The mean effect on salt intake for intervention versus control group was -@ g/day ( @ % confidence interval -@ to -@ g/day ; P < @ ) in children and -@ g/day ( -@ to -@ g/day ; P < @ ) in adults .


The mean effect on systolic blood pressure was -@ mm Hg ( -@ to @ mm Hg ; P = @ ) in children and -@ mm Hg ( -@ to -@ mm Hg ; P < @ ) in adults .


An education programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families .


This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers.Trial registration ClinicalTrials.gov NCT@ .


Arthritis and musculoskeletal conditions are the leading cause of long-term work disability ( WD ) , an outcome with a major impact on quality of life and a high cost to society .


The importance of decreased at-work productivity has also recently been recognized .


Despite the importance of these problems , few interventions have been developed to reduce the impact of arthritis on employment .


We have developed a novel intervention called `` Making It Work '' , a program to help people with inflammatory arthritis ( IA ) deal with employment issues , prevent WD and improve at-work productivity .


After favorable results in a proof-of-concept study , we converted the program to a web-based format for broader dissemination and improved accessibility .


The objectives of this study are : @ ) to evaluate in a randomized controlled trial ( RCT ) the effectiveness of the program at preventing work cessation and improving at-work productivity ; @ ) to perform a cost-utility analysis of the intervention .


@ participants with IA will be recruited from British Columbia , Alberta , and Ontario in Canada .


The intervention consists of a ) @ online group sessions ; b ) @ web-based e-learning modules ; c ) consultations with an occupational therapist for an ergonomic work assessment and a vocational rehabilitation counselor .


Questionnaires will be administered online at baseline and every @months to collect information about demographics , disease measures , costs , work-related risk factors for WD , quality of life , and work outcomes .


Primary outcomes include at-work productivity and time to work cessation of > @months for any reason .


Secondary outcomes include temporary work cessation , number of days missed from work per year , reduction in hours worked per week , quality adjusted life year for the cost utility analysis , and changes from baseline in employment risk factors .


Analysis of Variance will evaluate the intervention 's effect on at-work productivity , and multivariable Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline .


This program fills an important gap in arthritis health services and addresses an important and costly problem .


Knowledge gained from the RCT will be useful to health care professionals , policy planners and arthritis stakeholders .


Closure of abdominal incisions with different suture materials has been a matter of great controversy .


Polypropylene and Polylactide with Polyglycolide are among the commonest suture materials used for closure of abdominal incisions .


Objectives of this study were to assess optimal suture material used for closure of elective abdominal incisions and to see complications associated with these suture materials .


This prospective , comparative , randomised study was conducted at public and private sector hospitals of Nawabshah and Hyderabad from @st Jan @ to @st October @ .


All patients who underwent abdominal surgery under the investigators ' supervision were included in the study .


Patients were divided into @ groups on even or odd numbers .


In group-A patients ' incision was closed with monofilament , non-absorbable Polypropylene ( Prolene ) No. @ suture material and in group-B incision was closed with Polyfilament , absorbable , co-polymer of Polylactide with Polyglycolide ( Vicryle ) No. @ .


A total @ patients were finally analysed for closure of elective abdominal incisions , with @ ( @ % ) patients in Group-A and @ ( @ % ) patients in Group-B .


Vicryle was found superior in knot security and suture handling .


Superficial wound infection was found in @ % patients of Group-A and @ % of Group-B .


Discharging sinus was found in @ % of Group-A vs @ % of Group-B .


Burst abdomen was seen in @ % patients in Group-A and @ % in Group-B .


Incisional hernia was present in @ % of Group-A and @ % patients of Group-B .


No patient in Group-B developed persistent pain at incisional site while it was found in @ % patients of Group-A .


Polylactide is an optimal suture material in closure of elective abdominal incisions .


Memantine , an uncompetitive N-methyl-d-aspartate receptor antagonist , is currently approved by the US Food and Drug Administration for the treatment of moderate to severe Alzheimer 's disease .


Anecdotal reports have suggested that memantine may improve neurologic and cognitive symptoms of individuals with the neurodegenerative disease fragile X-associated tremor/ataxia syndrome ( FXTAS ) ; however , its efficacy and safety in this population have not been assessed in a controlled trial .


Individuals with FXTAS aged @-@ years were enrolled in a randomized , double-blind , placebo-controlled , @-year trial between September @ and August @ .


Inclusion required definite , probable , or possible FXTAS in clinical stages @-@ according to previously published criteria .


Primary outcome measures were the Behavioral Dyscontrol Scale ( BDS ) score and CATSYS intention tremor severity .


Ninety-four participants were randomized from @ screened ; of those , @ and @ started treatment with memantine ( titrated to @ mg twice daily ) and placebo , respectively .


Thirty-four participants receiving memantine and @ receiving placebo completed the @-year endpoint assessment ( n = @ ) .


Intention-to-treat analysis showed no improvement with respect to intention tremor severity ( mean -LSB- SD -RSB- values with memantine vs placebo : @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , P = @ ) or BDS score ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , P = @ ) at follow-up .


Post hoc analyses of participants with early FXTAS ( stage @ ) , those with late FXTAS ( stage > @ ) , and those in different age groups ( @ years and > @ years ) also indicated no significant improvement .


More frequent mild adverse events were observed in the placebo group , while more frequent moderate adverse events occurred in the memantine group ( P = @ ) .


This randomized , double-blind , placebo-controlled trial of memantine for individuals with FXTAS showed no benefit compared to placebo with respect to the selected outcome measures .


Falling can lead to severe health issues in the elderly and importantly contributes to morbidity , death , immobility , hospitalization , and early entry to long-term care facilities .


The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas .


This study adopted an assessor-blinded , randomized , controlled trial methodology .


Subjects were enrolled in a @-week recurrent fall prevention program , which comprised strength training , balance training , and patient education .


Muscle strength and endurance of the ankles and the lower extremities , static balance , dynamic balance , depression , compliance with preventive behavior related to falls , fear of falling , and fall self-efficacy at baseline and immediately after the program were assessed .


Sixty-two subjects ( mean age @ years old ) completed the program -- @ subjects in the experimental group and @ subjects in the control group .


When the results of the program in the @ groups were compared , significant differences were found in ankle heel rise test , lower extremity heel rise test , dynamic balance , depression , compliance with fall preventative behavior , fear of falling , and fall self-efficacy ( p < @ ) , but no significant difference was found in static balance .


This study shows that the fall prevention program described effectively improves muscle strength and endurance , balance , and psychological aspects in elderly women with a fall history .


To study the diagnostic importance of a new Indis software package for the postprocessing of the results of radionuclude examinations ( Center for Information and Diagnostic Systems , St. Petersburg , Russia ) when analyzing the results of lacrimal scintigraphy .


Dynamic lacrimal scintigraphy was carried out in @ volunteers ( @ eyes ) and @ patients ( @ years ) with dacryostenosis .


The examined Indis program and the known Syngo program ( Siemens , Germany ) were used to calculate the elimination half-life of a radiopharmaceutical from the interest region corresponding to the whole ocular surface .


The time taken to postprocess the results of the examination was also determined .


When calculations were made using the Indis program and the Syngo system , the elimination half-lives of a tracer in the volunteers was @ @ and @ @ min , respectively .


These in the patents with dacryostenosis were @ @ and @ @ min .


With these programs , the times taken for postprocessing were @ @ and @ @ min , respectively .


The investigation showed the practical significance of the Indis software package in processing the data of lacrimal scintigraphy .


The calculations made with the Indis program correspond to those made with the known Syngo program .


The convenience and ergonomics of the program can precisely identify the region of interest .


The economic justification of the system is associated with the shorter time taken to postprocess and interpret the results of lacrimal scintigraphy .


The Indis software package may be recommended for use in the examination and treatment monitoring in patients with abnormal lacrimaton .


This study examined in - and post-treatment mediation effects of a @-session dose of Seeking Safety ( SS ) - an integrative cognitive behavioral treatment for comorbid PTSD and SUDs-on alcohol and cocaine outcomes in comparison to Women 's Health Education ( WHE ) in a seven-site randomized controlled effectiveness trial .


Women ( n = @ ) enrolled in outpatient substance abuse treatment , who had experienced multiple traumas in childhood and/or adulthood and who had comorbid PTSD , were randomly assigned to receive SS or WHE delivered in open enrollment groups for @ sessions in @ weeks ( unlike the full @-topic SS protocol ) .


Data were analyzed under two forms of longitudinal mediation analysis , each accounting for changes over time in group membership and group context , respectively .


Women in SS , compared to WHE , showed significantly steeper decreases in PTSD frequency and severity , which in turn , showed significant impact in reducing both cocaine and alcohol use .


This pattern was strongest for those who completed most of the treatment sessions , which was the majority of patients in the trial ; these patterns only emerged during the in-treatment phase .


Use of an integrated approach to PTSD/SUD such as SS can be helpful to more rapidly reduce PTSD , which consequently reduce SUD symptoms , particularly for those who attend most of the available treatment sessions .


This is one of the first studies to illustrate such effects in treating comorbid PTSD and SUD in the context of a highly impaired population delivered by community-based providers .


( Am J Addict @ ; @:@ -@ ) .


Ivabradine is a negative chronotropic drug with minimal effects on central hemodynamics .


Its effect on dynamic obstruction of the left ventricular outflow tract ( LVOT ) in cats with hypertrophic cardiomyopathy ( HCM ) remains unknown .


Ivabradine reduces dynamic obstruction of the LVOT in cats with HCM .


Twenty-eight client-owned cats with preclinical HCM and dynamic LVOT obstruction .


Randomized , double-blind , active-control single dose study .


Cats received a single dose of either ivabradine ( @ mg/kg PO ) or atenolol ( @ mg/kg PO ) .


Heart rate , echocardiographic variables , and systolic blood pressure ( SBP ) were recorded before and @ hours after drug administration .


Statistical comparisons were made using ANCOVA .


