Verbal and written guidelines for aerobic exercise , together with supervision over the telephone , had a positive impact on the self-reported regular physical exercise practice of children and adolescents .


However , no improvement was found in lung function and maximum exercise capacity or domains of the quality of life questionnaire .


The stepped care program Bridging Intervention in Anesthesiology ( BRIA ) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options .


This study examined the efficacy of BRIA .


This randomized , parallel-group , open-label , controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany .


A total of 220 surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups : BRIA psychotherapy sessions up to 3 months postoperatively ( BRIA ) versus no psychotherapy/computerized brief written advice ( BWA ) only .


Primary outcome was participation in psychosocial mental healthcare options at month 6 .


Secondary outcome was change of self-reported general psychological distress ( Global Severity Index of the Brief Symptom Inventory ) between baseline and month 6 .


At 6-month follow-up , the rate of patients who engaged in psychosocial mental healthcare options was 30 % ( 33 of 110 ) in BRIA compared with 11.8 % ( 13 of 110 ) in BWA ( P = 0.001 ) .


Number needed to treat and relative risk reduction were 6 ( 95 % CI , 4 to 13 ) and 0.21 ( 0.09 to 0.31 ) , respectively .


In BRIA , Global Severity Index decreased between baseline and month 6 ( P < 0.001 ) , whereas it did not change significantly in BWA ( P = 0.197 ) .


Among surgical patients with comorbid mental disorders , BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress .


These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care .


This study investigated the effects of fatty fish on sleep , daily functioning and biomarkers such as heart rate variability ( HRV ) , vitamin D status ( serum 25-hydroxyvitamin D ( 25OHD ) , and eicosapentaenoic acid ( EPA , 20:5 n-3 ) + docosahexaenoic acid ( DHA , 22:6 n-3 ) in red blood cells .


Moreover the relationship among sleep , daily functioning , HRV , vitamin D status , and levels of EPA+DHA was investigated .


Ninety-five male forensic patients from a secure forensic inpatient facility in the USA were randomly assigned into a Fish or a Control group .


The Fish group received Atlantic salmon three times per week from September to February , and the Control group was provided an alternative meal ( e.g. , chicken , pork , beef ) , but with the same nutritional value as their habitual diet , three times per week during the same period .


Sleep ( sleep latency , sleep efficiency , actual sleep time , and actual wake time ) , self-perceived sleep quality and daily functioning , as well as vitamin D status , EPA+DHA , and HRV , were assessed pre - and post-intervention period .


There was a significant increase in sleep latency from pre - to post-test in the Control group .


The Fish group reported better daily functioning than the Control group during post-test .


Fish consumption throughout the wintertime had also an effect on resting HRV and EPA+DHA , but not on vitamin D status .


However , at post-test , the vitamin D status in the Fish group was still closer to the level regarded as optimal compared to the Control group .


Vitamin D status correlated negatively with actual wake time and positively with sleep efficiency during pre-test , as well as positively with daily functioning and sleep quality during post-test .


Finally , HRV correlated negatively with sleep latency and positively with daily functioning .


Fish consumption seemed to have a positive impact on sleep in general and also on daily functioning , which may be related to vitamin D status and HRV .


Neurocysticercosis ( NCC ) is a major cause of seizures and epilepsy in endemic countries .


Antiparasitic treatment of brain cysts leads to seizures due to the host 's inflammatory reaction , requiring concomitant steroids .


We hypothesized that increased steroid dosing will reduce treatment-associated seizures .


Open-label randomized trial comparing 6 mg/day dexamethasone for 10 days ( conventional ) with 8 mg/day for 28 days followed by a 2-week taper ( enhanced ) in patients with NCC receiving albendazole .


Follow-up included active seizure surveillance and brain imaging .


Study outcomes were seizure days and patients with seizures , both measured in days 11-42 .


Additional analyses compared days 1-10 , 11-21 , 22-32 , 33-42 , 43-60 , and 61-180 .


Thirty-two individuals were randomized into each study arm ; two did not complete follow-up .


From days 11 to 42 , 59 partial and 6 generalized seizure days occurred in 20 individuals , nonsignificantly fewer in the enhanced arm ( 12 vs. 49 , p = 0.114 ) .


The numbers of patients with seizures in this period showed similar nonsignificant differences .


In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment ( days 1-10 : 4 vs. 17 , p = 0.004 , and 1 vs. 10 , p = 0.003 , number needed to treat [ NNT ] 4.6 , relative risk [ RR ] 0.1013 , 95 % confidence interval [ CI ] 0.01-0 .74 ) and early after dexamethasone cessation ( days 11-21 : 6 vs. 27 , p = 0.014 , and 4 vs. 12 , p = 0.021 , NNT 4.0 , RR 0.33 , 95 % CI 0.12-0 .92 ) but not after day 21 .


There were no significant differences in antiparasitic efficacy or relevant adverse events .


Increased dexamethasone dosing results in fewer seizures for the first 21 days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first 11-42 days , which was the primary predetermined time of analysis .


A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest , but such a strategy has not been tested in large clinical trials .


To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions ( mechanical CPR ) , compared with manual cardiopulmonary resuscitation ( manual CPR ) , according to guidelines , would improve 4-hour survival .


Multicenter randomized clinical trial of 2589 patients with out-of-hospital cardiac arrest conducted between January 2008 and February 2013 in 4 Swedish , 1 British , and 1 Dutch ambulance services and their referring hospitals .


Duration of follow-up was 6 months .


Patients were randomized to receive either mechanical chest compressions ( LUCAS Chest Compression System , Physio-Control/Jolife AB ) combined with defibrillation during ongoing compressions ( n = 1300 ) or to manual CPR according to guidelines ( n = 1289 ) .


Four-hour survival , with secondary end points of survival up to 6 months with good neurological outcome using the Cerebral Performance Category ( CPC ) score .


A CPC score of 1 or 2 was classified as a good outcome .


Four-hour survival was achieved in 307 patients ( 23.6 % ) with mechanical CPR and 305 ( 23.7 % ) with manual CPR ( risk difference , -0.05 % ; 95 % CI , -3.3 % to 3.2 % ; P > .99 ) .


Survival with a CPC score of 1 or 2 occurred in 98 ( 7.5 % ) vs 82 ( 6.4 % ) ( risk difference , 1.18 % ; 95 % CI , -0.78 % to 3.1 % ) at intensive care unit discharge , in 108 ( 8.3 % ) vs 100 ( 7.8 % ) ( risk difference , 0.55 % ; 95 % CI , -1.5 % to 2.6 % ) at hospital discharge , in 105 ( 8.1 % ) vs 94 ( 7.3 % ) ( risk difference , 0.78 % ; 95 % CI , -1.3 % to 2.8 % ) at 1 month , and in 110 ( 8.5 % ) vs 98 ( 7.6 % ) ( risk difference , 0.86 % ; 95 % CI , -1.2 % to 3.0 % ) at 6 months with mechanical CPR and manual CPR , respectively .


Among patients surviving at 6 months , 99 % in the mechanical CPR group and 94 % in the manual CPR group had CPC scores of 1 or 2 .


Among adults with out-of-hospital cardiac arrest , there was no significant difference in 4-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline-adherent manual CPR .


The vast majority of survivors in both groups had good neurological outcomes by 6 months .


In clinical practice , mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR .


clinicaltrials.gov Identifier : NCT00609778 .


Parkinson 's disease ( PD ) has a progressive course and is characterized by the degeneration of dopaminergic neurons .


Although no neuroprotective treatments for PD have been found to date , the endocannabinoid system has emerged as a promising target .


From a sample of 119 patients consecutively evaluated in a specialized movement disorders outpatient clinic , we selected 21 PD patients without dementia or comorbid psychiatric conditions .


Participants were assigned to three groups of seven subjects each who were treated with placebo , cannabidiol ( CBD ) 75 mg/day or CBD 300 mg/day .


One week before the trial and in the last week of treatment participants were assessed in respect to ( i ) motor and general symptoms score ( UPDRS ) ; ( ii ) well-being and quality of life ( PDQ-39 ) ; and ( iii ) possible neuroprotective effects ( BDNF and H ( 1 ) - MRS ) .


We found no statistically significant differences in UPDRS scores , plasma BDNF levels or H ( 1 ) - MRS measures .


However , the groups treated with placebo and CBD 300 mg/day had significantly different mean total scores in the PDQ-39 ( p = 0.05 ) .


Our findings point to a possible effect of CBD in improving quality of life measures in PD patients with no psychiatric comorbidities ; however , studies with larger samples and specific objectives are required before definitive conclusions can be drawn .


Gait training for patients with hemiparesis is carried out independently overground or on a treadmill .


Several studies have shown differences in hemiparetic gait parameters during overground versus treadmill walking .


However , few studies have compared the effects of these 2 gait training conditions on gait parameters , and no study has compared the short-term effects of these techniques on all biomechanical gait parameters .


To determine whether a gait training session performed overground or on a treadmill induces specific short-term effects on biomechanical gait parameters in patients with hemiparesis .


Twenty-six subjects with hemiparesis were randomly assigned to a single session of either overground or treadmill gait training .


The short-term effects on spatiotemporal , kinematic , and kinetic gait parameters were assessed using gait analysis before and immediately after the training and after a 20-minute rest .


Speed , cadence , percentage of single support phase , peak knee extension , peak propulsion , and braking on the paretic side were significantly increased after the gait training session .


However , there were no specific changes dependent on the type of gait training performed ( overground or on a treadmill ) .


A gait training session performed by subjects with hemiparesis overground or on a treadmill did not induce specific short-term effects on biomechanical gait parameters .


The increase in gait velocity that followed a gait training session seemed to reflect specific modifications of the paretic lower limb and adaptation of the nonparetic lower limb .


Virtual visits through web-based video conferencing can increase access to specialty care for individuals with Huntington disease ( HD ) and facilitate research participation .


To determine the feasibility of conducting virtual visits directly into the homes of individuals with HD , to assess the reliability of conducting remote versus in-person motor assessments , and to determine the test-retest reliability of conducting motor assessments remotely .


Individuals with mild to moderate HD underwent baseline in-person clinic assessments and completed a HD care survey .


Participants were randomized to receive three virtual visits from one of two physicians over four months that included a modified Unified Huntington 's Disease Rating Scale motor examination ( excluding rigidity and balance assessments ) via web-based video conferencing .


Intraclass coefficients ( ICC ) were calculated to determine the level of agreement between remote and in-person assessments .


Participants also completed a survey on their interest in telemedicine .


Thirteen individuals underwent baseline assessments , eleven ( 85 % ) participants completed at least one virtual visit , and 27 ( 82 % ) of 33 total virtual visits were completed .


