To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention ( LISS-DP ) , as a clinically feasible strategy for primary prevention , on diet and physical activity habits in adults with a family history of type 2 diabetes .


This was a two-arm , randomized controlled trial : ( 1 ) lifestyle intervention ( LI ) group ( n = 70 ) ; ( 2 ) control ( n = 71 ) .


Healthy adults aged 30-60 years with a history of type 2 diabetes among their first-degree relatives were recruited .


LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail .


Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline , compared to control ( -118.31 and -24.79 kcal/day , respectively , p = 0.0099 , Cohen 's d = 0.22 ) , though the difference disappeared 1 year after from baseline .


No difference was found in physical activity energy expenditure .


A computer-based , non-face-to-face lifestyle intervention was effective on dietary habits , only during the intervention period .


Further examination of the long-term effects of such intervention and physical activity is required .


The present study aimed to compare the postoperative contrast sensitivity functions between wavefront-guided LASIK eyes and their contralateral wavefront-guided PRK eyes .


The participants were 11 healthy subjects ( mean age = 32.4 6.2 years ) who had myopic astigmatism .


The spatial contrast sensitivity functions were measured before and three times after the surgery .


Psycho and a Cambridge graphic board ( VSG 2/4 ) were used to measure luminance , red-green , and blue-yellow spatial contrast sensitivity functions ( from 0.85 to 13.1 cycles/degree ) .


Longitudinal analysis and comparison between surgeries were performed .


There was no significant contrast sensitivity change during the one-year follow-up measurements neither for LASIK nor for PRK eyes .


The comparison between procedures showed no differences at 12 months postoperative .


The present data showed similar contrast sensitivities during one-year follow-up of wave-front guided refractive surgeries .


Moreover , one year postoperative data showed no differences in the effects of either wavefront-guided LASIK or wavefront-guided PRK on the luminance and chromatic spatial contrast sensitivity functions .


Survivors of cervical cancer experience quality-of-life ( QOL ) disruptions that persist years after treatment .


This study examines the effect of a psychosocial telephone counseling ( PTC ) intervention on QOL domains and associations with biomarkers .


We conducted a randomized clinical trial in survivors of cervical cancer , who were 9 and less than 30 months from diagnosis ( n = 204 ) , to compare PTC to usual care ( UC ) .


PTC included five weekly sessions and a 1-month booster .


Patient-reported outcomes ( PROs ) and biospecimens were collected at baseline and 4 and 9 months after enrollment .


Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures .


Participant mean age was 43 years ; 40 % of women were Hispanic , and 51 % were non-Hispanic white .


Adjusting for age and baseline scores , participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants ( all P < .05 ) ; significant differences in gynecologic and cancer-specific concerns ( P < .05 ) were sustained at 9 months .


Longitudinal change in overall QOL and anxiety did not reach statistical significance .


Participants with decreasing interleukin ( IL ) -4 , IL-5 , IL-10 , and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels .


This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer .


The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship .


There is a paucity of data on the effect of antiretroviral medications on male fertility .


Couples affected by HIV-1 often have fertility intentions , and antiretroviral medications , as both treatment of HIV-1-infected persons and pre-exposure prophylaxis ( PrEP ) for uninfected persons , are part of peri-conception risk reduction .


Within a randomized , placebo-controlled trial of daily oral tenofovir disoproxil fumarate ( TDF ) and combination emtricitabine ( FTC ) / TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples , we assessed the impact of TDF and FTC/TDF use on male fertility , measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo .


Of the 2962 HIV-1-uninfected men partners , 986 were randomized to TDF , 1013 to FTC/TDF , and 963 to placebo .


The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms ( 13.2 TDF , 12.4 FTC/TDF , 13.2 placebo ) .


The frequency of live births , pregnancy losses , and gestational age at birth or loss was also statistically similar in the three randomization groups .


TDF and FTC/TDF , when used as PrEP by HIV-1-uninfected men , did not adversely affect male fertility or pregnancy outcomes .


Tiotropium is a once-daily , long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis .


Our objective was to evaluate the efficacy and safety of 2.5 and 5 g once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis .


This phase 2 , 12-week , randomized , double-blind , placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second ( FEV1 ) 25 % predicted .


Co-primary efficacy end points were change from baseline in percent-predicted FEV1 area under the curve from 0 to 4 hours ( FEV1 AUC0-4h ) , and trough FEV1 at the end of week 12 .


A total of 510 subjects with cystic fibrosis aged 5-69 years were randomized .


Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 ( change from baseline in percent-predicted FEV1 AUC0-4h : 2.5 g : 2.94 % , 95 % confidence interval 1.19-4 .70 , p = 0.001 ; 5 g : 3.39 % , 95 % confidence interval 1.67-5 .12 , p = 0.0001 ; in percent-predicted trough FEV1 2.5 g : 2.24 % , p = 0.2 ; 5 g : 2.22 % , p = 0.02 ) .


There was a greater benefit with tiotropium 5 vs. 2.5 g. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium .


Tiotropium significantly improved lung function in people with cystic fibrosis .


The improvement was greater with the higher dose than the lower dose , with no difference in adverse events .


ClinicalTrials.gov NCT00737100 EudraCT 2008-001156-43 .


Obstructive sleep apnea is associated with hypertension , inflammation , and increased cardiovascular risk .


Continuous positive airway pressure ( CPAP ) reduces blood pressure , but adherence is often suboptimal , and the benefit beyond management of conventional risk factors is uncertain .


Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea , we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk .


We conducted a randomized , controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices .


Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire , and home sleep testing was used to establish the diagnosis .


Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone ( the control group ) or , in addition to education , either CPAP or nocturnal supplemental oxygen .


Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment .


The primary outcome was 24-hour mean arterial pressure .


Of 318 patients who underwent randomization , 281 ( 88 % ) could be evaluated for ambulatory blood pressure at both baseline and follow-up .


On average , the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group ( -2.4 mm Hg ; 95 % confidence interval [ CI ] , -4.7 to -0.1 ; P = 0.04 ) or the group receiving supplemental oxygen ( -2.8 mm Hg ; 95 % CI , -5.1 to -0.5 ; P = 0.02 ) .


There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen .


A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis .


In patients with cardiovascular disease or multiple cardiovascular risk factors , the treatment of obstructive sleep apnea with CPAP , but not nocturnal supplemental oxygen , resulted in a significant reduction in blood pressure .


( Funded by the National Heart , Lung , and Blood Institute and others ; HeartBEAT ClinicalTrials.gov number , NCT01086800 . )


Oxidative stress and inflammation during cardiac surgery may be associated with acute renal injury ( ARI ) .


N-acetyl cysteine ( NAC ) and carvedilol have antioxidant and anti-inflammatory properties .


A combination of carvedilol and NAC should decrease the incidence of ARI more than metoprolol or carvedilol .


Patients undergoing cardiac surgery were randomized to metoprolol , carvedilol , or carvedilol plus NAC .


End points were occurrence of ARI and change in preoperative to postoperative peak creatinine levels .


ARI incidence was lower in the carvedilol plus NAC group compared with the metoprolol ( 21.0 % vs 42.1 % ; P = 0.002 ) or carvedilol ( 21.0 % vs 38.6 % ; P = 0.006 ) groups , but was similar between the metoprolol and carvedilol groups ( P = 0.62 ) .


Preoperative and postoperative day 1 creatinine levels were similar among the metoprolol ( 1.02 [ 0.9-1 .2 ] and 1.2 [ 0.92-1 .45 ] ) the carvedilol ( 1.0 [ 0.88-1 .08 ] and 1.2 [ 0.9-1 .5 ] ) and the carvedilol plus NAC groups ( 1.06 [ 0.9-1 .18 ] and 1.1 [ 1.0-1 .21 ] mg/dL ; all P values > 0.05 ) .


Postoperative day 3 , day 5 , and peak creatinine levels were lower in the carvedilol plus NAC group ( 1.11 [ 1.0-1 .23 ] , 1.14 [ 1.0-1 .25 ] and 1.15 [ 1.0-1 .25 ] ) as compared with the metoprolol ( 1.4 [ 1.3-1 .49 ] , 1.3 [ 1.0-1 .54 ] and 1.3 [ 1.0-1 .54 ] ) or carvedilol groups ( 1.2 [ 1.0-1 .52 ] , 1.25 [ 1.0-1 .52 ] and 1.25 [ 1.0-1 .55 ] mg/dL ; all P values < 0.05 ) , but were similar between the metoprolol and carvedilol groups ( all P values > 0.05 ) .


Combined carvedilol and NAC decreased ARI incidence as compared with carvedilol or metoprolol .


No difference was detected between carvedilol and metoprolol .


Ticagrelor has been shown to improve outcomes in patients with ACS .


However , the effects of this drug on parameters of microvascular flow in patients presenting with ST-segment elevation myocardial infarction ( STEMI ) have not been completely evaluated .


Ninety-two patients presenting with STEMI where randomized to a loading dose of clopidogrel ( 600 mg ) or ticagrelor ( 180 mg ) before undergoing primary angioplasty .


We assessed angiographic and electrocardiographic parameters of myocardial reperfusion .


Blinded operators calculated angiographic corrected TIMI Frame count ( cTFC ) and myocardial blush grade ( MBG ) before and after stent implantation .


ST segment resolution was also measured in all patients .


Primary endpoint was cTFC after PCI .


Secondary endpoints were cTFC prior to PCI , TIMI flow grade , MBG and the percentage of ST resolution .


Of the 92 randomized patients , 70 patients were analyzed .


Mean age of patients was 58.810 years .


Patients presented with a mean ischemic time of 4.42.6 hours .


There were no significant differences in the time between loading dose and stent deployment ( 35.236.4 in ticagrelor and 42.729.5 min in clopidogrel , p = 0.36 ) .


cTFC before angioplasty was significantly lower in ticagrelor than in clopidogrel ( 81.129.4 vs. 95.117.5 frames respectively , p = 0.01 ) .


After angioplasty there were no differences between ticagrelor and clopidogrel in cTFC ( 24.69.3 vs. 27.013.4 frames respectively , p = 0.62 ) ; MBG grade 3 was present in 76.4 vs. 69.4 % of patients , respectively ( p = 0.41 ) .


The percentage of ST resolution did not show any differences between groups ( 84.823.4 in ticagrelor vs. 70.833.7 in clopidogrel , p = 0.36 ) .


