To examine ( 1 ) operational feasibility of the programme ; ( 2 ) participants ' views of the programme ; and ( 3 ) speech intelligibility , communication effectiveness and tongue and lip movement at four points ( A1 and A2 before , and A3 and A4 after intervention ) .


Thirty-nine participants were randomized into Group A ( n = 20 ) and Group B ( n = 19 ) .


Groups were equivalent at enrolment in demographic variables and A1 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 8-week intervals , twice before and twice after intervention .


Anonymous evaluation ( AE ) questionnaires were completed .


The recruited number was 20 % below the target of 50 .


Thirty-six participants completed the intervention and 32 were followed through to A4 .


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 32 participants , 59 % 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 ( A2/A3 ) , which were maintained for 2 months after intervention ( A2/A4 ) .


Non-intervention period changes ( A1/A2 and A3/A4 ) 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 90 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 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter .


Secondary outcome measures are oral tracheal intubation time , days alive outside the intensive care unit , days alive outside the hospital , and 30 - and 90-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 .


ClinicalTrials.gov identifier : NCT01614951 , registered on 6 June 2012 .


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 = 0.60 ; 1 - of 80 % ; = 0.05 ) , 90 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 .


German Clinical Trial Register : DRKS00005223 ( registered on 15 August 2013 ) .


Heart disease progression occurs in 30 % 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 : ( 1 ) a Chagas disease diagnosis confirmed by serology ; ( 2 ) segmental , mild or moderate global left ventricular systolic dysfunction ; and ( 3 ) age between 18 and 65 years .


The exclusion criteria are as follows : ( 1 ) pregnancy , ( 2 ) diabetes mellitus , ( 3 ) tobacco use , ( 4 ) alcohol abuse , ( 5 ) evidence of nonchagasic heart disease , ( 6 ) depression , ( 7 ) dysphagia with evidence of food residues in the esophagus , ( 8 ) dysphagia with weight loss higher than 15 % of usual weight in the last four months and/or ( 9 ) conditions that may result in low protocol adherence .


The intervention will be 100 g of sodium selenite once daily for 365 consecutive days compared to placebo .


The following are the primary outcomes to be measured : ( 1 ) the trajectories of the left ventricular ejection fraction in the follow-up period ; ( 2 ) reduction of heart disease progression rates , with progression defined as a 10 % decrease in left ventricular ejection fraction ; and ( 3 ) 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 1:1 .


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 5 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 .


Clinical Trials.gov ID : NCT00875173 ( registered 20 October 20 2008 ) .


To study whether 60-Hz stimulation , compared with routine 130 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 7 patients with PD who experienced FOG that persisted despite routine 130-Hz stimulation and dopaminergic medication .


Each patient received 3 modified barium swallow ( MBS ) studies in a single day under 3 DBS conditions in the medication-on state : 130 Hz , 60 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 ( 60 Hz here ) producing the least FOG was maintained for 3 to 8 weeks , and patients were assessed again .


Changes in measurements between the 60 Hz and 130 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 130 Hz , 60-Hz stimulation significantly reduced aspiration frequency by 57 % on MBS study and perceived swallowing difficulty by 80 % on questionnaire .


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


The benefits at 60-Hz stimulation persisted over the average 6-week assessment .


Compared with the routine 130 Hz , the 60-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 6-week study period .


This study provides Class IV evidence that for patients with PD who experience FOG , STN-DBS at 60 Hz decreases aspiration events observed during MBS compared with DBS at 130 Hz .


This study aims to assess the endometrial safety of ospemifene based on phase 2/3 clinical trials of postmenopausal women with up to 52 weeks of exposure to ospemifene 60 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 40 and 80 years who had vulvar and vaginal atrophy .


Participants were randomized 1:1 to ospemifene 60 mg/day or placebo in one 6-week trial and three 12-week trials ; one of the 12-week trials had a 40-week extension study .


In a separate 52-week trial , women were randomized 6:1 to ospemifene 60 mg/day or placebo .


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


In these trials , 1,242 women who received ospemifene 60 mg/day and 924 women who received placebo were evaluable for safety .


Endometrial hyperplasia occurred in less than 1 % of women treated with ospemifene ; no endometrial cancer was reported .


The mean ( SD ) increase in endometrial thickness among women treated with ospemifene was 0.51 ( 1.54 ) mm at 12 weeks , 0.56 ( 1.61 ) mm at 6 months , and 0.81 ( 1.54 ) mm at 12 months .


Women who received placebo had a mean ( SD ) increase of 0.07 ( 1.23 ) mm at 12 months .


These clinical trial data indicate that up to 52 weeks of treatment with oral ospemifene 60 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 3 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 30 ( range , 20 to 44 ) to 15 ( range , 8 to 24 ) degrees and IM angle from 11 ( range , 6 to 14 ) to 7 ( range , 4 to 11 ) degrees .


HV in the CO group was reduced from 31 ( range , 22 to 42 ) to 16 ( range , 6 to 24 ) degrees and IM angle from 14 ( range , 8 to 20 ) to 6 ( range , 2 to 10 ) degrees .


Transfer metatarsalgia occurred in 36 ( 60 % ) patients and hammertoe in 6 ( 10 % ) patients in the MO group .


In the CO group , metatarsalgia occurred in 5 patients .


The median loss of postoperative HV correction was 4 ( range , 2 to 10 ) degrees in mild deformity and 6 ( 6 to 10 ) 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 4228 patients with left ventricular dysfunction and 2569 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 4.8 , CI : 3.2-7 .18 , P < 0.0001 ; SOLVD treatment : HR 2.9 , CI : 2.12-3 .95 , P < 0.0001 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 2 techniques .


We prospectively evaluated 40 patients who underwent posterior malleolar fracture fixation between 2008 and 2012 .


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 20 patients and a buttress plate in 20 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 38.2 ( range , 24-51 ) months .


Full union without any loss of reduction was obtained in 38 of the 40 patients .


We detected a union with a step-off of 3 mm in 1 patient in the screw group and a step-off of 2 mm in 1 patient in the plate group .


At the final follow-up , the mean AOFAS score of the patients regardless of fixation type was 94.1 ( range , 85-100 ) .


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 > .05 ) .


Good ( AOFAS score of 94/100 ) and equivalent ( within 3 points ) results were obtained using the 2 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 2 groups .


At the 18-month follow-up , the numbers of patients hospitalized for any cause were similar in the ICD ( n = 351 , 38.8 % ) and ICD-CRT ( n = 331 , 30.0 % ) groups .


The number of patients hospitalized for heart failure was significantly lower in the ICD-CRT ( n = 101 , 11.3 % ) compared with the ICD ( n = 141 , 15.6 % ; P = 0.003 ) group .


The number of patients hospitalized for a device-related indication was similar in the ICD-CRT group ( n = 147 , 16.4 % ) and ICD group ( n = 126 , 13.9 % ; P = 0.148 ) .


The total number of hospitalizations for any cause ( n = 1448 versus n = 1553 ; P = 0.042 ) , any cardiovascular cause ( n = 667 versus n = 790 ; P = 0.017 ) , and any heart failure cause ( n = 385 versus n = 505 ; P < 0.0001 ) 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 ( 246 versus 159 ; P < 0.001 ) .


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 ( 8.8313.30 days ) compared with the ICD group ( 9.5914.40 days ; P = 0.005 ) .


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 .


http://www.clinicaltrials.gov .


Unique identifier : NCT00251251 .


BMT CTN 1101 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 35 to 74years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-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 .


ClinicalTrials.gov Identifier : NCT01997671 .


November 28 , 2013 .


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-3 ( -3 ) fatty acids and homocysteine are associated with the development of brain atrophy and dementia .


