However , due to financial constraints , intravenous ( IV ) chemotherapy without cetuximab is commonly used in lesser developed countries .


We believe that oral metronomic chemotherapy may be safer and more effective in this setting .


We conducted an open label , superiority , parallel design , randomized phase II trial comparing oral MCT -LSB- daily celecoxib ( @mg twice daily ) and weekly methotrexate ( @mg/m ( @ ) ) -RSB- to intravenous single agent cisplatin ( IP ) ( @mg/m ( @ ) ) given @ weekly .


Eligible patients had head and neck cancers requiring palliative chemotherapy with ECOG PS @-@ and adequate organ functions who could not afford cetuximab .


The primary end point was progression-free survival .


@ Patients were recruited between July @ to May @ , @ randomized to the MCT arm and @ to the IP arm .


Patients in the MCT arm had significantly longer PFS ( median @ days , @ % CI : @-@ @ days ) compared to the IP arm ( median @ days , @ % CI ; @-@ @ days ) ( p = @ ) .


The overall survival ( OS ) was also increased significantly in the MCT arm ( median @ days , @ % CI : @-@ @ days ) compared to the IP arm ( median @ days , @ % CI : @-@ @ days ) ( p = @ ) .


There were fewer grade @/@ adverse effects with MCT , which was not significant .


( @ % vs. @ % , P = @ ) .


Oral metronomic chemotherapy has significantly better PFS and OS than single agent platinum in the palliative setting .


Incisional hernia is one of the most frequent postoperative complications after abdominal surgery .


Patients with an abdominal aortic aneurysm and patients with a body mass index of @ or higher have an increased risk to develop incisional hernia .


Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence .


This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial , a multicenter double blind randomized controlled trial .


Between @ and @ patients were included if they were operated via midline laparotomy , and had an abdominal aortic aneurysm or a body mass index of @ or higher .


Patients were randomly assigned to either receive primary suture , onlay mesh augmentation ( OMA ) , or sublay mesh augmentation .


Outcomes represent results after @-month follow-up .


A total of @ patients were randomized .


During analysis , significantly ( P = @ ) more seromas were detected after OMA ( n = @ , @ % ) compared with primary suture ( n = @ , @ % ) and sublay mesh augmentation ( n = @ , @ % ) .


No differences were discovered in any of the other outcomes such as surgical site infection , hematoma , reintervention , or readmission .


Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of @ ( P = @ ) compared with primary suture and an odds ratio of @ ( P = @ ) compared with sublay mesh augmentation .


On the basis of these short-term results , primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA , but without an increased risk of surgical site infection .


Cardiovascular ( CV ) disease is the leading cause of morbidity and mortality in patients with type @ diabetes mellitus ( T@DM ) .


Furthermore , patients with T@DM and acute coronary syndrome ( ACS ) have a particularly high risk of CV events .


The glucagon-like peptide @ receptor agonist , lixisenatide , improves glycemia , but its effects on CV events have not been thoroughly evaluated .


ELIXA ( www.clinicaltrials.gov no .


NCT@ ) is a randomized , double-blind , placebo-controlled , parallel-group , multicenter study of lixisenatide in patients with T@DM and a recent ACS event .


The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk .


The primary efficacy end point is a composite of time to CV death , nonfatal myocardial infarction , nonfatal stroke , or hospitalization for unstable angina .


Data are systematically collected for safety outcomes , including hypoglycemia , pancreatitis , and malignancy .


Enrollment began in July @ and ended in August @ ; @,@ patients from @ countries were randomized .


Of these , @ % are men and @ % are white ; at baseline , the mean SD age was @ @ years , body mass index was @ @ kg/m ( @ ) , and duration of T@DM was @ @ years .


The qualifying ACS was a myocardial infarction in @ % and unstable angina in @ % .


The study will continue until the positive adjudication of the protocol-specified number of primary CV events .


ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide @ receptor agonist in people with T@DM and high CV event risk .


The Combined Aerobic and Resistance Exercise Trial tested different types and doses of exercise in breast cancer patients receiving chemotherapy .


Here , we explore potential moderators of the exercise training responses .


Breast cancer patients initiating chemotherapy ( N = @ ) were randomly assigned to three times a week , supervised exercise of a standard dose of @-@ min of aerobic exercise , a higher dose of @-@ min of aerobic exercise , or a higher dose of @-@ min of combined aerobic and resistance exercise .


Outcomes were patient-reported symptoms and health-related fitness .


Moderators were baseline demographic , exercise/fitness , and cancer variables .


Body mass index moderated the effects of the exercise interventions on bodily pain ( P for interaction = @ ) , endocrine symptoms ( P for interaction = @ ) , taxane/neuropathy symptoms ( P for interaction = @ ) , aerobic fitness ( P for interaction = @ ) , muscular strength ( P for interaction = @ ) , and fat mass ( P for interaction = @ ) .


In general , healthy weight patients responded better to the higher-dose exercise interventions than overweight/obese patients .


Menopausal status , age , and baseline fitness moderated the effects on patient-reported symptoms .


Premenopausal , younger , and fitter patients achieved greater benefits from the higher-dose exercise interventions .


Healthy weight , fitter , and premenopausal/younger breast cancer patients receiving chemotherapy are more likely to benefit from higher-dose exercise interventions .


Implantable cardioverter-defibrillators ( ICDs ) treat ventricular tachycardia or fibrillation but may also deliver unnecessary shocks .


We sought to determine if the frequency of ICD-detected non-sustained or diverted ( NSD ) episodes increases before appropriate or inappropriate ICD shocks .


We evaluated NSD episodes in the INTRINSIC RV Trial and their relationship to ICD shocks ( appropriate and inappropriate ) .


Time from NSD to shock was analysed .


Results were validated by utilizing @ adjudicated ICD and cardiac resynchronization therapy-defibrillator shocks following NSD episodes collected through the LATITUDE remote monitoring system as part of the ALTITUDE-REDUCES Study .


In INTRINSIC RV , @ participants received @ shocks ; @ had at least @ NSD episode .


Non-sustained or diverted frequency increased @ h before the first shock for those receiving an inappropriate ( P < @ ) but not an appropriate shock ( P = @ ) .


Patients with NSD episodes within @ h of a shock were significantly more likely to receive inappropriate therapy -LSB- odds ratio ( OR ) = @ , P < @ -RSB- .


At the receiver operator curve determined optimal cutoff , an NSD episode within @ min before shock strongly predicted inappropriate therapy ( sensitivity @ % , specificity @ % ; OR = @ , and P < @ ) .


The @ min cut-off evaluated on an independent dataset of @ shock episodes preceded by an NSD in the ALTITUDE-REDUCES Study confirmed these results ( sensitivity = @ % , specificity = @ % , OR = @ , and P < @ ) .


Device-detected NSD episodes increase before inappropriate but not appropriate shocks .


Novel alerts or automated algorithms based on NSD episodes may reduce inappropriate shocks .


Nutritional interventions have shown increased energy intake but not improvement in health-related quality of life ( HRQL ) or prognosis in non small cell lung cancer ( NSCLC ) patients .


Eicosapentaenoic acid has been proposed to have anti-inflammatory , anticachectic and antitumoural effects .


To compare the effect of an oral EPA enriched supplement with an isocaloric diet on nutritional , clinical and inflammatory parameters and HRQL in advanced NSCLC patients .


Patients with advanced NSCLC were randomized to receive diet plus oral nutritional supplement containing EPA ( ONS-EPA ) or only isocaloric diet ( C ) .


All patients received paclitaxel and cisplatin/carboplatin treatment .


Weight , body composition , dietary intake , inflammatory parameters and HRQL were assessed at baseline and after the first and second cycles of chemotherapy .


Response to chemotherapy and survival were evaluated .


Ninety two patients were analysed ( @ ONS-EPA ,@ C ) .


ONS-EPA group had significantly greater energy ( p < @ ) and protein ( p < @ ) intake compared with control .


Compared with baseline , patients receiving the ONS-EPA gained @ kg of lean body mass ( LBM ) compared with a loss of-@ @ kg in the control ( p = @ ) .


Fatigue , loss of appetite and neuropathy decreased in the ONS-EPA group ( p@ @ ) .


There was no difference in response rate or overall survival between groups .


Patients with NSCLC receiving ONS-EPA significantly improves energy and protein intake , body composition .


and decreased fatigue , loss of appetite and neuropathy .


Registered with ClinicalTrials.gov ( NCT@ ) .


To examine the influence of exercise intensity on postprandial health outcomes in adolescents when exercise is accumulated throughout the day .


@ adolescents ( @ male , @ years old ) completed three @-day trials in a randomised order : ( @ ) rest ( CON ) ; or four bouts of ( @ ) @ min cycling at @ % peak power with @ s recovery ( high-intensity interval exercise ; HIIE ) ; or ( @ ) cycling at @ % of the gas exchange threshold ( moderate-intensity exercise ; MIE ) , which was work-matched to HIIE .


Each bout was separated by @ hours .


Participants consumed a high fat milkshake for breakfast and lunch .


Postprandial triacylglycerol ( TAG ) , glucose , systolic blood pressure ( SBP ) and fat oxidation were assessed throughout the day .


There was no effect of trial on total area under the curve ( TAUC ) for TAG ( P = @ ) .


TAUC-glucose was lower in HIIE compared to CON ( P = @ , ES = @ ) and MIE ( P = @ , ES = @ ) , with no difference between MIE and CON ( P = @ , ES = @ ) .


Postprandial SBP was lower in HIIE compared to CON ( P = @ , ES = @ ) and MIE ( P = @ , ES = @ ) , but not different between MIE and CON ( P = @ , ES = @ ) .


Resting fat oxidation was increased in HIIE compared to CON ( P = @ , ES = @ ) and MIE ( P = @ , ES = @ ) , with no difference between MIE and CON ( P = @ , ES = @ ) .


Neither exercise trial attenuated postprandial lipaemia .


However , accumulating brief bouts of HIIE , but not MIE , reduced postprandial plasma glucose and SBP , and increased resting fat oxidation in adolescent boys and girls .


The intensity of accumulated exercise may therefore have important implications for health outcomes in youth .


Malaria during pregnancy has serious consequences that are worsened by HIV infection .


Malaria preventive measures for HIV-infected pregnant women include cotrimoxazole ( CTX ) prophylaxis given to prevent HIV-related opportunistic infections and also protective against malaria , or intermittent preventive treatment ( IPTp ) with an antimalarial drug .


Here , we present the first study evaluating CTX efficacy versus mefloquine ( MQ ) - IPTp , alone and in combination , in HIV-infected pregnant women .


We conducted @ randomized , open-label , noninferiority trials in Benin .


In the CTX-mandatory trial , HIV-infected women with CD@ counts of < @ per cubic millimeter received CTX either alone or with MQ-IPTp ( N = @ ) .


In the CTX-not-mandatory trial ( CD@ count > @/mm ) , CTX was compared with MQ-IPTp ( N = @ ) .


In both the trials , the primary end point was microscopic placental parasitemia .


