Group A ( @ patients ) was fixed with @ bioabsorbable Rigidfix pins , @ cross-pin per bundle , while group B ( @ patients ) was secured with @ EndoButton cortical button per bundle .


All femoral tunnels were created via an anteromedial portal , and a bioabsorbable Biointrafix interference screw was used for tibial fixation for both groups .


The evaluation of the patients was performed by history details , clinical examination findings , measurement of the joint laxity by KT-@ arthrometer , and use of validated patient outcome questionnaires .


Statistical analysis was carried out with Fisher exact and Mann-Whitney U tests , with P < @ considered the cutoff level of significance .


At a mean follow-up of @ months , @ and @ patients of group A and B , respectively , were available for evaluation .


There were no statistically significant differences between the treatment groups regarding the subjective and objective outcomes , except for KT-@ arthrometer values .


The median KT-@ value of patients in the cross-pin fixation group was @ mm , while the median value in the cortical button fixation group was @ mm ( P < @ ) .


Four patients with ACL grafts that were fixed with cortical buttons demonstrated failure of stability via the instrumented knee laxity testing , while patients from the other group had no failures .


Intratunnel femoral fixation of the double-bundle ACL graft from the cross-pin fixation technique provided better instrumented knee laxity results than did the extratunnel femoral fixation with cortical buttons .


Future larger studies comparing these @ techniques should be conducted to ensure the availability of stronger evidence supporting the findings of this study .


To compare results of obese patients with knee osteoarthritis ( OA ) who , after an intensive weight loss regimen , received @ year of either dietary support ( D ) , a knee-exercise program ( E ) , or `` no attention '' ( C ; control group ) .


We conducted a randomized , @-phase , parallel-group trial .


A total of @ obese participants with knee OA were enrolled ; the mean age was @ years and @ % were women with a mean entry weight of @ kg .


In phase @ , all participants were randomly assigned to @ of @ groups and began a dietary regimen of @-@ and @,@ kcal/day for @ weeks ( @ @-week phases ) to achieve a major weight loss .


Phase @ consisted of @ weeks ' maintenance in either group D , E , or C. Outcomes were changes from randomization in pain on a @-mm visual analog scale , weight , and response according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria .


Mean weight loss for phase @ was @ kg .


After @ year on maintenance therapy , the D group sustained a lower weight ( @ kg , @ % confidence interval -LSB- @ % CI -RSB- @ , @ kg ) than those in the E ( @ , @ % CI @ , @ kg ) and C ( @ , @ % CI @ , @ kg ) groups ( P = @ by analysis of covariance -LSB- ANCOVA -RSB- ) .


Adherence was low in the E group .


All groups had statistically significant pain reduction ( D : @ ; E : @ ; and C : @ mm ) with no difference between groups ( P = @ by ANCOVA ) .


In each group @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) participants responded to treatment in the D , E , and C groups , respectively , with no statistically significant difference in the number of responders ( P = @ ) .


A significant weight reduction with a @-year maintenance program improves knee OA symptoms irrespective of maintenance program .


Perampanel , a selective , noncompetitive - amino-@-hydroxy-@-methyl-@-isoxazolepropionic acid ( AMPA ) glutamate receptor antagonist , is indicated for adjunctive treatment of partial seizures in patients @years based on three phase III clinical studies .


The perampanel U.S. Prescribing Information includes a boxed warning for serious psychiatric and behavioral adverse reactions .


To provide context for this warning , detail on psychiatric and behavioral safety data from perampanel clinical studies is presented .


An analysis of pooled safety data from three phase III studies in patients with partial seizures is presented .


Data from phase I and phase II studies in patients with and without epilepsy were also analyzed .


Psychiatric and behavioral treatment-emergent adverse events ( TEAEs ) were evaluated according to Medical Dictionary for Regulatory Activities ( MedDRA ) terms , using `` narrow '' and `` narrow-and-broad '' standardized MedDRA queries ( SMQs ) for TEAEs suggestive of hostility/aggression .


From the three phase III partial-seizure studies , the overall rate of psychiatric TEAEs was higher in the @mg ( @ % ) and @mg ( @ % ) perampanel groups versus placebo ( @ % ) .


In the `` narrow '' SMQ , hostility/aggression TEAEs were observed in @ % for @mg and @ % for @mg perampanel groups , versus @ % of placebo patients .


`` Narrow-and-broad '' SMQs for hostility/aggression TEAE rates were @ % for @mg and @ % for @mg perampanel groups , versus @ % for placebo ; rates for events resulting in discontinuation were perampanel = @ % versus placebo = @ % .


For events reported as serious AEs ( SAEs ) , rates were perampanel = @ % versus placebo = @ % .


In nonepilepsy patients , psychiatric TEAEs were similar between patients receiving perampanel and placebo .


In phase I subjects/volunteers , all psychiatric TEAEs were mild or moderate .


These analyses suggest that psychiatric adverse effects are associated with use of perampanel .


Patients and caregivers should be counseled regarding the potential risk of psychiatric and behavioral events with perampanel in patients with partial seizures ; patients should be monitored for these events during treatment , especially during titration and at higher doses .


Less than @ % of patients experience sufficient pain relief with current drug therapy for neuropathic pain .


Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain .


In this randomized , double-blind , placebo-controlled clinical trial , patients with subacute lumbar radicular pain received placebo , amitriptyline @ mg , or minocycline @ mg once a day ( n = @ per group ) for @ days .


Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from @ to @ on days @ and @ .


Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire , consumption of rescue medication , and adverse events on days @ and @ .


Sixty patients were randomized and included in an intention-to-treat analysis .


After @ days , patients in the minocycline and amitriptyline groups reported a reduction of @ ( @ % confidence interval , @-@ @ ; P = @ ) and @ ( @ % confidence interval , @-@ @ ; P = @ ) , respectively , in the numeric rating scale compared to the placebo group .


No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups .


The rate of adverse events in the amitriptyline group was @ % versus none in the minocycline and placebo groups .


No differences were noted in the consumption of rescue medication .


Although both groups differed from placebo , their effect size was small and therefore not likely to be clinically meaningful .


This study investigated the role of the bone marrow-derived CD@ + cell in a milieu of osteoprogenitor cells , bone marrow plasma cell adhesion molecules , recombinant human bone morphogenetic protein ( rhBMP ) , and a matrix of crushed cancellous allogeneic bone in the clinical regeneration of functionally useful bone in craniomandibular reconstructions .


The history and current concepts of bone marrow hematopoietic stem cells and mesenchymal stem cells are reviewed as they relate to bone regeneration in large continuity defects of the mandible .


Patients with @ - to @-cm continuity defects of the mandible with retained proximal and distal segments were randomized into two groups .


Group A received an in situ tissue-engineered graft containing @ @ CD@ + cells/mL along with @ @ CD@ + , CD@ + , and CD@ + cells/mL together with rhBMP-@ in an absorbable collagen sponge ( @ mg/cm of defect ) and crushed cancellous allogeneic bone .


Group B received the same graft , except the CD@ + cell concentration was @,@ @ cells/mL .


The results were analyzed clinically , radiographic bone density was measured in Hounsfield units ( HU ) , and specimens were analyzed histomorphometrically .


Forty patients participated ( @ men and @ women ; mean age , @ years ) .


Eight of @ group A patients ( @ % ) achieved the primary endpoint of mature bone regeneration , whereas all @ group B patients ( @ % ) achieved the primary endpoint .


CD@ + cell counts above @/mL were associated with achievement of the primary endpoint .


Bone density was lower in group A ( @ @ HU ) than in group B ( @ @ HU ) .


Group A bone showed a mean trabecular bone area of @ % @ % , versus @ % @ % for group B.


The CD@ + cell functions as a central signaling cell to mesenchymal stem cells and osteoprogenitor cells in bone regeneration .


The mechanism of bone marrow-supported grafts requires a complete milieu to regenerate large quantities of functionally useful bone .


CD@ + cell counts in a concentration of at least @/mL in composite grafts are directly correlated to clinically successful bone regeneration .


To determine the effect of nutritional supplementation on height , weight , and body mass index ( BMI ) in short and lean prepubertal children .


A prospective , randomized , double-blinded , placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy , lean , short , prepubertal children @-@-years-old .


Anthropometry measurements were measured at @ months .


Two hundred participants ( @ boys ) entered the study and @ ( @ % ) completed the intervention period .


Baseline characteristics including age , sex , height-SDS , weight-SDS , BMI-SDS , and dietary caloric and protein intakes were similar in the formula and placebo groups .


` Good ' consumers ( intake of @ % of the recommended dose ) in the formula group significantly improved height-SDS ( P < @ ) and weight-SDS ( P = @ ) with no change in BMI-SDS compared with ` poor ' consumers and the placebo group .


In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS ( r = @ , P < @ ) and weight-SDS ( r = @ , P = @ ) ; no significant correlations were found in the placebo group .


No serious adverse events were reported during the study .


Nutritional intervention with the formula was found to be a feasible , effective , and safe approach for promoting the physical growth of short and lean prepubertal children .


Methylated catechin , one of the active ingredients in green tea , has been reported to ameliorate allergic reactions .


We evaluated the efficacy of ` Benifuuki ' green tea , which contains O-methylated epigallocatechin-@-O - -LSB- @-O-methyl -RSB- gallate ( O-methylated EGCG ) , in alleviating Japanese cedar pollinosis ( JCP ) .


The study was a double-blind , randomized , placebo-controlled trial .


The subjects with JCP were randomly assigned to drink @ml of ` Benifuuki ' green tea containing O-methylated EGCG or ` Yabukita ' green tea ( not containing O-methylated EGCG ) as a placebo every day from December @ through March @ , which includes the pollen season .


The primary outcome was the area under the curve ( AUC ) of symptom scores during the peak pollen season .


Fifty-one adults with JCP participated in the study .


Twenty-six subjects were assigned to ` Benifuuki ' and @ to ` Yabukita ' .


