The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group .


To evaluate the effectiveness of a prefabricated appliance and compare it to the effectiveness of a stabilization appliance in patients with temporomandibular joint ( TMJ ) pain .


This randomized , controlled multicenter study comprised @ patients diagnosed with TMJ arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders .


The effectiveness of a prefabricated appliance ( Relax ) , worn by half of the patients ( referred to as the R group ) , was compared to the effectiveness of a stabilization appliance , worn by the other half of patients ( S group ) .


Treatment outcome was assessed according to the recommendations by the Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials ( IMMPACT ) on an intent-to-treat basis .


To analyze the differences between groups , the chi-square test and the Mann-Whitney U test were used , while the Friedman analysis of variance ( ANOVA ) on ranks was used for the analyses between baseline data and follow-up measurements , all with a significance level set at P < @ .


There were no differences between the groups at baseline .


A @ % reduction of pain intensity was reported by @ % of the R group and @ % of the S group at the @-week follow-up ; @ % and @ % , respectively , at the @-month follow-up ; and @ % in both groups at @ months .


At the @-month follow-up , pain intensity had decreased and physical function had improved in both groups ( P < @ and P < @ , respectively ) , without significant group differences .


Emotional function ( depression and nonspecific physical symptoms ) did not change .


Overall improvement of `` better '' to `` symptom-free '' was observed in @ % of the R group and @ % of the S group .


No side effects occurred .


The effectiveness of the prefabricated appliance seems to be similar to that of the stabilization appliance in alleviating TMJ pain .


Since the prefabricated appliance requires only one visit for construction , it is convenient for both the general practitioner and for the patient .


Low @-hydroxyvitamin D ( @ ( OH ) D ) has been associated with increased HIV mortality , but prospective studies assessing treatment outcomes after combination antiretroviral therapy ( cART ) initiation in resource-limited settings are lacking .


A case-cohort study ( N = @ ) was nested within a randomized cART trial of @ cART-naive adults in @ resource-limited settings and the United States .


The primary outcome ( WHO stage @/@ disease or death within @ weeks of cART initiation ) was met by @ cases , and @ and @ cases met secondary outcomes of virologic and immunologic failure .


We studied prevalence and risk factors for baseline low @ ( OH ) D ( < @ ng/mL ) and examined associated outcomes using proportional hazard models .


Low @ ( OH ) D prevalence was @ % and ranged from @ % in Brazil to @ % in Thailand .


Low @ ( OH ) D was associated with high body mass index ( BMI ) , winter/spring season , country-race group , and lower viral load .


Baseline low @ ( OH ) D was associated with increased risk of human immunodeficiency virus ( HIV ) progression and death ( adjusted hazard ratio ( aHR ) @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) and virologic failure ( aHR @ ; @ % CI , @-@ @ ) .


Low @ ( OH ) D is common in diverse HIV-infected populations and is an independent risk factor for clinical and virologic failure .


Studies examining the potential benefit of vitamin D supplementation among HIV patients initiating cART are warranted .


Domestic violence and abuse ( DVA ) are associated with an increased risk of mental illness , but we know little about the mental health of female DVA survivors seeking support from domestic violence services .


Baseline data on @ women enrolled in a randomized controlled trial of a psychological intervention for DVA survivors was analyzed .


We report prevalence of and associations between mental health status and severity of abuse at the time of recruitment .


We used logistic and normal regression models for binary and continuous outcomes , respectively .


Mental health measures used were : Clinical Outcomes in Routine Evaluation-Outcome Measure ( CORE-OM ) , Patient Health Questionnaire , Generalized Anxiety Disorder Assessment , and the Posttraumatic Diagnostic Scale ( PDS ) to measure posttraumatic stress disorder .


The Composite Abuse Scale ( CAS ) measured abuse .


Exposure to DVA was high , with a mean CAS score of @ ( SD @ ) .


The mean CORE-OM score was @ ( SD @ ) with @ % above the clinical threshold ( @ % confidence interval : @-@ % ) .


Depression and anxiety levels were high , with means close to clinical thresholds , and all respondents recorded PTSD scores above the clinical threshold .


Symptoms of mental illness increased stepwise with increasing severity of DVA .


Women who have survived breast cancer have hot flushes that are `` significantly more frequent , severe , distressing , and of greater duration '' than in other women .


We compared the efficacy and safety of stellate ganglion block and pregabalin for the relief of hot flushes in breast cancer survivors .


Forty patients who were breast cancer survivors and were suffering from hot flushes to the degree that they seeked for treatment were included in the study and randomly divided into two groups : group I : ( N = @ ) stellate ganglion block was done for the patients of this group ; and group II : ( N = @ ) in this group , the patients received @mg pregabalin twice daily .


In both groups self-completed daily hot flush diaries and monthly symptom questionnaires were obtained at baseline and for the following @ months .


Our results showed that group I ( stellate ganglion block ) had significant ( P < @ ) decline in the frequency of mild , moderate , very severe , and total hot flushes in comparison with group II ( pregabalin @mg twice daily ) throughout the @ months of follow up period .


The stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors .


The treatment of obesity is an increasing global health priority , yet few effective drug treatments are currently available .


The discovery of novel anti-obesity therapies could be assisted by the validation of experimental ( translational ) medicine models in healthy volunteers that assess efficacy and safety at an early stage of drug development .


The aim of this study was to examine the effects of the @-HT@C receptor agonist meta-chlorophenylpiperazine ( mCPP ) in an experimental medicine model assessing both appetite and mood .


Using a between-subjects , double-blind , placebo-controlled design , @ male and @ female participants were randomly assigned to either placebo , @ - or @-mg mCPP treatment groups .


Lunch was eaten from a Universal Eating Monitor ( UEM ) that measured eating rate , and the participants completed the P@vital Oxford Emotional Test Battery ( ETB ) and a series of appetite and mood ratings .


mCPP reduced appetite and , in women , enhanced measures of satiation .


The drug also enhanced memory for emotional material in the word recall and recognition memory tasks of the ETB .


The results provide new insight into the effects of mCPP on appetite , satiety and memory in humans .


In addition , our data provide an illustration of the value of measuring changes in appetite and mood in healthy volunteers to determine the potential efficacy and safety of novel anti-obesity drugs .


The long-term outcomes of transcatheter aortic valve replacement ( TAVR ) in inoperable patients with severe aortic stenosis remain unknown .


In the Placement of Aortic Transcatheter Valves ( PARTNER ) study , @ patients were randomly assigned to TAVR or standard therapy .


We report the @-year outcomes on these patients , and the pooled outcomes for all randomly assigned inoperable patients ( n = @ ) in PARTNER , as well , including the randomized portion of the continued access study ( n = @ ) .


The @-year mortality rate in the TAVR and standard therapy groups was @ % and @ % , respectively ( P < @ ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


In survivors , there was significant improvement in New York Heart Association functional class sustained at @ years .


The cumulative incidence of strokes at @-year follow-up was @ % in TAVR patients versus @ % in patients undergoing standard therapy ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) ; however , the composite of death or strokes was significantly lower after TAVR versus standard therapy ( @ % versus @ % , P < @ ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR .


Analysis of the @ pooled randomly assigned patients ( TAVR , n = @ ; standard therapy , n = @ ) demonstrated significant improvement in all-cause mortality and functional status during early and @-year follow-up .


The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial .


TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up .


However , high residual mortality , even in successfully treated TAVR patients , highlights the need for more strategic patient selection .


Subjective clinical improvement does not always go hand-in-hand with right ventricular ( RV ) reverse remodeling after surgery for isolated severe tricuspid regurgitation ( TR ) .


This study aimed to evaluate the level of agreement between clinical improvement and echocardiographic RV reverse remodeling , and determine the relative prognostic powers of these @ factors in terms of long-term prognosis for patients with isolated TR surgery .


Sixty-one consecutive patients ( @ years ) were included .


During a median follow up of @ months ( IQR , @ months ) , a composite endpoint including death and admission for right heart failure was investigated .


Extents of reductions in RV end-systolic area ( RV-ESA ) and subjective clinical improvement at @ months were examined .


There were @ deaths and @ admissions for right heart failure .


A reduction in RV-ESA of > @ % effectively predicted event-free survival , with a sensitivity of @ % and a specificity of @ % ( AUC @ , P = @ ) .


With this cut-off , the agreement between a clinical and echocardiographic response was only @ % ( @ patients ) .


On Cox regression analysis , RV-ESA change emerged as the only independent predictor of event-free survival , whereas subjective clinical improvement did not .


A discrepancy between subjective and echocardiographic improvement at @ months after isolated TR surgery was observed in @ % of the patients .


Echocardiographic RV reverse remodeling , but not subjective clinical amelioration , was a strong prognosticator after surgery .


The effects of acute continuous positive airway pressure therapy on left ventricular diastolic function and functional capacity in patients with compensated systolic heart failure remain unclear .


This randomized , double-blind , placebo-controlled clinical trial included @ patients with heart failure and a left ventricular ejection fraction < @ who were in functional classes I-III according to the New York Heart Association criteria .


Twenty-three patients were assigned to continuous positive airway pressure therapy ( @ cmH@O ) , while @ patients received placebo with null pressure for @ minutes .


All patients underwent a @-minute walk test ( @MWT ) and Doppler echocardiography before and immediately after intervention .


Clinicaltrials.gov : NCT@ .


The groups had similar clinical and echocardiographic baseline variables .


Variation in the diastolic function index ( e ' ) after intervention was associated with differences in the distance walked in both groups .


However , in the continuous positive airway pressure group , this difference was greater ( continuous positive airway pressure group : @MWT = @ +@ e ' , p = @ ; sham group : @MWT = @ +@ e ' ; p = @ ) .


There was a statistically significant interaction between e ' index variation and continuous positive airway pressure for the improvement of functional capacity ( p = @ ) .


Continuous positive airway pressure does not acurately change the echocardiographic indexes of left ventricle systolic or diastolic function in patients with compensated systolic heart failure .


However , @-minute continuous positive airway pressure therapy appears to have an effect on left ventricular diastolic function by increasing functional capacity .


To explore if cognitive impairment in relapsing-remitting multiple sclerosis ( RRMS ) is associated with abnormal neural function and if there is evidence of neural compensatory mechanisms .


Seventy-two RRMS patients and @ healthy control subjects were included in a cross-sectional study .


Event-related brain potential ( P@ ) and response time ( RT ) were recorded with visual and auditory choice reaction tasks .


Cognitive function was evaluated with an @ item test battery .


