The test formulation met the regulatory criteria for assuming bioequivalence to the reference formulation for both AUCt and C max .


The additional genetic analysis demonstrated that the major metabolic enzymes of erlotinib did not significantly affect erlotinib metabolism , with the exception of CYP@A@ * @M .


Chronic infection with Pseudomonas aeruginosa is associated with an increased exacerbation frequency , a more rapid decline in lung function , and increased mortality in patients with bronchiectasis .


To perform a randomized placebo-controlled study assessing the efficacy and safety of inhaled colistin in patients with bronchiectasis and chronic P. aeruginosa infection .


Patients with bronchiectasis and chronic P. aeruginosa infection were enrolled within @ days of completing a course of antipseudomonal antibiotics for an exacerbation .


Participants were randomized to receive colistin ( @ million IU ; n = @ ) or placebo ( @ % saline ; n = @ ) via the I-neb twice a day , for up to @ months .


The primary endpoint was time to exacerbation .


Secondary endpoints included time to exacerbation based on adherence recorded by the I-neb , P. aeruginosa bacterial density , quality of life , and safety parameters .


All analyses were on the intention-to-treat population .


Median time ( @ % quartile ) to exacerbation was @ ( @ ) versus @ ( @ ) days in the colistin and placebo groups , respectively ( P = @ ) .


In adherent patients ( adherence quartiles @-@ ) , the median time to exacerbation was @ ( @ ) versus @ ( @ ) days in the colistin and placebo groups , respectively ( P = @ ) .


P. aeruginosa density was reduced after @ ( P = @ ) and @ weeks ( P = @ ) and the St. George 's Respiratory Questionnaire total score was improved after @ weeks ( P = @ ) in the colistin versus placebo patients , respectively .


There were no safety concerns .


Although the primary endpoint was not reached , this study shows that inhaled colistin is a safe and effective treatment in adherent patients with bronchiectasis and chronic P. aeruginosa infection .


Clinical trial registered with http://www.isrctn.org/ ( ISRCTN@ ) .


Rubbing the skin may influence the persistence of pustulosis over time .


The aim of this study was to assess the impact of a new fabric made with fluorine-synthetic fiber in improving plantar pustulosis .


A total of @ patients were randomized to receive on one side a sock made of fluorine-synthetic fiber and on the other a sock made of cotton fabric for @ weeks .


The main outcome was the percentage reduction of lesional area at week @ .


The median lesion reduction at week @ was @ % in the fluorine-synthetic fiber arm and @ % in the cotton arm ( p = @ ) .


Among secondary outcomes , the overall reduction over time in the treated areas was significantly in favor of the fluorine-synthetic fiber arm ( p = @ ) as well as the perception of the disease by the patient ( p = @ ) .


Despite the fact that the primary outcome was not reached , there was a tangible reduction in the extension of the treated areas and in the perception of the disease by the patient .


To assess the effectiveness of an educational intervention based on social cognitive theory on increasing consumption of fruit and vegetable among Grade @ students .


The randomised study was conducted in Isfahan , Iran , during @ and comprised @ students , who were randomly divided into intervention and control groups .


Data was collected at the beginning and three months after the intervention .


A self-administered questionnaire based on constructs of social cognitive theory and food consumption was used .


Theory-based nutrition education was imparted on the intervention group .


Data was analysed using SPSS @ and appropriate statistical tests .


The intervention group had @ ( @ % ) subjects , while there were @ ( @ % ) controls .


After the intervention , mean scores of behavioural capability ( p < @ ) , self-efficacy in difficult situations ( p = @ ) , self-efficacy in selecting fruits and vegetables ( p = @ ) , social support ( p = @ ) , and observational learning ( p = @ ) had significantly improved in the intervention group .


Nutritional behaviour also showed significant improvement on mean daily intake of fruits and vegetables in the intervention group ( p < @ ) .


Intervention based on social cognitive theory led to increase in the consumption of fruits and vegetables among students , which confirmed the efficiency of social cognitive theory for such interventions .


Low-frequency , bilateral stimulation of the subthalamic nucleus can improve axial symptoms of advanced Parkinson 's disease ( PD ) , but it is not particularly effective for segmental symptoms .


The optimal contacts for low-frequency ( @ Hz ) and high-frequency ( @ Hz ) single monopolar stimulation were determined .


Then , in a randomized , double-blind , prospective crossover manner , @-Hz and @-Hz stimulations via the respective optimal contacts were compared for immediate efficacy in improving the motor function of patients with PD .


The optimal contacts for @-Hz stimulation were situated more ventrally than those for @-Hz stimulation ( P = @ ) .


Under the respective optimal , single monopolar stimulation , @ Hz provided superior efficacy over @ Hz in improving the total Unified Parkinson 's Disease Rating Scale motor score ( P < @ ) and the akinesia ( P = @ ) and axial motor signs ( P = @ ) subscores without compromising the therapeutic effect on tremor and rigidity .


Low-frequency stimulation via the optimal contacts is effective in improving overall motor function of patients with PD .


Cesarean delivery is a common surgical procedure with anticipated substantial postoperative pain .


The addition of a transversus abdominis plane block ( TAPB ) to a multimodal analgesic regimen that includes intrathecal morphine may provide improved early pain outcomes and decrease the risk of chronic post-surgical pain .


The purpose of this research was to assess the ability of an ultrasound-guided TAPB with low-dose ropivacaine to decrease early postoperative pain , opioid consumption , and risk of developing persistent pain when compared with a placebo block .


Eighty-three women were randomly assigned to either a treatment ( @ % ropivacaine ) or control group ( @ % saline ) in this double-blind trial , and @ women were included in the final analysis .


Ultrasound-guided TAPBs were performed with an injection of @mL of study solution per side .


The primary outcome measures of this study were : pain at rest and pain after movement measured with a numeric rating scale , results of the Quality of Recovery-@ ( QoR-@ ) questionnaire , and opioid consumption at @ hr .


These were used with an a priori sample size calculation to detect a @ % reduction in pain scores , a @ % improvement in QoR-@ score , and a @ % reduction in opioid consumption .


Health quality and physical functioning were assessed using the Short Form @ ( SF-@ ) Health Survey at @days and six months .


Assessment at @ hr after Cesarean delivery revealed no clinically important differences between groups in postoperative pain , QoR-@ , or opioid consumption .


There were no clinically important differences between groups regarding measures of nausea , pruritus , vomiting , urine retention ( @ , @ , and @ hr postoperatively ) , @-hr QoR-@ sub-dimensions , or the SF-@ Health Survey ( @days and six months postoperatively ) .


Ultrasound-guided TAPB did not improve postoperative pain , quality of recovery , or opioid consumption @ hr following surgery .


Similar health and functioning ( SF-@ ) at @days and six months were reported by both groups .


This trial was registered at ClinicalTrials.gov number : NCT@ .


Although the prevalence of congenital malformations is high in China , little information is available on the Hainan Province .


Data used in this study were collected from @ to @ by monitoring newborns ( including both live births and stillbirths ) in the Hainan Province .


Comparison analyses were conducted by performing ( @ ) tests .


The data showed an increasing temporal trend of the birth defect prevalence in the Hainan Province ; however , the rate of birth defects changed over time .


The Hainan Province is confronted with the challenge to reduce the prevalence of birth defects .


Interventions should focus on the rural areas where a higher prevalence of birth defects is observed .


The incidence of Clostridium difficile infection ( CDI ) has risen dramatically during the last decade .


Although patients respond well to medical therapy such as vancomycin , @ % -@ % of patients treated suffer a recurrence of CDI .


We developed a simple/practical scoring rule ( logistic regression model ) for recurrent CDI using data from @ large phase @ clinical trials .


Seventy-seven baseline CDI factors were classified : demographics , comorbidity , medications , vital signs , laboratory tests , severity , and symptoms .


Predictors with the highest discrimination in each class ( using receiver operating characteristics curve ) were selected .


For the final model , stepwise selection was performed .


Discrimination , calibration , and internal validation were used to assess the model .


The final model with a simple scoring rule was developed .


It includes @ independent risk factors that are readily available when the patient makes initial contact : age ( < @ vs @ years ) , number of unformed bowel movements during previous @ hours ( < @ vs @ ) , serum creatinine leves ( < @ mg/dL vs @ mg/dL ) and prior episode of CDI ( yes vs no ) .


In addition , the model includes choice of treatment ( vancomycin or fidaxomicin ) .


The prediction model for recurrence may be useful for treatment decision .


The Occluded Artery Trial ( OAT ) randomized stable patients ( n = @ ) > @ h ( calendar days @-@ ) after myocardial infarction ( MI ) with totally occluded infarct-related arteries ( IRA ) , to percutaneous coronary intervention ( PCI ) with optimal medical therapy , or optimal medical therapy alone ( MED ) .


PCI had no impact on the composite of death , reinfarction , or class IV heart failure over extended follow-up of up to @ years .


We evaluated the impact of early and late reinfarction and definition of MI on subsequent mortality .


Reinfarction was adjudicated according to an adaptation of the @ universal definition of MI and the OAT definition ( @ of the following -- symptoms , EKG and biomarkers ) .


Cox regression models were used to analyze the effect of post-randomization reinfarction and baseline variables on time to death .


After adjustment for baseline characteristics the @ ( PCI : n = @ ; MED : n = @ ) patients who developed reinfarction by the universal definition had a @-fold ( @ % CI @-@ @ , p < @ ) increased risk of death compared to patients without reinfarction .


This risk was similar for both treatment groups ( interaction p = @ ) and when MI was defined by the stricter OAT criteria .


Reinfarctions occurring within @ months of randomization had similar impact on mortality as reinfarctions occurring later , and the impact of reinfarction due to the same IRA and a different epicardial vessel was similar .


For stable post-MI patients with totally occluded infarct arteries , reinfarction significantly independently increased the risk of death regardless of the initial management strategy ( PCI vs. MED ) , reinfarction definition , location and early or late occurrence .


Attention-deficit/hyperactivity disorder ( ADHD ) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood .


However , up to @ % of children treated with stimulants either fail to show an improvement or suffer adverse side effects , including decreased appetite , insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD .


A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD , leading to e.g. significant and stable improvement in behavior , attention and IQ .


Significant treatment effects of neurofeedback have also been verified in meta-analyses .


Most of the trials , however , have been criticized for methodological difficulties , particularly lacking appropriate control conditions and number of patients included .