The AUC of symptom score during the peak pollen season in the ` Benifuuki ' group was significantly smaller than in the ` Yabukita ' group for each of runny nose , itchy eyes , tearing , total nasal symptom score , total ocular symptom score , nasal symptom-medication score and ocular symptom-medication score .


The total QOL-related questionnaire score for one week in the peak pollen season was significantly better in the ` Benifuuki ' group .


Increase in the peripheral eosinophil count in response to pollen exposure was suppressed in the ` Benifuuki ' group .


No adverse events were reported in either group .


` Benifuuki ' green tea containing a large amount of O-methylated EGCG reduced the symptoms of JCP and has potential as a complementary/alternative medicine for treating seasonal allergic rhinitis .


To observe the analgesic effect and safety of acupuncture-anesthetic composite anesthesia ( AACA ) in hysteroscopic surgery .


Totally @ patients undergoing hysteroscopic surgery were randomly assigned to the intravenous anesthesia group ( A group , @ cases ) , the AACA group ( B group , @ cases ) , and the acupuncture combined with intravenous anesthesia group ( C group , @ cases ) .


Patients in Group A were anesthetized by sufentanil combined propofol .


Those in Group B were anesthetized by sufentanil combined acupuncture .


Those in Group C were anesthetized by sufentanil , propofol combined acupuncture .


Yinlian and Ququan ( LR@ ) were needled for patients in Group B and C.


The peri-operative mean arterial pressure ( MAP ) , heart rate ( HR ) , and oxygen saturation ( SpO@ ) , the surgical time , the recovery time , the sufentanil and propofol dosages , adverse anesthesia reactions were observed .


Meanwhile , the OAA/S score , Ramsay sedation score , and Visual Analogue Score ( VAS ) were also measured .


Compared with Group A and C , patients in Group B were awake , with obvious increased OAA/S score ( P < @ ) .


Ramsay sedation score was significantly lower ( P < @ ) .


The MAP and HR were elevated ( P < @ ) .


The patient case of SpO@ less than @ % during the operation decreased ( P < @ ) .


The incidence of postoperative dizziness was reduced ( P < @ ) .


Compared with Group A , the propofol consumption decreased in Group C ( P < @ ) .


There was no statistical difference in the operation time , the sufentanil dosage , VAS score , the incidence of postoperative nause - a and vomiting among the three groups ( P > @ ) .


The patients were awake in AACA .


The intraoperative sedation was better than that obtained by intravenous anesthesia .


But the analgesic effect was similar to that obtained by intravenous anesthesia .


Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead .


However , dementia remains underdetected and suboptimally managed in general practice .


Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia .


The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design , with two arms : usual/normal care control versus educational intervention .


The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year .


Case identification was a secondary outcome measure .


@ practices in South-East England participated .


A total of @,@ patients with dementia ( intervention : @ , control : @ ) had information in their medical records showing the number of reviews within @ months ( or a proportion of ) before intervention or randomization and within @ months ( or a proportion of ) after .


The mean total number of dementia management reviews after the educational intervention for people with dementia was @ ( SD @ ; minimum @ ; median @ ; maximum @ ) compared with @ ( SD @ ; minimum @ ; median @ ; maximum @ ) before intervention .


In the control group prior to randomization the mean total number of dementia management reviews was @ ( SD @ ; minimum @ ; median @ ; maximum @ ) and in the period after randomization it was @ ( SD @ ; minimum @ ; median @ ; maximum @ ) .


Case detection rates were unaffected .


The estimated incidence rate ratio for intervention versus control group was @ ( P = @ , @ % CI @ to @ ) .


The trial was timely , coinciding with financial incentives for dementia management in general practice ( through the Quality Outcomes Framework ) ; legal imperatives ( in the form of the Mental Capacity Act @ ) ; policy pressure ( The National Dementia Strategy @ ) ; and new resources ( such as dementia advisors ) that increased the salience of dementia for general practitioners .


Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices , nor did it increase case identification .


The objective of the Japan Strategic Anti-cancer Randomized Trial was to verify the efficacy of the use of ultrasonography in breast cancer screening among women aged @-@ years .


The purpose of this paper was to report the design and recruitment result of this study .


In this study of women in their @s , the participants were divided into two groups , one of which ( the intervention group ) was subjected to mammography and ultrasonography ( using a standardized ultrasonography examination ) , while the other ( the control group ) was examined with mammography , in a randomized controlled trial , with the objective of verifying the accuracy and efficacy of examinations by comparing the two groups .


The cumulative total number of participants registered in the study was @ @ ( @ @ in the intervention group and @ @ in the control group ) .


@ % of participants registered to the study were under individual randomized controlled trial , @ % were under cluster randomized controlled trial and @ % were under non-randomized controlled group .


The study was designed so that participants registered at their first examination underwent examinations by the same method for the subsequent two years .


@ % of participants scheduled for a second examination had undertaken it , while information regarding the presence of interval cancer had been obtained from a further @ % using a questionnaire .


At July @ , the status of @ % of all participants was unclear .


It was the first large-scale randomized controlled trial carried out in Japan .


The scheduled second examinations were completed at the end of fiscal @ .


Once the proportion of participants whose status is unclear has fallen to @ % , the authors plan to collate the data relating to the primary end points , and publish the results .


Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects .


The aim of this study was to develop and trial a short , simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating .


The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out .


Subjects were randomized into two treatment groups ( n = @/group ) to receive either ferrous sulphate ( @mg capsules containing @mg of iron ) or placebo , both to be taken at mealtimes twice daily during the treatment period .


Subjects completed the questionnaires daily for @days .


The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts ( i.e. nausea , vomiting , heartburn , abdominal pain , diarrhoea , and constipation ) .


Seventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group .


In the second week of the study ( i.e. wash-out ) , @ % of the participants reporting one or more symptom ( s ) were in the ferrous sulphate group .


In the first week of the study ( treatment ) the number of symptoms reported by participants in the ferrous sulphate group ( meanSEM = @ ) was significantly higher than that for participants in the placebo group ( @ ) ( p = @ ) .


In the second week of the study ( wash-out ) the number of symptoms reported by participants in the ferrous sulphate group ( @ ) appeared higher than for participants in the placebo group ( @ ) although this did not reach significance ( p = @ ) .


Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were : heartburn , abdominal pain and the presence of black stools ( all p@ @ ) .


A tool for the detection of commonly-occurring side effects should not require large study numbers to be effective .


With just @ subjects per group ( iron or placebo ) , this simple questionnaire measures gastrointestinal side-effects associated with oral iron ( ferrous sulphate ) supplementation , and would be appropriate for use in intervention studies or clinical trials .


E-health initiatives hold promise to improve shared-care models of health care .


In @-@ we developed and trialled web-based software to facilitate a randomised trial of a shared-care approach for childhood obesity involving General Practitioners ( GPs ) working with tertiary specialists .


We describe the software 's development , implementation and evaluation , and make recommendations for future e-health initiatives .


The web-based software was designed with the goals of allowing both GPs and specialists to communicate and review patient progress ; integrating with existing GP software ; and supporting GPs to deliver the structured intervention .


Specifically , we aimed to highlight the challenges inherent in this process , and report on the extent to which the software ultimately met its implementation and user aims .


The study was conducted at the Royal Children 's Hospital and @ general practices across Melbourne , Australia .


Participants comprised @ GPs delivering the shared-care intervention .


Outcomes included the following .


( @ ) GPs ' pre-specified software requirements : transcribed from two focus groups and analysed for themes using content analysis .


( @ ) Software implementation and performance based on the experience of the research team and GPs .


( @ ) GP users ' evaluation collected via questionnaire .


( @ ) Software usage collected via GP questionnaire and qualified through visual inspection of the software meta-data .


Software implementation posed difficult and at times disabling technological barriers ( e.g. out-dated hardware , poor internet connections ) .


The software 's speed and inability to seamlessly link with day-to-day software was a source of considerable frustration .


Overall , GPs rated software usability as poor , although most ( @ % ) felt that the structure and functionality of the software was useful .


Recommendations for future e-health initiatives include thorough scoping of IT systems and server speed , testing across diverse environments , automated pre-requisite checks and upgrades of processors/memory where necessary , and user-created usernames and passwords .


GPs are willing to embrace novel technologies to support their practice .


However , implementation remains challenging mainly for technical reasons , and this precludes further evaluation of potential user-specific barriers .


These findings could inform future e-health ventures into shared-care , and highlight the need for an appropriate infrastructure .


The aim of this study was to assess the efficacy of using a combination treatment approach consisting of lipid emulsion eye drops , eyelid cleansing wipes , and omega-@ vitamin supplements compared with warm compresses in improving meibomian gland functionality in patients with lipid-deficient/evaporative dry eye disease ( LDDE ) .


This single-center , open-label , investigator-masked , randomized study enrolled patients aged @ years , clinically diagnosed with LDDE defined as having @ functional meibomian glands -LSB- meibomian gland yielding liquid secretion ( MGYLS ) -RSB- and positive for dry eye symptoms at screening .


Patients were randomized to receive either the combination treatment ( lipid emulsion eye drops , omega-@ supplements , and lid hygiene with eyelid wipes ) or to apply warm , wet compresses once daily , @ minutes per day , for @ months .


Meibomian gland functionality ( number of MGYLS ; primary outcome ) and patient-reported subjective assessments ( SPEED and OSDI questionnaires ; secondary outcomes ) were evaluated .


Adverse events ( AEs ) and visual acuity were assessed as safety endpoints .


Mean patient age was @ years ( n = @ ; n = @ per group ) .


Mean SD number of MGYLS was not statistically significantly different between groups at baseline ( combination treatment , @ @ ; warm compresses , @ @ , P > @ ) , and was significantly greater with combination treatment versus warm compresses after @ months of treatment ( @ @ vs. @ @ ; P = @ ) .


Dry eye symptoms were significantly improved in both groups at all follow-up visits .


Two AEs unrelated to treatment were reported ; the BCVA was unchanged from baseline in both groups .


The combination treatment regimen resulted in significant improvement in meibomian gland functionality and dry eye symptoms .