Compared with clopidogrel , ticagrelor loading in patients presenting with STEMI is not associated with an improvement of angiographic and electrocardiographic parameters of myocardial reperfusion after angioplasty .


Povidone iodine is used primarily as an antiseptic to decrease surgical site infection .


Its hemostatic and antiedematous properties in oral surgery also have been investigated recently .


A randomized controlled clinical trial was performed in 30 patients undergoing mandibular third molar removal in a split-mouth design .


In the study group , a povidone iodine solution with a concentration of 0.5 mg/mL was used as the coolant and irrigant solution , whereas normal saline was used in the control group .


Swelling ( orotragus and mentotragus distances ) , trismus ( maximum interincisal opening ) , and pain ( visual analog scale score ) were evaluated on postoperative days 2 and 7 .


In the study group , a significant decrease in swelling and trismus was observed at the 2 postoperative visits ( P = .00 ) compared with the control group .


The decrease of pain in the study group was not statistically significant at either postoperative visit ( P > .05 ) .


More patients ( 63 % ) were subjectively satisfied with the side treated with povidone iodine .


Povidone iodine irrigation is an inexpensive and safe method to lessen the postoperative sequelae of third molar surgery .


Pertuzumab plus trastuzumab provides a more comprehensive blockade of HER2 signalling than trastuzumab alone .


Therefore , we conducted a phase IIa study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer ( aGC ) .


Patients received pertuzumab 840 mg for cycle 1 and 420 mg q3w for cycles 2-6 ( Arm A ) or pertuzumab 840 mg q3w for six cycles ( Arm B ) .


Trastuzumab , cisplatin and capecitabine were also given for six cycles , then trastuzumab q3w until disease progression or unmanageable toxicity .


The co-primary endpoints were day 43 pertuzumab serum trough concentration ( Cmin ) and safety .


Thirty patients were randomised .


Mean pertuzumab Cmin at day 43 was 40.0 g ml ( -1 ) ( s.d. : 17.3 ) in Arm A and 62.7 g ml ( -1 ) ( 29.1 ) in Arm B. Mean day 43 Cmin in Arm A was ~ 37 % lower than that seen in metastatic breast cancer .


The safety profiles were similar between arms and treatment was well tolerated .


Partial responses were achieved by 86 % and 55 % of patients in Arms A and B , respectively .


On the basis of the pharmacokinetic and safety data , the 840 mg q3w pertuzumab dose has been selected for a phase III study of pertuzumab , trastuzumab and chemotherapy in HER2-positive aGC .


There are significant health disparities between Mori and non-Mori with asthma , a pattern seen between other ethnic populations .


This study investigates outcomes for Mori in a randomized controlled trial ( RCT ) of combination budesonide/formoterol inhaler therapy in asthma .


This 24-week multicentre RCT recruited 303 adult asthma patients , 44 of whom were Mori .


Participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ( ` SMART ' ) regimen or ` standard ' regimen ( combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever ) .


Outcomes included patterns of beta-agonist inhaler use including ` high use ' of reliever therapy ( > 8 actuations of budesonide/formoterol in excess of four maintenance doses per day for SMART and > 16 actuations per day of salbutamol for standard ) .


Differences in outcomes for Mori versus non-Mori were assessed using an interaction term between ethnicity and treatment .


With adjustment for ethnicity , the SMART group had fewer days of high use ( relative rate ( RR ) 0.57 ( 95 % confidence interval ( CI ) : 0.38-0 .85 ) ) , days of high use without medical review within 48 h ( RR 0.49 ( 95 % CI : 0.32-0 .75 ) ) and severe exacerbations ( RR 0.54 ( 95 % CI : 0.36-0 .81 ) ) compared with standard .


The magnitude of the benefit from the SMART regimen was similar in Mori and non-Mori .


Regardless of treatment regimen , Mori demonstrated more days of high use , high use without medical review and underuse of maintenance therapy .


The SMART regimen has a favourable risk/benefit profile in Mori .


Days of high use , days of high use without medical review and underuse of maintenance treatment were greater in Mori , regardless of treatment regimen .


Early infant male circumcision ( EIMC ) is a potential key HIV prevention intervention , providing it can be safely and efficiently implemented in sub-Saharan Africa .


Here , we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe .


Between January and June 2013 , eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor , using a 2:1 allocation ratio .


Participants were followed for 14 days post-EIMC .


Primary outcomes for the trial were EIMC safety and acceptability .


One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum ( n = 100 AccuCirc ; n = 50 Mogen clamp ) .


Twenty-six infants ( 17 % ) were born to HIV-infected mothers .


We observed 2 moderate adverse events ( AEs ) [ 2 % , 95 % confidence interval ( CI ) : 0.2 to 7.0 ] in the AccuCirc arm and none ( 95 % CI : 0.0 to 7.1 ) in the Mogen clamp arm .


The cumulative incident risk of AEs was 2.0 % higher in the AccuCirc arm compared with the Mogen Clamp arm ( 95 % CI : -0.7 to 4.7 ) .


As the 95 % CI excludes the predefined noninferiority margin of 6 % , the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp .


Nearly all mothers ( 99.5 % ) reported great satisfaction with the outcome .


All mothers , regardless of arm said they would recommend EIMC to other parents , and would circumcise their next son .


This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents .


There was no difference in the rate of AEs by device .


This randomized , cross-over trial was designed to investigate the metabolic and appetitive responses to skipping breakfast in overweight women who were habitual breakfast Eaters or Skippers .


Nine Eaters and nine Skippers were studied on two separate days during which subjects ate breakfast ( B ) or had no breakfast ( NB ) , followed by a standard lunch meal 4 h later .


Blood sampling for hormones and metabolites was performed after lunch , and appetite was rated throughout the day .


Interactions between day and habitual breakfast pattern were seen for area under the curve ( AUC ) for insulin and free fatty acids ( FFA ) .


Both insulin ( P = 0.020 ) and FFA ( P = 0.023 ) AUC were higher on the NB day for Eaters but similar on both days for Skippers .


Eaters had higher pre lunch hunger AUC on the NB day ( P = 0.015 ) as well as lower pre lunch satiety AUC under both conditions ( P = 0.019 ) .


Overall , this study showed that the adverse effects of skipping breakfast ( higher insulin and FFA responses to lunch , increased hunger , and decreased satiety ) were found primarily in habitual breakfast eaters .


This suggests that meal skipping may have enhanced effects in habitual Eaters due to entrainment of metabolic and appetitive regulatory systems .


The aim of this study was to compare the combined ultrasound-guided supraclavicular brachial plexus block ( SCB ) and distal median , radial , and ulnar nerve blocks , with the supraclavicular block alone .


Sixty-two patients undergoing upper extremity surgery were randomized to supraclavicular only ( Group S , n = 31 ) or supraclavicular + distal ( Group SD , n = 31 ) group .


Patients in Group S received 32mL of 1.5 % lidocaine + epinephrine 5g/mL , while those in Group SD received 20mL of 1.5 % lidocaine + epinephrine 5g/mL followed by distal median , radial , and ulnar nerve blocks using equal volumes of 2 % lidocaine +0.5 % levobupivacaine ( 4mL/nerve ) .


Sensory and motor blocks of the ulnar , median , radial and musculocutaneous nerves were assessed every 5min starting at the 10th minute .


The imaging , needling and performance times were recorded .


Also , the onset and anesthesia-related times , need for analgesic and first analgesic times , were noted .


In Group SD , the anesthesia onset [ 15 ( 10-25 ) vs. 20 ( 15-30 ) min , p < 0.001 ] and anesthesia related times [ 16.6 ( 10.7-28 .2 ) vs. 22 ( 15.9-33 .7 ) min , p < 0.001 ] were significantly shorter than those of Group S. Additionally , the analgesic requirement was lower in Group SD ( 56.7 vs. 88.5 % , p = 0.009 ) , while among the patients who required analgesic , the first analgesic time was longer in Group SD in comparison to Group S [ 625 ( 347-1764 ) vs. 315 ( 233-746 ) min p < 0.001 ] .


The addition of distal median , radial , and ulnar nerve blocks to SCB shortens anesthesia-related time and anesthesia onset time when compared with a SCB alone .


Patients suffering from mild-to-moderate medial compartment knee osteoarthritis may be treated with an unloader knee orthosis .


However , compliance has been shown to be an issue with such devices .


The aim of this study was to identify the effects of a new design of knee unloader orthosis on specific gait parameters in patients with mild-to-moderate medial knee osteoarthritis .


The gait of seven patients was assessed in two conditions : without an orthosis and when wearing a new design of unloader knee orthosis .


Gait analysis was performed to determine alterations to the adduction moment , speed of walking , step length , cadence and knee sagittal plane range of motion during ambulation for the two test conditions .


The knee adduction moment was significantly reduced ( p = 0.001 ) , and the speed of walking significantly increased ( p < 0.001 ) when wearing the orthosis .


However , a reduction in knee range of motion ( p = 0.002 ) and an increase in step length ( p < 0.001 ) were observed with the orthosis donned .


Cadence was not significantly altered ( p = 0.504 ) .


The use of a new design of unloader knee orthosis as a conservative treatment approach for patients with mild-to-moderate medial compartment osteoarthritis appears warranted .


Various conservative modalities have been used to reduce pain and improve function in medial compartment osteoarthritis .


A new design of an unloader knee orthosis has been developed and is shown to have immediate benefits in patients with mild medial knee osteoarthritis .


To determine the effects of a small-dose ketamine-propofol combination used for sedation during spinal anesthesia on tourniquet-induced ischemia-reperfusion injury .


Prospective randomized study .


Training and research hospital .


60 adult , ASA physical status 1 and 2 patients , ages 20-60 years , scheduled for elective arthroscopic knee surgery for meniscal and chondral lesions .


The initial hemodynamic parameters were recorded and blood samples were collected at baseline ( T1 ) ; then spinal anesthesia was performed .


In Group I ( n = 30 ) , a combination of 0.5 mg/kg/hr of ketamine and 2 mg/kg/hr of propofol was administered ; Group II ( n = 30 ) received an equivalent volume of saline as an infusion .


A pneumatic tourniquet was applied .


Malondialdehyde ( MDA ) , superoxide dismutase ( SOD ) , and catalase levels were measured one minute before tournique deflation in the ischemic period ( T2 ) , then 5 ( T3 ) and 30 ( T4 ) minutes following tourniquet deflation in the reperfusion period .


