Chronic obstructive pulmonary disease ( COPD ) is recognized as a systemic illness with significant extra-pulmonary features , such as exercise intolerance and muscle weakness .


Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD .


However , limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care .


Furthermore , it is unknown if improved exercise capacity translates into enhanced daily physical activities .


The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD .


In this randomized controlled trial situated in the primary care setting , 102 patients with mild to moderate airflow obstruction ( FEV1 50 % of predicted ) , dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group .


The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice , which includes exercise training , resistance training , breathing exercises and advises on how to increase the level of physical activity .


The control group receives usual care , i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected .


Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance .


Secondary outcomes include peripheral muscle strength , physical activity in daily life , health related quality of life , Medical Research Council ( MRC ) dyspnoea score and patients ' perceived effectiveness .


Follow-up measurement will take place at 6 months after baseline .


This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care .


The results of this trial may give a unique insight into the potential of the implementation of an easy , close-to-home rehabilitation programme .


The Netherlands National Trial Register NTR1471 .


Single-site laparoscopic surgery ( SSLS ) is still only used in limited situations to treat children with appendicitis .


Using conventional laparoscopic ( CL ) equipment to perform SSLS appendectomy is considered a valuable application in China .


This prospective randomized trial aims to evaluate the surgical outcome of SSLS and CL appendectomy using CL equipment .


Sixty patients were recruited and randomly assigned to receive SSLS or 3-port CL appendectomy between February 2011 and June 2013 .


Each case of SSLS appendectomy was performed using CL instruments .


Surgery outcomes , including operative time , conversion rates , postoperative complications , hospital stays , and hospital costs were evaluated .


Patient characteristics were similar between groups .


The SSLS using CL instruments was successful in all the 30 patients and no conversions occurred .


Mean operative time was longer in the SSLS group than the CL group ( 64.33.1 vs 53.02.9 min , respectively ; p = 0.000 ) .


Complication rates , lengths of hospital stay , and hospital costs were similar between the two groups .


The findings of this study demonstrate that using conventional instruments to perform SSLS is technically feasible and safe in children .


Although SSLS appendectomy does increase the operative time , it does not increase the complication rate and hospital cost .


Research has shown that participation in Alcoholics Anonymous ( AA ) confers significant recovery benefit to adults suffering from alcohol use disorder ( AUD ) .


Concerns persist , however , that AA may not work as well for younger adults , who tend to have shorter addiction histories , different social circumstances , and less spiritual/religious interest than adults .


Secondary data analysis of Project MATCH , using a prospective , moderated multiple mediation analysis to test and compare six previously identified mechanisms of change in younger adults ( n = 266 ) vs. adults aged 30 + ( n = 1460 ) .


Nine clinical sites within the United States .


Treatment-seeking adults ( n = 1726 ) suffering from AUD who participated in 12 weeks of outpatient treatment and completed follow-ups at 3 - , 9 - and 15-months .


AA attendance during treatment ; mediators at 9 months ; and outcomes [ percentage of days abstinent ( PDA ) and drinks per drinking day ( DDD ) ] at 15 months .


AA attendance was associated with improved drinking outcomes in both younger adults ( PDA : F ( 1 , 247 ) = 8.55 , p < 0.01 ; DDD : F ( 1 , 247 ) = 15.93 , p < 0.01 ) and adults aged 30 + ( PDA : F ( 1 , 1311 ) = 86.58 , p < 0.01 ; DDD : F ( 1 , 1311 ) = 11.96 , p < 0.01 ) .


Only two of the six hypothesized pathways ( i.e. , decreases in pro-drinking social networks , self-efficacy in social situations ) appeared to work in younger adults .


Unidentified mechanisms of behavior change that are mobilized by AA participation appear to be at work in young people .


Once identified , these mechanisms may shed new light on how exactly AA confers similar benefits for young people and , more broadly , may enhance our understanding of recovery-related change for young adults that could yield novel intervention targets .


The current study was a randomized controlled trial investigating the effect of an innovative , short-term lifestyle intervention on weight gain in female freshman college students .


Ninety-five freshmen were recruited from a large public university in the United States .


Participants completed baseline assessments and were randomized to a 5-session , 4-week intervention or wait-list control , with assessments at posttest and 3-month follow-up .


The hypothesized time by group interaction was not significant , p = .393 ; however , trends suggested that control participants maintained baseline weight , whereas intervention participants lost -2.07 kg by posttest but regained 1.05 kg at follow-up .


Significantly more intervention participants ( 47.0 % ) decreased their daily caloric intake by 200 kcal compared with control ( 31.7 % ) , p = .050 .


Brief intervention to prevent weight gain was not effective in this sample .


Future studies should investigate lengthening the intervention to enhance effectiveness and increasing recruitment to improve statistical power .


Seroma formation remains a significant problem in abdominoplasty procedures -- the cause of which remains to be elucidated .


It has been suggested that one of the causative factors for seroma formation is the use of handheld electrocautery as opposed to scalpel for abdominal flap dissection .


Prospective trial in 102 consecutive abdominoplasty patients randomised to have abdominal flap dissection with either handheld electrocautery device on ` coagulation setting ' or sharp dissection with scalpel and monopolar electrocautery forceps for haemostasis .


In all other aspects the surgical technique was identical between the two groups .


All drains were removed at 48 h , irrespective of drain volume .


Primary outcome measure is postoperative seroma formation on clinical examination , secondary outcome measures are drain volume , weight of tissue removed , effect of liposuction and patient BMI .


Both study groups were similar in demographics with no significant difference in weight of tissue excised , BMI , drain output or post operative complictions .


There was no significant difference in seroma formation rates between the handheld electrocautery group ( 17.2 % ) and the sharp dissection group ( 20.1 % ) .


Overall , the seroma rate was 18.6 % .


Liposuction to the flanks at the time of abdominoplasty was found to significantly increase the incidence of seroma , compared to patients having abdominoplasty alone .


Use of handheld electrocautery rather than scalpel for tissue dissection does not lead to increased seroma formation in abdominoplasty patients .


Concomitant liposuction at the time of abdominoplasty increases the risk of seroma formation compared to patients having abdominoplasty alone .


Preclinical evidence demonstrates that inorganic nitrite , after its in situ conversion to nitric oxide , attenuates consequent myocardial reperfusion injury .


We investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction .


Patients undergoing primary percutaneous coronary intervention ( n = 80 ) were randomized to receive intracoronary ( 10 mL ) sodium nitrite ( 1.8 mol ) or NaCl ( placebo ) before balloon inflation .


The primary end point was infarct size assessed by measuring creatine kinase release .


Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day 2 .


Baseline characteristics were similar between the groups .


No evidence of differences in creatine kinase release ( P = 0.92 ) , troponin T ( P = 0.85 ) , or cardiac MRI-assessed infarct size ( P = 0.254 ) were evident .


In contrast , there was an improvement [ corrected ] in myocardial salvage index ( P = 0.05 ) and reduction in [ corrected ] major adverse cardiac event at 1 year ( 2.6 % versus 15.8 % ; P = 0.04 ) in the nitrite group .


In a 66-patient subgroup with thrombolysis in myocardial infarction 1 flow , there was reduced serum creatine kinase ( P = 0.030 ) and a 19 % reduction in cardiac MRI-determined infarct size ( P = 0.034 ) with nitrite .


No adverse effects of nitrite were detected .


In this phase II study , intracoronary nitrite infusion did not alter infarct size , although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident .


In a subgroup of patients with thrombolysis in myocardial infarction flow 1 , nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index , indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted .


http://www.clinicaltrials.gov .


Unique identifier : NCT01584453 .


The mechanism of action of vagus nerve stimulation ( VNS ) in intractable epilepsy is not entirely clarified .


It is believed that VNS causes alterations in cytokines , which can lead to rebalancing the release of neurotoxic and neuroprotective tryptophan metabolites .


We aimed to evaluate VNS effects on tryptophan metabolites and on epileptic seizures and investigated whether the antiepileptic effectiveness correlated with changes in tryptophan metabolism .


Forty-one children with intractable epilepsy were included in a randomized , active-controlled , double-blind study .


After a baseline period of 12 weeks , all children underwent implantation of a vagus nerve stimulator and entered a blinded active-controlled phase of 20 weeks .


Half of the children received high-output ( therapeutic ) stimulation ( n = 21 ) , while the other half received low-output ( active control ) stimulation ( n = 20 ) .


Subsequently , all children received high-output stimulation for another 19 weeks ( add-on phase ) .


Tryptophan metabolites were assessed in plasma and cerebrospinal fluid ( CSF ) by use of liquid chromatography-tandem mass spectrometry ( LC-MS/MS ) and compared between high - and low-output groups and between the end of both study phases and baseline .


Seizure frequency was recorded using seizure diaries .


Mood was assessed using Profile of Mood States ( POMS ) questionnaires .


Regarding tryptophan metabolites , anthranilic acid ( AA ) levels were significantly higher at the end of the add-on phase compared with baseline ( p = 0.002 ) and correlated significantly with improvement of mood ( = -0.39 , p = 0.037 ) and seizure frequency reduction ( = -0.33 , p < 0.01 ) .


No significant changes were found between high - and low-output groups regarding seizure frequency .


Vagus nerve stimulation induces a consistent increase in AA , a neuroprotective and anticonvulsant tryptophan metabolite .


Moreover , increased AA levels are associated with improvement in mood and reduction of seizure frequency .


This study was conducted to compare the oral bioavailability of an itopride extended-release ( ER ) formulation with that of the reference immediate-release ( IR ) formulation in the fasting state .


The effect of food on the bioavailability of itopride ER was also assessed .


A single-center , open-label , randomized , multiple-dose , three-treatment , three-sequence , crossover study was performed in 24 healthy male subjects , aged 22-48 years , who randomly received one of the following treatments for 4 days in each period : itopride 150 mg ER once daily under fasting or fed conditions , or itopride 50 mg IR three times daily in the fasting state .


Steady-state pharmacokinetic parameters of itopride , including peak plasma concentration ( Cmax ) and area under the plasma concentration versus time curve over 24 hours after dosing ( AUC ( 0-24h ) ) , were determined by noncompartmental analysis .


The geometric mean ratio of the pharmacokinetic parameters was derived using an analysis of variance model .


