Zoledronic acid decreases the risk for skeletal-related events ( SREs ) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown .


This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer .


Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within @ months of study entry were randomly assigned in a blinded @:@ ratio to receive zoledronic acid ( @ mg intravenously every @ weeks ) or a placebo .


After their disease progressed to castration-resistant status , all patients received open-label treatment with zoledronic acid .


The primary end point was time to first SRE , defined as radiation to bone , clinical fracture , spinal cord compression , surgery to bone , or death as a result of prostate cancer .


Target accrual was @ patients .


Primary analysis was planned after @ SREs .


The study was discontinued prematurely ( @ patients ; @ SREs ) after the corporate supporter withdrew study drug supply .


Early zoledronic acid was not associated with increased time to first SRE .


The median time to first SRE was @ months in the zoledronic acid group ( @ % CI , @ to @ ) and @ months in the placebo group ( @ % CI , @ to @ ; hazard ratio , @ ; @ % CI , @ to @ ; one-sided stratified log-rank P = @ ) .


Overall survival was similar between the groups ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Rates of adverse events were similar between the groups .


In men with castration-sensitive prostate cancer and bone metastases , early treatment with zoledronic acid was not associated with lower risk for SREs .


About @ % of all pregnant women suffer low back pain and/or pelvic girdle pain ( LBPGP ) .


This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care .


This study will be a four-parallel-arm , multicentre , randomised , placebo-controlled trial .


A total of @ pregnant women ( @ to @weeks ' gestation ) , aged at least @years , with LBPGP , will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group ( VAAc ) , to the non-specific auricular acupuncture plus standard obstetric care group ( NSAAc ) , to the non-specific placebo auricular acupuncture plus standard obstetric care group ( PAAc ) , or the standard obstetric care group ( SOC ) .


The VAAc , NSAAc , and PAAc groups will receive treatment at three auricular acupuncture points ( specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups ) , once a week for @weeks ; the SOC group will receive only standard obstetric care during the same period .


The primary outcome will be the reduction in pain intensity , according to the visual analogue scale ( iVAS ) , at @weeks after the start of treatment .


The secondary outcomes will be functional status with respect to LBPGP ( according to the Roland-Morris disability questionnaire ) , health-related quality of life ( SF@ ) at @weeks after the start of treatment , and iVAS at @ and @weeks postpartum .


This trial will implement a high-quality methodology and may provide evidence for the efficacy , safety , and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP .


To explore safe , effective , simple and easy non-drug treatments for grade @ essential hypertension .


According to TCM syndrome differentiation , @ cases of grade @ essential hypertension were classified into @ types : liver-fire hyperactivity syndrome , yin-deficiency and yang-hyperactivity syndrome , excessive phlegm-dampness syndrome , yin-yang deficiency syndrome , and then the patients were randomly divided into a photoelectric combined with musical treatment group ( group A ) , an acupuncture group ( group B ) and a placebo group ( group C ) .


The acupoints were selected according to TCM syndrome differentiation in group A and group B , and multi-mode audio frequency pulse photoelectric therapeutic apparatus and acupuncture were used in the two groups respectively , once daily .


Taichong ( LR @ ) and Quchi ( LI @ ) were selected in liver-fire hyperactivity syndrome , Taixi ( KI @ ) and Sanyinjiao ( SP @ ) were selected yi yin-deficiency and yang-hyperactivity syndrome , Zusanli ( ST @ ) and Fenglong ( ST @ ) were selected in excessive phlegm-dampness syndrome , while Taixi ( KI @ ) and Guanyuan ( CV @ ) were selected yi yirryang deficiency syndrome .


The group C was treated with oral administration of starch tablet ( @ mg ) , one tablet each time , three times everyday .


Ten days were considered as one course , totally three courses were required in the three groups .


The blood pressure and scores of TCM syndromes before and after treatment were compared among the three groups .


The blood pressure decreased significantly after treatment in group A and group B ( all P < @ ) , and the decrease in systolic blood pressure was more significant in group A ( P < @ ) .


The total effective rate was @ / ( @/@ ) in group A , which was superior to @ ( @/@ , P < @ ) in group B and @ % ( @/@ , P < @ ) in group C.


The scores of TCM syndromes were both improved in group A and group B , but without significant difference between the two groups ( P > @ ) .


The clinical effect of multi-mode audio frequency pulse photoelectric therapeutic apparatus for treatment of grade @ essential hypertension is reliable .


Meanwhile , it has the advantages of a non-invasive and simple operation .


To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia .


A randomized controlled trial was conducted in the Netherlands between April @ , @ , and August @ , @ .


A total of @ postpartum women with anemia ( hemoglobin < @ g/dL ) were randomly allocated to receive @ mg/day ferrous fumarate plus @mg/day folic acid ( FFFA group ) or @/day ferrous fumarate alone ( FF group ) for @ weeks .


Primary outcome measures were hemoglobin and health status .


Secondary outcome measures were fatigue , compliance , and adverse reactions .


No between-group differences were observed in hemoglobin and health status after treatment , and no differences were found in fatigue scores .


Approximately @ % of all women reported having at least one symptom resulting from ferrous fumarate use .


Constipation caused by ferrous fumarate was significantly associated with non-compliance ( P = @ ) .


The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia , as it has no effect on hematologic or health status parameters .


Data show that many research subjects have difficulty understanding study information using traditional paper consent documents .


This study , therefore , was designed to evaluate the effect of an interactive multimedia program on improving parents ' and children 's understanding of clinical trial concepts and participation .


Parents ( n = @ ) and children ( n = @ ) were each randomised to receive information regarding clinical trials using either a traditional paper format ( TF ) or an interactive iPad program ( IP ) with inline exercises .


Participants ' understanding of the information was assessed using semistructured interviews prior to ( pretest ) and after ( post-test ) receiving the information .


Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process .


Regardless of the mode of information delivery , all participants demonstrated improved pretest to post-test understanding .


While there were no statistical differences in parents ' post-test understanding between the TF and IP groups , children in the IP group had significantly greater post-test understanding compared with children in the TF group ( @ ( @ ) vs @ ( @ ) ( @ , @ , @ ) @-@ scale where @ = complete understanding ) .


Furthermore , the IP was found to be significantly ` easier to follow ' and ` more effective ' in presenting information compared with the TF .


Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children .


Importantly , the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery , particularly among children , supports this approach as a novel and effective vehicle for enhancing the informed consent process .


Many cancer patients report unmet rehabilitation needs .


Rehabilitation may include activities of daily living ( ADL ) tasks , but little is known about how cancer patients perform these tasks and how they prioritize their daily activities .


Hence , this study aims to identify and characterize ADL task performance problems among a group of adult disabled hospitalized cancer patients using interview and questionnaire data .


Cross-sectional study on prevalence of ADL task performance problems experienced by disabled hospitalized cancer patients using the Activities of Daily Living Questionnaire ( ADL-Q ) ( n = @ ) and the Canadian Occupational Performance Measure ( COPM ) ( n = @ ) .


All @ patients reported problems with ADL task performance .


Based on the ADL-Q patients reported more problems within instrumental ( I - ) ADL than personal ( P - ) ADL .


In both I-ADL and P-ADL the results differed between women and men .


There was significant overlap between problems identified using the COPM and the ADL-Q instruments .


RESULTS from the COPM showed that @ % of problems were related to self-care , @ % to leisure , and @ % to productivity .


Using both instruments identified more ADL problems than when using only one of the instruments .


Adult hospitalized disabled cancer patients experience a high degree and variation in difficulties performing ADL , illustrating the need for a comprehensively planned assessment of problems and needs .


Long-term follow-up study is required for verifying whether the clinical outcomes of kyphoplasty and vertebroplasty are altered .


The authors ' findings showed only subtle differences between these operations within a @-year period .


However , they still suggest the use of vertebroplasty over kyphoplasty in view of the treatment costs .


In their previous study , the authors performed a short-term prospective comparison between vertebroplasty and kyphoplasty .


Vertebroplasty was recommended instead of kyphoplasty for the treatment of vertebral compression fractures ( VCFs ) because of the subtle differences between this procedure and kyphoplasty and the treatment costs .


To determine whether these clinical outcomes persist in the long term , they continued to observe the patients from their short-term study over a longer-term period .


METHODS : One hundred cases of VCF were assigned randomly to either the kyphoplasty or the vertebroplasty group .


In cement augmentation , the authors used polymethylmethacrylate as bone filler .


Pain was assessed by using a visual analog scale ( VAS ) .


For each patient , vertebral body height and wedge angle were measured from reconstructed CT images .


The duration of the follow-up period was @ years .


Vertebral body height , kyphotic wedge angle , and VAS score were not evidently altered .


Eight patients in the kyphoplasty group had an adjacent fracture after the procedure , whereas @ patients in the vertebroplasty group had an adjacent fracture after the procedure .


These adjacent fractures occurred within @ year of surgery in both treatment groups except in @ kyphoplasty-treated patient in whom the adjacent fracture was noted @ months after treatment .


Three patients in the vertebroplasty group had a nonadjacent fracture , and @ patients in the kyphoplasty group had a nonadjacent fracture .


The link between angular correction and the occurrence of adjacent fracture was statistically significant in the vertebroplasty group .


Excessive angular correction is a critical concern in the risk of adjacent fracture after vertebroplasty .


Given the subtle differences between vertebroplasty and kyphoplasty observed over the course of @ years , vertebroplasty remains the preferred option in view of the costs .


To determine the rate of cervical intraepithelial neoplasia grade @ ( CIN@ + ) in women with low grade cervical cytology and a normal colposcopy examination over @ years of follow-up .


Cohort study within a randomised controlled trial .


NHS Cervical Screening Programmes in Grampian , Tayside and Nottingham .


Eight hundred and eighty-four women aged @-@ years with borderline nuclear abnormalities ( BNA ) or mild dyskaryosis with a normal and adequate colposcopy examination .


Samples at baseline were tested for @ high-risk ( Hr ) types using GP@ +@ + methodology and for HPV @ and @ using type-specific primers .


Women were followed up post-colposcopy by cervical cytology at @-month intervals in primary care .


After @ years , women were invited for an exit colposcopy examination and underwent LLETZ if any colposcopic abnormality was identified .


Absolute and relative risks of CIN@ + during follow-up and/or at exit colposcopy .


The median age was @ years .


The absolute risk of developing CIN@ + within @ years was @ per @ woman years and for CIN@ + , @ per @ woman years .


