A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death , major amputation , and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study .


All patients will be followed for 5 years .


A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA .


The rationale and design of the IN.PACT DEEP Trial are discussed .


IN.PACT DEEP is a milestone , prospective , randomized , robust , independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology , the IA-DEB , compared to PTA .


It will assess the overall impact on infrapopliteal artery patency , limb salvage , wound healing , pain control , QoL , and patient mobility .


The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014 .


NCT00941733 .


To investigate the efficacy and safety of adjusting the doses of diuretics of different time in the treatment of advanced schistosomiasis ascites .


A total of 80 advanced schistosomiasis patients with ascites were randomly divided into an observation group and a control group ( 40 cases each ) .


The patients in the observation group received spironolactone and furosemide , and the first doses were 100 mg/d and 40 mg/d , respectively .


If the efficacy was poor , according to the first doses of the standard increments once every four days , the doses gradually increased to the maximum doses of spironolactone 400 mg/d and furosemide 160 mg/d , respectively .


The patients in the control group received spironolactone and furosemide , and the first doses were the same as those of the observation group .


If the efficacy was poor , according to the first doses of the standard increments once every seven days , the doses gradually increased to the maximum doses as those of the observation group .


Other conventional treatments were the same in both groups .


In both groups , the reductions of the total amount of the weight were ( 5.62 + / - 1.28 ) kg and ( 5.42 + / - 1.37 ) kg respectively ; the time of efficacy beginning was ( 3.84 + / - 2.36 ) days and ( 4.65 + / - 2.86 ) days respectively ; the average daily amounts of weight loss were ( 0.41 + / - 0.16 ) kg and ( 0.35 + / - 0.11 ) kg respectively ; the efficient rates were 95 % and 92.5 % respectively ; and there were no significant differences between the two group ( all P > 0.05 ) .


However , the time of reduction from moderate ascites to mild ascites was ( 10.70 + / - 3.01 ) days ( 6-20 days ) in the observation group and the time was ( 14.75 + / - 5.62 ) days ( 7-30 days ) in the control group ( u = 3.876 , P < 0.01 ) .


The therapy of diuretic doses adjusted by a four-day cycle is more useful for advanced schistosomiasis patients with ascites .


Preclinical studies suggest that stress potentiates cue-induced cocaine seeking and that this effect is more pronounced in females .


These findings have not been characterized in clinical populations .


The objectives of this study were to examine the impact a pharmacological stressor , alpha-2 adrenergic receptor antagonist yohimbine , on the subjective , endocrine , and physiologic responses to drug-paired cues cocaine-dependent men and women .


In a double-blind placebo-controlled cross-over study , cocaine-dependent men ( n = 32 ) , cocaine-dependent women ( n = 30 ) , control men ( n = 32 ) , and control women ( n = 25 ) received either yohimbine or placebo prior to two cocaine cue exposure sessions .


Yohimbine increased ratings of anxiety both before ( p < 0.001 ) and after ( p = 0.035 ) cues , and the post-cue increase in anxiety was more pronounced in women ( p = 0.001 ) .


Yohimbine also significantly increased craving , compared with placebo ( p < 0.05 ) , following the cue presentation , and this effect was greater in women than men ( gender by treatment interaction ; p = 0.006 ) .


Yohimbine also increased salivary cortisol ( p < 0.001 ) and dehydroepiandrosterone ( p = 0.003 ) levels , regardless of diagnostic group .


Women had a significantly greater heart rate response following yohimbine as compared with men ( p < 0.001 ) .


Stress may increase the salience of cocaine cues for cocaine-dependent women as compared with men .


This suggests gender differences in vulnerability to craving and relapse under stressful conditions .


The effects of nutritional management among other intervention components have not been examined for hip-fractured elderly persons with poor nutritional status .


Accordingly , this study explored the intervention effects of an in-home program using a comprehensive care model that included a nutrition-management component on recovery of hip-fractured older persons with poor nutritional status at hospital discharge .


A secondary analysis of data from a randomized controlled trial with 24-month follow-up .


A 3000-bed medical center in northern Taiwan .


Subjects were included only if they had `` poor nutritional status '' at hospital discharge , including those at risk for malnutrition or malnourished .


The subsample included 80 subjects with poor nutritional status in the comprehensive care group , 87 in the interdisciplinary care group , and 85 in the usual care group .


The 3 care models were usual care , interdisciplinary care , and comprehensive care .


Usual care provided no in-home care , interdisciplinary care provided 4 months of in-home rehabilitation , and comprehensive care included management of depressive symptoms , falls , and nutrition as well as 1 year of in-home rehabilitation .


Data were collected on nutritional status and physical functions , including range of motion , muscle power , proprioception , balance and functional independence , and analyzed using a generalized estimating equation approach .


We also compared patients ' baseline characteristics : demographic characteristics , type of surgery , comorbidities , length of hospital stay , cognitive function , and depression .


Patients with poor nutritional status who received comprehensive care were 1.67 times ( 95 % confidence interval 1.06-2 .61 ) more likely to recover their nutritional status than those who received interdisciplinary and usual care .


Furthermore , the comprehensive care model improved the functional independence and balance of patients who recovered their nutritional status over the first year following discharge , but not of those who had not yet recovered .


An in-home program using the comprehensive care model with a nutritional component effectively improved the nutritional status of hip-fractured patients with poor nutrition .


This comprehensive care intervention more effectively improved recovery of functional independence and balance for patients with recovered nutritional status .


To determine the effect of vaginal progesterone as luteal support on pregnancy outcomes in infertile patients who undergo ovulation induction with gonadotropins and intrauterine insemination ( IUI ) .


Prospective randomized trial .


Tertiary referral center .


About 398 patients with primary infertility were treated during 893 ovarian stimulation and IUI cycles from February 2010 to September 2012 .


All patients underwent ovarian stimulation with gonadotropins combined with IUI .


Patients in the supported group received vaginal micronized progesterone capsules 200mg once daily from the day after insemination until next menstruation or continuing for up to 8 weeks of pregnancy .


Women allocated in the control group did not receive luteal phase support .


Livebirth rate , clinical pregnancy rate and early miscarriage rate per cycle .


Of the 893 cycles , a total of 111 clinical pregnancies occurred .


There were no significant differences between supported with progesterone and unsupported cycle in terms of livebirth rate ( 10.2 % versus 8.3 % , respectively , with a p value = 0.874 ) and clinical pregnancy rate ( 13.8 % compared with 11.0 % in unsupported cycle with a p value = 0.248 ) .


An early miscarriage rate of 3.6 % was observed in the supported cycles and 2.7 % in the unsupported cycles , with no significant differences between the groups ( p value = 0.874 ) .


In infertile patients treated with mildly ovarian stimulation with recombinant gonadotropins and IUI , luteal phase support with vaginal progesterone is not associated with higher livebirth rate or clinical pregnancy rate compared with patients who did not receive any luteal phase support .


Post-burn hyperglycemia leads to graft failure , multiple organ failure , and death .


A hyperinsulinemic-euglycemic clamp is used to keep serum glucose between 60 and 110 mg/dL .


Because of frequent hypoglycemic episodes , a less-stringent sliding scale insulin protocol is used to maintain serum glucose levels between 80 and 160 mg/dL after elevations > 180 mg/dL .


We randomized pediatric patients with massive burns into 2 groups , patients receiving sliding scale insulin to lower blood glucose levels ( n = 145 ) and those receiving no insulin ( n = 98 ) , to determine the differences in morbidity and mortality .


Patients 0 to 18 years old with burns covering 30 % of the total body surface area and not randomized to receive anabolic agents were included in this study .


End points included glucose levels , infections , resting energy expenditure , lean body mass , bone mineral content , fat mass , muscle strength , and serum inflammatory cytokines , hormones , and liver enzymes .


Maximal glucose levels occurred within 6 days of burn injury .


Blood glucose levels were age dependent , with older children requiring more insulin ( p < 0.05 ) .


Daily maximum and daily minimum , but not 6 am , glucose levels were significantly different based on treatment group ( p < 0.05 ) .


Insulin significantly increased resting energy expenditure and improved bone mineral content ( p < 0.05 ) .


Each additional wound infection increased incidence of hyperglycemia ( p = 0.004 ) .


There was no mortality in patients not receiving insulin , only in patients who received insulin ( p < 0.004 ) .


Muscle strength was increased in patients receiving insulin ( p < 0.05 ) .


Burn-induced hyperglycemia develops in a subset of severely burned children .


Length of stay was reduced in the no insulin group , and there were no deaths in this group .


Administration of insulin positively impacted bone mineral content and muscle strength , but increased resting energy expenditure , hypoglycemic episodes , and mortality .


New glucose-lowering strategies might be needed .


To determine the pharmacokinetics of doxycycline hyclate administered orally in the form of experimental formulations with different proportions of acrylic acid-polymethacrylate-based matrices .


30 healthy adult dogs .


In a crossover study , dogs were randomly assigned ( in groups of 10 ) to receive a single oral dose ( 20 mg/kg ) of doxycycline hyclate without excipients ( control ) or extended-release formulations ( ERFs ) containing doxycycline , acrylic acid polymer , and polymethacrylate in the following proportions : 1:0.5:0.0075 ( ERF1 ) or 1:1:0.015 ( ERF2 ) .


Serum concentrations of doxycycline were determined for pharmacokinetic analysis before and at several intervals after each treatment .


Following oral administration to the study dogs , each ERF resulted in therapeutic serum doxycycline concentrations for 48 hours , whereas the control treatment resulted in therapeutic serum doxycycline concentrations for only 24 hours .


All pharmacokinetic parameters for ERF1 and ERF2 were significantly different ; however , findings for ERF1 did not differ significantly from those for the control treatment .


Results indicated that both ERFs containing doxycycline , acrylic acid polymer , and polymethacrylate had an adequate pharmacokinetic-pharmacodynamic relationship for a time-dependent drug and a longer release time than doxycycline alone following oral administration in dogs .


Given the minimum effective serum doxycycline concentration of 0.26 g/mL , a dose interval of 48 hours can be achieved for each tested ERF .


This minimum inhibitory concentration has the potential to be effective against several susceptible bacteria involved in important infections in dogs .


Treatment of dogs with either ERF may have several benefits over treatment with doxycycline alone .


This study compared mid-term functional and radiologic results of syndesmotic transfixation with no fixation in supination external rotation ( SER ) ankle fractures with intraoperatively confirmed syndesmosis disruption .


Our hypothesis was that early-stage good functional results would remain and unfixed syndesmosis disruption in SER IV ankle fractures would not lead to an increased incidence of osteoarthritis .


A prospective study of 140 operatively treated patients with Lauge-Hansen SER IV ( Weber B ) ankle fractures was performed .


After bony fixation , the 7.5-Nm standardized external rotation stress test for both ankles was performed under fluoroscopy .


A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs .


The patients were randomized to either syndesmotic screw fixation ( 13 patients ) or no syndesmotic fixation ( 11 patients ) .


After a minimum of 4 years of follow-up ( mean , 58 months ) , ankle function and pain ( Olerud-Molander , a 100-mm visual analogue scale [ VAS ] for ankle function and pain ) and quality of life ( RAND-36 ) of all 24 patients were assessed .


Ankle joint congruity and osteoarthritis were assessed using mortise and lateral projection plain weight-bearing radiographs and magnetic resonance imaging ( MRI ; 3T ) scans .


Improvement in Olerud-Molander score , VAS , and RAND-36 showed no significant difference between groups during the follow-up .


In the syndesmotic transfixation group , improvements in all functional parameters and pain measurements were not significant , whereas in the group without syndesmotic fixation , the Olerud-Molander score improved from 84 to 93 ( P = .007 ) and the pain ( VAS ) score improved from 11 to 4 ( P = .038 ) from 1 year to last follow-up .


X-ray or MRI imaging showed no difference between groups at the last follow-up visit .


With the numbers available , no significant difference in functional outcome or radiologic findings could be detected between syndesmosis transfixation and no-fixation patients with SER IV ankle fracture after a minimum of 4 years of follow-up .


Level II , prospective comparative study .


To observe the impacts on post-stroke spastic hemiplegia treated with temporal three-needle therapy , spastic three-needle therapy , and rehabilitative therapy as well as combined application .


One hundred cases were randomized into a Jin 's three-needle group ( 35 cases ) , a rehabilitation group ( 33 cases ) and a combined therapy group ( 32 cases ) .


Beside the basic treatment , the acupuncture therapy of temporal three-needle and spastic three-needle techniques , rehabilitation training , and the combined therapy of acupuncture and rehabilitation were applied in the Jin 's three-needle group , the rehabilitation group and the combined therapy group , respectively .


Before treatment , in 7 days and 14 days of treatment , the functional comprehensive assessment scale ( FCA ) , clinical neurological defect score ( NDS ) , four-limb simplified Fugl-Meyer assessment ( FMA ) and clinical spasm index ( CSI ) were adopted to assess the spastic degree and limb function , respectively .


In terms of FCA , NDS and FMA , in 7 days of treatment , except the rehabilitation group , the results in the other two groups were all improved as compared with those before treatment ( all P < 0.05 ) .


The results in the Jin 's three-needle group and the combined therapy group were better than those in the rehabilitation group ( all P < 0.05 ) .


In 14 days of treatment , the results in the three groups were improved as compared with those before treatment and in 7 days of treatment ( P < 0.05 , P < 0.01 ) .


The results in the combined therapy group were better than those in the other two groups ( all P < 0.05 ) .


Regarding CSI assessment , in 7 days of treatment , the results of the three groups were all improved significantly as compared with those before treatment ( P < 0.05 , P < 0.01 ) , and the results in the combined therapy group were better than those in the other two groups ( all P < 0.05 ) .


In 14 days of treatment , CSI scores were further improved in the three groups , but the difference was not significant in comparison ( all P > 0.05 ) .


The Jin 's three-needle therapy , rehabilitation therapy and the combined application all relieve the symptoms of post-stroke spastic hemiplegia .


The effect in the Jin 's three-needle group and the combined therapy group is achieved in 7 days of treatment , which is better than that in the rehabilitation group .


The combined therapy a chieves the best effect on spasm in comparison with the single therapy .


The ` Older People 's Exercise intervention in Residential and nursing Accommodation ' ( OPERA ) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly , physiotherapist-led exercise classes on depressive symptoms in care home residents , but found no effect .


We report a process evaluation exploring potential explanations for the lack of effect .


The OPERA trial included over 1,000 residents in 78 care homes in the UK .


We used a mixed methods approach including quantitative data collected from all homes .


In eight case study homes , we carried out repeated periods of observation and interviews with residents , care staff and managers .


At the end of the intervention , we held focus groups with OPERA research staff .


We reported our first findings before the trial outcome was known .


Homes showed large variations in activity at baseline and throughout the trial .


Overall attendance rate at the group exercise sessions was low ( 50 % ) .


We considered two issues that might explain the negative outcome : whether the intervention changed the culture of the homes , and whether the residents engaged with the intervention .


We found low levels of staff training , few home champions for the intervention and a culture that prioritised protecting residents from harm over encouraging activity .


The trial team delivered 3,191 exercise groups but only 36 % of participants attended at least 1 group per week and depressed residents attended significantly fewer groups than those who were not depressed .


Residents were very frail and therefore most groups only included seated exercises .


The intervention did not change the culture of the homes and , in the case study homes , activity levels did not change outside the exercise groups .


Residents did not engage in the exercise groups at a sufficient level , and this was particularly true for those with depressive symptoms at baseline .


The physical and mental frailty of care home residents may make it impossible to deliver a sufficiently intense exercise intervention to impact on depressive symptoms .


To compare the effect of different types and concentrations of sweet solutions on neonatal pain during heel lance procedure .


Totally 560 full term neonates ( male 295 , female 265 ) were randomized into 7 groups : placebo group ( plain water ) , 10 % glucose , 25 % glucose , 50 % glucose , 12 % sucrose , 24 % sucrose and 30 % sucrose groups.In each group , 2 ml corresponding oral solutions were administered through a syringe by dripping into the neonate 's mouth 2 minute before heel lance .


The procedure process was recorded by videos , from which to collect heart rate , oxygen saturation and pain score 1 min before puncture , 3 , 5 and 10 min after puncture .


The average heart rate increase 3 , 5 and 10 min after procedure in the 25 % and 50 % glucose groups , 12 % and 24 % and 30 % sucrose groups was significantly lower than those in the placebo group ( P < 0.01 or 0.05 ) .


The average heart rate increase 3 min after procedure in the sucrose group was lower than that in the glucose group ( P < 0.01 ) .


Neonates who received 30 % sucrose has a significantly lower average heart rate increase than those who received 12 % and 24 % sucrose 3 min after heel lance ( both P < 0.05 ) .


The average oxygen saturation decrease 3 , 5 , 10 min after procedure was significantly lower than those in the placebo group ( P < 0.01 ) .


The average oxygen saturation decrease 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups ( P < 0.01 ) .


The average pain score 3 , 5 , 10 min after procedure was significantly lower than those in the placebo group ( P < 0.01 ) .


The average pain score 3 min after procedure in the sucrose groups was significantly lower than that in the glucose groups ( P < 0.01 ) .


Oral administration of sweet solutions is an effective way to relieve neonatal pain on procedure , and sucrose has a better pain relief action than glucose , moreover , 30 % sucrose provides better effect in control of heart rate increase 3 min after heel lance , but the best concentration of sucrose for pain relief needs further study .


To compare epirubicin , cisplatin , and capecitabine ( ECX ) with fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) as first-line treatments in patients with advanced gastric or esophagogastric junction ( EGJ ) adenocarcinoma .


This open , randomized , phase III study was carried out in 71 centers .


Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment ( ECX arm ) or FOLFIRI ( FOLFIRI arm ) .


Second-line treatment was predefined ( FOLFIRI for the ECX arm and ECX for the FOLFIRI arm ) .


The primary criterion was time-to-treatment failure ( TTF ) of the first-line therapy .


Secondary criteria were progression-free survival ( PFS ) , overall survival ( OS ) , toxicity , and quality of life .


In all , 416 patients were included ( median age , 61.4 years ; 74 % male ) .


After a median follow-up of 31 months , median TTF was significantly longer with FOLFIRI than with ECX ( 5.1 v 4.2 months ; P = .008 ) .


There was no significant difference between the two groups in median PFS ( 5.3 v 5.8 months ; P = .96 ) , median OS ( 9.5 v 9.7 months ; P = .95 ) , or response rate ( 39.2 % v 37.8 % ) .


First-line FOLFIRI was better tolerated ( overall rate of grade 3 to 4 toxicity , 69 % v 84 % ; P < .001 ; hematologic adverse events [ AEs ] , 38 % v 64.5 % ; P < .001 ; nonhematologic AEs : 53 % v 53.5 % ; P = .81 ) .


FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX .


Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents .


To observe the effect of Ginkgo Leaves Tablet ( GLT ) on memory quotient ( MQ ) of mild cognitive impairment ( MCI ) patients .


One hundred and thirteen patients were randomly assigned to the control group ( 55 cases ) and the treatment group ( 58 cases ) .


Patients in the control group received dietetic therapy and physical exercises , while those in the treatment group additionally took GLT , 19.2 mg each time , three times daily .


The treatment course was 12 months for all .


The MQ of all the patients was assessed by WMS-RC before treatment , at 6-month of treatment , and 12-month of treatment .


Compared with the control group , the improvement of MQ increased in the treatment group 0.5 and 1 year after treatment ( P < 0.05 ) .


The clinical efficiency of MQ obviously increased in the treatment group ( 48.28 % and 50.00 % ) , showing statistical difference when compared with the control group ( 30.91 % and 27.27 % , P < 0.05 , P < 0.01 ) .


There was statistical difference in added scores of recognition , regeneration , understanding , and recitation test at 6-month of treatment and 12-month of treatment between the treatment group and the control group ( P < 0.05 , P < 0.01 ) .


GLT was effective in improving MQ of MCI patients , especially in improving recognition , regeneration , understanding , and recitation test .


The current study is the first to examine whether reactivation of fear memory prior to exposure therapy reduces relapse in a randomized clinical sample .


In a standardized treatment protocol combining virtual reality and in-vivo exposure , patients underwent a fear reactivation procedure using a virtual spider 10 min prior to a virtual reality ( VR ) exposure ( reactivation group : RG , n = 15 ) .


A control group ( CG , n = 17 ) was exposed to a virtual plant 10 min prior to the VR exposure .


Outcome measures were a VR spontaneous recovery test ( SRT ) and in-vivo a behavioral avoidance test assessed 24 h after VR exposure .


One week later an in-vivo exposure session followed .


Additionally , a follow-up using psychometric assessment was conducted six months after the first session .


Both groups benefitted significantly and equally from the combined treatment , and importantly , the SRT revealed no return of fear in both groups .


Furthermore , follow-up tests showed long-term treatment effects with no group differences .


Due to different study components ( VR treatment and in-vivo ) , we were not able to determine which treatment module was mainly responsible for the long-term treatment effect .


Furthermore , no direct measure of memory destabilization was possible in this study .


Our treatment package was highly effective in reducing phobic fear up to 6 months following treatment .


Explicit fear reactivation prior to exposure was not beneficial in VR exposure treatment , possibly due to a failure to induce a memory destabilization or due to an implicit fear reactivation prior to treatment in both groups .


Antibiotic prescribing in dentistry accounts for 9 % of total antibiotic prescriptions in Scottish primary care .


The Scottish Dental Clinical Effectiveness Programme ( SDCEP ) published guidance in April 2008 ( 2nd edition , August 2011 ) for Drug Prescribing in Dentistry , which aims to assist dentists to make evidence-based antibiotic prescribing decisions .


However , wide variation in prescribing persists and the overall use of antibiotics is increasing .


RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland .


Its aim is to compare the effectiveness of individualised audit and feedback ( A&F ) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing .


The trial uses routinely collected electronic healthcare data in five aspects of its design in order to : identify the study population ; apply eligibility criteria ; carry out stratified randomisation ; generate the trial intervention ; analyse trial outcomes .


Eligibility was determined on contract status and a minimum level of recent NHS treatment provision .


All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group .


Randomisation was stratified by single-handed/multi-handed practices .


General dental practitioners ( GDPs ) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months .


GDPs could not be blinded to their practice allocation .


Intervention practices were further randomised using a factorial design to receive feedback with or without : a health board comparator ; a supplementary text-based intervention ; additional feedback at nine months .


The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention .


A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs .


RAPiD will provide a robust evaluation of A&F in dentistry in Scotland .


It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial .


Current Controlled Trials ISRCTN49204710 .


To evaluate the efficacy of tramadol , lidocaine , and a combination of tramadol with lidocaine in pain relief using periprostatic nerve block technique by guidance of transrectal ultrasound ( TRUS ) before the prostate biopsy ( PBx ) .


For the indication of TRUS-PBx , the patients with a prostate-specific antigen ( PSA ) level > 4.0 ng/mL or abnormal digital examination findings were selected .


The patients were randomized through random method .


Group 1 : patients were administered 5 mL of 2 % lidocaine ; group 2 : patients were administered 5 mL of 25-mg tramadol ; and group 3 : patients were administered 5 mL of 2 % lidocaine + 25-mg tramadol .


The procedures were completed in 10 minutes , and a visual pain scale was administered to the patients to question the pain severity .


TRUS-guided PBx was performed in 60 patients with an age range of 57-77 years ( mean age , 66.2 7.49 years ) and a PSA range of 1-1000 ng/mL .


The mean PSA level of the groups was 28.5 ( 7.5 ) , 16.1 ( 5.0 ) , and 14.9 ( 2.9 ) ng/mL , respectively .


The postprocedural pain scores by visual pain scale were 4.6 1.2 , 5.4 1.2 , and 3.6 0.9 in lidocaine , tramadol , and lidocaine + tramadol groups , respectively .


Periprostatic nerve block is the current golden standard method owing to pain management and comfort provided , independent of the patient age and the number of core biopsies .


We suggest that tramadol may also be used in this field to achieve better pain management by improving lidocaine 's effect or as an alternative to lidocaine .


While Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness , few studies have examined the relative contribution of different Web-based components to improve outcomes .


Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care .


Our aim was to compare in regular care the effects of ( 1 ) an Internet-based patient provider communication service ( IPPC ) , ( 2 ) WebChoice , a Web-based illness management system for breast cancer patients ( IPPC included ) , and ( 3 ) usual care on symptom distress , anxiety , depression , ( primary outcomes ) , and self-efficacy ( secondary outcome ) .


This study reports preliminary findings from 6 months ' follow-up data in a 12-month trial .


We recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals .


The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated .


In addition to the IPPC , WebChoice contains components for symptom monitoring , tailored information and self-management support , a diary , and communication with other patients .


A total of 20 care providers ( 11 nurses , 6 physicians , and 3 social workers ) were trained to answer questions from patients .


Outcomes were measured with questionnaires at study entry and at study months 2 , 4 , and 6 .


Linear mixed models for repeated measures were fitted to compare effects on outcomes over time .


Patients were randomly assigned to the WebChoice group ( n = 64 ) , the IPPC group ( n = 45 ) , or the usual care group ( n = 58 ) .


Response rates to questionnaires were 73.7 % ( 123/167 ) at 2 months , 65.9 ( 110/167 ) at 4 months , and 62.3 % ( 104/167 ) at 6 months .


Attrition was similar in all study groups .


Among those with access to WebChoice , 64 % ( 41/64 ) logged on more than once and 39 % ( 25/64 ) sent e-messages to care providers .


In the IPPC group , 40 % ( 18/45 ) sent e-messages .


Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress ( mean difference 0.16 , 95 % CI 0.06-0 .25 , P = .001 ) , anxiety ( mean difference 0.79 , 95 % CI 0.09-1 .49 , P = .03 ) , and depression ( mean difference 0.79 , 95 % CI 0.09-1 .49 , P = .03 ) compared with the usual care group .


The IPPC group reported significant lower depression scores compared with the usual care group ( mean difference 0.69 , 95 % CI 0.05-1 .32 , P = .03 ) , but no differences were observed for symptom distress or anxiety .


No significant differences in self-efficacy were found among the study groups .


In spite of practice variations and moderate use of the interventions , our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness .


Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising .


However , the multicomponent intervention WebChoice had additional positive effects .


Clinicaltrials.gov : NCT00971009 ; http://clinicaltrials.gov/show/NCT00971009 ( Archived by WebCite at http://www.webcitation.org/6USKezP0Y ) .


The aim of the study was to assess the impact of LYM-X-SORB ( LXS ) , an organized lipid matrix that has been shown to be absorbable without pancreatic enzyme therapy on fat-soluble vitamin status in children with cystic fibrosis ( CF ) and pancreatic insufficiency ( PI ) .


Children with CF and PI were randomized to daily LXS or an isocaloric placebo comparison supplement for 12 months .


Serum vitamins A ( retinol ) , D ( 25-hydroxyvitamin D [ 25D ] ) , E ( - tocopherol , - tocopherol : cholesterol ratio ) , and K ( percentage of undercarboxylated osteocalcin [ % ucOC ] and plasma proteins induced by vitamin K absence factor II [ PIVKA II ] ) were assessed at baseline and 12 months .


Dietary intake was determined using 3-day weighed food records and supplemental vitamin intake by a comprehensive questionnaire .


A total of 58 subjects ( 32 boys , age 10.3 2.9 years [ mean standard deviation ] ) with complete serum vitamin , dietary and supplemental vitamin data were analyzed .


After adjusting for dietary and supplemental vitamin intake , serum retinol increased 3.0 1.4 g/dL ( coefficient standard error ) ( adjusted R2 = 0.02 , P = 0.03 ) and vitamin K status improved as demonstrated by a decreased percentage of undercarboxylated osteocalcin of -6.0 % 1.6 % by 12 months ( adjusted R2 = 0.15 , P < 0.001 ) .


These changes occurred in both the LXS and placebo comparison groups .


No changes in serum 25D or - tocopherol were detected .


Both nutrition interventions increased caloric intake a mean of 83 666 kcal/day by 12 months .


Vitamins A and K status improved , whereas vitamins D and E status was unchanged during 12 months of LXS and isocaloric placebo comparison supplement in children with CF and PI .


The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people , including individuals with cognitive impairment or comorbidities .


A randomized , single-blind , parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat ( Barcelona ) .


Of 696 referred people who were born in 1924 , 328 were randomized to an intervention group or a control group .


The intervention model used an algorithm and was multifaceted for both patients and their primary care providers .


Primary outcomes were risk of falling and time until falls .


Data analyses were by intention-to-treat .


Sixty-five ( 39.6 % ) subjects in the intervention group and 48 ( 29.3 % ) in the control group fell during follow-up .


The difference in the risk of falls was not significant ( relative risk 1.28 , 95 % confidence interval [ CI ] 0.94-1 .75 ) .


Cox regression models with time from randomization to the first fall were not significant .


Cox models for recurrent falls showed that intervention had a negative effect ( hazard ratio [ HR ] 1.46 , 95 % CI 1.03-2 .09 ) and that functional impairment ( HR 1.42 , 95 % CI 0.97-2 .12 ) , previous falls ( HR 1.09 , 95 % CI 0.74-1 .60 ) , and cognitive impairment ( HR 1.08 , 95 % CI 0.72-1 .60 ) had no effect on the assessment .


This multifactorial intervention among octogenarians , including individuals with cognitive impairment or comorbidities , did not result in a reduction in falls .


A history of previous falls , disability , and cognitive impairment had no effect on the program among the community-dwelling subjects in this study .


There is a need to identify novel pharmacologic targets to treat alcoholism .


Animal and human studies suggest a role for ghrelin in the neurobiology of alcohol dependence and craving .


Here , we were the first to test the hypothesis that intravenous administration of exogenous ghrelin acutely increases alcohol craving .


This was a double-blind , placebo-controlled human laboratory proof-of-concept study .


Nontreatment-seeking , alcohol-dependent , heavy-drinking individuals were randomized to receive intravenous ghrelin 1 mcg/kg , 3 mcg/kg or 0 mcg/kg ( placebo ) , followed by a cue-reactivity procedure , during which participants were exposed to neutral ( juice ) and alcohol cues .


The primary outcome variable was the increase in alcohol craving ( also called urge ) for alcohol , assessed by the Alcohol Visual Analogue Scale .


Out of 103 screenings , 45 individuals received the study drug .


Repeated measures of analysis of covariance revealed a group effect across ghrelin doses in increasing alcohol craving ( p < .05 ) .


A dose-specific examination revealed a significant effect of ghrelin 3 mcg/kg versus placebo in increasing alcohol craving ( p < .05 ) with a large effect size ( d = .94 ) .


By contrast , no significant ghrelin effect was found in increasing either urge to drink juice or food craving ( p = ns ) .


No significant differences in side effects were found ( p = ns ) .


Intravenous administration of exogenous ghrelin increased alcohol craving in alcohol-dependent heavy-drinking individuals .


Although the small sample requires confirmatory studies , these findings provide preliminary evidence that ghrelin may play a role in the neurobiology of alcohol craving , thus demonstrating a novel pharmacologic target for treatment .


Various treatments are available for reducible unstable fractures of the distal radius , such as closed reduction combined with fixation by external fixator ( EF ) , and rigid internal fixation using a locked volar plate ( VP ) .


Although there are studies comparing these methods , there is no conclusive evidence indicating which treatment is best .


The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome ( patient-reported ) .


The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP .


Patients will be randomly assigned ( assignment ratio 1:1 ) using sealed opaque envelopes .


This trial will include consecutive adult patients with an acute ( up to 15 days ) displaced , unstable fracture of the distal end of the radius of type A2 , A3 , C1 , C2 or C3 by the Arbeitsgemeinschaft fr Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification , without previous surgical treatments of the wrist .


The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described .


Evaluations will be performed at 2 , and 8 weeks , 3 , 6 and 12 months , with the primary outcomes being measured by the Disabilities of the Arm , Shoulder and Hand ( DASH ) questionnaire and measurement of pain ( Visual Analog Pain Scale and digital algometer ) .


Secondary outcomes will include radiographic parameters , objective functional evaluation ( goniometry and dynamometry ) , and the rate of complications and method failure according to the intention-to-treat principle .


Final postoperative evaluations ( 6 and 12 months ) will be performed by independent blinded evaluators .


For the Student 's t-test , a difference of 10 points in the DASH score , with a 95 % confidence interval , a statistical power of 80 % , and 20 % sampling error results in 36 patients per group .


Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures .


ISCRTN09599740 .


Excess sodium intake is associated with high blood pressure , a major risk factor for cardiovascular disease ( CVD ) .


It is unknown whether decreasing sodium intake to < 2300 mg/d has an effect on CVD or all-cause mortality .


The objective was to assess whether reductions in sodium intake to < 2300 mg/d were associated with either an increased or a decreased risk of fatal and nonfatal CVD and all-cause mortality .


This observational prospective study of the PREvencin con DIeta MEDiterrnea ( PREDIMED ) trial included 3982 participants at high CVD risk .


Sodium intake was evaluated with a validated food-frequency questionnaire and categorized as low ( < 1500 mg/d ) , intermediate ( 1500 to 2300 mg/d ) , high ( > 2300 to 3400 mg/d ) , or very high ( > 3400 mg/d ) .


Subsequently , 1-y and 3-y changes in sodium intake were calculated .


Multivariate relative risks were assessed by using Cox proportional hazards ratios .


Marginal structural models with inverse probability weighting were used to test the effect of changes in sodium intake and the Mediterranean diet ( MedDiet ) .


We documented 125 CVD events and 131 deaths after a 4.8-y median follow-up .


Sodium intake < 2300 mg/d was associated with a lower risk of all-cause mortality : 48 % ( HR : 0.52 ; 95 % CI : 0.30 , 0.91 ; P = 0.02 ) and 49 % ( HR : 0.51 ; 95 % CI : 0.26 , 0.98 ; P = 0.04 ) after 1 and 3 y , respectively .


Increasing sodium intake after 1 y was associated with a 72 % ( HR : 1.72 ; 95 % CI : 1.01 , 2.91 ; P = 0.04 ) higher risk of CVD events .


The incidence rate of CVD was reduced for those who reduced their sodium intake and were randomly assigned to MedDiet interventions [ 4.1 / 10,000 ( 95 % CI : 3.1 , 8.0 ) compared with 4.4 / 10,000 ( 95 % CI : 2.7 , 12.4 ) person-years ; P = 0.002 ] .


Decreasing sodium intake to < 2300 mg/d was associated with a reduced risk of all-cause mortality , whereas increasing the intake to > 2300 mg/d was associated with a higher risk of CVD .


Our observational data suggest that sodium intake < 2300 mg/d was associated with an enhanced beneficial effect of the MedDiet on CVD .


These results should be interpreted with caution , and other confirmatory studies are necessary .


In patients with ST-segment elevation myocardial infarction ( STEMI ) who undergo primary percutaneous coronary intervention ( pPCI ) , the use of dual antiplatelet therapy is essential to prevent atherothrombotic complications .


Therefore , patients are treated with acetylsalicylic acid and clopidogrel , prasugrel , or ticagrelor .


Clopidogrel , however , shows a major interindividual variation in antiplatelet effect , which is correlated to an increase in atherothrombotic events in patients with high platelet reactivity .


This interindividual variation is partly a result of CYP2C19 genetic variants .


Ticagrelor and prasugrel reduce atherothrombotic events but increase bleeding rate and drug costs , as compared with clopidogrel .


CYP2C19-based tailoring of antiplatelet therapy might be beneficial to STEMI patients .


POPular Genetics ( NCT01761786 ) is a randomized , open-label , multicenter trial involving 2,700 STEMI patients who undergo pPCI .


Patients are randomized to CYP2C19 genotyping or routine ticagrelor or prasugrel treatment .


In the genotyping group , * 1 / * 1 ( wild-type ) patients receive clopidogrel , and patients carrying 1 or 2 * 2 or * 3 loss-of-function alleles receive ticagrelor or prasugrel .


The primary net clinical benefit end point is the composite of death , ( recurrent ) myocardial infarction , definite stent thrombosis , stroke , and Platelet Inhibition and Patient Outcomes ( PLATO ) major bleeding at 1 year .


Primary safety end point is the composite of ( PLATO ) major and minor bleeding .


Cost-effectiveness and quality of life will be assessed by calculating quality-adjusted life-years , net costs per life-year , and per quality-adjusted life-year gained .


The POPular Genetics study is the first large-scale trial comparing CYP2C19 genotype-guided antiplatelet therapy to a nontailored strategy in terms of net clinical benefit , safety , and cost-effectiveness .


Head and neck cancer ( HNC ) patients are prone to have a poor health-related quality of life after cancer treatment .


This study investigated the effect of the nurse counselling and after intervention ( NUCAI ) on the health-related quality of life and depressive symptoms of HNC patients between 12 and 24 months after cancer treatment .


Two hundred and five HNC patients were randomly allocated to NUCAI ( N = 103 ) or usual care ( N = 102 ) .


The 12-month nurse-led NUCAI is problem-focused and patient-driven and aims to help HNC patients manage with the physical , psychological and social consequences of their disease and its treatment .


Health-related quality of life was evaluated with the EORTC QLQ-C30 and QLQ H&N 35 .


Depressive symptoms were evaluated with the CES-D .


At 12 months the intervention group showed a significant ( P < 0.05 ) improvement in emotional and physical functioning , pain , swallowing , social contact , mouth opening and depressive symptoms .


At 18 months , global quality of life , role and emotional functioning , pain , swallowing , mouth opening and depressive symptoms were significantly better in the intervention group than in the control group , and at 24 months emotional functioning and fatigue were significantly better in the intervention group .


The NUCAI effectively improved several domains of health-related quality of life and depressive symptoms in HNC patients and would seem a promising intervention for implementation in daily clinical practice .


To compare the efficacy and safety of the levonorgestrel-releasing intrauterine device ( LNG-IUD ) with dydrogesterone applied for the same duration in patients having endometrial hyperplasia ( EH ) without atypia .


One hundred thirty eight women aged between 30 and 50 years with abnormal uterine bleeding and diagnosed as EH by transvaginal ultrasound were randomized to receive either LNG-IUD or dydrogesterone for 6 months .


Primary outcome measures were regression of hyperplasia after 6 months of therapy .


Secondary outcome measures were occurrence of side effects during treatment or recurrence of hyperplasia during follow-up period .


After 6 months of treatment , regression of EH occurs in 96 % of women in the levonorgestrel-releasing intrauterine system ( LNG-IUS ) group versus 80 % of women in the oral group ( P < .001 ) .


Adverse effects were relatively common with minimal differences between the 2 groups .


Intermenstrual vaginal spotting and amenorrhea were more common in the LNG-IUD group ( P value .01 and .0001 ) .


Patient satisfaction was significantly higher in the LNG-IUS group ( P value .0001 ) .


Hysterectomy rates were lower in the LNG-IUS group than in the oral group ( P = .001 ) .


Recurrence rate was 0 % in the LNG-IUD group compared to 12.5 % in the oral group .


In management of EH without atypia , LNG-IUS achieves a higher regression and a lower hysterectomy rate than oral progesterone and could be used as a first-line therapy .


To observe the effect of Sancaijiangtang powders on plasma nitric oxide and endothelin-1 levels .


We sought to identify the common pathological link and mechanism of action for Traditional Chinese medicine in type 2 diabetes mellitus and vascular dementia , and to explicate the material basis for treating the different diseases with the same method in Traditional Chinese Medicine .


In total , 168 patients with type 2 diabetes mellitus and vascular dementia were enrolled in the study , and randomly divided into two groups by simple randomization .


Patients in the treatment group received oral Sancaijiangtang powders with pioglitazone hydrochloride three times daily , while patients in the control group received pioglitazone hydrochloride alone .


The treatment course was for 12 weeks .


Mini-mental state examinations ( Chinese version ) and Montreal Cognitive Assessments ( Beijing version ) were performed , and fasting plasma glucose , fasting insulin , hemoglobin A1c , homeostasis model assessment of insulin resistance , plasma nitric oxide and endothelin-1 levels were measured before and after the treatment .


The post-treatment levels for all measurements in both groups were better than pre-treat - ment levels ( P < 0.05 ) .


The post-treatment levels for all measurements in the treatment group were better than the levels measured in the control group ( P < 0.05 ) .


Type 2 diabetes mellitus and vascular dementia have common pathological mechanisms for insulin resistance and endothelium dysfunction .


Sancaijiangtang powders could improve the release of nitric oxide and inhibit the secretion of endothelin-1 .


Therefore , the material basis exists for treating the different diseases with the same method in Traditional Chinese Medicine .


The objectives of this prospective study were to compare the advantages of single-port laparoscopic cholecystectomy ( SPLC ) versus the classical four-port laparoscopic cholecystectomy ( CLC ) and to discuss these advantages in the light of current literature .


Forty eligible patients were randomized to receive SPLC ( Group A , N. = 20 ) and CLC ( Group B , N. = 20 ) , and investigated with regard to age , sex , BMI ( body mass index ) , ASA ( American Society of Anesthesiologists ) score , type of surgery , operative time , per-operative complication , indication for conversion to open surgery , indication for additional trocar placement in SPLC technique , post-operative pain score , additional narcotic analgesic requirement , nausea and vomiting , post-operative complication and length of hospital stay .


