; P = 0.39 ) .


Creatinine levels from day 1 to 3 ( HES : +0.4 mol/L ; 95 % confidence interval ( CI ) -18.7 to 19.5 ; P = 0.97 ) and urinary outputs from day 1 to 3 ( HES : -58 mL ; 95 % CI -400 to 283 ; P = 0.90 ) were not different .


Six patients in each group developed acute respiratory distress syndrome ( ARDS ) ( risk ratio 0.96 ; 95 % CI 0.35 to 2.64 ; P = 0.95 ) .


Length of ICU stay ( HES vs. lactated Ringer 's : 28 vs. 24 days ; P = 0.80 ) and length of hospital stay ( 31 vs. 29 days ; P = 0.57 ) were similar .


Twenty-eight-day mortality was 4 patients in each group ( risk ratio 0.96 ; 95 % CI 0.27 to 4.45 ; P = 0.95 ) , and in-hospital mortality was 8 in the HES group vs. 5 patients in the lactated Ringer 's group ( hazard ratio 1.86 ; 95 % CI 0.56 to 6.19 ; P = 0.31 ) .


There was no evidence that early fluid resuscitation with balanced HES 130/0 .4 ( 6 % ) in addition to lactated Ringer 's solution would lead to a volume-sparing effect in severe burn injury .


Together with the findings that early renal function , incidence of ARDS , length of stay , and mortality were not negatively influenced by HES in this setting , balanced HES 130/0 .4 ( 6 % ) plus lactated Ringer 's solution could not be considered superior to lactated Ringer 's solution alone .


ClinicalTrials.gov NCT01012648 .


The purpose of this study was to investigate the efficacy and mechanism of oxaliplatin in combination with capecitabine ( XELOX ) regimen as neoadjuvant chemotherapy in the treatment of patients with advanced gastric cancer .


Eighty-five patients with advanced gastric cancer ( stage IIB and IIIC ) were randomly divided into two groups : neoadjuvant chemotherapy group ( 40 cases ) and surgery alone group ( 45 cases ) .


In the neoadjuvant chemotherapy group , patients received oral administration of Xeloda 1000 mg/m ( 2 ) twice a day on days 1-14 and intravenous infusion of oxaliplatin 130 mg/m ( 2 ) on day 1 ( XELOX regimen ) .


The regimen was repeated every 21 days .


In the surgery alone group , patients directly received radical resection of gastric cancer .


The R0 resection rate , overall survival and disease free survival ( DFS ) were observed in all cases .


The cycles and apoptosis rate of the gastric cancer cells were detected by flow cytometry .


The expression of proliferating cell nuclear antigen ( PCNA ) , p21 , p53 and survivin was detected by Western blot .


In the neoadjuvant chemotherapy group , the total effective rate was 32.5 % ( 13/40 ) , and the tumor control rate was 90 % ( 36/40 ) , with few side effects .


Compared with the surgery alone group , R0 resection rate was significantly higher in the neoadjuvant chemotherapy group ( P < 0.05 ) .


The survival analysis indicated that both the overall survival and DFS were longer in the neoadjuvant chemotherapy group in comparison with those in the surgery alone group , but no significant differences were found ( P > 0.05 ) .


In the neoadjuvant chemotherapy group , both the apoptosis rate and the ratio of cells in stage G0 and G1 were significantly higher than those in the surgery alone group ( P < 0.05 ) .


The expression of PCNA and survivin was lower in the neoadjuvant chemotherapy group , while the expression of p21 and p53 was higher .


XELOX regimen as neoadjuvant chemotherapy in the treatment of patients with advanced gastric cancer can effectively improve the R0 resection rate and prolong the survival time of the patients .


Its mechanism is probably that the neoadjuvant chemotherapy can markedly enhance apoptosis in gastric cancer cells and inhibit their proliferation .


Despite the growing prevalence of prescription opioid dependence , longitudinal studies have not examined long-term treatment response .


The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study ( POATS ) .


POATS was a multi-site clinical trial lasting up to 9 months , examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence , with participants randomized to receive or not receive additional opioid drug counseling .


A subset of participants ( N = 375 of 653 ) enrolled in a follow-up study .


Telephone interviews were administered approximately 18 , 30 , and 42 months after main-trial enrollment .


Comparison of baseline characteristics by follow-up participation suggested few differences .


At Month 42 , much improvement was seen : 31.7 % were abstinent from opioids and not on agonist therapy ; 29.4 % were receiving opioid agonist therapy , but met no symptom criteria for current opioid dependence ; 7.5 % were using illicit opioids while on agonist therapy ; and the remaining 31.4 % were using opioids without agonist therapy .


Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 ( OR = 4.56 , 95 % CI = 1.29-16 .04 , p < .05 ) .


Engagement in agonist therapy was associated with a greater likelihood of illicit-opioid abstinence .


Eight percent ( n = 27/338 ) used heroin for the first time during follow-up ; 10.1 % reported first-time injection heroin use .


Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline .


However , a subset exhibited a worsening course , by initiating heroin use and/or injection opioid use .


To identify dosimetry , clinical factors and medication intake impacting urinary symptoms after prostate radiotherapy .


Data describing clinical factors and bladder dosimetry ( reduced with principal component ( PC ) analysis ) for 754 patients treated with external beam radiotherapy accrued by TROG 03.04 RADAR prostate radiotherapy trial were available for analysis .


Urinary symptoms ( frequency , incontinence , dysuria and haematuria ) were prospectively assessed using LENT-SOMA to a median of 72months .


