From baseline to week 4 , both curcumin and placebo were associated with improvements in IDS-SR30 total score and most secondary outcome measures .


From weeks 4 to 8 , curcumin was significantly more effective than placebo in improving several mood-related symptoms , demonstrated by a significant group x time interaction for IDS-SR30 total score ( F1 , 53 = 4.22 , p = .045 ) and IDS-SR30 mood score ( F1 , 53 = 6.51 , p = .014 ) , and a non-significant trend for STAI trait score ( F1 , 48 = 2.86 , p = .097 ) .


Greater efficacy from curcumin treatment was identified in a subgroup of individuals with atypical depression .


Partial support is provided for the antidepressant effects of curcumin in people with major depressive disorder , evidenced by benefits occurring 4 to 8 weeks after treatment .


Investigations with larger sample sizes , over extended treatment periods , and with varying curcumin dosages are required .


Malaria continues to be a prominent global public health challenge .


This study tested the effectiveness of two service delivery models for reducing the malaria burden , e.g. supportive supervision of community health workers ( CHW ) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha , India .


The study population comprised 120 villages from two purposively chosen malaria-endemic districts , with 40 villages randomly assigned to each of the two treatment arms , one with both supportive supervision and community mobilization and one with community mobilization alone , as well as an observational control arm .


Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group .


Analysis was by intention-to-treat .


Significant improvements were observed in the reported utilization of bed nets in both intervention arms ( 84.5 % in arm A and 82.4 % in arm B versus 78.6 % in the control arm ; p < 0.001 ) .


While overall rates of treatment-seeking were equal across study arms , treatment-seeking from a CHW was higher in both intervention arms ( 28 % ; p = 0.005 and 27.6 % ; p = 0.007 ) than in the control arm ( 19.2 % ) .


Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm ( 82.1 % vs. 67.1 % ; p = 0.025 ) .


Care-seeking from trained providers also increased with a substitution away from untrained providers .


Further , fever cases from the combined interventions arm ( 60.6 % ; p = 0.004 ) and the community mobilization arm ( 59.3 % ; p = 0.012 ) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm ( 50.1 % ) .


In particular , women from the combined interventions arm were more likely to have received timely treatment from a skilled provider ( 61.6 % vs. 47.2 % ; p = 0.028 ) .


A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme .


To compare immediate and 12h postoperative removal of urinary catheter after elective cesarean section .


In a prospective clinical trial at a university teaching hospital , 300 eligible women admitted for primary or repeat elective cesarean section were randomized into two equal groups .


In group A , the catheter was removed immediately after the procedure ; whereas in group B , the catheter was removed 12h postoperatively .


The incidence of postoperative significant bacteruria ( p = 0.020 ) , dysuria ( p = 0.030 ) , burning on micturition ( p = 0.016 ) , urinary frequency ( p = 0.031 ) , and urgency ( p = 0.011 ) were significantly lower in group A compared with group B.


The mean postoperative ambulation time ( p < 0.001 ) , time till the first voiding ( p < 0.001 ) , and length of hospital stay ( p < 0.001 ) were also significantly shorter in group A.


There were no significant differences between the two groups in the incidence of urinary retention necessitating recatheterization ( p = 0.371 ) .


Immediate removal of urinary catheter after elective cesarean section is associated with lower risk of urinary infection and earlier postoperative ambulation .


Scoliosis repair is a major orthopaedic surgery associated with severe post-operative pain .


Ketamine and magnesium have an established efficacy as morphine-sparing agents .


Our purpose was to evaluate the morphine-sparing effect of both magnesium and ketamine given simultaneously compared with ketamine alone during scoliosis surgery .


Fifty patients scheduled for posterior instrumentation were randomised in a prospective double-blind study .


The Gr ( K + Mg ) received , after induction , an intravenous ( IV ) bolus of ketamine 0.2 mg/kg and magnesium 50 mg/kg , followed by continuous infusion of ketamine ( 0.15 mg/kg/h ) and magnesium ( 8 mg/kg/h ) until extubation .


The Gr ( K ) received the same dose of ketamine associated with bolus and continuous infusion of normal saline .


All patients received multimodal analgesia associated with IV morphine administered via patient-controlled analgesia pump .


Morphine consumption , visual analogue scale ( VAS ) pain scores and occurrence of side effects were followed until 48 h post-operatively .


Sleep quality and patient satisfaction were also followed .


P < 0.05 was considered statistically significant .


The average cumulative morphine consumption was significantly lower in the Gr ( K + Mg ) compared with the Gr ( K ) at post-operative hours 4 , 8 , 12 , 18 , 30 , 36 and 48 .


The relative difference in the post-operative morphine consumption was 29.5 % : Gr ( K + Mg ) 51.53 mg vs. Gr ( K ) 73.16 mg .


VAS scores were not statistically different between the two groups .


However , qualities of sleep and satisfaction scores on the first night were significantly better in the Gr ( K + Mg ) ( P = 0.027 and P = 0.016 , respectively ) .


Ketamine and magnesium association reduces the post-operative morphine consumption after scoliosis surgery .


It seems to provide a better sleep quality and improves patient satisfaction .


Prolonged sitting time has been identified as a health risk factor .


Sit-stand workstations allow desk workers to alternate between sitting and standing throughout the working day , but not much is known about their acceptability and feasibility .


Hence , the aim of this study was to qualitatively evaluate the acceptability , feasibility and perceptions of using sit-stand workstations in a group of desk-based office workers .


This article describes the qualitative evaluation of the randomized controlled cross-over Stand@Work pilot trial .


Participants were adult employees recruited from a non-government health agency in Sydney , Australia .


The intervention involved using an Ergotron Workfit S sit-stand workstation for four weeks .


After the four week intervention , participants shared their perceptions and experiences of using the sit-stand workstation in focus group interviews with 4-5 participants .


Topics covered in the focus groups included patterns of workstation use , barriers and facilitators to standing while working , effects on work performance , physical impacts , and feasibility in the office .


Focus group field notes and transcripts were analysed in an iterative process during and after the data collection period to identify the main concepts and themes .


During nine 45-min focus groups , a total of 42 participants were interviewed .


Participants were largely intrinsically motivated to try the sit-stand workstation , mostly because of curiosity to try something new , interest in potential health benefits , and the relevance to the participant 's own and organisation 's work .


Most participants used the sit-stand workstation and three common usage patterns were identified : task-based routine , time-based routine , and no particular routine .


Common barriers to sit-stand workstation use were working in an open plan office , and issues with sit-stand workstation design .


Common facilitators of sit-stand workstation use were a supportive work environment conducive to standing , perceived physical health benefits , and perceived work benefits .


When prompted , most participants indicated they were interested in using a sit-stand workstation in the future .


The use of a sit-stand workstation in this group of desk-based office workers was generally perceived as acceptable and feasible .


Future studies are needed to explore this in different desk-based work populations and settings .


The aim was to investigate whether a strategy of direct drug-eluting stent ( DES ) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting ( PS ) .


Previous studies were performed comparing direct stenting ( DS ) with conventional stenting ( CS ) after pre-dilation ; however , none of these in the DES era .


Therefore , the STRESSED ( direct Stenting To reduce REStenosis in Stent Era with Drug elution ) study was designed and carried out .


A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS , CS , or PS strategy .


The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography .


Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events ( MACE ) , and MACE at 9-month and 2-year follow-up .


Stent implantation in the DS group was 98 % , 99 % in the CS group , and 77 % in the PS group .


Percutaneous coronary intervention success was 99 % in all groups .


The minimal lumen diameter at 9-month follow-up was 2.12 0.58 mm ( DS ) , 2.17 0.67 mm ( CS ) , and 1.99 0.69 mm ( PS ) , p = 0.556 for comparison of DS with CS , p = 0.073 for comparison of DS with PS .


The absolute difference was-0 .05 ( DS to CS ) , 95 % confidence interval : -0.19 to-0 .09 , p = 0.48 and 0.13 ( DS to PS ) , confidence interval : -0.02 to-0 .27 , p = 0.087 .


Restenosis was found in 3.4 % ( DS ) , 6.7 % ( CS ) , and 11.5 % ( PS ) , p = 0.025 .


At 9-month and 2-year follow-up , MACE occurred in 6.8 % and 11.5 % ( DS ) , 4.6 % and 10.3 % ( CS ) , and 7.6 % and 13.8 % ( PS ) ( p = 0.439 and 0.536 ) , respectively .


Direct DES implantation compared with conventional DES implantation did not reduce restenosis .


Provisional stenting , however , was associated with a higher rate of restenosis .


This did not translate into a difference in the rate of MACE .


( STRESSED study : direct Stenting To reduce REStenosis in Stent Era with Drug elution ; ISRCTN41213536 ) .


The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections , including Trichomonas vaginalis ( TV ) .


Data were analyzed from HIV-1-seronegative women participating in HIV Prevention Trials Network Protocol 035 .


At quarterly visits for up to 30 months , participants completed structured interviews and specimens were collected for genital tract infection testing .


T. vaginalis was detected by saline microscopy .


Bacterial vaginosis ( BV ) was characterized by Gram stain using the Nugent score ( BV = 7-10 ; intermediate = 4-6 ; normal = 0-3 [ reference group ] ) .


Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition .


In this secondary analysis , 2920 participants from Malawi , South Africa , United States , Zambia , and Zimbabwe contributed 16,259 follow-up visits .


Bacterial vaginosis was detected at 5680 ( 35 % ) visits , and TV was detected at 400 ( 2.5 % ) visits .


Adjusting for age , marital status , hormonal contraceptive use , unprotected sex in the last week and TV at baseline , intermediate Nugent score , and BV at the prior visit were associated with an increased risk of TV ( intermediate score : adjusted hazard ratio [ aHR ] , 1.73 ; 95 % confidence interval [ CI ] , 1.21-2 .19 ; BV : aHR , 2.40 ; 95 % CI , 1.92-3 .00 ) .


Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population ( intermediate score : aHR , 1.54 ; 95 % CI , 1.10-2 .14 ; BV : aHR , 2.23 ; 95 % CI , 1.75-2 .84 ) .


Women with a Nugent score higher than 3 were at an increased risk for acquiring TV .


