Local anesthesia ( 1 mL of ketamine plus 2 mL of bupivacaine 0.5 % or 1 mL of normal saline plus 2 mL of bupivacaine 0.5 % ) combined with spinal anesthesia reduces postoperative pain and leads to greater comfort in recovering patients .


This study investigated inter-rater agreement ( IRA ) among EEG experts for the identification of electrographic seizures and periodic discharges ( PDs ) in continuous ICU EEG recordings .


Eight board-certified EEG experts independently identified seizures and PDs in thirty 1-h EEG segments which were selected from ICU EEG recordings collected from three medical centers .


IRA was compared between seizure and PD identifications , as well as among rater groups that have passed an ICU EEG Certification Test , developed by the Critical Care EEG Monitoring Research Consortium ( CCEMRC ) .


Both kappa and event-based IRA statistics showed higher mean values in identification of seizures compared to PDs ( k = 0.58 vs. 0.38 ; p < 0.001 ) .


The group of rater pairs who had both passed the ICU EEG Certification Test had a significantly higher mean IRA in comparison to rater pairs in which neither had passed the test .


IRA among experts is significantly higher for identification of electrographic seizures compared to PDs .


Additional instruction , such as the training module and certification test developed by the CCEMRC , could enhance this IRA .


This study demonstrates more disagreement in the labeling of PDs in comparison to seizures .


This may be improved by education about standard EEG nomenclature .


The aim of this study was to comparatively evaluate three different stabilization methods with regards to the amount of shrinkage in free gingival graft .


Forty-five patients were included in three study groups : where stabilization was achieved with conventional technique , cyanoacrylate or microsurgery .


In the conventional group standardized 5-0 sutures were used .


In the microsurgery group grafts were stabilized with 7-0 sutures and loupe .


In the third group , graft was stabilized with cyanoacrylate .


Keratinized tissue width , graft area , gingival recession were calculated by a specific software on standard photographs at baseline , 1 - , 3 - , 6-month follow-ups .


Duration of surgery was also recorded .


Pain in recipient and donor sites was assessed using visual analogue scale within the first postoperative week .


Change in keratinized tissue width was similar in the study groups at all times .


Graft shrinkage was significantly less ( p < 0.05 ) in the cyanoacrylate group than the other groups , whereas those in the conventional and microsurgery groups were similar .


Significantly less pain in the recipient site was reported by the patients in the cyanoacrylate group ( p < 0.05 ) .


Duration of surgery was significantly less in the cyanoacrylate group than the other groups ( p < 0.05 ) .


Less graft shrinkage in the free gingival graft , together with shorter surgery time and less pain in the recipient site obtained in the cyanoacrylate group , suggest that cyanoacrylate may be considered as an alternative for stabilization of free gingival grafts .


ECAR ( Endovasculaire ou Chirurgie dans les Anvrysmes aorto-iliaques Rompus ) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms ( rAIA ) eligible for treatment by either endovascular ( EVAR ) or open surgical repair ( OSR ) .


Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture .


Randomization was done by week , synchronously in all centers .


The primary end point was 30 day mortality .


Secondary end points were post-operative morbidity , length of stay in the intensive care unit ( ICU ) , amount of blood transfused ( units ) and 6 month mortality .


From January 2008 to January 2013 , 107 patients ( 97 men , 10 women ; median age 74.4 years ) were enrolled in 14 centers : 56 ( 52.3 % ) in the EVAR group and 51 ( 47.7 % ) in the OSR group .


The groups were similar in terms of age , sex , consciousness , systolic blood pressure , Hardman index , IGSII score , type of rupture , use of endoclamping balloon , and levels of troponin , creatinine , and hemoglobin .


Delay to treatment was higher in the EVAR group ( 2.9 vs. 1.3 hours ; p < .005 ) .


Mortality at 30 days and 1 year were not different between the groups ( 18 % in the EVAR group vs. 24 % in the OSR group at 30 days , and 30 % vs. 35 % , respectively , at 1 year ) .


Total respiratory support time was lower in the EVAR group than in the OSR group ( 59.3 hours vs. 180.3 hours ; p = .007 ) , as were pulmonary complications ( 15.4 % vs. 41.5 % , respectively ; p = .050 ) , total blood transfusion ( 6.8 vs. 10.9 , respectively ; p = .020 ) , and duration of ICU stay ( 7 days vs. 11.9 days , respectively ; p = .010 ) .


In this study , EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality .


However , EVAR was associated with less severe complications and less consumption of hospital resources than OSR .


Interferon ( IFN ) - therapy for chronic hepatitis C virus infection is frequently associated with depression .


The routine prophylaxis with antidepressants might expose patients to adverse effects , hence , the need for alternative preventive interventions .


Omega-3 polyunsaturated fatty acids are safe and effective essential nutritional compounds used for the treatment of depression , putatively through an anti-inflammatory action .


In addition , lower erythrocyte levels of omega-3 polyunsaturated fatty acids have been associated with an increased risk of IFN-induced depression .


We conducted a 2-week , double-blind , placebo-controlled trial comparing eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and placebo for the prevention of IFN -- induced depression .


A total of 162 patients consented to participate and were randomized to the study .


All of the patients completed the 2-week trial ; 152 participants were followed throughout the 24 weeks of IFN - treatment and were included in the analysis .


Compared with placebo , the incident rates of IFN -- induced depression were significantly lower in EPA-treated but not in DHA-treated patients ( 10 % and 28 % , respectively , versus 30 % for placebo , p = .037 ) .


Both EPA and DHA significantly delayed the onset of IFN-induced depression ( week of onset : 12.0 and 11.7 , respectively , versus 5.3 for placebo , p = .002 ) .


EPA and DHA were both well tolerated in this population .


EPA treatment increased both EPA and DHA erythrocyte levels , but DHA only increased DHA erythrocyte levels .


EPA is effective in the prevention of depression in hepatitis C virus patients received IFN - therapy .


Our study confirms the notion that anti-inflammatory strategies are effective antidepressants in the context of depression associated with inflammation .


Some children have residual amblyopia after treatment with atropine eyedrops for amblyopia due to strabismus and/or anisometropia .


We conducted a randomized clinical trial to evaluate the effectiveness of augmenting the effect of atropine by changing the lens over the fellow eye to plano in children with residual amblyopia .


A total of 73 children 3 to < 8 years of age ( mean , 5.8 years ) with stable residual amblyopia ( range , 20/32 to 20/160 , mean 20/63 ( +1 ) ) were enrolled after at least 12 weeks of atropine treatment of the fellow eye .


Participants were randomly assigned to continuing weekend atropine alone or wearing a plano lens over the fellow eye ( while continuing atropine ) .


The primary outcome was assessed at 10 weeks , and participants were followed until improvement ceased .


At the 10-week primary outcome visit , amblyopic-eye visual acuity had improved an average of 1.1 lines with the plano lens and 0.6 lines with atropine only ( difference adjusted for baseline visual acuity = + 0.5 line ; 95 % CI , -0.1 to +1.2 ) .


At the primary outcome or later visit when the best-measured visual acuity was observed , the mean amblyopic-eye improvement from baseline was 1.9 lines with the plano lens and 0.8 lines with atropine only .


When amblyopic-eye visual acuity stops improving with atropine treatment , there may be a small benefit to augmenting atropine therapy with a plano lens over the fellow eye .


However , the effect was not statistically significant , and the large confidence interval raises the possibility of no benefit or a benefit larger than we observed .


A larger study would be necessary to get a more precise estimate of the treatment effect .


To assess the efficacy and safety of heated humidified high-flow nasal cannula ( HHHFNC ) ventilation compared with nasal continuous positive airway pressure ( NCPAP ) on prevention of extubation failure in the NICUs .


A prospective randomized , controlled un-blinded study was conducted in 12 tertiary hospitals in Hebei Province from December 1 , 2012 to May 31 , 2013 .


Neonates were eligible for this study if they were admitted to the participating NICUs within 7 days of postnatal age , and needed noninvasive respiratory support after a period of mechanical ventilation with an endotracheal tube .


Infants were randomly assigned to either HHHFNC or NCPAP group .


The primary outcome measures included : the incidence of extubation failure , bronchopulmonary dysplasia and the mortality before discharge .


Among the 255 cases included , 128 were in the HHHFNC group , and 127 were in the NCPAP group .


There was no significant difference in gestational age , birth weight , and age at randomization , and male/female ratio between the two groups ( P > 0.05 ) .


There were no significant differences between groups for days on ventilation , noninvasive respiratory support , oxygen requirement , hospital stay and time to full oral feedings ( P > 0.05 ) .


The overall mortality of the studied population was 10.6 % ( 27/255 ) .


The occurrence of extubation failure within 7 days was 9.4 % whereas 29.0 % in very low birth weight infants .


There was no significant difference in the extubation failure for HHHFNC ( 12/128 , 9.4 % ) versus NCPAP ( 12/127 , 9.4 % ) ( P > 0.05 ) , or in mortality for HHHFNC ( 12/128 , 9.4 % ) versus NCPAP ( 15/127 , 11.8 % ) ( P > 0.05 ) .


No significant difference was found between the study groups in the occurrence of bronchopulmonary dysplasia ( BPD ) and most of severe adverse outcomes analyzed , including air leak syndrome and nasal trauma .


The occurrence of abdominal distention during treatment was higher in NCPAP than HHHFNC group ( 12.6 % vs. 5.5 % , P < 0.05 ) .


Among infants 7 d of postnatal age , HHHFNC appears to have efficacy and safety similar to those of NCPAP group when applied immediately post-extubation to prevent extubation failure .


Despite concerns on unmonitored pressure delivery during HHHFNC support , no increase of the occurrence of BPD , air leak syndrome or mortality was found .


Randomized trials found that use of erythropoiesis-stimulating agents to target normal hematocrit ( Hct ) levels ( > 39 % ) compared with 27 % -34.5 % increases cardiovascular risk and mortality among chronic kidney disease patients .


However , the effects of the most widely used Hct target in the past 2 decades , 34.5 % -39 % , have never been examined .


To compare the effects of 2 Hct target strategies-30 .0 % -34.5 % ( low ) and 34.5 % -39.0 % ( mid ) in a high-risk population : elderly dialysis patients with significant comorbidities .


Observational data from the US Renal Data System were used to emulate a randomized trial in which patients were assigned to either Hct strategy .


Follow-up started after completing 3 months of hemodialysis and ended 6 months later .


We conducted the observational analogs of intention-to-treat and per-protocol analyses .


