An individual patient database of stage III NSCLC patients treated with radical intent concurrent chemoradiation therapy was created ( 13 institutions , n = 1274 patients ) .


Patients were divided into 2 groups based on tumor Biological Effective Dose at 10 Gy ( BED 10 ) : those receiving standard dose ( SD ; n = 552 ) , consisting of 72Gy BED 10 76.8 Gy ( eg 60-64 Gy/30 -32 fractions [ fr ] ) , and those receiving intermediate dose ( ID ; n = 497 ) , consisting of 76.8 Gy < BED 10 < 100.8 Gy ( eg > 64 Gy/32 fr and < 74 Gy/37 fr ) , with lower-dose patients ( n = 225 ) excluded from consideration .


Patients were then matched using propensity scores , leading to 2 matched groups of 196 patients .


Outcomes were compared using various statistics including interquartile range ( IQR ) , Kaplan-Meier curves , and adjusted Cox regression analysis .


Matched groups were found to be balanced except for N stage ( more N3 disease in SD ) , median treatment year ( SD in 2003 ; ID in 2007 ) , platinum and taxane chemotherapy ( SD in 28 % ; ID in 39 % ) , and median follow-up ( SD were 89 months ; ID were 40 months ) .


Median dose fractionation was 60 Gy/30 fr in SD ( BED 10 IQR : 72.0-75 .5 Gy ) and 66 Gy/33 fr ( BED 10 IQR : 78.6-79 .2 Gy ) in ID .


Survival curves for SD and ID matched cohorts were statistically similar ( P = .27 ) ; however , a nonstatistically significant trend toward better survival for ID was observed after 15 months ( median survival SD : 19.3 months ; ID : 21.0 months ) .


There was an increase in grades III to V lung toxicity associated with ID ( 13.0 % vs 4.9 % , respectively ) .


No significant overall survival benefits were found with intermediate DE ; however , more grade III or greater lung toxicity was observed .


The separation of survival curves after 15 months of follow-up suggests that a small overall survival improvement associated with intermediate DE can not be excluded .


Hochuekkito , a traditional herbal medicine , is occasionally prescribed in Japan to treat patients with a poor general condition .


We aimed to examine whether this medicine was beneficial and tolerable for patients with progressed pulmonary Mycobacterium avium complex ( MAC ) disease .


This pilot open-label quasi-randomized controlled trial enrolled 18 patients with progressed pulmonary MAC disease who had initiated antimycobacterial treatment over one year ago but were persistently culture-positive or intolerant .


All patients continued their baseline treatment regimens with ( n = 9 ) or without ( n = 9 ) oral Hochuekkito for 24 weeks .


Baseline characteristics were generally similar between the groups .


Most patients were elderly ( median age 70 years ) , female , had a low body mass index ( < 20 kg/m2 ) , and a long-term disease duration ( median approximately 8 years ) .


After the 24-week treatment period , no patient achieved sputum conversion .


Although the number of colonies in sputum tended to increase in the control group , it generally remained stable in the Hochuekkito group .


Radiological disease control was frequently observed in the Hochuekkito group than the control group ( 8/9 vs. 3/9 ; p = 0.05 ) .


Patients in the Hochuekkito group tended to experience increase in body weight and serum albumin level compared with those in the control group ( median body weight change : +0.4 kg vs. -0.8 kg ; median albumin change : +0.2 g/dl vs. 0.0 g/dl ) .


No severe adverse events occurred .


Hochuekkito could be an effective , feasible adjunct to conventional therapy for patients with progressed pulmonary MAC disease .


Future study is needed to explore this possibility .


UMIN Clinical Trials Registry UMIN000009920 .


While animal studies have shown better healing with a longer duration of protection without motion exercise after rotator cuff repair , supporting clinical studies are rare .


The purpose of this study was to assess the effect of immobilization following rotator cuff repair and to determine whether there was any difference in clinical outcome related to the duration of immobilization .


One hundred patients who underwent arthroscopic single-row repair of a posterosuperior rotator cuff tear ( mean , 2.3 cm in the coronal-oblique plane and 2.0 cm in the sagittal-oblique plane ) were prospectively randomized to be treated with immobilization for four or eight weeks .


During the immobilization period , no passive or active range-of-motion exercise , including pendulum exercise , was allowed .


According to the intention-to-treat protocol and full analysis set , eighty-eight patients were evaluated clinically and with magnetic resonance imaging postoperatively , after exclusion of twelve patients without postoperative clinical evaluation .


Ranges of motion , clinical scores , and retear rates were compared between the four and eight-week groups .


Ninety-eight patients were contacted by telephone at a mean of thirty-five months to investigate the clinical outcomes .


The mean duration of immobilization was 4.1 weeks in the four-week group and 7.3 weeks in the eight-week group .


There were nine full-thickness retears ( 10 % ) , and 89 % of the patients rated their result as excellent or good .


There were five full-thickness retears in the four-week group and four in the eight-week group ( p = 0.726 ) .


At the time of final follow-up , the two groups showed no differences in range of motion or clinical scores .


However , the proportion showing stiffness was higher in the eight-week group ( 38 % compared with 18 % , p = 0.038 ) .


Eight weeks of immobilization did not yield a higher rate of healing of medium-sized rotator cuff tears compared with four weeks of immobilization .


The optimal treatment for localised oesophageal squamous cell carcinoma ( SCC ) is uncertain .


We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy .


A feasibility RCT in three centres examined incident patients and reasons for ineligibility using multi-disciplinary team meeting records .


Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff .


Of 375 patients with oesophageal SCC , 42 ( 11.2 % ) were eligible .


Reasons for eligibility varied between centres , with significantly differing proportions of patients excluded because of total tumour length ( P = 0.002 ) .


Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms , balancing treatment arms and explaining the need for randomisation .


Before analyses of the qualitative data and recruiter training no patients were randomised .


Following training in one centre 5 of 16 eligible patients were randomised .


An RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients .


A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process .


We aimed to investigate the effects of verapamil and adenosine in an adjunct to intravenous tirofiban on management and prognosis of no-reflow phenomenon during primary percutaneous coronary intervention ( PPCI ) and to compare their efficacies on reversing of no-reflow phenomenon and short and midterm survival .


We included 46 patients with acute ST-segment elevation myocardial infarction ( STEMI ) and occurrence of no-reflow phenomenon after PPCI .


All patients received intravenous tirofiban and then randomized into one of the following 3 groups : intracoronary adenosine ( N. = 16 ) , intracoronary verapamil ( N. = 15 ) or placebo ( N. = 15 ) .


Intracoronary verapamil therapy had significant effect in restoring impaired coronary blood flow by decreasing thrombolysis in myocardial infarction ( TIMI ) frame count from 7344 to 5248 ( P = 0.024 ) .


However , adenosine and serum physiologic administration were not found to be so effective in decreasing TIMI frame count ( from 8135 to 7146 , P = 0.084 ; from 7432 to 7137 , P = 0.612 , respectively ) .


In-hospital and 6-month survival rates were similar among groups .


In conclusion , intracoronary verapamil restored the impaired coronary blood flow more effectively than adenosine or placebo .


However , none of them has changed the clinical course in the first 6 months .


Dyslipidemia is an established feature of metabolic syndrome ( MS ) that is associated with an increased risk of atherosclerotic cardiovascular disease .


Curcuminoids are natural products with anti-atherosclerotic and lipid-modifying effects but their efficacy in patients with MS has not yet been tested .


To investigate the effects of bioavailability-enhanced curcuminoids , as adjunctive to standard of care , on serum lipid concentrations in patients with MS.


Patients diagnosed with MS according to the NCEP-ATPIII criteria who were receiving standard of care were assigned to either curcuminoids ( C3 complex ( ) ; 1000 mg/day ; n = 50 ) or placebo ( n = 50 ; matched with drug capsules in shape and color ) for 8 weeks .


In order to improve the oral bioavailability , curcuminoids were co-administered with piperine ( bioperine ( ) ) in a ratio of 100:1 .


Serum concentrations of total cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides , small dense LDL ( sdLDL ) , lipoprotein ( a ) [ Lp ( a ) ] , and non-HDL-C were determined at baseline and at the end of 8-week treatment period .


Curcuminoids were more effective than placebo in reducing serum LDL-C , non-HDL-C , total cholesterol , triglycerides and Lp ( a ) , and elevating HDL-C concentrations .


However , changes in serum sdLDL levels were found to be comparable between the study groups .


The effects of curcuminoids on triglycerides , non-HDL-C , total cholesterol and Lp ( a ) remained significant after adjustment for baseline values of lipids and body mass index .


Curcuminoids-piperine combination is an efficacious adjunctive therapy in patients with MS and can modify serum lipid concentrations beyond what is achieved with standard of care .


A few studies focused on the methods of treatment for displaced distal tibial shaft fractures have been published , all of which compared two different methods .


In this randomized , prospective study , we aimed to compare minimally invasive plate osteosynthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation for distal tibial shaft fractures by assessing complications and secondary procedures .


From November 2002 to June 2012 , 137 skeletally mature patients with displaced distal tibial shaft fractures with or without fibula fracture were randomized to be treated by minimally invasive plate osteosynthesis ( group A , n = 46 ) , locking intramedullary nail ( group B , n = 46 ) or external fixation combined with limited open reduction and absorbable internal fixation ( group C , n = 45 ) .


Age , gender , mechanism of injury , fracture pattern and presence of open fracture were equally distributed among the three groups .


Indexes for evaluation included hospital stay , operative time , time to radiographic union , union status , infection and the incidence of re-operation .


Mazur ankle score was introduced for functional evaluation .


Statistics Analysis System ( SAS ) 9.2 was used for analysis .


A total of 121 patients were included in the final analysis ( group A 42 , group B 40 and group C 39 ) and evaluated after a mean of 14.8 months follow-up .


There was no significant difference ( P > 0.05 ) in hospital stay , time to radiographic union and the incidence of union status among the three groups .


Although group C was associated with less secondary procedures versus groups A and B , it was related with more pin tract infections ( 15.4 % ) .


Anterior knee pain occurred frequently after locking intramedullary nailing ( 37.5 % ) and the irritation symptoms were more frequently encountered in group A ( 59.5 % ) .


There was no difference in ankle function between the three methods after operation ( P > 0.05 ) .


We consider that the minimally invasive plate osteosynthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation techniques are all efficient methods for treating distal tibia fractures .


With its wide indications , external fixation combined with limited open reduction and absorbable internal fixation leads to minimal soft tissue complication , good functional result and no local soft tissue irritation or implant removal .


To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients .


This was a double-blind , randomized controlled study of children undergoing dental procedures .


Participants were randomly assigned to receive either Reiki therapy or the control therapy ( sham Reiki ) preoperatively .


