The results show that vocational programs in rehabilitation need to be revised , including with regard to the question , whether and in what way post-treatment proposals must be changed .


Long-term tenofovir disoproxil fumarate ( TDF ) treatment for chronic hepatitis B ( CHB ) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 ( 240 weeks ) and no TDF resistance through 6 years ( 288 weeks ) .


We assessed the efficacy , safety , and resistance of TDF for up to 7 years ( 336 weeks ) in HBeAg-positive and HBeAg-negative CHB patients .


Patients who completed 1 year ( 48 weeks ) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years ( 384 weeks ) .


Of 641 patients initially randomized , 585 ( 91.3 % ) entered the open-label phase ; 437/585 ( 74.7 % ) remained on study at year 7 .


For patients on treatment at year 7 , 99.3 % maintained viral suppression ( HBV DNA < 69 IU/mL ) , 80.0 % achieved serum alanine aminotransferase normalization , and in HBeAg-positive patients , 84/154 ( 54.5 % ) and 25/154 ( 11.8 % ) achieved HBeAg and HBsAg loss , respectively .


One/375 ( 0.3 % ) HBeAg-negative patients achieved HBsAg loss .


No resistance to TDF was detected through 7 years .


During the open-label phase , grade 3/4 drug-related adverse events were uncommon ( 1.0 % ) ; ten ( 1.7 % ) patients had elevation of serum creatinine 0.5 mg/dL above baseline .


No significant change in bone mineral density was observed from year 4 to year 7 ( week 192 to week 336 ) .


Long-term TDF treatment was associated with sustained virologic , biochemical , and serologic responses , without resistance .


TDF treatment was well tolerated , with a low incidence of renal and bone events .


These data confirm the safety and efficacy of long-term TDF for CHB .


The aims of this analysis were to examine levels of unmet needs and depression among carers of people newly diagnosed with cancer and to identify groups who may be at higher risk , by examining relationships with demographic characteristics .


One hundred and fifty dyads of people newly diagnosed with cancer and their carers , aged 18 years and older , were recruited from four Australian hospitals .


People with cancer receiving adjuvant cancer treatment with curative intent , were eligible to participate .


Carers completed the Supportive Care Needs Survey-Partners & Caregivers ( SCNS-P & C45 ) , and both carers and patients completed the Centre of Epidemiologic-Depression Scale ( CES-D ) .


Overall , 57 % of carers reported at least one , 37 % at least three , 31 % at least five , and 15 % at least 10 unmet needs ; the most commonly endorsed unmet needs were in the domains of information and health care service needs .


Thirty percent of carers and 36 % of patients were at risk of clinical depression .


A weak to moderate positive relationship was observed between unmet needs and carer depression ( r = 0.30 , p < 0.001 ) .


Carer levels of unmet needs were significantly associated with carer age , hospital type , treatment type , cancer type , living situation , relationship status ( in both uni - and multi-factor analysis ) ; person with cancer age and carer level of education ( in unifactor analysis only ) ; but not with carer gender or patient gender ( in both uni - and multi-factor analyses ) .


Findings highlight the importance of developing tailored programmes to systematically assist carers who are supporting patients through the early stages of cancer treatment .


To further our understanding of central sleep apnea ( CSA ) at high altitude during acclimatization , we tested the hypothesis that pharmacologically altering cerebral blood flow ( CBF ) would alter the severity of CSA at high altitude .


The study was a randomized , placebo-controlled single-blind study .


A field study at 5,050 m in Nepal .


We studied 12 normal volunteers .


Between days 5 to 10 at high altitude , CBF velocity ( CBFv ) was increased by intravenous ( IV ) acetazolamide ( 10 mg/kg ) and reduced by oral indomethacin ( 100 mg ) .


Arterial blood gases , hypoxic and hypercapnic ventilatory responses , and CBFv and its reactivity to carbon dioxide were measured awake .


Overnight polysomnography was performed .


The central apnea-hypopnea index was elevated following administration of indomethacin ( 89.2 43.7 to 112.5 32.9 events/h ; mean standard deviation ; P < 0.05 ) and was reduced following IV acetazolamide ( 89.2 43.7 to 47.1 48.1 events/h ; P < 0.001 ) .


Intravenous acetazolamide elevated CBFv at high altitude by 28 % ( 95 % confidence interval [ CI ] : 22-34 % ) but did not affect ventilatory responses .


The elevation in CBFv was partly mediated via a selective rise in partial pressure of arterial carbon dioxide ( PaCO2 ) ( 28 4 to 31 3 mm Hg ) and an associated fall in pH ( P < 0.01 ) .


Oral indomethacin reduced CBFv by 23 % ( 95 % CI : 16-30 % ) , blunted CBFv reactivity , and increased the hypercapnic ventilatory response by 66 % ( 95 % CI : 30-102 % ) but had no effect on PaCO2 or pH.


Our findings indicate an important role for cerebral blood flow regulation in the pathophysiology of central sleep apnea at high altitude .


Dipeptidyl-peptidase 4 ( DPP4 ) inhibitors improve glycemic control in patients with diabetes mellitus by preventing the degradation of glucagon-like peptide-1 ( GLP-1 ) .


GLP-1 causes vasodilation in animal models but also increases sympathetic activity ; the effect of GLP-1 in the human vasculature and how it is altered by DPP4 inhibition is not known .


DPP4 also degrades the vasodilator brain natriuretic peptide ( BNP ) to a less potent metabolite .


This study tested the hypothesis that DPP4 inhibition potentiates the vasodilator responses to GLP-1 and BNP in the human forearm .


Seventeen healthy subjects participated in this randomized , double-blinded , placebo-controlled crossover study .


On each study day , subjects received DPP4 inhibitor ( sitagliptin 200 mg by mouth ) or placebo .


Sitagliptin increased forearm blood flow and decreased forearm vascular resistance without affecting mean arterial pressure and pulse .


GLP-1 and BNP were infused in incremental doses via brachial artery .


Venous GLP-1 concentrations were significantly higher during sitagliptin use , yet there was no effect of GLP-1 on forearm blood flow in the presence or absence of sitagliptin .


BNP caused dose-dependent vasodilation ; however , sitagliptin did not affect this response .


GLP-1 and BNP had no effect on net norepinephrine release .


These data suggest that GLP-1 does not act as a direct vasodilator in humans and does not contribute to sympathetic activation .


Sitagliptin does not regulate vascular function in healthy humans by affecting the degradation of GLP-1 and BNP .


www.clinicaltrials.gov / Unique identifier : NCT01413542 .


To observe the efficacy of thread-moxa in Zhuang folk medicine ( TM ) combined with acupuncture and external application drugs for AIDS patients with herpes zoster ( AHZ ) .


A randomized , controlled clinical trial was conducted in 60 patients with AHZ .


They were randomly assigned to the treatment group ( treated with TM combined with acupuncture and Jingwanhong Scald Ointment ) and the control group ( treated with Famciclovir Tablet , nimesulide dispersible tablet , vitamin B1 , ribavirin ointment ) .


The treatment course was 14 days for both groups.The clinical efficacy , significant efficiency visual analog scale score ( VAS ) , sleep quality score ( QS ) , the postherpetic neuralgia rate in 1 year after treatment were observed .


The markedly effective rate was significantly higher in the treatment group than in the control group ( 86.7 % vs. 53.3 % , P < 0.01 ) .


There was no statistical difference in the total effective rate between the two groups ( 96.7 % vs. 80.0 % , P > 0.05 ) .


The post-treatment VAS , QS , the time for pain disappearance , skin repair , crusting , and 1-year postherpetic neuralgia incidence rate were significantly lower in the treatment group than in the control group ( P < 0.05 , P < 0.01 ) .


TM combined with acupuncture and Jingwanhong Scald Ointment was effective for treating AHZ patients .


It relieved pain quickly , shortened their course of disease , and improved their quality of sleep .


To determine whether acupuncture is effective as an overactive bladder ( OAB ) treatment compared with solifenacin and placebo , and to investigate its relation with urine nerve growth factor ( NGF ) levels .


The study was conducted with methodological rigor based on the Consolidated Standards of Reporting Trials criteria .


90 female patients with OAB were included and randomly assigned to a solifenacin , acupuncture or placebo group .


The medicated group received solifenacin 5 mg/day ; the acupuncture and placebo groups were treated twice a week for 4 weeks .


Symptom scores , quality of life scores , frequency of micturition and urine NGF levels were used to assess treatment efficiency .


The study was completed with 82 patients ( n = 30 in the solifenacin group , n = 28 in the acupuncture group and n = 24 in the placebo group ) .


After treatment , comparison of the medical and acupuncture therapy groups with the placebo group showed significant differences between recovery concerning quality of life ( p < 0.001 and p < 0.01 , respectively ) and symptom scores ( p < 0.001 and p < 0.001 , respectively ) .


The decrease of NGF levels after treatment compared to before treatment was determined in each group ( solifenacin , acupuncture , placebo group ; p < 0.001 , p < 0.001 , p = 0.359 , respectively ) .


Sufficient symptomatic improvement was not achieved in 8 patients in the acupuncture group .


Therefore , comparisons were assessed twice with and without including these patients , and NGF levels in the acupuncture group were higher than at first comparison in which all patients in the acupuncture group were included .


In patients with OAB in whom anticholinergic treatment is contraindicated , acupuncture may be considered another treatment option .


To explore whether subjects harbouring A. actinomycetemcomitans , P. gingivalis or T. forsythia at baseline showed increased clinical benefits with the adjunctive use of systemic amoxicillin and metronidazole ( AMX-MET ) during non-surgical treatment of generalized aggressive periodontitis ( GAgP ) .


Forty one subjects were included in this 6-month randomized placebo-controlled clinical trial using a 7-day course of systemic AMX-MET or placebo as adjuncts to non-surgical periodontal therapy .


Clinical and microbiological parameters were collected at baseline , 2 and 6months after treatment .


Microbiological cultures were processed for pooled subgingival samples and identities of isolates were determined by PCR for A. actinomycetemcomitans , P. gingivalis and T. forsythia


At 6months , the test treatment resulted in significant additional improvements in the primary outcome variable compared to placebo , and the effect of the adjunctive antimicrobials was not modified by the baseline microbiological status in the primary analysis .


However , secondary exploratory subgroup analyses showed improved clinical outcomes in subjects harbouring A. actinomycetemcomitans at baseline compared to subjects who did not harbour this pathogen .


All subjects benefited from the tested adjunctive antimicrobial regimen , although subjects who harboured A. actinomycetemcomitans at baseline may show greater clinical benefits .


Larger appropriately powered studies are needed to confirm whether adjunctive AMX-MET is more beneficial for GAgP patients who harbour A. actinomycetemcomitans , along with other key periodontal pathogens .


