After subcutaneous injection insulin glargine is rapidly metabolized to M@ and M@ .


In vitro , both M@ and M@ have metabolic effects and bind to IGF-@R similarly to human insulin , whereas glargine exhibits a higher affinity for the IGF-@R and greater mitogenetic effects .


The present study was specifically designed to establish the dose-response metabolism of glargine over @ h following s.c. injection in T@DM subjects on long-term use of glargine .


Ten subjects with T@DM were studied during @ h after s.c. injection of @ ( therapeutic ) and @ ( high dose ) U/kg of glargine on two separate occasions during euglycaemic clamps ( cross-over design ) .


Glargine , M@ and M@ over @ h period were determined in appropriately processed plasma samples by a specific liquid chromatography-tandem mass spectrometry assay .


Plasma M@ concentration ( AUC@-@ h ) was detected in all subjects and increased by increasing the glargine dose from therapeutic to high dose ( p = @ ) .


Glargine was detectable in @ ( therapeutic dose ) and @ ( high dose ) out of the @ subjects and also increased by increasing the dose ( p = @ ) .


However , glargine concentration ( AUC@-@ h -- high dose ) represented at most only @ % ( @-@ % ) of the total amount of insulin measured in the blood .


M@ was not detected at all .


In T@DM people on long-term use of insulin glargine , even with higher doses ( @ U/kg ) , glargine is nearly totally metabolized to the active metabolite M@ .


Glargine is often detectable in plasma , but its concentration remains well below that needed in vitro to potentiate IGF-@R binding and mitogenesis .


The main aim of this pilot study was to investigate an advanced version of eye movement desensitization and reprocessing ( EMDR ) for reducing anxiety .


Fifty participants were asked at two times of measurement ( T@ and T@ with a rest of @ weeks ) to generate anxiety via the recall of autobiographical memories according to their anxiety .


Furthermore , the participants were randomly assigned to an experimental group and a control group , and the experimental group received an intervention of @-@ h with the advanced version of EMDR in order to their anxiety @ weeks after T@ .


At T@ as well as T@ , we measured the intensity of participants ' anxiety with a Likert scale ( LS ) and collected participants ' state ( temporary ) and trait ( chronic ) anxiety with the State-Trait Anxiety Inventory ( STAI ) .


In addition , we measured participants ' physical performance in a test for the finger musculature under the induction of their anxiety .


The results showed that participant 's ratings of their perceived intensity of anxiety ( measured by a @-point LS ) and the state and trait anxiety decreased significantly in the experimental group but not in the control group from T@ to T@ .


Moreover , the physical performance under the induction of participants ' anxiety increased significantly in the experimental group from T@ to T@ and there were no significant changes in the control group .


The study could show that the advanced version of EMDR is an appropriate method to reduce anxiety .


Identification of novel biomarkers of diabetes risk help to understand mechanisms of pathogenesis and improve risk prediction .


Our objectives were to examine the relationships between adipokines , biomarkers of inflammation and endothelial function and development of type @ diabetes ; and to assess the relevance of including these biomarkers in type @ diabetes prediction risk models .


@ subjects from the SU.VI.MAX study , who were free of diabetes at baseline and who completed @ years of follow-up were included in the present analyses .


Odds ratios ( OR ) with @ % confidence intervals ( @ % CI ) of incident type @ diabetes associated with a @-SD increase in adiponectin , leptin , C-reactive protein ( CRP ) , soluble intracellular adhesion modecule-@ ( sICAM-@ ) , soluble vascular cell adhesion molecule @ ( sVCAM-@ ) , E-selectin and monocyte chemoattractant protein-@ ( MCP-@ ) were estimated .


Predicitive performances of models including biomarkers were assessed with area under the receiver operating curves ( AUC ) and integrated discrimination improvement ( IDI ) statistics .


@ subjects developed type @ diabetes during follow-up .


The risk of developing type @ diabetes increased with increasing concentrations of leptin ( @ ( @ ; @ ) ) , sICAM-@ ( @ ( @ ; @ ) ) and sVCAM-@ ( @ ( @ ; @ ) ) .


Type @ diabetes associations with leptin remained significant after adjusting for a combination of biomarkers .


Models adjusted for novel biomarkers had improved performance compared to models adjusted for classical risk factors as assessed by IDI , but not by AUC .


Adipokines , biomarkers of inflammation and endothelial function were significantly associated to onset of type @ diabetes .


However their inclusion in predictive scores is not supported by the present study .


To our knowledge , no randomised study has compared rates of uncovered stent struts in everolimus ( EES ) vs. new-generation zotarolimus-eluting ( ZES-R ) stents in acute coronary syndrome ( ACS ) .


The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography ( OCT ) in ACS patients treated with drug-eluting stents ( DES ) comparing EES versus new-generation ZES-R .


All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised @:@ to EES or ZES-R .


The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography ( OCT ) at six months .


Secondary endpoints were the percentage of malapposed stent struts , percent neointimal hyperplasia cross-sectional area ( CSA ) and major adverse cardiac events ( MACE ) at six months .


A total of @ patients were randomised to EES ( n = @ ) or ZES-R ( n = @ ) .


No differences were observed in baseline characteristics between the two groups .


Overall , @ % presented with STEMI , of which @ % were anterior .


The other patients comprised @ % NSTEMI and @ % troponin-negative ACS .


A mean of @ lesions were treated per patient , with a mean of @ stents per lesion .


At @ days there was one sudden death .


Six-month OCT analysis was performed in @ lesions in the EES group and in @ lesions in the ZES-R group .


There was no difference in the primary endpoint of uncovered stent struts between groups ( EES @ % -LSB- @ , @ -RSB- vs. ZES-R @ % -LSB- @ , @ -RSB- ; p = @ ) .


Furthermore , there were no differences between groups in the percentage of malapposed stent struts , either with ( EES @ % -LSB- @ , @ -RSB- vs. ZES-R @ % -LSB- @ , @ -RSB- ; p = @ ) or without coverage ( EES @ % -LSB- @ , @ -RSB- vs. ZES-R @ % -LSB- @ , @ -RSB- ; p = @ ) .


Percent neointima CSA was similar in both groups ( EES @ % -LSB- @ , @ -RSB- vs. ZES-R @ % -LSB- @ , @ -RSB- ; p = @ ) .


At six-month clinical follow-up , no additional patients died or suffered MI .


There were four MACE in the EES group and one in the ZES-R group .


In our study , in patients presenting with ACS , both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis .


This prospective randomized pilot study reports our institutional experience and early results using Sonoma Wrx ( Sonoma Orthopedic Products , Santa Rosa , CA ) in the treatment of extra-articular and simple intra-articular distal radius fractures .


A total of @ patients , were enrolled in the study .


They were considered eligible if they had ; unstable extra-articular distal radius fractures and simple intra-articular distal radius fractures suitable for closed reduction ( AO types ; A@ @ , A@ @ , A@ @ C@ @ , C@ @ ) .


Patients in group I received intramedullary fixation using the Sonoma Wrx device and patients in group II received standard volar locking plate fixation .


Radiographic criteria of acceptable healing were used for evaluation .


Two groups were similar in terms of baseline characteristics .


Mean time of operation was significantly shorter in Group @ vs. in group @ ( @ vs. @ minutes , p = @ ) .


Time to healing of the fracture was not different between two groups ( @ vs. @ weeks for Group @ vs. @ , respectively p = @ ) .


Overall complications occurred in @ patients in group @ and in @ patients in group @ ( p = @ ) .


Follow-up was completed in all patients with a median time of @ months and @ months in group @ and @ , respectively .


On radiographic evaluation radial inclination , radial height and volar tilt were not significantly different between group @ and @ , respectively .


There were no significant differences between two groups in regard to wrist rotational degrees measured in last follow-up visit .


Sonoma Wrx Device is reliable and effective in terms of achieving satisfactory outcomes in treatment of distal radius fractures .


It may be reasonable to use this device to prevent complications that are related to extensive soft tissue dissection .


RAS is dysregulated in neurofibromatosis type @ ( NF@ ) related plexiform neurofibromas ( PNs ) .


The activity of tipifarnib , which blocks RAS signaling by inhibiting its farnesylation , was tested in children and young adults with NF@ and progressive PNs .


Patients aged @-@ years with NF@-related PNs and imaging evidence of tumor progression were randomized in a double-blinded fashion to receive tipifarnib ( @ mg/m ( @ ) orally every @ h ) or placebo ( phase A ) and crossed over to the opposite treatment arm at the time of tumor progression ( phase B ) .


PN volumes were measured with MRI , and progression was defined as @ % volume increase .


Time to progression ( TTP ) in phase A was the primary endpoint , and the trial was powered to detect whether tipifarnib doubled TTP compared with placebo .


Toxicity , response , and quality of life were also monitored .


Sixty-two patients were enrolled .


Tipifarnib and placebo were well tolerated .


On phase A , the median TTP was @ months on the placebo arm and @ months on the tipifarnib arm ( P = @ ; @-sided ) .


Quality of life improved significantly compared with baseline on the tipifarnib arm but not on the placebo arm .


Volumetric tumor measurement detected tumor progression earlier than conventional @-dimensional ( WHO ) and @-dimensional ( RECIST ) methods .


Tipifarnib was well tolerated but did not significantly prolong TTP of PNs compared with placebo .


The randomized , flexible crossover design and volumetric PN assessment provided a feasible and efficient means of assessing the efficacy of tipifarnib .


The placebo arm serves as an historical control group for phase @ single-arm trials directed at progressive PNs .


To determine whether a midwife-led intervention improved preparation for twin parenting and maternal psychosocial outcome .


Randomised controlled trial .


Two maternity units in North East England .


A cohort of @ women with uncomplicated twin pregnancy .


Self-completion questionnaire at multiple time points .


The primary outcome was probable postnatal depression ( measured with the Edinburgh Postnatal Depression Scale , EPDS ) @ weeks after delivery .


Secondary outcomes included preparation for parenting , maternal anxiety , parenting stress , and maternal wellbeing .


The mean maternal EPDS scores at @ weeks after delivery were @ ( SD @ ) in the twin intervention ( TI ) group and @ ( SD @ ) in the twin control ( TC ) group , and the mean difference between the groups was @ ( @ % confidence interval , @ % CI , -@ to @ ) .


The relative risk ( RR ) of having probable depression in the TI group compared with the TC group at @ weeks was @ ( @ % CI @-@ @ ) for mothers and @ ( @ % CI @-@ @ ) for fathers .


There were no statistically significant differences in maternal anxiety or parenting stress .


