Because dementia patients have a diminished capacity to communicate discomfort , untreated pain may be expressed in the form of behavioral and psychiatric symptoms .


The goal of the present study was to examine the relationship between pain and behavioral and psychiatric symptoms of dementia in community-residing older adults from the perspective of the family caregiver .


Dyads composed of @ dementia patients , and their family caregivers were assessed to determine dementia patient 's mental status ; family caregiver 's assessment of care recipient 's pain , functional dependence , and number of behavioral symptoms ; analgesic use ; and demographic information .


Hierarchical multiple regression analysis controlling for age , marital status , race , functional disability , and analgesic use showed that pain explained a small but significant percent of variance in the number of behavioral symptoms ( @ % , P < @ ) .


Pain had a stronger influence on the number of behavioral and psychiatric symptoms of dementia among those with severe cognitive impairment ( F@ ,@ = @ , P < @ ) compared with those with low to moderate cognitive impairment ( F@ ,@ = @ , P = @ . )


The findings indicate that pain is a risk factor for behavioral symptoms in individuals with dementia and suggest that pain is a more significant predictor of behavior for individuals with severe dementia , compared with those with mild/moderate stage dementia .


These results reinforce the importance of proper pain assessment and its management as part of dementia care planning .


T-cell infiltration in estrogen receptor ( ER ) - negative breast tumours has been associated with longer survival .


To investigate this association and the potential of tumour T-cell infiltration as a prognostic and predictive marker , we have conducted the largest study of T cells in breast cancer to date .


Four studies totalling @ @ patients were used for this work .


Cytotoxic ( CD@ + ) and regulatory ( forkhead box protein @ , FOXP@ + ) T cells were quantified using immunohistochemistry ( IHC ) .


IHC for CD@ was conducted using available material from all four studies ( @ samples ) and for FOXP@ from three studies ( @ samples ) - multiple imputation was used to resolve missing data from the remaining patients .


Cox regression was used to test for associations with breast cancer-specific survival .


In ER-negative tumours -LSB- triple-negative breast cancer and human epidermal growth factor receptor @ ( human epidermal growth factor receptor @ ( HER@ ) positive ) -RSB- , presence of CD@ + T cells within the tumour was associated with a @ % -LSB- @ % confidence interval ( CI ) @ % to @ % -RSB- reduction in the hazard of breast cancer-specific mortality , and CD@ + T cells within the stroma with a @ % ( @ % CI @ % to @ % ) reduction in hazard .


In ER-positive HER@-positive tumours , CD@ + T cells within the tumour were associated with a @ % ( @ % CI @ % to @ % ) reduction in hazard .


In ER-negative disease , there was evidence for greater benefit from anthracyclines in the National Epirubicin Adjuvant Trial in patients with CD@ + tumours -LSB- hazard ratio ( HR ) = @ ; @ % CI @-@ @ -RSB- versus CD@-negative tumours ( HR = @ ; @ % CI @-@ @ ) .


The difference in effect between these subgroups was significant when limited to cases with complete data ( P heterogeneity = @ ) and approached significance in imputed data ( P heterogeneity = @ ) .


The presence of CD@ + T cells in breast cancer is associated with a significant reduction in the relative risk of death from disease in both the ER-negative -LSB- supplementary Figure S@ , available at Annals of Oncology online -RSB- and the ER-positive HER@-positive subtypes .


Tumour lymphocytic infiltration may improve risk stratification in breast cancer patients classified into these subtypes .


NEAT ClinicalTrials.gov : NCT@ .


To study the influence of adjuvant androgen suppression and bisphosphonates on incident vertebral and non-spinal fracture rates and bone mineral density ( BMD ) in men with locally advanced prostate cancer .


Between @ and @ , @ men with locally advanced prostate cancer were randomly allocated , using a @ @ trial design , to @ months i.m. leuprorelin ( androgen suppression -LSB- AS -RSB- ) before radiotherapy alone @ months additional leuprorelin @ months zoledronic acid ( ZdA ) , commencing at randomization .


The main endpoint was incident thoraco-lumbar vertebral fractures , which were assessed radiographically at randomization and at @ years , then reassessed by centralized review .


Subsidiary endpoints included incident non-spinal fractures , which were documented throughout follow-up , and BMD , which was measured in @ subjects at baseline , @ years and @ years .


Incident vertebral fractures at @ years were observed in @ subjects .


Their occurrence was not increased by @ months ' AS , nor reduced by ZdA .


Incident non-spinal fractures occurred in @ subjects and were significantly related to AS duration but not to ZdA .


Osteopenia and osteoporosis prevalence rates at baseline were @ and @ % , respectively , at the hip .


Treatment for @ and @ months with AS caused significant reductions in hip BMD at @ and @ years ( P < @ ) and ZdA prevented these losses at both time points .


In an AS-nave population , @ months of ZdA treatment prevented the sustained BMD losses caused by @ months of AS treatment ; however , the study power was insufficient to show that AS duration or ZdA influenced vertebral fracture rates .


Febrile neutropenia ( FN ) is a common and serious complication of cancer chemotherapy associated with significant morbidity and mortality .


Cefozopran ( CZOP ) is a potential candidate for empirical monotherapy in FN .


However , studies on the use of CZOP as empirical treatment for pediatric patients with FN are quite limited .


The purpose of this study was to compare the efficacy and safety of CZOP with cefepime ( CFPM ) empirical monotherapy in pediatric cancer patients with FN .


A total of @ patients with @ episodes of FN were randomly assigned to receive antibiotic therapy with either CZOP ( @ mg/kg/day ) or CFPM ( @ mg/kg/day ) .


Of these episodes , @ were considered eligible for the study .


Success was defined as resolution of febrile episodes and clinical signs of infection within @ hr following the start of antibiotic therapy .


The success rate was not significantly different between the CZOP ( @ % ) and CFPM ( @ % ) groups ( P = @ ) .


Duration of fever , duration of antibiotic therapy , and the success rate in patients with blood stream infection did not differ between the two groups .


There was no infection-related mortality in the study period .


Both CZOP and CFPM as monotherapy appear to be effective and safe in pediatric patients .


This study suggests that CZOP has satisfactory efficacy and is well tolerated as initial empirical therapy for pediatric cancer patients with FN .


Obstructive sleep apnea ( OSA ) relates to overnight rostral fluid shift , possibly because fluid accumulation around the pharynx increases pharyngeal resistance ( Rph ) .


We hypothesised that Rph will increase more in men with than without OSA in response to rostral fluid redistribution .


Seventeen men with , and @ without OSA were randomized to lower body positive pressure ( LBPP ) for @min or control , then crossed over .


Leg fluid volume ( LFV ) and Rph were measured before and after each period .


LBPP displaced similar amounts of fluid from the legs in both groups .


However , compared to the non-OSA group , Rph increased significantly more during LBPP in the OSA group ( -@ vs. @ cmH@O/l/s , p = @ ) .


Change in Rph during LBPP correlated directly with baseline Rph in the OSA group , but inversely in the non-OSA group .


OSA patients have increased susceptibility to pharyngeal obstruction in response to rostral fluid redistribution , which could predispose to pharyngeal collapse during sleep .


To investigate whether a virtual reality simulator ( LapSim ) and traditional box trainer are effective tools for the acquisition of basic laparoscopic skills , and whether the LapSim is superior to the box trainer in surgical education .


In a study at Ege University School of Medicine , Izmir , Turkey , between September @ and March @ , @ first - and second-year residents were randomized to train via the LapSim or box trainer for @ weeks , and @ senior residents were allocated to a control group .


All @ groups performed laparoscopic bilateral tubal ligation .


Video records of each operation were assessed via the general rating scale of the Objective Structured Assessment of Laparoscopic Salpingectomy and by operation time in seconds .


Compared with the control group , the LapSim and box trainer groups performed significantly better in total score ( P < @ and P < @ , respectively ) and time ( P = @ and P = @ , respectively ) .


There were no differences between the LapSim and box trainer groups .


Novice residents who trained on a LapSim or box trainer performed better live laparoscopies than residents who trained via standard clinical surgical education .


Training with a virtual reality simulator or box trainer should be considered before actual laparoscopic procedures are carried out .


Acupuncture has been used in China to treat tinnitus for a long time .


There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture .


However , there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus .


This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective , double-blind , randomized , sham-controlled trial .


This study compares two acupuncture groups ( with or without manipulation ) in @ patients with a history of subjective tinnitus .


The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine .


In the study , the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment .


Then , they will receive @ daily sessions of @ minutes each time for @ consecutive weeks and undergo a @-week follow-up phase .


The administration of acupuncture follows the guidelines for clinical research on acupuncture ( WHO Regional Publication , Western Pacific Series Number @ , @ ) , and is performed double-blind by physicians well-trained in acupuncture .


The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales ( VAS ) and the Chinese version of the ` modified ' Massachusetts General Hospital Acupuncture Sensation Scale ( C-MMASS ) .


Furthermore , adverse events are recorded and analyzed .


If any subjects are withdrawn from the trial , intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed .


The key features of this trial include the randomization procedures , large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus .


The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized , double-blind , sham-controlled manner .


To evaluate the protective effects of oral administration of D-methionine tablets on noise-induced hearing impairment .


Two hundred and three volunteers were recruited and randomly divided into two groups : experimental group ( n = @ ) and control group ( n = @ ) .


The subjects received oral administration of D-methionine tablets in the experimental group and placebo in the control group before noise exposure .


Routine audiometric evaluation and ABR testing were performed and recorded before and after noise exposure .


The statistical analysis was carried out with SPSS @ .


There were no differences in auditory threshold and I-V interpeak latency pre-noise exposure ( P > @ ) , however , there were statistically significant differences between two groups @ d , @ d after noise exposure ( P < @ and P < @ ) .


In-respective-group , there were statistically significant differences between before and @ d after noise exposure ( P < @ and P < @ ) , however , no difference was noted between before and @ d after noise exposure in the experimental group ( P > @ ) .


The protective effects of D-methionine tablets were prominent on the noise-induced hearing impairment .


Further studies regarding the optimal time of D-methionine administration will be recommended in the future .


Non-extensive superficial partial thickness burns constitute a major proportion of burns .