We investigated whether plasma -3 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 168 elderly people ( 70 y ) with mild cognitive impairment , randomly assigned either to placebo ( n = 83 ) or to daily high-dose B vitamin supplementation ( folic acid , 0.8 mg ; vitamin B-6 , 20 mg ; vitamin B-12 , 0.5 mg ) ( n = 85 ) .


The subjects underwent cranial magnetic resonance imaging scans at baseline and 2 y later .


The effect of the intervention was analyzed according to tertiles of baseline -3 fatty acid concentrations .


There was a significant interaction ( P = 0.024 ) between B vitamin treatment and plasma combined -3 fatty acids ( eicosapentaenoic acid and docosahexaenoic acid ) on brain atrophy rates .


In subjects with high baseline -3 fatty acids ( > 590 mol/L ) , B vitamin treatment slowed the mean atrophy rate by 40.0 % compared with placebo ( P = 0.023 ) .


B vitamin treatment had no significant effect on the rate of atrophy among subjects with low baseline -3 fatty acids ( < 390 mol/L ) .


High baseline -3 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 -3 fatty acids .


It is also suggested that the beneficial effect of -3 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 ISRCTN94410159 .


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 96 diabetic patients who were candidates for CAA .


Exclusion criteria were congestive heart failure and complications during CAA .


All of the patients received 1000 mL of normal saline before CAA .


The RIPC group underwent 3 cycles of 5-minute ischemia in their right arm .


Serum creatinine was measured before and 24 hours after CAA .


Contrast-induced AKI was reported in 5 cases in the control group and 1 case in the RIPC group ( P = .13 , odds ratio , 5.4 ) .


The differences in serum creatinine level before and after the procedure was significantly lower in RIPC group than that in the control group ( P = .04 , odds ratio , 0.08 ) .


Serum creatinine rise significantly correlated with contrast dose ( P = .02 ) and a history of hypertension ( P = .02 ) 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-3 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 50 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 30 g of roasted flaxseed powder for 3 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 < 0.01 ) .


A lowering of systolic and diastolic blood pressure ( p < 0.05 ) was also recorded in the dyslipidemic subjects .


Concomitantly , a highly significant reduction ( p < 0.01 ) in total cholesterol , triglycerides , low density lipoprotein-cholesterol ( LDL-C ) , and very low density lipoprotein-cholesterol ( VLDL-C ) levels , with simultaneous elevation ( p < 0.01 ) 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 3 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 3 trial , eligible patients were 18 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 0-1 and unknown epidermal growth factor receptor ( EGFR ) mutation status who enrolled at 12 sites in Asia .


Patients randomly received ( 1:1 ) pemetrexed ( 500 mg/m ( 2 ) ) plus cisplatin ( 75mg/m ( 2 ) ) for six 21-day cycles , followed by gefitinib maintenance or gefitinib monotherapy ( 250 mg/day ) .


Patient tissue was retrospectively analysed for EGFR mutations .


This study is registered with ClinicalTrials.gov , NCT01017874 .


Between 23rd November 2009 and 27th April 2012 , 253 patients entered , and 236 patients were randomly assigned to and treated with PC therapy ( N = 114 ) and gefitinib monotherapy ( N = 118 ) .


Between-arm baseline characteristics were balanced .


PFS was not significantly different between treatment arms ( p = 0.217 ) .


The unadjusted hazard ratio ( HR ) was 0.85 ( 95 % confidence interval ( CI ) 0.63-1 .13 ) .


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


EGFR mutation status was determined for 74 tissue samples ; 50 ( 67.6 % ) had mutations .


In a pre-specified subgroup analysis , only the treatment-by-EGFR mutation interaction was significant ( p = 0.008 ) for PFS .


For the entire treatment period , a higher proportion of patients in the PC/gefitinib arm versus gefitinib experienced possibly drug-related grade 3-4 treatment-emergent adverse events ( 39 of 114 [ 34 % ] versus 19 of 118 [ 16 % ] ; p = 0.002 ) .


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 .


Eli Lilly and Company .


To determine whether EMD 1201081 , a TLR9 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 2 , open-label , randomized trial of EMD 1201081 0.32 mg/kg subcutaneously weekly plus cetuximab ( combination ) vs cetuximab monotherapy ( control ) in cetuximab-nave patients with R/M SCCHN who progressed on 1 cytotoxic regimen .


Crossover to combination was permitted after progression .


Objective response rate in both arms was 5.7 % ( 95 % CI 1.2-15 .7 % ) by independent assessment .


Disease control was 37.7 % for patients on combination ( 24.8-52 .1 % ) and 43.4 % on control ( 29.8-57 .7 % ) .


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


Median progression-free survival was 1.5 months ( 1.3-2 .6 ) for patients on combination , and 1.9 months ( 1.5-2 .9 ) on control .


The most frequent adverse events in the combination arm were rash ( 29.6 % ) , acneiform dermatitis ( 22.2 % ) , and injection site reactions ( 20.4 % ) .


Grade 3/4 dyspnea and hypokalemia were more frequent with cetuximab monotherapy ( 7.5 % and 5.7 % vs 1.9 % each , respectively ) , and grade 3/4 respiratory failure and disease progression were more frequent with combination ( 5.6 % each vs 1.9 % each ) .


EMD 1201081 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 50 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 48-50 years .


Recruitment to the study was done by telephone ; women were eligible if they had not had mammography in the past 2 years and did not have a personal or strong family history of breast cancer .


With a computer program , we randomly assigned 879 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 3 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 ACTRN12613001035718 .


Between January , 2014 , and July , 2014 , 440 women were allocated to the intervention group and 439 were assigned to the control group .


21 women in the intervention group and 20 controls were lost to follow-up ; a further ten women assigned to the intervention and 11 controls did not answer all questions on attitudes .


Therefore , 409 women in the intervention group and 408 controls were analysed for the primary outcome .


99 ( 24 % ) of 409 women in the intervention group made an informed choice compared with 63 ( 15 % ) of 408 in the control group ( difference 9 % , 95 % CI 3-14 ; p = 00017 ) .


Compared with controls , more women in the intervention group met the threshold for adequate overall knowledge ( 122/419 [ 29 % ] vs 71/419 [ 17 % ] ; difference 12 % , 95 % CI 6-18 ; p < 00001 ) , fewer women expressed positive attitudes towards screening ( 282/409 [ 69 % ] vs 340/408 [ 83 % ] ; 14 % , 9-20 ; p < 00001 ) , and fewer women intended to be screened ( 308/419 [ 74 % ] vs 363/419 [ 87 % ] ; 13 % , 8-19 ; p < 00001 ) .


When conceptual knowledge alone was considered , 203 ( 50 % ) of 409 women in the intervention group made an informed choice compared with 79 ( 19 % ) of 408 in the control group ( p < 00001 ) .


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 .


Australian National Health and Medical Research Council .


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


Women ( n = 5404 ) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples .


A subset ( n = 1044 ) was tested for HPV DNA ( SPF10/LiPA25 version 1 ) .


VE against 1-time detection of vulvar HPV16/18 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 = 536 ) .


Vulvar HPV16/18 VE ( 54.1 % ; 95 % confidence interval [ CI ] , 4.9 % -79.1 % ) was comparable to cervix ( 45.8 % ; 95 % CI , 6.4 % -69.4 % ) .


Vulvar and cervical HPV16 prevalence within the control arm was 3.0 % and 4.7 % , respectively .


Independent risk factors for vulvar HPV were similar to cervix and included : age ( adjusted odds ratio [ aOR ] 0.5 [ 95 % CI , .3 -.9 ] 28 vs 22-23 ] ) ; marital status ( aOR 2.3 [ 95 % CI , 1.5-3 .5 ] single vs married/living-as-married ) ; and number of sexual partners ( aOR 3.6 [ 95 % CI , 1.9-7 .0 ] 6 vs 1 ) .