A total of 24 healthy Korean subjects participated , 23 of whom completed the study .


The geometric mean ratio and its 90 % confidence interval of once-daily ER itopride versus IR itopride three times a day for AUC ( 0-24h ) were contained within the conventional bioequivalence range of 0.80-1 .25 ( 0.94 [ 0.88-1 .01 ] ) , although Cmax was reached more slowly and was lower for itopride ER than for the IR formulation .


Food delayed the time taken to reach Cmax for itopride ER , but AUC ( 0-24h ) was not affected .


There were no serious adverse events and both formulations were generally well tolerated .


At steady state , once-daily itopride ER at 150 mg has a bioavailability comparable with that of itopride IR at 50 mg given three times a day under fasting conditions .


Food delayed the absorption of itopride ER , with no marked change in its oral bioavailability .


Mechanical pleurodesis is widely used to treat primary spontaneous pneumothorax to decrease postoperative recurrence after thoracoscopic bullectomy , but it is unclear whether it actually reduces primary spontaneous pneumothorax recurrence .


We aimed to investigate the effectiveness of mechanical pleurodesis after thoracoscopic treatment of primary spontaneous pneumothorax .


In our parallel-group , prospective , randomized , controlled trail at 2 hospitals in China , 289 patients were enrolled from January 2010 to January 2013 .


Patients were randomly assigned ( 1:1 ) to receive thoracoscopic wedge resection only ( WR group ) or thoracoscopic wedge resection and mechanical pleurodesis ( WR+MP group ) .


This trial is registered with ClinicalTrial.gov ( NCT01463553 ) .


Intraoperative bleeding and postoperative pleural drainage were significantly lower in the thoracoscopic WR only group .


Postoperative recurrence rate did not significantly differ between groups ( log-rank test p = 0.791 ; Breslow test p = 0.722 ) .


In the thoracoscopic WR only group , no recurrences were found when bullae were isolated or limited ; recurrence was 7.5 % with the presence of multiple bullae .


Younger patients had an increased risk of recurrence ( relative risk 3.015 ; 95 % confidence interval 1.092 to 8.324 ) .


Thoracoscopic mechanical pleurodesis did not significantly decrease primary spontaneous pneumothorax recurrence compared with simple wedge resection , but intraoperative bleeding and postoperative pleural drainage rates were higher .


Younger age increases the risk of recurrence .


Due to time constraints that limit physician 's ability to deliver detailed contraception counseling , patients increasingly require supplemental education opportunities .


Applications for smartphones and tablets are being designed to educate patients about contraceptive methods and simplify communication between patient and provider .


We designed a mobile application entitled Plan A Birth Control to provide targeted information about the 10 most common , nonpermanent contraceptive methods with emphasis on long-acting reversible methods .


We developed a mobile application designed to provide tailored information about the 10 most common nonpermanent contraceptive methods .


After pilot testing with 40 volunteers from the clinic , 120 participants were recruited for a randomized controlled trial .


( ClinicalTrials.gov identifier : NCT02234271 ) Participants were assigned by simple randomization to contraception counseling via tablet or health educator .


We compared participants ' contraceptive choice between the 2 groups .


Secondary outcomes included knowledge of the method of choice and satisfaction with counseling .


Of the 120 participants in the primary study , 65 chose long-acting reversible methods .


The uptake of long-acting reversible contraceptives was similar between the groups ( 34 received health educator counseling and 31 received mobile application counseling ) .


Both groups were demographically similar in age and educational status .


Knowledge of long-acting methods did not differ significantly between the groups ( P = .30 ) .


Results from our study suggest that Plan A Birth Control did not adversely affect highly effective birth control uptake in our study population .


This can save time for physicians and health educators if used as an adjunct to contraception counseling in waiting room settings .


Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia .


The efficacy and safety of this recommendation , however , have not been tested in the hospital setting .


In this open-label , randomized controlled trial , 206 general medicine and surgery patients with type 2 diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin ( n = 106 ) at bedtime for blood glucose ( BG ) > 7.8 mmol/L or no supplemental insulin ( n = 100 ) except for BG > 19.4 mmol/L .


Point-of-care testing was performed before meals , at bedtime , and at 3:00 a.m.


The primary outcome was the difference in fasting BG .


In addition to the intention-to-treat analysis , an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between 7.8 and 19.4 mmol/L .


There were no differences in mean fasting BG for the intention-to-treat ( 8.8 2.4 vs. 8.6 2.2 mmol/L , P = 0.76 ) and as-treated ( 8.9 2.4 vs. 8.8 2.4 mmol/L , P = 0.92 ) analyses .


Only 66 % of patients in the supplement and 8 % in the no supplement groups received bedtime supplemental insulin .


Hypoglycemia ( BG < 3.9 mmol/L ) did not differ between groups for either the intention-to-treat ( 30 % vs. 26 % , P = 0.50 ) or the as-treated ( 4 % vs. 8 % , P = 0.37 ) analysis .


The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control .


We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type 2 diabetes .


The method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration .


The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction ( ED ) for intermediate-term period .


This multicenter , randomized , double-blind clinical trial included 346 ED patients ( placebo , udenafil 50mg , udenafil 75mg ) .


Subjects were treated with each medication once daily for 24 weeks .


Subjects were asked to complete the International Index of Erectile Function ( IIEF ) - erectile function ( EF ) domain at baseline , 12 weeks , and 24 weeks and the development of adverse drug reactions ( ADRs ) was inspected .


Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks .


When patients were divided according to the severity of baseline EF score , significant improvement was observed only with udenafil 75mg regardless of the degree of ED .


At 24 weeks , the proportions of patients who reported a return to normal EF ( IIEF-EF over 26 ) were 39.1 % for udenafil 50mg and 47.0 % for udenafil 75mg .


In terms of safety , ADRs were observed in 6.1 % , 12.9 % , and 17.9 % for placebo , udenafil 50mg , and 75mg , respectively .


Although a statistically higher rate of ADRs was observed in the udenafil 75mg group ( P = 0.024 ) , the majority were mild and recovered without treatment .


Once-daily administration of udenafil 50mg and 75mg for 24 weeks resulted in improvement of EF .


In particular , udenafil 75mg improves EF regardless of the baseline degree of ED .


Immunization of healthy volunteers by bites from Plasmodium falciparum-infected mosquitoes during chloroquine chemoprophylaxis ( hereafter , chemoprophylaxis and sporozoites [ CPS ] immunization ) induces sterile protection against malaria .


CPS-induced protection is mediated by immunity against pre-erythrocytic stages , presumably at least partially by cytotoxic cellular responses .


We therefore aimed to investigate the association of CPS-induced cytotoxic T-cell markers with protection .


In a double-blind randomized controlled trial , we performed dose titration of CPS immunization followed by homologous challenge infection in 29 subjects .


Immune responses were assessed by in vitro restimulation of peripheral blood mononuclear cells and flow cytometry .


Dose-dependent complete protection was obtained in 4 of 5 volunteers after immunization with bites from 45 P. falciparum-infected mosquitoes , in 8 of 9 volunteers with bites from 30 , and in 5 of 10 volunteers with bites from 15 ( odds ratio [ OR ] , 5.0 ; 95 % confidence interval [ CI ] , 1.5-17 ) .


Completely protected subjects had significantly higher proportions of CD4 T cells expressing the degranulation marker CD107a ( OR , 8.4 ; 95 % CI , 1.5-123 ; P = .011 ) and CD8 cells producing granzyme B ( OR , 11 ; 95 % CI , 1.9-212 ; P = .004 ) after P. falciparum restimulation .


These data underline the efficiency of CPS immunization to induce sterile protection and support a possible role for cytotoxic CD4 and CD8 T-cell responses in pre-erythrocytic immunity .


NCT01218893 .


We compare the safety and efficacy of ecallantide with placebo in subjects undergoing assessment for acute angiotensin-converting enzyme inhibitor-induced angioedema ( ACEIA ) in an emergency department ( ED ) .


This was a multicenter , phase 2 , double-blind study with subjects randomized to receive a single subcutaneous dose of ecallantide ( 10 , 30 , or 60 mg ) or placebo plus physician-directed conventional therapy .


The primary endpoint was defined as meeting predetermined discharge eligibility criteria within 6 hours of study drug administration .


Discharge criteria included improvement of edema , stable vital signs , absence of stridor , absence of dyspnea or use of accessory muscles during respiration , absence of drooling , and ability to drink without difficulty .


An interim analysis showed that a high percentage of subjects met the primary endpoint , and the study was halted .


Overall , 79 subjects were randomized and 76 had data for analysis .


Most had mild ( 45 % ) or moderate ( 42 % ) ACEIA .


The discharge eligibility endpoint was met by 72 % of the placebo group and 85 % , 89 % , and 89 % of the ecallantide 10 - , 30 - , and 60-mg groups , respectively .


This difference in meeting discharge eligibility endpoint criteria between treatment groups was not statistically significant .


The incidence of treatment-emergent adverse events was similar between placebo and active-treatment groups .


The addition of ecallantide to standard therapy does not appear to improve angioedema compared with placebo in ED patients with ACEIA .


Our data suggest that most ED patients presenting with mild to moderate ACEIA are likely to meet our discharge eligibility criteria within 6 hours of treatment , regardless of intervention .


Further studies to assess the utility of ecallantide in patients with more severe angioedema may be useful .


No new safety signals related to ecallantide administration were identified .


To determine the effects of dietary-induced weight loss ( D ) and weight loss plus exercise ( D + E ) compared to exercise alone ( E ) on bone mineral density ( BMD ) in older adults with knee osteoarthritis ( OA ) .


Data come from 284 older ( 66.0 6.2 years ) , overweight/obese ( body mass index ( BMI ) 33.4 3.7 kg/m2 ) , adults with knee OA enrolled in the Intensive Diet and Exercise for Arthritis ( IDEA ) study .


Participants were randomized to 18 months of walking and strength training ( E ; n = 95 ) , dietary-induced weight loss targeting 10 % of baseline weight ( D ; n = 88 ) or a combination of the two ( D + E ; n = 101 ) .


Body weight and composition ( DXA ) , regional BMD , were obtained at baseline and 18 months .


E , D , and D + E groups lost 1.3 4.5 kg , 9.1 8.6 kg and 10.4 8.0 kg , respectively ( P < 0.01 ) .