Postoperative pain scores , opioid requirements , and side effects were assessed .


Family members were also asked about perioperative care satisfaction .


Multiple linear regressions were used for analysis .


Thirty-eight children participated .


The blinding procedure was successful .


No statistically significant difference was observed between groups on all outcome measures .


Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period .


This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients .


A better understanding of interrelations of exercise and improved eating , and their psychosocial correlates of self-efficacy , mood , and self-regulation , may be useful for the architecture of improved weight loss treatments .


Theory-based research within field settings , with samples possessing high probabilities of health risks , might enable rapid application of useful findings .


Adult volunteers with severe obesity ( body mass index [ BMI ] 35-50 kg/m ; age = 43.0 9.5 y ; 83 % female ) were randomly assigned to six monthly cognitive-behavioral exercise support sessions paired with either group-based nutrition education ( n = 145 ) or cognitive behavioral methods applied to improved eating ( n = 149 ) .


After specification of mediation models using a bias-corrected bootstrapping procedure , a series of reciprocal effects analyses assessed : a ) the reciprocal effects of changes in exercise and fruit and vegetable intake , resulting from the treatments , b ) the reciprocal effects of changes in the three psychosocial variables tested ( i.e. self-efficacy , mood , and self-regulation ) and fruit and vegetable change , resulting from change in exercise volume , and c ) the reciprocal effects of changes in the three psychosocial variables and exercise change , resulting from change in fruit and vegetable intake .


Mediation analyses suggested a reciprocal effect between changes in exercise volume and fruit and vegetable intake .


After inclusion of psychosocial variables , also found were reciprocal effects between change in fruit and vegetable intake and change in mood , self-efficacy for controlled eating , and self-regulation for eating ; and change in exercise volume and change in mood and exercise-related self-regulation .


Findings had implications for behavioral weight-loss theory and treatment .


Specifically , results suggested that treatments should focus upon , and leverage , the transfer effects from each of the primary weight-loss behaviors ( exercise and healthy eating ) to the other .


Findings on psychosocial correlates of these behavioral processes may also have practical applications .


Accruing evidence suggests that positive imagery-based cognitive bias modification ( CBM ) could have potential as a standalone targeted intervention for depressive symptoms or as an adjunct to existing treatments .


We sought to establish the benefit of this form of CBM when delivered prior to Internet cognitive behavioral therapy ( iCBT ) for depression


A randomized controlled trial ( RCT ) of a 1-week Internet-delivered positive CBM vs. an active control condition for participants ( N = 75 , 69 % female , mean age = 42 ) meeting diagnostic criteria for major depression ; followed by a 10-week iCBT program for both groups .


Modified intent-to-treat marginal and mixed effect models demonstrated no significant difference between conditions following the CBM intervention or the iCBT program .


In both conditions there were significant reductions ( Cohens d .57 -1.58 , 95 % CI = .12 -2.07 ) in primary measures of depression and interpretation bias ( PHQ9 , BDI-II , AST-D ) .


Large effect size reductions ( Cohens d .81 -1.32 , 95 % CI = .31 -1.79 ) were observed for secondary measures of distress , disability , anxiety and repetitive negative thinking ( K10 , WHODAS , STAI , RTQ ) .


Per protocol analyses conducted in the sample of participants who completed all seven sessions of CBM indicated between-group superiority of the positive over control group on depression symptoms ( PHQ9 , BDI-II ) and psychological distress ( K10 ) following CBM ( Hedges g .55 -.88 , 95 % CI = -.03 -1.46 ) and following iCBT ( PHQ9 , K10 ) .


The majority ( > 70 % ) no longer met diagnostic criteria for depression at 3-month follow-up .


The control condition contained many active components and therefore may have represented a smaller ` dose ' of the positive condition .


Results provide preliminary support for the successful integration of imagery-based CBM into an existing Internet-based treatment for depression .


Nonsevere relapses are more common than severe relapses in antineutrophil cytoplasmic antibody ( ANCA ) - associated vasculitis ( AAV ) , but their clinical course and treatment outcomes remain largely unexamined .


We undertook this study to analyze the outcomes of patients with nonsevere relapses in the Rituximab in ANCA-Associated Vasculitis ( RAVE ) trial who were treated with prednisone according to a prespecified protocol .


RAVE was a randomized , double-blind , placebo-controlled trial comparing rituximab ( RTX ) to cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) for induction of remission .


Patients who experienced nonsevere relapses between months 1 and 18 were treated with a prednisone increase without a concomitant change in their nonglucocorticoid immunosuppressants , followed by a taper .


Forty-four patients with a first nonsevere relapse were analyzed .


In comparison to the 71 patients who maintained relapse-free remission over 18 months , these patients were more likely to have proteinase 3-ANCAs , diagnoses of granulomatosis with polyangiitis ( Wegener 's ) , and a history of relapsing disease at baseline .


A prednisone increase led to remission in 35 patients ( 80 % ) .


However , only 13 patients ( 30 % ) were able to maintain second remissions through the followup period ( mean 12.5 months ) ; 31 patients ( 70 % ) had a second disease relapse , 14 of them with severe disease .


The mean time to second relapse was 9.4 months ( 4.7 months in the group treated with RTX versus 13.7 months in the group treated with CYC/AZA ; P < 0.01 ) .


Patients who experienced nonsevere relapses received more glucocorticoids than those who maintained remission ( 6.7 grams versus 3.8 grams ; P < 0.01 ) .


Treatment of nonsevere relapses in AAV with an increase in glucocorticoids is effective in restoring temporary remission in the majority of patients , but recurrent relapses within a relatively short interval remain common .


Alternative treatment approaches are needed for this important subset of patients .


The incidence of alkaline reflux gastritis ( ARG ) after pancreaticoduodenectomy ( PD ) is high .


Although Braun enteroenterostomy ( BEE ) may reduce ARG , BEE may result in marginal ulcers ( MUs ) due to the additional anastomotic stoma .


We conducted this study to compare clinical outcomes of using a modified BEE ( MBEE ) with traditional gastrojejunostomy ( TGJ ) , by inducting a purse-string suture instead of an additional anastomotic stoma .


All 62 patients underwent standard PD at the Department of Hepatobiliopancreatic Surgery of West China Hospital between January 1 , 2008 and January 31 , 2012 .


Demographics , perioperative and postoperative factors , and follow-up morbidity were compared in those patients who underwent MBEE ( n = 32 , three patients were lost to follow-up ) to those who underwent TGJ ( n = 30 , nine patients were lost to follow-up ) .


Patients who underwent the MBEE experienced a decrease in total morbidity including ARG and MUs , relative to those who underwent TGJ ( 24.1 % versus 58.3 % , P = 0.011 ) .


With regard to the MBEE group , the total ARG rate was statistically significantly lower compared with the TGJ group ( 13.8 % versus 37.5 % , P = 0.046 ) .


In addition , the incidence of MUs was reduced .


In patients undergoing PD , the MBEE was safely performed with significantly more patients having reduced incidence of ARG and related sequela compared with those who underwent TGJ .


These results support further study of patients undergoing gastroenterostomy after resection of the distal stomach in larger , randomized studies .


To assess the effect of platelet-rich fibrin ( PRF ) on postoperative pain , swelling , trismus , periodontal healing on the distal aspect of the secondmolar , and progress of bone regeneration in mandibular third molar extraction sockets .


Over a 2-year period , 31 patients ( mean age , 26.1 yr ) who required surgical extraction of a single impacted third molar and met the inclusion criteria were recruited .


After surgical extraction of the third molar , only primary closure was performed in the control group , whereas PRF was placed in the socket followed by primary closure in the case group ( 16 patients ) .


The outcome variables were pain , swelling , maximum mouth opening , periodontal pocket depth , and bone formation , with a follow-up period of 3months .


Quantitative data are presented as mean .


Statistical significance was inferred at a P value less than .05 .


Pain ( P = .017 ) , swelling ( P = .022 ) , and interincisal distance ( P = .040 ) were less in the case group compared with the control group on the first postoperative day .


Periodontal pocket depth decreased at 3months postoperatively in the case ( P < .001 ) and control ( P = .014 ) groups , and this decrease was statistically significant .


Bone density scores at 3months postoperatively were higher in the case group than in the control group , but this difference was not statistically important .


The application of PRF lessens the severity of immediate postoperative sequelae , decreases preoperative pocket depth , and hastens bone formation .


Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination .


The main cause of vertigo in primary care is benign paroxysmal positional vertigo ( BPPV ) , which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers .


The objective of this study is to evaluate the effectiveness of Epley 's maneuver performed by general practitioners ( GPs ) in the treatment of BPPV .


This study is a randomized clinical trial conducted in the primary care setting .


The study 's scope will include two urban primary care centers which provide care for approximately 49,400 patients .


All patients attending these two primary care centers , who are newly diagnosed with benign paroxysmal positional vertigo , will be invited to participate in the study and will be randomly assigned either to the treatment group ( Epley 's maneuver ) or to the control group ( a sham maneuver ) .


Both groups will receive betahistine .


Outcome variables will be : response to the D-H test , patients ' report on presence or absence of vertigo during the previous week ( dichotomous variable : yes/no ) , intensity of vertigo symptoms on a Likert-type scale in the previous week , total score on the Dizziness Handicap Inventory ( DHI ) and quantity of betahistine taken .


Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners ( GPs ) and , therefore , its widespread practice may contribute to improve the quality of life of BPPV patients .


ClinicalTrials.gov Identifier : NCT01969513 .


The aim of this study was to develop an accurate robust testing method to simultaneously measure urine levels of HVA and VMA using gas chromatography mass spectrometry ( GCMS ) and to establish age-specific reference intervals of HVA and VMA in random urines for Vietnamese children .


The assay for urinary HVA and VMA was developed based on a classical urinary organic acid profiling method .


Briefly , this incorporated 3-phenyl butyric acid as the internal standard and liquid-liquid extraction with ethyl acetate followed by derivatization with BSTFA .


The Agilent 7890A GC and 5975C Mass Selective Detector in single ion monitoring mode was used for analysis .


Reference intervals were developed from random urine samples collected from 634 disease free Vietnamese children and compared to 50 known neuroblastoma patient samples .


Results were reported relative to creatinine concentration .


Age related 95 % reference intervals for urinary HVA and VMA were estimated from sample quantiles .


The analytes ( expressed as analyte/creatinine ratios ) diagnostic values were determined by calculating the related sensitivity , specificity and likelihood ratios .


HVA and VMA were linear to at least 193 and 221mol/L , respectively .


The limit of quantitation for both analytes was 0.9 mol/L .


Using the bi-level control ( n = 15 ) , the within-batch coefficients of variations ( CVs ) were less than 3 % for both analytes across the assay range .