The authors investigated the effect of remifentanil administration on resting electroencephalography functional connectivity and its relationship to cognitive function and analgesia in healthy volunteers .


Twenty-one healthy male adult subjects were enrolled in this placebo-controlled double-blind cross-over study .


For each subject , 2.5 min of multichannel electroencephalography recording , a cognitive test of sustained attention ( continuous reaction time ) , and experimental pain scores to bone-pressure and heat stimuli were collected before and after infusion of remifentanil or placebo .


A coherence matrix was calculated from the electroencephalogram , and three graph-theoretical measures ( characteristic path-length , mean clustering coefficient , and relative small-worldness ) were extracted to characterize the overall cortical network properties .


Compared to placebo , most graph-theoretical measures were significantly altered by remifentanil at the alpha and low beta range ( 8 to 18 Hz ; all P < 0.001 ) .


Taken together , these alterations were characterized by an increase in the characteristic path-length ( alpha 17 % and low beta range 24 % ) and corresponding decrements in mean clustering coefficient ( low beta range -25 % ) and relative small-worldness ( alpha -17 % and low beta range -42 % ) .


Changes in characteristic path-lengths after remifentanil infusion were correlated to the continuous reaction time index ( r = -0.57 ; P = 0.009 ) , while no significant correlations between graph-theoretical measures and experimental pain tests were seen .


Remifentanil disrupts the functional connectivity network properties of the electroencephalogram .


The findings give new insight into how opioids interfere with the normal brain functions and have the potential to be biomarkers for the sedative effects of opioids in different clinical settings .


Patients with several painful functional gastrointestinal disorders ( FGIDs ) are reported to have a high prevalence of psychosocial disturbance .


These aspects have not been studied extensively in patients with suspected Sphincter of Oddi dysfunction ( SOD ) .


A total of 214 patients with post-cholecystectomy pain and suspected SOD were enrolled in seven US centers in a multicenter-randomized trial ( Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction ) .


Baseline assessments included pain descriptors and burden , structured psychosocial assessments of anxiety/depression , coping , trauma , and health-related quality of life .


Patients with high levels of depression , suicidal ideation , or psychosis were excluded .


The study population ( 92 % female , mean age 38 ) reported anxiety ( 9 % ) , depression ( 8 % ) , past sexual trauma ( 18 % ) , and physical abuse ( 10 % ) .


Of the total screened population ( n = 1460 ) , 3.9 % of the patients were excluded because of the presence of defined severe psychological problems .


The mean medical outcomes study short-form-36 ( SF-36 ) physical and mental composite scores were 38.70 ( s.d. = 7.89 ) and 48.74 ( s.d. = 9.60 ) , respectively .


Most subjects reported symptoms of other FGIDs .


There were no correlations between the extent of the pain burden in the 3 months before enrollment and the baseline anxiety scores or victimization history .


However , those with greater pain burden were significantly more depressed .


There were no meaningful differences in the psychosocial parameters in subjects with or without irritable bowel , and those who had cholecystectomy for stones or functional gallbladder disease .


Those declining randomization were comparable to those randomized .


Psychosocial comorbidity in SOD is high .


However , it does not appear to differ significantly from that reported in surveys of age - and gender-matched general populations , and may be lower than reported with other FGIDs .


Neonatal sepsis is a major cause of neonatal mortality .


In populations with limited access to health care , early identification of bacterial infections and initiation of antibiotics by community health workers ( CHWs ) could be lifesaving .


It is unknown whether this strategy would be feasible using traditional birth attendants ( TBAs ) , a cadre of CHWs who typically have limited training and educational backgrounds .


We analyzed data from the intervention arm of a cluster-randomized trial involving TBAs in Lufwanyama District , Zambia , from June 2006 to November 2008 .


TBAs followed neonates for signs of potential infection through 28 days of life .


If any of 16 criteria were met , TBAs administered oral amoxicillin and facilitated referral to a rural health center .


Our analysis included 1,889 neonates with final vital status by day 28 .


TBAs conducted a median of 2 ( interquartile range 2-6 ) home visits ( 51.4 % in week 1 and 48.2 % in weeks 2-4 ) and referred 208 neonates ( 11 % ) for suspected sepsis .


Of referred neonates , 176/208 ( 84.6 % ) completed their referral .


Among neonates given amoxicillin , 171/183 ( 93.4 % ) were referred ; among referred neonates , 171/208 ( 82.2 % ) received amoxicillin .


Referral and/or initiation of antibiotics were strongly associated with neonatal death ( for referral , relative risk [ RR ] = 7.93 , 95 % confidence interval [ CI ] = 4.4-14 .3 ; for amoxicillin administration , RR = 4.7 , 95 % CI = 2.4-8 .7 ) .


Neonates clinically judged to be `` extremely sick '' by the referring TBA were at greatest risk of death ( RR = 8.61 , 95 % CI = 4.0-18 .5 ) .


The strategy of administering a first dose of antibiotics and referring based solely on the clinical evaluation of a TBA is feasible and could be effective in reducing neonatal mortality in remote rural settings .


Two major antigenically heterogenous norovirus genogroups ( GI and GII ) commonly infect humans and are the leading cause of foodborne , viral gastrointestinal infections in adults .


We assessed B cell responses in participants in a double-blind , placebo-controlled , dose-escalation phase 1 study of the safety and immunogenicity of an intramuscular bivalent norovirus virus-like particle ( VLP ) vaccine .


The vaccine contained a GI .1 VLP ( Norwalk ) and a consensus GII .4 VLP , representing the two major genotypes that cause human disease , and was administered on days 0 and 28 to healthy adults aged 18-49 years .


Four separate cohorts received increasing doses of 5 g , 15 g , 50 g , and 150 g of each VLP adjuvanted in monophosphoryl lipid A and alum .


PBMCs were analyzed for B cell activation and mucosal homing markers ( flow cytometry ) and VLP-specific and total IgG and IgA Ab-secreting cells ( ASCs ) ; and serum titers of VLP-specific IgG , IgA , and Pan-Ig were determined .


The vaccine elicited CD27 + CD38 + plasmablasts and high frequencies of ASCs specific for both VLP antigens in the peripheral blood at 7 days after the first dose .


The plasmablasts exhibited a mucosal-homing phenotype and included a high proportion of IgA ASCs .


Serum antibodies increased as early as 7 days after the first immunization .


The data suggest that a single dose of the IM bivalent norovirus vaccine is effective in activating pre-existing B cell memory .


The rapid B cell response and the mucosal homing phenotype of induced ASCs are consistent with anamnestic responses in subjects primed by prior oral norovirus infection .


This study is registered at ClinicalTrials.gov Identifier NCT01609257 .


The study aimed to compare the efficacy and safety of nebulized steroid ( NS ) with systemic corticosteroids ( SC ) and to determine optimal NS dose in the treatment of patients with COPD exacerbations requiring hospitalization .


The study was a randomized , parallel design trial .


Eligible patients ( n = 86 ) were randomly allocated to 1 of the 3 treatment groups : parenteral corticosteroid ( PS ) ( n = 33 ) , 4 mg ( NB ) ( n = 27 ) , or 8 mg NB ( n = 26 ) .


Partial pressure of arterial oxygen ( PaO2 ) , carbon dioxide ( PaCO2 ) , pH , and oxygen saturation ( SaO2 ) were evaluated at baseline , 24 h , 48 h , and discharge .


Airway obstruction ( forced vital capacity [ FVC ] and forced expiratory volume 1 s [ FEV1 ] ) was evaluated at admission and discharge .


There were no significant differences between the groups for all parameters at all time periods , except for higher FEV1 value in the 8-mg NB group at baseline .


In groups , significant differences were determined for FVC , FEV1 , PaO2 , and SaO2 ( p < 0.001 ) , but not for PaCO2 and pH , in comparison to their baseline values .


As adverse events , hyperglycemia and oral moniliasis were observed in the PS group ( n = 4 ) and in the NB groups ( n = 5 ) , respectively , and treatment change was required in 9 patients ( 2 patients in the PS group and 7 patients in the NB groups ) ( p = 0.57 ) .


Nebulized budesonide may be used as an alternative to SC because of its equal effectiveness and lesser systemic adverse effects .


The choice of optimal dosage needs to be evaluated carefully because adverse effect and dropout rates varied according to dosage .


However , there is a need for further studies including more severe cases and evaluating long-term outcomes or relapses comparing the 3 arms .


Placebo-controlled trials indicate that cytisine , a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation , almost doubles the chances of quitting at 6 months .


We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit .


We conducted a pragmatic , open-label , noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks .


Cytisine was provided by mail , free of charge , and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges .


Low-intensity , telephone-delivered behavioral support was provided to both groups through the quitline .


The primary outcome was self-reported continuous abstinence at 1 month .


At 1 month , continuous abstinence from smoking was reported for 40 % of participants receiving cytisine ( 264 of 655 ) and 31 % of participants receiving nicotine-replacement therapy ( 203 of 655 ) , for a difference of 9.3 percentage points ( 95 % confidence interval , 4.2 to 14.5 ) .


The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week , 2 months , and 6 months .


In a prespecified subgroup analysis of the primary outcome , cytisine was superior to nicotine-replacement therapy among women and noninferior among men .


Self-reported adverse events over 6 months occurred more frequently in the cytisine group ( 288 events among 204 participants ) than in the group receiving nicotine-replacement therapy ( 174 events among 134 participants ) ; adverse events were primarily nausea and vomiting and sleep disorders .


When combined with brief behavioral support , cytisine was found to be superior to nicotine-replacement therapy in helping smokers quit smoking , but it was associated with a higher frequency of self-reported adverse events .


( Funded by the Health Research Council of New Zealand ; Australian New Zealand Clinical Trials Registry number , ACTRN12610000590066 . )


Chronic hepatitis B ( CHB ) can progress to cirrhosis , hepatocellular carcinoma ( HCC ) and ultimately liver-related death .


Although oral antiviral therapy for patients with CHB reduces the risk of such complications , once cirrhosis is established , the benefits of antiviral therapy are not robustly demonstrated .


According to traditional Chinese medicine ( TCM ) , some Chinese herbal medicines promote blood circulation and soften hard masses , and therefore they may block and reverse hepatic fibrosis .


The aim of this study is to evaluate the effects of TCM tablets of the compound biejia ruangan ( RGT ) administered for fibrosis , and entecavir ( ETV ) , on the development of HCC in patients with CHB or hepatitis B virus ( HBV ) - related compensated cirrhosis .


This multicenter , centrally randomized , double-blind , placebo-controlled , parallel-group study is planned to complete within 5 years .