Patients had a decrease in cognitive function ( p < @ for global score ) and increased visual P@ amplitude frontally .


P@ amplitude was normal in other brain areas and RT was normal .


P@ latency was normal except for an increase in auditory latency occipitally .


Cognitive performance correlated positively with parietal P@ amplitude in patients but not in controls .


Cognition had stronger correlation ( negative ) with RT in patients than in controls .


Patients with low P@ amplitude and long RT were more often cognitively impaired .


This indicates that general factors such as signal amplitude and speed are limiting for cognitive function in RRMS patients .


The increase in frontal P@ amplitude may be a compensatory effect .


Our findings suggest that high amplitude and fast speed may be protective against cognitive impairment .


To investigate the sedative and clinical effects of the pharmacopuncture with xylazine , compared to the conventional dose of a intramuscular injection in dogs .


Twelve dogs were randomly distributed in two groups of six animals and treated as follows : control group ( X-IM ) : @mg kg ( -@ ) of xylazine given intramuscularly ( IM ) ; pharmacopuncture group ( X-Yintang ) : @ mg kg ( -@ ) of xylazine diluted to @ mL of saline injected into the Yin Tang acupoint .


Heart rate , cardiac rhythm ( ECG ) , systolic arterial blood pressure ( SABP ) , respiratory rate ( RR ) , rectal temperature ( RT ) , blood glucose concentration , degree of sedation and adverse effects were evaluated .


Sedative effect was observed in both groups .


The degree of sedation was greater in X-IM only at @ min when compared with X-Yintang group .


Cardiovascular established was observed in X-Yintang group , while marked reduction in the HR and increased incidence of ECG abnormalities were detected in X-IM .


In both treatment groups , minimal changes were observed in relation to SABP , RR , RT and blood glucose .


High incidence ( @ % ) of vomiting was observed in X-IM , while this adverse effect was absent in X-Yintang .


Pharmacopuncture with xylazine induced clinically relevant sedative effects in dogs , with the advantage of reduction of undesirable side effects associated with @-agonists , including bradycardia , cardiac arrhythmias , and emesis .


Poor adherence to inhaled corticosteroids ( ICS ) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents .


This trial tested whether peer support group meetings and peer asthma messages delivered via mp@ players improved adherence to ICS .


Low-income African American and/or Hispanic adolescents , ages @-@ years old , with persistent asthma , and poor ( @ % ) adherence to prescription ICS during the @-week run-in were randomized to intervention or attention control groups ( ATG ) for the @-week treatment .


During treatment , the intervention arm subjects participated in weekly coping peer group support sessions and received mp@ peer-recorded asthma messages that promoted adherence .


The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp@ physician-recorded asthma messages .


Adherence was measured by using self-report and the Doser CT , an electronic dose counter .


The primary outcome was the difference in adherence at @ weeks between the @ arms .


Thirty-four subjects were randomized to each arm .


At @ weeks , no statistical difference in objectively measured adherence could be detected between the @ arms when adjusting for baseline adherence ( P = @ ) .


Adherence declined in both groups over the course of the active treatment period .


In both study arms , self-reported adherence by participants was significantly higher than their objectively measured adherence at week @ ( P < @ ) .


Improving medication adherence in longitudinal studies is challenging .


Peer support and mp@-delivered peer asthma messages may not be of sufficient dose to improve outcomes .


Recent studies have demonstrated higher-quality chest compressions ( CCs ) following a @ s ultra-brief video ( UBV ) on compression-only CPR ( CO-CPR ) .


However , the effectiveness of UBVs as a CPR-teaching tool for lay bystanders in public venues remains unknown .


Determine whether an UBV is effective in teaching laypersons CO-CPR in a public setting and if viewing leads to superior responsiveness and CPR skills .


Adult lay bystanders were enrolled in a public shopping mall and randomized to : ( @ ) Control ( CTR ) : sat idle for @ s ; ( @ ) UBV : watched a @ s UBV on CO-CPR .


Subjects were read a scenario detailing a sudden collapse in the mall and asked to do what they `` thought was best '' on a mannequin .


Performance measures were recorded for @ min : responsiveness ( time to call @ and first CCs ) and CPR quality -LSB- CC depth , rate , hands-off interval ( time without CC after first CC ) -RSB- .


One hundred subjects were enrolled .


Demographics were similar between groups .


UBV subjects called @ more frequently ( percent difference : @ % ) and initiated CCs sooner in the arrest scenario ( median difference ( MD ) : @ s ) .


UBV cohort had increased CC rate ( MD : @ cpm ) and decreased hands-off interval ( MD : @ s ) .


There was no difference in CC depth .


Bystanders with UBV training in a shopping mall had significantly improved responsiveness , CC rate , and decreased hands-off interval .


Given the short length of training , UBV may have potential as a ubiquitous intervention for public venues to help improve bystander reaction to arrest and CO-CPR performance .


To explore the eradication efficacies of triple versus quadruple furazolidone-based regimens for Helicobacter pylori ( H. pylori ) infection .


A total of @ outpatients with H. pylori infection were enrolled from June to December @ .


There were @ males and @ females with an average age of ( @ @ ) years .


A diagnosis of duodenal ulcer was made according to their endoscopic examination results .


They were randomly assigned into @ treatment groups : @-day triple ( n = @ ) and @-day triple ( n = @ ) , rabeprazole @ mg , amoxicillin @ @ mg and furazolidone @ mg twice daily for @ and @ days respectively .


@-day quadruple ( n = @ ) and @-day quadruple ( n = @ ) , rabeprazole @ mg , bismuth @ mg , amoxicillin @ @ mg and furazolidone @ mg twice daily for @ and @ days respectively.H .


pylori status was re-assessed with ( @ ) C-urea breath test after @-week therapy .


Among them , @ cases completed the study .


According to the analysis of intention-to-treat ( ITT ) , the H. pylori eradication rates were @ % ( @/@ ) in @-day triple , @ % ( @/@ ) in @-day triple , @ % ( @/@ ) in @-day quadruple and @ % ( @/@ ) in @-day quadruple groups .


No significant deviation existed among all groups ( P > @ ) .


According the per-protocol ( PP ) analysis , H. pylori eradication rates were @ % ( @/@ ) in @-day triple , @ % ( @/@ ) in @-day triple , @ % ( @/@ ) in @-day quadruple and @ % ( @/@ ) in @-day quadruple groups .


Significant deviation existed among all groups ( P = @ ) .


The H. pylori eradication rate in @-day quadruple group was significantly higher than that in @-day triple group ( P = @ ) .


The total adverse reaction rate was @ % ( @/@ ) .


No significant difference existed among all groups ( P > @ ) .


Quadruple treatments provide higher H. pylori eradication rates than triple therapies .


A @-day treatment may improve H. pylori eradication rate .


And @-day quadruple regimen with furazolidone and bismuth may be effective for H. pylori infection .


Prior studies show that adaptive servoventilation ( ASV ) is initially more effective than continuous positive airway pressure ( CPAP ) for patients with complex sleep apnea syndrome ( CompSAS ) , but choosing therapies has been controversial because residual central breathing events may resolve over time in many patients receiving chronic CPAP therapy .


We conducted a multicenter , randomized , prospective trial comparing clinical and polysomnographic outcomes over prolonged treatment of patients with CompSAS , with CPAP versus ASV .


Qualifying participants meeting criteria for CompSAS were randomized to optimized CPAP or ASV treatment .


Clinical and polysomnographic data were obtained at baseline and after @ days of therapy .


We randomized @ participants ( @ to each treatment ) .


At baseline , the diagnostic apnea-hypopnea index ( AHI ) was @ @ ( central apnea index -LSB- CAI -RSB- = @ @ ) and best CPAP AHI was @ @ ( CAI @ @ ) .


After second-night treatment titration , the AHI was @ @ ( CAI = @ @ ) on ASV and @ @ ( CAI = @ @ ) on CPAP ( P @ ) .


At @ days , the ASV versus CPAP AHI was @ @ versus @ @ ( P = @ ) and CAI was @ @ versus @ @ ( P < @ ) , respectively .


In the intention-to-treat analysis , success ( AHI < @ ) at @ days of therapy was achieved in @ % versus @ % of participants treated with ASV and CPAP , respectively ( P = @ ) .


Compliance and changes in Epworth Sleepiness Scale and Sleep Apnea Quality of Life Index were not significantly different between treatment groups .


Adaptive servoventilation ( ASV ) was more reliably effective than CPAP in relieving complex sleep apnea syndrome .


While two thirds of participants experienced success with CPAP , approximately @ % experienced success with ASV .


Because both methods produced similar symptomatic changes , it is unclear if this polysomnographic effectiveness may translate into other desired outcomes .


Clinicaltrials.Gov NCT@ .


Carpal tunnel syndrome ( CTS ) is one of the commonest peripheral neuropathies which effects mainly middle aged women .


Different techniques are being tried to decrease the postoperative pain in patients operated for CTS .


The objective of this study was to compare effectiveness of local injection of steroid and mini incision technique in the treatment of carpal tunnel syndrome .


This randomized control trial was conducted at department of Orthopedics and department of Neurosurgery , Ayub Teaching Hospital , Abbottabad from Aug @ to Feb @ .


A total of @ patients of CTS were randomly allocated to either of the two groups @ Patient in Group A were subjected to local steroid injection and the same number of patient in Group B underwent mini incision technique .


All patients of were advised to report to the OPD after one month to determine intervention effectiveness in terms of improvement in at least one grade of pain .


In this study mean age of the patients was @ + / - @ years .


Female gender was in dominance with @ ( @ % ) cases .


In this study we compared the effectiveness of local steroid injection and mini incision technique in the treatment of carpel tunnel syndrome .


We found out that the steroid injection was effective in @ % cases while mini incision technique was effective in @ % cases .


The difference being statistically insignificant with a p-value of @ .


The difference in pain after @ month of the intervention was not statistically significant .


The assessment of myocardial fatty acid metabolism impairment by single-photon emission computed tomography ( SPECT ) using ( @ ) I -- methyliodophenyl-pentadecanoic acid ( BMIPP ) might predict the risk of cardiac death in hemodialysis patients .


We investigated the potential of oral nicorandil to improve myocardial fatty acid metabolism after percutaneous coronary intervention ( PCI ) in this population .


We evaluated @ hemodialysis patients who had obtained coronary revascularization by PCI ( @ men and @ women , @ @ years ) .


Participants for the analysis were randomly assigned to either the nicorandil ( n = @ ) or control group ( n = @ ) .