This randomized study examines the efficacy of slow cortical potentials ( SCP ) - neurofeedback , controlling unspecific effects of the setting by comparing two active treatment modalities .


A total of @ patients with ADHD , older than six and younger than ten years , in some cases with additional pharmacological treatment , are included in this trial .


In five trial centres patients are treated either with SCP-feedback or electromyographic ( EMG ) - feedback in @ sessions within @months .


A comprehensive test battery is conducted before and after treatment and at follow-up @month later , to assess core symptoms of ADHD , general psychopathology , attentional performance , comorbid symptoms , intelligence , quality of life and cortical arousal .


The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study .


In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables .


Further , the choice of EMG-biofeedback as an active control condition is debated .


Medications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension .


Capsules including Umezu polyphenols ( UP ) , polyphenols in Japanese plums , may help them to control their blood pressure ( BP ) .


The aim of this study is to evaluate the effectiveness of UP on BP and its safety .


A total of @ healthy workers without antihypertensive medication who had some concerns about their BP , preferably normal-high BP or hypertension level @ , were randomized in a double-blind manner into UP ingesting and placebo groups .


Each subject was instructed to take four capsules daily for @ weeks ( daily UP dose , @ mg for the UP ingesting group ; and @ mg for the placebo group ) .


These subjects were followed for @ weeks , and their BP both at home and at the examination site , as well as self-perceived quality-of-life outcomes and possible side effects , was monitored during that period .


Group time interactions on BP changes were examined .


All of the @ subjects completed the @-week intervention trial .


The BP changes did not significantly differ between the UP ingesting and placebo groups , neither at the examination site nor at home .


But during the study period , no adverse effects were observed .


No remarkable effect of UP on BP was observed .


However , a higher dose of UP was confirmed safe and high in adherence in this @-week randomized controlled trial .


Its effect on BP and other outcomes shall be confirmed in a larger sample .


The purpose of our study was two-fold : @ ) adapt and test a social support measure specific to the experiences of African American women with type @ diabetes mellitus ( T@DM ) ; @ ) examine its relationship to psychosocial measures .


@ rural African American women with uncontrolled T@DM participating in a randomized controlled trial completed surveys at baseline on their social support , empowerment , self-care , self-efficacy , depression and diabetes distress .


Exploratory factor analysis and correlation analysis were conducted to test the psychometric properties of the Dunst Family Support Scale adapted for AA women with T@DM ( FSS-AA T@DM ) and its relationship with other psychosocial measures .


The @ items of the FSS-AA T@DM loaded onto three distinct factors : parent and spouse/partner support , community and medical support , and extended family and friends support .


Reliability for the entire scale was good ( Cronbach 's = @ ) and was acceptable to high across these three factors ( Cronbach 's of @ , @ , and @ respectively ) .


All three factors were significantly correlated with self-reported empowerment , self-care , self-efficacy , depression and diabetes distress , although the pattern was different for each factor .


FSS-AA-T@DM showed good concurrent validity when compared with similar items on the Diabetes Distress Scale .


The FSS-AA T@DM , a @-item scale measuring social support among rural African American women with T@DM , is internally consistent and reliable .


Findings support the utility of this screening tool in this population , although additional testing is needed with other groups in additional settings .


To study the influence of laser radiation on the parameters of microcirculation in patients with gastroesophageal reflux disease ( GERD ) .


The examined @ patients with GERD aged @ to @ years .


@ patients were given a ten-day course of intravenous laser therapy , which was conducted with the help of the apparatus of laser therapy `` matrix-vlok '' ( produced by `` the matrix '' , Russia ) with wavelength @,@ microns , the radiation power at the output of the main fiber @-@ ,@ mW , continuous mode radiation .


The studied parameters were determined before and after treatment .


The obtained data testify to the improvement of microcirculation in patients with GERD under the influence of laser therapy .


Signs and symptoms of Cushing 's disease are associated with high burden of illness .


In this analysis , we evaluated the effect of pasireotide treatment on signs and symptoms in patients with Cushing 's disease .


Phase III study with double-blind randomization of two pasireotide doses .


Patients ( n = @ ) with persistent/recurrent or de novo Cushing 's disease and urinary free cortisol ( UFC ) levels @ upper limit of normal ( ULN ) were randomized to receive subcutaneous pasireotide ( @/@ g bid ) .


At month @ , patients with UFC @ ULN and not exceeding the baseline value continued their randomized dose ; all others received @ g bid uptitration .


At month @ , patients could enter an open-label phase until month @ with a maximal dose of @ g bid .


Changes in signs and symptoms of hypercortisolism over @ months ' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control .


Reductions in blood pressure were observed even without full UFC control and were greatest in patients who did not receive antihypertensive medications during the study .


Significant reductions in total cholesterol and low-density lipoprotein ( LDL ) - cholesterol were observed in patients who achieved UFC control .


Reductions in BMI , weight and waist circumference occurred during the study even without full UFC control .


Adverse effects were typical of somatostatin analogues except for hyperglycaemia-related events , which were experienced by @ % of patients .


In the largest Phase III study of medical therapy in Cushing 's disease , significant improvements in signs and symptoms were seen during @ months of pasireotide treatment , as UFC levels decreased .


Tenofovir disoproxil fumarate ( TDF ) has been associated with renal insufficiency .


Co-administration with boosted protease inhibitors , which increases its exposure , may further increase the risk of renal insufficiency .


We compared the incidence of renal events among women taking TDF co-administered with lopinavir/ritonavir ( LPV/r ) versus those co-administering TDF with nevirapine ( NVP ) .


Renal events were defined as a confirmed drop in creatinine clearance associated with a serum creatinine grade @ or higher , or that leading to treatment modification .


Overall , @ HIV-infected women were enrolled into the study .


Of these , @ ( @ % ) had reportable renal events ( @ in LPV/r arm , six in NVP arm ) .


In multivariate analysis , renal events were significantly associated with the LPV/r arm -LSB- odds ratio ( OR ) @ , @ % confidence interval ( CI ) @ , @ ; P = @ -RSB- , baseline HIV-@ RNA ( OR @ , @ % CI @ , @ per @ log@ copies/ml higher ; P = @ ) and baseline creatinine clearance ( OR @ , @ % CI @-@ @ per @ ml/min higher ; P = @ ) .


In multivariate analysis evaluating renal events requiring treatment modification , only baseline HIV-@ RNA and creatinine clearance were significantly associated ( OR @ , @ % CI @ , @ per @ log@ copies/ml higher ; P = @ and OR @ , @ % CI @ , @ per @ ml/min higher ; P = @ , respectively ) .


The rates of renal events were relatively low in the two treatment arms .


However , patients taking TDF co-administered with LPV/r had significantly more renal events compared to those co-administered with NVP .


Furthermore , higher baseline HIV RNA and lower creatinine clearance were associated with the development of renal insufficiency requiring treatment modification .


The aim of this study was to evaluate the safety , feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training ( TOCT ) in a sample of multiple sclerosis ( MS ) subjects on walking competency , mobility , fatigue and health-related quality of life ( HRQoL ) .


@ MS subjects ( EDSS @ , @ female and @ male , @ years , MS duration @ years ) have been enrolled and randomly assigned to @ treatment groups : ( i ) experimental group received @ TOCT sessions over @ weeks ( @ hours/each session ) followed by a @ months home exercise program , whereas control group did not receive any specific rehabilitation intervention .


A feasibility patient-reported questionnaire was administered after TOCT .


Functional outcome measures were : walking endurance ( Six Minute Walk Test ) , gait speed ( @ Meter Walk Test ) , mobility ( Timed Up and Go test ) and balance ( Dynamic Gait Index ) .


Furthermore , self-reported questionnaire of motor fatigue ( Fatigue Severity Scale ) , walking ability ( Multiple Sclerosis Walking Scale - @ ) and health-related quality of life ( Multiple Sclerosis Impact Scale - @ ) were included .


Subjects ' assessments were delivered at baseline ( T@ ) , after TOCT ( T@ ) and @ months of home-based exercise program ( T@ ) .


After TOCT subjects reported a positive global rating on the received treatment .


At @ months , we found a @ % of adherence to the home-exercise program .


After TOCT , walking ability and health-related quality of life were improved ( p < @ ) with minor retention after @ months .


The control group showed no significant changes in any variables .


This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments ; moreover it might improve walking abilities .


To evaluate the safety and efficacy of a supraciliary micro-stent ( CyPass Micro-Stent ; Transcend Medical , Menlo Park , California , USA ) for surgical treatment of glaucoma in patients refractory to topical medications .


Multicenter , single-arm interventional study .


Patients with open-angle glaucoma ( Shaffer Grade @ and @ ) and uncontrolled medicated intraocular pressure ( IOP ) > @mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled .


Glaucoma medications were discontinued at surgery and resumed at investigator discretion .


CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach .


Adverse events , postoperative IOP changes , and need for IOP-lowering medications during the first @ postoperative months ( @M ) were monitored .


Sixty-five eyes were enrolled , and @ were available at @M , accounting for loss to follow-up and early termination .


Baseline IOP was @ @ mm Hg , and the mean number of medications recorded was @ @ .


There were no serious intraoperative events or major adverse events ( eg , retinal or choroidal detachment , persistent uveitis , persistent hyphema , hypotony maculopathy ) .


The most common adverse events included IOP increases > @mm Hg beyond @month ( @ % , @/@ ) , transient hyphema ( @ % , @/@ ) , and cataract progression ( @ % , @/@ phakic eyes ) .


Mean IOP was @ @ mm Hg at @months-a @ % reduction ( P < @ ) .


Mean medication usage also decreased from baseline to a mean of @ @ medications at @M ( P = @ ) .


In eyes originally indicated for conventional glaucoma surgery , no secondary surgery was performed in @ % ( @/@ ) .


Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma , precluding the need for more invasive glaucoma surgery in > @ % of patients at @ year , therebyreducing postoperative glaucoma surgical complications .


We evaluated the outcome of person-centred and integrated Palliative advanced home caRE and heart FailurE caRe ( PREFER ) with regard to patient symptoms , health-related quality of life ( HQRL ) , and hospitalizations compared with usual care .


From January @ to October @ , @ ( @ males , @ females , mean age @ years ) patients with chronic heart failure ( NYHA class III-IV ) were randomized to PREFER and @ ( @ males , @ females , mean age @ years ) to the control group at a single centre .


Prospective assessments were made at @ , @ , and @ months using the Edmonton Symptom Assessment Scale , Euro Qol , Kansas City Cardiomyopathy Questionnaire , and rehospitalizations .


