A prospective , randomized , single-blind , multicenter study evaluated @ patients with symptomatic peripheral arterial disease ( PAD ) after treatment with heparin-bonded covered stents ( VIABAHN ( ) Endoprosthesis ) or BMS .


Clinical outcomes and patency rates were assessed at @ , @ , @ , and @ months .


Mean lesion length was @ @ cm in the VIABAHN ( ) versus @ @ cm in the BMS group .


The @-month primary patency rates in the VIABAHN ( ) and BMS group were : intention-to-treat @ ( @ % CI @-@ @ ) versus @ % ( @ % CI @-@ @ ; log rank p = @ ) and TPP @ ( @ % CI @-@ @ ) versus @ % ( @ % CI @-@ @ ; log rank p = @ ) .


Freedom from target-lesion-revascularization ( TLR ) was @ ( @ % CI @-@ @ ) versus @ % ( @ % CI @-@ @ ) for VIABAHN ( ) versus BMS ( log rank p = @ ) .


For the TPP group in lesions @ cm , the @-month patency rates were @ ( @ % CI @-@ @ ) versus @ % ( @ % CI @-@ @ ; log rank p = @ ) for VIABAHN ( ) versus BMS , and freedom from TLR was @ ( @ % CI @-@ @ ) versus @ % ( @ % CI @-@ @ ; log rank p = @ ) .


The ankle brachial index was @ @ versus @ @ ( p = @ ) at @-month in the VIABAHN ( ) versus the BMS group , respectively .


At @-month , this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS , however , without a significant impact on clinical outcomes and TLR rate ( Reg .


Nr .


ISRCTN@ ) .


The treat-to-target ( T@T ) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity , frequent follow-up visits for patients with moderate to high disease activity , and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores .


The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T@T approach in US rheumatology practices .


It is designed to identify patient and provider barriers to implementing T@T management .


This initial paper focuses on the novel study design and methods created to provide these insights .


This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T@T or usual care ( UC ) for qualified patients who meet the @ revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity .


Specific medication choices are left to the investigator and patient , rather than being specified in the protocol .


Enrollment is expected to be completed by the end of @ , with @ practices randomized and enrolling a minimum of @ patients .


During the @-month follow-up , visits are mandated as frequently as monthly in patients with active disease in the T@T group and every @ months for the UC group .


Safety data are collected at each visit .


The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T@T and UC groups and assessment of the feasibility of implementing T@T in rheumatology practices , specifically assessment of the rates of treatment acceleration , frequency of visits , time to next visit conditional on disease activity , and probability of acceleration conditional on disease activity in the @ groups .


This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T@T treatment approach in clinical practice in the United States .


We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage ( ICH ) to better inform clinicians and researchers in their efforts to improve outcomes for patients .


We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials ( INTERACT@ and @ , respectively ) .


The study group was divided into a derivation cohort ( INTERACT@ , n = @ ) and a validation cohort ( INTERACT@ , n = @ ) .


Multivariable logistic regression was used to identify factors associated with clinically significant ( @ mL ) increase in hematoma volume at @ hours after symptom onset .


A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model .


A @-point BRAIN score was derived from INTERACT@ ( C-statistic , @ ) based on baseline ICH volume ( mL per score , @ = @ , @-@ = @ , > @ = @ ) , recurrent ICH ( yes = @ ) , anticoagulation with warfarin at symptom onset ( yes = @ ) , intraventricular extension ( yes = @ ) , and number of hours to baseline computed tomography from symptom onset ( @ = @ , @-@ = @ , @-@ = @ , @-@ = @ , @-@ = @ , > @ = @ ) predicted the probability of ICH growth ( ranging from @ % for @ point to @ % for @ points ) with good discrimination ( C-statistic , @ ) and calibration ( Hosmer-Lemeshow P = @ ) in INTERACT@ .


The simple BRAIN score predicts the probability of hematoma growth in ICH .


This could be used to improve risk stratification for research and clinical practice .


The aim of this trial was to compare functional capacity , pulmonary shunt fraction and clinical outcomes between patients undergoing pleurotomy with a pleural drain inserted in the sub-xyphoid position and patients with a pleural drain placed in the intercostal position after off-pump coronary artery bypass surgery .


Patients were randomized into two groups according to the pleural drain site : Group II ( n = @ intercostal pleural drain ) ; and Group SI ( n = @ sub-xyphoid pleural drain ) .


Functional capacity was assessed by the distance covered on the @-min walking test performed preoperatively and on postoperative day ( POD ) @ ; in addition , pulmonary function test was determined preoperatively and on POD @ and @ .


Pulmonary shunt fraction was evaluated preoperatively and on POD @ , and clinical outcomes were recorded throughout the study .


Group SI had better preservation of lung volumes and capacities in POD compared with Group II ( P < @ ) .


Pulmonary shunt fraction increased in both groups postoperatively ; however , Group SI showed a smaller pulmonary shunt fraction ( @ @ vs @ @ % ; P = @ ) .


Functional capacity was significantly reduced in both groups on POD @ ; however , Group SI showed better preservation of functional capacity ( P = @ ) .


Group SI had better postoperative clinical results , with lower incidence of atelectasis and pleural effusion ( P < @ ) , lower pain scores ( P < @ ) , and shorter orotracheal intubation and hospitalization lengths ( P < @ ) .


Sub-xyphoid pleural drain determined better functional capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery .


Acute renal failure ( ARF ) requiring renal replacement therapy ( RRT ) occurs frequently in ICU patients and significantly affects mortality rates .


Previously , few large clinical trials investigated the impact of RRT modalities on patient outcomes .


Here we investigated the effect of two major RRT strategies ( intermittent hemodialysis ( IHD ) and continuous veno-venous hemofiltration ( CVVH ) ) on mortality and renal-related outcome measures .


This single-center prospective randomized controlled trial ( `` CONVINT '' ) included @ critically ill patients ( @ male ; mean age , @ years ; Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , @ ) with dialysis-dependent ARF treated in the ICUs of a tertiary care academic center .


Patients were randomized to receive either daily IHD or CVVH .


The primary outcome measure was survival at @ days after the end of RRT .


Secondary outcome measures included @-day - , intensive care unit - , and intrahospital mortality , as well as course of disease severity/biomarkers and need for organ-support therapy .


At baseline , no differences in disease severity , distributions of age and gender , or suspected reasons for acute renal failure were observed .


Survival rates at @ days after RRT were @ % ( IHD ) versus @ % ( CVVH ) ( odds ratio ( OR ) , @ ; @ % confidence interval ( CI ) , @ to @ ; P = @ ) .


@-day - , @-day , and all-cause intrahospital mortality rates were not different between the two groups ( all P > @ ) .


No differences were observed in days on RRT , vasopressor days , days on ventilator , or ICU - / intrahospital length of stay .


In a monocentric RCT , we observed no statistically significant differences between the investigated treatment modalities regarding mortality , renal-related outcome measures , or survival at @ days after RRT .


Our findings add to mounting data demonstrating that intermittent and continuous RRTs may be considered equivalent approaches for critically ill patients with dialysis-dependent acute renal failure .


Routine use of pulse oximetry has been associated with changes in bronchiolitis management and may have lowered the hospitalization threshold for patients with bronchiolitis .


To examine if infants with bronchiolitis whose displayed oximetry measurements have been artificially elevated @ percentage points above true values experience hospitalization rates at least @ % lower compared with infants with true values displayed .


Randomized , double-blind , parallel-group trial conducted from @ to @ in a tertiary-care pediatric emergency department in Toronto , Ontario , Canada .


Participants were @ otherwise healthy infants aged @ weeks to @ months with mild to moderate bronchiolitis and true oxygen saturations of @ % or higher .


Pulse oximetry measurements with true saturation values displayed or with altered saturation values displayed that have been increased @ percentage points above true values .


The primary outcome was hospitalization within @ hours , defined as inpatient admission within this interval or active hospital care for greater than @ hours .


Secondary outcomes included the use of supplemental oxygen in the emergency department , level of physician agreement with discharge from the emergency department , length of emergency department stay , and unscheduled visits for bronchiolitis within @ hours .


Forty-four of @ patients ( @ % ) in the true oximetry group and @ of @ ( @ % ) in the altered oximetry group were hospitalized within @ hours ( difference , @ % -LSB- @ % CI for the difference , @ % to @ % -RSB- ; P = @ ) .


Using the emergency department physician as a random effect , the primary treatment effect remained significant ( adjusted odds ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


None of the secondary outcomes were significantly different between the groups .


There were @ of @ ( @ % ) subsequent unscheduled medical visits for bronchiolitis in the true oximetry group and @ of @ ( @ % ) in the altered oximetry group ( difference , @ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) .


Among infants presenting to an emergency department with mild to moderate bronchiolitis , those with an artificially elevated pulse oximetry reading were less likely to be hospitalized within @ hours or to receive active hospital care for more than @ hours than those with unaltered oximetry readings .


This suggests that oxygen saturation should not be the only factor in the decision to admit , and its use may need to be reevaluated .


Voluntary medical male circumcision ( VMMC ) is a priority HIV preventive intervention .


To facilitate VMMC scale-up , the World Health Organization is seeking circumcision techniques that are faster , easier , and safer than open surgical methods .


To compare open surgical circumcision with suturing v. the Unicirc disposable instrument plus tissue adhesive .


We conducted a non-blinded randomised controlled trial at an outpatient primary healthcare clinic in Cape Town , South Africa , with @:@ allocation ratio of @ male volunteers who were at least @ years of age .


Our primary outcome was intraoperative time and secondary outcomes were ease of performance , post-operative pain , adverse events , time to healing , patient satisfaction and cosmetic result .


The intraoperative time was less with the Unicirc/adhesive technique ( median @ v. @ min , respectively ; p < @ ) .


The intraoperative suturing rate was @ % using the Unicirc device .


Other adverse events and wound healing outcomes were similar in both groups , but the cosmetic result was superior in the Unicirc group .


Doctors found the Unicirc procedure easier to perform and preferred it to the open surgical technique .


This study has important implications for the scale-up of VMMC services .


