Three groups were compared : those with early disease ( < @year ) , patients with a baseline disease of @-@ years , and those with long-standing onychomycosis ( > @years ) .


The majority of patients had long-standing disease ; were older , male and white .


While nail involvement of the target toenail did not differ noticeably amongst the three groups , the number of nails involved did increase progressively with disease duration .


Differences were seen in terms of infecting pathogens in early disease that might have important treatment implications .


Efinaconazole was more effective in treating early disease , however more than @ % of patients with long-standing disease were considered treatment successes .


A period of @ weeks may be too brief to evaluate a clinical cure in onychomycosis .


Treatment of onychomycosis early to avoid disease progression to other toenails is important .


Once daily efinaconazole topical solution , @ % is particularly effective in these patients .


Statins modify correlations between apolipoprotein B ( apoB ) and low-density lipoprotein cholesterol ( LDL-C ) and apoB and non-high-density lipoprotein cholesterol ( non-HDL-C ) ; however , it is not known whether niacin-based therapies have similar effects .


To evaluate the effects of extended-release niacin ( ERN ) / laropiprant ( LRPT ) , simvastatin ( SIMVA ) , and ERN/LRPT + SIMVA ( pooled ERN/LRPT + SIMVA ) on apoB : LDL-C and apoB : non-HDL-C correlations in dyslipidemic patients .


This post-hoc analysis of a @-week study evaluated the apoB : LDL-C and apoB : non-HDL-C correlations in dyslipidemic patients randomized equally to double-blind ERN/LRPT @ g/@ mg , SIMVA @ , @ , or @ mg , or ERN/LRPT @ g/@ mg + SIMVA ( @ , @ , or @ mg ) once daily for @ weeks .


At week @ , doses were doubled in all groups except SIMVA @ mg ( unchanged ) and ERN/LRPT @ g/@ mg + SIMVA @ mg ( switched to ERN/LRPT @ g/@ mg + SIMVA @ mg ) .


Simple linear regression analyses were used to calculate LDL-C and non-HDL-C levels corresponding to known apoB baseline values ( ie , in untreated patients ) and following treatment .


The apoB : LDL-C and apoB : non-HDL-C correlations were higher and the predicted LDL-C and non-HDL-C levels for a known apoB value were considerably lower following treatment with ERN/LRPT , SIMVA and ERN/LRPT + SIMVA compared with untreated patients at baseline .


Greater dissociation of apoB , LDL-C , and non-HDL-C targets occur following treatment with ERN/LRPT , SIMVA , and ERN/LRPT + SIMVA in patients with dyslipidemia .


The achievement of more aggressive LDL-C and non-HDL-C goals in patients receiving lipid-modifying therapy may further reduce coronary risk by normalizing apoB-containing atherogenic lipoproteins .


Dietary supplements have been proposed as a mechanism to improve health and prevent disease .


To determine if supplementing diet with long-chain -@ polyunsaturated fatty acids or with macular xanthophylls results in a reduced rate of cardiovascular disease ( CVD ) .


The Cardiovascular Outcome Study ( COS ) was an ancillary study of the Age-Related Eye Disease Study @ ( AREDS@ ) , a factorial-designed randomized clinical trial of @ participants recruited from @ US academic and community ophthalmology clinics , who were followed up for a median of @ years .


Individuals were eligible to participate if they were between the ages of @ and @ years , had intermediate or advanced age-related macular degeneration in @ eye , and were willing to be randomized .


Participants with stable , existing CVD ( > @ months since initial event ) were eligible to participate .


Participants , staff , and outcome assessors were masked to intervention .


Daily supplementation with long-chain -@ polyunsaturated fatty acids ( @-mg docosahexaenoic acid -LSB- DHA -RSB- + @-mg eicosapentaenoic acid -LSB- EPA -RSB- ) , macular xanthophylls ( @-mg lutein + @-mg zeaxanthin ) , combination of the two , or matching placebos .


These treatments were added to background therapy of the AREDS vitamin and mineral formulation for macular degeneration .


MAIN OUTCOMES AND MEASURES A composite outcome of myocardial infarction , stroke , and cardiovascular death with @ prespecified secondary combinations of the primary outcome with hospitalized heart failure , revascularization , or unstable angina .


Study participants were primarily white , married , and highly educated , with a median age at baseline of @ years .


A total of @ cardiovascular events were adjudicated , and @ were found to meet @ of the study definitions for a CVD outcome .


In intention-to-treat analysis , no reduction in the risk of CVD or secondary CVD outcomes was seen for the DHA+EPA ( primary outcome : hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ) or lutein + zeaxanthin ( primary outcome : HR , @ ; @ % CI , @-@ @ ) groups .


No differences in adverse events or serious adverse event were seen by treatment group .


The sample size was sufficient to detect a @ % reduction in CVD events with @ % power .


Dietary supplementation of long-chain -@ polyunsaturated fatty acids or macular xanthophylls in addition to daily intake of minerals and vitamins did not reduce the risk of CVD in elderly participants with age-related macular degeneration .


To compare the outcomes of phacoemulsification with toric intraocular lens implantation vs phacoemulsification with monofocal intraocular lens implantation followed by photorefractive keratectomy ( PRK ) for correction of pre-existing astigmatism .


Randomized controlled trial , @-month study .


setting : Institutional .


Sixty eyes of @ patients with age-related senile cataract and regular corneal astigmatism ranging from @ to @ diopters , enrolled and randomly allocated in @ groups based on computer-generated random number table .


Group @ patients underwent phacoemulsification with toric intraocular lens ( IOL ) implantation and Group @ patients underwent phacoemulsification with monofocal IOL implantation followed by PRK @months later .


The main outcome measures were uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , residual cylinder , contrast sensitivity , glare acuity , pain score , and higher-order aberrations .


At @months @ % of eyes in the toric IOL and @ % eyes in the monofocal IOL with PRK group attained UDVA of @/@ .


Median residual refractive cylinder value was higher in the toric IOL group ( toric IOL = -@ , monofocal IOL with PRK = @ ; P = @ ) .


Mean root mean square value of total aberrations ( @mm pupil ) was higher in monofocal IOL with PRK eyes ( toric IOL = @ @ , monofocal IOL with PRK = @ @ ; P = @ ) .


Mean contrast sensitivity values were comparable .


Mean toric IOL rotation was @ @ degrees .


Mean glare acuity was better in toric IOL eyes ( toric IOL = @ @ , monofocal IOL with PRK = @ @ ; P < @ ) .


Median postoperative pain scores were higher in monofocal IOL with PRK eyes .


PRK yields lesser residual cylinder compared to toric IOL .


However , it causes greater postoperative pain and corneal aberrations , and poor glare acuity .


Diclofenac is used for the treatment of osteoarthritis ( OA ) ; however , like other nonsteroidal anti-inflammatory drugs ( NSAIDs ) it can be associated with serious dose-related adverse events ( AEs ) .


Low-dose SoluMatrix diclofenac has been developed to provide efficacy at lower diclofenac doses .


A recently published Phase III study evaluated the efficacy and safety of SoluMatrix diclofenac @ mg twice daily ( b.i.d. ) and thrice daily ( t.i.d. ) in patients with OA pain treated for @ weeks .


This Phase III multicenter , open-label study assessed the safety of SoluMatrix diclofenac in patients with OA dosed up to @ weeks ( ClinicalTrials.gov : NCT@ ) .


The study enrolled @ chronic NSAID/acetaminophen users , aged @ years with OA of the knee or hip .


Patients received SoluMatrix diclofenac @ mg b.i.d. , which could be increased to t.i.d. and subsequently reduced to b.i.d. as needed .


Safety assessments included AEs , vital signs , physical examination findings , @-lead electrocardiogram , and clinical laboratory test results .


Patient-reported outcomes were evaluated by the Short Form-@ ( SF-@ ) .


A total of @ patients received SoluMatrix diclofenac ; @ of @ patients ( @ % ) received treatment for @ months .


The most frequent AEs included upper respiratory tract infection , headache , urinary tract infection , diarrhea , nasopharyngitis , and nausea .


Serious gastrointestinal , cardiovascular , renal , and hepatic AEs were uncommon .


A small proportion ( @ patients , @ % ) of patients discontinued participation in the study due to AEs .


Clinically meaningful improvements from baseline in Physical Component Summary Scores of the SF-@ were noted at week @ and were sustained through week @ .


Improvements in six of the eight individual physical and mental SF-@ domains were also noted .


SoluMatrix diclofenac treatment for up to @ year was generally well tolerated in patients with OA pain and associated with improvement in quality of life measures .


Obesity is a chronic disease with serious health consequences , but weight loss is difficult to maintain through lifestyle intervention alone .


Liraglutide , a glucagon-like peptide-@ analogue , has been shown to have potential benefit for weight management at a once-daily dose of @ mg , injected subcutaneously .


We conducted a @-week , double-blind trial involving @ patients who did not have type @ diabetes and who had a body-mass index ( BMI ; the weight in kilograms divided by the square of the height in meters ) of at least @ or a BMI of at least @ if they had treated or untreated dyslipidemia or hypertension .


We randomly assigned patients in a @:@ ratio to receive once-daily subcutaneous injections of liraglutide at a dose of @ mg ( @ patients ) or placebo ( @ patients ) ; both groups received counseling on lifestyle modification .


The coprimary end points were the change in body weight and the proportions of patients losing at least @ % and more than @ % of their initial body weight .


At baseline , the mean ( SD ) age of the patients was @ years , the mean weight was @ kg , and the mean BMI was @ ; a total of @ % of the patients were women and @ % had prediabetes .


At week @ , patients in the liraglutide group had lost a mean of @ kg of body weight , and those in the placebo group had lost a mean of @ kg ( a difference of -@ kg ; @ % confidence interval , -@ to -@ ; P < @ , with last-observation-carried-forward imputation ) .


A total of @ % of the patients in the liraglutide group as compared with @ % in the placebo group lost at least @ % of their body weight ( P < @ ) , and @ % and @ % , respectively , lost more than @ % of their body weight ( P < @ ) .


The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea .


Serious events occurred in @ % of the patients in the liraglutide group and in @ % of the patients in the placebo group .


In this study , @ mg of liraglutide , as an adjunct to diet and exercise , was associated with reduced body weight and improved metabolic control .


( Funded by Novo Nordisk ; SCALE Obesity and Prediabetes NN@-@ ClinicalTrials.gov number , NCT@ . )


Preliminary evidence suggests that improved nutrition early in HIV infection may delay progression to AIDS and delay the initiation or improve the effectiveness of antiretroviral drug therapy .


There are few studies that evaluate food-based interventions in drug-nave , HIV-infected women and their children .


Meat provides several nutrients identified as important in maintaining immune function and lean body mass .