Between-group analysis revealed that patients receiving PREFER had improved HRQL compared with controls ( @ vs. @ , age-adjusted P-value = @ ) .


Within-group analysis revealed a @ % improvement in the PREFER group for HRQL ( P = @ ) compared with @ % ( P = @ ) in the control group .


Nausea was improved in the PREFER group ( @ vs. @ , P = @ ) , and total symptom burden , self-efficacy , and quality of life improved by @ % ( P = @ ) , @ % ( P = @ ) , and @ % ( P = @ ) , respectively .


NYHA class improved in @ of the @ ( @ % ) PREFER patients compared with @ of the @ ( @ % ) control patients ( P = @ ) .


Fifteen rehospitalizations ( @days ) occurred in the PREFER group , compared with @ ( @days ) in the control group .


Person-centred care combined with active heart failure and palliative care at home has the potential to improve quality of life and morbidity substantially in patients with severe chronic heart failure .


The practice of traditional Chinese medicine ( TCM ) has a profound history in many Asian countries .


TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients .


Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine .


Owing to its distinctive way of interpreting illness and administering care , medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs .


Currently , the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation .


In this multicenter , randomized , controlled , double-blind , double-dummy clinical trial , in which we will use the comparative effectiveness research method , we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome .


A total of @ patients will be recruited and randomly assigned to receive either ( @ ) QiShenYiQi dripping pills , Tongxinluo placebo and routine medication or ( @ ) Tongxinluo capsules , QiShenYiQi placebo and routine medication .


These treatment regimens will be carried out for @weeks , followed by a @-day washout period and a @-week crossover phase in which the treatments in the two patient groups will be exchanged .


Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly .


Patient-reported outcomes such as the Seattle Angina Questionnaire score and the @-point Likert scale score will be measured and reported .


The minimally clinical important difference will be calculated and used for efficacy assessment , and correspondence analysis will be performed to identify the best indications for each drug .


The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective .


The findings of this study will inform the practicality of the proposed evaluation method .


Patients with anxious depression are typically more difficult to treat with monoaminergic antidepressants compared to those with nonanxious depression .


Although novel research has shown that the N-methyl-D-aspartate ( NMDA ) receptor antagonist ketamine has rapidly acting , relatively sustained effects in treating depression , we predicted that , consistent with the existent literature on traditional antidepressants , patients with anxious depression would have a poorer antidepressant response .


Twenty-six inpatients with treatment-resistant major depressive disorder ( MDD ) ( DSM-IV criteria ) received a single infusion of ketamine ( @ mg/kg over @ minutes ) from January @-March @ and were followed for @ days .


A post hoc analysis compared treatment response and relapse using the Montgomery-Asberg Depression Rating Scale ( MADRS ) in patients with anxious versus nonanxious depression .


Anxious depression was defined as MDD plus a Hamilton Depression Rating Scale anxiety/somatization factor score @ .


Both anxious and nonanxious depressed patients responded positively to ketamine .


A linear mixed model controlling for baseline with the MADRS revealed a significant group main effect ( P = @ ) and group-by-time interaction ( P = @ ) .


Post hoc tests indicated that patients with anxious depression had significantly fewer depression symptoms compared to those with nonanxious depression at days @ through @ , @ through @ , @ through @ , and @ , with no significant group differences in dissociative ( P = @ ) or psychotic ( P = @ ) side effects .


Regarding responders , patients with anxious depression relapsed significantly later than those with nonanxious depression ( median SE = @ @ vs @ @ days to relapse , respectively ; = @ ; P = @ ) .


Unexpectedly , patients with anxious depression responded better to ketamine than those with nonanxious depression , with longer time to relapse and no side effect differences .


This finding gives promise for the role of novel glutamatergic medications for the treatment of those with anxious depression , a traditionally difficult-to-treat subgroup of depressed patients .


To perform a deterministic cost-utility analysis , from a @-year societal perspective , of two treatment programs for stress urinary incontinence ( SUI ) without face-to-face contact : one Internet-based and one sent by post .


The treatments were compared with each other and with no treatment .


We performed this economic evaluation alongside a randomized controlled trial .


The study included @ women aged @-@ , with SUI@time/week , who were randomized to @ months of pelvic floor muscle training via either an Internet-based program including e-mail support from an urotherapist ( n = @ ) or a program sent by post ( n = @ ) .


Recruitment was web-based , and participants were self-assessed with validated questionnaires and @-day bladder diaries , supplemented by a telephone interview with a urotherapist .


Treatment costs were continuously registered .


Data on participants ' time for training , incontinence aids , and laundry were collected at baseline , @ months , and @ year .


We also measured quality of life with the condition-specific questionnaire ICIQ-LUTSqol , and calculated the quality-adjusted life-years ( QALYs ) gained .


Baseline data remained unchanged for the no treatment option .


Sensitivity analysis was performed .


Compared to the postal program , the extra cost per QALY for the Internet-based program ranged from @ to @,@ , indicating greater QALY-gains at similar or slightly higher costs .


Compared to no treatment , the extra cost per QALY for the Internet-based program ranged from @,@ to @,@ , indicating greater QALY-gains at higher , but probably acceptable costs .


An Internet-based treatment for SUI is a new , cost-effective treatment alternative .


Vitamin D has immunomodulatory effects in multiple sclerosis ( MS ) .


Vitamin D acts through various mechanisms such as secretion of cytokines .


Interleukin-@ ( IL-@ ) is a critical interleukin in inflammatory response in MS.


This study assessed the effect of oral high dose vitamin D intake on IL-@ levels in MS patients in a double blind randomized clinical trial .


@ patients with a diagnosis of relapsing remitting multiple sclerosis ( RRMS ) were randomized to two groups .


One group received @,@ IU vitamin D@ every five days for @weeks .


The other group was given placebo .


Both groups received interferon - ( IFN - ) treatment .


Serum levels of IL-@ were measured at the beginning of the study and after @weeks .


IL-@ serum levels were @ pg/ml and @ pg/ml in the intervention and placebo group at the beginning of the study , respectively ( MedianIQR , p = @ ) .


After @weeks , IL-@ levels were @ pg/ml and @ pg/ml in the intervention and placebo group , respectively ( MedianIQR , p = @ ) .


The multiple linear regression analysis indicated that the consumption of vitamin D@ was positively and significantly associated with the logarithm of IL-@ measures ( = @ ; p = @ and R@ = @ ) , adjusted by EDSS scores .


IL-@ levels showed significant change in RRMS patients after receiving high dose vitamin D@ for @weeks .


To assess the efficacy of securing conjunctival autograft ( CAG ) without glue or sutures , using the patient 's own blood at the surgical site , and to compare it with the current accepted standard of using fibrin glue for graft adherence , in pterygium surgery .


A single-centre , prospective , randomised controlled trial was carried out in @ eyes of patients with primary pterygia who were advised pterygium excision with CAG .


Enrolled participants were assigned to Group I or II by randomisation .


After excision of pterygium , they underwent CAG with autologous blood in Group I ( @ eyes ) and CAG with fibrin glue in Group II ( @ eyes ) .


During follow-up of @ year , the eyes were assessed for graft adherence and recurrence .


Of the @ eyes randomised , @ eyes that did not complete intended follow-up were excluded from final analysis .


Of the @ eyes ( Group I n = @ , Group II n = @ ) , on the first postoperative day , @ eyes in Group I ( @ % ) had total graft dislodgement requiring regrafting from another site or reattachment with glue .


In Group II also @ eyes ( @ % ) had graft dislodgement on the first postoperative day requiring regrafting from another site .


During the @-year follow-up , @ eyes in Group I ( @ % ) and @ eyes in Group II ( @ % ) developed recurrence .


Feasibilty of adherence of the graft without glue in pterygium surgery is promising and has results comparable with the fibrin glue technique in terms of long-term outcome and recurrence , suggesting the potential for autologous blood to replace fibrin glue in graft fixation .


The physiological changes that occur during pregnancy , including increased blood volume and cardiac output , can affect hemodynamic control , most profoundly with positional changes that affect venous return to the heart .


By using Osteopathic Manipulative Treatment ( OMT ) , a body-based modality theorized to affect somatic structures related to nervous and circulatory systems , we hypothesized that OMT acutely improves both autonomic and hemodynamic control during head-up tilt and heel raise in women at @ weeks gestation .


One hundred subjects were recruited at @ weeks gestation .


The obstetric clinics of UNTHealth in Fort Worth , TX .


Subjects were randomized into one of three treatment groups : OMT , placebo ultrasound , or time control .


Ninety subjects had complete data ( N = @ , @ and @ in each group respectively ) .


Blood pressure and heart rate were recorded during @ min of head-up tilt followed by @ min of intermittent heel raising .


No significant differences in blood pressure , heart rate or heart rate variability were observed between groups with tilt before or after treatment ( p > @ ) , and heart rate variability was not different between treatment groups ( p > @ ) .


However , blood pressure increased significantly ( p = @ ) and heart rate decreased ( p < @ ) during heel raise after OMT compared to placebo or time control .


These data suggest that OMT can acutely improve hemodynamic control during engagement of the skeletal muscle pump and this was most likely due to improvement of structural restrictions to venous return .


Chordomas are relatively rare lesions of the bones .


About @ % occur in the sacrococcygeal region .


Surgical resection is still the standard treatment .


Due to the size , proximity to neurovascular structures and the complex anatomy of the pelvis , a complete resection with adequate safety margin is difficult to perform .


A radical resection with safety margins often leads to the loss of bladder and rectal function as well as motoric/sensoric dysfunction .


The recurrence rate after surgery alone is comparatively high , such that adjuvant radiation therapy is very important for improving local control rates .


Proton therapy is still the international standard in the treatment of chordomas .


High-LET beams such as carbon ions theoretically offer biologic advantages in slow-growing tumors .


Data of a Japanese study of patients with unresectable sacral chordoma showed comparable high control rates after hypofractionated carbon ion therapy only .


This clinical study is a prospective randomized , monocentric phase II trial .


Patients with histologically confirmed sacrococcygeal chordoma will be randomized to either proton or carbon ion radiation therapy stratified regarding the clinical target volume .


Target volume delineation will be carried out based on CT and MRI data .


In each arm the PTV will receive @ GyE in @ fractions .


The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R@ resection .


The evaluation is therefore based on the proportion of treatments without Grade @-@ toxicity ( CTCAE , version @ ) up to @ months after treatment and/or discontinuation of the treatment for any reason as primary endpoint .


