Both studies also report a significant reduction of interleukin-@ in the wound exudate , supporting a mechanism involving a pulsed electromagnetic field effect on nitric oxide/cyclic guanosine monophosphate signaling , which modulates the body 's antiinflammatory pathways .


Adjunctive pulsed electromagnetic field therapy could impact the speed and quality of wound repair in many surgical procedures .


Therapeutic , I.


The objective of this study was to investigate the hypouricemic effects of green tea extract ( GTE ) in healthy individuals .


This study comprised @-week control , @-week interventional , and @-week follow-up periods .


Participants were assigned randomly at the interventional period to consume GTE at @ ( GTE@ ) , @ ( GTE@ ) , or @ ( GTE@ ) g/d .


Levels of serum uric acid ( SUA ) , uric acid clearance , and serum antioxidant power ( using trolox equivalent antioxidant capacity assay ) were measured at both ends of each study period .


Of @ participants , @ , @ , and @ received GTE@ , GTE@ , and GTE@ , respectively .


After @ weeks of consumption , the mean SUA level tended to decrease in all groups , with no statistical significance .


Serum uric acid reduction was greatest in GTE@ ( from @ @ mg/dL to @ @ mg/dL , @ % ) .


Uric acid clearance decreased significantly in GTE@ ( from @ @ mL/min per @ m to @ @ mL/min per @ m , @ % , P < @ ) and GTE@ ( from @ @ mL/min per @ m to @ @ mL/min per @ m , @ % , P < @ ) .


Serum antioxidant capacity ( TEAC ) increased significantly in GTE@ ( from @ @ mg/mL to @ @ mg/mL , @ % , P < @ ) .


There was no significant change in creatinine clearance .


Gastrointestinal adverse events were common , but usually mild , with no medical treatment required .


Green tea extract may modestly lower SUA level and decreases uric acid clearance .


Green tea extract also significantly elevated serum antioxidant capacity with a positive dosage effect .


The effect of GTE on SUA in healthy individuals was short term .


The effects of GTE on urate handling in patients with hyperuricemia or gout need to be determined .


An intradermal ( ID ) trivalent split-virion influenza vaccine ( IIV@-ID ) ( Fluzone ( ) Intradermal , Sanofi Pasteur , Swiftwater , PA ) has been available in the US since the @/@ influenza season for adults aged @-@ years .


This study examined whether adding a second B-lineage strain affects immunogenicity and safety .


This randomized , double-blind , multicentre trial evaluated the immunogenicity and safety of an intradermal quadrivalent split-virion influenza vaccine ( IIV@-ID ) in adults @-@ years of age in the US during the @-@ influenza season .


Participants were randomized @:@:@ to receive a single injection of IIV@-ID , licensed IIV@-ID , or an investigational IIV@-ID containing the alternate B-lineage strain .


Haemagglutination inhibition antibody titres were assessed in two-thirds of participants before vaccination and @ days after vaccination .


@ participants were vaccinated with IIV@-ID , @ with licensed IIV@-ID , and @ with an investigational IIV@-ID .


For all four vaccine strains , antibody responses to IIV@-ID were statistically non-inferior to the response to the IIV@-ID vaccines containing the matched strains .


For both B strains , post-vaccination antibody responses to IIV@-ID were statistically superior to the responses to IIV@-ID lacking the corresponding B strain .


Adverse events were similar for IIV@-ID and IIV@-ID .


The most commonly reported solicited reactions were pain , pruritus , myalgia , headache , and malaise ; and most were grade @ or @ and appeared and resolved within @ days of vaccination .


IIV@-ID was statistically non-inferior to the two pooled IIV@-ID vaccines for the proportions of participants with at least one grade @ or @ systemic reaction .


Antibody responses to the IIV@-ID were non-inferior to IIV@-ID for the A and matched B strains and superior for the unmatched B strains .


IIV@-ID was well tolerated without any safety concerns .


IIV@-ID may help address an unmet need due to mismatched B strains in previous influenza vaccines .


Blood transfusions are frequently given to patients with septic shock .


However , the benefits and harms of different hemoglobin thresholds for transfusion have not been established .


In this multicenter , parallel-group trial , we randomly assigned patients in the intensive care unit ( ICU ) who had septic shock and a hemoglobin concentration of @ g per deciliter or less to receive @ unit of leukoreduced red cells when the hemoglobin level was @ g per deciliter or less ( lower threshold ) or when the level was @ g per deciliter or less ( higher threshold ) during the ICU stay .


The primary outcome measure was death by @ days after randomization .


We analyzed data from @ of @ patients ( @ % ) who underwent randomization .


The two intervention groups had similar baseline characteristics .


In the ICU , the lower-threshold group received a median of @ unit of blood ( interquartile range , @ to @ ) and the higher-threshold group received a median of @ units ( interquartile range , @ to @ ) .


At @ days after randomization , @ of @ patients ( @ % ) assigned to the lower-threshold group , as compared with @ of @ ( @ % ) assigned to the higher-threshold group , had died ( relative risk , @ ; @ % confidence interval , @ to @ ; P = @ ) .


The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations .


The numbers of patients who had ischemic events , who had severe adverse reactions , and who required life support were similar in the two intervention groups .


Among patients with septic shock , mortality at @ days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold ; the latter group received fewer transfusions .


( Funded by the Danish Strategic Research Council and others ; TRISS ClinicalTrials.gov number , NCT@ . )


Most patients with acute coronary syndrome ( ACS ) are treated with statins , which reduce atherogenic triglyceride-rich lipoproteins .


It is uncertain whether triglycerides predict risk after ACS on a background of statin treatment .


This study examined the relationship of fasting triglyceride levels to outcomes after ACS in patients treated with statins .


Long-term and short-term relationships of triglycerides to risk after ACS were examined in the dal-OUTCOMES trial and atorvastatin arm of the MIRACL ( Myocardial Ischemia Reduction with Acute Cholesterol Lowering ) trial , respectively .


Analysis of dal-OUTCOMES included @,@ patients ( @ % statin-treated ) randomly assigned @ to @ weeks after ACS to treatment with dalcetrapib ( a cholesteryl ester transfer protein inhibitor ) or placebo and followed for a median @ months .


Analysis of MIRACL included @,@ patients treated with atorvastatin @ mg daily beginning @ to @ days after ACS and followed for @ weeks .


Fasting triglycerides at initial random assignment were related to risk of coronary heart disease death , nonfatal myocardial infarction , stroke , and unstable angina in models adjusted for age , sex , hypertension , smoking , diabetes , high-density lipoprotein cholesterol , and body mass index .


Fasting triglyceride levels were associated with both long-term and short-term risk after ACS .


In dal-OUTCOMES , long-term risk increased across quintiles of baseline triglycerides ( p < @ ) .


The hazard ratio in the highest/lowest quintile ( > @/@ mg/dl ) was @ ( @ % confidence interval : @ to @ ) .


There was no interaction of triglycerides and treatment assignment on the primary outcome .


In the atorvastatin group of MIRACL , short-term risk increased across tertiles of baseline triglycerides ( p = @ ) , with a hazard ratio of @ -LSB- corrected -RSB- ( @ % confidence interval : @ to @ ) in highest/lowest tertiles ( > @/@ mg/dl ) .


The relationship of triglycerides to risk was independent of low-density lipoprotein cholesterol in both studies .


Among patients with ACS treated effectively with statins , fasting triglycerides predict long-term and short-term cardiovascular risk .


Triglyceride-rich lipoproteins may be an important additional target for therapy .


( A Study of RO@ in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome ; NCT@ ) .


Both hepatitis C virus ( HCV ) mono-infected and HIV/HCV co-infected patients are in need of safe , effective , all-oral HCV regimens .


In a phase @ study we aimed to assess the efficacy and safety of grazoprevir ( MK-@ ; HCV NS@/@A protease inhibitor ) and two doses of elbasvir ( MK-@ ; HCV NS@A inhibitor ) in patients with HCV mono-infection and HIV/HCV co-infection .


The C-WORTHY study is a phase @ , multicentre , randomised controlled trial of grazoprevir plus elbasvir with or without ribavirin in patients with HCV ; here , we report findings for previously untreated ( genotype @ ) patients without cirrhosis who were HCV mono-infected or HIV/HCV co-infected .


Eligible patients were previously untreated adults aged @ years or older with chronic HCV genoype @ infection and HCV RNA at least @ IU/mL in peripheral blood without evidence of cirrhosis , hepatocellular carcinoma , or decompensated liver disease .


In part A of the study we randomly assigned HCV-mono-infected patients to receive @ weeks of grazoprevir ( @ mg ) plus elbasvir ( @ mg or @ mg ) with or without ribavirin ( arms A@-@ ) ; in part B we assigned HCV-mono-infected patients to @ or @ weeks of grazoprevir ( @ mg ) plus elbasvir ( @ mg ) with or without ribavirin ( arms B@-@ ) and HIV/HCV co-infected patients to @ weeks of therapy with or without ribavirin .


The primary endpoint was the proportion of patients achieving HCV RNA less than @ IU/mL @ weeks after end of treatment ( SVR@ ) .


Randomisation was by presence or absence of ribavirin , @ or @ weeks of treatment , and dosage of elbasvir .


Patients were stratified by gentoype @a versus @b .


The patients , investigators , and study site personnel were masked to treatment group assignements but the funder was not .


Analysis was by intention to treat .


This trial is registered at ClinicalTrials.gov , number NCT@ .


@ patients with HCV mono-infection ( n = @ ) and HIV/HCV co-infection ( n = @ ) were enrolled .


SVR@ for patients treated for @ weeks with or without ribavirin ranged from @-@ % in mono-infected and @-@ % in co-infected patients .


SVR@ rates in mono-infected and co-infected patients treated for @ weeks without ribavirin were @ % ( @ % CI @-@ ; @/@ ) and @ % ( @ % CI @-@ ; @/@ ) , respectively , and with ribavirin were @ % ( @ % CI @-@ ; @/@ ) and @ % ( @ % CI @-@ ; @/@ ) , respectively .


Among mono-infected patients with genotype @a infection treated for @ weeks , SVR@ was @ % ( @ % CI @-@ ; @/@ ) .


