We investigated whether administration of @,@-dihydroxyvitamin D ( calcitriol ) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity , inflammation , and kidney injury .


We performed a double-blind , randomized , placebo-controlled , physiologic study among @ critically ill patients with severe sepsis or septic shock .


Patients were randomized to receive a single dose of calcitriol ( @ g intravenously ) versus placebo .


The primary outcome was plasma cathelicidin protein levels assessed @ hours after study drug administration .


Secondary outcomes included leukocyte cathelicidin mRNA expression , plasma cytokine levels ( IL-@ , IL-@ , tumor necrosis factor - , IL-@ , and IL-@ ) , and urinary kidney injury markers .


Patients randomized to calcitriol ( n = @ ) versus placebo ( n = @ ) had similar plasma cathelicidin protein levels at @ hours ( P = @ ) .


Calcitriol-treated patients had higher cathelicidin ( P = @ ) and IL-@ ( P = @ ) mRNA expression than placebo-treated patients @ hours after study drug administration .


Plasma cytokine levels ( IL-@ , IL-@ , tumor necrosis factor - , IL-@ , and IL-@ ) and urinary kidney injury markers were similar in calcitriol - versus placebo-treated patients ( P > @ for all comparisons ) .


Calcitriol had no effect on clinical outcomes nor were any adverse effects observed .


Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers .


Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


We report active treatment group differences on response and remission rates and changes in anxiety severity at weeks @ and @ for the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .


CAMS youth ( N = @ ; @ % @ years of age ) with DSM-IV separation , generalized , or social anxiety disorder were randomized to @ weeks of cognitive-behavioral therapy ( CBT ) , sertraline ( SRT ) , CBT+SRT ( COMB ) , or medication management/pill placebo ( PBO ) .


Responders attended @ monthly booster sessions in their assigned treatment arm ; youth in COMB and SRT continued on their medication throughout this period .


Efficacy of COMB , SRT , and CBT ( n = @ ) was assessed at @ and @ weeks postrandomization .


Youth randomized to PBO ( n = @ ) were offered active CAMS treatment if nonresponsive at week @ or over follow-up and were not included here .


Independent evaluators blind to study condition assessed anxiety severity , functioning , and treatment response .


Concomitant treatments were allowed but monitored over follow-up .


The majority ( > @ % ) of acute responders maintained positive response at both weeks @ and @ .


Consistent with acute outcomes , COMB maintained advantage over CBT and SRT , which did not differ , on dimensional outcomes ; the @ treatments did not differ on most categorical outcomes over follow-up .


Compared to COMB and CBT , youth in SRT obtained more concomitant psychosocial treatments , whereas those in SRT and CBT obtained more concomitant combined ( medication plus psychosocial ) treatment .


COMB maintained advantage over CBT and SRT on some measures over follow-up , whereas the @ monotherapies remained indistinguishable .


The observed convergence of COMB and monotherapy may be related to greater use of concomitant treatment during follow-up among youth receiving the monotherapies , although other explanations are possible .


Although outcomes were variable , most CAMS-treated youth experienced sustained treatment benefit .


Clinical trial registration information-Child and Adolescent Anxiety Disorders ( CAMS ) ; URL : http://clinicaltrials.gov .


Unique identifier : NCT@ .


The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions .


The randomized Nordic Stent Technique Study showed similar @-month clinical and @-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents .


Here , we report the @-month efficacy and safety of the Nordic Stent Technique Study .


A total of @ patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for @ months .


Major adverse cardiac events-the composite of cardiac death , myocardial infarction , stent thrombosis , ortarget vessel revascularization-were the primary endpoint .


Follow-up was complete for all patients .


At @ months , the rates of the primary endpoint were @ % versus @ % ( p = @ ) , index lesion restenosis @ % versus @ % ( p = @ ) , and definitestent thrombosis @ % versus @ % ( p = @ ) in the crush and the culotte groups , respectively .


At @-month follow-up , the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique .


( Nordic Bifurcation Study .


How to Use Drug Eluting Stents -LSB- DES -RSB- in Bifurcation Lesions ?


NCT@ ) .


The incidence of chronic pain is higher among immigrants in Europe than among the native European population .


Therapeutic interventions in this population are far less effective than in patients for whom these programmes were originally developed .


In a randomised trial , we investigated whether a cognitive behavioural treatment ( CBT ) programme supplemented with culturally sensitive aspects ( CsCBT ) improves pain intensity , pain disability and quality of life among immigrant patients , compared with a treatment of culturally sensitive exercise therapy ( CsET ) alone .


Furthermore , we investigated whether healthcare costs would decrease .


First-generation Turkish immigrants residing in Switzerland ( @-@ years of age ) who suffered from chronic pain were enrolled in the trial .


Patients were randomised to attend either CsCBT or CsET .


The CsCBT intervention was based upon a manualised cognitive-behavioural group treatment programme for chronic pain patients and adapted to the needs of a Turkish immigrant population .


The CsET intervention was based on principles of exercise therapy for treatment of nonspecific low back pain .


A total of @ outpatients were recruited between October @ and November @ .


The intervention was completed by @ patients ( @ % ) .


A total of @ subjects ( @ % ) completed follow-up , @ months after the completion of the intervention programme .


The intervention showed no effects in reducing pain , pain disability or quality of life .


The analysis of healthcare utilisation yielded no intervention effect .


Cognitive behavioural intervention is feasible with immigrants with chronic disabling pain , but the evidence-based CBT programme , as well as exercise therapy supplemented with culturally sensitive aspects , showed no improvement .


The objectives of this randomized , single-blinded , placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population .


Twenty-one patients were recruited ( varenicline = @ , placebo = @ ) , and @ patients in the varenicline and @ in the placebo group completed the study .


Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale , and varenicline-related adverse effects were assessed .


Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo .


Varenicline was well-tolerated in this population , with no adverse drug effects ( including nausea ) observed and no effect on improvements in pain severity and depression .


This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification .


Natural ultraviolet exposure induces hair damage , which is difficult to avoid .


Most of the research work is focused on the effect of ultraviolet on the epidermis , dermis as well as the immune system , whereas the long-term effect of ultraviolet on hair has not been investigated .


we performed our experiment to find out the changes induced in hair follicle and shaft in those patients exposed to high doses of ultraviolet ( A and B ) during treatment of other skin conditions .


Light and transmission electron microscopy examination of scalp hair follicles and shafts of @ patients with vitiligo under psoralen plus ultraviolet A ( group @ ) and @ patients with vitiligo under narrow band ultraviolet B ( group @ ) was carried out and compared with those of @ healthy volunteers ( group @ ) .


Physical changes in the appearance of hair were more in groups @ and @ than control .


Reduced hair follicle thickness and perifollicular infiltrate and hyaline disorganized perifollicular collagen were observed more in group @ than in group @ with the absence of these changes in group @ .


Transmission electron microscopy showed nonspecific cell injury in hair follicles in group @ more than the other @ groups , while the damaging effect on hair was more in the second group than the others .


Due to the damaging effect of ultraviolet on hair , patients under treatment with this modality should be cautious to protect their hair during treatment .


Kawasaki disease , the most common cause of acquired heart disease in developed countries , is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin .


Resistance to intravenous immunoglobulin in Kawasaki disease increases the risk of coronary artery aneurysms .


We assessed whether the addition of infliximab to standard therapy ( intravenous immunoglobulin and aspirin ) in acute Kawasaki disease reduces the rate of treatment resistance .


We undertook a phase @ , randomised , double-blind , placebo-controlled trial in two children 's hospitals in the USA to assess the addition of infliximab ( @ mg per kg ) to standard therapy .


Eligible participants were children aged @ weeks-@ years who had a fever ( temperature @C ) for @-@ days and met American Heart Association criteria for Kawasaki disease .


Participants were randomly allocated in @:@ ratio to two treatment groups : infliximab @ mg/kg at @ mg/mL intravenously over @ h or placebo ( normal saline @ mL/kg , administered intravenously ) .


Randomisation was based on a randomly permuted block design ( block sizes @ and @ ) , stratified by age , sex , and centre .


Patients , treating physicians and staff , study team members , and echocardiographers were all masked to treament assignment .


The primary outcome was the difference between the groups in treatment resistance defined as a temperature of @C or higher at @ h to @ days after completion of the infusion of intravenous immunoglobulin .


Analysis was by intention to treat .


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


@ patients were enrolled and randomised : @ to the infliximab group and @ to placebo .


One patient in the placebo group was withdrawn from the study because of hypotension before receiving treatment .


Treatment resistance rate did not differ significantly ( @ -LSB- @ % -RSB- for infliximab and @ -LSB- @ % -RSB- for placebo ; p = @ ) .


Compared with the placebo group , participants given infliximab had fewer days of fever ( median @ day for infliximab vs @ days for placebo ; p < @ ) .


At week @ , infliximab-treated patients had greater mean reductions in erythrocyte sedimentation rate ( p = @ ) and a two-fold greater decrease in Z score of the left anterior descending artery ( p = @ ) than did those in the placebo group , but this difference was not significant at week @ .


Participants in the infliximab group had a greater mean reduction in C-reactive protein concentration ( p = @ ) and in absolute neutrophil count ( p = @ ) at @ h after treatment than did those given placebo , but by week @ this difference was not significant .


At week @ , none of the laboratory values differed significantly compared with baseline .


No significant differences were recorded between the two groups at any timepoint in proximal right coronary artery Z scores , age-adjusted haemoglobin values , duration of hospital stay , or any other laboratory markers of inflammation measured .


No reactions to intravenous immunoglobulin infusion occurred in patients treated with infliximab compared with @ ( @ % ) patients given placebo ( p < @ ) .


No serious adverse events were directly attributable to infliximab infusion .


The addition of infliximab to primary treatment in acute Kawasaki disease did not reduce treatment resistance .


However , it was safe and well tolerated and reduced fever duration , some markers of inflammation , left anterior descending coronary artery Z score , and intravenous immunoglobulin reaction rates .


