Secondary end points were the 6-minute walk distance , progression-free survival , dyspnea , and death from any cause or from idiopathic pulmonary fibrosis .


In the pirfenidone group , as compared with the placebo group , there was a relative reduction of 47.9 % in the proportion of patients who had an absolute decline of 10 percentage points or more in the percentage of the predicted FVC or who died ; there was also a relative increase of 132.5 % in the proportion of patients with no decline in FVC ( P < 0.001 ) .


Pirfenidone reduced the decline in the 6-minute walk distance ( P = 0.04 ) and improved progression-free survival ( P < 0.001 ) .


There was no significant between-group difference in dyspnea scores ( P = 0.16 ) or in rates of death from any cause ( P = 0.10 ) or from idiopathic pulmonary fibrosis ( P = 0.23 ) .


However , in a prespecified pooled analysis incorporating results from two previous phase 3 trials , the between-group difference favoring pirfenidone was significant for death from any cause ( P = 0.01 ) and from idiopathic pulmonary fibrosis ( P = 0.006 ) .


Gastrointestinal and skin-related adverse events were more common in the pirfenidone group than in the placebo group but rarely led to treatment discontinuation .


Pirfenidone , as compared with placebo , reduced disease progression , as reflected by lung function , exercise tolerance , and progression-free survival , in patients with idiopathic pulmonary fibrosis .


Treatment was associated with an acceptable side-effect profile and fewer deaths .


( Funded by InterMune ; ASCEND ClinicalTrials.gov number , NCT01366209 . )


This study examined the effects of preoperative incentive spirometry ( IS ) education ( POISE ) on postoperative outcomes for knee and hip total joint replacement patients .


In this prospective study , 140 patients were randomized to Group 1 ( POISE intervention = 50 completing ) or Group 2 ( no intervention = 56 completing ) ( 34 dropped ) .


The Group 1 intervention consisted of formal instruction preoperatively for IS home use , postoperative use , and IS volumes documentation .


Group 2 patients received no intervention .


Patients recorded postoperative IS volumes , which were used to determine return to baseline volume .


One hundred six patients completed the study .


Most were Caucasian females averaging 64 years .


Although IS return to baseline volume time was not significantly different between groups , POISE patients had fewer postoperative complications , hospital days , and charges .


POISE patients ranked the intervention as helpful .


Although IS volumes were not significantly different between groups , POISE patients had better outcomes and ranked the intervention as helpful .


Acute pancreatitis is a severe condition that requires early identification of patients at risk of developing potentially lethal complications .


Current clinical scoring systems and biochemical parameters are insufficient .


In this study , we aimed to assess whether early plasma Angiopoietin-2 ( Ang-2 ) is associated with adverse outcomes in patients with predicted severe acute pancreatitis ( SAP ) .


This analysis is a substudy of the PROPATRIA trial ( probiotics vs placebo in patients with predicted SAP ) .


The Ang-2 levels were measured prospectively in plasma in the first 5 days after admission in 115 patients .


Early Ang-2 levels were higher in patients who developed SAP : 6.4 vs 3.1 g/L ( p < 0.001 ) and also were higher in patients who developed multiorgan failure in the first week ( p = 0.001 ) and after the first week ( p = 0.049 ) .


Furthermore , high Ang-2 levels were associated with infectious complications in the first week ( p < 0.001 ) and after the first week ( p < 0.001 ) .


Finally , plasma Ang-2 was significantly higher in patients who died ( p < 0.001 ) and in patients who developed bowel ischemia ( p < 0.001 ) .


As a predictor of adverse outcomes , plasma Ang-2 was superior to a number of current scores , such as the APACHE II score , the Imrie score , C-reactive protein , lipopolysaccharide binding protein , and procalcitonin .


In the setting of this randomized controlled trial , early plasma Ang-2 was found to be an accurate predictor of SAP , multiorgan failure , and infectious complications .


As a biomarker , it did outperform all of the investigated conventional predictors that are currently used in clinical practice .


To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis ( pcJIA ) .


This three-part , randomised , placebo-controlled , double-blind withdrawal study ( NCT00988221 ) included patients who had active pcJIA for 6months and inadequate responses to methotrexate .


During part 1 , patients received open-label tocilizumab every 4weeks ( 8 or 10mg/kg for body weight ( BW ) < 30kg ; 8mg/kg for BW 30kg ) .


At week 16 , patients with JIA-American College of Rheumatology ( ACR ) 30 improvement entered the 24-week , double-blind part 2 after randomisation 1:1 to placebo or tocilizumab ( stratified by methotrexate and steroid background therapy ) for evaluation of the primary end point : JIA flare , compared with week 16 .


Patients flaring or completing part 2 received open-label tocilizumab .


In part 1 , 188 patients received tocilizumab ( < 30kg : 10mg/kg ( n = 35 ) or 8mg/kg ( n = 34 ) ; 30kg : n = 119 ) .


In part 2 , 163 patients received tocilizumab ( n = 82 ) or placebo ( n = 81 ) .


JIA flare occurred in 48.1 % of patients on placebo versus 25.6 % continuing tocilizumab ( difference in means adjusted for stratification : -0.21 ; 95 % CI -0.35 to -0.08 ; p = 0.0024 ) .


At the end of part 2 , 64.6 % and 45.1 % of patients receiving tocilizumab had JIA-ACR70 and JIA-ACR90 responses , respectively .


Rates/100 patient-years ( PY ) of adverse events ( AEs ) and serious AEs ( SAEs ) were 480 and 12.5 , respectively ; infections were the most common SAE ( 4.9 / 100 PY ) .


Tocilizumab treatment results in significant improvement , maintained over time , of pcJIA signs and symptoms and has a safety profile consistent with that for adults with rheumatoid arthritis .


NCT00988221 .


Postprandial triglyceride ( TG ) concentration is independently associated with cardiovascular disease risk .


Exercise reduces postprandial TG concentrations , but the mechanisms responsible are unclear .


The objective was to determine the effects of exercise on affinity of chylomicrons , large very low-density lipoproteins ( VLDL1 ) , and smaller VLDL ( VLDL2 ) for lipoprotein lipase ( LPL ) - mediated TG hydrolysis .


This was designed as a within-participant crossover study .


The setting was a university metabolic investigation unit .


Participants were 10 overweight/obese men .


Participants undertook two oral fat tolerance tests , separated by 7-14 days , in which they had blood taken while fasting and for 4 hours after a high-fat mixed meal .


On the afternoon before one test , they performed a 90-minute treadmill walk at 50 % maximal oxygen uptake ( exercise trial [ EX ] ) ; no exercise was performed before the control trial ( CON ) .


We measured circulating TG-rich lipoprotein concentrations and affinity of chylomicrons , VLDL1 , and VLDL2 for LPL-mediated TG hydrolysis .


Exercise significantly reduced fasting VLDL1-TG concentration ( CON , 0.49 [ 0.33-0 .72 ] mmol.L ( -1 ) ; EX , 0.36 [ 0.22-0 .59 ] mmol.L ( -1 ) ; geometric means [ 95 % confidence interval ] ; P = .04 ) .


Time-averaged postprandial chylomicron-TG ( CON , 0.55 0.10 mmol.L ( -1 ) ; EX , 0.39 0.08 mmol.L ( -1 ) ; mean SEM ; P = .03 ) and VLDL1-TG ( CON , 0.85 0.13 mmol.L ( -1 ) ; EX , 0.66 0.10 mmol.L ( -1 ) ; P = .01 ) concentrations were both lower in EX than CON .


Affinity of VLDL1 for LPL-mediated TG hydrolysis increased by 2.2 ( 1.3-3 .7 ) - fold [ geometric mean ( 95 % confidence interval ) ] ( P = .02 ) in the fasted state and 2.6 ( 1.8-2 .6 ) - fold ( P = .001 ) postprandially .


Affinity of chylomicrons and VLDL2 was not significantly different between trials .


Exercise increases affinity of VLDL1 for LPL-mediated TG hydrolysis both fasting and postprandially .


This mechanism is likely to contribute to the TG-lowering effect of exercise .


Moxibustion is one of the most commonly used therapies in acupuncture practice , and is demonstrated to be beneficial for patients with diarrhea from irritable bowel syndrome ( D-IBS ) .


But its mechanism remains unclear .


Because visceral hypersensitivity in IBS patients has been documented by evaluation of perceived stimulations through functional magnetic resonance imaging ( fMRI ) studies , we focused on observing brain imaging changes in D-IBS patients during rectal balloon distention before and after moxibustion in order to reveal its possible central mechanism and further evaluate its effect .


This clinical trial is registered under the number : ChiCTR-TRC-10000887 .


Eighty D-IBS patients were randomly divided into a moxibustion and sham moxibustion group ( control group ) for a 4-week treatment .


Fifteen patients in moxibustion group and thirteen patients in control group completed two fMRI scans during a 50 and 100ml rectal balloon distention before and after treatment .


Rectal pain were obtained with a scan test .


Birmingham IBS Symptom Scale and IBS Quality of Life ( QOL ) Scale were used to evaluate therapeutic effect .


After treatment , the decrease in Birmingham IBS Symptom Scale and IBS QOL Scale scores in moxibustion group was significantly greater than that of control group ( P < 0.01 ) .


The defecation urge threshold and the pain perception threshold of moxibustion group was also significantly higher after treatment than that of control group ( P < 0.01 ) .


The decrease in pain score during the 100ml rectal balloon distention in moxibustion group was significantly greater than that of control group ( P < 0.05 ) .


There was no definite activated center during the 50ml rectal distention in either group before treatment .


After treatment , the prefrontal cortex ( PFC ) was affected in moxibustion group , while the PFC and the anterior cingulated cortex ( ACC ) were affected in control group .


During the 100ml distention before treatment in both groups , the PFC and ACC were activated .


After treatment , they disappeared in moxibustion group but remained in control group .


Moxibustion can improve symptoms and quality of life in D-IBS patients .


It can also decrease rectal sensitivity .


The activation of PFC and ACC during a 100ml rectal distention disappeared after moxibustion treatment .


Most dental procedures require a dry working environment .


Although many evaporative drying methods are available , an additional reduction of salivary flow would often be helpful .


This prospective randomized cross-over study compares salivary production in 31 volunteers during direct , indirect , and non-suggestive ( control group ) intervention .


Overall , each volunteer underwent four salivation measurements , i.e. two measurements during two different types of hypnotic suggestion ( indirect and direct ) arranged in random order and two control sections .


All four measurements were conducted successively .


Both suggestive methods significantly reduced salivary production in comparison to the two control sections ( direct suggestion = 1.46 grams per 5 min , p < 0.001 , indirect suggestion = 0.94 grams per 5 min , p = 0.039 ) .