No differences were noted between groups in hemodynamic data ( P > 0.05 ) or SOD levels ( P > 0.05 ) .


In Group I , MDA levels at T2 were lower than in Group II ( P < 0.05 ) .


In Group I , catalase levels were lower at T2 and T4 than they were in Group II ( P < 0.05 ) .


Small-dose ketamine-propofol combination may be useful in reducing tourniquet-induced ischemia-reperfusion injury in arthroscopic knee surgery .


Black men exhibit a high prevalence of vitamin D deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than Whites .


There are few data about the effect of vitamin D3 ( cholecalciferol ) supplementation on prostate-specific antigen ( PSA ) in healthy Black men .


During three winters from 2007 to 2010 , 105 Black men ( median age , 48.9 years ) of Boston , MA were randomized into a four-arm , double-blind trial for 3 months of placebo , 1,000 , 2,000 , or 4,000 U of vitamin D3 .


At baseline and 3 months , free and total PSA was measured .


With vitamin D supplementation , no significant differences in free and total PSA were observed ; free PSA , -0.0004 ng/mL ( P = 0.94 ) and total PSA , -0.004 ng/mL ( P = 0.92 ) for each additional 1,000 U/d of vitamin D3 .


Within an unselected population of healthy Black men without a cancer diagnosis , we found no effect of vitamin D supplementation on free or total PSA .


These findings support prior findings of no change in PSA with vitamin D supplementation and emphasize the need for new methods to assess the influence of vitamin D supplementation on prostate cancer prevention .


Treating schizophrenia patients who fail to respond to antipsychotics is a major challenge , and the percentage of treatment-resistant patients is estimated to be 20-25 % .


Recent studies indicate that yokukansan ( YKS ; D2 and 5HT1A partial agonist and 5HT2A and glutamate antagonist ) to be safe and useful in treating behavioral and psychological symptoms associated with dementia and other neuropsychiatric conditions .


We aimed at evaluating both the efficacy and safety of YKS in patients with treatment-resistant schizophrenia .


This randomized , multicenter , double-blind , placebo-controlled study was conducted between May 2010 and August 2012 .


One hundred twenty antipsychotic-treated inpatients from 34 psychiatric hospitals in Japan were included .


Patients were randomized to adjuvant treatment with YKS 7.5 g/day or placebo .


During a 4-week follow-up , psychopathology was assessed using the Positive and Negative Syndrome Scale ( PANSS ) with five factors [ excitement/hostility ( P4 , P7 , G8 , and G14 ) , depression/anxiety ( G1 , G2 , G3 , G4 , and G6 ) , cognition ( P2 , N5 , N7 , G5 , G10 , G11 , G12 , G13 , and G15 ] , positive ( P1 , P3 , P5 , P6 , and G9 ) , and negative ( N1 , N2 , N3 , N4 , N6 , G7 , and G16 ] ] .


Other assessments included , Clinical Global Impression-Severity ( CGI-S ) , Global Assessment of Functioning ( GAF ) , and Drug-Induced Extrapyramidal Symptoms Scale ( DIEPSS ) .


The primary efficacy outcome was the change in PANSS five-factor scores .


The secondary outcomes were changes in the scores of CGI-S .


The analysis was made on a modified intention to treat basis with the help of a last observation carried forward method .


YKS showed a tendency of superiority to placebo in reducing total all PANSS five-factor scores in treatment-resistant schizophrenia , but the difference was not statistically significant in total , depression/anxiety , cognition , positive , and negative factors .


However , compared to the placebo group , the YKS group showed statistically significant improvements in the PANSS excitement/hostility factor scores ( p < 0.05 ) .


No substantial side effects were recorded .


The results of the present study indicate YKS to be a potential adjunctive treatment strategy for treatment-resistant schizophrenia , particularly to improve excitement/hostility symptoms .


To evaluate the therapeutic effect on pain in the dressing change after perianal abscess surgery treated with warm suspending moxibustion at Changqiang ( GV 1 ) .


One hundred and sixty patients were randomized into a moxibustion group and a far-infrared therapy group , 80 cases in each one .


In the moxibustion group , the warm suspending moxibustion at Changqiang ( GV 1 ) was applied .


In the far-infrared therapy group , the infrared ray was radiated at Changqiang ( GV 1 ) .


The treatment started in 10 min after dressing change in the two groups .


Totally , 8 treatments were required .


The time requirement being equal to or less than 2 score in the assessment face scale ( AFS ) , the case number of pain relief in 10 min after treatment and the intention of the two therapies after everyday dressing change were observed in the patients of the two groups .


In the moxibustion group , the time of pain relief was shorter than that of the far-infrared therapy group [ ( 11.5 + / - 3.9 ) min vs ( 17.8 + / - 3.8 ) min on the 1st day ; ( 9.4 + / - 3.6 ) min vs ( 15.2 + / - 4.3 ) min on the 2nd day ; ( 7.8 + / - 2.7 ) min vs ( 14.3 + / - 3.2 ) min on the 3rd day ; ( 6.4 + / - 3.3 ) min vs ( 10.5 + / - 2.9 ) min on the 4th day ; ( 5.9 + / - 2.9 ) min vs ( 11.2 + / - 1.9 ) min on the 5th day ; ( 5.3 + / - 2.2 ) min vs ( 8.8 + / - 2.3 ) min on the 6th day ; ( 5.4 + / - 1.8 ) min vs ( 9.2 + / - 2.1 ) min on the 7th day ; ( 5.1 + / - 1.4 ) min vs ( 9.5 + / - 2.6 ) min on the 8th day , all P < 0.05 ] .


The case numbers of pain relief in 10 min after treatment were 74 cases , 75 cases , 77 cases and 78 cases from the 1st to the 4th day separately in the moxibustion group , which were much more than 63 cases , 65 cases , 68 cases and 69 cases in the far-infrared therapy group ( all P < 0.05 ) .


The treatment intention scores in the moxibustion group were better than those in the far-infrared therapy group ( all P < 0.05 ) .


The warm suspending moxibustion at Changqiang ( GV 1 ) relieves pain rapidly in the dressing change of much more patients after perianal abscess surgery in much shorter time as compared with the far-infrared therapy .


Moreover , the patients have more expectation to be treated with moxibustion therapy .


To prospectively assess the antiinflammatory effect of volatile anesthetic sevoflurane in patients undergoing open lung surgery with one lung ventilation ( OLV ) .


This prospective , randomized study included 40 patients undergoing thoracic surgery with OLV ( NCT02188407 ) .


The patients were randomly allocated into two equal groups that received either propofol or sevoflurane .


Four patients were excluded from the study because after surgery they received blood transfusion or non-steroid antiinflammatory drugs .


Inflammatory mediators ( interleukins 6 , 8 , and 10 , C-reactive protein [ CRP ] , and procalcitonin ) were measured perioperatively .


The infiltration of the nonoperated lung was assessed on chest x-rays and the oxygenation index was calculated .


The major postoperative complications were counted .


Interleukin 6 levels were significantly higher in propofol than in sevoflurane group ( P = 0.014 ) .


Preoperative CRP levels did not differ between the groups ( P = 0.351 ) and in all patients they were lower than 20 mg/L , but postoperative CRP was significantly higher in propofol group ( 316 vs 157 ng/L ; P = 0.035 ) ; Pre - and postoperative procalcitonin was within the reference range ( < 0.04 g/L ) in both groups .


The oxygenation index was significantly lower in propofol group ( 339139 vs 465140 ; P = 0.021 ) .


There was no significant difference between the groups in lung infiltrates ( P = 0.5849 ) .


The number of postoperative adverse events was higher in propofol group , but the difference was not-significant ( 5 vs 1 ; P = 0.115 ) .


The study suggests an antiinflammatory effect of sevoflurane in patients undergoing thoracotomy with OLV .


There is a paucity of controlled treatment trials for the treatment of conversion disorder , seizures type , also known as psychogenic nonepileptic seizures ( PNES ) .


Psychogenic nonepileptic seizures , the most common conversion disorder , are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians .


To evaluate different PNES treatments compared with standard medical care ( treatment as usual ) .


Pilot randomized clinical trial at 3 academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with PNES .


Thirty-eight participants were randomized in a blocked schedule among 3 sites to 1 of 4 treatment arms and were followed up for 16 weeks between September 2008 and February 2012 ; 34 were included in the analysis .


Medication ( flexible-dose sertraline hydrochloride ) only , cognitive behavioral therapy informed psychotherapy ( CBT-ip ) only , CBT-ip with medication ( sertraline ) , or treatment as usual .


Seizure frequency was the primary outcome ; psychosocial and functioning measures , including psychiatric symptoms , social interactions , quality of life , and global functioning , were secondary outcomes .


Data were collected prospectively , weekly , and with baseline , week 2 , midpoint ( week 8 ) , and exit ( week 16 ) batteries .


Within-group analyses for each arm were performed on primary ( seizure frequency ) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis .


The psychotherapy ( CBT-ip ) arm showed a 51.4 % seizure reduction ( P = .01 ) and significant improvement from baseline in secondary measures including depression , anxiety , quality of life , and global functioning ( P < .001 ) .


The combined arm ( CBT-ip with sertraline ) showed 59.3 % seizure reduction ( P = .008 ) and significant improvements in some secondary measures , including global functioning ( P = .007 ) .


The sertraline-only arm did not show a reduction in seizures ( P = .08 ) .


The treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures ( P = .19 ) .


This pilot randomized clinical trial for PNES revealed significant seizure reduction and improved comorbid symptoms and global functioning with CBT-ip for PNES without and with sertraline .


There were no improvements in the sertraline-only or treatment-as-usual arms .


This study supports the use of manualized psychotherapy for PNES and successful training of mental health clinicians in the treatment .


Future studies could assess larger-scale intervention dissemination .


clinicaltrials.gov Identifier : NCT00835627 .


This study compared the therapeutic effects of collateral meridian therapy ( CMT ) with traditional acupoint pressure therapy ( APT ) in patients with unilateral upper back pain .


Forty-nine patients with active myofascial trigger points in upper trapezius muscle were randomly allocated to the control ( CTL ) , APT , or CMT group .


Each subject in the CMT and APT groups received 2 sessions of treatment per week over 1 month .


Patients in the APT and CMT groups showed significant improvements 1 month after treatment in visual analogue scale , range of motion , pain pressure threshold , regional superficial blood flow , and physical health , as compared to the CTL group .