Peak velocity in the LVOT was significantly decreased compared to baseline for both drugs ; however , the effect was more prominent with atenolol ( mean reduction @ m/s ; @ % CI @-@ @ m/s ) compared to ivabradine ( mean reduction @ m/s ; @ % CI -@ to @ m/s ; P < @ ) .


Echocardiographic indices of systolic function were largely unchanged by ivabradine , but significantly reduced by atenolol .


A single dose of ivabradine decreases dynamic LVOT obstruction in cats with HCM , but the clinical effect is negligible and inferior compared to that achieved by atenolol .


Age-related macular degeneration ( AMD ) is the leading cause of blindness among older adults in the developed world .


The only treatments currently available , such as ranibizumab injections , are for neovascular AMD , which accounts for only @ to @ % of people with the condition .


Hypoxia has been implicated as one of the primary causes of AMD , and is most acute at night when the retina is most metabolically active .


By increasing light levels at night , the metabolic requirements of the retina and hence the hypoxia will be considerably reduced .


This trial seeks to determine whether wearing a light mask that emits a dim , green light during the night can prevent the progression of early AMD .


ALight is a Phase I/IIa , multicentre , randomized controlled trial .


Sixty participants ( @ to @years old ) with early AMD in one eye and neovascular AMD ( nAMD ) in the fellow eye will be recruited from nAMD clinics .


They will be randomized ( in the ratio @:@ ) , either to receive the intervention or to be in the untreated control group , stratified according to risk of disease progression .


An additional @ participants with healthy retinal appearance , or early AMD only , will be recruited for a baseline cross-sectional analysis .


The intervention is an eye mask that emits a dim green light to illuminate the retina through closed eyelids at night .


This is designed to reduce the metabolic activity of the retina , thereby reducing the potential risk of hypoxia .


Participants will wear the mask every night for @months .


Ophthalmologists carrying out monthly assessments will be masked to the treatment group , but participants will be aware of their treatment group .


The primary outcome measure is the proportion of people who show disease progression during the trial period in the eye with early AMD .


A co-primary outcome measure is the rate of retinal adaptation .


As this is a trial of a CE-marked device for an off-label indication , a further main aim of this trial is to assess safety of the mask in the cohort of participants with AMD .


Erythropoietic protoporphyria is a severe photodermatosis that is associated with acute phototoxicity .


Patients with this condition have excruciating pain and a markedly reduced quality of life .


We evaluated the safety and efficacy of an - melanocyte-stimulating hormone analogue , afamelanotide , to decrease pain and improve quality of life .


We conducted two multicenter , randomized , double-blind , placebo-controlled trials of subcutaneous implants containing @ mg of afamelanotide .


Patients in the European Union ( @ patients ) and the United States ( @ patients ) were randomly assigned , in a @:@ ratio , to receive a subcutaneous implant containing either afamelanotide or placebo every @ days ( a total of five implants in the European Union study and three in the U.S study ) .


The type and duration of sun exposure , number and severity of phototoxic reactions , and adverse events were recorded over the respective @-day and @-day study periods .


Quality of life was assessed with the use of validated questionnaires .


A subgroup of U.S. patients underwent photoprovocation testing .


The primary efficacy end point was the number of hours of direct exposure to sunlight without pain .


In the U.S. study , the duration of pain-free time after @ months was longer in the afamelanotide group ( median , @ hours , vs. @ hours in the placebo group ; P = @ ) .


In the European Union study , the duration of pain-free time after @ months was also longer in the afamelanotide group than in the placebo group ( median , @ hours vs. @ hours ; P = @ ) , and the number of phototoxic reactions was lower in the the afamelanotide group ( @ vs. @ , P = @ ) .


In both trials , quality of life improved with afamelanotide therapy .


Adverse events were mostly mild ; serious adverse events were not thought to be related to the study drug .


Afamelanotide had an acceptable side-effect and adverse-event profile and was associated with an increased duration of sun exposure without pain and improved quality of life in patients with erythropoietic protoporphyria .


( Funded by Clinuvel Pharmaceuticals and others ; ClinicalTrials.gov numbers , NCT@ and NCT@ . )


Mild head injuries commonly present to emergency departments .


The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury , and which patients can safely be sent home .


Traumatic brain injuries may exist with subtle symptoms or signs , but can still lead to adverse outcomes .


Despite the existence of several high quality clinical practice guidelines , internationally and in Australia , research shows inconsistent implementation of these recommendations .


The aim of this trial is to test the effectiveness of a targeted , theory - and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients ( @years of age or older ) who present following mild head injuries ( concussion ) , compared with passive dissemination of these recommendations .


The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed .


The design of this study is a cluster randomised trial .


We aim to include @ Australian @-hour emergency departments , which will be randomised to an intervention or control group .


Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries .


The intervention group will receive an implementation intervention based on an analysis of influencing factors , which include local stakeholder meetings , identification of nursing and medical opinion leaders in each site , a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a @month period of time .


Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the @month period following intervention delivery ( patient level outcomes ) .


In consenting hospitals , eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers .


A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted .


Sample size calculations are based on including @ patients on average per department .


Outcome assessors will be blinded to group allocation .


The population of obese patients is progressively growing and bariatric operations are becoming increasingly common .


Morbidly obese patients require special anesthetic care and are often considered to be difficult to ventilate and intubate .


The VivaSight Single Lumen tube is an endotracheal tube with a camera embedded in its tip .


The view from the tip appears continuously on a monitor in the anesthesiologist 's vicinity .


The aim of this study was to assess the VivaSight in comparison with conventional endotracheal tube as an aid in the intubation and surveillance of tube position during surgery of obese patients .


This is a prospective study of @ adult obese patients who underwent laparoscopic sleeve gastrectomy .


The patients were randomly assigned to be intubated by either the VivaSight ( @ patients , test group ) or a conventional endotracheal tube ( @ patients , control group ) .


Data on the patients , the pre-operative airway evaluation , the endotracheal intubation and the post-operative outcome were collected and compared .


The Mallampati scores were significantly higher in the test group than in the control group .


Endotracheal intubation took @ and @seconds using the VivaSight and a conventional tube respectively ( p = @ ) .


Three of the patients in the control group , while none of those in the test group , had soft tissue injury ( p < @ ) .


We found the VivaSight SL to be helpful in the endotracheal intubation and continuous surveillance of tube position in morbidly obese patients undergoing laparoscopic sleeve gastrectomy .


Non-small-cell lung cancer ( NSCLC ) with a mutation in the gene encoding epidermal growth factor receptor ( EGFR ) is sensitive to approved EGFR inhibitors , but resistance develops , mediated by the T@M EGFR mutation in most cases .


Rociletinib ( CO-@ ) is an EGFR inhibitor active in preclinical models of EGFR-mutated NSCLC with or without T@M .


In this phase @-@ study , we administered rociletinib to patients with EGFR-mutated NSCLC who had disease progression during previous treatment with an existing EGFR inhibitor .


In the expansion ( phase @ ) part of the study , patients with T@M-positive disease received rociletinib at a dose of @ mg twice daily , @ mg twice daily , or @ mg twice daily .


Key objectives were assessment of safety , side-effect profile , pharmacokinetics , and preliminary antitumor activity of rociletinib .


Tumor biopsies to identify T@M were performed during screening .


Treatment was administered in continuous @-day cycles .


A total of @ patients were enrolled .


The first @ patients to be enrolled received the free-base form of rociletinib ( @ mg once daily to @ mg twice daily ) .


The remaining patients received the hydrogen bromide salt ( HBr ) form ( @ mg twice daily to @ mg twice daily ) .


A maximum tolerated dose ( the highest dose associated with a rate of dose-limiting toxic effects of less than @ % ) was not identified .


The only common dose-limiting adverse event was hyperglycemia .


In an efficacy analysis that included patients who received free-base rociletinib at a dose of @ mg twice daily or the HBr form at any dose , the objective response rate among the @ patients with T@M-positive disease who could be evaluated was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) , and the rate among the @ patients with T@M-negative disease who could be evaluated was @ % ( @ % CI , @ to @ ) .


Rociletinib was active in patients with EGFR-mutated NSCLC associated with the T@M resistance mutation .


( Funded by Clovis Oncology ; ClinicalTrials.gov number , NCT@ . )


Although pain in knee osteoarthritis ( OA ) commonly affects activity engagement , the daily pain experience has not been fully characterized .


Specifically , the nature and impact of pain flares is not well understood .


This study characterized pain flares as defined by participants with knee OA .


Pain flare occurrence and experience were measured over @ days .


This was a multiple methods study ; qualitative methods were dominant .


Data were collected during the baseline portion of a randomized controlled trial .


Participants met criteria for knee OA and had moderate to severe pain .


They completed questionnaires and a @-day home monitoring period that captured momentary symptom reports simultaneously with physical activity via accelerometry ( n = @ ) .


Participants also provided individual definitions of pain flare that were used throughout the home monitoring period to indicate whether a pain flare occurred .


Pain flares were described most often by quality ( often sharp ) , followed by timing ( seconds , minutes ) and by antecedents and consequences .


When asked if their definition of a flare agreed with a supplied definition , @ % of the sample reported only `` somewhat , '' `` a little , '' or `` not at all . ''


Using individual definitions , @ % experienced at least @ daily pain flare over the home monitoring period ; @ % had a flare on more than @ % of the monitored days .


Pain flares were common , fleeting , and often experienced in the context of activity engagement .


Participants ' views on what constitutes a pain flare differ from commonly accepted definitions .


Pain flares are an understudied aspect of the knee OA pain experience and require further characterization .


Gestational diabetes mellitus ( GDM ) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child .


Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes .


However , there are no randomized controlled trials ( RCT ) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes .


An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira ( IMIP ) , Brazil .


A total of @ pregnant women will be studied ; @ gestational diabetics will undergo an aquatic physical exercise program in a thermal pool , @ times per week over @ months .


The primary endpoint will be glucose level control and use of insulin ; secondary endpoints will be the following maternal and fetal outcomes : weight gain during pregnancy , blood pressure , pre-eclampsia diagnosis , intrauterus growth restriction , preterm birth , Cesarean section , macrosomia and maternal or neonatal intensive care admission .