TI mothers reported increased maternal wellbeing , reaction to motherhood , family support , mood , and greater self-confidence @ weeks after delivery , and felt more prepared for parenting .


As a result of the limited sample size , the study was unable to detect a difference in maternal depression using the maternal EPDS mean score .


The antenatal preparation for parenting programme did not improve postnatal maternal anxiety or parenting stress ; however , it did improve postnatal maternal wellbeing , mood , self-confidence , reaction to motherhood , and better prepared mothers to parent twin infants .


Midwives have a key role in preparing mothers to parent twins .


Prior studies suggest that elevated markers of bone turnover are prognostic for poor survival in castration-resistant prostate cancer ( CRPC ) .


The predictive role of these markers relative to bone-targeted therapy is unknown .


We prospectively evaluated the prognostic and predictive value of bone biomarkers in sera from CRPC patients treated on a placebo-controlled phase III trial of docetaxel with or without the bone targeted endothelin-A receptor antagonist atrasentan ( SWOG S@ ) .


Markers for bone resorption ( N-telopeptide and pyridinoline ) and formation ( C-terminal collagen propeptide and bone alkaline phosphatase ) were assayed in pretreatment and serial sera .


Cox proportional hazards regression models were fit for overall survival .


Models were fit with main effects for marker levels and with/without terms for marker-treatment interaction , adjusted for clinical variables , to assess the prognostic and predictive value of atrasentan .


Analysis was adjusted for multiple comparisons .


Two-sided P values were calculated using the Wald test .


Sera from @ patients were analyzed .


Elevated baseline levels of each of the markers were associated with worse survival ( P < @ ) .


Increasing marker levels by week nine of therapy were also associated with subsequent poor survival ( P < @ ) .


Patients with the highest marker levels ( upper @th percentile for all markers ) not only had a poor prognosis ( hazard ratio -LSB- HR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ to @ ; P < @ ) but also had a survival benefit from atrasentan ( HR = @ ; @ % CI = @ to @ ; median survival = @ -LSB- atrasentan -RSB- vs @ months -LSB- placebo -RSB- ; P interaction = @ ) .


Serum bone metabolism markers have statistically significant independent prognostic value in CRPC .


Importantly , a small group of patients ( @ % ) with highly elevated markers of bone turnover appear to preferentially benefit from atrasentan therapy .


Limited data exist concerning outcomes of patients with non-ST-segment elevation acute coronary syndromes ( NSTE ACS ) with no angiographically obstructive coronary artery disease ( non-obstructive CAD ) .


We assessed the frequency of clinical outcomes among patients with non-obstructive CAD compared with obstructive CAD .


We pooled data from eight NSTE ACS randomized clinical trials from @ to @ , including @,@ patients who underwent coronary angiography .


The primary outcome was @-day death or myocardial infarction ( MI ) .


Adjusted odds ratios ( ORs ) and @ % confidence intervals ( CIs ) for @-day death or MI for non-obstructive versus obstructive CAD were generated for each trial .


Summary ORs ( @ % CIs ) across trials were generated using random effects models .


Overall , @ patients ( @ % ) had non-obstructive CAD .


They were younger , more were female , and fewer had diabetes mellitus , previous MI or prior percutaneous coronary intervention than patients with obstructive CAD .


Thirty-day death or MI was less frequent among patients with non-obstructive CAD ( @ % ) versus obstructive CAD ( @ % ) ( OR ( adj ) @ ; @ % CI , @-@ @ ) ; @-day death or spontaneous MI and six-month mortality were also less frequent among patients with non-obstructive CAD ( OR ( adj ) @ ( @-@ @ ) and @ ( @-@ @ ) , respectively ) .


Among patients with NSTE ACS , one in @ had non-obstructive CAD .


Death or MI occurred in @ % of these patients by @ days .


Compared with patients with obstructive CAD , the rate of major cardiac events was lower in patients with non-obstructive CAD but was not negligible , prompting the need to better understand management strategies for this group .


The week @ primary analysis of the ENCORE@ trial established the virological non-inferiority and safety of efavirenz @ mg compared with the standard @ mg dose , combined with tenofovir and emtricitabine , as first-line HIV therapy .


This @-week follow-up of the trial assesses the durability of efficacy and safety of this treatment over @ weeks .


ENCORE@ was a double-blind , placebo-controlled , non-inferiority trial done at @ clinical sites in @ countries .


HIV-infected adult patients ( @ years of age ) with no previous antiretroviral therapy , a CD@ cell count of @-@ cells per L , and plasma HIV-@ viral load of at least @ copies per mL were randomly assigned ( @:@ ) by an electronic case report form to receive fixed-dose daily tenofovir @ mg and emtricitabine @ mg plus efavirenz either @ mg daily or @ mg daily .


Participants , physicians , and all other trial staff were masked to treatment assignment .


Randomisation was stratified by HIV-@ viral load at baseline ( or > @ copies per mL ) .


The primary endpoint was the difference in the proportions of patients in the two treatment groups with a plasma HIV-@ viral load below @ copies per mL at week @ .


Treatment groups were deemed to be non-inferior if the lower limit of the @ % CI for the difference in viral load was above -@ % by modified intention-to-treat analysis .


Non-inferiority was assessed in the modified intention-to-treat , per-protocol , and non-completer = failure ( NC = F ) populations .


Adverse events and serious adverse events were summarised by treatment group .


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


Between Aug @ , @ , and March @ , @ , @ eligible participants were enrolled and randomly assigned to the two treatment groups ( @ to efavirenz @ mg and @ to efavirenz @ mg ) .


The intention-to-treat population who received at least one dose of study drug comprised @ patients : @ in the efavirenz @ mg group and @ in the efavirenz @ mg group .


@ patients ( @ % ; @ in the efavirenz @ mg group and @ in the @ mg group ) completed @ weeks of follow-up .


At @ weeks , @ ( @ % ) of @ patients in the efavirenz @ mg group and @ ( @ % ) of @ in the efavirenz @ mg group had a plasma HIV-@ viral load less than @ copies per mL ( difference -@ , @ % CI -@ to @ ; p = @ ) , which suggests continued non-inferiority of the lower efavirenz dose .


Non-inferiority was recorded for thresholds of less than @ and less than @ copies per mL , irrespective of baseline plasma viral load .


Adverse events were reported by @ ( @ % ) of @ patients in the efavirenz @ mg group and by @ ( @ % ) of @ in the @ mg group ( p = @ ) .


The proportions of patients reporting an adverse event that was definitely or probably related to efavirenz were @ ( @ % ) for efavirenz @ mg and @ ( @ % ) for efavirenz @ mg ( p = @ ) .


The number of patients who reported serious adverse events did not differ between the groups ( p = @ ) .


Our findings confirm that efavirenz @ mg is non-inferior to the standard dose of @ mg in combination with tenofovir and emtricitabine as initial HIV therapy over @ weeks .


Fewer efavirenz-related adverse events were reported with the @ mg efavirenz dose than with the @ mg dose .


These findings support the routine use of efavirenz @ mg .


The coadministration of rifampicin and efavirenz @ mg needs further investigation .


Overnight hypoglycemia occurs frequently in individuals with type @ diabetes and can result in loss of consciousness , seizure , or even death .


We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring ( CGM ) glucose levels .


Following an initial run-in phase , a @-night trial was conducted in @ individuals aged @-@ years with type @ diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active ( intervention night ) or inactive ( control night ) .


The primary outcome was the proportion of nights in which @ CGM glucose values @ mg/dL occurred .


Overnight hypoglycemia with at least one CGM value @ mg/dL occurred on @ of @ ( @ % ) intervention nights versus @ of @ ( @ % ) control nights ( odds ratio @ -LSB- @ % CI @-@ @ -RSB- ; P < @ ) .


Median hypoglycemia area under the curve was reduced by @ % , and hypoglycemia lasting > @ h was reduced by @ % .


Overnight sensor glucose was > @ mg/dL during @ % of control nights and @ % of intervention nights ( P = @ ) , while morning blood glucose was > @ mg/dL following @ % and @ % of nights , respectively ( P < @ ) , and > @ mg/dL following @ % and @ % , respectively .


Morning ketosis was present < @ % of the time in each arm .


Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis .


Male clients of female sex workers ( FSWs ) are at risk of HIV and other sexually transmitted infections ( STIs ) .


We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana , Mexico .


Male clients of FSWs who were at least @ , were HIV-negative at baseline , and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention , or a time-attention didactic control condition .


Each condition lasted approximately one hour .


Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline , and at @ , @ , and @month follow-ups .


Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes .


A total of @ participants were randomized to one of the two conditions .


Analyses indicated that randomization was successful ; there were no significant differences between the participants in the two conditions at baseline .


Average follow-up was @ % across both conditions .


This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial .


To determine the clinical performance of DAILIES TOTAL@ ( DT@ ) , Clariti @Day ( C@D ) , and @-DAY ACUVUE TruEye ( AVTE ) silicone hydrogel daily disposable contact lenses ( SiHy DDCLs ) .


Eligible participants , subdivided into asymptomatic and symptomatic groups , wore each SiHy DDCLs for three consecutive days .


Each participant attended three visits ( on day @ at @ hours ; on days @ and @ after @ hours of wear ) per lens type .


The order of lens wear was randomized , with at least @ day washout between lenses .


Lens-related performance was evaluated by assessing lens surface deposits , wettability , pre-lens noninvasive tear breakup time , lens movement , and centration ; ocular response assessments included conjunctival redness , corneal staining , and conjunctival staining and indentation .


Fifty-one asymptomatic and @ symptomatic participants completed the study .


For all visits , the mean noninvasive tear breakup time was about @ second longer with DT@ than with C@D and AVTE ( p < @ ) .


Overall , the wettability of all three lenses was good ; however , DT@ was graded marginally better than the other lenses ( both p < @ ) .


On day @ , eyes wearing AVTE had significantly more dehydration-induced corneal staining compared with DT@ ( AVTE , @ % ; DT@ , @ % ; p < @ ) .


After @ hours , conjunctival staining was different between lenses ( greatest with C@D and least with DT@ ; all p < @ ) .


Conjunctival indentation was more prevalent with the C@D lenses ( n = @ ) compared with DT@ ( n = @ ; p < @ ) and AVTE ( n = @ ; p < @ ) .


There were no differences between asymptomatic and symptomatic lens wearers for any of the clinical parameters ( all p > @ ) .


Each of the three SiHy DDCLs performed well .


Noninvasive tear breakup time was longest and wettability was greater with DT@ .


C@D had the most conjunctival staining conjunctival indentation .