One microinvasive cancer was identified .


The relative risk ( RR ) was highest for women with initial mild dyskaryosis who were HrHPV-positive ( RR @ , @ % confidence interval @-@ @ ) compared with women with BNA who were HrHPV-negative .


For women with low grade cervical cytology , the risk of a high grade CIN within @ years of a normal colposcopy examination is low .


Women can be reassured that , even with a positive HPV test , the risk of developing CIN@ or worse is sufficiently low to return to the routine @-year recall .


Constipation is a very common symptom in the general population .


One way of non-pharmacological treatment of constipation is through the addition of probiotics to food .


The aim of this study was to evaluate de effect of the consumption of a fresh cheese , enriched with Bifidobacterium lactis Bi-@ on the symptoms of constipated women .


A randomized controlled trial , carried out in the Basic Health Units of Guapor 's City - RS/Brazil , between January and May @ , with @ constipated women .


The patients were randomized into two groups whom received , for @ days , @ g of fresh cheese enriched with Bifidobacterium lactis Bi-@ ( n = @ ) or regular fresh cheese ( n = @ ) .


Constipation symptoms were evaluated according to ROMA III Consensus , before and after the nutritional intervention .


Also , data of clinical and anthropometric characteristics of the individuals were collected .


Accepted level of significance @ % ( P@ ,@ ) .


The medium age of the studied population was @,@,@ years in the intervention group and @,@,@ years in the control group .


After @ days we observed that the ingestion of fresh cheese enriched with Bifidobacterium lactis Bi-@ promoted benefic effects on the symptoms of strength to evacuate .


The consumption of @g/day of a fresh cheese enriched with Bifidobacterium lactis Bi-@ has beneficial effects on constipation symptoms .


There is a need to improve participation in colorectal cancer screening .


Our objective was to assess the impact of a signature from the patient 's general practitioner on a letter inviting patients to participate in a colorectal cancer screening .


We conducted a cluster randomized controlled trial with @ general practitioners established in Paris for more than @ years , randomized to intervention or usual-care arms .


There were @ patients included , ages @-@ years , from general practitioner patient files , and eligible for an invitation letter or a reminder letter to participate in the national population-based screening program .


In the intervention arm , patients received a standard letter signed by their general practitioner inviting them to visit the general practitioner 's office for a fecal occult blood test if they were eligible .


Control patients received the standard invitation letter or the standard reminder .


All letters were sent by the district screening organization .


The main outcome was the proportion of patients who took the fecal occult blood test within @ months after the invitation .


Among patients eligible for the study , @ ( @ % ) took a fecal occult blood test after being invited ; @ ( @ % ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) in the intervention group and @ ( @ % ; @ % CI , @-@ @ ) in the control group , with no statistical difference between the @ groups ( odds ratio @ ; @ % CI , @-@ @ ; P = @ ) .


The addition of a general practitioner 's signature to a standard letter inviting patients to take a fecal occult blood test had no impact on the frequency of patients taking the fecal occult blood test in the Paris program of colorectal cancer screening .


To observe the therapeutic effect of acupuncture and moxibustion interventions in the treatment of chronic fatigue syndrome ( CFS ) .


A total of @ CFS patients were randomized into acupuncture group ( @ cases ) , warm-needling group ( @ cases ) and non-acupoint group ( @ cases ) .


Manual acupuncture ( MA ) stimulation was applied to Baihui ( GV @ ) , Danzhong ( CV @ ) , Qihai ( CV @ ) , Guanyuan ( CV @ ) , bilateral Zusanli ( ST @ ) , Hegu ( LI @ ) , Taichong ( LR @ ) and Sanyinjiao ( SP @ ) for patients in the acupuncture group .


For patients in the warm-needling group , moxa-heated needle was applied to Baihui ( GV @ ) , Qihai ( CV @ ) , Guanyuan ( CV @ ) and bilateral Zusanli ( ST @ ) .


Non-acupoints were located about @-@ cm beside the Baihui ( GV @ ) , Danzhong ( CV @ ) , Qihai ( CV @ ) , Guanyuan ( CV @ ) , Zusanli ( ST @ ) , Taichong ( LR @ ) , Sanyinjiao ( SP @ ) and Hegu ( LI @ ) .


The treatment was given once daily for @ days .


The Chalder Fatigue Scale ( @-item fatigue scale ) was adopted to evaluate the changes of CFS before and after the treatment .


In comparison with pre-treatment , the scores of Chalder Fatigue Scale including physical and mental fatigue and total score were significantly decreased in both acupuncture and warm-needling groups ( P < @ , P < @ ) , but not in the non-acupoint group ( P > @ ) except physical score ( P < @ ) .


The physical , mental and total scores of the acupuncture and warm-needling groups were significantly lower than those of the non-acupoint group ( P < @ , P < @ ) , while the physical and total scores of the warm-needling group were markedly lower than those of the acupuncture group ( P < @ ) .


After the treatment , the CFS patients ' satisfactory rates of the acupuncture , warm-needling and non-acupoint groups were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) , respectively .


Both MA and warm-needling interventions have a good therapeutic effect in the treatment of CFS patients , while the latter is obviously better .


To test the effectiveness of a programme aimed at reducing the risky use of alcohol and alcohol-related HIV risk and increase help-seeking behaviour among a sample of municipal employees in the Western Cape Province , South Africa .


A clustered randomised controlled trial was conducted in @-@ among @ employees .


The eight hour intervention , Team Awareness ( TA ) , addressing behavioural risk among employees was administered to @ employees in the intervention arm and the @ employees in the control arm who received a one-hour wellness talk .


The results show that TA had the greatest impact on risky drinking practices and hangover effects .


There was a significant group time interaction ( F ( @ , @ ) = @ , p < @ ) with participants in the intervention condition reducing number of days on which they engaged in binge drinking .


There was also a significant time effect with participants in the intervention condition reducing the likelihood of going to work with a hangover ( F ( @,@ ) = @ , p = @ ) .


No reduction in HIV-related risk behaviours were found .


This intervention study was able to demonstrate a modest but significant reduction in risky drinking practices and hangover effects .


This provides encouraging evidence for the effectiveness of interventions that address risky use of alcohol among employed persons , further providing a launch pad for strengthening and replicating future RCT studies on workplace prevention , especially in developing country settings .


Insufficient sleep is associated with increased cardiometabolic risk .


Alterations in hypothalamic-pituitary-adrenal axis may underlie this link .


Our objective was to examine the impact of restricted sleep on daytime profiles of ACTH and cortisol concentrations .


Thirteen subjects participated in @ laboratory sessions ( @ nights of @ hours in bed versus @ nights of @ hours in bed ) in a randomized crossover design .


Sleep was polygraphically recorded .


After the second night of each session , blood was sampled at @-minute intervals from @:@ am to midnight to measure ACTH and total cortisol .


Saliva was collected every @ minutes from @:@ pm to midnight to measure free cortisol .


Perceived stress , hunger , and appetite were assessed at hourly intervals by validated scales .


Sleep restriction was associated with a @ % increase in overall ACTH levels ( P < @ ) that was correlated with the individual amount of sleep loss ( rSp = @ , P < @ ) .


Overall total cortisol levels were also elevated ( +@ % ; P = @ ) .


Pulse frequency was unchanged for both ACTH and cortisol .


Morning levels of ACTH were higher after sleep restriction ( P < @ ) without concomitant elevation of cortisol .


In contrast , evening ACTH levels were unchanged while total and free cortisol increased by , respectively , @ % ( P < @ ) and @ % ( P < @ ) .


Thus , the amplitude of the circadian cortisol decline was dampened by sleep restriction ( -@ % ; P < @ ) .


Sleep restriction was not associated with higher perceived stress but resulted in an increase in appetite that was correlated with the increase in total cortisol .


The impact of sleep loss on hypothalamic-pituitary-adrenal activity is dependent on time of day .


Insufficient sleep dampens the circadian rhythm of cortisol , a major internal synchronizer of central and peripheral clocks .


Inflammation and coagulation biomarkers interleukin ( IL ) -@ and D-dimer are predictive of all-cause mortality in chronic HIV-@ infection ; however , their predictive value in individuals with recent infection has not been described .


SPARTAC was a randomized controlled trial comparing three strategies of intervention in primary HIV-@ infection -LSB- no therapy , @-week or @-week antiretroviral therapy ( ART ) -RSB- .


Plasma IL-@ and D-dimer were measured in @ participants from sites in Australia , Brazil , UK and Italy .


We evaluated age , sex/HIV risk group , time since HIV-@ seroconversion , baseline HIV-RNA , CD@ cell count and BMI as possible predictors of IL-@ and D-dimer levels at seroconversion using multivariable linear regression .


For participants remaining ART-naive , we evaluated whether baseline IL-@ and D-dimer levels independently predicted time to reaching CD@ cell count less than @ cells/l or initiating ART using multivariable Cox proportional hazards models .


Median ( interquartile range , IQR ) baseline IL-@ and D-dimer levels were @ ( @-@ @ ) pg/ml and @ ( @-@ @ ) g/l , respectively .


Higher levels were associated with older age ( P = @ and @ , respectively ) .


Higher D-dimer levels were associated with higher HIV-RNA ( P < @ ) .


For the @ participants not initiating ART ( median follow-up @ weeks ) , of whom @ reached the primary endpoint , higher baseline IL-@ , but not D-dimer , was independently associated with a shorter time to primary endpoint -LSB- hazard ratio = @ per additional pg/ml , @ % confidence interval ( CI ) @-@ @ ; P = @ -RSB- .


Other baseline predictors were older age ( P = @ ) , higher RNA ( P = @ ) and lower CD@ cell count ( P < @ ) .


IL-@ levels at time of HIV-@ seroconversion independently predict HIV-@ disease progression in patients with primary HIV-@ infection .


The incidence of propofol injection pain is high in children , but no methods have been found to suppress it completely .


This study intends to evaluate the efficacy of dexmedetomidine-midazolam in preventing propofol injection pain in children .


One-hundred ASA I patients , aged @-@ years , weighing @-@ kg , undergoing elective surgery were randomized into two groups of @ each , using computer-generated random numbers .


Normal saline @ ml/kg in Group C or dexmedetomidine @ g/kg in Group D was infused IV over @ min .