Endpoints between intervention and control group will analyzed by t test for unpaired data and test , and the level of significance will set at < @ .


The physical proprieties of water make aquatic exercises ideal for pregnant women .


An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance .


It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control .


To compare the long-term efficacy of a corneal limbal conjunctival autograft combined with pterygium excision in the treatment of primary pterygium .


This random control study included @ patients ( @ eyes ) with primary pterygium .


These were randomly divided into a group with corneal limbal conjunctival autograft combined with pterygium excision ( group A ) and a group with pterygium excision with exposed sclera ( group B ) and subjected to long-term follow up .


The surgical outcomes were classified and evaluated ( grade I-IV ) .


Several indexes were analyzed , including ocular surface irritation symptom , tear film stability , surgical complication , and recurrence rate .


The follow up ranged from @ to @ months , ( @ + / -@ ) months on average .


No recurrence was noted at @ weeks postoperatively .


At @ months postoperatively , the recurrence rate of pterygium was @ % in group A and @ % in group B.


At @ year postoperatively , the recurrence rate in group A was @ % and @ % in group B.


At the end of follow up , the recurrence rates were @ % in group A and @ % in group B. No statistical significance was found between two groups regarding the recurrence rates at each time point ( P > @ ) .


After the follow up ( > @ years ) , the severity of ocular surface conditions was significantly milder in patients in group A than in group B ( P < @ ) .


No statistically significant differences were noted between the two groups at @ weeks , @ months , and @ year after surgery .


No statistically significant differences were observed between the two groups regarding postoperative tear film break-up time .


Fewer postoperative complications and milder ocular surface irritation symptoms occurred in patients in group A.


Corneal limbal conjunctival autograft combined with pterygium excision yields sound long-term efficacy and a low recurrence rate and induces only mild damage on the ocular surface when used as a treatment for pterygium .


Young adulthood ( age @ to @ ) is a high-risk period for unhealthy weight gain .


Few studies have recruited for prevention of weight gain , particularly in young adults .


This paper describes the recruitment protocol used in the Study of Novel Approaches to Prevention ( SNAP ) .


We conducted extensive formative work to inform recruitment methods and message development .


We worked with a professional marketing firm to synthesize major themes and subsequently develop age-appropriate messages for recruitment .


A variety of approaches and channels were used across two clinical centers to recruit young adults who were normal or overweight ( body mass index ( BMI ) @ to @kg/m@ ) for a @-year intervention designed to prevent weight gain .


We tracked recruitment methods , yields , and costs by method .


Logistic regression was used to identify recruitment methods that had the highest relative yield for subgroups of interest with covariate adjustments for clinic .


The final sample of @ participants ( @ % minority , @ % male ) was recruited over a @-month period of sustained efforts .


About @ % of those who initially expressed interest via a screening website were randomized .


The most common reason for ineligibility was already being obese ( BMI > @kg/m@ ) .


The top two methods for recruitment were mass mailing followed by email ; together they were cited by @ % of those recruited .


Television , radio , paid print advertising , flyers and community events each yielded fewer than @ % of study participants .


Email was the most cost-effective method per study participant recruited .


These findings can guide future efforts to recruit young adults and for trials targeting weight gain prevention .


To evaluate immune responses in fingolimod-treated patients with multiple sclerosis ( MS ) against influenza vaccine ( to test for responses against anticipated novel antigens in seronegative patients ) and recall ( tetanus toxoid -LSB- TT -RSB- booster dose ) antigens .


This was a blinded , randomized , multicenter , placebo-controlled study .


Patients aged @ to @ years with relapsing MS were randomized ( @:@ ) to fingolimod @ mg or placebo for @ weeks .


At week @ , patients received seasonal influenza vaccine ( containing antigens of California , Perth , and Brisbane virus strains ) and TT booster dose .


Antibody titers against influenza and TT were estimated at baseline ( prevaccination ) and @ and @ weeks postvaccination .


The primary efficacy variable was responder rate ( proportion of patients showing seroconversion or significant increase -LSB- @-fold -RSB- in antibody titers against at least one influenza virus strain ) at @ weeks postvaccination and vs placebo .


Of @ randomized patients ( fingolimod @ , placebo @ ) , @ completed the study ( @ discontinued in fingolimod group ) .


The responder rates ( odds ratio ; @ % confidence interval ) for influenza vaccine ( fingolimod vs placebo ) were @ % vs @ % ( @ ; @-@ @ ) at @ weeks and @ % vs @ % ( @ ; @-@ @ ) at @ weeks postvaccination .


For TT , responder rates were @ % vs @ % ( @ ; @-@ @ ) at @ weeks and @ % vs @ % ( @ ; @-@ @ ) at @ weeks postvaccination .


Adverse events were reported in @ % and @ % of patients receiving fingolimod and placebo , respectively .


Most fingolimod-treated patients with MS were able to mount immune responses against novel and recall antigens and the majority met regulatory criteria indicating seroprotection .


However , response rates were reduced compared with placebo-treated patients .


This should be kept in mind when vaccinating patients on fingolimod .


This study provides Class I evidence that in some patients with MS receiving immunizations , concurrent fingolimod treatment in comparison to placebo decreases vaccination-induced immune responses .


New femtosecond laser platforms may reduce ocular surface interference and LASIK-associated dry eye .


This study investigated tear protein profiles in subjects who underwent LASIK using two femtosecond lasers to assess differences in protein expression .


This was a randomized interventional clinical trial involving @ patients who underwent femtosecond laser refractive surgery with a contralateral paired eye design .


Corneal flaps of @ subjects were created by either Visumax or Intralase laser .


Tear samples were collected preoperatively , and at @ week and @ months postoperatively using Schirmer 's strips .


Tear protein ratios were calculated relative to preoperative protein levels at baseline .


The main outcome measures were the levels of a panel of dry eye protein markers analyzed using isobaric tagging for relative and absolute quantitation ( iTRAQ ) mass spectrometry .


A total of @ unique proteins were quantifiable .


Tear protein ratios were differentially regulated between the eyes treated with different lasers .


The secretoglobulins Lipophilin A ( @-fold ) and Lipophilin C ( @ ) were significantly upregulated ( P < @ ) at @ week postoperatively in Visumax but not in Intralase-treated eyes .


At @ week , orosomucoid@ was upregulated ( @ ) in Intralase but not Visumax-treated eyes .


In the same eyes , lysozyme , cathepsin B , and lipo-oxygenase were downregulated at @ - , @ - , and @-folds , respectively .


Transglutaminase-@ was downregulated in both groups of eyes .


Different laser platforms induce distinct biological responses in the cornea and ocular surface , which manifests as different levels of tear proteins .


This study has implications for surgical technology and modulation of wound healing responses .


( ClinicalTrials.gov number , NCT@ . )


To determine if atomoxetine would improve attention impairment following traumatic brain injury ( TBI ) .


Outpatients from a free-standing , private , not-for-profit rehabilitation hospital .


Fifty-five adult participants with a history of a single moderate-to-severe TBI , who were at least @ year from injury and with self-reported complaints of attention difficulties .


Atomoxetine , a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at @mg twice a day for @ weeks , compared to placebo .


Randomized double-blind placebo controlled trial , with placebo run-in .


Cognitive Drug Research ( CDR ) , Computerized Cognitive Assessment System , Stroop Color and Word Test , Adult ADHD Self-Report Scale ( ASRS-v@ @ ) , Neurobehavioural Functioning Inventory ( NFI ) .


Atomoxetine was well-tolerated by the subject sample .


The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention , the CDR Power of Attention domain or the Stroop Interference score .


In addition , no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression .


Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention .


This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI .


Various possibilities are discussed , including the need for a more sophisticated system of classification of TBI .


To assess the efficacy and safety of enzyme replacement therapy ( ERT ) with BMN @ ( elosulfase alfa ) in patients with Morquio A syndrome ( mucopolysaccharidosis IVA ) .


Patients with Morquio A aged @years ( N = @ ) were randomised ( @:@:@ ) to receive elosulfase alfa @ mg/kg/every other week ( qow ) , elosulfase alfa @ mg/kg/week ( weekly ) or placebo for @weeks in this phase @ , double-blind , randomised study .


The primary efficacy measure was @-min walk test ( @MWT ) distance .


Secondary efficacy measures were @-min stair climb test ( @MSCT ) followed by change in urine keratan sulfate ( KS ) .


Various exploratory measures included respiratory function tests .


Patient safety was also evaluated .


At week @ , the estimated mean effect on the @MWT versus placebo was @ m ( @ % CI @ , @ ; P = @ ) for weekly and @ m ( @ % CI -@ , @ ; P = @ ) for qow .


The estimated mean effect on @MSCT was @ stairs/min ( @ % CI -@ , @ ; P = @ ) for weekly and -@ stairs/min ( @ % CI -@ , @ ; P = @ ) for qow .


Normalised urine KS was reduced at @weeks in both regimens .


In the weekly dose group , @ % of patients had adverse events leading to an infusion interruption/discontinuation requiring medical intervention ( only @ % of all infusions in this group ) over @months .


No adverse events led to permanent treatment discontinuation .


Elosulfase alfa improved endurance as measured by the @MWT in the weekly but not qow dose group , did not improve endurance on the @MSCT , reduced urine KS , and had an acceptable safety profile .


The availability of less resource-intensive alternatives to home visits for rehabilitation following orthopaedic surgeries is important , given the increasing need for home care services and the shortage of health resources .


The goal of this trial was to determine whether an in-home telerehabilitation program is not clinically inferior to a face-to-face home visit approach ( standard care ) after hospital discharge of patients following a total knee arthroplasty .


Two hundred and five patients who had a total knee arthroplasty were randomized before hospital discharge to the telerehabilitation group or the face-to-face home visit group .


Both groups received the same rehabilitation intervention for two months after hospital discharge .


Patients were evaluated at baseline ( before total knee arthroplasty ) , immediately after the rehabilitation intervention ( two months after discharge ) , and two months later ( four months after discharge ) .