To analyze changes in refraction and associated biometric changes in atropine - and placebo-treated eyes in the Atropine for Treatment of Myopia study ( ATOM@ ) .


A total of @ myopic children , aged @ to @ years , were assigned randomly to receive @ % atropine or a placebo agent in one eye daily for @ years , after which drops were stopped and children monitored for another year .


Cycloplegic autorefraction , A-scan biometry , and automated keratometry were performed at the initial visit , @ weeks ( baseline ) , and at @ , @ , @ , @ , @ , @ , @ , and @ months .


A total of @ children ( @ % ) completed the study .


In placebo-treated eyes , there was myopic progression of -@ diopters ( D ) , between baseline and @ months , associated with reductions in corneal curvature ( K ; -@ D ) and anterior chamber depth ( ACD ; -@ mm ) and increases in lens thickness ( LT ; @ mm ) , vitreous chamber depth ( VCD ; @ mm ) , and axial length ( AL ; @ mm ) .


Multivariate analysis of change in spherical equivalent demonstrated that the hyperopic shift ( @ D ) noted in atropine-treated eyes between baseline and @ months , and the myopic rebound ( -@ D ) noted between @ to @ months when atropine was stopped , were associated with a reduction and increase in VCD and AL , respectively , after adjusting for age and sex .


Changes in K , ACD , and LT were less relevant .


Between @ and @ months , atropine-treated eyes demonstrated gradual myopic progression ( -@ D ) , accompanied by reduction in K ( -@ D ) and ACD ( -@ mm ) and increase in VCD ( @ mm ) and AL ( @ mm ) .


Atropine appeared to slow myopia progression mainly by reducing or slowing the growth in VCD , and thereby AL. ( ClinicalTrials.gov number , NCT@ . )


Sutezolid ( PNU-@ ) is a linezolid analog with superior bactericidal activity against Mycobacterium tuberculosis in the hollow fiber , whole blood and mouse models .


Like linezolid , it is unaffected by mutations conferring resistance to standard TB drugs .


This study of sutezolid is its first in tuberculosis patients .


Sputum smear positive tuberculosis patients were randomly assigned to sutezolid @ mg BID ( N = @ ) or @ mg QD ( N = @ ) , or standard @-drug therapy ( N = @ ) for the first @ days of treatment .


Effects on mycobacterial burden in sputum ( early bactericidal activity or EBA ) were monitored as colony counts on agar and time to positivity in automated liquid culture .


Bactericidal activity was also measured in ex vivo whole blood cultures ( whole blood bactericidal activity or WBA ) inoculated with M. tuberculosis H@Rv .


All patients completed assigned treatments and began subsequent standard TB treatment according to protocol .


The @ % confidence intervals ( CI ) for bactericidal activity in sputum over the @ day interval excluded zero for all treatments and both monitoring methods , as did those for cumulative WBA .


There were no treatment-related serious adverse events , premature discontinuations , or dose reductions due to laboratory abnormalities .


There was no effect on the QT interval .


Seven sutezolid-treated patients ( @ % ) had transient , asymptomatic ALT elevations to @ U/L on day @ that subsequently normalized promptly ; none met Hy 's criteria for serious liver injury .


The mycobactericidal activity of sutezolid @ mg BID or @ mg QD was readily detected in sputum and blood .


Both schedules were generally safe and well tolerated .


Further studies of sutezolid in tuberculosis treatment are warranted .


Several planning studies have already proven the substantial dosimetric advantages of RapidArc ( RA ) over standard intensity-modulated radiotherapy .


We retrospectively compared RapidArc and standard sliding window IMRT ( swIMRT ) in locally advanced head and neck cancer , looking both at dosimetrics as well as toxicity and outcome .


CT datasets of @ patients treated with swIMRT and @ patients treated with RA were included .


To compare the resulting dose distributions , the dose-volume parameters were evaluated for the planning target volumes ( PTVs ) , clinical target volumes ( CTVs ) , and organs at risk ( OARs ) , and the number of MU were calculated .


Acute toxicity was assessed by the Common Toxicity Criteria version @ .


PTV coverage with the @ % isodose was slightly better for RA .


Dose distribution has proven to be significantly more homogenous with RA and led to a reduction of @ % in MU with better OAR sparing .


As for toxicity , more grade @ mucositis and dysphagia was observed for swIMRT , though we observed more grade @ dermatitis for RA .


In our retrospective analysis , RA had better target coverage and better sparing of the OAR .


Overall , the grade of acute toxicity was lower for RA than for swIMRT for the same types of tumor locations , except for the grade of dermatitis .


Electrical muscle stimulation ( EMS ) is applied to critically ill patients in order to improve their muscle strength , thereby preventing hypotrophy and promoting functional recovery .


To assess the effects of early EMS on the range of movement of the ankle joint , and on thigh and leg circumference in critically ill patients .


This is a prospective randomized clinical trial comprising @ patients undergoing mechanical ventilation .


Before and after EMS the thigh and leg circumference in both lower limbs and the goniometry of the tibiotarsal joint were measured .


The angle of @ on the goniometer was taken as the standard neutral position ( NP ) , with the arm fixed on the lateral malleolus of the ankle joint .


Other measurements , namely dorsiflexion and plantar flexion , referred to as mobile arm , were taken from the NP .


These recordings were obtained following an active contraction of the patients ' muscles .


Compared with the electrostimulated limb , a difference in dorsiflexion of the control limb was observed ( @ versus @ ; p = @ ) .


A girth of @cm of the leg was found in limb reduction when compared to the electrostimulated one ( @ versus @ cm ; p = @ ) .


EMS used at low current intensity and for a short duration failed to prevent muscle atrophy in critically ill patients .


However , we did find a significant improvement in active dorsiflexion of the ankle joint suggesting that it could help to prevent against stance plantar flexion in these patients .


Despite numerous benefits of live donor kidney transplant ( LDKT ) , patient-level barriers often prevent African Americans from considering LDKT .


Educational interventions designed to address patient-level barriers may increase willingness among African American patients with end-stage renal disease to explore LDKT as a treatment option .


To assess the effectiveness of a culturally sensitive educational intervention called Living ACTS ( About Choices in Transplantation and Sharing ) that was designed to address patient-level barriers to LDKT among African American patients with end-stage renal disease .


Patients were randomized to intervention ( n = @ ) or control ( n = @ ) groups .


They completed baseline measures and then viewed either the Living ACTS or control video .


Both groups then completed an immediate follow-up measure and a @-month assessment administered via telephone .


Self-reported knowledge about LDKT , willingness to talk to the patient 's family about LDKT , and perceived benefits of LDKT were measured at @ time points .


At @-month follow-up , intervention participants demonstrated a significantly greater increase in knowledge of LDKT than control participants ( F@ ,@ = @ , P = @ ) .


Intervention participants expressed greater willingness to talk to patients ' families about LDKT than did control participants from baseline through @-month follow-up ( F@ ,@ = @ , P = @ ) .


Finally , at immediate follow-up , intervention participants reported greater endorsement of the benefits of LDKT than did control participants ( F@ ,@ = @ , P < @ ) ; however , this effect had disappeared by the @-month follow-up .


Living ACTS is effective at increasing and maintaining knowledge about LDKT among African American patients with end-stage renal disease who are considering transplant .


Discharge anticoagulation counseling is important for ensuring patient comprehension and optimizing clinical outcomes .


As pharmacy resources become increasingly limited , the impact of informational videos on the counseling process becomes more relevant .


To evaluate differences in pharmacist time spent counseling and patient comprehension ( measured by the Oral Anticoagulation Knowledge -LSB- OAK -RSB- test ) between informational videos and traditional face-to-face ( oral ) counseling .


This prospective , open , parallel-group study at an academic medical center randomized @ individuals-@ warfarin-nave ( `` New Start '' ) and @ with prior warfarin use ( `` Restart '' ) - to receive warfarin discharge education by video or face-to-face counseling .


`` Teach-back '' questions were used in both groups .


Although overall pharmacist time was reduced in the video counseling group ( P < @ ) , an interaction between prior warfarin use and counseling method ( P = @ ) suggests the difference between counseling methods was smaller in New Start participants .


Following adjustment , mean total time was reduced @ ( @ % CI = @-@ @ ) minutes ( adjusted P < @ ) in Restart participants and @ ( -@ to @ ) minutes ( adjusted P = @ ) in New Start participants receiving video counseling .


Postcounseling OAK test scores did not differ .


Age , gender , socioeconomic status , and years of education were not predictive of total time or OAK test score .


Use of informational videos coupled with teach-back questions significantly reduced pharmacist time spent on anticoagulation counseling without compromising short-term patient comprehension , primarily in patients with prior warfarin use .


Study results demonstrate that video technology provides an efficient method of anticoagulation counseling while achieving similar comprehension .


The postpericardiotomy syndrome ( PPS ) is a common complication following cardiac surgery .


The pathophysiology remains unclear , although evidence exists that surgical trauma and the use of cardiopulmonary bypass provoke an immune response leading to PPS .


We hypothesized that an intraoperative dose of dexamethasone decreases the risk of PPS , by reducing this inflammatory response .


We performed a subanalysis of the DECS study , which is a multicenter , double-blind , placebo-controlled , randomized trial of @,@ patients undergoing cardiac surgery with use of cardiopulmonary bypass .


The aim of the DECS study was to investigate whether a single intraoperative dose of @ mg/kg dexamethasone reduced the incidence of a composite of death , myocardial infarction , stroke , renal failure , or respiratory failure , within @ days of randomization .


In this substudy , we retrospectively analyzed the occurrence of PPS in @ patients who were included in the DECS trial and underwent valvular surgery .


Postpericardiotomy syndrome was diagnosed if @ of @ listed symptoms were present : unexplained fever , pleuritic chest pain , pericardial or pleural rub , new or worsening pericardial or pleural effusion .


All medical charts , x-rays , and echocardiograms were reviewed .