At delivery , @ woman in each CTX-alone treatment group exhibited placental parasitemia , versus no women in the groups receiving MQ .


CTX alone demonstrated noninferiority in the CTX-mandatory trial .


However , polymerase chain reaction-detected placental parasitemia was markedly reduced in the CTX + MQ group compared with CTX alone ( @/@ vs. @/@ , P = @ ) .


Because of insufficient recruitment in the CTX-not-mandatory trial , noninferiority could not be conclusively assessed .


Dizziness and vomiting of moderate intensity were reported by @ % -@ % of women receiving MQ in both the trials , versus @ % -@ % in CTX groups ( P < @ ) .


No serious adverse events related to these drugs were found .


CTX alone provided adequate protection against malaria in HIV-infected pregnant women , although MQ-IPTp showed higher efficacy against placental infection .


Although more frequently associated with dizziness and vomiting , MQ-IPTp may be an effective alternative given concerns about parasite resistance to CTX .


The best method of initial airway management during resuscitation for out of hospital cardiac arrest ( OHCA ) is unknown .


The airway management techniques used currently by UK paramedics during resuscitation for OHCA are not well documented .


This study describes the airway management techniques used in the usual practice arm of the REVIVE-Airways feasibility study , and documents the pathway of interventions to secure and sustain ventilation during OHCA .


Data were collected from OHCAs attended by paramedics participating in the REVIVE-Airways trial between March @ and February @ .


Patients were included if they were enrolled in the usual practice arm of the study , fulfilled the main study eligibility criteria and did not receive either of the intervention supraglottic airway devices during the resuscitation attempt .


Data from @ attempted resuscitations were included in the analysis .


The initial approach to airway management was bag-mask for @ ( @ % ) , a supraglottic airway device ( SAD ) for @ ( @ % ) and tracheal intubation for @ ( @ % ) .


Paramedics made further airway interventions in @ % of resuscitations .


When intubation was the initial approach , there was no further intervention in @ % of cases ; this compares to @ % and @ % with bag-mask and SAD respectively .


The most common reason cited by paramedics for changing from bag-mask was to carry out advanced life support , followed by regurgitation and inadequate ventilation .


Inadequate ventilation was the commonest reason cited for removing a SAD .


Paramedics use a range of techniques to manage the airway during OHCA , and as the resuscitation evolves .


It is therefore desirable to ensure that a range of techniques and equipment , supported by effective training , are available to paramedics who attend OHCA .


In the HORIZONS trial , in-hospital treatment with bivalirudin reduced bleeding and mortality in primary percutaneous coronary intervention ( PCI ) compared with heparin and routine glycoprotein IIb/IIIa inhibitors ( GPI ) .


It is unknown whether this advantage of bivalirudin is observed in comparison with heparins only with GPI used as bailout .


In the EUROMAX study , @ patients with ST-segment elevation myocardial infarction ( STEMI ) were randomized during transport for primary PCI to bivalirudin or to heparins with optional GPI .


Primary and principal outcome was the composites of death or non-CABG-related major bleeding at @ days .


This pre-specified analysis compared patients receiving bivalirudin ( n = @ ) with those receiving heparins with routine upstream GPI ( n = @ ) and those receiving heparins only with GPI use restricted to bailout ( n = @ ) .


The primary outcome death and major bleeding occurred in @ % with bivalirudin , @ % with heparin plus routine GPI ( HR @ and @ % CI @-@ @ , P = @ ) , and @ % with heparins plus bailout GPI ( HR @ and @ % CI @-@ @ , P = @ ) .


Following adjustment by logistic regression , bivalirudin was still associated with significantly lower rates of the primary outcome ( odds ratio @ , @ % CI @-@ @ ) and major bleeding ( odds ratio @ , @ % CI @-@ @ ) compared with heparins alone with bailout GPI .


Rates of stent thrombosis were higher with bivalirudin ( @ vs. @ vs. @ % , P = @ and @ ) .


Bivalirudin , started during transport for primary PCI , reduces major bleeding compared with both patients treated with heparin only plus bailout GPI and patients treated with heparin and routine GPI , but increased stent thrombosis .


This study aimed to investigate the impact of ticagrelor on adenosine plasma concentration ( APC ) in acute coronary syndrome ( ACS ) patients .


Ticagrelor is a direct-acting P@Y@-adenosine diphosphate receptor blocker .


The clinical benefit of ticagrelor compared with clopidogrel in ACS patients suggests that the drug has non-platelet-directed properties .


Animal andin vitro models suggested that the `` pleiotropic '' properties of ticagrelor may be related to an interaction with adenosine metabolism .


We prospectively randomized @ ACS patients to receive ticagrelor or clopidogrel .


The APC was measured by liquid chromatography .


To assess the mechanism of APC variation , we measured adenosine deaminase concentration , adenosine uptake by red blood cells , and cyclic adenosine monophosphate production by cells overexpressing adenosine receptors .


The P@Y@-adenosine diphosphate receptor blockade was assessed by the vasodilator-stimulated phosphoprotein index .


Patients receiving ticagrelor had significantly higher APC than patients receiving clopidogrel ( @ M -LSB- interquartile range : @ to @ M -RSB- vs. @ M -LSB- interquartile range : @ to @ M -RSB- ; p < @ ) .


The APC was not correlated with vasodilator-stimulated phosphoprotein ( p = @ ) .


Serum-containing ticagrelor inhibited adenosine uptake by red blood cells compared with clopidogrel or controls ( p < @ for both comparisons ) .


Adenosine deaminase activity was similar in serum of patients receiving clopidogrel or ticagrelor ( p = @ ) .


Ticagrelor and clopidogrel had no direct impact on adenosine receptors ( p = not significant ) .


Ticagrelor increases APC in ACS patients compared with clopidogrel by inhibiting adenosine uptake by red blood cells .


To test the hypothesis that neonatal supplementation with lutein in the first hours of life reduces neonatal oxidative stress ( OS ) in the immediate postpartum period .


A randomized controlled , double-blinded clinical trial was conducted among @ newborns divided into control group , not supplemented ( n = @ ) , and test group , supplemented with lutein on the first day postpartum ( n = @ ) .


Blood Samples were collected at birth from cord and at @hrs postpartum while routine neonatal metabolic screenings were taking place .


Total hydroperoxide ( TH ) , advanced oxidation protein products ( AOPP ) , and biological antioxidant potential ( BAP ) were measured by spectrophotometry and data were analyzed by Wilcoxon rank sum test and by multivariate logistic regression analysis .


Before lutein supplementation , the mean blood concentrations of AOPP , TH , and BAP were @ umol/L , @ mmol/H@O@ , and @ umol/L in the test group .


After lutein supplementation , significantly higher BAP increment ( @ versus @ versus @ ) and lower TH increment ( @ versus @ ) were observed in the test group compared to controls .


Neonatal supplementation with lutein in the first hours of life increases BAP and reduces TH in supplemented babies compared to those untreated .


The generation of free radical-induced damage at birth is reduced by lutein .


This trial is registered with ClinicalTrials.gov NCT@ .


The efficacy and toxic effects of nucleoside reverse-transcriptase inhibitors ( NRTIs ) are uncertain when these agents are used with a protease inhibitor in second-line therapy for human immunodeficiency virus ( HIV ) infection in resource-limited settings .


Removing the NRTIs or replacing them with raltegravir may provide a benefit .


In this open-label trial in sub-Saharan Africa , we randomly assigned @ adults and adolescents with HIV infection and first-line treatment failure to receive a ritonavir-boosted protease inhibitor ( lopinavir-ritonavir ) plus clinician-selected NRTIs ( NRTI group , @ patients ) , a protease inhibitor plus raltegravir in a superiority comparison ( raltegravir group , @ patients ) , or protease-inhibitor monotherapy after @ weeks of induction therapy with raltegravir in a noninferiority comparison ( monotherapy group , @ patients ) .


The primary composite end point , good HIV disease control , was defined as survival with no new World Health Organization stage @ events , a CD@ + count of more than @ cells per cubic millimeter , and a viral load of less than @,@ copies per milliliter or @,@ copies or more with no protease resistance mutations at week @ and was analyzed with the use of imputation of data ( @ % ) .


Good HIV disease control was achieved in @ % of the patients ( mean , @ patients ) in the NRTI group , @ % of the patients ( mean , @ ) in the raltegravir group ( P = @ for the comparison with the NRTI group ; superiority of raltegravir not shown ) , and @ % of the patients ( mean , @ ) in the monotherapy group ( noninferiority of monotherapy not shown , based on a @-percentage-point margin ) .


There was no significant difference in rates of grade @ or @ adverse events among the three groups ( P = @ ) .


The viral load was less than @ copies per milliliter in @ % of patients in the NRTI group , @ % in the raltegravir group ( P = @ ) , and @ % in the monotherapy group ( P < @ ) .


When given with a protease inhibitor in second-line therapy , NRTIs retained substantial virologic activity without evidence of increased toxicity , and there was no advantage to replacing them with raltegravir .


Virologic control was inferior with protease-inhibitor monotherapy .


( Funded by European and Developing Countries Clinical Trials Partnership and others ; EARNEST Current Controlled Trials number , ISRCTN@ , and ClinicalTrials.gov number , NCT@ . )


To assess the clinical efficacy on post-stroke shoulder-hand syndrome ( SHS ) treated with acupuncture and rehabilitation and the impacts on patients ' nailfold microcirculation .


One hundred and twenty patients were randomized into an acupuncture rehabilitation group and a simple rehabilitation group , @ cases in each one .


In the simple rehabilitation group , OT ( comprehensive rehabilitation therapy ) training was adopted .


In the acupuncture rehabilitation group , on the basis of the treatment as the simple rehabilitation , acu puncture was added at Taiyuan ( LU @ ) , Zusanli ( ST @ ) , Xuanzhong ( GB @ ) , Waiguan ( TE @ ) , Shousanli ( LI @ ) , Quchi ( LI @ ) and Jianyu ( LI @ ) .


Acupuncture was given once a day , @ days made one session .


Totally , @ sessions of treatment were required .


Fugl-Meyer score , upper limb pain score , the score of nerve function defect and the items of nailfold microcirculation of patients were assessed in the the two groups before and after treatment .


The efficacy was compared between the two groups .


( @ ) The upper limb pain , the systematic motor function of the upper limbs , the nerve function defect , nailfold microcirculation and clinical symptoms were all improved after treatment in either the acupuncture rehabilitation group or the simple rehabilitation group as compared with those before treatment , indicating the significant difference ( P < @ , P < @ ) .


( @ ) The im provements in the upper limb pain ( @ + / -@ vs @ + / -@ ) , the systematic motor function of the upper limbs ( @ @ vs @ + / -@ ) , the nerve function defect ( @ + / -@ vs @ + / -@ ) , nailfold microcirculation ( total score @ + / -@ vs @ + / -@ ) and clinical symptoms in the acupuncture rehabilitation group after treatment were different significantly as compared with those in the simple rehabilitation group ( PO@,P-O .