Significant treatment effects were observed for BMD in both hip and femoral neck regions , with the D and D + E groups showing similar relative losses compared to E ( both P < 0.01 ) .


Despite reduced BMD , fewer overall participants had T-scores indicative of osteoporosis after intervention ( 9 at 18 months vs 10 at baseline ) .


Within the D and D + E groups , changes in hip and femoral neck , but not spine , BMD correlated positively with changes in body weight ( r = 0.21 and 0.54 respectively , both P 0.01 ) .


Weight loss via an intensive dietary intervention , with or without exercise , results in bone loss at the hip and femoral neck in overweight and obese , older adults with OA .


Although the exercise intervention did not attenuate weight loss-associated reductions in BMD , classification of osteoporosis and osteopenia remained unchanged .


NCT00381290 .


To evaluate the feasibility of a low-dose contrast medium protocol for 64-detector row computed tomography angiography ( CTA ) of the neck using a low-tube-voltage/high-tube-current setting .


A phantom study was performed using 64-detector row spiral CT at multiple tube voltage and current settings .


Iodine contrast medium attenuation curves were acquired by processing and used to select the best contrast medium-to-noise ratio ( CNR ) .


A prospective clinical study was then performed on 84 patients requiring neck CTA .


Patients were randomly divided into two groups of 42 .


Group A was examined using the conventional imaging protocol ( 120 kV , 400 mAs ) and group B was examined at 80 kV and 600 mAs along with a 50 % reduction in contrast medium dose .


The CT dose index-volume ( CTDI ( vol ) ) , background noise ( BN ) , and CNR were measured and statistically analysed .


Various image quality criteria were evaluated by two senior radiologists using a qualitative five-point scale .


Comparing group B with A , CTDIvol decreased by 54 % ( B : 27.48 mGy , A : 59.11 mGy ) , however , the CNR increased by 50 % .


The mean attenuation , which was caused by venous streak artefacts , was significantly lower in group B than A. Qualitative image analysis found that all criteria were significantly better for group B than A.


At 64-detector row spiral CT , the low-tube-voltage/high-tube-current with low-dose contrast medium protocol was superior to the conventional protocol regarding radiation dose , venous streak artefacts , and image quality , and is feasible for CTA of the neck .


Dyslipidemia is highly prevalent among patients with HIV infection and contributes to an increased risk of cardiovascular disease .


We investigated the influence of a frequently used statin , atorvastatin , on the pharmacokinetics of the HIV-integrase inhibitor raltegravir and vice versa .


Open-label , crossover 3-period phase I trial in 24 healthy volunteers .


Subjects took raltegravir 400 mg two times a day for 7 days , atorvastatin 20 mg once a day for 7 days , and the combination of atorvastatin 20 mg once a day + raltegravir 400 mg two times a day for 7 days with 2-week washout periods in between .


Intensive steady-state 12 - and 24-hour pharmacokinetic blood sampling was performed .


Geometric mean ratios of the test treatment ( combination raltegravir + atorvastatin ) versus the reference treatment ( raltegravir or atorvastatin alone ) and 90 % confidence intervals were calculated for the area under the plasma concentration-time curve ( AUC ) .


Fasting lipid profiles were obtained to assess short-term lipid-lowering effect of atorvastatin with or without concomitant raltegravir use .


Twenty-four healthy volunteers ( 11 males ) were enrolled .


All but 1 subject completed the trial , and no serious adverse events were reported .


Geometric mean ratios ( 90 % confidence interval ) were 1.01 ( 0.68-1 .51 ) for raltegravir AUC ( 0-12h ) and 1.00 ( 0.90-1 .11 ) for atorvastatin AUC ( 0-24h ) .


The AUC ( 0-24h ) metabolite-to-parent ratio for atorvastatin lactone , ortho-hydroxy , and para-hydroxy atorvastatin did not change during concomitant raltegravir use .


The effect of atorvastatin on low-density lipoprotein cholesterol was not significantly different when combined with raltegravir versus atorvastatin alone ( P = 0.638 ) .


Atorvastatin 20 mg has no clinically relevant effect on the pharmacokinetics of raltegravir and vice versa .


The combination was well tolerated and can be administered without dose adjustments .


To compare the role of topically applied serum therapy with preservative-free artificial tear ( AT ) drops in patients with moderate to severe dry eye in Hansen 's disease along with change in tear protein profile .


144 consecutive patients were randomly divided into three groups .


After a baseline examination of clinical parameters , each of the patients received designated modality of topical therapy six times a day for 6weeks .


Post-treatment documentation of clinical parameters was done at 6weeks , and then at 12weeks after discontinuation of topical therapy .


Analysis of three tear proteins using gel electrophoresis ( sodium dodecyl sulfate polyacrylamide gel electrophoresis ) was done at baseline , at the first and second post-treatment visits .


In the cord blood serum ( CBS ) group , except for McMonnies score and staining score , all other clinical parameters showed continued improvement in the first and second post-treatment analyses .


In the autologous serum ( ALS ) group , all the clinical parameters except Schirmer 's I showed significant improvement in the first post-treatment analysis .


This was sustained at a significant level in the second analysis except for tear film break-up time ( TBUT ) and conjunctival impression cytology grading .


In the AT group , all the parameters improved at a non-significant level except for TBUT in the first analysis .


In the next analysis , apart from McMonnies score and TBUT , other clinical parameters did not improve .


In the ALS and CBS groups , tear lysozyme , lactoferrin levels improved in both post-treatment measurements ( statistically insignificant ) .


Total tear protein continued to increase at statistically significant levels in the first and second post-treatment analyses in the CBS group and at a statistically insignificant level in the ALS group .


In the AT group , the three tear proteins continued to decrease in both the analyses .


In moderate to severe dry eye in Hansen 's disease , serum therapy in comparison with AT drops , improves clinical parameters and causes betterment in tear protein profile .


CTRI/2013/07 / 003802 .


Heart failure ( HF ) has a major effect on patients ' health status , including their symptom burden , functional status , and health-related quality of life .


To determine the effectiveness of a collaborative care patient-centered disease management ( PCDM ) intervention to improve the health status of patients with HF .


The Patient-Centered Disease Management ( PCDM ) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF .


A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire ( KCCQ ) overall summary score of less than 60 ( heavy symptom burden and impaired functional status and quality of life ) were enrolled between May 2009 and June 2011 .


The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator , cardiologist , psychiatrist , and primary care physician ; home telemonitoring and patient self-management support ; and screening and treatment for comorbid depression .


The primary outcome was change in the KCCQ overall summary score at 1 year ( a 5-point change is clinically significant ) .


Mortality , hospitalization , and depressive symptoms ( Patient Health Questionnaire 9 ) were secondary outcomes .


There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention ( n = 187 ) vs usual care ( n = 197 ) ; baseline mean KCCQ overall summary scores were 37.9 vs 36.9 ( P = .48 ) .


There was significant improvement in the KCCQ overall summary scores in both groups after 1 year ( mean change , 13.5 points in each group ) , with no significant difference between groups ( P = .97 ) .


The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month , 6-month , and 12-month data ( P = .74 ) .


Among secondary outcomes , there were significantly fewer deaths at 1 year in the intervention arm ( 8 of 187 [ 4.3 % ] ) than in the usual care arm ( 19 of 197 [ 9.6 % ] ) ( P = .04 ) .


Among those who screened positive for depression , there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm ( 2.1 points lower , P = .01 ) .


There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm ( 29.4 % vs 29.9 % , P = .87 ) .


This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care .


clinicaltrials.gov Identifier : NCT00461513 .


Low back pain is highly prevalent in patients with HTLV-1 .


The effects of physical activity on this condition are not known , but postural misalignment and motor deficits are frequently present .


To assess the effect of Pilates exercises on chronic low back pain in these patients , and its impact on quality of life .


A randomized crossover clinical trial was conducted , involving 22 patients from a reference center in Salvador , Bahia , Brazil .


The VAS was used to evaluate the effect of Pilates on pain intensity and the SF-36 to assess its impact on quality of life .


Our results provide evidence of positive effects on pain intensity and almost all domains of quality of life when patients followed the Pilates exercise program described .


The Pilates method may be a useful tool in alleviating the symptoms of low back pain , and had a significant impact on quality of life in this sample of patients .


Communication is essential for triage , but intervention trials to improve it are scarce .


Referral Writer ( RW ) , a referral letter software program , enables documentation of clinical data and extracts relevant patient details from clinical software .


To evaluate whether specialists are more confident about scheduling appointments when they receive more information in referral letters .


Single-blind , parallel-groups , controlled design with a 1:1 randomisation .


Australian GPs watched video vignettes virtually .


GPs wrote referral letters after watching vignettes of patients with cancer symptoms .


Letter content was scored against a benchmark .


The proportions of referral letters triagable by a specialist with confidence , and in which the specialist was confident the patient had potentially life-limiting pathology were determined .


Categorical outcomes were tested with ( 2 ) and continuous outcomes with t-tests .


A random-effects logistic model assessed the influence of group randomisation ( RW versus control ) , GP demographics , clinical specialty , and specialist referral assessor on specialist confidence in the information provided .


The intervention ( RW ) group referred more patients and scored significantly higher on information relayed ( mean difference 21.6 [ 95 % confidence intervals { CI } = 20.1 to 23.2 ] ) .


There was no difference in the proportion of letters for which specialists were confident they had sufficient information for appointment scheduling ( RW 77.7 % versus control 80.6 % , P = 0.16 ) .


In the logistic model , limited agreement among specialists contributed substantially to the observed differences in appointment scheduling ( P = 35 % [ 95 % CI 16 % to 59 % ] ) .


In isolation , referral letter templates are unlikely to improve the scheduling of specialist appointments , even when more information is relayed .


The clinical results of restoring defective teeth with two types of glass fiber prothetic systems is investigated to acquire clinical experience for further application of glass fiber posts with independent intellectual property rights .


A total of 120 out-patients with restored defective teeth were selected from the Department of Stomatology , Beijing Xuanwu Hospital of Traditional Chinese Medicine and Peking University School and Hospital of Stomatology and randomly divided into two groups .


OUYA FIBER posts and Tenax Fiber White posts were used to restore defective teeth in the experimental group and the control group , respectively .


Clinical evaluation was conducted one week and three months post-restoration .