Secondary end point was the occurrence of complicated PPS , defined as PPS with need for evacuation of pleural effusion , pericardiocentesis , and tamponade requiring intervention or hospital readmission for PPS .


This is a blinded , single-center , post hoc analysis .


Postpericardiotomy syndrome occurred in @ patients ( @ % ) .


The incidence of PPS after dexamethasone compared with placebo was @ % vs @ % ( relative risk @ , @ % CI @-@ @ ) .


For complicated PPS , the incidence was @ % versus @ % ( relative risk @ , @ % CI @-@ @ , P = @ ) , respectively .


In patients undergoing valvular cardiac surgery , high-dose dexamethasone treatment had no protective effect on the occurrence of PPS or complicated PPS .


To assess the effect of two selective serotonin reuptake inhibitors ( SSRIs ) , fluvoxamine and citalopram , that markedly differ in their level of cytochrome P@ ( CYP ) @C@ inhibition , on the laboratory response to clopidogrel , a prodrug requiring metabolism by the CYP system , and especially CYP@C@ , to produce its active form .


Randomized , double-blind , crossover trial .


Clinical research unit of an academic medical center .


Fifteen healthy male volunteers .


All subjects received clopidogrel as a @-mg loading dose on day @ , followed by @mg/day on days @ and @ .


Platelet function was tested at baseline and then after clopidogrel treatment on day @ .


After a washout period of @weeks , subjects were randomly assigned in a double-blind manner to receive either citalopram @mg/day or fluvoxamine @mg/day for @days .


On day @ , platelet function was tested while receiving the SSRI treatment alone ; then , a @-mg clopidogrel loading dose was administered , followed by clopidogrel @mg/day on days @ and @ .


Platelet function was then reassessed on day @ while receiving the combination of the SSRI and clopidogrel .


The treatment protocol was then repeated after a washout period of @weeks in all subjects with the other SSRI .


The antiplatelet effects of fluvoxamine and citalopram and their interactions with clopidogrel were assessed .


The response to these three drugs was assessed by light transmittance aggregometry and vasodilator-stimulated phosphoprotein phosphorylation , reporting P@Y@ receptor reactivity .


Both fluvoxamine and citalopram tended to reduce adenosine diphosphate-induced aggregation : @ % at baseline , @ % while receiving citalopram , and @ % while receiving fluvoxamine .


All subjects had a good laboratory response to clopidogrel , with a mean aggregation of @ % and a mean platelet reactivity index of @ % ( p < @ compared with baseline for both methods ) .


Laboratory response to clopidogrel was significantly attenuated in the presence of fluvoxamine compared with the response in the presence of citalopram as tested both by aggregometry ( @ % vs @ % , p = @ ) and by vasodilator-stimulated phosphoprotein phosphorylation ( @ % vs @ % , p = @ ) .


Fluvoxamine attenuated the laboratory response to clopidogrel , possibly through inhibition of CYP@C@ , whereas citalopram did not affect this response .


These potential drug interactions should be taken into consideration in the selection of the appropriate antidepressant agent for patients who are treated with clopidogrel .


Millions of children worldwide suffer from posttraumatic stress disorder ( PTSD ) symptoms and other mental health problems due to repeated exposure to war or organized violence .


Forms of cognitive-behavioral therapy ( CBT ) are the most commonly used treatment for PTSD and appear to be effective for children as well , but little is known about the mechanisms of change through which they achieve their effectiveness .


Here we present the study protocol of a randomized controlled trial ( RCT ) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy ( NET ) , a CBT-based , manualized , short-term intervention for PTSD symptoms resulting from repeated traumatization , in immigrant children traumatized by war .


We are conducting a multicentre , pragmatic RCT in a usual care setting .


Up to @ @-@-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention ( NET ) and control ( treatment as usual , TAU ) groups of equal sizes .


The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group , on the primary outcomes of PTSD and depressive symptoms , psychological distress , resilience , and level of cognitive performance .


The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness .


The possible moderating effects of peritraumatic dissociation , level of cognitive performance , and gender on treatment effectiveness will also be considered .


We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience , and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions .


The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war .


The trial will also generate insights into the complex relationships between PTSD , memory functions , posttraumatic cognitions and cognitive performance in children , and help guide the future development and implementation of therapeutic interventions for PTSD in children .


Docosahexaenoic acid ( DHA ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases .


We recently assessed efficacy of high-dose DHA supplementation to slow vision loss in patients with X-linked retinitis pigmentosa ( XLRP ) in a randomized clinical trial .


Because DHA is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress .


Biosafety was monitored during the @-year trial to determine whether DHA supplementation was associated with identifiable risks .


Males ( n = @ ; @-@ years ) meeting entry criteria were enrolled .


The modified intent-to-treat cohort ( DHA = @ ; placebo = @ ) adhered to the protocol @ year .


Participants were randomized to an oral dose of @ mg/kg/d DHA or placebo plus a daily multivitamin .


Comprehensive metabolic analyses were assessed for group differences .


Treatment-emergent adverse events including blood chemistry metabolites were recorded .


By year @ , supplementation elevated plasma and red blood cell-DHA @ - and @-fold , respectively , compared with the placebo group ( P < @ ) .


Over the trial duration , no significant differences between DHA and placebo groups were found for vitamin A , vitamin E , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized LDL levels ( all P > @ ) .


Adverse events were transient and not considered severe ( e.g. , gastrointestinal -LSB- GI -RSB- irritability , blood chemistry alterations ) .


One participant was unable to tolerate persistent GI discomfort .


Long-term , high-dose DHA supplementation to patients with XLRP was associated with limited safety risks in this @-year trial .


Nevertheless , GI symptoms should be monitored in all patients taking high dose DHA especially those with personal or family history of GI disturbances .


( ClinicalTrials.gov number , NCT@ . )


A lack of physical activity and overconsumption of energy dense food is associated with overweight and obesity .


The neighbourhood environment may stimulate or hinder the development and/or maintenance of a healthy lifestyle .


To improve research on the obesogenicity of neighbourhood environments , reliable , valid and convenient assessment methods of potential obesogenic characteristics of neighbourhood environments are needed .


This study examines the reliability and validity of the SPOTLIGHT-Virtual Audit Tool ( S-VAT ) , which uses remote sensing techniques ( Street View feature in Google Earth ) for desk-based assessment of environmental obesogenicity .


A total of @ street segments in four Dutch urban neighbourhoods - heterogeneous in socio-economic status and residential density - were assessed using the S-VAT .


Environmental characteristics were categorised as walking related items , cycling related items , public transport , aesthetics , land use-mix , grocery stores , food outlets and physical activity facilities .


To assess concordance of inter - and intra-observer reliability of the Street View feature in Google Earth , and validity scores with real life audits , percentage agreement and Cohen 's Kappa ( k ) were calculated .


Intra-observer reliability was high and ranged from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall agreement of @ % ( k = @ ) .


Inter-observer reliability results ranged from substantial agreement @ % ( k = @ ) to high agreement , @ % ( k = @ ) , with an overall agreement of @ % ( k = @ ) .


Criterion validity was substantial to high for most of the categories ranging from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall score of @ % agreement ( k = @ ) .


These study results suggest that the S-VAT is a highly reliable and valid remote sensing tool to assess potential obesogenic environmental characteristics .


To describe the prognostic value of three novel biomarkers for acute adverse kidney events compared with routine biological markers .


We used high-end MS to quantify biomarkers predictive of acute kidney injury ( AKI ) and major adverse kidney events ( MAKE ) in @ adult patients after open heart surgery ( n = @ ) .


Early postoperatively measured LG@ ( a C-terminal fragment of perlecan ) , LTBP@ ( latent transforming growth factor binding protein-@ ) , Cathepsin L as well as two other renal biomarkers ( NGAL , Cystatin C ) had greater predictive value for AKI ( n = @ ) and MAKE ( n = @ ) compared with creatinine , urea and urine output .


LG@ , LTBP@ and Cathepsin L deserve further exploration as biomarkers for the early identification of patients at risk of MAKE .


To investigate the effects of exercise preconditioning on oxidative injury in the intestinal tissue of rats .


Sixty male Wistar rats were randomly divided into six groups as sham ( n = @ ) , ischemia-reperfusion ( n = @ ) , exercise ( n = @ ) , exercise plus ischemia-reperfusion ( n = @ ) , ischemic preconditioning ( n = @ ) , and ischemic preconditioning plus ischemia-reperfusion groups ( n = @ ) .


Tissue levels of malondialdehyde and activities of myeloperoxidase and superoxide dismutase , and serum levels of tumor necrosis factor-alpha and interleukin-@ were measured .


Intestinal tissue histopathology was also evaluated by light microscopy .


Tumor necrosis factor-alpha concentrations significantly decreased in the exercise group compared to the sham group ( p < @ ) .


Myeloperoxidase activity significantly increased and superoxide dismutase activity significantly decreased in ischemia-reperfusion group compared to the sham group ( p < @ ) .


Superoxide dismutase activity in the ischemic preconditioning and ischemic preconditioning plus ischemia-reperfusion groups were significantly higher compared to the ischemia-reperfusion and exercise groups ( p < @ ) .


Histopathologically , intestinal injury significantly attenuated in the exercise plus ischemia-reperfusion group compared to the ischemia-reperfusion group .


The results of the present study indicate that exercise training seems to have a protective role against intestinal ischemia-reperfusion injury ( Tab .


@ , Fig. @ , Ref .


To observe the sedative and analgesic effects of dexmedetomidine ( Dex ) and its influence on respiration and blood pressure , evaluate electrophysiological monitoring and explore the optimal dose of Dex for brain nuclei lesion in Parkinson 's disease ( PD ) patients .


Approved by hospital ethics committee , @ PD patients undergoing brain nuclei lesion ablation were randomly allocated into @ groups ( n = @ each ) .