Inverse-probability weighting was used to adjust for measured time-dependent confounding by indication .


A total of 22,474 elderly patients with both diabetes and cardiovascular disease who initiated hemodialysis in 2006-2008 .


Hazard ratios ( HRs ) and survival probabilities for all-cause mortality and a composite cardiovascular and mortality endpoint .


The intention-to-treat HR ( 95 % confidence interval ) for mid versus low Hct strategy was 1.05 ( 0.99-1 .11 ) for all-cause mortality and 1.03 ( 0.98-1 .08 ) for the composite endpoint .


The per-protocol HR ( 95 % confidence interval ) for mid versus low Hct strategy was 0.98 ( 0.78-1 .24 ) for all-cause mortality and 1.00 ( 0.81-1 .24 ) for the composite outcome .


Among hemodialysis patients , we did not find differences in 6-month survival or cardiovascular risk between clinical strategies that target Hct at 30.0 % -34.5 % versus 34.5 % -39.0 % .


Few cancers pose greater challenges than head and neck ( H&N ) cancer .


Residual effects following treatment include body image changes , pain , fatigue and difficulties with appetite , swallowing and speech .


Depression is a common comorbidity .


There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment .


In this study , we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer .


This is a preliminary study in which 120 patients will be recruited .


A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan ( HNCP ) involving pre - and post-intervention assessments will be used .


Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms : ( 1 ) usual care , ( 2 ) information in the form of a written resource or ( 3 ) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support .


The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP , based on principles of chronic disease self-management .


Participants will be assessed at baseline , 3 and 6 months .


The primary outcome measure is quality of life .


The secondary outcome measures include mood , self-efficacy and health-care utilisation .


The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses , managers and administrators .


Interviews with patients who received the HNCP will explore their perceptions of the HNCP , including factors that assisted them in achieving behavioural change .


In this study , we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment .


Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and , if successful , will be a model of care that can be implemented for diverse patient populations .


ACTRN12613000542796 ( registered on 15 May 2013 ) .


Antiviral therapy with interferon-alpha ( IFN - ) for hepatitis C virus ( HCV ) infection is associated with increased risk for depression .


To identify clinical predictors for IFN -- induced depression during antiviral therapy for HCV infection .


Depression ( defined with the Montgomery-sberg Depression Rating Scale ( MADRS ) ) was evaluated before and during antiviral treatment in 91 people with chronic HCV infection without a history of psychiatric disorders .


Cognitive function was evaluated using the Trail Making Test A/B ( TMT A/B ) .


( Trial registration at ClinicalTrials.gov : NCT00136318 . )


Depression during antiviral therapy was significantly associated with a baseline MADRS score of 3 or higher ( P = 0.006 ) .


In total , 89 % ( n = 16 ) of patients who had a baseline score > 0 for the single item sadness developed depression .


Poor baseline performance in the TMT A ( P = 0.027 ) and TMT B ( P = 0.033 ) was predictive for severe depression .


Pre-treatment screening for subthreshold depressive and cognitive symptoms will help to identify those at risk for IFN -- associated depression among patients with chronic hepatitis C.


To study the effects of closure vs nonclosure of buccal mucosal graft harvest site .


Patients were randomized to either primary closure or nonclosure of buccal mucosal harvest site during urethroplasty .


Graft widths were standardized to 2 cm .


Prospective data were collected via patient visual analog scales ( 0-10 ) of 5 domains examining pain , numbness , tightness , drinking , and eating at postoperative day 1 and 3 and then at 3 weeks and 3 months until 1 year .


There were 34 patients who underwent randomization and completed the study .


The preoperative demographics between both groups were comparable with no significant differences .


The median age is 44 years .


There were 16 patients in the closure group and 18 patients in the nonclosure group .


The results show an improvement in the domains of pain ( P = .08 ) , drinking ( P = .06 ) , and eating ( P = .03 ) in favor of the closure group at postoperative day 1 and 3 .


There are no significant differences in all 5 domains between both groups after 3 weeks postoperatively


This study shows that primary closure of buccal mucosal graft bed improves pain as well as oral intake in the immediate postoperative period .


There are no long-term differences .


Uncertainty exists about the most effective route for delivery of early nutritional support in critically ill adults .


We hypothesized that delivery through the parenteral route is superior to that through the enteral route .


We conducted a pragmatic , randomized trial involving adults with an unplanned admission to one of 33 English intensive care units .


We randomly assigned patients who could be fed through either the parenteral or the enteral route to a delivery route , with nutritional support initiated within 36 hours after admission and continued for up to 5 days .


The primary outcome was all-cause mortality at 30 days .


We enrolled 2400 patients ; 2388 ( 99.5 % ) were included in the analysis ( 1191 in the parenteral group and 1197 in the enteral group ) .


By 30 days , 393 of 1188 patients ( 33.1 % ) in the parenteral group and 409 of 1195 patients ( 34.2 % ) in the enteral group had died ( relative risk in parenteral group , 0.97 ; 95 % confidence interval , 0.86 to 1.08 ; P = 0.57 ) .


There were significant reductions in the parenteral group , as compared with the enteral group , in rates of hypoglycemia ( 44 patients [ 3.7 % ] vs. 74 patients [ 6.2 % ] ; P = 0.006 ) and vomiting ( 100 patients [ 8.4 % ] vs. 194 patients [ 16.2 % ] ; P < 0.001 ) .


There were no significant differences between the parenteral group and the enteral group in the mean number of treated infectious complications ( 0.22 vs. 0.21 ; P = 0.72 ) , 90-day mortality ( 442 of 1184 patients [ 37.3 % ] vs. 464 of 1188 patients [ 39.1 % ] , P = 0.40 ) , in rates of 14 other secondary outcomes , or in rates of adverse events .


Caloric intake was similar in the two groups , with the target intake not achieved in most patients .


We found no significant difference in 30-day mortality associated with the route of delivery of early nutritional support in critically ill adults .


( Funded by the United Kingdom National Institute for Health Research ; CALORIES Current Controlled Trials number , ISRCTN17386141 . )


To evaluate the effect of the intravenous ( i.v. ) L-alanyl-L-glutamine dipeptide supplementation during 5 days on clinical outcome in trauma patients admitted to the intensive care unit ( ICU ) .


This was a prospective , randomized , double-blind , multicenter trial .


Glutamine was not given as a component of nutrition but as an extra infusion .


The primary outcome variable was the number of new infections within the first 14 days .


We included 142 patients .


There were no differences between groups in baseline characteristics .


Up to 62 % of the patients in the placebo group and 63 % in the treatment group presented confirmed infections ( p = 0.86 ) .


ICU length of stay was 14 days in both groups ( p = 0.54 ) .


Hospital length of stay was 27 days in the placebo group and 29 in the treatment group ( p = 0.88 ) .


ICU mortality was 4.2 % in both groups ( p = 1 ) .


Sixty percent of the patients presented low glutamine levels before randomization .


At the end of the treatment ( 6th day ) , 48 % of the patients maintained low glutamine levels ( 39 % of treated patients vs. 57 % in the placebo group ) .


Patients with low glutamine levels at day 6 had more number of infections ( 58.8 vs. 80.9 % ; p = 0.032 ) and longer ICU ( 9 vs. 20 days ; p < 0.01 ) and hospital length of stay ( 24 vs. 41 days ; p = 0.01 ) .


There was no benefit with i.v. L-alanyl-L-glutamine dipeptide supplementation ( 0.5 g/kg body weight/day of the dipeptide ) during 5 days in trauma patients admitted to the ICU .


The i.v. glutamine supplementation was not enough to normalize the plasma glutamine levels in all patients .


Low plasma glutamine levels at day 6 were associated with a worse outcome .


Dietary sodium restriction is a key management strategy in chronic kidney disease ( CKD ) .


Recent evidence has demonstrated short-term reduction in blood pressure ( BP ) and proteinuria with sodium restriction , however the effect on other cardiovascular-related risk factors requires investigation in CKD .


The LowSALT CKD study involved 20 hypertensive Stage III-IV CKD patients counselled by a dietitian to consume a low-sodium diet ( < 100mmol/day ) .


The study was a randomised crossover trial comparing 2weeks of high-sodium ( additional 120mmol sodium tablets ) and low-sodium intake ( placebo ) .


Measurements were taken after each crossover arm including BP ( peripheral and central ) , adipokines ( inflammation markers and adiponectin ) , volume markers ( extracellular-to-intracellular [ E/I ] fluid ratio ; N-terminal pro-brain natriuretic peptide [ NT-proBNP ] ) , kidney function ( estimated Glomerular Filtration Rate [ eGFR ] ) and proteinuria ( urine protein-creatinine ratio [ PCR ] and albumin-creatinine ratio [ ACR ] ) .


Outcomes were compared using paired t-test for each cross-over arm .


BP-lowering benefits of a low-sodium intake ( peripheral BP ( meanSD ) 148/8221/12mmHg ) from high-sodium ( 159/8715/10mmHg ) intake were reflected in central BP and a reduction in eGFR , PCR , ACR , NTproBNP and E/I ratio .


There was no change in inflammatory markers , total or high molecular weight adiponectin .


Short-term benefits of sodium restriction on BP were reflected in significant change in kidney function and fluid volume parameters .


Larger , long-term adequately powered trials in CKD are necessary to confirm these results .


Universal Trial Number U1111-1125-2149 registered on 13/10/2011 ; Australian New Zealand Clinical Trials Registry Number ACTRN12611001097932 registered on 21/10/2011 .


Endoscopic submucosal dissection ( ESD ) is a standard treatment for gastric neoplasia limited to the mucosa without lymph node metastasis .


However , there are neither standardized guidelines nor studies on the best time to start oral intake after ESD .


The aim of this study was to compare patient satisfaction , safety , length of hospital stay , and economic feasibility between an early post-ESD diet and the conventional immediate fasting protocol .


A total of 130 patients with 156 gastric epithelial neoplasias who underwent ESD by a single expert endoscopist were consecutively and prospectively enrolled .


Enrolled patients were randomized to an early diet group or a control group .


The early diet group started meals as a clear liquid diet on day 0 , and a soft diet and general diet in sequence on day 1 .


The fasting group was fasted for 2 days .


Patients in both groups underwent second-look endoscopy within 2 days following ESD and follow-up endoscopy after 2 months .


In the course of the study , ten patients were excluded .


The total number of patients in the early diet group and control group was 63 and 57 , respectively .


Mean age was 62 years ( 9.4 ) .