Direct suggestion showed a significantly higher reduction of salivary production than indirect suggestion ( = -0.53 grams per 5 min , p = 0.001 ) .


Hypnotic suggestion represents a simple and inexpensive method to reduce salivation and could thus create a better working environment for more comfortable dental treatments for both patients and dentists .


Artemisinin combination therapies ( ACTs ) with broad efficacy are needed where multiple Plasmodium species are transmitted , especially in children , who bear the brunt of infection in endemic areas .


In Papua New Guinea ( PNG ) , artemether-lumefantrine is the first-line treatment for uncomplicated malaria , but it has limited efficacy against P. vivax .


Artemisinin-naphthoquine should have greater activity in vivax malaria because the elimination of naphthoquine is slower than that of lumefantrine .


In this study , the efficacy , tolerability , and safety of these ACTs were assessed in PNG children aged 0.5-5 y.


An open-label , randomized , parallel-group trial of artemether-lumefantrine ( six doses over 3 d ) and artemisinin-naphthoquine ( three daily doses ) was conducted between 28 March 2011 and 22 April 2013 .


Parasitologic outcomes were assessed without knowledge of treatment allocation .


Primary endpoints were the 42-d P. falciparum PCR-corrected adequate clinical and parasitologic response ( ACPR ) and the P. vivax PCR-uncorrected 42-d ACPR .


Non-inferiority and superiority designs were used for falciparum and vivax malaria , respectively .


Because the artemisinin-naphthoquine regimen involved three doses rather than the manufacturer-specified single dose , the first 188 children underwent detailed safety monitoring .


Of 2,542 febrile children screened , 267 were randomized , and 186 with falciparum and 47 with vivax malaria completed the 42-d follow-up .


Both ACTs were safe and well tolerated .


P. falciparum ACPRs were 97.8 % and 100.0 % in artemether-lumefantrine and artemisinin-naphthoquine-treated patients , respectively ( difference 2.2 % [ 95 % CI -3.0 % to 8.4 % ] versus -5.0 % non-inferiority margin , p = 0.24 ) , and P. vivax ACPRs were 30.0 % and 100.0 % , respectively ( difference 70.0 % [ 95 % CI 40.9 % -87.2 % ] , p < 0.001 ) .


Limitations included the exclusion of 11 % of randomized patients with sub-threshold parasitemias on confirmatory microscopy and direct observation of only morning artemether-lumefantrine dosing .


Artemisinin-naphthoquine is non-inferior to artemether-lumefantrine in PNG children with falciparum malaria but has greater efficacy against vivax malaria , findings with implications in similar geo-epidemiologic settings within and beyond Oceania .


Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .


Please see later in the article for the Editors ' Summary .


To investigate the safety and maximum tolerable dosage of injectable cefetamet sodium Sixty healthy volunteers were enrolled in this study .


with a single infusion in Chinese healthy volunteers .


A double-blinded , randomized , placebo-controlled design was adopted .


Eight dosages ranging from 100 mg to 5 000 mg were tested .


The pharmacokinetics of the drug was analyzed using a Latin square three-cross self-controlled design , with 12 healthy volunteers receiving 500 mg , 1 000 mg and 2 000 mg of injectable cefetamet sodium in a randomized sequence .


Blood and urine samples were collected and analyzed using high performance liquid chromatography with UV detection .


The main pharmacokinetics parameters were calculated with DAS2 .0 software .


59 healthy volunteers completed the tolerance tests .


Clinical adverse reactions occurred in 22.73 % of participants in the test group and 6.67 % of participants in the placebo group ; but the difference was not statistically significant .


Common adverse events included infusion pain and dizziness .


Rare adverse events such as palpitations , diarrhea and rash occurred in participants in the test group .


All of the adverse reactions were mild .


Abnormal laboratory test results occurred in 43.18 % participants in the test group and 53.33 % participants in the placebo group ; again the difference was not statistically significant .


Common abnormal laboratory test results included abnormal bowel flora , stool abnormalities , abnormal urine and elevated serum potassium .


After a single infusion of 500 mg , 1 000 mg and 2 000 mg of injectable cefetamet sodium , peak concentration of the drug at 0.5 h reached ( 37.92 + / - 7.43 ) , ( 74.90 + / - 10.67 ) and ( 148.54 + / - 31.63 ) mg/L , with areas under concentration-time curve of ( 72.08 + / - 14.98 ) , ( 144.28 + / - 24.57 ) and ( 286.66 + / - 54.25 ) ( mg x h ) / L , respectively .


Their elimination half-life was ( 2.03 + / - 0.38 ) , ( 2.04 + / - 0.26 ) , and ( 2.12 + / - 0.26 ) h , respectively .


The disposition of cefetamet was presented as a two-compartment model with linear kinetics .


The 24-hour urinary accumulation excretion was 76.6 % -67.5 % .


The maximum single tolerated dose of injectable cefetamet sodium is 5 000 mg .


The pharmacokinetics is a two-compartment model with linear kinetics within a dose range 500-2 000 mg .


Whether the combination of a once-daily inhaled corticosteroid with a once-daily longacting ( 2 ) agonist is more protective than a once-daily longacting ( 2 ) agonist alone against exacerbations of chronic obstructive pulmonary disease ( COPD ) is unknown .


We hypothesised that fluticasone furoate and vilanterol would prevent more exacerbations than would vilanterol alone .


We did two replicate double-blind parallel-group 1 year trials .


Both studies began on Sept 25 , 2009 .


Study 1 ended on Oct 31 , 2011 , and study 2 on Oct 17 , 2011 .


Eligible patients were aged 40 years or older , had a history of COPD , a smoking history of 10 or more pack-years , a ratio of forced expiratory volume in 1 s ( FEV ( 1 ) ) to forced vital capacity of 070 or less after bronchodilators ( and an FEV ( 1 ) of 70 % or less of predicted ) , and a documented history of one or more moderate or severe disease exacerbations in the year before screening .


Patients were randomly assigned ( 1:1:1:1 ) on the basis of the Registration and Medication Ordering System to 25 g vilanterol alone or 25 g vilanterol combined with either 50 g , 100 g , or 200 g fluticasone furoate once daily .


Our primary endpoint was the yearly rate of moderate and severe exacerbations .


The trials were analysed separately and a pooled analysis was also done .


These trials are registered with ClinicalTrials.gov ( NCT01009463 and NCT01017952 ) .


1622 patients in study 1 and 1633 patients in study 2 were randomly assigned .


In study 1 , no significant difference in exacerbation rate was noted between the 200/25 g fluticasone furoate/vilanterol group and the vilanterol only group ( mean 090 events vs 105 events per year ; ratio 09 [ 95 % CI 07-10 ] ) .


Because of the statistical hierarchy used , we could not infer significance for the 50 g and 100 g groups .


In study 2 , significantly fewer moderate and severe exacerbations were noted in all fluticasone furoate/vilanterol groups than in the vilanterol only group ( p = 00398 for the 50 g group , 00244 for the 100 g group , and 00004 for the 200 g group ) .


In the pooled analysis , significantly fewer moderate and severe exacerbations were noted in all fluticasone furoate/vilanterol groups than in the vilanterol only group ( 00141 for the 50 g group , < 00001 for the 100 g group , and 00003 for the 200 g group ) .


Nasopharyngitis was the most frequently reported adverse event in both studies .


Pneumonia and fractures were reported more frequently with fluticasone furoate and vilanterol than with vilanterol alone .


Eight deaths from pneumonia were noted in the fluticasone furoate/vilanterol groups compared with none in the vilanterol only group .


Addition of fluticasone furoate to vilanterol was associated with a decreased rate of moderate and severe exacerbations of COPD in patients with a history of exacerbation , but was also associated with an increased pneumonia risk .


GlaxoSmithKline .


Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction .


Many of the reported data are from low level-of-evidence studies , leaving many questions incompletely answered .


The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix .


A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix .


The impact of body mass index , smoking , diabetes , mastectomy type , radiation therapy , and chemotherapy on outcomes was analyzed .


Acellular dermal matrix biointegration was analyzed clinically and histologically .


Patient satisfaction was assessed by means of preoperative and postoperative surveys .


Logistic regression models were used to identify predictors of complications .


This article reports on the study design , surgical technique , patient characteristics , and preoperative survey results , with outcomes data in a separate report .


After 2.5 years , we successfully enrolled and randomized 128 patients ( 199 breasts ) .


The majority of patients were healthy nonsmokers , with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy .


Half of the mastectomies were prophylactic , with nipple-sparing mastectomy common in both cancer and prophylactic cases .


Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education .


Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction .


Therapeutic , II .


To investigate the effect of whey protein plus potassium bicarbonate supplement on disused skeletal muscle structure and proteolysis after bed rest ( BR ) .


Soleus ( SOL ) and vastus lateralis ( VL ) biopsies were sampled from ten ( n = 10 ) healthy male subjects ( aged 316 years ) who did BR once with and once without protein supplement as a dietary countermeasure ( cross-over study design ) .


The structural changes ( myofibre size and type distribution ) were analysed by histological sections , and muscle protein breakdown indirectly via the proteolysis markers , calpain 1 and 3 , calpastatin , MuRF1 and 2 , both in muscle homogenates and by immunohistochemistry .


BR caused size-changes in myofiber cross-sectional area ( FCSA , SOL , p = 0,004 ; VL , p = 0.03 ) , and myofiber slow-to-fast type transition with increased hybrids ( SOL , p = 0.043 ; VL , p = 0.037 ) however with campaign differences in SOL ( p < 0.033 ) .


No significant effect of BR and supplement was found by any of the key proteolysis markers .


Campaign differences in structural muscle adaptation may be an issue in cross-over design BR studies .


The whey protein plus potassium bicarbonate supplement did not attenuate atrophy and fibre type transition during medium term bed rest .


Alkaline whey protein supplements may however be beneficial as adjuncts to exercise countermeasures in disuse .


Visceral and shoulder tip pain following laparoscopic cholecystectomy is mainly due to carbon dioxide ( CO2 ) insufflation .


Various methods have been adopted to eliminate residual CO2 .


We compared the postoperative analgesic efficacy of intraperitoneal normal saline ( 30mL/kg ) irrigation with preoperative oral acetazolamide administration in patients undergoing laparoscopic cholecystectomy .


Sixty patients between 20 and 60 years of age were included in this prospective , randomized , double-blind study .


Patients in Group I received placebo , Group II patients received preoperative oral acetazolamide ( 5mg/kg ) , and Group III patients received intraperitoneal irrigation with 30mL/kg of normal saline .


Intravenous paracetamol ( 1g ) was administered every 6 hours for postoperative analgesia .


Parietal and visceral pain scores at rest , on movement , and on coughing and shoulder tip pain were recorded using a visual analog scale after arrival in the postanesthesia care unit , at 1 , 2 , 4 , 6 , 12 , and 24 hours after surgery .