The between-batch CVs ( n = 20 over three months ) , were 3.6 % at 11mol/L and 2.1 % at 88mol/L for HVA , 6.6 % at 18.2 mol/L and 2.6 % at 90.6 mol/L for VMA .


Vietnamese age related reference intervals were established for urinary HVA and VMA per creatinine .


HVA for children < 6months ( n = 91 ) was 5.3-37 .0 mol/mmol ; 6months to < 1year ( n = 141 ) was 2.7-27 .7 mol/mmol ; 1 to 5years ( n = 139 ) was 3.4-17 .9 mol/mmol ; 6 to 10years ( n = 136 ) was 2.7-8 .8 mol/mmol ; and 11 to 15years ( n = 127 ) was 1.1-9 .4 mol/mmol .


VMA for children < 6months was 1.8-12 .2 mol/mmol ; 6months to < 1year was 1.5-9 .3 mol/mmol ; 1 to 5years was 1.9-7 .8 mol/mmol ; 6 to 10years was 1.6-5 .1 mol/mmol ; and 11 to 15years was < 0.9-6 .3 mol/mmol .


A robust testing method for simultaneous quantitation of urinary HVA and VMA by GCMS was developed .


This method is accurate , precise and fit for its clinical purpose and suitable for developing countries .


Age-related reference intervals of urinary HVA and VMA were established for Vietnamese children and the intervals declined progressively with increasing age for each analyte .


Contrast-induced nephropathy ( CIN ) is one of the major causes of new-onset renal failure in hospitalized patients .


Although renin-angiotensin-aldosterone system ( RAAS ) blocking agents are widely used among patients requiring contrast studies , data on the effect of these agents on the development of CIN are sparse and inconsistent .


To evaluate in a randomized controlled trial whether uninterrupted administration of angiotensin II ( AnglI ) blockade medications influence estimated glomerular filtration rate ( eGFR ) in patients undergoing non-emergent coronary angiography .


Patients receiving treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACE-I/ARB ) were recruited consecutively .


The enrolled subjects were randomized into three groups at a 1:1:1 ratio : group A ( ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure ) , group B ( ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure ) , and group C ( ACE/ARB continued throughout the study period ) .


Plasma creatinine was measured and eGFR was calculated according to the Cockroft-Gault equation before and 48 hours after the coronary angiography .


The primary endpoint was a change in eGFR at 48 hours .


Groups A , B and C comprised 30 , 31 and 33 patients respectively .


The mean age of the study population was 65 + / - 12 years and 67 % were males .


Fifty percent of the subjects had diabetes mellitus .


The primary endpoint analysis showed that at 48 hours after the procedure there was no difference in delta eGFR between groups A and C ( 4.25 + / - 12.19 vs. 4.65 + / - 11.76 , P = 0.90 ) and groups B and C ( 3.72 + / - 17.42 vs. 4.65 + / - 11.76 , P = 0.82 ) .


In post-hoc analysis the patients were clustered according to the following groups : medical alternation ( group A and B ) versus control ( group C ) , and to baseline eGFR > or = 60 ml/min vs. eGFR ( < 60 ml/min .


In patients with baseline eGFR < 60 ml/min the delta eGFR ( baseline eGFR-eGFR 48 hours post-angiography ) was significantly different between the intervention vs. control group ( median 5.61 vs. median -2.19 , P = 0.03 respectively ) .


While in patients with baseline eGFR > or = 60 ml/min there was no significant difference in delta eGFR between the intervention and control groups .


ACE-I and ARB can safely be used before and after coronary angiography in patients with eGFR > or = 60 ml/min .


The purpose of this study was to investigate the use of vaginal progesterone for the prevention of preterm delivery in twin pregnancies .


We conducted a prospective , randomized , double-blind , placebo-controlled trial that involved 390 naturally conceived twin pregnancies among mothers with no history of preterm delivery who were receiving antenatal care at a single center .


Women with twin pregnancies between 18 and 21 weeks and 6 days ' gestation were assigned randomly to daily vaginal progesterone ( 200 mg ) or placebo ovules until 34 weeks and 6 days ' gestation .


The primary outcome was the difference in mean gestational age at delivery ; the secondary outcomes were the rate of spontaneous delivery at < 34 weeks ' gestation and the rate of neonatal composite morbidity and mortality in the treatment and nontreatment groups .


The baseline characteristics were similar in both groups .


The final analysis included 189 women in the progesterone group and 191 in the placebo group .


No difference ( P = .095 ) in the mean gestational age at delivery was observed between progesterone ( 35.08 3.19 [ SD ] ) and placebo groups ( 35.55 2.85 ) .


The incidence of spontaneous delivery at < 34 weeks ' gestation was 18.5 % in the progesterone group and 14.6 % in the placebo group ( odds ratio , 1.32 ; 95 % confidence interval , 0.24-2 .37 ) .


No difference in the composite neonatal morbidity and mortality was observed between the progesterone ( 15.5 % ) and placebo ( 15.9 % ) groups ( odds ratio , 1.01 ; 95 % confidence interval , 0.58-1 .75 ) .


In nonselected twin pregnancies , vaginal progesterone administration does not prevent preterm delivery and does not reduce neonatal morbidity and death .


To investigate the effect of Vitamin D3 on physical performance in patients with HF .


HF is associated with functional decline and frailty .


Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF .


Sixty-four patients participated in a 6-month parallel design double blind RCT to test the hypothesis that oral vitamin D3 would improve physical performance .


Vitamin D3 50,000 IU or placebo was given weekly ; all received daily calcium .


Patients were included regardless of EF and 25OHD 37.5 ng/ml .


The primary outcome was peak VO2 , and secondary outcomes were the 6MW , TGUG and knee isokinetic muscle strength .


Between group comparisons were made using ANCOVA models that adjust for baseline measures .


Patients were age 65.9 10.4 years old , 48 % women , 64 % African American , EF 37.613.9 , 36 % NYHA III , the remainder NYHA II .


At baseline the vitamin D group 25OHD was 19.1 9.3 ng/ml and increased to 61.7 20.3 ng/ml ; in the placebo group baseline 25OHD was 17.8 9.0 ng/ml and decreased to 17.4 9.8 ng/ml at 6 months ( between groups p < 0.001 ) .


There was no significant change from baseline to 6 months in peak VO2 , 6MW , TGUG or isokinetic muscle strength .


Vitamin D3 did not improve physical performance for patients with HF despite a robust increase in serum 25OHD .


Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation .


In nutritional studies , pigs are often used as models for humans because of nutritional and physiologic similarities .


However , evidence supporting similar metabolic responses to nutritional interventions is lacking .


The objective was to establish whether pigs and humans respond similarly to a nutritional intervention .


Using metabolomics , we compared the acute metabolic response to 4 test breads between conventional pigs ( growing ) and adult human subjects ( with the metabolic syndrome ) .


Six catheterized pigs and 15 human subjects were tested in a randomized crossover design with 4 breads : white-wheat bread low in dietary fiber , rye bread with whole-rye kernels , and 2 white-wheat breads supplemented with either wheat arabinoxylan or oat - glucan .


Blood samples drawn -15 , 30 , and 120 min postprandially were analyzed by untargeted liquid chromatography-mass spectrometry metabolomics .


We found that the postprandial responses , as reflected in blood metabolomes , are similar in pigs and humans .


Twenty-one of 26 identified metabolites that were found to be different between the species were qualitatively similar in response to the test breads , despite different basal metabolome concentrations in the plasma of pigs and humans .


Humans had higher contents of phosphatidylcholines , oleic acid , and carnitine in plasma , possibly reflecting a higher intake of meats and fats .


In pigs , betaine , choline , creatinine , tryptophan , and phenylalanine were higher , probably because of the higher doses of bread provided to the pigs ( per kg body weight ) and/or because of their growing status .


Acute metabolic differences in these metabolites induced by the breads were , however , comparable between the 2 species .


Our results indicate that pigs are a suitable model for human metabolic studies in food research .


The human trial was registered at clinicaltrials.gov as NCT01316354 .


The animal experiment was conducted according to a license obtained by the Danish Animal Experiments Inspectorate , Ministry of Food , Agriculture and Fisheries , Danish Veterinary and Food Administration .


The extent to which change in physical activity can modify the risk of cardiovascular disease in individuals at high cardiovascular risk is uncertain .


We investigated whether baseline and change in objectively-assessed ambulatory activity is associated with the risk of a cardiovascular event in individuals at high cardiovascular risk with impaired glucose tolerance .


We assessed prospective data from the NAVIGATOR trial involving 9306 individuals with impaired glucose tolerance who were recruited in 40 countries between January , 2002 , and January , 2004 .


Participants also either had existing cardiovascular disease ( if age 50 years ) or at least one additional cardiovascular risk factor ( if age 55 years ) .


Participants were followed-up for cardiovascular events ( defined as cardiovascular mortality , non-fatal stroke , or myocardial infarction ) for 6 years on average and had ambulatory activity assessed by pedometer at baseline and 12 months .


Adjusted Cox proportional hazard models quantified the association of baseline and change in ambulatory activity ( from baseline to 12 months ) with the risk of a subsequent cardiovascular event , after adjustment for each other and potential confounding variables .


This study is registered with ClinicalTrials.govNCT00097786 .


During 45,211 person-years follow-up , 531 cardiovascular events occurred .


Baseline ambulatory activity ( hazard ratio [ HR ] per 2000 steps per day 090 , 95 % CI 084-096 ) and change in ambulatory activity ( 092 , 086-099 ) were inversely associated with the risk of a cardiovascular event .


Results for change in ambulatory activity were unaffected when also adjusted for changes in body-mass index and other potential confounding variables at 12 months .


In individuals at high cardiovascular risk with impaired glucose tolerance , both baseline levels of daily ambulatory activity and change in ambulatory activity display a graded inverse association with the subsequent risk of a cardiovascular event .


Novartis Pharmaceuticals .


Homozygous familial hypercholesterolaemia is a rare , serious disorder caused by very low or absent plasma clearance of LDL , substantially raised LDL cholesterol , and accelerated development of cardiovascular disease .


Conventional lipid-lowering treatments are modestly effective .


Evolocumab , a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , reduced LDL cholesterol by 16 % in a pilot study .


We now report results with evolocumab in a randomised , double-blind , placebo-controlled phase 3 trial .


This randomised , double-blind , placebo-controlled phase 3 trial was undertaken at 17 sites in ten countries in North America , Europe , the Middle East , and South Africa .


50 eligible patients ( aged 12 years ) with homozygous familial hypercholesterolaemia , on stable lipid-regulating therapy for at least 4 weeks , and not receiving lipoprotein apheresis , were randomly allocated by a computer-generated randomisation sequence in a 2:1 ratio to receive subcutaneous evolocumab 420 mg or placebo every 4 weeks for 12 weeks .