For the study , 1,000 with CHB or HBV-related compensated cirrhosis are randomly assigned in a 1:1 ratio to a treatment group ( 0.5 mg ETV once daily ; 2 g RGT three times daily ) or a control group ( 0.5 mg ETV once daily ; 2 g RGT dummy agent three times daily ) .


The primary end points are the development of HCC and liver-related death .


Secondary end points include disease progression and overall survival .


Although antiviral therapy can achieve sustained suppression of HBV replication , thereby preventing cirrhosis , patients with CHB treated with nucleos ( t ) ide analogs ( NUCs ) retain a higher risk for HCC compared with patients with inactive disease .


Although previous clinical trials with RGT have confirmed the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or compensated cirrhosis , the long-term risk for HCC or disease progression in these patients treated with combination of RGT and NUCs compared with NUCs alone is unclear .


Therefore , it is necessary to investigate the effects of the RGT blockade and reversal of hepatic fibrosis on the development of HCC in patients with CHB or HBV-related compensated cirrhosis in large , prospective , multicenter , double-blind , randomized , controlled trials in China .


ClinicalTrials.gov Identifier : NCT01965418 .


Date registered : 17 October 2013 .


Pain is among the most cited negative effects of orthodontic treatment .


Non-steroidal anti-inflammatory drugs seem to be an effective option for minimizing this but can have adverse effects on tooth movement owing to their ability to block prostaglandin synthesis .


Acetaminophen has been suggested as the analgesic of choice during orthodontic treatment as it showed no effect on orthodontic tooth movement in previous animal studies .


The purpose of this study was to compare the effects of ibuprofen and acetaminophen on the prostaglandin E2 ( PGE2 ) levels of the gingival crevicular fluid ( GCF ) during orthodontic tooth movement in human subjects .


A total of 42 patients ( mean age 184.5 years ) were randomly divided into three equal groups : ibuprofen , acetaminophen , and control groups .


Maxillary canines were distalized with 150 g of force delivered by NiTi coil springs .


GCF samples were obtained before ( baseline ) and after spring activation at 24 , 48 , and 168 h.


The PGE2 content of the GCF was determined using enzyme-linked immunosorbent assay .


PGE2 levels in all groups increased significantly by 24 and 48 h of force application and decreased to baseline levels by 168 h. No significant difference was found between the acetaminophen and control groups at any time point .


There was a significant decrease in PGE2 levels in the ibuprofen group at 24 and 48 h when compared to the other two groups .


Acetaminophen showed no significant effect on prostaglandin synthesis and may be the safe choice compared to ibuprofen for relieving pain associated with orthodontic tooth movement .


To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics .


Two-arm , parallel group , assessor blind , pragmatic , randomised controlled trial .


802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment .


Brief advice consisted of feedback on alcohol and health , written information and an offer of an appointment with an Alcohol Health Worker .


Control participants received a leaflet on health and lifestyle .


The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation .


The main secondary outcome was unprotected sex during this period .


Among the 402 randomised to brief advice , 397 ( 99 % ) received it .


The adjusted mean difference in alcohol consumption at 6 months was -2.33 units per week ( 95 % CI -4.69 to 0.03 , p = 0.053 ) among those in the active compared to the control arm of the trial .


Unprotected sex was reported by 154 ( 53 % ) of those who received brief advice , and 178 ( 59 % ) controls ( adjusted OR = 0.89 , 95 % CI 0.63 to 1.25 , p = 0.496 ) .


There were no significant differences in costs between study groups at 6 months .


Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources .


Current Controlled Trials ISRCTN 99963322 .


Dietary nitrate supplementation with beetroot juice ( BR ) has received widespread attention as an ergogenic aid .


However , recent evidence in well-trained cyclists has not consistently reported improved cycling economy or performance .


The present study examined the effects of acute and chronic BR supplementation on VO2 during submaximal running and 1500-m time trial ( TT ) performance of elite distance runners .


Eight male 1500-m runners ( VO2peak , 80 5 mLkgmin ; 1500-m personal best , 3:56 9 s ) participated in this study .


In a randomized , double-blind , crossover design , subjects supplemented with BR or a nitrate-free BR placebo ( PL ) for 8 d separated by at least 1 wk .


On days 1 ( acute ) and 8 ( chronic ) , subjects ingested 210 mL of BR ( 19.5-mmol nitrate ) or PL and completed a submaximal treadmill run and 1500-m TT on an indoor 200-m track .


Plasma nitrate increased from 37 15 to 615 151 M ( acute ) and 870 259 M ( chronic ) after BR supplementation .


There were no VO2 differences between conditions at 50 % , 65 % , and 80 % VO2peak ( acute PL , 4194 90 mLmin ; chronic PL , 4216 95 mLmin ; acute BR , 4192 113 mLmin ; chronic BR , 4299 92 mLmin ) .


The 1500-m TT was unaffected by acute or chronic BR supplementation ( acute PL , 4:10.4 min : s 2.5 s ; chronic PL , 4:11.4 min : s 2.7 s ; acute BR , 4:10.7 min : s 1.5 s ; chronic BR , 4:10.5 min : s 2.2 s ) .


However , two subjects improved their TT performance after acute ( 5.8 and 5.0 s ) and chronic BR supplementation ( 7.0 and 0.5 s ) .


Acute and chronic BR supplementation did not reduce running VO2 or improve 1500-m TT performance of a group of elite distance runners , but two responders to BR were identified .


To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain .


Double blind parallel group randomised controlled trial with six months ' follow-up conducted May 2011-March 2013 .


Participants , physiotherapists , assessors , and analyses were blinded to group allocation .


Interdisciplinary chronic pain centre .


135 participants with non-specific chronic low back pain > 12 weeks were recruited from 225 patients assessed for eligibility .


Participants were randomised to receive anodal ( 20 minutes to motor cortex at 2 mA ) or sham transcranial direct current stimulation ( identical electrode position , stimulator switched off after 30 seconds ) for five consecutive days immediately before cognitive behavioural management ( four week multidisciplinary programme of 80 hours ) .


Two primary outcome measures of pain intensity ( 0-100 visual analogue scale ) and disability ( Oswestry disability index ) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management .


Analyses of covariance with baseline values ( pain or disability ) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain ( difference between groups on visual analogue scale 1 mm ( 99 % confidence interval -8.69 mm to 6.3 mm ; P = 0.68 ) ) and disability ( difference between groups 1 point ( -1.73 to 1.98 ; P = 0.86 ) ) and did not influence the outcome of cognitive behavioural management ( difference between group 3 mm ( -10.32 mm to 6.73 mm ) ; P = 0.58 ; difference between groups on Oswestry disability index 0 point ( -2.45 to 2.62 ) ; P = 0.92 ) .


The stimulation was well tolerated with minimal transitory side effects .


This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain.Trial registration Current controlled trials ISRCTN89874874 .


The purposes of this study were to establish the physiological interpretation of the shape parameter of the dynamic contrast-enhanced ultrasound ( DCE-US ) lognormal perfusion model and to evaluate the clinical significance of the parameter in a sample of patients undergoing antiangiogenic therapy for metastatic renal cell carcinoma ( mRCC ) .


The physiological interpretation of the lognormal shape parameter was explored using computer simulations of disruption-replenishment in fractal models of the microcirculation generated by a piecewise iterative algorithm in MATLAB .


Architectural variety was accomplished by introducing random perturbations to the diameter , length , and branching angles to the growing vascular tree .


The shape parameter was extracted from the time-intensity curves and compared with the transit time distributions calculated directly from the simulations .


Dynamic contrast-enhanced ultrasound data were obtained from 31 consenting patients with mRCC being treated with antiangiogenic therapy .


Lognormal parameters related to the blood volume , mean flow speed , and vascular morphology/heterogeneity extracted before , during , and after therapy were correlated with progression-free survival ( PFS ) .


Cox proportional hazard ratios were calculated alongside receiver operator characteristics for different combinations of the vascular parameters to determine their ability to distinguish patients who would progress early ( less than the median PFS ) versus late ( greater than the median PFS ) .


The lognormal shape parameter correlated strongly to the width of the transit time distribution calculated directly from the simulations , and by extension , to the morphology/heterogeneity of the microvascular network ( Spearman r = 0.80 , P < 0.001 , n = 28 ) .


Shorter time to progression was predicted by higher baseline heterogeneity ( P = 0.003 ) and a reduction in tumor blood volume less than 43 % ( P = 0.002 ) after 2 weeks of treatment .


Combining baseline parameters with changes that occur shortly after starting treatment increased the sensitivity and specificity of DCE-US to identify which patients would progress/resist therapy early versus late compared with when the vascular parameters were considered in isolation .


The DCE-US shape parameter from the lognormal perfusion model is representative of microvascular morphology/heterogeneity and may be used to noninvasively characterize the vascular architecture of cancer lesions .


A more abnormal flow distribution at baseline predicts for poorer outcome for patients treated with antiangiogenic therapy for metastatic renal cell cancer .


Combining pretreatment and on-treatment measurements of vascularity can improve the performance of DCE-US to predict which patients will progress earlier versus later when on antiangiogenic therapy for mRCC .


There is considerable interindividual variability in pulmonary artery pressure among high-altitude ( HA ) dwellers , but the underlying mechanism is not known .


At low altitude , a patent foramen ovale ( PFO ) is present in about 25 % of the general population .


Its prevalence is increased in clinical conditions associated with pulmonary hypertension and arterial hypoxemia , and it is thought to aggravate these problems .


We searched for a PFO ( transesophageal echocardiography ) in healthy HA dwellers ( n = 22 ) and patients with chronic mountain sickness ( n = 35 ) at 3,600 m above sea level and studied its effects ( transthoracic echocardiography ) on right ventricular ( RV ) function , pulmonary artery pressure , and vascular resistance at rest and during mild exercise ( 50 W ) , an intervention designed to further increase pulmonary artery pressure .


The prevalence of PFO ( 32 % ) was similar to that reported in low-altitude populations and was not different in participants with and without chronic mountain sickness .


Its presence was associated with RV enlargement at rest and an exaggerated increase in right-ventricular-to-right-atrial pressure gradient ( 25 7 mm Hg vs 15 9 mm Hg , P < .001 ) and a blunted increase in fractional area change of the right ventricle ( 3 % [ -1 % , 5 % ] vs 7 % [ 3 % , 16 % ] , P = .008 ) during mild exercise .


These findings show , we believe for the first time , that although the prevalence of PFO is not increased in HA dwellers , its presence appears to facilitate pulmonary vasoconstriction and RV dysfunction during a mild physical effort frequently associated with daily activity .


ClinicalTrials.gov ; No. : NCT01182792 ; URL : www.clinicaltrials.gov .


In most ocular procedures , a central position of the eye is necessary .


This can be achieved using a deep plane of anaesthesia , locoregional blocks or with neuromuscular blocking agents .


