The difference in average itch intensity ( Weighted Mean Over 15 Mins ) between the 3 % dose of SB705498 and placebo for the cowhage challenge was -0.64 , whilst the histamine challenge showed on average a -4.65 point change .


The 3 % topical formulation of SB705498 cream was clinically well tolerated and had target specific pharmacodynamic activity .


However there were no clinically significant differences on pruritus induced by either challenge agent in comparison to placebo .


SB705498 is unlikely to be of symptomatic benefit for histaminergic or non-histaminergic induced itch .


ClinicalTrials.gov NCT01673529 .


The type 2 Diabetes Mellitus treatment is currently effective but still not ideal .


A therapy based on the incretins , which represents a significant qualitative progress , is close to an ideal .


The first completed mortality study with dipeptidyl peptidase ( DPP4 ) inhibitors is the study called SAVOR as presented in Amsterdam during the European Cardiology Congress in 2013 .


SAVOR ( Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus ) randomised 16,492 patients with Type 2 Diabetes Mellitus and a high-risk of cardiovascular events treated with current per oral antidiabetics and patients treated with saxagliptin or placebo .


Eight thousand eight hundred and twenty patients were randomised to be treated with saxagliptin and 8,212 were randomised to be treated with placebo .


The average monitored period was 2.1 years .


The primary goal ( cardiovascular death , nonfatal myocardial infarction and nonfatal CMP ) occurred in 7.3 % ( 613 ) patients treated with saxagliptin and in 7.2 % ( 609 ) patients treated with placebo ( HR 1.00 , p < 0.001 for non inferiority ) .


The main secondary goal ( cardiovascular death , myocardial infarction , vascular stroke , hospitalisation for a heart failure or angina pectoris and myocardial revascularisation ) occurred in 12.8 % ( 1,059 ) patients treated with saxagliptin and in 12.4 % ( 1,034 ) patients treated with placebo .


The number of hospitalisations for heart failure was 289 ( 3.5 % ) in the group treated with saxagliptin and 228 ( 2.8 % ) in the group treated with placebo ( p = 0.007 ) .


DPP4 inhibitor saxagliptin did not increase the occurrence of ischemic cardiovascular events but it inclined to an increased hospitalisation for heart failure in patients with the already present heart failure .


It did not increase the occurrence of pancreatitis .


Simultaneously it significantly improved the Diabetes Mellitus control , which could signal a future improvement in cardiovascular goals .


Patients with antiplatelet and antithrombotic therapy ( AP/AT ) represent a substantial proportion of ear , nose and throat ( ENT ) patients .


Despite the ubiquitous consideration of bleeding and ischemic/thrombembolic risk , no detailed assessment of the perioperative setting in an ENT cohort is available in the literature .


The goal of the present work is to give a detailed assessment of patients with AP/AT in an ENT cohort resulting in ENT-specific recommendations for daily routine .


In all , 400 randomized patients were asked regarding analgetic therapy in acute pain .


Medical data of 5211patients who underwent head and neck surgery were analyzed for AP/AT therapy .


Therapeutic strategies , the perioperative AP/AT therapy , duration of intensive care treatment and hospitalization ( ICT/H ) , application of erythrocytes and internistic/neurolocigal complication data were analyzed in patients with/without AP/AT .


Nearly 75 % of our patients were taking AP/AT due to coronary heart disease ( CHD ) , peripheral arterial disease ( PAD ) , cardiac arrhythmia , or cardiovascular disease ( CVD ) .


Patients ' questionnaire revealed that 31 % of our patients use acetylsalicylic acid in acute pain , which represents 10 % of the overall AP/AT cohort .


Head and neck surgery in patients with AP/AT showed an elevated bleeding frequency ( p = 0.006 ) without an elevated risk for internistic/neurological complications .


ICT/H were remarkably prolonged ( p = 0.006 ; p = 0.0004 ) .


Head and neck surgery in patients with AP/AT can be routinely performed .


Indication for intensive care , endotracheal intubation , and tracheostomy should be made generously due to high requirements of airway management in ENT .


Ischemic/thrombembolic and bleeding risk requires careful assessment in an interdisciplinary setting .


The mechanism of reflux protection may involve a ` flap valve ' at the oesophago-gastric junction ( OGJ ) .


To assess the effects of baclofen , a gamma-aminobutyric acid receptor type-B ( GABA-B ) agonist known to suppress reflux events , on the ` functional anatomy ' of the OGJ and proximal stomach after a large test meal .


Twelve healthy volunteers ( HVs ) and 12 patients with gastro-oesophageal reflux disease ( GERD ) ; with erosive oesophagitis or pathological oesophageal acid exposure completed a randomised , double-blind , cross-over study .


On 2 test days participants received 40-mg baclofen or placebo before ingestion of a large test meal .


OGJ structure and function were assessed by high-resolution manometry ( HRM ) and magnetic resonance imaging ( MRI ) using validated methods .


Measurements of the oesophago-gastric angle were derived from three-dimensional models reconstructed from anatomic MRI images .


Cine-MRI and HRM identified postprandial reflux events .


Mixed model analysis and Wilcoxon rank signed tests assessed differences between participant groups and treatment conditions .


In both HVs and GERD patients , baclofen reduced the frequency of postprandial reflux events .


The oesophago-gastric insertion angle in GERD patients was reduced ( -4.1 1.8 , P = 0.025 ) , but was unchanged in healthy controls .


In both study groups , baclofen augmented lower oesophageal sphincter ( LES ) pressure ( HVs : +7.3 1.8 mmHg , P < 0.0001 , GERD : +4.50 1.49 mmHg , P < 0.003 ) and increased LES length ( HVs : +0.48 0.11 cm , P < 0.0003 , GERD : +0.35 0.06 cm , P < 0.0001 ) .


Baclofen inhibits transient LES relaxations and augments LES pressure and length .


Additionally , baclofen has effects on the ` functional anatomy ' of the OGJ and proximal stomach in GERD patients , which may suppress reflux by means of a ` flap valve ' mechanism .


The aim of the current study is to compare the accuracy of the ultrasound ( US ) versus clinical assessment for determination of the spinal level , using X-ray as the Gold Standard for control .


200 patients were randomized into two equal groups .


Patients in the Clinical Group were examined by landmarks to assess the Assumed Clinical Tuffier 's Line , and then by fluoroscopy to determine the True Clinical Tuffier 's Line .


Patients in the Ultrasound Group were examined by the ultrasound to determine the Ultrasound Tuffier 's Line .


The results of both groups were compared in relation to the plain X-ray , done for each patient , which determined the Radiological Tuffier 's Line .


In the Clinical Group , the True Clinical Tuffier 's line met the Assumed Tuffier 's line in only 12 % of the patients .


In the remaining patients , wrong leveling ranged from one space above in 80 % to 2 spaces above in 7 % and in 1 % of patients the line was at L2 .


In the Ultrasound Group , wrong leveling occurred in 22 % of patients .


The Ultrasound misidentification was less than one level in 17 % and one level in 5 % of patients .


Ultrasound examination had a true limitation of 2 % of patients .


Ultrasound examination of the spine is recommended in patients planned for spinal anesthesia , as it is superior to clinical assessment in identification of the interspinous levels .


This will decrease the hazard of spinal cord trauma .


The purpose of this study was to evaluate the clinical outcomes of cografting of acellular dermal matrix with autologous split-thickness skin and autologous split-thickness skin graft alone for full-thickness skin defects on the extremities .


In this prospective randomized study , 19 consecutive patients with full-thickness skin defects on the extremities following trauma underwent grafting using either cograft of acellular dermal matrix with autologous split-thickness skin graft ( nine patients , group A ) or autologous split-thickness skin graft alone ( 10 patients , group B ) from June of 2011 to December of 2012 .


The postoperative evaluations included observation of complications ( including graft necrosis , graft detachment , or seroma formation ) and Vancouver Scar Scale score .


No statistically significant difference was found regarding complications , including graft necrosis , graft detachment , or seroma formation .


At week 8 , significantly lower Vancouver Scar Scale scores for vascularity , pliability , height , and total score were found in group A compared with group B.


At week 12 , lower scores for pliability and height and total scores were identified in group A compared with group B.


For cases with traumatic full-thickness skin defects on the extremities , a statistically significant better result was achieved with cograft of acellular dermal matrix with autologous split-thickness skin graft than with autologous split-thickness skin graft alone in terms of Vancouver Scar Scale score .


Therapeutic , II .


If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present standard .


Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects .


We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects .


Patients with T1-2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised , multicentre , open-label , phase 3 non-inferiority EORTC 10981-22023 AMAROS trial .


Patients were randomly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution .


The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group .


Analyses were by intention to treat and per protocol .


The AMAROS trial is registered with ClinicalTrials.gov , number NCT00014612 .


Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were eligible for randomisation .


2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy .


Of the 1425 patients with a positive sentinel node , 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy ; these patients constituted the intention-to-treat population .


Median follow-up was 61 years ( IQR 41-80 ) for the patients with positive sentinel lymph nodes .


In the axillary lymph node dissection group , 220 ( 33 % ) of 672 patients who underwent axillary lymph node dissection had additional positive nodes .


Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group .


5-year axillary recurrence was 043 % ( 95 % CI 000-092 ) after axillary lymph node dissection versus 119 % ( 031-208 ) after axillary radiotherapy .


The planned non-inferiority test was underpowered because of the low number of events .


The one-sided 95 % CI for the underpowered non-inferiority test on the hazard ratio was 000-527 , with a non-inferiority margin of 2 .


Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year , 3 years , and 5 years .


Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1-2 primary breast cancer and no palpable lymphadenopathy .


Axillary radiotherapy results in significantly less morbidity .


EORTC Charitable Trust .


A constructive safety culture is essential for the successful implementation of patient safety improvements .


To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture .


A three-arm cluster randomised trial was conducted in a mixed method study , studying the effect of administering a patient safety culture questionnaire ( intervention I ) , the questionnaire complemented with a practice-based workshop ( intervention II ) and no intervention ( control ) in 30 general practices in the Netherlands .