Rescue analgesia was provided with an intravenous fentanyl ( 1g/kg ) bolus whenever the visual analog scale score was 4 .


Compared with Group I , Group III patients had significantly lower visceral pain scores at all time intervals except at 12 hours .


Group III patients also recorded significantly lower visceral pain scores than Group II from 2 to 24 hours .


There was no significant difference in shoulder tip pain .


The total dose of fentanyl used was significantly less in Group III .


Intraperitoneal normal saline irrigation is more effective than acetazolamide in reducing postoperative visceral pain after laparoscopic cholecystectomy and has significant opioid-sparing effect .


However , its effect on shoulder pain is comparable to that of acetazolamide .


Several hospitals in Norway provide short self-referral inpatient treatment to patients with severe mental diagnosis .


No studies have compared the experiences of patients who have had the opportunity to self-refer to inpatient treatment with patients who have received treatment as usual .


This qualitative study was nested within a randomised controlled trial investigating the effect of self-referral to inpatient treatment .


The aim was to explore how patients with severe mental diagnosis coped four months after signing a contract for self-referral , as compared to patients receiving treatment as usual .


Data was collected using qualitative individual interviews with patients with severe mental diagnosis , conducted four months after being randomised either to a contract for self-referral ( intervention group ) or to treatment as usual ( control group ) .


Twenty-five patients participated in interviews - 11 from the intervention group and 14 from the control group .


Results four months after randomisation showed that patients with a contract for self-referral appeared to have more confidence in strategies to cope with mental illness and to apply more active cognitive strategies .


Patients with a contract also expressed less resignation , hopelessness and powerlessness than patients without a contract .


In addition , patients with a contract seemed to be closer to the ideal of living a `` normal '' life and being a `` normal '' person .


The results indicate that the patients who had a contract for self-referral had come further in the recovery process and should possibly be better off during treatment .


Tramadol is used following neonatal cardiac and general surgery .


However , its ability to opioid-spare or facilitate earlier extubation in postoperative neonates is unquantified .


This randomized placebo-controlled trial aimed to assess whether tramadol 's addition to standard analgesia resulted in earlier extubation or reduced analgesic/sedative requirements in postsurgical neonates .


Neonates born 32 weeks postmenstrual age received either tramadol [ T ] 2 mgkg ( -1 ) or placebo [ P ] 6-hourly for up to 5 days postthoracoabdominal surgery in addition to morphine ( commenced at 20 mcgkg ( -1 ) h ( -1 ) ) and 6-hourly i.v. acetaminophen .


Time to extubation , morphine and midazolam amounts , hourly pain scores , and seizure activity were compared using an intention-to-treat and per-protocol analysis .


Seventy-one neonates participated .


Median survival time to extubation was similar between the groups ( T 67 h [ 95 % CI 51 , 84 ] vs P 52 h [ 95 % CI 43 , 65 ] ; P = 0.4 ) , and similar numbers were extubated by 96 h ( T 69 % vs P 77 % ; difference -8 % , 95 % CI -28 , 13 % ) .


Morphine and midazolam exposure was similar , with low pain scores in both groups ( mean percentage of time with a pain score > 5/20 during the 5 days : T 13 % vs P 11 % , difference in means 2.8 [ 95 % CI -1.8 , 7.6 ] , P = 0.20 ) .


Most participants had normal cranial ultrasounds ( T 86 % vs P 86 % ) ; no seizures occurred clinically or electroencephalographically .


Tramadol 's addition to standard analgesia in this small group of postsurgical neonates did not appear to have any positive effect on time to extubation , morphine or midazolam exposure , or pain scores .


This questions the benefit of tramadol for postsurgical neonates .


Importantly , no seizures occurred in these ill neonates who may potentially be at greater risk of tramadol toxicity compared with adults .


To assess the efficacy and safety of three different Chinese medical principles in treating patients with male infertility ( oligospermia/asthenozoospermia ) .


Totally 128 patients with male infertility were classified into 3 groups , i.e. , Shen-essence deficiency syndrome , Pi-Shen deficiency syndrome , Shen-deficiency blood-stasis syndrome .


They were assigned to the Chinese medical treatment group ( 96 cases ) and the Western medical treatment group ( 32 cases ) by stratified randomization in the ratio of 3 : 1 .


Those in the Chinese medical treatment group were treated with Chinese drugs for Shen invigorating and blood activating , Shen invigorating and Pi supplementing , Shen-qi benefiting .


Those in the Western medical treatment group were treated with Clomifene ( at the daily dose of 25 mg per day , once daily ) .


Three months consisted of one therapeutic course .


The parameters of semen , the pregnancy rate , and adverse reactions were observed .


Totally 24 patients dropped out in the two group , 17 in the Chinese medical treatment group ( 9 patients of Shen deficiency blood stasis syndrome , 5 of Shen-Pi deficiency syndrome , and 3 of Shen-essence deficiency syndrome ) and 7 in the Western medical treatment group .


Compared with before treatment , there was no statistical difference in the improvement of semen amount at 3 months after treatment between the two groups ( P > 0.05 ) .


There was statistical difference in the improvement of semen density , class A semen , class A + B semen , and 1-h activity ratio ( P < 0.05 ) .


The improvement was most obvious in Shen deficiency blood stasis syndrome , followed by Shen-Pi deficiency syndrome and Shen-essence deficiency syndrome .


The improvement was the weakest in the Western medical treatment group .


There was no statistical difference in the improvement of semen amount , semen density , class A semen , or 1-h activity ratio at 3 months after treatment between the two groups ( P > 0.05 ) .


Best effect was obtained in improving class A + B semen quality in patients of Shen deficiency blood stasis syndrome , showing statistical difference when compared with the other two syndrome types and the Western medical treatment group ( P < 0.05 , P < 0.01 ) .


No obvious adverse reaction occurred in the two groups during the treatment course .


Shen invigorating and blood activating method could improve the semen density and semen activities , and it was superior to other therapeutic methods .


To estimate the association of obesity and extreme obesity with maternal complications after cesarean delivery .


This was a secondary cohort analysis of a randomized controlled trial .


The parent study was designed to estimate the effect of supplemental oxygen on postcesarean infectious morbidity .


Because the study intervention had no effect , study groups were combined as a cohort .


For this secondary analysis , the exposure was obesity , stratified as normal or overweight ( body mass index [ BMI ] less than 30 ) , obese ( BMI 30-45 ) , or extremely obese ( BMI higher than 45 ) .


The primary outcome was a composite of wound infection and endometritis .


Secondary outcomes included wound infection , endometritis , wound opening , hematoma or seroma , and emergency department visit .


We performed unadjusted and multivariable logistic regression analyses .


Adjusted odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) are reported .


We included 585 women in the analysis .


Eighty-five patients ( 14.5 % ) had BMIs higher than 45 .


Rates of black race , chronic hypertension , diabetes , and gestational diabetes increased and operative duration increased with increasing obesity severity .


Obese patients were more likely to have a cesarean delivery after labor and have a vertical skin incision or classical uterine incision .


After controlling for confounders , extremely obese patients had a twofold to fourfold increase in postoperative complications , including the primary infectious outcome ( 18.8 % , adjusted OR 2.7 , CI 1.2-6 .1 ) , wound infection ( 18.8 % , adjusted OR 3.4 , CI 1.4-8 .0 ) , and emergency department visit ( 23.1 % , adjusted OR 2.2 , CI 1.03-4 .9 ) .


Maternal extreme obesity is associated with a considerable increase in postcesarean wound complications .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00602603 .


II .


This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon ( DCB ) coated with 2 g/mm ( 2 ) paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions .


Percutaneous treatment of peripheral vascular disease is associated with a high recurrence .


Paclitaxel-coated balloons at 3 g/mm ( 2 ) formulated differently have shown promising results with reduced restenosis .


Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB ( n = 49 ) versus uncoated balloons ( control group [ n = 52 ] ) , stratified by whether balloon-only treatment ( n = 75 ) or stenting ( n = 26 ) was intended .


The primary endpoint was angiographic late lumen loss at 6 months .


Secondary outcomes included adjudicated major adverse events ( death , amputation , target lesion thrombosis , reintervention ) , functional outcomes , and pharmacokinetics .


Demographic , peripheral vascular disease , and lesion characteristics were matched , with mean lesion length of 8.1 3.8 cm and 42 % total occlusions .


At 6 months , late lumen loss was 58 % lower for the Lutonix DCB group ( 0.46 1.13 mm ) than for the control group ( 1.09 1.07 mm ; p = 0.016 ) .


Composite 24-month major adverse events were 39 % for the DCB group , including 15 target lesion revascularizations , 1 amputation , and 4 deaths versus 46 % for uncoated balloon group , with 20 target lesion revascularizations , 1 thrombosis , and 5 deaths .


Pharmacokinetics showed biexponential decay with peak concentration ( Cmax ) of 59 ng/ml and total observed exposure ( AUC ( all ) ) of 73 ng h/ml .


For successful DCB deployment excluding 8 malfunctions , 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24 % .


Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty .


( LEVANT I , The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis ; NCT00930813 )


Since protein ingestion is known to stimulate the secretion of glucagon-like peptide-1 ( GLP-1 ) , we hypothesised that enhancing GLP-1 secretion to harness its insulinotropic/beta cell-stimulating activity with whey protein pre-load may have beneficial glucose-lowering effects in type 2 diabetes .


In a randomised , open-label crossover clinical trial , we studied 15 individuals with well-controlled type 2 diabetes who were not taking any medications except for sulfonylurea or metformin .


These participants consumed , on two separate days , 50 g whey in 250 ml water or placebo ( 250 ml water ) followed by a standardised high-glycaemic-index breakfast in a hospital setting .


Participants were randomised using a coin flip .


The primary endpoints of the study were plasma concentrations of glucose , intact GLP-1 and insulin during the 30 min following meal ingestion .


In each group , 15 patients were analysed .


The results showed that over the whole 180 min post-meal period , glucose levels were reduced by 28 % after whey pre-load with a uniform reduction during both early and late phases .


Insulin and C-peptide responses were both significantly higher ( by 105 % and 43 % , respectively ) with whey pre-load .


Notably , the early insulin response was 96 % higher after whey .


Similarly , both total GLP-1 ( tGLP-1 ) and intact GLP-1 ( iGLP-1 ) levels were significantly higher ( by 141 % and 298 % , respectively ) with whey pre-load .


Dipeptidyl peptidase 4 plasma activity did not display any significant difference after breakfast between the groups .


In summary , consumption of whey protein shortly before a high-glycaemic-index breakfast increased the early prandial and late insulin secretion , augmented tGLP-1 and iGLP-1 responses and reduced postprandial glycaemia in type 2 diabetic patients .