@ ) , and the results in the acupuncture rehabilitation group were superior to the simple rehabilitation group .


( @ ) In the acupuncture rehabilitation group , the markedly effective rate was @ % ( @/@ ) and the total effective rate was @ % ( @/@ ) , which was better than @ % ( @/@ ) and @ % ( @/@ ) respectively in the simple rehabilitation group ( all P < @ ) .


Both the combined therapy of acupuncture and rehabilitation and the simple rehabilitation training are effective in the treatment of post-stroke SHS , and promote the status of nailfold microcirculation , the efficacy of the combined therapy is better than that of the latter .


Preterm infants have immature respiratory control and resulting intermittent hypoxia ( IH ) .


The extent of IH after stopping routine caffeine treatment and the potential for reducing IH with extended caffeine treatment are unknown .


To determine ( @ ) the frequency of IH in premature infants after discontinuation of routine caffeine treatment and ( @ ) whether extending caffeine treatment to @ weeks ' postmenstrual age ( PMA ) reduces IH .


A prospective randomized clinical study was conducted at @ neonatal intensive care units in the United States , with an @-month enrollment period .


Preterm infants ( < @ weeks ' gestation ) previously treated with caffeine were randomized to extended caffeine treatment or usual care ( controls ) at a PMA of at least @ weeks but less than @ weeks .


Continuous pulse oximeter recordings were obtained through @ weeks ' PMA .


Oximeter data were analyzed by persons masked to patient group .


Continued treatment with caffeine .


Number of IH events and seconds with less than @ % hemoglobin oxygen saturation ( Sao@ ) per hour of recording .


Our analysis included @ preterm infants .


In control infants , the mean ( SD ) time at less than @ % Sao@ at @ and @ weeks ' PMA was @ ( @ ) and @ ( @ ) s/h , respectively .


The number of IH events decreased significantly from @ to @ weeks ' PMA ( P = @ ) .


Extended caffeine treatment reduced the mean time at less than @ % Sao@ by @ % ( @ % CI , -@ % to -@ % ) to @ ( @ ) s/h at @ weeks and by @ % ( @ % CI , -@ % to -@ % ) to @ ( @ ) s/h at @ weeks .


Substantial IH persists after discontinuation of routine caffeine treatment and progressively decreases with increasing PMA .


Extended caffeine treatment decreases IH in premature infants .


To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone .


Single-blinded randomized controlled clinical trial in a regional teaching hospital .


The patients received either topical @ % atropine nightly plus auricular acupoint stimulation ( @ A + ACU group ) or topical @ % atropine alone nightly ( @ A group ) .


The changes in spherical equivalent ( SE ) , axial length ( AL ) , anterior chamber depth ( ACD ) , and intraocular pressure ( IOP ) per year were compared between the two groups .


Seventy-three of @ total patients ( @ % ) completed at least @ months of follow-up .


Patients in the @ A + ACU group had less myopic progression and AL elongation ( -@ diopter and @ mm/year ) than those in the @ A group ( -@ diopter and @ mm/year ) ( mean follow-up @ months , p < @ and p = @ , respectively ) .


The ACD increased more in the @ A + ACU group than in the @ A group ( @ mm vs. @ mm/year , p = @ ) .


IOP decreased more in the @ A + ACU group than in the @ A group ( -@ mmHg vs. -@ mmHg/year , p = @ ) .


A decrease of @ mmHg of IOP correlated with a decrease of myopic progression of @ diopter/year ( p = @ ) .


Patients treated with @ % atropine eye drops plus auricular acupoint stimulation had less myopic progression , less axial length elongation , more anterior chamber deepening , and greater IOP reductions than those treated with @ % atropine alone .


Auricular acupoint stimulation in combination with low-concentration topical atropine was beneficial for myopia control .


To investigate the curative effect of modified Xuefuzhuyutang on chronic subdural hematoma ( CSDH ) after burr holes irrigation and drainage .


From January @ to April @,@ CSDH patients were randomly divided into two groups : @ cases of control group and @ cases of medicine group ( modified Xuefuzhuyutang ) .


Compared with the control group , the cases of total absorption of hematoma in medicine group increased significantly ( P < @ ) .


The cases of @ % -@ % , @ % -@ % and @ % -@ % absorption in above two groups had no significant differences ( P > @ ) .


There were no significant side effects were observed in the two groups .


Compared with the control group , the marked effective cases and total effective cases in medicine group were higher ( P < @ ) .


Modified Xuefuzhuyutang is effective in reducing the postoperative residual volume and recurrent CS-DH .


Congestion is the most frequent cause for hospitalization in acute decompensated heart failure .


Although decongestion is a major goal of acute therapy , it is unclear how the clinical components of congestion ( eg , peripheral edema , orthopnea ) contribute to outcomes after discharge or how well decongestion is maintained .


A post hoc analysis was performed of @ patients enrolled in the Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure ( DOSE-AHF ) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure ( CARRESS-HF ) trials during hospitalization with acute decompensated heart failure and clinical congestion .


A simple orthodema congestion score was generated based on symptoms of orthopnea ( @ pillows = @ points , < @ pillows = @ points ) and peripheral edema ( trace = @ points , moderate = @ point , severe = @ points ) at baseline , discharge , and @-day follow-up .


Orthodema scores were classified as absent ( score of @ ) , low-grade ( score of @-@ ) , and high-grade ( score of @-@ ) , and the association with death , rehospitalization , or unscheduled medical visits through @ days was assessed .


At baseline , @ % of patients had high-grade orthodema and @ % had low-grade orthodema .


At discharge , @ % patients were free from orthodema at discharge ( score = @ ) and these patients had lower @-day rates of death , rehospitalization , or unscheduled visits ( @ % ) compared with those with low-grade or high-grade orthodema ( @ % and @ % , respectively ; P = @ ) .


Of the patients without orthodema at discharge , @ % relapsed to low-grade orthodema and @ % to high-grade orthodema at @-day follow-up .


Increased severity of congestion by a simple orthodema assessment is associated with increased morbidity and mortality .


Despite intent to relieve congestion , current therapy often fails to relieve orthodema during hospitalization or to prevent recurrence after discharge .


Poor adherence contributes to uncontrolled asthma .


Pragmatic adherence interventions for primary care settings are lacking .


To test the effectiveness of @ brief general practitioner ( GP ) - delivered interventions for improving adherence and asthma control .


In a @-month cluster randomized @ @ factorial controlled trial , with GP as unit of cluster , we compared inhaler reminders and feedback ( IRF ) and/or personalized adherence discussions ( PADs ) with active usual care alone ; all GPs received action plan and inhaler technique training .


GPs enrolled patients prescribed combination controller inhalers , with suboptimal Asthma Control Test ( ACT ) scores ( ACT score @ ) .


Inhaler monitors recorded fluticasone propionate/salmeterol adherence ( covertly for non-IRF groups ) and , in IRF groups , provided twice-daily reminders for missed doses , and adherence feedback .


PAD GPs received communication training regarding adherence .


Outcomes collected every @ months included ACT scores ( primary outcome ) and severe exacerbations .


Intention-to-treat mixed-model analysis incorporated cluster effect and repeated measures .


A total of @ GPs enrolled @ patients with moderate-severe asthma ( mean age , @ @ years ; ACT score , @ @ ; fluticasone propionate dose , @ @ g ) .


Over @ months , adherence was significantly higher in the IRF group than in non-IRF groups ( @ % @ % vs @ % @ % of prescribed daily doses ; P < @ ) , but not between PAD and non-PAD groups .


Asthma control improved overall ( mean change in ACT score , @ @ ; P < @ ) , with no significant difference among groups ( P = @ ) .


Severe exacerbations were experienced by @ % of the patients in IRF groups and @ % of the patients in non-IRF groups ( P = @ ; after adjustment for exacerbation history ; P = @ ) .


Inhaler reminders offer an effective strategy for improving adherence in primary care compared with a behavioral intervention or usual care , although this may not be reflected in differences in day-to-day asthma control .


Topical formulations of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption .


We conducted randomized , crossover studies that compared the pharmacokinetics ( PK ) , bioequivalence and safety of topical diclofenac sodium @ % twice daily ( BID ) , diclofenac sodium @ % four times daily ( QID ) and oral diclofenac sodium in healthy subjects .


The results of three bioequivalence studies are reviewed .


Healthy adult subjects ( n = @ ) applied topical diclofenac sodium @ % solution ( @ mg/@ mL ) BID ; or @ % solution ( @ mg/@ drops ) QID to each knee for @ consecutive days separated by a washout period .


Subjects ( n = @ ) in one study also received oral diclofenac sodium @ mg BID for @ days .


Plasma diclofenac concentrations were determined from serial blood samples collected on Days @ and @ ( steady state ) , and diclofenac PK parameters were estimated by noncompartmental methods .


The studies demonstrated comparable bioequivalence between the @ % and @ % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately @ % less ) .


Daily systemic exposure was comparable between the two formulations with only a @ % difference in the AUCss ( @-@ ) ( p = @ ) .


Furthermore , both topical solutions demonstrated delayed elimination with a t ( @/@ ) of @ - to @-fold longer , as compared to oral diclofenac .


The @ % solution provided more consistent dosing relative to the @ % solution when comparing AUCss ( @-@ ) and Cmaxss across studies .


Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac .


The steady-state PK profile of topical diclofenac @ % solution administered BID is similar to that of the @ % solution administered QID .


Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration .


( Study @ was registered with ClinicalTrials.gov ; NCT@ ; https://clinicaltrials.gov/ct@/results?term=@&Search=Search ) .


Tracheal intubation without muscle relaxants is usually performed with remifentanil and propofol or sevoflurane .


Remifentanil @ to @ gkg ( -@ ) and propofol @-@ @ mgkg ( -@ ) or sevoflurane up to @ Vol % provide acceptable , i.e. excellent or good intubating conditions .


We hypothesized that sevoflurane @ MAC would provide acceptable intubating conditions when combined with propofol and remifentanil .


Eighty-three patients to be intubated were randomised to two groups .


The SEVO group received propofol @ mgkg ( -@ ) , remifentanil @ gkgmin ( -@ ) and sevoflurane @ MAC ; the MR group received the same doses of propofol and remifentanil plus rocuronium @ mgkg ( -@ ) .


We evaluated intubation and extubation conditions , mean arterial pressure ( MAP ) , heart rate ( HR ) and bispectral index ( BIS ) .


The vocal cords were examined for injury by videolaryngoscopy before and @hours after surgery .


ACCEPTABLE INTUBATING CONDITIONS WERE SEEN MORE FREQUENTLY WITH ROCURONIUM THAN WITH SEVOFLURANE : @ % versus @ % ; p = @ ; the subscore for vocal cords was comparable : @ % versus @ % .


MAP before intubation decreased significantly compared with the MAP at baseline to the same extent in both groups ; ephedrine IV was given in @ ( SEVO ) versus @ ( MR ) patients ; p = @ .