Randomisation was stratified by LDL cholesterol at screening ( < 11 mmol/L or 11 mmol/L ) and implemented by a computerised interactive voice-response system .


Patients , study personnel , and the funder were masked to treatment and to the efficacy results by the central laboratory not returning LDL cholesterol or any lipid results to the clinical sites after the baseline visit .


The primary endpoint was percentage change in ultracentrifugation LDL cholesterol from baseline at week 12 compared with placebo , analysed by intention-to-treat .


This trial is registered with ClinicalTrials.gov , number NCT01588496 .


Of the 50 eligible patients randomly assigned to the two treatment groups , 49 actually received the study drug and completed the study ( 16 in the placebo group and 33 in the evolocumab group ) .


Compared with placebo , evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 309 % ( 95 % CI -439 % to -180 % ; p < 00001 ) .


Treatment-emergent adverse events occurred in ten ( 63 % ) of 16 patients in the placebo group and 12 ( 36 % ) of 33 in the evolocumab group .


No serious clinical or laboratory adverse events occurred , and no anti-evolocumab antibody development was detected during the study .


In patients with homozygous familial hypercholesterolaemia receiving stable background lipid-lowering treatment and not on apheresis , evolocumab 420 mg administered every 4 weeks was well tolerated and significantly reduced LDL cholesterol compared with placebo .


Amgen Inc. .


Dynamic rehabilitation has been suggested to be an important part of nonoperative treatment of acute Achilles tendon rupture that results in functional outcome and rerupture rates comparable with those of operative treatment .


However , the optimal role of weight-bearing during early rehabilitation remains unclear .


The purpose of this study was to compare immediate weight-bearing with non-weight-bearing in a nonoperative dynamic treatment protocol for Achilles tendon rupture .


The study was conducted as a blinded , randomized , controlled , parallel superiority trial .


Patients eighteen to sixty years of age were eligible for inclusion .


Both groups were treated nonoperatively with controlled early motion .


The intervention group was allowed full weight-bearing from day one , and the control group was non-weight-bearing for six weeks .


The primary outcome was the Achilles tendon Total Rupture Score ( ATRS ) after one year .


Secondary outcomes included heel-rise work , health-related quality of life , and the rerupture rate .


Outcome assessors were blinded to the intervention .


Thirty patients were randomized to each group ; twenty-nine in the weight-bearing group and twenty-seven in the control group were analyzed .


The only significant difference between the groups was better health-related quality of life in the weight-bearing group at twelve months ( p = 0.009 ) .


The mean ATRS at twelve months was 73 in the weight-bearing group and 74 in the control group ( p = 0.81 ) .


At twelve months , the total heel-rise work performed by the injured limb relative to that by the uninjured limb was 53 % in the weight-bearing group and 58 % in the control group ( p = 0.37 ) .


There were three reruptures in the weight-bearing group and two in the control group ( p = 1.0 ) .


The ATRS and heel-rise work results did not differ significantly between the groups .


The rerupture rate was 9 % overall , and both groups had substantial functional deficits in the injured limb compared with the uninjured limb .


Immediate weight-bearing can be recommended as an option in the nonoperative treatment of Achilles tendon rupture .


To evaluate the potential efficacy and safety of inner limiting membrane ( ILM ) staining with brilliant blue G ( BBG ) under air infusion .


63 patients , treated by one surgeon with macular hole or idiopathic epiretinal membrane were evaluated prospectively .


BBG was applied under air infusion in 38 patients ( group 1 ) , and injected into the vitreous cavity in 25 ( group 2 ) .


Main outcome measures were the chromaticity difference between the stained ILM and the unstained underlying retina , anatomical-functional outcomes and complications of the surgery .


Chromaticity difference was measured by an objective and quantitative analysis method to describe colour contrast strengths as they are perceived by the human eye .


Anatomical and functional outcomes were assessed using optical coherence tomography ( OCT ) , visual field analyses ( VFA ) and multifocal electroretinography ( mfERG ) .


CIELAB scores showed a significantly superior contrast for group 1 ( 16.722.36 ) than group 2 ( 10.341.29 ) ( p < 0.001 ) .


Visual acuity had increased in 28 eyes and remained stable in 10 eyes in group 1 .


In group 2 , visual acuity had improved in 17 patients and remained unchanged in 8 patients .


Based on postoperative OCT , anatomical success rate was 100 % .


During the follow-up period , mfERG and VFA demonstrated no case of BBG toxicity in either group .


Cataract progression was the main postoperative complication ( six eyes in group 1 and four eyes in group 2 ) and did not show a significant difference between the groups ( p = 0.45 ) .


BBG under air infusion yields a significantly higher contrast staining and easy peeling of ILM associated with anatomical and functional improvement and no retinal toxicity after macular surgery .


To investigate whether a home-based rehabilitation program for community-dwelling older people with recent hip fracture is more effective than standard care in improving mobility recovery and reducing disability .


Randomized , controlled , parallel-group trial .


Rehabilitation in participants ' homes ; measurements in university-based laboratory and local hospital .


Clinical population of community-dwelling men and women ( aged 60 + ) recovering from hip fracture .


Participants were randomly assigned into control ( n = 41 ) or intervention ( n = 40 ) groups on average 42 23 days after discharge home .


A yearlong multicomponent home-based rehabilitation aimed at promoting mobility recovery and physical functional capacity after hip fracture .


The intervention included evaluation and modification of environmental hazards , guidance for safe walking , nonpharmacological pain management , a progressive home exercise program , physical activity counseling , and standard care .


Measurements were outlined according to the tiers of the disablement process , with the ability to negotiate stairs as the main outcome .


Prefracture ability to negotiate stairs was enquired at the hospital on average 10 5 days after fracture .


Subsequently , current perceived ability to negotiate stairs was reported immediately before the intervention ( on average 9 weeks after surgery ) and 3 , 6 , and 12 months thereafter .


Other measurements included leg extension power deficit ( LEP ) , functional balance ( Berg Balance Scale ) and lower extremity performance ( Short Physical Performance Battery ) .


Effects of the intervention were analyzed with generalized estimation equations and longitudinal repeated measures mixture path models .


The intervention reduced perceived difficulties in negotiating stairs ( interaction , group time P = .001 ) from prefracture to 12 months compared with the control condition .


The mixture path model revealed that less difficulty in negotiating stairs at 6 and 12 months correlated with better functional balance at 3 and 6 months in the intervention group but not controls ( group difference P = .007 and P < .001 , respectively ) .


The individualized home-based rehabilitation program improved mobility recovery after hip fracture over standard care .


To be efficacious in reducing or reversing disability after hip fracture , rehabilitation needs to be individualized , include many components , be progressive , and span a sufficiently long period .


Current Controlled Trials ( ISRCTN53680197 ) .


Patients leaving residential treatment for alcohol use disorders are not typically offered evidence-based continuing care , although research suggests that continuing care is associated with better outcomes .


A smartphone-based application could provide effective continuing care .


To determine whether patients leaving residential treatment for alcohol use disorders with a smartphone application to support recovery have fewer risky drinking days than control patients .


An unmasked randomized clinical trial involving 3 residential programs operated by 1 nonprofit treatment organization in the Midwestern United States and 2 residential programs operated by 1 nonprofit organization in the Northeastern United States .


In total , 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment were randomized to treatment as usual ( n = 179 ) or treatment as usual plus a smartphone ( n = 170 ) with the Addiction-Comprehensive Health Enhancement Support System ( A-CHESS ) , an application designed to improve continuing care for alcohol use disorders .


Treatment as usual varied across programs ; none offered patients coordinated continuing care after discharge .


A-CHESS provides monitoring , information , communication , and support services to patients , including ways for patients and counselors to stay in contact .


The intervention and follow-up period lasted 8 and 4 months , respectively .


Risky drinking days -- the number of days during which a patient 's drinking in a 2-hour period exceeded 4 standard drinks for men and 3 standard drinks for women , with standard drink defined as one that contains roughly 14 g of pure alcohol ( 12 oz of regular beer , 5 oz of wine , or 1.5 oz of distilled spirits ) .


Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4 , 8 , and 12 months after discharge from residential treatment .


For the 8 months of the intervention and 4 months of follow-up , patients in the A-CHESS group reported significantly fewer risky drinking days than did patients in the control group , with a mean of 1.39 vs 2.75 days ( mean difference , 1.37 ; 95 % CI , 0.46-2 .27 ; P = .003 ) .


The findings suggest that a multifeatured smartphone application may have significant benefit to patients in continuing care for alcohol use disorders .


clinicaltrials.gov Identifier : NCT01003119 .


Hemostasis in thyroid surgery is of utmost importance for a successful surgery and an uneventful postoperative course .


Our aim was to evaluate the effectiveness of the FOCUS Harmonic Scalpel in patients undergoing open total thyroidectomy .


In this study , 778 patients were randomized into 2 groups based on the surgical technique used : group I comprised the conventional clamp-and-tie technique , group II comprised patients in whom the FOCUS Harmonic Scalpel was used exclusively .


The groups were compared in regard to surgical time , complications , and hospital stay .


Surgical time was significantly lower in group II compared with group I ( 7921.5 min vs. 12530.4 , respectively , P < 0.001 ) .


Twenty-seven patients ( 6.94 % ) in group I experienced symptomatic hypocalcemia requiring calcium and/or vitamin D therapy versus 14 patients ( 3.6 % ) in group II , with statistically significant difference ( P < 0.05 ) .


Mean post-operative hospital stay was significantly lower in group II compared with group I ( 2.60.9 vs. 2.91.0 ; P < 0.001 ) .


The FOCUS Harmonic Scalpel can shorten operative time and hospital stay , reduce incidence of symptomatic hypocalcemia but not transient hypoparathyroidism , and show no significance on recurrent nerve injury .


FOCUS Harmonic Scalpel is supposed to be a more reliable and safe instrument that can take place of the clamp-and-tie technique in total thyroidectomy .


This study aimed at evaluating the benefit of changing drug therapy in elderly patients with moderate , potentially drug-induced hyponatremia .


Hospitalized older adults , with moderate hyponatremia , potentially induced by drugs , were randomized into two arms : an interventional group , whose drug therapy was changed , and a reference group , which received standard care .


The effectiveness of the intervention was evaluated by the normalization of serum sodium after four weeks and by the incidence of falls three months later .


Nineteen patients were randomized , fourteen evaluated at 4 weeks .


Serum sodium was normalized more frequently in the interventional group than in the reference group : 75 % ( 6/8 ) IC95 % [ 35-97 ] versus 0 % ( 0/6 ) IC95 % [ 0-46 ] ; p = 0.01 .


