Our reviews showed that evidence was mixed regarding the effectiveness of different methods and theories to support change in prescribing practice .


Our design process is presented , drawing from this collective evidence .


We describe the final TACT intervention package ( including interactive small group workshops , feedback text messages , motivational text messages and patient information leaflets and posters ) in terms of its programme theory and implementation theory .


Our study suggests that evidence-based design of complex interventions is possible .


The use of formative research to understand malaria overdiagnosis in context was central to the design of the intervention as well as empirical research to test materials and methods prior to implementation .


The TACT interventions may be appropriate for other settings where clinicians face similar challenges with malaria diagnostics .


NCT01292707 .


Despite strong empirical support for the association between perceived food affordability and dietary intake amongst families with a lower socioeconomic position ( SEP ) , there is limited evidence of the most effective strategies for promoting more positive perceptions of healthy food affordability among this group .


This paper reports findings from a pilot intervention that aimed to improve perceptions of healthy food affordability amongst mothers .


Participants were 66 mothers who were the parents of children recruited from primary schools located in socioeconomically disadvantaged suburbs .


Intervention group participants viewed a slideshow focussed on healthy snack food affordability that illustrated cheaper healthier alternatives to common snack foods as well as food budgeting tips and price comparison education .


A mixed between-within ANCOVA was conducted to examine group differences in perceived affordability of healthy food across three time points .


Results revealed no difference in perceived affordability of healthy food between the two groups at baseline whereas at post-intervention and follow-up , mothers in the intervention group perceived healthy food as more affordable than the control group .


Focussing on education-based interventions to improve perceptions of healthy food affordability may be a promising approach that complements existing nutrition promotion strategies .


In burn care , a well-acknowledged problem is the suboptimal scar outcome from skin grafted burn wounds .


With the aim of improving this , we focused on a new technique : excision of the burn wound followed by primary closure , thereby using a skin-stretching device to stretch the adjacent healthy skin .


The short - and long-term effect of Skin Stretch was compared to split skin grafting ( SSG ) in a randomized controlled trial .


Patients with burn wounds were randomized for SSG or primary wound closure using Skin Stretch .


Follow-up was performed at 3 and 12 months postoperatively .


The scar surface area was calculated and the scar quality was assessed , using subjective and objective measurement methods .


No significant differences between the SSG and the Skin Stretch group were found for scar surface area .


In the Skin Stretch group , a significant reduction of the surface area from 65.4 cm ( 2 ) ( 13.6-129 .1 ) to 13.4 cm ( 2 ) ( 3.0-36 .6 ) was found at 3 months ( p = 0.028 ) and at 12 months postoperatively ( 65.4 cm ( 2 ) ( 13.6-129 .1 ) to 33.0 cm ( 2 ) ( 8.9-63 .7 ) , p = 0.046 , Wilcoxon signed ranks test ) .


Skin Stretch for primary closure of acute burn wounds is a suitable technique and can be considered for specific circumscript full-thickness burn wounds .


However , future research should be performed to provide additional scientific evidence .


Adequate bowel preparation is an important step for an effective colonoscopy .


Polyethylene glycol solution ( Kleanprep ) and sodium picosulphate with a magnesium citrate solution ( Picoprep ) are bowel cleansing agents registered and available for this purpose .


So far , the results of studies comparing the effectiveness of bowel cleansing between the two agents are inconclusive .


This may be because of differences in administration regimes and subjective measurement of bowel cleansing.In this single-blinded randomized-controlled trial , the effectiveness of Kleanprep and Picoprep was examined using a split-dose regimen and an objective bowel cleansing score system .


One hundred and seventy-three consecutive patients referred for outpatient colonoscopy were included , the required number based on power analysis .


Eighty-eight patients received Kleanprep ; 85 received Picoprep .


The primary outcome was the effectiveness of bowel cleansing using the Boston Bowel Preparation Score .


The secondary outcome was patient tolerability measured using a questionnaire .


An intention-to-treat-analysis was carried out .


The overall Boston Bowel Preparation Score between Kleanprep and Picoprep was not significantly different ( P = 0.182 ) .


On reviewing segment scores , there were also no significant differences between Kleanprep and Picoprep .


Patients using Picoprep scored significantly better on the aspects of convenience and flavour of the preparation agent compared with patients using Kleanprep ( P < 0.001 ) .


Side effects such as nausea ( P = 0.011 ) , vomiting ( P = 0.001 ) , headache ( P = 0.003 ) and bloating ( P < 0.001 ) were experienced less significantly by patients using Picoprep .


The present study did not find a difference in the effectiveness of bowel cleansing between Kleanprep and Picoprep .


Both were found to be adequate cleansing agents .


Picoprep was significantly better tolerated than Kleanprep .


Therefore , we recommend Picoprep as a first-choice regimen for bowel preparation before colonoscopy .


Psychotherapy for depression emphasizes techniques that can help individuals regulate their moods .


The present study investigated the affective impact and electrocortical correlates of cognitive restructuring , delivered as a 90-minute psychotherapeutic microintervention in a dysphoric sample .


Participants ( N = 92 ) who reported either low or high levels of dysphoric symptoms were randomly assigned to the restructuring microintervention , a control intervention or a no-intervention condition .


We obtained recordings of event-related potentials ( ERPs ) as well as mood self-ratings during an experimental session immediately after the psychotherapeutic microintervention and the control intervention in which a set of negatively valenced pictures ( IAPS ) was presented with different instructions .


Whereas the restructuring intervention group and the control intervention group reported both increases in positive and decreases in negative affect from pre - to post-intervention , the three groups differed significantly on ERP measures .


Findings provide support for current models of mechanisms of action in cognitive therapies .


To determine whether postaurical subcutaneous injection of triamcinolone acetonide is effective for subjective tinnitus refractory to medical treatment .


A total of 100 adult patients with subjective tinnitus of cochlear origin were randomly assigned to receive postaurical subcutaneous.Injection of either triamcinolone acetonide ( n = 50 ) or saline solution ( n = 50 ) .


The treatment protocol comprised 5 injections , one per week for 5 weeks.Improvement was measured by tinnitus severity evaluation index evaluation scale , at baseline and one week after the last injection .


The follow-up period was 6 months .


No significant difference existed between two groups regarding age , gender , pure tone average , pretreatment tinnitus intensity , tinnitus duration or hearing loss level tinnitus duration ( P = 0.316,0.685,0.839,0.682 and 0.881 respectively ) .


No significant post-treatment changes in the tinnitus severity index ( experimental group = 52 % , control group = 44 % ) were observed in either group ( P = 0.724 ) .


The most frequently encountered side effect was pain during injection .


The postaurical subcutaneous injection of triamcinolone acetonide has no obvious benefit compared with placebo for subjective tinnitus of cochlear origin refractory to medical treatment .


Multicentre radiotherapy clinical trials can incorporate quality assurance ( QA ) procedures for ensuring consistent application of the trial protocol in the planning , delivery and reporting of participant treatments .


Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy , although little has been shown for toxicity rates .


The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial .


Using QA records from the TROG 03.04 RADAR trial , the impact of variations on gastrointestinal ( GI ) and genito-urinary ( GU ) toxicities was investigated .


Protocol variation rates were lower than reported in previous studies , and showed little correlation with GI toxicity outcomes .


Variations classified as ` major ' showed a non-significant trend for increased toxicity relative to those classified as ` minor ' .


Results from a Level III phantom-based dosimetry study showed some correlation with GI toxicity , whereas ranking on a set-up accuracy study did not impact on toxicity .


Toxicity in general increased with the number of participants accrued per centre , at odds with previous reports relating to disease progression , with a potential link to increases in low-mid-range rectal doses in the cohort from higher-accruing centres .


No QA-related variables correlated with GU toxicities .


Besides non-significant trends , minimal association was observed between QA variables and toxicity rates for the RADAR trial .


The intention of the trial 's QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach .


The prevalence of vancomycin-associated nephrotoxicity ( VAN ) is reported to vary from 1.0-42 .6 % , with most data from critically ill patients .


Evaluation of VAN among internal medicine patients is lacking .


Our objectives were to determine the incidence , time-course , outcomes , and risk factors of VAN in adult internal medicine patients .


Retrospective cohort .


Tertiary care academic medical center .


A total of 125 adult internal medicine patients receiving vancomycin treatment with mean baseline creatinine clearance of 84.627.6 ml/min .


Vancomycin treatment for a minimum of 72hours .


Nephrotoxicity , defined as an increase in serum creatinine of 0.5 mg/dl or 50 % above baseline ( whichever was larger ) , occurred in 17 ( 13.6 % ) of 125 patients .


No patients with VAN progressed to Loss or End stage as defined by the RIFLE criteria .


The incidence rate of VAN was 0.02 cases/day of vancomycin treatment .


Nephrotoxicity developed at a median of 4.5 days ( interquartile range [ IQR ] 2.2-4 .9 ) peaked at 5.7 days ( IQR : 3.8-9 .6 ) , and resolved in 70.6 % of the cases within 16.5 days ( IQR : 6.0-17 .8 ) after onset .


On multivariable logistic regression analysis , after controlling for hypotensive episodes , Charlson Comorbidity Index , and baseline creatinine clearance , concomitant use of piperacillin-tazobactam was associated with increased VAN ( adjusted odds ratio 5.36 , 95 % confidence interval 1.41-20 .5 ) .


Vancomycin-associated nephrotoxicity is prevalent among internal medicine patients , with 5.36-fold higher odds if piperacillin-tazobactam is concomitantly administered .


To explore the prognostic and/or predictive value of human epidermal growth factor receptor 2 ( HER2 ) pathway-related biomarkers in the phase III CLEOPATRA study of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel as first-line treatment for patients with HER2-positive metastatic breast cancer .


Mandatory tumor and serum samples were collected ( N = 808 ; 58 % to 99.8 % were assessable ) , and amphiregulin , betacellulin , epidermal growth factor ( EGF ) , transforming growth factor alpha , EGF receptor , HER2 , HER3 , insulin-like growth factor 1 receptor , PTEN , phosphorylated AKT , PIK3CA , CMYC , serum HER2 extracellular domain ( sHER2 ) , and FCR were assessed using appropriate assays .


Two types of correlations were investigated using univariable Cox regression : predictive effects ( qualitative association of biomarkers with pertuzumab progression-free survival [ PFS ] benefit ) and prognostic effects independent of treatment arm ( relationship of each biomarker to clinical outcome in both arms pooled ) .


Pertuzumab consistently showed a PFS benefit , independent of biomarker subgroups ( hazard ratio < 1.0 ) , including estrogen receptor-negative and - positive subgroups .


High HER2 protein , high HER2 and HER3 mRNA levels , wild-type PIK3CA , and low sHER2 showed a significantly better prognosis ( P < .05 ) .


PIK3CA showed the greatest prognostic effect , with longer median PFS for patients whose tumors expressed wild-type versus mutated PIK3CA in both the control ( 13.8 v 8.6 months ) and pertuzumab groups ( 21.8 v 12.5 months ) .


