Polyunsaturated fatty acid ( PUFA ) and monounsaturated fatty acid ( MUFA ) intakes significantly increased from baseline in both groups .


High egg consumption did not have an adverse effect on the lipid profile of people with T@D in the context of increased MUFA and PUFA consumption .


This study suggests that a high-egg diet can be included safely as part of the dietary management of T@D , and it may provide greater satiety .


This trial was registered at the Australia New Zealand Clinical Trials Registry ( http://www.anzctr.org.au/ ) as ACTRN@ .


Patients with Mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin .


However , rifampicin is known to reduce the serum levels of clarithromycin .


It remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the Mycobacterium avium complex pulmonary disease treatment regimen .


To compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of Mycobacterium avium lung disease .


In a preliminary open-label study , we randomly assigned newly diagnosed , but as-yet untreated , patients with disease caused by Mycobacterium avium complex without HIV infection to either the three-drug or the two-drug regimen for @ months .


The primary endpoint was the conversion of sputum cultures to negative after @ months of treatment .


Patient data were analyzed using the intention-to-treat method .


Of @ eligible patients , @ were assigned to the three-drug regimen and @ to the two-drug regimen .


The rate of sputum culture conversion was @ % with the three-drug regimen and @ % with the two-drug regimen ( difference , -@ % -LSB- @ % confidence interval , -@ to @ -RSB- ) .


The incidence of adverse events leading to the discontinuation of treatment was @ and @ % for the three-drug and the two-drug regimens , respectively .


This preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for Mycobacterium avium complex lung disease .


Our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens .


Clinical trial registered with http://www.umin.ac.jp/english/ ( UMIN@ ) .


Insomnia patients complain that mental events keep them awake .


This study investigates how cognitive behavioural therapy ( CBT ) affects such events and considers how attributional , cognitive and psychopathological symptoms may mediate sleep improvement .


A pragmatic , parallel-group randomized controlled trial of @ adults ( @ F : ( mean @ years ( @-@ years ) ) meeting Diagnostic and Statistical Manual of Mental Disorders , @th Edition ( DSM-@ ) criteria for insomnia disorder , assigned to CBT ( n = @ ; @ F ) , imagery relief therapy ( IRT placebo ; n = @ ; @ F ) , or treatment as usual ( TAU ; n = @ ; @ F ) , was conducted .


CBT/IRT comprised six online sessions delivered by an animated therapist , with automated web/e-mail support .


CBT users had access to a moderated community .


TAU comprised ` usual care ' .


Participants completed the Sleep Disturbance Questionnaire ( SDQ ) , Glasgow Content of Thoughts Inventory ( GCTI ) , Depression Anxiety and Stress Scales ( DASS ) and Sleep Condition Indicator ( SCI ) at baseline , post treatment and @-week follow-up .


The sample was characterised by mental arousal , notably ` trying too hard ' to sleep ( SDQ ) , and by ` sleep and sleeplessness ' and ` rehearsal and planning ' thoughts ( GCTI ) .


Treatment effects were observed for all SDQ domains ( e.g. , CBT vs. IRT : d = @ for ` trying too hard ' ) .


CBT was also superior to IRT on the GCTI ( e.g. , ` rehearsal and planning ' , d = @ ; ` sleep and sleeplessness ' , d = @ ) .


CBT vs. TAU comparisons yielded larger effects , whereas placebo effects ( IRT vs. TAU ) were small to moderate .


Hierarchical regression demonstrated partial mediation of SCI improvement by attributional and cognitive factors ( R@ = @-@ % ) following CBT .


Improvement in sleep efficiency appears to be independent of such factors .


Online CBT modifies sleep-related attributions , night-time thought content and psychopathology .


This process partly mediates improvement in DSM-@-defined insomnia .


Inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease .


The treatment gap is salient in resource-poor settings , especially when providing care for conflict-affected forced migrant populations .


Primary care is often the only available service option for the majority of forced migrants , and integration of mental health into primary care is a difficult task .


The proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations , in order to improve identification , treatment , and referral of patients with common mental disorders via the World Health Organization Mental Health Gap Action Programme ( mhGAP ) .


This pilot randomized controlled trial will recruit @ primary care practitioners ( PCP ) serving in the Puttalam and Mannar districts of Sri Lanka ( with displaced and returning conflict-affected populations ) .


The intervention arm will receive a structured training program based on the mhGAP intervention guide .


Primary outcomes will be rates of correct identification , adequate management based on set criteria , and correct referrals of common mental disorders .


A qualitative study exploring the attitudes , views , and perspectives of PCP on integrating mental health and primary care will be nested within the pilot study .


An economic evaluation will be carried out by gathering service utilization information .


In post-conflict Sri Lanka , an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement .


The proposed study will act as a local demonstration project , exploring the feasibility of formulating a larger-scale intervention study in the future , and is envisaged to provide information on engaging PCP , and data on training and evaluation including economic costs , patient recruitment , and acceptance and follow-up rates .


The study should provide important information on the WHO mhGAP intervention guide to add to the growing evidence base of its implementation .


Anti-inflammatory glucocorticoid ( GC ) therapy often induces hyperglycemia due to insulin resistance and islet-cell dysfunction .


Incretin-based therapies may preserve glucose tolerance and pancreatic islet-cell function .


In this study , we hypothesized that concomitant administration of the dipeptidyl peptidase-@ inhibitor sitagliptin and prednisolone in men at high risk to develop type @ diabetes could protect against the GC-induced diabetogenic effects .


Men with the metabolic syndrome but without diabetes received prednisolone @ mg once daily plus sitagliptin @ mg once daily ( n = @ ) , prednisolone ( n = @ ) or sitagliptin alone ( n = @ ) or placebo ( n = @ ) for @ days in a double-blind @ @ randomized-controlled study .


Glucose , insulin , C-peptide , and glucagon were measured in the fasted state and following a standardized mixed-meal test .


- cell function parameters were assessed both from a hyperglycemic-arginine clamp procedure and from the meal test .


Insulin sensitivity ( M-value ) was measured by euglycemic clamp .


Prednisolone increased postprandial area under the curve ( AUC ) - glucose by @ % ( P < @ vs placebo ) and postprandial AUC-glucagon by @ % ( P < @ ) .


Prednisolone reduced @st and @nd phase glucose-stimulated - and combined hyperglycemia-arginine-stimulated C-peptide secretion ( all P @ ) .


When sitagliptin was added , both clamp-measured - cell function ( P = NS for @st and @nd phase vs placebo ) and postprandial hyperglucagonemia ( P = NS vs placebo ) remained unaffected .


However , administration of sitagliptin could not prevent prednisolone-induced increment in postprandial glucose concentrations ( P < @ vs placebo ) .


M-value was not altered by any treatment .


Fourteen-day treatment with high-dose prednisolone impaired postprandial glucose metabolism in subjects with the metabolic syndrome .


Concomitant treatment with sitagliptin improved various aspects of pancreatic islet-cell function , but did not prevent deterioration of glucose tolerance by GC treatment .


Fluralaner is a novel systemic insecticide and acaricide .


The purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in Beagle dogs following single oral or intravenous ( i.v. ) administration .


Following the oral administration of @ , @ or @ mg fluralaner/kg body weight ( BW ) , formulated as chewable tablets or i.v. administration of @ mg fluralaner/kg BW , formulated as i.v. solution to @ Beagles , plasma samples were collected until @ days after treatment .


Plasma concentrations of fluralaner were measured using HPLC-MS/MS .


Pharmacokinetic parameters were calculated by non-compartmental methods .


After oral administration , maximum plasma concentrations ( C ( max ) ) were reached within @ day on average .


Fluralaner was quantifiable in plasma for up to @ days after single oral and i.v. treatment .


The apparent half-life of fluralaner was @-@ days and the mean residence time was @-@ days .


The apparent volume of distribution of fluralaner was @ L/kg , and clearance was @ L/kg/day .


Fluralaner is readily absorbed after single-dose oral administration , and has a long elimination half-life , long mean residence time , relatively high apparent volume of distribution , and low clearance .


These pharmacokinetic characteristics help to explain the prolonged activity of fluralaner against fleas and ticks on dogs after a single oral dose .


To evaluate blood pressure ( BP ) control utilizing the International Society on Hypertension in Blacks ( ISHIB ) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension .


This is a randomized controlled pilot study conducted in two Baltimore community-based physicians ' offices assigned adults ( @-@ years ) with uncontrolled hypertension ( systolic blood pressure -LSB- SBP -RSB- @ mm Hg ; diastolic blood pressure -LSB- DBP -RSB- @ mm Hg ) .


The study compares usual care to a community-based intervention .


In the usual care group , the patients ' BP was managed by the treating physician based on their normal office patient care protocol .


In the intervention group , usual care was provided but , a community health worker also gave comprehensive education and assessment to the patients based on the ISHIB IMPACT cardiovascular toolkit during study initiation and follow-up visits .


The main outcome of study was change in BP from baseline to six months .


A secondary outcome was the proportion of patients achieving BP < @ / < @ mm Hg at six months .


Fifty-four African American patients were enrolled ; @ completed six months of follow-up ( usual care , n = @ ; intervention , n = @ ) .


At six months the mean ( @ % CI ) change from baseline in SBP was significantly greater in the intervention group vs the usual care group : -@ ( -@ to -@ ) mm Hg vs -@ ( -@ to @ ) mm Hg ( P < @ ) .


Mean ( @ % CI ) change in DBP from baseline to six months was significantly greater for the intervention group vs the usual care group : -@ ( -@ to -@ ) mm Hg vs -@ ( -@ to -@ ) mm Hg ( P = @ ) .


Median change in BP was significantly greater for SBP in the intervention group compared with the usual care group ( P = @ ) , but not for DBP ( P = @ ) .


The proportion of patients achieving BP < @ / < @ at six months was @ % ( @/@ ) in the intervention group vs @ % ( @/@ ) in the usual care group ( P = @ ) .


This pilot study on the ISHIB IMPACT toolkit in managing uncontrolled hypertension in the African American community suggests better control of systolic BP and a tendency to better hypertension control with the community-based intervention .


The findings support further studies in clinical settings serving African American hypertensive patients to assess effectiveness of approaches for improving BP control and related outcomes .