BIS at tracheal intubation was @ ( @-@ ) in the SEVO group , @ ( @-@ ) in the MR group ; p = @ .


Vocal cord injuries ( oedema , haematoma ) were similar : @ patients in each group .


Overall intubating conditions were better when rocuronium was used ; the subscore for vocal cords was comparable .


The incidence of side effects was the same in the two groups .


To examine parental reports of feeding and activity behaviors in a cohort of parents of @-month-olds and how they differ by race/ethnicity .


Parents participating in Greenlight , a cluster , randomized trial of obesity prevention at @ health centers , were queried at enrollment about feeding and activity behaviors thought to increase obesity risk .


Unadjusted associations between race/ethnicity and the outcomes of interest were performed by using Pearson ( @ ) and Kruskal-Wallis tests .


Adjusted analyses were performed by using proportional odds logistic regressions .


Eight hundred sixty-three parents ( @ % Hispanic , @ % black , @ % white ; @ % Medicaid ) were enrolled .


Exclusive formula feeding was more than twice as common ( @ % ) as exclusive breastfeeding ( @ % ) ; @ % had already introduced solid food ; @ % put infants to bed with bottles ; @ % propped bottles ; @ % always fed when the infant cried ; @ % always tried to get children to finish milk ; @ % were exposed to television ( mean , @ minutes/day ) ; @ % reported active television watching ( mean , @ minutes/day ) ; and @ % did not meet `` tummy time '' recommendations .


Compared with white parents , black parents were more likely to put children to bed with a bottle ( adjusted odds ratio -LSB- aOR -RSB- = @ , P < @ ; bottle propping , aOR = @ , P < @ ) , and report more television watching ( aOR = @ , P = @ ) .


Hispanic parents were more likely than white parents to encourage children to finish feeding ( aOR = @ , P = @ ) , bottle propping ( aOR = @ , P = @ ) , and report less tummy time ( aOR = @ , P = @ ) .


Behaviors thought to relate to later obesity were highly prevalent in this large , diverse sample and varied by race/ethnicity , suggesting the importance of early and culturally-adapted interventions .


Chronic liver disease and cirrhosis are collectively ranked as the ninth most prevalent cause of death in Taiwan .


Ascites is the most common comorbidity associated with liver cirrhosis .


Different body postures affect pulmonary ventilation and arterial oxygen partial pressure .


Thus , ensuring proper body posture in patients is an important clinical nursing intervention that significantly affects the recovery of patients .


This study investigates the effects of head posture on oxygenation saturation , comfort , and dyspnea in patients with liver cirrhosis-related ascites .


A quasi-experimental study design was used .


A total of @ participants were recruited from a medical centre hospital in Taiwan .


Participants were allocated randomly into three groups of bed-elevation angles : @ degrees , @ degrees , and @ degrees .


The physiological indices were measured at @ , @ , @ , @ , @ , and @ minutes in order to investigate the change in oxygenation saturations that were attributable to the different angles .


Data were analyzed using descriptive statistics .


The generalized estimating equation ( GEE ) was used for statistical analysis , with the level of significance set at : = @ .


After controlling for confounding variables , the results showed that patients in the three groups earned similar scores for the degree of difficulty in the oxygen values .


The supine group earned significantly different scores than the other two groups in terms of blood oxygen values related to time to change the angle of the three groups at five minutes after adjusting the angle ( p < @ ) .


This study found no differences among the three groups in terms of comfort .


In terms of breathing , this study found a significant difference between @-degree and @-degree supine dyspnea ( p < @ ) .


Therefore , patients with ascites at @ degrees supine and with better access to better oxygen saturation had superior results to their peers at @ degrees and @ degrees supine .


Furthermore , this group was less likely to perceive breathing difficulties .


The results of this study may guide health education and care for nurses in order to improve the quality of care for patients with chronic liver disease / cirrhosis with concomitant ascites .


Filibuvir is a non-nucleoside inhibitor of hepatitis C virus ( HCV ) polymerase .


This study evaluated the safety and efficacy of filibuvir plus pegylated interferon alfa-@a ( pegIFN ) / ribavirin .


Treatment-nave , HCV genotype-@ patients were randomized to receive filibuvir @ or @ mg twice daily ( BID ) or placebo plus pegIFN ( @ g/wk ) and ribavirin ( @,@ / @,@ mg BID ) for @ weeks .


Filibuvir patients who achieved defined response through week @ discontinued therapy at week @ .


All other patients continued on open-label pegIFN/ribavirin through week @ .


The primary endpoint was the proportion of patients who achieved sustained virologic response ( SVR ) defined as HCV RNA < @ IU/mL at end of treatment ( weeks @ or @ ) and week @ .


Overall , @ patients were randomized and treated .


SVR was achieved by @ , @ , and @ % of patients in the filibuvir @ mg , @ mg , and placebo arms , respectively .


While the addition of filibuvir to pegIFN/ribavirin improved on-treatment virologic response parameters , this did not translate into improved SVR rates due to a high rate of virologic relapse following completion of therapy ( @ mg : @ % ; @ mg : @ % ; placebo : @ % ) .


The most commonly reported adverse events were nausea , fatigue , headache , and insomnia , and were reported at similar rates across arms .


Filibuvir plus pegIFN/ribavirin did not improve the percentage of patients achieving SVR compared with administration of pegIFN/ribavirin alone .


However , the agent was well tolerated and was associated with higher on-treatment virologic response parameters .


Further evaluation of filibuvir in combination with other direct-acting antiviral agents may be considered .


The purpose of this study was to evaluate the efficacy and safety of the selective endothelin type A ( ETA ) receptor antagonist sitaxsentan in patients who have heart failure with preserved ejection fraction ( HFpEF ) .


Fifty percent of heart failure ( HF ) patients have a preserved ejection fraction .


No treatment has been shown to improve their clinical outcomes .


Previous studies have suggested that ETA receptor antagonists might improve diastolic function and exercise tolerance in some forms of HF .


In all , @ HFpEF patients ( EF@ % ) were randomly assigned @:@ to sitaxsentan @ mg/day ( n = @ ) versus placebo ( n = @ ) for @ weeks .


The primary endpoint was change in treadmill exercise time after @ weeks of treatment .


Secondary objectives included changes in left ventricular mass , transmitral inflow velocity to early diastolic mitral annulus velocity ratio , and Minnesota Living With Heart Failure questionnaire , and New York Heart Association functional class .


Subjects were age @ @ years , @ % female , @ % non-Caucasian , and in functional class II ( @ % ) or III ( @ % ) .


Subjects treated with sitaxsentan had an increase in median treadmill time ( @ s ) compared with placebo-treated subjects ( @ s , p = @ ) .


There was no significant treatment differences in transmitral inflow velocity to early diastolic mitral annulus velocity ratio , left ventricular mass , Minnesota Living With Heart Failure questionnaire , NewYork Heart Association functional class , deaths , or HF hospital stay .


The incidence of adverse events was similar for sitaxsentan and placebo .


In HFpEF patients , treatment with a selective ETA receptor antagonist increased exercise tolerance but did not improve any of the secondary endpoints such as left ventricular mass or diastolic function .


Further studies will benecessary to determine whether ETA receptor antagonists may be useful in the treatment of HFpEF .


( A Study ofthe Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure ; NCT@ ) .


Large preloads of protein and fat have been shown to lower glucose after a carbohydrate-rich meal in people with type @ diabetes but add a considerable energy burden .


Low calorie preloads -LSB- < @ % of daily energy intake -RSB- have been tested in this study in people with prediabetes and with type @ diabetes .


This was an unblinded randomised crossover study with two placebo days and two active treatment days .


Glucose was measured for @hours with fingerprick samples as well as continuous glucose monitoring -LSB- CGMS -RSB- .


Twenty-four subjects with pre-diabetes or moderately controlled type @ diabetes -LSB- fasting glucose < @ and HbA@c < @ % -RSB- were recruited .


The preload contained @g whey protein plus @g lactose and @g guar , and @g flavour material -LSB- including sucralose -RSB- dissolved in @ml cold water or @ml cold water with no additives .


The breakfast test meal consisted of @ slices of bread , margarine and jam -LSB- @ slices for men -RSB- with the test drink @minutes beforehand .


Peak fingerprick glucose was reduced by @ mmol/L at @min -LSB- p < @ -RSB- .


Average fingerprick glucose over @hours was reduced by @ mmol/L -LSB- p = @ -RSB- .


There was no difference between those with diabetes or prediabetes or those on medication or not on medication .


An @kcal whey protein/fibre preload can lower average glucose over @hours by @ mmol/L .


If used long term before at least two carbohydrate-rich meals/day this preload could lower HbA@c by up to @ % .


To evaluate the outcomes of transcrestal sinus floor elevation ( tSFE ) performed with a minimally invasive procedure ( Smart Lift technique ) combined with the additional use of deproteinized bovine bone mineral ( DBBM ) or - tricalcium phosphate ( - TCP ) .


In a multicenter randomized controlled trial , @ sites in @ patients were treated with the Smart Lift technique in association with DBBM ( n = @ ) or - TCP ( n = @ ) .


The extent of the sinus lift ( SL ) and the height of the graft apical to the implant apex ( aGH ) were assessed on periapical radiographs taken immediately after surgery and at @ months following surgery .


( i ) Substantial aGH and SL were observed immediately after surgery and at @ months , with no significant differences between DBBM and - TCP groups ; ( ii ) a significant graft remodelling was observed from post-surgery to @-months in the - TCP group and ( iii ) limited incidence of complications as well as limited post-operative pain and discomfort were associated with the use of both graft materials .


The Smart Lift technique in conjunction with the additional use of either DBBM or - TCP may provide a substantial elevation of the maxillary sinus floor along with limited post-surgical complications and post-operative pain/discomfort .


This study sought to evaluate the efficacy of prasugrel versus clopidogrel in ST-segment elevation myocardial infarction ( STEMI ) by the timing of percutaneous coronary intervention ( PCI ) .


Treatment strategies and outcomes for patients with STEMI may differ when treated with primary compared with secondary PCI .


STEMI patients in the TRITON-TIMI @ ( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction @ ) were randomized to prasugrel or clopidogrel on presentation if primary PCI was intended or later during secondary PCI .


Primary PCI was defined as within @ h of symptom onset .


The primary endpoint was cardiovascular death , myocardial infarction ( MI ) , or stroke .


Because periprocedural MI is difficult to assess in the setting of STEMI , we performed analyses excluding these events .


Reductions in the primary endpoint with prasugrel versus clopidogrel ( hazard ratio -LSB- HR -RSB- : @ ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) were consistent between primary and secondary PCI patients at @ months ( HR : @ ; @ % CI : @ to @ vs. HR : @ ; @ % CI : @ to @ ; p interaction = @ ) .


However , a tendency toward a difference in treatment effect at @ days ( HR : @ ; @ % CI : @ to @ ; p = @ ) was observed between primary and secondary PCI patients ( HR : @ ; @ % CI : @ to @ vs. HR : @ ; @ % CI : @ to @ ; p interaction = @ ) .