Local-progression free survival , overall survival and quality of life will be analyzed as secondary end points .


The aim of this study is to confirm the toxicity results of the Japanese data in raster scan technique and to compare it with the toxicity analysis of proton therapy given in the same fractionation .


Using this data , a further randomized phase III trial is planned , comparing hypofractionated proton and carbon ion irradiation .


Alterations in the advanced glycation end-products ( AGE ) - receptor of AGE ( RAGE ) system are linked to several chronic diseases , which may result from vascular damage .


A high circulating level of the pro-inflammatory RAGE-ligand S@A@ , also known as EN-RAGE , is thought to promote while a high level of soluble RAGE ( sRAGE ) is thought to protect against development of atherosclerotic cardiovascular disease ( CVD ) .


We evaluated circulating S@A@ and sRAGE in relation to clinical characteristics , nutritional status , inflammation and mortality risk in chronic kidney disease ( CKD ) Stage @ patients starting on dialysis .


Plasma S@A@ and sRAGE , biomarkers of inflammation and nutritional status , and comorbidities were investigated in @ CKD Stage @ patients -LSB- median age of @ years , @ % men and median glomerular filtration rate ( GFR ) of @ mL/min/@ @ m ( @ ) -RSB- in conjunction with initiation of dialysis therapy .


Associations between mortality risk and S@A@ or sRAGE were assessed after a median follow-up period of @ months .


In addition , for comparative analyses , S@A@ and sRAGE levels were assessed also in @ haemodialysis and @ peritoneal dialysis patients after @ year of dialysis , @ CKD Stages @-@ patients and @ community-based control subjects .


The median level of S@A@ was @-fold higher , median sRAGE @ higher and median ratio S@A@/sRAGE @ times higher in CKD @ patients than in controls .


Similar alterations were observed in CKD @-@ patients ; however , CKD @ patients had a higher median level of sRAGE than the CKD @-@ patients .


In the CKD @ patients , S@A@ levels were higher in those with diabetes or CVD than in those without these comorbidities .


Furthermore , S@A@ correlated with high-sensitivity C-reactive protein ( hsCRP ) levels ( = @ ; P < @ ) and a @-SD higher level of S@A@ associated with increased all-cause mortality risk ( hazard ratio @ , @ % confidence interval @-@ @ ) after adjustment for age , sex , comorbidity , nutritional status and inflammation ( hsCRP ) .


In the CKD @ patients , sRAGE correlated negatively with GFR ( = -@ ; P < @ ) but sRAGE did not associate with hsCRP , comorbidities or mortality .


Plasma concentrations of sRAGE , S@A@ and the ratio S@A@/sRAGE , are markedly elevated in CKD @ patients starting on dialysis as well as in CKD @-@ patients and prevalent dialysis patients suggesting that these alterations are typical for patients with moderate or severe CKD .


In CKD @ patients , an increased concentration of S@A@ are associated with inflammation , comorbidities and increased mortality risk whereas no such associations were observed for sRAGE .


These results suggest that while high plasma S@A@ is an independent predictor of increased mortality risk , sRAGE does not seem to be a valid risk marker in this patient population .


In this study we sought to determine whether a Titin peptide fragment can serve as a clinical biomarker for changes in muscle mass .


Mass spectrometry was used to identify Titin fragment in urine .


An antibody against this Titin sequence was raised and used to develop a competitive ELISA assay for measurement in serum .


Rat tissue extractions in the presence or absence of a series of proteases of interest were used to identify its enzymatic origin .


A rat model of dexamethasone ( DEX ) induced muscle atrophy and a human @-day bed rest study with and without vibration therapy were used to assess biological and clinical relevance .


A technically robust ELISA measuring the Titin fragment was developed against a Titin peptide fragment identified in human urine .


The fragment was shown to be produced primarily by MMP-@ cleavage of Titin .


In the rat muscle DEX induced atrophy model , Titin-MMP@ fragment was decreased in the beginning of DEX treatment , and then significantly increased later on during DEX administration .


In the human bed rest study , the Titin-MMP@ fragment was initially decreased @ ( @ ) % after @day of bed rest , and then gradually increased ending up at a @ ( @ ) % increase at day @ .


We developed a robust ELISA measuring a muscle derived MMP-@ generated Titin degradation fragment in rat and human serum .


Importantly , the fragment can be measured in serum and that these levels are related to induction of skeletal muscle atrophy .


This study compared the effects of short-term titrated colestilan ( a novel non-absorbable , non-calcium , phosphate binder ) with placebo , and evaluated the safety and efficacy of colestilan over @ year compared with sevelamer , in patients with chronic kidney disease ( CKD ) @D .


This prospective multicentre study comprised a @-week phosphate binder washout period , a @-week short-term , flexible-dose , treatment period ( including a @-week placebo-controlled withdrawal period ) and a @-week extension treatment phase .


At Week @ ( the end of the @-week placebo-controlled withdrawal period ) , serum phosphorus level was @ mmol/L ( @ mg/dL ) lower with colestilan than placebo ( P < @ ; primary end point ) .


Serum LDL-C level was also lower with colestilan than with placebo ( P < @ ) .


Both colestilan and sevelamer produced significant reductions from baseline in serum phosphorus levels ( P < @ ) , maintained for @ year , and the proportion of patients achieving target levels of @ mmol/L ( @ mg/dL ) or @ mmol/L ( @ mg/dL ) at study end were similar ( @ and @ % , respectively , for colestilan , and @ and @ % , respectively , for sevelamer ) .


Serum calcium level remained stable in the colestilan group but tended to increase slightly in the sevelamer group ( end-of-study increase of @ mmol/L over baseline ) .


Both binders produced similar reductions from baseline in LDL-C level ( P < @ ) , and responder rates after @ year , using a target of < @ mmol/L ( @ mg/dL ) or < @ mmol/L ( @ mg/dL ) were similar in both groups ( @ and @ % for colestilan and @ and @ % for sevelamer ) .


Colestilan was generally well tolerated .


Colestilan is effective and safe for the treatment of hyperphosphataemia in patients with CKD @D , and affords similar long-term phosphorus and cholesterol reductions/responder rates to sevelamer .


We investigated the association of HIV infection and highly active antiretroviral therapy ( HAART ) with sleep disordered breathing ( SDB ) , fatigue , and sleepiness .


HIV-uninfected men ( HIV - ; n = @ ) , HIV-infected men using HAART ( HIV + / HAART + ; n = @ ) , and HIV-infected men not using HAART ( HIV + / HAART - ; n = @ ) recruited from two sites of the Multicenter AIDS cohort study ( MACS ) underwent a nocturnal sleep study , anthropometric assessment , and questionnaires for fatigue and the Epworth Sleepiness Scale .


The prevalence of SDB in HIV - men was compared to that in men matched from the Sleep Heart Health Study ( SHHS ) .


The prevalence of SDB was unexpectedly high in all groups : @ % for HIV - , @ % for HIV + / HAART + , and @ % for HIV + / HAART - , despite lower body-mass indices ( BMI ) in HIV + groups .


The higher prevalence in the HIV - men was significant in univariate analyses but not after adjustment for BMI and other variables .


SDB was significantly more common in HIV - men in this study than those in SHHS , and was common in participants with BMIs < @ kg/m@ .


HIV + men reported fatigue more frequently than HIV - men ( @ % vs. @ % ; p = @ ) , but self-reported sleepiness did not differ among the three groups .


Sleepiness , but not fatigue , was significantly associated with SDB .


SDB was highly prevalent in HIV - and HIV + men , despite a normal or slightly elevated BMI .


The high rate of SDB in men who have sex with men deserves further investigation .


Sleepiness , but not fatigue , was related to the presence of SDB .


Clinicians caring for HIV-infected patients should distinguish between fatigue and sleepiness when considering those at risk for SDB , especially in non-obese men .


To compare the efficacy of percutaneous sodium tetradecyl sulfate ( STS ) injection with ethanol injection in the treatment of benign nonfunctioning thyroid nodules .


This prospective study included @ patients with @ benign thyroid nodules .


The lesions were randomly assigned into two groups : @ in the ethanol arm and @ in the STS arm .


The mean lesion volume was @ mL @ ( range , @-@ @ mL ) in the ethanol arm and @ mL @ ( range , @-@ mL ) in the STS arm .


One sitting of sclerosant injection was done in @ lesions , and two injections , three injections , four injections , five injections , six injections , seven injections , and eight sittings of injections were done in @ lesions , @ lesions , @ lesions , @ lesions , @ lesions , @ lesions , and @ lesion .


The mean volumes of the instilled ethanol and STS were @ mL and @ mL , respectively , per sitting .


Follow-up sonography was performed at @ , @ , @ , and @ months after the procedure .


The final @-month follow-up lesion volumes were @ mL @ ( range , @-@ @ mL ) in the ethanol group and @ mL @ ( range , @-@ @ mL ) in the STS group ( P = @ ) .


The mean volume reduction was @ % and @ % in the two groups .


No significant adverse effects were seen in either of the two groups .


Sonographically guided percutaneous ethanol and STS injections are not significantly different from each other in terms of the volume reduction achieved in benign nonfunctioning thyroid nodules .


Parathyroid hormone ( PTH ) promotes calcium reabsorption in the cortical distal nephron ( CDN ) .


The phosphate concentration ( -LSB- P -RSB- f ) rises in that segment in chronic kidney disease ( CKD ) ; in theory , high -LSB- P -RSB- f could reduce availability of calcium for reabsorption and necessitate a compensatory rise in -LSB- PTH -RSB- .


With assumptions , -LSB- P -RSB- f is proportional to phosphate excreted/volume of filtrate ( EP/GFR ) .


We therefore hypothesized that -LSB- PTH -RSB- would correlate with EP/GFR in CKD , and PTH -RSB- would correlate with EP/GFR after sevelamer therapy .


We conducted a @-week , placebo-controlled trial of sevelamer carbonate in patients with CKD .


-LSB- PTH -RSB- @-@ and parameters of phosphate homeostasis were measured before and after treatment .


GFR was assumed to equal creatinine clearance ( Ccr ) .


Pertinent linear regressions were performed .


Phosphate excretion fell in the sevelamer group only .


Decrements in -LSB- PTH -RSB- with sevelamer differed from increments with placebo .


With either treatment , -LSB- PTH -RSB- correlated with EP/Ccr and PTH -RSB- correlated with EP/Ccr .


