The postprandial TG and NO response were significantly different between healthy control ( HC ) and hypertriglyceridemia group ( HTG ) after both meals ( P < @ ) .


After both meals maximal change and iAUC for TG was all higher in HTG group than HC group , the difference was significant after low n-@ meal but not after high n-@ meal .


The concentration of glucose , insulin , IL-@ , TNF and ET-@ at each time point was higher and NO was lower in HTG group , but the maximal change and iAUC had no significant difference except for iAUC of insulin , IL-@ and diAUC of NO after low n-@ meal .


The ratio of n-@ and n-@ maybe do not acutely influence the postprandial metabolism , inflammatory response and endothelial function , but the low n-@ meal can strengthen the difference between HTG and HC group .


Severe asthma is a major public health issue throughout the world .


Increased bronchial smooth muscle ( BSM ) mass , a characteristic feature of airway remodeling in severe asthma , is associated with resistance to high-intensity treatment and poor prognosis .


In vitro , the Ca ( @ + ) - channel blocker gallopamil decreased the proliferation of BSM cells from patients with severe asthma .


We conducted a double-blind , randomized , placebo-controlled study to evaluate the effect of gallopamil on airway remodeling in patients with severe asthma .


Subjects received either gallopamil ( n = @ ) or placebo ( n = @ ) for @ year and were monitored for an additional @-month period .


Airway remodeling was analyzed at baseline and after treatment phase using both fiberoptic bronchoscopy and computed tomography scan .


The primary end point was the BSM area .


Secondary end points included normalized BSM thickness and frequency of asthma exacerbations .


BSM area was reduced in the gallopamil group ( baseline vs. end of treatment ) but was unchanged in the placebo group .


Between-group differences in BSM area were not significantly different in gallopamil versus placebo groups .


By contrast , between-group differences in normalized BSM thickness were significantly different between the two groups .


The mean number of exacerbations per month was not different during the treatment phase in gallopamil versus placebo group but was significantly lower in patients previously treated with gallopamil during the follow-up period .


There were no differences between the groups with respect to overall side effects .


Gallopamil treatment for @ months reduces BSM remodeling and prevents the occurrence of asthma exacerbations .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


Previous studies have demonstrated variable patterns of longitudinal septal deformation in patients with left ventricular ( LV ) dysfunction and left bundle branch block .


This prospective single center study was designed to assess the relationship between septal deformation patterns obtained by two-dimensional speckle-tracking echocardiography and response to cardiac resynchronization therapy ( CRT ) .


One hundred one patients with New York Heart Association class II to IV heart failure , LV ejection fractions @ % , and left bundle branch block underwent echocardiography before CRT .


Longitudinal two-dimensional speckle-tracking strain analysis in the apical four-chamber view identified three patterns : double-peaked systolic shortening ( pattern @ ) , early pre-ejection shortening peak followed by prominent systolic stretch ( pattern @ ) , and pseudonormal shortening with a late systolic shortening peak and less pronounced end-systolic stretch ( pattern @ ) .


CRT response was defined as a relative reduction in LV end-systolic volume of @ % at @-month follow-up .


CRT super-response was defined as an absolute LV ejection fraction of @ % associated with a relative reduction in LV end-systolic volume of @ % and an improvement in New York Heart Association functional class .


Cardiac death or hospitalization for heart failure during follow-up was systematically investigated .


Ninety-two percent of patients with pattern @ or @ were responders to CRT compared with @ % with pattern @ ( P < @ ) .


Thirty-six percent of patients with pattern @ were super-responders compared with @ % of those with pattern @ and @ % of those with pattern @ ( P = @ ) .


The improvement in LV volumes , LV ejection fraction , and global longitudinal strain after CRT was better in patients with pattern @ or @ compared with those with pattern @ ( P < @ for all ) .


Eighteen-month outcomes were excellent in patients with pattern @ or @ , with event-free survival of @ @ % compared with @ @ % in patients with pattern @ ( P = @ ) .


Septal deformation strain pattern @ or @ is highly predictive of CRT response .


Further studies are needed to identify predictors of `` nonresponse '' in patients with a pattern @ .


The purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control .


This examiner-blind , randomized study used a crossover design .


Sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes ( Spinbrush Truly Radiant Deep Clean -LSB- TRDC -RSB- or Spinbrush Truly Radiant Extra Whitening -LSB- TREW -RSB- , Church & Dwight Co. , Inc. , Princeton , NJ , USA ) or an ADA standard manual toothbrush ( MT ; American Dental Association , Chicago , IL , USA ) according to one of three computer-generated sequences .


Following instruction in the use of their assigned toothbrush , subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period .


At the end of this period , the subjects returned to the study site after refraining from oral hygiene for @-@ hours , and from eating , drinking , and smoking for four hours .


Plaque was scored using the Rustogi Modification of the Navy Plaque Index .


Subjects brushed under supervision with their assigned toothbrush for two minutes , and plaque was rescored .


They were then given one of the alternate toothbrushes according to their assigned sequence , and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes .


Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores ( p < @ ) , with respective whole mouth reductions of @ % , @ % , and @ % for MT , TRDC , and TREW .


Between-group analyses showed that TRDC and TREW were each significantly more effective ( p < @ ) than MT , as each showed at least twice as much of a reduction in whole mouth scores .


Both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined , with the greatest differences at interpoximal sites and sites presenting access difficulty , such as those in the lingual posterior region .


Additionally , TRDC produced a statistically significant @ % greater reduction than TREW ( p = @ ) in whole mouth plaque scores , and statistically significantly greater reductions in two of the subsets evaluated .


Both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque .


While the finding that the TRDC was significantly more effective than the TREW in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance , longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes .


This study 's aims were to detect and quantify bacterial DNA in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence ( UUI ) without clinical evidence of urinary tract infection ( UTI ) and to determine if the presence of bacterial DNA in baseline urine relates to either baseline urinary symptoms or UTI risk after urinary tract instrumentation .


Women without clinical evidence of baseline UTI were randomized to cystoscopic onabotulinum toxin A injection and oral placebo medication versus cystoscopic placebo injection and active oral medication .


Bacterial DNA in participants ' catheterized urine was measured by quantitative polymerase chain reaction ( qPCR ) .


Bacterial DNA was detected in the urine of @ % of participants ( @ out of @ ) .


In these @ qPCR-positive participants , baseline daily UUI episodes were greater than in the @ qPCR-negative participants ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , p = @ ) .


Neither symptom severity by questionnaire nor treatment outcome was associated with qPCR status or with qPCR level in qPCR-positive subjects .


In contrast , the presence of urinary bacterial DNA was associated with UTI risk : only @ % of the qPCR-positive women developed a UTI post-treatment , while @ % of the qPCR-negative women did so .


The median qPCR level for qPCR-positive samples did not differ significantly by UTI status ( UTI @ ( @ ) vs no UTI @ ( @ ) copies/mL , p = @ ) .


These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of post-treatment UTI .


The increased intraocular pressure ( IOP ) - which decreases perfusion pressure on the optic nerve - increases by prone positioning ( @ ) .


The aim of our study was to compare the effect of head rotation @ laterally in prone position on the increase in IOP of upper placed and lower placed eyes in patients undergoing percutaneous nephrolithotomy ( PCNL ) .


Forty-five patients were randomly divided into @ Groups .


IOP of the patients were recorded bilaterally in supine position before the operation had started .


Patients were turned to prone position .


The head was placed on a prone headrest without external direct compression to both eyes .


Patients in Group I were kept in strictly neutral prone position where as patients in Group II were placed prone with their heads rotated @ laterally to the right side .


At the end of the operation , patients were turned to supine position and their IOP was measured immediately .


There was no difference related to demographics , duration of surgery , blood loss and fluid input data .


IOP values after surgery in prone position increased significantly compared to preoperative values in both groups ( p < @ ) .


After surgery in prone position IOP values of the upper positioned eyes in Group II were significantly lower than Group I and lower positioned eyes in Group II ( p < @ ) .


prone positioning increases IOP .


In patients with prone position with a head rotation of @ laterally , IOP in the upper positioned eye was significantly lower .


It is estimated that about @,@ inhabitants experience an out-of-hospital cardiac arrest ( OHCA ) every year in Europe .


Survival in out-of-hospital cardiac arrest is relatively low , generally between five per cent and @ % .


Being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions .


Passive leg raise ( PLR ) during cardiopulmonary resuscitation ( CPR ) has been found to improve cardiac preload and blood flow during chest compressions .


The aim of our study is to evaluate whether early PLR during CPR also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest ( OHCA ) .


A prospective , randomized , controlled trial in which all patients ( @years ) receiving out-of hospital CPR are randomized by envelope to be treated with either PLR or in the flat position .


The ambulance crew use a special folding stool which allows the legs to be elevated about @ degrees .


Primary end-point : survival to one month .


Secondary end-point : survival to hospital admission to one month and to one year with acceptable cerebral performance classification ( CPC ) @-@ .


PLR is a simple and fast maneuver .


We believe that the greatest benefit with PLR is when performed early in the process , during the first minutes of CPR and before the first defibrillation .


To reach power this study need @ patients , we hope that this method article will encourage other sites to contact us and take part in our study .


To investigate the possibility of influencing adolescents ' caries incidence , knowledge and attitudes to oral health and tobacco through a school-based oral health intervention programme .


Four schools in a county in Sweden were randomised to one intervention and one control group .


At the intervention schools , two dental hygienists worked @ h every week for two years .


Health education and preventive measures , such as fluoride varnish treatments every @ months , were performed .


The control group had no intervention .


The study included a total of @ participants aged @-@ years .


Outcome variables of the study were @ ) caries incidence assessed on bite-wing radiographs and @ ) knowledge and attitudes measured through questionnaires .


The intervention programme impacted on the incidence of enamel caries , while no effect on dentin caries could be seen .