No safety issues were observed .


Radiotherapy-induced trismus ( RTIT ) is a debilitating condition without any proven effective treatment .


This study investigates the effectiveness of prophylactic training to prevent RTIT during and up to @ months after completed RT in patients with head and neck cancer ( HNC ) , also investigating the incidence of RTIT .


Sixty-six consecutive patients from two RT clinics in Sweden were randomised into one of two groups : training with TheraBite ( ) Jaw Motion Rehabilitation System ( ) or a control group .


Maximum interincisal openings ( MIO ) were recorded at baseline and once a week during treatment , three , six and @ months after completed RT. .


Training frequency was recorded by patients in a log book .


There were no significant differences in MIO between the intervention and control groups at any of the measurement points .


Patients in both groups maintained their normal variation in MIO at @ months after completed RT. .


A small group of patients in the control group had a @ % mean decrease in MIO by week @ compared to baseline and improved their MIO by using the training programme .


There was a significant mean difference in MIO from baseline to week @ ( @ mm , p = @ ) , and month @ ( @ mm , p = @ ) , for patients receiving @D conformal radiotherapy .


There was a significant difference in MIO between patients treated with RT and concurrent chemotherapy compared to patients with RT only at @ months ( p = @ ) .


Patients with HNC undergoing high dose RT do not need to be burdened with an intense prophylactic training programme during RT and up to @ months after completed RT. .


MIO measurements during RT and up to @ months after completed RT are recommended to identify a small risk group who are an exception and may need a training programme .


This study investigated the acute hemodynamic responses to multiple sets of passive stretching exercises performed with and without the Valsalva maneuver .


Fifteen healthy men aged @ to @ years with poor flexibility performed stretching protocols comprising @ sets of maximal passive unilateral hip flexion , sustained for @ seconds with equal intervals between sets .


Protocols without and with the Valsalva maneuver were applied in a random counterbalanced order , separated by @-hour intervals .


Hemodynamic responses were measured by photoplethysmography pre-exercise , during the stretching sets , and post-exercise .


The effects of stretching sets on systolic and diastolic blood pressure were cumulative until the fourth set in protocols performed with and without the Valsalva maneuver .


The heart rate and rate pressure product increased in both protocols , but no additive effect was observed due to the number of sets .


Hemodynamic responses were always higher when stretching was performed with the Valsalva maneuver , causing an additional elevation in the rate pressure product .


Multiple sets of unilateral hip flexion stretching significantly increased blood pressure , heart rate , and rate pressure product values .


A cumulative effect of the number of sets occurred only for systolic and diastolic blood pressure , at least in the initial sets of the stretching protocols .


The performance of the Valsalva maneuver intensified all hemodynamic responses , which resulted in significant increases in cardiac work during stretching exercises .


To assess whether granulocyte colony-stimulating factor ( G-CSF ) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction ( STEMI ) and left ventricular ( LV ) dysfunction after successful reperfusion .


The STEM-AMI Trial was a prospective , placebo-controlled , multicentre study .


Sixty consecutive patients with a first anterior STEMI , who underwent primary percutaneous coronary intervention @-@ h after symptom onset , with LV ejection fraction ( LVEF ) @ % measured by echocardiography within @ h after successful revascularisation ( TIMI flow score @ ) , were randomised @:@ to G-CSF ( @ g/Kg body weight b.i.d. ) or placebo .


Clinical events and Major Adverse Cardiac and Cerebrovascular Event ( MACCE ) were monitored , and LVEF , LV end-diastolic ( LVEDV ) and end-systolic ( LVESV ) volumes , and infarct size were evaluated by MRI at the final @-year follow-up .


Fifty-four patients completed the study , of whom @ with MRI .


No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups .


The @-year infarct size was not different between groups , whereas LVEDV was significantly lower in G-CSF ( n = @ ) than in placebo ( n = @ ) patients ( @ vs @ mL , respectively ; p = @ at analysis of covariance ) .


A significant inverse correlation was detected in G-CSF patients between the number of circulating CD@ cells at @ days after reperfusion and the @-year absolute and indexed LVEDV ( = -@ , @ % CI -@ to -@ , and = -@ , -@ to -@ , respectively ) , or their change over time ( r = -@ , -@ to -@ , and r = -@ , -@ to -@ , respectively ) .


G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term .


No differences have been detected in clinical outcome .


To identify risk factors for development of hypophosphataemia in patients treated with two different intensities of continuous renal replacement therapy ( CRRT ) and to assess the independent association of hypophosphataemia with major clinical outcomes .


We performed secondary analysis of data collected from @ patients during a large , multicentre randomised controlled trial of CRRT intensity .


We allocated patients to two different intensities of CRRT ( @mL/kg/hour vs @ mL/kg/hour of effluent generation ) and obtained daily measurement of serum phosphate levels .


We obtained @ @ phosphate measurements and identified @ patients ( @ % ) with hypophosphataemia , with peak incidence on Day @ and Day @ .


With lower intensity CRRT , there were @ episodes of hypophosphataemia/@ patient days , compared with @ episodes/@ patient days with higher intensity CRRT ( P < @ ) .


On multivariable logistic regression analysis , higher intensity CRRT , female sex , higher Acute Physiology and Chronic Health Evaluation score and hypokalaemia were independently associated with an increased odds ratio ( OR ) for hypophosphataemia .


On multivariable models , hypophosphataemia was associated with better clinical outcomes , but when analysis was confined to patients alive at @ hours , hypophosphataemia was not independently associated with clinical outcomes .


Hypophosphataemia is common during CRRT and its incidence increases with greater CRRT intensity .


Hypophosphataemia is not a robust independent predictor of mortality .


Its greater incidence in the higher intensity CRRT arm of the Randomised Evaluation of Normal vs Augmented Level trial does not explain the lack of improved outcomes with such treatment .


Irritable bowel syndrome ( IBS ) is among the most common gastrointestinal disorders worldwide .


In selected patients with severe diarrhoea-predominant or mixed IBS subtypes sacral nerve stimulation ( SNS ) alleviates IBS-specific symptoms and improves quality of life .


The mode of action , however , remains unknown .


The present study aimed to evaluate the effect of SNS on small intestinal motility in IBS patients .


Twenty patients treated with SNS for severe diarrhoea-predominant or mixed IBS were included in a randomised , controlled , crossover study .


The neurostimulator was turned ON or OFF for the first one month and then to the opposite setting for the next month .


Gastrointestinal transit patterns were investigated with the Motility Tracking System-@ ( MTS-@ ) at the end of each the ON and OFF period .


Primary endpoint was change in the velocity of the magnetic pill within the small intestine .


Statistical testing was performed with Wilcoxon 's rank sum test and Fisher 's exact test .


The median velocity of the magnetic pill through the small intestine in the fasting state was not significantly different between periods with and without SNS ( Group ON-OFF : median change @ m/h ( range -@ , @ ) , Group OFF-ON : median change @ m/h ( range -@ , @ ) ) ( p = @ ) .


Neither , was the median velocity of the magnetic pill through the small intestine in the postprandial state significantly different between periods with and without SNS ( Group ON-OFF : median change -@ m/h ( range -@ , @ ) , Group OFF-ON : median change @ m/h ( range -@ , @ ) ) ( p = @ ) .


Even though SNS may reduce symptoms of diarrhoea-predominant and mixed IBS , it has no detectable effect on small intestinal transit patterns .


Fetal survival is severely compromised when the amniotic membrane ruptures between @ and @ weeks of pregnancy .


Reduced amniotic fluid levels are associated with poor lung development , whereas adequate levels lead to better perinatal outcomes .


Restoring amniotic fluid by means of ultrasound-guided amnioinfusion ( AI ) may be of benefit in improving perinatal and long-term outcomes in children of pregnancies with this condition .


The AI in preterm premature rupture of membranes ( AMIPROM ) pilot study was conducted to assess the feasibility of recruitment , the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes ( between @ and @ weeks of pregnancy ) .


It was also performed to assess outcomes and collect data to inform a larger , more definitive , clinical trial .


A prospective , non-blinded randomised controlled trial .


A computer-generated random sequence using a @ : @ ratio was used .


Randomisation was stratified for pregnancies in which the amniotic membrane ruptured between @ ( +@ ) and @ ( +@ ) weeks ' gestation and @ ( +@ ) and @ ( +@ ) weeks ' gestation .


The randomisation sequence was generated in blocks of four .


Telephone randomisation and intention-to-treat analysis were used .


Four UK hospital-based fetal medicine units - Liverpool Women 's NHS Trust , St. Mary 's Hospital , Manchester , Birmingham Women 's NHS Foundation Trust and Wirral University Hospitals Trust .


Women with confirmed preterm prelabour rupture of membranes between @ ( +@ ) and @ ( +@ ) weeks ' gestation .


Women with multiple pregnancies , resultant fetal abnormalities or obstetric indication for immediate delivery were excluded .


Participants were randomly allocated to either serial weekly transabdominal AI or expectant management ( Exp ) until @ weeks of pregnancy , if the deepest pool of amniotic fluid was < @ cm .


Short-term maternal , pregnancy and neonatal outcomes and long-term outcomes for the child were studied .


Long-term respiratory morbidity was assessed using validated respiratory questionnaires at @ , @ and @ months of age and infant lung function was assessed at approximately @ months of age .


Neurodevelopment was assessed using Bayley 's Scale of Infant Development II at a corrected age of @ years .


Fifty-eight women were randomised and two were excluded from the analysis owing to termination of pregnancy for lethal anomaly , leaving @ participants ( @ serial AI , @ Exp ) recruited between @ and @ , with annual recruitment rates varying between @ and @ .


Recruitment to the study improved significantly from @ with National Institute for Health Research ( NIHR ) funding .


There was no significant difference in perinatal mortality -LSB- @/@ vs. @/@ ; relative risk ( RR ) @ ; @ % confidence interval ( CI ) @ to @ -RSB- , maternal morbidity or neonatal morbidity .


