Eight hundred-five ( @ ) adults were enrolled .


All combinations of vaccines were safe and well tolerated .


In general , one dose of @-H@N@ and one dose of IIV@ , regardless of sequence or concurrency of administration , were immunogenic in adults .


There were no significant differences in geometric mean titers ( GMT ) or the proportions of subjects with @-fold rise in antibody responses and titers @ for any vaccine group or between age strata for @-H@N@ after the first or second dose , although the vaccine sequence affected the titers to the IIV@ antigens .


Hemagglutination inhibition antibody ( HAI ) GMTs against @-H@N@ for the combined age strata @ days after the first @-H@N@ dose were @ , @ , @ and @ for HP/HP/V@ , HV@/HP/P , HP/HV@/P and V@P/HP/H , respectively .


While IIV@ GMTs were adequate they were generally lower than the @-H@N@ GMTs .


In a subset of subjects , there was good correlation between HAI and microneutralization ( MN ) titers ( Spearman 's correlation coefficient @ ) .


All vaccine combinations were generally well tolerated .


Immune responses to one dose of @-H@N@ were adequate regardless of the sequence of vaccination in all age groups , but the sequence affected titers to IIV@ antigens .


To determine whether children with calcium-deficiency rickets respond better to treatment with calcium as limestone or as ground fish .


Nigerian children with active rickets ( n = @ ) were randomized to receive calcium as powdered limestone ( @ mg of elemental calcium ) or ground fish ( @ mg of elemental calcium ) daily for @ weeks .


Radiographic healing was defined as achieving a score of @ or less on a @-point scale .


The median ( range ) age of enrolled children was @ ( @-@ ) months .


Of the @ children who completed the study , @ ( @ % ) in the ground fish group and @ ( @ % ) in the limestone group achieved the primary outcome of a radiographic score of @ or less within @ months ( P = @ ) .


The mean radiographic score improved from @ @ to @ @ in the ground fish group and from @ @ to @ @ in the limestone group ( P = @ for group comparison ) .


In an intention to treat analysis adjusted for baseline radiographic score , age , milk calcium intake , and serum @-hydroxyvitamin D concentration , the response to treatment did not differ between the @ groups ( P = @ ) .


Younger age was associated with more complete radiographic healing in the adjusted model ( aOR @ -LSB- @ % CI @-@ @ -RSB- ) .


After @ weeks of treatment , serum alkaline phosphatase had decreased , calcium and @-hydroxyvitamin D increased , and bone mineral density increased in both groups , without significant differences between treatment groups .


In children with calcium-deficiency rickets , treatment with calcium as either ground fish or limestone for @ months healed rickets in the majority of children .


To compare the efficacy of duloxetine with placebo on depression in elderly patients with major depressive disorder .


Multicenter , @-week ( @-week short-term and @-week continuation ) , randomized , placebo-controlled , double-blind trial .


United States , France , Mexico , Puerto Rico .


Age @ years or more with major depressive disorder diagnosis ( one or more previous episode ) ; Mini-Mental State Examination score@ ; Montgomery-Asberg Depression Rating Scale total score@ .


Duloxetine @ or @ mg/day or placebo ; placebo rescue possible .


Primary-Maier subscale of the @-item Hamilton Depression Rating Scale ( HAMD-@ ) at week @ .


Secondary-Geriatric Depression Scale , HAMD-@ total score , cognitive measures , Brief Pain Inventory ( BPI ) , Numeric Rating Scales ( NRS ) for pain , Clinical Global Impression-Severity scale , Patient Global Impression of Improvement in acute phase and acute plus continuation phase of treatment .


Compared with placebo , duloxetine did not show significantly greater improvement from baseline on Maier subscale at @ weeks , but did show significantly greater improvement at weeks @ , @ , @ , and @ .


Similar patterns for Geriatric Depression Scale and Clinical Global Impression-Severity scale emerged , with significance also seen at week @ .


There was a significant treatment effect for all BPI items and @ of @ NRS pain measures in the acute phase , most BPI items and half of the NRS measures in the continuation phase .


More duloxetine-treated patients completed the study ( @ % versus @ % ) .


A significantly higher percentage of duloxetine-treated patients versus placebo discontinued due to adverse event ( @ % versus @ % ) .


Although the antidepressant efficacy of duloxetine was not confirmed by the primary outcome , several secondary measures at multiple time points suggested efficacy .


Duloxetine had significant and meaningful beneficial effects on pain .


Patients with primary cutaneous melanomas that are ulcerated and > @ mm in thickness , > @ mm in thickness and those with nodal micrometastases at diagnosis , have few options for adjuvant treatment .


Recent studies have suggested a role for vitamin D to delay melanoma recurrence and improve overall prognosis .


This is a pilot placebo-controlled randomised phase II trial to assess the feasibility , safety and toxicity of an oral loading dose of Vitamin D ( @,@ IU ) followed by an oral dose of @,@ IU of Vitamin D monthly for @ years in patients who have been treated for cutaneous melanoma by wide excision of the primary .


Patients aged @-@ years who have completed primary surgical treatment and have Stage IIb , IIc , IIIa ( N@a , N@a ) or IIIb ( N@a , N@a ) disease are eligible for randomisation @:@ to active treatment or placebo .


The primary endpoints are sufficiency of dose , adherence to study medication and safety of the drug .


The secondary endpoints are participation and progression free survival .


The study has been approved by the Ethics Review Committee ( RPAH Zone ) of the Sydney Local Health District , protocol number X@-@ .


Effective , non-toxic adjuvant therapy for high risk primary melanoma is not currently available .


Favorable outcomes of this phase II study will form the basis for a multi-centre phase III study to assess whether the addition of oral high-dose vitamin D therapy in patients who have completed primary treatment for melanoma and are at high risk of recurrence will : @ .


prolong time to recurrence within @ years @ .


improve overall survival at @ years and @ .


be both safe and tolerable .


@ patients have been randomised since the study commenced in December @ .


Target accrual for the study has been met with @ patients randomised between December @ and August @ .


The Mel-D trial is conducted by the Australia and New Zealand Melanoma Trials Group ( ANZMTG @ ) TRIAL REGISTRATION : Australia and New Zealand Clinical Trials Registry ( ANZCTR ) ACTRN@ .


Acute kidney failure after coronary artery bypass grafting ( CABG ) is a serious complication that increases morbidity and mortality rates .


Early detection and prevention of this complication are very important .


A novel biomarker named neutrophil gelatinase-associated lipocalin ( NGAL ) can play an important role in early diagnosis of acute kidney injury .


Recent studies on the favourable effects of Dexmedetomidine on cardiac surgery have been published .


The aim of this study is to investigate whether there is a dose-dependent positive effect of Dexmedetomidine on neutrophil gelatinase-associated lipocalin levels and renal functions when used after CABG .


Our randomized , triple-blinded , placebo-controlled study was conducted among @ patients scheduled for CABG surgery between August @ and March @ in a tertiary cardiac and vascular surgery clinic .


A total of @ consecutive patients who met inclusion criteria were randomized and divided into three groups .


The first group received a placebo .


The second and the third groups received @ and @ g/cc concentration of the Dexmedetomidine infusion , respectively .


Infusion rates were regulated to obtain sedation with a Ramsey sedation score of @ or @ .


Patients were regrouped according to the total Dexmedetomidine dose .


Statistical analyses of variables including serum neutrophil gelatinase-associated lipocalin values and conventional renal function tests were made for all six possibilities before the blind was broken .


Results of conventional renal function tests were not significantly different .


However , neutrophil gelatinase-associated lipocalin levels for the first postoperative day for placebo , low-dose and high-dose Dexmedetomidine groups were @ @ , @ @ and @ @ ng/ml , respectively .


These values were significantly different among the groups ( P < @ ) .


In our study , we found that Dexmedetomidine infusion for sedation after CABG under cardiopulmonary bypass can be useful in the prevention of kidney injury .


Conventional renal function tests , including blood urea nitrogen , serum creatinine , urine output and creatinine clearance rate measurements typically may not detect the development of acute kidney dysfunction in the first @-h postoperative period .


Differences were detected in renal function in the early postoperative period and the development of acute kidney injury , as determined by measurements of blood NGAL levels , was significant and dose-dependent .


To report the efficacy of transcutaneous functional electrical stimulation ( FES ) in children with refractory neuropathic urinary incontinence secondary to myelomeningocele ( MMC ) .


Thirty children with history of MMC ( @ girls and @ boys , mean age @ @ years ) with refractory urinary incontinence were enrolled in this study .


They were randomly allocated to treatment ( FES , @ children ) and control ( sham stimulation , @ children ) groups .


All patients underwent urodynamic study ( UDS ) before and @ months after FES considering detrusor leak point pressure ( DLPP ) , mean maximal detrusor pressure , and mean maximal bladder capacity .


Daily incontinence score , frequency of pad changing , and enuresis were also assessed before and @ months after treatment .


A @-course FES was performed for @ min and @ times per week .


Children were followed for at least @ months .


Of UDS variables , DLPP increased significantly from @ @ cmH@O before treatment to @ @ cmH@O in treatment group after @ months ( P < @ ) .


Daily incontinence score ( range @-@ ) improved significantly in treatment group from @ @ before treatment to @ @ after treatment compared with sham stimulation group ( P < @ ) .


This type of electrical stimulation is a safe , noninvasive , and effective modality to improve urinary incontinence in myelomeningocele children and can be used at home .


To examine whether maternal-child interaction during feedings was suboptimal in dyads in which the infant had gastroesophageal reflux disease ( GERD ) and to compare massage therapy to a nonmassage therapy sham treatment in improving the mother-child interaction in these dyads .


In this randomized , controlled pilot study , infants received massage therapy ( n = @ ) or a nonmassage touch/holding sham treatment ( n = @ ) .


Mothers , data collectors , and the investigator who scored the feeding observations were blinded to group assignment .


Dyads were recruited from pediatric care providers in the Denver metropolitan area and online advertisements at the University of Colorado .


Treatments were given in the home of the dyad .


Healthy infants , born at @-@ weeks gestational age , were @-@ weeks of age at enrollment ; had a score of at least @ on the Infant Gastroesophageal Reflux Questionnaire-Revised ; and were diagnosed with GERD by their pediatric provider .


Mothers were English speaking and at least @ years of age .


Treatments were given for @ minutes twice weekly for @ weeks .


A certified infant massage therapist administered massage , and a registered nurse or physical therapist experienced with infants administered the control treatment .


Maternal and infant scores on the Nursing Child Assessment of Feeding Scale ( NCAFS ) .


NCAFS scores were significantly lower than national norms .