There was no difference between asymptomatic and symptomatic wearers with regard to ocular response and contact lens-related parameters .


These results suggest that SiHy DDCLs may be an excellent contact lens modality for the symptomatic patient .


Hydrocarbons , especially kerosene ( paraffin ) , are the most common agents causing childhood poisoning in low and middle income countries ( LMICs ) .


Aspiration of kerosene causes an inflammatory sterile chemical pneumonitis , which may increase susceptibility to secondary lower respiratory tract bacterial infection .


This study aimed to assess the efficacy of prophylactic antibiotics in the management of kerosene-associated pneumonitis in children and to identify risk factors associated with severity or outcome .


A double-blind placebo-controlled trial of prophylactic antibiotics in the management of kerosene-associated pneumonitis of children presenting to a referral hospital was performed from July @ to September @ .


Sequential children with a history of kerosene ingestion and mild respiratory illness were randomised to receive placebo or amoxicillin .


Each child was followed-up at Day @ and Day @ post-ingestion .


The primary outcome measure was the number of treatment failures in each group , defined as any child who deteriorated within this time , necessitating a change in treatment regimen .


Secondary outcome measures were length of hospital stay and symptoms and signs at follow-up .


Seventy-four patients were enrolled .


Thirty-five ( @ % ) received placebo and @ ( @ % ) active treatment .


There was no significant difference in treatment failures between placebo ( @/@ , @ % ; @ % CI , @-@ ) and active ( @/@ , @ % ; @ % CI , @-@ ) groups ( relative risk , @ ; @ % CI , @-@ @ ) .


The median length of hospital stay was identical ( placebo @ days ; IQR , @-@ @ and active @ days ; IQR , @-@ @ ) .


Symptoms and signs at Days @ and @ post-ingestion were similar .


The only significant risk factor for treatment failure was residence in formal housing .


Clinical severity at presentation was similar for treatment successes and failures .


Prophylactic antibiotics do not improve the outcome in children with mild respiratory illness after kerosene ingestion .


To discuss the role of carbon nanoparticles in the protection of parathyroid during thyroid carcinoma surgery .


Seventy-two patients with thyroid carcinoma who had initial surgery were randomly divided into two groups : carbon nanoparticles group and the control group .


Emulsion of carbon nanoparticles was injected into the thyroid gland of carbon nanoparticles group patients .


After thirty minutes , the excision of thyroid carcinoma and VI group neck dissection were performed in carbon nanoparticles group patients , the control group directly underwent operation .


The black stained tissue in the dissection specimen of carbon nanoparticles group was separated .


The number of total lymph node , metastasis lymph node and parathyroid gland in the tissure black stained or not in two groups were counted respectively .


There were @ lymph nodes in the black stained tissue of central compartment dissection specimen of carbon nanoparticles group .


No parathyroid gland was found in the black stained tissue .


Fifteen lymph nodes containing four parathyroid glands were found in the non black stained tissue in carbon nanoparticles group while there were @ lymph nodes containing @ parathyroid glands in the control group .


There were statistical difference between the amount of lymph node in black stain tissue and the specimen of the control group .


Parathyroid glands were not stained black , and no parathyroid gland was found in the black-stained tissue .


The carbon nanoparticles could be used to identify the lymph node and the parathyroid gland for protecting the parathyroid gland in thyroid surgery .


Chronic urticaria not responsive to antihistamines is a difficult disease to manage .


Methotrexate has been used in difficult chronic urticarias with some benefit .


To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H@ antihistaminics .


In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre , @ patients with chronic spontaneous urticaria not responding well to H@ antihistaminics were recruited .


Patients were randomly allocated to receive either a weekly dose of oral methotrexate @ mg or placebo ( calcium carbonate ) for a total duration of @ weeks , after which treatment was stopped and patients were followed up for relapse of urticaria .


Each group also received levocetrizine @ mg once daily for symptom control .


Primary outcome measured was a reduction by > @/@ rd of baseline urticaria scores after @ week therapy .


Secondary outcome was a reduction in antihistamine requirement after stopping therapy .


Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group .


Out of @ patients who completed therapy , the primary outcome was achieved by @ @ ( out of @ ) patients in the methotrexate group and by @ @ ( out of @ ) patients in the placebo group ( P > @ ) .


Ten patients followed up , after stopping therapy , for a mean period of @ @ months ; @ remained in remission and @ had relapsed .


One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study .


The placebo group did not experience any side effects .


Methotrexate @ mg weekly for @ months did not provide any additional benefit over H@ antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility .


Postoperative continuous positive airway pressure ( CPAP ) can improve lung function .


The aim of our study was to assess the efficacy of prophylactic CPAP on the Pa ( O@ ) / FI ( O@ ) ratio measured the day after surgery in patients undergoing lung resection surgery ( LRS ) .


The study population comprised @ patients undergoing LRS .


On arrival in the postanaesthesia care unit ( PACU ) , patients were randomized to receive CPAP at @-@ cm H@O during the first @ h after surgery ( CPAP group ) or supplemental oxygen through a Venturi mask ( Venturi group ) .


The Pa ( O@ ) / FI ( O@ ) ratio was measured on arrival in the PACU , @ h after admission , and the day after surgery .


The Pa ( O@ ) / FI ( O@ ) ratio is the primary endpoint of our study .


We also analysed the chest radiograph and assessed the postoperative course .


We then analysed the impact of ventilatory management in the PACU depending on the respiratory risk of the patient .


Baseline characteristics were similar in both groups .


Patients who received CPAP had significantly higher Pa ( O@ ) / FI ( O@ ) at @ h after surgery compared with patients managed conventionally ( Venturi group ) ( @ vs @ , P = @ ) , but there were no differences at @ h. On subgroup analysis , we found that the benefits of CPAP were greater in higher risk patients .


The incidence of postoperative pulmonary complications and stay in the PACU and hospital were similar in both groups .


In patients undergoing LRS , prophylactic CPAP during the first @ h after surgery with a pressure of @-@ cm H@O improved the Pa ( O@ ) / FI ( O@ ) ratio at @ h.


This effect was more evident in patients with increased risk of postoperative pulmonary complications .


Maternal obesity and gestational weight gain are linked to offspring adverse metabolic profiles , and lifestyle interventions during pregnancy in obese women may have long-term positive effects on their children .


Furthermore , although the association between birth weight and later metabolic outcomes is well established , little is known about the predictive value of abdominal circumference at birth .


The purpose of this study was to determine ( @ ) the effects of lifestyle interventions during pregnancy in obese women on offspring metabolic risk factors and ( @ ) predictive values of birth weight ( BW ) and birth abdominal circumference ( BAC ) .


This was a follow-up of a randomized controlled trial , the Lifestyle in Pregnancy ( LiP ) study .


The study was conducted in Odense and Aarhus University Hospitals , Denmark .


We studied the offspring of LiP study participants ( n = @ ) and offspring of normal-weight mothers ( external reference group , n = @ ) .


INTERVENTIONs included dietary advice , coaching , and exercise during pregnancy .


The outcome measures were body mass index ( BMI ) Z-score , abdominal circumference , blood pressure , and fasting plasma glucose , insulin , high-density lipoprotein , and triglycerides at the age of @ years .


No differences were detected in BMI Z-scores or metabolic risk factors between the LiP intervention and control groups or between the LiP and external reference groups .


BAC and BW were associated ( all P < @ ) with BMI Z-score ( @-@ @ ) , abdominal circumference ( @-@ @ ) , plasma glucose ( @-@ @ ) , insulin ( @-@ @ ) , and triglycerides ( @-@ @ ) but not with blood pressure or high-density lipoprotein ( regression coefficients per increase in BAC and BW of @ SD score ) .


Early childhood metabolic risk factors were unaffected by lifestyle interventions in obese pregnant women .


Offspring of obese mothers who participated in the LiP study were comparable to offspring of normal-weight mothers , possibly indicating a general beneficial effect of trial participation .


BAC and BW were both associated with later metabolic risk factors .


Colorectal cancer screening ( CRCS ) reduces morbidity and mortality ; however , the positive benefits might be partially offset by long-term distress following positive screening results .


We examined relationships among colorectal cancer-specific worry and situational anxiety after positive fecal occult blood tests -LSB- FOBT ( + ) -RSB- compared with receipt of negative results .


Of note , @,@ eligible members of Group Health , an integrated healthcare delivery system , completed baseline surveys and received FOBT screening kits , with @,@ members returning the kits .


We matched FOBT ( + ) patients ( n = @ ) @:@ on age and sex with FOBT ( - ) respondents ( n = @ ) .


Both groups completed follow-up surveys at @ to @ days and @ months after screening .


We assessed situational anxiety ( State-Trait Anxiety Inventory , STAI ) , colorectal cancer worry frequency , and mood disturbance .


Mean age was @ years , and majority were women ( @ % ) and White ( @ % ) .


After adjusting for age , sex , and baseline worry , at @ to @ days after screening , the FOBT ( + ) group was @ -LSB- @ % confidence interval ( CI ) , @-@ @ -RSB- times more likely to report colorectal cancer-related mood disturbances and significantly higher mean STAI scores than the FOBT ( - ) group ( mean = @ vs. @ ; P = @ ) .


At @-month posttest , mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT ( + ) .


No colon cancer worry frequency was observed .


FOBT ( + ) results are associated with short-term situational anxiety and colorectal cancer-specific mood disturbances .


Distress from FOBT ( + ) results declined to near-baseline levels by @ months .


Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy .


The purpose of this study was to assess the anti-inflammatory , analgesic and osteogenic early effects of melatonin on post-extraction sockets of patients requiring third molars extraction .


A randomized , triple-blind clinical trial was made using a split-mouth design .


Both lower third molars of @ patients were extracted and @ mg of local melatonin or placebo were applied .


Concentrations of interleukin-@ and nitrotyrosine were determined on samples of the clot from the socket by independent ELISA tests .


Radiographic bone density was evaluated by measuring Hounsfield Units in panoramic and cross sections obtained by digital scanner .


Statistical analysis by Kolmogorov-Smirnov test was performed for ELISA data .


Bone density was analyzed by Shapiro-Wilk test .


Subsequently t test was applied .


P < @ was considered to be significant .


The concentration of interleukin-@ increased with the application of melatonin without statistically significance ( @ @ pg/ml vs @ @ pg/ml ) .


Nitrotyrosine concentrations showed values below to the detectability pattern ( < @ nM ) in Optic Density curve .


Bone density in panoramic sections at socket after melatonin application showed no significant difference ( @ @ HU vs @ @ HU ) .