When periprocedural MI was excluded , the efficacy of prasugrel remained consistent among primary and secondary PCI patients at @ days ( HR : @ ; @ % CI : @ to @ vs. HR : @ ; @ % CI : @ to @ ; p interaction = @ ) and @ months ( HR : @ ; @ % CI : @ to @ vs. HR : @ ; @ % CI : @ to @ ; p interaction = @ ) .


The efficacy of prasugrel versus clopidogrel was consistent irrespective of the timing of PCI , particularly in preventing nonprocedural events .


( Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction @ ; NCT@ ) .


Validated questionnaires can improve the identification of psychosocial problems in community pediatric services .


Our aim was to assess which of @ short questionnaires-the Brief Infant-Toddler Social and Emotional Assessment ( BITSEA ) , the Ages and Stages Questionnaires : Social-Emotional ( ASQ : SE ) , and the KIPPPI ( Brief Instrument Psychological and Pedagogical Problem Inventory ) - was most suitable as a routine screening tool for identification among toddlers .


We included @ parents ( response rate @ % ) of children aged @ , @ , or @ months at routine well-child visits in @ services across the Netherlands .


Child health care professionals interviewed and examined children and parents .


Parents were randomized to complete either the BITSEA or the KIPPPI ; all filled out the ASQ : SE and the Child Behavior Checklist .


For each questionnaire , we assessed the internal consistency , validity with Child Behavior Checklist-Total Problems Score ( CBCL-TPS ) as a criterion , and added value to identification compared to clinical assessment alone .


Cronbach 's alphas of the total scales varied between @ to @ .


At the ages of @ and @ months , none of the instruments studied had adequate validity .


At the age of @ months , only the BITSEA discriminated sufficiently between children with and without problems ( sensitivity = @ at specificity = @ ) , but not the other @ questionnaires ( with sensitivity indices varying between @ and @ at similar specificity ) .


The BITSEA at this age offered slightly higher added value to the identification of psychosocial problems by child health care professionals .


For toddlers aged @ and @ months , no questionnaire is sufficiently valid to support the identification of psychosocial problems .


The BITSEA is the best short tool for the early detection of psychosocial problems in @-year-old children .


The cholesterol-lowering effects of garlic as part of a healthy diet remain controversial .


The aim of this study was to investigate whether supplementation with aged black garlic ( ABG ) could improve blood lipid profiles in patients with mild hypercholesterolemia .


We conducted a double-blind , randomized placebo-controlled trial .


Sixty participants were randomly assigned to receive either ABG or placebo twice daily ( total @ g/d ) before consumption of a meal every morning and evening for @ wk .


During the study , two participants dropped out of the ABG group , and three participants dropped out of the placebo group .


Thus , the effects of AGB on fasting blood levels of lipids were evaluated in @ participants and compared with the placebo group ( n = @ ) .


Among lipid components , no significant differences in triglycerides , low-density lipoprotein cholesterol , total cholesterol , or free fatty acid levels were observed between the two groups .


However , ABG increased high-density lipoprotein cholesterol levels compared with the placebo group at the end of the study .


Moreover , a significant decrease in the levels of alipoprotein B and a significant increase in the ratio of low-density lipoprotein cholesterol/alipoprotein B were observed in the ABG group .


No adverse effects were reported in any of the patients .


ABG supplementation reduced atherogenic markers and thus may have a cardioprotective effect beyond the gold standard medication in patients with mild hypercholesterolemia .


We evaluated the effects of colestilan , a non-absorbed anion-exchange resin , on lipids and lipoproteins in dialysis patients .


This randomized , double-blind , double-dummy , flexible-dose study incorporating a placebo-controlled withdrawal period tested for superiority vs. placebo and non-inferiority vs. simvastatin .


Dialysis patients with serum low-density lipoprotein ( LDL-C ) @ mg/dL received colestilan @ - @ g/day or simvastatin @ - @ mg/day for @ weeks , and were then re-randomized to continue active medication or receive placebo for @ weeks .


Co-primary endpoints were the percent change in serum LDL-C level during the active and placebo comparison phases .


Colestilan was non-inferior to simvastatin for lowering serum LDL-C ( mean changes -@ % vs. -@ % ; difference @ % , @ % CI -@ , @ ) .


Colestilan was more effective than placebo at maintaining control of serum LDL-C levels during the withdrawal phase ( mean change +@ % vs. +@ % ; difference -@ % ; p < @ ) .


Reductions in total cholesterol were similar with both drugs , but simvastatin was more effective at controlling triglyceride levels .


Adverse events most commonly affected the gastrointestinal system .


In dialysis patients , colestilan was more effective than placebo at maintaining control of serum LDL-C levels , was noninferior to simvastatin in terms of the reduction in LDL-C achieved , and was generally well tolerated .


Popular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health , the causal nature of which remains to be explored under real-life conditions .


The aim was to conduct a randomized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans .


The Bath Breakfast Project is a randomized controlled trial with repeated-measures at baseline and follow-up in a cohort in southwest England aged @-@ y with dual-energy X-ray absorptiometry-derived fat mass indexes @ kg/m in women ( n = @ ) and @ kg/m in men ( n = @ ) .


Components of energy balance ( resting metabolic rate , physical activity thermogenesis , energy intake ) and @-h glycemic responses were measured under free-living conditions with random allocation to daily breakfast ( @ kcal before @ ) or extended fasting ( @ kcal until @ ) for @ wk , with baseline and follow-up measures of health markers ( eg , hematology/biopsies ) .


Contrary to popular belief , there was no metabolic adaptation to breakfast ( eg , resting metabolic rate stable within @ kcal/d ) , with limited subsequent suppression of appetite ( energy intake remained @ kcal/d greater than after fasting ; @ % CI : @ , @ kcal/d ) .


Rather , physical activity thermogenesis was markedly higher with breakfast than with fasting ( @ kcal/d ; @ % CI : @ , @ kcal/d ) .


Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health .


Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention ( CV : @ % ; @ % CI : @ % , @ % ) .


Daily breakfast is causally linked to higher physical activity thermogenesis in lean adults , with greater overall dietary energy intake but no change in resting metabolism .


Cardiovascular health indexes were unaffected by either of the treatments , but breakfast maintained more stable afternoon and evening glycemia than did fasting .


Depression is common in people with coronary heart disease ( CHD ) and associated with worse outcome .


This study explored the acceptability and feasibility of procedures for a trial and for an intervention , including its potential costs , to inform a definitive randomized controlled trial ( RCT ) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression .


Multi-centre , outcome assessor-blinded , randomized parallel group study .


CHD patients reporting chest pain and scoring @ or more on the HADS were randomized to personalized care ( PC ) or treatment as usual ( TAU ) for @ months and followed for @ year .


Primary outcome was acceptability and feasibility of procedures ; secondary outcomes included mood , chest pain , functional status , well being and psychological process variables .


@ people from @ General Practice CHD registers in South London consented to be contacted ; out of @ who were potentially eligible , @ ( @ % female , mean age = @ SD@ years ) were randomized .


PC participants ( n = @ ) identified wide ranging problems to work on with nurse-case managers .


Good acceptability and feasibility was indicated by low attrition ( @ % ) , high engagement and minimal nurse time used ( mean/SD = @/@ mins assessment , @/@ mins telephone follow up ) .


Both groups improved on all outcomes .


The largest between group difference was in the proportion no longer reporting chest pain ( PC @ % vs TAU @ % ; mixed effects model OR @ @ % CI @ , @ ) .


Some evidence was seen that self efficacy ( mean scale increase of @ vs @ ) and illness perceptions ( mean scale increase of @ vs @ ) had improved in PC vs TAU participants at @ year .


PC appeared to be more cost effective up to a QALY threshold of approximately @,@ .


Trial and intervention procedures appeared to be feasible and acceptable .


PC allowed patients to work on unaddressed problems and appears cheaper than TAU .


To investigate the postoperative application of nasopharyngeal airway ( NPA ) in rhinogenous obstructive sleep apnea hypopnea syndrome ( OSAHS ) patients , so that to observe the parameters including vital signs of the patients and evaluatethe value of clinical application and reliability of NPA .


A total of @ patients diagnosed as rhinogenous OSAHS were randomly assigned to experimental group ( setting NPA , @ cases ) and control group ( not setting NPA , @ cases ) according to whether NPA was placed in the nasal cavity postoperatively .


ECG , oxygen saturation and hemodynamics were monitored for @ h postoperatively .


The pharyngeal pain and discomfort , low oxygen saturation and hemodynamics were compared between these two groups .


The subjective assessment and clinical symptoms were compared between the two groups using visual analogue scale ( VAS ) .


The experimental group showed better relief of nasal obstruction , nasal pain , headache , dry pharynx , insomnia and pain while taking out nasal packing compared with control group , where the differences were statistically significant ( P < @ ) .


In the experimental group , the level of LSa@O@ ( P < @ ) , HR ( P < @ ) , SBP ( P < @ ) , DBP ( P < @ ) , MAP ( P < @ ) and RPP ( P < @ ) was significantly lower than in the control group .


The postoperative application of nasopharyngeal airway in rhinogenous OSAHS patients could help to keep nasal patency and avoid the upper airway obstruction , which exhibited good safety and compliance .


The nasopharyngeal airway can reduce patients ' discomfort and improve hyoxemia , ensuring hemodynamic stability .


Activation of the phosphatidylinositol-@-kinase ( PI@K ) and/or mitogen-activated protein kinase ( MAPK ) pathways results in anti-estrogen resistance in vitro , but a biomarker with clinical validity to predict intrinsic resistance has not been identified .


In metastatic breast cancer patients with previous exposure to endocrine therapy , the addition of a mammalian target of rapamycine ( mTOR ) inhibitor has been shown to be beneficial .


Whether or not patients on adjuvant endocrine treatment might benefit from these drugs is currently unclear .


A biomarker that predicts intrinsic resistance could potentially be used as companion diagnostic in this setting .


We tested the clinical validity of different downstream-activated proteins in the PI@K and/or MAPK pathways to predict intrinsic tamoxifen resistance in postmenopausal primary breast cancer patients .


We recollected primary tumor tissue from patients who participated in a randomized trial of adjuvant tamoxifen ( @-@ years ) versus observation .


After constructing a tissue micro-array , cores from @ estrogen receptor positive were immunostained for p-AKT ( Thr@ ) , p-AKT ( Ser@ ) , p-mTOR , p-p@SK and p-ERK@ / @ .


Cox proportional hazard models for recurrence free interval were used to assess hazard ratios and interactions between these markers and tamoxifen treatment efficacy .


Interactions were identified between tamoxifen and p-AKT ( Thr@ ) , p-mTOR , p-p@S@K and p-ERK@ / @ .


Applying a conservative level of significance , p-p@S@K remained significantly associated with tamoxifen resistance .


Patients with p-p@S@K negative tumors derived significant benefit from tamoxifen ( HR @ , P < @ ) , while patients whose tumor did express p-p@S@K did not ( HR = @ , P = @ ) , P for interaction @ .