BMIPP SPECT was performed every year after coronary revascularization by PCI .


Uptake on SPECT was graded in @ segments on a @-point scale ( @ , normal ; @ , absent ) and assessed as BMIPP summed scores ( SS ) .


The incidence of cardiac death was lower ( p = @ ) in the nicorandil group ( @/@ , @ % ) than in the control group ( @/@ , @ % ) during a mean follow-up of @ @ years .


BMIPP SS reduction rates improved in the nicorandil group compared with the control group from @ years of administration .


In Kaplan-Meier analyses , free survival rate of cardiac death was higher in patients with a @ % BMIPP SS reduction rate as compared with those with a < @ % BMIPP SS reduction rate ( p = @ ) .


In multiple logistic analysis , oral administration of nicorandil was associated with @ % reduction rates of BMIPP SS ( odds ratio @ , p = @ ) .


Long-term oral administration of nicorandil may improve impaired myocardial fatty acid metabolism after coronary revascularization by PCI in hemodialysis patients .


The immunogenicity and safety of the investigational diphtheria , tetanus , acellular pertussis , hepatitis B , poliomyelitis , Haemophilus influenzae type b ( Hib ) and meningococcal serogroup C ( MenC ) heptavalent combination vaccine were compared with those of licensed control vaccines .


In this open , phase II , randomized study ( NCT@ ) , @ infants from Germany , France and Canada received the heptavalent vaccine ( Hepta group ) or hexavalent and monovalent MenC control vaccines ( HexaMenC group ) co-administered with a @-valent pneumococcal conjugate vaccine at @ , @ and @ months of age .


Immunogenicity was measured @ month after the second primary dose , and before and @ month after the booster dose .


Safety and reactogenicity were also evaluated .


Non-inferiority of immune responses to MenC and Hib induced by @-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated .


In exploratory analyses , postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower ( @ vs. @ ; @ vs. @ ) and antibody geometric mean concentrations against Hib higher ( @ vs. @ g/mL ; @ vs. @ g/mL ) in the Hepta versus the HexaMenC group .


The heptavalent and control vaccines were immunogenic to all other antigens , although immune responses to poliovirus were lower than expected in both groups .


No differences in safety and reactogenicity profiles were detected between groups .


The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines .


Both vaccination regimens , when administered at @ , @ and @ months of age , had comparable safety profiles and were immunogenic to all antigens , with lower-than-expected responses to poliomyelitis .


The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) .


The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials .


Analyses were carried out in the intention-to-treat population , using non-parametric and parametric statistical methods .


Overall , @ % ( @/@ ) of EINSTEIN DVT patients and @ % ( @/@ ) of EINSTEIN PE patients were admitted to hospital .


The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was @ % compared with @ % for enoxaparin/vitamin K antagonist ( VKA ) in patients with DVT .


For patients with PE , the corresponding values were @ % and @ % .


Stays of @-@ days were observed in @ % of rivaroxaban-treated patients compared with @ % of enoxaparin/VKA-treated patients for DVT .


For patients with PE , these values were @ % and @ % in the rivaroxaban and enoxaparin/VKA groups , respectively .


Overall , length of stay was significantly shorter in the rivaroxaban group , compared with the enoxaparin/VKA group across all analyses performed ( p < @ ) .


Across regions , the observed admission rates and length of stay duration varied greatly : Asia had the longest overall hospitalization rates , whereas the lowest rates were reported in North America , Australia and New Zealand .


Nevertheless , a consistent trend was observed : length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than , or at least similar to , patients receiving enoxaparin/VKA .


A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients , and provides effective and well tolerated treatment .


The studies shared an open-label design that allowed comparison of initial hospitalization , but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management .


Identification of cancer or inflammatory bowel disease in the intestinal tract by PET/computed tomography ( CT ) imaging can be hampered by physiological uptake of F-fluorodeoxyglucose ( F-FDG ) in the normal colon .


Previous work has localized this F-FDG uptake to the intestinal lumen , predominantly occupied by bacteria .


We sought to determine whether pretreatment with an antibiotic could reduce F-FDG uptake in the healthy colon .


Thirty patients undergoing restaging PET/CT for nongastrointestinal lymphoma were randomly selected to receive rifaximin @ mg twice daily for @ days before their scan ( post-rifaximin ) .


Their PET/CT images were compared with those from their prior study ( pre-rifaximin ) .


Cecal maximum standard uptake value ( SUVmax ) and overall colonic F-FDG uptake were compared between scans .


All PET/CT images were blindly scored by a radiologist .


The same comparison of sequential scans was also undertaken in @ patients who did not receive antibiotics .


Thirty post-rifaximin scans were compared with @ pre-rifaximin scans in the same patients .


SUVmax in the cecum was significantly lower in the patient 's post-rifaximin scans than in their pre-rifaximin scans ( P = @ ) .


The percentage of scans with greater than grade @ colonic F-FDG uptake was significantly lower in the post-rifaximin scans than in the pre-rifaximin scans ( P < @ ) .


In contrast , there was no significant difference in the paired sequential scans from control patients , nor a reduction in the percentage of scans with greater than grade @ colonic F-FDG uptake .


This pilot study shows that treatment with rifaximin for @ days before PET/CT scanning can significantly reduce physiological F-FDG uptake in the normal colonic lumen .


Bioequivalence and comparability studies are necessary for changing formulations of large-molecule drugs , such as antibody drugs and protein products , and in the development of their biosimilars .


This study is the first application of modeling and simulation ( M&S ) in the design of bioequivalence and comparability studies of erythropoietin as an example of a large-molecule drug .


A novel population pharmacokinetic and pharmacodynamic ( PPK/PD ) model was developed for erythropoietin .


Based on this PPK/PD model , the probabilities of success of bioequivalence and comparability studies were simulated with various numbers of subjects and samples .


The simulation indicated that the minimum numbers of subjects and samples required to satisfy the criteria for bioequivalence and comparability studies were as follows : fewest for the area under the serum concentration-time curve , more for the area under the efficacy-time curve , and most for the maximum serum concentration of erythropoietin .


These results suggested that M&S could be successfully applied in the design of bioequivalence and comparability studies of large-molecule drugs .


A previous multicenter clinical trial of a needle-based fractional radiofrequency ( FRF ) treatment for facial and neck rhytides and laxity counterintuitively demonstrated a mean target temperature and treatment duration of @ C and @ seconds for subjects with lesser improvement and @ C and @ seconds for greater improvement .


To determine optimal temperature and duration settings for maximal clinical results in rhytides and laxity from a single FRF treatment of the face and neck .


A randomized , blinded , @-arm clinical evaluation of FRF at a series of temperatures from @-@ C to @ C. Three blinded plastic surgeons and dermatologists scored rhytides using the Fitzpatrick Wrinkle Assessment Scale and laxity using the Alexiades Laxity Assessment Scale at @ , @ , and @ months .


Blinded grading showed optimal improvement at @ C and @ seconds and decreased efficacy below @ C , with mean rhytide reductions of @ , @ , and @ % and mean laxity reductions of @ , @ , and @ % in Arms @ ( @ C ) , @ ( @ C ) , and @ ( @ C-@ C ) , respectively .


A @ % response rate was observed for all subjects treated at @ C to @ C target temperature .


The optimal target dermal temperature for facial and neck rhytide and laxity treatment is @ C and duration of @ to @ seconds with a @ % response rate after a single FRF treatment .


To reduce the spread of antibiotic resistance , there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI .


This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries .


The aim was to understand how the interventions were implemented and to examine effects of the interventions on general practitioners ' ( GPs ' ) and patients ' attitudes .


GPs were cluster randomised to one of three intervention groups or a control group .


The intervention groups received web-based training in either use of the C-reactive protein ( CRP ) test , communication skills and use of a patient booklet , or training in both .


GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Questionnaire .


Effects of the interventions on patients were assessed by a post-intervention questionnaire assessing patient enablement , satisfaction with the consultation , and beliefs about the risks and need for antibiotics .


GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training , and felt that taking part had helped them to reduce prescribing .


All GPs perceived reducing prescribing as more important and less risky following the intervention , and GPs in the communication groups reported increased confidence to reduce prescribing .


Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful .


Our findings suggest that the interventions should be broadly acceptable to both GPs and patients , as well as feasible to roll out more widely across Europe .


There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term , such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them .


Given the positive effects of the booklet on patient beliefs and attitudes , it seems logical to extend the use of the patient booklet to all patients .


Durable post-treatment response is uncommon in chronic hepatitis B ( CHB ) patients on nucleos ( t ) ide analogue therapy .


Response , response predictors and safety were assessed in patients who switched from long-term entecavir ( ETV ) to peginterferon alfa-@a .


Hepatitis B e antigen ( HBeAg ) - positive CHB patients who had received ETV for @-@ months , with HBeAg < @ PEIU/ml and HBV DNA @ copies/ml , were randomised @:@ to receive peginterferon alfa-@a @ g/week or ETV @ mg/day for @ weeks .


The primary endpoint was HBeAg seroconversion at week @ ( ClinicalTrials.gov : NCT@ ) .


@ patients were randomised ; @ received @ study drug dose .


Five patients who were anti-HBe-positive at baseline were excluded from the modified intention-to-treat population ( peginterferon alfa-@a , n = @ ; ETV , n = @ ) .


Patients who switched to peginterferon alfa-@a achieved higher week @ HBeAg seroconversion rates vs. those who continued ETV ( @ % vs. @ % ; p = @ ) .


Only patients receiving peginterferon alfa-@a achieved HBsAg loss ( @ % ) .


Among peginterferon alfa-@a-treated patients with HBeAg loss and HBsAg < @ IU/ml at randomisation , @ % and @ % achieved HBeAg seroconversion and HBsAg loss , respectively .


Early on-treatment HBsAg decline predicted response at week @ ; highest rates were observed in patients with week @ HBsAg < @ IU/ml ( HBeAg seroconversion , @ % ; HBsAg loss , @ % ) .


Alanine aminotransferase elevations were not associated with viral rebound ( n = @ ) .


Peginterferon alfa-@a was well-tolerated .


For patients who achieve virological suppression with ETV , switching to a finite course of peginterferon alfa-@a significantly increases rates of HBeAg seroconversion and HBsAg loss .


A response-guided approach may identify patients with the greatest chance of success .