In this intention-to-treat analysis , VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination .


Risk factors for HPV were similar by anatomic site .


NCT00128661 .


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 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions : 1:1:1 or 1:1:2 , ( 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 24h and 30 days were evaluated .


Between August 2012 and December 2013 , 680 patients were randomized .


The overall median time from admission to randomization was 26min .


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 3 years ( n = 406 ) .


Nearly 43 % reported CVD-medication nonadherence in the past month .


In simple linear regression , the following were associated with higher life chaos : medication nonadherence ( = 1.86 ; 95 % confidence interval [ CI ] , 0.96-2 .76 ) , female sex ( = 1.22 ; 95 % CI [ 0.22-2 .24 ] ) , minority race ( = 1.72 ; 95 % CI [ 0.78-2 .66 ] ) , having less than high school education ( = 2.05 ; 95 % CI [ 0.71-3 .39 ] ) , low health literacy ( = 2.06 ; 95 % CI [ 0.86-3 .26 ] ) , and inadequate financial status ( = 1.93 ; 95 % CI [ 0.87-3 .00 ] ) .


Being married ( = -2.09 , 95 % CI [ -3.03 to -1.15 ] ) 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 1-unit life chaos increase was associated with a 7 % increase ( odds ratio , 1.07 ; 95 % CI [ 1.02-1 .12 ] ) 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 .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT000901277 .


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 10 mg intravenous dose as a constant rate 30 min infusion or a 25mg sublingual dose of ketamine wafer in two treatment periods with a 7 day wash out .


Pharmacokinetic blood sampling and local tolerability and safety assessments were carried out during 24 h following both dosing occasions .


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


The median ( 90 % CI lower , upper limit ) absolute bioavailability of sublingual ketamine was 29 % ( 27 , 31 % ) .


The first quantifiable plasma ketamine concentration was observed within 5 min for all eight participants for both routes of administration and the median ( minmax ) time of the peak plasma concentration was 0.75 h ( 0.251.0 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-1018 ) that uses a Toll-like receptor 9 agonist demonstrated superior SPRs to 4 double doses of HBsAg-Eng in a large phase 3 trial of CKD patients .


A prespecified subgroup analysis of immunogenicity was conducted in CKD participants with type 2 diabetes in the phase 3 trial .


In 328 participants , the peak SPR in the HBsAg-1018 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-1018 group was statistically significantly higher than in the HBsAg-Eng group .


HBsAg-1018 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 2 techniques would further improve outcomes in preterm neonates .


This was a prospective randomized trial for singleton deliveries with estimated gestational ages between 22 and 31 6/7 weeks .


The control protocol required a 30-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 67 patients analyzed , 32 were randomized to the control arm and 35 were randomized to the test arm .


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


Mean hematocrit of the control arm was 47.75 % , and the mean hematocrit for the test arm was 47.71 % ( P = .98 ) .


These results were stratified by gestational age , revealing the infants less than 28 weeks had an average hematocrit of 41.2 % in the control arm and 44.7 % in the test arm ( P = .12 ) .


In the infants with gestational ages of 28 weeks or longer , the control arm had an average hematocrit of 52.9 % , which was higher than the test arm , which averaged 49.5 % ( P = .04 ) .


The control arm received an average of 1.53 blood transfusions , whereas the test arm received 0.97 ( P = .33 ) .


The control arm had 3 neonatal deaths , and the test arm had none ( P = .10 ) .


The average number of days until discharge was 71.2 for the control arm and 67.8 for the test arm ( P = .66 ) .


The average number of days on the ventilator was 4.86 for the control arm and 3.06 for the test arm ( P = .34 ) .


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 28 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 6,524 patients , 2,404 ( 36.8 % ) 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 = 0.384 ) .


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 = 0.329 ) .


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 ( 20 patients , control group : CG ) , and PRP + sessions of interactive videogame-aided exercises ( 20 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 2011 to December 2012 .


A total of 35,477 non-responders were invited to participate in an HPV self-sampling study ; 5347 women did opt out .


Finally , 30,130 women received a questionnaire and self-sampling device .


The analysis was based on 9484 returned questionnaires ( 31.5 % ) with a self-sample specimen , and 682 ( 2.3 % ) without .


Among women who returned both , the main reason for non-attendance to cervical screening was that they forgot to schedule an appointment ( 3068 ; 32.3 % ) .


The most important reason to use the self-sampling device was the opportunity to take a sample in their own time-setting ( 4763 ; 50.2 % ) .


A total of 30.9 % 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 100 diabetic patients with chronic stable angina were prospectively enrolled , then randomly assigned to undergo PCI with intracoronary Adenosine ; 100 g/stented vessel ( group-A , 50 patients ) or standard PCI ( group-B , 50 patients ) .


Cardiac troponin I ( cTnI ) and creatine kinase-MB ( CK-MB ) levels were measured before and 6 , 12 and 24 hours post-PCI .


Mean age of the study cohort was 578 years ( males = 63 % ) .


cTnI level was significantly lower in group-A ( 6 hours : 7.50.2 vs. 15.50.5 pg/mL , 12 hours : 13.70.7 vs. 25.50.6 pg/mL and 24 hours : 7.60.5 vs. 160.3 pg/mL , P < 0.001 ) .


After 3 months , the same group showed significantly higher left ventricle ejection fraction ( LVEF % ) , i.e. 64.55.7 vs. 56.55.3 ( P < 0.05 ) .


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 3 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 35 to 42 gestational weeks ' neonates .


They were randomized either to receive feeding supplementation with S. boulardii 125mg every 12 hours or placebo during phototherapy .


Serum bilirubin levels were measured at 0 , 24th , 48th , 72nd , and 96th hour of phototherapy .


A total of 119 infants ( 61 in the control group and 58 in the study group ) were enrolled .


The duration of phototherapy ( 2 [ 1-3 ] vs. 2 [ 1-3 ] , p : 0.22 ) was not different between groups .


The levels of bilirubin during phototherapy ( [ 24th hour ; 14.1 { 12.8-15 .7 } vs. 13.5 { 12.4-14 .9 } , p : 0.085 ] ; [ 48th hour ; 14.1 { 12-15 .3 } vs. 13.4 { 12.4-14 .5 } , p : 0.41 ] ; [ 72nd hour ; 13.9 { 12.2-15 .6 } vs. 13.5 { 12.5-14 .5 } , p : 0.41 ] ; [ 96th hour ; 14.7 { 11.4-15 .5 } vs. 13.4 { 10.7-14 .1 } , p : 0.24 ] ) or the duration of rebound phototherapy ( 1 [ 1-1 ] vs. 1.5 [ 1-2 ] , p : 0.40 ) 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 ) 3-dimensional ( 3D ) bifurcation angle ( BA ) parameters on 5-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 ; 3D 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 5-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 3D BA was available pre - and post-PCI .


Of 266 patients eligible for analysis , 185 underwent bifurcation PCI ( group B ) ; 1 stent was used in 75 patients ( group B1 ) , whereas 2 stents were used in 110 patients ( group B2 ) .


Stratification across pre-PCI diastolic distal BA tertiles ( < 82 , 82 to 106 , 107 ) failed to show any difference in MACCE rates either in the entire study population ( p = 0.99 ) or in group B patients ( p = 0.78 ) .


Group B patients with post-PCI systolic-diastolic range < 10 had significantly higher MACCE rates ( 50.8 % vs. 22.7 % , p < 0.001 ) ; repeat revascularization and safety endpoint rates were also higher ( 37.4 % vs. 15.5 % , p = 0.002 , and 25.4 % vs. 14.1 % , p = 0.055 , respectively ) .