Conventional treatment involves regular changing of absorptive dressings including the application of a topical antimicrobial , commonly silver sulfadiazine .


A systematic review has found insufficient evidence to support or refute such antimicrobial prophylaxis .


Another review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial dressings and found insufficient evidence to guide practice .


Other research has suggested that dressings with petrolatum gel are as effective as silver sulfadiazine .


Single-center , randomized , controlled parallel group trial comparing conventional silver sulfadiazine dressings with treatment with petrolatum gel alone .


Consenting adults @-@ years old with superficial partial thickness burns@ % total body surface area seen within @h of the injury were randomized to daily dressing either with petrolatum gel without top dressings or conventional silver sulfadiazine treatment with gauze dressings .


Primary outcomes were blinded assessment of time to complete re-epithelialization , wound infection or allergic contact dermatitis .


Secondary outcomes included assessment of ease , time and pain of dressing changes .


@ patients were randomized to petrolatum and @ to silver sulfadiazine dressings .


Follow up data available for @ in each group .


Mean time to re-epithelialization was @ days ( SD @ ) in the petrolatum group and @ days ( SD @ ) in the silver sulfadiazine group ( p = @ ) .


No wound infection or dermatitis was observed in either group .


Scores for adherence to wound , ease of dressing removal and time required to change dressings were significantly better in the petrolatum treatment arm ( p < @ ) .


Petrolatum gel without top dressings may be at least as effective as silver sulfadiazine gauze dressings with regard to time to re-epithelialization , and incidence of infection and allergic contact dermatitis .


Petrolatum gel appears to be an effective , affordable and widely available alternative in the treatment of minor superficial partial thickness burns in adults .


Studies have demonstrated that both pain and opioids have actions on the central nervous system that may interfere with cognitive function , but their effects have mainly been analysed separately and not as an integrated process .


The objective of this study is to test two hypotheses : ( @ ) the analgesic effect of opioids improves cognitive function by decreasing pain , and ( @ ) pain antagonizes cognitive effects of opioids .


Randomized , placebo-controlled , crossover study .


Three experiments were conducted with @ healthy males .


Sustained attention , memory and motor function/attention/mental flexibility were evaluated by continuous reaction time ( CRT ) , verbal fluency test ( VFT ) and trail making test-B ( TMT-B ) , respectively .


In the @st experiment , the cognitive effects of experimental tonic pain of mild and moderate intensities produced by a computer-controlled pneumatic tourniquet cuff were assessed ; in the @nd , the effects of saline solution and remifentanil were assessed in the absence of pain ; and in the @rd experiment , the cognitive effects of moderate pain intensity relieved by remifentanil infusion were assessed followed by increasing pain to moderate intensity during a constant remifentanil infusion .


The first two experiments demonstrated that pain and remifentanil impaired CRT .


In the @rd experiment , remifentanil infusion relieving pain significantly impaired CRT and further deterioration was noted following increasing pain intensity .


Pain and remifentanil seemed to have additive deleterious cognitive effects .


This study represents an initial step to enhance our basic understanding of some of the cognitive effects following a painful stimulus and an opioid infusion separately and combined in a sequence comparable to clinical settings .


We sought to determine the feasibility of conducting percutaneous coronary intervention ( PCI ) in high-risk acute coronary syndrome ( ACS ) patients utilising the REG@ system consisting of pegnivacogin , an aptameric factor IXa inhibitor , and its controlling agent anivamersen .


In RADAR , ACS patients were randomised to pegnivacogin @ mg/kg with @ % , @ % , @ % , or @ % anivamersen reversal or unfractionated heparin .


Of the @ patients randomised , @ ( @ % ) underwent PCI .


Major modified ACUITY @-day bleeding rates were @ % ( @ % reversal ) , @ % ( @ % reversal ) , @ % ( @ % reversal ) , and @ % ( @ % reversal ) , compared with @ % with heparin .


The corresponding total bleeding rates were @ % , @ % , @ % , @ % , and @ % ( heparin ) .


Ischaemic events were less frequent in those receiving pegnivacogin versus heparin ( @ % vs. @ % , p = @ ) .


Thirty-day urgent TVR ( @ % vs. @ % , p = @ ) , myocardial infarction ( @ % vs. @ % , p = @ ) , and angiographic complication ( @ % and @ % , p = @ ) rates were similar with pegnivacogin and heparin .


There were no incidences of clot formation on guidewires or catheters .


High-level factor IXa inhibition in ACS patients undergoing PCI , with at least @ % reversal , has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications .


Larger phase trials in PCI are warranted .


Female pattern hair loss is a frequent and distressing condition .


To evaluate vs. control , the effects on hair loss of a @-month supplementation with specific omega @ & @ and antioxidants .


One hundred and twenty healthy female subjects participated in this @-month , randomized , comparative study .


The primary endpoint was the change in hair density evaluated on standardized photographs .


Secondary endpoints included changes in telogen hair percentage and diameter distribution of anagen hair ( > @m vs. @m ) measured by trichogram .


Overall changes in hair density and diameter were also measured by trichometer and by subjects ' self-assessment .


After @ months of treatment , photograph assessment demonstrated a superior improvement in the supplemented group ( P < @ ) .


The telogen hair percentage was significantly ( P < @ ) reduced in the supplemented group .


The proportion of nonvellus anagen hair ( > @m ) increased compared to the control group .


The trichometer index increased in the supplemented group , while it decreased in the control group .


A large majority of supplemented subjects reported a reduction in hair loss ( @ % of subjects at @months ) , as well as an improvement in hair diameter ( @ % ) and hair density ( @ % ) .


A @-month supplementation with omega @ & @ and antioxidants acts efficiently against hair loss in improving hair density and reducing the telogen percentage and the proportion of miniaturized anagen hair .


Objectively measured improvements were confirmed by the subjects ' perception of efficacy .


Sham-controlled low-frequency repetitive transcranial magnetic stimulation ( rTMS ) was used in patients with pharmacoresistant major depression as an added treatment along with partial sleep deprivation ( PSD ) .


In addition , the potential predictive role of brain-derived neurotrophic factor genetic polymorphism on treatment response was analyzed .


We recruited @ female patients ( @ @ years old ) with treatment-resistant unipolar major depression ( Hamilton Depression Rating Scale -LSB- HDRS -RSB- score @ ) who were on a stable antidepressant treatment .


They received either @-Hz rTMS or sham stimulation over the right dorsolateral prefrontal cortex ( intensity of @ % of the threshold ; @ stimuli per protocol ; and @ daily sessions ) .


Additionally , PSD was applied once per week during the treatment .


The patients were evaluated ( HDRS and Clinical Global Impression Scale ) by a blind rater at baseline ( B ) and after @ and @ weeks ( W@ and W@ ) of treatment for short-term outcome .


Long-term evaluations were performed after @ ( W@ ) and @ weeks ( W@ ) for patients who received active stimulation .


Eleven patients in the active group showed a significant HDRS score reduction from @ @ ( B ) to @ @ ( W@ ) compared to the lack of therapeutic response in the sham-treated patients .


The long-term follow-up for the active group included @ % of the responders at W@ and @ % at W@ .


Full remission ( HDRS @ ) was achieved in @ of @ patients .


Four of these @ patients with long-term sustained remission expressed the Val@Val genotype .


Our study suggests a clinically relevant response , persisting for up to @ months , from @-Hz rTMS over the right dorsolateral prefrontal cortex and PSD in patients with pharmacoresistant major depression .


The brain-derived neurotrophic factor Val@Val homozygous genotype may be related to a better treatment outcome .


Computer-assisted surgery plays an increasingly important role in mandibular reconstruction , ensuring the best possible masticatory function and aesthetic outcome .


Twenty patients were randomly assigned to computer-assisted or conventional mandibular reconstruction with vascularized iliac crest bone graft in a prospective study design.Virtual surgical planning was based on preoperative CT-data using specific surgical planning software .


A rapid prototyping guide transferred the virtual surgery plan to the operation site .


During surgery the transplant ischemic time , reconstruction time , time for shaping the transplant and amount of bone removed were measured .


Additionally , the difference in the intercondylar distance before and after surgery was calculated .


Computer-assisted surgery shortened the time of transplant ischemia ( P < @ ) and defect reconstruction ( P < @ ) compared to conventional surgery .


The time to saw and shape the transplant at the donor site was shorter using conventional surgery ( P < @ ) ; therefore , the overall time for surgery did n't change ( P = @ ) .


In the computer-assisted group , the amount of bone harvested equaled the defect size , whereas the transplant size in the conventional group exceeded the defect site by @ mm ( P < @ ) on average .


The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group ( P < @ ) .


The presented study shows that computer-assisted surgery can help reduce the time for mandibular defect reconstruction and consequently the transplant ischemic time .


In the computer-assisted group , the iliac crest donor site defect was downsized and the postoperative condyle position was less altered , reducing possible risks of postoperative complications and donor site morbidity .


The objectives of this study were to assess the efficacy of lifestyle intervention on gestational weight gain in pregnant women with normal and above normal body mass index ( BMI ) in a randomized controlled trial .


A total of @ pregnant women ( < @ weeks of pregnancy ) without diabetes were enrolled and @ pregnant women completed the program .


Participants were randomized into intervention and control groups .


Women in the intervention group received weekly trainer-led group exercise sessions , instructed home exercise for @-@-times / week during @-@ weeks of gestation , and dietary counseling twice during pregnancy .


Participants in the control group did not receive the intervention .


All participants completed a physical activity questionnaire and a @-day food record at enrolment and @ months after enrolment .


The participants in the intervention group with normal pre-pregnancy BMI ( @ kg/M@ , n = @ ) had lower gestational weight gain ( GWG ) , offspring birth weight and excessive gestational weight gain ( EGWG ) on pregnancy weight gain compared to the control group ( n = @ , p < @ ) .


Those weight related-changes were not detected between the intervention ( n = @ ) and control group ( n = @ ) in the above normal pre-pregnancy BMI participants .


Intervention reduced total calorie , total fat , saturated fat and cholesterol intake were detected in women with normal or above normal pre-pregnancy BMI compared to the control group ( p < @ or @ ) .