The aim of this study was to evaluate the influence of atracurium on cardiovascular parameters , and on recovery quality and duration in horses .


Thirty-four warmblood horses undergoing in total 50 vitrectomies were divided into two groups .


Premedication , induction and maintenance were identical in all patients .


After 20 minutes , horses of group A received atracurium ( 0.1 mg/kg ) while in the control group ( group K ) the depth of anaesthesia was adapted to keep the bulbus in a central position .


Dobutamine and fluids were administered to maintain the mean arterial blood pressure ( MAP ) above 70 mmHg .


Cardiac output ( CO ) , heart rate ( HR ) , MAP , respiratory rate , end-expiratory isoflurane concentration ( ETIso ) and dobutamine requirements were determined .


Position and movement of the globe during the surgical procedure were scored .


Time and quality of the recovery period was scored .


Horses of group K required significantly higher concentrations of isoflurane ( group A : 1.08 0.1 % ; group K : 1.34 0.2 % ) and had an overall lower MAP ( group A : 88.4 10.3 mmHg ; group K : 76.6 11.6 mmHg ) and CO ( group A : 36.9 11.7 l/min ; group K : 28.5 7.2 l/min ) but needed significantly more dobutamine ( group A : 0.37 0.17 g/kg/min ; group K : 0.99 0.46 g/kg/min ) compared to group A. Complete relaxation occurred 9.5 2.5 minutes after atracurium bolus and lasted for 25 7.1 minutes .


The score of the bulbus position and movement was significantly lower in group A , resulting in a better quality for the surgical procedure .


In group A , the recovery time to standing was significantly shorter ( group A : 18.1 5.4 min ; group K : 31.5 7.1 min ) , with no difference in quality .


The use of atracurium resulted in a better cardiovascular condition , probably because of the isoflurane-sparing effect .


The recovery time was shorter in these horses without negative effects on recovery quality .


No signs of residual atracurium effects were detected .


The present study was aimed at determining the role warm saline rinse in the prevention of alveolar osteitis following dental extractions .


Apparently patients aged 16 and above who were referred to the Oral Surgery Clinic of our institution , with an indication for non-surgical extraction of pathologic teeth were prospectively and uniformly randomized into warm saline group and control .


The experimental group ( n = 80 ) were instructed to gargle 6 times daily with warm saline and no such instructions were given to the second group ( n = 80 ) to serve as controls .


Information on demographic , indications for extraction , and development of alveolar osteitis were obtained and analyzed .


Comparative statistics were done using Pearson 's chi square or Fisher 's exact test as appropriate .


A p value of less than 0.05 was considered significant .


The demographic and other baseline parameters such as indications for extractions were comparable among the study groups ( p > 0.05 ) .


The overall prevalence of alveolar osteitis was 13.7 % .


There was a statistical significant difference between the study groups with respect to development of alveolar osteitis ( X2 = 15.00 , df = 1 , p = 0.001 ) .


The risk of development of alveolar osteitis was 4 times higher in the control group ( OR = 4.33 , P = 0.001 ) .


Warm saline mouth rinse instruction is beneficial in the prevention of development of alveolar osteitis after dental extractions .


To evaluate the growth of geographic atrophy ( GA ) during anti-vascular endothelial growth factor ( VEGF ) therapy .


Cohort within a clinical trial .


Patients included in the Comparison of Age-related Macular Degeneration Treatments Trials ( CATT ) .


Participants were randomly assigned to injections of ranibizumab or bevacizumab and to a 2-year dosing regimen of monthly or pro re nata ( PRN ) or to monthly for 1 year and PRN the following year .


Digital color photographs and fluorescein angiograms at baseline and 1 and 2 years were evaluated for GA , and the total area of GA was measured by 2 graders masked to treatment ; differences were adjudicated .


Multivariate linear mixed models of the annual change in the square root of the area included baseline demographic , treatment , and ocular characteristics on imaging as candidate risk factors .


Geographic atrophy growth rate .


Among 1185 participants , 86 ( 7.3 % ) had GA at baseline , 120 ( 10.1 % ) developed GA during year 1 , and 36 ( 3.0 % ) developed GA during year 2 .


Among 194 eyes evaluable for growth , the rate was 0.43 mm/yr ( standard error [ SE ] , 0.03 mm/year ) .


In multivariate analysis , the growth rate was 0.37 mm/year in eyes receiving bevacizumab and 0.49 mm/year in eyes receiving ranibizumab ( difference , 0.11 mm/yr ; 95 % confidence interval [ CI ] , 0.01-0 .22 ; P = 0.03 ) .


Growth rate did not differ between eyes treated monthly and PRN ( P = 0.85 ) .


Eyes with subfoveal choroidal neovascularization ( CNV ) lesions had a lower growth rate than eyes with nonsubfoveal CNV lesions ( difference , 0.12 ; 95 % CI , 0.01-0 .22 ; P = 0.03 ) .


Eyes with GA farther from the fovea had higher growth rates by 0.14 ( 95 % CI , 0.01-27 ) mm/year for every millimeter farther from the fovea .


The growth rate was 0.58 mm/year for eyes with predominantly classic lesions , 0.41 mm/year for eyes with minimally classic lesions , and 0.30 mm/year for eyes with occult only lesions ( P < 0.01 ) .


The growth rate in eyes having a fellow eye with GA was higher by 0.13 mm/year ( 95 % CI , 0.01-0 .24 ; P = 0.03 ) than in eyes without GA in the fellow eye .


Eyes with epiretinal membrane had a higher growth rate than eyes without epiretinal membrane ( difference , 0.16 ; 95 % CI , 0.03-0 .30 ; P = 0.02 ) .


Geographic atrophy growth depends on several ocular factors .


Ranibizumab may accelerate GA growth .


Intravenous ( IV ) acetaminophen may be an effective component of multimodal postoperative pain management .


The primary objective of this study was to evaluate the impact of IV acetaminophen on total opioid use in postoperative patients .


The secondary objective was to evaluate the effect of IV acetaminophen on hospital length of stay .


This retrospective , case-control study evaluated the impact of IV acetaminophen on total opioid use in surgical patients .


Patients were included if they received at least one perioperative dose of IV acetaminophen and underwent a surgical knee procedure .


Controls were matched and randomly selected based on procedure type , age , and severity of illness .


Postoperative opioids were converted into oral morphine equivalents , and overall use was compared between groups .


One hundred patients were enrolled , with 25 patients receiving IV acetaminophen and 75 matched controls .


A total of 135mg versus 112.5 mg oral morphine equivalents were used in the IV acetaminophen group and control group , respectively ( p = 0.987 ) .


There were 45mg/day oral morphine equivalents used in the IV acetaminophen group versus 37.5 mg in the control group ( p = 0.845 ) .


The median hospital length of stay in both groups was 3days ( p = 0.799 ) .


IV acetaminophen did not significantly decrease postoperative opioid use in patients who underwent surgical knee procedures .


In addition , there was a nonsignificant trend toward increased opioid use in the IV acetaminophen group .


There was no significant difference in hospital length of stay between the IV acetaminophen group and the control group .


These findings require further study in larger patient populations and in other orthopedic procedures that typically require longer hospital stays .


To determine if repetitive sphenopalatine ganglion ( SPG ) blocks with 0.5 % bupivacaine delivered through the Tx360 ( ) are superior in reducing pain associated with chronic migraine ( CM ) compared with saline .


The SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa ( PPF ) in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve .


From an anatomical and physiological perspective , SPG blockade may be an effective acute and preventative treatment for CM .


This was a double-blind , parallel-arm , placebo-controlled , randomized pilot study using a novel intervention for acute treatment in CM .


Up to 41 subjects could be enrolled at 2 headache specialty clinics in the US .


Eligible subjects were between 18 and 80 years of age and had a history of CM defined by the second edition of the International Classification of Headache Disorders appendix definition .


They were allowed a stable dose of migraine preventive medications that was maintained throughout the study .


Following a 28-day baseline period , subjects were randomized by computer-generated lists of 2:1 to receive 0.5 % bupivacaine or saline , respectively .


The primary end-point was to compare numeric rating scale scores at pretreatment baseline vs 15 minutes , 30 minutes , and 24 hours postprocedure for all 12 treatments .


SPG blockade was accomplished with the Tx360 ( ) , which allows a small flexible soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa into the intranasal space .


A 0.3 cc of anesthetic or saline was injected into the mucosa covering the SPG .


The procedure is performed similarly in each nostril .


The active phase of the study consisted of a series of 12 SPG blocks with 0.3 cc of 0.5 % bupivacaine or saline provided 2 times per week for 6 weeks .


Subjects were re-evaluated at 1 and 6 months postfinal procedure .


The final dataset included 38 subjects , 26 in the bupivacaine group and 12 in the saline group .


A repeated measures analysis of variance showed that subjects receiving treatment with bupivacaine experienced a significant reduction in the numeric rating scale scores compared with those receiving saline at baseline ( M = 3.78 vs M = 3.18 , P = .10 ) , 15 minutes ( M = 3.51 vs M = 2.53 , P < .001 ) , 30 minutes ( M = 3.45 vs M = 2.41 , P < .001 ) , and 24 hours after treatment ( M = 4.20 vs M = 2.85 , P < .001 ) , respectively .


Headache Impact Test-6 scores were statistically significantly decreased in subjects receiving treatments with bupivacaine from before treatment to the final treatment ( Mdiff = -4.52 , P = .005 ) , whereas no significant change was seen in the saline group ( Mdiff = -1.50 , P = .13 ) .


SPG blockade with bupivacaine delivered repetitively for 6 weeks with the Tx360 ( ) device demonstrates promise as an acute treatment of headache in some subjects with CM .


Statistically significant headache relief is noted at 15 and 30 minutes and sustained at 24 hours for SPG blockade with bupivacaine vs saline .


The Tx360 ( ) device was simple to use and not associated with any significant or lasting adverse events .


Further research on sphenopalatine ganglion blockade is warranted .


The aim of this study was to investigate the efficacy of a single shot intercostal block for pain control in pediatric patients undergoing the Nuss procedure .


A double-blind , randomized , controlled study was performed .


Thirty patients received a single shot bilateral intercostal block with levobupivacaine ( L group ) and 30 patients with 0.9 % saline ( S group ) .


Standardized baseline analgesia was applied for all patients .


Morphine consumption , pain scores , respiratory depression , nausea and vomiting , and urinary retention were recorded every 3h for 48h after surgery .


The loading dose of morphine was lower ( p < 0.00001 ) in the L group .


There were significantly lower morphine doses up to 6h after surgery and VAS scores up to 3h after surgery in the L group ( p < 0.001 and p = 0.0003 , respectively ) .


