HiSCR was significantly correlated with improvements in all physician-rated and PRO measures ( Spearman 's rho between -@ and -@ , all P < @ ) .


Improvements of all PROs in HiSCR achievers exceeded the respective meaningful improvement thresholds .


In patients with HS with @ ANs , HiSCR achievers had significant improvements in physician-rated and patient-reported HS disease severity and impact .


HiSCR is a valid and meaningful endpoint for assessing HS treatment effectiveness in controlling inflammatory manifestations in this population .


To assess the efficacy of yoga for motor function , mental health , and quality of life outcomes in persons with chronic poststroke hemiparesis .


Twenty-two individuals participated in a randomized controlled trial involving assessment of task-orientated function , balance , mobility , depression , anxiety , and quality of life domains before and after either a @-week yoga intervention ( n = @ ) or no treatment ( n = @ ) .


The yoga intervention did not result in any significant improvements in objective motor function measures , however there was a significant improvement in quality of life associated with perceived motor function ( P = @ ) and improvements in perceived recovery approached significance ( P = @ ) .


Memory-related quality of life scores significantly improved after yoga intervention ( P = @ ) , and those participating in the intervention exhibited clinically relevant decreases in state and trait anxiety .


Preliminary results offer promise for yoga as an intervention to address mental health and quality of life in persons with stroke-related activity limitations .


There is a need to more rigorously evaluate these yoga benefits with a larger randomized controlled trial , which , based on this preliminary trial , is feasible .


Ischemic mitral regurgitation ( IMR ) results from mitral leaflet tethering from left ventricular remodeling .


Heterogeneity in local or global left ventricular remodeling can result in differential tethering patterns and affect mitral valve function and the degree of mitral regurgitation .


The aims of this study were to compare mitral valve geometry in asymmetric and symmetric tethering patterns using three-dimensional transesophageal echocardiography and to examine the impact of tethering pattern on IMR severity .


Sixty-two patients with moderate or greater IMR underwent three-dimensional transesophageal echocardiography for the assessment of mitral valve geometry .


Symmetric and asymmetric tethering patterns were determined by mitral regurgitation jet direction and coaptation of the mitral leaflets .


The ratio of posterior to anterior leaflet tethering angle was a measure of tethering pattern ( the higher the ratio , the more asymmetric the pattern ) .


Overall tethering degree was assessed by tenting volume ( TV ) .


Compared with the symmetric group , the asymmetric group had less annular dilatation , greater annular heights ( @ @ vs @ @ mm , P < @ ) , greater ratios of posterior to anterior leaflet tethering angle ( @ @ vs @ @ , P < @ ) , and smaller TVs with more posterior displacement of the coaptation line .


Vena contracta normalized to TV was greater in the asymmetric group ( @ @ vs @ @ cm/mL , P < @ ) .


Multivariate analysis showed that both ratio of posterior to anterior leaflet tethering angle ( = @ , P < @ ) and TV ( = @ , P = @ ) were predictors of IMR severity .


Differences in mitral valve geometry are observed between asymmetric and symmetric tethering patterns in IMR .


IMR degree is affected by both the pattern of tethering and the total degree of tethering .


For the same degree of tethering , an asymmetric pattern is associated with increased MR severity .


The pattern of mitral leaflet tethering may be considered in therapeutic decision making .


Delirium is associated with substantial morbidity and mortality rates in elderly hospitalised patients , and a growing problem due to increase in life expectancy .


Implementation of standardised non-pharmacological delirium prevention strategies is challenging and adherence remains low .


Pharmacological delirium prevention with haloperidol , currently the drug of choice for delirium , seems promising .


However , the generalisability of randomised controlled trial results is questionable since studies have only been performed in selected postoperative hip-surgery and intensive care unit patient populations .


We therefore present the design of the multicenter , randomised , double-blind , placebo-controlled clinical trial on early pharmacological intervention to prevent delirium : haloperidol prophylaxis in older emergency department patients ( The HARPOON study ) .


In six Dutch hospitals , at-risk patients aged @ years or older acutely admitted through the emergency department for general medicine and surgical specialties are randomised ( n = @ ) for treatment with prophylactic haloperidol @ mg or placebo twice daily for a maximum of seven consecutive days .


Primary outcome measure is the incidence of in-hospital delirium within seven days of start of the study intervention , diagnosed with the Confusion Assessment Method , and the Diagnostic and Statistical Manual of Mental Disorders , fourth edition criteria for delirium .


Secondary outcome measures include delirium severity and duration assessed with the Delirium Rating Scale Revised @ ; number of delirium-free days ; adverse events ; hospital length-of-stay ; all-cause mortality ; new institutionalisation ; ( Instrumental ) Activities of Daily Living assessed with the Katz Index of ADL , and Lawton IADL scale ; cognitive function assessed with the Six-item Cognitive Impairment Test , and the Dutch short form Informant Questionnaire on Cognitive Decline in the Elderly .


Patients will be contacted by telephone three and six months post-discharge to collect data on cognitive - and physical function , home residency , all-cause hospital admissions , and all-cause mortality .


The HARPOON study will provide relevant information on the efficacy and safety of prophylactic haloperidol treatment for in-hospital delirium and its effects on relevant clinical outcomes in elderly at-risk medical and surgical patients .


This study was designed to compare the performances of @ airway devices in achieving successful ventilation .


A randomized crossover trial was conducted to evaluate @ airway devices : laryngeal mask airway ( LMA ) , i-gel ( iGEL ) , PENTAX Airway Scope ( AWS ) , and Macintosh laryngoscope ( MCL ) .


Thirty-eight unskilled rescuers performed intubation on a manikin during chest compressions in normal and difficult airway scenarios .


The time to ventilation , intubation success rate , and difficulty of intubation were measured .


The time to ventilation of the airway devices in the normal scenario had a median value of @ seconds ( interquartile range , @-@ @ seconds ) for iGEL , @ seconds ( @-@ @ seconds ) for LMA , @ seconds ( @-@ @ seconds ) for AWS , and @ seconds ( @-@ @ seconds ) for MCL .


In the difficult airway scenario , the respective time to ventilation was @ seconds ( @-@ @ seconds ) , @ seconds ( @-@ @ seconds ) , @ seconds ( @-@ @ seconds ) and @ seconds ( @-@ @ seconds ) .


The success rates were @ % and @ % for LMA , @ % and @ % for iGEL , @ % and @ % for AWS , and @ % and @ % for MCL in the normal and difficult airway scenarios .


The difficulties of intubation expressed as numerical rating scale were @ and @ ( median values ) for LMA , @ and @ for iGEL , @ and @ for AWS , and @ and @ for MCL in the normal and difficult airway scenarios , respectively .


With novice intubators who were unfamiliar with the airway devices , the LMA , iGEL , and AWS were superior to the MCL for establishing an airway without interruption of chest compressions in a manikin study .


Intubation with the iGEL was faster and easier than with the other airway devices .


Myeloablative allogeneic haematopoietic stem cell transplantation ( allo-HSCT ) is a major procedure usually accompanied by multifactorial malnutrition , prompting the recommendation of systematic artificial nutritional support .


Parenteral nutrition ( PN ) is usually administered during allo-HSCT , essentially for practical reasons .


Recently published data suggest that enteral nutrition ( EN ) , given as systematic artificial nutrition support , could decrease grade III-IV graft-versus-host disease ( GVHD ) and infectious events , which are associated with early toxicity after allo-HSCT and then have an impact on early transplant-related mortality ( D@ mortality ) .


We report on the NEPHA trial : an open-label , prospective , randomised , multi-centre study on two parallel groups , which has been designed to evaluate the effect of EN compared to PN on early toxicity after an allo-HSCT procedure .


Two hundred forty patients treated with allo-HSCT for a haematological malignancy will be randomly assigned to two groups to receive either EN or PN .


The primary endpoint will assess the effect of EN on D@ mortality .


Secondary endpoints will compare EN and PN with regards to the main haematological , infectious and nutritional outcomes .


The impacts of nutritional support should exceed the limits of nutritional status improvement : EN may directly reduce immunological and infectious events , as well as decrease early transplant-related morbidity and mortality .


EN and PN need to be prospectively compared in order to assess their impacts and to provide treatment guidelines .


( Clinical trials gov number : NCT@ ; registration : July @th , @ ) .


Butter is known to have a cholesterol-raising effect and , therefore , has often been included as a negative control in dietary studies , whereas the effect of moderate butter intake has not been elucidated to our knowledge .


We compared the effects of moderate butter intake , moderate olive oil intake , and a habitual diet on blood lipids , high-sensitivity C-reactive protein ( hsCRP ) , glucose , and insulin .


The study was a controlled , double-blinded , randomized @ @-wk crossover dietary intervention study with a @-d run-in period during which subjects consumed their habitual diets .


The study included @ healthy men and women ( mean SD total cholesterol : @ @ mmol/L ) who substituted a part of their habitual diets with @ % of energy from butter or refined olive oil .


Study subjects were @ % women with a mean age and body mass index ( in kg/m ) of @ y and @ , respectively .


Butter intake increased total cholesterol and LDL cholesterol more than did olive oil intake ( P < @ ) and the run-in period ( P < @ and P < @ , respectively ) and increased HDL cholesterol compared with the run-in period ( P < @ ) .


No difference in effects was observed for triacylglycerol , hsCRP , insulin , and glucose concentrations .


The intake of saturated fatty acids was significantly higher in the butter period than in the olive oil and run-in periods ( P < @ ) .


Moderate intake of butter resulted in increases in total cholesterol and LDL cholesterol compared with the effects of olive oil intake and a habitual diet ( run-in period ) .


Furthermore , moderate butter intake was also followed by an increase in HDL cholesterol compared with the habitual diet .


We conclude that hypercholesterolemic people should keep their consumption of butter to a minimum , whereas moderate butter intake may be considered part of the diet in the normocholesterolemic population .


Myofascial trigger points ( MTrPs ) are focal disruptions in the skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type HA ( TTH ) .


The present study applied massage focused on MTrPs of patients with TTH in a placebo-controlled , clinical trial to assess efficacy on reducing headache ( HA ) pain .