To estimate effect sizes for a trial to compare preventable pulmonary complications ( PPCs ) , turning-related adverse events , mechanical ventilation duration , intensive care unit ( ICU ) length of stay , and ICU mortality between patients randomized to @-hourly manual or continuous automated lateral rotation .


Randomized controlled trial pilot study with @ patients selected randomly from eligible medical-surgical ICU patients from @ tertiary hospitals and assigned randomly to the manual-turn or automated-turn protocol for up to @ consecutive days .


A radiologist blinded to group and site assessed serial chest radiographs for PPCs .


Repeated-measures analysis with linear mixed models was used to estimate change in PPC score , and Wilcoxon rank sum or Fisher exact test was used to compare group differences in the secondary outcomes .


Of @ patients enrolled , @ ( @ % ) completed the study .


Data from @ patients , @ manual turn and @ automated turn , were analyzed .


Between-group differences in PPC incidence ( @ % overall ) , change in PPC score ( = @ , manual turn and = -@ , automated turn ) , and secondary outcomes were not significant ( P > @ ) .


Standardized effect sizes were small to moderate for the outcome variables .


A sample size of @ patients would be needed to detect statistically significant between-group differences in PPC over time .


The incidence of PPCs in adult patients receiving mechanical ventilation in a medical-surgical ICU was high .


Automated turning decreased PPCs with time but had little effect on secondary outcomes .


Safety outcomes were not substantially different between groups .


A modest efficacy effect supported reduced PPCs with automated turning to the lateral position .


There are so many studies associating blood pressure in children and adolescents with body fatness i.e. stating that high body fat is associated with high blood pressure in children and adolescents .


The purpose of this study was to determine that which portion of the body mass index , fat or fat free mass index is more influencing the blood pressure in Gujarati Indian adolescents .


@ schoolchildren of @-@ years of both genders were chosen for this study .


The body fat percentage and blood pressure were measured and on the basis of body mass and fat mass , fat free mass index and various other indices were calculated .


The association of fat mass index and fat free mass index with blood pressure was computed using correlations .


The relationship of BMI with mean blood pressure of boys ( R = @ ) was more strong than that in girls ( R = @ ) .


The blood pressure was having more strong positive correlation with lean body mass index than that with fat mass index in all subjects ( R = @ versus R = @ ) , boys ( R = @ versus R = @ ) , & girls ( R = @ versus R = -@ ) .


Fat free mass index has more strong association with blood pressure than fat mass index in the adolescent population irrespective of gender .


However as far as prevention of hypertension is concerned , reducing body fat ( rather than only body weight ) may remain an important measure to prevent hypertension as body fat mass is reducible while lean body mass may not be reducible and , in long term , obesity itself can lead to hypertension by various mechanisms .


Forming ` habit ' - defined as a learned process that generates automatic responses to contextual cues - has been suggested as a mechanism for behaviour maintenance , but few studies have applied habit theory to behaviour change .


This study used process evaluation data , taken from a randomised controlled trial of a healthy child-feeding intervention for parents previously shown to be effective , to explore the applicability to dietary behaviour change of predictions and recommendations drawn from habit theory .


The intervention supported parents in pursuing child-feeding habit goals in three domains ( giving fruit and vegetables , water , healthy snacks ) , over four fortnightly home visits .


We explored whether ( a ) the habit-formation model was acceptable to participants , ( b ) better-specified habit-formation goals yielded greater habit gains , and ( c ) habit gains were sustained ( d ) even when subsequent , new habit goals were pursued .


Qualitative and quantitative data were taken from @ parents randomised to the intervention arm , and so analyses presented here used a pre-post intervention design .


Thematic analysis of post-intervention qualitative interviews evaluated acceptability , and self-reported habit goals were content-analysed .


ANOVAs explored changes in habit strength , recorded at home visits and one - and two-month follow-ups , across time and goals .


Participants understood and engaged positively with the habit-formation approach .


Although many seemingly poorly-specified habit goals were set , goal characteristics had minimal impact on habit strength , which were achieved within two weeks for all behaviours ( p 's < @ ) , and were maintained or had increased further by the final follow-up .


The habit-formation model appears to be an acceptable and fruitful basis for dietary behaviour change .


N-acetyltransferase @ ( NAT@ ) is involved in the metabolism of various environmental substances , both with and without carcinogenic potential .


Alcoholic and nonalcoholic caffeine-rich beverages may be associated with markers of inflammation .


Systemic lupus erythematosus ( SLE ) is a chronic , multifaceted inflammatory disease .


We investigated the effects of alcoholic and nonalcoholic caffeine-rich beverages on risk of SLE and determined whether the effects were modified by NAT@ status .


The NAT@ polymorphism was genotyped in @ SLE cases and @ healthy controls , all women and Japanese .


We assessed effect modification by testing an interaction term for the NAT@ polymorphism and consumption of beverages .


Consumption of black tea ( odds ratio -LSB- OR -RSB- @ , @ % confidence interval -LSB- @ % CI -RSB- @-@ @ ) and coffee ( OR @ , @ % CI @-@ @ ) , but not green tea , was associated with an increased risk of SLE , while alcohol use ( OR @ , @ % CI @-@ @ ) was associated with a decreased risk of SLE .


There were significant interactions between the NAT@ polymorphism and either alcohol use ( Pinteraction = @ ) or consumption of black tea ( Pinteraction = @ ) .


The NAT@ polymorphism significantly modified the effects of alcohol use and black tea consumption on SLE , emphasizing the importance of incorporating genetic and metabolic information in studies on management of SLE .


Additional studies are warranted to confirm the findings suggested in this study .


To examine the effects of @ weeks of periodized resistance training ( RT ) with and without combined creatine and whey protein supplementation on changes in body composition , muscular strength , and functional performance .


Twenty-two male volunteers ( @ @ years ) were randomly assigned to one of three groups : RT plus supplementation ( RTS , n = @ ) ; RT only ( RT , n = @ ) ; or control ( C , n = @ ) .


RTS consumed @ g/kg/day of creatine for @ days followed by @ g/kg/day .


RTS also consumed one @ g liquid protein ready-to-drink daily .


RT and RTS trained @ days/week .


Following @ weeks of training , there were no significant differences in the main measured outcome variables between RT and RTS .


RTS increased relative ( % change ) lean body mass ( LBM , @ @ % ) compared with C ( p = @ ) .


Compared to baseline , RT increased LBM at week @ ( @ @ to @ @ kg ; p < @ ) , and decreased fat mass ( @ @ to @ @ kg ; p = @ ) and percentage body fat at week @ ( @ @ to @ @ % ; p = @ ) ; RTS increased LBM at week @ ( p < @ ) and week @ ( @ @ to @ @ kg ; p < @ ) , and decreased percentage body fat at week @ ( @ @ to @ @ % ; p < @ ) .


In addition , compared to C , relative bench press @-RM increased for RTS ( @ @ % ; p < @ ) and RT ( @ @ % ; p = @ ) ; relative leg press @-RM increased for RTS ( @ @ % ; p < @ ) and RT ( @ @ % ; p < @ ) ; RTS increased relative Margaria stair-climbing power ( @ @ % ; p < @ ) ; and , relative @-m walk time decreased for RT ( -@ @ % ; p < @ ) and RTS ( -@ @ % ; p = @ ) .


RT increased estimated VO@Max at week @ ( p < @ ) and @ ( @ @ to @ @ ml/kg/min ; p = @ ) compared to baseline .


Lastly , RTS increased estimated VO@Max at week @ ( @ @ to @ @ ml/kg/min ; p = @ ) compared to baseline .


Creatine and whey protein supplementation may not provide additional benefits in older adults performing periodized RT to augment muscular and functional performance .


Our previous study found that cortical gray matter ( cGM ) volume predicted vascular cognitive impairment independent of age-related white matter changes ( WMC ) .


We aimed to investigate predictors for cGM volume in ischemic stroke patients with confluent WMC .


One-hundred post-stroke patients with confluent WMC were recruited into the study .


All volumetric measures were standardized by intracranial volume as volume ratio .


Univariate analyses and multivariate linear regression models were used to test relationship of cGM volume with basic demography , vascular risk factors , APOE status , WMC volume ( periventricular and deep WMC ) , infarct measures ( volume , number and location ) and microbleed ( number , presence and location ) .


After controlling for significant variables in the univariate analyses , multivariate linear regression models found that old age ( = -@ , p = @ ) , low triglyceride ( = @ , p = @ ) , periventricular WMC ( PVWMC ) ( = -@ , p < @ ) and presence of thalamic microbleed ( = -@ , p = @ ) were independently predictive of less cGM volume ratio .


Age , PVWMC and left thalamic microbleed predict less cGM volume .


Alcohol consumption of college students has a fluctuating nature , which might impact the measurement of intervention effects .


By using @ follow-up time-points , this study tested whether intervention effects are robust or might vary over time .


Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment ( EMA ) with @ data time-points in total .


Students between @ and @ years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental ( n = @ : web-based brief alcohol intervention ) and control condition ( n = @ : no intervention ) .


Outcome measures were weekly alcohol consumption , frequency of binge drinking , and heavy drinking status .


According to the intention-to-treat principle , regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points .


Intervention effects were found for a ) weekly alcohol consumption at @ , @ , @ , @ , and @ weeks follow-up , b ) frequency of binge drinking at @ , @ , @ , and @ weeks follow-up , and c ) heavy drinking status at @ , @ , @ , and @ weeks follow-up .


This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions .


Therefore , future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness .


Using phase @ trial data for sunitinib versus interferon ( IFN ) - in treatment-naive patients with metastatic renal cell carcinoma , retrospective analyses characterized sunitinib-associated fatigue and its impact on patient-reported health-related quality of life ( HRQoL ) .


Patients received sunitinib at a dose of @ mg/day on a schedule of @ weeks on/@ weeks off ( @ patients ) or IFN - at a dose of @ MU subcutaneously @ times per week ( @ patients ) .


HRQoL was self-assessed using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-@-item ( FKSI-@ ) questionnaire , with fatigue assessed using its Disease-Related Symptoms subscale .


Fatigue was also assessed by providers using Common Terminology Criteria for Adverse Events ( CTCAE ) .


A repeated-measures model ( M@ ) and random intercept-slope model ( M@ ) characterized sunitinib-associated fatigue over time .


Another repeated-measures model examined the relationship between HRQoL scores and CTCAE fatigue grade .


M@ demonstrated that the initial increase in patient-reported fatigue with sunitinib was worst during cycle @ , with mean values numerically better at subsequent cycles ; most pairwise comparisons of consecutive CTCAE fatigue cycle means were not found to be statistically significant .


M@ demonstrated that the overall trend ( slope ) for patient-reported and CTCAE fatigue with sunitinib was not statistically different from @ .


The relationship between most HRQoL scores and CTCAE fatigue was close to linear regardless of treatment , with lower scores ( worse HRQoL ) corresponding to higher fatigue grade .


The majority of HRQoL scores were better with sunitinib versus IFN - for the same CTCAE fatigue grade .


Patients reported worse fatigue during the first sunitinib cycle .


However , in subsequent consecutive cycles , less fatigue was reported with no statistically significant worsening .


CTCAE fatigue assessment may not fully capture patient treatment experience .


Endogenous anterior uveitis ( AU ) , when untreated , may lead to vision loss .


This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition .


This phase III , double-masked , noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate @ % ( n = @ ) four times daily , alternating with vehicle four times daily , or prednisolone acetate @ % ( n = @ ) eight times daily .


The @-day treatment period was followed by a @-day dose-tapering period and a @-day observation period .


The primary efficacy end point was change in anterior chamber cell grade ( range , @ for @ cell to @ for > @ cells ) from baseline to day @ .


At day @ , the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate ( -@ vs. -@ , P = @ ) .


The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day @ were @ % vs. @ % ( P = @ ) and at day @ were @ % vs. @ % ( P = @ ) .


A significant between-group difference in the mean IOP increase was seen at day @ ( @ mm Hg for difluprednate-treated patients and @ mm Hg for prednisolone acetate-treated patients , P = @ ) but not at other time points .


The mean IOP values in both groups remained less than @ mm Hg throughout the study .


Difluprednate @ % four times daily is well tolerated and is noninferior to prednisolone acetate @ % eight times daily for the treatment of endogenous AU .


( ClinicalTrials.gov number , NCT@ . )


To compare the differences in the efficacy on speech and swallowing dysfunction of medulla oblongata palsy ( MOP ) after brainstem infarction between electroacupuncture at eight-neck-occiput points and routine acupoints .


Seventy-two patients were randomized into a neck-occiput points group and a meridian points group , @ cases in each one .


In the neck-occiput points group , the eight-neck-occiput points ( Neck @-@ points , Occiput @-@ points ) were selected .


In the meridian points group , Lianquan ( CV @ ) , Futu ( LI @ ) , Tongli ( HT @ ) , Hegu ( LI @ ) and the others were selected .


Electroacupuncture was used in the two groups , dense-dispersion wave , retaining for @ min .


The treatment was given once a day , @ treatments a week .


Totally , @ weeks were required .


The symptom scores of speech and swallowing dysfunction were observed before and after treatment in the two groups .


The efficacy was compared between the two groups .


The scores of speech and swallowing dysfunction were improved significantly after treatment in the two groups ( P < @ , P < @ ) .


The results in the neck-occiput points group were better than those in the meridian points group ( both P < @ ) .


The curative rate of speech dysfunction was @ % ( @/@ ) and that of swallowing dysfunction was @ % ( @ / @ ) in the neck-occiput points group , which were better than @ % ( @/@ ) and @ % ( @/@ ) in the meridian points group , respectively .


The differences were significant in comparison of the two groups ( P < @ , P < @ ) .


Electroacupuncture at eight-neck-occiput points achieves a better efficacy on speech and swallowing dysfunction of MOP after brainstem infarction as compared with the routine acupoints .


This therapy is characterized as more accurate point localization and safer operation .


Wet-wrap treatment ( WWT ) has been advocated as a relatively effective treatment in children with severe atopic dermatitis ( AD ) .


WWT often serves as crisis intervention for AD .


We sought to evaluate the use of WWT with diluted corticosteroids in comparison with emollient in children with severe AD during @ weeks in a proactive schedule during which the frequency of corticosteroid applications was tapered .


A randomized , double-blind , placebo-controlled study was performed in children aged @ months to @ years with severe AD ( objective SCORAD at least @ @ ) , comparing WWT with diluted corticosteroids ( @:@ mometasone furoate @ % ointment and for the face @:@ mometasone furoate @ % ointment under a mask ) with emollient ( petrolatum @ % in cetomacrogol cream ) .


The primary outcome was improvement of the objective SCORAD ; secondary outcomes included Patient-Oriented Eczema Measure and quality-of-life index .


WWT with diluted corticosteroids acted faster and was more efficacious than WWT with emollients .


Best results were obtained in age groups @ to @ years and @ to @ years .


The difference in efficacy evaluated by objective SCORAD was significant at all measuring points .


This also applied to the quality-of-life index .


The study group was relatively small .


WWT for severe AD is an effective therapy option for at least a period of @ weeks .


The common variants in the fat mass and obesity-associated ( FTO ) gene have been associated with obesity and insulin resistance .


Recently , studies also linked FTO variants with macronutrient intakes .


We aimed to investigate whether diet interventions varying in macronutrients modified the effects of FTO genotypes on changes in insulin resistance .


We genotyped FTO variants rs@ and rs@ and measured insulin resistance in fasting plasma samples at baseline and at @-mo and @-y visits in @ overweight or obese adults ( aged @-@ y , @ % women ) from a randomized weight-loss dietary interventional trial , the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial .


We assessed interactions between FTO variants and intakes of dietary fat and protein in relation to change in body weight and insulin resistance using generalized estimating equation models .


We found significant interactions between rs@ and dietary fat on changes in homeostasis model assessment of insulin resistance ( HOMA-IR ) and insulin ( P = @ and @ , respectively ) .


Each risk allele ( A ) of rs@ showed a trend to be related to a @-unit less reduction in both log ( insulin ) and log ( HOMA-IR ) among the participants assigned to low-fat diets ( both P = @ ) , but this was not significantly related to reduction in those assigned to high-fat diets ( both P > @ ) during the @-y period of intervention .


Our data showed that the association between rs@ and changes in insulin resistance was not modified by diet macronutrient intakes .


Our results show that carriers of the risk alleles of rs@ benefit differently in improving insulin sensitivity by consuming high-fat weight-loss diets rather than low-fat diets .


Still , given our data , we acknowledge it is difficult to determine whether fat or carbohydrate contributed to the observed associations .


The ideal bioptic strategy for CaP detection is still to be completely defined .


The aim of our study is to compare transperineal ( TP ) and transrectal ( TR ) approaches , in a @-core initial prostate biopsy for CaP detection .


A prospective controlled study was conducted enrolling @ consecutive patients with a PSA level greater than @ ng/mL and/or an abnormal DRE .


TR versus TP @-core initial prostatic biopsies were performed on @ and @ patients , respectively , with a randomisation ratio of @:@ .


The cancer detection rates were @ ( @ out of @ patients ) , and @ % ( @ out of @ patients ) , respectively , using the TR or the TP approach ( p = @ ) .


The overall cancer core rate was significantly higher when the TP approach was used : @ % ( @ out of @ cores ) and @ % ( @ out of @ cores ) , with the TP and the TR approach , respectively ( p = @ ) .


The cores were significantly longer performing TP approach : at the site `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) ; at `` @ '' ( @ versus @ mm , p = @ ) .


As to the biopsy related pain , the mean pain level perceived by patients during the TR approach was @ @ versus @ @ registered during TP approach ( p = @ ) .


No significant differences were found in cancer detection rate , cancer core rate between TP and TR approaches for prostatic biopsy .


Even in terms of complication rate or pain level , it can not be concluded that one procedure is superior to the other one .


Apparently , strictly following our protocol , TP approach seems to offer a better sampling at the level of the apex and the TZ , however without adding any significant advantage in terms of overall cancer detection rate .


The role of patient age in the efficacy of mesenchymal stem cell ( MSC ) therapy in ischemic cardiomyopathy ( ICM ) is controversial .


This study sought to determine whether the therapeutic effect of culture-expanded MSCs persists , even in older subjects .


Patients with ICM who received MSCs via transendocardial stem cell injection ( TESI ) as part of the TAC-HFT ( Transendocardial Autologous Cells in Ischemic Heart Failure ) ( n = @ ) and POSEIDON ( Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis ) ( n = @ ) clinical trials were divided into @ age groups : younger than @ and @ years of age and older .


Functional capacity was measured by @-min walk distance ( @MWD ) and quality of life using the Minnesota Living With Heart Failure Questionnaire ( MLHFQ ) score , measured at baseline , @ months , and @ year post-TESI .


Various cardiac imaging parameters , including absolute scar size , were compared at baseline and @ year post-TESI .


The mean @MWD was similar at baseline and increased at @ year post-TESI in both groups : @ @ m ( p = @ ) for the younger and @ @ m ( p = @ ) for the older participants ( p = NS between groups ) .


The older group exhibited a significant reduction in MLHFQ score ( -@ @ ; p = @ ) , whereas the younger than @ age group had a borderline significant reduction ( -@ @ ; p = @ ) from baseline ( p = NS between groups ) .


Although there were significant reductions in absolute scar size from baseline to @ year post-TESI , the effect did not differ by age .


MSC therapy with TESI in ICM patients improves @MWD and MLHFQ score and reduces myocardial infarction size .


Importantly , older individuals did not have an impaired response to MSC therapy .


To compare the intraoperative pain , anxiety , undesired movement , and cooperation between patients receiving oral diazepam or intravenous ( IV ) midazolam for conscious sedation during cataract surgery under topical anesthesia .


Ambulatory surgical center , Honolulu , Hawaii , USA .


Prospective randomized controlled trial .


Patients having first-time cataract extraction with topical anesthesia were randomized to receive sedation with oral diazepam @ minutes before surgery or IV midazolam immediately preceding surgery .


The outcomes of intraoperative pain , anxiety , undesired movement , and poor cooperation were observed by the surgeon and recorded during surgery .


One hundred fifty-six cataract surgeries were included , @ in the IV midazolam group and @ in the oral diazepam group .


Twenty-four patients ( @ % ) in the IV group and @ patients ( @ % ) in the oral group showed undesired movement ( P < @ ) .


Seven patients ( @ % ) in the IV group and @ patients ( @ % ) in the oral group showed poor cooperation ( P > @ ) .


Fifteen patients ( @ % ) in the IV group and @ patients ( @ % ) in the oral group had anxiety ( P > @ ) .


Three patients ( @ % ) in the IV group and @ patients ( @ % ) in the oral group experienced pain ( P > @ ) .


Fewer patients receiving oral diazepam @ minutes before cataract surgery than patients receiving IV midazolam immediately preceding surgery showed undesired movement during surgery .