Remote motor scores demonstrated good reliability ( ICC = 0.78 ; n = 11 ) compared to in-person motor scores .


Test-retest reliability of motor scores conducted remotely was excellent ( ICC = 0.90 ; n = 11 ) .


Participants expressed moderate future interest in using virtual visits to participate in research and to receive care .


In this pilot study , virtual visits into the home were feasible and reliable for conducting motor assessments in HD .


Larger scale studies need to confirm and generalize these findings to a broader population of participants .


To improve adolescent notification of positive sexually transmitted infection ( STI ) tests using mobile phone technology and STI information cards .


A randomized intervention among 14 - to 21-year olds in a pediatric emergency department ( PED ) .


A 2 3 factorial design with replication was used to evaluate the effectiveness of six combinations of two factors on the proportion of STI-positive adolescents notified within 7days of testing .


Independent factors included method of notification ( call , text message , or call + text message ) and provision of an STI information card with or without a phone number to obtain results .


Covariates for logistic regression included age , empiric STI treatment , days until first attempted notification , and documentation of confidential phone number .


Approximately half of the 383 females and 201 males enrolled were 18years of age .


Texting only or type of card was not significantly associated with patient notification rates , and there was no significant interaction between card and notification method .


For females , successful notification was significantly greater for call + text message ( odds ratio , 3.2 ; 95 % confidence interval , 1.4-6 .9 ) , and documenting a confidential phone number was independently associated with successful notification ( odds ratio , 3.6 ; 95 % confidence interval , 1.7-7 .5 ) .


We found no significant predictors of successful notification for males .


Of patients with a documented confidential phone number who received a call + text message , 94 % of females and 83 % of males were successfully notified .


Obtaining a confidential phone number and using call + text message improved STI notification rates among female but not male adolescents in a pediatric emergency department .


To investigate biochemically whether total intravenous anesthesia ( TIVA ) using propofol creates a risk for Propofol Infusion Syndrome ( PRIS ) .


Forty patients scheduled for thyroid gland surgery were randomly assigned into Group T or C and premedicated 30 min before operation .


Group T received remifentanyl hydrochloride , propofol infusion following anesthesia induction with propofol , vecuronium bromide and intubation .


Group C received remifentanyl hydrochloride infusion , 1-1 .5 MAC desflurane inhalation following anesthesia induction with thiopental , vecuronium bromide and intubation .


Patients were respired 50 % O2-air mixture .


Blood gas , potassium , lactic acid , CK-MB , myoglobin , troponin I , total carnitine , triglyceride , creatinine concentrations were determined before operation , at intraoperative hour-2 , postoperative hour-6 .


There were no significant differences between groups in potassium , lactic acid CK-MB , myoglobin , total carnitine or creatinine levels .


Triglyceride level at intraoperative hour-2 increased in Group T , decreased at postoperative hour-6 .


Troponin I was higher in Group C than Group T at intraoperative hour-2 ( p < 0.05 ) .


No asystole , bradycardia , arrhythmia , hypotension or change in urine color was detected .


The present biochemical findings suggest that TIVA using propofol is safe .


Traditional rotation-based models of placebo nausea are limited because they do not have vehicle settings and are tied to their context .


The present study introduces a new model for examining placebo-induced nausea in the laboratory that overcomes these limitations , namely , Galvanic Vestibular Stimulation ( GVS ) .


GVS stimulates the vestibular system to cause nausea through sensory mismatch with visual cues and importantly has a non-nauseating placebo setting .


Using this , we tested whether conditioning could elicit placebo nausea when participants were later exposed to placebo stimulation as well as whether this placebo nausea was generalised across contexts -- something that is extremely difficult to test with rotation-based models of placebo nausea .


Thirty healthy undergraduate students were randomised to receive either placebo GVS ( controls ) or active GVS during training ( Context-Consistent and Context-Change ) .


On test , all groups received placebo GVS .


The controls and Context-Consistent groups were tested in the same context as training , whereas the Context-Change group was tested in a new context .


Participants conditioned with nausea during training had significantly higher nausea symptom ratings after placebo stimulation on test than those given no conditioning .


This placebo-induced nausea also generalised to a novel test context with no differences observed between the Context-Change and Context-Consistent groups .


GVS provides a new model of placebo-induced nausea that overcomes limitations to traditional rotation-based paradigms .


Future studies should use this device to explore the effect of instructions and conditioning on the development of placebo nausea and to assess the efficacy of conditioning-based interventions for clinical use .


Contrasting results have been reported regarding the influence of the use of adhesive on biofilm formation .


The purpose of this study was to evaluate the influence of the use of adhesive on the formation of biofilm on the internal surface of complete dentures and the palatal mucosa of denture wearers .


Thirty participants with well-fitting complete dentures were randomly divided according to the experimental design : protocol 1 , adhesive use during the first 15 days , followed by no use of adhesive over the next 15 days ; protocol 2 , no use of adhesives during the first 15 days , followed by adhesive use over the next 15 days .


After each period , material from the mucosa and intaglio of the maxillary dentures was collected .


Replicate aliquots were plated onto Petri dishes containing selective media for Candida spp , Streptococcus mutans , and a nonselective culture medium .


Colony-forming units were expressed as log ( CFU +1 ) / mL .


In addition , the internal surfaces of the maxillary and mandibular complete dentures were stained and photographed .


From the photographs , the total internal surface and the surface stained with biofilm were quantified ( software ImageTool 3.00 ) , and the percentage of the biofilm-covered area ( % ) on the maxillary and mandibular dentures was calculated and compared with 2-way ANOVA .


For the nonselective culture medium , data were compared with the paired-sample t test , and the Wilcoxon signed rank test was performed to compare the colony counts of Candida spp and Streptococcus mutans ( = .05 ) .


Similar colony counts were found with or without the use of adhesive for the mucosa and internal surfaces of maxillary dentures , irrespective of the culture medium ( P > .05 ) .


The area of dentures covered with biofilm was influenced by the use of adhesive ( P = .025 ) , regardless of the type of denture ( P = .121 ) .


The use of adhesive did not alter the colony counts of microorganisms from the palatal mucosa and maxillary dentures of complete denture wearers during the 15-day period , but it did influence the area covered with biofilm on the internal surfaces of the complete dentures .


To compare the efficacy and tolerability of a low-volume ( 2-L ) polyethylene glycol ( PEG ) regimen for colonoscopy compared to single ( 4-L ) or split-dose ( 2-L +2 - L ) regimens .


In-hospital patients who were candidates for colonoscopy were randomly assigned to : group 1 single-dose ( PEG 4L the day before the study , n = 60 ) ; group 2 : split-dose ( 2L the day before and 2L on the day of the procedure , n = 61 ) ; and group 3 : low-volume 2-L PEG solution ( the day of the procedure , n = 59 ) .


A blinded evaluation of the quality of colonic preparation was assessed by the Boston bowel preparation scale .


Satisfactory bowel preparation of the right colon was more frequently reported for group 3 than for group 1 ( 70 % vs 53 % , P = 0.045 ) , in the transverse colon it was 82 % versus 69 % ( P = 0.032 ) , and on the left side of the colon it was 80 % versus 67.7 % ( P = 0.028 ) .


Compared to group 2 , satisfactory bowel preparation in group 3 was similar in the transverse colon and left colon .


Nausea , vomiting , and abdominal discomfort were less frequent in patients of group 3 .


Patients in group 3 had fewer sleep disorders and fewer hours of sleep loss compared to patients in the other groups .


Preparation with 2L caused less abdominal discomfort and fewer sleep disorders .


The split dose had a better quality of preparation in the right colon .


Both preparations were clearly better than the 4-L preparation .


Traditional Chinese medicine ( TCM ) is considered an important complementary therapy with beneficial effects for cancer patients .


Elderly patients with non-small-cell lung cancer ( NSCLC ) are a complex patient group with increasing co-morbidity and shrinking physiological reserve , and may derive substantial benefit from the supportive aspects of TCM .


Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer .


This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC .


This is a double-blind controlled , multi-center , and prospective study with randomly selected participants from elderly NSCLC patients in China .


Seventy-six patients who meet the inclusion criteria will be allocated into two groups , which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles .


Progression-free survival ( PFS ) is the primary end point , and the secondary end points are overall survival , objective response rate , time-to-progression , and quality of life ( EORTC QLQ-LC43 , and TCM syndrome score ) .


Meanwhile , other end points such as toxicity , side effects and safety of the treatments will be assessed .


Results from this study may provide evidence on the effectiveness , and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC .


ClinicalTrials.gov .


( Identifier : NCT01780181 ) .


Coadministration of a bacterial adjuvant with oral immunotherapy ( OIT ) has been suggested as a potential treatment for food allergy .


To evaluate a combined therapy comprising a probiotic together with peanut OIT .


We performed a double-blind , placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 and peanut OIT ( probiotic and peanut oral immunotherapy [ PPOIT ] ) in children ( 1-10 years ) with peanut allergy .


The primary outcome was induction of sustained unresponsiveness 2 to 5 weeks after discontinuation of treatment ( referred to as possible sustained unresponsiveness ) .


Secondary outcomes were desensitization , peanut skin prick test , and specific IgE and specific IgG4 measurements .


Sixty-two children were randomized and stratified by age ( 5 and > 5 years ) and peanut skin test wheal size ( 10 and > 10 mm ) ; 56 reached the trial 's end .


Baseline demographics were similar across groups .


Possible sustained unresponsiveness was achieved in 82.1 % receiving PPOIT and 3.6 % receiving placebo ( P < .001 ) .


Nine children need to be treated for 7 to achieve sustained unresponsiveness ( number needed to treat , 1.27 ; 95 % CI , 1.06-1 .59 ) .


Of the subjects , 89.7 % receiving PPOIT and 7.1 % receiving placebo were desensitized ( P < .001 ) .


PPOIT was associated with reduced peanut skin prick test responses and peanut-specific IgE levels and increased peanut-specific IgG4 levels ( all P < .001 ) .


PPOIT-treated participants reported a greater number of adverse events , mostly with maintenance home dosing .


This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy .


PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response .


Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT .


Atopic dermatitis ( AD ) is a common inflammatory skin disease with a global prevalence ranging from 3 % to 20 % .


Patients with AD have an increased risk for complications after viral infection ( eg , herpes simplex virus ) , and vaccination of patients with AD with live vaccinia virus is contraindicated because of a heightened risk of eczema vaccinatum , a rare but potentially lethal complication associated with smallpox vaccination .


We sought to develop a better understanding of immunity to cutaneous viral infection in patients with AD .