The overall chance of surviving without long-term respiratory or neurodevelopmental disability is @/@ ( @ % ) : @/@ ( @ % ) in the AI arm and @/@ in the expectant arm ( @ % ) ( RR @ ; @ % CI @ to @ ) .


This pilot study found no major differences in maternal , perinatal or pregnancy outcomes .


The study was not designed to show a difference between the arms and the number of survivors was too small to draw any conclusions about long-term outcomes .


It does signal , however , that a larger , definitive , study to evaluate AI for improvement in healthy survival is indicated .


The results suggest that , with appropriate funding , such a study is feasible .


A larger , definitive , study with full health economic analysis and patient perspective assessment is required to show whether AI can improve the healthy survivor rate .


Emergency endovascular repair ( EVAR ) for ruptured abdominal aortic aneurysm ( rAAA ) may have lower operative mortality rates than open surgical repair .


Concerns remain that the early survival benefit after EVAR for rAAA may be offset by late reinterventions .


The aim of this study was to compare reintervention rates and cost-effectiveness of EVAR and open repair for rAAA .


A retrospective analysis was undertaken of patients with rAAA undergoing EVAR or open repair over @years .


A health economic model developed for the cost-effectiveness of elective EVAR was used in the emergency setting .


Sixty-two patients ( mean age @years ) underwent EVAR and @ ( mean age @years ) had open repair of rAAA .


Median follow-up was @ and @months respectively .


There was no significant difference in @-day mortality rates after EVAR and open repair ( @ and @ per cent respectively ; P = @ ) .


Reintervention rates were also similar ( @ and @ per cent ; P = @ ) .


The mean cost per patient was @,@ for EVAR and @,@ for open repair , and the cost per life-year gained was @ and @ respectively ( P = @ ) .


Open repair had greater initial costs : longer procedural times ( @ versus @min ; P < @ ) and intensive care stay ( @ versus @days ; P = @ ) .


Conversely , EVAR had greater reintervention ( @,@ versus @,@ ; P = @ ) and surveillance ( P < @ ) costs .


There was no significant difference in reintervention rates after EVAR or open repair for rAAA .


EVAR was as cost-effective at mid-term follow-up .


The increased procedural costs of open repair are not outweighed by greater surveillance and reintervention costs after EVAR .


To compare the effects of real-time continuous glucose monitoring ( RT-CGM ) and an Internet blood glucose monitoring system ( IBGMS ) on glycated hemoglobin levels in patients with type @ diabetes mellitus treated with insulin .


Fifty-seven patients with type @ diabetes treated with insulin were assigned randomly to @ of @ groups .


Group @ had the results of their self-monitoring of blood glucose level monitored biweekly using an IBGMS .


Group @ used RT-CGM and were monitored biweekly .


Both groups used a secure website to upload data and to receive feedback from their endocrinologist .


A@C and laboratory test results were collected at @ , @ and @ months .


The baseline parameters were not significantly different .


After a @-month follow-up period , both IBGMS and RT-CGM showed significant within-group improvements in A@C level .


In the IBGMS group , the A@C level decreased from @ % @ % to @ % @ % ( p < @ ) .


The RT-CGM group decreased from @ % @ % to @ % @ % ( p < @ ) .


IBGMS and RT-CGM did not show significantly different A@C levels at baseline , @ and @ months ( p > @ ) .


The use of both IBGMS and RT-CGM significantly improved A@C levels in patients with type @ diabetes treated with insulin in a randomized trial over a @-month period .


There were no significant differences in A@C values between groups after @ months .


The aim of this study was to investigate the effects of a noninvasive positive pressure ventilation therapy on cardiac structure and function in patients with coronary heart disease combined with obstructive sleep apnea/hypopnea syndrome ( OSAHS ) .


Eighty patients with coronary heart disease OSAHS were divided randomly into treatment ( n = @ ) and control ( n = @ ) groups .


Both groups received standard medications .


The treatment group received additional noninvasive mechanical ventilation support for at least @ h ( @-@ h ) every night .


On the first day after selection and @ months afterwards , participants were examined with echocardiograms , @-h ambulatory blood pressure monitoring , and blood analyses .


Primary endpoints were left ventricular end-diastolic diameter , left ventricular end-systolic diameter , left ventricular ejection fraction , left atrial diameter as well as serum concentrations of N-terminal prohormone of brain natriuretic peptide , and high-sensitive C-reactive protein .


Secondary endpoints included cardiac death , nonfatal myocardial infarction , and hospitalization .


After the @-month study period , patients in the treatment group showed significantly improved left ventricular end-diastolic diameter ( P = @ ) , left ventricular end-systolic diameter ( P = @ ) , left ventricular ejection fraction ( P = @ ) , and left atrial diameter ( P = @ ) values , and their serum N-terminal prohormone of brain natriuretic peptide ( P = @ ) and high-sensitive C-reactive protein ( P = @ ) concentrations were significantly improved compared with the control group .


During the @ months , three cardiovascular complications occurred in the treatment group versus nine in the control group ( P < @ ) .


For patients with coronary heart disease combined with OSAHS , noninvasive mechanical ventilation therapy can significantly improve heart functions and reduce the occurrence of cardiovascular complications .


After an intense bout of exercise , foam rolling is thought to alleviate muscle fatigue and soreness ( ie , delayed-onset muscle soreness -LSB- DOMS -RSB- ) and improve muscular performance .


Potentially , foam rolling may be an effective therapeutic modality to reduce DOMS while enhancing the recovery of muscular performance .


To examine the effects of foam rolling as a recovery tool after an intense exercise protocol through assessment of pressure-pain threshold , sprint time , change-of-direction speed , power , and dynamic strength-endurance .


Controlled laboratory study .


University laboratory .


A total of @ healthy , physically active males ( age = @ @ years , height = @ @ cm , mass = @ @ kg ) participated .


Participants performed @ conditions , separated by @ weeks , involving @ sets of @ repetitions of back squats at @ % of their @-repetition maximum , followed by either no foam rolling or @ minutes of foam rolling immediately , @ , and @ hours postexercise .


Pressure-pain threshold , sprint speed ( @-m sprint time ) , power ( broad-jump distance ) , change-of-direction speed ( T-test ) , and dynamic strength-endurance .


Foam rolling substantially improved quadriceps muscle tenderness by a moderate to large amount in the days after fatigue ( Cohen d range , @ to @ ) .


Substantial effects ranged from small to large in sprint time ( Cohen d range , @ to @ ) , power ( Cohen d range , @ to @ ) , and dynamic strength-endurance ( Cohen d = @ ) .


Foam rolling effectively reduced DOMS and associated decrements in most dynamic performance measures .


Evaluate a computerized intervention supporting antiretroviral therapy ( ART ) adherence and HIV transmission prevention .


Longitudinal randomized controlled trial .


An academic HIV clinic and a community-based organization in Seattle .


In a total of @ HIV-positive adults on ART , @ completed @-month follow-up ( @ % retention ) .


Randomization to computerized counseling or assessment only , @ sessions over @ months .


HIV-@ viral suppression , and self-reported ART adherence and transmission risks , compared using generalized estimating equations .


Overall , intervention participants had reduced viral load : mean @ log@ decline , versus @ increase in controls , P = @ , and significant difference in ART adherence baseline to @ months ( P = @ ) .


Their sexual transmission risk behaviors decreased ( odds ratio = @ , P = @ ) , a reduction not seen among controls ( odds ratio = @ , P = @ ) , and a significant difference in change ( P = @ ) .


Intervention effect was driven by those most in need ; among those with detectable virus at baseline ( > @ copies/mL , n = @ ) , intervention effect was mean @ log@ viral load decline versus @ increase in controls , P = @ .


ART adherence at the final follow-up was @ points higher among intervention participants versus controls , P = @ .


Computerized counseling is promising for integrated ART adherence and safer sex , especially for individuals with problems in these areas .


This is the first intervention to report improved ART adherence , viral suppression , and reduced secondary sexual transmission risk behavior .


Ureteric stones greater than @mm require intervention .


Extracorporeal shockwave lithotripsy ( ESWL ) and ureteroscopy ( URS ) with intra-corporeal lithotripsy ( ICL ) are two least invasive therapies .


Both show acceptable stone clearance .


What should be the first line of treatment in distal ureteric stones ?


We conducted this study to compare the efficacy-of ESWL and pneumatic ICL in order to develop clear cut treatment guidelines .


This randomized control trial was conducted at Institute of Kidney Diseases , Peshawar from June @ to June @ .


Two hundred and twenty-four patients with distal ureteric stones @-@ mm in size were included .


Patients were randomized into two groups .


Group-A patients were treated with URS plus ICL and Group-B with ESWL .


Patients were evaluated for stone clearance after @ weeks , with X-ray KUB and ultrasound .


All the data were recorded in a pro forma and analysed in SPSS @ .


Fisher 's exact test was applied to compare the efficacy and a p-value of @ was considered significant .


Out of @ patients in Group-A , @ ( @ % ) were males and @ ( @ % ) were females while in Group-B @ ( @ % ) were males and @ ( @ % ) were females .


The mean age in Group-A was , @ + / - @ years whereas it was @ + / - @ years in Group-B .


Overall , mean age was @ + / -@ years .


Mean stone size was @ + / - @ mm .


At follow up ( @ weeks post-operative ) URS with ICL was successful in @ ( @ % ) patients while ESWL was successful in @ ( @ % ) patients ( p-value = @ ) .


Extracorporeal shockwave lithotripsy shows acceptable stone clearance but ureteroscopy with intra-corporeal lithotripsy shows superior results in distal ureteric stones .


Preclinical and early clinical data support the use of Vascular Epithelial Growth Factor ( VEGF ) - targeted therapy with trastuzumab in Human Epidermal Receptor @ ( HER@ ) positive breast cancer .


Adding bevacizumab to a taxane ( docetaxel or paclitaxel ) improves progression free survival ( PFS ) of metastatic breast cancer ( MBC ) patients .


We evaluated the efficacy and feasibility of combining bevacizumab with trastuzumab and docetaxel in patients with HER@ - positive MBC who received @-@ prior chemotherapy regimens for metastatic disease .


The primary end point was PFS .


Eligible patients received bevacizumab ( @ mg/kg ) , trastuzumab ( @ mg/kg loading dose followed by @ mg/kg ) , and docetaxel ( @ mg/m@ initially , later amended to @ mg/m@ ) every three weeks for six cycles and then were allowed to receive bevacizumab and trastuzumab alone .


Results Thirteen ( @ % ) of @ patients enrolled completed all @ cycles of bevacizumab , trastuzumab and docetaxel and went on to receive bevacizumab and trastuzumab alone ( median : @ cycles ) .


The most common grade @ or @ toxicities include : neutropenia ( @ % ) , septic death ( @ % ) , infection not associated with neutropenia ( @ % ) , fatigue ( @ % ) , mylagia and/or arthraligia ( @ % ) , and hand-foot syndrome ( @ % ) .


One patient ( @ % ) and six patients ( @ % ) developed grade @ and grade @ hypertension , respectively .


Two ( @ % ) patients had transient grade @ drop in Left Ventricular Ejection Fraction ( LVEF ) with full recovery later .


The median progression free survival ( PFS ) was @ months ( @ % CI : @-@ months ) , the objective response rate ( ORR ) , defined as the best response of complete response ( CR ) or partial response ( PR ) was ( @/@ ) @ % .


The clinical benefit rate ( CBR ) , defined as the best response of CR or PR or stable disease ( SD ) for at least @ weeks , was ( @/@ ) @ % ( @ % CI : @-@ % ) .


The combination of bevacizumab , trastuzumab and docetaxel is well tolerated and is clinically active in patients with HER@-positive MBC , with response rate and PFS comparable to previous reports utilizing higher dose of docetaxel ( @ mg/m@ ) .


Recent randomized trials did not demonstrate additional overall survival ( OS ) benefit of adding bevacizumab to trastuzumab and docetaxel despite an improvement in PFS .


Identification of predictive biomarkers and careful patient selection should be incorporated in further investigation of anti-VEGF in breast cancer .


The purpose of this study was to determine among maintenance hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension whether in comparison with a - blocker-based antihypertensive therapy , an angiotensin converting enzyme-inhibitor-based antihypertensive therapy causes a greater regression of left ventricular hypertrophy .


Subjects were randomly assigned to either open-label lisinopril ( n = @ ) or atenolol ( n = @ ) each administered three times per week after dialysis .


Monthly monitored home blood pressure ( BP ) was controlled to < @/@ mmHg with medications , dry weight adjustment and sodium restriction .


The primary outcome was the change in left ventricular mass index ( LVMI ) from baseline to @ months .


At baseline , @-h ambulatory BP was similar in the atenolol ( @ / @ mmHg ) and lisinopril groups , and improved similarly over time in both groups .


However , monthly measured home BP was consistently higher in the lisinopril group despite the need for both a greater number of antihypertensive agents and a greater reduction in dry weight .


An independent data safety monitoring board recommended termination because of cardiovascular safety .


Serious cardiovascular events in the atenolol group occurred in @ subjects , who had @ events , and in the lisinopril group in @ subjects , who had @ events -LCB- incidence rate ratio ( IRR ) @ -LSB- @ % confidence interval ( @ % CI ) @-@ @ , P = @ -RSB- -RCB- .


Combined serious adverse events of myocardial infarction , stroke and hospitalization for heart failure or cardiovascular death in the atenolol group occurred in @ subjects , who had @ events and in the lisinopril group in @ subjects , who had @ events ( IRR @ , P = @ ) .


Hospitalizations for heart failure were worse in the lisinopril group ( IRR @ , P = @ ) .


All-cause hospitalizations were higher in the lisinopril group -LSB- IRR @ ( @ % CI @-@ @ , P = @ ) -RSB- .


LVMI improved with time ; no difference between drugs was noted .


Among maintenance dialysis patients with hypertension and left ventricular hypertrophy , atenolol-based antihypertensive therapy may be superior to lisinopril-based therapy in preventing cardiovascular morbidity and all-cause hospitalizations .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases ; ClinicalTrials.gov number : NCT@ ) .


We tested a modified Network for the Improvement of Addiction Treatment ( NIATx ) process improvement model to implement improved HIV services ( prevention , testing , and linkage to treatment ) for offenders under correctional supervision .


As part of the Criminal Justice Drug Abuse Treatment Studies , Phase @ , the HIV Services and Treatment Implementation in Corrections study conducted @ cluster-randomized trials in @ to @ at @ US sites , where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training .


The outcome measure was the odds of successful delivery of an HIV service .


The results were significant at the @ level , and the point estimate for the odds ratio was @ .


Although overall the results were heterogeneous , the experiments that focused on implementing HIV prevention interventions had a @ % confidence interval that exceeded the no-difference point .


Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments .


Based on experimental results , various authors have advocated a size @ ProSeal laryngeal mask airway ( PLMA ) in preference to a size @ PLMA for women given a neuromuscular blocking agent because the larger size provided a better airway seal .


However , spontaneously breathing patients may be ventilated adequately with a lower seal pressure than that needed for mechanical ventilation .


Therefore , a smaller size might be preferable as its reduced bulk possibly induces less mucosal damage in non-paralyzed patients .


A total of @ females undergoing general anesthesia for short outpatient gynecological surgeries were randomly allocated in equal numbers to insertion of a size @ or @ PLMA .


The insertion time , success rate , seal pressure , hemodynamic variables , and complications , such as blood staining and sore throat , were evaluated .


The incidence of blood staining was lower with the size @ PLMA compared to the size @ PLMA ( @ vs. @ % ; P = @ ) .


Compared with the size @ LMA , the size @ PLMA resulted in higher fluctuations in both blood pressure ( P = @ ) and heart rate ( P = @ ) .


The insertion time was shorter with the size @ PLMA ( @ vs. @s ; P < @ ) .


The airway seal pressure with the size @ PLMA , although lower than that of the size @ PLMA ( @ vs. @ cmH@O ; P = @ ) , was sufficient for spontaneous ventilation .


Due to the reduced incidence of mucosal injury and greater hemodynamic stability , the size @ PLMA may be preferable to the size @ PLMA for non-paralyzed females .


Asymptomatic hyperuricemia increases renal and cardiovascular ( CV ) risk .


We previously conducted a @-year , single-blind , randomized , controlled trial of allopurinol treatment that showed improved estimated glomerular filtration rate and reduced CV risk .


Post hoc analysis of a long-term follow-up after completion of the @-year trial .


@ participants ( @ in the allopurinol group and @ in the control group ) initially followed up for @ years and @ participants followed up to @ additional years .


Continuation of allopurinol treatment , @mg/d , or standard treatment .


Renal event ( defined as starting dialysis therapy and/or doubling serum creatinine and/or @ % decrease in estimated estimated glomerular filtration rate ) and CV events ( defined as myocardial infarction , coronary revascularization or angina pectoris , congestive heart failure , cerebrovascular disease , and peripheral vascular disease ) .


During initial follow-up , there were @ renal and @ CV events in the allopurinol group compared with @ renal and @ CV events in the control group .


In the long-term follow-up period , @ of @ participants taking allopurinol stopped treatment and @ of @ control participants received allopurinol .


During long-term follow-up , an additional @ and @ participants in the allopurinol group experienced a renal or CV event , respectively , and an additional @ and @ participants in the control group experienced a renal or CV event , respectively .


Thus , during the initial and long-term follow-up ( median , @ months ) , @ patients in the allopurinol group had a renal event compared with @ patients in the control group ( HR , @ ; @ % CI , @-@ @ ; P = @ ; adjusted for age , sex , baseline kidney function , uric acid level , and renin-angiotensin-aldosterone system blockers ) .


Overall , @ patients treated with allopurinol experienced CV events compared with @ in the control group ( HR , @ ; @ % CI , @-@ @ ; P = @ ; adjusted for age , sex , and baseline kidney function ) .


Small sample size , single center , not double blind , post hoc follow-up and analysis .


Long-term treatment with allopurinol may slow the rate of progression of kidney disease and reduce CV risk .


This investigation compared cotinine ( primary metabolite of nicotine ) at study intake to self-report metrics ( e.g. , Fagerstrom Test of Nicotine Dependence -LSB- FTND -RSB- ) and assessed their relative ability to predict smoking outcomes .


We used data from an analog model of contingency management for cigarette smoking .


Non-treatment seeking participants ( N = @ ) could earn money in exchange for provision of a negative carbon monoxide ( CO ) sample indicating smoking abstinence , but were otherwise not motivated to quit .


We used intake cotinine , FTND , percent of friends who smoke , and years smoked to predict longitudinal CO and attendance , time-to-first positive CO submission , and additional cross-sectional outcomes .


Intake cotinine was consistently predictive ( p < @ ) of all outcomes ( e.g. , longitudinal CO and attendance , @ % abstinence , time-to-first positive CO sample ) , while years smoked was the only self-report metric that demonstrated any predictive ability .


Cotinine could be more informative for tailoring behavioral treatments compared to self-report measures .


Tocopherols were discovered for their role in animal reproduction , but little is known about the contribution of deficiencies of vitamin E to human pregnancy loss .


We sought to determine whether higher first-trimester concentrations of - tocopherol and - tocopherol were associated with reduced odds of miscarriage ( pregnancy losses < @ wk of gestation ) in women in rural Bangladesh .


A case-cohort study in @ pregnant Bangladeshi women -LSB- median ( IQR ) gestational age : @ wk ( @-@ wk ) -RSB- who participated in a placebo-controlled vitamin A - or - carotene-supplementation trial was done to assess ORs of miscarriage in women with low - tocopherol ( < @ mol/L ) and - tocopherol ( < @ mol/L ; upper tertile cutoff of the - tocopherol distribution in women who did not miscarry ) .


In all women , plasma - and - tocopherol concentrations were low -LSB- median ( IQR ) : @ mol/L ( @-@ @ mol/L ) and @ mol/L ( @-@ @ mol/L ) , respectively -RSB- .


In a logistic regression analysis that was adjusted for cholesterol and the other tocopherol , low - tocopherol was associated with an OR of @ ( @ % CI : @ , @ ) , whereas a low - tocopherol concentration was associated with an OR of @ ( @ % CI : @ , @ ) for miscarriage .


Subgroup analyses revealed that opposing ORs were evident only in women with BMI ( in kg/m ( @ ) ) @ and serum ferritin concentration @ g/L , although low BMI and elevated ferritin conferred stronger risk of miscarriage .


In pregnant women in rural Bangladesh , low plasma - tocopherol was associated with increased risk of miscarriage , and low - tocopherol was associated with decreased risk of miscarriage .


Maternal vitamin E status in the first trimester may influence risk of early pregnancy loss .


The JiVitA-@ study , from which data for this report were derived , was registered at clinicaltrials.gov as NCT@ .


The routine use of neuromuscular blocking agents reduces the occurrence of unacceptable surgical conditions .


In some surgeries , such as retroperitoneal laparoscopies , deep neuromuscular block ( NMB ) may further improve surgical conditions compared with moderate NMB .


In this study , the effect of deep NMB on surgical conditions was assessed .


Twenty-four patients undergoing elective laparoscopic surgery for prostatectomy or nephrectomy were randomized to receive moderate NMB ( train-of-four @-@ ) using the combination of atracurium/mivacurium , or deep NMB ( post-tetanic count @-@ ) using high-dose rocuronium .


After surgery , NMB was antagonized with neostigmine ( moderate NMB ) , or sugammadex ( deep NMB ) .


During all surgeries , one surgeon scored the quality of surgical conditions using a five-point surgical rating scale ( SRS ) ranging from @ ( extremely poor conditions ) to @ ( optimal conditions ) .


Video images were obtained and @ anaesthetists rated a random selection of images .


Mean ( standard deviation ) SRS was @ ( @ ) during moderate and @ ( @ ) during deep NMB ( P < @ ) .


Moderate block resulted in @ % of scores at the low end of the scale ( Scores @-@ ) ; deep block resulted in @ % of scores at the high end of the scale ( Scores @ and @ ) .


Cardiorespiratory conditions were similar during and after surgery in both groups .


Between anaesthetists and surgeon , there was poor agreement between scores of individual images ( average statistic @ ) .


Application of the five-point SRS showed that deep NMB results in an improved quality of surgical conditions compared with moderate block in retroperitoneal laparoscopies , without compromise to the patients ' peri - and postoperative cardiorespiratory conditions .


Trial registration The study was registered at clinicaltrials.gov under number NCT@ .


To determine if injection of local anesthetic into trocar insertion sites after laparoscopy improves postoperative pain .


A prospective , @-arm , randomized , double-blind , stratified , and controlled trial ( Canadian Task Force classification I ) .


A university-based teaching hospital .


This study was performed on women who had a laparoscopic gynecologic procedure for benign indications from March @ to June @ .


One hundred thirty-five subjects were stratified by chronic pelvic pain or no chronic pelvic pain .


Chronic pelvic pain was defined as pelvic pain occurring for @ months or more in duration .


Randomization was performed for this trial , with @ receiving a bupivacaine block and @ receiving no bupivacaine block .


Of the @ patients with chronic pelvic pain , @ patients were in group @ ( i.e. , bupivacaine block ) and @ patients were in group @ ( i.e. , no bupivacaine block ) .


After the laparoscopic surgery was completed , the trocar incision sites were closed .


For subjects randomized to receive a local anesthesia block , bupivacaine ( @ % ) was injected .


Incisions @ mm or greater were injected with @ mL @ % bupivacaine .


Incisions @ mm or less were infiltrated with @ mL .


Injecting the local anesthetic through all preperitoneal layers provided a full-thickness local injection .


Group @ did not receive a local injection .


At the preoperative suite , the nurses gauged the patient 's pain using the Numeric Rating Scale .


This score was used as the baseline pain level with which the postoperative pain scores were compared .


The primary objective was to measure changes in pain scores , from preoperative to postoperative time frames of @ to @ hours , @ to @ hours , @ to @ hours , and @ to @ days postoperatively .


These score changes were measured as the main objective .


Secondary objectives include estimated blood loss , operating time , length of hospital stay , and histopathologic diagnosis .


The hospital personnel caring for the patient during the preoperative and postoperative course were given standard pain evaluation protocols .


All study pain evaluators and patients were blinded to treatment assignments throughout the pain assessment process .


There were no statistically significant differences in patient characteristics between the @ treatment groups .


No significant difference was found in secondary outcomes including estimated blood loss , length of hospital stay , and histopathologic diagnosis .


In general , Numeric Rating Scale pain scores were lower ( i.e. , less pain ) in the `` bupivacaine block '' group compared with the `` no bupivacaine '' block group at the following postsurgery time assessments : @ to @ hours , @ to @ hours , @ to @ hours , and @ to @ days after surgery .


However , the effect was not large enough ( < @ point ) to show a statistical difference between the treatment groups at any of these postsurgery assessments .


The postoperative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery .


The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-@ study .


SYMPLICITY HTN-@ randomized @ subjects with treatment-resistant hypertension to renal denervation or medical therapy alone .


At @ months , @ control subjects crossed over to renal denervation .


Office blood pressure measurements , antihypertensive medication use , and safety events were followed every @ months through @ years .


Follow-up was available at @ months in @ of @ subjects in the initial renal denervation group and at @ months in @ of @ subjects who crossed over and received renal denervation at @ months .


Baseline blood pressure was @ @/@ @ mmHg in all treated subjects .


At @-month post-procedure , systolic blood pressure decreased @ mmHg ( @ % CI : -@ , -@ , P < @ ) and diastolic blood pressure decreased @ mmHg ( @ % CI : -@ , -@ , P < @ ) .


The systolic and diastolic blood pressure reduction at @ months for the initial renal denervation group was -@ mmHg ( @ % CI : -@ , -@ , P < @ ) and -@ mmHg ( @ % CI : -@ , -@ , P < @ ) , respectively .


Procedural complications included one haematoma , and one renal artery dissection before energy delivery that was treated successfully .


Later complications included two cases of acute renal failure , which fully resolved , @ hypertensive events requiring hospitalization , and three deaths .


Renal denervation resulted in sustained lowering of blood pressure at @ years in a selected population of subjects with severe , treatment-resistant hypertension without serious safety concerns .


To compare onset time and quality of sedation achieved by IM injection of hydromorphone and dexmedetomidine into either the semimembranosus , cervical , gluteal , or lumbar muscle groups in dogs .


Prospective , randomized , crossover study .


@ dogs .


Each dog was assigned to receive each treatment in random order , and at least @ week elapsed between treatments .


Dogs were sedated with dexmedetomidine and hydromorphone combined and injected IM into the assigned muscle group .


An observer unaware of group assignments assessed physiologic variables every @ minutes for @ minutes , and a videographic recording was obtained .


Recordings were evaluated by @ individuals who were unaware of group assignments ; these reviewers assessed time to onset of sedation and assigned a sedation score to each dog every @ minutes .


Resting pulse and respiratory rates did not differ among injection site groups .


The semimembranosus site had a significantly higher sedation score than all other sites , and the cervical site had a significantly higher sedation score than the lumbar and gluteal sites .


The semimembranosus and cervical sites had significantly shorter time to onset of sedation than did the gluteal and lumbar sites .


When the combination of dexmedetomidine and hydromorphone was used to induce sedation in dogs , rapid and profound sedation was achieved with IM injection into the semimembranosus muscle .


Despite the laparoscopic approach becoming the standard in colorectal surgery , postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures .


Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery .


Epidural analgesia provides excellent analgesia , but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced .


Moreover , epidural analgesia can be associated with numerous complications .


Therefore , epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery .


Likewise , patient-controlled intravenous analgesia is subject to significant side effects .


Given these important limitations of the traditional strategies for postoperative analgesia , effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed .


Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery .


We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine .


One hundred and twenty five patients undergoing laparoscopic colorectal surgery will be included in this prospective , randomized , double-blind controlled clinical trial .


Patients will be randomly allocated to three different postoperative strategies : postoperative patient-controlled intravenous analgesia with morphine ( control group , n = @ ) , a transversus abdominis plane block with ropivacaine @ % at the end of surgery plus postoperative patient-controlled intravenous analgesia with morphine ( TAP group , n = @ ) , or perioperative intravenous lidocaine plus postoperative patient-controlled intravenous analgesia with morphine ( LIDO group , n = @ ) .


As the primary outcome parameter , we will evaluate the opioid consumption during the first @ postoperative hours .


Secondary endpoints include the Numeric Rating Scale , time to return of intestinal function , time to mobilization , inflammatory response , incidence of postoperative nausea and vomiting , length of hospital stay and postoperative morbidity as assessed with the Clavien-Dindo classification .


Recognizing the importance of a multimodal approach for perioperative pain management , we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone .


Musculoskeletal disorders are the most frequent occupational diseases in Europe .


However , their multifactorial aetiology poses several challenges concerning not only the estimation of relative prevalence rates across occupational groups but also how the co-occurrence of known risk factors might differ between disorders of the upper and lower limbs .


Against this background , the following objectives are pursued : ( @ ) to estimate the relative odds and prevalence rates of self-reported disorders of the upper limbs and/or shoulders and neck ( upper body ) and the lower limbs for major ISCO-@ occupational groups , ( @ ) to evaluate to what extent the associations between known risk factors differ for musculoskeletal disorders of the upper body and the lower limbs .


Statistical analysis of cross-sectional data from the European Working Conditions Survey @-@ .


The probability of reporting upper body and lower limbs pain in the survey sample @ is estimated by mixed logistic regression models using the Markov chain Monte Carlo Sampler .


Independent variables include some known physical and psychosocial risk factors .