Small to moderately sized effects showing improvement in the massage group relative to the nonmassage group were seen for Sensitivity to Cues , Social-Emotional Growth Fostering , Cognitive Growth Fostering , and Clarity of Cues ( Cohen d ) and ranged from @ to @ .


Mothers and infants with GERD experience significantly worse interactions than those without GERD .


Massage given twice weekly by a professional trended toward improved interaction during feeding .


Daily maternal administration of massage may have a positive effect on the relationship .


Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy .


It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and , consequently , microbial translocation .


To assess changes in microbial translocation and inflammation after treatment with probiotics ( Saccharomyces boulardii ) in HIV-@-infected patients with virologic suppression .


A double-blind , randomized , placebo-controlled trial was conducted in @ nonconsecutive HIV-@-infected patients with viral load of < @ copies per milliliter for at least @ years .


Patients were randomized to oral supplementation with probiotics or placebo during @ weeks .


Markers of microbial translocation ( lipopolysaccharide-binding protein -LSB- LBP -RSB- and soluble CD@ ) , inflammation ( interleukin @ -LSB- IL-@ -RSB- , tumor necrosis factor alpha , interferon gamma , high-sensitivity C-reactive protein ) , and immunological and clinical data were determined before and after the intervention and @ months after treatment discontinuation .


Quantitative variables were compared using the Mann-Whitney U test , and categorical variables were compared using the Fisher exact test .


After @ weeks of treatment , differences between the probiotic arm and the placebo arm were observed in LBP values ( -@ vs +@ pg/mL ) and IL-@ ( -@ vs +@ pg/mL ) .


These differences were also noted at @ months after treatment withdrawal .


Qualitative analysis was performed , defining a variable as `` decreased '' or `` increased '' from baseline LBP .


A significant decrease of LBP at @ weeks of treatment was observed ( @ % patients in the probiotic group vs @ % in the placebo group , P = @ ) .


Treatment with S. boulardii decreases microbial translocation ( LBP ) and inflammation parameters ( IL-@ ) in HIV-@-infected patients with long-term virologic suppression .


The aims of the study were to assess the efficacy of a multicomponent intervention and evaluate the feasibility and user acceptance of an internet-based home telemedical surveillance system for the evaluation of pain and other key health outcomes in patients with fibromyalgia ( FM ) .


The study involved @ FM patients who were randomised to usual care or the multicomponent exercise programme , which consisted of @ twice-weekly sessions of combined aerobic , muscle strength training exercises and education .


All the patients completed the revised version of the Fibromyalgia Impact Questionnaire ( FIQR ) and the self-administered Fibromyalgia Activity Score ( FAS ) .


A predefined website allowed authorised users to enter data via a personal computer ( PC ) and Internet browser .


The differences between the groups were assessed using the Mann-Whitney U-test and Fisher 's exact test , and the correlations were analysed using Spearman 's rank correlation test .


The multicomponent intervention led to a clinically relevant difference in improvement in comparison with the standard approach .


It markedly improved the FIQR symptom subscale score , significantly increased the time-integrated area under the curve ( AUC ) of the FAS scores , and led to a greater benefit in terms of fatigue and the quality of sleep .


The mean change in the AUC of the total FIQR score closely correlated with the changes in the AUC of the total FAS score .


The multicomponent approach to FM was effective in treating the key symptoms and maintaining the improvements in the short term , and telemonitoring proved to be an easyto-use solution for patient-centred data acquisition .


Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission .


Hydration is a mainstay of treatment , but insufficient evidence exists to guide clinical practice .


We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants .


In this multicentre , open , randomised trial , we enrolled infants aged @-@ months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons ( April @-Oct @ , in @ , @ , and @ ) .


We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes , with three randomly assigned block sizes and stratified by hospital site and age group ( @ - < @ months vs @-@ months ) .


The primary outcome was length of hospital stay , assessed in all randomly assigned infants .


Secondary outcomes included rates of intensive-care unit admission , adverse events , and success of insertion .


This trial is registered with the Australian and New Zealand clinical trials registry , ACTRN@ .


Mean length of stay for @ infants assigned nasogastric hydration was @ h ( SD @ ) compared with @ h ( @ ) for @ infants assigned intravenous hydration ( absolute difference @ h -LSB- @ % CI -@ to @ -RSB- ; p = @ ) .


Rates of admission to intensive-care units , need for ventilatory support , and adverse events did not differ between groups .


At randomisation , seven infants assigned nasogastric hydration were switched to intravenous hydration and @ infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted .


For those infants who had data available for successful insertion , @ ( @ % ) of @ infants in the nasogastric hydration group and @ ( @ % ) of @ infants in the intravenous hydration group required only one attempt for successful insertion .


Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis .


Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration .


To investigate the effect of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients .


After obtaining approval from the Hospital Ethics Committee and informed written consent from all patients , fourty hemicolectomy patients were randomly divided into two even groups .


After anesthesia induction and intubation , patients received ultrasound-guided bilateral transversus abdominis plane block with @ % ropivacaine @ ml ( group A ) or saline ( group B ) .


Post-operative patient-controlled intravenous analgesia with sufentanil was provided to all patients .


Compared with group B , group A had less BP , HR changes at skin incision and needed less intraoperative sufentanil ( ( @ @ ) g/kg vs ( @ @ ) g/kg ) ( P < @ ) to maintain anesthesia .


Group A had lower VAS than group B at @ , @ , @ , @ , @ h after surgery ( P < @ ) , less PCA demand ( @ @ vs @ @ ) ( P < @ ) and less PCA sufentanil consumption ( ( @ @ ) g vs ( @ @ ) g ) ( P < @ ) , thus less post-operative nausea or vomiting and higher satisfaction ( P < @ ) .


No complications associated to transversus abdominis plane block were found .


Ultrasound-guided transversus abdominis plane block provided safe and effective post-operative analgesia for hemicolectomy patients .


Although autoantibodies to cancer antigens are candidates for biomarkers , no comprehensive studies to detect cancer-specific antibodies have been performed .


This study identified autoantibodies in the sera of pancreatic cancer ( PC ) patients using proteomics based on a wheat germ cell-free protein production system .


We constructed a biotinylated protein library of @,@ genes .


Interactions between biotinylated proteins and serum antibodies were detected by AlphaScreen assay .


Relative luminescence signals of each protein in @ PC patients and @ healthy controls were measured , and their sensitivity and specificity for PC were calculated .


Luminescence signals of nine proteins were significantly higher than those of healthy controls , with calcium and integrin binding @ ( CIB@ ) protein showing the greatest significance ( p = @ ) .


Sensitivity , specificity , positive predictive value and negative predictive value of CIB@ autoantibody alone for PC were @ , @ , @ , and @ % , respectively , and @ , @ , @ , and @ % , respectively , when the four most significant proteins were combined .


Presence of these autoantibodies did not vary significantly with other clinicopathological characteristics .


Several autoantibodies , including CIB@ , are potential biomarkers for PC .


Single-incision laparoscopic cholecystectomy ( SILC ) is considered to be less invasive and have less morbidity than conventional laparoscopic cholecystectomy ( CLC ) .


However , there is a relative paucity of data regarding postoperative pain scores in rural Indian populations following SILC .


Also , data pertaining to the applicability of SILC in rural Indian population are scant .


In the present randomized control trial , pain scores after SILC and CLC were evaluated .


Sixty patients with gallstone disease were randomly assigned to one of two groups with @patients each : the CLC group and the SILC group .


Postoperative pain scores were recorded on the visual analog scale at @ hours , @ hours and @ days after surgery .


The patients were comparable with respect to age , sex and BMI .


Operative time was longer for the SILC group ( @ min vs @ min ; P < @ ) .


The pain scores were similar in both groups at @ hours ( @ vs @ ; P = @ ) and @ hours ( @ vs @ ; P = @ ) postoperatively .


On day @ , the SILC group had lower pain scores than the CLC group ( @ vs @ ; P < @ ) .


There was no distinct advantage to SILC with regard to immediate postoperative pain .


Pain was significantly less ( P < @ ) in the SILC group on postoperative day @ .


School-based health centers ( SBHCs ) have been suggested as possible patient-centered medical homes .


Our objectives were to determine , in a low-income , urban population , adolescents ' reasons for visiting SBHCs and the value parents place on SBHC services , and adolescents ' and parents ' assessment of how well SBHCs fulfill criteria for a medical home as defined by the American Academy of Pediatrics .


A cross-sectional , mailed survey of a random sample of @ adolescent SBHC users and @ parents of SBHC users from @ SBHCs in Denver , CO from May to October @ .


Eligible adolescents were registered in an SBHC with @ visit during the @ to @ school year .


Response rates were @ % ( @/@ ) among adolescents and @ % ( @/@ ) among parents .


The top @ reasons for visits were for illness ( @ % ) , vaccines ( @ % ) , and sexual health education ( @ % ) .


Factors reported as very important by > @ % of parents in the decision to enroll their adolescent in an SBHC included clinic offering sick or injury visits , sports physicals , and vaccinations .


More than @ % of adolescents gave favorable responses ( always or usually , excellent or good ) to questions about American Academy of Pediatrics medical home criteria ( accessibility , continuity , comprehensiveness , family-centeredness , coordination , and compassion ) .


Most parents ( @ % ) reported that they could always or usually trust the SBHC provider to take good care of their child ; @ % were satisfied with provider-to-provider communication .


In a low-income urban population , SBHCs met criteria of a medical home from adolescents ' and parents ' perspectives .


Policymakers and communities should recognize that SBHCs play an important role in the medical community , especially for underserved adolescents .


The World Health Organization , governments , and communities agree that community action is likely to reduce risky alcohol consumption and harm .


Despite this agreement , there is little rigorous evidence that community action is effective : of the six randomised trials of community action published to date , all were US-based and focused on young people ( rather than the whole community ) , and their outcomes were limited to self-report or alcohol purchase attempts .


The objective of this study was to conduct the first non-US randomised controlled trial ( RCT ) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data .


We conducted a cluster RCT comprising @ communities in Australia that had populations of @,@-@ ,@ , were at least @ km from an urban centre ( population @,@ ) , and were not involved in another community alcohol project .


Communities were pair-matched , and one member of each pair was randomly allocated to the experimental group .


Thirteen interventions were implemented in the experimental communities from @ to @ : community engagement ; general practitioner training in alcohol screening and brief intervention ( SBI ) ; feedback to key stakeholders ; media campaign ; workplace policies/practices training ; school-based intervention ; general practitioner feedback on their prescribing of alcohol medications ; community pharmacy-based SBI ; web-based SBI ; Aboriginal Community Controlled Health Services support for SBI ; Good Sports program for sports clubs ; identifying and targeting high-risk weekends ; and hospital emergency department-based SBI .