Excising the foreskin with the Unicirc instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker , easier to learn , and is potentially safer than open surgical VMMC .


Further studies should be conducted with the optimised device .


This new instrument has the potential to facilitate more rapid scale-up and save costs .


To assess the antidepressant efficacy of S-adenosyl methionine ( SAMe ) , a naturally occurring methyl donor , versus the selective serotonin reuptake inhibitor ( SSRI ) escitalopram and a placebo control ; and to determine whether serum histamine or carnitine levels modified treatment response .


We examined a subsample ( n = @ ) from one site of a two-site study of adults with diagnosed Major Depressive Disorder ( MDD ) , recruited from @/@/@ to @/@/@ , who consented to the additional blood draw for serum histamine and carnitine levels .


After washout , eligible subjects were randomized to SAMe ( @-@mg / daily ) , escitalopram ( @-@mg / daily ) , or matching placebo for @ weeks of double-blind treatment ( titration at week @ in non-response ) .


On the primary outcome of the Hamilton Depression Rating Scale ( HAMD-@ ) , a significant difference in improvement was observed between groups from baseline to week @ ( p = @ ) .


The effect size from baseline to endpoint was moderate to large for SAMe versus placebo ( d = @ ) .


SAMe was superior to placebo from week @ , and to escitalopram during weeks @ , @ , and @ .


No significant effect was found between escitalopram and placebo or SAMe .


Response rates ( HAMD-@ % reduction ) at endpoint were @ % , @ % , and @ % for SAMe , escitalopram , and placebo , respectively ; while remission rates ( HAM-D@ ) were @ % for SAMe ( p = @ ) , @ % for escitalopram ( p = @ ) , and @ % for placebo .


No correlation between baseline histamine level and reduction of HAMD-@ score was found for either the SAMe or escitalopram groups .


Baseline carnitine levels were also not found to moderate response to either treatment .


While SAMe appears to be an effective antidepressant agent , the overall findings from the parent study ( which showed no significant difference between groups due to site differences ) must be taken into consideration .


These preliminary results provide encouraging evidence for the use of SAMe in the treatment of MDD .


Histamine and carnitine serum level may not necessarily moderate response to SAMe .


To assess the longterm safety and effectiveness of tocilizumab ( TCZ ) in systemic-onset juvenile idiopathic arthritis ( sJIA ) .


The longterm extension phase of @ pivotal studies ( phase II with @ patients and phase III with @ patients ) in patients with active sJIA was analyzed .


Patients received open-label TCZ ( @ mg/kg , every @ weeks ) without concomitant use of disease-modifying antirheumatic drugs .


In total , @ patients were enrolled .


All patients received corticosteroid at baseline .


Median duration of exposure to TCZ was @ years .


Nine patients withdrew from the study -LSB- @ because of adverse events ( AE ) , @ because of the development of anti-TCZ antibodies , and @ because of inadequate response -RSB- .


Rates of AE and serious AE were @ / @ patient-years ( PY ) and @ / @ PY , respectively .


The most common serious AE were infections ( @ / @ PY ) .


No cases of malignancy or death were reported .


Two serious infusion reactions were reported in patients testing negative for anti-TCZ antibodies .


One definite macrophage activation syndrome ( MAS ) case and @ potential MAS case were identified .


American College of Rheumatology ( ACR ) response rates attained early in the TCZ treatment period were maintained throughout the study : at Week @ , JIA ACR @ , @ , @ , @ , and @ response rates were @ % , @ % , @ % , @ % , and @ % , respectively .


In total , @ of @ patients ( @ % ) completely discontinued corticosteroids without flare .


TCZ has demonstrated durability of effectiveness in the longterm treatment of children with sJIA and has shown good tolerability and a low discontinuation rate associated with AE , development of anti-TCZ antibodies , or inadequate response .


( ClinicalTrials.gov NCT@ and NCT@ ) .


( First Release March @ @ ; J Rheumatol @ ; @:@ -@ ; doi :@ / jrheum @ ) .


The purpose of this study was to determine the effects of a multinutritional supplement including amino acids , - hydroxy -- methylbutyrate ( HMB ) , and carbohydrates on cytokine responses to resistance exercise and training .


Seventeen healthy , college-aged men were randomly assigned to a Muscle Armor ( MA ; Abbott Nutrition , Columbus , OH ) or placebo supplement group and @ weeks of resistance training .


An acute resistance exercise protocol was administered at @ , @ , and @ weeks of training .


Venous blood samples at pre - , immediately post - , and @-minutes postexercise were analyzed via bead multiplex immunoassay for @ cytokines .


After @ weeks of training , the MA group exhibited decreased interferon-gamma ( IFN - ) and interleukin ( IL ) -@ .


IL-@ differed by group at various times .


Granulocyte colony-stimulating factor ( G-CSF ) , granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , IL-@ , IL-@ , IL-@ , IL-@p@ , IL-@ , IL-@ , monocyte chemoattractant protein-@ ( MCP-@ ) , and macrophage inflammatory protein-@ beta ( MIP-@ ) changed over the @-week training period but did not differ by group .


Twelve weeks of resistance training alters the cytokine response to acute resistance exercise , and supplementation with HMB and amino acids appears to further augment this result .


To determine the short-term clinical effects of levosimendan in acute myocardial infarction ( AMI ) patients with myocardial stunning after emergency percutaneous coronary intervention ( PCI ) .


The study population consisted of @ patients with AMI who received emergency PCI and satisfied the inclusion criteria .


Levosimendan was given as a continuous infusion of @ g/kg/min for @ h , and the remaining @ patients received placebo treatment .


The patients were observed with invasive haemodynamic monitoring and were evaluated biochemically and echocardiographically before and after the drug infusion .


Following treatment , biochemical indices ( not including creatine kinase and its MB fraction ) were significantly lower in the levosimendan group than in the placebo group .


Meanwhile , left-ventricular ( LV ) end-systolic volume , mean pulmonary arterial pressure , pulmonary capillary wedge pressure and systemic vascular resistance were significantly reduced in the levosimendan group , whereas the early-to-late diastolic velocities ratio , LV ejection fraction , cardiac index and cardiac power index were increased .


Troponin I levels were reduced and fewer stunned and infarction segments were observed in the patients treated with levosimendan .


Levosimendan can significantly improve the myocardium function of patients with myocardial stunning after PCI .


Treatment with rosiglitazone , a peroxisome proliferator-activated receptor - agonist , in type @ diabetic mellitus ( T@DM ) patients is under scrutiny because it affects adversely cardiovascular outcomes .


In T@DM patients , with existing coronary heart disease , short-term treatment with rosiglitazone increases myocardial glucose uptake ( MGU ) .


Serum metabolic and lipoprotein subclass changes , which may be associated with this rosiglitazone-induced improvement , are unknown .


Patients with both T@DM and coronary heart disease were separated into placebo ( n = @ ) and treatment ( rosiglitazone @-@ mg ; n = @ ) groups .


After @ weeks of treatment , serum NMR metabolomics was used to measure circulating low-molecular-weight metabolites and lipoprotein subclasses and lipids that are associated with T@DM before and after the treatment .


Significant metabolic measure changes after rosiglitazone treatment were correlated to MGU values assessed with -LSB- ( @ ) F -RSB- fluorodeoxyglucose positron emission tomography .


Compared to placebo , the treatment significantly increased circulating glutamine and decreased lactate concentrations .


Circulating lactate concentrations showed a significant inverse association with MGU after rosiglitazone treatment .


In T@DM patients with existing coronary heart disease , short-term rosiglitazone treatment caused minor improvements in metabolism : serum lactate and glutamine concentrations changed , reflecting improvements in insulin sensitivity , and circulating lactate concentrations inversely correlated to increases in myocardial glucose uptake .


This study aims at ascertaining the capacity of @ groups of young athletes to be faithful to the initial oral prevention project , with the difference that the study group received motivational reminders by either researchers and technical staff members of the team during the observation period , while the control group did not receive any motivational reminders .


This observational study was based on two groups selected from a wide group of @ adolescent basketball players who accepted to use a custom-made mouth guard during their sport sessions .


None of the selected athletes ( @ adolescents aged between @ and @ years ) had ever worn a mouth guard during their sports activity .


A customised mouth guard was supplied , and subjetcs were requested to wear it for @ months during training sessions and competitions .


The study group was composed of @ athletes , @ males and @ females , who received a constant motivational reinforcement to the use of the mouth guard by their coach and during checkups .


Similarly , the control group was composed of @ athletes ( @ males and @ females ) who did not receive any motivational reinforcement .


Twelve months after the beginning of the study , @ subjects belonging to the control group were not using the mouth guard , while only @ subjects of the study group were not using it .


It was also noticed , six months after the beginning of the observation period , a rapid decline in the participants ' interest in the use of the mouth guard .


No traumatic event was registered among those adolescents who had used the mouth guard for the whole period of the study .


Female athletes showed greater compliance to this prevention project .


It is important that all technical staff members , and particularly the leading coach , encourage the regular use of oral protection devices for prevention among teenagers practicing sports .


Physical activity is important for a healthy lifestyle .


Although physical activity can delay complications and decrease the burden of the disease , the level of activity of patients with chronic obstructive pulmonary disease ( COPD ) or type @ Diabetes Mellitus ( DM@ ) is often far from optimal .


To stimulate physical activity , a monitoring and feedback tool , consisting of an accelerometer linked to a smart phone and webserver ( It 's LiFe !


tool ) , and a counselling protocol for practice nurses in primary care was developed ( the Self-management Support Program ) .


The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool .


This three-armed cluster randomised controlled trial with @ participants with COPD and @ participants with DM@ ( aged @-@ ) , compares the counselling protocol with and without the use of the tool ( group @ and @ ) with usual care ( group @ ) .


Recruitment takes place at GP practices in the southern regions of the Netherlands .


Randomisation takes place at the practice level .


The intended sample ( three arms of @ practices ) powers the study to detect a @-minute difference of moderate and intense physical activity per day between groups @ and @ .


Participants in the intervention groups have to visit the practice nurse @-@ times for physical activity counselling , in a @-@-month period .


