Patients with end-stage renal failure ( ESRF ) need integrated health care to maintain a desirable quality of life .


Studies suggest that post-discharge nurseled telephone support has a positive effect for patients suffering from chronic diseases .


But the post-discharge care is under-developed in mainland China and the effects of post-discharge care on patients with peritoneal dialysis have not been conclusive .


The purpose of this study is to test the effectiveness of postdischarge nurse-led telephone support on patients with peritoneal dialysis in mainland China .


A randomized controlled trial was conducted in the medical department of a regional hospital in Guangzhou .


@ patients were recruited , @ in the study group and @ in the control group .


The control group received routine hospital discharge care .


The study group received post-discharge nurse-led telephone support .


The quality of life ( Kidney Disease Quality of Life Short Form , KDQOL-SF ) , blood chemistry , complication control , readmission and clinic visit rates were observed at three time intervals : baseline before discharge ( T@ ) , @ ( T@ ) and @ ( T@ ) weeks after discharge .


Statistically significant effects were found for symptom/problem , work status , staff encouragement , patient satisfaction and energy/fatigue in KDQOL-SF and @-day ( @-week ) clinic visit rates between the two groups .


The study group had more significant improvement than the control group for sleep , staff encouragement at both T@ and T@ , and pain at T@ and patient satisfaction at T@ .


No significant differences were observed between the two groups for the baseline measures , other dimensions in KDQOL-SF , blood chemistry , complication control , readmission rates at all time intervals and clinic visit rates at the first two time intervals .


Post-discharge nurse-led telephone support for patients undergoing peritoneal dialysis is effective to enhance patients ' well-being in the transition from hospital to home in mainland China .


Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity .


This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment .


Overall , @ previously untreated stage II-III operable breast cancer patients were randomized to receive either standard treatment ( arm A , n = @ ) , consisting of fluorouracil , epirubicin , and cyclophosphamide ( FEC@ : @ , @ , and @ mg/m ( @ ) , respectively , for @ cycles ) followed by docetaxel ( @ mg/m ( @ ) for @ cycles ) , or adapted treatment ( arm B , n = @ ) , beginning with @ cycles of FEC@ and switching to docetaxel if tumor size decreased by < @ % after @ cycles or < @ % after @ cycles of FEC@ ( ultrasound assessments according to World Health Organization criteria ) .


Otherwise , FEC@ was given for six cycles before surgery .


Intent-to-treat analysis was performed .


Similar results were observed for clinical response ( objective response was @ % vs @ % , p = @ ) , breast conservation surgery ( BCS ; @ % vs @ % , p = @ ) , and pathological complete response rate ( Chevallier classification : @ % vs @ % , p = @ ; Statloff classification : @ % vs @ % , p = @ ) between arms A and B. Similar toxicities were observed , even with unbalanced numbers of FEC@ and docetaxel courses .


Adapted and standard treatments had similar results in terms of tumor response , BCS rate , and tolerability .


Further survival outcome data are expected .


To evaluate the influence of at least three abutment changes against the placement of a definitive abutment , which was no longer removed , on hard and soft tissue changes , and to compare the clinical outcomes of immediate non-occlusal loading versus conventional loading .


Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised , after implants were placed with more than @ Ncm , according to a parallel group design to receive definitive abutments which were loaded immediately ( definitive abutment or immediate loading group ) or transmucosal abutments which experienced delayed loading after @ months and were removed at least three times : @ ) during the making of the impression ( @ months after implant placement ) ; @ ) when checking the zirconium core of titanium abutments at single crowns or the fitting of the metal structure at prostheses supported by multiple implants ; @ ) at delivery of the definitive prostheses ( repeated disconnection or conventional loading group ) .


Patients were treated in four centres and each patient contributed to the study with only one prosthesis followed for @ months after initial loading .


Outcome measures were : prosthesis/implant failures , any complication , peri-implant marginal bone level changes , and patient satisfaction .


Forty patients were randomly allocated to each group according to a parallel group design .


No patient dropped-out and no implants failed .


However four provisional prostheses and one definitive prosthesis had to be remade because of misfitting ( five single crowns ) in the repeated disconnection group ; and one provisional prosthesis had to be remade because of frequent debondings in the immediate loading group ( difference = @ % ; @ % CI : -@ % , @ % ; P = @ ) .


Five complications ( all debondings of the provisional prostheses ) were reported in two patients of the immediate loading group , in comparison to three biological complications in three patients of the repeated disconnection group ( difference = @ % ; @ % CI : -@ % , @ % ; P = @ ) .


All patients were very satisfied or satisfied with the function and aesthetics of the prostheses , and would undergo the same procedure again .


Mean peri-implant marginal bone loss @ months after loading was -@ ( @ ) mm for the definitive abutment group and -@ ( @ ) mm for the repeated abutment changes group ( difference = @ ; @ % CI : -@ , @ ; P = @ ) .


There were no statistically significant differences for any of the outcome measures between the two procedures up to @ months after initial loading .


Preliminary short-term data ( @-month post-loading ) showed that repeated abutment changes do not alter bone levels significantly .


Immediate non-occlusal loading of dental implants are a viable alternative to conventional loading .


Therefore clinicians can use the procedure they find more convenient for their specific patient .


To observe the efficacy difference of electroacupuncture and auricular acupuncture in the treatment of methamphetamine withdrawal syndrome .


Ninety male patients of methamphetamine addiction were randomized into an electroacupuncture group , an auricular acupuncture group and a control group , @ cases in each one .


In the electroacupuncture group , Neiguan ( PC @ ) , Shenmen ( HT @ ) , Zusanli ( ST @ ) , Sanyinjiao ( SP @ ) , Jiaji ( EX-B @ ) at T@ and L@ were selected bilaterally .


In the auricular acupuncture group , jiaogan ( AH ( @a ) ) , shenmen ( TF@ ) , fei ( CO@ ) and gan ( CO@ ) were selected unilaterally .


The treatment was given @ times a week , totally @ treatments were required .


In the control group , no any intervention was applied .


Separately , before treatment and after @ , @ , @ and @ weeks treatment , the scores of methamphetamine withdrawal syndrome , Hamilton anxiety scale and Hamilton depression scale were observed in each group .


The total score of methamphetamine withdrawal syndrome , anxiety score and depression score were obviously reduced in @ , @ and @ weeks of treatment as compared with those before treatment in the electroacupuncture group and the auricular acupuncture group ( all P < @ ) , and showed a trend of gradual decline as the extension of treatment .


In @,@,@,@ weeks of treatment , the total score of withdrawal syndrome , anxiety score and depression score in the electroacupuncture group and auricular acupuncture group were lower significantly than those in the control group ( all P < @ ) , in which , the total score of withdrawal syndrome in the electroacupuncture group was lower significantly than that in the auricular acupuncture group in the @th week of treatment ( @ + / - @ vs @ + / - @ , P < @ ) ; the anxiety scores were lower significantly than those in the auricular acupuncture group in @ and @ weeks of treatment ( @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , both P < @ ) ; the depression scores were lower significantly than those in the auricular acupuncture group in @ , @ and @ weeks of treatment ( @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , all P < @ ) .


Electroacupuncture at the body points and auricular acupuncture play the therapeutic role in the treatment of methamphetamine withdrawal syndrome , anxiety and depression .


The longer time the treatment is with electroacupuncture at the body points , the more obvious the efficacy will be on the above symptoms .


Influenza vaccination coverage for U.S. school-aged children is below the @ % national goal .


Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season .


No real-world models of school-located seasonal influenza ( SLV-I ) programs have been tested .


Determine the feasibility , sustainability , and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day .


In this pragmatic randomized controlled trial of SLV-I during two vaccination seasons , schools were randomly assigned to SLV-I versus standard of care .


Seasonal influenza vaccine receipt , as recorded in the state immunization information system ( IIS ) , was measured .


Intervention and control schools were located in a single western New York county .


Participation ( intervention or control ) included the sole urban school district and suburban districts ( five in Year @ , four in Year @ ) .


After gathering parental consent and insurance information , live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day .


Data on receipt of @ seasonal influenza vaccination in Year @ ( @-@ ) and Year @ ( @-@ ) were collected on all student grades K through @ at intervention and control schools from the IIS in the Spring of @ and @ , respectively .


Additionally , coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere .


Preliminary data analysis for Year @ occurred in Spring @ ; final quantitative analysis for both years was completed in late Fall @ .


Results are shown for @-@ and @-@ , respectively : Children enrolled in suburban SLV-I versus control schools had vaccination coverage of @ % vs @ % , and @ % vs @ % ( p < @ both years ) .


In urban areas , coverage was @ % vs @ % , and @ % vs @ % ( p < @ both years ) .


On multilevel logistic analysis with three nested levels ( student , school , school district ) during both vaccination seasons , children were more likely to be vaccinated in SLV-I versus control schools ; ORs were @ ( @ % CI = @ , @ ; p < @ ) and @ ( @ % CI = @ , @ ; p < @ ) .


Delivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage .


Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson 's disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy .


A randomized single-blind controlled trial .


Outpatients .


Thirty-four patients with Parkinson 's disease in Hoehn-Yahr stage @-@ .


Group @ hydrotherapy treatment , group @ land-based rehabilitation treatment .


The two groups underwent the same rehabilitation period ( @ minutes of treatment , five days a week for two months ) .


The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes , using a stabilometric platform .


Secondary outcome measures were Unified Parkinson 's Disease Rating Scale II and III , Timed Up and Go Test , Berg Balance Scale , Activities-specific Balance Confidence Scale , Falls Efficacy Scale , Falls diary and Parkinson 's Disease Questionnaire-@ .


Hydrotherapy treatment proved to be feasible and safe .


Patients in both groups had a significant improvement in all outcome variables .


There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes ( mean SD change : @ SD@ @ vs. @ SD@ @ , p = @ ) , Berg Balance Scale ( @ SD@ @ vs. @ SD@ @ , p = @ ) , Activities-specific Balance Confidence Scale ( @ SD@ @ vs. @ SD@ @ , p = @ ) , Falls Efficacy Scale ( -@ SD@ @ vs. -@ SD@ @ , p = @ ) , Parkinson 's Disease Quetionnaire-@ ( -@ SD@ @ vs. -@ SD@ @ , p = @ ) and falls diary ( -@ SD@ @ vs. -@ SD@ @ , p = @ ) .


Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease .


To compare the demographic characteristics and intra - and postoperative outcomes in elderly adults ( @ ) with those of younger adults undergoing early ( < @ days after onset of complaints ) cholecystectomy .


Retrospective analysis from May @ to August @ .


Randomized , multicenter , clinical trial ( ABCAL Study , NCT@ ) .


Individuals with mild or moderate acute calculous cholecystitis ( ACC ) according to the Tokyo Guidelines ( N = @ ; n = @ aged @-@ , median @ ; n = @ aged @-@ , median @ ) .


Demographic characteristics and pre - , intra - , and postoperative data .


The elderly group was more likely to have an American Society of Anesthesiologists score of @ or greater ( @ % vs @ % , P < @ ) , higher serum creatinine ( @ vs @ mol/L , P < @ ) , and more-severe ACC ( moderate ACC ( @ % vs @ % , P = @ ) , gangrenous cholecystitis ( @ % vs @ % , P = @ ) ) on preoperative imaging and confirmed intraoperatively .


Ulcerated mucosa ( @ % vs @ % , P = @ ) was significantly more frequent in the elderly group .


Operative time , postoperative mortality , and postoperative infectious ( @ % vs @ % , P = @ ) and noninfectious ( @ % vs @ % , P = @ ) complications were similar between the two groups .


Median length of stay ( @ vs @ days , P = @ ) and readmission rate ( @ % vs @ % , P = @ ) were not significantly higher in the elderly group .


No significant difference was observed for the subgroup of participants aged @ and older .


In this randomized trial that included a selected sample of older adults , there was no difference in major outcomes between elderly adults and their younger counterparts after early cholecystectomy .


The findings are limited because important geriatric outcomes such as delirium and functional decline were not examined .


The aim of present study was to find a better procedure to prevent synkinesis in facial nerve palsy .


A randomized clinical trial .


Clinical rehabilitation faculty and general rehabilitation centers .


Twenty - nine patients with facial nerve palsy were selected via electrodiagnosis tests .


The experimental group ( n = @ ) was treated with biofeedback electromyography , whereas the control group ( n = @ ) received common physiotherapy .


All patients received @-year treatment .


Evaluation of facial grading scale before and after treatment and severity of synkinesia .


At the end of treatment , there was a rise in facial grading system in both groups compared with baseline ( p < @ , paired t test ) .


There were significant differences in the facial grading system between @ groups at the end of the study , but the experimental group showed better result than the other one .


The number of patients with synkinesis and the severity of their synkinesis in the experimental group were lesser than those of the control group .


Biofeedback therapy is more efficient than common physiotherapy .


By using this approach , controlling and reducing synkinesis is more feasible .


The aim of study was to evaluate setting-specific quality indicators ( QIs ) for shared-housing arrangements ( SHA ) regarding effects of a guided quality development process on resident 's quality of life ( QoL ) .


SHA are a specific German kind of small-scale living facilities for care-dependent persons with dementia .


SHA are disconnected from residential facilities and served by community care services .


In a longitudinal cluster-randomised design @ residents of @ SHA were surveyed for @ year ; the intervention group took part in a quality development process .


QIs , physical and psychological health outcomes including QoL were surveyed .


During the @ year follow-up , analyses show a positive trend regarding QI-outcomes in the intervention group , but no statistically significant differences could be proved regarding QoL .


Setting-sensitive QIs are absolutely essential to measure quality of care in multi-professional settings like SHA .


Further research as well as longer study intervals is essential .


In clinical trials , treatment with a combination of the nucleotide polymerase inhibitor sofosbuvir and the antiviral drug ribavirin was associated with high response rates among patients with hepatitis C virus ( HCV ) genotype @ infection , with lower response rates among patients with HCV genotype @ infection .


We conducted a study involving patients with HCV genotype @ or @ infection , some of whom had undergone previous treatment with an interferon-based regimen .


We randomly assigned @ patients with HCV genotype @ infection and @ with HCV genotype @ infection , in a @:@ ratio , to receive sofosbuvir-ribavirin or placebo for @ weeks .


On the basis of emerging data from phase @ trials indicating that patients with HCV genotype @ infection had higher response rates when they were treated for @ weeks , as compared with @ weeks , the study was unblinded , treatment for all patients with genotype @ infection was extended to @ weeks , the placebo group was terminated , and the goals of the study were redefined to be descriptive and not include hypothesis testing .


The primary end point was a sustained virologic response at @ weeks after the end of therapy .


Of the @ patients who were enrolled and treated , @ % had cirrhosis and @ % had received previous interferon-based treatment .


The criterion for a sustained virologic response was met in @ of @ patients ( @ % ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) with HCV genotype @ infection who were treated for @ weeks and in @ of @ patients ( @ % ; @ % CI , @ to @ ) with HCV genotype @ infection who were treated for @ weeks .


Among patients with HCV genotype @ infection , response rates were @ % and @ % among those without and those with cirrhosis , respectively .


The most common adverse events were headache , fatigue , and pruritus .


Therapy with sofosbuvir-ribavirin for @ weeks in patients with HCV genotype @ infection and for @ weeks in patients with HCV genotype @ infection resulted in high rates of sustained virologic response .


( Funded by Gilead Sciences ; VALENCE ClinicalTrials.gov number , NCT@ . )


Herbal remedies play an important role in treatment of psychiatric disorders .


The aim of this study was to assess the efficacy of crocin , the main active constituent of saffron , as an adjunctive treatment in major depressive disorder ( MDD ) .


This study was a randomized , double-blind , placebo-controlled , pilot clinical trial .


It was carried out during @ weeks in two groups ( placebo and treatment ) on @ MDD patients between @ and @ years old in Ibn-e-Sina psychiatric hospital , Mashhad , Iran , from March @ to December @ .


The crocin group ( n = @ ) was given one selective serotonin reuptake inhibitor ( SSRI ) drug ( fluoxetine @mg/day or sertraline @mg/day or citalopram @mg/day ) plus crocin tablets ( @mg/day ; @mg BID ) and placebo group ( n = @ ) was administered one SSRI ( fluoxetine @mg/day or sertraline @mg/day or citalopram @mg/day ) plus placebo ( two placebo tablets per day ) for @ weeks .


Both groups filled beck depression inventory ( BDI ) , beck anxiety inventory ( BAI ) , general health questionnaire ( GHQ ) , the mood disorder questionnaire ( MDQ ) , side effect evaluation questionnaire , and demographic questionnaire before and after one month intervention .


The crocin group showed significantly improved scores on BDI , BAI and GHQ compared to placebo group ( Pvalue < @ ) .


The averages of decrease in BDI , BAI and GHQ scores in placebo group were @ , @ and @ respectively , whereas the values in crocin group were @ , @ and @ after @ weeks trial .


Poor patient compliance with medications and short trial period , small sample size and self-report assessments were the major limitations of this study .


These results demonstrated the effect of crocin in depression and could be administered in treatment of MDD patients .


We aimed to determine the relationship between blood lactate , carboxy-hemoglobin ( COHb ) levels and the severity of clinical findings in patients with CO poisoning .


Patients over @ years old and of both gender who were admitted to Emergency Department with the diagnosis of CO poisoning between @ and @ were enrolled in this study .


Detailed physical examination of each patient was performed , patients and their relatives were informed about the study and written consents were noted .


The levels of consciousness , physical examination findings , electrocardiographic findings , Glasgow Coma Scale ( GCS ) scores , laboratory results ( lactate , COHb , CK-MB , Troponin-I levels ) and applied treatments -LSB- normobaric oxygen therapy ( NBOT ) , hyperbaric oxygen therapy ( HBOT ) -RSB- were recorded to standart data entry form for each patient .


SPSS for Windows version @ package program was used for statistical analysis of the data .


Total @ patients were included in this study .


Thirty five patients ( @ % ) received HBOT and lactate , COHb , CKMB , Troponin-I levels of this group were higher than the other patients .


Lactate and COHb levels were statistically significantly higher in patients with GCS < @ than the ones with GCS = @ ( p < @ ) .


The patients whose both Troponin-I and CK-MB levels increased have higher lactate levels ( p = @ ) , but COHb levels of these patients did not change ( p = @ ) .


According to our study , blood lactate and COHb levels were both correlated with the changes of consciousness in CO poisoning .


Blood lactate levels together with COHb in defining indications for HBO treatment might be suggested .


Internet-based cognitive behavioural therapy ( ICBT ) is a promising approach to the prevention and reduction of depressive symptoms among adolescents .


This study aimed to evaluate the feasibility and efficacy of disseminating a self-directed internet-based mental health intervention ( MoodGYM ) in senior high schools .


It also sought to investigate possible effects of tailored and weekly e-mail reminders on initial uptake and adherence to the intervention .


A baseline survey was conducted in four senior high schools in two Norwegian municipalities ( n = @ ) .


@ % ( @/@ ) of the students consented to further participation in the trial and were randomly allocated to one of three MoodGYM intervention groups ( tailored weekly e-mail reminder ( n = @ ) , standardized weekly e-mail reminder ( n = @ ) or no e-mail reminder ( n = @ ) ) or a waitlist control group ( n = @ ) .


We tested for effects of the intervention on depression and self-esteem using multivariate analysis of variance , effects of tailored e-mail and self-reported current need of help on initial uptake of the intervention using logistic regression and the effect of weekly e-mails on adherence using ordinal regression .


There was substantial non-participation from the intervention , with only @ % ( @/@ ) participants logging on to MoodGYM , and few proceeding beyond the first part of the programme .


No significant effect on depression or self-esteem was found among the sample as a whole or among participants with elevated depression scores at baseline .


Having a higher average grade in senior high school predicted initial uptake of the intervention , but tailored e-mail and self-reported current need of help did not .


Weekly e-mail prompts did not predict adherence .


The main reasons for non-use reported were lack of time/forgetting about it and doubt about the usefulness of the program .


Overall , disseminating a self-directed internet-based intervention to a school population proved difficult despite steps taken to reduce barriers in terms of tailoring feedback and dispatching weekly e-mail reminders .


Providing mental health interventions within the school environment is likely to ensure better uptake among senior high school students , but there is a need to effectively communicate that such programmes can be helpful .


Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age .


Worldwide , knee osteoarthritis is one of the leading causes of disability , particularly in the elderly .


In numerous trials of agents for long-term pain therapy , no well-established and replicable results have been achieved .


Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain .


Among herbal medicines , the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis , as it causes few adverse effects .


The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis .


This study will be a multicenter randomized , double-blind , placebo-controlled trial .


A total of @ participants aged @ to @ years with knee osteoarthritis , whose scores on a visual analog scale ( VAS ) are more than @ mm , will be randomly allocated into a treatment group and a control group .


A golden plaster will be administered externally to participants in the treatment group for @ weeks , while the control group will receive a placebo plaster externally for @ weeks .


Follow-up will be at regular intervals during a @-week period with a VAS score for pain , quality of life , and complications .


This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster , compared to a placebo intervention in patients with knee osteoarthritis .


Tenofovir disoproxil fumarate ( TDF ) pre-exposure prophylaxis decreases sexual acquisition of HIV infection .


We sought to evaluate the renal safety of TDF in HIV-uninfected persons .


The Iniciativa Profilaxis Pre-Exposicin ( iPrEx ) study randomly assigned @ HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily TDF coformulated with emtricitabine ( FTC/TDF ) or placebo .


Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured , and creatinine clearance ( CrCl ) was estimated by the Cockcroft-Gault equation .


Indicators of proximal renal tubulopathy ( fractional excretion of phosphorus and uric acid , urine protein , and glucose ) were measured in a substudy .


There was a small but statistically significant decrease in CrCl from baseline in the active arm , compared to placebo , which was first observed at week @ ( mean change : -@ vs. -@ ml/min ; P = @ ) , persisted through the last on-treatment visit ( mean change : +@ vs. +@ ml/min ; P = @ ) , and resolved after stopping pre-exposure prophylaxis ( mean change : -@ vs. @ ml/min ; P = @ ) .


The effect was confirmed when stratifying by drug detection .


The effect of FTC/TDF on CrCl did not vary by race , age , or history of hypertension .


There was no difference in serum phosphate trends between the treatment arms .


In the substudy , two participants receiving placebo had indicators of tubulopathy .


In HIV-seronegative MSM , randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring .


Statin use is frequently associated with muscle-related symptoms .


Coenzyme Q@ supplementation has yielded conflicting results in decreasing statin myopathy .


Herein , we tested whether coenzyme Q@ supplementation could decrease statin-associated muscular pain in a specific group of patients with mild-to-moderate muscle symptoms .


Fifty patients treated with statins and reporting muscle pain were recruited .


The Q@ group ( n = @ ) received coenzyme Q@ supplementation over a period of @ days ( @ mg twice daily ) , and the control group ( n = @ ) received placebo .


The Brief Pain Inventory ( BPI ) questionnaire was used and blood testing was performed at inclusion in the study and after @ days of supplementation .


The intensity of muscle pain , measured as the Pain Severity Score ( PSS ) , in the Q@ group was reduced from @ to @ ( P < @ ) .


The Pain Interference Score ( PIS ) after Q@ supplementation was reduced from @ to @ ( P < @ ) .


In the placebo group , PSS and PIS did not change .


Coenzyme Q@ supplementation decreased statin-related muscle symptoms in @ % of patients .


The relative values of PSS and PIS significantly decreased ( -@ % and -@ % , respectively ) in the Q@ group compared to placebo group ( both P < @ ) .


From baseline , no differences in liver and muscle enzymes or cholesterol values were found .


The present results show that coenzyme Q@ supplementation ( @ mg twice daily ) effectively reduced statin-related mild-to-moderate muscular symptoms , causing lower interference of statin-related muscular symptoms with daily activities .


To observe the clinical effect of Guilu Erxian Glue Cataplasm ( GEGC ) on carcinoma of the large intestine patients with myelosuppression after chemotherapy , and further to confirm its efficiency and safety .


Totally @ patients with carcinoma of the large intestine were randomly assigned to two groups .


Meanwhile , they all accepted FOLFIRI chemotherapy .


Patients in the treatment group were additionally applied at Shenque ( RN@ ) , exchanging once per every other day , for @ successive days .


Patients in the control group took placebos with the same dose and dosage as the treatment group .


The blood cell counts ( WBC , NE , and PLT ) were detected before chemotherapy , at day @ , @ , and @ .


The TCM symptoms integrals , Karnofsky performance score ( KPS ) , liver and kidney functions were observed before chemotherapy , at day @ and day @ .


Adverse skin reactions were observed each day .


And the usage of hematopoietic growth factors was recorded .


( @ ) The KPS score at day @ was more stable in the treatment group than in the control group ; the WBC and NE counts in the peripheral blood at day @ were higher in the treatment group than in the control group ; and TCM symptoms integrals at day @ was lower in the treatment group than in the control group , all with statistical difference ( P < @ ) .


( @ ) Compared with the control group , the PLT count was higher in the treatment group than in the control group , the usage of rhG-CSF and antibiotics was less in the treatment group than in the control group , all with no statistical difference ( P > @ ) .


( @ ) No obvious adverse reactions such as liver injury , renal injury , or skin allergy were observed .


Adjuvant treatment of GEGC could improve carcinoma of the large intestine patients with myelosuppression to some extent .


No relevant adverse reactions were found .


The health system responsiveness , defined as non-medical aspect of treatment relating to the protection of the patients ' legitimate rights , is the intrinsic goal of the WHO strategy for @st century .


To describe the patients ' opinions on treatment they received in hospital , namely : admission to hospital , the role of patient in hospital treatment , course of treatment , medical workforce attitude , hospital environment , contact with family and friends , and the efficacy of hospital treatment in respect to responsiveness to patient 's needs and expectations ( dignity , autonomy , confidentiality , communication , prompt attention , social support , basic amenities and choice of provider ) .


The data were collected in @ from @ former patients of the randomly selected @ hospital in Poland .


Dignity : Over @ % of patients experienced kindness , empathy , care and gentleness , and over @ % of them had the sense of security in hospital , met with friendliness during the admission to hospital and never encountered inappropriate comments from medical staff .


Autonomy : About @ % of patients accepted the active role of patients in hospital , they perceived they had influence on procedures related to hospitalization and course of treatment , and they felt medical staff responded to their requests and concerns .


Over @ % of them had opportunity to communicate their concerns to medical staff and to discuss the course of treatment .


On the other hand , the explanation of the reason for the refusal to meet their requests was given to only @ % of the patients interested .


Confidentiality : @-@ % of patients declared the respect for privacy and confidentiality during collecting the health information and during medical examinations , and were not examined in presence of other people .


Nevertheless , only @ % of patients examined so were asked of their consent .


Communication : About @ % of patients declared they trusted their physician , received from him explanation regarding the course of treatment and information about further treatment after discharge from hospital , but physicians devoted the time and attention to only @ % of them .


Prompt attention : Over @ % of patients perceived simplicity of the formalities of admission to hospital , and short waiting for treatment and additional tests in hospital ( but only @ % received explanation of reason if they waited long ) .


Nevertheless , @ % of them % of them perceived they waited for admission to hospital too long , and over @ % for admission to a ward as long .


Social support : The unlimited direct and phone contact with family and friends was declared by @ % of patients .


Basic amenities : The high percentage of patients assessed positively the marking in hospital ( @ % ) and cleanliness of linen ( @ % ) , followed by the general indoor appearance room in which patient stayed , lack of noise ( @-@ % ) , hospital meals , furniture ( @-@ % ) , availability of personal hygienic articles ( @-@ % ) , cleanliness of hospital room , toilet , showers and bathtubs , and availability of soap ( @-@ % ) .


Choice of provider : Only @ % of patients declared that they had influence on choice of the hospital .


Responsiveness of Polish hospital patient needs is similar to that of the OECD countries of the lowest health system responsiveness .


Compared to the Central European countries , the responsiveness in Polish hospitals is lower than that of Czech Republic and only slightly higher of those of Slovenia , Slovakia and Hungary .


Juvenile idiopathic arthritis ( JIA ) is the most common rheumatic disease in children .


Children with JIA are at risk of inflammation of the uvea in the eye ( uveitis ) .


Overall , @ % to @ % of paediatric uveitis is associated with JIA .


Major risk factors for development of uveitis in JIA are oligoarticular pattern of arthritis , an age at onset of arthritis of less than seven years of age , and antinuclear antibody positivity .


In the initial stages of mild to moderate inflammation the uveitis is asymptomatic .


This has led to current practice of screening all children with JIA for uveitis .


Approximately @ % to @ % of patients with JIA develop uveitis in seven years following onset of arthritis .


In @ % to @ % of children with JIA-associated uveitis structural complications are present at diagnosis .


Furthermore about @ % to @ % of those with severe uveitis will eventually develop visual impairment secondary to ocular complications such as cataract and glaucoma .


Defining the severity of inflammation and structural complications in uveitis patients is now possible following Standardised Uveitis Nomenclature ( SUN ) guidelines , and modified to incorporate the consensus of end point and outcome criteria into the design of randomised trials .


Despite current screening and therapeutic options ( pre-biologics ) @ % to @ % of children with JIA-associated uveitis may develop bilateral visual impairment and certified legally blind .


To date , there remains no controlled trial evidence of benefits of biologic therapy .


This study will randomise @ patients aged @ to @ years with active JIA-associated uveitis ( despite methotrexate ( MTX ) treatment for at least @ weeks ) .


All participants will be treated for @ months , with follow up of @ years from randomisation ( continuing on MTX throughout ) .


All participants will receive a stable dose of MTX and in addition either adalimumab ( @ mg/@ @ ml for patients < @ kg or @ mg/@ @ ml for patients weighing @ kg or more , subcutaneous ( s/c ) injection every @ weeks based on body weight ) , or placebo ( @ ml as appropriate according to body weight ) s/c injection every @ weeks .


This is the first randomised controlled trial that will assess the clinical effectiveness , safety and cost effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis .


To estimate the associations between autism spectrum disorder ( ASD ) diagnoses and service use , caregiver time , and cost outcomes .


We used national data from the Medical Expenditure Panel Survey linked to the National Health Interview Survey and a study-specific survey to estimate the annual utilization and costs for health care , school , ASD-related therapy , family-coordinated services , as well as caregiver time in children aged @ to @ years , with and without parent-reported ASD .


Regression analyses estimated the association between ASD diagnosis and cost , controlling for child gender , age , race/ethnicity , insurance status , household income , country region and urban/rural classification , and non-ASD-related illnesses .


Children with parent-reported ASD had higher levels of health care office visits and prescription drug use compared with children without ASD ( P < @ ) .


A greater proportion of children in the ASD group used special educational services ( @ % vs. @ % in the control group , P < @ ) .


After adjusting for child demographic characteristics and non-ASD-associated illnesses , ASD was associated with $ @ ( @ % confidence interval -LSB- CI -RSB- : $ @ - $ @ ) higher health care costs and $ @,@ ( @ % CI : $ @ - $ @,@ ) higher aggregate non-health care costs , including $ @ ( @ % CI : $ @ - $ @,@ ) higher school costs .


In adjusted analyses , parents who reported that their child had ASD did not have significantly higher out-of-pocket costs or spend more time on caregiving activities compared with control parents .


The economic burden associated with ASD is substantial and can be measured across multiple sectors of our society .


Previous analyses that focused on health care underestimated this economic burden , particularly for school systems .


To compare the two different nutritional supports , enteral nutrition and parenteral nutrition in the aspects of nutritional conditions , immune status , the incidence of perioperative complications and quality of life impacts in pancreatic cancer .


For the pancreatic cancer patients which pancreaticoduodenectomy were performed from January @ to December @ in five high-volume medical centres , prospective , randomized controlled study was carried out .


The enrolled patients were randomly divided into enteral nutritional group ( EN group ) and parenteral nutritional group ( PN group ) .


Related indicators , such as nutritional conditions , immune status , incidence of complications , general status and quality of life were assessed .


The @ patients were enrolled , while @ cases which @ patients in EN group and @ patients in PN group were qualified to evaluate .


The @ cases were dropped out .


For the mean hospital stay ( ( @ @ ) days and ( @ @ ) days respcectively ) , Karnofsky score and the life quality scoring , there are no statistical differences between the two groups .


In post-operation day @ and day @ , the prealbumin was ( @ @ ) mg/L and ( @ @ ) mg/L in EN group and it was ( @ @ ) mg/L and ( @ @ ) mg/L in PN group , which are all significantly decreased than preoperational levels ( ( @ @ ) mg/L for enteral group and ( @ @ ) mg/L for parenteral group , t = -@ , -@ , -@ , -@ , all P < @ ) , but there was no statistically significant between the @ groups ( P > @ ) .


Other general indicators such as the albumin , hemoglobin , total bilirubin , blood urea nitrogen , serum creatinine , serum potassium and serum sodium , revealed no statistical differences in the @ groups ( P > @ ) ; The total lymphocytes , CD ( + ) @CD ( + ) @ and CD ( + ) @CD ( + ) @ lymphocytes in PN group was ( @ @ ) @ ( @ ) / L , ( @ @ ) @ ( @ ) / L , and ( @ @ ) @ ( @ ) / L respectively in post-operation day @ , which they are significantly decreased than in preoperational levels of PN group and the respective counterpart of EN group in post-operation day@ ( t = -@ -@ , P < @ ) .


The @ patients were suffered from different complications in the @ groups , but there was no statistical differences among them ( P > @ ) .


Enteral nutritional support could not decrease the incidence of perioperative complications in pancreatic cancer patient , but it can improve the immunonutrition status in comparison with parenteral nutrition .


Clustering of outcomes at centers involved in multicenter trials is a type of center effect .


The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials ( RCTs ) should account for center effects in their analysis , however most do not .


The Early External Cephalic Version ( EECV ) trials published in @ and @ stratified by center at randomization , but did not account for center in the analyses , and due to the nature of the intervention and number of centers , may have been prone to center effects .


Using data from the EECV trials , we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing ( early or delayed ) on the outcomes of cesarean section , preterm birth , and non-cephalic presentation at the time of birth .


The data from the EECV pilot trial and the EECV@ trial were merged into one dataset .


Fisher 's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects .


Seven statistical models that accounted for center effects were applied to the data .


The models included : i ) the Mantel-Haenszel test , ii ) logistic regression with fixed center effect and fixed treatment effect , iii ) center-size weighted and iv ) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction , iv ) logistic regression with random center effect and fixed treatment effect , v ) logistic regression with random center effect and random treatment-by-center interaction , and vi ) generalized estimating equations .


For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial .


The results were similar for the majority of the methods used to adjust for center , illustrating the robustness of the findings .


Despite literature that suggests center effect can change the estimate of effect in multicenter trials , this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect .


Evidence supports peroneal nerve functional electrical stimulation ( FES ) as an effective alternative to ankle-foot orthoses ( AFO ) for treatment of foot drop poststroke , but few randomized controlled comparisons exist .


To compare changes in gait and quality of life ( QoL ) between FES and an AFO in individuals with foot drop poststroke .


In a multicenter randomized controlled trial ( ClinicalTrials.gov #NCT @ ) with unblinded outcome assessments , @ Medicare-eligible individuals at least @ months poststroke wore FES or an AFO for @ months .


Primary endpoints : @-Meter Walk Test ( @MWT ) , a composite of the Mobility , Activities of Daily Living/Instrumental Activities of Daily Living , and Social Participation subscores on the Stroke Impact Scale ( SIS ) , and device-related serious adverse event rate .


Secondary endpoints : @-Minute Walk Test , GaitRite Functional Ambulation Profile ( FAP ) , Modified Emory Functional Ambulation Profile ( mEFAP ) , Berg Balance Scale ( BBS ) , Timed Up and Go , individual SIS domains , and Stroke-Specific Quality of Life measures .


Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority .


A total of @ subjects completed the study .


FES proved noninferior to the AFO for all primary endpoints .


Both the FES and AFO groups improved significantly on the @MWT .


Within the FES group , significant improvements were found for SIS composite score , total mFEAP score , individual Floor and Obstacle course time scores of the mEFAP , FAP , and BBS , but again , no between-group differences were found .


Use of FES is equivalent to the AFO .


Further studies should examine whether FES enables better performance in tasks involving functional mobility , activities of daily living , and balance .


We evaluated changes in social capital following group-based cognitive processing therapy ( CPT ) for female survivors of sexual violence .


We compared CPT with individual support in a cluster-randomized trial in villages in South Kivu province , Democratic Republic of the Congo .


Local psychosocial assistants delivered the interventions from April through July @ .


We evaluated differences between CPT and individual support conditions for structural social capital ( i.e. , time spent with nonkin social network , group membership and participation , and the size of financial and instrumental support networks ) and emotional support seeking .


We analyzed intervention effects with longitudinal random effects models .


We obtained small to medium effect size differences for @ study outcomes .


Women in the CPT villages increased group membership and participation at @-month follow-up and emotional support seeking after the intervention compared with women in the individual support villages .


Results support the efficacy of group CPT to increase dimensions of social capital among survivors of sexual violence in a low-income conflict-affected context .


Gut microbiota provides beneficial effects under physiological conditions , but is able to contribute to inflammatory diseases in susceptible individuals .


Thus , we designed this study to test whether additional intake of symbiotic gel affects specific modifications of gut microbiota in patients with end-stage renal disease ( ESRD ) .


Eighteen patients with ESRD diagnosis with renal replacement therapy ( hemodialysis ) were included in this study .


They were randomly assigned to @ treatment groups : ( @ ) test group ( nutritional counseling + symbiotic ) and ( @ ) control group ( nutritional counseling + placebo ) .


Clinical history and the evaluation of Gastrointestinal Symptom Rating Scale were performed .


Gut microbiota composition was analyzed by real-time polymerase chain reaction from fecal samples .


All subjects were followed for @months .


Bifidobacterial counts were higher in the second samples ( mean : @ log@ cells/g ) than in first samples ( @ log @cells/g ) in the patients of the test group ( P = @ ) .


Also , lactobacilli counts had a little decrease in the test group ( @ to @ log @ cells/g ) and the control group ( @ to @ log @ cells/g ) , between the first and the second samples .


Gastrointestinal symptoms scores ( scale @-@ ) were reduced in the test group ( start @ -LSB- @-@ -RSB- and end @ -LSB- @-@ -RSB- ) compared with control group ( start @ -LSB- @-@ -RSB- and end @ -LSB- @-@ -RSB- ) .


Short-term symbiotic treatment in patients with ESRD can lead to the increase of Bifidobacterium counts , maintaining the intestinal microbial balance .


A longitudinal integration approach evaluated all radiographic scores assessed over @ years , rather than only completer data , from @ studies of adalimumab ( ADA ) for rheumatoid arthritis ( RA ) .


The DE@ ( methotrexate -LSB- MTX -RSB- - inadequate responders , longstanding RA ) and PREMIER ( MTX-naive , early RA ) studies , respectively , had @ - or @-year double-blind periods followed by @ - or @-year open-label extensions ( OLEs ) .


Patients received ADA MTX in both OLEs .


Radiographic progression was assessed using change from baseline in modified total Sharp score ( mTSS ) .


A mixed-effects model was used post hoc to evaluate repeated measurements of different data campaigns and to estimate mTSS through up to @ years of treatment based on original randomization groups ( placebo -LSB- PBO -RSB- + MTX or standard dose ADA + MTX ) .


Data from patients with baseline and @ postbaseline radiograph were included ( n = @ for DE@ ; n = @ for PREMIER ) .


Integrated and @-year completer mTSS progression curves differed slightly .


In DE@ , for patients originally assigned PBO + MTX , accrued mTSS at year @ was @ units ( integrated model ) and @ units ( completers ) .


For patients originally assigned ADA + MTX , accrued mTSS was @ units by integrated analysis and @ units in completers .


In PREMIER , for patients originally assigned PBO + MTX , accrued mTSS at year @ was @ units ( integrated analysis ) and @ units ( completers ) .


For patients originally assigned ADA + MTX , accrued mTSS was @ units ( integrated analysis ) and @ units ( completers ) .


A higher radiographic progression rate was observed in patients who received delayed versus immediate ADA + MTX treatment .


Longitudinal integrated analysis provided robust estimates of radiographic progression that only slightly differed from completers-only scores and confirmed the effects .


