Treatment with rFVIIa was associated with a reduction in operation time , red blood cell and fresh froze plasma transfusion , blood loss and prothrombin time compared to the control group ( p < @ for all ) .


Activated partial thromboplastin time and mortality were similar between the two groups ( P > @ ) .


Treatment with rFVIIa significantly improved the extrinsic coagulation function in patients with severe acute pancreatitis and was associated with decreased risk of bleeding .


However , rFVIIa did not improve intrinsic coagulation or reduce over-cause mortality .


The aim is to determine , from the patient 's perspective , what constitutes a good hand-off procedure in the emergency department ( ED ) .


The secondary purpose is to evaluate what impact a formalized hand-off had on patient knowledge , throughput and customer service


This study used a randomized controlled clinical trial involving two unique hand-off approaches and a convenience sample .


The study alternated between the current hand-off process that documented the process but not specific elements ( referred to as the informal process ) to one using the IPASS the BATON process ( considered the formal process ) .


Consenting patients completed a @-question validated questionnaire on how the process was perceived by patients and about their understanding why they waited in the ED .


Statistical analysis using SPSS calculated descriptive frequencies and t-tests .


In total @ patients were enrolled : @ in the informal and @ in the formal group .


Most patients had positive answers to the customer survey .


There were significant differences between formal and informal groups : recalling the oncoming and outgoing physician coming to the patient 's bed ( p = @ ) , with more formal group recalling that than informal group patients ; the oncoming physician introducing him/herself ( p = @ ) , with more from the formal group answering yes and the physician discussing tests and implications with formal group patients ( p = @ ) .


This study was done at an urban inner city ED , a fact that may have skewed its results .


A comparison of suburban and rural EDs would make the results stronger .


It also reflected a very high level of customer satisfaction within the ED .


This lack of variance may have meant that the correlation between customer service and handoffs was missed or underrepresented .


There was no codified observation of either those using the IPASS the BATON script or those using informal procedures , so no comparison of level and types of information given between the two groups was done .


There could have been a bias of those attending who had internalized the IPASS the BATON procedures and used them even when they were assigned to the informal group .


A hand off from one physician to the next in the emergency department is best done using a formalized process .


IPASS the BATON is a useful tool for hand off in the ED in part because it involved the patient in the process .


The formal hand off increased communication between patient and doctor as its use increased the patient 's opportunity to ask and respond to questions .


The researchers evaluated an ED physician specific hand-off process and illustrate the value and impact of involving patients in the hand-off process .


To compare the efficacy of a shorter interval ( @hours ) between misoprostol and mifepristone administration with that of the conventional dosing interval ( @hours ) for second-trimester termination of pregnancy ( TOP ) .


This was a prospective randomized , controlled , open-label study of @ healthy women opting for mid-trimester TOP .


The women were randomized to receive @mg mifepristone orally , followed @hours ( Group @ ) or @hours ( Group @ ) later by misoprostol ( @g , then @g every @hours ) .


The primary outcome measure was the percentage of successful abortions within @hours .


Secondary outcome measures were the induction-to-abortion interval ( measured from misoprostol administration ) and the frequencies of complications and adverse effects .


The rate of successful abortions was similar with the @-hour and @-hour dosing intervals ( @ % and @ % , respectively ; P = @ ) .


The mean induction-to-abortion interval was also comparable between the @ groups ( @ hours versus @ hours ; P = @ ) .


Nulliparous women and women with a pregnancy duration of @weeks or more had a longer induction-to-abortion interval in both groups .


The @-hour dosing interval between misoprostol and mifepristone administration seems to be as effective as the @-hour dosing interval for second trimester TOP .


Clinical Trial Registry India : CTRI/@/@ / @ .


The effects of combined aerobic and resistance exercise training on central arterial stiffness and gait velocity in patients with chronic poststroke hemiparesis were investigated .


Twenty-six patients with chronic poststroke hemiparesis were randomly assigned to either the combined aerobic and resistance exercise group ( n = @ ) or the control group ( n = @ ) .


The exercise intervention group received a combined aerobic and resistance exercise training ( @ hr/day , three times/week for @ wks ) , whereas the control group received usual care .


Central arterial stiffness was determined by pulse wave velocity and augmentation index .


Gait velocity was assessed using the @-min walk test , @-m walk test , and the Timed Up-and-Go test .


Patients in the exercise intervention group had greater improvement of mean pulse wave velocity ( P < @ ) , augmentation index ( P = @ ) , and gait velocity ( @-min walk test , P < @ ; @-m walk test , P < @ ) than did patients in the control group .


Patients in the exercise intervention group also had greater improvements in physical fitness component ( grip strength , P < @ ; muscular strength of upper and lower limbs , P < @ ; flexibility , P < @ ) when compared with control patients .


The combined aerobic and resistance exercise program significantly reduced central arterial stiffness and increased gait velocity in patients with chronic poststroke hemiparesis .


To evaluate whether levels of corneal subbasal nerve fiber length ( SNFL ) in dry eye disease ( DED ) could prognosticate the level of improvement in signs and symptoms after treatment .


Phase IV , double-masked , randomized clinical trial .


Sixty patients with meibomian gland dysfunction-associated DED and @ age-matched controls .


Patients with DED were randomized to receive topical artificial tears , loteprednol etabonate @ % , or loteprednol etabonate @ % / tobramycin @ % twice daily for @ weeks .


At baseline , in vivo confocal microscopy of central cornea was performed in both eyes .


Patients with DED were divided into @ subgroups : those with low baseline SNFL and those with near-normal baseline SNFL for this purpose ( the cutoff point : the mean SNFL in controls minus @ standard deviations ) .


Clinical signs and symptoms at baseline and after @ weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups .


Symptom questionnaires , corneal fluorescein staining ( CFS ) , conjunctival staining with lissamine green , tear break-up time , Schirmer 's test , and SNFL .


In patients with DED , baseline SNFL ( @ mm/mm ( @ ) ) was significantly lower than in controls ( @ mm/mm ( @ ) , P = @ ) .


In the artificial tear and loteprednol groups , although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL ( < @ mm/mm ( @ ) ) , subjects with near-normal baseline SNFL ( @ mm/mm ( @ ) ) showed significant improvement in both symptoms and CFS score ( all P < @ ) .


In the loteprednol/tobramycin group , no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL .


Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL .


Consideration of SNFL may assist in explaining the variability of patients ' response to DED therapy .


To evaluate the effect mechanism of warm acupuncture combined with auricular point sticking therapy and its efficacy on insomnia by monitoring the level of brain neurotransmitters in the insomnia patients .


One hundred and thirty patients with insomnia were randomized into an observation group and a control group , @ cases in each one .


In the observation group , based on the treating principle of warming yang and benefiting qi , acupuncture was applied to Xinshu ( BL @ ) , Pishu ( BL @ ) , Shenshu ( BL @ ) , Yaoyangguan ( GV @ ) , Baihui ( GV @ ) , Neiguan ( PC @ ) and Shenmen ( HT @ ) .


Warm acupuncture was supplemented at Xinshu ( BL @ ) , Pishu ( BL @ ) , Shenshu ( BL @ ) and Yaoyangguan ( GV @ ) .


The treatment was given once every day .


In the control group , estazolam tablets , @ to @ mg were prescribed for oral administration , @ min before sleep at night .


The treatment of @ days was taken as one session and @ sessions were required in the two groups .


The encephal of luctuograph technology was used to observe the sleep quality and brain neurotransmitters before and after treatment in the two groups and the efficacy was compared between the two groups .


The total effective rate was @ % ( @/@ ) in the observation group and @ % ( @/@ ) in the control group .


The efficacy was similar between the two groups ( P > @ ) .


In the observation group , after treatment , @-HT and GABA/Glu were all increased compared with those before treatment ( P < @ , P < @ ) and norepinephrine ( NE ) was reduced compared with that before treatment ( P < @ ) .


The level of each index did not change significantly before and after treatment in the control group ( all P > @ ) .


The regulations of @-HT , GABA/Glu in the observation group were superior to those in the control group ( all P < @ ) .


The combined therapy of warm acupuncture and auricular point sticking method for warming yang and benefiting qi effectively improves brain neurotransmitters and essentially improves sleep quality of the patients with insomnia differentiated as yang deficiency pattern .


To compare long-term outcomes and retreatment rates for patients with Dupuytren disease who underwent needle aponeurotomy ( NA ) combined with a series of triamcinolone acetonide injections or underwent NA alone as part of a prior randomized controlled trial .


During this follow-up study , @ of @ participants in the original study were examined as needed between @ and @ months from their initial procedure .


Those who had not been reassessed within @ months of the original NA were asked to return for follow-up .


The average total active extension deficit ( TAED ) of previously treated joints was compared between groups @ to @ , @ to @ , @ to @ , and @ to @ months following treatment .


Timing of retreatment ( if performed ) was recorded .


Forty-four participants returned for assessment an average of @ times over @months .


Mean TAED was significantly less in needle aponeurotomy triamcinolone injection patients at @ months and between @ and @ months .


Sixty-two percent of NA group patients and @ % of needle aponeurotomy triamcinolone injection patients returned for a second treatment on the same digit ( s ) ( retreatment ) .


This difference was not significant .


Mean time to retreatment and mean TAED immediately prior to retreatment did not differ significantly between groups .


Kaplan-Meier survival estimates demonstrated a significantly higher percentage of NA group patients expected to return for retreatment by @ but not by @ months .


Younger age , more than one joint treated at the initial NA , and TAED severity throughout the follow-up period were associated with earlier retreatment .


Serial triamcinolone injections combined with NA was associated with lower TAED for up to @ months .


A larger study would more accurately quantify the potential benefits of combining triamcinolone injections with NA for treatment of Dupuytren disease .


Therapeutic III .


Increasing levels of physical activity in mothers have long-term health benefits for the mother and family .


The study aimed to evaluate the effect of a six-month , physical activity RCT for mothers of young children .


Women were recruited via playgroups and randomly assigned to intervention ( n = @ ) or control group ( n = @ ) .


The intervention group received a six-month multi-strategy programme delivered via playgroups in Perth , Australia .


measures were mean minutes per week of moderate ( M ) and vigorous ( V ) intensity physical activity ( PA ) , and number of days/week of muscle strength exercises .


The intervention had a significant effect on mean time for vigorous ( p = @ ) , moderate ( p = @ ) and total physical activity ( p = @ ) when compared to the control group .


The intervention group increased their vigorous activity by a mean of @min/week , moderate activity by @min/week and total physical activity by @min/week .


A relatively minimum home based intervention was able to demonstrate modest but statistically significant improvements in physical activity in a hard to reach group .


These changes if maintained over a longer period are likely to improve the health of mothers and have a positive impact on their partners and children .


Australian and New Zealand Clinical Trials Registry ACTRN@ .


To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) scores during @-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer ( mCRPC ) after chemotherapy in the AFFIRM trial .


Patients were randomly assigned to enzalutamide @ mg/day or placebo .


FACT-P was completed before randomization , at weeks @ , @ , @ , and @ , and every @ weeks thereafter while on study treatment .


Longitudinal changes in FACT-P scores from baseline to @ weeks were analyzed using a mixed effects model for repeated measures ( MMRM ) , with a pattern mixture model ( PMM ) applied as secondary analysis to address non-ignorable missing data .


Cumulative distribution function ( CDF ) plots were generated and different methodological approaches and models for handling missing data were applied .


Due to the exploratory nature of the analyses , adjustments for multiple comparisons were not made .


AFFIRM is registered with ClinicalTrials.gov , number NCT@ .


The intention-to-treat FACT-P population included @ patients ( enzalutamide , n = @ ; placebo n = @ ) with evaluable FACT-P assessments at baseline and @ post-baseline assessment .


After @ weeks , the mean FACT-P total score decreased by @ points with enzalutamide compared with @ points with placebo ( P < @ ) .


In addition , significant treatment differences at week @ favoring enzalutamide were evident for all FACT-P subscales and indices , whether analyzed by MMRM or PMM .


CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease - and symptom-specific subscales/indices .


In men with progressive mCRPC after docetaxel-based chemotherapy , enzalutamide is superior to placebo in health-related quality-of-life outcomes , regardless of analysis model or threshold selected for meaningful response .


Arterial access is a major site of bleeding complications after invasive coronary procedures .


Among strategies to decrease vascular complications , the radial approach is an established one .


Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest .


However , the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications , requiring evidence through adequately designed randomized trials .


The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy .


ARISE is a national , multicenter , non-inferiority randomized clinical trial .


Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device .


The primary outcome is the occurrence of vascular complications at an arterial puncture site @days after the procedure , including major bleeding , retroperitoneal hematoma , compartment syndrome , hematoma@cm , pseudoaneurysm , arterio-venous fistula , infection , limb ischemia , arterial occlusion , adjacent nerve injury or the need for vascular surgical repair .


Enrollment was initiated in September @ , and until October @ @ patients were included .


The inclusion phase is expected to last until the second half of @ .


The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS .


Preclinical studies indicate that oxytocin is anorexigenic and has beneficial metabolic effects .


Oxytocin effects on nutrition and metabolism in humans are not well defined .


It was hypothesized that oxytocin would reduce caloric intake and appetite and alter levels of appetite-regulating hormones .


Metabolic effects of oxytocin were also explored .


A randomized , placebo-controlled crossover study of single-dose intranasal oxytocin ( @ IU ) in @ fasting healthy men was performed .


After oxytocin/placebo , subjects selected breakfast from a menu and were given double portions .


Caloric content of food consumed was measured .


Visual analog scales were used to assess appetite , and blood was drawn for appetite-regulating hormones , insulin , and glucose before and after oxytocin/placebo .


Indirect calorimetry assessed resting energy expenditure ( REE ) and substrate utilization .


Oxytocin reduced caloric intake with a preferential effect on fat intake and increased levels of the anorexigenic hormone cholecystokinin without affecting appetite or other appetite-regulating hormones .


There was no effect of oxytocin on REE .


Oxytocin resulted in a shift from carbohydrate to fat utilization and improved insulin sensitivity .


Intranasal oxytocin reduces caloric intake and has beneficial metabolic effects in men without concerning side effects .


The efficacy and safety of sustained oxytocin administration in the treatment of obesity warrants investigation .


Benzodiazepines ( BZDs ) are the first-line drugs in alcohol-withdrawal syndrome ( AWS ) .


Baclofen , a gamma-aminobutyric acidB ( GABAB ) agonist , controls withdrawal symptoms without causing significant adverse effects .


The objective of this study was to compare the cost-effectiveness of baclofen and chlordiazepoxide in the management of uncomplicated AWS .


This was a randomized , open label , standard controlled , parallel group study of cost-effectiveness analysis ( CEA ) of baclofen and chlordiazepoxide in @ participants with uncomplicated AWS .


Clinical efficacy was measured by the Clinical Institute Withdrawal Assessment for alcohol ( CIWA-Ar ) scores .


Lorazepam was used as supplement medication if withdrawal symptoms could not be controlled effectively by the study drugs alone .


Both direct and indirect medical costs were considered and the CEA was analyzed in both patient 's perspective and third-party perspective .


The average cost-effectiveness ratio ( ACER ) in patient 's perspective of baclofen and chlordiazepoxide was Rs .


@,@ and Rs .


@,@ per symptom-free day , respectively .


The ACER in third-party perspective of baclofen and chlordiazepoxide was Rs .


@ and Rs .


@ per symptom-free day , respectively .


Participants on chlordiazepoxide had more number of symptom-free days when compared with the baclofen group on analysis by Mann-Whitney test ( U = @ , P = @ ) .


Both study drugs provided relief of withdrawal symptoms .


Chlordiazepoxide was more cost-effective than baclofen .


Baclofen was relatively less effective and more expensive than chlordiazepoxide .


This study was aimed to assess the outcome of Ilioinguinal , Iliohypogastric block and wound infiltration with @ % ropivacaine on pain perception , first analgesic request and hospital stay following inguinal Lichtenstein mesh repair .


This was a prospective , randomized , double-blind study with @ patients undergoing inguinal hernioplasty under general anesthesia .


Patients were randomly allocated to one of the two groups by the sealed envelope method .


Group @ ( n = @ ) received nerve blocks and incision infiltration with @ % ropivacaine while group @ ( n = @ ) received isotonic saline .


Postoperatively pain intensity , time of demand for the first analgesic and duration of hospital stay were assessed .


Median Visual Analog Scale ( VAS ) score of group @ was @ ( high = @ , low = @ ) while for group @ was @ ( high = @ , low = @ ) and the p value was < @ .


Mean time for the demand of the first analgesic was prolonged from @ h to @ h with the p value of < @ , while the mean time of hospital stay was reduced from @ h to @ h with the p value of < @ .


Preemptive analgesia with @ % ropivacaine causes significant reduction in pain perception , request for an analgesic and hospital stay .


Therefore it is advisable before inguinal hernioplasty .


The use of intensity-modulated radiotherapy ( IMRT ) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis , telangectasia and sub-optimal cosmesis .


Patient reported outcome measures ( PROMs ) are also important as they provide the patient 's perspective .


This longitudinal study reports on ( a ) the effect of forward planned field-in-field IMRT ( simple IMRT ) on PROMs compared to standard RT at @ years after RT , ( b ) factors affecting PROMs at @years after RT and ( c ) the trend of PROMs over @ years of follow up .


PROMs were assessed at baseline ( pre-RT ) , @ , @ and @ months after completion of RT using global health ( EORTC QLQ C@ ) and @ breast symptom questions ( BR@ ) .


Also , @ breast RT-specific questions were included at @ , @ and @ months : change in skin appearance , firmness to touch , reduction in breast size and overall change in breast appearance since RT. .


The benefits of simple IMRT over standard RT at @ years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions .


Clinical factors affecting PROMs at @ years were investigated using a multivariate analysis .


A repeated mixed model was applied to explore the trend over time for each of PROMs .


( @ % ) @/@ , @ % , @ % and @ % patients completed questionnaires at baseline , @ , @ and @ months respectively .


Patients reported worse toxicity for all four BR@ breast symptoms at @ months , which then improved over time ( p < @ ) .


They also reported improvement in skin appearance and breast hardness over time ( p < @ ) , with no significant change for breast shrinkage ( p = @ ) and overall breast appearance ( p = @ ) .


At @years , PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy .


Large breast volume , young age , baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs .


This study was unable to demonstrate the benefits of IMRT on PROMs at @years .


PROMs are influenced by non-radiotherapy factors and surgical factors should be optimised to improve patients ' outcome .


Only a small proportion of patients report moderate-severe breast changes post radiotherapy , with most PROMs improving over time .