In cross sections , bone density in the alveolar region showed no significant difference ( @ @ HU vs @ @ HU ) .


Within the limitations of this pilot study , no differences with the application of melatonin were found in terms of the concentration of interleukin-@ and bone density in post-extraction socket of retained mandibular third molars .


There is consistent evidence that the binge drinking standard of @ + drinks per drinking occasion for men ( @ + for women ) is associated with risk for negative consequences .


Yet , many have questioned the adequacy of this measure as an index of intoxication ( e.g. , a blood alcohol concentration -LSB- BAC -RSB- of @ g % ) .


In response to these concerns , a National Institute on Alcohol Abuse and Alcoholism task force recommended adding a time qualifier of @hours to this criterion .


Although conceptually appealing , there has been little effort to determine whether this new measure better captures drinking that leads to negative consequences .


This study examined the new binge standard ( @-hour period ) and old binge standard ( no time qualifier ) in relation to frequency of drinking to an estimated BAC of @ g % and the experience of negative drinking consequences .


These relations were examined within both a social drinking sample of adults ( N = @ ) and a sample of heavy-drinking young adults ( N = @ ) participating in a randomized clinical trial for drinking reduction .


Contrary to the purpose of adding a time qualifier , the new binge measure was not more strongly correlated with drinking to an estimated BAC of @ g % relative to the old binge measure .


In addition , when both measures were entered simultaneously into a regression model , only the old binge measure accounted for significant variance in negative drinking consequences .


These empirically based results suggest that the original binge standard without a time qualifier may be preferable to the @-hour standard as a marker for risk .


The findings also suggest that further efforts are needed to identify a brief measure that effectively captures drinking to intoxication and related risk for negative consequences .


Green tea ( GT ) is able to increase energy expenditure ( EE ) and fat oxidation ( FATox ) via inhibition of catechol-O-methyl transferase ( COMT ) by catechins .


However , this does not always appear unanimously because of large inter-individual variability .


This may be explained by different alleles of the functional COMT Val@/@Met polymorphism that are associated with COMT enzyme activity ; high-activity enzyme , COMT ( H ) ( Val/Val genotype ) , and low-activity COMT ( L ) ( Met/Met genotype ) .


Fourteen Caucasian subjects ( BMI : @ kg/m@ , age : @ years ) of whom @ with the COMT ( H ) - genotype and @ with the COMT ( L ) - genotype were included in a randomized , cross-over study in which EE and substrate oxidation were measured with a ventilated-hood system after decaffeinated GT and placebo ( PL ) consumption .


At baseline , EE , RQ , FATox and carbohydrate oxidation ( CHOox ) did not differ between groups .


Significant interactions were observed between COMT genotypes and treatment for RQ , FATox and CHOox ( p < @ ) .


After GT vs. PL , EE ( GT : @ vs. PL : @ kJ @ hrs ; p < @ ) , RQ ( GT : @ vs. PL : @ ; p < @ ) , FATox ( GT : @ vs. PL : @ g/d ; p < @ ) and CHOox ( GT : @ vs. PL : @ g/d ; p < @ ) were significantly different for subjects carrying the COMT ( H ) genotype , but not for subjects carrying the COMT ( L ) genotype ( EE , GT : @ vs. PL : @ kJ @ hrs ; NS ) , ( RQ , GT : @ vs. PL : @ ; NS ) , ( FATox , GT : @ vs. PL : @ g/d ; NS ) , ( CHOox , GT : @ vs. PL : @ g/d ; NS ) .


Subjects carrying the COMT ( H ) genotype increased energy expenditure and fat-oxidation upon ingestion of green tea catechins vs , placebo , whereas COMT ( L ) genotype carriers reacted similarly to GT and PL ingestion .


The differences in responses were due to the different responses on PL ingestion , but similar responses to GT ingestion , pointing to different mechanisms .


The different alleles of the functional COMT Val@/@Met polymorphism appear to play a role in the inter-individual variability for EE and FATox after GT treatment .


Caudal analgesia has been prolonged by the addition of various adjuvants .


Dexmedetomidine is a highly selective alpha-@ agonist with sedative and analgesic properties .


To investigate the effect of addition of dexmedetomidine to @ % bupivacaine for caudal analgesia in children undergoing major abdominal cancer surgery .


A randomized double-blind trial .


Academic medical center .


Forty pediatric patients , aged @ - @ years , weighting @ - @ kg , and of American Society of Anesthesiologists ( ASA ) physical status I and II scheduled for major abdominal cancer surgeries under general anesthesia combined with caudal analgesia were enrolled .


They were randomly allocated into @ groups : Group I ( BD ) : ( n = @ ) received @ mL/kg bupivacaine @ % with dexmedetomidine @ g/kg and group II ( B ) : ( n = @ ) received @ mL/kg bupivacaine @ % .


Heart rate ( HR ) , mean arterial pressure ( MAP ) , and oxygen saturation ( SPO@ ) were recorded for @ minutes .


Pain was assessed immediately postoperative and at hours @ , @ , @ , @ , @ , and @ of postoperative period by Face , Legs , Activity , Cry and Consolability ( FLACC ) score .


Time to first request for analgesia and total analgesic consumption in the first @ hours were recorded .


The level of sedation was recorded using Ramsay 's sedation scale -LSB- Intravenous acetaminophen @mg/kg ( perfalgan , Squibb ) -RSB- .


Adverse effects were recorded and treated .


There was significant reduction in FLACC score in group BD at @ , @ , @ , and @ hours postoperatively compared to group B.


At the eighteenth and twenty-fourth hour there was no significant difference .


Time of the first rescue analgesic requirement was significantly prolonged in group BD compared to group B.


The mean total consumption of rescue analgesia in the @ hours of the postoperative period was significantly decreased in group BD ( @ @ ) mg when compared with group B ( @ @ ) mg .


This study is limited by its small sample size .


Addition of dexmedetomidine ( @ g/kg ) to caudal bupivacaine @ % ( @ mL/kg ) in pediatric major abdominal cancer surgeries achieved significant postoperative pain relief for up to @ hours , with less use of postoperative analgesics , and prolonged duration of arousable sedation .


Hemodynamic changes were statistically significant , yet of no clinical significance .


To develop a mapping algorithm for estimating EuroQol five-dimensional ( EQ-@D ) questionnaire values from the prostate cancer-specific health-related quality-of-life ( HRQOL ) instrument Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) instrument .


The EQ-@D questionnaire and FACT-P instrument data were collected for a subset of patients with metastatic castration-resistant prostate cancer in a multicenter , randomized , double-blind , placebo-controlled phase @ trial .


We compared three statistical techniques to estimate patients ' EQ-@D questionnaire index scores determined by using the UK tariff : @ ) generalized estimating equations , @ ) two-part model combining logistic regression and generalized estimating equation , and @ ) separate mapping algorithms for patients with poor health defined as a FACT-P score of @ or less ( group-specific model ) .


Four different sets of explanatory variables were compared .


The models were cross-validated by using a @-fold in-sample cross-validation .


Values for both instruments were available for @ patients with metastatic castration-resistant prostate cancer .


The group-specific model including the FACT-P subscale scores and baseline variables had the best predictive performance with R ( @ ) @ , root mean square error @ , and mean absolute error @ .


The two-part model and the generalized estimating equation model including the FACT-P subdomain scores and baseline variables also had good predictive performance .


The developed algorithms for mapping the FACT-P instrument to the EQ-@D questionnaire enable the estimation of preference-based health-related quality-of-life scores for use in cost-effectiveness analyses when directly elicited EQ-@D questionnaire data are missing .


Very-low-birth-weight ( VLBW ) infants are dependent on parenteral nutrition after birth .


A parenteral lipid emulsion with a multicomponent composition may improve growth and neurodevelopment and may prevent liver injury , which is often observed in association with long-term parenteral nutrition with pure soybean oil .


Our aim was to evaluate the safety and efficacy of a multicomponent lipid emulsion containing @ % soybean oil , @ % medium-chain triacylglycerol , @ % olive oil , and @ % fish oil compared with a conventional pure soybean oil emulsion in VLBW infants .


We conducted a double-blind randomized controlled trial in VLBW infants randomized to parenteral nutrition with the multicomponent ( study group ) or pure soybean oil emulsion ( control group ) from birth at a dose of @ to @ g kg ( -@ ) day ( -@ ) until the infants were receiving full enteral nutrition .


We assessed efficacy by growth rates and measuring plasma fatty acid profiles ( representative subset ) .


Safety was evaluated by assessing hematologic and biochemical parameters , potentially harmful phytosterol concentrations ( same subset ) , and clinical neonatal outcome parameters .


Ninety-six infants were included ( subsets n = @ ) .


The multicomponent emulsion was associated with higher weight and head circumference z scores during admission .


Plasma eicosapentaenoic acid and docosahexaenoic acid concentrations were higher in the study group .


The hematological , biochemical , and neonatal outcomes were not different between groups , whereas the plasma concentrations of phytosterols were higher in the control group .


The multicomponent lipid emulsion was well tolerated and associated with improved growth and higher plasma fatty acid profiles in VLBW infants in comparison with the pure soybean oil emulsion .


Recently , intense pulsed light ( IPL ) and low-fluence Q-switched neodymium-doped yttrium aluminum ( LF-QS-Nd : YAG ) laser have been successfully used to treat melasma .


To evaluate the effectiveness and safety of combined novel fractionated IPL ( IPL-F ) with LF-QS-Nd : YAG laser in patients with melasma .


Twelve patients underwent @ treatment sessions of concomitant IPL-F and LF-QS-Nd : YAG laser ( combination group ) , and @ patients underwent @ treatment session of IPL-F alone ( IPL only group ) .


Partial melasma area and severity index ( MASI ) scores were evaluated by @ dermatologists using digital photography .


In the combination group , the partial MASI score has significantly decreased by @ % at @ month after the treatment ( p < @ ) and @ % at @ months after the last treatment ( p < @ ) .


At @ month and @ months after the treatment , the decrease in the partial MASI score of the combination group was significantly larger than that of the IPL only group ( p < @ ) .


In both groups , treatment with IPL-F and LF-QS-Nd : YAG laser was well tolerated .


Our results suggest that the combination of the IPL-F with LF-QS-Nd : YAG laser may be an effective and safe modality for melasma patients .


Although serrated polyps may be precursors of colorectal cancer ( CRC ) , prospective data on the long-term CRC risk in individuals with serrated polyps are lacking .


In a population-based randomised trial , @,@ individuals aged @-@years were screened with flexible sigmoidoscopy , while @ individuals comprised the control arm .