No sedative anesthetic was used in group A ; In group B , Dex @ g/kg intravenously for initial bolus ( duration @ min ) and then @ gkg ( -@ ) h ( -@ ) continuous infusion ; In group C , Dex @ g/kg intravenously ( duration @ min ) for initial load and then @ gkg ( -@ ) h ( -@ ) continuous infusion .


The parameters of mean arterial pressure ( MAP ) , heart rate ( HR ) , pressure of end-tidal carbon dioxide ( P ETCO@ ) , respiratory rate , blood oxygen saturation ( SpO@ ) , observer 's assessment of alertness/sedation ( OAA/S ) and verbal rating score ( VRS ) were recorded at @ min ( baseline ) , @ min ( T@ ) , @ min ( T@ ) , @ min ( T@ ) , @ min ( T@ ) , @ min ( T@ ) and @ min ( T@ ) after the dosing of Dex .


HR and respiratory rate decreased in groups B and C compared with baseline .


In group C , P ETCO@ was much higher , compared with baseline ( P < @ ) .


Blood pressures of three groups were well-controlled .


The incidence of pain ( VRS @ ) in group A was significantly higher than those of groups B and C ( P < @ ) .


And the incidence of sedation ( OAA/S > @ ) in group C was much higher than those of groups A and B.


The electrophysiological signal of two patients in group C was severely affected .


At an initial intravenous dose of Dex @ g/kg and a maintenance dose of @ g kg ( -@ ) h ( -@ ) , electrophysiological monitoring for surgery is not affected in PD patients undergoing brain nuclei lesion ablation .


With a minimal interference of breath , Dex has not only well-controlled effects on sedation , analgesia and blood pressure , but also makes patients comfortable .


To characterize subgroups of subjects with schizophrenia from the Ziprasidone Observational Study of Cardiac Outcomes ( ZODIAC ) trial who either completed or attempted suicide and those who did not .


The ZODIAC , conducted between February @ and March @ , was an open-label , randomized , large simple trial of patients with schizophrenia ( N = @,@ ) followed up for @ year by unblinded investigators providing usual care in @ countries ; the primary outcome measure was nonsuicide mortality .


Every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm .


Primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models .


Usage of `` hard '' or `` soft '' methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized .


Overall incidences of subjects who either completed ( @/@ ,@ ) or attempted ( @/@ ,@ ) suicide were low , as were rates per person-time on assigned treatment analysis ( @ for completed and @ for attempted suicides per @ person-years of exposure ) .


The highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia .


Among all potential baseline risk factors for completed suicide examined , the variables most associated with completed suicide were history of suicide attempts ( OR = @ ; @ % CI , @-@ @ ) and usage of antidepressant medication ( OR = @ ; @ % CI , @-@ @ ) .


History of > @ hospitalizations in the past ( OR = @ ; @ % CI , @-@ @ ) and history of suicide attempts ( OR = @ ; @ % CI , @-@ @ ) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts .


Our results , obtained in a large prospective randomized study , confirm current clinical understanding regarding completed or attempted suicide in schizophrenia and the associated risk factors .


To evaluate the efficacy of a short-term intravenous infusion of levosimendan in patients with heart failure due to acute myocardial infarction ( AMI ) .


This was a randomized , single-center , single-blind study that included @ patients .


Patients were randomly divided into @ groups : @ received levosimendan ( n = @ ) and the other received placebo ( n = @ ) .


The study included multiple primary end points ( death , myocardial ischemia or worsening heart at the @ month follow-up ) and used a composite outcome .


The primary end point rate in the levosimendan group was lower than that in placebo group ( @ vs. @ % , HR @ , @ % CI @-@ @ , p = @ ) .


Moreover , the mortality rate at @ months was similar between the @ groups ( @ vs. @ % , HR @ , @ % CI @-@ @ , p = @ ) .


There was a higher incidence of myocardial ischemia in the levosimendan group at @ days than in the placebo group ( @ vs. @ % , HR @ , p = @ ) , but between @ and @ days , it was significantly lower in the levosimendan group than in the placebo group ( @ vs. @ % , HR @ , p = @ ) .


Short-term intravenous infusion of levosimendan appears to be more effective than placebo for treating patients with heart failure complicated by AMI .


To determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy ( ADT ) .


This is the first study to date that has investigated the potential role of exercise in preventing ADT toxicity rather than recovering from established toxicities .


Sixty-three men scheduled to receive ADT were randomly assigned to a @-month supervised exercise programme involving aerobic and resistance exercise sessions commenced within @ days of their first ADT injection ( @ men ) or usual care ( @ men ) .


The primary outcome was body composition ( lean and fat mass ) .


Other study outcomes included bone mineral density , physical function , blood biomarkers of chronic disease risk and bone turnover , general and prostate cancer-specific quality of life , fatigue and psychological distress .


Outcomes were compared between groups using analysis of covariance adjusted for baseline values .


Compared to usual care , a @-month exercise programme preserved appendicular lean mass ( P = @ ) and prevented gains in whole body fat mass , trunk fat mass and percentage fat with group differences of -@ kg ( P = @ ) , -@ kg ( P = @ ) and -@ % ( P < @ ) , respectively .


Significant between-group differences were also seen favouring the exercise group for cardiovascular fitness ( peak oxygen consumption @ mL/kg/min , P = @ ) , muscular strength ( @-@ @ kg , P @ ) , lower body function ( -@ s , P < @ ) , total cholesterol : high-density lipoprotein-cholesterol ratio ( -@ , P = @ ) , sexual function ( @ , P = @ ) , fatigue ( @ , P = @ ) , psychological distress ( -@ , P = @ ) , social functioning ( @ , P = @ ) and mental health ( @-@ @ , P @ ) .


There were no significant group differences for any other outcomes .


Commencing a supervised exercise programme involving aerobic and resistance exercise when initiating ADT significantly reduced treatment toxicity , while improving social functioning and mental health .


Concurrent prescription of supervised exercise when initiating ADT is therefore advised to minimise morbidity associated with severe hypogonadism .


Endoscopic mucosal resection ( EMR ) is simple and quick and has low complication rates .


However , the disadvantage of local recurrence or remnant rate limits the use of this technique .


We aimed to analyse the outcomes of conventional EMR and EMR with circumferential incision ( CIEMR ) , a simplified modification of EMR , in the endoscopic treatment of rectal carcinoid tumours .


A total of @ consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study .


These patients underwent endoscopic treatment from January @ to September @ and were randomly designated into CIEMR ( n = @ ) or EMR group ( n = @ ) .


En bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed .


The en bloc resection rate was not significantly different between the CIEMR and EMR groups ( @ % versus @ % , P > @ ) .


The pathological complete resection rate was higher in the CIEMR group than in the EMR group ( @ % versus @ % , P < @ ) .


The overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups .


No recurrence was observed in either the EMR or CIEMR group .


CIEMR optimises the procedure of EMR and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than EMR .


Thus , CIEMR may be preferable to conventional EMR for resection of rectal carcinoid tumours less than @ mm .


One-quarter of the world 's population will suffer from depression symptoms at some point in their lives .


Mental health services in developed countries are overburdened .


Therefore , cost-effective interventions that provide mental health care solutions such as Web-based psychotherapy programs have been proposed .


The intent of the study was to identify expectations regarding Web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects .


The expectations of untreated patients and health professionals were examined by means of interviews and focus groups .


There were @ participants ( @ patients with mild and moderate levels of depression , @ primary care physicians , and @ managers ; @ of them for interviews and @ for groups ) .


A thematic content analysis from the grounded theory for interviews , and an analysis of the discursive positions of participants based on the sociological model for groups were performed .


Interpretations were achieved by agreement between three independent analysts .


All participants showed a good general acceptance of Web-based psychotherapy , appreciating possible advantages and improvements .


Patients , physicians , and managers shared the same conceptualization of their expectations , although highlighting different aspects .


Patients focused on the need for individualized and personalized interaction , while professionals highlighted the need for the standardization of the program .


Physicians were concerned with extra workload , while managers were worried about optimizing cost-effectiveness .


Expectations of the different participants can conflict with each other .


Finding a balanced position among them is needed if we are to harmoniously implement effective Web-based interventions for depression in routine clinical practice .


EORTC trial @ examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer .


After a median follow-up of @ years , chemotherapy-irrespective of timing-significantly improved local control .


Adjuvant chemotherapy did not improve survival , but the Kaplan-Meier curves diverged , suggesting possible delayed benefit .


Here , we report the updated long-term results .


We randomly assigned patients with clinical stage T@ or T@ resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance .


Randomisation was done using minimisation with factors of institution , sex , T stage , and distance from the tumour to the anal verge .


Study coordinators , clinicians , and patients were aware of assignment .


Radiotherapy consisted of @ Gy to the posterior pelvis in @ fractions of @ Gy over @ weeks .


Each course of chemotherapy consisted of fluorouracil ( @ mg/m ( @ ) per day intravenous bolus ) and folinic acid ( leucovorin ; @ mg/m ( @ ) per day intravenous bolus ) .


For preoperative chemotherapy , two courses were given ( during weeks @ and @ of radiotherapy ) .


Adjuvant chemotherapy was given in four cycles , every @ weeks .


The primary endpoint was overall survival .


This analysis was done by intention to treat .


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


@ patients were randomly assigned to treatment between April , @ , and March , @ ( @ to preoperative radiotherapy and @ to each of the other three groups ) .


After a median follow-up of @ years ( IQR @-@ ) , @-year overall survival was @ % ( @ % CI @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( HR @ , @ % CI @-@ ; p = @ ) .


@-year overall survival was @ % ( @ % CI @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( HR @ , @ % CI @-@ , p = @ ) .


@-year disease-free survival was @ % ( @ % CI @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( HR @ , @ % CI @-@ ; p = @ ) .


@-year disease-free survival was @ % ( @ % CI @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( HR @ , @ % CI @-@ , p = @ ) .


At @ years , cumulative incidence of local relapse was @ % ( @ % CI @-@ ) with radiotherapy alone , @ % ( @-@ ) with neoadjuvant radiotherapy and chemotherapy , @ % ( @-@ ) with radiotherapy and adjuvant chemotherapy and @ % ( @-@ ) with both adjuvant and neoadjuvant chemotherapy ( p = @ ) .