The difference in clinician assessment and PROMs outcome requires further investigation .


Sacral nerve stimulation ( SNS ) is a well established therapy for faecal incontinence ( FI ) .


Percutaneous tibial nerve stimulation ( PTNS ) is a newer , less invasive , treatment .


The effectiveness and acceptability of these treatments have not been compared systematically .


An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed .


Quantitative clinical outcomes and qualitative data from patient interviews were collected for both interventions .


Forty patients ( @ women ; mean age @ years ) met the eligibility criteria ; @ were randomized to receive SNS and @ to PTNS .


Fifteen patients progressed to permanent SNS implantation and @ received a full course of PTNS .


Within-group effect sizes were marginally greater for SNS than for PTNS on available-case analysis .


Mean ( s.d. ) FI episodes per week at baseline , and @ and @ months of follow-up were : @ ( @ ) , @ ( @ ) and @ ( @ ) respectively for SNS compared with @ ( @ ) , @ ( @ ) and @ ( @ ) for PTNS .


Mean ( s.d. ) Cleveland Clinic Incontinence Score values at baseline , and @ and @ months were : @ ( @ ) , @ ( @ ) and @ ( @ ) for SNS versus @ ( @ ) , @ ( @ ) and @ ( @ ) for PTNS .


Improvement of at least @ per cent in FI episodes per week at @ months was seen in @ of @ patients in the SNS group compared with seven of @ in the PTNS group .


Effect estimates for SNS with chronic implanted stimulation were larger ( @ of @ patients at @ months ) .


Disease-specific and generic quality-of-life improvements complemented clinical outcome data .


Qualitative analysis of interview data suggested that both treatments had high acceptability amongst patients .


In the short term , both SNS and PTNS provide some clinical benefit to patients with FI .


Registration numbers : @-@-@ and @ ( http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=@ ) .


To assess efficacy and safety of fulranumab , a fully human monoclonal antibody against nerve growth factor , in patients with diabetic peripheral neuropathic pain ( DPNP ) .


In this phase II , double-blind , placebo-controlled trial , patients with moderate to severe DPNP were randomized to treatments with fulranumab ( @ , @ , or @ mg ) or placebo administered subcutaneously every @ weeks .


Because of early study termination ( clinical hold ) by the US Food and Drug Administration , @ ( intent-to-treat ) of the planned @ patients were enrolled .


The primary endpoint , the mean reduction of average daily pain at week @ compared with baseline , showed a positive dose-response relationship ( p = @ , @-sided ) ; the pair-wise comparison between the @-mg group and placebo was significant ( unadjusted p = @ , @-sided ) .


An exploratory responder analysis revealed that a greater proportion of patients in the @-mg group reported @ % reduction in the average DPNP intensity compared with placebo at week @ ( p = @ ) .


Although not statistically significant , several secondary endpoints showed directionally similar results to the primary efficacy dose-response relationship .


During the combined efficacy and safety extension phases , the top @ treatment-emergent adverse events in the combined fulranumab group were arthralgia ( @ % ) , edema peripheral ( @ % ) , and diarrhea ( @ % ) .


No cases of joint replacement or death were reported .


Despite early study termination , fulranumab treatment resulted in dose-dependent efficacy and was generally well tolerated .


This study provides Class I evidence that in patients with DPNP , fulranumab @ mg reduces pain by @ points on an @-point scale compared with placebo .


Angiogenesis is a valid target in the treatment of epithelial ovarian cancer .


Trebananib inhibits the binding of angiopoietins @ and @ to the Tie@ receptor , and thereby inhibits angiogenesis .


We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival .


For this randomised , double-blind phase @ study undertaken between Nov @ , @ , and Nov @ , @ , we enrolled women with recurrent epithelial ovarian cancer from @ countries .


Patient eligibility criteria included having been treated with three or fewer previous regimens , and a platinum-free interval of less than @ months .


We enrolled patients with a computerised interactive voice response system , and patients were randomly assigned using a permuted block method ( block size of four ) in a @:@ ratio to receive weekly intravenous paclitaxel ( @ mg/m ( @ ) ) plus either weekly masked intravenous placebo or trebananib ( @ mg/kg ) .


Patients were stratified on the basis of platinum-free interval ( @ and @ months vs > @ and @ months ) , presence or absence of measurable disease , and region ( North America , western Europe and Australia , or rest of world ) .


The sponsor , investigators , site staff , and patients were masked to the treatment assignment .


The primary endpoint was progression-free survival assessed in the intention-to-treat population .


The trial is registered with ClinicalTrials.gov , NCT@ , and is no longer accruing patients .


@ patients were enrolled , of whom @ were randomly assigned to the trebananib group and @ to the placebo group .


Median progression-free survival was significantly longer in the trebananib group than in the placebo group ( @ months -LSB- @-@ -RSB- vs @ months -LSB- @ % CI @-@ -RSB- , respectively , hazard ratio @ , @ % CI @-@ , p < @ ) .


Incidence of grade @ or higher adverse events was similar between treatment groups ( @ -LSB- @ % -RSB- of @ patients in the placebo group vs @ -LSB- @ % -RSB- of @ patients in the trebananib group ) .


Trebananib was associated with more adverse event-related treatment discontinuations than was placebo ( @ -LSB- @ % -RSB- patients vs @ -LSB- @ % -RSB- , respectively ) and higher incidences of oedema ( @ -LSB- @ % -RSB- patients had any-grade oedema in the trebananib group vs @ -LSB- @ % -RSB- patients in the placebo group ) .


Grade @ or higher adverse events included ascites ( @ -LSB- @ % -RSB- in the placebo group vs @ -LSB- @ % -RSB- in the trebananib group ) , neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and abdominal pain ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


We recorded serious adverse events in @ ( @ % ) patients in the placebo group and @ ( @ % ) patients in the trebananib group .


There was a difference of @ % or less in class-specific adverse events associated with anti-VEGF therapy ( hypertension , proteinuria , wound-healing complications , thrombotic events , gastrointestinal perforations ) , except bleeding , which was more common in the placebo group than in the trebananib group ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Inhibition of angiopoietins @ and @ with trebananib provided a clinically meaningful prolongation in progression-free survival .


This non-VEGF anti-angiogenesis option for women with recurrent epithelial ovarian cancer should be investigated in other settings and in combination with additional agents .