To design supplemental meat and soybean biscuits for use in a randomized trial examining the effect of meat in the diet of drug-nave , HIV-infected rural Kenyan women on changes in weight , lean body mass , morbidity , nutritional status , and activities of daily living of the women and growth and development of their children .


We designed three supplemental biscuits : one with added dried beef another with added soybean flour , and a wheat biscuit to serve as a control biscuit to be used in a randomized feeding intervention in drug-nave , HIV-infected rural Kenyan women and their children .


The nutritional contents of the different types of biscuit were examined and compared .


The three biscuits were isocaloric .


Meat biscuits provided more lysine , vitamin B@ , and bioavailable zinc .


Soybean biscuits provided more total and absorbable iron ; however , higher fiber and phytate contents may inhibit nutrient absorption .


Data analysis for clinical outcomes of the trial is ongoing .


The `` biscuit model '' is useful for nutrition supplementation studies because it can be provided in a blinded and randomized fashion , safely and privately in a home under directly observed consumption by a highly stigmatized population .


It is well received by adults and children , and the biscuits can be produced locally with available , simple , affordable technology .


Novel interventions are needed to improve adherence to treatment in adolescents with type @ diabetes .


In this article , we describe the development , feasibility , and acceptability of a positive psychology intervention for this population .


Adolescents and their parents ( n = @ ) were randomly assigned to either a positive psychology intervention or an attention control group .


Quantitative and qualitative data were collected on feasibility and acceptability .


Descriptive and content analysis methods were used .


Recruitment was successful , participation and satisfaction were high in both groups , and retention was excellent over @months .


In the positive psychology group , adolescents and their parents noted benefits related to increased positive communication and thinking more about diabetes care .


We also identified challenges to implementation .


Although more research is indicated , a positive psychology framework emphasizing positive emotions and strengths , rather than problems , may be beneficial to adolescents living with a complex chronic illness .


To determine the effects of hormone therapy ( HT ) on ischemia modified albumin ( IMA ) and soluble ( s ) CD@ ligand in obese surgical menopausal women .


A total of @ obese surgical menopausal women with a body mass index ( BMI ) > @ kg/m@ were admitted to the study .


Twenty-seven women received estradiol hemihydrate two mg and @ did not receive any menopausal therapy .


At baseline and after three and six months of treatment , IMA and sCD@ ligand levels were measured .


There were no significant differences among the groups for any variables at baseline .


No difference in change in the serum sCD@L levels was found in obese surgical menopausal women after three and six months of HT .


Serum IMA levels were statistically lowered in obese women with HT after six months of treatment .


HT may have a beneficial reduction in IMA levels in obese surgical menopausal women .


There is uncertainty over which characteristics increase obstructive sleep apnea syndrome ( OSAS ) severity in children .


In candidates for adenotonsillectomy ( AT ) , we evaluated the relationship of OSAS severity and age , sex , race , body mass index ( BMI ) , environmental tobacco smoke ( ETS ) , prematurity , socioeconomic variables , and comorbidities .


Cross-sectional screening and baseline data were analyzed from the Childhood Adenotonsillectomy Trial , a randomized , controlled , multicenter study evaluating AT versus medical management .


Regression analysis assessed the relationship between the apnea hypopnea index ( AHI ) and risk factors obtained by direct measurement or questionnaire .


Clinical referral setting .


Children , ages @ to @ y with OSAS .


Of the @,@ children undergoing screening polysomnography , @ ( @ % ) were eligible ( @ AHI < @ or @ obstructive apnea index -LSB- OAI -RSB- < @ and without severe oxygen desaturation ) and randomized ; @ ( @ % ) were eligible but were not randomized ; @ ( @ % ) had AHI/OAI levels below entry criteria ; and @ ( @ % ) had levels of OSAS that exceeded entry criteria .


Among the randomized children , univariate analyses showed significant associations of AHI with race , BMI z score , environmental tobacco smoke ( ETS ) , family income , and referral source , but not with other variables .


After adjusting for potential confounders , African American race ( P = @ ) and ETS ( P = @ ) were each associated with an approximately @ % increase in AHI .


After adjusting for these factors , obesity and other factors were not significant .


Apnea hypopnea index level was significantly associated with race and environmental tobacco smoke , highlighting the potential effect of environmental factors , and possibly genetic factors , on pediatric obstructive sleep apnea syndrome severity .


Efforts to reduce environmental tobacco smoke exposure may help reduce obstructive sleep apnea syndrome severity .


Antibiotic therapy during pregnancy may be beneficial and impacts positively on the reduction of adverse pregnancy outcomes .


No studies have been done so far on the effects of daily Co-trimoxazole ( CTX ) prophylaxis on birth outcomes .


A phase @b randomized trial was conducted to establish that daily CTX in pregnancy is not inferior to SP intermittent preventive treatment ( IPT ) in reducing placental malaria ; preventing peripheral parasitaemia ; preventing perinatal mortality and also improving birth weight .


To establish its safety on the offspring by measuring the gestational age and birth weight at delivery , and compare the safety and efficacy profile of CTX to that of SP .


Pregnant women ( HIV infected and uninfected ) attending antenatal clinic were randomized to receive either daily CTX or sulfadoxine-pyrimethamine as per routine IPT .


Safety was assessed using standard and pregnancy specific measurements .


Women were followed up monthly until delivery and then with their offspring up to six weeks after delivery .


Data from @ pregnant women ( CTX = @ ; SP = @ ) and @ newborns ( CTX = @ and SP = @ ) showed that preterm deliveries ( CTX @ % ; SP @ % ) ; still births ( CTX @ % ; SP @ % ) , neonatal deaths ( CTX @ % ; SP @ % ) , and spontaneous abortions ( CTX @ % ; SP @ % ) were similar between study arms .


The low birth weight rates were @ % for CTX and @ % for SP .


There were no birth defects reported .


Both drug exposure groups had full term deliveries with similar birth weights ( mean of @ Kg ) .


The incidence and severity of AEs in the two groups were comparable .


Exposure to daily CTX in pregnancy may not be associated with particular safety risks in terms of birth outcomes such as preterm deliveries , still births , neonatal deaths and spontaneous abortions compared to SP .


However , more data are required on CTX use in pregnant women both among HIV infected and un-infected individuals .


To compare the hemodynamic responses to orotracheal intubation following induction of anesthesia with propofol , ketamine-propofol , and ketamine-diazepam in premedicated dogs .


Prospective , randomized , masked study .


@ healthy adult Beagles .


Dogs were randomly allocated to be anesthetized twice , with a @-week wash-out interval , by means of @ of @ possible protocols ( propofol -LSB- @ mg/kg -LCB- @ mg/lb -RCB- , n = @ dogs -RSB- , ketamine -LSB- @ mg/kg -LCB- @ mg/lb -RCB- -RSB- and propofol -LSB- @ mg/kg ; @ -RSB- , or ketamine -LSB- @ mg/kg -LCB- @ mg/lb -RCB- -RSB- and diazepam -LSB- @ mg/kg -LCB- @ mg/lb -RCB- ; @ -RSB- ) .


After instrumentation , continuous heart rate , systolic arterial blood pressure , mean arterial blood pressure , diastolic arterial blood pressure , cardiac index , stroke volume index , and systemic vascular resistance were recorded .


Fifteen minutes after premedication , dogs were anesthetized ; all anesthetics were administered IV .


After @ minutes , orotracheal intubation was performed without the use of a laryngoscope .


Data were collected prior to intubation ( baseline ) , at intubation , and @ , @ , @ , @ , @ , and @ seconds thereafter .


Results were compared among the @ groups and over time .


No differences among groups were observed for any variables studied .


In all groups , arterial blood pressures were significantly decreased at various time points after intubation .


A significant increase in systolic arterial blood pressure was observed between baseline and the @-second time point in the ketamine-diazepam group .


No significant differences were detected over time for the other variables in any group .


Intubation after anesthetic induction with ketamine-diazepam caused transitory hypertension , whereas intubation after induction with propofol or ketamine-propofol did not cause cardiovascular stimulation .


In dogs in which hypertension is a concern , propofol or ketamine-propofol may be a better choice for induction prior to orotracheal intubation .


It is unknown whether women and men with acute ischemic stroke respond similar to an antioxidant regimen administered in combination with thrombolysis .


Here , we investigated the independent effect of sex on the response to uric acid ( UA ) therapy in patients with acute stroke treated with alteplase .


In the Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke ( URICO-ICTUS ) trial , @ women and @ men were randomized to UA @ mg or placebo .


In this reanalysis of the trial , the primary outcome was the rate of excellent outcome at @ days ( modified Rankin Scale , @-@ , or @ , if premorbid score of @ ) in women and men using regression models adjusted for confounders associated with sex .


The interaction of UA levels by treatment on infarct growth was assessed in selected patients .


Excellent outcome occurred in @ of @ ( @ % ) women treated with UA , and @ of @ ( @ % ) treated with placebo , and in @ of @ ( @ % ) men treated with UA and @ of @ ( @ % ) treated with placebo .


Treatment and sex interacted significantly with excellent outcome ( P = @ ) .


Thus , UA therapy doubled the effect of placebo to attain an excellent outcome in women ( odd ratio -LSB- @ % confidence interval -RSB- , @ -LSB- @-@ @ -RSB- ; P = @ ) , but not in men ( odd ratio -LSB- @ % confidence interval -RSB- , @ -LSB- @-@ @ -RSB- ; P = @ ) .


The interactions between treatment and serum UA levels ( P < @ ) or allantoin/UA ratio ( P < @ ) on infarct growth were significant only in women .


In women with acute ischemic stroke treated with alteplase , the administration of UA reduced infarct growth in selected patients and was better than placebo to reach excellent outcome .


The aim of this study was to evaluate a light-emitting diode fluorescence tool , the SOPROLIFE light-induced fluorescence evaluator , and compare it to the international caries detection and assessment system-II ( ICDAS-II ) in the detection of occlusal caries .


A total of @ permanent posterior teeth in @ subjects , with age ranging from @ to @ years , were examined .


An intraclass correlation coefficient ( ICC ) was computed to assess the reliability between the two diagnostic methods .


The results showed a high reliability between the two methods ( ICC = @ ; IC = @-@ @ ; P < @ ) .


The SOPROLIFE blue fluorescence mode had a high sensitivity ( @ % ) and a high specificity ( @ % ) when compared to ICDAS-II .


Compared to the most used visual method in the diagnosis of occlusal caries lesions , the finding from this study suggests that SOPROLIFE can be used as a reproducible and reliable assessment tool .


At a cut-off point , categorizing noncarious lesions and visual change in enamel , SOPROLIFE shows a high sensitivity and specificity .


We can conclude that financially ICDAS is better than SOPROLIFE .