There was no difference in cumulative incidence of distant metastases ( p = @ ) .


The frequency of long-term side-effects did not differ between the four groups ( p = @ ) .


Adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy ( with or without chemotherapy ) does not affect disease-free survival or overall survival .


Our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy .


New treatment strategies incorporating neoadjuvant chemotherapy are required .


A variety of techniques exist for the treatment of patients with great saphenous vein ( GSV ) varicosities .


Few data exist on the long-term outcomes of these interventions .


Patients undergoing conventional surgery , endovenous laser ablation ( EVLA ) and ultrasound-guided foam sclerotherapy ( UGFS ) for GSV varicose veins were followed up for @ years .


Primary outcome was obliteration or absence of the treated GSV segment ; secondary outcomes were absence of GSV reflux , and change in Chronic Venous Insufficiency quality-of-life Questionnaire ( CIVIQ ) and EuroQol - @D ( EQ-@D ) scores .


A total of @ legs were included ( @ conventional surgery , @ EVLA , @ UGFS ) , @ ( @ per cent ) of which were evaluated at final follow-up .


At @ years , Kaplan-Meier estimates of obliteration or absence of the GSV were @ ( @ per cent c.i. @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent in the conventional surgery , EVLA and UGFS groups respectively .


Absence of above-knee GSV reflux was found in @ ( @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent respectively .


CIVIQ scores deteriorated over time in patients in the UGFS group ( @ increase per year , @ per cent c.i. @ to @ ) , and were significantly worse than those in the EVLA group ( -@ decrease per year , @ per cent c.i. -@ to @ ) ( P = @ ) .


CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups ( @ increase per year , @ per cent c.i. -@ to @ ) .


EQ-@D scores improved equally in all groups .


EVLA and conventional surgery were more effective than UGFS in obliterating the GSV @ years after intervention .


UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery .


Chemotherapy-induced peripheral neuropathy ( CIPN ) occurs in as high as @ % of patients receiving certain types of chemotherapy agents .


The FDA has yet to approve a therapy for CIPN .


The aim of this multicenter , phase III , randomized , double-blind , placebo-controlled trial was to investigate the efficacy of @ % ketamine plus @ % amitriptyline ( KA ) cream for reducing CIPN .


Cancer survivors who completed chemotherapy at least @ month prior and had CIPN ( > @ out of @ ) were enrolled ( N = @ ) .


CIPN was assessed using average scores from a @-day daily diary that asks patients to rate the average `` pain , numbness , or tingling in -LSB- their -RSB- hands and feet over the past @ h '' on an @-point numeric rating scale at baseline and @ weeks post intervention .


ANCOVA was used to measure differences in @-week CIPN with effects including baseline CIPN , KA treatment arm , and previous taxane therapy ( Y/N ) .


The KA treatment showed no effect on @-week CIPN scores ( adjusted mean difference = -@ , p = @ ) .


This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors .


This study investigated the long-term safety of rivastigmine ( @ mg/d capsules , @ mg/@ h patch ) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia .


This was a @-week , prospective , open-label , randomized study in patients aged @ to @ years .


Primary outcomes included incidence of , and discontinuation due to , predefined adverse events ( AEs ) potentially arising from worsening of Parkinson disease motor symptoms with capsules .


Secondary outcomes included frequency of AEs/serious AEs .


Efficacy outcomes included Alzheimer 's Disease Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , Neuropsychiatric Inventory ( NPI-@ ) , and Mattis Dementia Rating Scale ( MDRS ) .


Five hundred eighty-three patients were randomized to rivastigmine capsules ( n = @ ) or patch ( n = @ ) .


Incidence of predefined AEs was @ % for capsules , @ % for patch ; discontinuation due to worsening of motor symptoms was @ % and @ % , respectively .


Most common AEs were nausea ( capsules , @ % ; patch , @ % ) , tremor ( @ % ; @ % ) , fall ( @ % ; @ % ) , vomiting ( @ % ; @ % ) , and application site erythema ( @ % ; @ % ) .


Significant efficacy in favor of capsules was observed at weeks @ to @ on MDRS ; @ and @ on NPI-@ ; weeks @ and @ on ADCS-ADL .


In patients with Mini-Mental State Examination ( MMSE ) greater than @ , no differences in efficacy on MDRS and ADCS-ADL were observed at any time point ; significant differences in favor of capsules were maintained in patients with MMSE less than or equal to @ .


This study supports the long-term safety of rivastigmine in Parkinson disease dementia .


The rate of worsening of motor symptoms was in the range expected due to the natural progression of Parkinson disease , no new or unexpected safety issues emerged in the long-term .


This study delineates activities of daily living ( ADL ) and instrumental activities of daily living ( IADL ) black-white disparity trends by age , period , and cohort ( APC ) and explores sociodemographic contributors of cohort-based disparity trends .


We utilized multiple cross-sectional waves of National Health Interview Survey data ( @-@ ) to describe APC trends of ADL and IADL disparities using a cross-classified random effect model .


Further , we decomposed the cohort-based disparity trends using Fairlie 's decomposition method for nonlinear outcomes .


The crossover ADL and IADL disparities ( whites > blacks ) occurring at age @ increased with age and reached a plateau at age of @ , whereas period-based ADL and IADL disparities remained constant for the past @ decades .


The cohort disparity trends for both disabilities showed a decline with each successive cohort except for ADL disparity among women .


We examined the role of aging on racial disparity in disability and found support for the racial crossover effect .


Further , the racial disparity in disability will disappear should the observed pattern of declining cohort-based ADL and IADL disparities persist .


Although education , income , and marital status are important sociodemographic contributors to cohort disparity trends , future studies should investigate individual behavioral health determinants and cohort-specific characteristics that explain the cohort-based racial difference in ADL and IADL disabilities .


Randomized trials have not shown major survival benefits when induction chemotherapy plus standard therapy is compared with standard therapy alone in patients with oral squamous cell carcinoma ( OSCC ) .


Induction chemotherapy is likely to be effective for biologically distinct subgroups and biomarker development may lead to identification of patients whose tumors are likely to respond to a particular treatment .


We evaluated immunohistochemical staining for GDF@ in pretreatment biopsy specimens of @ of @ OSCC patients who were treated in a prospective , randomized , phase III trial on induction chemotherapy including docetaxel , cisplatin and @-fluorouracil ( TPF ) .


Relationship between GDF@ intervention and cell proliferation , migration , invasion , colony formation and tumorigenicity was analyzed using in vitro and in vivo OSCC models .


Low GDF@ expression predicted a better survival in OSCC patients , especially overall survival -LSB- P = @ , hazard ratio ( HR ) = @ -RSB- and distant metastasis-free survival ( DMFS ; P = @ , HR = @ ) .


cN + patients with low GDF@ expression benefitted from induction TPF in overall survival ( P = @ , HR = @ ) and DMFS ( P = @ , HR = @ ) , cN - patients with high GDF@ expression benefitted from induction TPF in overall survival ( P = @ , HR = @ ) , disease-free survival ( P = @ , HR = @ ) , locoregional recurrence-free survival ( P = @ , HR = @ ) and DMFS ( P = @ , HR = @ ) .


Decreased GDF@ expression in OSCC lines significantly inhibited cell proliferation , migration , invasion , colony formation and tumorigenesis through increased phosphorylation of AKT and ERK@/@ ( P < @ ) .


Likewise , overexpression of GDF@ significantly promoted cell proliferation , migration , invasion and colony formation through decreased phosphorylation of AKT and ERK@/@ ( P < @ ) .


GDF@ expression can be used as a prognostic biomarker for OSCC , and as a predictive biomarker for benefitting from TPF induction chemotherapy .


GDF@ promotes tumorigenesis and progression through phosphorylation of AKT and ERK@/@ in OSCC .


The clinical trial in this study was registered with www.ClinicalTrials.gov ( NCT@ ) .


The continued use of angiotensin-converting enzyme inhibitors ( ACEIs ) and angiotensin II subtype I receptor antagonists ( ARBs ) medications in the preoperative period has been reported to be associated with intraoperative hypotension that can be unresponsive to pressor drugs .


As a result , several investigators suggested discontinuation of these medications before scheduled surgery but did not report on unintended consequences that might result from discontinuation .


We conducted a prospective , single-blind , randomized trial to observe the effect of the medications on preoperative arterial blood pressure recordings in patients presenting for ambulatory and same-day surgery .


Six hundred forty-four patients presenting for ambulatory and same-day surgery were enrolled prospectively between @ and @ and randomly assigned to @ groups based on continuation or discontinuation of ACEIs and ARBs .


An intention-to-treat analysis was performed .


The primary outcome was presence of hypertension ( HTN ) immediately before surgery .


Secondary outcomes included surgical cancellations due to HTN , prolongation of hospitalization , adverse clinical events , and HTN in the postoperative period .


Data for @ patients were analyzed .


There were @ patients in the discontinuation group and @ patients in the continuation group .


Discontinuation of ACEIs and ARBs on the day of surgery was not associated with increased prevalence of preoperative HTN ( P = @ ) .


The upper bound of a @ % confidence interval for the difference in prevalence of Stage @ and @ HTN between study arms indicates that discontinuation of study medication is unlikely to be associated with an increase in Stage @ HTN of > @ percentage points and in Stage @ HTN of no > @ percentage points .


Discontinuation was not associated with an increase in postoperative HTN , with prolongation of hospitalization or with adverse clinical events .


Discontinuing ACEIs and ARBs in patients on the day of surgery did not result in a substantively increased incidence of pre - or postoperative HTN compared with patients who continued these medications on the day of surgery .


The results provide an evidentiary basis for the safety of discontinuing ACEIs and ARBs on the day of surgery without increasing adverse hemodynamic outcomes .