The incidence of nausea and vomiting was lower in the L group ( < 0.00001 ) .


The incidence of urinary retention was lower in the L group ( p = 0.019 ) .


A single shot IB is an effective additional treatment for pediatric patients undergoing the Nuss procedure and results in the reduced consumption of morphine , less postoperative pain , and fewer opioid-related adverse effects .


To evaluate a slower ( compared with a standard ) infusion rate of the loading dose of magnesium sulphate for preterm fetal neuroprotection as a strategy to reduce maternal adverse effects .


Randomised controlled trial .


South Australian maternity hospital .


Fifty-one women at < 30 weeks of gestation , where birth was planned or expected within 24 hours .


Women received a loading infusion of 4 g of magnesium sulphate over either 60 or 20 minutes ( followed by maintenance of 1 g/hour until birth , or for up to 24 hours ) .


Any maternal adverse effects associated with the infusion .


Overall , 71 % of women experienced adverse effects during the first hour of their infusion ; the difference between groups was not significant [ 15/25 ( 60 % ) 60-minute loading ; 21/26 ( 81 % ) 20-minute loading ; risk ratio ( RR ) 0.74 ; 95 % confidence interval ( 95 % CI ) 0.51-1 .08 ] .


Although no serious maternal complications occurred , adverse effects led to three women ceasing the loading treatment ( 1/25 in the 60-minute loading group ; 2/26 in the 20-minute loading group ; RR 0.52 ; 95 % CI 0.05-5 .38 ) .


Women in the 60-minute loading group experienced significantly less warmth and flushing at 20 minutes into the infusion ( 7/25 in the 60-minute loading group ; 15/26 in the 20-minute loading group ; RR 0.49 ; 95 % CI 0.24-0 .99 ) .


No other differences between groups for maternally reported and clinical adverse effects were shown .


A slower rate of administering the loading dose of magnesium sulphate did not reduce the occurrence of maternal adverse effects overall .


Flushing and warmth at 20 minutes into the infusion was reduced with a slower infusion .


To determine whether sugar-free gum can provide remineralization and caries control of active enamel caries lesions compared to baseline ( before gum chewing ) and to a no-gum group , following daily chewing for 12 weeks by school children ; to determine whether chewing frequency can affect the extent of remineralization .


A pragmatic cluster-randomized controlled clinical trial with schools as the unit of randomization was employed .


Three schools in Chengdu , PR China comprised the clusters .


The study was approved by the Internal Review Board of Sichuan University .


177 school children , 8-13 years old , with at least one visible white-spot lesion were enrolled in the study .


Each of the three clusters was randomly assigned to one of three groups : ( 1 ) no gum ; ( 2 ) chew 2 pieces of sugar-free gum for 20 minutes , 3x per day ; ( 3 ) chew 2 pieces of sugar-free gum for 12 minutes , 5x per day .


White-spot lesions were examined by quantitative light-induced fluorescence ( QLF ) at baseline and after 4 , 8 , and 12 weeks of treatment .


155 subjects completed the study .


Of them , the mean values of fluorescence loss at baseline were 9.52 , 9.83 and 9.17 for no-gum group , 3x per day group and 5x per day group , respectively .


For the area , the mean values at baseline were 2.52 , 2.61 and 2.57 mm2 for no-gum group , 3x per day group and 5x per day group , respectively .


For AQ , the mean values at baseline were -27.91 , -28.29 and -29.67 for no-gum group , 3x per day group and 5x per day group , respectively .


To adjust for differences in groups at baseline , ANCOVA was used .


After 12-weeks , for all QLF metrics , the absolute values of 5x per day group were the lowest and the no gum group was the highest ; the differences among three groups were statistically significant ( P < 0.05 ) .


For AQ , which was accepted as the most useful metrics of QLF system , the adjusted mean values at 12 weeks were -26.35 , -19.81 and -17.58 for no-gum group , 3x per day group and 5x per day group , respectively .


There were significant differences between groups .


The primary goal of fluid therapy is to maintain fluid homeostasis .


Commonly used isotonic crystalloids are only marginally effective and contribute to fluid excess syndrome .


In patients with decreased cardiovascular reserve , fluid therapy alone is not sufficient to maintain end-organ perfusion .


Therefore , inotropes or vasoactive drugs are used to supplement fluid infusion .


Recent animal data suggest that coinfusion of adrenergic agents modulate the distribution of fluid between the vascular and extravascular/interstitial compartments after a fluid bolus .


We sought to determine if this effect would translate in humans by coadministering a - adrenergic agonist with fluid .


Nine healthy volunteers ( aged 21-50 years ) were randomly paired and received either a continuous isoproterenol infusion ( ISO : 0.05 g/kg per minute ) or 0.9 % saline ( control [ CON ] ) 30min prior to a 25 mL/kg 0.9 % NaCl fluid bolus .


Hemodynamics , ventricular volume and function , and microcirculatory determinants ( capillary filtration coefficient and oncotic pressure ) were measured .


Vascular and extravascular volume and fluid balance were determined .


Compared with CON , ISO significantly increased heart rate ( CON : 64.2 4.1 beats/min vs. ISO : 97.4 5.7 beats/min ) and cardiac output ( CON : 4.4 0.7 L/min vs. ISO : 10.2 0.9 ) before fluid bolus .


Isoproterenol significantly increased urinary output ( ISO : 10.86 1.95 vs. control : 6.53 1.45 mL/kg ) and reduced extravascular volume ( 7.98 2.0 vs. 14.15 1.1 mL/kg ) .


Isoproterenol prevented an increase in capillary filtration coefficient ( 1.74 0.4 vs. 3.21 0.4 mL/min per mmHg 10 ) .


Isoproterenol , a nonselective - adrenergic agonist , augments vascular volume expansion and eliminates extravascular volume via enhanced diuresis , which may in part be due to enhanced endothelial barrier function .


To assess the need for surgical treatment in patients with acute abdominal pain in a prospective randomized study .


Initially 203 patients with acute abdominal pain were randomized to the routine abdominal computed tomography CT ( rCT , n = 118 ) , or selective abdominal CT group ( sCT , n = 85 ) over a period of 16 months .


Ninety-three of the randomized patients ( 45.8 % ) underwent the study design and were reached for follow-up at three months .


Diagnostic accuracy improved significantly in the rCT group ( p < 0.001 ) .


The surgeon 's assessment of the need for surgery changed more often in the rCT group than in the sCT group ( 78.7 % vs. 46.9 % , p = 0.002 ) .


The confidence to treat operatively increased significantly in the rCT vs. the sCT group ( 65.6 % vs. 40.6 % , p = 0.028 ) .


The rCT was the only independent parameter for the change of the assessment of surgery .


Routine CT allows for more confidence in decision making for the surgical treatment of patients with acute abdominal pain .


Hand-held NB-UVB units are lightweight devices that may overcome the need to treat vitiligo in hospital-based phototherapy cabinets , allowing early treatment at home that may enhance the likelihood of successful repigmentation .


The pilot Hi-Light trial examined the feasibility of conducting a large multi-centre randomised controlled trial ( RCT ) on the use of such devices by exploring recruitment , adherence , acceptability , and patient education .


This was a feasibility , double-blind , multi-centre , parallel group randomised placebo-controlled trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home .


The overall duration of the trial was seven months ; three months recruitment and four months treatment .


Participants were randomly allocated to active or placebo groups ( 2:1 ratio ) .


The primary outcome measure was the proportion of eligible participants who were willing to be randomised .


The secondary outcomes included proportion of participants expressing interest in the trial and fulfilling eligibility criteria , withdrawal rates and missing data , proportion of participants adhering to and satisfied with the treatment , and incidence of NB-UVB short-term adverse events .


Eighty-three percent ( 45/54 ) of vitiligo patients who expressed interest in the trial were willing to be randomised .


Due to time and financial constraints , only 29/45 potential participants were booked to attend a baseline hospital visit .


All 29 ( 100 % ) potential participants were confirmed as being eligible and were subsequently randomised .


Willingness to participate in the study for General Practice ( family physicians ) surgeries and hospitals were 40 % and 79 % , respectively ; 86 % ( 25/29 ) of patients adhered to the treatment and 65 % ( 7/11 ) of patients in the active group had some degree of repigmentation .


Only one patient in the active group reported erythema grade 3 ( 3 % ) .


Both devices ( Dermfix 1000 NB-UVB and Waldmann NB-UVB 109 ) were acceptable to participants .


Hand-held NB-UVB devices need evaluation in a large , pragmatic RCT .


This pilot trial has explored many of the uncertainties that need to be overcome before embarking on a full scale trial , including the development of a comprehensive training package and treatment protocol .


The study has shown strong willingness of participants to be randomised , very good treatment adherence and repigmentation rates , and provided evidence of feasibility for a definitive trial .


NCT01478945 .


Aerobic fitness is an important predictor of postoperative outcome in major surgery .


In this study , we assess the effects of a period of preoperative exercise on aerobic fitness as measured by cardiopulmonary exercise testing ( CPET ) in patients scheduled for abdominal aortic aneurysm ( AAA ) repair .


As part of a randomized trial , the first patients recruited in the intervention group were enrolled in a supervised exercise program of six week duration .


Treadmill CPET parameters were measured before and after exercise preoperatively for these patients .


These parameters were as follows : peak oxygen uptake ( VO2 peak ) , anaerobic threshold ( AT ) , and ventilator equivalents for oxygen and carbon dioxide ( VE/VO2 and VE/VCO2 , respectively ) .


Total exercise time and the time at which AT was achieved were also recorded .


A comparison between pre - and postexercise parameters was made to detect for a possible improvement in aerobic fitness .


Twenty patients with AAA ( 17 men ; mean age : 74.9 5.9 years ) were included in this study .


Thirty-five percent of patients had a history of ischemic heart disease , 25 % of obstructive airway disease , and 15 % of cerebral vascular events .


Seventy percent were previous smokers , and 15 % were current smokers .


Fifty-five percent of patients were taking aspirin and 75 % were undergoing statin therapy .


The median ( interquartile range ) VO2 peak at baseline was 18.2 ( 15.4-19 .9 ) mL/kg/min , and after exercise was 19.9 ( 17.1-21 .1 ; P = 0.048 ) .


Median AT at baseline was 12.2 ( 10.5-14 .9 ) , and 14.4 ( 12.3-15 .4 ) after exercise ( P = 0.023 ) .


Time of exercise tolerated also improved from a median of 379to 604sec ( P = 0.001 ) .


No significant changes were seen in VE/VO2 , VE/VCO2 , or the time at which AT was achieved .


This study shows that cardiopulmonary aerobic fitness improves after a period of supervised exercise in patients scheduled for AAA repair .


This is justification for a randomized trial to assess whether this affects morbidity and mortality after AAA repair .