However SOPROLIFE is easier for clinicians since it is a simple evaluation of images .


Finally in terms of efficiency SOPROLIFE is not superior to ICDAS but tends to be equivalent with the same advantages .


Treatment failure is a common phenomenon , but little is known about the reasons .


Therapeutic alliance , therapist adherence , and therapist competence are considered important aspects of treatment success and formed the focus of the current investigation .


Three randomized controlled trials for the treatment of depression , social phobia , and hypochondriasis were the basis of the current study .


The role of therapeutic alliance , as well as therapist adherence and competence , were investigated in @ patients , which were classified either as treatment failure or as treatment success .


Process variables were evaluated by independent raters on the basis of videotapes of the first three treatment sessions .


Therapists ' adherence and therapeutic alliance differed significantly between successful treatments and those classified as failures , whereas therapists ' competence did not .


In cross-sectional analysis , we found a moderating effect of adherence with alliance on treatment outcome , indicating that the better the therapeutic alliance , the stronger the effect of adherence on treatment outcome .


Moreover , higher therapists ' competence was found to affect treatment outcome positively , only mediated by therapeutic alliance .


Higher therapists ' adherence affected treatment outcome positively , only mediated by the competence-alliance relationship .


In additional longitudinal analyses , we found evidence that the therapeutic alliance within one session influences therapists ' adherence and competence in the subsequent session , but not the other way around .


Therapeutic alliance proved to be an important variable for the prediction of treatment failure .


Furthermore , in our longitudinal analyses , we found evidence that the therapeutic alliance is a precondition for the adherent and competent implementation of therapeutic techniques , which questions the results of our cross-sectional analysis and of previous research .


Clinical implications Treatment failure is associated with a lower therapeutic alliance in cognitive-behavioural treatment .


Therapeutic alliance seems to be an important precondition for the adherent and competent implementation of therapeutic techniques .


Therapeutic alliance should be monitored during psychotherapeutic treatment .


Cautions or limitations Results are limited to cognitive-behavioural therapy and may not be representative for other treatment approaches .


Process analyses are based on highly standardized randomized controlled trials and may not be generalizable to routine care .


Our aim was to explore the effectiveness of energy healing , a commonly used complementary and alternative therapy , on well-being in cancer patients while assessing the possible influence on the results of participating in a randomized controlled trial .


@ patients treated for colorectal cancer ( response rate : @ % ) were either ( a ) randomized to healing ( RH ) or control ( RC ) or ( b ) had self selected the healing ( SH ) or control condition ( SC ) , and completed questionnaires assessing well-being ( QoL , depressive symptoms , mood , and sleep quality ) , attitude toward complementary and alternative medicine ( CAM ) , and faith/spirituality at baseline , @ week , and @ months post-intervention .


They also indicated , at baseline , whether they considered QoL , depressive symptoms , mood , and sleep quality as important outcomes to them .


Multilevel linear models revealed no overall effect of healing on QoL ( p = @ ) , depressive symptoms ( p = @ ) , mood ( p = @ ) , or sleep quality ( p = @ ) in the intervention groups ( RH , SH ) compared with control ( SC ) .


Effects of healing on mood were only found for patients who had a positive attitude toward CAM and considered the outcome in question as important ( SH : Regression coefficient : -@ ; SE : @ ; CI : -@ to -@ ; p = @ , and RH : Regression coefficient -@ ; SE : @ ; CI : -@ to -@ ; p = @ ) .


Whereas it is generally assumed that CAMs such as healing have beneficial effects on well-being , our results indicated no overall effectiveness of energy healing on QoL , depressive symptoms , mood , and sleep quality in colorectal cancer patients .


Effectiveness of healing on well-being was , however , related to factors such as self-selection and a positive attitude toward the treatment .


The aim of this paper is to report a pilot study in which participants who had recently received a diagnosis of dementia were randomised to either a @-week group intervention or a waiting-list control .


Memory clinic staff with limited previous experience of group therapy were trained to lead a @-week group therapy intervention called ` Living Well with Dementia ' .


Fifty-eight participants , all of whom had received a diagnosis of Alzheimer 's disease , vascular or Lewy body dementia within the previous @ months , were randomised to receive either the intervention or treatment as usual ( waiting-list control ) .


Data collection occurred at baseline , within two weeks after the intervention finished and at @-week follow-up .


The study met its recruitment targets , with a relatively low attrition rate for the intervention arm .


The acceptability of the intervention and research methods was examined qualitatively and will be reported on elsewhere .


For the primary outcome , measure of quality of life in Alzheimer 's disease ( QoL-AD ) , and secondary outcome , self-esteem , there was some evidence of improvement in the intervention group compared to the control group .


There was , also , evidence of a reduction in cognitive functioning in the treatment group compared to the control .


Such reported differences should be treated with caution because they are obtained from a pilot and not a definitive study .


This pilot study succeeded in collecting data to inform a future definitive cost effectiveness clinical trial of Living Well with Dementia group therapy .


This study aimed to evaluate the fluoride concentration in the fingernails and toenails of children aged @-@ months during use of fluoride-containing toothpastes supplemented with calcium glycerophosphate ( CaGP ) or sodium trimetaphosphate ( TMP ) .


According to the toothpaste used , children ( n = @ ) were randomly assigned into three groups : @ g F/g with @ % TMP , @ g F/g with @ % CaGP , and @ g F/g .


Fingernails and toenails were collected monthly over a period of @ days , from the beginning of toothpaste use .


Fluoride concentration in the water consumed by the volunteers and fluoride intake from diet and toothpaste were also determined .


Fluoride analyses were performed with the electrode after hexamethyldisiloxane-facilitated diffusion or by the direct method , according to the samples .


Data passed normality and homoscedasticity tests and were analyzed by @-way analysis of variance ( anova ) and @-way anova followed by Student-Newman-Keuls test ( P < @ ) .


Fluoride levels in the fingernails and toenails as well as fluoride intake from toothpaste were similar for the groups treated with @ g F/g with @ % TMP and @ g F/g with @ % CaGP toothpastes , but significantly lower than the @ g F/g group ( P < @ ) .


No significant differences were noted among the groups regarding fluoride intake from diet and that by water consumed by the volunteers ( P > @ ) .


The results of the longitudinal study suggest that the level of fluoride present in nails was lower with the use of toothpastes with a low fluoride concentration .


Despite common use of intraoperative electrophysiologic neuromonitoring , injuries to the lumbar plexus during lateral lumbar interbody fusion ( LLIF ) have been reported .


Emerging data suggest that recombinant human bone morphogenetic protein-@ ( rhBMP-@ ) use during an anterior or transforaminal lumbar interbody fusion may be associated with an increased risk of neurological deficit .


Clinical data on the sequelae of rhBMP-@ implantation in close proximity to the lumbosacral plexus during LLIF remains to be understood .


The purpose of this study was to compare the incidence of neurologic deficits and pain in patients undergoing LLIF with and without rhBMP-@ .


Retrospective outcome analysis in controlled cohorts undergoing the lateral exposure technique for LLIF with and without rhBMP-@ .


The electronic medical records of patients undergoing LLIF with and without supplemental posterior fusion for degenerative spinal conditions were retrospectively reviewed over a @-year period .


Patients with previous lumbar spine surgery or follow-up of less than @ months were excluded .


Patients were divided into @ groups , Group @ ( rhBMP-@ use ; n = @ ) and Group @ ( autograft/allograft use ; n = @ ) , and were matched according to the age at the time of surgery , gender , weight , body mass index , side of approach , total number of treated spinal segments , use of supplemental posterior fusion , and length of follow-up .


Immediately after surgery , a sensory deficit was recorded in @ patients in Group @ and @ patients in Group @ ( odds ratio -LSB- OR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; p = @ ) .


At last follow-up , a persistent sensory deficit was identified in @ patients whose LLIF procedure was supplemented by rhBMP-@ and @ patients in whom autograft/allograft was used ( OR @ ; @ % CI @-@ @ ; p = @ ) .


A motor deficit was recorded in @ patients immediately after the rhBMP-@ procedure and @ patients treated with autograft/allograft ( OR @ ; @ % CI @-@ @ ; p = @ ) .


A persistent motor deficit was recorded in @ and @ patients in Groups @ and @ , respectively , at last follow-up ( OR @ ; @ % CI @-@ @ ; p = @ ) .


During the first postoperative examination , @ patients in Group @ and @ patients in Group @ complained of anterior thigh or groin pain ( OR @ ; @ % CI @-@ @ ; p = @ ) .


At last follow-up , there was a significantly higher number of patients in Group @ who complained of persistent anterior thigh or groin pain than Group @ ( @ vs. @ patients ) ( OR @ ; @ % CI @-@ @ ; p = @ ) .


Our results provide evidence of an increased rate of postoperative neurologic deficit and anterior thigh/groin pain after LLIF using rhBMP-@ , when compared with matched controls without rhBMP-@ exposure .


This study suggests a potential direct deleterious effect of rhBMP-@ on the lumbosacral plexus .


To examine whether larger bowls bias children toward requesting more food from the adults who serve them .


Study @ was a between-subject design involving @ preschool-age children who were randomized to receive either a small ( @ oz ) or large ( @ oz ) cereal bowl and were asked to tell researchers how much cereal they wanted for a morning snack .


Study @ was a within-subject design involving @ school-age children at a summer camp who were given a small ( @ oz ) cereal bowl on one day and a large ( @ oz ) cereal bowl on another day and asked by a cafeteria server how much cereal and milk they wanted for breakfast .


Hidden scales measured how much cereal and milk were served , consumed , and wasted .


Body mass index was calculated at the end of the study .


In study @ , the young children requested almost twice as much cereal to eat when presented with the larger bowl compared with the smaller bowl .


In study @ , the older children consumed @ % more and wasted @ % more when served in the larger bowl .


A step toward potentially reducing overeating and waste would be for parents and adult caregivers to use smaller bowls for serving food to children .


Predicting fluid responsiveness is crucial for fluid administration in septic shock patients .


Midazolam and propofol decrease vascular tone and venous return , which may influence preload dependency .


However , little is known about the effects of these two sedatives on preload dependency in septic shock patients .


We evaluated the effects of sedation with propofol or midazolam on preload dependency in septic shock patients who have been fluid resuscitated .


Forty-three septic shock patients who were undergoing early goal-directed therapy resuscitated within @ h were enrolled .


The patients were randomly divided into the midazolam group and the propofol group .


An initial passive leg-raising test ( PLR@ ) was performed to evaluate passive leg raising test ( PLR ) responsiveness .


Then , the patients were infused with midazolam or propofol .


After increasing the doses of the sedatives to titrate to a Ramsay @ score , a second passive leg raising test ( PLR@ ) was conducted to evaluate PLR responsiveness .