Post-PCI systolic-diastolic range < 10 was an independent predictor of MACCE ( hazard ratio : 2.65 ; 95 % confidence interval : 1.55 to 4.52 ; p < 0.001 ) in group B patients .


A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-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 14-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 ( 32 1C , 11.5 h ) and indoor strength ( 23 1C , 9.3 h ) sessions and slept ( 12 nights ) and cycled indoors ( 4.3 h ) in either normal air ( NORM , n = 8 ) or normobaric hypoxia ( 14 1 h/day , FiO2 15.2-14 .3 % , corresponding to a simulated altitude of 2500-3000 m , hypoxic ( HYP ) , n = 9 ) .


They completed the Yo-Yo Intermittent Recovery level 2 ( Yo-YoIR2 ) in temperate conditions ( 23 1C , normal air ) precamp ( Pre ) and postcamp ( Post ) .


Plasma volume ( PV ) and haemoglobin mass ( Hb ( mass ) ) were measured at similar times and 4 weeks postcamp ( 4WPost ) .


Sweat sodium concentration ( ( Na ( + ) ) ( sweat ) ) was measured Pre and Post during a heat-response test ( 44C ) .


Both groups showed very large improvements in Yo-YoIR2 at Post ( +44 % ; 90 % CL 38 , 50 ) , with no between-group differences in the changes ( -1 % ; -9 , 9 ) .


Postcamp , large changes in PV ( +5.6 % ; -1.8 , 5.6 ) and ( Na ( + ) ) sweat ( -29 % ; -37 , -19 ) were observed in both groups , while Hb ( mass ) only moderately increased in HYP ( +2.6 % ; 0.5 , 4.5 ) .


At 4WPost , there was a likely slightly greater increase in Hb ( mass ) ( +4.6 % ; 0.0 , 9.3 ) and PV ( +6 % ; -5 , 18 , unclear ) in HYP than in NORM .


The combination of heat and hypoxic exposure during sleep/training might offer a promising ` conditioning cocktail ' in team sports .


Probably related to immune dysfunction , psoriasis vulgaris is a chronic , painful , disfiguring and disabling dermatological disease , carrying an increased risk of serious comorbidities .


Current conventional therapies can be costly , show risks of side effects and have limited efficacy , with relapse common on treatment cessation .


Chinese herbal medicine is effective in treating psoriasis vulgaris .


However , any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined .


This is a pilot randomized , placebo controlled , double-blinded trial .


The pilot is primarily to determine the feasibility of undertaking a full size randomized trial .


Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index ( PASI ) scores 7 and 12 will be included .


Participants will be randomized ( in a 1:1 ratio ) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005 % or oral YXBCM01 placebo plus topical calcipotriol 0.005 % treatment for 12 weeks , with a 12-week follow-up phase .


The Chinese herbal medicine or placebo will be administered orally as dissolvable granules .


The primary outcome measure will be PASI change ( % ) from baseline to the end of treatment phase .


Secondary outcomes will include safety , key psoriasis-related cytokine changes ( for example , IL12 , IL17 and IL 23 ) during the entire trial and symptom relapse rates at the end of the follow-up phase .


The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris .


The ingredients of YXBCM01 were selected based on literature , the expert opinion on herbal medicine and pre-clinical evidence , for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties .


Australian New Zealand Clinical Trials Registry ACTRN12614000493640 .


Haemodialysis patients suffer from accelerated vascular calcification .


The vitamin K-dependent matrix Gla protein ( MGP ) is one of the most powerful inhibitors of vascular calcification .


Haemodialysis patients have high levels of the inactive form of MGP ( desphosphorylated-uncarboxylated-MGP , dp-uc-MGP ) and may benefit from pharmacological doses of vitamin K2 ( menaquinone ) to improve the calcification inhibitory activity of MGP .


To determine the optimal dose of menaquinone-7 ( MK-7 ) for MGP activation , 200 chronic haemodialysis patients were recruited to randomly receive 360 , 720 or 1080 g of MK-7 thrice weekly for 8 weeks .


Dp-uc-MGP was measured at baseline and after 8 weeks .


Dietary intake of vitamin K1 ( phylloquinone ) and menaquinone was estimated based on a detailed questionnaire .


At baseline , dp-uc-MGP was not associated with phylloquinone intake ( P = 0.92 ) , but correlated inversely with menaquinone intake ( P = 0.023 ) .


MK-7 supplementation dose dependently reduced dp-uc-MGP .


The levels decreased by 17 , 33 and 46 % in the respective groups .


Drop-outs were mainly due to gastrointestinal side-effects related to the unpleasant smell of the tablets .


Chronic haemodialysis patients have high levels of inactive MGP , possibly related to a low dietary vitamin K intake .


Pharmacological doses of MK-7 dose-dependently reduce dp-uc-MGP .


Menaquinone supplementation may be a novel approach to prevent vascular calcifications in chronic haemodialysis patients .


To evaluate short term quality of life of patients with chronic rhinosinusitis by using Chinese version of the sinonasal outcome test-22 ( SNOT-22 ) and to formulate an ideal therapy system for patients with chronic rhinosinusitis .


Using prospective randomized controlled design , we chose the SNOT-22 to evaluate and compare 78 CRS patients ' quality of life ( QOL ) before surgery , at 1-month ,3 - month , 6-month and 9-month after functional endoscopic sinus surgery ( FESS ) .


At the same time , we randomly chose 100 healthy controls to compare their QOL with those of CRS patients after FESS .


We found that except for 5 items ( cough , ear expanding , otalgia , facail pain and weary ) , the grade of 17 other items of CRS patients were significantly higher than those of the healthy controls ( P < 0.05 ) .


There was no significant difference in 7 items ( olfactory sensation , hypogeusis , backflow of nasal discharge , difficult to fall asleep , bad sleep , bad work efficiency , depression , embarrassment ) at 3 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) .


There was no significant difference in 9 items ( blow noses , sneeze , rhinorrhea , nasal discharge thickness , dizziness , night wake , tired of wake , attention deficit , sense of loss ) at 6 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) .


There was no significant difference in nasal obstruction at 6 months after FESS between chronic rhinosinusitis patients and healthy controls ( P > 0.05 ) , at this time the totle grade was normal ( P > 0.05 ) .


The recovery period of QOL in patients was about 9 months ( P > 0.05 ) .


The 5 great items were nasal obstruction , olfactory sensation , hypogeusis , nasal discharge , nasal discharge thickness and blow noses .


There was no difference in items except for bad sleep replacing nasal discharge thickness between 1-month and 9-month after surgery .


The Chinese vesion of SNOT-22 could evaluate QOL of CRS patients in this area .


The recovery of QOL of CRS patients needs about 6 months after FESS , but problems of olfactory sensation , hypogeusis , nasal discharge and difficult to sleeep still needs to be resolved .


Altered mental status ( AMS ) is a common presentation in the emergency department ( ED ) .


A previous study revealed 78 % electroencephalogram ( EEG ) abnormalities , including nonconvulsive seizure ( NCS ; 5 % ) , in ED patients with AMS .


The objective of this study was to assess the impact of EEG on clinical management and outcomes of ED patients with AMS .


This was a randomized controlled trial at two urban teaching hospitals .


Adult patients ( 18 years old ) with AMS were included .


Excluded patients had immediately correctable AMS ( e.g. , hypoglycemia ) or were admitted before enrollment .


Patients were randomized to routine care ( control ) or routine care plus EEG ( intervention ) .


Research assistants used a scalp electrode set with a miniature , wireless EEG device ( microEEG ) to record standard 30-minute EEGs at presentation , and results were reported to the ED attending physician by an off-site epileptologist within 30 minutes .