Natalizumab inhibits the migration of systemic immune cells to the CNS and may be beneficial in progressive multiple sclerosis ( MS ) .


The objective of the study was to examine the effects of natalizumab in progressive MS.


In an open-label phase 2A study , 24 patients with progressive MS were included to receive natalizumab treatment for 60 weeks .


Response to natalizumab was assessed in CSF and MRI studies .


The primary endpoint was change in CSF osteopontin , a biomarker of intrathecal inflammation , from baseline to week 60 .


Seventeen patients completed the study .


No new safety issues were encountered .


CSF osteopontin decreased by 65 ng/mL ( 95 % confidence interval 34-96 ng/mL ; p = 0.0004 ) from baseline to week 60 in conjunction with decreases in other CSF biomarkers of inflammation , axonal damage , and demyelination .


Magnetization transfer ratio increased in both cortical gray and normal-appearing white matter and correlated with decreases in CSF neurofilament light chain .


Natalizumab treatment of progressive MS reduces intrathecal inflammation and tissue damage , supporting a beneficial effect of natalizumab treatment in progressive MS and suggesting that systemic inflammation contributes to the pathogenesis .


Moreover , the study establishes the feasibility of using CSF biomarkers in proof-of-concept trials , allowing a low number of participants and short study duration .


This study provides Class IV evidence that in patients with progressive MS , natalizumab reduces biomarkers of intrathecal inflammation .


Despite evidence that erythropoietin and intra - and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands , Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion .


To actually change physicians ' practice , a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed .


The study aims to examine the effectiveness , feasibility and costs of this tailored de-implementation strategy compared to a control strategy .


A cluster randomized controlled trial including an effect , process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals .


Randomisation takes place at hospital level .


The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components : interactive education , feedback in educational outreach visits , electronically sent reports on hospital performance ( all aimed at orthopedic surgeons and anesthesiologists ) , and information letters or emails aimed at other involved professionals within the intervention hospital ( transfusion committee , OR-personnel , pharmacists ) .


The hospitals in the control group will receive a control strategy ( i.e. , passive dissemination of available evidence ) .


Outcomes will be measured at patient level , using retrospective medical record review .


This will be done in all hospitals at baseline and after completion of the intervention period .


The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied .


The actual exposure to the tailored strategy and users ' experiences will be assessed in the process evaluation .


In the economic evaluation , the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared .


This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy .


This knowledge can be used in national and international initiatives to make healthcare more efficient .


It also provides more generalized knowledge regarding de-implementation strategies .


This trial is registered at the Dutch Trial Register NTR4044 .


The first studies comparing covered stents ( CS ) and bare stents ( BS ) to achieve Transjugular Intrahepatic Portosystemic Shunt ( TIPS ) were in favor of CS , but only one randomized study has been performed .


Our aim was to compare the primary patency of TIPS performed with CS and BS .


The study was planned as a multicenter , pragmatic ( with centers different in size and experience ) , randomized , single-blinded ( with blinding of patients only ) , parallel group trial .


The primary endpoint was TIPS dysfunction defined as either a portocaval gradient 12mmHg , or a stent lumen stenosis 50 % .


A transjugular angiography with portosystemic pressure gradient measurement was scheduled every 6months after TIPS insertion .


137 patients were randomized : 66 to receive CS , and 71 BS .


Patients who were found to have a hepato-cellular carcinoma , or whose procedure was cancelled were excluded , giving a sample of 129 patients ( 62 vs. 67 ) .


Median follow-up for CS and BS were 23.6 and 21.8 months , respectively .


Compared to BS , the risk of TIPS dysfunction with CS was 0.60 95 % CI [ 0.38-0 .96 ] , ( p = 0.032 ) .


The 2-year rate of shunt dysfunction was 44.0 % for CS vs. 63.6 % for BS .


Early post TIPS complications ( 22.4 % vs. 34.9 % ) , risk of hepatic encephalopathy ( 0.89 [ 0.53-1 .49 ] ) and 2-year survival ( 70 % vs. 67.5 % ) did not differ in the two groups .


The 2-year cost/patient was 20k [ 15.9-27 .5 ] for CS vs. 23.4 k [ 18-37 ] for BS ( p = 0.52 ) .


CS provided a significant 39 % reduction in dysfunction compared to BS .


We did not observe any significant difference with regard to hepatic encephalopathy or death .


This study aims to compare the effect of three CPR prompt and feedback devices on quality of chest compressions amongst healthcare providers .


A single blinded , randomised controlled trial compared a pressure sensor/metronome device ( CPREzy ) , an accelerometer device ( Phillips Q-CPR ) and simple metronome on the quality of chest compressions on a manikin by trained rescuers .


The primary outcome was compression depth .


Secondary outcomes were compression rate , proportion of chest compressions with inadequate depth , incomplete release and user satisfaction .


The pressure sensor device improved compression depth ( 37.24-43 .64 mm , p = 0.02 ) , the accelerometer device decreased chest compression depth ( 37.38-33 .19 mm , p = 0.04 ) whilst the metronome had no effect ( 39.88 mm vs. 40.64 mm , p = 0.802 ) .


Compression rate fell with all devices ( pressure sensor device 114.68-98 .84 min ( -1 ) , p = 0.001 , accelerometer 112.04-102 .92 min ( -1 ) , p = 0.072 and metronome 108.24 min ( -1 ) vs. 99.36 min ( -1 ) , p = 0.009 ) .


The pressure sensor feedback device reduced the proportion of compressions with inadequate depth ( 0.52 vs. 0.24 , p = 0.013 ) whilst the accelerometer device and metronome did not have a statistically significant effect .


Incomplete release of compressions was common , but unaffected by the CPR feedback devices .


Users preferred the accelerometer and metronome devices over the pressure sensor device .


A post hoc study showed that de-activating the voice prompt on the accelerometer device prevented the deterioration in compression quality seen in the main study .


CPR feedback devices vary in their ability to improve performance .


In this study the pressure sensor device improved compression depth , whilst the accelerometer device reduced it and metronome had no effect .


Dialectical behavior therapy ( DBT ) is an empirically supported treatment for suicidal individuals .


However , DBT consists of multiple components , including individual therapy , skills training , telephone coaching , and a therapist consultation team , and little is known about which components are needed to achieve positive outcomes .


To evaluate the importance of the skills training component of DBT by comparing skills training plus case management ( DBT-S ) , DBT individual therapy plus activities group ( DBT-I ) , and standard DBT which includes skills training and individual therapy .


We performed a single-blind randomized clinical trial from April 24 , 2004 , through January 26 , 2010 , involving 1 year of treatment and 1 year of follow-up .


Participants included 99 women ( mean age , 30.3 years ; 69 [ 71 % ] white ) with borderline personality disorder who had at least 2 suicide attempts and/or nonsuicidal self-injury ( NSSI ) acts in the last 5 years , an NSSI act or suicide attempt in the 8 weeks before screening , and a suicide attempt in the past year .


We used an adaptive randomization procedure to assign participants to each condition .


Treatment was delivered from June 3 , 2004 , through September 29 , 2008 , in a university-affiliated clinic and community settings by therapists or case managers .


Outcomes were evaluated quarterly by blinded assessors .


We hypothesized that standard DBT would outperform DBT-S and DBT-I .


The study compared standard DBT , DBT-S , and DBT-I .


Treatment dose was controlled across conditions , and all treatment providers used the DBT suicide risk assessment and management protocol .


Frequency and severity of suicide attempts and NSSI episodes .


All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts , suicide ideation , use of crisis services due to suicidality , and reasons for living .


Compared with the DBT-I group , interventions that included skills training resulted in greater improvements in the frequency of NSSI acts ( F1 ,85 = 59.1 [ P < .001 ] for standard DBT and F1 ,85 = 56.3 [ P < .001 ] for DBT-S ) and depression ( t399 = 1.8 [ P = .03 ] for standard DBT and t399 = 2.9 [ P = .004 ] for DBT-S ) during the treatment year .


In addition , anxiety significantly improved during the treatment year in standard DBT ( t94 = -3.5 [ P < .001 ] ) and DBT-S ( t94 = -2.6 [ P = .01 ] ) , but not in DBT-I .


Compared with the DBT-I group , the standard DBT group had lower dropout rates from treatment ( 8 patients [ 24 % ] vs 16 patients [ 48 % ] [ P = .04 ] ) , and patients were less likely to use crisis services in follow-up ( ED visits , 1 [ 3 % ] vs 3 [ 13 % ] [ P = .02 ] ; psychiatric hospitalizations , 1 [ 3 % ] vs 3 [ 13 % ] [ P = .03 ] ) .


A variety of DBT interventions with therapists trained in the DBT suicide risk assessment and management protocol are effective for reducing suicide attempts and NSSI episodes .


Interventions that include DBT skills training are more effective than DBT without skills training , and standard DBT may be superior in some areas .


clinicaltrials.gov Identifier : NCT00183651 .


To compare the effectiveness of two dosing regimens of vaginal misoprostol for cervical ripening and induction of labour .


Pregnant women with singleton low risk pregnancy at term scheduled for elective induction of labour were randomized to receive either 25 g or 50 g of vaginal misoprostol for pre-labour cervical ripening .


All the patients received antenatal care and delivered at the University College Hospital ( UCH ) from January 1 st to May 31 st 2006 .


A total of 128 patients were randomized ; 65 patients received 25 g and 63 patients received 50 g of vaginal misoprostol .


Significantly higher number of patients in the 50 g group progressed to active labour as compared with the 25 g group ( 95.2 % versus 84.6 % , P < 0.05 ) .


The need for oxytocin augmentation of labour was higher among the 25 g as compared with 50 g ( 39.7 % versus 16.4 % , P = 0.007 ) .


There was higher proportion of patients in the 50 g group delivering vaginally within 24 hours as compared with the 25 g group ( 98.2 % versus 90.0 % , P = 0.063 ) .


However , the mean interval between the first dose of misoprostol and vaginal delivery was not statistically different in the two groups ( 754 362 minutes and 885 582 minutes , P = 0.152 ) .


The incidence of caesarean section was similar in the two groups ( 7.7 % versus 11 % , P = 0.580 ) .


Labour complications , such as precipitate labour , tachysystole and abnormal fetal heart rate patterns were greater in the 50 g group .


Twenty-five microgram of misoprostol appears to be as effective as 50 g for pre-induction cervical ripening and labour induction .


Though 50 g of vaginal misoprostol resulted in relatively faster delivery and less need for oxytocin augmentation , it was associated with more labour complications as compared with 25 g of misoprostol .


To determine whether day 3 FSH and E2 levels at the upper limits of normal affect live-birth rates and treatment trajectory in a conventional versus `` fast track '' treatment program for IVF .