If this relationship is causal , interventions that improve the vaginal microbiota could contribute to reductions in TV incidence .


Habitual exposure to carbon dioxide ( CO2 ) is expected , but it is not proven , to dull ventilatory sensitivity to co2 by reducing hypercapnic ventilatory response ( HCVR ) as it is expressed by the slope of the derived response curve ( CO2 sensitivity : VE/PetCO2 ) .


It was hypothesized that HCVR is decreased by repeated breath hold maximal efforts ( RBHE ) before and after apnea training in comparison with no training and the control condition .


Two groups of breath holders , a control ( CBH ) group and novices to breath hold activities ( NBH ) , visited the laboratory on four different occasions .


In the first visit , subjects performed a HCVR test , whereas in the second visit they completed five successive RBHE separated by 2-min intervals .


Another HCVR test was performed 2 min after cessation of the last apnea .


For the next 14 d , only the NBH group trained by performing daily five RBHE separated by 2-min intervals .


Subsequently , in a third and a fourth condition , subjects repeated the experimental protocol of the second and first visit .


Although breath hold time ( BHT ) increased after apnea training in the NBH group by ~ 46 % , CO2 sensitivity slopes were not different among experimental conditions and groups ( 2.8 0.3 , 2.9 0.4 L min ( 1 ) mmHg ( 1 ) in the CBH and 2.7 0.5 , 2.7 0.3 L min ( 1 ) mmHg ( 1 ) in the NBH during the second and third visit , respectively ) .


HCVR after five RBHE or 14 d of apnea training was not decreased despite the achieved BHT enhancement .


Hypercapnic dullness of ventilation is a complex biological process which takes more than 14 d of training to develop .


Bourdas DI , Tsakiris TS , Pavlakis KI , Triantafillou DV , Geladas ND .


Repeated apneas and hypercapnic ventilatory response before and after apnea training .


Olive oil-based lipid emulsion ( LE ) and medium chain triglyceride/long chain triglyceride ( MCT/LCT ) emulsion are both LEs with low -6 polyunsaturated fat acids ( PUFAs ) content .


However , which one of these LEs is associated with a lower infection risk in patients receiving parenteral nutrition ( PN ) remains unclear .


The aim of the study was to compare the effects of the two LEs in PN in esophageal cancer patients undergoing surgery .


Patients with resectable esophageal carcinoma were recruited and allocated randomly to two groups .


The test group was given enteral nutrition ( EN ) with PN containing olive oil-based LE after tumor resection for 7 days , and the patients in the control group were supported by EN with MCT/LCT emulsion-based PN after surgery for the same time period .


Immunological markers and inflammatory indicators were tested and perioperative clinical outcomes were determined .


The trial was registered in the Chinese Clinical Trial Register , number ChiCTR-TRC-13003562 .94 Patients were recruited , and grouped ( olive oil-based LE , n = 46 and MCT/LCT , n = 48 ) , matched for sex , age , body mass index , histological type , TNM stage , and nutrition risk screening ( NRS ) 2002 score .


There were no differences in perioperative fever ( > 38 C ) , infectious complications , length of hospital stay ( > 14 days ) , length of critical care stay ( > 2 days ) , time for oral food intake , and in-hospital mortality between the two groups .


The test group showed a higher increase in IgG level compared with the MCT/LCT group ( p = 0.028 ) .


There was no difference in other immunological markers and inflammatory indicators between the two groups .


PN containing olive oil-based or MCT/LCT LEs had similar effects on perioperative outcome , cell-mediated immune function and inflammatory response in esophageal cancer patients who had undergone surgery and were receiving EN .


Cardiac surgery is accompanied by an increase of oxidative stress , a significantly reduced antioxidant ( AOX ) capacity , postoperative inflammation , all of which may promote the development of organ dysfunction and an increase in mortality .


Selenium is an essential co-factor of various antioxidant enzymes .


We hypothesized a less pronounced decrease of circulating selenium levels in patients undergoing off-pump coronary artery bypass ( OPCAB ) surgery due to less intraoperative oxidative stress .


In this prospective randomised , interventional trial , 40 patients scheduled for elective coronary artery bypass grafting were randomly assigned to undergo either on-pump or OPCAB-surgery , if both techniques were feasible for the single patient .


Clinical data , myocardial damage assessed by myocard specific creatine kinase isoenzyme ( CK-MB ) , circulating whole blood levels of selenium , oxidative stress assessed by asymmetric dimethylarginine ( ADMA ) levels , antioxidant capacity determined by glutathionperoxidase ( GPx ) levels and perioperative inflammation represented by interleukin-6 ( IL-6 ) levels were measured at predefined perioperative time points .


At end of surgery , both groups showed a comparable decrease of circulating selenium concentrations .


Likewise , levels of oxidative stress and IL-6 were comparable in both groups .


Selenium levels correlated with antioxidant capacity ( GPx : r = 0.720 ; p < 0.001 ) and showed a negative correlation to myocardial damage ( CK-MB : r = -0.571 , p < 0.001 ) .


Low postoperative selenium levels had a high predictive value for the occurrence of any postoperative complication .


OPCAB surgery is not associated with less oxidative stress and a better preservation of the circulating selenium pool than on-pump surgery .


Low postoperative selenium levels are predictive for the development of complications .


ClinicalTrials.gov NCT01409057 .


Post-operative nausea and vomiting is one of the most frequently occurring side effects affecting one third of the cases .


Objective of the study was to compare the efficacy of ondansetron alone and ondansetron plus dexamethasone in preventing postoperative nausea and vomiting after middle ear surgery .


This randomized controlled trial was conducted at the Anaesthesia and ENT departments of Ayub Medical College , Abbottabad from January-June 2012 .


Forty American Society of Anaesthesiologists ( ASA ) I and 2 physical status patients undergoing middle ear surgery were divided into two groups by blocked randomization .


Patients in group-1 ( n = 20 ) received ondansetron 4 mg while group-II ( n = 20 ) received ondansetron 4 mg with dexamethasone 8 mg just before start of operation .


The whole postoperative period of 24 hours was divided into two phases , early 0-6 hours and late phase 6-24 hour .


Nausea score and its frequency was significantly higher in Group-I ( p < 0.05 ) .


Vomiting and its frequency were found more in group-I patients .


In Group-II , the nausea score was significantly less ( p < 0.01 ) at 6 and 24 hours after surgery .


The total incidence of vomiting was reduced from 28 % in group-1 to 6 % in group-II .


Rescue antiemetic requirement was significantly less ( p < 0.01 ) in group-II .


Prophylaxis with a combination of ondansetron and dexamethasone decreased the incidence of nausea and vomiting after middle ear surgery .


Ulcerative colitis ( UC ) is a chronic , relapsing and remitting intestinal inflammatory disorder .


Zinc is known to be efficacious for the repair of damaged tissue and has been shown to protect against gastric ulceration .


This study focused on Polaprezinc ( PZ ) , N - ( 3-aminopropionyl ) - L-histidinato zinc , which accelerates ulcer healing through actions such as prostaglandin-independent cytoprotection and antioxidative activity .


In this randomized , placebo-controlled , investigator-blinded trial , 28 patients with active UC at The Jikei University Hospital were randomly divided into two groups : one treated with a 150 mg PZ enema ( n = 18 ) and the other not treated with a PZ enema ( n = 10 ) .


All patients received usual induction therapy .


Clinical symptoms , endoscopic findings and histological findings were evaluated at entry and one week later .


In the PZ group , modified Matts ' endoscopic scores were significantly improved after treatment compared to baseline in the rectum ( p = 0.004 ) , sigmoid colon ( p = 0.03 ) and descending colon ( p = 0.04 ) .


In the non-PZ group , scores were not significantly improved in the rectum ( p = 0.14 ) and descending colon ( p = 0.34 ) , but were improved in the sigmoid colon ( p = 0.04 ) .


In the PZ group , the Mayo scores at baseline and at Day 8 were 9.1 1.6 and 5.8 2.7 ( p = 0.00004 ) , respectively , and in the placebo group , the scores were 8.9 1.7 and 7.4 2.1 ( p = 0.009 ) , respectively .


Clinical response or remission was significantly better in the PZ group ( 71 % ) than in the placebo group ( 10 % ) .


A zinc-carnosine chelate compound , PZ , enema may become a useful new add-on treatment to accelerate mucosal healing in UC .


Quantification of disease severity supports the development of evidence-based treatments .


Assessments to capture clinical improvement in hidradenitis suppurativa ( HS ) can be improved .


This study aimed to validate the Hidradenitis Suppurativa Clinical Response ( HiSCR ) , which is defined as a 50 % reduction in inflammatory lesion count ( sum of abscesses and inflammatory nodules , AN ) , and no increase in abscesses or draining fistulas in HS when compared with baseline as a meaningful clinical endpoint for HS treatment .


Patients with 3 ANs at baseline in a Phase II adalimumab trial for HS were included for analysis .


HiSCR achievers vs. nonachievers were assessed at week 16 and week 52 .


Criteria measures included physician-rated assessments [ Hurley stage , modified Sartorius score ( MSS ) , and HS Physician 's Global Assessment ] and patient-reported outcomes ( PROs : visual analogue pain scale , Dermatology Life Quality Index , and Work Productivity and Activity Impairment questionnaire ) .


Test-retest reliability , convergent validity , responsiveness and predictive validity of HiSCR , and its meaningfulness to patients were assessed .


Among 138 eligible study participants , the majority were female ( 696 % ) with a mean age of 367 years .


The mean ( median ) MSS was 1252 ( 855 ) at baseline .


Test-retest reliability of the AN count was 091 .


HiSCR was significantly correlated with improvements in all physician-rated and PRO measures ( Spearman 's rho between -061 and -027 , all P < 0001 ) .


Improvements of all PROs in HiSCR achievers exceeded the respective meaningful improvement thresholds .


In patients with HS with 3 ANs , HiSCR achievers had significant improvements in physician-rated and patient-reported HS disease severity and impact .


HiSCR is a valid and meaningful endpoint for assessing HS treatment effectiveness in controlling inflammatory manifestations in this population .


To assess the efficacy of yoga for motor function , mental health , and quality of life outcomes in persons with chronic poststroke hemiparesis .