Primary outcomes included changes in ED management ( differential diagnosis , diagnostic work-up , and treatment plan from enrollment to disposition ) as determined by surveying the treating physicians .


Secondary outcomes were length of ED and hospital stay , intensive care unit ( ICU ) requirement , and in-hospital mortality .


A total of 149 patients were enrolled ( 76 control and 73 intervention ) .


Patients in the two groups were comparable at baseline .


EEG in the intervention group revealed abnormal findings in 93 % ( 95 % confidence interval [ CI ] = 85 % to 97 % ) , including NCS in 5 % ( 95 % CI = 2 % to 13 % ) .


Using microEEG was associated with change in diagnostic work-up in 49 % ( 95 % CI = 38 % to 60 % ) of cases and therapeutic plan in 42 % ( 95 % CI = 31 % to 53 % ) of cases immediately after the release of EEG results .


Changes in probabilities of differential diagnoses and the secondary outcomes were not statistically significant between the groups .


An EEG can be obtained in the ED with minimal resources and can affect clinical management of AMS patients .


To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Triumph with SmartGuide with Oral-B CrossAction brush head ) versus a sonic toothbrush ( Sonicare DiamondClean ) for plaque and gingivitis reduction over a six-week period .


This was a single-center , randomized , examiner-blind , two-treatment , parallel group study involving 65 subjects per group .


Subjects presenting with mild-to-moderate gingivitis at Baseline were randomly assigned to either the oscillating-rotating brush or the sonic brush .


They were instructed to use their assigned toothbrush and a standard fluoride dentifrice for two minutes twice daily at home for six weeks .


Gingivitis and plaque were assessed at Baseline and Week 6 using the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and Rustogi Modified Navy Plaque Index ( RMNPI ) .


Data were analyzed using an Analysis of Covariance ( ANCOVA ) , with baseline as the covariate .


Subjects also completed a consumer perception questionnaire to evaluate their brushing experience .


One-hundred and thirty subjects were enrolled in the study and randomized to treatment .


Sixty-four subjects per group completed the trial .


Both brushes produced statistically significant reductions in gingivitis and plaque measures at Week 6 relative to Baseline ( p < 0.001 for all ) .


The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in all gingivitis and plaque measures compared to the sonic toothbrush .


The benefits for the oscillating-rotating brush over the sonic brush were 32.6 % for gingivitis , 35.4 % for gingival bleeding , 32 % for number of bleeding sites , 22 % for whole mouth plaque , 24.2 % for gingival margin plaque , and 33.3 % for approximal plaque ( p < or = 0.001 for all measures except gingival margin plaque , where p = 0.018 ) .


Analysis of the consumer perception questionnaire results showed subjects using the oscillating-rotating brush rated it higher for overall use experience and key attributes related to cleaning , gentleness , and brush head shape/size versus subjects in the sonic brush group .


There were no adverse events reported or observed for either brush .


This six-week randomized , examiner-blind , comparative clinical study showed the oscillating-rotating toothbrush , with a novel brush head incorporating angled CrissCross bristles , was significantly better than an advanced sonic power toothbrush at reducing gingival inflammation and bleeding , as well as reducing whole mouth plaque , plaque along the gumline , and in the approximal regions .


To compare the differences in the efficacy on distant version of naked eye in the patients of juvenile myopia between rotating manipulation and lifting-thrusting manipulation of acupuncture .


One hundred and twenty cases ( 240 eyes ) were randomized into a rotating manipulation group and a lifting-thrusting manipulation group , 60 cases ( 120 eyes ) in each group .


Additionally , a corrective lenses group , 60 cases ( 120 eyes ) , was set up as the control .


In both manipulation groups , Cuanzhu ( BL 2 ) , Yuyao ( EX-HN 4 ) , Sizhukong ( TE 23 ) , Taiyang ( EX-HN 5 ) , Fengchi ( GB 20 ) , Zusanli ( ST 36 ) , Guangming ( GB 37 ) and Sanyinjiao ( SP 6 ) were punctured , but stimulated with rotating manipulation and lifting-thrusting manipulation respectively three times per week , 10 times as a treatment session and totally one session was required .


In the corrective lenses group , the glasses were applied at daytime .


The clinical efficacy and the changes in distant vision of naked eye before and after treatment were compared among the three groups .


The total effective rate was 87.5 % ( 105/120 ) in the rotating manipulation group , which was better than 69.2 % ( 83/120 ) in the lifting-thrusting manipulation group ( P < 0.05 ) .


The distant vision of naked eye was improved apparently in the rotating manipulation group and the lifting-thrusting manipulation group after treatment ( both P < 0.05 ) .


But it was not improved in the corrective lenses group ( P > 0.05 ) .


The distant vision of naked eye was improved more apparently after treatment in the rotating manipulation group as compared with that in the lifting-thrusting manipulation group ( 0.75 + / - 0.23 vs 0.68 + / - 0.24 , P < 0.05 ) .


For 96 cases ( 192 eyes ) with acupuncture treatment , in 3-month follow-up , 87.0 % ( 167/192 ) of the cases maintained the stable vision as the original level and 13.0 % ( 25/192 ) of them were reduced in the vision In the acupuncture groups , it was found that the improvement of distant vision of naked eye was more obvious after treatment with younger age , better basic vision and shorter duration of sickness ( all P < 0.05 ) .


Acupuncture achieves the positive and sustainable clinical effect on juvenile myopia , and the results of rotating manipulation are superior to that of lifting-thrusting manipulation .


Age , basic vision and duration of sickness impact the clinical efficacy .


To evaluate the efficacy of pomegranate juice supplementation on matrix metalloproteinases2 and 9 serum levels and improving antioxidant function in young healthy males during exhaustive exercise .


The study was conducted at Ardabil University of Medical Sciences , Iran , in 2010-11 and comprised 28 healthy subjects in 18-24 age bracket .


They were randomly divided into control and supplemented groups .


One cup of pomegranate juice and one cup of tap water were given to supplemented and control groups daily for two weeks respectively .


Fasting blood samples were taken at baseline and at the end of two weeks of intervention .


The subjects were given one exhaustive exercise and then fasting blood samples were taken for testing blood glutathione peroxidase and superoxide dismutase and serum levels of high sensitivity C-reactive protein , zinc , ceruloplasmin , matrix metalloproteinases 2 and 9 , malondialdehyde and total antioxidant capacity .


Data was analysed using descriptive statistical tests , paired and independent sample t-test .


The blood levels of glutathione peroxidase and superoxide dismutase and serum levels of total antioxidant capacity after exhaustive exercise in the supplemented group were significantly increased ( p < 0.05 ) , while the content of matrix metalloproteinases 2 and 9 , ceruloplasmin and malondialdehyde showed a significant decrease in comparison to the control group ( p < 0.05 ) .


Besides , there were no significant changes in other biochemical factors .


Regular intake of pomegranate juice significantly modulates matrix metalloproteinases 2 and 9and serum levels of some inflammatory factors and thus protects against exhaustive exercise-induced oxidative injury in young healthy males .


Chronic postoperative pain is probably the most significant complication of tension-free inguinal hernia repair as its presence can considerably affect the life quality of the patient .


Different mesh materials and different surgical techniques for mesh fixation have been applied to reduce chronic postoperative pain , with controversial , nevertheless , results .


The aim of this prospective randomized study was to evaluate the effect of a relatively new mesh with self-fixating properties , used to repair inguinal hernia with the Lichtenstein technique , on early and chronic postoperative pain .


Between June 2009 and June 2010 , 50 patients with primary unilateral inguinal hernia were treated using the Lichtenstein technique .