Increased physical activity and reduced carbohydrate intake were detected in women with normal ( p < @ ) , but not above normal , pre-pregnancy BMI at @ months after the onset of the intervention compared to the control group .


The results of the present study demonstrated that the lifestyle intervention program decreased EGWG , GWG , offspring birth weight in pregnant women with normal , but not above normal , pre-pregnancy BMI , which was associated with increased physical activity and decreased carbohydrate intake .


CPX-@ is a liposome-encapsulated fixed-molar-ratio formulation of cytarabine and daunorubicin that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy .


This phase II study randomized @ patients @:@ to CPX-@ or investigators ' choice of first salvage chemotherapy .


Patients with acute myeloid leukemia ( AML ) in first relapse after initial Complete Remission ( CR ) lasting @ month were stratified per the European Prognostic Index ( EPI ) into favorable , intermediate , and poor-risk groups based on duration of first CR , cytogenetics , age , and transplant history .


Control salvage treatment was usually based on cytarabine and anthracycline , often with @ or more additional agents .


Survival at @ year was the primary efficacy end point .


Patient characteristics were well balanced between the @ study arms .


Improvements in efficacy outcomes were observed following CPX-@ , but did not meet prospectively defined statistical criteria for @-year survival improvement in the overall population .


Subset analyses of the EPI-defined poor-risk strata demonstrated higher response rates ( @ % vs @ % ) and improvements in event-free survival ( HR , @ ; P = @ ) and overall survival ( HR , @ ; P = @ ) .


Also , @-day mortality was lower in the CPX-@ study arm for poor-risk patients ( @ % vs @ % ) .


Taken together , the data suggest possible improved outcomes in CPX-@-treated first relapse AML patients with EPI-defined poor-risk disease .


to compare the effects of pulsed electromagnetic field ( PEMF ) therapy and sham treatment on DOMS-related variables in elbow flexors at @ , @ and @ h after delayed onset muscle soreness ( DOMS ) induction exercise .


randomized , double-blind , placebo-controlled study .


Yonsei University laboratory .


In total , @ healthy male college students .


Muscle soreness , peak torque , median frequency ( MDF ) and electromechanical delay ( EMD ) during isometric contraction at @ , @ and @ h after DOMS induction exercise .


Overall , the application of the PEMF was found to be effective in reducing the physiological deficits associated with DOMS , including improved recovery of perceived muscle soreness , MDF , and EMD during isometric contraction .


Our results did not show that PEMF treatment was mechanically more effective for isometric peak torque generation compared to the sham group .


this study indicates that PEMF may be useful as a modality to reduce DOMS symptoms .


However , further well-designed experiments are required to determine optimal treatment dosage and duration , and to investigate the physiological and clinical mechanisms of PEMF on DOMS .


Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) .


The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration .


Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury .


High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing .


This study assesses the impact of ( @ ) treadmill-based SET alone ; and ( @ ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity .


Thirty-five patients with IC were randomised to @ weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) .


PFWD via a @-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed .


Intention-to-treat analyses revealed PFWD improved within group A ( @ m to @ m , p = @ ) , but not group B ( @ m to @ m , p = @ ) .


There was no between group difference ( p = @ ) .


Calpain activity increased within group A ( @ @ ( @ ) fluorescent units -LSB- FU -RSB- to @ @ ( @ ) FU , p = @ ) , but not group B.


SMM decreased within group A ( -@ g , p = @ ) and increased in group B ( @ g , p = @ ) ( p = @ between groups ) .


Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = @ ) .


Neither exercise regimen was superior in terms of walking performance .


Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET .


To observe the therapeutic effect and relevant mechanism of shuxuening Injection ( SI ) in treating patients with active ulcerative colitis ( UC ) .


Totally @ patients with active UC were randomly assigned to @ groups , @ in the control group and @ in the treatment group .


Patients in the control group received routine treatment , while patients in the treatment group additionally received intravenous injection of SI ( @ mL ) , twice daily for @ days in total .


Colonoscopy was performed before and after treatment .


The therapeutic effect was assessed by Mayo scoring system and the grading of activities evaluated by Baron endoscope .


Serum levels of IL-@ and TNF - were detected by ELISA .


The activity of SOD was detected by xanthine oxidase method .


The content of MDA was detected by thiobarbituricacid ( TBA ) .


Besides , @ healthy subjects were recruited as the healthy control group .


Totally @ patients completed the study ( @ in the control group and @ in the treatment group ) .


There was no statistical difference in serum levels of IL-@ , TNF - , SOD , MDA , the Mayo score and endoscope grading between the two groups before treatment ( P > @ ) .


Compared with the healthy control group , serum levels of IL-@ , TNF - , MDA significantly increased ( P < @ ) , and the serum SOD level decreased ( P < @ ) in the treatment grup and the control group before treatment .


Compared with before treatment in the same group , serum levels of IL-@ , TNF - , MDA , the Mayo score and endoscope grading all decreased in the treatment group and the control group after treatment ( P < @ , P < @ ) .


Compared with the control group after treatment , serum levels of IL-@ , TNF - , MDA , the Mayo score and endoscope grading all decreased ( P < @ , P < @ ) , the serum SOD level increased ( P < @ ) in the treatment group after treatment .


The serum SOD level was obviously negative correlated with serum levels of IL-@ , TNF-a , Mayo score , and endoscope score ( r = -@ , -@ , -@ , -@ , P < @ ) .


The serum MDA level was obviously positive correlated with serum levels of IL-@ , TNF - , Mayo score , and endoscope score ( r = @ , @ , @ , @ , P < @ ) .


SI could improve inflammatory injury and clinical symptoms of patients with active UC , and its mechanism might be associated with antioxidant and scavenging oxygen free radicals .


To explored the effect of sildenafil in treatment of pregnant women with pulmonary arterial hypertension .


From January @ to November @ , @ pregnant women with pulmonary arterial hypertension ( PAH ) were randomly divided into group and control group .


@ cases with mild and @ cases with moderate PAH .


To treatment with low-flow oxygen , low-salt diet therapy , cardiac , etc.sildenafil group : @ cases were mild pulmonary hypertension , and @ cases moderate PAH .


Treatment sildenafil @ mg , tid in this study .


Then the variation of the blood oxygen saturation , pulmonary artery systolic pressure , hemodynamic parameters and pregnancy outcome , including delivery modes , neonatal weight , morbidity of mother and fetus were compared .


( @ ) Cardiac function and pulmonary hypertension : control group : the proportion of cardiac functional class I-II reduced from @ % ( @/@ ) to @ % ( @/@ ) significantly after treatment ( P < @ ) .


Sildenafil group : the proportion of cardiac functional class I-II increased from @ % ( @/@ ) to @ % ( @/@ ) significantly after treatment ( P < @ ) .


Between two groups , the proportion of mild and moderate turning to server PAH patients were significant difference ( P < @ ) .


( @ ) The pregnancy outcome of two group : the premature birth rate , low birth weight rate and cesarean section rate of @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in sildenafil group were significantly lower than @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in control group ( P < @ ) .


The rate of vaginal delivery , term pregnancy and neonatal weight of @ % ( @/@ ) , @ % ( @/@ ) and ( @ @ @ ) g in sildenafil group were different with @ % ( @/@ ) , @ % ( @/@ ) and ( @ @ @ ) g in control group ( P < @ ) .


( @ ) Hemodynamic parameters : in control group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression were ( @ @ ) % to ( @ @ ) % , ( @ @ ) to ( @ @ ) mmHg ( @ mmHg = @ kPa ) , @ @ to @ @ and ( @ @ ) to ( @ @ ) mmHg before and after treatment , which showed remarkable decreased trends ( P < @ ) .


The other parameter were not significantly different ( P > @ ) .


In sildenafil group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression showed increased trend before and after treatment , which were ( @ @ ) % to ( @ @ ) % , ( @ @ ) to ( @ @ ) mmHg , @ @ to @ @ ( P < @ ) , in the mean time , pulmonary systolic pression showed decreased trend from ( @ @ ) to ( @ @ ) mmHg ( P < @ ) .


The other parameter did not show significant different ( P > @ ) .


Sildenafil treatment can significantly improve the clinical symptoms , cardiac function and hemodynamic parameters.It also could significantly improve pregnancy outcomes , reduce premature delivery , the incidence of low birth weight children , and cesarean section rate .


The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee ( KOA ) is widely evidenced .


The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA .


A blind , randomized controlled trial design was used .


Eighteen women were randomly allocated to two different groups .


Group A was treated with massage therapy and an exercise program , and Group B was treated with the exercise program alone .


The intervention lasted for @ weeks .


Outcomes were assessed using a verbal analogue scale ( VAS ) , the WOMAC index , and the Get-Up and Go test .


Baseline , post-treatment , and @ - and @ - month follow-up data were collected .


Values were considered statistically significant at a p < @ .


The Mann-Whitney U test was applied in order to find out the differences between groups , and to verify the existence of such differences , the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out .


In both groups , significant differences were found in the three variables between the baseline measurement and three months after treatment , with the exception of the WOMAC variable in group B ( p = @ ) No significant differences were found between both groups in the WOMAC index ( p = @ ) and VAS ( p = @ ) variables and the Get-Up and Go test ( p = @ ) .


Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA .


The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects .


To explore the best therapy for infertility caused by polycystic ovary syndrome ( PCOS ) .


One hundred and twenty patients were randomized into three groups , a clomi-phene group ( group A ) , an acupuncture-moxibustion + Chinese medicine group ( group B ) and a clomiphene + acupuncture-moxibustion + Chinese medicine group ( group C ) , @ cases in each one .


In the group A , since the @th day of menstruation , clomiphene was prescribed for oral administration .


In the group B , on the @th day of menstruation , warm needling therapy was applied at Zhongji ( CV @ ) , Guanyuan ( CV @ ) , Guilai ( ST @ ) , etc. .


Additionally , the Chinese herbal medication for tonifying the kidney and activating blood circulation was provided .


In the group C , the therapy as the group B was combined on the basis of the treatment as the group A.


The treatment lasted continuously for @ menstrual cycles .


The endometrial thickness , endometrial type and cervical mucus score on human chorionic gon adotropin ( HCG ) day , and ovulatory cycle rate , clinical pregnancy rate and abortion rate after treatment were observed in the patients of the three groups .