The primary outcome , the number of reported incidents , was measured with a questionnaire at baseline and a year after .


Analysis was performed using a negative binomial model .


Secondary outcomes were quality and safety indicators and safety culture .


Mixed effects linear regression was used to analyse the culture questionnaires .


The number of incidents increased in both intervention groups , to 82 and 224 in intervention I and II respectively .


Adjusted for baseline number of incidents , practice size and accreditation status , the study showed that practices that additionally participated in the workshop reported 42 ( 95 % confidence interval [ CI ] = 9.81 to 177.50 ) times more incidents compared to the control group .


Practices that only completed the questionnaire reported 5 ( 95 % CI = 1.17 to 25.49 ) times more incidents .


There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups .


Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents .


It is beneficial to invest in a team-wise effort to improve patient safety .


To compare outcomes between elective delivery at 37 weeks of pregnancy and expectant management among pregnant women with mild to moderate chronic hypertension .


In a two-center study , 76 women with mild to moderate chronic hypertension were randomly allocated to planned delivery at 37 completed weeks ( group A ) or expectant management for spontaneous onset of labor or reaching 41 weeks ( group B ) between April 2012 and October 2013 .


Differences were compared by t test , ( 2 ) test , or Fisher exact test .


Odds ratios ( ORs ) with 95 % confidence interval ( CIs ) were determined .


There were no differences in superimposed pre-eclampsia ( SPE ) , severe hypertension , preterm delivery , placental abruption , oligohydramnios , intrauterine growth restriction , or perinatal mortality between the groups .


Group B had higher gestational age at delivery ( P = 0.001 ) and birth weight ( P = 0.01 ) , but lower cesarean ( OR 3.4 ; 95 % CI , 1.2-10 .3 ; P = 0.03 ) and neonatal care unit admission ( OR 5.4 ; 95 % CI , 1.4-21 .0 ; P = 0.01 ) rates .


More women with SPE were diagnosed before than after 37 weeks in group B ( P = 0.01 ) .


Overall , patients who developed SPE had more adverse pregnancy outcomes than those who did not .


Mild to moderate chronic hypertension could be managed expectantly up to 41 weeks if SPE did not develop .


The study compared the transurethral resection in saline ( TURis ) , transurethral vaporization in saline ( TUVis ) , bipolar plasma enucleation of the prostate ( BPEP ) , and open prostatectomy ( OP ) in a single-center , prospective , randomized controlled clinical setting exclusively involving large prostate patients .


During a 4 year enrollment period , 320 cases of prostate volume over 80mL , maximum flow rate ( Qmax ) below 10mL/second , International Prostate Symptom Score ( IPSS ) over 19 , or urinary retention were included in the trial and equally randomized in the four study arms .


Patients were assessed preoperatively as well as at the 1 - , 3 - , 6 - , and 12-month follow-up checkups using the IPSS , quality of life ( QoL ) score , Qmax , postvoiding residual urinary volume ( PVR ) , and prostate-specific antigen ( PSA ) .


Similar preoperative parameters were established in the four series .


OP and BPEP were characterized by resembling operating times , while TURis and TUVis displayed prolonged surgical durations .


TURis emphasized a substantially decreased mean resected tissue weight .


TUVis showed the lowest mean hemoglobin level drop , followed by TURis and BPEP ( equivalent results ) and finally OP ( highest bleeding ) .


OP described the longest mean catheterization period and hospital stay , followed by TURis , and afterward by TUVis and BPEP ( similar data ) .


During the follow-up period , statistically equivalent IPSS , QoL , Qmax , and PVR outcomes were established for OP , BPEP , and TURis .


TUVis displayed significantly smaller Qmax improvements , but similar other functional features .


Significantly lower mean PSA levels were determined secondary to OP and BPEP when compared to bipolar resection and subsequently to vaporization .


OP and BPEP emphasized the highest surgical efficiency ( prolonged postoperative recovery for OP ) , while TUVis displayed the lowest hemorrhagic risks .


On the medium term , generally resembling functional outcomes were determined for the four techniques , with significantly decreased mean PSA values secondary to OP and BPEP .


To analyze discordance between global estimates by patients ( PATGL ) and their physicians ( DOCGL ) according to demographic and self-report variables on a Multidimensional Health Assessment Questionnaire ( MDHAQ ) in patients with many rheumatic diseases seen in usual care .


Each patient completed an MDHAQ at each visit , which includes scores for physical function , pain , and PATGL , each found on the traditional Health Assessment Questionnaire ( HAQ ) , and scores for sleep quality , anxiety , depression , self-report joint count , and fatigue , which are not found on the HAQ .


A random visit of 980 patients with any rheumatic diagnosis was analyzed in 3 categories : PATGL = DOCGL ( within 2 of 10 units ) , PATGL > DOCGL ( by 2 of 10 units ) , and DOCGL > PATGL ( by 2 of 10 units ) , using descriptive statistics and multinomial logistic regression models .


Patients included 145 with rheumatoid arthritis , 57 with systemic lupus erythematosus , 173 with osteoarthritis , 348 with other inflammatory diseases , and 257 with other noninflammatory diseases .


Overall , PATGL = DOCGL in 509 ( 52 % ) , PATGL > DOCGL in 371 ( 38 % ) , and DOCGL > PATGL in 100 ( 10 % ) .


PATGL > DOCGL was associated significantly with older age , female sex , low formal education , Hispanic ethnicity , not working , high MDHAQ physical function and pain scores , and high scores for fatigue , poor sleep , anxiety , depression , and self-report joint count , which are not available on the HAQ .


Pain and fatigue were significant in a final multinomial logistic regression ; the other variables may raise awareness of discordance to clinicians .


Global estimates of patients indicated significantly poorer status than estimates of their physicians in 38 % of 980 patients with rheumatic conditions , and were associated with demographic and MDHAQ scores , 5 of which are not available on the HAQ .


Evaluation of the performance of VIA ( visual inspection with acetic acid ) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable , hand-held colposcope ; the Gynocular , as compared to doctors .


A crossover randomised clinical trial .


The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University ( BSMMU ) , Dhaka , Bangladesh .


932 women attending the clinic as either screening nave for VIA screening ( 404 ) or women referred as VIA positive ( 528 ) from other VIA screening centres in the Dhaka region .


VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method .


The Swede score grade cervical acetowhiteness , margins plus surface .


vessel pattern , lesion size and iodine staining .


The women were randomised to start the examination by either a stationary colposcope or the Gynocular .


Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor .


Agreement between nurses and doctors in Swede scores was evaluated using the weighted statistic for the Gynocular and standard colposcope .


The ability to predict CIN 2 + ( CIN 2 , CIN 3 and invasive cervical cancer ) using Swede scores was evaluated using receiver-operating characteristic curves .


The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a statistic of 0.858 and 0.859 , respectively , and no difference in detecting cervical lesions in biopsy .


Biopsy detected CIN 2 + in 39 ( 4.2 % ) women .


Our study showed that VIA nurses can perform colposcopy .


There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system .


Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings .


ISRCTN53264564 .


Unhealthy weight loss practices are common among female college students .


It is unknown if these practices are also most common among women in the subset of overweight or obese college students or if these practices are related to depression .


We examined the relationship between gender , depression , and unhealthy weight loss practices among overweight or obese college students .


Students ( body mass index between 25.0 and 34.9 kg/m ( 2 ) ) from three Southern California universities ( M ( age ) = 22 years , SD = 4 ; 70 % women ) were recruited from May 2011 to May 2012 for participation in a weight loss clinical trial ( N = 404 ) .


Logistic regressions were performed with baseline data to assess the cross-sectional relationship between self-reported unhealthy weight loss practices and gender and depression as measured by the Center for Epidemiologic Studies Depression short form .


Twenty-nine percent of participants reported engaging in at least one unhealthy weight loss behavior ( e.g. , fasting , purging ) over the last 30 days , with no differences by gender .


Self-report of at least one unhealthy weight loss behavior was associated with report of symptoms of depression ( e ( B ) = 1.14 [ confidence interval , CI : 1.08-1 .20 ] ) , adjusting for potential confounders .


Interactions between gender and depression were not significant ( e ( B ) = 1.04 [ CI : 0.93-1 .16 ] ) .


Among an overweight or obese sample of college students , unhealthy weight loss practices were equally common in both genders , and students with depressive symptomatology were at greatest risk .


Obesity interventions targeting overweight or obese college students should educate both men and women about the dangers of unhealthy weight loss practices .


In addition , screening for depression can help identify students who would benefit from additional supportive and coping strategies and resources .


Provision of mother 's own milk is the optimal way to feed infants , including very low birth weight infants ( VLBW , < 1500 g ) .


Importantly for VLBW infants , who are at elevated risk of neurologic sequelae , mother 's own milk has been shown to enhance neurocognitive development .


Unfortunately , the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary .


Given the association between mother 's own milk and neurodevelopment , it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother 's own milk for 90 days or until hospital discharge , whichever comes first , will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development , 3 ( rd ) ed .


Secondary hypotheses are that the use of pasteurized donor milk will : ( 1 ) reduce a composite of death and serious morbidity ; ( 2 ) support growth ; and ( 3 ) improve language and motor development .


Exploratory research questions include : Will use of pasteurized donor milk : ( 1 ) influence feeding tolerance and nutrient intake ( 2 ) have an acceptable cost effectiveness from a comprehensive societal perspective ?


DoMINO is a multi-centre , intent-to-treat , double blinded , randomized control trial .


VLBW infants ( n = 363 ) were randomized within four days of birth to either ( 1 ) pasteurized donor milk or ( 2 ) preterm formula whenever mother 's own milk was unavailable .


Study recruitment began in October 2010 and was completed in December 2012 .


The 90 day feeding intervention is complete and long-term follow-up is underway .


Preterm birth and its complications are a leading cause long-term morbidity among Canadian children .


Strategies to mitigate this risk are urgently required .


As mother 's own milk has been shown to improve neurodevelopment , it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs .


Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond .


ISRCTN35317141 ; Registered 10 August 2010 .


To analyse late morbidity and mortality in pre and post-menopausal breast cancer patients treated with postmastectomy radiotherapy , with emphasis on side-effects from the heart , cerebrovascular and respiratory systems .


Long term follow-up of two randomised , clinical trials with 1100 patients was carried out .


Pre-menopausal women were allocated to radiotherapy ( RT ) , RT + oral cyclophosphamide ( RT+C ) or cyclophosphamide only ( C ) .


Post-menopausal women were allocated to RT , RT+T amoxifen for one year ( RT+T am ) or tamoxifen only ( Tam ) .


Information on admission to hospital , mortality and causes of death was obtained from national registers .


After 25 years , adding RT to cyclophosphamide in pre-menopausal women raised the mortality from heart disease from zero to 0.8 % ( p = 0.04 ) .


In post-menopausal women , adding RT to Tam raised the mortality from heart disease from 10.5 % to 18.4 % ( p = 0.005 ) .


In post-menopausal women mortality due to cerebrovascular disease increased from 3.4 % to 8.7 % by adding RT to Tam ( p = 0.015 ) .


The differences were not evident until in the second decade of follow-up .


In spite of differences in specific causes of death , there were no significant differences between the treatment arms concerning morbidity or overall mortality .


Postmastectomy radiotherapy to the chest wall and loco-regional lymph nodes including the parasternal lymph nodes as delivered in the end of the seventies did not reduce overall mortality , but gave a significantly increased risk of death from heart and cerebrovascular disease , which appeared during the second decade after radiotherapy .


Gemcitabine combined with carboplatin ( GC ) is a widely used regimen for advanced non-small cell lung cancer ( NSCLC ) , but clinical outcome is still hampered by its toxicity .


We conducted a randomized phase II study of GC and compared biweekly versus standard schedules in patients with advanced NSCLC with respect to toxicity and outcome .


Forty patients with stage IIIB or IV NSCLC were randomized to receive either a biweekly regimen of GC [ gemcitabine ( 1,000 mg/m ( 2 ) on days 1 and 14 ) and carboplatin ( area under the concentration-time curve , AUC = 3 on days 1 and 14 ) ] every 28 days or a standard regimen of GC [ gemcitabine ( 1,000 mg/m ( 2 ) on days 1 and 8 ) and carboplatin ( AUC = 5 on day 1 ) ] every 21 days .


These cycles were repeated until disease progression .


Response rates were 55 % for the biweekly regimen and 40 % for the standard regimen .


Median overall and progression-free survival times were 19.7 and 6.2 months , respectively , for the biweekly regimen , and 11.8 and 2.8 months , respectively , for the standard GC regimen .


Hematologic toxicity was prominent .


However , the incidence of grade 1 or 2 thrombocytopenia was significantly lower in the biweekly than in the standard GC regimen ( p < 0.05 ) .


Nonhematologic toxicity was mild .


A biweekly GC regimen was better tolerated than a standard GC regimen in patients with advanced NSCLC .


A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age .


We performed a multicenter , randomized , double-blind , placebo-controlled dietary-intervention study involving 944 children who were positive for HLA-DQ2 or HLA-DQ8 and had at least one first-degree relative with celiac disease .


From 16 to 24 weeks of age , 475 participants received 100 mg of immunologically active gluten daily , and 469 received placebo .


Anti-transglutaminase type 2 and antigliadin antibodies were periodically measured .


The primary outcome was the frequency of biopsy-confirmed celiac disease at 3 years of age .


Celiac disease was confirmed by means of biopsies in 77 children .


To avoid underestimation of the frequency of celiac disease , 3 additional children who received a diagnosis of celiac disease according to the 2012 European Society for Pediatric Gastroenterology , Hepatology , and Nutrition diagnostic criteria ( without having undergone biopsies ) were included in the analyses ( 80 children ; median age , 2.8 years ; 59 % were girls ) .


The cumulative incidence of celiac disease among patients 3 years of age was 5.2 % ( 95 % confidence interval [ CI ] , 3.6 to 6.8 ) , with similar rates in the gluten group and the placebo group ( 5.9 % [ 95 % CI , 3.7 to 8.1 ] and 4.5 % [ 95 % CI , 2.5 to 6.5 ] , respectively ; hazard ratio in the gluten group , 1.23 ; 95 % CI , 0.79 to 1.91 ) .


Rates of elevated levels of anti-transglutaminase type 2 and antigliadin antibodies were also similar in the two study groups ( 7.0 % [ 95 % CI , 4.7 to 9.4 ] in the gluten group and 5.7 % [ 95 % CI , 3.5 to 7.9 ] in the placebo group ; hazard ratio , 1.14 ; 95 % CI , 0.76 to 1.73 ) .


Breast-feeding , regardless of whether it was exclusive or whether it was ongoing during gluten introduction , did not significantly influence the development of celiac disease or the effect of the intervention .


As compared with placebo , the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of celiac disease by 3 years of age in this group of high-risk children .


( Funded by the European Commission and others ; PreventCD Current Controlled Trials number , ISRCTN74582487 . )


To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid ( HA ) gel for preventing intrauterine adhesion ( IUA ) after hysteroscopic adhesiolysis .


A prospective , randomized , double blinded and controlled clinical trial ( level I ) was performed .


According to American Fertility Society ( AFS ) scoring system , 120 patients ( treatment group : 60 cases , control group : 60 cases ) with moderate to severe IUA were enrolled .


Upon completion of adhesiolysis , a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group ; patients in the control group , however , only received Foley balloon catheter .


Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA .


Primary endpoint was the reduction rate of IUA at 3 months after surgery .


The secondary endpoints include total AFS score , score of each individual AFS category .


At 3 months after surgery , auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion , the effective rate were 76 % ( 42/55 ) and 48 % ( 27/56 ) respectively ( P = 0.000 9 ) ; the total AFS score of treatment group was 2.1 1.1 , and significantly lower than that of control group ( 3.7 2.5 , P = 0.000 8 ) .


Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern ( P = 0.037 8 , P = 0.000 4 ) .


The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [ 13 % ( 7/55 ) versus 38 % ( 21/56 ) , P = 0.000 6 ] .


No adverse events and complications were observed .


Auto-crosslinked HA gel coule be able to reduce IUA , decrease adhesion severity , and improve menopause postoperatively .


This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures .


Suicidal behaviour and deliberate self-harm are common among adults .


Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services can reduce reattempt risk .


Feasibility trials demonstrated that intervention through text message was also effective in preventing suicide repetition amongst suicide attempters .


The aim of the current study is to investigate the effect of text message intervention versus traditional treatment on reducing the risk of suicide attempt repetition among adults after self-harm .


The study will be a 2-year multicentric randomized controlled trial conducted by the Brest University Hospital , France .


Participants will be adults discharged after self-harm , from emergency services or after a short hospitalization .


Participants will be recruited over a 12-month period .


The intervention is comprised of an SMS that will be sent at h48 , D7 , D15 and monthly .


The text message enquires about the patients ' well-being and includes information regarding individual sources of help and evidence-based self help strategies .


Participants will be assessed at the baseline , month 6 and 13 .


As primary endpoint , we will assess the number of patients who reattempt suicide in each group at 6 months .


As secondary endpoints , we will assess the number of patients who reattempt suicide at 13 month , the number of suicide attempts in the intervention and control groups at 6 and 13 month , the number of death by suicide in the intervention and control groups at month 6 and 13 .


In both groups , suicidal ideations , will be assessed at the baseline , month 6 and 13 .


Medical costs and satisfaction will be assessed at month 13 .


This paper describes the design and deployment of a trial SIAM ; an easily reproducible intervention that aims to reduce suicide risk in adults after self-harm .


It utilizes several characteristics of interventions that have shown a significant reduction in the number of suicide reattempts .


We propose to assess its efficacy in reducing suicide reattempt in the suicide attempter ( SA ) population .


The study was registered on Clinical Trials Registry ( clinicaltrials.gov ) : NCT02106949 , registered on 06 June 2014 .


Stroke is a leading cause of death and disability internationally .


One of the three effective interventions in the acute phase of stroke care is thrombolytic therapy with tissue plasminogen activator ( tPA ) , if given within 4.5 hours of onset to appropriate cases of ischaemic stroke .


To test the effectiveness of a multi-component multidisciplinary collaborative approach compared to usual care as a strategy for increasing thrombolysis rates for all stroke patients at intervention hospitals , while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcomes for both groups at three months .


A cluster randomised controlled trial of 20 hospitals across 3 Australian states with 2 groups : multi - component multidisciplinary collaborative intervention as the experimental group and usual care as the control group .


The intervention is based on behavioural theory and analysis of the steps , roles and barriers relating to rapid assessment for thrombolysis eligibility ; it involves a comprehensive range of strategies addressing individual-level and system-level change at each site .


The primary outcome is the difference in tPA rates between the two groups post-intervention .


The secondary outcome is the proportion of tPA treated patients in both groups with good functional outcomes ( modified Rankin Score ( mRS < 2 ) and the proportion with intracranial haemorrhage ( mRS 2 ) , compared to international benchmarks .


TIPS will trial a comprehensive , multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites .


The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase .


Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not .


Australian New Zealand Clinical Trials Registry : ACTRN12613000939796 .


The purpose of the present study was to quantify perfusion to the femoral head and head-neck junction using gadolinium-enhanced magnetic resonance imaging following three surgical dislocations of the hip ( trochanteric flip osteotomy , standard posterior approach , and modified posterior approach ) .


The medial femoral circumflex artery was cannulated in fifty fresh-frozen cadaveric hips ( twenty-five pelvic specimens ) .


One hip on each pelvic specimen was randomly chosen to undergo one of the three surgical dislocations , and the contralateral hip was used as a control .


Gadolinium enhancement on the magnetic resonance imaging scan was quantified in both the femoral head and head-neck junction by volumetric analysis using custom magnetic resonance imaging analysis software .