Fifty-six patients with TTH were randomized to receive @ massage or placebo ( detuned ultrasound ) sessions over @ weeks , or to wait-list .


Trigger point release massage focused on MTrPs in cervical musculature .


HA pain ( frequency , intensity , and duration ) was recorded in a daily HA diary .


Additional outcome measures included self-report of perceived clinical change in HA pain and pressure-pain threshold at MTrPs in the upper trapezius and suboccipital muscles .


From diary recordings , group differences across time were detected in HA frequency ( P = @ ) , but not for intensity or duration .


Post hoc analysis indicated that HA frequency decreased from baseline for both massage ( P < @ ) and placebo ( P = @ ) , but no difference was detected between massage and placebo .


Patient report of perceived clinical change was greater reduction in HA pain for massage than placebo or wait-list groups ( P = @ ) .


Pressure-pain threshold improved in all muscles tested for massage only ( all P 's < @ ) .


Two findings from this study are apparent : ( @ ) MTrPs are important components in the treatment of TTH , and ( @ ) TTH , like other chronic conditions , is responsive to placebo .


Clinical trials on HA that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention .


To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type @ diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone .


The study included @ diabetes mellitus patients presenting erectile dysfunction for at least @ months and dissatisfied with the use of @ mg sildenafil monotherapy .


The patients were randomized in two groups .


Those in group A ( n = @ ) were instructed to use a vacuum erection device only , whereas those in group B ( n = @ ) were treated with combination therapy , including sildenafil @ mg and a vacuum erection device .


Erectile function was evaluated subjectively using the International Index of Erectile Function , Sexual Encounter Profile questionnaire questions @ and @ at visit @ ( baseline ; study entry ) , visit @ ( @ weeks after baseline ) , and visit @ ( @ weeks after baseline ; study end ) .


There were no significant differences in average patient age , duration of diabetes , duration of erectile dysfunction , baseline International Index of Erectile Function scores , hypertension , blood testosterone , smoking and alcohol consumption between two groups .


Mean International Index of Erectile Function scores were significantly higher for group B at the @-month ( @ @ vs @ @ ; P < @ ) and @-months ( @ @ vs @ @ ; P < @ ) visits .


Men in group B had better successful penetration ( @ % vs @ % ) and successful intercourse ( @ % vs @ % ) at @ months compared with group A.


Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function , and it is well tolerated by diabetes mellitus patients not responding to first-line sildenafil alone .


Direct health provider to patient presentation of coronary computed tomography angiography findings may increase adherence to preventive therapy and risk modification .


The purpose of this study was to assess the influence of visualization of coronary artery calcification and lifestyle recommendations on cholesterol concentrations and other risk variables in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia .


We performed a prospective @-center randomized controlled trial .


Patients were randomized @:@ to intervention or standard follow-up in general practice .


The primary end point was change in plasma total cholesterol concentration at @ months follow-up .


We included @ patients ( mean -LSB- standard deviation -RSB- age @ -LSB- @ -RSB- years , @ % were male ) .


Median ( range ) Agatston score was @ ( @-@ ) .


The reduction in plasma total cholesterol concentrations tended to be higher in the intervention group than in the control group , @ mg/dL versus @ mg/dL ( P = @ ) .


In a subgroup including patients continuing statin therapy during follow-up ( n = @ ) , the reduction in plasma total cholesterol concentrations was more pronounced in the intervention group than in the control group , @ mg/dL versus @ mg/dL ( P = @ ) .


In the intervention group , there was a higher degree of statin adherence and a higher proportion of patients who stopped smoking and commenced healthier dietary behavior than in the control group .


Visualization of coronary artery calcification and brief recommendations about risk modification after coronary computed tomography angiography in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia may have a favorable influence on plasma total cholesterol concentration , adherence to statin therapy , and risk behavior .


Further investigations are needed .


Inguinal hernia is the commonest type of external hernias .


Lichtenstein mesh repair is the most favoured technique of inguinal hernia repair nowadays .


It is tension free repair of weakened inguinal wall using polypropylene mesh .


The present study was conducted to determine the efficacy of single dose antibiotic with placebo on patients undergoing inguinal hernia mesh repair .


This randomised controlled trial was carried out in the Department of General Surgery , Ayub Teaching Hospital , Abbottabad from January to December @ .


The study population included male patients presenting with primary unilateral inguinal hernia , above @ years of age .


Mesh repair was performed in all patients .


The patients were randomly divided into two groups .


Patients in group A were given a single dose of antibiotic before inguinal hernia mesh repair and patients in group B were given placebo before inguinal hernia mesh repair .


Efficacy of antibiotic and placebo was accessed in terms of surgical site infections ( SSIs ) .


A total of @ cases of inguinal hernia mesh repair patients were recorded during the study period .


A total of @ patients were recruited in each group .


Surgical site infection was found in @ ( @ % ) in Group B it was @ ( @ % ) .


The difference being statistically significant ( p = @ ) .


Antibiotic prophylaxis is a preferred option for mesh plasty .


The purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test ( FIT + ) for a total colonoscopy ( TC ) .


FIT + patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and , for non-compliers , to be recalled by mail , for counselling with a general practitioner , or to meet with a specialist screening practitioner ( nurse or healthcare assistant ) .


In all , @ patients were randomised to different invitation strategies .


Compliance with an initial invitation by mail and by phone was similar ( @ % vs. @ % , relative risk - RR : @ ; @ % CI @-@ @ ) .


Among non-responders to the initial invitation , compliance with a recall by appointment with a specialist practitioner was @ % , significantly higher than with a mail recall ( @ % ; RR :@ ; @ % CI @-@ @ ) or with a face-to-face counselling with the GP ( @ % ; RR :@ ; @ % CI @-@ @ ) .


Compliance with an initial invitation for a TC by mail and by phone was similar .


A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations , while the involvement of GPs in this particular activity seemed less effective .


The aim of this study was to determine the effect of combined calcium and iron versus single iron supplementation on iron status in Bolivian schoolchildren .


Children ages @ to @ y old ( N = @ ) , were randomly assigned to receive either @ mg Ca ( as calcium carbonate ) plus @ mg Fe ( as ferrous sulfate ) ( Ca + Fe group ) or @ mg Fe ( as ferrous sulfate ) ( Fe group ) .


The doses were administered daily , from Monday to Friday , between meals at school over @ mo. .


Iron status was assessed at baseline and after intervention .


Additionally , overall nutritional status was assessed by anthropometry and an estimation of dietary intake .


At baseline , the prevalence of anemia in the Ca + Fe group and the Fe group were @ % and @ % , respectively .


After @ mo follow-up , the prevalence of iron deficiency anemia dropped significantly ( P < @ ) to @ % in both groups ( ( @ ) = NS ) .


Iron dietary intake was within recommended levels , but calcium intake only covered @ % of the Recommended Daily Intake .


Combined calcium and iron supplementation is equally as effective as single iron supplementation in reducing the prevalence of iron deficiency anemia in Bolivian school children .


The efficacy and safety of primary intraocular lens ( IOL ) implantation during early infancy is unknown .


To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy .


The Infant Aphakia Treatment Study is a randomized clinical trial with @ years of follow-up that involved @ infants with unilateral congenital cataracts at @ sites .


A traveling examiner assessed visual acuity at age @ years .


Cataract surgery with or without primary IOL implantation .


Contact lenses were used to correct aphakia in patients who did not receive IOLs .


Treatment was determined through random assignment .


HOTV optotype visual acuity at @ years of age .


The median logMAR visual acuity was not significantly different between the treated eyes in the @ treatment groups ( both , @ -LSB- @/@ -RSB- ; P = @ ) .


About @ % of treated eyes in both groups had visual acuity less than or equal to @/@ .


Significantly more patients in the IOL group had at least @ adverse event after cataract surgery ( contact lens , @ % ; IOL , @ % ; P = @ ) .


The most common adverse events in the IOL group were lens reproliferation into the visual axis , pupillary membranes , and corectopia .


Glaucoma/glaucoma suspect occurred in @ % of treated eyes in the contact lens group vs @ % of eyes in the IOL group ( P = @ ) .


Since the initial cataract surgery , significantly more patients in the IOL group have had at least @ additional intraocular surgery ( contact lens , @ % ; IOL , @ % ; P < @ ) .


There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic .


However , there were significantly more adverse events and additional intraoperative procedures in the IOL group .


When operating on an infant younger than @ months of age with a unilateral cataract , we recommend leaving the eye aphakic and focusing the eye with a contact lens .


Primary IOL implantation should be reserved for those infants where , in the opinion of the surgeon , the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia .


In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve .


Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered .


In addition to all these procedures mentioned above , one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A ( BTX-A ) .


We conducted a randomized , double-blind , placebo-controlled since November @ , and adopted local multi-point injection in @ cases of classical TN with different doses of BTX-A .


Eighty four patients were randomized into following groups : placebo ( n = @ ) ; BTX-A @U ( n = @ ) ; BTX-A @U ( n = @ ) .


Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were @weeks to observe the pain severity , efficacy and adverse reactions at endpoint .


The visual analogue scale ( VAS ) scores of @U and @U groups reduced significantly compared to placebo as early as week @ , and sustained until week @ throughout the study .


There was no significant difference in VAS between @U and @U groups throughout the study .


The response rates of @U group ( @ % ) and @U group ( @ % ) were significantly higher than placebo group ( @ % ) at week @ , and there was no significant difference between @U and @U groups .


Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that @ % ( @U group ) and @ % ( @U group ) of the patients reported that their pain symptoms were ` much improved ' or ` very much improved ' versus @ % of the placebo group , and there was also no significant difference between @U and @U groups .


All adverse reactions were graded as mild or moderate .


BTX-A injection in TN is safe and efficient .


It is a useful treatment for refractory TN .


Lower dose ( @U ) and high dose ( @U ) were similar in efficacy in short-term .


This study was aimed to explore the physiological changes and the effect of heat acclimation training via a randomized control trial study .


Forty healthy male volunteers were chosen and divided into experimental group and control group randomly .