@ ) HCG day cervical mucus score , endometrial thickness and endometrial morphology ( A type rate ) : the results in the group C were better than those in the group A ( all P < @ ) ; the results in the group B were better than those in the group A ( all P < @ ) .


The difference in the endometrial thickness was not significant in comparison between the group C and the group B ( P > @ ) .


The cervical mucus score and endometrial morphology ( A type rate ) in the group C were better than those in the group B ( both P < @ ) .


@ ) The ovulatory cycle rates in the group A and group ( C were higher than that in the group B ( both P < @ ) , the pregnancy rate in the group C was higher than that in the other groups ( both P < @ ) , and the early abortion rate in the group C was lower than that in the group A and group B ( both P < @ ) .


@ ) Follicle diameter from @ mm to @ mm and endometrial thickness : the differences were not significant between the normal pregnancy patients and the early abortion patients ( both P > @ ) .


The endometrial morphology A type rate in the normal pregnancy patients was higher than that in the early abortion patients ( P < @ ) .


The combined therapy of acupuncture , herbal medicine and clomiphene improves the pregnancy rate and reduces early abortion rate by effectively improving HCG day cervical mucus , endometrial thickness and morphology .


The efficacy is apparently superior to the simple medication with clomiphene and the combined application of acupuncture and herbal medicine .


To reduce the seroma formation following mastectomy and axillary dissection , many different techniques and drugs have been investigated .


The aim of this study is to evaluate the effects of oral - glucan on drain fluid and efficacy of daily drainage and drain removal day in mastectomy patients .


One hundred and thirty breast cancer patients of Ankara Oncology Training and Research Hospital were divided into @ groups by consecutive randomization ( n = @ each ) .


- glucan @mg capsules were administered to Group @ twice a day for @days .


Group @ took placebos in the same manner .


Age , menarche age , menopause , parity , history of oral contraceptives , comorbidities , postoperative daily drainage volumes and drain removal days were recorded and compared .


Seroma samples during the first and second day of drainage were taken for analysis of Interleukin-@ ( IL-@ ) and Tumor Necrosis Factor ( TNF - ) .


There was no difference between groups in terms of age , menarche age , menopause period , parity , oral contraceptive use and comorbidities .


Group @ showed significantly lower daily drainage volumes between days @ and @ .


Mean drain removal day was @ in Group @ and @ in Group @ .


The difference was significant ( p < @ ) .


TNF - and IL-@ levels on days @ and @ in Group @ were significantly lower ( p < @ ) .


In addition , - glucan significantly shortened the number of days required for the drain removal in patients who have comorbidities ( p = @ ) .


The earliest removal was in patients without comorbidity and who received - glucan ( p = @ ) .


- glucan decreased drain discharges after mastectomy .


The drains were removed earlier in - glucan administered patients .


Efavirenz and nevirapine failure is associated with a rapid selection of resistance-associated mutations ( RAMs ) , which may impact on etravirine or rilpivirine susceptibility .


However , RAMs for rilpivirine and etravirine can not be reported on previous resistance genotypes because these specific RAMs were not analyzed at that time .


Therefore , our objective was to determine , in virologically suppressed HIV-@-infected individuals , the presence of RAMs to rilpivirine , etravirine and the combination of tenofovir/emtricitabine/rilpivirine in HIV-@ DNA from individuals previously exposed to efavirenz and/or nevirapine .


The studied population included @ treatment-experienced individuals enrolled in the ANRS @-EASIER trial who previously failed on and/or were intolerant to efavirenz and/or nevirapine and who had plasma HIV-@ RNA < @ copies/mL .


Resistance to rilpivirine , etravirine , tenofovir and emtricitabine by bulk sequencing was performed on extracted HIV-@ DNA from whole blood collected at the time of trial inclusion .


Reverse transcriptase gene amplification was successful in @/@ ( @ % ) individuals and @ % of HIV-@ were infected with subtype B. Rilpivirine RAMs were detected in @ ( @ % ) individuals , with highest frequency for the mutations Y@C/I/V ( @ % ) , K@E/P ( @ % ) and E@A/G/K / Q/R/S ( @ % ) and the association L@I + K@N/S ( @ % ) .


Etravirine RAMs were detected in five ( @ % ) individuals .


Resistance to emtricitabine , tenofovir and at least one drug included in the combination of tenofovir/emtricitabine/rilpivirine were detected in @ ( @ % ) , @ ( @ % ) and @ ( @ % ) , respectively .


In individuals with suppressed viraemia under antiretroviral therapy ( ART ) , but who had been previously exposed to an efavirenz and/or nevirapine-based regimen , rilpivirine RAMs are frequent and etravirine RAMs are rare .


This finding suggests that the switch to a rilpivirine-based regimen should not be recommended .


To evaluate the incremental prognostic value of the number and maximum volume of coronary artery calcifications over modified Agatston score strata , age , pack-years , and smoking status for predicting cardiovascular events .


A total of @ male current and former smokers received a CT examination for lung cancer screening .


Smoking characteristics , patient demographics , and physician-diagnosed cardiovascular events were collected .


Images were acquired without electrocardiography gating on @-slice CT scanners .


The association between the presence of both fatal and nonfatal cardiovascular events and the predictors was quantified using Cox proportional hazard analysis .


Median follow-up period was @ years .


Incident cardiovascular events occurred in @ participants .


Adjusted hazard ratios for modified Agatston score strata of @ to @ , @ to @ , @ to @ , and > @ were @ ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , @ ( @ % CI , @-@ @ ) , @ ( @ % CI , @-@ @ ) , and @ ( @ % CI , @-@ @ ) , respectively .


Moreover , comparing the models with and without modified Agatston score strata to the model with age , pack-years , and smoking status yielded a significantly better net reclassification improvement ( NRI ; @ % ; P < @ ) .


Adding the number of calcifications to the model with age , pack-years , smoking status , and modified Agatston score strata resulted in a slightly better NRI ( @ % ; P = @ ) with a hazard ratio of @ ( @ % CI , @-@ @ ) per @ calcifications .


The incremental prognostic information contained in the volume of the largest calcification was not statistically significant ( NRI , @ % ; P = @ ) .


Cardiovascular event rate increased with higher numbers of calcified lesions .


The number but not maximum volume of calcifications has independent , although minimal , prognostic value over age , pack-years , smoking status , and modified Agatston score strata in our population .


The results of the CLOTS @ trial showed that intermittent pneumatic compression ( IPC ) reduced the risk of deep vein thrombosis and improved survival in immobile patients with stroke .


IPC is now being widely used in stroke units .


Here we describe the disability , living circumstances , quality of life , and hospital costs of patients in CLOTS @ .


In CLOTS @ , a parallel group trial in @ UK hospitals , immobile patients with stroke from days @ to @ of admission were assigned with a computer-generated allocation sequence in a @:@ ratio to IPC or no IPC through a central randomisation system .


We followed up patients at about @ months with postal or telephone questionnaire to assess the secondary endpoints : disability ( Oxford Handicap Scale -LSB- OHS -RSB- ) , living circumstances , health-related quality of life ( EQ@D-@L ) , and hospital costs ( based on use of IPC and length of hospital stay ) .


Patients and carers who completed the postal questionnaires were not masked to treatment allocation , but telephone follow-up in non-responders was masked .


All analyses were by intention to treat .


This trial is registered , number ISRCTN@ .


Between Dec @ , @ , and Sept @ , @ , we enrolled @ patients , with @ in each group .


Despite the previously reported reduction in the risk of proximal deep vein thrombosis at @ days ( primary endpoint ) , there were no significant differences in disability ( OHS @-@ vs @-@ , adjusted odds ratio -LSB- OR -RSB- @ , @ % CI @ to @ , p = @ ; adjusted ordinal analysis common OR @ , @ % CI @ to @ ) , living circumstances ( institutional care vs not ; adjusted OR @ , @ % CI @ to @ ; p = @ ) , or health-related quality of life ( median utility value @ , IQR -@ to @ with IPC , and @ , -@ to @ , with no IPC ; p = @ ) .


The estimated cost of IPC was @ per patient ( SD @ ) .


The direct costs of preventing a deep vein thrombosis and death were @ ( @ % CI @ to @ ) and @ ( @ to not estimable ) , respectively , with IPC .


Hospital costs increased by @ with IPC compared with no IPC because of a longer stay in hospital ( mean @ days -LSB- SD @ -RSB- vs @ days -LSB- @ -RSB- ; mean difference @ days , @ % CI -@ to @ ) .


By @ months , despite an increase in survival ( IPC @ days -LSB- SD @ -RSB- vs no IPC @ days -LSB- @ -RSB- ; mean difference @ days , @ % CI -@ to @ ) , there was a non-significant increase in quality-adjusted survival associated with IPC ( IPC @ days -LSB- SD @ -RSB- vs no IPC @ days -LSB- @ -RSB- ; mean difference @ days , @ % CI -@ to @ ) .


IPC is inexpensive , prevents deep vein thrombosis , improves survival but not functional outcomes , and does not lead to a significant gain in quality-adjusted survival .


When deciding whether to treat patients with IPC , clinicians need to take into account all these potential effects .


Psychogenic gait disorder , defined as loss of ability to walk without neurological aetiologies , has poor rehabilitation options that are well documented .


Left untreated these patients have substantial and long-lasting dysfunction .


The present study examined the effect of a @-week inpatient rehabilitation programme compared with a waiting list control condition , and whether eventual gains were maintained at @-month and @-year follow-up .


A cross-over design evaluated the effect of treatment , and a carry-over effect was considered as a long-lasting treatment effect .


Treatment consisted of adapted physical activity within a cognitive behavioural framework , and focused on offering an alternative explanation of symptoms , positively reinforcing normal gait and not reinforcing dysfunction .


A total of @ patients were recruited from neurological departments and were randomly assigned to immediate treatment ( intervention ) or treatment after @ weeks ( controls ) .


Cross-over design revealed that the mean difference between treatment vs no treatment was @ Functional Independence Measure units ( p < @ , @ % confidence interval @-@ @ ) , and @ Functional Mobility Scale units ( p < @ , @ % confidence interval @-@ @ ) .


Patients significantly improved their ability to walk and their quality of life after inpatient rehabilitation compared with the untreated control group .


The improvements in gait were sustained at @-month and @-year follow-up .


Substantial and lasting improvement can be achieved by inpatient rehabilitation of patients with psychogenic gait , and the gains are maintained during follow-up .


Chronic lung allograft dysfunction ( CLAD ) , predominantly manifest as bronchiolitis obliterans syndrome ( BOS ) , is the primary cause of morbidity and death after lung transplantation .


We assessed the efficacy and safety of @ de novo immunosuppression protocols to prevent BOS .


This was a multicenter , prospective , international , randomized ( @:@ ) open-label superiority study of de novo enteric-coated mycophenolate sodium ( MPS ) vs delayed-onset everolimus ( RAD ) , both arms in combination with cyclosporine ( CsA ) monitored by @-hour post-dose ( C@ ) levels , and corticosteroids .


Target C@ levels were lower in the RAD group because RAD is known to potentiate CsA nephrotoxicity .


Cytolytic induction therapy was not used .


Patients were stratified at entry for cystic fibrosis .


Confirmation of anastomotic healing was required for randomization .


Primary efficacy was freedom from BOS Grade @ on intention-to-treat ( ITT ) analysis .


Secondary efficacy parameters were patient and graft survival and severity of rejection .


Treatment failure was defined by graft loss , patient death , drug cessation , or need for other therapy .


The @-year freedom from BOS Grade @ was @ % for MPS ( n = @ ) vs @ % for RAD ( n = @ ; p = @ by log-rank ) in ITT but was lower in the RAD arm of the per-protocol population ( p = @ ) .


The @-year survival was @ % ( MPS ) vs @ % ( RAD ; p = @ by log-rank ) .


Thirteen patients switched from MPS vs @ from RAD ( p < @ ) .


Days on MPS were greater than days on RAD ( p < @ ) .


Rejection events proven by biopsy specimen were more common on MPS ( p = @ ) , as were leucopenia ( p < @ ) , diarrhea ( p < @ ) , and cytomegalovirus infection ( p = @ ) .


Venous thromboembolism was more frequent on RAD ( p = @ ) .


Creatinine at @ years was @ @ mol/@iter in MPS patients vs @ @ mol/@iter in RAD patients ( p = @ ) .


This @-year ITT analysis found no significant difference between arms but was underpowered to accept the null hypothesis that RAD and MPS have equivalent efficacy in preventing BOS or death after lung transplantation .


We tested the hypothesis that sleep training would improve emotional , social and behavioural functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared to children with ADHD without such intervention and to healthy controls .


Forty children with ADHD were randomly assigned to intervention and control conditions .


Parents of @ children with ADHD were instructed and thoroughly supervised in improving their children 's sleep schedules and sleep behaviour .


Parents of the other @ children with ADHD and parents of @ healthy children received general information about sleep hygiene .


At baseline and @ weeks later , parents and children completed questionnaires related to children 's sleep and psychological functioning .


Relative to the control groups , children in the intervention group improved sleep quantitatively and qualitatively ( F values < @ , P values < @ ) .


The intervention group children reported improvements in mood , emotions , and relationships ( F values < @ , P values < @ ) .


Parents reported that their children improved in physical and psychological wellbeing , mood , emotions , relationships , and social acceptance ( F values < @ , P values < @ ) .


Training and monitoring parents of children with ADHD in regulating and supervising children 's sleep schedules leads to positive changes in the emotions , behaviour and social lives of these children .


To compare the impact of scheduling caesarean section prior to versus after @ completed weeks of gestation on the occurrence of unscheduled caesarean section and rescheduling of the procedure .


Secondary analysis from a multicentre randomised open-label trial including singleton pregnant women with a healthy foetus and a reliable due date .


Women were allocated by computerized telephone randomisation to planned caesarean section at @ weeks and three days or @ weeks and three days .


The outcomes were unscheduled deliveries with provided reasons , such as spontaneous labour onset or supervening complications , and any changes in the scheduled delivery date .


Statistical analyses were according to intention-to-treat using Fisher 's exact test .


From March @ to June @ @,@ women were included .


Median difference in gestational age at delivery was six days .


Compared to the @ weeks group , the women in the @ weeks group were more likely to have an unscheduled caesarean section ( @ % vs. @ % ; RR @ , @ % CI @ ; @ ) , to deliver between @ pm and @ am ( @ % vs. @ % ; RR @ , @ % CI @ ; @ ) , or to have the procedure rescheduled ( @ % vs. @ % ; RR @ , @ % CI @ ; @ ) .


Scheduling caesarean section after @ weeks leads to a @ % increase in unscheduled caesarean sections and a @ % increase in delivery outside regular work hours as compared to scheduling of the procedure prior to @ weeks .


We hypothesized that @ days of normal daily activity after @ days of experimental bed rest ( BR ) will not reverse BR induced impaired glucose tolerance .


Glucose tolerance of seven male , healthy , untrained test subjects ( age : @ ( @ ) years ( mean ( SD ) ) ; body mass : @ ( @ ) kg ; height : @ ( @ ) m ; VO@ max : @ ( @ ) ml/kg body mass/min ) was studied .


They stayed twice in the metabolic ward ( crossover design ) , @ days in bed and @ days before and after BR each .


Oral glucose tolerance tests were applied before , on day @ of BR , and @ and @ days after BR .


On day @ of BR , AUC ( @min ) of glucose concentration was increased by @ ( @ ) % and AUC ( @min ) of insulin by @ ( @ ) % ( glucose : P < @ ; insulin : P = @ ) .


Fourteen days after BR , AUC ( @min ) of serum insulin concentrations returned to pre-bed-rest concentrations ( P = @ ) and AUC ( @min ) of glucose was still higher ( P = @ ) .


Insulin resistance did not change , but sensitivity index was reduced during BR ( P = @ ) .


Four days of light physical workload does not compensate inactivity induced impaired glucose tolerance .


An individually tailored and intensified training regime is mandatory in patients being in bed rest to get back to normal glucose metabolism in a reasonable time frame .


The purpose of this study was to investigate whether gentamicin irrigation solutions provide a potential new tool to prevent joint infection after arthroscopic ACL reconstruction .


In this prospective randomized study , @ consecutive ACL recondition patients were randomized in two groups alternately from Feb @ to March @ .


In the first group , @ patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( @ % sodium chloride ) solution .


In the second group @ patients underwent ACL reconstruction with a hamstring autograft , preoperative IV antibiotics , and normal saline ( @ % sodium chloride solution ) with added gentamicin ( @ mg/L ) ( group @ ) .


Three patients from group @ and six patients from group @ were excluded from the study due to loss of follow-up .


The patients were followed for @ months and assessed for signs of deep infection .


In group @ , a total of @ ( @ % ) postoperative septic arthritis cases were documented .


In group @ , just one postoperative deep infection ( septic arthritis ) was documented ( @ % ) .


Although the rate of septic arthritis in group @ was higher than in group @ , statistical analysis showed that the difference between using the gentamicin irrigation solution ( @ mg/L ) and the saline solution alone was not significant .


Using gentamicin in irrigating solutions during arthroscopic ACL reconstruction surgery does not statistically decrease post operation septic arthritis .


Therapeutic Level II .


To evaluate the effect of sitagliptin in combination with metformin on glucose toxicity and lipotoxicity in patients with type @ diabetes mellitus .


Eighty-two overweight and dyslipidemic patients ( mean age @ + / - @ years ) who had not achieved the goal levels of glycated hemoglobin ( HbA@c ) ( mean level @ + / - @ % ) during metformin therapy and dietotherapy were examined .


Group @ patients received sitagliptin @ mg/day in combination with metformin @ g/day ; Group @ took metformin @-@ g/day .


The levels of fasting plasma glucose ( FPG ) levels , postprandial glycemia ( PPG ) , HbA@c , body weight , body mass index , waist circumference , and waist-to-hip ratio , blood lipid composition , and the levels of insulin , leptin , adiponectin , HOMA-IR , and HOMA-beta were estimated at baseline and @ months later .


Visceral fat ( VF ) magnetic resonance imaging ( MRI ) was carried out .


Following @ months , both groups showed positive changes in FPG , PPG , and HbA@c levels .


HbA@c decreased from @ + / - @ to @ + / - @ % in Group @ and from @ + / - @ to @ + / - @ % in Group @ .


PPG and FPG reduced by an average of @ and @ mmol/l in Group @ and by @ and @ mmol/l in Group @ .


HOMA-beta increased by @ .


conventional units ( CU ) in Group @ and by @ CU in Group @ .


HOMA-IR was noted to display positive changes in both groups .


The level of adiponectin rose by @ ng/ml in Group @ and by @ % ng/ml in Group @ and that of leptin fell by @ and @ ng/ml , respectively .


There were significant differences between the groups in anthropometric changes .


MRI revealed a significant VF drop by @ + / - @ cm@ ( @ % ) in Group @ and by @ + / - @ cm@ ( @ % ) in Group @ .


Combined therapy with sitagliptin and metformin caused reductions in glucose toxicity and lipotoxicity .


Genetic counseling for hereditary breast or colon cancer has implications for both counselees and their relatives .


Although counselees are encouraged by genetic counselors to disclose genetic cancer risk information , they do not always share this information with their at-risk relatives .


Reasons for not informing relatives may be generally categorized as a lack of knowledge , motivation and/or self-efficacy .


Presented here is the protocol of a randomized controlled trial that aims to establish the effectiveness of an intervention focused on supporting counselees in their disclosure of genetic cancer information to their relatives .


A multicenter randomized controlled trial with parallel group design will be used to compare the effects of an additional telephone counseling session performed by psychosocial workers to enhance the disclosure of genetic cancer information to at-risk relatives ( intervention group ) with a control group of standard care .


Consecutive index patients with relatives at risk for hereditary or familial breast and/or ovarian cancer or colon cancer , are randomly assigned ( block size : @ ; @:@ allocation ratio ) to the intervention ( n = @ ) or control group ( n = @ , standard care ) .


Primary outcomes are counselees ' knowledge , motivation and self-efficacy regarding informing their relatives .


This intervention may prove important in supporting counselees to disclose hereditary and/or familial cancer risk information to at-risk relatives and may enable more at-risk relatives to make a well-informed decision regarding genetic services and/or screening .


We have previously shown the prognostic importance of tumor-infiltrating lymphocytes ( TILs ) in newly diagnosed triple-negative breast cancer ( TNBC ) using tumor samples from a large clinical trial cohort .


In this study , we aimed to validate these findings and also investigate associations with trastuzumab benefit in HER@-overexpressing disease ( HER@ + ) .


A prospective-retrospective study was conducted using samples from the FinHER adjuvant , phase III trial that enrolled @ early-stage BC patients , @ of whom were HER@-nonamplified .


Those with HER@ + disease ( n = @ ) were randomized to @ weeks of trastuzumab or no trastuzumab in addition to chemotherapy .


Two pathologists independently quantified stromal TILs in @ ( @ % ) available slides .


The primary end point of distant disease-free survival ( DDFS ) and interactions with trastuzumab were studied in Cox regression models .


Confirming our previous findings , in TNBC ( n = @ ) each @ % increase in TILs was significantly associated with decreased distant recurrence in TNBC ; for DDFS the hazard ratio adjusted for clinicopathological factors : @ ; @ % confidence interval ( CI ) @-@ @ , P = @ .


In HER@ + BC ( n = @ ) , each @ % increase in lymphocytic infiltration was significantly associated with decreased distant recurrence in patients randomized to the trastuzumab arm ( DDFS P interaction = @ ) .


Higher levels of TILs present at diagnosis were significantly associated with decreased distant recurrence rates in primary TNBC .


These results confirm our previous data and further support that TILs should be considered as a robust prognostic factor in this BC subtype .


We also report for the first time an association between higher levels of TILs and increased trastuzumab benefit in HER@ + disease .


Further research into why some TN and HER@ + BCs can or can not generate a host antitumor immune response and how trastuzumab can favorably alter the immune microenvironment is warranted .


We aimed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstracts of randomized controlled trials ( RCTs ) in the field of cancer .


We performed a two-arm , parallel-group RCT .


We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion .


Two versions of these abstracts were used-the original with spin and a rewritten version without spin .


Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and reviewers of French national grants .


The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( @ to @ scale ) .


Participants were blinded to study hypothesis .


Three hundred clinicians were randomly assigned using a Web-based system ; @ clinicians assessed an abstract with spin and @ assessed an abstract without spin .


For abstracts with spin , the experimental treatment was rated as being more beneficial ( mean difference , @ ; @ % CI , @ to @ ; P = @ ) , the trial was rated as being less rigorous ( mean difference , -@ ; @ % CI , -@ to @ ; P = @ ) , and clinicians were more interested in reading the full-text article ( mean difference , @ ; @ % CI , @ to @ ; P = @ ) .


There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial .


Spin in abstracts can have an impact on clinicians ' interpretation of the trial results .


Globally , herpes simplex virus type @ ( HSV-@ ) infection is the most common cause of genital ulcer disease .


Effective prevention strategies for HSV-@ infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections .


We assessed the effectiveness of pericoital tenofovir gel , an antiviral microbicide , in preventing HSV-@ acquisition in a subgroup of @ HSV-@-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa ( CAPRISA ) @ study , a double-blind , randomized , placebo-controlled trial .


Incident HSV-@ cases were identified by evidence of seroconversion on an HSV-@ IgG enzyme-linked immunosorbent assay between study enrollment and exit .


A confirmatory analysis was performed by Western blot testing .


The HSV-@ incidence rate was @ cases per @ person-years ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) among @ women assigned to tenofovir gel , as compared with @ cases per @ person-years ( @ % CI , @ to @ ) among @ women assigned to placebo gel ( incidence rate ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The HSV-@ incidence rate among the @ women with vaginal tenofovir concentrations of @,@ ng per milliliter or more was @ cases per @ person-years , as compared with @ cases per @ person-years among the @ women with no detectable vaginal tenofovir ( incidence rate ratio , @ ; @ % CI , @ to @ ; P = @ ) .


As confirmed by Western blot testing , there were @ HSV-@ seroconversions among women assigned to tenofovir gel as compared with @ among those assigned to the placebo gel ( incidence rate ratio , @ ; @ % CI , @ to @ ; P = @ ) .


In this study in South Africa , pericoital application of tenofovir gel reduced HSV-@ acquisition in women .


( Funded by the U.S. Agency for International Development and others ; ClinicalTrials.gov number , NCT@ . )


The implementation of a complex intervention is heavily influenced by individual context .


Variation in implementation and tailoring of the intervention to the particular context will occur , even in a trial setting .


It is recognised that in trials , evaluating the process of implementation of a complex intervention is important , yet process evaluation methods are rarely reported .


The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged @-@ years , delivered by teachers in primary schools across the West Midlands , UK .


The intervention promoted activities encouraging physical activity and healthy eating .


This paper presents the methods used to assess implementation of the intervention .


Previous literature was used to identify the dimensions of intervention process and implementation to be assessed , including adherence , exposure , quality of delivery , participant responsiveness , context , and programme differentiation .


Multiple methods and tools were developed to capture information on all these dimensions .


These included observations , logbooks , qualitative evaluation , questionnaires and research team reflection .


Data collection posed several challenges , predominantly when relying on teachers to complete paperwork , which they saw as burdensome on top of their teaching responsibilities .


However , the use of multiple methods helped to ensure data on each dimension , where possible , was collected using more than one method .


This also allowed for triangulation of the findings when several data sources on any one dimension were available .


We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial .


These approaches can be transferred and adapted for use in other complex intervention trials .


Low-cost interventions to improve cancer screening among primary care patients are needed .


The comparative effectiveness of personalized letters , automated telephone calls , and both on breast cancer ( BC ) and colorectal cancer ( CRC ) screening is not known .


A pragmatic , randomized , controlled trial was conducted in @ to @ .


Eligible primary care patients were women ages @ to @ years who were past due for mammography and men or women who were past due for mammography or CRC screening of any kind ( > @ months since last fecal occult blood test , > @ years since last sigmoidoscopy/double-contrast barium enema , or > @ years since last colonoscopy ) , respectively .


Participants were randomized to @ of @ interventions : personalized mailed letters , automated telephone calls , or both .


The primary outcome was medical record documentation of a completed mammogram or CRC screening within @ weeks of randomization .


We estimated the costs of each intervention and calculated the marginal cost-effectiveness per person screened .


The crude screening rates for BC were @ % , @ % , and @ % and for CRC were @ % , @ % , and @ % for the letter , automated call , and combined ( letter/automated call ) groups , respectively .


The combined intervention group had a statistically higher screening rate ( P < @ ) compared with either of the single intervention groups ( letter only or automated call ) for both BC and CRC in both the crude and adjusted analyses .


The combined intervention costs $ @ per additional person screened for BC and $ @ per additional person screened for CRC .


In a primary care practice , letters plus automated telephone calls are better than either alone in increasing cancer screening rates among patients who are overdue for screening .


These findings suggest the promise of a relatively inexpensive intervention to improve cancer screening .


Graphic warnings ( GWs ) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood .


This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables ( e.g. , psychological reactance ) .


One hypothesis predicted adaptive responding ( GWs would lower smoking-related intentions ) and another predicted defensive responding ( GWs would raise smoking-related intentions ) .


Participants were an online sample of @,@ Americans ages @-@ , who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control .


Both the intention to smoke in the future and the intention to quit smoking ( among smokers ) were assessed before and after message exposure .


GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history ( between @ and @ cigarettes ) , and they increased intention to quit smoking among those with a heavy lifetime smoking history ( more than @ cigarettes ) .


Both effects were limited to individuals who had smoked in some but not all of the prior @ days ( i.e. , occasional smokers ) .


No evidence of defensive `` boomerang effects '' on intention was observed in any subgroup .


Graphic warnings can reduce interest in smoking among occasional smokers , a finding that supports the adaptive-change hypothesis .


GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults .


Little is known about diet quality with a reduced-energy , low-fat , partial meal replacement plan , especially in individuals with type @ diabetes .


The Action for Health in Diabetes ( Look AHEAD ) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention .


To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at @ months .


A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at @ and @ months .


From @ US sites , the first @ % of participants ( aged @ to @ years , overweight or obese , with type @ diabetes ) were invited to complete dietary assessments .


Complete @ - and @-month dietary assessments ( collected between @ and @ ) were available for @,@ participants ( @ % of total participants ) , with @,@ randomized to Diabetes Support and Education group and @,@ randomized to Intensive Lifestyle Intervention group .


A food frequency questionnaire assessed intake : energy ; percent energy from protein , fat , carbohydrate , polyunsaturated fatty acids , and saturated fats ; trans-fatty acids ; cholesterol ; fiber ; weekly meal replacements ; and daily servings from food groups from the Food Guide Pyramid .


Mixed-factor analyses of covariance , using Proc MIXED with a repeated statement , with age , sex , race/ethnicity , education , and income controlled .


Unadjusted tests compared percent meeting fat-related and food group recommendations at @ months .


At @ months , Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants .


Intensive Lifestyle Intervention participants consumed more servings per day of fruits ; vegetables ; and milk , yogurt , and cheese ; and fewer servings per day of fats , oils , and sweets than Diabetes Support and Education participants .


A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations .


Within Intensive Lifestyle Intervention , a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations .


The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality .


Apolioprotein E ( APOE ) genotype is reported to influence a person 's fasting lipid profile and potentially the response to dietary fat manipulation .


The impact of APOE genotype on the responsiveness to meals of varying fat composition is unknown .


We examined the effect of meals containing @ g of fat rich in saturated fatty acids ( SFAs ) , unsaturated fatty acids ( UNSATs ) , or SFAs with fish oil ( SFA-FO ) on postprandial lipemia .


A randomized , controlled , test meal study was performed in men recruited according to the APOE genotype ( n = @ APOE@/@ , n = @ APOE@/E@ ) .


For the serum apoE response ( meal genotype interaction P = @ ) , concentrations were on average @ % lower after the UNSAT than the SFA-FO meal in APOE@ carriers ( P = @ ) only .