Five of six patients who discontinued early for reasons other than virological failure had HCV RNA less than @ IU/mL at their last study visit .


Virological failure among patients treated for @ weeks occurred in seven patients ( @/@ , @ % ) and was associated with emergence of resistance-associated variants to one or both drugs .


The safety profile of grazoprevir plus elbasvir with or without ribavirin was similar in mono-infected and co-infected patients .


No patient discontinued due to an adverse event or laboratory abnormality .


The most common adverse events were fatigue ( @ patients , @ % ) , headache ( @ , @ % ) , nausea ( @ , @ % ) , and diarrhoea ( @ , @ % ) .


Once-daily grazoprevir plus elbasvir with or without ribavirin for @ weeks in previously untreated HCV-mono-infected and HIV/HCV-co-infected patients without cirrhosis achieved SVR@ rates of @-@ % .


These results support the ongoing phase @ development of grazoprevir plus elbasvir .


Treatment options for adults with attention deficit hyperactivity disorder ( ADHD ) are limited .


The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release ( MPH-LA ) in adults with ADHD and evaluate the maintenance of effect of MPH-LA .


The study consisted of three treatment phases .


The double-blind dose-confirmation phase : @-week double-blind period ( @-week titration period , @-week fixed dose ) with randomization to MPH-LA @ , @ , or @mg/day or placebo .


The real-life dose-optimization phase : a @-week re-titration period to optimal dose ; and the double-blind maintenance of effect phase , a @-month double-blind randomized placebo-controlled maintenance of effect phase .


The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale ( DSM-IV ADHD RS ) and Sheehan Disability Scale ( SDS ) total scores from baseline to end of @-week confirmation phase and the percentage of treatment failures during the @-month maintenance of effect phase .


@ of @ screened patients were randomized to @ ( N = @ ) , @ ( N = @ ) , or @mg ( N = @ ) MPH-LA or placebo ( N = @ ) , and @ ( @ % ) completed .


@ ( @ % ) of completers were re-randomized to the double-blinded maintenance of effect phase and @ ( @ % ) of them completed .


Improvement from baseline in DSM-IV ADHD RS ( P < @ for all comparisons ) and SDS ( @mg , P = @ ; @mg , P = @ ; @mg , P < @ ) total scores was significantly greater vs. placebo for all MPH-LA doses .


Treatment failure rate was significantly lower with MPH-LA ( @ % ) versus placebo ( @ % ) during the @-month maintenance of effect phase .


Safety profile was consistent with the profile for MPH-LA in children ; percentage of serious adverse events was comparable between all MPH-LA arms ( @ % ) and placebo ( @ % ) , while percentage of adverse events was higher in MPH-LA arms .


MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients .


To compare the effect of melatonin and gabapentin on anxiety , pain , sedation scores , and satisfaction of surgeon in patients of cataract surgery .


One hundred thirty patients aged between @ and @ years scheduled for cataract surgery were randomly allocated to three study groups to receive melatonin ( @ mg ) , gabapentin ( @ mg ) or placebo @ min before arrival in the operating room .


Pain , anxiety , and sedation scores during block and surgery as well as the surgeon 's satisfaction with the surgery were assessed .


Anxiety scores decreased significantly in melatonin and gabapentin groups compared to the placebo group after premedication and extended to early postoperative period .


The level of anxiety showed no statistically significant difference between melatonin and gabapentin groups at any time of measurement .


There were significant differences between the pain scores during retrobulbar placement in gabapentin versus placebo ( @ % CI @ to @ ; P = @ ) and melatonin ( @ % CI @ to @ ; P = @ ) groups .


Also , there were significant differences between the sedation scores during retrobulbar placement in gabapentin and placebo groups ( @ % CI @ to @ ; P = @ ) .


The difference in sedation scores during retrobulbar placement in melatonin versus gabapentin and placebo groups was not significant .


Neither the intraoperative pain scores nor the postoperative pain scores were different between the three groups .


The surgeon reported similar quality of operation conditions during surgery for the three study groups .


The level of anxiety was significantly lower with both anxiolytic drugs compared to placebo .


Furthermore , gabapentin decreased the pain and improved the sedation scores only during retrobulbar placement compared to the placebo .


To investigate whether a @-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults .


Randomized controlled trial .


Kyoto , Japan .


Community-dwelling older adults ( N = @ ) were randomized into an exercise group ( n = @ ) and a control group ( n = @ ) .


Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the @-week intervention phase .


Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase .


The outcome measures were global cognitive function , memory function , executive function , and brain activation ( measured using functional magnetic resonance imaging ) associated with visual short-term memory .


Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group ( P < @ ) .


In addition , after the intervention , less activation was found in several brain regions associated with visual short-term memory , including the prefrontal cortex , in the exercise group ( P < @ , uncorrected ) .


A @-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults , which is associated with improvements in memory and executive function .


To explore potential predictors of self-reported paretic arm use at baseline and after task-specific training ( TST ) in survivors of stroke .


Data were obtained from a randomized controlled trial of somatosensory stimulation and upper limb TST in chronic stroke .


University laboratory .


Chronic ( @mo ) survivors of stroke ( N = @ ; mean age , @y ; mean stroke duration , @mo ) .


Participants received @ sessions of TST preceded by either active ( n = @ ) or sham ( n = @ ) somatosensory stimulation to all @ peripheral nerves .


Demographic and clinical characteristics were entered stepwise into multiple linear regression analyses to determine the factors that best predict baseline Motor Activity Log ( MAL ) amount of use rating and change @ months after TST .


The Action Research Arm Test ( ARAT ) score predicted the amount of use at baseline ( R ( @ ) = @ , P < @ ) ; in using this model , an ARAT score of @ ( maximum of @ ) is required to score @ on the MAL ( use described as between rarely and sometimes ) .


After TST the change in the ARAT score predicted the change in the amount of use ( R ( @ ) = @ , P = @ ) .


The predictive power of the model for change at @ months increased if the Fugl-Meyer Assessment wrist component score was added ( R ( @ ) = @ , P = @ ) .


Utilization of the paretic upper limb in activities of daily living requires high functional ability .


The increase in self-reported arm use after TST is dependent on the change in functional ability .


These results provide further guidance for rehabilitation decisions .


There are limited data comparing ultrafiltration with standard medical therapy as first-line treatment in patients with severe congestive heart failure ( HF ) .


We compared ultrafiltration and conventional therapy in patients hospitalized for HF and overt fluid overload .


Fifty-six patients with congestive HF were randomized to receive standard medical therapy ( control group ; n = @ ) or ultrafiltration ( ultrafiltration group ; n = @ ) .


The primary end point of the study was rehospitalizations for congestive HF during a @-year follow-up .


Despite similar body weight reduction at hospital discharge in the @ groups ( @ @ and @ @ kg , respectively ; P = @ ) , a lower incidence of rehospitalizations for HF was observed in the ultrafiltration-treated patients during the following year ( hazard ratio @ , @ % confidence interval @-@ @ ; P = @ ) .


Ultrafiltration-induced benefit was associated with a more stable renal function , unchanged furosemide dose , and lower B-type natriuretic peptide levels .


At @ year , @ deaths ( @ % ) occurred in the ultrafiltration group and @ ( @ % ) in the control group ( P = @ ) .


In HF patients with severe fluid overload , first-line treatment with ultrafiltration is associated with a prolonged clinical stabilization and a greater freedom from rehospitalization for congestive HF .


Pediatric inflammatory bowel disease ( IBD ) is associated with high rates of depression .


This study compared the efficacy of cognitive behavioral therapy ( CBT ) to supportive nondirective therapy ( SNDT ) in treating youth with comorbid IBD and depression .


Youth ( @ % female and @ % male ; age @-@ years , mean age @ years ) with depression and Crohn 's disease ( n = @ ) or ulcerative colitis ( n = @ ) were randomly assigned to a @-month course of CBT or SNDT .


The primary outcome was comparative reduction in depressive symptom severity ; secondary outcomes were depression remission , increase in depression response , and improved health-related adjustment and IBD activity .


A total of @ participants ( @ % ) completed the @-month intervention .


Both psychotherapies resulted in significant reductions in total Children 's Depression Rating Scale Revised score ( @ % for CBT and @ % for SNDT ) , but the difference between the @ treatments was not significant ( p = @ ) .


There were large pre-post effect sizes for each treatment ( d = @ for CBT and d = @ for SNDT ) .


More than @ % of youth had a complete remission of depression at @ months , with no difference between CBT and SNDT ( @ % and @ % , respectively ) .


Compared to SNDT , CBT was associated with a greater reduction in IBD activity ( p = @ ) but no greater improvement on the Clinical Global Assessment Scale ( p = @ ) and health-related quality of life ( IMPACT-III scale ) ( p = @ ) .


This is the first randomized controlled study to suggest improvements in depression severity , global functioning , quality of life , and disease activity in a physically ill pediatric cohort treated with psychotherapy .


Clinical trial registration information-Reducing Depressive Symptoms in Physically Ill Youth ; http://clinical trials.gov ; NCT@ .


The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US , particularly those located in urban areas .


Despite the fact that HIV is often transmitted from one sexual partner to another , most HIV prevention interventions have focused only on individuals , rather than couples .


This five-year study investigates community-based implementation , effectiveness , and sustainability of ` Eban II , ' an evidence-based risk reduction intervention for African-American heterosexual , serodiscordant couples .


This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model ( PCM ) , a model of phased organizational change from exposure to adoption , implementation , and sustainability .


The primary implementation aims are to assist @ community-based organizations ( CBOs ) to implement and sustain Eban II ; specifically , to partner with CBOs to expose providers to the intervention ; facilitate its adoption , implementation and sustainment ; and to evaluate processes and determinants of implementation , effectiveness , fidelity , and sustainment .


The primary effectiveness aim is to evaluate the effect of Eban II on participant ( n = @ couples ) outcomes , specifically incidents of protected sex and proportion of condom use .


We will also determine the cost-effectiveness of implementation , as measured by implementation costs and potential cost savings .


A mixed methods evaluation will examine implementation at the agency level ; staff members from the CBOs will complete baseline measures of organizational context and climate , while key stakeholders will be interviewed periodically throughout implementation .