Specific activity goals tailored to the individual patient 's preferences and needs will be set .


In addition , participants in group @ will be instructed to use the tool in daily life .


The primary outcome , physical activity , will be measured in all groups with a physical activity monitor ( PAM ) .


Secondary outcomes are quality of life , general - and exercise - self-efficacy , and health status .


Follow-up will take place after @ and @months .


Separately , a process evaluation will be conducted to explore reasons for trial non-participation , and the intervention 's acceptability for participating patients and nurses .


Results of this study will give insight into the effects of the It 's LiFe !


monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM@ on physical activity .


Pre-exposure prophylaxis ( PrEP ) may be an important safer conception strategy for HIV-@-uninfected women with HIV-@-infected partners .


Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy .


We evaluated predictors of pregnancy and adherence to study medication among HIV-@-uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-@-serodiscordant couples .


Participants were counseled on HIV-@ risk reduction , contraception , and adherence and tested for pregnancy at monthly study visits .


Pill counts of dispensed drug were performed and , at a subset of visits , plasma was collected to measure active drug concentration .


Among @ women , pregnancy incidence was @ per @ person-years .


Younger age , not using contraception , having an additional sexual partner , and reporting unprotected sex were associated with increased likelihood of pregnancy .


Monthly clinic pill counts estimated that women experiencing pregnancy took @ % of prescribed doses overall , with at least @ % pill adherence for @ % of study months , and no difference in adherence in the periconception period compared with previous periods ( P = @ ) .


Tenofovir was detected in plasma at @ % of visits where pregnancy was discovered .


By multiple measures , adherence was similar for women experiencing and not experiencing pregnancy ( P @ ) .


In this clinical trial of PrEP , pregnancy incidence was @ % per year despite excellent access to effective contraception .


Women experiencing pregnancy had high medication adherence , suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-@-uninfected women with HIV-@-serodiscordant partners .


Patients with acute coronary syndrome and concomitant atrial fibrillation may require antithrombotic triple therapy but clinical evidence of safety and efficacy is poor .


We have therefore studied the combination of different antithrombotic medicines for coagulation activation in an in vivo model in the skin microvasculature .


Platelet activation ( - thromboglobulin -LSB- - TG -RSB- ) and thrombin generation ( prothrombin fragment @ + @ -LSB- F@ +@ -RSB- , thrombin-antithrombin complex -LSB- TAT -RSB- ) were studied in an open-label , randomized , parallel group trial in @ healthy male subjects ( n = @ per group ) who received ticagrelor and acetylsalicylic acid ( ASA ) in combination with dabigatran ( @ mg bid ) , rivaroxaban ( @ mg od ) or phenprocoumon ( INR @-@ @ ) .


Coagulation biomarkers in shed blood were assessed at @ h after monotherapy with the medicines under study , at @ h after triple therapy dosing and at steady state trough conditions .


Single doses of ticagrelor , dabigatran or rivaroxaban caused comparable decreases in shed blood - TG and were more pronounced than phenprocoumon at an INR of @-@ @ .


In contrast , thrombin generation was more affected by rivaroxaban and phenprocoumon than by dabigatran .


During triple therapy a similarly sustained inhibition of platelet activation and thrombin generation with a maximum decrease of - TG , F@ +@ and TAT at @ h post-dosing was noted , which remained below pre-dose levels at trough steady state .


A triple therapy at steady state with ticagrelor plus ASA in combination with dabigatran or rivaroxaban is as effective as a combination with phenprocoumon for platelet activation and thrombin generation in vivo .


Apremilast works intracellularly to regulate inflammatory mediators .


ESTEEM @ evaluated efficacy/safety of apremilast at @ mg twice a day for moderate to severe plaque psoriasis .


This phase III , multicenter , double-blind , placebo-controlled study randomized adults ( @:@ ) to apremilast or placebo .


At week @ , the placebo group switched to apremilast through week @ , followed by a randomized treatment withdrawal phase to week @ .


Binary end points were analyzed using ( @ ) test ; continuous end points used analysis of covariance .


In all , @ patients were randomized ( n = @ , placebo ; n = @ , apremilast ) .


At week @ , significantly more patients taking apremilast achieved @ % or greater reduction from baseline Psoriasis Area and Severity Index score ( PASI-@ ) ( @ % ) versus placebo ( @ % , P < @ ; primary end point ) .


Most ( @ % ) patients rerandomized to apremilast at week @ achieved PASI-@ at week @ versus @ % rerandomized to placebo .


Of patients rerandomized to apremilast at week @ , mean percentage change from baseline PASI score was -@ % to -@ % ( weeks @-@ ) .


During the placebo-controlled period , @ % and @ % of patients randomized toplacebo and apremilast , respectively , had @ or more adverse events .


Most adverse events were mild/moderate in severity .


No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period .


Data were limited to @ weeks and may not generalize to nonplaque psoriasis .


Apremilast was effective in moderate to severe plaque psoriasis .


To clarify the potential value of second-look laparoscopy ( SLL ) in improving fertility outcomes after laparoscopic salpingostomy for tubal pregnancy .


Randomized controlled trial .


West China Second University Hospital , Sichuan University .


@ women with future birth demand who underwent laparoscopic salpingostomy for tubal pregnancy .


SLL was performed in the SLL group at @ months after the primary surgery .


In both the SLL and control groups , the subjects were assigned to a slight adhesion ( SLA ) or severe adhesion ( SEA ) subgroup .


At @-year follow-up , the fertility outcomes were compared between the SLL and control groups and also between the SLA and SEA subgroups .


The intrauterine pregnancy rate was higher in the SLL group compared with the control group ( @ % vs @ % ; p = @ ) , and the incidence of recurrent ectopic pregnancy was lower in the SLL group than in the control group ( @ % vs @ % ; p = @ ) .


In the control group , the cumulative pregnancy rate was higher in the SLA subgroup compared with the SEA subgroup ( p = @ ) , but in the SLL group , the cumulative pregnancy rate did not differ between the @ subgroups ( p = @ ) .


The cumulative pregnancy rate was higher in the SEA subgroup of the SLL group compared with the SEA subgroup of the control group ( p = @ ) , but did not differ between the SLA subgroup of the SLL group and the SLA subgroup of the control group ( p = @ ) .


SLL may improve subsequent fertility outcome after laparoscopic salpingostomy for tubal pregnancy , and may be especially recommended for women with severe and extensive pelvic adhesions .


Optimum management strategies for patients with advanced non-small-cell lung cancer ( NSCLC ) with acquired resistance to EGFR tyrosine-kinase inhibitors are undefined .


We aimed to assess the efficacy and safety of continuing gefitinib combined with chemotherapy versus chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC with acquired resistance to first-line gefitinib .


The randomised , phase @ , multicentre IMPRESS study was done in @ centres in @ countries in Europe and the Asia-Pacific region .


Eligible patients were aged at least @ years with histologically confirmed , chemotherapy-naive , stage IIIB-IV EGFR-mutation-positive advanced NSCLC with previous disease control with first-line gefitinib and recent disease progression ( Response Evaluation Criteria in Solid Tumors version @ ) .


Participants were randomly assigned ( @:@ ) by central block randomisation to oral gefitinib @ mg or placebo once daily in tablet form ; randomisation did not include stratification factors .


All patients also received the platinum-based doublet chemotherapy cisplatin @ mg/m ( @ ) plus pemetrexed @ mg/m ( @ ) on the first day of each cycle .


After completion of a maximum of six chemotherapy cycles , patients continued their randomly assigned treatment until disease progression or another discontinuation criterion was met .


All study investigators and participants were masked to treatment allocation .


The primary endpoint was progression-free survival in the intention-to-treat population .


Safety was assessed in patients who received at least one dose of study treatment .


The study has completed enrolment , but patients are still in follow-up for overall survival .


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


Between March @ , @ , and Dec @ , @ , @ patients were randomly assigned : @ to the gefitinib group and @ to the placebo group .


At the time of data cutoff ( May @ , @ ) , @ ( @ % ) patients had disease progression in the gefitinib group compared with @ ( @ % ) in the placebo group ( hazard ratio @ , @ % CI @-@ ; p = @ ; median progression-free survival @ months in both groups -LSB- @ % CI @-@ in the gefitinib group and @-@ in the placebo group -RSB- ) .


The most common adverse events of any grade were nausea ( @ -LSB- @ % -RSB- of @ patients in the gefitinib group and @ -LSB- @ % -RSB- of @ patients in the placebo group ) and decreased appetite ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- ) .


The most common adverse events of grade @ or worse were anaemia ( @ -LSB- @ % -RSB- of @ patients in the gefitinib group and five -LSB- @ % -RSB- of @ patients in the placebo group ) and neutropenia ( nine -LSB- @ % -RSB- and seven -LSB- @ % -RSB- ) .


@ ( @ % ) of @ patients in the gefitinib group and @ ( @ % ) of @ patients in the placebo group reported serious adverse events .


Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment .


Platinum-based doublet chemotherapy remains the standard of care in this setting .


During endoscopic retrograde cholangiopancreatography ( ERCP ) , a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions .


The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel , single , stiff-shaft , flexible-tip guidewire .


Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a @-cm long , angled-tip hydrophilic wire in combination with a nitinol wire as required ( standard group ) , or a novel , @-cm guidewire featuring a hyperflexible , hydrophilic tip with a stiff shaft ( novel group ) .


At unsuccessful negotiation of the stricture , patients in the standard group were switched to the novel guidewire and vice versa ( `` crossover '' ) .


Successful cannulation ( primary success : as assigned ; final success : after `` crossover '' ) , procedure time , and total number of wires needed per procedure were compared .


A total of @ patients were randomized and @ were included in the study ( @ in the standard group and @ in the novel group ) .


The primary success rate was significantly higher in the novel group ( @/@ , @ % ) compared with the standard group ( @/@ , @ % ; P = @ ) , and final success was similar .


Mean time ( median , interquartile range ) to stricture cannulation was @ minutes ( @ , @-@ @ ) in the standard group and @ minutes ( @ , @-@ @ ) in the novel group ( P < @ ) .