The impact of dairy intake on cardiometabolic risk factors associated with metabolic syndrome ( MetS ) needs further research .


To investigate the impact of milk consumption on a wide array of cardiometabolic risk factors associated with MetS ( blood lipids , cholesterol homeostasis , glucose homeostasis , systemic inflammation , blood pressure , endothelial function ) in postmenopausal women with abdominal obesity .


In this randomized , crossover study , @ women with abdominal obesity consumed two @-week diets based on the National Cholesterol Education Program ( NCEP ) , one with @ servings/d of @ % fat milk per @kcal ( MILK ) and one without milk or other dairy ( NCEP ) .


The macronutrient composition of both diets was comparable ( @ % carbohydrates , @ % proteins , @ % fat and @ % saturated fat ) .


The MILK diet had no significant effect on LDL-C , triglycerides , LDL size , CRP and cell adhesion molecule concentrations and on indicators of insulin sensitivity .


The MILK diet reduced HDL-C , adiponectin , endothelin and fasting glucose levels as well blood pressure ( all P@ @ ) , but those changes were comparable to those seen with the NCEP milk-free diet ( all between-diet P@ @ ) .


Finally , the MILK diet was associated with lower VLDL apolipoprotein B fractional catabolic rate ( -@ % ; P = @ ) and plasma sterol concentrations ( -@ % ; P = @ ) compared with the control NCEP milk-free diet .


These data suggest that short-term consumption of low fat milk in the context of a prudent NCEP diet has no favorable nor deleterious effect on cardiometabolic risk factors associated with MetS in postmenopausal women with abdominal obesity .


Disturbances of the circadian rhythm of cortisol secretion are associated with depression , coronary calcification , and higher all-cause and cardiovascular mortality.The primary aim of this study was to test the associations between midnight salivary cortisol ( MSC ) , depression and HbA@c , and control for behavioural , environmental and intra individual factors with possible impact on cortisol secretion , like smoking , physical inactivity , season , medication , diabetes duration , severe hypoglycemia episodes , age and gender in patients with type @ diabetes .


Secondary aims were to present MSC levels for a reference group of non-depressed type @ diabetes patients with a healthy life style ( physically active and non-smoking ) , and to explore seasonal variations .


A cross-sectional population based study of @ patients ( @ % men and @ % women ) aged @-@ years that participated in a randomized controlled trial targeting depression in type @ diabetes .


Depression was assessed by the Hospital Anxiety and Depression Scale-depression subscale .


MSC , HbA@c , serum-lipids , blood pressure , waist circumference and data from medical records and the Swedish National Diabetes Registry were collected .


Thirty four patients ( @ % ) had MSC @ nmol/L , which was associated with smoking ( AOR @ ) , spring season ( AOR @ ) , physical inactivity ( AOR @ ) , self-reported depression ( AOR @ ) , and older age ( per year ) ( AOR @ ) .


HbA@c > @ mmol/mol ( > @ % ) ( AOR @ ) and MSC @ nmol/L ( AOR @ ) were independently linked to self-reported depression .


Season was strongly associated with MSC levels and no other variables studied showed seasonal variations .


In a reference group of @ non-depressed patients with a healthy life style ( physically active , non-smoking ) the median MSC level was @ nmol/L ( range @-@ @ ) .


In this study of patients with type @ diabetes high MSC was linked to smoking , physical inactivity , depression , season and older age .


Thus a high cortisol value identified three major targets for treatment in type @ diabetes .


To compare efficacy difference among wrist-ankle needle , body-acupuncture and ibuprofen in the treatment of primary dysmenorrhea .


Ninety-five cases were randomly divided into a wrist-ankle needle group ( @ cases ) , a body-acupuncture group ( @ cases ) and an ibuprofen group ( @ cases ) .


Acupunc - , ture at Lower @ and Lower @ area was applied in the wrist-ankle needle group .


Acupuncture at Guanyuan ( CV @ ) and Sanyinjiao ( SP @ ) were applied in the body-acupuncture group .


Ibuprofen sustained-release capsules were given for oral administration in the ibuprofen group .


The treatment began @ days before menses , once a day , until pain was relieved .


One menstrual cycle was taken as a treatment course , continuously for @ courses and efficacy were observed in three groups .


The symptom score of dysmenorrhea and visual analogue scale ( VAS ) were used to assess pain severity before and after treatment .


@The efficacy differences in three groups were statistically significant ( P < @ ) , in which the total effective rate was @ % ( @/@ ) in the wrist-ankle needle group , @ % ( @/@ ) in the body-acupuncture group and @ % ( @/@ ) in the ibuprofen group .


@ After the treatment , symptom score of dysmenorrhea and VAS were all obviously lower than that before the treatment in three groups ( all P < @ ) .


Compared with ibuprofen group ( @ + / -@ ) , after the treatment symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / -@ ) and body-acupuncture group ( @ + / -@ ) was obviously decreased ( P < @ , P < @ ) , and VAS in the wrist-ankle needle group was significantly reduced ( P < @ ) .


Compared with body-acupuncture group ( @ + / -@ ) , symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / - @ ) was obviously decreased ( P < @ ) .


The wrist-ankle needle has better effect than body acupuncture and ibuprofen on the treatment of primary dysmenorrhea , which could significantly improve dysmenorrhea symptoms .


To compare the anticoagulation effect of regional citrate and heparin in patients with sustained low-efficiency hemodialysis ( SLED ) .


This study was conducted in the teaching hospital of Sichuan University between November @ and January @.Sixty-three patients suffering from acute kidney injury or end-stage renal diseases ( ESRD ) were enrolled and further randomized to @ groups : citrate and heparin anticoagulation treatment groups in SLED .


SLED was conducted by Fresenius @sARrTplus dialyzer for @ hours each session , and blood flow was set at @ ml/min .


Prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) and platelet ( PLT ) count were analyzed .


Sixty-three patients underwent @ sessions of SLED .


Among them , @ patients ( @ % ) was discharged after treatment or converted to outpatient intermittent hemodialysis , and @ patients died of multiple organ failure during hospitalization .


Compared with that in the citrate group , both PT and APTT in heparin group was significantly higher -LSB- PT : ( @ @ ) s vs ( @ @ ) s , P < @ ; APTT : ( @ @ ) s vs ( @ @ ) s , P < @ ; respectively -RSB- at @ h during SLED.However , the PT and APTT levels in heparin group decreased afterwards and were similar with those in the citrate groups at @ h during treatment .


There is no difference on PLT counts between these two groups after treatment .


The anticoagulation effect of regional citrate and heparin was similar in patients when receiving SLED.Regional citrate may be an alternative anticoagulant approach for the patients at high risk of bleeding who require the treatment of SLED .


Uncontrolled intervention studies , including studies involving breast cancer survivors , have demonstrated improvements in vasomotor symptoms ( VMS ) after stellate ganglion blockade ( SGB ) with a local anesthetic .


This study presents the first randomized sham-controlled trial of SGB for the treatment of VMS .


Participants included @ postmenopausal women , aged @ to @ years , with moderate to severe VMS .


The study was a randomized sham-controlled trial comparing the effects of SGB versus sham injection on the frequencies of total and moderate to severe VMS , as measured by daily diaries .


Image-guided SGB was performed with @ mL of @ % bupivacaine .


Sham injection of saline was performed in subcutaneous tissues in the neck .


VMS were recorded at baseline and for @ months thereafter .


Objective VMS were recorded using ambulatory sternal skin conductance monitoring during a @-hour period at baseline and on @-month follow-up .


There were no significant group differences in overall VMS frequency , but the frequency of moderate to very severe VMS was reduced more in the active group compared with the sham treatment group ( event rate ratio , @ ; @ % CI , @-@ @ ; P < @ ) .


The frequency of objective VMS was also reduced to a greater degree in the SGB group than in the sham group ( event rate ratio , @ ; @ % CI , @-@ @ ; P < @ ) .


There were no study-related serious adverse events .


SGB may provide effective treatment of VMS in women who seek nonhormonal treatments because of safety concerns and personal preference .


The finding that SGB significantly reduces objectively measured VMS provides further evidence of efficacy .


A larger trial is warranted to confirm these findings .


Long-term adaptive servoventilation ( ASV ) increases cardiac function more effectively than continuous positive airway pressure ( CPAP ) , possibly via alleviation of sympathetic overactivation .


The present study evaluated the effect of ASV and CPAP at comparable pressure on muscle sympathetic nerve activity ( MSNA ) in patients with heart failure ( HF ) and with or without periodic breathing ( PB ) .


A total of @ patients with HF ( ejection fraction < @ ) were randomized to receive CPAP ( n = @ ) or ASV ( n = @ ) .


Respiratory profiles and MSNA were continuously monitored before and during CPAP and ASV ( @min ) at pressures of @ and @ cmH@O , respectively .


The severity of respiratory instability was determined using the coefficient of variation of tidal volume ( CV-TV ) .


Although heart rate and blood pressure remained unchanged , only ASV improved CV-TV .


MSNA decreased in the ASV ( P < @ ) , but not in the CPAP group .


The change in CV-TV independently predicted changes in MSNA ( P < @ ) .


Device type and PB significantly interacted with changes in MSNA ( P < @ ) and ASV exerted sympathoinhibitory effects in patients with PB , whereas CPAP did not .


A sympathoinhibitory effect in patients without PB was not evident in either treatment arm .


ASV probably exerts its sympathoinhibitory effects in patients with HF and PB through pressure support .


To determine the response , toxicities , and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced , or recurrent endometrial carcinoma .


Preclinical evidence suggested that blockade of the PI@K/AKT/mTOR pathway might overcome resistance to hormonal therapy .


We performed a randomized phase II trial of intravenous temsirolimus @mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate @ mg bid for three weeks alternating with tamoxifen @mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma .


There were @ eligible patients who received at least one dose of therapy with @ of these treated on the combination arm which was closed early because of an excess of venous thrombosis , with @ episodes of deep venous thrombosis ( DVT ) and @ pulmonary emboli .


There were three responses observed in that arm ( @ % ) .


A total of @ eligible patients were treated on the single agent arm with @ episodes of DVT and @ responses ( @ % ) .


Response rates were similar in patients with prior chemotherapy ( @ of @ ; @ % ) and those with no prior chemotherapy ( @ of @ ; @ % ) .


