The primary end point was the proportion of recurrence-free patients at week 104 .


Diverticulitis recurrence was defined as surgical intervention at any time for diverticular disease or presence of computed tomography scan results demonstrating bowel wall thickening ( > 5 mm ) and/or fat stranding consistent with diverticulitis .


For a portion of the study , recurrence also required the presence of abdominal pain and an increase in white blood cells .


Mesalamine did not reduce the rate of diverticulitis recurrence at week 104 .


Among patients in PREVENT1 , 53 % -63 % did not have disease recurrence , compared with 65 % of those given placebo .


Among patients in PREVENT2 , 59 % -69 % of patients did not have disease recurrence , compared with 68 % of those given placebo .


Mesalamine did not reduce time to recurrence , and the proportions of patients requiring surgery were comparable among treatment groups .


No new adverse events were identified with mesalamine administration .


Mesalamine was not superior to placebo in preventing recurrent diverticulitis .


Mesalamine is not recommended for this indication .


ClinicalTrials.gov ID : NCT00545740 and NCT00545103 .


Prior work aimed at improving our understanding of human cerebral autoregulation has explored individual physiological mechanisms of autoregulation in isolation , but none has attempted to consolidate the individual roles of these mechanisms into a comprehensive model of the overall cerebral pressure-flow relationship .


We retrospectively analyzed this relationship before and after pharmacological blockade of - adrenergic - , muscarinic - , and calcium channel-mediated mechanisms in 43 healthy volunteers to determine the relative contributions of the sympathetic , cholinergic , and myogenic controllers to cerebral autoregulation .


Projection pursuit regression was used to assess the effect of pharmacological blockade on the cerebral pressure-flow relationship .


Subsequently , ANCOVA decomposition was used to determine the cumulative effect of these 3 mechanisms on cerebral autoregulation and whether they can fully explain it .


Sympathetic , cholinergic , and myogenic mechanisms together accounted for 62 % of the cerebral pressure-flow relationship ( P < 0.05 ) , with significant and distinct contributions from each of the 3 effectors .


ANCOVA decomposition demonstrated that myogenic effectors were the largest determinant of the cerebral pressure-flow relationship , but their effect was outside of the autoregulatory region where neurogenic control appeared prepotent .


Our results suggest that myogenic effects occur outside the active region of autoregulation , whereas neurogenic influences are largely responsible for cerebral blood flow control within it .


However , our model of cerebral autoregulation left 38 % of the cerebral pressure-flow relationship unexplained , suggesting that there are other physiological mechanisms that contribute to cerebral autoregulation .


This study examined relationships between activities of daily living ( ADL ) motor and process skills , unimanual capacity , bimanual performance , and visual perception in children with unilateral cerebral palsy ( CP ) .


Participants were 101 children with unilateral CP ( 51 males , 50 females ; mean age 11y 9mo [ SD 2y 5mo ; range 8-17y ] ; Manual Ability Classification System [ MACS ] level I = 24 ; level II = 76 ; level III = 1 ) .


Measures were ( 1 ) Assessment of Motor and Process Skills ( AMPS ) , ( 2 ) Jebsen-Taylor Test of Hand Function ( JTTHF ) , ( 3 ) Assisting Hand Assessment ( AHA ) , and ( 4 ) Test of Visual Perceptual Skills , 3rd edition ( TVPS-3 ) .


Regression models were constructed with the AMPS motor scale and AMPS process as the dependent variables .


The AHA and JTTHF dominant upper limb score together explained 57 % of the variance in AMPS motor scale scores .


TVPS-3 Visual Sequential Memory , TVPS-3 Visual Closure , and JTTHF dominant upper limb score together explained 35 % of the variance in AMPS process scale scores .


Bimanual performance and unimanual capacity of the dominant upper limb are significantly associated with ADL motor skills in children with unilateral CP .


Process skills of ADL are related to visual perceptual ability and dominant upper limb unimanual capacity , which may reflect motor planning required to perform daily tasks .


Before this study started , the standard postoperative chemotherapy regimen for stage II-III Wilms ' tumour pretreated with chemotherapy was to include doxorubicin .


However , avoidance of doxorubicin-related cardiotoxicity effects is important to improve long-term outcomes for childhood cancers that have excellent prognosis .


We aimed to assess whether doxorubicin can be omitted safely from chemotherapy for stage II-III , histological intermediate-risk Wilms ' tumour when a newly defined high-risk blastemal subtype was excluded from randomisation .


For this international , multicentre , open-label , non-inferiority , phase 3 , randomised SIOP WT 2001 trial , we recruited children aged 6 months to 18 years at the time of diagnosis of a primary renal tumour from 251 hospitals in 26 countries who had received 4 weeks of preoperative chemotherapy with vincristine and actinomycin D. Children with stage II-III intermediate-risk Wilms ' tumours assessed after delayed nephrectomy were randomly assigned ( 1:1 ) by a minimisation technique to receive vincristine 15 mg/m ( 2 ) at weeks 1-8 , 11 , 12 , 14 , 15 , 17 , 18 , 20 , 21 , 23 , 24 , 26 , and 27 , plus actinomycin D 45 g/kg every 3 weeks from week 2 , either with five doses of doxorubicin 50 mg/m ( 2 ) given every 6 weeks from week 2 ( standard treatment ) or without doxorubicin ( experimental treatment ) .


The primary endpoint was non-inferiority of event-free survival at 2 years , analysed by intention to treat and a margin of 10 % .


Assessment of safety and adverse events included systematic monitoring of hepatic toxicity and cardiotoxicity .


This trial is registered with EudraCT , number 2007-004591-39 , and is closed to new participants .


Between Nov 1 , 2001 , and Dec 16 , 2009 , we recruited 583 patients , 341 with stage II and 242 with stage III tumours , and randomly assigned 291 children to treatment including doxorubicin , and 292 children to treatment excluding doxorubicin .


Median follow-up was 608 months ( IQR 408-798 ) .


2 year event-free survival was 926 % ( 95 % CI 896-957 ) for treatment including doxorubicin and 882 % ( 845-921 ) for treatment excluding doxorubicin , a difference of 44 % ( 95 % CI 04-93 ) that did not exceed the predefined 10 % margin .


5 year overall survival was 965 % ( 943-988 ) for treatment including doxorubicin and 958 % ( 933-984 ) for treatment excluding doxorubicin .


Four children died from a treatment-related toxic effect ; one ( < 1 % ) of 291 receiving treatment including doxorubicin died of sepsis , three ( 1 % ) of 292 receiving treatment excluding doxorubicin died of varicella , metabolic seizure , and sepsis during treatment for relapse .


17 patients ( 3 % ) had hepatic veno-occlusive disease .


Cardiotoxic effects were reported in 15 ( 5 % ) of 291 children receiving treatment including doxorubicin .


12 children receiving treatment including doxorubicin , and ten children receiving treatment excluding doxorubicin , died , with the remaining deaths from tumour recurrence .


Doxorubicin does not need to be included in treatment of stage II-III intermediate risk Wilms ' tumour when the histological response to preoperative chemotherapy is incorporated into the risk stratification .


See Acknowledgments for funders .


The aim of this study was to compare the effect of pioglitazone with glimepiride on coronary arterial inflammation with serial ( 18 ) F-fluorodeoxyglucose ( FDG ) - positron emission tomography ( PET ) combined with computed tomography ( CT ) angiography .


Recent studies have shown that FDG-PET combined with CT is a reliable tool to visualize and quantify vascular inflammation .


Although pioglitazone significantly prevented the progression of coronary atherosclerosis and reduced the recurrence of myocardial infarction in patients with type 2 diabetes mellitus ( DM ) , it remains unclear whether pioglitazone could attenuate coronary artery inflammation .


Fifty atherosclerotic patients with impaired glucose tolerance or type 2 DM underwent determination of blood chemistries , anthropometric and inflammatory variables , and FDG-PET/CT angiography , and then were randomized to receive either pioglitazone or glimepiride for 16 weeks .


Effects of the treatments on vascular inflammation of the left main trunk were evaluated by FDG-PET/CT angiography at baseline and end of the study .


Vascular inflammation of the left main trunk was measured by blood-normalized standardized uptake value , known as a target-to-background ratio .


Three patients dropped out of the study during the assessment or treatment .


Finally , 25 pioglitazone-treated patients and 22 glimepiride-treated patients ( 37 men ; mean age : 68.1 8.3 years ; glycosylated hemoglobin : 6.72 0.70 % ) completed the study .


After 16-week treatments , fasting plasma glucose and glycosylated hemoglobin values were comparably reduced in both groups .


Changes in target-to-background ratio values from baseline were significantly greater in the pioglitazone group than in the glimepiride group ( -0.12 0.06 vs. 0.09 0.07 , p = 0.032 ) , as well as changes in high-sensitivity C-reactive protein ( pioglitazone vs. glimepiride group : median : -0.24 [ interquartile range ( IQR ) : -1.58 to -0.04 ] mg/l vs. 0.08 [ IQR : -0.07 to 0.79 ] mg/l , p = 0.031 ) .


Our study indicated that pioglitazone attenuated left main trunk inflammation in patients with impaired glucose tolerance or DM in a glucose-lowering independent manner , suggesting that pioglitazone may protect against cardiac events in patients with impaired glucose tolerance or DM by suppressing coronary inflammation .


( Anti-Inflammatory Effects of Pioglitazone ; NCT00722631 ) .


Postoperative nausea and vomiting ( PONV ) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital .


Aromatherapy represents a complementary and alternative therapy for the management of PONV .


The objective of this study was to compare the effectiveness of aromatherapy ( QueaseEase , Soothing Scents , Inc , Enterprise , AL ) versus an unscented inhalant in relieving PONV .


One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy .


Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly ( P < .01 ) , and there was a significant difference between the two groups ( P = .03 ) .


Perceived effectiveness of aromatherapy was significantly higher in the treatment group ( P < .001 ) .


Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea .


To investigate the effects of sertraline on semen parameters and comparison of its effect with behavioral therapy ( BT ) in men with primary premature ejaculation .


In this single-blinded clinical trial , a total of 60 married men with primary premature ejaculation were randomly divided into 2 groups : the sertraline group ( n = 30 , sertraline 25 mg/day for 1 week followed by 50 mg/day for 3 months ) and the BT group ( n = 30 , using BT technique for 3 months ) .


Semen analysis was applied , and the results were compared between groups before and 3 months after intervention .


The significant reduction in sperm concentration ( 10 ( 5 ) / mL ) and percentage of normal morphology was reported in sertraline group ( P < .05 ) .