In systemically untreated breast cancer patients , p-p@S@K was associated with a decreased risk for recurrence .


Patients whose tumor expresses p-p@S@K , as a marker of downstream PI@K and/or MAPK pathway activation , have a favorable prognosis , but do not benefit from adjuvant tamoxifen .


A potential benefit from inhibitors of the PI@K/Akt/mTOR pathway in these patients needs to be further explored .


The objective of this article is to present the rationale and baseline results for a randomized controlled pilot trial using economic incentives to reduce HIV and sexually transmitted infection ( STI ) risk among male sex workers ( MSWs ) in Mexico City .


Participants ( n = @ ) were tested and treated for STIs ( chlamydia , gonorrhoea , syphilis and HIV ) and viral hepatitis ( hepatitis B and C ) , received HIV and STI prevention education and were randomized into four groups : ( @ ) control , ( @ ) medium conditional incentive ( $ @/six months ) , ( @ ) high conditional incentive ( $ @/six months ) and ( @ ) unconditional incentive ( $ @/six months ) .


In the conditional arms , incentives were contingent upon testing free of new curable STIs ( chlamydia , gonorrhoea and syphilis ) at follow-up assessments .


Participants ' mean age was @ years ; @ % were homeless or lived in a shelter , @ % were unemployed and @ % lived in Mexico City less than @ years .


At baseline , @ % were living with HIV , and @ % tested positive for viral hepatitis or at least one STI ( other than HIV ) .


Participants had a mean of five male clients in the previous week ; @ % reported condomless sex with their last client .


For @ % , sex work was their main occupation and was conducted mainly on the streets ( @ % ) or in bars/discotheques ( @ % ) and hotels ( @ % ) .


The average price for a sex transaction was $ @ with a @ % higher payment for condomless sex .


The findings suggest that economic incentives are a relevant approach for HIV prevention among MSWs , given the market-based inducements for unprotected sex .


This type of targeted intervention seems to be justified and should continue to be explored in the context of combination prevention efforts .


The benefits of antioxidant micronutrients in slowing progression to advanced stages of age-related macular degeneration ( AMD ) was supported by the @/day tablet form investigated in the Age-related Eye Disease Study @ ( AREDS@ ) and the @/day softgel form in the Age-related Eye Disease Study @ ( AREDS@ ) .


However , the choices of excipient , dosage form , and ingredient chemistry as well as the patient physiologies and pathologies can influence bioavailability and efficacy .


The objective of the study was to explore the influence of dosage form on the bioavailability of the five primary AREDS@ and Tier-@ AREDS@ micronutrients : the metals zinc and copper , - carotene , and vitamins E and C.


The intent was to establish by chemical analysis the relative bioavailabilities of these five micronutrients in plasma , or serum for the metals , as well as to identify any opportunities for improvements .


A total of @ healthy men ( @ ) and women ( @ ) were recruited for a controlled , randomized , three-arm , crossover trial of the AREDS@ micronutrients .


The study investigated responses in bioabsorption to a single dose of either four tablets or two softgels at the full dose level , or one softgel at the half-dose level .


The bioavailability of each micronutrient was based on the pharmacokinetic profiles established through @ samplings for each ingredient/dosage form in plasma/serum over the course of one week .


Bioavailability was estimated using model-independent and model-dependent procedures .


A statistical advantage of the dosage form was observed in only two cases from the exaggerated effects using the half-dose softgel and for the tablet dosage form for - carotene and vitamin E.


An unanticipated complexity was suggested by the bimodal absorption of zinc .


For these micronutrients , no disadvantage ( though potential advantage ) was inferred for the water-soluble components presented in a softgel formulation .


Increased fractional absorption was observed for the smaller dose ( one capsule versus two ) , but it was not sufficient to reach the level achieved by the full dose of either four tablets or two softgels .


A model-dependent analysis permitted an estimation of the percentage of micronutrients absorbed , with zinc , the single most important ingredient , absorbed at about a @ % level .


The results suggest modestly contradictory requirements in the dosage form for water-soluble and lipid-soluble ingredients , as based on a goal of improved bioavailability .


Comparative consistency in bioavailability was observed across dosage forms , and most nutrients between AREDS@ and AREDS@ ( full dose ) formulations relative to the significant variations observed within this controlled population .


The results emphasize the importance of defining the requisite bioavailability of each micronutrient and the influence of the dosage form that provides it .


With the recognition of global and population-specific micronutrient deficiencies , notably in the elderly populations afflicted with AMD and their significant metabolic and health consequences , establishing efficient means of supplementation are of continuing epidemiologic interest .


To assess the impact of low-concentration contrast medium on vascular enhancement , image quality and radiation dose of coronary CT angiography ( cCTA ) by using a combination of iterative reconstruction ( IR ) and low-tube-voltage technique .


One hundred patients were prospectively randomized to two types of contrast medium and underwent prospective electrocardiogram-triggering cCTA ( Definition Flash , Siemens Healthcare ; collimation : @ mm @ mm ; tube current : @ mAs ) .


Fifty patients received Iopromide @ were scanned using the conventional tube setting ( @ kVp or @ kVp if BMI @ kg/m ( @ ) ) and reconstructed with filtered back projection ( FBP ) .


Fifty patients received Iodixanol @ were scanned using the low-tube-voltage ( @ kVp or @ kVp if BMI @ kg/m ( @ ) ) technique and reconstructed with IR .


CT attenuation was measured in coronary artery and other anatomical regions .


Noise , image quality and radiation dose were compared .


Compared with two Iopromide @ subgroups , Iomeprol @ subgroups showed no significant difference in CT attenuation ( @ @ vs. @ @ for BMI < @ kg/m ( @ ) , p = @ and @ @ vs. @ @ for BMI @ kg/m ( @ ) , p = @ ) , noise ( in various anatomical regions of interest ) and image quality ( @ vs. @ , p = @ ) , but significantly ( @ @ vs. @ @ for BMI < @ kg/m ( @ ) , p < @ and @ @ vs. @ @ for BMI @ kg/m ( @ ) , p < @ ) lower radiation dose , which reflects dose saving of @ % and @ % , respectively .


Combined IR with low-tube-voltage technique , a low-concentration contrast medium of @ mg I/ml can still maintain the contrast enhancement without impairing image quality , as well as significantly lower the radiation dose .


To test the hypothesis that those who are highly tolerant to lower body negative pressure ( LBNP ) while normothermic are also highly tolerant to this challenge while hyperthermic .


Sixty pairs of normothermic and hyperthermic LBNP tests to pre-syncope were evaluated .


LBNP tolerance was quantified via the cumulative stress index ( CSI ) , which is calculated as the sum of the product of the LBNP level and the duration of each level until test termination ( i.e. , @mmHg@min +@ mmHg@min , etc. ) .


CSI was compared between normothermic and hyperthermic trials .


Internal and skin temperatures , heart rate , and arterial pressure were measured throughout .


Hyperthermia reduced ( P < @ ) CSI from @ to @mmHgmin .


There was a positive correlation between normothermic and hyperthermic LBNP tolerance ( R ( @ ) = @ ; P < @ ) .


As a secondary analysis , the @ trials with the highest LBNP tolerance while normothermic were identified ( indicated as the HIGH group ; CSI @,@ mmHgmin ) , as were the @ trials with the lowest normothermic tolerance ( indicated as the LOW group ; CSI @mmHgmin ; P < @ between groups ) .


While hyperthermia unanimously reduced CSI in both HIGH and LOW groups , in this hyperthermic condition CSI was ~ threefold higher in the HIGH group ( @mmHgmin ) relative to the LOW group ( @mmHgmin ; P < @ ) .


LBNP tolerance while hyperthermic is related to normothermic tolerance and , associated with this finding , those who have a high LBNP tolerance while normothermic remain relatively tolerant when hyperthermic .


Evaluate the role of midwife with no experience in assisting ultrasound guided embryo transfer .


A prospective randomized study comparing results of IVF after ultrasound guided embryo transfer ( ET ) assisted either by a midwife with no formal training in US , or by a doctor trained to guide .


ET procedure was performed on @ patients undergoing ultrasound guided ET .


The number of embryos transferred , the pregnancy rate ( PR ) , the incidence of extrauterine pregnancy , ongoing pregnancy rate , the implantation rate ( IR ) , difficulty of embryo transfer and quality of US assistance were compared among the groups .


No significant differences were observed between the two groups regarding the number of embryos transferred ( @ +@ Group A vs @ +@ Group B ) implantation rate ( @ % Group A vs @ % Group B ) , pregnancy rate ( @ % Group A vs @ % Group B ) , ongoing pregnancy rate ( @ % Group A vs @ % Group B ) , and rate of extrauterine pregnancies ( @ % Group A vs @ % Group B ) .


Difficult transfers ( @ % Group A vs @ % Group B ) and unsatisfactory visualization of uterus and catheter ( @ % Group A vs @ % Group B ) were also similar in both groups of patients .


Having an inexperienced nurse or midwife to perform ultrasound guidance during ET does not markedly affect the clinical results compared to using experienced clinicians for this purpose .


To explore the clinical effects of nimotuzumab combined with chemotherapy in the treatment of late gastric cancer .


A total of @ reoccurrence or metastatic patients with late stage gastric cancer who were confirmed by histopathology and/or cytology were selected and randomly divided into observational and control groups , of @ cases each .


Patients in the control group were treated with the standard DCF plan , while patients in observational group additionally received nimotuzumab .


The short-term and long-term efficacy and adverse reactions in the @ groups were followed .


The objective response rate ( ORR ) and disease control rate ( DCR ) were @ % ( @/@ ) and @ % ( @/@ ) in observational group and @ % ( @/@ ) and @ % ( @/@ ) in the control group ( ORR and DCR between @ groups , @ = @ , P = @ and @ = @ , P = @ ) .


The median progression-free survival ( PFS ) time and median overall survival ( OS ) time were @ months and @ months in observational group and @ months and @ months in the control group ( P = @ ; P = @ ) .


The main toxic and side effects in the @ groups were reduced leukocytes and hemoglobin , gastrointestinal reactions and hair loss and these were relieved after symptomatic treatment and nutrition support therapy .


There were no differences in the occurrence of toxic and side effects between the @ groups .


Nimotuzumab combined with DCF plan is effective in treating late stage gastric cancer .


A larger scale study is now warranted for confirmation of the findings .


The JFMC@-@ trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil-tegafur ( UFT ) plus leucovorin in patients with stage IIB or III colon cancer .


We report the interim results of preplanned safety analyses .


Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT ( @ mg/m ( @ ) ) plus leucovorin ( @ mg/day ) for @ months ( control group , @ weeks of treatment followed by a @-week rest , five courses ) or for @ months ( study group , @ days of treatment followed by a @-day rest , @ courses ) .


Treatment status and safety were evaluated .


A total of @,@ patients were enrolled , and @,@ were included in safety analyses .


Treatment completion rate at @ months was @ % in the control group and @ % in the study group .