In the genotype groups combined , there was a delay in the time to reach maximum triacylglycerol ( TG ) concentration ( mean SEM : @ @ vs. @ @ min ) and higher maximum nonesterified fatty acid ( @ @ vs. @ @ mmol/L ) and glucose ( @ @ vs. @ @ mmol/L ) concentrations after the SFA than the UNSAT meal , respectively ( P @ ) .


In the Svedberg flotation rate @-@ TG-rich lipoprotein fraction , meal genotype interactions were observed for incremental area under the curve ( IAUC ) for the TG ( P = @ ) and apoE ( P = @ ) responses with a @ % lower apoE IAUC after the UNSAT than the SFA meal ( P = @ ) in the E@ carriers .


Our data indicate that APOE genotype had a modest impact on the postprandial response to meals of varying fat composition in normolipidemic men .


The physiologic importance of greater apoE concentrations after the SFA-rich meals in APOE@ carriers may reflect an impact on TG-rich lipoprotein clearance from the circulation .


This trial was registered at clinicaltrials.gov as NCT@ .


In obese women , @ ) to assess whether lower gestational weight gain ( GWG ) during pregnancy in the lifestyle intervention group of a randomized controlled trial ( RCT ) resulted in differences in offspring anthropometrics and body composition , and @ ) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index ( BMI ) .


The LiPO ( Lifestyle in Pregnancy and Offspring ) study was an offspring follow-up of a RCT with @ obese pregnant women with a lifestyle intervention during pregnancy including dietary advice , coaching and exercise .


The trial was completed by @ women who were eligible for follow-up .


In addition , to the children from the RCT , a group of children born to women with a normal BMI were included as a reference group .


At @ ( range @-@ @ ) years , anthropometrics were measured in @ children of the RCT mothers and in @ reference group children with Body Mass Index ( BMI ) Z-score as a primary outcome .


Body composition was estimated by Dual Energy X-ray ( DEXA ) in @ successful scans out of @ ( @ % ) .


No differences between randomized groups were seen in mean ( @ % C.I. ) BMI Z-score ( intervention group @ -LSB- -@ ; @ -RSB- vs. controls -@ -LSB- -@ ; @ -RSB- ) , in the percentage of overweight or obese children ( @ % vs. @ % ) , in other anthropometrics , or in body composition values by DEXA .


Outcomes between children from the RCT and the reference group children were not significantly different .


The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at @ years of age .


This may reflect the limited difference in GWG between intervention and control groups .


Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI .


In the past @ years , individual patient involvement at the clinical consultation level has received considerable attention .


More recently , patients and the public have increasingly been involved in collective decisions concerning the improvement of health care and policymaking .


However , rigorous evaluation guiding the development and implementation of effective public involvement interventions is lacking .


This article describes those key ingredients likely to affect public members ' ability to deliberate productively with professionals and influence collective health care choices .


We conducted a trial process evaluation of public involvement in setting priorities for health care improvement .


In all , @ participants ( including @ patients and public members and @ professionals ) from @ Health and Social Services Centers in Canada participated in the trial .


We video-recorded @ one-day meetings , and @ nonparticipant observers took structured notes .


Using qualitative analysis , we show how public members influenced health care improvement priorities .


Legitimacy , credibility , and power explain the variations in the public members ' influence .


Their credibility was supported by their personal experience as patients and caregivers , the provision of a structured preparation meeting , and access to population-based data from their community .


Legitimacy was fostered by the recruitment of a balanced group of participants and by the public members ' opportunities to draw from one another 's experience .


The combination of small-group deliberations , wider public consultation , and a moderation style focused on effective group process helped level out the power differences between professionals and the public .


The engagement of key stakeholders in the intervention design and implementation helped build policy support for public involvement .


A number of interacting active ingredients structure and foster the public 's legitimacy , credibility , and power .


By paying greater attention to them , policymakers could develop and implement more effective public involvement interventions .


Observational studies show that when a depressed mother 's symptoms remit , her children 's psychiatric symptoms decrease .


Using randomized treatment assignment , the authors sought to determine the differential effects of a depressed mother 's treatment on her child .


The study was a randomized double-blind @-week trial of escitalopram , bupropion , or the combination of the two in depressed mothers ( N = @ ) , with independent assessment of their children ( N = @ ; ages @-@ years ) .


There were no significant treatment differences in mothers ' depressive symptoms or remission .


Children 's depressive symptoms and functioning improved significantly among those whose mothers were in the escitalopram group ( compared with those whose mothers were in the bupropion and combination treatment groups ) .


Only in the escitalopram group was significant improvement of mother 's depression associated with improvement in the child 's symptoms .


Exploratory analyses suggested that this may be due to changes in parental functioning : Mothers in the escitalopram group reported significantly greater improvement , compared with the other groups , in their ability to listen and talk to their children , who as a group reported that their mothers were more caring over the @ weeks .


Maternal baseline negative affectivity appeared to moderate the effect of maternal treatment on children , although the effect was not statistically significant .


Children of mothers with low negative affectivity improved in all treatment groups .


Children of mothers with high negative affectivity improved significantly only for those whose mothers were in the escitalopram group .


The effects of the depressed mother 's improvement on her children may depend on her type of treatment .


Depressed mothers with high anxious distress and irritability may require medications that reduce these symptoms in order to show the effect of her remission on her children .


To systematically test the cumulative effect of the M Technique on infant neurodevelopment in hospitalized very preterm infants .


A pilot randomized controlled trial ( RCT ) .


Twenty very preterm infants ( < @ weeks gestation with average birth weights < @ g ) were randomly assigned to nontreatment or treatment groups .


The study period began once the infants reached @ weeks postmenstrual age ( PMA ) .


Each infant received standard neonatal intensive unit ( NICU ) care or standard NICU care plus a @-minute M Technique session , @ times per week for @ weeks .


Neurobehavioral development ( using the NICU Network Neurobehavioral Scale -LSB- NNNS -RSB- ) and growth velocity ( difference in infant weight at the beginning and end of protocol ) were compared between the @ groups .


Physiologic parameters ( heart rate , respiratory rate , and oxygen saturations ) and infant behavioral states were measured @ minutes before , during , and up to @ minutes postintervention continuously on all infants in the treatment group at @ different gestational time points ( @ , @ , and @ weeks PMA ) over the @-week period .


Mann-Whitney U analyses revealed no differences between the @ groups on all @ NNNS summary score domains but a difference in growth velocity between the @ groups ( P = @ ) .


Repeated-measures analysis of variance revealed significant physiologic differences of mean heart rate , respiratory rate , and SaO@ ( F = @ , P < @ ) and behavioral states ( F = @ , P < @ ) from baseline to @ minutes after the M Technique intervention across all @ time points .


State scores decreased from baseline ( M = @ ) to post intervention ( M = @ ) at all @ time points .


This pilot RCT demonstrates the utility of the M Technique in hospitalized very preterm infants starting at @ weeks PMA with notable evidence of positive weight , physiological , and behavioral state adaptations .


Additional research is needed with a larger , randomized design to determine short - and long-term effects specifically related to neurological outcomes .


Two phase I , single-blind ( subject blinded to treatment ) , randomized studies were conducted to assess the pharmacodynamics , pharmacokinetics , safety , and tolerability of lipegfilgrastim compared with pegfilgrastim in healthy adult volunteers .


Study @ consisted of a pilot safety phase ( N = @ ) during which subjects received a single body-weight-adjusted subcutaneous dose of lipegfilgrastim @ g/kg and a dose escalation phase ( N = @ ) wherein subjects received lipegfilgrastim @ or @ g/kg or pegfilgrastim @ g/kg .


Study @ was a single-blind , fixed-dose study ( N = @ ) comparing subcutaneous lipegfilgrastim @ mg and pegfilgrastim @ mg .


Cumulative exposure ( AUC@-t last and AUC @ - ) and peak exposure ( Cmax ) were higher for lipegfilgrastim than pegfilgrastim after both weight-adjusted and fixed dosing .


In both studies , the terminal elimination half-life of lipegfilgrastim was @-@ hours longer than the terminal elimination half-life for pegfilgrastim at the maximum dose , and the time to maximum serum concentration ( tmax ) was observed later for lipegfilgrastim than for pegfilgrastim .


The area over the baseline effect curve ( AOBEC ) for absolute neutrophil count ( ANC ) was approximately @ % greater after lipegfilgrastim dosing compared with the same dose of pegfilgrastim at the maximum dose .


Both drugs were well tolerated , with a similar occurrence of adverse events between treatment groups .


Key limitations of these studies include the small numbers of subjects and differences in dosage regimens between the two studies .


In these studies , lipegfilgrastim provided a longer-lasting increase in ANC compared with pegfilgrastim at an equivalent dose , without increasing the peak ANC values .


This may reflect the higher cumulative exposure and slower clearance ( therefore longer body residence ) of lipegfilgrastim .


These data support the use of single-dose lipegfilgrastim @ mg in subsequent phase III trials as prophylactic treatment for patients receiving myelosuppressive chemotherapy .


To determine whether changes in theory of planned behaviour ( TPB ) constructs could predict intention and gluten-free diet ( GFD ) adherence following participation in an online theory-based intervention designed to improve adherence in coeliac disease .


Theory-based process evaluation of the mechanisms of change over the course of a six-week online intervention .


Measures of GFD adherence and TPB variables were administered at baseline and follow-up ( immediate post-intervention : n = @ ; three-month : n = @ ; six-month : n = @ ) .


Hierarchical regression analyses using residualised change scores were conducted at each time point ( dependent variables : intention and adherence ) .


Baseline intention and GFD adherence were the strongest predictors of follow-up intention and adherence , respectively .


Change in attitude accounted for significant variance in intention .


Change in intention accounted for significant variance in GFD adherence immediately post-intervention ; by the six-month follow-up change in perceived behavioural control was the stronger predictor .


Partial support for the hypotheses suggests that , for certain behaviours , the TPB may be relevant in explaining the mechanism of action responsible for changes in intention and behaviour following participation in a behaviour change intervention .


Additional predictive pathways are also likely to exist and , in the area of GFD adherence , may include habit strength and actual behavioural control .


Cooling the pharynx and upper oesophagus would be more advantageous for rapid induction of therapeutic hypothermia since the carotid arteries run in their vicinity .