In a double-blind randomized study we investigated the safety and immunogenicity of live attenuated yellow fever virus ( YFV ) vaccination of nonatopic subjects and patients with AD after standard subcutaneous inoculation or transcutaneous vaccination administered with a bifurcated needle .


Viremia , neutralizing antibody , and antiviral T-cell responses were analyzed for up to 30 days after vaccination .


YFV vaccination administered through either route was well tolerated .


Subcutaneous vaccination resulted in higher seroconversion rates than transcutaneous vaccination but elicited similar antiviral antibody levels and T-cell responses in both the nonatopic and AD groups .


After transcutaneous vaccination , both groups mounted similar neutralizing antibody responses , but patients with AD demonstrated lower antiviral T-cell responses by 30 days after vaccination .


Among transcutaneously vaccinated subjects , a significant inverse correlation between baseline IgE levels and the magnitude of antiviral antibody and CD4 ( + ) T-cell responses was observed .


YFV vaccination of patients with AD through the transcutaneous route revealed that high baseline IgE levels provide a potential biomarker for predicting reduced virus-specific immune memory after transcutaneous infection with a live virus .


Optimal resuscitation of hypotensive trauma patients has not been defined .


This trial was performed to assess the feasibility and safety of controlled resuscitation ( CR ) versus standard resuscitation ( SR ) in hypotensive trauma patients .


Patients were enrolled and randomized in the out-of-hospital setting .


Nineteen emergency medical services ( EMS ) systems in the Resuscitation Outcome Consortium participated .


Eligible patients had an out-of-hospital systolic blood pressure ( SBP ) of 90 mm Hg or lower .


CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater .


The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater .


The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival .


A total of 192 patients were randomized ( 97 CR and 95 SR ) .


The CR and SR groups were similar at baseline .


The mean ( SD ) crystalloid volume administered during the study period was 1.0 L ( 1.5 ) in the CR group and 2.0 L ( 1.4 ) in the SR group , a difference of 1.0 L ( 95 % confidence interval [ CI ] , 0.6-1 .4 ) .


Intensive care unit-free days , ventilator-free days , renal injury , and renal failure did not differ between the groups .


At 24 hours after admission , there were 5 deaths ( 5 % ) in the CR group and 14 ( 15 % ) in the SR group ( adjusted odds ratio , 0.39 ; 95 % CI , 0.12-1 .26 ) .


Among patients with blunt trauma , 24-hour mortality was 3 % ( CR ) and 18 % ( SR ) with an adjusted odds ratio of 0.17 ( 0.03-0 .92 ) .


There was no difference among patients with penetrating trauma ( 9 % vs. 9 % ; adjusted odds ratio , 1.93 ; 95 % CI , 0.19-19 .17 ) .


CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma .


A large-scale , Phase III trial to examine its effects on survival and other clinical outcomes is warranted .


Therapeutic study , level I.


Early and intensive blood pressure-lowering treatment seems to be beneficial in patients with acute hemorrhagic stroke and high blood pressure .


We wanted to see if similar benefits can be shown from a later and more gradual blood pressure lowering , using data from the Scandinavian Candesartan Acute Stroke Trial ( SCAST ) .


SCAST was a randomized - and placebo-controlled , double-masked trial of candesartan given for 7 days , in 2029 patients with acute stroke and systolic blood pressure 140 mm Hg .


We assessed the effects of candesartan in the 274 patients with hemorrhagic stroke , using the trial 's 2 coprimary effect variables : the composite vascular end point of vascular death , stroke or myocardial infarction , and functional outcome at 6 months , according to the modified Rankin Scale .


We used Cox proportional hazards models and ordinal regression for analysis and adjusted for key , predefined prognostic variables .


There was no association between treatment with candesartan and risk of vascular events ( 17 of 144 [ 11.8 % ] versus 13 of 130 [ 10.0 % ] ; hazard ratio , 1.36 ; 95 % confidence interval , 0.65-2 .83 ; P = 0.41 ) .


For functional outcome we found evidence of a negative effect of candesartan ( common odds ratio , 1.61 ; 95 % confidence interval , 1.03-2 .50 ; P = 0.036 ) .


There was no evidence that blood pressure-lowering treatment with candesartan is beneficial during the first week of hemorrhagic stroke .


Instead , there were signs that such treatment may be harmful , but this needs to be verified in larger studies .


http://www.clinicaltrials.gov .


Unique identifier : NCT00120003 .


The prognostic significance of long-term visit-to-visit blood pressure variability ( BPV ) has not yet been validated in `` real world '' hypertensive patients .


The aim of the current study is to explore the prognostic value of BPV on stroke in hypertensive patients .


This was a dynamic prospective cohort study based on electronic medical records in Shanghai , China .


Hypertensive patients ( N = 122,636 ) without history of stroke at baseline , were followed up from 2005 to 2011 .


The cohort comprised of 4522 stroke patients and 118,114 non-stroke patients during a mean follow-up duration of 48 months .


BPV was measured by standard deviation ( SD ) and the coefficient of variation ( CV ) of blood pressure .


The visit-to-visit variability of both systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) was independently associated with the occurrence of stroke [ SD : the hazard ratios ( 95 % confidence intervals ) of SBP and DBP were 1.042 ( 1.021 to 1.064 ) and 1.052 ( 1.040 to 1.065 ) ; CV : the hazard ratios ( 95 % confidence intervals ) of SBP and DBP were 1.183 ( 1.010 to 1.356 ) and 1.151 ( 1.005 to 1.317 ) , respectively ] .


The hazard ratio values increased along with an increase of the BPV levels of SBP and DBP .


The increment effect remained significant after controlling the blood pressure control status of subjects .


Increased BPV of both SBP and DBP , independent of the average blood pressure , is a predictor of stroke among community hypertensive patients in real-world clinical practice .


The risk of stroke increased along with increased BPV .


Stabilizing BPV might be a therapeutic target in hypertension .


Trichotillomania is a psychiatric condition characterized by the chronic pulling and plucking of one 's own hair .


Cognitive-behavioral therapy shows promise as a treatment for trichotillomania and might be preferable to pharmacotherapy .


However , there have been no randomized , controlled studies of the efficacy of group cognitive-behavioral therapy .


We evaluated 44 subjects , recruited from April 2009 to May 2010 , all of whom met DSM-IV criteria for a diagnosis of trichotillomania .


Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy ( control ) .


Treatment evaluation was non-blind and used self-report scales .


The primary outcome measure was the improvement of hair-plucking behavior as assessed by the Massachusetts General Hospital Hairpulling Scale .


Secondary measures included scores on the Beck Depression Inventory , the Beck Anxiety Inventory , and the Social Adjustment Scale-Self-Report .


Both groups showed significant posttreatment improvement in the scores from the Massachusetts General Hospital Hairpulling Scale ( F = 23.762 , P < .001 ) and the Beck Depression Inventory ( F = 6.579 , P = .003 ) .


The decrease in hair-plucking behavior over time was significantly greater in the study group than in the control group ( F = 3.545 , P < .038 ) .


There were no significant differences between the pretreatment and posttreatment time points or between the groups in the scores from the Beck Anxiety Inventory and the Social Adjustment Scale-Self-Report .


We conclude that group cognitive-behavioral therapy is a valid treatment for trichotillomania .


This treatment model should be further revised and expanded to address comorbidities such as anxiety and social maladjustment .


ClinicalTrials.gov identifier : NCT01968343 .


Longitudinal data on bone mineral density ( BMD ) in children and adolescents with Prader-Willi Syndrome ( PWS ) during long-term GH treatment are not available .


This study aimed to determine effects of long-term GH treatment and puberty on BMD of total body ( BMDTB ) , lumbar spine ( BMDLS ) , and bone mineral apparent density of the lumbar spine ( BMADLS ) in children with PWS .


This was a prospective longitudinal study of a Dutch PWS cohort .


Seventy-seven children with PWS who remained prepubertal during GH treatment for 4 years and 64 children with PWS who received GH treatment for 9 years participated in the study .


The children received GH treatment , 1 mg/m ( 2 ) / day ( 0.035 mg/kg/d ) .


BMDTB , BMDLS , and BMADLS was measured by using the same dual-energy x-ray absorptiometry machine for all annual measurements .


In the prepubertal group , BMDTB standard deviation score ( SDS ) and BMDLSSDS significantly increased during 4 years of GH treatment whereas BMADLSSDS remained stable .


During adolescence , BMDTBSDS and BMADLSSDS decreased significantly , in girls from the age of 11 years and in boys from the ages of 14 and 16 years , respectively , but all BMD parameters remained within the normal range .


Higher Tanner stages tended to be associated with lower BMDTBSDS ( P = .083 ) and a significantly lower BMADLSSDS ( P = .016 ) .


After 9 years of GH treatment , lean body mass SDS was the most powerful predictor of BMDTBSDS and BMDLSSDS in adolescents with PWS .


This long-term GH study demonstrates that BMDTB , BMDLS , and BMADLS remain stable in prepubertal children with PWS but decreases during adolescence , parallel to incomplete pubertal development .


Based on our findings , clinicians should start sex hormone therapy from the age of 11 years in girls and 14 years in boys unless there is a normal progression of puberty .


To examine disordered eating and associations with health-related quality of life ( HRQOL ) in rural overweight/obese ( OW/OB ) children .


Cross-sectional analyses were conducted with 272 rural OW/OB children aged 8-12 years ( M = 10.36 ; SD = 1.39 ) .


Child anthropometrics , demographics , disordered eating attitudes , unhealthy weight control behaviors ( UWCBs ) , and HRQOL were measured .


Relationships between these variables were analyzed using bootstrapped multiple linear regressions .


Clinically significant disordered eating attitudes were endorsed by 17 % of the sample , and the majority endorsed UWCBs .


Disordered eating attitudes and weight status were the most common predictors of HRQOL .


Disordered eating attitudes and UWCBs were negatively related to emotional HRQOL but were unrelated to social , school , or physical HRQOL .


Disordered eating is a serious and relevant problem in OW/OB children living in rural areas and may be indicative of impairments in emotional functioning .


Early intervention may reduce the risk for eating disorders and associated negative sequelae .


From 2002 to 2007 , the International Berlin-Frankfurt-Mnster Study Group conducted a prospective randomized clinical trial ( ALL IC-BFM 2002 ) for the management of childhood acute lymphoblastic leukemia ( ALL ) in 15 countries on three continents .


The aim of this trial was to explore the impact of differential delayed intensification ( DI ) on outcome in all risk groups .


For this trial , 5,060 eligible patients were divided into three risk groups according to age , WBC , early treatment response , and unfavorable genetic aberrations .