Effectiveness of Eban II will be assessed using a randomized delayed enrollment ( waitlist ) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up .


Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency - and couples-level characteristics on couples-level outcomes ( e.g. , condom use ) .


This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse , resource-constrained treatment settings .


The incidence of community-acquired methicillin-resistant Staphylococcus aureus infections is rising at an alarming pace .


Effective treatment has historically involved early dbridement and antibiotic administration .


This study was designed to prospectively determine the effectiveness of empiric therapy in treating hand infections .


A prospective randomized trial was conducted at a level I county hospital .


Patients with a hand infection received either empiric intravenous vancomycin at admission or intravenous cefazolin .


Outcomes were tracked using severity of infection , appropriate clinical response , and length of stay .


Cost-effectiveness was calculated using total cost for each patient in both groups .


Statistical analyses were performed .


Forty-six patients were enrolled in the study .


Twenty-four were randomized to cefazolin ( @ percent ) and @ ( @ percent ) to vancomycin .


There was no statistical difference between cost of treatment ( p < @ ) or mean length of stay ( p < @ ) between the groups .


Patients randomized to cefazolin had higher mean costs of treatment compared with patients who were randomized to vancomycin ( p < @ ) .


Patients with more severe infections had more expensive mean costs of treatment ( p < @ ) and longer mean length of stay ( p = @ ) .


Near the end of the study , the incidence of community-acquired methicillin-resistant S. aureus at the authors ' county hospital was discovered to be @ percent , which caused the study to be terminated prematurely by the institutional review board because of the high incidence precluding further randomization .


Appropriate early treatment for methicillin-resistant S. aureus has not been definitively established .


No difference in outcome using cefazolin versus vancomycin as a first-line agent was identified .


Deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling results from endothelial dysfunction and may underlie impaired cardiac relaxation in patients with heart failure with preserved left ventricular ejection fraction ( HFpEF ) and pulmonary hypertension ( PH ) .


The acute hemodynamic effects of riociguat , a novel soluble guanylate cyclase stimulator , were characterized in patients with PH and HFpEF .


Clinically stable patients receiving standard HF therapy with a left ventricular ejection fraction > @ % , mean pulmonary artery pressure ( mPAP ) @ mm Hg , and pulmonary arterial wedge pressure ( PAWP ) > @ mm Hg at rest were randomized to single oral doses of placebo or riociguat ( @ , @ , or @ mg ) .


The primary efficacy variable was the peak decrease in mPAP from baseline up to @ h. Secondary outcomes included hemodynamic and echocardiographic parameters , safety , and pharmacokinetics .


There was no significant change in peak decrease in mPAP with riociguat @ mg ( n = @ ) vs placebo ( n = @ , P = @ ) .


However , riociguat @ mg significantly increased stroke volume ( +@ mL -LSB- @ % CI , @-@ -RSB- ; P = @ ) and decreased systolic BP ( -@ mm Hg -LSB- @ % CI , -@ to -@ -RSB- ; P = @ ) and right ventricular end-diastolic area ( -@ cm@ -LSB- @ % CI , -@ to -@ -RSB- ; P = @ ) , without significantly changing heart rate , PAWP , transpulmonary pressure gradient , or pulmonary vascular resistance .


Riociguat was well tolerated .


In patients with HFpEF and PH , riociguat was well tolerated , had no significant effect on mPAP , and improved exploratory hemodynamic and echocardiographic parameters .


Posttraumatic stress disorder ( PTSD ) is prevalent , persistent , and disabling .


Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials , geographic barriers impede rural veterans from engaging in these evidence-based treatments .


To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD .


The Telemedicine Outreach for PTSD ( TOP ) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses .


Outpatients were recruited from @ Department of Veterans Affairs ( VA ) community-based outpatient clinics serving predominantly rural veterans .


Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale .


Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia , bipolar disorder , or substance dependence .


Two hundred sixty-five veterans were enrolled from November @ , @ , through September @ , @ , randomized to usual care ( UC ) or the TOP intervention , and followed up for @ months .


Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers .


Off-site PTSD care teams included telephone nurse care managers , telephone pharmacists , telepsychologists , and telepsychiatrists .


Nurses conducted care management activities .


Pharmacists reviewed medication histories .


Psychologists delivered cognitive processing therapy via interactive video .


Psychiatrists supervised the team and conducted interactive video psychiatric consultations .


The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale .


Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy .


During the @-month follow-up period , @ of the @ patients randomized to TOP ( @ % ) received cognitive processing therapy compared with @ of @ randomized to UC ( @ % ) ( odds ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


Patients in the TOP arm had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from @ to @ ) compared with those in the UC arm ( from @ to @ ) at @ months ( = -@ ; P = @ ) .


Patients in the TOP arm also had significantly larger decreases in Posttraumatic Diagnostic Scale scores ( from @ to @ ) compared with those in the UC arm ( from @ to @ ) at @ months ( = -@ ; P = @ ) .


There were no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens were not significant .


Attendance at @ or more sessions of cognitive processing therapy significantly predicted improvement in Posttraumatic Diagnostic Scale scores ( = -@ -LSB- @ % CI , -@ to -@ -RSB- ; P = @ ) and fully mediated the intervention effect at @ months .


Telemedicine-based collaborative care can successfully engage rural veterans in evidence-based psychotherapy to improve PTSD outcomes .


Pregnancy is a recognised high risk period for excessive weight gain , contributing to postpartum weight retention and obesity development long-term .


We aimed to reduce postpartum weight retention following a low-intensity , self-management intervention integrated with routine antenatal care during pregnancy .


@ women at increased risk of gestational diabetes , < @ weeks gestation were randomised to intervention ( @ self-management sessions ) or control ( generic health information ) .


Outcomes , collected at baseline and @ weeks postpartum , included anthropometrics ( weight and height ) , physical activity ( pedometer ) and questionnaires ( health behaviours ) .


Mean age ( @ and @ years ) and body mass index ( @ and @ kg/m@ ) were similar between intervention and control groups , respectively at baseline .


By @ weeks postpartum , weight change in the control group was significantly higher than the intervention group with a between group difference of @ kg ( @ % CI : -@ , -@ ; p < @ ) overall , with a greater difference in weight found in overweight , but not obese women .


Intervention group allocation , higher baseline BMI , GDM diagnosis , country of birth and higher age were all independent predictors of lower weight retention at @ weeks postpartum on multivariable linear regression .


Other factors related to weight including physical activity , did not differ between groups .


A low intensity intervention , integrated with standard antenatal care is effective in limiting postpartum weight retention .


Implementation research is now required for scale-up to optimise antenatal health care .


Categorization of colon cancers into distinct subtypes using a combination of pathway-based biomarkers could provide insight into stage-independent variability in outcomes .


We used a polymerase chain reaction-based assay to detect mutations in BRAF ( V@E ) and in KRAS in @ stage III cancer samples , collected prospectively from patients participating in an adjuvant chemotherapy trial ( NCCTG N@ ) .


Tumors deficient or proficient in DNA mismatch repair ( MMR ) were identified based on detection of MLH@ , MSH@ , and MSH@ proteins and methylation of the MLH@ promoter .


Findings were validated using tumor samples from a separate set of patients with stage III cancer ( n = @ ) .


Association with @-year disease-free survival was evaluated using Cox proportional hazards models .


Tumors were categorized into @ subtypes based on MMR status and detection of BRAF or KRAS mutations which were mutually exclusive .


Three subtypes were MMR proficient : those with mutations in BRAF ( @ % of samples ) , mutations in KRAS ( @ % ) , or tumors lacking either BRAF or KRAS mutations ( @ % ) .


Two subtypes were MMR deficient : the sporadic type ( @ % ) with BRAF mutation and/or or hypermethylation of MLH@ and the familial type ( @ % ) , which lacked BRAF ( V@E ) or hypermethylation of MLH@ .


A higher percentage of MMR-proficient tumors with BRAF ( V@E ) were proximal ( @ % ) , high-grade ( @ % ) , N@ stage ( @ % ) , and detected in women ( @ % ) , compared with MMR-proficient tumors without BRAF ( V@E ) or KRAS mutations ( @ % , @ % , @ % , and @ % , respectively ; all P < @ ) .


A significantly lower proportion of patients with MMR-proficient tumors with mutant BRAF ( hazard ratio = @ ; @ % confidence interval : @-@ @ ; Padjusted = @ ) or mutant KRAS ( hazard ratio = @ ; @ % confidence interval : @-@ @ ; Padjusted < @ ) survived disease-free for @ years compared with patients whose MMR-proficient tumors lacked mutations in either gene .


Disease-free survival rates of patients with MMR-deficient sporadic or familial subtypes was similar to those of patients with MMR-proficient tumors without BRAF or KRAS mutations .


The observed differences in survival rates of patients with different tumor subtypes were validated in an independent cohort .


We identified subtypes of stage III colon cancer , based on detection of mutations in BRAF ( V@E ) or KRAS , and MMR status that show differences in clinical and pathologic features and disease-free survival .


Patients with MMR-proficient tumors and BRAF or KRAS mutations had statistically shorter survival times than patients whose tumors lacked these mutations .


The tumor subtype found in nearly half of the study cohort ( MMR-proficient without BRAF ( V@E ) or KRAS mutations ) had similar outcomes to those of patients with MMR-deficient cancers .


This paper is embedded in a randomised controlled trial ( Alcohol and Employment ) that investigated whether welfare-to-work schemes combined with alcohol treatment were more effective than welfare-to-work schemes alone for helping unemployed welfare recipients with alcohol problems get back to employment and reduce their alcohol problems .


The implementation of Alcohol and Employment turned out to be challenging , and fewer welfare recipients than expected were enrolled .


The aim of this paper was to identify and investigate obstacles to the implementation of Alcohol and Employment .


Our main objective was to study the job consultants ' role in the implementation process as they were key personnel in conducting the trial .


The process evaluation was conducted in four Danish municipalities in @-@ .


Data for identifying factors important for the implementation were collected through observations and focus group interviews with job consultants .


Data were analysed thematically and thoroughly discussed among members of the project team ; emerging themes were then grouped and read again repeatedly until the themes were consistent .