Data from the questionnaires showed that the adolescents considered their teeth as important .


Adolescents in the intervention group had better knowledge about oral health and oral hygiene compared to the control group after the two years , but no impact on attitudes toward tobacco could be seen .


A majority of the adolescents were positive to the education about oral health and tobacco and they believed that the dental hygienists would help them improve their oral health .


Although the effects of the intervention as regards to caries incidence , knowledge and attitudes were limited , the presence of dental hygienists in school was appreciated by the adolescents and seemed to increase their interest in their oral health .


Traumatic brain injury ( TBI ) is a major cause of death and disability worldwide .


Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI .


We conducted a double-blind , multicenter clinical trial in which patients with severe , moderate-to-severe , or moderate acute TBI ( Glasgow Coma Scale score of @ to @ , on a scale from @ to @ , with lower scores indicating a lower level of consciousness ) were randomly assigned to intravenous progesterone or placebo , with the study treatment initiated within @ hours after injury and administered for a total of @ hours .


Efficacy was defined as an increase of @ percentage points in the proportion of patients with a favorable outcome , as determined with the use of the stratified dichotomy of the Extended Glasgow Outcome Scale score at @ months after injury .


Secondary outcomes included mortality and the Disability Rating Scale score .


A total of @ of the planned sample of @ patients underwent randomization before the trial was stopped for futility with respect to the primary outcome .


The study groups were similar with regard to baseline characteristics ; the median age of the patients was @ years , @ % were men , @ % were black , and the mean Injury Severity Score was @ ( on a scale from @ to @ , with higher scores indicating greater severity ) .


The most frequent mechanism of injury was a motor vehicle accident .


There was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome ( relative benefit of progesterone , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


Phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group ( relative risk , @ ; CI , @ to @ ) .


There were no significant differences in the other prespecified safety outcomes .


This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI .


( Funded by the National Institute of Neurological Disorders and Stroke and others ; PROTECT III ClinicalTrials.gov number , NCT@ . )


Family members and caregivers play a significant supporting role in the rehabilitation process after stroke , a role that may increase with the growing trend of providing stroke rehabilitation in the individual 's own home after discharge from the hospital .


To explore the impact of family involvement in exercise delivery after stroke from the perspective of the individual with stroke and his or her family member .


A qualitative research design was used in which in-depth semi-structured interviews were carried out with participants who had taken part in an @-week family-mediated exercise program ( FAME ) .


A phenomenological theoretical framework and a grounded theory methodology were used to inform the data analysis .


Fifteen individuals with acute stroke and @ designated `` family '' members participated in the study after completion of an @-week , individually tailored , family-mediated exercise intervention .


An overarching concept of patient-centeredness emerged after data analysis , which detailed the extent to which individuals with stroke and their families felt that their rehabilitation was enhanced by the active role of their families .


Four key themes that expanded the concept of patient-centeredness were identified : personalized nature of the reported benefits , therapeutic value of the program , family involvement , and caregiver commitment to program .


This research serves to increase our understanding of the role of family members in the rehabilitation process after stroke , particularly in relation to exercise delivery , from the perspective of the individuals with stroke and their family members .


Scaling and root planing ( SRP ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited .


Consequently , various adjunctive therapies have been investigated to improve clinical outcome .


This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months .


An examiner-blind clinical trial was conducted among @ subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application ( Perio Tray ) of @ % hydrogen peroxide gel ( Perio Gel ) for a period of three months , then extended to six months .


Following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase .


SRP was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( PPD ) and bleeding index ( BI ) , were conducted at baseline and after two , five , @ , and @ weeks of peroxide gel applications .


Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval .


A total of @ test and @ control subjects completed the original three-month trial , of whom @ test and @ control subjects finished the three-month extension .


After two weeks of peroxide gel use prior to SRP , mean PPD for the test group significantly decreased from baseline by @ mm and mean BI significantly dropped by @ ; clinical parameters for the control group were unchanged .


Two weeks following SRP , mean PPD significantly decreased from baseline by @ mm for the test group and @ mm for the control ; mean BI significantly dropped by @ for the test group and @ for the control .


Ten weeks following SRP , mean PPD decreases were @ mm for the test group and @ mm for the control , and mean BI reductions were @ for the test group and @ for the control .


For subjects who completed the three-month extension ( i.e. , @ weeks post-SRP ) , mean PPD decreases were @ mm for the test group and @ mm for the control , and mean BI reductions were @ for the test group and @ for the control .


Analysis of deeper pockets ( i.e. , > @ mm at baseline ) showed the same relationship for PPD , but with larger differences between groups .


For example , after two weeks of peroxide gel use prior to SRP , mean PPD decreased by @ mm for the test group compared to @ mm for the control .


Two weeks after SRP , mean PPD decreased from baseline by @ mm for the test group and @ mm for the control , and @ weeks after SRP by @ mm for the test group and @ mm for the control .


After the extension ( i.e. , @ weeks post-SRP ) , mean PPD changed from baseline by @ mm for the test group and @ mm for the control .


With the exception of BI at @ weeks post-SRP , all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons .


When compared with SRP alone , clinical improvements in PPD ( e.g. , -@ mm for pockets > @ mm at baseline ) were maintained for up to six months after SRP with adjunctive use of @ % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .


To evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth .


This was a secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial .


Women with a history of pregnancy loss ( original stratum : one loss less than @ weeks of gestation during the previous year ; expanded stratum : one or two losses with no restrictions on timing or gestational age of the losses ) were randomized to either daily low-dose aspirin ( @ mg , n = @ ) and folic acid or folic acid alone ( placebo ; n = @ ) .


Preterm birth was compared between groups using intent-to-treat analysis .


Preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( relative risk -LSB- RR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) ; spontaneous preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( RR @ , @ % CI @-@ @ ) ; medically indicated preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( RR @ , @ % CI @-@ @ ) .


After restriction to confirmed pregnancies using inverse probability weighting , preterm birth rates were @ % and @ % ( RR @ , @ % CI @-@ @ ) and spontaneous preterm birth rates were @ % and @ % ( RR @ , @ % CI @-@ @ ) .


In confirmed pregnancies in the original stratum , preterm birth occurred in @ % and @ % of the low-dose aspirin and placebo groups , respectively ( RR @ , @ % CI @-@ @ ) .


Preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth .


Although the study was underpowered for this secondary analysis , numeric trends in favor of benefit , particularly in the women with a recent , single early pregnancy loss , warrant further investigation .


Cardiovascular disease is the leading cause of death worldwide .


Higher oxidative stress may contribute to the pathogenesis of coronary artery disease ( CAD ) .


The purpose of this study was to investigate the effect of L-carnitine ( LC , @mg/d ) on the markers of oxidative stress and antioxidant enzymes activities in CAD patients .


We enrolled @ CAD patients in the study .


The CAD patients were identified by cardiac catheterization as having at least @ % stenosis of one major coronary artery .


The subjects were randomly assigned to the placebo ( n = @ ) and LC ( n = @ ) groups .


The intervention was administered for @weeks .


The levels of serum LC , plasma malondialdehyde ( MDA ) , and erythrocyte antioxidant enzymes activities -LSB- catalase ( CAT ) , superoxide dismutase ( SOD ) , glutathione peroxidase ( GPx ) -RSB- were measured before and after intervention .


Thirty-nine subjects completed the study ( placebo , n = @ ; LC , n = @ ) .


After @weeks of LC supplementation , the level of MDA was significantly reduced ( @ to @ mol/L , P = @ ) and the level of LC ( @ to @ mol/L , P = @ ) and antioxidant enzymes activities -LSB- CAT ( @ to @ U/mg of protein , P = @ ) , SOD ( @ to @ U/mg of protein , P < @ ) , and GPx ( @ to @ U/mg of protein , P = @ ) -RSB- were significantly increased .


The level of LC was significantly positively correlated with the antioxidant enzymes activities ( CAT , = @ , P = @ ; SOD , = @ , P < @ ) .


LC supplementation at a dose of @mg/d was associated with a significant reduction in oxidative stress and an increase in antioxidant enzymes activities in CAD patients .


CAD patients might benefit from using LC supplements to increase their anti-oxidation capacity .


Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( HNSCC ) progressing after first-line platinum regimens have a poor prognosis and few treatment options .


Afatinib , an irreversible ERBB family blocker , has shown efficacy in a phase @ study in this setting .


We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy .


In this open-label , phase @ , randomised controlled trial conducted in @ centres in @ countries , we enrolled patients aged @ years or older with histologically or cytologically confirmed HNSCC that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an Eastern Cooperative Oncology Group ( ECOG ) performance status of @ or @ .


Previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with EGFR-targeted antibody therapy ( but not EGFR-targeted tyrosine-kinase inhibitors ) was allowed .


We randomly assigned eligible patients in a @:@ ratio to receive oral afatinib ( @ mg/day ) or intravenous methotrexate ( @ mg/m ( @ ) per week ) , stratified by ECOG performance status and previous EGFR-targeted antibody therapy for recurrent or metastatic disease .


Randomisation was done centrally with an interactive voice or web-based response system .


Clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner .


The primary endpoint was progression-free survival as assessed by an independent , central imaging review committee .


Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug .


This ongoing study is registered with ClinicalTrials.gov , number NCT@ .


Between Jan @ , @ , and Dec @ , @ , we enrolled @ patients and randomly assigned @ to afatinib and @ to methotrexate .


After a median follow-up of @ months ( IQR @-@ ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median @ months -LSB- @ % CI @-@ -RSB- for the afatinib group vs @ months -LSB- @-@ -RSB- for the methotrexate group ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- , p = @ ) .


