To investigate the impact of including fluorine-@ fludeoxyglucose ( ( @ ) F-FDG ) positron emission tomography ( PET ) scanning in the planning of paediatric radiotherapy ( RT ) .


Target volumes were first delineated without and subsequently re-delineated with access to ( @ ) F-FDG PET scan information , on duplicate CT sets .


RT plans were generated for three-dimensional conformal photon RT ( @DCRT ) and intensity-modulated proton therapy ( IMPT ) .


The results were evaluated by comparison of target volumes , target dose coverage parameters , normal tissue complication probability ( NTCP ) and estimated risk of secondary cancer ( SC ) .


Considerable deviations between CT - and PET/CT-guided target volumes were seen in @ out of the @ patients studied .


However , averaging over the whole cohort , CT or PET/CT guidance introduced no significant difference in the shape or size of the target volumes , target dose coverage , irradiated volumes , estimated NTCP or SC risk , neither for IMPT nor @DCRT .


Our results imply that the inclusion of PET/CT scans in the RT planning process could have considerable impact for individual patients .


There were no general trends of increasing or decreasing irradiated volumes , suggesting that the long-term morbidity of RT in childhood would on average remain largely unaffected .


( @ ) F-FDG PET-based RT planning does not systematically change NTCP or SC risk for paediatric cancer patients compared with CT only .


@ out of @ patients had a distinct change of target volumes when PET-guided planning was introduced .


Dice and mismatch metrics are not sufficient to assess the consequences of target volume differences in the context of RT. .


High success rate of intubation and short intubation time have been needed to endoscopists for a complete and comfortable colonoscopy , if possible .


The purpose of present study was to compare procedure efficiencies according to adult-colonoscope length .


This was a prospective , randomized , single-blinded controlled trial .


A total of @ healthy Korean subjects were randomly assigned to two groups : one group receiving intermediate-length adult-colonoscope ( n = @ ) , and the other group receiving long-length adult-colonoscope ( n = @ ) .


Cecal intubation time and rate , and terminal ileal intubation time and rate as well as other procedure-related outcomes ( adenoma detection rate , withdrawal time , and total procedure time ) were evaluated .


There were significant differences in cecal intubation time and terminal ileal intubation rate according to colonoscope length .


The time of cecal intubation was shorter in the intermediate-scope group than that in the long-scope group ( ( @ @ ) s vs. ( @ @ ) s , P = @ ) .


However , the rate of terminal ileal intubation was higher in the long-scope group than that in the intermediate-scope group ( @ % vs. @ % , P = @ ) .


In addition , terminal ileal intubation time was also shorter in the long-scope group than that in the intermediate-scope group ( ( @ @ ) s vs. ( @ @ ) s , P < @ ) .


There were no significant differences in other procedure-related outcomes between the two groups .


The intermediate-length adult-colonoscope had an advantage over the long-length adult-colonoscope regarding cecal intubation time , whereas the long-scope had an advantage over the intermediate-scope regarding the rate and time of terminal ileal intubation .


These results suggest that it is rational to prepare and use these two types of colonoscope properly , instead of employing only one type of colonoscope .


No medical treatment has been reliably shown to halt or reverse disease progression in hypertrophic cardiomyopathy , but the results of several pilot studies have suggested beneficial effects of angiotensin II receptor blockers on left ventricular hypertrophy and fibrosis , which are predictive of an adverse outcome .


We aimed to assess the effect of the angiotensin II receptor blocker losartan on left ventricular hypertrophy and fibrosis in patients with hypertrophic cardiomyopathy .


In this single-centre , randomised , double-blind , placebo-controlled trial , adult patients ( aged @ years and older ) with obstructive or non-obstructive hypertrophic cardiomyopathy were randomly assigned via computer-based system to losartan ( @ mg per day ) or placebo for @ months .


Patients and investigators were masked to assigned treatment .


The primary endpoint was change in left ventricular mass as assessed by cardiac magnetic resonance imaging ( CMR ) or CT. .


Efficacy analyses were done in the modified intention-to-treat population ( all patients with data available at the @-month follow-up ) .


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


Between Dec @ , @ , and May @ , @ , @ patients were screened .


@ patients ( mean age @ years -LSB- SD @ -RSB- , @ % women ) consented and were randomly assigned to placebo ( n = @ ) or losartan ( n = @ ) .


@ ( @ % ) patients completed the study and were included in the modified intention-to-treat analysis for the primary endpoint .


After @ months we noted no significant difference in the change in left ventricular mass between the placebo group and the losartan group ( mean difference @ g/m ( @ ) , @ % CI -@ to @ ; p = @ ) .


A decrease in systolic blood pressure in the losartan group ( from mean @ mm Hg -LSB- SD @ -RSB- to @ mm Hg -LSB- @ -RSB- ; p = @ ) confirmed drug compliance ; blood pressure did not decrease in the placebo group .


Two ( @ % ) patients , both in the placebo group , died from sudden cardiac death during follow-up .


In the losartan group , one ( @ % ) patient had angioedema , one ( @ % ) had deterioration of renal function , and one ( @ % ) had hyperkalaemia .


Treatment was well tolerated by patients with left ventricular outflow obstruction at baseline .


Our findings challenge the generally held view that angiotensin II receptor blockers reduce cardiac hypertrophy .


Treatment with losartan was safe , suggesting that it can be used for other indications in patients with hypertrophic cardiomyopathy , irrespective of obstructive physiology .


Additional studies are needed to assess the effect of angiotensin II receptor blockers in preclinical hypertrophic cardiomyopathy-eg , in genotype-positive but phenotype-negative individuals .


To evaluate electroacupuncture on the efficacy and the safety of gastric and systemic functional recovery in patients with carbon dioxide pneumoperitoneum undergoing gynaecological laparoscopic surgery .


Sixty patients undergoing gynaecological laparoscopic surgery were randomly divided into a regular anesthesia group ( group A ) and a combination electroacupuncture anesthesia group ( group B ) , @ cases in each group .


The group A were treated with regular general anesthesia , and on the basis of general anesthesia , the group B were treated with electroacupuncture at bilateral Zusanli ( ST @ ) and Liangqiu ( ST @ ) by continuous wave and a frequency of @ Hz @ minutes before the surgery until the end of the operation .


Sedation scale by Ramsay , nausea , vomiting and mental state scores of postoperative were evaluated and compared between the two groups .


Compared with the group A , the sedation scale ( @ + / - @ vs @ + / - @ ) , nausea score ( @ + / - @ vs @ + / - @ ) , vomiting score ( @ + / - @ vs @ + / - @ ) and mental state score ( @ + / - @ vs @ + / - @ ) were all decreased significantly in the group B ( all P < @ ) .


Combination electroacupuncture anesthesia can relieve postoperative irritable , nausea and vomiting , improve mental state after the operation and promote the gastric and systemic functional recovery .


It is a good method for the adjustment of carbon dioxide pneumoperitoneum during laparoscopic surgery .


To examine whether an efficacious voucher-based incentives intervention for decreasing smoking during pregnancy and increasing fetal growth could be improved without increasing costs .


The strategy was to redistribute the usual incentives so that higher values were available early in the quit attempt .


@ pregnant smokers in greater Burlington , Vermont ( studied December , @-June , @ ) were randomly assigned to the revised contingent voucher ( RCV ) or usual contingent voucher ( CV ) schedule of abstinence-contingent vouchers , or to a non-contingent voucher ( NCV ) control condition wherein vouchers were provided independent of smoking status .


Smoking status was biochemically verified ; serial sonographic estimates of fetal growth were obtained at gestational weeks @-@ .


RCV and CV conditions increased point-prevalence abstinence above NCV levels at early ( RCV : @ % , CV : @ % , NCV : @ % , p = @ ) and late-pregnancy ( RCV : @ % ; CV : @ % ; NCV , @ % ; p = @ ) assessments , but abstinence levels did not differ between the RCV and CV conditions .


The RCV intervention did not increase fetal growth above control levels while the CV condition did so ( p < @ ) .


This trial further supports the efficacy of CV for increasing antepartum abstinence and fetal growth , but other strategies ( e.g. , increasing overall incentive values ) will be necessary to improve outcomes further .


The surgical resection of lung disrupts glucose homeostasis and causes hyperglycemia , as in any other major surgery or critical illness .


We performed a prospective study where we carefully lowered hyperglycemia by insulin administration during the surgery , and for the first time we monitored immediate insulin effects on lung physiology and gene transcription .


The levels of blood gases ( pH , pCO@ , pO@ , HCO@ - , HCO@ - std , base excess , FiO@ , and pO@/FiO@ ) were measured at the beginning of surgery , at the end of surgery , and two hours after .


Samples of healthy lung tissue surrounding the tumour were obtained during the surgery , anonymized and sent for subsequent blinded qPCR analysis ( mRNA levels of surfactant proteins A@ , A@ , B , C and D were measured ) .


This study was done on a cohort of @ patients who underwent lung resection .


Patients were randomly divided , and half of them received insulin treatment during the surgery .


We demonstrated for the first time that insulin administered intravenously during lung resection does not affect levels of blood gases .


Furthermore , it does not induce immediate changes in the expression of surfactant proteins .


According to our observations , short insulin treatment applied intravenously during resection does not affect the quality of breathing .


Postoperative atrial fibrillation is a common complication after cardiac surgery , with an incidence as high as @-@ % .


Increased age is associated with a significant increase in postoperative atrial fibrillation risk .


This common complication is associated with higher morbidity and mortality rates .


The aim of this study was to assess the efficacy of nebivolol in preventing atrial fibrillation following coronary artery bypass surgery in patients over @ years of age .


In this prospective randomized study , @ patients who were candidates for elective coronary artery bypass surgery were divided into two groups .


The first group was administered with nebivolol and the second group was administered with metoprolol .


Treatment was initiated four days prior to surgery , and patients were monitored for atrial fibrillation until discharge .


Forty-one patients received @ mg metoprolol succinate daily , which was initiated minimum @ days before surgery .


Demographic data were similar in both groups .