Concerning the first objective , an excess risk of reporting musculoskeketal disorders of the upper body was observed among craft workers ( ISCO @ ) , machine operators ( ISCO @ ) and workers in elementary occupations ( ISCO @ ) .


Concerning musculoskeletal disorders of the lower limbs , service and sales workers ( ISCO @ ) and workers in ISCO groups @ , @ and @ reported symptoms more frequently .


Regarding the second objective , similar association patterns were observed for upper body and lower limbs symptoms .


Major physical risk factors associated with both symptom types were very frequent exposure to tiring positions , carrying heavy loads and performing repetitive tasks .


Standing appears to be an important risk factor for lower limbs symptoms only .


Results suggest that the unequal burden of exposure has not changed substantially across occupational groups since @ , and that there is urgent need of delivering and evaluating the effects of specific interventions targeting workers at high risk of developing musculoskeletal disorders .


Medical conditions are often complicated by major depression , with consequent additional impairment of quality of life .


We aimed to compare the effectiveness of an integrated treatment programme for major depression in patients with cancer ( depression care for people with cancer ) with usual care .


SMaRT Oncology-@ is a parallel-group , multicentre , randomised controlled effectiveness trial .


We enrolled outpatients with major depression from three cancer centres and their associated clinics in Scotland , UK .


Participants were randomly assigned in a @:@ ratio to the depression care for people with cancer intervention or usual care , with stratification ( by trial centre ) and minimisation ( by age , primary cancer , and sex ) with allocation concealment .


Depression care for people with cancer is a manualised , multicomponent collaborative care treatment that is delivered systematically by a team of cancer nurses and psychiatrists in collaboration with primary care physicians .


Usual care is provided by primary care physicians .


Outcome data were collected up until @ weeks .


The primary outcome was treatment response ( @ % reduction in Symptom Checklist Depression Scale -LSB- SCL-@ -RSB- score , range @-@ ) at @ weeks .


Trial statisticians and data collection staff were masked to treatment allocation , but participants could not be masked to the allocations .


Analyses were by intention to treat .


This trial is registered with Current Controlled Trials , number ISRCTN@ .


@ participants were enrolled between May @ , @ , and May @ , @ ; @ were randomly allocated to depression care for people with cancer and @ to usual care .


@ ( @ % ) of @ participants in the depression care for people with cancer group and @ ( @ % ) of @ in the usual care group responded to treatment : absolute difference @ % ( @ % CI @-@ ) , adjusted odds ratio @ ( @ % CI @-@ ) , p < @ .


Compared with patients in the usual care group , participants allocated to the depression care for people with cancer programme also had less depression , anxiety , pain , and fatigue ; and better functioning , health , quality of life , and perceived quality of depression care at all timepoints ( all p < @ ) .


During the study , @ cancer-related deaths occurred ( @ in the depression care for people with cancer group , @ in the usual care group ) , one patient in the depression care for people with cancer group was admitted to a psychiatric ward , and one patient in this group attempted suicide .


None of these events were judged to be related to the trial treatments or procedures .


Our findings suggest that depression care for people with cancer is an effective treatment for major depression in patients with cancer .


It offers a model for the treatment of depression comorbid with other medical conditions .


Buprenorphine is a promising treatment for heroin addiction .


However , little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant , the relative effectiveness of the post-release setting in which it is provided , and gender differences in treatment outcome in this population .


This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration .


A total of @ participants with @-@ months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition ( received buprenorphine vs. counseling only ) and Post-release Service Setting ( at an opioid treatment center vs. a community health center ) .


Outcome measures were : entered prison treatment ; completed prison treatment ; and entered community treatment @ days post-release .


There was a significant main effect ( p = @ ) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition ( @ % vs. @ % ) .


Regarding completing prison treatment , the only significant effect was Gender , with women significantly ( p < @ ) more likely to complete than men ( @ % vs. @ % ) .


There was a significant main effect ( p = @ ) for community treatment entry , favoring the In-Prison buprenorphine Treatment Condition ( @ % vs. @ % ) .


Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry .


However , concerns remain with in-prison treatment termination due to attempted diversion of medication .


We evaluated the efficacy of sub-Tenon block in decreasing perioperative pain , incidence of intraoperative oculocardiac reflex ( OCR ) , and postoperative nausea and vomiting ( PONV ) in pediatric squint surgery .


A total of @ children age @-@ years , American Society of Anesthesiologists Physical Status @ and @ , were randomized to receive either sub-Tenon block ( ST ) in the operative eye or @ mcg/kg of intravenous fentanyl ( F ) for squint surgery after induction of general anesthesia in this double-blind study .


Postoperative pain was measured by either modified Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) or Visual Analogue Scale ( VAS ) .


Pain in the postoperative period ( up to @ hours ) was measured as the primary endpoint .


Other parameters measured in the groups were intraoperative hemodynamics , postoperative modified CHEOPS or VAS at shifting , @ , @ , @ , @ , and @ hours after surgery , incidence of intraoperative OCR , and PONV at shifting , @ minutes , @ , @ , @ , @ , and @ hours after surgery .


There was no statistical difference in the postoperative pain scores in the recovery room up to @ hours after surgery .


The VAS and CHEOPS scores were not different in the groups up to @ hours after surgery .


The incidence of OCR was significantly higher in group F than group ST. The incidence of PONV was significantly higher in group F than group ST at @ minutes and @ hour after the surgery ( @ % , @ % vs @ % , @ % , respectively , p < @ ) .


However , there was no statistically significant difference in intraoperative hemodynamics and PONV scores after @ hours in the postanesthesia care unit .


Use of sub-Tenon block does not decrease the incidence of postoperative pain significantly in children undergoing squint surgery .


However , it leads to a statistically significant decrease in the incidence of intraoperative OCR and PONV in the early recovery period in these patients .


This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial , which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells ( BMSCs ) in patients with ischemic heart failure .


The first @ patients recruited to the REGENERATE-IHD study are included in this interim analysis ( pilot ) .


Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only ; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum ( control ) .


No significant differences were found in terms of safety and feasibility between the different delivery routes , with no significant difference in procedural complications or major adverse cardiac events .


There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs .


Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure .


The purpose of this study was to prospectively evaluate the effect of benzyl alcohol , a common preservative in normal saline , on postprocedural pain after intraarticular injection for direct shoulder MR arthrography .


From April @ through January @ , @ patients underwent direct shoulder MR arthrography .


Using the Wong-Baker Faces Pain Scale , patients were asked to report their shoulder pain level immediately before and immediately after the procedure and then were contacted by telephone @ , @ , and @ hours after the procedure .


Fourteen patients did not receive the prescribed amount of contrast agent for diagnostic reasons or did not complete follow-up .


Sixty-two patients received an intraarticular solution including preservative-free normal saline ( control group ) and @ patients received an intraarticular solution including normal saline with @ % benzyl alcohol as a contrast diluent ( test group ) .


Patients were randomized as to which intraarticular diluent they received .


Fluoroscopic and MR images were reviewed for extracapsular contrast agent administration or extravasation , full-thickness rotator cuff tears , and adhesive capsulitis .


The effect of preservative versus control on pain level was estimated with multiple regression , which included time after procedure as the covariate and accounted for repeated measures over patients .


Pain scale scores were significantly ( p = @ ) higher ( @ units ; @ % CI , @-@ @ ) with benzyl alcohol preservative compared with control ( saline ) .


In both study arms , the pain scale scores decreased slightly after the procedure , increased by roughly @ unit over baseline for the test group and @ unit over baseline for the control group by @ hours after the procedure , were @ unit over baseline for the test group and @ unit over baseline for the control group at @ hours , then fell to be slightly greater than baseline at @ hours with benzyl alcohol and slightly less than baseline without benzyl alcohol .


These trends over time were highly significant ( p < @ ) .


Shoulder arthrography is often associated with postprocedural discomfort that begins immediately after the procedure and resolves by @ hours .


There is significantly increased patient discomfort at @ and @ hours when using normal saline preserved with benzyl alcohol as a diluent compared with using normal saline without preservative as a diluent .


Antecedents of smoking have been widely researched in studies with older adults .


However , less is known about the smoking patterns and antecedents of smoking in young adult smokers .


In this study , we used ecological momentary assessment collected with an Internet-based survey instrument and used the participants ' own mobile phones to contrast the smoking patterns of young adult light and intermittent smokers ( n = @ ) with heavy smokers ( n = @ ) .


Overall , @ smoking and non-smoking situations were analysed .


By means of generalised estimating equations , we used a range of situational characteristics to predict smoking in both groups .


Craving and smoking of others increased the odds of smoking , and smoking bans were associated with a decreased probability of smoking among both light and intermittent smokers and heavy smokers .


Situational antecedents differed between both groups .


Cue-associated smoking played a bigger role for light and intermittent smokers than for heavy smokers .


Situational antecedents , such as craving , being at the home of others , drinking alcohol and smoking by others , were more strongly associated with the smoking of light and intermittent smokers compared with heavy smokers .


Smoking among young adults is associated with both internal and external situational characteristics .


Compared with heavy smokers , light and intermittent smoking seems to be under more stimulus control and more characterised by social smoking .


These results are consistent with several findings from previous studies and provide further information on different subgroups of smokers in early adulthood .


To compare the quality of data collection via electronic data capture ( EDC ) with voiced questionnaire ( QNN ) and data image capture features using a tablet versus standard paper-based QNN , to assess the user 's perception of using the EDC tool , and to compare user satisfaction with the two methods .


Randomised cross-over study .


Study sites : This study was conducted in two villages along the Thailand-Myanmar border .


This study included @ community health volunteers ( CHVs ) and @ Karen hill tribe villagers .


Employing a cross-over study design , the CHVs were allocated randomly to two groups , in which they performed interviews in different sequences using EDC and QNN .


Data discrepancies were found between the two data-collection methods , when data from the paper-based and image-capture methods were compared , and when conducting skip pattern questions .


More than @ % of the CHVs perceived the EDC to be useful and easy to use .