The primary end-point was the preload dependency before and after sedation with midazolam or propofol .


In the midazolam-PLR@-negative patients , there was no difference between the changes in the cardiac index induced by PLR@ ( PLR@ - cardiac function index -LSB- CI -RSB- ) and the changes in the cardiac index induced by PLR@ ( PLR@ - CI ) ( +@ % @ % versus +@ % @ % , P > @ ) .


However , in the propofol-PLR@-negative patients , there was a significant increase in the PLR - CI after sedation to a Ramsay @ score compared with a Ramsay @ score ( +@ % @ % versus +@ % @ % , P = @ ) .


There were no differences between PLR@ - CI and PLR@ - CI within the midazolam-PLR@-positive patients or within the propofol-PLR@-positive patients .


In titrating the sedation level from a Ramsay @ score to a Ramsay @ score , propofol but not midazolam increased preload dependency in septic shock patients with fluid nonresponsiveness .


This study used gated myocardial perfusion imaging ( G-MPI ) to assess the clinical value of Xinmailong injection in chronic congestive heart failure ( CHF ) .


A total of @ CHF patients were randomly divided into the control group ( n = @ ) and the Xinmailong group ( n = @ ) .


Patients in the control group were routinely treated .


Patients in the Xinmailong group were additionally treated with Xinmailong injection in addition to routine treatment .


Before and @ months after treatment , G-MPI was used to determine changes in the left ventricular ejection fraction ( LVEF ) , left ventricular end-diastolic volume ( LVEDV ) and left ventricular end-systolic volume ( LVESV ) .


Fourteen days after treatment , changes in plasma brain natriuretic peptide ( BNP ) levels were determined .


Before treatment , there were no significant differences in LVEF , LVEDV , LVESV , and BNP levels between the two groups ( all P > @ ) .


After treatment , LVEDV , LVESV , and BNP levels were significantly lower , and LVEF was significantly higher in the Xinmailong group than in the control group ( all P < @ ) .


Additional use of Xinmailong injection in addition to routine treatment improves cardiac function of CHF patients .


Because of the safety and effectiveness of Xinmailong injection ; this therapy should be promoted .


Cocoa flavanols are recognised by their favourable antioxidant and vascular effects .


This study investigates the influence on health of the daily consumption of ready-to-eat meals supplemented with cocoa extract within a hypocaloric diet , on middle-aged overweight/obese subjects .


Fifty healthy male and female middle-aged volunteers -LSB- @ years and body mass index ( BMI ) @ kg/m ( @ ) -RSB- were recruited to participate in a @ week randomised , parallel and double-blind study .


After following @ days on a low-polyphenol diet , @ volunteers received meals supplemented with @ g of cocoa extract ( @ mg of polyphenols ) and the other @ participants received control meals , within a @ % energy restriction diet .


On the @th week of intervention individuals in both dietary groups improved ( p < @ ) anthropometric , body composition , blood pressure and blood biochemical measurements .


Oxidised LDL cholesterol ( oxLDL ) , showed a higher reduction ( p = @ ) in the cocoa group .


Moreover , myeloperoxidase ( MPO ) levels decreased only in the cocoa supplemented group ( p = @ ) .


Intercellular Adhesion Molecule-@ ( sICAM-@ ) decreased significantly in both groups , while Vascular Cell Adhesion Molecule-@ ( sVCAM-@ ) did not present differences after the @ weeks of intervention .


Interestingly , cocoa intake showed a different effect by gender , presenting more beneficial effects in men .


The consumption of cocoa extract as part of ready-to-eat meals and within a hypocaloric diet improved oxidative status ( oxLDL ) in middle-aged subjects , being most remarkable in males .


The purpose of the study was to evaluate whether the biomembrane made of cartilage extracellular matrix , designed to provide cartilage-like favourable environments as well as to prevent against washout of blood clot after microfracture , would enhance cartilage repair compared with the conventional microfracture technique .


A prospective trial was designed to compare the biomembrane cover after microfracture with conventional microfracture among patients with grade III-IV symptomatic cartilage defect in the knee joint .


Patients aged @-@ years were assigned to either the microfracture/biomembrane ( n = @ ) or microfracture groups ( n = @ ) .


Among them , @ knees in the microfracture/biomembrane and @ knees in the microfracture were followed up for @ years .


Cartilage repair was assessed with magnetic resonance imagings taken @ months , @ year , and @ years postoperatively , and the clinical outcomes were also recorded .


Compared with conventional microfracture , microfracture/biomembrane resulted in greater degree of cartilage repair ( p = @ ) .


In the intra-group analysis , while microfracture showed moderate to good degree of cartilage repair in nearly @ % of the patients ( @ % at @ months to @ % at @ years ; n.s. ) , microfracture/biomembrane maintained an equivalent degree of repair up to @ years ( @ % at @ months to @ % at @ years ; n.s. ) .


The clinical outcome at @ years also showed improved knee score and satisfaction and decreased pain in each group , but the difference between the two groups was not statistically significant .


Compared with conventional microfracture , biomembrane cover after microfracture yielded superior outcome in terms of the degree of cartilage repair during @ years of follow-up .


This implies that initial protection of blood clot and immature repair tissue at the microfractured defect is important for the promotion of enhanced cartilage repair , which may be obtained by the application of a biomembrane .


Prospective comparative study , Level II .


Remote ischaemic pre-conditioning attenuates myocardial injury .


Because sulphonylurea drugs interfere with ischaemic and anaesthetic pre-conditioning , we assessed whether remote ischaemic pre-conditioning effects are altered in sulphonylurea-treated diabetics .


Using the database of our ongoing randomised , placebo-controlled study ( ClinicalTrials.gov NCT@ ) , we assessed the troponin I concentration area under curve ( measurements : baseline , @ , @ , @ , @ , @ , and @ h post-operatively ) in sulphonylurea-treated diabetics ( n = @ ) and non-diabetics ( n = @ ) without and with remote ischaemic pre-conditioning ( three @-min periods of left upper arm ischaemia with @-min reperfusion each ) during isoflurane anaesthesia before two - to three-vessel coronary artery surgery .


Remote ischaemic pre-conditioning in non-diabetic patients evoked a @ % decrease in the troponin I concentration area under curve ( @ ng/ml @ h @ vs. @ @ , P = @ ) but no change ( @ ng/ml @ h @ vs. @ @ , P = @ ) in sulphonylurea-treated diabetics .


There was no significant correlation between the troponin I concentration area under curve and arterial glucose concentrations , and the latter was not an independent confounder .


Cardioprotection by remote ischaemic pre-conditioning during isoflurane anaesthesia is abolished in sulphonylurea-treated diabetics .


Treatment algorithms for type @ diabetes recommend weight loss for disease management .


The safety and efficacy of treatment with phentermine ( PHEN ) / topiramate ( TPM ) extended release ( ER ) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized , double-blind , placebo-controlled @-week studies of obese/overweight adults with type @ diabetes .


The OB-@ / DM-@ Study was a @-week phase @ trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER @ mg/@ mg ( @/@ ) .


The primary end point was change in HbAc level .


A post hoc analysis of a subpopulation with type @ diabetes from a second study , CONQUER , is also presented .


All subjects made lifestyle modifications , and comorbidities were managed to the standard of care .


The study groups comprised @ subjects with type @ diabetes enrolled in the OB-@ / DM-@ Study ( mean baseline HbAc @ % -LSB- @ mmol/mol -RSB- ) and @ subjects with type @ diabetes in the CONQUER Study ( mean baseline HbA@c @ % -LSB- @ mmol/mol -RSB- ) .


At week @ in the OB-@ / DM-@ , change in weight ( from intent-to-treat sample with last observation carried forward -LSB- ITT-LOCF -RSB- ) was -@ % for placebo and -@ % for PHEN/TPM ER @/@ ( P < @ vs. placebo ) .


Change in HbA@c level ( from ITT-LOCF ) was -@ % ( -@ mmol/mol ) for placebo and -@ % ( -@ mmol/mol ) for PHEN/TPM ER @/@ ( P = @ ) .


In both the OB-@ / DM-@ and CONQUER , greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbAc targets with reduced need for diabetic medications when compared with the placebo group .


Common adverse events included paraesthesia , constipation , and insomnia .


PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type @ diabetes .


To determine the effects of SGB in BCRL patients and the efficacy of corticosteroids in SGB .


A double-blinded , randomized , controlled trial .


A single academic hospital , outpatient setting .


In total , @ patients with BCRL were recruited .


Patients were divided randomly into @ groups ( Group A : @ % bupivacaine @ mL , n = @ ; Group B : @ % bupivacaine @ mL + @ mg of triamcinolone @ mL , n = @ ; and Group C : @ % bupivacaine @ mL + @ mg of triamcinolone @ mL , n = @ ) .


All patients received @ consecutive SGBs , every @ weeks .


The primary outcomes were changes in forearm and upper arm circumference .


Circumference was measured at baseline , @ weeks ( before the second injection ) , @ weeks ( before the third injection ) , and @ weeks ( one month follow-up after @ consecutive SGBs ) .


Moreover , subjective data were collected using EORTC C-@ at baseline and @ weeks .


After @ consecutive SGBs , forearm and upper arm circumferences were decreased significantly from baseline in all groups ( P < @ / @ ) .


The upper arm circumference of group C was reduced significantly more than that of group A ( P < @ / @ ) .


The subjective data by EORTC-C@ at baseline and one month after @ consecutive SGBs revealed no statistically significant difference .


Relatively few patients were enrolled .


We did not compare SGB with any other BCRL treatment , such as complex decongestive therapy .


This study suggests that SGB may be an effective treatment for BCRL .


Furthermore , it appears that corticosteroids could have an additive effect in SGB .


To compare reduction of pain after laparoscopy for ablation or excision of endometriosis .


Prospective , randomized , double-blind study ( Canadian Task Force classification I ) .


Endometriosis and pelvic pain clinic at a university teaching hospital .


Women of reproductive age with pelvic pain and visually proved endometriosis .


Subjects completed a questionnaire rating various kinds of pain using visual analog scales ( VAS ) .


After visual identification subjects were randomized to treatment via ablation or excision by supervised training gynecologists as primary surgeons .


Follow-up questionnaires documented pain levels every @ months for @ year and then every @ months for @ years .


Change in pain VAS scores during @ years after the operation and rates of pregnancy , repeat surgery , and use of hormone therapy were evaluated .


There was a reduction in all pain scores over the @-year follow-up in both treatment groups .


A significantly greater reduction in dyspareunia VAS scores was observed in the excision group at @ years ( p = @ at univariate analysis , and p = @ at multivariate analysis ) .


More women in the ablation group continued to receive medical treatment of endometriosis at @ years ( p = @ ) .


Surgical treatment of endometriosis provides symptom reduction for up to @ years .


In some limited areas such as deep dyspareunia , excision is more effective than ablation .


The purpose of the present study was to compare the image quality of spinal magnetic resonance ( MR ) imaging performed on a high-field horizontal open versus a short-bore MR scanner in a randomized controlled study setup .


Altogether , @ ( @ % women , mean age @ ) consecutive patients underwent spine imaging after random assignement to a @-T horizontal open MR scanner with a vertical magnetic field or a @-T short-bore MR scanner .


This patient subset was part of a larger cohort .


Image quality was assessed by determining qualitative parameters , signal-to-noise ( SNR ) and contrast-to-noise ratios ( CNR ) , and quantitative contour sharpness .


The image quality parameters were higher for short-bore MR imaging .


Regarding all sequences , the relative differences were @ % for the mean overall qualitative image quality , @ % for the mean SNR values , and @-@ % for the quantitative contour sharpness ( P < @ ) .


The CNR values were also higher for images obtained with the short-bore MR scanner .


No sequence was of very poor ( nondiagnostic ) image quality .


Scanning times were significantly longer for examinations performed on the open MR scanner ( mean : @ min versus @ min ; P < @ ) .


In this randomized controlled comparison of spinal MR imaging with an open versus a short-bore scanner , short-bore MR imaging revealed considerably higher image quality with shorter scanning times .


To evaluate the effectiveness of a telephone-delivered behavioral weight loss and physical activity intervention targeting Australian primary care patients with type @ diabetes .


Pragmatic randomized controlled trial of telephone counseling ( n = @ ) versus usual care ( n = @ ) .


Reported here are @-month ( end-of-intervention ) and @-month ( maintenance ) primary outcomes of weight , moderate-to-vigorous-intensity physical activity ( MVPA ; via accelerometer ) , and HbA@c level .


Secondary outcomes include dietary energy intake and diet quality , waist circumference , lipid levels , and blood pressure .


Data were analyzed via adjusted linear mixed models with multiple imputation of missing data .


Relative to usual-care participants , telephone counseling participants achieved modest , but significant , improvements in weight loss ( relative rate -LSB- RR -RSB- -@ % of baseline body weight -LSB- @ % CI -@ to -@ % of baseline body weight -RSB- ) , MVPA ( RR @ -LSB- @ % CI @-@ @ -RSB- ) , diet quality ( @ -LSB- @ % CI @-@ @ -RSB- ) , and waist circumference ( -@ cm -LSB- @ % CI -@ to -@ cm -RSB- ) , but not in HbA@c level ( RR @ -LSB- @ % CI @-@ @ -RSB- ) , or other cardio-metabolic markers .


None of the outcomes showed a significant change/deterioration over the maintenance period .


However , only the intervention effect for MVPA remained statistically significant at @ months .


The modest improvements in weight loss and behavior change , but the lack of changes in cardio-metabolic markers , may limit the utility , scalability , and sustainability of such an approach .


To determine if prewarming of the i-gel ( Intersurgical , Wokingham , United Kingdom ) improves insertion and ventilation efficacy with muscle relaxation in patients undergoing elective surgery .


Clinical randomized study .


Operating room .


Sixty-eight adult patients scheduled for elective surgery under general anesthesia with American Society of Anesthesiologists physical status @-@ .


The i-gel was warmed to @C for @ minutes before insertion ( W group ; @ patients ) or kept at room temperature ( approximately @C ) ( C group ; @ patients ) .


The number of attempts for a successful insertion and the sealing pressure and leak volume @ seconds and @ minutes after initiating mechanical ventilation .


The total insertion attempts were @ ( W group , @ cases ; C group , @ cases ) and @ ( W group , @ cases ; C group , @ cases ) , which was significant ( P = @ ) .


Sealing pressure was significantly higher in the W group than the C group ( W group , @ @ cm H@O ; C group , @ @ cm H@O ; P = @ ) .


Leak volume was significantly smaller after @ seconds in the W group than the C group ( P = @ ) , but not after @ minutes ( P = @ ) .


Prewarming the i-gel to @C demonstrated a higher successful ventilation initiation .


Patterns of crow 's feet lines ( CFLs ) vary among individuals .


To characterize distribution and predictors of CFL patterns .


Patterns of CFLs ( full fan , lower fan , central fan , and upper fan ) were evaluated at maximum smile and at rest from photographs of subjects with moderate-to-severe CFLs .


Relationships between CFL pattern and severity , age , gender , and subject-reported outcomes were explored .


Evaluations of @,@ photographs from @,@ subjects were conducted ; @,@ and @,@ had evaluable CFL patterns at maximum smile and at rest , respectively .


Lower-fan , central-fan , and full-fan patterns were identified in @ % to @ % at maximum smile and @ % to @ % at rest ; upper fan was found in @ % .


The pattern distribution of CFLs demonstrated a relationship to baseline CFL severity , age , and gender ; full-fan and lower-fan patterns were more common in severe versus moderate CFL at maximum smile ; full fan increased with age .


Lower fan was more common in males .


Subjects with full fan at maximum smile were most dissatisfied with their appearance and perceived themselves to look older versus other patterns .


Baseline CFL severity , age , and gender may predict fan pattern .


Patterns may progress with age from central to lower fan or full fan .


Pattern heterogeneity of CFLs suggests that tailored treatment may be warranted .


Patients co-infected with human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) are at high risk for liver disease progression .


However , interferon-based treatments for HCV infection have significant toxicities , limiting treatment uptake .


To assess the all-oral @ direct-acting antiviral ( @D ) regimen of ombitasvir , paritaprevir ( co-dosed with ritonavir -LSB- paritaprevir/r -RSB- ) , dasabuvir , and ribavirin in HCV genotype @-infected adults with HIV-@ co-infection , including patients with cirrhosis .


TURQUOISE-I is a randomized , open-label study .


Part @a of this pilot study was conducted at @ sites in the United States and Puerto Rico between September @ and August @ and included @ patients with HCV genotype @ and HIV-@ co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy .


The study allowed enrollment of patients , including those with cirrhosis , with a CD@ + count of @/mm@ or greater or CD@ + percentage of @ % or more and plasma HIV-@ RNA suppressed while taking a stable atazanavir - or raltegravir-inclusive antiretroviral regimen .


Ombitasvir/paritaprevir/r , dasabuvir , and ribavirin for @ or @ weeks of treatment as randomized .


The primary assessment was the proportion of patients with sustained virologic response ( HCV RNA < @ IU/mL ) at posttreatment week @ ( SVR@ ) .


Among patients receiving @ or @ weeks of @D and ribavirin , SVR@ was achieved by @ of @ ( @ % ; @ % CI , @ % -@ % ) and @ of @ patients ( @ % ; @ % CI , @ % -@ % ) , respectively .


Of the @ patients who did not achieve SVR , @ withdrew consent , @ had confirmed virologic relapse or breakthrough , and @ patients had clinical history and phylogenetic evidence consistent with HCV reinfection .


The most common treatment-emergent adverse events were fatigue ( @ % ) , insomnia ( @ % ) , nausea ( @ % ) , and headache ( @ % ) .


Adverse events were generally mild , with none reported as serious or leading to discontinuation .


No patient had a confirmed HIV-@ breakthrough of @ copies/mL or greater during treatment .


In this open-label , randomized uncontrolled study , treatment with the all-oral , interferon-free @D-plus-ribavirin regimen resulted in high SVR rates among patients co-infected with HCV genotype @ and HIV-@ whether treated for @ or @ weeks .


Further phase @ studies of this regimen are warranted in patients with co-infection .


Fluid retention is a common complication of critical illness .


It typically results from large-volume fluid infusions during acute resuscitation and is worsened by hypoalbuminemia .


Recognized as edema , fluid retention is important for its association with delayed weaning and increased mortality .


The standard treatment is the administration of diuretics , with or without albumin .


We hypothesize that intravenous @ % albumin plus furosemide , by comparison with furosemide alone , improves diuresis , oxygenation , and hemodynamic stability in the deresuscitation of critically ill , hypoalbuminemic patients .


We propose a pilot study to determine the feasibility of a trial to investigate this hypothesis .


FADE is a single-center , parallel , pilot randomized controlled trial .


We aim to allocate @ hemodynamically stable , hypoalbuminemic adult patients receiving diuresis to treatment with either @ ml of either @ % albumin or normal saline placebo twice daily , for a total of six doses .


Diuretics are to be prescribed by the caregiving team at least twice daily , and administered within @ hours following study treatment .


Patients , intensive care unit ( ICU ) clinicians , data collectors , and outcome adjudicators will be blinded to treatment allocation .


Feasibility outcome measures include the proportion of patients receiving albumin within @ hours of diuretic , the proportion of patients receiving the full six doses of study treatment , the proportion of patients who receive open label @ % albumin , and the rate of recruitment .


Physiologic , laboratory , and clinical data are collected until discharge from the ICU or until @ days .


This is the first randomized trial to assess the use of hyperoncotic albumin in addition to diuretics in a general ICU population .


Should this pilot study demonstrate feasibility , the primary outcome measure of the larger clinical trial will be the number of ventilator-free days , with secondary clinical outcome measures of duration of mechanical ventilation , length of ICU stay , episodes of hemodynamic instability and mortality .


The addition of @ % albumin to standard diuretic therapy is a promising treatment in the post-resuscitation care of the critically ill patient .


Pulmonary hypertension due to left heart disease is very common .


Our aim was to investigate the relationship of the severity of left ventricular diastolic dysfunction with precapillary and postcapillary pulmonary hypertension ( PH ) in an elderly heart failure ( HF ) population .


A post hoc analysis of the Trial of Intensified Medical Therapy in Elderly Patients With Congestive Heart Failure data was done .


Baseline transthoracic echocardiography was used to categorize diastolic function , estimate pulmonary artery pressure and pulmonary capillary wedge pressure , and calculate the transpulmonary pressure gradient ( TPG ) .


Among @ HF patients , PH was present in @ % of patients with grade @ , in @ % of patients with grade @ , and in @ % of patients with grade @ diastolic dysfunction ; @ % of all HF patients with PH had a TPG > @ mm Hg , suggesting not only a postcapillary but also an additional precapillary component of PH. Survival was not related to the severity of diastolic dysfunction , but was worse in patients with PH ( hazard ratio @ , @ % confidence interval @-@ @ ; P = @ ) .


Our data indicate that HF patients with even mild diastolic dysfunction often have PH. Echocardiographic assessment suggest that the presence of PH might not simply be due to increased PCWP , but in part due to a precapillary component .


There is growing evidence from experimental studies that the acupuncture dose or technique influences the speed of onset of hypoalgesia .


The aim of this study was to investigate the effects of acupuncture using two or four needles on experimental contact thermal pain in healthy volunteers .


Forty two participants were randomised into three groups : four-needle group ( LI@ , LI@ , LI@ , TE@ ) , two-needle group ( verum at LI@ , LI@ and mock at LI@ , TE@ ) and mock acupuncture group ( LI@ , LI@ , LI@ , TE@ ) .


Each participant rated pain intensity ( visual analogue scale , VAS ) to a series of noxious stimuli administered to the forearm @C above the heat pain threshold during needling and immediately after removal of the needles .


Experimentally-induced heat pain intensity ( VAS ) during and after the intervention was lower than pre-intervention but there were no statistically significant differences in this change between groups .


There were no statistically significant differences between groups in the time taken for pain intensity to decrease by @ % from pre-intervention .


However , a @ % decrease in pain intensity within @min of needle insertion was observed for @ participants ( @ % ) in the four-needle group compared with @ % of participants in the two-needle group and @ % in the mock acupuncture group .


There was less variance in VAS in the four-needle group , suggesting more consistency in hypoalgesic response when using more needles .


There is tentative evidence that four needles may be superior to two needles in generating rapid onset hypoalgesia .


The findings suggest that further investigation is warranted .


Although conventional bariatric surgery results in weight loss , it does so with potential short-term and long-term morbidity .


To evaluate the effectiveness and safety of intermittent , reversible vagal nerve blockade therapy for obesity treatment .


A randomized , double-blind , sham-controlled clinical trial involving @ participants who had a body mass index of @ to @ or @ to @ and @ or more obesity-related condition was conducted at @ sites in the United States and Australia between May and December @ .


The @-month blinded portion of the @-year study was completed in January @ .


One hundred sixty-two patients received an active vagal nerve block device and @ received a sham device .


All participants received weight management education .


The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a @-point margin with at least @ % of patients in the vagal block group achieving a @ % loss and @ % achieving a @ % loss .


The primary safety objective was to determine whether the rate of serious adverse events related to device , procedure , or therapy in the vagal block group was less than @ % .


In the intent-to-treat analysis , the vagal nerve block group had a mean @ % excess weight loss ( @ % of their initial body weight loss ) vs @ % excess weight loss ( @ % initial body weight loss ) in the sham group .


The mean difference in the percentage of the excess weight loss between groups was @ percentage points ( @ % CI , @-@ @ ) , which did not meet the @-point target ( P = @ ) , although weight loss was statistically greater in the vagal nerve block group ( P = @ for treatment difference in a post hoc analysis ) .


At @ months , @ % of patients in the vagal nerve block group achieved @ % or more excess weight loss and @ % achieved @ % or more excess weight loss vs @ % in the sham group who achieved @ % or more loss and @ % who achieved @ % or more loss .


The device , procedure , or therapy-related serious adverse event rate in the vagal nerve block group was @ % ( @ % CI , @ % -@ % ) , significantly lower than the @ % goal .


The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy ; all were reported as mild or moderate in severity .


Among patients with morbid obesity , the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives , although weight loss in the vagal block group was statistically greater than in the sham device group .


The treatment was well tolerated , having met the primary safety objective .


The wahakura ( flax bassinet ) is presently being distributed as a safe infant sleeping device amongst New Zealand Mori , where sudden unexpected deaths in infancy ( SUDI ) rates are high .


It is promoted as mitigating bedsharing risk by providing a separate infant sleeping surface .


This study aimed to understand exactly what factors determine the apparent acceptability of the wahakura as an infant sleeping device to Mori mothers and other key Mori community stakeholders .


The qualitative study used face-to-face , semi-structured interviews , following Mori cultural protocols , to explore the experiences and views of @ Mori mothers and @ key informants who had wahakura experience .


We employed purposeful sampling of participants and thematic analysis of data .


The practical appeal of the wahakura related to its portability , the enabling of bedsharing and easier breastfeeding .


Considerable cultural and spiritual appeal was related to its native flax composition and traditional origin .


Health professionals found it useful to engage Mori women antenatally .


The study affirmed the acceptance of the wahakura as a culturally initiated endeavour , meaningfully engaging Mori mothers and families in SUDI risk mitigation .


It has the potential to capitalise on the benefits of bedsharing to enhance infant wellbeing while also safeguarding them from harm .


Breathlessness in patients with lung cancer is a common and distressing symptom affecting @-@ % of patients , rising to some @ % for those with advanced lung cancer .


The aim of the current study was to assess how feasible inspiratory muscle training ( IMT ) is in the lung cancer population and explore changes in outcome variables .


A pilot feasibility randomised trial was conducted in patients with clinically stable lung cancer .


The experimental group received training using a pressure threshold device .


Patients were instructed to carry out five IMT sessions weekly for @ weeks for a total of @ mins/day .


Patients in the control group received standard care .


Outcome measures were completed at baseline and monthly for @ months , and included : physiological parameters ( FEV@ , FVC ) ; perceived severity of breathlessness using six @-point NRS ; modified Borg Scale ; quality of life using the short form Chronic Respiratory Disease Questionnaire ; Hospital Anxiety and Depression Scale , and safety .


Forty-six patients ( M = @ , F = @ ) at a mean age of @ years old and a mean of @ months post-diagnosis who were not currently receiving chemotherapy and/or radiotherapy were recruited .


Seventy-percent had NSCLC and advanced disease .


Statistical ( area under the curve-AUC ) and clinically important differences were seen with regard to distress from breathlessness ( p = @ ) , ability to cope with breathlessness ( p = @ ) , satisfaction with breathlessness management ( p = @ ) , fatigue ( p = @ ) , emotional function ( p = @ ) , breathlessness mastery ( p = @ ) and depression ( p = @ ) .


The m-Borg difference between the two groups at @ months was @ , which is borderline clinically significant .


Changes were more evident in the @-month assessment where the effect of the intervention came to its peak .


This trial shows the IMT is feasible and potentially effective in patients with lung cancer .


These findings warrant a fully powered larger randomised controlled trial .


Needle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity .


Here we report the first comparison of Biojector and needle administration of a candidate rAd@ HIV vaccine .


Thirty-one adults , @-@ years , @ naive and @ prior rAd@ vaccine recipients were randomized to receive single rAd@ vaccine via needle or Biojector IM injection at @ PU in a Phase I open label clinical trial .


Solicited reactogenicity was collected for @ days ; clinical safety and immunogenicity follow-up was continued for @ weeks .


Overall , injections by either method were well tolerated .


There were no serious adverse events .


Frequency of any local reactogenicity was @/@ ( @ % ) for Biojector compared to @/@ ( @ % ) for needle injections .


There was no difference in HIV Env-specific antibody response between Biojector and needle delivery .


Env-specific antibody responses were more than @-fold higher in subjects receiving a booster dose of rAd@ vaccine than after a single dose delivered by either method regardless of interval between prime and boost .


Biojector delivery did not improve antibody responses to the rAd@ vaccine compared to needle administration .


Homologous boosting with rAd@ gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity .


To study different methods of treatment of patients with myofascial pain syndrome ( MFPS ) .


We evaluated the efficacy of complex treatment in @ patients with chronic tension-type headache ( ) and @ patients with facial MFPS .


The treatment included standard methods ( reflex therapy of and local injections of a combination of local anesthetics with small doses of steroids in trigger points in patients with facial MFPS .


To assess the efficacy of tizanidine , patients were randomized into two comparable groups .


The duration of the study was @ weeks .


The combined therapy , including reflex action and tizanidine , speeds recovery from pain and ensures the stability of results .


The long-term prognosis for localized pancreatic cancer ( PC ) remains poor .


Three randomized trials ( GEST phase III , JACCRO PC-@ phase II and GEMSAP phase II ) evaluated gemcitabine ( Gem ) with or without S-@ for patients with metastatic and locally advanced PC .


A pooled analysis based on published data examined whether Gem with S-@ ( GS ) is superior to Gem alone in overall survival ( OS ) in patients with locally advanced PC .


Data were extracted on @ patients : @ ( JACCRO ) , @ ( GEMSAP ) , and @ ( GEST ) .


OS was used for primary endpoint and progression-free survival ( PFS ) was used for secondary endpoint .


A general variance-based method was used to estimate the pooled HR and @ % CI between GS ( n = @ ) and Gem ( n = @ ) .


Meta-analysis demonstrated that the overall risk of death was significantly different between the two chemotherapies ( hazard ratio = @ , @ % confidence interval : @-@ @ , P = @ ) .


The median PFSs for GS and GEM in the JACCRO , GEMSAP , and GEST studies were @ , @ , and @ months , and @ , @ , and @ months , respectively ( P = @ ) .


The random-effect pooled estimate for @ patients showed the objective response rate ( ORR ) in the GS group ( @ % ) was better in the Gem group ( @ % , P = @ ) .


GS improved ORR , PFS and OS in patients with locally advanced PC over Gem alone .


GS could become one of the front-line chemotherapeutic agents .


Both delay discounting and depression are risk factors for cigarette smoking during adolescence .


However , very little research has explored associations between these variables in adolescent smokers and non-smokers .


Eighty adolescents were recruited based on depression status ( depressed and non-depressed ) and smoking status ( smokers and non-smokers ) to form four groups ( n = @ per group ) .


All participants completed a computerized monetary delay discounting task and a measure of depression .


Delay discounting and depression were significantly correlated .


Also , smokers ( both depressed and non-depressed ) and depressed non-smokers all discounted significantly more than non-smokers who were not depressed .


Depressed non-smokers and both groups of smokers did not differ in rate of delay discounting .


Adolescent non-smokers who are depressed discount similarly to adolescents who smoke and more than non-smokers who are not depressed .


Future research should explore the unique versus shared roles of delay discounting and depression as risk factors for smoking during adolescence .


To assess whether a @-week participant-driven health education programme offered to individuals with screening-detected hyperglycaemia in Danish primary care would lead to improvements in cardiovascular risk factors , health behaviour and patient-reported outcomes after @ years .


We conducted a randomized controlled trial in @ patients with screening-detected hyperglycaemia ( impaired fasting glucose , impaired glucose tolerance or type @ diabetes ) from @ general practices in Denmark .


Individuals were pre-randomized to receive ( i ) routine care ( n = @ ) , or ( ii ) an invitation to participate in the Ready to Act health education programme ( n = @ ) .


The programme was delivered over @ weeks in primary care and focused on motivation , action experience , informed decision-making and social involvement to promote health behaviour change .


The primary outcome was @-year modelled cardiovascular risk .


Of @ individuals , @ ( @ % ) received the intervention and @/@ individuals ( @ % ) returned for follow-up assessment .


There was no difference between the trial groups in modelled cardiovascular risk at @ years ( relative difference : @ ; @ % CI : @ to @ ) .


Total cholesterol was lower ( -@ mmol/l , @ % CI : -@ to -@ , P = @ ) , and patient activation was higher in the intervention than in the control group ( @ , @ % CI : @ to @ ) .


No other between-group differences were observed for any cardiovascular risk factor , health behaviour or patient-reported outcome variables .


Subgroup analyses suggested that the intervention was more beneficial in those with impaired fasting glucose/impaired glucose tolerance than in those with type @ diabetes .


For patients with screening-detected hyperglycaemia , a participant-driven health education programme was not associated with improvements in most clinical , behavioural and patient-reported outcomes after @ years of follow-up .


Latinos with type @ diabetes ( T@D ) face major healthcare access and disease management disparities .


We examined the impact of the Diabetes Among Latinos Best Practices Trial ( DIALBEST ) , a community health worker ( CHW ) - led structured intervention for improving glycemic control among Latinos with T@D .


A total of @ adult Latinos with poorly controlled T@D were randomly assigned to a standard of healthcare ( n = @ ) or CHW ( n = @ ) group .


The CHW intervention comprised @ individual sessions delivered at home by CHWs over a @-month period .


Sessions addressed T@D complications , healthy lifestyles , nutrition , healthy food choices and diet for diabetes , blood glucose self-monitoring , and medication adherence .


Demographic , socioeconomic , lifestyle , anthropometric , and biomarker ( HbA@c , fasting blood glucose , and lipid profile ) data were collected at baseline and @ , @ , @ , and @ months ( @ months postintervention ) .


Groups were equivalent at baseline .


Participants had high HbA@c at baseline ( mean @ % -LSB- @ mmol/mol -RSB- ) .


Relative to participants in the control group , CHWs had a positive impact on net HbA@c improvements at @ months ( -@ % -LSB- -@ mmol/mol -RSB- ) , @ months ( -@ % -LSB- -@ mmol/mol -RSB- ) , @ months ( -@ % -LSB- -@ mmol/mol -RSB- ) , and @ months ( -@ % -LSB- -@ mmol/mol -RSB- ) .


The overall repeated-measures group effect was statistically significant ( mean difference -@ % -LSB- -@ mmol/mol -RSB- , @ % CI -@ , -@ % -LSB- -@ , -@ mmol/mol -RSB- , P = @ ) .


CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the @ - and @-month visits .


There was no significant effect on blood lipid levels , hypertension , and weight .


DIALBEST is an effective intervention for improving blood glucose control among Latinos with T@D .


The aims of this study were to evaluate with microcomputed tomography the orthodontically induced inflammatory root resorption in premolars caused by buccopalatal jiggling movement with light and heavy forces and to compare it with the resorption caused by equivalent but continuous buccal forces .


The sample consisted of @ maxillary first premolars collected from @ patients ( @ girls , @ boys ; ages , @-@years ) who required orthodontic treatment with extractions .


They were divided into @ groups of @ patients .


Light ( @g ) or heavy ( @g ) buccal tipping orthodontic forces were randomly assigned on the maxillary right or left quadrant with either continuous buccal ( positive controls ) or buccopalatal jiggling forces for @weeks .


At the end of the experimental period , the teeth were carefully extracted and processed for @-dimensional imaging and volumetric evaluations of resorption craters .


Data were analyzed with Wilcoxon signed rank tests .


There was no statistically significant difference between positive control light ( P = @ ) and heavy ( P = @ ) continuous forces and jiggling forces for both force magnitudes .


However , statistically significant differences were observed between heavy and light jiggling forces ( P = @ ) , with heavy jiggling forces causing greater total root resorption than light jiggling forces .


Light and heavy jiggling forces in the buccopalatal direction did not cause significantly different amounts of root resorption when compared with continuous forces of the same magnitude .


On the other hand , light jiggling forces resulted in less root resorption than heavy jiggling forces .


Low bispectral index values frequently reflect EEG suppression and have been associated with postoperative mortality .


This study investigated whether intraoperative EEG suppression was an independent predictor of @ day postoperative mortality and explored risk factors for EEG suppression .


This observational study included @ adults enrolled in the B-Unaware or BAG-RECALL trials .


A cohort was defined with > @ cumulative minutes of EEG suppression , and @:@ propensity-matched to a non-suppressed cohort ( @ min suppression ) .


We evaluated the association between EEG suppression and mortality using multivariable logistic regression , and examined risk factors for EEG suppression using zero-inflated mixed effects analysis .


Ninety day postoperative mortality was @ % overall , @ % in the suppressed cohort , and @ % in the non-suppressed cohort -LCB- odds ratio ( OR ) -LSB- @ % confidence interval ( CI ) -RSB- = @ ( @-@ @ ) -RCB- .


After matching and multivariable adjustment , EEG suppression was not associated with mortality -LSB- OR ( @ % CI ) = @ ( @-@ @ ) -RSB- ; however , the interaction between EEG suppression and mean arterial pressure ( MAP ) < @ mm Hg was -LSB- OR ( @ % CI ) = @ ( @-@ @ ) -RSB- .


Risk factors for EEG suppression were older age , number of comorbidities , chronic obstructive pulmonary disease , and higher intraoperative doses of benzodiazepines , opioids , or volatile anaesthetics .


EEG suppression was less likely in patients with cancer , preoperative alcohol , opioid or benzodiazepine consumption , and intraoperative nitrous oxide exposure .


Although EEG suppression was associated with increasing anaesthetic administration and comorbidities , the hypothesis that intraoperative EEG suppression is a predictor of postoperative mortality was only supported if it was coincident with low MAP .


Atherosclerosis is strongly associated with an increased mortality in subjects with diabetes .


The carotid intima-media thickness ( IMT ) is commonly measured as a surrogate marker for cardiovascular risk .


Statins are well-established protective agents against atherosclerosis and reportedly suppress IMT progression in subjects with diabetes .


To clarify the effects of statins on subclinical atherosclerosis , we herein investigated changes in the carotid IMT and lipid profiles in a multi-center , prospective , randomized trial .


Hypercholesterolemic subjects with type @ diabetes were randomly assigned to open-label treatment with either pravastatin or pitavastatin .


The primary endpoint of this study was the IMT change after @ months of statin treatment .


A total of @ subjects ( @ pitavastatin ; @ pravastatin ) completed this @-month study .


The LDL-C decreased significantly from @ @ mg/dl at baseline to @ @ mg/dl at @ months in the pitavastatin group and from @ @ mg/dl to @ @ mg/dl in the pravastatin group .


The mean IMT showed moderate regression in both the pitavastatin ( -@ @ mm , P < @ ) and the pravastatin ( -@ @ mm ) group .


However , there was no significant difference in the IMT change between the two groups .


When the two groups were combined , the @-month change in the mean IMT was significantly associated with HDL-C change ( r = -@ , P = @ ) .


Multiple linear regression analysis revealed the change in HDL-C to be an independent variable showing a positive correlation with the carotid IMT reduction .


The administration of statins for @ years to subjects with type @ diabetes resulted in a significant regression of the carotid IMT .


An elevation of the plasma HDL-C with statin treatment was closely related to a regression of atherosclerosis .


The EGFR T@M mutation is the most common mechanism of drug resistance to epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors in patients who have lung cancer with an EGFR mutation ( EGFR-mutated lung cancer ) .


In preclinical models , the EGFR inhibitor AZD@ has been shown to be effective against both EGFR tyrosine kinase inhibitor-sensitizing and T@M resistance mutations .


We administered AZD@ at doses of @ to @ mg once daily in patients with advanced lung cancer who had radiologically documented disease progression after previous treatment with EGFR tyrosine kinase inhibitors .


The study included dose-escalation cohorts and dose-expansion cohorts .


In the expansion cohorts , prestudy tumor biopsies were required for central determination of EGFR T@M status .


Patients were assessed for safety , pharmacokinetics , and efficacy .


A total of @ patients were treated .


Among @ patients enrolled in the dose-escalation cohorts , no dose-limiting toxic effects occurred at the doses evaluated .


An additional @ patients were treated in five expansion cohorts .


The most common all-cause adverse events were diarrhea , rash , nausea , and decreased appetite .


The overall objective tumor response rate was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) .


Among @ patients with centrally confirmed EGFR T@M who could be evaluated for response , the response rate was @ % ( @ % CI , @ to @ ) .


In contrast , among @ patients without centrally detectable EGFR T@M who could be evaluated for response , the response rate was @ % ( @ % CI , @ to @ ) .


The median progression-free survival was @ months ( @ % CI , @ to not reached ) in EGFR T@M-positive patients and @ months ( @ % CI , @ to @ ) in EGFR T@M-negative patients .


AZD@ was highly active in patients with lung cancer with the EGFR T@M mutation who had had disease progression during prior therapy with EGFR tyrosine kinase inhibitors .


( Funded by AstraZeneca ; ClinicalTrials.gov number , NCT@ . )


Brimonidine tartrate ( BT ) @ % gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea .


To assess the @-minute speed of onset of topical BT @ % gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema .


Two Phase III , randomized , controlled studies with identical design in which subjects with moderate erythema of rosacea ( study A : n = @ ; study B : n = @ ) were randomized @:@ to apply topical BT @ % or vehicle gel once-daily for @ weeks .


Evaluations included severity of erythema based on Clinician 's Erythema Assessment ( CEA ) and Patient 's Self-Assessment ( PSA ) prior to study drug application and at @ minutes after application on days @ , @ , and @ .


@ % and @ % of subjects reported normal study completion for studies A and B , respectively .


The percentage of subjects achieving a @-grade improvement in both CEA and PSA was significantly increased at @ minutes post-dosing with BT @ % gel compared to vehicle gel on visit days ( day @ : @ vs @ % , P < @ ; day @ : @ vs @ % , P < @ ; Day @ : @ vs @ % , P < @ for BT @ % gel vs vehicle ) in study A. Similar results were shown for study B.


Once-daily topical BT gel @ % is not only efficacious at reducing facial erythema but also exhibits response within @ minutes of application in a significant number of patients throughout both Phase III studies .


Family caregivers provide invaluable support to stroke survivors during their recovery , rehabilitation , and community re-integration .


Unfortunately , it is not standard clinical practice to prepare and support caregivers in this role and , as a result , many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home .


We developed the Timing it Right Stroke Family Support Program ( TIRSFSP ) to guide the timing of delivering specific types of education and support to meet caregivers ' evolving needs .


The objective of this multi-site randomized controlled trial is to determine if delivering the TIRSFSP across the stroke care continuum improves caregivers ' sense of being supported and emotional well-being .


Our multi-site single-blinded randomized controlled trial will recruit @ family caregivers of stroke survivors from urban and rural acute care hospitals .