The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) questionnaire at the last follow-up evaluation .


Secondary outcome measures included the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire , functional and strength tests , and knee range of motion .


The noninferiority margin was set at @ % for the WOMAC .


The demographic and clinical characteristics of the two groups of patients were similar at baseline .


At the last follow-up evaluation , the mean differences between the groups with regard to the WOMAC gains , adjusted for baseline values , were near zero ( for @ patients in the per-protocol analysis ) : -@ % ( @ % confidence interval -LSB- CI -RSB- : -@ % , @ % ) for the total score , -@ % ( @ % CI : -@ % , @ % ) for pain , -@ % ( @ % CI : -@ % , @ % ) for stiffness , and -@ % ( @ % CI : -@ % , @ % ) for function .


The confidence intervals were all within the predetermined zone of noninferiority .


The secondary outcomes had similar results , as did the intention-to-treat analysis , which was conducted afterward for @ patients .


Our results demonstrated the noninferiority of in-home telerehabilitation and support its use as an effective alternative to face-to-face service delivery after hospital discharge of patients following a total knee arthroplasty .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia .


We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control .


We did this open-label , multicentre , randomised controlled , crossover study between Dec @ , @ , and Dec @ , @ , recruiting patients from three centres in the UK .


Patients aged @ years or older with type @ diabetes were randomly assigned to receive @ weeks of overnight closed-loop insulin delivery ( using a model-predictive control algorithm to direct insulin delivery ) , then @ weeks of insulin pump therapy ( in which participants used real-time display of continuous glucose monitoring independent of their pumps as control ) , or vice versa .


Allocation to initial treatment group was by computer-generated permuted block randomisation .


Each treatment period was separated by a @-@ week washout period .


The primary outcome was time spent in the target glucose range of @-@ mmol/L between @ h and @ h. Analyses were by intention to treat .


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


We randomly assigned @ participants to initial treatment in either the closed-loop group or the control group , patients were later crossed over into the other group ; one patient from the closed-loop group withdrew consent after randomisation , and data for @ patients were analysed .


Closed loop was used over a median of @ h ( IQR @-@ ) on @ ( @ % ) of @ nights .


The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period ( mean difference between groups @ % , @ % CI @-@ ; p = @ ) .


We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period ; these episodes were not related to closed-loop algorithm instructions .


Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type @ diabetes .


Advanced colorectal cancer is treated with a combination of cytotoxic drugs and targeted treatments .


However , how best to minimise the time spent taking cytotoxic drugs and whether molecular selection can refine this further is unknown .


The primary aim of this study was to establish how cetuximab might be safely and effectively added to intermittent chemotherapy .


COIN-B was an open-label , multicentre , randomised , exploratory phase @ trial done at @ hospitals in the UK and one in Cyprus .


We enrolled patients with advanced colorectal cancer who had received no previous chemotherapy for metastases .


Randomisation was done centrally ( by telephone ) by the Medical Research Council Clinical Trials Unit using minimisation with a random element .


Treatment allocation was not masked .


Patients were assigned ( @:@ ) to intermittent chemotherapy plus intermittent cetuximab or to intermittent chemotherapy plus continuous cetuximab .


Chemotherapy was FOLFOX ( folinic acid and oxaliplatin followed by bolus and infused fluorouracil ) .


Patients in both groups received FOLFOX and weekly cetuximab for @ weeks , then either had a planned interruption ( those taking intermittent cetuximab ) or planned maintenance by continuing on weekly cetuximab ( continuous cetuximab ) .


On RECIST progression , FOLFOX plus cetuximab or FOLFOX was recommenced for @ weeks followed by further interruption or maintenance cetuximab , respectively .


The primary outcome was failure-free survival at @ months .


The primary analysis population consisted of patients who completed @ weeks of treatment without progression , death , or leaving the trial .


We tested BRAF and NRAS status retrospectively .


The trial was registered , ISRCTN@ .


We registered @ patients , @ of whom were enrolled .


Results for @ with KRAS wild-type are reported here , @ ( @ % ) assigned to intermittent cetuximab and @ ( @ % ) to continuous cetuximab .


@ patients assigned to intermittent cetuximab and @ of those assigned to continuous cetuximab were included in the primary analysis .


@-month failure-free survival was @ % ( lower bound of @ % CI @ ) in the intermittent group versus @ % ( lower bound of @ % CI @ ) in the continuous group ; median failure-free survival was @ months ( @ % CI @-@ @ ) and @ months ( @-@ @ ) , respectively .


The most common grade @-@ adverse events were skin rash ( @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ patients ) , neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , diarrhoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and lethargy ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Cetuximab was safely incorporated in two first-line intermittent chemotherapy strategies .


Maintenance of biological monotherapy , with less cytotoxic chemotherapy within the first @ months , in molecularly selected patients is promising and should be validated in phase @ trials .


Myocardial infarction is the leading cause of death in fire fighters and has been linked with exposure to air pollution and fire suppression duties .


We therefore investigated the effects of wood smoke exposure on vascular vasomotor and fibrinolytic function , and thrombus formation in healthy fire fighters .


In a double-blind randomized cross-over study , @ healthy male fire fighters were exposed to wood smoke ( ~ @ mg/m particulate matter concentration ) or filtered air for one hour during intermittent exercise .


Arterial pressure and stiffness were measured before and immediately after exposure , and forearm blood flow was measured during intra-brachial infusion of endothelium-dependent and - independent vasodilators @-@ hours after exposure .


Thrombus formation was assessed using the ex vivo Badimon chamber at @ hours , and platelet activation was measured using flow cytometry for up to @ hours after the exposure .


Compared to filtered air , exposure to wood smoke increased blood carboxyhaemoglobin concentrations ( @ % versus @ % ; P < @ ) , but had no effect on arterial pressure , augmentation index or pulse wave velocity ( P > @ for all ) .


Whilst there was a dose-dependent increase in forearm blood flow with each vasodilator ( P < @ for all ) , there were no differences in blood flow responses to acetylcholine , sodium nitroprusside or verapamil between exposures ( P > @ for all ) .


Following exposure to wood smoke , vasodilatation to bradykinin increased ( P = @ ) , but there was no effect on bradykinin-induced tissue-plasminogen activator release , thrombus area or markers of platelet activation ( P > @ for all ) .


Wood smoke exposure does not impair vascular vasomotor or fibrinolytic function , or increase thrombus formation in fire fighters .


Acute cardiovascular events following fire suppression may be precipitated by exposure to other air pollutants or through other mechanisms , such as strenuous physical exertion and dehydration .


The New Nordic Diet ( NND ) has induced weight loss in a @-week controlled intervention .


We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects .


After @ weeks of intervention with NND or Average Danish Diet ( ADD ) , @ participants ( mean age @ years and mean BMI @ kg/m ) were followed for further @ weeks .


All participants were encouraged to follow NND but without further guidance .


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


One hundred and ten participants ( @ % ) completed the follow-up .


Among participants previously randomised to NND ( NND group ) , dietary compliance and satisfaction decreased from @ to @ and from @ to @ , respectively ( both p < @ ) ( @-@ point scale ) .


Among those originally randomised to ADD ( ADD group ) , satisfaction with NND was significantly higher than with ADD during follow-up ( @ vs. @ , p = @ ) .


Weight losses during intervention of -@ kg and -@ kg were followed by regains of @ kg ( SE @ ) and @ kg ( SE @ ) for the NND group and ADD group , respectively -LSB- adjusted difference ; mean ( @ % CI ) : @ kg ( @-@ @ ) , p = @ -RSB- .


Across diet groups , every @ score higher in compliance with NND was associated with @ kg less body weight regain ( p = @ ) and those who increased physical activity regained @ kg less compared to those who did not ( p < @ ) .


NND provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity .


Advanced pancreatic cancer ( APC ) , beside its high mortality , causes the highest rates of venous thromboembolic events ( VTE ) .


Enoxaparin , a low molecular weight heparin ( LMWH ) , is effective in prevention and treatment of VTE .


Some small studies indicated that this benefit might extend to patients with cancer and probably prolong survival due to independent mechanisms .


We initiated this safety investigation to get feasibility information on intensified chemotherapy combined with LMWH in outpatients with APC treated in @st line .


The trial was a prospective , open-label , single center investigation in outpatients with inoperable pancreatic cancer who were treated with intensified first-line chemotherapy along with concomitant application of subcutaneous LMWH .


The combined chemotherapy consisted of gemcitabine @ g/m@ ( @ min ) , @-FU @ mg/m@ ( @ h ) , folinic acid @ mg/m@ ( @ min ) , and Cisplatin @ mg/m@ ( @ min ) on day @ and @ ; q@w for the first @ weeks ( GFFC ) followed by gemcitabine alone in patients without cancer progression .


The simultaneous application of prophylactic enoxaparin started on day @ of chemotherapy with a fixed dose of @ mg daily .


Statistical analyses were performed using R @ with software package CMPRSK and SPSS software v@ @ .


The investigation was stopped after recruitment of @ patients .


At this time @ patients had completed the required @ weeks of treatment .


Based on @ cycles of GFFC + enoxaparin ( median @/pt -LSB- range : @-@ -RSB- ) and @ cycles of single-agent gemcitabine + enoxaparin ( median @/pt -LSB- range : @-@ -RSB- ) the cumulative frequency of NCI-CTC toxicities grade @/@ was below @ % .


One case ( @ % ) of a symptomatic non-lethal thromboembolic event was observed while receiving LMWH treatment .


No severe bleeding event as defined in the protocol has been observed .


The median overall survival was @ -LSB- @ % CI : @-@ @ -RSB- months .


The addition of enoxaparin to GFFC chemotherapy is feasible , safe and does not appear to affect the efficacy or the toxicity profile of the chemotherapy regimen in patients with advanced pancreatic adenocarcinoma .


Based on these findings we have initiated the randomized CONKO-@ trial to examine whether enoxaparin reduces the incidence of thromboembolic events or increases overall outcome .