Treatment completion rate in the study group at @ months was @ % .


The overall incidence of adverse events ( AEs ) was @ % in the control group and @ % in the study group .


The incidences of grade @ or higher AEs were low in both groups .


During the first @ months , the incidences of the subjective AEs were significantly lower in the study group .


Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy .


In particular , @ days of treatment followed by a @-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than @ months .


Image-enhanced endoscopy , such as narrow band imaging and the Storz Professional Image Enhancement System , have been increasingly used in patients with suspect lesions of the larynx and hypopharynx during preoperative and intraoperative assessment .


In the present study , a contact endoscope was coupled with the systems of image-enhanced endoscopy , as to precisely distinguish the peculiar neoangiogenetic changes in inflammation , and precancerous and cancerous lesions of the larynx and hypopharynx .


We performed a single-blind study with this original approach of a series of @ patients with different lesions of the larynx and hypopharynx .


We observed five obvious vascular patterns matching the diagnosis in @ patients out of @ , with accuracy in the differential diagnosis between normal tissue and hyperplasia versus mild dysplasia and carcinoma of @ % .


Enhanced contact endoscopy allows for predicting histologic changes of laryngeal and hypopharyngeal lesions from inflammation to cancer on based on fine evaluation of the neoangiogenetic changes of the chorion .


This innovative procedure can be considered an important tool during diagnosis , treatment , and follow-up of patients with precancer and cancer of the larynx and hypopharynx .


Little is known about the effect of inhaled corticosteroids ( ICS ) / long-acting beta@ agonists ( LABA ) in combination on inflammatory markers in asthma .


In addition , therapeutic equivalence of generic salmeterol/fluticasone combination ( SFC ) and original SFC is as yet unknown .


To determine the effects of SFC and the effects of generic and original SFC on airway inflammation in patients with mild-to moderate stable asthma .


A randomized double-blinded , crossover non-inferiority study was conducted to compare the antiinflammatory effects of generic SFC and original SFC on sputum eosinophils as a primary outcome and fractional exhaled nitric oxide ( FENO ) as a secondary outcome .


The authors studied @ mild-to-moderate asthmatic patients who ranged from @ to @ years of age and were treated with ICS or ICS/LABA of any dose , and whose asthma was stable without an exacerbation episode for at least @ months prior to study entry .


Both sputum eosinophils percentage and absolute eosinophil counts well correlated with FENO levels at baseline prior to the initiation of study medications .


Significant reduction in sputum eosinophil percentage was observed following generic SFC and original SFC treatment .


The degree of sputum eosinophil suppression by generic SFC was not inferior to original SFC , and this was not affected by treatments with the sequence of generic SFC first vs. original SFC second or original SFC first vs. generic SFC. In addition , there was no significant difference between treatments in terms of normalized gain in asthma control scores , including the number of patients found to have improved asthma control , irrespective of sequence , as change from baseline .


However , this was not the case for the magnitude of FENO reduction that occurred after generic SFC treatment to a significantly larger extent than original SFC treatment .


This short-term study demonstrated that there was no significant difference between generic SFC and original SFC in terms of anti-inflammatory activity and the control of asthma symptoms .


However , it is completely unknown whether generic SFC could effectively prevent the development of asthma exacerbations on a long-term basis .


Therefore , longer-term studies are indicated to evaluate generic SFC 's relative efficacy on asthma exacerbations .


Evaluate the safety and efficacy of longterm abatacept ( ABA ) treatment over @ years in methotrexate ( MTX ) - refractory patients with rheumatoid arthritis ( RA ) .


Patients from the @-year , double-blind Abatacept in Inadequate Responders to Methotrexate ( AIM ) study ( NCT@ ) received open-label ABA ( @ mg/kg ) in the longterm extension ( LTE ) .


Safety was assessed for patients who received @ ABA dose , and efficacy for patients randomized to ABA and treated in the LTE .


Radiographs were evaluated for changes in Genant-modified Sharp scores .


Out of @ patients , @ entered the LTE ( ABA , n = @ ; placebo , n = @ ) .


At Year @ , @ % were ongoing ; discontinuation rates declined over time .


Incidence rates of serious adverse events , serious infections , malignancies , and autoimmune events were @ , @ , @ , and @ events/@ patient-years exposure , respectively .


American College of Rheumatology @ response was @ % ( n = @ ) and @ % ( n = @ ) at years @ and @ , respectively .


Disease Activity Score @ C-reactive protein ( DAS@-CRP ) < @ and @ were achieved by @ % and @ % of patients at Year @ ( n = @ ) , and @ % and @ % at Year @ ( n = @ ) , respectively .


Mean changes in DAS@-CRP and Health Assessment Questionnaire-Disability Index at Year @ -LSB- -@ ( n = @ ) and -@ ( n = @ ) -RSB- were maintained at Year @ -LSB- -@ ( n = @ ) and -@ ( n = @ ) -RSB- for patients continuing treatment .


Of them , @ % ( n = @ ) and @ % ( n = @ ) remained free from radiographic progression at years @ and @ , respectively .


In MTX-refractory patients with RA , longterm ABA treatment was well tolerated and provided consistent safety and sustained efficacy , with high patient retention .


Radiographic progression continued to be inhibited with ongoing treatment .


To determine whether field photodynamic therapy ( PDT ) of actinic keratoses ( AKs ) using a novel preparation of @-aminolevulonic acid ( ALA ) would result in fewer subsequent invasive skin cancers developing on the face .


A prospective multi-center randomized controlled trial .


The protocol was approved by the Bond University Human Research Ethics Committee in accord with the TGA 's Clinical Trial Notification Scheme .


The trial was registered ( @ ) on the Australian New Zealand Clinical Trials Registry .


Six centers in four states in Australia .


Two treatments of ALA PDT , @ weeks apart for each patient .


Controls were observed .


Patients were followed up with biopsies of any suspicious lesions every @ months for @ years .


Development of new skin cancers .


The trial was suspended after @ months and closed after @ months after ethics committee approval was withdrawn on the basis of a breakdown in trial governance .


Over the following @ years , some investigators noted and formally reported the continued occurrence of serious adverse events in excess of those described with other approved cutaneous PDT treatments .


USA dermatologists with experience managing AKs with FDA approved ALA products subsequently confirmed prolonged and severe adverse events in @ of the former trial intervention patients .


Adverse effects experienced by patients using the investigational ALA PDT appeared more severe than those experienced when an FDA-approved ALA product is used .


We believe the former should be further evaluated for safety .


It is of concern that this ALA product and lamp could be promoted and used widely in Australia following these reports of significant adverse events and continued lack of TGA approval .


Childhood obesity can cause the development of cardiovascular risk factors .


We assessed the effect of a multidisciplinary intervention program on cardiovascular risk factors and compared this effect with a usual-care program in @ - to @-y-old overweight or obese children .


Seventy-five children were randomly assigned to a multidisciplinary intervention or a usual-care program .


Anthropometry , body composition , and abdominal adipose tissue were assessed at the start and end of a @-wk program .


Concurrently , fasting concentrations of serum lipids , glucose , insulin , HbA@c , leptin , adiponectin , high-sensitive C-reactive protein ( hsCRP ) , tumor necrosis factor ( TNF ) - , and interleukin ( IL ) -@ were determined .


In both groups , insulin sensitivity improved , demonstrated by decreased insulin concentrations and a decreased HOMA@-IR .


In the multidisciplinary intervention group , there was also a decrease of HbA@c and TNF - .


In the usual-care group , an increase in glucose concentrations was found .


Comparing both groups , changes over time were not different , besides trends in the decrease in total cholesterol and TNF - , in favor of the multidisciplinary intervention group .


Combining the results of both groups , a correlation was found between the decrease in body fat percentage ( BF % ) , and both HOMA@-IR and triglyceride ( TG ) concentrations .


In @ - to @-y-old children , both obesity intervention programs improved insulin sensitivity , in parallel with a reduced BF % .


Over the last decade , image guidance systems have been widely adopted in neurosurgery .


Nonetheless , the evidence supporting the use of these systems in surgery remains limited .


The aim of this study was to compare simultaneously the effectiveness and safety of various image guidance systems against that of standard surgery .


In this preclinical , randomized study , @ novice surgeons were allocated to one of the following groups : @ ) no image guidance , @ ) triplanar display , @ ) always-on solid overlay , @ ) always-on wire mesh overlay , and @ ) on-demand inverse realism overlay .


Each participant was asked to identify a basilar tip aneurysm in a validated model head .


The primary outcomes were time to task completion ( in seconds ) and tool path length ( in mm ) .


The secondary outcomes were recognition of an unexpected finding ( i.e. , a surgical clip ) and subjective depth perception using a Likert scale .


The time to task completion and tool path length were significantly lower when using any form of image guidance compared with no image guidance ( p < @ and p = @ , respectively ) .


The tool path distance was also lower in groups using augmented reality compared with triplanar display ( p = @ ) .


Always-on solid overlay resulted in the greatest inattentional blindness ( @ % recognition of unexpected finding ) .


Wire mesh and on-demand overlays mitigated , but did not negate , inattentional blindness and were comparable to triplanar display ( @ % recognition of unexpected finding in all groups ) .


Wire mesh and inverse realism overlays also resulted in better subjective depth perception than always-on solid overlay ( p = @ and p = @ , respectively ) .


New augmented reality platforms may improve performance in less-experienced surgeons .


However , all image display modalities , including existing triplanar displays , carry a risk of inattentional blindness .


Fluid displacement from the legs during recumbency while in bed might narrow the upper airway ( UA ) in association with nuchal fluid accumulation that may contribute to the pathogenesis of obstructive sleep apnea ( OSA ) .


The aim of this study was to test the hypothesis that rostral fluid displacement from the legs causes a greater decrease in UA cross-sectional area ( UA-XSA ) and a greater increase in UA mucosal water content ( UA-MWC ) and internal jugular venous volume ( IJVVol ) in subjects with OSA than in those without OSA .


Subjects underwent baseline assessment of leg fluid volume ( LFV ) measured by bio-electrical impedance , as well as UA-XSA and UA-MWC by magnetic resonance imaging .


They were then randomly assigned to a @-min period either with or without application of lower body positive pressure ( LBPP ) of @ mm Hg , followed by a @-min washout period , after which they crossed over to the other arm of the study .


Measurements of LFV , UA-MWC , and UA-XSA were repeated after each arm of the study .


In @ subjects without sleep apnea , UA-XSA increased and UA-MWC decreased significantly , whereas in @ subjects with OSA , UA-XSA decreased and UA-MWC increased significantly in response to LBPP .


The changes in UA-XSA and UA-MWC in response to LBPP differed significantly between the @ groups ( p = @ and p < @ , respectively ) , despite similar changes in LFV and IJVVol .


Our results suggest that rostral fluid shift may contribute to the pathogenesis of OSA at least partly through narrowing of the UA due to transudation of fluid into the UA mucosa .