Primary outcomes based on routinely collected data were alcohol-related crime , traffic crashes , and hospital inpatient admissions .


Routinely collected data for the entire study period ( @-@ ) were obtained in @ .


Secondary outcomes based on pre - and post-intervention surveys ( n = @,@ and @,@ , respectively ) were the following : long-term risky drinking , short-term high-risk drinking , short-term risky drinking , weekly consumption , hazardous/harmful alcohol use , and experience of alcohol harm .


At the @ % level of statistical significance , there was insufficient evidence to conclude that the interventions were effective in the experimental , relative to control , communities for alcohol-related crime , traffic crashes , and hospital inpatient admissions , and for rates of risky alcohol consumption and hazardous/harmful alcohol use .


Although respondents in the experimental communities reported statistically significantly lower average weekly consumption ( @ fewer standard drinks per week , @ % CI = -@ to -@ , p = @ ) and less alcohol-related verbal abuse ( odds ratio = @ , @ % CI = @ to @ , p = @ ) post-intervention , the low survey response rates ( @ % and @ % for the pre - and post-intervention surveys , respectively ) require conservative interpretation .


The main limitations of this study are as follows : ( @ ) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant , and ( @ ) the low survey response rates .


This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms , other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse .


Complementary legislative action may be required to more effectively reduce alcohol harms .


The aim of this study was to compare pure coagulation and blended current in the resection of large colorectal sessile polyps ( SPs ) .


Between January @ and June @ , @ patients ( @ men , @ women ; median age @ y ; range , @ to @ y ) with large colorectal SPs ( diameter @ cm ) were randomized in @:@ ratio to undergo treatment by the `` lift and cut '' piecemeal resection technique .


A total of @ blended current subjects ( group A ) were well matched to @ pure coagulation current subjects ( group B ) , with a median lesion size of @ cm ( group A , @ vs. group B , @ cm ; P = @ ) , respectively .


The rate of complications , the factors that predict complications , and the recurrence of adenoma were analyzed .


Complete macroscopic resection was achieved in @ patients ( @ % ) of group A and in @ patients ( @ % ) of group B ( P = @ ) .


Argon plasma coagulation at resection 's margins was performed in @ patients ( @ % ) of group A and in @ patients ( @ % ) of group B ( P = @ ) .


Eight patients ( @ % ) -LSB- group A , n = @ patients ( @ % ) vs. group B , n = @ patients ( @ % ) ; P = @ -RSB- developed immediate ( @ ) or delayed ( @ ) bleeding .


Four patients with bleeding were under treatment with selective serotonin reuptake inhibitors .


All bleedings were successfully treated conservatively or with endoclipping and heater probe application .


Perforation occurred in @ patient of each group and was managed by clips closure and antibiotics and right hemicolectomy , respectively .


Postpolypectomy syndrome was observed in @ patients ( @ % ) of group A and @ patients ( @ % ) of group B ( P = @ ) .


In @ patients , the histopathologic analysis of resected SPs revealed invasive carcinoma , and surgical resection was performed in @ patient .


Two patients refused operation .


Among the patients who underwent follow-up surveillance colonoscopy , a total recurrence rate of @ % of adenomas with no difference was observed between the @ groups -LSB- group A , n = @ patients ( @ % ) vs. group B , n = @ patients ( @ % ) ; P = @ -RSB- .


Recurrence of adenoma was observed in @ patients ( @ % ) without and in @ patients ( @ % ) with argon plasma coagulation treatment .


No difference was found in the rate of complications between the @ types of current used in the resection of large colorectal SPs .


However , an influence of selective serotonin reuptake inhibitors on postpolypectomy bleeding was observed , which deserves further investigation .


Oxidized phospholipids on apolipoprotein B-@ ( OxPL-apoB ) is a biomarker of increased risk for major adverse cardiovascular events ( MACE ) in community cohorts , but its role in patients with stable coronary heart disease ( CHD ) is unknown .


This study sought to examine the relationship between these oxidative biomarkers and cardiovascular outcomes in patients with established CHD .


In a random sample from the TNT ( Treating to New Targets ) trial , OxPL-apoB levels were measured in @,@ patients at randomization ( after an @-week run-in period taking atorvastatin @ mg ) and @ year after being randomized to atorvastatin @ or @ mg .


We examined the association between baseline levels of OxPL-apoB and MACE , defined as death from CHD , nonfatal myocardial infarction , resuscitation after cardiac arrest , and fatal/nonfatal stroke , as well as the effect of statin therapy on OxPL-apoB levels and MACE .


Patients with events ( n = @ ) had higher randomization levels of OxPL-apoB than those without events ( p = @ ) .


For the overall cohort , randomization levels of OxPL-apoB predicted subsequent MACE ( hazard ratio -LSB- HR -RSB- : @ ; @ % confidence interval : @ to @ ; p = @ ) per doubling and tertile @ versus tertile @ ( hazard ratio : @ ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) after multivariate adjustment for age , sex , body mass index , among others , and treatment assignment .


In the atorvastatin @-mg group , tertile @ was associated with a higher risk of MACE compared to the first tertile ( HR : @ ; @ % CI : @ to @ ; p = @ ) but this was not significant in the atorvastatin @-mg group ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


Elevated OxPL-apoB levels predict secondary MACE in patients with stable CHD , a risk that is mitigated by atorvastatin @ mg .


( A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels -LSB- TNT -RSB- ; NCT@ ) .


Paraoxonase @ ( PON@ ) , an enzyme associated with high-density lipoprotein ( HDL-PON@ ) , is reported to have antioxidant and cardioprotective properties .


The aim of the present study was to investigate the effects of anthocyanins on the HDL-PON@ activity and cholesterol efflux capacity in hypercholesterolemic subjects .


A total of @ hypercholesterolemic subjects were given @ mg of anthocyanins twice daily or placebo ( n = @ of each group ) for @ weeks in a double-blind , randomized , placebo-controlled trial .


Participants and investigators were masked to treatment allocation .


Anthocyanin consumption significantly increased HDL cholesterol and decreased low - density lipoprotein cholesterol concentrations compared with placebo ( P < @ and P < @ , respectively ) .


Anthocyanin supplementation also increased the activity of HDL-PON@ compared with placebo ( P < @ ) .


Furthermore , cholesterol efflux capacity was increased more in the anthocyanin group ( @ % increase ) than in the placebo group ( @ % increase ) ( P < @ ) .


The negative correlations established between HDL-PON@ activity and the levels of lipid hydroperoxides associated with HDL confirm the relationship between PON@ activity and lipid peroxidation of lipoproteins .


Furthermore , a strong positive correlation was noted between increased HDL-PON@ activity and improved cholesterol efflux capacity both before and after adjustment for HDL cholesterol and apolipoprotein AI in anthocyanin-treated subjects ( both P < @ ) .


Inhibition of HDL-PON@ activity strongly prevented the antioxidant ability of HDL and attenuated the cholesterol efflux capacity of subjects from anthocyanin group .


Our observations suggest that the alterations of PON@ activity by anthocyanin observed in hypercholesterolemic HDL reflect a shift to an improvement of cholesterol efflux capacity of HDL and may provide a link between anthocyanin and cardioprotective effects .


To determine the effects of steady-state concentrations of the selective S@P@ receptor modulator ponesimod on the pharmacokinetics ( PK ) of a single dose of a combined oral contraceptive , containing @mg norethisterone ( NET ) and @g ethinyl estradiol ( EE ) and to investigate the effects on heart rate at different ponesimod doses within an up-titration regimen prior to co-administration of the contraceptive .


Twenty-two healthy women ( age : @-@years ) received twice a single oral dose of the combined oral contraceptive , alone or in combination with multiple doses of @mg ponesimod attained by an up-titration regimen .


Heart rate ( HR ) effects were assessed on the first day of each up-titration level .


PK parameters of NET and EE were determined by non-compartmental analysis .


Geometric mean ratios ( ponesimod and contraceptive / contraceptive alone ) of Cmax and AUC@-@ of NET were @ ( @ % CI : @ , @ ) and @ ( @ % CI : @ , @ ) , respectively .


Geometric mean ratios of Cmax and AUC@-@ of EE were @ ( @ % CI : @ , @ ) and @ ( @ % CI : @ , @ ) , respectively .


The maximum mean HR reduction after the first dose of @mg ponesimod was @ bpm ( SD@ @ ) at @ h post-dose .


On Day @ ( first dose of @mg ) and Day @ ( first dose of @mg ) the maximum mean HR reduction was @ bpm ( SD@ @ ) and @ ( SD@ @ ) , respectively , at @ h post-dose compared to baseline .


No clinically relevant PK interactions between ponesimod and the combined oral contraceptive were observed , therefore , efficacy of hormonal contraceptives is not expected to be affected by concomitant administration of ponesimod .


The up-titration regimen showed that HR reductions are diminished upon repeated ponesimod administration .


Patellofemoral pain ( PFP ) is the most common injury in running and jumping athletes .


Randomized controlled trials suggest that incorporating hip and core strengthening ( HIP ) with knee-focused rehabilitation ( KNEE ) improves PFP outcomes .


However , no randomized controlled trials have , to our knowledge , directly compared HIP and KNEE programs .


To compare PFP pain , function , hip - and knee-muscle strength , and core endurance between KNEE and HIP protocols after @ weeks of rehabilitation .


We hypothesized greater improvements in ( @ ) pain and function , ( @ ) hip strength and core endurance for patients with PFP involved in the HIP protocol , and ( @ ) knee strength for patients involved in the KNEE protocol .


Randomized controlled clinical trial .


Four clinical research laboratories in Calgary , Alberta ; Chicago , Illinois ; Milwaukee , Wisconsin ; and Augusta , Georgia .


Of @ patients with PFP screened , @ ( @ % ) met the inclusion criteria ( @ men -LSB- @ % -RSB- , @ women -LSB- @ % -RSB- , age = @ @ years , height = @ @ cm , weight = @ @ kg ) .


Patients with PFP were randomly assigned to a @-week KNEE or HIP protocol .


Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures , which were conducted weekly .


Secondary variables were muscle strength and core endurance measured at baseline and at @ weeks .


Compared with baseline , both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols ( P < @ ) , but the visual analog scale scores for those in the HIP protocol were reduced @ week earlier than in the KNEE group .


Both groups increased in strength ( P < @ ) , but those in the HIP protocol gained more in hip-abductor ( P = @ ) and - extensor ( P = @ ) strength and posterior core endurance ( P = @ ) compared with the KNEE group .


