Instances of moderation differing significantly between @ - and @ months were : baseline physical activity for physical activity ( initiation ) and marital status for fat intake ( maintenance ) .


This exploratory study showed that moderation of physical activity and diet effects sometimes differed between initiation and maintenance .


To identify unique moderators for initiation and/or maintenance of behavior changes , future studies need to report on and statistically test for such differences .


The role of a low glycemic index ( GI ) diet in the management of adolescent obesity remains controversial .


In this study , we aim to evaluate the impact of low GI diet versus a conventional Chinese diet on the body mass index ( BMI ) and other obesity indices of obese adolescents .


Obese adolescents aged @-@years were identified from population-recruited , territory-wide surveys .


Obesity was defined as BMI @th percentile of Hong Kong local age - and sex-specific references .


Eligible subjects were randomized to either an intervention with low GI diet ( consisting of @-@ % carbohydrate , @-@ % fat and @-@ % protein ) or conventional Chinese diet as control ( consisting of @-@ % carbohydrate , @-@ % fat and @-@ % protein ) .


We used random intercept mixed effects model to compare the differential changes across the time points from baseline to month @ between the @ groups .


@ obese adolescents were recruited ( @ in low GI group and @ in control group ; @ % boys ) .


Mean age was @ years and @ @ years in low GI and control group respectively .


@ % subjects completed the study at @months ( @ % in low GI group and @ % in control group ) .


After adjustment for age and sex , subjects in the low GI group had a significantly greater reduction in obesity indices including BMI , body weight and waist circumference ( WC ) compared to subjects in the control group ( all p < @ ) .


After further adjustment for physical activity levels , WC was found to be significantly lower in the low GI group compared to the conventional group ( p = @ ) .


Low GI diet in the context of a comprehensive lifestyle modification program may be an alternative to conventional diet in the management of obese adolescents .


The ( C ) ce ( s ) haplotype , mainly found in black individuals , contains two altered genes : a hybrid RHD-CE-D ( s ) gene segregated with a ce ( s ) allele of RHCE with two single nucleotide polymorphisms , c. @C > G ( p.Leu@Val ) in exon @ and c. @G > T ( Gly@Cys ) in exon @ .


This haplotype could be responsible for false positive genotyping results in RhD-negative individuals and at a homozygous level lead to the loss of a high incidence antigen RH@ .


The aim of this study was to screen for the ( C ) ce ( s ) haplotype in Tunisian blood donors , given its clinico-biological importance .


Blood samples were randomly collected from blood donors in the blood transfusion centre of Sousse ( Tunisia ) .


A total of @ RhD-positive and @ RhD-negative samples were tested for the ( C ) ce ( s ) haplotype using two allele-specific primer polymerase chain reactions that detect c. @C > G ( p.Leu@Val ) and c. @G > T ( p. Gly@Cys ) substitutions in exon @ and @ of the RHCE gene .


In addition , the presence of the D-CE hybrid exon @ was evaluated using a sequence-specific primer polymerase chain reaction .


Among the @ individuals only five exhibited the ( C ) ce ( s ) haplotype in heterozygosity , for a frequency of @ % .


On the basis of the allele-specific primer polymerase chain reaction results , the difference in ( C ) ce ( s ) haplotype frequency was not statistically significant between RhD-positive and RhD-negative blood donors .


These data showed the presence of the ( C ) ce ( s ) haplotype at a low frequency ( @ % ) compared to that among Africans in whom it is common .


Nevertheless , the presence of RHD-CE-D ( s ) in Tunisians , even at a lower frequency , should be considered in the development of a molecular genotyping strategy for Rh genes , to ensure better management of the prevention of alloimmunisation .


To evaluate the effect of dry needling into a myofascial trigger point ( MTrP ) in the lower trapezius muscle of patients with mechanical idiopathic neck pain .


A single-center , randomized , double-blinded controlled study .


Patients were recruited from the student population of a local hospital by advertisement in the university clinic from January @ to December@ .


Patients ( N = @ ) with unilateral neck pain , neck pain for @ months , and active trigger points in the lower trapezius muscle were randomly assigned to @ of @ treatment groups .


All the patients completed the study .


Dry needling in an MTrP in the lower trapezius muscle , or dry needling in the lower trapezius muscle but not at an MTrP .


The visual analog scale ( VAS ) , Neck Pain Questionnaire ( NPQ ) , and pressure-pain threshold ( PPT ) were assessed before the intervention and @ week and @ month postintervention .


Treatment with dry needling of the lower trapezius muscle close to the MTrP showed decreases in pain and PPT as well as an improvement in the degree of disability ( P < @ ) compared with the baseline and control group measurements ( P < @ ) .


The dry-needling technique performed in the MTrP showed more significant therapeutic effects ( P < @ ) .


The application of dry needling into an active MTrP of the lower trapezius muscle induces significant changes in the VAS , NPQ , and PPT levels compared with the application of dry needling in other locations of the same muscle in patients with mechanical neck pain .


Assess the steady-state pharmacokinetics , pharmacodynamics and safety of once-daily ( q.d. ) versus twice-daily ( b.i.d. ) dosing with canagliflozin at the same total daily doses of @ and @ mg in healthy participants .


@ participants ( @ in each cohort ) were enrolled in this single-center , open-label , multiple-dose , @-cohort , @-way crossover study .


Participants in each cohort received a total daily dose of either @ or @ mg canagliflozin for @ days with q.d. then b.i.d. dosing or vice versa .


Pharmacokinetics and pharmacodynamics were assessed on day @ of each period .


The canagliflozin Cmax , ss of @ and @ mg q.d. dosing were higher by @ % and @ % than corresponding morning Cmax , ss of the @ mg and @ mg b.i.d. regimen , respectively .


The geometric mean ratios ( @ % CI ) of b.i.d. / q.d. for AUC@-@h , ss at total doses of @ and @ mg were @ ( @ ; @ ) and @ ( @ ; @ ) respectively .


Median tmax and mean t@/@ were independent of dose and regimen .


Mean ( SE ) @-h mean renal glucose threshold values for b.i.d. and q.d. regimens were @ ( @ ) and @ ( @ ) mg/dL for the @ mg daily doses and @ ( @ ) and @ ( @ ) mg/dL for the @ mg daily doses .


Mean ( SE ) values of @-h urinary glucose excretion for b.i.d. and q.d. regimens were @ ( @ ) and @ ( @ ) g for the @ mg daily doses and @ ( @ ) and @ ( @ ) g for the @ mg daily doses .


Both doses were safe and well tolerated .


Pharmacokinetics and pharmacodynamics of canagliflozin administered q.d. relative to b.i.d. at the same @ and @ mg total daily doses were comparable .


Overall , canagliflozin was well tolerated .


Assess ustekinumab efficacy ( week @/week @ ) and safety ( week @/week @/week @ ) in patients with active psoriatic arthritis ( PsA ) despite treatment with conventional and/or biological anti-tumour necrosis factor ( TNF ) agents .


In this phase @ , multicentre , placebo-controlled trial , @ adults with active PsA were randomised ( stratified by site , weight ( @ kg / > @ kg ) , methotrexate use ) to ustekinumab @ mg or @ mg at week @ , week @ , q@ weeks or placebo at week @ , week @ , week @ and crossover to ustekinumab @ mg at week @ , week @ and week @ .


At week @ , patients with < @ % improvement in tender/swollen joint counts entered blinded early escape ( placebo@ mg , @ mg@ mg , @ mg@ mg ) .


The primary endpoint was @ % improvement in American College of Rheumatology ( ACR@ ) criteria at week @ .


Secondary endpoints included week @ Health Assessment Questionnaire-Disability Index ( HAQ-DI ) improvement , ACR@ , ACR@ and @ % improvement in Psoriasis Area and Severity Index ( PASI@ ) .


Efficacy was assessed in all patients , anti-TNF-nave ( n = @ ) patients and anti-TNF-experienced ( n = @ ) patients .


More ustekinumab-treated ( @ % combined ) than placebo-treated ( @ % ) patients achieved ACR@ at week @ ( p < @ ) .


Significant treatment differences were observed for week @ HAQ-DI improvement ( p < @ ) , ACR@ ( p@ @ ) and PASI@ ( p < @ ) ; all benefits were sustained through week @ .


Among patients previously treated with @ TNF inhibitor , sustained ustekinumab efficacy was also observed ( week @ combined vs placebo : ACR@ @ % vs @ % , PASI@ @ % vs @ % , median HAQ-DI change -@ vs @ ; week @ ustekinumab-treated : ACR@ @ % , PASI@ @ % , median HAQ-DI change -@ ) .


No unexpected adverse events were observed through week @ .


The interleukin-@ / @ inhibitor ustekinumab ( @/@ mg q@ weeks ) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA , including anti-TNF-experienced PsA patients .


Progesterone vaginal insert ( PVI ) , an effervescent delivery system , dissolves rapidly , is absorbed through the vaginal epithelium , and achieves higher endometrial tissue concentrations than those achieved with progesterone in oil ( PIO ) given im .


Our objective was to examine the pharmacokinetics and pharmacodynamics of PVI compared with PIO .


Fifty-eight healthy premenopausal women were randomized to @ , @ , or @ mg PVI once daily ; @ or @ mg PVI twice daily ; or @ to @ mg PIO via im injection once daily for @ days .


Serum samples were obtained after the first dose ; serum and endometrial tissue were obtained after the last dose .


Maximum observed serum concentration ( Cmax ) , time to Cmax , and area under the serum-concentration time curve over the dosing interval were calculated after correcting for baseline progesterone concentrations .


ANOVA and paired t test were used to compare results across and within groups .


A higher Cmax was observed after PIO than PVI administration .


Endometrial tissue progesterone concentrations were higher for PVI regimens .


Time to Cmax was @ hours after PIO and @ to @ hours after PVI .


Steady state was achieved within @ and @ hours for PVI and PIO regimens , respectively .


The area under the curve increased with increasing PVI dosage ; however , the increase was not proportional to the increase in dosage .


Downregulation of estrogen and progesterone receptors was observed in secretory biopsy specimens .


The PVI system consistently allowed for rapid progesterone absorption and achieved higher endometrial tissue concentrations and lower systemic exposures than observed after im PIO .


Pioglitazone is a thiazolidinedione ( TZD ) insulin sensitizer approved for use in human type @ diabetes mellitus .


Therapeutic options for diabetes in cats are limited .