Changes in -LSB- PTH -RSB- were minimal in some sevelamer recipients despite reductions in EP/Ccr ; calcium excreted/volume of filtrate was low in these subjects .


Phosphate influx affected -LSB- PTH -RSB- in CKD by determining -LSB- P -RSB- f in the CDN .


In some patients , low calcium influx may have blunted the effect of sevelamer on -LSB- PTH -RSB- .


In a previous uncontrolled experiment , oral vancomycin improved the symptoms ( S ) of chronic constipation ( CC ) .


The aim of this @ day controlled pilot study was to determine if a low lincomycin dose improved the S of CC patients unresponsive to a high fiber diet .


On days @-to-@ , patients were randomized to @ mg oral lincomycin + high fiber ( L + F ) or to placebo + high fiber ( P + F ) .


Participants and patients were blinded .


From days @-to-@ , patients were continued solely on the high fiber diet .


The primary efficacy endpoint was the difference in S between L + F and P + F from days @-to-@ using a visual analog scale ( VAS ) calibrated from @ = severe S to @ = asymptomatic .


The means of all S were significantly improved by L + F but not by P + F.


A significant higher proportion of L + F patients increased the VAS > or = @ points .


The initial course of L facilitated the effect of F probably by its effect on the colon flora .


This sequence of flora-altering biologics + F may serve as model to replace chronic use of drugs .


We explored the differential effect of cessation interventions ( behavioral support sessions with -LSB- BSS + -RSB- and without -LSB- BSS -RSB- bupropion ) between hookah and cigarette smokers .


We reanalyzed the data from a major cluster-randomized controlled trial , ASSIST ( Action to Stop Smoking In Suspected Tuberculosis ) , which consisted of @ conditions : ( a ) behavioral support sessions ( BSS ) , ( b ) behavioral support sessions plus @ weeks of bupropion therapy ( BSS + ) , and ( c ) controls receiving usual care .


The trial originally recruited @,@ adult smokers with suspected tuberculosis from @ health centers in the Jhang and Sargodha districts of Pakistan between @ and @ .


The primary endpoint was continuous @-month smoking abstinence , which was determined by carbon monoxide levels .


Subgroup-specific relative risks ( RRs ) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression ( generalized linear model ) between @ subgroups ( cigarette-only : @,@ ; mixed : @ ; and hookah-only : @ ) .


The test result for homogeneity of intervention effects between the smoking forms was statistically significant ( p-value for BSS + : @ and for BSS : @ ) .


Compared to the control , both interventions appeared to be effective among hookah smokers ( RR = @ ; @ % CI = @-@ @ and RR = @ ; @ % CI = @-@ @ , respectively ) but less effective among cigarette smokers ( RR = @ ; @ % CI = @-@ @ and RR = @ ; @ % CI = @-@ @ ) , respectively .


The differential intervention effects on hookah and cigarette smokers were seen ( a ) because the behavioral support intervention was designed primarily for cigarette smokers ; ( b ) because of differences in demographic characteristics , behavioral , and sociocultural determinants ; or ( c ) because of differences in nicotine dependency levels between the @ groups .


To observe the effect of the Traditional Chinese Medicine , modified Taohongsiwu decoction , versus pyridoxine on patients with hand-foot syndrome ( HFS ) from capecitabine , sorafenib , and gefitinib chemotherapy for gastric , lung , breast , colon , or rectal cancer .


Also , to compare quality of life of patients in each group .


Patients were assigned randomly to group A or B. Group A was given modified Taohongsiwu decoction to soak hands and feet for @ min , once daily .


Group B was given @ mg pyridoxine orally , twice daily .


After a @-week treatment , the therapeutic effect was assessed by observing three major symptoms , including pain , ulceration , and muscular atrophy .


This was assessed with the HFS-@ questionnaire .


Significant differences were observed between the two groups in pain relief , and improvement of daily life , walking , and interpersonal communication ( P < @ ) .


No significant differences in driving ability or interpersonal relationships were found .


After @ weeks , the effective rate was @ % in group A , which was significantly higher than the @ % in group B ( P = @ ) .


Modified Taohongsiwu decoction is effective in the treatment of patients with HFS .


It improves patients ' quality of life according to the HFS-@ .


To evaluate the preemptive analgesia effects of both the parecoxib sodium and the pentazocine in patients undergoing nasal endoscopic surgery .


In the randomized , double blind , controlled study , @ patients undergoing septoplasty were divided into @ groups ( n = @ ) : group A received parecoxib @ mg by muscle injection @ min before the operation ; group B received pentazocine @ mg ; group C received an equal volume of saline .


The preemptive analgesia effect was evaluated with VAS scores which recorded at different time points .


The proportion of participants using rescue analgesia after the operation were recorded as additional measures of preemptive analgesia .


Intra-operative as well as the postoperative pain scores were less in the group A and group B than in the control group .


Fewer participants required rescue medication after operation with parecoxib as well as pentazocine than placebo .


However there were no difference in the preemptive effects between the group A and group B.


Administration of both the parecoxib and pentazocine before the nasal endoscopic surgery can provide preemptive analgesia without serious adverse side effects that deserves popularization in the clinic .


A recent phase III randomized controlled trial ( NCT@ ) showed efficacy of pasireotide in the treatment of patients with Cushing 's disease ( CD ) .


Patients were invited to participate in an extension phase of the protocol and a subgroup had a sustained response .


We report the experience with @ patients in our center of which @ full responders have completed @ and @ years of treatment with disease control .


The trial protocol was described previously .


The extension phase consisted of @-monthly visits with clinical , biochemical , and imaging evaluation and investigator-driven pasireotide titration .


Research charts were retrospectively analyzed .


Four patients with persistent CD following pituitary surgery completed the first @ months of the trial and @ continued in the next @ month open-label phase .


Two patients with baseline urinary free cortisol ( UFC ) @-@ @ times the upper limit of normal had a rapid sustained response to pasireotide and entered the extension phase after @ months .


They remain in clinical and biochemical disease remission and @ patient now only requires @ g daily of pasireotide .


All @ patients developed glucose intolerance ; however , the two patients in the extension phase were eventually able to discontinue all diabetes pharmacotherapy .


Adverse events included second degree atrioventicular block type @ without QT prolongation in a patient with pre-existing sinus bradycardia , and symptomatic cholelithiasis requiring cholecystectomy in a second patient .


Pasireotide therapy can provide normalization of UFC and of clinical symptoms and signs of CD during up to @ years of follow-up .


This study demonstrates the possible recuperation of normoglycemia after continued use of pasireotide and control of underlying hypercortisolemia .


Longer-term monitoring for potential adverse events related to continued use of pasireotide is indicated .


Low molecular weight heparins ( LMWHs ) constitute the mainstay of anticoagulant therapy for pediatric venous thromboembolism ( VTE ) .


The safety and effectiveness of dalteparin , an LMWH , has not been established in children , and pediatric data on dalteparin for VTE are limited to one single-center experience .


To establish dose-finding ( primary endpoint ) and efficacy/safety outcomes ( secondary endpoints ) in children treated with dalteparin in a substudy of the Kids-DOTT trial .


A prospective multicenter trial using dalteparin subcutaneously twice daily for acute VTE in children aged @ years was conducted under an investigator-held Investigational New Drug application registered with the US Food and Drug Administration .


Initial weight-based dosing per protocol was as follows : infants ( < @ months ) , @ IU kg ( -@ ) ; children ( @-@ years ) , @ IU kg ( -@ ) ; and adolescents ( @-@ years ) , @ IU kg ( -@ ) .


Bleeding events were categorized according to ISTH criteria .


Descriptive non-parametric statistics were employed for all analyses .


Eighteen patients ( @ % male ) were enrolled from January @ to October @ across four centers .


No supratherapeutic levels were observed .


Median ( range ) therapeutic doses by age group were as follows : infants ( n = @ ) , @ IU kg ( -@ ) ( @-@ IU kg ( -@ ) ) ; children ( n = @ ) , @ IU kg ( -@ ) ( @-@ IU kg ( -@ ) ) ; and adolescents ( n = @ ) , @ IU kg ( -@ ) ( @-@ IU kg ( -@ ) ) .


The median duration of dalteparin use was @ days ( range : @-@ days ) , and the median follow-up was @ months ( range : @-@ months ) .


There were no related serious adverse events , no clinically relevant bleeding events , and no symptomatic recurrent VTEs .


Dalteparin successfully achieved targeted anti-factor Xa levels in @ children and young adults with acute VTE with a standardized age-based dosing regimen , with a favorable safety and efficacy profile .


Pulmonary rehabilitation has been demonstrated to improve exercise capacity , dyspnoea , quality of life and to reduce the adverse effects of acute exacerbations .


Current guidelines recommend exercise training in patients with mild to very severe disease .


However , there is insufficient data comparing the efficacy of different training approaches and intensities .


Between January @ and December @ , @ COPD patients were screened to participate in the study .


@ patients were randomly assigned into an individualized training group or into a non-individualized training group .


Both groups exercised once a week for @minutes over a time period of three months .


At the beginning and after three months , the following measurements were performed : @-minute walking test ( @-MWT ) , health-related quality of life ( St. Georges Respiratory Questionnaire ; SGRQ and COPD-Assessment-Test ; CAT ) , M. rectus femoris cross-sectional area , and inflammatory markers in peripheral blood .


Only in the individualized training group we observed a significant change of the @-MWT ( increase of @ m ; p = @ ) and the cross-sectional area of the M. rectus fermoris ( increase of @ cm@ ; p = @ ) , while no significant changes occurred in the non-individualized training group .


Peroxisome-proliferator-activated receptor - coactivator @ increased in the individualized training only after the three months training period ( increase of @ relative copies ; p = @ ) , all other myokines and inflammatory markers were not influenced by either of the programs .


The total drop-out-rate was @ % .


A low frequency outpatient training program may induce modest improvements in exercise capacity and muscle mass only if it is performed on an individualized basis .


To determine the DA and cost-effectiveness of the dermoscope in primary care for skin lesions suspected of malignancy .


In a cluster randomized clinical trial , @ Dutch general practices were randomized to either intervention group using a dermoscope or control group using only naked-eye examination .


A total of @ lesions from @ patients in the intervention group and @ lesions from @ patients in the control group were analysed for DA and cost-effectiveness .


The percentage of correctly diagnosed lesions in intervention group and control group was @ % and @ % respectively .


This was @ % and @ % for melanomas .


In the intervention group , three malignancies were treated with the expectative treatment option compared to none in the control group .