Vorapaxar reduces cardiovascular death , myocardial infarction ( MI ) , or stroke in patients with previous MI while increasing bleeding .


Patients with diabetes mellitus ( DM ) are at high risk of recurrent thrombotic events despite standard therapy and may derive particular benefit from antithrombotic therapies .


The Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-TIMI @ trial was a randomized , double-blind , placebo-controlled trial of vorapaxar in patients with stable atherosclerosis .


We examined the efficacy of vorapaxar in patients with and without DM who qualified for the trial with a previous MI .


Because vorapaxar is contraindicated in patients with a history of stroke or transient ischemic attack , the analysis ( n = @ @ ) excluded such patients .


The primary end point of cardiovascular death , MI , or stroke occurred more frequently in patients with DM than in patients without DM ( rates in placebo group : @ % versus @ % ; adjusted hazard ratio , @ ; P < @ ) .


In patients with DM ( n = @ ) , vorapaxar significantly reduced the primary end point ( @ % versus @ % ; hazard ratio , @ -LSB- @ % confidence interval , @-@ @ -RSB- ; P = @ ) with a number needed to treat to avoid @ major cardiovascular event of @ .


The incidence of moderate/severe bleeding was increased with vorapaxar in patients with DM ( @ % versus @ % ; hazard ratio , @ -LSB- @ % confidence interval , @-@ @ -RSB- ) .


However , net clinical outcome integrating these @ end points ( efficacy and safety ) was improved with vorapaxar ( hazard ratio , @ -LSB- @ % confidence interval , @-@ @ -RSB- ) .


In patients with previous MI and DM , the addition of vorapaxar to standard therapy significantly reduced the risk of major vascular events with greater potential for absolute benefit in this group at high risk of recurrent ischemic events .


To assess the efficacy and safety of eslicarbazepine acetate ( ESL ) as monotherapy in North American patients with partial-onset seizures ( POS ) .


This multicenter , randomized , double-blind `` withdrawal to monotherapy '' study used historical control data as the comparator .


Adults with POS medically uncontrolled by one to two antiepileptic drugs gradually converted to ESL monotherapy .


Following an @-week baseline period , patients were randomized @:@ to receive ESL @,@ mg ( n = @ ) or @,@ mg QD ( n = @ ) for @ weeks .


The primary end point was the proportion of patients meeting predefined exit criteria ( signifying worsening seizure control ) .


Treatment was considered effective if the @ % upper confidence limit ( UCL ) for the Kaplan-Meier estimated exit rate was lower than the exit rate threshold calculated from the historical control ( @ % ) .


Kaplan-Meier estimated exit rates were : ESL @,@ mg , @ % ( @ % CI @-@ @ % ) and @,@ mg , @ % ( @-@ @ % ) .


The difference between doses was not significant ( p = @ ) .


For both doses , the @ % UCLs for the exit rate were @ % ; ESL monotherapy was considered superior to the historical control .


There was no statistically significant increase in the risk of study exit related to carbamazepine use .


Nine ( @ % ) and five patients ( @ % ) remained seizure-free during the @-week monotherapy period , while taking ESL @,@ and @,@ mg , respectively .


The reductions in median standardized seizure frequency ( seizures per @ days ) between baseline and the @-week treatment period were : ESL @,@ mg , @ % and @,@ mg , @ % .


Treatment-emergent adverse events ( TEAEs ) occurring in @ % of patients were dizziness , headache , fatigue , somnolence , nausea , and nasopharyngitis .


The TEAE most frequently leading to discontinuation was hyponatremia ( @ % ) .


ESL was efficacious and well tolerated as monotherapy in North American patients , and led to a reduction in seizure frequency .


Exit rates for ESL @,@ and @,@ mg QD were superior to the historical control ; the difference in exit rates between doses was not statistically significant .


Interleukin @ ( IL-@ ) is thought to play a key role as an effector cytokine in UC .


Anrukinzumab , a humanised antibody that inhibits human IL-@ , was evaluated for the treatment of UC .


In a multicentre , randomised , double-blind , placebo-controlled study , patients with active UC ( Mayo score @ and < @ ) were randomised to anrukinzumab @ , @ or @mg or placebo .


Patients received five intravenous administrations over @weeks .


The primary endpoint was fold change from baseline in faecal calprotectin ( FC ) at Week @ .


Secondary endpoints included safety , pharmacokinetics and IL-@ levels .


The modified intention-to-treat population included @ patients ( @ patients/arm ) .


Fold change of FC from baseline at Week @ was not significantly different for any treatment groups compared with the placebo .


The study had a high dropout rate , in part , related to lack of efficacy .


The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score , clinical response , clinical remission and proportion of subjects with mucosal healing .


An increase in serum total IL-@ ( free and bound to anrukinzumab ) was observed for all anrukinzumab groups but not with placebo .


This suggests significant binding of anrukinzumab to IL-@ .


The safety profile was not different between the anrukinzumab and placebo groups .


A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-@ .


To investigate the changes in adrenocorticotropic hormone ( ACTH ) and cortisol in heroin addicts given Jitai tablet treatment during abstinence .


Double-blind , randomized , placebo-controlled clinical trial .


Drug Rehabilitation Bureau of Shanghai Police , China .


@ volunteers , including @ heroin addicts and @ healthy volunteers .


@ heroin addicts randomly divided into two groups : the Jitai tablet group , which comprised @ heroin addicts given Jitai tablet treatment during abstinence , and the placebo group , which comprised @ heroin addicts given placebo .


A control group consisted of @ sex - and age-matched healthy volunteers .


ACTH and cortisol in plasma were measured in all groups at baseline and in the Jitai tablet and placebo groups on the third , seventh , and @th days of abstinence .


Levels of both ACTH ( p < @ ) and cortisol ( p < @ ) were significantly higher in heroin addicts at baseline than in the healthy volunteers .


Jitai tablet treatment restored plasma cortisol levels to normal more rapidly than did placebo treatment ( p < @ ) , but not ACTH levels .


A positive correlation between ACTH and cortisol values at baseline ( p < @ ) was also found with withdrawal symptom scores and daily dosages of heroin .


Heroin addicts could respond to Jitai tablets through changes in the hypothalamus-pituitary-adrenal axis .


Former cancer patients ' quality of life can be improved by offering social comparison information .


Whether patients , however , benefit from the information may depend on how negative they perceive their present and their future .


We conducted a randomised experimental field study with a pre - and post-measurement .


Dutch former cancer patients - recruited through different media - were assigned to a social comparison intervention condition or a no-intervention control condition ( experimental condition n = @ ; control condition n = @ ; Mage = @ years ) .


In the intervention condition , patients received a @ min computer-tailored interview in audio format .


Patients ' present perceived life threat and future health expectations were measured at pretest .


Quality of life and life satisfaction after @ months were the outcome variables .


The intervention increased life satisfaction only in patients who experienced a high present life threat ( -LSB- Formula : see text -RSB- = @ ) and in patients who had negative future health expectations , the intervention increased quality of life ( -LSB- Formula : see text -RSB- = @ ) .


Not all patients did benefit from the intervention ; for some patients , the social comparison intervention was even detrimental .


Moderator analyses seem necessary to evaluate psycho-social interventions for cancer patients .


At least @ % of mothers experience depression in the first postnatal year , with accompanying feelings of despair and a range of debilitating symptoms .


Serious sequelae include disturbances in the mother-infant relationship and poor long-term cognitive and behavioural outcomes for the child .


Surprisingly , treatment of maternal symptoms of postnatal depression does not improve the mother-infant relationship for a majority of women .


Targeted interventions to improve the mother-infant relationship following postnatal depression are scarce and , of those that exist , the majority are not evaluated in randomised controlled trials .


This study aims to evaluate a brief targeted mother-infant intervention , to follow cognitive behavioural therapy treatment of postnatal depression , which has the potential to improve developmental outcomes of children of depressed mothers .


The proposed study is a two-arm randomised controlled trial with follow-up to @ months .


One hundred participants will be recruited via referrals from health professionals including maternal and child health nurses and general practitioners , as well as self-referrals from women who have seen promotional materials for the study .


Women who meet inclusion criteria ( infant aged < @ months , women @ + years of age ) will complete the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV-TR Axis I Disorders .


Those with a clinical diagnosis of current major or minor depressive disorder and who do not meet exclusion criteria ( that is , currently receiving treatment for depression , significant difficulty with English , medium to high suicide risk , current self-harm , current substance abuse , current post-traumatic stress disorder , current manic/hypomanic episode or psychotic symptoms ) will be randomised to receive either a @-session mother-infant intervention ( HUGS : Happiness Understanding Giving and Sharing ) or a @-session attention placebo playgroup ( Playtime ) following a @-session postnatal depression group treatment programme .


Primary outcome measures are the Parenting Stress Index ( self-report measure ) and the Parent-child Early Relational Assessment ( observational measure coded by a blinded observer ) .


Measurements are taken at baseline , after the postnatal depression programme , post-HUGS/Playtime , and at @ months post-HUGS/Playtime .


This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression .


There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments .


Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions .


We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifurcation lesions with @ widely applied second-generation drug-eluting stents , the zotarolimus-eluting Resolute stent ( Medtronic Inc , Santa Rosa , CA ) and the everolimus-eluting Xience V stent ( Abbott Vascular , Santa Clara , CA ) .


Three-year follow-up was available in @ % .


Patients were categorized into treatment for @ bifurcation lesion versus treatment for nonbifurcation lesions only .


Among the @,@ patients of the TWENTE trial , @ ( @ % ) were treated for bifurcation lesions .


At @-year follow-up , target-vessel failure did not differ between patients treated for bifurcation versus nonbifurcation lesions ( @ % vs @ % ; P = @ ) , whereas the periprocedural myocardial infarction rate was higher in patients with bifurcation lesions ( @ % vs @ % ; P < @ ) .


Of the @ patients with bifurcation lesion treatment , @ ( @ % ) were treated with Resolute and @ ( @ % ) with Xience V.