To evaluate the effects of pioglitazone in obese cats , which are predisposed to insulin resistance , to assess its potential for future use in feline diabetes mellitus .


A total of @ obese purpose-bred research cats ( @ neutered males and @ spayed females , @-@ years of age , weighing @-@ @ kg ) .


Randomized , placebo-controlled @-way crossover study .


Oral placebo or pioglitazone ( Actos ; @ or @ mg/kg ) was administered daily for @-week periods , with IV glucose tolerance testing before and after each period .


Three mg/kg pioglitazone significantly improved insulin sensitivity ( geometric mean -LSB- @ % CI -RSB- @ -LSB- @-@ @ -RSB- to @ -LSB- @-@ @ -RSB- minpmolL ; P = @ versus change with placebo ) , reduced insulin area under the curve during IVGTT ( geometric mean -LSB- range -RSB- @ -LSB- @-@ -RSB- to @ -LSB- @-@ -RSB- minnmol/L ; P = @ versus change with placebo ) , and lowered serum triglyceride ( geometric mean -LSB- range -RSB- @ -LSB- @-@ -RSB- to @ -LSB- @-@ -RSB- mg/dL ; P = @ versus change with placebo ) and cholesterol ( geometric mean -LSB- range -RSB- @ -LSB- @-@ -RSB- to @ -LSB- @-@ -RSB- mg/dL ; P = @ versus change with placebo ) concentrations in the obese cats .


No adverse effects attributable to pioglitazone were evident in the otherwise healthy obese cats at this dosage and duration .


Results of this study support a positive effect of pioglitazone on insulin sensitivity and lipid metabolism in obese cats , and suggest that further evaluation of the drug in cats with diabetes mellitus or other metabolic disorders might be warranted .


Nonalcoholic fatty liver disease ( NAFLD ) , characterized by accumulation of hepatic triglycerides ( steatosis ) , is associated with abdominal obesity , insulin resistance , and inflammation .


Although weight loss via calorie restriction reduces features of NAFLD , there is no pharmacologic therapy .


Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism .


We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD .


Overweight or obese men diagnosed with NAFLD were recruited from hepatology outpatient clinics in Brisbane , Australia from @ through @ .


They were randomly assigned to groups given @ mg resveratrol ( n = @ ) or placebo ( n = @ ) daily for @ weeks .


Outcomes included insulin resistance ( assessed by the euglycemic-hyperinsulinemic clamp ) , hepatic steatosis , and abdominal fat distribution ( assessed by magnetic resonance spectroscopy and imaging ) .


Plasma markers of inflammation , as well as metabolic , hepatic , and antioxidant function , were measured ; transcription of target genes was measured in peripheral blood mononuclear cells .


Resveratrol pharmacokinetics and safety were assessed .


Eight-week administration of resveratrol did not reduce insulin resistance , steatosis , or abdominal fat distribution when compared with baseline .


No change was observed in plasma lipids or antioxidant activity .


Levels of alanine and aspartate aminotransferases increased significantly among patients in the resveratrol group until week @ when compared with the placebo group .


Resveratrol did not significantly alter transcription of NQO@ , PTP@B , IL@ , or HO@ in peripheral blood mononuclear cells .


Resveratrol was well-tolerated .


Eight weeks administration of resveratrol did not significantly improve any features of NAFLD , compared with placebo , but it increased hepatic stress , based on observed increases in levels of liver enzymes .


Further studies are needed to determine whether agents that are purported to mimic calorie restriction , such as resveratrol , are safe and effective for complications of obesity .


Clinical trials registration no : ACTRN@ .


To compare the efficacy of aspirin and warfarin for prophylaxis of thrombosis in patients undergoing total cavopulmonary anastomosis .


Evaluate whether coagulation factors ( VII , VIII and protein C ) , clinical data , fenestration or hemodynamic factors , interfere with postoperative thrombosis .


A prospective , randomized study of @ patients , randomized into Group I ( Warfarin ) and Group II ( AAS ) , underwent total cavopulmonary shunt with extracardiac conduit , between @ and @ , with follow-up by clinical visits to evaluate side effects and adhesion .


Performed transesophageal echocardiography in post operatory time , @ , @,@ and @ months ; angiotomography at @ , @ and @ months to evaluate changes in the internal tube wall or thrombi and pulmonary scintigraphy to evaluate possible PTE .


Two deaths in group I ; @ % of patients had thrombus ( @ % in Group II ) .


The previous occurrence of thrombus and low levels of coagulation protein C were the only factors that influenced the time free of thrombus ( P = @ and @ ) .


Angiotomographic evaluation : @ % in group II presented material accumulation greater than @ mm ( P = @ ) .


Scintigraphy : two patients had PTE in group II .


Five patients had difficulty to comply with the treatment , @ in group I with INR ranging from @ to @ .


The previous occurrence of thrombus is a risk factor for thrombosis in the postoperative period .


Patients using AAS tend to deposit material in the tube wall .


The small sample size did not allow to conclude which is the most effective drug in the prevention of thrombosis in this population .


This randomized trial investigated voice rest and supplemental text-to-speech communication versus voice rest alone on visual analog scale measures of communication effectiveness and magnitude of voice use .


Randomized clinical trial .


Multicenter outpatient voice clinics .


Thirty-seven patients undergoing phonomicrosurgery .


Patients undergoing phonomicrosurgery were randomized to voice rest and supplemental text-to-speech communication or voice rest alone .


The primary outcome measure was the impact of voice rest on ability to communicate effectively over a @-day period .


Pre - and postoperative magnitude of voice use was also measured as an observational outcome .


Patients randomized to voice rest and supplemental text-to-speech communication reported higher median communication effectiveness on each postoperative day compared to those randomized to voice rest alone , with significantly higher median communication effectiveness on postoperative days @ ( P = @ ) and @ ( P = @ ) .


Magnitude of voice use did not differ on any preoperative ( P > @ ) or postoperative day ( P > @ ) , nor did patients significantly decrease voice use as the surgery date approached ( P > @ ) .


However , there was a significant reduction in median voice use pre - to postoperatively across patients ( P < @ ) with median voice use ranging from @ to @ throughout the postoperative week .


Supplemental text-to-speech communication increased patient-perceived communication effectiveness on postoperative days @ and @ over voice rest alone .


With the prevalence of smartphones and the widespread use of text messaging , supplemental text-to-speech communication may provide an accessible and cost-effective communication option for patients on vocal restrictions .


To assess anatomical and functional outcomes of a novel laparoscopic vaginoplasty technique using a single peritoneal flap ( SPF ) in patients with Mayer-Rokitansky-Kster-Hauser ( MRKH ) syndrome .


Prospective follow-up study .


University-based tertiary-care hospital .


Patients with MRKH syndrome ( n = @ ) and randomly selected frequency-matched age-comparable healthy women serving as controls ( n = @ ) .


From March @ to March @ , a total of @ patients with MRKH syndrome underwent laparoscopic vaginoplasty using an SPF .


Intraoperative parameters , postoperative parameters , and anatomical outcomes were recorded .


The functional results of patients who became sexually active were assessed using the Female Sexual Function Index ( FSFI ) questionnaire and were compared with those of the controls .


Laparoscopic vaginoplasty using an SPF was successfully performed in all @ patients , with no intraoperative complications .


The mean operative time and intraoperative blood loss were , respectively , @ @ minutes and @ @ ml .


The mean length and width of the neovagina at the @-month follow-up examination were , respectively , @ @ cm and @ @ cm .


Anatomical success was achieved in all patients .


At @months after surgery , functional success , as assessed by the FSFI questionnaire , was achieved in @ % of patients .


The FSFI scores did not differ significantly between patients with MRKH and healthy women in a control group .


Laparoscopic vaginoplasty using an SPF may be a feasible and effective approach that has satisfactory anatomical and functional outcomes for patients with MRKH syndrome .


Failure to achieve treatment targets is common among people with type @ diabetes .


Cost-effective treatments are required to delay the onset and slow the progression of diabetes-related complications .


This study aimed to measure the effect of a @-month telephone coaching intervention on glycaemic control , risk factor status and adherence to diabetes management practices at the intervention 's conclusion ( @ months ) and at @ months .


This randomised controlled trial recruited @ adults with type @ diabetes and an HbA@C > @ % from the Diabetes Clinic of St Vincent 's Hospital Melbourne .


People who were non-English speaking , cognitively impaired , severely hearing impaired or without telephone access were excluded .


Participants were randomised to receive usual care plus @ months of telephone coaching focusing on achieving treatment targets and complication screening , or usual care only .


The primary outcome was HbA@C at @ months ; secondary outcomes included other physiological and monitoring measures .


Significant interaction effects were observed between group and time at @ months , demonstrating improvement in HbA@C , fasting glucose , diastolic blood pressure and physical activity .


The intervention 's effect on these parameters was not sustained at @ months .


Intervention group participants also improved compliance with foot examinations and pneumococcal vaccination by @ months and retinal screening by @ months .


Telephone coaching improved glycaemic control and adherence to complication screening in people with type @ diabetes , for the duration of its delivery , but these effects were not maintained on withdrawal of the intervention .


Strategies that assist patients to sustain these benefits are required .


To compare performance error and perceived difficulty during toe-out gait modification in people with knee osteoarthritis ( OA ) across @ different types of visual feedback : mirror , raw video , and real-time biofeedback of toe-out angle .


Repeated-measures , within-subject trial .


University motion analysis laboratory .


Individuals with knee OA ( N = @ ; @ women ; mean age , @ y ) participated in this study .


Seven participants had mild knee OA , @ had moderate knee OA , and @ had severe knee OA .


Participants were trained to walk on a treadmill while matching a target indicating a @ increase in stance phase toe-out compared with toe-out angle measured during self-selected walking .


The target was provided visually via the @ types of feedback listed above and were presented in a random order .


Kinematic data were collected and used to calculate the difference between the target angle and the actual performed angle for each condition ( toe-out performance error ) .


Difficulty was assessed using a numerical rating scale ( @-@ ) provided verbally by participants .


Toe-out performance error was significantly less when using the real-time biofeedback method than when using the other @ methods ( P = @ ; mean difference vs mirror = @ ; mean difference vs raw video = @ ) .


Perceived difficulty was not statistically different between the groups ( P = @ ) .


Although statistically significant , the @ difference in toe-out gait performance error may not necessitate the large economic and personnel costs of real-time biofeedback as a means to modify movement in clinical or research settings .


The prevalence of male obesity is increasing but few men take part in weight loss programmes .