There was no statistically significant difference in the number of patients showing poor cooperation or experiencing pain or anxiety between the @ groups .


To compare the efficacy of @-stage versus @-stage lateral maxillary sinus lift procedures .


Sixty partially edentulous patients requiring @ to @ implants and having @ to @ mm of residual bone height and at least @ mm bone width below the maxillary sinus , as measured on CT scans were selected .


They were randomised according to a parallel group study design into two equal arms to receive either a @-stage lateral window sinus lift with simultaneous implant placement or a @-stage procedure with implant placement delayed by @ months , using a bone substitute in three different centres .


Implants were submerged for @ months , loaded with reinforced provisional prostheses , which were replaced , after @ months , by definitive prostheses .


Outcome measures , assessed by masked assessors , were : augmentation procedure failures ; prosthesis failures and implant failures ; complications ; and marginal peri-implant bone level changes .


Patients were followed up to @ year after loading .


Only data of implants placed in @ to @ mm of bone height were reported .


Two patients dropped out from the @-stage group and none from the @-stage group .


No sinus lift procedure failed in the @-stage group but one failed in the @-stage group , the difference being not statistically significant ( P = @ ) .


Two prostheses failed or could not be placed in the planned time in the @-stage group and one in the @-stage group , the difference being not statistically significant ( P = @ ) .


Three implants failed in three patients of the @-stage group , versus one implant in the @-stage group , the difference being not statistically significant ( P = @ ) .


Two complications occurred in the @-stage group and one in the @-stage group , the difference being not statistically significant ( P = @ ) .


One year after loading , @-stage treated patients lost an average of -@ mm ( SD : @ ) of peri-implant bone and @-stage sites about -@ mm ( SD : @ ) .


There were no statistically significant differences in bone level change between groups @ year after loading ( -@ mm @ % CI : -@ to @ P = @ ) .


No statistically significant differences were observed between implants placed according to @ - or @-stage sinus lift procedures .


However this study may suggest that in patients having residual bone height between @ to @ mm below the maxillary sinus , there might be a slightly higher risk for implant failures when performing a @-stage lateral sinus lift procedure .


The main aim was to investigate the effectiveness of a novel internal teat sealant ( ITS ) formulation containing bismuth subnitrate and the antiseptic chlorhexidine , in adult cows ( Trial A ) and nulliparous heifers ( Trial B ) , to reduce the incidence of new intramammary infection ( IMI ) between treatment and calving and reduce the prevalence of IMI within @ days following calving .


In Trial A dairy cows ( n = @ ) without history of clinical mastitis and with a maximum composite milk somatic cell count < @,@ cells/mL during the current lactation were enrolled from three spring-calving mainly pasture-based herds immediately following the final milking .


In Trial B all heifers ( n = @ ) were enrolled from two herds approximately @ weeks before the start of calving .


Glands were randomly assigned to controls or treatment with ITS , and mammary secretion samples were taken from all glands prior to treatment , and on two occasions @-@ and @-@ days post-calving to determine the incidence of new IMI and the prevalence of IMI immediately post-calving .


Additionally , cows in Trial A were monitored for cases of clinical mastitis ( CM ) in the non-lactating period and animals in both trials were monitored for cases of CM within @ days of calving .


The ITS reduced the estimated incidence of new IMI with both major and any pathogens compared to control glands in cows ( @ vs. @ % and @ vs. @ % , respectively ) and in heifers ( @ vs. @ % and @ vs. @ % , respectively ) ( p < @ ) .


The ITS reduced the estimated prevalence of a major or any pathogen compared to untreated controls at both @-@ and @-@ days post-calving , in both cows and heifers .


Additionally , the ITS reduced the incidence of CM in the non-lactating period in cows ( -@ % , p = @ ) and in the @ days following calving in heifers ( -@ % , p = @ ) , and tended to reduce the estimated incidence of CM in cows post-calving ( -@ % , p = @ ) .


The novel ITS reduced the incidence of new IMI , and the prevalence of IMI at calving in both adult cows and heifers , and reduced the incidence of CM in the non-lactating period of cows and in the first @ days after calving in heifers .


The results of these trials demonstrate the efficacy of a novel ITS for the control of mastitis in likely uninfected dairy cows over the non-lactating period and in heifers in late pregnancy .


We report the results of a phase II trial of adding the anti-ascular endothelial growth factor ( VEGF ) bevacizumab to gemcitabine neoadjuvant chemotherapy for patients with borderline and unresectable non-metastatic pancreatic cancer .


Patients were assigned to one of the two treatment arms .


Both groups received @,@ mg/m ( @ ) gemcitabine on days @ , @ , and @ of a @-week cycle for a total of four cycles .


Group @ received @ mg/kg bevacizumab for six weeks ( three doses ) , every second week , starting at week @ of gemcitabine therapy .


Group @ received @ mg/kg bevacizumab for @ weeks ( six doses ) , every second week , starting at week @ of gemcitabine therapy .


The objective of the present study was to assess the rate of complete radical resection and overall survival .


A total of @ patients were enrolled : @ patients had unresectable and @ patients had borderline-resectable pancreatic cancer .


Eleven patients ( @ % ) underwent resection .


The median overall survival of patients who underwent tumor resection was @ months ( @ % confidence interval = @-@ months ) .


In general , adding bevacizumab to neoadjuvant gemcitabine does not improve outcomes for patients with locally advanced pancreatic cancer .


However , in individual cases , surgery is consequently possible and prolonged survival may be observed .


Heavy drinking poses significant risks to the health and survival of individuals infected with HIV , particularly those coinfected with hepatitis C virus ( HCV ) .


However , little is known about patients ' perceptions of these risks , and whether these perceptions relate to their alcohol consumption .


A sample of @ heavily drinking HIV primary care patients ( @ % male ; @ % minority ; @ % with HCV ) reported on their perceptions of the medical risks of drinking and on their alcohol consumption prior to participation in a drinking-reduction intervention trial .


In the HIV-infected sample as a whole , @ % reported that they had a medical problem made worse by drinking , and @ % reported restricting drinking to avoid future medical problems .


Although patients coinfected with HIV/HCV reported greater efforts to restrict drinking to avoid future medical problems ( adjusted odds ratio = @ ) , their reported drinking quantity and frequency did not differ from that of HIV mono-infected patients .


Awareness of medical risk was not associated with drinking level .


Effort to restrict drinking to avoid medical risk was associated with lower drinking quantity , frequency , and binge frequency ( ps < @ ) , but the association with binge frequency was specific to patients without HCV .


Over one-third of HIV patients are unaware of the medical risks of drinking , and do not restrict use , suggesting the need for intervention in this group .


Patients coinfected with HIV/HCV may report more effort to restrict drinking , but their reported drinking quantity and frequency suggest that they are actually drinking just as heavily as HIV mono-infected patients .


Awareness of medical risk was unrelated to drinking , which suggests the need for interventions consisting of more than simple education .


However , reported effort to restrict drinking did predict less drinking , suggesting the importance of patient commitment and initiative in change .


In a nonclinical trial setting , we sought to determine the proportion of individuals with coronary artery disease ( CAD ) with optimal risk factor levels based on the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation ) trial .


In the COURAGE trial , the addition of percutaneous coronary intervention ( PCI ) to optimal medical therapy did not reduce the risk of death or myocardial infarction in stable CAD patients but resulted in more revascularization procedures .


The REGARDS ( REasons for Geographic And Racial Differences in Stroke ) study is a national prospective cohort study of @,@ African-American and white community-dwelling individuals older than @ years of age who enrolled in @ through @ .


We calculated the proportion of @,@ participants with self-reported CAD meeting @ risk factor goals based on the COURAGE trial : @ ) aspirin use ; @ ) systolic blood pressure < @ mm Hg and diastolic blood pressure < @ mm Hg ( < @ mm Hg if diabetic ) ; @ ) low-density lipoprotein cholesterol < @ mg/dl , high-density lipoprotein cholesterol > @ mg/dl , and triglycerides < @ mg/dl ; @ ) fasting glucose < @ mg/dl ; @ ) nonsmoking status ; @ ) body mass index < @ kg/m ( @ ) ; and @ ) exercise@ days per week .


The mean age of participants was @ @ years ; @ % were African American and @ % were female .


Overall , the median number of goals met was @ .


Less than one-fourth met@ of the @ goals , and @ % metall @ goals for aspirin , blood pressure , and low-density lipoprotein cholesterol .


Older age , white race , higher income , more education , and higher physical functioning were independently associated with meeting more goals .


There is substantial room for improvement in risk factor reduction among U.S. individuals with CAD .


This trial examined diaries of hot flash events reported upon occurrence to assess the test/retest reliability of the diaries and their ability to measure treatment effects on hot flash frequency and severity .


Forty-two postmenopausal women ( aged @ y ; @-@ hot flashes/wk ) were randomized ( @:@:@ ) to placebo , raloxifene @ mg , or paroxetine @ mg daily for @ weeks .


Diaries of hot flash frequency and severity were evaluated at @-week intervals ( twice before study treatment and thrice during study treatment ) .


Forty-one women were evaluated .


Baseline characteristics were similar between groups ( eg , mean , @ hot flashes/wk ) .


Concordance correlation coefficients between screening ( week -@ ) and baseline ( week -@ ) measures of hot flash frequency and severity were @ and @ , respectively .


After @ weeks , the mean ( @ % CI ) percent changes from baseline in weekly hot flash frequency were as follows : placebo , -@ % ( -@ to -@ ) ; raloxifene , -@ % ( -@ to @ ) ; paroxetine , -@ % ( -@ to -@ ) ; the mean ( @ % CI ) percent changes in hot flash severity were as follows : placebo , -@ % ( -@ to -@ ) ; raloxifene , -@ % ( -@ to @ ) ; paroxetine , -@ % ( -@ to @ ) .


There were no significant differences in hot flash diary results between treatment groups .


Measures of hot flash frequency and severity show acceptable test/retest reliability between screening and baseline .


Reductions in vasomotor symptoms by raloxifene are numerically less than those seen with placebo , but no statistically significant treatment differences have been documented in this small study .


The large effect of placebo and the significant reduction in vasomotor symptoms by paroxetine are consistent with other studies .


The diary seems to be suitable for use in hot flash clinical trials .


We present a long-term safety , immunogenicity , and effectiveness study of a quadrivalent human papillomavirus ( HPV@ ) vaccine .


Sexually naive boys and girls aged @ to @ years ( N = @ ) were assigned ( @:@ ) to receive HPV@ vaccine or saline placebo at day @ and months @ and @ .


At month @ , the placebo group ( n = @ ) received HPV@ vaccine following the same regimen and both cohorts were followed through month @ .


Subjects @ years were eligible for effectiveness evaluations .


The primary objective was to evaluate the long-term anti-HPV@ / @/@/@ serological levels .


The secondary objective was to estimate vaccine effectiveness against HPV@/@/@ / @-related persistent infection or disease .


For each of the HPV@ vaccine types , vaccination-induced anti-HPV response persisted through month @ .


Among @ subjects who received HPV@ vaccine at a mean age of @ , none developed HPV@/@/@ / @-related disease or persistent infection of @ months ' duration .


Acquisition of new sexual partners ( among those @ years ) was @ per year .


Subjects receiving HPV@ vaccine at month @ ( mean age @ years ) had a similar baseline rate of seropositivity to @ of the @ HPV types to those vaccinated at day @ ( mean age @ years ; @ % -LSB- @ of @ -RSB- vs @ % -LSB- @ of @ -RSB- ) ; however , @ of the @ subjects vaccinated at the later age were seropositive to @ vaccine types , indicating previous HPV exposure .


No new significant serious adverse events were observed for @ years postvaccination in both genders .


When administered to adolescents , the HPV@ vaccine demonstrated durability in clinically effective protection and sustained antibody titers over @ years .


A strong association exists between the use of tamsulosin and the occurance of intraoperative floppy iris syndrome .


Several methods were advocated to overcome the progressive intraopertive miosis.Our purpose was to investigate the effect of a mydriatic-cocktail soaked cellulose sponge on perioperative pupil diameter in tamsulosin-treated patients undergoing elective cataract surgery .


Patients using tamsulosin were dilated either with mydriatic-cocktail soaked sponge ( group @ ) or with conventional eyedrop regimen ( group @ ) .


Control patients not taking any @ adrenergic receptor inhibtors were also dilated with mydriatic sponge ( group @ ) .


In all groups oxybuprocain @ % , cocain @ % , tropicamide @ % , phenylephrine @ % , diclophenac @ % along with chloramphenicol @ % were used preoperatively.Pupil diameter ( mm ) was measured preoperatively , after nucleus delivery , and before IOL implantation .


Adverse effects associated with the use of sponge , minor and major intraoperative complications , the use of iris retractors and operation time were recorded.Differences in general between groups were analyzed with a one way analysis of variance ( ANOVA ) ; differences between groups in proportions were assessed by Fisher 's exact test .


Mean pupil diameter ( mm ) was preopertively : @ @ , @ @ and @ @ ( ANOVA : p = @ ) ; after nucleus delivery : @ @ , @ @ and @ @ ( ANOVA : p = @ ) ; before IOL implantation : @ @ , @ @ and @ @ ( ANOVA : p = @ ) .


No adverse effect related to sponge use was detected .


Frequency of minor complications , and iris hook use was similar in the two tamsulosin treated group .


Operation time did not differ significantly in the three groups .


We have found that using a mydriatic cocktail-soaked wick - an alternative way to achieve intraoperative mydriasis for cataract surgery - was as effective and safe as the conventional repeated eyedrops regiment for tamsulosin treated patients .


Gastroparesis remains a challenging syndrome to manage , with few effective treatments and a lack of rigorously controlled trials .


Tricyclic antidepressants are often used to treat refractory symptoms of nausea , vomiting , and abdominal pain .


Evidence from well-designed studies for this use is lacking .


To determine whether treatment with nortriptyline results in symptomatic improvement in patients with idiopathic gastroparesis .


The NORIG ( Nortriptyline for Idiopathic Gastroparesis ) trial , a @-week multicenter , parallel-group , placebo-controlled , double-masked , randomized clinical trial from the National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium ( GpCRC ) , comparing nortriptyline with placebo for symptomatic relief in idiopathic gastroparesis .


One hundred thirty patients with idiopathic gastroparesis were enrolled between March @ and June @ at @ US academic medical centers .


Patient follow-up was completed in October @ .


Inclusion criteria included delayed gastric emptying and moderate to severe symptom scores using the Gastroparesis Cardinal Symptom Index ( GCSI ) .


INTERVENTIONS Nortriptyline vs placebo .


Study drug dose was increased at @-week intervals ( @ , @ , @ , @ mg ) up to @ mg at @ weeks .


The primary outcome measure of symptomatic improvement was a decrease from the patient 's baseline GCSI score of at least @ % on @ consecutive @-week GCSI assessments during @ weeks of treatment .


The primary symptomatic improvement outcome did not differ between @ patients randomized to nortriptyline vs @ patients randomized to placebo : @ ( @ % -LSB- @ % CI , @ % -@ % -RSB- ) in the nortriptyline group vs @ ( @ % -LSB- @ % CI , @ % -@ % -RSB- ) in the placebo group ( P = @ ) .


Treatment was stopped more often in the nortriptyline group ( @ -LSB- @ % -LCB- @ % CI , @ % -@ % -RCB- -RSB- ) than in the placebo group ( @ -LSB- @ % -RSB- -LCB- @ % CI , @ % -@ % -RCB- -RSB- ) ( P = @ ) , but numbers of adverse events were not different ( @ -LSB- @ % CI , @-@ -RSB- vs @ -LSB- @ % CI , @-@ -RSB- ) ( P = @ ) .


Among patients with idiopathic gastroparesis , the use of nortriptyline compared with placebo for @ weeks did not result in improvement in overall symptoms .


These findings do not support the use of nortriptyline for idiopathic gastroparesis .


Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size .


We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling .


In a multicenter , double-blind , randomized trial , we assigned @ patients with an acute anterior ST-segment elevation myocardial infarction ( STEMI ) who were undergoing percutaneous coronary intervention ( PCI ) within @ hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine ( administered intravenously at a dose of @ mg per kilogram of body weight ) or matching placebo before coronary recanalization .


The primary outcome was a composite of death from any cause , worsening of heart failure during the initial hospitalization , rehospitalization for heart failure , or adverse left ventricular remodeling at @ year .


Adverse left ventricular remodeling was defined as an increase of @ % or more in the left ventricular end-diastolic volume .


A total of @ patients in the cyclosporine group and @ in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at @ year .


The rate of the primary outcome was @ % in the cyclosporine group and @ % in the control group ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events , including recurrent infarction , unstable angina , and stroke .


No significant difference in the safety profile was observed between the two treatment groups .


In patients with anterior STEMI who had been referred for primary PCI , intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at @ year .


( Funded by the French Ministry of Health and NeuroVive Pharmaceutical ; CIRCUS ClinicalTrials.gov number , NCT@ ; EudraCT number , @-@-@ . )


To evaluate the effects of acute and daily consumption of high-oleic peanuts ( HOP ) on inflammation and glucose homeostasis in overweight/obese men .


In a @-week randomized clinical trial , males with body mass index of @ @ kg/m ( @ ) and aged @-@ years were assigned to the groups : control ( CT , n = @ ) ; conventional peanuts ( CVP , n = @ ) ; or HOP ( n = @ ) .


They followed a hypocaloric-diet with or without @ g/day of CVP or HOP .


Main outcomes were changes in fasting blood biomarkers and postprandial insulin , glucose , tumor necrosis factor-alfa ( TNF - ) , and interleukin-@ ( IL-@ ) responses after acute peanut intake .


At baseline , HOP showed significantly lower postprandial responses of glucose , insulin , and TNF - than CVP and CT. .


Changes in fasting blood biomarkers did not differ between groups after the @-week intervention .


However , within groups , total cholesterol decreased in CT , and all groups reduced High-density lipoprotein ( HDL-c ) .


Triglycerides were reduced in HOP and CVP .


IL-@ increased significantly in all groups while only the CT and CVP showed increased TNF - after intervention .


Acute high-oleic peanut consumption leads to stronger moderation of postprandial glucose , insulin , and TNF - concentrations than CVP and control meal intake .


Whether daily intake of high-oleic peanuts has additional benefits to CVP remains uncertain .


To evaluate the safety and efficacy of urinary kallidinogenase for recombinant tissue-type plasminogen activator ( rt-PA ) intravenous thrombolytic treatment in patients with acute cerebral infarction .


All @ patients with acute cerebral infarction were randomized @:@ into an experimental group ( @ cases ) and a control group ( @ cases ) .


Patients in the control group were administrated rt-PA ( @/@ mg/kg ) while patients in the experimental group were given urinary kallidinogenase by intravenous drip ( @ PNAU/d , for @ days ) after rt-PA intravenous thrombolytic treatment ( @ mg/kg ) .


The main evaluation index was NIHSS and BI .


Compared to the control group , the NIHSS scores were significantly lower @ and @ days after thrombolytic therapy ( t = @ , @ ; p < @ ) .


BI scores were obviously higher at @ days after thrombolytic therapy in the experimental group ( t = @ , p < @ ) .


Urinary kallidinogenase may improve the treatment effect for rt-PA intravenous thrombolytic treatment in patients with acute cerebral infraction .


To assess the impact of dutasteride compared with placebo on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia , using pooled data from dutasteride phase III studies .


Nocturia was assessed using Question @ of the International Prostate Symptom Score questionnaire .


Efficacy measures included : mean change in nocturia at @ months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < @ at study end in patients with baseline score @ .


In total , @,@ patients with a mean age of @ years were evaluated .


From month @ onwards , mean nocturia improvements were significantly superior with dutasteride than with placebo ( p @ ) .


Reduction in nocturia was significantly better with dutasteride than with placebo across all baseline subgroups tested ( p @ ) .


Also at month @ , dutasteride therapy resulted in a greater proportion of subjects with nocturia improvement compared with placebo ( p @ ) , with the largest treatment group differences in subjects with a baseline nocturia score of @ or @ .


Among patients with significant nocturia at baseline ( score @ ) , significantly more subjects with dutasteride versus placebo had a score < @ at month @ ( @ vs. @ % , p < @ ) .


After @ months of treatment , dutasteride treatment provided significantly greater improvements in nocturia , and less worsening , compared with placebo , primarily in subjects with two or three nocturia episodes per night .


Studies specifically designed to assess nocturia are required to prospectively confirm these findings .


There is increasing interest in the extraskeletal effects of vitamin D , particularly in the obese state with regard to the development of insulin resistance and diabetes .


The objective of the study was to determine the effect of @ doses of cholecalciferol ( vitamin D@ ) supplementation on insulin action ( Si ) and pancreatic - cell function in obese adolescents .