A greater reduction in falls occurred in the therapeutic intervention group 75 % ( 3/4 ) IC95 % [ 19-99 ] versus 0 % ( 0/5 ) IC95 % [ 0-52 ] ; p = 0.048 .


This study showed the biological and clinical benefit of a pharmalogical intervention .


Registration number of the study : ID RCB 2010-A00778-31 .


Knot tying is a fundamental and crucial surgical skill .


We developed a kinesthetic pedagogical approach that increases precision and economy of motion by explicitly teaching suture-handling maneuvers and studied its effects on novice performance .


Seventy-four first-year medical students were randomized to learn knot tying via either the traditional or the novel `` kinesthetic '' method .


After 1 week of independent practice , students were videotaped performing 4 tying tasks .


Three raters scored deidentified videos using a validated visual analog scale .


The groups were compared using analysis of covariance with practice knots as a covariate and visual analog scale score ( range , 0 to 100 ) as the dependent variable .


Partial eta-square was calculated to indicate effect size .


Overall rater reliability was .92 .


The kinesthetic group scored significantly higher than the traditional group for individual tasks and overall , controlling for practice ( all P < .004 ) .


The kinesthetic overall mean was 64.15 ( standard deviation = 16.72 ) vs traditional 46.31 ( standard deviation = 16.20 ; P < .001 ; effect size = .28 ) .


For novices , emphasizing kinesthetic suture handling substantively improved performance on knot tying .


We believe this effect can be extrapolated to more complex surgical skills .


The purpose of this study was to determine whether the occurrence of numerous colonic bubbles during CT colonography ( CTC ) performed with polyethylene glycol cleansing and oral iohexol fecal/fluid tagging could be prevented by use of simethicone .


Adults with suspected colonic neoplasia who had been randomly assigned to control and simethicone intervention groups underwent CTC after cleansing with 4 L of polyethylene glycol , tagging with 50 mL of 350 mg I/mL oral iohexol , and without ( control ) or with ( intervention ) oral administration of 200 mg of simethicone .


Colonic segments in the control and intervention groups were evaluated for amount of colonic bubbles during CTC .


A 6-point grading system was used in which 0 indicated no bubbles and 5 indicated that more than three fourths of the air-distended mucosa was covered with bubbles .


The primary endpoint was a per-patient colonic bubble grade , derived as an average of the segmental grades .


Eighty adults with suspected colonic neoplasia were randomly assigned to the control ( 40 patients ) and simethicone intervention ( 40 patients ) groups .


A total of 659 colonic segments in the control group and 689 segments in the intervention group were evaluated for amount of colonic bubbles during CTC .


The per-patient colonic bubble score was significantly lower in the simethicone intervention group than in the control group .


The mean score was 0.00.1 ( SD ) versus 1.20.8 ( p < 0.001 ; 95 % CI for the mean difference , -1.4 to -1.0 ) .


In the intervention group , 673 ( 97.7 % ) segments were grade 0 , and 16 ( 2.3 % ) were grade 1 .


In contrast , in the control group , 226 ( 34.3 % ) segments were grade 0 ; 173 ( 26.3 % ) , grade 1 ; 175 ( 26.6 % ) , grade 2 ; 45 ( 6.8 % ) , grade 3 ; 23 ( 3.5 % ) , grade 4 ; and 17 ( 2.6 % ) , grade 5 .


The colonic bubbles associated with fecal/fluid tagging with iohexol can be successfully prevented by adding simethicone to the colonic preparation .


To compare the difference in clinical efficacy on post-stroke sensory disturbance between catgut implantation at scalp reflecting foci and conventional acupuncture as well as the impacts on blood rheology .


Fifty-nine cases of post-stroke sensory disturbance were randomized into a catgut implantation group ( 30 cases ) and an acupuncture group ( 29 cases ) .


The conventional internal medicine treatment , limb motor function rehabilitation training and sensory function training were applied in the two groups .


Additionally , the catgut implantation was used at scalp reflecting foci in the catgut implantation group , once a week , 4 treatment made one session .


In the acupuncture group , acupuncture was applied at Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Waiguan ( TE 5 ) , Hegu ( LI 4 ) , Siqiang ( EX-LE 24 ) , Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Fenglong ( ST 40 ) , Qiuxu ( GB 40 ) and Taichong ( LR 3 ) , once every day , 5 times a week , the 4 weeks of treatment made one session .


There was an interval of 1 week between the two sessions in the two groups .


Totally , 2 sessions of treatment were required .


Before and after treatment , the sensory and motor scores , modified barthel index ( MBI ) and blood rheological indices were observed , and the clinical efficacy was evaluated in the patients of the two groups .


After 8 weeks of treatment , the total effective rate was 90.0 % ( 27/30 ) in the catgut implantation group , which was better than 65.5 % ( 19/29 ) in the acupuncture group ( P < 0.05 ) .


FugI-Meyer motor function , sensory function scores and MBI were all improved as compared with those before treat ment in the two groups ( all P < 0.05 ) , and the results in the catgut implantation group was superior to the acu puncture group ( all P < 0.05 ) .


The levels of whole blood viscosity , erythrocyte hematocrit , platelet aggregation and fibrinogen were improved as compared with those before treatment ( all P < 0.05 ) , and the results in the catgut implantation group was better than those in the acupuncture group ( all P < 0.05 ) .


The catgut implantation at scalp reflecting foci achieves a satisfactory clinical efficacy on post-stroke sensory disturbance and improves the blood rheological indices .


Adherence to the Heart Failure Society of America ( HFSA ) 2010 guidelines recommending 30 minutes of supervised moderate intensity exercise five days per week is difficult for patients with heart failure ( HF ) .


Innovative programs are needed to assist HF patients to adhere to long-term exercise .


The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of a behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure .


A sample size of 246 subjects with heart failure will be recruited over a 3 year period .


All subjects receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization .


Subjects completing at least 6 of 9 training sessions are randomized to the HEART Camp Intervention group ( HC ) or to a standard care ( SC ) exercise group .


The HC intervention group receives cognitive-behavioral strategies that address the intervention components of knowledge , attitudes , self-efficacy , behavioral self-management skills and social support .


The SC group is provided access to the exercise facility and regular facility staff for the 18 month study period .


The primary aim is to evaluate the effect of HEART Camp on adherence to exercise , with our central hypothesis that the HC group will have significantly better adherence to exercise at 18 months .


Secondary aims include evaluating which components of the HEART Camp intervention mediate the effects of the intervention on adherence ; evaluating the effect of HEART Camp on specific health outcomes ; exploring selected demographic variables ( race , gender , age ) as potential moderators of the effect of the HEART Camp intervention on adherence ; and exploring the perceptions and experiences that contextualize exercise adherence .


The HEART Camp intervention is the first to test a multi-component intervention designed to improve long-term adherence to exercise behavior in patients with HF .


Improving long-term adherence to exercise is the logical first step to ensure the required dose of exercise that is necessary to realize beneficial health outcomes and reduce costs in this burdensome chronic illness .


Clincaltrials.gov NCT01658670 .


Chronic gastritis ( CG ) , a poorly understood entity , is a very common disease of the digestive tract and is difficult to cure .


Chronic non-atrophic gastritis ( CNG ) is the most common type of CG .


Even if treated with current standard chemotherapy , some patients will not be freed from this confusing disease .


Many studies have shown traditional Chinese medicine ( TCM ) is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified .


However , the studies that have been carried out were not scientifically rigorous trials .


Our aim is to design a high-quality trial for a new TCM drug , the Jian-Wei-Qu-Tong Pills ( JWQTP ) , to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome ( SSQDDSS ) .


This is a phase II , multicenter , parallel-group , double-blind , randomized and placebo-controlled trial .


A total of 240 participants will be assigned to a high-dose group , a low-dose group or a placebo control group with a 1:1:1 ratio at five sites .


Then , one dose ( six 1-g pills ) , with a variable ratio between real drug and dummy drug according to the intervention protocol , will be taken three times a day before each meal for 8 weeks .


The primary outcome is the eradication rate of epigastric pain .


The secondary outcome includes the changes of endoscopic examination , histopathological examination , traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori ( HP ) .


Many CNG patients suffer from frequent , recurrent bouts of dyspeptic symptoms .


This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter , parallel-group , double-blind , randomized and placebo-controlled manner .


This trial may not only provide evidence for a phase III clinical trial , but also a vision of an alternative option for CNG treatment .


The registration number , ChiCTR-TRC-14004088 , was assigned by the Chinese Clinical Trial Registry on 7 January 2014 .


To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil as medical expulsive therapy for lower ureteric stones .


Between January 2013 and December 2013 , 244 patients presenting with distal ureteric stones ( size 5-10mm ) were randomized equally to tamsulosin ( group A ) or tamsulosin plus tadalafil ( group B ) .


Therapy was given for a maximum of 4 weeks .


Stone expulsion rate , time to stone expulsion , analgesic use , number of hospital visits for pain , follow up , endoscopic treatment and adverse effects of drugs were recorded .


Statistical analyses were carried out using Student 's t-test and the ( 2 ) - test .


There was a statistically significant higher expulsion rate in group B compared with group A ( 83.6 % vs 65.5 % ; P-value = 0.031 ) and a shorter time to expulsion ( 14.94.4 days vs 16.74.8 days ; P-value = 0.003 ) .


Statistically significant differences were noted in terms of the number of hospital visits and analgesic requirement in favor of group B.


There was no serious adverse event .


An improvement in erectile function was noted in patients of group B compared with those of group A.


Medical expulsive therapy for distal ureteric stones using tamsulosin plus tadalafil is safe , effective and well tolerated .


Furthermore , tadalafil provides the additional advantage of improving erectile dysfunction when this condition coexists with a lower ureteric stone .


This prospective randomized study reports the effect of hyaluronan-enriched embryo transfer media on the outcome of in vitro fertilization and embryo transfer ( IVF-ET ) treatments .


A total of 581 IVF-ET cycles were included in this study .


In the Hyaluronan ( HA ) group ( n = 290 ) , embryos were transferred from hyaluronan-enriched transfer medium .


In Control group ( n = 291 ) , a conventional embryo transfer medium was used .


There was no significant difference in clinical pregnancy rate ( 42.4 vs. 39.2 % ) , implantation rate ( 23.3 vs. 23.2 % ) , and delivery rate ( 31.0 vs. 29.2 % ) between the HA group and the Control group .


The number of newborns was also similar in the two groups ( 111 vs. 110 ) .


However , birth weight was significantly higher in the HA group than in the Control group ( 3,018 598 g vs. 2,724 698 g , P = 0.001 ) .