The aim of this study was to determine the effects of pharyngeal cooling on brain temperature and the safety and feasibility for patients under resuscitation .


Witnessed non-traumatic cardiac arrest patients ( n = @ ) were randomized to receive standard care with ( n = @ ) or without pharyngeal cooling ( n = @ ) .


In the emergency room , pharyngeal cooling was initiated before or shortly after return of spontaneous circulation by perfusing physiological saline ( @ C ) into a pharyngeal cuff for @ min .


There was a significant decrease in tympanic temperature at @ min after arrival ( P = @ ) with a maximum difference between the groups at @ min ( @ @ C , pharyngeal cooling group vs. @ @ C , control group ; P < @ ) .


The return of spontaneous circulation ( @ % vs. @ % , P = @ ) and rearrest ( @ % vs. @ % , P = @ ) rates were not significantly different based on the initiation of pharyngeal cooling .


No post-treatment mechanical or cold-related injury was observed on the pharyngeal epithelium by macroscopic observation .


The thrombocytopaenia incidence was lower in the pharyngeal cooling group ( P = @ ) during the @-day period after arrival .


The cumulative survival rate at @ month was not significantly different between the two groups .


Initiation of pharyngeal cooling before or immediately after the return of spontaneous circulation is safe and feasible .


Pharyngeal cooling can rapidly decrease tympanic temperature without adverse effects on circulation or the pharyngeal epithelium .


Tracheal intubation is one of the strongest stimuli during general anaesthesia and may result in an insufficient depth of anaesthesia .


The aim of the study was to compare the clinical evaluation of the depth of anaesthesia with an evaluation using entropy during inhalational and intravenous induction of general anaesthesia .


This study involved @ patients undergoing elective surgery under general anaesthesia .


Patients were divided into two groups , group E ( etomidate induction ) and group S ( sevoflurane induction ) .


The systolic arterial pressure ( SAP ) , heart rate ( HR ) , response entropy ( RE ) , and state entropy ( SE ) were determined at the following seven measurement points : before anaesthesia induction , at the loss of consciousness ( LOC ) point , before tracheal intubation , immediately after intubation , and @ min. , @ min .


and @ min .


after tracheal intubation .


An increase in HR and/or SAP of more than @ % and/or the occurrence of lacrimation and/or perspiration in response to tracheal intubation was considered a marker of inadequate anaesthesia in the clinical evaluation .


The depth of anaesthesia was considered insufficient according to entropy monitoring if the RE and SE were above @ .


In clinical evaluation , insufficient anaesthesia in response to tracheal intubation was observed in all the patients in group E and in more than half of the patients in group S.


At the same time , the majority of patients in both groups had entropy values that did not exceed the recommended value as an appropriate level of anaesthesia .


We found a discrepancy in the evaluation of the depth of anaesthesia based on clinical criteria compared with evaluations based on entropy values during both intravenous and inhalational induction of general anaesthesia .


Current treatment of ischaemic stroke with thrombolytic therapy is restricted to @-@ h after symptom onset .


We aimed to assess the safety and efficacy of desmoteplase , a fibrin-dependent plasminogen activator , given between @ h and @ h after symptom onset in patients with occlusion or high-grade stenosis in major cerebral arteries .


In a prospective , double-blind , multicentre , parallel-group , randomised trial , we enrolled patients from @ hospitals in @ countries who had ischaemic stroke and occlusion or high-grade stenosis in major cerebral arteries .


We randomly assigned patients in a @:@ ratio , using computer-generated randomisation lists with stratification for baseline National Institutes of Health Stroke Scale and age , to treatment with desmoteplase ( @ g/kg ) given @-@ h after symptom onset or to placebo .


Patients , investigators , staff , and the funder were masked to treatment assignment .


The primary outcome was a favourable modified Rankin Scale score ( @-@ ) at day @ in all treated patients who had at least one postbaseline measurement of the modified Rankin Scale .


Safety was assessed in all randomly assigned patients who received study drugs .


This trial is registered with ClinicalTrials.gov , number NCT@ .


Between Feb @ , @ , and Nov @ , @ , we enrolled @ patients and randomly assigned @ to desmoteplase and @ to placebo ( @ in the desmoteplase group and @ in the placebo group were included in the analysis of the primary endpoint ) .


Median time from stroke onset to treatment was @ h ( IQR @-@ ) for placebo and @ h ( @-@ ) for desmoteplase .


Modified Rankin Scale score ( @-@ ) at day @ occurred in @ ( @ % ) patients given desmoteplase and @ ( @ % ) patients given placebo ( adjusted odds ratio @ , @ % CI @-@ , p = @ ) .


@ ( @ % ) of @ patients given desmoteplase died compared with @ ( @ % ) of @ patients given placebo .


Serious adverse events occurred in @ ( @ % ) of @ patients receiving desmoteplase compared with @ ( @ % ) of @ patients receiving placebo ; frequency of symptomatic intracranial haemorrhage ( six -LSB- @ % -RSB- patients in the desmoteplase group vs five -LSB- @ % -RSB- in the placebo group ) , symptomatic cerebral oedema ( five -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ) , and major haemorrhage ( ten -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) was much the same between treatment groups .


Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond @ h of symptom onset .


Beneficial effects of dietary supplements in age-related macular degeneration ( AMD ) are related to antioxidative properties .


In the Age-Related Eye Disease Study @ ( AREDS @ ) , a reduced progression to late stage AMD was found using vitamin C , E , zinc , and - carotene .


We showed previously that the AREDS @ formulation restores the O@-induced retinal vasoconstrictor response of retinal vessels in a human endotoxin ( lipopolysaccharide -LSB- LPS -RSB- ) model .


We hypothesized that the abnormal O@-induced retinal red blood cell ( RBC ) flow response can be modulated by a different formulation ( vitamin C , E , and zinc , lutein/zeaxanthin , selenium , taurine , Aronia extract , and omega-@ free fatty acids ) .


A total of @ healthy subjects was included in this randomized , double masked , placebo-controlled parallel group study .


The reactivity of retinal arterial and venous diameter , RBC velocity , and flow to @ % O@ breathing was investigated in the absence and presence of @ ng/kg LPS .


Between the two study days was a @-day period of daily dietary supplement intake .


The decrease in retinal arterial diameter , RBC velocity , and flow during @ % O@ breathing was diminished significantly after LPS infusion .


Dietary supplement intake for @ days almost restored the response of retinal hemodynamic parameters to @ % O@ after LPS administration .


This effect was significant for retinal arterial diameter ( P = @ between groups ) , and RBC velocity and flow ( each P < @ between groups ) .


The present data indicate restoring of the RBC flow response to @ % O@ after LPS administration .


This is likely due to an amelioration of endothelial dysfunction resulting from oxidative stress , a factor involved in AMD pathophysiology .


( ClinicalTrials.gov number , NCT@ . )


To compare the performance and effectiveness of a hydrocolloid dressing ( HD ) and a transparent polyurethane film ( PF ) in preventing pressure ulcer ( PU ) development .


The study was conducted in the intensive care unit , coronary care unit and medical clinic of the Holy House of Mercy of Passos , Brazil .


Data were collected @ hours after admission and during hospitalisation .


The Braden scale was used for PU risk assessment .


Consecutive eligible patients without PUs were randomly assigned by lottery to the two groups , either the HD or PF group .


Of the @ eligible patients , significant between-group differences were found in the mean total number of dressing changes ( HD , @ changes ; PF , @ changes ; p = @ ) , and mean number of dressing changes in the sacral region ( HD , @ ; PF , @ ; p = @ ) , with the PF group requiring significantly fewer changes than the HD group .


The most common reasons for changing dressings in both groups were moisture ( PF @ % ; HD @ % ) and shear ( HD @ % ; PF @ % ) , with a significant difference in shear between groups .


The incidence of PUs was significantly lower ( p = @ ) in the PF group ( @ % ) compared with that in the HD group ( @ % ) .


The results suggest that the transparent polyurethane film had a better performance and was more effective than the hydrocolloid dressing in preventing PU development .


To evaluate Bacille Calmette-Gurin ( BCG ) effects after clinically isolated syndromes ( CIS ) .


In a double-blind , placebo-controlled trial , participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI ( @ scans ) .


Both groups then entered a preplanned phase with IM interferon -- @a for @ months .


From month @ onward , the patients took the disease-modifying therapies ( DMTs ) that their neurologist considered indicated in an open-label extension phase lasting up to @ months .


Of @ randomized subjects , @ completed the study ( @ vaccinated and @ placebo ) .


During the initial @ months , the number of cumulative lesions was significantly lower in vaccinated people .


The relative risks were @ ( @ % confidence interval -LSB- CI -RSB- @-@ @ ; p = @ ) for gadolinium-enhancing lesions ( the primary endpoint ) , @ ( @ % CI @-@ @ ; p = @ ) for new and enlarging T@-hyperintense lesions , and @ ( @ % CI @-@ @ ; p = @ ) for new T@-hypointense lesions .


The number of total T@-hypointense lesions was lower in the BCG group at months @ , @ , and @ : mean changes from baseline were -@ @ vs @ @ ( p = @ ) , @ @ vs @ @ ( p = @ ) , and -@ @ vs @ @ ( p = @ ) .


After @ months , the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm ( hazard ratio = @ , @ % CI @-@ @ ; p < @ ) , and more vaccinated people remained DMT-free ( odds ratio = @ , @ % CI @-@ @ ; p = @ ) .


Early BCG may benefit CIS and affect its long-term course .


BCG , as compared to placebo , was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a @-month period before starting immunomodulating therapy ( Class I evidence ) .


To systematically investigate chemotherapy versus chemotherapy followed by involved field radiotherapy for limited-stage aggressive non-Hodgkin 's lymphoma .


A systematic literature search of Pubmed , EMBASE , and the Cochrane central register of controlled trials was performed .


Data from all randomized controlled trials comparing chemotherapy alone with chemotherapy followed by involved field radiotherapy in patients with limited-stage aggressive non-Hodgkin 's lymphoma was collaborate .


The primary outcome was overall survival ; secondary outcomes were event-free survival and cumulative incidences of toxicity .


Three randomized controlled trials , with @ participants in total , were analyzed .


Median follow-up was @ years .