Both the HIP and KNEE rehabilitation protocols produced improvements in PFP , function , and strength over @ weeks .


Although outcomes were similar , the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol .


To compare visual outcome and manual handling of additional multifocal sulcus-fixated intraocular lenses ( IOLs ) of different materials and lens concepts .


Visual outcomes after implantation of a monofocal IOL in the capsular bag followed by implantation of a sulcus-fixated multifocal IOL ( MIOL ) in patients with cataract were assessed .


Patients were randomly assigned to receive either the refractive Sulcoflex @F ( Rayner Surgical GmbH , Bamberg , Germany ) ( @ eyes ) or the diffractive MS @ PB Diff ( Dr. Schmidt Intraocularlinsen GmbH , St. Augustin , Germany ) ( @ eyes ) additional MIOL .


Three months postoperatively , visual acuity at far , intermediate , and near distance and contrast sensitivity under different conditions were evaluated .


Patients with binocular implantation were asked to rate their subjective quality of vision .


No complications occurred during or after surgery .


No significant differences in uncorrected and corrected distance visual acuity at all distances were found between groups .


All eyes achieved uncorrected visual acuity of @ logMAR ( @/@ Snellen ) or better at all distances .


Contrast sensitivity was significantly better in the diffractive MS @ PB Diff group than in the refractive Sulcoflex @F group under all conditions .


The refractive Sulcoflex @F group experienced more photic phenomena ( @ % ) than the diffractive MS @ PB Diff group ( @ % ) , but the disturbances were scored as mild to moderate in most cases ( @ % / @ % ) .


The unfolding procedure of the acrylic Sulcoflex @F IOL was smoother and more controllable than that of the silicone MS @ PB Diff IOL .


Both additional MIOLs performed well in terms of far , intermediate , and near vision and enabled patients to handle almost all areas of activity without glasses .


The aim of this study was to evaluate the effect of an intensive physical therapy protocol in patients who contract ` intensive care unit-acquired weakness ' ( ICUAW ) , in terms of muscle strength , breathing and functional indices .


This was a prospective , single-blinded study in a general hospital intensive care unit ( ICU ) .


Patients who required mechanical ventilation longer than @h and who were expected to remain mechanically ventilated for at least another @h were randomly divided into two intervention groups : group I ( n = @ ) - the routine care group , received physical therapy according to our daily custom protocol ; and group II ( n = @ ) - the intensive treatment group , were treated by the same protocol twice a day .


The main outcome measures included the Medical Research Council ( MRC ) physical strength examination , maximal inspiratory pressure ( MIP ) , hand grip dynamometer and sitting balance test .


Significant strength improvement from first ( T@ ) to second ( T@ ) measurements was demonstrated for variables MIP and MRC physical strength examination in favor of the intensive treatment group ( P < @ ) .


The intensive treatment group also required shorter intensive care length of stay than the routine care group ( P = @ ) .


It is possible that an intensive therapy protocol may facilitate the initial recovery process in patients who suffer from ICUAW .


In patients with a first unprovoked venous thromboembolism ( VTE ) the risk of recurrent VTE remains high after anticoagulant treatment is discontinued .


The Aspirin for the Prevention of Recurrent Venous Thromboembolism ( the Warfarin and Aspirin -LSB- WARFASA -RSB- ) and the Aspirin to Prevent Recurrent Venous Thromboembolism ( ASPIRE ) trials showed that aspirin reduces this risk , but they were not individually powered to detect treatment effects for particular outcomes or subgroups .


An individual patient data analysis of these trials was planned , before their results were known , to assess the effect of aspirin versus placebo on recurrent VTE , major vascular events ( recurrent VTE , myocardial infarction , stroke , and cardiovascular disease death ) and bleeding , overall and within predefined subgroups .


The primary analysis , for VTE , was by intention to treat using time-to-event data .


Of @ patients , @ had recurrent VTE over @ months ' median follow-up .


Aspirin reduced recurrent VTE ( @ % / yr versus @ % / yr ; hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ) , including both deep-vein thrombosis ( HR , @ ; @ % CI , @-@ @ ; P = @ ) and pulmonary embolism ( HR , @ ; @ % CI , @-@ @ ; P = @ ) .


Aspirin reduced major vascular events ( @ % / yr versus @ % / yr ; HR , @ ; @ % CI , @-@ @ ; P = @ ) .


The major bleeding rate was low ( @ % / yr for placebo and @ % / yr for aspirin ) .


After adjustment for treatment adherence , recurrent VTE was reduced by @ % ( HR , @ ; @ % CI , @-@ @ ; P = @ ) .


Prespecified subgroup analyses indicate similar relative , but larger absolute , risk reductions in men and older patients .


Aspirin after anticoagulant treatment reduces the overall risk of recurrence by more than a third in a broad cross-section of patients with a first unprovoked VTE , without significantly increasing the risk of bleeding .


Patient-reported outcome ( PRO ) measures are increasingly being used in clinical practice to inform individual patient management , but evidence is needed on which PROs are best suited for clinical use .


This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures : European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core @ ( QLQ-C@ ) , Supportive Care Needs Survey-Short Form ( SCNS-SF@ ) , or six domains from the Patient-Reported Outcomes Measurement Information System ( PROMIS ) .


Patients completed the PRO measures before clinic visits , and the results were provided to both the patient and clinician .


At treatment completion , patients and clinicians completed brief feedback forms on the intervention 's usefulness and value .


Exit interviews were conducted with patients ( at end of treatment ) and clinicians ( at end of study ) .


The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items .


Of @ eligible patients invited to participate , @ ( @ % ) enrolled ( median age @ years , @ % white , @ % prostate ) .


Of the @ patients ( @ % ) who completed at least one feedback form item , participants in the QLQ-C@ study arm were most likely to strongly agree/agree to all items ( @ % ) followed by PROMIS ( @ % ) and SCNS-SF@ ( @ % ; P = @ ) .


Of the @ participants ( @ % ) who completed all feedback form items , the results were similar : @ % for the QLQ-C@ , @ % for PROMIS , and @ % for SCNS-SF@ ( P = @ ) .


Clinicians did not prefer one questionnaire over the others .


These results suggest that , when using PROs in clinical practice for patient management , the measure matters in terms of usefulness to patients .


To assess the efficacy and tolerability of add-on pregabalin controlled-release formulation ( PGB-CR ) ( doses of @ or @ mg/day ) in patients with partial-onset seizures ( POS ) .


This was a randomized , double-blind ( DB ) , parallel-group study of PGB-CR once-daily as adjunctive treatment in adults with treatment-resistant partial seizures .


After an @-week baseline period , eligible patients were randomized ( @:@:@ ) to placebo , PGB-CR @ mg , or PGB-CR @ mg for @ weeks , including a @-week dose escalation .


Primary endpoint was the loge - transformed @-day seizure rate for all POS with observable component during the full @-week double-blind treatment phase .


Secondary endpoints included the @ % responder rate and percent change from baseline in @-day POS rate .


Three hundred twenty-three patients were randomized and received treatment ; placebo ( n = @ ) , PGB-CR @ mg ( n = @ ) , PGB-CR @ mg ( n = @ ) ; and @ ( @ % ) completed the trial .


The primary efficacy analysis result , expressed as percent reduction from placebo , was @ % and @ % for PGB-CR @ mg and PGB-CR @ mg , respectively , and was not statistically significant ( p = @ , @ ) .


The proportion of @ % responders was similar for placebo ( @ % ) and @ mg PGB-CR ( @ % ) and nominally higher for @ mg PGB-CR ( @ % , p = @ compared to placebo ) .


The LS mean estimates of the percent change from baseline for placebo ( -@ % ) was nominally smaller than @ mg PGB-CR ( -@ % , p = @ ) and @ mg PGB-CR ( -@ % , p = @ ) ; however , the median percent changes from baseline were not as well differentiated ( placebo , -@ % ; @ mg PGB-CR , -@ % ; @ mg PGB-CR -@ % ) .


Rates of adverse events ( AEs ) were low for placebo and study drug ; the most frequent reported AEs were dizziness , somnolence , and fatigue , consistent with the immediate-release formulation .


Results from this trial did not demonstrate that PGB-CR is effective in reducing seizure frequency below that of placebo .


Both doses of PGB-CR were shown to be safe and well-tolerated .


Administration of supplemental oxygen in the perioperative period is controversial , as it may increase long-term mortality .


Our aim was to assess the association between @ % oxygen and occurrence of subsequent cancer in patients undergoing abdominal surgery in a post hoc analysis of the PROXI trial .


The @ patients in the PROXI trial underwent elective or emergency laparotomy between @ and @ with randomization to either @ % or @ % oxygen during and for @ h after surgery .


We retrieved follow-up status regarding vital status , new cancer diagnoses , and new histological cancer specimens .


Data were analysed using the Cox proportional hazards model .


Follow-up was complete in @ patients ( @ % ) after a median of @ yr .


The primary outcome of new cancer diagnosis or new malignant histological specimen occurred in @ of @ patients ( @ % ) in the @ % oxygen group vs @ of @ patients ( @ % ) assigned to @ % oxygen ; hazards ratio @ -LSB- @ % confidence interval ( CI ) @ , @ -RSB- , P = @ .


Cancer-free survival was significantly shorter in the @ % oxygen group ; hazards ratio @ ( @ % CI @ , @ ) , P = @ , as was the time between surgery and new cancer , median @ vs. @ days in the @ % oxygen group .


In patients with localized disease , non-significant differences in cancer and cancer-free survival were found with hazard ratios of @ and @ , respectively .


Although new cancers occurred at similar rate , the cancer-free survival was significantly shorter in the @ % oxygen group , but this did not appear to explain the excess mortality in the @ % oxygen group .


Target-controlled infusion ( TCI ) is used to maintain the desired concentration of a hypnotic drug in the plasma and brain .


However , pharmacodynamic variability can cause problems with maintaining the adequate level of anaesthesia .


The bispectral index ( BIS ) is one of only a few parameters that allow an assessment of the depth of anaesthesia .


In the present study , we attempted to determine the optimal dosages of drugs used for total intravenous anaesthesia with TCI based on BIS-guided monitoring of depth of anaesthesia .


The study was conducted in @ ASA I patients undergoing elective surgery due to lumbar discopathy .


The participants were divided into two groups of @ individuals .


The patients were premedicated with @ mg oral midazolam .


Group I was the control group ; group II received BIS monitoring .


Anaesthesia was induced with TCI propofol ( @ mg mL ) , fentanyl ( @ mg kg ) and vecuronium ( @ mg kg ) and maintained with TCI propofol , continuous infusion of vecuronium ( @ mg kg h ) and fractionated doses of fentanyl .