There were no significant differences in clinicopathologic conditions or endoscopic results such as procedure time or size of lesions between the two groups .


There were no significant differences in abdominal pain score , rate of post-ESD bleeding or healing rate of ESD-induced ulcer between the two groups .


However , the early diet protocol led to significantly higher patient satisfaction ( p = 0.001 ) , lower hospital costs ( p < 0.001 ) , and shorter hospital stay ( p < 0.001 ) than the conventional fasting protocol .


An early post-ESD diet protocol provides higher patient satisfaction , is more cost effective , decreases hospital stay , and does not influence complication rates such as post-ESD bleeding , abdominal pain , or ulcer healing compared with the conventional fasting protocol .


Internet-based applications are becoming more common in our modern world .


While electronic health records ( EHR ) are available for patients and health care providers outside of Germany , most of the available data on EHR address only monetary advantages.This study explores whether or not internet-based communication between family physicians ( FP ) and patients is as safe as traditional oral communication and if it may lead to further benefits .


500 patients from 14 family doctors ' offices were included in this 6 months RCT .


Both groups were treated in the same manner by their respective physicians , but members of the study group ( SG ) were able to access an individual developed web-based software where they could view their diagnosis and medication , and send an electronic message to their doctors who would respond .


Their satisfication with the FP , certain health data and the FP 's workload were recorded .


a ) Patients ' satisfaction : When e.g. asked about the organization of the family practice or trust in the doctor , there were no significant differences between the control ( CG ) and the SG ( p = 0.07 ; p = 0.53 ) .


However , patients of the SG felt better informed ( p = 0.01 ) , and generally more satisfied with their FP ( p = 0.04 ) .


b ) FP workload : Members of the CG had 8.44 contacts with their doctors during the study , while the SG only had 7.96 recorded contacts ( including web-based contacts , p = 0.32 ) .


It took physicians 3:52 minutes less to read and respond to an electronic message than to see a patient during the consultation hours .


c ) Changes in patients ' health : During the study the blood pressure ( BP ) in the CG rose 4.44 / 2.80 mmHg , while it dropped 3.13 / 4.36 mmHg in the SG ( p = 0.19 / 0.01 ) .


The HbA ( 1C ) dropped in both groups ( p = 0.91 ) .


One week after the first visit to the family doctor , patients of the SG rated their pain 0.28 points lower on a VAS than the CG ( p = 0.75 ) .


91 % from the CG and 96 % from the SG requested the re-prescription of long-term medication on time ( p = 0.16 ) .


Using an optional web-based communication platform is as safe as traditional consultations can be .


Both patients and doctors may benefit from using the internet in this context .


Many transfusion services are keeping thawed plasma ( TP ) ready for trauma patients .


According to Chinese guidelines , once thawed , fresh frozen plasma ( FFP ) should be used within 24h .


This may increase plasma wastage and delay plasma administration to critical patients .


However , it can be avoided by being relabeled as TP .


In this study we evaluated coagulation-related proteins in thawed apheresis FFP during 5 days of storage at 1-6 C.


Thirty apheresis fresh plasma units were aliquot and stored at -70 C. Aliquots were thawed at 37 C and stored at 1-6 C for 0 , 1 , 2 , 3 , 4 and 5 days , respectively .


Prothrombin time ( PT ) , activated partial thromboplastin time ( aPTT ) , thrombin time ( TT ) , fibrinogen ( Fbg ) , factor ( F ) II , FV , FVII , FVIII , FIX , FX , FXI , FXII , protein C ( PC ) , protein S ( PS ) , antithrombin III ( ATIII ) and ADAMTS13 levels were assessed at Days 0-5 , respectively .


For 5 days of refrigerated storage , no significant differences were observed in Fbg , PC , PS , ATIII and ADAMTS13 .


FII , FV , FVII , FVIII , FIX , FX , FXI and FXII declined significantly over time .


The storage presented major decrease for FVIII , with a drop of 40 % .


However , at least 60 % levels of all measured proteins were remained on Day 5 , when compared to Day 0 .


All measured proteins in TP for 5 days of refrigerated storage were adequate .


These could provide evidence that thawed FFP could be relabeled as TP , which is a potential to ensure rapid plasma availability in emergency situations in China .


To explore the clinical efficacy and safety of acupuncture and moxibustion for copracrasia .


By prospective live randomized controlled trial , 40 cases with copracrasia were randomly divided into an acupuncture-moxibustion group and a medication group , 20 cases in each one .


In the acupuncture-moxibustion group , acupuncture was applied at Ciliao ( BL 32 ) , Changqiang ( GV 1 ) and Tianshu ( ST 25 ) and mild moxibustion was used at Qihai ( CV 6 ) .


Treatment was given for 12 weeks and 32 times , 3 times a week in the front 8 weeks , 2 times a week in the latter 4 weeks .


In the medication group , conventional symptomatic treatment , support therapy , and complications preventing and treating were adopted for 12 weeks .


Anal incontinence score ( Vaizey incontinence score ) , effective rate and self-rating score for satisfaction were observed before and after treatment and in the follow-up period .


After 12 weeks ' treatment in the two groups , Vaizey incontinence ' scores were both decreased ( both P < 0.05 ) , and after treatment and in the follow-up period the scores in the acupuncture-moxibustion group were lower than those in the corresponding period in the medication group ( both P < 0.05 ) .


The effective rate of the acupuncture-moxibustion group was 80.0 % ( 16/20 ) , which was statistically different from 50.0 % ( 10/20 ) in the medication group ( P < 0.05 ) .


The effective rate in the follow-up period of the acupuncture-moxibustion group was 90.0 % ( 18/20 ) and it was not statistically different from 80.0 % ( 16/20 ) in the medication group ( P > 0.05 ) .


The self-rating scores for satisfaction in the acupuncture-moxibustion group were superior to those in the medication group after treatment and in the follow-up period ( both P < 0.05 ) .


Acupuncture and moxibustion could improve copracrasia and the acupuncture-moxibustion rules and characteristics for the disorder should be paid attention to in the further research .


Potential benefits of single-port laparoscopic surgery may include improved cosmetic results , less postoperative pain , surgical trauma and faster recovery .


Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented .


The aim of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances .


Patients with non-metastasized rectal cancer were prospectively randomized to single-port ( n = 20 ) or conventional laparoscopic rectal surgery ( n = 20 ) .


Postoperative pain was assessed at rest , at coughing and during mobilization , with a numeric pain ranking score and was recorded at 6 h after the operation and subsequently every morning daily for 4 days .


Levels of C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and tissue inhibitor of metalloproteinases-1 ( TIMP-1 ) were determined .


Blood samples were collected preoperatively ( baseline ) , and 6 , 24 , 48 , 72 and 96 h after skin incision .


Pain scores were significantly reduced in the single-port group on postoperative days 2 , 3 and 4 during coughing and mobilization .


In addition , the patients in the single-port group suffered significantly less pain at rest at 6 h after surgery and on postoperative days 1 , 3 and 4 .


The levels of the three markers increased significantly after surgery .


The increase was similar between groups for plasma IL-6 and TIMP-1 at all time points , while the CRP levels were significantly lower in the single-port group at 6 ( p < 0.001 ) and 24 h ( p < 0.05 ) after skin incision .


Abdominal incisions lengths were significantly shorter in the single-port group ( p = 0.001 ) .


There was no significant difference between groups in operating time and blood loss , morbidity or mortality rate .


The short-term oncological outcome in the two groups was similar .


Single-port rectal surgery may reduce postoperative pain .


Although CRP levels were lower at some time points , results of the present randomized , pilot study suggest that the trauma-induced inflammatory response of single-port operations may be similar to the trauma-induced inflammatory response of conventional laparoscopic surgery .


To compare in dual-energy CT ( DECT ) conventionally reconstructed polyenergetic images ( PEI ) at 120 kVp to virtual monoenergetic images ( MEI ) at different kiloelectron volt ( keV ) levels for evaluation of liver and gastrointestinal stromal tumor ( GIST ) hepatic metastases with regard to objective ( IQob ) and subjective image quality ( IQsub ) assessed by two readers of varying experience .


Image quality was correlated to patient size and compared between PEI and MEI .


From 50 examinations of 17 GIST patients ( 12 with hepatic metastases ) undergoing abdominal dual-source DECT for staging , therapy monitoring or follow-up , PEI and nine MEI in 10-keV intervals from 40 to 120 keV were reconstructed .


Liver contrast-to-noise ratios ( CNR ) and metastasis-to-liver ratios were calculated .


MEI reconstructions with the highest IQob were compared to PEI for IQsub by one experienced reader ( ER ) and one inexperienced reader ( IR ) .


Patients ' diameters were correlated to IQob and IQsub ratings .


MEI at 70 keV had the highest IQob with equal liver CNR and metastasis-to-liver ratio compared to PEI .


The ER rated 70-keV MEI and PEI equally high ( median 4 ) , whereas the IR rated IQsub best in 70-keV MEI ( median 5 ) .


Unlike in PEI , IQsub ratings in 70-keV MEI were not correlated to patient size .


MEI at 70 keV provided an IQob equivalent to PEI .


Regarding the IR , IQsub was improved in 70-keV MEI compared to PEI and less dependent on patient size .


Therefore , IRs might improve their diagnostic confidence in the assessment of hepatic GIST metastases by evaluating MEI reconstructions at 70 keV .


Current stroke risk schemes need improvement of predictive value in patients with atrial fibrillation .


Transoesophageal echocardiography ( TEE ) may facilitate stroke risk assessment in such patients and guide antithrombotic treatment .


We randomised 238 patients with non-valvular atrial fibrillation and a moderate stroke risk to aspirin or adjusted vitamin K antagonist therapy after TEE had ruled out thrombogenic features in the atria and aorta .


The primary outcome was a composite of stroke , major bleeding , peripheral embolism and all-cause mortality .


Mean CHA2DS2-VASc score was 2.11.1 .


The incidences of the composite primary outcome at a mean follow-up of 1.6 years were 3.2 % ( 2.02 % per year ) in the aspirin group compared to 6.1 % ( 3.84 % per year ) in the vitamin K antagonists group with an absolute advantage of 2.9 percentage points .


Aspirin was non-inferior to vitamin K antagonists ( p < 0.0001 ) because the upper limit of the 90 % CI did not exceed the 7 % absolute difference in event rate between the two treatment arms .


This hypothesis-generating pilot trial has found that TEE may be used for refinement of stroke risk in paroxysmal atrial fibrillation patients .


