Most subjects with bronchospasm responded to rescue bronchodilator within @hr .


No treatment-related serious AE occurred .


Although inhaled loxapine is contraindicated in patients with active airways disease per the current approved US labeling , these studies demonstrated that rescue bronchodilator mitigated the symptomatic bronchospasms that may occur in case of inadvertent use .


Forced expiratory volume in @s/forced expiratory volume in @s ( FEV@/FEV@ ) assessment with a microspirometer may be useful in the diagnostic work up of subjects who are suspected of having COPD in primary care .


To determine the diagnostic accuracy of a negative pre-bronchodilator ( BD ) microspirometry test relative to a full diagnostic spirometry test in subjects in whom general practitioners ( GPs ) suspect airflow obstruction .


Cross-sectional study in which the order of microspirometry and diagnostic spirometry tests was randomised .


Study subjects were ( ex - ) smokers aged @ years referred for diagnostic spirometry to a primary care diagnostic centre by their GPs .


A pre-BD FEV@/FEV@ value < @ as measured with the PiKo-@ microspirometer was compared with a post-BD FEV@/FVC ( forced vital capacity ) < @ and FEV@/FVC < lower limit of normal ( LLN ) from diagnostic spirometry .


One hundred and four subjects were analysed ( @ % males , @ % current smokers ) .


Negative predictive values from microspirometry for airflow obstruction based on the fixed and LLN cut-off points were @ % ( @ % confidence interval ( CI ) , @-@ @ ) and @ % ( @ % CI , @-@ @ ) , respectively .


In all , @ % of positive microspirometry results were not confirmed by a post-BD FEV@/FVC < @ and @ % of tests were false positive compared with the LLN criterion for airflow obstruction .


Pre-bronchodilator microspirometry seems to be able to reliably preselect patients for further assessment of airflow obstruction by means of regular diagnostic spirometry .


However , use of microspirometry alone would result in overestimation of airflow obstruction and should not replace regular spirometry when diagnosing COPD in primary care .


Older patients with a distal symmetric polyneuropathy are at markedly increase risk for falls and fall-related injuries .


Despite this , few studies have investigated the effect of exercise regimens on gait and balance in this high-risk group .


One hundred older patients with distal symmetric polyneuropathy were randomized to one of three interventions : functional balance training , Tai Chi , or education-only control .


The subjects in each group received instruction in ten @-hr weekly sessions .


Outcome measures were determined at baseline and the end of the @-wk intervention .


Gait , balance , and falls self-efficacy were assessed with various well established clinical ( Berg Balance Scale , @ Foot Up and Go Test , and Modified Falls Efficacy Scale ) and laboratory-based measures ( three-dimensional gait analysis and NeuroCom limits of stability and sensory organization tests ) .


The Tai Chi subjects demonstrated a decreased ( faster ) Timed Up and Go and increased stride length and time spent in single limb support at the end of intervention as compared with baseline .


The functional balance training group demonstrated a significant increase in ankle plantar flexor power and near significant decreases in step width and step width variability .


No changes in the education-only control group were observed .


Older patients with distal symmetric polyneuropathy may benefit from Tai Chi and/or functional balance training , with the former improving functional mobility and gait and the latter possibly improving trunk stabilization and forward progression ( Lythgo N , Cofr LE : Relationship between ankle plantar flexor power and EMG muscle activity during gait .


@th Annual Conference of Biomechanics in Sports -LSB- Melbourne , @ -RSB- .


Available at : https://ojs.ub.uni-konstanz.de/cap/article/viewFile/@/@ ) .


Whether these laudable changes can be maintained or translate into decreased risk for falls and fall-related injuries is unknown .


There are limited data on the role of antireflux biliary stents .


This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents ( pcARMS ) with that of standard uncovered self-expandable metal stents ( ucSEMS ) for the palliation of nonhilar malignant biliary obstruction .


Between August @ and February @ , patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS.Subsequent follow-up was conducted in clinic or by phone .


The primary outcome was onset of cholangitis within @ months of stenting .


Secondary outcomes included other morbidities , stent dysfunctions , and survival .


Altogether @ patients were included , @ in each group.The stents were successfully deployed in all patients .


Satisfactory jaundice control was achieved in @ cases in the pcARMS group , compared with @ in the ucSEMS group ( P = @ ) .


Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group ( @ vs. @ patients ; P = @ ) , and the frequency of episodes was less ( P = @ ) .


Respectively , @ and @ stent dysfunctions before death were observed in the pcARMS and ucSEMS groups ( P = @ ) and the median stent patency was @ ( standard deviation -LSB- SD -RSB- @ ) and @ ( @ ) months , respectively ( P = @ ) .


At final follow-up , in January @ , @/@ and @/@ patients had died and no difference in median survival was seen between the two groups ( @ vs. @ months , P = @ ) .


Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency , but does not increase patient survival .


Chictr.org .


number , ChiCTR-TRC-@ .


Coronary artery disease ( CAD ) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus , yet CAD often is asymptomatic prior to myocardial infarction ( MI ) and coronary death .


To assess whether routine screening for CAD by coronary computed tomography angiography ( CCTA ) in patients with type @ or type @ diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes .


The FACTOR-@ study was a randomized clinical trial in which @ patients with type @ or type @ diabetes of at least @ to @ years ' duration and without symptoms of CAD were recruited from @ clinics and practices of a single health system ( Intermountain Healthcare , Utah ) , enrolled at a single-site coordinating center , and randomly assigned to CAD screening with CCTA ( n = @ ) or to standard national guidelines-based optimal diabetes care ( n = @ ) ( targets : glycated hemoglobin level < @ % , low-density lipoprotein cholesterol level < @ mg/dL , systolic blood pressure < @ mm Hg ) .


All CCTA imaging was performed at the coordinating center .


Standard therapy or aggressive therapy ( targets : glycated hemoglobin level < @ % , low-density lipoprotein cholesterol level < @ mg/dL , high-density lipoprotein cholesterol level > @ mg/dL -LSB- women -RSB- or > @ mg/dL -LSB- men -RSB- , triglycerides level < @ mg/dL , systolic blood pressure < @ mm Hg ) , or aggressive therapy with invasive coronary angiography , was recommended based on CCTA findings .


Enrollment occurred between July @ and May @ , and follow-up extended to August @ .


The primary outcome was a composite of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization ; the secondary outcome was ischemic major adverse cardiovascular events ( composite of CAD death , nonfatal MI , or unstable angina ) .


At a mean follow-up time of @ ( SD , @ ) years , the primary outcome event rates were not significantly different between the CCTA and the control groups ( @ % -LSB- @ events -RSB- vs @ % -LSB- @ events -RSB- ; hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups ( @ % -LSB- @ events -RSB- vs @ % -LSB- @ events -RSB- ; hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Among asymptomatic patients with type @ or type @ diabetes , use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization at @ years .


These findings do not support CCTA screening in this population .


Using the Oslo Study of @-@ , we wished to compare the long-term mortality pattern up to @ years , in both the healthy cardiovascular groups at supposedly high and low risk , and in some groups having cardiovascular disease at screening .


At the screening , @,@ ( @ % of those invited ) men aged @-@ years participated .


Study groups were identified by means of questionnaires regarding diseases , blood pressure and measurements of total cholesterol , triglycerides and glucose .


We identified six groups : very high cholesterol , very high blood pressure , very high glucose , non-smoking with non-elevated such risk factors , from a randomized diet and antismoking trial , and a randomized drug treatment in mild-to-moderate hypertension .


Statistical analyses were by Cox regression analysis , with Kaplan-Meier graphs .


The supposedly low-risk group had a total mortality of one-third of other groups , such as : men with hypertension , diabetes or hypercholesterolemia , or those whom participated in the two trials .


Between these latter groups , we found @-@ years of difference in their median survival time , but their absolute risk stayed at rather high levels through all the years , with the median remaining a lifetime that was @-@ years shorter than the men whom were free of known cardiovascular disease , diabetes or hypertension .


The long-term preventive effects on total mortality seem large , if the levels of the classical risk factors of blood pressure , total cholesterol and glucose can be adequately controlled , concurrently with a non-smoking behavior .


The study indicated that non-smoking and a low total cholesterol value were the most important contributors to extended survival .


Shortening the course of treatment for tuberculosis would be a major improvement for case management and disease control .


This phase @ trial assessed the efficacy and safety of a @-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis .


We conducted a noninferiority , randomized , open-label , controlled trial involving patients @ to @ years of age with smear-positive , rifampin-sensitive , newly diagnosed pulmonary tuberculosis in five sub-Saharan African countries .


A standard @-month regimen that included ethambutol during the @-month intensive phase was compared with a @-month regimen in which gatifloxacin ( @ mg per day ) was substituted for ethambutol during the intensive phase and was continued , along with rifampin and isoniazid , during the continuation phase .


The primary efficacy end point was an unfavorable outcome ( treatment failure , recurrence , or death or study dropout during treatment ) measured @ months after the end of treatment , with a noninferiority margin of @ percentage points , adjusted for country .


A total of @ patients were assigned to the @-month regimen ( experimental group ) or the standard regimen ( control group ) .


Baseline characteristics were well balanced between the groups .


At @ months after the end of treatment , the adjusted difference in the risk of an unfavorable outcome ( experimental group -LSB- @ % -RSB- minus control group -LSB- @ % -RSB- ) in the modified intention-to-treat population ( @ patients ) was @ percentage points ( @ % confidence interval , -@ to @ ) .


There was heterogeneity across countries ( P = @ for interaction , with differences in the rate of an unfavorable outcome ranging from -@ percentage points in Guinea to @ percentage points in Senegal ) and in baseline cavitary status ( P = @ for interaction ) and body-mass index ( P = @ for interaction ) .


The standard regimen , as compared with the @-month regimen , was associated with a higher dropout rate during treatment ( @ % vs. @ % ) and more treatment failures ( @ % vs. @ % ) but fewer recurrences ( @ % vs. @ % ) .


There was no evidence of increased risks of prolongation of the QT interval or dysglycemia with the @-month regimen .