DI was randomized as follows : standard risk ( SR ) , two 4-week intensive elements ( protocol III ) versus one 7-week protocol II ; intermediate risk ( IR ) , protocol III 3 versus protocol II 1 ; high risk ( HR ) , protocol III 3 versus either protocol II 2 ( Associazione Italiana Ematologia Oncologia Pediatrica [ AIEOP ] option ) , or 3 HR blocks plus single protocol II ( Berlin-Frankfurt-Mnster [ BFM ] option ) .


At 5 years , the probabilities of event-free survival and survival were 74 % ( 1 % ) and 82 % ( 1 % ) for all 5,060 eligible patients , 81 % and 90 % for the SR ( n = 1,564 ) , 75 % and 83 % for the IR ( n = 2,650 ) , and 55 % and 62 % for the HR ( n = 846 ) groups , respectively .


No improvement was accomplished by more intense and/or prolonged DI .


The ALL IC-BFM 2002 trial is a good example of international collaboration in pediatric oncology .


A wide platform of countries able to run randomized studies in ALL has been established .


Although the alternative DI did not improve outcome compared with standard treatment and the overall results are worse than those achieved by longer established leukemia groups , the national results have generally improved .


To evaluate the efficacy and safety of azithromycinfor treatment of uncomplicated pediatric scrub typhus .


A randomized controlled trial was performed .


We compared azithromycin with doxycycline or chloramphenicol in uncomplicated pediatric scrub typhus from inpatient pediatric department of Chiangrai Prachanukroh Hospital .


The primary outcome was cure rate at day 3 .


The secondary outcomes were timing to defervescence within 72 hours , side effects , and relapsed rate .


We compared data between both groups with Fisher 's exact test or Mann-Whitney U test , and failure rate was demonstrated by Kaplan-Meier survival curve and Log-rank test .


We included 57 patients , ofwhom , 28 were assigned to doxycycline or chloramphenicol ( control group ) and 29 to azithromycin ( study group ) .


The baseline characteristics of both groups were similar The cure rate was 85.7 % in the doxycycline or chloramphenicol group , as compared to 79.3 % in the azithromycin group ( p = 0.73 ) , and a median time to defervescence was 30 hours ( IQR 21 , 48 ) vs. 36 hours ( IQR 20 , 68 ) respectively ( p = 0.166 ) .


There was a little minor side effect in azithromycin group .


No relapsed was found in either groups .


Azithromycin was as effective as doxycycline or chloramphenicol in treatment of uncomplicated pediatric scrub typhus .


Obesity in youth remains a major public health issue .


Yet no effective long-term preventive strategy exists .


We previously showed that a school-based socio-ecological approach targeting behavior and social/environmental influences on physical activity ( PA ) prevented 4-year excessive weight gain in 12-year olds .


In this study , we investigated if this efficacy persists 30 months after intervention cessation .


The program targeted students , family , school and the living environment to promote/support PA and prevent sedentary behavior ( SB ) .


A total of 732 students from eight randomized middle schools completed the 4-year trial .


At the 30-month post-trial follow-up , body mass index ( BMI ) , fat mass index ( FMI ) , leisure PA ( LPA ) , home/school/workplace active commuting , TV/video time ( TVT ) , and attitudes toward PA were measured in 531 adolescents .


The beneficial effects of the intervention on the excess BMI increase ( +0.01 vs +0.34 kgm ( -2 ) in the intervention and control groups , respectively ) and on the overweight incidence in initially non-overweight students ( 4.3 % vs 8.6 % ; odds ratio = 0.48 ( 95 % confidence interval : 0.23-1 .01 ) ) were maintained at the post-trial follow-up .


LPA was not maintained at the level achieved during the trial .


However , we still observed a prevention of the age-related decrease of the adolescents ' percentage reporting regular LPA ( -14.4 % vs -26.5 % ) and a higher intention to exercise in the intervention group .


The intervention promoted lower TVT ( -14.0 vs +13.6 min per day ) and higher active commuting changes ( +11.7 % vs -4.8 % ) .


Trends in higher BMI reduction in students with high initial TVT and in the least wealthy group were noted .


TVT changes throughout the follow-up predicted excess BMI and FMI changes .


Long-term multilevel approach targeting PA and SB prevents excessive weight gain up to 30 months after intervention cessation .


The efficacy may be higher in the most sedentary and least wealthy adolescents .


Healthy PA-related behavior inducing long-lasting weight effects can be promoted in youth providing that an ecological approach is introduced in the prevention strategy .


Adolescents with chronic disease ( ACD ) must develop independent disease self-management and learn to communicate effectively with their health care team to transition from pediatric to adult-oriented health care systems .


Disease-specific interventions have been implemented to aid specific ACD groups through transition .


A generic approach might be effective and cost-saving .


Eighty-one ACD , aged 12 to 20 years , were recruited for a randomized clinical trial evaluating an 8-month transition intervention ( MD2Me ) .


MD2Me recipients received a 2-month intensive Web-based and text-delivered disease management and skill-based intervention followed by a 6-month review period .


MD2Me recipients also had access to a texting algorithm for disease assessment and health care team contact .


The intervention was applicable to adolescents with diverse chronic illnesses .


Controls received mailed materials on general health topics .


Disease management , health-related self-efficacy , and health assessments were performed at baseline and at 2 and 8 months .


Frequency of patient-initiated communications was recorded over the study period .


Outcomes were analyzed according to assigned treatment group over time .


MD2Me recipients demonstrated significant improvements in performance of disease management tasks , health-related self-efficacy , and patient-initiated communications compared with controls .


Outcomes in ACD improved significantly among recipients of a generic , technology-based intervention .


Technology can deliver transition interventions to adolescents with diverse chronic illnesses , and a generic approach offers a cost-effective means of positively influencing transition outcomes .


Further research is needed to determine whether improved short-term outcomes translate into an improved transition for ACD .


NK cells have anti-HIV activity mediated through killer cell immunoglobulin-like receptors ( KIRs ) .


The current prospective cohort study evaluated whether variation in KIR genes is associated with HIV infection in discordant couples ( DCs ) , where one spouse remains seronegative ( HSN ) despite repeated exposure to the HIV .


KIR was genotyped using PCR SSP .


Viral load and CD4 counts were estimated using commercially available reagents .


Data were analyzed using SPSS software .


Among the 47 DCs , HSN spouses had significantly ( P = 0.006 ) higher frequencies of KIR3DS1 .


Regression analysis revealed significant ( P = 0.009 ) association of KIR2DS1 with low viral load .


KIR2DS4 variant was associated ( P = 0.032 ) with high viral load .


Three pairs of KIR genes were in strong LD in HSNs and two pairs in HSPs .


There were 60 KIR genotypes , and 16 are reported the first time in the Indian population .


Exclusive genotypes were present either in HSPs ( N = 22 , 11 unique genotypes ) or in HSNs ( n = 27 , 9 unique genotypes ) .


This study highlights for the first time in the Indian population an association of KIR genes in HIV infection where presence of exclusive and unique genotypes indicates possible association with either HIV infection or with protection .


Allergic rhinitis ( AR ) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge , itching , sneezing , and congestion .


Ocular symptoms are commonly associated with AR and include itching or burning , tearing or watering , and redness .


Intranasal corticosteroids are a mainstay of treatment , and their effect on nasal symptoms is well described .


To demonstrate that a 14-day course of 200 g/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR .


This was a randomized , double-blind , parallel group , multicenter study comparing 200 g/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis .


The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score ( rTOSS ) .


Key secondary end points included mean change from baseline in the morning and evening rTOSS , end-of-treatment assessment of response , and effect on activities of daily living .


The primary analysis was performed using analysis of covariance with a linear fixed-effects model .


Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo .


The least squares mean difference in the change from baseline of rTOSS was -0.36 ( P = .002 ) .


A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS .


Significantly more patients taking fluticasone achieved an overall response compared with placebo .


Fluticasone had a significantly greater effect on daily living activities and was well tolerated .


This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR .


clinicaltrials.gov Identifier : NCT01817790 .


The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units ( Checklist - ICU ) trial is a pragmatic , two-arm , cluster-randomised trial involving 118 intensive care units in Brazil , with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist , definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality .


To describe our trial statistical analysis plan ( SAP ) .


This is an ongoing trial conducted in two phases .


In the preparatory observational phase , we collect three sets of baseline data : ICU characteristics ; patient characteristics , processes of care and outcomes ; and completed safety attitudes questionnaires ( SAQs ) .


In the randomised phase , ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ .


Our SAP includes the prespecified model for the primary and secondary outcome analyses , which account for the cluster-randomised design and availability of baseline data .


We also detail the multiple mediation models that we will use to assess our secondary hypothesis ( that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist , but also through changes in safety culture ) .


We describe our approach to sensitivity and subgroup analyses and missing data .


We report our SAP before closing our study database and starting analysis .


We anticipate that this should prevent analysis bias and enhance the utility of results .


The aim of this study is to investigate if therapeutic weight loss reduces P wave dispersion .


20 obese patients ( 10 males and 10 females ) , part of a randomized clinical trial , were examined over a 6 month period .


They were treated with a diet , aiming at 5 % weight loss at the 6th month .


After physical examination , they underwent laboratory tests , bioelectrical impedance analysis and a electrocardiogram ( ECG ) .


ECGs were transferred to a personal computer via a scanner and then magnified 400 times .


We examined at baseline and at the 6th month , maximum and minimum P-wave duration , P-wave dispersion and heart rate .


Comparing responders ( patients who lost 5 % of weight at t6 ) and not responders ( who lost less than 5 % ) , responders showed a significant reduction of P wave dispersion value ( -0.38 [ SD : 0.35 ] mm equal to -32.3 [ SD : 11.3 ] % p = 0.00001 ) .


All responders present a reduction of P wave dispersion , while for not-responders this is no longer evident .


Finally , a good degree of correlation ( r = 0.54 ) between P wave dispersion difference and the decrease of weight was noticed .


Females have a better response in P dispersion reduction strictly connected with their weight loss with a good correlation , ( r = 0.7 , p = 0.002 ) , versus a moderate correlation evidenced in males ( r = 0.5 , p = 0.011 ) .


P wave duration and dispersion are significantly reduced in patients who lost more than 5 % of weight and this decrease is highly related to the extent of weight loss .


To evaluate the efficacy and safety of iron protein succinylate ( IPS ) oral solution in preventing and treating anemia of prematurity ( AOP ) .


Sixty premature infants less than 35 weeks of gestation were randomly divided into IPS ( n = 30 ) and polysaccharide iron complex ( PIC ) groups ( n = 30 ) .


Treatment began at two weeks after birth .


The infants received IPS or PIC in addition to recombinant human erythropoietin .


On days 14 , 28 , 42 , and 60 after treatment , hemoglobin ( Hb ) , red blood cell count ( RBC ) , hematocrit ( HCT ) , percentage of reticulocytes , serum iron , and serum ferritin were determined .


Liver and renal functions were evaluated before and after treatment .


There were significant differences in the changing trends of RBC and HCT between the two groups ( P < 0.05 ) .


In the IPS group , RBC and HCT gradually decreased after birth , but began to rise gradually on days 28 and 42 of treatment ; in the PIC group , RBC and HCT kept decreasing from birth to day 60 of treatment .


On day 60 of treatment , the IPS group had significantly higher levels of Hb , RBC , HCT , serum iron , and serum ferritin than the PIC group ( P < 0.05 ) .


No notable adverse events occurred in either group .


IPS oral solution has good efficacy and tolerability in preventing and treating AOP .


To compare the features of capsulotomy obtained during femtosecond laser-assisted cataract surgery with those of continuous curvilinear capsulorhexis ( CCC ) obtained using a standard manual technique .


Ophthalmology Clinic , Department of Medicine and Science of Ageing , University G. D'Annunzio Chieti-Pescara , Chieti , Italy .


Prospective randomized clinical study .


Candidates for cataract extraction were randomized into 1 of 3 groups as follows : Lensx femtosecond laser-assisted cataract surgery capsulotomy ( laser group 1 ) , Lensar femtosecond laser-assisted cataract surgery capsulotomy ( laser group 2 ) , and manual CCC ( manual group ) .


Each group comprised 30 eyes ( 30 patients ) .


The capsulotomies in laser group 1 and laser group 2 showed significantly better circularity than the manual CCCs at 7 days ( P < .001 ) .


There was a significant correlation between the intended versus achieved capsulotomy size in the 2 laser groups .


Both laser groups had better intraocular lens ( IOL ) centration than the manual group at all timepoints ( P < .001 ) .


Between-group differences in uncorrected and corrected distance visual acuities were not statistically significant .


The residual spherical equivalent and mean absolute error were statistically significantly smaller in the 2 laser groups than in the manual group ( P = .038 ) and increased significantly over time in all the groups ( P < .001 ) .


Femtosecond laser capsulotomies showed better circularity with more predictable size than manual CCCs .


In addition , IOL centration was better immediately after surgery and over time with better refractive results in the 2 laser groups .


To evaluate the effect of automated tube voltage selection on radiation dose and image quality at cardiovascular CT angiography ( CTA ) .


We retrospectively analysed paired studies in 72 patients ( 41 male , 60.516.5 years ) , who had undergone CTA acquisitions of the heart or aorta both before and after the implementation of an automated x-ray tube voltage selection algorithm ( ATVS ) .


All other parameters were kept identical between the two acquisitions .


Subjective image quality ( IQ ) was rated and objective IQ was measured by image noise , signal-to-noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) and figure of merit ( FOM ) .


Image quality parameters and effective dose were compared between acquisitions .


Overall subjective image quality improved with the percentage of cases scored as adequate or higher increasing from 79 % to 92 % after implementation of ATVS ( P = 0.03 ) .


SNR ( 14.15.9 , 15.76.1 , P = 0.009 ) , CNR ( 11.65.3 , 13.25.6 , P = 0.011 ) , and FOM ( 19.923.3 , 43.851.1 , P < 0.001 ) were significantly higher after implementation of ATVS .


Mean image noise ( 24.18.4 HU , 22.77.1 HU , P = 0.048 ) and mean effective dose ( 10.65.9 mSv , 8.85.0 mSv , P = 0.003 ) were significantly lower after implementation of ATVS .


Automated tube voltage selection can operator-independently optimize cardiovascular CTA image acquisition parameters with improved image quality at reduced dose .


Automatic tube voltage selection optimizes tube voltage for each individual patient .


In this population , overall radiation dose decreased while image quality improved .


This tool may become valuable for improving dose/quality ratio .


Inhaled corticosteroids ( ICSs ) are widely used in asthma control .


Ciclesonide ( CIC ) is an ICS with on-site lung activation for potent anti-inflammatory activity .


This study aimed to compare the clinical benefit of CIC with budesonide ( BUD ) in step-down therapy .


A total of 150 patients with mild-to-moderate asthma well controlled by a combination of ICS and long-acting 2-agonist were randomised to receive either CIC 320g ( n = 75 ) once daily or 2 inhalations of BUD 200g ( n = 75 ) twice daily for 12 weeks .


The forced expiratory volume in 1s ( FEV1 ) , maximum mid-expiratory flow ( MMEF ) and asthma control test ( ACT ) scores were measured .


Ranked stratification of patients and physicians was assessed .


Drug adherence was significantly higher in the CIC group than in the BUD group ( 76.0 % vs. 58.7 % , P = 0.03 ) .


The FEV1 and MMEF remained stable throughout the 12-week CIC treatment .


In the BUD group , FEV1 significantly decreased at weeks 4 and 12 .


MMEF had a higher value in the CIC group than in the BUD group .


Both patients and physicians ranked CIC over BUD .


CIC is more effective and has better drug adherence than BUD as step-down treatment when asthma is well controlled by combination therapy .


The efficacy of psychodynamic therapy ( PDT ) for depression is debated due to a paucity of high-quality studies .


We compared short psychodynamic supportive psychotherapy ( SPSP ) to cognitive behavioral therapy ( CBT ) in a randomized clinical trial .


We used therapist-rated outcomes to examine how the course of change during treatment could be best represented and to compare treatment efficacy , hypothesizing non-significant differences .


Three hundred and forty-one adults meeting DSM-IV criteria for a depressive episode and with Hamilton Depression Rating Scale ( HAM-D ) scores 14 were randomized to 16 sessions of individual manualized CBT or SPSP .


Severely depressed patients ( HAM-D > 24 ) received additional antidepressant medication .


After each session , therapists rated the Clinical Global Impression Scale subscales ` Severity of Illness ' ( CGI-S ) and ` Global Improvement ' ( CGI-I ) , and the DSM-IV Axis V Global Assessment of Functioning Scale ( GAF ) .


We fitted growth curves using mixed model analyses with intention-to-treat samples .


CGI-S and GAF scores during treatment were best represented by a linear symptom decrease .


CGI-I scores were best represented by an S-shaped curve with relative more improvement in the first and last phases than in the middle phase of treatment .


No significant post-treatment treatment differences were found .


A non-significant trend for a treatment effect on CGI-S scores vanished when controlling for therapist gender and profession .


Therapists were not specifically trained for CGI and GAF assessments .


These findings add to the evidence-base of PDT for depression .


Therapist characteristics and differences between severity and improvement measures might influence ratings and need to be taken into account when using therapist-rated outcome measures .


To compare asthma control assessment using the Asthma APGAR system , a tool developed by primary care clinicians , in a multicenter primary care sample with the Asthma Control Test ( ACT ) / Childhood Asthma Control Test ( CACT ) , a tool developed by asthma specialists .


This is a substudy of a multicenter , randomized , controlled pragmatic trial that tests the effectiveness of the Asthma APGAR system in primary care practices .


As part of the study , enrolled patients completed both the ACT/CACT and the Asthma APGAR system between March 1 , 2011 , and December 31 , 2011 .


Kappa and McNemar statistics were used to compare the results of questionnaires .


Of the 468 patients in our sample , 306 ( 65 % ) were classified as not controlled by the ACT/CACT or the Asthma APGAR system .


The overall agreement was 84.4 % , with a kappa value of .68 ( substantial agreement ) and a McNemar test P value of .35 ( suggesting no significant difference in the direction of disagreement ) .


Of those with poor control as defined by the Asthma APGAR system , 23.8 % ( 73 ) had no controller medications and 76.5 % ( 234 ) were seldom or sometimes able to avoid identified triggers for their asthma .


Of those who stated that they had been prescribed controller medications , 116 of 332 ( 35 % ) stated that they did not use the controller medication on a daily basis .


The Asthma APGAR system and the ACT/CACT similarly assess asthma control in a multicenter primary care-based sample .


The Asthma APGAR system identified an `` actionable item '' in more than 75 % ( 234 ) of the individuals with poor asthma control , thus linking an assessment of poor asthma control with a management strategy .


To evaluate the applicability of magnetic resonance imaging ( MRI ) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment .


Prospective , randomized , controlled , double-blind study .


One single tertiary care institution in a large , cosmopolitan city .


Twenty-six patients ( n = 42 ears ) with clinical , audiometric , and tomographic diagnosis of otosclerosis were enrolled .


If computed tomography ( CT ) demonstrated active lesions , these patients underwent MRI to detect otospongiotic foci , seen as areas of gadolinium enhancement .


Patients were divided into 3 groups and received treatment with placebo , sodium alendronate , or sodium fluoride for 6 months .


After this period , clinical and audiometric evaluations and a second MRI were performed .


Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective ( visual ) and objective ( using specific eFilm Workstation software ) manner .


Otospongiosis was most predominantly identified in the region anterior to the oval window , and this site was reliable for comparing pre - and posttreatment scans .


The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions , more relevant in the alendronate group .


These findings were statistically significant for both subjective and objective MRI evaluations .


MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis .


The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis .


The PLATINUM randomized trial enrolled 1530 patients treated with either the platinum chromium PROMUS Element everolimus-eluting stent ( PtCr-EES ; Boston Scientific , Natick , MA , USA ) or the predicate cobalt chromium PROMUS/XIENCE V EES ( CoCr-EES ; manufactured as XIENCE V by Abbott Vascular , Santa Clara , CA , USA also distributed as PROMUS by Boston Scientific ) , including 124 patients from Japanese sites .


This substudy examines 2-year outcomes in the Japanese and non-Japanese cohorts .


Patients with 1 or 2 de novo native coronary artery lesions ( baseline vessel diameter 2.50 mm to 4.25 mm and length 24mm ) were randomized 1:1 to PtCr-EES ( N = 63 patients in Japan ) versus CoCr-EES ( N = 61 patients in Japan ) .


Several significant differences were noted in baseline demographics , lesion characteristics , and procedural technique between Japanese and non-Japanese patients , including longer fluoroscopy time , less use of contrast , and greater post-dilatation usage and maximum pressure in Japan .


Dual antiplatelet usage at 2 years was also higher in Japan .


Despite these differences , the 2-year rates of target lesion failure were comparable in patients treated with PtCr-EES and CoCr-EES both in Japan ( 3.2 % vs 5.0 % respectively , p = 0.68 ) and outside Japan ( 4.7 % vs 5.9 % respectively , p = 0.33 ; p for interaction = 0.82 ) .


This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients .


Postoperative sore throat ( POST ) is a frequent consequence following ETT intubation , which may negatively affect the postoperative course and patient satisfaction .


Benzydamine hydrochloride is a topically-applied non-steroidal anti-inflammatory drug ( NSAID ) .


The authors evaluated the analgesic effect of benzydamine hydrochloride dripping on the ETT cuff on POST .


Eighty-six patients participated in this randomized controlled trial .


They were assigned into either the benzydamine hydrochloride or the control group .


The whole ETT cuff was dripped either with 3 ml ( 4.5 mg ) of benzydamine hydrochloride or nothing five minutes prior to anesthesia induction .


The incidence and severity of POST at 0 , 2 , 4 , 6 , 12 and 24 hours postoperatively were assessed .


The potential adverse effects of benzydamine hydrochloride ( throat numbness throat burning sensation , dry mouth , and thirst ) were also evaluated .


Twenty-five patients ( 58.14 % ) in each group had POST ( p-value = 1 ) .


The severity of POST ( calculated from affected patients ) in both groups at different time points was not significantly different .


Patients in the benzydamine hydrochloride group did not have a higher incidence of adverse effects .


We found that dripping benzydamine hydrochloride on the ETT cuff neither reduced the incidence of POST nor increased the incidence of adverse effects in comparison with no intervention .


Inflammatory bowel diseases impose on patients a broad spectrum of somatic and psychosocial burden .


We hypothesized that patients ' self-responsibility in planning and initiating adequate usually multimodal health care can be supported by self-assessment and proactive information , thus improving health-related quality of life and social participation .


We conducted a randomized controlled trial among a random sample of adult members of a German statutory health insurance with Crohn 's disease or ulcerative colitis with at least 1 inflammatory bowel diseases-related hospital stay or sick leave in 2009 or 2010 .


Five hundred fourteen patients completed a postal screening questionnaire inquiring about 22 problems .


The intervention group ( IG ) received an automated data analysis with individualized written advice on appropriate health services , and the control group received usual care .


Main outcomes were health-related quality of life and social participation .


Secondary outcomes included health care utilization , number of screened problems , and self-management skills .


After 12 months , small beneficial effects were seen for all primary outcomes in the IG : EuroQol visual analog scale score ( difference between IG and control group : 4.4 ; 95 % confidence interval , 7.7-1 .0 ; P = 0.011 ) , index for measuring participation restriction ( IMET ) score ( difference between IG and control group : 0.4 ; 95 % confidence interval , 0.07-0 .62 ; P = 0.013 ) .


The number of disability days improved only in the IG .


The IG reported significantly fewer outpatient visits , fewer disease-related problems , and improved self-management skills ( health education impact questionnaire scores ) with no increase in disease activity , hospital stays , or consultations with allied health professionals .


Our activation and information procedure is effective and beneficial .


Further studies might show its usefulness in comprehensive management of patients with inflammatory bowel diseases .


To investigate the significance of dynamic monitoring of procalcitonin ( PCT ) in guiding the use of antibiotics for treating patients with sepsis in intensive care unit ( ICU ) .


Eighty-two patients with sepsis from January 2012 to June 2013 hospitalized in ICU of First Hospital of Jilin University were enrolled , and they were randomly divided into regular antibiotic therapy group ( RAT group , n = 40 ) and PCT monitoring in guiding the use of antibiotics group ( PCT group , n = 42 ) .


Patients in RAT group were treated according to principle of antibiotics usage , while in PCT group patients ' PCT value was observed everyday .


When no active symptoms of infection were shown , and acute physiology and chronic health evaluation II ( APACHEII ) scores declined , PCT value decreased over 90 % or PCT value lower than 0.25 g/L time point were selected as drug withdrawal indication .


The general status of the patient , antimicrobial drug use time , and prognosis were compared between the two groups , and Kaplan-Meier method was used for survival curve analysis .


Variance analysis was used for repeating measurement to observe dynamic serum PCT level of the two groups of patients for survival and death during 7 days .


Mann-Whitney U test or ( 2 ) test showed that there were no statistical significance in age , gender , APACHEII score , blood culture positive rate , sputum culture positive rate , cardiac insufficiency , renal failure , respiratory failure , and ventilator and hemofiltration usage ( all P > 0.05 ) .


Log Rank test results showed that the time of antimicrobial drug usage was significantly reduced in PCT group than that in RAT group [ days : 8.10.3 , 95 % confidence interval ( 95 % CI 8.3-9 .7 ) vs. 9.30.3 ( 95 % CI 8.7-10 .1 ) , P = 0.013 ] .


Kaplan-Meier univariate survival curves showed that the speed of curve declination in PCT group was faster significantly than that in RAT group , suggesting that the time of using antimicrobial drug was shortened .


There was no significant difference in length of hospital stay , ICU stay time , number of death in 28 days , number of cases of recurrence in 28 days and clinical cure rate between two groups ( all P > 0.05 ) .


PCT level in non-survivors in both groups was significantly higher than that in the survivors , exceeding more than 10 g/L in the early and late stages of treatment .


Dynamic monitoring of PCT can effectively reduce antimicrobial drug use in ICU patients with sepsis , but there is no significant difference in patients ' prognosis .


The PDY6797 study evaluated efficacy , safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus ( T2DM ) insufficiently controlled with sulphonylureas with/without metformin .


This randomized , double-blind , placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10g , and a 5 - to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30g once ( QD ) or twice daily ( BID ) .


The primary endpoint was change in postprandial plasma glucose ( PPG ) area under the curve ( AUC ) [ 0:29 -4:30 h ] after a standardized breakfast at the highest tolerated lixisenatide dose .


Change from baseline in glycated haemoglobin ( HbA1c ) , 2-h PPG and fasting plasma glucose ( FPG ) were assessed , as were adverse events .


Change from baseline in PPG AUC [ 0:29 -4:30 h ] with lixisenatide QD and BID was significantly greater than placebo ( p < 0.0001 for all study populations ) , with particularly prominent effects in Japanese patients .


Greater reductions in PPG AUC [ 0:29 -4:30 h ] were seen with lixisenatide QD versus BID , while the totality of evidence suggested that the lixisenatide 20g dose was optimal .


In the overall population , changes from baseline for 2-h PPG , HbA1c and FPG were significant with lixisenatide QD and BID versus placebo ( p < 0.01 for all ) .


Lixisenatide was well tolerated .


Lixisenatide significantly reduced PPG AUC [ 0:29 -4:30 h ] versus placebo at the highest well-tolerated dose in patients with T2DM treated with sulphonylureas with/without metformin and had a good safety and tolerability profile .


Japanese patients experienced particular benefits with lixisenatide in terms of reductions in PPG excursions .


Relatively low radioiodine uptake ( RAIU ) represents a common obstacle for radioiodine ( ( 131 ) I ) therapy in patients with multinodular goiter complicated by hyperthyroidism .


To evaluate whether thiamazole ( MTZ ) pretreatment can increase ( 131 ) I therapeutic efficacy .


Twenty-two patients with multinodular goiter , subclinical hyperthyroidism , and RAIU < 50 % were randomized to receive either a low-iodine diet ( LID ; n = 10 ) or MTZ 30 mg/d ( n = 12 ) for 42 days .


Thyroid function and 24-hour RAIU were measured before and after treatment .


Thyroid volume was evaluated by either magnetic resonance imaging or single photon emission computed tomography .


Mean 24-hour RAIU increased significantly from 32 10 % to 63 18 % in the MTZ group ( P < .001 ) .


Consequently , there was a 31 % decrease in the calculated median therapeutic ( 131 ) I activity after MTZ ( P < .05 ) .


No significant changes in 24-hour RAIU were observed after diet .


In the MTZ group , median serum TSH levels increased significantly by 9 % and mean serum free T4 and free T3 concentrations decreased by 22 % and 15 % , respectively , whereas no changes in thyroid function were observed in the LID group .


Thyroid volume did not significantly change in either of the two groups .


At 12 months after radioiodine treatment , median serum TSH was within the normal range in both groups .


MTZ treatment before ( 131 ) I therapy resulted in an average 2-fold increase in thyroid RAIU and enhanced the efficiency of radioiodine therapy assessed at 12 months .


MTZ pretreatment is therefore a safe , easily accessible alternative to recombinant human TSH stimulation and a more effective option than LID .


To evaluate pregnancy rates based on the route of progesterone replacement in frozen embryo transfer ( FET ) cycles .


A randomized controlled trial and retrospective analysis .


In the randomized group 76 FET cycles were randomized .


In the retrospective group 508 FET cycles were reviewed .


Intramuscular ( IM ) proges-erone in oil 100 mg daily or oral micronized progesterone prior to transfer followed by compounded vaginal proges-erone 200 mg 3 times daily ( OV ) .


The main outcome measure was the clinical pregnancy rate ( CPR ) .


Baseline characteristics did not vary be-ween groups in either cohort .


In the randomized group there were no significant differences in CPR ( 31.43 % vs. 21.05 % ) or live birth rate ( LBR ) ( 31.43 % vs. 18.92 % ) for IM and OV progesterone replacement , respectively .


In the retrospective cohort patients there wore also no significant differences in CPR ( 35.56 % vs. 32.35 % ) or LBR ( 32.23 % vs. 28.51 % ) f or the IM and OVp rogester-ne replacement groups , respectively .


This study demonstrates that either OV or IM progesterone is effective for luteal phase support for FETs .


Surgically assisted rapid palatal expansion ( SARPE ) is the procedure of choice for treatment of adults with transverse maxillary deficiency greater than 7 mm .


There is no consensus about the dentoskeletal effect of an orthodontic retainer on the outcome of SARPE .


Our objective was to assess the effectiveness of an orthodontic retainer on dentoskeletal stability .


Ninety digitized dental casts of 30 adults undergoing SARPE were divided into 2 groups-no retention ( n = 15 ) and retention ( n = 15 ) - and assessed .


The dental casts were obtained at 3 checkpoints : ( 1 ) 7 days on average before SARPE ( preoperatively ) , ( 2 ) 4 months after expansion , and ( 3 ) 10 months after expansion was completed .


The retention patients received a transpalatal arch just after expander removal , at checkpoint 2 .


The transpalatal arch was kept for 10 months after completion of the expansion ( checkpoint 3 and end of the study ) .


The dental casts were scanned with a Vivid 9i 3D laser scanner ( Konica Minolta , Wayne , NJ ) .


The distances measured were premolar and molar intercusp distances , premolar and molar intercervical distances , premolar and molar inter-WALA ( Will Andrews and Lawrence Andrews ) ridge distances , and palate height at the maxillary first molar .


The planned maxillary expansion was within the expected amount ( P < 0.05 ) .


Palatal height at the 4-month checkpoint decreased by 0.79 mm ( 4.38 % ) ( P < 0.001 ) and again at the 10-month checkpoint by 0.38 mm ( 0.98 % ) ( P > 0.05 ) but not significantly in both groups .


The premolar intercusp distance had a relapse at checkpoint 3 of 1.84 mm ( 7.18 % ) ( P < 0.001 ) in the no-retention group .


Both groups had average relapses of 0.95 mm in the premolar intercervical distances , of 0.88 mm in the premolar inter-WALA ridge distances , of 1.04 mm in the molar intercusp distances , of 0.74 mm in the molar intercervical distances , and of 0.84 mm in the molar inter-WALA ridge distances ( P < 0.05 ) at checkpoint 3 .


The analysis of relapse in both groups suggests that the use of a transpalatal arch as a retaining device does not improve dento-osseous stability .


Acellular dermal matrix ( ADM ) has been used for antiadhesion formation along with wound healing in various surgical fields .


The aim is to assess the efficacy of ADM implantation in the prevention of postoperative scars and adhesions after conventional , open , total thyroidectomy .


Forty-four patients with papillary thyroid carcinoma undergoing thyroidectomy were randomly assigned to the study ( ADM implantation ) or control group ( without ADM ) .


Global photographic assessment , Vancouver scar scale ( VSS ) , objective scar assessment , and swallowing impairment index were assessed at baseline , immediately after surgery , and at 1 and 2 months after surgery .


Nineteen control and 20 study group participants completed the study .


The mean VSS score of the study group was significantly lower than the controls at both 1 month ( 3.06 1.25 vs 4.41 1.54 , respectively ) and 2 months ( 2.76 1.56 vs 4.35 1.58 , respectively ) after surgery .


Scar quality measures ( mean melanin and erythema indexes ) were significantly lower in the study group compared with controls .


Study group participants had significantly lower swallowing impairment scores than controls .


The mean postoperative hospitalization of both groups was not significantly different .


Acellular dermal matrix-assisted implants appear to improve post-thyroidectomy scar and swallowing impairments without delays in operation time .


Heart failure with preserved ejection fraction ( HFpEF ) is associated with substantial morbidity and mortality .


Existing data on cardiac structure and function in HFpEF suggest significant heterogeneity in this population .


Echocardiograms were obtained from 935 patients with HFpEF ( left ventricular ejection fraction 45 % ) enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist ( TOPCAT ) trial before initiation of randomized therapy .


Average age was 7010 years , 49 % were women , 14 % were of African descent , and comorbidities were highly prevalent .


Centralized quantitative analysis in a blinded core laboratory demonstrated a mean left ventricular ejection fraction of 59.37.9 % , with prevalent concentric left ventricular remodeling ( 34 % ) and hypertrophy ( 43 % ) , and left atrial enlargement ( 53 % ) .


Diastolic dysfunction was present in 66 % of gradable participants and was significantly associated with greater left ventricular hypertrophy and a higher prevalence of left atrial enlargement .


Doppler evidence of pulmonary hypertension was present in 36 % .


At least 1 measure of structural heart disease was present in 93 % of patients .


Patients enrolled in TOPCAT demonstrated heterogeneous patterns of ventricular remodeling , with high prevalence of structural heart disease , including left ventricular hypertrophy and left atrial enlargement , in addition to pulmonary hypertension , each of which has been associated with adverse outcomes in HFpEF .


Diastolic function was normal in approximately one third of gradable participants , highlighting the heterogeneity of the cardiac phenotype in this syndrome .


These findings deepen our understanding of the TOPCAT trial population and expand our knowledge of the diversity of the cardiac phenotype in HFpEF .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00094302 .


This study examined the relationships between treatment fidelity and treatment outcomes in a community-based trial of a 12-Step Facilitation ( TSF ) intervention .


In a prior multi-site randomized clinical trial , 234 participants in 10 outpatient drug treatment clinics were assigned to receive the Stimulant Abuser Groups to Engage in 12-Step ( STAGE-12 ) intervention .


A secondary analysis reviewed and coded all STAGE-12 sessions for fidelity to the protocol , using the Twelve Step Facilitation Adherence Competence Empathy Scale ( TSF ACES ) .


Linear mixed-effects models tested the relationship between three fidelity measures ( adherence , competence , empathy ) and six treatment outcomes ( number of days of drug use and five Addiction Severity Index ( ASI ) composite scores ) measured at 3 months post-baseline .


Adherence , competence and empathy were robustly associated with improved employment status at follow up .


Empathy was inversely associated with drug use , as was competence in a non-significant trend ( p = .06 ) .


Testing individual ASI drug composite score items suggested that greater competence was associated with fewer days of drug use and , at the same time , with an increased sense of being troubled or bothered by drug use .


Greater competence and empathy in the delivery of a TSF intervention were associated with better drug use and employment outcomes , while adherence was associated with employment outcomes only .


Higher therapist competence was associated with lower self-report drug use , and also associated with greater self-report concern about drug use .


The nature of TSF intervention may promote high levels of concern about drug use even when actual use is low .


Clinical activity of chemotherapy plus trastuzumab in HER2 overexpressing advanced breast cancer has been documented .


We report the activity and safety results of biweekly combination of trastuzumab , docetaxel and gemcitabine as first-line therapy in HER2-positive advanced breast cancer .


Patients were biweekly treated with trastuzumab ( 4 mg/kg ) , gemcitabine ( 1000 mg/m ( 2 ) ) and docetaxel ( 50 mg/m ( 2 ) ) .


The primary end point was overall response rate , secondary time to progression , clinical benefit rate ( partial response plus complete response plus stable disease for 24 weeks ) and tolerability .


A total of 65 patients with HER2-positive advanced breast cancer have been enrolled .


In total , 47 patients responded ( 73 % ; 95 % CI , 60-84 ) , 11 achieved complete response ( 17 % ; 95 % CI : 8.9-28 .7 ) , 36 achieved partial response ( 56 % ; 95 % CI : 43-68 .6 ) .


The clinical benefit rate was 87.5 % ( 95 % CI : 77-94 ) .


Three patients ( 4.7 % ) experienced progressive disease .


The median time to progression was 14.2 months ( 95 % CI : 10.6-17 .8 ) , the median overall survival was 39.3 months and the 36-month survival rate was 55.5 % ( 95 % CI : 58-73 ) .


The worst toxicities were grade 3 neutropenia ( 12 % ) , thrombocytopenia ( 6 % ) and diarrhea ( 6 % ) .


No cardiac toxicity was reported .


As first-line therapy , this combination allowed the delivery of polychemotherapy in association to targeted therapy , with clinical activity and mild toxicity .


The promising results should be further explored in Phase III randomized clinical trials .


To assess whether in early ( rheumatoid ) arthritis ( RA ) patients , metacarpal bone mineral density ( BMD ) loss after 4months predicts radiological progression after 1year of antirheumatic treatment .


Metacarpal BMD was measured 4 monthly during the first year by digital X-ray radiogrammetry ( DXR-BMD ) in patients participating in the IMPROVED study , a clinical trial in 610 patients with recent onset RA ( 2010 criteria ) or undifferentiated arthritis , treated according to a remission ( disease activity score < 1.6 ) steered strategy .


With Sharp/van der Heijde progression 0.5 points after 1year ( yes/no ) as dependent variable , univariate and multivariate logistic regression analyses were performed .


Of 428 patients with DXR-BMD results and progression scores available , 28 ( 7 % ) had radiological progression after 1year .


Independent predictors for radiological progression were presence of baseline erosions ( OR ( 95 % CI ) 6.5 ( 1.7 to 25 ) ) and early DXR-BMD loss ( OR ( 95 % CI ) 1.5 ( 1.1 to 2.0 ) ) .


In 366 ( 86 % ) patients without baseline erosions , early DXR-BMD loss was the only independent predictor of progression ( OR ( 95 % CI ) 2.0 ( 1.4 to 2.9 ) ) .


In early RA patients , metacarpal BMD loss after 4months of treatment is an independent predictor of radiological progression after 1year .


In patients without baseline erosions , early metacarpal BMD loss is the main predictor of radiological progression .


To compare the effectiveness of two low-intensity approaches for distressed patients with cancer and caregivers who had called cancer helplines seeking support .


Baseline distress was hypothesized as a moderator of intervention effect .


Randomized trial .


Community-based cancer helplines in Queensland and New South Wales , Australia .


354 patients with cancer and 336 caregivers .


Participants were randomized to either a single session of nurse-led self-management intervention or a five-session psychologist cognitive behavioral intervention delivered by telephone .


Assessments were undertaken at baseline ( preintervention ) and at 3 , 6 , and 12 months .


Psychological and cancer-specific distress and post-traumatic growth .


No significant moderation by baseline cancer-specific distress was noted .


For low-education patients , only the psychologist intervention was associated with a significant drop in distress .


For all other participants , distress decreased over time in both arms with small to large effect sizes ( Cohen 's ds = 0.05-0 .82 ) .


Post-traumatic growth increased over time for all participants ( Cohen 's ds = 0.6-0 .64 ) .


Many distressed patients with cancer and their caregivers may benefit significantly from a single session of a nurse psychoeducation intervention that can be delivered remotely by telephone and supported by self-management materials .


Research is needed to develop an algorithm that moves beyond the use of distress as the only indicator for referral to specialist psychological services .


Survivors and caregivers with low education and low literacy may require more in-depth and targeted support .


Brief nurse psychoeducation and stress management for cancer survivors and caregivers should be considered as part of a tiered approach to psychosocial care .


To compare the effectiveness of controlled-released carbamazepine ( CR-CBZ ) to levetiracetam ( LEV ) and to lamotrigine ( LTG ) in elderly patients with newly diagnosed focal epilepsy .


Randomized , double-blind , parallel-group trial conducted between January 2007 and August 2011 , in 47 ambulatory or hospital sites in Germany , Austria , or Switzerland .


Eligible participants were aged 60 , had new-onset epilepsy , had no acute illness as the cause of their seizures , and had no contraindication to the drugs in the trial .


Patients were randomized 1:1:1 to CR-CBZ , LTG , or LEV .


Doses were up-titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks .


Primary outcome was the retention to treatment at week 58 ; secondary measures related to seizure and adverse event frequency .


Of 361 randomized patients , 359 were included ( CR-CBZ n = 121 , LTG n = 117 , LEV n = 122 ) in the modified intent-to-treat population ( mean age [ range ] 71.4 [ 60-95 ] years ) .


At week 58 , the retention rate for LEV was significantly higher than for CR-CBZ ( 61.5 % vs. 45.8 % , p = 0.02 ) , and similar to LTG ( 55.6 % ) .


Seizure freedom rates at weeks 30 and 58 were not different across the groups .


Twice as many patients receiving CR-CBZ discontinued due to adverse events or death compared to those in the LEV group ( 32.2 % vs. 17.2 % ; odds ratio 2.28 , 95 % confidence interval [ CI ] 1.25-4 .19 , p = 0.007 ) , whereas discontinuation was intermediate for LTG ( 26.3 % ) .


Median daily doses of completers ( n = 195 ) were CR-CBZ 380.0 mg/day ( 333.0-384 .0 ) , LTG 95 mg/day ( 94.0-97 .0 ) , and LEV 950 mg/day ( 940.0-985 .0 ) .


In the initial monotherapy of focal epilepsy in the elderly , 1-year retention to LEV was higher compared to CR-CBZ due to better tolerability .


Retention of LTG was intermediate and close to LEV , but did not differ significantly from either comparators .


NCT00438451 , www.clinicaltrials.gov .


To determine whether an evidence-based pediatric outpatient intervention for parents who smoke persisted after initial implementation .


A cluster randomized controlled trial of 20 pediatric practices in 16 states that received either Clinical and Community Effort Against Secondhand Smoke Exposure ( CEASE ) intervention or usual care .


The intervention provided practices with training to provide evidence-based assistance to parents who smoke .


The primary outcome , assessed by the 12-month follow-up telephone survey with parents , was provision of meaningful tobacco control assistance , defined as discussing various strategies to quit smoking , discussing smoking cessation medication , or recommending the use of the state quitline after initial enrollment visit .


We also assessed parental quit rates at 12 months , determined by self-report and biochemical verification .


Practices ' rates of providing any meaningful tobacco control assistance ( 55 % vs 19 % ) , discussing various strategies to quit smoking ( 25 % vs 10 % ) , discussing cessation medication ( 41 % vs 11 % ) , and recommending the use of the quitline ( 37 % vs 9 % ) were all significantly higher in the intervention than in the control groups , respectively ( P < .0001 for each ) , during the 12-month postintervention implementation .


Receiving any assistance was associated with a cotinine-confirmed quitting adjusted odds ratio of 1.89 ( 95 % confidence interval : 1.13-3 .19 ) .


After controlling for demographic and behavioral factors , the adjusted odds ratio for cotinine-confirmed quitting in intervention versus control practices was 1.07 ( 95 % confidence interval : 0.64-1 .78 ) .


Intervention practices had higher rates of delivering tobacco control assistance than usual care practices over the 1-year follow-up period .


Parents who received any assistance were more likely to quit smoking ; however , parents ' likelihood of quitting smoking was not statistically different between the intervention and control groups .


Maximizing parental quit rates will require more complete systems-level integration and adjunctive cessation strategies .


To examine the feasibility , acceptability , and initial efficacy of a technology-based weight loss intervention for urban , low-income mothers .


Eighteen obese , ethnic minority , socioeconomically disadvantaged mothers in the first year after childbirth were randomly assigned to either : 1 ) technology-based intervention , which included empirically supported behavior-change strategies , daily skills , and self-monitoring text messages with personalized feedback , biweekly counseling calls from a health coach , and access to a Facebook support group , or 2 ) usual-care control .


After 14 weeks of treatment , the technology-based intervention participants had significantly greater weight loss ( -2.9 3.6 kg ) than usual care ( 0.5 2.3 kg ; adjusted mean difference : -3.2 kg , 95 % confidence interval -6.2 to -0.1 kg , P = .04 ) .


One-third of intervention participants ( 3 of 9 ) and no control participants lost > 5 % of their initial body weight at follow up .


Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities .


A let-7 microRNA-complementary site ( LCS6 ) polymorphism in the 3 ' untranslated region of the KRAS gene has been shown to disrupt let-7 binding and upregulate KRAS expression .


We evaluated the LCS6 genotype and its association with KRAS mutation status , clinicopathologic features , and disease-free survival ( DFS ) in patients with stage III colon cancer who enrolled in a phase III clinical trial ( NCCTG N0147 ) .


The LCS6 genotype was assayed by real-time PCR in DNA extracted from whole blood ( n = 2,834 ) and compared with paired tumor tissue ( n = 977 ) .


( 2 ) and two-sample t tests were used to compare baseline factors and KRAS mutation status between patients defined by LCS6 variant status .


Log-rank tests and multivariate Cox models assessed associations between LCS6 status and DFS , respectively .


We identified 432 ( 15.2 % ) blood samples and 143 ( 14.6 % ) tumor samples heterozygous or homozygous for the LCS6 G-allele , and 2,402 of 2,834 ( 84.8 % ) blood samples and 834 of 977 ( 85.4 % ) tumor samples homozygous for the LCS6 T-allele .


Genotype results were highly concordant ( 99.8 % ) in cases with paired blood and tumor tissue ( n = 977 ) .


G-allele carriers were significantly more frequent in Caucasians versus other races ( ( 2 ) test , P < 0.0001 ) .


The LCS6 genotype was not associated with KRAS mutation status , clinicopathologic features ( all P > 0.2 ) , or DFS ( log-rank P = 0.49 ; HR , 0.929 ; 95 % confidence interval , 0.76-1 .14 ) , even after combining LCS6 genotype with KRAS mutation status .


In the largest association study investigating the LCS6 polymorphism in colon cancers , the germline LCS6 genotype was not associated with KRAS mutation status or with clinical outcome in patients with stage III tumors .


To assess whether an interdisciplinary intervention is more effective than usual care for improving the health-related quality of life ( HRQoL ) among patients with fibromyalgia ( FM ) , and to identify variables that were predictors of improvement in HRQoL .


In a randomized controlled clinical trial carried out on an outpatient basis in a hospital pain management unit , 153 patients with FM were randomly allocated to an experimental group ( EG ) or a control group ( CG ) .


Participants completed the Fibromyalgia Impact Questionnaire ( FIQ ) at baseline and 6months after the intervention .


The EG received an interdisciplinary treatment ( 12 sessions for 6weeks ) which consisted of coordinated psychological , medical , educational , and physiotherapeutic interventions while the CG received standard-of-care pharmacologic treatment .


Descriptive statistics , ANOVA , Chi square and Fisher tests and generalized linear models were used for data analysis .


Six months after the intervention , statistically significant improvements in HRQoL were observed in physical functioning ( P = 0.01 ) , pain ( P = 0.03 ) and total FIQ score ( P = 0.04 ) in the EG compared to the CG .


The number of physical illnesses was identified as a predictor for improvement .


This interdisciplinary intervention has shown effectiveness in improving the HRQoL of this sample of patients with FM .


The number of physical illnesses was identified as a predictor of that improvement .


To determine the short-term efficacy of oral glucosamine supplementation by evaluating structural lesions in the knee joints , as assessed using 3T magnetic resonance imaging ( MRI ) .


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


Recruitment was performed via mass mailings and an arthritis registry in southwestern Pennsylvania .


In total , 201 participants with mild-to-moderate pain in one or both knees , as defined by a Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain score 25 and 100 , were enrolled .


Of these subjects , 69.2 % had a Kellgren/Lawrence grade 2 in at least 1 knee .


Participants received 24 weeks of treatment with 1,500 mg glucosamine hydrochloride in beverage form or a placebo beverage .


The primary outcome was decreased worsening of cartilage damage on 3T MRI of both knees , assessed according to a validated scoring system , the Whole-Organ MRI Score ( WORMS ) .


Secondary outcomes included change in bone marrow lesion ( BML ) scores in all knees and change in excretion of urinary C-terminal crosslinking telopeptide of type II collagen ( CTX-II ) .


The adjusted odds ratio ( OR ) for the likelihood of decreased cartilage damage over 24 weeks in any WORMS-scored subregion of the knee in the glucosamine treatment group compared to the control group was 0.938 ( 95 % confidence interval [ 95 % CI ] 0.528 , 1.666 ) .


Compared to subjects treated with glucosamine , control subjects showed more improvement in BMLs ( adjusted OR 0.537 , 95 % CI 0.291 , 0.990 ) but no difference in worsening BMLs ( adjusted OR 0.691 , 95 % CI 0.410 , 1.166 ) over 24 weeks .


There was no indication that treatment with glucosamine decreased the excretion of urinary CTX-II ( = -0.10 , 95 % CI -0.21 , 0.002 ) .


The results of this short-term study provide no evidence of structural benefits ( i.e. , improvements in MRI morphologic features or urinary CTX-II excretion ) from glucosamine supplementation in individuals with chronic knee pain .


Polymorphisms of genes encoding the Fcy receptors ( Fc fragment of IgG receptor 2A ( FCGR2A ) and 3A ( FCGR3A ) ) , which influence their affinity for the Fc fragment , have been linked to the pharmacodynamics of monoclonal antibodies .


Most studies have been limited by small samples sizes and have reported inconsistent associations between the FCGR2A and the FCGR3A polymorphisms and clinical outcome in metastatic colorectal cancer ( mCRC ) patients treated with cetuximab .


We investigated the association of these polymorphisms and clinical outcome in a large cohort of mCRC patients treated with first-line 5-fluorouracil/folinic acid and oxaliplatin ( Nordic FLOX ) + / - cetuximab in the NORDIC-VII study ( NCT00145314 ) .


504 and 497 mCRC patients were evaluable for the FCGR2A and FCGR3A genotyping , respectively .


Genotyping was performed on TaqMan ABI HT 7900 ( Applied Biosystems , Foster City , CA , USA ) with pre-designed SNP genotyping assays for FCGR2A ( rs1801274 ) and FCGR3A ( rs396991 ) .


The response rate for patients with the FCGR2A R/R genotype was significantly increased when cetuximab was added to Nordic FLOX ( 31 % versus 53 % , interaction P = 0.03 ) , but was not significantly different compared to the response rate of patients with the FCGR2A H/H or H/R genotypes given the same treatment .


A larger increase in response rate with the addition of cetuximab to Nordic FLOX in patients with KRAS mutated tumors and the FCGR2A R/R genotype was observed ( 19 % versus 50 % , interaction P = 0.04 ) .


None of the FCGR3A polymorphisms were associated with altered response when cetuximab was added to Nordic FLOX ( interaction P = 0.63 ) .


Neither of the FCGR polymorphisms showed any significant associations with progression-free survival or overall survival .


Patients with KRAS mutated tumors and the FCGR2A R/R polymorphism responded poorly when treated with chemotherapy only , and experienced the most benefit of the addition of cetuximab in terms of response rate .