Clinical pregnancy , implantation and delivery rates did not differ significantly between the HA and the Control group when cycles with advanced maternal age , previous IVF failures , low oocyte number or poor embryo quality were compared .


Our results suggest that hyaluronan enrichment of the embryo transfer media does not seem to have any beneficial effect on IVF outcome .


However , further study is needed to clarify the role of hyaluronan in the implantation process and on the birth weight .


Ipragliflozin is a novel and highly selective sodium-glucose transporter 2 ( SGLT2 ) inhibitor that reduces plasma glucose levels by enhancing urinary glucose excretion in patients with type 2 diabetes mellitus ( T2DM ) .


We examined the pharmacokinetic and pharmacodynamic characteristics of two oral doses of ipragliflozin in Japanese patients with T2DM .


In this randomized , placebo-controlled , double-blind study , patients were treated with placebo , 50mg or 100mg ipragliflozin once daily for 14 days .


Plasma and urine pharmacodynamic parameters were measured on Days -1 and 14 , and pharmacokinetic parameters on Day 14 .


Pharmacodynamic characteristics included area under the curve ( AUC ) for plasma glucose and insulin for 0-3h ( AUC0-3h ) and 0-24h ( AUC0-24h ) .


Pharmacokinetic characteristics included AUC0-24h , maximum ipragliflozin concentration ( Cmax ) , and time to maximum plasma ipragliflozin concentration ( tmax ) .


Thirty patients were enrolled ; 28 were included in pharmacokinetic/pharmacodynamic analyses and 30 in safety analyses .


Administration of 50 and 100mg ipragliflozin significantly reduced fasting plasma glucose , as well as the AUC0-3h and AUC0-24h for plasma glucose relative to placebo .


Both doses of ipragliflozin also reduced AUC0-24h for insulin , body weight , and glycoalbumin , while urinary glucose excretion increased remarkably .


Cmax and AUC0-24h were 1.7 - and 1.9-fold higher , respectively , in the 100-mg group than in the 50-mg group .


Ipragliflozin increased urinary glucose excretion and improved fasting and postprandial glucose , confirming its pharmacokinetic/pharmacodynamic properties in Japanese patients with T2DM .


To observe the outcome after sacral canal injection in patients with disc herniation associated with without sciatica .


From December 2010 to June 2011 , 65 patients with acute low back pain without sciatica due to lumbar disc herniation or bulging confirmed by CT or MRI were randomly divided into sacral canal injection group ( experimental group ) and lumbar oblique wrench group ( control group ) : the experimental group had 35 cases , including 30 males and 5 females , with an average age of ( 43.90 + / - 1.14 ) years old ranging from 33 to 56 years old .


The control group had 30 cases , including 27 males and 3 females , with an average age of ( 44.00 + / - 1.19 ) years old ranging from 34 to 57 years old .


The course of morbidity was 1 to 3 days .


All patients received sacral canal injection or lumbar oblique wrench method .


The visual analog scale ( VAS ) scores before and at 30 min after treatment were compared between two groups .


The symptom of acute low back pain were relieved obviously .


The average VAS scores before and after treatment in experimental group were decreased from 6.63 + / - 0.97 to 3.06 + / - 1.51 , in control group were from 6.67 + / - 0.96 to 3.93 + / - 1.20 respectively .


These two methods could improve the VAS score , but the effect of sacral canal injection group was better than that of lumbar oblique wrench group , there was statistically differences ( P < 0.05 ) .


It is effective that the methods of sacral canal injection and lumbar oblique wrench applied to patients with acute low back pain without sciatica due to lumbar disc herniation or bulging confirmed , the former has better effect .


Weight loss reduces risk factors associated with obesity .


However , long-term metabolic improvement remains a challenge .


We investigated quantitative gene expression of subcutaneous adipose tissue in obese individuals and its relationship with low calorie diet and long term weight maintenance induced changes in insulin resistance .


Three hundred eleven overweight and obese individuals followed a dietary protocol consisting of an 8-week low calorie diet followed by a 6-month ad libitum weight-maintenance diet .


Individuals were clustered according to insulin resistance trajectories assessed using homeostasis model assessment of insulin resistance ( HOMA-IR ) index .


Adipose tissue mRNA levels of 267 genes selected for regulation according to obesity , metabolic status and response to dieting was assessed using high throughput RT-qPCR .


A combination of discriminant analyses was used to identify genes with regulation according to insulin resistance trajectories .


Partial correlation was used to control for change in body mass index .


Three different HOMA-IR profile groups were determined .


HOMA-IR improved during low calorie diet in the 3 groups .


At the end of the 6-month follow-up , groups A and B had reduced HOMA-IR by 50 % .


In group C , HOMA-IR had returned to baseline values .


Genes were differentially expressed in the adipose tissue of individuals according to groups but a single gene , CIDEA , was common to all phases of the dietary intervention .


Changes in adipose tissue CIDEA mRNA levels paralleled variations in insulin sensitivity independently of change in body mass index .


Overall , CIDEA was up-regulated in adipose tissue of individuals with successful long term insulin resistance relapse and not in adipose tissue of unsuccessful individuals .


The concomitant change in adipose tissue CIDEA mRNA levels and insulin sensitivity suggests a beneficial role of adipose tissue CIDEA in long term glucose homeostasis , independently of weight variation .


ClinicalTrials.gov NCT00390637 .


Despite the increasing complexity of medication regimens for persistent cancer pain , little is known about how oncology outpatients and their family caregivers manage pain medications at home .


To describe the day-to-day management of pain medications from the perspectives of oncology outpatients and their family caregivers who participated in a randomized clinical trial of a psychoeducational intervention called the Pro-Self ( ) Plus Pain Control Program .


In this article , we focus on pain medication management in the context of highly individualized home environments and lifestyles .


This qualitative study was conducted as part of a randomized clinical trial , in which an embedded mixed methods research design was used .


Audio-recorded dialogue among patients , family caregivers , and intervention nurses was analyzed using qualitative research methods .


Home and lifestyle contexts for managing pain medications included highly individualized home environments , work and recreational activities , personal routines , and family characteristics .


Pain medication management processes particularly relevant in these contexts included understanding , organizing , storing , scheduling , remembering , and taking the medications .


With the exception of their interactions with the intervention nurses , most study participants had little involvement with clinicians as they worked through these processes .


Pain medication management is an ongoing multidimensional process , each step of which has to be mastered by patients and their family caregivers when cancer treatment and supportive care are provided on an outpatient basis .


Realistic patient - and family-centered skill-building interventions are needed to achieve effective and safe pain medication management in the contexts of individual home environments and lifestyles .


To assess the comparative drug systemic exposure of a reference ( RF ) and four test ( Test I , Test II , Test III and Test IV ) formulations of triclabendazole ( TCBZ ) in heifers .


Thirty Holstein heifers were randomly distributed into five groups ( n = 6 per group ) .


Animals in the RF group received the reference formulation ( Fasinex ) , and those in the other groups received different commercially available TCBZ formulations ( Test I , Test II , Test III and Test IV ) .


All treatments were orally administered at 12 mg/kg bodyweight .


The concentrations of TCBZ metabolites in plasma between 0 and 168 hours after treatment were quantified by high-performance liquid chromatography ( HPLC ) .


Triclabendazole sulphoxide ( TCBZ.SO ) and TCBZ-sulphone ( TCBZ.SO ) were the only analytes recovered in plasma .


Only the Test I formulation did not differ from the RF for all pharmacokinetic parameters measured for either metabolite ( p > 0.8 ) .


The TCBZ.SO area under the concentration vs. time curve for Test II formulation ( 268.9 g.h / mL ) was lower , and for Test III ( 619.9 g.h / mL ) and Test IV ( 683.4 g.h / mL ) was higher , than the RF ( 418.1 g.h / mL ) ( p < 0.005 ) .


Based on the currently available bioequivalence criteria , the only test formulation under evaluation that could be considered equivalent to the RF was the Test I formulation , which demonstrated an equivalent systemic exposure for the active TCBZ.SO metabolite .


This comparison of TCBZ pioneer and test formulations in cattle raises awareness of the need for further quality control for drug approval in the veterinary pharmaceutical field in many regions of the world .


The purpose of this pilot study was to conduct limited-efficacy testing of the newly developed Preserving Identity and Planning for Advance Care ( PIPAC ) intervention on self-reported and proxy-reported emotional and health-related outcomes of individuals in the early stages of dementia .


A two-group comparison design was implemented .


Blocked randomization was used to assign individuals with mild dementia and a family contact to either ( 1 ) the four-session , multi-component intervention group focused on reminiscence and future planning or ( 2 ) the minimal support phone contact comparison group .


Of the 19 enrolled dyads , 18completed post-treatment assessments ( i.e. 10 intervention and 8 comparison group ) .


Individuals with dementia were M = 82.8 ( SD = 6.46 ) years old ; 31.6 % were men and 68.4 % were women .


Participants were predominantly white/Caucasian ( n = 18 , 94.7 % ) with one black/African-American ( 5.3 % ) .


Analyses of covariance controlling for baseline differences revealed clinically meaningful differences ( with medium to large effect sizes ) between groups at post-treatment for depressive symptoms , quality of life , health-related quality of life indicators , and decisional conflict .


Individuals in the intervention group were also observed to exhibit higher levels of coping .


Feasibility data collected from participants and interventionists were encouraging .


Emotion-focused , patient-centered interventions like PIPAC hold promise for advancing treatment options in the early and mild stages of dementia .


A full-scale , randomized clinical trial of this intervention is warranted to determine both short-term and long-term impacts on clinical outcomes including improved depressive symptomatology , quality of life , and health-related factors that impact daily functioning in social environments .


Currently , there are no published data on pharmacokinetics ( PK ) of everolimus in combination with cyclosporine in Japanese renal transplant patients .


We evaluated the PK of everolimus in Japanese de novo renal transplant patients who received everolimus in combination with cyclosporine .


In this phase 3 , multicenter , randomized , open-label study , patients were randomized ( 1:1 ) to 1 of the 2 groups : everolimus 1.5 mg ( targeted C0 of 3-8 ng/mL ) plus reduced-dose cyclosporine or mycophenolate mofetil 2 g/d plus standard-dose cyclosporine .


PK assessments for everolimus were performed on day 28 ( month 1 ) in the PK subpopulation .


A total of 11 patients ( 7 men ) , mean age 47.5 11.21 years , were enrolled for PK analysis of everolimus .


Starting at 1.5 mg ( 0.75 mg twice a day ) , the mean dose over a period of 28 days was 0.705 0.1011 mg .


Everolimus mean trough concentration was 4.307 1.2459 ng/mL and mean peak concentration was 13.539 3.5330 ng/mL , which peaked at 1 to 2 hours postdose .