Whey protein may therefore represent a novel approach for enhancing glucose-lowering strategies in type 2 diabetes .


Trial registration ClinicalTrials.gov NCT01571622 Funding The Israeli Ministry of Health and Milk Council funded the research .


To determine if indomethacin has a positive clinical effect for the prophylaxis of heterotopic ossification ( HO ) after acetabular fracture surgery .


To determine whether indomethacin affects the union rate of acetabular fractures .


Prospective randomized double-blinded trial .


Level 1 regional trauma center .


Skeletally mature patients treated operatively for an acute acetabular fracture through a Kocher-Langenbeck approach .


Patients were randomly allocated to 1 of 4 groups comparing placebo ( group 1 ) to 3 days ( group 2 ) , 1 week ( group 3 ) , and 6 weeks ( group 4 ) of indomethacin treatment .


Factors analyzed included the overall incidence , Brooker class and volume of HO , radiographic union of the acetabular fracture , and pain .


Patients were followed clinically and radiographically at 6 weeks , 3 months , 6 months , and 1 year .


Serum levels of indomethacin were drawn at 1 month to assess compliance .


Computed tomographic scans were performed at 6 months to assess healing and volume of HO .


Ninety-eight patients were enrolled into this study , 68 completed the follow-up and had the 6-month computed tomographic scan , and there was a 63 % compliance rate with the treatment regimen .


Overall incidence of HO was 67 % for group 1 , 29 % for group 2 ( P = 0.04 ) , 29 % for group 3 ( P = 0.019 ) , and 67 % for group 4 .


The volume of HO formation was 17,900 mm for group 1 , 33,800 mm for group 2 , 6300 mm for group 3 ( P = 0.005 ) , and 11,100 mm for group 4 .


The incidence of radiographic nonunion was 19 % for group 1 , 35 % for group 2 , 24 % for group 3 , and 62 % for group 4 ( P = 0.012 ) .


Seventy-seven percent of the nonunions involved the posterior wall segment .


Pain visual analog scores ( VASs ) were significantly higher for patients with radiographic nonunion ( VAS 4 vs. VAS 1 , P = 0.002 ) .


Treatment with 6 weeks of indomethacin does not appear to have a therapeutic effect for decreasing HO formation after acetabular fracture surgery and appears to increase the incidence of nonunion .


Treatment with 1 week of indomethacin may be beneficial for decreasing the volume of HO formation without increasing the incidence of nonunion .


Therapeutic Level II .


See Instructions for Authors for a complete description of levels of evidence .


To compare efficacy and complications of partially covered self-expandable metal stent ( pcSEMS ) to plastic stent ( PS ) in patients treated for malignant , infrahilar biliary obstruction .


Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent ( ) ( SEMS ) or a 10 French PS .


Palliative patients aged 18 , for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60 % from 6 participating North American university centers .


Primary endpoint was time to stent failure , with secondary outcomes of death , adverse events , Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years .


Survival analyses were performed for stent failure and death , with Cox proportional hazards regression models to determine significant predictive characteristics .


Eighty-five patients were accrued over 37 mo , 42 were randomized to the SEMS group and 83 patients were available for analyses .


Time to stent failure was 385.3 52.5 d in the SEMS and 153.3 19.8 d in the PS group , P = 0.006 .


Time to death did not differ between groups ( 192.3 23.4 d for SEMS vs 211.5 28.0 d for PS , P = 0.70 ) .


The only significant predictor was treatment allocation , relating to the time to stent failure ( P = 0.01 ) .


Amongst other measured outcomes , only cholangitis differed , being more common in the PS group ( 4.9 % vs 24.5 % , P = 0.029 ) .


The small number of patients in follow-up limits longitudinal assessments of performance and quality of life .


From an initially planned 120 patients , only 85 patients were recruited .


Partially covered SEMS result in a longer duration till stent failure without increased complication rates , yet without accompanying measurable benefits in survival , performance , or quality of life .


In this 2-site randomized trial , we investigated the effect of antiseptic drain care on bacterial colonization of surgical drains and infection after immediate prosthetic breast reconstruction .


With IRB approval , we randomized patients undergoing bilateral mastectomy and reconstruction to drain antisepsis ( treatment ) for one side , with standard drain care ( control ) for the other .


Antisepsis care included both : chlorhexidine disc dressing at drain exit site ( s ) and irrigation of drain bulbs twice daily with dilute sodium hypochlorite solution .


Cultures were obtained from bulb fluid at 1 week and at drain removal , and from the subcutaneous drain tubing at removal .


Positive cultures were defined as 1 + growth for fluid and > 50 CFU for tubing .


Cultures of drain bulb fluid at 1 week ( the primary endpoint ) were positive in 9.9 % of treatment sides ( 10 of 101 ) versus 20.8 % ( 21 of 101 ) of control sides ( p = 0.02 ) .


Drain tubing cultures were positive in 0 treated drains versus 6.2 % ( 6 of 97 ) of control drains ( p = 0.03 ) .


Surgical site infection occurred within 30 days in 0 antisepsis sides versus 3.8 % ( 4 of 104 ) of control sides ( p = 0.13 ) , and within 1 year in three of 104 ( 2.9 % ) of antisepsis sides versus 6 of 104 ( 5.8 % ) of control sides ( p = 0.45 ) .


Clinical infection occurred within 1 year in 9.7 % ( 6 of 62 ) of colonized sides ( tubing or fluid ) versus 1.5 % ( 2 of 136 ) of noncolonized sides ( p = 0.03 ) .


Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains , and reduced drain colonization was associated with fewer infections .


Providing consistent levels of oxygen saturation ( SpO2 ) for infants in neonatal intensive care units is not easy .


This study explored how effectively the Auto-Mixer ( ) algorithm automatically adjusted fraction of inspired oxygen ( FiO2 ) levels to maintain SpO2 within an intended range in extremely low birth weight infants receiving supplemental oxygen without mechanical ventilation .


Twenty extremely low birth weight infants were randomly assigned to the Auto-Mixer ( ) group or the manual intervention group and studied for 12h .


The SpO2 target was 85-93 % , and the outcomes were the percentage of time SpO2 was within target , SpO2 variability , SpO2 > 95 % , oxygen received and manual interventions .


The percentage of time within intended SpO2 was 584 % in the Auto-Mixer ( ) group and 33.74.7 % in the manual group , SpO2 > 95 % was 26.5 % vs 54.8 % , average SpO2 and FiO2 were 89.8 % vs 92.2 % and 37 % vs 44.1 % , and manual interventions were 0 vs 80 ( p < 0.05 ) .


Brief periods of SpO2 < 85 % occurred more frequently in the Auto-Mixer ( ) group .


The Auto-Mixer ( ) effectively increased the percentage of time that SpO2 was within the intended target range and decreased the time with high SpO2 in spontaneously breathing extremely low birth weight infants receiving supplemental oxygen .


This post hoc analysis examined the effects of adalimumab in patients with scalp and/or nail psoriasis from BELIEVE ( a randomized , controlled , multicentre phase 3 safety and efficacy trial ) .


Efficacy was assessed in the pooled treatment group ( adalimumab with or without calcipotriol plus betamethasone dipropionate ) by Psoriasis Area and Severity Index ( 75 % improvement ; PASI 75 ) , Psoriasis Scalp Severity Index ( PSSI ) , Nail Psoriasis Severity Index ( NAPSI ) , Dermatology Life Quality Index ( DLQI ) and a visual analog scale ( VAS ) for pain .


Of the 730 enrolled patients , 663 ( 91.3 % ) , 457 ( 63.1 % ) and 433 ( 60.1 % ) had psoriasis of the scalp , nails , or both , respectively .


Similar proportions of patients with ( 68.2 % ) and without ( 63.5 % ) scalp involvement achieved a PASI 75 response at week 16 [ adjusted odds ratio ( OR ) , 1.34 ; P = 0.320 ] .


PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 ( 53.0 % vs. 62.9 % ; OR , 0.68 ; P = 0.019 ) and week 16 ( 65.0 % vs. 73.0 % ; OR , 0.70 ; P = 0.052 ) .


PASI 75 response rates were 66.1 % in patients with scalp and nail involvement and 70.8 % in patients without both scalp and nail involvement at week 16 ( OR , 0.87 ; P = 0.423 ) .


Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study .


Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median ( meanSD ) decrease from baseline PSSI at week 16 of 100 % ( 77.296.9 % ) .


Patients with nail psoriasis improved , demonstrated by a median ( meanSD ) decrease from baseline NAPSI at week 16 of 39.5 % ( 9.4164.5 % ) .


Our results indicate that adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement .


In addition , similar PASI 75 response rates are achieved in patients with and without scalp involvement , whereas patients with nail involvement demonstrate a moderate ( perhaps delayed ) PASI 75 response rate .


Anticoagulation before , during , and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation .


The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily ( 15 mg if creatinine clearance is 30-49 mL/min ) compared with dose-adjusted vitamin K antagonists ( VKAs ; international normalized ratio 2.0-3 .0 ) in patients scheduled for elective cardioversion .


This is a prospective , randomized , open-label , parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of > 48 hours or unknown duration .


Patients will be randomized 2:1 ( rivaroxaban : VKA ) using 2 cardioversion strategies : the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy ( heparin + VKA ) .


In these patients , transesophageal echocardiography will be encouraged to exclude atrial thrombi .


The alternative approach is delayed cardioversion .


Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion .


All patients will receive study treatment for 6 weeks postcardioversion .


The primary efficacy end point is a composite of all strokes , transient ischemic attacks , noncentral nervous system systemic emboli , myocardial infarctions , and cardiovascular deaths .


Each primary end point component will be evaluated separately , and additional composites will be investigated .


The principal safety end point is major bleeding .


This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion .


It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population .


Although the potential benefits of stereoscopic laparoscopy have been recognized for years , the technology has not been adopted because of poor operator tolerance .


Passive polarizing projection systems , which have revolutionized three-dimensional ( 3D ) cinema , are now being trialled in surgery .


This study was designed to see whether this technology resulted in significant performance benefits for skilled laparoscopists .


Four validated laparoscopic skills tasks , each with ten repetitions , were performed by 20 experienced laparoscopic surgeons , in both two-dimensional ( 2D ) and 3D conditions .


The primary outcome measure was the performance error rate ; secondary outcome measures were time for task completion , 3D motion tracking ( path length , motion smoothness and grasping frequency ) and workload dimension ratings of the National Aeronautics and Space Administration ( NASA ) Task Load Index .


Surgeons demonstrated a 62 per cent reduction in the median number of errors and a 35 per cent reduction in median performance time when using the passive polarizing 3D display compared with the 2D display .