Then midazolam @ mg/kg was administered immediately ; @ min after aforementioned treatments in each group , all patients received propofol @ mg/kg ( propofol was mixed with lidocaine @ mg/ml in Group C ) at an average rate of @ ml per @ s. Another anesthesiologist , blind to the pretreatment , recorded the occurrence of injection pain using a four-graded pain scale : @ = no pain ( no reaction to injection ) , @ = slight pain ( minor verbal/facial response or motor reaction to injection ) , @ = moderate pain ( clear verbal/facial response or motor reaction to injection ) and @ = severe pain ( the patient both complained of pain and withdrew the arm ) .


Forty ( @ % ) patients in Group C ( control ) had injection pain ; however , none of patients in Group D had any injection pain .


The total incidence of profol-induced pain in Group C was significantly higher ( P < @ ) .


There were no instances of bradycardia or low blood pressure with either treatment in this study .


Pretreatment with dexmedetomidine @ g/kg , then midazolam @ mg/kg could suppress propofol injection pain in children .


To compare the antioxidant and inflammatory cytokine activities in tears of patients with dry eye syndrome treated with preservative-free versus preserved eye drops .


A total of @ patients with moderate to severe dry eye syndrome were randomly divided into two groups .


Fifty patients ( group @ ) were treated four times with preservative-free @ % sodium hyaluronate and @ % fluorometholone eye drops in the first month and with preservative-free @ % sodium hyaluronate and @ % cyclosporine eye drops in the second and third months .


Another @ patients ( group @ ) were treated with preserved eye drops on the same schedule .


Ocular Surface Disease Index , corneal fluorescein staining , Schirmer I test , tear film breakup time , impression cytology , and antioxidant and inflammatory cytokine activities in tears were evaluated .


Treatment with preservative-free eye drops led to significant improvements in symptoms , tear film breakup time , Schirmer I score , and impression cytologic findings compared to treatment with preserved eye drops ( P < @ ) in patients with dry eye syndrome .


There was a statistically significant decrease in the IL-@ , IL-@ , IL-@ , and TNF - concentrations and a statistically significant increase in the catalase , peroxiredoxin @ , superoxide dismutase @ ( SOD @ ) , and thioredoxin mean fluorescence intensity ( MFI ) of tears in the preservative-free group at @ , @ , and @ months compared to initial values , respectively ( P < @ ) .


Treatment with preservative-free eye drops is effective against the dry eye syndrome .


Preservative-free eye drops seem to be more effective than preserved eye drops in decreasing ocular inflammation and in increasing antioxidant contents in tears of patients with dry eye syndrome .


The purpose of our study was to evaluate and compare two methods of service delivery ( web-based and telehealth-based ) for chronic insomnia with regard to patient preference , clinical effectiveness , and patient satisfaction .


Our study was a randomized controlled trial with manualized telehealth - and web-based delivery conditions ( nonblinded ) .


The sample comprised @ adults with chronic insomnia .


Participants received web-based delivery from their homes or telehealth-based delivery from a nearby clinic .


Both interventions consisted of identical psychoeducation , sleep hygiene and stimulus control instruction , sleep restriction treatment , relaxation training , cognitive therapy , mindfulness meditation , and medication-tapering assistance .


Using a linear mixed model analysis , results showed that both delivery methods produced equivalent changes in insomnia severity , with large effect sizes .


Attendance patterns favored telehealth , whereas homework adherence and preference data favored web-based delivery .


Web - and telehealth-based delivery are both helpful in treating chronic insomnia in rural-dwelling adults .


Metabolic syndrome ( MetS ) comprises a spectrum of clinical phenotypes in which dyslipidemia , dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease .


This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS .


In a double blind placebo controlled randomized trial , @ persons with MetS , as defined by the ATPIII criteria , received the study product or placebo for @ weeks .


The study product contained @ mg of monacolins and @,@ mg of hydroxytyrosol per capsule , and is commercialized as Cholesfytol plus .


The primary outcome measure was the difference in LDL reduction between intervention and control groups .


Furthermore , differences in changes of CH , HDL , ApoA@ , ApoB , HbA@c and oxLDL were measured , as well as side-effects , CK elevation , changes in clinical parameters and in cardiovascular risk .


In the intervention group , LDL cholesterol was lowered by @ % whereas it increased by @ % in the control group ( p < @ ) .


Other effects observed were a change in total cholesterol ( -@ % in the intervention group vs +@ % in the control group , p < @ ) , apolipoprotein B ( -@ % vs +@ % , p < @ ) , and TG ( -@ % vs + @ % , p = @ ) .


Oxidized LDL decreased by @ % vs an increase of @ % in the control group ( p < @ ) .


Systolic and diastolic arterial blood pressure decreased significantly by @ mmHg ( vs @ % in the control group , p = @ ) and @ mmHg ( vs @ % in the control group , p = @ ) respectively .


One person in the intervention group , who suffered from Segawa 's syndrome , dropped out because of severe muscle ache .


The combination of active products in this study may be an alternative approach to statins in people who do not need , or can not or do not want to be treated with chemical statins .


Side effects , effects on oxidative stress and on glucose metabolism need to be examined more thoroughly .


Neurobehavioral functioning is widely recognized as being an important consideration in lung transplant candidates , but little is known about whether these factors are related to clinical outcomes .


The present study examined the relationship of neurobehavioral functioning , including measures of executive function and memory , depression , and anxiety , to long-term survival among lung transplant recipients .


The sample was drawn from @ patients who underwent transplantation at Duke University and Washington University who participated in a dual-site clinical trial investigating medical and psychosocial outcomes in transplant candidates with end-stage lung disease .


All patients completed the Beck Depression Inventory-II ( BDI-II ) and Spielberger State-Trait Anxiety Inventory at baseline and again after @ weeks , while a subset of @ patients from Duke University also completed neurocognitive testing .


Patients were followed for survival up to @ years after completing baseline assessments .


One hundred eleven patients died over a mean follow-up of @ years ( SD = @ ) .


Baseline depression , anxiety , and neurocognitive function were examined as predictors of posttransplant survival , controlling for age , @-min walk distance , FEV , and native disease ; education and cardiovascular risk factors were also included in the model for neurocognition .


Lower executive function ( hazard ratio -LSB- HR -RSB- = @ , P = @ ) and memory performance ( HR = @ , P = @ ) were independently associated with greater mortality following lung transplant .


Although pretransplant depression and anxiety were not predictive of mortality , patients who scored > @ on the BDI-II at baseline and after @ months pretransplant had greater mortality ( HR = @ -LSB- @ % CI , @ , @ -RSB- , P = @ ) .


Neurobehavioral functioning , including persistently elevated depressive symptoms and lower neurocognitive performance , was associated with reduced survival after lung transplantation .


To compare measures of dry mouth following extended use of an alcohol-based mouthrinse ( LISTERINE Antiseptic -LSB- LA -RSB- ) and a non-alcohol-based mouthrinse ( Crest Pro-Health Rinse -LSB- CPH -RSB- ) on healthy adults with `` normal '' salivary flow .


This single-site , randomized , observer-blinded , parallel study compared unstimulated whole salivary flow and perceived dryness following daily use at weeks @ and @ versus baseline .


Noninferiority , between-treatment flow comparisons ( @ mL/min margin ) , and between-treatment comparisons of the mean Bluestone Mouthfeel Questionnaire ( BMQ ) visual analog scale scores were made using analysis of covariance .


Measures of dry mouth were comparable between mouthrinses , as demonstrated by both noninferiority of LA versus CPH flow ( P < @ ) and no significant differences between groups in the BMQ measures at @ or @weeks .


Extended use of an alcohol-based mouthrinse is no more likely to cause reduction in salivary flow or perceived dryness in individuals with normal salivary flow compared with a non-alcohol-based mouthrinse ( CPH ) .


To investigate the relationship between optic nerve sheath diameter ( ONSD ) and retrobulbar blood flow velocities , as measured by color Doppler imaging ( CDI ) in glaucoma patients .


We performed a prospective , randomized , observer-masked study involving a total of @ subjects .


Once enrolled , they were divided by three groups : healthy controls ( n = @ ) , normal-tension glaucoma patients ( NTG , n = @ ) , and primary , open-angle glaucoma patients ( POAG , n = @ ) .


All subjects underwent a general ophthalmological examination , an ultrasound-based assessment of the ONSD , and a hemodynamic study of the retrobulbar vascularization using CDI .


Non-parametric tests , chi-square contingency tables , and the Deming correlations were used to explore differences and correlations between variables in the diagnostic groups .


ONSD was not different between experimental groups ( p = @ ) .


ONSD correlated positively with the pulsatility index of the ophthalmic artery in healthy individuals ( p = @ ) , but not in glaucoma patients ( NTG : p = @ ; POAG : p = @ ) .


In NTG patients , higher ONSD values were associated with lower end-diastolic and mean flow velocities in the short ciliary arteries ( p = @ in both correlations ) .


No such correlation was found in healthy nor POAG groups ( p range between @ to @ ) .


ONSD was not associated with any CDI-related variable of the central retinal artery in any cohort .


Venous outflow velocities were not associated with ONSD in any of the three groups .


ONSD is negatively correlated with retrobulbar blood flow velocities in glaucoma patients , but not in healthy controls .


The objective of this study was to compare the efficacy and safety of dexamethasone and methylprednisolone for pulse therapy of rheumatoid arthritis flare-up .


This randomized double-blind controlled study was performed in the Emam Reza Educational Hospital of Tabriz University of Medical Sciences , Tabriz , Iran .


Thirty rheumatoid arthritis patients who had severely active disease were recruited to the dexamethasone and methylprednisolone pulse groups .


Disease activity of all the patients was measured by the Disease Activity Score in @ joints ( DAS@ ) at baseline , and days @ and @ .


The differences in the DAS@ at days @ and @ , and the number of patients whose DAS@ obtained less than @ and @ in the dexamethasone and methylprednisolone groups were non-significant .


There was not any significant difference between the adverse effects of the treatments in the two groups .


The results of the study suggest that dexamethasone pulse therapy is a safe and effective treatment for severe rheumatoid arthritis flare-up .


Both supervised exercise ( SE ) and stenting ( ST ) improve functional status , symptoms , and quality of life compared with optimal medical care ( OMC ) in patients with claudication .


The relative cost-effectiveness of these strategies is not well defined .


The Claudication : Exercise Versus Endoluminal Revascularization ( CLEVER ) study randomized patients with claudication due to aortoiliac stenosis to a @-month SE program , to ST , or to OMC .


Participants who completed @-month follow-up ( n = @ ) were included in a health economic analysis through @ months .