The most frequent grade @ or @ drug-related adverse events were rash or acne ( @ -LSB- @ % -RSB- of @ patients in the afatinib group vs none of @ patients in the methotrexate group ) , diarrhoea ( @ -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) , stomatitis ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , fatigue ( @ -LSB- @ % -RSB- vs five -LSB- @ % -RSB- ) , and neutropenia ( @ -LSB- < @ % -RSB- vs @ -LSB- @ % -RSB- ) ; serious adverse events occurred in @ ( @ % ) of afatinib-treated patients and @ ( @ % ) of methotrexate-treated patients .


Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile .


These findings provide important new insights into the treatment of this patient population and support further investigations with irreversible ERBB family blockers in HNSCC .


Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population .


We evaluated the immunogenicity and safety of a @-dose infant/toddler regimen of MenACWY-CRM given at @ , @ , @ , and @ months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine ( DTaP-IPV/Hib ) , hepatitis B vaccine ( HBV ) , @ - or @-valent conjugate pneumococcal vaccine ( PCV ) , and measles , mumps , and rubella vaccine ( MMR ) .


Four doses of MenACWY-CRM induced hSBA titers @ in @ % , @ % , @ % , and @ % of participants against serogroups A , C , W-@ , and Y , respectively .


hSBA titers @ were present in @-@ % of participants after the first @ doses .


A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone , except for seroresponse to the pertussis antigen fimbriae .


The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines .


MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations .


Healthy @ month old infants were randomized to receive MenACWY-CRM with routine vaccines ( n = @ ) or routine vaccines alone ( n = @ ) .


Immunogenicity was assessed by serum bactericidal assay using human complement ( hSBA ) .


Medically attended adverse events ( AEs ) , serious AEs ( SAEs ) and AEs leading to study withdrawal were collected throughout the study period .


To compare the efficacy on acute pain treated under the different time of needle retention so as to provide the scientific evidence for the optimization of needle retention time for acupuncture analgesia .


Eighty cases of acute pain ( acute lumbar sprain , stiffness of neck ) were randomized into @ groups .


Acupuncture was applied to all the patients .


After the arrival of needling sensation , the needles were retained for @ min , @ min , @ min and @ min in different groups separately .


For acute lumbar sprain , Ashi ( Extra ) , Houxi ( SI @ ) and Weizhong ( BL @ ) were the main points .


For stiffness of neck , Ashi ( Extra ) , Fengchi ( GB @ ) and Lieque ( LU @ ) were the main points .


McGill pain scale , the internationally recognized pain description and measurement was adopted to observe the indexes and record the score changes of each item of pain symptoms before and @ months after treatment .


The immediate analgesic efficacy under different time of needle retention and the longterm efficacy in follow-up visit @ months after treatment were compared and assessed among the groups .


The scores of visual analogue scale ( VAS ) and present pain intensity ( PPI ) after treatment were all improved significantly as compared with those before treatment in the @ groups ( all P < @ ) , and the result in the @ min group was superior to the other @ groups ( VAS : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ ; PPI : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ , all P < @ ) .


The total effective rate of the immediate analgesia was @ % ( @/@ ) in the @ min group , which was better than that in each of the other @ groups .


The @ min of needle retention achieves the best efficacy of acupuncture analgesia in treatment of acute pain .


The aim of the study was to determine whether experimental manipulation of sense of control would change moderate drinkers ' ( N = @ ) task-specific motivational structure and explicit and implicit determinants of their urge to drink alcohol .


The effects of various levels of information-enhancement and goal-setting on participants ' performance on experimental tasks were assessed .


Participants were randomly assigned to a high-sense-of-control , low-sense-of-control , or no-intervention group .


Dependent measures were indices derived from a task-specific version of the Personal Concerns Inventory and the Shapiro Control Inventory , Alcohol Urge Questionnaire , and alcohol Stroop test .


At baseline , there were no differences among the groups on any of the measures ; however , post-experimentally , induced sense of control had led to increases in adaptive motivation and decreases in explicit and implicit measures of the urge to drink .


The results show that sense of control can be experimentally induced .


This finding has important clinical implications .


To estimate contraceptive efficacy , safety , acceptability , and fit of a single-size diaphragm used with contraceptive gel .


We conducted a multicenter trial in which @ couples used the single-size diaphragm , @ randomized to acid-buffering gel and @ to nonoxynol-@ , for at least @ days and six menstrual cycles .


Visits were at enrollment and after menstrual cycles @ , @ , and @ .


Study outcomes included pregnancy probability , safety , acceptability , and fit .


Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels .


Most ( @/@ -LSB- @ % -RSB- ) women could be fitted with the single-size diaphragm .


A total of @ of @ ( @ % ) provided follow-up .


The @ study pregnancies yielded @-month Kaplan-Meier cumulative typical use pregnancy probabilities per @ women with @ % confidence intervals ( CIs ) of @ ( @-@ @ ) for all users and @ ( @-@ @ ) and @ ( @-@ @ ) with acid-buffering gel and nonoxynol-@ , respectively .


Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of @ compared with @ per @ women for the standard diaphragm ( -LSB- rounded -RSB- difference @ , @ % CI -@ to @ ) .


Approximately half ( @ % ) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis .


Most ( @/@ -LSB- @ % -RSB- ) liked the diaphragm .


Results suggest that if provided by a clinician , @ % ( @ % CI @-@ % ) could insert , correctly position , and remove the diaphragm .


The single-size diaphragm was safe , as effective as a standard diaphragm , and acceptable when used with contraceptive gel .


The present study investigated the effectiveness of a newly developed @-week self-compassion group intervention for enhancing resilience and well-being among female college students .


Fifty-two students were randomly assigned to either an intervention designed to teach skills of self-compassion ( n = @ ) or an active control group intervention in which general time management skills were taught ( n = @ ) .


Both interventions comprised @ group meetings held over @ weeks .


To measure resilience and well-being gains , participants filled out a number of questionnaires before and after the intervention .


Results showed that the self-compassion intervention led to significantly greater increases in self-compassion , mindfulness , optimism , and self-efficacy , as well as significantly greater decreases in rumination in comparison to the active control intervention .


Whereas both interventions increased life satisfaction and connectedness , no differences were found for worry and mood .


These findings suggest that a brief self-compassion intervention has potential for improving student resilience and well-being .


Gram-negative organisms are a major health care concern with increasing prevalence of infection and community spread .


Our primary aim was to characterize the transmission dynamics of frequently encountered gram-negative bacteria in the anesthesia work area environment ( AWE ) .


Our secondary aim was to examine links between these transmission events and @-day postoperative health care-associated infections ( HCAIs ) .


Gram-negative isolates obtained from the AWE ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at @ major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .


The top @ frequently encountered genera were subjected to antibiotic disk diffusion sensitivity to identify epidemiologically related transmission events .


Complete multivariable logistic regression analysis and binomial tests of proportion were then used to examine the relative contributions of reservoirs of origin and within - and between-case modes of transmission , respectively , to epidemiologically related transmission events .


Analyses were conducted with and without the inclusion of duplicate transmission events of the same genera occurring in a given study unit ( first and second case of the day in each operating room observed ) to examine the potential effect of statistical dependency .


Transmitted isolates were compared by pulsed-field gel electrophoresis to disease-causing bacteria for @-day postoperative HCAIs .


The top @ frequently encountered gram-negative genera included Acinetobacter , Pseudomonas , Brevundimonas , Enterobacter , and Moraxella that together accounted for @ % ( @/@ ) of possible transmission events .


For all isolates , @ % ( @/@ ) of possible transmission events were identified by antibiotic susceptibility patterns as epidemiologically related and underwent further study of transmission dynamics .


There were @ duplicates involving within - and between-case transmission events .


Thus , approximately @ % ( @/@ ) of isolates excluding duplicates were considered epidemiologically related .


Contaminated provider hand reservoirs were less likely ( all isolates , odds ratio @ , @ % confidence interval @-@ @ , P = @ ; without duplicate events , odds ratio @ , @ % confidence interval @-@ @ , P = @ ) than contaminated patient or environmental sites to serve as the reservoir of origin for epidemiologically related transmission events .


Within - and between-case modes of gram-negative bacilli transmission occurred at similar rates ( all isolates , @ % between-case , @ % within-case , binomial P value @ ; without duplicates , @ % between-case , @ % within-case , binomial P value @ ) .


Overall , @ % ( @/@ ) of patients suffered from HCAIs and had an intraoperative exposure to gram-negative isolates .


In @ % ( @/@ ) of those patients , gram-negative bacteria were linked by pulsed-field gel electrophoresis to the causative organism of infection .


Patient and provider hands were identified as the reservoirs of origin and the environment confirmed as a vehicle for between-case transmission events linked to HCAIs .


Between - and within-case AWE gram-negative bacterial transmission occurs frequently and is linked by pulsed-field gel electrophoresis to @-day postoperative infections .


Provider hands are less likely than contaminated environmental or patient skin surfaces to serve as the reservoir of origin for transmission events .


Health-related quality of life ( HRQOL ) is an important indicator of well-being in patients with epilepsy .


When assessing changes in HRQOL over time , some of the changes observed may be due to the patients ' change in the internal standards , value , or meaning that they attribute to the HRQOL domain being measured , rather than actual change , a phenomenon known as response shift .


Response shifts are increasingly recognized as an important explanation for the seemingly paradoxical or counterintuitive HRQOL results often observed in chronic conditions .


We investigated the presence of changing values ( reprioritization response shift ) in data from a surgical randomized controlled trial of patients with temporal lobe epilepsy ( TLE ) .


Eighty patients with TLE , who were randomized to surgical and medical treatment , provided data on the epilepsy-specific @-item Quality of life in Epilepsy ( QOLIE-@ ) questionnaire at baseline and @ year after randomization .


Reprioritization response shift among the seven QOLIE-@ domains was assessed using changes in the relative importance weights derived from logistic regression and discriminant analysis .


The relative importance analysis showed a statistically significant increase over time in the importance of social function , but a significant decrease in the relative importance of seizure worry .