Noninferiority of the @-month regimen to the standard regimen with respect to the primary efficacy end point was not shown .


( Funded by the Special Program for Research and Training in Tropical Diseases and others ; ClinicalTrials.gov number , NCT@ . )


Malaria infections are the leading cause of death for children in Madagascar .


Insecticide-treated bednets offer effective prevention , but it is unclear how well free bednet distribution programs reach young children .


We conducted a secondary analysis of a free bednet distribution program in Madagascar from @-@ .


Interviews were performed at baseline and @ months .


Principal components analysis was used to construct a wealth and malaria knowledge index .


Coverage efficiency was calculated as coverage of children per bednet owned .


Univariable and multivariable regressions were used to determine predictors of bednet use .


Bednet use , among the @ households in the study , increased from @ to @ % after @ months .


Coverage efficiency increased from @ to @ children covered per bednet owned .


In multivariable analysis , having a child under @ years of age was the only variable associated with bednet use ( OR @ ; p = @ ) , yielding a @ % likelihood of using a bednet ( @ % CI @ to @ % ) versus @ % ( @ % CI @ to @ % ) in households without young children .


This free bednet distribution program achieved high levels of adherence after @ months .


Household presence of children was associated with bednet use , but not household income or education , suggesting that distribution to priority groups may help overcome traditional barriers to adoption in some settings .


To assess health-related quality of life ( HRQOL ) of subjects at risk of type @ diabetes undergoing lifestyle intervention , and predictors for improved HRQOL .


The Finnish Diabetes Risk Score was used by general practitioners to identify individuals at risk .


Low-intensity interventions with an @-month follow-up were employed .


HRQOL was assessed using the SF-@ at baseline and compared with results from a general Norwegian population survey and further at @ and @ months .


Simple and multiple linear regression analyses were applied to identify predictors of changes in HRQOL of clinical importance .


Two hundred and thirteen participants ( @ % women ; mean age : @ years , mean body mass index : @ ) were included : @ returned for @-month follow-up , of whom @ completed the HRQOL questionnaire .


HRQOL was reduced with clinical significance compared with general Norwegians .


The mean changes in HRQOL from the baseline to the follow-up were not of clinical importance .


However , one out of three individuals achieved a moderate or large clinical improvement in HRQOL .


The best determinant for improved HRQOL was obtained for a composite , clinically significant lifestyle change , i.e. both a weight reduction of at least @ % and an improvement in exercise capacity of at least @ % , which was associated with an improvement in five out of the eight SF-@ domains .


Subjects at risk of type @ diabetes report a clinically important reduction in HRQOL compared with general Norwegians .


The best predictor of improved HRQOL was a small weight loss combined with a small improvement in aerobic capacity .


The Nintendo Wii is a simple and affordable virtual therapy alternative .


It may be used at home , and it is a motivating recreational activity that provides continuous feedback .


However , studies comparing the use of the Nintendo Wii to conventional physical therapy are needed .


To compare the effect of a rehabilitation treatment using the Nintendo Wii ( NW ) with conventional physical therapy ( CPT ) to improve the sensorimotor function and quality of life for post-stroke hemiparetic patients .


The present study applied a randomized , blind , and controlled clinical trial .


In total , @ patients with post-stroke hemiparesis were evaluated .


A total of @ patients were randomly assigned to each group .


The SF-@ quality of life and Fugl-Meyer scales were used to evaluate the patients .


After treatment , the only variable that differed between the groups was the physical functioning domain of the SF-@ in the group that received conventional physical therapy .


A significant difference was observed between both groups before and after treatment in terms of the following Fugl-Meyer scale items : passive movement and pain , motor function of the upper limbs ( ULs ) , and balance .


The CPT group also showed a significant difference with regard to their UL and lower limb ( LL ) coordination .


The SF-@ scale analysis revealed a significant difference within both groups with regard to the following domains : physical functioning , role limitation due to physical aspects , vitality , and role limitation due to emotional aspects .


The NW group also exhibited a significant difference in the mental health domain .


The results indicate that both approaches improved the patients ' performance in a similar manner .


Virtual rehabilitation using the Nintendo Wii and CPT both effectively treat post-stroke hemiparetic patients by improving passive movement and pain scores , motor function of the upper limb , balance , physical functioning , vitality , and the physical and emotional aspects of role functioning .


The aims were to examine the effects of psychotherapy on depressive and anxiety symptoms , the occurrence of suicidal ideations and diurnal cortisol patterns in patients with adjustment disorder ( AD ) with depressed mood .


Participants recruited from an outpatient department of psychiatry at a general hospital were randomly assigned to one of two groups : @ in psychotherapy group and @ in control group .


The control group consisted of one-session psychoeducation .


Psychotherapy included the eight-weekly body-mind-spirit ( BMS ) group psychotherapy .


Measures included Beck Depression Inventory-II and State Trait Anxiety Inventory .


Salivary cortisol samples were collected from the patients at their homes on awakening ; @ and @ min after awakening ; and at @ , @ and @ h. Measurements were taken at baseline and at months @ ( end of intervention ) , @ , @ and @ .


There was no differential change over time between the BMS and control groups in self-reported depression or anxiety symptoms .


However , suicidal ideation appeared to be reduced in the psychotherapy group .


Changes in diurnal cortisol patterns were also significantly different in group time interactions , in favor of BMS group .


Psychotherapy likely provides improvements in psychobiological stress responses and decreases the occurrence of suicidal ideation in patients with AD .


In this paper , we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from @ clinical trials ( up to @ years of follow-up ) .


Healthy adult volunteers monitored annually for @ years after the administration of the first vaccine dose in @ double-blind , randomized clinical trials were included in this analysis .


Vaccination in these studies was administered according to a @-dose vaccination schedule : @ , @ months in study A and @ , @ months in study B ( NCT@/NCT@ ) .


Antibodies were measured using an in-house ELISA during the first @ years of follow-up ; a commercially available ELISA was then used up to Year @ of follow-up .


Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data .


Data from studies A and B were modeled separately .


A total of @ participants in study A and @ participants in study B were included in the analysis .


A linear mixed model with @ changepoints allowed all available results to be accounted for .


Predictions based on this model indicated that @ % ( @ % CI : @-@ % ) of participants in study A and @ % ( @ % CI : @-@ % ) of participants in study B will remain seropositive @ years after receiving the first vaccine dose .


Other models using part of the data provided consistent results : @ % of the participants was projected to remain seropositive for @ years .


This analysis , using previously used and newly selected model structures , was consistent with former estimates of seropositivity rates @ % for at least @ years .


The ultrasonic scalpel is a surgical shear that uses high-frequency mechanical energy to enable simultaneous vessel sealing and tissue coagulation at the same time .


We conducted a prospective study to compare the outcome of total thyroidectomy using the ultrasonic scalpel versus the device Ligasure in terms of safety , operative time , overall drainage volume , complications , hospital stay .


Between January @ and December @,@ patients ( @ women , @ men ; mean age @ years ) undergoing thyroidectomy were randomized into two groups : group A , where Ultracision were used , and group B , where the Ligasure device was used .


There was no significant differences between the two groups in terms of age , gender , indication for thyroidectomy , thyroid gland weight and diameter , histopathologic diagnosis , preoperative and postoperative serum calcium levels , postoperative complications and reoperative thyroid surgery , time of operation and amount of drainage .


The ultrasonic scalpel and the Ligasure ares safe , effective , useful , and time-saving alternative to the traditional suture ligation technique for thyroid surgery .


They simplified total thyroidectomy , eliminating the need for clamp-and-tie maneuvers while achieving efficient hemostasis .


To determine the effect of topical intranasal oxymetazoline on nasal resistance and aerobic exercise performance in patients with nasal congestion caused by inferior turbinate hypertrophy .


Individual randomized controlled trial .


Eight patients with inferior turbinate hypertrophy performed a set of exercise tests to exhaustion @ week apart .


They were given oxymetazoline or a placebo before each of the two test sessions according to a random pattern .


Changes in nasal airflow were measured as peak nasal flow and ventilatory efficiency parameters , ventilatory equivalents , end-expiratory pressure , oxygen consumption , cardiac efficiency , rate of perceived exertion , and maximal and submaximal mechanical power .


Ten minutes after use of the drug or placebo , improvements in maximum nasal airflow were seen in the oxymetazoline group ( P < @ ) .


However , exercise tests showed improvements in both groups ( P < @ ) .


After exertion , there was no difference between the two groups in maximum nasal airflow ( P > @ ) .


There were no differences between groups in oxygen consumption , rate of perceived exertion , respiratory exchange ratio , ventilation , or ventilatory equivalents for oxygen .


Oxymetazoline increased nasal airflow in patients with turbinate hypertrophy , but this change did not translate into gains in physical exercise parameters or perceived exertion .


Fibrous dysplasia ( FD ) is a rare skeletal disorder , resulting in deformity , fracture , functional impairment , and pain .


Bisphosphonates have been advocated as a potential treatment .


To determine the efficacy of alendronate for treatment of FD .


Two-year randomized , double-blind , placebo-controlled trial .


Clinical research center .


Forty subjects with polyostotic FD ( @ adults , @ children ) .


Subjects were randomized and stratified by age .


Study drug was administered over a @ month period in @ month cycles ( @ months on , @ months off ) .


Alendronate dosing was stratified : @ mg daily for subjects > @ kg , @ mg for @-@ kg , @ mg for @-@ kg .


Primary endpoints were bone turnover markers , including serum osteocalcin , and urinary NTX-telopeptides .


Secondary endpoints included areal bone mineral density ( aBMD ) , pain , skeletal disease burden score , and functional parameters including the @-min walk test and manual muscle testing .


Clinical data was collected on @ subjects who completed the study .


There was a decline in NTX-telopeptides in the alendronate group ( P = @ ) , but no significant difference in osteocalcin between groups .


The alendronate group had an increase in areal BMD in normal bone at the lumbar spine ( P = @ ) , and in predetermined regions of FD ( P < @ ) .


There were no significant differences in pain scores , skeletal disease burden scores , or functional parameters between the groups .


Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides , and improvement in aBMD , but no significant effect on serum osteocalcin , pain , or functional parameters .


The optimal postoperative analgesia after primary total hip arthroplasty remains in question .


This randomized , double-blind , placebo-controlled study compared the use of patient-controlled epidural analgesia ( PCEA ) with use of a multimodal pain regimen including periarticular injection ( PAI ) .


We hypothesized that PAI would lead to earlier readiness for discharge , decreased opioid consumption , and lower pain scores .


Forty-one patients received PAI , and forty-three patients received PCEA .


Preoperatively , both groups were administered dexamethasone ( @ mg , orally ) .


The PAI group received a clonidine patch and sustained-release oxycodone ( @ mg ) , while the PCEA group had placebo .


Both groups received combined spinal-epidural anesthesia and used an epidural pain pump postoperatively ; the PAI group had normal saline solution , while the PCEA group had bupivacaine and hydromorphone .


The primary outcome , readiness for discharge , required the discontinuation of the epidural , a pain score of < @ ( numeric rating scale ) without parenteral narcotics , normal eating , minimal nausea , urination without a catheter , a dry surgical wound , no acute medical problems , and the ability to independently transfer and walk @ m ( @ ft ) .


The mean time to readiness for discharge ( and standard deviation ) was @ @ days ( PAI ) compared with @ @ days ( PCEA ) ( p = @ ) .


The mean length of stay was @ @ days ( PAI ) compared with @ @ days ( PCEA ) ( p = @ ) .


A significant mean difference in pain score of @ with ambulation ( p = @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) and @ during physical therapy ( p = @ ; @ % CI , @ to @ ) favored the PCEA group .


The mean opioid consumption ( oral morphine equivalents in milligrams ) was significantly higher in the PAI group on postoperative day @ ( @ @ compared with @ @ ; p = @ ) and postoperative days @ through @ ( @ @ compared with @ @ ; p = @ ) .


Opioid-Related Symptom Distress Scale ( ORSDS ) composite scores for severity and bothersomeness as well as scores for nausea , vomiting , and itchiness were significantly higher in the PCEA group ( p < @ ) .


Quality of Recovery-@ scores and patient satisfaction were similar .


PAI did not decrease the time to discharge and was associated with higher pain scores and greater opioid consumption but lower ORSDS scores compared with PCEA .


The choice for analgesic regimen may depend on a particular patient 's threshold for pain and the potential side effects .


Benefits of the skeletonized internal thoracic artery ( ITA ) include increased graft flow , increased graft length , and reduced incidence of sternal complications .


We conducted a randomized , double-blinded comparison of skeletonized versus pedicled ITA to assess the differences in pain intensity and extent of disability between the two types of harvesting procedures at one and three months follow-up .


A total of @ patients were included in our study .


Twenty-five patients had undergone skeletonized grafting while the other half had undergone pedicled grafting .


The patients were evaluated for their pain at one and three months postoperatively .


Extent of disability was measured via Pain Disability Index and intensity of pain was measured via Visual Analogue Scale ( VAS ) .


The patients were also questioned about the details of their pain using Short Form McGill Pain Questionnaire .


In the first month , the mean pain intensity measured through VAS was @ and @ mm in skeletonized and pedicle group , respectively .


The pedicled group had significantly higher scores measured by all three scales at both one - and three-month intervals ( p-values < @ ) .


Our results indicate that skeletonization of ITA significantly reduces postcoronary artery bypass graft surgery pain at both one - and three-month intervals .


Long-term clinical trials involving larger sample sizes should be conducted to fully confirm the benefits of the skeletonization technique .


Allergen-specific immunotherapy ( SIT ) is the only intervention for IgE-mediated respiratory disorders .


The aim of the study was to investigate the immunological modifications induced by SIT in patients allergic to olive and/or grass pollen by attempting to establish an association between these modifications and clinical improvements .


We studied @ patients who were allergic to olive and/or grass pollen .


Patients were randomized to @ groups : an active treatment group , comprising @ allergic patients who received SIT , and a control group , formed by @ allergic patients who received pharmacological treatment for their allergic symptoms but not immunotherapy .


We used flow cytometry to analyze intracellular expression of the cytokines IL-@ , IFN-gamma , IL-@ , and TGF-beta@ in CD@ + T cells , as well as expression of Foxp@ , the costimulatory CTLA-@ molecule , and the non-costimulatory CD@L molecule .


To assess clinical changes , patients recorded their medication consumption , symptoms , and the limitation of daily activities using diary cards and quality of life questionnaires .


Six months after initiation of SIT , we recorded a reduction in cell surface CD@L expression in the CD@ + T-cell population and a shift in the cytokine production profile ( decrease in IL-@-producing CD@ + T cells and increase in IFN-gamma , IL-@ , and TGF-beta@ ) .


These changes persisted after @ months .


Simultaneously , a clinical improvement was observed .


SIT-induced clinical improvement is the result of immunological modifications such as a reduction in CD@L expression on CD@ cells and alteration in the cytokine production profile .


The luteal menstrual phase might be a favorable time for smoking cessation when non-nicotine interventions ( e.g. counseling , bupropion ) are used , whereas the follicular menstrual phase appears favorable when nicotine interventions are used .


Thus , there may be an interaction between menstrual phase and response to nicotine .


We sought to examine the role of menstrual phase on response to nicotine during acute smoking abstinence .


In this controlled cross-over trial , women completed two identical experimental sessions ( follicular -LSB- F -RSB- vs. luteal -LSB- L -RSB- phase ) after four days of biochemically-verified smoking abstinence .


During the sessions , nicotine nasal spray was administered , and participants provided a series of subjective assessments .


Participants ( n = @ ) were @ years old and smoked @ cigarettes per day .


Compared to the F phase , the L phase was associated with a greater increase in stimulation ( @ vs. @ , p = @ , respectively ) and greater decrease in urge to smoke ( -@ vs. -@ , p = @ , respectively ) after the first dose of nicotine .


No other significant differences were observed .


Out of @ total measures examined at two different time points , we observed only two significant menstrual phase differences in the subjective response to nicotine .


Therefore , these data do not provide strong evidence for a menstrual phase difference in the subjective response to nicotine .


Additional research is needed to confirm this relationship and explore how non-nicotine smoking reinforcements ( such as sensory sensations ) may vary by menstrual phase .


To compare the outcomes of congenital cataract surgery using intraoperative intracameral triamcinolone versus postoperative oral prednisolone to modulate ocular inflammation .


Department of Congenital Cataract , Altino Ventura Foundation , Recife , Brazil .


Randomized clinical trial .


Children younger than @ years were randomly divided into @ groups .


The study group received an intraoperative intracameral injection of @ mg/@ @ mL of triamcinolone acetonide .


The control group ( @ eyes ) received @ mg/kg per day of prednisolone syrup for @ days postoperatively , which was then tapered over the following @ weeks .


Intraocular pressure ( IOP ) , central corneal thickness ( CCT ) , cell deposits on the intraocular lens ( IOL ) , posterior synechiae , visual axis obscuration , additional surgical procedures , and IOL centration were assessed @ months postoperatively .


The mean patient age at surgery was @ months@ @ ( SD ) in the study group ( @ eyes ) and @ months in the control group ( @ eyes ) ( P = @ ) .


In both groups , the mean IOP and CCT did not change significantly postoperatively ( study group P = @ and P = @ , respectively ; control group P = @ and P = @ , respectively ) .


The groups had similar incidences of cell deposits ( P = @ ) and posterior synechiae ( P = @ ) .


No eye developed visual axis obscuration or had additional surgical procedures .


All eyes had a clinically centered IOL .


One year postoperatively , the outcomes were similar with intraoperative intracameral triamcinolone injection and postoperative oral prednisolone for modulating inflammation after congenital cataract surgery .


To assess the effect of preventive pravastatin treatment on coronary heart disease ( CHD ) morbidity and mortality in older persons at risk for cardiovascular disease ( CVD ) , stratified according to plasma levels of homocysteine .


A post hoc subanalysis in the PROspective Study of Pravastatin in the Elderly at Risk ( PROSPER ) , started in @ , which is a double-blind , randomized , placebo-controlled trial with a mean follow-up of @ years .


Primary care setting in two of the three PROSPER study sites ( Netherlands and Scotland ) .


Individuals ( n = @,@ , aged @-@ , @,@ male ) with a history of or risk factors for CVD were ranked in three groups depending on baseline homocysteine level , sex , and study site .


Pravastatin ( @ mg ) versus placebo .


Fatal and nonfatal CHD and mortality .


In the placebo group , participants with a high homocysteine level ( n = @ ) had a @ higher risk ( @ % confidence interval ( CI ) = @-@ @ , P = @ ) of fatal and nonfatal CHD than those with a low homocysteine level ( n = @ ) .


The absolute risk reduction in fatal and nonfatal CHD with pravastatin treatment was @ % ( @ % CI = -@ to @ % ) in the low homocysteine group and @ % ( @ % CI = @-@ @ % ) in the high homocysteine group ( difference @ % , @ % CI = @-@ @ , P = @ ) .


Therefore , the number needed to treat ( NNT ) with pravastatin for @ years for benefit related to fatal and nonfatal CHD events was @ ( @ % CI = @-@ @ ) for high homocysteine and @ ( @ % CI = @ - ) for low homocysteine .


In older persons at risk of CVD , those with high homocysteine are at highest risk for fatal and nonfatal CHD .


With pravastatin treatment , this group has the highest absolute risk reduction and the lowest NNT to prevent fatal and nonfatal CHD .


Current parameters for assessing the efficacy of actinic keratosis ( AK ) treatments compare clinical lesions at the start and end of a study .


However , the sun-exposed field also contains subclinical lesions which may become detectable during treatment .


Lmax , the maximum lesion count during treatment , is a new concept to better assess the efficacy of field-directed AK therapies .


Measuring efficacy using the reduction in lesions from Lmax includes for the first time the clearance of both subclinical and clinical lesions .