Costs were assessed using resource-based methods and hospital billing data .


Quality-adjusted life-years were estimated using the EQ-@D .


Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life .


Through @ months , mean healthcare costs were $ @ , $ @ , and $ @ @ per patient for OMC , SE , and ST , respectively .


Measured quality-adjusted life-years through @ months were @ , @ , and @ .


In our base case analysis , which assumed that observed differences in quality of life would dissipate after @ years , the incremental cost-effectiveness ratios were $ @ @ per quality-adjusted life-year gained for SE versus OMC , $ @ @ for ST versus OMC , and $ @ @ for ST versus SE .


If the treatment effect of ST was assumed to be more durable than that of SE , the incremental cost-effectiveness ratio for ST versus SE became more favorable .


Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease .


ST is more expensive than SE , with uncertain incremental benefit .


Vitiligo can be associated with high levels of distress , yet there are currently no self-help interventions available .


To describe the initial development of a psychosocial self-help intervention designed to reduce social anxiety associated with vitiligo .


Also to examine whether including a planning exercise , aimed at increasing use of the intervention ( termed implementation intentions ) , has the potential to achieve a clinically significant reduction in distress .


Participants ( n = @ ) were randomized to one of three groups : cognitive behavioural self-help ( CBSH ) , CBSH augmented with implementation intentions ( CBSH + ) , or no intervention .


Participants were assessed at baseline and after @weeks on measures of social anxiety , anxiety and depression , and appearance-related concern .


The two intervention groups also completed a questionnaire evaluating their use of , and satisfaction with , the intervention .


High levels of social anxiety and concern over appearance were reported .


Twenty-four per cent of participants in the CBSH + group experienced clinically significant change on the measure of social anxiety compared with @ % in the CBSH group and @ % in the control group .


In addition , @ % of the control group deteriorated during the study period .


There were no significant differences between the conditions on the other outcome measures .


Participants reported that the self-help leaflets were helpful .


The findings demonstrate that augmented CBSH provides a relatively simple and accessible intervention that can result in a clinically significant reduction in social anxiety .


The augmented intervention has potential and might be further developed and evaluated in subsequent trials .


In the final analysis of the phase @ COU-AA-@ study , abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .


Here , we present the final analysis of an early-access protocol trial that was initiated after completion of COU-AA-@ to enable worldwide preapproval access to abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .


We did a multicentre , open-label , early-access protocol trial in @ countries .


We enrolled patients who had metastatic castration-resistant prostate cancer progressing after taxane chemotherapy .


Participants received oral doses of abiraterone acetate ( @ mg daily ) and prednisone ( @ mg twice a day ) in @-day cycles until disease progression , development of sustained side-effects , or abiraterone acetate becoming available in the respective country .


The primary outcome was the number of adverse events arising during study treatment and within @ days of discontinuation .


Efficacy measures ( time to prostate-specific antigen -LSB- PSA -RSB- progression and time to clinical progression ) were gathered to guide treatment decisions .


We included in our analysis all patients who received at least one dose of abiraterone acetate .


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


Between Nov @ , @ , and Sept @ , @ , @ patients were enrolled into the early-access protocol trial .


Median follow-up was @ months ( IQR @-@ ) .


@ ( @ % ) patients had a grade @ or @ treatment-related adverse event , and grade @ or @ serious adverse events were recorded in @ ( @ % ) people .


The most common grade @ and @ adverse events were hepatotoxicity ( @ -LSB- @ % -RSB- ) , hypertension ( @ -LSB- @ % -RSB- ) , cardiac disorders ( @ -LSB- @ % -RSB- ) , osteoporosis ( @ -LSB- @ % -RSB- ) , hypokalaemia ( @ -LSB- @ % -RSB- ) , and fluid retention or oedema ( @ -LSB- @ % -RSB- ) .


@ ( @ % ) patients discontinued the study because of adverse events ( @ -LSB- @ % -RSB- were drug-related ) , as assessed by the investigator , and @ ( @ % ) people died .


The funder assessed causes of death , which were due to disease progression ( @ -LSB- @ % -RSB- ) , an unrelated adverse experience ( @ -LSB- @ % -RSB- ) , and unknown reasons ( @ -LSB- @ % -RSB- ) .


Of the @ deaths not attributable to disease progression , @ ( < @ % ) were caused by a drug-related adverse event , as assessed by the investigator .


Median time to PSA progression was @ months ( @ % CI @-@ ) and median time to clinical progression was @ months ( @-@ ) .


No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy .


Future work is needed to ascertain the most effective regimen of abiraterone acetate to optimise patients ' outcomes .


In the last years there has been a progressive reduction of the average duration of sleep and an increase in the incidence of sleep disturbances .


At the same time , an increase of the incidence of the metabolic syndrome has been described , partly attributable to the progressive worsening of dietary habits and the increase in sedentary lifestyle .


Recent studies suggest that adequate sleep is essential to maintain good glucose metabolism and sleep disturbances may contribute to the manifestation of the metabolic syndrome .


Benzodiazepines ( BZ ) , such as brotizolam , and imidazopyridines , such as zolpidem , are frequently used as hypnotics but their potential impact on glucose metabolism has never been evaluated so far .


In @ healthy volunteers -LSB- age ( mean SEM ) @ @ years ; body mass index ( BMI ) @ @ kg/m -RSB- we studied glucose and insulin responses to oral glucose tolerance test ( OGTT , @ g ) before and after @ days treatment with brotizolam @ mg/day or zolpidem @ mg/day .


Brotizolam increased glucose delta area under curve response to the OGTT by @ % ( p < @ ) and zolpidem by @ % ( p < @ ) without significant variations of insulin levels , suggesting an impact on insulin sensitivity and/or insulin secretion .


This study suggests that BZ and imidazopyridines have a rapid glucometabolic effect that is detectable as early as after @ days treatment .


To compare the therapeutic and side effects of using Californium@ ( @Cf ) neutron brachytherapy with neoadjuvant intra-arterial embolism chemotherapy in combination with surgery for treating Stage Ib@-IIb cervical cancers ( CCs ) .


Thirty-two Stage Ib@-IIb CC patients were enrolled and randomly divided into two groups from January @ to April @ in the present Hospital .


Prior to surgery within four weeks , a total of @ cases were treated with @Cf neutron brachytherapy ( @-@ cGy doses at point A ) once a week ( Group A ) , and @ cases were treated by neoadjuvant intra-arterial embolism chemotherapy using a combination of bleomycin , carboplatin , and cyclophosphamide twice ( Group B ) .


The clinical symptoms and signs , side effects , and relapse condition follow up until July @ were compared between the two groups for the perioperation .


Reductions in tumor mass and CR+PR were not significantly different between the groups before the surgery ( p > @ ) .


Abdominal pain and pelvic adhesions were significantly more severe in Group B ( p < @ ) .


There were no significant differences in surgical time , blood loss or the other side effects between Groups A and B ( p > @ ) .


The percentage of pelvic tumor recurrences in Group A was lower than that of the patients in Group B ( @ % vs @ % ) although with no significant difference at present .


No distant metastasis has been found in both two groups .


Except for less abdominal pain and pelvic adhesions , @Cf neutron brachytherapy has perioperative effects similar to those of neoadjuvant intra-arterial embolism chemotherapy .


New-onset postoperative atrial fibrillation ( POAF ) after coronary artery bypass graft surgery ( CABG ) is associated with worse in-hospital morbidity and mortality , extended hospital stays , and higher costs .


Beyond the initial hospital discharge , the cost and outcomes of POAF have not been well studied .


For CABG patients with and without new-onset POAF , a retrospective propensity-matched , multivariable regression analysis was performed to compare @-year outcomes ( including health-related quality of life -LSB- HRQoL -RSB- scores and mortality rates ) and costs ( standardized to @ dollars ) .


Regression models controlled for site and patient factors , with propensity matching used to adjust for differences in POAF versus no-POAF patients ' risk profiles .


Using the existing CABG trial database , @,@ patient records were analyzed , including POAF patients ( n = @ ) versus no-POAF patients ( n = @,@ ) .


For the index CABG hospitalization , POAF patients had longer postoperative length of stay ( +@ days ) and higher discharge costs ( + $ @,@ ) than no-POAF patients .


At @ year , POAF patients had more than twice the adjusted odds of dying ( p < @ ) , with higher @-year total cumulative costs .


This @-year cost difference ( + $ @,@ ) was largely attributable to hospital-based costs during the index surgery hospitalization .


There was no difference in @-year HRQoL scores ( or HRQoL score changes ) between POAF patients and no-POAF patients .


Compared with no-POAF patients , POAF patients had higher discharge and @-year costs along with higher @-year mortality rates , but no differences were observed in @-year HRQoL scores .


Additional research appears warranted to improve the longer-term survival rates for POAF CABG patients , targeting future POAF-specific postdischarge interventions .


Deficiency of vitamin D is an environmental risk factor for MS. Vitamin D has immunomodulatory effects , including promotion of T-cell differentiation into T-regulatory cells , which produces regulatory cytokines including TGF - .


Increasing serum vitamin D levels have been associated with decreased disease activity in MS patients , but there are only few studies concerning the immunological effects of vitamin D supplementation in MS. In this study we investigated the effect of weekly supplementation of vitamin D@ or placebo on serum levels of multiple cytokines in patients with relapsing remitting MS.


The study was conducted on the patient cohort of the Finnish Vitamin D study .


All patients were using IFN-beta-@b and were randomized to add-on treatment with either cholecalciferol @,@ IU/week or placebo .


Concentrations of LAP ( TGF - ) , INF - , IL-@A , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ and TNF - were determined at screening and at @ months using commercial fluorescent bead immunoassay kits .


LAP ( TGF - ) levels increased significantly in the vitamin D treated group from a mean of @ ( SE @ ) pg/ml to @ ( SE @ ) pg/ml in @ months ( p-value = @ ) .


Placebo treatment had no significant effect on LAP levels .


The levels of the other cytokines did not change significantly in either group .


We showed increased serum latency activated peptide ( LAP ) of TGF - levels in MS patients treated with vitamin D@ .


The immune regulatory effects of TGF-beta may play a role in the improved MRI outcomes that we observed earlier in the vitamin D treated group of patients .


Many patients with suspected non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) do not have significant coronary artery disease .


The current diagnostic approach of repeated electrocardiography and cardiac biomarker assessment requires observation for > @ to @ hours .


This strategy places a heavy burden on hospital facilities .