Three themes emerged as the main factors influencing the degree of implementation of Alcohol and Employment : ( @ ) The job consultants ' personal attitudes toward alcohol were an important factor .


The job consultants generally did not consider a high alcohol intake to be an impediment to employment , or they thought that alcohol problems were only symptoms of more profound problems .


( @ ) The job consultants ' perception of their own roles and responsibilities in relation to the welfare recipients was a barrier : they felt that addressing alcohol problems and at the same time sustaining trust with the welfare recipient was difficult .


Also , they did not consider alcohol problems to be their responsibility .


( @ ) Shortage of time and resources among the job consultants was determined to be an influential factor .


We identified important factors at the individual level among the job consultants who threatened the implementation of Alcohol and Employment .


Future studies in similar settings can take advantage of these findings when preparing interventions that are implemented by job consultants or similar professionals .


We designed a continuing medical education ( CME ) program to teach primary care physicians ( PCP ) how to engage in cancer risk communication and shared decision making with patients who have limited health literacy ( HL ) .


We evaluated whether training PCPs , in addition to audit-feedback , improves their communication behaviors and increases cancer screening among patients with limited HL to a greater extent than only providing clinical performance feedback .


Four-year cluster randomized controlled trial .


Eighteen PCPs and @ patients with limited HL who were overdue for colorectal/breast/cervical cancer screening .


Communication intervention PCPs received skills training that included standardized patient ( SP ) feedback on counseling behaviors .


All PCPs underwent chart audits of patients ' screening status semiannually up to @ months and received two annual performance feedback reports .


PCPs experienced three unannounced SP encounters during which SPs rated PCP communication behaviors .


We examined between-group differences in changes in SP ratings and patient knowledge of cancer screening guidelines over @ months ; and changes in patient cancer screening rates over @ months .


There were no group differences in SP ratings of physician communication at baseline .


At follow-up , communication intervention PCPs were rated higher in general communication about cancer risks and shared decision making related to colorectal cancer screening compared to PCPs who only received performance feedback .


Screening rates increased among patients of PCPs in both groups ; however , there were no between-group differences in screening rates except for mammography .


The communication intervention did not improve patient cancer screening knowledge .


Compared to audit and feedback alone , including PCP communication training increases PCP patient-centered counseling behaviors , but not cancer screening among patients with limited HL .


Larger studies must be conducted to determine whether lack of changes in cancer screening were due to clinic/patient sample size versus ineffectiveness of communication training to change outcomes .


To investigate the safety and short term outcome of high dose recombinant human erythropoietin ( rhEpo ) given shortly after birth and subsequently over the first @ days for neuroprotection to very preterm infants .


Randomized , double masked phase II trial .


Preterm infants ( gestational age @@/@ -@ @/@ weeks ) were given rhEpo ( nt = @ ; @ U/kg body weight ) or NaCl @ % ( nc = @ ) intravenously at @ , @-@ , and @-@ hours after birth .


There were no relevant differences between the groups for short-term outcomes such as mortality , retinopathy of prematurity , intraventricular hemorrhage , sepsis , necrotizing enterocolitis , and bronchopulmonary dysplasia .


At day @-@ , we found significantly higher hematocrit values , reticulocyte , and white blood cell counts , and a lower platelet count in the rhEpo group .


Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events .


Delayed graft function , which is reported in up to @ % of kidney-transplant recipients , is associated with increased costs and diminished long-term graft function .


The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear .


We enrolled organ donors ( after declaration of death according to neurologic criteria ) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges : @ to @C ( hypothermia ) or @ to @ C ( normothermia ) .


Temperature protocols , which were initiated after authorization was obtained for the organ to be donated and for the donor 's participation in the study , ended when organ donors left the intensive care unit for organ recovery in the operating room .


The primary outcome was delayed graft function in the kidney recipients , which was defined as the requirement for dialysis during the first week after transplantation .


Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor .


The study was terminated early , on the recommendation of an independent data and safety monitoring board , after the interim analysis showed efficacy of hypothermia .


At trial termination , @ organ donors had been enrolled ( @ in the hypothermia group and @ in the normothermia group ) .


A total of @ patients received a kidney transplant ( @ kidneys from donors in the hypothermia group and @ kidneys from donors in the normothermia group ) .


Delayed graft function developed in @ recipients of kidneys from donors in the hypothermia group ( @ % ) and in @ recipients of kidneys from donors in the normothermia group ( @ % ) ( odds ratio , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Mild hypothermia , as compared with normothermia , in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients .


( Funded by the Health Resources and Services Administration ; ClinicalTrials.gov number , NCT@ . )


Antipsychotics are commonly used for management of behavioural symptoms in dementia , among people in residential care .


This continues to occur despite their modest effectiveness , potential harms including increased risk of death and stroke , and absence of detrimental effect when people with dementia were randomised to antipsychotic withdrawal .


This study aims to test the hypothesis that the multifaceted REducing Anti-Psychotic use in residential care-Huntington Disease ( REAP-HD ) programme is more effective than standard staff education ( SSE ) in reducing antipsychotic use for people with HD in residential care facilities ( RCF ) .


this is a cluster randomised controlled trial with blinded outcome assessment .


The study population is healthcare professionals looking after people with HD in individual RCF , in the state of New South Wales .


Each RCF will be centrally randomised to the REAP-HD programme or the comparator , SSE .


Blinded outcome assessment will be performed by examining drug charts and using the Neuropsychiatric Inventory-Q ( NPI-Q ) .


Primary outcome is the proportion of people with HD who have had a reduction in antipsychotic use @ months after the intervention .


Secondary outcome measures are ( @ ) change in severity of behavioural symptoms , as measured by the NPI-Q at @ months ( to ensure antipsychotic reduction has not lead to worsening behavioural symptoms ) , and ( @ ) proportion of people with HD who have had a reduction in antipsychotic dosage at @ months for each strategy , compared to @ months prior to enrolment ( to capture the possibility that both arms reduced antipsychotic use ) .


Analysis will be by Intention-To-Treat and take into account the clustering .


Recruitment is ongoing , as of July @ .


The objective of this study was to investigate the association of spirometry and pulmonary CT biomarkers with cardiovascular events .


In this lung cancer screening trial @,@ male participants without a prior cardiovascular event were analysed .


Fatal and non-fatal cardiovascular events were included .


Spirometry included forced expiratory volume measured in units of one-second percent predicted ( FEV@ % predicted ) and FEV@ divided by forced vital capacity ( FVC ; FEV@/FVC ) .


CT examinations were quantified for coronary artery calcium volume , pulmonary emphysema ( perc@ ) and bronchial wall thickness ( pi@ ) .


Data were analysed via a Cox proportional hazard analysis , net reclassification improvement ( NRI ) and C-indices .


@ participants experienced a cardiovascular event during a median follow-up of @ years .


Age , pack-years and smoking status adjusted hazard ratios were @ ( @ % confidence interval ( CI ) @-@ @ ) for FEV@ % predicted , @ ( @ % CI @-@ @ ) for FEV@/FVC , @ ( @ % CI @-@ @ ) for perc@ per @ HU , and @ ( @ % CI @-@ @ ) for pi@ per @ mm .


The incremental C-index ( < @ ) and NRI ( < @ % ) were minimal .


Coronary artery calcium volume had a hazard ratio of @ ( @ % CI @-@ @ ) per @ mm ( @ ) , an increase in C-index of @ and an NRI of @ % ( P < @ ) .


Pulmonary CT biomarkers and spirometry measurements were significantly associated with cardiovascular events , but did not contain clinically relevant independent prognostic information for cardiovascular events .


Pulmonary CT biomarkers and spirometry are associated with cardiovascular events These pulmonary measurements do not contain clinically relevant independent prognostic information Only coronary calcium score improved cardiovascular risk prediction above age and smoking .


Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence .


The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge .


This is a baseline survey of a cluster-randomized controlled trial in @ general practices with an educational intervention for patients or their caregivers .


We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety precautions of @ patients at baseline .


Participants rated their knowledge about OAT as excellent to good ( @ % ) , moderate ( @ % ) or poor ( @ % ) .


However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps .


Half of the participants ( @ % ) were unaware of dietary recommendations .


The majority ( @ % ) did not know which non-prescription analgesic is the safest and @ % indicated they would not inform pharmacists about OAT .


Many participants ( @-@ % ) would not recognize important emergency situations .


After adjustment in a multivariate analysis , older age and less than @ years education remained significantly associated with lower overall score , but not with self-rated knowledge .


Patients have relevant knowledge gaps , potentially affecting safe and effective OAT .


There is a need to assess patient knowledge and for structured education programs .


The optimal second-line regimen for treating advanced gastric cancer ( AGC ) remains unclear .


While irinotecan ( CPT-@ ) plus cisplatin ( CDDP ) combination therapy and CPT-@ monotherapy have been explored in the second-line setting , the superiority of second-line platinum-based therapies for AGC patients initially treated with S-@ monotherapy has not yet been evaluated ; therefore , we aimed to examine the survival benefit of CPT-@ / CDDP combination over CPT-@ monotherapy .


AGC patients showing progression after S-@ monotherapy for advanced cancer or recurrence within @ months after completion of S-@ adjuvant therapy were randomly allocated to CPT-@ / CDDP ( CPT-@ , @ mg/m ( @ ) ; CDDP , @ mg/m ( @ ) , q@w ) or CPT-@ ( @ mg/m ( @ ) , q@w ) .


Sixty-eight advanced and @ recurrent cases were evaluated .


The median overall survivals were @ ( @ % confidence interval -LSB- CI -RSB- : @-@ @ ) and @ ( @ % CI : @-@ @ ) months for CPT-@ / CDDP and CPT-@ , respectively ( hazard ratio : @ ; @ % CI : @-@ @ , P = @ ) .


No significant differences were observed in the secondary end-points , including progression-free survival ( @ -LSB- @ % CI : @-@ @ -RSB- versus @ -LSB- @ % CI : @-@ @ -RSB- months ) and response rate ( @ % -LSB- @ % CI : @-@ @ -RSB- versus @ % -LSB- @ % CI : @-@ @ -RSB- ) .