To evaluate the reduction of lesions from Lmax to study end and compare the results with traditional efficacy endpoints using imiquimod @ % ( IQ@ @ % ) as an example of field-directed AK therapy .


Pooled analysis of data from two @-week , vehicle-controlled , double-blind studies of IQ@ @ % .


With IQ@ @ % , the median number of lesions increased from @ at baseline to an Lmax of @ .


The median absolute reduction in lesions to study end was @ from Lmax versus @ from baseline .


The median percentage reduction in AK lesions to study end was @ % from Lmax compared with @ % from baseline .


The reduction in lesion count from Lmax is a novel efficacy parameter that should become the new way of evaluating field-directed AK therapies since it enables their efficacy against both clinical and subclinical lesions to be accurately determined .


Together , the Lmax concept and IQ@ @ % represent a new approach for the management of AK across a large sun-exposed field .


Individual work performance is an important outcome measure in studies in the workplace .


Nevertheless , its conceptualization and measurement has proven challenging .


To overcome limitations of existing scales , the Individual Work Performance Questionnaire ( IWPQ ) was recently developed .


The aim of the current study was to gain insight into the responsiveness of the IWPQ .


Data were used from the Be Active & Relax randomized controlled trial .


The aim of the trial was to investigate the effectiveness of an intervention to stimulate physical activity and relaxation of office workers , on need for recovery .


Individual work performance was a secondary outcome measure of the trial .


In total , @ hypotheses were formulated concerning correlations between changes on the IWPQ scales and changes on similar constructs ( e.g. , presenteeism ) and distinct constructs ( e.g. , need for recovery ) used in the trial .


@ Participants completed the IWPQ at both baseline and @ months of follow-up .


For the IWPQ scales , @ % , @ % , and @ % , respectively , of the hypotheses could be confirmed .


In general , the correlations between change scores were weaker than expected .


Nevertheless , at least @ % of the correlations were in the expected direction .


Based on results of the current study , no firm conclusions can be drawn about the responsiveness of the IWPQ .


Several reasons may account for the weaker than expected correlations .


Future research on the IWPQ 's responsiveness should be conducted , preferably in other populations and intervention studies , where greater changes over time can be expected .


To determine the efficacy of topical application of the autologous platelet gel ( PG ) in canine chronic protracted decubital ulcers .


Prospective , randomized , blind controlled clinical trial .


Dogs ( n = @ ) with bilateral chronic wounds caused by protracted decubitus ulcers .


For each dog , wound side was randomized to receive either platelet gel ( group PG ) every @ days for @ dressing changes , or paraffin gauzes dressings ( group C ) , as negative control .


Wound healing and wound surfaces were compared at admission and then evaluated every @th day , until day @ .


Outcome variables were : open wound area , reduction of open wound surface compared to admission and to each preceding dressing change , time to complete epithelialization .


Significant differences in healing process were observed at day @ and continued throughout the entire study period ( P < @ ) .


At @ days , mean percent reduction in wound area was @ % in group PG and @ % in group C ( P < @ ) .


Appropriately prepared autologous PG , an inexpensive , readily available blood derivative , applied topically results in more rapid healing of chronic non-healing decubital ulcers in dogs than those treated by use of paraffin-impregnated gauzes .


The randomised phase III TURANDOT trial compared first-line bevacizumab-paclitaxel ( BEV-PAC ) vs bevacizumab-capecitabine ( BEV-CAP ) in HER@-negative locally recurrent/metastatic breast cancer ( LR/mBC ) .


The interim analysis revealed no difference in overall survival ( OS ; primary end point ) between treatment arms ; however , progression-free survival ( PFS ) and objective response rate were significantly superior with BEV-PAC .


We sought to identify patient populations that may be most appropriately treated with one or other regimen .


Patients with HER@-negative LR/mBC who had received no prior chemotherapy for advanced disease were randomised to either BEV-PAC ( bevacizumab @ mg kg ( -@ ) days @ and @ plus paclitaxel @ mg m ( -@ ) days @ , @ and @ q@w ) or BEV-CAP ( bevacizumab @ mg kg ( -@ ) day @ plus capecitabine @ mg m ( -@ ) bid days @-@ q@w ) .


The study population was categorised into three cohorts : triple-negative breast cancer ( TNBC ) , high-risk hormone receptor-positive ( HR + ) and low-risk HR + .


High - and low-risk HR + were defined , respectively , as having @ vs @ of the following four risk factors : disease-free interval @ months ; visceral metastases ; prior ( neo ) adjuvant anthracycline and/or taxane ; and metastases in @ organs .


The treatment effect on OS differed between cohorts .


Non-significant OS trends favoured BEV-PAC in the TNBC cohort and BEV-CAP in the low-risk HR + cohort .


In all three cohorts , there was a non-significant PFS trend favouring BEV-PAC .


Grade @ adverse events were consistently less common with BEV-CAP .


A simple risk factor index may help in selecting bevacizumab-containing regimens , balancing outcome , safety profile and patient preference .


Final OS results are expected in @ ( ClinicalTrials.gov NCT@ ) .


The present study aims to explore the effects of vitamin E and omega-@ on endothelial function indicators among adolescents with metabolic syndrome .


In a randomized , double blind , and placebo-controlled trial , @ young individuals , aged @ to @ years , with metabolic syndrome were randomly assigned to receive either vitamin E tablets ( @IU/day ) or omega-@ tablets ( @ gr/day ) or placebo .


For assessing endothelial functional state , the serum level of vascular endothelial growth factor ( VEGF ) was measured by ELISA test .


The use of omega-@ supplementation for eight weeks led to significant increase in serum HDL level compared with the group treated with vitamin E or placebo group .


In this regard , no significant correlations were found between the change in VEGF and baseline levels of other markers including anthropometric indices and serum lipids .


Omega-@ could significantly reduce VEGF with the presence of other baseline variables ( Beta = -@ ; P = @ ) .


The administration of omega-@ can effectively improve endothelial function in adolescents with metabolic syndrome by reducing the level of serum VEGF , as a major index for atherosclerosis progression and endothelial destabilization .


Omega-@ can be proposed as a VEGF antagonist for improving endothelial function in metabolic syndrome .


The clinical implications of our findings should be assessed in future studies .


To evaluate the @-year efficacy and safety of once weekly exenatide .


The Diabetes Therapy Utilization : Researching Changes in A@C , Weight and Other Factors Through Intervention with Exenatide Once Weekly ( DURATION-@ ) randomized clinical trial consisted of a @-week controlled phase ( @ mg of exenatide once weekly vs @ g of exenatide twice daily ) with an open-ended uncontrolled extension ( once weekly exenatide only ) in patients with type @ diabetes mellitus on background glucose-lowering therapies ( April @ , @ , through February @ , @ ) .


At week @ , patients initially receiving @ g of exenatide twice daily switched to @ mg of exenatide once weekly .


Study end points included changes from baseline in hemoglobin A@c , fasting plasma glucose , weight , lipids , and blood pressure .


Long-term safety data included adverse events , liver and renal function , and heart rate .


Of @ extension-phase patients , @ ( @ % ) completed @ years of treatment .


Hemoglobin A@c levels were significantly and durably reduced from baseline ( least-squares mean , -@ % ; @ % CI , -@ % to -@ % ; vs -@ % for exenatide once weekly at week @ ) , and @ ( @ % ) of @ patients achieved hemoglobin A@c levels of less than @ % .


Significant improvements in fasting plasma glucose level ( -@ mg/dL ; @ % CI , -@ to -@ mg/dL ) , weight ( -@ kg ; @ % CI , -@ to -@ kg ) , lipids , and diastolic blood pressure were observed , with minimal heart rate increase .


Frequencies of nausea and injection-site reactions or nodules were decreased vs the initial @-week controlled phase .


Minor hypoglycemia occurred predominantly with sulfonylurea use , and no major hypoglycemia or new safety signals were observed .


Long-term once weekly exenatide treatment was generally well tolerated with sustained glycemic improvement , weight reduction , and improved markers of cardiovascular risk in patients with type @ diabetes .


The use of single-port laparoscopy for left-lateral liver sectionectomy ( LLLS ) has been reported in the literature , but the effectiveness and safety of LLLS has not been validated in randomized , controlled trials .


This prospective randomized controlled trial compared the effectiveness and safety of single-port and multi-port laparoscopic LLLS for the surgical treatment of benign liver disease .


Altogether , @ patients aged @-@ years ( @ men , @ women ) with benign liver diseases were hospitalized for elective laparoscopic LLLS between January @ and December @ .


Patients were randomly assigned to either single-port ( n = @ ) or multi-port ( n = @ ) laparoscopic LLLS .


Main outcome measures were operative time , volume of intraoperative blood loss , complication rates , and postoperative hospitalization .


Baseline characteristics of the two groups were comparable .


Single-port and multi-port laparoscopies were successfully completed in all but one patient ( @/@ , @ % ) who required conversion from a single-port to a multi-port procedure .


The two groups had similar mean operative times and volumes of intraoperative blood loss .


There were no clinically significant postoperative complications or deaths .


The single-port group had a significantly shorter postoperative hospitalization than the multi-port group ( @ @ vs. @ @ days ; p < @ ) .


Single-port laparoscopic LLLS is a technically feasible , effective , safe alternative to multi-port laparoscopy for the treatment of benign liver diseases in cautiously selected patients .


Behavioral interventions for obesity are commonly delivered in groups , although the effect of group size on weight loss has not been empirically evaluated .


This behavioral weight loss trial compared the @ - and @-month weight changes associated with interventions delivered in a large group ( LG ) or small groups ( SG ) .


Obese adults ( N = @ ; mean age = @ years ; mean BMI = @ kg/m@ ; @ % African American ; @ % women ) recruited from a health maintenance organization were randomly assigned to : ( @ ) LG treatment ( @ members/group ) , or ( @ ) SG treatment ( @ members/group ) .


Conditions were comparable in frequency and duration of treatment , which included @ weekly group sessions ( months @-@ ) followed by six monthly extended care contacts ( months @-@ ) .


