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Examining participant uptake is important , as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC .
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This study had two objectives : ( i ) to evaluate FIT completion in a population that received either a one-sample FIT kit ( 1-FIT ) or a two-sample FIT kit ( 2-FIT ) and ( ii ) to understand whether uptake varies by age , sex , or receipt of prior CRC screening .
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We conducted a randomized controlled trial in which 3081 participants who were aged between 50 and 75 years and were at an average risk for CRC , and who had requested FITs , randomly received 1-FIT ( n = 1540 ) or 2-FIT ( n = 1541 ) kits .
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FIT completion was defined as the completion and return of a one-sample test by the patients in the 1-FIT group or of both sample tests by those in the 2-FIT group .
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Cox proportional hazard regression models were used to determine the independent effect of group type ( 2-FIT vs. 1-FIT ) on the completion of the FIT , adjusting for age , sex , and receipt of prior CRC screening .
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The 2-FIT group had lower test completion rates ( hazard ratio = 0.87 ; 95 % confidence interval = 0.78-0 .97 ; P = 0.01 ) after adjusting for age , sex , and receipt of prior CRC screening .
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Participant uptake did not vary by age , sex , or receipt of prior CRC screening .
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This unique , rigorous randomized controlled trial found that the 2-FIT regimen decreases completion of FIT .
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Further research is needed to understand whether decreases in participant uptake are offset by increased gains in test sensitivity .
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Evaluation of the safety and efficacy of pazopanib , a multikinase angiogenesis inhibitor , in a single-arm , open-label , extension study ( VEG107769/NCT00387764 ) for placebo-treated patients with advanced renal cell carcinoma ( RCC ) from a randomized , double-blind , placebo-controlled phase III study ( VEG105192/NCT00334282 ) .
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Patients received pazopanib 800 mg/day .
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The primary endpoint was the safety and tolerability of pazopanib treatment .
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Secondary endpoints included response rate per Response Evaluation Criteria in Solid Tumors , progression-free survival ( PFS ) , and overall survival ( OS ) .
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Seventy-nine placebo-treated patients from VEG105192/NCT00334282 who experienced disease progression and one pazopanib-treated patient ( an exemption ) were enrolled .
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Forty-one patients ( 51 % ) were treatment-naive ; 39 ( 49 % ) were cytokine-pretreated .
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Median exposure to pazopanib was 9.7 months .
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All patients had discontinued pazopanib at the time of analysis .
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The most common reason for discontinuation was disease progression ( 61 % ) .
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The most common adverse events were hypertension ( 45 % ) , diarrhea ( 45 % ) , hair color changes ( 44 % ) , anorexia ( 30 % ) , and nausea ( 25 % ) .
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The response rate was 37.5 % [ 95 % confidence interval ( CI ) : 26.9-48 .1 ] ; median PFS was 9.2 months ( 95 % CI : 7.3-12 .0 ) ; median OS was 23.5 months ( 95 % CI : 16.3-28 .0 ) .
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Efficacy and safety profiles for pazopanib in this extension study of patients with RCC previously treated with placebo were very similar to those observed for pazopanib-treated patients in the pivotal phase III study .
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An established multivariate serum protein test can be used to classify patients according to whether they are likely to have a good or poor outcome after treatment with EGFR tyrosine-kinase inhibitors .
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We assessed the predictive power of this test in the comparison of erlotinib and chemotherapy in patients with non-small-cell lung cancer .
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From Feb 26 , 2008 , to April 11 , 2012 , patients ( aged 18 years ) with histologically or cytologically confirmed , second-line , stage IIIB or IV non-small-cell lung cancer were enrolled in 14 centres in Italy .
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Patients were stratified according to a minimisation algorithm by Eastern Cooperative Oncology Group performance status , smoking history , centre , and masked pretreatment serum protein test classification , and randomly assigned centrally in a 1:1 ratio to receive erlotinib ( 150 mg/day , orally ) or chemotherapy ( pemetrexed 500 mg/m ( 2 ) , intravenously , every 21 days , or docetaxel 75 mg/m ( 2 ) , intravenously , every 21 days ) .
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The proteomic test classification was masked for patients and investigators who gave treatments , and treatment allocation was masked for investigators who generated the proteomic classification .