The incidences of grade @-@ anaemia ( @ % versus @ % ) and elevated serum lactate dehydrogenase levels ( @ % versus @ % ) were higher for CPT-@ / CDDP than for CPT-@ .


Exploratory subgroup analysis revealed that CPT-@ / CDDP was significantly more effective for intestinal-type AGC , compared with CPT-@ ( overall survival : @ versus @ months ; P = @ ) .


No survival benefit was observed upon adding CDDP to CPT-@ after S-@ monotherapy failure .


Postoperative delirium is the most common postoperative complication in the elderly .


The purpose of this study was to evaluate the safety and effectiveness of the preventive administration of low-dose haloperidol on the development of postoperative delirium after abdominal or orthopedic surgery in elderly patients .


A total of @ patients aged @ years or older who underwent elective surgery for digestive or orthopedic disease were included in this study .


Patients were divided into those who did ( intervention group , n = @ ) and did not ( control group , n = @ ) receive @ mg of haloperidol at @:@ daily for @ days after surgery ; a randomized , open-label prospective study was performed on these groups .


The primary endpoint was the incidence of postoperative delirium during the first @ days after the operation .


The incidence of postoperative delirium in all patients was @ % .


No side effects involving haloperidol were noted ; however , the incidences of postoperative delirium were @ and @ % in the intervention and control groups , respectively , which were not significantly different ( p = @ ) .


No significant effect of the treatment was observed on the severity or persistence of postoperative delirium .


The preventive administration of low-dose haloperidol did not induce any adverse events , but also did not significantly decrease the incidence or severity of postoperative delirium or shorten its persistence .


There are insufficient data to guide perioperative implantable cardioverter-defibrillator ( ICD ) management for patients undergoing surgical procedures using electrocautery .


We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery .


Subjects were randomized to an `` Off '' group ( ICD therapy programmed off , then postoperatively programmed on ) or a `` Magnet '' group ( ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation ) .


Also , a registry was maintained of ICD patients with procedures within @ inches of the ICD ( all programmed off ) .


The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference ( EMI ) .


All patients ( n = @ ) had pectoral ICDs .


Subject demographics were well matched in each group , and duration of electrocautery was similar ( @ minutes vs @ minutes , P = @ ) .


The mean `` excess '' ICD off time ( ICD off time - electrocautery time ) was significantly higher in the Off group than the Magnet group ( @ minutes vs @ minutes , P < @ ) .


Mean number of caregiver handoffs were higher in the Off group ( @ vs @ , P < @ ) .


There was no EMI in any lower abdominal or lower extremity procedures .


Neither group had arrhythmic events or device reset .


A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than @ inches from the ICD .


This protocol results in significantly shorter time with ICD therapy off , fewer provider handoffs , no risk of inadvertently discharging patients home with ICD therapies off , and no device reset .


This phase @ study examined the efficacy and tolerability of edivoxetine , a highly selective norepinephrine reuptake inhibitor , as an adjunctive treatment for patients with major depressive disorder ( MDD ) who have a partial response to selective serotonin reuptake inhibitor ( SSRI ) treatment .


Study design consisted of double-blind , @-week therapy of adjunctive edivoxetine ( @-@ mg once daily ) or adjunctive placebo with SSRI .


Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID @-item Hamilton Rating Scale for Depression ( HAMD@ ) total score @ .


The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale ( MADRS ) .


Safety measures included treatment-emergent adverse events ( TEAE ) and vital signs .


For the primary evaluable population ( n = @ for adjunctive edivoxetine and n = @ for adjunctive placebo ) , the treatment groups did not differ significantly on the primary outcome of change from baseline to week @ in the MADRS total score ; the effect size of edivoxetine treatment was @ .


Significant treatment differences , favoring adjunctive edivoxetine ( p. @ ) , were shown for improvements in role functioning and the functional impact of fatigue .


For the adjunctive edivoxetine randomized group ( N = @ ) , the most frequent TEAEs were hyperhidrosis ( @ % ) , nausea ( @ % ) , erectile dysfunction ( @ % ) and testicular pain ( @ % ) .


Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups .


Study was underpowered for an alpha @-sided @ significance level for the primary outcome .


For patients with MDD who had a partial response to SSRIs , adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure .


However , pending further study , improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression .


We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme .


We undertook a cluster randomized controlled trial of @ students aged @-@ years in @ secondary schools located in Reggio Emilia , Italy .


The intervention consisted of the `` Smoking Prevention Tour '' ( SPT ) out-of-school workshop , one in-depth lesson on one Smoking Prevention Tour topic , a life-skills peer-led intervention , and enforcement surveillance of school antismoking policy .


Self-reported past @-day smoking of @ or @-@ days of cigarette smoking ( daily or frequent smoking , respectively ) was recorded in @ surveys administered immediately before and @ months after the beginning of the programme .


Analysis was by intention to treat .


The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses .


Past @-day smoking and daily cigarette use at eighteen months follow-up were @ % and @ % lower , respectively , for intervention students compared to control students .


Taking into account non-smokers at baseline only , daily smoking at eighteen months follow-up was @ % lower in intervention students than in controls .


Past @-day smoking in school areas was @ % lower in intervention students compared to controls .


The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas .


To assess the efficacy of dapagliflozin , a sodium-glucose cotransporter @ inhibitor , for the treatment of individuals with type @ diabetes mellitus ( T@DM ) and preexisting cardiovascular disease ( CVD ) .


Randomized , double-blind , age-stratified ( < @ and @ ) , @-week clinical trial with a @-week extension .


One hundred seventy-three centers in @ countries .


Individuals ( N = @ ) with T@DM , glycosylated hemoglobin ( HbA@c ) of @ % to @ % , and documented CVD .


Dapagliflozin @ mg/d or placebo was added to usual care .


Participants receiving insulin had their total daily insulin dose reduced by @ % at randomization .


Two equal primary end points : change from baseline in HbA@c and proportion of participants achieving a three-item end point ( reduction of @ % in HbA@c , @ % in body weight , and @ mmHg in systolic blood pressure ) at @ weeks .


Forty-seven percent were aged @ and older , @ % were aged @ and older , mean duration of T@DM was @ years , mean baseline HbA@c was @ % , and approximately @ % were taking insulin .


The placebo-corrected change in HbA@c with dapagliflozin was -@ % at @ weeks .


Significantly more participants achieved the three-item end point with dapagliflozin ( @ % ) than with placebo ( @ % ) .


The placebo-corrected percentage change in body weight for dapagliflozin was -@ % ( -@ kg ) .


Similar results were observed in both age strata , and changes were maintained over @ weeks .


More than one-quarter ( @ % ) of participants receiving dapagliflozin and @ % of those receiving placebo experienced hypoglycemia .


More participants receiving dapagliflozin had vulvovaginitis , balanitis , or urinary tract infection .


When added to a usual background regimen in an older population with advanced T@DM and preexisting comorbid CVD , dapagliflozin improved glycemic control without an increase in hypoglycemic risk , promoted weight loss , and was well tolerated .


A recent international , multicenter , double-blinded , randomized trial shows delayed-enhanced magnetic resonance imaging ( DE-MRI ) using contrast doses of @ mmol/kg is effective in the detection and assessment of myocardial infarction ( MI ) , and @ mmol/kg is not enough ; intermediate doses between @ and @ mmol/kg have not been tested .


The aim of this study was to prospectively test the performance of DE-MRI using @ mmol/kg of contrast agent for the detection of MI .


A total of @ consecutive patients with chronic MI underwent DE-MRI at @ T using both @ mmol/kg and @ mmol/kg of contrast agent in random order and on separate days .


Infarction segment and infarction size were compared on DE-MRI images using a @-segment model .


Bland-Altman analysis was used to analyze correlation and agreement between global infarct sizes .


DE-MRI showed enhanced myocardium in all the @ patients with chronic MI .


There was no significant difference between the @ mmol/kg and @ mmol/kg images in all @ patients based on the infarction segment ( @ vs. @ , respectively ; p = @ ) .


There was no significant difference between the infarction size obtained from @ mmol/kg acquisition and that from @ mmol/kg acquisition ( @ % vs. @ % , respectively ; p = @ ) .


A strong correlation between the infarction size obtained from @ mmol/kg acquisition and that from @ mmol/kg acquisition was indicated through Bland-Altman analysis .


DE-MRI at @ T using @ mmol/kg of contrast agent is effective for the assessment of MI .


A sudden gain is defined as a large and stable individual improvement occurring between two consecutive treatment sessions .


Sudden gains have been shown to predict better long-term improvement in several treatment studies , including cognitive behavioural therapy for depression and anxiety disorders , but have not been studied in the treatment of health anxiety or any form of internet-based cognitive behavioural therapy .


The aim of this study was to investigate the role of sudden gains in internet-based cognitive behavioural therapy for severe health anxiety .


We examined the occurrence and significance of sudden gains in measures of health anxiety in @ participants receiving internet-based cognitive behavioural therapy .


We compared patients with sudden gains , patients without sudden gains , and patients with gradual gains .


Thirteen participants ( @ % ) experienced one sudden gain in health anxiety with individual sudden gains distributed across the treatment .


As expected , patients with a sudden gain showed larger improvements than patients without a sudden gain at post-treatment ( d = @ ) and at one-year follow-up ( d = @ ) on measures of health anxiety .


Consistent with previous studies , sudden gains in internet-based cognitive behavioural therapy are associated with significantly larger and stable treatment effects up to one-year follow-up .


Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers .


Internet-based mental health interventions have the potential to be more engaging and accessible to young adults compared to those delivered face-to-face .


However , they are rarely inclusive of lesbian women and gay men .


Thus , the current study aims to evaluate the effectiveness of an online mental health and wellbeing program , Out & Online ( http://www.outandonline.org.au ) , in comparison to a wait-list control group , for reducing anxiety and depressive symptoms in same-sex attracted young adults aged between @ and @ years .


We are recruiting , through media and community organisations , @ same-sex attracted young adults with anxiety and/or depressive symptoms and mild to moderate psychological distress ( Kessler-@ score between @ to @ ) .