We used Cox models to estimate HRs with @ % CIs for CRC among individuals with @ large serrated polyp ( @mm in diameter ) , compared with individuals with adenomas at screening , and to population controls , and multivariate logistic regression to assess polyp risk factors for CRC .


A total of @ individuals had large serrated polyps , of which @ were included in the analyses .


Non-advanced adenomas were found in @ individuals , advanced adenomas in @ .


Median follow-up was @ years .


Compared with the control arm , the HR for CRC was @ ( @ % CI @ to @ ) in individuals with large serrated polyps , @ ( @ % CI @ to @ ) in individuals with advanced adenomas and @ ( @ % CI @ to @ ) in individuals with non-advanced adenomas .


A large serrated polyp was an independent risk factor for CRC , adjusted for histology , size and multiplicity of concomitant adenomas ( OR @ ; @ % CI @ to @ ) .


Twenty-three large serrated polyps found at screening were left in situ for a median of @ years .


None developed into a malignant tumour .


Individuals with large serrated polyps have an increased risk of CRC , comparable with individuals with advanced adenomas .


However , this risk may not be related to malignant growth of the serrated polyp .


Nonalcoholic fatty liver disease ( NAFLD ) is characterized by high intrahepatic triglyceride level .


It is associated with an increased prevalence of cardiovascular disease , independently of underlying cardiometabolic risk factors .


Metformin is used as a pharmacological treatment ; the adherence is low because of the presence of adverse effects .


Aerobic exercise could be an alternative therapy , but its effectiveness compared with metformin has not been established in the treatment of NAFLD .


The aim of this study was to establish the effectiveness of aerobic exercise and its influence in reducing cardiovascular risk in overweight or obese women with NAFLD .


Sedentary women @-@ years old with body mass index ( BMI ) > @ kg/m@ and liver fat content < @ HU , were randomly divided into two parallel groups : exercise group ( EG ) or metformin group ( MG ) .


The EG performed an aerobic exercise program of @ min/@ days / week at @-@ % of heart rate reserve ; the MG took @ g/day of metformin each morning .


The duration of the intervention was @ weeks .


The liver fat content , metabolic and cardiorespiratory - fitness parameters were evaluated at the beginning and end of the program .


The study complied with the Helsinki ethics codes for human research .


The study included a sample of @ women , with @ per group .


The treatments modified the liver fat content by @ % ( CI@ % @ , @ ) and @ % ( CI@ % -@ , @ ) for the EG and MG , respectively .


In the EG , the insulin levels and HOMA-IR decreased ( P < @ ) , and the cardiovascular fitness improved .


An aerobic exercise program of @ weeks with a volume training of @ min/week and a moderate to vigorous intensity ( @-@ % VO@peak ) modified the liver fat content and improved cardiovascular risk factors during the intervention .


Exercise contributed to a holistic approach by modifying a number of the components of metabolic syndrome , cardiorespiratory-fitness , and cardiovascular risk .


Brief interventions via the internet have been shown to reduce university students ' alcohol intake .


This study tested two smartphone applications ( apps ) targeting drinking choices on party occasions , with the goal of reducing problematic alcohol intake among Swedish university students .


Students were recruited via e-mails sent to student union members at two universities .


Those who gave informed consent , had a smartphone , and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test ( AUDIT ) were randomized into three groups .


Group @ had access to the Swedish government alcohol monopoly 's app , Promillekoll , offering real-time estimated blood alcohol concentration ( eBAC ) calculation ; Group @ had access to a web-based app , PartyPlanner , developed by the research group , offering real-time eBAC calculation with planning and follow-up functions ; and Group @ participants were controls .


Follow-up was conducted at @weeks .


Among @ students offered participation , @ agreed to join ; @ were excluded due to incomplete data , and @ fulfilled eligibility criteria for randomization .


Attrition was @-@ @ percent , higher among heavier drinkers and highest in Group @ .


Self-reported app use was higher in Group @ ( @ % ) compared to Group @ ( @ % ) .


Per-protocol analyses revealed only one significant time-by-group interaction , where Group @ participants increased the frequency of their drinking occasions compared to controls ( p = @ ) .


Secondary analyses by gender showed a significant difference among men in Group @ for frequency of drinking occasions per week ( p = @ ) , but not among women .


Among all participants , @ percent showed high-risk drinking , over the recommended weekly drinking levels of @ ( women ) and @ ( men ) standard glasses .


Smartphone apps can make brief interventions available to large numbers of university students .


The apps studied using eBAC calculation did not , however , seem to affect alcohol consumption among university students and one app may have led to a negative effect among men .


Future research should : @ ) explore ways to increase user retention , @ ) include apps facilitating technical manipulation for evaluation of added components , @ ) explore the effects of adapting app content to possible gender differences , and @ ) offer additional interventions to high-risk users .


Evogliptin ( DA-@ ) is a novel , potent , and selective dipeptidyl peptidase IV ( DPP-IV ) inhibitor in clinical development for the treatment of type @ diabetes mellitus .


This study aimed to investigate the pharmacokinetic and pharmacodynamic profiles and tolerability of evogliptin after repeated oral administration in healthy subjects .


A block-randomized , double-blind , placebo-controlled , multiple-dose , dose-escalation study was performed in a total of @ subjects .


Repeated once-daily doses of @ , @ , or @ mg evogliptin or the same doses of placebo were orally administered to ten subjects in each dosage group for @ days .


Subjects in each group were randomized to receive evogliptin or placebo with a ratio of @:@ .


Pharmacokinetics of evogliptin were evaluated , with its concentrations in serial plasma and urine samples collected following the first and last administrations .


DPP-IV activity and glucagon-like peptide-@ , glucose , and insulin levels were quantified to evaluate evogliptin 's pharmacodynamics on the first and last dosing days .


All participants completed the study without any serious or severe adverse event .


The evogliptin plasma concentration reached its peak within @-@ hours and decreased relatively slowly , with a terminal elimination half-life of @-@ hours .


Repeated administration resulted in a @ - to @-fold accumulation .


Evogliptin 's systemic exposure and inhibition of plasma DPP-IV activity increased in a dose-dependent manner .


Inhibition of DPP-IV activity > @ % was sustained over @ hours in all evogliptin dose groups and provided an increase in postprandial active glucagon-like peptide-@ levels by @ - to @-fold .


Postprandial glucose levels in the evogliptin-treated groups were reduced @ % -@ % compared to placebo , but were not accompanied by increased insulin levels .


Repeated administration of evogliptin in healthy subjects was well tolerated and exhibited linear pharmacokinetics within the @-@ mg dose range .


A once-daily regimen of @-@ mg evogliptin effectively inhibited DPP-IV activity .


Taurine 's role in bile acid metabolism and anti-inflammatory activity could exert a protective effect on hepatobiliary complications associated with parenteral nutrition ( PN ) .


In this study , the effects of @ amino acid solutions , with and without taurine , on liver function administered to nonacutely ill postsurgical patients as part of a short-term PN regimen were prospectively compared .


Adult patients randomly received ( double-blind ) Tauramin @ % or a standard PN solution without taurine as the control ( @ g amino acid/kg body weight -LSB- bw -RSB- / d ; infusion rate of @ mg glucose/kg bw/d ) for a period of @-@ days .


- Glutamyl transpeptidase ( GGT ) and other indicators of liver function , glucose metabolism , lipid profile , inflammation markers , and treatment safety data were collected .


Thirty-five patients receiving taurine PN and @ receiving control PN were enrolled ( intention-to-treat -LSB- ITT -RSB- population ) .


Most patients ( n = @ ) discontinued after day @ of follow-up ( per-protocol -LSB- PP -RSB- population : n = @ and n = @ , respectively ) .


ITT patients with high GGT values after @ days of PN comprised @ % and @ % , respectively .


The mean change in GGT values with respect to the baseline values was @ @ and @ @ IU/L , respectively .


Low-density lipoprotein ( LDL ) cholesterol levels after @ days of PN were significantly decreased in the taurine PN group of PP patients ( -@ @ vs @ @ mg/dL for control PN ; P < @ ) .


None of the adverse events reported ( taurine PN : n = @ ; control PN : n = @ ) were treatment related .


PN solutions with and without taurine had similar effects on liver function parameters , except for an LDL reduction in PN with taurine , when administered to nonacutely ill postsurgical patients in the short term ( @-@ days ) .


Deep brain stimulation ( DBS ) improves motor symptoms in Parkinson 's disease ( PD ) , but questions remain regarding neuropsychological decrements sometimes associated with this treatment , including rates of statistically and clinically meaningful change , and whether there are differences in outcome related to surgical target .


Neuropsychological functioning was assessed in patients with Parkinson 's disease ( PD ) at baseline and after @ months in a prospective , randomised , controlled study comparing best medical therapy ( BMT , n = @ ) and bilateral deep brain stimulation ( DBS , n = @ ) at either the subthalamic nucleus ( STN , n = @ ) or globus pallidus interna ( GPi , n = @ ) , using standardised neuropsychological tests .


Measures of functional outcomes were also administered .


Comparison of the two DBS targets revealed few significant group differences .


STN DBS was associated with greater mean reductions on some measures of processing speed , only one of which was statistically significant in comparison with stimulation of GPi .


GPi DBS was associated with lower mean performance on one measure of learning and memory that requires mental control and cognitive flexibility .


Compared to the group receiving BMT , the combined DBS group had significantly greater mean reductions at @-month follow-up in performance on multiple measures of processing speed and working memory .


After calculating thresholds for statistically reliable change from data obtained from the BMT group , the combined DBS group also displayed higher rates of decline in neuropsychological test performance .


Among study completers , @ ( @ % ) study participants receiving DBS displayed reliable decline by multiple indicators in two or more cognitive domains , a significantly higher rate than in the BMT group ( @ % ) .


This multi-domain cognitive decline was associated with less beneficial change in subjective ratings of everyday functioning and quality of life ( QOL ) .


The multi-domain cognitive decline group continued to function at a lower level at @-month follow-up .


In those with PD , the likelihood of significant decline in neuropsychological functioning increases with DBS , affecting a small minority of patients who also appear to respond less optimally to DBS by other indicators of QOL .


Posttraumatic stress disorder ( PTSD ) and alcoholism are frequently comorbid , suggesting the possibility of overlapping neural substrates .


The neurokinin @ ( NK@ ) receptor for substance P ( SP ) has been implicated in both stress - and alcohol-related behaviors .


The NK@ antagonist aprepitant , clinically available as a treatment for chemotherapy-induced nausea , offers a tool to probe a potential role of the SP/NK@ system in comorbid PTSD and alcoholism .