A polyurethane compound was then injected , and gross dissection was performed to assess the extraosseous vasculature .


Magnetic resonance imaging quantification revealed that the trochanteric flip osteotomy group maintained almost full perfusion ( mean , 96 % for the femoral head and 98 % for the head-neck junction ) .


The standard posterior approach almost completely compromised perfusion ( mean , 4 % for the femoral head and 8 % for the head-neck junction ) .


Six specimens in the modified posterior approach group demonstrated partial perfusion ( mean , 32 % in the femoral head and 26 % in the head-neck junction ) .


Three specimens in the modified posterior approach group demonstrated almost full perfusion ( mean , 96 % in the femoral head and 97 % in the head-neck junction ) .


Gross dissection revealed that all specimens in the standard posterior approach group and seven of ten in the modified posterior approach group sustained disruption of the ascending branch of the medial femoral circumflex artery .


All specimens in the standard posterior approach group demonstrated disruption of the inferior retinacular artery .


The inferior retinacular artery remained intact in nine of ten specimens in the modified posterior approach group .


One specimen in the modified posterior approach group that had disruption of both the ascending medial femoral circumflex artery and inferior retinacular artery demonstrated a substantial decrease in perfusion ( 7 % in the femoral head and 5 % in the head-neck junction ) .


The trochanteric flip osteotomy preserves the vascular supply to the femoral head and head-neck junction .


The standard posterior approach disrupts the vascular supply and should be completely abandoned for surgical hip dislocation .


Despite reduced enhancement , substantial perfusion of the femoral head and head-neck junction was present in the modified posterior approach group , likely because of the preservation of the inferior retinacular artery .


The modified posterior approach produced variable results , indicating that improvement to the modified posterior approach is needed .


Our study provides previously unreported quantitative magnetic resonance imaging data on the perfusion to the femoral head and head-neck junction during common surgical approaches to the hip .


Whole genome sequencing ( WGS ) is already being used in certain clinical and research settings , but its impact on patient well-being , health-care utilization , and clinical decision-making remains largely unstudied .


It is also unknown how best to communicate sequencing results to physicians and patients to improve health .


We describe the design of the MedSeq Project : the first randomized trials of WGS in clinical care .


This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts : ( a ) disease-specific genomic medicine in a cardiomyopathy clinic and ( b ) general genomic medicine in primary care .


We are recruiting 8 to 12 cardiologists , 8 to 12 primary care physicians , and approximately 200 of their patients .


Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS .


Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity .


We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients ' genome reports .


Using varied data sources , including surveys , semi-structured interviews , and review of clinical data , we measure the attitudes , behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results .


The impact of emerging sequencing technologies on patient care is unclear .


We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future .


That is , our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and , through physicians , to their patients .


This project will not only illuminate the impact of integrating genomic medicine into the clinical care of patients but also inform the design of future studies .


ClinicalTrials.gov identifier NCT01736566 .


It is unknown whether leptin and peptide YY ( PYY ) influence changes in resting energy expenditure ( REE ) , independently of fat mass ( FM ) and fat-free mass ( FFM ) in addition to changes in other energy expenditure ( EE ) components during weight loss .


The objective of the study was to examine the relationships between leptin , PYY , and body composition with different EE components before and after weight loss and whether changes in leptin and PYY were associated with differences in predicted vs measured REE after the intervention .


This was a randomized controlled design .


The study was conducted in a laboratory .


Participants were ninety-three overweight/obese postmenopausal women ( aged 58.1 4.8 y ; body mass index 32.1 4.3 kg/m ( 2 ) ) .


Interventions included a 6-month caloric restriction diet alone or caloric restriction diet + resistance training .


Body composition ( dual energy x-ray absorptiometry ) , REE ( indirect calorimetry ) , total EE ( TEE ; doubly labeled water ) , and fasting leptin and total PYY before and after weight loss were measured .


Both interventions yielded significant decreases in weight , FFM , REE , and leptin , whereas a significant time group interaction was noted for FM ( greater decrease in FM in the diet + resistance training group ) ( P < .05 for all outcomes ) .


No significant differences in TEE , physical activity EE , and PYY were noted between baseline and after the intervention .


Age , FFM , leptin , and PYY were the best predictors of baseline REE ( R ( 2 ) = 0.77 ; P = .0001 ) , whereas age , FFM , and FM were associated with REE after the intervention ( R ( 2 ) = 0.88 ; P = .0001 ) .


The same predictors , except for leptin , were significantly related to TEE at baseline ( R ( 2 ) = 0.70 ; P = .0001 ) and after the intervention ( R ( 2 ) = 0.29 ; P = .0001 ) , whereas only PYY was a significant predictor of physical activity EE at baseline and after the intervention .


Changes in FM and leptin accounted for 27 % of the variance in REE ( P = .0001 ) .


Greater predicted vs measured REE was noted after the intervention ( P = .02 ) .


However , leptin and PYY were not significant predictors of the differences between postintervention measurement and predicted REE .


Leptin and FM were strong contributors to changes in REE .


However , leptin and PYY were not significant predictors of the differences between predicted and measured REE after the intervention .


To evaluate the influence of epidural analgesia and lumbar paravertebral block on the structure of the delivery , the fetus and newborn , and the quality and duration of analgesia .


Patients were randomized into three groups , 30 patients in each group .


In the group-1 patients received epidural analgesia ( EA ) , in the group-2 -- paravertebral block ( PVB ) , in the group-3 patients refused pain relief in labor .


Pain was assessed by VAS .


Length of the first and second stage of labor the impact on the CTG and fetal blood gases from the umbilical cord of newborns in the first minute of life were fixed .


Data were analyzed by Mann-Whitney U test and presented as median ( 25th-75th percentiles ) .


In both groups of patients in pain reduction was significant adjustment contractions and after 1 hour was 94.5 % in EA , and PVB group -- 78.7 % of the initial values .


Under EA opening cervix was statistically significantly greater than in the PVB ( 192.5 ( 145 , 302 ) vs 172.5 ( 112 , 210 ) min ) p < 0.05 .


Second stage of labor was also shorter in the PVB than in the EA ( 30.4 ( 10.2 , 46.5 ) vs 59.8 ( 40.2 , 81.5 ) min ) , in the control group it was -- 40.6 ( 21.3 , 55.4 ) min , p < 0.05 .


PVB was observed in the group of more stable hemodynamics than in the EA for the entire period of observation .


There were no adverse effects on the fetus and the newborn in the arms of the study .


The proposed lumbar paravertebral block is simple to perform , is effective in reducing pain in the first stage of labor does not require continuous hemodynamic monitoring may be used for the treatment of birth dystocia and is a good alternative when the use of epidural analgesia during labor is limited .


To study the effect on maternal weight gain of a supervised light - to moderate-intensity exercise-based intervention performed from the ninth week of pregnancy .


A total of 962 healthy pregnant women were randomly assigned to a standard care or exercise intervention group conducted between September 1 , 2007 , and January 31 , 2011 .


The intervention included light - to moderate-intensity aerobic and resistance exercises performed 3 days a week ( 50-55 minutes per session ) .


Excessive gestational weight gain was calculated on the basis of the 2009 Institute of Medicine ( IOM ) recommendations .


Gestational body weight gain was calculated on the basis of the weight measured at the first prenatal visit ( fifth to sixth weeks of gestation ) and weight measured at the last visit to the clinic before delivery .


Women were categorized into normal weight or overweight or obese .


Women in the intervention group gained less weight ( adjusted mean difference , 1.039 kg ; 95 % CI , 0.534-1 .545 kg ; P < .001 ) and were less likely to gain weight above the IOM recommendations ( odds ratio , 0.625 ; 95 % CI , 0.461-0 .847 ) compared with those in the standard care group .


The main treatment effects according to body mass index category were that normal weight women in the intervention group gained less weight ( adjusted mean difference , 1.393 kg ; 95 % CI , 0.813-1 .972 kg ; P < .001 ) and were less likely to gain weight above the IOM recommendations ( odds ratio , 0.508 ; 95 % CI , 0.334-0 .774 ) than normal weight women who received standard care .


No significant treatment effect was observed in overweight or obese women .


Supervised exercise of light to moderate intensity can be used to prevent excessive gestational weight gain , especially in normal weight women .


clinicaltrials.gov Identifier : NCT01790347 .


Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement .


However , there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission .


We investigated the effect of intermittent screening and treatment ( IST ) for malaria on the health and education of school children in an area of low to moderate malaria transmission .


A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012 .


The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months .


Once a school term , children were screened by public health workers using malaria rapid diagnostic tests ( RDTs ) , and children ( with or without malaria symptoms ) found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine ( AL ) .


Given the nature of the intervention , the trial was not blinded .


The primary outcomes were anaemia and sustained attention .


Secondary outcomes were malaria parasitaemia and educational achievement .


Data were analysed on an intention-to-treat basis .


During the intervention period , an average of 88.3 % children in intervention schools were screened at each round , of whom 17.5 % were RDT-positive .


80.3 % of children in the control and 80.2 % in the intervention group were followed-up at 24 months .


No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months ( adjusted risk ratio [ Adj.RR ] : 1.03 , 95 % CI 0.93-1 .13 , p = 0.621 and Adj.RR : 1.00 , 95 % CI 0.90-1 .11 , p = 0.953 ) respectively , or on prevalence of P. falciparum infection or scores of classroom attention .


No effect of IST was observed on educational achievement in the older class , but an apparent negative effect was seen on spelling scores in the younger class at 9 and 24 months and on arithmetic scores at 24 months .


In this setting in Kenya , IST as implemented in this study is not effective in improving the health or education of school children .


Possible reasons for the absence of an impact are the marked geographical heterogeneity in transmission , the rapid rate of reinfection following AL treatment , the variable reliability of RDTs , and the relative contribution of malaria to the aetiology of anaemia in this setting .


www.ClinicalTrials.gov NCT00878007 .