Participants will be randomly allocated to the intervention ( the online program ) or the wait-list control group based on a permuted blocked randomisation method to allow for stratification by gender .


Participants in the intervention group will receive a tailored program for up to three types of mental health difficulties simultaneously .


The primary outcome of anxiety and/or depressive symptoms , and secondary outcomes related to psychological distress , wellbeing and health behaviour will be measured at pre-intervention ( @ week ) , post-intervention ( @ weeks ) and at a @-month follow-up ( @ weeks ) .


This online mental health and wellbeing program will be one of the first online interventions to be designed specifically to be relevant for same-sex attracted individuals .


If the program is found to be effective it will improve access to specialist same-sex attracted-relevant mental health services for young adults and will facilitate wellbeing outcomes for these individuals .


This program will also be a significant development in the delivery of tailored interventions that target multiple types of mental health conditions simultaneously .


Endometriosis affects fertility negatively .


The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis .


A randomized controlled trial ( RCT ) was conducted in @ infertile women with minimal/mild endometriosis .


After laparoscopic surgery , patients were randomized to three groups : in Group A ( n = @ ) oral contraceptive ( OC ) was administered one pill a day , continuous for @days without intervals , in Group B ( n = @ ) OC was administered as above and then Dan ' e mixture was added @g/day for the latter @days , and in control Group C ( n = @ ) patients tried to get pregnant after surgery without complementary treatment .


The follow-up periods were @months in Group C and @months in complementary medical treatment Group A and B.


The pregnant women were further followed up , and labor and pregnancy outcomes were assessed .


Primary outcome was pregnancy rate ( PR ) and live birth rate ( LBR ) .


Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects .


Analyses were done as intention-to-treat .


The PR was @ % ( @/@ ) , and the LBR was @ % ( @/@ ) .


Of the @ pregnancies , @ occurred within @months of follow-up and @ of the remaining @ patients underwent assisted reproductive technology for > @year .


No significant difference was observed in PR and LBR among the three groups .


Patients given medical treatment ( OCs or OCs plus herbal medicine ) had significantly decreased pain scores compared with the laparoscopy alone group .


Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis .


To explore the effect of continuous nursing intervention guided by chronotherapeutics so as to provide the easy , noninvasive , effective and acceptable intervention for older hypertensive patients in the community .


Many researchers studied the effect of administration at different times on blood pressure control and circadian rhythm .


However , the individual administrative time was set ambiguously in previous studies .


A semi-experimental study .


In the study , @ eligible patients were recruited and separated into three groups randomly , which were the control group , intervention group A ( behaviour and chronotherapy intervention ) and intervention group B ( behaviour intervention ) .


At @ and @months after the study , the intervention groups were measured @-hour ambulatory blood pressure monitoring .


There were significant differences in ambulatory blood pressure monitoring parameters of the two intervention groups at different measurement times , and there were interaction between measurement time and different groups .


The number of patients with dipper increased and reverse dipper decreased in group A as the intervention applied .


There were statistical differences between two groups .


The number of patients with morning surge in group A decreased more , and there were statistical differences between two groups at six months after the intervention .


The behaviour and chronotherapy intervention based on the patients ' ambulatory blood pressure monitoring can control casual blood pressure much better and last longer , which can also improve patients ' indexes of ambulatory blood pressure monitoring better than behaviour intervention only .


The behaviour and chronotherapy intervention can increase patients ' nocturnal blood pressure drop , increase the number of patients with dipper and decrease reverse dipper , and improve blood pressure surge in the morning .


Nurses can use continuous nursing intervention guided by chronotherapeutics to help improve hypertension of older patients better in the community .


To test the impact of the method of administration ( MOA ) on score level , reliability , and validity of scales developed in the Patient Reported Outcomes Measurement Information System ( PROMIS ) .


Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks ( Physical Function , Fatigue , and Depression ) were completed by @ adults with chronic obstructive pulmonary disease , depression , or rheumatoid arthritis .


In a randomized crossover design , subjects answered one form by interactive voice response ( IVR ) technology , paper questionnaire ( PQ ) , personal digital assistant ( PDA ) , or personal computer ( PC ) and a second form by PC , in the same administration .


Method equivalence was evaluated through analyses of difference scores , intraclass correlations ( ICCs ) , and convergent/discriminant validity .


In difference score analyses , no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of @ standard deviation .


Parallel-forms reliabilities were very high ( ICC = @-@ @ ) .


Only one across-mode ICC was significantly lower than the same-mode ICC .


Tests of validity showed no differential effect by MOA .


Participants preferred screen interface over PQ and IVR .


We found no statistically or clinically significant differences in score levels or psychometric properties of IVR , PQ , or PDA administration compared with PC .


Prospective randomized study .


This study aimed to prospectively compare the surgical results of the open - and French-door laminoplasty .


Cervical laminoplasty is a common surgical procedure for the treatment of cervical compressive myelopathy .


These procedures are primarily classified as either open - or French-door laminoplasties .


Only few prospective studies comparing the surgical results of the @ procedures are available .


A total of @ patients with cervical compressive myelopathy who underwent cervical laminoplasty were prospectively enrolled and randomized into the following @ groups according to the type of laminoplasty : open-door and French-door groups .


A single attending spine surgeon performed all surgical procedures .


The following factors were evaluated : surgical duration , blood loss , perioperative complications , neurological assessment using the Japanese Orthopedic Association score , and recovery rate .


Radiological evaluations included assessment of the cervical lordotic angle and cervical range of motion .


In addition , the ratio of postoperative spinal lamina opening was evaluated by magnetic resonance imaging .


There were no differences in perioperative complications and neurological outcomes between the @ groups .


The mean reduction in cervical lordotic angle after surgery was significantly greater in the open-door group than the French-door group ( @ vs. @ ) .


Postoperative cervical range of motion significantly decreased in the open-door group than in the French-door group ( @ vs. @ ) .


Postoperative cervical lordotic angle in the extension position significantly diminished in the open-door group than in the French-door group ( @ vs. @ ) .


The ratio of opening of the spinal lamina after surgery was significantly larger in the open-door group than in the French-door group .


The @ laminoplasty methods showed almost the same neurological recovery as well as perioperative complications .


In cases of open-door laminoplasty , postoperative cervical alignment became more kyphotic and cervical range of motion was more restricted than that in French-door laminoplasty cases after surgery .


French-door laminoplasty is preferable to open-door laminoplasty for postoperative cervical alignments .


Burnout is a very prevalent type of stress among health professionals .


It affects their well-being , performance , and attitude toward patients .


This study assessed the effectiveness of a training program for primary health care professionals designed to reduce burnout and mood disturbance , increase empathy , and develop mindfulness .


Pragmatic randomized controlled trial with pre - and postintervention measurements of @ primary health care professionals ( @ in the intervention and @ in the control group ) in Spain .


The intervention consisted of presentations of clinically relevant topics , mindfulness-based coping strategies , mindfulness practice , yoga , and group discussions ( @ sessions of @ hours per week plus a @-day session of @ hours ) .


Outcome measures included the Maslach Burnout Inventory , Profile of Mood States , Jefferson Scale of Physician Empathy , Baer 's Five Facets Mindfulness Questionnaire , and a questionnaire on changes in personal habits and mindfulness practice .


Measurements were performed at baseline and after @ weeks .


The intervention group improved in the @ scales measured .


The magnitude of the change was large in total mood disturbance ( difference between groups -@ ; standardized effect-size -LSB- SES -RSB- @ ) and mindfulness ( difference between groups @ ; SES @ ) and moderate in the burnout ( difference between groups -@ ; SES @ ) and empathy scales ( difference between groups @ ; SES @ ) .


No significant differences were found in the control group .


Our study supports the use of mindfulness-based programs as part of continuing professional education to reduce and prevent burnout , promote positive attitudes among health professionals , strengthen patient-provider relationships , and enhance well-being .


Anogenital warts are a common disorder associated with significant physical and mental distress and a substantial cause of health care costs .


To assess the efficacy of the topical application of nitric oxide delivered using acidified nitrite .


A multicenter , randomized , controlled , dose-ranging clinical trial was conducted in European genitourinary medicine clinics between December @ , @ , and January @ , @ .


Analysis was by intent to treat for all individuals initiating therapy .


Participants included male and female volunteers older than @ years with between @ and @ external anogenital warts .


A total of @ individuals from @ centers were randomized to a control arm and a treatment arm that received @ doses of acidified nitrite applied topically for @ weeks with an additional @ weeks of follow-up , with the final follow-up visit on January @ , @ .


Placebo nitrite cream and placebo citric acid cream were applied twice daily .


Active treatment was divided as low dose ( sodium nitrite , @ % , with citric acid , @ % , creams applied twice daily ) , middle dose ( sodium nitrite , @ % , with citric acid , @ % , creams applied once daily at night , with placebo applied in the morning ) , and high dose ( sodium nitrite , @ % , with citric acid , @ % , creams applied twice daily ) .


The primary outcome was proportion of patients with complete clinical clearance of target warts ; secondary outcomes were reduction in target wart area and safety .


Complete clinical clearance at @ weeks occurred in @ of @ patients ( @ % ; @ % CI , @ % -@ % ) with placebo ; @ of @ ( @ % ; @ % CI , @ % -@ % ) with low-dose treatment ; @ of @ ( @ % ; @ % CI , @ % -@ % ) with middle-dose treatment ; and @ of @ ( @ % ; @ % CI , @ % -@ % ) with high-dose treatment ( P = @ ) .


Reduction in target wart area , time to clearance , and patient and investigator assessments supported the superiority of the high-dose therapy vs placebo .


There were no systemic or serious adverse events associated with treatment .


However , there was a dose-related increase in itching , pain , edema , and staining of the anogenital skin associated with the active treatment .


Overall , @ patients withdrew from active treatment because of adverse events compared with none using placebo .


Use of sodium nitrite , @ % , with citric acid , @ % , twice daily is more effective than placebo in the treatment of anogenital warts .


Treatment was associated with local irritant adverse effects .


Noncardiac chest pain ( NCCP ) is seen more frequently in young population and in these patients loss of function is evolving in social and professional areas .