The objective of this study was to investigate whether myocardial strain assessment by echocardiography could exclude significant coronary artery stenosis in patients presenting with suspected NSTE-ACS .


Sixty-four patients presenting to the emergency department with suspected NSTE-ACS without known coronary artery disease , inconclusive electrocardiographic findings , and normal cardiac biomarkers at arrival were enrolled .


Twelve-lead electrocardiography , troponin T assay , and echocardiography were performed at arrival , and all patients underwent coronary angiography .


Significant coronary stenosis was defined as > @ % luminal narrowing .


Global myocardial peak systolic longitudinal strain was measured using speckle-tracking echocardiography .


Left ventricular ejection fraction and wall motion score index were calculated .


No significant stenosis in any coronary artery was found in @ patients ( @ % ) .


Global peak systolic longitudinal strain was superior to conventional echocardiographic parameters in distinguishing patients with and without significant coronary artery stenosis ( area under the curve , @ ) .


Sensitivity and specificity were calculated as @ and @ , respectively , and positive predictive value and negative predictive value as @ and @ , respectively .


Feasibility of the strain measurements was excellent , with @ % of segments analyzed .


Myocardial strain by echocardiography may facilitate the exclusion of significant coronary artery stenosis among patients presenting with suspected NSTE-ACS with inconclusive electrocardiographic findings and normal cardiac biomarkers .


Evidence-based treatments that achieve optimal energy intake and improve growth in preschool-aged children with cystic fibrosis ( CF ) are a critical need .


To test whether behavioral and nutritional treatment ( intervention ) was superior to an education and attention control treatment in increasing energy intake , weight z ( WAZ ) score , and height z ( HAZ ) score .


This randomized clinical trial included @ children aged @ to @ years ( mean age , @ years ) with CF and pancreatic insufficiency ( intervention , n = @ and control , n = @ ) .


The study was conducted at @ CF centers between January @ and November @ ; all @ participants who met intent-to-treat criteria completed through follow-up .


Behavioral intervention combined individualized nutritional counseling targeting increased energy intake and training in behavioral child management skills .


The control arm provided education and served as a behavioral placebo controlling for attention and contact frequency .


Both treatments were delivered in person or telehealth ( via telephone ) .


Sessions occurred weekly for @ weeks then monthly for @ months ( @ months ) .


Participants then returned to standard care for @ year , with @-month follow-up thereafter .


Changes in energy intake and WAZ score were examined from pretreatment to posttreatment ( @ months ) and change in HAZ score was assessed pretreatment to follow-up ( @ months ) .


Covariates included sex , Pseudomonas aeruginosa status at baseline , and treatment modality ( in person vs telehealth ) .


At baseline , mean ( SD ) energy intake was @ ( @ ) kcals/d , WAZ score was -@ ( @ ) , and HAZ score was -@ ( @ ) .


From pretreatment to posttreatment , the intervention increased daily energy intake by @ calories vs @ calories for the control group ( adjusted difference , @ calories ; @ % CI , @ to @ ; P < @ ) and increased the WAZ score by @ units vs @ for the control ( adjusted difference , @ ; @ % CI , -@ to @ ; P = @ ) .


From pretreatment to follow-up , the intervention increased the HAZ score by @ units vs -@ for the control ( adjusted difference , @ units ; @ % CI , @ to @ ; P = @ ) .


Measured treatment integrity and credibility were high for both groups .


Behavioral and nutritional intervention improved energy intake and HAZ score outcomes but not WAZ score outcomes .


Our results provide evidence that behavioral and nutritional treatment may be efficacious as a nutritional intervention for preschoolers aged @ to @ years with CF and pancreatic insufficiency .


This study describes the lifetime prevalence of teen dating violence ( TDV ) perpetration in a sample of middle school students from high-risk urban communities and examines the relation between TDV and related cognitive and behavioral risk factors .


Surveys were administered to @,@ middle school students in four U.S. cities ; @,@ students ( @ % ) reported having dated and were included in analyses .


The sample was @ % female , @ % non-Hispanic black/African-American , @ % Hispanic , @ % non-Hispanic white , and @ % other race .


Six types of TDV perpetration were assessed : threatening behaviors , verbal/emotional abuse , relational abuse , physical abuse , sexual abuse , and stalking .


Of the students who had dated , @ % reported perpetrating verbal/emotional abuse , @ % reported perpetrating physical abuse , @ % reported threatening a partner , @ % reported perpetrating sexual abuse , @ % reported perpetrating relational abuse , and @ % reported stalking .


Girls were more likely than boys to report perpetrating threatening behaviors , verbal/emotional abuse , and physical abuse , and boys were more likely to report perpetrating sexual abuse .


Involvement in bullying positively predicted perpetration of TDV , albeit , in different ways for boys and girls .


Other risk factors differed by sex .


For instance , alcohol use and sex initiation predicted multiple forms of TDV perpetration for boys , whereas weapon carrying and emotional symptoms predicted several forms of TDV perpetration for girls .


The prevalence of TDV was high in our sample .


Important sex differences in rates of perpetration and risk factors emerged .


Comprehensive prevention programs that target TDV and related risk factors , such as bullying and other risk factors , seem warranted .


The aim of the research was to indicate whether there are differences between locus of control ( LOC ) in girls with anorexia readiness syndrome ( ARS ) and without this syndrome .


There was also a question about the relationship between LOC and the tendency to respond in incorrect attitudes towards food , eating and their bodies under stress .


The sample consisted of girls aged @-@ years randomly selected from five public Polish middle and high schools .


Tools : @ ) Eating Attitudes Questionnaire ( EAQ ) by B. Zikowska ; @ ) Locus of Control Questionnaire ( LOCQ ) by G. Krasowicz , A. Kurzyp-Wojnarska , to assess LOC of the subjects .


The criterion group ( N = @ ) was formed by girls who received high score in EAQ ( signs of ARS ) in the first stage of research ( N = @ ) .


The control group ( N = @ ) were girls who received a low score in EAQ ( no signs of ARS ) .


Subjects with ARS were characterized by more external LOC than girls without any signs of this syndrome ( t = -@ ; p < @ ) .


The results did not confirm the hypothesis about the relationship between LOC and the tendency to respond by abnormal attitude to eating and own body in difficult situations in both groups .


In pathogenesis of ARS where anorexic behaviors can become a way to a regain lost control , LOC may play a role as a mediating variable rather than a direct determinant of this syndrome .


Adults with osteogenesis imperfecta ( OI ) have a high risk of fracture .


Currently , few treatment options are available , and bone anabolic therapies have not been tested in clinical trials for OI treatment .


@ adults with OI were randomized to receive @ g recombinant human parathyroid hormone ( teriparatide ) or placebo for @ months in a double-blind , placebo-controlled trial .


The primary endpoint was the percent change in areal bone mineral density ( aBMD ) of the lumbar spine ( LS ) , as determined by dual-energy X-ray absorptiometry .


Secondary endpoints included percent change in bone remodeling markers and vertebral volumetric BMD ( vBMD ) by quantitative computed tomography , estimated vertebral strength by finite element analysis , and self-reported fractures .


Compared with the placebo group , the teriparatide group showed increased LS aBMD ( @ % @ % vs. @ % @ % change from baseline ; P < @ ) and total hip aBMD ( @ % @ % vs. -@ % @ % change ; P < @ ) .


Vertebral vBMD and strength improved with teriparatide therapy ( @ % @ % and @ % @ % change , respectively ) , but declined with placebo ( -@ % @ % and -@ % @ % change ; P < @ for both comparisons ) .


Serum procollagen type @ N-terminal propeptide ( P@NP ) and urine collagen N-telopeptide ( NTx ) levels increased with teriparatide therapy ( @ % @ % and @ % @ % change , respectively ) .


Teriparatide-induced elevation of P@NP levels was less pronounced in severe forms of OI ( type III/IV ) compared with the milder form ( type I ) .


Type I OI patients exhibited robust BMD increases with teriparatide ; however , there was no observed benefit for those with type III/IV OI .


There was no difference in self-reported fractures between the @ groups .


Adults with OI , particularly those with less severe disease ( type I ) , displayed a teriparatide-induced anabolic response , as well as increased hip and spine aBMD , vertebral vBMD , and estimated vertebral strength .


Trial registration .


Clinicaltrials.gov NCT@ .


Funding .


The Osteoporosis Imperfecta Foundation , Eli Lilly and Co. , the National Center for Advancing Translational Science ( NCATS ) at the NIH ( grant no .


UL@RR@ ) , and the Baylor College of Medicine General Clinical Research Center ( grant no .


RR@ ) .


To evaluate the effects of remote ischemic preconditioning ( RIPC ) on the perioperative period in elective aortic valve replacement ( AVR ) along different anaesthesia techniques .


@ patients aged @ to @ years ( @ ( @ ; @ ) ) which were scheduled for AVR due to aortic valve stenosis were included into the prospective , randomized study .


Four groups were formed after randomization : @ ) RIPC applied during propofol anesthesia ( RIPCprop , n = @ ) , @ ) RIPC applied during sevoflurane anesthesia ( RIPCsevo , n = @ ) , @ ) propofol anesthesia without RIPC ( CONTROLprop , n = @ ) , @ ) sevoflurane anesthesia without RIPC ( CONTROLsevo , n = @ ) .


Groups were similar in baseline data of patients .


RIPC protocol : three five-minutes episodes of simultaneous both lower limbs ischemia with five-minutes reperfusion intervals .


Troponin I ( cTrI ) , interleukin-@ ( IL-@ ) , Interleukin-@ ( IL-@ ) and C-reactive protein ( CRP ) levels were assessed prior to induction of anesthesia , at @ min , @ , @ , @ and @ hours after the cessation of CPB .


Significant differences were assessed by the nonparametric Mann-Whitney and Fisher 's exact tests .


Data are presented as : median ( @th percentile , @th percentile ) .


Significant differences in cTnI were found between RIPCsevo and CONTROLsevo groups at @ , @ and @ hours : @ ( @ , @ ) ng/ml vs @ ( @ , @ ) ng/ml , respectively at @ hours ( p = @ ) ; @ ( @ , @ ) ng/ml vs @ ( @ , @ ) ng/ml , respectively at @ hours ( p = @ ) ; @ ( @ ; @ ) ng/ml vs @ ( @ ; @ ) ng/ml , respectively at @ hours ( p = @ ) .


There were no differences found in cTnI between RIPCprop and CONTROLprop groups during the whole study .