There was a significant 15 per cent reduction in median instrument path length , an enhancement of median motion smoothness , and a 15 per cent decrease in grasper frequency with the 3D display .


Participants reported significant reductions in subjective workload dimension ratings of the NASA Task Load Index following use of the 3D displays .


Passive polarizing 3D displays improved both the performance of experienced surgeons in a simulated setting and surgeon perception of the operative field .


Although it has been argued that the experience of skilled laparoscopic surgeons compensates fully for the loss of stereopsis , this study indicates that this is not the case .


Surgical relevance The potential benefits of stereoscopic laparoscopy have been known for years , but the technology has not been adopted because of poor operator tolerance .


The first laparoscopic operation was carried out using a prototype passive polarizing laparoscopic system in 2010 .


This is new three-dimensional ( 3D ) technology offers a real option for 3D laparoscopic surgery where previous systems have failed .


This study is the first to have been carried out using this technology .


It is essential that new technologies are adopted only when there is robust evidence to support their use .


Currently , there are concerns about the use of robotic technologies and whether advantages exist for patient care .


If there are advantages , 3D must be playing a significant role .


If so , perhaps the technology under investigation here offers potential to a greater spectrum of surgeons , as well as being a more affordable option .


To identify the effect of some herbal products on insulin resistance .


Regarding the scientific evidences existing about ginger , this research was therefore carried out to identify the effect of ginger supplementation on insulin resistance and glycemic indices in diabetes mellitus .


This is a randomized , double-blind , placebo-controlled trial in which 88 participants affected by diabetes were randomly assigned into ginger ( GG ) and placebo ( PG ) groups .


The GG received 3 one-gram capsules containing ginger powder whereas the PG received 3 one-gram microcrystalline-containing capsules daily for 8 weeks .


HbA1c , fructosamine , fasting blood sugar ( FBS ) , fasting insulin , homeostasis model assessment insulin resistance index ( HOMA-IR ) , - cell function ( % ) , insulin sensitivity ( S % ) and the quantitative insulin sensitivity check index ( QUICKI ) were assessed before and after the intervention .


FBS mean showed a decrease of 10.5 % ( p = 0.003 ) in the GG whereas the mean had an increase of 21 % in the PG ( p = 0.01 ) .


Variation in HbA1c mean was in line with that of FBS .


Statistical difference was found in the two groups before and after the intervention in terms of median of fasting insulin level , S % and HOMA-IR ( P < 0.005 ) .


Moreover QUICKI mean increased significantly in the two groups , the mean difference , however , was significantly higher in the GG .


The study demonstrated that daily consumption of 3 one-gram capsules of ginger powder for 8 weeks is useful for patients with type 2 diabetes due to FBS and HbA1c reduction and improvement of insulin resistance indices such as QUICKI index .


To study the presence of bacterial biofilm on the sinus mucosa of healthy individuals ( controls ) and patients with chronic rhinosinusitis with or without nasal polyposis .


An analytical , prospective and observational study was conducted .


Tissue samples were obtained from the sinus mucosa .


The bacteria were isolated and typified , and the material was examined for biofilm formation using tissue culture plate , Congo red agar detection and tube methods .


A total of 100 cases were analysed for the presence of biofilm .


Bacterial biofilm was present in 26 of 50 disease group cases ( 52 per cent ) and in 4 of 50 control group cases ( 8 per cent ) ( p < 0.01 ) .


The presence of biofilm on the mucosa of chronic rhinosinusitis patients offers a possible cause for the persistent inflammation , and for antibiotics resistance and antimicrobial therapy failure .


These findings could change the approach to treatment .


We studied the characteristics and clinical outcome related to diuretic response and the effects of serelaxin in patients hospitalized for acute heart failure ( AHF ) .


RELAX-AHF was a double-blind , placebo-controlled trial , enrolling 1161 patients admitted to hospital for AHF who were randomized to 48 h i.v infusions of placebo or serelaxin ( 30 g/kg per day ) within 16 h from presentation .


Diuretic response was defined as weight kg / [ ( total i.v. dose ) / 40 mg ] + [ ( total oral dose ) / 80 mg ) ] furosemide ( or equivalent loop diuretic dose ) up to day 5 .


Median diuretic response was -0.42 ( -1.00 , -0.14 ) kg/40 mg .


A poor diuretic response was independently associated with Western-like region ( Western Europe , North America , Israel , and Poland ) , lower diastolic blood pressure , the absence of oedema , higher blood urea nitrogen , and lower levels of aspartate aminotransferase and potassium ( all P < 0.01 ) .


Randomization to serelaxin was associated with lower doses of i.v. loop diuretics and slightly less weight loss , resulting in a neutral effect on diuretic response .


Worse diuretic response was independently associated both with less relief of dyspnoea , measured with a visual analogue scale ( VAS ) at day 5 ( primary endpoint ; P = 0.0002 ) , and with a higher risk of cardiovascular death or rehospitalization for heart failure or renal failure through day 60 ( secondary endpoint , P < 0.0001 ) , but not with increased 180-day cardiovascular mortality ( P = 0.507 ) .


In patients hospitalized for AHF , a poor diuretic response was associated with a poor in-hospital and early post-discharge clinical outcome .


Serelaxin had a neutral effect on diuretic response .


NCT00520806 .


To compare the therapeutic effect of probiotics and oral immunoglobulin on pediatric rotavirus enteritis .


A randomized , controlled trial was conducted in 150 children with rotavirus enteritis who were randomly divided into control , probiotic and immunoglobulin groups ( n = 50 each ) .


In addition to basic treatment , the control group was given placebo , the probiotic group was given live combined bifidobacterium and lactobacillus tablets , and the immunoglobulin group was orally given anti-rotavirus egg yolk immunoglobulin ( IgY ) .


Clinical symptoms such as stool frequency and stool properties were recorded every day .


Fresh stool samples were collected on days 1 , 3 , 5 , 7 , 9 and 11 of treatment .


Intestinal flora imbalance was detected and divided into three degrees by microscopic examination of stool .


Fecal SIgA level and fecal rotavirus shedding were measured by radioimmunoassay and double-antibody sandwich ELISA respectively .


Compared with the control group , the probiotic group had reduced intestinal flora imbalance , decreased stool frequency , and reduced incidence of secondary intestinal bacterial infection after 3 days of treatment ( P < 0.05 ) .


There was no significant difference in disease course between the probiotic and control groups .


Compared with the control group , the immunoglobulin group had a significantly increased fecal SIgA level after 1 day of treatment ( P < 0.05 ) , significantly decreased frequency of diarrhea and fecal rotavirus shedding after 3 days of treatment ( P < 0.05 ) , and a significantly shorter disease course ( 4.51.0 vs 5.81.7 days ; P < 0.05 ) .


For children with rotavirus enteritis , probiotics can reduce intestinal flora imbalance and prevent secondary intestinal bacterial infection , but probiotics take a long time to relieve clinical symptoms and can not shorten the course of disease .


Oral immunoglobulin takes effect quickly and can rapidly eliminate rotavirus , promote the production of SIgA , and shorten the course of disease .


Many patients with obsessive-compulsive disorder ( OCD ) do not receive first-line treatment according to the current guidelines ( cognitive behavioral therapy with exposure and response prevention , CBT with ERP ) due to barriers to treatment .


Internet-based therapy is designed to overcome these barriers .


The present study evaluates the efficacy of an Internet-based writing therapy with therapeutic interaction based on the concept of CBT with ERP for patients with OCD .


Thirty-four volunteers with OCD according to DSM-IV-criteria were included in the trial and randomized according to a waiting-list control design with follow-up measures at 8 weeks and 6 months .


The intervention consisted of 14 sessions , either starting directly after randomization or with an 8-week delay .


Main outcome measure was the change in the severity of OCD symptoms ( Yale-Brown Obsessive Compulsive Scale Self-Rating , Y-BOCS SR , and Obsessive-Compulsive Inventory-Revised , OCI-R ) .


Obsessive-compulsive symptoms were significantly improved in the treatment group compared to the waiting-list control group with large effect sizes of Cohen 's d = 0.82 ( Y-BOCS SR ) and d = 0.87 ( OCI-R ) , using an intention-to-treat analysis .


This effect remained stable at 6-month follow-up .


Only 4 participants ( 12 % ) dropped out prematurely from the study .


Of the 30 completers , 90 % rated their condition as improved and would recommend the program to their friends .


Internet-based writing therapy led to a significant improvement of obsessive-compulsive symptoms .


Even though replications with larger sample sizes are needed , the results support the notion that Internet-based approaches have the potential for improving the treatment situation for patients with OCD .


To evaluate whether subjects with knee or hip osteoarthritis ( OA ) pain on non-steroidal anti-inflammatory drugs ( NSAIDs ) received greater benefit when tanezumab monotherapy replaced or was coadministered with NSAIDs .


Subjects ( N = 2700 ) received intravenous tanezumab ( 5 or 10mg ) or placebo every 8weeks with or without oral naproxen 500mg twice daily or celecoxib 100mg twice daily .


Efficacy was assessed as change from baseline to week 16 in three co-primary endpoints : Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) Pain , WOMAC Physical Function and Patient 's Global Assessment ( PGA ) of OA .


Safety assessments included adverse events , physical and neurological examinations , laboratory tests and vital signs .


Although all tanezumab treatments provided significant improvements in WOMAC Pain and Physical Function over either NSAID alone , only tanezumab + NSAIDs were significant versus NSAIDs with PGA and met the prespecified definition of superiority .


Combination treatment did not substantially improve pain or function over tanezumab monotherapy .


Adverse event frequency was higher with tanezumab than with NSAIDs and highest with combination therapy .


Higher incidence of all-cause total joint replacements occurred with tanezumab + NSAID versus tanezumab monotherapy or NSAIDs .


Rapidly progressive OA incidence was significantly greater versus NSAID in all tanezumab groups except tanezumab 5mg monotherapy .


Subjects receiving partial symptomatic relief of OA pain with NSAIDs may receive greater benefit with tanezumab monotherapy .


While only coadministration of tanezumab with NSAIDs met the definition of superiority , combination treatment did not provide important benefits over tanezumab monotherapy ; small differences in efficacy were negated by treatment-limiting or irreversible safety outcomes .


NCT00809354 .


To explore the effect of auricular point sticking before operation for postoperative complications of external excision and internal ligation on mixed hemorrhoid .


Eighty patients with mixed hemorrhoid were randomly divided into an observation group and a control group , 40 cases in each group .


In the control group , paracetamol and dihydrocodeine tartrate tablets were applied with oral administration 1 h after operation , 510 mg each time , twice a day ; at the same time , diosmin tablets were treated with oral administration , 0.9 g each time , twice a day .


Three days ' treatments were required successively .


In the observation group , auricular point sticking was used before operation based on the treatment in the control group .