Through comprehensive prospective analyses , CLEOPATRA biomarker data demonstrate that HER2 is the only marker suited for patient selection for the trastuzumab plus pertuzumab-based regimen in HER2-positive metastatic breast cancer .


HER2 , HER3 , and PIK3CA were relevant prognostic factors .


The goal of this study was to investigate the effects of linagliptin compared with glimepiride on alpha and beta cell function and several vascular biomarkers after a standardized test meal .


Thirty-nine patients on metformin alone ( age , 647years ; duration of type 2 diabetes mellitus , 7.84.5 years , 27 male , 12 female ; HbA1c , 57.26.9 mmol/mol ; meanSD ) were randomized to receive linagliptin 5mg ( n = 19 ) or glimepiride ( n = 20 ) for a study duration of 12weeks .


Glucagon-like peptide 1 , blood glucose , insulin , intact proinsulin , glucagon , plasminogen activator inhibitor-1 ( PAI-1 ) , cyclic guanosinmonophosphat and asymetric dimethylarginin levels were measured in the fasting state and postprandial at 30-min intervals for a duration of 5h .


The areas under the curve ( AUC0-300min ) were calculated for group comparisons .


HbA1c , fasting and postprandial glucose levels improved in both groups .


An increase in postprandial insulin ( 225955984pmol/L * min ) , postprandial intact proinsulin ( 1359658pmol/L * min ) , postprandial glucagon ( 3171136pg/mL * min ) and postprandial PAI-1 levels ( 863467ng/mL * min ) could be observed during treatment with glimepiride , whereas treatment with linagliptin was associated with a decrease in postprandial insulin ( -80074204 pmol/L * min ) , intact proinsulin ( -1771426 pmol/L * min ) , postprandial glucagon ( -15971831 pg/mL * min ) and PAI-1 levels ( -410276 ng/mL * min ) .


Despite an improvement in blood glucose control in both groups , linagliptin reduced postprandial insulin , proinsulin , glucagon and PAI-levels .


These results indicate an improvement in postprandial alpha and beta cell function , as well as a reduced postprandial vascular risk profile during treatment with linagliptin .


To explore the feasibility and safety of dexmedetomidine combined with remifentanil for lower eyelid blepharoplasty .


50 patients undergoing lower eyelid blepharoplasty ASA I - II were randomly divided into 2 groups ( 25 in each group ) as observation group and control group .


Dexmedetomidine ( 0.3 microg x kg ( -1 ) x h ( -1 ) ) and remifentanil ( 0.05 microg x kg ( -1 ) x min ( -1 ) ) were used in observation group .


Local anesthesia by lidocaine ( 1 % ) combined with midazolam ( 0.04 mg/kg ) intravenous sedation were used in control group .


HR , mean arterial pressure ( MAP ) , heart rate ( HR ) , breathing rate ( RR ) , pulse oxygen saturation ( SpO2 ) change were monitored and recorded before and after the administration of the drug , as well as at the beginning of operation , during the operation , at the end of the operation , and 5 minutes after the operation .


Patients sedation degree was evaluated by Ramsay .


Operation time , recovery time , the incidence of adverse reactions , the satisfaction of patients and doctors were also recorded .


Patients had no obvious difference of intraoperative MAP , RR , SpO2 , operation time and postoperative recovery time between the two groups ( P > 0.05 ) .


Compared with control group , HR during the operation were decreased significantly [ ( 64.2 + / - 8.2 ) bpm , P < 0.05 ] in observation group .


In control group , there were 18 cases of patients with agitation , but they endured the operation anyway .


In observation group , 24 cases of patients underwent operation without agitation .


The satisfaction of patients and the operation doctors ( 96 % ) in observation group were markedly higher than that in control group ( P < 0.05 ) .


Dexmedetomidine combined with remifentanil is practical and safe .


The effect of reducing HR should be noticed .


This study assessed efficacy of clarithromycin `` long-term '' macrolide therapy as an adjunct to maintenance therapy with nasal corticosteroids to prevent recurrence of nasal polyps ( NP ) after functional endoscopic sinus surgery ( FESS ) .


A total of 66 patients with chronic rhinosinusitis and bilateral NP were randomized into 3 study arms , 22 patients in each arm .


After FESS , patients in the first and second groups were treated with clarithromycin 250 mg/day for 12 and 24 weeks , respectively , whereas patients in the third group did not receive any clarithromycin .


Patients in all 3 groups received maintenance therapy with mometasone furoate 400 g/day .


Patient assessment was conducted before the surgery and 6 , 12 , and 24 weeks after surgery , using a visual analogue scale ( VAS ) , 20-item SinoNasal Outcome Test ( SNOT-20 ) , acoustic rhinometry , rhinomanometry , saccharin transit time , nasal endoscopy , computed tomography ( CT ) of paranasal sinuses , and measurement of the level of eosinophil cationic protein ( ECP ) in their nasal secretions .


The study confirmed efficacy of `` long-term '' macrolide therapy , resulting in significant improvement of all parameters except acoustic rhinometry and VAS in both clarithromycin groups as compared to the control .


Concentration of ECP in the nasal secretions increased dramatically after surgery , then returned to baseline levels after 12 and 24 weeks of treatment with clarithromycin .


In the control group , ECP level continued to increase and was significantly higher at the endpoint .


Both groups with clarithromycin showed significantly better endoscopic and CT scores than the control group at the end point .


`` Long-term '' low-dose clarithromycin 250 mg/day is able to control eosinophilic inflammation and prevent early relapse of NP after FESS .


The occurrence of ventilator-associated pneumonia ( VAP ) is linked to the aspiration of contaminated pharyngeal secretions around the endotracheal tube .


Tubes with cuffs made of polyurethane rather than polyvinyl chloride or with a conical rather than a cylindrical shape increase tracheal sealing .


To test whether using polyurethane and/or conical cuffs reduces tracheal colonization and VAP in patients with acute respiratory failure .


We conducted a multicenter , prospective , open-label , randomized study in four parallel groups in four intensive care units between 2010 and 2012 .


A cohort of 621 patients with expected ventilation longer than 2 days was included at intubation with a cuff composed of cylindrical polyvinyl chloride ( n = 148 ) , cylindrical polyurethane ( n = 143 ) , conical polyvinyl chloride ( n = 150 ) , or conical polyurethane ( n = 162 ) .


We used Kaplan-Meier estimates and log-rank tests to compare times to events .


After excluding 17 patients who secondarily refused participation or had met an exclusion criterion , 604 were included in the intention-to-treat analysis .


Cumulative tracheal colonization greater than 10 ( 3 ) cfu/ml at Day 2 was as follows ( median [ interquartile range ] ) : cylindrical polyvinyl chloride , 0.66 ( 0.58-0 .74 ) ; cylindrical polyurethane , 0.61 ( 0.53-0 .70 ) ; conical polyvinyl chloride , 0.67 ( 0.60-0 .76 ) ; and conical polyurethane , 0.62 ( 0.55-0 .70 ) ( P = 0.55 ) .


VAP developed in 77 patients ( 14.4 % ) , and postextubational stridor developed in 28 patients ( 6.4 % ) ( P = 0.20 and 0.28 between groups , respectively ) .


Among patients requiring mechanical ventilation , polyurethane and/or conically shaped cuffs were not superior to conventional cuffs in preventing tracheal colonization and VAP .


Clinical trial registered with clinicaltrials.gov ( NCT01114022 ) .


To evaluate the effects of the lactic acid bacterium Lactobacillus salivarius on caries risk factors .


The study was performed in 64 healthy volunteers to evaluate the effects of L. salivarius-containing tablets on caries risk factors .


The participants were divided randomly into four groups , and took tablets containing L. salivarius WB21 , L. salivarius TI 2711 , Ovalgen DC ( antibody against glucosyltransferase from Streptococcus mutans ) , or xylitol .


Levels of mutans streptococci and lactobacilli , amount of salivary flow , salivary pH , and salivary buffering capacity were assessed before and after taking the tablets .


Subsequently , a short-term administration trial using L. salivarius WB21-containing tablets was performed in eight healthy volunteers .


The participants took L. salivarius WB21-containing tablets ( 2.0 10 ( 9 ) colony forming units/day ) for 2 weeks , and the numbers of mutans streptococci in saliva were counted .


The levels of mutans streptococci seemed to decrease in the L. salivarius WB21 , TI 2711 , and Ovalgen DC groups compared to the xylitol group , with no significant differences between the groups .


Lactobacilli levels significantly increased in the L. salivarius WB21 and TI 2711 groups compared to the other groups .


Concerning salivary flow and salivary pH , no significant differences were observed between the groups .


The salivary buffering capacity significantly increased in the L. salivarius TI 2711 group ( P = 0.003 ) and Ovalgen DC group ( P = 0.002 ) compared to the xylitol group .


The short-term administration trial showed that the L. salivarius WB21-containing tablets significantly decreased the number of mutans streptococci ( P = 0.039 ) .


L. salivarius-containing tablets were suggested to increase resistance to caries risk factors .


UMIN000013160 ( registration date : February 14 , 2014 ) .


To examine the relationships between elevated depression symptoms ( EDS ) or stress and weight loss in SHINE , a telephonic , primary-care based , translation of the Diabetes Prevention Program .


N = 257 adults with metabolic syndrome were randomized to individual ( IC ) or group ( CC ) phone participation .


Weight , depression , anti-depressant use ( ADMs ) , and stress ( baseline , 6 months , 1 and 2 years ) were assessed .


Univariate analyses used linear and logistic regression , t tests for continuous variables and exact tests for categorical variables .


Stratified analyses assessed modifiers of effects of depression/stress on weight loss .


Approximately 35 % reported EDS , with no change over time .


Approximately 28 % of all participants used ADMs .


Participants with EDS had lower mean % weight loss and a smaller % who achieved 5 % weight loss .


Participants with EDS were less likely to be `` completers '' ( 40.1 % vs. 61.5 % , P = 0.002 ) , coached ( 48.0 % vs. 60.7 % , P = 0.049 ) , or log diet/activity ( 19.4 % vs. 42.7 % , P < 0.001 ) , behaviors related to weight loss .


Results were similar for high stress .


ADM use had no independent effect on weight loss .


Individuals with metabolic syndrome and EDS and/or high stress were less likely to lose significant weight .


Pre-intervention depression and stress screening to intervene may improve weight loss .


This subanalysis aimed to clarify whether intensive lipid-lowering therapy with statins slows the progression of atherosclerosis in Japanese subjects under treatment for primary prevention of cardiovascular disease .


This was a subanalysis of the Justification for Atherosclerosis Regression Treatment ( JART ) Study .


We compared the efficacy of intensive lipid-lowering therapy and conventional therapy with respect to changes in the mean intima-media thickness ( IMT ) and serum lipid levels .