The incidence of postoperative atrial fibrillation in both groups was similar , with no significant difference being identified -LSB- n = @ ( @ % ) ; n = @ ( @ % ) , P = @ ; respectively -RSB- .


There were not any mortality at both groups during study .


Inotropic agent requirement at ICU was similar for both groups -LSB- n = @ ( @ % ) , n = @ ( @ % ) , P = @ -RSB- .


We compared the effectiveness of nebivolol and metoprolol in decreasing the incidence of postoperative atrial fibrillation , and determined that nebivolol was as effective as metoprolol in preventing postoperative atrial fibrillation at patients .


Nebivolol may be the drug of choice due to its effects , especially after elective coronary artery bypass surgery .


As a part of nationwide healthcare reforms , the Chinese government launched web-based appointment systems ( WAS ) to provide a solution to problems around outpatient appointments and services .


These have been in place in all Chinese public tertiary hospitals since @ .


Questionnaires were collected from both patients and doctors in one large tertiary public hospital in Shanghai , China.Data were analyzed to measure their satisfaction and views about the WAS .


The @ outpatients randomly selected for the survey were least satisfied about the waiting time to see a doctor .


Even though the WAS provided a much more convenient booking method , only @ % of patients used it .


Of the @ doctors surveyed , over @ % thought it was necessary to provide alternative forms of appointment booking systems for outpatients .


However , about @ % of those doctors who were not associated professors would like to provide an ` on-the-spot ' appointment option , which would lead to longer waits for patients .


Patients were least satisfied about the waiting times .


To effectively reduce appointment-waiting times is therefore an urgent issue .


Despite the benefits of using the WAS , most patients still registered via the usual method of queuing , suggesting that hospitals and health service providers should promote and encourage the use of the WAS .


Furthermore , Chinese health providers need to help doctors to take others ' opinions or feedback into consideration when treating patients to minimize the gap between patients ' and doctors ' opinions .


These findings may provide useful information for both practitioners and regulators , and improve recognition of this efficient and useful booking system , which may have far-reaching and positive implications for China 's ongoing reforms .


To examine the prediction of gestational diabetes in obese women using routine clinical measures and measurement of biomarkers related to insulin resistance in the early second trimester .


A total of @ obese pregnant women participating in a pilot trial of a complex intervention of dietary advice and physical activity were studied .


Blood samples were obtained at recruitment ( @-@ weeks ' gestation ) and demographic , clinical history and anthropometric measures recorded .


The biomarkers analysed were plasma lipids ( HDL cholesterol , LDL cholesterol , triglycerides ) , high-sensitivity C-reactive protein , alanine transaminase , aspartate transaminase , ferritin , fructosamine , insulin , adiponectin , tissue plasminogen activator , interleukin-@ , visfatin and leptin .


Univariate and logistic regression analyses were performed to determine independent predictors and area under the receiver-operating curve was calculated for the model .


Of the @ participants included in the analysis , @ ( @ % ) developed gestational diabetes .


Participants with gestational diabetes were older ( P = @ ) , more often of parity @ , had higher systolic ( P = @ ) and diastolic blood pressure ( P = @ ) and were more likely to be black ( P = @ ) .


Amongst the blood biomarkers measured , plasma adiponectin alone remained independently associated with gestational diabetes in adjusted models ( P = @ ) .


The area under the receiver-operating curve for clinical factors alone ( @ ) increased significantly ( area under the curve @ , chi-square statistic ( @ ) = @ , P = @ ) with the addition of adiponectin .


A combination of routinely measured clinical factors and adiponectin measured in the early second trimester in obese women may provide a useful approach to the prediction of gestational diabetes .


Validation in a large prospective study is required to determine the usefulness of this algorithm in clinical practice .


Cyclooxygenase-@ ( COX-@ ) is expressed in all female reproductive organs .


Therefore , inhibitors of COX-@ may affect reproductive function .


We evaluated the effect of extended administration of meloxicam on ovulation and the menstrual cycle .


Our hypothesis was that meloxicam administered from menstrual cycle day @ - @ could interfere with follicular rupture , without disrupting the menstrual cycle , and could be a potential non-hormonal contraceptive method .


The study was conducted in @ healthy sterilized women .


Before the onset of treatment and after the end of treatment , participants were observed during a control cycle to ensure that they had progesterone ( P ) serum levels ( > @ nmol/l ) consistent with ovulation .


Participants were treated for @ days , during three consecutive cycles .


They were randomized to @ or @ mg/day .


The menstrual cycle was monitored with serial ultrasound and hormone assays in blood .


Fifty-six volunteers completed the study .


In @ % of cycles treated with @ mg/day and in @ % of cycles treated with @ mg/day ( p < @ ) we observed dysfunctional ovulation defined as follicular rupture not preceded @-@ h earlier by an LH peak or preceded by a blunted LH peak ( < @ IU/l ) or not followed by an elevated serum P level > @ nmol/l .


Ovulation was observed in @ % and in @ % of women in the lower dose group and the higher dose group , respectively .


There were no differences between the two doses in other parameters measured .


There were no serious adverse events and adverse events were not different between doses or between control and treated cycles .


Although administration of meloxicam on menstrual cycle days @ - @ resulted in a dose-dependent inhibition of ovulation , more than @ % of subjects had normal ovulation with the highest dose .


Previous studies have shown that oral meloxicam can delay follicle rupture .


This study investigated daily oral meloxicam as a non-hormonal contraceptive .


Since ovulation occurs in over @ % of cycles even with a high dose of @ mg daily , it is not likely that the approach would be a highly effective contraceptive strategy .


Urodynamic studies are commonly performed as part of the preoperative work-up of patients undergoing surgery for stress urinary incontinence ( SUI ) .


We aimed to assess the extent to which these urodynamic parameters influence patient selection and postoperative outcomes .


Patients presenting with SUI were randomly assigned to two groups : one undergoing office evaluation only and the other with a preoperative urodynamic work-up .


Patients with unfavorable urodynamic parameters ( detrusor overactivity -LSB- DO -RSB- and/or Valsalva leak point pressure -LSB- VLPP -RSB- < @ cm H@O and/or maximum urethral closure pressure -LSB- MUCP -RSB- < @ cm H@O ) were excluded from the urodynamic testing group .


All patients in both groups underwent the transobturator midurethral sling procedure .


Evaluation for treatment success ( reductions in urogenital distress inventory and incontinence impact questionnaire scoring along with absent positive stress test ) was done at @ months and @ year postoperatively .


A total of @ patients were evaluated .


After @ patients with any one or more of the abnormal urodynamic parameters were excluded , @ patients were finally recruited in each of the `` urodynamic testing '' and `` office evaluation only '' groups .


At both the @ - and the @-month follow-ups , treatment outcomes ( reduction in scores and positive provocative stress test ) were significantly better in the urodynamic testing group than in the office evaluation only group ( p-values significant for all outcomes ) .


Our findings showed statistically significantly better treatment outcomes in the urodynamic group ( after excluding those with poor prognostic indicators such as DO , low VLPP , and MUCP ) than in the office evaluation only group .


We recommend exploiting the prognostic value of these urodynamic parameters for patient counseling and treatment decisions .


Total hip replacement ( THR ) is a common elective surgical procedure and can be effective for reducing chronic pain .


However , waiting times can be considerable .


A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery .


This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR .


Patients listed for a THR at one orthopedic center were posted a study invitation pack .


Participants were randomized to attend a pain self-management course plus standard care or standard care only .


The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery .


Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month , three months and six months after surgery .


Brief telephone interviews were conducted with non-participants to explore barriers to participation .


Invitations were sent to @ eligible patients and @ patients ( @ % ) consented to participate .


Interviews with @ non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties .


Of the @ patients randomized to the intervention group , @ attended the pre-operative pain self-management sessions and @ attended the post-operative sessions .


Participant satisfaction with the course was high , and feedback highlighted that patients enjoyed the group format .


Retention of participants was acceptable ( @ % of recruited patients completed follow-up ) and questionnaire return rates were high ( @ % to @ % ) , with the exception of the pre-operative resource-use diary ( @ % return rate ) .


Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective .


This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates , barriers to participation , logistics of scheduling group-based interventions , acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations .


This information is of value to researchers and funders in the design and commissioning of future research .


Evaluate curricular changes related to health literacy and determine impact on independent-living senior residents as part of an introductory pharmacy practice experience for third-year student pharmacists .


Students were randomly assigned a resident whom they visited multiple times to conduct assessments and provide various services using three methods : Ask Me @ Four Habits Model , and Teach-back .


The study was conducted at independent-living apartments within a @-mile radius from the St. Louis College of Pharmacy , St. Louis , Missouri .


Participants ( n = @ to @ , across all three years ) were volunteer , elderly residents , living at a facility that collaborated with the research .


Within one academic year , students collected medical and medication histories , conducted household safety checks , performed screening assessments , assessed adherence , and provided general recommendations to a resident .


Outcomes included resident satisfaction , student satisfaction , and correlations between student use of health literacy tools and resident satisfaction .


Exit surveys indicated resident overall satisfaction with the program , increased understanding of health-related information , increased confidence in asking health care professionals questions about their health , and greater commitment to medication adherence as a result of the experience .


Students were highly satisfied with the program .


Analyses reveal some correlations between a previously determined performance level of student communication and resident satisfaction .


Students ' use of health literacy communication tools during encounters with independent-living senior residents can result in greater patient understanding and empowerment , which may in turn help improve medication adherence .


Recent research has pointed to the cardiovascular benefits of providing social support to others in times of stress ; however , little is known about what factors influence such benefits .


In a between-groups design , we investigated the possible interaction between intimacy ( friend vs. stranger ) and support type ( active vs. passive ) in determining the cardiovascular responses of support providers .


Eighty participants had their blood pressure and heart rate monitored while providing either active or passive social support to a friend or a stranger who completed a stress task .


Although there was no interaction effect , a significant main effect showed that those who provided passive support showed larger decreases relative to those in the active support condition .


There was no effect of intimacy .


Further , these effects withstood adjustment for a number of potential confounds ( e.g. sex and body mass index ) .