The endpoints assessed were prevalence ( grade 1 ) at the end of radiotherapy ( representing acute symptoms ) , at 18 - , 36 - and 54-month follow-ups ( representing late symptoms ) and peak late incidence including only grade 2 .


Impact of factors was assessed using multivariate logistic regression models with correction for over-optimism .


Baseline symptoms , non-insulin dependent diabetes mellitus , age and PC1 ( correlated to the mean dose ) impact symptoms at > 1 timepoints .


Associations at a single timepoint were found for cerebrovascular condition , ECOG status and non-steroidal anti-inflammatory drug intake .


Peak incidence analysis shows the impact of baseline , bowel and cerebrovascular condition and smoking status .


The prevalence and incidence analysis provide a complementary view for urinary symptom prediction .


Sustained impacts across time points were found for several factors while some associations were not repeated at different time points suggesting poorer or transient impact .


Medical students experience a high burden of stress and suffer elevated rates of depression , burnout , and suicide compared to the general population , yet there is no consensus on how to address student wellness .


The purpose of this study was to determine whether an abridged mindfulness based stress reduction ( MBSR ) intervention can improve measures of wellness in a randomized sample of 1st-year medical students .


Fifty-eight participants were randomized to control or 8-week MBSR intervention and then invited to participate in the study .


All participants were assessed using the Perceived Stress Scale ( PSS ) , the Resilience Scale ( RS ) , and Self-Compassion Scale ( SCS ) at 3 separate time points : baseline , at the conclusion of the study intervention ( 8 weeks ) , and at 6 months after the conclusion of the intervention .


The intervention consisted of 75 minutes of weekly class time , suggested meditation at home , and a half-day retreat in the last week .


The intervention group achieved significant increase on SCS scores both at the conclusion of the study ( 0.58 , p = .002 ) , 95 % confidence interval ( CI ) [ 0.23 , 0.92 ] , and at 6 months ( 0.56 , p = .001 ) , 95 % CI [ 0.25 , 0.87 ] .


PSS scores achieved significant reduction at the conclusion of the study ( 3.63 , p = .03 ) , 95 % CI [ 0.37 , 6.89 ] , but not at 6 months poststudy ( 2.91 , p = .08 ) , 95 % CI [ -0.37 , 6.19 ] .


The study did not demonstrate a difference in RS after the intervention , though RS was significantly correlated with both SCS and PSS .


An abridged MBSR intervention improves perceived stress and self-compassion in 1st-year medical students and may be a valuable curricular tool to enhance wellness and professional development .


Results from this randomized , placebo-controlled study of aripiprazole augmentation to antidepressant therapy ( ADT ) in Japanese patients with major depressive disorder ( MDD ) ( the Aripiprazole Depression Multicenter Efficacy [ ADMIRE ] study ) revealed that aripiprazole augmentation was superior to ADT alone and was well tolerated .


In subgroup analyses , we investigated the influence of demographic - and disease-related factors on the observed responses .


We also examined how individual symptom improvement was related to overall improvement in MDD .


Data from the ADMIRE study were analyzed .


Subgroup analyses were performed on the primary outcome measures : the mean change in the Montgomery-sberg Depression Rating Scale ( MADRS ) total score from the end of selective serotonin reuptake inhibitor ( SSRI ) / serotonin norepinephrine reuptake inhibitor ( SNRI ) treatment to the end of the randomized treatment .


Changes in the MADRS total scores were consistently greater with aripiprazole than placebo in each of the subgroups .


Efficacy was not related to sex , age , number of adequate ADT trials in the current episode , MDD diagnosis , number of depressive episodes , duration of the current episode , age at first depressive episode , time since the first depressive episode , type of SSRI/SNRI , or severity at the end of SSRI/SNRI treatment phase .


Compared to placebo , aripiprazole resulted in significant and rapid improvement on seven of the 10 MADRS items , including sadness .


These post-hoc analyses indicated that aripiprazole was effective for a variety of Japanese patients with MDD who had exhibited inadequate responses to ADT .


Additionally , we suggest that aripiprazole significantly and rapidly improved the core depressive symptoms .


Active virtual reality gaming ( AVG ) may be useful for children with developmental coordination disorder ( DCD ) to practice motor skills if their movement patterns are of good quality while engaged in AVG .


This study aimed to examine : ( 1 ) the quality of motor patterns of children with DCD participating in AVG by comparing them with children with typical development ( TD ) and ( 2 ) whether differences existed in the motor patterns utilized with 2 AVG types : Sony PlayStation 3 Move and Microsoft Xbox 360 Kinect .


This was a quasi-experimental , biomechanical laboratory-based study .


Twenty-one children with DCD , aged 10 to 12 years , and 19 age - and sex-matched children with TD played a match of table tennis on each AVG type .


Hand path , wrist angle , and elbow angle were recorded using a motion analysis system .


Linear mixed-model analyses were used to determine differences between DCD and TD groups and Move and Kinect AVG type for forehands and backhands .


Children with DCD utilized a slower hand path speed ( backhand mean difference [ MD ] = 1.20 m/s ; 95 % confidence interval [ 95 % CI ] = 0.41 , 1.98 ) ; greater wrist extension ( forehand MD = 34.3 ; 95 % CI = 22.6 , 47.0 ) ; and greater elbow flexion ( forehand MD = 22.3 ; 95 % CI = 7.4 , 37.1 ) compared with children with TD when engaged in AVG .


There also were differences in movement patterns utilized between AVG types .


Only simple kinematic measures were compared , and no data regarding movement outcome were assessed .


If a therapeutic treatment goal is to promote movement quality in children with DCD , clinical judgment is required to select the most appropriate AVG type and determine whether movement quality is adequate for unsupervised practice .