The mean total procedure time was @ minutes ( @ , @-@ @ ) vs. @ minutes ( @ , @-@ @ ) , respectively ( P = @ ) .


There were no complications observed with either of the guidewires .


A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier : NCT @ .


Questions enhance learning in Web-based courses , but preliminary evidence suggests that too many questions may interfere with learning .


The authors sought to determine how varying the number of self-assessment questions affects knowledge outcomes in a Web-based course .


The authors conducted a randomized crossover trial in one internal medicine and one family medicine residency program between January @ and July @ .


Eight Web-based modules on ambulatory medicine topics were developed , with varying numbers of self-assessment questions ( @ , @ , @ , @ , or @ ) .


Participants completed modules in four different formats each year , with sequence randomly assigned .


Participants completed a pretest for half their modules .


Outcomes included knowledge , completion time , and module ratings .


One hundred eighty residents provided data .


The mean ( standard error ) percent correct knowledge score was @ ( @ ) for pretests and @ ( @ ) for posttests .


In repeated-measures analysis pooling all data , mean posttest knowledge scores were highest for the @ - and @-question formats ( @ -LSB- @ -RSB- and @ -LSB- @ -RSB- , respectively ) and lower for @ - , @ - , and @-question formats ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- , and @ -LSB- @ -RSB- , respectively ) ; P = @ for differences across all modules .


Modules with more questions generally took longer to complete and were rated higher , although differences were small .


Residents most often identified @ questions as ideal .


Posttest knowledge scores were higher for modules that included a pretest ( @ -LSB- @ -RSB- versus @ -LSB- @ -RSB- ; P = @ ) .


Increasing the number of self-assessment questions improves learning until a plateau beyond which additional questions do not add value .


Low compliance with training programs is likely to be one of the major reasons for inconsistency of the data regarding the effectiveness of current anterior cruciate ligament ( ACL ) injury prevention programs .


Training methods that reduce training time and cost could favorably influence the effectiveness of ACL injury prevention programs .


A newly designed knee extension constraint training device may serve this purpose .


( @ ) Knee extension constraint training for @ weeks would significantly increase the knee flexion angle at the time of peak impact posterior ground-reaction force and decrease peak impact ground-reaction forces during landing of a stop-jump task and a side-cutting task , and ( @ ) the training effects would be retained @ weeks after completion of the training program .


Controlled laboratory study .


Twenty-four recreational athletes were randomly assigned to group A or B. Participants in group A played sports without wearing a knee extension constraint device for @ weeks and then played sports while wearing the device for @ weeks , while participants in group B underwent a reversed protocol .


Both groups were tested at the beginning of week @ and at the ends of weeks @ and @ without wearing the device .


Knee joint angles were obtained from @-dimensional videographic data , while ground-reaction forces were measured simultaneously using force plates .


Analyses of variance were performed to determine the training effects and the retention of training effects .


Participants in group A significantly increased knee flexion angles and decreased ground-reaction forces at the end of week @ ( P @ ) .


Participants in group B significantly increased knee flexion angles and decreased ground-reaction forces at the ends of weeks @ and @ ( P @ ) .


However , participants in group B decreased knee flexion angles and increased ground-reaction forces at the end of week @ in comparison with the end of week @ ( P @ ) .


Knee extension constraint training for @ weeks significantly altered lower extremity movement patterns and transferred these changes in lower extremity movement patterns to stop-jump and side-cutting tasks in which ACL injuries frequently occur .


Training effects were retained @ weeks after the training was completed but were diminished in magnitude .


A knee extension constraint device may be a useful training tool in future ACL injury prevention programs to alter movement patterns without extra training time .


The risk of cardiovascular disease is tremendously high in dialysis patients .


Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients .


We examined the influence of two common vitamin D analogs , alfacalcidol and paricalcitol , on important cardiovascular biomarkers in hemodialysis patients .


Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined .


In @ chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol , we examined the changes in osteoprotegerin , fetuin-A , NT-proBNP , hs-Crp , IL-@ and TNF - , during @weeks of treatment .


NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups .


Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group ( difference @ mol/l ( @ % C.I. ; range @-@ @ ) ) during the first treatment period .


No difference was found between the groups during the second treatment period , and IL-@ , TNF - and hs-Crp were unchanged in both treatment groups .


Paricalcitol and alfacalcidol modulate regulators of vascular calcification .


Alfacalcidol may increase the level of the calcification inhibitor fetuin-A .


We did not find any anti-inflammatory effect or difference in changes of NT-proBNP .


Men with advanced prostate cancer ( APC ) undergoing androgen deprivation therapy ( ADT ) often experience distressing sexual side effects .


Sexual bother is an important component of adjustment .


Factors associated with increased bother are not well understood .


This study sought to describe sexual dysfunction and bother in APC patients undergoing ADT , identify socio-demographic and health/disease-related characteristics related to sexual bother , and evaluate associations between sexual bother and psychosocial well-being and quality of life ( QOL ) .


Baseline data of a larger psychosocial intervention study was used .


Pearson 's correlation and independent samples t-test tested bivariate relations .


Multivariate regression analysis evaluated relations between sexual bother and psychosocial and QOL outcomes .


The Expanded Prostate Cancer Index Composite sexual function and bother subscales , Center for Epidemiologic Studies Depression Scale , Functional Assessment of Cancer Therapy -- General , and Dyadic Adjustment Scale were the main outcome measures .


Participants ( N = @ ) were @ years old ( standard deviation -LSB- SD -RSB- = @ ) and reported @ months ( SD = @ ) of ADT .


Sexual dysfunction ( mean = @ ; SD = @ ) was highly prevalent .


Greater sexual bother ( lower scores ) was related to younger age ( = @ , P = @ ) and fewer months of ADT ( = @ , P = @ ) .


Controlling for age , months of ADT , current and precancer sexual function , sexual bother correlated with more depressive symptoms ( = -@ , P = @ ) and lower QOL ( = @ , P = @ ) .


Contrary to hypotheses , greater sexual bother was related to greater dyadic satisfaction ( = -@ , P = @ ) and cohesion ( = -@ , P = @ ) .


The majority of APC patients undergoing ADT will experience sexual dysfunction , but there is variability in their degree of sexual bother .


Psychosocial aspects of sexual functioning should be considered when evaluating men 's adjustment to ADT effects .


Assessment of sexual bother may help identify men at risk for more general distress and lowered QOL .


Psychosocial interventions targeting sexual bother may complement medical treatments for sexual dysfunction and be clinically relevant , particularly for younger men and those first starting ADT .


To investigate the pharmacokinetic/pharmacodynamic ( PK/PD ) interaction between irbesartan ( IRB ) and hydrochlorothiazide ( HCT ) in normotensive subjects .


A three-way crossover study was used .


Serial drug concentrations and drug effects , including systolic and diastolic blood pressure and heart rate were monitored after administration of irbesartan and hydrochlorothiazide alone and in combination .


The data were fitted to a PK/PD model and the parameters for irbesartan and hydrochlorothiazide when administered alone and in combination were compared .


The plasma profiles for irbesartan and hydrochlorothiazide followed the two-compartment model after a single dose .


The PK parameters of irbesartan were not affected by hydrochlorothiazide ; however irbesartan decreased the hydrochlorothiazide AUC by @ % and increased its clearance by @ % .


There were no significant changes in heart rate after each drug alone or in combination .


Irbesartan plus hydrochlorothiazide had a greater blood pressure lowering effect compared with irbesartan alone , despite the unchanged irbesartan PK .


The relationship between irbesartan plasma concentration and its effects plotted in chronological order showed anticlockwise hysteresis .


The PD parameter estimates for the effect of irbesartan on systolic blood pressure , when administered with hydrochlorothiazide were significantly different from those when irbesartan was administered alone .


This was manifested by a @ % increase in Emax , and a @ % decrease in EC@ , suggesting a synergistic blood pressure lowering effect for the combination .


While parameter estimates for the effect of irbesartan on diastolic blood pressure were changed by hydrochlorothiazide , the differences were only significant for EC@ .


A limited potential for clinically significant interactions between irbesartan and hydrochlorothiazide at the given doses were observed ; therefore , no dosage adjustments were recommended for either drug when used together .


( ClinicalTrials.gov Identifier NCT@ )


To investigate a saddle anesthesia with different doses of chloroprocaine in perianal surgery .


Total @ Patients aged @-@ years ( Anesthesiologists grade I or II ) scheduled to receive perianal surgery .


Patients using saddle anesthesia were randomized to group A , group B and group C with the same concentration ( @ % ) chloroprocaine with different doses @ mL , @ mL and @ mL , respectively .


Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate ( HR ) and the sensory and motor block were recorded to evaluate the anesthesia effect of chloroprocaine in each group .


The duration of sensory block of group C is shorter than those of group A and B.


The maximum degree of motor block is observed ( group C : @ level , group A : III level ; and group B : I level ) after @ minutes .


Besides , there was a better anesthetic effect in group B than group A and group C , such as walking after saddle anesthesia .


However , there is also no significant difference of blood pressure decreasing in these three groups .


It 's worth to employ a saddle anesthesia with appropriate doses of chloroprocaine in clinical perianal surgery .


Controlled somatosensory stimulation strategies have demonstrated merit in developing oral feeding skills in premature infants who lack a functional suck , however , the effects of orosensory entrainment stimulation on electrocortical dynamics is unknown .


The objective of the study was to determine the effects of servo-controlled pneumatic orocutaneous stimulation presented during gavage feedings on the modulation of amplitude-integrated electroencephalogram ( aEEG ) and range electroencephalogram ( rEEG ) activity .


Two-channel EEG recordings were collected during @ sessions that included orocutaneous stimulation and non-stimulation epochs among @ preterm infants ( mean gestational age = @ weeks ) who were randomized to treatment and control ` sham ' conditions .


The study was initiated at around @ weeks post-menstrual age .


The raw EEG was transformed into aEEG margins , and rEEG amplitude bands measured at @-min intervals and subjected to a mixed models statistical analysis .


Multiple significant effects were observed in the processed EEG during and immediately following @-min periods of orocutaneous stimulation , including modulation of the upper and lower margins of the aEEG , and a reorganization of rEEG with an apparent shift from amplitude bands D and E to band C throughout the @-min recording period that followed the first stimulus block when compared with the sham condition .