Two of four patients with clear cell carcinoma responded .


Adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis .


Temsirolimus activity was preserved in patients with prior adjuvant chemotherapy .


A link between poor sleep quality and Alzheimer 's disease ( AD ) has recently been suggested .


Since endogenous melatonin levels are already reduced at preclinical AD stages , it is important to ask whether replenishing the missing hormone would be beneficial in AD and whether any such effects would be related to the presence of sleep disorder in patients .


The effects of add-on prolonged-release melatonin ( PRM ) ( @ mg ) to standard therapy on cognitive functioning and sleep were investigated in @ patients ( men -LSB- @ % -RSB- , women -LSB- @ % -RSB- , average age @ years -LSB- range , @-@ years -RSB- ) diagnosed with mild to moderate AD , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine ) .


In this randomized , double-blind , parallel-group study , patients were treated for @ weeks with placebo and then randomized ( @:@ ) to receive @ mg of PRM or placebo nightly for @ weeks , followed by @ weeks placebo .


The AD Assessment Scale-Cognition ( ADAS-Cog ) , Instrumental Activities of Daily Living ( IADL ) , Mini-Mental State Examination ( MMSE ) , sleep , as assessed by the Pittsburgh Sleep Quality Index ( PSQI ) and a daily sleep diary , and safety parameters were measured .


Patients treated with PRM ( @ weeks ) had significantly better cognitive performance than those treated with placebo , as measured by the IADL ( P = @ ) and MMSE ( P = @ ) .


Mean ADAS-Cog did not differ between the groups .


Sleep efficiency , as measured by the PSQI , component @ , was also better with PRM ( P = @ ) .


In the comorbid insomnia ( PSQI @ ) subgroup , PRM treatment resulted in significant and clinically meaningful effects versus the placebo , in mean IADL ( P = @ ) , MMSE score ( +@ versus -@ points ) ( P = @ ) , and sleep efficiency ( P = @ ) .


Median ADAS-Cog values ( -@ versus +@ points ) ( P = @ ) were significantly better with PRM .


Differences were more significant at longer treatment duration .


PRM was well tolerated , with an adverse event profile similar to that of placebo .


Add-on PRM has positive effects on cognitive functioning and sleep maintenance in AD patients compared with placebo , particularly in those with insomnia comorbidity .


The results suggest a possible causal link between poor sleep and cognitive decline .


ARDS is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources .


Direct ARDS ( pneumonia , aspiration ) has been hypothesized to cause more severe lung epithelial injury than indirect ARDS ( eg , nonpulmonary sepsis ) ; however , this hypothesis has not been well studied in humans .


We measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of @ patients with ARDS and severe sepsis and in a secondary analysis of @ patients with ARDS drawn from a multicenter randomized controlled trial .


Biomarker levels in patients with direct vs indirect ARDS were compared in both cohorts .


In both studies , patients with direct ARDS had significantly higher levels of a biomarker of lung epithelial injury ( surfactant protein D ) and significantly lower levels of a biomarker of endothelial injury ( angiopoietin-@ ) than those with indirect ARDS .


These associations were robust to adjustment for severity of illness and ARDS severity .


In the multicenter study , patients with direct ARDS also had lower levels of von Willebrand factor antigen and IL-@ and IL-@ , markers of endothelial injury and inflammation , respectively .


The prognostic value of the biomarkers was similar in direct and indirect ARDS .


Direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury .


The opposite pattern was identified in indirect lung injury .


Clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ARDS , respectively .


This study aims to evaluate the effects of nasal packs on surgical success and related complications in septoplasty .


Thirty-eight patients ( @ males , @ females ; mean age , @ years , range @ to @ years ) were included in the study .


Septoplasty candidates were prospectively divided into two groups .


Nasal packing and transseptal suture technique was applied to patients in group @ ( n = @ ) and group @ ( n = @ ) , respectively .


Postoperative pain was assessed with the visual analog scale .


The success of surgery was questioned using the Nasal Obstruction Septoplasty Effectiveness ( NOSE ) scale .


Surgical success was defined as a @ % decrease in the NOSE scores .


There was no statistically significant difference in surgical success and complication rates between the groups ( p > @ ) .


Pain scores were significantly higher in group @ ( p = @ ) .


Our study results suggest that nasal pack use does not affect surgical success and complication rates in septoplasty .


Pack-free septoplasty with the transseptal suture technique is an effective method in the treatment of septal deviation .


To compare the nasal tube with face mask as interfaces for stabilization of very preterm infants at birth by using physiological measurements of leak , obstruction , and expired tidal volumes during positive pressure ventilation ( PPV ) .


In the delivery room , @ infants < @ weeks gestation were allocated to receive respiratory support by nasal tube or face mask .


Respiratory function , heart rate , and oxygen saturation were measured .


Occurrence of obstruction , amount of leak , and tidal volumes were compared using a Mann-Whitney U test or a Fisher exact test .


The first @ minutes after initiation of PPV were analyzed ( @ inflations in the nasal tube group and @ inflations in the face mask group ) .


Spontaneous breathing coincided with PPV in @ % of nasal tube and @ % of face mask inflations .


During inflations , higher leak was observed using nasal tube compared with face mask ( @ % -LSB- @ % -@ % -RSB- vs @ -LSB- @ % -@ % -RSB- ; P < @ ) .


Obstruction occurred more often ( @ % vs @ % ; P < @ ) .


Expired tidal volumes were significantly lower during inflations when using nasal tube compared with face mask ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- mL/kg ; P < @ ) and when spontaneous breathing coincided with PPV ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- mL/kg ; P < @ ) but were similar during breathing on continuous positive airway pressure ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- mL/kg ; P > @ ) .


Heart rate was not significantly different between groups , but oxygen saturation was significantly lower in the nasal tube group the first @ minutes after start of respiratory support .


The use of a nasal tube led to large leak , more obstruction , and inadequate tidal volumes compared with face mask .


To evaluate the efficacy and safety of ospemifene , a novel selective oestrogen receptor modulator , in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy ( VVA ) .


A @ week , multicentre , randomised , double-blind , parallel-group phase III study of women ( @-@ years ) with VVA and self-reported vaginal dryness as their most bothersome symptom .


The co-primary efficacy endpoints were the change from baseline to Week @ in ( @ ) percentage of parabasal cells in the maturation index ( MI ) , ( @ ) percentage of superficial cells in the MI , ( @ ) vaginal pH , and ( @ ) severity of vaginal dryness .


Safety assessments included physical examination , cervical Papanicolaou test and clinical laboratory analyses .


Endometrial thickness and histology was also assessed .


A total of @ women were randomised to once-daily ospemifene @ mg/day ( n = @ ) or placebo ( n = @ ) .


Significant improvements in the percentages of parabasal and superficial cells in the MI and vaginal pH were observed with ospemifene compared with placebo ( p < @ for all parameters ) .


The mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance ( p = @ ) .


Improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population .


The majority of treatment-emergent adverse events were considered mild to moderate in severity .


Once-daily oral ospemifene @ mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness .


Guidelines recommend lopinavir/ritonavir ( LPV/r ) as first - and second-line therapy for young and older HIV-infected children , respectively .


Available formulations have limitations making their widespread use complex .


An open-label comparative bioavailability ( randomized crossover ) study compared a novel twice-daily minitab sprinkle formulation ( @ mg/@ mg , Cipla Pharmaceuticals ) versus innovator syrup in HIV-infected Ugandan infants aged @ to < @ months ( cohort A ) and children aged @-@ years ( cohort B ) and versus Cipla tablets ( @/@ mg ) in children aged @ to < @ years ( cohort C ) .


Twelve-hour intensive pharmacokinetic sampling after observed LPV/r intake ( plus @ nucleoside reverse transcriptase inhibitors ) following World Health Organization @ dosing with food was performed @ weeks after enrollment .


Children then switched formulation ; sampling was repeated at week @ .


Acceptability data were also collected .


Seventy-seven infants/children were included in cohort A ( n = @ ) / B ( n = @ ) / C ( n = @ ) .


Among @ evaluable pharmacokinetic profiles , there were @/@/@ within-child comparisons in cohort A/B/C .


For minitabs versus syrup , geometric mean -LSB- @ % confidence interval ( CI ) -RSB- AUC@-@h was @ ( @-@ @ ) versus @ ( @-@ @ ) hmg/L in cohort A -LSB- geometric mean ratio ( GMR ) ( @ % CI ) = @ ( @ to @ ) -RSB- and @ ( @ to @ ) versus @ ( @ to @ ) hmg/L in cohort B -LSB- GMR ( @ % CI ) = @ ( @ to @ ) -RSB- .


For minitabs versus tablets , geometric mean ( @ % CI ) AUC@-@h was @ ( @ to @ ) versus @ ( @ to @ ) hmg/L ; GMR ( @ % CI ) = @ ( @ to @ ) .


Subtherapeutic levels ( < @ mg/L ) occurred in @ ( @ % ) / @ ( @ % ) minitabs/syrup in infants ( P = @ ) , no children aged @-@ years and @ ( @ % ) / @ ( @ % ) minitabs/tablets ( P = @ ) .


About @/@ ( @ % ) and @/@ ( @ % ) caregivers of infants and children aged @-@ years , respectively , chose to continue minitabs after week @ , mainly for convenience ; only @/@ ( @ % ) older children ( five < @ years ) remained on minitabs .


LPV/r exposure from minitabs was comparable with syrup , but lower than tablets , with no significant differences in subtherapeutic concentrations .


Minitabs were more acceptable than syrups for younger children , but older children preferred tablets .


Mindfulness-based interventions may be acceptable to veterans who have poor adherence to existing evidence-based treatments for posttraumatic stress disorder ( PTSD ) .


To compare mindfulness-based stress reduction with present-centered group therapy for treatment of PTSD .


Randomized clinical trial of @ veterans with PTSD recruited at the Minneapolis Veterans Affairs Medical Center from March @ to December @ .


Outcomes were assessed before , during , and after treatment and at @-month follow-up .


Data collection was completed on April @ , @ .


Participants were randomly assigned to receive mindfulness-based stress reduction therapy ( n = @ ) , consisting of @ sessions ( @ weekly @-hour group sessions and a daylong retreat ) focused on teaching patients to attend to the present moment in a nonjudgmental , accepting manner ; or present-centered group therapy ( n = @ ) , an active-control condition consisting of @ weekly @-hour group sessions focused on current life problems .