ECG , HR , MAP , SaO , ETCO , and the degree of neuromuscular blockade were monitored , specifically at the following time points : T - before induction , T - after induction , T - after intubation , T - after positioning of the patient , T-T - every @ min during surgery , T - on completion of surgery , T - before extubation , T - after extubation .


The study groups were comparable in terms of age , body weight , duration of anaesthesia and recovery time .


The haemodynamic parameters , such as HR and MAP , did not differ significantly between the groups .


In both groups , changes in the mean MAP values were observed between T and T , T and T , T and T as well as Tand T.


The total dose of fentanyl and the doses of propofol were lower in the group that received BIS monitoring .


BIS monitoring reduces the doses of opioids and hypnotics used during total intravenous anaesthesia by TCI .


A modified quadrant method was developed for description of femoral tunnel aperture positions on the sagittal plane after double-bundle anterior cruciate ligament ( ACL ) reconstruction , which can be measured by using two-view radiographs .


The purpose of the study is to provide a new measurement method and to evaluate the reproducibility and accuracy of the method .


Forty-one patients who had undergone a double-bundle ACL reconstruction were investigated .


Two-view plain radiographs , a @-degree-flexion posterior-anterior standing ( Rosenberg ) and a lateral view , were taken at @year postoperatively , and the femoral tunnel positions were measured .


Intra - and inter-observer reproducibility was calculated by means of intra-class correlation coefficient ( ICC ) .


Also , the accuracy of the method was evaluated by comparing the measurement from three-dimensional computed tomography ( @D-CT ) .


Intra-observer reproducibility was excellent ( ICC > @ ) .


Inter-observer reproducibility of antero-medial ( AM ) tunnel position was almost perfect ( ICC > @ ) and that of postero-lateral ( PL ) tunnel was substantial ( ICC > @ ) .


The accuracy of the method was assessed by comparing the measurement from @D-CT and was found to be almost perfect ( ICC > @ ) .


With the modified quadrant method , the average height of AM and PL tunnels were @ and @ % , respectively , and the depth of AM and PL tunnels were @ and @ % , respectively .


A modified quadrant method was found to have acceptable reproducibility and accuracy .


The method is useful for describing the femoral tunnel aperture positions in ACL reconstruction because of its easiness and simplicity .


By using this method , it is possible to analyse the femoral tunnel position even in the cases without CT analysis .


Platelet endothelial aggregation receptor @ ( PEAR@ ) is a membrane protein involved in platelet contact-induced activation and sustained platelet aggregation .


Experimental studies identified PEAR@ , as a candidate gene that may be linked to the blood-pressure driven kidney injury in salt-sensitive Dahl rats .


In a family-based European population study ( mean age @ years ; @ % women ) , we searched for association of changes in blood pressure or incidence of hypertension with genetic variation in PEAR@ .


Among @ randomly recruited people , genotyped for PEAR@ , we measured blood pressure at baseline and follow-up .


Median follow-up was @ years .


While accounting for family clusters and blood pressure at baseline and with adjustments applied for sex , age , body mass index , smoking and drinking , total cholesterol , and antihypertensive drug treatment , all associations of systolic and diastolic blood pressure changes with nine single nucleotide polymorphisms ( SNPs ) in PEAR@ were all non-significant ( p @ ) .


With similar adjustments , the incidence of hypertension ( @ cases among @ participants were normotensive at baseline -LSB- @ % -RSB- ) was not related to the SNPs in PEAR@ ( hazard ratios @ ; p @ ) .


Our study suggests that PEAR@ is not a hypertension susceptibility gene in humans .


The statistical analysis of nasal provocation tests is very complex .


We compared the conventional analysis with the maximally selected test statistics and the hierarchical ordered logistic model .


We re-analyzed data from a trial with @ patients suffering from grass pollen allergy .


The patients had been randomized to receive either intralymphatic immunotherapy ( ILIT ) or subcutaneous immunotherapy ( SCIT ) .


The conventional analysis indicated that the logarithmized ratio between the pre - and the post-treatment threshold concentration was significantly lower for ILIT than for SCIT .


The maximally selected test statistics was used to test different threshold symptom scores that would imply positive clinical symptoms at the given allergen concentration .


A threshold score of @ maximised the difference in improvement between the ILIT and the SCIT groups .


The hierarchical ordered logistic model does not take threshold allergen concentrations as the basis for analysis , but the single scores measured at each concentration .


This approach simultaneously considers the treatment effect ( ILIT versus SCIT ) , the time effect ( pre - versus post-treatment ) , and the dose effect ( different allergen concentrations ) .


The hierarchical ordered logistic model revealed that the clinical improvement was greater after ILIT than after SCIT .


As the choice of method can affect the outcome , guidelines for analysis are highly needed .


Endothelial function can be assessed by acetylcholine ( ACh ) iontophoresis with single current application .


The effect of inter-electrode distance as well as electrical cutaneous resistance ( ECR ) on ACh dependent vasodilation has never been studied using single current application .


The aims of this study are ( i ) to compare ACh-peak and ECR measured at different inter-electrode distances , ( ii ) to assess the relationship between ACh-peak and ECR , ( iii ) and to study the reproducibility of the ECR values .


Fourteen healthy subjects were included .


Using laser speckle contrast imaging , ACh-iontophoreses ( @ mA , @s ) were performed on the forearm at a @-day interval with an inter-electrode distance set at @ cm .


Two other inter-electrode distances were also evaluated : @ cm and @ cm .


ECR was measured during each ACh-iontophoresis as well as the ACh-peak .


No statistical difference was found between the ACh-peak values obtained at @ cm , @ cm and @ cm .


ECRs were also not statistically different .


An inverse relationship ( r = -@ ) was found between the ACh-peak and ECR ( p < @ ) .


The coefficient of variation of the inter-day reproducibility of the ECR values was @ % -LSB- @ % -@ % -RSB- with an intra-class-correlation coefficient of @ -LSB- @-@ @ -RSB- .


Inter-electrode distance ranging from @ cm to @ cm changes neither the ACh-peak value nor the ECR value .


ECR impacts ACh-peak values .


To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress .


Randomized controlled trial .


Four ICUs at an academic tertiary care center .


Immediate family members of patients suspected to have suffered brain death .


Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone .


All randomized subjects were administered a validated `` understanding brain death '' survey before and after the intervention .


Subjects were assessed for psychological well-being between @ and @ days after the intervention .


Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire .


Brain death understanding , Impact of Event Scale , and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests .


Analyses were adjusted for within family correlation .


Fifty-eight family members of @ patients undergoing brain death evaluation were enrolled : @ family members were present for @ brain death evaluations and @ family members were absent for six brain death evaluations .


Baseline understanding scores were similar between groups ( median @ -LSB- presence group -RSB- vs @ -LSB- control -RSB- , p = @ ) .


Scores increased by a median of @ ( interquartile range , @-@ ) if present versus @ ( interquartile range , @-@ ) if absent ( p < @ ) .


Sixty-six percent of those in the intervention group achieved perfect postintervention `` understanding '' scores , compared with @ % of subjects who were not present ( p = @ ) .


Median Impact of Event Scale and General Health Questionnaire scores were similar between groups at follow-up ( Impact of Event Scale : present = @ , absent = @ , p = @ ; General Health Questionnaire : present = @ , absent = @ , p = @ ) .


Family presence during brain death evaluation improves understanding of brain death with no apparent adverse impact on psychological well-being .


Family presence during brain death evaluation is feasible and safe .


This study was designed to assess the effects of calcium and vitamin D supplementation on the metabolic status of pregnant women with gestational diabetes mellitus ( GDM ) .


This randomised placebo-controlled trial was performed at maternity clinics affiliated to Kashan University of Medical Sciences , Kashan , Iran .


Participants were @ women with GDM at @-@ weeks ' gestation ( @ to @ years of age ) .


Subjects were randomly assigned to receive calcium plus vitamin D supplements or placebo .


All study participants were blinded to group assignment .


Individuals in the calcium-vitamin D group ( n = @ ) received @,@ mg calcium per day and a @,@ U vitamin D@ pearl twice during the study ( at study baseline and on day @ of the intervention ) , and those in the placebo group ( n = @ ) received two placebos at the mentioned times .


Fasting blood samples were taken at study baseline and after @ weeks of intervention .


The study was completed by @ participants ( calcium-vitamin D n = @ , placebo n = @ ) .


However , as the analysis was based on an intention-to-treat approach , all @ women with GDM ( @ in each group ) were included in the final analysis .


After the administration of calcium plus vitamin D supplements , we observed a significant reduction in fasting plasma glucose ( -@ @ vs +@ @ mmol/l , p < @ ) , serum insulin levels ( -@ @ vs +@ @ pmol/l , p = @ ) and HOMA-IR ( -@ @ vs +@ @ , p = @ ) and a significant increase in QUICKI ( +@ @ vs -@ @ , p = @ ) compared with placebo .


In addition , a significant reduction in serum LDL-cholesterol ( -@ @ vs +@ @ mmol/l , p = @ ) and total cholesterol : HDL-cholesterol ratio ( -@ @ vs +@ @ , p = @ ) and a significant elevation in HDL-cholesterol levels ( +@ @ vs -@ @ mmol/l , p = @ ) was seen after intervention in the calcium-vitamin D group compared with placebo .


In addition , calcium plus vitamin D supplementation resulted in a significant increase in GSH ( +@ @ vs -@ @ mol/l , p = @ ) and prevented a rise in MDA levels ( +@ @ vs +@ @ mol/l , p = @ ) compared with placebo .


Calcium plus vitamin D supplementation in women with GDM had beneficial effects on their metabolic profile .


Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success .


Text messaging holds promise as a viable self-monitoring modality , particularly among racial/ethnic minority populations .


This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women .


Fifty obese women were randomized to either a @-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals ( eg , @,@ steps per day , no sugary drinks ) along with brief feedback and tips ( n = @ ) or to an education control arm ( n = @ ) .


Weight was objectively measured at baseline and at @ months .


Adherence was defined as the proportion of text messages received in response to self-monitoring prompts .


The average daily text messaging adherence rate was @ % ( SD @ ) with @ % ( @/@ ) texting self-monitored behavioral goals @ or more days per week .


Approximately @ % ( @/@ ) strongly agreed that daily texting was easy and helpful and @ % ( @/@ ) felt the frequency of texting was appropriate .


At @ months , the intervention arm lost a mean of @ kg ( SD @ ) , and the control arm gained a mean of @ kg ( SD @ ; mean difference -@ kg , @ % CI -@ to @ ; P = @ ) .