We assessed the effect of a weight loss and healthy living programme on weight loss in football ( soccer ) fans .


We did a two-group , pragmatic , randomised controlled trial of @ male football fans aged @-@ years with a body-mass index ( BMI ) of @ kg/m ( @ ) or higher from @ Scottish professional football clubs .


Participants were randomly assigned with SAS ( version @ , block size @-@ ) in a @:@ ratio , stratified by club , to a weight loss programme delivered by community coaching staff in @ sessions held every week .


The intervention group started a weight loss programme within @ weeks , and the comparison group were put on a @ month waiting list .


All participants received a weight management booklet .


Primary outcome was mean difference in weight loss between groups at @ months , expressed as absolute weight and a percentage of their baseline weight .


Primary outcome assessment was masked .


Analyses were based on intention to treat .


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


@ men were allocated to the intervention group and @ to the comparison group .


@ ( @ % ) of the intervention group and @ ( @ % ) of the comparison group completed @ month assessments .


At @ months the mean difference in weight loss between groups , adjusted for baseline weight and club , was @ kg ( @ % CI @-@ ) and percentage weight loss , similarly adjusted , was @ % ( @-@ ) , both in favour of the intervention ( p < @ ) .


Eight serious adverse events were reported , five in the intervention group ( lost consciousness due to drugs for pre-existing angina , gallbladder removal , hospital admission with suspected heart attack , ruptured gut , and ruptured Achilles tendon ) and three in the comparison group ( transient ischaemic attack , and two deaths ) .


Of these , two adverse events were reported as related to participation in the programme ( gallbladder removal and ruptured Achilles tendon ) .


The FFIT programme can help a large proportion of men to lose a clinically important amount of weight ; it offers one effective strategy to challenge male obesity .


The objective of this study was to evaluate the long-term safety and efficacy of tabalumab , a monoclonal antibody that neutralizes membrane-bound and soluble B-cell-activating factor , in rheumatoid arthritis ( RA ) patients .


Patients with RA who completed one of two @-week randomized controlled trials ( RCTs ) participated in this @-week , flexible-dose , open-label extension study .


Patients in RCT@ received intravenous placebo , @-mg tabalumab or @-mg tabalumab every @weeks , and patients in RCT@ received subcutaneous placebo or @ - , @ - , @ - , @ - , @ - or @-mg tabalumab every @weeks ( Q@W ) .


Regardless of prior treatment , all patients in this study received subcutaneous @-mg tabalumab Q@W for the first @months , then a one-time increase to @-mg tabalumab Q@W ( @-mg/@-mg group ) and a one-time decrease to @-mg tabalumab Q@W per patient was allowed ( @-mg/@-mg/@-mg group ) .


There were @ patients enrolled : @mg ( n = @ ) , @/@mg ( n = @ ) and @/@/@mg ( n = @ ) .


Pretabalumab baseline disease activity was generally higher in the @-mg/@-mg group .


There was a higher frequency of serious adverse events and treatment-emergent adverse events , as well as infections and injection-site reactions , in the @-mg/@-mg group .


One death unrelated to the study drug occurred ( @-mg/@-mg group ) .


In both groups , total B-cell counts decreased by approximately @ % from the baseline level in the RCT originating study .


Both groups demonstrated efficacy through @weeks of treatment relative to baseline pretabalumab disease activity based on American College of Rheumatology criteria improvement @ % , @ % and @ % ; European League against Rheumatism Responder Index in @ joints ; Disease Activity Score in @ joints-C-reactive protein ; and Health Assessment Questionnaire-Disability Index .


With long-term , open-label tabalumab treatment , no unexpected safety signals were observed , and B-cell reductions were consistent with previous findings .


Despite differences in RCT originating studies , both groups demonstrated an efficacy response through the @-week extension .


Trigeminal nerve block is widely used for trigeminal neuralgia ( TN ) , though with much painful procedure and potential serious complications .


The pain of TN occurs most frequently in the second and the third divisions of the trigeminal nerve , which are distributed in intraoral mucous membrane as well as face skin .


Here , we examined the response to intraoral application of @ % lidocaine ( LDC ) in patients with oral TN pain in a double-blind , placebo ( PBO ) - controlled crossover study .


Twenty-four outpatients with oral TN pain were randomized to receive intraoral application of either @ % LDC or saline PBO to the painful area .


Following @-days period , patients were crossed over to receive the alternative treatment .


The pain was assessed with a numerical rating scale ( NRS ) before and @ minutes after treatment .


Patients used a descriptive scale to grade pain outcome and were asked to note any recurrence and the latency for recurrence after therapy .


Intraoral LDC , but not PBO , significantly decreased the NRS from @ ( @ , @ ) ( median -LSB- @ , @ percentiles -RSB- ) to @ ( @ , @ ) ( P = @ ) .


Of the @ patients , @ described marked or moderate relief of pain after LDC but only three described the same after PBO application .


The effect of LDC and PBO persisted for @ ( @ , @ ) and @ ( @ , @ ) hours , respectively .


Intraoral application of @ % LDC produced prompt analgesia without serious side effects in patients with TN who presented with severe intraoral pain .


Knee osteoarthritis ( OA ) is a common and disabling condition .


Abnormalities in knee loading play an important role in disease pathogenesis , yet there are few non-surgical treatments for knee OA capable of reducing knee load .


This two-arm randomised controlled trial is investigating the efficacy of specially-designed unloading shoes for the treatment of symptoms in people with knee OA .


@ people with symptomatic medial tibiofemoral joint OA will be recruited from the community and randomly allocated to receive either unloading shoes or control shoes .


Unloading shoes have a specially-designed triple-density midsole where the medial side is softer than normal and the lateral side harder as well as a lateral wedge between the sole and sock-liner .


Control shoes are standard athletic shoes and do not contain these features .


Participants will be blinded to shoe allocation and will be instructed to wear the shoes as much as possible every day for @ months , for a minimum of @ hours per day .


The primary outcomes are knee pain ( numerical rating scale ) and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index ) measured at baseline and @ months .


Secondary outcomes include additional measures of knee pain , knee stiffness , participant global ratings of change in symptoms , quality-of-life and physical activity .


The findings from this study will help determine whether specially-designed unloading shoes are efficacious in the management of knee OA .


Tonsillectomy is one of the most common pediatric procedures in the United States .


An optimal perioperative pain control regimen remains a challenge .


Intravenous ibuprofen administered at induction of anesthesia may be a safe and efficacious option for postoperative tonsillectomy pain .


To determine whether preoperative administration of intravenous ibuprofen ( IV-ibuprofen ) can significantly decrease the number of doses of postoperative fentanyl when compared with placebo in pediatric tonsillectomy surgical patients .


This was a multicenter , randomized , double-blind placebo-controlled trial conducted at six hospitals in the United States .


A total of @ pediatric patients aged @-@ years undergoing tonsillectomy were randomized to receive either a single preoperative dose of @ mgkg ( -@ ) IV-ibuprofen or placebo ( normal saline ) .


Postoperative pain was managed with intravenous fentanyl ( @ gkg ( -@ ) ) on an as needed basis when the visual analog scale ( VAS ) was > @ mm and deemed appropriate by recovery room nurse/physician .


The primary endpoint was the number of doses and amount of postoperative fentanyl administered postoperatively for rescue analgesia .


There was a significant reduction in the number of postoperative doses and the amount of fentanyl administered after surgery in the IV-ibuprofen group compared with the placebo group ( P = @ ) .


There were no differences in the time to first analgesia request or the number of patients who required postoperative analgesia .


There were no significant differences in the incidence of serious adverse events , surgical blood loss ( P = @ ) , incidence of postoperative bleeding , or a need for surgical re-exploration between the treatment groups .


Administration of IV-ibuprofen , @ mgkg ( -@ ) , significantly reduced fentanyl use in pediatric tonsillectomy patients .


The objective of this study is to compare the effects of mindfulness-based stress reduction ( MBSR ) versus yoga on urinary urge incontinence ( UI ) at @ weeks , @ months , and @ year after beginning an @-week program .


Participants in this prospective randomized single-masked pilot study were women aged @ years or older with urge-predominant incontinence , @ or more UI episodes ( UIEs ) on a @-day voiding diary , and no recent anticholinergic use .


Women were randomized to MBSR or yoga .


The primary outcome was the percent change of UIE .


Of @ enrollees ( @ in MBSR , @ in yoga ) , @ completed at least @ of @ sessions ( @ in MBSR and @ in yoga ) .


Twenty and @ women completed the @-month and @-month follow-up visits , respectively .


At @ weeks , @ months , and @ months , the median percent change from the baseline in UIE on the intention-to-treat analysis was greater for the MBSR group ( -@ , -@ , and -@ , respectively ) compared with that for the yoga group ( -@ , -@ , and -@ , respectively ) , with P values ranging from @ to @ .


On intention-to-treat analysis , the median percent change in the Overactive Bladder Symptom and Quality of Life-Short Form and the Health-Related Quality of Life was greater at each time point for MBSR than for yoga but was statistically significant only at @ weeks ( P = @ and @ , respectively ) .


As per protocol analysis , at @ weeks , @/@ and @/@ women in MBSR and yoga , respectively , reported they were very much or much better ( P = @ ) , whereas at @ year , @/@ and @/@ women in MBSR and yoga , respectively , did so ( P = @ ) .


These results support larger scale trials to evaluate MBSR , which seems to be a promising treatment of UI .


Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment , experience relapse and readmission to hospital , and sometimes attempt suicide .


The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged .


This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope , reduce loneliness , improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only , with follow-up at one and three-months post-discharge .


A total of @ service users were recruited to the study ; @ receiving peer support and @ in the care-as-usual arm .


While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures , there is an indication that hope may be further increased in those in receipt of peer support .


The total cost per case for the peer support arm of the study was @ compared to @ for the control arm .


The mean difference between costs was minimal and not statistically significant .


However , further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness .


Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support .


The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered ; the length and frequency of support provided ; and the contact between peer supporters and mental health staff .


There is no conclusive evidence to support the cost effectiveness of providing peer support , but neither was it proven a costly intervention to deliver .


The findings support an argument for a larger scale trial of peer support as an adjunct to existing services .


To assess the effectiveness of a telephone-based peer-delivered intervention in reducing distress among women with a BRCA@ or BRCA@ gene mutation .


The intervention involved trained peer volunteers contacting women multiple times over a @-month period to provide informational , emotional , and practical support .


Three hundred thirty-seven participants completed the baseline questionnaire , and those reporting interest in talking to other mutation carriers were randomly assigned to either the usual care group ( UCG ; n = @ ) or the intervention group ( IG ; n = @ ) .


Participants and researchers were not blinded to group allocation .


Two follow-up questionnaires were completed , one at the end of the intervention ( @ months after random assignment , time @ ) and one @ months later ( time @ ) .


Outcomes included breast cancer distress ( primary outcome ) , unmet information needs , cognitive appraisals about mutation testing , and feelings of isolation .


There was a greater decrease in breast cancer distress scores in the IG than UCG at time @ ( mean difference , -@ ; @ % CI , -@ to -@ ; P = @ ) and time @ ( mean difference , -@ ; @ % CI , -@ to -@ ; P = @ ) .


There was a greater reduction in unmet information needs in the IG than UCG ( P < @ ) , with unmet needs being lower in the IG than UCG at time @ .


There was a greater reduction in Cognitive Appraisals About Genetic Testing stress subscale scores in the IG than UCG ( P = @ ) , with significantly lower scores among the IG than UCG at time @ ( P < @ ) .


The intervention is effective in reducing distress and unmet information needs for this group of women .


Identifying strategies for prolonging intervention effects is warranted .


To evaluate the effects of a low-sodium and high-potassium salt-substitute on lowering blood pressure ( BP ) among Tibetans living at high altitude ( @ meters ) .


The study was a patient-blinded randomized controlled trial conducted between February and May @ in Dangxiong County , Tibetan Autonomous Region , China .


A total of @ Tibetans aged @ or older with known hypertension ( systolic BP@ mmHg ) were recruited and randomized to intervention ( salt-substitute , @ % sodium chloride , @ % potassium chloride and @ % magnesium sulfate ) or control ( @ % sodium chloride ) in a @ : @ allocation ratio with three months ' supply .


Primary outcome was defined as the change in BP levels measured from baseline to followed-up with an automated sphygmomanometer .


Per protocol ( PP ) and intention to treat ( ITT ) analyses were conducted .


After the three months ' intervention period , the net reduction in SBP/DBP in the intervention group in comparison to the control group was -@ / -@ mmHg ( all p < @ ) in PP analysis , after adjusting for baseline BP and other variables .


ITT analysis showed the net reduction in SBP/DBP at -@ / -@ mmHg with multiple imputations ( all p < @ ) .


Furthermore , the whole distribution of blood pressure showed an overall decline in SBP/DBP and the proportion of patients with BP under control ( SBP/DBP < @ mmHg ) was significantly higher in salt-substitute group in comparison to the regular salt group ( @ % vs. @ % , p = @ ) .


Low sodium high potassium salt-substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple , low-cost approach for hypertension control among Tibetans in China .


To determine the sensitivity and specificity of the Web-based vision-screening test ( WBT ) VisionForKids.org when administered by an untrained layperson in a controlled environment .


Visual acuities were obtained by an untrained layperson using the WBT under observation and by an ophthalmic professional using the Electronic Visual Acuity ( EVA ) Tester .


Subjects were randomized to which method was used first .


Subjects were considered to have failed by the following criteria : in children < @ months , @/@ vision ; in children between @ and @ months , @/@ or worse ; in children @ months , @/@ or worse .


The results of the vision examinations by the WBT and the EVA Tester were compared ; sensitivity and specificity of the WBT and the correlation coefficient to detect normal and abnormal vision compared to EVA testing were determined .


Visual acuities were obtained on @ children between ages @ and @ years ( average age , @ years ) .


Sensitivity of the WBT was @ % ( @ % CI , @ % -@ % ) , specificity was @ % ( @ % CI , @ % -@ % ) .


The correlation coefficient of EVA testing with the WBT was @ ( P < @ ) .


This layperson-administered WBT , VisionForKids.org , is valid for identifying amblyopia in a controlled environment , making it possible for cost-effective and easily accessible vision screening to be performed by laypersons .


Few studies have examined why smoking cessation interventions are effective .


The aim of this study was to examine the mediating processes underlying the effectiveness of cessation counseling administered by the Dutch national quitline .


Data were used of a two-arm randomized controlled trial in which smoking parents , who were recruited through primary schools in The Netherlands , received either quitline cessation counseling ( n = @ ) or a self-help brochure ( n = @ ) .


The endpoint was @-months prolonged abstinence at @-months follow-up , with @ % outcome data retention .


Putative psychological mediators of treatment effectiveness included smoking-related cognitions ( positive smoking outcome expectancies , self-efficacy ) , emotions ( negative affect , perceived stress , depressive symptoms ) , and smoking cue coping methods ( avoidance coping , acceptance coping ) assessed at @-months post-measurement .


Quitline cessation counseling significantly decreased positive smoking outcome expectancies and negative affect and increased self-efficacy to refrain from smoking , avoidance of external cues to smoking , and acceptance of internal cues to smoking compared to self-help material .


Increased self-efficacy to refrain from smoking in stressful and tempting situations ( p < @ ) and increased acceptance of cravings to smoke ( p < @ ) significantly mediated the effect of quitline cessation counseling on prolonged abstinence at @-months follow-up ( explained variance : @ % ) .


Self-efficacy to refrain from smoking and acceptance of cravings represent an important source of therapeutic change in smoking cessation counseling .


In this Phase @ international study , efficacy and safety of paricalcitol-centred therapy were compared with that of cinacalcet-centred therapy for the treatment of chronic kidney disease ( CKD ) - associated secondary hyperparathyroidism ( SHPT ) in patients undergoing haemodialysis ( ClinicalTrials.gov identifier NCT@ ) .


Patients @ years of age with Stage @ CKD and SHPT -LSB- intact parathyroid hormone ( iPTH ) level of @-@ pg/mL , calcium level of @-@ @ mg/dL and phosphate concentration of @ mg/dL -RSB- who were undergoing haemodialysis were included .


Patients were randomized by mode of paricalcitol administration -LSB- i.e. intravenous ( IV ) or oral strata -RSB- to receive paricalcitol - or cinacalcet-centred therapy for @ weeks .


Changes in metabolic markers -LSB- total alkaline phosphatase ( AP ) , bone-specific AP and fibroblast growth factor-@ ( FGF-@ ) -RSB- and the proportion of patients in each treatment group who achieved an iPTH level of @-@ pg/mL during Weeks @ , @ and @-@ as a composite value were evaluated .


Compared with cinacalcet-centred therapy , levels of both bone turnover markers were significantly reduced from baseline with IV and oral paricalcitol-centred treatment ( P < @ for both dosing strata ) at Weeks @ , @ and @ .


Levels of FGF-@ were increased with paricalcitol versus cinacalcet-centred treatment .


A greater proportion of patients receiving paricalcitol-centred therapy achieved target iPTH levels ( i.e. @-@ pg/mL ) throughout the study in the IV and oral dosing strata compared with patients receiving cinacalcet-centred treatment .


In patients with CKD and SHPT undergoing haemodialysis , paricalcitol-centred therapy reduced circulating bone turnover markers and iPTH levels and increased FGF-@ levels compared with cinacalcet-centred treatment .


The immunological bases for the efficacies of the @ currently licensed influenza vaccines , live attenuated influenza vaccine ( LAIV ) and inactivated influenza vaccine ( IIV ) , are not fully understood .


The goal of this study was to identify specific B-cell responses correlated with the known efficacies of these @ vaccines .


We compared the B-cell and antibody responses after immunization with @/@ IIV or LAIV in young adults , focusing on peripheral plasmablasts @-@ days after vaccination .


The quantities of vaccine-specific plasmablasts and plasmablast-derived polyclonal antibodies ( PPAbs ) in IIV recipients were significantly higher than those in LAIV recipients .


No significant difference was detected in the avidity of vaccine-specific PPAbs between the @ vaccine groups .


Proportionally , LAIV induced a greater vaccine-specific immunoglobulin A plasmablast response , as well as a greater plasmablast response to the conserved influenza nuclear protein , than IIV .


The cross-reactive plasmablast response to heterovariant strains , as indicated by the relative levels of cross-reactive plasmablasts and the cross-reactive PPAb binding reactivity , was also greater in the LAIV group .


Distinct quantitative and qualitative patterns of plasmablast responses were induced by LAIV and IIV in young adults ; a proportionally greater cross-reactive response was induced by LAIV .


This study was designed to investigate whether a priming dose of ketamine-dexmedetomidine can effectively suppress fentanyl-induced coughing ( FIC ) .


Altogether @ patients of ASA I and II , aged @-@ years , undergoing various elective surgical procedures , were randomly allocated into four groups of @ patients each .


Patients in the placebo group received volume-matched normal saline @ mL/kg + normal saline @ mL/kg .


One group of patients was given ketamine @ mg/kg + normal saline @ ml/kg ( KET ) , and another group dexmedetomidine @ g/kg + normal saline @ ml/kg ( DEX ) .


Finally , one group of patients received ketamine @ mg/kg + dexmedetomidine @ g/kg ( KETODEX ) .


After fentanyl administration , the onset time and severity of cough for @ min were recorded .


Cough severity was graded as mild ( grade @-@ ) , moderate ( grade @-@ ) , or severe ( grade > @ ) .


The incidence of FIC was @ % , @ % , @ % , and @ % in the placebo , DEX , KET , and KETODEX groups , respectively .


The incidence of cough was significantly lower in the KETODEX group .


Likewise , the onset time of cough was significantly delayed in the KETODEX group .


Only nine patients in the KETODEX group had either mild ( @ % ) or moderate ( @ % ) cough , with none suffering from severe cough .


A priming dose of KETODEX effectively suppressed the cough reflex induced by fentanyl and delayed the onset time of cough .


Therefore , treatment with KETODEX may be a clinically useful method for preventing FIC .


The provision of quality end-of-life care is increasingly on the national agenda in many countries .


In the United Kingdom , the Gold Standards Framework for Care Homes programme has been promoted as a national framework for improving end-of-life care .


While its implementation is recommended , there are no national guidelines for facilitators to follow to undertake this role .


It was hypothesised that action learning alongside high facilitation when implementing the Gold Standards Framework for Care Homes programme will result in a reduced proportion of hospital deaths for residents and improvement in the care home staff ability to facilitate good end-of-life care .


A cluster randomised controlled trial where @ nursing homes received high facilitation to enable them to implement the Gold Standards Framework for Care Homes programme .


The managers of @ nursing homes additionally took part in action learning sets .


A third group ( @ nursing homes ) received the ` standard ' Gold Standards Framework for Care Homes facilitation available in their locality .


In total , @ nursing homes providing care for frail older people , their deceased residents and their nurse managers .


A greater proportion of residents died in those nursing homes receiving high facilitation and action learning but not significantly so .


There was a significant association between the level of facilitation and nursing homes completing the Gold Standards Framework for Care Homes programme through to accreditation .


Year-on-year change occurred across all outcome measures .


There is a danger that without national guidelines , facilitation of the Gold Standards Framework for Care Homes programme will vary and consequently so will its implementation .


The nurse manager of a care home must be actively engaged when implementing the Gold Standards Framework for Care Homes programme .


The Effect of Cilostazol in Acute Lacunar Infarction Based on Pulsatility Index of the Transcranial Doppler ( ECLIPse ) study showed a significant decrease in the transcranial Doppler ( TCD ) pulsatility index ( PI ) with cilostazol treatment at @ days after acute lacunar infarction .


The aim of the present study was to perform a subgroup analysis of the ECLIPse study in order to explore the effect of cilostazol in acute lacunar infarction based on cerebral white matter hyperintensities ( WMH ) volume .


The ECLIPse study was a multicenter , randomized , double-blind , placebo-controlled trial that evaluated the difference between the efficacy of cilostazol and a placebo to reduce the PI in patients with acute lacunar infarction using serial TCD examinations .


The primary outcome was changes in the PIs of the middle cerebral artery ( MCA ) and basilar artery at @ and @ days from the baseline TCD study .


For this subgroup analysis , using semi-automated computerized software , the WMH volume was measured for those subjects for whom fluid-attenuated inversion recovery ( FLAIR ) images were available .


Of the @ patients in eight hospitals in the ECLIPse study , @ participants from six hospitals were included in this subgroup analysis .


Cilostazol was given to @ patients ( @ % ) and placebo to @ patients ( @ % ) .


All baseline characteristics were well balanced across the two groups , and there were no significant differences in these characteristics except in the changes of PI from the baseline to the @-day point .


There was a significant decrease of TCD PIs at @-day study from baseline in the cilostazol group ( p = @ ) .


The mean WMH volume was @ cm ( @ ) ( @-@ @ , median @ ) and the mean MCA PI was @ ( @-@ @ ) .


The changes in PIs from the baseline to @ days and to @ days were @ ( -@ to @ ) and @ ( -@ to @ ) .


While there were no significant correlations between WMH volume and the changes in PIs , a trend of inverse correlation was observed between the WMH volume and the changes in PIs from the baseline to the @-day point .


For the subgroup analysis , the WMH volume was dichotomized based on its median value ( @ cm ( @ ) ) .


Cilostazol decreased the TCD PIs significantly at the @-day point in patients with WMH volumes @ cm ( @ ) ( p = @ ) .


Significant treatment effects were observed in the cilostazol group .


This study showed that cilostazol decreased cerebral arterial pulsatility in patients with WMH .


Our findings indicate the unique effect of cilostazol in small vessel disease ( SVD ) , especially in patients with mild WMH changes .


Further clinical trials focusing on WMH volume and clinical outcomes are required to assess the unique efficacy of cilostazol in SVD .


to examine the costs and cost-effectiveness of ` second-generation ' telecare , in addition to standard support and care that could include ` first-generation ' forms of telecare , compared with standard support and care that could include ` first-generation ' forms of telecare .


a pragmatic cluster-randomised controlled trial with nested economic evaluation .


A total of @,@ people with social care needs participated in a trial of community-based telecare in three English local authority areas .


In the Whole Systems Demonstrator Telecare Questionnaire Study , @ participants were randomised to intervention and @ to control .


Participants who were offered the telecare intervention received a package of equipment and monitoring services for @ months , additional to their standard health and social care services .


The control group received usual health and social care .


incremental cost per quality-adjusted life year ( QALY ) gained .


The analyses took a health and social care perspective .


cost per additional QALY was @,@ .


Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of @,@ per QALY gained was only @ % .


Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of @,@ per QALY .


while QALY gain in the intervention group was similar to that for controls , social and health services costs were higher .


Second-generation telecare did not appear to be a cost-effective addition to usual care , assuming a commonly accepted willingness to pay for QALYs .


According to a recent survey , the @ North American Society for Pediatric Gastroenterology , Hepatology , and Nutrition-European Society for Pediatric Gastroenterology , Hepatology , and Nutrition gastroesophageal reflux guidelines are poorly adhered to by European primary care pediatricians .


The main issue raised from the survey was the prescription of unnecessary acid suppressive medications , especially in infants .


No inquiry into the reasons was made .


The primary objective of the present study was to assess the applicability of the guidelines in European primary care pediatricians undergoing specific trainings .


One hundred pediatricians involved in the previous survey agreed to participate and were randomly divided into @ groups : one group was trained in the guidelines through an online podcast and the other group was trained through a synopsis .


During the following @ months , each involved pediatrician was asked to enroll every consecutive infant , child , or adolescent with suggestive reflux symptoms .


For every enrolled patient , pediatricians filled in a report concerning their diagnostic and therapeutic choices .


A total of @ patients ( boys/girls @/@ , infants/children/adolescents @/@/@ ) were enrolled by pediatricians .


Infants with unexplained crying and/or distressed behavior who were prescribed proton-pump inhibitors were @ % compared with @ % of the survey data obtained before the training ( P < @ ) .


Infants with uncomplicated recurrent regurgitation and vomiting who were prescribed proton-pump inhibitors were @ % against @ % of the baseline survey data ( P < @ ) .


The overall rate of children managed in full compliance with the guidelines was @ % after the training compared with @ % before the training ( P < @ ) .


No significant differences were seen between pediatricians from podcast and synopsis group .


The North American Society for Pediatric Gastroenterology , Hepatology , and Nutrition-European Society for Pediatric Gastroenterology , Hepatology , and Nutrition gastroesophageal reflux guidelines have good applicability , despite that they are presently poorly adhered to by European primary care pediatricians .


Simple , inexpensive trainings were proven to be effective in increasing adherence by pediatricians .


The increase in compliance clearly favors the role of continuous medical education through simple educational tools and subsequent assessment of practice .


Safety of individual probiotic strains approved under Investigational New Drug ( IND ) policies in cirrhosis with minimal hepatic encephalopathy ( MHE ) is not clear .


The primary aim of this phase I study was to evaluate the safety , tolerability of probiotic Lactobacillus GG ( LGG ) compared to placebo , while secondary ones were to explore its mechanism of action using cognitive , microbiome , metabolome and endotoxin analysis in MHE patients .


Cirrhotic patients with MHE patients were randomised @:@ into LGG or placebo BID after being prescribed a standard diet and multi-vitamin regimen and were followed up for @ weeks .


Serum , urine and stool samples were collected at baseline and study end .


Safety was assessed at Weeks @ and @ .


Endotoxin and systemic inflammation , microbiome using multi-tagged pyrosequencing , serum/urine metabolome were analysed between groups using correlation networks .


Thirty MHE patients ( @ LGG and @ placebo ) completed the study without any differences in serious adverse events .


However , self-limited diarrhoea was more frequent in LGG patients .


A standard diet was maintained and LGG batches were comparable throughout .


Only in the LGG-randomised group , endotoxemia and TNF - decreased , microbiome changed ( reduced Enterobacteriaceae and increased Clostridiales Incertae Sedis XIV and Lachnospiraceae relative abundance ) with changes in metabolite/microbiome correlations pertaining to amino acid , vitamin and secondary BA metabolism .


No change in cognition was found .


In this phase I study , Lactobacillus GG is safe and well-tolerated in cirrhosis and is associated with a reduction in endotoxemia and dysbiosis .


Heart failure ( HF ) carries poor prognosis in coronary artery disease ( CAD ) patients despite advances in therapy .


Inflammation predicts recurrent cardiovascular events in CAD patients .


It is unknown whether increased levels of inflammatory markers are associated with incident HF in these patients .


The aims of this study were to evaluate the association between inflammatory markers and future HF risk in patients with stable CAD and to explore possible mediation by myocardial infarction ( MI ) .


The study comprised @,@ patients with stable CAD without HF at baseline during a median follow-up of @ years .


Inflammatory baseline markers were the basis of this study .


Heart failure was diagnosed in @ patients ( @ % ) .


Patients who developed HF were older and had more often previous MI , diabetes , hypertension , and peripheral vascular disease .


Baseline levels of C-reactive protein ( CRP ) , fibrinogen , and white blood cells ( WBCs ) were significantly higher in patients who developed HF compared with those who did not .


Age-adjusted incident HF rates were related to elevated baseline inflammatory markers in a dose-response manner .


Adjusting for multiple confounders , the HF hazard ratios were @ ( @ % CI @-@ @ ) , @ ( @ % CI @-@ @ ) , and @ ( @ % CI @-@ @ ) for the third tertiles of CRP , fibrinogen , and WBC levels , respectively .


Hazard ratio for the fifth quintile of a combined `` inflammation score '' was @ ( @ % CI @-@ @ ) .


Mediation by MI preceding the HF onset during follow-up accounted for @ % , @ % , and @ % of the association of subsequent HF with CRP , fibrinogen , and WBC , respectively .


Increased levels of CRP , fibrinogen , and WBC are independently related to the incidence of HF in patients with stable CAD .


There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer ( CRC ) .


A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease .


We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival .


The CAIRO@ study is a multicentre , randomized , phase III study of the Dutch Colorectal Cancer Group ( DCCG ) .


Patients with synchronous unresectable metastases of CRC and few or absent symptoms of the primary tumour are randomized @:@ between systemic therapy only , and resection of the primary tumour followed by systemic therapy .


Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab .


The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour .


Secondary endpoints include progression free survival , surgical morbidity , quality of life and the number of patients requiring resection of the primary tumour in the control arm .


The CAIRO@ study is a multicentre , randomized , phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC .


Despite extensive research on gender differences in addiction , there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials .


An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence ( N = @ ) was evaluated for gender differences in clinical outcomes .


Secondary analyses compared gender differences in outcome by medication condition ( disulfiram versus no medication ) and across multiple behavioral treatment conditions .


Women , compared with men , had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up .


These results appear to be primarily accounted for by disulfiram being less effective in women compared with men .


There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated .


These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction .


Conversely , some addiction pharmacotherapies , such as disulfiram , may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation .


The aim of this work was to evaluate the effect of high-intensity interval exercise ( i.e. , @s at @ % of max workload , followed by @s at rest , @ min @ days/week working-out schedule for @ weeks ) on left ventricular function and aortic elastic properties among chronic heart failure ( CHF ) patients .


This study is a phase III clinical trial .


Of the @ consecutive CHF patients ( NYHA classes II-IV , ejection fraction < @ % ) that were randomly allocated , @ completed the study ( exercise training group , n = @ , @ @ years , @ % men , and control group , n = @ , @ @ years , @ % men ) .


All patients underwent cardiopulmonary stress test , non-invasive high-fidelity tonometry of the radial artery , pulse wave velocity measurement using a SphygmoCor device and echocardiography before and after the completion of the training program .


Both groups reported similar medical characteristics and physical activity status .


General mixed effects models revealed that the intervention group reduced pulse wave velocity by @ % ( p = @ ) ; Emv/Vp by @ % ( p = @ ) ; E to A ratio by @ % ( p = @ ) , E to Emv ratio by @ % ( p = @ ) , MLHFQ score by @ % ( p = @ ) and the depression score by @ % ( p = @ ) ; increased augmentation index by @ % ; VTI by @ % ( p = @ ) , @-minute-walk distance up to @ % ( p = @ ) , peak oxygen uptake by @ % ( p = @ ) and peak power by @ % ( p = @ ) .


There were no significant changes in the control group .


Interval high-intensity aerobic training , combined with strength exercise , seems to benefit aortic dilatation capacity and augmented systolic pressure in parallel with improvement in left ventricular diastolic function and quality of life .


To conduct two economic analyses addressing whether to : routinely monitor HIV-infected children on antiretroviral therapy ( ART ) clinically or with laboratory tests ; continue or stop cotrimoxazole prophylaxis when children become stabilized on ART .


The ARROW randomized trial investigated alternative strategies to deliver paediatric ART and cotrimoxazole prophylaxis in @ Ugandan/Zimbabwean children .


Incremental cost-effectiveness and value of implementation analyses were undertaken .


Scenario analyses investigated whether laboratory monitoring ( CD@ tests for efficacy monitoring ; haematology/biochemistry for toxicity ) could be tailored and targeted to be delivered cost-effectively .


Cotrimoxazole use was examined in malaria-endemic and non-endemic settings .


Using all trial data , clinical monitoring delivered similar health outcomes to routine laboratory monitoring , but at a reduced cost , so was cost-effective .


Continuing cotrimoxazole improved health outcomes at reduced costs .


Restricting routine CD@ monitoring to after @ weeks following ART initiation and removing toxicity testing was associated with an incremental cost-effectiveness ratio of $ @ per quality-adjusted life-year ( QALY ) across all age groups , but was much lower for older children ( @ + years at initiation ; incremental cost-effectiveness ratio = $ @/QALY ) .


Committing resources to improve cotrimoxazole implementation appears cost-effective .


A healthcare system that could pay $ @/QALY should be willing to spend up to $ @ per patient-year to ensure continued provision of cotrimoxazole .


Clinically driven monitoring of ART is cost-effective in most circumstances .


Routine laboratory monitoring is generally not cost-effective at current prices , except possibly CD@ testing amongst adolescents initiating ART .


Committing resources to ensure continued provision of cotrimoxazole in health facilities is more likely to represent an efficient use of resources .


The SHIVA trial is a multicentric randomised proof-of-concept phase II trial comparing molecularly targeted therapy based on tumour molecular profiling vs conventional therapy in patients with any type of refractory cancer .


RESULTS of the feasibility study on the first @ enrolled patients are presented .


Adult patients with any type of metastatic cancer who failed standard therapy were eligible for the study .


The molecular profile was performed on a mandatory biopsy , and included mutations and gene copy number alteration analyses using high-throughput technologies , as well as the determination of oestrogen , progesterone , and androgen receptors by immunohistochemistry ( IHC ) .


Biopsy was safely performed in @ of the first @ included patients .


Median time between the biopsy and the therapeutic decision taken during a weekly molecular biology board was @ days .


Mutations , gene copy number alterations , and IHC analyses were successful in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients , respectively .


A druggable molecular abnormality was present in @ patients ( @ % ) .


The establishment of a comprehensive tumour molecular profile was safe , feasible , and compatible with clinical practice in refractory cancer patients .


Aromatase inhibitors are used off-label to treat short stature in peripubertal boys .


To investigate short - and long-term hormonal and auxologic differences in short pubertal boys treated with letrozole ( L ) or anastrozole ( A ) .


PATIENTS are seen for laboratory evaluation and physical examination every @ months , bone age yearly , DEXA and spine film every @ years .


They will be followed until they reach their final height .


This is a preliminary report after @ year of treatment .


A single academic children 's hospital outpatient clinic .


Boys with age > @ years , bone age @ years , clinical and hormonal evidence of central puberty , and either height < fifth percentile or predicted adult height ( PAH ) more than @ cm below mid-parental height ( MPH ) .


Letrozole ( @ mg ) or anastrozole ( @ mg ) was administered orally each day .


Hormonal and clinical parameters , growth velocity , and change in bone age and PAH .


Thirty-nine boys have completed @ year of treatment .


Baseline means were age @ years , PAH @ cm , and testosterone @ ng/dL .


At @ year , letrozole resulted in higher LH ( L @ @ vs A @ @ IU/L ) and testosterone ( @ @ vs @ @ ng/dL ) with lower estradiol ( @ @ vs @ @ pg/mL ) and IGF-@ ( @ @ vs @ @ ng/mL ) .


First year growth velocities were identical ( @ cm/year ) , but an increase in PAH was greater in the anastrozole group ( @ @ vs @ @ cm , p = @ ) after @ year .


We present first-year data from a direct comparison of anastrozole and letrozole for height augmentation in short pubertal boys .


Letrozole was more potent in hormonal manipulation than anastrozole .


First-year growth velocities were comparable , but improvement in PAH was greater in the anastrozole group .


It remains to be seen if positive PAH trends will translate to increase in final height in either group .


PEARLS , a large scale trial of antiretroviral therapy ( ART ) for HIV ( n = @,@ , @ countries , @ continents ) , found that a once-daily protease inhibitor ( PI ) based regimen ( ATV+DDI+FTC ) , but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor ( NNRTI/NRTI ) regimen ( EFV+FTC / TDF ) , had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen ( EFV +@ TC/ZDV ) .


The present study examined non-adherence in PEARLS .


Outcomes : non-adherence assessed by pill count and by self-report , and time to treatment failure .


Longitudinal predictors : regimen , quality of life ( general health perceptions = QOL-health , mental health = QOL-mental health ) , social support , substance use , binge drinking , and sexual behaviors .


`` Life-Steps '' adherence counseling was provided .


In both pill-count and self-report multivariable models , both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen ; although these associations attenuated with time in the self-report model .


In both multivariable models , hard-drug use was associated with non-adherence , living in Africa and better QOL-health were associated with less non-adherence .


According to pill-count , unprotected sex was associated with non-adherence .


According to self-report , soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence .


Both pill-count ( HR = @ , @ % CI : @ , @ , p < @ ) and self-report ( HR = @ , @ % CI : @ , @ , p < @ ) non-adherence were significant predictors of treatment failure over @ weeks .


In multivariable models ( including pill-count or self-report nonadherence ) , worse QOL-health , age group ( younger ) , and region were also significant predictors of treatment failure .


In the context of a large , multi-national , multi-continent , clinical trial there were variations in adherence over time , with more simplified regimens generally being associated with better adherence .


Additionally , variables such as QOL-health , regimen , drug-use , and region play a role .


Self-report and pill-count adherence , as well as additional psychosocial variables , such QOL-health , age , and region , were , in turn , associated with treatment failure .


Therapeutic adherence of patients with chronic obstructive pulmonary disease ( COPD ) is poor .


This study evaluated the effectiveness of a multifactorial intervention on improving the therapeutic adherence in chronic obstructive pulmonary disease ( COPD ) patients with scheduled inhalation therapy .


The study design consisted of a randomised controlled trial in a primary care setting .


@ patients diagnosed with COPD were randomly allocated into two groups using the block randomisation technique .


One-year follow-ups with three visits were performed .


The intervention consisted of motivational aspects related to adherence ( beliefs and behaviour ) in the form of group and individual interviews , cognitive aspects in the form of information about the illness and skills in the form of training in inhalation techniques .


Cognitive-emotional aspects and training in inhalation techniques were reinforced during all visits of the intervention group .


The main outcome measure was adherence to the medication regimen .


Therapeutic adherence was determined by the percentage of patients classified as good adherent as evaluated by dose or pill count .


Of the @ participants ( mean age @ years , @ % males ) , @ % reported adherence ( @ % of the control group and @ % of the intervention group ) .


When multifactorial intervention was applied , the reported adherence was @ % for the control group and @ % for the intervention group , which showed a statistically significant difference ( p = @ ) .


Number needed to treat is @ .


In the intervention group , cognitive aspects increased by @ % and skilled performance of inhalation techniques increased by @ % .


The factors related to adherence when multifactorial intervention was applied were the number of exacerbations ( OR = @ ) , visits to health centre ( OR = @ ) and devices ( OR = @ ) ; illness severity ( OR = @ ) , beta-@-adrenergic ( OR = @ ) and xantine ( OR = @ ) treatment ; activity ( OR = @ ) and impact ( OR = @ ) scales of the Saint George Respiratory Questionnaire .


Application of the multifactorial intervention designed for this study ( COPD information , dose reminders , audio-visual material , motivational aspects and training in inhalation techniques ) resulted in an improvement in therapeutic adherence in COPD patients with scheduled inhalation therapy .


To assess the bacterial contamination risk in cataract surgery associated with mechanical compression of the lid margin immediately after sterilization of the ocular surface .


Department of Cataract , Zhongshan Ophthalmic Center , Sun Yat-sen University , Guangzhou , China .


Prospective randomized controlled double-masked trial .


Patients with age-related cataract were randomly assigned to @ of @ groups .


In Group A ( @ eyes ) , the lid margin was compressed and scrubbed for @ degrees @ times with a dry sterile cotton-tipped applicator immediately after ocular sterilization and before povidone-iodine irrigation of the conjunctival sac .


Group B ( @ eyes ) had identical sterilization but no lid scrubbing .


Samples from the lid margin , liquid in the collecting bag , and aqueous humor were collected for bacterial culture .


Primary outcome measures included the rate of positive bacterial culture for the above samples .


The species of bacteria isolated were recorded .


Group A and Group B each comprised @ eyes .


The positive rate of lid margin cultures was @ % .


The positive rate of cultures for liquid in the collecting bag was significantly higher in Group A ( @ % ) than in Group B ( @ % ) ( P = @ ) .


The bacterial species cultured from the collecting bag in Group B were the same as those from the lid margin in Group A.


The positive culture rate of aqueous humor in both groups was @ % .


Mechanical compression of the lid margin immediately before and during cataract surgery increased the risk for bacterial contamination of the surgical field , perhaps due to secretions from the lid margin glands .


To evaluate the physiologic and psychological effects of an equine-assisted therapy protocol ( EAT ) in breast cancer survivors .


Twenty women ( mean age , @ years ) whose breast cancer treatment had concluded at least @ months previously underwent a screening protocol to certify their eligibility to participate in noncompetitive sports .


The patients were randomly assigned to an intervention group ( n = @ ) or a control group ( n = @ ) .


Intervention patients participated in a @-week EAT protocol consisting of @ hours of activity per week .


All patients were tested before and after the intervention for maximal oxygen consumption ( VO@max ) , fat mass percentage , total body water percentage , strength of principal muscular groups ( measured on five weight-lifting machines -LSB- leg press , leg extension , leg curl , shoulder press , vertical traction -RSB- ) , and quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire ( FACIT-F ) .


After intervention , the intervention group showed an improvement in VO@max ( @ % ; p < @ ) , a decrease in fat mass percentage ( change , -@ % ; p < @ ) , an increase in total body water percentage ( @ % ; p = @ ) , and an increase in strength ( leg press , @ % -LSB- p = @ -RSB- ; leg extension , @ % -LSB- p = @ -RSB- ; leg curl , @ % -LSB- p < @ -RSB- ; shoulder press , @ % -LSB- p = @ -RSB- ; vertical traction , @ % -LSB- p = @ -RSB- ) .


Furthermore , the increase in the three FACIT-F scores ( FACIT-F trial outcome : @ % -LSB- p = @ -RSB- ; Functional Assessment of Cancer Therapy-General total score , @ % -LSB- p = @ -RSB- ; FACIT-F total score , @ % -LSB- p = @ -RSB- ) showed an increase in quality of life .


No significant changes for any variable were found for the control group .


EAT had positive effects on both physiologic and psychological measures , enhancing quality of life of breast cancer survivors .


RESULTS suggest a new method for rehabilitation intervention strategies after cancer in a nonmedical environment .


In our study we aimed to investigate the effect of bupivacaine and levobupivacaine on QT , corrected QT ( QTc ) , and P wave dispersion durations during spinal anesthesia in cesarean section .


Sixty parturients scheduled for elective cesarean section in ASA I-II risk groups were included in the study .


Baseline electrocardiographic ( ECG ) records of the patients were obtained in the operation room .


Heart rate ( HR ) , non-invasive blood pressure ( NIBP ) , peripheral oxygen saturation ( SpO@ ) and respiration rates ( RR ) were recorded .


Venous cannulation was performed with @G cannula and fluid preload made with @ mL.kg ( -@ ) .


Lactated Ringer solution .


After fluid preload , second ECG recordings were taken and the patients were randomly separated into two groups .


Group B ( n = @ ) received @mg of bupivacaine and Group L ( n = @ ) received @mg of levobupivacaine for spinal anesthesia .


ECG recordings were repeated at @ , @ and @ minutes after spinal block .


HR , NIBP , SpO@ , RR and sensory block levels were also recorded at the same time intervals .


At predetermined time intervals of spinal anesthesia , P wave dispersion ( Pwd ) , QT dispersion ( QTd ) , and QTc dispersion ( QTcd ) durations were measured from ECG records .


QT and QTc durations are calculated with Bazzett formula .


There was no difference between two groups according to block levels , hemodynamic parameters , Pwd , QTd , QTc and QTcd durations .


Bupivacaine and levobupivacaine may be preferred in spinal anesthesia in pregnant patients who have extended Pwd and QTcd preoperatively .


To compare radiation exposure and image quality in children undergoing torso helical acquisition computed tomography ( CT ) using filtered back projection ( FBP ) or adaptive iterative dose reduction ( AIDR ) @D reconstruction algorithms .


A secondary purpose is to compare radiation exposure and image quality in children undergoing torso CT acquired with helical or wide-detector techniques reconstructed with AIDR @D .


The study was approved by the institutional review board .


Phase @ included @ helical torso CT studies : @ using FBP and @ using AIDR @D .


The size-specific dose estimate ( SSDE ) was calculated for each study .


Region of interest ( ROI ) noise measurements were recorded in the thorax , abdomen , and pelvis for each study .


Unpaired t tests compared SSDE and image noise for each group .


Phase @ included @ wide-detector CT torso studies using AIDR @D .


Size-specific dose estimate and ROI noise measurements were calculated .


Unpaired t tests compared helical and wide-detector SSDE and ROI .


Additional t tests looked for age - and weight-specific differences in the helical and wide-detector groups .


Phase @ : AIDR @D showed significant reduction in SSDE ( P = @ ) and significant improvement in image quality .


Phase @ : no significant difference in SSDE was observed .


Children younger than @ years had a significant reduction in SSDE with wide-detector technique ( P = @ ) with no loss in image quality .


Adaptive iterative dose reduction @D produces significant reduction in radiation dose without degradation to image quality compared with FBP .


Significant dose reduction without loss of image quality can also be obtained in younger , smaller children using wide-detector technique .


The patients who underwent septoplasty with bilateral totally occlusive nasal packing had an increased risk of experiencing respiratory distress ( RD ) .


To compare the immediate RD rates during recovery from anesthesia and surgical complications of totally occlusive nasal pack , internal nasal splint , and transseptal suture technique .


A total of @ patients were assigned to one of three groups according to the technique utilized following septoplasty : transseptal suturing , internal nasal splint , or Merocel ( nasal dressing without airway ) .


To determine RD related to anesthesia in the operating theatre , the criterion was defined as any unanticipated hypoxemia , hypoventilation or upper airway obstruction ( stridor or laryngospasm ) requiring an active and specific intervention .


Postoperative hemorrhage , infection , synechia formation , and septal perforation were evaluated .


Patients in the Merocel group were @ times more likely to have RD than patients in the transseptal suture and internal nasal splint groups .


Also , patients who smoked had an increased risk of RD during the recovery phase of anesthesia after the septoplasty .


In addition , all three techniques resulted in similar complication rates after septoplasty , with the exception of minor hemorrhage , which had a significantly higher rate in the transseptal suture group .


Pre-emptive intravenous lidocaine infusion is known to improve postoperative pain in abdominal surgery .


We assessed the effect of intravenous lidocaine infusion in patients who underwent subtotal gastrectomy .


We conducted a double-blind , placebo-controlled study with patients undergoing subtotal gastrectomy for early gastric cancer divided into @ groups : @ group received intravenous lidocaine infusion preoperatively and throughout surgery , and the other received normal saline infusion ( placebo ) .


We assessed postoperative outcomes , including pain scores on a visual analogue scale ( VAS ) , administration frequency of patient-controlled analgesia ( PCA ) and the amount of consumed fentanyl .


Postoperative nausea and vomiting , length of hospital stay ( LOS ) , time to return to regular diet and patient satisfaction at discharge were evaluated .


There were @ patients in our study .


Demographic characteristics were similar between the groups .


The VAS pain scores and administration frequency of PCA were significantly lower in the lidocaine group until @ hours after surgery , and fentanyl consumption was significantly lower in this group until @ hours postoperatively compared with the placebo group .


The total amount of consumed fentanyl and the total administration frequency of PCA were significantly lower in the lidocaine than the control group .


No significant differences were detected in terms of nausea and vomiting , return to regular diet , LOS and patient satisfaction , and there were no reported side-effects of lidocaine .


Intravenous lidocaine infusion reduces pain during the postoperative period after subtotal gastrectomy .


Blood conservation using autologous platelet-rich plasma ( aPRP ) , a technique of whole blood harvest that separates red blood cells from plasma and platelets before cardiopulmonary bypass with retransfusion of the preserved platelets after completion of cardiopulmonary bypass , has not been studied extensively .


We sought to prospectively determine whether aPRP reduces blood transfusions during ascending and transverse aortic arch repair .


We randomly assigned @ patients undergoing elective ascending and transverse aortic arch repair using deep hypothermic circulatory arrest to receive either aPRP ( n = @ ) or no aPRP ( n = @ ) .


Volume of aPRP retransfused was @ @ mL .


The primary end point was transfusion amount .


Secondary end points were death , stroke , renal failure , pulmonary failure , and transfusion costs .


Perioperative transfusion rate was defined as blood transfusions given during surgery and up to @ hours afterward .


The surgeon and intensivist were blinded to the treatment arm .


Because an anesthesiologist initiated the protocol , the surgeon was not aware of aPRP collection , as this occurred only after the sterile drape was in place .


In addition , because cell salvage was performed on all cases , differentiation in perfusionist activities ( during spinning of aPRP ) was not evident .


Platelet , fresh frozen plasma , and cryoprecipitate intraoperative transfusions were performed only after heparin was reversed and the patient was judged as coagulopathic on the basis of associated criteria : cryoprecipitate transfusion for fibrinogen level less than @ g/dL , platelet transfusion for platelet count less than @,@ , and fresh frozen plasma when thromboelastogram test was suggestive or a partial thromboplastin time was greater than @ seconds , and prothrombin time was greater than @ seconds .


Early mortality , stroke , and respiratory complications were similar between groups .


Only acute renal failure was reduced in the aPRP group , @ % versus @ % ( p < @ ) .


Mean transfusion rate of packed red blood cells was reduced by @ % , fresh frozen plasma by @ % , cryoprecipitate by @ % , and platelets by @ % in the aPRP group ( p < @ ) .


Hospital length of stay ( @ @ days versus @ @ days ; p < @ ) and transfusion costs ( $ @,@ $ @,@ versus $ @,@ $ @,@ ; p < @ ) were reduced in the aPRP group .


The use of aPRP reduced allogeneic transfusions during ascending and transverse aortic arch repair with deep hypothermic circulatory arrest .


This translated to less acute renal failure , decreased length of stay , and lower transfusion costs .


Further studies examining the coagulation factors of aPRP are required .


Despite @ to % of persons living with HIV in sub-Saharan Africa having clinical depression , and the consequences of depression for key public health outcomes ( HIV treatment adherence and condom use ) , depression treatment is rarely integrated into HIV care programs .


Task-shifting , protocolized approaches to depression care have been used to overcome severe shortages of mental health specialists in developing countries , but not in sub-Saharan Africa and not with HIV clients .


The aims of this trial are to evaluate the implementation outcomes and cost-effectiveness of a task-shifting , protocolized model of antidepressant care for HIV clinics in Uganda .


INDEPTH-Uganda is a cluster randomized controlled trial that compares two task-shifting models of depression care -- a protocolized model versus a model that relies on the clinical acumen of trained providers to provide depression care in ten public health HIV clinics in Uganda .


In addition to data abstracted from routine data collection mechanisms and supervision logs , survey data will be collected from patient and provider longitudinal cohorts ; at each site , a random sample of @ medically stable patients who are depressed according to the PHQ-@ screening will be followed for @ months , and providers involved in depression care implementation will be followed over @ months .


These data will be used to assess whether the two models differ on implementation outcomes ( proportion screened , diagnosed , treated ; provider fidelity to model of care ) , provider adoption of treatment care knowledge and practices , and depression alleviation .


A cost-effectiveness analysis will be conducted to compare the relative use of resources by each model .


If effective and resource-efficient , the task-shifting , protocolized model will provide an approach to building the capacity for sustainable integration of depression treatment in HIV care settings across sub-Saharan Africa and improving key public health outcomes .


Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women .


We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease .


Between Feb @ , @ , and Jan @ , @ , we recruited postmenopausal women aged @-@ years from @ countries into an international , double-blind , randomised placebo-controlled trial .


To be eligible , women had to be at increased risk of breast cancer ( judged on the basis of specific criteria ) .


Eligible women were randomly assigned ( @:@ ) by central computer allocation to receive @ mg oral anastrozole or matching placebo every day for @ years .


Randomisation was stratified by country and was done with blocks ( size six , eight , or ten ) .


All trial personnel , participants , and clinicians were masked to treatment allocation ; only the trial statistician was unmasked .


The primary endpoint was histologically confirmed breast cancer ( invasive cancers or non-invasive ductal carcinoma in situ ) .


Analyses were done by intention to treat .


This trial is registered , number ISRCTN@ .


@ women were randomly assigned to receive anastrozole and @ to placebo .


After a median follow-up of @ years ( IQR @-@ ) , @ women in the anastrozole group ( @ % ) and @ in the placebo group ( @ % ) had developed breast cancer ( hazard ratio @ , @ % CI @-@ , p < @ ) .


The predicted cumulative incidence of all breast cancers after @ years was @ % in the placebo group and @ % in the anastrozole group .


@ deaths were reported in the anastrozole group and @ in the placebo group , and no specific causes were more common in one group than the other ( p = @ ) .


Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women .


This finding , along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment , provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer .


To determine if risk stratification followed by rapid geriatric screening in an emergency department ( ED ) reduced functional decline , ED reattendance and hospitalisation .


This was a quasi-randomised controlled trial .


Patients were randomised by the last digit of their national registration identity card ( NRIC ) .


Odd number controls received standard ED care ; even number patients received geriatric screening , followed by intervention and/or onward referrals .


Patients were followed up for @months .


There were @ and @ patients in the control and intervention groups .


The intervention group had higher Triage Risk Screening Tool ( TRST ) scores ( @ % vs @ % TRST @ , p = @ ) and lower baseline Instrumental Activity of Daily Living ( IADL ) scores ( @ vs @ , p < @ ) .


@ % of the intervention group had unmet needs ; @ % accepted our interventions .


Common positive findings were fall risk ( @ % ) , vision ( @ % ) , and footwear ( @ % ) .


@ % were referred to a geriatric clinic and @ % were admitted .


@ ( @ % ) controls and @ ( @ % ) in the intervention group completed their follow-up .


After adjusting for TRST and baseline IADL , the intervention group had significant preservation in function ( Basic ADL -@ vs -@ , p < @ ; IADL -@ vs +@ , p < @ ) at @months .


The reduction in ED reattendance ( OR@ @ , CI @-@ @ , p = @ ) and hospitalization ( OR@ @ , CI@-@ @ , p = @ ) were not significant , however the real difference would have been wider as @ % of the control group received geriatric screening at the request of the ED doctor .


A major limitation was that a large proportion of patients who were randomized to the intervention group either refused ( @ % ) or left the ED before being approached ( @ % ) .


These two groups were not followed up , and hence were excluded in our analysis .


Risk stratification and focused geriatric screening in ED resulted in significant preservation of patients ' function at @months .


Mammographic density is a strong risk factor for breast cancer and is highly variable , but , to date , few studies have examined density in Asian women , particularly those in low and middle-income Asian countries where genetic and lifestyle determinants may be significantly different .


A total of @,@ women who attended an opportunistic mammogram screening programme were eligible for analysis .


Mammographic density was estimated using a fully-automated thresholding method and differences across ethnic groups were examined using linear regression in @ randomly selected Chinese women , @ Malay and @ Indian women .


Percent density was significantly higher in Chinese women ( @ % ; @ % CI @ % , @ % ) compared to Malay ( @ % ; @ % CI @ % , @ % ) and Indian ( @ % ; @ % CI @ % , @ % ) women ( p < @ ) , after adjustment for age , BMI , menopausal status , parity and age at first full term pregnancy .


Correspondingly , adjusted nondense area was significantly lower in Chinese ( @ cm@ ; @ % CI @ cm@ , @ cm@ ) women compared to Malay ( @ cm@ ; @ % CI @ cm@ , @ cm@ ) and Indian ( @ cm@ ; @ % CI @ cm@ , @ cm@ ) women ( p < @ ) , but dense area did not differ across the three ethnic groups .


Our study shows that higher percent density and lower nondense area reflect the higher incidence of breast cancer in Chinese compared to Malay and Indian women in Malaysia .


Known lifestyle determinants of mammographic density do not fully account for the ethnic variations observed in mammographic density in this Asian cohort .


Many workers suffer from low-back pain .


Type and severity of spinal complaints have relationship with work load .


Lack of adherence to ergonomics recommendations among the important causes of low-back pain .


To assess the effect of @ ergonomics training programs on the prevalence of lowback pain among workers of an Iranian automobile factory .


In a parallel-design @-arm randomized clinical trial , @ active workers of an automobile factory were studied .


@ workers were found eligible and randomized into @ intervention groups ( n = @ ) , and a control group ( n = @ ) .


The intervention groups consisted of @ arms : @ workers were educated by pamphlet , @ by lectures , and @ by workshop .


Nordic questionnaire was used to determine the prevalence of spinal complaint before and @-year after the interventions .


The trial is registered with the Iranian Randomized Clinical Trial Registry , number IRCT@N@ .


Out of @ workers , @ lost to follow-up leaving @ workers for analyses .


The prevalence of low-back pain at the baseline was not significantly different among the studied arms .


@-year after the interventions , the prevalence did not change significantly from the baseline values for the lecture and pamphlet group .


However , the prevalence of LBP experienced during the last year significantly ( p = @ ) decreased from @ % to @ % in participant took part in the workshop .


Training of automobile factory workers in ergonomics is more effective by running workshop than giving lecture or disseminating pamphlet .


The antiepileptic drug lacosamide has a low potential for drug-drug interactions , but is a substrate and moderate inhibitor of the cytochrome P@ ( CYP ) enzyme CYP@C@ .


This phase I , randomized , open-label , two-way crossover trial evaluated the pharmacokinetic effects of lacosamide and omeprazole coadministration .


Healthy , White , male volunteers ( n = @ ) who were not poor metabolizers of CYP@C@ were randomized to treatment A ( single-dose @ mg omeprazole on days @ and @ together with @ days of multiple-dose lacosamide -LSB- @-@ mg/day -RSB- on days @-@ ) and treatment B ( single doses of @ mg lacosamide on days @ and @ with @ days of @ mg/day omeprazole on days @-@ ) in pseudorandom order , separated by a @-day washout period .


Area under the concentration-time curve ( AUC ) and peak concentration ( C ( max ) ) were the primary pharmacokinetic parameters measured for lacosamide or omeprazole administered alone ( reference ) or in combination ( test ) .


Bioequivalence was determined if the @ % confidence interval ( CI ) of the ratio ( test/reference ) fell within the acceptance range of @-@ @ .


The point estimates ( @ % CI ) of the ratio of omeprazole + lacosamide coadministered versus omeprazole alone for AUC ( @ -LSB- @-@ @ -RSB- ) and C ( max ) ( @ -LSB- @-@ @ -RSB- ) fell within the acceptance range for bioequivalence .


The point estimates ( @ % CI ) of the ratio of lacosamide + omeprazole coadministration versus lacosamide alone also fell within the acceptance range for bioequivalence ( AUC @ -LSB- @-@ @ -RSB- ) ; C ( max ) @ ( @-@ @ ) .


Steady-state lacosamide did not influence omeprazole single-dose pharmacokinetics , and multiple-dose omeprazole did not influence lacosamide single-dose pharmacokinetics .


The prevalence of hepatitis-C-virus ( HCV ) infections is high among opioid-dependent individuals .


Prior research on the simultaneous treatment of both conditions has primarily assessed success as it pertains to HCV .


However , it has been noted that favorable substance use therapy outcomes may improve the likelihood of HCV-treatment initiation and success .


Therefore , current guidelines for the treatment of HCV among illicit drug users suggest that treatment for addiction be given the highest priority .


To determine whether opioid-dependent participants in a clinical trial of buprenorphine-treatment tapering regimens , who tested positive for the HCV antibody , experienced significantly different levels of opioid abstinence than those not infected .


Data came from the National Drug Abuse Treatment Clinical Trial Network study @ eligible opioid-dependent participants were randomized to either a @-day or @-day buprenorphine tapering schedule following a @-week buprenorphine stabilization period .


Generalized estimating equations were used to test the research question .


Participants with the HCV antibody were significantly less likely to submit opioid-negative urine analyses during and/or immediately following active treatment -LSB- OR = @ ; CI = @-@ @ -RSB- , indicating a higher rate of opioid use among this group .


Individualized opioid-dependence treatment strategies may be required for opioid-dependent individuals who test positive for the HCV antibody in order to ensure resources for both opioid-dependence and HCV therapies are used efficiently .


Crack-cocaine dependence is a complex disorder with limited treatment options .