Both clinical satisfactory rates of OUYA FIBER posts and Tenax Fiber White posts were higher than 98 % one week post-restoration and higher than 96 % three months post-restoration .


No significant differences were observed between the clinical results of restoring defective teeth with the two types of fiber posts .


Throughout the healing process , no root canal fracture or marginal staining were observed .


OUYA FIBER post and Tenax Fiber White post showed similar clinical outcomes during the period of observation in this study .


However , the long-term effects should be observed in future studies .


Delayed gastric emptying ( DGE ) is a major problem after pancreatoduodenectomy ( PD ) .


A recent multicentre randomized trial reported no difference in gastric emptying rates between retrocolic and antecolic reconstruction routes .


The present study looked at quality of life with these two approaches and the correlation with gastric emptying .


This was a substudy of patients completing a panel of quality-of-life questionnaires within a randomized trial comparing retrocolic and antecolic gastroenteric reconstruction after PD .


Gastric emptying was assessed by scintigraphy 1week after surgery .


Quality of life was measured with the EuroQoL - 5D questionnaire ( EQ-5D ) , the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ( QLQ-C30 ) with its pancreatic cancer module ( PAN26 ) , and the Gastrointestinal Quality of Life Index ( GIQLI ) .


There were 38 patients in the retrocolic and 35 in the antecolic group .


Baseline characteristics and clinical outcomes were similar in the two groups .


Median time to half-emptying of stomach content after surgery was 145 and 64min in the retrocolic and antecolic group respectively ( P = 0.189 ) .


Median percentages of residual activity after 2h were 64 and 28 per cent respectively ( P = 0.213 ) .


Quality of life did not differ at any time point between the groups .


At 2weeks after surgery , patients with DGE had significantly worse outcomes on two EQ-5D domains , ten QLQ-C30 / PAN26 subscales , and two GIQLI subscales and total score .


Effect sizes were moderate to large .


The route of gastroenteric reconstruction after PD does not influence either gastric emptying at scintigraphy or quality of life .


The impact of DGE on quality of life is clinically significant .


Registration number NTR1697 ( www.trialregister.nl ) .


Switches between anti-tumor necrosis factor agents in the treatment of Crohn 's disease ( CD ) occur in case of treatment failure , intolerance , or patient preference .


No data are currently available on the usefulness of a second infliximab treatment after earlier discontinuation and previous switch to an alternative anti-tumor necrosis factor agent .


In this study , we evaluated the clinical benefit of infliximab retreatment in patients with CD after sequential use of both infliximab and adalimumab .


Twenty-nine patients with CD who had received earlier treatments with sequential infliximab and adalimumab and were then restarted on infliximab were retrieved from a multicenter registry designed for the follow-up of adalimumab treatment for CD .


Short-term and sustained effects of infliximab retreatment were evaluated retrospectively by reviewing clinical records .


Follow-up was 18 months for all patients .


In 13/29 ( 45 % ) patients , infliximab was reintroduced at intensified dosing schedule ( > 5 mg/kg or < 8 wk ) for 23/29 ( 79 % ) of patients similar to the schedule who were on at time of previous discontinuation .


During the second infliximab treatment course , dosing was further intensified in 11 out of 29 ( 38 % ) patients .


After 18 months 18/29 ( 62 % ) , patients were still on continued therapy of their second infliximab treatment .


Infliximab was discontinued ( after a median of 7 mo ) in 11 out of 29 patients for loss of response ( n = 7 [ 24 % ] ) , intolerance ( n = 3 [ 10 % ] ) , or non-compliance ( n = 1 [ 3 % ] ) .


Use of induction schedule or concomitant immunomodulators were not significantly associated with treatment benefit .


The majority of patients with CD benefit from a second treatment with infliximab after previous treatment with infliximab and adalimumab , which offer a meaningful therapeutic option in often highly refractory patients .


To evaluate the efficacy and safety of Yindan Xinnaotong Soft Capsule ( YXSC ) on cerebral infarction ( CI ) reconvalescents of static blood blocking collaterals syndrome ( SBBCS ) .


Totally 118 CI reconvalescents of SBBCS were randomly assigned to the test group ( treated by YXSC ) and the control group [ treated by Naoxintong Capsule ( NC ) ] , 59 in each group .


The therapeutic course for all was 12 weeks .


Changes of National Institute of Health Stroke Scale ( NIHSS ) , Barthel Index ( BI ) , modified Rankin Scale ( mRS ) , Chinese medical syndrome scores , and serum lipid indices were observed in the two groups .


Compared with the control group , the patient proportion of improving activities of daily life by more than or equal to 75 score was elevated ( 80.7 % vs 62.5 % ; P < 0.05 ) .


Compared with before treatment in the same group , the NIHSS score decreased at post-treatment 4 , 8 , and 12 weeks in the two groups ( P < 0.05 ) .


The patient proportion of dropped NIHSS score by more than or equal to 5 score was lowered ( 80.7 % vs 57.14 % ) , and the total effective rate of improving Chinese medical syndromes was superior in the test group after 12-week treatment ( 89.47 % vs 71.43 % , all P < 0.05 ) .


After 12-week treatment there was no statistical difference in the patient proportion of lowering mRS lower than or equal to 2 or blood lipids between the two groups ( P > 0.05 ) .


YXSC showed certain effect in improving activities of daily life , attenuating the neurological impairment , and elevating the total effective rate of improving Chinese medical syndromes in CI patients in the recovery stage .


Compare relapse clinical severity , post-relapse residual disability , and the probability of confirmed complete recovery from relapse between patients who relapsed during natalizumab ( n = 183/627 [ 29 % ] ) and placebo ( n = 176/315 [ 56 % ] ) treatments in the AFFIRM trial .


In this post-hoc analysis , relapse clinical severity and residual disability were defined by change in Expanded Disability Status Scale ( EDSS ) score occurring between pre-relapse and at-relapse assessment and between pre-relapse and post-relapse assessment , respectively .


Patients were considered completely recovered from relapse when their post-relapse EDSS score was less than or equal to their pre-relapse EDSS score , and this was maintained for 12 or 24 weeks .


At relapse , an increase in EDSS score of 0.5 points occurred in 71 % of natalizumab and 84 % of placebo patients ( P = 0.0088 ) ; an increase of 1.0 point occurred in 49 % of natalizumab and 61 % of placebo patients ( P = 0.0349 ) ( mean increase in EDSS at relapse : natalizumab = 0.77 ; placebo = 1.09 ; P = 0.0044 ) .


After relapse , residual disability of 0.5 EDSS points remained in 31 % of natalizumab and 45 % of placebo patients ( P = 0.0136 ) ( mean post-relapse residual EDSS increase : natalizumab = 0.06 ; placebo = 0.28 ; P = 0.0170 ) .


In patients with an increase in EDSS of 0.5 or 1.0 during relapse , natalizumab increased the probability of 12-week confirmed complete recovery from relapse by 55 % ( hazard ratio [ HR ] = 1.554 ; P = 0.0161 ) and 67 % ( HR = 1.673 ; P = 0.0319 ) compared to placebo , respectively .


In AFFIRM , natalizumab treatment decreased the clinical severity of relapses and improved recovery from disability induced by relapses .


These beneficial effects would limit the step-wise accumulation of disability .


Reduction of infarct size by ischemic postconditioning ( IPost ) has been reported in smaller proof-of-concept clinical studies , but has not been confirmed in other smaller studies .


The principle needs to be evaluated in larger groups of ST-elevation myocardial infarction ( STEMI ) patients before being implemented in clinical practice .


This study assessed the effect of ischemic postcoditioning ( IPost ) on infarct size in patients with STEMI treated by primary percutaneous coronary intervention ( PCI ) .


Patients with first-time STEMI , < 6 hours from symptom onset , referred to primary PCI were randomized to IPost or control groups .


IPost was administered by 4 cycles of 1-minute reocclusion and 1-minute reperfusion , starting 1 minute after opening , followed by stenting .


In the control group , stenting was performed immediately after reperfusion .


The primary endpoint was infarct size measured by cardiac magnetic resonance after 4 months .


A total of 272 patients were randomized .


Infarct size ( percent of left ventricular mass ) after 4 months ( median values and interquartile range ) was 14.4 % ( 7.7 , 24.6 ) and 13.5 % ( 8.1 , 19.3 ) in the control group and IPost group , respectively ( P = 0.18 ) .


No significant impact of IPost was found when controlling for baseline risk factors of infarct size in a multivariate linear regression model ( P = 0.16 ) .


The effects of IPost on secondary endpoints , including markers of necrosis , myocardial salvage , and ejection fraction , as well as adverse cardiac events during follow-up , were consistently neutral .


In contrast to several smaller trials reported previously , we found no significant effects of IPost on infarct size or secondary study outcomes .


http://www.clinicaltrials.gov Unique identifier : NCT.No.PO1506 .


The present study aimed at investigating the effects of Lactobacillus casei 01 supplementation on symptoms and inflammatory biomarkers of rheumatoid arthritis ( RA ) in women .


In this randomized double-blind clinical trial , female patients with established RA for more than 1 year , 20-80 years of age and body mass index ( BMI ) lower than 40 , who followed stable medication for 3 months prior to the supplementation , were randomly allocated to receive either one capsule containing 10 ( 8 ) colony forming units ( CFU ) of L. casei 01 , or a placebo for 8 weeks ; allocation was stratified by BMI and menopausal status .


Disease activity score-28 ( DAS28 ) was calculated , European League Against Rheumatism ( EULAR ) response was evaluated and the cytokines , interleukin ( IL ) -1 , IL-6 , IL-10 , IL-12 and tumor necrosis factor ( TNF ) - were measured .


Thirty patients were recruited in each group ; 22 and 24 patients were analyzed in the probiotic and placebo groups , respectively .


L. casei 01 supplementation decreased serum high-sensitivity C-reactive protein ( hs-CRP ) levels , tender and swollen joint counts , global health ( GH ) score and DAS28 ( P < 0.05 ) .


More patients in the L. casei 01 group had moderate response to the treatment , based on the EULAR criteria , at the end of the study ( P < 0.01 ) .


At the end of the study , a significant difference was observed between the two groups for IL-10 , IL-12 and TNF - changes through the study course ( P < 0.05 ) , in favor of the probiotic group .