A mixed effects model with unstructured covariance matrix was applied to analyze the primary outcome of weight change while accounting for baseline weight and dependence among participants ' measurements over time .


SG participants lost significantly more weight than LG participants at Month @ ( -@ vs. -@ kg ; p = @ ) and Month @ ( -@ vs. -@ kg ; p < @ ) .


SG participants reported better treatment engagement and self-monitoring adherence at Months @ and @ , ps < @ , with adherence fully mediating the relationship between group size and weight loss .


Receiving obesity treatment in smaller groups may promote greater weight loss and weight loss maintenance .


This effect may be due to improved adherence facilitated by SG interactions .


These novel findings suggest that the perceived efficiency of delivering behavioral weight loss treatment to LGs should be balanced against the potentially better outcomes achieved by a SG approach .


This research was conducted with the aim of determining the influence of three different oral care solutions on oral mucous membrane integrity in critically ill patients .


Oral care is a basic part of nursing care in intensive care units .


A randomized controlled trial was conducted .


A total of @ patients ( @ patients in each group ) comprised the study sample of the research .


Patients were randomly allocated to three groups .


Patients in groups @ , @ and @ were administered mouth care three times a day using @ % sodium bicarbonate , @ % chlorhexidine and saline solution , respectively .


Data were collected by means of a ` Descriptive characteristics form ' and an ` oral assessment tool ' .


Mean scores of oral assessment tool increased according to days in all groups , however , this increase was found to be statistically insignificant ( p > @ ) .


Mean scores of the patients in saline solution group were seen to be lower than those of the other groups .


When inter-group comparison of days was done , the difference between oral assessment scores was found to be statistically significant ( p = @ ) .


It was found that there was no difference between patient groups receiving saline solution , sodium bicarbonate and @ % chlorhexidine for mouth care in terms of oral mucous membrane integrity ; oral mucosa of all patients was found to be mildly dysfunctioning .


It is thought that standardized protocols for oral hygiene developed in the light of the findings of randomized controlled trials may improve the oral health in critically ill patients .


Angina pectoris is common in patients with heart failure and reduced ejection fraction ( HF-REF ) but its relationship with outcomes has not been well defined .


This relationship was investigated further in a retrospective analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure ( CORONA ) .


Four thousand , eight hundred and seventy-eight patients were divided into three categories : no history of angina and no chest pain at baseline ( Group A ; n = @ ) , past history of angina but no chest pain at baseline ( Group B ; n = @ ) and both a history of angina and chest pain at baseline ( Group C ; n = @ ) .


Outcomes were examined using Kaplan-Meier and Cox regression survival analysis .


Compared with Group A , Group C had a higher risk of non-fatal myocardial infarction or unstable angina ( HR : @ , @-@ @ ; P < @ ) , this composite plus coronary revascularization ( HR : @ , @-@ @ ; P < @ ) , as well as HF hospitalization ( HR : @ , @-@ @ ; P = @ ) , over a median follow-up period of @ months .


There was no difference in cardiovascular or all-cause mortality .


Group B had a smaller increase in risk of coronary events but not of heart failure hospitalization .


Patients with HF-REF and ongoing angina are at an increased risk of acute coronary syndrome and HF hospitalization .


Whether these patients would benefit from more aggressive medical therapy or percutaneous revascularization is not known and merits further investigation .


Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs , although a relevant role is now emerging for specific functional foods and nutraceuticals .


The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment .


Thirty patients with moderate dyslipidemia and metabolic syndrome ( according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection , Evaluation , and Treatment of High Blood Cholesterol in Adults ) were included in an @-week randomized , double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract , berberine , policosanol , astaxanthin , coenzyme Q@ , and folic acid ( Armolipid Plus ) .


Subsequently , they were subjected to another @-week treatment with pravastatin @ mg/d .


This dosage was selected on the basis of its expected -@ % efficacy in reducing low-density lipoprotein-cholesterol .


Treatment with Armolipid Plus led to a significant reduction of total cholesterol ( -@ % ) and low-density lipoprotein-cholesterol ( -@ % ) , similar to pravastatin ( -@ % and -@ % , respectively ) , and an increase of high-density lipoprotein-cholesterol ( @ % ) .


Armolipid Plus improved the leptin-to-adiponectin ratio , whereas adiponectin levels were unchanged .


These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment .


Hence , it may be a safe and useful option , especially in conditions of moderate cardiovascular risk , in which a pharmacologic intervention may not be appropriate .


Despite the prevalence and the functional , psychological , and economic impact of chronic pain , few intervention studies of treatment of chronic pain in veterans have been performed .


To determine whether a stepped-care intervention is more effective than usual care , as hypothesized , in reducing pain-related disability , pain interference , and pain severity .


We performed a randomized clinical trial comparing stepped care with usual care for chronic pain .


We enrolled @ veterans from Operation Enduring Freedom , Operation Iraqi Freedom , and Operation New Dawn with chronic ( > @ months ) and disabling ( Roland Morris Disability Scale score , @ ) musculoskeletal pain of the cervical or lumbar spine or extremities ( shoulders , knees , and hips ) in the Evaluation of Stepped Care for Chronic Pain ( ESCAPE ) trial from December @ , @ , through June @ , @ .


The @-month follow-up was completed by April @ .


Patients received treatment at a postdeployment clinic and @ general medicine clinics at a Veterans Affairs medical center .


Step @ included @ weeks of analgesic treatment and optimization according to an algorithm coupled with pain self-management strategies ; step @ , @ weeks of cognitive behavioral therapy .


All intervention aspects were delivered by nurse care managers .


Pain-related disability ( Roland Morris Disability Scale ) , pain interference ( Brief Pain Inventory ) , and pain severity ( Graded Chronic Pain Scale ) .


The primary analysis included @ patients receiving the stepped-care intervention and @ patients receiving usual care .


At @ months , the mean decrease from baseline in the Roland Morris Disability Scale score was @ ( @ % CI , -@ to -@ ) points in the usual care group and @ ( @ % CI , -@ to -@ ) points in the intervention group ( between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- points ; P = @ ) .


The mean decrease from baseline in the Pain Interference subscale score of the Brief Pain Inventory was @ points in the usual care group and @ points in the intervention group ( between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- points ; P = @ ) .


The Graded Chronic Pain Scale severity score was reduced by @ points in the usual care group and @ points in the intervention group ( between-group difference , -@ -LSB- @ % CI , -@ to -@ -RSB- points ; P = @ ) .


A stepped-care intervention that combined analgesics , self-management strategies , and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability , pain interference , and pain severity in veterans with chronic musculoskeletal pain .


Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD .


A phase @ , multicenter , randomized , double blind , placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD .


Starting in April of @ , @ CKD patients ( eGFR = @ ml/min per @ m ( @ ) ) with a serum phosphate@ @ mg/dl were randomized @:@ to ferric citrate hydrate or placebo for @ weeks .


The primary end point was change in serum phosphate from baseline to the end of treatment .


Secondary end points included the percentage of patients achieving target serum phosphate levels ( @-@ @ mg/dl ) and change in fibroblast growth factor-@ at the end of treatment .


The mean change in serum phosphate was -@ mg/dl ( @ % confidence interval , -@ to -@ mg/dl ) in the ferric citrate hydrate group and @ mg/dl ( @ % confidence interval , -@ to @ mg/dl ) in the placebo group ( P < @ for difference between groups ) .


The percentage of patients achieving target serum phosphate levels was @ % in the ferric citrate hydrate group and @ % in the placebo group ( P < @ ) .


Fibroblast growth factor-@ concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo ( change from baseline -LSB- median -RSB- , -@ versus @ pg/ml ; P < @ ) .


Ferric citrate hydrate significantly increased serum iron , ferritin , and transferrin saturation compared with placebo ( P = @ or P < @ ) .


Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo .


Overall , adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo , with gastrointestinal disorders occurring in @ % of ferric citrate hydrate patients and @ % of patients receiving placebo .


In patients with nondialysis-dependent CKD , @-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-@ while simultaneously increasing serum iron parameters .


Duchenne and Becker muscular dystrophies ( DBMD ) are allelic disorders caused by mutations in dystrophin .


Adults with DBMD develop life-threatening cardiomyopathy .


Inhibition of phosphodiesterase @ ( PDE@ ) improves cardiac function in mouse models of DBMD .


To determine whether the PDE@-inhibitor sildenafil benefits human dystrophinopathy , we conducted a randomized , double-blind , placebo-controlled trial ( ClinicalTrials.gov , number NCT@ ) .


Adults with DBMD and cardiomyopathy ( ejection fraction@ % ) were randomized to receive sildenafil ( @mg @ daily ) or placebo for @ months .


All subjects received an additional @ months of open-label sildenafil .


The primary endpoint was change in left ventricular end-systolic volume ( LVESV ) on cardiac magnetic resonance imaging .


Secondary cardiac endpoints , skeletal muscle function , and quality of life were also assessed .


An interim analysis ( performed after @ subjects completed the blinded phase ) revealed that @ % ( @ of @ ) of subjects had a @ % increase in LVESV after @ months of sildenafil compared to @ % ( @ of @ ) of subjects receiving placebo .


Subjects with LVESV > @ml at baseline were more likely to worsen at @ months regardless of treatment assignment ( p = @ ) .


Due to the higher number of subjects worsening on sildenafil , the data and safety monitoring board recommended early termination of the study .


There were no statistically significant differences in outcome measures between treatment arms .


Due to the small sample size , comparisons between groups must be interpreted with caution .


However , this trial suggests that sildenafil is unlikely to improve cardiac function in adults with DBMD .


The aim of the present exploratory clinical study was to evaluate LD as an add-on therapy for treating nightmares .


Thirty-two subjects having nightmares ( ICD-@ : F@ @ ) at least twice a week participated .


Subjects were randomly assigned to group : A ) Gestalt therapy group ( = GTG ) , or B ) Gestalt and lucid dreaming group therapy ( = LDG ) .


Each group lasted ten weeks .


Participants kept a sleep/dream diary over the treatment .