Twenty-two individuals participated in a randomized controlled trial involving assessment of task-orientated function , balance , mobility , depression , anxiety , and quality of life domains before and after either a 10-week yoga intervention ( n = 11 ) or no treatment ( n = 11 ) .


The yoga intervention did not result in any significant improvements in objective motor function measures , however there was a significant improvement in quality of life associated with perceived motor function ( P = .0001 ) and improvements in perceived recovery approached significance ( P = .072 ) .


Memory-related quality of life scores significantly improved after yoga intervention ( P = .022 ) , and those participating in the intervention exhibited clinically relevant decreases in state and trait anxiety .


Preliminary results offer promise for yoga as an intervention to address mental health and quality of life in persons with stroke-related activity limitations .


There is a need to more rigorously evaluate these yoga benefits with a larger randomized controlled trial , which , based on this preliminary trial , is feasible .


Ischemic mitral regurgitation ( IMR ) results from mitral leaflet tethering from left ventricular remodeling .


Heterogeneity in local or global left ventricular remodeling can result in differential tethering patterns and affect mitral valve function and the degree of mitral regurgitation .


The aims of this study were to compare mitral valve geometry in asymmetric and symmetric tethering patterns using three-dimensional transesophageal echocardiography and to examine the impact of tethering pattern on IMR severity .


Sixty-two patients with moderate or greater IMR underwent three-dimensional transesophageal echocardiography for the assessment of mitral valve geometry .


Symmetric and asymmetric tethering patterns were determined by mitral regurgitation jet direction and coaptation of the mitral leaflets .


The ratio of posterior to anterior leaflet tethering angle was a measure of tethering pattern ( the higher the ratio , the more asymmetric the pattern ) .


Overall tethering degree was assessed by tenting volume ( TV ) .


Compared with the symmetric group , the asymmetric group had less annular dilatation , greater annular heights ( 10.3 1.9 vs 8.5 1.9 mm , P < .01 ) , greater ratios of posterior to anterior leaflet tethering angle ( 3.19 0.88 vs 1.95 0.46 , P < .01 ) , and smaller TVs with more posterior displacement of the coaptation line .


Vena contracta normalized to TV was greater in the asymmetric group ( 0.38 0.24 vs 0.19 0.13 cm/mL , P < .01 ) .


Multivariate analysis showed that both ratio of posterior to anterior leaflet tethering angle ( = 0.46 , P < .001 ) and TV ( = 0.41 , P = .001 ) were predictors of IMR severity .


Differences in mitral valve geometry are observed between asymmetric and symmetric tethering patterns in IMR .


IMR degree is affected by both the pattern of tethering and the total degree of tethering .


For the same degree of tethering , an asymmetric pattern is associated with increased MR severity .


The pattern of mitral leaflet tethering may be considered in therapeutic decision making .


Delirium is associated with substantial morbidity and mortality rates in elderly hospitalised patients , and a growing problem due to increase in life expectancy .


Implementation of standardised non-pharmacological delirium prevention strategies is challenging and adherence remains low .


Pharmacological delirium prevention with haloperidol , currently the drug of choice for delirium , seems promising .


However , the generalisability of randomised controlled trial results is questionable since studies have only been performed in selected postoperative hip-surgery and intensive care unit patient populations .


We therefore present the design of the multicenter , randomised , double-blind , placebo-controlled clinical trial on early pharmacological intervention to prevent delirium : haloperidol prophylaxis in older emergency department patients ( The HARPOON study ) .


In six Dutch hospitals , at-risk patients aged 70 years or older acutely admitted through the emergency department for general medicine and surgical specialties are randomised ( n = 390 ) for treatment with prophylactic haloperidol 1 mg or placebo twice daily for a maximum of seven consecutive days .


Primary outcome measure is the incidence of in-hospital delirium within seven days of start of the study intervention , diagnosed with the Confusion Assessment Method , and the Diagnostic and Statistical Manual of Mental Disorders , fourth edition criteria for delirium .


Secondary outcome measures include delirium severity and duration assessed with the Delirium Rating Scale Revised 98 ; number of delirium-free days ; adverse events ; hospital length-of-stay ; all-cause mortality ; new institutionalisation ; ( Instrumental ) Activities of Daily Living assessed with the Katz Index of ADL , and Lawton IADL scale ; cognitive function assessed with the Six-item Cognitive Impairment Test , and the Dutch short form Informant Questionnaire on Cognitive Decline in the Elderly .


Patients will be contacted by telephone three and six months post-discharge to collect data on cognitive - and physical function , home residency , all-cause hospital admissions , and all-cause mortality .


The HARPOON study will provide relevant information on the efficacy and safety of prophylactic haloperidol treatment for in-hospital delirium and its effects on relevant clinical outcomes in elderly at-risk medical and surgical patients .


EudraCT Number : 201100476215 ; ClinicalTrials.gov Identifier : NCT01530308 ; Dutch Clinical Trial Registry : NTR3207 .


This study was designed to compare the performances of 4 airway devices in achieving successful ventilation .


A randomized crossover trial was conducted to evaluate 4 airway devices : laryngeal mask airway ( LMA ) , i-gel ( iGEL ) , PENTAX Airway Scope ( AWS ) , and Macintosh laryngoscope ( MCL ) .


Thirty-eight unskilled rescuers performed intubation on a manikin during chest compressions in normal and difficult airway scenarios .


The time to ventilation , intubation success rate , and difficulty of intubation were measured .


The time to ventilation of the airway devices in the normal scenario had a median value of 8.8 seconds ( interquartile range , 7.3-10 .5 seconds ) for iGEL , 16.1 seconds ( 13.9-19 .3 seconds ) for LMA , 30.6 seconds ( 24.6-37 .6 seconds ) for AWS , and 35.0 seconds ( 29.5-45 .9 seconds ) for MCL .


In the difficult airway scenario , the respective time to ventilation was 8.6 seconds ( 7.8-10 .0 seconds ) , 15.3 seconds ( 14.3-20 .2 seconds ) , 29.4 seconds ( 25.7-36 .3 seconds ) and 59.0 seconds ( 46.1-103 .3 seconds ) .


The success rates were 100 % and 100 % for LMA , 100 % and 100 % for iGEL , 97.4 % and 94.7 % for AWS , and 78.9 % and 47.4 % for MCL in the normal and difficult airway scenarios .


The difficulties of intubation expressed as numerical rating scale were 2.0 and 2.0 ( median values ) for LMA , 1.0 and 2.0 for iGEL , 3.0 and 3.0 for AWS , and 4.0 and 5.0 for MCL in the normal and difficult airway scenarios , respectively .


With novice intubators who were unfamiliar with the airway devices , the LMA , iGEL , and AWS were superior to the MCL for establishing an airway without interruption of chest compressions in a manikin study .


Intubation with the iGEL was faster and easier than with the other airway devices .


Myeloablative allogeneic haematopoietic stem cell transplantation ( allo-HSCT ) is a major procedure usually accompanied by multifactorial malnutrition , prompting the recommendation of systematic artificial nutritional support .


Parenteral nutrition ( PN ) is usually administered during allo-HSCT , essentially for practical reasons .


Recently published data suggest that enteral nutrition ( EN ) , given as systematic artificial nutrition support , could decrease grade III-IV graft-versus-host disease ( GVHD ) and infectious events , which are associated with early toxicity after allo-HSCT and then have an impact on early transplant-related mortality ( D100 mortality ) .


We report on the NEPHA trial : an open-label , prospective , randomised , multi-centre study on two parallel groups , which has been designed to evaluate the effect of EN compared to PN on early toxicity after an allo-HSCT procedure .


Two hundred forty patients treated with allo-HSCT for a haematological malignancy will be randomly assigned to two groups to receive either EN or PN .


The primary endpoint will assess the effect of EN on D100 mortality .


Secondary endpoints will compare EN and PN with regards to the main haematological , infectious and nutritional outcomes .


The impacts of nutritional support should exceed the limits of nutritional status improvement : EN may directly reduce immunological and infectious events , as well as decrease early transplant-related morbidity and mortality .


EN and PN need to be prospectively compared in order to assess their impacts and to provide treatment guidelines .


( Clinical trials gov number : NCT01955772 ; registration : July 19th , 2013 ) .


Butter is known to have a cholesterol-raising effect and , therefore , has often been included as a negative control in dietary studies , whereas the effect of moderate butter intake has not been elucidated to our knowledge .


We compared the effects of moderate butter intake , moderate olive oil intake , and a habitual diet on blood lipids , high-sensitivity C-reactive protein ( hsCRP ) , glucose , and insulin .


The study was a controlled , double-blinded , randomized 2 5-wk crossover dietary intervention study with a 14-d run-in period during which subjects consumed their habitual diets .


The study included 47 healthy men and women ( mean SD total cholesterol : 5.22 0.90 mmol/L ) who substituted a part of their habitual diets with 4.5 % of energy from butter or refined olive oil .


Study subjects were 70 % women with a mean age and body mass index ( in kg/m ) of 40.4 y and 23.5 , respectively .


Butter intake increased total cholesterol and LDL cholesterol more than did olive oil intake ( P < 0.05 ) and the run-in period ( P < 0.005 and P < 0.05 , respectively ) and increased HDL cholesterol compared with the run-in period ( P < 0.05 ) .


No difference in effects was observed for triacylglycerol , hsCRP , insulin , and glucose concentrations .


The intake of saturated fatty acids was significantly higher in the butter period than in the olive oil and run-in periods ( P < 0.0001 ) .


Moderate intake of butter resulted in increases in total cholesterol and LDL cholesterol compared with the effects of olive oil intake and a habitual diet ( run-in period ) .


Furthermore , moderate butter intake was also followed by an increase in HDL cholesterol compared with the habitual diet .


We conclude that hypercholesterolemic people should keep their consumption of butter to a minimum , whereas moderate butter intake may be considered part of the diet in the normocholesterolemic population .


Myofascial trigger points ( MTrPs ) are focal disruptions in the skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type HA ( TTH ) .


The present study applied massage focused on MTrPs of patients with TTH in a placebo-controlled , clinical trial to assess efficacy on reducing headache ( HA ) pain .


Fifty-six patients with TTH were randomized to receive 12 massage or placebo ( detuned ultrasound ) sessions over 6 weeks , or to wait-list .