There were no significant changes in the relative importance of the remaining five domains in distinguishing between surgical and medical group over time .


Patients that receive surgical treatment are more likely to experience a decrease in the valuation of seizure worry and an increase in the value of social function as compared to patients who are medically treated .


Changes in expectation about seizure freedom and social function may confound the assessment of longitudinal change on these outcomes , and highlight the importance of assessing response shift and the limitations of assessing HRQOL at a single point in time or without a control group .


A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .


Longevity results in changes to patterns of health , with an increased prevalence of chronic diseases .


Parkinson 's disease ( PD ) is described as a progressive neurodegenerative disease related to age that influences quality of life ( QoL ) and leads to depression .


The study intended to assess changes in QoL and depression in older adults with PD through use of Feldenkrais method-based exercise .


The study was a controlled , blinded , and randomized clinical trial .


The study occurred at the University Hospital of the Federal University of Sergipe in Aracaju , Sergipe , Brazil .


Participants were @ patients , aged between @ and @ y , with idiopathic PD , who signed an informed consent form and were randomly assigned to @ groups : treatment and control .


The treatment group underwent @ sessions of an exercise program based on the Feldenkrais method .


The control group received educational lectures during this period .


The treatment group 's @ sessions , given @ / wk on alternate days and lasting @ min , were conducted in an appropriate room at the hospital .


Two surveys , the Parkinson 's Disease Quality of Life ( PDQL ) questionnaire and the Beck Depression Inventory ( BDI ) , were administered before and after the sessions for both groups .


After the exercises based on the Feldenkrais method , the treated group showed improvement in QoL scores ( P = @ ) as well as a reduction in the level of depression ( P = @ ) compared with the control group .


The findings in the current study indicate that it is likely that the practice of a program based on the Feldenkrais method can contribute greatly to the QoL of patients with PD , suggesting the importance of interventions that promote wellness for this population .


Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , is being developed as an adjunct for surgical hemostasis .


Safety and efficacy of Fibrocaps applied directly or by spray device , in combination with gelatin sponge , was compared with that of gelatin sponge-alone in two randomized , single-blind controlled trials : FC-@ US ( United States ) and FC-@ NL ( the Netherlands ) .


A total of @ adult patients were randomized ( Fibrocaps : n = @ -LSB- FC-@ US -RSB- , n = @ -LSB- FC-@ NL -RSB- ; gelatin sponge alone : n = @ -LSB- FC-@ US -RSB- , n = @ -LSB- FC-@ NL ) .


One bleeding site was treated during a surgical procedure ( n = @ ) .


Time to hemostasis ( primary end point ) was measured , with a @-d safety follow-up .


Four surgical indications included hepatic resection ( n = @ ) , spinal procedures ( n = @ ) , peripheral vascular procedures ( n = @ ) , and soft tissue dissection ( n = @ ) .


Mean ( standard deviation ) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone ( FC-@ US : @ -LSB- @ -RSB- versus @ min -LSB- @ -RSB- , P < @ ; FC-@ NL : @ -LSB- @ -RSB- versus @ min -LSB- @ -RSB- , P = @ ) .


The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within @min ( FC-@ US : @ % versus @ % , P < @ ; FC-@ NL : @ % versus @ % , P = @ ) , @min ( @ % versus @ % , P = @ ; @ % versus @ % , P = @ ) , and @min ( @ % versus @ % , P = @ ; @ % versus @ % , P = @ ) .


Adverse events were consistent with surgical procedures performed and patients ' underlying diseases and generally similar between treatment arms ; most were mild or moderate in severity .


Non-neutralizing antithrombin antibodies were detected in @ % of Fibrocaps-treated patients on day@ .


Fibrocaps had good safety and efficacy profiles , supporting continuing clinical development as a novel fibrin sealant .


Refraining from breastfeeding to prevent HIV transmission has been associated with increased morbidity and mortality in HIV-exposed African infants .


The objective was to assess risks of common and serious infectious morbidity by feeding mode in HIV-exposed , uninfected infants @ mo of age with special attention to the issue of reverse causality .


HIV-infected pregnant women from @ sites in Burkina Faso , Kenya , and South Africa were enrolled in the prevention of mother-to-child transmission Kesho Bora trial and counseled to either breastfeed exclusively and cease by @ mo postpartum or formula feed exclusively .


Maternal-reported morbidity ( fever , diarrhea , and vomiting ) and serious infectious events ( SIEs ) ( gastroenteritis and lower respiratory tract infections ) were investigated for @ infants for @ age periods ( @-@ @ and @-@ mo ) by using generalized linear mixed models with breastfeeding as a time-dependent variable and adjustment for study site , maternal education , economic level , and cotrimoxazole prophylaxis .


Reported morbidity was not significantly higher in nonbreastfed compared with breastfed infants -LSB- OR : @ ( @ % CI : @ , @ ) and @ ( @ , @ ) at @-@ @ and @-@ mo of age , respectively -RSB- .


Between @ and @ mo of age , never-breastfed infants had increased risks of morbidity compared with those of infants who were exclusively breastfed ( OR : @ ; @ % CI : @ , @ ; P = @ ) .


The adjusted excess risk of SIEs in nonbreastfed infants was large between @ and @ mo ( OR : @ ; @ % CI : @ , @ ; P = @ ) .


Between @ and @ mo , the OR for SIEs was sensitive to the timing of breastfeeding status , i.e. , @ ( @ % CI : @ , @ ; P = @ ) when defined at end of monthly intervals and @ ( @ % CI : @ , @ ; P = @ ) when defined at the beginning of intervals .


Of @ SIEs , @ mothers reported changes in feeding mode during the SIE although none of the mothers ceased breastfeeding completely .


Not breastfeeding was associated with increased risk of serious infections especially between @ and @ mo of age .


The randomized controlled trial component of the Kesho Bora study was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN@ .


To study the synergistic effects of electroacupuncture on the treatment of knee osteoarthritis after arthroscopic debridement .


From May @ to July @ , @ patients with knee osteoarthritis were randomly divided into two groups .


There were @ patients in the experimental group , including @ males and @ females , ranging in age from @ to @ years , with an average of ( @ + / - @ ) years ; the disease course ranged from @ to @ months , with an average of ( @ + / - @ ) months .


The patients were treated with arthroscopic debridement combined with electroacupuncture after operation .


There were @ patients in the control group , including @ males and @ females , ranging in age from @ to @ years , with an average of ( @ + / - @ ) years ; the disease course ranged from @ to @ months , with an average of ( @ + / - @ ) months .


Those patients were treated only with arthroscopic debridment .


All the patients performed isometric quadriceps femoris contraction exercise and knee flexion and extension activities after operation .


The visual analog scale ( VAS ) score and Lysholm knee score were used to evaluate the therapeutic effects .


All the patients were followed up , and the duration ranged from @ to @ months , with an average of @ months .


At the final follow-up , VAS score was significantly decreased , and the Lysholm score , except for the item demanding for support , significantly increased , compared with those before surgery respectively in both groups .


There was significant difference in VAS score between two groups after treatment .


As to Lysholm score , there were significant differences in limp , pain , swelling , stair activity and squat , but there were no significant differences in items of interlocking and instability between two groups after treatment .


Electroacupuncture can effectively improve the clinical symptoms and knee joint 's motor function of knee joints in patients with knee osteoarthritis , as well as the synergistic effects on the treatment of knee osteoarthritis after arthroscopic debridement , leading to a much better long-term therapeutic effect with respect of improving the function of knee joint .


This therapy , combined with traditional Chinese medicine and Western Medicine , is worth of clinical application in the treatment of knee osteoarthritis .


Preclinical studies suggest that P@X@ receptors are expressed by airway vagal afferent nerves and contribute to the hypersensitisation of sensory neurons .


P@X@ receptors could mediate sensitisation of the cough reflex , leading to chronic cough .


We aimed to investigate the efficacy of a first-in-class oral P@X@ antagonist , AF-@ , to reduce cough frequency in patients with refractory chronic cough .


We did a double-blind , placebo-controlled , two-period , crossover study at one UK centre .


With a computer-generated sequence , we randomly assigned patients with refractory chronic cough to AF-@ , @ mg twice a day , or to placebo ( @:@ ) , and then , after a @ week washout , assigned patients to receive the other treatment .


Patients , health-care providers , and investigators were masked to sequence assignment .


We assessed daytime cough frequency ( primary endpoint ) at baseline and after @ weeks of treatment using @ h ambulatory cough recordings .


The primary analysis used a mixed effects model with the intention-to-treat population .


This study was registered at ClinicalTrials.gov , number NCT@ .


Of @ individuals assessed between Sept @ , @ , and Nov @ , @ , we randomly assigned @ patients ( mean age @ years ; SD @ ) .


In the observed case analysis , cough frequency was reduced by @ % when patients were allocated to AF-@ compared when allocated to placebo ( p = @ ) .


Daytime cough frequency fell from a mean @ coughs per h ( SD @ ) to @ ( @ ) coughs per h after AF-@ treatment versus @ ( @ ) coughs per h to @ ( @ ) coughs per h after placebo .


Six patients withdrew before the end of the study because of taste disturbances , which were reported by all patients taking AF-@ .


P@X@ receptors seem to have a key role in mediation of cough neuronal hypersensitivity .


Antagonists of P@X@ receptors such as AF-@ are a promising new group of antitussives .


Children with borderline to mild intellectual disability ( BMID ) have been shown to be at increased risk for psychosocial problems .


The presence of these psychosocial problems leads to parenting stress .


Stepping Stones Triple P ( SSTP ) is a parenting support program to support parents with children with BMID and psychosocial problems .


The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual ( CAU ) in reducing psychosocial problems in children with BMID .


We conducted a randomized controlled trial in the Northern provinces of the Netherlands .


Parents of children aged @ to @ with borderline ( IQ @ to @ ) or mild ( IQ @ to @ ) ID and psychosocial problems were invited .