There was a trend toward greater text messaging adherence being associated with greater percent weight loss ( r = -@ ; P = @ ) , but this did not reach statistical significance .


There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence .


Given the increasing penetration of mobile devices , text messaging may be a useful self-monitoring tool for weight control , particularly among populations most in need of intervention .


Mannitol and hypertonic saline ( HS ) are routinely used during craniotomy .


Both increase myocardial preload and reduce afterload , and may improve cardiac output .


It is not currently known whether this results in an improvement in the global myocardial function .


Thus , the aim of this study was to compare the effects of a single equiosmolar bolus of @ % mannitol ( @ mL/kg ) or @ % HS ( @ mL/kg ) on the global myocardial function by tissue Doppler-derived myocardial performance index ( TD-MPI ) in patients undergoing craniotomy .


Fifty adult patients were included and randomized to receive either mannitol or @ % HS .


Transesophageal echocardiography was performed in all patients .


Early ( E ) and late ( A ) peak mitral inflow velocity , early diastolic mitral annular velocity ( E prime ) , isovolumetric relaxation time ( IVRT ) , ejection time ( ET ) , and isovolumetric contraction time ( IVCT ) were recorded at baseline and at @ , @ , @ , and @ minutes after administration of the hyperosmolar solutions .


TD-MPI was calculated as IVRT+IVCT / ET .


There were no significant differences in the TD-MPI ( HS vs. mannitol : @ vs. @ -LSB- baseline -RSB- , @ vs. @ -LSB- @ min -RSB- , @ vs. @ -LSB- @ min -RSB- , @ vs. @ -LSB- @ min -RSB- , @ vs. @ -LSB- @ min -RSB- ) , E/A ratio , IVCT , and E/E ' either within or between the @ groups at any time point .


IVRT was prolonged in HS group as compared with baseline at @ , @ , and @ minutes postinfusion .


ET was decreased in both the groups at @ minutes postinfusion .


Neither of these altered the TD-MPI .


Equiosmolar administration of @ % mannitol and @ % HS did not show any difference in global myocardial performance as measured by TD MPI .


Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities , but limited research has assessed their impact in multiethnic populations .


We examined whether an interactive multimedia computer program ( IMCP ) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample .


We undertook a randomized controlled trial , comparing an IMCP tailored to colorectal cancer screening self-efficacy , knowledge , barriers , readiness , test preference , and experiences with a nontailored informational program , both delivered before office visits .


The primary outcome was record-documented colorectal cancer screening during a @-month follow-up period .


Secondary outcomes included postvisit sociopsychological factor status and discussion , as well as clinician recommendation of screening during office visits .


We enrolled @,@ patients stratified by ethnicity and language ( @ % non-Hispanic , @ % Hispanic/English , @ % Hispanic/Spanish ) from @ offices around @ centers ( Sacramento , California ; Rochester and the Bronx , New York ; Denver , Colorado ; and San Antonio , Texas ) .


Adjusting for ethnicity/language , study center , and the previsit value of the dependent variable , compared with control patients , the IMCP led to significantly greater colorectal cancer screening knowledge , self-efficacy , readiness , test preference specificity , discussion , and recommendation .


During the followup period , @ ( @ % ) IMCP and @ ( @ % ) control patients received screening ( adjusted difference = @ percentage points , @ % CI -@ to @ ) .


IMCP effects did not differ significantly by ethnicity/language .


Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample , despite enhancing sociopsychological factors and visit behaviors associated with screening .


The utility of sociopsychological tailoring in addressing screening disparities remains uncertain .


Postoperative emergency agitation ( EA ) is a common problem often observed in children undergoing general anesthesia .


The purpose of this study was to evaluate whether a bolus of intraoperative low-dose ketamine followed by dexmedetomidine i.v. could reduce the incidence of EA in children undergoing adenotonsillectomy following sevoflurane-based anesthesia .


A total of @ children undergoing adenotonsillectomy , aged @-@ years , were randomly allocated to receive either low-doseketamine @ mg/kg followed by dexmedetomidine @ g/kg i.v. ( KETODEX , n = @ ) or volume-matched normal saline ( Control , n = @ ) , about @ min before the end of surgery .


Anesthesia was induced and maintained with sevoflurane .


Postoperative pain and EA were assessed with objective pain score ( OPS ) and the Pediatric Anesthesia Emergence Delirium scale ( PAED ) , respectively .


EA was defined as a PAED@ points .


Recovery profile and postoperative complications were recorded .


The incidence and severity of EA was lower in KETODEX group than controls ( @ % vs. @ % ) and ( @ % vs. @ % ) , respectively ( P < @ ) .


The frequency of fentanyl rescue was lower in KETODEX group than in controls ( @ vs. @ % , P < @ ) .


Heart rate during extubation was significantly higher in the control group compared with children who received KETODEX ( P < @ ) .


The incidence of postoperative pain was significantly less in the KETODEX group ( @ % vs. @ % , P < @ ) .


Times to interaction and extubation were significantly longer in the KETODEX group ( P < @ ) .


KETODEX reduces the incidence and severity of EA in children undergoing adenotonsillectomy following sevoflurane-based anesthesia and provided smooth extubation .


The purpose of this study was to evaluate if ultrasound derived measures of diaphragm thickening , rather than diaphragm motion , can be used to predict extubation success or failure .


Sixty-three mechanically ventilated patients were prospectively recruited .


Diaphragm thickness ( tdi ) was measured in the zone of apposition of the diaphragm to the rib cage using a @-@ MHz ultrasound transducer .


The percent change in tdi between end-expiration and end-inspiration ( tdi % ) was calculated during either spontaneous breathing ( SB ) or pressure support ( PS ) weaning trials .


A successful extubation was defined as SB for > @ h following endotracheal tube removal .


Of the @ subjects studied , @ patients were weaned with SB and @ were weaned with PS .


The combined sensitivity and specificity of tdi % @ % for extubation success was @ % and @ % , respectively .


The positive predictive value and negative predictive value were @ % and @ % , respectively .


The area under the receiver operating characteristic curve was @ for tdi % .


Ultrasound measures of diaphragm thickening in the zone of apposition may be useful to predict extubation success or failure during SB or PS trials .


The Spine Patient Outcomes Research Trial ( SPORT ) is a highly referenced clinical trial that randomized patients with lumbar pathology to receive surgery or continued conservative treatment .


The purpose of this study was to compare the SPORT lumbar disc herniation cohort and an analogous cohort from the National Surgical Quality Improvement Program ( NSQIP ) database .


This is a retrospective cohort study comparing a national database population to a randomized clinical trial .


Elective lumbar discectomies from NSQIP between @ and @ were used .


Demographics were compared between the randomized SPORT cohorts ( surgical and nonoperative ) and NSQIP .


Perioperative factors and complications were then compared between SPORT discectomy patients and NSQIP .


Using current procedural terminology and International Classification of Diseases , ninth revision codes , all elective lumbar discectomies from NSQIP between @ and @ were identified .


Where possible based on the published data and variables available in each cohort , the two populations were compared .


A total of @,@ NSQIP discectomy patients were compared with the randomized SPORT surgical and nonoperative cohorts .


Demographic comparisons showed that NSQIP patients were older ( average age @ years -LSB- meanstandard deviation -RSB- vs. @ and @ years , respectively -LSB- p < @ -RSB- ) and had higher body mass index ( @ kg/m ( @ ) vs. @ and @ kg/m ( @ ) , respectively -LSB- p < @ -RSB- ) .


No statistical differences existed for gender or race .


Smoking status was not different between the SPORT nonoperative group and NSQIP but was higher in NSQIP compared with SPORT surgical patients ( p = @ by @ % ) .


Comparisons of perioperative factors and complications between the SPORT surgical cohort and NSQIP showed no statistical difference in average operative time , length of stay , deep wound infections , wound dehiscence , total wound complications , or blood transfusions .


Spine Patient Outcomes Research Trial superficial wound infection rates were higher than NSQIP ( p = @ by @ % ) .


As expected , SPORT @-year reoperation rates were higher than NSQIP @-day rates ( @ % vs. @ % , p < @ ) .


Spine Patient Outcomes Research Trial lumbar disc herniation results are similar to those from a large national patient sample .


Even statistically significant differences would be considered clinically similar .


These findings support the generalizability of the SPORT lumbar disc herniation results .


Transverse sinus stenosis is an imaging finding very highly associated with elevated intracranial pressure ( ICP ) .


Patients with the Chiari I malformation may potentially have elevated ICP due to impairment of CSF flow at the foramen magnum .


This study evaluated whether patients with Chiari I malformation have transverse sinus stenosis and other imaging findings indicative of elevated ICP .


Thirty patients with Chiari I malformation treated surgically and @ control subjects were identified retrospectively .


All control subjects and all patients with Chiari I malformation ( preoperatively ) underwent standardized contrast-enhanced brain MRI including a contrast-enhanced @D T@-weighted sequence from which curved reformats of the transverse sinuses were generated .


Two different readers blinded to the diagnosis then independently evaluated these curved reformats for severity of transverse sinus stenosis .


Orbital and skull-base findings previously described in association with elevated ICP were also evaluated .


Frequency of MRI findings between the two groups was compared .


Patients with Chiari I malformation had significantly greater frequency of unilateral or bilateral transverse sinus stenosis than did control subjects ( p < @ ) .


There was complete interreader agreement on presence or absence of transverse sinus stenosis by patient ( = @ -LSB- @ % CI , @-@ @ -RSB- ) .


Logistic regression analysis controlling for age , sex , and body mass index found that transverse sinus stenosis significantly predicted Chiari I malformation versus control status ( odds ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; p = @ ) but that no other features were significantly associated with the Chiari I malformation .


Patients with Chiari I malformation who had transverse sinus stenosis had significantly greater pituitary flattening than did those without transverse sinus stenosis ( p = @ ) .


Patients with Chiari I malformation have higher likelihood of transverse sinus stenosis , which may reflect associated elevated ICP .


Cardiovascular diseases have become the leading cause of death from chronic diseases in the world .


Main risk factors include hypercholesterolemia , which is caused in most cases by a high saturated fat diet .


Plant stanol esters partly block cholesterol absorption in the digestive tract and thereby reduce total cholesterol and low-density lipoprotein ( LDL ) cholesterol serum levels .


Based on epidemiological data , a @ percent reduction of LDL cholesterol leads to a @ percent decrease in the coronary heart disease risk throughout life .


The aim of this study was to evaluate the efficacy of yogurt drink with added plant stanol esters ( Benecol yogurt drink ) in higher doses than the typically used ( @g/d stanols ) , in lowering blood lipids in moderately hypercholesterolemic subjects .