The aim of this study is to evaluate the efficacy of aprepitant for treatment of comorbid PTSD and alcoholism .


Fifty-three patients with PTSD and alcoholism were admitted for @ weeks to an inpatient unit at the NIH Clinical Center and randomized to double-blind aprepitant ( @ mg/day ; based on PET studies reporting > @ % central receptor occupancy at this dose ) or placebo .


After reaching steady state , subjects were assessed for PTSD symptom severity , behavioral and neuroendocrine responses to stress and alcohol cues , and functional magnetic resonance imaging ( fMRI ) responses to stimuli with positive or negative emotional valence .


Aprepitant treatment had no effect on PTSD symptoms or subjective or physiological responses to stress or alcohol cues .


However , aprepitant robustly potentiated ventromedial prefrontal cortex ( mPFC ) fMRI responses to aversive visual stimuli .


Despite the lack of effect on PTSD symptoms and responses to stress/alcohol cues , NK@ antagonism activated the ventral mPFC , an area considered hypoactive in PTSD , during exposure to aversive stimuli .


Because this brain area is critically important for extinction of fear memories and in alcohol craving and relapse , our finding suggests that NK@ antagonism might be a useful pharmacological treatment to enhance extinction-based cue-exposure therapies .


The purpose of this study is to investigate the impact of cognitive group therapy and happiness training objectively in the local cerebral blood flow of patients with major depression ( MD ) .


The present research is semi-experimental to pre - and post-test with a control group .


Three groups were formed , and this number was incorporated in each group : @ patients were chosen randomly ; the first group of depressed patients benefited from the combination of pharmacotherapy and sessions of cognitive group therapy ; the second group used a combination of pharmacotherapy and sessions of happiness training ; and a third group used only pharmacotherapy .


We compared cognitive-behavioural therapy and happiness training efficacy with only pharmacotherapy in MD patients .


We performed brain perfusion SPECT in each group , before and after each trial .


The study was conducted on @ patients with MD ( @ women and @ men ; mean age : @ @ ; range : @-@ years ) .


There were significant differences regarding the two trial effects into two experimental groups ( p < @/@ ) before and after trials , while such differences were not significant in the control group ( p > @ ) .


In addition , there was significant difference among the regional cerebral blood flow in the frontal and prefrontal regions into two experimental groups before and after trials ( p < @/@ ) , while such differences were not significant in the control group ( p > @ ) .


This study demonstrated decreased cerebral perfusion in the frontal regions in MD patients , which increased following cognitive group therapy and happiness training .


Because of its availability , low costs , easy performance , and the objective semi-quantitative information supplied , brain perfusion SPECT scanning might be useful to assess the diagnosis and therapy efficacy .


Further exploration is needed to validate its clinical role .


In cases of exacerbation or crisis , myasthenia gravis ( MG ) patients can be treated with intravenous immunoglobulin ( IVIg ) , plasmapheresis , or immunoadsorption .


However , IVIg efficacy data in maintenance treatment are sparse .


We prospectively observed @ index patients with chronic and insufficiently controlled MG under standard immunosuppressant therapy and symptomatic treatment .


The IVIg treatment response was measured using changes in quantitative myasthenia gravis ( QMG ) score and surrogates .


Based on these results , a sample size calculation for a future randomized , controlled trial ( RCT ) was simulated .


There was an enduring decline in QMG score and other parameters of about @ % under IVIg maintenance treatment .


RCT sample size calculation results in @ or @ patients per arm to detect at least a @ % vs. @ % clinical difference in QMG score .


We recommend using the QMG score as a primary endpoint for an RCT of IVIg maintenance for chronic MG .


To evaluate the safety and efficacy of osmotic-controlled release oral delivery system ( OROS ) methylphenidate ( MPH ) HCl in adults with attention-deficit/hyperactivity disorder ( ADHD ) .


In this study , @ adults with ADHD were randomized to OROS MPH or placebo .


During the @-week titration period , patients were titrated from a starting dose of @ mg once daily to an individually-optimized dose of up to @ mg once daily in weekly @-mg increments .


Patients continued on their individualized dose during the @-week efficacy assessment period .


The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners ' Adult ADHD Rating Scale-Observer : Screening Version ( CAARS-O : SV ) from baseline to endpoint .


The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O : SV was significantly larger with OROS MPH compared with placebo ( P < @ , ANCOVA ) .


Similar results were observed for the majority of secondary endpoints , including CAARS-O : SV total score and other subscale scores .


Although treatment-emergent adverse events were reported more frequently in the OROS MPH group ( @ % ) versus the placebo group ( @ % ) , OROS-MPH showed a well-tolerated safety profile overall .


OROS MPH in a dose range of @-@ mg once daily was effective and well-tolerated in adult patients with ADHD .


In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction , ischemic postconditioning has been shown to reduce infarct size , but the effect on clinical outcome has not been tested in a large randomized trial .


In addition , deferring stent implantation in the infarct-related lesion @ to @ days after acute opening of the infarct-related artery could have protective effects , by reducing the risk of injury caused by distal embolization and microvascular obstruction .


Finally , a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery .


Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain .


The DANAMI @ trial program was designed to investigate @ different randomized treatment strategies in patients with ST-segment elevation myocardial infarction : ( @ ) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure ; ( @ ) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death , hospitalization for heart failure , reinfarction , and repeat revascularization ; and ( @ ) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease , with a primary end point of death , reinfarction , and repeat revascularization .


The DANAMI @ trial program will determine whether either of @ approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization .


We aimed to investigate whether thrombus aspiration could preserve the index of microcirculatory resistance ( IMR ) after primary percutaneous coronary intervention ( PCI ) in patients with ST-elevation myocardial infarction ( STEMI ) .


Sixty-three patients with STEMI were randomised into two groups : primary PCI after thrombus aspiration ( aspiration group , n = @ ) and primary PCI without thrombus aspiration ( non-aspiration group , n = @ ) .


IMR was measured using a pressure-temperature sensor-tipped coronary wire .


Echocardiography was performed at baseline and at six-month follow-up .


No significant differences in baseline ejection fraction ( EF , @ % vs. @ % , p = @ ) and baseline wall motion score index ( WMSI , @ vs. @ , p = @ ) were observed between the two groups .


However , significant differences in IMR ( @ U vs. @ U , p = @ ) , % E@ % @ % @EF ( follow-up EF - baseline EF ; @ % vs. @ % , p = @ ) , and % E@ % @ % @WMSI ( follow-up WMSI - baseline WMSI ; -@ vs. -@ , p = @ ) were observed between the two groups .


Thrombus aspiration as an adjunctive method to primary PCI for STEMI may preserve microvascular integrity and have beneficial effects on myocardial microcirculation .


The purpose of this study was to test the feasibility of a parent-briefing intervention for parents of hospitalized children with complex healthcare needs .


A phase I , single-group , posttest study .


There were @ physicians , @ nurses , and @ parents who participated in the study .


Participants were asked to sit while carrying out the briefings with parents .


Parents and clinicians completed a feasibility questionnaire post briefings .


Sixty-eight briefings were carried out .


Parents and nurses evaluated the briefings in a favorable manner , whereas physicians ' ratings were mixed .


Further inquiry is recommended to understand the effects of a structured communication intervention on parent-professional decision-making practices .


Sometimes a written advance directive contradicts the opinion of a health care proxy .


How this affects doctors ' decision making is unknown .


To quantify the influence of contradictory instructions on doctors ' decisions .


All the generalists and internists in French-speaking Switzerland were mailed the questionnaire .


Respondents ( @ % ) evaluated three vignettes that described medical decisions for incapacitated patients .


Each vignette was produced in four versions : one with an advance directive , one with a proxy opinion , one with both , and one with neither ( control ) .


In the first vignette , the directive and proxy agreed on the recommendation to forgo a medical intervention ; in the second , the advance directive opposed , but the proxy favored the intervention ; and in the third , the roles were reversed .


Each doctor received one version of each vignette , attributed at random .


The outcome variables were the doctor 's decision to forgo the medical intervention and the rating of the decision as difficult .


Written advance directives and proxy opinions significantly influenced doctors ' decision making .


When both were available and concordant , they reinforced each other ( odds ratio -LSB- OR -RSB- of forgoing intervention @ , P < @ compared with no instruction ) .


When the directive and proxy disagreed , the resulting effect was to forgo the intervention ( ORs @ and @ for the two discordant vignettes , both P < @ ) .


Discordance between instructions was associated with increased odds of doctors rating the decision as difficult ( both ORs @ , P @ ) .


Contradictions between advance directives and proxy opinions result in a weak preference for abstention from treatment and increase the difficulty of the decision .


To investigate the feasibility of a computer-based reading intervention completed by patients diagnosed with a brain tumor .


Patients were randomized to the intervention ( n = @ ) or standard of care group ( n = @ ) .


The intervention consisted of @ sessions using Fast ForWord exercises in a game-like format .


Change in reading decoding scores over time since diagnosis was examined .


Gender , race , parent education , parent marital status , and age at diagnosis were examined as covariates .


@ patients ( @ % ) were able to complete the target goal of @ intervention sessions .


Females had significantly greater training time than males ( p = @ ) .


Age at diagnosis was associated with average training time/session for females ( r = @ , p = @ ) .


No significant differences were found in reading scores between the randomized groups .


The study was well accepted by families and adherence by patients undergoing radiation therapy for medulloblastoma was moderate .


Suggestions for improved methodology are discussed .


To assess the efficacy of a heparin-surface-modified ( HSM ) hydrophobic acrylic intraocular lens ( IOL ) ( EC-@YH PAL ) and the same IOL without heparin coating ( EC-@Y-PAL ) by the flare and cell intensity in the anterior chamber after uneventful cataract surgery .


Department of Ophthalmology , Paracelsus Medical University Salzburg , Austria .


Comparative case series .


Routine phacoemulsification with randomized implantation of an HSM IOL in @ eye ( HSM IOL group ) and an uncoated IOL ( uncoated IOL group ) in the fellow eye was performed .


Postoperative inflammation was assessed objectively using a laser flare-cell meter ( FM-@ ) preoperatively as well as @ day and @ and @ months postoperatively .


Aqueous cells in the anterior chamber , distance visual acuities , and subjective manifest refraction were also evaluated at each visit .


One hundred eyes ( @ patients ) were enrolled .


In both groups , the mean flare values increased significantly from preoperatively to @ day postoperatively ( P < @ ) and nearly reached preoperative values by @ months postoperatively .