The odds ratio ( OR ) of a correct diagnosis in the intervention group , compared to control group , was @ ( @ % CI : @ ) P = @ .


Consequently , the relative risk was @ .


The incremental cost-effectiveness ratio was @ ( @ % CI @ to @ ) , indicating that using a dermoscope costs an additional @ for one additional correctly diagnosed patient .


Additional analyses showed better effects of dermoscopy compared to the control group for @ % of the bootstrap resamples .


The probability of a correct diagnosis was @ times higher using a dermoscope than without a dermoscope .


Although this difference is marginally not statistically significant , dermoscopy in general practice appears to be cost effective .


We therefore think that GPs should be trained to use a dermoscope , although they should realize that even with the use of a dermoscope not all lesions will be diagnosed correctly .


Elevated polyclonal serum immunoglobulin free light chains ( FLCs ; combined FLC+FLC -LSB- cFLC -RSB- ) are associated with adverse clinical outcomes and increased mortality ; we investigated cFLC and cardiovascular disease ( CVD ) events in type @ diabetes .


In a cohort study of @ south Asian patients with type @ diabetes , serum cFLC , high-sensitivity C-reactive protein ( hsCRP ) , and standard biochemistry were measured .


CVD events over @ years were recorded and assessed using multiple logistic regression .


cFLC levels were elevated significantly in @ of @ ( @ % ) patients with CVD events during @ years of follow-up ( @ vs. @ mg/L ; P = @ ) .


In multivariate analysis , elevated cFLC ( > @ mg/L ) was associated with CVD outcomes ( odds ratio @ -LSB- @ % CI @-@ @ -RSB- ; P = @ ) and remained significant after adjusting for age , albumin-to-creatinine ratio , diabetes duration , or treatment .


cFLC elevation is a novel marker for CVD outcomes in type @ diabetes that warrants further investigation .


The aim of this study was to evaluate the survival and success of screw-retained versus cement-retained implant restorations in immediately loaded implants at @-year follow-up .


Patients who were scheduled for full-arch ceramic prosthetic restorations were divided into two groups by randomization : in one group , prosthetic frameworks were screwed onto implants ( screw-retained group , SRG ) , and in the second group , the frameworks were cemented on abutments ( cement-retained group , CRG ) .


Dental implants were placed both in postextraction and in healed sites .


A temporary full-arch prosthesis was placed immediately after implant placement .


Intraoral digital radiographic examinations ( evaluating marginal bone levels ) were made at baseline , @ months , and each year after implant placement .


In @ patients , @ full arches and @ implants were placed in the maxilla and @ full arches and @ implants in the mandible ( @ rehabilitations in each group ) .


After an @-year follow-up period , a survival rate of @ % was reported for all implants .


Within the first year after implant placement , bone loss was recorded as follows : the CRG showed mean bone levels of -@ @ mm , while the SRG showed mean bone levels of -@ @ mm .


After a @-year follow-up , a slight increase was found ( @ @ mm in CRG and @ @ mm in SRG ) .


After that point , marginal bone levels remained stable over time , up to the @-year follow-up .


No statistically significant differences were found between groups ( P > @ ) .


Definitive cement - and screw-retained ceramic restorations are highly predictable , biocompatible , and esthetically pleasing , and the two groups presented no statistically significant differences in bone loss .


Social anxiety disorder ( SAD ) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide .


Although effective treatments are available , a lot of cases go untreated .


Internet-based self-help is a low-threshold and flexible treatment alternative for SAD .


Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly .


Most of the interventions tested include therapist support , whereas the role of peer support within internet-based self-help has not yet been fully understood .


There is evidence suggesting that patients ' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments .


This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD .


The study is conducted as a randomized controlled trial .


A total of @ adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions .


The participants in the two active conditions use the same internet-based self-help program , either with individual support by a psychologist or therapist-guided group support .


In the group guided condition , participants can communicate with each other via an integrated , protected discussion forum .


Subjects are recruited via topic related websites and links ; diagnostic status will be assessed with a telephone interview .


The primary outcome variables are symptoms of SAD and diagnostic status after the intervention .


Secondary endpoints are general symptomology , depression , quality of life , as well as the primary outcome variables @ months later .


Furthermore , process variables such as group processes , the change in symptoms and working alliance will be studied .


The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD .


This novel treatment format , if shown effective , could represent a cost-effective option and could further be modified to treat other conditions , as well .


This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients .


A single-blinded randomized controlled trial and mixed-method design were used .


Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment .


They were randomly assigned to the intervention group , in which a psychoeducational intervention program based on a thematic counseling model was offered , or to the attention control group .


Quantitative data on sexual functioning , quality of life , uncertainty , anxiety , depression and social support were collected at recruitment , post-operative and during the in-hospital period , and eight weeks after the operation .


Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews .


Of the @ eligible subjects , @ were successfully recruited into the study .


Following the psychoeducational intervention program , there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group .


In addition , trends towards improvement were demonstrated in quality of life , uncertainty , depression and perceived social support with the provision of the interventions .


Qualitative data indicated the interventions were desired and appreciated by the participants , as well as being feasible and practical to implement in Hong Kong clinical settings .


The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients .


A full-scale study is warranted to confirm the results .


The objectives of this study were ( @ ) to investigate the effect of nurse training on the use of potentially harmful medications ; and ( @ ) to explore the effect of nurse training on residents ' health-related quality of life ( HRQoL ) , health service utilization , and mortality .


A randomized controlled trial .


In total , @ residents in @ wards of assisted living facilities in Helsinki were recruited .


The @ wards were randomized into those in which ( @ ) staff received two @-hour training sessions on appropriate medication treatment ( intervention group ) , and ( @ ) staff received no additional training and continued to provide routine care ( control group ) .


Two @-hour interactive training sessions for nursing staff based on constructive learning theory to recognize potentially harmful medications and corresponding adverse drug events .


Use of potentially harmful medications , HRQoL assessed using the @ dimensional instrument of health-related quality of life , health service utilization , and mortality assessed at baseline , and @ and @ months .


During the @-month follow-up , the mean number of potentially harmful medications decreased in the intervention wards -LSB- -@ , @ % confidence interval ( CI ) -@ to -@ -RSB- but remained constant in the control wards ( +@ , @ % CI -@ to +@ ) ( P = @ , adjusted for age , sex , and comorbidities ) .


HRQoL declined more slowly in the intervention wards ( -@ ( @ % CI -@ to -@ ) than in the control wards ( -@ ( @ % CI -@ to -@ ) ( P = @ , adjusted for age , sex , and comorbidities ) .


Residents of the intervention wards had significantly less hospital days ( @ days/person/year , @ % CI @-@ @ ) than in the control wards ( @ days/person/year ; @ % CI @-@ @ ) ( relative risk @ , @ % CI @-@ @ , P < @ , adjusted for age , sex , and comorbidities ) .


Activating learning methods directed at nurses in charge of comprehensive care can reduce the use of harmful medications , maintain HRQoL , and reduce hospitalization in residents of assisted living facilities .


Nontargeted metabolite profiling allows for concomitant examination of a wide range of metabolite species , elucidating the metabolic alterations caused by dietary interventions .


The aim of the current study was to investigate the effects of dietary modifications on the basis of increasing consumption of whole grains , fatty fish , and bilberries on plasma metabolite profiles to identify applicable biomarkers for dietary intake and endogenous metabolism .


Metabolite profiling analysis was performed on fasting plasma samples collected in a @-wk parallel-group intervention with @ participants with features of metabolic syndrome who were randomly assigned to @ dietary interventions : @ ) whole-grain products , fatty fish , and bilberries -LSB- healthy diet ( HD ) -RSB- ; @ ) a whole-grain-enriched diet with the same grain products as in the HD intervention but with no change in fish or berry consumption ; and @ ) refined-wheat breads and restrictions on fish and berries ( control diet ) .


In addition , correlation analyses were conducted with the food intake data to define the food items correlating with the biomarker candidates .


Nontargeted metabolite profiling showed marked differences in fasting plasma after the intervention diets compared with the control diet .


In both intervention groups , a significant increase was observed in @ signals identified as glucuronidated alk ( en ) - ylresorcinols -LSB- corrected P value ( Pcorr ) < @ -RSB- , which correlated strongly with the intake of whole-grain products ( r = @ , P < @ ) .


In addition , the HD intervention increased the signals for furan fatty acids -LSB- @-carboxy-@-methyl-@-propyl-@-furanpropionic acid ( CMPF ) -RSB- , hippuric acid , and various lipid species incorporating polyunsaturated fatty acids ( Pcorr < @ ) .


In particular , plasma CMPF correlated strongly with the intake of fish ( r = @ , P < @ ) but not with intakes of any other foods .


Novel biomarkers of the intake of health-beneficial food items included in the Nordic diet were identified by the metabolite profiling of fasting plasma and confirmed by the correlation analyses with dietary records .


The one with the most potential was CMPF , which was shown to be a highly specific biomarker for fatty fish intake .


This trial was registered at clinicaltrials.gov as NCT@ .


Previous studies have found that family-based psychosocial treatments are effective adjuncts to pharmacotherapy among adults and adolescents with bipolar disorder ( BD ) .


The objective of this study was to compare the efficacy of adjunctive child - and family-focused cognitive-behavioral therapy ( CFF-CBT ) to psychotherapy as usual ( control ) for mood symptom severity and global functioning in children with BD .


Sixty-nine youth , aged @ to @ years ( mean = @ , SD = @ ) with DSM-IV-TR bipolar I , II , or not otherwise specified ( NOS ) disorder were randomly assigned to CFF-CBT or control groups .


Both treatments consisted of @ weekly sessions followed by @ monthly booster sessions delivered over a total of @months .


Independent evaluators assessed participants at baseline , week @ , week @ , week @ ( posttreatment ) , and week @ ( @-month follow-up ) .


Participants in CFF-CBT attended more sessions , were less likely to drop out , and reported greater satisfaction with treatment than controls .


CFF-CBT demonstrated efficacy compared to the control treatment in reducing parent-reported mania at posttreatment and depression symptoms at posttreatment and follow-up .


Global functioning did not differ at posttreatment but was higher among CFF-CBT participants at follow-up .


CFF-CBT may be efficacious in reducing acute mood symptoms and improving long-term psychosocial functioning among children with BD .


Antioxidants effectiveness in prostate cancer ( PCa ) chemoprevention has been severely questioned , especially after the recent results of the Selenium and Vitamin E Cancer Prevention Trial .