Those in experimental group received heat acclimation training including but not limited to meditation , unarmed run , yoga , and stepping in hot lab environment .


And then , subjective feeling , rectal temperature , average skin temperature , and sweat electrolytes concentration were detected in order to describe their physiological changes .


Before and after the training , both groups received some tests and their @ @ m run-race time , nervous reaction time and subjective perception scores were recorded to evaluate the effect of acclimation training .


( @ ) There was no difference in @ @ m between the @ groups in the same environment .


Subjects ' @ @ m race time in experimental group was obviously shortened than that in control group in room temperature environment ( t = @ , P < @ ) .


And subjects ' @ @ m race time in experimental group was obviously shortened than that in control group in hot-humid environment ( t = @ , P < @ ) .


( @ ) Subjects ' reaction time ( RT ) in experimental group was shortened than that in control group in room temperature environment ( Z = @ , P < @ ) .


And Subjects ' RT in experimental group was sharply shortened than that in control group in hot-humid environment ( Z = @ , P < @ ) .


( @ ) No difference between the experimental and control groups was observed in subjective perception score ( SPS ) in room temperature environment .


But subjects ' SPS in experimental group was obviously lowered than that in control group and in hot-humid environment ( t = @ , P < @ ) .


( @ ) Anal temperature ( AT ) was lowered during training , while the change of mean skin temperature ( MST ) was not significant .


Sweat sodium concentration ( SSC ) was lowered during training .


SPS continued to decrease and entered plateau on the @th day after training .


( @ ) After acclimation training , the working capacity of the experimental group in hot-humid environment was over @ % of that in room temperature environment .


While subjects ' working capacity in control group in hot-humid environment was about @ % of that in room temperature environment .


Hot-humid environment acclimation training improved the working capacity .


After training , subjects ' working capacity in hot-humid environment remained over @ % of that in room temperature environment , which was higher than that of those subjects who did not take part in training .


The mammalian skin is a barrier that effectively separates the water-rich interior of the body from the normally dryer exterior .


Changes in the external conditions , for example ambient humidity , have been shown to affect the skin barrier properties .


The prime objective of this study was to evaluate the effect of water activity of a topical formulation on skin hydration and permeability .


A second objective was to gain more understanding on how two commonly used humectants , urea and glycerol , affect skin barrier function in vivo .


Simple aqueous formulations were applied under occlusion to the volar forearm of healthy volunteers .


Following @-h exposure , skin water loss ( by transepidermal water loss measurements ) , skin hydration ( by Corneometry ) and skin permeability ( by time to vasodilation due to benzyl nicotinate exposure ) were monitored .


The results demonstrate that a relatively small change in the water activity of a topical formulation is sufficient to induce considerable effects on stratum corneum hydration and permeability to exogenous substances .


Exposing the skin to high water activity leads to increased skin hydration and also increased permeability .


Furthermore , urea and glycerol promote skin hydration and permeability even at reduced water activity of the applied formulation .


These results highlight the importance of considering the water activity in topically applied formulations and the potential benefit of using humectants .


The results may impact formulation optimization in how to facilitate skin hydration and to modify skin permeability by temporarily open and close the skin barrier .


Internet - and mobile based stress-management interventions ( iSMI ) may be an effective means to address the negative consequences of occupational stress .


However , available results from randomised controlled trials are conflicting .


Moreover , it is yet not clear whether guided or unguided self-help iSMI provide better value for money .


Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional .


However , direct comparisons in randomised controlled trials are scarce and , to the best of our knowledge , the comparative ( cost ) - effectiveness of guided vs. unguided iSMI has not yet been studied .


Hence , this study investigates the acceptability and ( cost - ) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress .


A three-armed randomised controlled trial ( RCT ) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition ( WLC ) .


Both active conditions are based on the same iSMI , i.e. GET.ON Stress , and differ only with regard to the guidance format .


Employees with heightened levels of perceived stress ( PSS @ ) will be randomised to one of three conditions .


Primary outcome will be comparative changes in perceived stress ( PSS ) .


Secondary outcomes include changes in self-reported depression , work-engagement , presenteeism and absenteeism .


Moreover , a cost-effectiveness analysis will be conducted from a societal perspective , including both direct medical costs and costs related to productivity losses .


In addition , a cost-benefit analysis will be conducted from the employer 's perspective .


Incremental net-benefit regression analyses will address the question if there are any baseline factors ( i.e. subgroups of employees ) associated with particularly favorable cost-effectiveness when the experimental intervention is offered .


Assessments take place at baseline , @ weeks post-treatment and @ months after randomisation .


Online-based ( guided ) self-help interventions could be an acceptable , effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress .


This study evaluates the ( cost - ) effectiveness of two versions of an iSMI , minimal guided and unguided iSMI .


Thus , the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs .


The aim of this study was to examine the putative adverse effects of ambient fine particulate matter ( PM@ @ : PM with aerodynamic diameters < @ m ) on brain volumes in older women .


We conducted a prospective study of @,@ community-dwelling older women without dementia enrolled in the Women 's Health Initiative Memory Study , @-@ .


Structural brain magnetic resonance imaging scans were performed at the age of @-@ years in @-@ to obtain volumetric measures of gray matter ( GM ) and normal-appearing white matter ( WM ) .


Given residential histories and air monitoring data , we used a spatiotemporal model to estimate cumulative PM@ @ exposure in @-@ .


Multiple linear regression was employed to evaluate the associations between PM@ @ and brain volumes , adjusting for intracranial volumes and potential confounders .


Older women with greater PM@ @ exposures had significantly smaller WM , but not GM , volumes , independent of geographical region , demographics , socioeconomic status , lifestyles , and clinical characteristics , including cardiovascular risk factors .


For each interquartile increment ( @ g/m ( @ ) ) of cumulative PM@ @ exposure , the average WM volume ( WMV ; @ % confidence interval ) was @ cm ( @ ) ( @-@ @ ) smaller in the total brain and @ cm ( @ ) ( @-@ @ ) lower in the association areas , equivalent to @ to @ years of brain aging .


The adverse PM@ @ effects on smaller WMVs were present in frontal and temporal lobes and corpus callosum ( all p values < @ ) .


Hippocampal volumes did not differ by PM@ @ exposure .


PM@ @ exposure may contribute to WM loss in older women .


Future studies are needed to determine whether exposures result in myelination disturbance , disruption of axonal integrity , damages to oligodendrocytes , or other WM neuropathologies .


A randomized , controlled clinical trial .


This randomized controlled clinical trial was aimed at comparing the clinical outcomes of combined posteroanterior ( P-A ) fusion and transforaminal thoracic interbody fusion ( TTIF ) in cases of thoracolumbar fracture-dislocation .


The optimal treatment strategy for thoracolumbar fracture-dislocation remains controversial .


Sixty-one patients presenting with acute fracture-dislocation of the thoracolumbar joint between March @ and December @ were enrolled and randomly assigned to the P-A or TTIF group .


The radiological outcome was assessed by acquiring radiographs in the standing position and computed tomographic scans .


The clinical outcome was measured in terms of the American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index .


Moreover , we assessed the severity of overall morbidity and morbidity at the donor site in the @ patient groups .


The Student t and tests were used for the analysis of independent variables and categorical data , respectively .


Only @ of the enrolled patients were available for the required @-month follow-up period , @ underwent TTIF and @ underwent P-A fusion .


Both treatments were similar with respect to the fusion rate , extent of decompression , loss of correction , rate of instrumentation failure , American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index ( P > @ ) .


However , the blood loss , operating time , and rate of perioperative complications were greater in the P-A group than in the TTIF group ( P < @ ) .


The clinical and radiological outcomes were similar for both the treatment procedures .


However , our findings suggest that TTIF allows for safe interbody fusion and circumferential decompression , requires only a posterior approach , and is associated with a lower incidence of surgery-related complications .


To evaluate the follow-up efficacy and safety on slow transit constipation ( STC ) treated with individualized deep puncture at Tianshu ( ST @ ) .


One hundred and twenty-eight cases of STC were randomized into a deep puncture group ( @ cases ) , a western medication group ( @ cases ) and a shallow puncture group ( @ cases ) at the ratio of @:@:@ .


In the deep puncture group , electroacupuncture of deep puncture was applied to bilateral Tianshu ( ST @ ) .


The needle was inserted perpendicularly and slowly at the acupoint and went deeply till penetrating the peritoneum , about @ to @ mm in depth .


In the western medication group , lactulose oral liquid was prescribed for oral administration .


In the shallow puncture group , electroacupuncture of shallow puncture was done at bilateral Tianshu ( ST @ ) .


The needle was inserted perpendicularly and slowly , @ to @ mm in depth .


The treatment lasted @ weeks in the three groups and the follow-up visit of @ weeks and @ month after treatment was performed respectively .


The weekly defecation frequency , patient 's satisfaction and safety of deep puncture at Tianshu ( ST @ ) were assessed before and after treatment in each group .


In the deep puncture group , the weekly defecation frequency was ( @ + / - @ ) times/week before treatment and was ( @ + / - @ ) times/week after @-week treatment .


It was ( @ + / - @ ) times/week in @-week follow-up visit after treatment and was ( @ + / - @ ) times/week in @-month follow-up visit after treatment .


In the deep puncture group , the improvements in weekly defecation frequency , patient 's satisfaction and short-term efficacy were same as those in the western medication group and the shallow puncture group ( all P > @ ) .


The long-term efficacy in follow-up visit was better remarkably than that in the western medication group ( P < @ , P < @ ) .


Besides , the combined medication was reduced and no adverse reaction occurred .


The individualized deep puncture at Tianshu ( ST @ ) is effective in the treatment of STC and achieves the satisfactory long-term efficacy .


This therapy displays the good effective advantage and deserves to be promoted in clinical practice of acupuncture and moxibustion therapeutic program as compared with the first-tier line of medication , lactulose oral liquid , recommended at home and abroad , in terms of the evidence-based medicine .


Participant retention is an important challenge in longitudinal research on homeless people .


High attrition can threaten validity , and may represent lost opportunities to deliver interventions .


In this article , we report on attrition in the At Home/Chez Soi study , a multi-site randomized controlled trial of a housing intervention for homeless people with mental illness .