No adverse effects were reported for the intervention .


Probiotic supplementation may be an appropriate adjunct therapy for RA patients and help alleviate symptoms and improve inflammatory cytokines .


In-home iron fortification for infants in developing countries is recommended for control of anaemia , but low absorption typically results in > 80 % of the iron passing into the colon .


Iron is essential for growth and virulence of many pathogenic enterobacteria .


We determined the effect of high and low dose in-home iron fortification on the infant gut microbiome and intestinal inflammation .


We performed two double-blind randomised controlled trials in 6-month-old Kenyan infants ( n = 115 ) consuming home-fortified maize porridge daily for 4 months .


In the first , infants received a micronutrient powder ( MNP ) containing 2.5 mg iron as NaFeEDTA or the MNP without iron .


In the second , they received a different MNP containing 12.5 mg iron as ferrous fumarate or the MNP without the iron .


The primary outcome was gut microbiome composition analysed by 16S pyrosequencing and targeted real-time PCR ( qPCR ) .


Secondary outcomes included faecal calprotectin ( marker of intestinal inflammation ) and incidence of diarrhoea .


We analysed the trials separately and combined .


At baseline , 63 % of the total microbial 16S rRNA could be assigned to Bifidobacteriaceae but there were high prevalences of pathogens , including Salmonella Clostridium difficile , Clostridium perfringens , and pathogenic Escherichia coli .


Using pyrosequencing , + FeMNPs increased enterobacteria , particularly Escherichia/Shigella ( p = 0.048 ) , the enterobacteria/bifidobacteria ratio ( p = 0.020 ) , and Clostridium ( p = 0.030 ) .


Most of these effects were confirmed using qPCR ; for example , + FeMNPs increased pathogenic E. coli strains ( p = 0.029 ) .


+ FeMNPs also increased faecal calprotectin ( p = 0.002 ) .


During the trial , 27.3 % of infants in +12.5 mgFeMNP required treatment for diarrhoea versus 8.3 % in -12.5 mgFeMNP ( p = 0.092 ) .


There were no study-related serious adverse events in either group .


In this setting , provision of iron-containing MNPs to weaning infants adversely affects the gut microbiome , increasing pathogen abundance and causing intestinal inflammation .


NCT01111864 .


The control of labor pain and the prevention of suffering are major concerns of clinicians and their patients .


The aim of this study was to evaluate the effect of music on labor pain and anxiety , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement in primiparous women .


Overall , 156 primiparous women who expected vaginal delivery were recruited and randomly assigned to a music group ( n = 77 ) or a control group ( n = 79 ) .


Women in the music group listened to music during labor .


Pain intensity and anxiety level were measured using a visual analogue scale ( 0-10 cm ) .


The two groups were compared in terms of pain severity , anxiety level , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement .


Mothers in the music therapy group had a lower level of pain and anxiety compared with those in the control group at all stages of labor ( p < 0.001 ) .


A signicant difference was observed between the two groups in terms of maternal hemodynamics and fetal heart rate after intervention ( p < 0.01 ) .


Postpartum analgesic requirement significantly decreased in the music therapy group ( p < 0.01 ) .


Listening to music during labor has a positive impact on labor pain and anxiety , maternal-fetal parameters and analgesic requirement .


The aim of the study was to determine native coronary artery patency 1 year after coronary artery bypass grafting and to identify clinical and angiographic predictors for the development of a chronic total occlusion ( CTO ) .


In contrast to the large body of information regarding graft patency , data regarding atherosclerosis progression and vessel patency in surgically bypassed native coronary arteries arelessclear .


Of the 440 patients who underwent 1-year follow-up angiography as part of the multicenter RAPS ( Radial Artery Patency Study ) , included in our study were 388 patients ( 88 % ) for whom angiograms were available for review .


Angiograms were reviewed for native coronary artery patency in an independent blinded manner .


On the pre-operative angiogram , CTO of at least 1 native coronary vessel was demonstrated in240 patients ( 61.9 % ) having 305 occluded vessels .


At 1 year after coronary artery bypass grafting , atleast 1 new native coronary artery CTO occurred in 169 patients ( 43.6 % ) .


In 7.5 % of patients , the native artery and the graft supplying that territory were both occluded .


A new CTO was almost 5 times more likely to occur in coronary vessels with a pre-operative proximal stenosis > 90 % compared with vessels with proximal stenosis < 90 % ( 45.5 % vs. 9.5 % , respectively , p < 0.001 ) .


Patients with a new CTO had significantly more baseline Canadian Cardiovascular Society class 4 angina compared with patients without a new CTO .


A new CTO was less likely to occur in the left anterior descending artery ( 18.4 % ) , supplied by the left internal thoracic artery .


When comparing radial artery and saphenous veingrafts , neither the type of graft nor graft patency had any association with native coronary artery occlusion .


CTO of surgically bypassed coronary arteries 1 year after coronary artery bypass grafting is extremely common .


It is unclear whether using fetal electrocardiographic ( ECG ) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes .


We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to `` open '' or `` masked '' monitoring with fetal ST-segment analysis .


The masked system functioned as a normal fetal heart-rate monitor .


The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected .


The primary outcome was a composite of intrapartum fetal death , neonatal death , an Apgar score of 3 or less at 5 minutes , neonatal seizure , an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more , intubation for ventilation at delivery , or neonatal encephalopathy .


A total of 11,108 patients underwent randomization ; 5532 were assigned to the open group , and 5576 to the masked group .


The primary outcome occurred in 52 fetuses or neonates of women in the open group ( 0.9 % ) and 40 fetuses or neonates of women in the masked group ( 0.7 % ) ( relative risk , 1.31 ; 95 % confidence interval , 0.87 to 1.98 ; P = 0.20 ) .


Among the individual components of the primary outcome , only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group ( 0.3 % vs. 0.1 % , P = 0.02 ) .


There were no significant between-group differences in the rate of cesarean delivery ( 16.9 % and 16.2 % , respectively ; P = 0.30 ) or any operative delivery ( 22.8 % and 22.0 % , respectively ; P = 0.31 ) .


Adverse events were rare and occurred with similar frequency in the two groups .


Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates .


( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical ; ClinicalTrials.gov number , NCT01131260 . )


To compare the therapeutic effects of arthroscopy and manipulation of Traditional Chinese medicine ( TCM ) in the treatment of patellofemoral joint disease .


The patients met with the criteria of patellofemoral joint disease were divided into manipulation of TCM group and arthroscopy group randomly , 31 patients in each group .


There were 31 patients in manipulation of TCM group , including 4 males and 27 females , with an average age of ( 52.83 + / - 5.79 ) years old ; and the patients were treated with manipulation .


There were 31 patients in arthroscopy group , including 8 males and 23 females , with an average age of ( 54.14 + / - 6.12 ) years old ; the patients were treated with arthroscopy .


The HSS knee joint score , fitness angle of patellofemoral joint and lateral angle of patellofemoral joint in X-ray were compared in each group and between the two groups before and after treatment respectively .


The two therapeutics had equally efficacious in which improved HSS score significantly .


After treatment , the HSS scores in manipulation of TCM group and arthroscopy group were 94.80 + / - 7.26 and 88.65 + / - 5.79 separately , the score in manipulation of TCM group was higher than that of arthroscopy group .


Comparing with the arthroscopy group , lateral angle of patellofemoral joint with weight-hearing position were improved significantly in manipulation of TCM group .


Arthroscopy and manipulation of TCM have equally efficacious in the treatment of patellofemoral joint disease , but manipulation has advantage of minimal trauma , and is better to treat patella extraversion .


Noninvasive blood pressure ( NIBP ) monitoring methods are widely used in critically ill patients despite poor evidence of their accuracy .


The erroneous interpretations of blood pressure ( BP ) may lead to clinical errors .


To test the accuracy and reliability of aneroid ( ABP ) and oscillometric ( OBP ) devices compared to the invasive BP ( IBP ) monitoring in an ICU population .


Fifty adult patients ( 200 comparisons ) were included in a randomized crossover trial .


BP was recorded simultaneously by IBP and either by ABP or by OBP , taking IBP as gold standard .


Compared with ABP , IBP systolic values were significantly higher ( mean difference standard deviation 9.74 13.8 ; P < 0.0001 ) .


Both diastolic ( -5.13 7.1 ; P < 0.0001 ) and mean ( -2.14 7.1 ; P = 0.0033 ) IBP were instead lower .


Compared with OBP , systolic ( 10.80 14.9 ; P < 0.0001 ) and mean ( 5.36 7.1 ; P < 0.0001 ) IBP were higher , while diastolic IBP ( -3.62 6.0 ; P < 0.0001 ) was lower .


Bland-Altman plots showed wide limits of agreement in both NIBP-IBP comparisons .


BP measurements with different devices produced significantly different results .


Since in critically ill patients the importance of BP readings is often crucial , noninvasive techniques can not be regarded as reliable alternatives to direct measurements .


Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications .


Reports of serious adverse events followed , leading to its abandonment .


This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy ( ETAC ) compared with open inferior capsular shift ( ICS ) and reviews the role of randomized trials in adopting new technology .


Patients ( > 14years ) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled .


Patients with bone lesions or labral , biceps anchor , or full-thickness rotator cuff tears were excluded intraoperatively .


Outcomes included Western Ontario Shoulder Instability Index , function and recurrent instability at 2 years postoperatively , and surgical times .


Fifty-four subjects ( mean age , 23years ; 37 women ) were randomized to ETAC ( n = 28 ) or open ICS ( n = 26 ) .


The groups were comparable at baseline , except for external rotation at the side .


At 2 years postoperatively , there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index ( P = .71 ) , American Shoulder and Elbow Surgeons score ( P = .43 ) , Constant score ( P = .43 ) , and active range of motion .


Recurrent instability was not statistically different ( ETAC ,2 ; open ,4 ; P = .41 ) .


ETAC ( 23minutes ) was significantly shorter than open ICS ( 59minutes ) ( P < .01 ) surgery .


Three subjects ( 1 ETAC , 2 open ) had stiff shoulders .


At 2 years postoperatively , quality of life and functional outcomes between groups were not clinically different .


ETAC had fewer complications and episodes of recurrence compared with open surgery .


This evidence reinforces the need to critically evaluate new technology before widespread clinical use .