There were no significant differences found in the levels of IL-@ and CRP between RIPC and control groups during the whole study Unexpectedly significant excess concentrations of IL-@ at @ h were found when RIPC applied during sevoflurane anesthesia : @ ( @ , @ ) pg/mL in RIPCsevo group vs @ ( @ , @ ) pg/ml in CONTROLsevo group ( p = @ ) .


There was no paroxysmal atrial fibrillation ( AF ) after RIPC , and @ cases were registered in the control groups ( p = @ ) .


No other significant differences in the clinical course of the postoperative period were found .


Cardioprotective effect of RIPC and its effect on systemic inflammatory response should be assessed in the selected anesthesia groups .


RIPC on the background of sevoflurane anesthesia reduces myocardial injury during AVR .


RIPC does not reduce the severity of the systemic inflammatory response after AVR .


RIPC reduces the risk of AF after AVR .


The purpose of this study is to investigate potential associations between sympathoadrenal activation and/or vasopressor/inotropic therapy and endothelial activation , damage , and coagulopathy in septic patients .


Septic patients included in the Scandinavian Starch for Severe Sepsis/Septic Shock trial who were expected not to receive catecholamines at screening preintervention ( baseline ) and had baseline blood sampled .


Clinical , outcome data , and measurements of plasma concentration ( p - ) biomarkers reflecting sympathoadrenal activation , endothelial activation and damage , natural anticoagulation , fibrinolysis , cell damage , and platelet activation .


Sixty-seven patients were included , of whom @ turned out to receive noradrenaline infusion at blood sampling .


These @ patients had p-noradrenaline @-fold higher than patients not receiving catecholamines ( n = @ ) , whereas no other baseline preintervention biomarkers differed .


In the @ patients not receiving catecholamines at blood sampling , endogenous p-noradrenaline correlated positively with adrenaline , syndecan @ , soluble vascular endothelial growth factor receptor @ , soluble CD@ ligand , tissue-type plasminogen activator , and plasminogen activator inhibitor @ ( PAI-@ ) and negatively with PAI-@ / tissue-type plasminogen activator ratio ( all P < @ ) and was independently associated with syndecan @ , soluble vascular endothelial growth factor receptor @ , and PAI-@ ( all P < @ ) , and @ - and @-day mortality ( P < @ ) .


In septic patients , endogenous noradrenaline was independently associated with biomarkers of endothelial activation , damage , fibrinolysis and mortality , comparable with findings in trauma and myocardial infarction patients .


The catecholamine surge in critical illness may contribute to balance endothelial damage and procoagulation with hypocoagulability and hyperfibrinolysis in the circulating blood .


The objective was to determine the effects of omega-@ supplementation on nutritional state and inflammatory markers of hemodialysis patients .


This was a randomized , placebo-controlled trial .


Adult patients undergoing maintenance hemodialysis were included .


Patients with malignancy , pregnancy , concurrent inflammatory or infectious diseases , or concomitant use of any medication affecting inflammation status were excluded .


The omega-@ group received @ soft-gel capsules of fish oil ( @mg eicosapentaenoic acid and @mg docosahexaenoic acid in each ) daily for @months , and the placebo group received corresponding paraffin oil capsules.Nutrition indices including body mass index ; mid-arm muscle circumference ; serum concentrations of albumin , prealbumin , and transferrin ; and serum levels of inflammatory/anti-inflammatory markers including interleukin ( IL ) -@ , IL-@ , tumor necrosis factor ( TNF ) - , C-reactive protein , ferritin , parathyroid hormone , and ratios of IL-@ to TNF - and IL-@ to IL-@ were measured before and after @months of intervention .


Twenty patients in the placebo and @ patients in the omega-@ group completed the study .


There were no significant changes in nutritional markers between the omega-@ and placebo groups after @months of intervention .


Regression analysis adjusting post-treatment values of nutrition markers for baseline values , omega-@ treatment , and patients ' baseline demographic and clinical data revealed that omega-@ treatment was a significant independent predictor of increased serum prealbumin level ( @ ; @ % confidence interval @ , @ ; P = @ ) .


Although slight reduction of inflammatory state was observed in the omega-@ group , no significant differences were evident in the mean changes of inflammatory and anti-inflammatory markers between the @ groups with the exception of serum ferritin level and the IL-@ to IL-@ ratio , which significantly changed in favor of omega-@ supplementation ( P < @ and P = @ , respectively ) .


Omega-@ supplementation in hemodialysis patients produced a slight attenuation in systemic inflammation without any remarkable effects on nutritional markers .


To improve gait and balance in patients with Parkinson 's disease by combining anodal transcranial direct current stimulation with physical training .


In a double-blind design , one group ( physical training ; n = @ ) underwent gait and balance training during transcranial direct current stimulation ( tDCS ; real/sham ) .


Real stimulation consisted of @ minutes of @ mA transcranial direct current stimulation over primary motor and premotor cortex .


For sham , the current was switched off after @ seconds .


Patients received the opposite stimulation ( sham/real ) with physical training one week later ; the second group ( No physical training ; n = @ ) received stimulation ( real/sham ) but no training , and also repeated a sequential transcranial direct current stimulation session one week later ( sham/real ) .


Hospital Srio Libanes , Buenos Aires , Argentina .


Sixteen community-dwelling patients with Parkinson 's disease .


Transcranial direct current stimulation with and without concomitant physical training .


Gait velocity ( primary gait outcome ) , stride length , timed @-minute walk test , Timed Up and Go Test ( secondary outcomes ) , and performance on the pull test ( primary balance outcome ) .


Transcranial direct current stimulation with physical training increased gait velocity ( mean = @ % , SD = @ ; p < @ ) and improved balance ( pull test : mean = @ % , SD = @ ; p = @ ) compared with transcranial direct current stimulation alone .


There was no isolated benefit of transcranial direct current stimulation alone .


Although physical training improved gait velocity ( mean = @ % , SD = @ ; p = @ ) , these effects were comparatively less than with combined tDCS + physical therapy ( p < @ ) .


Greater stimulation-related improvements were seen in patients with more advanced disease .


Anodal transcranial direct current stimulation during physical training improves gait and balance in patients with Parkinson 's disease .


Power calculations revealed that @ patients per treatment arm ( = @ ; power = @ ) are required for a definitive trial .


The purpose of the study is to investigate the efficacy of an alpha-@ adrenergic receptor antagonist ( silodosin ) for the treatment of lower urinary tract symptoms ( LUTS ) associated with interstitial ( @ ) I implantation for prostate cancer .


This randomized single-center study involved @ patients ( @ with and @ without silodosin ) .


Silodosin was postoperatively administered , daily , for @ months ( @ mg/day ) .


Urinary symptoms and pressure flow were evaluated preoperatively and postoperatively at @ , @ , @ , and @ months .


At @ months , interstitial ( @ ) I implantation had induced a significant decrease in prostate volume ( @ @-@ @ @ g in the silodosin group and @ @-@ @ @ g in the controls ) and the prostate-specific antigen level ( @ @-@ @ @ ng/mL in the silodosin group and @ @-@ @ @ ng/mL in the controls ) .


Significant improvements in the international prostate symptom voiding subscores at @ months and quality of life at @ months were observed in those receiving silodosin .


The pressure flow studies demonstrated that silodosin had significantly enlarged the bladder capacity when the first non-voiding contraction was seen at @ and @ months ( @M : @ @ vs. @ @ mL , p = @ ; @M : @ @ vs. @ @ mL , p = @ ) ; however , there were no improvements in the bladder outlet obstruction index ( BOOI ) or urinary flow .


Silodosin temporarily improved LUTS , but did not improve the BOOI after ( @ ) I implantation in the prostate .


The purpose of this prospective and randomized clinical study was to assess differences in patient morbidity between minimally invasive lateral sinus elevation ( study group , n = @ ) and conventional one-stage lateral sinus elevation ( control group , n = @ ) .


It was hypothesized that trauma to soft tissue was reduced in the study group .


Optical @-D imaging was assessed blinded on days @ and @ after surgery to determine the visible soft tissue swelling of the upper lip and cheeks .


Postoperative pain and discomfort were evaluated by a visual analogue scale ( VAS ; scale @-@ ) .


Immediately and on day @ after surgery , the study group patients rated pain and discomfort as @ -LSB- SD @ -RSB- and @ -LSB- SD @ -RSB- , respectively , on the VAS ; while , the controls rated @ -LSB- SD @ -RSB- and @ -LSB- SD @ -RSB- , respectively .


The mean facial soft tissue volume change , assessed on day @ after surgery , was @ cm ( @ ) -LSB- range : @-@ @ -RSB- for the study group and @ cm ( @ ) ( @-@ @ ) for the controls ( p = @ ) .


Despite the small number of patients in this prospective study , @-D based minimally invasive one-stage lateral sinus elevation resulted in favourable patient morbidity with less postoperative visible facial soft tissue volume changes .


The purpose of this study was to investigate if differences in spinal height changes in healthy individuals were observed after a period of spinal unloading using repetitive as compared with sustained lumbar extension exercises .


This study used a pretest , posttest , crossover design .


Asymptomatic participants were recruited using convenience sampling .


Thirty-two participants ( @ male ; @ female ) without back pain were included in the data analysis ( mean , @ years ; range , @-@ years ) .


Participants performed sustained or repetitive prone lumbar extension exercises after @ hour of sustained spinal unloading .


Spinal height was measured using a stadiometer before and after the repetitive and sustained prone lumbar extension exercises .


Paired t tests revealed no significant difference in spine height after repetitive ( P = @ ) or sustained ( P = @ ) prone lumbar extension after a period of spinal unloading .


No significant difference between spinal height changes occurred between sustained ( mean -LSB- SD -RSB- , -@ -LSB- @ -RSB- mm ) and repetitive ( mean -LSB- SD -RSB- , -@ -LSB- @ -RSB- mm ) lumbar extension ( P = @ ) .


In this group of asymptomatic individuals , sustained and repetitive lumbar extension exercises did not appear to affect spinal height after a period of spinal unloading .


Skills in single-incision laparoscopic surgery ( SILS ) are difficult to acquire .


Simulation training leads to skill acquisition but circumstances about skill deterioration are unclear .


The aim of this study was to evaluate skill acquisition and retention after single-incision laparoscopic simulation training .


From October @ to January @ , @ surgically naive participants underwent a SILS training curriculum and completed two validated tasks ( peg transfer , precision cutting ) with subsequent testing to assess acquisition of skills ( baseline testing , BT ) .