Trigger point release massage focused on MTrPs in cervical musculature .


HA pain ( frequency , intensity , and duration ) was recorded in a daily HA diary .


Additional outcome measures included self-report of perceived clinical change in HA pain and pressure-pain threshold at MTrPs in the upper trapezius and suboccipital muscles .


From diary recordings , group differences across time were detected in HA frequency ( P = 0.026 ) , but not for intensity or duration .


Post hoc analysis indicated that HA frequency decreased from baseline for both massage ( P < 0.0003 ) and placebo ( P = 0.013 ) , but no difference was detected between massage and placebo .


Patient report of perceived clinical change was greater reduction in HA pain for massage than placebo or wait-list groups ( P = 0.002 ) .


Pressure-pain threshold improved in all muscles tested for massage only ( all P 's < 0.002 ) .


Two findings from this study are apparent : ( 1 ) MTrPs are important components in the treatment of TTH , and ( 2 ) TTH , like other chronic conditions , is responsive to placebo .


Clinical trials on HA that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention .


To evaluate the efficacy and safety of combination therapy of sildenafil plus vacuum erection devices in men with type 2 diabetes mellitus with moderate to severe erectile dysfunction who are dissatisfied with the results of using sildenafil alone .


The study included 66 diabetes mellitus patients presenting erectile dysfunction for at least 6 months and dissatisfied with the use of 100 mg sildenafil monotherapy .


The patients were randomized in two groups .


Those in group A ( n = 33 ) were instructed to use a vacuum erection device only , whereas those in group B ( n = 33 ) were treated with combination therapy , including sildenafil 100 mg and a vacuum erection device .


Erectile function was evaluated subjectively using the International Index of Erectile Function , Sexual Encounter Profile questionnaire questions 2 and 3 at visit 1 ( baseline ; study entry ) , visit 2 ( 4 weeks after baseline ) , and visit 3 ( 12 weeks after baseline ; study end ) .


There were no significant differences in average patient age , duration of diabetes , duration of erectile dysfunction , baseline International Index of Erectile Function scores , hypertension , blood testosterone , smoking and alcohol consumption between two groups .


Mean International Index of Erectile Function scores were significantly higher for group B at the 1-month ( 14.86 2.17 vs 12.41 2.63 ; P < 0.0001 ) and 3-months ( 17.53 2.95 vs 14.29 2.81 ; P < 0.0001 ) visits .


Men in group B had better successful penetration ( 73.3 % vs 46.6 % ) and successful intercourse ( 70 % vs 46.6 % ) at 3 months compared with group A.


Combined use of sildenafil and vacuum erection device therapy significantly enhances erectile function , and it is well tolerated by diabetes mellitus patients not responding to first-line sildenafil alone .


Direct health provider to patient presentation of coronary computed tomography angiography findings may increase adherence to preventive therapy and risk modification .


The purpose of this study was to assess the influence of visualization of coronary artery calcification and lifestyle recommendations on cholesterol concentrations and other risk variables in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia .


We performed a prospective 2-center randomized controlled trial .


Patients were randomized 1:1 to intervention or standard follow-up in general practice .


The primary end point was change in plasma total cholesterol concentration at 6 months follow-up .


We included 189 patients ( mean [ standard deviation ] age 61 [ 12 ] years , 57 % were male ) .


Median ( range ) Agatston score was 166 ( 70-2054 ) .


The reduction in plasma total cholesterol concentrations tended to be higher in the intervention group than in the control group , 51.04 mg/dL versus 45.63 mg/dL ( P = .181 ) .


In a subgroup including patients continuing statin therapy during follow-up ( n = 147 ) , the reduction in plasma total cholesterol concentrations was more pronounced in the intervention group than in the control group , 66.13 mg/dL versus 55.68 mg/dL ( P = .027 ) .


In the intervention group , there was a higher degree of statin adherence and a higher proportion of patients who stopped smoking and commenced healthier dietary behavior than in the control group .


Visualization of coronary artery calcification and brief recommendations about risk modification after coronary computed tomography angiography in symptomatic patients with nonobstructive coronary artery disease and hyperlipidemia may have a favorable influence on plasma total cholesterol concentration , adherence to statin therapy , and risk behavior .


Further investigations are needed .


Inguinal hernia is the commonest type of external hernias .


Lichtenstein mesh repair is the most favoured technique of inguinal hernia repair nowadays .


It is tension free repair of weakened inguinal wall using polypropylene mesh .


The present study was conducted to determine the efficacy of single dose antibiotic with placebo on patients undergoing inguinal hernia mesh repair .


This randomised controlled trial was carried out in the Department of General Surgery , Ayub Teaching Hospital , Abbottabad from January to December 2011 .


The study population included male patients presenting with primary unilateral inguinal hernia , above 18 years of age .


Mesh repair was performed in all patients .


The patients were randomly divided into two groups .


Patients in group A were given a single dose of antibiotic before inguinal hernia mesh repair and patients in group B were given placebo before inguinal hernia mesh repair .


Efficacy of antibiotic and placebo was accessed in terms of surgical site infections ( SSIs ) .


A total of 166 cases of inguinal hernia mesh repair patients were recorded during the study period .


A total of 83 patients were recruited in each group .


Surgical site infection was found in 6 ( 7.2 % ) in Group B it was 15 ( 18.1 % ) .


The difference being statistically significant ( p = 0.036 ) .


Antibiotic prophylaxis is a preferred option for mesh plasty .


The purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test ( FIT + ) for a total colonoscopy ( TC ) .


FIT + patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and , for non-compliers , to be recalled by mail , for counselling with a general practitioner , or to meet with a specialist screening practitioner ( nurse or healthcare assistant ) .


In all , 3777 patients were randomised to different invitation strategies .


Compliance with an initial invitation by mail and by phone was similar ( 86.0 % vs. 84.0 % , relative risk - RR : 1.02 ; 95 % CI 0.97-1 .08 ) .


Among non-responders to the initial invitation , compliance with a recall by appointment with a specialist practitioner was 50.4 % , significantly higher than with a mail recall ( 38.1 % ; RR :1.33 ; 95 % CI 1.01-1 .76 ) or with a face-to-face counselling with the GP ( 30.8 % ; RR :1.45 ; 95 % CI 1.14-1 .87 ) .


Compliance with an initial invitation for a TC by mail and by phone was similar .


A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations , while the involvement of GPs in this particular activity seemed less effective .


The aim of this study was to determine the effect of combined calcium and iron versus single iron supplementation on iron status in Bolivian schoolchildren .


Children ages 6 to 10 y old ( N = 195 ) , were randomly assigned to receive either 700 mg Ca ( as calcium carbonate ) plus 30 mg Fe ( as ferrous sulfate ) ( Ca + Fe group ) or 30 mg Fe ( as ferrous sulfate ) ( Fe group ) .


The doses were administered daily , from Monday to Friday , between meals at school over 3 mo. .


Iron status was assessed at baseline and after intervention .


Additionally , overall nutritional status was assessed by anthropometry and an estimation of dietary intake .


At baseline , the prevalence of anemia in the Ca + Fe group and the Fe group were 15 % and 21.5 % , respectively .


After 3 mo follow-up , the prevalence of iron deficiency anemia dropped significantly ( P < 0.001 ) to 3 % in both groups ( ( 2 ) = NS ) .


Iron dietary intake was within recommended levels , but calcium intake only covered 39 % of the Recommended Daily Intake .


Combined calcium and iron supplementation is equally as effective as single iron supplementation in reducing the prevalence of iron deficiency anemia in Bolivian school children .


The efficacy and safety of primary intraocular lens ( IOL ) implantation during early infancy is unknown .


To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy .


The Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites .


A traveling examiner assessed visual acuity at age 4.5 years .


Cataract surgery with or without primary IOL implantation .


Contact lenses were used to correct aphakia in patients who did not receive IOLs .


Treatment was determined through random assignment .


HOTV optotype visual acuity at 4.5 years of age .


The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups ( both , 0.90 [ 20/159 ] ; P = .54 ) .


About 50 % of treated eyes in both groups had visual acuity less than or equal to 20/200 .


Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery ( contact lens , 56 % ; IOL , 81 % ; P = .02 ) .


The most common adverse events in the IOL group were lens reproliferation into the visual axis , pupillary membranes , and corectopia .


Glaucoma/glaucoma suspect occurred in 35 % of treated eyes in the contact lens group vs 28 % of eyes in the IOL group ( P = .55 ) .


Since the initial cataract surgery , significantly more patients in the IOL group have had at least 1 additional intraocular surgery ( contact lens , 21 % ; IOL , 72 % ; P < .001 ) .


There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic .


However , there were significantly more adverse events and additional intraoperative procedures in the IOL group .


When operating on an infant younger than 7 months of age with a unilateral cataract , we recommend leaving the eye aphakic and focusing the eye with a contact lens .


Primary IOL implantation should be reserved for those infants where , in the opinion of the surgeon , the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia .


clinicaltrials.gov Identifier : NCT00212134


In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve .


Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered .


In addition to all these procedures mentioned above , one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A ( BTX-A ) .


We conducted a randomized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A .


Eighty four patients were randomized into following groups : placebo ( n = 28 ) ; BTX-A 25U ( n = 27 ) ; BTX-A 75U ( n = 29 ) .


Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8weeks to observe the pain severity , efficacy and adverse reactions at endpoint .


The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study .


There was no significant difference in VAS between 25U and 75U groups throughout the study .


The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups .


Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ` much improved ' or ` very much improved ' versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups .


All adverse reactions were graded as mild or moderate .


BTX-A injection in TN is safe and efficient .


It is a useful treatment for refractory TN .


Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term .


This study was aimed to explore the physiological changes and the effect of heat acclimation training via a randomized control trial study .


Forty healthy male volunteers were chosen and divided into experimental group and control group randomly .


Those in experimental group received heat acclimation training including but not limited to meditation , unarmed run , yoga , and stepping in hot lab environment .


And then , subjective feeling , rectal temperature , average skin temperature , and sweat electrolytes concentration were detected in order to describe their physiological changes .