The primary outcome , change in PTSD symptom severity over time , was assessed using the PTSD Checklist ( range , @-@ ; higher scores indicate greater severity ; reduction of @ or more considered a minimal clinically important difference ) at baseline and weeks @ , @ , @ , and @ .


Secondary outcomes included PTSD diagnosis and symptom severity assessed by independent evaluators using the Clinician-Administered PTSD Scale along with improvements in depressive symptoms , quality of life , and mindfulness .


Participants in the mindfulness-based stress reduction group demonstrated greater improvement in self-reported PTSD symptom severity during treatment ( change in mean PTSD Checklist scores from @ to @ vs @ to @ with present-centered group therapy ; between-group difference , @ ; @ % CI , @-@ @ ; P = @ ) and at @-month follow-up ( change in mean scores from @ to @ vs @ to @ , respectively ; difference , @ ; @ % CI , @-@ @ , P < @ ) .


Although participants in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported PTSD symptom severity ( @ % vs @ % with present-centered group therapy ; difference , @ % ; @ % CI , @ % -@ % ; P = @ ) at @-month follow-up , they were no more likely to have loss of PTSD diagnosis ( @ % vs @ % , respectively ; difference , @ % ; @ % CI , -@ % to @ % ; P = @ ) .


Among veterans with PTSD , mindfulness-based stress reduction therapy , compared with present-centered group therapy , resulted in a greater decrease in PTSD symptom severity .


However , the magnitude of the average improvement suggests a modest effect .


The relationship between tobacco and cannabis use is strong .


When co-smokers try to quit only one substance , this relationship often leads to a substitution effect , that is , the increased use of the remaining substance .


Stopping the use of both substances simultaneously is therefore a reasonable strategy , but co-smokers rarely report feeling ready for simultaneous cessation .


Thus , the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen .


To reach as many co-smokers as possible , we developed brief Web-based interventions aimed at enhancing the readiness to simultaneously quit tobacco and cannabis use .


Our aim was to analyze the efficacy of three different Web-based interventions designed to enhance co-smokers ' readiness to stop tobacco and cannabis use simultaneously .


Within a randomized trial , three brief Web-based and fully automated interventions were compared .


The first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized , normative feedback .


The second intervention was based on principles of motivational interviewing .


As an active psychoeducational control group , the third intervention merely provided information on tobacco , cannabis , and the co-use of the two substances .


The readiness to quit tobacco and cannabis simultaneously was measured before and after the intervention ( both online ) and @ weeks later ( online or over the phone ) .


Secondary outcomes included the frequency of cigarette and cannabis use , as measured at baseline and after @ weeks .


A total of @ website users were assessed for eligibility based on their self-reported tobacco and cannabis co-use , and @ participants were ultimately randomized and analyzed .


For the post-intervention assessment , generalized estimating equations revealed a significant increase in the readiness to quit tobacco and cannabis in the total sample ( B = @ , @ % CI @-@ @ , P = @ ) .


However , this effect was not significant for the comparison between baseline and the @-week follow-up assessment ( P = @ ) .


Furthermore , no differential effects between the interventions were found , nor were any significant intervention or time effects found on the frequency of tobacco or cannabis use .


In the new field of dual interventions for co-smokers of tobacco and cannabis , Web-based interventions can increase the short-term readiness to quit tobacco and cannabis simultaneously .


The studied personalized techniques were no more effective than was psychoeducation .


The analyzed brief interventions did not change the secondary outcomes , that is the frequency of tobacco and cannabis use .


To evaluate the clinical effects of Yuleshu oral mixture combined with conventional therapy on chronic prostatitis .


Eighty-eight patients with chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) were equally randomized to a control and an experimental group to receive conventional therapy ( oral antibiotics , alpha blockers , proprietary Chinese medicine for activating blood circulation and massage of the prostate ) and conventional therapy combined with Yuleshu oral mixture respectively .


Before and after treatment , the severity of symptoms and sexual function of the patients were evaluated using NIH-CPSI and IIEF-@ , their anxiety , depression and other emotional problems assessed with Hamilton Depression Rating Scale ( HAMD ) and Hamilton Anxiety Scale ( HAMA ) , and the results subjected to statistical analysis .


Both the experimental and control groups showed significant improvement in prostatitis symptoms and sexual function after treatment as compared with the baseline ( P < @ ) , even more significant in the former than in the latter group , especially in pain symptoms ( @ + / - @ vs @ + / - @ , P < @ ) .


Before and after treatment , the HAMA and HAMD score had no significant difference in the control , but there was significant difference in the experimental group .


The experimental group exhibited remarkably higher scores after than before treatment on HAMA ( @ + / - @ vs @ + / - @ , P < @ ) and HAMD ( @ + / - @ vs @ + / - @ , P < @ ) , but not the control group ( P > @ ) .


Yuleshu oral mixture can effectively relieve anxiety , depression and other psychological problems in CP/CPPS patients , and improve their clinical symptoms as well .


Therefore , it is an effective drug for chronic prostatitis .


To investigate clinical efficacy and safety of @ certolizumab pegol ( CZP ) maintenance dosing regimens plus methotrexate ( MTX ) in active rheumatoid arthritis ( RA ) patients achieving the American College of Rheumatology @ % improvement criteria ( ACR@ ) after the CZP @ mg every @ weeks open-label run-in period .


DOSEFLEX ( dosing flexibility ) was a double-blind , placebo-controlled randomized study with an open-label run-in phase .


During the run-in phase , all patients received CZP @ mg ( weeks @ , @ , and @ ) and @ mg every @ weeks to week @ .


Week @ ACR@ responders were randomized @:@:@ at week @ to CZP @ mg every @ weeks , @ mg every @ weeks , or placebo .


A total of @ ( of @ ) patients were randomized at week @ ( CZP : @ mg , n = @ ; @ mg , n = @ ; placebo , n = @ ) .


Groups had similar baseline characteristics ( week @ ) .


Week @ ACR@ response rates were comparable between the CZP @ mg every @ weeks and the @ mg every @ weeks groups ( @ % versus @ % ) , which was significantly higher than placebo ( @ % ; P = @ and P = @ ) .


ACR@/@ and remission criteria were met more frequently in CZP groups than placebo at week @ , with similar responses between anti-tumor necrosis factor-experienced and naive patients .


Improvements from baseline Disease Activity Score in @ joints using the erythrocyte sedimentation rate and Health Assessment Questionnaire disability index scores were maintained in CZP groups from week @ to @ while worsening on placebo .


Adverse event ( AE ) rates in the double-blind phase were @ % versus @ % versus @ % ; serious AE rates were @ % versus @ % versus @ % ( CZP @ mg , @ mg , and placebo groups ) .


In active RA patients with an incomplete MTX response , CZP @ mg every @ weeks and @ mg every @ weeks were comparable and better than placebo for maintaining clinical response to week @ following a @-week , open-label run-in phase .


The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing .


The study was designed as a randomized , double-blind , placebo-controlled trial .


Outpatient children aged @ to @ years with at least @ episode of viral wheezing in the last @ months , presenting to any of @ Italian pediatricians for an upper respiratory tract infection , were randomly allocated to receive beclomethasone @ g or placebo twice daily for @ days .


Medications were administered through a nebulizer .


A clinical evaluation was performed by the pediatrician at the start and end of the treatment period .


A subjective evaluation of symptoms and efficacy of treatment was performed by the parents .


The primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the @-day treatment period .


A total of @ children were enrolled in the study , @ of whom were visited at the end of the treatment period .


Wheezing was diagnosed by the pediatricians in @ children ( @ % -LSB- @ % confidence interval : @ to @ -RSB- ) , with no statistically significant differences between treatment groups ( beclomethasone versus placebo relative risk : @ -LSB- @ % confidence interval : @ to @ -RSB- ) .


The treatment was considered helpful by @ % of parents ( @ % in the beclomethasone group vs @ % in the placebo group ) .


In all , @ % of children still had infection symptoms at the end of the treatment period , with no differences between groups .


The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing .


Moreover , no benefits were found in reducing symptoms of respiratory tract infections .


To examine the effect of repeated-sprint training ( RST ) vs combined RST and resistance training with superimposed vibrations on repeated-sprint ability ( RSA ) and lower-body power output in male rugby players .


Players were divided into @ training groups .


One group performed RST ( n = @ ) @ d/wk and the other performed RST @ d/wk and squat resistance training with superimposed vibrations on the second day ( RS+ST ; n = @ ) .


The squat training was carried out with a volume similar ( ie , number of sets and repetitions ) to that of the RST .


The training period lasted @ wk , and it was carried out as a supplement to the regular rugby training sessions .


Substantial improvements in RSA mean time ( RSA ( mean ) ; +@ % / ES : @ vs +@ % / ES : @ ) , RSA percent decrement ( % Dec ; -@ % / ES : @ vs -@ % / ES : @ ) , and squat absolute power output ( +@ % / ES :@ vs +@ % / ES : @ ) were obtained in RST and RS+ST , respectively .


Substantial improvements in RSA best time ( RSA ( best ) ; +@ % / ES : @ ) and squat power output normalized to body mass ( +@ % / ES : @ ) only occurred in RS+ST .


Both pretest and posttest RSA ( mean ) were largely correlated with the RSA ( best ) .


However , there were only unclear , small to moderate correlations between individual changes in squat power output and either RSA ( mean ) or RSA ( best ) .


Combined RST and resistance training induced improvements of greater magnitude in both repeated-sprint performance and muscle power output than the RST alone .


The lack of substantial correlations between individual changes in repeated-sprint and muscle-power performance suggests that the same subjects were not systematically low or high responders to both RST and strength training .


The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China ( ClinicalTrials.gov NCT@ ) .


After obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study .


Included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth .


Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods .


Fissure status of the molars in each group was evaluated every @ months .


Development of dentine caries and sealant retention over @ months in the molars in the two sealant-using groups was compared in this report .


Outcome on cost-effectiveness of all four groups over @ months will be reported elsewhere .


At baseline , a total of @ children ( @ molars ) with mean age @ years were involved for the two sealant groups .


After @ months , @ children ( @ molars ) were followed .