We present the results of a double-blind randomized controlled trial ( dbRCT ) on the pharmacokinetic , clinical , and molecular activity of dietary supplements containing lycopene , selenium , and green tea catechins ( GTCs ) in men with multifocal high grade prostatic intraepithelial neoplasia ( mHGPIN ) and/or atypical small acinar proliferation ( ASAP ) .


From @ to @ , we conducted a dbRCT including @ patients with primary mHGPIN and/or ASAP receiving daily lycopene @mg , selenium @g , and GTCs @mg , or placebo for @ months .


Pharmacokinetic analysis were performed with UV-Visible spectrophotometric assay under standard ( SC ) and accelerated ( AC ) conditions .


Upon plasma lycopene concentrations falling within the expected range ( @-@mcg / l ) and no side-effects of grade > @ , study proceeded to phase II ( n = @ ) .


After unblinding of results , eight men ( @ per arm , @ without and @ with PCa , respectively ) were randomly selected and totRNA extracted from `` non-pathological '' tissues .


MicroRNA profiling was performed with the Agilent platform .


Raw data processing used R-statistical language and linear models for microarray analysis .


Samples were stable except for lycopene , showing significant degradation ( SC = @ % , AC = @ % ) and consequently stabilized under vacuum in a dark packaging .


Mean plasmatic lycopene concentration was @,@,@ M.


At @ months , @ men underwent re-biopsy and @ ( @ % ) were diagnosed with PCa ( supplementation n = @ , placebo n = @ -LSB- P = @ -RSB- ) .


At a mean @ months follow-up , @ additional PCa were found in the placebo group .


No significant variations in PSA , IPSS , and PR@ questionnaires were observed .


Stronger modulation of miRNAs was present on re-biopsy in the supplementation group compared to the placebo , including : ( i ) overexpression of miRNAs present in PCa versus non-cancer tissue ; ( ii ) underexpression of miRNAs suppressing PCa proliferation ; ( iii ) detection of @ miRNAs in PCa patients versus disease-free men , including androgen-regulated miR-@b-@p and PTEN-targeting miR-@a-@p ( both upregulated ) .


Administration of high doses of lycopene , GTCs , and selenium in men harboring HGPIN and/or ASAP was associated with a higher incidence of PCa at re-biopsy and expression of microRNAs implicated in PCa progression at molecular analysis .


The use of these supplements should be avoided .


Diabetes self-management education ( DSME ) is recommended for all patients with diabetes .


Current estimates indicate that < @ % of patients receive DSME , increasing risk for hospitalization which occurs more frequently with diabetes .


Hospitalization presents opportunities to provide DSME , potentially decreasing readmissions .


To address this , we investigated the feasibility of providing DSME to inpatients with diabetes .


Patients hospitalized on four medicine units were randomized to receive DSME ( Education Group ) ( n = @ ) prescribed by a certified diabetes educator and delivered by a registered nurse , or Usual Care ( n = @ ) .


Participants completed Diabetes Knowledge Tests ( DKT ) , Medical Outcomes Short Form ( SF-@ ) , Diabetes Treatment Satisfaction Questionnaire ( DTSQ ) , and the DTSQ-inpatient ( DTSQ-IP ) .


Bedside capillary blood glucoses ( CBG ) on day of admission , randomization and discharge were compared .


There were no group differences in demographics , diabetes treatment , admission CBG ( @ mg/dL vs. @ mg/dL , p = @ ) , DKT scores ( Education vs. Usual Care @ vs. @ , p = @ ) , SF-@ , and DTSQ scores ( @ vs. @ , p = @ ) .


Patients receiving education reported more satisfaction with inpatient treatment ( @ vs. @ , p = @ ) , less hyperglycemia prior to ( @ vs. @ , p = @ ) and during hospitalization ( @ vs. @ , p = @ ) ; and had lower mean discharge CBG ( @ mg/dL vs. @ mg/dL , p = @ ) .


Inpatient diabetes education has potential to improve treatment satisfaction , and reduce CBG .


A direct renin inhibitor ( DRI ) , aliskiren , may be effective for blood pressure ( BP ) control in hemodialysis patients .


However , it is unclear whether aliskiren has a greater beneficial effect on BP and humoral factors than angiotensin II receptor antagonists ( ARBs ) in hypertensive patients on hemodialysis .


Eighteen hemodialysis patients ( @ @ years ) on the recommended dose of an ARB were prospectively randomized into two groups : ARB and DRI groups .


Patients in the ARB group continued taking their previous ARB , whereas those in the DRI group switched to aliskiren ( @ mg/day ) for @ weeks .


Baseline measurements of BP and humoral factors such as plasma renin activity ( PRA ) , plasma aldosterone concentration ( PAC ) and brain natriuretic peptide ( BNP ) were performed .


Measurements were repeated every @ weeks .


At baseline , no differences were observed in age , gender or BP between the two groups .


Systolic BP was unaffected by treatment in either groups ( group effect , p = @ ; time effect , p = @ ; group time effect , p = @ ) .


PRA decreased in DRI ( p @ , group effect , p = @ ; time effect , p = @ ; group time effect , p = @ ) , but not in ARB ( p @ ) .


PAC increased only in DRI ( p @ ) , whereas BNP was unaffected in either group .


Aliskiren at a dose of @ mg/day had a similar effect on BP compared with ARBs , but significantly lowered PRA .


Irritable bowel syndrome ( IBS ) is a chronic gastrointestinal ( GI ) disorder that affects @-@ % of the Western population .


There are currently few therapeutic options available for the treatment of IBS .


The aim of this study is to evaluate the efficacy and the safety of a medical device containing a combination of Simethicone and Bacillus coagulans in the treatment of IBS .


This is a monocentric double-blind , placebo-controlled parallel group clinical trial .


Adult subjects suffering from IBS as defined by Rome III criteria were enrolled .


Bloating , discomfort , abdominal pain were assessed as primary end point .


Subjects received the active treatment or placebo @ time a day after each meal for @ weeks of study period .


Subjects were submitted to visit at Day @ ( T@ ) , at Days @ ( T@ ) and @ ( T@ ) .


Fifty-two patients were included into the study .


Intragroup analysis showed a significant reduction of the bloating , discomfort and pain in Colinox group ( CG ) compared to placebo group ( PG ) .


Between group analysis confirmed , at T@-T@ , significant differences between CG and PG in bloating and discomfort .


Simethicone is an inert antifoaming able to reduce bloating , abdominal discomfort .


Literature offers increasing evidence linking alterations in the gastrointestinal microbiota and IBS and it is well known that probiotics are important to restore the native gut microbiota .


The Colinox medical device is specifically targeted against most intrusive symptom of IBS ( bloating ) and it is also able to counteract the most accredited ethiopathogenetic factor in IBS ( alterations of intestinal microbiota ) .


This is the first randomized double-blind placebo-controlled clinical trial demonstrating the efficacy and safety of a combination of simethicone and Bacillus coagulans in treatment of IBS .


It is widely agreed that chronic depression is difficult to treat , knowledge about optimal treatment approaches is emerging .


A multisite randomized controlled trial was conducted comparing the cognitive behavioral analysis system of psychotherapy ( CBASP ) , a psychotherapy model developed specifically to treat chronic depression ( n = @ ) with care as usual ( CAU ; evidence-based treatments , n = @ ) over a period of @ weeks , with @ sessions on average , in @ outpatient clinics in the Netherlands .


In both arms algorithm-based pharmacotherapy was provided .


Patients ( aged @-@ ) met criteria for a DSM-IV diagnosis of major depressive disorder with diagnostic specifiers ( chronic , without interepisode recovery ) or with co-occurring dysthymic disorder indicating a chronic course .


The Inventory for Depressive Symptomatology ( IDS ) Self-Report was used as the primary outcome measure .


Mixed-effects linear regression analysis was used to compare the changes on the IDS scores between CBASP and CAU .


The IDS was administered before treatment , and after @ , @ , @ and @ weeks .


At week @ , patients assigned to CBASP had a greater reduction of depressive symptoms compared to patients assigned to CAU ( t = -@ , p = @ ) .


However , CBASP and CAU did not differ from each other on the IDS after @ weeks ( t = @ , p = @ ) , @ weeks ( t = -@ , p = @ ) and @ weeks ( t = -@ , p = @ ) of treatment .


This trial shows that CBASP is at least as effective as standard evidence-based treatments for chronic depression .


In the long run , CBASP appears to have an added effect .


To evaluate feasibility and superiority of large liver hemangioma treated with laparoscopic microwave ablation .


Between March @ and May @ , @ patients with liver hemangioma ( @-@ cm ) were surgically treated in our department , and were randomly divided into three groups , laparoscopic microwave ablation group ( treatment group ) , traditional opening group , and laparoscopic resection group .


Three groups were compared in respect of postoperative ambulation time , gastrointestinal function recovery time , postoperative liver function recovery time , intraoperative blood loss , postoperative hospital stay , using SPSS@ @ software and analysis of variance , P < @ indicates significant , then adopting Student-Newman-Keuls method to compare mean value of every two groups .


And the treatment group of patients were tracked and reviewed .


With regard to above aspects , treatment group and two control groups were compared , P < @ was considered statistically significant , then the result of S-N-K method showed that the treatment group was far better than the control group in the above four areas , however compared with traditional opening group laparoscopic resection group did not demonstrate any superiority .


Tracking the patients of treatment group proved no recurrence , and one case 's CT films before and after surgery were compared , further confirming the feasibility of microwave ablation .


To large hepatic hemangioma , laparoscopic microwave ablation in respect of intraoperative injury , postoperative recovery and costs is superior to other methods , and the treatment effect is certain , it 's feasible and worthy of promotion .


By use of a parallel and partly crossover randomised , controlled trial design we sought to elucidate the underlying mechanisms behind the advantageous effects of interval walking training ( IWT ) compared with continuous walking training ( CWT ) on glycaemic control in individuals with type @ diabetes .


We hypothesised that IWT , more than CWT , would improve insulin sensitivity including skeletal muscle insulin signalling , insulin secretion and disposition index ( DI ) .


By simple randomisation ( sequentially numbered , opaque sealed envelopes ) , eligible individuals ( diagnosed with type @ diabetes , no exogenous insulin treatment ) were allocated to three groups : a control group ( CON , n = @ ) , an IWT group ( n = @ ) and an energy expenditure-matched CWT group ( n = @ ) .


Training groups were prescribed free-living training , five sessions per week ( @ min/session ) .