Before and after the training , both groups received some tests and their 3 000 m run-race time , nervous reaction time and subjective perception scores were recorded to evaluate the effect of acclimation training .


( 1 ) There was no difference in 3 000 m between the 2 groups in the same environment .


Subjects ' 3 000 m race time in experimental group was obviously shortened than that in control group in room temperature environment ( t = 2.326 , P < 0.05 ) .


And subjects ' 3 000 m race time in experimental group was obviously shortened than that in control group in hot-humid environment ( t = 4.518 , P < 0.01 ) .


( 2 ) Subjects ' reaction time ( RT ) in experimental group was shortened than that in control group in room temperature environment ( Z = 11.258 , P < 0.05 ) .


And Subjects ' RT in experimental group was sharply shortened than that in control group in hot-humid environment ( Z = 6.519 , P < 0.01 ) .


( 3 ) No difference between the experimental and control groups was observed in subjective perception score ( SPS ) in room temperature environment .


But subjects ' SPS in experimental group was obviously lowered than that in control group and in hot-humid environment ( t = 17.958 , P < 0.01 ) .


( 4 ) Anal temperature ( AT ) was lowered during training , while the change of mean skin temperature ( MST ) was not significant .


Sweat sodium concentration ( SSC ) was lowered during training .


SPS continued to decrease and entered plateau on the 13th day after training .


( 5 ) After acclimation training , the working capacity of the experimental group in hot-humid environment was over 85 % of that in room temperature environment .


While subjects ' working capacity in control group in hot-humid environment was about 80 % of that in room temperature environment .


Hot-humid environment acclimation training improved the working capacity .


After training , subjects ' working capacity in hot-humid environment remained over 85 % of that in room temperature environment , which was higher than that of those subjects who did not take part in training .


The mammalian skin is a barrier that effectively separates the water-rich interior of the body from the normally dryer exterior .


Changes in the external conditions , for example ambient humidity , have been shown to affect the skin barrier properties .


The prime objective of this study was to evaluate the effect of water activity of a topical formulation on skin hydration and permeability .


A second objective was to gain more understanding on how two commonly used humectants , urea and glycerol , affect skin barrier function in vivo .


Simple aqueous formulations were applied under occlusion to the volar forearm of healthy volunteers .


Following 4-h exposure , skin water loss ( by transepidermal water loss measurements ) , skin hydration ( by Corneometry ) and skin permeability ( by time to vasodilation due to benzyl nicotinate exposure ) were monitored .


The results demonstrate that a relatively small change in the water activity of a topical formulation is sufficient to induce considerable effects on stratum corneum hydration and permeability to exogenous substances .


Exposing the skin to high water activity leads to increased skin hydration and also increased permeability .


Furthermore , urea and glycerol promote skin hydration and permeability even at reduced water activity of the applied formulation .


These results highlight the importance of considering the water activity in topically applied formulations and the potential benefit of using humectants .


The results may impact formulation optimization in how to facilitate skin hydration and to modify skin permeability by temporarily open and close the skin barrier .


Internet - and mobile based stress-management interventions ( iSMI ) may be an effective means to address the negative consequences of occupational stress .


However , available results from randomised controlled trials are conflicting .


Moreover , it is yet not clear whether guided or unguided self-help iSMI provide better value for money .


Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional .


However , direct comparisons in randomised controlled trials are scarce and , to the best of our knowledge , the comparative ( cost ) - effectiveness of guided vs. unguided iSMI has not yet been studied .


Hence , this study investigates the acceptability and ( cost - ) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress .


A three-armed randomised controlled trial ( RCT ) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition ( WLC ) .


Both active conditions are based on the same iSMI , i.e. GET.ON Stress , and differ only with regard to the guidance format .


Employees with heightened levels of perceived stress ( PSS 22 ) will be randomised to one of three conditions .


Primary outcome will be comparative changes in perceived stress ( PSS ) .


Secondary outcomes include changes in self-reported depression , work-engagement , presenteeism and absenteeism .


Moreover , a cost-effectiveness analysis will be conducted from a societal perspective , including both direct medical costs and costs related to productivity losses .


In addition , a cost-benefit analysis will be conducted from the employer 's perspective .


Incremental net-benefit regression analyses will address the question if there are any baseline factors ( i.e. subgroups of employees ) associated with particularly favorable cost-effectiveness when the experimental intervention is offered .


Assessments take place at baseline , 7 weeks post-treatment and 6 months after randomisation .


Online-based ( guided ) self-help interventions could be an acceptable , effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress .


This study evaluates the ( cost - ) effectiveness of two versions of an iSMI , minimal guided and unguided iSMI .


Thus , the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs .


German Clinical Trial Registration ( DRKS ) : DRKS00005687 .


The aim of this study was to examine the putative adverse effects of ambient fine particulate matter ( PM2 .5 : PM with aerodynamic diameters < 2.5 m ) on brain volumes in older women .


We conducted a prospective study of 1,403 community-dwelling older women without dementia enrolled in the Women 's Health Initiative Memory Study , 1996-1998 .


Structural brain magnetic resonance imaging scans were performed at the age of 71-89 years in 2005-2006 to obtain volumetric measures of gray matter ( GM ) and normal-appearing white matter ( WM ) .


Given residential histories and air monitoring data , we used a spatiotemporal model to estimate cumulative PM2 .5 exposure in 1999-2006 .


Multiple linear regression was employed to evaluate the associations between PM2 .5 and brain volumes , adjusting for intracranial volumes and potential confounders .


Older women with greater PM2 .5 exposures had significantly smaller WM , but not GM , volumes , independent of geographical region , demographics , socioeconomic status , lifestyles , and clinical characteristics , including cardiovascular risk factors .


For each interquartile increment ( 3.49 g/m ( 3 ) ) of cumulative PM2 .5 exposure , the average WM volume ( WMV ; 95 % confidence interval ) was 6.23 cm ( 3 ) ( 3.72-8 .74 ) smaller in the total brain and 4.47 cm ( 3 ) ( 2.27-6 .67 ) lower in the association areas , equivalent to 1 to 2 years of brain aging .


The adverse PM2 .5 effects on smaller WMVs were present in frontal and temporal lobes and corpus callosum ( all p values < 0.01 ) .


Hippocampal volumes did not differ by PM2 .5 exposure .


PM2 .5 exposure may contribute to WM loss in older women .


Future studies are needed to determine whether exposures result in myelination disturbance , disruption of axonal integrity , damages to oligodendrocytes , or other WM neuropathologies .


A randomized , controlled clinical trial .


This randomized controlled clinical trial was aimed at comparing the clinical outcomes of combined posteroanterior ( P-A ) fusion and transforaminal thoracic interbody fusion ( TTIF ) in cases of thoracolumbar fracture-dislocation .


The optimal treatment strategy for thoracolumbar fracture-dislocation remains controversial .


Sixty-one patients presenting with acute fracture-dislocation of the thoracolumbar joint between March 2010 and December 2011 were enrolled and randomly assigned to the P-A or TTIF group .


The radiological outcome was assessed by acquiring radiographs in the standing position and computed tomographic scans .


The clinical outcome was measured in terms of the American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index .


Moreover , we assessed the severity of overall morbidity and morbidity at the donor site in the 2 patient groups .


The Student t and tests were used for the analysis of independent variables and categorical data , respectively .


Only 57 of the enrolled patients were available for the required 24-month follow-up period , 27 underwent TTIF and 30 underwent P-A fusion .


Both treatments were similar with respect to the fusion rate , extent of decompression , loss of correction , rate of instrumentation failure , American Spinal Injury Association score , visual analogue scale score , and Oswestry Disability Index ( P > 0.05 ) .


However , the blood loss , operating time , and rate of perioperative complications were greater in the P-A group than in the TTIF group ( P < 0.05 ) .


The clinical and radiological outcomes were similar for both the treatment procedures .


However , our findings suggest that TTIF allows for safe interbody fusion and circumferential decompression , requires only a posterior approach , and is associated with a lower incidence of surgery-related complications .


2 .


To evaluate the follow-up efficacy and safety on slow transit constipation ( STC ) treated with individualized deep puncture at Tianshu ( ST 25 ) .


One hundred and twenty-eight cases of STC were randomized into a deep puncture group ( 64 cases ) , a western medication group ( 31 cases ) and a shallow puncture group ( 33 cases ) at the ratio of 2:1:1 .


In the deep puncture group , electroacupuncture of deep puncture was applied to bilateral Tianshu ( ST 25 ) .


The needle was inserted perpendicularly and slowly at the acupoint and went deeply till penetrating the peritoneum , about 20 to 65 mm in depth .


In the western medication group , lactulose oral liquid was prescribed for oral administration .


In the shallow puncture group , electroacupuncture of shallow puncture was done at bilateral Tianshu ( ST 25 ) .


The needle was inserted perpendicularly and slowly , 5 to 8 mm in depth .


The treatment lasted 4 weeks in the three groups and the follow-up visit of 12 weeks and 6 month after treatment was performed respectively .


The weekly defecation frequency , patient 's satisfaction and safety of deep puncture at Tianshu ( ST 25 ) were assessed before and after treatment in each group .


In the deep puncture group , the weekly defecation frequency was ( 1.79 + / - 1.05 ) times/week before treatment and was ( 3.90 + / - 1.43 ) times/week after 4-week treatment .


It was ( 3.49 + / - 1.46 ) times/week in 12-week follow-up visit after treatment and was ( 3.51 + / - 1.42 ) times/week in 6-month follow-up visit after treatment .


In the deep puncture group , the improvements in weekly defecation frequency , patient 's satisfaction and short-term efficacy were same as those in the western medication group and the shallow puncture group ( all P > 0.05 ) .


The long-term efficacy in follow-up visit was better remarkably than that in the western medication group ( P < 0.05 , P < 0.01 ) .


Besides , the combined medication was reduced and no adverse reaction occurred .


The individualized deep puncture at Tianshu ( ST 25 ) is effective in the treatment of STC and achieves the satisfactory long-term efficacy .


This therapy displays the good effective advantage and deserves to be promoted in clinical practice of acupuncture and moxibustion therapeutic program as compared with the first-tier line of medication , lactulose oral liquid , recommended at home and abroad , in terms of the evidence-based medicine .


Participant retention is an important challenge in longitudinal research on homeless people .