We first calculate life tables , and then use clustered logistic regression to implement a discrete-time survival model .


We use splines and indicator variables to capture non-linear and group-specific variation over time in the hazard function .


As potential predictors , we consider study group , site , date of recruitment , age , sex , baseline substance dependence , baseline psychotic disorder , time homeless in life , community functioning , and education .


The study recruited @,@ homeless people with mental illness .


Of these , @,@ were randomized to the housing first intervention ( HF ) , and @ to treatment as usual ( TAU ) .


Excluding @ people known to have died , attrition was @ % .


This proportion was higher in TAU than in HF ( @ vs. @ % , p < @ ) .


Attrition was significantly lower in one site than elsewhere , and was also lower among those with substance dependence ( @ vs. @ % , p < @ ) and among those enrolled earlier in the study .


The hazard varied over time in complex ways .


Results imply that study factors are more important than participant characteristics as determinants of retention , and that the immediate period after randomization is a crucial one .


The high overall retention demonstrates the effectiveness of existing techniques for retaining participants .


The main objective of the present work was to compare the effects of the gonadotropin-releasing hormone agonist ( GnRH-a ) and GnRH antagonist ( GnRH-ant ) on the gene expression profiles of oocytes obtained from Iranian infertile couples undergoing in vitro fertilization ( IVF ) .


Fifty infertile couples who underwent IVF between June @ and November @ at the Infertility Center of Tehran Women General Hospital , Tehran University of Medical Sciences , were included in this study .


We included women that had undergone IVF treatment because of male factor , tubal factor , or unexplained infertility .


The women randomly underwent controlled ovarian stimulation ( COS ) with either the GnRH-a ( n = @ ) or the GnRH-ant ( n = @ ) .


We obtained @ germinal vesicle ( GV ) oocytes donated by women in each group .


After the sampling , pool of @ GV oocytes for each group was separately analyzed by quantitative polymerase chain reaction ( qPCR ) .


The expression levels of Adenosine triphosphatase @ ( ATPase @ ) , Bone morphogenetic protein @ ( BMP@ ) , and Neuronal apoptosis inhibitory protein ( NAIP ) genes were significantly upregulated in the GnRH-ant group compared to the GnRH-a group , with the fold change of @ ( SD @ ) , @ ( SD @ ) , and @ ( SD @ ) , respectively , ( P < @ ) .


Growth differentiation factor @ ( GDF@ ) mRNA did not have any expression in the GnRH-a group ; however , GDF@ mRNA was expressed in the GnRH-ant group .


Finally , it was found that the genes involved in the DNA repairing and cell cycle checkpoint did not have any expression in either group .


The present study showed , for the first time , the expression levels of genes involved in the cytoplasmic maturity ( BMP@ , GDF@ ) , adenosine triphosphate production ( ATPase @ ) , and antiapoptotic process ( NAIP ) , in human GV oocytes were significantly higher in the GnRH-anta group than in the GnRH-a group in COS. .


Higher expression level of these genes when GnRH-ant protocol is applied , this protocol seems to be a more appropriate choice for women with poly cystic ovarian syndrome , because it can probably improve the expression of the aforementioned genes .


Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia ( TN ) .


The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN .


This was a randomized , single-blinded , placebo-control study carried out on @ Egyptian patients with intractable TN .


Patients received a one-time subcutaneous administration of BTX-A using `` follow the pain '' method .


The primary efficacy measure was reduction in pain severity on the @-cm VAS score as well as in paroxysms frequency from the baseline to week @ ( endpoint last observation carried forward -LSB- LOCF -RSB- ) .


Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint .


Pain reduction at the @-week endpoint was significant in BTX-A group ( p < @ ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of @ compared with a decrease of @ for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale .


These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases .


Hydroxyethyl starch ( HES ) @/@ @ is considered an effective plasma expander when compared to crystalloids .


There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation .


The aim of this study was to compare the effects of HES @/@ @ to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding , hemodynamic parameters , coagulation profile , transfusion requirements and clinical outcomes .


In this randomized , controlled trial , @ patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups : @ patients were allocated to receive a preload of @ mL.kg ( -@ ) of HES @/@ @ and @ patients received a preload of @ mL.kg ( -@ ) lactated Ringer solution before surgery .


Hemodynamic measurements , hemoglobin concentrations , biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure .


Patients received medical follow-up during their hospital stay and up to postoperative @ days .


Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay .


Secondary outcome were hemodynamic parameters , length of hospital stay , mortality and occurrence of clinical postoperative complications .


Red blood cell transfusion was required in @ % of patients in the HES group and in @ % in the Ringer group ( p = @ ) .


Postoperative infections were more frequently observed in the Ringer group ( @ % ) compared to the HES group ( @ ) , p = @ .


There were no significant differences between groups in mortality , hospital length of stay and clinical complications other than infection .


During hip arthroplasty , patients treated with hypervolemic hemodilution with hydroxyethyl starch @/@ @ required less transfusion and presented lower infection rate compared to patients who received lactated Ringer .


The use of ecstasy is a public health problem and is associated with a range of social costs and harms .


In recent years , there has been growing concern about the availability and misuse of new and emerging drugs designed to mimic the effects of illicit drugs , including ecstasy .


This , coupled with the fact that the age of use and the risk factors for using ecstasy and emerging drugs are similar , provides a compelling argument to implement prevention for these substances simultaneously .


The proposed study will evaluate whether a universal Internet-based prevention program , known as the Climate Schools : Ecstasy and Emerging Drugs Module , can address and prevent the use of ecstasy and emerging drugs among adolescents .


A cluster randomised controlled trial will be conducted among Year @ students ( aged @-@ years ) from @ secondary schools in Sydney , Australia .


Schools will be randomly assigned to either the Climate Schools intervention group or the control group .


All students will complete a self-report questionnaire at baseline , immediately post-intervention , and @ - , @ - and @-months post-baseline .


The primary outcome measures will include ecstasy and emerging drug-related knowledge , intentions to use these substances in the future , and the patterns of use of ecstasy and emerging drugs .


A range of secondary outcomes will also be assessed , including beliefs and attitudes about ecstasy and emerging drugs , peer pressure resistance , other substance use and mental health outcomes .


To our knowledge , this will be the first evaluation of an Internet-based program designed to specifically target ecstasy and NED use among adolescents .


If deemed effective , the Climate Schools : Ecstasy and Emerging Drugs Module will provide schools with an interactive and novel prevention program for ecstasy and emerging drugs that can be readily implemented by teachers .


To assess the effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy , and describe the technique in detail .


A randomized , double-blind , placebo-controlled study following the CONSORT criteria .


A university hospital .


Thirty-seven patients undergoing vaginal hysterectomy .


Patients received high-volume ( @mL ) ropivacaine @ % ( n = @ ) or saline ( n = @ ) infiltration using a systematic technique ensuring uniform delivery to all tissues incised , handled or instrumented during the procedure .


Pain , nausea , vomiting and opioid requirements were assessed for @ h as well as time spent in the post-anesthesia care unit and time to first mobilization .


Pain at rest was significantly reduced after one , four and eight hours in the ropivacaine group ( p@-@ @ ) .


Pain during coughing was significantly reduced after one and four hours ( p@ @ and p@ @ ) , and pain during movement was significantly reduced after four hours ( p@ @ ) .


Opioid requirements and time spent in the post-anesthesia care unit were significantly reduced in the ropivacaine group ( p < @ and p < @ , respectively ) , as well as the time to first mobilization ( p < @ ) .


Intra-operative systematic local infiltration analgesia reduces postoperative pain in patients undergoing vaginal hysterectomy , facilities mobilization and improves early recovery .


Impaired functional performance and decreased muscle strength and muscle atrophy generally persist for a long period after total hip arthroplasty ( THA ) .


To investigate the effects of weight-bearing ( WB ) and non-weight-bearing ( NWB ) exercises on functional performance , Harris hip score ( HHS ) , muscle strength and muscle thickness in women after THA .


A randomised , controlled trial .


Community .


Sixty-five women who had undergone unilateral or bilateral THA at least @ months before enrolment in the study .


Participants were randomly allocated to the following groups : WB ( n = @ ) , NWB ( n = @ ) and control ( n = @ ) groups .


Participants in the WB and NWB groups performed daily home exercise programs for @ weeks .


Functional performance ( timed up and go , sit-to-stand , stair climbing , walking speed and @-min walk test ) , HHS , isometric muscle strength of the hip and knee muscle and gluteus and quadriceps muscle thickness were measured at baseline and after @ weeks .


An intention-to-treat analysis revealed that both the intervention groups exhibited significant improvements in almost all functional performance measures compared with the control group .


Furthermore , the WB group showed significantly greater pre-post changes in the sit-to-stand and @-min walk test compared with the NWB group .


In terms of HHS , only the WB group showed significantly greater improvement compared with the control group .


Relative to the control group , improvements in all isometric strength measures were observed in both the intervention groups .


Significant improvement in quadriceps muscle thickness was observed in the WB group compared with the control group .


However , no significant difference was observed among the three groups in pre-post changes in gluteus muscle thickness .


WB and NWB home exercise programs were both effective for improving functional performance and muscle strength in women after THA .


However , the WB exercise was more effective than the NWB exercise for improving sit-to-stand ability and walking endurance .


In this study , we demonstrated that the WB exercise was more effective than the NWB exercise for improving functional performance in patients after THA .


To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug ( NSAID ) - refractory nonradiographic axial spondyloarthritis ( SpA ) .


The study population consisted of patients who met the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis ( as assessed by a radiologist at the central trial site ) , had a symptom duration of > @ months but < @ years , had a score of @ on the Bath Ankylosing Spondylitis Disease Activity Index , and had been treated unsuccessfully with @ NSAIDs .


Patients were randomized to receive etanercept @ mg/week or placebo and continued background NSAID treatment for @ weeks ( double-blind study ) ; during the subsequent open-label period , all patients received etanercept @ mg/week .


The primary study end point was meeting the ASAS criteria for @ % improvement ( ASAS@ ) at week @ .