No significant differences in outcome measures were found between APT and CMT groups 1 month after treatment .


Both APT and CMT have comparable therapeutic efficacy in the treatment of unilateral upper back pain with active myofascial trigger points in the upper trapezius muscle .


It remains unknown whether local anaesthetic dose is the only factor influencing continuous popliteal-sciatic nerve block effects , or whether concentration , volume , or both exert an influence as well .


Bilateral sciatic catheters were inserted in volunteers ( n = 24 ) .


Catheters were randomly assigned to ropivacaine of either 0.1 % ( 8 ml h ( -1 ) ) or 0.4 % ( 2 ml h ( -1 ) ) for 6 h.


The primary endpoint was the tolerance to transcutaneous electrical stimulation within the tibial nerve distribution at hour 6 .


Secondary endpoints included current tolerance at other time points and plantar flexion maximum voluntary isometric contraction ( 22 h total ) .


At hour 6 , tolerance to cutaneous stimulation for limbs receiving 0.1 % ropivacaine was [ mean ( standard deviation ) ] 27.0 ( 20.2 ) vs26 .9 ( 20.4 ) mA for limbs receiving 0.4 % [ estimated mean difference 0.2 mA ; 90 % confidence interval ( CI ) -8.2 to 8.5 ; P = 0.02 and 0.03 for lower and upper boundaries , respectively ] .


Because the 90 % CI fell within the prespecified tolerance 10 mA , we conclude that the effect of the two concentration/volume combinations were equivalent .


Similar negative findings were found for the secondary outcomes .


For continuous popliteal-sciatic nerve blocks , we found no evidence that local anaesthetic concentration and volume influence block characteristics , suggesting that local anaesthetic dose ( mass ) is the primary determinant of perineural infusion effects in this anatomic location .


These findings suggest that for ambulatory perineural local anaesthetic infusion-for which there is usually a finite local anaesthetic reservoir-decreasing the basal rate while increasing the local anaesthetic concentration may allow for increased infusion duration without compromising postoperative analgesia .


NCT01898689 .


In VOICE , a multisite HIV pre-exposure prophylaxis ( PrEP ) trial , plasma drug levels pointed to widespread product nonuse , despite high adherence estimated by self-reports and clinic product counts .


Using a socio-ecological framework ( SEF ) , we explored socio-cultural and contextual factors that influenced participants ' experience of daily vaginal gel and oral tablet regimens in VOICE .


In Johannesburg , a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews ( n = 41 ) , serial ethnographic interviews ( n = 21 ) , or focus group discussions ( n = 40 ) .


Audiotaped interviews were transcribed , translated , and coded thematically for analysis .


Of the 102 participants , the mean age was 27 years , and 96 % had a primary sex partner with whom 43 % cohabitated .


Few women reported lasting nonuse , which they typically attributed to missed visits , lack of product replenishments , and family-related travel or work .


Women acknowledged occasionally skipping or mistiming doses because they forgot , were busy , felt lazy or bored , feared or experienced side effects .


However , nearly all knew or heard of other study participants who did not use products daily .


Three overarching themes emerged from further analyses : ambivalence toward research , preserving a healthy status , and managing social relationships .


These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products .


The unknown efficacy of products , their connection with HIV infection , challenges with daily regimen given social risks , lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use .


Personal acknowledgment of product nonuse was challenging .


This qualitative inquiry highlighted key influences at all SEF levels that shaped women 's perceptions of trial participation and experiences with investigational products .


Whether these impacted women 's behaviors and may have contributed to ineffective trial results warrants further investigation .


To improve the quality of eradication therapy ( ET ) , by increasing patient compliance .


An open-label cohort multicenter randomized study was conducted .


A total of 350 patients with Helicobacter pylori infection-associated diseases and indications for ET were examined .


Work was done to improve compliance in a study patient group before treatment .


In the study group of patients motivated for treatment , the efficiency of ET was significantly higher than in the control group .


The factors influencing treatment adherence were identified and methods to optimize compliance during H. pylori eradication were developed .


Awareness of the essence of the disease in a patient and his higher motivation for compliance are one of the components of successful H. pylori eradication .


Motor learning results in changes of movement representation in primary motor cortex ( M1 ) a process involving long-term potentiation ( LTP ) .


Pairing motor training with repetitive transcranial magnetic stimulation ( rTMS ) of M1 enhances the formation of a motor memory .


Here we determined the effect of pairing M1 stimulation and the execution of training movements at different times and frequencies on the formation of a motor memory .


Formation of a motor memory was defined as increases in motor evoked potentials ( MEP ) of the training agonist ( extensor carpi ulnaris muscle , ECU ) and increases in peak acceleration of the trained movements that last more than 60min .


Training consisted of auditory-paced ballistic wrist extension movements ( 30min , 0.5 Hz ) paired with 0.1 , 0.25 or 0.5 Hz subthreshold rTMS .


The rTMS pulse was applied at either the onset , 100ms prior to or 300ms after the onset of training movement related increases in electromyographic ( EMG ) activity of ECU .


This was compared to a Sham condition .


Only 0.1 Hz rTMS applied at the onset of the training related increase in ECU-EMG activity resulted in increases in MEP amplitudes and peak acceleration when compared to the Sham .


The formation of motor memory is enhanced above the nave level by co-administration of low frequency rTMS at the time of execution of training movements .


These results indicate the importance of time and frequency of rTMS in these settings and should be considered in the design of rehabilitation treatment strategies using rTMS .


Various devices have been developed to facilitate liver transection and reduce blood loss in liver resections .


None of these has proven superiority compared with the classical clamp-crushing technique .


This randomized clinical trial compared the effectiveness and safety of stapler transection with that of clamp-crushing during open liver resection .


Patients admitted for elective open liver resection between January 2010 and October 2011 were assigned randomly to stapler transection or the clamp-crushing technique .


The primary endpoint was the total amount of intraoperative blood loss .


Secondary endpoints included transection time , duration of operation , complication rates and resection margins .


A total of 130 patients were enrolled , 65 to clamp-crushing and 65 to stapler transection .


There was no difference between groups in total intraoperative blood loss : median ( i.q.r. ) 1050 ( 525-1650 ) versus 925 ( 450-1425 ) ml respectively ( P = 0279 ) .


The difference in total intraoperative blood loss normalized to the transection surface area was not statistically significant ( P = 0092 ) .


Blood loss during parenchymal transection was significantly lower in the stapler transection group ( P = 0002 ) , as were the parenchymal transection time ( mean ( s.d. ) 30 ( 21 ) versus 9 ( 7 ) min for clamp-crushing and stapler transection groups respectively ; P < 0001 ) and total duration of operation ( mean ( s.d. ) 221 ( 86 ) versus 190 ( 85 ) min ; P = 0047 ) .


There were no significant differences in postoperative morbidity ( P = 0863 ) or mortality ( P = 0684 ) between groups .


Stapler transection is a safe technique but does not reduce intraoperative blood loss in elective liver resection compared with the clamp-crushing technique .


NCT01049607 ( http://www.clinicaltrials.gov ) .


The effect of oral polio vaccine administered already at birth ( OPV0 ) on child survival was not examined before being recommended in 1985 .


Observational data suggested that OPV0 was harmful for boys , and trials have shown that neonatal vitamin A supplementation ( NVAS ) at birth may be beneficial for boys .


We set out to test this research question in a randomised trial .


The trial was carried out at the Bandim Health Project , Guinea-Bissau .


We planned to enrol 900 low-birth weight ( LBW ) boys in a randomised trial to investigate whether NVAS instead of OPV0 could lower infant mortality for LBW boys .


At birth , the children were randomised to OPV ( usual treatment ) or VAS ( intervention treatment ) and followed for 6 months for growth and 12 months for survival .


Hazard Ratios ( HR ) for mortality were calculated using Cox regression .


We compared the individual anthropometry measurements to the 2006 WHO growth reference .


We compared differences in z-scores by linear regression .


Relative risks ( RR ) of being stunted or underweight were calculated in Poisson regression models with robust standard errors .


In the rainy season we detected a cluster of deaths in the VAS group and the trial was halted immediately with 232 boys enrolled .


The VAS group had significantly higher mortality than the OPV0 group in the rainy season ( HR : 9.91 ( 1.23 - 80 ) ) .


All deaths had had contact with the neonatal nursery ; of seven VAS boys enrolled during one week in September , six died within two months of age , whereas only one died among the six boys receiving OPV ( p = 0.05 ) .


Growth ( weight and arm-circumference ) in the VAS group was significantly worse until age 3 months .


VAS at birth instead of OPV was not beneficial for the LBW boys in this study .


With the premature closure of the trial it was not possible to answer the research question .


However , the results of this study call for extra caution when testing the effect of NVAS in the future .


http://www.clinicaltrials.govNCT00625482 .


Registered 18 February 2008 .


Dual orexin receptor antagonists ( DORAs ) enable initiation and maintenance of sleep in patients with primary insomnia .


Blockade of the orexin system has shown reduction of drug-seeking behavior in animal studies , supporting the role of orexin antagonism as a novel approach for treating substance abuse .


Since hypnotics are traditionally associated with misuse , a lack of abuse liability of DORAs would offer significant benefits over current therapies for sleep disorders .


In this randomized , crossover , proof-of-concept study , single oral doses of the DORA almorexant ( 200 , 400 , and 1,000 mg ) were administered to healthy subjects with previous non-therapeutic experience with central nervous system depressants and were compared with placebo and single oral doses of zolpidem ( 20 and 40 mg ) , a benzodiazepine-like drug .


Subjective measures of abuse potential ( visual analog scales [ VAS ] , Addiction Research Center Inventory , and Subjective Drug Value ) and objective measures ( divided attention [ DA ] ) were evaluated over 24 h post-dose in 33 evaluable subjects .


Drug Liking VAS peak effect ( E max ; primary endpoint ) was significantly higher for all doses of almorexant and zolpidem compared with placebo ( p < 0.001 ) .


Almorexant 200 mg showed significantly less ` Drug Liking ' than both zolpidem doses ( p < 0.01 ) , and almorexant 400 mg had smaller effects than zolpidem 20 mg ( p < 0.05 ) , while almorexant 1,000 mg was not different from either zolpidem dose .


Results were similar for other subjective measures , although almorexant generally showed smaller negative and perceptual effects compared with zolpidem .