High attrition can threaten validity , and may represent lost opportunities to deliver interventions .


In this article , we report on attrition in the At Home/Chez Soi study , a multi-site randomized controlled trial of a housing intervention for homeless people with mental illness .


We first calculate life tables , and then use clustered logistic regression to implement a discrete-time survival model .


We use splines and indicator variables to capture non-linear and group-specific variation over time in the hazard function .


As potential predictors , we consider study group , site , date of recruitment , age , sex , baseline substance dependence , baseline psychotic disorder , time homeless in life , community functioning , and education .


The study recruited 2,148 homeless people with mental illness .


Of these , 1,158 were randomized to the housing first intervention ( HF ) , and 990 to treatment as usual ( TAU ) .


Excluding 79 people known to have died , attrition was 14 % .


This proportion was higher in TAU than in HF ( 21 vs. 8 % , p < 0.01 ) .


Attrition was significantly lower in one site than elsewhere , and was also lower among those with substance dependence ( 13 vs. 18 % , p < 0.01 ) and among those enrolled earlier in the study .


The hazard varied over time in complex ways .


Results imply that study factors are more important than participant characteristics as determinants of retention , and that the immediate period after randomization is a crucial one .


The high overall retention demonstrates the effectiveness of existing techniques for retaining participants .


The main objective of the present work was to compare the effects of the gonadotropin-releasing hormone agonist ( GnRH-a ) and GnRH antagonist ( GnRH-ant ) on the gene expression profiles of oocytes obtained from Iranian infertile couples undergoing in vitro fertilization ( IVF ) .


Fifty infertile couples who underwent IVF between June 2012 and November 2013 at the Infertility Center of Tehran Women General Hospital , Tehran University of Medical Sciences , were included in this study .


We included women that had undergone IVF treatment because of male factor , tubal factor , or unexplained infertility .


The women randomly underwent controlled ovarian stimulation ( COS ) with either the GnRH-a ( n = 26 ) or the GnRH-ant ( n = 24 ) .


We obtained 50 germinal vesicle ( GV ) oocytes donated by women in each group .


After the sampling , pool of 50 GV oocytes for each group was separately analyzed by quantitative polymerase chain reaction ( qPCR ) .


The expression levels of Adenosine triphosphatase 6 ( ATPase 6 ) , Bone morphogenetic protein 15 ( BMP15 ) , and Neuronal apoptosis inhibitory protein ( NAIP ) genes were significantly upregulated in the GnRH-ant group compared to the GnRH-a group , with the fold change of 3.990 ( SD 1.325 ) , 6.274 ( SD 1.542 ) , and 2.156 ( SD 1.443 ) , respectively , ( P < 0.001 ) .


Growth differentiation factor 9 ( GDF9 ) mRNA did not have any expression in the GnRH-a group ; however , GDF9 mRNA was expressed in the GnRH-ant group .


Finally , it was found that the genes involved in the DNA repairing and cell cycle checkpoint did not have any expression in either group .


The present study showed , for the first time , the expression levels of genes involved in the cytoplasmic maturity ( BMP15 , GDF9 ) , adenosine triphosphate production ( ATPase 6 ) , and antiapoptotic process ( NAIP ) , in human GV oocytes were significantly higher in the GnRH-anta group than in the GnRH-a group in COS. .


Higher expression level of these genes when GnRH-ant protocol is applied , this protocol seems to be a more appropriate choice for women with poly cystic ovarian syndrome , because it can probably improve the expression of the aforementioned genes .


Current Controlled Trials : IRCT 2014031112307 N3 .


Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia ( TN ) .


The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN .


This was a randomized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN .


Patients received a one-time subcutaneous administration of BTX-A using `` follow the pain '' method .


The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) .


Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint .


Pain reduction at the 12-week endpoint was significant in BTX-A group ( p < 0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale .


These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases .


Hydroxyethyl starch ( HES ) 130/0 .4 is considered an effective plasma expander when compared to crystalloids .


There is controversy around its superiority regarding hemodynamic optimization and about possible detrimental effects on coagulation .


The aim of this study was to compare the effects of HES 130/0 .4 to lactated Ringer solution during hip arthroplasty in adult patients under spinal anesthesia regarding intraoperative bleeding , hemodynamic parameters , coagulation profile , transfusion requirements and clinical outcomes .


In this randomized , controlled trial , 48 patients scheduled for hip arthroplasty with spinal anesthesia were randomized into two groups : 24 patients were allocated to receive a preload of 15 mL.kg ( -1 ) of HES 130/0 .4 and 24 patients received a preload of 30 mL.kg ( -1 ) lactated Ringer solution before surgery .


Hemodynamic measurements , hemoglobin concentrations , biochemical parameters and coagulation tests were evaluated in three periods during surgical procedure .


Patients received medical follow-up during their hospital stay and up to postoperative 30 days .


Primary outcome was the requirement of red blood cell transfusion between groups during hospital stay .


Secondary outcome were hemodynamic parameters , length of hospital stay , mortality and occurrence of clinical postoperative complications .


Red blood cell transfusion was required in 17 % of patients in the HES group and in 46 % in the Ringer group ( p = .029 ) .


Postoperative infections were more frequently observed in the Ringer group ( 17 % ) compared to the HES group ( 0 ) , p = .037 .


There were no significant differences between groups in mortality , hospital length of stay and clinical complications other than infection .


During hip arthroplasty , patients treated with hypervolemic hemodilution with hydroxyethyl starch 130/0 .4 required less transfusion and presented lower infection rate compared to patients who received lactated Ringer .


The use of ecstasy is a public health problem and is associated with a range of social costs and harms .


In recent years , there has been growing concern about the availability and misuse of new and emerging drugs designed to mimic the effects of illicit drugs , including ecstasy .


This , coupled with the fact that the age of use and the risk factors for using ecstasy and emerging drugs are similar , provides a compelling argument to implement prevention for these substances simultaneously .


The proposed study will evaluate whether a universal Internet-based prevention program , known as the Climate Schools : Ecstasy and Emerging Drugs Module , can address and prevent the use of ecstasy and emerging drugs among adolescents .


A cluster randomised controlled trial will be conducted among Year 10 students ( aged 15-16 years ) from 12 secondary schools in Sydney , Australia .


Schools will be randomly assigned to either the Climate Schools intervention group or the control group .


All students will complete a self-report questionnaire at baseline , immediately post-intervention , and 6 - , 12 - and 24-months post-baseline .


The primary outcome measures will include ecstasy and emerging drug-related knowledge , intentions to use these substances in the future , and the patterns of use of ecstasy and emerging drugs .


A range of secondary outcomes will also be assessed , including beliefs and attitudes about ecstasy and emerging drugs , peer pressure resistance , other substance use and mental health outcomes .


To our knowledge , this will be the first evaluation of an Internet-based program designed to specifically target ecstasy and NED use among adolescents .


If deemed effective , the Climate Schools : Ecstasy and Emerging Drugs Module will provide schools with an interactive and novel prevention program for ecstasy and emerging drugs that can be readily implemented by teachers .


This trial is registered with the Australian New Zealand Clinical Trials Registry , ACTRN12613000708752 .


To assess the effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy , and describe the technique in detail .


A randomized , double-blind , placebo-controlled study following the CONSORT criteria .


A university hospital .


Thirty-seven patients undergoing vaginal hysterectomy .


Patients received high-volume ( 50mL ) ropivacaine 0.50 % ( n = 20 ) or saline ( n = 17 ) infiltration using a systematic technique ensuring uniform delivery to all tissues incised , handled or instrumented during the procedure .


Pain , nausea , vomiting and opioid requirements were assessed for 32 h as well as time spent in the post-anesthesia care unit and time to first mobilization .


Pain at rest was significantly reduced after one , four and eight hours in the ropivacaine group ( p0.001-0 .01 ) .


Pain during coughing was significantly reduced after one and four hours ( p0 .001 and p0 .003 ) , and pain during movement was significantly reduced after four hours ( p0 .02 ) .


Opioid requirements and time spent in the post-anesthesia care unit were significantly reduced in the ropivacaine group ( p < 0.001 and p < 0.001 , respectively ) , as well as the time to first mobilization ( p < 0.001 ) .


Intra-operative systematic local infiltration analgesia reduces postoperative pain in patients undergoing vaginal hysterectomy , facilities mobilization and improves early recovery .


Impaired functional performance and decreased muscle strength and muscle atrophy generally persist for a long period after total hip arthroplasty ( THA ) .


To investigate the effects of weight-bearing ( WB ) and non-weight-bearing ( NWB ) exercises on functional performance , Harris hip score ( HHS ) , muscle strength and muscle thickness in women after THA .


A randomised , controlled trial .


Community .


Sixty-five women who had undergone unilateral or bilateral THA at least 6 months before enrolment in the study .


Participants were randomly allocated to the following groups : WB ( n = 22 ) , NWB ( n = 21 ) and control ( n = 22 ) groups .


Participants in the WB and NWB groups performed daily home exercise programs for 8 weeks .


Functional performance ( timed up and go , sit-to-stand , stair climbing , walking speed and 3-min walk test ) , HHS , isometric muscle strength of the hip and knee muscle and gluteus and quadriceps muscle thickness were measured at baseline and after 8 weeks .


An intention-to-treat analysis revealed that both the intervention groups exhibited significant improvements in almost all functional performance measures compared with the control group .


Furthermore , the WB group showed significantly greater pre-post changes in the sit-to-stand and 3-min walk test compared with the NWB group .


In terms of HHS , only the WB group showed significantly greater improvement compared with the control group .


Relative to the control group , improvements in all isometric strength measures were observed in both the intervention groups .


Significant improvement in quadriceps muscle thickness was observed in the WB group compared with the control group .


However , no significant difference was observed among the three groups in pre-post changes in gluteus muscle thickness .


WB and NWB home exercise programs were both effective for improving functional performance and muscle strength in women after THA .


However , the WB exercise was more effective than the NWB exercise for improving sit-to-stand ability and walking endurance .


In this study , we demonstrated that the WB exercise was more effective than the NWB exercise for improving functional performance in patients after THA .


To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug ( NSAID ) - refractory nonradiographic axial spondyloarthritis ( SpA ) .


The study population consisted of patients who met the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis ( as assessed by a radiologist at the central trial site ) , had a symptom duration of > 3 months but < 5 years , had a score of 4 on the Bath Ankylosing Spondylitis Disease Activity Index , and had been treated unsuccessfully with 2 NSAIDs .


Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks ( double-blind study ) ; during the subsequent open-label period , all patients received etanercept 50 mg/week .


The primary study end point was meeting the ASAS criteria for 40 % improvement ( ASAS40 ) at week 12 .


Magnetic resonance imaging ( MRI ) of the sacroiliac joints and spine was performed at baseline and week 12 .


One hundred six patients were randomized to the etanercept group and 109 to the placebo group .


Of the 215 patients , the mean SD age at baseline was 32.0 7.8 years , 154 ( 72 % ) were HLA-B27 positive , and 174 ( 81 % ) had MRI-confirmed sacroiliitis .


At 12 weeks , the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group ( 34 of 105 [ 32 % ] versus 17 of 108 [ 16 % ] ; P = 0.006 ) .


Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation ( -46.9 % versus -10.9 % ; P < 0.001 ) and spinal inflammation ( -45.4 % versus -33.4 % ; P = 0.04 ) compared with placebo-treated patients at week 12 .


Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept .


At week 24 , patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks .


In patients with nonradiographic axial SpA , etanercept treatment was associated with rapid , significant improvement in symptomatic disease activity , function , and systemic and skeletal inflammation over 12 weeks ; clinical/functional improvement was sustained over 24 weeks .


Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes .


TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results .


Aim of this non-inferiority study is to report the 5-year follow-up of a randomized , single-blind , controlled trial comparing TVT-O to TVT-Secur .


Randomized , single blind , controlled study conducted in two tertiary urogynecological centers .


154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination ( POP-Q staging , challenge stress test and post-void residual urine evaluation ) , to complete I-QOL and PGI-I questionnaires , and to score their satisfaction on a 5-point Likert scale .


Patients who were not objectively evaluated were interviewed over the telephone .


Primary outcome was subjective success defined as being `` very much improved '' or `` much improved '' on the PGI-I .


120 patients were evaluated only subjectively ( TVT-O : 62 ; TVT-Secur : 58 ) and 84 objectively and subjectively ( TVT-O : 46 ; TVT-Secur : 38 ) .


Subjective success ( 79 % vs. 63.8 % ) and objective cure rates ( 82.6 % vs. 68.4 % ) 5 years after the procedure were lower for TVT-Secur , but not significantly .


Recurrent UTIs were reported by 17.8 % of women ( TVT-O 9 , TVT-Secur 6 ) and two de novo urgency cases ( one per group ) were observed .


Re-operation rate for stress urinary incontinence ( SUI ) was 20 % .


TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure , even though displaying a clear trend toward a lower efficacy .


Considering that the long-term safety profile is similar between the two procedures , there are no advantages in using TVT-Secur .


People with rheumatoid arthritis are at greater risk of morbidity and mortality from cardiovascular disease than the general population .


Sustained physical activity increases cardio-respiratory fitness and reduces cardiovascular disease risk factors .


However , little is known about how we can effectively promote long-term participation in physical activity in patients with rheumatoid arthritis .


The literature consistently calls for physical activity interventions , and their implementation , to be theoretically-grounded .


This paper documents the protocol of a randomised control trial that investigates whether a Self-determination Theory-based intervention fosters the adoption and maintenance of physical activity ( 3 , 6 and 12 months ) sufficient to provide sustained cardiovascular and personal well-being benefits in patients with rheumatoid arthritis .


The cost effectiveness of the intervention will also be determined .


The trial is registered as Current Controlled Trials ISRCTN04121489 .


Results from this trial will provide guidance regarding key social environmental factors that can be manipulated to support motivational processes conducive to positive health behaviour change and optimal functioning in patients with Rheumatoid Arthritis .


This study aimed to assess changes in oral health-related quality of life ( OHRQoL ) in individuals enroled in a double-blind randomized clinical trial conducted to evaluate the efficacy and safety of two carbamide peroxide concentrations used in at-home vital bleaching in the city of Pelotas , Southern Brazil .


Ninety-two volunteers with a shade mean of C1 or darker for the six maxillary anterior teeth were randomized into two balanced groups ( n = 46 ) according to bleaching agent concentration : 10 % or 16 % carbamide peroxide .


The patients were instructed to use the whitening agent in a tray for 2h once a day for three weeks .


To assess changes in OHRQoL , participants completed the oral impact on daily performance ( OIDP ) at the start and one week after the completion of treatment .


Because there was no difference with regard to whitening effect or tooth sensitivity during or after treatment the two groups were merged for the analyses of the current article .


Before-and-after changes in OIDP scores were assessed by chi-square and McNemar tests ( p < 0.05 ) .


Mean pre - and post-treatment OIDP scores varied from 0.42 to 0.60 .


When the frequency of impacts for different activities were compared , there was an increase in difficulty in cleaning teeth ( p = 0.02 ) and a significant reduction in smiling and showing teeth with embarrassment ( p = 0.03 ) .


Regarding the symptoms and main oral conditions that generated impact , there was higher number of participants reporting pain ( p = 0.05 ) after treatment .


In opposite , significant decrease was observed in individuals reporting being unhappy with their appearance ( p = 0.03 ) .


On the contrary , it was showed a decrease in impacts resulting from dental colour was observed after bleaching ( p = 0.03 ) .


Quality of life is complex and encompasses different domains .


Although positive impact of the dental bleaching was detected , with patients showing more their teeth without embarrassment , difficult in dental hygiene and pain resulting from the treatment were also reported , and this can negatively impact daily performances .


Dentists must consider these aspects when performing aesthetics procedures .


The long-term efficacy of microwave hyperthermia combined with chemoradiotherapy in treating nasopharyngeal carcinoma ( NPC ) with metastatic foci in cervical lymph nodes was evaluated .


A total of 154 cases of N2 or N3 stage NPC were randomized into two groups : hyperthermia group ( 76 cases ) and control group ( 78 cases ) .


Both received cisplatin chemotherapy and radiotherapy .


In addition , the hyperthermia group further received microwave hyperthermia to the metastatic cervical nodes with different patterns ( before or after radiotherapy ) , heating temperatures ( T90 < 43 and T90 43 ) and hyperthermia episodes ( < 4 times , 4-10 times and > 10 times ) .


The 3-month and 5-year complete response ( CR ) rates of cervical lymph nodes in the hyperthermia group were significantly higher than those in the control group .


The 5-year disease-free survival ( DFS ) rate and the 3-year / 5-year overall survival rate in the hyperthermia group were also significantly higher .


There was no significant difference in 5-year metastatic rates .


In the hyperthermia group , the 3-month and 5-year CR rates of T90 < 43 treatment were significantly lower than with T90 43 treatment .


The CR rate was highest when the hyperthermia was performed 4-10 times .


There were no significant differences in 3-month and 5-year CR rates between hyperthermia before or after radiotherapy treatment .


Microwave hyperthermia combined with chemoradiotherapy can increase local control , DFS and 3 , 5-year overall survival rates of patients with N2 ~ N3 stage NPC .


The heating temperature should be over 43 with hyperthermia repeated 4-10 times .


Bariatric surgery may be beneficial in mildly obese patients with poorly controlled diabetes .


The optimal procedure to achieve diabetes remission is unknown .


In 2011 , we published the short-term results of a pilot study designed to evaluate the efficacy of diabetic control and the role of duodenal exclusion in mildly obese diabetic patients undergoing laparoscopic sleeve gastrectomy ( SG ) vs. a laparoscopic single anastomosis ( mini - ) gastric bypass ( SAGB ) .


This study analyzes the 5-year results and evaluates the incretin effect .


A double-blind randomized trial included 60 participants with a hemoglobin A1c ( HbA1c ) level higher than 7.5 % , a body mass index ( BMI ) between 25 and 35 Kg/m ( 2 ) , a C-peptide level 1.0 ng/mL , and a diagnosis of type 2 diabetes mellitus ( T2DM ) for at least 6 months .


A SAGB with duodenal exclusion or a SG without duodenal exclusion was performed .


The 5-year results of the primary outcome were as an intention-to-treat analysis for HbA1c 6.5 % without glycemic therapy .


Assessments of the incretin effect and cell function were performed at baseline and between 36 and 60 months .


The patients were randomly assigned to SAGB ( n = 30 ) and SG ( n = 30 ) .


At 60 months , 18 participants ( 60 % ; 95 % confidence interval ( CI ) , 42 to 78 % ) in the SAGB group and nine participants ( 30 % ; 95 % CI , 13 to 47 % ) in the SG group achieved the primary end points ( odds ratio ( OR ) , 0.3 ; 95 % CI , 0.1 to 0.8 % ) .


The participants assigned to the SAGB procedure had a similar percentage of weight loss as the SG patients ( 22.85.9 vs. 20.15.3 % ; p > 0.05 ) but achieved a lower level of HbA1c ( 6.10.7 vs. 7.11.2 % ; p < 0.05 ) than the SG patients .


There was a significant increase in the incretin effect before and after surgery in both groups , but the SAGB group had a higher incretin effect than the SG group at 5 years .


In mildly obese patients with T2DM , SG is effective at improving glycemic control at 5 years , but SAGB was more likely to achieve better glycemic control than SG and had a higher incretin effect compared to SG .


We evaluated the effectiveness of a low-intensity , home-based physical activity program ( Onco-Move ) and a moderate - to high-intensity , combined supervised resistance and aerobic exercise program ( OnTrack ) versus usual care ( UC ) in maintaining or enhancing physical fitness , minimizing fatigue , enhancing health-related quality of life , and optimizing chemotherapy completion rates in patients undergoing adjuvant chemotherapy for breast cancer .


We randomly assigned patients who were scheduled to undergo adjuvant chemotherapy ( N = 230 ) to Onco-Move , OnTrack , or UC .


Performance-based and self-reported outcomes were assessed before random assignment , at the end of chemotherapy , and at the 6-month follow-up .


We used generalized estimating equations to compare the groups over time .