Magnetic resonance imaging ( MRI ) of the sacroiliac joints and spine was performed at baseline and week @ .


One hundred six patients were randomized to the etanercept group and @ to the placebo group .


Of the @ patients , the mean SD age at baseline was @ @ years , @ ( @ % ) were HLA-B@ positive , and @ ( @ % ) had MRI-confirmed sacroiliitis .


At @ weeks , the proportion of patients with improvement according to the ASAS@ was significantly higher in the etanercept group than in the placebo group ( @ of @ -LSB- @ % -RSB- versus @ of @ -LSB- @ % -RSB- ; P = @ ) .


Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation ( -@ % versus -@ % ; P < @ ) and spinal inflammation ( -@ % versus -@ % ; P = @ ) compared with placebo-treated patients at week @ .


Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS@ response to etanercept .


At week @ , patients in the placebo group who had switched to etanercept at @ weeks exhibited improvement similar to that observed in patients who had received etanercept for @ weeks .


In patients with nonradiographic axial SpA , etanercept treatment was associated with rapid , significant improvement in symptomatic disease activity , function , and systemic and skeletal inflammation over @ weeks ; clinical/functional improvement was sustained over @ weeks .


Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes .


TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results .


Aim of this non-inferiority study is to report the @-year follow-up of a randomized , single-blind , controlled trial comparing TVT-O to TVT-Secur .


Randomized , single blind , controlled study conducted in two tertiary urogynecological centers .


@ patients were allocated to either TVT-O or TVT-Secur and were contacted @ years after the procedure to undergo urogynecological examination ( POP-Q staging , challenge stress test and post-void residual urine evaluation ) , to complete I-QOL and PGI-I questionnaires , and to score their satisfaction on a @-point Likert scale .


Patients who were not objectively evaluated were interviewed over the telephone .


Primary outcome was subjective success defined as being `` very much improved '' or `` much improved '' on the PGI-I .


@ patients were evaluated only subjectively ( TVT-O : @ ; TVT-Secur : @ ) and @ objectively and subjectively ( TVT-O : @ ; TVT-Secur : @ ) .


Subjective success ( @ % vs. @ % ) and objective cure rates ( @ % vs. @ % ) @ years after the procedure were lower for TVT-Secur , but not significantly .


Recurrent UTIs were reported by @ % of women ( TVT-O @ , TVT-Secur @ ) and two de novo urgency cases ( one per group ) were observed .


Re-operation rate for stress urinary incontinence ( SUI ) was @ % .


TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure , even though displaying a clear trend toward a lower efficacy .


Considering that the long-term safety profile is similar between the two procedures , there are no advantages in using TVT-Secur .


People with rheumatoid arthritis are at greater risk of morbidity and mortality from cardiovascular disease than the general population .


Sustained physical activity increases cardio-respiratory fitness and reduces cardiovascular disease risk factors .


However , little is known about how we can effectively promote long-term participation in physical activity in patients with rheumatoid arthritis .


The literature consistently calls for physical activity interventions , and their implementation , to be theoretically-grounded .


This paper documents the protocol of a randomised control trial that investigates whether a Self-determination Theory-based intervention fosters the adoption and maintenance of physical activity ( @ , @ and @ months ) sufficient to provide sustained cardiovascular and personal well-being benefits in patients with rheumatoid arthritis .


The cost effectiveness of the intervention will also be determined .


The trial is registered as Current Controlled Trials ISRCTN@ .


Results from this trial will provide guidance regarding key social environmental factors that can be manipulated to support motivational processes conducive to positive health behaviour change and optimal functioning in patients with Rheumatoid Arthritis .


This study aimed to assess changes in oral health-related quality of life ( OHRQoL ) in individuals enroled in a double-blind randomized clinical trial conducted to evaluate the efficacy and safety of two carbamide peroxide concentrations used in at-home vital bleaching in the city of Pelotas , Southern Brazil .


Ninety-two volunteers with a shade mean of C@ or darker for the six maxillary anterior teeth were randomized into two balanced groups ( n = @ ) according to bleaching agent concentration : @ % or @ % carbamide peroxide .


The patients were instructed to use the whitening agent in a tray for @h once a day for three weeks .


To assess changes in OHRQoL , participants completed the oral impact on daily performance ( OIDP ) at the start and one week after the completion of treatment .


Because there was no difference with regard to whitening effect or tooth sensitivity during or after treatment the two groups were merged for the analyses of the current article .


Before-and-after changes in OIDP scores were assessed by chi-square and McNemar tests ( p < @ ) .


Mean pre - and post-treatment OIDP scores varied from @ to @ .


When the frequency of impacts for different activities were compared , there was an increase in difficulty in cleaning teeth ( p = @ ) and a significant reduction in smiling and showing teeth with embarrassment ( p = @ ) .


Regarding the symptoms and main oral conditions that generated impact , there was higher number of participants reporting pain ( p = @ ) after treatment .


In opposite , significant decrease was observed in individuals reporting being unhappy with their appearance ( p = @ ) .


On the contrary , it was showed a decrease in impacts resulting from dental colour was observed after bleaching ( p = @ ) .


Quality of life is complex and encompasses different domains .


Although positive impact of the dental bleaching was detected , with patients showing more their teeth without embarrassment , difficult in dental hygiene and pain resulting from the treatment were also reported , and this can negatively impact daily performances .


Dentists must consider these aspects when performing aesthetics procedures .


The long-term efficacy of microwave hyperthermia combined with chemoradiotherapy in treating nasopharyngeal carcinoma ( NPC ) with metastatic foci in cervical lymph nodes was evaluated .


A total of @ cases of N@ or N@ stage NPC were randomized into two groups : hyperthermia group ( @ cases ) and control group ( @ cases ) .


Both received cisplatin chemotherapy and radiotherapy .


In addition , the hyperthermia group further received microwave hyperthermia to the metastatic cervical nodes with different patterns ( before or after radiotherapy ) , heating temperatures ( T@ < @ and T@ @ ) and hyperthermia episodes ( < @ times , @-@ times and > @ times ) .


The @-month and @-year complete response ( CR ) rates of cervical lymph nodes in the hyperthermia group were significantly higher than those in the control group .


The @-year disease-free survival ( DFS ) rate and the @-year / @-year overall survival rate in the hyperthermia group were also significantly higher .


There was no significant difference in @-year metastatic rates .


In the hyperthermia group , the @-month and @-year CR rates of T@ < @ treatment were significantly lower than with T@ @ treatment .


The CR rate was highest when the hyperthermia was performed @-@ times .


There were no significant differences in @-month and @-year CR rates between hyperthermia before or after radiotherapy treatment .


Microwave hyperthermia combined with chemoradiotherapy can increase local control , DFS and @ , @-year overall survival rates of patients with N@ ~ N@ stage NPC .


The heating temperature should be over @ with hyperthermia repeated @-@ times .


Bariatric surgery may be beneficial in mildly obese patients with poorly controlled diabetes .


The optimal procedure to achieve diabetes remission is unknown .


In @ , we published the short-term results of a pilot study designed to evaluate the efficacy of diabetic control and the role of duodenal exclusion in mildly obese diabetic patients undergoing laparoscopic sleeve gastrectomy ( SG ) vs. a laparoscopic single anastomosis ( mini - ) gastric bypass ( SAGB ) .


This study analyzes the @-year results and evaluates the incretin effect .


A double-blind randomized trial included @ participants with a hemoglobin A@c ( HbA@c ) level higher than @ % , a body mass index ( BMI ) between @ and @ Kg/m ( @ ) , a C-peptide level @ ng/mL , and a diagnosis of type @ diabetes mellitus ( T@DM ) for at least @ months .


A SAGB with duodenal exclusion or a SG without duodenal exclusion was performed .


The @-year results of the primary outcome were as an intention-to-treat analysis for HbA@c @ % without glycemic therapy .


Assessments of the incretin effect and cell function were performed at baseline and between @ and @ months .


The patients were randomly assigned to SAGB ( n = @ ) and SG ( n = @ ) .


At @ months , @ participants ( @ % ; @ % confidence interval ( CI ) , @ to @ % ) in the SAGB group and nine participants ( @ % ; @ % CI , @ to @ % ) in the SG group achieved the primary end points ( odds ratio ( OR ) , @ ; @ % CI , @ to @ % ) .


The participants assigned to the SAGB procedure had a similar percentage of weight loss as the SG patients ( @ vs. @ % ; p > @ ) but achieved a lower level of HbA@c ( @ vs. @ % ; p < @ ) than the SG patients .


There was a significant increase in the incretin effect before and after surgery in both groups , but the SAGB group had a higher incretin effect than the SG group at @ years .


In mildly obese patients with T@DM , SG is effective at improving glycemic control at @ years , but SAGB was more likely to achieve better glycemic control than SG and had a higher incretin effect compared to SG .


We evaluated the effectiveness of a low-intensity , home-based physical activity program ( Onco-Move ) and a moderate - to high-intensity , combined supervised resistance and aerobic exercise program ( OnTrack ) versus usual care ( UC ) in maintaining or enhancing physical fitness , minimizing fatigue , enhancing health-related quality of life , and optimizing chemotherapy completion rates in patients undergoing adjuvant chemotherapy for breast cancer .


We randomly assigned patients who were scheduled to undergo adjuvant chemotherapy ( N = @ ) to Onco-Move , OnTrack , or UC .


Performance-based and self-reported outcomes were assessed before random assignment , at the end of chemotherapy , and at the @-month follow-up .


We used generalized estimating equations to compare the groups over time .


Onco-Move and OnTrack resulted in less decline in cardiorespiratory fitness ( P < @ ) , better physical functioning ( P @ ) , less nausea and vomiting ( P = @ and @ , respectively ) and less pain ( P = @ and @ , respectively ) compared with UC .


OnTrack also resulted in better outcomes for muscle strength ( P = @ ) and physical fatigue ( P < @ ) .


At the @-month follow-up , most outcomes returned to baseline levels for all three groups .


A smaller percentage of participants in OnTrack required chemotherapy dose adjustments than those in the UC or Onco-Move groups ( P = @ ) .