The auricular points of Shen ( Co10 ) , Pangguang ( CO9 ) , Shenmen ( TF4 ) , Pizhixia ( AT4 ) , Jiaogan ( AH6a ) and Gangmen ( HX5 ) were selected .


The patients were asked to press the points 3-6 times per day , 3-5 min each time , 3 days ' treatment in total .


The scores of the postoperative complications in the 1st and the 2nd days were compared between the two groups such as pain , edema , hematochezia , retention of urine , etc. .


After operation , the scores of pain , edema , hematochezia , retention of urine in the 2nd day were all decreased obviously than those in the 1st day in the two groups ( all P < 0.05 ) ; and the scores of pain , edema , hematochezia , retention of urine in the 1st and the 2nd days of the observation group were lower than those in the control group ( all P < 0.05 ) .


Auricular point sticking before operation combined with conventional western medicine with oral administration for preventing and treating postoperative complications of external excision and internal ligation on mixed hemorrhoid achieves positive and reliable efficacy .


Providing restorative treatment for persons with disability may be challenging and has been related to the patient 's ability to cope with the anxiety engendered by treatment and to cooperate fully with the demands of the clinical situation .


The aim of the present study was to assess the survival rate of ART restorations compared to conventional restorations in people with disability referred for special care dentistry .


Three treatment protocols were distinguished : ART ( hand instruments/high-viscosity glass-ionomer ) ; conventional restorative treatment ( rotary instrumentation/resin composite ) in the clinic ( CRT/clinic ) and under general anaesthesia ( CRT/GA ) .


Patients were referred for restorative care to a special care centre and treated by one of two specialists .


Patients and/or their caregivers were provided with written and verbal information regarding the proposed techniques , and selected the type of treatment they were to receive .


Treatment was provided as selected but if this option proved clinically unfeasible one of the alternative techniques was subsequently proposed .


Evaluation of restoration survival was performed by two independent trained and calibrated examiners using established ART restoration assessment codes at 6 months and 12 months .


The Proportional Hazard model with frailty corrections was applied to calculate survival estimates over a one year period .


66 patients ( 13.67.8 years ) with 16 different medical disorders participated .


CRT/clinic proved feasible for 5 patients ( 7.5 % ) , the ART approach for 47 patients ( 71.2 % ) , and 14 patients received CRT/GA ( 21.2 % ) .


In all , 298 dentine carious lesions were restored in primary and permanent teeth , 182 ( ART ) , 21 ( CRT/clinic ) and 95 ( CRT/GA ) .


The 1-year survival rates and jackknife standard error of ART and CRT restorations were 97.81.0 % and 90.53.2 % , respectively ( p = 0.01 ) .


These short-term results indicate that ART appears to be an effective treatment protocol for treating patients with disability restoratively , many of whom have difficulty coping with the conventional restorative treatment .


Netherlands Trial Registration : NTR 4400 .


To assess the effects of different nasal continuous positive airway pressure ( nCPAP ) pressures on cardiac performance in preterm infants with minimal lung disease , we conducted a randomized , blinded crossover study .


We studied infants between 28 and 34 weeks ' corrected gestational age , treated with nCPAP of 5cm H2O , in air .


Infants with significant cardiac shunts were excluded .


Infants were randomly assigned to nCPAP levels of 4 , 6 , and 8 cm H2O for 15 minutes each .


Right and left ventricular outputs and left pulmonary artery and superior vena cava flows were measured 15 minutes after each change .


Thirty-four infants born at a mean gestational age of 29 weeks with a birth weight of 1.3 kg were studied .


There were no significant differences in right and left ventricular outputs and left pulmonary artery and superior vena cava flows at different levels of nCPAP .


We investigated the effect of increasing nCPAP levels on cardiac output .


We conclude that nCPAP levels between 4 and 8 cm H2O did not have an effect on cardiac output in stable preterm infants with minimal lung disease .


Low and high dialysate calcium ( Ca ) content may have positive and harmful effects depending on the considered pathological aspect : hemodynamic instability , cardiac arrhythmias , parathormone release , adynamic bone disease , cardio-vascular calcifications .


We hypothesized that a time-profiled Ca concentration would keep the cardiovascular advantages of high Ca but would reduce the risk of calcium overload .


A prospective , multicenter study using a particular hemodiafiltration technique that allows the profiling of electrolytes was designed .


Patients ( n = 22 ) underwent randomly a 3-week dialysis session with low and high constant dialysate Ca ( Ld ( Ca , ) , 1.25 mM and Hd ( Ca , ) , 2 mM ) and profiled Ca ( Pd ( Ca ) ) , respectively .


Plasma and spent dialysate Ca , systolic and diastolic arterial pressure ( SAP , DAP ) and QT interval corrected for heart rate ( QTc ) were analyzed .


Plasma Ca concentration decreased in Ld ( Ca ) , whereas it increased in Hd ( Ca ) and to a lesser extent , in Pd ( Ca ) .


Total amount of Ca given to the patient in Pd ( Ca ) ( 15.5 1.0 mmol ) was higher than in Ld ( Ca ) ( 4.3 1.6 mmol ) but lower than in Hd ( Ca ) ( 21.9 3.3 mmol ) .


SAP and DAP decreased in Ld ( Ca ) , whereas it was almost constant in both Hd ( Ca ) and Pd ( Ca ) .


QTc significantly increased , up to critical values ( > 460 msec ) , only during Ld ( Ca ) .


Pd ( Ca ) seems to retain the advantages of high Ca in terms of hemodynamic stability and modification of QTc while reducing the excessive positive calcium balance typical of dialysis with high Ca content .


Sedentary behavior is regarded as a distinct risk factor for cardiometabolic morbidity and mortality , but knowledge of the efficacy of interventions targeting reductions in sedentary behavior is limited .


To investigate the effect of an individualized face-to-face motivational counseling intervention aimed at reducing sitting time .


A randomized , controlled , observer-blinded , community-based trial with two parallel groups using open-end randomization with 1:1 allocation .


A total of 166 sedentary adults were consecutively recruited from the population-based Health2010 Study .


Participants were randomized to a control ( usual lifestyle ) or intervention group with four individual theory-based counseling sessions .


Objectively measured overall sitting time ( ActivPAL 3TM , 7 days ) ; secondary measures were breaks in sitting time , anthropometric measures , and cardiometabolic biomarkers , assessed at baseline and after 6 months .


Data were collected in 2010-2012 and analyzed in 2013-2014 using repeated measures multiple regression analyses .


Ninety-three participants were randomized to the intervention group and 73 to the control group , and 149 completed the study .


The intervention group had a mean sitting time decrease of -0.27 hours/day , corresponding to 2.9 % of baseline sitting time ( hours/day ) ; the control group increased mean sitting time by 0.06 hours/day .


The between-group difference in change , -0.32 hours/day ( 95 % CI = -0.87 , 0.24 , p = 0.26 ) , was not statistically significant .


Significant differences in change in fasting serum insulin of -5.9 pmol/L ( 95 % CI = -11.4 , -0.5 , p = 0.03 ) ; homeostasis model assessment-estimated insulin resistance of -0.28 ( 95 % CI = -0.53 , -0.03 , p = 0.03 ) ; and waist circumference of -1.42 cm ( 95 % CI = -2.54 , -0.29 , p = 0.01 ) were observed in favor of the intervention group .


Although the observed decrease in sitting time was not significant , a community-based , individually tailored , theory-based intervention program aimed at reducing sitting time may be effective for increasing standing and improving cardiometabolic health in sedentary adults .


This study is registered at Clinicaltrials.gov ( NCT00289237 ) .


Cirrhosis of liver is the leading cause of portal hypertension in this part of the globe .


Around thirty percent of the patient with portal hypertension develops complications .


Oesophageal variceal bleeding is a serious complication of portal hypertension .


Oesophageal variceal band ligation ( EVBL ) has become the standard of care for patients with bleeding oesophageal varices .


Multiple sessions of band ligation are cumbersome and expensive .


Sixty patients with acute variceal bleed were enrolled in this randomized control trial .


Patients were randomly assigned to multi-session ( group A ) or single session ( group B ) oesophageal variceal band ligation group .


All .


patients were followed for re-bleeding and mortality up to three months .


Re-bleeding occurred ( 20 % ) in group A and ( 17 % ) in group B patients , respectively .


Mortality was 10 % in group A and 7 % in group B patients .


Variceal obliteration was better in group A 63 % than group B 24 % ( p < 0.05 ) .


Single session band ligation was comparable for rates of re-bleeding and mortality to multi-session band ligation .


Cardiovascular disease ( CVD ) is a common problem of middle-aged and older adults .


Increased arterial stiffness is a CVD risk factor .


Whole-body vibration ( WBV ) is a simple and convenient exercise for middle-aged and older adults ; however , there have been few studies investigating the effect of WBV on arterial stiffness .


This study mainly investigated the effect of WBV on arterial stiffness in middle-aged and older adults .


A total of 38 ( 21 women and 17 men ) middle-aged and elderly subjects ( average age , 61.9 years ) were randomly divided into the WBV group and the control group for a 3-month trial .


The WBV group received an intervention of 30 Hz and 3.2 g WBV in a natural full standing posture at a sports center .


The brachial-ankle pulse wave velocity ( baPWV ) , a marker of systemic arterial stiffness , and blood pressure and heart rate were measured before and after the intervention .


After 3 months , there were no significant changes in blood pressure or heart rate in both groups .


However , the bilateral baPWV was significantly reduced in the WBV group ( decreased by 0.65 m/second [ P = 0.014 ] ; 0.63 m/second [ P = 0.041 ] in either side ) , but not in the control group .


The comparison between the two groups was not statistically significant .


This study found that 3 months of WBV had a positive effect on arterial stiffness in middle-aged and older adults and could therefore be regarded as a supplementary exercise .


Larger-scale studies are needed to confirm the effects of WBV in the future .


To determine whether haemoperfusion ( HP ) with continuous venovenous haemofiltration ( CVVH ) improves the survival of patients with acute paraquat poisoning , compared with those treated using HP alone .


Medical records of patients with acute paraquat poisoning were analysed .


Patients were randomised to undergo HP or HP + CVVH within 24 h of paraquat ingestion .


Mortality rate , survival duration and cause of death were recorded .


There were no significant differences in mortality rate between the HP group ( n = 458 ) and the HP + CVVH group ( n = 226 ) ( 57.4 % and 58.4 % , respectively ) .


The mean survival duration was significantly longer in the HP + CVVH group than the HP group ( 8.6 3.1 and 5.1 2.3 days , respectively ) .


Early circulatory collapse was a major cause of death in the HP group .


The major cause of death in the HP + CVVH group was late respiratory failure .


Combined therapy with HP and CVVH can prevent early death and prolong survival duration following acute paraquat poisoning , providing the opportunity for further treatment .