The average concentration was 7.558 1.4723 ng/mL , area under the concentration-time curve was 90.70 17.667 ngh/mL , and peak-trough fluctuation was 122.6 % .


The PK parameters of everolimus were comparable to those in the earlier phase 3 studies ( A2306 and A2307 ) .


The mean everolimus trough levels were within the target ranges at all time points ranging from 3.4 to 5.5 ng/mL ( everolimus 0.75 mg twice a day , safety population ) .


The majority of patients ( > 85 % from day 7 onward ) were maintained within the targeted everolimus trough blood levels ( safety population ) .


These data were similar to a non-Japanese study ( A2309 ) .


The pharmacokinetic characteristics of everolimus in Japanese de novo renal transplant patients did not differ from those previously observed in non-Japanese patients , hence the same dosage of everolimus may be acceptable in Japanese patients .


Nerve growth factor ( NGF ) induces profound hyperalgesia .


In this study we explored patterns of NGF sensitization in muscle and fascia of distal and paraspinal sites .


We injected 1 g of NGF into human ( n = 8 ) tibialis anterior and erector spinae muscles and their fasciae .


The spatial extent of pressure sensitization , pressure pain threshold , and mechanical hyperalgesia ( 150 kPa , 10 s ) was assessed at days 0.25 , 1 , 3 , 7 , 14 , and 21 .


Chemical sensitization was explored by acidic buffer injections ( pH 4 , 100 l ) at days 7 and 14 .


The mechanical hyperalgesia area was larger in tibial fascia than in muscle .


Pressure pain thresholds were lower , tonic pressure pain ratings , and citrate buffer evoked pain higher in fascia than in muscle .


Spatial mechanical sensitization differs between muscle and fascia .


Thoracolumbar fasciae appear more sensitive than tibial fasciae and may be major contributors to low back pain , but the temporal sensitization profile is similar between paraspinal and distal sites .


Muscle Nerve 52 : 265-272 , 2015 .


Pegylated interferon ( peginterferon ) alfa 2a or 2b plus ribavirin regimens were the standard of care in patients with hepatitis C virus ( HCV ) infection , but the sustained virological response can be suboptimum in patients with HCV genotype 1 infection .


The efficacy , safety , and tolerability of the combination of simeprevir , a one-pill , once-daily , oral HCV NS3/4A protease inhibitor versus placebo , plus peginterferon alfa 2a or 2b plus ribavirin was assessed in treatment-naive patients with HCV genotype 1 infection .


In the QUEST-2 , phase 3 study , done at 76 sites in 14 countries ( Europe , and North and South Americas ) , patients with confirmed chronic HCV genotype 1 infection and no history of HCV treatment were randomly assigned with a computer-generated allocation sequence in a ratio of 2:1 and stratified by HCV genotype 1 subtype and host IL28B genotype to receive simeprevir ( 150 mg once daily , orally ) , peginterferon alfa 2a ( 180 g once weekly , subcutaneous injection ) or 2b ( according to bodyweight ; 50 g , 80 g , 100 g , 120 g , or 150 g once weekly , subcutaneous injection ) , plus ribavirin ( 1000-1200 mg/day or 800-1400 mg/day , orally ; simeprevir group ) or placebo ( once daily , orally ) , peginterferon alfa 2a or 2b , plus ribavirin ( placebo group ) for 12 weeks , followed by just peginterferon alfa 2a or 2b plus ribavirin .


Total treatment duration was 24 weeks or 48 weeks ( simeprevir group ) based on criteria for response-guided therapy ( ie , HCV RNA < 25 IU/mL undetectable or detectable at week 4 and undetectable week 12 ) or 48 weeks ( placebo ) .


Patients , study personnel , and the sponsor were masked to treatment assignment .


The primary efficacy endpoint was sustained virological response at 12 weeks after the planned end of treatment ( SVR12 ) .


Analyses were by intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT01290679 .


Results from the primary ( SVR12 , week 60 ) analysis are presented .


209 ( 81 % ) of 257 patients in the simeprevir group and 67 ( 50 % ) of 134 in the placebo group had SVR12 ( adjusted difference 322 % , 95 % CI 233-412 ; p < 00001 ) .


The incidences of adverse events were similar in the simeprevir and placebo groups at 12 weeks ( 246 [ 96 % ] vs 130 [ 97 % ] ) and for the entire treatment ( 249 [ 97 % ] vs 132 [ 99 % ] ) , irrespective of the peginterferon alfa used .


The most common adverse events were headache , fatigue , pyrexia , and influenza-like illness at 12 weeks ( 95 [ 37 % ) vs 45 [ 34 % ] , 89 [ 35 % ] vs 52 [ 39 % ] , 78 [ 30 % ] vs 48 [ 36 % ] , and 66 [ 26 % ] vs 34 [ 25 % ] , respectively ) and for the entire treatment ( 100 [ 39 % ] vs 49 [ 37 % ] , 94 [ 37 % ] vs 56 [ 42 % ] , 79 [ 31 % ] vs 53 [ 40 % ] , and 66 [ 26 % ] vs 35 [ 26 % ] , respectively ) .


Rash and photosensitivity frequencies were higher in the simeprevir group than in the placebo group ( 61 [ 24 % ] vs 15 [ 11 % ] and ten [ 4 % ] vs one [ < 1 % ] , respectively ) .


There was no difference in the prevalence of anaemia between the simeprevir and placebo groups ( 35 [ 14 % ] vs 21 [ 16 % ] , respectively , at 12 weeks , and 53 [ 21 % ] vs 37 [ 28 % ] , respectively , during the entire treatment ) .


Addition of simeprevir to either peginterferon alfa 2a or peginterferon alfa 2b plus ribavirin improved SVR in treatment-naive patients with HCV genotype 1 infection , without worsening the known adverse events associated with peginterferon alfa plus ribavirin .


Janssen Infectious Diseases-Diagnostics .


Bread can contribute to the regulation of appetite .


The objective of this study was to investigate the appetite ratings and postprandial glucose , insulin , and gastrointestinal hormone responses related to hunger and satiety after the intake of a cereal-based bread .


A randomized , controlled crossover trial was conducted in 30 healthy adults ( 17 men and 13 women ) aged 19-32 y with body mass index of 19.2-28 .5 .


Each volunteer consumed the cereal-based bread and the control bread 2 times , with a 1-wk wash-out period , over a total of 4 sessions .


The cereal-based bread contained a variety of cereal flours ( wheat , oat , and spelt ) and consisted of 22 % dried fruits ( figs , apricots , raisins , and prunes ) .


It was also enriched with both fiber ( 7 % from wheat cross-linked maltodextrins and pea ) and protein ( 10-11 % from wheat gluten and hydrolyzed wheat proteins ) .


The control bread consisted of white bread with margarine and jam to control for energy density , fat , and sugar content .


We measured appetite ratings using standardized visual analogue scales and glucose , insulin , and gastrointestinal hormone responses over a postprandial time of 4 h after the ingestion of each bread .


Linear mixed-effects models were used to compare the areas under the curve ( AUCs ) for different variables .


Consuming the cereal-based bread decreased prospective consumption more than consumption of the control bread ( -5.3 0.6 m min and -4.4 0.6 m min , respectively ; P = 0.02 ) and increased satiety more ( 6.2 0.7 m min and 5.2 0.6 m min , respectively ; P = 0.04 ) , although subsequent ad libitum energy intake 4 h later did not differ .


Postprandial blood glucose , insulin , ghrelin , glucagon-like peptide 1 and gastric inhibitory polypeptide AUCs were lower after the ingestion of the cereal-based bread , whereas the pancreatic polypeptide AUC was higher than with the control bread ( P < 0.05 ) .


Consumption of the cereal-based bread contributed to appetite control by reducing hunger and enhancing satiety .


In addition , consumption of this bread improved glycemic , insulinemic , and gastrointestinal hormone responses in healthy adults .


This trial was registered at clinicaltrials.gov as NCT02090049 .


The purpose was to assess the effectiveness of 5 % oral glucose solution in reducing pain in preterm infants during intramuscular injection .


We conducted a prospective , randomized , controlled , unblinded trial to investigate the effect of glucose solution on the pain of intramuscular injection in preterm infants ( N = 80 ) .


Infants who received oral glucose had significantly lower pain scores ( p < .001 ) , less crying time ( p < .001 ) , higher oxygen saturation ( p < .001 ) , and lower heart rate after compared with during the procedure ( p = .02 ) .


Our results suggest that oral glucose , even if used in the lowest dose , may have a pain-relieving effect in preterm infants if administered pre-procedure .


There are limited data about the effects of sodium-glucose cotransporter 2 inhibitors when used with insulin .


We report the efficacy and safety of canagliflozin in patients with type 2 diabetes using insulin .


The CANagliflozin CardioVascular Assessment Study is a double-blind , placebo-controlled study that randomized participants to placebo , canagliflozin 100 mg , or canagliflozin 300 mg once daily , added to a range of therapies .


The primary end point of this substudy was the change in HbA1c from baseline at 18 weeks among patients using insulin ; 52-week effects were also examined .


Individuals receiving insulin at baseline were randomized to receive placebo ( n = 690 ) , canagliflozin 100 mg ( n = 692 ) , or canagliflozin 300 mg ( n = 690 ) .


These individuals were 66 % male and had a median age of 63 years , mean HbA1c of 8.3 % ( 67 mmol/mol ) , BMI of 33.1 kg/m ( 2 ) , estimated glomerular filtration rate of 75 mL/min/1 .73 m ( 2 ) , fasting plasma glucose of 9.2 mmol/L , and a median daily insulin dose of 60 IU .


Most individuals were using basal/bolus insulin .


Reductions in HbA1c with canagliflozin 100 and 300 mg versus placebo were -0.62 % ( 95 % CI -0.69 , -0.54 ; -6.8 mmol/mol [ 95 % CI -7.5 , -5.9 ] ; P < 0.001 ) and -0.73 % ( 95 % CI -0.81 , -0.65 ; -8.0 mmol/mol [ 95 % CI -8.9 , -7.1 ] ; P < 0.001 ) at 18 weeks and -0.58 % ( 95 % CI -0.68 , -0.48 ; -6.3 mmol/mol [ 95 % CI -7.4 , -5.2 ] ) and -0.73 % ( 95 % CI -0.83 , -0.63 ; -8.0 mmol/mol [ 95 % CI -9.1 , -6.9 ] ) at 52 weeks .


There were significant falls in fasting plasma glucose , body weight , and blood pressure at both time points and there was a greater incidence of hypoglycemia , genital mycotic infections , and hypovolemia with both canagliflozin doses .


Canagliflozin added to insulin therapy improved glycemic control and decreased body weight .


There was a greater frequency of several anticipated side effects , although few led to discontinuation of treatment .