Both intervention groups returned earlier ( P = @ ) , as well as for more hours per week ( P = @ ) , to work than the control group .


A supervised , moderate - to high-intensity , combined resistance and aerobic exercise program is most effective for patients with breast cancer undergoing adjuvant chemotherapy .


A home-based , low-intensity physical activity program represents a viable alternative for women who are unable or unwilling to follow the higher intensity program .


Distress and pain associated with immunisation are significant problems for children , carers and healthcare professionals .


This study was designed to determine whether distraction by watching cartoons during immunisation could reduce the distress and pain perceived by the children .


A sample of @ six year olds was randomly assigned to one of two groups : the first was distracted by standard techniques during immunisation , the second by watching cartoons .


Levels of distress were measured with the amended observation scale of behavioural distress , and of pain by the Wong-Baker FACES pain rating scale .


The levels of distress were significantly lower in the group distracted by cartoons compared with children who received traditional distraction techniques during immunisation .


By using an easy , cheap intervention , children 's first introduction to health services can be made a positive experience which will decrease the number developing pre-procedural anxiety or a fear of needles .


To assess for the frequency of binge eating behavior and its association with weight loss in an overweight/obese sample of veterans .


This study is a secondary analysis of data from the ASPIRE study , a randomized effectiveness trial of weight loss among veterans .


Of the @ enrolled veterans with overweight/obesity , binge eating frequency was obtained by survey for @ ( @ % ) .


The majority ( @ % ) reported binge eating , and @ % reported high-frequency binge eating .


Those reporting any binge eating lost @ % of body weight , decreased waist circumference by @ cm , and had significantly worse outcomes than those reporting never binge eating who lost about double the weight ( @ % ) and reduced waist circumference by twice as much ( @ cm ) .


The high-frequency binge group gained @ % of body weight and increased waist circumference by @ cm .


High rates of binge eating were observed in an overweight/obese sample of veterans enrolled in weight loss treatment .


The presence of binge eating predicted poorer weight loss outcomes .


Furthermore , high-frequency binge eating was associated with weight gain .


These findings have operational and policy implications for developing effective strategies to address binge eating in the context of behavioral weight loss programs for veterans .


Urinary tract infections ( UTIs ) are common drivers of antibiotic use .


The minimal effective duration of antibiotic therapy for UTIs is unknown , but any reduction is important to diminish selection pressure for antibiotic resistance , costs , and drug-related side-effects .


The aim of this study was to investigate whether an algorithm based on procalcitonin ( PCT ) and quantitative pyuria reduces antibiotic exposure .


From April @ to March @ , we conducted a factorial design randomized controlled open-label trial .


Immunocompetent adults with community-acquired non-catheter-related UTI were enrolled in the emergency department of a tertiary-care @-bed hospital in northwestern Switzerland .


Clinical presentation was used to guide initiation and duration of antibiotic therapy according to current guidelines ( control group ) or with a PCT-pyuria-based algorithm ( PCT-pyuria group ) .


The primary endpoint was overall antibiotic exposure within @ days .


Secondary endpoints included duration of the initial antibiotic therapy , persistent infection @ days after end of therapy and @ days after enrollment , recurrence and rehospitalizations within @ days .


Overall , @ patients were screened , @ met predefined exclusion criteria , @ declined to participate , and @ were not eligible .


Of these , @ ( @ % women ) were enrolled in the intention-to-treat ( ITT ) analysis and @ patients with microbiologically confirmed UTI constituted the per protocol group ; @ of @ ( @ % ) patients had a febrile UTI , @ ( @ % ) had bacteremia , @ ( @ % ) died , and @ ( @ % ) were lost to follow-up .


Overall antibiotic exposure within @ days was shorter in the PCT-pyuria group than in the control group ( median @ -LSB- IQR , @-@ @ -RSB- vs. @ -LSB- IQR , @-@ @ -RSB- days , P = @ ) in the ITT analysis .


Mortality , rates of persistent infections , recurrences , and rehospitalizations were not different .


A PCT-pyuria-based algorithm reduced antibiotic exposure by @ % when compared to current guidelines without apparent negative effects on clinical outcomes .


Patients with relapsed chronic lymphocytic leukemia ( CLL ) who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy .


Effective therapies with acceptable side-effect profiles are needed for this patient population .


In this multicenter , randomized , double-blind , placebo-controlled , phase @ study , we assessed the efficacy and safety of idelalisib , an oral inhibitor of the delta isoform of phosphatidylinositol @-kinase , in combination with rituximab versus rituximab plus placebo .


We randomly assigned @ patients with decreased renal function , previous therapy-induced myelosuppression , or major coexisting illnesses to receive rituximab and either idelalisib ( at a dose of @ mg ) or placebo twice daily .


The primary end point was progression-free survival .


At the first prespecified interim analysis , the study was stopped early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy .


The median progression-free survival was @ months in the placebo group and was not reached in the idelalisib group ( hazard ratio for progression or death in the idelalisib group , @ ; P < @ ) .


Patients receiving idelalisib versus those receiving placebo had improved rates of overall response ( @ % vs. @ % ; odds ratio , @ ; P < @ ) and overall survival at @ months ( @ % vs. @ % ; hazard ratio for death , @ ; P = @ ) .


Serious adverse events occurred in @ % of the patients receiving idelalisib and rituximab and in @ % of those receiving placebo and rituximab .


The combination of idelalisib and rituximab , as compared with placebo and rituximab , significantly improved progression-free survival , response rate , and overall survival among patients with relapsed CLL who were less able to undergo chemotherapy .


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


We characterized the incidence of central nervous system ( CNS ) metastases after treatment with trastuzumab emtansine ( T-DM@ ) versus capecitabine-lapatinib ( XL ) , and treatment efficacy among patients with pre-existing CNS metastases in the phase III EMILIA study .


In EMILIA , patients with human epidermal growth factor receptor @ ( HER@ ) - positive advanced breast cancer previously treated with trastuzumab and a taxane were randomized to T-DM@ or XL until disease progression .


Patients with treated , asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases were identified retrospectively by independent review ; exploratory analyses were carried out .


Among @ randomized patients ( T-DM@ = @ ; XL = @ ) , @ ( T-DM@ = @ ; XL = @ ) had CNS metastases at baseline .


CNS progression occurred in @ of @ ( @ % ) and @ of @ ( @ % ) patients without CNS metastases at baseline in the T-DM@ and XL arms , respectively , and in @ of @ ( @ % ) and @ of @ ( @ % ) patients with CNS metastases at baseline .


Among patients with CNS metastases at baseline , a significant improvement in overall survival ( OS ) was observed in the T-DM@ arm compared with the XL arm -LSB- hazard ratio ( HR ) = @ ; P = @ ; median , @ versus @ months -RSB- .


Progression-free survival by independent review was similar in the two treatment arms ( HR = @ ; P = @ ; median , @ versus @ months ) .


Multivariate analyses demonstrated similar results .


Grade @ adverse events were reported in @ % and @ % of patients with CNS metastases at baseline administered T-DM@ and XL , respectively ; no new safety signals were observed .


In this retrospective , exploratory analysis , the rate of CNS progression in patients with HER@-positive advanced breast cancer was similar for T-DM@ and for XL , and higher overall in patients with CNS metastases at baseline compared with those without CNS metastases at baseline .


In patients with treated , asymptomatic CNS metastases at baseline , T-DM@ was associated with significantly improved OS compared with XL .


to analyze the morphological structure of cardiac , blood pressure ( BP ) , heart rate ( HR ) and heart rate variability ( HRV ) of rats subjected to physical training with supplementation of caffeine .


@ rats were divided into @ groups : control ( CO ) , control with caffeine ( CAF ) , trained control ( TRE ) and trained with caffeine ( TCAF ) .


All trained groups underwent @ weeks of swimming , and all caffeine groups were supplemented by voluntary ingestion of caffeine diluted in drinking water .


there were no changes to BP and HR between groups .


Regarding HRV , there was a decrease in LFnorm ( low frequency ) and LF/HF ratio ( low and high frequency ) in TCAF and CAF compared to group ( p < @ and p < @ , respectively ) .


An increase occurred in CAF compared to the CO in the component LFnorm ( p < @ ) .


The results also showed an increase in the relative weight of heart in the TRE ( p < @ ) and TCAF ( p < @ ) compared to CO. .


caffeine did not modify the hemodynamic responses .


However , physical training resulted in a decrease in sympathetic response and an increase in relative heart weight .


Mexico 's sugar-sweetened beverage ( SSB ) intake is among the highest globally .


Although evidence shows that increases in SSB intake are linked with increased energy intake , weight gain , and cardiometabolic risks , few randomized clinical trials have been conducted in adults .


The aim of this study was to determine if replacing SSBs with water affects plasma triglycerides ( TGs ) ( primary outcome ) , weight , and other cardiometabolic factors .


We selected overweight/obese ( BMI @ and < @ kg/m ( @ ) ) women ( @-@ y old ) reporting an SSB intake of at least @ kcal/d living in Cuernavaca , Mexico .


Women were randomly allocated to the water and education provision ( WEP ) group ( n = @ ) or the education provision ( EP ) - only group ( n = @ ) .


The WEP group received biweekly water deliveries , and both groups received equal monthly nutrition counseling .


During nutrition counseling , the WEP group sessions included activities to encourage increased water intake , reduced SSB intake , and substitution of water for SSBs .


Repeated @-h dietary recalls , anthropometric measurements , and fasting blood samples were collected at baseline and at @ , @ , and @ mo. .


The Markov-Monte Carlo method was used for multiple imputation ; separate mixed-effects models tested each outcome .


An intent-to-treat ( ITT ) analysis indicated that the WEP group increased water intake and decreased SSB intake significantly over time , but there were no differences in plasma TG concentrations between groups at the end of the intervention ( WEP at baseline : @ @ mg/dL ; WEP at @ mo : @ @ mg/dL ; EP at baseline : @ @ mg/dL ; EP at @ mo : @ @ mg/dL ; P for mean comparisons at @ mo = @ ) .


Secondary analyses showed significant effects on plasma TGs ( change from baseline to @ mo : WEP , -@ @ mg/dL ; EP , @ @ mg/dL ; P = @ ) and metabolic syndrome ( MetS ) prevalence at @ mo ( WEP : @ % ; EP : @ % ; P = @ ) among obese participants .


Providing water and nutritional counseling was effective in increasing water intake and in partially decreasing SSB intake .


We found no effect on plasma TGs , weight , and other cardiometabolic risks in the ITT analysis , although the intervention lowered plasma TGs and MetS prevalence among obese participants .


Further studies are warranted .


This trial was registered at http://www.clinicaltrials.gov as NCT@ .


To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease ( CVD ) or at similarly high cardiovascular risk .


A within-trial cost analysis of polypill-based care versus usual care with separate medications , using data from the Kanyini Guidelines Adherence with the Polypill ( GAP ) trial and linked health service and medication administrative claims data .


Kanyini GAP participants who consented to Australian Medicare record access .


Mean health service and pharmaceutical expenditure per patient per year , estimated with generalised linear models .


Costs during the trial ( randomisation January @ - May @ , median follow-up @ months , maximum follow-up @ months ) were inflated to @ costs .


Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $ @ ( @ % CI , $ @ - $ @ ) per patient per year in the polypill arm compared with usual care ( P < @ ; adjusted , excluding polypill cost ) .


No significant difference was shown in health service expenditure .


This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy .


The savings will be less now than during the trial due to subsequent reductions in the costs of usual care .


Nonetheless , given the prevalence of CVD in Australia , the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia .


Fingolimod has shown reductions in clinical and MRI disease activity in patients with relapsing-remitting multiple sclerosis .


We further assessed the efficacy and safety of fingolimod in such patients .


We did this placebo-controlled , double-blind phase @ study predominantly in the USA ( @ of @ centres ) .


Using a computer-generated sequence , we randomly allocated eligible patients-those aged @-@ years with relapsing-remitting multiple sclerosis-to receive fingolimod @ mg , fingolimod @ mg , or placebo orally once daily ( @:@:@ ; stratified by study centre ) .


On Nov @ , @ , all patients assigned to fingolimod @ mg were switched to the @ mg dose in a blinded manner after a review of data from other phase @ trials and recommendation from the data and safety monitoring board , but were analysed as being in the @ mg group in the primary outcome analysis .


Our primary endpoint was annualised relapse rate at month @ , analysed by intention to treat .


Secondary endpoints included percentage brain volume change ( PBVC ) from baseline and time-to-disability-progression confirmed at @ months .


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


Between June @ , @ , and March @ , @ , we enrolled and randomly allocated @ patients : @ to fingolimod @ mg , @ to fingolimod @ mg , and @ to placebo .


Mean annualised relapse rate was @ ( @ % CI @-@ ) in patients given placebo and @ ( @-@ ) in patients given fingolimod @ mg : rate ratio @ ( @ % CI @-@ ; p < @ ) , corresponding to a reduction of @ % with fingolimod @ mg versus placebo .


Mean PBVC was -@ ( SD @ ) for fingolimod @ mg versus -@ ( @ ) for placebo ( treatment difference -@ , @ % CI -@ to -@ ; p = @ ) .


We recorded no statistically significant between-group difference in confirmed disability progression ( hazard rate @ with fingolimod @ mg vs placebo ; @ % CI @-@ ; p = @ ) .


Fingolimod @ mg caused more of the following adverse events versus placebo : lymphopenia ( @ -LSB- @ % -RSB- patients vs @ patients ) , increased alanine aminotransferase ( @ -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) , herpes zoster infection ( nine -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) , hypertension ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , first-dose bradycardia ( five -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) , and first-degree atrioventricular block ( @ -LSB- @ % -RSB- vs seven -LSB- @ % -RSB- ) .


@ ( @ % ) of @ patients given fingolimod @ mg and @ ( @ % ) of @ patients given placebo had serious adverse events over @ months , which included basal-cell carcinoma ( ten -LSB- @ % -RSB- patients vs two -LSB- @ % -RSB- patients ) , macular oedema ( three -LSB- @ % -RSB- vs two -LSB- @ % -RSB- ) , infections ( @ -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ) , and neoplasms ( @ -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) .


Our findings expand knowledge of the safety profile of fingolimod and strengthen evidence for its beneficial effects on relapse rates in patients with relapsing-remitting multiple sclerosis .


We saw no effect of fingolimod on disability progression .


Our findings substantiate the beneficial profile of fingolimod as a disease-modifying agent in the management of patients with relapsing-remitting multiple sclerosis .


To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device ( IUD ) in the prevention of adhesion reformation after hysteroscopic adhesiolysis .


Prospective , randomized , controlled trial .


University hospital .


A total of @ women with Asherman syndrome .


Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis .


The devices were removed after @days .


A second-look hysteroscopy was carried out @ to @months after the surgery .


Incidence of adhesion reformation and reduction of adhesion score before and after surgery .


Initially @ cases were recruited ; @ cases dropped out , resulting in @ cases in the balloon group and @ cases in IUD group .


The age , menstrual characteristics , pregnancy history , and American Fertility Society score before surgery were comparable between the two groups .


The median adhesion score reduction ( balloon group , @ ; IUD group , @ ) and the adhesion reformation rate ( balloon group , @ % ; IUD group , @ % ) were not significantly different between the two groups .


The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome .


Heterogeneous clinical presentation and gender differences were reported in Charcot-Marie-Tooth disease type @A ( CMT@A ) .


This report examined demographic and clinical data collected during a randomised controlled trial , to describe the clinical spectrum of a large and well-defined cohort of CMT@A patients .


Among the @ symptomatic patients screened , three patients ( @ % ) reported first symptoms in the upper limbs , which may be misleading when establishing the clinical diagnosis .


The quality of life ( QoL ) of patients was significantly deteriorated compared to the standard population , and slightly better compared to multiple sclerosis patients .


According to the literature , patients reported several disorders which may be associated with CMT@A , including auditory dysfunction ( @ % ) , Carpal Tunnel Syndrome ( CTS ) ( @ % ) or sleep apnoea ( @ % ) .


Compared to available data , we reported more patients with CTS and fewer patients with sleep apnoea .


Women were more affected by CTS than men ( @ % and @ % , respectively ) .


Women also reported an earlier onset of symptoms than men ( @ years and @ years , respectively ) , higher deterioration of their QoL and higher disability of their upper limb , assessed by Overall Neuropathy Limitation Scale ( p = @ ) .


This information will be useful for better understanding of this disease and for designing future clinical studies .


Olive oil polyphenols have shown protective effects on cardiovascular risk factors .


Their consumption decreased oxidative stress biomarkers and improved some features of the lipid profile .


However , their effects on LDL concentrations in plasma and LDL atherogenicity have not yet been elucidated .


Our objective was to assess whether the consumption of olive oil polyphenols could decrease LDL concentrations -LSB- measured as apolipoprotein B-@ ( apo B-@ ) concentrations and the total number of LDL particles -RSB- and atherogenicity ( the number of small LDL particles and LDL oxidizability ) in humans .


The study was a randomized , cross-over controlled trial in @ healthy European men , aged @-@ y , in the context of the EUROLIVE ( Effect of Olive Oil Consumption on Oxidative Damage in European Populations ) study .


Volunteers ingested @ mL/d raw low-polyphenol-content olive oil ( LPCOO ; @ mg/kg ) or high-polyphenol-content olive oil ( HPCOO ; @ mg/kg ) for @ wk .


Interventions were preceded by @-wk washout periods .


Effects of olive oil polyphenols on plasma LDL concentrations and atherogenicity were determined in the sample of @ men .


Effects on lipoprotein lipase ( LPL ) gene expression were assessed in another sample of @ men from the EUROLIVE study .


Plasma apo B-@ concentrations and the number of total and small LDL particles decreased ( mean SD : by @ % @ % , @ % @ % , and @ % @ % , respectively ) from baseline after the HPCOO intervention .


These changes differed significantly from those after the LPCOO intervention , which resulted in significant increases of @ % @ % , @ % @ % , and @ % @ % from baseline ( P < @ ) .


LDL oxidation lag time increased by @ % @ % from baseline after the HPCOO intervention , which was significantly different only relative to preintervention values ( P = @ ) .


LPL gene expression tended to increase by @ % from baseline after the HPCOO intervention ( P = @ ) and did not change after the LPCOO intervention .


The consumption of olive oil polyphenols decreased plasma LDL concentrations and LDL atherogenicity in healthy young men .


This trial was registered at www.controlled-trials.com as ISRCTN@ .


Hepatitis B virus ( HBV ) reactivation is a serious complication for patients with lymphoma treated with rituximab-containing chemotherapies , despite lamivudine prophylaxis treatment .


An optimal prophylactic antiviral protocol has not been determined .


To compare the efficacy of entecavir and lamivudine in preventing HBV reactivation in patients seropositive for the hepatitis B surface antigen with untreated diffuse large B-cell lymphoma receiving chemotherapy treatment with rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ( R-CHOP ) .


Randomized , open-label , phase @ study conducted from February @ through December @ at @ medical centers in China .


This study was a substudy of a parent study designed to compare a @-week with a @-week R-CHOP chemotherapy regimen for untreated diffuse large B-cell lymphoma .


Patients enrolled in the parent study who were seropositive for the hepatitis B surface antigen and had normal liver function , serum HBV DNA levels of less than @ copies/mL , and no prior antiviral therapy were randomized to entecavir ( n = @ ) or lamivudine ( n = @ ) .


Daily entecavir ( @ mg ) or lamivudine ( @ mg ) beginning @ week before the initiation of R-CHOP treatment to @ months after completion of chemotherapy .


The primary efficacy end point was the incidence of HBV-related hepatitis .


The secondary end points included rates of HBV reactivation , chemotherapy disruption due to hepatitis , and treatment-related adverse events .


There were @ patients randomly assigned to receive entecavir ( n = @ ) or lamivudine ( n = @ ) .


The date of last patient follow-up was May @ , @ .


The rates were significantly lower for the entecavir group vs the lamivudine group for HBV-related hepatitis ( @ % vs @ % , respectively ; difference between groups , @ % -LSB- @ % CI , @ % to @ % -RSB- ; P = @ ) , HBV reactivation ( @ % vs @ % ; difference , @ % -LSB- @ % CI , @ % to @ % -RSB- ; P = @ ) , and chemotherapy disruption ( @ % vs @ % ; difference , @ % -LSB- @ % CI , @ % to @ % -RSB- ; P = @ ) .


Of the @ patients in the entecavir group , @ ( @ % ) experienced treatment-related adverse events .


Of @ patients in the lamivudine group , @ ( @ % ) experienced treatment-related adverse events ( difference between entecavir and lamivudine groups , @ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) .


Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy , the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation .


If replicated , these findings support the use of entecavir in these patients .


Propofol ( PRO ) and dexmedetomidine ( DEX ) are commonly used to produce anesthesia and sedation for routine MRI procedures .


Children with complex conditions often require much lengthy MRI for multi-body-part scans with frequent scanner coil changes and patient body reposition .


This study compared PRO and DEX techniques on outcomes for the particular MRI setting with longer than @ h duration .


@ children , aged from @ to @ years , scheduled for MRI > @ min were randomly assigned to PRO or DEX group .


After induced with sevoflurane , a loading dose of PRO ( @ mgkg ( -@ ) ) was administrated and followed by continuous infusion ( @ gkg ( -@ ) min ( -@ ) ) ; a loading dose of DEX ( @ gkg ( -@ ) ) was administrated and followed by continuous infusion ( @ gkg ( -@ ) h ( -@ ) ) .


Patients received O ( @ ) by nasal cannula .


The observed outcomes were times for induction , MRI , emergence , and recovery , and total time ( induction to discharge ) ; MRI pauses from patient movement ; incidence of technique failure and critical events ; emergence and behavior in postanesthesia care unit ( PACU ) ; parental satisfaction ; and arterial pressure ( BP ) and heart rate ( HR ) during anesthesia .


PRO compared with DEX showed significantly less time for anesthesia induction ( @ versus @ min ) , emergence ( @ versus @ min ) , PACU ( @ versus @ min ) , and total time ( @ versus @ min ) ( all P < @ ) .


There were significantly fewer pauses during MRI and lower failure rate to complete MRI in PRO versus DEX ( @ versus @ , P = @ and @ versus @ , P < @ ) , less behavioral disturbances in PACU , and higher parental satisfaction in PRO versus DEX ( P < @ ) .


There were no critical events in either group : In PRO , mean BP during MRI ( from @ @ to @ mmHg ) was significantly less than before anesthesia ( @ @ mmHg ) , while HR remained relatively constant ( range of @-@ ) at its baseline of @ @ , but in DEX , mean BP remained unchanged ( from @ @ to @ @ ) during anesthesia compared with before anesthesia ( @ @ mmHg ) , while HR decreased ( @ @ to @ @ ) during anesthesia from its baseline ( @ @ ) .


For children undergoing lengthy multicomponent MRI , the propofol technique yielded overall better outcomes than the dexmedetomedine technique in terms of timeliness , PACU emergence characteristics , and parental satisfaction .


Both metformin and acarbose are recommended monotherapy and add-on therapy in type @ diabetes mellitus ( T@DM ) .


A fixed-dose combination ( FDC ) of acarbose and metformin has been developed to reduce pill burden and potentially improve compliance .


The current study investigated the bioequivalence of the acarbose/metformin FDC compared with the individual agents administered simultaneously ( loose combination ) .


Secondary endpoints were the safety and tolerability of the FDC and the potential for drug-drug interactions between acarbose and metformin .


A single-centre , randomized , open-label , four-period crossover study was conducted in healthy male Korean subjects aged @-@years .


Following one-period balanced Williams design , participants were randomized to receive four single oral treatments on different study days separated by @days ' washout .


Treatments were as follows : ( i ) acarbose/metformin @/@mg FDC ( test ) ; ( ii ) acarbose @mg and metformin @mg as loose combination ( reference ) ; ( iii ) acarbose @mg ; and ( iv ) metformin @mg .


Serial blood samples were taken for glucose and insulin levels for @h after a sucrose load on the day before and day of study drug administration .


Additionally , serial blood samples were taken for analysis of metformin levels for @h after each drug containing metformin .


The area under the curve for @h post-test ( AUC@-@h ) and the maximal serum concentration ( Cmax ) of plasma glucose and serum insulin were primary pharmacodynamic ( PD ) parameters , and Cmax , AUC@-last and AUC for metformin levels were primary pharmacokinetic ( PK ) parameters .


The bioequivalence of the FDC to the loose combination was considered established if the @ % confidence intervals ( CIs ) of the baseline-adjusted PD parameter ratios ( test vs. reference ) for plasma glucose and the PK parameter ratios for metformin fell completely within current acceptance limits ( @-@ ) .


Thirty-three of @ randomized subjects completed the study ; five withdrew consent and two discontinued because of adverse events ( AEs ) .


The @-h plasma concentration-time curves of metformin and the @-h plasma glucose-time curves after acarbose/metformin FDC ( test ) and acarbose + metformin loose combination ( reference ) were almost superimposable .


The geometric least squares ( LS ) mean of the RatioAUC and RatioCmax for plasma glucose after the FDC vs. loose combination , and the LS mean of the ratios in metformin AUC , AUC@-last and Cmax were close to unity , and the @ % CI of all these parameters fell within the predefined equivalence range of @-@ , confirming bioequivalence .


The metformin AUC was reduced by @ % and Cmax by @ % after acarbose + metformin compared with metformin alone .


Eight subjects ( @ % ) reported AEs , but all were mild , and most were gastrointestinal , as expected for these agents .


The incidence of AEs was not higher with the combinations vs. monotherapy .


These data demonstrate that the acarbose/metformin FDC is bioequivalent to the loose combination of these agents .


Although acarbose slightly reduced the bioavailability of metformin , the accumulated evidence of the efficacy of this combination implies that this is clinically irrelevant .


The observed AE profile was consistent with the established knowledge on the safety of the two drugs .


The purpose of this study was to assess the in vitro P@Y@ receptor inhibitory effects of cangrelor on platelets from patients on maintenance prasugrel therapy treated with @ reloading dose regimens .


Despite its more potent and rapid antiplatelet effects compared with clopidogrel , recent studies have shown variability in prasugrel-mediated P@Y@ receptor inhibition , particularly in high-risk settings .


Cangrelor is a potent intravenous P@Y@ receptor inhibitor .


A total of @ patients with coronary artery disease on maintenance prasugrel ( @ mg/day ) therapy were randomized to a @ - or @-mg reload of prasugrel .


The platelet reactivity index ( PRI ) , as assessed by whole-blood vasodilator-stimulated phosphoprotein , was measured with and without in vitro incubation of cangrelor ( @ nM ) at baseline , and at @ and @ h after reload .


In the absence of cangrelor , prasugrel reloading reduced PRI ( p < @ for both doses ) , although a @-mg reload had greater platelet inhibition compared with a @-mg reload at @ h ( p = @ ) .


Cangrelor was associated with a reduction in PRI values during the overall study time course in patients reloaded with @ mg ( p = @ ) and @ mg ( p < @ ) of prasugrel .


In patients reloaded with @ mg prasugrel , cangrelor decreased PRI at each time point ( baseline , p < @ ; @ h , p = @ ; @ h , p = @ ) .


In patients reloaded with @ mg prasugrel , cangrelor decreased PRI at baseline ( p < @ ) and @ h ( p = @ ) ; levels of platelet reactivity comparable to those achieved with cangrelor were observed only at @ h ( p = @ ) .


The intergroup comparisons with cangrelor were not significant at any time point .


In patients on maintenance prasugrel therapy exposed to a reloading dose ( @ or @ mg ) of prasugrel , in vitro cangrelor is associated with further platelet P@Y@ receptor inhibitory effects .


Point of care testing for C-reactive protein ( CRP ) has shown promise as a measure to reduce unnecessary antibiotic prescribing in respiratory tract infections ( RTI ) , but its use in primary care is still controversial .


We aimed to evaluate the effect of CRP testing on the prescription of antibiotics , referral for radiography , and the outcome of patients in general practice with acute cough/RTI .


An open-cluster randomized clinical trial was conducted , with CRP testing performed in the intervention group .


Antibiotic prescribing and referral for radiography were the main outcome measures .


A total of @ patients were included : @ in the intervention group and @ in the control group .


The two groups were similar in clinical characteristics .


In the intervention group , the antibiotic prescribing rate was @ % , which was significantly lower than that in the control group ( @ % ) ( P = @ ) .


Referral for chest X-ray was also significantly lower in the intervention group ( @ % ) than in the control group ( @ % ) ( P = @ ) .


The recovery rate , as recorded by the GPs , was @ % and @ % in the intervention and control groups , respectively .


The study showed that CRP testing in patients with acute cough/RTI may reduce antibiotic prescribing and referral for radiography , probably without compromising recovery .


This study tested the effect of beginning treatment with a speech-generating device ( SGD ) in the context of a blended , adaptive treatment design for improving spontaneous , communicative utterances in school-aged , minimally verbal children with autism .


A total of @ minimally verbal children with autism , aged @ to @ years , were randomized to a blended developmental/behavioral intervention ( JASP+EMT ) with or without the augmentation of a SGD for @ months with a @-month follow-up .


The intervention consisted of @ stages .


In stage @ , all children received @ sessions per week for @ months .


Stage @ intervention was adapted ( by increased sessions or adding the SGD ) based on the child 's early response .


The primary outcome was the total number of spontaneous communicative utterances ; secondary measures were the total number of novel words and total comments from a natural language sample .


Primary aim results found improvements in spontaneous communicative utterances , novel words , and comments that all favored the blended behavioral intervention that began by including an SGD ( JASP+EMT+SGD ) as opposed to spoken words alone ( JASP+EMT ) .


Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes .


Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel , blended intervention that focuses on joint engagement and play skills and incorporates an SGD .


Future studies should further explore the tailoring design used in this study to better understand children 's response to treatment .


Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language ( CCNIA ) ; http://clinicaltrials.gov/; NCT@ .