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The primary endpoint was overall survival and the primary hypothesis was the existence of a significant interaction between the serum protein test classification and treatment .
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Analyses were done on the per-protocol population .
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This trial is registered with ClinicalTrials.gov , number NCT00989690 .
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142 patients were randomly assigned to chemotherapy and 143 to erlotinib , and 129 ( 91 % ) and 134 ( 94 % ) , respectively , were included in the per-protocol analysis .
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88 ( 68 % ) patients in the chemotherapy group and 96 ( 72 % ) in the erlotinib group had a proteomic test classification of good .
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Median overall survival was 90 months ( 95 % CI 68-109 ) in the chemotherapy group and 77 months ( 59-104 ) in the erlotinib group .
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We noted a significant interaction between treatment and proteomic classification ( pinteraction = 0017 when adjusted for stratification factors ; pinteraction = 0031 when unadjusted for stratification factors ) .
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Patients with a proteomic test classification of poor had worse survival on erlotinib than on chemotherapy ( hazard ratio 172 [ 95 % CI 108-274 ] , p = 0022 ) .
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There was no significant difference in overall survival between treatments for patients with a proteomic test classification of good ( adjusted HR 106 [ 077-146 ] , p = 0714 ) .
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In the group of patients who received chemotherapy , the most common grade 3 or 4 toxic effect was neutropenia ( 19 [ 15 % ] vs one [ < 1 % ] in the erlotinib group ) , whereas skin toxicity ( one [ < 1 % ] vs 22 [ 16 % ] ) was the most frequent in the erlotinib group .
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Our findings indicate that serum protein test status is predictive of differential benefit in overall survival for erlotinib versus chemotherapy in the second-line setting .
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Patients classified as likely to have a poor outcome have better outcomes on chemotherapy than on erlotinib .
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Italian Ministry of Health , Italian Association of Cancer Research , and Biodesix .
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This study was to evaluate the effect of intraoperative continuous infusion of dexmedetomidine on intraocular pressure ( IOP ) in patients undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) in the steep Trendelenburg ( ST ) .
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Sixty-eight patients were randomly divided into two groups .
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The dexmedetomidine group ( Group D , n = 34 ) received a continuous infusion of dexmedetomidine at a rate of 0.4 g kg ( -1 ) hour ( -1 ) from the induction of anesthesia until the end of the ST position , while the control group ( Group C , n = 34 ) received an equal volume of physiologic saline at the same rate under conventional general anesthesia with sevoflurane and remifentanil .
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IOP was measured at 11 predefined time points for all patients .
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Significant differences in IOP were detected between the two groups by a linear mixed model analysis ( p < 0.001 ) .
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The highest mean IOP was 19.95.0 mm Hg in Group D and 25.75.0 mm Hg in Group C ; both were measured 60 minutes after the patients had been placed in the ST position .
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No significant between-group differences in ocular perfusion pressure , mean blood pressure , or heart rate were observed between the two groups .
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No ocular or other complications were noted .
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Intraoperative continuous infusion of dexmedetomidine may help alleviate IOP increase in patients undergoing RALRP in the ST position .
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Disruptive or challenging behavior problems pose a threat to children and adolescents with intellectual disabilities and their caregivers .
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Psychopharmacological treatment is mostly studied with new-generation antipsychotics and has been criticized for adverse side effects .
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This study examined the effect of the classic antipsychotic zuclopenthixol .
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A total of 39 boys ( ages 8.0-17 .11 years ) with learning disabilities were included and examined for a response to zuclopenthixol during a 6 week period of open label treatment .
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Doses started low and were adapted individually .
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From responders , zuclopenthixol was randomly withdrawn for 12 weeks .
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Responses to withdrawal were observed by external raters using the Modified Overt Aggression Scale .
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Of all patients included into the study , 15 were not randomized because of insufficient therapeutic effect , adverse event , or noncompliance .
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Kaplan-Meier estimations showed less aggressive behavior problems for the continuing subgroup ( n = 9 ) than in the placebo group ( n = 15 ) .
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Individual doses stayed < 10mg/day .