There was no significant difference in target-vessel failure between the Resolute and Xience V groups with bifurcation treatment ( @ % vs @ % ; P = @ ) , and their incidence of definite-or-probable stent thrombosis was low and similar ( @ % vs @ % , respectively ; P = @ ) .


Despite a significant difference in periprocedural myocardial infarction , @-year clinical outcome after implantation of second-generation stents was favorable and similar for patients with and without bifurcation lesions .


In addition , we observed no difference in long-term clinical outcome after bifurcation lesion treatment with Resolute and Xience V stents .


The aim was to evaluate , using urethral pressure reflectometry ( UPR ) , the effect of fesoterodine on urethral function in women with stress urinary incontinence ( SUI ) .


Women aged @ to @ years were eligible for this randomised , double-blind , placebo-controlled , crossover study if they had had clinically significant SUI or SUI-predominant mixed urinary incontinence for > @ months .


Each participant received fesoterodine @ mg , fesoterodine @ mg , and placebo once daily for @ days , with a @ - to @-day washout between treatments .


UPR was performed at baseline and @ to @ h after the last dose in each treatment period .


Participants completed a @-day bladder diary before randomisation and during the last @ days of each treatment period .


Of the @ women randomly assigned and treated , @ met the criteria for the primary efficacy analyses .


No statistically significant differences were seen between fesoterodine @ mg or fesoterodine @ mg and placebo in opening urethral pressure ( primary endpoint ) or other UPR endpoints .


No statistically significant differences were seen between either fesoterodine dose and placebo in the change from baseline in the bladder diary variables ( total urinary incontinence , SUI , or urgency urinary incontinence episodes per @ h ) .


Adverse events were reported by @ participants taking fesoterodine @ mg , @ taking fesoterodine @ mg , and @ taking placebo .


Fesoterodine did not affect urethral pressure or significantly decrease the number of incontinence episodes in women with SUI .


The UPR parameters showed no placebo effect , while there was a placebo effect of @ % based on the bladder diary .


Insufficient asthma management leads to impaired health-related quality of life ( HRQL ) .


The aim of this study is to assess whether individualized self-management ( ISM ) support will improve HRQL in children with asthma compared to enhanced usual care ( EUC ) in Dutch general practices .


A cluster-randomized controlled trial with @-month follow-up .


ISM is a nurse-led intervention that is optimized to the needs of children , leading to a written action plan .


Power calculation demanded inclusion of @ children ( aged @-@years ) diagnosed with asthma and active medication use .


Outcomes were HRQL of the child ( Paediatric Asthma Quality of Life Questionnaire , PAQLQ-s ) and several secondary outcomes .


Data of @ children ( mean age @ years , SD @ ) were analyzed ; ISM ( n = @ ) or EUC ( n = @ ) .


Logistic regression analysis ( minimal clinical important difference ; MCID@ @ ) and descriptive analyses were performed .


Despite high PAQLQ-s score at baseline ( median ISM @ , EUC @ ) , a substantial number of subjects from both groups showed MCID of HRQL ( ISM @ % , EUC @ % ) .


Treatment differences on HRQL were not significant ( OR @ , @ % CI @ , @ ) .


Secondary outcomes did not show significant differences either , with exception of PAQLQ-s symptoms domain score in favor of EUC .


Due to recruitment problems and underpowered analyses , no firm conclusions on the effectiveness of ISM support for childhood asthma in primary care could be drawn .


Still , this study can be considered a valuable pilot study and in the future , there might be better capacity in general practices to commit to such treatment .


Challenges remain to find ways to support patients with depression who have low levels of physical activity ( PA ) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse .


There is an evidence-base for behavioural activation ( BA ) for depression , which focuses on supporting patients to restore activities that have been avoided , but practitioners have no specific training in promoting PA. .


We aimed to design and evaluate an integrated BA and PA ( BAcPAc ) practitioner-led , written , self-help intervention to enhance both physical and mental health .


This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial ( RCT ) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT .


Following development of the augmented written self-help intervention ( BAcPAc ) incorporating behavioural activation with physical activity promotion , depressed adults are randomised to receive up to @ sessions over a maximum of @months of either BAcPAc or behavioural activation alone within a written self-help format , which represents treatment as usual .


The study is located within two ` Improving Access to Psychological Therapies ' services in South West England , with both written self-help interventions supported by mental health paraprofessionals .


Measures assessed at @ , @ , and @month follow-up include the following : CIS-R , PHQ-@ , accelerometer recorded ( @months only ) and self-reported PA , body mass index , blood pressure , Insomnia Severity Index , quality of life , and health and social care service use .


Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews .


At the time of writing the study has recruited @ patients .


The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse , and bring about improvements across a range of physical health outcomes .


Job rotation has often been used in situations where the level of exposure can not be reduced due to the characteristics of the job or through physical measures .


However , the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data .


A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers .


The randomized cluster was based in characteristics of production sectors .


A total cluster will be @ sectors , and @ workers will be recruited from a textile industry and randomly allocated into intervention or control groups .


Both groups will receive training on ergonomics guidelines .


In addition , the intervention group will perform job rotation , switching between tasks with low , moderate , and high risk for musculoskeletal complaints .


The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases .


Secondary outcomes measured via survey include : body parts with musculoskeletal pain , the intensity of this pain , physical workload , fatigue , general health status , physical activity level , and work productivity .


Secondary outcome measures will be assessed at baseline and after @ , @ , @ , and @ months .


The cost-effectiveness analysis will be performed from the societal and company perspective .


Prevention of work-related musculoskeletal disorders is beneficial for workers , employers , and society .


The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders .


Avoidance of death , disability , dementia , and cognitive dysfunction ( DDCD ) are high priorities for people in aging societies .


Evidence is mounting that these conditions are associated with impaired glycemic control .


The aim of this study was to assess the strength of relationship between the degree of glucose elevation and the development of the composite elements of DDCD that impede successful/healthy aging in a population at high risk for cardiovascular disease .


DESIGN , SETTING , PARTICIPANTS , AND MAIN OUTCOME MEASURE : The relationship between baseline fasting plasma glucose values and DDCD was determined among @ @ participants of the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE intolerant Subjects With Cardiovascular Disease studies followed up for a median of @ years .


Several statistical models were used for the entire cohort and for those with and without normal fasting plasma glucose ( ie , < @ mmol/L ) or a history of diabetes mellitus .


After adjusting for age and sex , a diagnosis of diabetes mellitus was associated with an approximately @ greater odds of DDCD ; every @ mmol/L higher baseline fasting plasma glucose value was associated with a @ ( @ % confidence interval @ , @ ) greater odds .


These associations persisted in the multivariate models ( a @ @ % confidence interval @ , @ greater odds after adjustment for age , sex , education , and depression ) .


In individuals with high cardiovascular risk , a direct relationship exists between levels of dysglycemia and the risk of DDCD .


Further research is needed to understand the mechanisms underlying such an association and whether benefits can be derived from preventative strategies .


Cystic fibrosis-related diabetes is characterized by postprandial , rather than fasting , hyperglycemia .


Gastric emptying and the release of the incretin hormones -LSB- glucagon-like peptide-@ ( GLP-@ ) and glucose dependent insulinotropic polypeptide ( GIP ) -RSB- are central to postprandial glycemic control .


Lipolysis is required for fat to slow gastric emptying and stimulate incretin release .


We aimed to determine the effect of pancreatic enzyme replacement therapy ( PERT ) on postprandial glycemia in adolescents with cystic fibrosis ( CF ) .


This was a double-blinded randomized crossover trial .


Subjects consumed a high-fat pancake , with either PERT ( @ @ IU lipase ) or placebo .


Gastric emptying was measured by a breath test and blood sampled frequently for plasma blood glucose , insulin , glucagon , GLP-@ , and GIP .


Data were also compared with seven healthy subjects .


Fourteen adolescents ( @ @ y ) with pancreatic-insufficient CF and seven healthy age-matched controls participated in the study .


Postprandial hyperglycemia was measured as peak glucose and area under the curve for blood glucose at @ minutes .


CF subjects had postprandial hyperglycemia compared with controls ( area under the curve , P < @ ) .


PERT reduced postprandial hyperglycemia ( P = @ ) , slowed gastric emptying ( P = @ ) , and normalized GLP-@ and GIP secretion ( P < @ for each ) when compared with placebo , without affecting insulin .


In young people with pancreatic insufficient CF , PERT markedly attenuates postprandial hyperglycemia by slowing gastric emptying and augmenting incretin hormone secretion .


To observe the effects of glutamine combined with ulinastatin on inflammatory response of patients with severe burn injury .


Sixty patients with severe burn injury admitted to our burn wards from January @ to December @ conforming to the study criteria were divided into control group ( C , n = @ ) , glutamine group ( G , n = @ ) , and glutamine combined with ulinastatin group ( G + U , n = @ ) according to the random number table .


Another @ healthy volunteers were chosen as normal control group ( NC ) .


Isonitrogenous and isocaloric nutrition supports were given to patients in groups C , G , and G + U from post burn day ( PBD ) @ g/kg protein in the form of glutamine dipeptide was given to patients in group G for @ days .


@ g/kg protein was given to patients in group G + U for @ days with the same amount of glutamine dipeptide as that in group G , followed by intravenous injection of @ kU ulinastatin ( once per @ hours ) for @ days during @ days .


The nitrogen concentration of @ h urine was determined with Kieldahl nitrogen determination method , and nitrogen balance was calculated one day before treatment and ten days after treatment .


Meanwhile , the levels of D-lactate in serum was determined by colorimetric method , the levels of diamine oxidase ( DAO ) , TNF - , and IL-@ by enzyme-linked immunosorbent assay , and LPS level by kinetic turbidimetric assay with TAL .


Above-mentioned indexes were also examined in group NC .


The wound healing rate on PBD @ , total hospital stay days , and the incidence of burn sepsis of all burn patients were recorded .


Data were processed with one-way analysis of variance , LSD test , t test , and chi-square test .