Secondary analysis of two randomized controlled trials , FASTT and FORT-T .


Not applicable .


Infertile women ages 21-42 years randomized to conventional or accelerated treatment with controlled ovarian hyperstimulation ( COH ) - IUI and/or IVF ( n = 603 patients contributing 2,717 total cycles ) .


Patients were stratified according to basal FSH and E2 : FSH < 10 mIU/mL and E2 < 40 pg/mL ( group 1A ) , FSH < 10 mIU/mL and E240 pg/mL ( group 1B ) , FSH , 10-15 mIU/mL and E2 < 40 pg/mL ( group 2A ) , and FSH , 10-15 mIU/mL and E240 pg/mL ( group 2B ) .


Number of cancelled cycles , disenrollment for poor response , and cumulative live-birth rates per couple .


Women in groups 2A and 2B were more likely to have cancelled cycles and be disenrolled for poor response .


While no live births occurred in group 2B during COH-IUI ( 0/19 couples , 0/58 cycles ) , IVF still afforded these patients a reasonable chance of success ( 6/18 couples , 6/40 cycles , 33.3 % live-birth rate per couple ) .


The specificity and positive predictive value of basal FSH of 10-15 mIU/mL and E240 pg/mL for no live birth during COH-IUI treatment were both 100 % .


Women who initiated infertility treatment with FSH of 10-15 mIU/mL and E240 pg/mL on day 3 testing were unlikely to achieve live birth after COH-IUI treatment .


Stratified medicine aims to improve clinical and cost-effectiveness by identifying moderators of treatment that indicate differential response to treatment .


Cognitive behavioural therapy ( CBT ) is often offered as a ` next-step ' for patients who have not responded to antidepressants , but no research has examined moderators of response to CBT in this population .


We aimed , therefore , to identify moderators of response to CBT in treatment resistant depression .


We used linear regression to test for interactions between treatment effect and 14 putative moderator variables using data from the CoBalT randomised controlled trial .


This trial examined the effectiveness of CBT given in addition to usual care ( n = 234 ) compared with usual care alone ( n = 235 ) for primary care patients with treatment resistant depression .


Age was the only variable with evidence for effect modification ( p Value for interaction term = 0.012 ) , with older patients benefiting the most from CBT .


We found no evidence of effect modification by any other demographic , life , illness , personality trait , or cognitive variable ( p0 .2 ) .


Given the largely null findings , a stratified approach that might limit offering CBT is premature ; CBT should be offered to all individuals where antidepressant medication has failed .


To determine the effectiveness of a non-return catheter valve vs. the standard urine bag for prevention of catheter-associated urinary tract infections ( CAUTI ) in critically ill patients .


This was a pilot , randomized , stratified , open-label controlled trial ( ClinicalTrials.gov , number NCT01963013 ) .


Ninety-six critically illpatients requiring indwelling urinary catheter were assigned with either a non-return catheter valve or the standard urine bag .


Symptoms and signs of CAUTI before and after enrollment for all patients were recorded .


If CAUTI was suspected , urine for microbiological testing was collected The primary outcome was the incidence density rate of symptomatic CAUTI and bacteriurial presence .


The 96 patients were randomized into two groups .


Baseline patient characteristics were similar in both groups except for the sex distribution .


The incidence rate ratio was 0.71 for symptomatic CAUTI in the non-return catheter valve group ( 95 % CI 0.25-1 .98 , p-value = 0.51 ) .


The crude incidence rate ratio of bacteriuria in the non-return valve group was 0.66 ( 95 % CI 0.3-1 .46 , p-value = 0.31 ) .


The sex-adjusted incidence rate ratio of bacteriuria in the non-return catheter valve group was 0.64 ( 95 % CI 0.29-1 .41 , p-value = 0.27 ) .


Using a non-return catheter valve might not prevent CA UTI among critically ill patients .


There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears .


We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed .


A single-center , pragmatic , randomized controlled study with follow-ups after six months and one , two , and five years was conducted in a secondary-care institution .


One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair ( n = 52 ) or physiotherapy ( n = 51 ) .


The primary outcome measure was the Constant score .


Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score ; the physical component summary measure of the Short Form 36 Health Survey ; the measurement of pain , strength , and shoulder motion ; patient satisfaction ; and findings from magnetic resonance imaging and sonography .


Analysis was by intention to treat .


The five-year follow-up rate was 98 % .


Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair .


The results from primary tendon repair were superior to those from physiotherapy plus secondary repair , with between-group mean differences of 5.3 points on the Constant score ( p = 0.05 ) , 9.0 points on the American Shoulder and Elbow Surgeons score ( p < 0.001 ) , 1.1 cm on a 10-cm visual analog scale for pain ( p < 0.001 ) , and 1.0 cm on a 10-cm visual analog scale for patient satisfaction ( p = 0.03 ) .


In 37 % of tears treated with physiotherapy only , there were increasing tear sizes on ultrasound of > 5 mm , over five years , associated with an inferior outcome .


Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment , the differences were small and may be below clinical importance .


In the physiotherapy treatment group , there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair .


The aim of the present study was to evaluate the efficacy of misoprostol administered sublingually , vaginally or rectally on cervical ripening before hysterescopic surgery in post-menopausal women .


Post-menopausal women were randomised to receive either 400 ug of misoprostol , administered sublingually , vaginally or rectally six hours and 12 hours prior to operative hysterescopy .


Patients were randomized to receive receive sublingual ( n = 30 ) , rectal ( n = 30 ) or vaginal ( n = 30 ) misoprostol .


The control group did not receive misoprostol ( n = 30 ) .


The four groups were comparable in terms of preoperative cervical width after misoprostol administration .


The mean cervical widths for control group was 9.0 + / - 1.1 mm and the mean post-treatment cervical widths for the sublingual , vaginal , and rectal groups were 7.1 + / - 1.1 mm , 8.9 + / - 1.3 mm , and 8.6 + / - 1.5 mm , respectively .


The cervical widths of sublingual group were significantly different from control , vaginal ; and rectal groups ( p < 0.001 ) .


Four hundred micrograms of sublingual misoprostol , 12 and six hours prior to operative hysteroscopy has a significant cervical ripening effect compared with vaginal , rectal , and control groups in post-menopausal women .


Calcium ( Ca ) and iron ( Fe ) are essential minerals for normal growth and development .


Although previous studies have shown that Ca inhibits acute Fe absorption , there is no evidence of the possible long - or medium-term effects of Ca supplementation on Fe bioavailability .


The aim of this study was to determine the effect of 34 d of Ca supplementation on heme Fe and non-heme Fe bioavailability in non-pregnant women of ages 33 to 47 y.


This was a prospective , randomized , double-blind , placebo-controlled trial .


Twenty-six healthy women ( 40 5 y ) were randomly assigned to receive either 600 mg of elemental Ca/d as CaCO3 ( Ca group , n = 13 ) or a placebo ( P group , n = 13 ) for 34 d. Heme Fe and non-heme Fe bioavailability were determined before and after treatment using ( 55 ) Fe and ( 59 ) Fe radioisotopes .


A two-factor , repeated-measures analysis of variance was used to assess differences by treatment and timing .


The geometric mean ( range 1 SD ) of heme Fe bioavailability before and after treatment was 16.5 % ( 8.3-32 .8 ) and 26 % ( 15.5-43 .6 ) for the Ca group and 21.8 % ( 13.0-36 .6 ) and 25.1 % ( 16.5-38 .3 ) for the P group .


Non-heme Fe bioavailability before and after treatment was 39.5 % ( 19.9-78 .7 ) and 34.1 % ( 19.1-60 .6 ) for the Ca group , and 44.6 % ( 24.9-79 .7 ) and 39.3 % ( 24.3-63 .4 ) for the P group .


There were no differences in either heme Fe or non-heme Fe bioavailability either at baseline or after treatment .


The administration of calcium supplements for 34 d does not affect iron bioavailability .


This trial is registered with Controlled-trials .


gov , number ISRCTN 89888123 .


Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy , caesarean section , appendectomy , and trauma to the lower quadrant of the abdomen or inguinal region .


This study was designed to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia .


Randomized , double-blind controlled trial .


Hospital outpatient setting .


Twenty-one patients were allocated into 2 groups .


Group 1 received 2 cycles of pulsed radiofrequency ( PRF ) for each nerve root .


In Group 2 , after stimulation , we spent the same time to mimic PRF .


Both groups received bupivacaine 0.25 % + ' 4 mg dexamethasone in 2 mL for each nerve root .


Visual Analogue Scale ( VAS ) was assessed .


Duration of the first block effective pain relief was reported .


Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period .


The number and duration of blocks were reported and adverse effects were also reported .


Significantly longer duration of pain relief was noticed in Group 1 ( P = 0.005 ) after the first block , while the durations of pain relief of the second block were comparable ( P = 0.59 ) .


In Group 1 the second PRF produced pain relief from the twenty-fourth week until the tenth month while in Group 2 , pain relief was reported from the sixteenth week until the eighth month after the use of PRF .


All patients in Group 2 received 3 blocks ( the first was a sham PRF ) during the one year follow-up period .


Meanwhile , 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block .


No adverse events were reported .


Small sample size .


For intractable chronic inguinal pain , PRF for the dorsal root ganglion represents a promising treatment modality .


Impulsivity and individual differences in subjective response to alcohol are risk factors for alcohol problems and possibly endophenotypes for alcohol dependence .


Few prior studies have addressed relationships between the two constructs .


To predict subjective responses to ethanol , we tested self-reported impulsiveness , ethanol dose condition ( high dose , low dose , or placebo ) , and time ( seven time points ) along with interactions among these variables .


The present study is a secondary analysis of data from a within-subject , placebo-controlled , dose-ranging ethanol administration study using IV infusion with a clamping technique to maintain steady-state breath alcohol concentration .


The sample consisted of healthy , non-alcohol dependent social alcohol drinkers between the ages of 21 and 30 ( N = 105 ) .


Participants at varying levels of impulsivity were compared with regard to stimulant and subjective responses to three ethanol dose conditions over time .


Individuals with higher impulsivity reported elavated stimulant and dampened sedative response to alcohol , particularly at the higher dose .


Higher impulsivity was associated with a steeper increase in stimulant effects during the first half of clamped ethanol infusion with the higher dose .


These results suggest that impulsive individuals may experience enhanced reinforcing , stimulant effects , and relatively muted aversive sedative effects from alcohol .


These subjective responses may relate to enhanced risk of alcohol problems among more impulsive individuals .


Kangaroo care ( KC ) has possible benefits for promoting physiological stability and positive developmental outcomes in preterm infants .


The purpose of this study was to compare bradycardia and oxygen desaturation events in preterm infants in standard incubator care versus KC .