After completing a baseline assessment , participants will be randomly allocated to one of three groups : @ ) TIRSFSP guided by a stroke support person ( health care professional with stroke care experience ) , delivered in-person during acute care and by telephone for approximately the first six to @ months post-stroke , @ ) caregiver self-directed TIRSFSP with an initial introduction to the program by a stroke support person , or @ ) standard care receiving the educational resource `` Let 's Talk about Stroke '' prepared by the Heart and Stroke Foundation .


Participants will complete three follow-up quantitative assessments @ , @ , and @-months post-stroke .


These include assessments of depression , social support , psychological well-being , stroke knowledge , mastery ( sense of control over life ) , caregiving assistance provided , caregiving impact on everyday life , and indicators of stroke severity and disability .


Qualitative methods will also be used to obtain information about caregivers ' experiences with the education and support received and the impact on caregivers ' perception of being supported and emotional well-being .


This research will determine if the TIRSFSP benefits family caregivers by improving their perception of being supported and emotional well-being .


If proven effective , it could be recommended as a model of stroke family education and support that meets the Canadian Stroke Best Practice Guideline recommendation for providing timely education and support to families through transitions .


To determine whether rituximab , a monoclonal antibody against the B-lymphocyte antigen CD@ , is effective in the treatment of refractory noninfectious scleritis .


Prospective , dose-ranging , randomized , double-masked phase I/II clinical trial .


Twelve patients with noninfectious scleritis refractory to systemic corticosteroid and @ other systemic immunosuppressive agent were enrolled from January @ to March @ .


Subjects were randomly assigned to @ ( n = @ ) or @ mg ( n = @ ) dosing arms of rituximab intravenous infusions ( @ or @ mg ) , given at study days @ and @ .


Initial responders with breakthrough inflammation after study week @ were offered treatment with an additional cycle of @ open-label rituximab @ mg infusions .


Primary outcomes were reduction of inflammation , as measured with a validated scleritis disease grading scale ( SGS ) and reduction in corticosteroid dose by @ % .


Patients were characterized as responders to study therapy if @ of these endpoints showed improvement and neither showed evidence of worsening .


Secondary outcomes were improvement in visual acuity , reduction in pain , and improvement in patient and physician-reported global health assessment .


Of @ enrolled patients , @ met the SGS endpoint at or before week @ , and @ additionally were able to reduce corticosteroid dose by @ % .


With regard to secondary outcome measures , @ and @ patients showed improvement in patient and physician global health scores , respectively , and @ patients had reduction in pain .


Of @ initial responders , @ experienced breakthrough inflammation after @ weeks and were treated with a second cycle of rituximab infusions .


Four patients had significant objective or subjective worsening within @ weeks of receiving rituximab ; this event was averted in subsequent patients by treatment with peri-infusional oral corticosteroid .


No other significant adverse events were noted .


No differences in efficacy , toxicity , or likelihood of retreatment were noted between the dosing arms .


Rituximab was effective treatment for @ of @ enrolled patients with refractory , noninfectious scleritis at @ weeks , although @ required reinfusion with rituximab to maintain inflammatory control .


The treatment was well-tolerated , and peri-infusional inflammatory exacerbations were managed successfully with oral corticosteroids .


Further long-term studies are warranted to determine the safety and efficacy of rituximab in treating noninfectious scleritis and other ocular inflammatory diseases .


Distress screening guidelines call for rapid screening for emotional distress at the time of cancer diagnosis .


The purpose of this study was to examine the distress thermometer 's ( DT ) ability to screen in patients in treatment for advanced cancer who may be depressed .


Using cross-sectional data collected from patients within @ days of diagnosis with advanced cancer , this study used ROC analysis to determine the optimal-cutoff point of the distress thermometer ( DT ) for screening for depression as measured by the physician health questionnaire ( PHQ ) -@ ; inter-test reliability analysis to compare the DT with the PHQ-@ for screening in possible cases of depression , and multivariate analysis to examine associations among the DT emotional problem list ( EPL ) items with cases of depression .


The average age of the @ patients in the study was @ ( @ ) years .


Seventy ( @ % ) were female .


All had Stage @ or @ cancers ( @ % gastrointestinal , @ % gynecologic , @ % head and neck , @ % lung ) .


The mean DT score was @ ( @ ) / @ ; and @ ( @ % ) were depressed as measured by the PHQ-@ @ .


The optimal DT cut-off score to screen in possible cases of depression was @/@ , with a sensitivity of @ , compared to a sensitivity of @ of the PHQ-@ @ .


Correlation coefficients for the DT @ and the PHQ-@ with the PHQ-@ @ were @ and -@ , respectively .


EPL items associated with cases of depression were Depression ( OR = @ , @-@ @ ) and Sadness ( OR = @ , @-@ @ ) .


The optimal DT threshold for identifying possible cases of depression at the time of diagnosis is @ ; this threshold is more sensitive than the PHQ-@ @ .


EPL items may be used with the DT score to triage patients for evaluation .


Open-heart surgery with cardiopulmonary bypass ( CPB ) is associated with a generalized immune response and postoperative lung dysfunction .


Chemokines are involved in the pathogenesis of postoperative lung dysfunction .


We investigated whether continued mechanical ventilation during CPB has an impact on chemokine serum concentrations .


A total of @ patients undergoing coronary artery bypass graft operation were randomized to either continuous ventilated group ( n = @ ) or nonventilated group ( n = @ ) .


Blood samples were drawn at the beginning and at the end of surgery and on the @ consecutive days .


Serum CCL@ , CCL@ , and CCL@ concentrations were measured and given as mean standard deviation .


Chemokine concentrations were elevated at the end of surgery in both groups .


CCL@ and CCL@ levels returned to baseline on postoperative day ( POD ) -@ in the ventilation group and stayed elevated in the nonventilation group .


CCL@ serum levels were significantly lower in ventilated-group patients on POD-@ ( @ -LSB- @ -RSB- vs. @ -LSB- @ -RSB- ; p = @ ) , POD-@ ( @ -LSB- @ -RSB- vs. @ -LSB- @ -RSB- ; p = @ ) , POD-@ ( @ -LSB- @ -RSB- vs. @ -LSB- @ -RSB- ; p = @ ) , and POD-@ ( @ -LSB- @ -RSB- vs. @ -LSB- @ -RSB- ; p = @ ) .


Continued mechanical ventilation during CPB results in reduced CCL@ concentrations on POD-@ to -@ .


The Women 's Health Initiative ( WHI ) low-fat ( @ % kcal ) dietary modification ( DM ) trial ( @-@ ) demonstrated a nonsignificant reduction in breast cancer , a nominally significant reduction in ovarian cancer , and no effect on other cancers ( mean @ years intervention ) .


Consent to nonintervention follow-up was @ % ( n = @,@ ) .


This analysis was designed to assess postintervention cancer risk in women randomized to the low-fat diet ( @ % ) versus usual diet comparison ( @ % ) .


Randomized , controlled low-fat diet intervention for prevention of breast and colorectal cancers conducted in @,@ postmenopausal U.S. women , ages @ to @ years at @ U.S. sites .


Outcomes included total invasive cancer , breast cancer , and colorectal cancer , and cancer-specific and overall mortality .


There were no intervention effects on invasive breast or colorectal cancer , other cancers , or cancer-specific or overall mortality during the postintervention period or the combined intervention and follow-up periods .


For invasive breast cancer , the hazard ratios ( HR ) and @ % confidence interval ( CI ) were @ ( @-@ @ ) during intervention , @ ( @-@ @ ) during the postintervention period , and @ ( @-@ @ ) during cumulative follow-up .


A reduced risk for estrogen receptor positive/progesterone receptor-negative tumors was demonstrated during follow-up .


In women with higher baseline fat intake ( quartile ) , point estimates of breast cancer risk were HR , @ ( @ % CI , @-@ @ ) during intervention versus HR , @ ( @ % CI , @-@ @ ) during postintervention follow-up ( Pdiff = @ ) .


Dietary fat intake increased postintervention in intervention women ; no long-term reduction in cancer risk or mortality was shown in the WHI DM trial .


Dietary advisement to reduce fat for cancer prevention after menopause generally was not supported by the WHI DM trial .


Few randomized studies have investigated the impact of valved and non-valved power-injectable peripherally inserted central catheters ( PICCs ) in terms of incidence of occlusion , infection , malfunction and venous thrombosis .


We have prospectively compared three types of third-generation polyurethane PICCs .


One hundred and eighty adult patients candidate to chemotherapy were randomized into three groups : power-injectable PICCs with Solo-@ proximal valve ( Bard ) ; power-injectable PICCs with PASV ( Pressure Activated Safety Valve ) proximal valve ( Navilyst ) ; and non-valved power-injectable PICCs ( Medcomp ) .


All PICCs were single lumen @Fr , inserted according to a well-defined protocol - maximal barrier precautions , ultrasound guidance , intracavitary electrocardiography ( IC-ECG ) , and so on -- and managed according to the recommendations of the most recent guidelines ( antisepsis with @ % chlorhexidine , transparent dressing , sutureless device , strict ` scrub the hub ' policy , neutral displacement needle-free connectors and so on ) .


All catheters were flushed with @ ml saline before and after each infusion , or with @ ml saline after blood sampling or infusion of blood products .


No heparin was used .


We detected no complications at insertion ; no PICC-related bloodstream infections ; no dislocations ; five cases of transient occlusion and two cases of persistent withdrawal occlusion , evenly distributed among the groups ; one episode of complete irreversible obstruction ( group A ) ; four episodes of asymptomatic peripheral venous thrombosis ; one episode of symptomatic , severe central vein thrombosis ( group B ) .


In @ % of PICCs in group A ( @/@ ) and in @ % of group B ( @/@ ) , difficulties with gravity infusion were reported ; three PICCs of group A were complicated by rupture of the intravascular tract during pump infusion .


Five PICCs were removed because of complications , four in group A ( one obstruction ; three ruptures ) and one in group B ( central venous thrombosis ) .


We found no clinical advantages of valved vs. non-valved PICCs .


Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients .


Despite its increasing popularity and safety , the abdominal donor site remains a major source of postoperative pain .


Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids .


Opioids can cause numerous side effects such as sedation , headache , nausea , vomiting , breathing difficulties and bladder and bowel dysfunction .


A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block .


This study is a double-blind , placebo-controlled , randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction .


The primary objective of this study is compare the mean total opioid consumption in the first postoperative @ hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units .


The secondary outcome measures include the following parameters : total in-hospital cumulative opioid consumption ; daily patient-reported pain scores ; total in-hospital cumulative anti-nausea consumption ; nausea and sedation scores ; and Quality of Recovery score ; time to first bowel movement , ambulation , and duration of hospital stay .


Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America .