Cortical asymmetry also was apparent in both EEG measures .


Orocutaneous stimulation represents a salient trigeminal input , which has both short - and long-term effects in modulating electrocortical activity , and thus is hypothesized to represent a form of neural adaptation or plasticity that may benefit the preterm infant during this critical period of brain maturation .


Impaired pulmonary gas exchange after cardiac surgeries with cardiopulmonary bypass ( CPB ) often occurs , and the selection of mechanical ventilation mode , pressure-controlled ventilation ( PCV ) or volume-controlled ventilation ( VCV ) , may be important for preventing hypoxia and improving oxygenation .


The authors hypothesized that patients with PCV would show better oxygenation , compared with VCV , during one-lung ventilation ( OLV ) for mitral valve repair surgery ( MVP ) via thoracotomy .


Randomized controlled trial .


University teaching hospital .


Sixty patients in each group .


MVP was performed using thoracotomy with OLV by PCV or VCV .


Arterial partial pressure of oxygen ( PaO@ ) and fraction of inspired oxygen ( FIO@ ) were measured before anesthesia induction ( T@ ) , at skin incision ( T@ ) , after administration of heparin ( T@ ) , at @ minutes after CPB weaning ( T@ ) , just before departure from the operating room to the intensive care unit ( ICU ) ( T@ ) , and @ hour after ICU admission ( T@ ) , and PaO@/FIO@ ratio was calculated .


Peak inspiratory pressure ( PIP ) and mean inspiratory pressure ( Pmean ) were recorded at T@ , T@ , T@ , and T@ .


No significant difference was noted in the PaO@/FIO@ ratio between the groups at any measured point .


PIP in the PCV group at all measured points was lower than that in the VCV group ( T@ , p < @ ; T@ , p < @ ; T@ , p < @ ; T@ , p = @ , respectively ) .


Pmean was not different between the two groups at any measured point .


PCV during OLV in patients undergoing MVP via a thoracotomy with OLV showed lower PIP compared with VCV , but this did not improve pulmonary gas exchange .


Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis ( MS ) , which is caused by a widespread axonal degeneration .


Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism , axonal glutamate toxicity , and reduced cerebral blood flow .


Fluoxetine might theoretically reduce axonal degeneration in MS because it stimulates energy metabolism through enhancing glycogenolysis , stimulates the production of brain-derived neurotrophic factor , and dilates cerebral arterioles .


The current document presents the protocol of a clinical trial to test the hypothesis that fluoxetine slows down the progressive phase of MS.


The FLUOX-PMS trial is a multi-center , randomized , controlled and double-blind clinical study .


A total of @ patients with the diagnosis of either secondary or primary progressive MS will be treated either by fluoxetine ( @ mg daily ) or placebo for a total period of @ weeks .


The primary endpoint is the time to confirmed disease progression defined as either at least a @ % increase in the timed @-Foot Walk or at least a @ % increase in the @-Hole Peg Test .


Secondary endpoints include the Hauser ambulation index , cognitive changes , fatigue , magnetic resonance imaging of the brain , and in a small subgroup optical coherence tomography .


The FLUOX-PMS trial will gives us information as to whether fluoxetine has neuroprotective effects in patients with progressive MS.


The apolipoprotein A@ gene ( APOA@ ) -@ T > C polymorphism is associated with mild hypertriglyceridemia in type @ diabetic subjects , and interacts with dietary fat in the determination of triglyceride concentrations .


We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet ( about @ % of energy derived from carbohydrate ) may modify the effect of this variant on changes in apolipoprotein A-V ( apoA-V ) and triglyceride concentrations .


We genotyped the APOA@ -@ T > C in individuals with impaired fasting glucose ( IFG ) or newly diagnosed type @ diabetes , who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for @weeks .


After dietary intervention , we observed significant interactions between the APOA@ -@ T > C polymorphism and carbohydrate sources ( whole grains and legumes versus refined rice ) in the determination of mean percent changes in triglyceride and apoA-V ( P interactions < @ and = @ , respectively ) .


In the refined rice group ( n = @ ) , the carriers of the risk C allele ( n = @ ) showed a greater increase in the mean percent changes of triglyceride and apoA-V than noncarriers after adjusting for HOMA-IR ( P = @ and @ , respectively ) .


The whole grain and legume group ( n = @ ) , however , showed a decrease in fasting glucose , HOMA-IR , and triglyceride , and an increase in apoA-V , irrespective of genotype .


The data showed that the magnitude of the genetic effect of the APOA@ -@ C variant on triglyceride and apoA-V levels was modulated when substituting consumption of whole grains and legumes for refined rice as a carbohydrate source in IFG or diabetic subjects .


Most patients with facial scarring would value even a slight improvement in scar quality .


Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing .


The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds .


In this double-blinded , randomized , vehicle-controlled , prospective clinical trial , @ consecutive consenting adults undergoing cleft lip scar revision ( CLSR ) surgery between July @ and March @ were randomized to receive botulinum toxin A ( n = @ ) or vehicle ( normal saline ; n = @ ) injections into the subjacent orbicularis oris muscle immediately after wound closure .


Scars were independently assessed at @-months follow-up in blinded fashion using : Vancouver Scar Scale ( VSS ) , Visual Analogue Scale ( VAS ) and photographic plus ultrasound measurements of scar widths .


@ patients completed the trial .


All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group .


Quality of surgical upper lip scars , which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle , is significantly improved by its temporary paralysis during wound healing .


Evaluate the utility of @ electronic medical record ( EMR ) - linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications .


A @-year , parallel arm , pragmatic clinical trial in which @,@ adults were randomized to receive either usual care ( UC ) or @ of @ interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR + ) .


The interventions used automated phone reminders to increase adherence to cardiovascular disease medications .


The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes .


The study took place in @ large health maintenance organizations .


We enrolled participants who were @ years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent .


IVR participants received automated phone calls when they were due or overdue for a refill .


IVR + participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed materials .


Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( @ to @ percentage points ) .


Adherence to ACEIs/ARBs was also significantly higher for IVR + relative to IVR participants .


These differences persisted across subgroups .


Among statin users , IVR + participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( = -@ ; @ % CI , -@ to -@ mg/dL ) ; this effect was seen mainly in those with baseline LDL levels @ mg/dL ( = -@ ; @ % CI , -@ to -@ mg/dL ) .


Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors .


Ischaemia-reperfusion injury following acute myocardial infarctions ( AMI ) is an unavoidable consequence of the primary percutaneous coronary intervention ( pPCI ) procedure .


A pivotal mechanism in ischaemia-reperfusion injury is the production of reactive oxygen species following reperfusion .


The endogenous hormone , melatonin , works as an antioxidant and could potentially minimise the ischaemia-reperfusion injury .


Given intracoronarily , it enables melatonin to work directly at the site of reperfusion .


We wish to test if melatonin , as an antioxidant , can minimise the reperfusion injury following pPCI in patients with AMI .


The IMPACT trial is a multicentre , randomised , double-blinded , placebo-controlled study .


We wish to include @ @ patients with ST-elevation myocardial infarctions undergoing pPCI within six hours from symptom onset .


The primary end-point is the Myocardial Salvage Index assessed by cardiovascular magnetic resonance imaging on day @ ( @ ) after pPCI .


The secondary end-points are high-sensitivity troponin , creatinekinase myocardial band and clinical events .


The aim of the IMPACT trial is to evaluate the effect of melatonin on reperfusion injuries following pPCI .


Owing to its relatively non-toxic profile , melatonin is an easily implementable drug in the clinical setting , and melatonin has the potential to reduce morbidity in patients with AMI .


The public typically believes psychotherapy to be more effective than pharmacotherapy for depression treatments .


This is not consistent with current scientific evidence , which shows that both types of treatment are about equally effective .


The study investigates whether this bias towards psychotherapy guides online information search and whether the bias can be reduced by explicitly providing expert information ( in a blog entry ) and by providing tag clouds that implicitly reveal experts ' evaluations .


A total of @ participants completed a fully automated Web-based study after we invited them via mailing lists .


First , participants read two blog posts by experts that either challenged or supported the bias towards psychotherapy .


Subsequently , participants searched for information about depression treatment in an online environment that provided more experts ' blog posts about the effectiveness of treatments based on alleged research findings .


These blogs were organized in a tag cloud ; both psychotherapy tags and pharmacotherapy tags were popular .


We measured tag and blog post selection , efficacy ratings of the presented treatments , and participants ' treatment recommendation after information search .


Participants demonstrated a clear bias towards psychotherapy ( mean @ , SD @ ) compared to pharmacotherapy ( mean @ , SD @ ; t@ = @ , P < @ , d = @ ) when rating treatment efficacy prior to the experiment .


Accordingly , participants exhibited biased information search and evaluation .


This bias was significantly reduced , however , when participants were exposed to tag clouds with challenging popular tags .


Participants facing popular tags challenging their bias ( n = @ ) showed significantly less biased tag selection ( F@ ,@ = @ , P < @ , partial eta squared = @ ) , blog post selection ( F@ ,@ = @ , P = @ , partial eta squared = @ ) , and treatment efficacy ratings ( F@ ,@ = @ , P < @ , partial eta squared = @ ) , compared to bias-supporting tag clouds ( n = @ ) and balanced tag clouds ( n = @ ) .


Challenging ( n = @ ) explicit expert information as presented in blog posts , compared to supporting expert information ( n = @ ) , decreased the bias in information search with regard to blog post selection ( F@ ,@ = @ , P = @ , partial eta squared = @ ) .


No significant effects were found for treatment recommendation ( Ps > @ ) .


We conclude that the psychotherapy bias is most effectively attenuated-and even eliminated-when popular tags implicitly point to blog posts that challenge the widespread view .


Explicit expert information ( in a blog entry ) was less successful in reducing biased information search and evaluation .


Since tag clouds have the potential to counter biased information processing , we recommend their insertion .


Several combined spinal-epidural ( CSE ) anesthesia techniques have been described .