We also evaluated changes in the mean IMT over 24 months of treatment and assessed the relationship between these changes and reductions in the LDL-C levels using a post-hoc analysis .


Intensive lipid-lowering therapy with rosuvastatin was associated with significantly smaller changes in the mean IMT and a greater reduction in the serum lipid levels in comparison to conventional therapy with pravastatin .


The average net change in the mean IMT was 0.010 mm ( n = 121 ) at 12 months and -0.004 mm ( n = 56 ) at 24 months .


A decrease in LDL-C was found to be associated with a smaller change in the mean IMT ( p = 0.0009 ; Jonckheere-Terpstra trend test ) .


A greater reduction in serum LDL-C was found to be associated with a smaller change in the mean IMT .


Similar associations were observed for the serum TC and non-HDL-C levels and LDL-C/HDL-C ratio .


There were no notable differences in the incidence of serious adverse events among the LDL-C quartiles .


Lowering the LDL-C level with intensive lipid-lowering therapy is associated with reduced changes in the IMT among Japanese subjects at moderate to high risk under treatment for primary prevention .


Subjects suitable for primary prevention may receive cardiovascular benefits from intensive lipid-lowering therapy , in association with significantly slower IMT progression than that observed with conventional therapy .


Fluticasone propionate and nasal saline irrigation have been used in the treatment of sinonasal diseases for a long time .


Our study investigates the effect of the combination of large volume low pressure nasal saline irrigation and fluticasone propionate for the treatment of pediatric acute rhinosinusitis .


Ninety-one pediatric patients with acute rhinosinusitis were included in our study .


The patients were randomized into two groups .


The first group ( n = 45 ) was treated with standard therapy ( antibiotherapy + nasal decongestant ) for 2 weeks , the second group was treated with the large volume low pressure nasal saline + fluticasone propionate combination for 3 weeks .


The clinical scores , radiologic evaluations ( X-ray Waters view ) , peak nasal inspiratory flow ( PNIF ) measurements , total symptom scores and hematologic parameters ( WBC , CRP , ESR ) of the patients were evaluated and compared .


There were no significant differences in between the two groups regarding age , gender , height and weight .


Even though the clinical scores of Group 2 improved more rapidly , there were no significant differences in between groups regarding clinical scores by the 21st day .


There were no significant differences in post treatment radiologic evaluations ( Waters graphy ) .


Both groups had significant improvement of their post treatment PNIF values , yet the improvement was more marked in Group 2 than in Group 1 .


The rhinorrhea , nasal congestion , throat itching and cough symptoms improved more rapidly in Group 2 than in Group 1 .


Post-treatment nose itching and sneezing symptoms were significantly less in Group 2 .


The values of hematologic parameters were significantly reduced at the end of the 3rd week in both groups .


Our study is a first in investigating the combined use of large volume low pressure nasal saline and fluticasone propionate in acute pediatric rhinosinusitis , and the results reveal that the combination therapy was effective .


Low pressure large volume nasal saline + fluticasone propionate combination can be employed as a new line of therapy for the treatment of pediatric acute rhinosinusitis , either by itself or combined with standard therapy .


Cyclosporine and tacrolimus ( TAC ) are the most potent immunosuppressants .


TAC is considered less nephrotoxic , but may be an important factor in chronic graft dysfunction .


The aim of the study was to evaluate kidney function and cardiovascular risk profile in 2 groups of low immunological risk kidney allograft recipients receiving 2 TAC dosages .


Patients were randomly assigned to 2 TAC-based treatments ( group I [ n = 14 ] , standard dose ; group II [ n = 15 ] , reduced dose ) .


Patient and graft survival , graft function , occurrence of cardiovascular events ( cardiac death , myocardial infarction , stroke ) , incidence of new-onset diabetes mellitus after transplantation , and cardiovascular risk factors were assessed over a 5-year period .


Patient demographics and transplant characteristics were not statistically different between groups .


TAC trough levels were significantly higher in group I for 24 months post transplant .


Patient survival did not differ , but there were more acute rejection episodes and graft losses in group II .


There were no significant differences in the rate of cardiac events .


Graft function measured as serum creatinine levels and calculated glomerular filtration rate did not differ between groups .


The same applies to new-onset diabetes mellitus after transplantation incidence .


Office blood pressures were numerically higher in group I up to 24 months but this difference did not reach significance at any time .


Similar results were obtained for serum lipids .


Immunosuppression based on low doses of tacrolimus seems to be safe in the group of low immunological risk patients but in the 60-month follow-up does not offer any clear benefits in terms of potential nephrotoxicity or cardiovascular risk .


This randomized controlled trial examined the quality-of-life benefits of an expressive writing ( EW ) intervention for patients with renal cell carcinoma ( RCC ) and identified a potential underlying mechanism of intervention efficacy .


Patients ( N = 277 ) with stage I to IV RCC were randomly assigned to write about their deepest thoughts and feelings regarding their cancer ( EW ) or about neutral topics ( neutral writing [ NW ] ) on four separate occasions .


Patients completed the Center for Epidemiologic Studies Depression Scale ( CES-D ) , MD Anderson Symptom Inventory ( MDASI ) , Brief Fatigue Inventory ( BFI ) , Pittsburgh Sleep Quality Index ( PSQI ) , Medical Outcomes Study Short Form-36 ( SF-36 ) , and Impact of Event Scale ( IES ) at baseline and 1 , 4 , and 10 months after the intervention .


The mean age of participants ( 28 % stage IV ; 41 % female ) was 58 years .


Multilevel modeling analyses , using a Bonferroni-corrected = .021 for six outcomes adjusted for the correlation among outcomes , revealed that , relative to the NW group , patients in the EW group reported significantly lower MDASI scores ( P = .003 ) and higher physical component summary scores on the SF-36 ( P = .019 ) at 10 months after the intervention .


Mediation analyses revealed that significant group differences for MDASI scores at 10 months were mediated by lower IES scores at 1 month after the intervention in the EW group ( P = .042 ) .


No significant group differences were observed in the BFI , CES-D , PSQI , and mental component summary of the SF-36 .


EW may reduce cancer-related symptoms and improve physical functioning in patients with RCC .


Evidence suggests that this effect may occur through short-term improvements in cognitive processing .


To compare two different impression techniques for implants in totally edentulous patients .


A total of 38 patients had impressions taken both using plaster and splinted vinyl polysiloxane ( splinted-VPS ) .


Two casts per patient were generated and allocated as test ( plaster ) and control ( splinted-VPS ) cast groups according to a randomised cross-over design .


One of the two casts from each patient was randomly selected as master cast according to a parallelgroup design and used to fabricate the definitive prosthesis .


Outcome measures were implant and prosthetic success rates , complications , marginal bone level ( MBL ) changes , patient satisfaction , chair time required to take the impressions , inter-implant discrepancy between the casts , sulcus bleeding index ( SBI ) and plaque score ( PS ) .


In total , 76 impressions were taken in 38 patients .


Two plaster impressions failed .


Furthermore , 38 computer-aided design/computer-assisted manufacturing screw-retained complete-arch prostheses were fabricated onto the master cast ( 18 from plaster and 20 from splinted-VPS impressions ) and the patients were followed up for 3 years after loading .


No drop-out occurred and no implants or prostheses failed , accounting for a cumulative implant and prosthesis survival rate of 100 % over the 3-year post-loading period .


Plaster impressions yielded significantly greater patient satisfaction and shorter chair time .


The discrepancy between the casts was 0.055 0.067 mm ( P = 0.931 ) .


Mixed model analysis revealed a significant main effect from both the implant number and the inter-implant distance , while no difference was found with regard to implant angulation .


Five chip-off fractures of the porcelain veneer occurred in 5 of the 38 patients ( 3 in restorations fabricated onto the plaster cast group and 2 in the splinted-VPS cast group ) with no effect from the type of impression on the prosthetic success rate ( P = 0.331 ) .


However , all of the patients were functionally and aesthetically satisfied with their prostheses .


Furthermore , mean MBL , SBI and PS showed no significant differences ( P > 0.05 ) between the groups .


The clinical outcome of plaster impressions for completely edentulous patients was found to be the same as that for splinted-VPS impressions .


The intraoral pre-scan resin framework try-in can be avoided .


Plaster impressions may be less time consuming and thus more comfortable for the patient , but sometimes may have to be repeated due to fractures .


All materials used in this study were purchased by the authors and there were no commercial or institutional interests .


Prospective randomized single blind study .


To find out the incidence of deep vein thrombosis ( DVT ) in Indian acute spinal cord injury ( ASCI ) subjects with and without pharmacological prophylaxis .


Indian Spinal Injuries Centre .


Seventy four ASCI subjects were randomly divided into two groups with 37 subjects each : group I received no antithrombotic prophylaxis , and only physical measures like compression stockings were employed for prophylaxis , whereas group II received antithrombotic prophylaxis with low-molecular weight heparin ( LMWH ) along with physical measures as in group I. DVT was monitored through daily clinical assessment and doppler venous ultrasonography at 2 weeks .


Out of 37 subjects in each group , eight ( 21.6 % ) developed DVT in group I and two ( 5.4 % ) in group II .


The difference was significant ( P-value = 0.041 ) .


Six out of eight subjects who developed DVT in group I were asymptomatic .


There was no incidence of significant DVT-related complications including pulmonary embolism in any of the subjects .


There is a significant incidence of DVT in Indian subjects with ASCI but definitely less than what has been reported in western literature .


Pharmacological prophylaxis ( LMWH in this study ) significantly ( P = 0.041 ) decreases the incidence of DVT in subjects with ASCI .


As there was no difference in the incidence of symptomatic DVT or related complications , a larger study would be required to conclude definitely on the role of pharmacological prophylaxis in the Indian population .


Describe the effects of conjugated estrogens/bazedoxifene ( CE/BZA ) , a new treatment for vasomotor symptoms ( VMS ) and osteoporosis prevention , on menopause-specific quality of life ( MSQOL ) across different patient population types in phase 3 clinical trials .


MSQOL was prospectively evaluated in 4 randomized , double-blind , placebo-controlled studies .


The populations studied included healthy , non-hysterectomized postmenopausal women with symptomatic VMS or vulvar-vaginal atrophy ( VVA ) and general postmenopausal women ( eligible regardless of symptoms ) .


Menopause-specific Quality of Life ( MENQOL ) questionnaire total and domain scores for CE 0.625 mg/BZA 20mg and CE 0.45 mg/BZA 20mg were evaluated and compared with established thresholds for clinically important differences ( CID ) .


Significant improvements compared with placebo were found with both CE/BZA doses in MENQOL vasomotor domain ( -0.61 to -2.23 over 3-24 months ) and total scores ( -0.24 to -0.94 ) in the general and symptomatic VMS/VVA populations .


Significant improvement compared with placebo in sexual domain ( -0.11 to -0.72 ) was observed with the higher dosage for all populations , and with the lower dosage in the VVA ( -0.71 at month 3 ) and general populations ( -0.4 at months 12 and 24 ) .