To evaluate efficacy and safety of superior hypogastric plexus neurolysis ( SHN ) for treatment of interstitial cystitis ( IC ) - bladder pain syndrome ( BPS ) in comparison with bladder hydrodistention ( HD ) .


In a prospective study , @ female patients were randomly allocated to receive either SHN or HD .


Patients were evaluated by recording the O'Leary-Sant IC symptom indices , IC problem indices , pain visual analog scale ( VAS ) , number of daytime frequency , and nocturia .


Pressure flow study was conducted for all patients .


Intraoperative and postoperative changes and adverse events were recorded .


Basal IC symptom indices , IC problem indices , and VAS scores were comparable between both groups ( P = @ , @ , and @ , respectively ) .


There was no statistically significant difference between both groups with respect to urodynamic parameters .


Only pain VAS at first week was improved in SHN in comparison with HD ( P = @ ) .


Thereafter , all parameters were significantly improved in favor of the HD group at @ - and @-week visits .


Adverse events in both groups were ranked as Grade @ Clavien-Dindo classification including transient hematuria in the HD group and transient back ache in the SHN group .


Despite effective pain control in cases with IC-BPS after SHN , it lacks durability .


It seems that SHN in its current form is not to be a suitable line of treatment for IC-BPS .


Multimodality treatment would be needed for proper control of patients ' symptoms .


Recent studies show that cerebral - amyloid ( A ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals .


To examine the association between measures of arterial stiffness and change in A deposition over time .


Deposition of A was determined in a longitudinal observational study of aging by positron emission tomography using the Pittsburgh compound B twice @ years apart in @ nondemented individuals @ years and older .


Arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan .


All measures were performed under standardized conditions .


Pulse wave velocity ( PWV ) was measured in the central ( carotid-femoral and heart-femoral PWV ) , peripheral ( femoral-ankle PWV ) , and mixed ( brachial-ankle PWV ) vascular beds .


The change in A deposition over @ years was calculated from the @ individuals with repeat A-positron emission tomography .


The proportion of A-positive individuals increased from @ % at baseline to @ % at follow-up .


Brachial-ankle PWV was significantly higher among A-positive participants at baseline and follow-up .


Femoral-ankle PWV was only higher among A-positive participants at follow-up .


Measures of central stiffness and blood pressure were not associated with A status at baseline or follow-up , but central stiffness was associated with a change in A deposition over time .


Each standard deviation increase in central stiffness ( carotid-femoral PWV , P = @ ; heart-femoral PWV , P = @ ) was linked with increases in A deposition over @ years .


This study showed that A deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of A in the brain , especially in this age group .


The association between A deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral A deposition .


This study investigates measures of mindfulness meditation ( MM ) as a mental practice , in which a resting but alert state of mind is maintained .


A population of older people with high stress level participated in this study , while electroencephalographic ( EEG ) and respiration signals were recorded during a MM intervention .


The physiological signals during meditation and control conditions were analyzed with signal processing .


EEG and respiration data were collected and analyzed on @ novice meditators after a @-week meditation intervention .


Collected data were analyzed with spectral analysis , phase analysis and classification to evaluate an objective marker for meditation .


Different frequency bands showed differences in meditation and control conditions .


Furthermore , we established a classifier using EEG and respiration signals with a higher accuracy ( @ % ) at discriminating between meditation and control conditions than a classifier using the EEG signal only ( @ % ) .


Support vector machine ( SVM ) classifier with EEG and respiration feature vector is a viable objective marker for meditation ability .


This classifier should be able to quantify different levels of meditation depth and meditation experience in future studies .


This randomised phase II trial aimed to compare efficacy of the irreversible ErbB family blocker , afatinib , with cetuximab in patients with KRAS wild-type metastatic colorectal adenocarcinoma ( mCRC ) with progression following oxaliplatin - and irinotecan-based regimens .


Efficacy in patients with KRAS mutations was also evaluated .


Patients with KRAS wild-type tumours were randomised @:@ to afatinib ( @ mg/day , increasing to @ mg/day if minimal toxicity ) or cetuximab weekly ( @ mg/m@ loading dose , then @ mg/m@/week ) according to number of previous chemotherapy lines .


All patients with KRAS-mutated tumours received afatinib .


Primary end-points were objective response ( OR ) for the wild-type group and disease control for the KRAS-mutated group .


Secondary end-points were progression-free survival ( PFS ) and overall survival ( OS ) .


Patients with KRAS wild-type tumours ( n = @ ) received afatinib ( n = @ ) or cetuximab ( n = @ ) .


Unconfirmed and confirmed ORs were @ % and @ % for afatinib versus @ % and @ % for cetuximab ( odds ratio : @ -LSB- P = @ -RSB- and < @ , respectively ) .


Median PFS was @ and @ days for afatinib and cetuximab , respectively .


Median OS was @ days with afatinib but not reached for cetuximab .


In the KRAS-mutated group ( n = @ ) , five ( @ % ) patients achieved confirmed disease control ( stable disease ; P = @ -LSB- comparison versus @ % -RSB- ) ; no ORs were reported .


Median PFS and OS were @ and @days , respectively .


Most frequent treatment-related adverse events were diarrhoea and rash across groups .


The efficacy of afatinib was inferior to cetuximab in patients with KRAS wild-type mCRC .


In patients with KRAS-mutated tumours , disease control was modest with afatinib .


Afatinib had a manageable safety profile .


Heart failure and left ventricular systolic dysfunction ( LVSD ) are common in patients with permanent pacemakers , but whether right ventricular ( RV ) pacing is contributory or merely a bystander in patients with more severe cardiac disease is controversial .


The aim of the present study was to determine whether reprogramming of existing pacemakers to reduce RV pacing is safe and leads to improvements in cardiac function .


This was a prospective service evaluation of the effects of optimising pacemaker programming to avoid RV pacing in @ consecutive attendees of a teaching hospital pacemaker clinic without complete heart block .


The main outcome measures were left ventricular ejection fraction ( LVEF ) , N-terminal pro-B-type natriuretic peptide ( NT-pro-BNP ) levels , quality of life and cardiopulmonary exercise testing at baseline and after @ months .


At @ months , the protocol reduced absolute RV pacing by a mean of @ % ( @ % CI @ % to @ % ) ( p < @ from baseline ) and resulted in a mean absolute improvement in LVEF of @ % ( @ % to @ % ) ( p < @ from baseline ) but no reduction in exercise capacity , NT-pro-BNP or quality of life .


There was a relationship between the magnitude of change in EF and the reduction in RV pacing ( p = @ ) and changes in NT-pro-BNP seemed to relate to change in RV pacing ( p = @ ) .


Programming standard pacemakers to avoid RV pacing is safe , does not adversely affect patients ' symptoms or quality of life and is associated with improved LV function , related to the reductions in RV pacing percentage .


New technologies could facilitate changes in lifestyle and improve public health .


However , no large randomized , controlled studies providing scientific evidence of the benefits of their use have been made .


The aims of this study are to develop and validate a smartphone application , and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity .


An evaluation is also made of the effect of modifying habits upon vascular structure and function , and therefore on arterial aging .


A randomized , double-blind , multicenter , parallel group clinical trial will be carried out .


A total of @ subjects under @years of age from the EVIDENT trial will be included .


Counseling common to both groups ( control and intervention ) will be provided on adaptation to the Mediterranean diet and on physical activity .


The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity , and will use the application for three months .


The main study endpoints will be the changes in physical activity , assessed by accelerometer and the @-day Physical Activity Recall ( PAR ) interview , and adaptation to the Mediterranean diet , as evaluated by an adherence questionnaire and a food frequency questionnaire ( FFQ ) .


Evaluation also will be made of vascular structure and function based on central arterial pressure , the radial augmentation index , pulse velocity , the cardio-ankle vascular index , and carotid intima-media thickness .


Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications , and may contribute to generalize their application in favor of improved population health .


To investigate the safety , feasibility and preliminary efficacy of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) over the cerebellum in ataxic patients with acute posterior circulation stroke .


Randomized , double-blind , sham-controlled pilot study .


Thirty-two ataxic patients with posterior circulation stroke were randomized to real ( n = @ ) and sham ( n = @ ) rTMS groups .


Patients received @ @-min sessions of @ Hz cerebellar rTMS over @ consecutive days .


Compliance and adverse events for the rTMS sessions were checked .


The @-m walk test ( @MWT ) and Berg Balance Scale ( BBS ) were completed before rTMS , immediately and @ month after the last rTMS session .


Compliance with the rTMS was @ % and no adverse events were reported in either group .


@MWT and BBS of real rTMS group improved significantly ( p < @ ) .


Percentage changes immediately after the last rTMS session for time and steps in the @MWT and BBS in the real vs sham group were : -@ @ % vs -@ @ % , -@ @ % vs -@ @ % and @ @ % vs @ @ % , respectively .


This study demonstrated that @ Hz rTMS over the cerebellum is safe , feasible and may have a beneficial effect in ataxic patients with posterior circulation stroke .


Because of its contribution to dietary diversity and to favorable intakes of micronutrients , including iron and zinc , meat is hypothesized to be a valuable complementary food for the infant and young child .


However , the evidence base remains limited .


To compare the difference in anthropometric measurements of rural Chinese infants and toddlers @ to @ months of age who received a daily supplement of meat or cereal for @ months .


This cluster-randomized , controlled study provided a daily supplement of either meat ( n = @ , @ clusters ) or cereal ( n = @ , @ clusters ) starting as a first complementary food at @ months of age .


Anthropometric measurements were assessed longitudinally .


After @ months of intervention , the meat group ( @ @ cm ) had greater ( p = @ ) linear growth than the cereal group ( @ @ cm ) and a smaller decrease in length-for-age z-score ( LAZ ) over time ( -@ @ in the meat group vs. -@ @ in the cereal group ) , after adjustment for baseline length , LAZ , maternal education , work status , and maternal height and weight .


Linear growth was modestly greater in the meat group than in the cereal group .


LAZ was substantially negative at @ months , and the intervention did not prevent ongoing decline over the course of the study .