Thirty-eight infants 27 to 30 weeks gestational age were randomly assigned to 2 hours of KC daily between days of life 5 to 10 or to standard incubator care .


Infants were monitored for bradycardia ( heart rate < 80 ) or oxygen desaturation ( < 80 % ) .


Analysis of hourly events was based on three sets of data : standard care group 24 hours daily , KC group during incubator time 22 hours daily , and KC group during holding time 2 hours daily .


The KC group had fewer bradycardia events per hour while being held compared to time spent in an incubator ( p = 0.048 ) .


The KC group also had significantly fewer oxygen desaturation events while being held than while in the incubator ( p = 0.017 ) and significantly fewer desaturation events than infants in standard care ( p = 0.02 ) .


KC reduces bradycardia and oxygen desaturation events in preterm infants , providing physiological stability and possible benefits for neurodevelopmental outcomes .


Several studies have demonstrated that soluble receptor of advanced glycation end-products ( sRAGE ) is a valuable inflammatory biomarker in cardiovascular disease ( CVD ) .


Remote ischaemic conditioning may rescue myocardial tissue during acute myocardial infarction ( AMI ) .


In the present study , we evaluate whether sRAGE is a helpful biomarker in patients with AMI receiving remote ischaemic conditioning .


Plasma sRAGE levels were measured in 191 patients with ST-elevation myocardial infarction ( STEMI ) treated with primary percutaneous intervention ( pPCI ) of which 97 patients were randomised to receive remote ischaemic conditioning .


The sRAGE levels were not different when compared to the randomised controls .


In 122 patients , measurement of myocardial salvage index ( SI ) was obtained .


Patients who received remote ischaemic conditioning had significantly higher SI compared to the controls ( p < 0.03 ) , although this effect was not seen in sRAGE concentrations .


However , sRAGE levels increased with higher New York Heart Association ( NYHA ) classification after 30 days of follow-up .


sRAGE levels do not reflect increased SI in AMI patients who received remote ischaemic conditioning prior to hospital admission .


Primary objective of this study was to compare the efficacy of Prasugrel vs. Clopidogrel in the patients with acute coronary syndromes ( ACS ) undergoing percutaneous coronary intervention ( PCI ) by measuring inhibition of platelet aggregation after loading and maintenance dose of both the drugs .


The patients were also assessed for safety of the drugs .


This was a randomised , double-blind , double-dummy , comparative , multicentric clinical trial in patients with acute coronary syndrome ( unstable angina , non-ST elevation MI and ST elevation MI ) undergoing PCI .


The patients were randomly assigned to receive prasugrel ( loading dose of 60 mg followed by maintenance dose of 10-mg once daily ) or clopidogrel ( loading dose of 300 mg followed by maintenance dose of 75 mg once daily ) for a period of 12 weeks .


All the patients were co-prescribed aspirin 325 mg with both the drugs .


The primary efficacy end point in this study was percentage inhibition of ADP induced platelet aggregation ( IPA ) at 4 + / - 1 hours after the loading dose and at 30 + / - 3 days during maintenance treatment .


The platelet aggregation of both the drugs was measured by whole blood aggregometer using 10 mmol of ADP as an aggregant .


Though this study was not powered to see the difference in clinical efficacy parameters , the patients were observed for the incidence of nonfatal MI , nonfatal stroke , re-hospitalization , death , or need for urgent revascularization due to a cardiac ischemic event at days 30 and 90 during the study .


The safety of study drugs were evaluated by incidence of major bleeding , reported adverse drug reaction and alterations of any laboratory parameters .


A total of 220 patients were enrolled at 11 centres across India .


Ten patients were given the loading dose of prasugrel or clopidogrel but did not underwent PCI due to change in investigator 's decision to go for PCI .


Out of 210 eligible patients , 21 patients were discontinued during the study .


157 patients were evaluated for platelet inhibition after loading dose at 4 hours and 150 patients at day 30 during maintenance phase of antiplalelet therapy .


The investigators could not perform this test in remaining patients due to urgency and criticality of the patients .


189 patients were observed for the incidence of nonfatal MI , nonfatal stroke , rehospitalisation , urgent revascularisation or death due to a cardiac ischemic event .


All eligible patients who received at least a loading dose were evalauted for safety .


In prasugrel group , 85 and 77 patients were evaluated for IPA at 4 hours and day 30 respectively whereas in clopdogrel group 72 and 73 patients were tested for IPA at 4 hours and at 30 days .


Patients in prasugrel group have demonstrated significantly higher inhibition of platelets as compared to clopidogrel group ( 82.5 % vs 71.1 % ) at 4 hours and at 30 days ( 84.1 % vs 67.4 % ) .


The difference in inhibition of platelets between prasugrel and clopidogrel after loading dose and maintenenace dose was statistically significant ( p < or = 0.01 ) .


The patients were also evaluated for drug hyporesponsiveness to antiplatelet therapy if IPA was < 20 % at day 30 from the baseline .


More patients on prasugrel have shown response to antiplatlet therapy than on clopidogrel ( 97.4 % vs 87.6 % ) .


The difference between the two groups was statistically significant ( p < 0.05 ) .


There was no difference observed during the study in the incidence of nonfatal MI , nonfatal stroke , death , rehospitalisation or need for urgent revascularisation due to a cardiac event between prasugrel and clopidogrel .


Both the drugs were found to be to be well tolerated and have comparable safety profile .


This study suggests that prasugrel is more effective than clopidogrel as an anti platelet drug as evident by inhibition of platelet aggregation .


More patients on clopidogrel are likely to have poor response to therapy as compared to prasugrel .


Both the drugs were well tolerated and have comparable safety profile .


The objective of this prospective , multicenter , randomized trial was to evaluate and compare 1-year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery ( FESS ) .


Adults with maxillary chronic rhinosinusitis ( CRS ) , including those with anterior ethmoid disease , who failed medical management and were surgical candidates for FESS , underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year .


Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test ( SNOT-20 ) survey .


Standardized effect sizes were computed to further assess clinical significance .


Ostial patency rate , rhinosinusitis episode frequency , impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey , complications , and revision rate were also compared between the two groups .


Ninety-two patients ( 50 balloon dilation ; 42 FESS ) were treated and 89 ( 96.7 % ) completed 1-year follow-up .


Both groups showed clinically meaningful and statistically significant ( p < 0.0001 ) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales .


The 1-year mean change in SNOT-20 after balloon dilation ( -1.64 ) was noninferior to FESS ( -1.65 ; p < 0.001 ) .


The standardized effect size was large , showing clinically significant improvement for both interventions .


Ostial patency was 96.7 and 98.7 % after balloon dilation and FESS , respectively , and each group reported significant reductions ( p < 0.0001 ) in rhinosinusitis episodes ( mean decrease , 4.2 for balloon dilation and 3.5 for FESS ) .


Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved ( p < 0.001 ) in both groups .


There were no complications and revision surgery rate was 2 % in each arm through 1 year .


With 1-year follow-up , standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS .


The fixed-dose combination of any two antihypertensive drugs from different drug classes is typically more effective in reducing blood pressure than a dose increase of component monotherapy .


We assessed the efficacy and safety of a fixed-dose combination of a vasodilating blocker ( nebivolol ) and an angiotensin II receptor blocker ( valsartan ) in adults with hypertension .


We did an 8-week , phase 3 , multicentre , randomised , double-blind , placebo-controlled , parallel-group trial at 401 US sites .


Participants ( age 18 years ) with hypertension but with blood pressure less than 180/110 mm Hg were randomly assigned ( 2:2:2:2:2:2:2:1 ) by a 24-h interactive web response system in blocks of 15 to 4 weeks of double-blind treatment with nebivolol and valsartan fixed-dose combination ( 5 and 80 mg/day , 5 and 160 mg/day , or 10 and 160 mg/day ) , nebivolol ( 5 mg/day or 20 mg/day ) , valsartan ( 80 mg/day or 160 mg/day ) , or placebo .


Doses were doubled in weeks 5-8 ; results are reported according to the final dose .


Participants and research staff were masked to treatment allocation .


The primary and key secondary endpoints were changes from baseline to week 8 in diastolic and systolic blood pressure , respectively .


The primary statistical comparison was between the highest fixed-dose combination dose and the highest monotherapy doses ; lower doses were then compared if this comparison was positive ( Hochberg method for multiple testing ) .


Efficacy analyses were by intention to treat .


Safety assessments included monitoring of adverse events .


Continuous efficacy parameters were analysed using an ANCOVA model ; binary outcomes were analysed using a logistic regression model .


This study is registered with ClinicalTrials.gov , NCT01508026 .


Between Jan 6 , 2012 , and March 15 , 2013 , 4161 patients were randomly assigned ( 277 to placebo and 554-555 to each active comparator group ) , 4118 of whom were included in the primary analysis .


At week 8 , the fixed-dose combination 20 and 320 mg/day group had significantly greater reductions in diastolic blood pressure from baseline than both nebivolol 40 mg/day ( least-squares mean difference -12 mm Hg , 95 % CI -23 to -01 ; p = 0030 ) and valsartan 320 mg/day ( -44 mm Hg , -54 to -33 ; p < 00001 ) ; all other comparisons were also significant , favouring the fixed-dose combinations ( all p < 00001 ) .


All systolic blood pressure comparisons were also significant ( all p < 001 ) .


At least one treatment-emergent adverse event was experienced by 30-36 % of participants in each group .


Nebivolol and valsartan fixed-dose combination is an effective and well-tolerated treatment option for patients with hypertension .


Forest Research Institute .


Haemorrhage is the most common major complication of endoscopic sinus surgery .


Post-operative absorbable or non-absorbable nasal packing can cause pain and blockage .


Haemostatic powders or gels may prevent this problem .


However , when based on factors in the clotting cascade , they induce an inflammatory reaction and can cause post-operative synechiae .


Oxidised cellulose powder produces haemostasis without inducing synechiae formation , but has not been trialled for sinus surgery .


A randomised clinical trial was performed to compare cellulose powder to non-absorbable packing following sinus surgery .


Participants were 50 consecutive patients undergoing sinus surgery , 47 of whom completed the study .


The main outcome measures were post-operative bleeding , pain scores and synechiae formation .


Cellulose powder was effective at stopping bleeding , and was associated with less pain than nasal packing , with no evidence of increased synechiae formation .


Cellulose powder appears to be a good haemostatic agent following sinus surgery .


A larger trial would allow more accurate quantification of its effectiveness .


Pain caused by intravenous injection of the muscle relaxant rocuronium bromide is common in children and adolescents .


The cause of this unwanted effect is still unclear , and different pretreatment drugs have been administered in attempts to alleviate this side effect , with varying degrees of success .