To test the hypothesis that the use of a harmonic scalpel increases operative time but results in less estimated blood loss , postoperative pain , drainage volume , and duration of surgery , as well as fewer complications , such as flap necrosis , seroma , and surgical site infection ( SSI ) , than electrocautery .


This parallel-group , single-institution blinded randomized controlled trial was conducted at the department of surgery of our institute between April @ and July @ .


Women undergoing modified radical mastectomy were randomly allocated to either harmonic dissection ( n = @ ) or electrocautery ( n = @ ) .


Both the groups were comparable for baseline variables with age of @ @ and @ @ years in the harmonic and electrocautery groups , respectively .


Harmonic dissection yielded better outcomes compared to electrocautery with lower estimated blood loss ( @ @ vs. @ @ , p < @ ) , less drain volume ( @ @ ml vs. @ @ ml , p < @ ) , fewer drain days ( @ @ vs. @ @ , p < @ ) , less seroma formation ( @ vs. @ % , p = @ ) , and less postoperative pain -LSB- median ( interquartile range ) @ ( @-@ ) vs. @ ( @-@ ) , p < @ -RSB- , whereas mean operative time ( @ @ vs. @ @ min , p = @ ) and SSI ( @ vs. @ % , p = @ ) did not differ .


On multivariable Cox regression analysis , harmonic dissection was associated with lower risk of significant postoperative pain -LSB- adjusted relative risk @ ( @ % confidence interval ( CI ) @-@ @ ) -RSB- and overall complications -LSB- adjusted relative risk @ , ( @ % CI @-@ @ ) -RSB- .


On multiple linear regression , duration of drains in the harmonic dissection group was @ days less than electrocautery ( r@ = @ , = @ , p < @ ) .


The harmonic scalpel significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time .


We thus recommend preferential use of harmonic dissection in modified radical mastectomy .


( ClinicalTrials.gov NCT@ ) .


The prevalence of metabolic syndrome ( MetS ) and obesity has increased worldwide , as well as in Taiwan , particularly in women aged > @ years .


The purpose of this study was to elucidate the effects of a calorie-restriction diet ( CR ) supplemented with protein and n-@ polyunsaturated fatty acids ( PUFAs ) on women with MetS .


A total of @ eligible female participants were recruited and assigned to four dietary interventions such as @-kcal CR , calorie-restriction meal-replacement diet ( CRMR ) , calorie-restriction diet with fish oil supplementation ( CRF ) and calorie-restriction meal-replacement diet with fish oil supplementation ( CRMRF ) .


The changes in anthropometric measures , metabolic profiles , inflammatory response and the Z-score of severity of MetS were evaluated .


Among @ female MetS patients enrolled , @ patients completed the @-week study .


After the @-week dietary interventions , we observed reductions in body weight ( BW ) , body mass index ( BMI ) and waist circumference ( WC ) in all groups .


BMI and triglyceride ( TG ) levels decreased significantly in the CRMR , CRF and CRMRF groups , but not in the CR group .


The homeostasis model assessment of insulin resistance ( HOMA-IR ) had significantly improved in all four groups , and the levels of interleukin-@ ( IL-@ ) and C-reactive protein ( CRP ) had significantly decreased in the CRF and CRMRF groups .


Following the interventions , the changes in waist circumference ( WC ) , mean arterial pressure ( MAP ) , fasting blood glucose ( FBG ) , TGs , HOMA-IR , CRP and IL-@ significantly correlated with the reductions in Z-score of MetS severity .


Our study results indicate that a calorie-restriction dietary intervention combined with various macronutrients can reduce the severity of MetS in women and increase recovery from MetS by almost twofold in comparison with a CR alone .


Driving is a complex task and distractions such as using a mobile phone for the purpose of text messaging are known to have a significant impact on driving .


Eating and drinking are common forms of distraction that have received less attention in relation to their impact on driving .


The aim of this study was to further explore and compare the effects of a variety of distraction tasks ( i.e. , text messaging , eating , drinking ) on simulated driving .


Twenty-eight healthy individuals ( @ female ) participated in a crossover design study involving @ experimental trials ( separated by @ h ) .


In each trial , participants completed a baseline driving task ( no distraction ) before completing a second driving task involving one of @ different distraction tasks ( drinking @ mL water , drinking @ mL water and eating a @-inch Subway sandwich , drinking @ mL water and composing @ text messages ) .


Primary outcome measures of driving consisted of standard deviation of lateral position ( SDLP ) and reaction time to auditory and visual critical events .


Subjective ratings of difficulty in performing the driving tasks were also collected at the end of the study to determine perceptions of distraction difficulty on driving .


Driving tasks involving texting and eating were associated with significant impairment in driving performance measures for SDLP compared to baseline driving ( @ @ vs. @ @ cm and @ @ vs. @ @ cm , respectively ) , number of lane departures compared to baseline driving ( @ @ vs. @ @ and @ @ vs. @ @ , respectively ) , and auditory reaction time compared to baseline driving ( @ @ vs. @ @ ms and @ @ vs. @ @ ms , respectively ) .


No difference in SDLP ( @ @ vs. @ @ cm ) , number of lane departures ( @ @ vs. @ @ ) , or auditory reaction time ( @ @ and @ @ ms ) was observed in the drive involving the drink-only condition compared to the corresponding baseline drive .


No difference in reaction time to visual stimuli was observed between baseline and experimental drives for any of the trial conditions .


Participants ' subjective ratings indicated that they perceived the texting while driving condition to be the most difficult despite similar magnitudes of impairment observed with the eating while driving condition .


Distracting behaviors such as eating and texting while driving appear to negatively impact driving measures of lane position control and reaction time .


These findings may have direct implications for motorists that engage in these types of distracting behaviors behind the wheel and for the safety of other road users .


Open abdominal aortic aneurysm ( AAA ) repair is followed by a high rate of incisional herniation .


The purpose of this study was to evaluate whether this postoperative complication could be avoided by a prophylactic implantation of a biological mesh .


In a prospective randomized clinical study , patients electively treated by open AAA repair were allocated equally to routine abdominal suture closure or to prophylactic placement of bovine pericardium mesh above the fascia .


The study end points were postoperative complications and incidence of incisional hernia at a @-year follow up .


Forty patients with a mean age of @ ( SD @ ) years were studied .


All patients had a successful operation and a quite uneventful postoperative course .


The mean operative time in the mesh group was longer compared to the control group ( p < @ ) .


Two patients in the mesh group developed wound seroma postoperatively .


Six patients ( @ % ) in the control group developed incisional hernia comparing to none in the mesh group .


Cumulative proportion of freedom from incisional hernia was @ % for mesh group at @ years and @ % ( SE @ % ) for control group at @ years ( p < @ ) .


In five patients ( @ % ) , the incisional hernia was diagnosed by the second postoperative year .


One patient underwent incisional hernia repair .


The bovine pericardium mesh reinforcement of fascia closure in patients undergoing open AAA repair showed effectiveness and low complication rate in prophylaxis from incisional herniation .


It should be considered as an alternative mesh material in selected patients .


The therapeutic arsenal for MRSA infections is limited .


The aim of this study was to assess the non-inferiority of a combination of trimethoprim/sulfamethoxazole plus rifampicin versus linezolid alone for the treatment of MRSA infection .


We conducted a randomized , open-label , single-centre , non-inferiority trial comparing trimethoprim/sulfamethoxazole ( @ mg/@ mg three times daily ) plus rifampicin ( @ mg once a day ) versus linezolid ( @ mg twice a day ) alone in adult patients with various types of MRSA infection .


Patients were allocated @:@ to either regimen .


The primary outcome was clinical cure at @ weeks after the end of treatment ( non-inferiority margin @ % ) assessed by both ITT and PP analyses .


Secondary outcomes included the microbiologically documented persistence of MRSA in clinical cultures , mortality and adverse events .


The study protocol has been registered with ClinicalTrials.gov ( NCT@ ) .


Overall , @ patients were randomized to one of the two treatment arms between January @ and December @ and were included in the ITT analysis .


Of these @/@ ( @ % ) in the linezolid group and @/@ ( @ % ) in the trimethoprim/sulfamethoxazole and rifampicin group experienced clinical success ( risk difference @ % , @ % CI -@ % to @ % ) .


The results were confirmed by the PP analysis , with @/@ ( @ % ) cured patients in the linezolid group versus @/@ ( @ % ) in the trimethoprim/sulfamethoxazole and rifampicin group ( risk difference @ % , @ % CI -@ % to @ % ) .


There were no statistically significant differences between the two groups in any of the secondary outcomes , including microbiologically documented failure .


Four adverse drug reactions attributed to the study medication occurred in the linezolid group versus nine in the trimethoprim/sulfamethoxazole and rifampicin group .


Compared with linezolid , trimethoprim/sulfamethoxazole and rifampicin seems to be non-inferior in the treatment of MRSA infection .


Antiretroviral therapy initiation for HIV-@ infection is associated with @ % to @ % loss of bone mineral density ( BMD ) .


To evaluate the effect of vitamin D@ plus calcium supplementation on bone loss associated with antiretroviral therapy initiation .


@-week prospective , randomized , double-blind , placebo-controlled study .


( ClinicalTrials.gov : NCT@ ) .


@ AIDS Clinical Trials Group units .


Adults with antiretroviral therapy-naive HIV .


BMD by dual-energy x-ray absorptiometry , @-hydroxyvitamin D levels , and other laboratory assessments .


@ eligible patients were randomly assigned ( @ received vitamin D@ plus calcium and @ received placebo ) .


The study groups were well-balanced at baseline : @ % were men , @ % were non-Hispanic black , and the median CD@ count was @ @ cells/L .


At @ weeks , the percentage of decline in total hip BMD was smaller in the vitamin D@ plus calcium group than in the placebo group : Medians were -@ % ( interquartile range -LSB- IQR -RSB- , -@ % to @ % ) and -@ % ( IQR , -@ % to -@ % ) , respectively ( P = @ ) .


Similar results were seen at the lumbar spine .


At @ weeks , @ % of patients achieved HIV-@ RNA levels less than @ copies/mL .


Levels of @-hydroxyvitamin D@ increased with vitamin D@ plus calcium but not with placebo : Median change was @ nmol/L ( IQR , @ to @ ) versus @ nmol/L ( IQR , -@ to @ ) ( P < @ ) .


Overall , @ patients ( @ % ) reported @ or more adverse event , with similar distribution between groups ; no cases of hypercalcemia and @ case of nephrolithiasis were reported in the placebo group .


No international sites were included , and follow-up was only @ weeks .


Vitamin D@ plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate .


This article describes an experiment that was designed to investigate the effects of sleep deprivation on physiological stress responses in healthy adults .


Twenty-six participants , ages @-@ , completed a @-night laboratory experiment with randomization to one night of sleep-deprivation or a normal-sleep control condition .


After a night of baseline sleep , @ participants were sleep deprived and @ were not .


After the sleep manipulation , each participant completed the Trier Social Stress Test , a task that requires delivering a speech and performing difficult arithmetic in front of a stern , three-person panel .