We compared the safety and efficacy of bipolar transurethral resection and monopolar resection for bladder tumors .


A single center , parallel arm , randomized , controlled trial was performed from May 2011 to August 2012 .


All patients with suspected bladder tumors were eligible for study inclusion .


Those who refused consent and those undergoing routine restaging transurethral resection of bladder tumor were excluded from analysis .


The primary end point was the incidence of obturator jerk .


Secondary study outcomes included the decrease in hematocrit , rates of recoagulation and transfusion , bladder perforation , decrease in sodium , resection syndrome and resection time .


Pathological quality was assessed by comparing deep muscle and the degree of severe cautery artifact in the 2 arms .


A total of 257 transurethral resections were performed during the study period .


After exclusion 147 patients were randomized , including 75 in the monopolar arm and 72 in the bipolar arm .


There were 6 and 4 protocol violations in the monopolar and bipolar arms , respectively .


Intent to treat and per protocol analyses were performed .


The incidence of obturator jerk was greater in the bipolar arm ( 60 % vs 49.2 % , p = 0.27 ) .


There was no significant difference between secondary outcomes .


The only significant difference was a significantly lower incidence of severe cautery artifact in the bipolar arm ( 25 % vs 46.7 % , p = 0.0096 ) .


Bipolar transurethral resection of bladder tumor was not superior to monopolar resection with respect to obturator jerk , bladder perforation and hemostasis .


There was a significantly lower incidence of severe cautery artifact after bipolar resection .


Safety and tolerability of peginterferon-based hepatitis C virus ( HCV ) infection therapy remains suboptimal , even when direct-acting antiviral agents are added .


This study assessed the efficacy , safety and tolerability of mericitabine combined with ritonavir-boosted danoprevir ( danoprevir/r ) ribavirin for up to 24 weeks in treatment-nave HCV genotype ( G ) 1 infected patients .


Patients received twice daily mericitabine ( 1000 mg ) and danoprevir/r ( 100 mg/100 mg ) plus either ribavirin ( 1000/1200 mg/day ; Arm A ) or placebo ( Arm B ) for 12 or 24 weeks .


Patients with HCV RNA < 43 IU/ml between Weeks 2 and 8 and HCV RNA < 15 IU/ml at Week 10 were rerandomized ( 1:1 ) at Week 12 to discontinue/continue assigned regimens until Week 24 .


Because of unacceptable relapse rates in both 12-week arms and in ribavirin-free Arm B , treatment was extended to 24 weeks and patients in Arm B received peginterferon alfa-2a / ribavirin .


The primary outcome was sustained virological response 24 weeks after end of treatment ( SVR24 ) .


In Arm A , the SVR24 rate in patients receiving 24 weeks of therapy was 37.9 % ( 25/66 ) ; 63.6 % ( 14/22 ) in G1b and 25.0 % ( 11/44 ) in G1a patients .


Virologic breakthrough and relapse were associated with danoprevir-resistant virus in most cases .


The mericitabine-resistance mutation ( NS5BS282T ) was detected in two patients bearing dual resistant virus NS3 R155K/NS5B S282T and dual resistance mutation L159F/L320F in one patient .


Treatment was safe and well tolerated .


Mericitabine , danoprevir/r plus ribavirin for 24 weeks were safe and well tolerated .


However , SVR rates were poor , achieving rates of only 25.0 % in G1a and 63.6 % in G1b patients .


To evaluate and compare 6-month effects of 8weeks of an integrative treatment ( IT ) , therapeutic acupuncture ( TA ) , and conventional treatment ( CT ) in reducing symptoms of anxiety , depression and in improving health-related quality of life ( HRQL ) and sense of coherence ( SOC ) in psychologically distressed primary care patients .


Patients who had participated in an open , pragmatic randomized controlled trial were followed up six months after treatment .


The study sample consisted of 120 adults ( 40 per treatment arm ) aged 20 to 55years referred from four different primary health care centres in western Sweden for psychological distress .


Assessments were made at baseline after eight weeks and after 24weeks .


Anxiety and depression were evaluated with the Hospital Anxiety and Depression scale ( HADS ) , HRQL with the SF-36 Mental Component Summary scores ( MCS ) and SOC with the Sense of Coherence-13 questionnaire .


No baseline differences were found between groups on any outcome variable .


At 24weeks , IT and TA had significantly better values than CT on all variables .


All three groups showed significant improvements from baseline on all variables , except HAD depression in CT ; however , improvements were significantly greater in IT and TA than in CT. .


IT and TA did not differ on any outcome variable .


Effect sizes were large in IT and TA for all variables and small or moderate in CT. .


Improvements on all variables seen after 8-weeks of IT and TA remained stable at 24weeks and the CT group improved on HAD anxiety .


IT and TA seem to be more beneficial than CT in reducing anxiety , depression , and in improving quality of life and sense of coherence after 24weeks of follow up in patients with psychological distress .


More research is needed to confirm these results .


ISRCTN trial number NCT01631500 .


The objective of the study is to determine the efficacy of oral granisetron ( a long-acting 5-HT3 receptor antagonist ) in stopping vomiting subsequent to discharge from emergency department ( ED ) , in 6-month-old to 8-year-old patients with gastroenteritis-related vomiting and dehydration , who had failed an initial trial of oral rehydration ( ORT ) .


Eligible patients were offered ORT on a slowly advancing schedule .


Patients who tolerated the initial ORT were discharged home .


Patients who vomited were randomized to receive either 40 g/kg of granisetron or placebo , and ORT was resumed .


Patients who tolerated the postrandomization ORT were discharged home with another dose of the study drug .


Parents were contacted by telephone every 24 hours until complete resolution of symptoms .


The primary outcome was the proportion of patients with vomiting at 24 hours .


Of the 900 eligible patients , 537 ( 60 % ) tolerated the initial ORT and were discharged home .


Of the patients who vomited during the initial ORT , 165 were included in the final study sample ( placebo , n = 82 ; granisetron , n = 83 ) .


There was no statistically significant difference in the proportion of patients with vomiting at 24 hours ( granisetron , n = 38 ; placebo , n = 45 ; odds ratio , 0.64 ; 95 % confidence interval , 0.34-1 .19 ; P = .16 ) .


A similar trend in the proportion of patients with vomiting was noted for the entire follow-up period ( granisetron , n = 43 ; placebo , n = 47 ; odds ratio , 0.73 ; P = .33 ; 95 % confidence interval , 0.39-1 .36 ) .


Granisetron was not effective in controlling gastroenteritis-related vomiting subsequent to discharge from ED .


It did not change the expected course of the illness .


Although many Latinos in the United States smoke , they receive assistance to quit less often than non-Latinos .


To address this disparity , we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment , when men 's partners were pregnant .


We compared two interventions : ( i ) written materials plus nicotine replacement therapy ( NRT ) to ( ii ) materials , NRT , and couple-based counseling that addressed smoking cessation and couples communication .


We recruited 348 expectant fathers who smoked via their pregnant partners from county health departments .


Our primary outcome was 7-day point prevalence smoking abstinence and was collected from November 2010 through April 2013 and analyzed in February 2014 .


We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy ( 0.31 vs. 0.30 , materials only vs. counseling , respectively ) and 12 months after randomization ( postpartum : 0.39 vs. 0.38 ) .


We found high quit rates among nondaily smokers but no arm differences ( 0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum ) .


Among daily smokers , we found lower quit rates with no arm differences but effects favoring the intervention arm ( 0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum ) .


A less intensive intervention promoted cessation equal to more intensive counseling .


Postpartum might be a more powerful time to promote cessation among Latino men .


Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities .


With ageing , the ability to mobilize fat is reduced and this , coupled with gradual decrease in lean body mass ( LBM ) from lessened exercise , allows for an increased body fat percentage ( % BF ) .


Exercising is considered a key to maintaining an appropriate body mass ( BM ) , as it improves fat oxidation , while maintaining LBM .


Although the effects of endurance and/or resistance training on fat mass ( FM ) and LBM in the elderly have well been established , limited data are forthcoming regarding the effects of Pilates as a training modality on these variables in the elderly .


The present study was therefore conducted to determine the effects of a mat Pilates programme on body fat in elderly women .


Fifty sedentary , apparently healthy females aged 60 years and older were randomly assigned a control ( CG , n = 25 ) or an intervention ( IG , n = 25 ) group .


The IG took part in an eight-week progressive mat Pilates exercise programme , three times weekly while the CG were instructed to maintain their normal daily activities throughout the eight-week experimental period .


All subjects underwent pre - and post-test in which FM and LBM were assessed .


Eight weeks of mat Pilates demonstrated a significant ( p 0.05 ) decrease in % BF ( p = 0.016 ) and FM ( p = 0.038 ) , with a significant increase in LBM ( p = 0.006 ) , while not showing any significant changes ( p 0.05 ) in BM ( p = 0.979 ) and BMI ( p = 0.992 ) .


The CG , however , did not produce any significant ( p 0.05 ) changes in any of the tested anthropometric variables ( BM : p = 0.266 ; BMI : p = 0.123 ; % BF : p = 0.516 ; FM : p = 0.937 and LBM : p = 0.522 ) after completion of the eight-week Pilates programme .


An eight-week mat Pilates exercise programme may contradict or even reverse some of the most serious consequences of ageing associated with an increased fat mass and reduced lean body mass in elderly females .


From an orthopedic point of view , wearing conventional ready to wear shoes negatively affects the front transverse arch of the human foot by forcing it into an unnatural inverted position .


The aim of the present orthopedic application study was to conduct a standardized assessment of the biomechanical effect of a newly developed , longitudinally flexible and cross stable spring steel insole by means of pedobarographic measurements and by means of a supplementary questioning of the participants .


In order to do this a total of 33 healthy adult participants were recruited in summer 2013 .


The randomized , blinded and controlled main study compared the cross stable insole made from spring steel with a flat , ordinary control insole made from ethylene vinyl acetate by means of pedobarographic in-shoe measurements at the forefoot .


Additionally , the subjectively perceived effect of the steel insole with respect to comfort , restricted mobility and pain was assessed in a randomized , blinded and controlled ancillary study , using a cross-over design .


Both the plantar peak pressure and the plantar force-time integral were significantly higher with the spring steel insole , especially in the central forefoot .