The participants were randomized into two groups and skill retention testing ( RT ) was measured after @ weeks ( group A ) or @ weeks ( group B ) .


Task completion was measured in time with penalties for inaccurate performance .


A SILS training curriculum was established .


@ % of the participants completed the training successfully and reached the required levels of proficiency .


Comparison of BT and RT revealed significantly better RT performances for peg transfer and precision cutting in group A ( P < @ ) .


These effects were not seen for RT in group B. Evaluating the RT performance of both groups , group A showed a non-significant trend for improved peg transfer and precision cutting compared to group B.


A proficiency-based training curriculum for acquisition of basic SILS skills was successfully established in our department .


The results of this study indicate that acquired SILS skills are well retained for a short period without training ( @ weeks ) but a longer non-training period ( @ weeks ) resulted in a significant loss of acquired skills .


For enhancement of surgical skills , specialised SILS training curricula could be developed for novices and inexperienced surgeons ; however , continuous training is essential to maintain these acquired skills .


To reduce radiation exposure of frequently performed radiographs of the knee in follow-up of total-knee arthroplasty ensuring accurate assessment by using objective quality control criteria .


In this prospective randomized study @ radiographs of the knee in follow-up of total-knee arthroplasty were performed with standard and @ % reduced radiation dose .


The evaluation of the plain-radiographs was conducted using the following criteria : bone-implant interface , implant-surface character , implant-implant discrimination and periarticular heterotopic ossification .


Two radiologists evaluated these criteria using a score ranging from @ ( definitely assessable ) to @ ( not assessable ) .


If a single criterion had been evaluated with a score @ or more than @ criteria with @ points , the radiograph was score das `` not assessable '' .


The study was designed as non-inferiority-trial .


@ % of examined radiographs were scored as assessable , hence no statistical inferiority between the examinations with standard and reduced dose could be observed .


Singular assessment of the defined criteria was likewise dose-independent .


Plain-radiography of the knee following total-knee arthroplasty can be performed with @ % of standard dose without loss of diagnostic validity .


Due to the non-inferiority of digital radiographs of the knee joint after total-knee arthroplasty done with @ % reduced image receiver dose we recommend the tested speed class of SC @ as a new reference value for digital radiographs with this indication .


The present study was conducted to investigate the influence of different operating table heights on the quality of laryngeal view and the discomfort of the anaesthetist during enodotracheal intubation .


Eight anaesthetists participated , to each of whom @ patients were allocated .


Before induction of anaesthesia , the height of the operating table was adjusted to place the patient 's forehead at one of four landmarks on the anaesthetist 's body ( the order being determined by block randomization with eight blocks ) : umbilicus ( Group U ) , lowest rib margin ( Group R ) , xiphoid process ( Group X ) , and nipple ( Group N ) .


Next , the anaesthetist began the laryngoscopy and evaluated the grade of laryngeal view .


For this ` initial posture ' , the anaesthetist was not allowed to adjust his or her posture ( flexion or extension of the neck , lower back , knee , and ankle ) .


This laryngeal view was then re-graded after these constraints were relaxed .


At each posture , the anaesthetist 's joint movements and discomfort during mask ventilation or intubation were evaluated .


The laryngeal view before postural changes was better in Group N than in Group U ( P = @ ) .


The objective and subjective measurements of neck or lower back flexion during intubation were higher in Group U than in Groups X and N ( P < @ for each ) .


The improvement of laryngeal view resulting from postural changes correlated with the anaesthetist 's discomfort score before the postural change ( P < @ ) .


Higher operating tables ( at the xiphoid process and nipple level of the anaesthetist ) can provide better laryngeal views with less discomfort during tracheal intubation .


TRIAL REGISTRY NUMBER : NCT@ ( clinicaltrials.gov ) .


This study examines the efficacy of an online screening decision aid ( DA ) for men with a family history of prostate cancer .


Unaffected Australian men ( @-@ years ) with at least one affected relative completed the first online questionnaire , were randomized to read either the tailored DA ( intervention ) or nontailored information about prostate cancer screening ( control ) , then completed a questionnaire postreading and @ months later .


The primary outcome was decisional conflict regarding prostate specific antigen ( PSA ) testing .


The impact of the DA on longitudinal outcomes was analyzed by using random intercept mixed effects models .


Logistic and linear regressions were used to analyze the impact of the DA on screening behavior and decision regret .


Stage of decision-making was tested as a moderator for decisional conflict and decision regret .


The frequency of online material access was recorded .


The DA had no effect on decisional conflict , knowledge , inclination toward PSA testing , accuracy of perceived risk , or screening behavior .


However , among men considering PSA testing , those who read the DA had lower decision regret compared with men who read the control materials , = @ , p < @ , @ % confidence interval ( CI ) = -LSB- @ , @ -RSB- .


This is the first study to our knowledge to evaluate the uptake and efficacy of an online screening DA among men with a family history of prostate cancer .


Men who were undecided about screening at baseline benefitted from the DA , experiencing less regret @ months later .


In relation to decisional conflict , the control materials may have operated as a less complex and equally informative DA .


Despite decades of nutrition education , the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist .


Therefore , it is important to innovate and improve existing nutrition education interventions .


This paper describes the development , design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit , vegetable , high-energy snack and fat intake .


This intervention innovates existing computer-tailored interventions by not only targeting motivational factors , but also volitional and self-regulation processes and environmental-level factors .


The intervention development was guided by the Intervention Mapping protocol , ensuring a theory-informed and evidence-based intervention .


Two versions of the intervention were developed : a basic version targeting knowledge , awareness , attitude , self-efficacy and volitional and self-regulation processes , and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets .


Both versions consist of four modules : one for each dietary behavior , i.e. fruit , vegetables , high-energy snacks and fat .


Based on the self-regulation phases , each module is divided into three sessions .


In the first session , feedback on dietary behavior is provided to increase awareness , feedback on attitude and self-efficacy is provided and goals and action plans are stated .


In the second session goal achievement is evaluated , reasons for failure are explored , coping plans are stated and goals can be adapted .


In the third session , participants can again evaluate their behavioral change and tips for maintenance are provided .


Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline , @-month , @-months and @-months post-intervention , using online questionnaires .


Both versions will be compared with a generic nutrition information control condition .


The primary outcomes are fruit , vegetable , high-energy snack and fat intake .


The evaluation study will provide insight into the short - and long-term efficacy of both intervention versions in adults .


Additionally , differences in the efficacy among high - and low-educated people will be examined .


If these interventions are effective , two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high - and low-educated adults in the Netherlands .


Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies .


Although typically asymptomatic , lymphoceles can superinfect requiring medical or surgical intervention .


A single center randomized controlled trial provided first evidence , that a collagen-fibrin patch ( Tachosil ) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy .


We will perform a multicentre , blinded , randomized , controlled trial comprising @ women with gynecologic malignancies undergoing pelvic lymphadenectomy .


Women will be randomly allocated to Tachosil application or no application .


Primary outcome is efficacy , defined as lymphocele CTCAE @ grade @ within four weeks after surgery .


Secondary outcomes are asymptomatic lymphocele verified by ultrasound , medical or surgical intervention .


Assuming a two-sided @ % significance level , a power of @ % , and a drop out rate of @ % , a sample size of @ patients per group was calculated to detect a @ % absolute decrease in symptomatic lymphoceles .


We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy .


South African alcohol-serving establishments ( i.e. , shebeens ) offer unique opportunities to reduce HIV risks among men who drink .


To test an individual - and a social structural-level HIV prevention intervention for men who drink in shebeens .


Twelve matched pairs of township neighbourhoods were randomized to receive either ( i ) an HIV prevention intervention ( guided by Social Action Theory ) to reduce sexual risk and increase risk reduction communication in social networks , or ( ii ) an attention-matched control intervention that focused on the prevention of relationship violence .


At the individual level , the interventions delivered skills building workshops focused on sexual risk reduction .


At the social structural level , the intervention aimed to increase conversations about safer sex among men in the shebeens , distributed small media and implemented community educational events .


Individual-level outcomes were assessed by following the workshop cohorts for @ year ( N = @ ) , and community-level outcomes were examined through cross-sectional community surveys conducted for @ year in the shebeens ( N = @,@ ) .


Men in the HIV prevention workshops demonstrated greater condom use , more HIV prevention-oriented conversations and greater perceptions of safer sex norms than men in the comparison workshops .


Changes at the community level demonstrated significant differences in condom use , although the pattern was not consistent over time .


Multi-level interventions that target men who drink in South African shebeens may help reduce risks for HIV and other sexually transmitted infections .


There is no standardized method for cold pressor pain tasks across experiments .


Temperature , apparatus and aspects of experimenters vary widely among studies .


It is well known that experimental pain tolerance is influenced by setting as well as the sex of the experimenter .


It is not known whether other contextual factors influence experimental pain reporting .


The present two-part experiment examines whether minimizing and standardizing interactions with laboratory personnel ( eg , limiting interaction with participants to consenting and questions and not during the actual pain task ) eliminates the influence of examiner characteristics on subjective pain reports and whether using different cold pain apparatus ( cooler versus machine ) influences reports .


The present experiment manipulated the gender of the experimenter ( male , female and transgender ) and the type of cold pressor task ( CPT ) apparatus ( ice cooler versus refrigerated bath circulator ) .


Participants conducted the CPT at one of two pain levels ( @C or @C ) without an experimenter present .


Men and women showed lower pain sensitivity when they were processed by biological male personnel than by biological female personnel before the CPT .


Women who interacted with a transgendered researcher likewise reported higher pain sensitivity than women processed by biological male or female researchers .


The type of CPT apparatus , despite operating at equivalent temperatures , also influenced subjective pain reports .


The findings show that even minimal interactions with laboratory personnel who differ in gender , and differences in laboratory materials impact the reliable measurement of pain .


More standardized protocols for measuring pain across varying research and clinical settings should be developed .


Alteplase is the only approved thrombolytic agent for acute ischaemic stroke .


The overall benefit from alteplase is substantial , but some evidence indicates that alteplase also has negative effects on the ischaemic brain .


Tenecteplase may be more effective and less harmfull than alteplase , but large randomised controlled phase @ trials are lacking .


The Norwegian Tenecteplase Stroke Trial ( NOR-TEST ) aims to compare efficacy and safety of tenecteplase vs. alteplase .