Examinations with respect to nightmare frequency and sleep quality ( Pittsburgh Sleep Quality Index ) were carried out at the beginning , after five and ten weeks and at a follow-up three months later .


Concerning nightmare frequency , a significant reduction was found in both groups after the ten-week-study and at the follow-up ( Wilcoxon test : P @ ) .


Significant reduction in dream recall frequency could only be observed in the GTG ( Wilcoxon test : P @ ) .


For subjects having succeeded in learning lucid dreaming , reduction was sooner and higher .


Sleep quality improved for both groups at the follow-up ( P @ , Wilcoxon test ) .


Only the LDG showed significant improvement at the end of therapy ( P @ ) .


Lucid dreaming , in combination with Gestalt therapy , is a potent technique to reduce nightmare frequency and improve the subjective quality of sleep .


In Serbia , there have been no broad campaigns or educational programs focused on adolescents ' sun protection .


The aim of the study was to assess whether an educational program would have impact on changes of attitudes and sun-protective behaviors of high school students .


More specific aim was to examine whether sex and age differences in sun behavior exists .


Educational program was designed to provoke changes in attitudes towards sun protection and sun behavior .


The investigation was carried out in Belgrade , Serbia in two educational cycles , during spring @ and @ .


Sixteen - and @-year old high schools students were targeted and assessed before and after the educational intervention by means of self-report questionnaire designed for this study ( about skin types and sun behavior ) .


The students ' attitudes towards sun protection and sun behavior before and after the educational intervention were compared and analyzed by the Pearson 's chi-square test and logistic regression analyses .


In the second educational cycle ( @ ) age and gender differences in sun behavior were analyzed .


Overall @ students in @ , and @ students in @ year from @ high schools participated .


A statistically significant behavior change was observed for the use of sunglasses in @ -- the number of students using them increased from @ % to @ % ( p < @ ) .


There were no significant changes in other ways of protection i.e. sunscreen use , protective clothes or staying in shade .


Educational program had an impact , but broader activities involving schools , local communities and media are needed for significant changes in sun behavior and attitude .


There are no treatments available to slow or prevent the progression of Parkinson disease , despite its global prevalence and significant health care burden .


The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies .


To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease .


The Long-term Study @ , a multicenter , double-blind , parallel-group , placebo-controlled , @:@ randomized efficacy trial .


Participants were recruited from @ investigative sites in the United States and Canada and included @ men and women with early ( within @ years of diagnosis ) and treated ( receiving dopaminergic therapy ) Parkinson disease .


Participants were enrolled from March @ to May @ and followed up until September @ .


Participants were randomized to placebo or creatine ( @ g/d ) monohydrate for a minimum of @ years ( maximum follow-up , @ years ) .


The primary outcome measure was a difference in clinical decline from baseline to @-year follow-up , compared between the @ treatment groups using a global statistical test .


Clinical status was defined by @ outcome measures : Modified Rankin Scale , Symbol Digit Modalities Test , PDQ-@ Summary Index , Schwab and England Activities of Daily Living scale , and ambulatory capacity .


All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test .


Higher summed ranks ( range , @-@ ) indicate worse outcomes .


The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least @ years prior to the date of the analysis ( n = @ ) .


The median follow-up time was @ years .


Of the @ participants , the mean of the summed ranks for placebo was @ ( @ % CI , @-@ ) and for creatine was @ ( @ % CI , @-@ ) .


The global statistical test yielded t@ @ = -@ ( @-sided P = @ ) .


There were no detectable differences ( P < @ to partially adjust for multiple comparisons ) in adverse and serious adverse events by body system .


Among patients with early and treated Parkinson disease , treatment with creatine monohydrate for at least @ years , compared with placebo did not improve clinical outcomes .


These findings do not support the use of creatine monohydrate in patients with Parkinson disease .


There is a dual need for ( @ ) innovative theory-based smartphone applications for smoking cessation and ( @ ) controlled trials to evaluate their efficacy .


Accordingly , this study tested the feasibility , acceptability , preliminary efficacy , and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy ( ACT ) application for smoking cessation vs. an application following US Clinical Practice Guidelines .


Adult participants were recruited nationally into the double-blind randomized controlled pilot trial ( n = @ ) that compared smartphone-delivered ACT for smoking cessation application ( SmartQuit ) with the National Cancer Institute 's application for smoking cessation ( QuitGuide ) .


We recruited @ participants in two months .


SmartQuit participants opened their application an average of @ times , as compared to @ times for QuitGuide participants ( p < @ ) .


The overall quit rates were @ % in SmartQuit vs. @ % in QuitGuide ( OR = @ ; @ % CI = @-@ @ ) .


Consistent with ACT 's theory of change , among those scoring low ( below the median ) on acceptance of cravings at baseline ( n = @ ) , the quit rates were @ % in SmartQuit vs. @ % in QuitGuide ( OR = @ ; @ % CI = @-@ @ ) .


ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines .


As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .


The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) showed that early intervention with cardiac-resynchronization therapy with a defibrillator ( CRT-D ) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of @ years , as compared with defibrillator therapy alone .


We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population .


Post-trial follow-up over a median period of @ years was assessed among all @ surviving patients ( phase @ ) and subsequently among @ patients who were enrolled in post-trial registries ( phase @ ) .


All reported analyses were performed on an intention-to-treat basis .


At @ years of follow-up after initial enrollment , the cumulative rate of death from any cause among patients with left bundle-branch block was @ % among patients randomly assigned to CRT-D , as compared with @ % among those randomly assigned to defibrillator therapy alone ( adjusted hazard ratio in the CRT-D group , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex , cause of cardiomyopathy , or QRS duration .


In contrast , CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block ( adjusted hazard ratio for death from any cause , @ ; @ % CI , @ to @ ; P = @ ; P < @ for interaction of treatment with QRS morphologic findings ) .


Our findings indicate that in patients with mild heart-failure symptoms , left ventricular dysfunction , and left bundle-branch block , early intervention with CRT-D was associated with a significant long-term survival benefit .


( Funded by Boston Scientific ; ClinicalTrials.gov numbers , NCT@ , NCT@ , and NCT@ . )


Mass drug administration ( MDA ) is part of the SAFE strategy for trachoma elimination .


This study examined the effect of three annual MDAs on prevalence of trachoma among @ longitudinal cohorts of Tanzanian children .


Children younger than @ years were assigned to cohorts based on age at baseline and followed annually for @ years , with newborns assigned to new cohorts over time .


Annual MDA consisted of topical tetracycline for children younger than @ months and oral azithromycin for those @ months and older .


Follicular trachoma ( TF ) and Chlamydia trachomatis infection status were assessed annually before the next MDA .


Prevalence and risk factors for TF and infection at each age were compared across cohorts .


At each survey , most age groups and cohorts had MDA coverage of more than @ % and showed decreased TF prevalence after every MDA .


One cohort had consistently lower coverage , higher-than-expected TF and infection at ages @ and @ , and elevated risk of TF at age @ relative to the preceding cohort in spite of receiving one additional MDA ( odds ratio @ , @ % confidence interval @-@ @ ) .


Cohorts aged @ or older at baseline generally showed reductions in TF and infection after each MDA , whereas younger cohorts showed decreased infection but increased TF over time .


Successive cohorts of never-treated children younger than @ year showed sequential TF and infection reductions with each MDA ( P < @ ) .


Multiple MDAs significantly reduce trachoma prevalence and appear to increasingly protect children born into these communities .


The youngest children show declining/stable rates of infection but increasing rates of trachoma , which may reflect longer duration of clinical signs .


Tamoxifen , a synthetic nonsteroidal anti-estrogen known to modulate the production of transforming growth factor-beta ( TGF - ) , has demonstrated effectiveness on fibroblast activity in vitro and in vivo .


The main purpose of this study was to investigate the effect of tamoxifen on the outcome of surgery for Dupuytren contractures in patients with a strong predisposition toward fibrosis .


We used a prospective , randomized , double-blind study protocol ( conforming to the CONSORT standards ) to investigate the influence of tamoxifen compared with placebo on the total passive extension deficit in the finger and patient satisfaction after subtotal fasciectomy in thirty patients with a strong predisposition toward fibrosis ( grade , > @ according to the Abe scale ) .


High-dosage tamoxifen ( @ mg/day ) was administered from six weeks prior until twelve weeks after surgery , and patients were monitored for two years .


Three months after surgery , patients in the tamoxifen group had a smaller total passive extension deficit and higher satisfaction compared with the placebo group .


This positive effect was lost over the two years following cessation of the medication .


This study demonstrated that the short-term outcome of Dupuytren disease treatment could be influenced by use of tamoxifen as a neoadjuvant from six weeks prior to three months after subtotal fasciectomy in patients with a strong predisposition toward fibrosis .


However , the beneficial effect disappeared within two years after surgery , with worsening of the contractures after the medication was discontinued .


Thus , tamoxifen may have a short-term effect on the outcome of surgery for Dupuytren disease .


Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality .


Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .


We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .


The Steroids In caRdiac Surgery ( SIRS ) study is a double-blind , randomised , controlled trial .


We used a central computerised phone or interactive web system to randomly assign ( @:@ ) patients at high risk of morbidity and mortality from @ hospital or cardiac surgery centres in @ countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone ( @ mg at anaesthetic induction and @ mg at initiation of cardiopulmonary bypass ) or placebo .


Patients were assigned with block randomisation with random block sizes of @ , @ , or @ and stratified by centre .


Patients aged @ years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least @ .


Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding @ days .


Patients , caregivers , and those assessing outcomes were masked to allocation .


The primary outcomes were @-day mortality and a composite of death and major morbidity ( ie , myocardial injury , stroke , renal failure , or respiratory failure ) within @ days , both analysed by intention to treat .


Safety outcomes were also analysed by intention to treat .


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


Patients were recruited between June @ , @ , and Dec @ , @ .


Complete @-day data was available for all @ patients randomly assigned to methylprednisolone ( n = @ ) and to placebo ( n = @ ) .