To evaluate intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion ( CRVO ) .


Randomized , double-masked , phase 3 study .


A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal aflibercept ( n = 106 ) or sham ( n = 71 ) every 4 weeks for 20 weeks .


From weeks 24 to 48 , patients were monitored every 4 weeks ; the former group received intravitreal aflibercept as needed ( PRN ) , and the sham group received sham .


From weeks 52 to 76 , patients were monitored every 8 weeks , and both groups received intravitreal aflibercept PRN .


The primary endpoint ( proportion of patients who gained 15 letters ) was at week 24 .


This study reports exploratory outcomes at week 76 .


The proportion of patients who gained 15 letters in the intravitreal aflibercept and sham groups was 60.2 % vs 22.1 % at week 24 ( patients discontinued before week 24 were considered nonresponders ; P < .0001 ) , 60.2 % vs 32.4 % at week 52 ( last observation carried forward , P < .001 ) , and 57.3 % vs 29.4 % at week 76 ( last observation carried forward ; P < .001 ) .


Mean m change from baseline central retinal thickness was -448.6 vs -169.3 at week 24 ( P < .0001 ) , -423.5 vs -219.3 at week 52 ( P < .0001 ) , and -389.4 vs -306.4 at week 76 ( P = .1122 ) .


Over 76 weeks , the most common ocular serious adverse event in the intravitreal aflibercept group was macular edema ( 3.8 % ) .


The visual and anatomic improvements seen after fixed , monthly dosing at week 24 were largely maintained when treatment intervals were extended .


Patients with macular edema following CRVO benefited from early treatment with intravitreal aflibercept .


In Crohn 's disease patients failing infliximab therapy , interventions defined by an algorithm based on infliximab and anti-infliximab antibody measurements have proven more cost-effective than intensifying the infliximab regimen .


This study investigated long-term economic outcomes at the week 20 follow-up study visit and after 1 year .


Clinical outcomes were assessed at week 20 .


Follow-up from a 12-week , single-blind , clinical trial where patients with infliximab treatment failure were randomized to infliximab intensification ( 5 mg/kg every 4 weeks ) ( n = 36 ) , or algorithm-defined interventions ( n = 33 ) .


Accumulated costs , expressed as mean costs per patient , were based on the Danish National Patient Registry .


At the scheduled week 20 follow-up study visit , response and remission rates were similar in all study subpopulations between patients treated by the algorithm or by infliximab intensification .


However , the sum of healthcare costs related to Crohn 's disease was substantially lower ( 31 % ) for patients randomized to algorithm-based interventions than infliximab intensification in the intention-to-treat population : $ 11,940 versus $ 17,236 ; p = 0.005 .


For per-protocol patients ( n = 55 ) , costs at the week 20 follow-up visit were even lower ( 49 % ) in the algorithm group : $ 8,742 versus $ 17,236 ; p = 0.002 .


Figures were similar for patients having completed the 12-week trial as per protocol ( 50 % reduction in costs ) ( n = 45 ) .


Among patients continuing the allocated study intervention throughout the entire 20-week follow-up period ( n = 29 ) , costs were reduced by 60 % in algorithm-treated patients : $ 7,056 versus $ 17,776 ; p < 0.001 .


Cost-reduction percentages remained stable throughout one year .


Economic benefit of algorithm-based interventions at infliximab failure is maintained throughout 1 year .


H19 is a paternally imprinted oncofetal gene expressed in various embryonic tissues and in 85 % of bladder tumors but suppressed in the adult healthy bladder .


BC-819 is a DNA plasmid that carries the gene for diphtheria toxin-A under regulation of the H19 promoter sequence .


We assessed the efficacy and toxicity of intravesical BC-819 instillations to prevent tumor recurrence and ablate a marker lesion in a phase 2b trial .


A total of 47 patients with recurrent , multiple nonmuscle invasive bladder tumors in whom prior intravesical therapy had failed underwent transurethral resection of all except 1 marker tumor .


Patients expressing H19 received a 6-week induction course of intravesical BC-819 .


Patients who achieved a complete response ( absent new tumors at 3 months ) were given 3 maintenance courses of 3-weekly instillations every 3 months .


All patients were evaluable for adverse effects and 39 were evaluable forefficacy .


Complete tumor ablation was achieved in 33 % of patients and in 64 % there were no new tumors at 3 months .


Median time to recurrence was 11.3 months in all cases but significantly longer ( 22.1 months ) when analyzed byresponse status at 3 months .


Adverse events were mild .


The study was limited by the small number of patients .


BC-819 prevented new tumor growth in two-thirds of the patients and ablated a third of the marker lesions .


Prolonged time to recurrence was observed in responding patients .


These results along with the good safety profile make BC-819 a potential medication for bladder cancer .


Conducting research in real life settings ( effectiveness studies ) can introduce many confounding factors .


Efficacy studies seek to control for researcher bias and data quality rather than considering how the efficacy of an intervention is changed by the contexts in which it is used .


Relatively little is known about the impact of context on educational interventions , in particular on multimedia learning .


An effectiveness study to understand implementation variance of online educational modules in surgery clerkships was conducted in six US medical schools participating in an efficacy trial of different multimedia designs .


Student and teacher experiences were captured through focus groups and one-to-one interviews with trial participants and their teachers .


Audio-recordings of these sessions were transcribed and analysed using grounded theory techniques .