NOR-TEST is a multi-centre PROBE ( prospective randomised , open-label , blinded endpoint ) trial designed to establish superiority of tenecteplase @ mg/kg ( single bolus ) as compared with alteplase @ mg/kg ( @ % bolus +@ % infusion/@minutes ) for consecutively admitted patients with acute ischaemic stroke eligible for thrombolytic therapy , i.e. patients a ) admitted < @hours after symptoms onset ; b ) admitted < @hours after awakening with stroke symptoms c ) receiving bridging therapy before embolectomy.Randomisation tenecteplase : alteplase is @:@ .


The primary study endpoint is favourable functional outcome defined as modified Rankin Scale @-@ at @days .


Secondary study endpoints are : @ ) haemorrhagic transformation ( haemorrhagic infarct/haematoma ) ; @ ) symptomatic cerebral haemorrhage on CT @-@ hours ; @ ) major neurological improvement at @hours ; @ ) recanalisation at @-@ hours ; @ ) death .


NOR-TEST may establish a novel approach to acute ischaemic stroke treatment .


A positive result will lead to a more effective , safer and easier treatment for all acute ischaemic stroke pasients.NOR-TEST is reviewed and approved by the Regional Committee for Medical and Health Research Ethics ( @/@ ) , and The Norwegian Medicines Agency ( @/@ ) .


NOR-TEST is registered with EudraCT No @-@-@ and in ClinicalTrials.gov ( NCT@ ) .


The intensity of pain after cardiac surgery is often underestimated , and inadequate pain control may be associated with poorer quality of recovery .


The aim of this investigation was to examine the effect of intraoperative methadone on postoperative analgesic requirements , pain scores , patient satisfaction , and clinical recovery .


Patients undergoing cardiac surgery with cardiopulmonary bypass ( n = @ ) were randomized to receive methadone ( @ mg/kg ) or fentanyl ( @ g/kg ) intraoperatively .


Postoperative analgesic requirements were recorded .


Patients were assessed for pain at rest and with coughing @min and @ , @ , @ , @ , @ , @ , and @h after tracheal extubation .


Patients were also evaluated for level of sedation , nausea , vomiting , itching , hypoventilation , and hypoxia at these times .


Postoperative morphine requirements during the first @h were reduced from a median of @mg in the fentanyl group to @mg in the methadone group ( median difference -LSB- @ % CI -RSB- , -@ -LSB- -@ to -@ -RSB- mg ; P < @ ) .


Reductions in pain scores with coughing were observed during the first @h after extubation ; the level of pain with coughing at @h was reduced from a median of @ in the fentanyl group to @ in the methadone group ( -@ -LSB- -@ to -@ -RSB- ; P < @ ) .


Improvements in patient-perceived quality of pain management were described in the methadone group .


The incidence of opioid-related adverse events was not increased in patients administered methadone .


Intraoperative methadone administration resulted in reduced postoperative morphine requirements , improved pain scores , and enhanced patient-perceived quality of pain management .


Involving family as part of the patient 's rehabilitation plan of care might enhance the management of COPD .


The primary aim of this study was to investigate the impact of a family-based pulmonary rehabilitation ( PR ) program on patients and family members ' coping strategies to manage COPD .


Family dyads ( patient and family member ) were randomly assigned to family-based ( experimental ) or conventional ( control ) PR .


Patients from both groups underwent exercise training three times a week and psychosocial support and education once a week , during @ weeks .


Family members of the family-based PR attended the psychosocial support and education sessions together with patients .


In the conventional PR , family members did not participate .


Family coping and psychosocial adjustment to illness were assessed in patients and family members of both groups .


Patients ' exercise tolerance , functional balance , muscle strength , and health-related quality of life were also measured .


All measures were collected pre/post-program .


Forty-two dyads participated ( patients : FEV@ , @ % @ % predicted ) .


Patients ( P = @ ) and family members ( P = @ ) in the family-based PR had significantly greater improvements in family coping than the control group .


Family members of the family-based PR had significantly greater changes in sexual relationships ( P = @ ) and in psychologic distress ( P = @ ) compared with the control group .


Patients from both groups experienced significant improvements in exercise tolerance , functional balance , knee extensors strength , and health-related quality of life after intervention ( P < @ ) .


This research supports family-based PR programs to enhance coping and psychosocial adjustment to illness of the family system .


The Italian Association of Medical Physics ( AIFM ) started a working group dedicated to stereotactic body radiotherapy ( SBRT ) treatment .


In this work , we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals .


Fourteen centers were provided the contours of @ patients .


Plans were performed following the dose prescription and constraints for organs at risk ( OARs ) of a reference paper .


The dose prescription was @ Gy in five fractions for the planning target volume ( PTV ) .


Different techniques were used ( @D-CRT , fixed-Field IMRT , VMAT , CyberKnife ) .


Plans were compared in terms of dose-volume histogram ( DVH ) parameters .


Furthermore , the median DVH was calculated and one patient was re-planned .


A total of @ plans were compared .


The maximum dose to the body was @ % ( range @-@ @ % ) .


Dose at @ % ( D@ % ) and mean dose to the clinical target volume ( CTV ) were @ % ( global range @-@ @ % ) and @ % ( range @-@ @ % ) .


Similar trends were found for D@ % and mean dose to the PTV .


Important differences were found in terms of the homogeneity index .


Doses to OARs were heterogeneous .


The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group .


In the re-optimized plans , DVH differences among institutes were reduced and OAR sparing improved .


Important dosimetric differences with possible clinical implications , in particular related to OARs , were found .


Replanning allowed a reduction in the OAR dose and decreased standard deviations .


Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure .


Delayed gastric emptying symptoms interfere with the absorption of oral medications .


Intranasal metoclopramide is being developed as an alternative to oral metoclopramide for patients with diabetic gastroparesis .


To compare the efficacy and safety of metoclopramide nasal spray to oral tablets in diabetic patients with symptoms of gastroparesis , this randomized , open-label , parallel design study randomized subjects to @ or @ mg nasal spray or @ mg tablet four times a day for @ weeks .


Efficacy was evaluated using a total symptom score ( TSS ) .


Eighty-nine subjects were enrolled .


For the intention to treat population , both nasal dose groups ( @ and @ mg ) had lower TSS with treatment compared to the oral @ mg group .


The change from baseline in TSS for nasal @ mg was greater than the oral @ mg at Week @ ( p = @ ) .


For the per-protocol population , there was a significant difference in the TSS between baseline and Week @ for both the nasal @ mg ( p = @ ) and the nasal @ mg ( p = @ ) cohorts compared to the oral @ mg group .


Based on the definition of a responder , @ % of subjects who received oral @ mg , @ % who received nasal @ mg , and @ % who received nasal @ metoclopramide were classified as responders .


The side-effect profile of the metoclopramide nasal spray was favorable .


More side effects , especially nausea , occurred with the oral tablets .


Metoclopramide nasal spray offers better symptom control than metoclopramide oral tablet in diabetic patients with symptoms of gastroparesis .


A previous randomized study showed that clarithromycin decreases the risk of death due to ventilator-associated pneumonia and shortens the time until infection resolution .


The efficacy of clarithromycin was tested in a larger population with sepsis .


Six hundred patients with systemic inflammatory response syndrome due to acute pyelonephritis , acute intra-abdominal infections or primary Gram-negative bacteraemia were enrolled in a double-blind , randomized , multicentre trial .


Clarithromycin ( @ g ) was administered intravenously once daily for @ days consecutively in @ patients ; another @ patients were treated with placebo .


Mortality was the primary outcome ; resolution of infection and hospitalization costs were the secondary outcomes .


The groups were well matched for demographics , disease severity , microbiology and appropriateness of the administered antimicrobials .


Overall @ day mortality was @ % ( @ deaths ) in the placebo arm and @ % ( @ deaths ) in the clarithromycin arm ( P = @ ) .


Nineteen out of @ placebo-treated patients with septic shock and multiple organ dysfunctions died ( @ % ) compared with @ out of @ clarithromycin-treated patients ( @ % , P = @ ) .


The median time until resolution of infection was @ days in both arms .


In the subgroup with severe sepsis/shock , this was @ days in the placebo arm and @ days in the clarithromycin arm ( P = @ ) .


The cost of hospitalization was lower after treatment with clarithromycin ( P = @ ) .


Serious adverse events were observed in @ % and @ % of placebo - and clarithromycin-treated patients , respectively ( P = @ ) .


Intravenous clarithromycin did not affect overall mortality ; however , administration shortened the time to resolution of infection and decreased the hospitalization costs .


The rate and effect of coronary interventions and induced hypothermia after out-of-hospital cardiac arrest ( OHCA ) are unknown .


We measured the association of early ( @h after arrival ) coronary angiography , reperfusion , and induced hypothermia with favorable outcome after OHCA .


We performed a secondary analysis of a multicenter clinical trial ( NCT@ ) conducted between @ and @ in @ North American regions .


Subjects were adults ( @ years ) hospitalized after OHCA with pulses sustained @min .


We measured the association of early coronary catheterization , percutaneous coronary intervention , fibrinolysis , and induced hypothermia with survival to hospital discharge with favorable functional status ( modified Rankin Score@ ) .


From @,@ OHCA subjects , @ ( @ % ) arrived at @ hospitals with sustained pulses .


@ ( @ % ) survived to hospital discharge , with @ ( @ % ) favorable outcomes .


Rates of early coronary catheterization ( @ % ) , coronary reperfusion ( @ % ) or induced hypothermia ( @ % ) varied among hospitals , and were higher in hospitals treating more subjects per year .


Odds of survival and favorable outcome increased with hospital volume ( per @ subjects/year OR @ ; @ % CI : @-@ @ and OR @ ; @ % CI : @ , @ , respectively ) .


Survival and favorable outcome were independently associated with early coronary angiography ( OR @ ; @ % CI @-@ @ and OR @ ; @ % CI @-@ @ ) , coronary reperfusion ( OR @ ; @ % CI @-@ @ and OR @ ; @ % CI @-@ @ ) , and induced hypothermia ( OR @ ; @ % CI @-@ @ and OR @ ; @ % CI @-@ @ ) .


Early coronary intervention and induced hypothermia are associated with favorable outcome and are more frequent in hospitals that treat higher numbers of OHCA subjects per year .


Previous studies conducted on animals linked consumption of Nigella sativa L. seeds ( NS ) to decreased anxiety and improved memory .


The present study , which was carried out at a boarding school in Bangladesh , was designed to examine probable effect of NS on mood , anxiety and cognition in adolescent human males .