Methylprednisolone , compared with placebo , did not reduce the risk of death at @ days ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- patients ; relative risk -LSB- RR -RSB- @ , @ % CI @-@ , p = @ ) or the risk of death or major morbidity ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; RR @ , @ % CI @-@ , p = @ ) .


The most common safety outcomes in the methylprednisolone and placebo group were infection ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , surgical site infection ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and delirium ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass .


The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass .


Previous studies have reported the cardioprotective effect of dexmedetomidine and lidocaine .


We compared the effect of lidocaine and dexmedetomidine infusion during off-pump coronary artery bypass graft ( OPCAB ) .


@ patients undergoing OPCAB were enrolled .


The lidocaine group ( n = @ , Group LIDO ) received an infusion of lidocaine @ mg/kg/h after bolus @ mg/kg ; the dexmedetomidine group ( n = @ , Group DEX ) received dexmedetomidine @-@ @ g/kg/h ; the combined group ( n = @ , Group Combined ) received infusion of both drugs ; and the control group ( n = @ ) received nothing .


We measured serum creatinine kinase-myocardial band ( CK-MB ) and cardiac troponin I ( cTnI ) concentration before and immediately after the surgery , postoperative day ( POD ) # @ and # @ .


The complication rate and clinical outcomes were compared .


The concentration of cTnI was significantly lower in the Group LIDO and Group Combined than the control group on POD # @ .


The concentration of CK-MB was significantly lower in the Group LIDO and Group Combined compared to the control group on POD # @ and # @ -LSB- CK-MB on POD # @ : @ ( @-@ @ ) vs. @ ( @-@ @ ) vs. @ ( @-@ @ ) in the Group LIDO , combined and control , respectively , Group LIDO vs. control : p = @ , Group Combined vs. control : p = @ -RSB- .


The AUC of CK-MB was significantly lower in the Group LIDO and Group Combined than the control group .


However , clinical variables including complication rate , ICU stay and one-year mortality were not different .


Lidocaine infused at @ mg/kg/h , but not dexmedetomidine infused at @-@ @ g/kg/h reduced postoperative myocardial injury marker levels compared with the control group .


However , no other clinical benefits were observed .


To compare estimates by bioimpedance spectroscopy analysis ( BIS ) of extracellular water ( ECW ) , fat mass ( FM ) , and fat-free mass ( FFM ) against standard techniques of bromide dilution and dual energy X-ray absorptiometry ( DXA ) during intervention that causes significant changes in water compartments and body composition .


Body composition analysis using BIS , bromide dilution , and DXA was performed in @ healthy recreational athletes ( @ men , @ women ; aged @-@ years ; BMI @ @ kg/m ( @ ) ) who participated in a double-blinded , randomized , placebo-controlled study of GH and testosterone treatment .


The comparison of BIS with bromide dilution and DXA was analyzed using linear regression and the Bland-Altman method .


At baseline , there was a significant correlation between BIS and bromide dilution-derived estimates for ECW , and DXA for FM and FFM ( P < @ ) .


ECW by BIS was @ @ % lower compared with bromide dilution , while FM was @ @ % lower and FFM @ @ % higher compared with DXA ( P < @ ) .


During treatment , the change in ECW was similar between BIS and bromide dilution , whereas BIS gave a significantly greater reduction in FM ( @ @ % ) and a greater increase in FFM ( @ @ % ) compared with DXA ( P < @ ) .


Significant differences in body composition estimates between the BIS and DXA were observed only in men , particularly during the treatment that caused greatest change in water compartments and body composition .


In healthy adults , bioimpedance spectroscopy is an acceptable tool for measuring ECW ; however , BIS overestimates FFM and substantially underestimates FM compared with DXA .


Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders .


The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed .


To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate .


Multisite , double-blind , randomized clinical trial conducted from March @ to July @ at @ US clinical research sites .


Randomized patients ( n = @ ) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic .


Intramuscular injections of haloperidol decanoate @ to @ mg or paliperidone palmitate @ to @ mg every month for as long as @ months .


Efficacy failure , defined as a psychiatric hospitalization , a need for crisis stabilization , a substantial increase in frequency of outpatient visits , a clinician 's decision that oral antipsychotic could not be discontinued within @ weeks after starting the long-acting injectable antipsychotics , or a clinician 's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit .


Key secondary outcomes were common adverse effects of antipsychotic medications .


There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate ( adjusted hazard ratio , @ ; @ % CI , @-@ @ ) .


The number of participants who experienced efficacy failure was @ ( @ % ) in the paliperidone palmitate group and @ ( @ % ) in the haloperidol decanoate group .


On average , participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight ; after @ months , the least-squares mean weight change for those taking paliperidone palmitate was increased by @ kg ( @ % CI , @-@ @ ) and was decreased for those taking haloperidol decanoate ( -@ kg ; @ % CI , -@ to -@ ) .


Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin ( men , @ g/L -LSB- @ % CI , @-@ @ -RSB- vs @ g/L -LSB- @ % CI , @-@ @ -RSB- ; P < @ , and for women , @ -LSB- @ % CI , @-@ @ -RSB- vs @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia ( @ -LSB- @ % CI , @-@ @ -RSB- vs @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


In adults with schizophrenia or schizoaffective disorder , use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure , but was associated with more weight gain and greater increases in serum prolactin , whereas haloperidol decanoate was associated with more akathisia .


However , the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate .


To investigate whether short-term systemic effects of wood smoke occurred in atopic subjects after experimental wood smoke exposures .


A double-blind climate chamber study was conducted on @ healthy atopic subjects with exposures to filtered air and wood smoke .


Pneumoproteins , coagulation and adhesion factors , and cytokines were measured .


Heart rate was monitored with pulse monitors .


Data were analyzed with mixed models .


Few differences in the outcomes were observed .


Plasma tissue factor remained elevated during filtered air exposure ( P = @ ) .


P-selectin declined independent of exposure ( P = @ ) .


Interleukin-@ increased after filtered air ( P = @ ) .


The study confirmed previous observations among nonatopics of limited changes after a @-hour wood smoke exposure .


It has been suggested that weight reduction decreases the frequency of urinary incontinence ( UI ) episodes .


However , it is not known if this improvement is associated with anatomical changes in the pelvis .


The aim of this study was to investigate the effects of weight loss on UI episodes and pelvic floor anatomy .


Three hundred seventy-eight overweight/obese women were randomly allocated either to behavioral weight loss or to structured education programs .


The patients were evaluated by voiding diary , Pelvic Floor Distress Inventory ( PFDI ) , and Pelvic Organ Prolapse Quantification ( POP-Q ) system at baseline and after @months .


The women in the intervention group had a mean weight loss of @ % , whereas the weight in the control group remained almost the same ( P < @ ) .


While there were no change in stress and urge incontinence episodes in the control group , the mean number of stress incontinence episodes per @-day diary dropped from @ episodes to @ , and the mean number of urge incontinence episodes per @-day diary dropped from @ episodes to @ in the study group ( P < @ ) .


Regarding the POP-Q system , only genital hiatus , perineal body , and Ap measurements were significantly lower in the weight loss group than in the control group after @months .


Weight reduction provides improvement in episodes of UI , decreases the incidence of drops of urine leakage , and increases quality of life related to pelvic floor symptoms .


However , there are little to no changes in the parameters of the POP-Q system with weight reduction .


Single-day , high-dose systemic antiviral drugs are effective in the treatment of labial herpes ( herpes labialis -LSB- HL -RSB- ) .


Aciclovir Lauriad mucoadhesive buccal tablet ( ABT ) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in the oral cavity , supporting its evaluation as a single low dose in HL .


In this multicenter double-blind placebo-controlled patient-initiated trial , @ patients with recurrent HL were randomly assigned to either a single application of ABT @ mg or a matching placebo as soon as prodromal symptoms occurred .


The primary endpoint was the time to healing ( TTH ) of primary vesicular lesion ( modified intention-to-treat population ) .


Other endpoints included incidence of blocked episodes , duration of herpes episodes , and incidence and time to next recurrence evaluated during a @-month follow-up period ( intention-to-treat population ) .


With ABT @ mg , median TTH of primary vesicular lesion was reduced ( @ days vs @ days , P = @ ) , the incidence of blocked herpes episodes was increased by @ % ( @ % vs @ % ; P = @ ) , and the median duration of herpes episodes was reduced ( @ days vs @ days , P = @ ) .


During the @-month follow-up period , recurrence of herpes lesions was less frequent ( @ % vs @ % ; P = @ ) and delayed ( @ days vs @ days , P = @ ) in the ABT @ mg .


Both treatments were safe .


A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence .


There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease .


There are no studies from low - to middle income countries ( LMICs ) evaluating trained community health worker ( CHW ) - based interventions for the secondary prevention of coronary heart disease .


We designed a hospital-based , open randomized trial of CHW-based interventions versus standard care .


Patients after an acute coronary syndrome ( ACS ) were randomized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to standard care for @ months during which study outcomes were recorded .


The CHWs were trained over a period of @ months .


The primary outcome measure was medication adherence .


The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure -LSB- BP -RSB- , body weight , body mass index -LSB- BMI -RSB- , heart rate , lipids ) , and major adverse cardiovascular events .


We recruited @ patients stabilized after an ACS from @ hospitals in @ Indian cities .


The mean age was @ ( @ ) years , and @ % were females .


A high prevalence of risk factors such as hypertension ( @ % ) , diabetes ( @ % ) , tobacco consumption ( @ % ) , and inadequate physical activity ( @ % ) was documented .


A little over half had ST-elevation myocardial infarction ( @ % ) , and @ % had non-ST-elevation myocardial infarction or unstable angina .


The CHW interventions and training for SPREAD have been developed and adapted for local use .


The results and experience of this study will be important to counter the burden of cardiovascular diseases in low - to middle income countries .


We assessed safety and efficacy of two selective @-HSD@ inhibitors ( RO@/RO -@ and RO@/RO -@ ) in this randomized , controlled study in metformin-treated patients with type @ diabetes .


Patients either received placebo ( N = @ ) , RO-@ BID @ mg ( N = @ ) or @ mg ( N = @ ) or RO-@ QD @ mg ( N = @ ) or @ mg ( N = @ ) for @ days .