It appears that the greatest physiological benefit for social support providers may come from providing passive , rather than active support , regardless of whether the support receiver is a friend or a stranger .


Many authors recommend performing a second-look endoscopy ( SLE ) to reduce the frequency of delayed bleeding after endoscopic submucosal dissection ( ESD ) for gastric neoplasms , but these recommendations have been made despite a lack of reliable evidence supporting the effectiveness of SLE .


From January @ to May @ , we investigated @ gastric neoplasms treated by ESD to assess the risk factors for delayed bleeding .


Delayed bleeding occurred in four of these lesions within @ postoperation day .


Therefore , we enrolled the patients with the remaining @ lesions to determine the utility of SLE performed on the morning of postoperative day @ .


All lesions were randomly assigned to SLE ( @ lesions ) groups or non-SLE ( @ lesions ) groups .


Delayed bleeding occurred in @ lesions ( @ % ) .


A large tumor size ( > @ mm ) was the only independent risk factor for delayed bleeding ( p = @ ) .


The chance of delayed bleeding was not significantly different between the patients receiving a SLE ( eight cases ) and those patients not receiving a SLE ( six cases , p = @ ) .


Furthermore , SLE for lesions with a large tumor size did not significantly decrease delayed bleeding ( p = @ ) .


SLE had little or no influence on the prevention of delayed bleeding , irrespective of the risk factors .


Chronic ankle instability ( CAI ) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle 's giving way .


Compared with healthy people , patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure ( COP ) during a single-limb static-balance task on a force plate .


Balance training is an effective means of altering traditional COP measures ; however , whether the overall location of the COP distribution under the foot also changes is unknown .


To determine if the spatial locations of COP data points in participants with CAI change after a @-week balance-training program .


Randomized controlled trial .


Laboratory .


Thirty-one persons with self-reported CAI .


Participants were randomly assigned to a @-week balance-training program or no balance training .


We collected a total of @ COP data points while participants balanced using a single limb on a force plate during a @-second trial .


The location of each COP data point relative to the geometric center of the foot was determined , and the frequency count in @ sections ( anteromedial , anterolateral , posteromedial , posterolateral ) was analyzed for differences between groups .


Overall , COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials ( before trial = @ @ , after trial = @ @ ; P = @ ) and eyes-closed trials ( before trial = @ @ , after trial = @ @ ; P < @ ) .


The COP for the group that did not perform balance training remained the same in the eyes-open trials ( before trial = @ @ , after trial = @ @ ; P = @ ) and eyes-closed trials ( before trial = @ @ , after trial = @ @ ; P = @ ) .


In participants with CAI , the balance-training program shifted the COP location from anterolateral to posterolateral .


The program may have repaired some of the damaged sensorimotor system pathways , resulting in a more optimally functioning and less constrained system .


Research suggests that the addition of dexmedetomidine to local anesthetics can prolong peripheral nerve blocks ; however , clinical safety data are limited , and interscalene blocks have not been studied .


The present study was designed to test the hypothesis that dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone .


We conducted a single-center , prospective , randomized , triple-blind , controlled trial of @ patients undergoing elective shoulder surgery under general anesthesia with an interscalene block .


Patients underwent ultrasound-guided interscalene blocks using either @ mL of @ % ropivacaine or @ % ropivacaine plus @-g dexmedetomidine .


The primary outcomes were self-reported duration of the nerve block and safety assessment ( adverse effects and neurological sequelae ) .


Data were analyzed in a blinded fashion .


The median duration of the nerve block was @ hours ( @ % confidence interval , @-@ ) in the dexmedetomidine group and @ hours ( @ % confidence interval , @-@ ) in the ropivacaine group ( P = @ ) .


Dexmedetomidine also lowered pain scores for the first @ hours postoperatively and significantly hastened the time to sensory ( P = @ ) and motor ( P = @ ) block onset .


Dexmedetomidine lowered heart rate but blood pressures were stable .


Plasma levels of ropivacaine were not different between groups , and plasma dexmedetomidine levels were relatively low .


There were no adverse events or neurological sequelae .


Dexmedetomidine added to ropivacaine for interscalene blocks increased the duration of the nerve block and improved postoperative pain .


These additional efficacy and safety data should encourage further study of peripheral perineural dexmedetomidine in humans .


We hypothesized reduction of @ days ' in-hospital morbidity , mortality , and length of stay postimplementation of the World Health Organization 's Surgical Safety Checklist ( SSC ) .


Reductions of morbidity and mortality have been reported after SSC implementation in pre - / postdesigned studies without controls .


Here , we report a randomized controlled trial of the SSC .


A stepped wedge cluster randomized controlled trial was conducted in @ hospitals .


We examined effects on in-hospital complications registered by International Classification of Diseases , Tenth Revision codes , length of stay , and mortality .


The SSC intervention was sequentially rolled out in a random order until all @ clusters-cardiothoracic , neurosurgery , orthopedic , general , and urologic surgery had received the Checklist .


Data were prospectively recorded in control and intervention stages during a @-month period in @-@ .


A total of @ control procedures were compared with @ SCC procedures .


The complication rates decreased from @ % to @ % ( P < @ ) , with absolute risk reduction @ ( @ % confidence interval , @-@ @ ) from the control to the SSC stages .


Adjusted for possible confounding factors , the SSC effect on complications remained significant with odds ratio @ ( @ % confidence interval , @-@ @ ) .


Mean length of stay decreased by @ days with SCC utilization ( @ % confidence interval , @-@ @ ) .


In-hospital mortality decreased significantly from @ % to @ % in @ of the @ hospitals post-SSC implementation , but the overall reduction ( @ % -@ % ) across hospitals was not significant .


Implementation of the WHO SSC was associated with robust reduction in morbidity and length of in-hospital stay and some reduction in mortality .


To analyse the muscle adaptations induced by two protocols of isometric training performed at different muscle lengths .


Twenty-eight subjects were divided into three groups : one ( K@ ) performed isometric training of the knee extensors at long muscle lengths ( @ of knee flexion ) for @ weeks , and the second group ( K@ ) at short muscle lengths ( @ ) .


The subjects of the third group acted as controls .


Isokinetic dynamometry was utilized to analyse the net moment-angle relationship and vastus lateralis muscle thickness at three different locations , and pennation angles and fascicle length at @ % of thigh length were measured at rest with ultrasonography .


Only subjects from K@ group showed significant increases in isokinetic strength ( @ % , P < @ ) , while K@ group showed no increases in isokinetic strength : ( @ % , P > @ ) .


There was a shift in the angle of peak torque of the K@ group to longer muscle lengths ( +@ % , P = @ ) with greater increases in isokinetic strength , while the K@ angle shifted to shorter muscle lengths ( -@ % , P = @ ) .


Both training groups showed significant increases in muscle thickness , ( K@ @-@ % vs. K@ @-@ % ) but only K@ significantly increased their pennation angles ( @ % , P = @ ) .


Fascicle lengths remained unchanged .


Isometric training at specific knee angles led to significant shifts of peak torque in the direction of the training muscle lengths .


The greater strength gains and the architectural changes with training at long muscle lengths probably come from a combination of different factors , such as the different mechanical stresses placed upon the muscle-tendon complex .


The renoprotective effect of N-acetylcystein in patients undergoing coronary artery bypass graft surgery is controversial .


We assessed the renoprotective effect of the highest dose of N-acetylcystein sanctioned for clinical use in a prospective , double-blind , placebo-controlled study including @ chronic kidney disease patients , stage @ or @ , who underwent coronary artery bypass graft surgery , on cardiopulmonary bypass ( CPB ) and off CPB , and were randomly allocated to receive either N-acetylcystein @ mg/kg followed by @ mg/kg for @ hours in @ % saline or only @ % saline .


Acute kidney injury was defined by the Acute Kidney Injury Network classification .


The incidence of kidney injury was reduced in the N-acetylcystein group ( @ % versus @ % , p = @ ) .


Nonuse of N-acetylcystein ( relative risk @ , @ % confidence interval : @ to @ , p = @ ) and cardiopulmonary bypass ( relative risk @ , @ % confidence interval : @ to @ , p = @ ) were independent predictors of kidney injury .


In patients treated with CPB , N-acetylcystein reduced the incidence of kidney injury from @ % to @ % .


Oxidative stress was increased in control subjects ( p = @ ) and abolished in patients receiving N-acetylcystein .


Maximum intravenous doses of N-acetylcystein reduce the incidence of acute kidney injury in patients with kidney disease undergoing coronary artery bypass graft surgery , abolish oxidative stress , and mitigate the negative effect of CPB on renal function .


This randomised , double blind prospective study compares intrathecal lidocaine with chloroprocaine in day-case surgery and the influence of a @ ml pre-load intravenously .


We tested the hypothesis that chloroprocaine provides faster recovery and discharge in day-case surgery .


Secondary we studied the influence of a preload compared with fluid restriction on discharge time and micturition problems .


One hundred patients undergoing day-case arthroscopy were randomised to receive either lidocaine ( L ) @ mg or chloroprocaine ( CP ) @ mg intrathecally and this with ( L + , CP + ) or without ( L , CP ) a @ ml pre-load of crystalloid .


Block characteristics , micturition and discharge times were registered .


Bladder volumes were monitored by ultrasound .


Micturition problems received a micturition score .


Onset and quality of the block were comparable between groups .


Time to regain Bromage @ and L@ regression were shorter for the CP group compared with the L group .


Voiding ( @ @ min ) and discharge ( @ @ min ) were approximately @ min faster for the CP group compared with the L group .


Pre-load provided faster bladder filling but there were no differences in voiding time within the CP or L group .


The CP + group ( @ @ min ) was discharged faster than both L groups ( @ @ min , @ @ min ) .


More serious micturition problems occurred in the L + group compared with both CP groups .


Chloroprocaine is suitable for day-case surgery because of faster block regression and discharge than lidocaine .


A @ ml pre-load may not affect discharge but did not increase micturition problems for chloroprocaine .


To compare the efficacy of metformin with insulin in the management of pregnancy with diabetes .


Randomized clinical trial .