One day postoperatively , the mean flare value was statistically significantly lower in the HSM IOL group ( @ photons per millisecond -LSB- ph/ms -RSB- @ -LSB- SD -RSB- ) than in the uncoated IOL group ( mean @ @ ph/ms ) ( P = @ ) ; there was no statistically significant difference between groups @ and @ months postoperatively ( both P > @ ) .


The HSM IOL group had a greater and quicker decrease in aqueous cells , reaching statistical significance @ month postoperatively ( P = @ ) .


The HSM IOL showed a significant lower inflammatory reaction in the early postoperative stage with a faster disappearance of inflammatory signs .


Propofol is commonly used for induction and maintenance of anesthesia , but pain at the site of intravenous injection is a clinical problem .


We studied the effectiveness of local cooling and pretreatment with lidocaine for prevention of injection pain of propofol .


A total of @ adult patients scheduled to receive general anesthesia were assigned randomly to four groups : a control group receiving no prophylactic intervention , a cooling group receiving topical cooling , a lidocaine group receiving @ mg x kg ( -@ ) lidocaine , and a lidocaine plus cooling group receiving topical cooling and @ mg x kg ( -@ ) lidocaine .


A @ gauge intravenous catheter was inserted into the peripheral vein at the radial side of the forearm .


After prophylactic intervention had been performed , @-@ mg x kg ( -@ ) MCT/LCT propofol was injected .


Patients were asked to grade the pain as none , mild , moderate , or severe .


The incidence of propofol-induced pain was significantly higher in the control group ( @ % ) than in the other three groups ( @ % in the cooling group , @ % in the lidocaine group and @ % in the lidocaine plus cooling group ) .


However , there were no significant differences between the three groups with different prophylactic interventions .


The results suggest that cooling and pretreatment with lidocaine reduce the incidence of pain upon propofol injection .


Diabetes mellitus and heart failure frequently coexist .


However , few diabetes mellitus trials have prospectively evaluated and adjudicated heart failure as an end point .


A total of @ patients with type @ diabetes mellitus and a history of , or at risk of , cardiovascular events were randomized to saxagliptin or placebo ( mean follow-up , @ years ) .


The primary end point was the composite of cardiovascular death , myocardial infarction , or ischemic stroke .


Hospitalization for heart failure was a predefined component of the secondary end point .


Baseline N-terminal pro B-type natriuretic peptide was measured in @ patients .


More patients treated with saxagliptin ( @ , @ % ) were hospitalized for heart failure compared with placebo ( @ , @ % ; hazard ratio , @ ; @ % confidence intercal , @-@ @ ; P = @ ) .


Corresponding rates at @ months were @ % versus @ % ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) , with no significant difference thereafter ( time-varying interaction , P = @ ) .


Subjects at greatest risk of hospitalization for heart failure had previous heart failure , an estimated glomerular filtration rate @ mL/min , or elevated baseline levels of N-terminal pro B-type natriuretic peptide .


There was no evidence of heterogeneity between N-terminal pro B-type natriuretic peptide and saxagliptin ( P for interaction = @ ) , although the absolute risk excess for heart failure with saxagliptin was greatest in the highest N-terminal pro B-type natriuretic peptide quartile ( @ % ) .


Even in patients at high risk of hospitalization for heart failure , the risk of the primary and secondary end points were similar between treatment groups .


In the context of balanced primary and secondary end points , saxagliptin treatment was associated with an increased risk or hospitalization for heart failure .


This increase in risk was highest among patients with elevated levels of natriuretic peptides , previous heart failure , or chronic kidney disease .


Sturge-Weber syndrome ( SWS ) is characterized by port-wine stains ( PWS ) affecting the face , eyes , and central nervous system .


Pulsed dye laser ( PDL ) is the standard treatment for PWS .


Unfortunately , recurrence is frequent because of reformation and reperfusion of blood vessels .


We sought to assess the clinical efficacy of topical rapamycin combined with PDL in PWS of patients with SWS .


We conducted a phase II , randomized , double-blind , intraindividual placebo-controlled , clinical trial .


We recruited @ patients with SWS and facial PWS ( @ women ; median age @ years , age range @-@ years ) from the University Clinic of Navarra , Spain .


Four interventions were evaluated : placebo , PDL + placebo , rapamycin , and PDL + rapamycin .


Clinical and histologic responses were evaluated using a chromatographic computerized system , spectrometry , and histologic analyses at @ , @ , and @ weeks after the intervention .


PDL + rapamycin yielded the lowest digital photographic image score and the lowest percentage of vessels in histologic analysis , and showed a statistically significant improvement compared with the other interventions .


The treatment was generally well tolerated .


PDL was only applied to the lateral parts of the PWS area .


Topical rapamycin associated with PDL seems to be an effective treatment for PWS in patients with SWS .


Sedative premedication is widely administered before surgery , but little clinical evidence supports its use .


To assess the efficacy of sedative premedication on perioperative patient experience .


A randomized clinical trial , the PremedX study , enrolled @ adult patients who were younger than @ years and had been scheduled for various elective surgeries under general anesthesia at @ French teaching hospitals ( in Marseille , Montpellier , Nimes , and Nice ) between January @ and June @ .


Neurosurgery , obstetrical , cardiac , and outpatient surgery were excluded .


Patients were randomized to @ groups of @ participants each to receive @ mg of lorazepam , no premedication , or placebo .


The primary outcome was perioperative patient experience assessed @ hours after surgery with a validated questionnaire ( Evaluation du Vcu de l'Anesthsie Generale ; EVAN-G ) describing @ domains of satisfaction and a global index ( score range , @-@ ; high scores represent high satisfaction ) ; secondary outcomes included time to extubation and early cognitive recovery .


A subgroup analysis was planned a priori in patients with a high level of preoperative anxiety .


Premedication with lorazepam did not improve the EVAN-G mean global index for overall level of patient satisfaction ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) compared with no premedication ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) or placebo ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) ( P = @ ) .


Among patients with heightened preoperative anxiety , there were no significant differences found in the EVAN-G mean global index between the lorazepam group ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) and the no premedication group ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) or the placebo group ( @ -LSB- @ % CI , @-@ -RSB- ; n = @ ) ( P = @ ) .


Time to extubation was @ minutes ( @ % CI , @-@ minutes ) in the lorazepam group , @ minutes ( @ % CI , @-@ minutes ) for the no premedication group , and @ minutes ( @ % CI , @-@ minutes ) for the placebo group ( P < @ ) and the rate of early cognitive recovery was @ % ( @ % CI , @ % -@ % ) , @ % ( @ % CI , @ % -@ % ) , and @ % ( @ % CI , @ % -@ % ) , respectively ( P < @ ) .


Among patients undergoing elective surgery under general anesthesia , sedative premedication with lorazepam compared with placebo or no premedication did not improve the self-reported patient experience the day after surgery , but was associated with modestly prolonged time to extubation and a lower rate of early cognitive recovery .


The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia .


To investigate the effectiveness of a neck strengthening program on the isometric neck strength profile of male rugby union players .


Controlled laboratory study .


Professional rugby union club .


Fifteen professional and @ semiprofessional rugby union players .


The @ professional players undertook a @-week neck strengthening intervention , which was performed twice per week , whereas the @ semiprofessional players acted as the control group .


Isometric strength of the neck musculature was tested using a hand-held dynamometer , for flexion ( F ) , extension ( E ) , left-side flexion ( LSF ) , and right-side flexion ( RSF ) .


Preintervention and postintervention evaluations were undertaken .


No significant between-group differences in isometric neck strength were noted preintervention .


A significant main effect for time was observed ( P < @ ) , whereby the intervention group increased isometric neck strength in all planes after the @-week intervention ( F preintervention = @ @ N vs F postintervention @ @ N ; E preintervention = @ @ vs E postintervention = @ @ N ; LSF preintervention = @ @ N vs LSF postintervention = @ @ N ; RSF preintervention = @ @ N vs RSF postintervention = @ @ N ) .


No significant improvement in neck strength was observed for control group participants .


The results of the present study indicate that a @-week neck strengthening program improves isometric neck strength in rugby union players , which may have implications for injury prevention , screening , and rehabilitation .


The strengthening program described in the present study may facilitate rehabilitation specialists in the development of neck injury prevention , screening , and rehabilitation protocols .


In the ` Tailored Implementation for Chronic Diseases ( TICD ) ' project , five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed .


These programs will be evaluated in distinct cluster-randomized controlled trials .


This protocol describes the process evaluation across these trials , which aims to identify determinants of change in chronic illness care , to examine the validity of the tailoring methods that were applied , and to analyze the association of implementation activities and the effectiveness of the program .


A multilevel approach was used to develop five tailored implementation interventions .


In order to guide the process evaluation in five distinct trials , the study protocols for the cluster randomized trials and the related process evaluations were developed simultaneously and iteratively .


The process evaluation comprises three main components : a structured survey with health professionals in the trials , semi-structured interviews with a purposeful sample of this study population , and standardized documentation of organizational practice characteristics .


Norway will only conduct the qualitative part of the analysis because the survey and documentation of practice characteristics are considered to be not feasible .


The evaluation is guided by ` logic models ' of the implementation programs : frameworks that specify the linkages between the strategies used , the determinants addressed by tailoring , and the anticipated outcomes .


Standardization of measures across trials is sought to facilitate analysis of aggregated data from the trials .


This process evaluation will need to find a balance between standardization of methods across trials and the tailoring of measures to the specificities of each trial .


Therapeutic hypothermia is the standard of care after perinatal asphyxia .


Preclinical studies show @ % xenon improves outcome , if started early .


During a @-patient study randomized between hypothermia only and hypothermia with xenon , @ neonates were given xenon during retrieval using a closed-circuit incubator-mounted system .


Without xenon availability during retrieval , @ % of eligible infants exceeded the @-hour treatment window .


With the transportable system , @ % were recruited .


Xenon delivery lasted @ to @ minutes , using @ mL/h ( @-@ @ ) ( median -LSB- interquartile range -RSB- ) , after circuit priming ( @ mL ) .


Xenon delivery during ambulance retrieval was feasible , reduced starting delays , and used very little gas .


Detrimental effects of right ventricular ( RV ) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum .


As safety data are scarce for implantable cardioverter defibrillator ( ICD ) recipients the study aims to evaluate ICD lead performance in the mid-septal position .


A total of @ ICD recipients ( @ % male , aged @ @ years , @ % primary prevention of sudden cardiac death ) were randomized to receive the RV ICD electrode either in a mid-septal ( n = @ ) or apical ( n = @ ) location .


Event-free survival was evaluated at @ ( primary endpoint ) and @ months ( secondary endpoint ) .