Psychosocial problems were identified using the Strengths and Difficulties Questionnaire ( SDQ ) parent report ( @ ) .


Measurements were assessed before the intervention ( T@ ) , immediately after the intervention ( T@ ) and after a follow-up of six months ( T@ ) .


SSTP takes @ to @ individual sessions of @-@ minutes , provided over @ to @weeks .


CAU concerned any service , except SSTP .


Primary outcomes were the child 's psychosocial problems ( SDQ parent and teacher forms and the Eyberg Child Behavior Inventory , ECBI ) .


Secondary outcomes were parenting stress ( Parenting Stress Index , PSI ) and parenting skills ( Alabama Parenting Questionnaire , APQ ) .


In total @ parents of children aged @ to @ with BMID were allocated blindly to either SSTP ( n = @ ) or CAU ( n = @ ) .


In the intention to treat analyses , SSTP achieved no significantly better effect than CAU for the SDQ parent report , the ECBI and the APQ on the short - and long - term .


In the short term , SSTP was significantly more effective than CAU for the SDQ teacher report ( B = -@ , @ % CI -@ to -@ ) and the PSI ( B = -@ , @ % CI -@ to -@ ) .


For both SDQ teacher report and PSI , there was no statistically significant effect in the long term .


Dropout from SSTP was considerable ( @ % ) , with the effects being solely found in the adherent SSTP subgroup .


SSTP had some short-term advantages over CAU , but not in the longer term .


We aimed to assess the safety and tolerability of different doses of canakinumab versus placebo in patients with type @ diabetes mellitus ( T@DM ) .


Data were pooled from three studies in @ T@DM patients with different routes of administration , treatment regimens and follow-up duration .


Canakinumab groups were categorised as low ( @ mg/kg i.v. once ; N = @ ) , intermediate ( @ and @ mg/kg i.v. once , @ and @ mg s.c. monthly ; N = @ ) , medium ( @ mg/kg i.v. once , @ mg s.c. monthly and @ mg s.c. once ; N = @ ) , and high doses ( @ mg/kg i.v. once and @ mg s.c. monthly ; N = @ ) and compared with placebo ( N = @ ) .


Incidences of adverse events ( AEs ) , serious AEs ( SAEs ) , discontinuations due to AEs , deaths , AEs of special interest related to interleukin-@ inhibition and T@DM disease , and laboratory abnormalities related to haematology and biochemistry parameters were reported .


Safety was also analysed by age ( < @ , @ ) and gender .


Average exposure across all groups was@ months ( maximum ~ @ months ) .


No dose response in AEs was observed but a trend towards more patients having at least one AE across canakinumab groups relative to placebo ( P = @ ) was observed .


SAEs were few and the incidence rate for most canakinumab groups was lower than that of placebo group except for the high-dose group ( @ % versus @ % per month in placebo ) .


A total of five patients discontinued treatment due to AEs across treatment groups .


No death was reported in any of the three studies .


A small , non-significant increase in the incidence rate of infection AEs was observed on canakinumab groups relative to placebo .


Canakinumab was associated with mostly mild decreases in WBC , neutrophils and platelet counts .


Additionally , mild increases in SGPT , SGOT and bilirubin were reported .


Overall , despite small differences , no clinically relevant findings were observed with respect to laboratory values and vital signs .


This pooled analysis demonstrated that canakinumab was safe and well tolerated over a treatment period up to @ years at the four pooled doses evaluated , in agreement with safety findings reported in the individual studies .


This study was undertaken to compare the immunogenicity of a three dose and five dose schedule of an oral live-attenuated human rotavirus vaccine , Rotarix in south Indian infants .


Healthy infants ( N = @ ) , six to seven weeks of age were enrolled to receive three doses ( n = @ ) or five doses of Rotarix vaccine ( n = @ ) along with other scheduled vaccines , each dose separated by a four week interval .


Blood samples were taken before vaccination and one month post-dose three in the Rotarix three dose group and one month post-dose five in the Rotarix five dose group ; all were tested for anti-rotavirus IgA by an antibody sandwich enzyme immunoassay .


At baseline , > @ % of infants had > @ units of anti-rotavirus IgA .


The seroconversion rates after three and five doses were low and not significantly different in the two groups .


However , among vaccine responders , children seropositive at baseline showed a much greater absolute increase in IgA antibody levels than children seronegative at baseline .


Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination .


To determine whether outcomes for patients with cellulitis treated with oral antimicrobials are as good as for those who are treated with parenteral antimicrobials .


A prospective randomized non-inferiority trial was conducted at a tertiary teaching hospital in Melbourne , Australia .


Participants were patients referred by the emergency department for treatment of uncomplicated cellulitis with parenteral antimicrobials .


Patients were randomized to receive either oral cefalexin or parenteral cefazolin .


Parenteral antimicrobials were changed to oral after the area of cellulitis ceased progressing .


The primary outcome was days until no advancement of the area of cellulitis .


A non-inferiority margin of @ % was set for the oral arm compared with the parenteral arm .


Secondary outcomes were failure of treatment , pain , complications and satisfaction with care .


This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN@ ) .


Twenty-four patients were randomized to oral antimicrobials and @ to parenteral antimicrobials .


Mean days to no advancement of cellulitis was @ ( SD @ ) for the oral arm and @ ( SD @ ) for the parenteral arm , with a mean difference of -@ ( @ % CI : -@ to +@ ) .


The upper limit of the @ % CI of the difference in means of +@ was below the @ % non-inferiority margin of +@ days , indicating non-inferiority .


More patients failed treatment in the parenteral arm ( @ of @ , @ % ) compared with the oral arm ( @ of @ , @ % ) , although this difference was not statistically significant ( P = @ ) .


Pain , complications and satisfaction with care were similar for both groups .


Oral antimicrobials are as effective as parenteral antimicrobials for the treatment of uncomplicated cellulitis .


This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back , at @months follow-up .


This study is an extended follow-up of an original randomized , controlled trial with registration number NCT@ .


In the present study @ patients in an intervention group and @ patients in a control group were assessed at @months follow-up .


The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from @ to @months after intervention .


Data from three standard measures , Short Form @ ( SF-@ ) , QDS and RDQ were collected at @ , @ and @months follow-up and analyzed through repeated measures analysis of variance .


Despite the similarity between the two groups who completed the @month follow-up in terms of all baseline variables , there were significant differences between the two groups in all domains of the SF-@ scale , as well as QDS and RDQ scales ( P < @ ) .


Also , there were differences within each group over time in the SF-@ domains and disability measurements ( P < @ ) .


The physical function mean score differed significantly when the interaction between groups and time points was examined ( P = @ ) .


This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to @months .


The optimal duration of dual antiplatelet therapy ( DAPT ) following second-generation drug-eluting stent ( DES ) implantation is still debated .


The aim of this study was to test the noninferiority of @ versus @ months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES .


The SECURITY ( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ) trial was a @:@ randomized , multicenter , international , investigator-driven , noninferiority study conducted from July @ to June @ .


Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least @ second-generation DES were eligible .


The primary endpoint was a composite of cardiac death , myocardial infarction ( MI ) , stroke , definite or probable stent thrombosis , or Bleeding Academic Research Consortium ( BARC ) type @ or @ bleeding at @ months .


The main secondary endpoint was a composite of cardiac death , MI , stroke , definite or probable stent thrombosis , or BARC type @ , @ , or @ bleeding at @ and @ months .


Overall , @,@ patients were enrolled in the study and randomized to receive @ months ( n = @ ) versus @months ( n = @ ) DAPT .


The primary composite endpoint occurred , respectively , in @ % versus @ % ( risk difference @ % ; @ % confidence interval -LSB- CI -RSB- : -@ % to @ % ; p = @ ) at @ months .


The upper @ % CI limit was lower than the pre-set margin of @ % , confirming the noninferiority hypothesis ( p < @ ) .


Moreover , no differences were observed in the occurrence of the secondary endpoint at @ months ( @ % vs. @ % , difference : @ % ; @ % CI : -@ to @ ; p = @ ) and between @ and @ months ( @ % vs. @ % , difference : -@ % ; @ % CI : -@ to @ ; p = @ ) .


Finally , no differences were observed in definite or probable stent thrombosis at @ months ( @ % vs. @ % ; difference : -@ % ; @ % CI : -@ to @ ; p = @ ) and between @ and @ months of follow-up ( @ % vs. @ % ; difference : @ % ; @ % CI : -@ to @ ; p = @ ) .


In a low-risk population , the noninferiority hypothesis of @ vs. @ months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death , MI , stroke , definite/probable stentthrombosis , and BARC type @ or @ bleeding at @ months .


( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ; NCT@ ) .


Lafutidine is a new H@-blocker in India claimed to be more potent and effective than existing H@-blockers .


Proton pump inhibitors ( PPIs ) , by virtue of their mechanism of action , have greater efficacy than H@-blockers in gastric acid suppression .


However , clinical trials comparing H@-blockers directly with PPIs are limited .


We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia -LSB- CTRI/@/@ / @ -RSB- .


A prospective , open label , randomized , controlled trial was conducted in a tertiary care hospital .


Ambulatory adult patients with dyspepsia , not yet subjected to endoscopy , were recruited if they had at least moderately severe symptoms , defined as a score of @ on a @-point Global Overall Symptom ( GOS ) Scale .


Those with alarm features or significant comorbidity were excluded .


Subjects received either once daily lafutidine @ mg or pantoprazole @ mg , orally , for @ weeks .


Reflux , dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease ( mFSSGERD ) , and quality of life ( QoL ) by SF-@ scale .


The latter had physical and mental components summarized by physical component summary score ( PCS ) and a mental component summary score ( MCS ) .


Of @ patients enrolled , data of @ on lafutidine and @ on pantoprazole were analyzed .