Department of Obstetrics and Gynaecology , Maternal and Child Health Centre ( MCH ) , Pakistan Institute of Medical Sciences , Islamabad , from May @ to January @ .


A total of @ pregnant patients with diabetes were included in this study .


Patients were randomly divided in to two groups of each @ patients based on table of random numbers .


One was labelled as group-A and other was labelled as group-B .


Group-A received insulin and group-B received metformin for the management of diabetes .


The mean age was @ @ and @ @ years in groups-A and B respectively .


Fasting blood sugar level after @ month was controlled in @ ( @ % ) patients in group-A and in @ ( @ % ) in group-B ( p > @ ) .


Fasting blood sugar level at term , remained controlled in @ ( @ % ) patients in group-A and @ ( @ % ) in group-B ( p > @ ) .


Comparison of random blood sugar levels within normal limits after @ month in @ ( @ % ) in group-A and in @ ( @ % ) in group-B .


At term , random blood sugar level was controlled in @ ( @ % ) and @ ( @ % ) patients in group-A and B , respectively .


Comparison of post-treatment HBA@C level depicts that diabetes controlled in @ ( @ % ) patients in group-A while in @ ( @ % ) patients of group-B .


The efficacy of metformin and insulin in controlling diabetes was equal in two groups .


There was no marked difference in efficacy of metformin and insulin in controlling diabetes in pregnant patients in two groups .


Depression is estimated to become the leading cause of disease burden globally by @ .


Despite existing efficacious treatments ( both medical and psychotherapeutic ) , a large proportion of patients do not respond to therapy .


Recent insights from evolutionary psychology suggest that , in addition to targeting the proximal causes of depression ( for example , targeting dysfunctional beliefs by cognitive behavioral therapy ) , the distal or evolutionary causes ( for example , inclusive fitness ) should also be addressed .


A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression , and to compare its efficacy against standard cognitive therapy for depression .


Romanian-speaking adults ( @ years or older ) with elevated Beck Depression Inventory ( BDI ) scores ( > @ ) , current diagnosis of major depressive disorder or major depressive episode ( MDD or MDE ) , and MDD with comorbid dysthymia , as evaluated by the Structured Clinical Interview for DSM-IV ( SCID ) , are included in the study .


Participants are randomized to one of two conditions : @ ) evolutionary-driven cognitive therapy ( ED-CT ) or @ ) cognitive therapy ( CT ) .


Both groups undergo @ psychotherapy sessions , and data are collected at baseline , mid-treatment , post-treatment , and the @-month follow-up .


Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment .


This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression .


To our knowledge , this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner .


This study can thus add substantially to the body of knowledge on validated treatments for depression .


This study aimed to examine healthcare provider ( HCP ) recommendations and patient preferences for the insulin pen versus vial-and-syringe in patients with type @ diabetes mellitus ( T@DM ) and to assess clinical end points and safety outcomes .


Using a randomized , open-label , crossover design , in total , @ insulin-naive adults with T@DM from @ centers received basal insulin glargine in one of two device treatment sequences ( @ weeks of pen followed by @ weeks of vial-and-syringe , or vice versa ) .


The primary end point , patient device preference , was evaluated at Week @ ( end of the crossover period ) using the Insulin Injection Preference Questionnaire .


Patient preference and HCP recommendation were assessed with one global item and three subscale items ( blood glucose control , reluctance to use insulin , and long-term insulin use ) using a @-point scale ranging from @ = not preferred or not recommended to @ = preferred or recommended .


Patients were then re-randomized to either pen or vial-and-syringe for further observation ( @ , @ , and @ weeks ) to evaluate clinical end points ( glycosylated hemoglobin -LSB- A@C -RSB- and fasting blood glucose levels ) and safety outcomes ( hypoglycemia and adverse events ) .


Patients reported a significant preference for pens over vial-and-syringe , and HCPs strongly recommended pens over vial-and-syringe ( both P < @ ) .


Consistent response patterns were observed by HCPs and patients for the three subscale items .


Fasting blood glucose , A@C levels , and the incidence of hypoglycemia were comparable in the two groups .


Patients preferred pens over vial-and-syringe , with the pen device also recommended by HCPs , when initiating basal insulin treatment in insulin-naive patients with T@DM .


Rejection is one of the major causes of late cardiac allograft failure and at present can only be diagnosed by invasive endomyocardial biopsies .


We sought to determine whether microRNA profiling could serve as a non-invasive biomarker of cardiac allograft rejection .


We included @ heart transplant recipients from four referral French institutions ( test cohort , n = @ , validation cohort , n = @ ) .


In the test cohort , we compared patients with acute biopsy-proven allograft rejection ( n = @ ) to matched control patients without rejection ( n = @ ) , by assessing microRNAs expression in the heart allograft tissue and patients concomitant serum using RNA extraction and qPCR analysis .


Fourteen miRNAs were selected on the basis of their implication in allograft rejection , endothelial activation , and inflammation and tissue specificity .


We identified seven miRNAs that were differentially expressed between normal and rejecting heart allografts : miR-@a , miR-@ , miR-@ , miR-@a , miR-@-@p miR-@ , and miR-@ ( P < @ for all comparisons ) .


Four out of seven miRNAs also showed differential serological expression ( miR-@a , miR-@ , miR-@a , and miR-@ ) with strong correlation with their tissular expression .


The receiver-operating characteristic analysis showed that these four circulating miRNAs strongly discriminated patients with allograft rejection from patients without rejection : miR-@a ( AUC = @ ) , miR-@ ( AUC = @ ) , miR-@a ( AUC = @ ) , and miR-@ ( AUC = @ , P < @ for all comparisons ) .


We confirmed in the external validation set that these four miRNAs highly discriminated patients with rejection from those without .


The discrimination capability of the four miRNAs remained significant when stratified by rejection diagnosis ( T-cell-mediated rejection or antibody-mediated rejection ) and time post-transplant .


This study demonstrates that a differential expression of miRNA occurs in rejecting allograft patients , not only at the tissue level but also in the serum , suggesting their potential relevance as non-invasive biomarkers in heart transplant rejection .


There has been little robust evaluation of the outcome of speech and language therapy ( SLT ) intervention for post-stroke dysarthria .


Non-speech oro-motor exercises ( NSOMExs ) are a common component of dysarthria intervention .


A feasibility study was designed and executed , with participants randomized into two groups , in one of which NSOMExs were a component of the intervention programme .


To examine ( @ ) operational feasibility of the programme ; ( @ ) participants ' views of the programme ; and ( @ ) speech intelligibility , communication effectiveness and tongue and lip movement at four points ( A@ and A@ before , and A@ and A@ after intervention ) .


Thirty-nine participants were randomized into Group A ( n = @ ) and Group B ( n = @ ) .


Groups were equivalent at enrolment in demographic variables and A@ measures .


Intervention was behavioural , delivered in eight home-based SLT sessions , and included practise of individually appropriate words , sentences and conversation , and for Group B also NSOMExs .


Between-session practice was recorded in a diary .


Data on speech intelligibility , effectiveness of communication in conversation , self-rated situational communication effectiveness , and tongue and lip movement were collected at @-week intervals , twice before and twice after intervention .


Anonymous evaluation ( AE ) questionnaires were completed .


The recruited number was @ % below the target of @ .


Thirty-six participants completed the intervention and @ were followed through to A@ .


The programme was delivered to protocol and fidelity was verified .


Thirty-four AEs were returned .


These showed high satisfaction with the programme and its outcome .


According to diary records from @ participants , @ % carried out at least the recommended practice amount .


Outcome measure performance across the four assessment points did not indicate any group effect .


For the whole sample both externally rated and self-rated communication effectiveness measures showed statistically significant gains across the intervention period ( A@/A@ ) , which were maintained for @ months after intervention ( A@/A@ ) .


Non-intervention period changes ( A@/A@ and A@/A@ ) were not present .


There were no intervention-related gains in tongue and lip movement or speech intelligibility , but the latter is likely to be attributable to a ceiling effect on scores .


The results indicate positive outcomes associated with a short period of behavioural SLT intervention in the post-stroke dysarthria population .


The inclusion of NSOMExs , delivered in accordance with standard clinical practice , did not appear to influence outcomes .


The results must be viewed in relation to the nature of feasibility study and provide a foundation for suitably powered trials .


Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass .


The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease .


This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias , selective reporting , and data-driven results as an update to the published design and method for the trial .


The pulmonary protection trial is a randomized , parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or Custodiol HTK ( histidine-tryptophan-ketoglutarate ) solution versus no pulmonary perfusion in @ chronic obstructive pulmonary disease patients .


Patients , the statistician , and the conclusion drawers are blinded to intervention allocation .


The primary outcome is the oxygenation index from @ to @ minutes after the end of cardiopulmonary bypass until @ hours thereafter .


Secondary outcome measures are oral tracheal intubation time , days alive outside the intensive care unit , days alive outside the hospital , and @ - and @-day mortality , and one or more of the following selected serious adverse events : pneumothorax or pleural effusion requiring drainage , major bleeding , reoperation , severe infection , cerebral event , hyperkaliemia , acute myocardial infarction , cardiac arrhythmia , renal replacement therapy , and readmission for a respiratory-related problem .


The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients .


A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome .


Recently , internet-based interventions have been proposed as effective treatments for people with panic disorder ( PD ) .


However , little is known about the clinical effects of integrating mobile technology into these interventions .


Because users carry their smartphones with them throughout the day , we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms .


The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD .


The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks .


A two-arm randomized controlled trial ( RCT ) will be conducted to evaluate the effects of a hybrid online training module for PD .


Based on a power calculation ( d = @ ; @ - of @ % ; = @ ) , @ participants with mild to moderate panic symptoms with or without agoraphobia ( as assessed by the Panic and Agoraphobia Scale ) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group .


The primary outcome measure will be the severity of panic symptoms .


Secondary outcomes will include depression , quality of life , and an observer-based rating of panic severity .


Furthermore , data regarding acceptance and the usability of the smartphone app will be assessed .


Assessments will take place at baseline as well as eight weeks , three months , and six months after randomization .