Although oedema was increased , typical anti-VEGF associated adverse events were not prominent .


A close correlation exists between positron emission tomography ( PET ) - determined histamine H@ - receptor occupancy ( H@ RO ) and the incidence of sedation .


Antihistamines with H@ RO < @ % are classified as non-sedating .


The objective was to compare the H@ RO of bilastine , a second generation antihistamine , with that of hydroxyzine .


This randomized , double-blind , crossover study used PET imaging with -LSB- ( @ ) C -RSB- - doxepin to evaluate H@ RO in @ healthy males ( mean age @ years ) , after single oral administration of bilastine ( @mg ) , hydroxyzine ( @mg ) or placebo .


Binding potentials and H@ ROs were calculated in five cerebral cortex regions of interest : frontal , occipital , parietal , temporal , insula .


Plasma bilastine concentrations , subjective sedation ( visual analogue scale ) , objective psychomotor performance ( digital symbol substitution test ) , physiological variables and safety ( adverse events , AEs ) , were also evaluated .


The mean binding potential of all five regions of interest ( total binding potential ) was significantly greater with bilastine than hydroxyzine ( mean value @ vs. @ , P < @ ; mean difference and @ % CI -@ -LSB- -@ , @ -RSB- ) .


There was no significant difference between bilastine and placebo .


Overall H@ RO by bilastine was significantly lower than that by hydroxyzine ( mean value -@ % vs. @ % , P < @ ; mean difference and @ % CI @ % -LSB- @ % , @ % -RSB- ) .


There was no significant linear relationship between individual bilastine plasma concentrations and total binding potential values .


No significant between-treatment differences were observed for sedation and psychomotor performance .


Twenty-six non-serious AEs were reported .


Sleepiness or sedation was not reported with bilastine but appeared in some subjects with hydroxyzine .


A single oral dose of bilastine @mg had minimal H@ RO , was not associated with subjective sedation or objective impairment of psychomotor performance and was devoid of treatment-related sedative AEs , thus satisfying relevant subjective , objective and PET criteria as a non-sedating antihistamine .


The Whole Systems Demonstrator was a large , pragmatic , cluster randomised trial that compared telehealth with usual care among @,@ patients with long-term conditions in three areas of England .


Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely .


We examined whether telehealth led to changes in glycosylated haemoglobin ( HbA@c ) among the subset of patients with type @ diabetes .


The general practice electronic medical record was used as the source of information on HbA@c .


Effects on HbA@c were assessed using a repeated measures model that included all HbA@c readings recorded during the @-month trial period , and adjusted for differences in HbA@c readings recorded before recruitment .


Secondary analysis averaged multiple HbA@c readings recorded for each individual during the trial period .


@ of the @,@ participants were identified as having type @ diabetes and thus were included in the study .


Telehealth was associated with lower HbA@c than usual care during the trial period ( difference @ % or @ mmol/mol , @ % CI , @ % to @ % , p = @ ) .


Among the @ patients in the secondary analysis , mean HbA@c showed little change for controls following recruitment , but fell for intervention patients from @ % to @ % ( @ to @ mmol/mol ) .


A higher proportion of intervention patients than controls had HbA@c below the @ % ( @ mmol/mol ) threshold that was targeted by general practices ( @ % vs. @ % ) .


This difference , however , did not quite reach statistical significance ( adjusted odds ratio @ , @ % CI , @ to @ , p = @ ) .


Telehealth modestly improved glycaemic control in patients with type @ diabetes over @ months .


The scale of the improvements is consistent with previous meta-analyses , but was relatively modest and seems unlikely to produce significant patient benefit .


To evaluate the effect of calorie restriction-induced weight loss with or without aerobic exercise on liver fat .


Thirty-three adults with visceral adiposity were divided into calorie restriction ( CR ; n = @ ) or CR and aerobic exercise ( CR + Ex ; n = @ ) groups .


Target energy intake was @kcal/kg of ideal body weight .


The CR + Ex group had a targeted exercise time of @min/wk or more at lactate threshold intensity for @ weeks .


Reductions in body weight ( CR , -@ @ kg ; CR + Ex , -@ @ kg ) , fat mass ( CR , -@ @ kg ; CR + Ex , -@ @ kg ) , and visceral fat ( CR , -@ @cm@ ; CR + Ex , -@ @cm@ ) were not statistically different between groups .


Liver fat decreased significantly in both groups , with no difference between groups .


Change in maximal oxygen uptake was significantly greater in the CR + Ex group than in the CR group ( CR , -@ @ mL/kg/min ; CR + Ex , @ @ mL/kg/min ) .


Both CR and CR + Ex resulted in an improved reduction in liver fat ; however , there was no additive effect of exercise training .


One hypothesis suggests that the differential response to ondansetron - and serotonin-specific re-uptake inhibitors ( SSRIs ) may be due to a functional polymorphism of the @ ' - HTTLPR promoter region in SLC@A@ , the gene that codes for the serotonin transporter ( @-HTT ) .


The LL @ ' - HTTLPR genotype is postulated to be specifically sensitive to the effects of ondansetron with SS/SL @ ' - HTTLPR genotypes sensitive to SSRIs .


This study tests this hypothesis by matching nontreatment-seeking alcohol-dependent ( AD ) individuals with LL genotype to ondansetron and SS/SL genotypes to the SSRI sertraline , and mismatching them assessing naturalistic and bar-laboratory alcohol drinking .


Seventy-seven AD individuals were randomized to @ of @ counterbalanced arms to receive sertraline @ mg/d or ondansetron @ mg/d for @ weeks followed by an alcohol self-administration experiment ( ASAE ) and then received placebo for @ weeks followed by a second ASAE .


Individuals then received the alternate drug for @ weeks followed by a third ASAE .


Drinks per drinking day ( DDD with drinks in standard drinking units ) for @ days prior to each ASAE and milliliters consumed during each ASAE were the primary outcomes .


Fifty-five participants completed the study .


The genotype order interaction was significant , F ( @ , @ ) = @ , p = @ , for DDD .


Three analyses of covariance were conducted for DDD during the week before each ASAE .


Ondansetron compared to sertraline resulted in a significant reduction in DDD during the week before the first , F ( @ , @ ) = @ , p = @ , but not the third ASAE .


There was no difference in milliliters consumed during each ASAE .


This study modestly supports the hypothesis that ondansetron may reduce DDD in AD individuals with the LL genotype as measured naturalistically .


By contrast , there was no support that ondansetron reduces drinking during the ASAEs or that sertraline reduces alcohol use in individuals who have SS/SL genotypes .


We provide limited support that ondansetron may reduce drinking in nontreatment-seeking individuals with the LL genotype .


No interventions have yet been identified to reduce the risk of acute kidney injury in the setting of cardiac surgery .


To determine whether remote ischemic preconditioning reduces the rate and severity of acute kidney injury in patients undergoing cardiac surgery .


In this multicenter trial , we enrolled @ patients at high risk for acute kidney injury , as identified by a Cleveland Clinic Foundation score of @ or higher , between August @ and June @ at @ hospitals in Germany .


We randomized them to receive remote ischemic preconditioning or sham remote ischemic preconditioning ( control ) .


All patients completed follow-up @ days after surgery and were analyzed according to the intention-to-treat principle .


Patients received either remote ischemic preconditioning ( @ cycles of @-minute ischemia and @-minute reperfusion in one upper arm after induction of anesthesia ) or sham remote ischemic preconditioning ( control ) , both via blood pressure cuff inflation .


The primary end point was the rate of acute kidney injury defined by Kidney Disease : Improving Global Outcomes criteria within the first @ hours after cardiac surgery .


Secondary end points included use of renal replacement therapy , duration of intensive care unit stay , occurrence of myocardial infarction and stroke , in-hospital and @-day mortality , and change in acute kidney injury biomarkers .


Acute kidney injury was significantly reduced with remote ischemic preconditioning ( @ of @ patients -LSB- @ % -RSB- ) compared with control ( @ of @ patients -LSB- @ % -RSB- ; absolute risk reduction , @ % ; @ % CI , @ % -@ % ; P = @ ) .


Fewer patients receiving remote ischemic preconditioning received renal replacement therapy ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; absolute risk reduction , @ % ; @ % CI , @ % -@ % ; P = @ ) , and remote ischemic preconditioning reduced intensive care unit stay ( @ days -LSB- interquartile range , @-@ -RSB- ) vs @ days ( interquartile range , @-@ ) ( P = @ ) .


There was no significant effect of remote ischemic preconditioning on myocardial infarction , stroke , or mortality .


Remote ischemic preconditioning significantly attenuated the release of urinary insulinlike growth factor-binding protein @ and tissue inhibitor of metalloproteinases @ after surgery ( remote ischemic preconditioning , @ vs control , @ ng/mL@/@ ; difference , @ ; @ % CI , @-@ @ ; P < @ ) .


No adverse events were reported with remote ischemic preconditioning .


Among high-risk patients undergoing cardiac surgery , remote ischemic preconditioning compared with no ischemic preconditioning significantly reduced the rate of acute kidney injury and use of renal replacement therapy .


The observed reduction in the rate of acute kidney injury and the need for renal replacement warrants further investigation .


Parasitological confirmation is now recommended for all cases of suspected malaria .


The roll-out of rapid diagnostic tests ( RDTs ) is hoped to enable this goal in low resource settings through point of care testing .


However , simply making RDTs available has not led to high uptake of the tests or adherence to results by clinicians , with malaria continuing to be overdiagnosed in many settings .


We undertook to design an evidence-based intervention package that would be sufficient to support the introduction of RDTs at dispensaries in Tanzania , to be evaluated through the Targeting Artemisinin Combination Therapy ( TACT ) cluster randomised controlled trial .


We describe five steps in our intervention design : formative research , review of existing evidence and theory , a workshop to define the intervention approach and content and results of formative research , engagement with behaviour change theory and literature , detailed design of intervention materials and piloting and pretesting of intervention materials .


This involved fieldwork with a total of @ health workers and @ community members in northeast Tanzania .


The formative research suggested that RDTs were a potential source of conflict in the health worker-patient interaction , but that health workers used various techniques to resolve this , including provision of antimalarial drugs for RDT-negative patients .


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 .


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 @ 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 @ and @ 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 @ cm ( @ ) ( @-@ @ ) to @ cm ( @ ) ( @-@ @ ) was found at @ months ( p = @ ) and at @ months postoperatively ( @ cm ( @ ) ( @-@ @ ) to @ cm ( @ ) ( @-@ @ ) , p = @ , 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 ; @ 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 = @ ) .


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 < @ ) .


Side effects such as nausea ( P = @ ) , vomiting ( P = @ ) , headache ( P = @ ) and bloating ( P < @ ) 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 @-minute psychotherapeutic microintervention in a dysphoric sample .


Participants ( N = @ ) 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 @ adult patients with subjective tinnitus of cochlear origin were randomly assigned to receive postaurical subcutaneous.Injection of either triamcinolone acetonide ( n = @ ) or saline solution ( n = @ ) .


The treatment protocol comprised @ injections , one per week for @ 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 @ 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 = @,@,@,@ and @ respectively ) .


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


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 @ 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 @-@ @ % , 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 @ adult internal medicine patients receiving vancomycin treatment with mean baseline creatinine clearance of @ ml/min .


Vancomycin treatment for a minimum of @hours .


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


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


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


Nephrotoxicity developed at a median of @ days ( interquartile range -LSB- IQR -RSB- @-@ @ ) peaked at @ days ( IQR : @-@ @ ) , and resolved in @ % of the cases within @ days ( IQR : @-@ @ ) 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 @ , @ % confidence interval @-@ @ ) .


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


To explore the prognostic and/or predictive value of human epidermal growth factor receptor @ ( HER@ ) 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 HER@-positive metastatic breast cancer .


Mandatory tumor and serum samples were collected ( N = @ ; @ % to @ % were assessable ) , and amphiregulin , betacellulin , epidermal growth factor ( EGF ) , transforming growth factor alpha , EGF receptor , HER@ , HER@ , insulin-like growth factor @ receptor , PTEN , phosphorylated AKT , PIK@CA , CMYC , serum HER@ extracellular domain ( sHER@ ) , 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 -LSB- PFS -RSB- 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 < @ ) , including estrogen receptor-negative and - positive subgroups .


High HER@ protein , high HER@ and HER@ mRNA levels , wild-type PIK@CA , and low sHER@ showed a significantly better prognosis ( P < @ ) .


PIK@CA showed the greatest prognostic effect , with longer median PFS for patients whose tumors expressed wild-type versus mutated PIK@CA in both the control ( @ v @ months ) and pertuzumab groups ( @ v @ months ) .


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


HER@ , HER@ , and PIK@CA 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 , @years ; duration of type @ diabetes mellitus , @ years , @ male , @ female ; HbA@c , @ mmol/mol ; meanSD ) were randomized to receive linagliptin @mg ( n = @ ) or glimepiride ( n = @ ) for a study duration of @weeks .


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


The areas under the curve ( AUC@-@min ) were calculated for group comparisons .


HbA@c , fasting and postprandial glucose levels improved in both groups .


An increase in postprandial insulin ( @pmol/L * min ) , postprandial intact proinsulin ( @pmol/L * min ) , postprandial glucagon ( @pg/mL * min ) and postprandial PAI-@ levels ( @ng/mL * min ) could be observed during treatment with glimepiride , whereas treatment with linagliptin was associated with a decrease in postprandial insulin ( -@ pmol/L * min ) , intact proinsulin ( -@ pmol/L * min ) , postprandial glucagon ( -@ pg/mL * min ) and PAI-@ levels ( -@ 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 .


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


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


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


HR , mean arterial pressure ( MAP ) , heart rate ( HR ) , breathing rate ( RR ) , pulse oxygen saturation ( SpO@ ) 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 @ 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 , SpO@ , operation time and postoperative recovery time between the two groups ( P > @ ) .


Compared with control group , HR during the operation were decreased significantly -LSB- ( @ + / - @ ) bpm , P < @ -RSB- in observation group .


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


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


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


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 @ patients with chronic rhinosinusitis and bilateral NP were randomized into @ study arms , @ patients in each arm .


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


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


Patient assessment was conducted before the surgery and @ , @ , and @ weeks after surgery , using a visual analogue scale ( VAS ) , @-item SinoNasal Outcome Test ( SNOT-@ ) , 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 @ and @ 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 @ 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 @ and @ .


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


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


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


Cumulative tracheal colonization greater than @ ( @ ) cfu/ml at Day @ was as follows ( median -LSB- interquartile range -RSB- ) : cylindrical polyvinyl chloride , @ ( @-@ @ ) ; cylindrical polyurethane , @ ( @-@ @ ) ; conical polyvinyl chloride , @ ( @-@ @ ) ; and conical polyurethane , @ ( @-@ @ ) ( P = @ ) .


VAP developed in @ patients ( @ % ) , and postextubational stridor developed in @ patients ( @ % ) ( P = @ and @ 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 ( NCT@ ) .


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


The study was performed in @ 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 WB@ , L. salivarius TI @ , 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 WB@-containing tablets was performed in eight healthy volunteers .


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


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


Lactobacilli levels significantly increased in the L. salivarius WB@ and TI @ 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 @ group ( P = @ ) and Ovalgen DC group ( P = @ ) compared to the xylitol group .


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


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


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


Weight , depression , anti-depressant use ( ADMs ) , and stress ( baseline , @ months , @ and @ 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 @ % reported EDS , with no change over time .


Approximately @ % of all participants used ADMs .


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


Participants with EDS were less likely to be `` completers '' ( @ % vs. @ % , P = @ ) , coached ( @ % vs. @ % , P = @ ) , or log diet/activity ( @ % vs. @ % , P < @ ) , 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 @ 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 @ mm ( n = @ ) at @ months and -@ mm ( n = @ ) at @ months .


A decrease in LDL-C was found to be associated with a smaller change in the mean IMT ( p = @ ; 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 = @ ) was treated with standard therapy ( antibiotherapy + nasal decongestant ) for @ weeks , the second group was treated with the large volume low pressure nasal saline + fluticasone propionate combination for @ 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 @ improved more rapidly , there were no significant differences in between groups regarding clinical scores by the @st 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 @ than in Group @ .


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


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


The values of hematologic parameters were significantly reduced at the end of the @rd 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 @ groups of low immunological risk kidney allograft recipients receiving @ TAC dosages .


Patients were randomly assigned to @ TAC-based treatments ( group I -LSB- n = @ -RSB- , standard dose ; group II -LSB- n = @ -RSB- , 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 @-year period .


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


TAC trough levels were significantly higher in group I for @ 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 @ 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 @-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 = @ ) 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 -LSB- NW -RSB- ) 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-@ ( SF-@ ) , and Impact of Event Scale ( IES ) at baseline and @ , @ , and @ months after the intervention .


The mean age of participants ( @ % stage IV ; @ % female ) was @ years .


Multilevel modeling analyses , using a Bonferroni-corrected = @ 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 = @ ) and higher physical component summary scores on the SF-@ ( P = @ ) at @ months after the intervention .


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


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


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 @ 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 , @ impressions were taken in @ patients .


Two plaster impressions failed .


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


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


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


The discrepancy between the casts was @ @ mm ( P = @ ) .


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 @ of the @ patients ( @ in restorations fabricated onto the plaster cast group and @ in the splinted-VPS cast group ) with no effect from the type of impression on the prosthetic success rate ( P = @ ) .


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


Furthermore , mean MBL , SBI and PS showed no significant differences ( P > @ ) 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 .


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 @ 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 @ weeks .


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


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


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 = @ ) 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 @ clinical trials .


MSQOL was prospectively evaluated in @ 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 @ mg/BZA @mg and CE @ mg/BZA @mg 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 ( -@ to -@ over @-@ months ) and total scores ( -@ to -@ ) in the general and symptomatic VMS/VVA populations .


Significant improvement compared with placebo in sexual domain ( -@ to -@ ) was observed with the higher dosage for all populations , and with the lower dosage in the VVA ( -@ at month @ ) and general populations ( -@ at months @ and @ ) .


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 @ conventional HD ( HD ) sessions and then switched to @ 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 : @ and @ vs. HD-BVT : @ and @ , respectively , for both p < @ ) .


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


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 @ prospective , open-label , randomized clinical trials ( ECLIPSE trials ) .


Sixty-one medical centers in the United States .


Patients @ years or older undergoing cardiac surgery .


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


The ECLIPSE trials included @ 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 AUC@ mmHgmin/h compared to patients with AUC > @ mmHgmin/h .


One thousand four hundred ten patients were included for analysis ; @ patients ( @ % ) had an AUC@ mmHgmin/h , and @ ( @ % ) had an AUC > @ mmHgmin/h .


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


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


Multivariate analysis demonstrates AUC@ was significantly and independently associated with decreased time to extubation ( hazard ratio @ , p = @ ) and postoperative LOS ( hazard ratio @ , p = @ ) .


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 @-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 @-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 @-month remission by @ 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 @-month remission .


Approximately @ % 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 @-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 @ of inclination or @ 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 @-hydroxycholecalciferol -LSB- @ ( OH ) D -RSB- through dietary supplementation enhances breast meat yield in broiler chickens .


However , the underlying molecular mechanisms are still unknown .


We investigated the effect of @ ( 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 @ broiler chickens were divided into @ body weight-matched groups and received a control diet with normal cholecalciferol ( @ IU/kg feed ) for @ d , a diet with high concentrations of cholecalciferol ( @ IU/kg feed ) for @ d , or a diet with @ ( OH ) D ( @ IU/kg feed ) for @ d ( HyD-@ ) .


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


Food and clean water were available for ad libitum consumption .


At the end of the @-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 ( QM@ ) cell line .


QM@ cells were treated with @ doses ( @ nM and @ nM ) of cholecalciferol or @ ( OH ) D alone or in combination with @ nM rapamycin , and cell proliferation was determined by cell proliferation assay .


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


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


Molecular analyses revealed that breast muscle from chickens consuming the HyD-@ expressed significantly higher concentrations of vitamin D receptor ( VDR ) , phospho mechanistic target of rapamycin ( Ser@ ) , phospho ribosomal P@ S@ kinase ( RPS@K ) ( Thr@/Ser@ ) , and antigen Ki-@ ( Ki@ ) compared with the other groups .


In line with the in vivo data , in vitro functional studies showed that cells treated with @ ( OH ) D for @ h had increased VDR expression , and activated the mechanistic target of rapamycin ( mTOR ) / S@ kinase ( S@K ) pathway , enhanced Ki@ protein concentrations , and induced QM@ 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 @ ( OH ) D on male broiler breast muscle are likely mediated through the mTOR-S@K pathway .


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


Prospective , double-blind , randomized controlled multicenter trial .


Controlled trials.com/ISRCTN@ .


Twenty-eight level @ German PICUs/neonatal ICUs .


Ventilated newborns and infants : stratum I ( @-@ d ) , stratum II , ( @-@ d ) , and stratum III ( @ d to @ yr ) .


Patients received clonidine @ g/kg/hr or placebo on day @ 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 ; @ received study medication , @ % were ventilated in the postoperative care and @ % for other reasons .


Primary endpoint : consumption of fentanyl and midazolam in the @ 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 = @ ) the clonidine group had a significantly lower consumption of fentanyl ( clonidine : @ @ g/kg/hr , placebo : @ @ g/kg/hr ; p = @ ) and midazolam ( clonidine : @ @ g/kg/hr , placebo : @ @ g/kg/hr ; p = @ ) .


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


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


Frequency of severe adverse events did not differ between groups .


Clonidine @ 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 @-@ weeks after the intervention period .


Four primary healthcare centres in rebro County Council .


Persons more than six months post stroke , with walking ability of @ 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 , @-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 @ ( SF-@ ) questionnaire .


A total of @ participants were included ( mean age @ years ) ; @ in the experimental intervention group and @ 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 @-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 = @ ) will be recruited and randomised to one of the two conditions .


Primary outcome will be observer-rated depressive symptoms ( HRSD-@ ) 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 , @ and @ 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 .


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 @ , @ , and February @ , @ , among @ uncircumcised men aged @ to @ years in Nyanza region , Kenya .


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


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


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


The control group received no compensation .


VMMC uptake within @ months .


Analysis of data for @ participants with complete data showed that VMMC uptake within @ months was higher in the US $ @ group ( @ % ; @ % CI , @ % -@ % -LSB- @ of @ -RSB- ) and the US $ @ group ( @ % ; @ % CI , @ % -@ % -LSB- @ of @ -RSB- ) than in the US $ @ group ( @ % ; @ % CI , @ % -@ % -LSB- @ of @ -RSB- ) and the control group ( @ % ; @ % CI , @ % -@ % -LSB- @ of @ -RSB- ) .


In logistic regression analysis , the US $ @ group had significantly higher VMMC uptake than the control group ( adjusted odds ratio -LSB- AOR -RSB- @ ; @ % CI , @-@ @ ) , as did the US $ @ group ( AOR @ ; @ % CI , @-@ @ ) .


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


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


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


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 ( @ ) quantifying improvements in trunk control ; ( @ ) measuring responses to a standardized perturbation ; and ( @ ) demonstrating retention at @ and @ months after training .


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


Fourteen male military service members ( @ @ years ) with unilateral transtibial amputations and who had been walking without an assistive device for a median of @ months ( range , @-@ 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 @-minute sessions delivered over a @-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 ( @ months ) as well as both @ and @ 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 ( @ ; @ % confidence interval -LSB- CI -RSB- , @-@ ) to after training ( @ ; @ % CI , @-@ ; p < @ ) .


Likewise , the trunk flexion velocity improved from pretraining ( @/sec ; @ % CI , @-@ ) to after training ( @/sec ; @ % CI , @-@ ; p < @ ) .


The results display a significant side-to-side difference for peak trunk flexion angle ( p = @ ) 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 = @ ) .


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


The peak trunk flexion angle of the subjects when the prosthetic limb was perturbed had a mean of @ ( @ % CI , @-@ ) at @ month , @ ( @ % CI , @-@ ) at @ months , and @ ( @ % CI , @-@ ) at @ months .


Likewise , the peak trunk flexion velocity for the prosthetic limb was a mean of @/sec ( @ % CI , @-@ ) at @ months , @/sec ( @ % CI , @-@ ) at @ months , and @ ( @ % CI , @-@ ) at @ months .


The peak trunk flexion angle when the nonprosthetic limb was perturbed had a mean of @ ( @ % CI , @-@ ) at @ months , a mean of @ ( @ % CI , @-@ ) at @ months , and a mean of @ ( @ % CI , @-@ ) at @ months .


The peak trunk flexion velocity for the nonprosthetic limb had a mean of @/sec ( @ % CI , @-@ ) at @ months , a mean of @ ( @ % CI , @-@ ) at @ months , and @/sec ( @ % CI , @-@ ) at @ months .