The percentage of sperm deoxyribonucleic acid fragmentation after intervention in sertraline group was significantly higher than BT group ( P = .004 ) .


There was no significant change in semen parameters in patients treated using BT .


Our study revealed detrimental effects of sertraline on some semen parameters .


It should particularly be considered in patients who are trying to conceive .


It seems BT is a safe method without any side effect on semen analysis parameters .


This study was performed to evaluate the effectiveness of Benson 's relaxation technique in the quality of sleep of hemodialysis patients .


It was a randomized controlled trial with a pre-post-test design .


A total of 86 hemodialysis patients referring to hemodialysis units were assigned to either the intervention ( receiving Benson 's relaxation technique ) or the control group ( routine care ) through block randomization .


The study was performed in two hemodialysis units affiliated to Shiraz University of Medical Sciences , Shiraz , Iran .


The patients in the intervention group listened to the audiotape of Benson 's relaxation technique twice a day each time for twenty minutes for eight weeks .


The global score of Pittsburgh Sleep Quality Index ( PSQI ) as well as its components was computed in both the intervention and the control group before and at the 8th week of the intervention .


The results of ANCOVA indicated significant differences between the two groups regarding the scores of Pittsburgh Sleep Quality Index subscales , such as sleep disturbance , daytime dysfunction , the use of sleep medication , and subjective sleep quality and as well as its global scores at the 8th week of the intervention ( p < 0.05 ) .


This study highlighted the importance of Benson 's relaxation technique in improvement of the sleep quality of the patients on hemodialysis .


Thus , educational sessions are recommended to be planned on this cost effective and easy to use relaxation technique in order to improve hemodialysis patients ' sleep quality .


Further studies are needed to assess the effectiveness of this technique in other groups of patients .


The objective of the present study was to evaluate the long-term effectiveness of an exercise program in modifying the exercise behavior of the community-dwelling elderly subjects .


This study was a single-blinded randomized controlled trial .


The subjects included 52 males and 65 females 65 years of age or over who were randomly assigned to an exercise-intervention group or a health-education group .


The stages of change in exercise behavior were evaluated before and one-year after the intervention period .


The subjects ' physical function ( muscle strength , balance , walking speed ) and self-efficacy in each domain of the physical function were measured during the intervention period .


There were no significant differences in the stages of change before the intervention between the two groups .


Significant differences in the stages of change were observed in `` relapse '' of stages at two points in time between the two groups ( p < .01 ) .


A logistic regression analysis showed that `` progression '' of stages was associated with improvements in the timed up and go test ( AOR 2.7 ; 95 % CI 1.3-5 .8 ) and sit and reach ( AOR 1.14 ; 95 % CI 1.0-1 .3 ) , while `` relapse '' of stages was associated with the group allocation ( AOR 4.6 ; 95 % CI 1.1-18 .8 ) , self-efficacy in `` Walking '' ( AOR 1.54 ; 95 % CI 1.0-2 .3 ) and `` Stair climbing '' ( AOR 0.68 ; 95 % CI 0.5-0 .9 ) with respect to physical activity during the intervention period .


The results suggest that exercise intervention in community-dwelling elderly subjects is effective in preventing `` relapse '' of exercise behavior over long periods .


Freeze-dried powdered yacon ( FDY ) can be considered a prebiotic product due to its fructooligosaccharides ( FOS ) content .


The effect of 9weeks of daily intake of FDY containing 7.4 g of FOS on glucose , lipid metabolism and intestinal transit in a group of elderly people was investigated .


Seventy-two elderly ( mean age 67.116.11 ) men and women were studied for 9weeks in a double-blind , placebo-controlled experiment .


They were randomly assigned to the supplement group ( which received 7.4 g of FOS as FDY ) or the control group .


At the beginning and end of the study , anthropometric measurements , blood sampling , clinical analyses and dietary intake were assessed .


A daily intake of FDY containing 7.4 g of FOS for 9weeks was associated with a mean decrease in serum glucose ( p = 0.013 ) , but supplementation did not reduce serum lipids in the study group .


The administered dose did not adversely affect intestinal transit .


It did not cause bloating , flatulence or intestinal discomfort .


Freeze-dried powdered yacon is a good source of FOS , and daily consumption can have a favourable effect on serum glucose in the elderly .


It is also practical , easy and safe to use and store .


UK guidelines recommend that all early active rheumatoid arthritis ( RA ) patients are offered combination disease-modifying antirheumatic drugs ( DMARDs ) and short-term corticosteroids .


Anti-citrullinated protein antibody ( ACPA ) - positive and ACPA-negative RA may differ in their treatment responses .


We used data from a randomized controlled trial - the Combination Anti-Rheumatic Drugs in Early RA ( CARDERA ) trial - to examine whether responses to intensive combination treatments in early RA differ by ACPA status .


The CARDERA trial randomized 467 early active RA patients to receive : ( 1 ) methotrexate , ( 2 ) methotrexate/ciclosporin , ( 3 ) methotrexate/prednisolone or ( 4 ) methotrexate/ciclosporin/prednisolone in a factorial-design .


Patients were assessed every six months for two years .


In this analysis we evaluated 431 patients with available ACPA status .


To minimize multiple testing we used a mixed-effects repeated measures ANOVA model to test for an interaction between ACPA and treatment on mean changes from baseline for each outcome ( Larsen , disease activity scores on a 28-joint count ( DAS28 ) , Health Assessment Questionnaire ( HAQ ) , EuroQol , SF-36 physical component summary ( PCS ) and mental component summary ( MCS ) scores ) .


When a significant interaction was present , mean changes in outcomes were compared by treatment group at each time point using t-tests stratified by ACPA status .


Odds ratios ( ORs ) for the onset of new erosions with treatment were calculated stratified by ACPA .


ACPA status influenced the need for combination treatments to reduce radiological progression .


ACPA-positive patients had significant reductions in Larsen score progression with all treatments .


ACPA-positive patients receiving triple therapy had the greatest benefits : two-year mean Larsen score increases comprised 3.66 ( 95 % confidence interval ( CI ) 2.27 to 5.05 ) with triple therapy and 9.58 ( 95 % CI 6.76 to 12.39 ) with monotherapy ; OR for new erosions with triple therapy versus monotherapy was 0.32 ( 95 % CI 0.14 to 0.72 ; P = 0.003 ) .


ACPA-negative patients had minimal radiological progression irrespective of treatment .


Corticosteroid 's impact on improving DAS28/PCS scores was confined to ACPA-positive RA .


ACPA status influences the need for combination DMARDs and high-dose tapering corticosteroids in early RA .


In CARDERA , combination therapy was only required to prevent radiological progression in ACPA-positive patients ; corticosteroids only provided significant disease activity and physical health improvements in ACPA-positive disease .


This suggests ACPA is an important biomarker for guiding treatment decisions in early RA .


Current Controlled Trials ISRCTN32484878 .


To assess change in intraocular pressure ( IOP ) in patients with neovascular age-related macular degeneration ( NVAMD ) receiving intravitreal aflibercept injection ( IAI ) or ranibizumab in VEGF Trap-Eye : Investigation of Efficacy and Safety in Wet AMD ( VIEW ) 1 and 2 studies .


Analyses from 2 randomized , active-controlled , phase III trials .


A total of 2457 patients with NVAMD .


Patients received IAI 2 mg every ( q ) 4 weeks ( 2q4 ) , 0.5 mg q4 weeks ( 0.5 q4 ) , 2 mg q8 weeks ( after 3 monthly doses ; 2q8 ) , or ranibizumab 0.5 mg q4 weeks ( Rq4 ) for 52 weeks .


At week 52 , patients were switched to a variable regimen requiring at least quarterly dosing and allowing interim injections based on anatomic and visual assessment .


Pre-injection IOP was analyzed in study and uninjected fellow eyes from baseline to week 96 .


Prespecified end points included mean change in IOP from baseline and prevalence of a > 21 mmHg and > 10 mmHg increase in IOP from baseline .


Cumulative incidence of sustained ( at 2 consecutive visits ) IOP > 21 mmHg , a single event of IOP > 25 mmHg , and sustained IOP increase from baseline ( 5 mmHg ) was also evaluated .


Mean IOP change from baseline over 96 weeks in all IAI groups was consistently lower than in the Rq4 group , and this finding was replicated in both trials .


In an analysis integrating both studies , the proportion of study eyes with IOP > 21 mmHg at week 96 was 20.2 % , 14.2 % , 12.1 % , and 12.5 % in Rq4 , 2q4 , 2q8 , and 0.5 q4 , respectively .


Reduction in risk , relative to Rq4 , of having sustained IOP > 21 mmHg over 96 weeks was 62 % ( 95 % confidence interval [ CI ] , 36 % -78 % ) , 50 % ( 95 % CI , 19 % -70 % ) , and 69 % ( 95 % CI , 45 % -84 % ) for 2q4 , 2q8 , and 0.5 q4 , respectively .


Risk reduction in the IAI groups for a sustained IOP increase 5 mmHg was 31 % ( 95 % CI , 8 % -48 % ) , 38 % ( 95 % CI , 17 % -54 % ) , and 47 % ( 95 % CI , 27 % -61 % ) , respectively .


In uninjected fellow eyes , only sustained IOP > 21 mmHg events were higher in the Rq4 group compared with all IAI groups .


Incidence of elevated IOP in eyes with NVAMD was lower in all IAI groups than in the ranibizumab group .


The study aimed to investigate the analgesic effect of a combination of intravenous flurbiprofen axetil and opioids , and evaluate the relationship between refractory pain relief and plasma - endorphin levels in cancer patients .


A total of 120 cancer patients was randomly divided into two groups , 60 patients took orally morphine sulfate sustained-release tablets in group A , and another 60 patients receiving the combination treatment of intravenous flurbiprofen axetil and opioid drugs in group B.


After 7 days , pain relief , quality of life improvement and side effects were evaluated .


Furthermore , plasma - endorphin levels were measured by radioimmunoassay .


With the combination treatment of intravenous intravenous flurbiprofen axetil and opioids , the total effective rate of pain relief rose to 91.4 % , as compared to 82.1 % when morphine sulfate sustained-release tablet was used alone .


Compared with that of group A , the analgesic effect increased in group B ( p = 0.031 ) .


Moreover , satisfactory pain relief was associated with a significant increase in plasma - endorphin levels .


After the treatment , plasma - endorphin level in group B was 62.413.5 pg/ml , which was higher than that in group A ( 45.811.2 pg/ml ) ( p < 0.05 ) .