This study intended to implement a novel intervention strategy , in Brazil , using an ecohealth approach and analyse its effectiveness and costs in reducing Aedes aegypti vector density as well as its acceptance , feasibility and sustainability .


The intervention was conducted from 2012 to 2013 in the municipality of Fortaleza , northeast Brazil .


A cluster randomized controlled trial was designed by comparing ten intervention clusters with ten control clusters where routine vector control activities were conducted .


The intervention included : community workshops ; community involvement in clean-up campaigns ; covering the elevated containers and in-house rubbish disposal without larviciding ; mobilization of schoolchildren and senior inhabitants ; and distribution of information , education and communication ( IEC ) materials in the community .


Differences in terms of social participation , commitment and leadership were present in the clusters .


The results showed the effectiveness of the intervention package in comparison with the routine control programme .


Differences regarding the costs of the intervention were reasonable and could be adopted by public health services .


Embedding social participation and environmental management for improved dengue vector control was feasible and significantly reduced vector densities .


Such a participatory ecohealth approach offers a promising alternative to routine vector control measures .


To evaluate the effect of olmesartan medoxomil tablets ( olmesartan ) in comparison with Olmetec on 24 h ambulatory blood pressure ( ABPM ) and blood pressure variability ( BPV ) in patients with mild to moderate hypertension .


A randomized , double-blind , double-mimic controlled trial was performed.Forty-eight patients with mild to moderate essential hypertension were randomly into treatment group ( olmesartan ) and control group ( Olmetec ) for eight weeks .


The ABPM was taken before and at the end of the trial .


After eight weeks , treatment with olmesartan induced a significant reduction in ABPM in patients [ ( 9 3 ) / ( 11 3 ) mmHg ( 1 mmHg = 0.133 kPa ) ] , which is similar with the reduction by Olmetec [ ( 9 4 ) / ( 9 5 ) mmHg ] , P > 0.05 .


This situation holds for BPV with the standard deviations of 24 h , systolic blood pressure/diastolic blood pressure of pre-treatment and pro-treatment were ( 10 2 ) / ( 11 3 ) mmHg vs ( 10 3 ) / ( 12 2 ) mmHg in olmesartan group , and ( 10 3 ) / ( 11 3 ) mmHg vs ( 12 3 ) / ( 12 4 ) mmHg in Olmetec group .


( 3 ) There is no difference in the rate of adverse event between olmesartan ( 10.42 % ) and Olmetec ( 8.33 % ) treatment ( P > 0.05 ) .


Similar to Olmetec , treatment with olmesartan once daily can significantly reduce ABPM in patients with mild to moderate essential hypertension .


The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction ( HFSR ) on the soles of the feet in metastatic renal cell carcinoma ( RCC ) patients treated with sorafenib .


Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups .


One group received a hydrocolloid dressing containing ceramide ( arm A ) and the other received 10 % urea cream ( arm B ) .


Patients in both groups applied treatment to the affected sites on the soles of the feet , but not to the hands .


The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks .


Thirty-three patients were assessed ( 17 in arm A and 16 in arm B ) , and there were no significant differences in baseline characteristics between the two groups .


During the observation period of this study , grade 2 or 3 HFSR on the soles of the feet was found in 29 % of patients in arm A and was significantly less than the 69 % in arm B ( P = 0.03 ) .


The incidence of HFSR on the hands , however , was similar in both arms .


The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B ( P = 0.03 ) .


These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients .


UMIN000002016 .


Spinal cord injury ( SCI ) leads to a profound muscular atrophy , bone loss and bone fragility .


While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI , there is little evidence that exercise can prevent muscle changes early after injury .


Moreover , whether exercise can prevent bone loss and microarchitectural decay is not clear .


A multi-centre , parallel group , assessor-blinded randomised controlled trial will be conducted .


Fifty participants with acute spinal cord injury will be recruited from four SCI units in Australia and New Zealand .


Participants will be stratified by site and AIS status and randomised to an experimental or control group .


Experimental participants will receive a 12-week programme of functional electrical stimulation ( FES ) - assisted cycling .


Control participants will receive a 12-week programme of passive cycling .


The primary outcome is muscle cross-sectional area of the thigh and calf measured using magnetic resonance images ( MRI ) of the leg .


Secondary outcomes include serum biomarkers of SCI osteoporosis ( sclerostin , P1NP and - CTX ) , markers of immune function ( IL-6 , IL-10 , FGF2 , INF - , TNF - ) , neurological function , body composition , depression and quality of life .


Leg MRIs will be measured by a single blinded assessor based in Melbourne .


Serum samples will be analysed in a central laboratory .


All other characteristics will be measured at baseline and 12weeks by blinded and trained assessors at each site .


The first participant was randomised on 27 November 2012 .


The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury .


ACTRN12611001079932 ( 18 October 2011 ) .


Hospitalization for acute heart failure ( HF ) is associated with high rates of subsequent mortality and readmission .


We assessed the influence of the time interval between previous HF hospitalization and randomization in the Candesartan in Heart failure : Reduction in Mortality and morbidity ( CHARM ) trials on clinical outcomes in patients with both reduced and preserved ejection fraction .


CHARM enrolled 7599 patients with New York Heart Association class II to IV HF , of whom 5426 had a history of previous HF hospitalization .


Cox proportional hazards regression models were used to assess the association between time from previous HF hospitalization and randomization and the primary outcome of cardiovascular death or unplanned admission to hospital for the management of worsening HF during a median of 36.6 months .


For patients with HF and reduced or preserved ejection fraction , rates of cardiovascular mortality and HF hospitalization were higher among patients with previous HF hospitalization than those without .


The risk for mortality and hospitalization varied inversely with the time interval between hospitalization and randomization .


Rates were higher for patients with HF and reduced ejection fraction within each category .


Event rates for those with HF with preserved ejection fraction and a HF hospitalization in the 6 months before randomization were comparable with the rate in patients with HF and reduced ejection fraction with no previous HF hospitalization .


Rates of cardiovascular death or HF hospitalization are greatest in those who have been previously hospitalized for HF .


Independent of EF , rates of death and readmission decline as time from HF hospitalization to trial enrollment increased .


Recent HF hospitalization identifies a high-risk population for future clinical trials in HF and reduced ejection fraction and HF with preserved ejection fraction .


http://www.clinicaltrials.gov .


Unique identifier : NCT00634400 .


To study whether Johan Sebastian Bach music has a lowering effect on resting energy expenditure ( REE ) similar to that of Wolfgang Amadeus Mozart music .


Prospective , randomized clinical trial with cross-over in 12 healthy , appropriate weights for gestational age ( GA ) , gavage fed , metabolically stable , preterm infants .


Infants were randomized to a 30-min period of either Mozart or Bach music or no music over 3 consecutive days .


REE was measured every minute by indirect calorimetry .


Three REE measurements were performed in each of 12 infants at age 2015.8 days .


Mean GA was 30.172.44 weeks and mean birthweight was 1246239g .


REE was similar during the first 10-min of all three randomization periods .


During the next 10-min period , infants exposed to music by Mozart had a trend toward lower REE than when not exposed to music .


This trend became significant during the third 10-min period .


In contrast , music by Bach or no music did not affect significantly REE during the whole study .


On average , the effect size of Mozart music upon REE was a reduction of 7.7 % from baseline .


Mozart music significantly lowers REE in preterm infants , whereas Bach music has no similar effect .


We speculate that ` Mozart effect ' must be taken into account when incorporating music in the therapy of preterm infants , as not all types of music may have similar effects upon REE and growth .


Seroma formation is the most frequent postoperative complication after axillary dissection for breast surgery with an incidence of 10 - 50 % .


This prospective clinical randomized study was carried out to evaluate the Ligasure vessel sealing system and its effect on seromaformation and other complications for axillary dissection .


Between January 2006 and November 2007 , the patients with histopathological diagnosis of breast cancer were analysed prospectively .


The patients with positive sentinel lymph node biopsy or clinical axillary involvement were included in the study , and the patients who underwent neoadjuvant therapy or using anticoagulants have been excluded from the study .


Patients were divided into two study groups.Axillary dissection was performed in the first group by LigaSure and in the second group by linking and electrocautery .


There were a total of thirty three patients with a mean age of 51.4 + - 13.7 .


In group one , mean age of patients was 54.1 + - 13.2 and 48.68 + - 14.1 in group two .


There was no significant statistical difference between the groups regarding age , body mass index , excised tissue weight , tumour size and number of excised lymph nodes .


The use of Ligasure reduced drainage amount and duration of drain till removal , but increased operative time .


There were no significant differences between study groups regarding the complications .


LigaSure electrothermal bipolar vessel sealing system can be safely used in axillary dissection as an alternative to traditional methods .


To evaluate whether couples with moderate male infertility should be treated with conventional in vitro fertilization ( IVF ) or intracytoplasmic sperm injection ( ICSI ) .


A total of 249 couples with moderate male infertility undergoing their first IVF/ICSI cycle were enrolled in the study .


The couples were divided into two groups according to the results of semen analysis : moderate oligozoospermia ( O group ) and moderate oligoasthenozoospermia ( OA group ) .


Sibling oocytes were randomized into groups to be inseminated either by conventional IVF or ICSI .


Fertilization rate , embryo quality , implantation rate , and clinical pregnancy rate were examined .


There was no difference in the fertilization , implantation , and pregnancy rates between conventional IVF and ICSI in either the O group or OA group ( p > 0.05 ) .


Additionally , in the OA group , the good quality embryo rate was similar after IVF or ICSI ( p > 0.05 ) .


However , in the O group , the good quality embryo rate was significantly higher after ICSI than after IVF ( p < 0.05 ) .


Couples with moderate oligozoospermia or moderate oligoasthenozoospermia did not influence the major indices of IVF .


Because of the uncertainties concerning the safety of ICSI , couples with moderate oligozoospermia or moderate oligoasthenozoospermia need not be subjected to this procedure .


Venous thromboembolism may be the earliest sign of cancer .


Currently , there is a great diversity in practices regarding screening for occult cancer in a person who has an unprovoked venous thromboembolism .