A larger trial is needed to confirm these data .


( ClinicalTrials.gov number NTC00224757 ) .


Insecticide-treated nets ( ITNs ) and indoor residual spraying ( IRS ) of houses provide effective malaria transmission control .


There is conflicting evidence about whether it is more beneficial to provide both interventions in combination .


A cluster randomised controlled trial was conducted to investigate whether the combination provides added protection compared to ITNs alone .


In northwest Tanzania , 50 clusters ( village areas ) were randomly allocated to ITNs only or ITNs and IRS .


Dwellings in the ITN+IRS arm were sprayed with two rounds of bendiocarb in 2012 .


Plasmodium falciparum prevalence rate ( PfPR ) in children 0.5-14 y old ( primary outcome ) and anaemia in children < 5 y old ( secondary outcome ) were compared between study arms using three cross-sectional household surveys in 2012 .


Entomological inoculation rate ( secondary outcome ) was compared between study arms .


IRS coverage was approximately 90 % .


ITN use ranged from 36 % to 50 % .


In intention-to-treat analysis , mean PfPR was 13 % in the ITN+IRS arm and 26 % in the ITN only arm , odds ratio = 0.43 ( 95 % CI 0.19-0 .97 , n = 13,146 ) .


The strongest effect was observed in the peak transmission season , 6 mo after the first IRS .


Subgroup analysis showed that ITN users were additionally protected if their houses were sprayed .


Mean monthly entomological inoculation rate was non-significantly lower in the ITN+IRS arm than in the ITN only arm , rate ratio = 0.17 ( 95 % CI 0.03-1 .08 ) .


This is the first randomised trial to our knowledge that reports significant added protection from combining IRS and ITNs compared to ITNs alone .


The effect is likely to be attributable to IRS providing added protection to ITN users as well as compensating for inadequate ITN use .


Policy makers should consider deploying IRS in combination with ITNs to control transmission if local ITN strategies on their own are insufficiently effective .


Given the uncertain generalisability of these findings , it would be prudent for malaria control programmes to evaluate the cost-effectiveness of deploying the combination .


www.ClinicalTrials.gov NCT01697852 Please see later in the article for the Editors ' Summary .


The OPTION ( Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications ) trial sought to compare long-term rates of inappropriate shocks , mortality , and morbidity between dual-chamber and single-chamber settings in implantable cardioverter-defibrillators ( ICDs ) patients .


The use of dual-chamber ICDs potentially allows better discrimination of supraventricular arrhythmias and thereby reduces inappropriate shocks .


However , it may lead to detrimental ventricular pacing .


This prospective multicenter , single-blinded trial enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and with left ventricular ejection fractions 40 % despite optimal tolerated pharmacotherapy .


All patients received atrial leads and dual-chamber defibrillators that were randomized to be programmed either with dual-chamber or single-chamber settings .


In the dual-chamber setting arm , the PARAD + algorithm , which differentiates supraventricular from ventricular arrhythmias , and SafeR mode , to minimize ventricular pacing , were activated .


In the single-chamber setting arm , the acceleration , stability , and long cycle search discrimination criteria were activated , and pacing was set to VVI 40 beats/min .


Ventricular tachycardia detection was required at rates between 170 and 200 beats/min , and ventricular fibrillation detection was activated above 200 beats/min .


During a follow-up period of 27 months , the time to the first inappropriate shock was significantly longer in the dual-chamber setting arm ( p = 0.012 , log-rank test ) , and 4.3 % of patients in the dual-chamber setting group compared with 10.3 % in the single-chamber setting group experienced inappropriate shocks ( p = 0.015 ) .


Rates of all-cause death or cardiovascular hospitalization were 20 % for the dual-chamber setting group and 22.4 % for the single-chamber setting group and satisfied the pre-defined margin for equivalence ( p < 0.001 ) .


Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings , without increases in mortality and morbidity .


( Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ ICD ] Patients Without Pacing Indications [ OPTION ] ; NCT00729703 ) .


The purpose of this study is to compare clinical outcomes in the treatment of deep non-contained intrabony defects ( i.e. , with 70 % 1-wall component and a residual 2 - to 3-wall component in the most apical part ) using deproteinized bovine bone mineral ( DBBM ) combined with either enamel matrix protein derivative ( EMD ) or collagen membrane ( CM ) .


Forty patients with multiple intrabony defects were enrolled .


Only one non-contained defect per patient with an intrabony depth 3 mm located in the interproximal area of single - and multirooted teeth was randomly assigned to the treatment with either EMD + DBBM ( test : n = 20 ) or CM + DBBM ( control : n = 20 ) .


At baseline and after 12 months , clinical parameters including probing depth ( PD ) and clinical attachment level ( CAL ) were recorded .


The primary outcome variable was the change in CAL between baseline and 12 months .


At baseline , the intrabony component of the defects amounted to 6.1 1.9 mm for EMD + DBBM and 6.0 1.9 mm for CM + DBBM sites ( P = 0.81 ) .


The mean CAL gain at sites treated with EMD + DBBM was not statistically significantly different ( P = 0.82 ) compared with CM + DBBM ( 3.8 1.5 versus 3.7 1.2 mm ) .


No statistically significant difference ( P = 0.62 ) was observed comparing the frequency of CAL gain 4 mm between EMD + DBBM ( 60 % ) and CM + DBBM ( 50 % ) or comparing the frequency of residual PD 6 mm between EMD + DBBM ( 5 % ) and CM + DBBM ( 15 % ) ( P = 0.21 ) .


Within the limitations of the present study , regenerative therapy using either EMD + DBBM or CM + DBBM yielded comparable clinical outcomes in deep non-contained intrabony defects after 12 months .


To compare the differences in the clinical function and lumbar and abdominal myodynamia in patiants of lumbar disc herniation treated with moxibustion at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) and acupuncture .


Forty cases were randomized into a moxibustion group and an acupuncture group , 20 cases in each group .


In the moxibustion group , the warm moxibustion was applied alternatively at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) once every other day , 1 h each time , once every day .


In the acupuncture group , acupuncture was applied to the corresponding acupoints based on the affected lumbar vertebras , such as Jiaji ( EX-B 2 ) , Shens-hu ( BL 23 ) , Dachangshu ( BL 25 ) and Huantiao ( GB 30 ) , etc. , once evey day 30 min each time .


The treatment for 3 weeks was taken as one session in each group .


Totally , one session treatment was required .


Surface electromyography ( SEMG ) of bilateral paraspinal muscle and rectus muscle , and JOA score of low back pain were observed in the two groups .


( 1 ) JOA score : the score of subjective symptoms , score of activity of daily living ( ADL ) and total score were improved obviously as compared with those before treatment in the two groups ( P < 0.01 , P < 0.05 ) .


The results of subjective symptoms score , score of ADL and total score in the acupuncture group were superior to those in the moxibustion group after treatment ( 6.95 + / -0.94 vs 5.50 + / -0.89,10.90 + / -1.86 vs 8.90 + / - 1.92,22.50 + / - 2.82 vs 19.35 + / - 2.70 , all P < 0.05 ) .


( 2 ) SEMG comparison : root-mean-square value ( RMS ) was all reduced in SEMG of the anteflexion , rear protraction , orthostatism , bilateral bending and neck and leg rear flexion for strengthening lumbar muscle as compared with those before treatment in the two groups ( P < 0.05 , P < 0.01 ) .


RMS of the anteflexion and bilateral bending in the acupunture group were reduced much obviously as compared with the moxibustion group .


In terms of sitting position anteflexion , rear protraction , orthostatism , bilateral bending and neck and leg rear flexion for strengthening lumbar muscle , median frequency ( MF ) after treatment was all improved as compared with that before treatment in the two groups ( P < 0.05 , P < 0.01 ) .


In terms of anteflexion , the electrode MF after treatment was improved much obviously in the acupuncture group ( P < 0.05 ) .


Moxibustion at Dazhui ( GV 14 ) and Guanyuan ( CV 4 ) and conventional acupuncture all improve muscle function , relieve muscle fatigue , increase the ability of anti-muscle fatigue , strengthen lumbar vertebral stability , release subjective symptoms and improve ADL .


But , the effects of moxibustion are slightly lower than those of acupuncture .


The aim of this study was to compare clinical outcomes and stability following immediate loading of two types of tapered implants in the partially edentulous posterior maxilla and mandible .


A randomized controlled trial with 1 year of follow-up was performed on participants missing two consecutive teeth in a posterior quadrant with tapered implants with a hybrid textured surface .


Group 1 received Osstem TSIII HA implants , and group 2 received Zimmer TSV implants .


Group 1 implants were 4.5 or 5.0 mm in diameter , and group 2 implants were 4.7 mm in diameter ; all implants were 10 mm long .


Subjects received provisional restorations within 48 hours .


Definitive restorations were provided 3 months ( mandible ) or 6 months ( maxilla ) later .


Outcome measures were survival and success rates , marginal bone level change , implant stability quotient , and peri-implant soft tissue indices .


Fifty participants completed the trial ( group 1 : 52 implants in 26 patients ; group 2 : 48 implants in 24 patients ) .


The success rates were similar -- 98.1 % in group 1 and 97.9 % in group 2 -- at 12 months after immediate loading , but marginal bone loss was significantly different according to the implant design .


Implant stability increased significantly in both arches .


There were no significant differences in soft tissue indices between implant systems .


If high primary stability is acquired , tapered implants with hybrid textured surfaces are predictable for immediate loading in the posterior maxilla and mandible .


In spite of the influence of implant design on marginal bone loss , all tapered implants showed successful clinical outcomes and stability in immediate loading .


Cardiac surgery and sternotomy are procedures accompanied by substantial postoperative pain which is challenging to treat .


In general , intravenous ( IV ) opioids are used in the immediate postoperative phase , followed by oral opioids .


Oral opioids are easier to use and generally less expensive .


Our goal was thus to determine whether a new opioid preparation provides adequate analgesia after sternotomy .


In particular , we tested the primary hypothesis that total opioid use ( in morphine equivalents ) is not greater with oral opioid compared with patient-controlled IV morphine .


Our secondary hypothesis was that analgesic efficacy is similar with oral and IV opioids .


A total of 51 patients having elective cardiac surgery were enrolled in this study .


After rapid postoperative respiratory weaning , the patients were randomised into one of two groups receiving different types of analgesia : oral Targin ( a combination of oxycodone-hydrochloride and the opioid antagonist naloxone hydrochloride-dihydrate ) or patient-controlled IV morphine .