Improvements in vasomotor domain exceeded the CID with both doses in symptomatic VMS populations and with the higher dosage in women with symptomatic VVA ; for total MENQOL , the CID was exceeded with the higher dose in symptomatic VMS populations .


CE/BZA significantly improved overall and vasomotor-related MSQOL across populations of postmenopausal women with varying baseline symptom statuses .


Women with greater menopausal symptoms at baseline were more likely to experience clinically meaningful changes .


Intradialytic hypotension ( IDH ) represents a common hemodialysis ( HD ) complication .


Blood volume tracking ( BVT ) is a tool regulating the relative blood volume changes and potentially reducing the occurrence of IDH .


The aim of this study was to evaluate the ability of BVT to reduce the staff workload associated to IDH .


Ten hypotension-prone HD patients were treated each with 39 conventional HD ( HD ) sessions and then switched to 39 HD sessions with BVT ( HD-BVT ) .


The staff interventions related to IDH were monitored by a trained staff .


Dialysis sessions complicated by IDH and staff interventions were affected by BVT ( HD : 102 and 127 vs. HD-BVT : 57 and 59 , respectively , for both p < 0.001 ) .


The time consumed by staff in IDH management was decreased by HD-BVT ( 1416 vs. 578 min , p < 0.001 ) .


The effectiveness of BVT to reduce the frequency of IDH leads to a reduction of the dialysis staff workload with fewer staff interventions , allowing for major work-time saving .


To examine the impact of blood pressure control on hospital health resource utilization using data from the ECLIPSE trials .


Post-hoc analysis of data from 3 prospective , open-label , randomized clinical trials ( ECLIPSE trials ) .


Sixty-one medical centers in the United States .


Patients 18 years or older undergoing cardiac surgery .


Clevidipine was compared with nitroglycerin , sodium nitroprusside , and nicardipine .


The ECLIPSE trials included 3 individual randomized open-label studies comparing clevidipine to nitroglycerin , sodium nitroprusside , and nicardipine .


Blood pressure control was assessed as the integral of the cumulative area under the curve ( AUC ) outside specified systolic blood pressure ranges , such that lower AUC represents less variability .


This analysis examined surgery duration , time to extubation , as well as intensive care unit ( ICU ) and hospital length of stay ( LOS ) in patients with AUC10 mmHgmin/h compared to patients with AUC > 10 mmHgmin/h .


One thousand four hundred ten patients were included for analysis ; 736 patients ( 52 % ) had an AUC10 mmHgmin/h , and 674 ( 48 % ) had an AUC > 10 mmHgmin/h .


The duration of surgery and ICU LOS were similar between groups .


Time to extubation and postoperative LOS were both significantly shorter ( p = 0.05 and p < 0.0001 , respectively ) in patients with AUC10 .


Multivariate analysis demonstrates AUC10 was significantly and independently associated with decreased time to extubation ( hazard ratio 1.132 , p = 0.0261 ) and postoperative LOS ( hazard ratio 1.221 , p = 0.0006 ) .


Based on data derived from the ECLIPSE studies , increased perioperative BP variability is associated with delayed time to extubation and increased postoperative LOS .


We assessed the likelihood of 12-month seizure remission and treatment failure after failure of a first antiepileptic drug , and identified factors influencing these outcomes .


SANAD ( Standard and New Antiepileptic Drug ) was a randomized controlled trial comparing monotherapy with standard and new antiepileptic drugs .


Patients were followed up to study completion , even if they were switched from their randomized treatment .


After a first treatment failure , we assessed the probability of 12-month seizure remission and treatment failure .


Prognostic modeling identified predictors of these outcomes .


Forty-four percent of patients in the SANAD trial had a first treatment failure .


Seventy-five percent of these subsequently achieved 12-month remission by 6 years of follow-up .


Significant prognostic factors included sex , age at treatment failure , time on randomized treatment at treatment failure , neurologic insult , total number of tonic-clonic seizures at treatment failure , reason for treatment failure , seizure type , and CT/MRI scan result .


After a first treatment failure , young patients without tonic-clonic seizures , with a normal CT/MRI scan and failing their treatment because of unacceptable adverse events , had the highest likelihood of 12-month remission .


Approximately 50 % of patients who failed a first treatment also failed their second .


Significant prognostic factors included total number of tonic-clonic seizures at first treatment failure , reason for first treatment failure , and CT/MRI scan result .


Patients with tonic-clonic seizures and failing because of inadequate seizure control had the highest risk of a second treatment failure .


A high proportion of patients will achieve 12-month remission after a first treatment failure .


Clinical factors can stratify patients according to likely outcome .


Preoperative quantitative assessment of glenoid bone loss , selection of the glenoid component , and definition of its desired location can be challenging .


Placement of the glenoid component in the desired location at the time of surgery is difficult , especially with severe glenoid pathological conditions .


Forty-six patients were randomly assigned to three-dimensional computed tomographic preoperative templating with either standard instrumentation or with patient-specific instrumentation and were compared with a nonrandomized group of seventeen patients with two-dimensional imaging and standard instrumentation used as historical controls .


All patients had postoperative three-dimensional computed tomographic metal artifact reduction imaging to measure and to compare implant position with the preoperative plan .


Using three-dimensional imaging and templating with or without patient-specific instrumentation , there was a significant improvement achieving the desired implant position within 5 of inclination or 10 of version when compared with two-dimensional imaging and standard instrumentation .


Three-dimensional assessment of glenoid anatomy and implant templating and the use of these images at the time of surgery improve the surgeon 's ability to place the glenoid implant in the desired location .


In recent years , there has been a growing body of evidence indicating that replacing cholecalciferol ( vitamin D ) with 25-hydroxycholecalciferol [ 25 ( OH ) D ] through dietary supplementation enhances breast meat yield in broiler chickens .


However , the underlying molecular mechanisms are still unknown .


We investigated the effect of 25 ( OH ) D on male broiler growth performance ( body weight , feed intake , feed conversion ratio , and breast meat yield ) , muscle protein synthesis , and the potential underlying molecular mechanisms .


Male Cobb 500 broiler chickens were divided into 4 body weight-matched groups and received a control diet with normal cholecalciferol ( 2760 IU/kg feed ) for 42 d , a diet with high concentrations of cholecalciferol ( 5520 IU/kg feed ) for 42 d , or a diet with 25 ( OH ) D ( 5520 IU/kg feed ) for 42 d ( HyD-42 ) .


A fourth group consumed the HyD-42 for 21 d and then control feed for 21 d ( HyD-21 ) ( n = 360 birds , 12 replicates/treatment ) .


Food and clean water were available for ad libitum consumption .


At the end of the 42-d experiment , protein turnover was measured by phenylalanine flooding dose .


Breast muscle tissues were collected and protein synthesis-related gene and protein expression were measured by real time polymerase chain reaction and Western blot , respectively .


Functional studies were performed in vitro with the use of a quail myoblast ( QM7 ) cell line .


QM7 cells were treated with 2 doses ( 1 nM and 10 nM ) of cholecalciferol or 25 ( OH ) D alone or in combination with 100 nM rapamycin , and cell proliferation was determined by cell proliferation assay .


Protein synthesis-related gene and protein expression were also determined .


The HyD-42 increased 25 ( OH ) D circulating concentrations by 126 % ( P < 0.05 ) , enhanced breast meat yield ( P < 0.05 ) , and increased the fractional rate of protein synthesis by 3-fold ( P < 0.05 ) compared with the control diet .


Molecular analyses revealed that breast muscle from chickens consuming the HyD-42 expressed significantly higher concentrations of vitamin D receptor ( VDR ) , phospho mechanistic target of rapamycin ( Ser2481 ) , phospho ribosomal P70 S6 kinase ( RPS6K ) ( Thr421/Ser424 ) , and antigen Ki-67 ( Ki67 ) compared with the other groups .


In line with the in vivo data , in vitro functional studies showed that cells treated with 25 ( OH ) D for 24 h had increased VDR expression , and activated the mechanistic target of rapamycin ( mTOR ) / S6 kinase ( S6K ) pathway , enhanced Ki67 protein concentrations , and induced QM7 cell proliferation compared with untreated or cholecalciferol-treated cells .


Blocking the mTOR pathway with rapamycin reversed these effects .


Taken together , our findings provide evidence that the effects of 25 ( OH ) D on male broiler breast muscle are likely mediated through the mTOR-S6K pathway .


To assess the influence of an infusion of clonidine 1 g/kg/hr on fentanyl and midazolam requirement in ventilated newborns and infants .


Prospective , double-blind , randomized controlled multicenter trial .


Controlled trials.com/ISRCTN77772144 .


Twenty-eight level 3 German PICUs/neonatal ICUs .


Ventilated newborns and infants : stratum I ( 1-28 d ) , stratum II , ( 29-120 d ) , and stratum III ( 121 d to 2 yr ) .


Patients received clonidine 1 g/kg/hr or placebo on day 4 after intubation .


Fentanyl and midazolam were adjusted to achieve a defined level of analgesia and sedation according to Hartwig score .


Two hundred nineteen infants were randomized ; 212 received study medication , 69.7 % were ventilated in the postoperative care and 30.3 % for other reasons .


Primary endpoint : consumption of fentanyl and midazolam in the 72 hours following the onset of study medication ( main observation period ) in the overall study population .


The confirmatory analysis of the overall population showed no difference in the consumption of fentanyl and midazolam .


Explorative age-stratified analysis demonstrated that in stratum I ( n = 112 ) the clonidine group had a significantly lower consumption of fentanyl ( clonidine : 2.1 1.8 g/kg/hr , placebo : 3.2 3.1 g/kg/hr ; p = 0.032 ) and midazolam ( clonidine : 113.0 100.1 g/kg/hr , placebo : 180.2 204.0 g/kg/hr ; p = 0.030 ) .


Strata II ( n = 43 ) and III ( n = 46 ) showed no statistical difference .


Sedation and withdrawal-scores were significantly lower in the clonidine group of stratum I ( p < 0.001 ) .


Frequency of severe adverse events did not differ between groups .


Clonidine 1 g/kg/hr in ventilated newborns reduced fentanyl and midazolam demand with deeper levels of analgesia and sedation without substantial side effects .


This was not demonstrated in older infants , possibly due to lower clonidine serum levels .


To investigate the effects of body awareness therapy on balance , mobility , balance confidence , and subjective health status in persons with stroke .


A pilot randomized controlled study with follow-up at one and 4-6 weeks after the intervention period .


Four primary healthcare centres in rebro County Council .


Persons more than six months post stroke , with walking ability of 100 metres .


The experimental intervention was body awareness therapy in groups once a week for eight weeks .


The controls were instructed to continue their usual daily activities .


Berg Balance Scale , Timed Up and Go Test , Timed Up and Go Test with a cognitive component , 6-minute walk test , and Timed-Stands Test .


Self-rated balance confidence was assessed using the Activities-specific Balance Confidence Scale , and subjective health status using the Short Form 36 ( SF-36 ) questionnaire .


A total of 46 participants were included ( mean age 64 years ) ; 24 in the experimental intervention group and 22 in the control group .


No significant differences in changed scores over time were found between the groups .


Within the experimental intervention group , significant improvements over time was found for the tests Berg Balance Scale , Timed Up and Go cognitive , and 6-minute walk test .


Within the control group , significant improvements over time were found for the Timed Up and Go Cognitive , and the Timed-Stands Test .


In comparison to no intervention , no effects were seen on balance , mobility , balance confidence , and subjective health status after eight weeks of body awareness therapy .


Major depressive disorder ( MDD ) imposes a considerable disease burden on individuals and societies .


A large number of randomised controlled trials ( RCTs ) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression .


However , study quality varies considerably .


The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention ( GET.ON Mood Enhancer ) compared to online-based psychoeducation in an investigator-blinded RCT .


A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression ( OPD ) .


Both treatment groups will have full access to treatment as usual .


Adults with MDD ( n = 128 ) will be recruited and randomised to one of the two conditions .


Primary outcome will be observer-rated depressive symptoms ( HRSD-24 ) by independent assessors blind to treatment conditions .


Secondary outcomes include changes in self-reported depressive symptom severity , anxiety and quality of life .


Additionally , potential negative effects of the treatments will systematically be evaluated on several dimensions ( for example , symptom deteriorations , attitudes toward seeking psychological help , relationships and stigmatisation ) .


Assessments will take place at baseline , 6 and 12 weeks after randomisation .


This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition ( psychoeducation-control ) and an independent , blinded outcome evaluation .


This study will further enhance the evidence for Internet-based guided self-help interventions for MDD .


German Clinical Trial Registration ( DRKS ) : DRKS00005025 .


Novel strategies are needed to increase the uptake of voluntary medical male circumcision ( VMMC ) in sub-Saharan Africa and enhance the effectiveness of male circumcision as an HIV prevention strategy .


To determine whether small economic incentives could increase circumcision prevalence by addressing reported economic barriers to VMMC and behavioral factors such as present-biased decision making .


Randomized clinical trial conducted between June 22 , 2013 , and February 4 , 2014 , among 1504 uncircumcised men aged 25 to 49 years in Nyanza region , Kenya .


VMMC services were provided free of charge and participants were randomized to 1 of 3 intervention groups or a control group .


Participants in the 3 intervention groups received varying amounts of compensation conditional on undergoing circumcision at 1 of 9 study clinics within 2 months of enrollment .


Compensation took the form of food vouchers worth 200 Kenya shillings ( US $ 2.50 ) , 700 Kenya shillings ( US $ 8.75 ) , or 1200 Kenya shillings ( US $ 15.00 ) , which reflected a portion of transportation costs and lost wages associated with getting circumcised .


The control group received no compensation .


VMMC uptake within 2 months .


Analysis of data for 1502 participants with complete data showed that VMMC uptake within 2 months was higher in the US $ 8.75 group ( 6.6 % ; 95 % CI , 4.3 % -9.5 % [ 25 of 381 ] ) and the US $ 15.00 group ( 9.0 % ; 95 % CI , 6.3 % -12.4 % [ 34 of 377 ] ) than in the US $ 2.50 group ( 1.9 % ; 95 % CI , 0.8 % -3.8 % [ 7 of 374 ] ) and the control group ( 1.6 % ; 95 % CI , 0.6 % -3.5 % [ 6 of 370 ] ) .


In logistic regression analysis , the US $ 8.75 group had significantly higher VMMC uptake than the control group ( adjusted odds ratio [ AOR ] 4.3 ; 95 % CI , 1.7-10 .7 ) , as did the US $ 15.00 group ( AOR 6.2 ; 95 % CI , 2.6-15 .0 ) .


Effect sizes for the US $ 8.75 and US $ 15.00 groups did not differ significantly ( P = .20 ) .


Among uncircumcised men in Kenya , compensation in the form of food vouchers worth approximately US $ 8.75 or US $ 15.00 , compared with lesser or no compensation , resulted in a modest increase in the prevalence of circumcision after 2 months .


The effects of more intense promotion or longer implementation require further investigation .


clinicaltrials.gov Identifier : NCT01857700 .


Key factors limiting patients with lower extremity amputations to achieve maximal functional capabilities are falls and fear of falling .


A task-specific fall prevention training program has successfully reduced prospectively recorded trip-related falls that occur in the community by the elderly .


However , this program has not been tested in amputees .


In a cohort of unilateral transtibial amputees , we aimed to assess effectiveness of a falls prevention training program by ( 1 ) quantifying improvements in trunk control ; ( 2 ) measuring responses to a standardized perturbation ; and ( 3 ) demonstrating retention at 3 and 6 months after training .


Second , we collected patient-reported outcomes for balance confidence and falls control .


Fourteen male military service members ( 26 3 years ) with unilateral transtibial amputations and who had been walking without an assistive device for a median of 10 months ( range , 2-106 months ) were recruited to participate in this prospective cohort study .


The training program used a microprocessor-controlled treadmill designed to deliver task-specific postural perturbations that simulated a trip .


The training consisted of six 30-minute sessions delivered over a 2-week period , during which task difficulty , including perturbation magnitude , increased as the patient 's ability progressed .


Training effectiveness was assessed using a perturbation test in an immersive virtual environment .


The key outcome variables were peak trunk flexion and velocity , because trunk kinematics at the recovery step have been shown to be a determinant of fall likelihood .


The patient-reported outcomes were also collected using questionnaires .


The effectiveness of the rehabilitation program was also assessed by collecting data before perturbation training and comparing the key outcome parameters with those measured immediately after perturbation training ( 0 months ) as well as both 3 and 6 months posttraining .


Mean trunk flexion angle and velocity significantly improved after participating in the training program .


The prosthetic limb trunk flexion angle improved from pretraining ( 42 ; 95 % confidence interval [ CI ] , 38-47 ) to after training ( 31 ; 95 % CI , 25-37 ; p < 0.001 ) .


Likewise , the trunk flexion velocity improved from pretraining ( 187/sec ; 95 % CI , 166-209 ) to after training ( 143/sec ; 95 % CI , 119-167 ; p < 0.004 ) .


The results display a significant side-to-side difference for peak trunk flexion angle ( p = 0.01 ) with perturbations of the prosthetic limb resulting in higher peak angles .


Prosthetic limb trips also exhibited significantly greater peak trunk flexion velocity compared with trips of the prosthetic limb ( p = 0.005 ) .


These changes were maintained up to 6 months after the training .


The peak trunk flexion angle of the subjects when the prosthetic limb was perturbed had a mean of 31 ( 95 % CI , 25-37 ) at 0 month , 32 ( 95 % CI , 28-37 ) at 3 months , and 30 ( 95 % CI , 25-34 ) at 6 months .


Likewise , the peak trunk flexion velocity for the prosthetic limb was a mean of 143/sec ( 95 % CI , 118-167 ) at 0 months , 143/sec ( 95 % CI , 126-159 ) at 3 months , and 132 ( 95 % CI , 115-149 ) at 6 months .


The peak trunk flexion angle when the nonprosthetic limb was perturbed had a mean of 22 ( 95 % CI , 18-24 ) at 0 months , a mean of 26 ( 95 % CI , 20-32 ) at 3 months , and a mean of 23 ( 95 % CI , 19-28 ) at 6 months .


The peak trunk flexion velocity for the nonprosthetic limb had a mean of 85/sec ( 95 % CI , 71-98 ) at 0 months , a mean of 96 ( 95 % CI , 68-124 ) at 3 months , and 87/sec ( 95 % CI , 68-105 ) at 6 months .


There were no significant changes in the peak trunk flexion angle ( p = 0.16 ) or peak trunk flexion velocity ( p = 0.35 ) over time after the training ended .


The skill retention was present when either the prosthetic or nonprosthetic limb was perturbed .


There were side-to-side differences in the trunk flexion angle ( p = 0.038 ) and trunk flexion velocity ( p = 0.004 ) .


Perturbations of the prosthetic side resulted in larger trunk flexion and higher trunk flexion velocities .


Subjects prospectively reported decreased stumbles , semicontrolled falls , and uncontrolled falls .


These results indicate that task-specific fall prevention training is an effective rehabilitation method to reduce falls in persons with lower extremity transtibial amputations .


To explore the optimal postoperative nutritional support in elderly patients with gastric cancer .


One hundred and twenty elderly patients with gastric cancer undergoing radical gastrectomy were prospectively enrolled from January 2010 to March 2013 and randomly divided into total parenteral nutrition group ( TPN , n = 40 ) , early total enteral nutrition group ( TEN , n = 40 ) and enteral plus parenteral nutrition group ( EN+PN , n = 40 ) .


Clinical charasteristics including treatment tolerance , nutritional indexes , immune indexes , time to first flatus , incidence of postoperative infection and anastomotic leakage , were analyzed and compared .


Treatment tolerance in EN+PN group ( 97.5 % , 39/40 ) was significantly higher than that in TPN group ( 82.5 % , 33/40 ) and TEN group ( 80.0 % , 32/40 ) ( both P < 0.05 ) .


The nutritional indices , including prealbumin , albumin , transferrin , body mass index , and the incidence of anastomotic leakage were similar in the 3 groups ( P > 0.05 ) .


The immune indices , including CD3 , CD4 , CD4/CD8 , were significantly reduced after operation in each group .


However , they were significantly higher in EN+PN group and TEN group than those in TPN group ( both P < 0.05 ) .


Furthermore , compared to the TPN group , the incidence of postoperative infection ( surgical site infection , pulmonary infection , abdominal infection ) was significantly lower and time to first flatus was significantly shorter in EN+PN group and TEN group .


Early enteral nutrition after gastric cancer surgery is safe , simple and feasible .


EN plus PN is the best way to administer postoperative nutritional support in elderly patients with gastric cancer .


Integrins are involved in tumour progression and metastasis , and differentially expressed on colorectal cancer ( CRC ) cells .


Abituzumab ( EMD 525797 ) , a humanised monoclonal antibody targeting integrin heterodimers , has demonstrated preclinical activity .


This trial was designed to assess the tolerability of different doses of abituzumab in combination with cetuximab and irinotecan ( phase I ) and explore the efficacy and tolerability of the combination versus that of cetuximab and irinotecan in patients with metastatic CRC ( mCRC ) ( phase II part ) .


Eligible patients had KRAS ( exon 2 ) wild-type mCRC and had received prior oxaliplatin-containing therapy .


The trial comprised an initial safety run-in using abituzumab doses up to 1000 mg combined with a standard of care ( SoC : cetuximab plus irinotecan ) and a phase II part in which patients were randomised 1 : 1 : 1 to receive abituzumab 500 mg ( arm A ) or 1000 mg ( arm B ) every 2 weeks combined with SoC , or SoC alone ( arm C ) .


The primary end point was investigator-assessed progression-free survival ( PFS ) .


Secondary end points included overall survival ( OS ) , response rate ( RR ) and tolerability .


Associations between tumour integrin expression and outcomes were also assessed .


Phase I showed that abituzumab doses up to 1000 mg were well tolerated in combination with SoC .


Seventy-three ( arm A ) , 71 ( arm B ) and 72 ( arm C ) patients were randomised to the phase II part .


Baseline characteristics were balanced .


PFS was similar in the three arms : arm A versus SoC , hazard ratio ( HR ) 1.13 [ 95 % confidence interval ( CI ) 0.78-1 .64 ] ; arm B versus SoC , HR 1.11 ( 95 % CI 0.77-1 .61 ) .


RRs were also similar .


A trend toward improved OS was observed : arm A versus SoC , HR 0.83 ( 95 % CI 0.54-1 .28 ) ; arm B versus SoC , HR 0.80 ( 95 % CI 0.52-1 .25 ) .


Grade 3 treatment-emergent adverse events were observed in 72 % , 78 % and 67 % of patients .


High tumour integrin v6 expression was associated with longer OS in arms A [ HR 0.55 ( 0.30-1 .00 ) ] and B [ HR 0.41 ( 0.21-0 .81 ) ] than in arm C.


The primary PFS end point was not met , although predefined exploratory biomarker analyses identified subgroups of patients in whom abituzumab may have benefit .


The tolerability of abituzumab combined with cetuximab and irinotecan was acceptable .


Further study is warranted .


CLINICALTRIALS.GOV IDENTIFIER : NCT01008475 .


To investigate whether remote ischemic conditioning ( RIC ) can attenuate ischemic reperfusion injury ( IRI ) in recipients after kidney transplantation using donation after cardiac death .


Forty-eight recipients referred for kidney transplantation were recruited .


The paired recipients who received the kidneys from the same donor were randomly assigned ( one received RIC and the other did not ) .


RIC was induced by three 5-min cycles of brief repetitive ischemia and reperfusion by clamping the exposed external iliac artery .


Blood samples were withdrawn at hour 2 , hour 12 , days 1-7 , day 14 , and day 30 to measure serum creatinine level and estimated glomerular filtration rate after transplantation .


Urine samples were collected at hours 2 , 12 , 24 , and 48 to measure urine neutrophil gelatinase-associated lipocalin after transplantation .


Renal tissues were obtained at 30min for histologic changes after transplantation .


There were no significant differences in clinical characteristics of the recipients and donors between RIC and control groups .


The serum creatinine level was lower in the RIC group compared with that of the control group ( 12h , days 1-14 , P < 0.05 ; other P > 0.05 ) ; the estimated glomerular filtration rate was higher in the RIC group compared with that of the control group ( 12h , days 1-14 , P < 0.05 ; other P > 0.05 ) ; urine neutrophil gelatinase-associated lipocalin , an early marker of IRI , was lower in the RIC group at hours 2 , 12 , 24 , and 48 ( 2 h , 48h , P > 0.05 ; 12h , 24h , P < 0.05 ) compared with that of the control group .


The graft pathology showed no differences between RIC and control groups .


RIC enhanced the early recovery of renal function in recipients after kidneytransplantation .


Our results provide a novel potential approach to attenuate transplantation-associated IRI .


To assess the effect of bilateral ultrasound-guided transversus abdominis plane block with ropivacaine compared with placebo as part of a multimodal analgesic regimen .


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


Hvidovre University Hospital .


Forty-six women scheduled for total abdominal hysterectomy .


Women received either ropivacaine 0.75 % , 20 mL ( n = 24 ) or 0.9 % saline , 20 mL ( n = 24 ) in the transversus abdominis plane on each side .


Primary outcome was the 24-h postoperative morphine consumption .


Secondary outcomes were pain scores at rest and during coughing , postoperative nausea and vomiting at 1 , 2 , 4 , 6 , 8 , and 24 h , and time to first mobilization .


There was no difference in the mean 24-h postoperative morphine consumption between the two groups ( p = 0.733 ) .


The ropivacaine group had significantly lower median pain scores at 1 h ( p = 0.008 ) and 2 h ( p = 0.027 ) postoperatively at rest and at 8 h ( p = 0.028 ) during coughing .


There was no significant difference in other secondary outcomes .


There was no reduction in 24-h morphine consumption when using an ultrasound-guided transversus abdominis plane block in women undergoing total abdominal hysterectomy .


As part of a multimodal regimen the transversus abdominis plane block showed some effect on pain scores at rest only in the early postoperative period .


To investigate the pharmacokinetics , safety , and analgesic efficacy of a novel topical formulation of lidocaine at insertion of an intrauterine device ( IUD ) .


Randomized controlled trial ; phase-I and phase-II studies .


University and public hospitals .


Women aged 18 years who wanted to receive an IUD .


Four women were parous in phase I ; all in phase II were nulliparous .


A single , 8.5-mL dose of lidocaine formulation ( SHACT ) was administered ( to the portio , cervix , and uterus ) with a specially designed applicator .


The phase-I study ( single-arm ) was designed for pharmacokinetic assessment ; the phase-II study ( randomized ) was intended for investigation of efficacy and safety .


From the phase-I study ( 15 participants ) , mean pharmacokinetic values were : maximum plasma concentration : 351 205 ng/mL ; time taken to reach maximum concentration : 68 41 minutes ; and area under the concentration-time curve from 0 to 180 minutes : 717 421 ng * h/mL .


Pain relief was observed with lidocaine vs. placebo in the phase-II study ( 218 women , randomized ) .


Mean visual analog scale score for maximum pain during the first 10 minutes after IUD insertion was 36 % lower with lidocaine than with placebo ( 28.3 24.6 vs. 44.2 26.0 ) .


Pain intensity was also significantly lower in the lidocaine group at 30 minutes .


On average , 3 of 4 patients will have less pain with lidocaine than with placebo .


Adverse events were similar in the placebo and lidocaine groups .


No serious adverse events were reported .


Lidocaine provides pain relief lasting for 30-60 minutes for women undergoing IUD insertion , without any safety concerns .


Further studies of this lidocaine formulation , for IUD insertion and other clinical applications , are planned .


2011-005660-18 and 2011-006220-20 ( EudraCT ) .


To compare laser in situ keratomileusis ( LASIK ) outcomes between 2 femtosecond lasers for flap creation in the treatment of myopia up to 1 year .


University eye clinic .


Prospective randomized eye-to-eye study .


Consecutive myopic patients were treated with wavefront-guided LASIK .


One eye had a flap created by the Intralase FS 60 kHz femtosecond laser , and the fellow eye was treated with the Intralase iFS 150 kHz femtosecond laser .


Eyes were randomized according to ocular dominance .


Evaluations included measurement of uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity , contrast sensitivity and wavefront aberrometry .


The study enrolled 122 eyes of 61 patients .


The mean preoperative spherical equivalent refraction was -4.62 diopters ( D ) 2.32 ( SD ) and -4.66 2.30 D in the 150 kHz group and 60kHz group , respectively .


Patients preferred the 150 kHz laser to the 60 kHz laser intraoperatively ( 52.5 % versus 26.2 % ) ( P = .005 ) .


One week postoperatively , UDVA was 20/16 or better in 85.2 % in the 150 kHz group and 70.5 % in the 60 kHz group ; the difference was statistically significant ( P < .05 ) .


At 12 months , there were no significant differences in refractive outcomes or higher-order aberrations between the 2 groups .


Flap creation with the 150 kHz system and the 60 kHz system resulted in excellent LASIK outcomes .


Intraoperatively , patients preferred the 150 kHz system , which yielded better UDVA in the early postoperative period .


There were no significant differences at 1 year between the 2 laser systems .


Proprietary or commercial disclosures are listed after the references .


To observe the clinical analgesic efficacy and the relation between clinical analgesic effect and duration of effect of two acupuncture methods of Longhu Jiaozhan ( fight of dragon and tiger , an acupuncture reinforcing and reducing manipulation characterized with nine counterclockwise and six clockwise rotations ) and even manipulations .


Sixty-two patients with primary dysmenorrhea were randomly divided into an observation group ( 32 cases ) and a control group ( 30 cases ) .


The observation group was applied with Longhu Jiaozhan manipulation , while the control group was applied with even manipulation .


Acupuncture treatment was given on both of the groups since onset of the pain .


The score of the visual analogue scale ( VAS ) of the 2 groups was observed at different times .


And 8 VAS values were recorded at the point right before acupuncture , needle remaining of 5 min , 10 min , 20 min and 30 min as well as and 30 min , 60 min , 120 min after needle withdrawal .


Comparison was made on differences between the 2 groups .


Comparison with the same group before acupuncture showed that the VAS difference of the time from needling remaining of 5 min to 120 min after acupuncture were all with statistic significance ( all P < 0.01 ) .


The score of VAS of needle remaining for 20 min and 30 min of the observation group was without significant difference ( P > 0.05 ) .


The score of VAS value of needle remaining for 20 min and 30 min of the control group was with significant difference ( P < 0.01 ) .


Comparison of the VAS scores before the treatment and the scores of the 2nd menstrual cycle were found with significant difference ( P < 0.01 ) .


The VAS score of 2nd menstrual cycle was ( 28.73 + / - 16.15 ) in the observation group , which was better than ( 46.93 + / -12.18 ) in the control group ( P < 0.001 ) .


Comparison of the VAS score of the two groups at 5 min r emaining of the needle was without statistic significance between two groups ( P > 0.05 ) .


However , the VAS impairment magnitude difference at that moment was with statistic significance ( P < 0.01 ) .


From the time of needle remaining for 10 min , 20 min , 30 min until 120 min after needling , the differences of the VAS scores and impairment range were all with statistic significance ( all P < 0.01 ) .


The effects of the two acupuncture techniques could both be maintained up to 2 hours after needling .


Both methods of acupuncture have immediate and long-term analgesic effect in a certain degree on primary dysmenorrhea .


However , compared with the control group , the advantage of analgesic effect in the observation group is significantly superior .


20 min needling remaining can reach the best analgesic effect .


Our randomized controlled trial ( The BETTER Trial ) found that training a clinician to become a Prevention Practitioner ( PP ) in family practices improved chronic disease prevention and screening ( CDPS ) .


PPs were trained on CDPS and provided prevention prescriptions tailored to participating patients .


For this embedded qualitative study , we explored perceptions of this new role to understand the PP intervention .


We used grounded theory methodology and purposefully sampled participants involved in any capacity with the BETTER Trial .


Two physicians and one coordinator in each of two cities ( Toronto , Ontario and Edmonton , Alberta ) conducted eight individual semi-structured interviews and seven focus groups .


We used an interview guide and documented research activities through an audit trail , journals , field notes and memos .


We analyzed the data using the constant comparative method throughout open coding followed by theoretical coding .


A framework and process involving external and internal practice facilitation using the new role of PP was thought to impact CDPS .