We sought to assess the efficacy of a screening strategy for occult cancer that included comprehensive computed tomography ( CT ) of the abdomen and pelvis in patients who had a first unprovoked venous thromboembolism .


We conducted a multicenter , open-label , randomized , controlled trial in Canada .


Patients were randomly assigned to undergo limited occult-cancer screening ( basic blood testing , chest radiography , and screening for breast , cervical , and prostate cancer ) or limited occult-cancer screening in combination with CT. .


The primary outcome measure was confirmed cancer that was missed by the screening strategy and detected by the end of the 1-year follow-up period .


Of the 854 patients who underwent randomization , 33 ( 3.9 % ) had a new diagnosis of occult cancer between randomization and the 1-year follow-up : 14 of the 431 patients ( 3.2 % ) in the limited-screening group and 19 of the 423 patients ( 4.5 % ) in the limited-screening-plus-CT group ( P = 0.28 ) .


In the primary outcome analysis , 4 occult cancers ( 29 % ) were missed by the limited screening strategy , whereas 5 ( 26 % ) were missed by the strategy of limited screening plus CT ( P = 1.0 ) .


There was no significant difference between the two study groups in the mean time to a cancer diagnosis ( 4.2 months in the limited-screening group and 4.0 months in the limited-screening-plus-CT group , P = 0.88 ) or in cancer-related mortality ( 1.4 % and 0.9 % , P = 0.75 ) .


The prevalence of occult cancer was low among patients with a first unprovoked venous thromboembolism .


Routine screening with CT of the abdomen and pelvis did not provide a clinically significant benefit .


( Funded by the Heart and Stroke Foundation of Canada ; SOME ClinicalTrials.gov number , NCT00773448 . )


Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing .


We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer ( Orsiro , O-SES ) compared with the durable polymer Xience Prime everolimus-eluting stent ( X-EES ) in terms of the primary end point in-stent late lumen loss at 9 months .


A total of 452 patients were randomly assigned 2:1 to treatment with O-SES ( 298 patients , 332 lesions ) or X-EES ( 154 patients , 173 lesions ) in a multicenter , noninferiority trial .


The primary end point was in-stent late loss at 9 months .


O-SES was noninferior to X-EES for the primary end point ( 0.100.32 versus 0.110.29 mm ; difference = 0.00063 mm ; 95 % confidence interval , -0.06 to 0.07 ; Pnoninferiority < 0.0001 ) .


Clinical outcome showed similar rates of target-lesion failure at 1 year ( O-SES 6.5 % versus X-EES 8.0 % ; hazard ratio = 0.82 ; 95 % confidence interval , 0.40-1 .68 ; log-rank test : P = 0.58 ) without cases of stent thrombosis .


A subgroup of patients ( n = 55 ) underwent serial optical coherence tomography at 9 months , which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES ( 0.100.04 mm versus 0.110.04 mm ; -0.01 [ -0.04 , -0.01 ] ; P = 0.37 ) .


Another subgroup of patients ( n = 56 ) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up ( O-SES , 0.160.33 mm ( 2 ) versus X-EES , 0.430.56 mm ( 2 ) ; P = 0.04 ) .


Compared with durable polymer X-EES , novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months .


Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up .


http://www.clinicaltrials.gov .


Unique identifier : NCT01356888 .


To observe the sensitivity of stroke volume variation ( SVV ) for assessing volume change during induction period of general anesthesia .


Patients who underwent orthopaedic surgery under general anesthesia and mechanical ventilation were divided into two groups randomly .


Patients in the group were subjected to progressive central hypovolemia and correction of hypovolemia sequentially ; patients in the Group were exposed to hypervolemia alone .


Each step was implemented after 5 minutes when the hemodynamics was stable .


SVV and cardiac index ( CI ) were recorded , and Pearson 's product-moment correlation was used to analyze correlation between SVV and CI .


Forty patients were included in this study , 20 cases in each group .


For group patients , SVV was increased significantly along with blood volume reduction , and changes in CI were negatively correlated with changes in SVV ( r = -0.605 , P < 0.01 ) ; SVV decreased significantly along with correction of blood volume ; changes in CI were negatively correlated with changes in SVV ( r = -0.651 , P < 0.01 ) .


For group patients , along with blood volume increase , SVV did not change significantly ; changes in CI revealed no significant correlation with changes in SVV ( r = 0.067 , P > 0.05 ) .


SVV is a useful indicator for hypovolemia , but not for hypervolemia .


In guided tissue regenerative surgery , membrane perforations may serve as a mechanism for the passage of cells and biologic mediators from the periosteum and overlying gingival connective tissue into the periodontal defects .


To test this assumption , this study was designed to evaluate levels of bone morphogenetic protein-2 ( BMP-2 ) in gingival crevicular fluid ( GCF ) during the early stages of healing for sites treated with modified perforated membranes ( MPMs ) as compared with occlusive membranes ( OMs ) .


Fifteen non-smoking patients with severe chronic periodontitis participated in this prospective , randomized and single-blinded clinical trial .


Each patient contributed two interproximal contralateral defects that were randomly assigned to either an experimental modified perforated membrane group ( 15 sites ) or a control occlusive membrane group ( 15 sites ) .


Plaque index , gingival index , probing depth ( PD ) , clinical attachment level ( CAL ) and the relative intrabony depth of the defect ( rIBD ) were measured at baseline and reassessed at three , six and nine months after therapy .


Gingival crevicular fluid samples were collected on day 1 and 3 , 7 , 14 , 21 , and 30 days after therapy .


The MPM-treated group showed a statistically significant improvement in PD reduction and clinical attachment gain compared to the OM control group .


Similarly , rIBD was significantly reduced in MPM-treated sites as compared with those of the OM group .


BMP-2 concentrations peaked in the MPM samples obtained during the early postoperative period ( days 1 , 3 and 7 ) with a statistically significant difference compared with OM-treated groups .


BMP-2 levels decreased sharply in the samples obtained at days 14 , 21 and 30 with non-significant higher levels in MPM samples as compared with those of OM sites .


Within the limits of the present study , one can conclude that MPM coverage of periodontal defects is associated with a significant initial increase in GCF levels of BMP-2 , a factor that could improve the clinical outcomes of guided tissue regenerative surgery .


The protective effects of volatile anaesthetics against ischaemia-reperfusion injury have been shown in vitro , but clinical studies have yielded variable results .


We hypothesized that , in children , sevoflurane provides superior cardioprotection after cardiac surgery on cardiopulmonary bypass ( CPB ) compared with totally intravenous anaesthesia ( TIVA ) .


In this randomized controlled , single-centre study , 60 children with cyanotic and acyanotic heart defects undergoing elective cardiac surgery under CPB ( RACHS-1 1-3 ) were randomized to sevoflurane or TIVA ( midazolam < 6 months of age , propofol > 6 months of age ) .


The primary end-point was the postoperative peak cardiac troponin I/T ( cTnI/T ) .


Perioperative cardiac function ( as determined by brain-type natriuretic peptide , echocardiography and postoperative vasopressor/inotrope requirements ) , short-term clinical outcomes ( duration of intubation , intensive care unit and hospital length of stay ) , postoperative inflammatory profile , and pulmonary , renal and liver function were defined as secondary end-points .


Analysis of variance was used for statistical analysis .


There was no statistically significant difference in postoperative peak troponin values or any of the secondary end-points .


In the subgroup of acyanotic patients under 6 months , sevoflurane led to significantly lower postoperative troponin levels compared with midazolam [ reduction of 54 % ( 95 % confidence interval 29-71 % , P = 0.002 ) ] , without any differences in secondary outcome parameters .


Sevoflurane did not provide superior myocardial protection in our general paediatric cardiac surgical population .


In children under 6 months , however , sevoflurane might be beneficial in comparison with midazolam .


The conditioning effects of sevoflurane in specific paediatric subgroups need to be further investigated .


To evaluate the efficacy of a Social Cognitive Theory-based Internet intervention designed to promote and maintain leisure-time physical activity in university-aged female students in Thailand .


The 3-month intervention was delivered through a website and e-mails with a follow-up evaluation 3 months after the end of the intervention .


Female students ( N = 220 ) were allocated to 4 parallel groups .


Significant increases in steps / day , weekly leisure-time activity score , self-efficacy , outcome expectations , and self-regulation , and reduced resting heart rate were observed at the end of the intervention .


With the exception of resting heart rate , the intervention effects on these variables also remained at the follow-up .


The Internet intervention program was effective in promoting and maintaining leisure-time physical activity in university-aged female students .


It remains unclear whether analgesia from intraperitoneal local anesthetics is via local or central mechanisms .


This double-blind clinical trial tests the hypothesis that intraperitoneal local anesthetic is superior to continuous IV infusion for pain management .


Primary outcome was morphine consumption during 0 to 24 h.


Informed consent was obtained from 60 patients , age 30 to 75 yr , American Society of Anesthesiologists physical status I to II , undergoing abdominal hysterectomy .


A computer-generated program randomized patients in parallel arms to group IV : continuous infusion of lidocaine 50 mg/h ( 10 ml ) IV and saline 10 ml/h intermittently intraperitoneal ; group IP : injection of lidocaine 50 mg/h ( 10 ml ) once every hour intraperitoneally and continuous infusion of saline 10 ml/h intravenously ; and group P ( placebo ) : saline 10 ml/h both intravenously and intermittent intraperitoneal injection .


Postoperative morphine consumption , pain intensity , recovery , home discharge , and lidocaine concentrations were measured .


Morphine consumption during 0 to 24 h was lower in group IP versus group IV , mean difference -22.6 mg ( 95 % CI , 11.4 to 33.8 ; P < 0.01 ) .


No difference was seen between group IV and group P.


The total mean plasma concentration of lidocaine in group IP was significantly lower than group IV , 0 to 4.5 h postoperatively ( P = 0.03 ) with no evidence of systemic toxicity .


Pain intensity and other recovery parameters were similar between the groups .