Pain score ( visual analogue scale ) , sedation ( Ramsey score ) , respiratory rate and side effects were assessed at 3 , 5 , 7 , 9 and 11 h after surgery , and every 6 h throughout the third postoperative evening .


The total opioid dose in morphine equivalent doses was significantly lower with oral opioid than with IV morphine ( adjusted geometric means [ 95 % confidence interval ] : 34 [ 29 ; 38 ] vs. 69 [ 61 ; 78 ] mg , respectively ) .


Pain scores were similar in each group .


Analgesic quality was comparable with oral and IV opioids , suggesting that postoperative pain even after very painful procedures can be sufficiently managed with oral opioids .


To evaluate the safety and feasibility of percutaneous tract dilation by the one-stage method in preschool children .


Between April 2009 and February 2013 , all preschool ( < 6 years ) children who were candidates for percutaneous nephrolithotomy were enrolled in this prospective study .


Patients were randomly assigned to dilation by serial metallic dilators ( group I , 31 patients ) or dilation by one-stage Amplatz according to Frattini et al. [ J Endourol 2001 ; 15:919 -923 ] ( group II , 31 patients ) .


The primary endpoint of interest was fluoroscopy time .


Secondary endpoints included tract creation and dilation time , success rate and complications .


Stone-free status was defined as residuals 3 mm .


Age , stone size , operation success and operation time were not significantly different between the studied groups .


The most common stone composition was calcium oxalate in both groups .


The mean standard deviation of access and fluoroscopy times in groups I and II were 7.3 1.2 min vs. 5.9 1.5 min ( p > 0.05 ) and 70.0 8.9 s vs. 22.0 5.6 s ( p < 0.001 ) , respectively .


Postoperative complications included one case of postoperative fever lasting less than 48 h in group I.


Percutaneous tract dilation by the one-stage method is safe and effective .


Also , it is associated with considerably less radiation exposure in preschool children .


To evaluate the effect of dehydroepiandrosterone ( DHEA ) on infertility patients with diminished ovarian reserve undergoing in vitro fertilization .


This is a prospective study .


Ninety-five patients with diminished ovarian reserve were included in this study .


Of them , 42 patients were randomly allocated to the DHEA group , who received DHEA 75 mg daily for three consecutive menstrual cycles prior to IVF cycles , and 53 patients were allocated to the control group , who entered IVF cycles directly .


All patients were treated with the same ovarian stimulation protocol .


Follicular fluid samples from both groups were collected for bone morphogenetic protein-15 ( BMP-15 ) and growth differentiation factor-9 ( GDF-9 ) .


Fluid from the first aspirated follicle without any visible blood contamination was carefully collected .


In addition , day 3 Blood samples were collected pre - and post-treatment of DHEA for serum anti-Mullerian hormone ( AMH ) , follicle stimulating hormone ( FSH ) and estradiol ( E2 ) in the DHEA group .


The level of BMP-15 in follicular fluid samples from the DHEA group was significantly higher than that of the control samples ( P = .000 ) .


Patients after DHEA treatment demonstrated a significantly higher level of AMH and a significantly lower level of FSH , E2 compared to themselves prior to DHEA therapy ( P = .015 ; P = .036 ; P = .002 ; respectively ) .


Moreover , the accumulated score of embryos was significantly higher in the DHEA group ( P = .033 ) .


These observations confirm the beneficial effect of DHEA for infertility patients with diminished ovarian reserve .


ChiCTR-TRC-14005002 .


To compare subjective and objective visual performance of the Air Optix Aqua Multifocal lens to monovision in a group of subjects requiring a medium level of reading-addition power .


Fifty participants with reading additions between 1.25 and 2.00 diopters ( inclusive ) were randomized into a prospective , crossover clinical trial .


They wore monovision and multifocals for 2 weeks in a randomized order .


High - and low-contrast logMAR ( logarithm of the minimum angle of resolution ) acuity and stereopsis were measured at the beginning and end of each period .


During each phase , participants performed specific tasks followed by subjective rating surveys and also completed satisfaction rating surveys on days 3 , 7 , and 12 ; all were transferred in real time using BlackBerry smartphones .


A general rating survey was completed at the dispensing and 2-week visits .


Forty-nine participants completed the study ( mean age , 52 years ) .


Distance and near high - and low-contrast acuities were significantly better ( p < 0.05 ) with monovision at all visits .


High-contrast intermediate acuity was only better ( p < 0.05 ) with multifocals after 2 weeks .


Stereopsis was equivalent after 2 weeks , but better ( p < 0.05 ) with multifocals at dispensing .


Subjective ratings were generally equivalent between modalities although there was a trend for multifocals to be rated higher for focus changing and driving , whereas monovision tended to be rated higher for near tasks .


For both corrections , the satisfaction survey showed no significant change between days 3 , 7 , and 12 , and the general survey showed that comfort was maintained but subjective vision ratings decreased significantly over the 2 weeks .


Twenty-five participants ( 51 % ) preferred multifocals , 18 ( 37 % ) preferred monovision , and the remaining 6 ( 12 % ) declared both unacceptable .


In this cohort , distance and near acuities were better with monovision , whereas the subjective ratings tended to favor the Air Optix Aqua Multifocal , with the exception of near performance .


Preference was statistically similar between both corrections , with a trend toward preferring the multifocal .


Natural orifice transluminal endoscopic surgery ( NOTES ) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma .


The potential benefits are expected to be less postoperative pain , faster convalescence , and reduced risk for incisional hernias and wound infections compared to conventional methods .


Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES , and transvaginal access is currently the most frequent clinically applied route for NOTES procedures .


However , despite increasing clinical application , no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard .


The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection .


Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible .


The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale ( VAS ) .


Secondary outcomes include daily pain intensity and analgesic use , patient mobility , intraoperative complications , morbidity , length of stay , quality of life , and sexual function .


Follow-up visits are scheduled 3 , 12 , and 36 months after surgery .


A total sample size of 58 patients was determined for the analysis of the primary endpoint .


The confirmatory analysis will be performed based on the intention-to-treat ( ITT ) principle .


The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting .


The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection .


The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995 ) on March 27 , 2014 .


Aetiology of childhood leukaemia and childhood neoplasm is poorly understood .


Information on the prevalence of risk factors in the childhood population is limited .


SETIL is a population based case-control study on childhood leukaemia , conducted with two companion studies on non-Hodgkin Lymphoma ( NHL ) and neuroblastoma .


The study relies on questionnaire interviews and 50 Hz magnetic field ( ELF-MF ) indoor measurements .


This paper discusses the SETIL study design and includes descriptive information .


The study was carried out in 14 Italian regions ( 78.3 % of Italian population aged 0-10 ) .


It included leukaemia , NHL and neuroblastoma cases incident in 0-10 year olds in 1998-2001 , registered by the Italian Association of Paediatric Haematology and Oncology ( AIEOP ) ( accrual over 95 % of estimated incidence ) .


Two controls for each leukaemia case were randomly sampled from the Local Health Authorities rolls , matched by gender , birthdate and residence .


The same controls were used in NHL and neuroblastoma studies .


Parents were interviewed at home on : physical agents ( ELF-MF and ionizing radiation ) , chemicals ( smoking , solvents , traffic , insecticides ) , occupation , medical and personal history of children and parents , infectious diseases , immunizations and associated factors .


Occupational exposure was collected using job specific modules .


ELF-MF was measured in the main rooms ( spot measurement ) and close to child 's bed ( 48 hours measurement ) .


The study included : 683 leukaemia cases ( 87 % ALL , 13 % AnLL ) , 97 NHL , 155 neuroblastomas , and 1044 controls .


SETIL represents a data source on exposure of Italian children to a broad array of potential carcinogenic factors .


Highly HLA-sensitized ( HS ) patients have difficulty accessing compatible donors , especially deceased donor ( DD ) transplants .


Desensitization protocols ( DES ) have evolved , but rigorous evaluation is lacking .


Here , we examined the efficacy of rituximab as a DES agent in a placebo-controlled trial .


Candidates were randomized to IVIG + placebo versus IVIG + rituximab .


End points included rates of transplantation , antibody-mediated rejection ( ABMR ) , and renal function .


Protocol biopsies were performed at 1 year and analysis of patient and graft survival and donor-specific HLA antibodies ( DSA ) were performed .


Initially , 15 HS DDs were randomized with 13 receiving transplants .


However , we discontinued study entry after five serious adverse events were observed .


The study was un-blinded and attribution of patients was noted ( IVIG + placebo N = 7 , IVIG + rituximab N = 6 ) .


No significant differences were seen in DSA levels at transplant .


All ABMR episodes occurred in the IVIG + placebo arm and required intense therapy ( P = 0.06 ) .


The two graft losses were in the placebo group .


DSA rebound associated with severe ABMR was seen in three patients in the IVIG + placebo group .


No rebound was seen in the IVIG + rituximab group .


Renal function at 6 and 12 months showed a significant benefit for IVIG + rituximab ( P = 0.04 ) .


Based on limited assessment with acknowledged limitations , both protocols appear effective in achieving levels of DSA allowable for transplantation .


However , IVIG + rituximab appeared more effective in preventing DSA rebound and , more importantly , preventing ABMR and development of transplant glomerulopathy .


To evaluate the clinical efficacy and safety of tissue-selecting therapy ( TST ) in treatment of mixed hemorrhoids .


A single-blind randomized study was carried out .


A total of 120 patients with mixed hemorrhoids from January to December 2012 were prospectively enrolled in the study and equally divided into two groups , TST group and procedure for prolapse and hemorrhoids ( PPH ) group .


Surgical data , efficacy and postoperative complications were compared between the two groups .


As compared to PPH group , patients in TST group had shorter operation time [ ( 15.95.18 ) min vs. ( 22.67.1 ) min , P < 0.05 ] , lower scores of rectal urgency ( 0.50.2 vs. 1.51.4 , P < 0.05 ) , and shorter hospital stay [ ( 11.23.7 ) d vs. ( 14.83.7 ) d , P < 0.05 ] .


No anastomotic stricture case was found in TST group , while 11 cases ( 18.3 % ) developed anastomotic stricture in PPH group .


There were no significant differences in effective rate and pain score of first defecation between the two groups .


TST is reliable and safe for mixed hemorrhoids with the advantage of simple , rapid recovery and less complications .


The surgical removal of mandibular third molars is frequently accompanied by significant postsurgicalsequelae , and different protocols have been described to decrease such adverse events .