The PP facilitated CDPS through on-going relationships with patients and practice team members .


Key components included : 1 ) approaching CDPS in a comprehensive manner , 2 ) an individualized and personalized approach at multiple levels , 3 ) integrated continuity that included linking the patients and practices to CPDS resources , and 4 ) adaptability to different practices and settings .


The BETTER framework and key components are described as impacting CDPS through a process that involved a new role , the PP .


The introduction of a novel role of a clinician within the primary care practice with skills in CDPS could appropriately address gaps in prevention and screening .


To observe the therapeutic effect of body acupuncture combined with auricular acupressure for treatment of menstrual headache of hyperactivity of `` liver fire '' .


A total of 85 menstrual headache patients with hyperactivity of `` liver-fire '' were randomly divided into control group ( n = 42 ) and treatment group ( n = 43 ) .


Patients of the control group were treated by oral administration of Flunarizine Hydrochloride Capsules ( Sibelium , 5 mg/time , twice daily ) for 5 days beginning at the headache attack in the first menstrual cycle , and for two weeks ( except weekends ) in the second and third menstrual cycles .


Patients of the treatment group were treated by manual acupuncture stimulation of body acupoints Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Sanyinjiao ( SP 6 ) , Taichong ( LR 3 ) , Xiaxi ( GB 43 ) , Taiyang ( EX-HN 5 ) , Hanyan ( GB 4 ) , Xuanlu ( GB 5 ) and Shuaigu ( GB 8 ) beginning from the headache attack , and otopoint-pellet pressure of otopoints unilateral Endocrine , Ovaries , Shenmen , Cortex , Liver , Spleen and Kidney ( beginning 5 days before menstrual onset ) and bilateral Shenmen , Nie , Liver , Gallbladder , Subcortex and Jiaogan during headache attack .


Clinical symptom scores were assessed according to the `` Guiding Principles for Clinical Research on New Chinese Herbal Drugs '' issued by the Chinese Ministry of Health .


After the treatment , of the 42 and 43 cases in the control and treatment groups , 9 ( 21.43 % ) and 20 ( 46.51 % ) were cured , 12 ( 28.57 % ) and 14 ( 32.56 % ) had a marked improvement , 13 ( 30.95 % ) and 7 ( 16.28 % ) were effective , 8 ( 19.05 % ) and 2 ( 4.65 % ) invalid , with the effective rates being 80.95 % and 95.35 % , respectively .


The curative effect of the treatment group was significantly better than that of the control group ( P < 0.05 ) .


The symptom score and VAS score after the treatment and 3 months post-treatment in the treatment group were significantly lower than those of the control group ( P < 0.01 ) .


The headache scores and VAS scores were significantly reduced following the treatment and 3 months after the treatment in both control and treatment groups ( P < 0.01 ) .


After the treatment for 2-3 therapeutic courses , the headache attack duration during menstruation was markedly and gradually shortened in both groups ( P < 0.01 ) , and therapeutic effect of the treatment group was significantly better than that of the control group ( P < 0.01 ) .


Body acupuncture combined with auricular acupressure treatment can effectively relieve menstrual headache in menstrual women with hyperactivity of `` liver fire '' .


Interleukin-17A is considered to be central to the pathogenesis of psoriasis .


We evaluated secukinumab , a fully human anti-interleukin-17A monoclonal antibody , in patients with moderate-to-severe plaque psoriasis .


In two phase 3 , double-blind , 52-week trials , ERASURE ( Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis ) and FIXTURE ( Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis ) , we randomly assigned 738 patients ( in the ERASURE study ) and 1306 patients ( in the FIXTURE study ) to subcutaneous secukinumab at a dose of 300 mg or 150 mg ( administered once weekly for 5 weeks , then every 4 weeks ) , placebo , or ( in the FIXTURE study only ) etanercept at a dose of 50 mg ( administered twice weekly for 12 weeks , then once weekly ) .


The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75 % or more from baseline in the psoriasis area-and-severity index score ( PASI 75 ) and a score of 0 ( clear ) or 1 ( almost clear ) on a 5-point modified investigator 's global assessment ( coprimary end points ) .


The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 81.6 % with 300 mg of secukinumab , 71.6 % with 150 mg of secukinumab , and 4.5 % with placebo ; in the FIXTURE study , the rates were 77.1 % with 300 mg of secukinumab , 67.0 % with 150 mg of secukinumab , 44.0 % with etanercept , and 4.9 % with placebo ( P < 0.001 for each secukinumab dose vs. comparators ) .


The proportion of patients with a response of 0 or 1 on the modified investigator 's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 65.3 % with 300 mg of secukinumab , 51.2 % with 150 mg of secukinumab , and 2.4 % with placebo ; in the FIXTURE study , the rates were 62.5 % with 300 mg of secukinumab , 51.1 % with 150 mg of secukinumab , 27.2 % with etanercept , and 2.8 % with placebo ( P < 0.001 for each secukinumab dose vs. comparators ) .


The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept .


Secukinumab was effective for psoriasis in two randomized trials , validating interleukin-17A as a therapeutic target .


( Funded by Novartis Pharmaceuticals ; ERASURE and FIXTURE ClinicalTrials.gov numbers , NCT01365455 and NCT01358578 , respectively . )


To compare the short term efficacy and tolerability of methylphenidate and atomoxetine in children with Attention deficit hyperactivity disorder ( ADHD ) .


Open label randomized parallel group clinical trial .


Child Guidance Clinic of a tertiary care hospital of Northern India from October 2010 to June 2012 .


69 patients ( age 6-14 y ) with a diagnosis of ADHD receiving methylphenidate or atomoxetine .


Methylphenidate ( 0.2-1 mg/kg/d ) or atomoxetine ( 0.5-1 .2 mg/kg/d ) for eight weeks .


Treatment response ( > 25 % change in baseline Vanderbilt ADHD Diagnostic Parent Rating Scale ( VADPRS ) ; Vanderbilt ADHD Diagnostic Teacher Rating Scale ( VADTRS ) ; Clinical Global Impression Severity Scale ( CGI-S ) at eight weeks and adverse effects .


Treatment response was observed in 90.7 % patients from methylphenidate group and 86.2 % patients of atomoxetine group at an average dose of 0.45 mg/kg/d and 0.61 mg/kg/d , respectively .


The patients showed comparable improvement on VADPRS ( P = 0.500 ) , VADTRS ( P = 0.264 ) and CGI-S ( P = 0.997 ) .


Weight loss was significantly higher in methylphenidate group ( -0.570.78 kg ; P = 0.001 ) , and heart rate increase was observed at higher rate in atomoxetine group ( 7 9 bpm ; P = 0.021 ) .


Methylphenidate and atomoxetine are efficacious in Indian children with ADHD at lesser doses than previously used .


Their efficacy and tolerability are comparable .


TRIAL REGISTRATION NO. : CTRI/2011/08 / 001981 .


There is not known if a viraemia post-oral polio vaccine ( OPV ) is detectable by modern molecular techniques .


Such viraemia could affect the performance of the real time-polymerase chain reaction ( PCR ) for non polio enterovirus ( EV ) detection , technique of growing clinical use for the study of febrile infants .


To determine viraemia post-first dose of OPV in healthy infants , by molecular techniques .


50 infants less than three months without previous VPO were randomized in 5 groups : a control group with pre-vaccination blood sample ( BS ) , group 1 BS at day 2 , group 2 BS at day 4 , group 3 , BS at day 6 and group 4 , BS at day 8 post-vaccination .


Conventional and specific PCR for poliovirus and real time PCR for non polio EV were performed in BS and in OPV samples .


No genetic material of poliovirus was detected in any infant , while in 9 of them ( 18 % ) non polio EV was identified .


Real time PCR for EV did not amplify poliovirus from OPV samples .


Results suggest that no post VPO viraemia detectable by molecular methods exists .


Considering that real time PCR for EV does not allow to identify polio virus , no false positives of the test are expected as a result of a recent VPO vaccination .


We documented presence of non polio EV in blood of healthy asymptomatic infants .


An ageing population increases demand on health and social care .


New approaches are needed to shift care from hospital to community and general practice .


A predictive risk stratification tool ( Prism ) has been developed for general practice that estimates risk of an emergency hospital admission in the following year .


We present a protocol for the evaluation of Prism .


We will undertake a mixed methods progressive cluster-randomised trial .


Practices begin as controls , delivering usual care without Prism .


Practices will receive Prism and training randomly , and thereafter be able to use Prism with clinical and technical support .


We will compare costs , processes of care , satisfaction and patient outcomes at baseline , 6 and 18 months , using routine data and postal questionnaires .


We will assess technical performance by comparing predicted against actual emergency admissions .


Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers .


We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups .


We will take account of covariates and explanatory factors .


In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis .


We will also examine changes in quality of life of patients across the risk spectrum .


We will record and transcribe focus groups and interviews and analyse them thematically .


We have received full ethical and R and D approvals for the study and Information Governance Review Panel ( IGRP ) permission for the use of routine data .


We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals .


The proposed study will provide information on costs and effects of Prism ; how it is used in practice , barriers and facilitators to its implementation ; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions .


Controlled Clinical Trials ISRCTN no .


ISRCTN55538212 .


The purpose of this study was to describe the longitudinal trajectories and bidirectional relationships of the physical-social and emotional functioning ( EF ) dimensions of positive aging and to identify their baseline characteristics .


Women age 65 and older who enrolled in one or more Women 's Health Initiative clinical trials ( WHI CTs ) and who had positive aging indicators measured at baseline and years 1 , 3 , 6 , and 9 were included in these analyses ( N = 2281 ) .


Analytic strategies included latent class growth modeling to identify longitudinal trajectories and multinomial logistic regression to examine the effects of baseline predictors on these trajectories .


A five-trajectory model was chosen to best represent the data .


For Physical-Social Functioning ( PSF ) , trajectory groups included Low Maintainer ( 8.3 % ) , Mid-Low Improver ( 10.4 % ) , Medium Decliner ( 10.7 % ) , Mid-High Maintainer ( 31.2 % ) , and High Maintainer ( 39.4 % ) ; for EF , trajectories included Low Maintainer ( 3 % ) , Mid-Low Improver ( 9 % ) , Medium Decliner ( 7.7 % ) , Mid-High Maintainer ( 22.8 % ) , and High Maintainer ( 57.5 % ) .


Cross-classification of the groups of trajectories demonstrated that the impact of a high and stable EF on PSF might be greater than the reverse .


Low depression symptoms , low pain , and high social support were the most consistent predictors of high EF trajectories .


Aging women are heterogeneous in terms of positive aging indicators for up to 9 years of follow-up .


Interventions aimed at promoting sustainable EF might have diffused effects on other domains of healthy aging .


To observe the clinical efficacy of warming Shen , enhancing Yang , invigorating qi , and nourishing blood method ( WSEYIQNBM ) combined artificial cycle therapy in treatment of premature ovarian failure ( POF ) patients of Shen yang deficiency syndrome ( SYDS ) .