The lower supplemental morphine consumption and plasma lidocaine concentration in group IP would confirm that the effects of local anesthetics are likely to be predominant via local intraperitoneal receptors or anti-inflammatory effects and not via central mechanisms alone .


To explore the effects of warm needling combined with Zhangmo decoction ( see text ) on endometrial receptivity in patients with clomiphene ( CC ) - induced ovulation .


One hundred and sixty cases were randomly divided into a CC group ( group A ) , a CC + progynova group ( group B ) , a CC + Zhangmo decoction group ( group C ) and a CC + Zhangmo decoction + warm needling group ( group D ) , 40 cases in each one .


In the Group A , CC alone was applied .


In the group B , progynova was jointly used on the 8th day of menstrual cycle .


In the Group C , Zhangmo decoction was jointly used on the 5th day of menstrual cycle .


In the group D , based on treatment of the Zhangmo decoction , warm needling was applied at Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) and Zigong ( EX-CA 1 ) etc. .


The endometrial thickness and type , pulsatility index ( PI ) , resistance index ( RI ) , ratio of S/D on day of human chorionic gonadotropin ( HCG ) and pregnancy rate were observed in fou groups .


The PI , RI and S/D in the group C and D were obviously lower than those in group A and B ( all P < 0.01 ) .


The endometrial thickness was ( 7.7 + / - 1.49 ) mm in group B , ( 8.2 + / - 1.54 ) mm in group C and ( 8.9 + / - 1.51 ) mm in group D , which were significantly different from ( 6.4 5 + / - 1.26 ) mm in the group A ( all P < 0.01 ) also there was a significant difference between group C and D ( P < 0.05 ) .


The rate of endometrial type A was 65.0 % in the group D , which was significantly higer than 27.5 % in the group A , 32.5 % in the group B and 35.0 % in the group C ( all P < 0.01 ) .


The pregnancy rate was 30.0 % in the group D , which was obviously higher than 12.5 % in the group A , 15.0 % in the group B and 17.5 % in the group C ( P < 0.05 ) .


The endometrial thickness and rate of endometrial type A in the pregnant were obviously higher than those in the non-pregnant ( both P < 0.01 ) while PI , RI and S/D was lower than those in the non-pregnant ( P < 0.01 , P < 0.05 ) .


Warm needing combined with Zhangmo decoction could improve endometrial thickness , morphology and uterine spiral artery to improve pregnancy rate , which has superior effect to clomiphene , clomiphene combined with progynova and clomiphene combined with Zhangmo decoction .


Despite their high prevalence in daily life , repeated night-wakings and their cognitive and emotional consequences have received less research attention compared to other types of sleep disturbances .


Our aim was to experimentally compare the effects of one night of induced infrequent night-wakings ( of 15 min , each requiring a purposeful response ) and sleep restriction on sustained attention and mood in young adults .


In a within-between subjects counterbalanced design , 61 healthy adults ( 40 females ; aged 20-29 years ) underwent home assessments of sustained attention and self-reported mood at two times : after a normal ( control ) sleep night , and after a night of either sleep restriction ( 4h in bed ) or induced night-wakings ( four prolonged awakenings across 8h in bed ) .


Sleep was monitored using actigraphy and sleep diaries .


Sustained attention was assessed using an online continuous performance test ( OCPT ) , and mood was reported online using the Profile of Mood States ( POMS ) .


Actigraphic data revealed good compliance with experimental sleep requirements .


Induced night-wakings and sleep restriction both resulted in more OCPT omission and commission errors , and in increased depression , fatigue and confusion levels and reduced vigor compared to the normal sleep night .


Moreover , there were no significant differences between the consequences of induced awakenings and sleep restriction .


Our pilot study indicates that , similar to sleep restriction , one night of life-like repeated night-wakings negatively affects mood and sustained attention .


Low back pain affects approximately 80 % of people at some stage in their lives .


Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines .


Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life .


However , the efficacy of whole body vibration exercise for low back pain is not without dispute .


This study aims to estimate the effect of whole body vibration exercise for chronic low back pain .


We will conduct a prospective , single-blind , randomized controlled trial of 120 patients with chronic low back pain .


Patients will be randomly assigned into an intervention group and a control group .


The intervention group will participate in whole body vibration exercise twice a week for 3 months .


The control group will receive general exercise twice a week for 3 months .


Primary outcome measures will be the visual analog scale for pain , the Oswestry Disability Index and adverse events .


The secondary outcome measures will include muscle strength and endurance of spine , trunk proprioception , transversus abdominis activation capacity , and quality of life .


We will conduct intention-to-treat analysis if any participants withdraw from the trial .


Important features of this study include the randomization procedures , single-blind , large sample size , and a standardized protocol for whole body vibration in chronic low back pain .


This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain .


Therefore , our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers .


Chinese Clinical Trial Registry : ChiCTR-TRC-13003708 .


To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis ( MS ) .


Secondary analysis of data from a randomized controlled trial .


University research laboratory .


Ambulatory persons with MS ( N = 82 ) .


A 6-month , internet-delivered physical activity behavioral intervention designed to increase lifestyle physical activity , primarily walking .


The behavioral intervention was based on principles of social cognitive theory .


Whole-body bone mineral content ( BMC ) , bone mineral density ( BMD ) , and soft tissue composition , using dual-energy x-ray absorptiometry .


There were no significant differences between conditions posttrial on body composition outcomes using the adjusted critical value ( P < .008 ) .


There was a significant effect of the intervention on whole-body BMC ( P = .04 , ( 2 ) < .001 ) and BMD ( P = .01 , ( 2 ) = .003 ) using the unadjusted critical value ( P < .05 ) .


The effect of the intervention on percent body fat ( P = .09 , ( 2 ) = .001 ) and whole-body fat mass ( P = .05 , ( 2 ) = .003 ) approached significance using unadjusted criteria .


There was not a significant effect on whole-body lean soft tissue ( P = .28 , ( 2 ) < .001 ) or body mass index ( P = .86 , ( 2 ) < .001 ) .


Our results provide preliminary evidence that an internet-delivered lifestyle physical activity intervention might improve bone health and body composition in MS. Such findings are important considering that physical activity is a modifiable behavior with the potential to confer long-term benefits for the prevention and management of fracture risk and comorbidities among those with MS.


After kidney transplantation , immunosuppressive therapy causes impaired cellular immune defense leading to an increased risk of viral complications .


Trough level monitoring of immunosuppressants is insufficient to estimate the individual intensity of immunosuppression .


We have already shown that virus-specific T cells ( Tvis ) correlate with control of virus replication as well as with the intensity of immunosuppression .


The multicentre IVIST01-trial should prove that additional steering of immunosuppressive and antiviral therapy by Tvis levels leads to better graft function by avoidance of over-immunosuppression ( for example , viral infections ) and drug toxicity ( for example , nephrotoxicity ) .


The IVIST-trial starts 4weeks after transplantation .


Sixty-four pediatric kidney recipients are randomized either to a non-intervention group that is only treated conservatively or to an intervention group with additional monitoring by Tvis .


The randomization is stratified by centre and cytomegalovirus ( CMV ) prophylaxis .


In both groups the immunosuppressive medication ( cyclosporine A and everolimus ) is adopted in the same target range of trough levels .


In the non-intervention group the immunosuppressive therapy ( cyclosporine A and everolimus ) is only steered by classical trough level monitoring and the antiviral therapy of a CMV infection is performed according to a standard protocol .


In contrast , in the intervention group the dose of immunosuppressants is individually adopted according to Tvis levels as a direct measure of the intensity of immunosuppression in addition to classical trough level monitoring .


In case of CMV infection or reactivation the antiviral management is based on the individual CMV-specific immune defense assessed by the CMV-Tvis level .


Primary endpoint of the study is the glomerular filtration rate 2years after transplantation ; secondary endpoints are the number and severity of viral infections and the incidence of side effects of immunosuppressive and antiviral drugs .


This IVIST01-trial will answer the question whether the new concept of steering immunosuppressive and antiviral therapy by Tvis levels leads to better future graft function .


In terms of an effect-related drug monitoring , the study design aims to realize a personalization of immunosuppressive and antiviral management after transplantation .


Based on the IVIST01-trial , immunomonitoring by Tvis might be incorporated into routine care after kidney transplantation .


EudraCT No : 2009-012436-32 , ISRCTN89806912 ( 17 June 2009 ) .


Breathing-retraining and helium-oxygen ( heliox ) have been used to improve exercise tolerance in COPD .


We hypothesized that , in patients with COPD , exercise duration after exercise-training plus breathing-retraining and oxygen would be longer than after exercise-training plus heliox or after exercise-training plus oxygen alone .


We also explored the short-term maintenance of gains in exercise duration after using each technique .


Of 192 COPD patients recruited , 103 were randomly assigned to exercise-training plus heliox ( n = 33 ) , exercise-training plus breathing-retraining and oxygen ( n = 35 ) and exercise-training and oxygen ( n = 35 ) .


FiO2 was 0.30 during testing and training in all groups .


Patients exercised on a treadmill thrice-weekly for eight weeks .


Before , at completion of training , and six-weeks later , patients underwent constant-load treadmill testing .


At completion of training , improvements in exercise duration in the heliox and breathing-retraining groups were not significantly different .


Compared to the exercise-training plus oxygen group , exercise duration improved more in the breathing-retraining group ( P = 0.008 ) but not in the heliox group ( P = 0.142 ) .


Hyperinflation was reduced with breathing-retraining plus oxygen compared to the other two groups .


Six-weeks later , improvements in exercise duration were still greater with breathing-retraining than with exercise-training ( P = 0.015 ) .


In contrast , improvements in exercise duration with heliox did not differ from those in the other two groups .


In moderate-to-severe COPD , exercise-training combined with either heliox or with breathing-retraining yielded not significantly different improvements in exercise duration - with only the latter being superior to exercise-training .


Six-weeks after training , these improvements were still greater after exercise-training plus breathing-retraining than after exercise-training .


ClinicalTrials.gov ; No. : NCT00123422 .


The incidence of transfusion-related acute lung injury ( TRALI ) in cardiac surgery patients is high and this condition contributes to an adverse outcome .


Damage-associated molecular pattern ( DAMP ) molecules , HMGB1 and S100A12 , are thought to mediate inflammatory changes in acute respiratory distress syndrome .


We aimed to determine whether DAMP are involved in the pathogenesis of TRALI in cardiac surgery patients .


This was a secondary analysis of a prospective observational trial in cardiac surgery patients admitted to the Intensive Care Unit of a university hospital in the Netherlands .


Fourteen TRALI cases were randomly matched with 32 transfused and non-transfused controls .


Pulmonary levels of HMGB1 , S100A12 and inflammatory cytokines ( interleukins-1 , -6 , and -8 and tumour necrosis factor - ) were determined when TRALI evolved .


In addition , systemic and pulmonary levels of soluble receptor for advanced glycation end products ( sRAGE ) were determined .


HMGB1 expression and levels of sRAGE in TRALI patients did not differ from those in controls .


There was a trend towards higher S100A12 levels in TRALI patients compared to the controls .


Furthermore , S100A12 levels were associated with increased levels of markers of pulmonary inflammation , prolonged cardiopulmonary bypass , hypoxemia and duration of mechanical ventilation .


No evidence was found that HMGB1 and sRAGE contribute to the development of TRALI .


S100A12 is associated with duration of cardiopulmonary bypass , pulmonary inflammation , hypoxia and prolonged mechanical ventilation and may contribute to acute lung injury in cardiac surgery patients .


The objective of this study was to evaluate the pharmacokinetic parameters of triflusal and its major active metabolite , 2-hydroxy-4-trifluoromethyl benzoic acid ( HTB ) , following a single oral dose of 900 mg in healthy subjects under fed and fasting conditions .


The study participants ( n = 12 ) were randomized to receive one 900 mg triflusal capsule in a fasting condition ( no food for 12 hours ) or a fed condition ( after a high-fat meal ) ; after a 2-week washout period , participants received the same dose of triflusal capsule under the converse condition .


Pharmacokinetic parameters were calculated using WinNonlin 6.2 software .


Safety was evaluated through assessment of adverse events , standard laboratory evaluations , vital signs , and 12-lead electrocardiography .


The mean Cmax of triflusal and HTB were 13.96 , 110.2 ug/mL for the fasting state and 9.546 , 97.15 ug/mL for the fed state , respectively .


The AUC0-144 of triflusal and HTB were 19.66 , 5,572 hxg/mL for the fasting state and 22.20 , 5,038 hxg/mL for the fed state , the AUC0 - of triflusal and HTB were 19.79 , 6,333 hxg/mL for the fasting state and 22.44 , 5,632 hxg/mL for the fed state , respectively .


The results showed that Cmax and AUCs for triflusal were outside the bioequivalency ( BE ) interval after food intake , but there was no statistically significant change for HTB .


High-fat food intake may affect the pharmacokinetics of triflusal capsule in healthy subjects .


This research compared the effects of real versus hyper-real images on anxiety , disgust , and physiological arousal during internet-delivered exposure in high spider-fearfuls .


Hyper-real images were digitally altered to highlight fearful aspects .


A further aim was to examine self-reported and behavioural therapeutic outcomes and exposure-related predictors of these outcomes .


Twenty-eight females were randomised to real ( n = 14 ) or hyper-real ( n = 14 ) treatment groups and nine participants were subsequently allocated to a wait-list control group .


Treatment groups viewed an 8-stage exposure hierarchy of real or hyper-real spider images .


Subjective anxiety and disgust ratings were taken during each stage ( 0 , 60 , 120 , 180s ) with heart rate and skin conductance recorded throughout .


Anxiety , disgust and physiological arousal habituated within each exposure stage , with no differential effect of real compared to hyper-real images .


Both treatment groups but not controls demonstrated significant reductions in behavioural avoidance and self-reported phobic symptoms from pre-treatment to post-treatment with large effect sizes noted .


The change in within-stage habituation of anxiety , disgust and heart rate , between the first and last stage , predicted improvement in behavioural avoidance at post-treatment .


This suggests that generalisation of habituation to multiple images is an important predictor of improvement .


While findings in relation to therapeutic outcome should be considered preliminary , clear relationships were found between exposure-related variables and outcome among those who undertook treatment .


Findings provide evidence in support of the efficacy of online image-based exposure and have implications for informing further research into the underlying mechanisms of image-based exposure treatment .


Recently , obesity patients have been diagnosed as metabolic syndrome .


The aim of this study was to evaluate which angiotensin type 1 receptor blockers ( ARBs ) , telmisartan or candesartan , is superior for the control of home blood pressure ( BP ) in the morning when the outpatient clinic BP was well controlled in the patients with metabolic syndrome .


The patients with metabolic syndrome were enrolled .


Home BP was monitored by using a telemedicine system .


After a 2 - to 4-week control period to establish baseline home BP values , these patients were randomly divided into telmisartan ( 20-80 mg ) and candesartan ( 4-12 mg ) groups .


These end points were evaluated by using the telemedicine system during steady-state active therapy .


A total of 356 patients attending 60 outpatient Japanese centers were recruited .


On a day of active therapy , telmisartan significantly lowered both systolic and diastolic home BP in the morning to a greater extent compared to candesartan .


At the end of the study , reductions in systolic and diastolic home BP in the morning , in telmisartan group were significantly larger compared to the changes in the candesartan group ( systolic ; Tel : 12.0 8.9 versus Can : 8.1 17.1 mmHg , p = 0.0292 , diastolic ; Tel : 7.4 6.1 versus Can : 3.7 6.8 mmHg , p = 0.0053 ) .


Additionally in the telmisartan treated group , LDL-cholesterol showed significant reduction ( p = 0.037 ) , but candesartan did not .


The present study by using the telemedicine system clearly demonstrated that telmisartan has a strong effect on reducing morning home BP , and a good effect on lipid metabolism in patients with metabolic syndrome .


Most men diagnosed with prostate cancer become long-term survivors , but are at risk for medical late-effects that can affect their long-term health .


Mailed surveys are well suited to study late-effects in this population , but low response rates can compromise survey validity .


This study investigated whether an unconditional $ 5.00 gift certificate incentive or Priority Mail delivery increased prostate cancer survivors ' response to mailed surveys .


976 participants ( mean age = 66.8 years ) , 2-8 years post-diagnosis , were randomized to one of four groups : Incentive ; Priority Mail ; Incentive & Priority Mail ; or Control .


After an introductory letter , initial study packets were mailed based on randomization ; 46 days later , a second study packet was mailed to all non-responders by First-Class Mail .


The first mailing yielded a significant variation in response rates across groups ( ( 2 ) = 9.34 ; p = 0.025 ) .


Priority Mail ( 64.7 % ; p = 0.008 ) and Incentive & Priority Mail ( 63.6 % ; p = 0.016 ) groups had significantly higher response rates than Controls ( 52.9 % ) .


After the second mailing , the overall response rate increased significantly from 59.6 % to 71.4 % ( p < 0.001 ) ; however , response rates no longer differed across groups ( range , 69.3 % [ Incentive group ] to 73.9 % [ Priority Mail group ] ) .


Long-term prostate cancer survivors ' response rates to mailed surveys increased with the use of Priority Mail and a repeat survey mailing , but the unconditional gift certificate incentive was not supported in this population .


By identifying and applying specialized survey methods , studies targeting survivors of prostate cancer and other geriatric cancers may improve response rates , thus limiting a source of potential bias .


To assess , in a randomised controlled trial ( RCT ) and in clinical practice , an association of time to remission and baseline disease activity with both induction of remission and sustained remission in etanercept-treated patients with rheumatoid arthritis ( RA ) .


Data from an RCT ( Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes [ TEMPO ] ; n = 682 ) and an observational registry ( Rheumatoid Arthritis DMARD Intervention and Utilization Study [ RADIUS II ] ; n = 4341 ) were used to evaluate disease activity ( Clinical Disease Activity Index [ CDAI ] score ) over time in patients initiating etanercept ( monotherapy or with methotrexate ) .


CDAI remission ( CDAI2 .8 ) and sustained remission ( 6 months ) were determined through year 3 by treatment group , study , time to remission , and disease severity .


Patients from TEMPO and RADIUS II who received etanercept monotherapy showed similar CDAI remission rates ( 39 % and 35 % , respectively , at 3 years ) .


Among patients who received etanercept with methotrexate , remission rates were 54 % and 36 % , respectively .


Remission occurred more rapidly in TEMPO than RADIUS II perhaps from differences in compliance , patient populations , or sequence of combination therapy initiation .


Generally , more patients with lower baseline CDAI scores achieved remission than those with higher scores .


Continued remission appeared more likely in patients achieving remission earlier in the course of their therapy ( 0-6 months ) .


Remission by year 3 in etanercept-treated ( with and without methotrexate ) patients with RA occurred in 35 % of patients in both an RCT ( TEMPO ) and a clinical practice setting ( RADIUS II ) , and more frequently in those with lower baseline disease severity .


Patients with lower RA disease activity were more likely to reach remission .


Continued remission may be more likely in patients who achieved remission earlier .


To evaluate the agreement between tumour volume derived from semiautomated volumetry ( SaV ) and tumor volume defined by spherical volume using longest lesion diameter ( LD ) according to Response Evaluation Criteria In Solid Tumors ( RECIST ) or ellipsoid volume using LD and longest orthogonal diameter ( LOD ) according to World Health Organization ( WHO ) criteria .


Twenty patients with metastatic colorectal cancer from the CIOX trial were included .


A total of 151 target lesions were defined by baseline computed tomography and followed until disease progression .


All assessments were performed by a single reader .


A variance component model was used to compare the three volume versions .


There was a significant difference between the SaV and RECIST-based tumour volumes .


The same model showed no significant difference between the SaV and WHO-based volumes .


Scatter plots showed that the RECIST-based volumes overestimate lesion volume .