Patients were randomly assigned to receive either a polypropylene mesh , fixed with polypropylene sutures ( n = 25 ; group A ) , or a self-fixating polypropylene mesh with resorbable polylactic acid microgrips ( n = 25 ; group B ) .


Demographic data were recorded .


Early and chronic postoperative pain was evaluated using the visual analog scale ( VAS ) .


Duration of surgery , complications , length of hospitalization and recurrence were also recorded .


No statistical difference was found between the two groups in association to demographic data .


Operating time was 53.4 12.5 and 44.4 7.2 min in groups A and B , respectively , and the difference was statistically significant ( p < 0.001 ) .


No difference was observed between the groups regarding the postoperative complications .


The VAS of early postoperative pain was 1.7 1.9 in group A and 1.3 1.6 in group B , with the difference being not statistically significant ( p = 0.21 ) .


Concerning chronic pain , no remarkable statistically significant difference was observed between the two groups at 3-month , 1 - and 2-year follow-up period .


At the end of the study , no recurrence was reported in either group .


Self-fixating mesh can be safely and effectively used in inguinal hernia repair with the additional advantage of reducing the operative time compared to the classic Lichtenstein technique .


However , its use is not accompanied by reduced rates in early or chronic postoperative pain .


It has been shown that nasal saline irrigation ( NSI ) alone can be effective in children with infectious and/or allergic respiratory problems , but no study has assessed the awareness or clinical use of NSI among practising pediatricians .


The main aim of this study was to evaluate the use of NSI in pre-school children by primary care pediatricians working in northern Italy .


Nine hundred randomly selected National Health Service primary care pediatricians with an e-mail address were sent an e-mail asking whether they were willing to respond to a questionnaire regarding the use of NSI .


The 870 who answered positively were sent an anonymous questionnaire by post and e-mail that had 17 multiple-choice items .


Completed questionnaires were received from 860 of the 870 primary care pediatricians ( 98.8 % ) .


NSI was used by almost all the respondents ( 99.3 % ) , although with significant differences in frequency .


It was considered both a prophylactic and a therapeutic measure by most of the respondents ( 60.3 % ) , who prescribed it every day for healthy children and more frequently when they were ill .


Most of the primary care pediatricians ( 87 % ) indicated an isotonic solution as the preferred solution , and the most frequently recommended administration devices were a nasal spray ( 67.7 % ) and bulb syringe ( 20.6 % ) .


Most of the pediatricians ( 75.6 % ) convinced parents to use NSI by explaining it could have various beneficial effects , and two-thirds ( 527/854 ; 61.7 % ) thought that most of the parents agreed about the importance of NSI .


Analysis of possible associations between NSI prescribing behaviour and the demographic data revealed an associations with age and gender , with pediatricians aged < 50 years prescribing NSI more frequently than their older counterparts ( p < 0.01 ) , and females prescribing NSI more frequently than males ( p < 0.01 ) .


In Northern Italy , most primary care pediatricians prescribe NSI for both the prophylaxis and therapy of upper respiratory tract problems in pre-school children .


However , many aspects of the procedure are not clarified , and this reduces parental compliance .


Given the medical and economic advantages of NSI , this situation should be changed as soon as possible .


To determine whether the use and adjustment of antidepressant pharmacotherapy accounted for the beneficial effects of collaborative care treatment on the improvement of mood symptoms and health-related quality of life ( HRQoL ) after coronary artery bypass graft ( CABG ) surgery .


In a post-hoc analysis of data from the Bypassing the Blues ( BtB ) trial we tested the impact of antidepressant medication on changes in depression and HRQoL from the early postoperative period to 8-month follow-up .


Two hundred fifty-nine depressed post-CABG patients scoring 10 on the Patient Health Questionnaire-9 were classified in four groups according to whether or not they received antidepressants at baseline and 8-months following randomization .


Patients using antidepressant pharmacotherapy at baseline and follow-up tended to be younger and female ( p0 .01 ) , but were similar in various clinical characteristics .


Just 24 % ( 63/259 ) of patients were on an antidepressant at baseline which increased to 36 % at follow-up ( 94/259 ) .


Compared to other groups , patients on antidepressants at both baseline and follow-up assessment showed the smallest improvement in mood symptoms and HRQoL .


While multivariate analyses confirmed that randomization to collaborative care was associated with greater improvement in mood symptoms ( odds ratio [ OR ] = 3.1 ; 95 % - confidence interval [ CI ] = 1.8-5 .4 , p < 0.0001 ) and mental HRQoL ( OR = 3.6 , CI = 1.4-9 .3 , p = 0.01 ) , use of antidepressant medication had no differential impact on either measure ( p = 0.06 and p = 0.92 , respectively ) .


The beneficial effects of collaborative care for post-CABG depression were not generated by adjustments in antidepressant medication .


Clinicaltrials.gov Identifier : NCT00091962 .


( http://clinicaltrials.gov/ct2/show/NCT00091962?term=rollman+cabg&rank=1 ) .


Many adolescents with obsessive-compulsive disorder ( OCD ) do not have access to evidence-based treatment .


A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy ( TCBT ) for adolescents with OCD compared to standard clinic-based , face-to-face CBT .


Seventy-two adolescents , aged 11 through 18 years with primary OCD , and their parents were randomized to receive specialist TCBT or CBT .


The intervention provided differed only in the method of treatment delivery .


All participants received up to 14 sessions of CBT , incorporating exposure with response prevention ( E/RP ) , provided by experienced therapists .


The primary outcome measure was the Children 's Yale-Brown Obsessive-Compulsive Scale ( CY-BOCS ) .


Blind assessor ratings were obtained at midtreatment , posttreatment , 3-month , 6-month , and 12-month follow-up .


Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment , 3-month , and 6-month follow-up .


At 12-month follow-up , there were no significant between-group differences on the CY-BOCS , but the confidence intervals exceeded the non-inferiority threshold .


All secondary measures confirmed non-inferiority at all assessment points .


Improvements made during treatment were maintained through to 12-month follow-up .


Participants in each condition reported high levels of satisfaction with the intervention received .


TCBT is an effective treatment and is not inferior to standard clinic-based CBT , at least in themidterm .


This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD .


Clinical trial registration information-Evaluation of telephone-administered cognitive-behaviour therapy ( CBT ) for young people with obsessive-compulsive disorder ( OCD ) ; http://www.controlled-trials.com; ISRCTN27070832 .


Many cannabinoid medications are approved in North America or in phase III trials , such as dronabinol , nabilone , or nabiximols .


Little is known about their subjective psychoactive effects when used for pain management .


We hypothesized that when used for pain , dronabinol has psychoactive effects in a dose-response relationship , whose peak effects are comparable with smoking marijuana .


This was a randomized controlled trial of single dose placebo , 10 or 20 mg dronabinol in 30 chronic noncancer pain patients taking opioids and not using marijuana .


Participants completed the Addiction Research Center Inventory ( ARCI ) hourly for 8 hours during 3 monitored sessions .


Comparison sample was the ARCI ratings in participants with no pain ( N = 20 ) , monitored every 30 minutes after smoking a 1.99 % THC ( low ) and a 3.51 % ( high strength ) marijuana cigarette .


The 10 and 20 mg dronabinol doses had significantly elevated scores over time on 4/5 subscales versus placebo ( P < 0.05 ) .


Average daily morphine use , total pain relief ( TOTPAR ) , age , sex , and baseline pain level were not significant covariates .


ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes ( P = 0.80 , 10 mg = low strength , 20 mg = high strength ) .


In pain patients , oral dronabinol has similar psychoactive effects to smoking marijuana .


This risk must be considered in any decision to prescribe cannabinoid medications for pain .