Proportions of molars with dentine caries were @ % and @ % in the ART sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = @ ) .


Life-table survival analysis showed that sealant retention ( full and partial ) rate over @ months for the resin sealant ( @ % ) was significantly higher than that ( @ % ) for the ART sealant ( p < @ ) .


Molar survival ( no development of dentine caries ) rates in the ART sealant ( @ % ) and fluoride-releasing resin sealant ( @ % ) groups were not significantly different ( p = @ ) .


Multilevel logistic regression ( GEE modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding .


Though the retention of fluoride-releasing resin sealant was better than that of the ART sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over @ months .


ART sealants could be a good alternative when and where resources for resin sealant placement are not readily available .


Introduction of calcineurin inhibitors had led to improved survival rates in liver transplant recipients .


However , long-term use of calcineurin inhibitors is associated with a higher risk of chronic renal failure , neurotoxicity , de novo malignancies , recurrence of hepatitis C viral ( HCV ) infection and hepatocellular carcinoma .


Several studies have shown that everolimus has the potential to provide protection against viral replication , malignancy , and progression of fibrosis , as well as preventing nephrotoxicity by facilitating calcineurin inhibitor reduction without compromising efficacy .


The Hephaistos study evaluates the beneficial effects of early initiation of everolimus in de novo liver transplant recipients .


Hephaistos is an ongoing @-month , multi-center , open-label , controlled study aiming to enroll @ de novo liver transplant recipients from @ centers across Germany .


Patients are randomized in a @:@ ratio ( @-@days post-transplantation ) to receive everolimus ( trough levels @-@ng / mL ) with reduced tacrolimus ( trough levels < @ng/mL ) , or standard tacrolimus ( trough levels @-@ng / mL ) after entering a run-in period ( @-@days post-transplantation ) .


In the run-in period , patients are treated with induction therapy , mycophenolate mofetil , tacrolimus , and corticosteroids according to local practice .


Randomization is stratified by HCV status and model of end-stage liver disease scores at transplantation .


The primary objective of the study is to exhibit superior renal function ( estimated glomerular filtration rate assessed by the Modification of Diet in Renal Disease ( MDRD ) -@ formula ) with everolimus plus reduced tacrolimus compared to standard tacrolimus at Month @ .


Other objectives are : to assess the incidence of treated biopsy-proven acute rejection , graft loss , or death ; the incidences of components of the composite efficacy endpoint ; renal function via estimated glomerular filtration rate using various formulae ( MDRD-@ , Nankivell , Cockcroft-Gault , chronic kidney disease epidemiology collaboration and Hoek formulae ) ; the incidence of proteinuria ; the incidence of adverse events and serious adverse events ; the incidence and severity of cytomegalovirus and HCV infections and HCV-related fibrosis .


This study aims to demonstrate superior renal function , comparable efficacy , and safety in de novo liver transplant recipients receiving everolimus with reduced tacrolimus compared with standard tacrolimus .


This study also evaluates the antiviral benefit by early initiation of everolimus .


To compare the hemostatic effects of local packing of Nasopore combined with hemocoagulase injection and local packing of Nasopore combined with saline injection for postoperative management of functional endoscopic sinus surgery by a double-blind , randomized control clinical trial .


Sixty-eight cases of chronic sinusitis needed functional endoscopic sinus surgery were randomly divided into the experimental group of @ cases and control group of @ cases , respectively .


For the experimental group , @ U of hemocoagulase dissolved in @ ml saline was injected into Nasopore which was packed into the nasal cavity after operation .


For the control group , @ ml of saline was injected .


The postoperative bleeding of the two groups were scored by visual analogue scale .


There was statistically significant difference between the bleeding VAS scores assessed @ hours and the ones assessed @ , @ and @ days after the operation in the control group ( P < @ ) .


There was the statistically significant difference between the bleeding VAS scores of experimental group and control group assessed @ h after the operation ( P < @ ) .


The hemocoagulase may improve the hemostatic effect of Nasopore @ hours after the operation by combined injection with Nasopore as nasal cavity packing .


To follow up on a recent report from our lab -LSB- Hum Psychopharmacol @:@ -@ , @ . -RSB-


we examined the effects of caffeine on salivary - amylase ( sAA ) activity in response to an engaging , non-stressful task in healthy young males ( age @-@ yrs ) who consumed caffeine on a daily basis .


Using a placebo-controlled , double-blind , between-subjects design , @ men received either placebo , @ mg or @ mg of caffeine ( Vivarin ) .


Participants then rested for @ minutes , and performed a @-minute computerized air traffic controller-like task that was cognitively engaging but not stressful .


Saliva samples ( assayed for sAA and cortisol ) , blood pressure , and heart rate were taken before ( baseline ) and @ minutes after the computerized task .


Systolic and diastolic blood pressure and sAA activity increased across the laboratory session ( F 's > @ , p 's < @ ) ; salivary cortisol levels decreased ( F = @ , p < @ ) .


There were no main effects for caffeine administration on sAA , salivary cortisol , or cardiovascular measures , and caffeine did not interact with the task to alter these measures .


Laboratory administered caffeine does not alter sAA activity , even when sAA activity is stimulated by participating in a cognitively engaging task .


These data demonstrate that caffeine administration does not affect sAA activity , at least in healthy young men who regularly consume caffeine .


Results support recent findings that basal caffeine levels in habitual caffeine users are not associated with basal sAA activity and that daily caffeine intake and diurnal sAA activity are not related .


The present randomized , two-period , cross-over bioequivalence study compared two soft capsules of etoposide ( test and reference formulations ) , in treating @ advanced lung cancer patients .


The pharmacokinetic parameters were determined based on the concentrations of etoposide , using HPLC with fluorescence detector .


In each of the two study periods , a single dose of test or reference product was administered .


The pharmacokinetic parameters assessed included area under the plasma concentration-time curve ( AUC ( @-@h ) ) from @ to @ hours , AUC ( @-T ) from time zero to infinity , the peak plasma concentration of the drug ( C ( max ) ) , time to achieve C ( max ) , and the elimination half-life .


Comparison of the test and reference products containing etoposide showed that geometric mean ratios ( @ % confidence interval ( CI ) ) of AUC ( @-T ) , AUC ( @ - ) , and C ( max ) were @ % ( @ - @ % ) , @ % ( @ - @ % ) , and @ % ( @ - @ % ) , respectively .


Both AUC and C ( max ) ratio @ % CI of test and reference formulations were within its acceptable range for bioequivalence .


The values of tmax and t@/@ were not found to have a statistically significant difference between the test and the reference drug ( p > @ ) .


No adverse events occurred in this bioequivalence study .


The two etoposide soft capsules ( the test and reference formulations ) were bioequivalent .


Low-dose acetylsalicylic acid ( ASA ; aspirin ) for secondary prevention reduces cardiovascular disease mortality risk .


ASA acetylates cyclooxygenase in the portal circulation and is rapidly ( half-life , @ min ) hydrolyzed .


Certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover , a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediate-release ( IR ) ASA .


A once-daily , extended-release ( ER ) ASA formulation using ER microcapsule technology was developed to release ASA over the @-h dosing interval and reduce maximal plasma concentrations to spare peripheral endogenous endothelial prostacyclin production .


Healthy adults ( n = @ ) were randomized in a crossover study to receive two different ER-ASA single doses ( up to @ mg ) and two different IR-ASA single doses ( up to @ mg ) in four periods , each separated by @ days .


Pharmacodynamics was assessed by measuring serum thromboxane B@ ( TXB@ ) , urine @-dehydro-TXB@ , and arachidonic acid-induced platelet aggregation .


Pharmacokinetics was determined for ASA and salicylic acid ( SA ) .


Both formulations produced dose-dependent inhibition on all pharmacodynamic parameters .


Marked inhibition of TXB@ and @-dehydro-TXB@ was maintained over the @-h dosing interval after a dose of @ mg ER-ASA or @ mg IR-ASA .


The dose required to achieve @ % of maximum TXB@ inhibition with ER-ASA was @ mg versus @ mg for IR-ASA , for a similar maximum pharmacodynamic effect ( @ % TXB@ inhibition ) .


This suggests that an approximately twofold greater ER-ASA dose ( @ mg ) is necessary to obtain the same response as that of IR-ASA @ mg .


Peak ASA concentrations were lower and Tmax was longer with ER-ASA versus IR-ASA .


Administration of IR-ASA resulted in a dose-normalized mean Cmax of ASA that was approximately sixfold higher than that for ER-ASA and a Cmax of SA approximately two - to threefold higher than that for ER-ASA .


Both ASA formulations showed dose-dependent antiplatelet activity .


Compared with the IR-ASA , ER-ASA released active drug more slowly , resulting in prolonged absorption and lower systemic drug concentrations , which is expected for an ER ( @-h ) formulation .


In our hospital , lumbar epidural analgesia had been used for postoperative analgesia following vaginal total hysterectomy ( VTH ) .


But some patients experienced severe abdominal pain or numbness of the legs .


Therefore we planned a randomized prospective study to compare lower thoracic epidural analgesia and lumbar epidural analgesia following VTH .


Fifty patients were allocated to two groups : those who received lower thoracic epidural analgesia ( T group ) and the other who received lumbar epidural analgesia ( L group ) .


Both groupsreceived the same continuous epidural analgesia using fentanyl and ropivacaine after the operation .


The T group required significantly lower frequency of analgesic agents compared with that of the L group ( @ times vs. @ times , P < @ ) .


Fewer patients in the T group had felt numbness in their legs compared to the L group ( @ % vs. @ % , P < @ ) .


Lower thoracic epidural analgesia is more effective to provide postoperative analgesic effect following VTH compared with lumbar epidural analgesia .


To evaluate changes in corneal epithelial and stromal thickness after corneal collagen cross-linking ( CXL ) in eyes with keratoconus and postoperative corneal ectasia using spectral-domain optical coherence tomography ( SD-OCT ) .


Anterior segment SD-OCT ( RTVue-@ ; Optovue , Inc. , Fremont , CA ) was used to compare regional corneal epithelial and stromal thickness in eyes with keratoconus and ectasia before CXL and @ and @ months after CXL .


The anterior surface of the cornea , epithelium-Bowman 's layer interface , and posterior reflective surface were used as anatomical landmarks to measure epithelial and stromal thickness , respectively .