Visual analogue scale ( VAS ) was used for pain scoring in all cases .


No significant difference was found among patients in Group A and Group B in terms of age , sex , weight/BMI , ASA score , VAS scores , additional analgesic requirement and length of hospital stay ( P > 0.05 ) .


On the other hand , mean operative time in Group A was significantly ( P < 0.005 ) greater than that in Group B. Mean operative time in Group A was observed to be reduced after the first 10 operations .


Conversion to open surgery was not required in any of the patients ; however , additional trocar placement was required in two patients in Group A due to body habitus and adhesions , and operations were completed laparoscopically .


We conclude that SPLC is equally effective as CLC .


Patient comfort is increased and pain is decreased as the surgeon gets experienced with the technique .


The pediatric diffuse intrinsic pontine glioma ( DIPG ) outcome remains dismal despite multiple therapeutic attempts .


To compare the results of treatment of pediatric diffuse intrinsic pontine glioma ( DIPG ) using hypofractionated versus conventional radiotherapy .


Seventy-one newly diagnosed DIPG children were randomized into hypofractionated ( HF ) ( 39Gy/13 fractions in 2.6 weeks ) and conventional ( CF ) arm ( 54Gy/30 fractions in 6weeks ) .


The median and one-year overall survival ( OS ) was 7.8 months and 36.48.2 % for the hypofractionated arm , and 9.5 and 26.27.4 % for the conventional arm respectively .


The 18-month OS difference was 2.2 % .


The OS hazard ratio ( HR ) was 1.14 ( 95 % CI : 0.70-1 .89 ) ( p = 0.59 ) .


The hypofractionated arm had a median and one-year progression-free survival ( PFS ) of 6.6 months and 22.57.1 % , compared to 7.3 and 17.97.1 % for the conventional arm .


The PFS HR was 1.10 ( 95 % CI : 0.67-1 .90 ) ( p = 0.71 ) .


The 18-month PFS difference was 1.1 % .


These differences exceed the non-inferiority margin .


The immediate and delayed side effects were not different in the 2 arms .


Hypofractionated radiotherapy offers lesser burden on the patients , their families and the treating departments , with nearly comparable results to conventional fractionation , though not fulfilling the non-inferiority assumption .


Pregnancy rates in US contraceptive clinical trials are increasing due to decreased treatment compliance .


This study compared compliance with a new low-dose levonorgestrel ( LNG ) and ethinyl estradiol ( EE ) contraceptive patch ( CP , Twirla ) with that of a low-dose combination oral contraceptive ( COC ) in a demographically diverse population .


This analysis was part of an open-label , parallel-group , multicenter phase 3 study that randomized healthy sexually active women ( 17-40years ) to 13cycles of LNG/EE CP or 6cycles of COC , then 7cycles of LNG/EE CP .


We defined self-reported compliance as cycles that , according to diaries , show 21days of patch wear without missed days or any patch worn > 7days or 21days of pill-taking without missed pill days .


We verified compliance by detectable plasma presence of LNG and EE at cycles 2 , 6 , and 13 .


Of the intention-to-treat population with diary information ( N = 1328 , mean age 26.4 years , 46 % minorities , 33 % obese ) , 10.0 % of the CP ( n = 998 ) versus 21.2 % of the COC group ( n = 330 ) self-reported noncompliance after 6cycles ( p < .001 ) .


Laboratory assessments verified 10-14 % of participants in both groups as noncompliant .


Self-reported perfect use did not vary between obese [ body mass index ( BMI ) 30kg/m ( 2 ) ] versus nonobese ( BMI < 30kg/m ( 2 ) ) participants in both groups or when stratified by age , education , or race/ethnicity in the CP group .


Self-reported compliance was significantly greater in the CP than COC group and did not vary by obesity status .


Discrepancies between self-reported and verified compliance question reliability of patient diaries .


This paper , based on an analysis of a phase 3 trial , shows that compliance was significantly greater with a new weekly transdermal CP than with a once-daily COC in obese as well as nonobese participants .


Discrepancies between self-reported compliance and laboratory-verified compliance raise questions regarding the reliability of patient diaries .


Pediatric respiratory infections caused by antibiotic-nonsusceptible Streptococcus pneumoniae ( ANSP ) continue to present an important challenge , even after introduction of 7-valent pneumococcal conjugate vaccine ( PCV7 ) .


This randomized double-blind trial assessed the potential additional impact of PCV13 over PCV7 on reducing ANSP carriage .


Healthy infants were randomly assigned to receive PCV13 ( n = 932 ) or PCV7 ( n = 934 ) at ages 2 , 4 , 6 , or 12 months .


Eight nasopharyngeal specimens were collected by swabbing between ages 2 and 24 months .


S. pneumoniae isolates were serotyped and tested for antimicrobial susceptibility by the disk-diffusion method and the Etest .


Nasopharyngeal acquisition and prevalence of ANSP during ages 7-24 months were compared between the 2 vaccine groups .


In general , new acquisition of pneumococci nonsusceptible to penicillin , erythromycin , clindamycin , penicillin plus erythromycin , and multiple drugs ( 3 antibiotics ) was significantly lower in the PCV13 group compared with the PCV7 group ; the main serotypes contributing to this significant decrease were serotype 19F , present in PCV13 and PCV7 , and serotypes 6A and 19A , present in PCV13 only .


PCV13 has a significant added benefit over PCV7 in reducing carriage of ANSP .


Because carriage determines transmission , these results suggest that PCV13 will provide protection against ANSP disease that exceeds protection provided by PCV7 .


NCT00508742 .


Homeless adults are more likely to smoke tobacco and are less likely to successfully quit smoking than smokers in the general population , despite comparable numbers of cessation attempts and desire to quit .


To date , studies that have examined smoking cessation in homeless samples have used traditional lab/clinic-based assessment methodologies .


Real-time assessment of key variables may provide new insights into the process of quitting among homeless smokers .


The purpose of the current study was to identify predictors of a quit attempt using real-time assessment methodology during the 6 days prior to a scheduled quit attempt among homeless adults seeking care at a shelter-based smoking cessation clinic .


Parameters for multiple variables ( i.e. , motivation for quitting , smoking expectancies , quit self-efficacy , smoking urges , negative affect , positive affect , restlessness , hostility , and stress ) were calculated and were used as predictors of biochemically verified quit date abstinence ( i.e. , 13hr abstinent ) using logistic regression analyses .


Participants ( n = 57 ) were predominantly male ( 59.6 % ) , non-White ( 68.4 % ) , and smoked an average of 18 cigarettes per day .


A total of 1,132 ecological momentary assessments ( 83 % completion rate ) were collected at random times ( i.e. , up to 4 assessments/day ) during the 6 days prior to a scheduled quit attempt .


Results indicated that declining ( negative slope ) negative affect , restlessness , and stress predicted quit date abstinence .


Additionally , increasing positive coping expectancies across the prequit week predicted quit date abstinence .


Study findings highlight multiple variables that may be targeted during the precessation period to increase smoking cessation attempts in this difficult to treat population of smokers .


The goal of this research was to evaluate nutrition education targeting Latinas , a group at particular risk of obesity and diabetes , which predict to later life cardiovascular disease and dementia .


Culturally tailored , theory-based nutrition education was provided to Mexican origin Latinas aged 48 to 84 .


The randomized design compared participants in workshops incorporating the connection between dietary fat and brain health , participants in workshops focusing only on dietary fat and heart health , a waitlist control group , and a posttest only control group .


Among those assigned to either intervention , there was statistically significant gain in health literacy , knowledge about dietary fat , and behaviors to reduce dietary fat compared with waitlist control .


There was no difference in outcomes between those given the module about diet and brain health and those not provided that module .


A program to encourage dietary fat modification in Latinas proved feasible and modestly effective .


Umbilical cord milking ( UCM ) improves blood pressure and urine output , and decreases the need for transfusions in comparison to immediate cord clamping ( ICC ) .


The immediate effect of UCM in the first few minutes of life and the impact on neonatal resuscitation has not been described .


Women admitted to a tertiary care center and delivering before 32 weeks gestation were randomized to receive UCM or ICC .


A blinded analysis of physiologic data collected on the newborns in the delivery room was performed using a data acquisition system .


Heart rate ( HR ) , SpO2 , mean airway pressure ( MAP ) , and FiO2 in the delivery room were compared between infants receiving UCM and infants with ICC .


41 of 60 neonates who were enrolled and randomized had data from analog tracings at birth .


20 of these infants received UCM and 21 had ICC .


Infants receiving UCM had higher heart rates and higher SpO2 over the first 5 minutes of life , were exposed to less FiO2 over the first 10 minutes of life than infants with ICC .


UCM when compared to ICC had decreased need for support immediately following delivery , and in situations where resuscitation interventions were needed immediately , UCM has the advantage of being completed in a very short time to improve stability following delivery .


ClinicalTrials.gov NCT01434732 .


Dialectical Behavior Therapy has been initially designed and evaluated as an outpatient-treatment program for chronic suicidal female patients .


Within the last years , several adaptations of DBT for specific comorbidities , other settings or other disorders related to emotion dysregulation have been developed .


This report reviews conceptual aspects and the scientific evidence of initially designed Dialectical Behavior Therapy and the adaptations .


Systematic literature search and systematic review .


Recently , two meta-analyses which are based on randomized controlled trials conclude robust and stabile effects of DBT Evidence from further RCTs and other studies show promise for the properties of many DBT adaptations .


The current review of the literature suggests a good effectiveness of DBT , especially on complex disorders with deficits in the field of emotion regulation .


Breast cancer ( BC ) is the most common cancer among females in Turkey .


Predictors affecting the breast self-examination ( BSE ) performance vary in developing countries .


To determine the frequency of BSE performance and predictors of self-reported BSEs among women in the capital city of Turkey .


This cross-sectional study was conducted on 376 Turkish women using a self - administered questionnaire covering socio-demographic variables and BSE-related features .


Of the participants , 78.7 % ( N = 296 ) reported practicing BSE , whereas 9.5 % ( N = 28 ) were implementing BSE regularly on a monthly basis , and only 5.7 % ( N = 17 ) were performing BSE regularly within a week after each menstrual cycle .