Events included a composite of lead revision , suboptimal right ventricular electrode performance ( including defibrillation thresholds ( DFT ) > @ J ) or lead position not in accordance with randomized location .


Event-free survival at @ ( @ ) months was observed in @ % ( @ % ) of patients randomized to a mid-septal and in @ % ( @ % ) of patients randomized to an apical lead position , p = @ ( p = @ ) .


Pre-defined margins for non-inferiority were not reached at @ or @ months .


High DFT was found in @ patients ( @ % ) of the mid-septal and in @ ( @ % ) patients of the apical group ( p = @ ) .


In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision , suboptimal right ventricular electrode performance or non-randomized lead position .


Non-inferiority of the mid-septal lead location can not be concluded .


This should be taken into consideration when a mid-septal lead position is pursued .


To make a randomized comparison of @ consolidation treatment options ( two patient groups ) : @ cycles of cytarabine in average ( Ig/m@ in Group @ ) and standard ( @ mg/mi@ in Group @ ) doses in combination with idarubicin ( @-@ mg/m@ ) and mitoxantrone ( @ mg/m@ ) , after two @ +@ induction cycles of daunorubicin ( @ mg/mi@ ) and subsequent @ cycles of maintenance therapy .


In January @ to October @ , a Russian multicenter trial was conducted to treat patients with acute myeloid leukemias ( AML ) in accordance with the AML-@ @ protocol ( ClinicalTrials.gov Identifier : NCT@ ) .


The trial enrolled @ AML patients from @ centers , including @ patients ( median age @ years ) from the State Hematology Center , Ministry of Health of the Russian Federation ; @ and @ patients were randomized to Groups @ and @ , respectively .


The randomized groups were balanced by basic clinical and laboratory parameters .


Favorable , intermediate , and high cytogenetic prognoses were in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients , respectively .


Prior to treatment , @ patients died ; one patient refused treatment .


Fifty-eight ( @ % ) of the @ patients achieved complete remission ( CR ) ; early deaths was in @ ( @ % ) and resistance in @ ( @ % ) .


Four ( @ % ) patients died during CR .


Protocol deviations ( doses , intervals , and the number of cycles ) were recorded in @ ( @ % ) of the @ patients .


Other @ ( @ % ) patients were switched to low-dose cytarabine because of complications , withdrawn from the protocol and not included into the analysis of randomized comparison .


Twenty allogeneic bone marrow transplantations ( allo-BMT ) ( @ related , @ unrelated , and @ haploidentical ) were performed ; of them @ allo-BMTs were done during first CR .


In the @ patients , @-year overall survival ( OS ) was @ % ; relapse-free survival ( RFS ) was @ % .


OS was @ % in Group @ and @ % in Group @ ; RFS was @ and @ % in Groups @ and @ , respectively ( p > @ ) .


In the favorable , intermediate , and high prognosis groups , OS was @ , @ , and @ % and RFS was @ , @ , and @ % , respectively ( p = @ ) .


The consolidation treatment option unchanged survival rates in the above risk groups .


Unachieved CR after the first cycle considerably decreased RFS ( @ % versus @ % ) and served as an indication for allo-BMT during first CP ( RFS without BMT was @ ; that with BMT was @ % ) .


No differences were found between both consolidation options according to long-term results .


Protocol deviations were recorded in one-third of the patients .


While implementing the protocol , the efficiency of treatment was high .


Allo-BMT during first CR substantially increased RFS if CP was not achieved after the first cycle .


We investigate the effect of @ months aerobic training alone or in combination with diet on adiponectin in circulation and in adipose abdominal tissue ( AT ) in obese women .


Twenty obese subjects were randomized into a @ weeks intervention : @ ) training ( TR ) and @ ) training and diet ( TRD ) .


Blood samples were collected at baseline , after @ wk and @ wk .


AT biopsies were obtained only at baseline and after @ wk .


In the TRD group the fat loss was after @ wk -@ % ( p < @ ) and after @ wk -@ % ( p < @ ) with no changes in the TR group .


After @ and @ wk , VO@max was increased by @-@ @ % ( p < @ ) in the TRD group and @-@ @ % in the TR group ( p < @ ) .


After @ wk , plasma adiponectin was raised only in the TRD group ( @ % , p < @ ) .


After @ weeks , circulating adiponectin was elevated by @ % ( p < @ ) in the TRD group and by @ % ( p < @ ) in the TR group .


In AT biopsies , subjects in the TRD and TR groups exhibited a significant increase in adiponectin ( p < @ and p < @ , respectively ) .


The two indices HOMA-IR and HOMA-AD for assessing insulin resistance were strongly affected by protocols .


HOMA-IR decreased ( p < @ ) only after @ wk in the TRD group .


HOMA-AD increased in both groups after @ ( p < @ ) and @ wk ( p < @ ) .


Six months chronic aerobic exercise alone or combined with diet result in a significant increase in circulating and adipose tissue adiponectin levels in obese women independent of changes in body composition and/or in HOMA-IR .


Infantile spasms ( IS ) are a severe form of childhood epilepsy associated with autism spectrum disorders ( ASD ) in up to @ % of cases .


The objective of this post hoc analysis of our randomized control trial was to determine whether rapid diagnosis and treatment of IS could limit the incidence of ASD while identifying risk factors related to ASD outcome .


Patients with IS were randomized in a standardized diagnostic and treatment protocol .


Clinical and electroencephalogram ( EEG ) evaluations were completed at all eight visits over @ years , while cognitive evaluations were administered at @ , @ , @ and @ months , respectively .


Autism was initially screened by means of the Checklist for Autism in Toddlers ( CHAT ) at @ months , and formally assessed at the @-and @-month follow-ups using the Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) .


Of the @ patients included in the study , @ could not be assessed due to severe delay or death .


Eleven of the @ patients screened with CHAT , were found to be at risk of an ASD outcome .


ADOS was performed in @ and @ were diagnosed with ASD .


The CHAT proved to correlate highly with the ADOS ( @ % ppv ) .


Only patients with symptomatic IS developed ASD ( p = @ ) .


Earlier diagnosis or successful treatment did not correlate with a reduced rate of ASD .


Other risk factors were identified such as having chronic epileptic discharges in the frontotemporal areas after disappearance of hypsarrhythmia ( p = @ and p = @ ) and being of nonwhite origin ( p = @ ) .


ASD was only observed in children with sympyomatic IS .


Other clinical risk factors include chronic frontotemporal epileptic activity and being of non-white origin .


Early diagnosis and treatment did not prevent ASD as an outcome of IS .


However , patients at risk for ASD could be identified early on and should in the future benefit from early intervention to potentially improve their long-term outcome .


Examine a protective crumple zone effect of paranasal sinuses and nasal cavity on skull base fractures .


Randomized-control , cadaveric study .


In the experimental group ( n = @ ) , the nasal cavity and bilateral sinuses of cadavers were obliterated with bone cement , whereas the control group ( n = @ ) had native sinus architecture .


Increasing frontal , glabellar impacts were introduced .


Each impact event was examined with a high-speed video camera and sphenoid sinus pressure sensor .


After each impact , computed tomography scans were performed and fracture sites were analyzed .


The control group with intact sinuses showed statistically longer time duration , during which kinetic energy transfer occurred , and longer sphenoid wall pressure equilibrium time after an impact ( P < @ ) .


In the experimental group , there were statistically higher fracture incidences of clivus , petrous portion of internal carotid , occipital bone , and foramen magnum ( P < @ ) .


The type A pattern ( n = @ ) had anterior skull base failure occurring before posterior skull base failure .


Type B pattern ( n = @ ) , seen only in two experimental specimens , is marked by premature posterior skull base collapse occurring before anterior skull base failure with grossly disrupted posterior cranial fossa structures .


The presence of nasal cavity and paranasal sinuses behaves as a crumple zone to protect the cranial structures , preferentially posterior cranial fossa .


Obliteration of the nasal cavity and paranasal sinuses with bone cement significantly increased structural tolerance of the anterior cranial vault to frontal , glabellar impacts at the cost of premature , posterior cranial fossa failure .


The orexin-hypocretin system is important for translating peripheral metabolic signals and central neuronal inputs to a diverse range of behaviors , from feeding , motivation and arousal , to sleep and wakefulness .


Orexin signaling is thus an exciting potential therapeutic target for disorders of sleep , feeding , addiction , and stress .


Here , we investigated the low dose pharmacology of orexin receptor antagonist , SB-@ , on neuroendocrine , sympathetic nervous system , and behavioral responses to insulin-induced hypoglycemic stress , in @ healthy male subjects ( aged @-@ years ; BMI @-@ @ kg/m ( @ ) ) , using a randomized , double-blind , placebo-controlled , within-subject crossover design .


Alprazolam , a licensed benzodiazepine anxiolytic , was used as a positive comparator , as it has previously been validated using the insulin tolerance test ( ITT ) model in humans .


Of the primary endpoints , ITT induced defined increases in pulse rate , plasma cortisol , and adrenocorticotropic hormone in the placebo condition , but these responses were not significantly impacted by alprazolam or SB-@ pre-treatment .


Of the secondary endpoints , ITT induced a defined increase in plasma concentrations of adrenaline , noradrenaline , growth hormone ( GH ) , and prolactin in the placebo condition .


Alprazolam pre-treatment significantly reduced the GH response to ITT ( p < @ ) , the peak electromyography ( p < @ ) and galvanic skin response ( GSR , p = @ ) to acoustic startle , the resting GSR ( p = @ ) , and increased appetite following ITT ( p < @ ) .


SB-@ pre-treatment produced no significant results .


We concluded that the ITT model may be informative for assessing the effects of drugs directly acting on the neuroendocrine or sympathetic nervous systems , but could not be validated for studying low dose orexin antagonist activity .


The purpose of the current study was to pilot-test a positive psychology intervention to improve adherence to diabetes management in adolescents with type @ diabetes .


A total of @ adolescents ( ages , @-@ years ) with type @ diabetes and their caregivers were randomized to a positive psychology intervention ( n = @ ) or an attention control ( education ) intervention ( n = @ ) .


The intervention condition used positive psychology exercises ( eg , gratitude , self-affirmation ) , small gifts , and parent affirmations to boost positive affect .


Outcomes included frequency of blood glucose monitoring , quality of life , and glycemic control .


No main effects for treatment were observed at the @-month follow-up .


However , there was a significant association between adolescents ' levels of positive affect and measures of adherence , including self-report and meter downloads of glucose monitoring .


The results from the current study support the assertion that positive affect in the context of diabetes education is an important factor to consider in adolescents with type @ diabetes .