Regional thickness was assessed centrally and at @ points @ mm apart across the central @ mm of the corneal vertex in the horizontal and vertical meridians .


Thirty-one eyes from @ patients were evaluated , including @ eyes ( @ patients ) with keratoconus and @ eyes ( @ patients ) with ectasia .


Preoperatively , a highly irregular epithelial thickness profile and distribution was observed in both groups .


After CXL , epithelial thickness was significantly thinner @ and @ mm below and @ mm above the corneal apex ( @ @ m ; range : @ to @ m ) , and @ and @ mm nasal and @ mm temporal to the corneal apex ( @ @ m ; range : @ to @ m ) compared to preoperative values ( P < @ for all measurements ) .


Epithelial thickness standard deviations were significantly lower ( by @ to @ m ) @ months after CXL , compared to ranges before CXL in both the vertical and horizontal meridians for keratoconus and ectasia ( P = @ ) .


No significant differences were found between epithelial remodeling in keratoconus and corneal ectasia ( P = @ ) .


No significant or consistent stromal changes were found for either group .


Significant epithelial remodeling occurs after CXL in eyes with keratoconus and corneal ectasia , creating a similar , more regularized thickness profile in all meridians in the early postoperative period .


This pattern of remodeling may facilitate interpretation of corneal curvature and thickness changes after CXL and may be related to visual acuity after CXL .


Second-generation everolimus-eluting stents ( EES ) and third generation biolimus-eluting stents ( BES ) have been shown to be superior to first-generation paclitaxel-eluting stents ( PES ) and second-generation sirolimus-eluting stents ( SES ) .


However , neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent ( DES ) implantation overall .


The Absorb ( Abbott Vascular , Abbott Park , IL , USA ) is the first CE approved DES with a bioresorbable vascular scaffold ( BVS ) thought to reduce long-term complication rates .


The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion .


The EVERBIO II trial is a single-center , assessor-blinded , randomized trial .


The study population consists of all patients aged@ years old undergoing percutaneous coronary intervention .


Exclusion criterion is where the lesion can not be treated with BVS ( reference vessel diameter > @ mm ) .


A total of @ patients will be enrolled and randomly assigned into @ groups of @ with either BVS , EES or BES implantation .


All patients will undergo a follow-up angiography study at @ months .


Clinical follow-up for up to @ years will be conducted by telephone .


The primary endpoint is in-segment late lumen loss at @ months measured by quantitative coronary angiography .


Secondary endpoints are patient-oriented major adverse cardiac event ( MACE ) ( death , myocardial infarction and target-vessel revascularization ) , device-oriented MACE ( cardiac death , myocardial infarction and target-lesion revascularization ) , stent thrombosis according to ARC and binary restenosis at follow-up @ months angiography .


EVERBIO II is an independent , randomized study , aiming to compare the clinical efficacy , angiographic outcomes and safety of BVS , EES and BES in all comer patients .


To provide broader protection against pneumococcal disease , new vaccines containing conserved Streptococcus pneumoniae proteins are being developed .


This study assessed the safety , reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid ( dPly ) and histidine triad protein ( PhtD ) in toddlers .


In this phase II , multicenter , observer-blind study ( www.clinicaltrials.gov : NCT@ ) conducted in the Czech Republic , toddlers ( @-@ months ) were randomized ( @:@:@:@:@ ) to receive one of four investigational vaccine formulations ( @ or @g each of dPly and PhtD , alone or in combination with polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine -LSB- PHiD-CV -RSB- ) , or the licensed PHiD-CV , in a @-dose primary series plus booster at study months @ , @ and @ .


Solicited local and general symptoms were recorded within seven days post-vaccination , unsolicited symptoms within @ days post-vaccination , and serious adverse events ( SAEs ) during the entire study period .


Antibody concentrations against the vaccine components were measured pre-vaccination , one month post-dose @ , pre - and one month post-booster .


@ toddlers were enrolled and vaccinated .


Percentages of solicited local and general symptoms following the different investigational formulations were generally within the same ranges as for PHiD-CV .


After each dose , grade @ fever ( > @ C , rectal measurement ) was reported for maximum one toddler in each group with no differences between investigational formulations and PHiD-CV during primary vaccination .


@ SAEs were reported for @ toddlers , with distribution balanced between all groups except the group receiving @ g dPly/PhtD with PHiD-CV-conjugates ( no SAEs reported ) .


None of the SAEs were considered to be vaccine-related .


For all pneumococcal protein-containing formulations , anti-PhtD and anti-Ply antibody geometric mean concentrations increased from pre-vaccination to post-dose @ and from pre - to post-booster vaccination .


All investigational vaccine formulations were well-tolerated and immunogenic when administered to toddlers as a @-dose primary vaccination followed by a booster dose .


The purpose of this study was to evaluate a personalized protocol with diluted contrast material ( CM ) for coronary computed tomography angiography ( CTA ) .


One hundred patients with suspected coronary artery disease underwent retrospective electrocardiogram-gated coronary CTA on a @-slice multidetector-row CT scanner .


In the diluted CM protocol ( n = @ ) , the optimal scan timing and CM dilution rate were determined by the timing bolus scan , with @ % CM dilution ( @ml/s during @s ) being considered suitable to achieve the target arterial attenuation of @ Hounsfield units ( HU ) .


In the body weight ( BW ) - adjusted protocol ( n = @ , @mg iodine/kg ) , only the optimal scan timing was determined by the timing bolus scan .


The injection rate and volume in the timing bolus scan and real scan were identical between the @ protocols .


We compared the means and variations in coronary attenuation between the @ protocols .


Coronary attenuation ( meanSD ) in the diluted CM and BW-adjusted protocols was @ HU and @ HU , respectively .


The diluted CM protocol provided significantly higher coronary attenuation and lower variance than did the BW-adjusted protocol ( P < @ , in each ) .


The diluted CM protocol facilitates more uniform attenuation on coronary CTA in comparison with the BW-adjusted protocol .


Technological innovations in dental materials have been fueled by the desire of patients to improve the esthetics of their teeth .


This emphasis on esthetics has led dentists to seek resources that respect the standards established by society , but without compromising the integrity of the teeth .


The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with @ % and @ % hydrogen peroxide using home kits with whitening strips .


Adolescents aged @ to @ years will be allocated to different groups based on treatment ( n = @ per group ) : ( @ ) placebo ; ( @ ) @ % hydrogen peroxide ( White Class with Calcium , FGM ) ; ( @ ) @ % hydrogen peroxide ( White Class with Calcium , FGM ) ; and ( @ ) @ % hydrogen peroxide ( Oral B @D White , Oral-B ) .


After the whitening procedures , the participants will be evaluated using a visual analog scale for tooth sensitivity and digital spectrophotometry to measure changes in color .


Descriptive analysis of the data will be performed .


Either the chi-squared test or Fisher 's exact test will be used for the determination of associations among the categorical variables .


Student 's t-test and analysis of variance will be used to compare mean colorimetric data .


Pearson 's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables .


This randomized trial will provide an opportunity to evaluate products such as whitening strips in comparison to other self-administered methods , especially in adolescents .


Hypertension treatments include sodium restriction , pharmacological management , and lifestyle modifications .


Although many cases of hypertension can be controlled by medication , individuals may experience side effects or incur out-of-pocket expenses , and some may not comply with the treatment regimen .


Although some previous studies have shown a favorable effect for qigong on hypertension , well-designed , rigorous trials evaluating the effect of qigong on hypertension are scarce .


This study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized , clinical trial ( RCT ) .


Participants were randomized to a qigong group or an untreated control group .


This study was conducted at the Oriental Medical Center of Dongeui University , in the Republic of Korea .


Participants were individuals between the ages of @ and @ y with systolic blood pressure ( SBP ) between @ and @ mm Hg and/or diastolic blood pressure ( DBP ) between @ and @ mm Hg .


The qigong group attended qigong classes @ / wk and performed qigong at home at least @ / wk .


Participants in the control group did not receive any intervention for hypertension .


Outcome measures for this study were ( @ ) changes in blood pressure ( BP ) ; ( @ ) quality of life ( QOL ) using @ surveys : the Medical Outcomes Study ( MOS ) @-item short form ( SF-@ ) ( Korean version ) and the Measure Yourself Medical Outcome Profile @ ( MYMOP@ ) ; and ( @ ) hormone levels .


Of @ participants , @ were randomly assigned to the qigong group , and @ were assigned to the control group .


After @ wk , significant differences were observed between the qigong and the control groups regarding changes in SBP ( P = @ ) and DBP ( P = @ ) .


Among the categories of the MYMOP@ questionnaire , only wellbeing was significantly different between the @ groups ( P = @ ) .


The qigong group showed a significantly greater improvement in the physical component score of the SF-@ compared with the control group ( P = @ ) .


Regarding changes in hormone levels , there was no significant difference between the qigong and the control groups .


This pilot study demonstrates that regarding sample size , a RCT evaluating the effect of qigong on hypertension should include @ participants based on DBP and @ participants based on SBP in each group , thus allowing for a loss to follow-up rate of @ % .


The results indicate that qigong may be an effective intervention in reducing BP in prehypertension and mild hypertension .


Further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on BP .


The metabolic variability and response to acute systematic hypoxia have been characterized by the high resolution of liquid chromatography/time-of-flight/mass spectrometry ( LC-TOF/MS ) in this study .


Specifically , we compared the urinary metabolic profiles of six healthy sedentary men under normoxia ( @ % O@ ) with acute systematic hypoxic conditions of @ % ( equivalent to about @ m in altitude ) and @ % O@ ( equivalent to about @ m in altitude ) for @ h in a normobaric hypoxia chamber .


A clear separation of dose-dependent responses was visualized by Partial Least Squares Discriminant Analysis ( PLS-DA ) between normoxic and hypoxic conditions .


Over one thousand features were found in this study , about @ % of which showed significant change from hypoxia treatment and @ metabolites were identified ; however , there is great variability in metabolite concentrations among the @ subjects , which reflects the diversity of human systems .


Within the variability , we found that @-methyladenosine and @-methylthioadenosine are conspicuously upregulated ; on the other hand , @-inodoleacetic acid and L-glutamic acid were downregulated .