In the subsequent test phase lasting several weeks during which the participants were asked to wear the spring steel insole , they rarely complained about problems and in particular did not report negative effects regarding comfort , restricted mobility and pain compared to the ordinary control insoles .


The present study was conducted according to high methodological standards and proved for the first time that the tested spring steel insoles have a positive effect on the human forefoot .


The cross stability increases the pressure in the median ball area , prevents the unnatural inverted position of the forefoot and thus creating an effect which is comparable to walking barefoot .


As the participants did not judge this orthopedic effect of the cross stability as being uncomfortable , such an insole could be used a millionfold as a primary prevention in conventional shoes .


The standard recommended dose ( 0.1 U/kg per hour ) of insulin in diabetic ketoacidosis ( DKA ) guidelines is not backed by strong clinical evidence .


Physiologic dose-effect studies have found that even lower doses could adequately normalize ketonemia and acidosis .


Lowering the insulin dose may be advantageous in the initial hours of therapy when a gradual decrease in glucose , electrolytes , and resultant osmolality is desired .


To compare the efficacy and safety of low-dose insulin against the standard dose in children with DKA .


This was a prospective , open-label randomized clinical trial conducted in the pediatric emergency department and intensive care unit of a tertiary care teaching hospital in northern India from November 1 , 2011 , through December 31 , 2012 .


A total of 50 consecutive children 12 years or younger with a diagnosis of DKA were randomized to low-dose ( n = 25 ) and standard-dose ( n = 25 ) groups .


Low-dose ( 0.05 U/kg per hour ) vs standard-dose ( 0.1 U/kg per hour ) insulin infusion .


The primary outcome was the rate of decrease in blood glucose until a level of 250 mg/dL or less is reached ( to convert to millimoles per liter , multiply by 0.0555 ) .


The secondary outcomes included time to resolution of acidosis , episodes of treatment failures , and incidences of hypokalemia and hypoglycemia .


The mean ( SD ) rate of blood glucose decrease until a level of 250 mg/dL or less is reached ( 45.1 [ 17.6 ] vs 52.2 [ 23.4 ] mg/dL/h ) and the mean ( SD ) time taken to achieve this target ( 6.0 [ 3.3 ] vs 6.2 [ 2.2 ] hours ) were similar in the low - and standard-dose groups , respectively .


Mean ( SD ) length of time to achieve resolution of acidosis ( low vs standard dose : 16.5 [ 7.2 ] vs 17.2 [ 7.7 ] hours ; P = .73 ) and rate of resolution of acidosis were also similar in the groups .


Hypokalemia was seen in 12 children ( 48 % ) receiving the standard dose vs 5 ( 20 % ) of those receiving the low dose ( P = .07 ) ; the tendency was more pronounced in malnourished children ( 7 [ 88 % ] vs 2 [ 28 % ] ) .


Five children ( 20 % ) and 1 child ( 4 % ) receiving standard - and low-dose infusion ( P = .17 ) , respectively , developed hypoglycemia .


Treatment failure was rare and comparable .


One child in the standard-dose group developed cerebral edema , and no deaths occurred during the study period .


Low dose is noninferior to standard dose with respect to rate of blood glucose decrease and resolution of acidosis .


We advocate a superiority trial with a larger sample size before 0.05 U/kg per hour replaces 0.1 U/kg per hour in the practice recommendations .


ctri.nic.in Identifier : CTRI/2012/04 / 002548 .


Mosquito coils are the most commonly used household insecticidal product in the world with sales exceeding 50 billion coils , used by two billion people worldwide annually .


Despite strong evidence that coils prevent mosquito bites a systematic review concluded that there is no evidence that burning mosquito coils prevents malaria acquisition .


Therefore , the current trial was designed to measure and compare prevention of malaria infection by mosquito coils or long-lasting insecticidal net ( LLIN ) or a combination of the two in Yunnan , China in the Greater Mekong sub-region .


A four-arm single blind household-randomized design was chosen as coils emanate insecticide throughout the household .


Households enrolled at baseline were randomly allocated by the lottery method to one of the four intervention arms : ( i ) nothing , ( ii ) 0.03 % transfluthrin coils alone , ( iii ) deltamethrin long-lasting insecticide treated nets , ( LLINs ) alone or ( iv ) a combination of transfluthrin coils and deltamethrin LLINs .


All household members were recruited to the study , with only those households excluded with pregnant or breastfeeding mothers , members with chest complaints or allergies or members that regularly slept away from home .


The main outcome of interest was Plasmodium falciparum malaria prevalence detected by rapid diagnostic tests ( RDTs ) during six repeated monthly cross-sectional surveys .


The secondary outcome of interest was the effect on Plasmodium vivax prevalence detected in the same way .


A total of 2,052 households were recruited into the study , comprising 7,341 individuals The odds ratios of testing positive by RDT with P. falciparum or P. vivax were > 75 % lower for all intervention arms compared with the control arm .


Coils alone provided 77 % protection ( 95 % CI : 50 % -89 % ) , LLINs provided 91 % protection ( 95 % CI : 72 % -97 % ) and the combination of coils and LLINs provided 94 % protection ( 95 % CI : 77 % -99 % ) against P. falciparum compared with the control arm .


There was no statistically significant difference between the protective efficacies of the different interventions .


This is the first robust clinical evaluation of transfluthrin mosquito coils as a means to reduce malaria and the high degree of infection prevented would indicate they represent a potentially highly effective tool , which could be integrated into larger vector control programmes .


ClinicalTrials.gov Identifier : NCT00442442 , March 2007 .


Postoperative gastrointestinal dysfunction ( PGD ) is one of the most common complications following major surgeries under general anesthesia ( GA ) .


Despite ongoing research and new drug treatments , abdominal distension within 24 h postoperatively occurs in 8 % -28 % of all surgeries .


We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan ( PC6 ) , Zusanli ( ST36 ) and Shangjuxu ( ST37 ) bilaterally twice a day compared with sham-acupuncture treatment and standard treatment .


This is a single-center , prospective practical randomized controlled trial .


All groups will be given standard treatments .


Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University , China , and divided into three groups .


The experimental group will receive routine treatments and acupuncture at PC6 , ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively .


The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6 , ST36 and ST37 , which are 1 cun away from the real acupoints .


The routine-treatment group will not receive electroacupuncture .


The outcomes include the incidence of abdominal distention , abdominal circumference , the degree of abdominal distension , the first time of flatus and defecation , and hospitalization duration .


The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. .


This study may also provide a standardized acupuncture treatment for reduction of PGD .


Factors influencing prostate-specific antigen ( PSA ) changes in men undergoing testosterone ( T ) therapy have not been well studied .


The aim of this study was to assess the influence of selected variables on PSA changes in hypogonadal men administered with 1.62 % testosterone gel ( T-gel ) for 6 months .


A double-blind , placebo-controlled study of 274 ( 234 T-gel , 40 placebo ) hypogonadal men > 18 years of age , with baseline T concentrations < 300ng/dL , PSA2 .5 ng/mL , and negative digital rectal examination .


Subjects received once-daily T-gel for T therapy .


Changes in mean serum PSA , percentage of free PSA ( % fPSA ) , and T from baseline to 6 months ( 182 days ) .


Mean age was 53.5 years and baseline mean values were total T 247ng/dL , PSA 0.9 ng/mL , and % fPSA 24.6 % .


Among men treated with T-gel , T increased to 499ng/dL and PSA increased by 0.1 ng/mL ( P = 0.0012 ) .


PSA increased 0.3 ng/mL in 26.3 % , < 0.3 ng/mL in 73.7 % , including a decline from baseline in 33.0 % .


In the placebo group , T increased 29ng/dL to 274ng/dL , and PSA decreased 0.1 ng/mL , compared with baseline .


A greater increase in PSA was noted in men 60 years old than in men < 60 years old ( 0.4 vs. 0.05 ng/mL , respectively ; P = 0.0006 ) .


Mean PSA did not change in men with baseline serum T > 250ng/dL , whereas it increased by 0.2 ng/mL in men with T250ng/dL ( P = 0.0031 ) .


PSA increased 0.3 ng/mL in men with baseline % fPSA < 20 % and 0.1 ng/mL in men with % fPSA20 % .


Overall , T-gel treatment was associated with a minor increase in PSA , of questionable clinical significance .


Factors predicting greater PSA increases included age 60 years , baseline T250ng/dL , and % fPSA < 20 % .


Men with T > 250ng/dL and age < 60 years demonstrated minimal or no PSA change .


The objective of the current study was to compare surgeon-rated visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine .


Eighty-three patients were randomized to receive irrigation fluid with ( 44 patients ) or without ( 39 patients ) epinephrine during their arthroscopic shoulder procedures .


After each procedure , the blinded senior author ( G.F.C. ) evaluated visualization based on a visual analog scale ( VAS ) , and all clinically important procedure variables were recorded .


Eighty-three arthroscopic shoulder procedures were included in the study .


Fifty-four of these procedures were arthroscopic rotator cuff repairs , allowing a subset analysis of this specific procedure .


There was a significant difference , with improved visualization in the epinephrine group versus the group without epinephrine when comparing all procedures ( P < .0001 ) and when comparing only rotator cuff repairs ( P < .0001 ) .


However , there was no statistical difference in other clinically important variables , including operative time and amount of irrigation fluid used .


The addition of epinephrine to irrigation fluid significantly improves surgeon-rated visualization in shoulder arthroscopy .


Without an observed significant difference in operative time or volume of irrigation fluid used , the clinical significance of this improved visualization is unclear , and the use of irrigation fluid without epinephrine remains a viable option in the hands of an experienced surgeon .


Level I , high-quality randomized controlled trial with statistically significant difference .


After percutaneous coronary intervention ( PCI ) for non-ST-segment elevation myocardial infarction ( NSTEMI ) , treatment with a P2Y12 antagonist with aspirin is recommended for 1 year .


The oral P2Y12 antagonists ticagrelor and prasugrel have higher recommendations than clopidogrel , but it is unknown if administration before the start of PCI is beneficial .


In the randomized , double-blind ACCOAST ( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction ) trial , 4,033 patients were diagnosed with NSTEMI and 68.7 % underwent PCI ; 1,394 received pre-treatment with prasugrel ( 30-mg loading dose ) , and 1,376 received placebo .