Almorexant also showed less cognitive impairment compared with zolpidem on most DA endpoints .


This study in humans investigating single doses of almorexant is the first to explore and show abuse liability of a DORA , a class of compounds that is not only promising for the treatment of sleep disorders , but also of addiction .


Music therapy is an innovative approach to support people with severe mental illness ( SMI ) .


The aim of the study was to determine whether group music therapy ( GMT ) positively impacted on quality of life ( QoL ) , social enrichment , self-esteem , spirituality and psychiatric symptoms of participants with SMI and how they experienced the intervention .


The primary outcome was QoL ; secondary measures assessed social enrichment , self-esteem , spirituality and psychiatric symptoms .


The 13-week intervention comprised singing familiar songs and composing original songs recorded in a professional studio .


Qualitative data were generated from focus group interviews and song lyric analysis .


Ninety-nine adults ( 57 female ) were recruited , with an initial cohort ( n = 75 ) randomized to either : weekly GMT followed by standard care ( SC ) or SC followed by GMT .


Crossover occurred after 13 weeks .


Measures were conducted at baseline , 13 , 26 and 39 weeks .


A second cohort ( n = 24 ) could not be randomized and were assigned to GMT followed by SC .


Intention-to-treat analysis showed a significant difference between GMT and SC on QoL and spirituality .


This was robust to different assumptions about missing data ( listwise deletion , last observation carried forward or multiple imputation ) .


Per-protocol analysis suggested greater benefit for those receiving more sessions .


Focus group interview and song lyric analyses suggested that GMT was enjoyable ; self-esteem was enhanced ; participants appreciated therapists and peers ; and although challenges were experienced , the programme was recommended to others .


Group music therapy may enhance QoL and spirituality of persons with SMI .


To test the application in practice of computerized fetal heart rate ( FHR ) analysis in pregnancy .


Randomized distribution of subjects with computerized analysis automatically revealed or concealed .


A district general hospital and a teaching hospital outside London .


2869 pregnant women studied within a year .


Quality and duration of the cardiotocogram ; quantitative measurement of FHR variation ; number of stillbirths .


With interactive advice to the operator , records were of improved quality ( up to 28 % without signal loss ) with potentially much reduced recording time .


The short-term FHR variation measured in the last records before intervention is reported for the first time .


The benefits of using the computers include improvement in record quality and saving of time .


In addition , where interpretation depended on estimation of FHR variation there was prima facie evidence of observer misinterpretation ; visual analysis was unreliable .


A larger trial is now required with more rigorous constraints on intervention .


Widespread use of 7-valent pneumococcal conjugate vaccine ( PCV7 ) in children has led to significant reduction in pneumococcal disease in children and adults .


However , diseases caused by serotypes not included in PCV7 have increased .


A 15-valent pneumococcal conjugate vaccine ( PCV15 ) containing serotypes in PCV7 and 8 additional serotypes ( 1 , 3 , 5 , 6A , 7F , 19A , 22F , 33F ) was developed and evaluated in toddlers 12 to 15 months of age .


Ninety toddlers who completed an infant series with PCV7 received a single dose of either aluminum-adjuvanted PCV15 , nonadjuvanted PCV15 , or PCV7 .


Injection-site and systemic adverse events ( AEs ) were collected for 14 days postvaccination and serious AEs ( SAEs ) were collected for 30 days postvaccination .


Solicited AEs included local ( pain/tenderness , swelling , nodule and redness ) and systemic ( fatigue , arthralgia and myalgia ) AEs .


Serotype-specific immunoglobulin G ( IgG ) and opsonophagocytic ( OPA ) responses were measured immediately prior and 30 days postvaccination .


Incidences of local and systemic AEs were comparable across vaccine groups .


The majority of reported events , regardless of vaccine received , were transient and of mild to moderate intensity .


No clinically significant differences were observed when comparing duration and severity of AEs .


No vaccine-related SAEs or discontinuations from the study due to AEs were reported .


Pneumococcal IgG concentrations and OPA titers increased postvaccination , with appreciable fold rises for all serotypes .


Antibody levels were comparable between both PCV15 formulations and generally comparable to PCV7 for the shared serotypes .


Both formulations of PCV15 display acceptable safety profiles and induce IgG and OPA responses to all vaccine serotypes .


The Feedback Intervention Trial was a national trial of an intervention to increase hand hygiene behavior in English and Welsh hospitals .


It significantly improved behavior , the effect increasing with fidelity to intervention , but the intervention proved more difficult to implement than anticipated .


This study aimed to identify the barriers to and facilitators of implementation as experienced by those who delivered the intervention .


Semistructured interviews were conducted with 17 intervention ward coordinators implementing the intervention .


Interview questions were based on the Theoretical Domains Framework .


Text relating to each domain was scored according to whether it indicated low or high likelihood of implementation , and thematic analysis conducted .


The lowest scoring domains were `` environmental context and resources , '' `` beliefs about capabilities , '' `` social influences , '' and `` emotion . ''


Lack of time and understaffing , perceived negativity from other staff members , and stress were identified as challenges to implementation .


The highest scoring domains were `` behavioral regulation , '' `` motivation , '' `` skills , '' `` knowledge , '' and `` professional role . ''


Ward coordinators reported that they had the skills , understanding , and motivation to implement the intervention and spoke of consistency of tasks with existing roles .


Implementation might be improved by giving designated time for intervention tasks and ensuring that the ward coordinator role is allocated to staff for whom tasks are commensurate with existing professional roles .


Up to 50 % of patients with schizophrenia are non-adherent with antipsychotic medication .


To establish the efficacy of adherence therapy ( AT ) compared to treatment as usual ( TAU ) in improving clinical outcomes in patients with schizophrenia following an acute exacerbation of illness .


A parallel-group , single-blind , randomised controlled trial .


Fieldwork was conducted in Thailand .


Patients received eight weekly sessions of AT in addition to TAU .


The primary outcome was improvement in psychopathology ( measured using the Positive and Negative Syndrome Scale ( PANSS ) ) at 26-week follow-up .


Secondary outcomes included patient attitudes towards medication , global functioning and side-effects .


In total , 70 inpatients with schizophrenia were recruited to the trial .


At 26-week follow-up , PANSS total scores improved in the AT compared to the TAU group by a mean of -3.94 points ( effect size = 0.24 ) .


The number needed to treat ( NNT ) was 5 .


There was no significant effect on patients ' attitudes towards treatment , functioning or medication side-effects .


No treatment-related adverse effects were reported .


AT improves psychopathology in Asian patients with schizophrenia following an acute exacerbation of illness .


To assess the long-term safety of the single-tablet combination of ibuprofen 800mg and famotidine 26.6 mg .


A phase 3b open-label study ( NCT00984815 ) was conducted in 86 adults requiring daily non-steroidal anti-inflammatory drug ( NSAID ) administration for 12 months .


The combination tablet of ibuprofen/famotidine was self-administered orally three times daily for up to 54 consecutive weeks .


Adverse events ( AEs ) were collected beginning at the first dose and continued through completion ( 54 weeks ) .


The Severity of Dyspepsia Assessment ( SODA ) questionnaire was completed by patients to assess tolerability .


Most patients ( 65 % ) finished the trial , with 76 % contributing data at 6 months , and 21 % withdrew due to adverse effects .


Overall and gastrointestinal AE discontinuation rates ( 21 % and 13 % , respectively ) were lower than that previously reported with ibuprofen 2400mg given alone .


Each of the SODA subscale scores demonstrated improvement by week 6 and improved statistically significantly at week 24 and week 54 .


Of the cardiovascular AEs , hypertension was reported most frequently ( 9/86 , 9.3 % ) , with 3.5 % determined to be drug related .


Twelve serious AEs were reported by 9 of 86 ( 10 % ) patients ; two were considered possibly related to the study medication ( unstable angina and gastric ulcer ) .


There were no reports of serious gastrointestinal or CV complications .


Most AEs were mild or moderate in severity and not considered drug related .


These data , together with previously reported findings of a significant decrease in upper gastrointestinal endoscopic ulcer rate at 6 months , support the overall safety , compliance , and tolerability of this single-tablet formulation .


To evaluate the effect of adjuvant chemotherapy ( ACT ) in locally advanced rectal cancer ( LARC ) after neoadjuvant chemoradiation ( NACT-RT ) .


The study was funded by the Italian National Research Council ( CNR ) .


From September 1992 to January 2001 , 655 patients with LARC ( clinically T3-4 , any N ) treated with NACT-RT and surgery , were randomized in two arms : follow-up ( Arm A ) or 6 cycles of ACT with 5 fluorouracil ( 5FU ) - Folinic Acid ( Arm B ) .


NACT-RT consisted of 45Gy/28/ff concurrent with 5FU ( 350mg/sqm ) and Folinic Acid ( 20mg/sqm ) on days 1-5 and 29-33 ; surgery was performed after 4-6weeks .


Median follow up was 637months .


Primary end point was overall survival ( OS ) .


634/655 patients were evaluable ( Arm A 310 , Arm B 324 ) ; 925 % of Arm A and 91 % of Arm B patients received the preoperative treatment as in the protocol ; 294 patients of Arm A ( 948 % ) and 296 of Arm B ( 913 % ) underwent a radical resection ; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms .


83/297 ( 28 % ) patients in Arm B , never started ACT .


Five year OS and DFS did not show any significant difference in the two treatment arms .


Distant metastases occurred in 62 patients ( 21 % ) in Arm A and in 58 ( 196 % ) in Arm B.


In patients with LARC treated with NACT-RT , the addition of ACT did not improve 5year OS and DFS and had no impact on the distant metastasis rate .


There is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory .


To describe cardiovascular disease ( CVD ) risk profiles and treatment of individual CVD risk factors by modelled CVD risk at diagnosis ; changes in treatment , modelled CVD risk , and CVD risk factors in the 5 years following diagnosis ; and how these are patterned by socioeconomic status .


Cohort analysis of a cluster-randomised trial ( ADDITION-Europe ) in general practices in Denmark , England , and the Netherlands .


A total of 2418 individuals with screen-detected diabetes were divided into quartiles of modelled 10-year CVD risk at diagnosis .


Changes in treatment , modelled CVD risk , and CVD risk factors were assessed at 5 years .


The largest reductions in risk factors and modelled CVD risk were seen in participants who were in the highest quartile of modelled risk at baseline , suggesting that treatment was offered appropriately .