We aimed to investigate the clinical significance of the activation of Yes-Associated Protein @ ( YAP@ ) , a key downstream effector of Hippo tumor-suppressor pathway , in ovarian cancer .


A gene expression signature reflecting activation of YAP@ was developed from gene expression data of @ samples from patients with ovarian cancer .


A refined ovarian cancer YAP@ signature was validated in an independent ovarian cancer cohort ( n = @ ) .


Associations between the YAP@ signature and prognosis were assessed using Kaplan-Meier plots , the log-rank test , and a Cox proportional hazards model .


We identified a @-gene expression signature reflecting YAP@ activation in ovarian cancer .


In multivariate analysis , the signature was an independent predictor of overall survival ( hazard ratio = @ ; @ % confidence interval = @ to @ ; p = @ ) .


In subset analysis , the signature identified patients likely to benefit from taxane-based adjuvant chemotherapy .


Activation of YAP@ is significantly associated with prognosis and the YAP@ signature can predict response to taxane-based adjuvant chemotherapy in patients with ovarian cancer .


Epidemiology associates whole-grain ( WG ) consumption with several health benefits .


Mounting evidence suggests that WG wheat polyphenols play a role in mechanisms underlying health benefits .


The objective was to assess circulating concentration , excretion , and the physiologic role of WG wheat polyphenols in subjects with suboptimal dietary and lifestyle behaviors .


A placebo-controlled , parallel-group randomized trial with @ healthy overweight/obese subjects with low intake of fruit and vegetables and sedentary lifestyle was performed .


Participants replaced precise portions of refined wheat ( RW ) with a fixed amount of selected WG wheat or RW products for @ wk .


At baseline and every @ wk , blood , urine , feces , and anthropometric and body composition measures were collected .


Profiles of phenolic acids in biological samples , plasma markers of metabolic disease and inflammation , and fecal microbiota composition were assessed .


WG consumption for @-@ wk determined a @-fold increase in serum dihydroferulic acid ( DHFA ) and a @-fold increase in fecal ferulic acid ( FA ) compared with RW consumption ( no changes ) .


Similarly , urinary FA at @ wk doubled the baseline concentration only in WG subjects .


Concomitant reduction in plasma tumor necrosis factor - ( TNF - ) after @ wk and increased interleukin ( IL ) -@ only after @ wk with WG compared with RW ( P = @ ) were observed .


No significant change in plasma metabolic disease markers over the study period was observed , but a trend toward lower plasma plasminogen activator inhibitor @ with higher excretion of FA and DHFA in the WG group was found .


Fecal FA was associated with baseline low Bifidobacteriales and Bacteroidetes abundances , whereas after WG consumption , it correlated with increased Bacteroidetes and Firmicutes but reduced Clostridium .


TNF - reduction correlated with increased Bacteroides and Lactobacillus .


No effect of dietary interventions on anthropometric measurements and body composition was found .


WG wheat consumption significantly increased excreted FA and circulating DHFA .


Bacterial communities influenced fecal FA and were modified by WG wheat consumption .


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


Diarrhoea and respiratory infections are the two biggest causes of child death globally .


Handwashing with soap could substantially reduce diarrhoea and respiratory infections , but prevalence of adequate handwashing is low .


We tested whether a scalable village-level intervention based on emotional drivers of behaviour , rather than knowledge , could improve handwashing behaviour in rural India .


The study was done in Chittoor district in southern Andhra Pradesh , India , between May @ , @ , and Sept @ , @ .


Eligible villages had a population of @-@ people , a state-run primary school for children aged @-@ years , and a preschool for children younger than @ years .


@ villages ( clusters ) were selected , stratified by population size ( < @ vs > @ ) , and randomly assigned in a @:@ ratio to intervention or control ( no intervention ) .


Clusters were enrolled by the study manager .


Random allocation was done by the study statistician using a random number generator .


The intervention included community and school-based events incorporating an animated film , skits , and public pledging ceremonies .


Outcomes were measured by direct observation in @-@ households per village at baseline and at three follow-up visits ( @ weeks , @ months , and @ months after the intervention ) .


Observers had no connection with the intervention and observers and participant households were told that the study was about domestic water use to reduce the risk of bias .


No other masking was possible .


The primary outcome was the proportion of handwashing with soap at key events ( after defecation , after cleaning a child 's bottom , before food preparation , and before eating ) at all follow-up visits .


The control villages received a shortened version of the intervention before the final follow-up round .


Outcome data are presented as village-level means .


Handwashing with soap at key events was rare at baseline in both the intervention and control groups ( @ % -LSB- SD @ -RSB- vs @ % -LSB- @ -RSB- ) .


At @ weeks ' follow-up , handwashing with soap at key events was more common in the intervention group than in the control group ( @ % -LSB- SD @ -RSB- vs @ % -LSB- @ -RSB- ; difference @ % , p = @ ) .


At the @-month follow-up visit , the proportion handwashing with soap was @ % ( SD @ ) in the intervention group versus @ % ( @ ) in the control group ( difference @ % ; p = @ ) .


At the @-month follow-up visit , after the control villages had received the shortened intervention , the proportion handwashing with soap was @ % ( SD @ ) in the intervention group and @ % ( @ ) in the control group .


This study shows that substantial increases in handwashing with soap can be achieved using a scalable intervention based on emotional drivers .


A prospective , randomized , and double-blind study .


To compare the efficacy of ramosetron and palonosetron on preventing postoperative nausea and vomiting ( PONV ) associated with opioid-based intravenous patient-controlled analgesia ( IV-PCAopioid ) after lumbar spinal surgery .


IV-PCAopioid , an effective method to control pain after lumbar spinal surgery , accompanies PONV .


Ramosetron and palonosetron are novel @-hydroxytryptamine @ antagonists known to have longer action duration and higher receptor affinity than their congeners , whereas their relative efficacy has not been validated yet .


One hundred ninety-six patients were randomly and evenly allocated to receive either @ mg of ramosetron or @ mg of palonosetron @ minutes before the end of operation .


Ramosetron or palonosetron were also added to the IV-PCAopioid , which was continuously infused for @ hours postoperatively .


The incidence and intensity of PONV were serially assessed for @ hours postoperatively .


Intensity of pain , volume of IV-PCAopioid consumption , use of rescue analgesics and antiemetics , and adverse events were also assessed .


The overall incidence of PONV was lower in the ramosetron group than the palonosetron group ( @ % vs. @ % , P = @ ) without any intergroup difference in the incidence of vomiting .


Nausea intensity scores were also lower until @ ( P = @ ) and @ hour ( P = @ ) postoperatively in the ramosetron group than the palonosetron group .


Pain intensity scores were significantly lower in the ramosetron group than the palonosetron group for @ hours postoperatively .


Ramosetron was superior to palonosetron in term of reducing the incidence and severity of nausea associated with IV-PCAopioid after lumbar spinal surgery .


This favorable influence of ramosetron on PONV was translated to significant postoperative pain reduction compared with palonosetron .


For patients with limited prognosis , some medication risks may outweigh the benefits , particularly when benefits take years to accrue ; statins are one example .


Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy .


To evaluate the safety , clinical , and cost impact of discontinuing statin medications for patients in the palliative care setting .


This was a multicenter , parallel-group , unblinded , pragmatic clinical trial .


Eligibility included adults with an estimated life expectancy of between @ month and @ year , statin therapy for @ months or more for primary or secondary prevention of cardiovascular disease , recent deterioration in functional status , and no recent active cardiovascular disease .


Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to @ year .


The study was conducted from June @ , @ , to May @ , @ .


All analyses were performed using an intent-to-treat approach .


Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group .


Patients in the continuation group continued to receive statins .


Outcomes included death within @ days ( primary outcome ) , survival , cardiovascular events , performance status , quality of life ( QOL ) , symptoms , number of nonstatin medications , and cost savings .


A total of @ patients were enrolled ; @ of these were randomized to discontinue statins , and @ were randomized to continue therapy .


Mean ( SD ) age was @ ( @ ) years , @ % of the participants were cognitively impaired , and @ % had cancer .


The proportion of participants in the discontinuation vs continuation groups who died within @ days was not significantly different ( @ % vs @ % ; @ % CI , -@ % to @ % ; P = @ ) and did not meet the noninferiority end point .


Total QOL was better for the group discontinuing statin therapy ( mean McGill QOL score , @ vs @ ; P = @ ) .


Few participants experienced cardiovascular events ( @ in the discontinuation group vs @ in the continuation group ) .


Mean cost savings were $ @ per day and $ @ per patient .


This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL , use of fewer nonstatin medications , and a corresponding reduction in medication costs .


Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted .


Several studies have shown that unnecessary right ventricular pacing has detrimental effects .


To evaluate whether minimization of ventricular pacing as compared with standard dual-chamber pacing ( DDD ) improves clinical outcomes in patients referred for pacemaker or implantable cardioverter-defibrillator ( ICD ) replacement .


In an international single-blind , multicenter , randomized controlled trial , we compared DDD with managed ventricular pacing ( MVP ) , a pacing mode developed to minimize ventricular pacing by promoting intrinsic atrioventricular conduction .


We included patients referred for device replacement with > @ % ventricular pacing , no cardiac resynchronization therapy upgrade indication , no permanent atrial fibrillation ( AF ) , and no permanent complete atrioventricular block .


Follow-up was for @ years .


The primary end point was cardiovascular hospitalization .


The intention-to-treat analysis was performed by using Kaplan-Meier method and the log-rank test .


We randomized @ patients ( @ referred for pacemaker and @ referred for ICD replacement ; mean age @ @ years ; @ -LSB- @ % -RSB- men , at @ @ years from first device implantation ) to MVP ( n = @ ) or DDD ( n = @ ) .


We found no significant differences in the primary end point cardiovascular hospitalization ( MVP : @ % vs DDD : @ % ; P = @ ) and the secondary end point persistent AF ( MVP : @ % vs DDD : @ % ; P = @ ) , permanent AF ( MVP : @ % vs DDD : @ % ; P = @ ) , and composite of death and cardiovascular hospitalization ( MVP : @ % vs DDD : @ % ; P = @ ) .


MVP reduced right ventricular pacing ( median @ % vs @ % ; Wilcoxon , P < @ ) as compared with DDD .


In patients referred for pacemaker and ICD replacement with clinically well-tolerated long-term exposure to > @ % ventricular pacing in the ventricle , a strategy to minimize ventricular pacing is not superior to standard DDD in reducing incidence of cardiovascular hospitalizations .


To compare gadobenate dimeglumine-enhanced magnetic resonance imaging ( MRI ) with gadopentetate dimeglumine-enhanced MRI , mammography , and ultrasound for breast cancer detection across different malignant lesion types and across different densities of breast tissue .


In all , @ women with Breast Imaging Reporting and Data System ( BI-RADS ) @ findings on mammography and/or ultrasound underwent identical breast MRI exams at @ T with gadobenate dimeglumine and gadopentetate dimeglumine .


Images were evaluated by three independent blinded radiologists .


Mammography , ultrasound , and combined mammography and/or ultrasound findings were available for @ , @ , and @ women .


Imaging findings were matched with histology data by a fourth , independent , blinded radiologist .


Malignant lesion detection rates and diagnostic performance were compared .


In all , @ , @ , and @ confirmed malignant lesions were present in patients undergoing MRI + mammography , MRI + ultrasound , and MRI + mammography and/or ultrasound , respectively .


Significantly greater cancer detection rates were noted by all three readers for comparisons of gadobenate dimeglumine-enhanced MRI with mammography ( @ % ; P < @ ) , ultrasound ( @ % ; P < @ ) , and mammography and/or ultrasound ( @ % ; P @ ) but not for comparisons of gadopentetate dimeglumine-enhanced MRI with conventional techniques ( P > @ ) .


The false-positive detection rates were lower on gadobenate dimeglumine-enhanced MRI than on conventional imaging ( @ % vs. @ % at mammography ; @ % vs. @ % at ultrasound ) .


Significantly improved cancer detection on MRI was noted in heterogeneously dense breast ( @ % on gadobenate dimeglumine-enhanced MRI vs. @ % on gadopentetate dimeglumine-enhanced MRI vs. @-@ @ % with conventional techniques ) and for invasive cancers ( @ % for invasive ductal carcinoma -LSB- IDC -RSB- on gadobenate dimeglumine-enhanced MRI vs. @ % on gadopentetate dimeglumine-enhanced MRI vs. @ % with conventional techniques ) .


Overall diagnostic performance for the detection of cancer was superior on gadobenate dimeglumine-enhanced MRI than on conventional imaging or gadopentetate dimeglumine-enhanced MRI .


Gadobenate dimeglumine-enhanced MRI significantly improves cancer detection compared to gadopentetate dimeglumine-enhanced MRI , mammography , and ultrasound in a selected group of patients undergoing breast MRI for preoperative staging or because of inconclusive findings at conventional imaging .


To observe the efficacy of combined use of brimonidine and betaxolol in treatment of primary open angle glaucoma ( POAG ) and ocular hypertension .


A total of @ patients ( @ eyes ) with POAG and ocular hypertension were randomly divided into three groups ( receiving betaxolol , brimonidine and combined administration of betaxolol and brimonidine respectively ) .


The administration was given twice daily in all groups ( @ % betaxolol , @ % brimonidine and @ % betaxolol combined with @ % brimonidine ) .


The changes in intraocular pressure ( IOP ) were observed before , and @ , @ , @ , and @ weeks after treatment .


In addition , the adverse reactions were also recorded post-treatment .


The mean IOPs at all the time points after treatment were significantly reduced compared with pre-treatment levels ( P < @ ) .


Patients receiving brimonidine had a greater reduction in IOP compared with their counterparts in the betaxolol group but the difference was not statistically significant .


The IOP decline was significantly higher in the combined therapy group than in the other two groups ( P < @ ) .


Few cases presented with slight discomfort , such as sensation of foreign bodies , ocular irritation , dizziness , headache , fatigue , and dryness of mouth and nose .


No severe adverse reactions were noted following administration .


Combined use of brimonidine and betaxolol is an efficacious treatment of reducing IOP without severe side effects .


Calcium aluminosilicate clay ( CASAD ) is a naturally occurring clay that serves as a cation exchange absorbent .


We hypothesized that oral administration of CASAD would reduce the rate of grade @/@ diarrhea associated with irinotecan use for metastatic colorectal cancer ( CRC ) by adsorbing the SN-@ metabolite .


Patients receiving irinotecan-based chemotherapy were randomized equally between CASAD and placebo arms in this multicenter trial in order to assess differences in the proportions of patients with grade @/@ diarrhea within @ weeks .


Additionally , we compared symptom severity between the two arms using the M.D. Anderson Symptom Inventory .


Between May @ and May @ , @ patients were enrolled .


In evaluable patients , @ of @ ( @ % ) on the CASAD arm compared to @ of @ ( @ % ) on the placebo arm experienced grade @/@ diarrhea ( P = @ ) .


The rate of any diarrhea among all patients was similar ( CASAD arm , @ % vs. placebo arm , @ % ) .


The rate of study dropout was @ % in the CASAD arm and @ % in the placebo arm ( P = @ ) .


No differences were found in symptom severity , individual symptom items , and in serious adverse events between the two arms .


Compared to placebo , CASAD use was safe but ineffective in preventing diarrhea in metastatic CRC patients treated with irinotecan-containing chemotherapy regimens .


There were no distinct signals in terms of patient symptoms between arms , but there was significantly more patient dropout in the placebo arm .


Future CASAD trials will focus on the active treatment of diarrhea .


Pulmonary hypertension ( PH ) associated with fibrotic idiopathic interstitial pneumonia ( IIP ; idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia ) confers important additional morbidity and mortality .


To evaluate the safety and clinical efficacy of the dual endothelin-@ receptor antagonist bosentan in this patient group .


In a randomized , double-blind , placebo-controlled study , @ patients with fibrotic IIP and right heart catheter confirmed PH were randomized @:@ to bosentan ( n = @ ) or placebo ( n = @ ) .


The primary study endpoint was a fall from baseline pulmonary vascular resistance index ( PVRi ) of @ % or more over @ weeks .


Sixty patients ( @ men ; mean age , @ @ yr ) , with a mean pulmonary artery pressure of @ ( @ ) mm Hg , PVRi @ ( @ ) Wood Units/m ( @ ) and reduced cardiac index of @ ( @ ) L/min/m ( @ ) were recruited to the study .


Accounting for deaths and withdrawals , paired right heart catheter data were available for analysis in @ patients ( bosentan = @ , placebo = @ ) .


No difference in the primary outcome was detected , with seven ( @ % ) patients receiving bosentan , and four ( @ % ) receiving placebo achieving a reduction in PVRi of greater than or equal to @ % ( P = @ ) at @ weeks .


There was no change in functional capacity or symptoms between the two groups at @ weeks , nor any difference in rates of serious adverse events or deaths ( three deaths in each group ) .


This study shows no difference in invasive pulmonary hemodynamics , functional capacity , or symptoms between the bosentan and placebo groups over @ weeks .


Our data do not support the use of the dual endothelin-@ receptor antagonist , bosentan , in patients with PH and fibrotic IIP .


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


The integrase inhibitor dolutegravir and nucleoside analogues abacavir and lamivudine are once-daily treatment options for HIV .


This study ( NCT@ ) evaluated , first , the bioequivalence ( BE ) of a fixed-dose combination ( FDC ) tablet containing dolutegravir @ mg , abacavir @ mg , and lamivudine @ mg ( dolutegravir/abacavir/lamivudine FDC ) vs coadministered dolutegravir @ mg and abacavir/lamivudine combination tablets ( Epzicom ) and , second , the effect of food on the dolutegravir/abacavir/lamivudine FDC tablet .


Study part A ( @ healthy subjects ) was a single-dose , open-label , randomized , @-period crossover study to evaluate the BE of the dolutegravir/abacavir/lamivudine FDC tablet and dolutegravir + abacavir/lamivudine tablets in the fasted state .


In study part B , @ subjects from part A received the dolutegravir/abacavir/lamivudine FDC tablet with a high-fat meal .


BE and food effect were assessed by analysis of variance to determine the ratio of geometric least squares means and associated @ % confidence intervals for key pharmacokinetic parameters for each of dolutegravir , abacavir , and lamivudine .


Sixty-two subjects completed part A.


The dolutegravir/abacavir/lamivudine tablet was bioequivalent to the dolutegravir + abacavir/lamivudine tablets ; @ % confidence intervals for the geometric least squares mean ratios fell within the @-@ @ BE criteria .


The effect of food on the dolutegravir/abacavir/lamivudine FDC tablet was similar to previous food effects observed with the separate formulations .


The safety profile was comparable between treatments , with no observed serious or grade @/@ adverse events .


The BE of the dolutegravir/abacavir/lamivudine FDC tablet was demonstrated ; it may be administered without regard to meals .


Crohn 's disease ( CD ) usually recurs after intestinal resection ; postoperative endoscopic monitoring and tailored treatment can reduce the chance of recurrence .


We investigated whether monitoring levels of fecal calprotectin ( FC ) can substitute for endoscopic analysis of the mucosa .


We analyzed data collected from @ participants in a prospective , randomized , controlled trial , performed at @ hospitals in Australia and @ hospital in New Zealand , that assessed the ability of endoscopic evaluations and step-up treatment to prevent CD recurrence after surgery .


Levels of FC , serum levels of C-reactive protein ( CRP ) , and Crohn 's disease activity index ( CDAI ) scores were measured before surgery and then at @ , @ , and @ months after resection of all macroscopic Crohn 's disease .


Ileocolonoscopies were performed at @ months after surgery in @ patients and at @ months after surgery in all patients .


Levels of FC were measured in @ samples from @ patients .


The median FC level decreased from @ g/g before surgery to @ g/g at @ months after surgery , but was higher in patients with disease recurrence ( based on endoscopic analysis ; Rutgeerts score , i@ ) than in patients in remission ( @ vs @ g/g , respectively ; P < @ ) .


Combined @ - and @-month levels of FC correlated with the presence ( r = @ ; P < @ ) and severity ( r = @ ; P < @ ) of CD recurrence , but the CRP level and CDAI score did not .


Levels of FC greater than @ g/g indicated endoscopic recurrence with @ % sensitivity and @ % specificity , and a negative predictive value ( NPV ) of @ % ; this means that colonoscopy could have been avoided in @ % of patients .


Six months after surgery , FC levels less than @ g/g in patients in endoscopic remission predicted maintenance of remission ( NPV , @ % ) .


In patients with endoscopic recurrence at @ months who stepped-up treatment , FC levels decreased from @ g/g at @ months to @ g/g at @ months and @ g/g at @ months .


In this analysis of data from a prospective clinical trial , FC measurement has sufficient sensitivity and NPV values to monitor for CD recurrence after intestinal resection .


Its predictive value might be used to identify patients most likely to relapse .


After treatment for recurrence , the FC level can be used to monitor response to treatment .


It predicts which patients will have disease recurrence with greater accuracy than CRP level or CDAI score .


Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia .


Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol , which should include score interpretation and verification with appropriately suggested treatments .


The Observational Pain Management Protocol ( Protocol ) was therefore developed .


This study aims to investigate the extent to which the implementation of this Protocol can improve pain management in care home residents with dementia .


In this two-group , single-blinded , cluster-randomized controlled trial , @ care home residents with dementia and pain-related diagnoses will be recruited from eight care homes ( that is @ to @ residents from each care home ) .


Invitations will be sent to all local care homes who meet the home selection criteria .


The eight care homes will be randomly selected from all care homes that agree to join this trial .


They will then be randomized to either the control or experimental conditions .


Participants from each care home will be placed into their home 's corresponding group to avoid ` contamination ' effects across participants .


Each intervention cycle will take @ weeks ( that is , baseline assessment and care home staff training for @ weeks and Protocol implementation for @ weeks ) .


The Protocol will guide the pain management of the participants in the experimental care homes .


Meanwhile , the control care homes will continue their usual pain management strategies .


Intervention effects will be measured weekly during the protocol implementation period and compared with the baseline measurements , as well as between the experimental and control conditions .


Although similar pain protocols have been suggested previously , the recommendations were based on experts ' opinions rather than evaluation of research studies .


The feasibility and effectiveness of this kind of pain management protocol , tailored to older people with dementia , remains unknown .


The findings of this trial will offer strong evidence that better strategies for pain management should be used in the care home daily routine .


Dietary protein digestion and absorption is an important factor modulating muscle protein accretion .


However , there are few data available on the effects of coingesting other macronutrients with protein on digestion and absorption kinetics and the subsequent muscle protein synthetic response .


The objective of the study was to determine the impact of carbohydrate coingestion with protein on dietary protein digestion and absorption and muscle protein accretion in healthy young and older men .


Twenty-four healthy young ( aged @ @ y , body mass index @ @ kg/m ( @ ) ) and @ older ( aged @ @ y , body mass index @ @ kg/m ( @ ) ) men received a primed continuous L - -LSB- ring - ( @ ) H@ -RSB- - phenylalanine and L - -LSB- ring-@ ,@ - ( @ ) H@ -RSB- - tyrosine infusion and ingested @ g intrinsically L - -LSB- @ - ( @ ) C -RSB- - phenylalanine-labeled protein with ( Pro + CHO ) or without ( Pro ) @ g carbohydrate .


Plasma samples and muscle biopsies were collected in a postabsorptive and postprandial state .


Carbohydrate coingestion delayed the appearance of exogenous phenylalanine in the circulation ( P = @ ) .


Dietary protein-derived phenylalanine availability over the @-hour postprandial period was lower in the older ( @ @ % ) when compared with the young subjects ( @ @ % ; P = @ ) , with no differences between conditions ( P = @ ) .


Carbohydrate coingestion did not modulate postprandial muscle protein synthesis rates ( @ @ vs @ @ and @ @ vs @ @ % / h after Pro vs Pro + CHO in the young and older group , respectively ) .


In accordance , no differences in muscle protein-bound L - -LSB- @ - ( @ ) C -RSB- - phenylalanine enrichments were observed between conditions ( @ @ vs @ @ and @ @ vs @ @ mole percent excess after Pro vs Pro + CHO in the young and older subjects , respectively ) .


Carbohydrate coingestion with protein delays dietary protein digestion and absorption but does not modulate postprandial muscle protein accretion in healthy young or older men .


Intrusive thoughts and images are common across the adult lifespan , but vary in their consequences .


Understanding age-related experiences with intrusive thoughts is important for identifying risk and protective factors for intrusive thought problems across the adult lifespan .


This study characterized age trajectories for six aspects of experiences with intrusive thoughts using Internet data collection .


Participants ( N = @ ; ages @-@ ) were randomly assigned to suppress ( i.e. keep out of mind ) or monitor an intrusive thought for one minute , and then later to monitor the thought for a second minute .


Participants tracked thought recurrences during each thinking period , then reported their positive and negative affects following each thinking period , as well as their effort expended in suppressing the thought and perceived difficulty controlling the intrusive thought .


Multilevel modeling and generalized estimating equations modeled the continuous relationships between age and each dependent variable .


As expected , older age was associated with less decline in positive affect while engaging with an intrusive thought .


Interestingly , older age was also associated with a sharper rise and fall of negative affect .


Suppression effort increased linearly with age ( though perceived difficulty did not ) .


Finally , no age differences were found in either the frequency or duration of the thought 's recurrence , adding to previous evidence that older adults function similarly to younger adults in their control of intrusive thoughts , despite certain age-related declines in cognitive functioning .


These findings suggest a dissociation between age-related changes in emotional versus cognitive characteristics of engaging with intrusive thoughts .


Screening to prevent sudden cardiac death remains a contentious topic in sport and exercise medicine .


The aim of this study was to assess whether the use of a standardised criteria tool improves the accuracy of ECG interpretation by physicians screening athletes .


Design : Randomised control trial .


Study Population : General practitioners with an interest in sports medicine , sports physicians , sports medicine registrars and cardiologists from Australia and New Zealand were eligible to participate .


Outcome Measures : Accuracy , sensitivity , specificity and false-positive rates of screening ECG interpretation of athletes .


Intervention : A two-page standardised ECG criteria tool was provided to intervention participants .


Control participants undertook ` usual ' interpretation .


@ physicians , with a mean duration of practice of @years , were randomised to intervention and control .


@ baseline and @ postrandomisation athlete ECGs were interpreted by the participants .


Intervention participants were more likely to be correct : OR @ ( @ % CI @ to @ , p < @ ) .


Correct ECG interpretation was higher in the intervention group , @ % ( @ % CI @ % to @ % ) , than in the control group , @ % ( @ % CI @ % to @ % ; p = @ ) .


Sensitivity was @ % in the intervention group and @ % in the control group ( p = @ ) , with specificity of @ % and @ % , respectively ( p = @ ) .


There were @ % fewer false positives in the intervention group ( p = @ ) .


ECG interpretation in athletes can be improved by using a standardised ECG criteria tool .


Use of the tool results in lower false-positive rates ; this may have implications for screening recommendations .


Anterior knee pain is a major cause of complaint in total knee arthroplasty ( TKA ) without patellar resurfacing .


The concept of improved patellar tracking and decreased retropatellar contact pressure for lateral retinacular release theoretically suggests that patients with lateral retinacular release in TKA would achieve a lower incidence of anterior knee pain when compared without lateral retinacular release .


We sought to determine ( @ ) whether those patients who received a routine lateral retinacular release in TKA would attain lower incidence of anterior knee pain as compared to patients who received TKA without lateral retinacular release and ( @ ) whether lateral retinacular release would increase the lateral retinacular release-related complications .


A total of @ patients who underwent TKA with the use of the Gemini MK II mobile bearing were randomized to receive either routine lateral retinacular release ( intervention group ) or not ( control group ) .


Patients were assessed by the visual analogue scale for anterior knee pain , the Knee Society clinical scoring system of knee score and function score , and patellar score for clinical function .


Patients ' satisfaction and lateral retinacular release-related complications were also evaluated .


The overall incidence of anterior knee pain in the intervention group at @ months follow-up was @ % , while that of the control group was @ % ( p = @ ) .


No statistical difference was detected between the two groups in terms of lateral retinacular release-related complications ( n.s. ) , patients ' satisfaction ( n.s. ) , knee score ( n.s. ) , function score ( n.s. ) , and patellar score ( n.s. ) at @ months follow-up .


The present study suggests that routine lateral retinacular release can reduce anterior knee pain and does not increase lateral retinacular release-related complications , in TKA with the use of the Gemini MK II mobile bearing without patellar resurfacing .


Therapeutic , Level I.


This study was undertaken to investigate whether a gradual reduction of the valve setting ( opening pressure ) decreases the complication rate in patients with idiopathic normal-pressure hydrocephalus ( iNPH ) treated with a ventriculoperitoneal ( VP ) shunt .


In this prospective double-blinded , randomized , controlled , dual-center study , a VP shunt with an adjustable valve was implanted in @ patients with iNPH , randomized into two groups .


In one group ( the @-@ group ) the valve setting was initially set to @ cm HO and gradually reduced to @ cm H@O over the course of the @-month study period .


In the other group ( the @ group ) , the valve was kept at a medium pressure setting of @ cm HO during the whole study period .


The time to and type of complications ( hematoma , infection , and mechanical problems ) as well as overdrainage symptoms were recorded .


Symptoms , signs , and outcome were assessed by means of the iNPH scale and the NPH grading scale .


Six patients in the @-@ group ( @ % ) and @ patients in the @ group ( @ % ) experienced a shunt complication ; @ had subdural hematomas , @ mechanical obstructions , and @ infection ( no significant difference between groups ) .


The frequency of overdrainage symptoms was significantly higher for a valve setting @ cm HO compared with a setting > @ cm HO .


The @-@ group had a higher improvement rate ( @ % ) than the @ group ( @ % ) ( p = @ ) .


There was no significant relationship between complications and body mass index , the use of an antisiphon device , or the use of anticoagulants .


Gradual lowering of the valve setting to a mean of @ cm HO led to the same rate of shunt complications and overdrainage symptoms as a fixed valve setting at a mean of @ cm HO but was associated with a significantly better outcome .


The combination of direct-acting antiviral agents in patients with chronic hepatitis C virus ( HCV ) infection has demonstrated clinical benefit ; however , evaluation of potential drug-drug interactions is required prior to therapy .


An open-label study assessed the pharmacokinetics and tolerability of the HCV NS@A replication complex inhibitor daclatasvir and the HCV NS@ protease inhibitor asunaprevir when co-administered in healthy subjects .


Daclatasvir @mg once daily and asunaprevir @mg twice daily were dosed for @days alone followed by combination dosing for @days at @mg once daily and @mg twice daily , respectively .


Further assessments were provided comparing exposures from the current study with those from studies in HCV-infected patients receiving either the same or higher doses of daclatasvir or asunaprevir administered alone or together .


Dose-normalized daclatasvir and asunaprevir morning exposures were comparable with control in healthy subjects , with geometric mean area under the concentration-time curve ratios of @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) , respectively .


In HCV patients daclatasvir and asunaprevir exposures were largely comparable , when administered together or alone .


Additional data support the conclusion that there is no clinically meaningful interaction between daclatasvir and asunaprevir in either healthy subjects or HCV-infected patients , including those also receiving peginterferon - / ribavirin , and that the combination of daclatasvir @mg once daily and asunaprevir @mg twice daily is generally well-tolerated .


Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety .


However , unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills .


s To investigate whether a detailed consent form explaining the key elements of informed consent , in comparison to a standard consent form , would increase the comprehension and satisfaction of adult cancer patients .


Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer ( protocol @ ( N-SAS/BC -@ ) ) were randomly selected to receive one of the following four versions : detailed document with graphics , detailed document without graphics , standard document with graphics , and standard document without graphics .


The forms were written in plain language from the patients ' point of view .


A total of @ patients were administered questionnaires via interview to assess levels of comprehension , satisfaction , and anxiety .


Patients demonstrated a strong understanding of information regarding treatment and research .


Patient comprehension did not differ significantly between the detailed document arms and the standard document arms .


Patient satisfaction level increased according to the amount of information presented in the consent form ; most patients preferred the detailed document with graphics .


Anxiety and accrual rates in the parent study were not affected by informed consent procedures .


Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy .


Informed consent can be a significant experience for a population with standard literacy skills , as long as the document is easily comprehensible .


Such information should be provided in a format that corresponds with patient needs , education levels , and preferences .


Providing additional Saturday rehabilitation can improve functional independence and health related quality of life at discharge and it may reduce patient length of stay , yet the economic implications are not known .


The aim of this study was to determine from a health service perspective if the provision of rehabilitation to inpatients on a Saturday in addition to Monday to Friday was cost effective compared to Monday to Friday rehabilitation alone .


Cost utility and cost effectiveness analyses were undertaken alongside a multi-center , single-blind randomized controlled trial with a @-day follow up after discharge .


Participants were adults admitted for inpatient rehabilitation in two publicly funded metropolitan rehabilitation facilities .


The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus an additional rehabilitation service on Saturday .


Incremental cost utility ratio was reported as cost per quality adjusted life year ( QALY ) gained and an incremental cost effectiveness ratio ( ICER ) was reported as cost for a minimal clinically important difference ( MCID ) in functional independence .


@ patients ( mean age @ ( standard deviation @ ) years ) were randomly assigned to the intervention ( n = @ ) or the control group ( n = @ ) .


Mean difference in cost of AUD$ @,@ ( @ % confidence interval ( CI ) -@ to @,@ ) was a saving in favor of the intervention group .


The incremental cost utility ratio found a saving of AUD$ @,@ ( @ % CI -@,@ to @,@ ) per QALY gained for the intervention group .


The ICER found a saving of AUD$ @,@ ( @ % CI -@,@ to @,@ ) in achieving a MCID in functional independence for the intervention group .


If the willingness to pay per QALY gained or for a MCID in functional independence was zero dollars the probability of the intervention being cost effective was @ % and @ % , respectively .


A sensitivity analysis removing Saturday penalty rates did not significantly alter the outcome .


From a health service perspective , the provision of rehabilitation to inpatients on a Saturday in addition to Monday to Friday , compared to Monday to Friday rehabilitation alone , is likely to be cost saving per QALY gained and for a MCID in functional independence .


The maximal effect of proton pump inhibitors ( PPI ) is reported to take @ days .


However , most current protocols start PPI on the day of gastric endoscopic submucosal dissection ( ESD ) .


We aimed to evaluate the benefit of @ days pretreatment with oral PPI before ESD to prevent bleeding .


This was a prospective randomized controlled trial .


Patients were administered oral rabeprazole @ mg or placebo twice daily for @ days before ESD .


Intravenous pantoprazole @ mg was administered @ h before ESD and at postprocedure day @ , and then oral rabeprazole @ mg was administered once daily .


Follow-up endoscopy was performed on days @ and @ .


Forty-eight-hour measurement of intragastric pH was performed in @ patients .


The primary endpoint was major bleeding related to ESD .


One-hundred and twenty patients were enrolled .


Of these , @ in the pretreatment and @ in the placebo group were analyzed .


Each group had three cases of major bleeding .


There were no significant differences in the ulcer healing rate .


Intragastric pH percentage times greater than @ , @ , and @ were @ @ % , @ @ % , and @ @ % , respectively , in the pretreatment and @ @ % , @ @ % , and @ @ % , respectively , in the placebo group , without significant differences .


Preprocedural administration of rabeprazole offers no additional benefit over postprocedural administration alone in preventing major bleeding after gastric ESD .


To determine the relationship between type three secretion genotype and fluoroquinolone resistance for P. aeruginosa strains isolated from microbial keratitis during the Steroids for Corneal Ulcers Trial ( SCUT ) and for two laboratory strains , PA@ and PAO@ .


Confirmed P. aeruginosa isolates from the SCUT were divided into exoU ( + ) or exoU ( - ) .


The exoU ( + ) strains contained the gene encoding ExoU , a powerful phospholipase toxin delivered into host cells by the type three secretion system .


Isolates were then assessed for susceptibility to fluoroquinolone , cephalosporin , and aminoglycoside antibiotics using disk diffusion assays .


Etest was used to determine the MIC of moxifloxacin and other fluoroquinolones .


Laboratory isolates in which the exoU gene was added or deleted were also tested .


A significantly higher proportion of exoU ( + ) strains were resistant to ciprofloxacin ( p = @ ) , gatifloxacin ( p = @ ) , and ofloxacin ( p = @ ) compared to exoU ( - ) isolates .


There was no significant difference between exoU ( + ) or exoU ( - ) negative isolates with respect to susceptibility to other antibiotics except gentamicin .


Infections involving resistant exoU ( + ) strains trended towards worse clinical outcome .


Deletion or acquisition of exoU in laboratory isolates did not affect fluoroquinolone susceptibility .


Fluoroquinolone susceptibility of P. aeruginosa isolated from the SCUT is consistent with previous studies showing elevated resistance involving exoU encoding ( cytotoxic ) strains , and suggest worse clinical outcome from infections involving resistant isolates .


Determination of exoU expression in clinical isolates of P. aeruginosa may be helpful in directing clinical management of patients with microbial keratitis .


Few evidence-based interventions address adolescent relationship abuse in clinical settings .


This cluster randomized controlled trial tested the effectiveness of a brief relationship abuse education and counseling intervention in school health centers ( SHCs ) .


In @-@ , @ SHCs ( @ clusters ) were randomized to intervention ( SHC providers received training to implement ) or standard-of-care control condition .


Among @ eligible students ages @ to @ years at @ SHCs who continued participation after randomization , @ completed computer-assisted surveys before a clinic visit ; @ completed surveys @ months later ( @ % retention ) .


Intervention versus control adjusted mean differences ( @ % confidence interval ) on changes in primary outcomes were not statistically significant : recognition of abuse = @ ( -@ to @ ) ; intentions to intervene = @ ( -@ to @ ) ; and knowledge of resources = @ ( -@ to @ ) .


Intervention participants had improved recognition of sexual coercion compared with controls ( adjusted mean difference = @ -LSB- @ to @ -RSB- ) .


In exploratory analyses adjusting for intensity of intervention uptake , intervention effects were significant for increased knowledge of relationship abuse resources and self-efficacy to use harm reduction behaviors .


Among participants reporting relationship abuse at baseline , intervention participants were less likely to report such abuse at follow-up ( mean risk difference = -@ -LSB- -@ to -@ -RSB- ) .


Adolescents in intervention clinics who reported ever being in an unhealthy relationship were more likely to report disclosing this during the SHC visit ( adjusted odds ratio = @ -LSB- @ to @ -RSB- ) .


This is the first evidence of the potential benefit of a SHC intervention to address abusive relationships among adolescents .


To assess bacterial colonization following balloon uterine stent placement in the uterus for @ days .


Prospective randomized controlled study .


Tertiary medical center .


Sixty-eight women scheduled for hysteroscopy .


Women who were undergoing hysteroscopic surgery were randomly assigned to receive a balloon uterine stent or not .


Before starting surgery , the uterine cavity was swabbed for bacterial culture .


The device was placed in the uterus after surgery in the stent group .


After @ days , the stent was removed and sent for culture and the uterine cavity also swabbed and cultured .


The uterine cavities of the control patients were swabbed before and @ days after surgery .


The primary outcome was the incidence of bacterial colonization of the uterus .


Secondary outcomes were pain intensity and species of colonizing bacteria .


Excluding eight women , @ women in each group were included in this analysis .


In the stent group , three women ( @ % ) demonstrated bacterial colonization before surgery compared with nine women ( @ % ) after @ days .


In the control group , four ( @ % ) and ten ( @ % ) women had microorganisms detected in the uterus before and after @ days after surgery , respectively .


In neither group did the percentage of women with uterine microorganisms increase significantly after @ days .


The percentages of women with uterine bacterial colonization before and @ days after surgery were similar between both groups .


Balloon uterine stents may be placed after surgery for up to @ days without increasing bacterial colonization .


RAS mutations predict resistance to anti-epidermal growthfactor receptor ( EGFR ) monoclonal antibodies in metastatic colorectal cancer .


We analysed RAS mutations in @ non-metastatic rectal cancer patients treated with or without cetuximab within the @ EXPERT-C trial .


Ninety of @ patients with tumours available for analysis were KRAS/BRAF wild-type , and randomly assigned to capecitabine plus oxaliplatin ( CAPOX ) followed by chemoradiotherapy , surgery and adjuvant CAPOX or the same regimen plus cetuximab ( CAPOX-C ) .