To assess the short-term efficacy of a video-based cognitive behavioral therapy for insomnia ( CBT-I ) as compared to a professionally administered CBT-I and to a no-treatment group .


Randomized controlled trial .


Radio-oncology department of a public hospital affiliated with Universit Laval ( CHU de Qubec ) .


Two hundred forty-two women with breast cancer who had received radiation therapy in the past 18 mo and who had insomnia symptoms or were using hypnotic medications were randomized to : ( 1 ) professionally administered CBT-I ( PCBT-I ; n = 81 ) ; ( 2 ) video-based CBT-I ( VCBT-I ; n = 80 ) ; and ( 3 ) no treatment ( CTL ; n = 81 ) .


PCBT-I composed of six weekly , individual sessions of approximately 50 min ; VCBT-I composed of a 60-min animated video + six booklets .


Insomnia Severity Index ( ISI ) total score and sleep parameters derived from a daily sleep diary and actigraphy , collected at pretreatment and posttreatment .


PCBT-I and VCBT-I were associated with significantly greater sleep improvements , assessed subjectively , as compared to CTL .


However , relative to VCBT-I , PCBT-I was associated with significantly greater improvements of insomnia severity , early morning awakenings , depression , fatigue , and dysfunctional beliefs about sleep .


The remission rates of insomnia ( ISI < 8 ) were significantly greater in PCBT-I as compared to VCBT-I ( 71.3 % versus 44.3 % , P < 0.005 ) .


A self-administered cognitive behavioral therapy for insomnia ( CBT-I ) using a video format appears to be a valuable treatment option , but face-to-face sessions remain the optimal format for administering CBT-I efficaciously in patients with breast cancer .


Self-help interventions for insomnia may constitute an appropriate entry level as part of a stepped care model .


ClinicalTrials.gov Identifier : NCT00674830 .


Savard J , Ivers H , Savard MH , Morin CM .


Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer ?


Results of a randomized controlled trial .


To explore the experience of breast cancer patients who either received acupuncture or were allocated to the control group .


Focus group/interviews nested within our multi-site randomised controlled trial .


Participants were recruited from the standard care and experimental arm .


The interviews/focus groups were transcribed and analysed thematically .


Of the 302 eligible participants 13 % ( n = 40 ) contributed to the focus groups/interviews , across three study sites in the UK .


Five common themes were identified , including : drivers to take part , the experience of receiving acupuncture , being allocated standard care ( control ) and reflections on taking part in the trial .


The subgroup of control group participants ( n = 9 ) reported disappointment on hearing their allocation , but recognised the value of their role to the study .


Recipients of acupuncture reported beneficial effects in managing fatigue and related symptoms .


The finding that control participants were disappointed warrants further investigation and consideration when designing interventional studies .


The aim of this study was to explore the impact of dynamic contrast-enhanced ( DCE ) computer tomography ( CT ) as a biomarker in metastatic renal cell carcinoma ( mRCC ) .


Twelve patients with favorable or intermediate Memorial Sloan Kettering Cancer Center risk group and clear cell mRCC participating in an ongoing prospective randomized phase II trial comprising interleukin-2-based immunotherapy and bevacizumab were included in this preliminary analysis .


All patients had a follow-up time of at least 2 years .


Interpretation of DCE-CT ( max slope method ) was performed blinded to treatment group .


The DCE-CT scans were performed at baseline , at weeks 5 and 10 , and thereafter every third month .


Blood flow ( BF ; mL/min/100 mL ) , peak enhancement ( Hounsfield units ) , time to peak ( seconds ) , and blood volume ( BV ; mL/100 g ) were calculated .


Parameters for DCE-CT were correlated with sum of diameters ( defined by Response Evaluation Criteria in Solid Tumors 1.1 ) , progression-free survival ( PFS ) , and overall survival ( OS ) using Wilcoxon , Man-Whitney , Kaplan-Meier , and log rank statistics , as appropriate .


Blood flow at baseline ranged from 4.9 to 148.1 mL/min/100 mL ( median , 62.2 ; 25th percentile , 25.8 ; 75th percentile , 110.0 ) .


Patients with high baseline BF ( using quartiles as cutoffs ) had significantly longer OS ( not reached vs 5.2 months , P = 0.011 ) and longer PFS ( not reached vs 3.9 months , P = 0.026 ) .


Blood volume at baseline ranged from 8.8 to 74.1 mL/100 g tissue ( median , 21.5 ) , and at week 5 , from 4.9 to 34.7 mL/100 g ( median , 17.2 ) .


Relative changes in BV between baseline and week 5 ranged from -64 % to +68 % ( median , -16 % ; 25th percentile , -41 % ; 75th percentile , +2 % ) and were significantly associated with OS using quartiles as cutoffs ( 5.2 months vs not reached , P = 0.038 ) and PFS using the median as cutoff ( 5.3 months vs not reached , P = 0.009 ) , with larger reductions associated with longer survival .


Using medians as cutoffs , relative changes in both BF and BV between baseline and week 10 were significantly associated with OS ( for both , 8.6 months vs not reached , P = 0.031 ) .


Dynamic contrast-enhanced CT is a potential biomarker in patients with mRCC .


High baseline BF and reductions in BF and BV during early treatment are associated with improved outcome .


Large-scale studies are required .


The aims of this study were to ( i ) evaluate the efficacy of phoneme discrimination training for hearing and cognitive abilities of adults aged 50 to 74 years with mild sensorineural hearing loss who were not users of hearing aids , and to ( ii ) determine participant compliance with a self-administered , computer-delivered , home - and game-based auditory training program .


This study was a randomized controlled trial with repeated measures and crossover design .


Participants were trained and tested over an 8 - to 12-week period .


One group ( Immediate Training ) trained during weeks 1 and 4 .


A second waitlist group ( Delayed Training ) did no training during weeks 1 and 4 , but then trained during weeks 5 and 8 .


On-task ( phoneme discrimination ) and transferable outcome measures ( speech perception , cognition , self-report of hearing disability ) for both groups were obtained during weeks 0 , 4 , and 8 , and for the Delayed Training group only at week 12 .


Robust phoneme discrimination learning was found for both groups , with the largest improvements in threshold shown for those with the poorest initial thresholds .


Between weeks 1 and 4 , the Immediate Training group showed moderate , significant improvements on self-report of hearing disability , divided attention , and working memory , specifically for conditions or situations that were more complex and therefore more challenging .


Training did not result in consistent improvements in speech perception in noise .


There was no evidence of any test-retest effects between weeks 1 and 4 for the Delayed Training group .


Retention of benefit at 4 weeks post-training was shown for phoneme discrimination , divided attention , working memory , and self-report of hearing disability .


Improved divided attention and reduced self-reported hearing difficulties were highly correlated .


It was observed that phoneme discrimination training benefits some but not all people with mild hearing loss .


Evidence presented here , together with that of other studies that used different training stimuli , suggests that auditory training may facilitate cognitive skills that index executive function and the self-perception of hearing difficulty in challenging situations .


The development of cognitive skills may be more important than the development of sensory skills for improving communication and speech perception in everyday life .


However , improvements were modest .


Outcome measures need to be appropriately challenging to be sensitive to the effects of the relatively small amount of training performed .


Expiratory asynchrony during pressure support ventilation ( PSV ) has been recognized as a cause of patient discomfort , increased workload , and impaired weaning process .


We evaluated breathing pattern , patient comfort , and patient effort during PSV comparing 2 flow termination criteria : fixed at 5 % of peak inspiratory flow vs automatic , real-time , breath-by-breath adjustment within the range of 5 % to 55 % .


Randomized crossover clinical trial .


Sixteen awake patients , in the process of weaning , under PSV for more than 24 hours were subjected to 3 phases of PSV , each lasting 1 hour and using 1 of the 2 aforementioned termination criteria .


Effective pressure support during automatic adjustment ( AA ) was 12.53.2 cm H2O vs 12.53.9 cm H2O ( P = .9 ) with the fixed termination criterion , and external positive end-expiratory pressure was 6.21.8 vs 6.82 ( P < .05 ) .


The effective termination criterion was higher during AA ( 31 % [ 23-39 ] vs 12 % [ 6-23 ] ; P < .01 ) , but without producing premature breath terminations .


Pressure overshoots and alternative cycling-off were also decreased .


Throughout the AA period , we observed a higher respiratory rate ( 248 breaths/min vs 196 breaths/min ; P < .001 ) , lower tidal volume ( 484 88 mL vs 518102 mL ; P < .001 ) , and shorter inspiratory times ( 1.00.3 seconds vs 1.30.3 seconds ; P < .001 ) .


Automatic adjustment was associated with lower airway occlusion pressure after 0.1 second ( P0 .1 ) ( 1.80.9 cm H2O vs 2.41 cm H2O ; P < .01 ) , lower pressure-time product to trigger the ventilator , and lower subjective discomfort ( visual analog scale , 3.71.3 vs 4.51.2 ; P < .001 ) .


When compared with a fixed termination criterion , the use of a variable , real-time-adjusted termination criterion improved some indices of patient-ventilator synchrony , producing better breathing pattern , less discomfort , and slightly lower patient effort during PSV .


Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment ( MCI ) .


The MEMO + study is a randomized , controlled , single-blind trial designed to test the efficacy , specificity , and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI .


One hundred and sixty-two participants with MCI will be recruited .


They will be randomized into three groups : cognitive training , psychosocial intervention , and no-contact .


Each intervention will last for eight weeks ( one session per week ) and a booster training session will be provided three months after the end of the intervention .


Various proximal and distal outcomes will be measured at pre-intervention as well as at one week , three months , and six months post-training .


Proximal outcomes include memory and psychological health measures .


Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function .


Socio-demographic factors ( age , gender , and education ) , general cognition , personality traits , engagement in activities , and self-efficacy will be used as moderators .


Enrolment began in April 2012 and will be completed by December 2014 .


This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions .


To identify risk factors for early study termination and motivators for adherence to a long-term followup trial and to improve completeness of long-term studies .


Risk factors for early termination in 508 included patients were identified through Cox regression analysis .


Patients completing the 10-year followup filled in a questionnaire on possible motives for continued study participation .


Risk factors for early termination were higher age ( hazard ratio [ HR ] 1.03 , 95 % confidence interval [ 95 % CI ] 1.02-1 .04 ) , functional disability during the preceding year ( HR 1.54 , 95 % CI 1.20-1 .99 ) , having achieved drug-free remission ( HR 6.62 , 95 % CI 2.07-21 .14 ) , limited joint damage ( HR 0.98 , 95 % CI 0.97-0 .995 for actual damage ; HR 0.83 , 95 % CI 0.73-0 .94 for damage progression ) , and few adverse events ( HR 0.35 , 95 % CI 0.26-0 .47 ) .