The aim of this study was to investigate the performance of piezosurgery compared with traditional rotating instrumentsduring mandibular third molar removal .


A single-center , randomized , split-mouth study was performed using a consecutive series of unrelated healthy patients attending the Oral Surgery Unit of the University of Turin for surgical removal of bilateral mandibular third molar teeth .


Each patient was treated , at the same appointment , using bur removal on 1 side of the mandible and a piezoelectric device on the contralateral side .


The primaryoutcomes reported were postoperative pain , objective orofacial swelling , and surgical duration ; secondary outcomes were gender , age , and possible adverse events .


Analysis of variance or paired t test was used as appropriate to test any significant differences at baseline according to each treatment subgroup , and categorical variables were analyzed by ( 2 ) test .


The study sample consisted of 100 otherwise healthy patients .


The mean pain evaluation reportedby patients who underwent surgery with piezosurgery was significantly lower than that reported after bur ( conventional ) removal , reaching statistical difference after 4 days ( P = .043 ) .


The clinical value oforofacial swelling at day 7 , normalized to baseline , was lower in the piezosurgery group ( P < .005 ) .


Theaverage surgical duration was significantly shorter in the bur group than in the piezosurgery group ( P < .05 ) .


Three patients having bur removal developed short-term complications ( 2 dry sockets and 1temporaryparaesthesia ) , which totally resolved by 4 weeks .


To date , this prospective investigation is the largest reported split-mouth study on piezosurgeryfor lower third molar tooth removal .


This study also compared surgeons with different degreesof experience .


It is evident that using a piezoelectric device can enhance the patient experience and decrease postoperative pain and swelling .


To evaluate efficacy and safety of eszopiclone compared with placebo in children and adolescents with insomnia associated with attention-deficit/hyperactivity disorder ( ADHD ) .


A 12-week , randomized , double-blind , placebo-controlled trial evaluated efficacy and safety of high - or low-dose eszopiclone ( 1 or 2 mg in children aged 6-11 years , 2 or 3 mg in children ages 12-17 years ) , given every evening , in 486 patients with ADHD-related insomnia .


The primary efficacy variable was change in latency to persistent sleep from baseline to week 12 , based on polysomnography .


Key secondary measures were polysomnography-measured wake time after sleep onset , Clinical Global Impression Parent/Caregiver and Child scales , and the Conners ' ADHD rating scales .


The safety of eszopiclone was further studied over 1 year of open-label treatment in 55 patients who completed the double-blind study , and 249 patients with no previous eszopiclone exposure .


Neither low-dose nor high-dose eszopiclone significantly reduced latency to persistent sleep compared with placebo after 12 weeks of treatment .


Secondary outcomes were considered nonsignificant based on the hierarchical statistical analysis plan .


The most frequent treatment-emergent adverse events over 12 weeks with eszopiclone were headache , dysgeusia , and dizziness .


The study results demonstrated that eszopiclone was well tolerated over 1 year of treatment , with 11.2 % of patients discontinuing open-label treatment because of an adverse event .


Eszopiclone ( up to 3 mg ) failed to reduce latency to persistent sleep on polysomnography after 12 weeks in children aged 6 to 17 years with ADHD-related insomnia .


Eszopiclone was well tolerated in the 1-year study .


Cognitive-behavioral therapy ( CBT ) has demonstrated efficacy and effectiveness for treating mood and anxiety disorders .


Dissemination of CBT via videoconference may help improve access to treatment .


The present study aimed to compare the effectiveness of CBT administered via videoconference to in-person therapy for a mixed diagnostic cohort .


A total of 26 primarily Caucasian clients ( mean age 30 years , SD 11 ) who had a primary Diagnostic and Statistical Manual of Mental Disorders , 4th edition text revision ( DSM-IV-TR ) diagnosis of a mood or anxiety disorder were randomly assigned to receive 12 sessions of CBT either in-person or via videoconference .


Treatment involved individualized CBT formulations specific to the presenting diagnosis ; all sessions were provided by the same therapist .


Participants were recruited through a university clinic .


Symptoms of depression , anxiety , stress , and quality of life were assessed using questionnaires before , after , and 6 weeks following treatment .


Secondary outcomes at posttreatment included working alliance and client satisfaction .


Retention was similar across treatment conditions ; there was one more client in the videoconferencing condition at posttreatment and at follow-up .


Statistical analysis using multilevel mixed effects linear regression indicated a significant reduction in client symptoms across time for symptoms of depression ( P < .001 , d = 1.41 ) , anxiety ( P < .001 , d = 1.14 ) , stress ( P < .001 , d = 1.81 ) , and quality of life ( P < .001 , d = 1.17 ) .


There were no significant differences between treatment conditions regarding symptoms of depression ( P = .165 , d = 0.37 ) , anxiety ( P = .41 , d = 0.22 ) , stress ( P = .15 , d = 0.38 ) , or quality of life ( P = .62 , d = 0.13 ) .


There were no significant differences in client rating of the working alliance ( P = .53 , one-tailed , d = -0.26 ) , therapist ratings of the working alliance ( P = .60 , one-tailed , d = 0.23 ) , or client ratings of satisfaction ( P = .77 , one-tailed , d = -0.12 ) .


Fisher 's Exact P was not significant regarding differences in reliable change from pre - to posttreatment or from pretreatment to follow-up for symptoms of depression ( P = .41 , P = .26 ) , anxiety ( P = .60 , P = .99 ) , or quality of life ( P = .65 , P = .99 ) but was significant for symptoms of stress in favor of the videoconferencing condition ( P = .03 , P = .035 ) .


Difference between conditions regarding clinically significant change was also not observed from pre - to posttreatment or from pretreatment to follow-up for symptoms of depression ( P = .67 , P = .30 ) , anxiety ( P = .99 , P = .99 ) , stress ( P = .19 , P = .13 ) , or quality of life ( P = .99 , P = .62 ) .


The findings of this controlled trial indicate that CBT was effective in significantly reducing symptoms of depression , anxiety , and stress and increasing quality of life in both in-person and videoconferencing conditions , with no significant differences being observed between the two .


Australian New Zealand Clinical Trials Registry ID : ACTRN12609000819224 ; http://www.anzctr.org.au/ACTRN12609000819224.aspx ( Archived by WebCite at http://www.webcitation.org/6Kz5iBMiV ) .


The aim of this study was to investigate the effects of mass drug administration on Schistosoma mansoni prevalence and associated liver morbidity in treated school-aged children and untreated preschool children .


In April 2008 , parasitological ( using the Kato-Katz method ) and morbidity ( determined by portal vein score ) data were collected from 263 schoolchildren aged 6 and 7 years .


The children had never received praziquantel .


In March 2010 , following two annual rounds of mass drug administration , 207 children aged 8 and 9 years old were examined to determine the effect of treatment .


In addition , 158 untreated 6-year-olds were assessed to compare with the untreated children from 2008 .


Treatment significantly decreased the prevalence of S. mansoni and associated morbidity in the treated groups .


The untreated preschool children also showed a significant decrease in the prevalence of S. mansoni , from 21.1 % ( 2008 ) to 6.3 % ( 2010 ) ( p < 0.001 ) .


The percentage of untreated schoolchildren with a normal portal vein score increased significantly from 57.8 % ( 2008 ) to 70.3 % ( 2010 ) ( p = 0.029 ) .


The significantly lower rates of S. mansoni and the decreased liver morbidity in untreated preschool children in 2010 suggest decreased environmental transmission rates and improved liver morbidity in untreated children following several rounds of mass drug administration .


To evaluate the efficacy of a large capsulorhexis and intraocular lens ( IOL ) in obtaining a larger anterior capsule opening after cataract surgery in patients with diabetes mellitus ( DM ) .


Department of Ophthalmology , University of Fukui , Fukui , Japan .


Prospective clinical trial .


Patients with DM had bilateral cataract surgery with a 2.8 or 3.0 mm scleral incision , a capsulorhexis with a diameter of approximately 5.0 or 6.0 mm , and implantation of a 6.0 mm optic ( Eternity X-60 ) or 7.0 mm optic ( Eternity X-70 ) IOL .


The anterior capsule opening area , aqueous flare intensity , surgically induced astigmatism ( SIA ) , corneal endothelial cell density ( ECD ) , and central corneal thickness ( CCT ) were measured 1 day , 1 week , and 1 , 3 , and 6 months after surgery .


Thirty-one patients ( 62 eyes ) with DM were enrolled .


At all postoperative timepoints , the anterior capsule opening was significantly larger in eyes with the 7.0 mm optic IOL than in eyes with the 6.0 mm optic IOL ( P < .05 , Mann-Whitney U test ) .


There were no significant differences in postoperative aqueous flare intensity , SIA , ECD , or CCT based on the size of the capsulorhexis and IOL .


A larger capsulorhexis and implantation of a 7.0 mm IOL resulted in a larger anterior capsule opening after cataract surgery in patients with DM .


No author has a financial or proprietary interest in any material or method mentioned .


We sought to determine the dose-response effects of extended-release ( ER ) dexmethylphenidate ( d-MPH ) and ER mixed amphetamine salts ( MAS ) on objective measures of sleep .


This was an 8-week , double-blind , placebo-controlled , randomized , two period , crossover study of youth with attention-deficit hyperactivity disorder ( ADHD ) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children-Present and Lifetime version ( K-SADS-PL ) .


Children aged 10-17 years were recruited from clinical practice , colleague referrals , and flyers .


Participants were randomized to initially receive either d-MPH or MAS .


During each 4-week drug period , children received three dose levels ( 10 , 20 , and 25/30mg ) in ascending order , with placebo substituted for active medication in a randomized fashion during 1week of the study .


After 4weeks , participants were switched to the alternative medication for another 4weeks of treatment .


The main outcome measure was sleep duration as measured by actigraphy .


Children , parents , and researchers were blinded to drug , dose , and placebo status .


Sixty-five participants met the inclusion criteria and were enrolled in the study .


Of these , 37 participants with sufficient sleep data for analysis were included .


Sleep schedule measures showed a significant effect for dose on sleep start time ( F ( 1,36 ) = 6.284 ; p < 0.05 ) , with a significantly later sleep start time when children were receiving 20 - or 30-mg doses , compared with placebo ( p < 0.05 ) .


A significant dose effect was found on actual sleep duration ( F ( 1,36 ) = 8.112 ; p < 0.05 ) , with significantly shorter actual sleep duration for subjects receiving 30mg compared with those receiving placebo ( p < 0.05 ) .


There were no significant differences on sleep duration or sleep schedule between the two stimulant medications .