This study was designed to compare the single space ( `` needle-through-needle '' ) technique ( SST ) and the double distant space technique ( DDS ) with regards to the time needed for the procedure , patient discomfort during the procedure and patient 's preference technique .


This prospective , randomized single-blind study included @ patients undergoing colorectal surgery under general anesthesia and CSE .


All neuraxial blocks were performed before general anesthesia induction .


DDS group of patients had thoracic epidural catheter placed at T@-@ or T@-@ , followed by subarachnoid injection at the L@-@ interspace .


The SST group of patients had a single injection using the needle-through-needle technique ( Espocan needle ) at L@-@ .


The epidural catheter was used for postoperative analgesia for @ hours .


Body habitus , spinal anatomy and spinal landmarks were assessed preoperatively .


The number of epidural and spinal punctures , the feeling that the dura is perforated ( dural perforation click ) and the time needed to perform CSE were also recorded .


Complications during epidural catheter placement and perioperative and postoperative epidural catheter function and patient preference for the anesthetic procedure were recorded .


Epidural and subarachnoid spaces were successfully identified in all the patients .


Duration of CSE procedure , the number of spinal punctures , dural click feeling and the effects of test dose did not differ between the groups .


The patients in both groups ( @ % of DDS and @ % of SST ) would choose CSE as preferred method in the future .


The CSE procedure was painful for @ % of DDS vs @ % of SST patients .


A significant correlation between time needed for CSE technique performance and body habitus ( r = @ , p < @ ) , spinal landmarks ( r = @ , p < @ ) and anatomy ( r = @ , p < @ ) was found in the SST group .


There was no correlation between the number of epidural/spinal punctures and epidural bacteriological findings .


There was no correlation between the patients ' choice of the CSE technique and the number of spinal punctures , duration of CSE procedure and epidural catheter stay .


The two CSE techniques did not differ with regards to the procedure time and patient 's preference .


Procedure time correlated with body habitus , spinal landmarks and the anatomy in the SST group .


To assess the effect of analgesia at disbudding on weight gain and milk intake of dairy calves .


Four disbudding protocols were used on @ - to @-week-old Friesian-Jersey calves .


Farm staff disbudded @ calves without sedation or local analgesia , of which @ received @mg meloxicam S/C .


Veterinary staff disbudded @ calves with sedation and local analgesia , of which @ also received @mg meloxicam S/C .


Calves were weighed before disbudding , @ and @ days later , and individual milk consumption was recorded for @ days .


Daily weight gain and milk consumption were analysed using mixed models and ANOVA .


From disbudding ( Day @ ) to Day @ farmer-disbudded calves receiving meloxicam grew faster ( @ kg/day ) than calves without meloxicam ( @ kg/day ; p = @ ) , but an interaction between operator and meloxicam treatment ( p = @ ) meant that meloxicam treatment did not increase growth rates in veterinary-disbudded calves ( @ vs. @ kg/day ; p = @ ) .


From Days @-@ there was no significant effect of meloxicam on growth rate , but veterinarian-disbudded calves grew faster ( @ kg/day ) than farmer-disbudded calves ( @ kg/day ; p = @ ) .


Overall , for the first @ days after disbudding , if meloxicam was not used ' , veterinarian-disbudded calves grew faster than farmer-disbudded calves ( p = @ ) .


However if meloxicam was used at disbudding there was no difference in growth rate between veterinarian - and farmer-disbudded calves ( p = @ ) .


Mean cumulative milk consumption for the @ days after disbudding was greater for calves disbudded by veterinary staff than by farm staff ( p < @ ) , but there was no effect of meloxicam treatment ( p = @ ) and no interaction with operator ( p = @ ) on cumulative milk consumption .


Three to @-week-old dairy calves disbudded by farm staff with no analgesia grew significantly slower over the next @ days than farmer-disbudded calves given meloxicam , and slower over the next @ days than veterinarian-disbudded calves given xylazine and lignocaine .


However addition of meloxicam to the latter protocol had no effect on growth rate .


Milk intake was significantly higher for @ days for veterinarian - compared with farmer-disbudded calves .


This study adds to the evidence that analgesia during disbudding is beneficial for calf productivity as well as calf welfare .


The double balloon enteroscopy ( DBE ) procedure is long and requires moderate sedation .


We aim to determine whether the administration of propofol infusion is safe by comparing it to intravenous midazolam/meperidine in patients undergoing DBE .


A prospective study with @ patients was conducted at King Chulalongkorn Hospital randomizing ( block of four ) patients into two groups .


In group @ , @ patients were enrolled for intravenous midazolam/meperidine , and one patient was dropped out before underwent DBE due to hemodynamic instability .


Therefore , @ ( n = @ ) participants were included in Group @ .


In group @ , @ patients were enrolled for propofol infusion , and seven patients were dropped out before underwent DBE , five due to hemodynamic instability ( n = @ ) , and two refused treatment ( n = @ ) .


Vital signs and oxygen saturation were regularly monitored .


Mean + / - SD age of patients was @ + / - @ years , and @ % of patients were male .


There was no difference in demographic data between the groups .


For the safety profile , @ % of the midazolam/meperidine group and @ % of the propofol group developed hypotension and/or desaturation ( p = @ ) .


The patients ' satisfaction of group @ and group @ were @ + / - @ % and @ + / - @ % , respectively , and presented no significant difference ( p = @ ) .


Propofol infusion is safe and shows no difference in outcome from the midazolam and meperidine sedation for the DBE procedure .


To evaluate the efficacy of cytoflavin in the treatment of patients with hypertensive encephalopathy ( HE ) .


One hundred and forty patients aged @ to @ years , diagnosed with HE , were examined and randomized to @ groups .


A study group ( n = @ ) received cytoflavin in a dose of @ tablets b.i.d. on days @ to @ days inclusive during standard basic therapy .


A comparison group ( n = @ persons ) had standard basic therapy only .


A control group consisted of @ apparently healthy individuals .


The investigators studied the frequency of headache , dizziness , and other complaints and the intensity of cephalalgic syndrome , by using a visual analog scale , the quality of life by the Medical Outcomes Study @-Item Short-Form Health Survey ( MOS SF-@ ) questionnaire , that of sleep by the subjective sleep characteristics questionnaire elaborated at the Moscow City Somnological Center , the level of asthenia by a subjective asthenia rating scale ( Multidimensional Fatigue Inventory ( MFI-@ ) , and autonomic status , by applying objective and subjective scales on days @ and @ of therapy .


The study has shown that cytoflavin used in the above dose for @ days reduces the frequency and magnitude of complaints of headache , dizziness , `` venous '' complaints , the degree of autonomic and asthenic disorders , and impairments in the quality of sleep and life in the patients with HE at all disease stages .


A stepwise discriminant analysis has indicated that the degree of cephalgic syndrome , and autonomic disorders , and worse sleep quality are the most effective points for using the energy-modifier cytoflavin .


HE treatment based on the current pathogenetic principles may have a preventive impact on the development of HE or slow down the rate of its progression .


Local failure after radical prostatectomy ( RP ) is common in patients with cancer extending beyond the capsule .


Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy ( ART ) compared with a wait-and-see ( WS ) policy .


To determine the efficiency of ART after a @-yr follow-up in the ARO @-@ study .


After RP , @ patients with pT@ pN@ prostate cancer ( PCa ) were randomized to WS or three-dimensional conformal ART with @ Gy .


The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP ( ITT@ population ) -- that is , @ WS plus @ ART men .


The primary end point of the study was progression-free survival ( PFS ) ( events : biochemical recurrence , clinical recurrence , or death ) .


Outcomes were compared by log-rank test .


Cox regression analysis served to identify variables influencing the course of disease .


The median follow-up was @ mo for ART and @ mo for WS .


At @ yr , PFS was @ % for ART and @ % for WS ( p < @ ) .


In pT@b and R@ patients , the rates for WS even dropped to @ % and @ % , respectively .


Of all @ ITT@ patients , @ died from PCa , and @ died for other or unknown reasons .


Neither metastasis-free survival nor overall survival was significantly improved by ART .


However , the study was underpowered for these end points .


The worst late sequelae in the ART cohort were one grade @ and three grade @ cases of bladder toxicity and two grade @ cases of rectum toxicity .


No grade @ events occurred .


Compared with WS , ART reduced the risk of ( biochemical ) progression with a hazard ratio of @ in pT@ PCa .


With only one grade @ case of late toxicity , ART was safe .


Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors .


The aim of this work was to assess the prognostic value of absolute N-terminal-pro-B-type natriuretic peptide ( NT-proBNP ) concentration in combination with changes during admission because of acute heart failure ( AHF ) and early after hospital discharge .


In AHF , readmission and mortality rates are high .


Identifying those at highest risk for events early after hospital discharge might help to select patients in need of intensive outpatient monitoring .


We evaluated the prognostic value of NT-proBNP concentration on admission , at discharge , @month after hospital discharge and change over time in @ patients included in the PRIMA ( Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality ? )


study .


Primary outcome measures were mortality and the combined end point of heart failure ( HF ) readmission or mortality .


In a multivariate Cox regression analysis , change in NT-proBNP concentration during admission , change from discharge to @month after discharge , and the absolute NT-proBNP concentration at @ month after discharge were of independent prognostic value for both end points ( hazard ratios for HF readmission or mortality : @ , @ % confidence interval -LSB- CI -RSB- @-@ @ , Wald @ -LSB- P = @ -RSB- versus @ , @ % CI @-@ @ , Wald @ -LSB- P < @ -RSB- versus @ , @ % CI @-@ @ , Wald @ -LSB- P = @ -RSB- , respectively .


Knowledge of change in NT-proBNP concentration during admission because of AHF in combination with change early after discharge and the absolute NT-proBNP concentration at @ month after discharge allows accurate risk stratification .


Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator ( ICD ) therapy in primary prevention patients .


Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III ( ADVANCE III ) was the only trial that enrolled both primary and secondary prevention patients .


Of the @ patients enrolled in the ADVANCE III trial , @ received a defibrillator for secondary prevention ; @ patients were randomly assigned to a long detection setting ( @ of @ intervals ) and @ to the nominal setting ( @ of @ intervals ) for ventricular arrhythmias with cycle length @ ms. Eight-five percent of patients were men , with a mean age of @ @ years , a previous history of ventricular fibrillation in @ % of the cases , and a mean ejection fraction of @ @ % .


The ICD device mix was @ % single chamber , @ % dual chamber , and @ % triple chamber .


Over a median period of @ months , the long detection period was associated with a @ % reduction in the number of overall therapies ( @ versus @ per @ patient-years ; incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) and a @ % reduction in the number of shocks ( rate per @ patient-years , @ versus @ ; incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Appropriate therapies ( @ versus @ ; incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) and appropriate shocks ( @ versus @ ; incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) were also reduced .


ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients .


These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging .


Prospective , double-blind study , randomized control trial .


To evaluate and compare the analgesic efficacy , adverse effects , and clinical utility of gabapentin and pregabalin in postoperative pain management , long-term functional outcome , and quality of life in patients undergoing spinal surgery .


Patient outcome after lumbar discectomy for radicular low back pain is variable and the benefit is inconsistent .


The most common persistent symptoms are pain , motor deficit , and decreased functional status .


This study was conducted in @ patients belonging to the @ to @ age group of either sex undergoing spinal surgery under general anesthesia .


Group A received @ mg of gabapentin , group B received @ mg of pregabalin , whereas group C received placebo @ dose @ hour before surgery and @ hourly for @ days , thereafter .


The outcome of postoperative static and dynamic pain and functional outcome was recorded using @ questionnaires-visual analogue scale , Prolo functional and economic score , Oswestry Disability Index score from preoperative period to @ months postoperatively .


Among the @ groups , subjects receiving pregabalin showed consistently reduced static and dynamic pain intensity and also required lesser amount of rescue drug throughout the postoperative period .


There was statistically significant difference ( P < @ ) in the Prolo score and Oswestry Disability Index score at all time intervals between group B and group C. Although , significant difference in the functional outcome between group A and group B was seen at @ months .


Preoperative pregabalin administration is associated with less pain intensity and improved functional outcomes @ months after lumbar discectomy followed by gabapentin and then placebo .


Limited data exist regarding the proarrhythmic effects of smoking .


To evaluate the relationship between smoking and the risk of first and recurrent ventricular tachyarrhythmias ( VTAs ) in patients with mild heart failure .


The risk of a first and recurrent appropriate implantable cardioverter-defibrillator therapy for VTAs or death was compared between nonsmokers ( n = @ ) , past smokers ( n = @ ) , and current smokers ( n = @ ) in patients with ischemic and nonischemic cardiomyopathy who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy study .


The cumulative probability of a first VTA or death was significantly higher in current smokers than in past and nonsmokers ( P < @ ) .


Multivariate analysis showed that current smokers had a significantly higher risk of first ventricular tachycardia/ventricular fibrillation or death ( hazard ratio -LSB- HR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; P = @ ) and a higher risk for first ventricular tachycardia/ventricular fibrillation episode ( HR @ , @ % CI @-@ @ , P = @ ) than did nonsmokers .


Past smokers had a risk of first VTAs or death similar to that of nonsmokers ( HR @ ; @ % CI @-@ @ ; P = @ ) .


In comparison to nonsmokers , the risk of recurrent VTAs was significantly higher in the total cohort of patients ( HR @ ; @ % CI @-@ @ ; P < @ ) and in the subgroups of patients with ischemic and nonischemic cardiomyopathy ( HR @ ; @ % CI @-@ @ ; P = @ ) .


Current smokers with left ventricular dysfunction and mild heart failure are at a significantly higher risk of VTAs or death than are past smokers and nonsmokers .


Smoking is associated with a significant increase in the risk of recurrent VTAs in both patients with ischemic and nonischemic cardiomyopathy .


Refining leaflet reconstruction has become a primary issue in aortic valve repair .


This descriptive analysis reviews leaflet pathology , repair techniques , and early results in a prospective regulatory trial of aortic valve repair .


Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency ( AI ) .


The mean age was @ @ years , and @ % of the patients were male .


Ascending aortic/root replacement was required in @ % .


As a first step , ring annuloplasty was performed , and then leaflet repair included leaflet plication for prolapse , nodular unfolding , double pericardial patching of commissural defects or holes , complete pericardial leaflet replacement , leaflet extension , and Gore-Tex reinforcement .


Leaflet techniques and causes of adverse outcomes were evaluated .


The follow-up time was @-years maximal and @ years mean , with a survival of @ % .


Eighty percent of patients required repair of leaflet defects : leaflet prolapse ( @/@-@ % ) , ruptured commissures ( @/@ -@ % ) , leaflet holes ( @/@ -@ % ) , and nodular retraction ( @/@ -@ % ) .


The average preoperative AI grade of @ @ fell to @ @ ( p < @ ) .


Three patients ( @ % ) required interval valve replacement because of ( @ ) suture untying , ( @ ) iatrogenic leaflet tear , or ( @ ) diphtheroid endocarditis .


Five other patients experienced grade @ or grade @ AI : probable suture untying in @patient , ineffective leaflet extensions in @ patients , and unsuccessful Gore-Tex reinforcements in@patients .


Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well .


Leaflet defects are common in patients with moderate to severe AI .


Leaflet plication , nodular unfolding , and double pericardial patching performed well .


Gore-Tex and leaflet extension seemed less satisfactory .


Standardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair .


We hypothesize that limited transthoracic echocardiogram ( LTTE ) is a useful tool to guide therapy during the initial phase of resuscitation in trauma patients .


All highest-level alert patients with at least one measurement of systolic blood pressure less than @ mm Hg , a mean arterial pressure less than @ mm Hg , and/or a heart rate greater than @ beats per minute who arrived to the trauma bay ( TB ) were randomized to have either LTTE performed ( LTTEp ) or not performed ( non-LTTE ) as part of their initial evaluation .


Images were stored , and results were reported regarding contractility ( good vs. poor ) , fluid status ( empty inferior vena cava -LSB- hypovolemic -RSB- vs. full inferior vena cava -LSB- not hypovolemic -RSB- ) , and pericardial effusion ( present vs. absent ) .


Time from TB to operating room , intravenous fluid administration , blood product requirement , intensive care unit admission , and mortality were examined in both groups .


A total of @ patients were randomized .


Twenty-five patients were excluded since they died upon arrival to the TB , leaving @ patients in the study .


Ninety-two patients were in the LTTEp group with @ patients in the non-LTTE group .


The LTTEp and non-LTTE groups were similar in age ( @ years vs. @ years , p = @ ) , Injury Severity Score ( ISS ) ( @ vs. @ , p = @ ) , Revised Trauma Score ( RTS ) ( @ vs. @ , p = @ ) , lactate ( @ vs. @ , p = @ ) , and mechanism of injury ( p = @ ) .


Strikingly , LTTEp had significantly less intravenous fluid than non-LTTE patients ( @ L vs. @ L , p < @ ) , less time from TB to operating room ( @ minutes vs. @ min , p = @ ) , higher rate of intensive care unit admission ( @ % vs. @ % , p = @ ) , and a lower mortality rate ( @ % vs. @ % , p = @ ) .


Mortality differences were particularly evident in the traumatic brain injury patients ( @ % in LTTEp vs. @ % in non-LTTE , p = @ ) .


LTTE is a useful guide for therapy in hypotensive trauma patients during the early phase of resuscitation .


Therapeutic study , level II .


Our goal is to conduct a multicenter randomized controlled trial ( RCT ) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged @ years with a vertebral fracture .


This pilot study will determine the feasibility of recruitment , retention , and adherence for the proposed trial .


The proposed RCT will be a pilot feasibility study with @:@ randomization to exercise or attentional control groups .


Five Canadian sites ( @ community hospital partnered with an academic center and @ academic hospitals or centers affiliated with an academic center ) and @ Australian centers ( @ academic hospital and @ center for community primary care , geriatric , and rehabilitation services ) .


One hundred sixty women aged @ years with vertebral fracture at @ Canadian and @ Australian centers will be recruited .


The Build Better Bones With Exercise ( B@E ) intervention includes exercise and behavioral counseling , delivered by a physical therapist in @ home visits over @ months , and monthly calls ; participants are to exercise @ times weekly .


Controls will receive equal attention .


Primary outcomes will include recruitment , retention , and adherence .


Adherence to exercise will be assessed via calendar diary .


Secondary outcomes will include physical function ( lower extremity strength , mobility , and balance ) , posture , and falls .


Additional secondary outcomes will include quality of life , pain , fall self-efficacy , behavior change variables , intervention cost , fractures , and adverse events .


Analyses of feasibility objectives will be descriptive or based on estimates with @ % confidence intervals , where feasibility will be assessed relative to a priori criteria .


Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests , chi-square tests , or logistic regression .


The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is @ .


No assessment of bone mineral density will be conducted .


The proposed definitive trial will require a large sample size .


The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated , as well as the effects of a home exercise program on important secondary outcomes .


Abiraterone acetate , an androgen biosynthesis inhibitor , prolongs survival in men with metastatic castration-resistant prostate cancer ( mCRPC ) in the pre - and post-chemotherapy setting as demonstrated by the pivotal phase III studies COU-AA-@ and COU-AA-@ .


We performed population pharmacokinetic analyses to estimate pharmacokinetic parameters after oral administration of @,@ mg/day of abiraterone acetate in patients with mCRPC , with or without prior chemotherapy , and after a single @,@ mg dose in healthy volunteers .


The study objectives were to determine consistency between patient populations and to characterize factors that may influence abiraterone pharmacokinetics .


Studies in this analysis included COU-AA-@ ( chemotherapy nave ) ; COU-AA-@ and COU-AA-@ ( chemotherapy pretreated ) ; and COU-AA-@ , COU-AA-@ , and COU-AA-@ ( healthy subjects ) .


A total of @,@ plasma concentrations from @ subjects ( @ healthy volunteers , @ patients ) were analyzed using non-linear mixed-effects modeling .


An Erlang-type absorption model with first-order elimination and three-transit compartments following sequential zero - and first-order processes was used to characterize abiraterone pharmacokinetics .