The increase in purine metabolic products ( uric acid , xanthine , and hypoxathine ) results from hypoxia ; this increase can be used as a marker for the hypoxic condition .


@-Methyladenosine was also highly upregulated from MH to SH and may be a very sensitive biomarker that reflects cellular hypoxia , due to its potential connection to HIF-@ .


The increase of free carnitine and acetyl carnitines , on the other hand , signals a change in the pathway of energy , or lipid , metabolism .


There is still no gold standard technique for graft fixation during anterior cruciate ligament reconstruction .


We compared the functional outcomes of patients receiving either ToggleLoc with ZipLoop technology or Translig transverse crosspin device for femoral graft fixation .


A total of @ patients were randomly allocated into two groups to receive either Translig ( ) transverse crosspin ( Translig group @ : n = @ , mean age @ years , age @-@years ) or ToggleLoc with ZipLoop technology ( ToggleLoc group : n = @ , mean age @ , age @-@years ) for femoral graft fixation .


Early and @-year assessment was made with Lysholm knee scale , International Knee Documentation Committee Scoring , Tegner Activity Level Scale , KT-@ arthrometer and pivot shift test .


Preoperative vs. postoperative functional parameters showed significant improvement in both groups .


Two groups were similar in terms of Lysholm knee scale , IKDC and Tegner activity scores ( p > @ ) .


The KT-@ arthrometer revealed slightly less anterior sliding in Translig group than that in ToggleLoc group ( p > @ ) .


ToggleLoc technique allowed a radiographically more horizontal placement of the graft than Translig technique .


Two distinct techniques used in this study are likely to be suitable for femoral graft fixation during anterior cruciate ligament reconstruction with the femoral tunnel being created via anteromedial approach .


Antibody-mediated rejection ( AMR ) is a severe form of rejection , mediated primarily by antibody-dependent complement ( C ) activation .


C@ inhibitor ( C@-INH , Berinert ) inhibits the classical and lectin pathways of C activation .


We performed a randomized , placebo-controlled study using C@-INH in highly sensitized renal transplant recipients for prevention of AMR .


Twenty highly sensitized patients desensitized with IVIG + rituximabplasma exchange were enrolled and randomized @:@ to receive plasma-derived human C@-INH ( @ IU/kg/dose ) versus placebo intraoperatively , then twice weekly for @ doses .


Renal function , adverse events ( AEs ) / serious AEs , C@ , C@ , and C@-INH levels were monitored and C@q + HLA antibodies were also blindly assessed .


One patient in the C@-INH group versus @ patients in the placebo group developed serious AEs , but none were related to study drug .


Delayed graft function developed in @ C@-INH subject and @ in the placebo .


The C@-INH trough levels increased with C@-INH treatment .


C@ and C@ levels also increased significantly in the C@-INH group compared to placebo .


No C@-INH patient developed AMR during the study .


Two patients developed AMR after the study .


Three placebo patients developed AMR , one during the study .


C@q + donor specific antibodies were reduced in @ C@-INH treated patients tested , while immunoglobulin G DSA levels showed decreased binding for both groups .


The C@-INH appears safe in the posttransplant period .


The C@-INH treatment may reduce ischemia-reperfusion injury .


The C@-INH also resulted in significant elevations of C@-INH levels , C@ , C@ , and reduced C@q + HLA antibodies .


Taken together , the combination of antibody reduction and C@-INH may prove useful in prevention of AMR .


Further controlled studies are warranted .


Invasive candidiasis in premature infants causes death and neurodevelopmental impairment .


Fluconazole prophylaxis reduces candidiasis , but its effect on mortality and the safety of fluconazole are unknown .


To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants .


This study was a randomized , blinded , placebo-controlled trial of fluconazole in premature infants .


Infants weighing less than @ g at birth ( N = @ ) from @ neonatal intensive care units ( NICUs ) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for @ days .


Surviving infants were evaluated at @ to @ months corrected age for neurodevelopmental outcomes .


The study was conducted between November @ and February @ .


Fluconazole ( @ mg/kg of body weight ) or placebo .


The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day @ ( @ week after completion of study drug ) .


Secondary and safety outcomes included invasive candidiasis , liver function , bacterial infection , length of stay , intracranial hemorrhage , periventricular leukomalacia , chronic lung disease , patent ductus arteriosus requiring surgery , retinopathy of prematurity requiring surgery , necrotizing enterocolitis , spontaneous intestinal perforation , and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than @ , blindness , deafness , or cerebral palsy at @ to @ months corrected age .


Among infants receiving fluconazole , the composite primary end point of death or invasive candidiasis was @ % ( @ % CI , @ % -@ % ) vs @ % in the placebo group ( @ % CI , @ % -@ % ; odds ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ; treatment difference , -@ % -LSB- @ % CI , -@ % to @ % -RSB- ) .


Invasive candidiasis occurred less frequently in the fluconazole group ( @ % -LSB- @ % CI , @ % -@ % -RSB- ) vs the placebo group ( @ % -LSB- @ % CI , @ % -@ % -RSB- ; P = @ ; treatment difference , -@ % -LSB- @ % CI , -@ % to -@ % -RSB- ) .


The cumulative incidences of other secondary outcomes were not statistically different between groups .


Neurodevelopmental impairment did not differ between the groups ( fluconazole , @ % -LSB- @ % CI , @ % -@ % -RSB- vs placebo , @ % -LSB- @ % CI , @ % -@ % -RSB- ; P = @ ; treatment difference , @ % -LSB- @ % CI , -@ % to @ % -RSB- ) .


Among infants with a birth weight of less than @ g , @ days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis .


These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants .


Bone metastases frequently cause skeletal events in patients with metastatic castration-resistant prostate cancer .


Radium-@ dichloride ( radium-@ ) selectively targets bone metastases with high-energy , short-range - particles .


We assessed the effect of radium-@ compared with placebo in patients with castration-resistant prostate cancer and bone metastases .


In this phase @ , double-blind , randomised ALSYMPCA trial , we enrolled patients who had symptomatic castration-resistant prostate cancer with two or more bone metastases and no known visceral metastases , who were receiving best standard of care , and had previously either received or were unsuitable for docetaxel .


Patients were stratified by previous docetaxel use , baseline total alkaline phosphatase level , and current bisphosphonate use , then randomly assigned ( @:@ ) to receive either six intravenous injections of radium-@ ( @ kBq/kg ) or matching placebo ; one injection was given every @ weeks .


Randomisation was done with an interactive voice response system , taking into account trial stratification factors .


Participants and investigators were masked to treatment assignment .


The primary endpoint was overall survival , which has been reported previously .


Here we report on time to first symptomatic skeletal event , defined as the use of external beam radiation to relieve bone pain , or occurrence of a new symptomatic pathological fracture ( vertebral or non-verterbal ) , or occurence of spinal cord compression , or tumour-related orthopeadic surgical intervention .


All events were required to be clinically apparent and were not assessed by periodic radiological review .


Statistical analyses of symptomatic skeletal events were based on the intention-to-treat population .


The study has been completed and is registered with ClinicalTrials.gov , number NCT@ .


Between June @ , @ , and Feb @ , @ , @ patients were enrolled , of whom @ ( @ % ) were randomly assigned to receive radium-@ and @ ( @ % ) placebo .


Symptomatic skeletal events occurred in @ ( @ % ) of @ patients in the radium-@ group and @ ( @ % ) of @ patients in the placebo group .


Time to first symptomatic skeletal event was longer with radium-@ than with placebo ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- = @ , @ % CI @-@ ; p = @ ) .


The risks of external beam radiation therapy for bone pain ( HR @ , @ % CI @-@ ) and spinal cord compression ( HR = @ , @ % CI @-@ ) were reduced with radium-@ compared with placebo .


Radium-@ treatment did not seem to significantly reduce the risk of symptomatic pathological bone fracture ( HR @ , @ % CI @-@ ) , or the need for tumour-related orthopaedic surgical intervention ( HR @ , @ % CI @-@ ) .


Radium-@ should be considered as a treatment option for patients with castration-resistant prostate cancer and symptomatic bone metastases .


Discontinuation of bisphosphonate therapy after @ to @ years is increasingly considered , but methods to monitor fracture risk after discontinuation have not been established .


To test methods of predicting fracture risk among women who have discontinued alendronate therapy after @ to @ years .


The prospective Fracture Intervention Trial Long-term Extension ( FLEX ) study randomized postmenopausal women aged @ to @ years previously treated with @ to @ years of alendronate therapy to @ more years of alendronate or placebo from @ through @ ; the present analysis includes only the placebo group .


Hip and spine dual-energy x-ray absorptiometry ( DXA ) were measured when placebo was begun ( FLEX baseline ) and after @ to @ years of follow-up .


Two biochemical markers of bone turnover , urinary type @ collagen cross-linked N-telopeptide ( NTX ) and serum bone-specific alkaline phosphatase ( BAP ) , were measured at FLEX baseline and after @ and @ years .


Symptomatic spine and nonspine fractures occurring after the follow-up measurement of DXA or bone turnover .


During @ years of placebo , @ of @ women ( @ % ) experienced @ or more symptomatic fractures ; @ had fractures after @ year .


One-year changes in hip DXA , NTX , and BAP were not related to subsequent fracture risk , but older age and lower hip DXA at time of discontinuation were significantly related to increased fracture risk ( lowest tertile of baseline femoral neck DXA vs other @ tertiles relative hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; total hip DXA relative hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Among postmenopausal women who discontinue alendronate therapy after @ to @ years , age and hip BMD at discontinuation predict clinical fractures during the subsequent @ years .


Follow-up measurements of DXA @ year after discontinuation and of BAP or NTX @ to @ years after discontinuation are not associated with fracture risk and can not be recommended .


Decreased ability of muscles to respond to anabolic stimuli is part of the underlying mechanism for muscle loss with aging .


Previous studies suggest that substantial amounts of essential amino acids ( EAA ) , whey protein and leucine are beneficial for stimulation of acute muscle protein synthesis in older adults .


However , these studies supplied only proteins , and no bolus studies have been done with dairy products or supplements that contained also fat and carbohydrates besides proteins .


The aim of this study was to evaluate whether a specifically designed nutritional supplement in older adults stimulates muscle protein synthesis acutely to a greater extent than a conventional dairy product .