Differences were identified in student and teacher perceptions of how the educational intervention had been implemented and how its uptake had been influenced by context-dependent factors : ( i ) the intervention was implemented in different ways to suit different educational contexts and this influenced how students and teachers responded to it ; ( ii ) the ways students and teachers interacted with , and behaved around , the intervention influenced its uptake ; ( iii ) the way the intervention was perceived by students and teachers influenced its uptake ; and ( iv ) the medium and design of the intervention had a directing influence on its uptake .


It was observed that each institutional context formed a complex educational ecology .


The intervention became interwoven with different educational ecologies so that it could no longer be considered a stable variable across the study .


We suggest that researchers should conduct implementation-profiling studies in advance of any intervention-based research to account for the constructing nature of educational ecologies on their interventions and in doing so to more clearly differentiate between efficacy and effectiveness studies .


In this study , we aimed to compare clinical outcomes of superior transseptal approach with the conventional left atriotomy in patients undergoing mitral valve surgery .


Between January 2010 and November 2012 , a total of 91 consecutive adult patients ( 39 males , 52 females ; mean age : 54.015.4 years ; range , 16 to 82 years ) who underwent mitral valve surgery in the Division of Cardiovascular Surgery at Kouyolu Training Hospital were included .


The patients were randomized to either superior transseptal approach ( n = 47 ) or conventional left atriotomy ( n = 44 ) .


Demographic characteristics of the patients , comorbidities , additional interventions , intraoperational data , pre - and postoperative electrophysiological study findings , and postoperative complications were recorded .


Of all patients , 86.7 % ( n = 79 ) were in New York Heart Association Class III , while 12 were in New York Heart Association Class IV .


All patients underwent annuloplasty ( 42.9 % ) or valve replacement surgery ( 57.1 % ) .


There was no significant difference in pre - and postoperative electrocardiogram findings between the groups .


Change from baseline in the cardiac rhythm was statistically significant in superior transseptal approach group alone ( P < 0.001 ) .


There was no statistically significant difference in mortality rate between the groups .


Permanent pacemaker implantation was performed in 10.6 % of the patients in superior transseptal approach group and 4.5 % in the conventional left atriotomy group .


No statistically significant difference in bleeding , total length of hospital and intensive care unit stay , the presence of low cardiac output syndrome was observed between the groups .


Our study results suggest that superior transseptal approach does not lead to serious or fatal adverse effects on sinus node function or atrial vulnerability , compared to conventional approach .


Induction of labor for postdate pregnancy using misoprostol is one of the most common interventions in pregnancy .


However , the optimal dose of misoprostol is yet to be determined with previous reports utilizing different dosages .


The main objective of this study was to compare the effectiveness and safety of 25 g versus 50 g of intravaginal misoprostol for induction of labor in nulliparous women with postdate pregnancy .


This was a prospective study in which 88 nulliparous women with postdate pregnancy were randomly selected to receive either 25 g or 50 g of misoprostol for induction of labor .


Student 's t-test and Chi-square test were used to compare proportions .


There was no significant difference between the two groups with regard to the induction-vaginal delivery interval between the two doses .


The proportion of women delivering vaginally with a single dose of misoprostol ( 11/40 vs. 23/43 , P = 0.01 ) and vomiting were significantly greater in the 50 g group .


However , there was no significant difference between both groups in terms of the need for augmentation of labor , caesarean section , tachysystole and hyperstimulation syndrome .


Intravaginal administration of 25 g of misoprostol appears to be as effective , but safer than 50 g for induction of labor in nulliparous women with postdate pregnancy .


Increased recall rates in the Dutch breast cancer screening program call for a new assessment strategy aiming to reduce unnecessary costs and anxiety .


Diagnostic work-up ( usual care ) includes multidisciplinary hospital assessment and is similar for all recalled women , regardless of the radiologist 's suspicion of breast cancer .


This is similar in many Canadian settings .


We developed a novel assessment strategy that offers women with a low suspicion of breast cancer a quick and non-invasive assessment by a screening radiologist ( intervention ) .


We compared these two strategies in a cost-effectiveness analysis based on a randomized controlled trial : multicentre randomized controlled trial ( MASS trial , Netherlands National Trial Register : NTR1480 ) .


Participants were enrolled between August 2010 and December 2012 and were randomly assigned to either the intervention or control group ( allocation ratio 2:1 ) .


Fourteen assessment centres participated in the study .


Questionnaires were used to record quality of life ( EuroQol-5D ) , health care use and costs after recall .


Our study comprised 366 women , of whom 288 were randomly assigned to the intervention group and 88 to the control group .


The mean difference in cost was 153/CAD $ 226 ( 95 % confidence interval 107-199 / CAD $ 158-294 , p < 0.001 ) .


We found no significant differences in quality of life .


The bootstrapped incremental cost-effectiveness ratios in the cost-effectiveness plane showed that the intervention was the efficient , cost-saving modality .


Our data show the benefits of tailoring diagnostic assessment to the screening radiologist 's suspicion of breast cancer .


Scenarios of implementing such a strategy in the Dutch screening or health care system are currently being discussed with various stakeholders .


Although informed consent is vital to patient-physician communication , little training is provided to surgical trainees .


We hypothesized that highlighting critical aspects of informed consent would improve resident performance .


Eighty ( out of 88 ) surgical postgraduate year 1 surgical residents were randomly assigned to one of the 2 cases ( laparoscopic cholecystectomy or ventral herniorrhaphy ) and instructed to obtain and document informed consent with a standardized patient ( SP ) followed by a didactic training session .


The residents then obtained and documented informed consent with the other case with the other SP .


SPs graded encounters ( `` Checklist '' ) ; trained raters graded notes .


Repeated measures multivariate analysis of variance ( MANOVA ) was used to determine differences between pre - and post-training and Checklist versus `` Note '' scores .


Statistically significant pre - to post differences for Note ( P < .01 ) and Checklist ( P < .01 ) along with significant differences between Note and Checklist ( P < .01 ) were noted .


Training improved surgery residents ' ability to discuss and document informed consent .


Despite this improvement , significant differences between discussion and documentation persisted .


Documentation training is a future area for improvement .


Studies show high comorbidity between anxiety disorder and depression .


Little is known regarding how anxiety symptoms affect prognosis in depression treatment , suggesting the importance of studying the impact of anxiety symptoms in the treatment of depression .


We evaluated the impact of anxiety symptoms in the remission of depressive symptoms after brief psychotherapies for depression .


This randomized clinical trial of 18-29-year-old adults included individuals who met the diagnostic criteria for depression as assessed by the Structured Clinical Interview for DSM ( SCID ) .


Depressive symptoms were assessed using the Hamilton Rating Scale for Depression ( HRSD ) ; anxiety symptoms were assessed using the Hamilton Anxiety Rating Scale ( HARS ) .


The protocols of psychotherapy used were : Cognitive Narrative Psychotherapy ( CNP ) and Cognitive Behavioral Psychotherapy ( CBP ) .


Both treatments included seven sessions .


At the end of the treatment and six-month follow-up , an evaluation was made with the HRSD and HARS .


The sample included 97 patients divided between the protocols of psychotherapy .


There was a significant , positive , moderate correlation between the severity of anxiety symptoms at baseline and the remission of depressive symptoms at post-intervention ( r = 0.38 p < 0.001 ) as well as a significant , positive , low correlation at follow up ( r = 0.20 p = 0.049 ) .


We found remission of anxiety symptoms and depressive symptoms after brief psychotherapies , and the remission persisted at follow up .


We did not evaluate the diagnosis of anxiety disorders .


The severity of anxiety symptoms did not compromise the treatment focused primarily on depressive symptoms .


Inadequate energy and micronutrient intake during childhood is a major public health problem in developing countries .


Ready-to-use supplementary food ( RUSF ) made of locally available food ingredients can improve micronutrient status and growth of children .


The objective of this study was to develop RUSF using locally available food ingredients and test their acceptability .


A checklist was prepared of food ingredients available and commonly consumed in Bangladesh that have the potential of being used for preparing RUSF .


Linear programming was used to determine possible combinations of ingredients and micronutrient premix .


To test the acceptability of the RUSF compared to Pushti packet ( a cereal based food-supplement ) in terms of amount taken by children , a clinical trial was conducted among 90 children aged 6-18 months in a slum of Dhaka city .


The mothers were also asked to rate the color , flavor , mouth-feel , and overall liking of the RUSF by using a 7-point Hedonic Scale ( 1 = dislike extremely , 7 = like extremely ) .


Two RUSFs were developed , one based on rice-lentil and the other on chickpea .


The total energy obtained from 50 g of rice-lentil , chickpea-based RUSF and Pushti packet were 264 , 267 and 188 kcal respectively .


Children were offered 50 g of RUSF and they consumed ( meanSD ) 23.814 g rice-lentil RUSF , 28.415 g chickpea based RUSF .


Pushti packet was also offered 50 g but mothers were allowed to add water , and children consumed 17.114 g. Mean feeding time for two RUSFs and Pushti packet was 20.9 minutes .


Although the two RUSFs did not differ in the amount consumed , there was a significant difference in consumption between chickpea-based RUSF and Pushti packet ( p = 0.012 ) .


Using the Hedonic Scale the two RUSFs were more liked by mothers compared to Pushti packet .


Recipes of RUSF were developed using locally available food ingredients .


The study results suggest that rice-lentil and chickpea-based RUSF are well accepted by children .


ClinicalTrials.gov NCT01553877 .


Registered 24 January 2012 .


To compare the clinical and microbiological outcome of the 1-h ultrasonic debridement of chronic periodontitis patients ( CPP ) with and without frequent sessions of oral hygiene reinforcement .


Clinical measurements and subgingival plaque were collected from 44 CPP at baseline , 3 - and 6-months .


The control group received a single session of 1-h full-mouth ultrasonic debridement , while oral hygiene instructions ( OHI ) were reiterated over four visits .


In the test group , OHI were limited in the 1-h treatment session .


At 3-months , both groups received additional debridement and OHI .


The `` Checkerboard '' DNA-DNA hybridization technique quantified Porphyromonas gingivalis , Tannerella forsythia and Treponema denticola in plaque .


At threemonths , smaller reductions in plaque and bleeding indices , and in P. gingivalis numbers were noted in the test group , while these differences disappeared at sixmonths .


After the 3-month re-treatment visit , the test group presented with a greater probing pocket depth ( PPD ) reduction .


Plaque negatively affected PPD in a similar manner after both treatment approaches .


Lack of oral hygiene reinforcement in the 1-h full-mouth debridement resulted in higher plaque and bleeding scores and numbers of P. gingivalis at threemonths ; professional removal of dental biofilm every threemonths is beneficial in subjects with compromised plaque control .


Initiating and maintaining physical activity presents the individual with challenges of inconvenience , discomfort , and counteractive energy .


Addressing these challenges requires an intervention that elicits motivation to engage in this activity , minimizes the direct relationship between unwanted internal experiences and inaction , and is also in itself accessible and convenient .


Accordingly , this study investigated the efficacy of a self-managed Acceptance and Commitment Therapy ( ACT ) intervention delivered via DVD and tailored for physical activity initiation .


Fifty-nine minimally active community participants were randomly allocated to receive a 12-week pedometer-based walking programme , or the same walking programme with the additional provision of the ACT DVD .


The primary outcome was overall physical activity level ( assessed at baseline and post-intervention ) , and the secondary outcome was pedometer-assessed step count ( measured at 4-weekly intervals throughout the intervention period ) .


Participants who received the ACT DVD achieved a significantly greater increase in physical activity levels post-intervention , were more likely to achieve the goals specified in the programme , and reported a higher average step count than participants who received the walking programme in isolation .


The ACT intervention , delivered via DVD for the promotion of physical activity , proved a simple , efficient , and accessible method to encourage positive short-term increases in an important health-promoting behaviour .


Statement of contribution What is already known ?


ACT interventions can increase physical activity levels through augmenting initiatory self-regulatory control .


Face-to-face delivery presents challenges of accessibility and feasibility for community implementation .


There is a need for effective interventions that maximize impact while minimizing inconvenience .


What does this study add ?


Supplementing a walking programme with a self-managed ACT DVD produced significant increases in physical activity .


The ACT DVD is a convenient , accessible , and potentially cost-effective approach to physical activity initiation .


ACT lends itself to implementation as a self-managed electronically delivered intervention .


The biocompatibility of dialyzers may influence the inflammatory state of hemodialysis patients .


This study compares the effect of a high-flux polynephron membrane with other high-flux membranes , helixone and polyamide , on some inflammation biomarkers based on the analysis of circulating mononuclear cells ( MC ) .


The study included 47 patients on hemodialysis with helixone and polyamide ; 9 formed the control group , without changes in their dialyzers throughout the study , and 38 formed the intervention group , in which their dialyzers were replaced by polynephron .


In both groups , blood samples were taken at the beginning of the study before and after hemodialysis session , and at the end of the study 4 months later .


In each extraction , biochemical parameters were determined , and MC isolated using Ficoll gradient .


Production of reactive oxygen species and the percentage of activated MC ( CD14 + CD16 + ) were measured by flow cytometry , and protein levels of heat-shock proteins ( Hsp70/Hsp90 ) studied by Western blot .


After 1 hemodialysis session with different membranes , no significant differences were observed in the different parameters considered .


After 4 months of dialysis with polynephron , a significant reduction in the percentage of CD14 + CD16 + and in the 2-microglobulin reduction ratio were found , with respect to helixone and polyamide , without changes in the other parameters analyzed .


The use of polynephron for 4 months reduces the percentage of CD14 + CD16 + compared to helixone and polyamide , suggesting a better profile regarding activation of the inflammatory response .


These findings could be explained by a better biocompatibility or an increased reduction of medium-sized toxic molecules .


Injuries at home are a major cause of death , disability , and loss of quality of life among young children .


Despite current safety education , required safety behavior of parents is often lacking .


To prevent various childhood disorders , the application of Web-based tools has increased the effectiveness of health promotion efforts .


Therefore , an intervention with Web-based , tailored , safety advice combined with personal counseling ( E-Health4Uth home safety ) was developed and applied .


To evaluate the effect of E-Health4Uth home safety on parents ' safety behaviors with regard to the prevention of falls , poisoning , drowning , and burns .


A randomized controlled trial was conducted ( 2009-2011 ) among parents visiting well-baby clinics in the Netherlands .


Parents were randomly assigned to the intervention group ( E-Health4Uth home safety intervention ) or to the control condition consisting of usual care .


Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire ; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit ( age approximately 11 months ) .


Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit .


Parents ' child safety behaviors were derived from self-report questionnaires at baseline ( age 7 months ) and at follow-up ( age 17 months ) .


Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated .


Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up .


A total of 1292 parents ( response rate 44.79 % ) were analyzed .


At follow-up , parents in the intervention condition ( n = 643 ) showed significantly less unsafe behavior compared to parents in the control condition ( n = 649 ) : top of staircase ( 23.91 % vs. 32.19 % ; OR 0.65 , 95 % CI 0.50-0 .85 ) ; bottom of staircase ( 63.53 % vs. 71.94 % ; OR 0.69 , 95 % CI 0.53-0 .88 ) ; top and bottom of staircase ( 68.94 % vs. 78.28 % ; OR 0.62 , 95 % CI 0.48-0 .81 ) ; storage of cleaning products ( 30.33 % vs. 39.91 % ; OR 0.67 , 95 % CI 0.53-0 .85 ) ; bathing of the child ( 23.46 % vs. 32.25 % ; OR 0.65 , 95 % CI 0.51-0 .84 ) ; drinking hot fluids ( 34.84 % vs. 41.73 % ; OR 0.76 , 95 % CI 0.61-0 .96 ) ; using rear hotplates ( 79.34 % vs. 85.27 % ; OR 0.67 , 95 % CI 0.50-0 .90 ) ; and the total risk score in which a higher score indicates more unsafe behavior ( mean 13.63 , SD 6.12 vs. mean 15.34 , SD 6.07 ; beta -1.59 , 95 % CI -2.26 to -0.93 ) .


There were no significant differences for other specific behaviors between the two study conditions .


Compared to generic written materials , the E-Health4Uth home safety intervention seems more effective in promoting parents ' safety behavior for safe staircases , storage of cleaning products , bathing , drinking hot fluids , and cooking .


This study supports the application of Web-based , tailored , safety advice for the prevention of unintentional injuries in the youth health care setting .


Nederlands Trial Register : NTR1836 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 ( Archived by WebCite at http://www.webcitation.org/6MPIGQxpx ) .


The main objective of this study was to compare the effect of two anaesthetic techniques ( general vs combined ) on plasma levels of NGAL ( Neutrophil Gelatinase Associated Lipocalin ) after robotic urogenital oncosurgery .


The secondary objective was to correlate NGAL levels with the incidence of acute kidney injury ( AKI ) .


This was a longitudinal prospective study .


Forty patients were included and randomized in 2 groups : group C ( N = 16 cases ; combined general-epidural anesthesia ) and group G ( N = 24 cases ; control group with general anesthesia ) .


Demographic data , Charlson Comorbidity Index , Apache II , SOFA and ASA scores were similar in both groups .


Serum creatinine was determined preoperatively and every 24 hrs for 4 postoperative days to identify AKI according to RIFLE and AKIN criteria .


Serum NGAL was determined at 6 and 12 hrs after induction of anesthesia .


Serum creatinine increased at 24 hrs postoperatively in both groups as compared to baseline , but significant changes were registered only in the G group ( p ( control ) = 0.004 ) .


Serum NGAL increased significantly in both groups as compared with baseline levels ( pcase = 0.0034 vs p ( control ) = 0.0001 ) .


The incidence of AKI was 12.50 % ( 95 % CI 0.4-34 ) in the C group and 37.50 % ( 95 % CI 17-58 ) in the G group ( p = 0.0909 ) , respectively .


Impaired renal function and AKI occurred in robot-assisted laparoscopic urogenital oncosurgery under both general and combined anaesthesia .


The incidence of AKI was lower in patients undergoing combined anesthesia compared to general anaesthesia after robotic urogenital oncosurgery but the difference did not reach statistical significance .


However , plasma levels of NGAL were significantly increased at 6 and 12 hrs in the general anaesthesia group as compared with combined anaesthesia .


NGAL may be a better marker in detecting postoperative acute kidney injury .


Further studies are needed .


Concerns about pain medications are major barriers to pain management in hospice , but few studies have focused on systematic methods to address these concerns .


The objective of this study was to test the preliminary efficacy of the Effective Management of Pain : Overcoming Worries to Enable Relief ( EMPOWER ) intervention , which included hospice staff education , staff screening of barriers to pain management at admission , and discussion about misunderstandings regarding pain management with family caregivers and patients .


We conducted a pilot , cluster randomized , controlled trial with four hospices .


One hundred twenty-six family caregivers ( 55 interventions and 71 controls ) were interviewed at two weeks after admission .


If patients survived three months after admission , caregivers were reinterviewed .


At two weeks , caregivers in the intervention group reported better knowledge about pain management ( P = 0.001 ) , fewer concerns about pain and pain medications ( P = 0.008 ) , and lower patient pain over the past week ( P = 0.014 ) and trended toward improvement in most other areas under study .


Exploratory analyses suggest that EMPOWER had a greater effect for black subjects ( vs. whites ) on reducing concern about stigma .


At three months , the intervention group trended better on most study outcomes .


EMPOWER is a promising model to reduce barriers to pain management in hospice .


To study the clinical efficacy of adjuvant therapy with glucocorticoids in children with lobar pneumonia caused by Mycoplasma pneumoniae .


One hundred and eight children with lobar pneumonia caused by Mycoplasma pneumoniae were randomly divided into routine treatment and hormone treatment groups .


Both groups were treated with azithromycin and other symptomatic therapies .


In addition to the basic treatment , the hormone treatment group was given dexamethasone 0.25-0 .3 mg / ( kgd ) by intravenous drip until the body temperature was normal .


Then given oral prednisone tablets 0.5-1 mg / ( kgd ) ( gradually reduced ) for a total treatment course of 7-10 days .


Before and after treatment pulmonary functions were examined , and serum C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , interleukin-2 ( IL-2 ) and interleukin-6 ( IL-6 ) were measured .


The duration of fever , cough relief time and pulmonary shadow absorption time on chest X-ray were significantly shorter in the hormone treatment group than in the routine treatment group ( P < 0.05 ) .


After treatment , the two groups showed improvements in serum CRP , ESR , IL-2 , and IL-6 ( P < 0.05 ) , but the hormone treatment group showed significantly more improvement ( P < 0.05 ) .


Varying degrees of mixed ventilation dysfunction were seen in the two groups before treatment , and hormone therapy significantly improved pulmonary function , especially promoting the recovery of small airway function .


Adjuvant therapy with glucocorticoids can effectively alleviate clinical symptoms , promote the absorption of pulmonary inflammation , and improve pulmonary function in children with lobar pneumonia caused by Mycoplasma pneumoniae .


We sought to identify risk factors for mechanical ventilation in patients with malignancies and acute respiratory failure ( ARF ) .


We analyzed data from a previous randomized controlled trial in which nonintubated oncology and hematology subjects with ARF were randomized to early bronchoalveolar lavage or routine care in 16 ICUs in France .


Consecutive patients with malignancies were admitted to the ICU for ARF in 2005 and 2006 with no intervention .


During the study period , 219 patients were admitted to the ICU for ARF , and 8 patients were not included due to a nonintubation order .


Data on the underlying disease , pulmonary involvement , and extrapulmonary organ dysfunctions were recorded at admission in the 211 remaining subjects .


Ventilatory support included oxygen only ( 49 subjects ) , noninvasive ventilation ( NIV ) only ( 81 subjects ) , NIV followed by invasive mechanical ventilation ( 49 subjects ) , and first-line invasive mechanical ventilation ( 32 subjects ) .


The 81 subjects who required invasive mechanical ventilation were compared with the 130 subjects who remained on oxygen or NIV .


Factors associated with invasive mechanical ventilation by multivariate analysis were the oxygen flow required at ICU admission , the number of quadrants involved on chest x-ray , and hemodynamic dysfunction .


Mortality rates for subjects who had NIV failure were 65.3 % compared with 50 % for subjects who were first-line intubated ( P = .34 ) .


In cancer patients with ARF , hypoxemia , extent of pulmonary infiltration on chest x-ray , or hemodynamic dysfunction are risk factors for invasive mechanical ventilation .


Mortality was not significantly different between NIV failure and first-line intubation .


Vitamin D deficiency , defined by the total serum 25-hydroxyvitamin D [ 25 ( OH ) D ] level , is common and more prevalent among Blacks than whites .


Vitamin D-binding protein ( DBP ) levels vary with race and may modulate `` bioavailable '' levels of 25 ( OH ) D.


To determine the effect of DBP levels on the functional response to vitamin D.


A randomized , placebo-controlled trial of vitamin D repletion for 2 mo , which took place at an outpatient research unit .


Participants included 150 vitamin D-deficient ( 25 ( OH ) D < 20 ng/mL ) adults .


Participants were randomly assigned to receive either 50,000 IU of vitamin D3 or placebo weekly for 8 weeks .


This is a post-hoc analysis using DBP , 25 ( OH ) D , PTH , and calcium levels .


Blacks had lower total 25 ( OH ) D ( 12 vs 15 ng/mL , P < .001 ) and DBP levels ( 119 vs 234 g/mL , P < .001 ) than non-Blacks .


DBP levels were similar before and after vitamin D3 or placebo treatment ( r = 0.98 , P < .001 ) .


Baseline total 25 ( OH ) D levels were a significant determinant of baseline PTH levels ( P < .001 ) .


The change in total 25 ( OH ) D was associated with the change in PTH ( P < 0.001 ) and calcium levels ( P < .05 ) .


In contrast , DBP levels were not a determinant of baseline PTH ( P = .57 ) nor significantly related to changes in either PTH ( P = .53 ) or calcium levels ( P = .88 ) .


DBP levels are stable in Blacks and non-Blacks , and do not change with correction of vitamin D deficiency .


Even for individuals with total 25 ( OH ) D levels < 20 ng/mL , Blacks have significantly lower DBP levels than non-Blacks .


However , within this range of total 25 ( OH ) D , DBP levels do not influence the effect of vitamin D repletion on PTH or calcium levels .


Heart failure ( HF ) significantly impacts on the daily lives of patients and their carers .


In Western society HF education programs have increased patient and carer knowledge and improved health-related quality of life .


However , there is a paucity of such evidence in Asia .


For example , to date no studies have been conducted in Thailand to investigate the potential benefits of a family-based education program on the health outcomes of HF patients and carers .


This randomised controlled trial will evaluate the effectiveness of an education program on knowledge , self-care and health-related quality of life of Thai HF patients and their carers .


Assessments will be conducted at baseline , three and six months .


Participants will be assigned by independent random allocation to an intervention ( family-based education plus usual care ) or a control ( usual care ) group .


Analyses will be conducted on an intention-to-treat basis .


This trial will be the first to evaluate the effectiveness of family-based education for HF patients and carers residing in rural Thailand .


It attempts to advance understanding of family-based HF education and address the gap in service provision .


Thai Clinical Trial Registry TCTR20140506003 .


One-lung ventilation ( OLV ) can result in local and systemic inflammation .


This prospective , randomized trial was to evaluate the effect of therapeutic hypercapnia on lung injury after OLV .


Fifty patients aged 20 to 60 yr undergoing lobectomy were randomly provided with air or carbon dioxide ( partial pressure of carbon dioxide : 35 to 45 mmHg or 60 to 70 mmHg ) .


Peak pressure , plateau pressure , and lung compliance were recorded .


Bronchoalveolar lavage fluid ( BALF ) and blood samples were collected .


Adverse events were monitored .


The primary outcome was the concentration of BALF tumor necrosis factor , and the secondary outcomes were serum cytokine concentrations .


The BALF tumor necrosis factor was lower in the carbon dioxide group than in the air group ( median [ range ] , 51.1 [ 42.8 to 76.6 ] vs. 71.2 [ 44.8 to 92.7 ] ; P = 0.034 ) .


Patients in the carbon dioxide group had lower concentrations of serum and BALF interleukin ( IL ) -1 , IL-6 , and IL-8 , but higher serum concentrations of IL-10 , accompanied by reduced numbers of cells and neutrophils as well as lower concentrations of protein in the BALF .


Also , patients in the carbon dioxide group had lower peak ( mean SD , 22.2 2.9 vs. 29.8 4.6 ) and plateau pressures ( 20.5 2.4 vs. 27.1 2.9 ) , but higher dynamic compliance ( 46.6 5.8 vs. 38.9 6.5 ) .


Furthermore , patients in the carbon dioxide group had higher postoperation oxygenation index values .


Ten patients experienced slightly increased blood pressure and heart rate during OLV in the carbon dioxide group .


Under intravenous anesthesia , therapeutic hypercapnia inhibits local and systematic inflammation and improves respiratory function after OLV in lobectomy patients without severe complications .


The purpose was to explore operable lung cancer patient experiences with an exercise intervention from a longitudinal perspective according to patient motivation and patient perceived benefits and barriers of exercise .


Nineteen patients enrolled in an exercise intervention 2 weeks post-surgery participated in qualitative interviews at three time points .


A criteria sampling strategy was applied .