A randomized double-blind crossover , placebo-controlled study in moderately hypercholesterolemic subjects ( n = @ ) aged between @ and @years old .


Yogurt drink with added plant stanols ( @g ) as esters ( Benecol , Colanta ) consumption compared to regular yogurt drink caused a statistically significant decrease in total cholesterol and low density lipoprotein cholesterol by @ % and @ % .


During the two periods and compared to controls , high-density lipoprotein cholesterol and triglycerides were not significantly different .


Yogurt drink with an active ingredient in Benecol , plant stanol esters , reduced total cholesterol and LDL cholesterol in moderately hypercholesterolemic subjects .


Traditional Chinese medical treatment of primary Sjgren 's syndrome has advantages over Western medicine in terms of fewer side effects and improved patient conditions .


This study was a multicenter , randomized , double-blind , placebo-controlled clinical trial of the efficacy and safety of ShengJinRunZaoYangXue granules for the treatment of primary Sjgren 's syndrome , including the symptoms of dry mouth and dry eye .


We undertook a @-week , double-blind , randomized trial involving @ patients with primary Sjgren 's syndrome at five centers in East China .


A computer-generated randomization schedule assigned patients at a @:@ ratio to receive either ShengJinRunZaoYangXue granules or placebo once daily .


Patients and investigators were blinded to treatment allocation .


The primary endpoints were the salivary flow rate , Schirmer test results , and sugar test results .


Intention-to-treat and per-protocol analyses were performed .


All @ patients were randomly allocated to either the treatment group ( n = @ , ShengJinRunZaoYangXue granules ) or placebo group ( n = @ ) and were included in the intention-to-treat analysis .


After program violation and loss to follow-up , a total of @ patients were included in the per-protocol analysis .


At six week , intention-to-treat and per-protocol analyses of the left-eye Schirmer I test results showed an improved difference of @ mm/@ min ( @ % CI : @ to @ mm/@ min ) and @ mm/@ min ( @ % CI : @ to @ mm/@ min ) , respectively , and those of the right-eye Schirmer I test results showed an improved difference of @ mm/@ min ( @ % CI : @ to @ mm/@ min ) and @ mm/@ min ( @ % CI : -@ to @ mm/@ min ) , respectively .


There was no significant difference between the two groups before treatment .


After treatment , the between-group and within-group before-and-after paired comparison results were statistically significant ( P < @ ) .


Intention-to-treat and per-protocol analyses showed an improved salivary flow rate by @ ml/@ min ( @ % CI : -@ to @ ml/@ min ) and @ ml/@ min ( @ % CI : -@ to @ ml/@ min ) , respectively , but the differences were not significant .


Intention-to-treat and per-protocol analyses showed that the sugar test results were improved by @ minutes ( @ % CI : @ to @ minutes ) and @ minutes ( @ % CI : @ to @ minutes ) , respectively , but the differences were not significant .


For the secondary endpoint , intention-to-treat and per-protocol analyses showed significant improvement in the integrated evaluation of treated patients with dry eye and dry mouth after six weeks of treatment .


The incidence of adverse events was @ % in the treatment group and @ % in the placebo group .


Most ( @ % ) adverse events were mild to moderate in the two groups , and only two cases of serious adverse events occurred in the treatment group ; both were caused by autoimmune liver disease .


Six-week treatment with ShengJinRun ZaoYangXue granules for primary Sjgren 's syndrome in this large-scale study improved the symptoms of dry mouth , dry eyes , and low tear flow rate with minimal adverse events .


Endovascular aortic aneurysm repair ( EVAR ) may result in deterioration of renal function .


Mannitol has renovascular and antioxidant properties that could prove beneficial in this respect .


A randomized prospective study .


Attikon University Hospital , single institution .


Eighty-six patients undergoing elective EVAR under regional anesthesia .


Patients received hydration alone ( controls ) or hydration plus mannitol ( @ g/kg ) .


Creatinine , serum cystatin-C , urine neutrophil-gelatinase-associated lipocalin ( NGAL ) , albuminuria and serum urea were measured @ hours and @ hours after the procedure ( baseline NGAL was measured in @ randomly selected patients ) .


Serum creatinine also was measured at the followup of the patients .


Serum creatinine and cystatin-C were lower in the mannitol group at @ hours postoperatively ( creatinine , mannitol -LSB- n = @ -RSB- ; @ -LSB- CI@ % : @-@ @ -RSB- v controls -LSB- n = @ -RSB- ; @ -LSB- CI@ % : @-@ @ -RSB- ) , but not at @ hours ( creatinine , mannitol -LSB- n = @ -RSB- ; @ -LSB- CI@ % : @-@ @ -RSB- v controls -LSB- n = @ -RSB- ; @ -LSB- CI@ % @-@ @ -RSB- ) .


Urine NGAL increased substantially at @ hours without differences between groups .


At followup ( controls : @ months ; mannitol : @ months ) , there were no differences between creatinine or creatinine clearance ( creatinine : controls -LSB- n = @ -RSB- ; @ -LSB- CI@ % @-@ @ -RSB- v mannitol -LSB- n = @ -RSB- ; @ -LSB- CI@ % : @-@ @ -RSB- ) .


The overall changes of creatinine and creatinine clearance with time were significant in controls but not in the mannitol group .


The classification according to the RIFLE criteria yielded @ patients at risk for renal injury and @ with renal injury in the control group and @ patients at risk with no patients with injury in the mannitol group , but the difference of renal dysfunction between the @ groups was not statistically significant .


Mannitol plus hydration during EVAR provides a small but significant benefit for renal function .


Future preventive protocols aiming at greater restoration of renal function after EVAR could include mannitol as a useful component .


The aim of this study was to compare the effects of concomitant administration of alcohol and bilastine versus alcohol alone on the central nervous system .


Twenty-four healthy young volunteers of both sexes participated in a randomized , double-blind , double-dummy , crossover , and positive-controlled and placebo-controlled clinical trials .


At @-week intervals , subjects received six different treatments : ( i ) placebo ; ( ii ) alcohol @ g/kg alone ( ALC ) ; ( iii ) ALC in combination with : bilastine @mg ( B@ + A ) ; ( iv ) bilastine @mg ( B@ + A ) ; ( v ) cetirizine @mg ( CET+A ) ; and ( vi ) hydroxyzine @mg ( HYD+A ) .


Psychomotor performance tests ( fine motor , finger tapping , nystagmus , critical flicker-fusion frequency , temporal estimation , 'd @ ' cancellation , and simple reaction time ) and subjective self-reports ( drunkenness , drowsiness , mental slowness , clumsiness , anger , attentiveness , competence , happiness , hostility , interest , and extroversion ) were carried out at baseline and multiple points thereafter .


All active treatments induced a significant psychomotor impairment .


The greatest and most lasting impairment was observed with HYD+A followed by B@ + A and CET+A .


In contrast , objective measures showed less impairment with B@ + A and ALC , both with a similar magnitude .


Self-reports showed a subjective perception of performance impairment in all active treatments .


Concomitant administration of bilastine ( at therapeutic dose ) and alcohol does not produce greater central nervous system depressant effects than ACL alone .


Laparoscopic sleeve gastrectomy ( LSG ) is a surgical technique that treats morbid obesity .


Consecutive patients with morbid obesity treated by LSG at our department were evaluated .


Patients enrolled in the study were randomized into group I ( LSG begins the division @ cm from the pylorus ) and group II ( LSG begins the division @ cm from the pylorus ) .


The primary outcome measure was the percent of excess weight loss ( % EWL ) ; secondary outcomes included postoperative morbidity and mortality and improvement of comorbidity .


One hundred five patients ( @ ( @ % ) were females ) were randomized into two groups of ( GI ) @ patients and ( GII ) @ patients .


In group I , the mean % EWL was @ , @ and @ ; however , in group II , the mean % EWL was @ , @ and @ at @ , @ , and @ months , respectively ( P = @ , @ , @ ) .


There was weight regain after @ years in five patients in group II and only one patient in group I ( P = @ ) .


There was no significant difference between both group as regards gastric leakage , vomiting or GER .


There was significant improvement in comorbidity after LSG in both groups , but no significant difference between them .


Hospital mortality occurred in group II in one case as a result of gastric leakage .


LSG is a safe and effective procedure with good short-term outcome .


Increasing the size of the resected antrum is associated with better weight loss without increasing the rate of complications significantly .


Topical @ % @-fluorouracil ( @-FU ) is known to cause toxicity , such as erythema , pain , and crusting/erosions .


We sought to develop a scale to measure this toxicity and test the scale for reliability .


A scale was developed involving four parameters : erythema severity , percentage of face involved in erythema , crusting/erosions severity , and percentage of face involved in crusting/erosions .


Thirteen raters graded @ sets of photographs from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention ( VAKCC ) Trial using these parameters .


Intraclass correlation overall for @ raters was @ ( @ % CI @-@ @ ) .


There was no statistically significant trend in reliability by level of training in dermatology .


This scale is a reliable method of evaluating the severity of toxicity from topical @-fluorouracil and can be used by dermatologists and nondermatologists alike .


Preterm rupture of membranes ( PROM ) is associated with an increased risk of preterm birth and neonatal morbidity .


Prophylactic @-hydroxyprogesterone caproate ( @OHP-C ) reduces the risk of preterm birth in some women who are at risk for preterm birth .


We sought to test whether @OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes .


This is a multicenter , double-blind , placebo-controlled , randomized clinical trial .


The study included singleton pregnancies with gestational ages from @ ( @/@ ) to @ ( @/@ ) weeks at enrollment , documented PROM , and no contraindication to expectant management .


Consenting women were assigned randomly to receive weekly intramuscular injections of @OHP-C ( @ mg ) or placebo .


The primary outcome was continuation of pregnancy until a favorable gestational age , which was defined as either @ ( @/@ ) weeks of gestation or documentation of fetal lung maturity at @ ( @/@ ) to @ ( @/@ ) weeks of gestation .


The @ prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome .


The planned sample size was @ total women .


From October @ to April @ , @ women were enrolled ; @ women were allocated randomly to @OHP-C , and @ were allocated randomly to placebo .


The trial was stopped when results of a planned interim analysis suggested that continuation was futile .


The primary outcome was achieved in @ % of the @OHP-C group and @ % of the placebo group ( P = @ ) .


There was no significant between-group difference in the prespecified secondary outcomes , randomization-to-delivery interval ( @ @ vs @ @ days , respectively ; P = @ ) or composite adverse perinatal outcome ( @ % vs @ % , respectively ; P = @ ) .