At @ weeks , proportion of subjects responding ( GOS score @ ) in the two arms ( lafutidine @ % vs. pantoprazole @ % , P = @ ) or showing symptom resolution ( GOS score @ ) ( lafutidine @ % vs. pantoprazole @ % ; P = @ ) were comparable .


Similarly at @ weeks , both responder ( lafutidine @ % vs. pantoprazole @ % ; P = @ ) and symptom resolution proportions ( lafutidine @ % vs. pantoprazole @ % ; P = @ ) were comparable .


Total score on mFSSGERD scale , as well as all its three component scores , and PCS and MCS scores on QoL SF-@ scale showed improvement but no statistically significant difference between the two arms .


Tolerability of both drugs was excellent .


Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia .


An increasing number of patients with heart failure receive implantable cardioverter-defibrillators ( ICDs ) or cardiac resynchronisation defibrillators ( CRT-Ds ) with telemonitoring function .


Early detection of worsening heart failure , or upstream factors predisposing to worsening heart failure , by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes , but the evidence is weak .


We investigated this possibility in IN-TIME , a clinical trial .


We did this randomised , controlled trial at @ tertiary clinical centres and hospitals in Australia , Europe , and Israel .


We enrolled patients with chronic heart failure , NYHA class II-III symptoms , ejection fraction of no more than @ % , optimal drug treatment , no permanent atrial fibrillation , and a recent dual-chamber ICD or CRT-D implantation .


After a @ month run-in phase , patients were randomly assigned ( @:@ ) to either automatic , daily , implant-based , multiparameter telemonitoring in addition to standard care or standard care without telemonitoring .


Investigators were not masked to treatment allocation .


Patients were masked to allocation unless they were contacted because of telemonitoring findings .


Follow-up was @ year .


The primary outcome measure was a composite clinical score combining all-cause death , overnight hospital admission for heart failure , change in NYHA class , and change in patient global self-assessment , for the intention-to-treat population .


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


We enrolled @ patients , of whom @ were randomly assigned ( @ to telemonitoring , @ to control ) .


Mean age was @ years and mean ejection fraction was @ % .


@ ( @ % ) of patients had NYHA functional class II and @ ( @ % ) had NYHA class III .


Most patients received CRT-Ds ( @ ; @ % ) .


At @ year , @ ( @ % ) of @ patients in the telemonitoring group versus @ ( @ % ) of @ in the control group ( p = @ ) had worsened composite score ( odds ratio @ , @ % CI @-@ ) .


Ten versus @ patients died during follow-up .


Automatic , daily , implant-based , multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure .


Such telemonitoring is feasible and should be used in clinical practice .


The aim of this prospective randomized trial was to compare operative factors , postoperative outcomes , and surgical complications of neck dissection ( ND ) when using the harmonic scalpel ( HS ) versus conventional haemostasis ( CH ) ( classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) .


Sixty-one patients who underwent ND with primary head and neck cancer ( HNSCC ) resection were enrolled in this study and were randomized into two homogeneous groups : CH ( conventional haemostasis with classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) and HS ( haemostasis with harmonic scalpel ) .


Outcomes of the study included operative time , intraoperative blood loss , drainage volume , postoperative pain , hospital stay , and incidence of intraoperative and postoperative complications .


The use of the HS reduced significantly the operating time , the intraoperative blood loss , the postoperative pain , and the volume of drainage .


No significant difference was observed in mean hospital stay and perioperative , and postoperative complications .


The HS is a reliable and safe tool for reducing intraoperative blood loss , operative time , volume of drainage and postoperative pain in patients undergoing ND for HNSCC .


Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio .


Pregnancy and lactation in adolescents with low calcium intake may impair fetal growth and infant bone mass .


We investigated the effects of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers consuming low calcium diets ( @ mg/d ) on fetal biometry and infant bone mass , and the relation between infant and maternal bone mass during early lactation .


Infants of mothers who received calcium ( @ mg/d ) plus cholecalciferol ( @ IU/d ) supplementation ( n = @ ) or placebo ( n = @ ) from @ wk of gestation until parturition were studied .


Fetal biometric measurements at @ and @ wk of gestation were obtained from medical records .


Infant anthropometric and total body bone measurements -LSB- bone mineral content ( BMC ) , bone area ( BA ) , and bone mineral density ( BMD ) -RSB- at @ wk postpartum were assessed by dual-energy X-ray absorptiometry .


Maternal BMD z scores for total body , lumbar spine , total hip , and femoral neck at @ wk postpartum were obtained .


Group comparisons were adjusted for significant covariates .


Maternal mean serum @-hydroxyvitamin D was @ nmol/L at baseline in both groups .


No differences in fetal measurements at @ wk of gestation were observed between the groups , except for body weight and its increment from @ to @ wk , which were higher in the supplemented group ( @ % , P = @ and @ % , P = @ , respectively ) .


Infant BMC ( @ @ g ) , BA ( @ @ cm ( @ ) ) , and BMD ( @ @ g/cm ( @ ) ) did not significantly differ between the groups .


In the placebo group , infant BMC and BA were negatively correlated with maternal BMD z scores for total body ( r = -@ and r = -@ ; P < @ ) and hip ( r = -@ and r = -@ ; P < @ ) .


In contrast , no correlations were observed in the supplemented group .


Calcium and vitamin D supplementation of the adolescents studied resulted in higher fetal body weight at @ wk of gestation and had no effect on infant bone mass at @ wk postpartum .


Because correlations between maternal and infant bone mass were evident only in the placebo group , infant bone mass appeared to be more dependent on maternal skeletal mass when calcium intake was low .


This trial was registered at clinicaltrials.gov as NCT@ .


Skill readiness remains a challenge for all health care professionals who are involved in direct patient care .


Researchers suggest that skill retention may decrease within @ months of an educational session .


The purpose of this study was to explore competency retention for high-risk , low-frequency procedures , specifically , managing a difficult airway and placing a laryngeal mask airway , using a web-based content refresher .


The pilot study was conducted in two sessions .


Session one established clinical skill competency .


Six months later , the advanced practice RNs were randomized into two groups .


Group @ reviewed didactic content and participated in a complex airway management simulation .


Group @ participated only in a complex airway management simulation .


This study showed a positive trend in maintaining competency for a low-frequency procedure for which complex airway management was given , using web-based content review .


It is feasible to maintain competency for low-frequency procedures using web-based content refreshers .


This pilot study benefited advanced practice nurses by providing them with the potential to maintain competency in this high-risk , low-frequency procedure .


Continuing education is an important consideration for health care organizations .


Breast cancer accounts for almost @ % of all cancers and is the second leading cause of cancer deaths in women in Scotland .


Screening is key to early detection .


The Scottish Breast Screening Programme is a nationwide , free at point of delivery screening service , to which all women aged between @ and @ years are invited to attend every @ years .


Currently over three-quarters of invited women regularly attend screening .


However , women from more deprived areas are much less likely to attend : for example in the @ years from @-@ only @ % of women in the most deprived area attended the East of Scotland Breast Screening programme versus @ % in the least deprived .


Research has suggested that reminders ( telephone or letter ) and brief , personalised interventions addressing barriers to attendance may be helpful in increasing uptake in low-income women .


We will employ a brief telephone reminder and support intervention , whose purpose is to elicit and address any mistaken beliefs women have about breast screening , with the aim that the perceived benefits of screening come to outweigh any perceived barriers for individuals .


We will test whether this intervention , plus a simple anticipated regret manipulation , will lead to an increase in the uptake of breast cancer screening amongst low-income women who have failed to attend a first appointment , in a randomised controlled trial with @ women .


Participants will be randomly allocated to one of four treatment arms i.e. @ ) Letter reminder ( i.e. Treatment as usual : CONTROL ) ; @ ) Telephone reminder ( TEL ) , @ ) Telephone reminder plus telephone support ( TEL-SUPP ) and @ ) Telephone reminder plus support plus AR ( TEL-SUPP-AR ) .


The primary outcome will be attendance at breast screening within @ months of the reminder letter .


If this simple telephone support intervention ( with or without AR intervention ) leads to a significant increase in breast screening attendance , this would represent a rare example of a theoretically-driven , relatively simple psychological intervention that could result in earlier detection of breast cancer amongst an under-served group of lower socio-economic women .


Brief physician counselling has been shown to be effective in improving smokers ' behaviour .


If the counselling sessions can be given at the workplace , this would benefit a larger number of smokers .


This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour .


This prospective randomised control trial was conducted on smokers in a factory .


A total of @ participants were recruited and randomised into control and intervention groups using a table of random numbers .


The intervention group received a ten-minute brief physician counselling session to quit smoking .


Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline , one month and three months post intervention .


There was a significant improvement in smoking behaviour at one-month post intervention ( p = @ , intention to treat analysis ; OR = @ ; CI = @-@ @ ) .


This was not significant at three-month post intervention ( p = @ , intention to treat analysis ; OR = @ ; @ % CI = @-@ @ ) .


A session of brief physician counselling was effective in improving smokers ' behaviour at workplace , but the effect was not sustained .


Chronic tinnitus negatively affects the quality of life for millions of people .


This clinical trial assesses a potential treatment for tinnitus .


To determine if repetitive transcranial magnetic stimulation ( rTMS ) can reduce the perception or severity of tinnitus and to test the hypothesis that rTMS will result in a statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group .


A randomized , participant and clinician or observer-blinded , placebo-controlled clinical trial of rTMS involving individuals who experience chronic tinnitus .


Follow-up assessments were conducted at @ , @ , @ , @ , and @ weeks after the last treatment session .


The trial was conducted between April @ and December @ at Portland Veterans Affairs Medical Center among @ individuals with chronic tinnitus who were initially screened for participation .


Of those , @ provided informed consent and underwent more detailed assessments .


Seventy individuals met criteria for inclusion and were randomized to receive active or placebo rTMS .