Poor sleep is prevalent in patients with systemic inflammatory disorders , including rheumatoid arthritis , and , in addition to fatigue , pain , depression and inflammation , is associated with an increased risk of co-morbidity and all-cause mortality .


Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue , no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis .


The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep , assessed both objectively and subjectively in patients with rheumatoid arthritis .


A randomized controlled trial including @ patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group .


The intervention consists of @ session intermittent aerobic exercise training on a bicycle ergometer three times a week .


Patients are evaluated according to objective changes in sleep as measured by polysomnography ( primary outcome ) .


Secondary outcomes include changes in subjective sleep quality and sleep disturbances , fatigue , pain , depressive symptoms , physical function , health-related quality of life and cardiorespiratory fitness .


This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis , which is considered important in promotion of health and well-being .


As such , the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis .


Syncope is a cause of significant morbidity in sick sinus syndrome ( SSS ) which may not be resolved with permanent pacemaker therapy .


We aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with SSS .


We studied @ patients ( mean age @ years , SD @ ) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing ( n = @ ) or rate-responsive dual chamber pacing ( n = @ ) .


Main outcome measures were patient-reported syncope after pacemaker implantation and mortality .


Mean follow-up was @ years ( SD @ ) .


A total of @ ( @ % ) patients experienced syncope after pacemaker implantation ( @ ( @ % ) from the rate-responsive single chamber pacing group , and @ ( @ % ) from the rate-responsive dual chamber pacing group .


Predictors of syncope post pacemaker implantation included : age @-@ years ( HR @ , @ % CI @ to @ , p = @ ; reference range @-@ years ) , age @ years ( HR @ , @ % CI @ to @ , p = @ ) , syncope prior to pacemaker implant ( HR @ , @ % CI @ to @ , p < @ ) , previous myocardial infarction ( HR @ , @ % CI @ to @ , p = @ ) , heart failure ( HR @ , @ % CI @ to @ , p = @ ) , and high Charlson comorbidity index ( HR @ , @ % CI @ to @ , p = @ ) .


Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted HR @ , @ % CI @ to @ , p < @ ) .


Syncope in paced patients with SSS is common , and is associated with higher mortality .


The predictors identified in this study suggest a multifactorial aetiology of syncope .


Surgery remains the dominant treatment for large-bowel obstruction , with emerging data on self-expanding metallic stents .


The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression .


This study reports on a randomized control trial ( registry number ACTRN@ ) .


This study was conducted at Royal Prince Alfred Hospital , Sydney , and Western Hospital , Melbourne .


Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion .


The primary end point was differences in EuroQOL EQ-@D quality of life .


Secondary end points included overall survival , @-day mortality , stoma rates , postoperative recovery , complications , and readmissions .


Fifty-two patients of @ needed to reach the calculated sample size were evaluated .


Stent insertion was successful in @ of @ ( @ % ) patients .


The remaining @ patients required a stoma compared with @ of @ ( @ % ) surgery group patients ( p < @ ) .


There were no stent-related perforations or deaths .


The surgery group had significantly reduced quality of life compared with the stent group from baseline to @ and @ weeks ( p = @ and p = @ ) , and from baseline to @ months ( p = @ ) in favor of the stent group , whereas both reported reduced quality of life .


The stent group had an @ % @-day mortality compared with @ % for the surgery group ( p = @ ) .


Median survival was @ and @ months for the groups ( p = @ ) .


The stent group had significantly reduced procedure time ( p = @ ) , postprocedure stay ( p = @ ) , days nothing by mouth ( p = @ ) , and days before free access to solids ( p = @ ) .


This study was limited by the lack of an EQ-@D Australian-based population set .


Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet , decreased stoma rates , reduced postprocedure stay , and some quality-of-life benefits .


To identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts .


In this cross-sectional study , we evaluated the health history , laboratory values , and brain magnetic resonance imaging findings of participants with sickle cell disease ( hemoglobinSS or hemoglobinS-thalassemia ) with no history of overt stroke or seizures .


Participants characterized headache severity and quality .


Migraine was defined by International Headache Society criteria modified for increased sensitivity in children .


Neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists .


The cohort included @ children ( @ % males ) , ranging in age from @ to @ years ( mean age , @ years ) .


Of these children , @ ( @ % ) reported recurrent headaches , and @ ( @ % ) reported migraines .


In multivariable logistic regression analyses , both were associated with lower steady-state hemoglobin ( P = @ for headaches ; P < @ for migraines ) and higher pain rate ( P < @ for headaches ; P < @ for migraines ) , defined as the number of admissions requiring opioids in the previous @ years .


The presence of silent cerebral infarction was not associated with recurrent headaches or migraines .


Only @ % ( @ of @ ) of children with recurrent headaches received medication for headache prophylaxis .


Recurrent headaches and migraines are common and undertreated in children with sickle cell disease .


Low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines ; whereas , silent cerebral infarction is not .


Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease .


Its effect in patients using fixed combinations of inhaled corticosteroids and longacting @ agonists is unknown .


We postulated that roflumilast would reduce exacerbations in patients with severe chronic obstructive pulmonary disease at risk for exacerbations , even in combination with inhaled corticosteroid and longacting @ agonist treatment .


For this @-year double-blind , placebo-controlled , parallel group , multicentre , phase @-@ trial , the Roflumilast and Exacerbations in patients receiving Appropriate Combination Therapy ( REACT ) study , we enrolled patients with severe chronic obstructive pulmonary disease from @ centres ( outpatient clinics , hospitals , specialised pulmonologists , and family doctors ) in @ countries .


Eligible patients were @ years of age or older with a smoking history of at least @ pack-years and a diagnosis of chronic obstructive pulmonary disease with severe airflow limitation , symptoms of chronic bronchitis , and at least two exacerbations in the previous year .


We used a computerised central randomisation system to randomly assign patients in a @:@ ratio to the two treatment groups : roflumilast @ g or placebo given orally once daily together with a fixed inhaled corticosteroid and longacting @ agonist combination .


Background tiotropium treatment was allowed .


All patients and investigators were masked to group assignment .


The primary outcome was the rate of moderate to severe chronic obstructive pulmonary disease exacerbations per patient per year , analysed by intention to treat .


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


Between April @ , @ , and May @ , @ , we enrolled @ eligible participants and randomly assigned @ to the roflumilast group and @ to the placebo group .


The rate of moderate-to-severe chronic obstructive pulmonary disease exacerbations was @ % lower in the roflumilast group than in the placebo group according to a Poisson regression analysis ( roflumilast @ vs placebo @ ; rate ratio -LSB- RR -RSB- @ -LSB- @ % CI @-@ -RSB- , p = @ ) , and @ % lower according to a predefined sensitivity analysis using negative binomial regression ( @ vs @ ; @ -LSB- @-@ -RSB- , p = @ ) .


Adverse events were reported by @ ( @ % ) of @ patients receiving roflumilast and by @ ( @ % ) of @ patients in the placebo group ; adverse event-associated patient withdrawal from the study was also more common in the roflumilast group ( @/@ -LSB- @ % -RSB- ) than in the placebo group ( @/@ -LSB- @ % -RSB- ) .


The most frequently reported serious adverse events were chronic obstructive pulmonary disease exacerbations and pneumonia , and @ ( @ % ) deaths occurred in the roflumilast group compared with @ ( @ % ) in the placebo group .


Our findings suggest that roflumilast reduces exacerbations and hospital admissions in patients with severe chronic obstructive pulmonary disease and chronic bronchitis who are at risk of frequent and severe exacerbations despite inhaled corticosteroid and longacting @ agonist therapy , even in combination with tiotropium .


To test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait .


Single-blinded randomized clinical trial .


University research laboratory .


Adults ( N = @ ) aged @ years with gait speed > @ m/s and impaired motor skill ( figure-of-@ walk time > @s ) .


The @ interventions included a task-oriented motor learning and a standard exercise program ; both interventions included strength training .


Both lasted @ weeks , with twice-weekly , @-hour , physical therapist-supervised sessions .


Two measures of the motor control of gait , gait variability and smoothness of walking , were assessed pre - and postintervention by assessors masked to the treatment arm .


Of @ randomized subjects , @ completed the trial ( mean age SD , @ y ) .


The motor learning group improved more than the standard group in double-support time variability ( @ m/s vs @ m/s ; adjusted difference -LSB- AD -RSB- = @ , P = @ ) .


Smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions ( usual : AD = @ , P = @ ; narrow : AD = @ , P = @ ; dual task : AD = @ , P = @ ) .


Smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path ( AD = @ , P = @ ) and dual-task ( AD = @ , P = @ ) conditions .


Among older adults with subclinical walking difficulty , there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking , while standard exercise does not .


Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults , and needs to be evaluated in a definitive larger trial .


In an attempt to investigate new strategies aimed at reducing inflammation in osteoarthritis , the anti-inflammatory effect of Elaeagnus angustifolia L. as a complementary treatment was evaluated in females with knee osteoarthritis .


In this clinical trial , @ females with mild to moderate osteoarthritis were assigned to two intervention and one placebo groups .


In addition to the conventional therapy , the patients in intervention groups received @g/day of E. angustifolia L. medulla and whole fruit powders respectively for @ weeks .


The levels of tumor necrosis factor-alpha ( TNF - ) , interleukine-@ ( IL-@ ) , interleukine-@ ( IL-@ ) , matrix metalloproteinase-@ ( MMP-@ ) and -@ ( MMP-@ ) were measured with human ELISA kits .


Paired t-test and ANOVA were used for statistical analysis .


The statistically significant decrease was observed in the mean levels of serum TNF - in the medulla ( @ ) and whole fruit ( @ ) groups after @ weeks of supplementation .


In contrast to the placebo group , there was a significant rise in the mean levels of serum IL-@ in medulla ( p-value = @ ) and whole fruit groups ( p-value = @ ) at the end of study .