The trial is complete and closed to follow-up .


Higher stimulant doses were associated with reduced sleep duration and later sleep start times , regardless of medication class .


ClinicalTrials.gov : NCT00393042 .


Survival rates after sudden cardiac arrest could be increased if bystanders could be encouraged to perform CPR until emergency services arrive .


This should be initiated by the dispatcher at the emergency control facility who receives the call .


For the first time the ERC guidelines of 2010 included instructions to be given to untrained rescuers by the dispatcher .


Rapid recognition of cardiac arrest and initiation of emergency measures is assured by means of specific training for the dispatchers .


The aim of this investigation was to determine whether the time between an emergency call and beginning of cardiopulmonary resuscitation ( CPR ) could be shortened using a simple protocol and whether a relationship exists between the intensity of phone contact between dispatcher and caller and if this improves the results .


In known cases of unconsciousness , group 1 ( 45 persons ) received short CPR instructions via the phone , where the dispatcher was on the phone for continuous advice until emergency services arrived .


Group 2 ( 45 persons ) received identical phone instructions like group 1 , but the phone call was terminated by the dispatcher after the information was provided .


Group 3 ( 29 persons ) only received instructions to start CPR .


On average , all test persons in group 1 started reanimation after 68.033.5 s , in group 2 after 68.325.2 s , and in group 3 after 64.934.4 s.


The compression frequency on average was 98.3 / min in group 1 , 84.8 / min in group 2 , and 85.2 / min in group 3 ; therefore , all groups reached an average frequency of > 80/min .


The correct compression depth was achieved by 47.8 % of test persons in group 1 , by 44.2 % in group 2 , and by 30.2 % in group 3 .


All volunteers felt well supported .


Of the 90 people , 70 did not feel that they were missing instructions .


There were no significant differences between the groups regarding the target variables .


The results show that already extremely short instructions or advice by the dispatcher to start CPR is sufficient to encourage bystanders to give assistance in an emergency .


Continuous support over the phone does not appear to be necessary .


To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain control after gynecologic laparoscopy .


Evidence obtained from a properly designed , randomized , double-blind , placebo-controlled trial ( Canadian Task Force classification I ) .


Tertiary care center .


One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy .


Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery ( preoperative group ) , nebulization of 30 mg ropivacaine after surgery ( postoperative group ) , instillation of 100 mg ropivacaine before surgery ( instillation group ) , or instillation of saline solution ( control group ) .


Nebulization was performed using the Aeroneb Pro device .


Pain scores , morphine consumption , and ambulation time were collected in the post-anesthesia care unit and at 4 , 6 , and 24 hours postoperatively .


One hundred eighteen patients completed the study .


Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group ( net difference 2 points ; 95 % confidence interval [ CI ] , 0.3-3 .1 at 4 hours , 1-3 at 6 hours , and 0.7-3 at 24 hours ; p = .01 ) Patients in the preoperative group consumed significantly less morphine than did those in the control group ( net difference 7 mg ; 95 % CI , 0.7-13 ; p = .02 ) .


More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups ( net difference 15 % ; 95 % CI , 6 % -24 % ; p = .001 ) .


Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance .


The purpose of this study was to verify the influence of prebrushing mouthwashes on dental plaque removal in children .


This study had a double-blind , randomized , controlled , crossover , 25-day experimental design , including 38 12 - to 14-year-olds .


Four solutions were used as prebrushing mouthwashes ( Colgate Plax Magic , Listerine Cool Blue Agent , water and dye , and water ) by each participant with seven days ' washout .


The plaque index was evaluated before and after tooth-brushing during the experimental period .


Intergroup comparisons showed no significant differences in plaque reduction among evaluated solutions ( Friedman test , P > .78 ) .


Significantly more plaque was present before vs. after tooth-brushing ( Wilcoxon rank test , P < .001 ) , independent of the surface ( buccal or lingual/palatal ) .


Use of prebrushing mouthwashes by children does not influence plaque removal by tooth-brushing .


Treatments of eating disorders result too often in partial psychological and physical remission , chronicization , dropout , relapse and death , with no fully known explanations for this failure .


In order to clarify this problem , we conducted three studies to identify the biochemical background of cognitive-behavioural psychotherapy ( CBT ) , individual psychology brief psychotherapy ( IBPP ) , and psychotherapy-pharmacotherapy with CBT + olanzapine in anorexics ( AN ) and bulimics ( BN ) by measuring the levels of plasma homovanillic acid ( HVA ) for dopamine secretion , plasma 3-methoxy-4-hydroxy-phenylglycol ( MHPG ) for noradrenalin secretion , and platelet [ 3H ] - Paroxetin-binding Bmax and Kd for serotonin transporter function .


The data were then compared with psychopathological and physical alterations .


Study 1 investigated the effects of 4 months of CBT on plasma HVA , MHPG and [ 3H ] - Par-binding in 14 AN-restricted , 14 AN-bingeing/purging , and 22 BN inpatients .


Study 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients .


Study 3 investigated the effect of 3 months of CBT + olanzapine ( 5 mg/day ) in 30 AN outpatients .


The data were analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters , two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups , Spearman 's test for the correlations between basal and final changes in the psychological and biological scores .


Study 1 revealed significant amelioration of the psychopathology in the AN and BN patients , no effects on HVA , MHPG or Paroxetin binding Kd , and a significant increase in Par-binding Bmax only in the BN patients .


Study 2 revealed a significant effect of IBPP on psychopathology in the AN and BN patients , and a significant increase in HVA only in the BN patients .


Study 3 revealed a significant positive effect of CBT + olanzapine therapy on the psychopathology and increased HVA values .


No correlations were observed in the 3 groups between biological and psychological effects of the three treatments .


Our data advance suggestions on the mechanism of action of the three therapies ; however , the lack of correlations between biochemical and psychological effects casts doubt on their significance .


Clinical Trials.gov .


Identifier NCT01990755 .


This study explored the interest in genomic testing for modest changes in colorectal cancer risk and preferences for receiving genomic risk communications among individuals with intermediate disease risk due to a family history of colorectal cancer .


Surveys were conducted on 272 men and women at intermediate risk for colorectal cancer enrolled in a randomized trial comparing a remote personalized risk communication intervention ( TeleCARE ) aimed at promoting colonoscopy to a generic print control condition .


Guided by Leventhal 's Common Sense Model of Self-Regulation , we examined demographic and psychosocial factors possibly associated with interest in SNP testing .


Descriptive statistics and logistic regression models were used to identify factors associated with interest in SNP testing and preferences for receiving genomic risk communications .


Three-fourths of participants expressed interest in SNP testing for colorectal cancer risk .


Testing interest did not markedly change across behavior modifier scenarios .


Participants preferred to receive genomic risk communications from a variety of sources : printed materials ( 69.5 % ) , oncologists ( 54.8 % ) , primary-care physicians ( 58.4 % ) , and the web ( 58.1 % ) .


Overall , persons who were unmarried ( p = 0.029 ) , younger ( p = 0.003 ) and with greater cancer-related fear ( p = 0.019 ) were more likely to express interest in predictive genomic testing for colorectal cancer risk .


In a stratified analysis , cancer-related fear was associated with the interest in predictive genomic testing in the intervention group ( p = 0.017 ) , but not the control group .


Individuals with intermediate familial risk for colorectal cancer are highly interested in genomic testing for modest increases in disease risk , specifically unmarried persons , younger age groups and those with greater cancer fear .


Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited .


Using a parallel arm cluster-randomized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline-indicated risk factor measurements and ( 2 ) guideline-indicated medications for those at high cardiovascular disease risk .


Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Islander people aged 35 years and others aged 45 years ) .


Patient-level analyses were conducted using generalized estimating equations to account for clustering .


Median follow-up for 38,725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months .


Mean monthly staff support was < 1 hour/site .


For the coprimary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04-1 .50 ; P = 0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n = 10,308 ; 56.8 % versus 51.2 % ; P = 0.12 ) .


There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 17.9 % versus 2.7 % ; P < 0.001 ) , lipid-lowering ( 19.2 % versus 4.8 % ; P < 0.001 ) , and blood pressure-lowering medications ( 23.3 % versus 12.1 % ; P = 0.02 ) .


In Australian primary healthcare settings , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group .


Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management .


https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336630 .


Australian New Zealand Clinical Trials Registry No. 12611000478910 .


The Centre for the AIDS Programme of Research in South Africa ( CAPRISA ) 004 trial demonstrated a 39 % reduction in HIV infection , with a 54 % HIV reduction in women who used tenofovir gel consistently .


A confirmatory trial is expected to report results in early 2015 .


In the interim , we have a unique window of opportunity to prepare for and devise effective strategies for the future policy and programmatic scale-up of tenofovir gel provision .


One approach is to integrate tenofovir gel provision into family planning ( FP ) services .


The CAPRISA 008 implementation trial provides an opportunity to provide post-trial access to tenofovir gel while generating empiric evidence to assess whether integrating tenofovir gel provision into routine FP services can achieve similar levels of adherence as the CAPRISA 004 trial .


This is a two-arm , open-label , randomized controlled non-inferiority trial .


A maximum of 700 sexually active , HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral prevention study will be enrolled from an urban and rural site in KwaZulu-Natal , South Africa .


The anticipated study duration is 30 months , with active accrual requiring approximately 12 months ( following which an open cohort will be maintained ) and follow-up continuing for approximately 18 months .


At each of the two sites , eligible participants will be randomly assigned to receive tenofovir gel through either FP services ( intervention arm ) or through the CAPRISA research clinics ( control arm ) .


As part of the study intervention , a quality improvement approach will be used to assist the FP services to expand their current services to include tenofovir gel provision .


This protocol aims to address an important implementation question on whether FP services are able to effectively incorporate tenofovir gel provision for this at-risk group of women in South Africa .


Provision of tenofovir gel to the women from the CAPRISA 004 trial meets the ethical obligation for post-trial access , and helps identify a potential avenue for future scale-up of microbicides within the public health system of South Africa .


This trial was registered with the South Africa Department of Health ( reference : DOH-27-0812-4129 ) and ClinicalTrials.gov ( reference : NCT01691768 ) on 05 July 2012 .


Food residue in the remnant stomach after subtotal gastrectomy ( STG ) interferes with endoscopic observation .


We investigated whether intravenous erythromycin improves gastric mucosa visualization in patients with STG .


This study was conducted from April 2012 to October 2012 as a double-blinded , placebo-controlled , randomized trial .


Patients who received STG with complete resection ( stage T1-2N0M0 ) were included .


Exclusion criteria were diabetes mellitus , neurologic disease , myopathy , recent viral enteritis history , concomitant therapy influencing gastrointestinal motility and severe comorbidity .


Patients were instructed to consume a soft diet for dinner between 1800 and 2000 h , and endoscopies were performed between 0900 and 1200 h. Patients were assigned randomly to receive either erythromycin ( 125 mg in normal saline 50 cc ) or placebo saline .


The endoscopy was performed 15 min after infusion .


Grade of residual food was rated as follows : G0 , no residual food ; G1 , a small amount of residual food ; G2 , a moderate amount of residual food ; G3 , a moderate amount of residual food that hinders observation of the entire surface , even with body rolling ; G4 , a great amount of residual food such that endoscopic observation is impossible .


When good visibility was defined as G0 + G1 , visibility was significantly better in the erythromycin group ( 61 + 19 % ) than in the placebo group ( 38 + 12 % , p < 0.001 ) .


However , this effect was not seen in patients within 6 months after gastrectomy .


The risk factor for food stasis in the placebo group ( n = 58 ) was food stasis at last endoscopy .


The only factor predicting erythromycin response in the erythromycin group ( n = 56 ) was elapsed time since surgery .


Adverse effects included nausea [ 11 ( 19.7 % ) ] and vomiting [ 1 ( 1.8 % ) ] in the erythromycin group and vomiting [ 3 ( 5.2 % ) ] in the placebo group .


However , they were transient and tolerable .


Premedication with erythromycin improves mucosal visualization during endoscopy in patients with STG .


NCT01659619 ) .


To test the hypothesis that daily acute intermittent hypoxia ( dAIH ) and dAIH combined with overground walking improve walking speed and endurance in persons with chronic incomplete spinal cord injury ( iSCI ) .


Nineteen subjects completed the randomized , double-blind , placebo-controlled , crossover study .


Participants received 15 , 90-second hypoxic exposures ( dAIH , fraction of inspired oxygen [ Fio2 ] = 0.09 ) or daily normoxia ( dSHAM , Fio2 = 0.21 ) at 60-second normoxic intervals on 5 consecutive days ; dAIH was given alone or combined with 30 minutes of overground walking 1 hour later .


Walking speed and endurance were quantified using 10-Meter and 6-Minute Walk Tests .


The trial is registered at ClinicalTrials.gov ( NCT01272349 ) .


dAIH improved walking speed and endurance .


Ten-Meter Walk time improved with dAIH vs dSHAM after 1 day ( mean difference [ MD ] 3.8 seconds , 95 % confidence interval [ CI ] 1.1-6 .5 seconds , p = 0.006 ) and 2 weeks ( MD 3.8 seconds , 95 % CI 0.9-6 .7 seconds , p = 0.010 ) .


Six-Minute Walk distance increased with combined dAIH + walking vs dSHAM + walking after 5 days ( MD 94.4 m , 95 % CI 17.5-171 .3 m , p = 0.017 ) and 1-week follow-up ( MD 97.0 m , 95 % CI 20.1-173 .9 m , p = 0.014 ) .


dAIH + walking increased walking distance more than dAIH after 1 day ( MD 67.7 m , 95 % CI 1.3-134 .1 m , p = 0.046 ) , 5 days ( MD 107.0 m , 95 % CI 40.6-173 .4 m , p = 0.002 ) , and 1-week follow-up ( MD 136.0 m , 95 % CI 65.3-206 .6 m , p < 0.001 ) .


dAIH walking improved walking speed and distance in persons with chronic iSCI .


The impact of dAIH is enhanced by combination with walking , demonstrating that combinatorial therapies may promote greater functional benefits in persons with iSCI .


This study provides Class I evidence that transient hypoxia ( through measured breathing treatments ) , along with overground walking training , improves walking speed and endurance after iSCI .


Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma .


Locally applied heparin attenuates lung injury in animal models of smoke inhalation .


Whether local treatment with heparin benefits patients with inhalation trauma is uncertain .


The present trial aims at comparing a strategy using frequent nebulizations of heparin with standard care in intubated and ventilated burn patients with bronchoscopically confirmed inhalation trauma .


The Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma ( HEPBURN ) is an international multi-center , double-blind , placebo-controlled , two-arm study .


One hundred and sixteen intubated and ventilated burn patients with confirmed inhalation trauma are randomized to nebulizations of heparin ( the nebulized heparin strategy ) or nebulizations of normal saline ( the control strategy ) every four hours for 14days or until extubation , whichever comes first .


The primary endpoint is the number of ventilator-free days , defined as days alive and breathing without assistance during the first 28days , if the period of unassisted breathing lasts for at least 24 consecutive hours .


As far as the authors know , HEPBURN is the first randomized , placebo-controlled trial , powered to investigate whether local treatment with heparin shortens duration of ventilation of intubated and ventilated burn patients with inhalation trauma .


NCT01773083 ( http://www.clinicaltrials.gov ) , registered on 16 January 2013 .


Recruiting .


Randomisation commenced on 1 January 2014 .


People are now living longer , but disability may affect the quality of those additional years of life .


We undertook a trial to assess whether case finding reduces disability among older primary care patients .


We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool ( BRIGHT ) among 60 primary care practices in New Zealand , assigning them to an intervention or control group .


Intervention practices sent a BRIGHT screening tool to older adults every birthday ; those with a score of 3 or higher were referred to regional geriatric services for assessment and , if needed , service provision .


Control practices provided usual care .


Main outcomes , assessed in blinded fashion , were residential care placement and hospitalization , and secondary outcomes were disability , assessed with Nottingham Extended Activities of Daily Living Scale ( NEADL ) , and quality of life , assessed with the World Health Organization Quality of Life scale , abbreviated version ( WHOQOL-BREF ) .


All 8,308 community-dwelling patients aged 75 years and older were approached ; 3,893 ( 47 % ) participated , of whom 3,010 ( 77 % ) completed the trial .


Their mean age was 80.3 ( SD 4.5 ) years , and 55 % were women .


Overall , 88 % of the intervention group returned a BRIGHT tool ; 549 patients were referred .


After 36 months , patients in the intervention group were more likely than those in the control group to have been placed in residential care : 8.4 % vs 6.2 % ( hazard ratio = 1.32 ; 95 % CI , 1.04-1 .68 ; P = .02 ) .


Intervention patients had smaller declines in mean scores for physical health-related quality of life ( 1.6 vs 2.9 points , P = .007 ) and psychological health-related quality of life ( 1.1 vs 2.4 points , P = .005 ) .


Hospitalization , disability , and use of services did not differ between groups , however .


Our case-finding strategy was effective in increasing identification of older adults with disability , but there was little evidence of improved outcomes .


Further research could trial stronger primary care integration strategies .


To investigate the effects of intensive atorvastatin therapy on programmed cell death 4 ( PDCD4 ) expression by CD4 + T lymphocytes in patients with unstable angina who received percutaneous coronary intervention ( PCI ) .


Patients with unstable angina were randomized to pretreatment with either an intensive dose ( 80 mg/day , n = 33 ) or a conventional dose ( 20 mg/day , n = 33 ) of atorvastatin .


Circulating CD4 + T cells were subsequently obtained prior to PCI , and also 18-24 h after PCI , using a magnetic cell sorting system .


Fluorescence-based quantitative real-time PCR was then used to measure levels of PDCD4 mRNA in the isolated CD4 + T lymphocytes , and Western blot analysis was used to detect levels of PDCD4 .


Serum levels of interleukin ( IL ) -10 and TNF - were quantified using enzyme-linked immunosorbent assays .


Of the 66 patients with unstable angina that were examined , levels of PDCD4 mRNA and protein were found to dramatically decrease in patients who received an intensive dose of atorvastatin following PCI ( p < 0.05 ) .


In contrast , serum levels of TNF - significantly increased following PCI in both the intensive dose group and the conventional dose group , with the latter being higher than the former ( p < 0.05 ) .


Serum IL-10 levels also markedly increased following PCI for the two groups .


However , higher values were associated with the intensive dose group ( p < 0.05 ) .


Intensive atorvastatin treatment reduced the post-PCI myocardial inflammatory response in patients with unstable angina , possibly by inhibiting PDCD4 expression in CD4 + T lymphocytes .


A randomized and double-blinded study design was implemented to assess the stereo-acuity in patients symmetrically implanted with four types of multifocal intraocular lenses ( MIOLs ) , compared to a monofocal lens ( control group ) .


In addition , the influence of the type of test employed for the evaluation of stereo-acuity was explored .


Six months after cataract intervention , stereo-acuity was measured with the Titmus and TNO stereotests in 143 patients implanted with one of the following MIOL lens types : hybrid spherical SN60D3 , hybrid aspheric SN6AD1 , diffractive aspheric ZMA00 and refractive spherical NXG1 .


A control group implanted with the monofocal aspheric ZA9003 ( in which stereo-acuity was measured with a near addition ) was also included in the study .


Statistically significant better stereo-acuity was found in the monofocal group with both stereotests ( except for the SN60D3 group with the Titmus test ) ( all p < 0.001 ) .


No significant differences in stereo-acuity between MIOLs were found using the Titmus test .


However , with the TNO , patients implanted with hybrid diffractive MIOLs exhibited statistically significant worse stereo-acuity than those with the refractive design ( SN60D3 , p < 0.001 ; SN6AD1 , p = 0.006 ) .


Patients implanted with MIOLs have worse stereo-acuity than those implanted with monofocal IOLs due to the decrease in retinal image contrast originating in the simultaneous presence of two images .


A wavelength-based stereotest such as the TNO induces large differences in image contrast between fellow eyes implanted with diffractive-based MIOLs , which may result in an underestimation of the real stereo-acuity of the patient .


The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia ( CLI ) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics ( e.g. , severe calcification , chronic total occlusions ) , which frequently result in poor clinical outcomes .


While infrapopliteal vessel patency directly affects pain relief and wound healing , sustained patency and extravascular care both contribute to the ultimate `` patient-centric '' outcomes of functional limb preservation , mobility and quality of life ( QoL ) .


IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion paclitaxel drug-eluting balloon ( IA-DEB ) and standard balloon angioplasty ( PTA ) in patients with Rutherford Class 4-5-6 CLI .


This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss ( LLL ) and clinically driven target lesion revascularization ( TLR ) in major amputation-free surviving patients through 12-months .


An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1 , 6 , and 12 months .


A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months .