Self-harm is a major risk factor for completed suicide .


To determine the efficacy of a brief psychological intervention - culturally adapted manual-assisted problem-solving training ( C-MAP ) - delivered following an episode of self-harm compared with treatment as usual ( TAU ) .


The study was a randomised controlled assessor-masked clinical trial ( trial registration : ClinicalTrials.gov NCT01308151 ) .


All patients admitted after an episode of self-harm during the previous 7 days to the participating medical units of three university hospitals in Karachi , Pakistan , were included in the study .


A total of 250 patients were screened and 221 were randomly allocated to C-MAP plus treatment as usual ( TAU ) or to TAU alone .


All patients were assessed at baseline , at 3 months ( end of intervention ) and at 6 months after baseline .


The primary outcome measure was reduction in suicidal ideation at 3 months .


The secondary outcome measures included hopelessness , depression , coping resources and healthcare utilisation .


A total of 108 patients were randomised to the C-MAP group and 113 to the TAU group .


Patients in the C-MAP group showed statistically significant improvement on the Beck Scale for Suicide Ideation and Beck Hopelessness Inventory , which was sustained at 3 months after the completion of C-MAP .


There was also a significant reduction in symptoms of depression compared with patients receiving TAU .


The positive outcomes of this brief psychological intervention in patients attempting self-harm are promising and suggest that C-MAP may have a role in suicide prevention .


Bladder pain syndrome/interstitial cystitis ( BPS/IC ) is a chronic disease that highly degrades the quality of life for patients .


In the present study , Internet intervention was used to care for bladder pain syndrome/interstitial cystitis patients to alleviate their pain and bothering symptoms .


Healthcare education was carried out through the Internet by asking the patients , who were randomly divided into study ( 40 patients ) and control ( 40 patients ) groups , to check possible sensitive foods , habits , and behaviors weekly to remind and consolidate important rules for promoting quality of life .


The symptom flares consultation through short message service with the Internet used to elevate healthcare efficiency was undertaken .


Questionnaires , including Short Form 36 health survey , O'Leary-Sant symptom and problem indices , as well as visual analog scales pain and urgency scales , were used to evaluate quality of life and disease severity improvements before and after information and communication technology intervention .


The outcome was evaluated at week 8 .


The quality of life of both the control and study groups was significantly improved .


The quality of life and visual analog scales for the patients in the study group with information and communication technology intervention showed a much greater improvement compared with the patients in the control group ( P < 0.05 ) .


The E-health system was shown to be effective in improving quality of life of bladder pain syndrome/interstitial cystitis patients through intervention of Internet healthcare education and short message service for the consolidation of healthy behavior and lifestyle in the 8-week follow up .


Bleeding limits anticoagulant treatment in patients with acute coronary syndromes ( ACS ) .


We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS .


This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo .


In a post-hoc analysis , we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate .


At baseline , of 7,364 patients , 16.3 % ( n = 1,202 ) were on aspirin alone , and 79.0 % ( n = 5,814 ) were on aspirin plus clopidogrel .


A total of 19.2 % ( n = 1,415 ) switched antiplatelet therapy during follow-up .


No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death , myocardial infarction , and ischemic stroke in patients taking aspirin ( 12.21 per 100 patient-years vs. 13.21 per 100 patient-years ; adjusted hazard ratio [ HR ] : 0.91 ; 95 % confidence interval [ CI ] : 0.62 to 1.32 ) or aspirin plus clopidogrel ( 13.22 vs. 14.24 ; adjusted HR : 0.95 ; 95 % CI : 0.78 to 1.14 ; p ( interaction ) = 0.84 ) .


Compared with placebo , apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin ( 1.48 vs. 0.25 ; adjusted HR : 6.62 ; 95 % CI : 0.75 to 51.73 ) and in patients taking aspirin plus clopidogrel ( 2.58 vs. 1.02 ; adjusted HR : 2.44 ; 95 % CI : 1.34 to 4.45 ; p ( interaction ) = 0.41 ) .


Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention .


Post-ACS treatment with apixaban versus placebo showed no efficacy , but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel .


( Apixaban for Prevention of Acute Ischemic Events 2 [ APPRAISE-2 ] ; NCT00831441 ) .


Cold water immersion ( CWI ) may be beneficial for acute recovery from exercise , but it may impair long-term performance by attenuating the stimuli responsible for adaptation to training .


We compared effects of CWI and passive rest on cycling performance during a simulated cycling grand tour .


Thirty-four male endurance-trained competitive cyclists were randomized to CWI for four times per week for 15 min at 15C or control ( passive recovery ) groups for 7 d of baseline training , 21 d of intensified training , and an 11-d taper .


Criteria for completion of training and testing were satisfied by 10 cyclists in the CWI group ( maximal aerobic power , 5.13 0.21 Wkg ; mean SD ) and 11 in the control group ( 5.01 0.41 Wkg ) .


Each week , cyclists completed a high-intensity interval cycling test and two 4-min bouts separated by 30 min .


CWI was performed four times per week for 15 min at 15C .


Between baseline and taper , cyclists in the CWI group had an unclear change in overall 4-min power relative to control ( 2.7 % 5.7 % ) , although mean power in the second effort relative to the first was likely higher for the CWI group relative to control ( 3.0 % 3.8 % ) .


The change in 1-s maximum mean sprint power in the CWI group was likely beneficial compared with control ( 4.4 % 4.2 % ) .


Differences between groups for the 10-min time trial were unclear ( -0.4 % 4.3 % ) .


Although some effects of CWI on performance were unclear , data from this study do not support recent speculation that CWI is detrimental to performance after increased training load in competitive cyclists .


While self-report methods to collect exposure information have large practical advantages in many research contexts , little research has specifically investigated the reliability and validity of motorcyclists ' self-reported exposure .


The present study aimed to examine the reliability and validity of different self-report exposure measures and to provide recommendations on best practice self-report riding exposure questions .


The reliability and validity of different self-report exposure measures were examined amongst novice motorcyclists through t-tests , Bland Altman plots , coefficients of variation , and correlations .


The most valid and reliable data was provided when riding exposure was asked for the current average week rather than earlier and longer periods , and in units of time rather than distance or number of trips .


The greater reliability of riding exposure found amongst commuting and rural riders compared to recreational and metropolitan riders respectively and at the second interview compared to the first suggests that factors such as riding purposes , geographical locations , and riding experience can contribute to measurement error .


If self-reported odometer readings are used , questions on whether the respondents share their own bike or ride more than one bike , and a built-in process to ensure respondents report the exact odometer reading on their bike are recommended .


It is recommended that self-report riding exposure questions ask about the hours of riding for the current average week , and data on riding purposes , locations , and experience are also collected .


To determine whether gene expression profiles identified in peripheral whole blood samples could be used to determine therapeutic outcome in a cohort of children with newly diagnosed polyarticular juvenile idiopathic arthritis ( JIA ) .


Whole blood samples from the Trial of Early Aggressive Therapy ( TREAT ) in JIA patients were analyzed on Illumina microarrays , and differential gene expression was compared to expression in healthy controls .


Microarray results were validated by real-time quantitative polymerase chain reaction in an independent cohort of samples .


Pathway analysis software was used to characterize gene expression profiles .


Support vector machines were used to develop predictive models for different patient classes .


Differential gene expression profiles for rheumatoid factor ( RF ) - positive and RF-negative patients were remarkably similar .


Pathway analysis revealed a broad range of affected pathways , consistent with current mechanistic theories .


Modeling showed that the prognosis at 6 months was strongly linked to gene expression at presentation , irrespective of treatment .


Gene expression is linked to therapeutic outcome , and gene expression in the peripheral blood may be a suitable target for a prognostic test .