Moreover , the combined effect with resistance exercise was studied by using a unilateral resistance exercise protocol .


Utilizing a randomized , controlled , double blind study design , healthy older adults received a single bolus of a high whey protein , leucine-enriched supplement ( EXP : @ g whey protein , @g total leucine , @ kcal ; n = @ ) or an iso-caloric milk protein control (


@g milk protein ; n = @ ) , immediately after unilateral resistance exercise .


Postprandial mixed muscle protein fractional synthesis rate ( FSR ) was measured over @h using a tracer infusion protocol with L - -LSB- ring-C -RSB- - phenylalanine and regular blood and muscle sampling .


FSR was significantly higher overall after EXP ( @ % / h ) vs CONTROL ( @ % / h ( EMMSE ) ) ( p = @ ) .


No interaction between treatment and exercise was observed ( p = @ ) .


Higher postprandial concentrations of EAA and leucine are possible mediating factors for the FSR response , while plasma insulin increase did not dictate the FSR response .


Moreover , when the protein intake from the supplements was expressed per kg leg lean mass ( LLM ) , a significant correlation was observed with resting postprandial FSR ( r = @ , P = @ ) .


Ingestion of a high whey protein , leucine-enriched supplement resulted in a larger overall postprandial muscle protein synthesis rate in healthy older subjects compared with a conventional dairy product .


This acute effect is promising for long-term effects on parameters of muscle mass , strength and function in sarcopenic older people , which requires further study .


To determine the effectiveness of a pedometer-based telephone lifestyle coaching intervention on weight and physical activity .


A randomized controlled trial was conducted with @ patients referred to cardiac rehabilitation in rural and urban Australia .


Participants were allocated to a healthy weight ( HW ) ( @ telephone coaching sessions on weight and physical activity ) or a physical activity ( PA ) intervention ( @ telephone coaching sessions on physical activity ) .


Weight and physical activity were assessed by self-report at baseline , short-term ( @-@ weeks ) , and medium-term ( @-@ months ) .


More than @ % of participants completed the trial .


Over the medium-term , participants in the HW group decreased their weight compared with participants in the PA group ( P = @ ) .


Participants in the HW group with a body mass index of @ kg/m had a mean weight loss of @ kg compared with participants in the PA-only group who lost a mean of @ kg ( P = @ ) .


Short-term , both groups increased their physical activity time , and the PA group maintained this increase at the medium-term .


Participants in the HW group achieved modest improvements in weight , and those in the PA group demonstrated increased physical activity .


Low-contact , telephone-based interventions are a feasible means of delivering lifestyle interventions for underserved rural communities , for those not attending cardiac rehabilitation , or as an adjunct to cardiac rehabilitation .


To compare the kinematics of lower limb joints between individuals with and without chronic ankle instability ( CAI ) during cross-turn and - cutting movements .


Cross-sectional study .


Motion analysis laboratory .


Twelve subjects with CAI and twelve healthy controls .


Hip flexion , adduction , and internal rotation , knee flexion , and ankle dorsiflexion and inversion angles were calculated in the @ms before initial ground contact and from initial ground contact to toe-off ( stance phase ) in a cross-turn movement during gait and a cross-cutting movement from a forward jump , and compared across the two groups .


In the cross-cutting movement , the CAI group exhibited greater hip and knee flexion than the control group during the stance phase , and more hip abduction during the period before initial contact and the stance phase .


In the cross-turn movement the joint kinematics were similar in the two groups .


CAI subjects exhibited an altered pattern of the proximal joint kinematics during a cross-cutting movement .


It is important for clinicians to assess the function of the hip and knee as well as the ankle , and to incorporate coordination training for the entire lower limb into rehabilitation after lateral ankle sprains .


It is thought that therapy should be functional , be highly repetitive , and promote afferent input to best stimulate hand motor recovery after stroke , yet patients struggle to access such therapy .


We developed the MusicGlove , an instrumented glove that requires the user to practice gripping-like movements and thumb-finger opposition to play a highly engaging , music-based , video game .


The purpose of this study was to @ ) compare the effect of training with MusicGlove to conventional hand therapy @ ) determine if MusicGlove training was more effective than a matched form of isometric hand movement training ; and @ ) determine if MusicGlove game scores predict clinical outcomes .


@ chronic stroke survivors with moderate hemiparesis were randomly assigned to receive MusicGlove , isometric , and conventional hand therapy in a within-subjects design .


Each subject participated in six one-hour treatment sessions three times per week for two weeks , for each training type , for a total of @ treatment sessions .


A blinded rater assessed hand impairment before and after each training type and at one-month follow-up including the Box and Blocks ( B & B ) test as the primary outcome measure .


Subjects also completed the Intrinsic Motivation Inventory ( IMI ) .


Subjects improved hand function related to grasping small objects more after MusicGlove compared to conventional training , as measured by the B & B score ( improvement of @ vs. -@ blocks ; P = @ ) and the @ Hole Peg test ( improvement of @ vs. -@ pegs/minute ; P = @ ) .


There was no significant difference between training types in the broader assessment batteries of hand function .


Subjects benefited less from isometric therapy than MusicGlove training , but the difference was not significant ( P > @ ) .


Subjects sustained improvements in hand function at a one month follow-up , and found the MusicGlove more motivating than the other two therapies , as measured by the IMI .


MusicGlove games scores correlated strongly with the B & B score .


These results support the hypothesis that hand therapy that is engaging , incorporates high numbers of repetitions of gripping and thumb-finger opposition movements , and promotes afferent input is a promising approach to improving an individual 's ability to manipulate small objects .


The MusicGlove provides a simple way to access such therapy .


Current US healthcare delivery systems do not adequately address healthcare demands .


Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes .


Home visitation is an effective method for changing health outcomes in some populations .


The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs .


We performed a prospective evaluation of @ households randomly assigned to one of two groups : visitation from a student team ( intervention group ) or limited intervention ( control group ) .


The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition .


All of the households were surveyed at baseline and after @ year of participation in the study .


After @ year in the program and after adjustment for confounders , intervention group households proved more likely ( P @ ) than control households to have undergone physical examinations , blood pressure monitoring , and cervical cytology screenings .


Cholesterol screenings and mammograms were borderline significant ( P = @ and P = @ , respectively ) .


This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures .


The study underscores the important role interprofessional student teams may play in improving the health of US communities , while students concurrently learn about primary prevention and primary care .


To observe the effect of detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn on carotid intima-media thickness ( IMT ) , plaque integral and plaque stability related serum indexes of patients with carotid atherosclerosis .


Sixty and four cases of carotid artery atherosclerosis patients were assigned randomly to @ groups : detoxifying and blood circulation activating treatment group ( treatment group , @ cases ) and control group ( @ cases ) .


Patients in treatment group were treated with capsules of extraction of polygonum cuspidatum and hawthorn , @ pill po , bid ( dosage of administration : polygonum cuspidatum extraction @ mg x kg ( -@ ) x d ( -@ ) , hawthorn extraction @ mg x kg ( -@ ) x d ( -@ ) ) ; patients in control group were treated with lovastatin @ mg po , qd ( dosage of administration : @ mg x kg ( -@ ) x d ( -@ ) ) .


The course of treatment was six months .


To observe changes of IMT , plaque integral , and detect the level of plaque stability related serum indexes such as Hs-CRP , MMP-@ and TIMP-@ .


After @ months of treatment , in control group one patient quit the clinical trial because of liver dysfunction and one patient was rejected because of having not followed the therapeutic regimen .


@ cases in treatment group and @ cases in control group were analyzed .


The results showed that IMT and plaque integral of treatment group decreased significantly after the treatment ( P < @ , P < @ ) , and there was no significant difference compared with control grope .


Serum Hs-CRP , MMP-@ and MMP-@ / TIMP-@ decreased after the treatment ( P < @ , P < @ ) , and the treatment group was superior to control group in decreasing serum Hs-CRP ( P < @ ) .


Detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn has good effect of anti-atherosclerosis and promoting plaque stability .


Its mechanism might be related with anti-inflammation and inhibiting degradation of extracellular matrix , and deserves further studies .


Hip fractures are a leading cause of mortality and disability worldwide , and the number of hip fractures is expected to rise to over @ million per year by @ .


The optimal approach for the surgical management of displaced femoral neck fractures remains unknown .


Current evidence suggests the use of arthroplasty ; however , there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty ( THA ) or hemiarthroplasty ( HA ) .


The HEALTH trial compares outcomes following THA versus HA in patients @years of age or older with displaced femoral neck fractures .


HEALTH is a multicentre , randomised controlled trial where @ patients , @years of age or older , with displaced femoral neck fractures from international sites are randomised to receive either THA or HA .


Exclusion criteria include associated major injuries of the lower extremity , hip infection ( s ) and a history of frank dementia .


The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes , patient quality of life , mortality and hip-related complications-both within @years of the initial surgery .


We are using minimisation to ensure balance between intervention groups for the following factors : age , prefracture living , prefracture functional status , American Society for Anesthesiologists ( ASA ) Class and centre number .


Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial .


Outcome analysis will be performed using a ( @ ) test ( or Fisher 's exact test ) and Cox proportional hazards modelling estimate .


All results will be presented with @ % CIs .


The HEALTH trial has received local and McMaster University Research Ethics Board ( REB ) approval ( REB # : @-@ ) .


Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences .


We will communicate trial results to all participating sites .


Participating sites will communicate results with patients who have indicated an interest in knowing the results .


To observe the difference in the analgesic effect on primary dysmenorrheal between acupuncture and sham acupuncture at Sanyinjiao ( SP @ ) during menstrual pain and evaluate the impact of psychological effect on acupuncture analgesia .


Sixty subjects were randomized into an acupuncture group and a sham acupuncture group , @ cases in each one .


The conventional acupuncture and sham acupuncture were applied to Sanyinjiao ( SP @ ) on bilateral sides when menstrual pain began to attack and needles were retained for @ min each time .


Three menstrual cycles were required .


The visual analogue scale ( VAS ) was adopted to determine the scores before and @ h , @ h , @ h , @ h and @ h after acupuncture during menstrual pain in each cycle separately .


In the acupuncture group , VAS score at each time point after acupuncture was reduced as compared with that at the previous one during menstrual pain in each menstrual cycle , indicating the significant difference ( all P < @ ) .