Both interviewers and interviewees were more satisfied with the EDC compared with QNN in terms of format , ease of use , and system speed .


The EDC can effectively be used as an alternative method to paper-based QNNs for data collection .


It produces more accurate data that can be considered evidence-based .


Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes , few studies have been conducted .


Within musculoskeletal physiotherapy , the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed , but the impact of this mentoring on patient outcomes remains unknown .


The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy .


A stepped wedge cluster randomised controlled trial ( CRCT ) has been designed to recruit a minimum of @ senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service ( NHS ) organization .


Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods .


Patients will be blinded to whether their physiotherapist has received the intervention .


The primary outcome measure will be the Patient-Specific Functional Scale ; secondary outcome measures will include the EQ-@D , patient activation , patient satisfaction and physiotherapist performance .


Sample size considerations used published methods describing stepped wedge designs , conventional values of @ for statistical power and @ for statistical significance , and pragmatic groupings of @ participating physiotherapists in three clusters .


Based on an intergroup difference of @ on the PSFS with a standard deviation of @ , @ patients are required to complete outcome measures per physiotherapist , at time period @ ( prior to intervention roll-out ) and at each of time periods @ , @ and @ , giving a sample size of @ patients .


To account for the potential loss to follow-up of @ % , @ sets of patient outcomes will be collected.All physiotherapist participants will receive @ hours of mentored clinical practice as the intervention and usual in-service training as control .


Consecutive , consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline , discharge and @ months post-baseline .


The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data ; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters .


Walking and yoga have been independently evaluated for weight control ; however , there are very few studies comparing the @ with randomization .


The present study compared the effects of @ minutes/day for @ days of supervised yoga or supervised walking on : ( i ) related biochemistry , ( ii ) anthropometric variables , ( iii ) body composition , ( iv ) postural stability , and ( v ) bilateral hand grip strength in overweight and obese persons .


Sixty-eight participants , of whom @ were overweight ( BMI @ kg/m@ ) and @ were obese ( BMI @ kg/m@ ; group mean age S.D. , @ years ; @ females ) , were randomized as @ groups - ( i ) a yoga group and ( ii ) a walking group - given the same diet .


All differences were pre-post changes within each group .


Both groups showed a significant ( p < @ ; repeated measures ANOVA , post-hoc analyses ) decrease in : BMI , waist circumference , hip circumference , lean mass , body water , and total cholesterol .


The yoga group increased serum leptin ( p < @ ) and decreased LDL cholesterol ( p < @ ) .


The walking group decreased serum adiponectin ( p < @ ) and triglycerides ( p < @ ) .


Both yoga and walking improved anthropometric variables and serum lipid profile in overweight and obese persons .


The possible implications are discussed .


Benvitimod is a newly synthesized non-steroidal small molecule , aimed at the treatment for psoriasis .


Several trials have demonstrated that benvitimod improves plaque psoriasis .


However , its maximum tolerated dose and pharmacokinetic characteristics have not been reported on .


The goals of this study were to evaluate the safety , tolerability and pharmacokinetics of benvitimod after topical administration in healthy subjects .


This phase I trial in healthy subjects was designed as a randomized , double-blind , placebo-controlled , ascending-dose study .


After screening and randomization , @ volunteers received benvitimod ( @-@ % ) or placebo cream once or twice daily .


Doses were escalated from @ to @mg daily in six cohorts .


Safety and tolerability were appraised by monitoring adverse events and laboratory parameters .


Benvitimod concentrations were measured using liquid chromatography-tandem-mass spectrometry .


Exposure to benvitimod did not result in electrocardiographic or clinical laboratory changes .


Doses up to @mg were well tolerated .


All adverse events were mild .


Adverse effects at the application site were observed in subjects randomized to benvitimod @mg q.d and b.i.d , but there were no observable dose effects in the dose-range evaluated .


Benvitimod was detected in fewer than @ % of the plasma samples .


Benvitimod cream , at single doses of up to @mg , is well tolerated by healthy subjects .


Following topical application , systemic absorption was negligible .


Currently available preparations for colonoscopy have low tolerability and may cause fluid and electrolyte shifts .


An alternative method of bowel cleansing is required .


Preparation of the gut using oral nutritional supplements ( ONS ) and rectal enema was tested as an alternative method of bowel cleansing .


During @-@ , patients were randomized to oral nutritional supplements ( n = @ ) for @ days and rectal enema or polyethylene glycol ( PEG ) ( n = @ ) prior to colonoscopy .


Blinded endoscopists rated the degree of bowel cleansing according to the Ottawa bowel preparation scale ( OBS ) ( primary outcome ) .


Tolerability of either preparation was also assessed ( ClinicalTrials.gov .


Identifier no : NCT@ ) .


Due to a high rate of bowel cleansing failure among patients receiving ONS , the study was interrupted prematurely .


Colonoscopies were incomplete due to stools in @ of @ patients in the ONS group compared to @ of @ in the PEG group ( ns ) .


The mean total OBS were @ @ and @ @ , respectively ( p = @ ) .


Four patients ( @ % ) in the ONS group and eight patients ( @ % ) receiving PEG had an OBS score @ ( good preparation ) ( ns ) .


ONS was better tolerated than PEG with more patients reporting acceptable taste ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- , p = @ ) , and fewer reporting difficulties with the intake ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- , p < @ ) and nausea ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- , p < @ ) .


For routine use , ONS with enema instead of traditional preparation for colonoscopy with PEG can not be generally recommended .


To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil , regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to @g and diagnosed with respiratory distress syndrome .


Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant ( Butantan group ) or one of the following surfactants : Survanta or Curosurf .


Newborns receiving Survanta or Curosurf comprised the control group .


The main outcome measures were mortality rates at @ hours and at @ days of life ; the typical complications of prematurity as evaluated on the @th day of life were defined as secundary outcomes .


No differences were observed between the Butantan ( n = @ ) and control ( n = @ ) groups in relation to birth weight , gestational age , sex , and prenatal use of corticosteroids , or in mortality rates both at @ hours ( @ % versus @ % ; p = @ ) and at @ days ( @ % versus @ % ; p = @ ) of life .


Higher @ - and @-minute Apgar scores were observed among control group newborns .


No differences were observed as regards the secondary outcomes , except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group .


The mortality rates at @ hours and @ days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil , showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns .


To explore the influence of cefodizime on CD@/CD@ and T helper @ ( Th@ ) / Th@ cell ratios in peripheral blood of the senile patients with bacterial pneumonia .


Sixty-three senile patients with bacterial pneumonia were enrolled and divided into two groups randomly .


Patients in the control group ( n = @ ) were given intravenous infusion of ceftriaxone sodium , and patients in the observation group ( n = @ ) were given intravenous infusion of cefodizime .


The fasting venous blood was taken before and after treatment to detect CD@/CD@ and Th@/Th@ cell ratios with flow cytometry .


At the same time , the serum interleukin-@ ( IL-@ ) , interferon ( IFN - ) , IL-@ and IL-@ contents were also detected with ELISA .


Before treatment , there was no significant difference in the above indexes between the two groups .


After treatment , CD@ cells and Th@ cells of the observation group increased while Th@ cells decreased ; as a result , the CD@/CD@ and Th@/Th@ cell ratios of the observation group were significantly higher than those of the control group .


At the same time , serum IL-@ and IFN - contents of the observation group were significantly higher than those of the control group , while serum IL-@ and IL-@ contents were significantly lower than those of the control group .


Cefodizime can improve the cellular immune function and rectify CD@/CD@ and Th@/Th@ imbalance in peripheral blood of the senile patients with bacterial pneumonia .


The aim of this study was to evaluate the effects of radiotherapy plus concurrent weekly cisplatin chemotherapy on the postoperative recurrence of mediastinal lymph node metastases in esophageal cancer patients .


Ninety-eight patients were randomly enrolled to receive either three-dimensional conformal radiotherapy alone ( group A ) or concurrent chemoradiotherapy ( group B ) .


A radiation dose of @-@ Gy/@ -@ fractions was delivered to the recurrent tumor .


Furthermore , the patients in group B simultaneously received weekly doses of cisplatin ( @ mg/m ( @ ) ) , and the survival outcomes and toxic effects were compared .


The response rate of group B ( @ % ) was significantly greater than that of group A ( @ % ) ( ( @ ) = @ , P = @ ) .


The @ - and @-year survival rates of group B ( @ % and @ % , respectively ) were also greater than those of group A ( @ % and @ % , respectively ) .


However , there were no significant differences in the @-year survival rates .


The numbers of patients who died of distant metastases in groups A and B were @ ( @ % ) and @ ( @ % ) , respectively ( ( @ ) = @ , P = @ ) .


Acute radiation-related esophagitis and granulocytopenia in group B was frequent .


However , intergroup differences in terms of late toxicity were not significant .


Three-dimensional conformal radiotherapy ( @DCRT ) is a practical and feasible technique to treat the recurrence of mediastinal lymph node metastases of postoperative esophageal cancer .


In addition , concurrent chemotherapy can increase local tumor control , decrease the distant metastasis rate , and increase the long-term survival rate .


No specific antiviral agent against hand foot and mouth disease ( HFMD ) is available for clinical practice today .


To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD .


In this randomized , double-blind , placebo-controlled trial , @ children aged @ to @ years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo @ times daily for @ days with a @-day follow-up .


The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature ( fever clearance ) .


There were @ children enrolling into the Jinzhen group including @ with fever and @ into the placebo group including @ with fever .


Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to @ days ( @ % CI , @ to @ days ) , compared with @ days ( @ % CI , @ to @ days ) in the placebo group ( P = @ ) .


The median time of fever clearance was shorter in the @ children who received Jinzhen ( @ hrs , @ % CI , @ to @ ) than that in the @ children who received placebo ( @ hrs , @ % CI , @ to @ ) ( P = @ ) .


Moreover , Jinzhen reduced the risk of symptoms by @ % compared with placebo ( HR , @ , @ % CI , @ to @ , P = @ ) .