At the time of PCI , patients who received pre-treatment with prasugrel received an additional 30-mg dose of prasugrel , and those who received placebo received a 60-mg loading dose of prasugrel .


Primary efficacy was a composite of cardiovascular death , myocardial infarction , stroke , urgent revascularization , or glycoprotein IIb/IIIa bailout through 7 days from randomization .


Investigators captured the presence of thrombus on initial angiography and during PCI .


The incidence of the primary endpoint through 7 days from randomization in the pre-treatment group versus the no pre-treatment group was 13.1 % versus 13.1 % ( p = 0.93 ) .


Pre-treatment with prasugrel was not associated with decreases in any ischemic event , including total mortality .


Patients with thrombus on angiography had a 3-fold higher incidence of the primary endpoint than patients without thrombus .


There was no impact of pre-treatment with prasugrel on the presence of thrombus before PCI or on occurrence of stent thrombosis after PCI .


There was a 3-fold increase in all non-coronary artery bypass graft Thrombolysis In Myocardial Infarction ( TIMI ) major bleeding and a 6-fold increase in non-coronary artery bypass graft life-threatening bleeding with pre-treatment with prasugrel ; the same trends persisted in patients who had radial or femoral access even with use of a closure device .


These findings support deferring treatment with prasugrel until a decision is made about revascularization in patients with NSTEMI undergoing angiography within 48 h of admission .


( A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction [ ACCOAST ] ; NCT01015287 ) .


High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex ( rTMS-DLPFC ) is an effective treatment for depression .


Preliminary studies indicated beneficial effects of rTMS-DLPFC on pain relief in patients treated for depression , and in patients with chronic migraine .


In this randomized , double-blind , parallel-group , single-center , proof-of-principle clinical trial , we tested the hypothesis that 23 sessions of active rTMS-DLPFC delivered over eight weeks would be feasible , safe and superior to sham rTMS to decrease the number of headache days in 18 patients with chronic migraine without severe depression .


Per-protocol analysis was performed .


rTMS-DLPFC applied over eight weeks was feasible and safe in patients with chronic migraine .


Contrary to our primary hypothesis , the number of headache days decreased significantly more in the sham group than in the group treated with active rTMS-DLPFC at eight weeks .


Average decrease in headache days was > 50 % in the sham group , indicating a powerful placebo response .


Pain intensity improved in both groups to a similar extent .


Positive results of M1 stimulation in other studies , and the absence of significant benefits of active high-frequency rTMS of the DLPFC in the present study , point to M1 as a more promising target than the DLPFC , for larger trials of noninvasive brain stimulation in patients with chronic migraine .


Colorectal cancer ( CRC ) is the second most prevalent type of cancer in Europe .


A single flexible sigmoidoscopy ( FS ) screening at around the age of 60 years prevents about one-third of CRC cases .


However , FS screens only the distal colon , and thus mortality from proximal CRC is unaffected .


Computed tomography colonography ( CTC ) is a highly accurate examination that allows assessment of the entire colon .


However , the benefit of CTC testing as a CRC screening test is uncertain .


We designed a randomized trial to compare participation rate , detection rates , and costs between CTC ( with computer-aided detection ) and FS as primary tests for population-based screening .


An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years , living in the Piedmont region and the Verona district of Italy .


Individuals with a history of CRC , adenomas , inflammatory bowel disease , or recent colonoscopy , or with two first-degree relatives with CRC will be excluded from the study by their general practitioners .


Individuals responding positively to the invitation letter will be then randomized to the intervention group ( CTC ) or control group ( FS ) , and scheduled for the screening procedure .


The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests .


Secondary outcomes are cost-effectiveness analysis , referral rates for colonoscopy induced by CTC versus FS , and the expected and perceived burden of the procedures .


To compare participation rates for CTC versus FS , 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS .


In the CTC arm , non-responders will be offered fecal occult blood test ( FOBT ) as alternative screening test , while in the FS arm , non-responders will receive an invitation letter to undergo screening with either FOBT or CTC .


Data on reasons for participation and non-participation will also be collected .


This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS .


The trial will also evaluate the role of computer-aided detection in a screening setting .


ClinicalTrials.gov Identifier : NCT01739608 .


Awake regional anesthesia ( RA ) is a viable alternative to general anesthesia ( GA ) for infants undergoing lower abdominal surgery .


Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes .


The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants .


The aim of the study is to describe success and failure rates of RA and report factors associated with failure .


This was a nested cohort study within a prospective , randomized , controlled , observer-blind , equivalence trial .


Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA ( spinal , caudal epidural , or combined spinal caudal anesthetic ) or GA with sevoflurane .


The data of 339 infants , where spinal or combined spinal caudal anesthetic was attempted , were analyzed .


Possible predictors of failure were assessed including patient factors , technique , experience of site and anesthetist , and type of local anesthetic .


RA was sufficient for the completion of surgery in 83.2 % of patients .


Spinal anesthesia was successful in 86.9 % of cases and combined spinal caudal anesthetic in 76.1 % .


Thirty-four patients required conversion to GA , and an additional 23 patients ( 6.8 % ) required brief sedation .


Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure ( odds ratio = 2.46 ) .


The failure rate of spinal anesthesia was low .


Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone .


To compare a multicomponent motivational interviewing ( MI ) / self-management ( SM ) intervention with a multicomponent education intervention to improve skin-protective behaviors and prevent skin worsening in veterans with spinal cord injury ( SCI ) hospitalized for severe pressure ulcers ( PrUs ) .


Single-blinded , prospective , randomized controlled trial .


Six Veterans Affairs SCI centers .


Veterans admitted for a severe ( stage III/IV ) PrU were followed up to 6 months postdischarge .


Telephone-based individual MI counseling plus SM skills group ( SM+MI ; n = 71 ) versus an active control group of telephone-based individual educational counseling plus group education ( n = 72 ) .


Self-reported skin-protective behaviors , objective skin worsening .


Intention-to-treat analyses found nonsignificant increases in skin behaviors in the SM+MI versus education control intervention arms at 3 and 6 months .


The difference in behaviors used between SM+MI and education control intervention participants was 4.6 % ( 95 % confidence interval [ CI ] , -11.3 to 2.7 ) ( 0-3mo ) and 3.0 % ( 95 % CI , -8.7 to 3.9 ) ( 0-6mo ) .


High rates of skin worsening were observed ( n = 74 , 51.7 % ) , usually within 3 months postdischarge and most frequently within the month postdischarge .


Skin worsening , skin-related visits , and readmissions did not differ by study arm .


Study limitations are presented .


For persons with chronic SCI and severe PrUs , complicated by multiple comorbidities , a primary focus on improving patient behavior is likely insufficient to address the complex problem of PrUs in SCI .


More health care systems-level changes such as collaborative care may be needed to reduce PrU recurrence , especially in this era in which many people are discharged from the hospital unhealed or with little sitting tolerance .


Orteronel is an investigational , partially selective inhibitor of CYP 17,20-lyase in the androgen signalling pathway , a validated therapeutic target for metastatic castration-resistant prostate cancer .


We assessed orteronel in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .


In this phase 3 , double-blind , placebo-controlled trial , we recruited patients with progressive metastatic castration-resistant prostate cancer and no previous chemotherapy from 324 study centres ( ie , hospitals or large urologic or group outpatient offices ) in 43 countries .


Eligible patients were randomly assigned in a 1:1 ratio to receive either 400 mg orteronel plus 5 mg prednisone twice daily or placebo plus 5 mg prednisone twice daily .


Randomisation was done centrally with an interactive voice response system and patients were stratified by region ( Europe , North America , and not Europe or North America ) and the presence or absence of radiographic disease progression at baseline .


The two primary endpoints were radiographic progression-free survival and overall survival , determined in the intention-to-treat population .


This trial is registered with ClinicalTrials.gov , number NCT01193244 .


From Oct 31 , 2010 , to June 29 , 2012 , 2353 patients were assessed for eligibility .


Of those , 1560 were randomly assigned to receive either orteronel plus prednisone ( n = 781 ) or placebo plus prednisone ( n = 779 ) .


The clinical cutoff date for the final analysis was Jan 15 , 2014 ( with 611 deaths ) .


Median follow-up for radiographic progression-free survival was 84 months ( IQR 37-166 ) .


Median radiographic progression-free survival was 138 months ( 95 % CI 131-149 ) with orteronel plus prednisone and 87 months ( 83-109 ) with placebo plus prednisone ( hazard ratio [ HR ] 071 , 95 % CI 063-080 ; p < 00001 ) .


After a median follow-up of 207 months ( IQR 142-254 ) , median overall survival was 314 months ( 95 % CI 286-not estimable ) with orteronel plus prednisone and 295 months ( 270-not estimable ) with placebo plus prednisone ( HR 092 , 95 % CI 079-108 ; p = 031 ) .


The most common grade 3 or worse adverse events were increased lipase ( 137 [ 17 % ] of 784 patients in the orteronel plus prednisone group vs 14 [ 2 % ] of 770 patients in the placebo plus prednisone group ) , increased amylase ( 77 [ 10 % ] vs nine [ 1 % ] ) , fatigue ( 50 [ 6 % ] vs 14 [ 2 % ] ) , and pulmonary embolism ( 40 [ 5 % ] vs 27 [ 4 % ] ) .


Serious adverse events were reported in 358 [ 46 % ] patients receiving orteronel plus prednisone and in 292 [ 38 % ] patients receiving placebo plus prednisone .


In chemotherapy-naive patients with metastatic castration-resistant prostate cancer , radiographic progression-free survival was prolonged with orteronel plus prednisone versus placebo plus prednisone .


However , no improvement was noted in the other primary endpoint , overall survival .


Orteronel plus prednisone was associated with increased toxic effects compared with placebo plus prednisone .


On the basis of these and other data , orteronel is not undergoing further development in metastatic castration-resistant prostate cancer .


Millennium Pharmaceuticals , Inc , a wholly owned subsidiary of Takeda Pharmaceutical Company Limited .


Vortioxetine is a recently approved multimodal antidepressant with anxiolytic properties in preclinical studies .


This double-blind , placebo-controlled study assessed the efficacy and tolerability of vortioxetine in subjects with a primary diagnosis of generalized anxiety disorder .


Subjects ( n = 457 ) were randomized 1:1:1 to treatment with placebo or vortioxetine 2.5 or 10mg once daily .