Participants in the lowest quartile of risk at baseline had very similar levels of modelled CVD risk at 5 years and showed the least variation in change in modelled risk .


No association was found between socioeconomic status and changes in CVD risk factors , suggesting that treatment was equitable .


Diabetes management requires setting of individualised attainable targets .


This analysis provides a reference point for patients , clinicians , and policymakers when considering goals for changes in risk factors early in the course of the disease that account for the diverse cardiometabolic profile present in individuals who are newly diagnosed with type 2 diabetes .


Chronic subclinical volume overload happens very frequently in hemodialysis patients and is associated directly with hypertension , increased arterial stiffness , left ventricular hypertrophy , and ultimately higher mortality .


Randomized controlled parallel-group trial .


131 patients from one hemodialysis center , randomly assigned into 2 groups .


Dry weight prescription using results derived from repeated 3-month bioimpedance measurements to guide ultrafiltration for strict volume control ( bioimpedance group ; n = 62 ) compared with clinical judgment without bioimpedance measures ( clinical-methods group ; n = 69 ) for 2.5 years .


The primary outcome was all-cause mortality over 2.5 years ( the duration of the intervention ) .


Secondary outcomes were change in relative arterial stiffness , fluid overload , and blood pressure ( BP ) over 2.5 years .


Bioimpedance measurements were performed using a Body Composition Monitor device .


Pulse wave velocity analysis was performed at baseline , 2.5 years ( end of intervention ) , and 3.5 years ( end of study ) .


Relative fluid overload and BP were assessed at 3-month intervals .


The unadjusted HR for all-cause death in the bioimpedance group ( vs the clinical-methods group ) was 0.100 ( 95 % CI , 0.013-0 .805 ; P = 0.03 ) .


After 2.5 years , we found a greater decline in arterial stiffness , relative fluid overload , and systolic BP in the bioimpedance group than the clinical-methods group .


Between-group differences in change from baseline to the end of intervention were-2 .78 ( 95 % CI,-3 .75 to 1.80 ) m/s for pulse wave velocity ( P < 0.001 ) , -2.99 % ( 95 % CI,-5 .00 % to-0 .89 % ) for relative fluid overload ( P = 0.05 ) , and-2 .43 ( 95 % CI,-7 .70 to 2.84 ) mmHg for systolic BP ( P = 0.4 ) .


Echocardiography was not performed as cardiovascular assessment and the caregivers were not masked to the intervention .


Our study showed improvement in both surrogate and hard end points after strict volume control using bioimpedance to guide dry weight adjustment .


These findings need to be confirmed in a larger trial .


The efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal .


This study compared the safety and immunogenicity profiles of MF59-adjuvanted , trivalent , influenza vaccine ( ATIV ) and non-adjuvanted , trivalent , influenza vaccine ( TIV ) in Guatemalan children ( N = 360 ) between 6 and < 60 months of age .


Children received two doses of ATIV or TIV administered four weeks apart .


Solicited adverse reactions were recorded for seven days after each vaccination .


Serious adverse events were recorded throughout the entire study period .


Antibody responses were assessed by hemagglutination inhibition ( HI ) assay at baseline , four weeks after administration of the first vaccine dose , and three weeks after administration of the second dose .


Both ATIV and TIV were well tolerated , with similar rates of solicited reactions and adverse events observed in response to both vaccines .


MF59-adjuvanted vaccine induced considerably higher antibody titers than did TIV .


After two doses , the B strain-specific antibody response to TIV was insufficient to meet the Center for Biologics Evaluation and Research ( CBER ) licensure criterion for seroprotection , whereas responses to the MF59-adjuvanted vaccine met the seroprotection criterion against all three strains .


Cross-reactive antibody responses to MF59-adjuvanted vaccine met the CBER seroprotection criterion against all three strains after two doses ; B strain-specific heterologous responses to non-adjuvanted TIV were inadequate .


The MF59-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children 6 to < 60 months of age , inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains .


The authors compared the efficacy and tolerability of low and moderate dosages of extended-release quetiapine in adults with borderline personality disorder .


Ninety-five participants with DSM-IV borderline personality disorder were randomly assigned to receive 150 mg/day of quetiapine ( the low-dosage group ; N = 33 ) , 300 mg/day of quetiapine ( the moderate-dosage group ; N = 33 ) , or placebo ( N = 29 ) .


Total score over time on the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder ( `` Zanarini scale '' ) was analyzed in a mixed-effects model accounting for informative dropout .


Participants in the low-dosage quetiapine group had significant improvement on the Zanarini scale compared with those in the placebo group .


Time to response ( defined as a reduction of 50 % or more on the Zanarini scale total score ) was significantly shorter for both the low-dosage quetiapine group ( hazard ratio = 2.54 , p = 0.007 ) and the moderate-dosage quetiapine group ( hazard ratio = 2.37 , p = 0.011 ) than for the placebo group .


Among participants who completed the study , 82 % in the low-dosage quetiapine group were rated as `` responders , '' compared with 74 % in the moderate-dosage group and 48 % in the placebo group .


Treatment-emergent adverse events included sedation , change in appetite , and dry mouth .


The overall completion rate for the 8-week double-blind treatment phase was 67 % ( 67 % for the low-dosage quetiapine group , 58 % for the moderate-dosage quetiapine group , and 79 % for the placebo group ) .


Participants who experienced sedation were more likely to drop out .


Participants treated with 150 mg/day of quetiapine had a significant reduction in the severity of borderline personality disorder symptoms compared with those who received placebo .


Adverse events were more likely in participants taking 300 mg/day of quetiapine .


This study evaluates if there is any benefit of adding epinephrine to lidocaine in patients undergoing diagnostic rigid nasal endoscopy .


A prospective , randomized , double-blinded study was performed .


Seventy patients were randomized to receive either 2 % lidocaine or 2 % lidocaine with 0.2 % epinephrine before rigid nasal endoscopy examination .


Patients were asked to report the intensity of pain and discomfort they experienced using visual analog scale .


An endoscopist recorded the ease to perform the procedure using the same scale .


Intranasal structures visualized were also reported .


There were no significant differences in pain , discomfort or ease of exam , or in the percentage of visualized nasal structures between the two groups .


In the whole series , there were no significant differences in the studied variables based on gender or indication to perform endoscopy .


Adding epinephrine to lidocaine has no advantages in patients undergoing diagnostic rigid nasal endoscopy .


To compare the effects of a Chinese herbal suppository ( Jianpi suppository ) and Western Medicine ( mesalazine ) on hemorheology and CD62p in patients with ulcerative colitis ( UC ) .


In a randomized trial , 120 mild to moderate UC patients were randomly divided into two equal groups .


The Jianpi suppository group used Chinese herbal suppository rectally , while the mesalazine group was treated with mesalazine tablets orally .


Two 15-day courses of treatment were carried out in both groups .


Changes in the hemorheology and CD62p indices in patients were observed .


The hemorheology and CD62p indices in the Jianpi suppository group decreased significantly more than those of the mesalazine group .


Jianpi suppository is effective in improving the hypercoagulability of UC patients , and therefore may be worth using in clinical practice .


This study assessed the validity and usefulness of the Bayley Scales of Infant and Toddler Development , Third Edition ( Bayley-III ) Low Motor/Vision accommodated version .


Accommodations are adaptations to minimize impairment bias , without altering what the test measures .


Of the items , 66 % have Low Motor accommodations like enlarged materials ; 62 % have Low Vision accommodations .


Using a within-subject design , we tested 19 children with the accommodated and standard Bayley-III , in a randomly counterbalanced order .


The children had motor and/or visual impairment and a chronological age between 22 and 90 months .


The test administrators completed an evaluation form .


A subgroup of children benefited from the accommodations ; 2 children obtained a large raw score difference .


Test administrators considered the accommodations as practical , and advantageous for most children .


The Low Motor/Vision accommodated version seems to validly assess the development of this population .


Future , larger-scale research should study whether the accommodations improve the construct validity of the Bayley-III .


Fibroblast growth factor 23 ( FGF23 ) and Klotho are associated with vascular calcification and cardiovascular disease in dialysis patients .


Sevelamer has been shown to reduce progression of vascular calcification .


This study aimed to determine the long-term effect of sevelamer treatment on serum FGF23 and Klotho levels in chronic haemodialysis ( HD ) patients .


In the post-hoc analysis , we measured serum FGF23 , Klotho and other biochemical factors ( Ca , P , i-PTH , hsCRP , LDL-C ) in 50 haemodialysis patients , who completed a 48-week , open-Label , controlled randomized parallel-group study .


Twenty-three patients received sevelamer and 27 patients received calcium carbonate .


After 48-week sevelamer treatment , there were significant changes with lower LDL-C ( from 2.820.78 to 1.650.53 mmol/L , P = 0.000 ) , lower FGF23 ( from 2465.97 ( 2568.88 ) to 795.61 ( 1098.39 ) , P = 0.000 ) and higher s-Klotho levels ( from 189.35 ( 161.88 ) to 252.94 ( 517.80 ) pg/mL , P = 0.000 ) .


In calcium carbonate group , there were no significant changes of LDL-C and FGF23 , but with a borderline significant increase of s-Klotho level ( from 142.34 ( 265.24 ) to 188.57 ( 252.38 ) pg/mL , P = 0.054 ) .


Multivariate analysis showed that FGF23 decrement was associated with sevelamer treatment ( = -0.277 , P = 0.005 ) , change of serum phosphate ( = 0.609 , P = 0.000 ) and calcium levels ( = 0.635 , P = 0.000 ) .


The increase of serum Klotho was associated with the decrease of serum phosphate ( = 0.490 , P = 0.019 ) .


Maintenance HD patients had lower serum FGF23 levels , accompanied with significantly increased serum Klotho levels , after 48-week sevelamer treatment .


The FGF23 decrement was associated with sevelamer use , the change of serum phosphate and calcium levels .


The serum Klotho increment was proportional to the phosphate-lowering power of the binders .


To compare the efficacy and tolerability of monotherapy with phenazepam to complex treatment with the peptide preparation selank and phenazepam in patients with anxiety disorders .


Authors explored the anxiolytic effect and tolerability of monotherapy with phenazepam ( 30 patients ) and complex treatment with selank and phenazepam ( 40 patients ) in anxiety-phobic , hypochondriac and somatoform disorders ( ICD-10 items F40.2-9 , F41.1-9 , F45.0-2 ) .