No significant differences were found in other outcomes , which included rates of chorioamnionitis , postpartum endometritis , cesarean delivery , individual components of the composite outcome , or prolonged neonatal length of stay .


Compared with placebo , weekly @OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial .


The aim of the study was to examine the long-term effect of commonly used whole soy foods ( soy flour ) and purified daidzein ( one major isoflavone and the precursor of equol ) on renal function among prehypertensive postmenopausal women who are also equol producers , a population most likely to benefit from soy intervention .


This was a @-month double-blind , randomized , placebo-controlled trial .


Two hundred seventy eligible Chinese women were randomized to either one of the three treatments : @ g soy flour ( whole soy group ) , @ g low-fat milk powder + @ mg daidzein ( daidzein group ) or @ g low-fat milk powder ( placebo group ) daily each for @ months .


Fasting blood and @-h urine samples were collected at the beginning and end of trial .


Serum creatinine , cystatin C , urea , angiotensin-converting enzyme , minerals and @-h urinary creatinine and minerals were analyzed .


Estimated glomerular filtration rate ( eGFR ) was calculated with the Cockcroft-Gault and the Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) equations .


Two hundred fifty-three subjects completed the study according to the protocol .


Urinary isoflavones indicated good compliance of participants .


No significant changes were observed in most of renal parameters , however , there was a less decrease in eGFRcockcroft in @-month change ( p = @ ) and % change ( p = @ ) with whole soy intake relative to milk placebo .


Subgroup analysis among women with lowered renal function suggested whole soy consumption tended to improve markers of renal function relative to control .


Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function .


Future trials in subjects with more declined renal function are necessary .


Measure of arterial stiffness could be affected by the presence of abdominal aortic aneurysm ( AAA ) and especially an intraluminal thrombus ( ILT ) .


We , therefore , sought to study this possible connection by measuring pulse wave velocity ( PWV ) and pulse wave analysis ( PWA ) including augmentation index adjusted to heart rate @ ( Aix@ ) in patients with AAA ILT .


PWV and PWA were measured in male patients with AAA from an ongoing Danish AAA screening trial .


Information on blood pressure , medications , BMI and smoking status was obtained at inclusion .


In total , @ patients were included .


Mean age was @ years .


Mean AAA size was @ mm .


Fifty-six of the patients had an intraluminal thrombus , and patients with AAA and ILT had a significantly higher Aix@ than patients with AAA but without ILT ( Mean = @ @ SEM vs. @ @ , p = @ ) , a difference that was also significant when adjusting for AAA size , blood pressure and age .


There was no difference in PWV between the groups .


Haemodynamic properties of the aorta are affected by the presence of ILT in patients with AAA that is not explained by aortic size .


Alternatively , these findings could be explained by associations between ILT and properties of the left ventricle .


The aim of this study was to evaluate the safety and efficacy of the GORE ( ) Septal Occluder ( GSO ) at @ - , @ - , and @-month follow-up in patients with a clinical indication for patent foramen ovale ( PFO ) closure .


Limited data are available regarding the safety and efficacy of the GSO for PFO closure .


Sixty consecutive patients with an embolic event , migraine , or risk of decompression sickness were enrolled .


Transesophageal or transthoracic echocardiography and clinical follow-up were performed at @ , @ and @ months after implantation .


All patients received @ mg aspirin and @ mg clopidogrel for @ months .


Procedures were technically successful in @ % ( @/@ ) .


In one case , the anterior interatrial septal rim proved too short to allow safe GSO implantation and , instead , a different occluder was implanted .


One patient developed transient neurological symptoms during the procedure without evidence for a stroke by magnetic resonance imaging .


At @-month follow-up , the closure rate was @ % ( @/@ ) .


The complete closure rate after @ year was @ % ( @/@ ) .


Stroke , thrombus formation and atrial fibrillation ( AF ) / flutter occurred in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients , respectively .


PFO closure with the GSO is accompanied by a high technical success rate and closure rates similar to other currently used devices .


The incidence of AF was higher than reported with most other devices .


This may be a chance finding but warrants further investigation in larger trials .


Patients with malignant pleural mesothelioma ( MPM ) may develop painful ` procedure tract metastasis ' ( PTM ) at the site of previous pleural interventions .


Prophylactic radiotherapy has been used to minimise this complication ; however , three small randomised trials have shown conflicting results regarding its effectiveness .


The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial ( SMART Trial ) is a suitably powered , multicentre , randomised controlled trial , designed to evaluate the efficacy of prophylactic radiotherapy within @days of pleural instrumentation in preventing the development of PTM in MPM .


@ patients with a histocytologically proven diagnosis of MPM , who have undergone a large bore pleural intervention ( thoracic surgery , large bore chest drain , indwelling pleural catheter or local anaesthetic thoracoscopy ) in the previous @days , will be recruited from UK hospitals .


Patients will be randomised ( @:@ ) to receive immediate radiotherapy ( @Gy in @ fractions over @ working days within @days of the pleural intervention ) or deferred radiotherapy ( @Gy in @ fractions over @ working days given if a PTM develops ) .


Patients will be followed up for @months .


The primary outcome measure is the rate of PTM until death or @months ( whichever is sooner ) , as defined by the presence of a clinically palpable nodule of at least @cm diameter felt within @cm of the margins of the procedure site as confirmed by two assessors .


Secondary outcome measures include chest pain , quality of life , analgaesic requirements , healthcare utilisation and safety ( including radiotherapy toxicity ) .


Preoperative therapy with chemotherapy and the HER@-targeted monoclonal antibody trastuzumab is valuable for patients with large or locally advanced HER@-positive ( HER@ + ) breast cancers but traditional methods of measuring HER@ expression do not accurately stratify patients for likelihood of response .


Quantitative immunofluorescent approaches have the potential to provide a mathematically continuous measure of HER@ .


Here we seek to determine whether quantitative measurement of HER@ or phospho-HER@ correlates with likelihood of response to trastuzumab - containing neoadjuvant therapy .


We evaluated core biopsy samples from @ HER@ + breast cancer patients enrolled in a preoperative clinical trial using trastuzumab , nab-paclitaxel and carboplatin combination therapy ( BrUOG BR-@B ( NCT@ ) ) .


Tumor core biopsies were taken before initiation of treatment and @-@ days after patients received `` run-in '' doses of either single agent trastuzumab or nab-paclitaxel .


The AQUA method of quantitative immunofluorescence was used for analysis of in situ protein expression .


Patients then received @weeks of treatment , followed by surgery to assess pathologic response to the neoadjuvant regimen .


A HER@ score of @ by AQUA analysis has been shown to be equivalent to HER@ @ + by immunohistochemical staining in previous studies .


Of @ evaluable patients , @ cases who achieved a pathologic complete response ( pathCR ) with neoadjuvant treatment had a mean HER@ level of @ compared with @ in the patients without pathCR ( p = @ ) .


Measurement of phospho-HER@ showed no difference in pathCR vs non-pathCR groups .


In @ patients who had HER@ levels repeated after a single treatment with trastuzumab there was no evidence of a reduction in the HER@ or phospho-HER@ levels following that exposure .


High levels of HER@ are associated with achievement of a pathCR in the preoperative setting , while levels of Phospho-HER@ were not predictive of response .


This data suggests that accurate measurement of HER@ may help determine the likelihood of response in the pre-surgical setting .


Further validation in larger cohorts is required , but this pilot data shows the feasibility of this approach .


Exercise related leg pain ( ERLP ) is a common lower limb overuse injury characterised by pain located between the knee and ankle that occurs during activity .


The high incidence of the condition , subsequent interference with participation in physical activity and substantial recovery time , highlights a need for effective interventions .


Whilst many interventions have been described for the management of ERLP , currently there is a lack of high quality evidence for an effective intervention for the condition .


A single-blinded randomised controlled clinical trial will be conducted in a community setting .


Forty-five female volunteers aged between @ and @years with a history of insidious onset of pain located between the knee and ankle of at least one month duration that is aggravated by weight bearing activities will be recruited for the study .


Suitable participants will be randomly allocated to one of three treatment groups for the @week intervention period : ( i ) exercise only , ( ii ) rigid anti-pronation tape and exercise , ( iii ) elastic anti-pronation tape and exercise .


Outcomes will be measured at baseline , @ , @ and @ weeks using primary outcome measures of usual and worst pain visual analogue scale and global perceived improvement .


Secondary outcome measures will include Foot and Ankle Ability Measure , Patient Specific Functional Scale and amount of activity in the previous week .


In addition , participants will be contacted by phone to obtain primary and secondary outcome measures at @ , @ , @ and @weeks .


This article describes a single-blinded randomised controlled clinical trial that will utilise high quality methodologies in accordance with CONSORT guidelines .


The results of this study will contribute to the limited knowledge regarding effective interventions for the management of ERLP .


To assess efficacy and safety of dexmedetomidine for treatment of delirium in cardiac surgery .


We performed an open , prospective comparative study in @ patients , who received surgery on the heart or major vessels under general anaesthesia .


In the early postoperative period , all patients suffered from delirium .


All patients were divided into two groups .


The patients in group-I ( @ patients ) received dexmedetomidine ( @-@ @ mcg/kg / hour ) , @ of them received dexmedetomidine only and @ received a combination of dexmedetomidine with haloperidol and midazolam .


Patients in group-@ received haloperidol @ mg @ times a day intramuscularly and @ mg/kg intravenously separately and in combination with benzodiazepines ( midazolam , relanium ) .


All patients received analgesia with ketoprofen @ mg each @ hours and trimeperidin @ mg intramuscularly .


In @ % of all patients the symptoms of delirium occurred on the @st or @nd day after surgery .


A hyperactive type of delirium dominated ( > @ % ) .


The average lasting time of delirium was @ hours in group-I and @ hours in group-@ ( p = @ ) .


Spontaneous breathing occurred in @ patients ( @ % ) out of group-I and in @ patients ( @ % ) out of group-@ ( p = @ ) .


The duration of stay in the ICU was @ days in group-I and @ days in group-@ ( p = @ ) .


Dexmedetomidine provided an average target level of sedation better according to RASS-scale ( p = @ ) .


@ patients ( @ % ) of group-I and @ patients ( @ % ) of group-@ received opioids ( p = @ ) .


Bradycardia as a side effect predominated in group-I ( p = @ ) .


Respiratory depression predominated in group-I ( p = @ ) .


Dexmedetomidine provides an average target level of sedation , decreases duration of delirium and duration of stay in the ICU .


Dexmedetomidine does not cause depression of respiration which allows keeping a verbal contact with patients and improving a diagnostics of pain syndrome .


The most common side effect of the dexmedetomidine use is a dose-depending bradycardia .