Moreover , a cost-effectiveness analysis will be performed from a societal perspective .


Data will be analyzed on an intention-to-treat basis and per protocol .


To our knowledge , this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD .


This study seeks to contribute to the emerging field of hybrid online training .


If the intervention is efficacious , then research on this hybrid online training should be extended .


The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults .


Heart disease progression occurs in @ % of patients with chronic Trypanosoma cruzi infection .


Supplementation with selenium ( Se ) in animal model of T. cruzi infection produced promising results .


There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease .


The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy .


The Selenium Treatment and Chagasic Cardiopathy trial is a superiority , double-blind , placebo-controlled , randomized clinical trial .


The eligibility criteria are as follows : ( @ ) a Chagas disease diagnosis confirmed by serology ; ( @ ) segmental , mild or moderate global left ventricular systolic dysfunction ; and ( @ ) age between @ and @ years .


The exclusion criteria are as follows : ( @ ) pregnancy , ( @ ) diabetes mellitus , ( @ ) tobacco use , ( @ ) alcohol abuse , ( @ ) evidence of nonchagasic heart disease , ( @ ) depression , ( @ ) dysphagia with evidence of food residues in the esophagus , ( @ ) dysphagia with weight loss higher than @ % of usual weight in the last four months and/or ( @ ) conditions that may result in low protocol adherence .


The intervention will be @ g of sodium selenite once daily for @ consecutive days compared to placebo .


The following are the primary outcomes to be measured : ( @ ) the trajectories of the left ventricular ejection fraction in the follow-up period ; ( @ ) reduction of heart disease progression rates , with progression defined as a @ % decrease in left ventricular ejection fraction ; and ( @ ) rate of hospital admissions attributable to dysrhythmia , heart failure or stroke due to Chagas disease .


One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of @:@ .


The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes .


Both patients and health-care providers will remain blinded to the intervention groups during the @ years of follow-up .


If Se treatment reduces the progression of Chagas cardiopathy , the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost .


To study whether @-Hz stimulation , compared with routine @ Hz , improves swallowing function and freezing of gait ( FOG ) in patients with Parkinson disease ( PD ) who undergo bilateral subthalamic nucleus ( STN ) deep brain stimulation ( DBS ) .


We studied @ patients with PD who experienced FOG that persisted despite routine @-Hz stimulation and dopaminergic medication .


Each patient received @ modified barium swallow ( MBS ) studies in a single day under @ DBS conditions in the medication-on state : @ Hz , @ Hz , or DBS off , in a randomized double-blind manner .


The laryngeal penetration and aspiration events were cautiously assessed , and a swallowing questionnaire was completed .


The Unified Parkinson 's Disease Rating Scale , Part III motor score , axial subscore , tremor subscore , and FOG by a questionnaire and stand-walk-sit test were also assessed .


The best DBS condition ( @ Hz here ) producing the least FOG was maintained for @ to @ weeks , and patients were assessed again .


Changes in measurements between the @ Hz and @ Hz were analyzed using paired t test , with swallowing function as primary and the remainder as secondary outcomes .


Changes between other DBS conditions were further explored with Bonferroni correction .


Compared with the routine @ Hz , @-Hz stimulation significantly reduced aspiration frequency by @ % on MBS study and perceived swallowing difficulty by @ % on questionnaire .


It also significantly reduced FOG , and axial and parkinsonian symptoms .


The benefits at @-Hz stimulation persisted over the average @-week assessment .


Compared with the routine @ Hz , the @-Hz stimulation significantly improved swallowing function , FOG , and axial and parkinsonian symptoms in patients with PD treated with bilateral STN-DBS , which persisted over the @-week study period .


This study provides Class IV evidence that for patients with PD who experience FOG , STN-DBS at @ Hz decreases aspiration events observed during MBS compared with DBS at @ Hz .


This study aims to assess the endometrial safety of ospemifene based on phase @/@ clinical trials of postmenopausal women with up to @ weeks of exposure to ospemifene @ mg/day versus placebo .


Endometrial safety was evaluated in a development program of six randomized , double-blind , placebo-controlled , parallel-group studies of postmenopausal women aged between @ and @ years who had vulvar and vaginal atrophy .


Participants were randomized @:@ to ospemifene @ mg/day or placebo in one @-week trial and three @-week trials ; one of the @-week trials had a @-week extension study .


In a separate @-week trial , women were randomized @:@ to ospemifene @ mg/day or placebo .


Endometrial safety was assessed by endometrial histology ( biopsy ) , transvaginal ultrasound , and gynecologic examination .


In these trials , @,@ women who received ospemifene @ mg/day and @ women who received placebo were evaluable for safety .


Endometrial hyperplasia occurred in less than @ % of women treated with ospemifene ; no endometrial cancer was reported .


The mean ( SD ) increase in endometrial thickness among women treated with ospemifene was @ ( @ ) mm at @ weeks , @ ( @ ) mm at @ months , and @ ( @ ) mm at @ months .


Women who received placebo had a mean ( SD ) increase of @ ( @ ) mm at @ months .


These clinical trial data indicate that up to @ weeks of treatment with oral ospemifene @ mg/day was safe for the endometrium .


There was no increase in the incidence of endometrial cancer or hyperplasia among postmenopausal women treated with ospemifene compared with placebo .


We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus ( HV ) used in Norway , Mitchell 's osteotomy ( MO ) and chevron osteotomy ( CO ) .


One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. .


All operative procedures were performed with ankle block and with tourniquet applied .


None of the patients received any antibiotic or antithrombotic prophylaxis .


The follow-up period was @ years .


Clinical results were rated according to the American Orthopaedic Foot and Ankle Society ( AOFAS ) Clinical Rating System ( CRS ) .


HV in the MO group was reduced from @ ( range , @ to @ ) to @ ( range , @ to @ ) degrees and IM angle from @ ( range , @ to @ ) to @ ( range , @ to @ ) degrees .


HV in the CO group was reduced from @ ( range , @ to @ ) to @ ( range , @ to @ ) degrees and IM angle from @ ( range , @ to @ ) to @ ( range , @ to @ ) degrees .


Transfer metatarsalgia occurred in @ ( @ % ) patients and hammertoe in @ ( @ % ) patients in the MO group .


In the CO group , metatarsalgia occurred in @ patients .


The median loss of postoperative HV correction was @ ( range , @ to @ ) degrees in mild deformity and @ ( @ to @ ) degrees in moderate deformity .


Patients treated with CO had significantly better results for AOFAS CRS , number of postoperative complications , patient satisfaction , and length of sick leave for the employed patients .


Based on our results , we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV .


Level I , prospective randomized study .


Comorbidities are frequent in heart failure and impact outcomes .


It is not known whether comorbidities are associated with outcomes in asymptomatic left ventricular dysfunction compared to clinical heart failure and whether comorbidities interfere with treatment effects .


Our objective was to assess comorbidities and their effects on outcomes in predominantly asymptomatic populations without previous heart failure treatment of the SOLVD prevention trial , compared to symptomatic heart failure patients of SOLVD treatment and to evaluate associations to the effect of enalapril .


This post hoc analysis from the SOLVD prevention and SOLVD treatment trials includes @ patients with left ventricular dysfunction and @ patients with heart failure .


The preexisting comorbidities hypertension , diabetes mellitus , pulmonary disease , angina pectoris , renal impairment , and anaemia were similar in SOLVD treatment and SOLVD prevention , with a higher prevalence in SOLVD treatment .


Comorbidities are significantly associated with the primary composite of SOLVD time to death or heart failure hospitalization ( SOLVD prevention : HR @ , CI : @-@ @ , P < @ ; SOLVD treatment : HR @ , CI : @-@ @ , P < @ for more than four comorbidities vs. no comorbidities ) , and to death , heart failure hospitalization , and cardiovascular death where the effect of the number of coexisting comorbidities was additive .


There was no significant interaction of comorbidities with treatment effects of enalapril .


Comorbidities increased events in asymptomatic left ventricular dysfunction and in symptomatic heart failure , but did not interfere with the effects of enalapril .


Comorbidities need to be adequately addressed in clinical trials , which should also involve non-cardiac treatments in order to improve outcome for heart failure patients .


The goal of this study was to report the results of selective open reduction and internal fixation of fractures of the posterior malleolus with a posterolateral approach and to compare the results of the @ techniques .


We prospectively evaluated @ patients who underwent posterior malleolar fracture fixation between @ and @ .


The patients were treated with a posterolateral approach .


We assigned alternating patients to receive plate fixation and the next screw fixation , consecutively , based on the order in which they presented to our institution .


Fixation of the posterior malleolus was made with lag screws in @ patients and a buttress plate in @ patients .


We used American Orthopaedic Foot and Ankle Society ( AOFAS ) scores , range of motion ( ROM ) of the ankle , and radiographic evaluations as the main outcome measurements .


The mean follow-up was @ ( range , @-@ ) months .


Full union without any loss of reduction was obtained in @ of the @ patients .


We detected a union with a step-off of @ mm in @ patient in the screw group and a step-off of @ mm in @ patient in the plate group .


At the final follow-up , the mean AOFAS score of the patients regardless of fixation type was @ ( range , @-@ ) .


The statistical results showed no significant difference between the patients regardless of the fixation type of the posterior malleolus in terms of AOFAS scores and ROM of the ankle ( P > @ ) .


Good ( AOFAS score of @/@ ) and equivalent ( within @ points ) results were obtained using the @ techniques ( screws or plate ) for fixation after open reduction of posterior malleolar fragments .


Level II , prospective case series .


This study reports the impact of cardiac resynchronization therapy ( CRT ) on hospitalizations in patients randomized to implantable cardioverter-defibrillator ( ICD ) or ICD-CRT in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial ( RAFT ) .


Hospitalization rates and lengths of hospital stay were compared between the @ groups .


At the @-month follow-up , the numbers of patients hospitalized for any cause were similar in the ICD ( n = @ , @ % ) and ICD-CRT ( n = @ , @ % ) groups .


The number of patients hospitalized for heart failure was significantly lower in the ICD-CRT ( n = @ , @ % ) compared with the ICD ( n = @ , @ % ; P = @ ) group .


The number of patients hospitalized for a device-related indication was similar in the ICD-CRT group ( n = @ , @ % ) and ICD group ( n = @ , @ % ; P = @ ) .


The total number of hospitalizations for any cause ( n = @ versus n = @ ; P = @ ) , any cardiovascular cause ( n = @ versus n = @ ; P = @ ) , and any heart failure cause ( n = @ versus n = @ ; P < @ ) was significantly lower in ICD-CRT group compared with the ICD group , whereas the number of hospitalizations for device-related causes was significantly higher in the ICD-CRT group compared with the ICD group ( @ versus @ ; P < @ ) .


Although the reduction in hospitalizations for heart failure in the CRT-ICD group was offset by an increased number of hospitalizations for device-related indications , the length of hospital stay for any cause was significantly shorter in the ICD-CRT group ( @ days ) compared with the ICD group ( @ days ; P = @ ) .


ICD-CRT therapy significantly reduces hospitalizations and total days in hospital in patients with New York Heart Association class II/III heart failure compared with ICD therapy despite increased admissions for device-related indications .


BMT CTN @ is a Phase III randomized controlled trial evaluating the comparative effectiveness of double unrelated umbilical cord blood ( dUCB ) versus HLA-haploidentical related donor bone marrow ( haplo-BM ) donor cell sources for blood or bone marrow transplantation ( BMT ) in patients with hematologic malignancies .


Herein , we present the rationale , design and methods of the first cost-effectiveness analysis to be conducted alongside a BMT trial .


Consenting patients will provide health insurance information to allow calculation of direct medical costs from reimbursement records , and will provide out-of-pocket costs , time costs and health-related quality of life measures through an online survey .


These outcomes will inform a cost-effectiveness analysis comparing dUCB and haplo-BM donor cell sources from patient , payer and societal perspectives .


Novel approaches may significantly change the cost , outcomes or availability of BMT .


The results of this analysis will be the first to provide a comprehensive evaluation of the comparative effectiveness of these approaches from multiple perspectives .


Although hypercholesterolemia is considered a cardiovascular risk factor , in isolation it is not necessarily sufficient cause for a cardiovascular event .


To improve event prediction , cardiovascular risk calculators have been developed ; the REGICOR calculator has been validated for use in our population .


The objective of this project is to develop an intervention with general practitioners ( GPs ) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease .


This nonblinded , cluster-randomized clinical trial analyzes data from primary care electronic medical records ( ECAP ) and other databases .


Inclusion criteria are patients aged @ to @years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the @-year study period .


Dependent variables include the following : RETIRA , defined as new cholesterol-lowering drugs initiated during the year preceding the intervention , considered inadequate , and withdrawn during the study period ; EVITA , defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate ; COST , defined as the total cost of inadequate new treatments prescribed ; and REGISTER , defined as the recording of cardiovascular risk factors .


Independent variables include the GP 's quality-of-care indicators and randomly assigned study group ( intervention vs control ) , patient demographics , and clinical variables .


Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect , adjusted for individual and GP variables .


The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care .


The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention .


Increased brain atrophy rates are common in older people with cognitive impairment , particularly in those who eventually convert to Alzheimer disease .


Plasma concentrations of omega-@ ( -@ ) fatty acids and homocysteine are associated with the development of brain atrophy and dementia .


We investigated whether plasma -@ fatty acid concentrations ( eicosapentaenoic acid and docosahexaenoic acid ) modify the treatment effect of homocysteine-lowering B vitamins on brain atrophy rates in a placebo-controlled trial ( VITACOG ) .


This retrospective analysis included @ elderly people ( @ y ) with mild cognitive impairment , randomly assigned either to placebo ( n = @ ) or to daily high-dose B vitamin supplementation ( folic acid , @ mg ; vitamin B-@ , @ mg ; vitamin B-@ , @ mg ) ( n = @ ) .


The subjects underwent cranial magnetic resonance imaging scans at baseline and @ y later .


The effect of the intervention was analyzed according to tertiles of baseline -@ fatty acid concentrations .


There was a significant interaction ( P = @ ) between B vitamin treatment and plasma combined -@ fatty acids ( eicosapentaenoic acid and docosahexaenoic acid ) on brain atrophy rates .


In subjects with high baseline -@ fatty acids ( > @ mol/L ) , B vitamin treatment slowed the mean atrophy rate by @ % compared with placebo ( P = @ ) .


B vitamin treatment had no significant effect on the rate of atrophy among subjects with low baseline -@ fatty acids ( < @ mol/L ) .


High baseline -@ fatty acids were associated with a slower rate of brain atrophy in the B vitamin group but not in the placebo group .


The beneficial effect of B vitamin treatment on brain atrophy was observed only in subjects with high plasma -@ fatty acids .


It is also suggested that the beneficial effect of -@ fatty acids on brain atrophy may be confined to subjects with good B vitamin status .


The results highlight the importance of identifying subgroups likely to benefit in clinical trials .


This trial was registered at www.controlled-trials.com as ISRCTN@ .


There are some clinical trials showing that short-term ischemia in one organ can protect different organs against higher intensity and longer ischemic insult .


We designed a study to assess whether remote ischemic preconditioning ( RIPC ) on one organ can decrease the rate of contrast-induced acute kidney injury ( AKI ) in diabetic patients who undergo coronary artery angiography ( CAA ) .


This randomized control trial included @ diabetic patients who were candidates for CAA .


Exclusion criteria were congestive heart failure and complications during CAA .


All of the patients received @ mL of normal saline before CAA .


The RIPC group underwent @ cycles of @-minute ischemia in their right arm .


Serum creatinine was measured before and @ hours after CAA .


Contrast-induced AKI was reported in @ cases in the control group and @ case in the RIPC group ( P = @ , odds ratio , @ ) .


The differences in serum creatinine level before and after the procedure was significantly lower in RIPC group than that in the control group ( P = @ , odds ratio , @ ) .


Serum creatinine rise significantly correlated with contrast dose ( P = @ ) and a history of hypertension ( P = @ ) in both groups .


Ischemic preconditioning had a protective effect on contrast-induced AKI in our study .


Since this method is harmless and cost effective , further studies on patients with chronic kidney disease is required to evaluate addition of ischemic preconditioning to our clinical practice for prevention of contrast-induced AKI .


Cardiovascular diseases ( CVDs ) are an increasing health problem all over the world .


The search for natural hypolipidemic agents that can be used besides the synthetic drugs is still in its experimental stage .


Plant seeds , particularly flaxseed ( Linum usitatissimum ) , which is a rich source of n-@ fatty acids , lignans and phenolic compounds , have also received increasing attention for their potential role in preventing lipid disorders .


The present study was undertaken to evaluate the therapeutic potential of flaxseeds in dyslipidemia .


The study included @ dyslipidemic subjects selected by purposive random sampling and were divided into two groups , a control and an experimental group .


Both the groups were prescribed similar dietary guidelines .


Subjects in the experimental group received @ g of roasted flaxseed powder for @ months .


Anthropometric parameters , blood pressure , and blood lipid profile were estimated before the study and after completion of the study .


Flaxseed supplementation resulted in a remarkable improvement in anthropometric measurements , blood pressure , and lipid profile in the experimental group .


Body weight and body mass index ( BMI ) of the experimental group were significantly reduced ( p < @ ) .


A lowering of systolic and diastolic blood pressure ( p < @ ) was also recorded in the dyslipidemic subjects .


Concomitantly , a highly significant reduction ( p < @ ) in total cholesterol , triglycerides , low density lipoprotein-cholesterol ( LDL-C ) , and very low density lipoprotein-cholesterol ( VLDL-C ) levels , with simultaneous elevation ( p < @ ) in high density lipoprotein-cholesterol ( HDL-C ) levels was observed .


Improvement in lipid levels resulted in reduction of atherogenic indices .


The supplementation of roasted flaxseed powder for @ months improved the BMI , blood pressure , and lipid profile of dyslipidemic subjects , thus exhibiting cardio protective effect .


In the Iressa Pan-ASia Study ( IPASS ) , gefitinib claimed improved progression-free survival ( PFS ) versus carboplatin-paclitaxel in clinically selected lung cancer patients .


The primary objective of this study was to assess the PFS of pemetrexed-cisplatin ( PC ) followed by gefitinib maintenance versus gefitinib monotherapy in an IPASS-like population .


In this open-label , randomised , phase @ trial , eligible patients were @ years , chemonave , East Asian , light ex-smokers/never-smokers with advanced non-squamous non-small cell lung cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status @-@ and unknown epidermal growth factor receptor ( EGFR ) mutation status who enrolled at @ sites in Asia .


Patients randomly received ( @:@ ) pemetrexed ( @ mg/m ( @ ) ) plus cisplatin ( @mg/m ( @ ) ) for six @-day cycles , followed by gefitinib maintenance or gefitinib monotherapy ( @ mg/day ) .


Patient tissue was retrospectively analysed for EGFR mutations .


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


Between @rd November @ and @th April @ , @ patients entered , and @ patients were randomly assigned to and treated with PC therapy ( N = @ ) and gefitinib monotherapy ( N = @ ) .


Between-arm baseline characteristics were balanced .


PFS was not significantly different between treatment arms ( p = @ ) .


The unadjusted hazard ratio ( HR ) was @ ( @ % confidence interval ( CI ) @-@ @ ) .


The HR should be cautiously interpreted as it was not constant .


EGFR mutation status was determined for @ tissue samples ; @ ( @ % ) had mutations .


In a pre-specified subgroup analysis , only the treatment-by-EGFR mutation interaction was significant ( p = @ ) for PFS .


For the entire treatment period , a higher proportion of patients in the PC/gefitinib arm versus gefitinib experienced possibly drug-related grade @-@ treatment-emergent adverse events ( @ of @ -LSB- @ % -RSB- versus @ of @ -LSB- @ % -RSB- ; p = @ ) .


In the intention-to-treat ( ITT ) population , PFS was not significantly different .


In the biomarker-assessable population , front-line EGFR tyrosine kinase inhibitor monotherapy was not efficacious in patients with wild-type EGFR .


Identification of EGFR mutation status is key in the management of advanced non-squamous non-small cell lung cancer .


To determine whether EMD @ , a TLR@ agonist , added to cetuximab had antitumor activity in second-line recurrent/metastatic squamous cell carcinoma of the head and neck ( R/M SCCHN ) .


This was a phase @ , open-label , randomized trial of EMD @ @ mg/kg subcutaneously weekly plus cetuximab ( combination ) vs cetuximab monotherapy ( control ) in cetuximab-nave patients with R/M SCCHN who progressed on @ cytotoxic regimen .


Crossover to combination was permitted after progression .


Objective response rate in both arms was @ % ( @ % CI @-@ @ % ) by independent assessment .


Disease control was @ % for patients on combination ( @-@ @ % ) and @ % on control ( @-@ @ % ) .


Neither independent nor investigator assessments showed significant differences between study arms .


Median progression-free survival was @ months ( @-@ @ ) for patients on combination , and @ months ( @-@ @ ) on control .


The most frequent adverse events in the combination arm were rash ( @ % ) , acneiform dermatitis ( @ % ) , and injection site reactions ( @ % ) .


Grade @/@ dyspnea and hypokalemia were more frequent with cetuximab monotherapy ( @ % and @ % vs @ % each , respectively ) , and grade @/@ respiratory failure and disease progression were more frequent with combination ( @ % each vs @ % each ) .


EMD @ was well tolerated combined with cetuximab , but there was no incremental clinical efficacy .


Mammography screening can reduce breast cancer mortality .


However , most women are unaware that inconsequential disease can also be detected by screening , leading to overdiagnosis and overtreatment .


We aimed to investigate whether including information about overdetection of breast cancer in a decision aid would help women aged around @ years to make an informed choice about breast screening .


We did a community-based , parallel-group , randomised controlled trial in New South Wales , Australia , using a random cohort of women aged @-@ years .


Recruitment to the study was done by telephone ; women were eligible if they had not had mammography in the past @ years and did not have a personal or strong family history of breast cancer .


With a computer program , we randomly assigned @ participants to either the intervention decision aid ( comprising evidence-based explanatory and quantitative information on overdetection , breast cancer mortality reduction , and false positives ) or a control decision aid ( including information on breast cancer mortality reduction and false positives ) .


Participants and interviewers were masked to group assignment .


The primary outcome was informed choice ( defined as adequate knowledge and consistency between attitudes and screening intentions ) , which we assessed by telephone interview about @ weeks after random allocation .


The primary outcome was analysed in all women who completed the relevant follow-up interview questions fully .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


Between January , @ , and July , @ , @ women were allocated to the intervention group and @ were assigned to the control group .


@ women in the intervention group and @ controls were lost to follow-up ; a further ten women assigned to the intervention and @ controls did not answer all questions on attitudes .


Therefore , @ women in the intervention group and @ controls were analysed for the primary outcome .


@ ( @ % ) of @ women in the intervention group made an informed choice compared with @ ( @ % ) of @ in the control group ( difference @ % , @ % CI @-@ ; p = @ ) .


Compared with controls , more women in the intervention group met the threshold for adequate overall knowledge ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ; difference @ % , @ % CI @-@ ; p < @ ) , fewer women expressed positive attitudes towards screening ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ; @ % , @-@ ; p < @ ) , and fewer women intended to be screened ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ; @ % , @-@ ; p < @ ) .


When conceptual knowledge alone was considered , @ ( @ % ) of @ women in the intervention group made an informed choice compared with @ ( @ % ) of @ in the control group ( p < @ ) .


Information on overdetection of breast cancer provided within a decision aid increased the number of women making an informed choice about breast screening .


Becoming better informed might mean women are less likely to choose screening .


Vaccine efficacy ( VE ) against vulvar human papillomavirus ( HPV ) infection has not been reported and data regarding its epidemiology are sparse .


Women ( n = @ ) age @-@ present at the @-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples .


A subset ( n = @ ) was tested for HPV DNA ( SPF@/LiPA@ version @ ) .


VE against @-time detection of vulvar HPV@/@ among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix .


Prevalence of and risk factors for HPV were evaluated in the control arm ( n = @ ) .


Vulvar HPV@/@ VE ( @ % ; @ % confidence interval -LSB- CI -RSB- , @ % -@ % ) was comparable to cervix ( @ % ; @ % CI , @ % -@ % ) .


Vulvar and cervical HPV@ prevalence within the control arm was @ % and @ % , respectively .


Independent risk factors for vulvar HPV were similar to cervix and included : age ( adjusted odds ratio -LSB- aOR -RSB- @ -LSB- @ % CI , @ -@ -RSB- @ vs @-@ -RSB- ) ; marital status ( aOR @ -LSB- @ % CI , @-@ @ -RSB- single vs married/living-as-married ) ; and number of sexual partners ( aOR @ -LSB- @ % CI , @-@ @ -RSB- @ vs @ ) .


In this intention-to-treat analysis , VE against vulvar and cervical HPV@/@ were comparable @ years following vaccination .


Risk factors for HPV were similar by anatomic site .


Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage .


These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques .


The Pragmatic Randomized Optimal Platelet and Plasma Ratios ( PROPPR ) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products .


This report describes the design and implementation of PROPPR .


PROPPR was designed as a randomized , two-group , Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion .


Subjects at @ North American level @ trauma centres were randomized into one of two standard transfusion ratio interventions : @:@:@ or @:@:@ , ( plasma , platelets , and red blood cells ) .


Clinical data and serial blood samples were collected under Exception from Informed Consent ( EFIC ) regulations .


Co-primary mortality endpoints of @h and @ days were evaluated .


Between August @ and December @ , @ patients were randomized .


The overall median time from admission to randomization was @min .


PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations .


PROPPR is the largest randomized study to enrol severely bleeding patients .


This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible .


PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies .


The benefits of medication adherence to control cardiovascular disease ( CVD ) are well defined , yet multiple studies have identified poor adherence .


The influence of life chaos on medication adherence is unknown .


Because this is a novel application of an instrument , our preliminary objective was to understand patient factors associated with chaos .


The main objective was to evaluate the extent to which an instrument designed to measure life chaos is associated with CVD-medication nonadherence .


Using baseline data from an ongoing randomized trial to improve postmyocardial infarction ( MI ) management , multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence .


Patients had hypertension and a myocardial infarction in the past @ years ( n = @ ) .


Nearly @ % reported CVD-medication nonadherence in the past month .


In simple linear regression , the following were associated with higher life chaos : medication nonadherence ( = @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , female sex ( = @ ; @ % CI -LSB- @-@ @ -RSB- ) , minority race ( = @ ; @ % CI -LSB- @-@ @ -RSB- ) , having less than high school education ( = @ ; @ % CI -LSB- @-@ @ -RSB- ) , low health literacy ( = @ ; @ % CI -LSB- @-@ @ -RSB- ) , and inadequate financial status ( = @ ; @ % CI -LSB- @-@ @ -RSB- ) .


Being married ( = -@ , @ % CI -LSB- -@ to -@ -RSB- ) was associated with lower life chaos .


As chaos quartile increased , patients exhibited more nonadherence .


In logistic regression , adjusting for sex , race , marital status , employment , education , health literacy , and financial status , a @-unit life chaos increase was associated with a @ % increase ( odds ratio , @ ; @ % CI -LSB- @-@ @ -RSB- ) in odds of reporting medication nonadherence .


Our results suggest that life chaos may be an important determinant of medication adherence .


Life chaos screenings could identify those at risk for nonadherence .


The principal study objective was to investigate the pharmacokinetic characteristics of a new sublingual ketamine wafer and to establish its absolute bioavailability and local tolerability .


The study was of open label , two way randomized crossover design in eight healthy male volunteers .


Each participant received either a single @ mg intravenous dose as a constant rate @ min infusion or a @mg sublingual dose of ketamine wafer in two treatment periods with a @ day wash out .


Pharmacokinetic blood sampling and local tolerability and safety assessments were carried out during @ h following both dosing occasions .


Plasma concentrations were analyzed by non-compartmental methods and local tolerability was assessed using modified Likert scales .


The median ( @ % CI lower , upper limit ) absolute bioavailability of sublingual ketamine was @ % ( @ , @ % ) .


The first quantifiable plasma ketamine concentration was observed within @ min for all eight participants for both routes of administration and the median ( minmax ) time of the peak plasma concentration was @ h ( @ h ) after sublingual administration .


The ketamine wafer had very good local tolerability .


Sublingual administration of the ketamine wafer resulted in rapid absorption .


The ketamine wafer has comparable bioavailability with other oral transmucosal formulations of ketamine but with markedly reduced inter-subject variability , warranting further evaluation as an analgesic adjunct .


Many patients with chronic kidney disease ( CKD ) are hyporesponsive to currently licensed alum-adjuvanted hepatitis B vaccines , including Engerix-B ( ) ( HBsAg-Eng ) .


Seroprotection rates ( SPRs ) are further reduced in CKD patients with diabetes mellitus .


Three doses of an investigational hepatitis B vaccine ( HBsAg-@ ) that uses a Toll-like receptor @ agonist demonstrated superior SPRs to @ double doses of HBsAg-Eng in a large phase @ trial of CKD patients .


A prespecified subgroup analysis of immunogenicity was conducted in CKD participants with type @ diabetes in the phase @ trial .


In @ participants , the peak SPR in the HBsAg-@ group met criteria for noninferiority and superiority to the peak SPR in the HBsAg-Eng group .


The peak geometric mean concentration of antibody against hepatitis B surface antigen in the HBsAg-@ group was statistically significantly higher than in the HBsAg-Eng group .


HBsAg-@ induced significantly higher seroprotection than HBsAg-Eng in CKD patients with diabetes .


Autologous blood transfusion from the placenta to the neonate at birth has been proven beneficial .


Transfusion can be accomplished by either delayed cord clamping or cord stripping .


Both are equally effective in previous randomized trials .


We hypothesized that combining these @ techniques would further improve outcomes in preterm neonates .


This was a prospective randomized trial for singleton deliveries with estimated gestational ages between @ and @@/@ weeks .


The control protocol required a @-second delayed cord clamping , whereas the test protocol instructed a concurrent cord stripping during the delay .


The primary outcome was initial fetal hematocrit .


We also examined secondary outcomes of neonatal mortality , length of time on the ventilator , days to discharge , peak bilirubin , number of phototherapy days , and neonatal complication rates .


Of the @ patients analyzed , @ were randomized to the control arm and @ were randomized to the test arm .


The gestational ages and fetal weights were similar between the arms .


Mean hematocrit of the control arm was @ % , and the mean hematocrit for the test arm was @ % ( P = @ ) .


These results were stratified by gestational age , revealing the infants less than @ weeks had an average hematocrit of @ % in the control arm and @ % in the test arm ( P = @ ) .


In the infants with gestational ages of @ weeks or longer , the control arm had an average hematocrit of @ % , which was higher than the test arm , which averaged @ % ( P = @ ) .


The control arm received an average of @ blood transfusions , whereas the test arm received @ ( P = @ ) .


The control arm had @ neonatal deaths , and the test arm had none ( P = @ ) .


The average number of days until discharge was @ for the control arm and @ for the test arm ( P = @ ) .


The average number of days on the ventilator was @ for the control arm and @ for the test arm ( P = @ ) .


Adding cord stripping to the delayed cord clamp does not result in an increased hematocrit .


Data suggest trends in lower mortality and higher hematocrit in neonates born less than @ weeks , but these were not statistically significant .


Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention ( PCI ) .


This study aimed to elucidate the relative efficacy of everolimus-eluting stents ( EES ) versus sirolimus-eluting stents ( SES ) according to diabetic status .


Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner .


The primary endpoint was target lesion failure ( TLF ) , a composite of cardiac death , target vessel-related myocardial infarction , or target vessel revascularisation .


Among a total of @,@ patients , @,@ ( @ % ) had diabetes mellitus .


Patients with diabetes were shown to have a higher rate of TLF after PCI , which was mainly driven by differences in cardiac death and myocardial infarction , while the rate of repeat revascularisation and stent thrombosis did not differ significantly .


TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status ( interaction p = @ ) .


In addition , no significant interactions were present with regard to any pre-specified clinical endpoints .


The results were corroborated by analysis with inverse probability of treatment weighting ( interaction p = @ ) .


We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI .


Despite the recent advances in drug-eluting stent technology , diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus .


Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI .


To evaluate the effectiveness of an interactive videogame ( IV ) system in addition to a supervised pulmonary rehabilitation programme ( PRP ) in patients with chronic respiratory diseases .


Randomised Controlled Trial comparing standard PRP ( @ patients , control group : CG ) , and PRP + sessions of interactive videogame-aided exercises ( @ patients , experimental group : EG ) .


Lung and respiratory muscle function , arterial blood gases , exercise capacity , dyspnoea , health status and health-related quality of life ( HRQL ) and emotional response were measured before and after PRP .


A questionnaire on acceptability of the PRP was administered .


Exercise capacity , dyspnoea and HRQL significantly improved in both groups after the PRP , whereas the EG showed a greater improvement in six-minute walk test and transitional dyspnoea index than the CG .


No difference in psychological status or acceptability of PRP was observed between the two groups .


The addition of IV training was more effective for improving some parameters of exercise tolerance and dyspnoea , although did not result in better psychological status nor it was better accepted than the standard PRP in patients with chronic respiratory diseases .


High attendance rates in cervical screening are essential for effective cancer prevention .


Offering HPV self-sampling to non-responders increases participation rates .


The objectives of this study were to determine why non-responders do not attend regular screening , and why they do or do not participate when offered a self-sampling device .


A questionnaire study was conducted in the Netherlands from October @ to December @ .


A total of @,@ non-responders were invited to participate in an HPV self-sampling study ; @ women did opt out .


Finally , @,@ women received a questionnaire and self-sampling device .


The analysis was based on @ returned questionnaires ( @ % ) with a self-sample specimen , and @ ( @ % ) without .


Among women who returned both , the main reason for non-attendance to cervical screening was that they forgot to schedule an appointment ( @ ; @ % ) .


The most important reason to use the self-sampling device was the opportunity to take a sample in their own time-setting ( @ ; @ % ) .


A total of @ % of the women who did not use the self-sampling device preferred after all to have a cervical smear taken instead .


Organisational barriers are the main reason for non-attendance in regular cervical screening .


Important reasons for non-responders to the regular screening to use a self-sampling device are convenience and self-control .


Myocardial injury commonly occurs during percutaneous coronary intervention ( PCI ) .


Several agents that mimic ischemic preconditioning could help minimize this phenomenon .


This study evaluated the cardio-protective role of intracoronary Adenosine in elective PCI .


A total of @ diabetic patients with chronic stable angina were prospectively enrolled , then randomly assigned to undergo PCI with intracoronary Adenosine ; @ g/stented vessel ( group-A , @ patients ) or standard PCI ( group-B , @ patients ) .


Cardiac troponin I ( cTnI ) and creatine kinase-MB ( CK-MB ) levels were measured before and @ , @ and @ hours post-PCI .


Mean age of the study cohort was @ years ( males = @ % ) .


cTnI level was significantly lower in group-A ( @ hours : @ vs. @ pg/mL , @ hours : @ vs. @ pg/mL and @ hours : @ vs. @ pg/mL , P < @ ) .


After @ months , the same group showed significantly higher left ventricle ejection fraction ( LVEF % ) , i.e. @ vs. @ ( P < @ ) .


There was no statistically significant difference between both groups of patients regarding incidence of major adverse cardiac events ( MACE ) .


In diabetic patients undergoing elective PCI , intracoronary Adenosine was associated with decreased incidence of PCI-related myocardial injury & improvement of LVEF % after @ months .


Since probiotics modulate intestinal functions and enterohepatic circulation ; they might have an effect on neonatal hyperbilirubinemia treatment .


The objective of this study was to investigate the efficacy of Saccharomyces boulardii supplementation on hyperbilirubinemia .


A prospective , double-blind , placebo controlled trial was performed on @ to @ gestational weeks ' neonates .


They were randomized either to receive feeding supplementation with S. boulardii @mg every @ hours or placebo during phototherapy .


Serum bilirubin levels were measured at @ , @th , @th , @nd , and @th hour of phototherapy .


A total of @ infants ( @ in the control group and @ in the study group ) were enrolled .


The duration of phototherapy ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- , p : @ ) was not different between groups .


The levels of bilirubin during phototherapy ( -LSB- @th hour ; @ -LCB- @-@ @ -RCB- vs. @ -LCB- @-@ @ -RCB- , p : @ -RSB- ; -LSB- @th hour ; @ -LCB- @-@ @ -RCB- vs. @ -LCB- @-@ @ -RCB- , p : @ -RSB- ; -LSB- @nd hour ; @ -LCB- @-@ @ -RCB- vs. @ -LCB- @-@ @ -RCB- , p : @ -RSB- ; -LSB- @th hour ; @ -LCB- @-@ @ -RCB- vs. @ -LCB- @-@ @ -RCB- , p : @ -RSB- ) or the duration of rebound phototherapy ( @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- , p : @ ) were lower in the study group than in the controls , but none of the values were statistically significant .


S. boulardii did not influence the clinical course of hyperbilirubinemia significantly .


This study sought to investigate the impact of left main coronary artery ( LMCA ) @-dimensional ( @D ) bifurcation angle ( BA ) parameters on @-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention ( PCI ) in the SYNTAX ( Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery ) trial .


BA can affect outcome after bifurcation PCI ; @D angiographic analysis provides reliable BA measurements .


The diastolic distal BA ( between left anterior descending and left circumflex ) and its systolic-diastolic range were explored .


A stratified post-hoc survival analysis was performed for @-year major adverse cardiac and cardiovascular events ( MACCE ) ( all-cause death , cerebrovascular accident , myocardial infarction , or repeat revascularization ) , a safety endpoint ( all-cause death , cerebrovascular accident , or myocardial infarction ) , and repeat revascularization .


Analysis was performed in patients where @D BA was available pre - and post-PCI .


Of @ patients eligible for analysis , @ underwent bifurcation PCI ( group B ) ; @ stent was used in @ patients ( group B@ ) , whereas @ stents were used in @ patients ( group B@ ) .


Stratification across pre-PCI diastolic distal BA tertiles ( < @ , @ to @ , @ ) failed to show any difference in MACCE rates either in the entire study population ( p = @ ) or in group B patients ( p = @ ) .


Group B patients with post-PCI systolic-diastolic range < @ had significantly higher MACCE rates ( @ % vs. @ % , p < @ ) ; repeat revascularization and safety endpoint rates were also higher ( @ % vs. @ % , p = @ , and @ % vs. @ % , p = @ , respectively ) .


Post-PCI systolic-diastolic range < @ was an independent predictor of MACCE ( hazard ratio : @ ; @ % confidence interval : @ to @ ; p < @ ) in group B patients .


A restricted post-procedural systolic-diastolic distal BA range resulted in higher @-year adverse event rates after LMCA bifurcation PCI .


Pre-PCI BA value did not affect the clinical outcome .


To examine with a parallel group study design the performance and physiological responses to a @-day off-season ` live high-train low in the heat ' training camp in elite football players .


Seventeen professional Australian Rules Football players participated in outdoor football-specific skills ( @ @C , @ h ) and indoor strength ( @ @C , @ h ) sessions and slept ( @ nights ) and cycled indoors ( @ h ) in either normal air ( NORM , n = @ ) or normobaric hypoxia ( @ @ h/day , FiO@ @-@ @ % , corresponding to a simulated altitude of @-@ m , hypoxic ( HYP ) , n = @ ) .


They completed the Yo-Yo Intermittent Recovery level @ ( Yo-YoIR@ ) in temperate conditions ( @ @C , normal air ) precamp ( Pre ) and postcamp ( Post ) .