Multivariate logistic regression modeling revealed that BSE performance was more likely in younger age groups [ 20-39 years ] ( p = 0.018 , OR = 3.215 ) and [ 40-49 years ] ( p = 0.009 , OR = 3.162 ) , women having a family history of breast disease ( p = 0.038 , OR = 2.028 ) , and housewives ( p = 0.013 , OR = 0.353 ) .


Although it appears that the rates of BSE performers are high , the number of women conducting appropriate BSE on a regular time interval basis is lower than expected .


Younger age groups , family history of breast diseases and not being employed were identified as significant predictors of practicing BSE appropriately .


Older age and employment were risk factors for not performing BSE in this sample .


To analyze the results of the use of intra-articular cultured autologous bone marrow-derived mesenchymal stem cell ( MSC ) injections in conjunction with microfracture and medial opening-wedge high tibial osteotomy ( HTO ) .


Fifty-six knees in 56 patients with unicompartmental osteoarthritic knees and genu varum were randomly allocated to the cell-recipient group ( n = 28 ) or control group ( n = 28 ) .


Patients who had a joint line congruity angle of more than 2 , malalignment of the knee from femoral causes , a fixed flexion deformity , or age older than 55 years were excluded .


All patients underwent HTO and microfracture .


The cell-recipient group received intra-articular injection of cultured MSCs with hyaluronic acid 3 weeks after surgery , whereas the control group only received hyaluronic acid .


The primary outcome measure was the International Knee Documentation Committee ( IKDC ) score at intervals of 6 months , 1 year , and 2 years postoperatively .


Secondary outcome measures were Tegner and Lysholm clinical scores and 1-year postoperative Magnetic Resonance Observation of Cartilage Repair Tissue ( MOCART ) scores .


The median age of the patients was 51 years , with a mean body mass index of 23.85 .


Both treatment arms achieved improvements in Tegner , Lysholm , and IKDC scores .


After adjustment for age , baseline scores , and time of evaluation , the cell-recipient group showed significantly better scores .


The effect of treatment showed an added improvement of 7.65 ( 95 % confidence interval [ CI ] , 3.04 to 12.26 ; P = .001 ) for IKDC scores , 7.61 ( 95 % CI , 1.44 to 13.79 ; P = .016 ) for Lysholm scores , and 0.64 ( 95 % CI , 0.10 to 1.19 ; P = .021 ) for Tegner scores .


Magnetic resonance imaging scans performed 1 year after surgical intervention showed significantly better MOCART scores for the cell-recipient group .


The age-adjusted mean difference in MOCART score was 19.6 ( 95 % CI , 10.5 to 28.6 ; P < .001 ) .


Intra-articular injection of cultured MSCs is effective in improving both short-term clinical and MOCART outcomes in patients undergoing HTO and microfracture for varus knees with cartilage defects .


Level II , randomized controlled trial .


This prospective study showed that the incidence of acute anterior uveitis , confirmed by ophthalmic examination , in patients receiving intravenous zoledronate infusions as part of a randomized controlled trial for fracture prevention is 1.1 % .


We prospectively investigated the incidence of ocular side effects after a single intravenous zoledronate infusion .


In a secondary analysis of a double-blind , placebo-controlled trial in which early post-menopausal women ( N = 1054 ) with normal bone density or osteopenia were randomized to infusion of zoledronate 5 mg ( N = 703 ) or placebo ( N = 351 ) , we analyzed significant adverse ocular events occurring within 3 months .


Fourteen participants reported ocular symptoms after the infusion .


All were examined by an ophthalmologist and eight were diagnosed with acute anterior uveitis ( AAU ) and one with sectoral episcleritis .


The incidence of AAU and episcleritis was 1.1 % ( 95 % CI 0.5-2 .1 ) and 0.1 % ( 95 % CI 0.0-0 .7 ) , respectively , in the zoledronate group and 0 % for both conditions in the placebo group ( 95 % CI 0.0-0 .8 ) .


The mean time from infusion to symptom onset for AAU was 3 days ( range 2-4 ) .


Three cases were bilateral .


AAU was mild-moderate in seven participants and severe in one .


All affected eyes were treated with topical cyclopentolate 1 % ( to break , or minimize , posterior synechiae ) , and intensive , potent , topical corticosteroids with a tapering regime based on treatment response .


The mean duration of topical corticosteroid was 2610 days ( range 17-44 ) .


The mean , best corrected visual acuity was 20/20 ( range 20/20-20 / 40 ) at presentation , which remained unchanged after AAU resolution .


None of the participants lost vision , and no long-term sequelae were reported at last follow-up ( range 3-13 months post-infusion ) .


Prescribers should inform patients about the possibility of ocular side effects with zoledronate infusions and refer promptly to an ophthalmologist if symptoms develop .


To evaluate the outcomes of standard automated perimetry ( SAP ) in patients with obstructive sleep apnea ( OSA ) .


Eighty OSA patients and 111 age-matched controls were consecutively and prospectively enrolled .


One eye per subject was randomly selected .


All participants underwent at least one reliable SAP ( 24-2 SITA Standard algorithm ) .


The peripapillary retinal nerve fiber layer thickness ( RNFL ) was measured with spectral-domain optical coherence tomography ( OCT ) .


Patients with OSA were classified into three groups according to the apnea/hypopnea index : mild , moderate , or severe OSA .


Parameters of SAP and OCT were compared between healthy controls and OSA patients .


Correlation of apnea/hypopnea index with OCT and SAP measurements were calculated .


Mean age , best-corrected visual acuity , and central corneal thickness were similar between groups .


Intraocular pressure , however , was lower in the OSA group .


Mean deviation of SAP was -0.23 0.8 dB in the control group and -1.74 2.8 dB in the OSA group ( P < 0.001 ) .


Thickness of RNFL measured with OCT did not differ significantly between groups .


Patients with OSA showed reduced sensitivity at most points tested by white-on-white perimetry compared with healthy individuals .


The threshold values were more depressed in the peripheral visual field .


The apnea/hypopnea index was related to the SAP indices : Pearson correlations were -0.432 with mean deviation , 0.467 with pattern standard deviation , and -0.416 with the visual field index ( P < 0.001 ) .


Patients with OSA exhibited reduced retinal sensitivity measured with SAP compared with healthy controls .


A fluoropyrimidine plus irinotecan or oxaliplatin , combined with bevacizumab ( a monoclonal antibody against vascular endothelial growth factor ) , is standard first-line treatment for metastatic colorectal cancer .


Before the introduction of bevacizumab , chemotherapy with fluorouracil , leucovorin , oxaliplatin , and irinotecan ( FOLFOXIRI ) showed superior efficacy as compared with fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) .


In a phase 2 study , FOLFOXIRI plus bevacizumab showed promising activity and an acceptable rate of adverse effects .


We randomly assigned 508 patients with untreated metastatic colorectal cancer to receive either FOLFIRI plus bevacizumab ( control group ) or FOLFOXIRI plus bevacizumab ( experimental group ) .


Up to 12 cycles of treatment were administered , followed by fluorouracil plus bevacizumab until disease progression .


The primary end point was progression-free survival .


The median progression-free survival was 12.1 months in the experimental group , as compared with 9.7 months in the control group ( hazard ratio for progression , 0.75 ; 95 % confidence interval [ CI ] , 0.62 to 0.90 ; P = 0.003 ) .


The objective response rate was 65 % in the experimental group and 53 % in the control group ( P = 0.006 ) .


Overall survival was longer , but not significantly so , in the experimental group ( 31.0 vs. 25.8 months ; hazard ratio for death , 0.79 ; 95 % CI , 0.63 to 1.00 ; P = 0.054 ) .


The incidences of grade 3 or 4 neurotoxicity , stomatitis , diarrhea , and neutropenia were significantly higher in the experimental group .


FOLFOXIRI plus bevacizumab , as compared with FOLFIRI plus bevacizumab , improved the outcome in patients with metastatic colorectal cancer and increased the incidence of some adverse events .


( Funded by the Gruppo Oncologico Nord Ovest and others ; ClinicalTrials.gov number , NCT00719797 . )


To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol .


In a randomized , controlled , multicenter trial , 900 patients more than 70 years of age received either on-pump or off-pump coronary artery bypass surgery .


Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups .


After the procedure , protamine sulfate was given to revert the activated clotting time to less than 120 seconds .


Coronary angiography was performed 6 months after the operation and graft patency was assessed by independent blinded observers .


A total of 481 patients underwent angiography .


In the off-pump group , 561 ( 79 % ) of 710 grafts were open , 65 ( 9 % ) were stenotic , and 84 ( 12 % ) were occluded .


In the on-pump group , 549 ( 86 % ) of 650 grafts were open , 38 ( 5 % ) were stenotic , and 63 ( 9 % ) were occluded .


The difference between the proportion of open grafts was statistically significant in favor of on-pump surgery ( P = .01 ) .


The proportion of open left internal thoracic artery grafts was 95 % in both groups .


Perioperative use of intracoronary shunts did not increase the risk of stenosis of the coronary artery distal to the anastomosis .


Despite comparable heparinization , graft patency after off-pump surgery was inferior to that after on-pump surgery .


The recommended intake of clear liquids until 2 hours before surgery is reportedly safe and effective .


We investigated whether oral rehydration therapy before surgery had improved satisfaction , stress response , and hemodynamics in patients during perioperative period .


Patients scheduled to undergo laparoscopic colectomy were enrolled and randomly divided into 2 groups .


The oral rehydration therapy ( ORT ) group ( 29 cases ) was allowed to drink clear liquids until 2 hours before anesthesia induction and the control group ( 29 cases ) fasted from 21 : 00 the night before surgery .


All patients entered the operating room at 8 : 40 .


Patient satisfaction was examined after admission to the operating room .


The volume and pH of gastric fluid were measured after anesthetic induction .


The serum concentrations of cortisol and catecholamine were measured as stress response indicators after anesthetic induction and at the completion of surgery .


Intraoperative hemodynamics was also recorded .


There were no differences in patient satisfaction , stress response , and hemodynamics between the 2 groups .


Intraoperative urine volume was significantly larger in the ORT group .


Vomiting and aspiration were not observed in any patient


Oral rehydration therapy until 2 hours before surgery seemed safe but did not improve satisfaction , stress response , and hemodynamics in perioperative patients .


Residual proteinuria during renin-angiotensin-aldosterone system ( RAAS ) blockade is a major renal and cardiovascular risk factor in chronic kidney disease .


Dietary sodium restriction potentiates the antiproteinuric effect of RAAS blockade , but residual proteinuria remains in many patients .


Previous studies linked high fibroblast growth factor 23 ( FGF-23 ) levels with volume overload ; others linked higher serum phosphate levels with impaired RAAS-blockade efficacy .


We hypothesized that FGF-23 reduces the capacity of dietary sodium restriction to potentiate RAAS blockade , impairing the antiproteinuric effect .


Post hoc analysis of cohort data from a randomized crossover trial with two 6-week study periods comparing proteinuria after a regular-sodium diet with proteinuria after a low-sodium diet , both during background angiotensin-converting enzyme inhibition .


47 nondiabetic patients with CKD with residual proteinuria ( median protein excretion , 1.9 [ IQR , 0.8-3 .1 ] g/d ; mean age , 5013 [ SD ] years ; creatinine clearance , 69 [ IQR , 50-110 ] mL/min ) .


Plasma carboxy-terminal FGF-23 levels .


Difference in residual proteinuria at the end of the regular-sodium versus low-sodium study period .


Residual proteinuria during the low-sodium diet period adjusted for proteinuria during the regular-sodium diet period .


Higher baseline FGF-23 level was associated with reduced antiproteinuric response to dietary sodium restriction ( standardized = -0.46 ; P = 0.001 ; model R ( 2 ) = 0.71 ) .


For every 100-RU/mL increase in FGF-23 level , the antiproteinuric response to dietary sodium restriction was reduced by 10.6 % .


Higher baseline FGF-23 level was a determinant of more residual proteinuria during the low-sodium diet ( standardized = 0.27 ; P = 0.003 ) in linear regression analysis adjusted for baseline proteinuria ( model R ( 2 ) = 0.71 ) .


There was no interaction with creatinine clearance ( P interaction = 0.5 ) .


Baseline FGF-23 level did not predict changes in systolic or diastolic blood pressure upon intensified antiproteinuric treatment .


Observational study , limited sample size .


FGF-23 levels are associated independently with impaired antiproteinuric response to sodium restriction in addition to RAAS blockade .


Future studies should address whether FGF-23-lowering strategies may further optimize proteinuria reduction by RAAS blockade combined with dietary sodium restriction .


Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism ( VTE ) in patients with active cancer largely based on results of a single , large trial .


To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute , symptomatic VTE in patients with active cancer .


A randomized , open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia , Africa , Europe , and North , Central , and South America between August 2010 and November 2013 .


Adult patients with active cancer ( defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with , or received such therapy , within the previous 6 months ) and objectively documented proximal deep vein thrombosis ( DVT ) or pulmonary embolism , with a life expectancy greater than 6 months and without contraindications for anticoagulation , were followed up for 180 days and for 30 days after the last study medication dose for collection of safety data .


Tinzaparin ( 175 IU/kg ) once daily for 6 months vs conventional therapy with tinzaparin ( 175 IU/kg ) once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range ( 2.0-3 .0 ) for 6 months .


Primary efficacy outcome was a composite of centrally adjudicated recurrent DVT , fatal or nonfatal pulmonary embolism , and incidental VTE .


Safety outcomes included major bleeding , clinically relevant nonmajor bleeding , and overall mortality .


Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses .


Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin ( 6-month cumulative incidence , 7.2 % for tinzaparin vs 10.5 % for warfarin ; hazard ratio [ HR ] , 0.65 [ 95 % CI , 0.41-1 .03 ] ; P = .07 ) .


There were no differences in major bleeding ( 12 patients for tinzaparin vs 11 patients for warfarin ; HR , 0.89 [ 95 % CI , 0.40-1 .99 ] ; P = .77 ) or overall mortality ( 150 patients for tinzaparin vs 138 patients for warfarin ; HR , 1.08 [ 95 % CI , 0.85-1 .36 ] ; P = .54 ) .


A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin ( 49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin ; HR , 0.58 [ 95 % CI , 0.40-0 .84 ] ; P = .004 ) .


Among patients with active cancer and acute symptomatic VTE , the use of full-dose tinzaparin ( 175 IU/kg ) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding , but was associated with a lower rate of clinically relevant nonmajor bleeding .


Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE .


clinicaltrials.gov Identifier : NCT01130025 .


The role of body mass index ( BMI ) in survival outcomes is controversial among lymphoma patients .


We evaluated the association between BMI at study entry and failure-free survival ( FFS ) and overall survival ( OS ) in three phase III clinical trials , among patients with diffuse large B-cell lymphoma ( DLBCL ) , follicular lymphoma ( FL ) and Hodgkin 's lymphoma ( HL ) .


A total of 537 , 730 and 282 patients with DLBCL , HL and FL were included in the analysis .


Baseline patient and clinical characteristics , treatment received and clinical outcomes were compared across BMI categories .


Among patients with DLBCL , HL and FL , the median age was 70 , 33 and 56 ; 29 % , 29 % and 37 % were obese and 38 % , 27 % and 37 % were overweight , respectively .


Age was significantly different among BMI groups in all three studies .


Higher BMI groups tended to have more favorable prognosis factors at study entry among DLBCL and HL patients .


BMI was not associated with clinical outcome with P-values of 0.89 , 0.30 and 0.40 for FFS , and 0.64 , 0.67 and 0.09 for OS , for patients with DLBCL , HL and FL , respectively .


The association remains non-significant after adjusting for other clinical factors in the Cox model .


A subset analysis of males with DLBCL treated on R-CHOP revealed no differences in FFS ( P = 0.48 ) or OS ( P = 0.58 ) .


BMI was not significantly associated with clinical outcomes among patients with DLBCL , HD or FL , in three prospective phase III clinical trials .


The findings contradict some previous reports of similar investigations .


Further work is required to understand the observed discrepancies .


Although transcatheter arterial chemoembolization ( TACE ) is the most common treatment option in patients with hepatocellular carcinoma ( HCC ) , its clinical benefits remain still controversial .


Since TACE induces hypoxic necrosis in tumors , hypoxia-inducible factor 1 ( HIF-1 ) could critically affect biology in residual tumors after TACE treatment and subsequent prognosis .


However , HIF-1 and its prognostic relevance in TACE have rarely been examined in human specimens .


In the current study , we investigated the prognosis and expression of genes regulated by HIF-1 in HCC patients receiving preoperative TACE for the first time .


In total , 35 patients with HCC ( 10 patients undergoing preoperative TACE ) were retrospectively studied .


The prognostic significance of TACE was analyzed using Kaplan-Meier and Cox regression models .


Protein levels of HIF-1 and mRNA levels of HIF-1-associated genes were examined using immunohistochemistry ( IHC ) and real-time RT-PCR , respectively .


Preoperative TACE was significantly associated with increased 2-year recurrence rate ( 80 vs. 36 % , P = 0.00402 ) and shorter disease-free survival ( DFS ) time ( 11.9 vs. 35.7 months , P = 0.0182 ) .


TACE was an independent prognostic factor for recurrence ( P = 0.007 ) and poor DFS ( P = 0.010 ) in a multivariate analysis .


Immunohistochemical staining revealed in vivo activation of HIF-1 in human specimens treated with TACE .


Notably , protein levels of HIF-1 were significantly increased in TACE tissues demonstrated by IHC .


Transcriptional targets of HIF-1 showed mRNA expression patterns consistent with activation of HIF-1 in TACE tissues .


Our findings collectively demonstrate that preoperative TACE confers poor prognosis in HCC patients through activation of HIF-1 .


There are conflicting reports on the impact of soy on breast carcinogenesis .


This study examines the effects of soy supplementation on breast cancer-related genes and pathways .


Women ( n = 140 ) with early-stage breast cancer were randomly assigned to soy protein supplementation ( n = 70 ) or placebo ( n = 70 ) for 7 to 30 days , from diagnosis until surgery .


Adherence was determined by plasma isoflavones : genistein and daidzein .


Gene expression changes were evaluated by NanoString in pre - and posttreatment tumor tissue .


Genome-wide expression analysis was performed on posttreatment tissue .


Proliferation ( Ki67 ) and apoptosis ( Cas3 ) were assessed by immunohistochemistry .


Plasma isoflavones rose in the soy group ( two-sided Wilcoxon rank-sum test , P < .001 ) and did not change in the placebo group .


In paired analysis of pre - and posttreatment samples , 21 genes ( out of 202 ) showed altered expression ( two-sided Student 's t-test , P < .05 ) .


Several genes including FANCC and UGT2A1 revealed different magnitude and direction of expression changes between the two groups ( two-sided Student 's t-test , P < .05 ) .


A high-genistein signature consisting of 126 differentially expressed genes was identified from microarray analysis of tumors .


This signature was characterized by overexpression ( > 2-fold ) of cell cycle transcripts , including those that promote cell proliferation , such as FGFR2 , E2F5 , BUB1 , CCNB2 , MYBL2 , CDK1 , and CDC20 ( P < .01 ) .


Soy intake did not result in statistically significant changes in Ki67 or Cas3 .


Gene expression associated with soy intake and high plasma genistein defines a signature characterized by overexpression of FGFR2 and genes that drive cell cycle and proliferation pathways .


These findings raise the concerns that in a subset of women soy could adversely affect gene expression in breast cancer .


The aim of this study was to examine the effect of yeast hydrolysate on the abdominal fat in obese humans .


We observed the effects of yeast hydrolysate that had a molecular weight below 10 kDa on the anti-abdominal fat accumulation in obese men and women ages 20 to 50 y for 10 wk .


The abdominal fat mass was assessed by computed tomographic scans .


By the sixth week , the reductions in energy intake in the yeast group ( yeast hydrolysate 1 g/d ) were significantly greater than those in the control group ( placebo 1 g/d ) ( P < 0.05 ) .


The body weight and body mass index ( BMI ) were significantly reduced by week 10 compared with baseline in the yeast group , and these differences were significantly greater than those in the control group : body weight 0.83 kg versus -2.60 k g ( P < 0.001 ) , BMI 0.29 kg/m ( 2 ) versus -0.90 kg/m ( 2 ) ( P < 0.001 ) .


Despite the increased loss of body weight in the yeast group , lean body mass did not significantly differ between the two groups .


Body fat mass in the control group did not significantly change between baseline and week 10 .


However , the yeast group lost a significant amount of body fat mass after 10 wk of treatment ( P < 0.01 ) .


The differences in abdominal fat thickness and abdominal circumference between the two groups were significant after 10 wk of treatment ( P < 0.001 ) .


The total abdominal fat area in the yeast group was significantly lower than in the control group after 10 wk of treatment ( -7.06 cm ( 2 ) versus -17.34 cm ( 2 ) ; P < 0.01 ) .


Yeast hydrolysate can reduce body weight and the accumulation of abdominal fat without an adverse effect on lean body mass in obese adults , regardless of sex , via the reduction of energy intake .


Delirium is a frequent disorder in intensive care unit ( ICU ) patients with serious consequences .


Therefore , preventive treatment for delirium may be beneficial .


Worldwide , haloperidol is the first choice for pharmacological treatment of delirious patients .


In daily clinical practice , a lower dose is sometimes used as prophylaxis .


Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality , but evidence for effectiveness in ICU patients is limited .


The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival .


Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis .


This will be a multicenter three-armed randomized , double-blind , placebo-controlled , prophylactic intervention study in critically ill patients .


We will include consecutive non-neurological ICU patients , aged 18 years with an expected ICU length of stay > 1 day .


To be able to demonstrate a 15 % increase in 28-day survival time with a power of 80 % and alpha of 0.05 in both intervention groups , a total of 2,145 patients will be randomized ; 715 in each group .


The anticipated mortality rate in the placebo group is 12 % .


The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h , and patients in the control group will receive placebo ( sodium chloride 0.9 % ) , both for a maximum period of 28-days .


In patients who develop delirium , study medication will be stopped and patients will subsequently receive open label treatment with a higher ( therapeutic ) dose of haloperidol .


We will use descriptive summary statistics as well as Cox proportional hazard regression analyses , adjusted for covariates .


This will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium , adequately powered to demonstrate an effect on 28-day survival .


Clinicaltrials.gov : NCT01785290.EudraCT number : 2012-004012-66 .


Intranasal ( IN ) insulin acutely improves verbal memory in mild cognitive impairment ( MCI ) / Alzheimer 's disease ( AD ) , but its therapeutic effects may be attenuated in apolipoprotein E4 ( ApoE4 ) carriers .


Furthermore , rapid-acting ( RA ) insulins may have superior therapeutic effects compared with regular insulin types .


To measure the safety and efficacy of intranasally delivered RA glulisine in ApoE4 carriers with mild-moderate AD .


We performed a double-blinded , randomized , cross-over study of RA insulin glulisine in nine mild-moderate AD subjects to better understand the relationship between RA insulin , ApoE4 carrier status and memory performance .


IN glulisine was well tolerated but failed to have an acute impact on cognition in ApoE4 carriers with AD .


Serum insulin levels acutely dropped following treatment , but peripheral glucose levels remained unchanged .


Larger clinical trials of longer duration are necessary to better understand the relationships between RA insulin , ApoE4 carrier status and cognitive performance in AD .


Health-promoting lifestyle choices of adolescents are closely related to current and subsequent health status .


However , parsimonious yet reliable and valid screening tools are scarce .


The original 40-item adolescent health promotion ( AHP ) scale was developed by our research team and has been applied to measure adolescent health-promoting behaviors worldwide .


The aim of our study was to examine the psychometric properties of a newly developed short-form version of the AHP ( AHP-SF ) including tests of its reliability and validity .


The study was conducted in nine middle and high schools in southern Taiwan .


Participants were 814 adolescents randomly divided into two subgroups with equal size and homogeneity of baseline characteristics .


The first subsample ( calibration sample ) was used to modify and shorten the factorial model while the second subsample ( validation sample ) was utilized to validate the result obtained from the first one .


The psychometric testing of the AHP-SF included internal reliability of McDonald 's omega and Cronbach 's alpha , convergent validity , discriminant validity , and construct validity with confirmatory factor analysis ( CFA ) .


The results of the CFA supported a six-factor model and 21 items were retained in the AHP-SF with acceptable model fit .


For the discriminant validity test , results indicated that adolescents with lower AHP-SF scores were more likely to be overweight or obese , skip breakfast , and spend more time watching TV and playing computer games .


The AHP-SF also showed excellent internal consistency with a McDonald 's omega of 0.904 ( Cronbach 's alpha 0.905 ) in the calibration group .


The current findings suggest that the AHP-SF is a valid and reliable instrument for the evaluation of adolescent health-promoting behaviors .


Primary health care providers and clinicians can use the AHP-SF to assess these behaviors and evaluate the outcome of health promotion programs in the adolescent population .


We ( 1 ) evaluated the impact of an evidence-based HIV prevention program with and without a parent component among mid-adolescents living in the Caribbean and ( 2 ) determined the effect of prior receipt of a related intervention during preadolescence on intervention response .


A randomized , controlled 4-cell trial of a 10-session , theory-based HIV prevention intervention involving 2564 Bahamian grade-10 youths ( some of whom had received a comparable intervention in grade 6 ) was conducted ( 2008-2011 ) .


Randomization occurred at the level of the classroom with follow-up at 6 , 12 , and 18 months after intervention .


The 3 experimental conditions all included the youths ' curriculum and either a youth-parent intervention emphasizing adolescent-parent communication , a parent-only goal-setting intervention , or no parent intervention .


An intervention delivered to mid-adolescents in combination with a parent-adolescent sexual-risk communication intervention increased HIV/AIDS knowledge , condom-use skills , and self-efficacy and had a marginal effect on consistent condom use .


Regardless of prior exposure to a similar intervention as preadolescents , youths benefited from receipt of the intervention .


Preadolescents and mid-adolescents in HIV-affected countries should receive HIV prevention interventions that include parental participation .


Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment , yet few interventions have been evaluated to reduce this risk .


Purple grape juice ( pGJ ) , a rich source of flavonoids with antioxidant properties , has been shown in adults to reduce oxidative stress and improve endothelial function .


We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors ( ages 10-21 years ) .


In a randomized controlled crossover trial consisting of two , 4 week intervention periods , each preceded by a 4 week washout period , subjects received in random order 6 ounces twice daily of pGJ and clear apple juice ( cAJ ; similar in calories but lower in flavonoids ) .


Measurements were obtained before and after each supplementation period ; change was evaluated using mixed effects ANOVA .


pGJ did not improve endothelial function , measured using digital reactive hyperemia , compared with cAJ ( mean change : pGJ 0.06 , cAJ 0.22 ; difference of mean change [ 95 % CI ] : -0.16 [ -0.42 - 0.11 ] , P = 0.25 ) .


No significant changes in plasma concentrations of oxidized-LDL , myeloperoxidase , or high sensitivity C-reactive protein were observed .


After 4 weeks of daily consumption of flavonoid-rich pGJ , no measurable change in vascular function was observed in these childhood cancer survivors .


The development of secondary non-response ( SNR ) to botulinum neurotoxin type-A ( BoNT-A ) is considered a key issue in the management of cervical dystonia ( CD ) .


This case-controlled study was performed to systematically identify factors influencing SNR during BoNT-A therapy .


This was a retrospective , international , non-interventional study of CD patients .


Patients with SNR were matched with up to three responder patients ( control ) on the basis of duration of therapy and number of injection cycles .


Factors influencing the development of SNR were screened using a univariate logistic regression model and confirmed using a multivariate conditional logistic regression model .


216 patients were enrolled , and 201 ( SNR = 52 ; responder = 149 ) were matched and subdivided into blocks ( doublets , triplets or quadruplets ) .


At baseline , a significantly higher proportion of SNR patients had received previous or concomitant therapies ( p = 0.038 ) and surgery for CD ( p = 0.007 ) compared with controls .


Although disease severity at onset was similar between groups , a significantly higher proportion of SNR patients experienced severe CD at the time of SNR compared with controls at the last documented visit .


Multivariate analyses identified five factors that were significantly associated in predicting SNR ( odds ratio [ OR ] > 1 indicated higher chances for being SNR ) : previous surgical procedure for CD ( OR 9.8 , p = 0.013 ) , previous BoNT-A related severe adverse event ( AE ) ( OR 5.6 p = 0.027 ) , physical therapy ( OR 4.6 , p = 0.028 ) , neuroleptic use ( OR 3.3 , p = 0.019 ) and average BoNT-A dose ( OR 2.7 , p = 0.010 ) .


These findings suggest that SNR may not reflect true pharmacological resistance to BoNT-A therapy , but may be related to underlying disease severity .


Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years .


However , previous research has not yet shown that acupuncture is effective as a stroke treatment .


We report a protocol for a multicenter , randomized , controlled , and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke .


In a prospective trial involving three hospitals in the Zhejiang Province ( China ) 250 patients with a recent ( less than 1 week previous ) episode of ischemic stroke will be included .


Patients will be randomized into two groups : an acupuncture group given scalp acupuncture and electroacupuncture , and a control group given no acupuncture .


Eighteen treatment sessions will be performed over a three-week period .


The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one , three , and four-week follow-up .


Secondary outcome measures will be : 1 ) the Fugl-Meyer assessment scale for motor function ; 2 ) the mini-mental state examination and Montreal cognitive assessment for cognitive function ; 3 ) the video-fluoroscopic swallowing study for swallowing ability ; and 4 ) the incidence of adverse events .


This trial is expected to clarify whether or not acupuncture is effective for acute stroke .


It will also show if acupuncture can improve motor , cognitive , or swallowing function .


Chinese Clinical Trial Registry ChiCTR-TRC-12001971 .


The extant literature on predictors of treatment response to behavioral treatments for insomnia is equivocal and limited in scope .


The current study examined demographic , clinical , and sleep characteristics as predictors of clinically significant treatment response to brief behavioral treatment of insomnia ( BBTI ) in older adults with insomnia .


Thirty-nine older adults with insomnia ( 67 % females , mean age : 72.54 years ) were randomized to BBTI treatment .


Treatment outcomes were defined according to 2 criteria : ( 1 ) `` response , '' defined as change in Pittsburgh Sleep Quality Index ( PSQI ) score 3 points or increase in sleep diary sleep efficiency 10 % ) ; or ( 2 ) remission , defined as absence of a clinical diagnosis of insomnia according to standard diagnostic criteria .


Logistic regression examined whether baseline demographic , clinical , or sleep characteristics predicted treatment outcomes at 1 month follow-up .


Demographic variables did not predict treatment outcomes for either criterion .


Higher anxiety , depression , poorer sleep quality , and longer polysomnography ( PSG ) - assessed sleep latency predicted greater likelihood of response at follow-up ( p < 0.05 ) .


Longer sleep duration at baseline ( measured by sleep diary and PSG ) predicted greater likelihood of the remission at follow-up ( p < 0.05 ) .


Patients with insomnia who have greater distress at baseline or prolonged sleep latency are more likely to show positive response to BBTI .