Our results suggest the combination of intravenous flurbiprofen axetil and opioids can enhance the analgesic effect of opioid drugs by increasing plasma - endorphin levels , which would offer a selected and reliable strategy for refractory cancer pain treatment .


This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus .


This 6-month prospective , randomized , comparative , open , multicenter study included patients with type 1 diabetes > 18 years old treated with multiple insulin doses and with a glycated hemoglobin ( HbA1c ) level of > 8 % .


We compared an intervention group ( IG ) ( two face-to-face and five telematic appointments ) with a control group ( CG ) ( seven face-to-face appointments ) .


The variables studied were ( 1 ) patient and healthcare team costs , ( 2 ) metabolic control , ( 3 ) knowledge of diabetes , ( 4 ) quality of life , and ( 5 ) self-care treatment adherence .


Of the 154 patients included , 118 ( 76.6 % ) completed the study ( IG , 54 ; CG , 64 ) .


The time used by the CG to follow the program was 823645 min versus 353222 min in the IG ( P < 0.0001 ) .


Compared with the CG , the IG required less healthcare time from the professionals ( 288105 min vs. 23289 min ; P < 0.001 ) .


HbA1c improved in both groups ( IG , 9.21.5 % [ 77.017.0 mmol/mol ] vs. 8.71.5 % [ 71.617.0 mmol/mol ] [ P < 0.001 ] ; CG , 9.20.9 % [ 77.010.0 mmol/mol ] vs. 8.60.9 % [ 70.510.0 mmol/mol ] [ P < 0.001 ] , as did knowledge and self-care treatment adherence .


The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy , providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control , knowledge acquisition , and self-care treatment adherence , with a significant reduction in the time used , especially by patients .


The safety and tolerability of a new low-dose levonorgestrel/ethinyl estradiol ( LNG/EE ) contraceptive patch was compared with 2 combination oral contraceptives in 2 clinical studies in which approximately 30 % of enrolled participants were obese .


Two phase 3 , open-label , randomized , parallel-group , multicenter trials compared the LNG/EE contraceptive patch ( n = 1579 ) with combination oral contraceptives ( n = 581 ) in healthy women 17-40 years of age .


Combination oral contraceptives were LNG 100 g per EE 20 g ( combination oral contraceptive 20 ; n = 375 ) or LNG 150 g per EE 30 g ( combination oral contraceptive 30 ; n = 206 ) .


Safety and tolerability data from the 2 trials were evaluated in integrated safety analyses .


Treatment-emergent adverse events of 2 % or greater in the LNG/EE contraceptive patch were nasopharyngitis ( 5.2 % ) , nausea ( 4.1 % ) , upper respiratory infection ( 3.5 % ) , headache ( 3.4 % ) , sinusitis ( 2.9 % ) , cervical dysplasia ( 2.3 % ) , and urinary tract infection ( 2.1 % ) .


Including skin reaction-related treatment-emergent adverse events , the proportion of women who experienced any treatment-emergent adverse event was similar among women randomized to the contraceptive patch ( 47.5 % ) , the combination oral contraceptive 20 ( 47.4 % ) , or the combination oral contraceptive 30 ( 46.8 % ) .


The incidence of treatment-emergent adverse events was similar in obese vs nonobese participants in all groups .


Serious adverse events occurred in less than 1 % of participants in any of the treatment groups .


The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women .


Nocturia is prevalent and bothersome in men with lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) .


- Adrenoceptor antagonists without subtype selectivity have inconsistently shown significant effects on nocturia in these patients .


We explored the effects of the 1A-adrenoceptor subtype-selective antagonist silodosin on nocturia by analyzing three placebo-controlled registration studies .


Responses to question 7 of the IPSS questionnaire were analyzed for the entire study population and patients with 2 voids/night at baseline .


Improvement/worsening rates for nocturia were calculated for once-daily silodosin 8 mg and placebo .


Silodosin effects on the mean number of nocturnal voids were compared with placebo , and the number of patients in whom nocturia was reduced to < 2 times was calculated .


In total , 1,479 men were treated with silodosin or placebo ; 1,266 men ( 85 % ) had 2 voids/night at baseline .


Compared to placebo , more men treated with silodosin reported about nocturia improvement ( 53.4 vs. 42.8 % , p < 0.0001 ) and fewer patients about worsening ( 9.0 vs. 14.3 % , p < 0.0001 ) .


Silodosin significantly reduced nocturia within each study and pooled cohort compared to placebo ( p < 0.001 ) .


In men with 2 nocturnal voids at baseline , 61 and 49 % of patients with silodosin and placebo had reductions of 1 voids/night , respectively ( p = 0.0003 ) , and significantly more patients with silodosin had < 2 nocturia episodes at study end compared to placebo ( 29.3 vs. 19.0 % ; p = 0.0002 ) .


Although a weak impact on nocturia is already known from - adrenoceptor antagonists without subtype selectivity , the individual placebo-controlled studies and the pooled data analysis showed that the 1A-adrenoceptor subtype-selective antagonist silodosin consistently and significantly improves nocturia in men with LUTS/BPH .


To investigate how COPD patients respond to motivational cues that aim to improve activity behavior and how these responses are related to cue - and context characteristics .


In addition , to explore whether activity can be increased and better distributed over the day by providing such cues .


Fifteen COPD patients participated .


Patients used an activity sensor with a smartphone for four weeks , at least four days/week .


Patients received motivational cues every 2h with advice on how to improve their activity , on top of real-time visual feedback .


The response was calculated by the amount of activity 30 min before and after a cue .


In total , 1488 cues were generated .


The amount of activity significantly decreased in the 30 min after a discouraging cue ( p < 0.001 ) and significantly increased ( p < 0.05 ) in the 10 min after an encouraging cue .


The activity level increased with 13 % in the intervention period compared to corrected baseline ( p = 0.008 ) .


The activity was not more balanced over the day .


COPD patients significantly change their activity level in response to motivational cues , based on continuous ambulatory assessment of activity levels .


Motivational cues could be a valuable component of telemedicine interventions that aim to improve activity behavior .


To estimate the cost-effectiveness of a supported employment ( SE ) intervention that had been previously found effective in veterans with spinal cord injuries ( SCIs ) .


Cost-effectiveness analysis , using cost and quality-of-life data gathered in a trial of SE for veterans with SCI .


SCI centers in the Veterans Health Administration .


Subjects ( N = 157 ) who completed a study of SE in 6 SCI centers .


Subjects were randomly assigned to the intervention of SE ( n = 81 ) or treatment as usual ( n = 76 ) .


A vocational rehabilitation program of SE for veterans with SCI .


Costs and quality-adjusted life years , which were estimated from the Veterans Rand 36-Item Health Survey , extrapolated to Veterans Rand 6 Dimension utilities .


Average cost for the SE intervention was $ 1821 .


In 1 year of follow-up , estimated total costs , including health care utilization and travel expenses , and average quality-adjusted life years were not significantly different between groups , suggesting the Spinal Cord Injury Vocational Integration Program intervention was not cost-effective compared with usual care .


An intensive program of SE for veterans with SCI , which is more effective in achieving competitive employment , is not cost-effective after 1 year of follow-up .


Longer follow-up and a larger study sample will be necessary to determine whether SE yields benefits and is cost-effective in the long run for a population with SCI .


To study an effect of immunomodulatory therapy with cycloferon on some immunological parameters in patients with depression .


It was examined 192 patients with recurrent depressive disorders .


All patients were randomized into two groups -- main group ( 98 patients ) and comparison group ( 94 patients ) .


Both groups received standard treatment with antidepressants and antipsychotics in ambulatory conditions .


Patients of the main group additionally received cycloferon .


Before treatment , there was an increase in concentrations of circulatory immune complexes ( CIC ) , mainly due to most pathogenic average molecular ( 11S-19S ) and small molecular ( < 11S ) fractions , in both groups of the patients .


A direct correlation between the degree of the severity of the disease and the degree of changes in immunological parameters was noted .


Inclusion of cycloferon in the complex treatment had a positive effect on immunological parameters and led to the normalization of CIC levels and their fraction content .


To evaluate the effectiveness of the Bathing Without a Battle intervention in reducing physical and verbal aggressive behaviors for nursing home residents with dementia .


A randomized crossover diffusion study , with one group receiving the intervention after one round of baseline observations and a delayed intervention group receiving the intervention after two rounds of baseline observations .


Six nursing home facilities in the state of New York .


Nursing home residents with dementia ( N = 240 ) .


The Bathing Without a Battle educational program , designed for direct-care staff members responsible for bathing residents diagnosed with dementia and implemented through a train-the-trainer model .


Rates of verbal and physical aggressive and agitated behaviors were measured using the Care Recipient Behavior Assessment ; secondary measures of effect included bath duration , bath modality , and antipsychotic medication use .


In spite of implementation obstacles ( consent delays and change in leadership at one facility ) , a significant change was observed in how residents were bathed that translated into a significant reduction in the rate of aggressive and agitated behaviors , particularly verbal , during residents ' baths .


The use of in-bed baths increased 17 % , and average bath duration decreased significantly ( average 1.5 minutes less ) in the postintervention period , particularly for in-bed baths .


Verbal behaviors declined 17.8 % ( P = .008 ) , combined verbal and physical behaviors declined 18.6 % ( P = .004 ) , and antipsychotic use declined 30 % ( P = .002 ) after the intervention .


The Bathing Without a Battle educational program , delivered through a train-the-trainer format , is an effective means of improving the bathing experience of residents with dementia in nursing homes .


This research supports broadly adopting this intervention , especially for nursing homes serving many residents with dementia .


Human papillomavirus ( HPV ) is one of the most common sexually transmitted infections and is the cause of several different diseases in men and women .


Although little is known about HPV infection in men , they are also in the risk group of HPV infection and play an important role in transmitting the virus to women .


To define the efficacy of the HPV vaccine through cross-immunization and its role in clearance of HPV infection , and to assess infection-associated factors in men .


This prospective randomized clinical study enrolled 171 evaluable men with genital warts between June 2009 and October 2013 .


After the initial treatment intervention , 91 patients were randomly assigned to receive HPV vaccine in three doses .


Eighty patients were in the control ( unvaccinated ) group .


One hundred-eleven men were single and 60 men were married .


Patients who had previous treatment for pre-existing warts and medical disorders that needed chronic treatment or immunosuppression were not included in the randomization .


Also 29 men with follow-up less than 12 months and incomplete vaccination were not included .


The patients were assessed regarding age , condom use , marital status , number of visible genital warts , and smoking status .


Post-treatment follow-up was monthly up to 12th month .


Mean age was 347.6 .


One hundred fifteen patients were smokers .


For the recurrence of warts , age , smoking , vaccination status were insignificant and marital status was significant in the univariable analysis ; only marital status preserved significance ( HR : 2.0 CI :1.29 -3.12 P = 0.002 ) in the multivariable analysis including vaccination status , marital status , and smoking .


Among the investigated factors vaccination status was not but marital status significantly influenced wart recurrence .


Married men had more recurrences in our population .


Larger multicenter randomized clinical trials are lacking and seriously required to investigate the therapeutic effect of current quadrivalent HPV vaccine in genital warts .


Fatigue is a core symptom in fibromyalgia that can negatively affect a patient 's quality of life .


The objective of this study was to analyze fatigue-related data from 3 randomized , placebo-controlled trials of milnacipran ( n = 3109 ) in fibromyalgia patients .


Fatigue was assessed with the Multidimensional Fatigue Inventory ( MFI ) .


Treatment effects were evaluated by changes in MFI total scores and identifying patients with improvement of 30 % or greater from baseline .


Path analyses were conducted to evaluate direct and indirect effects of treatment on fatigue .


Patients had high levels of baseline fatigue ; mean MFI total score was 68.1 ( of 100 ) .


After 3 months of stable-dose treatment , patients receiving milnacipran 100 and/or 200 mg/d had significant improvement in MFI total and subscale scores ( P < 0.05 vs placebo ) .


The largest treatment effect was found in patients with equal to or greater than 20 % to 40 % fatigue improvement .


Significantly more patients met the threshold of 30 % or greater with milnacipran ( 100 mg/d , 17.6 % ; 200 mg/d , 15.2 % ) than with placebo ( 9.9 % ) ; odds ratios for this responder status were 1.93 and 1.63 , respectively ( P < 0.05 for both doses ) .


Path analyses indicated that up to 28 % of fatigue improvement may be attributed to direct milnacipran effects ( ie , not indirectly through effects on pain or other symptoms ) .


Fibromyalgia patients in the milnacipran studies had high levels of baseline fatigue .


Patients receiving milnacipran had statistically significant and clinically meaningful reductions in fatigue that were not completely attributable to indirect treatment effects through pain reduction .


Evaluating and managing fatigue are an important clinical concern when treating patients with fibromyalgia .


To evaluate women 's preferences for timing of elective cesarean section ( ECS ) scheduled prior to versus after 39 completed weeks .


Secondary analyses from a randomized controlled open-label trial were conducted at seven Danish tertiary hospitals from March 2009 to June 2011 with inclusion of singleton pregnant women with a healthy fetus .


The women were allocated by a computerized telephone system to ECS scheduled at 38 ( +3 ) weeks or 39 ( +3 ) weeks of gestation .


Dissatisfaction with timing of ECS and preferred timing of the procedure in a proposed future ECS delivery were evaluated .


Data analyses were done by intention-to-treat , using logistic regression .


A total of 1196 women ( 94 % ) completed an online questionnaire at follow-up eight weeks postpartum .


In the 38 weeks group , 61 ( 10 % ) women 601 were dissatisfied with the timing of their ECS , whereas in the 39 weeks group 157 ( 26 % ) of 595 were dissatisfied ( adjOR 3.18 , 95 % CI 2.30 ; 4.40 ) .


The proportion of women who preferred the same timing in a future ECS were 272 ( 45 % ) in the 38 weeks group compared to 232 ( 39 % ) in the 39 ( +3 ) weeks group ( adjOR 0.75 , 95 % CI 0.60 ; 0.95 ) .


The women in this trial preferred ECS scheduled prior to 39 weeks of gestation .


The pharmacokinetics of raltegravir ( RAL ) in HIV patients is characterized by high interindividual and intraindividual variability .


We documented previously that HIV patients taking RAL at 400 mg bid by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability than patients taking the drug by swallowing the tablets .


This study extends our previous findings .


An open-label , 2-period crossover study compared the pharmacokinetics of 2 doses of RAL given at 400 mg every 12 hours ( that mimics a bid administration ) by swallowing with 1 dose of 800 mg ( that mimics a qd administration ) by chewing the tablets in 12 healthy volunteers .


RAL plasma concentrations were measured by a chromatographic method coupled with mass spectrometry .


Subjects taking RAL by chewing had significantly higher drug exposure ( RAL area under the curve [ AUC ] ( 0-24 ) : 40722 14843 versus 21753 12229 ng h/mL , P < 0.0001 ) and reduced pharmacokinetic variability compared with those taking the drug by swallowing the whole tablet , with no difference in the minimum RAL concentrations ( RAL C ( min ) : 36 23 versus 43 23 ng/mL , P = 0.298 ) .


Subjects taking RAL by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability compared with those taking the drug by swallowing .


No differences were observed in the minimum RAL concentrations .


RAL at 800 mg once daily by chewing the tablets may represent a novel therapeutic option for the treatment of HIV being associated with higher drug absorption , reduced pharmacokinetic variability , and potentially better compliance compared with patients swallowing the 400-mg bid intact tablets .


Piriformis fossa entry antegrade femoral nailing is a common method for stabilizing diaphyseal femur fractures .


However , clinically significant complications such as chronic hip pain , hip abductor weakness , heterotopic ossification and femoral head osteonecrosis have been reported .


A recent cadaveric study found that piriformis entry nailing damaged either the deep branch of the medial femoral circumflex artery ( MFCA ) or its distal superior retinacular artery branches in 100 % of specimens and therefore recommended against its use .


However , no study has quantitatively assessed the effect of different femoral entry points on femoral head perfusion .


Twelve fresh-frozen cadaveric lower extremity specimens were randomly allocated to either piriformis fossa or trochanteric entry nailing using a 13-mm reamer .


The contralateral hip served as an internal matched control .


All specimens subsequently underwent gadolinium-enhanced fat-suppressed gradient-echo sequence MRI to assess femoral head perfusion .


Gross dissection was also performed to assess MFCA integrity and distance to the opening reamer path .


MRI quantification analysis revealed near full femoral head perfusion with no significant difference between the piriformis and trochanteric starting points ( 95 vs. 97 % , p = 0.94 ) .


There was no observed damage to the deep MFCA in either group .


The mean distance from the reamer path to the deep MFCA was 3.2 mm in the piriformis group compared to 18.5 mm in the trochanteric group ( p = 0.001 ) .


Additionally , there was a significantly greater number of mean terminal superior retinacular vessels damaged by the opening reamer in the piriformis cohort ( 1 vs. 0 ; p = 0.007 ) .


No statistically significant difference in femoral head perfusion was found between the two groups .


Therefore , we can not recommend against the use of piriformis entry femoral nails .


However , we caution against multiple errant starting point attempts and recommend meticulous soft tissue protection during the procedure .


Few clinical trials have evaluated the efficacy and safety of Tripterygium wilfordii Hook F ( TwHF ) compared with acitretin in psoriasis .


We aimed to compare the efficacy and safety of TwHF compared with acitretin in the treatment of moderate to severe psoriasis vulgaris .


Adults with Psoriasis Area Severity Index ( PASI ) score 10 and psoriasis-affected body surface area 10 % were randomized into a TwHF ( 20 mg , 3 times a day ) or acitretin group ( 30 mg , once a day ) .


The treatment course lasted for 8 weeks .


Patients were assessed at baseline and at 2 , 4 , and 8 weeks .


Laboratory tests were performed at baseline , week 4 , and week 8 .


The data were analyzed using paired samples t-test or analysis of variance ( ANOVA ) .


A total of 115 patients was enrolled ( 58 TwHF ; 57 acitretin ) .


The median PASI score improved in the TwHF group by 50.4 % and in the acitretin group by 42.7 % .


There was no significant difference in median PASI improvement between two groups at 2 , 4 , and 8 weeks .


There was also no significant difference in PASI 25 , PASI 50 , PASI 75 , and PASI 90 response between the two groups at 2 , 4 , and 8 weeks .


There was a significant increase in the level of aspartate transaminase and triglycerides in the TwHF group ( P = 0.026 and P = 0.011 , respectively ) .


In the acitretin group , there was a significant increase in the level of alanine transaminase , cholesterol , and high-density lipoprotein ( P = 0.030 , P < 0.01 , and P < 0.01 , respectively ) .


There was no significant difference in treatment efficacy between the TwHF and acitretin groups within 8 weeks , but there were fewer treatment-related adverse events in the TwHF group .


Hypertension contributes to cardiovascular morbidity and mortality .


We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension .


We enrolled patients in this open-label , multicentre , prospective , randomised , controlled trial between October , 2012 , and April , 2014 .


Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment .


Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone ( control ) .


The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months .


Analysis was by modified intention to treat ( all patients remaining in follow-up at 6 months ) .


This trial is registered with ClinicalTrials.gov , number NCT01642498 .


83 ( 43 % ) of 195 patients screened were assigned arteriovenous coupler therapy ( n = 44 ) or normal care ( n = 39 ) .


Mean office systolic blood pressure reduced by 269 ( SD 239 ) mm Hg in the arteriovenous coupler group ( p < 00001 ) and by 37 ( 212 ) mm Hg in the control group ( p = 031 ) .


Mean systolic 24 h ambulatory blood pressure reduced by 135 ( 188 ) mm Hg ( p < 00001 ) in arteriovenous coupler recipients and by 05 ( 158 ) mm Hg ( p = 086 ) in controls .


Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 ( 29 % ) of 42 patients and was treatable with venoplasty or stenting .


Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications .


This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension .


ROX Medical .


To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction ( STEMI ) patients with serial optical frequency domain imaging ( OFDI ) investigations .


In a multi-centre study , 141 patients with ST elevation myocardial infarction < 12 h from onset were randomized to either PPCI with thrombectomy ( TB ) using an Eliminate catheter ( TB : n = 71 ) or without TB ( non-TB : n = 70 ) .


OFDI after drug-eluting stenting was performed using TERUMO OFDI system .


Per protocol , at follow-up 49 patients segments were reimaged .


At post-procedure and follow-up , there were no differences in stent and lumen areas between the two groups .


At follow-up , per strut-level analysis , percentage of incompletely apposed struts was 0.42 0.94 vs. 0.38 0.77 % ( P = 0.76 ) , and percentage of covered struts was 92.7 7.2 vs. 94.4 9.2 % ( P = 0.47 ) in the TB and non-TB groups , respectively .


There was a positive correlation between intra-stent structure ( ISS ) volume at post-procedure and the neointima volume at 6-month follow-up ( Pearson 's r = 0.409 , P = 0.04 ) .


Up to 12 months , there have been two and four patients having target vessel failure in the TB and in the non-TB groups , respectively .


In patients with STEMI , there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up .


However , ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up .


To investigate whether there is any effect resulting from preconditioning with nutraceutical supplementation containing arginine and oil mixes with high 9:6 ratio and low 6:3 ratio containing EPA and DHA , ALA fatty acids on inflammatory mediators , antioxidant and lipid profile modulation in surgical trauma .


Twenty-six men scheduled for radical prostatectomy were randomized into three groups and treated as follows : Group 1 ( skim milk , 0 % fat ) , Group 2 ( supplement with 6:3 ratio of 8:1 and arginine ) and Group 3 ( supplement with high 9:6 ratio of 3.2:1 and low 6:3 ratio of 1.4:1 and arginine ) .


Patients received skin milk or supplements twice a day ( 200 ml ) during five days prior to surgery .


Peripheral venous blood samples were collected at three different timepoints : five days before surgery ( PRE ) , before anesthesia induction ( IND ) and on the 2nd postoperative day ( POS ) .


Parameters analyzed included inflammatory cytokines ( IL-1 , IL-6 , IL-8 and TNF - ) , antioxidants ( catalase ) , lipid profile and heat shock protein ( HSP-27 ) .


There were no significant differences between groups on inflammatory mediators and antioxidant parameters .


However , lipid profile values ( Cholesterol , LDL , Triglycerides , VLDL ) , were significantly different .


Preconditioning with arginine and oil mixes containing high 9:6 ratio and low 6:3 ratio , has no effects on inflammatory mediators and oxidative stress in patients undergoing radical prostatectomy .


Reduction of cholesterol , triglycerides , LDL and VLDL profiles may be related to the trauma effect .


We tested the efficacy of a sexual risk-reduction intervention for men in South Africa , where heterosexual exposure is the main mode of HIV transmission .


Matched-pairs of neighborhoods in Eastern Cape Province , South Africa , were randomly selected and within pairs randomized to 1 of 2 interventions based on social cognitive theory and qualitative research : HIV/sexually transmitted infection ( STI ) risk-reduction , targeting condom use , or attention-matched control , targeting health issues unrelated to sexual risks .


Sexually active men aged 18 to 45 years were eligible .


The primary outcome was consistent condom use in the past 3 months .


Of 1181 participants , 1106 ( 93.6 % ) completed the 12-month follow-up .


HIV and STI risk-reduction participants had higher odds of reporting consistent condom use ( odds ratio [ OR ] = 1.32 ; 95 % confidence interval [ CI ] = 1.03 , 1.71 ) and condom use at last vaginal intercourse ( OR = 1.40 ; 95 % CI = 1.08 , 1.82 ) than did attention-control participants , adjusting for baseline prevalence .


No differences were observed on unprotected intercourse or multiple partnerships .


Findings did not differ for sex with steady as opposed to casual partners .


Behavioral interventions specifically targeting men can contribute to efforts to reduce sexual risk behaviors in South Africa .


Because of the deceased donor organ shortage , more kidney patients are considering whether to receive kidneys from family and friends , a process called living donor kidney transplantation ( LDKT ) .


Although Blacks and Hispanics are 3.4 and 1.5 times more likely , respectively , to develop end stage renal disease ( ESRD ) than Whites , they are less likely to receive LDKTs .


To address this disparity , a new randomized controlled trial ( RCT ) will assess whether Black , Hispanic , and White transplant patients ' knowledge , readiness to pursue LDKT , and receipt of LDKTs can be increased when they participate in the Your Path to Transplant ( YPT ) computer-tailored intervention .


Nine hundred Black , Hispanic , and White ESRD patients presenting for transplant evaluation at University of California , Los Angeles Kidney and Pancreas Transplant Program ( UCLA-KPTP ) will be randomly assigned to one of two education conditions , YPT or Usual Care Control Education ( UC ) .


As they undergo transplant evaluation , patients in the YPT condition will receive individually-tailored telephonic coaching sessions , feedback reports , video and print transplant education resources , and assistance with reducing any known socioeconomic barriers to LDKT .


Patients receiving UC will only receive transplant education provided by UCLA-KPTP .


Changes in transplant knowledge , readiness , pros and cons , and self-efficacy to pursue LDKT will be assessed prior to presenting at the transplant center ( baseline ) , during transplant evaluation , and 4 - and 8-months post-baseline , while completion of transplant evaluation and receipt of LDKTs will be assessed at 18-months post-baseline .


The RCT will determine , compared to UC , whether Black , Hispanic , and White patients receiving YPT increase in their readiness to pursue LDKT and transplant knowledge , and become more likely to complete transplant medical evaluation and pursue LDKT .


It will also examine how known patient , family , and healthcare system barriers to LDKT act alone and in combination with YPT to affect patients ' transplant decision-making and behavior .


Statistical analyses will be performed under an intent-to-treat approach .


At the conclusion of the study , we will have assessed the effectiveness of an innovative and cost-effective YPT intervention that could be utilized to tailor LDKT discussion and education based on the needs of individual patients of different races in many healthcare settings .


ClinicalTrials.gov , number NCT02181114 .


The aim of this study was to compare clinical outcomes , resource utilization , and health-related quality of life between Canadian and U.S. patients enrolled in ASCEND-HF ( Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ) .


A further aim was to supplement the within-trial analysis with a contemporaneous population-based comparison of all patients hospitalized with primary diagnoses of heart failure ( HF ) in the 2 countries .


Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States .


Trial patients consisted of 465 Canadian and 2,684 U.S. patients enrolled in ASCEND-HF .


Population-level cohorts consisted of 1.9 million U.S. and 81,016 Canadians hospitalized for HF in 2007 and2008 .


Canadian patients in ASCEND-HF were older , were more likely to be white , and had lower body weights and blood pressures than U.S. patients .


Canadians also had lower baseline-adjusted odds of 30-day mortality ( odds ratio : 0.46 ; 95 % confidence interval : 0.23 to 0.92 ) and better health-related quality of life than U.S. patients .


In both countries , trial patients differed significantly from population-level cohorts .


In contrast to ASCEND-HF , unadjusted in-hospital mortality at the population level was significantly lower in the United States ( 3.4 % ) compared with Canada ( 11.1 % ) ( p < 0.01 ) .


Intercountry differences in outcomes of patients hospitalized with HF differed significantly between trial and population cohorts .


Further study on how cardiac care is delivered in the 2 countries and how it influences the results of clinical trials and population-level outcomes , especially in the long term , is warranted .


( A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure ; NCT00475852 ) .


Roughly one in ten persons in the industrialized world suffers from hip osteoarthritis , a disease for which there is no cure .


The goal of conservative therapy is to relieve symptoms , preferably with methods that let patients assume responsibility for their own treatment , e.g. , physical training .


In a randomized controlled trial , we studied the effectiveness of twelve weeks of exercise therapy in patients with hip osteoarthritis ( THKo ) , compared to no treatment ( control group ) and placebo ultrasound treatment of the hip ( placebo ultrasound group ) .


The primary endpoint was a comparison of the pain scores of the intervention versus control groups on the generic SF-36 health questionnaire .


Secondary endpoints included comparisons across all three study groups of scores on the 7 other scales of the SF-36 and on the pain , physical function , and stiffness scales of the osteoarthritis-specific WOMAC Index .


The statistical analysis was performed with ANCOVA , with baseline values as a covariate .


Between-group effects were subsequently tested pairwise ( two-tailed t-tests , alpha = 0.05 ) .


As for the primary endpoint , pain reduction was significantly greater in the intervention than in the control group ( mean difference 5.7 points , 95 % confidence interval [ CI ] 0.4-11 .1 points , p = 0.034 ) .


The comparisons across all three study groups ( i.e. , secondary endpoints , with 71 subjects in the intervention group , 68 in the control group , and 70 in the placebo group ) revealed no significant between-group effects with respect to the SF-36 .


On the WOMAC Index , however , statistically significant differences were found for pain reduction between the intervention and control group ( mean difference 7.4 points , 95 % CI 3.0-11 .8 , p = 0.001 ) and between the intervention and placebo group ( mean difference 5.1 points , 95 % CI 0.7-9 .4 , p = 0.024 ) .


Comparable mean differences were also found for functional improvement .


Twelve weeks of exercise therapy in hip osteoarthritis patients of normal vitality reduced pain and improved physical function .


No significant improvement was found in these patients ' general health-related quality of life .


The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain .


Although the McKenzie method has been compared with several other interventions , it is not yet known whether this method is superior to placebo in patients with chronic low back pain .


The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain .


An assessor-blinded , 2-arm , randomized placebo-controlled trial will be conducted .


This study will be conducted in physical therapy clinics in So Paulo , Brazil .


The participants will be 148 patients seeking care for chronic nonspecific low back pain .


Participants will be randomly allocated to 1 of 2 treatment groups : ( 1 ) McKenzie method or ( 2 ) placebo therapy ( detuned ultrasound and shortwave therapy ) .


Each group will receive 10 sessions of 30 minutes each ( 2 sessions per week over 5 weeks ) .


The clinical outcomes will be obtained at the completion of treatment ( 5 weeks ) and at 3 , 6 , and 12 months after randomization .


The primary outcomes will be pain intensity ( measured with the Pain Numerical Rating Scale ) and disability ( measured with the Roland-Morris Disability Questionnaire ) at the completion of treatment .


The secondary outcomes will be pain intensity ; disability and function ; kinesiophobia and global perceived effect at 3 , 6 , and 12 months after randomization ; and kinesiophobia and global perceived effect at completion of treatment .


The data will be collected by a blinded assessor .


Therapists will not be blinded .


This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain .


The results of this study will contribute to better management of this population .


This study sought to evaluate the clinical relevance of potential clopidogrel drug-drug interactions .


Some studies have demonstrated that statins and calcium-channel blockers ( CCBs ) may attenuate the pharmacodynamic effects of clopidogrel .


The TRITON-TIMI 38 ( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 ) enrolled 13,608 patients with an acute coronary syndrome ( ACS ) and planned percutaneous coronary intervention ( PCI ) , and randomized them to clopidogrel or prasugrel .


Use of a statin or CCB was left to the discretion of the treating physician .


A multivariable Cox model with propensity score was employed to evaluate the association between statin or CCB use and clinical outcomes .


Of the 6,795 subjects assigned to clopidogrel , 4,794 ( 70.6 % ) were on a CYP3A4-metabolized statin , and 966 ( 14.2 % ) were on a CCB at randomization .


The risk of cardiovascular ( CV ) death , myocardial infarction ( MI ) , or stroke was similar regardless of baseline use of statins ( adjusted hazard ratio [ HR ] : 1.02 , 95 % confidence interval [ CI ] : 0.85 to 1.22 ) or CCBs ( adjusted HR : 1.16 ; 95 % CI : 0.94 to 1.43 ) in clopidogrel-treated patients .


Further , the combined use of a CCB and atorvastatin 80 mg daily ( adjusted HR : 0.82 ; 95 % CI : 0.37 to 1.84 ) , or a CCB , statin , and proton pump inhibitor ( adjusted HR : 1.04 ; 95 % CI : 0.70 to 1.54 ) were not associated with an increased risk of CV death , MI , or stroke .


The use of statins or CCBs did not modify the relative efficacy of prasugrel versus clopidogrel for the primary endpoint ( p for interaction = 0.43 , 0.55 , respectively ) .


In patients with ACS undergoing PCI , the use of statins or CCBs was not associated with an increased risk of CV events in clopidogrel-treated patients .


Consistent results were observed when the drugs were administered alone , together , or in combination with proton pump inhibitors .


This is a phase II multicentre study to investigate the efficacy and safety of avatrombopag ( E5501 ) , an investigational second-generation thrombopoietin receptor agonist , administered one week prior to elective procedures in patients with thrombocytopenia secondary to cirrhosis .


Adults with cirrhosis and platelet counts 10 to 5810 ( 9 ) / L were randomized to placebo or avatrombopag in two sequential cohorts .


Cohort A : placebo vs. one of 3 different doses ( 100mg loading dose followed by 20 , 40 , or 80 mg/day on days 2-7 ) of a first-generation avatrombopag formulation .


Cohort B : placebo vs. one of 2 different doses ( 80 mg loading dose followed by 10 mg/day for days 2-7 , or 20mg/day for days 2-4 ) of a second-generation avatrombopag formulation .


Primary end point was achievement of a platelet increase of 2010 ( 9 ) / L from baseline and > 5010 ( 9 ) / L at least once during days 4-8 .


A total of 130 patients were randomized : 93 patients ( 51 , cohort A ; 42 , cohort B ) to avatrombopag and 37 ( 16 , cohort A ; 21 cohort B ) to placebo .


The primary end point was achieved by 49.0 % of treated patients in cohort A and 47.6 % in cohort B compared to 6.3 % and 9.5 % of controls ; a dose response was seen .


Each avatrombopag regimen had a higher proportion of responders compared with their respective cohort placebo arms ( p < 0.01 ) , except for the 100/40 mg group in cohort A ( p = 0.17 ) .


The most common adverse events were nausea , fatigue , and headache .


One patient in the ( 100/80 ) avatrombopag group , without a Doppler assessment at screening was diagnosed with portal vein thrombosis during post-treatment follow-up .


In this study avatrombopag was generally well-tolerated and increased platelet counts in patients with cirrhosis undergoing elective invasive procedures .


Accessibility of the Internet allows obtaining information on different areas of life , including the impact of smoking , alcohol consumption and energy drinks on health .


Environmental exposure to tobacco smoke and active smoking are a serious risk for women 's health , especially for women in reproductive age and children at any time in their lives .


Alcohol is a risk factor for the development of general diseases , and consumed by pregnant women has a toxic effect on the body of women and a child in the prenatal period .


Due to the increased consumption of energy drinks containing among others nervous system stimulants and carbohydrates , their consumption should be a conscious choice of the consumers .


Knowledge of the health risks resulting from the lifestyle can be a decisive factor for the implementation of health behaviour .


The aim of the study was to determine the sources from which men and women acquire information concerning the effects of cigarette smoking , alcohol consumption and energy drinks on health .


The respondents interest in the above mentioned subjects was also evaluated .


The survey study was carried out in a group of 160 persons ( 114 women and 46 men ) , aged 19-60 years , randomly selected from the patients presenting to the Department of Conservative Dentistry with Endodontics of the Medical University of Lublin .


An author 's questionnaire was prepared for this research .


The data were analyzed statistically with the use of Pearson 's X2 test .


Statistically significant test values were those with p < 0.05 .


The internet was a source of information about the impact of smoking cigarettes on health for 52.63 % women and 56.52 % men , about the alcohol effect on health for 57.02 % women and 45.65 % men , while about energy drinks for 61.40 % of women and 47.83 % men .


Differences between sex of the respondents and indicated source of information were not statistically significant .


Obtaining information from television programmes on the impact of smoking on health reported 70.18 % of women and 63.04 % of men , about alcohol consumption - 66.67 % women and 58.70 % men respectively .


There was no statistically significant correlation between sex of the respondents and obtaining information concerning cigarette smoking and alcohol consumption .


Women showed significantly more frequently TV programmes as a source of information about energy drinks ( 61.40 % ) compared to males ( 43.48 % ) ( X2 = 4.28 , p < 0.05 ) .


Interest in the subject of the impact of smoking , alcohol consumption and energy drinks on health was not dependent on sex of the respondents .


Most women acquire knowledge about the effects of cigarette smoking , alcohol consumption and energy drinks on health from TV programmes , although the internet is an increasingly important source of information in this respect .


Despite depressive disorders being very common there has been little research to guide primary care physicians on the choice of treatment for patients with mild to moderate depression .


To evaluate the efficacy of interpersonal counselling compared with selective serotonin reuptake inhibitors ( SSRIs ) , in primary care attenders with major depression and to identify moderators of treatment outcome .


A randomised controlled trial in nine centres ( DEPICS , Australian New Zealand Clinical Trials Registry number : ACTRN12608000479303 ) .


The primary outcome was remission of the depressive episode ( defined as a Hamilton Rating Scale for Depression score 7 at 2 months ) .


Daily functioning was assessed using the Work and Social Adjustment Scale .


Logistic regression models were used to identify moderators of treatment outcome .


The percentage of patients who achieved remission at 2 months was significantly higher in the interpersonal counselling group compared with the SSRI group ( 58.7 % v. 45.1 % , P = 0.021 ) .


Five moderators of treatment outcome were found : depression severity , functional impairment , anxiety comorbidity , previous depressive episodes and smoking habit .


We identified some patient characteristics predicting a differential outcome with pharmacological and psychological interventions .


Should our results be confirmed in future studies , these characteristics will help clinicians to define criteria for first-line treatment of depression targeted to patients ' characteristics .


To identify distinct groups of patients with fibromyalgia ( FM ) with respect to multiple outcome measures .


Data from 631 duloxetine-treated women in 4 randomized , placebo-controlled trials were included in a cluster analysis based on outcomes after up to 12 weeks of treatment .


Corresponding classification rules were constructed using a classification tree method .


Probabilities for transitioning from baseline to Week 12 category were estimated for placebo and duloxetine patients ( Ntotal = 1188 ) using logistic regression .


Five clusters were identified , from `` worst '' ( high pain levels and severe mental/physical impairment ) to `` best '' ( low pain levels and nearly normal mental/physical function ) .


For patients with moderate overall severity , mental and physical symptoms were less correlated , resulting in 2 distinct clusters based on these 2 symptom domains .


Three key variables with threshold values were identified for classification of patients : Brief Pain Inventory ( BPI ) pain interference overall scores of < 3.29 and < 7.14 , respectively , a Fibromyalgia Impact Questionnaire ( FIQ ) interference with work score of < 2 , and an FIQ depression score of 5 .


Patient characteristics and frequencies per baseline category were similar between treatments ; > 80 % of patients were in the 3 worst categories .


Duloxetine patients were significantly more likely to improve after 12 weeks than placebo patients .


A sustained effect was seen with continued duloxetine treatment .


FM patients are heterogeneous and can be classified into distinct subgroups by simple descriptive rules derived from only 3 variables , which may guide individual patient management .


Duloxetine showed higher improvement rates than placebo and had a sustained effect beyond 12 weeks .


The symptoms of celiac disease ( CD ) are varied and metabolic bone disease ( MBD ) is less recognized amongst all manifestations in CD patients .


Bone disease in CD is attributed to secondary hyperparathyroidism , which in turn is associated with increased bone remodelling .


Improvement in bone mineral density ( BMD ) with gluten free diet ( GFD ) is known , but the data on efficacy of bisphosphonates in CD patients are limited .


Bisphosphonates being a potent inhibitor of bone resorption may be useful in patients with CD having low BMD .


The aim of the present investigation was to study the effect of zoledronic acid on BMD in CD patients .


A total of 28 CD patients were randomized to receive GFD , calcium and cholecalciferol ( group A ) , and zoledronic acid ( group B ) .


Baseline biochemical tests and T-score by dual energy x-ray absorptiometer were done and repeated after 12 months .


The T-score showed improvement in the control arm ( group A ) from -3.31 1.46 to -2.12 1.44 , a gain of 35.9 per cent ( P < 0.05 ) and in drug arm ( group B ) -2.82 1.27 to -1.06 1.84 , registering a gain of 62.4 per cent ( P < 0.001 ) .


However , there was no difference in improvement of T-score in zoledronic acid group as compared to the control group .


Administration of zoledronic acid was not found to be better than GFD alone in increasing BMD in CD patients with low BMD in this pilot study .


Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact .


Yet , few randomized controlled trials have tested this assumption .


The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors .


A randomized controlled trial was conducted with 3 tailoring conditions ( ie , sequential , simultaneous , and control conditions ) in the Netherlands in 2009-2012 .


Follow-up measurements took place after 12 and 24 months .


The intervention content was based on the I-Change model .


In a health risk appraisal , all respondents ( N = 5055 ) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity , vegetable consumption , fruit consumption , alcohol intake , and smoking .


Participants in the sequential ( n = 1736 ) and simultaneous ( n = 1638 ) conditions received tailored motivational feedback to change unhealthy behaviors one at a time ( sequential ) or all at the same time ( simultaneous ) .


Mixed model analyses were performed as primary analyses ; regression analyses were done as sensitivity analyses .


An overall risk score was used as outcome measure , then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention .


Both tailoring strategies were associated with small self-reported behavioral changes .


The sequential condition had the most significant effects compared to the control condition after 12 months ( T1 , effect size = 0.28 ) .


After 24 months ( T2 ) , the simultaneous condition was most effective ( effect size = 0.18 ) .


All 5 individual lifestyle behaviors changed over time , but few effects differed significantly between the conditions .


At both follow-ups , the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition ( T1 effect size = 0.31 ; T2 effect size = 0.41 ) .


The sequential condition was more effective in decreasing alcohol consumption than the control condition at 24 months ( effect size = 0.27 ) .


Change was predicted by the amount of exposure to the intervention ( total visiting time : beta = -.06 ; P = .01 ; total number of visits : beta = -.11 ; P < .001 ) .


Both interventions were appreciated well by respondents without significant differences between conditions .


Although evidence was found for the effectiveness of both programs , no simple conclusive finding could be drawn about which intervention mode was more effective .


The best kind of intervention may depend on the behavior that is targeted or on personal preferences and motivation .


Further research is needed to identify moderators of intervention effectiveness .


The results need to be interpreted in view of the high and selective dropout rates , multiple comparisons , and modest effect sizes .


However , a large number of people were reached at low cost and behavioral change was achieved after 2 years .


Nederlands Trial Register : NTR 2168 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 ( Archived by WebCite at http://www.webcitation.org/6MbUqttYB ) .


Very few data exist on the long-term follow-up of patients with intermediate nonobstructive saphenous vein graft ( SVG ) lesions .


The purpose of this study was to evaluate the 5-year clinical outcomes of the patients enrolled in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound ( VELETI ) and the factors associated with SVG disease progression and outcomes .


Patients with 1 intermediate SVG lesion ( 30 % -60 % diameter stenosis ) were randomized to either stenting the SVG lesion with a paclitaxel-eluting stent ( PES group , n = 30 ) or to medical treatment alone ( MT group , n = 27 ) .


All patients were followed yearly up to 5 years .


Major adverse cardiac events ( MACEs ) ( cardiac death , myocardial infarction [ MI ] , revascularization ) related to the target SVG lesion tended to be lower in the PES group ( 17 % vs 33 % ; P = 0.146 ) due to a lower lesion revascularization rate ( 13 % vs 33 % ; P = 0.072 ) , with no difference in cardiac death or MI between groups .


MACEs related to the target SVG and global MACEs were similar between groups ( P > 0.20 for both ) .


A higher cholesterol level at baseline was the only independent predictive factor of MACEs related to the target SVG ( P = 0.016 ) .


Over a 5-year period , one third of intermediate lesions in old SVGs progressed , leading to a cardiac event .


Stenting these lesions with PESs tended to improve clinical outcomes by reducing lesion progression but not SVG failure .


Higher cholesterol levels were associated with SVG disease progression and clinical events .


This pilot study provides the basis for a larger trial to determine the efficacy of intermediate SVG lesion plaque sealing .


Airway management is crucial in clinical anesthesia .


Many complications associated with airway management result from unexpected difficult airway , but predicting a difficult airway is a major challenge .


We investigated the efficacy of a new combined model including radiological indicators to predict difficult airway in patients undergoing surgery for cervical spondylosis , a population with a high incidence of difficult airway .


We randomly enrolled 303 patients scheduled for elective surgery for cervical spondylosis at Peking University Third Hospital between August 2012 and March 2013 .


Preoperatively , patients were evaluated for difficult airway according to a clinical index and parameters on lateral cervical radiographs and magnetic resonance images .


Difficult airway was defined as Cormack-Lehane grades III-IV .


Logistic regression was used to identify a combined ( clinical and radiological ) model for difficult airway .


A receiver operating characteristic ( ROC ) curve was used to describe the effectiveness of prediction .


We identified three clinical predictive factors using the ROC curve : mouth opening , sternomental distance , and neck mobility .


We created a clinical model using three factors : gender , age , and mouth opening , with odds ratios ( OR ) of 0.370 , 1.034 , and 0.358 , respectively .


Using the clinical and radiological parameters , we formulated a combined model with five risk factors : gender , mouth opening , atlanto-occipital gap , the angle from the second to sixth cervical vertebraes in the neutral position , and the angle difference of d ( the angle between the laryngeal axis and the epiglottic axis ) from the neutral position to extension ( OR : 0.107 , 0.355 , 0.846 , 1.057 , and 0.952 , respectively ) .


The sensitivity and specificity of the combined model were 80.0 % and 65.7 % , respectively , and the ROC curve confirmed that the combined model was better than any single clinical predictor and the clinical model .


The efficacy of the combined model including both clinical and radiological indicators was better than any single clinical predictor or the clinical model in patients undergoing elective surgery for cervical spondylosis .


In medical settings , motivational interviewing-based `` brief intervention '' ( BI ) counseling reduces alcohol-related risk-taking behavior and harm in high-risk populations .


Individuals arrested for driving under the influence of alcohol ( DUI ) are another at-risk population .


We sought to determine whether a BI administered shortly after a first DUI arrest might decrease problematic drinking behavior .


We conducted a single-center , parallel-group , double-blinded superiority randomized trial ( NCT01270217 ) , enrolling first-time DUI arrestees at a county jail from December 2010 through April 2011 .


Before their release , we randomized participants by computer-generated sequence to either a single BI or no discussion .


We assessed 90-day change in Alcohol Use Disorders Identification Test ( AUDIT ) scores ( range 0-40 , higher values indicating more problematic drinking ) as the primary outcome .


We enrolled 200 subjects ( 100 to each arm ) , and 181 ( 90.5 % , 86 control and 95 BI ) completed the 90-day follow-up .


Mean ( SD ) age was 30 ( 10 ) years , and 50 % were men .


Mean ( SD ) blood alcohol concentration upon arrest was 0.14 % ( 0.04 % ) .


Mean ( SD ) baseline AUDIT scores were 8.8 ( 5.8 ) among control subjects and 7.7 ( 6.3 ) among BI subjects .


At 90 days , AUDIT scores decreased by a mean ( SD ) 4.7 ( 5.1 ) units among control subjects and 3.4 ( 5.0 ) among BI subjects ( difference , -1.3 ; 95 % confidence interval [ CI ] , -2.8 to +0.1 ) .


The likelihood of subsequent binge drinking [ relative risk ( RR ) 1.6 ; 95 % CI , 0.8-3 .0 ; BI vs. control ] , abstinence ( RR , 0.9 ; 95 % CI , 0.4-2 .1 ) , alcohol-related injury to self or others ( RR , 0.4 ; 95 % CI , 0.1-2 .4 ) , and seeking treatment ( RR , 1.2 ; 95 % CI , 0.8-1 .7 ) did not differ .


A single BI counseling session shortly after first-time DUI arrest does not reduce 90-day self-reported drinking behavior or increase seeking treatment for drinking beyond that which occurs without such a discussion .


Therapeutic study , level III .


This randomized open-label phase II study evaluated the efficacy , safety , and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated , advanced , nonsquamous non-small-cell lung cancer .


Patients were randomized ( 2:1 ratio ) to receive pemetrexed 500 mg/m ( 2 ) intravenously once every 3 weeks plus either oral pazopanib 800 mg daily or cisplatin 75 mg/m ( 2 ) intravenously once every 3 weeks up to six cycles .


All patients received folic acid , vitamin B12 , and steroid prophylaxis .


The primary endpoint was progression-free survival ( PFS ) .


The study was terminated after 106 of 150 patients were randomized due to a higher incidence of adverse events leading to withdrawal from the study and severe and fatal adverse events in the pazopanib/pemetrexed arm than in the cisplatin/pemetrexed arm .


At the time enrolment was discontinued , there were three fatal adverse events in the pazopanib/pemetrexed arm , including ileus , tumor embolism , and bronchopneumonia/sepsis .


Treatment with pazopanib/pemetrexed was discontinued resulting in more PFS data censored for patients in the pazopanib/pemetrexed arm than those in the cisplatin/pemetrexed arm .


There was no statistically significant difference between the pazopanib/pemetrexed and cisplatin/pemetrexed arms for PFS ( median PFS , 25.0 versus 22.9 weeks , respectively ; hazard ratio = 0.75 ; 95 % confidence interval , 0.43 % -1.28 % ; p = 0.26 ) or objective response rate ( 23 % versus 34 % , respectively ; 95 % confidence interval , -30.6 % to 7.2 % ; p = 0.21 ) .


The combination of pazopanib/pemetrexed in first-line treatment of non-small-cell lung cancer showed some antitumor activity but had unacceptable levels of toxicity .


This study aims to explore the temporal relationship between age of onset of substance use and criminal activity in women convicted of violent crimes as well as to subdivide them into clinically significant groups to which tailored treatment can be guided .


Of the 353 female inmates randomised for this study , 38 ( 10.8 % ) refused to participate and 182 ( 51.6 % ) met inclusion criteria .


Data were obtained only from substance-abusing female inmates serving a sentence for robbery or homicide in a female penitentiary in Brazil .


Participant information was gathered through face-to-face interviews during which alcohol and drug abuse , impulsiveness levels , depressive symptoms , and criminological aspects were investigated .


Age of first alcohol and drug use significantly preceded the age of onset of criminal activities in the overall sample .


Onset ages of alcohol and drug use problems significantly preceded the beginning of criminal activities in women convicted of homicide only .


Latent Class Analysis resulted in two groups : cluster 1 ( n = 122 ; 67 % ) , early-onset alcohol and drug users ; and cluster 2 ( n = 60 ; 33 % ) , late-onset alcohol and drug users .


Higher depression levels , higher incidence of committing robbery and less official history of recidivism were associated with cluster 1 inmates .


The temporal relationship between the onset age of alcohol/drug use problems and age of the beginning of criminal activities can set apart women convicted of robbery from those convicted of homicide .


Further , a distinctive therapeutic approach to early - and late-onset offenders may be valuable .


Previous studies suggest cross-sectional associations between a diagnosis of chronic obstructive pulmonary disease ( COPD ) and mild cognitive impairment ( MCI ) .


However , few studies have assessed whether COPD , a potentially modifiable factor , is associated with an increased risk for MCI and whether the relation is specific to the type of MCI .


To investigate whether a diagnosis of COPD and duration of COPD are associated with an increased risk for incident MCI and MCI subtypes ( amnestic MCI [ A-MCI ] and nonamnestic MCI [ NA-MCI ] ) .


A prospective population-based cohort from the Mayo Clinic Study on Aging .


We included 1425 cognitively normal individuals aged 70 to 89 years who were randomly selected from Olmsted County , Minnesota , on October 1 , 2004 , using the medical records linkage system .


At baseline and every 15 months thereafter , participants underwent assessment with a nurse interview , neurologic examination , and neuropsychological testing .


A diagnosis of COPD was confirmed via medical record review .


A baseline diagnosis of COPD and duration of COPD were examined as risk factors for MCI and MCI subtypes using Cox proportional hazards models and adjusting for demographic variables and medical comorbidities , with age as the time scale .


A baseline diagnosis of COPD and duration of COPD .


Incident MCI , A-MCI , and NA-MCI .


Of the 1425 participants with normal cognition at baseline , 370 developed incident MCI .


The median duration of follow-up was 5.1 years ( interquartile range , 3.8-5 .4 years ) .


A diagnosis of COPD significantly increased the risk for NA-MCI by 83 % ( hazard ratio , 1.83 [ 95 % CI , 1.04-3 .23 ] ) , but not of any MCI or A-MCI in multivariate analyses .


We found a dose-response relationship such that individuals with COPD duration of longer than 5 years at baseline had the greatest risk for any MCI ( hazard ratio , 1.58 [ 95 % CI , 1.04-2 .40 ] ) and NA-MCI ( 2.58 [ 1.32-5 .06 ] ) .


A diagnosis of COPD is associated with an increased risk for MCI , particularly NA-MCI .


We have found a dose-response relationship between COPD duration and risk for MCI .


These findings highlight the importance of COPD as a risk factor for MCI and may provide a substrate for early intervention to prevent or delay the onset and progression of MCI , particularly NA-MCI .


Lung cancer screening programs may provide opportunities to reduce smoking rates among participants .


This study evaluates the impact of lung cancer screening results on smoking cessation .


Data from Lung Screening Study participants in the National Lung Screening Trial ( NLST ; 2002-2009 ) were used to prepare multivariable longitudinal regression models predicting annual smoking cessation in those who were current smokers at study entry ( n = 15489 , excluding those developing lung cancer in follow-up ) .


The associations of lung cancer screening results on smoking cessation over the trial period were analyzed .


All hypothesis testing used two sided P values .


In adjusted analyses , smoking cessation was strongly associated with the amount of abnormality observed in the previous year 's screening ( P < .0001 ) .


Compared with those with a normal screen , individuals were less likely to be smokers if their previous year 's screen had a major abnormality that was not suspicious for lung cancer ( odds ratio [ OR ] = 0.811 ; 95 % confidence interval [ CI ] = 0.722 to 0.912 ; P < .001 ) , was suspicious for lung cancer but stable from previous screens ( OR = 0.785 ; 95 % CI = 0.706 to 0.872 ; P < .001 ) , or was suspicious for lung cancer and was new or changed from the previous screen ( OR = 0.663 ; 95 % CI = 0.607 to 0.724 ; P < .001 ) .


Differences in smoking prevalence were present up to 5 years after the last screen .


Smoking cessation is statistically significantly associated with screen-detected abnormality .


Integration of effective smoking cessation programs within screening programs should lead to further reduction in smoking-related morbidity and mortality .


To determine the impact of a vaccination reminder in an electronic health record supplemented with data from an immunization information system ( IIS ) .


A noninterruptive influenza vaccination reminder , based on a real-time query of hospital and city IIS , was used at 4 urban , academically affiliated clinics serving a low-income population .


Using a randomized cluster-crossover design , each study site had `` on '' and `` off '' period during the fall and winter of 2011-2012 .


Influenza vaccination during a clinic visit was assessed for 6-month to 17-year-old patients .


To assess sustainability , the reminder was active at all sites during the 2012-2013 season .


In the 2011-2012 season , 8481 unique non-up-to-date children had visits .


Slightly more non-up-to-date children seen when the reminder was ` on ' were vaccinated than when ` off ' ( 76.2 % vs 73.8 % ; P = .027 ) .


Effects were seen in the winter ( 67.9 % vs 62.2 % ; P = .005 ) , not fall ( 76.8 % vs 76.5 % ) .


The reminder also increased documentation of the reason for vaccine non-administration ( 68.1 % vs 41.5 % ; P < .0001 ) .


During the 2011-2012 season , the reminder displayed for 8630 unique visits , and clinicians interacted with it in 83.1 % of cases where patients required vaccination .


During the 2012-2013 season , it displayed for 22248 unique visits ; clinicians interacted with it in 84.8 % of cases .


An IIS-linked influenza vaccination reminder increased vaccination later in the winter when fewer vaccine doses are usually given .


Although the reminder did not require clinicians to interact with it , they frequently did ; utilization did not wane over time .


Parenting programs have been highlighted as a way of supporting and empowering parents .


As programs designed to promote children 's health and well-being are scarce , a new health-promotion program , All Children in Focus , has been developed .


The purpose of this trial was to evaluate the potential effectiveness of the program in promoting parental self-efficacy and child health and development , as well as to investigate possible moderators of these outcomes .


A multicenter randomized waitlist-controlled trial was conducted .


The trial included 621 parents with children aged 3-12 years .


Parents were randomized to receive the intervention directly or to join a waitlist control group .


Parents completed questionnaires at baseline , 2weeks after the intervention , and 6months post-baseline .


To evaluate potential effects of the program , as well as any moderating variables , multilevel modeling with a repeated-measures design was applied .


Parents in the intervention group reported that their self-efficacy ( p < .001 ) , as well as their perceptions of children 's health and development ( p < .05 ) , increased 6months post-baseline when compared with parents in the control group .


One variable was found to moderate both outcomes : parents ' positive mental health .


Furthermore , parents ' educational level and number of children moderated parental self-efficacy , while the children 's age moderated child health and development .


Having a poor positive mental health , a university-level education , more than one child in the family , and older children , made the families benefit more .


In the first randomized controlled trial of All Children in Focus , we found that the program appears to promote both parental self-efficacy and children 's health and development in a general population .


Additionally , we found that families may benefit differently depending on their baseline characteristics .


This contributes to an existing understanding of the advantages of offering universal parenting programs as a public health approach to strengthening families .


However , further research is needed to investigate long-term effects and mediating variables , as well as the potential cost-effectiveness of the program .


Current Controlled Trials : ISRCTN70202532 .


November 7th 2012 .


Given the rising number of strokes worldwide , and the large number of individuals left with disabilities after stroke , novel strategies to reduce disability , increase functions in the motor and the cognitive domains , and improve quality of life are of major importance .


Physical activity is a promising intervention to address these challenges but , as yet , there is no study demonstrating definite outcomes .


Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes , in particular gait speed and the Barthel Index ( co-primary outcome measures ) reflecting activities of daily living ( ADL ) .


We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach .


Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45days after stroke onset .


Participants will be stratified for the prognostic variables of `` centre '' , `` age '' , and `` stroke severity '' , and randomly assigned to one of two groups .


The interventional group receives physical fitness training delivered as supported or unsupported treadmill training ( cardiovascular active aerobic training ; five times per week , over 4weeks ; each session 50minutes ; total of 20 additional physical fitness training sessions ) in addition to standard rehabilitation treatment .


The control intervention consists of relaxation sessions ( non-cardiovascular active ; five times per week week , over 4weeks ; each session 50minutes ) in addition to standard rehabilitation treatment .


Co-primary efficacy endpoints will be gait speed ( in m/s , 10m walk ) and the Barthel Index ( 100 points total ) at 3months post-stroke , compared to baseline measurements .


Secondary outcomes include standard measures of quality of life , sleep and mood , cognition , arm function , maximal oxygen uptake , and cardiovascular risk factors including blood pressure , pulse , waist-to-hip ratio , markers of inflammation , immunity and the insulin-glucose pathway , lipid profile , and others .


The goal of this endpoint-blinded , phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes , and to elucidate the mechanisms underlying this intervention .


Registered in ClinicalTrials.gov with the Identifier NCT01953549 .


Community engagement ( CE ) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes .


Given the potential importance of CE , but also complexities and possibility of unexpected negative outcomes , there is need for more documentation of CE processes in practice .


We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County , Kenya .


Social scientists independent of the trial held in-depth individual interviews with trial researchers ( n = 5 ) , community leaders ( n = 8 ) and parents ( 15 with enrolled children and 4 without ) ; and group discussions with fieldworkers ( n = 6 ) and facility staff ( n = 2 ) .


We conducted a survey of participating households ( n = 200 ) and observed over 150 CE activities .


The overall CE plan was similar across the three study sites , although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions ; increase visibility , awareness of and trust in trial staff .


Challenges included : some community leaders attempting to exert pressure on people to enrol ; local wording in information sheets and consent forms feeding into serious anxieties about the trial ; and concerns about reduced CE over time .


Negative effects of these challenges were mitigated through changes to on-going CE activities , and final information sharing and consent being conducted individually by trained clinical staff .


One year after enrolment , 31 % ( n = 62 ) of participants ' parents reported malaria prevention as the main aim of the activities their children were involved in , and 93 % wanted their children to remain involved .


The trial teams ' goals for CE were relatively clear from the outset .


Other actors ' hopes and expectations ( like higher allowances and future employment ) were not openly discussed , but emerged over the course of engagements .


Encouraging open discussion of all actors ' intentions and goals from the outset takes time , risks raising expectations that can not be met , and is complex .


However , doing so in future similar trials may allow successes here to be built upon , and some challenges minimized or avoided .


ClinicalTrials.gov NCT00866619 ( registration 19-Mar-2009 ) .


Analysis via computed tomography imaging software .


To determine parameters for ideal intralaminar screw trajectory and the feasibility of screw placement at L3 , L4 , and L5 laminae for pars defect fixation .


To our knowledge , no studies provide anatomic parameters for ideal intralaminar screw trajectory for treating spondylolysis .


We used advanced imaging software for 3-dimensional interactive viewing to analyze 20 randomly selected normal adolescent lumbar computed tomographic scans .


The ideal intralaminar screw trajectory was drawn from the inferior lamina , a point chosen to maximize cortical diameter at the isthmus of the lamina and bisect the pedicle .


We measured and evaluated ideal trajectory parameters for percutaneous screw placement for pars defect fixation at the L3 to L5 laminae .


The ideal pathway was the thick portion of the lamina between the inferior edge of the lamina and the pedicle .


This area was close to the inferior articular process ( axial plane ) , becoming more so at progressively caudal levels .


At the ideal trajectory , the mean ( standard deviation ) coronal angle slightly decreased ( L3-L5 ) : 7.3 ( 5.1 ) , 6.6 ( 3.7 ) , and 4.2 ( 2.5 ) , respectively .


The trajectory distance increased from cranial to caudal .


These parameters increased ( L3-L5 ) : mean distance ( transverse plane ) between the starting point and middle of the spinous process , 1.2 ( 0.18 cm ) , 1.3 ( 0.2 cm ) , and 1.6 ( 0.3 cm ) , respectively ; mean screw sagittal angle with respect to the posterior skin , 15.5 ( 5.0 ) , 24.3 ( 6.5 ) , and 43 ( 5.8 ) , respectively ; and mean distance for guide wire entry , 28.8 ( 10.6 cm ) , 20.1 ( 5.4 cm ) , and 11.9 ( 2.1 cm ) , respectively .