A three-stage hyperglycaemic clamp , including glucose isotope tracers and skeletal muscle biopsies , was performed before and after a @ month intervention in a hospitalised setting .


No blinding was performed .


The improved glycaemic control , which was only seen in the IWT group , was consistent with IWT-induced increases in insulin sensitivity index ( @ @ % ; p < @ ) , peripheral glucose disposal ( @ @ % ; p < @ ) and DI ( @ @ % ; p < @ ) , with no changes in the CWT or CON group .


Moreover , only IWT improved insulin signalling in skeletal muscle via increased insulin-stimulated phosphorylation of AS@ ( @ @ % ; p < @ ) .


No changes were seen in insulin secretion during hyperglycaemia alone , hyperglycaemia + glucagon-like peptide @ infusion or arginine injection .


IWT maintains insulin secretion and improves insulin sensitivity and DI , in contrast to energy expenditure-matched CWT .


These results suggest that training with alternating intensity , and not just training volume and mean intensity , is a key determinant of changes in whole body glucose disposal in individuals with type @ diabetes .


Although bereavement and depression are both common in older primary care patients , the effect of bereavement on depression intervention outcomes is unknown .


We examined whether standard interventions for depression in primary care were as effective for bereaved as for non-bereaved depressed patients .


Randomized controlled trial .


Twenty community-based primary care practices in New York City , greater Philadelphia , and Pittsburgh .


Randomization to either intervention or usual care occurred by practice .


Patients aged @ years or older who met criteria for major depression or clinically significant minor depression ( N = @ ) .


Patients who did not complete the bereavement measure or who were missing @-month data were excluded ( final N = @ ) .


Study-trained depression care managers offered guideline-concordant recommendations to primary care physicians at intervention sites and assisted patients with treatment adherence .


Patients who did not wish to take antidepressants could receive interpersonal psychotherapy .


Bereavement was captured using the Louisville Older Persons Events Schedule .


Depression severity was assessed using the @-item Hamilton Depression Rating Scale ( HDRS ) .


Outcomes at @ months were remission ( HDRS@ ) and response ( HDRS reduction@ % from baseline ) .


Logistic regressions indicated that , for non-bereaved participants , response and remission were higher in intervention than usual care .


However , recently bereaved older adults were less likely to achieve response or remission at @ months if treated in the intervention condition .


Standard depression care management appears to be ineffective among recently bereaved older primary care patients .


Greater attention should be paid in primary care to emotional distress in the context of bereavement .


Maternal overweight , obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide .


The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before , during and after pregnancy in a primary health care setting for preventing gestational diabetes , later type @ diabetes and other metabolic consequences .


RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes ( a previous history of gestational diabetes or prepregnancy BMI @ kg/m@ ) .


Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics .


All participants visited a study nurse every three months before and during pregnancy , and at @ weeks , @ and @ months postpartum .


Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.Of the @ women -LSB- mean age @ years ( SD @ ) ; median parity @ ( range @-@ ) -RSB- considered to be eligible for the study @ were non-pregnant and @ pregnant -LSB- mean gestational age @ ( range @ to @ ) weeks -RSB- at the time of enrollment .


The proportion of nulliparous women was @ % ( n = @ ) .


Out of all participants , @ % of the non-pregnant and @ % of the pregnant women had previous gestational diabetes and @ % of the non-pregnant and @ % of the pregnant women were recruited because of a prepregnancy BMI @ kg/m@ .


Mean BMI at first visit was @ kg/m@ ( SD @ ) in the non-pregnant and @ kg/m@ ( SD @ ) in the pregnant group .


To our knowledge , this is the first randomized lifestyle intervention trial , which includes , besides the pregnancy period , both the prepregnancy and the postpartum period .


This study design also provides an opportunity to focus upon the health of the next generation .


The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age .


Human immunodeficiency virus ( HIV ) - infected individuals are at increased risk of cardiovascular disease ( CVD ) due in part to inflammation .


Statins decrease inflammation in the general population , but their effect during HIV infection is largely unknown .


This is an ongoing randomized , double-blinded , placebo-controlled trial to evaluate the effect of statin therapy on inflammatory markers during HIV infection .


Subjects received rosuvastatin @ mg daily or placebo for @ weeks .


Subjects were receiving stable ( > @ weeks ) antiretroviral therapy and had a low-density lipoprotein ( LDL ) cholesterol level of @ mg/dL and evidence of heightened immune activation or inflammation .


This was a prespecified interim analysis .


A total of @ subjects were enrolled ( @ % were male , @ % were black , and the median age was @ years ) .


By @ weeks , LDL cholesterol levels had decreased in the statin group , compared with an increase in the placebo group ( -@ % vs +@ % ; P < @ ) .


A @ % reduction in the lipoprotein-associated phospholipase A@ ( Lp-PLA@ ) level was seen in the statin group , compared with a @ % reduction in the placebo group ( P < @ ) .


In multivariable regression , receipt of statin treatment and having a nadir CD@ ( + ) T-cell count of @ cell/L were the only statistically significant predictors of a decrease in Lp-PLA@ level .


Markers of systemic inflammation did not change significantly between groups .


Twenty-four weeks of rosuvastatin therapy significantly decreased the level of Lp-PLA@ , a vascular-specific , inflammatory enzyme that predicts cardiovascular events in the general population .


Statins may hold promise as a means of attenuating CVD risk in HIV-infected individuals by decreasing Lp-PLA@ levels .


A non-blinded , cluster randomised controlled trial to test whether footwear reduces prevalence and intensity of hookworm infection in school-aged children on Pemba Island , Zanzibar .


Six schools were randomised to receive shoes and standard care ( deworming with albendazole and health education ) and six control schools to receive standard care only .


Children provided a stool sample to assess prevalence and intensity of infection with soil transmitted helminthiases ( Ascaris lumbricoides , Trichuris trichiura and hookworm ) .


Shoes were then distributed to pupils in the intervention schools ; deworming took place as part of the government 's mass drug administration programme and a further round of stool samples were collected six months later .


Nine hundred and fifteen children were traced at follow-up ( @ at baseline ) .


As many children wore shoes in the control arm as the intervention arm .


There was no difference in hookworm prevalence ( @ % for intervention schools , @ % for control schools , p = @ ) , and no difference in mean hookworm infection in eggs/gram of stool ( @ , @-@ in intervention schools , @ , @-@ in control schools , p = @ ) .


Shoe-wearing increased across all schools , from @ to @ % .


If a child wore shoes at the end of the study , the relative risk of hookworm infection was @ ( CI @-@ @ ) .


Due to contamination , the trial could not conclude that shoes were protective against hookworm infection but the intervention led to behavioural change , and observational data suggest that shoes are protective against hookworm .


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


The optimal anti-reflux procedure after Heller cardiomyotomy for oesophageal achalasia remains unclear .


The most commonly used procedure is the anterior partial fundoplication according to Dor , although during recent years the posterior counterpart ( Toupet ) has become popular .


Patients with newly diagnosed achalasia and referred for cardiomyotomy were randomised to receive either an anterior or partial posterior fundoplication following a classical cardiomyotomy .


The effect of surgery was assessed during the first postoperative year by Eckardt scores , EORTC QLQ-OES@ scores and HRQL questionnaires .


Timed barium oesophagogram ( TBO ) and ambulatory @-h pH monitoring were performed to determine oesophageal emptying and the degree of reflux control , respectively .


Forty-two patients were randomised into Dor ( n = @ ) and Toupet ( n = @ ) groups .


Eckardt scores improved dramatically with both procedures , but the EORTC QLQ-OES@ ( functional scales ) scores revealed significantly better relative improvements in the Toupet group compared to the Dor repair ( P = @ ) .


Corresponding advantages in favour of Toupet were observed postoperatively in the percentage of oesophageal emptying at TBO ( P = @ in height and P = @ in area ) , an effect not observed in the Dor group .


There were no other significant differences recorded between the study groups concerning HRQL evaluations and objective assessment of gastro-oesophageal acid reflux .


A partial posterior fundoplication after cardiomyotomy seems to achieve more improvement in oesophageal emptying and EORTC QLQ-OES@ functional scale scores than the anterior fundoplication .


Otherwise no differences between the two anti-reflux repairs were noted .


To evaluate a new perfusate solution to be used for ex vivo lung perfusion .


Randomized experimental study using lungs from rejected brain-dead donors harvested and submitted to @ hour of ex vivo lung perfusion ( EVLP ) using mainstream solution or the alternative .


From @ lungs blocs tested , we found no difference on weight after EVLP : Steen group ( SG ) = @,@ g ; Alternative Perfusion Solution ( APS ) = @g , p = @ .


Edema formation , assessed by Wet/dry weigh ratio , was statistically higher on the Alternative Perfusion Solution group ( APS = @ @ ; SG = @ @ ; p = @ ) .


No difference on PaO@ after EVLP ( SG = @ mmHg ; APS = @ mmHg , p = @ , nor on histological analyses : pulmonary injury score : SG = @ ; APS = @ , p = @ ; apoptotic cells count after perfusion : SG = @ @ cells/mm@ ; APS = @ @ cells/mm@ ; p = @ ) .


The ex vivo lung perfusion using the alternative perfusion solution showed no functional or histological differences , except for a higher edema formation , from the EVLP using Steen Solution ( r ) on lungs from rejected brain-dead donors .


To evaluate whether anti-inflammatory doses of cyclosporine activate Toxoplasma gondii in chronically infected cats or potentiate infection in cats exposed for the first time .


@ T gondii-negative cats .


Cats were assigned to @ of @ groups ( @ cats/group ) .


Group @ ( control ) cats were administered a placebo for @ days ; group @ cats were administered a placebo for @ days , followed by cyclosporine at @ mg/kg/d , PO , for @ days ; and group @ cats were administered cyclosporine at @ mg/kg/d , PO , for @ days .


Cats were orally inoculated with T gondii on day @ .


Results for fecal flotations , PCR assays , and histologic examinations and IgM and IgG titers were analyzed .


Cyclosporine concentrations were measured on selected days .


All cats were infected by T gondii and developed signs of self-limiting gastrointestinal tract infection .


Group @ had the highest incidence and severity of CNS and pulmonary histopathologic findings typical of toxoplasmosis .


One cat in group @ died of systemic toxoplasmosis ; that cat had a cyclosporine concentration of @,@ ng/mL .


Group @ cats infected with T gondii before cyclosporine administration did not have repeated oocyst shedding .