To compare the safety and efficiency of thulium laser resection of the prostate-tangerine technique ( TmLRP-TT ) and plasmakinetic resection of the prostate ( PKRP ) for aged symptomatic benign prostatic hyperplasia ( BPH ) patients with large volume prostates ( > 80 ml ) in a prospective randomized trial with an 18-month follow-up .


From January 2010 to November 2011 , 90 BPH patients with large volume prostates were randomized for surgical treatment with TmLRP-TT ( n = 45 , group 1 ) or PKRP ( n = 45 , group 2 ) .


The preoperative and postoperative parameters were recorded and compared .


All patients were evaluated at 1 , 6 , 12 and 18 months postoperatively using the International Prostate Symptom Score ( IPSS ) , quality of life score ( QoL ) , maximum flow rate ( Q max ) , postvoid residual urine volume ( PVR ) and the five-item version of the International Index of Erectile Function score .


All perioperative complications were also documented and classified according to the modified Clavien classification system .


Compared with the PKRP group , the TmLRP-TT group had a statistically lower hemoglobin drop ( 0.86 0.42 vs. 1.34 1.04 g/dl , P < 0.01 ) , shorter catheterization time ( 1.91 0.85 vs. 2.36 0.74 days , P < 0.01 ) and hospital stay ( 3.80 0.46 vs. 5.02 0.54 days , P < 0.01 ) .


Within the observation period of 18 months , both groups had significant postoperative improvement in IPSS , QoL , Q max and PVR , although no difference was observed between the two groups .


Only one patient receiving PKRP treatment required a blood transfusion perioperatively .


During the 18-month follow-up , one patient in each group experienced urethral stricture and one patient in the PKRP group experienced bladder neck contracture .


Minor complications that required no or noninterventional treatment occurred in 6 ( 13.33 % ) of TmLRP-TT group ( Clavien grade 1 , 13.33 % and grade 2 , 0 % ) and 10 ( 22.22 % ) of PKRP group ( Clavien grade 1 , 20.00 % and grade 2 , 2.22 % ) .


No severe complications required reinterventions in both groups ( Clavien grade 3 , 0 % ; grade 4 , 0 % ; grade 5 , 0 % ) .


Both TmLRP-TT and PKRP are safe and effective treatment options for large prostates that require resection .


Taking into account less blood loss , shorter catheterization time and hospital stay , TmLRP-TT may be a better treatment for patients with large prostates .


To evaluate whether 6 mm long by 4 mm wide dental implants could be an alternative to implants at least 10 mm long placed in bone augmented with bone substitutes in posterior atrophic jaws .


A total of 20 patients with bilateral atrophic mandibles and 20 patients with bilateral atrophic maxillae , having 5 to 7 mm of bone height above the mandibular canal or below the maxillary sinus , had each side of the jaws randomly allocated according to a split-mouth design .


They were allocated to receive one to three 6 mm long and 4 mm wide implants , or implants at least 10 mm long in augmented bone by two different surgeons in different centres .


Mandibles were vertically augmented with interpositional equine bone blocks and resorbable barriers , and implants were placed 3 months later .


Maxillary sinuses were augmented with particulated porcine bone via a lateral window and implants were placed simultaneously .


All implants were submerged and loaded , after 4 months , with provisional prostheses .


Four months later , definitive metal-ceramic prostheses were delivered .


Outcome measures were prosthesis and implant failures , any complication and radiographic peri-implant marginal bone level changes .


One patient treated in the mandible dropped out before the 1-year post-loading follow-up .


All maxillary implants and prostheses were successful , whereas 2 mandibular prostheses could not be placed on implants at least 10 mm long due to graft failures ; one was associated with the loss of 3 implants because of infection .


There were no statistically significant differences in implant and prosthesis failures , though significantly more complications occurred at grafted sites in mandibles ( P = 0.0078 ) , but not in maxillae ( P = 0.1250 ) .


In total , 14 complications occurred in 12 patients at augmented sites versus none at 6 mm-long implants .


All failures and complications occurred before loading .


Patients with mandibular 6 mm-long implants lost an average of 1.05 mm of peri-implant bone at 1 year and patients with mandibular implants at least 10 mm long lost 1.07 mm .


These differences were statistically significant ( P < 0.001 ) .


Patients with maxillary 6 mm-long implants lost an average of 1.02 mm of peri-implant bone at 1 year and patients with maxillary implants at least 10 mm long lost 1.09 mm .


There were no statistically significant differences in bone level changes up to 1 year between 6 mm and at least 10 mm-long implants in both jaws ( mandibles n = 18 , mean difference -0.02 mm , 95 % CI -0.16 to 0.12 , P = 0.7384 ; maxillae n = 20 , mean difference -0.07 mm , 95 % CI -0.18 to 0.05 , P = 0.2547 ) .


Short-term data ( 1 year after loading ) indicate that 6 mm-long implants with a conventional diameter of 4 mm achieved similar if not better results than longer implants placed in augmented bone .


Short implants might be a preferable choice to bone augmentation , especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity .


However , data obtained 5 to 10 years after loading are necessary before making reliable recommendations .


CONFLICT OF INTEREST STATEMENT : Tecnoss and Southern Implants partially supported this trial and donated biomaterials , implants and prosthetic components used in this study .


However , the data belonged to the authors and by no means did the manufacturers interfere with the conduct of the trial or the publication of its results .


Patients often report greater visual difficulties at home than expected from vision testing in the clinic .


Such discordance may be owing to worse vision in the home than measured in clinic .


To compare vision measured between the clinic and home and evaluate factors , including lighting , associated with these differences .


This cross-sectional study conducted from 2005-2009 involved 126 patients with glaucoma and 49 without glaucoma recruited from the Glaucoma and Comprehensive Eye Clinics at Washington University , St Louis , Missouri .


Patients underwent clinic and home visits , were aged 55 to 90 years , were consecutively recruited , and met inclusion criteria for this study .


A total of 166 eligible patients refused participation .


Participants underwent clinic and home visits randomized to order of completion .


At each visit , masked and certified examiners measured binocular distance visual acuity ( DVA ) with a nonbacklit chart , near visual acuity ( NVA ) , contrast sensitivity ( CS ) , CS with glare , and lighting .


Differences in vision between the clinic and home .


The mean scores for all vision tests were significantly better in the clinic than home for participants with and without glaucoma ( P < .05 , matched-pair t tests ) .


For DVA , 29 % of participants with glaucoma read 2 or more lines better in the clinic than home and 39 % with advanced glaucoma read 3 or more lines better .


For the entire sample , 21 % of participants read 2 or more lines better in the clinic than home for NVA and 49 % read 2 or more triplets better in the clinic for CS with glare .


Lighting was the most significant factor associated with differences in vision between the clinic and home for DVA , NVA , and CS with glare testing ( P < .05 , multiple regression model ) .


Median home lighting was 4.3 times and 2.8 times lower than clinic lighting in areas tested for DVA and NVA , respectively .


Home lighting was below that recommended in 85 % or greater of participants .


Vision measured in the clinic is generally better than vision measured at home , with differences mainly owing to poor home lighting .


Knowledge that vision discrepancies between patient report and clinical testing may be owing to home lighting may initiate clinician-patient discussions to optimize home lighting and improve the vision of older adults in their homes .


Neuromuscular electrical stimulation ( NMES ) improves muscle performance and exercise tolerance in chronic obstructive pulmonary disease ( COPD ) patients .


In contrast , no study has assessed the effect of NMES on dynamic hyperinflation ( DH ) in COPD .


This study investigated the effect of short-term , high-frequency NMES on DH in patients with COPD .


Twenty patients were randomly allocated to either a NMES applied bilaterally to the quadriceps muscles ( n = 11 : 8 weeks , 5 days/week , twice/day , 45 min/session ) or a control group ( n = 09 ) .


All patients received respiratory physical therapy and stretching exercises .


Free fat mass , pulmonary function , time to exercise tolerance ( Tlim ) , 6-min walk test distance ( 6-MWTD ) , tumor necrosis factor ( TNF - ) and - endorphin levels , Borg dyspnea and leg score ( BDS and BLS ) and quality of life by the St. George 's Respiratory Questionnaire score ( SGRQ ) were examined before and after the intervention .


Compared with the control group , NMES increased FEV1 and FEV1/FVC , 6-MWD and Tlim ( P < 0.01 ) and reduced BDS and SGRQ ( P < 0.01 ) .


Additionally , changes in the Tlim were positively correlated with respiratory improvements in FEV1 ( rho = 0.48 , P < 0.01 ) .


Also , NMES reduced TNF - and increased - endorphin levels , compared with the control group ( P < 0.001 ) .


In summary , 8 weeks of NMES promotes reduction of the perceived sensation of dyspnea during exercise in patients with COPD .


This finding is accompanied by improvements in FEV1 , exercise tolerance and quality of life , and DH .


Interestingly , these findings may be associated with enhanced vasodilatory function and a reduction in inflammatory responses .


NCT01695421 .


Small pigtail catheters appear to work as well as the traditional large-bore chest tubes in patients with traumatic pneumothorax , but it is not known whether the smaller pigtail catheters are associated with less tube-site pain .


This study was conducted to compare tube-site pain following pigtail catheter or chest tube insertion in patients with uncomplicated traumatic pneumothorax .


This prospective randomized trial compared 14-Fr pigtail catheters and 28-Fr chest tubes in patients with traumatic pneumothorax presenting to a level I trauma centre from July 2010 to February 2012 .


Patients who required emergency tube placement , those who refused and those who could not respond to pain assessment were excluded .


Primary outcomes were tube-site pain , as assessed by a numerical rating scale , and total pain medication use .


Secondary outcomes included the success rate of pneumothorax resolution and insertion-related complications .


Forty patients were enrolled .


Baseline characteristics of 20 patients in the pigtail catheter group were similar to those of 20 patients in the chest tube group .


No patient had a flail chest or haemothorax .


Pain scores related to chest wall trauma were similar in the two groups .


Patients with a pigtail catheter had significantly lower mean ( s.d. ) tube-site pain scores than those with a chest tube , at baseline after tube insertion ( 3.2 ( 0.6 ) versus 7.7 ( 0.6 ) ; P < 0.001 ) , on day 1 ( 1.9 ( 0.5 ) versus 6.2 ( 0.7 ) ; P < 0.001 ) and day 2 ( 2.1 ( 1.1 ) versus 5.5 ( 1.0 ) ; P = 0.040 ) .


The decreased use of pain medication associated with pigtail catheter was not significantly different .


The duration of tube insertion , success rate and insertion-related complications were all similar in the two groups .


For patients with a simple , uncomplicated traumatic pneumothorax , use of a 14-Fr pigtail catheter is associated with reduced pain at the site of insertion , with no other clinically important differences noted compared with chest tubes .


NCT01537289 ( http://clinicaltrials.gov ) .


The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial .


Random allocation of 24 edentulous participants ( age range : 45 to 86 years ) into titanium ( control ) or zirconia ( test ) groups using onepiece implants and a planned unsplinted prosthodontic design was performed .


Four maxillary implants ( one midpalatal ; three anterior crestal ) and three mandibular implants ( one midsymphyseal ; two bilateral distal ) were conventionally loaded with the overdentures .


Similar attachment systems were used throughout : ball abutment-type patrices ( diameter : 2.25 to 3.1 mm as part of the one-piece implants ) and custommade plastic matrices ( with or without metal housings depending on the patrix size ) .


Prosthodontic outcomes were documented during the first year of the clinical trial .


Following three deaths and two dropouts , there were 19 participants who were available at the 1-year recall .


Of these participants , 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures .


There were 79 maintenance events , 34 in the titanium ( control ) group and 45 in the zirconia ( test ) group .


Patrix loss occurred as a result of three zirconia implant fractures ( one mandibular and two crestal maxillary implants ) .


Maintenance events were principally the replacement of matrices and overdenture fracture .


Although relines and replacement overdentures also occurred , overall there were no significant differences in prosthodontic maintenance between the control and test groups .


A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups ; however , 50 % of participants in each group were allocated to the retreatment ( repair ) field , which produced a low prosthodontic success rate .


Removable overdentures can be used on both one-piece titanium and zirconia implants with these attachment systems , due to no difference in prosthodontic maintenance and success .


Before recommending routine use of a `` metal-free '' overdenture treatment option in clinical practice , consideration must be given to the success of the implants themselves .


Insulin regulates the secretion of insulin-like growth factor I ( IGF-I ) in the newborn , and low levels of IGF-I have been linked to neonatal morbidity .


As part of the Neonatal Insulin Replacement Therapy in Europe Trial , we investigated the impact of early insulin treatment on IGF-I levels and their relationship with morbidity and growth .


Prospective cohort analyses of data collected as part of an international randomized controlled trial .


Blood samples ( days 1 , 3 , 7 , and 28 ) , were taken for IGF-I bioassay from 283 very low birth weight infants ( < 1500 g ) .


Early insulin treatment led to a late increase in IGF-I levels between day 7 and 28 ( P = .028 ) .


In the first week of life IGF-I levels were lower in infants with early hyperglycemia ; mean difference -0.10 g/L ( 95 % CI -0.19 , -0.02 , P = .02 ) .


Lower levels of IGF-I at day 28 were independently associated with an increased risk of chronic lung disease , OR 3.23 ( 95 % CI , 1.09-9 .10 ) , and greater IGF-I levels were independently associated with better weight gain , 0.10 kg ( 95 % CI , 0.03-0 .33 , P = .02 ) .


Early intervention with insulin is related to increased IGF-I levels at 28 days .


Low IGF-I levels are associated with hyperglycemia , increased morbidity , and reduced growth .


Increasing IGF-I levels may improve outcomes of very low birth weight infants .


To determine whether provision of vaccine-health-literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for children in need of 2 doses .


During the 2012-2013 season , families of eligible 6-month through 8-year-old children were recruited at the time of their first influenza vaccination from 3 community clinics in New York City .


Children ( n = 660 ) were randomly assigned to `` educational '' text message , `` conventional '' text message , and `` written reminder-only '' arms .


At enrollment , all arms received a written reminder with next dose due date .


Conventional messages included second dose due date and clinic walk-in hours .


Educational messages added information regarding the need for a timely second dose .


Receipt of second dose by April 30 was assessed by using ( 2 ) tests .


Timeliness was assessed by receipt of second dose by 2 weeks after due date ( day 42 ) using ( 2 ) and over time using a Kaplan-Meier analysis .


Most families were Latino and publicly insured with no significant between-arm differences between groups .


Children in the educational arm were more likely to receive a second dose by April 30 ( 72.7 % ) versus conventional ( 66.7 % ) versus written reminder-only arm ( 57.1 % ; P = .003 ) .


They also had more timely receipt by day 42 ( P < .001 ) and over time ( P < .001 ) .


In this low-income , urban , minority population , embedding health literacy information improved the effectiveness of text message reminders in promoting timely delivery of a second dose of influenza vaccine , compared with conventional text messages and written reminder only .


The purpose of this single-blinded , randomized controlled study was to examine and compare the immediate and retention effects of progressive speed-dependent treadmill training ( SDTT ) and rhythmic auditory-cued ( RAC ) training on balance function , fall incidence , and quality of life ( QOL ) in individuals with PD .


Twenty participants ( mean age 66.1 yrs ) with idiopathic PD were randomized into either SDTT ( n = 10 ) or RAC ( n = 10 ) progressive , interval-based locomotor training for 6 weeks .


Measures included the Berg Balance Scale ( BBS ) , Rapid Step-Up Test ( RST ) , Activities-specific Balance Confidence Scale , Parkinson 's Disease Questionnaire-39 ( PDQ ) , and the NeuroCom Sensory Organization Test ( SOT ) , Motor Control Test , and Limits of Stability ( LOS ) .


Fall incidence was assessed prospectively post-training based on six monthly self-report fall calendars .


Significant gains in balance measures were observed post-training in BBS , RST and SOT for the RAC group and in RST , SOT and LOS for the SDTT group .


Gains were retained at 3 months post-training in all measures for RAC group , but only the RST for the SDTT group .


No clear trend in reduction in fall frequency was evident .


Externally-cued locomotor training paradigms with progressive speed challenges produced significant improvements in dynamic balance function in persons with PD , with stronger retention of gains in RAC group .


To compare the effectiveness of the endolymphatic duct blockage ( EDB ) and the endolymphatic sac decompression ( ESD ) to control Mnire 's disease symptoms and to evaluate their effect on hearing level .


Prospective nonblinded randomized study .


Tertiary medical center .


Fifty-seven patients affected by a refractory Mnire 's disease were included out of which 22 underwent an ESD and 35 underwent an EDB .


Five periods of follow-up were considered : 0 to 1 week , 1 week to 6 months , 6 to 12 months , 12 to 18 months , and 18 to 24 months .


Mean outcome measurements consisted of vertigo control , tinnitus , aural fullness , instability , and hearing level .


Hearing level was evaluated using pure-tone average ( PTA ) and speech discrimination score ( SDS ) .


There was no significant difference between the 2 groups in the number of vertigo spells per months preoperatively ( P = .153 ) .


Twenty-four months postoperatively , 96.5 % of the EDB group had achieved a complete control of vertigo spells against 37.5 % of the ESD group with a statistically significant difference ( P = .002 ) .


There was a better control of tinnitus and aural fullness with EDB ( P = .021 and P = .014 , respectively ) .


There was no statistically significant difference in hearing level preoperatively ( P = .976 ) and 24 months postoperatively ( P = .287 ) between the 2 groups .


Hearing level was preserved in each group with no significant difference between the preoperative and the postoperative levels ( P > .05 ) .


EDB is more effective than the traditional ESD in controlling the symptoms of Mnire 's disease .


It is a novel surgical technique with promising results for a complete treatment of Mnire 's disease .


There are no significant complications or adverse effect .


Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy ( RT ) .


A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume ( BV ) and thus reduce the bladder-related organ motion .


The secondary endpoints were to assess the incidence of acute and late genitourinary ( GU ) and gastrointestinal ( GI ) toxicity for patients and patients ' satisfaction with the bladder-filling instructions .


One hundred ten patients were randomly assigned to 1 of 2 bladder-filling protocols ; 540 mL ( 3 cups ) of water or 1080 mL ( 6 cups ) of water , in a single institution trial .


A portable ultrasound device , BladderScan BVI 6400 ( Verathon Inc , Bothell , WA ) , measured BVs at treatment planning computed tomography ( TPCT ) scan and 3 times per week during RT. .


Maximum bladder dose and BV receiving 50 , 60 , and 70 Gy were recorded .


Acute and late GU and GI toxicity were evaluated , as were patients ' comfort , perception of urinary symptoms , and quality of life ( QoL ) .


There was significantly less BV variation in the 540 mL arm when compared with 1080 mL ( median : 76 mL vs 105 mL , P = .003 ) .


Larger BVs on initial TPCT correlated with larger BV variations during RT ( P < .0005 ) .


There were no statistically significant associations between arm and GU/GI toxicity , dose median comfort scores , or median QoL scores .


The 540 mL bladder-filling arm resulted in reproducible BVs throughout a course of RT , without any deterioration in QoL or increase in toxicities for prostate patients .


Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries .


Safe , effective , and affordable rotavirus vaccines are needed in these countries .


We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India .


We did a randomised double-blind , placebo-controlled , multicentre trial at three sites in Delhi ( urban ) , Pune ( rural ) , and Vellore ( urban and rural ) between March 11 , 2011 , and Nov 5 , 2012 .


Infants aged 6-7 weeks were randomly assigned ( 2:1 ) , via a central interactive voice or web response system with a block size of 12 , to receive either three doses of oral human-bovine natural reassortant vaccine ( 116E ) or placebo at ages 6-7 weeks , 10 weeks , and 14 weeks .


Infants ' families , study investigators , paediatricians in referral hospitals , laboratory staff , and committee members were all masked to treatment allocation .


The primary outcome was incidence of severe rotavirus gastroenteritis ( 11 on the Vesikari scale ) .


Efficacy outcomes and adverse events were ascertained through active surveillance .


Analysis was by intention to treat and per protocol .


The trial is registered with Clinical Trial Registry-India ( CTRI/2010/091 / 000102 ) and ClinicalTrials.gov ( NCT01305109 ) .


4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo , of whom 4354 ( 96 % ) and 2187 ( 96 % ) infants , respectively , were included in the primary per-protocol efficacy analysis .


71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group ; vaccine efficacy against severe rotavirus gastroenteritis was 536 % ( 95 % CI 350-669 ; p = 00013 ) and 564 % ( 366-701 ; p < 00001 ) in the first year of life .


The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 ( 95 % CI 37-97 ) .


The incidence of severe rotavirus gastroenteritis per 100 person-years was 15 in the vaccine group and 32 in the placebo group , with an incidence rate ratio of 046 ( 95 % CI 033-065 ) .


Prevalence of immediate , solicited , and serious adverse events was similar in both groups .


One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product .


We recorded six cases of intussusception in the vaccine group and two in the placebo group , all of which happened after the third dose .


25 ( < 1 % ) infants in the vaccine group and 17 ( < 1 % ) in the placebo group died ; no death was regarded as related to the study product .


Monovalent human-bovine ( 116E ) rotavirus vaccine is effective and well tolerated in Indian infants .