Absorption-related parameters were affected by food intake .


Abiraterone pharmacokinetics were characterized by an extensive apparent clearance , which was lower in patients with mCRPC ( @,@ L/h ) versus healthy subjects ( @,@ L/h ) , and by large apparent central ( @,@ L ) and peripheral ( @,@ L ) volumes of distribution .


Abiraterone pharmacokinetics were similar in chemotherapy-pretreated and - nave patients and were characterized by a high between - and within-subject variability -LSB- e.g. , between-subject coefficient of variation ( CV % ) for relative bioavailability for the modified fasting state was @ % and the CV % for within-subject variability was @ % -RSB- .


The fat content of food taken with abiraterone acetate affected the bioavailability of abiraterone .


No factors beyond food intake and health status ( healthy vs. mCRPC ) impacted abiraterone pharmacokinetics .


Based on the pharmacokinetics model , the recommended @,@ mg/day of abiraterone acetate resulted in similar abiraterone exposure for patients with mCRPC regardless of prior chemotherapy .


The fat content of food affected relative bioavailability of abiraterone , though the extent of this effect is dependent on health status .


The appropriate caloric goal for critically ill adults is unclear .


We evaluated the effect of restriction of nonprotein calories ( permissive underfeeding ) , as compared with standard enteral feeding , on @-day mortality among critically ill adults , with maintenance of the full recommended amount of protein in both groups .


At seven centers , we randomly assigned @ critically ill adults with a medical , surgical , or trauma admission category to permissive underfeeding ( @ to @ % of calculated caloric requirements ) or standard enteral feeding ( @ to @ % ) for up to @ days while maintaining a similar protein intake in the two groups .


The primary outcome was @-day mortality .


Baseline characteristics were similar in the two groups ; @ % of the patients were receiving mechanical ventilation .


During the intervention period , the permissive-underfeeding group received fewer mean ( SD ) calories than did the standard-feeding group ( @ kcal per day vs. @ kcal per day , P < @ ; @ % vs. @ % of caloric requirements , P < @ ) .


Protein intake was similar in the two groups ( @ g per day and @ g per day , respectively ; P = @ ) .


The @-day mortality was similar : @ of @ patients ( @ % ) in the permissive-underfeeding group and @ of @ patients ( @ % ) in the standard-feeding group died ( relative risk with permissive underfeeding , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


No serious adverse events were reported ; there were no significant between-group differences with respect to feeding intolerance , diarrhea , infections acquired in the intensive care unit ( ICU ) , or ICU or hospital length of stay .


Enteral feeding to deliver a moderate amount of nonprotein calories to critically ill adults was not associated with lower mortality than that associated with planned delivery of a full amount of nonprotein calories .


( Funded by the King Abdullah International Medical Research Center ; PermiT Current Controlled Trials number , ISRCTN@ . )


Lobeglitazone , a peroxisome proliferator-activated receptor - agonist , is metabolized primarily by the cytochrome P@ ( CYP ) @A@ isoenzyme .


Individuals concomitantly taking lobeglitazone and a CYP@A@ inhibitor may experience some adverse effects secondary to increased systemic exposure to lobeglitazone .


To address such potential concern , we evaluated the effects of ketoconazole , a prototypic CYP@A@ inhibitor , on the pharmacokinetic ( PK ) properties and associated adverse effects of lobeglitazone .


A PK drug-drug interaction study was conducted in healthy individuals between @ and @ years old in a randomized , open-label , @-way crossover design .


Even though the PK study was performed on a single dose of lobeglitazone , multiple ketoconazole doses were given to ensure that the full extent of inhibition of CYP@A@ was maintained during the PK sampling .


All study participants received a single oral dose of lobeglitazone @ mg with or without @ oral @-mg doses of ketoconazole pretreatment twice daily .


The primary PK parameter end points ( AUC and Cmax ) were estimated using noncompartmental analysis , and the @ % CIs for the geometric mean ratios ( ratio of lobeglitazone and ketoconazole to lobeglitazone alone ) were investigated .


Tolerability ( adverse events , vital signs , ECG , and laboratory tests ) was also assessed .


A total of @ Korean men ( mean age , @ years ; age range , @-@ years ; mean weight , @ kg ; weight range , @-@ kg ) completed the study and were evaluable for lobeglitazone PK properties and tolerability .


The mean ( SD ) Cmax values of lobeglitazone with and without ketoconazole were @ ( @ ) ng/mL and @ ( @ ) ng/mL at @ and @ hours after dosing , respectively .


The mean ( SD ) AUC values were @ ( @ ) ngh/mL and @ ( @ ) ngh/mL , respectively .


Although the Cmax was not significantly affected , the geometric mean ratio for AUC was increased by a point estimate of @ ( @ % CI , @-@ @ ) .


A single oral administration of lobeglitazone @ mg with or without ketoconazole pretreatment did not produce any clinically significant adverse effects on vital signs , @-lead ECG profiles , or laboratory tests .


The administration of lobeglitazone , @ mg alone or in combination with multiple doses of ketoconazole , was generally well tolerated .


The systemic exposure of lobeglitazone was increased to a modest extent by pretreatment with @ twice-daily doses of ketoconazole .


Clinicaltrials.gov identifier : NCT@ .


Survivin is a member of the inhibitor-of-apoptosis family .


Essential for tumor cell survival and overexpressed in most cancers , survivin is a promising target for anti-cancer immunotherapy .


Immunogenicity has been demonstrated in multiple cancers .


Nonetheless , few clinical trials have demonstrated survivin-vaccine-induced immune responses .


This phase I trial was conducted to test whether vaccine EMD@ , a cocktail of five HLA class I-binding survivin peptides in Montanide ( ) ISA @ VG , promotes anti-survivin T-cell responses in patients with solid cancers .


The primary objective was to compare immunologic efficacy of EMD@ at doses of @ , @ , and @ g. Secondary objectives included safety , tolerability , and clinical efficacy .


In total , @ patients who received @ EMD@ injections with available baseline - and @ post-vaccination samples -LSB- immunologic-diagnostic ( ID ) - intention-to-treat -RSB- were analyzed by ELISpot - and peptide/MHC-multimer staining , revealing vaccine-activated peptide-specific T-cell responses in @ patients ( @ % ) .


This cohort included the per study protocol relevant ID population for the primary objective , i.e. , T-cell responses by ELISpot in @ weeks following first vaccination , as well as subjects who discontinued the study before week @ but showed responses to the treatment .


No dose-dependent effects were observed .


In the majority of patients ( @ % ) , anti-survivin responses were detected only after vaccination , providing evidence for de novo induction .


Best overall tumor response was stable disease ( @ % ) .


EMD@ was well tolerated ; local injection-site reactions constituted the most frequent adverse event .


Vaccination with EMD@ elicited T-cell responses against survivin peptides in the majority of patients , demonstrating the immunologic efficacy of EMD@ .


Physiotherapy is integral to modern trauma care .


Early physiotherapy and mobility have been shown to improve outcomes in patients with isolated injuries ; however , the optimal intensity of physiotherapy in the multitrauma patient population has not yet been examined .


The primary aim of this study was to determine whether an intensive physiotherapy program resulted in improved inpatient mobility .


We conducted a single-center prospective randomized controlled study of @ consecutive patients admitted to the Alfred Hospital ( a Level @ trauma center ) in Australia between October @ and June @ who could participate in ward-based physiotherapy .


Participants were allocated to either usual care ( daily physiotherapy treatment , approximately @ minutes ) or intensive physiotherapy ( usual care plus two additional @-minute treatments each day ) .


The primary outcome measure was the modified Iowa Level of Assistance ( mILOA ) score , collected by a blinded assessor at Days @ and @ ( or earlier if discharged ) .


Secondary measures included physical readiness for discharge , hospital and rehabilitation length of stay , a patient confidence and satisfaction scale , and quality of life at @ months .


Groups were comparable at baseline .


Participants in the intensive physiotherapy group achieved significantly improved mILOA scores on Day @ ( median , @ points compared with @ points ; p = @ ) and Day @ ( median , @ points compared with @ points ; p = @ ) and were more satisfied with their care ( p = @ ) .


There was no difference between groups in time to physical readiness , discharge destination , length of stay , or quality-of-life measures .


Intensive physiotherapy resulted in improved mobility in trauma inpatients .


Further studies are required to determine if specific groups benefit more from intensive physiotherapy and if this translates to long-term improvements in outcomes .


Therapeutic study , level @ .


Uncertainty may limit communication and affect the ability of patients to adapt to their illness .


A high level of uncertainty in patients concurrent with sudden hearing loss has been related to poor comprehension of communications and poor illness understanding .


Currently , there is no any certain standard information sheet in the clinical setting .


This study evaluates the effect of a one-to-one oral instruction strategy combined with an information sheet firstly on the stimuli frame and then on uncertainty in patients suffering from idiopathic sudden sensorineural hearing loss .


An experimental design was employed and @ patients were randomly assigned to either the experimental group ( n = @ ) or the control group ( n = @ ) .


A structured questionnaire that included the stimuli frame of uncertainty and the Mishel uncertainty illness scale was used to collect data .


All samples received regular care following admission to the hospital and received the pretest within @ hours after admission .


The experimental group received the one-to-one oral instruction strategy combined with an information sheet immediately after the pretest .


All participants completed the posttest three days later .


The health education program increased perceived understanding of illness in patients with the sudden hearing loss , and reduced their illness uncertainty .


Perceived understanding of illness was negatively related to the level of illness uncertainty .


The stimuli frame of uncertainty acted as a mediator between the intervention and the uncertainty .


The intervention increased the level of cognition of the stimuli frame of uncertainty and then indirectly lowered the uncertainty level .


These findings support the effectiveness of the individual health education strategy with the information sheet in delivering to patients critical information about their condition and treatment .


Moreover , this intervention may effectively increase illness cognition and reduce uncertainty in patients with sudden hearing loss .


Clinical nurse staffs may use the findings of this study to improve their health education efficacy .


Preterm labor and delivery are of the most important complications of pregnancy and have a major role in neonatal mortality and morbidity .