We performed a @-wk double-blind , randomized comparison of the effect of vitamin D@ supplementation on Si and - cell function in obese Caucasian adolescents ( body mass index > @ ( th ) percentile ) .


The subjects were randomly assigned to receive either @ IU/d ( n = @ ) or @ IU/d ( n = @ ) of vitamin D@ .


Each subject underwent a @-sample @ g oral glucose tolerance test , with glucose , insulin , and C-peptide measurements , to calculate Si and - cell function as assessed by the disposition index ( DI ) , with use of the oral minimal model before and after supplementation .


A total of @ subjects aged @ @ y were enrolled .


Included for analysis at follow-up were a total of @ subjects ( @ male and @ female adolescents ) , @ in each group .


Initial serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- was @ @ g/L .


There was no correlation between @ ( OH ) D concentrations and Si or DI .


There was a modest but significant increase in @ ( OH ) D concentration in the @ IU/d group ( @ @ g/L , P = @ ) but not in the @ IU/d group ( P = @ ) .


There was no change in Si or DI following vitamin D@ supplementation in either of the treatment groups ( all P > @ ) .


The current study shows no effect from vitamin D@ supplementation , irrespective of its dose , on - cell function or insulin action in obese nondiabetic adolescents with relatively good vitamin D status .


Whether obese adolescents with vitamin D deficiency and impaired glucose metabolism would respond differently to vitamin D@ supplementation remains unclear and warrants further studies .


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


Gestational diabetes mellitus ( GDM ) is associated with both maternal and offspring adverse effects .


The World Health Organization ( WHO ) has recently adopted novel GDM criteria .


The aim of this study was to evaluate the former WHO and a simplified version of the new International Association for Diabetes in Pregnancy Study Group ( IADPSG ) criteria as to prevalence of and risk factors for GDM in a Nordic Caucasian population .


A @ g oral glucose tolerance test was performed in @ women at @-@ and @-@ pregnancy weeks .


GDM was defined according to the WHO criteria as fasting plasma glucose @ mmol/L and/or @-hour plasma glucose @ mmol/L and by a simplified version of the IADPSG criteria as either fasting glucose @ mmol/L and/or @-h plasma glucose @ mmol/L .


One-hour glucose values were not available and were thus not included in the diagnosis of GDM by IADPSG .


Prevalence of GDM during pregnancy and risk factors for GDM at @-@ weeks were studied in retrospect according to each of the two criteria .


The total prevalence of GDM during pregnancy was @ % ( @/@ ) for the WHO criteria and @ % ( @/@ ) for the simplified IADPSG criteria .


High maternal age and short stature were independently associated with WHO GDM .


Maternal age , fasting insulin and no regular exercise at @-@ pregnancy weeks associated with simplified IADPSG GDM .


Simplified IADPSG criteria moderately increase GDM prevalence compared with the WHO criteria .


Risk factors for GDM differ with the diagnostic criteria used .


At the doses typically used to treat hypertriacylglycerolemia , fish oil may increase low-density lipoprotein ( LDL ) cholesterol and blood glucose levels .


The aim of the present study was to verify whether soy could attenuate the effects of fish oil on blood lipids and carbohydrate metabolism in patients with metabolic syndrome .


Sixty-five women ( @ @ y ) were studied with the use of a parallel , randomized design .


The control group maintained the usual diet ; the second group received @ g/d of soy ( kinako ) ; the third group received @ g/d of fish oil n-@ fatty acids ; and the fourth group received fish oil ( @ g/d ) and kinako ( @ g/d ) .


Assessments were performed at baseline and after @ and @ d.


In relation to baseline values , fish oil increased ( P < @ ) total and LDL cholesterol , glucose , insulin , and homeostasis model assessment of insulin resistance levels after @ d. Comparisons among groups demonstrated a decrease ( P < @ ) in total cholesterol in the fish oil and kinako group after @ d as compared with the fish oil group .


LDL cholesterol decreased ( P < @ ) in the kinako group as compared with the fish oil group .


Blood glucose and homeostasis model assessment of insulin resistance levels decreased after @ d ( P < @ and P < @ , respectively ) and insulin levels decreased ( P < @ ) after @ d when the kinako group was compared with the fish oil group .


The present study showed that kinako moderates the adverse effects of high doses of fish oil on LDL cholesterol , total cholesterol , and glucose metabolism levels .


To compare the relative plaque control efficacy of a marketed @ % stabilized stannous fluoride ( SnF@ ) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis ( DPIA ) .


This was a randomized , two-treatment , double-blind , parallel group design study that compared SnF@ and triclosan/copolymer dentifrices over a period of @ weeks .


DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of @ teeth and to calculate plaque area coverage .


Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer 's instructions .


Subjects had DPIA assessments on two separate days at the end of Week @ .


@ subjects were randomized to treatment .


Plaque area data for @ subjects per treatment group were compared at Week @ using ANCOVA .


The SnF@ group demonstrated a statistically significant reduction in overnight plaque at Week @ compared to baseline ( P = @ ) .


The reduction for the triclosan group at Week @ compared to baseline was not statistically significant ( P = @ ) .


At Week @ , the SnF@ group demonstrated a @ % lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant ( P < @ ) .


The Week @ adjusted mean change from baseline in overnight plaque for the SnF@ group was @ times greater versus that of the triclosan group ( P < @ ) .


The study purpose was to analyze @-year outcomes in a prospective , randomized trial of alemtuzumab ( ALEM ) versus rabbit antithymocyte globulin ( rATG ) induction in simultaneous kidney-pancreas transplantation ( SKPT ) .


From February @ through October @ , a total of @ SKPTs ( @ portal-enteric drainage ) were prospectively randomized to receive either single-dose ALEM ( @ mg intraoperatively ) or multiple-dose rATG antibody induction ( starting intraoperatively , minimum of @ doses administered ) with tacrolimus/mycophenolate and/or steroids .


Of @ kidney transplant patients enrolled in the study , @ received SKPTs ; @ ( @ % ) received ALEM and @ ( @ % ) received rATG induction .


Follow-up ranged from @ to @ months ( mean , @ months ) .


There were no significant differences between the @ groups in @-year patient ( @ % ALEM vs @ % rATG ) , kidney graft ( @ % ALEM vs @ % rATG ) , or pancreas graft ( @ % ALEM vs @ % rATG ) survival rates .


Death-censored kidney ( @ % ALEM vs @ % rATG ) and pancreas ( @ % ALEM vs @ % rATG ) graft survival rates were likewise comparable ( both , P = NS ) .


Acute rejection ( @ % ALEM vs @ % rATG ; P = @ ) and major infection ( @ % ALEM vs @ % rATG ; P = @ ) rates were slightly lower in the ALEM group ; cytomegalovirus infections were significantly lower ( @ % ALEM vs @ % rATG ; P = @ ) .


The incidence of late acute rejection was low in both groups .


There were no differences in early pancreas thromboses ( @ % ALEM vs @ % rATG ) , postoperative bleeding ( @ % ALEM vs @ % rATG ) , other surgical complications , or readmissions between groups .


In patients with functioning grafts , @-year mean serum creatinine ( @ ALEM vs @ mg/dL rATG ) , calculated abbreviated Modification of Diet in Renal Disease glomerular filtration rate ( @ ALEM vs @ mL/min/@ @ m ( @ ) rATG ) , glycosylated hemoglobin ( both @ % ) , and C-peptide ( @ ALEM vs @ ng/mL rATG ) levels were similar .


Single-dose ALEM and multiple dose rATG induction provided similar medium-term patient , kidney , and pancreas graft function and survival rates .


ALEM induction may be associated with less acute rejection and major infection over the long term .


To determine the mechanisms by which extended-release nicotinic acid reduces circulating lipoprotein ( a ) concentrations in hypertriglyceridemic patients .


Eight nondiabetic , obese male subjects ( aged @ years ; body mass index , @ kg/m ( @ ) ) with hypertriglyceridemia ( triglycerides , @ mg/dL ) were enrolled in an @ week , double blind , placebo-controlled cross-over study .


At the end of each treatment phase , fasted subjects received a @ mol/L per kg bolus injection of -LSB- @,@,@ - ( @ ) H@ -RSB- - l-Leucine immediately followed by constant infusion of -LSB- @,@,@ - ( @ ) H@ -RSB- - l-Leucine ( @ mol L ( -@ ) kg ( -@ ) h ( -@ ) ) for @ hours , and blood samples were collected .


A liquid chromatography-tandem mass spectrometry method was used to study apolipoprotein ( a ) ( Apo ( a ) ) kinetics .


The fractional catabolic rate of Apo ( a ) was calculated with a single compartmental model using the apolipoprotein B@ ( ApoB@ ) containing very low density lipoprotein tracer enrichment as a precursor pool .


Extended-release nicotinic acid decreased plasma triglycerides ( -@ % ; P = @ ) , raised high-density lipoprotein cholesterol ( +@ % ; P = @ ) , and decreased Apo ( a ) plasma concentrations ( -@ % ; P = @ ) .


Extended-release nicotinic acid also decreased ApoB@ ( @ % ; P = @ ) and proprotein convertase subtilisin/kexin type @ ( PCSK@ , -@ % ; P = @ ) plasma concentrations .


Apo ( a ) fractional catabolic rate and production rates were decreased by @ % ( @ versus @ pool/d ; P = @ ) and @ % ( @ versus @ nmol/kg per day ; P = @ ) , respectively .


Extended-release nicotinic acid treatment decreased Apo ( a ) plasma concentrations by @ % , production rates by @ % , and catabolism by @ % .


ApoB@ and PCSK@ concentrations were also decreased by treatment , but no correlation was found with Apo ( a ) kinetic parameters .


We sought to compare the effects of physical practice ( PP ) and mental practice ( MP ) on the immediate and long-term learning of the finger-to-thumb opposition sequence task ( FOS ) in children ; in addition , we investigated the transfer of this learning to an untrained sequence of movements and to the contralateral untrained hand .


This study included thirty-six @ - and @-year-old children who were randomly allocated into @ groups : MP , PP , and no practice ( NP ) .


The MP and PP groups were subjected to a single session of training with the dominant trained hand .


MP participants were trained by mentally rehearsing the movements , PP participants were trained by executing the movements , and the NP group had no training .


The performance of the trained sequence ( TS ) and untrained reverse sequence ( URS ) by each of the @ groups was evaluated under identical conditions before training , after @ min , and at @ days , @ days , and @ days after training .