Compared with that in group C -LSB- ( -@ @ ) g/d -RSB- , nitrogen balance in group G was significantly increased ten days after treatment -LSB- ( -@ @ ) g/d , P < @ -RSB- .


The serum levels of D-lactate , DAO , LPS , TNF - , and IL-@ in group G ten days after treatment were significantly lower than those in group C ( P < @ or P < @ ) .


No statistically significant difference was observed in nitrogen balance and the serum levels of D-lactate , DAO between group G + U and group G ( P values all above @ ) .


The serum levels of LPS , TNF - , and IL-@ in group G + U ten days after treatment were respectively ( @ @ ) EU/mL , ( @ @ ) pg/mL , ( @ @ ) pg/mL , which were significantly lower than those in group G -LSB- ( @ @ ) EU/mL , ( @ @ ) pg/mL , ( @ @ ) pg/mL , respectively , P < @ or P < @ -RSB- .


The would healing rate on PBD @ and total hospital stay days in group G were respectively higher and shorter than those in group C ( P values all below @ ) , but no statistically significant difference in the incidence of burn sepsis was found between them ( P > @ ) .


The would healing rate on PBD @ in group G+U -LSB- ( @ @ ) % -RSB- was enhanced , and total hospital stay days -LSB- ( @ @ ) d -RSB- were lowered than those in group G -LSB- ( @ @ ) % , ( @ @ ) d , P values all below @ -RSB- .


The incidence of burn sepsis of patients in group G + U ( @ % ) was significantly lower than that in group C ( @ % , ( @ ) = @ , P < @ ) .


Glutamine combined with ulinastatin treatment can alleviate damage to intestine after severe burn injury , lower the serum level of inflammatory cytokines , promote wound healing , and reduce the incidence of burn sepsis .


The Food Insulin Index ( FII ) is a novel algorithm for ranking foods on the basis of insulin responses in healthy subjects relative to an isoenergetic reference food .


Our aim was to compare postprandial glycemic responses in adults with type @ diabetes who used both carbohydrate counting and the FII algorithm to estimate the insulin dosage for a variety of protein-containing foods .


A total of @ adults on insulin pump therapy consumed six individual foods ( steak , battered fish , poached eggs , low-fat yoghurt , baked beans and peanuts ) on two occasions in random order , with the insulin dose determined once by the FII algorithm and once with carbohydrate counting .


Postprandial glycemia was measured in capillary blood glucose samples at @-@ min intervals over @h .


Researchers and participants were blinded to treatment .


Compared with carbohydrate counting , the FII algorithm significantly reduced the mean blood glucose level ( @ vs @ mmol/l , P = @ ) and the mean change in blood glucose level ( -@ vs @ mmol/l , P = @ ) .


Peak blood glucose was reached earlier using the FII algorithm than using carbohydrate counting ( @ vs @min , P = @ ) .


The risk of hypoglycemia was similar in both treatments ( @ % vs @ % for FII vs carbohydrate counting , respectively , P = @ ) .


In adults with type @ diabetes , compared with carbohydrate counting , the novel FII algorithm improved postprandial hyperglycemia after consumption of protein-containing foods .


To explore the safety in inguinal incarcerated hernia repair without use of antibiotics .


Retrospective statistical analysis was performed for a total @ patients with inguinal incarcerated hernia repair at our hospital from January @ to July @ .


They were divided into @ groups of non-using ( n = @ ) and using ( n = @ ) antibiotics .


Statistical analysis of early postoperative infection was performed for two groups .


The total incision infection had no statistical difference between two groups ( @ % ( @/@ ) vs @ % ( @/@ ) , @ % ( @/@ ) vs @ % ( @/@ ) , both P > @ ) .


Further comparison of leukocyte count and neutrophil count at Day @ showed no inter-group statistical difference ( ( @ @ ) @ ( @ ) vs ( @ @ ) @ ( @ ) / L , ( @ @ ) @ ( @ ) vs ( @ @ ) @ ( @ ) / L ; U = @ , @ ; P = @ , @ ) .


It is unnecessary to use preventive antibiotics in patients undergoing tension-free repair with incarcerated inguinal hernia without high-risk infection or bowel necrosis .


To propose and evaluate a novel surgical approach with minimal trauma , termed interseptal bone reduction , combined with the use of a conventional orthodontic fixed appliance to accelerate canine retraction .


A split-mouth design study was conducted in @ female subjects ( mean age , @ years ) whose bilateral upper first premolars were extracted and who subsequently received canine distalization .


The extraction socket on the experimental side was deepened , and interseptal bone distal to the maxillary canine was reduced in thickness using a surgical bur ; conventional extraction was performed on the control side .


The canines were then distalized using elastomeric chains on both the labial and palatal sides , with a net force of @ g.


The extent of canine movement and rotation was determined from study models , and the angulation was analyzed based on lateral cephalograms .


A Wilcoxon signed rank test demonstrated that the extent of canine movement in the mesio-distal direction after @ months was significantly greater on the experimental side than on the control side ( @ and @ mm , respectively , P = @ ) .


However , there was no statistically significant difference in canine angulation or rotation after @ months between the experimental and control sides .


In combination with the use of conventional orthodontic appliances , interseptal bone reduction can enhance the rate of canine movement when interseptal bone is sufficiently reduced in both thickness and depth following surgical criteria .


Patients with left ventricular diastolic dysfunction ( LVDD ) are at increased risk of postoperative adverse events .


The primary aim of this study was to evaluate the safety and feasibility of using echocardiography-guided hemodynamic management ( EGHEM ) during surgery in subjects with LVDD compared to conventional management .


The feasibility of using echocardiography to direct a treatment algorithm and clinical outcomes were compared for safety between groups .


Subjects were screened for LVDD by preoperative transthoracic echocardiography ( TTE ) and randomized to the conventional or EGHEM group .


Subjects in EGHEM received hemodynamic management based on left ventricular filling patterns on transesophageal echocardiography ( TEE ) .


Primary outcomes measured were the feasibility to obtain TEE images and follow a TEE-based treatment algorithm .


Safety outcomes also compared the following clinical differences between groups : length of hospitalization , incidence of atrial fibrillation , congestive heart failure ( CHF ) , myocardial infarction , cerebrovascular accident , transient ischemic attack and renal failure measured @ days postoperatively .


Population consisted of @ surgical subjects ( @ in conventional group and @ in EGHEM group ) .


Mean subject age was @ @ years ( @ % male ) in conventional group and @ @ years ( @ % male ) in EGHEM group .


Procedures included orthopedic ( conventional = @ % , EGHEM @ % ) , general ( conventional = @ % , EGHEM = @ % ) , vascular ( conventional = @ % , EGHEM = @ % ) , and thoracic ( conventional = @ % , EGHEM = @ % ) .


There was no statistically significant difference in adverse clinical events between the @ groups .


The EGHEM group had less CHF , atrial fibrillation , and shorter length of stay .


Echocardiography-guided hemodynamic management of patients with LVDD during surgery is feasible and may be a safe alternative to conventional management .


To analyze the efficacy and safety of combination of rh-endostatin ( Endostar ) with docetaxel treatment on patients of non-small cell lung cancer ( NSCLC ) who presented PD or intolerable toxicity in/after first-line chemotherapy .


A randomized , double-blind , placebo-controlled and multi-center clinical trial was conducted .


Patients with stage IIIB/IV of NSCLC experienced previous chemotherapy of one-regimen were screened for this trial .


A total of @ cases were included in this study .


Single docetaxel and that combined with endostar were conducted in two arms .


The response , time to progression ( TTP ) and adverse effects were observed in both arms .


The objective response rate ( ORR ) and clinical benefit rate ( CBR ) were @ and @ % in the combined arm , along with @ and @ % in the single docetaxel arm , with a non-significant difference between the two groups ( all P > @ ) , respectively .


The median TTPs in the combined and single docetaxel arms were @ and @ months , respectively ( P = @ ) .


The median TTPs of the participants with progressive disease ( PD ) after first-line chemotherapy were @ and @ months in the combined and single docetaxel arms , respectively ( P = @ ) .


The median TTPs of the participants with intolerant adverse effects in first-line chemotherapy were @ months and @ months in the combined and single docetaxel arms , respectively ( P = @ ) .


The median TTPs of the patients with SD after @ therapeutic cycles in the combined and single docetaxel arms were @ months and @ months , respectively ( P = @ ) .


The differences between two arms were non-significant in adverse , serious adverse and cardiovascular adverse effects ( all P > @ ) .


Endostar may prolong TTP in patients with advanced NSCLC benefited from docetaxel treatment without increased toxicities .


To assess subjective preference using three nasal hygiene systems : Strimar Original ( ) , Emcur ( ) and Sinus Rinse .


We used a prospective , single-blind , randomised , crossover study to compare three nasal hygiene systems : Strimar Original , Emcur and Sinus Rinse .


Eighteen adult volunteers were recruited and were asked to rate their experience over three days using three well-established nasal hygiene systems .


A standard visual analogue scale was used to assess five criteria : ( @ ) simplicity of instructions ; ( @ ) ease of use ; ( @ ) comfort ; ( @ ) perceived nasal clearance ( effectiveness ) and ( @ ) single best overall system .


Strimar Original was found to have the easiest instructions to understand compared to the other two systems .


There was no significant difference between Strimar Original and Sinus Rinse with regards to ease of use but they were both significantly easier to use than Emcur ( p < @ ) .


There was no statistically significant difference between the three systems when comparing the last three criteria .


There was no alteration in preference when the cost of each treatment was disclosed to the subjects , and no significant side effects were reported .


The instructions accompanying Strimar Original appeared to be the easiest to understand , while Strimar Original and Sinus Rinse were easier to use than Emcur .


Metastases-directed therapy ( MDT ) with surgery or stereotactic body radiotherapy ( SBRT ) is emerging as a new treatment option for prostate cancer ( PCa ) patients with a limited number of metastases ( @ ) at recurrence - so called `` oligometastases '' .


One of the goals of this approach is to delay the start of palliative androgen deprivation therapy ( ADT ) , with its negative impact on quality of life .