The aim of the study is to evaluate the levels of anxiety and somatic perception in patients with chest pain presenting to cardiology clinic .


Fifty-one patients with noncardiac chest pain and @ healthy controls were included in the study .


All participants performed self-report based health anxiety inventory ( HAI ) , somatosensory amplification scale ( SAS ) , and Toronto alexithymia scale ( TAS ) .


The patient group had significantly higher scores on the SAS , HAI-@ , and HAI-T scales compared to controls ( P < @ , P = @ , and P = @ , resp . )


SAS , HAI-@ , and HAI-T scores were significantly higher in female patients than male ( P = @ , @ , and @ , resp . )


There were significant differences in all TAS subscale scores between two groups .


Patients , who had total TAS score more than @ , also presented higher levels of health anxiety ( P = @ ) .


Anxiety , somatic symptoms , and the exaggerated sense of bodily sensations are common in patients with NCCP .


These patients unnecessarily occupy the cardiology outpatient clinics .


These negative results can be eliminated when consultation-liaison psychiatry evaluates these patients in collaboration with cardiology departments .


To compare the differences in the clinical efficacy on Alzheimer 's disease between acupuncture and medicine .


One hundred and forty-one patients were randomized into an acupuncture group ( @ cases ) and a medicine group ( @ cases ) .


In the acupuncture group , the needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence was used at Shenting ( GV @ ) , Baihui ( GV @ ) , Fengchi ( GB @ ) , Wangu ( GB @ ) , Danzhong ( CV @ ) , Zhangwan ( CV @ ) , Qihai ( CV @ ) , Xuehai ( SP @ ) and Zusanli ( ST @ ) .


The supplementary acupoints were selected according to the symptoms and physical signs .


Acupuncture was given once a day and @ treatments were required for a week .


In the medicine group , the choline sterase inhibitor , donepezil ( aricept ) was prescribed for oral administration , @ tablet ( @ mg ) each time , once every night .


Four weeks later , the dose was increased to @ tablets ( @ mg ) each time .


In the two groups , the treatment of @ weeks made one session and @ sessions were required .


The changes of scores before and after treatment in the minimum mental state examination ( MMSE ) , the activity of daily living scale ( ADL ) , Alzheimer 's disease assessment scale-cognition ( ADAS-cog ) and the digit span ( DS ) were observed .


After treatment , scores of MMSE and DS were increased as compared with those before treatment ( both P < @ ) and scores of ADL and ADAS-cog were reduced as compared with those before treatment .


The score differences in MMSE , ADL , ADAS-cog and DS before and after treatment were significant in the two groups ( all P < @ ) .


The needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence significantly improves the overall function , cognition and activity of daily life in the patients of Alzheimer 's disease and the efficacy is better than donepezil .


There is little evidence available on the use of robot-assisted therapy in subacute stroke patients .


A randomized controlled trial was carried out to evaluate the short-time efficacy of intensive robot-assisted therapy compared to usual physical therapy performed in the early phase after stroke onset .


Fifty-three subacute stroke patients at their first-ever stroke were enrolled @days after the acute event and randomized into two groups , both exposed to standard therapy .


Additional @ sessions of robot-assisted therapy were provided to the Experimental Group .


Additional @ sessions of usual therapy were provided to the Control Group.The following impairment evaluations were performed at the beginning ( T@ ) , after @ sessions ( T@ ) , and at the end of the treatment ( T@ ) : Fugl-Meyer Assessment Scale ( FM ) , Modified Ashworth Scale-Shoulder ( MAS-S ) , Modified Ashworth Scale-Elbow ( MAS-E ) , Total Passive Range of Motion-Shoulder/Elbow ( pROM ) , and Motricity Index ( MI ) .


Evidence of significant improvements in MAS-S ( p = @ ) , MAS-E ( p = @ ) and pROM ( p < @ ) was found in the Experimental Group .


Significant improvement was demonstrated in both Experimental and Control Group in FM ( EG : p < @ , CG : p < @ ) and MI ( EG : p < @ , CG : p < @ ) , with an higher improvement in the Experimental Group .


Robot-assisted upper limb rehabilitation treatment can contribute to increasing motor recovery in subacute stroke patients .


Focusing on the early phase of stroke recovery has a high potential impact in clinical practice .


In advanced gastric cancer ( AGC ) , no globally accepted prognostic scoring system has been developed .


Therefore , we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial , Japan Clinical Oncology Group ( JCOG ) @ , which investigated the efficacy of systemic chemotherapy as a first-line treatment .


Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG@ using the Cox proportional hazard model .


The Royal Marsden Hospital prognostic model was also applied to the JCOG@ trial .


A total of @ ( @ % ) of the @ patients randomized in the JCOG@ trial , for whom complete data were available for multivariate analyses , was included in the present study ( @-fluorouracil arm , n = @ ; irinotecan plus cisplatin arm , n = @ ; S-@ arm , n = @ ) .


The median survival time ( MST ) for all patients was @ months .


To construct a prognostic index , we selected four risk factors by multivariate analysis : performance status @ , number of metastatic sites @ , no prior gastrectomy , and elevated alkaline phosphatase .


MSTs were @ months for patients categorized into the low-risk group , who had zero or one risk factor ( n = @ ) ; @ months for patients in the moderate-risk group , who had two or three risk factors ( n = @ ) ; and @ months for patients in the high-risk group , who had all four risk factors ( n = @ ) .


In the present study , we propose a new prognostic index for patients with AGC .


This can be used for more appropriate patient stratification in future clinical trials .


Treatment of food allergy essentially consists of food avoidance , but immunotherapy with food is emerging as a new therapeutic option .


To evaluate clinical improvement and immunological changes in patients with peach allergy following sublingual immunotherapy ( SLIT ) with a Prup@ quantified peach extract .


A randomized , double-blind , placebo-controlled clinical trial with peach SLIT was conducted .


We assessed clinical efficacy after @ months of treatment by means of double-blind , placebo-controlled oral challenges with peach and also evaluated immunological changes ( basophil activation test -LSB- BAT -RSB- and determination of sulphidoleukotriene production ) following stimulation with peach peel and pulp , rPrup@ , rMald @ , and rMal d @ stimulation .


We also measured specific IgE and IgG@ to Pru p@ .


After @ months of SLIT ( T@ ) , the active group showed a @-fold improvement in tolerance to Prup@ and a significant increase in IgE to rPrup@ and in sLT production following stimulation with peach peel and rPrup@ .


There was also a significant increase in BAT results after stimulation with rPrup@ at @ month of SLIT ( T@ ) .


Statistically significant between-group differences were only observed for BAT with peach peel and pulp at T@ and T@ and for BAT with rPru p@ at T@ .


No changes were observed in BAT with rMal d @ or rMal d @ or in IgG@ levels to nPrup@ .


SLIT with a Pru p @ quantified peach extract is clinically effective and leads to an increase in basophil activation and sulphidoleukotriene production following stimulation with rPru p@ and peach peel in the first months of treatment .


Pharmacogenetics ( PGx ) promises to optimize patient response to therapy .


However , the public 's acceptance of PGx is not well known , notably when this applies to children .


Our objective was to explore perceptions of PGx testing among individuals , who differ from each other by either parental status or educational exposure to PGx , and to explore parents ' views between PGx testing for oneself and PGx testing for their children .


An exploratory survey was conducted among parents and other adults .


Surveys P and C were completed by parents , survey NP by middle-aged nonparents , and survey MS by medical students .


Proper explanation before PGx testing appeared to be the most important issue to the respondents ( eg , P = @ @ ( -@ ) for survey NP ) .


Respondents who were more knowledgeable about PGx were also more comfortable with PGx testing ( eg , P = @ @ ( -@ ) in case of mild disease ) .


When PGx testing was for one 's child , parents valued their own understanding more than their child 's assent ( P = @ @ ( -@ ) ) .


The acceptability of PGx testing , either for oneself or for one 's child , seemed to depend on baseline PGx knowledge , but not on parenthood .


Dilatation and curettage ( D&C ) is a common day-care procedure in obstetrics and gynecology , with patients discharged after a brief hospital stay on the same day of the surgery .


Although it has a short duration , severe pain occurs during the procedure .


Therefore , this surgical procedure requires an anesthetic to provide adequate analgesia , rapid onset , and rapid recovery .


The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C .


The study comprised @ women with American Society of Anesthesiologists classification I-II who were scheduled for a D&C procedure .


Baseline anesthesia was maintained with @mg/kg propofol , and the patients were then randomly allocated to receive tramadol @mg/kg ( Group T , n = @ ) or fentanyl @g/kg ( Group F , n = @ ) .


Hemodynamic variables , sedation , pain , the Aldrete recovery score , and side-effects were recorded .


SpO levels in Group F in the @th min and at the end of the procedure were significantly lower than those in Group T ( P = @ and @ , respectively ) .


Tramadol provides similar analgesic efficacy to fentanyl .


Furthermore , tramadol may provide better respiratory stability in patients undergoing a D&C procedure .


Based on current recommendations , @ + pack-years of smoking are required for eligibility for low-dose CT ( LDCT ) lung cancer screening ; former smokers must have quit within @ years .


We investigated whether current smokers with @ to @ pack-years have similar lung cancer risks as eligible former smokers and also whether they have a different demographic profile .


The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ( PLCO ) was a randomly assigned screening trial of subjects age @ to @ years with chest radiographs ( CXR ) used for lung cancer .


Subjects completed a baseline questionnaire containing smoking history questions .


Cox proportional hazards models , adjusted for age and sex , were utilized to estimate hazard ratios ( HRs ) for various smoking history groups .


Next , we utilized the National Health Interview Survey ( NHIS ) , which inquired about smoking history and race/ethnicity , to analyze the demographic profiles of various high-risk smoking history categories .


All statistical tests were two-sided .


The PLCO cohort included @ @ former and @ @ current LDCT-eligible smokers , plus @ @ - to @-pack-year current smokers .


The hazard ratio for @ - to @-pack-year current smokers compared with eligible ( @ + pack-year ) former smokers was @ ( @ % confidence interval -LSB- CI -RSB- = @ to @ ) .