Onco-Move and OnTrack resulted in less decline in cardiorespiratory fitness ( P < .001 ) , better physical functioning ( P .001 ) , less nausea and vomiting ( P = .029 and .031 , respectively ) and less pain ( P = .003 and .011 , respectively ) compared with UC .


OnTrack also resulted in better outcomes for muscle strength ( P = .002 ) and physical fatigue ( P < .001 ) .


At the 6-month follow-up , most outcomes returned to baseline levels for all three groups .


A smaller percentage of participants in OnTrack required chemotherapy dose adjustments than those in the UC or Onco-Move groups ( P = .002 ) .


Both intervention groups returned earlier ( P = .012 ) , as well as for more hours per week ( P = .014 ) , to work than the control group .


A supervised , moderate - to high-intensity , combined resistance and aerobic exercise program is most effective for patients with breast cancer undergoing adjuvant chemotherapy .


A home-based , low-intensity physical activity program represents a viable alternative for women who are unable or unwilling to follow the higher intensity program .


Distress and pain associated with immunisation are significant problems for children , carers and healthcare professionals .


This study was designed to determine whether distraction by watching cartoons during immunisation could reduce the distress and pain perceived by the children .


A sample of 35 six year olds was randomly assigned to one of two groups : the first was distracted by standard techniques during immunisation , the second by watching cartoons .


Levels of distress were measured with the amended observation scale of behavioural distress , and of pain by the Wong-Baker FACES pain rating scale .


The levels of distress were significantly lower in the group distracted by cartoons compared with children who received traditional distraction techniques during immunisation .


By using an easy , cheap intervention , children 's first introduction to health services can be made a positive experience which will decrease the number developing pre-procedural anxiety or a fear of needles .


To assess for the frequency of binge eating behavior and its association with weight loss in an overweight/obese sample of veterans .


This study is a secondary analysis of data from the ASPIRE study , a randomized effectiveness trial of weight loss among veterans .


Of the 481 enrolled veterans with overweight/obesity , binge eating frequency was obtained by survey for 392 ( 82 % ) .


The majority ( 77.6 % ) reported binge eating , and 6.1 % reported high-frequency binge eating .


Those reporting any binge eating lost 1.4 % of body weight , decreased waist circumference by 2.0 cm , and had significantly worse outcomes than those reporting never binge eating who lost about double the weight ( 2.7 % ) and reduced waist circumference by twice as much ( 4.2 cm ) .


The high-frequency binge group gained 1.4 % of body weight and increased waist circumference by 0.3 cm .


High rates of binge eating were observed in an overweight/obese sample of veterans enrolled in weight loss treatment .


The presence of binge eating predicted poorer weight loss outcomes .


Furthermore , high-frequency binge eating was associated with weight gain .


These findings have operational and policy implications for developing effective strategies to address binge eating in the context of behavioral weight loss programs for veterans .


Urinary tract infections ( UTIs ) are common drivers of antibiotic use .


The minimal effective duration of antibiotic therapy for UTIs is unknown , but any reduction is important to diminish selection pressure for antibiotic resistance , costs , and drug-related side-effects .


The aim of this study was to investigate whether an algorithm based on procalcitonin ( PCT ) and quantitative pyuria reduces antibiotic exposure .


From April 2012 to March 2014 , we conducted a factorial design randomized controlled open-label trial .


Immunocompetent adults with community-acquired non-catheter-related UTI were enrolled in the emergency department of a tertiary-care 600-bed hospital in northwestern Switzerland .


Clinical presentation was used to guide initiation and duration of antibiotic therapy according to current guidelines ( control group ) or with a PCT-pyuria-based algorithm ( PCT-pyuria group ) .


The primary endpoint was overall antibiotic exposure within 90 days .


Secondary endpoints included duration of the initial antibiotic therapy , persistent infection 7 days after end of therapy and 30 days after enrollment , recurrence and rehospitalizations within 90 days .


Overall , 394 patients were screened , 228 met predefined exclusion criteria , 30 declined to participate , and 11 were not eligible .


Of these , 125 ( 76 % women ) were enrolled in the intention-to-treat ( ITT ) analysis and 96 patients with microbiologically confirmed UTI constituted the per protocol group ; 84 of 125 ( 67 % ) patients had a febrile UTI , 28 ( 22 % ) had bacteremia , 5 ( 4 % ) died , and 3 ( 2 % ) were lost to follow-up .


Overall antibiotic exposure within 90 days was shorter in the PCT-pyuria group than in the control group ( median 7.0 [ IQR , 5.0-14 .0 ] vs. 10.0 [ IQR , 7.0-16 .0 ] days , P = 0.011 ) in the ITT analysis .


Mortality , rates of persistent infections , recurrences , and rehospitalizations were not different .


A PCT-pyuria-based algorithm reduced antibiotic exposure by 30 % when compared to current guidelines without apparent negative effects on clinical outcomes .


Patients with relapsed chronic lymphocytic leukemia ( CLL ) who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy .


Effective therapies with acceptable side-effect profiles are needed for this patient population .


In this multicenter , randomized , double-blind , placebo-controlled , phase 3 study , we assessed the efficacy and safety of idelalisib , an oral inhibitor of the delta isoform of phosphatidylinositol 3-kinase , in combination with rituximab versus rituximab plus placebo .


We randomly assigned 220 patients with decreased renal function , previous therapy-induced myelosuppression , or major coexisting illnesses to receive rituximab and either idelalisib ( at a dose of 150 mg ) or placebo twice daily .


The primary end point was progression-free survival .


At the first prespecified interim analysis , the study was stopped early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy .


The median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group ( hazard ratio for progression or death in the idelalisib group , 0.15 ; P < 0.001 ) .


Patients receiving idelalisib versus those receiving placebo had improved rates of overall response ( 81 % vs. 13 % ; odds ratio , 29.92 ; P < 0.001 ) and overall survival at 12 months ( 92 % vs. 80 % ; hazard ratio for death , 0.28 ; P = 0.02 ) .


Serious adverse events occurred in 40 % of the patients receiving idelalisib and rituximab and in 35 % of those receiving placebo and rituximab .


The combination of idelalisib and rituximab , as compared with placebo and rituximab , significantly improved progression-free survival , response rate , and overall survival among patients with relapsed CLL who were less able to undergo chemotherapy .


( Funded by Gilead ; ClinicalTrials.gov number , NCT01539512 . )


We characterized the incidence of central nervous system ( CNS ) metastases after treatment with trastuzumab emtansine ( T-DM1 ) versus capecitabine-lapatinib ( XL ) , and treatment efficacy among patients with pre-existing CNS metastases in the phase III EMILIA study .


In EMILIA , patients with human epidermal growth factor receptor 2 ( HER2 ) - positive advanced breast cancer previously treated with trastuzumab and a taxane were randomized to T-DM1 or XL until disease progression .


Patients with treated , asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases were identified retrospectively by independent review ; exploratory analyses were carried out .


Among 991 randomized patients ( T-DM1 = 495 ; XL = 496 ) , 95 ( T-DM1 = 45 ; XL = 50 ) had CNS metastases at baseline .


CNS progression occurred in 9 of 450 ( 2.0 % ) and 3 of 446 ( 0.7 % ) patients without CNS metastases at baseline in the T-DM1 and XL arms , respectively , and in 10 of 45 ( 22.2 % ) and 8 of 50 ( 16.0 % ) patients with CNS metastases at baseline .


Among patients with CNS metastases at baseline , a significant improvement in overall survival ( OS ) was observed in the T-DM1 arm compared with the XL arm [ hazard ratio ( HR ) = 0.38 ; P = 0.008 ; median , 26.8 versus 12.9 months ] .


Progression-free survival by independent review was similar in the two treatment arms ( HR = 1.00 ; P = 1.000 ; median , 5.9 versus 5.7 months ) .


Multivariate analyses demonstrated similar results .


Grade 3 adverse events were reported in 48.8 % and 63.3 % of patients with CNS metastases at baseline administered T-DM1 and XL , respectively ; no new safety signals were observed .


In this retrospective , exploratory analysis , the rate of CNS progression in patients with HER2-positive advanced breast cancer was similar for T-DM1 and for XL , and higher overall in patients with CNS metastases at baseline compared with those without CNS metastases at baseline .


In patients with treated , asymptomatic CNS metastases at baseline , T-DM1 was associated with significantly improved OS compared with XL .


to analyze the morphological structure of cardiac , blood pressure ( BP ) , heart rate ( HR ) and heart rate variability ( HRV ) of rats subjected to physical training with supplementation of caffeine .


60 rats were divided into 4 groups : control ( CO ) , control with caffeine ( CAF ) , trained control ( TRE ) and trained with caffeine ( TCAF ) .


All trained groups underwent 4 weeks of swimming , and all caffeine groups were supplemented by voluntary ingestion of caffeine diluted in drinking water .


there were no changes to BP and HR between groups .


Regarding HRV , there was a decrease in LFnorm ( low frequency ) and LF/HF ratio ( low and high frequency ) in TCAF and CAF compared to group ( p < 0.02 and p < 0.03 , respectively ) .


An increase occurred in CAF compared to the CO in the component LFnorm ( p < 0.05 ) .


The results also showed an increase in the relative weight of heart in the TRE ( p < 0.04 ) and TCAF ( p < 0.03 ) compared to CO. .


caffeine did not modify the hemodynamic responses .


However , physical training resulted in a decrease in sympathetic response and an increase in relative heart weight .


Mexico 's sugar-sweetened beverage ( SSB ) intake is among the highest globally .


Although evidence shows that increases in SSB intake are linked with increased energy intake , weight gain , and cardiometabolic risks , few randomized clinical trials have been conducted in adults .


The aim of this study was to determine if replacing SSBs with water affects plasma triglycerides ( TGs ) ( primary outcome ) , weight , and other cardiometabolic factors .


We selected overweight/obese ( BMI 25 and < 39 kg/m ( 2 ) ) women ( 18-45 y old ) reporting an SSB intake of at least 250 kcal/d living in Cuernavaca , Mexico .


Women were randomly allocated to the water and education provision ( WEP ) group ( n = 120 ) or the education provision ( EP ) - only group ( n = 120 ) .


The WEP group received biweekly water deliveries , and both groups received equal monthly nutrition counseling .