To examine counterregulatory glucose kinetics and test the hypothesis that - adrenergic blockade impairs these in patients with type 2 diabetes mellitus ( T2DM ) and advanced - failure .


Nine insulin-requiring T2DM subjects and six matched nondiabetic control subjects were studied .


- Cell function was assessed by the C-peptide response to arginine stimulation .


Counterregulatory hormonal responses and glucose kinetics were assessed by hyperinsulinemic euglycemic-hypoglycemic clamps with [ 3 - ( 3 ) H ] glucose infusion .


T2DM subjects underwent two clamp experiments in a randomized crossover fashion : once with infusion of the - adrenergic antagonist propranolol and once with infusion of normal saline .


Compared with the control subjects , T2DM subjects had threefold reduced C-peptide responses to arginine stimulation .


During the hypoglycemic clamp , glucagon responses were markedly diminished ( 16.0 4.2 vs. 48.6 6.0 ng/L , P < 0.05 ) , but other hormonal responses and the decrement in the required exogenous glucose infusion rate ( GIR ) from the euglycemic clamp were normal ( -10.4 1.1 vs. -7.8 1.9 mol kg ( -1 ) min ( -1 ) in control subjects ) ; however , endogenous glucose production ( EGP ) did not increase ( -0.8 1.0 vs. 2.2 0.7 mol kg ( -1 ) min ( -1 ) in control subjects , P < 0.05 ) , whereas systemic glucose disposal decreased normally .


- Adrenergic blockade in the T2DM subjects increased GIR 20 % during the euglycemic clamp ( P < 0.01 ) , but neither increased GIR during the hypoglycemic clamp or decreased its decrement from the euglycemic clamp to the hypoglycemic clamp .


Overall glucose counterregulation is preserved in advanced T2DM , but the contribution of EGP is diminished .


- Adrenergic blockade may increase insulin sensitivity at normoglycemia but does not impair glucose counterregulation in T2DM patients , even those with advanced - cell failure .


Medical simulation training requires effective and efficient training strategies .


Dyad practice may be a training strategy worth pursuing because it has been proven effective and efficient in motor skills learning .


In dyad practice two participants collaborate in learning a task they will eventually perform individually .


In order to explore the effects of dyad practice in a medical simulation setting , this study examined the effectiveness and efficiency of dyad practice compared with individual practice in the learning of bronchoscopy through simulation-based training .


A total of 36 students of medicine were randomly assigned to either individual practice or dyad practice .


The training setting included video-based instruction , 10 bronchoscopy simulator cases and instructor feedback .


Participants in the dyad practice group alternated between physical and observational practice and hence physically undertook only half of the training cases undertaken by participants who practised individually .


Pre - , post - and delayed ( 3weeks ) retention tests were used to assess skills according to previously validated simulator measures .


Data were analysed using repeated-measures analysis of variance ( anova ) on each dependent measure .


A significant main effect of test was found for all measures ( F2 ,67 > 23.32 , p < 0.001 ) , indicating improvement in performance from pre-tests to post-tests and retention tests .


No interaction was found between test and group ( F2 ,67 < 0.26 , p > 0.49 ) , indicating parallel learning curves .


Most importantly , no main effect of group was found for any of the measures , indicating no difference between learning curves ( F1 ,34 = 2.08 , p < 0.16 ) .


Individual practice and dyad practice did not differ in their effectiveness for the acquisition of bronchoscopy skills through supervised simulation training .


However , dyad practice proved more efficient than individual practice because two participants practising in dyads learned as much as one participant practising individually but required the same instructor resources and training time as the single learner .


Dolutegravir has been shown to be non-inferior to an integrase inhibitor and superior to a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) .


In FLAMINGO , we compared dolutegravir with darunavir plus ritonavir in individuals naive for antiretroviral therapy .


In this multicentre , open-label , phase 3b , non-inferiority study , HIV-1-infected antiretroviral therapy-naive adults with HIV-1 RNA concentration of 1000 copies per mL or more and no resistance at screening were randomly assigned ( 1:1 ) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus ritonavir 100 mg once daily , with investigator-selected tenofovir-emtricitabine or abacavir-lamivudine .


Randomisation was stratified by screening HIV-1 RNA ( 100,000 or > 100,000 copies per mL ) and nucleoside reverse transcriptase inhibitor ( NRTI ) selection .


The primary endpoint was the proportion of patients with HIV-1 RNA concentration lower than 50 copies per mL ( Food and Drug Administration [ FDA ] snapshot algorithm ) at week 48 with a 12 % non-inferiority margin .


This trial is registered with ClinicalTrials.gov , NCT01449929 .


Recruitment began on Oct 31 , 2011 , and was completed on May 24 , 2012 , in 64 research centres in nine countries worldwide .


Of 595 patients screened , 484 patients were included in the analysis ( 242 in each group ) .


At week 48 , 217 ( 90 % ) patients receiving dolutegravir and 200 ( 83 % ) patients receiving darunavir plus ritonavir had HIV-1 RNA of less than 50 copies per mL ( adjusted difference 71 % , 95 % CI 09-132 ) , non-inferiority and on pre-specified secondary analysis dolutegravir was superior ( p = 0025 ) .


Confirmed virological failure occurred in two ( < 1 % ) patients in each group ; we recorded no treatment-emergent resistance in either group .


Discontinuation due to adverse events or stopping criteria was less frequent for dolutegravir ( four [ 2 % ] patients ) than for darunavir plus ritonavir ( ten [ 4 % ] patients ) and contributed to the difference in response rates .


The most commonly reported ( 10 % ) adverse events were diarrhoea ( dolutegravir 41 [ 17 % ] patients vs darunavir plus ritonavir 70 [ 29 % ] patients ) , nausea ( 39 [ 16 % ] vs 43 [ 18 % ] ) , and headache ( 37 [ 15 % ] vs 24 [ 10 % ] ) .


Patients receiving dolutegravir had significantly fewer low-density lipoprotein values of grade 2 or higher ( 11 [ 2 % ] vs 36 [ 7 % ] ; p = 00001 ) .


Once-daily dolutegravir was superior to once-daily darunavir plus ritonavir .


Once-daily dolutegravir in combination with fixed-dose NRTIs represents an effective new treatment option for HIV-1-infected , treatment-naive patients .


ViiV Healthcare and Shionogi & Co. .


Nerve-preserving surgery has been provided for patients with rectal cancer ; however , sexual dysfunction remains a common complication of rectal cancer surgery .


This study explored the efficacy of udenafil to treat erectile dysfunction in male patients who underwent total mesorectal excision ( TME ) for rectal cancer .


We conducted a randomized , double-blind , placebo-controlled clinical trial involving 80 male patients who had decreased International Index of Erectile Function-5 ( IIEF-5 ) scores after TME for rectal cancer .


Patients received placebo ( 50 mg ) or udenafil ( 50 mg ) for 12 weeks .


The primary outcome variable was the change in IIEF-5 scores .


The secondary outcome variables were Sexual Encounter Profile ( SEP ) questions 2 ( Q2 ) and 3 ( Q3 ) , and the Global Assessment Question ( GAQ ) .


Baseline IIEF-5 scores , SEP Q2 and Q3 responses , and spontaneous erection rates were consistent in both groups .


At the end of treatment , the change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group ( mean IIEF-5 score , 4.8 4.0 vs 2.0 1.7 ; P < .05 ) .


Responses to SEP Q2 , SEP Q3 , and GAQ were significantly higher in the udenafil group than they were in the placebo group ( SEP Q2 , P = .025 ; SEP Q3 , P = .044 ; GAQ , P < .001 ) .


Treatment-related adverse events ( n = 4 ) were all mild in severity .