Therapeutic effect was assessed clinically and with HDRS , CGI and Spilberger scales .


Tolerability was evaluated using the UKU scale .


Stroop test and verbal fluency test were used .


Quality of life was assessed with the SF-36 .


The positive effect of phenazepam was achieved earlier in the optimization of treatment with selank on HDRS .


The combined treatment decreased the level of undesirable side-effects of phenazepam ( attention and memory impairment , asthenia , sedation , increase in sleep duration , sexual disturbances , emotional indifference and orthostatism ) during the course of treatment and after the tranquilizer withdrawal .


Taken together , the therapeutic efficacy and reduction of side-effects had a positive impact on the quality-of-life of the patients treated with selank as add-on to phenazepam .


The results extend therapeutic possibilities of treatment of anxietyspectrum disorders with the combination of benzodiazepine tranquilizers and selank .


This study aimed to evaluate the long-term effects on glycemic control of a diabetes care program focusing on case management and to discuss challenges in the quality of diabetes care in Taiwan .


We randomized 1,060 study subjects recruited from the Diabetes Management through an Integrated Delivery System project in 2003-2005 into intervention ( n = 789 from 27 clinics ) and control ( n = 271 from 7 clinics ) groups .


The quarterly self-care and nutrition-education program in the intervention group was delivered by case managers , and standard care was provided to the control group .


The intervention program was conducted during 2003-2007 .


A multivariate mixed model analysis was used to assess the 3.5-year intervention effects on glycemic control .


Glycated hemoglobin ( HbA1c ) level in the intervention group ( especially for those with a baseline HbA1c level of 7-9 % and > 9 % ) was significantly lower than that in the control group 6 months after recruitment and remained lower through the subsequent three intervention years .


The current findings provide evidence that case management provided in the pay-for-performance ( P4P ) diabetes care program in Taiwan was effective at improving glycemic control for at least 3 years .


However , previous research indicated poverty is associated with not only higher diabetes incidence but also inequality of diabetes care in Taiwan despite universal health coverage .


Those with a more severe condition were less likely to be enrolled in the P4P diabetes care program .


Additional cost-effectiveness studies and more health policy reforms are needed to optimize diabetes care in Taiwan .


The goal of this study was to assess the effects of training primary care providers ( PCPs ) to use Motivational Interviewing ( MI ) when treating depressed patients on providers ' MI performance and patients ' expressions of interest in depression treatment ( `` change talk '' ) and short-term treatment adherence .


This was a cluster randomized trial in urban primary care clinics ( 3 intervention , 4 control ) .


We recruited 21 PCPs ( 10 intervention , 11 control ) and 171 English-speaking patients with newly diagnosed depression ( 85 intervention , 86 control ) .


MI training included a baseline and up to 2 refresher classroom trainings , along with feedback on audiotaped patient encounters .


We report summary measures of technical ( rate of MI-consistent statements per 10 minutes during encounters ) and relational ( global rating of `` MI Spirit '' ) MI performance , the association between MI performance and number of MI trainings attended ( 0 , 1 , 2 , or 3 ) , and rates of patient change talk regarding depression treatments ( physical activity , antidepressant medication ) .


We report PCP use of physical activity recommendations and antidepressant prescriptions and patients ' short-term physical activity level and prescription fill rates .


Use of MI-consistent statements was 26 % higher for MI-trained versus control PCPs ( P = .005 ) .


PCPs attending all 3 MI trainings ( n = 6 ) had 38 % higher use of MI-consistent statements ( P < .001 ) and were over 5 times more likely to show beginning proficiency in MI Spirit ( P = .036 ) relative to control PCPs .


Although PCPs ' use of physical activity recommendations and antidepressant prescriptions was not significantly different by randomization arm , patients seen by MI-trained PCPs had more frequent change talk ( P = .001 ) .


Patients of MI-trained PCPs also expressed change talk about physical activity 3 times more frequently ( P = .01 ) and reported more physical activity ( 3.05 vs 1.84 days in the week after the visit ; P = .007 ) than their counterparts visiting untrained PCPs .


Change talk about antidepressant medication and fill rates were similar by randomization arm ( P > .05 for both ) .


MI training resulted in improved MI performance , more depression-related patient change talk , and better short-term adherence .


Radical cystectomy ( RC ) for bladder cancer is frequently associated with delayed gastrointestinal ( GI ) recovery that prolongs hospital length of stay ( LOS ) .


To assess the efficacy of alvimopan to accelerate GI recovery after RC .


We conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics .


Oral alvimopan 12 mg ( maximum : 15 inpatient doses ) versus placebo .


The two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) GI recovery ( GI-2 ) .


Time to discharge order written , postoperative LOS , postoperative ileus ( POI ) - related morbidity , opioid consumption , and adverse events ( AEs ) were evaluated .


An independent adjudication of cardiovascular AEs was performed .


Patients were randomized to alvimopan ( n = 143 ) or placebo ( n = 137 ) ; 277 patients were included in the modified intention-to-treat population .


The alvimopan cohort experienced quicker GI-2 recovery ( 5.5 vs 6.8 d ; hazard ratio : 1.8 ; p < 0.0001 ) , shorter mean LOS ( 7.4 vs 10.1 d ; p = 0.0051 ) , and fewer episodes of POI-related morbidity ( 8.4 % vs 29.1 % ; p < 0.001 ) .


The incidence of opioid consumption and AEs or serious AEs ( SAEs ) was comparable except for POI , which was lower in the alvimopan group ( AEs : 7 % vs 26 % ; SAEs : 5 % vs 20 % , respectively ) .


Cardiovascular AEs occurred in 8.4 % ( alvimopan ) and 15.3 % ( placebo ) of patients ( p = 0.09 ) .


Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy .


Alvimopan is a useful addition to a standardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS , with a safety profile similar to placebo .


This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer .


Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety .


ClinicalTrials.gov identifier NCT00708201 .


To evaluate the effect of 1 ) patient values as expressed by family members and 2 ) a requirement to document patients ' functional prognosis on intensivists ' intention to discuss withdrawal of life support in a hypothetical family meeting .


A three-armed , randomized trial .


One hundred seventy-nine U.S. hospitals with training programs in critical care accredited by the Accreditation Council for Graduate Medical Education .


Six hundred thirty intensivists recruited via e-mail invitation from a database of 1,850 eligible academic intensivists .


Each intensivist was randomized to review 10 , online , clinical scenarios with a range of illness severities involving a hypothetical patient ( Mrs. X ) .


In control-group scenarios , the patient did not want continued life support without a reasonable chance of independent living .


In the first experimental arm , the patient wanted life support regardless of functional outcome .


In the second experimental arm , patient values were identical to the control group , but intensivists were required to record the patient 's estimated 3-month functional prognosis .


Response to the question : `` Would you bring up the possibility of withdrawing life support with Mrs. X 's family ? ''


answered using a five-point Likert scale .


There was no effect of patient values on whether intensivists intended to discuss withdrawal of life support ( p = 0.81 ) , but intensivists randomized to record functional prognosis were 49 % more likely ( 95 % CI , 20-85 % ) to discuss withdrawal .


In this national , scenario-based , randomized trial , patient values had no effect on intensivists ' decisions to discuss withdrawal of life support with family .


However , requiring intensivists to record patients ' estimated 3-month functional outcome substantially increased their intention to discuss withdrawal .


To determine women 's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour .


Multicentre randomised controlled equivalence trial .


15 hospitals in the Netherlands .


Women with an intermediate to high obstetric risk with an intention to deliver vaginally .


To exclude a clinically relevant difference in satisfaction with pain relief of more than 10 % , we needed to include 1136 women .


Because of missing values for satisfaction this number was increased to 1400 before any analysis .


We used multiple imputation to correct for missing data .


Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour .


Primary outcome was satisfaction with pain relief , measured hourly on a visual analogue scale and expressed as area under the curve ( AUC ) , thus providing a time weighted measure of total satisfaction with pain relief .


A higher AUC represents higher satisfaction with pain relief .


Secondary outcomes were pain intensity scores , mode of delivery , and maternal and neonatal outcomes .


Analysis was done by intention to treat .


The study was defined as an equivalence study for the primary outcome .


1414 women were randomised , of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia .


Baseline characteristics were comparable .


Pain relief was ultimately used in 65 % ( 447/687 ) in the remifentanil group and 52 % ( 347/671 ) in the epidural analgesia group ( relative risk 1.32 , 95 % confidence interval 1.18 to 1.48 ) .


Cross over occurred in 7 % ( 45/687 ) and 8 % ( 51/671 ) of women , respectively .


Of women primarily treated with remifentanil , 13 % ( 53/402 ) converted to epidural analgesia , while in women primarily treated with epidural analgesia 1 % ( 3/296 ) converted to remifentanil .


The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group ( mean difference -2.8 , 95 % confidence interval -6.9 to 1.3 ) .


For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group ( mean difference -10.4 , -13.9 to -7.0 ) .


The rate of caesarean section was 15 % in both groups .


Oxygen saturation was significantly lower ( SpO2 < 92 % ) in women who used remifentanil ( relative risk 1.5 , 1.4 to 1.7 ) .


Maternal and neonatal outcomes were comparable between both groups .


In women in labour , patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief .


Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia .


Netherlands Trial Register NTR2551 .


TTP488 , an antagonist at the Receptor for Advanced Glycation End products , was evaluated as a potential treatment for patients with mild-to-moderate Alzheimer 's disease ( AD ) .


A previous report describes decreased decline in ADAS-cog ( delta = 3.1 , p = 0.008 at 18 months , ANCOVA with multiple imputation ) , relative to placebo , following a 5 mg/day dose of TTP488 .


Acute , reversible cognitive worsening was seen with a 20 mg/day dose .


The present study further evaluates the efficacy of TTP488 by subgroup analyses based on disease severity and concentration effect analysis .


399 patients were randomized to one of two oral TTP488 doses ( 60 mg for 6 days followed by 20 mg/day ; 15 mg for 6 days followed by 5 mg/day ) or placebo for 18 months .


Pre-specified primary analysis , using an ITT population , was on the ADAS-cog11 .


Secondary analyses included as a key secondary variable the Clinical Dementia Rating-Sum of Boxes ( CDR-SB ) , and another secondary variable of the ADCS-ADL .


On-treatment analysis demonstrated numerical differences favoring 5 mg/day over placebo , with nominal significance at Month 18 ( delta = 2.7 , p = 0.03 ) .