Based on the NHIS , @ million persons in the United States are currently LDCT eligible ; an additional @ million ( @ % , @ % CI = @ % to @ % ) are @ - to @-pack-year current smokers .


The percentage increase in eligibles if @ - to @-pack-year current smokers were included was substantially greater for women than men ( @ % , @ % CI = @ % to @ % ; vs @ % , @ % CI = @ % to @ % , P < @ ) and for minorities than non-Hispanic whites ( @ % , @ % CI = @ % to @ % ; vs @ % , @ % CI = @ % to @ % , P < @ ) .


The potential benefits and harms of recommending LDCT screening for @ to @-pack-year current smokers should be assessed .


Progression-free survival ( PFS ) in metastatic castration-resistant prostate cancer ( mCRPC ) trials has been inconsistently defined and poorly associated with overall survival ( OS ) .


A reproducible quantitative definition of radiographic PFS ( rPFS ) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC .


rPFS was defined as two new lesions on an @-week bone scan plus two additional lesions on a confirmatory scan , two new confirmed lesions on any scan @ weeks after random assignment , and/or progression in nodes or viscera on cross-sectional imaging , or death .


rPFS was assessed by independent review at @ % of deaths and by investigator review at @ % and @ % of deaths .


rPFS and OS association was evaluated by Spearman 's correlation .


A total of @,@ patients were randomly assigned to abiraterone plus prednisone or prednisone alone .


At first interim analysis , the hazard ratio ( HR ) by independent review was @ ( @ % CI , @ to @ ; P < @ ; abiraterone plus prednisone : median rPFS , not estimable ; prednisone : median rPFS , @ months ) .


Similar HRs were obtained by investigator review at the first two interim analyses ( HR , @ ; @ % CI , @ to @ ; P < @ and HR , @ ; @ % CI , @ to @ ; P < @ , respectively ) , validating the imaging data assay used .


Spearman 's correlation coefficient between rPFS and OS was @ .


rPFS was highly consistent and highly associated with OS , providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials .


Rehabilitation care is an important part of comprehensive care for MS patients .


Little is known about the number of physiatry residents who are interested in providing care to individuals with multiple sclerosis -LSB- MS -RSB- .


This study examines factors that influence physiatry residents ' interest in providing care to MS patients .


We randomly sampled half of all Accreditation Council for Graduate Medical Education-certified physical medicine and rehabilitation residency programs in the continental United States and Puerto Rico .


Surveys were received from @ % of programs ( Stage @ response rate ) and from @ residents ( @ % Stage @ response rate ) .


Residents expressing interest in providing MS care were more likely to be female , Asian , and to select statements emphasizing multidisciplinary care approaches and a community of dedicated professional colleagues as positive features of MS patient care .


Residents interested in teaching and with more education debt were marginally more likely to express interest in MS care .


Medical education should emphasize the need for physical medicine and rehabilitative care among individuals with MS , the ability of physiatrists to improve the functional status and quality of life for MS patients , and the team-based nature of MS care .


Lysine requirements of well-nourished children from developing regions have been found to be similar to those of children from developed regions ( @ mgkgd ) .


However , intestinal parasites have been shown to increase lysine requirements in undernourished adults , and it is not known if a similar phenomenon occurs in undernourished children from poor and unsanitary environments .


Our objective was to measure the lysine requirement of moderately undernourished school-aged Indian children by the indicator amino acid oxidation technique before and after successful treatment for intestinal parasites .


Twenty-one undernourished school-aged children ( @ y of age ) with z scores between -@ SD and -@ SD for height-for-age or weight-for-age , who tested positive for intestinal parasites , were studied before and after successful antiparasite treatment .


Children were fed any @ of @ levels of lysine intakes ( @ , @ , @ , @ , @ , @ , and @ mgkgd ) in random order .


The lysine requirement was determined by applying a @-phase linear regression crossover analysis on the fractional oxidation rate of the tracer L - -LSB- @-C -RSB- phenylalanine in response to the graded lysine intakes .


The lysine requirement of undernourished children with intestinal parasite infestations was determined to be @ mgkgd ( @ % CI : @ , @ mgkgd ) , and after successful antiparasitic treatment it was determined to be @ mgkgd ( @ % CI : @ , @ mgkgd ) .


The results were significantly different ( P < @ ) , although the @ % CIs overlapped .


The lysine requirement in undernourished children is similar to that of well-nourished children , and intestinal parasitic infestation increased the lysine requirement by @ % .


To compare the efficacy and side effects of low-dose amitriptyline ( AMT ) with proton pump inhibitor treatment in patients with globus pharyngeus .


Thirty-four patients who fulfilled the Rome III criteria for functional esophageal disorders were included in this study .


Patients were randomly assigned to receive either @ mg AMT before bedtime ( AMT group ) or @ mg Pantoprazole once daily for @ wk ( conventional group ) .


The main efficacy endpoint was assessed using the Glasgow Edinburgh Throat Scale ( GETS ) .


The secondary efficacy endpoints included the Medical Outcomes Study @-item short form health survey -LSB- social functioning ( SF ) -@ -RSB- and the Pittsburgh Sleep Quality Index .


Treatment response was defined as a > @ % reduction in GETS scores .


All patients entering this study recorded side effects at days @ , @ , @ , @ and @ using a visual analogue scale .


Thirty patients completed the study .


After @ wk of treatment , the AMT group had a greater response than the conventional group ( @ % vs @ % , P = @ ) .


At day @ , the AMT group showed significantly more improvement than the Conventional group in GETS score ( @ @ vs @ @ , P = @ ) .


After @ wk of treatment , the AMT group showed significantly greater improvement in GETS score and sleep quality than the Conventional group ( @ @ vs @ @ , @ @ vs @ @ ; P < @ for both ) .


Additionally , the AMT group was more likely than the Conventional group to experience improvement in the SF-@ , including general health , vitality , social functioning and mental health ( P = @ , @ , @ and @ ) .


Dry mouth , sleepiness , dizziness and constipation were the most common side effects .


Low-dose AMT is well tolerated and can significantly improve patient symptoms , sleep and quality of life .


Thus , low-dose AMT may be an effective treatment for globus pharyngeus .


Up to now , all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in @ .


We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-@ vector-based Ebola vaccine expressing the glycoprotein of the @ epidemic strain .


We did this randomised , double-blind , placebo-controlled , phase @ clinical trial at one site in Taizhou County , Jiangsu Province , China .


Healthy adults ( aged @-@ years ) were sequentially enrolled and randomly assigned ( @:@ ) , by computer-generated block randomisation ( block size of six ) , to receive placebo , low-dose adenovirus type-@ vector-based Ebola vaccine , or high-dose vaccine .


Randomisation was pre-stratified by dose group .


All participants , investigators , and laboratory staff were masked to treatment allocation .


The primary safety endpoint was occurrence of solicited adverse reactions within @ days of vaccination .


The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day @ after the vaccination .


Analysis was by intention to treat .


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


Between Dec @ , @ , and Jan @ , @ , @ participants were enrolled and randomly assigned to receive placebo ( n = @ ) , low-dose vaccine ( n = @ ) , or high-dose vaccine .


Participants were followed up for @ days .


Overall , @ ( @ % ) participants reported at least one solicited adverse reaction within @ days of vaccination ( n = @ in the placebo group vs n = @ in the low-dose group vs n = @ in the high-dose group ; p = @ ) .


The most common reaction was mild pain at the injection site , which was reported in eight ( @ % ) participants in the placebo group , @ ( @ % ) participants in the low-dose group , and @ ( @ % ) participants in the high-dose vaccine group ( p < @ ) .


We recorded no statistical differences in other adverse reactions and laboratory tests across groups .


Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day @ ( geometric mean titre @ -LSB- @ % CI @-@ -RSB- and @ -LSB- @-@ -RSB- , respectively ; p < @ ) and day @ ( @ -LSB- @-@ -RSB- and @ -LSB- @-@ -RSB- , respectively ; p < @ ) .


T-cell responses peaked at day @ at a median of @ spot-forming cells ( IQR @-@ ) in participants in the low-dose group and @ cells ( @-@ ) in those in the high-dose group .


@ ( @ % ) participants had mild fever ( n = @ in the placebo group , n = @ in the low-dose group , and n = @ in the high-dose group ) .


No serious adverse events were recorded .


Our findings show that the high-dose vaccine is safe and robustly immunogenic .


One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in @ days .


To evaluate the thermal antinociceptive effects and duration of action of buprenorphine hydrochloride after IM administration to American kestrels ( Falco sparverius ) .


@ healthy @-year-old American kestrels .


Buprenorphine hydrochloride ( @ , @ , and @ mg/kg ) and a control treatment ( saline -LSB- @ % NaCl -RSB- solution ) were administered IM in a randomized crossover experimental design .


Foot withdrawal response to a thermal stimulus was determined @ hour before ( baseline ) and @ , @ , and @ hours after treatment administration .


Agitation-sedation scores were determined @ to @ minutes before each thermal stimulus .


Adverse effects were monitored for @ hours after treatment administration .


Buprenorphine hydrochloride at @ , @ , and @ mg/kg , IM , increased thermal threshold for @ hours , compared with the response for the control treatment .


There were no significant differences among buprenorphine treatments .


A mild sedative effect was detected at a dose of @ mg of buprenorphine/kg .


At the doses tested , buprenorphine hydrochloride resulted in thermal antinociception in American kestrels for at least @ hours , which suggested that buprenorphine has analgesic effects in this species .


Further studies with longer evaluation periods and additional forms of noxious stimuli , formulations , dosages , and routes of administration are needed to fully evaluate the analgesic effects of buprenorphine in American kestrels .


Patellofemoral pain syndrome ( PFPS ) is a common musculoskeletal condition , particularly among women .


Patients with PFPS usually experience weakness in the gluteal muscles , as well as pain and impaired motor control during activities of daily living .


Strengthening the hip muscles is an effective way of treating this disorder .


Neuromuscular training has also been identified as a therapeutic tool , although the benefits of this intervention in patients with PFPS patients remain inconclusive .


This is a protocol of randomized controlled trial with a blind assessor .


Thirty-four women with a clinical diagnosis of PFPS participated .


These participants were allocated into two groups ( experimental and control ) .