Metabolic assessments comprising of nine-point plasma glucose profiles , oral glucose tolerance tests and determination of metabolic biomarkers including insulin , C-peptide , glucagon , HbA@c and lipids were done at baseline and end of treatment .


Despite the short treatment duration , both RO-@ and RO-@ showed trends for improved HbA@c and consistent reductions in body weight ( -@ to -@ kg ) exceeding those observed with placebo ( -@ kg , p = @ for @ mg RO-@ vs. placebo ) .


Insulin sensitivity parameters ( e.g. HOMA-IR and Matsuda-Index ) improved non-significantly with @ mg RO-@ .


Lipid parameters did not consistently improve with either compound , but RO-@ led to non-significant increases in triglycerides and VLDL-cholesterol versus placebo .


Both compounds were well tolerated and showed inhibitory effects on @-HSD@ activity based on urinary corticosteroid excretion .


As reported for other @-HSD@-inhibitors increased concentrations of ACTH and adrenal androgen precursors were found with RO-@ , but not with RO-@ .


Slight metabolic improvements were seen , in particular with RO-@ high dose , however , the observed changes often did not reach statistical significance and were not clearly dose dependent .


Studies of longer duration are needed to further investigate potential benefits and risks of these compounds .


To evaluate the effect of wearing a dorsiflexion assist orthosis ( DAO ) on walking distance , physiological cost , fatigue , and strength and balance measures after a modified @-minute walk test ( @MWT ) in people with multiple sclerosis ( MS ) .


Randomized crossover trial .


Hospital Movement Laboratory .


People with moderate MS and Expanded Disability Status Scale score of @ ( N = @ ; @ women ) .


Modified @MWT with and without a DAO worn on the weaker leg .


Distance walked , perceived fatigue , and the physiological cost of walking were compared between walking conditions .


Pre - and postwalk changes in knee extensor and ankle dorsiflexor isometric strength and standing postural sway with eyes open and closed were compared between walking conditions .


There were no differences in distance walked or perceived fatigue between the @ walking conditions .


However , there was a reduced physiological cost of walking ( P < @ ) , a smaller reduction in knee extensor strength ( P < @ ) , and a smaller increase in standing postural sway with eyes open ( P < @ ) after walking while wearing the DAO compared with walking without wearing the DAO .


Despite not increasing walking distance or reducing perceived fatigue , the DAO reduced the physiological cost of walking and maintained knee strength and standing balance , which may have important implications for physical rehabilitation in people with MS. Further trials are required to determine whether the beneficial effects of wearing a DAO found here are maintained for longer periods .


Menu labels displaying food energy in physical activity calorie equivalents ( PACE ) is a possible strategy to encourage ordering meals with fewer calories and promoting physical activity .


Potential effects of such labeling for children have never been examined .


We conducted a national survey of @ parents randomized to @ of @ fast food menus : no labels , calories only , calories plus minutes , or calories plus miles needed to walk to burn the calories .


Respondents were asked to imagine they were in a fast food restaurant and place an order for their child .


At the survey 's conclusion , all respondents were shown a calorie-only label and both PACE labels and asked to rate the likelihood each label would influence them to encourage their child to exercise .


We excluded respondents whose meals totaled @ calories or > @ calories , leaving @ parents in the analysis .


The mean age of the child for whom the meal was `` ordered '' was @ years .


Parents whose menus displayed no label ordered an average of @ calories , whereas those shown calories only , calories plus minutes , or calories plus miles ordered @ , @ , and @ calories , respectively ( P = @ ) .


Only @ % of parents reported that calories-only labeling would be `` very likely '' to prompt them to encourage their children to exercise versus @ % for calories plus minutes ( P < @ ) and @ % for calories plus miles ( P < @ ) .


PACE labeling may influence parents ' decisions on what fast food items to order for their children and encourage them to get their children to exercise .


Recurrent laryngeal nerve palsy ( RLNP ) and hypoparathyroidism are complications of thyroid surgery .


The convalescence can depend on several factors ( ie , pain , fatigue , nausea , and vomiting ) .


Supplemental oxygen improves inflammatory and immune function and decreases nausea and vomiting after surgical procedures .


We have investigated whether supplemental perioperative oxygen administration could improve surgical outcomes in patients undergoing thyroid surgery .


Three hundred and sixty patients were randomized to an oxygen/air mixture with a fraction of inspired oxygen ( FiO@ ) of @ % ( n = @ ) or @ % ( n = @ ) .


Administration was commenced after induction of anesthesia and maintained for @ hours after surgery .


The primary end points were temporary or permanent RLNP and transient or definitive hypoparathyroidism .


Pain and fatigue scores , nausea , and the number of vomiting episodes were also registered .


Preoperatively and at several times during the first @ postoperative hours , we measured C-reactive protein , interleukin ( IL ) -@ , and IL@ levels .


In the @ % FiO@ group , the rate of temporary RLNP ( @ % ) was significantly lower compared with the @ % FiO@ group ( @ % ) ( p = @ ) .


In addition , postoperative transient biochemical hypoparathyroidism occurred more frequently in the @ % FiO@ group ( @ % ) than in the @ % FiO@ group ( @ % ) ( p = @ ) .


Supplemental @ % FiO@ significantly reduced postoperative levels of C-reactive protein ( p < @ ) , IL@ and IL@ ( p < @ ) , fatigue ( p < @ ) , and overall pain during the first @ postoperative hours ( p < @ ) .


Supplemental @ % FiO@ also reduced nausea and vomiting on the day of operation ( p = @ ) .


Supplemental @ % FiO@ reduced postoperative temporary RLNP and hypoparathyroidism rates and reduced pain , fatigue , nausea , and vomiting after thyroid surgery .


Treatment of patients with multimorbidity is challenging .


A rational reduction of long-term drugs can lead to decreased mortality , less acute hospital treatment , and a reduction of costs .


Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence .


The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients .


The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based , patient-centered medication review prior to the patient 's discharge from hospital .


The POLITE-RCT trial is a cluster randomized controlled trial .


Two major secondary health care providers of Mecklenburg-Western Pomerania , Germany , take part in the study .


Clusters are wards of both medical centers .


All wards where patients with chronic diseases and multimorbidity are regularly treated will be included .


Patients aged @ + years who take five or more prescribed long-term drugs and who are likely to spend at least @ days in the participating hospitals will be recruited and included consecutively .


Cluster-randomization takes place after a six-month baseline data collection period .


Patients of the control group receive care as usual .


The independent two main primary outcomes are ( @ ) health-related quality of life ( EQ-@D ) and ( @ ) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group .


The secondary outcomes are appropriateness of prescribed medication ( PRISCUS list , Beers Criteria , MAI ) , patient satisfaction ( TSQM ) , patient empowerment ( PEF-FB-@ ) , patient autonomy ( IADL ) , falls , re-hospitalization , and death .


The points of measurement are at admission to ( T@ ) and discharge from hospital ( T@ ) as well as @ and @ months after discharge from the hospital ( T@ and T@ ) .


In @ wards , @,@ patients will be recruited .


In case of positive evaluation , the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy .


AST@ is an orally active irreversible small molecule inhibitor of EGFR ( erbB@ ) , HER@ ( erbB@ ) and HER@ ( erbB@ ) signaling .


This is a phase I , open-label , dose-escalation study to evaluate the safety and tolerability , pharmacokinetics ( PK ) , and preliminary anti-tumor effects of oral AST@ .


In addition the effects of food on PK was tested .


A modified Fibonacci @ plus @ dose-escalation design was employed to determine the dose-limiting toxicity ( DLT ) and recommended phase II dose ( RP@D ) in patients with advanced solid tumors .


The following dose levels were investigated : once daily ( QD ) at two dose levels ( @-and @ mg ) , twice daily ( BID ) in five dose levels ( @ - , @ - , @ - , @ - and @ mg ) , and three times daily ( TID ) in three dose levels ( @ - , @ - and @ mg ) .


In the PK and extension study , at least eight patients per dose cohort in three dose levels ( maximum tolerated dose -LSB- MTD -RSB- , one or two doses level lower than the MTD ) were enrolled to evaluate the PK profiles .


Seventy-one patients were enrolled , with breast ( n = @ ) and lung cancers ( n = @ ) being the most common primary cancers .


The most frequent drug-related adverse events were grade @ to @ diarrhea and rash , grade @ to @ fatigue .


During dose escalation , the key DLT was grade @ diarrhea observed in @ patients at @ mg BID ( n = @ ) , @ mg BID ( n = @ ) , @ mg TID ( n = @ ) and @ mg TID ( n = @ ) .


AST@ was rapidly absorbed and had moderate to high clearance .


PK concentration parameters increased with dose over the range evaluated , with no evidence of accumulation over time .


Under fed conditions , the mean T ( max ) was prolonged , C ( max ) was increased , and AUC ( @ - ) was raised .


Of the @ evaluable patients , @ patients experienced partial responses , including @ with breast cancer , @ with lung cancer , and @ with gastric cancer .


The best response with stable disease for@ months was achieved in @ patients .


Based on the DLT and PK profile , the RP@D was defined as @ mg TID with evidence of preliminary anti-tumor activity .


Further studies are recommended .


This study aimed to assess the efficacy and safety of flibanserin , a serotonin receptor @A agonist/serotonin receptor @A antagonist , in postmenopausal women with hypoactive sexual desire disorder ( HSDD ) .


Naturally postmenopausal women with HSDD received flibanserin @ mg once daily at bedtime ( n = @ ) or placebo ( n = @ ) for @ weeks .


Co-primary endpoints were changes from baseline to week @ in the number of satisfying sexual events ( SSEs ) across @ days and in the Female Sexual Function Index ( FSFI ) desire domain score .


Secondary endpoints included change from baseline in Female Sexual Distress Scale-Revised ( FSDS-R ) Item @ score ( which assesses distress due to low sexual desire ) , FSDS-R total score , and FSFI total score .


The Patient Benefit Evaluation was asked on treatment discontinuation .