Patients with mild AD , whether defined by MMSE or ADAS-cog , demonstrated significant differences favoring 5 mg/day on ADAS-cog and trends on CDR-sb and ADCS-ADL at Month 18 .


TTP488 plasma concentrations of 7.6-16 .8 ng/mL were associated with a decreased decline in ADAS-cog over time compared to placebo .


Worsening on the ADAS-cog relative to placebo was evident at 46.8-167 .0 ng/mL .


Results of these analyses support further investigation of 5 mg/day in future Phase 3 trials in patients with mild AD .


The Sibutramine Cardiovascular OUTcomes ( SCOUT ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise .


We examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events .


A total of 9804 male and female subjects , aged 55 years or older , with a body mass index of 27-45kgm ( -2 ) were included in this current subanalysis of the SCOUT trial .


Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes .


Post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( 6-week sibutramine followed by randomized placebo or continued sibutramine ) .


The primary outcome event ( POE ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death .


Time-to-event analyses of the POE were performed using Cox regression models with factors for treatment , subgroups and interactions .


During the initial 6-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -8.110.5 mmHg with < 5kg weight loss to -10.811.0 mmHg with 5kg weight loss ) .


The highest POE incidence occurred mainly in groups with increases in both weight and blood pressure .


However , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase POEs .


Modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected .


However , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population .


Breast neoplasms are the second most common type of cancer worldwide , and radiation therapy is a key component of their treatment .


Acute skin reactions are one of the most common side effects of radiation therapy , and prevention of this adverse event has been investigated in several studies .


However , a clinically applicable , preventative treatment remains unavailable .


It has been demonstrated that application of a low-power laser can promote tissue repair .


Therefore , the aim of this trial is to evaluate the effectiveness of an indium gallium aluminum phosphorus ( InGaAIP ) laser operated at 660nm in preventing radiodermatitis in women undergoing adjuvant radiotherapy for breast cancer .


This is a two-arm , randomized controlled trial .


A total of 52 patients undergoing radiotherapy for breast cancer ( stages I to III ) will be enrolled .


Patients will be randomly assigned to an intervention group to receive laser therapy ( n = 26 ) or a control group to receive a placebo ( n = 26 ) .


The laser or placebo will be applied five days a week , immediately before each radiotherapy session .


Skin reactions will then be graded weekly by a nurse , a radiotherapist , and an oncologist ( all of whom will be blinded ) using the Common Toxicity Criteria ( CTC ) developed by the National Cancer Institute and the Acute Radiation Morbidity Scoring Criteria developed by the Radiation Therapy Oncology Group .


Patients will also answer a modified visual analogue scale for pain ( a self-evaluation questionnaire ) .


Primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis , respectively .


The ideal tool for preventing radiodermatitis is an agent that mediates DNA repair or promotes cell proliferation .


Application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis .


Moreover , this treatment approach has not been associated with adverse events and is cost-effective .


Thus , the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis .


ClinicalTrials.gov identifier : NCT02003599 .


Registered on 2 December 2013 .


To compare intercostal nerve block before and after rib harvest in terms of mean postoperative pain score and mean postoperative tramadol usage .


Randomized controlled trial .


Department of Plastic Surgery , Mayo Hospital , KEMU , Lahore , from January 2011 to July 2012 .


Patients ( n = 120 ) of either gender with ASA class-I and II requiring autogenous costal cartilage graft were inducted .


Patients having history of local anaesthetic hypersensitivity and age < 15 years or > 60 years were excluded .


Subjects were randomly assigned to pre-rib harvest ( group-1 ) and post-rib harvest ( group-2 ) .


Local anaesthetic mixture was prepared by adding 10 milliliters 2 % lidocaine to 10 milliliters 0.5 % bupivacaine to obtain a total 20 ml solution .


Group-1 received local anaesthetic infiltration along the proposed incision lines and intercostals block before the rib harvest .


Group-2 received the infiltration and block after rib harvest .


Postoperative consumption of tramadol and pain scores were measured at 6 and 12 hours postoperatively using VAS .


Mean age was 31.43 10.78 years .


The mean pain scores at 6 hours postoperatively were 1.033 0.609 and 2.4667 0.812 in pre-rib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .


The mean pain scores at 12 hours postoperatively were 1.45 0.565 and 3.65 0.633 in pre-rib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .


The mean tramadol used postoperatively in first 24 hours was 169 29.24 mg and 255 17.70 mg in prerib harvest and post-rib harvest groups respectively ( p < 0.0001 ) .


Intercostal block administered before rib harvest as preemptive strategy result in decreased postoperative pain scores and narcotic use .


The aim of this study was assessment of subendometrial blood flow with Doppler ultrasonography as an indicator of endometrial receptivity in stimulated cycles for intrauterine insemination ( IUI ) .


This prospective study enrolled 90 women scheduled for IUI after ovarian stimulation randomly assigned to one of the three equal groups ; group ( C ) received Clomiphene citrate , group ( H ) received HMG and group ( CH ) received Clomiphene citrate in addition to HMG .


All participants had ultrasound folliculometry starting on day 9 , followed by transvaginal Doppler study of the subendometrial blood flow and perifollicular blood flow on the day of detecting at least one follicle > 18mm .


Resistivity index ( RI ) and pulsatility index ( PI ) of subendometrial and perifollicular flow were measured .


Endometrial thickness was measured on day of hCG injection .


Group ( H ) showed significantly higher frequency of subendometrial flow ( 80 % ) compared to the other two groups ( p = 0.009 ) .


In cases of positive subendometrial flow , the RI and PI were significantly lower in group ( H ) compared to the other two groups ( p = 0.007 and 0.012 , respectively ) .


Endometrial thickness was significantly lower in group ( C ) compared to group ( H ) ( p < 0.001 ) and group ( CH ) ( p < 0.001 ) .


Successful intrauterine implantation was documented in a total of 16 women ( 17.8 % ) ; the highest frequency was in group ( H ) ( 23.3 % ) and the lowest in group ( C ) , however , the difference between the three groups was not significant ( p = 0.372 ) .


Subendometrial indices and perifollicular RI were significantly lower in cases of successful implantation , while endometrium was significantly thicker in these cases ( p < 0.001 ) .


The presence of subendometrial flow is associated with successful IUI in women under stimulated cycles undergoing IUI .


HMG seems a superior option for induction of ovulation regarding success of implantation .


To determine whether a single exposure to a Manga comic ( Japanese comic art ) with multiple messages promoting fruit intake influenced snack selection in minority urban youth .


Fifty-seven youth ( mean age 10.8 y ; 54 % female ; 74 % black/African American ) attending after-school programs in Brooklyn , NY participated in a pilot study in which they were randomly assigned to receive the comic or a non-health-related newsletter .


After reading their media , participants were offered a snack and could choose from among healthy/unhealthy options .


Secondary outcomes included knowledge , self-efficacy , and outcome expectations related to fruit intake and media transportation .


Data were analyzed using regression and paired t test .


Comic group participants were significantly more likely to choose a healthy snack , compared to the Attention-control group ( odds ratio = 3.6 , 95 % confidence interval : 1.1-12 .1 , P = .04 ) .


The Comic group reported increases in self-efficacy ( P = .04 ) and greater transportation ( immersion into media ) ( P = .006 ) .


Results suggest Manga comics may be a useful format to promote healthy snack selection in urban minority youth .


Renal failure patients were treated with linezolid ( LZD ) for proven or suspected infections by multi-resistant Gram-positive cocci .


The aim of this study was to determine if dose adjustment of LZD is needed as a function of renal impairment or not , especially that a significant component of LZD is eliminated unchanged in urine .


The single dose pharmacokinetics of LZD was investigated .


Eighteen non-infected male subjects with various degrees of renal impairment ranged from normal to severe chronic impairment were enrolled , including end-stage renal disease ( ESRD ) patients maintained on hemodialysis ( HD ) .


LZD was administered as a single oral 600mg dose , and blood samples were drawn at different times and analysed by a validated HPLC assay method .


Plasma profiles were evaluated by non-compartmental and compartmental approaches .


A similar rate and extent of LZD absorption and elimination and comparable body exposure was observed in both healthy subjects and acute renal failure patients .


The extent of LZD exposure was significantly increased by 3-fold in ESRD patients in their off-dialysis day .


Furthermore , the t1/2 and MRT values were significantly increased by ~ 5 - and 3-fold , respectively .


The Vd / F values of LZD did not change with renal function .


A significant decrease in CL/F by ~ 3-fold was observed in ESRD patients in their off-dialysis day however , CL/F was significantly increased by ~ 4-fold during HD .


Approximately half of the administered LZD dose was removed during the HD session in these selected cohorts of ESRD patients .


LZD was generally well tolerated .


The dose of LZD did not need to be adjusted for patients with acute renal dysfunction or ESRD on HD .


One of the twice-daily doses should be administered after the dialysis session because almost half of the LZD dose was substantially removed by HD .


During the first three dialysis sessions of the treatment course , to avoid potentially ineffective therapy , a supplemental dose of LZD might be given if necessary or the dose of LZD should be administered 4h before the beginning of the HD session .


This was to keep LZD levels above the MIC for the organism causing the infection being treated .


Changes in diet and exercise have been separately demonstrated to improve Depression , although scientific evidence available is scarce .


In a previously published controlled study , just recommending these and other lifestyle measures ( sleep restriction and sunlight exposure ) in combination once , patients experienced improvements in their depressive symptoms six months later .


In this sample , one in three depressive patients had metabolic syndrome ( MetS ) at baseline .


First line treatment of MetS condition is hygienic-dietetic , being Mediterranean diet and exercise especially important .


Therefore we analyzed if lifestyle recommendations also improved their metabolic profile .


During the sixth month evaluation , a smaller number of patients from the group receiving hygienic-dietary recommendations met MetS criteria comparing with the control group .


This study suggests that costless lifestyle recommendations , such as exercise and Mediterranean diet , have the capacity to promote both mental and physical health in a significant proportion of depressive patients .


Further research is needed to confirm or discard these preliminary findings .


To assess the effects of oral and transdermal hormone replacement therapies ( HRT ) on levels of important cardiovascular disease ( CVD ) markers , MCP-1 and homocyteine , in the early postmenopausal period .


Seventy-six healthy , early postmenopausal women were enrolled in the study .


Patients were randomly assigned to receive oral or transdermal HRT for 6 months .