However , the lack of a control group , selection bias and the use of adjuvant androgen deprivation therapy prevent strong conclusions from published studies.The aim of this multicenter randomized phase II trial is to assess the impact of MTD on the start of palliative ADT compared to patients undergoing active surveillance .


Patients with an oligometastatic recurrence , diagnosed on choline PET/CT after local treatment with curative intent , will be randomised in a @:@ ratio between arm A : active surveillance only and arm B : MTD followed by active surveillance .


Patients will be stratified according to the location of metastasis ( node vs. bone metastases ) and PSA doubling time ( @ vs. > @ months ) .


Both surgery and SBRT are allowed as MDT .


Active surveillance means @-monthly PSA testing and re-imaging at PSA progression .


The primary endpoint is ADT-free survival .


ADT will be started in both arms at time of polymetastatic disease ( > @ metastatic lesions ) , local progression or symptoms .


The secondary endpoints include progression-free survival , quality of life , toxicity and prostate-cancer specific survival .


This is the first randomized phase @ trial assessing the possibility of deferring palliative ADT with MDT in oligometastatic PCa recurrence .


Sclerostin is secreted by osteocytes .


As a circulating inhibitor of the Wnt-signaling pathway it inhibits bone formation and contributes to the development of osteoporosis .


Sclerostin levels are elevated in patients with chronic kidney disease and end-stage renal disease .


Since data for patients after kidney transplantation are scarce , we have prospectively measured sclerostin levels before and during the first year after renal transplantation and have examined the association of sclerostin with parameters of bone mineral metabolism and with bone mineral density .


Sclerostin levels were measured by ELISA in @ consecutive renal transplant recipients before and at defined intervals in the first year after transplantation .


Bone mineral density was measured by dual energy X-ray absorptiometry .


Pre-transplant serum sclerostin levels were elevated in all patients ( @ @ pmol/l , normal range @-@ pmol/l ) .


Within @ days after transplantation and correlating with the improvement of renal function , sclerostin levels dropped to @ @ pmol/l and subsequently increased to @ @ and @ @ pmol/l after @ and @ months , respectively ( P < @ ) .


A linear mixed model indicated that pre-transplant sclerostin levels ( P < @ ) and time after transplantation ( P < @ ) were the most important predictors for the rise of post-transplant sclerostin levels .


No correlation was found between post-transplant sclerostin levels and bone mineral density .


The rapid reduction of elevated serum sclerostin levels shortly after kidney transplantation parallels the improvement of renal function , but contrasts with the more delayed improvement of hyperparathyroidism .


The normalization of both hormones could contribute to improved bone health after renal transplantation .


Lung age , a simple concept for patients to grasp , is frequently used as an aid in smoking cessation programs .


Lung age equations should be continuously updated and should be made relevant for target populations .


We observed how new lung age equations developed for Australian populations performed when utilizing the Burden of Obstructive Lung Disease ( BOLD ) - Australia dataset compared to more commonly used equations .


Data from a cross-sectional population study of noninstitutionalized Australians aged @ years with analysis restricted to Caucasians < @ years .


Lung age calculated using equations developed by Newbury et al. and Morris and Temple was compared with chronological age by smoking status and within smoking status .


There were @,@ participants with a mean age of @ ( @ SD ) years .


More than half ( @ % ) ever smoked , and @ % were current smokers .


Prevalence of chronic obstructive pulmonary disease stage I or higher was @ % ( @ % confidence interval = @ , @ ) .


For both genders , newer Newbury equations estimated lung ages significantly higher than actual age across all smoking groups ( p < @ ) .


Morris and Temple equations resulted in lung age estimates significantly lower than chronological age for nonsmokers ( p < @ ) but no difference among current smokers .


Both equations showed exposure to smoking had lung ages higher than never-smokers ( p < @ ) .


Lung age also increased with increased pack-years .


This supports the use of updated equations suited to the population of interest .


The Australian Newbury equations performed well in the BOLD-Australia dataset , providing more meaningful lung age profile compared to chronological age among smokers .


Using equations not developed or ideally suited for our population is likely to produce misleading results .


There is significant morbidity and mortality caused by the complications of osteoporosis , for which ageing is the greatest epidemiological risk factor .


Preventive medications to delay osteoporosis are available , but little is known about motivators to adhere to these in the context of a symptomless condition with evidence based on screening results .


To describe key perceptions that influence older women 's adherence and persistence with prescribed medication when identified to be at a higher than average risk of fracture .


A longitudinal qualitative study embedded within a multi-centre trial exploring the effectiveness of screening for prevention of fractures .


Primary care , Norfolk .


United Kingdom .


Thirty older women aged @-@ years of age who were offered preventive medication for osteoporosis and agreed to undertake two interviews at @ and @ months post-first prescription .


There were no overall predictors of adherence which varied markedly over time .


Participants ' perceptions and motivations to persist with medication were influenced by six core themes : understanding adherence and non-adherence , motivations and self-care , appraising and prioritising risk , anticipating and managing side effects , problems of understanding , and decision making around medication .


Those engaged with supportive professionals could better tolerate and overcome barriers such as side-effects .


Many issues are raised following screening in a cohort of women who have not previously sought advice about their bone health .


Adherence to preventive medication for osteoporosis is complex and multifaceted .


Individual participant understanding , choice , risk and perceived need all interact to produce unpredictable patterns of usage and acceptability .


There are clear implications for practice and health professionals should not assume adherence in any older women prescribed medication for the prevention of osteoporosis .


The beliefs and motivations of participants and their healthcare providers regarding the need to establish acceptable medication regimes is key to promoting and sustaining adherence .


To evaluate the efficacy of Oraqix during scaling and root planing ( SRP ) in comparison with @ % benzocaine and placebo .


@ patients requiring @ sessions of SRP were enrolled .


For each patient , Oraqix , Hurricaine , vaseline or no anesthetic product were randomly assigned each to a quadrant .


Treatment pain was evaluated on a @ mm Visual Analog Scale ( VAS ) and on a Verbal Rating Scale ( VRS ) .


The amount of product administered , the need to re-anesthetise , patient and operator satisfaction and the onset of side-effects were also recorded .


Oraqix was significantly better than nothing , with a reduction of VAS score to @ units , but without significant differences with Vaseline or Hurricaine .


Oraqix was better in VRS reduction than not using any anesthetic ( p = @ ) or using vaseline ( p = @ ) , but similar to Hurricaine ( p = @ ) .


Oraqix effectively controls pain in SRP procedures , with few side-effects and a good acceptance on the part of patients and clinicians .


Superficial fungal skin infections are treated using topical antifungals .


The aim of this study was to demonstrate the efficacy of a single application of @ % terbinafine film-forming solution ( FFS ) versus placebo for the treatment of tinea pedis in the Chinese population .


Six centers in China randomized @ patients in a @:@ ratio to receive either @ % terbinafine FFS or FFS vehicle ( placebo ) once on the affected foot/feet .


Efficacy assessments included microscopy and mycologic culture , and assessing clinical signs and symptoms at baseline , and at weeks @ and @ after the topical treatment .


All adverse events were recorded .


At week @ , @ % terbinafine FFS was superior to placebo for effective treatment rate ( @ vs. @ % ) ; clinical cure ( @ vs. @ % ) ; mycological cure ( @ vs. @ % ) ; negative microscopy ( @ vs. @ % ) ; and negative mycological culture ( @ vs. @ % ) : all p @ and clinically relevant .


At week @ , @ % terbinafine FFS was clinically superior to placebo for the absence of : erythema ( @ vs. @ % ) ; desquamation ( @ vs. @ % ) ; and pruritus ( @ vs. @ % ) : all p @ and clinically relevant .


At week @ , differences in the average total signs and symptoms scores were significantly lower for @ % terbinafine FFS versus placebo ( p @ ) .


Both @ % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments .


This double-blind , randomized , multicenter study demonstrated one single topical application of @ % terbinafine FFS was safe and effective in the treatment of tinea pedis in the Chinese population .


Postoperative nausea and vomiting ( PONV ) is common ; ondansetron is often used as prophylaxis or for breakthrough episodes .


Vestipitant is a neurokinin @ ( NK-@ ) receptor antagonist that is effective for prophylaxis , but its efficacy for treating established PONV is unknown .


This study was performed to evaluate the efficacy and safety of vestipitant , compared with ondansetron for the treatment of breakthrough PONV in patients who had already received prophylactic ondansetron before surgery .


A multicentre , randomized , single-blind ( sponsor-open ) , parallel group study .


Of @ surgical patients , @ ( @ % ) had breakthrough PONV and were equally randomized to one of six i.v. doses of vestipitant ( @-@ mg ) or ondansetron @ mg .


The primary endpoint was the rate of patients exhibiting complete response , defined as no emesis and no further rescue medication from @ min after infusion up to @ h after surgery or hospital discharge .


All doses of vestipitant were non-inferior to ondansetron in treating PONV after failed prophylaxis with ondansetron .


However , vestipitant was superior to ondansetron in decreasing episodes of postoperative emesis and retching .


The complete response rate analysis using Bayesian model averaging indicated that no vestipitant dose was superior to ondansetron .


Nausea numerical rating scale scores and the times-to-PONV or discharge were similar between the vestipitant and ondansetron treatment groups .


Although overall efficacy was non-inferior between vestipitant and ondansetron , the rate of emesis was lower with vestipitant .


These data suggest that vestipitant may be a useful agent for the management of PONV , similar to other NK-@ antagonists .


To evaluate the impact of manual vibrocompression and nasotracheal suctioning on heart ( hr ) and respiratory ( rr ) rates , peripheral oxygen saturation ( SpO ( @ ) ) , pain and respiratory distress in infants in the postoperative period of a cardiac surgery .


Randomized controlled trial , in which the assessments were performed by the same physiotherapist in two moments : before and after the procedure .


The infants were randomly divided into two groups : Intervention ( IG ) , with manual chest vibrocompression , nasotracheal suctioning and resting ; and Control CG ) , with @ minutes of rest .