Sixty-four participants ( @ men and @ women , with a mean -LSB- SD -RSB- age of @ -LSB- @ -RSB- years ) were included in the data analyses .


No participants withdrew because of adverse effects of rTMS .


Participants received @ pulses per session of active or placebo rTMS at a rate of @-Hz rTMS daily on @ consecutive workdays .


The Tinnitus Functional Index ( TFI ) was the main study outcome .


Our hypothesis was tested by comparing baseline and posttreatment TFIs for each participant and group .


Overall , @ of @ participants ( @ % ) in the active rTMS group and @ of @ participants ( @ % ) in the placebo rTMS group were responders to rTMS treatment .


The difference in the percentage of responders to treatment in each group was statistically significant ( ( @ ) ( @ ) = @ , P < @ ) .


Application of @-Hz rTMS daily for @ consecutive workdays resulted in a statistically significantly greater percentage of responders to treatment in the active rTMS group compared with the placebo rTMS group .


Improvements in tinnitus severity experienced by responders were sustained during the @-week follow-up period .


Before this procedure can be implemented clinically , larger studies should be conducted to refine treatment protocols .


The aim of the current study was to compare block of the sciatic nerve through the anterior approach by two methods , namely , the nerve-stimulator guided and ultrasound-guided , with or without nerve stimulation , with regard to the ease of performance , reliability and safety of this approach .


@ adult patients were randomly allocated equally into one of @ main groups : `` Nerve Stimulator-Guided Group ( NSG ) '' where the nerve was located by nerve stimulator only and `` Ultrasound guided group ( USG ) '' where the sciatic nerves were blocked by a stimulated needle under guidance of the ultrasound .


Assessment of performing each technique , sensory and motor blockades , occurrence of acute systemic toxicity and haematoma formation were compared .


Only one-third of the sciatic nerves could be visualized by US .


This did not affect the block execution time but caused less number of needle passes in a statistically significant value .


Sensory and motor block showed significant differences between the @ groups .


Criteria of acute systemic toxicity and occurrence of hematoma were not reported in both groups .


Results of the current study showed that the addition of ultrasound to nerve stimulator in the anterior approach to the sciatic nerve block added only little to the ease of performance , reliability and safety .


This was because only one-third of the nerves could be seen .


More practice , better machines and new blocking techniques may be needed to overcome the problem of anisotropy of the nerve .


To investigate how radiotherapy ( XRT ) adds to tumor control using a standardized surgical technique with meticulous control of surgical margins in a randomized trial with @ years of follow-up .


Three hundred eighty-one women with pT@N@ breast cancer were randomly assigned to sector resection with ( XRT group ) or without ( non-XRT group ) postoperative radiotherapy to the breast .


With follow-up through @ , we estimated cumulative proportion of recurrence , breast cancer death , and all-cause mortality .


The cumulative probability of a first breast cancer event of any type after @ years was @ % in the XRT group and @ % in the non-XRT group ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) .


The benefit of radiotherapy was achieved within the first @ years .


After @ years , @ % of the women in the XRT group died compared with @ % in the non-XRT group ( HR , @ ; @ % CI , @ to @ ) .


The cumulative probability of contralateral cancer or death as a result of cancer other than breast cancer was @ % in the XRT group and @ % in the non-XRT group ( HR , @ ; @ % CI , @ to @ ) .


In an anticipated low-risk group , the cumulative incidence of first breast cancer of any type was @ % in the XRT group and @ % in the non-XRT group ( HR , @ ; @ % CI , @ to @ ) .


Radiotherapy protects against recurrences during the first @ years of follow-up , indicating that XRT mainly eradicates undetected cancer foci present at primary treatment .


The similar rate of recurrences beyond @ years in the two groups indicates that late recurrences are new tumors .


There are subgroups with clinically relevant differences in risk .


Patients undergoing cardiac surgery presenting with chronic obstructive pulmonary disease ( COPD ) have a higher @-day mortality risk .


In these patients , pulmonary dysfunction linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass ( CPB ) , which causes pulmonary hypoperfusion .


We hypothesize that selective pulmonary perfusion ( sPP ) of the lungs leads to a reduction of pulmonary inflammation and a better clinical outcome .


Fifty-nine COPD patients ( forced expiratory volume in @ s/vital capacity < @ % ) undergoing cardiac surgery procedures ( coronary artery bypass grafting @ % , valve @ % ) were block-randomized to sPP ( venous blood , temperature @C , @ l ) or standard CPB ( @/@ ) .


The primary end-point of the study was to evaluate the effect of pulmonary perfusion on gas exchange by measuring alveolar-arterial oxygen gradient .


The surrogate end-points were inflammatory response , intensive care unit ( ICU ) stay , time on respirator ( TOR ) and major adverse cardiac and cerebrovascular events .


A cytokine assay for interleukin-@ , IL-@ , IL-@ , tumour necrosis factor - ( TNF - ) and polymorphonuclear elastase was performed with peripheral blood at different time-points -LSB- ( t@ ) pre-CPB , ( t@ ) end of CPB , ( t@ ) @ h , ( t@ ) @ h , ( t@ ) @ h postoperatively -RSB- .


Repeated-measure analysis of variance and non-parametric statistics were used to assess the between-group and during time differences .


The two groups proved comparable for perioperative variables .


Serum cytokines were not different in the two groups throughout the study ( P > @ at single time-points ) , but as a function of time , the markers of the inflammatory response increased after CBP ( P < @ pre-CPB to @ h ) .


Clinical end-points were statistically comparable in both groups , but with a trend towards a shorter TOR ( @ @ h/@ @ h ) and ICU stay ( @ @ days/@ @ @ days ) in the sPP group despite a slightly longer time on extracorporeal circulation ( @ vs @ min ) .


These results indicate a non-significant trend that repeated hypothermic lung perfusion with venous blood during CPB may have a protective effect on the lungs .


A multicentre study design and larger cohort seem necessary to demonstrate the benefits of sPP more clearly .


This study compared efficacy and safety of the selective relaxant binding agent sugammadex ( @mg/kg ) with neostigmine ( @g/kg ) for neuromuscular blockade ( NMB ) reversal in Chinese and Caucasian subjects .


This was a randomized , active-controlled , multicenter , safety-assessor-blinded study ( NCT@ ) in American Society of Anesthesiologists Class @-@ subjects undergoing surgery with propofol anesthesia .


Rocuronium @ mg/kg was administered for endotracheal intubation , with @-@ @ mg/kg maintenance doses given as required .


NMB was monitored using TOF-Watch ( ) SX .


At second twitch reappearance , after last rocuronium dose , subjects received sugammadex @mg/kg or neostigmine @g/kg plus atropine @-@g / kg , according to randomization .


Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four ( TOF ) ratio to @ .


Overall , @ Chinese subjects ( sugammadex , n = @ , neostigmine , n = @ ) ; and @ Caucasian subjects ( sugammadex , n = @ , neostigmine , n = @ ) had evaluable data .


Geometric mean ( @ % CI ) time to recovery to TOF ratio @ was @ ( @-@ @ ) min with sugammadex vs @ ( @-@ @ ) min with neostigmine in Chinese subjects .


Corresponding times for Caucasian subjects were @ ( @-@ @ ) min and @ ( @-@ @ ) min , respectively .


Sugammadex @mg/kg was generally well tolerated , with no serious adverse events reported .


There was no residual NMB or recurrence of NMB .


Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex @mg/kg vs neostigmine @g/kg , with a ~ @ times ( p < @ ) faster recovery with sugammadex vs neostigmine in Chinese subjects .


Sugammadex was generally well tolerated .


Little is known about the factors that predict for gastrointestinal stromal tumor ( GIST ) recurrence in patients treated with adjuvant imatinib .


Risk factors for GIST recurrence were identified , and @ risk stratification scores were developed using the database of the Scandinavian Sarcoma Group ( SSG ) XVIII trial , where @ patients with high-risk GIST with no overt metastases were randomly assigned to adjuvant imatinib @ mg/day either for @ or @ months after surgery .


The findings were validated in the imatinib arm of the American College of Surgeons Oncology Group Z@ trial , where @ patients with GIST were randomized to receive imatinib and @ were to receive placebo for @ months .


Five factors ( high tumor mitotic count , nongastric location , large size , rupture , and adjuvant imatinib for @ months ) were independently associated with unfavorable recurrence-free survival ( RFS ) in a multivariable analysis in the SSGXVIII cohort .


A risk score based on these @ factors had a concordance index with GIST recurrence of @ % .


When a simpler score consisting of the @ strongest predictive factors ( mitotic count and tumor site ) was devised , the groups with the lowest , intermediate high , and the highest risk had @-year RFS of @ % , @ % , and @ % , respectively .


Both scores were strongly associated with RFS in the validation cohort ( P < @ for each comparison ) .


The scores generated were effective in stratifying the risk of GIST recurrence in patient populations treated with adjuvant imatinib .


Patients with nongastric GIST with a high mitotic count are at a particularly high risk for recurrence .


To evaluate both the short - and long-term effectiveness of a lifestyle intervention on physical fitness in adolescents and young adults with cerebral palsy ( CP ) .


Single-blind , randomized controlled trial .


University hospitals and rehabilitation clinics .


Adolescents and young adults ( N = @ ) with spastic CP classified in Gross Motor Function Classification System levels I through IV ; of these , @ completed the study .


A @-month lifestyle intervention consisting of physical fitness training combined with counseling sessions focused on physical behavior and sports participation .


Physical fitness , including measures of cardiopulmonary fitness , muscle strength , and body composition .


Favorable short - and medium-term effects were found for peak oxygen consumption , oxygen consumption , and load on the anaerobic threshold and waist circumference .


Favorable long-term effects were found for sum of skinfolds , systolic blood pressure , and total cholesterol .


This exploratory study showed that the lifestyle intervention was effective in improving cardiopulmonary fitness and body composition .


Effects of body composition were maintained in the long term .