The interventions resulted in significant decrease in the mean levels of serum MMP-@ in the medulla ( @ ) and whole fruit ( @ ) groups .


After the interventions , no significant changes were observed in the serum IL-@ and MMP-@ levels .


Daily supplementation with E. angustifolia L. in both forms of medulla and whole fruit powders appeared to be effective for decreasing inflammatory cytokines ( TNF - and MMP-@ ) and enhancing anti-inflammatory cytokines ( IL-@ ) .


We investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type @ diabetes .


We studied @ adults ( @ men , @ women , mean age @ @ ) who had been recruited to the Early ACTivity in Diabetes ( Early ACTID ) randomised controlled trial .


C-reactive protein ( CRP ) , adiponectin , soluble intracellular adhesion molecule-@ ( sICAM-@ ) , interleukin-@ ( IL-@ ) , and accelerometer-determined sedentary time and moderate-vigorous physical activity ( MVPA ) were measured at baseline and after six-months .


Linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation .


At baseline , associations between sedentary time and IL-@ were observed in men and women , an association that was attenuated following adjustment for waist circumference .


After @ months of follow-up , sedentary time was reduced by @ @ h per day in women , with the change in sedentary time predicting CRP at follow-up .


Every hour decrease in sedentary time between baseline and six-months was associated with @ % ( @ , @ ) lower CRP .


No changes in sedentary time between baseline and @ months were seen in men .


Higher sedentary time is associated with IL-@ in men and women with type @ diabetes , and reducing sedentary time is associated with improved levels of CRP in women .


Interventions to reduce sedentary time may help to reduce inflammation in women with type @ diabetes .


To investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome ( ACS ) patients complicating with dyslipedemia .


One hundred and four hospitalized patients with established ACS and increased serum triglycerides ( TG ) levels and/or low serum levels of high density lipoprotein cholesterol ( HDL-C ) were selected .


Except for conventional therapy , the patients were randomly divided into @ groups : control group ( n = @ ) , treated with atorvastatin @ mg qn or other statin equivalent to @ mg atorvastatin ; treatment group ( n = @ ) , treated with the same dose statin plus bezafibrate @ mg bid .


The serum levels of total cholesterol ( TC ) , TG , low-density lipoprotein cholesterol ( LDL-C ) and HDL-C were assessed before and after @ and @ weeks treatment , side effects and adverse events were recorded .


After @ weeks treatment , the serum levels of TC , TG and LDL-C in two groups were significantly reduced compared to baseline ( all P < @ ) , which were further declined after @ weeks treatment , and the reduction was more significant in treatment group ( @ % , @ % and @ % , respectively ) than in control group ( @ % , @ % and @ % , respectively ) ( all P < @ ) .


After treatment , the serum levels of HDL-C in the two groups were significantly higher than the baseline levels , especially after @ weeks treatment ( all P < @ ) , and the elevations of HDL-C levels in control group and in treatment group were @ % and @ % , respectively , but there were no significant difference between the two groups ( P > @ ) .


After @ weeks , the rates reaching to target goals of LDL-C , TG , HDL-C , and non-HDL-C levels in the treatment group ( @ % , @ % , @ % , @ % and @ % , respectively ) were significantly higher than those in the control group ( @ % , @ % , @ % , @ % and @ % , respectively , all P < @ ) .


No serious side effects were observed in the two groups during the treatment period .


The combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in ACS patients complicating with increased TG and ( or ) decreased HDL-C .


Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser ( LFQS ) and glycolic acid ( GA ) peeling have been reported as a treatment option for melasma .


However , there are limited data on their efficacy in men .


To compare the efficacy and safety of LFQS monotherapy with combined LFQS and @ % GA peeling in male patients with melasma .


Fifteen males with mixed type melasma were randomized to receive @ weekly sessions of LFQS on one side of the face and LFQS plus @ % GA peeling on the contralateral side and were followed for @ weeks .


Twelve patients completed the protocol .


Mean relative lightness index ( RL * I ) of the combined treatment side was lowered throughout the study period , with the maximal improvement of @ % reduction at the fourth week follow-up ( p = @ ) .


Patient self-assessment was favorable in the combined treatment .


However , the mean RL * I increased at @ and @ weeks of follow-up .


One subject ( @ % ) developed guttate hypopigmentation , which did not resolve by the @-week follow-up .


Low-fluence Q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser combined with GA peeling temporarily reduced melasma in men , but the incidence of side effects does not justify the short-lived benefits of this procedure .


This technique requires further study .


While physical exercise as adjunctive treatment for major depression has received considerable attention in recent years , the evidence is conflicting .


This study evaluates the effects of two different add-on treatments : exercise and basic body awareness therapy .


Randomized controlled trial with two intervention groups and one control , including @ adults on antidepressant medication , who fulfilled criteria for current major depression as determined by the Mini International Neuropsychiatric Interview .


Interventions ( @ weeks ) were aerobic exercise or basic body awareness therapy ( BBAT ) , compared to a single consultation with advice on physical activity .


Primary outcome was depression severity , rated by a blinded assessor using the Montgomery Asberg Rating Scale ( MADRS ) .


Secondary outcomes were global function , cardiovascular fitness , self-rated depression , anxiety and body awareness .


Improvements in MADRS score ( mean change = -@ , @ % CI ( -@ to -@ ) , p = @ ) and cardiovascular fitness ( mean change = @ ml oxygen/kg/min , @ % CI ( @ to @ ) , p = @ ) were observed in the exercise group .


Per-protocol analysis confirmed the effects of exercise , and indicated that BBAT has an effect on self-rated depression .


The small sample size and the challenge of missing data .


Participants positive expectations regarding the exercise intervention need to be considered .


Exercise in a physical therapy setting seems to have effect on depression severity and fitness , in major depression .


Our findings suggest that physical therapy can be a viable clinical strategy to inspire and guide persons with major depression to exercise .


More research is needed to clarify the effects of basic body awareness therapy .


Interest in online positive psychology interventions ( OPPIs ) continues to grow .


The empirical literature has identified design factors ( e.g. , variety and duration of activities ) and moderators ( e.g. , personality traits ) that can influence their effectiveness .


A randomized controlled trial tested an empirically informed OPPI designed to promote self-efficacy and an optimistic outlook .


Pessimism was included as a trait moderator .


Participants ( N = @ ) were English-speaking adults interested in becoming happier .


They were randomly assigned to complete either an OPPI cultivating optimism or a control condition writing about daily activities for @ weeks .


Follow-up assessments occurred @ and @ months following the exercise period .


A hierarchical linear model analysis indicated that the optimism intervention increased the pursuit of engagement-related happiness in the short term and reduced dysfunctional attitudes across follow-ups .


Pessimistic individuals had more to gain and reported fewer depressive symptoms at post-test .


These findings support the conclusion that empirically informed online interventions can improve psychological well-being , at least in the short run , and may be particularly helpful when tailored to the needs of the individual .


Despite their independent cardiovascular disease ( CVD ) advantages , effects of - linolenic acid ( ALA ) , monounsaturated fatty acid ( MUFA ) , and low-glycemic-load ( GL ) diets have not been assessed in combination .


We therefore determined the combined effect of ALA , MUFA , and low GL on glycemic control and CVD risk factors in type @ diabetes .


The study was a parallel design , randomized trial wherein each @-month treatment was conducted in a Canadian academic center between March @ and September @ and involved @ participants with type @ diabetes ( HbA@c @ % -@ % -LSB- @-@ mmol/mol -RSB- ) treated with oral antihyperglycemic agents .


Participants were provided with dietary advice on either a low-GL diet with ALA and MUFA given as a canola oil-enriched bread supplement ( @ g canola oil per @,@ kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) .


The primary outcome was HbA@c change .


Secondary outcomes included calculated Framingham CVD risk score and reactive hyperemia index ( RHI ) ratio .


Seventy-nine percent of the test group and @ % of the control group completed the trial .


The test diet reduction in HbA@c units of -@ % ( -@ mmol/mol ) ( @ % CI -@ % to -@ % -LSB- -@ to -@ mmol/mol -RSB- ) was greater than that for the control diet ( -@ % -LSB- -@ mmol/mol -RSB- -LSB- @ % CI -@ % to -@ % ( -@ to -@ mmol/mol ) -RSB- , P = @ ) , with the greatest benefit observed in those with higher systolic blood pressure ( SBP ) .


Greater reductions were seen in CVD risk score for the test diet , whereas the RHI ratio increased for the control diet .


A canola oil-enriched low-GL diet improved glycemic control in type @ diabetes , particularly in participants with raised SBP , whereas whole grains improved vascular reactivity .


Different types of exercises can help manage chronic neck pain .


Supervised exercise interventions are widely used , but these protocols require substantial resources .


The aim of this trial , which focused on adherence , was to evaluate two home exercise interventions .


This parallel group randomized controlled trial included @ women randomly allocated into two groups - a strength training group ( STRENGTH , @ subjects ) and a stretching group ( STRETCH , @ subjects ) .


The interventions focused on the neck and shoulder muscles and lasted for @ months .


The STRENGTH group performed weight training and ended each session with stretching exercises .


These stretching exercises constituted the entirety of the STRETCH group 's training session .


Both groups were instructed to exercise three times per week .


All the participants kept an exercise diary .


In addition , all participants were offered support via phone and e-mail .


The primary outcomes were pain intensity and function .


The trial included a four - to six-month and a twelve-month follow-up .


A completer in this study exercised at least @,@ times per week during eight unbroken weeks .


A responder in this study reported clinically significant improvements on pain and function .


The statistical analyses used the Mann Whitney U-test , Wilcoxon signed-rank test , and X@ test .


At four - to six-months , the numbers of completers were @ in the STRENGTH group and @ in the STRETCH group .


At twelve months , the corresponding numbers were @ ( STRENGTH ) and @ ( STRETCH ) .


At four - to six-months , the proportions of subjects reporting clinically important changes ( STRENGTH and STRETCH ) were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % .


At twelve months , the corresponding numbers were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % .