Granisetron was not effective in controlling gastroenteritis-related vomiting subsequent to discharge from ED .


It did not change the expected course of the illness .


Although many Latinos in the United States smoke , they receive assistance to quit less often than non-Latinos .


To address this disparity , we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment , when men 's partners were pregnant .


We compared two interventions : ( i ) written materials plus nicotine replacement therapy ( NRT ) to ( ii ) materials , NRT , and couple-based counseling that addressed smoking cessation and couples communication .


We recruited @ expectant fathers who smoked via their pregnant partners from county health departments .


Our primary outcome was @-day point prevalence smoking abstinence and was collected from November @ through April @ and analyzed in February @ .


We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy ( @ vs. @ , materials only vs. counseling , respectively ) and @ months after randomization ( postpartum : @ vs. @ ) .


We found high quit rates among nondaily smokers but no arm differences ( @ vs. @ in pregnancy and @ vs. @ postpartum ) .


Among daily smokers , we found lower quit rates with no arm differences but effects favoring the intervention arm ( @ vs. @ in pregnancy and @ vs. @ postpartum ) .


A less intensive intervention promoted cessation equal to more intensive counseling .


Postpartum might be a more powerful time to promote cessation among Latino men .


Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities .


With ageing , the ability to mobilize fat is reduced and this , coupled with gradual decrease in lean body mass ( LBM ) from lessened exercise , allows for an increased body fat percentage ( % BF ) .


Exercising is considered a key to maintaining an appropriate body mass ( BM ) , as it improves fat oxidation , while maintaining LBM .


Although the effects of endurance and/or resistance training on fat mass ( FM ) and LBM in the elderly have well been established , limited data are forthcoming regarding the effects of Pilates as a training modality on these variables in the elderly .


The present study was therefore conducted to determine the effects of a mat Pilates programme on body fat in elderly women .


Fifty sedentary , apparently healthy females aged @ years and older were randomly assigned a control ( CG , n = @ ) or an intervention ( IG , n = @ ) group .


The IG took part in an eight-week progressive mat Pilates exercise programme , three times weekly while the CG were instructed to maintain their normal daily activities throughout the eight-week experimental period .


All subjects underwent pre - and post-test in which FM and LBM were assessed .


Eight weeks of mat Pilates demonstrated a significant ( p @ ) decrease in % BF ( p = @ ) and FM ( p = @ ) , with a significant increase in LBM ( p = @ ) , while not showing any significant changes ( p @ ) in BM ( p = @ ) and BMI ( p = @ ) .


The CG , however , did not produce any significant ( p @ ) changes in any of the tested anthropometric variables ( BM : p = @ ; BMI : p = @ ; % BF : p = @ ; FM : p = @ and LBM : p = @ ) after completion of the eight-week Pilates programme .


An eight-week mat Pilates exercise programme may contradict or even reverse some of the most serious consequences of ageing associated with an increased fat mass and reduced lean body mass in elderly females .


From an orthopedic point of view , wearing conventional ready to wear shoes negatively affects the front transverse arch of the human foot by forcing it into an unnatural inverted position .


The aim of the present orthopedic application study was to conduct a standardized assessment of the biomechanical effect of a newly developed , longitudinally flexible and cross stable spring steel insole by means of pedobarographic measurements and by means of a supplementary questioning of the participants .


In order to do this a total of @ healthy adult participants were recruited in summer @ .


The randomized , blinded and controlled main study compared the cross stable insole made from spring steel with a flat , ordinary control insole made from ethylene vinyl acetate by means of pedobarographic in-shoe measurements at the forefoot .


Additionally , the subjectively perceived effect of the steel insole with respect to comfort , restricted mobility and pain was assessed in a randomized , blinded and controlled ancillary study , using a cross-over design .


Both the plantar peak pressure and the plantar force-time integral were significantly higher with the spring steel insole , especially in the central forefoot .


In the subsequent test phase lasting several weeks during which the participants were asked to wear the spring steel insole , they rarely complained about problems and in particular did not report negative effects regarding comfort , restricted mobility and pain compared to the ordinary control insoles .


The present study was conducted according to high methodological standards and proved for the first time that the tested spring steel insoles have a positive effect on the human forefoot .


The cross stability increases the pressure in the median ball area , prevents the unnatural inverted position of the forefoot and thus creating an effect which is comparable to walking barefoot .


As the participants did not judge this orthopedic effect of the cross stability as being uncomfortable , such an insole could be used a millionfold as a primary prevention in conventional shoes .


The standard recommended dose ( @ U/kg per hour ) of insulin in diabetic ketoacidosis ( DKA ) guidelines is not backed by strong clinical evidence .


Physiologic dose-effect studies have found that even lower doses could adequately normalize ketonemia and acidosis .


Lowering the insulin dose may be advantageous in the initial hours of therapy when a gradual decrease in glucose , electrolytes , and resultant osmolality is desired .


To compare the efficacy and safety of low-dose insulin against the standard dose in children with DKA .


This was a prospective , open-label randomized clinical trial conducted in the pediatric emergency department and intensive care unit of a tertiary care teaching hospital in northern India from November @ , @ , through December @ , @ .


A total of @ consecutive children @ years or younger with a diagnosis of DKA were randomized to low-dose ( n = @ ) and standard-dose ( n = @ ) groups .


Low-dose ( @ U/kg per hour ) vs standard-dose ( @ U/kg per hour ) insulin infusion .


The primary outcome was the rate of decrease in blood glucose until a level of @ mg/dL or less is reached ( to convert to millimoles per liter , multiply by @ ) .


The secondary outcomes included time to resolution of acidosis , episodes of treatment failures , and incidences of hypokalemia and hypoglycemia .


The mean ( SD ) rate of blood glucose decrease until a level of @ mg/dL or less is reached ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- mg/dL/h ) and the mean ( SD ) time taken to achieve this target ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- hours ) were similar in the low - and standard-dose groups , respectively .


Mean ( SD ) length of time to achieve resolution of acidosis ( low vs standard dose : @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- hours ; P = @ ) and rate of resolution of acidosis were also similar in the groups .


Hypokalemia was seen in @ children ( @ % ) receiving the standard dose vs @ ( @ % ) of those receiving the low dose ( P = @ ) ; the tendency was more pronounced in malnourished children ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Five children ( @ % ) and @ child ( @ % ) receiving standard - and low-dose infusion ( P = @ ) , respectively , developed hypoglycemia .


Treatment failure was rare and comparable .


One child in the standard-dose group developed cerebral edema , and no deaths occurred during the study period .


Low dose is noninferior to standard dose with respect to rate of blood glucose decrease and resolution of acidosis .


We advocate a superiority trial with a larger sample size before @ U/kg per hour replaces @ U/kg per hour in the practice recommendations .


Mosquito coils are the most commonly used household insecticidal product in the world with sales exceeding @ billion coils , used by two billion people worldwide annually .


Despite strong evidence that coils prevent mosquito bites a systematic review concluded that there is no evidence that burning mosquito coils prevents malaria acquisition .


Therefore , the current trial was designed to measure and compare prevention of malaria infection by mosquito coils or long-lasting insecticidal net ( LLIN ) or a combination of the two in Yunnan , China in the Greater Mekong sub-region .


A four-arm single blind household-randomized design was chosen as coils emanate insecticide throughout the household .


Households enrolled at baseline were randomly allocated by the lottery method to one of the four intervention arms : ( i ) nothing , ( ii ) @ % transfluthrin coils alone , ( iii ) deltamethrin long-lasting insecticide treated nets , ( LLINs ) alone or ( iv ) a combination of transfluthrin coils and deltamethrin LLINs .


All household members were recruited to the study , with only those households excluded with pregnant or breastfeeding mothers , members with chest complaints or allergies or members that regularly slept away from home .


The main outcome of interest was Plasmodium falciparum malaria prevalence detected by rapid diagnostic tests ( RDTs ) during six repeated monthly cross-sectional surveys .


The secondary outcome of interest was the effect on Plasmodium vivax prevalence detected in the same way .


A total of @,@ households were recruited into the study , comprising @,@ individuals The odds ratios of testing positive by RDT with P. falciparum or P. vivax were > @ % lower for all intervention arms compared with the control arm .


Coils alone provided @ % protection ( @ % CI : @ % -@ % ) , LLINs provided @ % protection ( @ % CI : @ % -@ % ) and the combination of coils and LLINs provided @ % protection ( @ % CI : @ % -@ % ) against P. falciparum compared with the control arm .


There was no statistically significant difference between the protective efficacies of the different interventions .


This is the first robust clinical evaluation of transfluthrin mosquito coils as a means to reduce malaria and the high degree of infection prevented would indicate they represent a potentially highly effective tool , which could be integrated into larger vector control programmes .


Postoperative gastrointestinal dysfunction ( PGD ) is one of the most common complications following major surgeries under general anesthesia ( GA ) .


Despite ongoing research and new drug treatments , abdominal distension within @ h postoperatively occurs in @ % -@ % of all surgeries .


We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan ( PC@ ) , Zusanli ( ST@ ) and Shangjuxu ( ST@ ) bilaterally twice a day compared with sham-acupuncture treatment and standard treatment .


This is a single-center , prospective practical randomized controlled trial .


All groups will be given standard treatments .


Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University , China , and divided into three groups .


The experimental group will receive routine treatments and acupuncture at PC@ , ST@ and ST@ bilaterally with electrical stimulation twice a day for @ min preoperatively .


The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC@ , ST@ and ST@ , which are @ cun away from the real acupoints .


The routine-treatment group will not receive electroacupuncture .


The outcomes include the incidence of abdominal distention , abdominal circumference , the degree of abdominal distension , the first time of flatus and defecation , and hospitalization duration .


The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. .


This study may also provide a standardized acupuncture treatment for reduction of PGD .


Factors influencing prostate-specific antigen ( PSA ) changes in men undergoing testosterone ( T ) therapy have not been well studied .


The aim of this study was to assess the influence of selected variables on PSA changes in hypogonadal men administered with @ % testosterone gel ( T-gel ) for @ months .


A double-blind , placebo-controlled study of @ ( @ T-gel , @ placebo ) hypogonadal men > @ years of age , with baseline T concentrations < @ng/dL , PSA@ @ ng/mL , and negative digital rectal examination .


Subjects received once-daily T-gel for T therapy .


Changes in mean serum PSA , percentage of free PSA ( % fPSA ) , and T from baseline to @ months ( @ days ) .


Mean age was @ years and baseline mean values were total T @ng/dL , PSA @ ng/mL , and % fPSA @ % .


Among men treated with T-gel , T increased to @ng/dL and PSA increased by @ ng/mL ( P = @ ) .


PSA increased @ ng/mL in @ % , < @ ng/mL in @ % , including a decline from baseline in @ % .


In the placebo group , T increased @ng/dL to @ng/dL , and PSA decreased @ ng/mL , compared with baseline .


A greater increase in PSA was noted in men @ years old than in men < @ years old ( @ vs. @ ng/mL , respectively ; P = @ ) .


Mean PSA did not change in men with baseline serum T > @ng/dL , whereas it increased by @ ng/mL in men with T@ng/dL ( P = @ ) .


PSA increased @ ng/mL in men with baseline % fPSA < @ % and @ ng/mL in men with % fPSA@ % .


Overall , T-gel treatment was associated with a minor increase in PSA , of questionable clinical significance .


Factors predicting greater PSA increases included age @ years , baseline T@ng/dL , and % fPSA < @ % .


Men with T > @ng/dL and age < @ years demonstrated minimal or no PSA change .


The objective of the current study was to compare surgeon-rated visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine .


Eighty-three patients were randomized to receive irrigation fluid with ( @ patients ) or without ( @ patients ) epinephrine during their arthroscopic shoulder procedures .


After each procedure , the blinded senior author ( G.F.C. ) evaluated visualization based on a visual analog scale ( VAS ) , and all clinically important procedure variables were recorded .


Eighty-three arthroscopic shoulder procedures were included in the study .


Fifty-four of these procedures were arthroscopic rotator cuff repairs , allowing a subset analysis of this specific procedure .


There was a significant difference , with improved visualization in the epinephrine group versus the group without epinephrine when comparing all procedures ( P < @ ) and when comparing only rotator cuff repairs ( P < @ ) .


However , there was no statistical difference in other clinically important variables , including operative time and amount of irrigation fluid used .


The addition of epinephrine to irrigation fluid significantly improves surgeon-rated visualization in shoulder arthroscopy .


Without an observed significant difference in operative time or volume of irrigation fluid used , the clinical significance of this improved visualization is unclear , and the use of irrigation fluid without epinephrine remains a viable option in the hands of an experienced surgeon .


Level I , high-quality randomized controlled trial with statistically significant difference .


After percutaneous coronary intervention ( PCI ) for non-ST-segment elevation myocardial infarction ( NSTEMI ) , treatment with a P@Y@ antagonist with aspirin is recommended for @ year .


The oral P@Y@ antagonists ticagrelor and prasugrel have higher recommendations than clopidogrel , but it is unknown if administration before the start of PCI is beneficial .


In the randomized , double-blind ACCOAST ( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction ) trial , @,@ patients were diagnosed with NSTEMI and @ % underwent PCI ; @,@ received pre-treatment with prasugrel ( @-mg loading dose ) , and @,@ received placebo .


At the time of PCI , patients who received pre-treatment with prasugrel received an additional @-mg dose of prasugrel , and those who received placebo received a @-mg loading dose of prasugrel .


Primary efficacy was a composite of cardiovascular death , myocardial infarction , stroke , urgent revascularization , or glycoprotein IIb/IIIa bailout through @ days from randomization .


Investigators captured the presence of thrombus on initial angiography and during PCI .


The incidence of the primary endpoint through @ days from randomization in the pre-treatment group versus the no pre-treatment group was @ % versus @ % ( p = @ ) .


Pre-treatment with prasugrel was not associated with decreases in any ischemic event , including total mortality .


Patients with thrombus on angiography had a @-fold higher incidence of the primary endpoint than patients without thrombus .


There was no impact of pre-treatment with prasugrel on the presence of thrombus before PCI or on occurrence of stent thrombosis after PCI .


There was a @-fold increase in all non-coronary artery bypass graft Thrombolysis In Myocardial Infarction ( TIMI ) major bleeding and a @-fold increase in non-coronary artery bypass graft life-threatening bleeding with pre-treatment with prasugrel ; the same trends persisted in patients who had radial or femoral access even with use of a closure device .


These findings support deferring treatment with prasugrel until a decision is made about revascularization in patients with NSTEMI undergoing angiography within @ h of admission .


( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction -LSB- ACCOAST -RSB- ; NCT@ ) .


High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex ( rTMS-DLPFC ) is an effective treatment for depression .


Preliminary studies indicated beneficial effects of rTMS-DLPFC on pain relief in patients treated for depression , and in patients with chronic migraine .


In this randomized , double-blind , parallel-group , single-center , proof-of-principle clinical trial , we tested the hypothesis that @ sessions of active rTMS-DLPFC delivered over eight weeks would be feasible , safe and superior to sham rTMS to decrease the number of headache days in @ patients with chronic migraine without severe depression .


Per-protocol analysis was performed .


rTMS-DLPFC applied over eight weeks was feasible and safe in patients with chronic migraine .


Contrary to our primary hypothesis , the number of headache days decreased significantly more in the sham group than in the group treated with active rTMS-DLPFC at eight weeks .


Average decrease in headache days was > @ % in the sham group , indicating a powerful placebo response .


Pain intensity improved in both groups to a similar extent .


Positive results of M@ stimulation in other studies , and the absence of significant benefits of active high-frequency rTMS of the DLPFC in the present study , point to M@ as a more promising target than the DLPFC , for larger trials of noninvasive brain stimulation in patients with chronic migraine .


Colorectal cancer ( CRC ) is the second most prevalent type of cancer in Europe .


A single flexible sigmoidoscopy ( FS ) screening at around the age of @ years prevents about one-third of CRC cases .


However , FS screens only the distal colon , and thus mortality from proximal CRC is unaffected .


Computed tomography colonography ( CTC ) is a highly accurate examination that allows assessment of the entire colon .


However , the benefit of CTC testing as a CRC screening test is uncertain .


We designed a randomized trial to compare participation rate , detection rates , and costs between CTC ( with computer-aided detection ) and FS as primary tests for population-based screening .


An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of @,@ people aged @ or @ years , living in the Piedmont region and the Verona district of Italy .


Individuals with a history of CRC , adenomas , inflammatory bowel disease , or recent colonoscopy , or with two first-degree relatives with CRC will be excluded from the study by their general practitioners .


Individuals responding positively to the invitation letter will be then randomized to the intervention group ( CTC ) or control group ( FS ) , and scheduled for the screening procedure .


The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests .


Secondary outcomes are cost-effectiveness analysis , referral rates for colonoscopy induced by CTC versus FS , and the expected and perceived burden of the procedures .


To compare participation rates for CTC versus FS , @,@ additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS .


In the CTC arm , non-responders will be offered fecal occult blood test ( FOBT ) as alternative screening test , while in the FS arm , non-responders will receive an invitation letter to undergo screening with either FOBT or CTC .


Data on reasons for participation and non-participation will also be collected .


This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS .


The trial will also evaluate the role of computer-aided detection in a screening setting .


Awake regional anesthesia ( RA ) is a viable alternative to general anesthesia ( GA ) for infants undergoing lower abdominal surgery .


Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes .


The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants .


The aim of the study is to describe success and failure rates of RA and report factors associated with failure .


This was a nested cohort study within a prospective , randomized , controlled , observer-blind , equivalence trial .


Seven hundred twenty-two infants @ weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA ( spinal , caudal epidural , or combined spinal caudal anesthetic ) or GA with sevoflurane .


The data of @ infants , where spinal or combined spinal caudal anesthetic was attempted , were analyzed .


Possible predictors of failure were assessed including patient factors , technique , experience of site and anesthetist , and type of local anesthetic .


RA was sufficient for the completion of surgery in @ % of patients .


Spinal anesthesia was successful in @ % of cases and combined spinal caudal anesthetic in @ % .


Thirty-four patients required conversion to GA , and an additional @ patients ( @ % ) required brief sedation .


Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure ( odds ratio = @ ) .


The failure rate of spinal anesthesia was low .


Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone .


To compare a multicomponent motivational interviewing ( MI ) / self-management ( SM ) intervention with a multicomponent education intervention to improve skin-protective behaviors and prevent skin worsening in veterans with spinal cord injury ( SCI ) hospitalized for severe pressure ulcers ( PrUs ) .


Single-blinded , prospective , randomized controlled trial .


Six Veterans Affairs SCI centers .


Veterans admitted for a severe ( stage III/IV ) PrU were followed up to @ months postdischarge .


Telephone-based individual MI counseling plus SM skills group ( SM+MI ; n = @ ) versus an active control group of telephone-based individual educational counseling plus group education ( n = @ ) .


Self-reported skin-protective behaviors , objective skin worsening .


Intention-to-treat analyses found nonsignificant increases in skin behaviors in the SM+MI versus education control intervention arms at @ and @ months .


The difference in behaviors used between SM+MI and education control intervention participants was @ % ( @ % confidence interval -LSB- CI -RSB- , -@ to @ ) ( @-@mo ) and @ % ( @ % CI , -@ to @ ) ( @-@mo ) .


High rates of skin worsening were observed ( n = @ , @ % ) , usually within @ months postdischarge and most frequently within the month postdischarge .


Skin worsening , skin-related visits , and readmissions did not differ by study arm .


Study limitations are presented .


For persons with chronic SCI and severe PrUs , complicated by multiple comorbidities , a primary focus on improving patient behavior is likely insufficient to address the complex problem of PrUs in SCI .


More health care systems-level changes such as collaborative care may be needed to reduce PrU recurrence , especially in this era in which many people are discharged from the hospital unhealed or with little sitting tolerance .


Orteronel is an investigational , partially selective inhibitor of CYP @,@-lyase in the androgen signalling pathway , a validated therapeutic target for metastatic castration-resistant prostate cancer .


We assessed orteronel in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .


In this phase @ , double-blind , placebo-controlled trial , we recruited patients with progressive metastatic castration-resistant prostate cancer and no previous chemotherapy from @ study centres ( ie , hospitals or large urologic or group outpatient offices ) in @ countries .


Eligible patients were randomly assigned in a @:@ ratio to receive either @ mg orteronel plus @ mg prednisone twice daily or placebo plus @ mg prednisone twice daily .


Randomisation was done centrally with an interactive voice response system and patients were stratified by region ( Europe , North America , and not Europe or North America ) and the presence or absence of radiographic disease progression at baseline .


The two primary endpoints were radiographic progression-free survival and overall survival , determined in the intention-to-treat population .


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


From Oct @ , @ , to June @ , @ , @ patients were assessed for eligibility .


Of those , @ were randomly assigned to receive either orteronel plus prednisone ( n = @ ) or placebo plus prednisone ( n = @ ) .


The clinical cutoff date for the final analysis was Jan @ , @ ( with @ deaths ) .


Median follow-up for radiographic progression-free survival was @ months ( IQR @-@ ) .


Median radiographic progression-free survival was @ months ( @ % CI @-@ ) with orteronel plus prednisone and @ months ( @-@ ) with placebo plus prednisone ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p < @ ) .


After a median follow-up of @ months ( IQR @-@ ) , median overall survival was @ months ( @ % CI @-not estimable ) with orteronel plus prednisone and @ months ( @-not estimable ) with placebo plus prednisone ( HR @ , @ % CI @-@ ; p = @ ) .


The most common grade @ or worse adverse events were increased lipase ( @ -LSB- @ % -RSB- of @ patients in the orteronel plus prednisone group vs @ -LSB- @ % -RSB- of @ patients in the placebo plus prednisone group ) , increased amylase ( @ -LSB- @ % -RSB- vs nine -LSB- @ % -RSB- ) , fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and pulmonary embolism ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Serious adverse events were reported in @ -LSB- @ % -RSB- patients receiving orteronel plus prednisone and in @ -LSB- @ % -RSB- patients receiving placebo plus prednisone .


In chemotherapy-naive patients with metastatic castration-resistant prostate cancer , radiographic progression-free survival was prolonged with orteronel plus prednisone versus placebo plus prednisone .


However , no improvement was noted in the other primary endpoint , overall survival .


Orteronel plus prednisone was associated with increased toxic effects compared with placebo plus prednisone .


On the basis of these and other data , orteronel is not undergoing further development in metastatic castration-resistant prostate cancer .


Vortioxetine is a recently approved multimodal antidepressant with anxiolytic properties in preclinical studies .


This double-blind , placebo-controlled study assessed the efficacy and tolerability of vortioxetine in subjects with a primary diagnosis of generalized anxiety disorder .


Subjects ( n = @ ) were randomized @:@:@ to treatment with placebo or vortioxetine @ or @mg once daily .


The primary efficacy endpoint was reduction in Hamilton Anxiety Scale ( HAM-A ) total scores from baseline after @weeks of treatment .


Key secondary outcomes were changes from baseline in HAM-A total scores for the @ and @mg dose , Hospital Anxiety and Depression anxiety subscore , @-Item Short-Form Health Survey , Sheehan Disability Scale , and Clinical Global Impression-Improvement Scale score , as well as HAM-A response rate at week @ .


Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint ( least-squares mean differencestandard error from placebo : -@ -LSB- p = @ -RSB- for @ mg and -@ -LSB- p = @ -RSB- for @mg vortioxetine ) or on any secondary efficacy endpoints .


Common adverse events ( @ % in either vortioxetine group ) were nausea , dry mouth , headache , diarrhea , constipation , and vomiting .


Vortioxetine @ and @mg treatment did not significantly improve generalized anxiety disorder symptoms versus placebo .


Vortioxetine was safe and well tolerated in this patient population .


In acute stroke , the volume of salvageable brain tissue is maximal at onset and declines rapidly with time .


Prehospital start of clinical trial interventions would enable delivery of neuroprotective agents , such as magnesium sulfate , to stroke patients in the hyperacute period when they are potentially most effective .


A broad aim of the FAST-MAG study is to develop and validate techniques to perform pivotal trials of neuroprotective therapies for acute stroke in the prehospital setting .


In tandem with an accompanying general trial design article , this manuscript provides a detailed overview of several novel prehospital study methods employed in the NIH FAST-MAG Trial .


Multicenter , randomized , double-blinded , placebo-controlled , pivotal clinical trial .


Special Prehospital Procedures Distinctive prehospital methods deployed in FAST-MAG include : identifying likely stroke patients using the Los Angeles Prehospital Stroke Screen ; eliciting explicit informed consent from patients or on scene legally authorized representatives via cellphone discussion with off-scene physicians ; paramedic rating of pretreatment stroke severity using the Los Angeles Motor Scale ; assigning patients to a study arm using blinded , pre-encounter randomization ; facilitating continuity of study infusion from the field to the ED by stocking ambulances with study kits including both field and hospital doses ; and electronic fax consent signature documentation by geographically separated subjects and enrolling physicians .


The suite of prehospital trial methods developed for the FAST-MAG Trial enable enrollment of patients in very early time windows , including the hyperacute , ` golden hour ' period immediately after stroke onset .


The development of periarticular thickening of skin on the hands and limited joint mobility ( cheiroarthropathy ) is associated with diabetes and can lead to significant disability .


The objective of this study was to describe the prevalence of cheiroarthropathy in the well-characterized Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications ( DCCT/EDIC ) cohort and examine associated risk factors , microvascular complications , and the effect of former DCCT therapy ( intensive -LSB- INT -RSB- vs. conventional -LSB- CONV -RSB- ) on its development .


This cross-sectional analysis was performed in @,@ participants ( @ % of the active cohort ) in EDIC years @/@ after an average of @ years of follow-up .


Cheiroarthropathy-defined as the presence of any one of the following : adhesive capsulitis , carpal tunnel syndrome , flexor tenosynovitis , Dupuytren 's contracture , or a positive prayer sign-was assessed using a targeted medical history and standardized physical examination .


A self-administered questionnaire ( Disabilities of the Arm , Shoulder and Hand -LSB- DASH -RSB- ) assessed functional disability .


Cheiroarthropathy was present in @ % of subjects ( @ % of the INT group and @ % of the CONV group ; P = @ ) and was associated with age , sex , diabetes duration , skin intrinsic fluorescence , HbA@c , neuropathy , and retinopathy ( P < @ for each ) .


DASH functional disability scores were worse among subjects with cheiroarthropathy ( P < @ ) .


Cheiroarthropathy is common in people with type @ diabetes of long duration ( @ years ) and is related to longer duration and higher levels of glycemia .


Clinicians should include cheiroarthropathy in their routine history and physical examination of patients with type @ diabetes because it causes clinically significant functional disability .


The present research examined the effects of a mindfulness-based intervention to foster healthy eating .


Specifically , we tested whether a brief mindfulness manipulation can prevent the portion size effect , and reduce overeating on unhealthy snacks when hungry .


@ undergraduate participants ( MAge = @ ; MBMI = @ ) were served a small or a large portion of chocolate chip cookies after listening to an audio book or performing a mindfulness exercise ( i.e. , body scan ) .


Current level of hunger was assessed unobtrusively on a visual analog scale before the eating situation .


Calorie intake from chocolate chip cookies .


When presented with a large compared to a small portion , participants consumed more cookies ( +@ kcal ) .


This was not affected by the mindfulness intervention or by hunger .


However , while control participants ate more unhealthy food when hungry than when not hungry ( +@ kcal ) , participants in the mindfulness condition did not ( +@ kcal ) .


Findings confirm the prevalence and robustness of the portion size effect and suggest that it may be independent from awareness of internal cues .


Prevention strategies may benefit more from targeting awareness of the external environment .


However , mindfulness-based interventions may be effective to reduce effects of hunger on unhealthy food consumption .


This study aimed to investigate the potential use of icotinib as first-line treatment to prevent brain metastasis from advanced lung adenocarcinoma .


This investigation was designed as a retrospective nonrandomized controlled study .


Enrolled patients received either icotinib or traditional chemotherapy as their first-line treatment .


The therapeutic efficacy was compared among patients with advanced ( stages IIIB and IV ) lung adenocarcinoma with epidermal growth factor receptor ( EGFR ) - sensitive mutation .


The primary endpoint was the cumulative incidence of brain metastasis , whereas the secondary endpoint was overall survival ( OS ) .


Death without brain metastasis was considered a competitive risk to calculate the cumulative risk of brain metastasis .


Survival analysis was conducted using the Kaplan-Meier method and statistical significance were determined using the log-rank test .


The present study included @ patients with @ in the icotinib group and @ in the chemotherapy group .


Among those with EGFR-sensitive mutation , the cumulative risk of brain metastasis was lower in the icotinib group than in the chemotherapy group .


However , no significant difference in OS was observed between the two groups .


Icotinib can effectively reduce the incidence of brain metastasis and therefore improve prognosis in advanced lung adenocarcinoma patients with EGFR-sensitive mutation .


Many people with suicidal thoughts do not receive treatment .


The Internet can be used to reach more people in need of support .


To test the effectiveness of unguided online self-help to reduce suicidal thoughts .


@ adults with mild to moderate suicidal thoughts were randomised to the intervention ( n = @ ) or a waitlist control group ( n = @ ) .


Assessments took place at baseline , and @ , @ and @ weeks later .


Primary outcome was suicidal thoughts .


Secondary outcomes were depressive symptoms , anxiety , hopelessness , worry , and health status .


The intervention group showed a small significant effect in reducing suicidal thoughts ( d = @ ) .


Effects were more pronounced for those with a history of repeated suicide attempts .


There was also a significant reduction in worry ( d = @ ) .


All other secondary outcomes showed small but non-significant improvements .


Although effect sizes were small , the reach of the internet could enable this intervention to help many people reduce their suicidal thoughts .


Matrix metalloproteinase-@ and -@ , known as gelatinases , are considered to be essential for tissue remodelling during the reproductive process .


However , their role in reproduction is unclear .


In the present study , we aimed to investigate the relationship between follicular fluid gelatinase levels and oocyte quality and fertilization , and to compare the activities of gelatinase levels with different drug stimulation protocols .


We evaluated @ women with unexplained infertility who underwent in vitro fertilization ( IVF ) treatment .


Thirty patients underwent a gonadotropin-releasing hormone ( GnRH ) agonist protocol and @ underwent a GnRH antagonist protocol .


Follicular fluid was obtained during oocyte retrieval .


Oocyte quality was determined using light microscopy , and oocytes were considered to be fertilized when two pronuclei were present .


Gelatinase activities were measured using commercial enzyme-linked immunosorbent assay kits .


The study was partially supported by the Scientific Research Unit of Suleyman Demirel University ( Protocol Number : @-TU@-@ ) , and all procedures were conducted with the approval of the Suleyman Demirel University Local Ethics Board .


Statistical analyses of the data were performed using the independent t test , Fisher exact test , Mann-Whitney U test , one-way ANOVA , and posthoc least significant difference .


Follicular fluid gelatinase levels were significantly higher for agonist drug administration ( p = @ ) , and a positive correlation was observed between matrix metalloproteinase-@ levels and oocyte grade ( p = @ ) .


Moreover , a positive relationship between matrix metalloproteinase-@ levels and fertilization was observed ( p = @ ) .


Follicular fluid gelatinase activities , particularly MMP-@ activity , might be a predictor of oocyte quality and IVF success .


Remifentanil is an ultrashort-acting synthetic opioid , and the metabolism of which is not influenced by hepatic or renal function .


This study aims to compare the efficacy of two remifentanil doses during procedures in ventilated preterm infants .


Prospective , randomized , double-blind , noninferiority trial .


Neonatal ICU .


Preterm infants who were supported by a mechanical ventilator with tracheal tube and requiring central venous access .


Two remifentanil dosages were administered in mechanically ventilated preterm infants during peripherally inserted central catheter insertion .


Fourteen preterm infants were randomly assigned to low-dose ( @ g/kg/min ) or high-dose ( @ g/kg/min ) remifentanil infusion .


The Premature Infant Pain Profile was used to score pain during the procedure , and changes in the Premature Infant Pain Profile score between needle puncture and baseline were analyzed to investigate the noninferiority of low-dose to high-dose remifentanil .


Occurrence of cardiorespiratory complications was also recorded .


The median gestational age ( minimum , maximum ) was @ weeks ( @ , @ ) , and the median birth weight was @ g ( @ , @,@ ) .


Changes in Premature Infant Pain Profile in the high-dose and low-dose groups were @ @ and -@ @ , respectively .


The difference in changes in the Premature Infant Pain Profile score between the high-dose and low-dose groups was -@ @ .


The corresponding lower limit of one-tailed @ % CI was -@ , below the noninferiority margin .


Apneic events and bradycardia did not occur in the low-dose group ; however , there were three episodes of apnea ( @ % ) and one of bradycardia ( @ % ) in the high-dose group ( p = @ and @ , respectively ) .


For mechanically ventilated preterm infants , the use of remifentanil at @ g/kg/min as an analgesic for short procedures represents a therapeutic option .


Our pilot study suggests the need for larger randomized trials .


The objective of this study was to compare two different periodontal plastic surgery procedures to treat Miller 's class I recession : a coronally advanced flap ( control group ) versus the pouch technique ( test group ) , both of which were associated with connective tissue graft .


Forty consecutive patients were included , with @ patients being allocated for each group .


The level of recession coverage , the keratinized tissue ( KT ) quantity , gingival aesthetics ( PES ) and post-operative outcomes were assessed for a follow-up period of @ months .


After @ months , both techniques allowed for the excellent mean root coverage of @ plus/minus @ % in the control group and of @ plus/minus @ % in the test group.Complete root coverage was achieved in @ % ( @/@ ) and @ % ( @/@ ) of the recession cases in the control and the test groups respectively .


A significant increase in KT height ( p = @ ) was observed in the test group .


A significant improvement in the pink aesthetic score was found in the two groups , but gingival texture displayed significantly better results in the test group ( p < @ ) .


No significant difference between the two groups was found in terms of the morbidity outcomes .


Pain killer consumption was similar in the two groups and significantly decreased over time .


Both surgical techniques are relevant in treating Miller 's class I recession .


The pouch technique seems to increase the height of KT better and provides good gingival-related aesthetic outcomes .


To explore the effects and mechanism of acupuncture at Zusanli ( ST @ ) combined with oral administration of Gexia Zhuyu decoction on damp-heat ulcerative colitis at active phase .


One hundred and twenty cases of damp-heat ulcerative colitis at active phase , by using random draw method , were divided into an observation group and a control group , @ cases in each one .


Patients in the control group were treated with basic treatment combined with oral administration of Gexia Zhuyu decoction .


Based on this , patients in the observation group were additionally treated with acupuncture at Zusanli ( ST @ ) .


The treatment was given both for @ days .


The efficacy , each symptom score , serum interleukin-@beta ( IL-@beta ) , interleukin-@ ( IL-@ ) and tumor necrosis factor-alpha ( TNF-alpha ) were observed .


( @ ) After treatment , the total effective rate was @ % ( @/@ ) in the observation group , which was significantly higher than @ % ( @/@ ) in the control group ( P < @ ) .


( The improvement rates of ulceration , edema , erosion and polyp in the observation group were obviously higher than those in the control group ( all P < @ ) .


( @ ) After treatment , the symptom scores of diarrhea , bloody purulent stool , abdominal pain , tenesmus as well as inflammatory factors of IL-@beta , IL-@ and TNF-alpha were all improved compared with those before treatment in the two groups ( all P < @ ) ; the differences between the observation , group and control group were statistically significant ( all P < @ ) .


( @ ) During the @-month follow up visit , the recurrence rate was @ % ( @/@ ) in the observation group , which was significantly lower than @ % ( @/@ ) in the control group ( P < @ ) .


The Gexia Zhuyu decoction combined with acupuncture at Zusanli ( ST @ ) could effectively improve efficacy , reduce recurrence rate , relieve clinical symptoms and prompt recovery of mucous membrane in patients with damp-heat ulcerative colitis at active phase , which is related with reducing the expression of inflammation .


To compare the incidence and intensity of posterior capsule opacification ( PCO ) between @ similar @-piece foldable hydrophobic acrylic intraocular lenses ( IOLs ) over @ years .


Department of Ophthalmology , Medical University Vienna , Vienna , Austria .


Randomized prospective patient - and examiner-masked clinical trial with intraindividual comparison .


Patients with bilateral age-related cataract had cataract surgery and implantation of a Tecnis ZCB@ continuous-optic-edge IOL in @ eye and an Acrysof SA@AT interrupted-optic-edge IOL in the other eye .


Postoperative examinations were performed at @ months and @ years .


Digital retroillumination images were taken of each eye .


The amount of PCO ( score @ to @ ) was assessed subjectively at the slitlamp and objectively using automated image-analysis software .


The study comprised @ patients ( @ eyes ) .


The mean objective PCO score was @ @ ( SD ) for the continuous-optic-edge IOLs and @ @ for the interrupted-optic-edge IOLs ( P = @ ) .


Three years postoperatively , a neodymium : YAG ( Nd : YAG ) capsulotomy was performed in @ % of eyes with the continuous-optic-edge IOL and @ % with the interrupted-optic-edge IOL ( P = @ ) .


There was no significant difference in corrected distance visual acuity , capsulorhexisIOL overlap , capsule folds , or anterior capsule opacification @ years after surgery .


Both IOLs had comparable PCO and Nd : YAG rates @ years postoperatively .


The optimized barrier function of the continuous-optic-edge IOL and the material properties of the interrupted-optic-edge IOL seemingly outbalanced the effect on lens epithelial cell migration and proliferation beneath the optic .


To use a cine balanced steady-state free precession magnetic resonance enterography ( cine MRE ) pulse sequence to assess the effectiveness of a sublingual ( SL ) antiperistaltic agent , hyoscyamine sulfate .


Institutional review board approval was granted with an exemption for informed consent in this Health Insurance Portability and Accountability Act-compliant , retrospective , single-institution study .


Of the @MRE examinations performed between October @ , @ and January @ , @ , @ using SL hyoscyamine sulfate for antiperistalsis were included for review , each with cine MRE before and after medication .


These @ cine MRE data sets were randomized , blinded for treatment , and independently reviewed by five attending abdominal radiologists , who rated the degree of whole abdomen bowel motility on each cine MRE data set on a @-point scale .


Pre - and postmedication mean peristalsis ratings , standard deviation , mean difference , and treatment effect sizes werecalculated .


A repeated measures analysis of variance test was performed using a significance threshold of P = @ .


Interobserver reliabilities were also calculated .


Mean peristalsis ratings ranged @-@ @ and @-@ @ , before and after medication administration , respectively .


The mean differences ranged from @ to @ , which are treatment effect sizes of @ to @ .


The decrease in peristalsis observed by the five reviewing radiologists after SL hyoscyamine sulfate administration was significant ( df = @/@ , f = @ , P < @ ) .


The interobserver reliabilities were @ for the pretest and @ for the posttest .


Although cine MRE sequences show decreased bowel peristalsis after the use of SL hyoscyamine sulfate , the small size ofthe observed treatment effect is likely insufficient to justify its use for MRE .


CONCERTO was a randomised , double-blind , parallel-armed study of methotrexate ( MTX ) in combination with adalimumab to assess whether an increasing trend of efficacy and decreased safety exists when increasing MTX dose in patients with early rheumatoid arthritis ( RA ) .


Early , biologic and MTX-naive RA patients ( N = @ ) were evenly randomised to open-label adalimumab ( @mg every other week ) plus weekly blinded @ , @ , @ or @mg MTX for @weeks .


Clinical , radiographic and functional outcomes were analysed using two-sided linear trend tests or one-way analysis of covariance .


Statistically significant increasing trends were observed in the proportion of patients achieving the primary endpoint , @-joint count disease activity score with C reactive protein ( DAS@ ( CRP ) ) < @ ( @ % , @ % , @ % and @ % for @ , @ , @ or @mg/week MTX , respectively ) , DAS@ ( CRP ) < @ and American College of Rheumatology @/@/@ responses with increasing doses of MTX in combination with adalimumab .


No statistical differences in minimal clinically important differences in physical function were detected .


Statistically significant trends for achieving low disease activity and remission were demonstrated with increasing MTX dose by validated clinical indices ; differences comparing @ and @mg MTX were minimal .


Adalimumab serum concentrations increased with ascending dose up to @mg MTX .


More patients experienced infectious adverse events with increasing MTX dose .


Increasing doses of MTX in combination with adalimumab demonstrated a statistically significant trend in improved clinical outcomes that mimicked the adalimumab pharmacokinetic profile .


In early RA patients initiating adalimumab combination therapy , efficacy of @ and @mg/week MTX appeared equivalent .


To compare transvaginal prolapse repair combined with midurethral sling ( MUS ) versus prolapse repair only .


Multi-centre randomised trial .


Fourteen teaching hospitals in the Netherlands .


Women with symptomatic stage two or greater pelvic organ prolapse ( POP ) , and subjective or objective stress urinary incontinence ( SUI ) without prolapse reduction .


Women were randomly assigned to undergo vaginal prolapse repair with or without MUS .


Analysis was according to intention to treat .


The primary outcome at @ months ' follow-up was the absence of urinary incontinence ( UI ) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder .


Secondary outcomes included complications .


One hundred and thirty-four women were analysed at @ months ' follow-up ( @ in MUS and @ in control group ) .


More women in the MUS group reported the absence of UI and SUI ; respectively @ % versus @ % UI ( relative risk -LSB- RR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ) and @ % versus @ % SUI ( RR @ ; @ % CI @-@ @ ) .


Fewer women underwent treatment for postoperative SUI in the MUS group ( @ % versus @ % ; RR @ ; @ % CI @-@ @ ) .


In the control group , @ women ( @ % ) underwent MUS after prolapse surgery versus none in the MUS group .


Severe complications were more common in the MUS group , but the difference was not statistically significant ( @ % versus @ % ; RR @ ; @ % CI @-@ @ ) .


Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only .


However , only @ % of the women undergoing POP surgery needed additional MUS .


A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women .


To compare the postprandial plasma glucose level after diabetic specific formula ( DSF ) and standard formula ( SF ) administration in type @ diabetic patients .


Thirty type @ diabetic patients were included in the present randomized , controlled , double-blind , cross-over study .


Subjects received DSF and isocaloric SF as a bolus administration of @ mL while continuing their anti-diabetic medications .


Venous blood samples were collected and analyzed to assess plasma glucose levels at pre - and at @ , @ , @ , @ , and @ min post-administration of the formulas .


Postprandial glucose profiles were significantly lower with DSF compared to SF administration determined as a mean glucose concentration at @-hour post-administration .


The glucose area under the curve ( AUC ) after DSF consumption was @ % lower than the AUC after SF consumption , p < @ .


Use of DSF resulted in a significantly lower postprandial rise in plasma glucose concentrations than using SF .


It should be the preferred option in diabetic patients who need nutritional support .


Irisin is a recently identified exercise-induced myokine .


However , the circulating levels of irisin in response to different types of exercise in subjects with metabolic syndrome are unknown .


This study aimed to study the levels of irisin in healthy males and subjects with metabolic syndrome at baseline and in response to exercise .


Each individual completed high-intensity interval exercise ( HIIE ) , continuous moderate-intensity exercise ( CME ) , and resistance exercise ( RE ) sessions in a random , crossover design .


Percentage change in circulating irisin levels was examined .


Two different irisin assays were used to compare the results of the RE study .


Circulating irisin increased immediately after HIIE , CME , and RE and declined @ hour later .


The increase was greater in response to resistance compared with either high-intensity intermittent exercise or CME .


Change in irisin in response to exercise did not differ between individuals with and without metabolic syndrome .


Exercise is able to increase circulating irisin levels in individuals with the metabolic syndrome as well as healthy individuals .


Whether this increase may contribute to the beneficial effects of exercise on patients with the metabolic syndrome remains to be studied further .


Blacks receive live donor kidney transplant ( LDKT ) less often than patients of all other races .


We evaluated the effectiveness of educational interventions in removing barriers to LDKT for blacks .


Patients were randomized to three interventions in which health educator ( s ) delivered an intervention to ( a ) the patient and his/her guests in the patient 's home ( house calls -LSB- HC -RSB- , n = @ ) , ( b ) clusters of patients and their guests in the transplant center ( group based -LSB- GB -RSB- , n = @ ) , and ( c ) the individual patient alone in the transplant center ( individual counseling -LSB- IC -RSB- , n = @ ) .


At the @-year endpoint , @ % ( n = @ ) , @ % ( n = @ ) , and @ % ( n = @ ) of HC , GB , and IC patients , respectively , received LDKT ( P = @ ) .


Patients in the HC group were more likely than patients in the GB and IC groups to have at least one donor inquiry ( @ % vs. @ % vs. @ % , P = @ ) and evaluation ( @ % vs. @ % vs. @ % , P < @ ) .


Patients in the HC group also were more likely to have higher knowledge , fewer concerns , and higher willingness to talk to others about donation @ weeks after intervention .


These findings underscore the importance of including the patient 's social network in LDKT education and the potential of the HC intervention to reduce racial disparity in LDKT rates .


Shared decision making is a crucial component of evidence-based practice , but a lack of training in the `` how to '' of it is a major barrier to its uptake .


To evaluate the effectiveness of a brief intervention for facilitating shared decision making skills in clinicians and student clinicians .


Multi-centre randomized controlled trial .


One hundred and seven medical students , physiotherapy or occupational therapy students undertaking a compulsory course in evidence-based practice as part of their undergraduate or postgraduate degree from two Australian universities .


The @-h small-group intervention consisted of facilitated critique of five-step framework , strategies , and pre-recorded modelled role-play .


Both groups were provided with a chapter about shared decision making skills .


The primary outcome was skills in shared decision making and communicating evidence -LSB- Observing Patient Involvement ( OPTION ) scale , items from the Assessing Communication about Evidence and Patient Preferences ( ACEPP ) Tool -RSB- , rated by a blinded assessor from videorecorded role-plays .


confidence in these skills and attitudes towards patient-centred communication ( Patient Practitioner Orientation Scale ( PPOS ) ) .


Of participants , @ % ( @ ) completed the primary outcome measures .


Two weeks post-intervention , intervention group participants scored significantly higher on the OPTION scale ( adjusted group difference = @ , @ % CI @ to @ ) , ACEPP items ( difference = @ , @ % CI @ to @ ) , confidence measure ( difference = @ , @ % CI @ to @ ) , and the PPOS sharing subscale ( difference = @ , @ % CI @ to @ ) .


There was no significant difference for the PPOS caring subscale .


This brief intervention was effective in improving student clinicians ' ability , attitude towards , and confidence in shared decision making facilitation .


Following further testing of the longer-term effects of this intervention , incorporation of this brief intervention into evidence-based practice courses and workshops should be considered , so that student clinicians graduate with these important skills , which are typically neglected in clinician training .


This randomised trial tested ( i ) whether a home-based expressive writing ( EW ) intervention improves quality of life in patients with colorectal cancer ( CRC ) and ( ii ) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings .


Patients treated for CRC were randomised to an EW ( n = @ ) or control writing ( CW ; n = @ ) group .


Assessments were completed at @ month pre - and post-intervention .


Sex and perceived social constraints on disclosure were evaluated as moderators .


Primary outcomes were depressive symptoms , sleep problems and quality of life indicators .


Eighty-one per cent of participants completed all writing assignments .


Consistent with hypotheses , relative to the CW group , participants in the EW group expressed more negative emotion in writing and rated their writings as more meaningful , personal and emotionally revealing .


There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes .


Although EW is feasible to use with persons who have CRC , it was not effective as a stand-alone psychotherapeutic intervention .


Neither was it more effective for men nor for people who felt they could not freely disclose cancer-related concerns and feelings .


Ideal fluid management during surgery still poses a clinical dilemma gauging the benefits and adverse effects .


This randomized controlled trial compared the tissue perfusion and coagulation profiles under clinically equivalent hydroxyethyl starch ( HES @/@ @ ) and lactated Ringer 's solution ( LR ) .


Eighty-four patients undergoing major abdominal surgery were randomized to receive either HES or LR .


Tissue perfusion parameters using heart rate , arterial blood pressure , central venous pressure , cardiac index , stroke volume index , and central venous oxygen saturation were measured at T@ ( baseline ) , T@ ( start of surgery ) , T@ ( @ hour after start of surgery ) , and T@ ( end of surgery ) .


Coagulation parameters using thrombelastography ( TEG ) were measured at T@ ( baseline ) , T@ ( after @mL/kg fluid transfused ) , and T@ ( @ hours after baseline ) .


The total amount of fluid administrated was @ mL in HES group and @ mL in LR group ( p < @ ) .


The parameters of tissue perfusion and TEG did not differ significantly between groups at any time point except for a transient decrease in clot kinetic and clot strength at T@ for HES group .


There was no significant difference in blood loss and consumption of blood products between the two fluids .


HES @/@ @ is a more efficient intravascular volume expander to maintain tissue perfusion than conventional crystalloid .


Transient hypocoagulability induced by HES @/@ @ does not warrant excessive blood loss and blood transfusion .


To determine the relationship between host immunity and the characteristics of viral infection or nucleoside analogues ( NAs ) themselves in patients with chronic hepatitis B ( CHB ) receiving NA therapy .


Fifty-two hepatitis B envelope antigen ( HBeAg ) positive CHB patients were enrolled and divided equally into two groups .


One group received telbivudine ( LDT , @ mg/d ) , and the other group received lamivudine ( LAM , @ mg/d ) .


Clinical , virological and immunological parameters were assessed at the baseline and at @ , @ , @ , @ and @ wk .


Both groups achieved significant hepatitis B virus ( HBV ) replication inhibition and alanine aminotransferase normalization at @ wk .


At the baseline , compared to healthy controls , CHB patients had a lower circulating CD@ T cell frequency ( @ % @ % vs @ % @ % , P = @ ) and higher frequencies of programmed death @ positive CD@ T cells ( PD-@ + CD@ T ) ( @ % @ % vs @ % @ % , P = @ ) and CD@ + CD@ + FoxP@ + T regulatory cells ( Tregs ) ( @ % @ % vs @ % @ % , P = @ ) .


On therapy , at the beginning @ wk with the levels of hepatitis B virus deoxyribonucleic acid ( HBV DNA ) and HBeAg declining , the frequencies of PD-@ + CD@ T cells and Treg cells gradually and significantly declined at @ and @ wk in both therapy groups .


At treatment week @ , patients treated with LDT had a lower frequency of PD-@ + CD@ T cells compared to patients treated with LAM ( @ % @ % vs @ % @ % , P = @ ) .


The frequency of PD-@ + CD@ T cells in all of the CHB patients was significantly correlated with both the HBV DNA level ( r = @ , P = @ ) and HBeAg level ( r = @ , P = @ ) at treatment week @ , but the frequency of Treg cells was only significantly correlated with the HBeAg level ( r = @ , P = @ ) .


Furthermore , the ability of CD@ T cells to secrete pro-inflammatory cytokines was partially restored after @ wk of therapy .


NA-mediated HBV suppression could down-regulate the production of negative regulators of host immunity during the first @ wk of therapy and could partially restore the ability of CD@ T cells to secrete pro-inflammatory cytokines .


This immune modulating response may be correlated with the levels of both HBV DNA and HBeAg .


Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness .


To assess whether an enhanced medical home providing comprehensive care prevents serious illness ( death , intensive care unit -LSB- ICU -RSB- admission , or hospital stay > @ days ) and/or reduces costs among children with chronic illness .


Randomized clinical trial of high-risk children with chronic illness ( @ emergency department visits , @ hospitalizations , or @ pediatric ICU admissions during previous year , and > @ % estimated risk for hospitalization ) treated at a high-risk clinic at the University of Texas , Houston , and randomized to comprehensive care ( n = @ ) or usual care ( n = @ ) .


Enrollment was between March @ and February @ ( when predefined stopping rules for benefit were met ) and outcome evaluations continued through August @ , @ .


Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care .


Usual care was provided locally in private offices or faculty-supervised clinics without modification .


Primary outcome : children with a serious illness ( death , ICU admission , or hospital stay > @ days ) , costs ( health system perspective ) .


Secondary outcomes : individual serious illnesses , medical services , Medicaid payments , and medical school revenues and costs .


In an intent-to-treat analysis , comprehensive care decreased both the rate of children with a serious illness ( @ per @ child-years vs @ for usual care ; rate ratio -LSB- RR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ) , and total hospital and clinic costs ( $ @,@ vs $ @,@ per child-year , respectively ; cost ratio , @ -LSB- @ % CI , @-@ @ -RSB- ) .


In analyses of net monetary benefit , the probability that comprehensive care was cost neutral or cost saving was @ % .


Comprehensive care reduced ( per @ child-years ) serious illnesses ( @ vs @ for usual care ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ) , emergency department visits ( @ vs @ ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ) , hospitalizations ( @ vs @ ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ) , pediatric ICU admissions ( @ vs @ ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ) , and number of days in a hospital ( @ vs @ ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Medicaid payments were reduced by $ @ ( @ % CI , $ @ - $ @,@ ) per child-year .


Medical school losses ( costs minus revenues ) increased by $ @ ( @ % CI , $ @ - $ @ ) per child-year .


Among high-risk children with chronic illness , an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs .


These findings from a single site of selected patients with a limited number of clinicians require study in larger , broader populations before conclusions about generalizability to other settings can be reached .


To compare the effect of @ h of prolonged sitting on resting blood pressure with a similar duration of sitting combined with intermittent brief bouts of light-intensity or moderate-intensity physical activity .


Overweight/obese adults ( n = @ ; aged @-@ years ) were recruited for a randomized three-treatment crossover trial with a one-week washout between treatments : @ ) uninterrupted sitting ; @ ) sitting with @ min bouts of light-intensity walking at @ km/h every @ min ; and , @ ) sitting with @ min bouts of moderate-intensity walking at between @ and @ km/h every @ min .


After an initial @ h period seated , participants consumed a test meal ( @ g carbohydrate , @ g fat ) and completed each condition over the next @ h. Resting blood pressure was assessed oscillometrically every hour as a single measurement , @ min prior to each activity bout .


GEE models were adjusted for sex , age , BMI , fasting blood pressure and treatment order .


After adjustment for potential confounding variables , breaking up prolonged sitting with light and moderate-intensity activity breaks was associated with lower systolic blood pressure -LSB- light : @ @ mmHg ( estimated marginal mean SEM ) , P = @ ; moderate : @ @ mmHg , P = @ -RSB- , compared to uninterrupted sitting ( @ @ mmHg ) .


Diastolic blood pressure was also significantly lower during both of the activity conditions ( light : @ @ mmHg , P = @ ; moderate : @ @ mmHg , P = @ ) compared to uninterrupted sitting ( @ @ mmHg ) .


No significant between-condition differences were observed in mean arterial pressure or heart rate .


Regularly breaking up prolonged sitting may reduce systolic and diastolic blood pressure .


Physical illnesses frequently co-occur with depression and substance use disorders and may impact their improvement .


Physical illness symptoms may overlap with or exacerbate somatic symptoms of depression .


Individuals may use substances to cope with symptoms of physical illness .


We examined whether chronic physical health problems moderated changes in depression and substance use among dual diagnosed individuals during and in the year following treatment .


Participants were recruited from a Veterans Affairs dual diagnosis outpatient program between March @ and November @ and were randomized to either Integrated Cognitive-Behavioral Therapy or Twelve-Step Facilitation Therapy .


A total of @ veterans with assessment data for the variables of interest were included in analyses .


Participants completed quarterly depression , substance use , and health assessments over an @ month period .


We used linear-mixed effects models to analyze patterns of change for depression and substance use .


Individuals with severe chronic health problems and higher intake depression showed slower improvements in both nonsomatic and somatic depression symptoms .


Individuals with severe chronic health problems and higher midtreatment substance use showed less improvement in substance use .


Assessing and addressing physical health issues during depression and substance use disorder treatment may improve outcomes .


Several different surgical techniques have been described to address the coracoclavicular ( CC ) ligaments in acromioclavicular ( AC ) joint injuries .


However , very few techniques focus on reconstructing the AC ligaments , despite its importance in providing stability .


The purpose of our study was to compare the biomechanical properties of two free-tissue graft techniques that reconstruct both the AC and CC ligaments in cadaveric shoulders , one with an extramedullary AC reconstruction and the other with an intramedullary AC reconstruction .


We hypothesized intramedullary AC reconstruction will provide greater anteroposterior translational stability and improved load to failure characteristics than an extramedullary technique .


Six matched cadaveric shoulders underwent translational testing at @ N and @ N in the anteroposterior and superoinferior directions , under AC joint compression loads of @ N , @ N , and @ N.


After the AC and CC ligaments were transected , one of the specimens was randomly assigned the intramedullary free-tissue graft reconstruction while its matched pair received the extramedullary graft reconstruction .


Both reconstructed specimens then underwent repeat translational testing , followed by load to failure testing , via superior clavicle distraction , at a rate of @ mm/min .


Intramedullary reconstruction provided significantly greater translational stability in the anteroposterior direction than the extramedullary technique for four of six loading conditions ( p < @ ) .


There were no significant differences in translational stability in the superoinferior direction for any loading condition .


The intramedullary reconstructed specimens demonstrated improved load to failure characteristics with the intramedullary reconstruction having a lower deformation at yield and a higher ultimate load than the extramedullary reconstruction ( p < @ ) .


Intramedullary reconstruction of the AC joint provides greater stability in the anteroposterior direction and improved load to failure characteristics than an extramedullary technique .


Reconstruction of the injured AC joint with an intramedullary free tissue graft may provide greater strength and stability than other currently used techniques , allowing patients to have improved clinical outcomes .


Pharmacokinetic data regarding a drug-drug interaction between everolimus and tacrolimus are sparse .


In a pharmacokinetic substudy of the randomized ASSET trial , @ de novo kidney transplant patients receiving very low ( @-@ ng/mL ) or low ( @-@ ng/mL ) tacrolimus exposure after month @ , both with everolimus and steroids , provided area under the curve ( AUC ) concentration profiles at day @ and months @ , @ , and @ .


At month @ , mean values for tacrolimus trough concentration ( C@ ) , peak concentration ( Cmax ) , and AUC@-@ in the very low tacrolimus group were approximately half that in the low tacrolimus group , but everolimus dose , C@ , Cmax , and AUC@-@ were virtually identical in both groups .


In a cross-study comparison with data at months @ and @ from the pharmacokinetic substudy of the A@ trial , in which patients received cyclosporine , mean values for everolimus C@ , Cmax and AUC@-@ were similar to those in the ASSET trial but the everolimus dose needed to achieve similar exposure was @ - to @-fold higher with concomitant tacrolimus versus cyclosporine .


Everolimus exposure is unaffected when tacrolimus exposure is down-titrated within the trough concentration range of @-@ ng/mL .


Higher doses of everolimus are needed to achieve a given exposure when combined with tacrolimus versus cyclosporine .


Patient-relevant treatment benefit is traditionally measured with health-related quality of life ( HRQoL ) instruments .


The Patient Benefit Index ( PBI ) methodology allows for a more direct measurement , with the patients rating both importance and achievement of treatment goals .


Here , we developed and validated a PBI version specific for the assessment of benefit in lymphedema and lipedema treatment ( PBI-L ) .


The development included five steps : ( @ ) open item collection ; ( @ ) consensus of items in a multidisciplinary expert panel ; ( @ ) application of the German PBI-L in a cross-sectional study ( n = @ ) ; ( @ ) translation into English ; ( @ ) application of the English PBI-L in a randomized clinical trial ( n = @ ) .


Subscales were developed using factor analysis .


Construct validity was analyzed by correlating PBI-L and convergent criteria such as HRQoL and quality of care .


To test for responsiveness , the association to change in HRQoL measures was computed .


Floor and ceiling effects were low .


There were few missing values .


Two well-interpretable subscales were found with Cronbach 's alpha > @ each .


Global and subscale scores correlated with convergent criteria and with change in disease-specific HRQoL , but not with change in generic HRQoL .


The PBI-L is an internally consistent , valid , and responsive instrument for the assessment of patient-relevant benefit of edema treatment .


Heart failure ( HF ) is a major public health problem affecting predominantly older adults .


Nonadherence to diet remains a significant contributor to acute decompensated HF ( ADHF ) .


The sodium-restricted Dietary Approaches to Stop Hypertension ( DASH/SRD ) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines .


We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life ( QOL ) in older adults after hospitalization for ADHF .


This is a @-center , randomized , single-blind , controlled trial of @-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization .


Sixty-six subjects will be randomized in a @:@ stratified fashion by gender and left ventricular ejection fraction ( < @ % vs @ % ) .


Study subjects will receive either preprepared , home-delivered DASH/SRD-compliant meals or usual dietary advice for @weeks after hospital discharge .


Investigators will be blinded to group assignment , food diaries , and urinary electrolyte measurements until study completion .


The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to @weeks postdischarge .


Safety evaluation will focus on hypotension , renal insufficiency , and hyperkalemia .


Exploratory end points include echocardiography , noninvasive vascular testing , markers of oxidative stress , and salt taste sensitivity .


This randomized controlled trial will test the efficacy , feasibility , and safety of @weeks of DASH/SRD after ADHF hospitalization .


By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF , we will address a critical evidence gap in the care of older patients with ADHF .


If effective and safe , this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF .


It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) .


The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH .


In this prospective study patients had to have prostate volume ( PV ) < @ mL , International Prostate Symptom Score ( IPSS ) of @-@ , Quality of Life score ( QoLs ) > @ , a maximal flow rate ( Qmax ) of @-@ mL/s , with post voiding residual volume ( PVR ) < @ mL and serum prostatic antigen ( PSA ) < @ ng/mL .


TAM ( @ mg ) was administered once a day , SR ( @ mg ) daily or SR ( @ mg ) + TAM ( @ mg ) daily for a median period of @ months .


A total of @ patients were recruited , whereas @ patients were fully available : @ into the group TAM , @ into the group SR and @ into the group TAM + SR. .


There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters .


No difference was found among the @ treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR .


During the treatment period @ ( @ % ) of the patients managed with TAM and @ ( @ % ) with TAM + SR had drug - treated with related adverse reactions .


No adverse effect was detected in the group SR. .


Treatment of BPH by both SR and TAM seems to be efficacious alone .


None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits .


Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH .


This study investigated the effect of high frequency transcutaneous electric nerve stimulation ( TENS ) as a pain relieving complementary therapy at the transition from epidural ( EDA ) to general analgesia after pancreatic surgery by horizontal , abdominal incision .


Fifty-five consecutive patients undergoing pancreatic resection were enrolled in the study and randomly assigned to active or sham TENS treatment .


Twenty subjects were included in the analysis .


Pain , quality of recovery and additional analgesia consumption were measured during the @hof transition from EDA to general analgesia .


Additional analgesic consumption and pain estimations at @hafter EDA termination differed between the two groups , but was not statistically significant .


This study did not find support to reject use of high frequency TENS as complement during transition from EDA to general analgesia after major abdominal surgery with horizontal incision .


To assess the efficacy of Yiqi Zhujing Particle in the treatment of idiopathic oligoasthenozoospermia .


We equally randomized @ patients with idiopathic oligoasthenozoospermia to a control group and a Yiqi Zhujing group , the former treated with oral medication of zinc gluconate liquid ( @ ml , bid ) and vitamin E ( @ mg , bid ) , and the latter given Yiqi Zhujing Granule ( @ packet , bid ) in addition , both for @ months .


We compared the semen parameters and biochemical indexes of the seminal plasma obtained before and after medication between the two groups of patients .


After @ months of treatment , remarkable improvement was observed in the percentage of progressively motile sperm and sperm viability in the control group ( P < @ ) as well as in the total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability in the Yiqi Zhujing group ( P < @ ) .


The total sperm count , sperm concentration , percentage of progressively motile sperm , and sperm viability were even more significantly improved in the Yiqi Zhujing than in the control group ( P < @ ) .


Besides , both groups showed different degrees of improvement in the biochemical indexes of the seminal plasma , and the Yiqi Zhujing group exhibited even more significant improvement in seminal plasma zinc , alpha-glucoside enzyme , seminal plasma fructose , and acid phosphatase than the control ( P < @ ) .


The improvement of sperm concentration was correlated positively with the change of seminal plasma zinc ( r = @ , P < @ ) but negatively with that of seminal plasma fructose after treatment ( r = -@ , P < @ ) .


There was a positive correlation between the alpha-glucoside enzyme level and sperm viability ( r = @ , P < @ ) .


Yiqi Zhujing Particle is effective for idiopathic oligoasthenozoospermia by significantly improving the total sperm count , sperm concentration , percentage of progressively motile sperm , sperm viability , seminal plasma zinc , seminal plasma fructose , and alpha-glucoside enzyme .


Agents that augment GLP-@ effects enhance glucose-dependent - cell insulin production and secretion and thus are hoped to prevent progressive impairment in insulin secretion characteristic of type @ diabetes ( T@D ) .


The purpose of this study was to evaluate GLP-@ effects on - cell secretory capacity , an in vivo measure of functional - cell mass , early in the course of T@D .


We conducted a randomized controlled trial in @ subjects with early T@D who received the GLP-@ analog exenatide ( n = @ ) , the dipeptidyl peptidase IV inhibitor sitagliptin ( n = @ ) , or the sulfonylurea glimepiride ( n = @ ) as an active comparator insulin secretagogue for @ months .


Acute insulin responses to arginine ( AIRarg ) were measured at baseline and after @ months of treatment with @ days of drug washout under fasting , @ mg/dL ( glucose potentiation of arginine-induced insulin release -LSB- AIRpot -RSB- ) , and @ mg/dL ( maximum arginine-induced insulin release -LSB- AIRmax -RSB- ) hyperglycemic clamp conditions , in which AIRmax provides the - cell secretory capacity .


The change in AIRpot was significantly greater with glimepiride versus exenatide treatment ( P < @ ) , and a similar trend was notable for the change in AIRmax ( P = @ ) .


Within each group , the primary outcome measure , AIRmax , was unchanged after @ months of treatment with exenatide or sitagliptin compared with baseline but was increased with glimepiride ( P < @ ) .


- Cell glucagon secretion ( AGRmin ) was also increased with glimepiride treatment ( P < @ ) , and the change in AGRmin trended higher with glimepiride than with exenatide ( P = @ ) .


After @ months of treatment , exenatide or sitagliptin had no significant effect on functional - cell mass as measured by - cell secretory capacity , whereas glimepiride appeared to enhance - and - cell secretion .


The aim of this study was to assess whether bladder training ( BT ) combined with high-intensity pelvic floor muscle training ( BT+PFMT ) results in better outcomes in the short term than BT alone on female urinary incontinence ( UI ) .


We randomly assigned @ women with diagnoses of stress UI ( SUI , n = @ ) , urgency UI ( UUI , n = @ ) , or mixed UI ( MUI , n = @ ) to @ weeks of BT+PFMT or BT alone ( control group ) .


The primary outcome measure was self-reported improvement .


Secondary outcome measures were UI severity , symptom distress , quality of life ( QOL ) , mean number of UI episodes and micturitions per day , and pelvic floor muscle strength and endurance ( PFME ) .


Overall and in the SUI and MUI subgroups , significantly more patients in the BT+PFMT group reported cured and improved symptoms .


Overall and in SUI patients , the BT+PFMT group also improved to significantly greater degree in UI severity , symptom distress , QOL , daily UI episodes , and PFME .


The only parameter showing more improvement in patients with UUI was QOL , and UI severity in patients with MUI ( p < @ ) .


There were no other significant differences between the two study groups in overall and subgroup analysis ( p > @ ) .


High-intensity PFMT combined with BT is more effective than BT alone in the short term for treating UI or SUI .


It appears that the combination therapy may also lead to greater benefits for patients with UUI and MUI .


Based on the results of this study , further studies with larger sample sizes ( for UUI ) and long-term follow-ups are warranted .


To examine the effect of certolizumab pegol ( CZP ) on patient-reported outcomes ( PROs ) in psoriatic arthritis ( PsA ) patients with and without prior tumor necrosis factor ( TNF ) inhibitor exposure .


The ongoing phase III RAPID-PsA trial was double blind and placebo controlled to week @ .


Patients were randomized @:@:@ to placebo every @ weeks or CZP @ mg at weeks @ , @ , and @ , followed by either CZP @ mg every @ weeks or CZP @ mg every @ weeks .


PRO measures evaluated were the Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , health status ( measured by the Short Form @ -LSB- SF-@ -RSB- health survey ) , Psoriatic Arthritis Quality of Life ( PsAQOL ) , Fatigue Assessment Scale , patient assessment of pain ( visual analog scale ) , and Dermatology Life Quality Index ( DLQI ) .


Post hoc analyses of PROs in patients with and without prior TNF inhibitor exposure were conducted .


Change from baseline for all PROs was analyzed for the randomized population using analysis of covariance with last observation carried forward imputation .


A total of @ patients were randomized .


Twenty percent had received a prior TNF inhibitor .


Baseline demographics were similar between the treatment groups .


At week @ , clinically meaningful differences in HAQ DI , SF-@ , PsAQOL , fatigue , pain , and DLQI were observed in both CZP arms versus placebo ( P < @ ) , irrespective of prior TNF inhibitor exposure .


More CZP-treated patients reached SF-@ general population norms than placebo-treated patients .


Both CZP dosing schedules provided rapid improvements in PROs across multiple disease aspects in patients with PsA .


The benefits of CZP treatment for health-related quality of life were seen across generic , PsA-specific , and dermatology-specific measures and were observed in patients regardless of prior TNF inhibitor exposure .


The purpose of the study was to evaluate the effect of BodyBalance ( ) training on balance , functional task performance , fear of falling , and health-related quality of life in adults aged over @ years .


A total of @ healthy , active adults aged @ years completed the randomized controlled trial .


Balance , functional task performance , fear of falling , and self-reported quality of life were assessed at baseline and after @ weeks .


Participants either undertook two sessions of BodyBalance per week for @ weeks ( n = @ ) or continued with their normal activities ( n = @ ) .


Significant group-by-time interactions were found for the timed up and go ( P = @ ) , @-second chair stand ( P = @ ) , and mediolateral center-of-pressure range in narrow stance with eyes closed ( P = @ ) .


There were no significant effects on fear of falling or self-reported quality of life .


Twelve weeks of BodyBalance training is effective at improving certain balance and functional based tasks in healthy older adults .


Acute inflammation induced by administration of Escherichia coli lipopolysaccharide endotoxin ( LPS ) reduces plasma concentrations of vitamin C and impairs vascular endothelium-derived nitric oxide ( NO ) bioactivity .


We tested the hypothesis that systemically administered high dose vitamin C restores the endogenous anti-oxidant potential and improves NO-dependent vasodilatation in the forearm vasculature .


@ male subjects were enrolled in this balanced , placebo controlled cross-over study .


Forearm blood flow ( FBF ) reactivity to acetylcholine ( ACh ) and glyceryl-trinitrate ( GTN ) , a sensitive test for endothelial function , was assessed at baseline and @h after LPS-administration ( @ IU/kg i.v ) .


The effect of two different doses of intravenous vitamin C ( Vitamin C-Injektopas ) , @ mg/kg and @ mg/kg over @h , or placebo on forearm vascular function was studied after LPS .


LPS caused transient flu-like symptoms , decreased plasma vitamin C concentrations and reduced the ACh-dependent increase in FBF by up to @ % .


Vitamin C at a mean plasma concentration of @ or @ mmol/L restored the response to ACh compared to baseline .


High dose systemic vitamin C recovers LPS-induced endothelium-dependent vasodilation in the forearm resistance vasculature .


This provides a rationale for a further clinical study of the systemic vitamin C effect under inflammatory conditions .


The prevalence of multiple somatic symptoms is high in primary and hospital outpatient populations .


Multiple somatic symptoms may be present in patients sick-listed because of low back pain ( LBP ) and may be associated with increased risk of not returning to work ( RTW ) .


To explore whether multiple somatic symptoms in a subset of patients with nonspecific LBP was associated with RTW , sickness absence ( SA ) , or other social benefits .


The study was a cohort study based on a randomized clinical trial with a prospective @-year follow-up period .


Patients were referred from general practices to the Spine Center , Regional Hospital Silkeborg , Denmark .


Patients were @ sick-listed employees ( @-@ weeks ) , with nonspecific LBP as their prime reason for SA .


Exclusion criteria were unemployment , radiculopathy , LBP surgery within the past year , previous lumbar fusion , suspected cauda equina syndrome , progressive paresis or other serious back disease , pregnancy , known substance abuse , or primary psychiatric diagnosis .


Self-reported health was assessed by the LBP rating scale and questions about pain and health in general .


Disabilities were measured by the Roland Morris Questionnaire , the Short Form-@ , and the Fear-Avoidance Beliefs Questionnaire .


Work-related questions comprised expectations about RTW and risk of losing job because of SA .


The Common Mental Disorder Questionnaire ( subscale SCL-SOM ) was used to assess multiple somatic symptoms ( @ items ) .


We categorized multiple somatic symptoms into four groups based on the SCL-SOM sum score : < @ , @ to @ , @ to @ and > @ .


Status of SA ( > @ weeks ) and RTW were gathered from a national database ( DREAM ) .


The patients ( N = @ ) were randomized into either multidisciplinary or brief intervention at the Spine Center ( @-@ ) .


Both interventions comprised clinical examination and advice by a physiotherapist and a rheumatologist .


Data were collected from questionnaires at baseline ( inclusion ) and @ year after inclusion .


Data on SA benefits were gathered from the DREAM database that contains data on all social transfer payments ( such as sick leave benefits and other disability benefits ) registered on a weekly basis .


All health factors , female gender , and poor work ability were significantly associated with a higher level of multiple somatic symptoms .


The percentage of persons with SA increased significantly with the symptom score after @ year , and the duration of SA remained significantly longer after @ years of follow-up between the multiple somatic symptoms groups .


The percentages with RTW after @ and @ years were negatively associated with a higher level of multiple somatic symptoms at baseline .


We found no difference between the intervention groups .


A higher level of multiple somatic symptoms was significantly associated with poor health and work ability at baseline and with longer duration of SA and unsuccessful RTW through a @-year follow-up period .


Electrical and pharmacological cardioversion ( ECV , PCV ) are important treatment options for symptomatic patients with recent onset atrial fibrillation ( AF ) .


RHYTHM-AF is an international registry of present-day cardioversion providing information that is not currently available on country differences and acute and long-term arrhythmia outcomes of ECV and PCV .


@ patients were enrolled , of whom @ % underwent CV .


All patients were followed for @ months .


There were large variations concerning mode of CV used , ECV being heterogeneous .


A choice of PCV drug depended on the clinical patient profile .


Sinus rhythm was restored in @ % of patients by ECV and in @ % after PCV .


Among patients not undergoing CV during admission , @ % spontaneously converted to sinus rhythm within @h .


ECV was most successful in patients pretreated with antiarrhythmic drugs ( mostly amiodarone ) .


PCV was enhanced by class Ic antiarrhythmic drugs ; conversion rate on amiodarone was similar to that seen with rate control drugs .


Female patients and those with paroxysmal and first detected AF as well as those without previous ECV responded well to PCV .


The median duration of hospital stay was @ and @ h for ECV and PCV patients , respectively .


There were very few CV-related complications regardless of mode of CV .


Chronic maintenance of sinus rhythm was enhanced in patients on chronic antiarrhythmic drugs , beta-blockers or inhibitors of the renin-angiotensin system .


Mode of CV varied significantly , but both PCV and ECV were safe and effective .


Class Ic drugs were most effective conversion drugs , but amiodarone is used most frequently despite providing merely rate control rather than shorten time to conversion .


Systemic hypothermia may reduce infarct size if established before reperfusion .


The large surface area of the bowel may facilitate rapid hypothermia .


We therefore examined the feasibility , safety , and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .


Patients with ST-segment-elevation myocardial infarction within @ hours of symptom onset were randomized to peritoneal hypothermia before and for @ hours after percutaneous coronary intervention versus control .


The primary safety end point was the @-day composite rate of death , reinfarction , ischemia-driven target vessel revascularization , major bleeding , sepsis , pneumonia , peritonitis , severe arrhythmia , or renal failure .


The primary efficacy end point was infarct size assessed by cardiac MRI on day @ to @ .


Fifty-four patients were randomized at @ centers to hypothermia ( n = @ ) versus control ( n = @ ) .


Hypothermia was successfully initiated in @ % of patients , and median -LSB- interquartile range -RSB- temperature at first balloon inflation was @ -LSB- @-@ @ -RSB- C. Median door-to-balloon times in the hypothermia and control groups were @ -LSB- @-@ -RSB- and @ -LSB- @-@ -RSB- minutes , respectively ( P = @ ) .


The primary safety end point occurred in @ ( @ % ) and @ ( @ % ) patients in the hypothermia and control groups , respectively ( P = @ ) , including @ versus @ stent thrombosis events .


Infarct size was @ % -LSB- @-@ @ -RSB- and @ % -LSB- @-@ @ -RSB- in the hypothermia and control groups , respectively ( P = @ ) .


Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction .


However , in the present randomized trial , peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size .


To determine whether concurrent chemoradiotherapy ( CCRT ) can improve survival rates compared to the neoadjuvant chemotherapy ( NACT ) regimen in locoregionally advanced nasopharyngeal carcinoma ( NPC ) patients .


A total of @ patients with biopsy-proven NPC were randomly assigned to receive NACT followed by radical radiotherapy ( RT ) then adjuvant chemotherapy ( AC ) or CCRT followed by AC .


With a median follow-up of @ months , the @-year overall survival ( OS ) rate did not differ significantly between two groups ( @ % vs @ % in CCRT and NACT group respectively , P = @ , HR = @ , @ % CI @-@ @ ) .


Metastasis-free survival ( MFS ) rate was significantly improved by the CCRT ( @ % vs @ % , P = @ , HR = @ , @ % CI @-@ @ ) .


Subgroup analysis indicated that the benefit of CCRT was derived from N@/N@ tumors ( @ % vs @ % , P = @ , HR = @ , @ % CI @-@ @ ) .


Higher rates of mucositis ( @ % vs. @ % P = @ ) and vomiting ( @ % vs. @ % P = @ ) were noted in the CCRT arm .


Late toxicities were similar in two groups .


The updated results demonstrated no significant survival benefit of CCRT over NACT in patients with locoregionally advanced NPC .


CCRT only showed significant MFS efficacy in T@-@N@-@ populations .


Lumbar transforaminal epidural injections are commonly utilized to treat radicular pain due to intervertebral disc herniation .


This study aims to determine if there was a major difference in effectiveness between particulate and nonparticulate corticosteroids for acute radicular pain due to lumbar disc herniation .


A multicenter , double blind , prospective , randomized trial on @ consecutive subjects with acute uni-level disc herniation resulting in unilateral radicular pain .


All subjects received a single level transforaminal epidural steroid injection with either dexamethasone or triamcinolone .


Repeat injections were allowed as determined by the blinded physician and subjects .


Primary outcomes included : number of injections received , surgical rates , and categorical pain scores at @ weeks , @ months , and @ months .


Secondary outcomes included mean Oswestry Disability Index .


Both triamcinolone and dexamethasone resulted in statically significant improvements in pain and function at @ weeks , @ months , and @ months , without clear differences between groups .


The surgical rates were comparable with @ % of the dexamethasone group and @ % of the triamcinolone group receiving surgery .


There was a statistically significant difference in the number of injections received , with @ % of the dexamethasone group receiving three injections vs only @ % of the triamcinolone group .


Transforaminal epidural corticosteroid injections are an effective treatment for acute radicular pain due to disc herniation , and frequently only require @ or @ injections for symptomatic relief .


Dexamethasone appears to possess reasonably similar effectiveness when compared with triamcinolone .


However , the dexamethasone group received slightly more injections than the triamcinolone group to achieve the same outcomes .


To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention .