Tenofovir disoproxil fumarate ( TDF ) use has been associated with declines in the estimated glomerular filtration rate ( eGFR ) when used as part of antiretroviral treatment by persons with human immunodeficiency virus ( HIV ) type @ , but limited data are available for risk when used as preexposure prophylaxis ( PrEP ) for HIV-@ prevention .


To determine whether TDF-based PrEP causes eGFR decline in HIV-@-uninfected adults .


A per-protocol safety analysis of changes in eGFR in the Partners PrEP Study , a randomized , placebo-controlled trial of daily oral TDF and emtricitabine ( FTC ) - TDF PrEP among heterosexual HIV-@-uninfected members of serodiscordant couples in Kenya and Uganda .


The trial was conducted from @ to @ .


Predefined outcomes of this analysis were mean eGFR change and a @ % or greater eGFR decline from baseline .


The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation .


Of @ participants in the once-daily TDF ( n = @ ) , FTC-TDF ( n = @ ) , or placebo ( n = @ ) groups , @ % were men .


At enrollment , median age was @ years ( range , @-@ years ) , and mean eGFR was @ mL/min/@ @ m.


During a median follow-up of @ months ( interquartile range @-@ months ) , mean within-group eGFR change from baseline was +@ mL/min/@ @ m for TDF , -@ mL/min/@ @ m for FTC-TDF , and +@ mL/min/@ @ m for placebo , translating into average declines in eGFR attributable to PrEP vs placebo of -@ mL/min/@ @ m ( @ % CI , -@ to -@ ; P = @ ) for TDF and -@ mL/min/@ @ m ( @ % CI , -@ to -@ ; P < @ ) for FTC-TDF .


The difference in mean eGFR between PrEP and placebo appeared by @ month after randomization , was stable through @ months , and then appeared to wane thereafter .


The respective proportions of persons who developed a confirmed @ % or greater eGFR decline from baseline by @ and @ months was @ % and @ % for TDF and @ % and @ % for FTC-TDF , and these frequencies were not statistically different from the confirmed decline in the placebo group ( @ % and @ % by @ and @ months , respectively ) .


In this large randomized , placebo-controlled trial among heterosexual persons , with median follow-up of @ months and maximum follow-up of @ months , daily oral TDF-based PrEP resulted in a small but nonprogressive decline in eGFR that was not accompanied by a substantial increase in the risk of clinically relevant ( @ % ) eGFR decline .


Patients hospitalized for acute decompensated heart failure ( ADHF ) are at high risk for early mortality and rehospitalization .


Risk stratification of ADHF using clinically available data on admission is increasingly important to integrate with clinical pathways .


Our goal was to create a simple method of screening patients upon admission to identify those with increased risk of future adverse events .


Using ASCEND-HF , a pragmatic clinical trial conducted in @ sites globally , we developed and validated logistic regression risk models for ( a ) @-day mortality/HF rehospitalization , ( b ) @-day mortality/all-cause rehospitalization , ( c ) @-day all-cause mortality , and ( d ) @-day all-cause mortality .


Fifty-one candidate variables were evaluated based on prior publications and clinical review .


Final models were selected based on stepwise selection with entry and a staying criterion of P < @ .


The @-day mortality model was externally validated , and coefficients were converted to an additive risk score .


Among @,@ patients , the median age was @ years , @ % were female , and @ % had a left ventricular ejection fraction < @ % .


The models had between @ and @ risk factors with c-indices ranging from @ to @ .


A simplified score , including age , systolic blood pressure , sodium , blood urea nitrogen , and dyspnea at rest , discriminated @-day mortality risk from @ % ( score @ ) to @ % ( score @ ) .


Commonly available clinical variables provide simple risk stratification for clinical outcomes among patients with ADHF , and these models may be considered for integration into routine clinical care .


Ciliary neurotrophic factor ( CNTF ) protects rod photoreceptors from retinal degenerative disease in multiple nonhuman models .


Thus far , CNTF has failed to demonstrate rod protection in trials for human retinitis pigmentosa .


Recently , CNTF was found to improve cone photoreceptor function in a canine CNGB@ achromatopsia model .


This study explores whether this finding translates to humans with CNGB@ achromatopsia .


A five-subject , open-label Phase I/II study was initiated by implanting intraocular microcapsules releasing CNTF ( nominally @ ng/d ) into one eye each of CNGB@ achromat participants .


Fellow eyes served as untreated controls .


Subjects were followed for @ year .


Pupil constriction in treated eyes gave evidence of intraocular CNTF release .


Additionally , scotopic ERG responses were reduced , and dark-adapted psychophysical absolute thresholds were increased , attributable to diminished rod or rod pathway activity .


Optical coherence tomography revealed that the cone-rich fovea underwent structural changes as the foveal hyporeflective zone ( HRZ ) became diminished in CNTF-treated eyes .


No objectively measurable enhancement of cone function was found by assessments of visual acuity , mesopic increment sensitivity threshold , or the photopic ERG .


Careful measurements of color hue discrimination showed no change .


Nonetheless , subjects reported beneficial changes of visual function in the treated eyes , including reduced light sensitivity and aversion to bright light , which may trace to decreased effective ambient light from the pupillary constriction ; further they noted slowed adaptation to darkness , consistent with CNTF action on rod photoreceptors .


Ciliary neurotrophic factor did not measurably enhance cone function , which reveals a species difference between human and canine CNGB@ cones in response to CNTF .


( ClinicalTrials.gov number , NCT@ . )


SRT@ is a selective activator of SIRT@ .


In animal models , SRT@ improves glucose homeostasis and increases insulin sensitivity .


We evaluated the tolerability and pharmacokinetics of SRT@ , and its effects on glycaemic control , in adults with type @ diabetes mellitus .


Type @ diabetics with glycosylated haemoglobin ( HbA@c ) @ % and @ % , fasting glucose @ and @mgdl ( -@ ) , and on stable doses of metformin were evenly randomized to placebo or SRT@ @ g , @ g , @ g or @ g , administered orally once daily for @days .


Changes in fasting and post-prandial glucose and insulin were analyzed .


Safety evaluation found no major differences between groups in the frequency of adverse events .


SRT@ concentrations did not increase in a dose-proportional fashion .


Significant variability in exposure was observed .


Treatment with SRT@ did not lead to any consistent , dose-related changes in glucose or insulin .


Day @ change from baseline ( mean ( SD ) ) : fasting glucose ( mmoll ( -@ ) ) = -@ ( @ ) , -@ ( @ ) , -@ ( @ ) , -@ ( @ ) and -@ ( @ ) for placebo , @ g , @ g , @ g and @ g , respectively .


Day @ change from baseline ( mean ( SD ) ) : fasting insulin ( mmoll ( -@ ) ) = @ ( @ ) , @ ( @ ) , -@ ( @ ) , @ ( @ ) and @ ( @ ) for placebo , @ g , @ g , @ g and @ g , respectively ) Treatment with SRT@ was associated with improvement in lipid profiles .


Treatment with SRT@ for @days did not result in improved glucose or insulin control which is likely due to the observed pharmacokinetics which were not dose proportional and had large between subject variability .


We examined the degree of postprandial triglyceride ( TG ) response over the day , representing a highly dynamic state , with continuous metabolic adaptations , among normal-weight , overweight and obese patients , according to their metabolically healthy or abnormal status .


A total of @ patients from the CORDIOPREV clinical trial ( NCT@ ) were submitted to an oral fat load test meal with @ g fat/kg body weight ( @ % saturated fatty acids ( SFA ) , @ % polyunsaturated fatty acids ( PUFA ) , @ % monounsaturated fatty acids ( MUFA ) , @ % protein and @ % carbohydrates ) .


Serial blood test analysing lipid fractions and inflammation markers ( high-sensitivity C-reactive protein ( hs-CRP ) ) were drawn at @ , @ , @ , @ and @ h during postprandial state .


We explored the dynamic response according to six body size phenotypes : ( i ) normal weight , metabolically healthy ; ( ii ) normal weight , metabolically abnormal ; ( iii ) overweight , metabolically healthy ; ( iv ) overweight , metabolically abnormal ; ( v ) obese , metabolically healthy ; and ( vi ) obese , metabolically abnormal .


Metabolically healthy patients displayed lower postprandial response of plasma TG and large triacylglycerol-rich lipoproteins ( TRLs ) - TG , compared with those metabolically abnormal , independently whether or not they were obese ( P < @ and P < @ , respectively ) .


Moreover , the area under the curve ( AUC ) of TG and AUC of large TRLs-TG were greater in the group of metabolically abnormal compared with the group of metabolically healthy ( P < @ and P < @ , respectively ) .


Interestingly , metabolically abnormal subjects displayed higher postprandial response of plasma hs-CRP than did the subgroup of normal , overweight and obese , metabolically healthy patients ( P < @ ) .


Our findings showed that certain types of the metabolic phenotypes of obesity are more favourable modulating phenotypic flexibility after a dynamic fat load test , through TG metabolism and inflammation homoeostasis .


To identify , these phenotypes may be the best strategy for personalized treatment of obesity .


No therapy has been proven to prevent the recurrence of diverticulitis .


Mesalamine has shown efficacy in preventing relapse in inflammatory bowel disease , and there is preliminary evidence that it might be effective for diverticular disease .


We investigated the efficacy of mesalamine in preventing recurrence of diverticulitis in @ identical but separate phase @ , randomized , double-blind , placebo-controlled , multicenter trials ( identical confirmatory trials were conducted for regulatory reasons ) .


We evaluated the efficacy and safety of multimatrix mesalamine vs placebo in the prevention of recurrent diverticulitis in @ ( PREVENT@ ) and @ ( PREVENT@ ) adult patients with @ episodes of acute diverticulitis in the previous @ months that resolved without surgery .


Patients received mesalamine ( @ g , @ g , or @ g ) or placebo once daily for @ weeks .


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


Diverticulitis recurrence was defined as surgical intervention at any time for diverticular disease or presence of computed tomography scan results demonstrating bowel wall thickening ( > @ 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 @ .


Among patients in PREVENT@ , @ % -@ % did not have disease recurrence , compared with @ % of those given placebo .


Among patients in PREVENT@ , @ % -@ % of patients did not have disease recurrence , compared with @ % 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 : NCT@ and NCT@ .


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 @ 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 @ mechanisms on cerebral autoregulation and whether they can fully explain it .


Sympathetic , cholinergic , and myogenic mechanisms together accounted for @ % of the cerebral pressure-flow relationship ( P < @ ) , with significant and distinct contributions from each of the @ 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 @ % 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 @ children with unilateral CP ( @ males , @ females ; mean age @y @mo -LSB- SD @y @mo ; range @-@y -RSB- ; Manual Ability Classification System -LSB- MACS -RSB- level I = @ ; level II = @ ; level III = @ ) .


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


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 @ % of the variance in AMPS motor scale scores .


TVPS-@ Visual Sequential Memory , TVPS-@ Visual Closure , and JTTHF dominant upper limb score together explained @ % 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 @ , randomised SIOP WT @ trial , we recruited children aged @ months to @ years at the time of diagnosis of a primary renal tumour from @ hospitals in @ countries who had received @ 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 ( @:@ ) by a minimisation technique to receive vincristine @ mg/m ( @ ) at weeks @-@ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ , plus actinomycin D @ g/kg every @ weeks from week @ , either with five doses of doxorubicin @ mg/m ( @ ) given every @ weeks from week @ ( standard treatment ) or without doxorubicin ( experimental treatment ) .


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


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


This trial is registered with EudraCT , number @-@-@ , and is closed to new participants .


Between Nov @ , @ , and Dec @ , @ , we recruited @ patients , @ with stage II and @ with stage III tumours , and randomly assigned @ children to treatment including doxorubicin , and @ children to treatment excluding doxorubicin .


Median follow-up was @ months ( IQR @-@ ) .


@ year event-free survival was @ % ( @ % CI @-@ ) for treatment including doxorubicin and @ % ( @-@ ) for treatment excluding doxorubicin , a difference of @ % ( @ % CI @-@ ) that did not exceed the predefined @ % margin .


@ year overall survival was @ % ( @-@ ) for treatment including doxorubicin and @ % ( @-@ ) for treatment excluding doxorubicin .


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


@ patients ( @ % ) had hepatic veno-occlusive disease .


Cardiotoxic effects were reported in @ ( @ % ) of @ children receiving treatment including doxorubicin .


@ 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 .


The aim of this study was to compare the effect of pioglitazone with glimepiride on coronary arterial inflammation with serial ( @ ) 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 @ diabetes mellitus ( DM ) , it remains unclear whether pioglitazone could attenuate coronary artery inflammation .


Fifty atherosclerotic patients with impaired glucose tolerance or type @ 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 @ 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 , @ pioglitazone-treated patients and @ glimepiride-treated patients ( @ men ; mean age : @ @ years ; glycosylated hemoglobin : @ @ % ) completed the study .


After @-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 ( -@ @ vs. @ @ , p = @ ) , as well as changes in high-sensitivity C-reactive protein ( pioglitazone vs. glimepiride group : median : -@ -LSB- interquartile range ( IQR ) : -@ to -@ -RSB- mg/l vs. @ -LSB- IQR : -@ to @ -RSB- mg/l , p = @ ) .


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 ; NCT@ ) .


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 < @ ) , and there was a significant difference between the two groups ( P = @ ) .


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


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 @ married men with primary premature ejaculation were randomly divided into @ groups : the sertraline group ( n = @ , sertraline @ mg/day for @ week followed by @ mg/day for @ months ) and the BT group ( n = @ , using BT technique for @ months ) .


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


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


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


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 @ 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 @th 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 @th week of the intervention ( p < @ ) .


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 @ males and @ females @ 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 < @ ) .


A logistic regression analysis showed that `` progression '' of stages was associated with improvements in the timed up and go test ( AOR @ ; @ % CI @-@ @ ) and sit and reach ( AOR @ ; @ % CI @-@ @ ) , while `` relapse '' of stages was associated with the group allocation ( AOR @ ; @ % CI @-@ @ ) , self-efficacy in `` Walking '' ( AOR @ ; @ % CI @-@ @ ) and `` Stair climbing '' ( AOR @ ; @ % CI @-@ @ ) 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 @weeks of daily intake of FDY containing @ g of FOS on glucose , lipid metabolism and intestinal transit in a group of elderly people was investigated .


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


They were randomly assigned to the supplement group ( which received @ 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 @ g of FOS for @weeks was associated with a mean decrease in serum glucose ( p = @ ) , 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 @ early active RA patients to receive : ( @ ) methotrexate , ( @ ) methotrexate/ciclosporin , ( @ ) methotrexate/prednisolone or ( @ ) methotrexate/ciclosporin/prednisolone in a factorial-design .


Patients were assessed every six months for two years .


In this analysis we evaluated @ 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 @-joint count ( DAS@ ) , Health Assessment Questionnaire ( HAQ ) , EuroQol , SF-@ 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 @ ( @ % confidence interval ( CI ) @ to @ ) with triple therapy and @ ( @ % CI @ to @ ) with monotherapy ; OR for new erosions with triple therapy versus monotherapy was @ ( @ % CI @ to @ ; P = @ ) .


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


Corticosteroid 's impact on improving DAS@/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 .


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 ) @ and @ studies .


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


A total of @ patients with NVAMD .


Patients received IAI @ mg every ( q ) @ weeks ( @q@ ) , @ mg q@ weeks ( @ q@ ) , @ mg q@ weeks ( after @ monthly doses ; @q@ ) , or ranibizumab @ mg q@ weeks ( Rq@ ) for @ weeks .


At week @ , 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 @ .


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


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


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


In an analysis integrating both studies , the proportion of study eyes with IOP > @ mmHg at week @ was @ % , @ % , @ % , and @ % in Rq@ , @q@ , @q@ , and @ q@ , respectively .


Reduction in risk , relative to Rq@ , of having sustained IOP > @ mmHg over @ weeks was @ % ( @ % confidence interval -LSB- CI -RSB- , @ % -@ % ) , @ % ( @ % CI , @ % -@ % ) , and @ % ( @ % CI , @ % -@ % ) for @q@ , @q@ , and @ q@ , respectively .


Risk reduction in the IAI groups for a sustained IOP increase @ mmHg was @ % ( @ % CI , @ % -@ % ) , @ % ( @ % CI , @ % -@ % ) , and @ % ( @ % CI , @ % -@ % ) , respectively .


In uninjected fellow eyes , only sustained IOP > @ mmHg events were higher in the Rq@ 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 @ cancer patients was randomly divided into two groups , @ patients took orally morphine sulfate sustained-release tablets in group A , and another @ patients receiving the combination treatment of intravenous flurbiprofen axetil and opioid drugs in group B.


After @ 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 @ % , as compared to @ % when morphine sulfate sustained-release tablet was used alone .


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


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


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


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 @ diabetes mellitus .


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


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 ( @ ) patient and healthcare team costs , ( @ ) metabolic control , ( @ ) knowledge of diabetes , ( @ ) quality of life , and ( @ ) self-care treatment adherence .


Of the @ patients included , @ ( @ % ) completed the study ( IG , @ ; CG , @ ) .


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


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


HbA@c improved in both groups ( IG , @ % -LSB- @ mmol/mol -RSB- vs. @ % -LSB- @ mmol/mol -RSB- -LSB- P < @ -RSB- ; CG , @ % -LSB- @ mmol/mol -RSB- vs. @ % -LSB- @ mmol/mol -RSB- -LSB- P < @ -RSB- , as did knowledge and self-care treatment adherence .


The use of interactive telematic appointments in subjects with type @ 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 @ combination oral contraceptives in @ clinical studies in which approximately @ % of enrolled participants were obese .


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


Combination oral contraceptives were LNG @ g per EE @ g ( combination oral contraceptive @ ; n = @ ) or LNG @ g per EE @ g ( combination oral contraceptive @ ; n = @ ) .


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


Treatment-emergent adverse events of @ % or greater in the LNG/EE contraceptive patch were nasopharyngitis ( @ % ) , nausea ( @ % ) , upper respiratory infection ( @ % ) , headache ( @ % ) , sinusitis ( @ % ) , cervical dysplasia ( @ % ) , and urinary tract infection ( @ % ) .


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 ( @ % ) , the combination oral contraceptive @ ( @ % ) , or the combination oral contraceptive @ ( @ % ) .


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


Serious adverse events occurred in less than @ % 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 @A-adrenoceptor subtype-selective antagonist silodosin on nocturia by analyzing three placebo-controlled registration studies .


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


Improvement/worsening rates for nocturia were calculated for once-daily silodosin @ 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 < @ times was calculated .


In total , @,@ men were treated with silodosin or placebo ; @,@ men ( @ % ) had @ voids/night at baseline .


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


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


In men with @ nocturnal voids at baseline , @ and @ % of patients with silodosin and placebo had reductions of @ voids/night , respectively ( p = @ ) , and significantly more patients with silodosin had < @ nocturia episodes at study end compared to placebo ( @ vs. @ % ; p = @ ) .


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 @A-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 @h with advice on how to improve their activity , on top of real-time visual feedback .


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


In total , @ cues were generated .


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


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


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 = @ ) who completed a study of SE in @ SCI centers .


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


A vocational rehabilitation program of SE for veterans with SCI .


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


Average cost for the SE intervention was $ @ .


In @ 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 @ 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 @ patients with recurrent depressive disorders .


All patients were randomized into two groups -- main group ( @ patients ) and comparison group ( @ 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 ( @S-@S ) and small molecular ( < @S ) 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 = @ ) .


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 @ % , and average bath duration decreased significantly ( average @ minutes less ) in the postintervention period , particularly for in-bed baths .


Verbal behaviors declined @ % ( P = @ ) , combined verbal and physical behaviors declined @ % ( P = @ ) , and antipsychotic use declined @ % ( P = @ ) 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 @ evaluable men with genital warts between June @ and October @ .


After the initial treatment intervention , @ 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 @ 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 @ men with follow-up less than @ 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 @th month .


Mean age was @ .


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 : @ CI :@ -@ P = @ ) 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 @ randomized , placebo-controlled trials of milnacipran ( n = @ ) 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 @ % 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 @ ( of @ ) .


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


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


Significantly more patients met the threshold of @ % or greater with milnacipran ( @ mg/d , @ % ; @ mg/d , @ % ) than with placebo ( @ % ) ; odds ratios for this responder status were @ and @ , respectively ( P < @ for both doses ) .


Path analyses indicated that up to @ % 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 @ completed weeks .


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


The women were allocated by a computerized telephone system to ECS scheduled at @ ( +@ ) weeks or @ ( +@ ) 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 @ women ( @ % ) completed an online questionnaire at follow-up eight weeks postpartum .


In the @ weeks group , @ ( @ % ) women @ were dissatisfied with the timing of their ECS , whereas in the @ weeks group @ ( @ % ) of @ were dissatisfied ( adjOR @ , @ % CI @ ; @ ) .


The proportion of women who preferred the same timing in a future ECS were @ ( @ % ) in the @ weeks group compared to @ ( @ % ) in the @ ( +@ ) weeks group ( adjOR @ , @ % CI @ ; @ ) .


The women in this trial preferred ECS scheduled prior to @ 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 @ 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 , @-period crossover study compared the pharmacokinetics of @ doses of RAL given at @ mg every @ hours ( that mimics a bid administration ) by swallowing with @ dose of @ mg ( that mimics a qd administration ) by chewing the tablets in @ 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 -LSB- AUC -RSB- ( @-@ ) : @ @ versus @ @ ng h/mL , P < @ ) 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 ) : @ @ versus @ @ ng/mL , P = @ ) .


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 @ 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 @-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 @ % 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 @-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 ( @ vs. @ % , p = @ ) .


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


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


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


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 @ and psoriasis-affected body surface area @ % were randomized into a TwHF ( @ mg , @ times a day ) or acitretin group ( @ mg , once a day ) .


The treatment course lasted for @ weeks .


Patients were assessed at baseline and at @ , @ , and @ weeks .


Laboratory tests were performed at baseline , week @ , and week @ .


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


A total of @ patients was enrolled ( @ TwHF ; @ acitretin ) .


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


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


There was also no significant difference in PASI @ , PASI @ , PASI @ , and PASI @ response between the two groups at @ , @ , and @ weeks .


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


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


There was no significant difference in treatment efficacy between the TwHF and acitretin groups within @ 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 , @ , and April , @ .


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


Patients were randomly allocated in a @:@ 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 @ h ambulatory systolic blood pressure at @ months .


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


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


@ ( @ % ) of @ patients screened were assigned arteriovenous coupler therapy ( n = @ ) or normal care ( n = @ ) .


Mean office systolic blood pressure reduced by @ ( SD @ ) mm Hg in the arteriovenous coupler group ( p < @ ) and by @ ( @ ) mm Hg in the control group ( p = @ ) .


Mean systolic @ h ambulatory blood pressure reduced by @ ( @ ) mm Hg ( p < @ ) in arteriovenous coupler recipients and by @ ( @ ) mm Hg ( p = @ ) in controls .


Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in @ ( @ % ) of @ 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 .


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 , @ patients with ST elevation myocardial infarction < @ h from onset were randomized to either PPCI with thrombectomy ( TB ) using an Eliminate catheter ( TB : n = @ ) or without TB ( non-TB : n = @ ) .


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


Per protocol , at follow-up @ 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 @ @ vs. @ @ % ( P = @ ) , and percentage of covered struts was @ @ vs. @ @ % ( P = @ ) 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 @-month follow-up ( Pearson 's r = @ , P = @ ) .


Up to @ 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 @-month follow-up .


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


To investigate whether there is any effect resulting from preconditioning with nutraceutical supplementation containing arginine and oil mixes with high @:@ ratio and low @:@ 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 @ ( skim milk , @ % fat ) , Group @ ( supplement with @:@ ratio of @:@ and arginine ) and Group @ ( supplement with high @:@ ratio of @:@ and low @:@ ratio of @:@ and arginine ) .


Patients received skin milk or supplements twice a day ( @ 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 @nd postoperative day ( POS ) .


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


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 @:@ ratio and low @:@ 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 @ of @ 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 @ to @ years were eligible .


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


Of @ participants , @ ( @ % ) completed the @-month follow-up .


HIV and STI risk-reduction participants had higher odds of reporting consistent condom use ( odds ratio -LSB- OR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ , @ ) and condom use at last vaginal intercourse ( OR = @ ; @ % CI = @ , @ ) 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 @ and @ 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 @ - and @-months post-baseline , while completion of transplant evaluation and receipt of LDKTs will be assessed at @-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 .


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 @ countries .


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


Trial patients consisted of @ Canadian and @,@ U.S. patients enrolled in ASCEND-HF .


Population-level cohorts consisted of @ million U.S. and @,@ Canadians hospitalized for HF in @ and@ .


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 @-day mortality ( odds ratio : @ ; @ % confidence interval : @ to @ ) 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 ( @ % ) compared with Canada ( @ % ) ( p < @ ) .


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 @ 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 ; NCT@ ) .


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-@ health questionnaire .


Secondary endpoints included comparisons across all three study groups of scores on the @ other scales of the SF-@ 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 = @ ) .


As for the primary endpoint , pain reduction was significantly greater in the intervention than in the control group ( mean difference @ points , @ % confidence interval -LSB- CI -RSB- @-@ @ points , p = @ ) .


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


On the WOMAC Index , however , statistically significant differences were found for pain reduction between the intervention and control group ( mean difference @ points , @ % CI @-@ @ , p = @ ) and between the intervention and placebo group ( mean difference @ points , @ % CI @-@ @ , p = @ ) .


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 , @-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 @ patients seeking care for chronic nonspecific low back pain .


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


Each group will receive @ sessions of @ minutes each ( @ sessions per week over @ weeks ) .


The clinical outcomes will be obtained at the completion of treatment ( @ weeks ) and at @ , @ , and @ 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 @ , @ , and @ 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 @ ( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction @ ) enrolled @,@ 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 @,@ subjects assigned to clopidogrel , @,@ ( @ % ) were on a CYP@A@-metabolized statin , and @ ( @ % ) 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 -LSB- HR -RSB- : @ , @ % confidence interval -LSB- CI -RSB- : @ to @ ) or CCBs ( adjusted HR : @ ; @ % CI : @ to @ ) in clopidogrel-treated patients .


Further , the combined use of a CCB and atorvastatin @ mg daily ( adjusted HR : @ ; @ % CI : @ to @ ) , or a CCB , statin , and proton pump inhibitor ( adjusted HR : @ ; @ % CI : @ to @ ) 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 = @ , @ , 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 ( E@ ) , 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 @ to @ ( @ ) / L were randomized to placebo or avatrombopag in two sequential cohorts .


Cohort A : placebo vs. one of @ different doses ( @mg loading dose followed by @ , @ , or @ mg/day on days @-@ ) of a first-generation avatrombopag formulation .


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


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


A total of @ patients were randomized : @ patients ( @ , cohort A ; @ , cohort B ) to avatrombopag and @ ( @ , cohort A ; @ cohort B ) to placebo .


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


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


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


One patient in the ( @/@ ) 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 @ persons ( @ women and @ men ) , aged @-@ 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 X@ test .


Statistically significant test values were those with p < @ .


The internet was a source of information about the impact of smoking cigarettes on health for @ % women and @ % men , about the alcohol effect on health for @ % women and @ % men , while about energy drinks for @ % of women and @ % 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 @ % of women and @ % of men , about alcohol consumption - @ % women and @ % 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 ( @ % ) compared to males ( @ % ) ( X@ = @ , p < @ ) .


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 : ACTRN@ ) .


The primary outcome was remission of the depressive episode ( defined as a Hamilton Rating Scale for Depression score @ at @ 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 @ months was significantly higher in the interpersonal counselling group compared with the SSRI group ( @ % v. @ % , P = @ ) .


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


Corresponding classification rules were constructed using a classification tree method .


Probabilities for transitioning from baseline to Week @ category were estimated for placebo and duloxetine patients ( Ntotal = @ ) 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 @ distinct clusters based on these @ symptom domains .


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


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


Duloxetine patients were significantly more likely to improve after @ 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 @ variables , which may guide individual patient management .


Duloxetine showed higher improvement rates than placebo and had a sustained effect beyond @ 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 @ 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 @ months .


The T-score showed improvement in the control arm ( group A ) from -@ @ to -@ @ , a gain of @ per cent ( P < @ ) and in drug arm ( group B ) -@ @ to -@ @ , registering a gain of @ per cent ( P < @ ) .


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 @ tailoring conditions ( ie , sequential , simultaneous , and control conditions ) in the Netherlands in @-@ .


Follow-up measurements took place after @ and @ months .


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


In a health risk appraisal , all respondents ( N = @ ) 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 = @ ) and simultaneous ( n = @ ) 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 @ 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 @ months ( T@ , effect size = @ ) .


After @ months ( T@ ) , the simultaneous condition was most effective ( effect size = @ ) .


All @ 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 ( T@ effect size = @ ; T@ effect size = @ ) .


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


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


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 @ years .


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


All patients were followed yearly up to @ years .


Major adverse cardiac events ( MACEs ) ( cardiac death , myocardial infarction -LSB- MI -RSB- , revascularization ) related to the target SVG lesion tended to be lower in the PES group ( @ % vs @ % ; P = @ ) due to a lower lesion revascularization rate ( @ % vs @ % ; P = @ ) , with no difference in cardiac death or MI between groups .


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


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


Over a @-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 @ patients scheduled for elective surgery for cervical spondylosis at Peking University Third Hospital between August @ and March @ .


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 @ , @ , and @ , 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 : @ , @ , @ , @ , and @ , respectively ) .


The sensitivity and specificity of the combined model were @ % and @ % , 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 ( NCT@ ) , enrolling first-time DUI arrestees at a county jail from December @ through April @ .


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


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


We enrolled @ subjects ( @ to each arm ) , and @ ( @ % , @ control and @ BI ) completed the @-day follow-up .


Mean ( SD ) age was @ ( @ ) years , and @ % were men .


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


Mean ( SD ) baseline AUDIT scores were @ ( @ ) among control subjects and @ ( @ ) among BI subjects .


At @ days , AUDIT scores decreased by a mean ( SD ) @ ( @ ) units among control subjects and @ ( @ ) among BI subjects ( difference , -@ ; @ % confidence interval -LSB- CI -RSB- , -@ to +@ ) .


The likelihood of subsequent binge drinking -LSB- relative risk ( RR ) @ ; @ % CI , @-@ @ ; BI vs. control -RSB- , abstinence ( RR , @ ; @ % CI , @-@ @ ) , alcohol-related injury to self or others ( RR , @ ; @ % CI , @-@ @ ) , and seeking treatment ( RR , @ ; @ % CI , @-@ @ ) did not differ .


A single BI counseling session shortly after first-time DUI arrest does not reduce @-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 ( @:@ ratio ) to receive pemetrexed @ mg/m ( @ ) intravenously once every @ weeks plus either oral pazopanib @ mg daily or cisplatin @ mg/m ( @ ) intravenously once every @ weeks up to six cycles .


All patients received folic acid , vitamin B@ , and steroid prophylaxis .


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


The study was terminated after @ of @ 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 , @ versus @ weeks , respectively ; hazard ratio = @ ; @ % confidence interval , @ % -@ % ; p = @ ) or objective response rate ( @ % versus @ % , respectively ; @ % confidence interval , -@ % to @ % ; p = @ ) .


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 @ female inmates randomised for this study , @ ( @ % ) refused to participate and @ ( @ % ) 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 @ ( n = @ ; @ % ) , early-onset alcohol and drug users ; and cluster @ ( n = @ ; @ % ) , late-onset alcohol and drug users .


Higher depression levels , higher incidence of committing robbery and less official history of recidivism were associated with cluster @ 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 -LSB- A-MCI -RSB- and nonamnestic MCI -LSB- NA-MCI -RSB- ) .


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


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


At baseline and every @ 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 @ participants with normal cognition at baseline , @ developed incident MCI .


The median duration of follow-up was @ years ( interquartile range , @-@ @ years ) .


A diagnosis of COPD significantly increased the risk for NA-MCI by @ % ( hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ) , 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 @ years at baseline had the greatest risk for any MCI ( hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ) and NA-MCI ( @ -LSB- @-@ @ -RSB- ) .


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 ; @-@ ) were used to prepare multivariable longitudinal regression models predicting annual smoking cessation in those who were current smokers at study entry ( n = @ , 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 < @ ) .


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 -LSB- OR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ to @ ; P < @ ) , was suspicious for lung cancer but stable from previous screens ( OR = @ ; @ % CI = @ to @ ; P < @ ) , or was suspicious for lung cancer and was new or changed from the previous screen ( OR = @ ; @ % CI = @ to @ ; P < @ ) .


Differences in smoking prevalence were present up to @ 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 @ 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 @-@ .


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


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


In the @-@ season , @ 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 ' ( @ % vs @ % ; P = @ ) .


Effects were seen in the winter ( @ % vs @ % ; P = @ ) , not fall ( @ % vs @ % ) .


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


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


During the @-@ season , it displayed for @ unique visits ; clinicians interacted with it in @ % 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 .