However , the intervention needs to be optimized to increase muscle strength and for long-term retention of effects on aerobic capacity .


Arterial and thromboembolic pulmonary hypertension ( PH ) lead to arterial hypoxaemia .


To investigate whether cerebral tissue oxygenation ( CTO ) in patients with PH is reduced and whether this is associated with reduced exercise tolerance .


@ patients with PH ( mean pulmonary arterial pressure @ mmHg , @ arterial , @ chronic thromboembolic ) and @ controls underwent right heart catheterisation with monitoring of CTO at rest , during maximal bicycle exercise and during inhalation of oxygen and NO .


The @ min walk distance ( @MWD ) was measured .


Median CTO in PH-patients at rest was @ % ( quartiles @ ; @ ) , during exercise @ % ( @ ; @ ) ; corresponding values in controls were @ % ( @ ; @ ) ( P = NS ) and @ % ( @ ; @ ) ( p = @ vs. PH ) .


Inhalation of NO and oxygen improved CTO in PH. In multivariate regression analysis CTO at maximal exercise predicted the work load achieved when controlled for age , pulmonary vascular resistance and mixed venous oxygen saturation ( R ( @ ) = @ , p < @ ) ; in addition , the @MWD was predicted by CTO ( adjusted R ( @ ) = @ , p < @ ) .


In PH-patients but not in controls CTO decreased during exercise .


Since CTO was an independent predictor of the work load achieved and the @MWD cerebral hypoxia may contribute to exercise limitation in PH. Clinicaltrials.gov : NCT@ .


A lipid emulsion composed of soybean oil ( long-chain triglycerides , LCT ) , medium-chain triglycerides ( MCT ) and n-@ poly-unsaturated fatty acids ( PUFAs ) was evaluated for immune-modulation efficacy , safety , and tolerance in patients undergoing major surgery for gastric and colorectal cancer .


In a prospective , randomized , double-blind study , @ patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group , receiving the n-@ PUFAs enriched intravenous fat emulsion ( IVFE ) , or the control group , receiving a lipid emulsion comprised of soybean oil and MCTs ( @ - @gkg-@day-@ ) as part of total parenteral nutrition ( TPN ) regimen from surgery ( day -@ ) up to post-operative day @ .


Safety and efficacy parameters were assessed on day -@ and post-operative visits on day @ , @ , and @ .


Adverse events were documented daily and compared between the groups .


Pro-inflammatory markers , laboratory parameters , and adverse events did not differ prominently between the @ groups , with the exception of net changes ( day @ minus day -@ ) of free fatty acids ( FFAs ) , triglyceride , and high-density lipoprotein ( HDL ) .


Net decrease of FFAs was remarkably higher in the study group , while the net increase of triglyceride and decrease of HDL was significantly lower .


The n-@ PUFA-enriched IVFE showed improvements in lipid metabolism .


In respect of efficacy , safety and tolerance both IVFE were comparable .


In patients with severe stress , there is an inflammation-attenuating effect of n-@ PUFAs .


Further , adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients .


Butter is rich in saturated fat -LSB- saturated fatty acids ( SFAs ) -RSB- and can increase plasma low density lipoprotein ( LDL ) cholesterol , which is a major risk factor for cardiovascular disease .


However , compared with other dairy foods , butter is low in milk fat globule membrane ( MFGM ) content , which encloses the fat .


We hypothesized that different dairy foods may have distinct effects on plasma lipids because of a varying content of MFGM .


We aimed to investigate whether the effects of milk fat on plasma lipids and cardiometabolic risk markers are modulated by the MFGM content .


The study was an @-wk , single-blind , randomized , controlled isocaloric trial with @ parallel groups including overweight men and women ( n = @ randomly assigned ) .


For the intervention , subjects consumed @ g milk fat/d as either whipping cream ( MFGM diet ) or butter oil ( control diet ) .


Intervention foods were matched for total fat , protein , carbohydrates , and calcium .


Subjects were discouraged from consuming any other dairy products during the study .


Plasma markers of cholesterol absorption and hepatic cholesterol metabolism were assessed together with global gene-expression analyses in peripheral blood mononuclear cells .


As expected , the control diet increased plasma lipids , whereas the MFGM diet did not -LSB- total cholesterol ( SD ) : +@ @ compared with -@ @ mmol/L , respectively ( P = @ ) ; LDL cholesterol : +@ @ compared with +@ @ mmol/L , respectively ( P = @ ) ; apolipoprotein B : apolipoprotein A-I ratio : +@ @ compared with -@ @ mmol/L , respectively ( P = @ ) ; and non-HDL cholesterol : +@ @ compared with -@ @ mmol/L , respectively ( P = @ ) -RSB- .


HDL-cholesterol , triglyceride , sitosterol , lathosterol , campesterol , and proprotein convertase subtilisin/kexin type @ plasma concentrations and fatty acid compositions did not differ between groups .


Nineteen genes were differentially regulated between groups , and these genes were mostly correlated with lipid changes .


In contrast to milk fat without MFGM , milk fat enclosed by MFGM does not impair the lipoprotein profile .


The mechanism is not clear although suppressed gene expression by MFGM correlated inversely with plasma lipids .


The food matrix should be considered when evaluating cardiovascular aspects of different dairy foods .


This trial was registered at clinicaltrials.gov as NCT@ .


To observe differences of therapeutic effect between acupuncture combined with bloodletting and regular western medication on chronic urticarial .


One hundred and sixty patients were randomly divided into an acupuncture bloodletting group and a loratadine group , @ cases in each group .


In the acupuncture bloodletting group , Quchi ( LI @ ) , Neiguan ( PC @ ) , Xuehai ( SP @ ) and Sanyinjiao ( SP @ ) were selected and manipulated with reducing method , and pricking bloodletting with three-edge needle and cupping were given at Feishu ( BL @ ) and Geshu ( BL @ ) , once every other day .


The oral administration of @ mg loratadine was applied in the loratadine group , once a day .


The therapeutic effect in two groups was observed and compared after four weeks .


The cured and markedly effective rate was @ % ( @/@ ) in the acupuncture bloodletting group , which was similar to @ % ( @/@ ) in the loratadine group ( P > @ ) .


The scores of symptom-sign in the two groups were reduced after treatment ( @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , both P < @ ) , but there was no statistically significant difference between two groups after treatment ( P > @ ) .


There was no obvious adverse effect in the acupuncture bloodletting group while @ cases of mild somnolence were reported in the loratadine group .


The acupuncture bloodletting is an effective method for chronic urticarial , which has similar effect to loratadine without adverse effect .


Reducing the wound healing time is crucial in wound as it lowers the chance of infection and decreases complications and cost .


Grape seed extract has the ability to release endothelial growth factor and its topical application results in contraction and closure of the skin wound .


Furthermore , it possesses antioxidant and antibacterial properties .


In several studies it has been proved effective in animals .


Therefore , due to low side effects and recognition of herbal medicine , we decided to evaluate the effect of grape seed extract @ % herbal cream on human skin lesions .


This study is a double blind clinical trial conducted on two groups of treatment and placebo .


Surgery was performed on skin lesions such as skin tags and moles which were found on the neck , trunk and limbs ( except for face ) .


After enrollment and obtaining informed consent from participants , they were randomized into two groups of treatment and placebo .


Excision of the lesions was done by surgical scissors .


The lesions got restored by secondary intention method .


After the first day of treatment , the patients were visited on the @rd , @th , @th , @th , and @st day .


Grape seed extract cream @ % was produced and coded by the Faculty of Pharmacy , Ahvaz University of Medical Sciences .


In order to compare the two groups , T-test was used .


For time assessing , analysis of variance with repeated measures was employed .


The results showed complete repair of wounds averagely on day @ for the treatment group and on day @ for the placebo group , which was clearly significant in terms of statistical difference ( p = @ ) .


Proanthocyanidins in grape seed extract trigger the release of vascular endothelial growth factor and its topical application causes wound contraction and closure .


Curing skin lesions with grape seed extract caused proliferation areas with protected boundaries in epithelium , increased cell density and increased deposition of connective tissue at the wound site which in general improves cellular structure in wound .


In addition , its anti-inflammatory and anti-microbial properties are effective in wound healing .


We tested if an increase in immune activation and a decrease in CD@ T cells induced by different antigenic stimuli could be associated with changes in the thymic function and the interleukin ( IL ) -@ / CD@ system .


Twenty-six HIV-infected patients under combined antiretroviral therapy ( cART ) were randomized to receive , during @ months , a complete immunization schedule ( @ vaccines and @ doses ) or placebo .


Thereafter , cART was interrupted during @ months .


Changes in the thymic function and the IL-@ / CD@ system after @ different antigenic stimuli ( vaccines , episodes of low-level intermittent viremia before cART interruption , or viral load rebound after cART interruption ) were assessed .


During the period on cART , neither vaccines nor low-level viremia influenced thymic function or IL-@ / CD@ system parameters .


By analyzing the cohort as a whole while on cART , a significant improvement was observed in the thymic function as measured by an increase in the thymic volume ( P = @ ) , T-cell receptor excision circle-bearing cells ( P = @ ) , and naive CD@ and CD@ T cells ( P = @ both ) .


No significant changes were observed in the IL-@ / CD@ system .


After cART interruption , a decrease in T-cell receptor excision circles ( P < @ ) and naive CD@ T cells ( P < @ ) , an increase in IL-@ and expression of CD@ on naive and memory CD@ T cells ( P = @ , P = @ , and P = @ , respectively ) , and a significant decrease in CD@ on naive and memory CD@ T cells ( P = @ , P = @ , respectively ) were observed .


Low-level transient antigenic stimuli during cART were not associated with changes in the thymic function or the IL-@ / CD@ system .


Conversely , viral load rebound very early after cART interruption influenced the thymic function and the IL-@ / CD@ system .


Clinical Trials.gov number NCT@ .