Astigmatism increased in the PCRI group between the @-month and @-month follow-up ( mean @ @ D ; maximum @ D ) ( P < @ ) .


Toric IOLs and PCRIs both reduced astigmatism ; however , toric IOLs reduced astigmatism to a higher extent and they were more predictable .


To evaluate the long-term efficacy and safety of certolizumab pegol ( CZP ) treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis ( RA ) patients who could not receive methotrexate ( MTX ) .


HIKARI double-blind ( DB ) patients were entered into an open-label extension ( OLE ) study .


Patients withdrawn at @ weeks due to lack of efficacy and DB completers without a @-week American College of Rheumatology ( ACR ) @ response received CZP @ mg every @ weeks ( Q@W ) .


DB completers with @-week ACR@ responses were randomized to CZP @ mg Q@W or CZP @ mg every @ weeks .


The ACR@/ACR@/ACR@ response rates of DB completers ( n = @ ) were @ % / @ % / @ % at OLE entry , and @ % / @ % / @ % at @ weeks , respectively .


Other clinical , functional , and radiographic outcomes were sustained during long-term administration of CZP , even without MTX .


No new unexpected adverse events were observed during long-term CZP treatment .


The efficacy and safety of CZP treatment were similar between the two dosing schedules .


Long-term CZP administration is efficacious and safe for RA patients .


No obvious differences in clinical efficacy and safety were observed between the two dosing schedules .


The choice between two maintenace regimens adds flexibility in administration schedules for RA patients and physicians .


To compare the @-h changes of intraocular pressure ( IOP ) and mean ocular perfusion pressure ( MOPP ) obtained with tafluprost versus travoprost in patients with normal-tension glaucoma ( NTG ) .


This study is a randomized crossover study of @ patients newly diagnosed with NTG who received either tafluprost or travoprost given once at @ PM for @ months , after which they were crossed over to the other medication for another @ months .


IOP and blood pressure were measured for @h before starting the treatment and after finishing the first and second treatment periods .


Forty-one patients completed the study .


The mean ( standard deviation ) @-h IOP was @ mmHg at baseline , @ mmHg on tafluprost , and @ mmHg on travoprost .


Both prostaglandin monotherapies significantly reduced mean @-h IOP as compared with baseline ( P < @ , P < @ , respectively ) , and travoprost demonstrated a lower mean @-h IOP than tafluprost ( P = @ ) .


Both treatments significantly reduced the IOP from baseline at every point over @h .


At @ individual time points , travoprost provided a lower IOP than tafluprost : at @ PM ( @ vs. @ mmHg , P = @ ) , at @ PM ( @ vs. @ mmHg , P = @ ) , and at @ PM ( @ vs. @ mmHg , P = @ ) .


Both tafluprost and travoprost significantly increased the @-h MOPP ( P = @ , P = @ , respectively ) , and travoprost demonstrated a greater @-h MOPP than tafluprost ( P = @ ) .


Both tafluprost and travoprost were effective in lowering IOP and increasing MOPP throughout @h in NTG .


However , travoprost reduced IOP greater than tafluprost in the late afternoon and evening .


Guanidinoacetic acid ( GAA ) is an intermediate in the biosynthesis of creatine ( Cr ) , yet its use in human nutrition is limited due to a lack of a clear understanding of its ' dose-response effect .


Thus , the purpose of this study was to investigate the effect of three different dosages of GAA ( @ , @ and @ g/day ) administered for @ weeks on serum and urinary variables related to GAA metabolism .


Forty-eight healthy volunteers participated in the randomized , placebo-controlled , double-blind , repeated-measure study .


At baseline , after @ , @ , @ and @ weeks , participants provided both fasting blood samples and @-h urine .


GAA intervention significantly increased serum and urinary GAA , Cr and creatinine as compared to placebo ( P < @ ) .


Differences were found for serum GAA and Cr responses between the three GAA dosages , with high-dose GAA resulting in a greater increase ( P < @ ) in the plasma concentration of both variables as compared to other GAA dosages .


In GAA groups , fasting plasma total homocysteine ( T-Hcy ) increased by @ mol/L on average at post-administration , yet no dose-response differences were found between trials .


Serum B vitamins were not affected by either placebo or GAA intervention ( P > @ ) .


Results indicate that low-to-high dosages of exogenous GAA can increase serum concentrations of Cr and T-Hcy while not depleting the B vitamins pool available for remethylation of homocysteine .


The objective of this trial was to assess which type of warm-up has the highest effect on virtual reality ( VR ) laparoscopy performance .


The following warm-up strategies were applied : a hands-on exercise ( group @ ) , a cognitive exercise ( group @ ) , and no warm-up ( control , group @ ) .


This is a @-arm randomized controlled trial .


The trial was conducted at the department of surgery of the University Hospital Basel in Switzerland .


A total of @ participants , all laypersons without any surgical or VR experience , completed the study .


A total of @ participants were randomized , @ to group @ , @ to group @ , and @ to group @ .


There were @ postrandomization exclusions .


In the multivariate analysis , we found no evidence that the intervention had an effect on VR performance as represented by @ calculated subscores of accuracy , time , and path length for ( @ ) camera manipulation and ( @ ) hand-eye coordination combined with @-handed maneuvers ( p = @ ) .


Neither the comparison of the average of the intervention groups ( groups @ and @ ) vs control ( group @ ) nor the pairwise comparisons revealed any significant differences in VR performance , neither multivariate nor univariate .


VR performance improved with increasing performance score in the cognitive exercise warm-up ( iPad @D puzzle ) for accuracy , time , and path length in the camera navigation task .


We were unable to show an effect of the @ tested warm-up strategies on VR performance in laypersons .


We are currently designing a follow-up study including surgeons rather than laypersons with a longer warm-up exercise , which is more closely related to the final task .


The purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor @ ( HER@ ) messenger RNA ( mRNA ) expression and efficacy in patients receiving trastuzumab plus docetaxel ( HT ) or trastuzumab emtansine ( T-DM@ ) .


Patients with HER@-positive , locally advanced or metastatic breast cancer ( MBC ) were randomly assigned to HT ( n = @ ) or T-DM@ ( n = @ ) .


HER@ status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing .


HER@ mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction .


HER@ mRNA levels were obtained for @/@ patients ( HT = @ ; T-DM@ = @ ) .


Median pretreatment HER@ mRNA was @ .


The risk of disease progression in the overall population was lower with T-DM@ than with HT ( hazard ratio ( HR ) = @ ; @ % confidence interval ( CI ) @ to @ ) .


This effect was more pronounced in patients with HER@ mRNAmedian ( HR = @ ; @ % CI @ to @ ) versus < median ( HR = @ ; @ % CI @ to @ ) .


In the T-DM@ arm , median progression-free survival ( PFS ) was not reached in patients with HER@ mRNAmedian and was @ months in patients with HER@ mRNA < median .


In the HT arm , PFS was @ versus @ months in patients with HER@ mRNAmedian versus < median , respectively .


The effect of HER@ mRNA expression on objective response rates was less pronounced .


This exploratory analysis suggests that while overall , patients with HER@-positive MBC show improved PFS with T-DM@ relative to HT , the effect is enhanced in patients with tumor HER@ mRNAmedian .


The behavioral outcome of food ingestion is a complex process that involves psychological and biological factors .


Avocados are nutrient dense with properties that may favorably impact energy balance .


This study sought to evaluate if incorporating approximately one half of a Hass avocado by addition or inclusion into a lunch meal will influence post-ingestive satiety , glucose and insulin response , and subsequent energy intake among overweight adults .


This was a randomized @ single-blind crossover design study with @ healthy overweight adults ( mean SD age @ years and BMI @ kg/m ) .


Participants consumed a standardized breakfast followed by @ of @ lunch test meals -LSB- Control ( C ) , avocado-free ; Avocado Inclusive ( AI ) ; and , Avocado Added ( AA ) -RSB- .


Participants rated five appetite sensations using a visual analog scale ( VAS ) before lunch and at specific intervals over @ hours following the start of the test meal .


Blood glucose and insulin were measured before lunch and at specific intervals over @ hours following the start of the test meal .


Mixed models were used to compare differences among the @ test meals , and the area under the curve ( AUC ( @-xh ) ) was computed for the VAS and biological measures .


There were significant differences in the AUC ( @-@h ) for the self-reported feelings of satisfaction ( P = @ ) and desire to eat ( P = @ ) in the mixed model analysis .


Compared to the C test meal , the AA test meal increased satisfaction by @ % ( P = @ ) and decreased the desire to eat by @ % ( P = @ ) for the AUC ( @-@h ) .


For the AUC ( @-@h ) , the AA test meal increased satisfaction by @ % ( P = @ ) and decreased the desire to eat by @ % ( P = @ ) as compared to the C test meal .


Compared to the AI meal , the AUC ( @-@h ) for blood insulin was higher in the C and AA meals ( P = @ and P = @ , respectively ) .


The addition of approximately one half of a Hass avocado at a lunch meal can influence post-ingestive satiety over a subsequent @ and @ hour period in overweight adults .


A caveat to these findings is that the avocado contained an additional @ kcal , which may have accounted for the observed increase in satisfaction and decreased desire to eat .


Future trials are warranted to evaluate the effects of avocado intake on weight management in adults of varying BMIs and among insulin resistant individuals .


We explored associations between mitochondrial DNA ( mtDNA ) haplogroups , epidermal nerve fiber density ( ENFD ) , and HIV-associated sensory neuropathy ( HIV-SN ) in a randomized trial of Thai patients initiating antiretroviral therapy ( ART ) .


The South East Asia Research Collaboration with Hawaii @ study evaluated toxicity of nucleoside reverse transcriptase inhibitors ( stavudine vs. zidovudine vs. tenofovir ) .


We present secondary analyses of mtDNA haplogroups and ENFD changes .


ENFD , peripheral blood mononuclear cell mitochondrial complex I and IV , and @-oxo-deoxyguanine ( @-oxo-dG ) were quantified .


Peripheral blood mononuclear cell mtDNA sequences were obtained for haplogroup determination .


Multivariate regression of ENFD change was performed .


Paired ENFD was available from @ patients .


Median age , CD@ cell count , and height at entry were @ years , @ cells/l , and @ cm , respectively .


Major haplogroups included M ( @ % ) , F ( @ % ) , and B ( @ % ) .


Baseline ENFD , CD@ cell count , randomized ART , and biomarkers did not differ by haplogroup .


Haplogroup B patients were older ( P = @ ) at baseline , and had an increase in median ENFD ( +@ vs. -@ fibers/mm ; P = @ ) and @-oxo-dG break frequency ( +@ vs. @ ; P = @ ) compared to other haplogroups .


In a multivariate model , haplogroup B was associated with increased ENFD ( = @ , P = @ ) at week @ , whereas older age ( P = @ ) , higher baseline CD@ cell count , ( P = @ ) , higher complex I level ( P = @ ) , and higher ENFD ( P < @ ) at baseline were all associated with decreased ENFD .


Three of the six HIV-SN cases were haplogroup B ( P = @ ) .


Thai persons belonging to mtDNA haplogroup B had increased ENFD and @-oxo-dG on ART , and were more likely to develop HIV-SN .


These results suggest that mtDNA variation influences early oxidative damage and ENFD changes .


Chronic post-surgical pain ( CPSP ) is a not uncommon complication after mastectomy , with a reported incidence between @ % and @ % .


Careful dissection , the use of minimally invasive surgical techniques , and attempts to reduce the associated inflammatory and hyperalgesic responses are suggested methods to prevent CPSP .


To determine if the use of perioperative lidocaine infusion is associated with decreased incidence of CPSP after mastectomy .


Double-blind , placebo-controlled randomized trial .


This is a secondary analysis of data from @ out of @ patients who underwent mastectomy for breast cancer .


Patients were randomized to either placebo ( Group P ; n = @ ) or intravenous lidocaine ( Group L ; n = @ , bolus @ mg/kg at induction , then infusion at @ mg/kg/hr , up to @ hours after the end of surgery ) in a prospective double-blind design .


CPSP was assessed at @ months after surgery .


Stepwise logistic regression analysis was performed to assess the efficacy of lidocaine .


Overall @ ( @ % ) patients developed CPSP , @ ( @ % ) in the placebo group and @ ( @ % ) in the lidocaine group .


Predictive factors for CPSP that remained significant after multivariate analysis included lidocaine ( associated with a @-fold decrease in CPSP , P = @ ) , breast implant placement ( associated with a @-fold increase in CPSP , P = @ ) , and radiotherapy ( associated with a @-fold increase in CPSP , P = @ ) .


Small sample size .


Perioperative lidocaine administration was associated with a decreased incidence of CPSP , while breast implant placement and radiotherapy were associated with an increased incidence .


These findings suggest a protective effect of lidocaine on CPSP development in mastectomy patients .


To compare quality of survival in `` standard-risk '' medulloblastoma after hyperfractionated radiation therapy of the central nervous system with that after standard radiation therapy , combined with a chemotherapy regimen common to both treatment arms , in the PNET@ randomised controlled trial .


Participants in the PNET@ trial and their parents/caregivers in @ participating anonymized countries completed standardized questionnaires in their own language on executive function , health status , behavior , health-related quality of life , and medical , educational , employment , and social information .


Pre - and postoperative neurologic status and serial heights and weights were also recorded .


Data were provided by @ of @ eligible survivors ( @ % ) at a median age at assessment of @ years and median interval from diagnosis of @ years .


Compared with standard radiation therapy , hyperfractionated radiation therapy was associated with lower ( ie , better ) z-scores for executive function in all participants ( mean intergroup difference @ SDs , @ % confidence interval @-@ @ , P = @ ) , but health status , behavioral difficulties , and health-related quality of life z-scores were similar in the @ treatment arms .


Data on hearing impairment were equivocal .


Hyperfractionated radiation therapy was also associated with greater decrement in height z-scores ( mean intergroup difference @ SDs , @ % confidence interval @-@ @ , P = @ ) .


Hyperfractionated radiation therapy was associated with better executive function and worse growth but without accompanying change in health status , behavior , or quality of life .


The aim of this study was to identify gender specific physical activity correlates in Danish preschool children , using a socioecological approach .


This was a cross-sectional study conducted in Odense , Denmark .


The gender specific models were based on data from @ boys and @ girls , @-@ years of age and enrolled in @ randomly selected preschools .


Percentage of total daily time spent in moderate and vigorously physical activity ( MVPA ) was measured using ActiGraph accelerometers over @ preschool days and @ days off .


Thirty-nine potential correlates of child MVPA across @ domains were tested for associations with gender specific MVPA .


The gender specific models consistently identified motor coordination and the parents ' perceptions of their child 's activity preferences during free play to be positively associated with MVPA .


Days with rain or no preschool attendance were negatively associated with MVPA .


For boys , rural area and the size of the preschool playground were positively associated with MVPA , whereas for girls , it was the age and the relative preschool indoor area .


Individual and overall environmental correlates of MVPA were identified .


However , most correlates were not or only weakly related to MVPA .


It is possible that the interaction with peers and surrounding adults might contribute the most to preschool child MVPA .


Based on findings that major depressive disorder ( MDD ) is associated to decreased dorsolateral prefrontal cortical ( DLPFC ) activity ; interventions that increase DLPFC activity might theoretically present antidepressant effects .


Two of them are cognitive control therapy ( CCT ) , a neurocognitive intervention that uses computer-based working memory exercises , and transcranial direct current stimulation ( tDCS ) , which delivers weak , electric direct currents over the scalp .


We investigated whether tDCS enhanced the effects of CCT in a double-blind trial , in which participants were randomized to sham tDCS and CCT ( n = @ ) vs. active tDCS and CCT ( n = @ ) .


CCT and tDCS were applied for @ consecutive workdays .


Clinicaltrials.gov identifier : NCT@ .


Both CCT alone and combined with tDCS ameliorated depressive symptoms after the acute treatment period and at follow-up , with a response rate of approximately @ % .


Older patients and those who presented better performance in the task throughout the trial ( possibly indicating greater engagement and activation of the DLPFC ) had greater depression improvement in the combined treatment group .


Our exploratory findings should be further confirmed in prospective controlled trials .


CCT and tDCS combined might be beneficial for older depressed patients , particularly for those who have cognitive resources to adequately learn and improve task performance over time .


This combined therapy might be specifically relevant in this subgroup that is more prone to present cognitive decline and prefrontal cortical atrophy .


To evaluate if the use of Valleylab mode ( `` V mode '' ) ( Covidien , Mansfield , MA ) electrothermal energy for colpotomy during total laparoscopic hysterectomy ( LH ) results in a smaller margin of thermal injury to the upper vagina compared with traditional cut/coagulate ( cut/coag ) electrothermal energy .


Prospective randomized clinical trial ( Canadian Task Force classification I ) .


University medical center .


A total of @ subjects who underwent LH between June @ and August@ .


Subjects were randomized to colpotomy by V mode electrothermal energy or cut/coag electrothermal energy .


The primary end point was the median depth of thermal injury measured in millimeters .


The secondary end points included the proportion of subjects who developed granulation tissue , induration , infection , or dehiscence at the vaginal cuff at @weeks , @months , or @months postoperatively .


There was no significant difference in the median depth of thermal injury in the cut/coag and V mode arms ( anterior margin : @ mm vs @ mm -LSB- p = @ -RSB- , posterior margin : @ mm vs @ mm -LSB- p = @ -RSB- , respectively ) .


Twenty-seven percent of subjects in each arm developed at least @ of the clinical end points at @weeks , @months , or @months postoperatively ( granulation tissue : @ % -@ % vs @ % -@ % , induration : @ % -@ % vs @ % -@ % , infection : @ % -@ % vs @ % -@ % , dehiscence : @ % vs @ % in the cut/coag and V mode arms , respectively ) , with no difference between arms ( p = @ ) .


The V mode does not reduce the depth of thermal injury compared with cut/coag electrothermal energy when used for colpotomy incision during total laparoscopic hysterectomy ( Clinical Trials.gov ID : NCT@ ) .


To evaluate the antimicrobial activity of a new , transparent composite film dressing , whose adhesive contains chlorhexidine gluconate ( CHG ) , against the native microflora present on human skin .


CHG-containing adhesive film dressings and non-antimicrobial control film dressings were applied to the skin on the backs of healthy human volunteers without antiseptic preparation .


Dressings were removed @ , @ or @ days after application .


The bacterial populations underneath were measured by quantitative cultures ( cylinder-scrub technique ) and compared with one another as a function of time .


The mean baseline microflora recovery was @ log@ cfu/cm ( @ ) .


The mean log reductions from baseline measured from underneath the CHG-containing dressings were @ , @ and @ log@ cfu/cm ( @ ) on days @ , @ and @ , respectively , compared with log reductions of @ , -@ and -@ log@ cfu/cm ( @ ) from underneath the control film dressings .


There was no significant difference between the log reductions of the two treatments on day @ , but on days @ and @ the log reduction associated with the CHG adhesive was significantly higher than that associated with the control adhesive .


The adhesive containing CHG was associated with a sustained antimicrobial effect that was not present in the control .


Incorporating the antimicrobial into the adhesive layer confers upon it bactericidal properties in marked contrast to the non-antimicrobial adhesive , which contributed to bacterial proliferation when the wear time was @ days .


Third-generation coronary drug-eluting stents ( DES ) with biodegradable polymers have been designed to improve safety and efficacy .


We designed a large scale registry-based randomized clinical trial to compare @ third-generation DES : a thin strut , cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer ( O-SES , Orsiro ; Biotronik , Blach , Switzerland ) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents ( N-BES , Nobori ; Terumo , Tokyo , Japan ) in an all-comer patient population .


The multicenter SORT OUT VII trial ( NCT@ ) randomly assigned @,@ patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at @ sites in Western Denmark .


Patients were eligible , if they were @ years old ; had chronic stable coronary artery disease or acute coronary syndromes ; and @ coronary lesion with > @ % diameter stenosis , requiring treatment with a DES .


The primary end point target lesion failure is a composite of cardiac death , myocardial infarction ( not related to other than index lesion ) , or target lesion revascularization within @ months .


Clinically , driven event detection based on Danish registries will be used .


An event rate of @ % is assumed in each stent group .


With a sample size of @,@ patients in each treatment arm , a @-group large-sample normal approximation test of proportions with a @-sided @ % significance level will have @ % power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of @ % .


The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event .


Nivolumab , a fully human IgG@ PD-@ immune checkpoint inhibitor antibody , can result in durable responses in patients with melanoma who have progressed after ipilimumab and BRAF inhibitors .


We assessed the efficacy and safety of nivolumab compared with investigator 's choice of chemotherapy ( ICC ) as a second-line or later-line treatment in patients with advanced melanoma .


In this randomised , controlled , open-label , phase @ trial , we recruited patients at @ sites in @ countries .


Eligible patients were @ years or older , had unresectable or metastatic melanoma , and progressed after ipilimumab , or ipilimumab and a BRAF inhibitor if they were BRAF ( V @ ) mutation-positive .


Participating investigators randomly assigned ( with an interactive voice response system ) patients @:@ to receive an intravenous infusion of nivolumab @ mg/kg every @ weeks or ICC ( dacarbazine @ mg/m ( @ ) every @ weeks or paclitaxel @ mg/m ( @ ) combined with carboplatin area under the curve @ every @ weeks ) until progression or unacceptable toxic effects .


We stratified randomisation by BRAF mutation status , tumour expression of PD-L@ , and previous best overall response to ipilimumab .


We used permuted blocks ( block size of six ) within each stratum .


Primary endpoints were the proportion of patients who had an objective response and overall survival .


Treatment was given open-label , but those doing tumour assessments were masked to treatment assignment .


We assessed objective responses per-protocol after @ patients had been treated with nivolumab and had a minimum follow-up of @ weeks , and safety in all patients who had had at least one dose of treatment .


The trial is closed and this is the first interim analysis , reporting the objective response primary endpoint .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Dec @ , @ , and Jan @ , @ , we screened @ patients , randomly allocating @ patients to nivolumab and @ to ICC .


Confirmed objective responses were reported in @ ( @ % , @ % CI @-@ ) of the first @ patients in the nivolumab group versus five ( @ % , @-@ ) of @ patients in the ICC group .


Grade @-@ adverse events related to nivolumab included increased lipase ( three -LSB- @ % -RSB- of @ patients ) , increased alanine aminotransferase , anaemia , and fatigue ( two -LSB- @ % -RSB- each ) ; for ICC , these included neutropenia ( @ -LSB- @ % -RSB- of @ ) , thrombocytopenia ( six -LSB- @ % -RSB- ) , and anaemia ( five -LSB- @ % -RSB- ) .


We noted grade @-@ drug-related serious adverse events in @ ( @ % ) nivolumab-treated patients and nine ( @ % ) patients in the ICC group .


No treatment-related deaths occurred .


Nivolumab led to a greater proportion of patients achieving an objective response and fewer toxic effects than with alternative available chemotherapy regimens for patients with advanced melanoma that has progressed after ipilimumab or ipilimumab and a BRAF inhibitor .


Nivolumab represents a new treatment option with clinically meaningful durable objective responses in a population of high unmet need .


To investigate the effect of stretch-and-flow voice therapy on vocal function and handicap .


Randomized controlled trial .


Participants with primary muscle tension dysphonia were randomly assigned to experimental or control groups .


Experimental participants received vocal hygiene education followed by @ weeks of stretch-and-flow voice therapy .


Control participants received vocal hygiene education only .


Outcome variables consisted of a measure of vocal handicap ( Voice Handicap Index -LSB- VHI -RSB- ) , maximum phonation time , s/z ratio , and acoustic measures .


All measures were obtained at baseline prior to treatment and within @ weeks posttreatment or at the end of the control period .


The pre - to posttreatment measurement change ( delta ) was applied to statistical analyses .


A multivariate analysis of variance revealed significant group differences in pre-to-post changes on measures of VHI , maximum phonation time , and cepstral peak prominence ( CPP ) in connected speech and vowels ( P = @ , @ , @ , and @ respectively ) , with a significant reduction of VHI ( Cohen 's d = @ ) , increase in maximum phonation time ( Cohen 's d = @ ) , increase of CPP in connected speech ( Cohen 's d = @ ) , and increase of CPP in vowels ( Cohen 's d = @ ) in the experimental group compared to the control group .


This preliminary small sample randomized controlled trial found significantly greater improvement in vocal handicap , maximum phonation time , and acoustic measures of vocal function after participants received stretch-and-flow voice therapy compared to participants receiving vocal hygiene education alone .


Additional research incorporating larger samples will be needed to confirm and further investigate these findings .


To examine the impact of providing rapid diagnostic tests for malaria on fever management in private drug retail shops where most poor rural people with fever present , with the aim of reducing current massive overdiagnosis and overtreatment of malaria .


Cluster randomized trial of @ clusters of shops .


Dangme West , a poor rural district of Ghana .


Shops and their clients , both adults and children .


Providing rapid diagnostic tests with realistic training .


The primary outcome was the proportion of clients testing negative for malaria by a double-read research blood slide who received an artemisinin combination therapy or other antimalarial .


Secondary outcomes were use of antibiotics and antipyretics , and safety .


Of @ clients , @ ( @ % ) tested negative by double-read research slides .


The proportion of slide-negative clients who received any antimalarial was @/@ ( @ % ) in the intervention arm and @/@ ( @ % ) in the control arm ( adjusted risk ratio @ ( @ % CI @ to @ ) , P < @ ) .


Treatment was in high agreement with rapid diagnostic test result .


Of those who were slide-positive , @/@ ( @ % ) in the intervention arm and @/@ ( @ % ) in the control arm received an artemisinin combination therapy ( adjusted risk ratio @ ( @ to @ ) ) .


There was no evidence of antibiotics being substituted for antimalarials .


Overall , @/@ ( @ % ) clients in the intervention arm and @/@ ( @ % ) in the control arm received appropriate treatment ( adjusted risk ratio @ ( @ to @ ) , P < @ ) .


No safety concerns were identified .


Most patients with fever in Africa present to the private sector .


In this trial , providing rapid diagnostic tests for malaria in the private drug retail sector significantly reduced dispensing of antimalarials to patients without malaria , did not reduce prescribing of antimalarials to true malaria cases , and appeared safe .


Rapid diagnostic tests should be considered for the informal private drug retail sector.Registration Clinicaltrials.gov NCT@ .


Stringent control of proteolytic activity represents a major therapeutic approach for wound-bed preparation .


We tested whether a protease-modulating polyacrylate - ( PA - ) containing hydrogel resulted in a more efficient wound-bed preparation of venous leg ulcers when compared to an amorphous hydrogel without known protease-modulating properties .


Patients were randomized to the polyacrylate-based hydrogel ( n = @ ) or to an amorphous hydrogel ( n = @ ) .


Wound beds were evaluated by three blinded experts using photographs taken on days @ , @ and @ .


After @ days of treatment there was an absolute decrease in fibrin and necrotic tissue of @ @ percentage points in the PA-based hydrogel group and by @ @ percentage points in the amorphous hydrogel group .


The absolute increase in the proportion of ulcer area covered by granulation tissue was @ @ percentage points in the PA-based hydrogel group and @ @ percentage points in the control group .


The differences between the groups were significant ( decrease in fibrin and necrotic tissue P = @ and increase in granulation tissue P = @ , respectively ) .


In particular , long-standing wounds profited from the treatment with the PA-based hydrogel .


These data suggest that PA-based hydrogel dressings can stimulate normalization of the wound environment , particularly in hard-to-heal ulcers .


To determine the efficacy of a multivalent modified-live virus ( MLV ) vaccine containing a Mannheimia haemolytica toxoid to reduce pneumonia and mortality rate when administered to calves challenge exposed with virulent Bibersteinia trehalosi .


Animals-@ Holstein calves .


Calves were assigned to @ treatment groups .


Calves in the control group ( n = @ ) were vaccinated by SC administration of @ mL of a commercial @-way MLV vaccine , and calves in the other group ( @ ) were vaccinated by SC administration of a @-mL dose of a @-way MLV vaccine containing M haemolytica toxoid ( day @ ) .


On day @ , calves were transtracheally administered B trehalosi .


Serum was obtained for analysis of antibody titers against M haemolytica leukotoxin .


Nasopharyngeal swab specimens were collected from calves @ day before vaccination ( day -@ ) and challenge exposure ( day @ ) and cultured to detect bacterial respiratory pathogens .


Clinical scores , rectal temperature , and death attributable to the challenge-exposure organism were recorded for @ days after challenge exposure .


Remaining calves were euthanized at the end of the study .


Necropsy was performed on all calves , and lung lesion scores were recorded .


Calves vaccinated with the MLV vaccine containing M haemolytica toxoid had significantly lower lung lesion scores , mortality rate , and clinical scores for respiratory disease , compared with results for control calves .


Administration of a multivalent MLV vaccine containing M haemolytica toxoid protected calves against challenge exposure with virulent B trehalosi by reducing the mortality rate , lung lesion scores , and clinical scores for respiratory disease .


To investigate phone follow-up with a semiquantitative urine pregnancy test and symptom checklist as a replacement for universal clinic follow-up after medical abortion .


One thousand four hundred thirty-three women seeking early medical abortion at four hospitals in Vietnam were randomized to clinic or phone follow-up .


Women allocated to clinic follow-up returned to the hospital for confirmation of abortion outcome @ weeks after mifepristone administration .


Women assigned to phone follow-up completed a semiquantitative pregnancy test at initial visit to determine baseline human chorionic gonadotropin range and again at home @ weeks later .


Clinic staff called women to review the pregnancy test results and symptom checklist .


Women who screened positive were referred to the clinic .


Effectiveness , feasibility , and acceptability of the follow-up methods were assessed .


The rate of ongoing pregnancy was not significantly different between the two groups ( clinic : @ % phone , @ % , relative risk @ , @ % confidence interval @-@ @ ) .


Eighty-five percent of women in the phone group did not need an additional clinic visit .


Phone follow-up was highly effective in screening for ongoing pregnancy with a sensitivity and specificity of @ % and @ % , respectively .


Specificity of the pregnancy test alone ( eg , without the symptom checklist ) was higher ( @ % ) .


Phone follow-up offers a feasible and effective approach to identify women with ongoing pregnancy after early medical abortion .


When used with the semiquantitative pregnancy test , the symptom checklist offered no additional benefit and decreased the specificity of the screening .


Given its effectiveness and ease of use , the semiquantitative pregnancy test alone could replace routine clinic follow-up after early medical abortion .


Weight loss interventions often present small mean weight changes over time , despite the fact that a substantial proportion of the participants lost more weight .


This effect is often leveled out by the substantial proportion of participants who gained weight during the trial .


The aim of this study is to identify and describe distinct subgroups of participants with different weight change trajectories during and after a weight loss intervention .


We used data from a weight loss intervention that was part of a randomized controlled trial on the preventive effect of a tailor-made weight loss intervention and oral glucosamine sulfate on the incidence of knee osteoarthritis in @ overweight women aged @ to @years .


Latent class growth analysis ( LCGA ) was used to identify subgroups of participants with different weight change trajectories over time .


Using LCGA , we identified three subgroups with different trajectories of weight change , one large group ( n = @ ) with almost no change over time , and two smaller groups ( both n = @ ) , of which one represents participants who steadily gained weight over time , whereas the other represents participants who steadily lost weight over time .


Participants that had relatively low body weight around their @th year of life and that gained weight in the year preceding the study were most likely to belong to the group that lost weight .


LCGA was a suitable method to identify three distinct groups of participants with different trajectories of weight change .


Low body weight at age @ and weight gain in the year preceding the study were associated with a higher chance of membership of thegroup that lost weight .


It seems weight loss that occurred during this weight loss intervention was mostly recently gained weight .


To analyze the clinical characteristics of a serous retinopathy associated with mitogen-activated protein kinase kinase ( MEK ) inhibition with binimetinib treatment for metastatic cutaneous melanoma ( CM ) and uveal melanoma ( UM ) , and to determine possible pathogenetic mechanisms that may lead to this retinopathy .


Prospective observational , cohort-based , cross-sectional study .


Thirty CM patients and @ UM patients treated with the MEK inhibitor binimetinib ( CM ) or a combination of binimetinib and the protein kinase C inhibitor sotrastaurin ( UM ) .


Extensive ophthalmic examination was performed , including Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity , applanation tonometry , slit-lamp examination , indirect ophthalmoscopy , digital color fundus photography , and optical coherence tomography ( OCT ) .


In selected cases , additional examinations were performed , including visual field testing and electro-oculography ( EOG ) .


Blood samples were obtained from @ CM patients and @ UM patients to analyze the presence of autoantibodies against retinal and retinal pigment epithelium ( RPE ) proteins .


Visual symptoms , visual acuity , fundus appearance , characteristics on OCT , fundus autofluorescence ( FAF ) , and EOG .


Six CM patients ( @ % ) and @ UM patients ( @ % ) reported visual symptoms during the study .


The median time to the onset of symptoms , which were all mild and transient , was @ days ( range , < @ hour to @ weeks ) .


On OCT , subretinal fluid ( SRF ) was detected in @ % of CM patients and @ % of UM patients .


In the @ patients with SRF , the fovea was affected in @ % .


After the start of the medication , an EOG was performed in @ eyes of @ patients ; @ of these eyes ( @ % ) developed SRF on OCT. .


Fifteen of these eyes ( @ % ) showed an abnormal Arden ratio ( < @ ) .


A broad pattern of anti-retinal antibodies was found in @ CM patients and @ UM patients tested , whereas anti-RPE antibodies were detected in all @ tested patients .


A time-dependent and reversible serous retinopathy can develop both in patients with metastatic CM and UM treated with binimetinib .


A minority of patients develop visual symptoms , which are generally mild and transient .


A cause of binimetinib-associated serous retinopathy may be toxicity of medication , but autoantibodies also may be involved .


Leukocytapheresis is an extracorporeal therapy for ulcerative colitis .


However , no large-scale study on leukocytapheresis has been reported .


This large-scale , prospective , observational study aimed to evaluate the treatment outcomes of leukocytapheresis for active ulcerative colitis in clinical practice .


Patients with active ulcerative colitis treated with leukocytapheresis using a Cellsorba E column between May @ and December @ were enrolled from @ medical facilities in Japan .


A total of @ patients were enrolled , and @ were available for efficacy analysis .


Out of @ patients , @ % of the patients had moderate to severe disease activity , and @ % were steroid refractory .


As concomitant medications , @-aminosalicylic acids , corticosteroids , and thiopurines were administered to @ % , @ % , and @ % of the patients , respectively .


In addition , infliximab and tacrolimus were concomitantly used in @ % and @ % , respectively .


Intensive leukocytapheresis ( @ leukocytapheresis sessions within the first @ weeks ) was used in > @ % of the patients .


Adverse events were seen in @ % ( @/@ ) , which were severe in only @ patients ( @ % ) .


Any concomitant medications did not increase the incidence of adverse events .


Intensive leukocytapheresis was as safe as the conventional weekly procedure .


The overall clinical remission rate was @ % ( @/@ ) , and the mucosal healing rate was @ % ( @/@ ) .


Clinical remission was achieved more frequently and rapidly in the intensive group than in the weekly group .


This large-scale study indicates that leukocytapheresis , including intensive procedure , is a safe and effective therapeutic option for active ulcerative colitis .


The anaesthetic potency of intravenous propofol is quantified by its Cp@ value , which is defined as the plasma concentration required to prevent movement response in @ % of patients to surgical stimuli .


We hypothesised that , in addition to propofol anaesthesia , an intravenous bolus of lidocaine @ mg/kg will decrease the Cp@ value of propofol during anaesthesia .


We enrolled @ elective surgical patients undergoing propofol-based anaesthesia , and randomised them to either lidocaine @ mg/kg , lidocaine @ mg/kg or placebo ( NaCl @ % ) @min before skin incision .


The propofol Cp@ value was then calculated using the ` up-and-down ' method of Dixon and Massey .


There was no significant reduction in propofol requirements after the administration of @ mg/kg lidocaine from @ g/ml -LSB- confidence interval ( CI ) @-@ @ -RSB- to @ g/ml ( CI @-@ @ ) ; however , a bolus of @ mg/kg lidocaine decreased the Cp@ value of propofol by @ % from @ g/ml ( CI @-@ @ ) to @ g/ml ( CI @-@ @ ) ( P < @ ) .


An intravenous bolus injection of @ mg/kg lidocaine @ % caused a significant reduction of the propofol Cp@ value .


The purpose of this study was to compare the success rate of monocanalicular versus that of bicanalicular silicone intubations of the nasolacrimal duct for nasolacrimal duct stenosis ( NLDS ) in adults ( patent nasolacrimal duct with resistance to positive-pressure irrigation ) .


In a prospective randomized clinical trial , @ eyes of @ patients with NLDS underwent either monocanalicular silicone intubation ( MCI ) ( n = @ eyes ) or bicanalicular silicon intubation ( BCI ) ( n = @ eyes ) .


All procedures were performed by @ oculoplastic surgeon .


Tube removal was planned for @ months postoperatively .


Treatment success was defined as the complete resolution of epiphora or intermittent epiphora with normal dye disappearance test at @ months after tube removal .


The surgical outcome was assessed in @ eyes with MCI and @ eyes with BCI .


The mean ( SD ) age of treatment was @ ( @ ) years for MCI and @ ( @ ) years for BCI .


Treatment success was achieved in @ of @ eyes ( @ % ) in the MCI group compared with @ of @ eyes ( @ % ) in the BCI group .


Differences between the @ groups proved to be not significant ( P = @ ) .


The only complication was peripunctal pyogenic granuloma in @ eyes with BCI .


Both MCI and BCI were successful in a similar percentage of patients with NLDS .


The main advantages of the former technique were simple insertion and easy removal of the tube .


Levobupivacaine use is progressively increased for intrathecal anesthesia in transurethral resections .


The aim was to determine ED ( @ ) and ED ( @ ) of intrathecal isobaric levobupivacaine by addition of @mcg fentanyl for patients undergoing transurethral resections .


A total of @ patients undergoing transurethral resections with ASA I-III , were randomized to groups receiving intrathecal @ % isobaric levobupivacaine in doses of @ , @ , @ , @ or @mg in equal volumes with @mcg intrathecal fentanyl addition .


Sensorial block level was determined by pinprick and motor block by Bromage scale .


Mean onset time of sensorial block in @mg group was significantly longer than that of sensorial block in @mg , @mg and @mg groups ( p < @ ) , @mg was longer than @mg and @mg ( p < @ ) , and @mg onset time of sensorial block was significantly longer than @mg and @mg ( p < @ ) .


Mean onset time of T@ sensory level in @mg group was significantly longer than mean onset time of T@ sensory level in @mg , @mg and @mg ( p < @ ) , the mean onset time of T@ sensory level in @mg group was also significantly longer than that of @mg , @mg groups ( p < @ ) .


ED ( @ ) and ED ( @ ) of levobupivacaine coadministered with @ mcg fentanyl were @ mg and @ mg , respectively .


Levobupivacaine with opioid co-administration can be used in doses considerably lower than doses proposed for routine use as it is a safe drug depending on its hemodynamic effects , side effects .


The aim of this study was to compare the effects of epidural analgesia with infiltration analgesia in postoperative pain control for total knee arthroplasty .


Thirty patients ( @ female , @ male ; mean age : @ years , range : @ to @ years ) undergoing total knee arthroplasty between May @ and September @ were randomly divided into @ groups .


All patients received spinal anesthesia with bupivacaine .


Postoperative analgesia of @ ml @ % NaCl + @ ml bupivacaine ( @ ml = @ mg , total @ ml ) was administered throughout @ hours to Group @ ( n = @ ) by epidural catheter and to Group @ ( n = @ ) by ON-Q infiltration pump .


Groups were compared based on the Bromage scores and visual analog scale ( VAS ) , blood pressure , postoperative analgesia requirement and side effects .


Demographic data were similar in both groups .


Rates of additional analgesia requirement at the postoperative @th minute and @nd hour were significantly higher in Group @ than Group @ ( p < @ ) .


Rates of nausea-vomiting at the postoperative @th minute and @nd hour were significantly higher in Group @ than Group @ ( p < @ and p < @ , respectively ) .


Bromage scores at @ minutes and @ hours was significantly higher in Group @ than in Group @ ( p < @ ) .


Mean VAS scores at @ minutes and @ hours were significantly higher in Group @ than Group @ ( p < @ ) .


While a statistically significant difference was found between systolic arterial pressure measurements at @ minutes ( p < @ ) , there was no significant difference in diastolic arterial pressure and peak heart rate .


Although the analgesic effect of local infiltration is provided later than by epidural analgesia , the same level of pain control can be achieved with initial additional analgesia .


Local infiltration is superior to epidural analgesia in respect of few side effects and early mobilization .


To evaluate whether implantation of an aspheric intraocular lens ( IOL ) results in reduced ocular aberrations and improved contrast sensitivity after cataract surgery and , therefore , changes on frequency-doubling technology ( FDT ) testing .


The present prospective clinical study enrolled @ patients with bilateral cataract ( @ eyes ) , who randomly received either an aspheric ( Akreos AO ) or a spherical ( Akreos Fit ) IOL in one eye and the other IOL in the second eye .


Assessment @ months postoperatively included photopic and mesopic contrast sensitivity testing .


Higher-order aberrations ( HOAs ) were computed .


FDT testing was divided into four areas to evaluate the variation of the values at different points .


The median values of the local pattern thresholds ( median area contrast sensitivity -LSB- MACS -RSB- ) obtained with that division were calculated .


The Akreos AO group obtained statistically significantly lower values of HOAs and spherical aberration compared with the Akreos Fit group .


There was a statistically significant between-group difference in contrast sensitivity under mesopic conditions at all spatial frequencies .


No statistically significant differences were observed in mean deviation and pattern standard deviation .


The aspheric IOL exhibited higher MACS in all areas , although a statistically significant difference was reached only in the @-degree field area ( P = @ ) .


Aspheric IOLs significantly reduced spherical aberration and HOAs , improving mesopic contrast sensitivity .


Although there was a trend toward slightly improved FDT in the aspheric IOL group , it was not statistically significant .


Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries .


However , according to the labor inspectorate , more than @ % of Dutch construction sites violate safety regulations for working from heights .


To increase compliance with safety regulations , employers and workers have to select , implement and monitor safety measures .


To facilitate this behavioral change , stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques .


For this study , two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate .


These strategies consist of @ ) face-to-face contacts with safety consultants and @ ) direct mail with access to internet facilities .


The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights , the process and the cost measures .


This study is a block randomized intervention trial in @ cities to establish the effects of the face-to-face guidance strategy ( N = @ ) , a direct mailing strategy ( N = @ ) and a control condition of no guidance ( N = @ ) on safety violations to record by labor inspectors after three months .


A process evaluation for both strategies will be performed to determine program implementation ( reach , dose delivered and dose received ) , satisfaction , knowledge and perceived safety behavior .


A cost analysis will be performed to establish the financial costs for both strategies .


The present study is in accordance with the CONSORT statement .


This study increases insight into performing practice-based randomized controlled trials .


The outcome will help to evaluate the effect of two guidance strategies on safety violations .


If these strategies are effective , implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with safety regulations .


Understanding mechanisms linking neighborhood context to health behaviors may provide targets for increasing lifestyle intervention effectiveness .


Although associations between home neighborhood and obesogenic behaviors have been studied , less is known about the role of worksite neighborhood .


To evaluate associations between worksite neighborhood context at baseline ( @ ) and change in obesogenic behaviors of adult employees at follow-up ( @-@ ) in a worksite randomized trial to prevent weight gain .


Worksite property values were used as an indicator of worksite neighborhood SES ( NSES ) .


Worksite neighborhood built environment attributes associated with walkability were evaluated as explanatory factors in relationships among worksite NSES , diet , and physical activity behaviors of employees .


Behavioral data were collected at baseline ( @-@ ) and follow-up ( @-@ ) .


Multilevel linear and logistic models were constructed adjusting for covariates and accounting for clustering within worksites .


Product-of-coefficients methods were used to assess mediation .


Analyses were performed after study completion ( @-@ ) .


Higher worksite NSES was associated with more walking ( OR = @ , @ % CI = @ , @ , p = @ ) .


Higher density of residential units surrounding worksites was associated with more walking and eating five or more daily servings of fruits and vegetables , independent of worksite NSES .


Residential density partially explained relationships among worksite NSES , fruit and vegetable consumption , and walking .


Worksite neighborhood context may influence employees ' obesogenic behaviors .


Furthermore , residential density around worksites could be an indicator of access to dietary and physical activity-related infrastructure in urban areas .


This may be important given the popularity of worksites as venues for obesity prevention efforts .


To analyze the differences between biodegradable and nondegradable nasal dressings with regard to their effects on wound healing in the short and medium term and on surgical outcomes in the long term , after endoscopic sinus surgery ( ESS ) .


A prospective , randomized , partly blinded , controlled trial .


A total of @ patients undergoing bilateral ESS for chronic rhinosinusitis with polyposis were enrolled and randomized to receive biodegradable ( Nasopore ; Stryker , Hamilton , ON , Canada ) on one side and nondegradable packing ( Merocel ; Medtronic Xomed , Minneapolis , MN ) on the opposite side .


Postoperative morbidities ( pain , bleeding , facial edema , nasal blockage ) related to dressings were assessed on postoperative day @ .


Wound healing ( edema , crusting , secretions , synechia , granulation tissue formation , and percentage re-epithelialization ) were evaluated at @ weeks , @ month , @ months , and @ months using modified Lund-Kennedy scores .


Long-term assessment at @ months was done using validated Lund-Kennedy scores .


Morbidities related to nondegradable packing were significantly higher than with degradable packing ( Wilcoxon signed rank test , P < @ ) .


Pain , bleeding , nasal blockage , and facial edema were significantly less with absorbable packing .


No statistically significant difference was found between sinonasal cavities packed with biodegradable or nondegradable materials with regard to healing scores and percentage of re-epithelialization at @ weeks , @ month , @ months , @ months , and surgical outcomes at @ year ( P > @ ) .


However , healing at @ months was correlated with the preoperative Lund-Mackay radiology and surgery scores ( Spearman 's rho correlation test , P < @ and P < @ , respectively ) .


No significant healing or surgical outcome differences were found between biodegradable and nondegradable packing .


However pain , bleeding , nasal blockage , and facial edema were lower with biodegradable packing .


Even after quitting illicit drugs , tobacco abuse remains a major cause of morbidity and mortality in former injection drug users .


An important unmet need in this population is to have effective interventions that can be used in the context of community based care .


Contingency management , where a patient receives a monetary incentive for healthy behavior choices , and incorporation of individual counseling regarding spirometric `` lung age '' ( the age of an average healthy individual with similar spirometry ) have been shown to improve cessation rates in some populations .


The efficacy of these interventions on improving smoking cessation rates has not been studied among current and former injection drug users .


In a randomized , factorial design study , we recruited @ active smokers from an ongoing cohort study of current and former injection drug users to assess the impact of contingency management and spirometric lung age on smoking cessation .


The primary outcome was @-month biologically-confirmed smoking cessation comparing contingency management , spirometric lung age or both to usual care .


Secondary outcomes included differences in self-reported and biologically-confirmed cessation at interim visits , number of visits attended and quit attempts , smoking rates at interim visits , and changes in Fagerstrom score and self-efficacy .


Six-month biologically-confirmed smoking cessations rates were @ % usual care , @ % lung age , @ % contingency management and @ % for combined lung age and contingency management ( p = @ ) .


There were no differences in secondary endpoints comparing the four interventions or when pooling the lung age groups .


Comparing contingency management to non-contingency management , @-month cessation rates were not different ( @ % vs. @ % ; p = @ ) , but total number of visits with exhaled carbon monoxide-confirmed abstinence were higher for contingency management than non-contingency management participants ( @ vs. @ ; p = @ ) , and more contingency management participants showed reduction in their Fagerstrom score from baseline to follow-up ( @ % vs. @ % ; p = @ ) .


While lung age appeared ineffective , contingency management was associated with more short-term abstinence and lowered nicotine addiction .


Contingency management may be a useful tool in development of effective tobacco cessation strategies among current and former injection drug users .


Obese women have poorer in vitro fertilization outcomes , but underlying mechanisms remain unclear .


The objectives of the study were to compare the pharmacokinetics of human chorionic gonadotropin ( hCG ) and ovarian steroid hormone production , after subcutaneous ( s.c. ) and intramuscular ( i.m. ) injection of hCG in obese and normal-weight women .


This was a randomized , experimental study .


Twenty-two women aged @-@ years with body mass index of @-@ @ ( normal ) or @-@ kg/m ( @ ) ( obese ) .


Participants received im urinary hCG or s.c. recombinant hCG and returned for a second injection type after a @-week washout .


Intramuscular injections were performed under ultrasound guidance .


Blood was taken @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ hours after injection .


hCG was measured at each time point ; estradiol , progesterone , @-hydroxyprogesterone ( @-OHP ) , testosterone ( T ) , dehydroepiandrosterone , and SHBG were measured at @ and @ hours .


Twenty-two women completed the study .


In both normal-weight and obese women , peak serum concentration ( Cmax ) , area under the curve ( AUC ) , and average hCG concentration were higher after i.m. injection as compared with s.c. injection ( all P < @ ) .


Obese women had markedly lower Cmax , AUC , and average hCG concentration after s.c. injection as compared with normal-weight women ( P = @ , P = @ , and P = @ , respectively ) .


After i.m. injection , Cmax , AUC , and average concentration were similar for normal-weight and obese women ( P = @ , P = @ , and P = @ , respectively ) .


Thirty-six percent of obese women had muscular layers beyond the reach of a standard @ inch needle .


hCG caused a significant rise in @-OHP in both obese and normal-weight women and an increase in T in obese but not normal-weight women ( all P < @ ) .


Subcutaneous injection yields lower hCG levels in obese women .


Standard-length needles are insufficient to administer i.m. injections in many obese women .


The use of @-h ambulatory blood pressure monitoring ( ABPM ) in clinical practice and observational epidemiological studies has grown considerably in the past @ years .


ABPM is a very effective technique for assessing biological , environmental , and drug effects on blood pressure .


In order to enhance the effectiveness of ABPM for clinical and observational research studies using analytical and graphical results , developing alternative data analysis approaches using modern statistical techniques are important .


The linear mixed model for the analysis of longitudinal data is particularly well suited for the estimation of , inference about , and interpretation of both population ( mean ) and subject-specific trajectories for ABPM data .


We propose using a linear mixed model with orthonormal polynomials across time in both the fixed and random effects to analyze ABPM data .


We demonstrate the proposed analysis technique using data from the Dietary Approaches to Stop Hypertension ( DASH ) study , a multicenter , randomized , parallel arm feeding study that tested the effects of dietary patterns on blood pressure .


The linear mixed model is relatively easy to implement ( given the complexity of the technique ) using available software , allows for straightforward testing of multiple hypotheses , and the results can be presented to research clinicians using both graphical and tabular displays .


Using orthonormal polynomials provides the ability to model the nonlinear trajectories of each subject with the same complexity as the mean model ( fixed effects ) .


Anterior knee pain may occur after total knee arthroplasty ( TKA ) .


Patellar resurfacing , which is considered to lower the incidence of anterior knee pain after TKA , remains controversial .


In the present study clinical and radiological outcomes after TKA performed on patients with clinical and radiological signs of femorotibial and patellofemoral osteoarthritis ( OA ) with and without patellar resurfacing will be compared .


Fifty patients will be included in a randomized controlled trial .


Patients scheduled for TKA with clinical and radiological signs of femorotibial and patellofemoral OA will be included .


Arthritis of the patellofemoral joint was determined based on the preoperative Baldini and Merchant X-ray views , which is assessed by the orthopaedic surgeon who treats the patient .


Exclusion criteria are rheumatoid arthritis , history of patellar fracture , tuberosity transposition , high tibial osteotomy ( HTO ) , hip arthroplasty and posterior cruciate ligament insufficiency .


Patients will be randomized to undergo TKA either with or without patellar resurfacing .


Outcomes will be assessed preoperatively , at @ weeks and at @ , @ , @ and @ months postoperatively .


Primary outcome measure is the patellofemoral scoring system according to Baldini .


Secondary outcome measures are the Knee Society clinical rating system ( KSS ) and the Knee Osteoarthritis Outcome Scale ( KOOS ) scores .


Conventional weight-bearing radiographs , and views according to Baldini will be used to asses component loosening , wear , and patellofemoral problems including fracture or loosening of resurfaced patellae , subluxation and wear of non-resurfaced patellae .


There is no consensus regarding patellar resurfacing during primary TKA .


Current prospective studies fail to determine any differences in clinical outcome among patients after TKA with or without patellar resurfacing .


This randomized controlled trial has been designed to determine the effectiveness of patellar resurfacing during TKA in patients undergoing TKA who have clinical and radiological signs of tibiofemoral and patellofemoral OA , using a specific patellofemoral outcome measurement .


Symptom scoring for the assessment of allergen immunotherapy is associated with a substantial placebo effect .


To assess the ability of exhaled breath temperature ( EBT ) , a putative marker of airway inflammation , to evaluate objectively the efficacy of grass pollen sublingual immunotherapy in a proof-of-concept study .


This was a double-blinded , placebo-controlled clinical trial in @ subjects ( mean SD @ @ years old , @ men ) sensitized to grass pollen .


The objective measurements were EBT , spirometry , and periostin and high-sensitivity C-reactive protein in blood .


Overall discomfort scored on a visual analog scale was used as a proxy for subjective symptoms .


Evaluations were performed before , during , and after the grass pollen season .


Fifty-one subjects ( @ and @ in the active treatment and placebo groups , respectively ) were assessed before and during the pollen season .


The mean pre - vs in-season increase in EBT was significantly smaller ( by @ % ) in the active treatment than in the placebo group ( P = @ ) .


Of the other objective markers , only the blood periostin level increased significantly during the pollen season ( P = @ ) , but without intergroup differences .


Subjectively , the mean pre - vs in-season increase in the visual analog scale score was @ % smaller in the active treatment than in the placebo group , although this difference did not reach statistical significance ( P = @ ) .


These results suggest that the efficacy of grass pollen sublingual immunotherapy can be assessed by EBT , a putative quantitative measurement of airway inflammation , which is superior in its power to discriminate between active and placebo treatment than a subjective assessment of symptoms assessed on a visual analog scale .


Decreased movement ability , one of the hallmarks of Parkinson disease ( PD ) , may lead to inadequate physical activity ( PA ) and excessive time spent in sedentary behaviors-@ factors associated with an elevated risk for lifestyle-related diseases , poor management of PD , and premature death .


To identify the extent to which people with PD are physically active , a comprehensive characterization of PA in this population is needed .


The study objective was to describe levels and patterns of PA and sedentary behaviors in elderly people with PD .


This cross-sectional study involved a free-living setting and @ men and @ women ( mean age = @ years ) with mild to moderate idiopathic PD .


Time spent in PA and sedentary behaviors was assessed for @ week with accelerometers .


Mean daily step counts were @,@ ; participants spent @ minutes in sedentary behaviors , @ minutes in low-intensity activities , @ minutes in moderate-intensity lifestyle activities , and @ minutes in moderate - to vigorous-intensity ambulatory activities .


No differences were found between weekdays and weekend days .


Patterns were characterized by a rise in total PA in the morning , peaking between @ am and @ pm , and a gradual decline toward the late evening .


The proportion achieving @ minutes of moderate - to vigorous-intensity PA per week was @ % , and @ % achieved @,@ or more steps per day .


Nonrandomized selection of participants may limit the generalizability of the results .


Physical activity levels were generally low , in terms of both total volume and intensity , with only minor variations over the course of a day or between days .


These results emphasize the need to develop strategies to increase PA and reduce time spent in sedentary behaviors in elderly people with mild to moderate PD .


Chronic pancreatitis is a chronic inflammatory disorder characterized by progressive fibrosis of pancreatic tissue .


The principal symptom is chronic pain resulting in reduced quality of life and inability to work .


Short-term follow-up has shown that duodenum-preserving pancreatic head resections ( DPPHRs ) are superior in outcomes to pancreaticoduodenectomy .


Therefore , these organ-sparing procedures have gained wide acceptance .


This trial was conducted to compare patient outcomes @ years after treatment for chronic pancreatitis by means of the Beger or the Frey procedure .


Seventy-four patients suffering from chronic pancreatitis were randomly assigned to @ treatment groups ( Beger n = @ ) and Frey ( n = @ ) .


The perioperative courses in the randomized controlled trial and the @-year follow-up have been reported previously .


All participating patients were contacted with a standardized , validated questionnaire to evaluate long-term survival , quality of life , pain , and exocrine and endocrine function .


No significant differences between the @ groups in terms of quality of life , pain control , or other somatic parameters were detected after a median of @ years postoperatively .


Mortality was comparable after Beger and Frey procedures at @ % vs @ % , respectively , with postoperative survivals of @ @ years and @ @ years , respectively ( p = @ ) .


No statistically significant differences were found in rates of endocrine insufficiency ( Beger @ % vs Frey @ % ; p = @ ) or exocrine insufficiency ( Beger @ % vs Frey @ % ; p = @ ) .


Duodenum-preserving resections of the pancreatic head offered good and permanent pain relief and substantially increased quality of life in chronic pancreatitis .


Overall , a @-year long-term follow-up found comparable outcomes for the Beger and Frey procedures .


To evaluate the efficacy and safety of the dipeptidyl peptidase-@ inhibitor alogliptin plus metformin ( A+M ) initial combination therapy versus either as monotherapy in drug-nave T@DM patients .


This international , randomized , double-blind , placebo-controlled , @-week study involved T@DM patients with hyperglycaemia ( HbA@c @-@ @ % ) following diet/exercise therapy .


Patients ( N = @ ) received placebo , alogliptin ( A , @ mg BID or @mg QD ) , metformin ( M , @ or @mg BID ) or A+M ( @ / @ or @ / @mg BID ) ; placebo , A@ for secondary analyses only .


week@ changes from baseline in HbA@c ( primary ) , fasting plasma glucose ( FPG ) and @-h postprandial glucose ( PPG ) ; incidences of clinical response and hyperglycaemic rescue .


Week @ mean HbA@c reductions from baseline ( @ % ) were -@ and -@ % with A+M @ / @ and @ / @ versus -@ , -@ , and -@ % with A@ @ , M@ and M@ ( p < @ , A+M vs. component monotherapies ) .


FPG reductions were -@ and -@ mmol/L with @ / @ and @ / @ versus -@ , -@ and -@ mmol/L with A@ @ , M@ and M@ ( p < @ , A+M vs. component monotherapies ) .


Significantly more A+M - treated patients achieved HbA@c < @ % ( @-@ @ % vs. @-@ @ % with monotherapy ) , significantly fewer required hyperglycaemic rescue ( @-@ @ % vs. @-@ @ % with monotherapy ) .


A+M caused only mild/moderate hypoglycaemia ( @-@ @ % ) and weight loss ( @-@ @ kg ) .


Alogliptin plus metformin initial combination therapy was well tolerated yet more efficacious in controlling glycaemia in drug-nave T@DM patients than either as monotherapy .


To clinically and histopathologically evaluate the anti-inflammatory effect of @ % hyaluronan gel alone and with mechanical therapy on gingivitis .


The argyrophilic nucleolar organizer region staining technique was attempted to routinely determine its diagnostic and prognostic dependability for periodontal lesions .


In each of the @ gingivitis patients , the four quadrants were subjected to different treatments : scaling , scaling + topical hyaluronan gel , only topical hyaluronan gel , and topical + intrasulcular hyaluronan gel .


Clinical parameters were recorded at baseline , and on days @ , @ , and @ .


Biopsies were taken from each quadrant , inflammatory infiltrates were graded , and the argyrophilic nucleolar organizer region count was measured before and after treatment .


A significant reduction was seen in clinical parameters , inflammatory infiltrates , and the argyrophilic nucleolar organizer region count within the groups .


The effect of topical + intrasulcular gel was equivalent to scaling ( P > @ ) .


Topical + intrasulcular hyaluronan gel application demonstrated a better reduction than topical hyaluronan gel alone .


Hyaluronan gel is an effective topical agent for treating gingivitis , along with scaling and intrasulcular application .


The argyrophilic nucleolar organizer region count can be used as a histopathological indicator in cases of non-responsive gingivitis to assess the severity of gingival inflammation .


We aimed to assess the dyadic validity of the Decisional Conflict Scale ( DCS ) for assessing shared decision making in clinical consultations .


We applied dyadic criteria , which consider the patient and physician as an interactive dyad instead of as independent individuals , to identify common patient/physician measures of patient uncertainty .


Patients and their physicians , participating in a randomized clustered trial , completed separately an adapted version of the DCS with five subscales .


We performed factor analysis on the full DCS and each subscale independently .


We defined a measure as dyadic when measurement invariance across patients and physicians was supported .


We analyzed @ paired responses ( physicians with adults or with parents and children ) at study entry and @ at exit .


Factor analysis showed that the full DCS is not a valid dyadic measure .


However , independent analysis of each subscale showed measurement invariance for values clarity , support , and effective decision ( comparative fit index range , @-@ ; root mean square error of approximation range , @-@ @ ; and P-value > @ ) .


Application of our dyadic validation criterion indicated that the full DCS can not be considered a dyadic measure .


However , three of its subscales , values clarity , support and effective decision , are valid dyadic measures .


Research has shown that orthodontic patients are more likely to retain information presented in an audiovisual format .


However , there has been little research on the effectiveness of audiovisual information provided through different routes such as the Internet .


This parallel-group randomized controlled trial assessed whether provision of audiovisual information on the YouTube ( Google , San Bruno , Calif ) Web site to orthodontic patients undergoing fixed appliance treatment results in improved patient knowledge when compared with conventional methods of information provision .


The effects of sex and ethnicity were also investigated .


Participants were recruited from the Department of Orthodontics of the Eastman Dental Hospital , University College London Hospitals NHS Foundation Trust , United Kingdom .


The patients were @ years of age and over , with no history of orthodontic treatment , and patient and parental ( where appropriate ) consent were obtained .


The participants were randomized into control ( n = @ ) and intervention ( n = @ ) groups using a random number table ; there was stratification based on age group , with permuted blocks of @ patients .


Both groups were given routine verbal and written patient information related to fixed appliances , and the participants in the intervention group were sent @ e-mails over @ weeks requesting that they view a @-minute YouTube video containing similar information but in audiovisual format .


Patient knowledge was measured using identical questionnaires answered on the day of recruitment ( baseline ) and again @ to @ weeks later .


The researchers were unaware of group allocations when enrolling patients and scoring questionnaires .


Sixty participants ( @ % ) completed the study .


Those who completed the trial in the intervention group ( n = @ ) demonstrated significantly greater improvements in knowledge than did those in the control group ( n = @ ) , scoring , on average , almost @ point more ( @ % CI for the difference , @-@ @ ; P = @ ) on the final questionnaire .


Ethnicity had a statistically significant effect on improvement in knowledge , but sex did not .


No harm to any patient was noted during the trial .


Presenting audiovisual information through the YouTube Web site to orthodontic patients resulted in a significant improvement in patient knowledge .


Supplementation of verbal and written patient information with audiovisual information via the Internet is therefore worthy of consideration .


National Research and Ethics Service ( REC number @/LO/@ ) , United Kingdom .


The protocol was not published before trial commencement .


Gamithromycin is active in vitro against the bacterial agents most commonly associated with bronchopneumonia in older foals .


However , the clinical efficacy and safety of this drug have not been investigated .


Gamithromycin is effective for the treatment of bronchopneumonia in foals .


One hundred and twenty-one foals on a farm endemic for infections caused by Rhodococcus equi .


In a controlled , randomized , and double blinded clinical trial , foals with ultrasonographic evidence of pulmonary abscesses ( abscess score @-@ cm ) were randomly allocated in @ treatment groups : ( @ ) gamithromycin IM q@ days ( n = @ ) ; ( @ ) azithromycin with rifampin , PO q@h ( n = @ ) ; or ( @ ) no antimicrobial treatment ( controls ; n = @ ) .


Physical examination and thoracic ultrasonography were performed by individuals unaware of treatment group assignment .


Foals that worsened were removed from the study .


The proportion of foals that recovered without the need to be removed from the study was significantly higher for foals treated with gamithromycin ( @ of @ ) or azithromycin with rifampin ( @ of @ ) than for controls ( @ of @ ) .


Treatment with gamithromycin or with azithromycin-rifampin resulted in a significantly faster decrease in the clinical score and abscess score compared to the controls .


Adverse reactions characterized by colic ( n = @ ) and hind limb lameness ( n = @ ) were observed only in foals treated with gamithromycin .


Gamithromycin was noninferior to azithromycin with rifampin for the treatment of bronchopneumonia in the study population but had a higher frequency of adverse reactions .


Diabetes mellitus is a rising non-communicable disease in Malaysia .


Insulin therapy refusal is a great challenge for healthcare providers , as it results in delayed insulin initiation .


This study was conducted to determine the prevalence of insulin therapy refusal and its associated factors .


This cross sectional study was conducted at seven public health clinics in Kubang Pasu district , Malaysia , from March to October @ .


A newly developed and validated questionnaire was used and participants were selected via systematic random sampling .


Only patients diagnosed with type II diabetes mellitus ( T@DM ) and under the public health clinic care in Kubang Pasu were included in the study .


Multiple logistic regressions were used to study the association between insulin therapy refusal and its associated factors .


There were @ respondents and the response rate was @ % .


Among these @ patients with T@DM , @ % refused insulin therapy .


The most common reason given for refusal was a lack of confidence in insulin injection ( @ % ) .


Multiple logistic regression revealed that respondents who had secondary education were @ % less likely to refuse insulin therapy than those who had primary or no formal education ( p = @ , adjusted odds ratio -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @-@ @ ) .


There was also a significant inverse association between glycated haemoglobin ( HbA@c ) and insulin therapy refusal ( p = @ , adjusted OR = @ , @ % CI = @-@ @ ) .


Insulin therapy refusal is common in Kubang Pasu .


Education status and HbA@c should be taken into consideration when counselling patients on insulin therapy initiation .


The present study evaluated the effects of creatine monohydrate ( CrM ) consumption post-exercise on body composition and muscle strength in middle to older males following a @-week resistance training program .


In a double-blind , randomized trial , @ males aged between @ and @ years were randomly assigned to consume either CrM-carbohydrate ( CHO ) -LSB- @ g days ( -@ ) CrM + @ g days ( -@ ) CHO @ days , then @ g kg ( -@ ) CrM + @ g CHO on training days ( average dosage of ~ @ g ) -RSB- or placebo CHO ( @ g days ( -@ ) CHO @ days , then @ g CHO on training days ) while participating in a high intensity resistance training program -LSB- @ sets @ repetitions at @ % of @ repetition maximum ( @RM ) -RSB- , @ days weeks ( -@ ) for @ weeks .


Following the initial @-day `` loading '' phase , participants were instructed to ingest their supplement within @ min post-exercise .


Body composition and muscle strength measurements , blood collection and vastus lateralis muscle biopsy were completed at @ , @ , @ and @ weeks of the supplement and resistance training program .


A significant time effect was observed for @RM bench press ( p = @ ) , leg press ( p = @ ) , body mass ( p = @ ) , fat-free mass ( p = @ ) and total myofibrillar protein ( p = @ ) .


A trend for larger muscle fiber cross-sectional area in the type II fibers compared to type I fibers was observed following the @-week resistance training ( p = @ ) .


No supplement interaction effects were observed .


Post-exercise ingestion of creatine monohydrate does not provide greater enhancement of body composition and muscle strength compared to resistance training alone in middle to older males .


The purpose of routine alcohol screening is to identify patients who may benefit from brief intervention , but patients who also have alcohol and other substance use disorders ( AUD/SUD ) likely require more intensive interventions .


This study sought to determine the prevalence of clinically documented AUD/SUD among VA outpatients with unhealthy alcohol use identified by routine screening .


VA patients @-@ years who screened positive for unhealthy alcohol use ( AUDIT-C @ women ; @ men ) and were randomly selected for quality improvement standardized medical record review ( @/@ -@ / @ ) were included .


Gender-stratified prevalences of clinically documented AUD/SUD ( diagnosis of AUD , SUD , or alcohol-specific medical conditions , or VA specialty addictions treatment on the date of or @ days prior to screening ) were estimated and compared across AUDIT-C risk groups , and then repeated across groups further stratified by age .


Among @,@ eligible patients with unhealthy alcohol use , @ % ( n = @ ) women and @ % ( n = @,@ ) men had documented AUD/SUD ( p < @ ) .


The prevalence of AUD/SUD increased with increasing AUDIT-C risk , ranging from @ % ( @ % CI @-@ % ) to @ % ( @-@ % ) for women and @ % ( @-@ % ) to @ % ( @-@ % ) for men in the lowest and highest AUDIT-C risk groups , respectively .


Patterns were similar across age groups .


One-quarter of all patients with unhealthy alcohol use , and a majority of those with the highest alcohol screening scores , had clinically recognized AUD/SUD .


Healthcare systems implementing evidence-based alcohol-related care should be prepared to offer more intensive interventions and/or effective pharmacotherapies for these patients .


Iniparib is a novel anticancer agent initially considered a poly ( ADP-ribose ) polymerase ( PARP ) inhibitor , but subsequently shown to act via non-selective protein modification through cysteine adducts .


This randomized phase II study investigated the addition of iniparib to gemcitabine-cisplatin in metastatic non-small-cell lung cancer ( NSCLC ) patients .


Patients with histologically confirmed stage IV NSCLC were randomized @ : @ to receive gemcitabine ( @ mg/m ( @ ) , days @/@ ) and cisplatin ( @ mg/m ( @ ) , day @ ) with -LSB- gemcitabine/cisplatin/iniparib ( GCI ) -RSB- or without -LSB- gemcitabine/cisplatin ( GC ) -RSB- iniparib ( @ mg/kg , days @/@/@ / @ ) every @ weeks for six cycles .


The primary end point was the overall response rate ( ORR ) .


Secondary objectives included progression-free survival ( PFS ) , overall survival ( OS ) , and safety .


The study was not designed for formal efficacy comparison , the control arm being to benchmark results against the literature .


One hundred and nineteen patients were randomized ( @ GC and @ GCI ) .


More GCI patients were male ( @ % GCI and @ % GC ) and had PS @ ( @ % GCI and @ % GC ) .


The ORR was @ % -LSB- @ % confidence interval ( CI ) @ % -@ % -RSB- with GC versus @ % ( @ % CI @ % -@ % ) with GCI , which did not allow rejection of the null hypothesis ( ORR with GCI @ % ; P = @ ) .


Median PFS was @ ( @ % CI @-@ @ ) months with GC and @ ( @ % CI @-@ @ ) months with GCI ( hazard ratio @ , @ % CI @-@ @ ) .


Median OS was @ ( @ % CI @ to not reached ) months with GC , and @ ( @ % CI @-@ @ ) months with GCI ( hazard ratio @ , @ % CI @-@ @ ) .


More GCI patients received second-line treatment ( @ % GC and @ % GCI ) .


Toxicity was similar in the two arms .


Grade @-@ toxicities included asthenia ( @ % GC and @ % GCI ) , nausea ( @ % GC and @ % GCI ) , and decreased appetite ( @ % in each ) .


Addition of iniparib to GC did not improve ORR over GC alone .


The GCI safety profile was comparable to GC alone .


Imbalances in PS and gender distribution may have impacted study results regarding PFS and OS .


Polysorbate @ ( P@ ) , a nonionic detergent used to solubilize proteins , is used in both oral and injectable medications including vaccines .


Development studies with @-valent pneumococcal conjugate vaccine ( PCV@ ) showed that adding P@ resulted in a more robust manufacturing process .


Before adding P@ to the formulation of PCV@ , we investigated the immunogenicity and safety of PCV@ with and without P@ .


Phase @ , parallel-group , randomized , active-controlled , double-blind multicenter trial was conducted at @ sites in Poland .


Healthy infants were randomized ( @:@ ) to receive PCV@ + P@ or PCV@ without P@ given at ages @ , @ , @ and @ months concomitantly with DTaP-IPV-Hib at @ , @ and @ months ; hepatitis B at @ months and measles , mumps , and rubella at @ months .


Serotype-specific antipneumococcal immune responses were evaluated using antipolysaccharide capsular immunoglobulin ( Ig ) G responses and opsonophagocytic activity ( OPA ) assay .


Safety data were also collected .


The @ treatment groups were demographically similar .


Following the infant immunization series , anticapsular IgG antibody geometric mean concentrations and OPA geometric mean titers for each serotype were within @-fold between the @ groups .


Formal noninferiority criteria for comparison of proportion of responders ( subjects with IgG titers @ g/mL ) were met for @ of the @ serotypes .


Overall population responses were highly similar .


Anticapsular IgG responses were also within @-fold following the toddler dose .


Safety profiles were similar between the @ groups .


Addition of P@ to PCV@ did not adversely affect PCV@ immunogenicity or safety when compared with vaccine formulated without P@ .


We investigated with @HNMR-spectroscopy the effects of habitual fatty fish intake on serum lipiprotein profiles in persons with features of metabolic syndrome .


The participants ( n = @ ) were randomized into three diet intervention groups .


The groups were given different dietary instructions .


Increased intake of fatty fish had a significant ( p < @ ) increasing effect on the amount of large HDL-lipoprotein subclasses and their lipids .


Frequent intake of fatty fish may have beneficial effects on HDL-metabolism beyond that assumed to be related to its serum concentrations .


To assess , in a randomized , phase @ trial , the efficacy and safety of chemoradiotherapy with or without induction chemotherapy ( ICT ) of S@ and oxaliplatin for esophageal cancer .


Patients with stage II , III , or IVA esophageal cancer were randomly allocated to either @ cycles of ICT ( oxaliplatin @ mg/m ( @ ) on day @ and S@ at @ mg/m ( @ ) twice daily on days @-@ , every @ weeks ) followed by concurrent chemoradiotherapy ( CCRT ) ( @ Gy , @ Gy/d with oxaliplatin @ mg/m ( @ ) on days @ and @ and S@ @ mg/m ( @ ) twice daily , @ days per week during radiation therapy ) and esophagectomy ( arm A ) , or the same CCRT followed by esophagectomy without ICT ( arm B ) .


The primary endpoint was the pathologic complete response ( pCR ) rate .


A total of @ patients were randomized ( arm A/B , @/@ ) , @ of whom underwent esophagectomy ( arm A/B , @/@ ) .


The intention-to-treat pCR rate was @ % ( @ % confidence interval -LSB- CI -RSB- @-@ @ % ) in arm A and @ % ( @ % CI @ % to @ % ) in arm B. With a median follow-up duration of @ months , the @-year progression-free survival rate was @ % in arm A and @ % in arm B , whereas the @-year overall survival rate was @ % and @ % , respectively .


Grade @ or @ thrombocytopenia during CCRT was more common in arm A than in arm B ( @ % vs @ % ) .


The relative dose intensity of S@ ( @ % @ % vs @ % @ % , P = @ ) and oxaliplatin ( @ % @ % vs @ % @ % , P = @ ) during CCRT was lower in arm A compared with arm B. Three patients in arm A , compared with none in arm B , died within @ days after surgery .


Combination chemotherapy of S@ and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer .


However , we failed to show that the addition of ICT to the regimen can improve the pCR rate .


There is a growing interest for the use of probiotics for chronic constipation .


A recent randomized controlled trial ( RCT ) showed a positive effect of Lactobacillus reuteri ( L. reuteri ) on bowel movement frequency in infants with chronic constipation .


The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation .


A double-blind , placebo RCT was conducted in @ adults ( @M/@F , @ + / -@ years ) affected by functional constipation according to the Rome III criteria .


Patients were randomly assigned to receive a supplementation of L. reuteri ( DSM @ ) , or matching placebo for @ weeks .


The increase of bowel movements/week was the primary outcome , while the improvement of stool consistency was the secondary outcome .


At week @ , the mean increase in bowel movements/week was @ ( SD + / -@ , @ % CI :@ -@ ) in the L. reuteri group and @ ( SD + / -@ % CI :@ -@ ) in the placebo group ( p = @ ) .


At the end of the treatment , the mean bowel movements/week was @ + / -@ in the L. reuteri group and @ + / -@ in the placebo group .


There was a not significant difference in the stool consistency between the two groups .


L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children , even if it seems to have no effect on stool consistency .


The extent of heterogeneity in response to the psychopharmacological treatment of negative symptoms is unknown .


To examine the extent of heterogeneity in response to the treatment of predominantly negative symptoms of schizophrenia .


Data were analyzed from three clinical trials that compared placebo or amisulpride for up to @days .


Trial participants had predominantly negative symptoms of schizophrenia ( n = @ ) .


Heterogeneity of percentage reduction on the Scale for the Assessment of Negative Symptoms ( SANS ) was examined with trajectory-group based modeling followed by descriptive statistics and the prediction of trajectory group membership with logistic regression modeling .


Analyses were repeated separately for the placebo and amisulpride groups .


Trajectory group-based modeling identified groups of non - ( n = @ , @ % ) , gradual-moderate ( n = @ , @ % ) and rapid - ( n = @ , @ % ) responders .


At baseline compared to non-responders , rapid-responders had consistently significantly ( p < @ ) higher SANS total and subscale scores .


Percent SANS improvement at endpoint was greatest for the rapid-responders group , a finding that replicated stratifying by placebo and amisulpride treatment groups .


Similarly , in the total sample and stratifying by placebo and amisulpride groups , dropout was not significantly associated with trajectory group membership .


Trajectories of treatment response to the psychopharmacological medication of the negative symptoms of schizophrenia demonstrate substantial heterogeneity .


Approximately half of the patients included in our analysis showed little improvement , and the most severely ill at baseline responded the most .


Fetuin-A may mediate cross-talk between the liver and adipose tissue .


We studied the physiologic regulation of fetuin-A and explored its potential regulation by leptin .


Fetuin-A levels were measured in three interventional studies as well as in in vitro experiments .


Study @ : @ lean subjects received placebo or physiologic replacement-dose recombinant human leptin ( metreleptin ) following short term complete caloric deprivation to induce severe hypoleptinemia ; Study @ : @ women with relative leptin deficiency due to strenuous exercise or low weight received @ months of metreleptin ; Study @ : @ women with relative leptin deficiency were randomized to receive metreleptin or placebo over @ months .


In study @ human hepatoma Hep G@ cells were treated with leptin .


Fetuin-A mRNA expression and secretion were measured .


Complete caloric deprivation significantly decreased leptin but had no effect on fetuin-A levels .


Normalizing leptin levels with metreleptin in hypoleptinemic subjects had no effect on circulating fetuin-A levels .


Leptin treatment had no effect on fetuin-A mRNA expression and secretion in vitro .


Circulating fetuin-A levels are not affected by short and long-term energy deprivation .


Furthermore , both in vivo and in vitro experiments confirm that fetuin-A is not regulated by leptin .


Unexplained fatigue is often left untreated or treated with antidepressants .


This randomized , placebo-controlled , single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose ( FCM ) in iron-deficient , premenopausal women with symptomatic , unexplained fatigue .


Fatigued women ( Piper Fatigue Scale -LSB- PFS -RSB- score @ ) with iron deficiency ( ferritin < @ g/L and transferrin saturation < @ % , or ferritin < @ g/L ) and normal or borderline hemoglobin ( @ g/L ) were enrolled in @ sites in Austria , Germany , Sweden and Switzerland , blinded to the study drug and randomized ( computer-generated randomization sequence ) to a single FCM ( @ mg iron ) or saline ( placebo ) infusion .


Primary endpoint was the proportion of patients with reduced fatigue ( @ point decrease in PFS score from baseline to Day @ ) .


The full analysis included @ women ( FCM @ , placebo @ ) .


Fatigue was reduced in @ % ( FCM ) and @ % ( placebo ) of patients ( OR @ , @ % CI @-@ @ ; p = @ ) .


A @ % reduction of PFS score was achieved in @ % FCM - vs. @ % placebo-treated patients ( p < @ ) .


At Day @ , all FCM-treated patients had hemoglobin levels @ g/L ( vs. @ % at baseline ) ; with placebo , the proportion decreased from @ % to @ % .


Mental quality-of-life ( SF-@ ) and the cognitive function scores improved better with FCM .


` Power of attention ' improved better in FCM-treated patients with ferritin < @ g/L .


Treatment-emergent adverse events ( placebo @ , FCM @ ; most frequently headache , nasopharyngitis , pyrexia and nausea ) were mainly mild or moderate .


A single infusion of FCM improved fatigue , mental quality-of-life , cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin .


Although more side effects were reported compared to placebo , FCM can be an effective alternative in patients who can not tolerate or use oral iron , the common treatment of iron deficiency .


Overall , the results support the hypothesis that iron deficiency can affect women 's health , and a normal iron status should be maintained independent of hemoglobin levels .


This study compared wireless Contralateral Routing of Signals ( CROS ) hearing aid and bone-anchored hearing device ( BAHD ) in patients with single-sided deafness .


Eight adults with single-sided deafness previously implanted with a BAHD were given a @-week trial with a CROS hearing aid and tested in unaided and aided conditions .


Both devices were compared on head shadow effect reduction , speech perception measures in quiet and in noise , self-assessment questionnaires , and daily diaries .


Both the CROS and BAHD significantly reduced the head shadow effect .


QuickSIN scores were significantly better with noise presented to the poorer ear , as compared to the better ear , for the unaided condition , the BAHD , and the CROS .


Scores showed no significant differences between the CROS and BAHD with noise presented to the better ear , but scores with the CROS were significantly poorer than in the unaided condition with noise presented to the poorer ear .


There were no significant differences between BAHD and CROS for the ratings on the Bern Benefit in Single-Sided Deafness and Speech Spatial Qualities questionnaires .


Both devices were worn an average of @ hours per day .


Four participants preferred the CROS for sound quality ; three preferred the BAHD for comfort .


Comparisons of CROS and BAHD need to be re-evaluated as both technologies have evolved .


In our pilot study , both devices seem comparable , with the CROS avoiding the risks of surgery , and we recommend a trial of CROS in our center for first line treatment of single-sided deafness .


To evaluate the outcomes of the combination of red light or intense pulsed laser ( IPL ) with @-aminolevulinic acid ( ALA ) - mediated photodynamic therapy ( PDT ) in the treatment of photodamaged neck skin .


The anterior of the neck was divided into four @ cm @ cm sections and randomly assigned to red-light , red-light-PDT , IPL or IPL-PDT group .


ALA cream of @ % was applied to PDT regions for @h prior to light irradiation .


Treatment was repeated once .


The stratum corneum ( SC ) hydration , transepidermal water loss ( TEWL ) , L ( * ) , a ( * ) , b ( * ) values , melanin index ( MI ) , erythema index ( EI ) , skin elasticity and skin thickness were examined by a blinded investigator .


The function and volume of thyroid were also measured .


After red-light-PDT , IPL-PDT and IPL treatment , the appearance of photoaging lesion was improved .


The SC hydration , L ( * ) value , elasticity and thickness increased , whereas the TEWL and MI value decreased .


These changes in red-light-PDT and IPL-PDT group were more obvious than IPL group .


The a ( * ) and EI value increased in red-light-PDT group .


No significant change was noticed in red-light group .


Partial irradiation of the thyroid did not affect the function and volume of the thyroid .


IPL-PDT and red-light-PDT showed better rejuvenation effect than IPL or red light alone on the neck skin .


Disordered eating behavior and body dissatisfaction affect a large proportion of the Dutch population and account for severe psychological , physical and social morbidity .


Yet , the threshold for seeking professional care is still high .


In the Netherlands , only @ % of patients with bulimia nervosa and @ % of patients with anorexia nervosa are treated within the mental health care system .


Easily accessible and low-threshold interventions , therefore , are needed urgently .


The internet has great potential to offer such interventions .


The aim of this study is to determine whether a web-based treatment program for patients with eating disorders can improve eating disorder psychopathology among female patients with bulimia nervosa , binge eating disorder and eating disorders not otherwise specified .


This randomized controlled trial will compare the outcomes of an experimental treatment group to a waiting list control group .


In the web-based treatment program , participants will communicate personally and asynchronously with their therapists exclusively via the internet .


The first part of the program will focus on analyzing eating attitudes and behaviors .


In the second part of the program participants will learn how to change their attitudes and behaviors .


Participants assigned to the waiting list control group will receive no-reply email messages once every two weeks during the waiting period of @ weeks , after which they can start the program .