Totally 96 POF patients of SYDS were randomly assigned to the treatment group and the control group , 48 in each group .


Patients in the treatment group were treated with WSEYIQNBM combined artificial cycle therapy , while those in the control group were treated with Western medicine artificial cycle therapy .


One month constituted 1 course , a total of 3 courses .


The menstruation and main symptoms were observed before and after treatment .


Serum levels of follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and estradiol ( E2 ) were detected before and after treatment .


The total effective rate was 85.43 % in the treatment group , higher than that of the control group ( 79.17 % , P < 0.05 ) .


Besides , better effect in improving Chinese medical symptoms was obtained in the treatment group ( P < 0.05 ) .


POF patients ' serum hormone levels and clinical symptoms could be improved by WSEYIQNBM combined artificial cycle therapy .


Controlled laboratory study .


To determine the time course of dexamethasone sodium phosphate ( Dex-P ) during iontophoresis to underlying tissues using microdialysis .


In human participants , real-time information of Dex-P transdermal delivery during iontophoresis is unknown .


Sixty-four healthy male participants ( mean SD age , 24.2 3.3 years ; height , 181.8 26.1 cm ; mass , 82.4 11.8 kg ; subcutaneous fat thickness , 0.61 0.19 cm ) were randomly assigned into 1 of 6 groups : ( 1 ) 1-mA current , 1-mm probe depth ; ( 2 ) 1-mA current , 4-mm probe depth ; ( 3 ) 2-mA current , 1-mm probe depth ; ( 4 ) 2-mA current , 4-mm probe depth ; ( 5 ) in vivo retrodialysis ; and ( 6 ) skin perfusion flowmetry .


Microdialysis probes were used to assess the combined recovery ( Dex-total ) of Dex-P , dexamethasone , and its metabolite .


There was no difference in Dex-total between current intensities ( P = .99 ) , but a greater amount of Dex-total was recovered superficially at 1 mm compared to the 4-mm depth ( P < .0001 ) .


Peak concentration mean SD values for the 1 - and 2-mA currents at 1 mm were 10.8 8.1 and 7.7 5.5 g/mL , and at 4 mm were 2.0 0.8 and 1.3 0.9 g/mL , respectively .


Peak skin perfusion was 741.4 % 408.7 % and 711.6 % 260.8 % at baseline for 1 - and 2-mA intensities , respectively .


Skin perfusion returned to baseline levels earlier during 1-mA intensity at a 110 mA min dose within the treatment , compared to 2 mA at 60 minutes posttreatment .


Transdermal delivery of Dex-P during iontophoresis was successfully measured in vivo through human skin .


Measurable concentrations of Dex-total were found regardless of current intensity .


Although current-induced vasodilation occurred , it did not significantly affect the tissue accumulation of Dex-total .


Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress .


This randomised controlled trial will investigate the effects of a transdiagnostic , Internet-administered cognitive behavioural ( iCBT ) self-help program for anxiety , supplemented with a smartphone application .


The effect of added therapist support will also be studied .


One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups : 1 , smartphone-supplemented iCBT with therapist support ; 2 , smartphone-supplemented iCBT without therapist support ; or 3 , an active waiting list control group with delayed treatment .


Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale .


Secondary measures include other anxiety , depression and quality of life measures .


In addition to pre - and post-treatment measurements , the study includes two mid-treatment ( days 24 and 48 ) and two follow-up assessments ( 12 and 36 months ) to assess rapid and long-term effects .


To our knowledge , this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders .


Hence , the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions .


Limitations are discussed .


Clinicaltrials.gov : NCT01963806 .


Work with families and families at risk within the field of music therapy have been developing for the last decade .


To diminish risk for unhealthy child development , families with emotionally neglected children need help to improve their emotional communication and develop healthy parent-child interactions .


While some researchers have investigated the effect of music therapy on either the parent or the child , no study has investigated the effect of music therapy on the observed interaction between the parent and child within the field of child protection .


The purpose of this study was to investigate the effect of a dyadic music therapy intervention on observed parent-child interaction ( mutual attunement , nonverbal communication , emotional parental response ) , self-reported parenting stress , and self-reported parent-child relationship in families at risk and families with emotionally neglected children , ages 5-12 years .


This was a randomized controlled trial study conducted at a family care center in Denmark .


Eighteen parent-child dyads were randomly assigned to receive 10 weekly music therapy sessions with a credentialed music therapist ( n = 9 ) or treatment as usual ( n = 9 ) .


Observational measures for parent-child interaction , self-reported measures for parenting stress and parent-child relationship were completed at baseline and 4 months post-baseline assessment .


Results of the study showed that dyads who received music therapy intervention significantly improved their nonverbal communication and mutual attunement .


Similarly , parents who participated in dyadic music therapy reported themselves to be significantly less stressed by the mood of the child and to significantly improve their parent-child relationship in terms of being better at talking to and understanding their children than parents who did not receive music therapy .


Both groups significantly improved in terms of increased positive and decreased negative emotional parental response , parenting stress and stress in general .


There were no significant between group differences in self-perceived autonomy , attachment , and parental competence .


The dyadic music therapy intervention examined in this study improved emotional communication between parent and child and interaction after 6 to 10 sessions and can be considered as a viable treatment alternative or supplement for families at risk and families with emotionally neglected children .


Symptoms and symptom burden have a central place in diagnosis and management of atrial fibrillation ( AF ) .


The aim of the present study is to investigate whether severity of AF symptoms impacts prognosis in permanent AF .


We studied the relation between AF symptom severity [ quantified with the Toronto AF Severity Scale ( AFSS ) ] and cardiovascular outcome in patients included in the RACE II study .


The primary endpoint was a composite of cardiovascular morbidity and mortality .


Secondary outcome was cardiovascular hospitalizations .


Of 614 permanent AF patients in RACE II , AFSS questionnaires were available in 558 patients ( 91 % ) .


Mean age was 68 8 years .


One hundred and seventy-four patients ( 31 % ) reported a low score ( score 0-3 ; lowest tertile ) , 190 patients ( 34 % ) reported a moderate score ( score 4-9 ; middle tertile ) , and 194 ( 35 % ) reported a high score ( score 10-35 ; highest tertile ) .


Patients with the most severe symptoms were more often women , had higher N-terminal prohormone of brain natriuretic peptide concentrations , and had more previous heart failure hospitalizations .


Median follow-up was 3.0 ( interquartile range 2.3-3 .0 ) years .


The primary endpoint occurred most frequently in the highest tertile of the AFSS [ 16 ( 9 % ) , 19 ( 10 % ) , 36 ( 19 % ) , respectively , P = 0.01 ] , being mainly driven by heart failure hospitalizations [ 4 ( 2 % ) , 1 ( 1 % ) , 16 ( 8 % ) , respectively , P < 0.001 ] .


After multivariable adjustment , higher AFSS scores were associated with the primary endpoint [ hazard ratio 1.38 ( 1.15-1 .66 ) , P = 0.001 ] , as well as with cardiovascular hospitalizations [ hazard ratio 1.33 ( 1.14-1 .54 ) , P < 0.001 ] .


In permanent AF , after multivariable adjustment , symptom severity is associated with cardiovascular outcome .


Combinations of inhaled long-acting bronchodilator therapies such as muscarinic antagonists and 2-agonists may be more effective than monotherapy in the treatment of chronic obstructive pulmonary disease ( COPD ) .


This study was a 24-week , Phase III , multicenter , randomized , blinded , double-dummy , parallel-group study of the once-daily , inhaled , fixed-dose combination of the long-acting muscarinic antagonist umeclidinium bromide and the long-acting 2-agonist vilanterol ( UMEC/VI 62.5 / 25 mcg ) versus tiotropium ( TIO , 18 mcg ) .


The primary endpoint was trough forced expiratory volume in 1 s ( FEV1 ) at Day 169 .


The secondary endpoint was weighted mean FEV1 over 06 h post-dose at Day 168 .


For key endpoints , a step-down closed testing hierarchy was applied to account for multiplicity .


Other efficacy and safety endpoints were assessed .


Statistically significant improvements in trough FEV1 at Day 169 ( 0.112 L , 95 % confidence interval [ CI ] : 0.081 , 0.144 ; p < 0.001 ) and weighted mean FEV1 over 06 h post-dose at Day 168 ( 0.105 L , 95 % CI : 0.071 , 0.140 ; p < 0.001 ) were observed for UMEC/VI versus TIO .


In addition UMEC/VI improved health-related quality of life , and reduced requirement for the use of rescue medication compared with TIO .


The incidence of adverse events was similar between treatment groups .


UMEC/VI was associated with statistically significant and clinically meaningful improvements in lung function versus TIO .


UMEC/VI was well tolerated .


UMEC/VI 62.5 / 25 mcg could provide an effective new treatment option for patients with moderate-to-very severe COPD .


Previous human studies reported inconsistent effects of dietary protein and branched-chain amino acids ( BCAAs ) on insulin action and glucose metabolism .


Similarly , it is unclear whether saturated fat ( SF ) intake influences these metabolic variables .


The objective of this study was to test the effects of high [ 30 % of energy ( % E ) ] vs. moderate ( 20 % E ) intakes of protein ( primarily whey ) on insulin action and lipid and lipoprotein concentrations in the context of both high ( 15 % E ) and low ( 7 % E ) SF diets .


The study was conducted as a randomized controlled trial in 158 overweight and obese men and women .


After a 4-wk baseline diet [ 55 % E carbohydrate , 15 % E protein , 30 % E fat ( 7 % E SF ) ] , participants were randomly assigned to 4 wk of either the baseline diet or 1 of 4 test diets containing 35 % E carbohydrate and either 20 % E or 30 % E protein and either 7 % E or 15 % E SF .


Frequently sampled i.v. glucose tolerance tests were administered after each dietary period .


Other than significantly higher fasting glucose concentrations for high vs. moderate protein intakes with a low-fat diet ( difference SE : 0.47 0.14 mmol/L ; P = 0.001 ) , there were no significant effects of dietary protein or SF on glucose metabolism , plasma insulin , or concentrations of lipids and lipoproteins .


Changes in plasma BCAAs across all diets were negatively correlated with changes in the metabolic clearance rate of insulin ( = -0.18 , P = 0.03 ) and positively correlated with changes in the acute insulin response to glucose ( = 0.15 , P = 0.05 ) .


These findings suggest that short-term intake of BCAAs can influence insulin dynamics .


However , in this group of overweight and obese individuals , neither high protein nor SF intake affected insulin sensitivity or plasma concentrations of lipids and lipoproteins .


This trial was registered at clinicaltrials.gov as NCT00508937 .


Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease ( COPD ) .


To compare the efficacy and safety of once-daily umeclidinium/vilanterol ( UMEC/VI ) 125/25 mcg with placebo and UMEC or VI monotherapy in COPD .


This was a double-blind , placebo-controlled , parallel-group study .