This analysis differentially studies the outcomes of patients with simple varicose veins ( C@ : n = @ ) and soft tissue complications ( C@-@ : n = @ ) .


Effectiveness outcomes measured up to @ year included the following : Qol -LSB- short form @ ( SF@ ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire -RSB- , clinical recurrence , and the need for secondary procedures .


Multivariable regression analysis was used to control for potential confounding factors .


Both groups saw significant improvements in QoL .


All improvements were equal between groups apart from the SF@ domain of Bodily Pain , where C@ saw an improvement of @ -LSB- @ % confidence interval ( CI ) : @-@ @ -RSB- points over C@-@ participants ( P = @ ) , who also suffered more recurrence -LSB- odds ratio ( OR ) = @ , @ % CI : @-@ @ , P = @ -RSB- and required more secondary procedures ( OR = @ , @ % CI : @-@ @ , P = @ ) .


This study suggests that rationing by clinical severity contradicts the evidence .


Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence .


To determine whether addition of an electronic sepsis evaluation and management tool to electronic sepsis alerting improves compliance with treatment guidelines and clinical outcomes in septic ICU patients .


A pragmatic randomized trial .


Medical and surgical ICUs of an academic , tertiary care medical center .


Four hundred and seven patients admitted during a @-month period to the medical or surgical ICU with a diagnosis of sepsis established at the time of admission or in response to an electronic sepsis alert .


Patients were randomized to usual care or the availability of an electronic tool capable of importing , synthesizing , and displaying sepsis-related data from the medical record , using logic rules to offer individualized evaluations of sepsis severity and response to therapy , informing users about evidence-based guidelines , and facilitating rapid order entry .


There was no difference between the electronic tool ( @ patients ) and usual care ( @ patients ) with regard to the primary outcome of time to completion of all indicated Surviving Sepsis Campaign @-hour Sepsis Resuscitation Bundle elements ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) or time to completion of each element individually .


ICU mortality , ICU-free days , and ventilator-free days did not differ between intervention and control .


Providers used the tool to enter orders in only @ % of available cases .


A comprehensive electronic sepsis evaluation and management tool is feasible and safe but did not influence guideline compliance or clinical outcomes , perhaps due to low utilization .


Colorectal cancer is a major public health problem .


There is growing support for colorectal cancer survivors who are experiencing problems after cancer treatment to engage in self-management programs to reduce symptom distress .


However , there is inconclusive evidence as to the effectiveness of such program especially in Asian region .


This study tested the effects of a six-month nurse-led self-efficacy-enhancing intervention for patients with colorectal cancer , compared with routine care over a six-month follow up .


A randomized controlled trial with repeated measures , two-group design .


Three teaching hospitals in Guangzhou , China .


One hundred and fifty-two Chinese adult patients with a diagnosis of colorectal cancer were recruited .


The intervention group ( n = @ ) received self-efficacy-enhancing intervention and the control group ( n = @ ) received standard care .


The participants were randomized into either intervention or control group after baseline measures .


The outcomes of the study ( self-efficacy , symptom distress , anxiety , depression and quality of life ) were compared at baseline , three and six months after the intervention .


Sixty-eight participants in the intervention group and @ in the control group completed the study .


Their mean age was @ ( SD = @ ) .


Repeated measure MANOVA found that the patients in the intervention group had significant improvement in their self-efficacy ( F = @ , p = @ ) and a reduction of symptom severity ( F = @ , p = @ ) , symptom interference ( F = @ , p = @ ) , anxiety ( F = @ , p = @ ) and depression ( F = @ , p = @ ) at three and six months , compared with the control group .


However , no statistically significant main effect was observed in quality of life perception between the two groups .


The nurse-led self-efficacy enhancing intervention was effective in promoting self-efficacy and psychological well-being in patients with colorectal cancer , compared with standard care .


The intervention can be incorporated into routine care .


Future empirical work is required to determine the longer term effects of the intervention .


Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results .


The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren .


Cluster randomized trial study of @ schoolchildren , @-@ years , from @ public schools in the Province of Cuenca , Spain .


The intervention ( MOVI-@ ) consisted of play-based and non-competitive activities .


MOVI-@ was conducted during two @-minute sessions on weekdays and one @-minute session on Saturday mornings every week between September @ and May @ .


We measured changes in adiposity ( overweight/obesity prevalence , body mass index -LSB- BMI -RSB- , triceps skinfold thickness -LSB- TST -RSB- , body fat % , fat-free mass , waist circumference ) and other cardiometabolic risk factors ( LDL-cholesterol , triglycerides/HDL-cholesterol ratio , insulin , C-reactive protein and blood pressure ) .


The analyses used mixed regression models to adjust for baseline covariates under cluster randomization .


Among girls , we found a reduction of adiposity in intervention versus control schools , with a decrease in TST ( -@ mm ; @ % confidence interval -LSB- CI -RSB- -@ to -@ ) , body fat % ( -@ % ; @ % CI -@ to -@ ) , waist circumference ( -@ cm ; @ % CI -@ to -@ ) , and an increase in fat-free mass ( @ kg ; @ % CI @ to @ ) .


The intervention also led to lower serum LDL-cholesterol and insulin levels .


Among boys , a reduction in waist circumference ( -@ cm ; @ % CI -@ to -@ ; P = @ ) , and an increase in fat-free mass ( @ kg ; @ % CI @ to @ ; P = @ ) was associated with the intervention versus control schools .


The prevalence of overweight/obesity or underweight , BMI , and other cardiometabolic risk factors was not modified by the intervention .


No important adverse events were registered .


An extracurricular intervention of non-competitive physical activity during an academic year , targeting all schoolchildren regardless of body weight , is a safe and effective measure to reduce adiposity in both genders and to improve cardiometabolic risk profile in girls .


We investigated potential biomarkers of efficacy in a phase III trial of sunitinib versus interferon-alpha ( IFN - ) , first-line in metastatic renal cell carcinoma ( mRCC ) , by analyzing plasma levels of vascular endothelial growth factor ( VEGF ) - A , VEGF-C , soluble VEGF receptor-@ ( sVEGFR-@ ) and interleukin ( IL ) -@ .


Seven hundred and fifty mRCC patients were randomized to oral sunitinib @ mg/day in repeated cycles of a @-week on/@-week off schedule or IFN - @ million units subcutaneously thrice weekly .


Plasma samples collected from a subset of @ patients on days @ and @ of cycles @-@ and at end of treatment were analyzed by ELISA .


Baseline characteristics of biomarker-evaluated patients in sunitinib ( N = @ ) and IFN - ( N = @ ) arms were comparable to their respective intent-to-treat populations .


By univariate Cox regression analysis , low baseline soluble protein levels were associated with lower risk of progression/death ( all P < @ ) : in both treatment arms , baseline VEGF-A and IL-@ were associated with overall survival ( OS ) and baseline VEGF-C with progression-free survival ( PFS ) ; in the sunitinib arm , baseline VEGF-A was associated with PFS and baseline sVEGFR-@ with PFS and OS ; in the IFN - arm , baseline IL-@ was associated with PFS .


In multivariate analysis , baseline sVEGFR-@ and IL-@ remained independent predictors of OS in the sunitinib arm , while no independent predictors of outcome remained in the IFN - arm .


Pharmacodynamic changes were not associated with PFS or OS for any plasma protein investigated .


Our findings suggest that , in mRCC , baseline VEGF-A and IL-@ may have prognostic value , while baseline sVEGFR-@ may predict sunitinib efficacy .


The aim of the study was to evaluate the relation between nutritional intake ( kilocalories , protein ) and weight and length growth in preterm infants , and to describe their metabolic tolerance with a focus on those with high protein intake ( @ g kg ( -@ ) day ( -@ ) ) .


Secondary analysis of data from appropriate-for-gestational age preterm infants in a @-day randomized clinical trial that evaluated growth , tolerance , and safety of a new ultraconcentrated liquid human milk fortifier ( original study n = @ ) .


This subset of @ infants had complete growth and nutrition data and met criteria for the original study 's `` efficacy analysis '' ( eg , > @ % of kilocalorie intake from study diet ) .


Nutritional intake was estimated , not actual .


Regressions were used to test cumulative kilocalories and protein as the predictors of @-day change in weight and length z scores ( growth status ) , and to evaluate protein tolerance .


Average intake was @ @ kcal kg ( -@ ) day ( -@ ) and @ @ g protein kg ( -@ ) day ( -@ ) , with @ @ g kg ( -@ ) day ( -@ ) and @ @ cm/week growth for @ days .


Cumulative total kilocalories and protein were significant predictors of improved length z score ( P = @ , @ ) but not weight z score change .


Regression models indicated that protein not kilocalories explained the improvement in length z score , with protein explaining @ % of the variability .


The high protein group averaged @ to @ g kg ( -@ ) day ( -@ ) ( n = @ ) .


Protein tolerance was adequate for all of the study infants based on metabolic measures ( blood urea nitrogen , serum carbon dioxide , pH ) .


Higher cumulative protein intake was tolerated and overall lessened the commonly occurring decline in the length but not weight growth status in a @-day study of preterm infants .


The objective of this study was to investigate whether ingestion of fructose and fructans ( such as inulin ) can exacerbate irritable bowel syndrome ( IBS ) symptoms .


The aim was to better understand the origin of these symptoms by magnetic resonance imaging ( MRI ) of the gut .


A total of @ healthy volunteers participated in a four-way , randomized , single-blind , crossover study in which they consumed @ml of water containing @g of either glucose , fructose , inulin , or a @:@ mixture of @g glucose and @g fructose .


MRI scans were performed hourly for @h , assessing the volume of gastric contents , small bowel water content ( SBWC ) , and colonic gas .


Breath hydrogen ( H@ ) was measured and symptoms recorded after each scan .


Data are reported as mean ( s.d. ) ( @ % CI ) when normally distributed and median ( range ) when not .


Fructose increased area under the curve ( AUC ) from @-@h of SBWC to @ ( @ ) l/min , significantly greater than for glucose at @ ( @-@ ) l/min ( P < @ ) , whereas AUC SBWC after inulin , @ ( @-@ ) l/min , was no different from that after glucose .


Adding glucose to fructose decreased AUC SBWC to @ ( @ ) l/min ( P = @ ) vs. fructose .


Inulin substantially increased AUC colonic gas to @ ( @ ) l/min , significantly greater than glucose and glucose + fructose ( both P < @ ) .


Breath H@ rose more with inulin than with fructose .


Glucose when combined with fructose significantly reduced breath H@ by @,@ ( @,@-@ ,@ ) p.p.m. / min relative to fructose alone ( P < @ , n = @ ) .


Fructose but not inulin distends the small bowel with water .


Adding glucose to fructose reduces the effect of fructose on SBWC and breath hydrogen .


Inulin distends the colon with gas more than fructose , but causes few symptoms in healthy volunteers .


This open-label phase III trial evaluated efficacy and tolerability of linifanib versus sorafenib in patients with advanced hepatocellular carcinoma ( HCC ) without prior systemic therapy .


Patients were randomly assigned in a @:@ ratio to linifanib @ mg once daily or sorafenib @ mg twice daily .


Patients were stratified by region ( Outside Asia , Japan , and rest of Asia ) , Eastern Cooperative Oncology Group performance score ( ECOG PS ; @ or @ ) , vascular invasion or extrahepatic spread ( yes or no ) , and hepatitis B virus ( HBV ) infection ( yes or no ) .


The primary end point of the study was overall survival ( OS ) .


Secondary end points were time to progression ( TTP ) and objective response rate ( ORR ) per RECIST v@ @ .


We randomly assigned @,@ patients ( median age , @ years ; Asian , @ % ; ECOG PS @ , @ % ; HBV , @ % ; vascular invasion or extrahepatic spread , @ % ) .


Median OS was @ months on the linifanib arm ( @ % CI , @ to @ ) and @ months on the sorafenib arm ( @ % CI , @ to @ ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) .


For prespecified stratification subgroups , OS HRs ranged from @ to @ and the @ % CI contained @ .


Median TTP was @ months on the linifanib arm ( @ % CI , @ to @ ) and @ months on the sorafenib arm ( @ % CI , @ to @ ; HR , @ ; @ % CI , @ to @ ; P = @ ) .


Best response rate was @ % on the linifanib arm versus @ % on the sorafenib arm .


Grade @/@ adverse events ( AEs ) ; serious AEs ; and AEs leading to discontinuation , dose interruption , and reduction were more frequent with linifanib ( all P < @ ) .


Linifanib and sorafenib had similar OS in advanced HCC .


Predefined superiority and noninferiority OS boundaries were not met for linifanib and the study failed to meet the primary end point .


TTP and ORR favored linifanib ; safety results favored sorafenib .


While many of the commonly used conservative treatments for knee osteoarthritis ( OA ) have been recognized to be effective , there is still insufficient evidence available .


Among the pharmacological treatments for knee OA , oral non-steroidal anti-inflammatory drugs ( NSAIDs ) act rapidly and are recommended for the management of OA .


However , frequent and serious adverse effects of NSAIDs have been recognized .


Intra-articular injections of hyaluronic acid ( IA-HA ) for the treatment of knee OA have been shown to reduce pain and improve joint function .


However , there has been no qualified direct comparison study of the efficacy and safety between IA-HA and NSAIDs for patients with knee OA .


The aim of this study was to clarify the efficacy and safety of early-phase IA-HA in comparison to those of NSAIDs for patients with knee OA .


This multicenter , randomized , open-label , parallel-group , non-inferiority comparison study with an oral NSAID involved a total of @ patients with knee OA .


An independent , computer-generated randomization sequence was used to randomly assign patients in a @:@ ratio to NSAIDs three times per day for five weeks ( n = @ ) or IA-HA once a week for five weeks ( n = @ ) .


The primary endpoint was the percentage change in the patient-oriented outcome measure for knee OA , the Japanese Knee Osteoarthritis Measure ( JKOM ) score .


All patients were questioned regarding any adverse events during treatment .


The full analysis set ( FAS ) was used for analysis .


The margin of non-inferiority was @ % .


The analyses of primary endpoint included @ patients in the IA-HA group and @ patients in the NSAID group .


The difference in the percentage changes of the JKOM score between the two intervention arms ( IA-HA ; -@ % ( P < @ ) , NSAID ; -@ % ( P < @ ) ) was -@ % ( @ % confidence interval ( CI ) : -@ to @ ) , indicating IA-HA was not inferior to NSAID .


The frequency of both withdrawal and adverse events in the IA-HA group were significantly lower than those in the NSAID group ( P = @ and @ , respectively ) .


The early efficacy of IA-HA is suggested to be not inferior to that of NSAIDs , and that the safety of the early phase of IA-HA is superior to that of NSAIDs for patients with knee OA .


Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published .


The ELIOT Trial used electrons ( IOERT ) , and the TARGIT-A Trial Update used @-kV X-rays ( IORT ) .


These studies were compared for similarities and differences .


The results were analyzed and used to determine which patients might be suitable for single-dose treatment .


The primary sources of data were the ELIOT Trial and TARGIT-A Trial , as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation ( APBI ) using @-kV X-rays or electrons .


Studies published or presented prior to March @ were analyzed for efficacy , patient restrictions , complications , and outcome .


With a median follow-up of @ years , the @-year recurrence rates for ELIOT versus external beam radiation therapy ( EBRT ) patients were @ % and @ % , respectively , p = @ .


A low-risk ELIOT group was identified with a @-year recurrence rate of @ % .


With a median follow-up of @months , the @-year recurrence rates for the TARGIT-A versus EBRT patients were @ % and @ % , respectively , p = @ .


With @ years of median follow-up , IOERT appears to have a subset of low-risk women for whom IOERT is acceptable .


With @months of median follow-up the results of IORT with @-kV devices are promising , but longer follow-up data are required .


At the current time , single-fraction IOERT or IORT patients should be treated under strict institutional protocols .


To examine whether baseline obesity severity modifies the effects of two different , primary care-based , technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome .


We compared mean differences in changes from baseline to @ months in clinical measures of general and central obesity among participants randomized to usual care alone ( n = @ ) or usual care plus a coach-led group ( n = @ ) or self-directed individual ( n = @ ) intervention , stratified by baseline body mass index ( BMI ) category .


Participants with baseline BMI @ + had greater reductions in mean BMI , body weight ( as percentage change ) , and waist circumference in the coach-led group intervention , compared to usual care and the self-directed individual intervention ( P < @ for all ) .


In contrast , the self-directed intervention was more effective than usual care only among participants with baseline BMIs between @ @ .


Mean weight loss exceeded @ % in the coach-led intervention regardless of baseline BMI category , but this was achieved only among self-directed intervention participants with baseline BMIs < @ .


Baseline BMI may influence behavioral weight-loss treatment effectiveness .


Researchers and clinicians should take an individual 's baseline BMI into account when developing or recommending lifestyle focused treatment strategy .


This trial is registered with ClinicalTrials.gov NCT@ .


Patients ' reported opinions of the health system need to be understood in order to provide patient-centered care .


We investigated determinants of women 's ratings of the quality of care during their most recent facility delivery .


We conducted a census of all deliveries in the @ weeks to @ months preceding the survey , in villages served by @ primary care clinics in rural Pwani Region , Tanzania .


Women who had delivered children in a study facility were included in this analysis ( n = @ ) .


We interviewed women about demographic and obstetric factors and the quality of their obstetric care using a structured questionnaire .


We created a composite index of perceived quality from six quality questions .


We also assessed the functioning of the local health clinic using structured surveys .


We used a multi-level model to analyze factors associated with women 's rating of the quality of care during delivery .


@ % of respondents rated the overall quality of care received during delivery as excellent .


Women who listened to the radio daily reported lower quality composite scores ( : -@ , p < @ ) .


Women who reported receiving more services in ANC had higher quality scores ( : @ , p = @ ) , as did women receiving more delivery services ( : @ , p < @ ) .


Women who reported disrespect and abuse during delivery had significantly lower quality scores ( : -@ , p < @ ) .


A woman 's expectations and prior and current experiences influence her perception of the quality of care she received .


Health facility characteristics did not influence ratings of overall quality .


Focusing on improving the process rather than inputs of service delivery during ANC visits and delivery may increase perceived quality of delivery care in low-resource settings .


There is a lack of knowledge about antidementia drug treatment in community dwelling people with dementia in Germany .


To determine the frequency of treatment with antidementia drugs in patients in primary care , and the socio-demographic and clinical variables associated with antidementia drug treatment .


Present analyses are based on preliminary data from the DelpHi-trial , an ongoing GP-based , cluster-randomized , controlled intervention trial to implement and evaluate an innovative concept of collaborative dementia care management in Germany .


Our sample consists of n = @ subjects who screened positive for dementia .


@ % ( n = @ ) of participants received antidementia drugs : memantine @ % ( n = @ ) ; donepezil @ % ( n = @ ) ; rivastigmine @ % ( n = @ ) ; galantamine @ % ( n = @ ) .


A total of @ % ( n = @ ) of the subgroup of participants with a formal dementia diagnosis received antidementia drug treatment .


Approximately @ % ( n = @ ) of our sample received treatment with antidementia drugs without having a formal diagnosis .


Treatment with antidementia drugs was significantly associated with more severe cognitive impairment and having a formal dementia diagnosis .


One in three people who screened positive for dementia in primary care received antidementia drug treatment , indicating the frequent use of this class of drugs .


For those with a formal dementia diagnosis , these drug treatment rates are more than triple , compared to those in nursing homes .


Internet-delivered trauma-focused cognitive behavioural therapy is efficacious for PTSD ; however , no studies have investigated the roles of individual treatment components or the safety of online treatments .


To compare the efficacy and safety of an online treatment for PTSD comprised of psychoeducation , stress management , cognitive restructuring and exposure components with the equivalent protocol without the exposure components , using a randomised controlled trial design .


Sixty-six individuals were randomised to a non-exposure condition and @ to the full protocol with exposure components .


Treatment duration was @ weeks and pre - , post-treatment and three-month follow-up outcomes were analysed using a mixed linear modelling approach .


Both groups achieved improvements in symptoms with no differences between groups on any primary or secondary outcome measures , diagnostic remission rates or adverse events .


The study included several secondary measures that have not been previously validated and treatments were not time matched in terms of number of lessons .


These findings indicate that trauma-focused cognitive behavioural therapy for PTSD with or without exposure components can be safe and efficacious .


Patients with genotype @ hepatitis C virus ( HCV ) infection and cirrhosis have poor response rates after @ weeks treatment with pegylated interferon and ribavirin .


Treatment for @ weeks is therefore recommended , although the benefits of this are untested .


We examined extended therapy in patients with genotype @ HCV and advanced fibrosis .


Multicentre , open labelled randomized trial comparing therapy with @ weeks pegylated interferon and ribavirin to @ weeks of the same therapy .


@ patients completed the study .


@ received @ weeks therapy and the SVR rate ( @ % ) did not differ from that seen in the @ patients who received @ weeks therapy ( @ % ) .


The response rates in patients with biopsy proven cirrhosis ( @ patients treated for @ weeks , @ patients treated for @ weeks ) or cirrhosis proven on imaging ( @ patients treated for @ weeks and @ patients treated for @ weeks ) were @ % in those treated for @ weeks and @ % in those treated for @ weeks .


The differences were not significantly different .


Treatment failure was due to relapse in the majority of patients .


Patients with genotype @ HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin .


Epidemiological research links aggression to low serum concentrations of omega-@ fatty acids , such as those found in fish oil .


However , no studies have specifically examined whether fish oil supplementation can reduce the frequency and severity of impulsive aggression in children with disruptive behavior disorders .


Children presenting with impulsive aggression and meeting research criteria for diagnosis of disruptive behavior disorders were randomized to receive either : @ ) Fish oil capsules ( @g daily ) for @ weeks followed by placebo ( identical-looking capsules ) for @ weeks ; or @ ) placebo for @ weeks , followed by fish oil for @ weeks , in a double-blind , crossover design .


Primary outcomes were the Children 's Aggression Scale and the Modified Overt Aggression Scale .


Secondary outcomes included emotional and behavioral functioning ( Strengths and Difficulties Questionnaire -LSB- SDQ -RSB- ) , hyperactivity symptoms ( Attention-Deficit/Hyperactivity Disorder -LSB- ADHD -RSB- Rating Scale ) , family functioning ( Family Assessment Device ) , and cognitive functioning ( Stop Signal Task , Trail-Making Task , and Eriksen Flanker Task ) .


Serum concentrations of omega-@ and omega-@ fatty acids were measured at baseline , and at @ and @ weeks .


Twenty-one children participated ( @ % male ; mean age @ years ; range @-@ ) .


Fish oil treatment increased serum concentrations of eicosapentanoic acid ( F = @ , p < @ ) and total omega-@s ( F = @ , p < @ ) , but did not influence primary ratings of aggression .


In fact , a trend suggested that fish oil worsened a secondary measure of aggression ( SDQ Conduct Subscale , F = @ , p = @ ) .


Fish oil treatment was associated with an improvement in one rating of hyperactivity ( SDQ Hyperactivity Subscale , F = @ , p < @ ) , but did not influence any other outcome measures .


These findings suggest that fish oil treatment does not improve aggression in children with disruptive behavior disorders .


To compare outcomes of illuminated microcatheter-assisted circumferential trabeculotomy vs combined mitomycin C-augmented trabeculotomy-trabeculectomy for primary congenital glaucoma .


Prospective , randomized trial .


Of the @ patients ( @ eyes ) analyzed with bilateral primary congenital glaucoma aged @ years , @ eye of each patient was randomized to : illuminated microcatheter-assisted trabeculotomy ( Group I ) or combined trabeculotomy with trabeculectomy augmented with mitomycin C ( Group II ) .


Primary outcome measure was intraocular pressure ( IOP ) reduction .


Categorization into absolute success ( IOP @mm Hg without medication ) and qualified success ( IOP @mm Hg with medication ) was done .


Secondary outcomes included change in corneal diameter and clarity , optic disc status , refraction , need for anti-glaucoma therapy , and occurrence of complications .


Mean age of patients was @ @ months .


IOP fell by @ % ( @ @ to @ @ mm Hg ) in Group I and @ % in Group II ( @ @ to @ @ mm Hg ) ( P < @ in both ) .


At @ year , absolute success was achieved in @ % ( @/@ ) and @ % ( @/@ ) in Groups I and II , respectively ( P > @ ) and qualified success in @ % ( @/@ ) in both groups ( P = @ ) .


There was significant improvement in corneal clarity ( P < @ ) and cup-to-disc ratio ( P @ ) in both groups at @ year .


Though incidence of hyphema was significantly more in Group I ( P = @ ) , no vision-threatening complications occurred in either group .


Illuminated microcatheter-assisted circumferential trabeculotomy achieved comparable surgical outcomes to mitomycin C-augmented combined trabeculotomy-trabeculectomy and may be recommended as the initial surgical procedure for primary congenital glaucoma .


Non-attenders for cervical screening are at increased risk of cervical cancer .


Studies offering self-sampling for high-risk Human Papillomavirus ( HrHPV ) testing have shown greater uptake than sending another invitation for cytology .


To explore whether uptake would increase in a less diverse , more stable population than the previous English study , which demonstrated a lower response rate than other studies .


The primary objective was whether non-attenders were more likely to respond to a postal invitation , including kit , to collect a self-sample compared with a further invitation for cytology screening .


The secondary objective was whether women with an abnormal result would attend for follow-up .


@ non-attenders for screening in this pragmatic , randomized ( @:@ ) controlled trial in Newcastle-upon-Tyne were sent an HPV self-sample kit ( intervention ) or a further invitation for cytology screening ( comparator ) .


@ ( @ % ) responded to the intervention , returning a self-sample ( @ ( @ % ) ) or attending for cytology ( @ ( @ % ) ) , compared with @ ( @ % ) attending for cytology , relative risk @ ( @ % CI @-@ @ ) ( comparator arm ) .


Of those testing hrHPV positive ( @ ( @ % ) ) , @ ( @ % ) subsequently attended cytology screening .


Of those in the intervention group who attended for cytology screening without returning an hrHPV self-sample ( n = @ ) , @ % ( n = @ ) were referred for colposcopy-all attended .


In the comparator group eight of the nine referred for colposcopy attended .


Persistent non-responders to invitations for cervical screening are significantly more likely to respond to a postal invitation to return a self-collected sample for HPV testing than a further invitation for cytology screening .


However , just over half followed up on this positive HPV result .


To examine how the location where reading takes place and the availability of prior images can affect performance in breast test-set reading .


Under optimized viewing conditions , @ expert screen readers each interpreted a reader-specific set of images containing @ mammographic cases .


Readers , randomly divided into two groups read images under one of two pairs of conditions : clinical read with prior images and laboratory read with prior images ; laboratory read with prior images and laboratory read without prior images .


Region-of-interest ( ROI ) figure-of-merit ( FOM ) was analysed using JAFROC software .


Breast side-specific sensitivity and specificity were tested using Wilcoxon matched-pairs signed rank tests .


Agreement between pairs of readings was measured using Kendall 's coefficient of concordance .


Group performances between test-set readings demonstrated similar ROI FOMs , sensitivity and specificity median values , and acceptable levels of agreement between pairs of readings were shown ( W = @-@ @ , p < @ ) for both pairs of reading conditions .


On an individual reader level , two readers demonstrated significant decreases ( p < @ ) in ROI FOMs when prior images were unavailable .


Reading location had an inconsistent impact on individual performance .


Reading location and availability of prior images did not significantly alter group performance .


Effective strategies for contacting and recruiting study participants are critical in conducting clinical research .


In this study , we conducted two sequential randomized controlled trials of mail - and telephone-based strategies for contacting and recruiting participants , and evaluated participant-related variables ' association with time to survey completion and survey completion rates .


Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a @-month observational follow-up study evaluating their physical , cognitive and mental health outcomes , with their last study visit completed at a median of @ months previously .


Eligible subjects were contacted to complete a new research survey as part of two randomized trials , initially using a randomized mail-based contact strategy , followed by a randomized telephone-based contact strategy for non-responders to the mail strategy .


Both strategies focused on using either a personalized versus a generic approach .


In addition , @ potentially relevant subject-related variables ( e.g. , demographics , last known physical and mental health status ) were evaluated for association with time to survey completion .


Of @ eligible subjects , @ % completed the survey with a median ( IQR ) of @ ( @ , @ ) contact attempts required .


There was no significant difference in the time to survey completion for either randomized trial of mail - or phone-based contact strategy .


Among all subject-related variables , age @ years and minority race were independently associated with a longer time to survey completion .


We found that age @ years and minority race were associated with a longer time to survey completion , but personalized versus generic approaches to mail - and telephone-based contact strategies had no significant effect .


Repeating both mail and telephone contact attempts was important for increasing survey completion rate .


The purpose of this study was to compare the pain rating scale measurements from an exposure group ( injections with the aid of DentalVibe Injection Comfort System ) and control group ( traditional injection without the aid of the DentalVibe ) in adolescent patients using self-reported pain during administration of local anesthetic injections .


This was a randomized , controlled study .


Subjects consisted of @ @ - to @-year-old patients who required local anesthesia for dental treatment on both sides of the maxilla or mandible .


All subjects received a conventional injection ( control ) and an injection using DentalVibe ( experimental ) .


A pain rating for each injection was obtained from subjects using the Wong-Baker FACES Pain Rating Scale .


Statistical analysis using a Wilcoxon signed rank test found a significant reduction in pain ratings for injections with the DentalVibe when compared to control injections .


There was a positive correlation between the pain rating for control injection and the difference between the two types of injection , indicating that subjects who reported a higher pain score with the control injection had a greater reduction when DentalVibe was used .


When compared to a conventional approach , DentalVibe significantly lowered self-reported pain during local anesthesia injection for adolescent subjects in this study .


Recent recommendations for lung protective mechanical ventilation include a tidal volume target of @ mL/kg predicted body weight ( PBW ) .


Different PBW equations might introduce important differences in tidal volumes delivered to research subjects and patients .


PBW equations use height , age , and sex as input variables .


We compared National Institutes of Health ( NIH ) ARDS Network ( ARDSNet ) , actuarial table ( ACTUARIAL ) , and Stewart ( STEWART ) PBW equations used in clinical trials , across physiologic ranges for age and height .


We used three-dimensional and two-dimensional surface analysis to compare these PBW equations .


We then used age and height from actual clinical trial subjects to quantify PBW equation differences .


Significant potential differences existed between these PBW predictions .


The ACTUARIAL and ARDSNet surfaces for women were the only surfaces that intersected and produced both positive and negative differences .


Mathematical differences between PBW equations at limits of height and age exceeded @ % in women and @ % in men for ACTUARIAL vs ARDSNet and about @ % for women and @ % for men for STEWART vs ARDSNet .


The largest mathematical differences were present in older , shorter subjects , especially women .


Actual differences for clinical trial subjects were as high as @ % for men and @ % for women .


Significant differences between PBW equations for both men and women could be important sources of interstudy variation .


Studies should adopt a standard PBW equation .


We recommend using the NIH National Heart , Lung , and Blood Institute ARDS Network PBW equation because it is associated with the clinical trial that identified @ mL/kg PBW as an appropriate target .


The authors examined the impacts of whole-body vibration ( WBV ) applications on balance control in postmenopausal women using clinical balance tests and computerized static posturography .


Patients were randomly divided into two groups and treated with WBV and/or home-based balance coordination exercises ( BCEs ) .


Patients in the WBV-BCE group were asked to stand on the platform in standing , squat , and deep squat positions .


During each position , @-sec vibration ( @-@ Hz ) and @-sec rest periods were applied twice ( @ sessions in total ) .


The BCE program was performed by subjects twice per day .


All subjects were evaluated before and after treatment using the Timed Up and Go test and the Berg Balance Scale ( BBS ) .


The fall index and the Fourier index were assessed via computerized static posturography .


Sixty patients were recruited for the study , but only @ patients ( @ in each group ) completed it .


Fall index and the total values of the Fourier index @-@ and Fourier index @-@ frequencies indicated a significant improvement in the WBV-BCE group ( P < @ ) .


Both groups showed significant improvements in the Berg Balance Scale and Timed Up and Go test ( P < @ ) .


The ease of applying WBV furthermore supports its inclusion in daily treatment protocols for age-related decline in balance performance in women and improved balance and mobility measures associated with increased fall risk .


There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing .


After designing and building devices capable of generating an electromagnetic field for this study , their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis .


Treatment began six weeks after the fracture and it was administered once a day , during @ h , for eight consecutive weeks .


Twenty device were built , @ of which were placebo-devices .


Between June @ and October @ , @ patients were randomized in two different hospitals and were followed for @ weeks .


The mean age was @ years ( @-@ ) and @ % were males .


Healing observed at week @ was @ % vs. @ % ( p = @ ) ; at week @ it was @ % vs. @ % ( p = @ ) ; and at week @ it was @ % vs. @ % ( p = @ ) for the device group and the placebo group , respectively .


This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures .


Faster bone healing translates into sooner weight bearing , which -- in turn -- permits quicker return to normal daily activities .


The aim of this study was to assess in healthy subjects the safety , tolerability , pharmacokinetics , and pharmacodynamics of ponesimod , an oral selective sphingosine-@-phosphate receptor @ ( S@P@ ) modulator in development for multiple sclerosis , by using an uptitration scheme up to supratherapeutic doses .


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


Male and female subjects received ascending oral doses of ponesimod ( n = @ ) or placebo ( n = @ ) once daily for @ days at each dose level ( @-@-@-@-@-@mg ) .


The most frequent adverse events were chest discomfort , headache , dizziness , dyspnoea , abdominal pain , and night sweats .


Chest discomfort and dyspnoea were considered dose-limiting .


A transient decrease in heart rate was observed following the first @-mg ponesimod dose ( maximum mean decrease of @ beats per minute ( bpm ) ( placebo : @ bpm ) ) .


After uptitration , effects on heart rate were indistinguishable from placebo .


A dose-dependent effect on pulmonary function tests was observed and reached a plateau with @-@ mg ponesimod ( maximum mean decrease from baseline of @ l ( -@ % ) in forced expiratory volume in @s ) .


A plateau in mean lymphocyte count reduction of approximately @ % from baseline was reached at the @ mg dose level .


Observed effects were fully reversible within @days after treatment discontinuation .


No relevant sex differences were observed .


At supratherapeutic doses , symptoms of chest discomfort and dyspnoea were dose-limiting .


An uptitration dosing scheme is to be preferred in clinical studies in patients in order to limit effects of ponesimod on heart rate and atrioventricular ( AV ) conduction .


A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness .


One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects .


We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study , a randomized trial of Internet and telephone treatment for smoking cessation .


Participants were randomized to a basic Internet ( BI ) comparison condition ( N = @ ) , enhanced Internet ( EI : N = @ ) , or EI plus telephone counseling ( EI+P : N = @ ) .


The primary outcome was @-day point prevalence abstinence ( ppa ) at @ and @ months .


Assigned intervention use was assessed with automated tracking data .


Assessment of non-assigned treatments included pharmacotherapy , behavioral , alternative , and non-study Internet treatments .


Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with @-day ppa .


About @ % of participants used at least one non-assigned treatment .


A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both @ and @ months .


Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with @-day ppa at @ and @ months , and pharmacotherapy and behavioral treatment use was negatively associated with @-day ppa at @ months .


Non-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions .


Results highlight methodological issues in selecting a comparison condition .


Researchers should report non-assigned treatment use alongside main trial outcomes .


To explore the effects of nutritional liquid supplement designed for diabetes mellitus on postprandial glucose state and pregnancy outcomes in patients with gestational diabetes mellitus ( GDM ) .


A total of @ cases of pregnant GDM women at Department of Obstetrics & Gynecology , First Affiliated Hospital , Chongqing Medical University from October @ to January @ were randomized into the intervention and control groups .


But only @ cases in intervention group finished the study versus @ cases in control group .


The inter-group differences were analyzed for general clinical profiles before intervention , @-hour postprandial blood glucose levels and pregnancy outcomes , etc. .


The General Linear Model Repeated Measures process was used to analyze the variance of @-hour postprandial blood glucose data .


And the Mauchy 's test of sphericity was employed to determine the correlation .


( @ ) No significant difference in general clinical profiles before intervention between intervention and control groups ( P > @ ) .


( @ ) The mean values of @-hour postprandial blood glucose were as follows : intervention group ( mmol/L ) : @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) ; control group : @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) , @ @ ( @w ) .


The results of Mauchy 's test of sphericity indicated that the blood glucose level of the intervention group was significantly lower than that of the control group ( P < @ ) .


( @ ) The incidence of premature rupture of membranes and polyhydramnios , rate of neonatal pneumonia , weight of newborn and pregnancy women and level of glycosylated hemoglobin in intervention group were significantly lower than those in control group ( P < @ ) .


Compared with common diet , after using nutritional supplement , the postprandial blood glucose level is significantly reduced and the pregnancy outcomes also improved in GDM patients .


This prospective randomized study evaluated the efficacy of a @ mm locking plate/screw system compared with a @-mm nonlocking plate/screw system in fixation of @ isolated non-comminuted mandibular angle fractures .


Sixty patients were randomly assigned to receive a @ mm locking plate ( group A , n = @ ) or @ mm non-locking plate ( group B , n = @ ) .


All patients were followed up to @ months postoperatively and evaluated for complications , occlusal stability and overall results of fixation .


Five complications occurred in the locking group and fourteen in the non-locking group with complication rates equalling @ % and @ % respectively .


When comparing the overall results according to plates used , the test showed a statistically significant difference between the locking and non-locking plates ( p < @ ) .


Fewer patients required IMF in group A.


Mandibular angle fractures treated with @ mm locking plates show greater stability and were associated with fewer complications than with @ mm non-locking plates .


To conduct a follow-up association mapping to independent genome-wide linkage and admixture mapping studies of uterine leiomyoma .


Case-control , cross-sectional study .


Not applicable .


A total of @,@ premenopausal North American participants in the National Institute of Environmental Health Sciences Uterine Fibroid Study .


None .


We genotyped @,@ single-nucleotide polymorphisms from candidate genes located in peaks of linkage ( @q@ , @p@ , @p@ , @p@ , @p@ , @q@ , and @q@ ) or admixture linkage disequilibrium ( @q@ , @p@ @ , and @q@ ) mapping and reported to have regulated expression in uterine fibroids .


We report significant associations of variant members of the collagen gene family with risk and tumor size , including missense variants in COL@A@ and COL@A , with replications in African American and European American study groups .


Furthermore , the cell-matrix Rho GTPase-encoding ARHGAP@ gene , and MAN@C@ , a gene encoding a Golgi mannosidase involved in the maturation of procollagens , emerged as new candidate uterine leiomyoma genes affecting both risk and tumor size .


Our data converge onto a possible model of uterine leiomyoma pathogenesis resulting from altered regulation , maintenance , and/or renewal of the extracellular matrix .


Ureaplasma urealyticum biovar @ ( UU-@ ) , but not Ureaplasma parvum ( UP ) , has been associated with non-gonococcal urethritis ( NGU ) , but little is known about species-specific responses to standard therapies .


We examined species-specific treatment outcomes and followed men with treatment failure for @weeks .


From May @ to July @ , men aged @ attending a sexually transmitted disease ( STD ) clinic in Seattle , Washington , with NGU ( urethral discharge or urethral symptoms plus @ polymorphonuclear leucocytes / high-powered field ) enrolled in a double-blind , randomised trial .


Participants received active azithromycin ( @g ) + placebo doxycycline or active doxycycline ( @mg twice a day @days ) + placebo azithromycin .


Ureaplasma were detected in culture followed by species-specific PCR .


Outcomes were assessed at @ , @ and @weeks .


At @weeks , men with persistent Ureaplasma detection received ` reverse therapy ' ( e.g. , active doxycycline if they first received active azithromycin ) .


At @weeks , persistently positive men received moxifloxacin ( @mg@days ) .


Of @ men , @ ( @ % ) and @ ( @ % ) were infected with UU-@ and UP , respectively , and returned at @weeks .


Persistent detection was similar for UU-@-infected men initially treated with azithromycin or doxycycline ( @ % vs. @ % ; p = @ ) , but differed somewhat for men with UP ( @ % vs. @ % ; p = @ ) .


At @weeks , @ % of UU-@-infected and @ % of UP-infected men who received both drugs had persistent detection .


Failure after moxifloxacin occurred in @ % and @ % , respectively .


Persistent detection of UU-@ or UP was not associated with signs/symptoms of NGU .


Persistent detection after treatment with doxycycline , azithromycin and moxifloxacin was common for UU and UP , but not associated with persistent urethritis .


To explore effects of whole-head/body tilt in the roll plane on ocular-vestibular evoked myogenic potentials ( oVEMP ) .


Twenty healthy subjects were randomly tilted in an Eply Omniax rotator across a series of eight angles from @ to @ ( at @ separations ) in the roll plane .


At each position , oVEMPs to air-conducted ( AC ) and bone-conducted ( BC ) stimulation were recorded from unrectified infra-orbital surface electromyography during upward gaze .


oVEMP amplitudes , latencies and amplitude asymmetry were compared across each angle of orientation .


Head orientation had a significant effect on oVEMP reflex amplitudes for both AC and BC stimulation ( p < @ ) .


For both stimuli there was a trend for lower amplitudes with increasing angular departure from the upright position .


Mean amplitudes decreased by @-@ @ % ( AC ) and @-@ @ % ( BC ) when tilted @ .


Roll-plane tilt had a significant effect on amplitude asymmetry ratios recorded in response to AC stimuli ( p < @ ) , indicating a trend for lower amplitudes from the dependent ( down ) ear .


Amplitude asymmetry ratios for BC stimuli were unaffected by head and body orientation .


The results confirm an effect of head and body orientation on oVEMP reflexes recorded in response to air - and bone-conducted stimuli .


The upright position yields an optimal oVEMP response .


To evaluate the efficacy and safety of nebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates at high risk of bronchopulmonary dysplasia ( BPD ) .


Single-center , randomized , double-blind , placebo-controlled trial was conducted .


Infants of @ ( @ ) to @ ( @ ) weeks ' gestational age requiring mechanical ventilation or @ % supplemental oxygen on continuous positive airway pressure at @-@ hours were randomized to receive @ mg/kg ( @ mL/kg ) nebulized pentoxifylline or an equal volume of normal saline placebo every @ hours for @ consecutive days via a vibrating mesh nebulizer .


The primary outcome was the duration of oxygen supplementation at @ weeks ' postmenstrual age .


We used Cox proportional hazards regression modeling to analyze outcomes .


All infants had adequate data for analysis of the primary outcome .


Intention-to-treat analysis revealed no differences in duration of oxygen supplementation at @ weeks ' postmenstrual age between pentoxifylline ( n = @ ) and placebo ( n = @ ) groups ( median @ vs @ hours , adjusted hazard ratio : @ , @ % CI @-@ @ , P = @ ) .


There was no difference in mortality and further secondary outcomes .


No adverse effects were noted .


Nebulized pentoxifylline is safe but did not reduce the duration of oxygen supplementation in extremely preterm infants at high risk of BPD .


Dose-ranging studies and large , well-designed clinical trials are required to determine whether the use of nebulized or systemic pentoxifylline as a prophylactic therapy offers small but relevant benefits for prevention of BPD .


Secondhand smoke exposure ( SHSe ) is a significant modifiable risk for respiratory health in children .


Although SHSe is declining overall , it has increased for low-income and minority populations .


Implementation of effective SHSe interventions within community organizations has the potential for significant public health impact .


To evaluate the effectiveness of motivational interviewing ( MI ) delivered in the context of a SHS education reduction initiative within Head Start to reduce preschool children 's SHSe .


A total of @ children enrolled in Baltimore City Head Start whose caregivers reported a smoker living in the home were recruited .


Caregivers were randomized to MI + education or education alone .


Assessments were conducted at baseline , @ , @ , and @ months .


The primary outcome measure was household air nicotine levels measured by passive dosimeters .


Secondary outcomes included child salivary cotinine , self-report of home smoking ban ( HSB ) , and smoking status .


Participants in the MI + education group had significantly lower air nicotine levels ( @ vs. @ mg ) , @ % increase in prevalence of caregiver-reported HSBs , and a @ % decrease in caregiver smokers compared with education-alone group ( all P values < @ ) .


Although group differences in salivary cotinine were not significant , among all families who reported having an HSB , salivary cotinine and air nicotine levels declined in both groups ( P < @ ) .


MI may be effective in community settings to reduce child SHSe .


More research is needed to identify ways to tailor interventions to directly impact child SHSe and to engage more families to make behavioral change .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


Conspicuous differences in participation rates for breast self-examination ( BSE ) , clinical breast examination ( CBE ) , and referral for further investigations have been observed indicating involvement of a number of different factors .


This study analysed determinants for participation in different levels of the breast cancer screening process in Indian females .


An intervention group of @,@ women was interviewed in a breast cancer screening trial in Trivandrum district , India .


In order to assess demographic , socio-economic , reproductive , and cancer-related determinants of participation in BSE , CBE , and referral , uni - and multi-variate logistic regression was employed .


Of the interviewed women , @ % reported practicing BSE , @ % had attended CBE , and @ % of @,@ screen-positives attended referral .


Results showed an influence of various determinants on participation ; women who were currently not married or who had no family history of cancer were significantly less likely to attend the screening process at any level .


Increasing awareness about breast cancer , early detection methods , and the advantages of early diagnoses among women , and their families , as well as health care workers offering social support , could help to increase participation over the entire screening process in India .


Reducing consumption of food away from home is often targeted during pediatric obesity treatment , given the associations with weight status and gain .


However , the effects of this dietary change on weight loss are unknown .


Our aim was to evaluate associations between changes in dietary factors and child anthropometric outcomes after treatment .


It is hypothesized that reduced consumption of food away from home will be associated with improved dietary intake and greater reductions in anthropometric outcomes ( standardized body mass index -LSB- BMI -RSB- and percent body fat ) , and the relationship between food away from home and anthropometric outcomes will be mediated by improved child dietary intake .


We conducted a longitudinal evaluation of associations between dietary changes and child anthropometric outcomes .


Child diet ( three @-hour recalls ) and anthropometric data were collected at baseline and @ weeks .


Participants were @ overweight and obese children ages @ to @ years who completed a @-week family-based behavioral weight-loss treatment as part of a larger multi-site randomized controlled trial conducted in two cohorts between @ and @ ( clinical research trial ) .


Dietary treatment targets during family-based behavioral weight-loss treatment included improving diet quality and reducing food away from home .


The main outcome measures in this study were child relative weight ( standardized BMI ) and body composition ( percent body fat ) .


We performed t tests and bootstrapped single-mediation analyses adjusting for relevant covariates .


As hypothesized , decreased food away from home was associated with improved diet quality and greater reductions in standardized BMI ( P < @ ) and percent body fat ( P < @ ) .


Associations between food away from home and anthropometric outcomes were mediated by changes in diet quality .


Specifically , change in total energy intake and added sugars mediated the association between change in food away from home and standardized BMI , and change in overall diet quality , fiber , added sugars , and added fats mediated the association between change in food away from home and percent body fat .


Including physical activity as a covariate did not significantly impact these findings .


These results suggest that reducing food away from home can be an important behavioral target for affecting positive changes in both diet quality and anthropometric outcomes during treatment .


Music has been employed in various clinical settings to reduce anxiety .


However , meta-analysis has shown music to have little influence on haemodynamic parameters .


This study aimed at investigating the effect of relaxing music on heart rate recovery after exercise .


Twenty-three student volunteers underwent treadmill exercise and were assessed for heart rate recovery and saliva analysis ; comparing exposure to sedative music with exposure to silence during the recovery period immediately following exercise .


No differences were found between music and non-music exposure regarding : heart rate recovery , resting pulse rate , and salivary cortisol .


Music was no different to silence in affecting these physiological measures , which are all associated with anxiety .


Relaxing music unaccompanied by meditation techniques or other such interventions may not have a major role in reducing anxiety in certain experimental settings .


Fatigue is one problem that is seen in high numbers in hemodialysis patients .


Fatigue decreases quality of life by negatively affecting an individual 's daily performance , activities , professional life , relations with family and friends , and treatment process .


This study was carried out to determine the effect of acupressure on the level of fatigue in hemodialysis patients .


The study was conducted as experimental research with an acupressure ( intervention ) group and a control group .


The research , for which an ethics committee 's approval and institutional permission was obtained , was conducted in two central provinces of Turkey , Nevehir and Aksaray , at two hemodialysis centers with similar characteristics .


The research was completed with a total of @ participants ( @ in the intervention group and @ in the control group ) who met the inclusion criteria .


A total of @ acupressure sessions , @ / wk for @ mo , were performed for all participants in the intervention group , as required by the acupressure application protocol , applying acupressure at the Stomach @ ( ST-@ ) , Gallbladder @ ( GB-@ ) , Spleen @ ( SP-@ ) , and Kidney @ ( K-@ ) acupuncture points with a transcutaneous electrical nerve stimulation ( TENS ) acupuncture pen ( XFT-@ acupuncture pen , Shenzhen Xunfegtong Electronics Co , Ltd , Shenzhen , China ) .


A visual analog scale ( VAS ) for fatigue and the Piper Fatigue Scale ( PFS ) were used to evaluate the fatigue level of the participants before and after the acupressure application .


After the acupressure applications for @ mo , the subscale and total fatigue scores for the VAS ( P < @ ) and PFS were lower ( P < @ ) for participants in the intervention group compared to the controls , except for the cognitive subscale on the PFS ( P < @ ) .


The study found that acupressure , applied using an acupuncture pen , was effective in decreasing fatigue in hemodialysis patients .


Based on this result , the current research team suggests that hemodialysis patients and nurses should be informed about acupressure application so as to extend the use of acupressure in reducing fatigue symptoms .


The aim of our study was to measure the volume of gestational sac and amniotic sac in physiological pregnancies and missed abortion .


We wanted to create nomograms for individual weeks of gestation .


Retrospective cohort study .


Institute for the Care of Mother and Child , Prague .


The study randomized @ women after spontaneous conception .


The patients were divided into two groups : women with physiological pregnancy and childbirth in the period ( @ ) , and women with pregnancy terminated by missed abortion .


Both groups were performed measurement volume of gestational and amniotic sac in the first trimester of pregnancy .


Analysis was performed using @D View software applications , and volume calculations were performed using VOCAL ( Virtual Organ Computer Aided anaLysis ) .


We have created the first in the Czech Republic nomograms volumes of gestational and amniotic sac in physiological pregnancies and missed abortion .


We performed a correlation between the size of gestational sac and prosperity pregnancy .


In our study we found no correlation between the volume of gestational sac and the development of the pregnancy .


To evaluate the effect of structured physical activity on sleep-wake behaviors in sedentary community-dwelling elderly adults with mobility limitations .


Multicenter , randomized trial of moderate-intensity physical activity versus health education , with sleep-wake behaviors prespecified as a tertiary outcome over a planned intervention period ranging from @ to @ months .


Lifestyle Interventions and Independence for Elders Study .


Community-dwelling persons aged @ to @ who were initially sedentary and had a Short Physical Performance Battery score less than @ ( N = @,@ ) .


Sleep-wake behaviors were evaluated using the Insomnia Severity Index ( ISI ) ( @ defined insomnia ) , Epworth Sleepiness Scale ( ESS ) ( @ defined daytime drowsiness ) , and Pittsburgh Sleep Quality Index ( PSQI ) ( > @ defined poor sleep quality ) administered at baseline and @ , @ , and @ months .


The randomized groups were similar in terms of baseline demographic variables , including mean age ( @ ) and sex ( @ % female ) .


Structured physical activity resulted in a significantly lower likelihood of having poor sleep quality ( adjusted odds ratios ( aOR ) for PSQI > @ = @ , @ % confidence interval ( CI ) = @-@ @ ) , including fewer new cases ( aOR for PSQI > @ = @ , @ % CI = @-@ @ ) , than health education but not in resolution of prevalent cases ( aOR for PSQI @ = @ , @ % CI = @-@ @ ) .


No significant intervention effects were observed for the ISI or ESS .


Structured physical activity resulted in a lower likelihood of developing poor sleep quality ( PSQI > @ ) over the intervention period than health education but had no effect on prevalent cases of poor sleep quality or on sleep-wake behaviors evaluated using the ISI or ESS .


These results suggest that the benefit of physical activity in this sample was preventive and limited to sleep-wake behaviors evaluated using the PSQI .


The results of preclinical studies suggest that baclofen may be useful in the treatment of stroke patients with persistent hiccups .


This study was aimed to assess the possible efficacy of baclofen for the treatment of persistent hiccups after stroke .


In total , @ stroke patients with persistent hiccups were randomly assigned to receive baclofen ( n = @ ) or a placebo ( n = @ ) in a double-blind , parallel-group trial .


Participants in the baclofen group received @mg baclofen @ times daily for @days .


Participants assigned to the placebo group received @mg placebo @ times daily for @days .


The primary outcome measure was cessation of hiccups .


Secondary outcome measures included efficacy in the two groups and adverse events .


All @ patients completed the study .


The number of patients in whom the hiccups completely stopped was higher in the baclofen group than in the placebo group ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Furthermore , efficacy was higher in the baclofen group than in the placebo group ( P < @ ) .


No serious adverse events were documented in either group .


One case each of mild transient drowsiness and dizziness was present in the baclofen group .


Baclofen was more effective than a placebo for the treatment of persistent hiccups in stroke patients .


A cardiac arrest can lead to hypoxic-ischaemic brain injury which can result in cognitive and emotional impairments and may negatively affect daily functioning , participation in society and quality of life .


Furthermore , the impact on the family of the patient can be high .


We designed an intervention called ` Stand still , and move on ' , which is a concise , individualised , semi-structured intervention for survivors of cardiac arrest and their caregivers , consisting of between one and six face-to-face consultations provided by a trained nurse .


The intervention is directed at early detection of cognitive and emotional problems , provision of information , promotion of self-management and referral to specialised care if necessary .


The effectiveness of the intervention is being examined in a randomised controlled trial -LSB- ISRCTN@ -RSB- .


Alongside this trial we performed a process evaluation which aims to investigate the feasibility of the intervention by assessing : @ ) the attendance and dose delivered ; @ ) performance according to protocol ; and @ ) the opinion of patients , caregivers and nurses on the intervention .


Participants of this process evaluation were @ patients allocated to the intervention group of the RCT , their @ caregivers , and six nurses who conducted the intervention .


Measurement instruments used were evaluation forms for patients and caregivers , registration and evaluation forms for nurses , and semi-structured interviews with nurses .


Seventy-nine of the patients ( @ % ) allocated to the intervention group and @ caregivers ( @ % ) participated in the intervention .


The mean ( SD ) number of consultations per patient was @ ( @ ) , and most consultations were conducted at the patients ' home .


The intervention was performed largely according to protocol , except that the intervention usually started later than intended , consultations were longer than expected , and the topic of self-management was not regularly addressed .


Patients marked the quality of the intervention with a mean score of @ and the performance of the nurse with an @ out of ten .


Overall , the intervention was positively evaluated by patients , caregivers and nurses .


The intervention ` Stand still , and move on ' is a promising intervention which was performed largely according to protocol and seems feasible for implementation after some adaptations , if it is found to be effective .


To investigate the efficacy of bupivacaine-soaked spongostan in cesarean section wound for postoperative anxiety level , satisfaction and early postpartum depression rate .


A total of @ women , American Society of Anesthesiologists physical status I-II , scheduled to undergo general anesthesia and elective cesarean section were recruited and randomized into a study group ( n = @ ) or a control group ( n = @ ) .


In the spongostan group , bupivacaine-soaked spongostan was placed in the cesarean section wound .


The control group did not receive spongostan , but only general postoperative care .


Maternal health was assessed using a visual analog scale for satisfaction , a visual analog scale for anxiety and the Edinburgh Postpartum Depression Scale for postpartum depression .


Also , first breast-feeding time , first mobilization time and opioid consumption were recorded and compared .


The anxiety level of the spongostan group was lower than that of the control group and the difference was statistically significant at all time intervals ( @ , @ , @ , @ , @ , @ , @ and @ h , p < @ , respectively ) .


Postpartum depression rate again was significantly lower in the spongostan group both on postoperative day @ and day @ ( p @ ) .


All satisfaction scores were significantly higher in the spongostan group than in the control group ( p < @ ) .


Additionally , first breast-feeding and first mobilization times were significantly shorter and opioid consumption was lower in the spongostan group ( p < @ ) .


Placement of bupivacaine-soaked spongostan into the cesarean section wound resulted in decreased postoperative anxiety level and postpartum depression rate and increased satisfaction .


Chronic hepatitis C treatment for prior non-responders to peginterferon ( PegIFN ) / ribavirin remains suboptimal .


The MATTERHORN study evaluated regimens containing ritonavir-boosted danoprevir ( danoprevir/r ) in prior PegIFN alfa/ribavirin non-responders .


Prior partial responders ( N = @ ) were randomized to @ weeks of twice-daily danoprevir/r @/@mg , mericitabine @ mg and ribavirin @/@ mg ( IFN-free ) ; danoprevir/r plus PegIFN alfa-@a / ribavirin ( triple ) ; or danoprevir/r , mericitabine and PegIFN alfa-@a / ribavirin ( Quad ) .


Prior null responders ( N = @ ) were randomized to @ weeks of IFN-free therapy , or quad alone ( Quad @ ) or quad plus @-weeks of PegIFN alfa-@a / ribavirin ( Quad @ ) .


The primary endpoint was sustained virological response ( HCV RNA < @ IU/ml ) @ weeks after end-of-treatment ( SVR@ ) .


Due to high relapse rates , genotype ( G ) @a patients in IFN-free arms were offered additional PegIFN alfa-@a / ribavirin .


Among prior partial responders , SVR@ rates were @ % , @ % , and @ % , in the IFN-free , Triple and Quad arms , respectively ; among prior null responders , SVR@ rates were @ % , @ % , and @ % respectively .


Relapse rates were lower and SVR@ rates higher in G@b-infected than G@a-infected patients .


SVR@ rates in G@a and G@b patients randomized to Quad were @ % and @ % , respectively , in the partial Quad arm , and @ % and @ % , respectively , in the null Quad @ arm .


Treatment failure was associated with resistance to danoprevir , but not to mericitabine , and was more common in G@a infected patients .


Treatment was well-tolerated .


Danoprevir/r , mericitabine plus PegIFN alfa-@a / ribavirin was well-tolerated and produced high overall SVR@ rates in prior partial and null responders to PegIFN alfa/ribavirin .


In contrast , IFN-free regimens were associated with unacceptably high relapse rates .


Long chain omega-@ polyunsaturated fatty acids ( LC n-@ PUFA ) such as EPA and DHA have been shown to possess beneficial health effects , and it is believed that many of their effects are mediated by their oxygenated products ( oxylipins ) .


Recently , we have shown that serum levels of several hydroxy , epoxy , and dihydroxy FAs are dependent on the individual status of the parent FAs in a cohort of normo - and hyperlipidemic subjects .


So far , the effect of an increased dietary LC n-@ PUFA intake on hydroxy , epoxy , and dihydroxy FA levels has not been investigated in subjects with mild combined hyperlipidemia .


In the present study , we compared oxylipin patterns of @ hyperlipidemic ( cholesterol > @mg/dl ; triglyceride > @mg/ml ) and @ normolipidemic men in response to twelve weeks of LC n-@ PUFA intake ( @ g DHA and @ g EPA ) .


Levels of @ free hydroxy , epoxy and dihydroxy FAs were analyzed in serum by LC-MS .


Additionally , oxylipin levels were compared with their parent PUFA levels in erythrocyte membranes ; a biomarker for the individual PUFA status .


Differences in the oxylipin pattern between normo - and hyperlipidemic subjects were minor before and after treatment .


In all subjects , levels of EPA-derived oxylipins ( @-@pM ) were considerably elevated after LC n-@ PUFA intake ( @-@ % ) , the increase of DHA-derived oxylipins ( @-@pM ) was less pronounced ( @-@ % ) .


The relative change of EPA in erythrocyte membranes is strongly correlated ( r@ @ ; p < @ ) with the relative change of corresponding epoxy and dihydroxy FA serum levels .


The effect on arachidonic acid ( AA ) - derived oxylipin levels ( @-@ ,@ pM ) was inconsistent .


The dietary LC PUFA composition has a direct influence on the endogenous oxylipin profile , including several highly biological active EPA - and DHA-derived lipid mediators .


The shift in oxylipin pattern appears to be dependent on the initial LC PUFA status particularly for EPA .


The finding that also levels of other oxylipins derived from ALA , LA or AA are modified by LC n-@ PUFA intake might suggest that at least some of the effects of EPA and DHA could be mediated by a shift in the entire oxylipin profile .


A small subset of HIV-positive adults have low HIV RNA in the absence of therapy , sometimes for years .


Clinical factors associated with low HIV RNA in early infection have not been well defined .


We assessed factors associated with low plasma HIV RNA level at study entry in the Strategic Timing of AntiRetroviral Treatment ( START ) trial .


All START participants had a baseline HIV RNA assessment within @ days prior to randomization .


The key covariables considered for this analysis were race , and hepatitis B virus ( HBV ) and hepatitis C virus ( HCV ) status .


We assessed factors associated with HIV RNA @ and @ HIV-@ RNA copies/mL using logistic regression .


Because of the strong association between region of randomization and baseline low HIV RNA , analyses were stratified by region .


We found that , of @ eligible participants randomized in START with a baseline HIV RNA assessment , @ ( @ % ) had HIV RNA @copies/mL at baseline , and a further @ ( @ % ) between @ and @copies/mL .


We found that HIV exposure routes other than male homosexual contact , higher high-density lipoprotein ( HDL ) cholesterol levels , higher CD@ cell counts , and higher CD@ : CD@ ratio were associated with increased odds of low HIV RNA .


HCV antibody positivity was borderline statistically significantly associated with low HIV RNA .


Race and HBV surface antigen positivity were not significantly associated with low HIV RNA .


In a modern cohort of individuals with early untreated HIV infection , we found that HIV exposure routes other than male homosexual contact and higher HDL cholesterol were associated with increased odds of low HIV RNA .


To compare the efficacy and toxicity of chemotherapy under the guidance of molecular markers and with vinorelbine in elderly patients with epidermal growth factor receptor ( EGFR ) wild-type advanced non-small cell lung cancer ( NSCLC ) .


A total of @ elderly patients with pathologically-confirmed advanced NSCLC with EGFR wild-type were recruited between June @ to October @ .


There were @ males and @ females , aging from @ to @ years .


They were divided randomly into @ groups according to the proportion of @ : @ by SPSS @ software .


The study group received chemotherapy ( cisplatin , gemcitabine , paclitaxel , and pemetrexed ) under the guidance of molecular markers ( excision repair cross-complementing @ ERCC@ , ribonucleotide reductase M@ RRM@ , Class III beta-tubulin , thymidylate synthetase TS ) .


The control group received vinorelbine @ mg/m ( @ ) days @ and @ with @ days as a cycle .


The progression-free survival ( PFS ) of the study group and the control group was @ months ( @ % CI : @-@ @ ) and @ months ( @ % CI : @-@ @ ) respectively , the difference being statistically significant ( ( @ ) = @ , P = @ ) .


The objective response rate ( ORR ) was @ % ( @/@ ) and @ % ( @/@ ) ( ( @ ) = @ , P = @ ) , the disease control rate ( DCR ) was @ % ( @/@ ) and @ % ( @/@ ) ( ( @ ) = @ , P = @ ) , and the median overall survival ( OS ) was @ months and @ months ( ( @ ) = @ , P = @ ) , respectively ; the differences being not significant .


Adverse effects were similar between the study group and the control group .


The most commonly seen adverse events were hematological toxicity , nausea , vomiting , fatigue , alopecia , joint and muscle pain .


Most of the toxicity was of grade I and grade II .


There was no treatment-related death .


The PFS was prolonged in elderly patients with EGFR wild-type advanced NSCLC under the guidance of molecular markers , but there was no improvement in ORR , DCR and OS .


Further studies are needed to evaluate the clinical significance of this treatment modality .


To investigate the modulatory effects that dynamic hyperinflation ( DH ) , defined as a reduction in inspiratory capacity ( IC ) , has on exercise tolerance after bronchodilator in patients with COPD .


An experimental , randomized study involving @ COPD patients without severe hypoxemia .


At baseline , the patients underwent clinical assessment , spirometry , and incremental cardiopulmonary exercise testing ( CPET ) .


On two subsequent visits , the patients were randomized to receive a combination of inhaled fenoterol/ipratropium or placebo .


All patients then underwent spirometry and submaximal CPET at constant speed up to the limit of tolerance ( Tlim ) .


The patients who showed IC ( peak-rest ) < @ were considered to present with DH ( DH + ) .


In this sample , @ patients ( @ % ) had DH .


The DH + patients had higher airflow obstruction and lower Tlim than did the patients without DH ( DH - ) .


Despite equivalent improvement in FEV@ after bronchodilator , the DH - group showed higher IC ( bronchodilator-placebo ) at rest in relation to the DH + group ( p < @ ) .


However , this was not found in relation to IC at peak exercise between DH + and DH - groups ( @ @ L vs. @ @ L , p > @ ) .


In addition , both groups showed similar improvements in Tlim after bronchodilator ( median -LSB- interquartile range -RSB- : @ % -LSB- @-@ % -RSB- vs. @ % -LSB- @-@ % -RSB- ; p > @ ) .


Improvement in TLim was associated with an increase in IC at rest after bronchodilator in HD - patients with COPD .


However , even without that improvement , COPD patients can present with greater exercise tolerance after bronchodilator provided that they develop DH during exercise .


Acute otitis media ( AOM ) is a common childhood illness and the leading indication for antibiotic prescriptions for US children .


Xylitol , a naturally occurring sugar alcohol , can reduce AOM when given @ times per day as a gum or syrup , but a more convenient dosing regimen is needed for widespread adoption .


We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of @ g @ times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children @ months through @ years of age .


A total of @ subjects were enrolled , with @ allocated to xylitol and @ to placebo .


In the primary analysis of time to first clinically diagnosed AOM episode , the hazard ratio for xylitol versus placebo recipients was @ ( @ % confidence interval -LSB- CI -RSB- @ to @ ) .


In secondary analyses , the incidence of AOM was @ episodes per @ days in the xylitol group versus @ in the placebo group ( difference @ ; @ % CI -@ to @ ) ; total antibiotic use was @ days per @ days in the xylitol group versus @ in the placebo group ( difference @ ; @ % CI -@ to @ ) .


The lack of effectiveness was not explained by nonadherence to treatment , as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was @ ( @ % CI @ to @ ) .


Viscous xylitol solution in a dose of @ g @ times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children .


To compare efficacy and safety of thromboprophylaxis with semuloparin started postoperatively versus enoxaparin started preoperatively in major abdominal surgery .


Venous thromboembolism is an important complication following major abdominal surgery .


Semuloparin is a novel ultra-low-molecular-weight heparin with high antifactor Xa and minimal antifactor IIa activity .


In this double-blind noninferiority trial , adult patients undergoing major abdominal or pelvic operation under general anesthesia lasting more than @ minutes were assigned to either daily enoxaparin @ mg commenced preoperatively or daily semuloparin @ mg commenced postoperatively , for @ to @ days .


Patients underwent bilateral leg venography between @ and @ days postsurgery .


The primary efficacy end point was the composite of any deep vein thrombosis , nonfatal pulmonary embolism , or all-cause death .


The primary safety outcome was bleeding .


Both were independently adjudicated .


In total , @ patients were randomized ; @ ( @ in the enoxaparin and @ in the semuloparin groups ) were evaluable for the primary efficacy end point , which occurred in @ patients ( @ % ) in the semuloparin group and @ patients ( @ % ) in the enoxaparin group -LSB- odds ratio ( OR ) = @ , @ % confidence interval ( CI ) : @-@ @ -RSB- .


On the basis of a noninferiority margin of @ , postoperative semuloparin did not demonstrate noninferiority to preoperative enoxaparin .


Major bleeding occurred in @ of @ patients ( @ % ) in the semuloparin group and @ of @ patients ( @ % ) in the enoxaparin group ( OR = @ , @ % CI : @-@ @ ) .


Semuloparin commenced postoperatively did not demonstrate noninferiority to enoxaparin initiated preoperatively for thromboprophylaxis after major abdominal surgery .


Study registered with clinicaltrials.gov : NCT@ .


To compare visual outcome , higher-order aberrations , and corneal asphericity ( Q value ) between wavefront-guided and aspheric LASIK for myopia and myopic astigmatism .


Forty patients were randomly selected to receive wavefront-guided LASIK ( wavefront-guided group ) or aspheric LASIK ( aspheric group ) ( @ eyes of @ patients in each group ) using the Technolas @z excimer laser platform ( Bausch & Lomb , Rochester , NY ) .


Flaps were created using the Zyoptix XP microkeratome ( Bausch & Lomb ) .


Preoperative and postoperative evaluation included uncorrected distance visual acuity ( UDVA ) , corneal topography , wavefront aberrometry , and contrast sensitivity .


Minimum follow-up period was @ months .


At @ months postoperatively , the aspheric group had significantly better UDVA ( logMAR @ @ -LSB- Snellen @/@ -RSB- -LSB- range : -@ to @ -RSB- ) and lower mean residual spherical error ( +@ @ diopters -LSB- D -RSB- -LSB- range : -@ to @ D -RSB- ) than the wavefront-guided group ( logMAR UDVA @ @ -LSB- range : -@ to @ -RSB- ; MRSE -@ @ D -LSB- range : -@ to @ D -RSB- ) ( P = @ and < @ , respectively ) .


Mean change in higher-order aberration root mean square at @ months postoperatively ( @-mm pupil ) was @ @ m after aspheric LASIK and @ @ m after wavefront-guided LASIK ( P = @ ) .


Aspheric LASIK induced minimal change in spherical aberrations postoperatively ( @ @ m , P = @ ) , unlike wavefront-guided LASIK ( @ @ m , P < @ ) .


Change in Q value was significantly less in the aspheric group ( @ @ ) than the wavefront-guided group ( @ @ ) ( P < @ ) .


The aspheric group had significant improvement in contrast sensitivity at all spatial frequencies ( P < @ ) , whereas the wavefront-guided group showed a slight decrease at higher spatial frequency ( @ cycles per degree ) .


Aspheric LASIK induced significantly less change in higher-order aberrations and maintained corneal asphericity better than wavefront-guided LASIK .


The visual outcome and contrast sensitivity was better in the aspheric group at @ months postoperatively .


Hyperparathyroidism occurs frequently in X-linked hypophosphatemia ( XLH ) and may exacerbate phosphaturia , potentially affecting skeletal abnormalities .


The objective of the study was to suppress elevated PTH levels in XLH patients .


This was a prospective , randomized , placebo-controlled , double-blind , @-year trial of paricalcitol , with outcomes measured at entry and @ year later .


PATIENTS were recruited from the investigators ' clinics or referred from throughout the United States .


Data were collected in an in-patient hospital research unit .


Subjects with a clinical diagnosis of XLH and hyperparathyroidism were offered participation and were eligible if they were @ years old or older and not pregnant , and their serum calcium level was less than @ mg/dL , their @-hydroxyvitamin D level was @ ng/mL or greater , and their creatinine level was @ mg/dL or less .


The intervention for this study was the use of paricalcitol or placebo for @ year .


Determined prior to trial onset was the change in PTH area under the curve .


Secondary outcomes included renal phosphate threshold per glomerular filtration rate , serum phosphorus , serum alkaline phosphatase activity , and ( @m ) Tc-methylenediphosphonate bone scans .


PTH area under the curve decreased @ % with paricalcitol , differing ( P = @ ) from the @ % increase with placebo .


The renal phosphate threshold per glomerular filtration rate increased @ % with paricalcitol and decreased @ % with placebo ( P = @ ) .


Serum phosphorus increased @ % with paricalcitol but did not differ from placebo .


Paricalcitol decreased alkaline phosphatase activity in adults by @ % ( no change with placebo , P = @ ) .


Bone scans improved in @ of @ paricalcitol subjects , whereas no placebo-treated subject improved .


Hypercalciuria developed in six paricalcitol subjects and persisted from baseline in one placebo subject .


Suppression of PTH may be a useful strategy for skeletal improvement in XLH patients with hyperparathyroidism , and paricalcitol appears to be an effective adjunct to standard therapy in this setting .


Although paricalcitol was well tolerated , urinary calcium and serum calcium and creatinine should be monitored closely with its use .


Whether the type of dietary fat could alter cardiometabolic responses to a hypercaloric diet is unknown .


In addition , subclinical cardiometabolic consequences of moderate weight gain require further study .


In a @-week , double-blind , parallel-group , randomized controlled trial , @ healthy , lean individuals ( mean age of @ ) consumed muffins ( @ % of energy -LSB- % E -RSB- from fat and @ % E refined carbohydrates ) providing @ kcal/day added to their habitual diets .


All muffins had identical contents , except for type of fat ; sunflower oil rich in polyunsaturated fatty acids ( PUFA diet ) or palm oil rich in saturated fatty acids ( SFA diet ) .


Despite comparable weight gain in the @ groups , total : high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein : HDL cholesterol , and apolipoprotein B : AI ratios decreased during the PUFA versus the SFA diet ( -@ versus +@ , -@ versus +@ , and -@ versus +@ , P = @ , P = @ , and P = @ for between-group differences ) , whereas no significant differences were observed for other cardiometabolic risk markers .


In the whole group ( ie , independently of fat type ) , body weight increased ( +@ % , P < @ ) together with increased plasma proinsulin ( +@ % , P = @ ) , insulin ( +@ % , P = @ ) , proprotein convertase subtilisin/kexin type @ , ( +@ % , P = @ ) fibroblast growth factor-@ ( +@ % , P = @ ) , endothelial markers vascular cell adhesion molecule-@ , intercellular adhesion molecule-@ , and E-selectin ( +@ , +@ , and +@ % , respectively , P < @ for all ) , whereas nonesterified fatty acids decreased ( -@ % , P = @ ) .


Excess energy from PUFA versus SFA reduces atherogenic lipoproteins .


Modest weight gain in young individuals induces hyperproinsulinemia and increases biomarkers of endothelial dysfunction , effects that may be partly outweighed by the lipid-lowering effects of PUFA .


To characterize the variability in exposure and metabolic effect of insulin glargine @U/ml ( Gla-@ ) at steady state in people with type @ diabetes ( T@DM ) .


A total of @ participants with T@DM underwent two @-h euglycaemic clamps in steady-state conditions after six once-daily administrations of @ U/kg Gla-@ in a double-blind , randomized , two-treatment , two-period , crossover clamp study .


Participants were randomized to receive Gla-@ as a standard cartridge formulation in the first treatment period , and as a formulation with enhanced stability through polysorbate-@ addition in the second treatment period , or vice versa .


This design allowed the assessment of bioequivalence between formulations and , subsequently , within - and between-day variability .


The cumulative exposure and effect of Gla-@ developed linearly over @h , and were evenly distributed across @ - and @-h intervals .


Diurnal fluctuation in exposure ( within-day variability ) was low ; the peak-to-trough ratio of insulin concentration profiles was < @ , and both the swing and peak-to-trough fluctuation were < @ .


Day-to-day reproducibility of exposure was high : the between-day within-subject coefficients of variation for total systemic exposure ( area under the serum insulin glargine concentration time curve from time @ to @h after dosing ) and maximum insulin concentration were @ % -LSB- @ % confidence interval ( CI ) @-@ -RSB- and @ % ( @ % CI @-@ ) , respectively .


Reproducibility of the metabolic effect was lower than that of exposure .


Gla-@ provides predictable , evenly distributed @-h coverage as a result of low fluctuation and high reproducibility in insulin exposure , and appears suitable for effective basal insulin use .


Echocardiography-guided ( EG ) lead placement at the site of latest left ventricular ( LV ) mechanical activation improves outcome in patients receiving a cardiac resynchronization therapy ( CRT ) defibrillator ( D ) .


The purpose of this study is to examine whether a strategy of EG LV lead placement equally improves outcome in CRT recipients with wide ( @ ms ) versus intermediate ( @-@ ms ) QRS duration .


Patients treated with a CRT-D in the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region ( STARTER ) prospective , randomized trial ( @ EG strategy and @ routine strategy ) were followed to the endpoint of death or first appropriate CRT-D therapy .


Of the patients enrolled in STARTER , @ had QRS@ ms and @ had @ < QRS@ ms.


Over a mean follow-up period of @ years , @ ( @ % ) patients died and @ ( @ % ) received appropriate CRT-D therapy .


Compared to patients with QRS@ ms , patients with intermediate QRS had meaningfully worse survival free from ICD therapy ( HR = @ , p = @ ) .


CRT-D therapy-free survival was significantly worse in patients with intermediate QRS duration randomized to the routine LV lead placement strategy , compared to patients with intermediate QRS duration randomized to the EG LV lead placement strategy or patients with wide QRS duration regardless of LV implantation strategy ( HR = @ , @ % confidence interval = @-@ @ , P = @ ) .


This finding was independent in type of cardiomyopathy .


A strategy of EG LV lead placement improves survival free from defibrillator therapy in patients with QRS between @-@ ms to levels comparable to those of patients with QRS@ ms.


After traumatic brain injury ( TBI ) , catecholamines ( CAs ) may be needed to maintain adequate cerebral perfusion pressure ( CPP ) , but there are no recommended alternative vasopressor therapies .


This is an interim report of the first study to test the hypothesis that arginine vasopressin ( AVP ) is a safe and effective alternative to CAs for the management of CPP in patients with severe TBI .


Since @ , all TBI patients requiring intracranial pressure monitoring at this Level @ trauma center have been eligible for a randomized trial to receive either CA or AVP if vasopressors were required to maintain CPP greater than @ mm Hg .


To date , @ patients have been consented and randomized .


Demographics , vital signs , and laboratory values were similar .


As treated , @ required no vasopressors and were the least severely injured group with the best outcomes .


Twenty-three patients received CA ( @ % levophed , @ % dopamine , @ % phenylephrine ) and @ patients received AVP .


The two vasopressor groups had similar demographics , but Injury Severity Score ( ISS ) and fluid requirements on intensive care unit Day @ were worse in the AVP versus the CA groups ( all p < @ ) before treatment .


These differences indicate more severe injury with accompanying hemodynamic instability .


Nevertheless , adverse events were not increased with AVP versus CA .


Trends favored AVP versus CA , but no apparent differences were statistically significant at this interim point .


There was no difference in mortality rates between CA and AVP .


These preliminary results suggest that AVP is a safe and effective alternative to CA for the management of CPP after TBI and support the continued investigation and use of AVP when vasopressors are required for CPP management in TBI patients .


Therapeutic study , level II .


Artemisinin-based combination therapy ( ACT ) is widely recommended as first-line therapy for uncomplicated Plasmodium falciparum malaria worldwide .


Artemisinin resistance has now been reported in Southeast Asia with a clinical phenotype manifested by slow parasite clearance .


Although there are no reliable reports of artemisinin resistance in Africa , there is a need to better understand the dynamics of parasite clearance in African children treated with ACT in order to better detect the emergence of artemisinin resistance .


Data from a cohort of Ugandan children four to five years old , enrolled in a longitudinal , randomized , clinical trial comparing two leading ACT , artemether-lumefantrine ( AL ) and dihydroartemisinin-piperaquine ( DP ) , were analysed .


For all episodes of uncomplicated P. falciparum malaria over a @-month period , daily blood smears were performed for three days following the initiation of therapy .


Associations between pre-treatment variables of interest and persistent parasitaemia were estimated using multivariate , generalized , estimating equations with adjustment for repeated measures in the same patient .


A total of @ children were included , resulting in @ episodes of malaria treated with AL and @ episodes treated with DP .


The prevalence of parasitaemia on days @ , @ , and @ following initiation of therapy was @ , @ and @ % in those treated with AL , and @ , @ and @ % in those treated with DP .


Independent risk factors for persistent parasitaemia on day @ included treatment with AL vs DP ( RR = @ , @ % CI @-@ @ , p < @ ) , having a temperature @ C vs < @ C ( RR = @ , @ % CI @-@ @ , p = @ ) and having a parasite density > @,@ / L vs < @,@ / L ( RR = @ , @ % CI @-@ @ , p < @ ) .


Independent risk factors for having persistent parasitaemia on day @ included elevated temperature , higher parasite density , and being HIV infected .


Among Ugandan children , parasite clearance following treatment with AL or DP was excellent with only one of @ patients tested having a positive blood slide three days after initiation of therapy .


The type of ACT given , pre-treatment temperature , pre-treatment parasite density and HIV status were associated with differences in persistent parasitaemia , one or two days following therapy .


Understanding the nature and time course of the pharmacodynamic effects of attention-deficit/hyperactivity disorder ( ADHD ) medications is useful .


The Cognitive Drug Research Computerized Battery of Tests ( CDR-CBT ) is a @-min battery of ten standardized , validated neuropsychometric tasks .


This pilot study examined the sensitivity and responsiveness of the CDR-CBT for assessing cognitive function in adults with ADHD prior to and up to @ h postdose during treatment with lisdexamfetamine dimesylate ( LDX ) or mixed amphetamine salts immediate release ( MAS-IR ; various generics available ) .


This was a double-blind three-period crossover study .


Participants received LDX @ mg/day , MAS-IR @ mg/day , and placebo ( ~ @ a.m. ) for @ days each in randomized order .


CDR-CBT was administered on day @ of period @ and day @ of each period at scheduled times between -@ ( predose ) and @ h postdose .


Composite power of attention ( PoA ) score ( sum of simple reaction time , choice reaction time , and digit vigilance speed ) was the primary outcome measure .


The Conners ' Adult ADHD Rating Scales-Self-Report : Short Version ( CAARS-S : S ) was administered at baseline and on day @ of period @ , and days @ and @ of each treatment period .


Tertiary outcomes included CDR-CBT composite continuity of attention scores , its component task scores , cognitive reaction time , and response variability scores .


No inferential statistical comparisons were conducted .


Safety assessments included adverse events ( AEs ) and vital signs .


This analysis included @ participants ( mean age @ years ) ; one withdrew because of AEs .


Mean pretreatment PoA scores were @-@ @ ms , scores commensurate with a normative age of > @ years .


Maximum reductions in PoA scores with LDX and MAS-IR occurred at @ h postdose at day @ ( least squares mean difference -LSB- @ % CI -RSB- of -@ -LSB- -@ to -@ -RSB- and -@ -LSB- -@ to @ -RSB- ms vs. placebo , respectively ) .


CAARS-S : S scores were unchanged with LDX and MAS-IR ( vs. placebo ) at all postdose timepoints .


Tertiary attention-related CDR-CBT outcomes were sensitive to LDX and MAS-IR ( vs. placebo ) .


Treatment-emergent AEs and vital signs were consistent with previous studies in adult ADHD .


In adults with ADHD , PoA scores indicated impaired attention at baseline and response to treatment with LDX and MAS-IR ( vs. placebo ) , demonstrating value for measuring the time course of pharmacologic treatment effects .


To evaluate approximal caries increment among @ - to @-year-olds in a low caries prevalence area in Sweden after a @-year school-based fluoride ( F ) varnish programme with Bifluorid @ and Duraphat .


The design was a RCT study with @ adolescents , divided into following four groups : Group @ Bifluorid @ two applications/year ; Group @ Duraphat two applications/year ; Group @ Bifluorid @ four applications/year and Group @ no F varnish at school .


@ children ( @ % ) completed the study .


Approximal caries was registered on bitewing radiographs .