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Zuclopenthixol proved to be effective in reducing challenging behavior in boys even at low doses .
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The purpose of this multicenter , open label , randomized phase III study was to determine whether ixabepilone resulted in improved overall survival ( OS ) compared with commonly used single-agent chemotherapy ( doxorubicin or paclitaxel ) in women with locally advanced , recurrent , or metastatic endometrial cancer with at least one failed prior platinum-based chemotherapeutic regimen .
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Patients were randomized 1:1 to ixabepilone ( 40mg/m ( 2 ) ) , or either paclitaxel ( 175mg/m ( 2 ) ) or doxorubicin ( 60mg/m ( 2 ) ) , every 21days .
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Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel ; all other patients were randomized to ixabepilone or doxorubicin .
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An interim analysis of futility for OS was planned .
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At the time of database lock , 496 patients were randomized to receive ixabepilone ( n = 248 ) or control ( n = 248 ) ; nine patients in the control arm were not treated .
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The interim analysis of futility for OS ( 219 events ) favored the control chemotherapy arm ( hazard ratio = 1.3 [ 95 % confidence interval : 1.0-1 .7 ] , stratified log rank test P = 0.0397 ) , indicating that the study would not meet its primary objective .
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The study was discontinued based on the interim OS results .
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The frequency of adverse events was comparable between the treatment arms .
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The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm .
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A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis .
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The safety results were consistent with the known safety profiles of ixabepilone and control .
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To determine the impact of calcium and phosphorus on radiological and biochemical characteristics of osteopenia in premature infants .
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The randomised clinical trial study was conducted at Valie-e-Asr Hospital of Zanjan city , Iran , from December 2010 to June 2011 .
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It involved monitoring 40 premature neonates over a period of six months .
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The babies , who were fed with breast milk and 400 units of vitamin D daily , were randomly divided into two equal groups .
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One group received supplement of calcium and phosphorus .
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Serum calcium , phosphorus and alkaline phosphatase levels as well as growth parameters ( including weight , height , and head circumference ) were measured every two weeks .
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At the end of the study , wrist X-ray was done for evaluation of osteopenia .
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Data was analysed using SPSS 16 .
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Radiological changes , characteristic of osteopenia , were found in 8 ( 40 % ) cases and 13 ( 65 % ) controls ( p < 0.113 ) .
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The mean of weight , length and head circumference increased significantly from second to sixth week during follow-up ( p < 0.0001 ) .
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Phosphorus and alkaline phosphatase activity decreased significantly from second to sixth week of follow-up ( p < 0.02 , p < 0.01 respectively ) .
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However , repeated measurement analyses did not show significant effect of intervention in biochemical and growth parameters in the trial group .
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The study did n't show significant effect of calcium and phosphorus on prevention of osteopenia and improvement of growth .
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Further studies of longer duration and with different doses of supplement are recommended .
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The purpose of this study was to test the efficacy of a 6-month course of anti-inflammatory treatment with colchicinein improving functional status of patients with stable chronic heart failure ( CHF ) .
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CHF has been shown to be associated with inflammatory activation .
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Inflammation has been designated as a therapeutic target in CHF .
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Patients with stable CHF were randomly assigned to colchicine ( 0.5 mg twice daily ) or placebo for 6 months .
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Theprimary endpoint was the proportion of patients achieving at least one-grade improvement in New York HeartAssociation class .
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Two hundred sixty-seven patients were available for final evaluation of the primary endpoint : its rate was 11 % in the control group and 14 % in the colchicine group ( odds ratio : 1.40 ; 95 % confidence interval : 0.67 to 2.93 ; p = 0.365 ) .
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The rate of the composite of death or hospital stay for heart failure was 9.4 % in the control group , compared with 10.1 % in the colchicine group ( p = 0.839 ) .
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The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups ( p = 0.938 ) .
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C-reactive protein and interleukin-6 were both significantly reduced in the colchicine group ( -5.1 mg/l and -4.8 pg/ml , respectively ; p < 0.001 for both , compared with the control group ) .
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According to this prospective , randomized study , anti-inflammatory treatment with colchicine in patients with stable CHF , although effective in reducing inflammation biomarker levels , did not affect in any significant way patient functional status ( in terms of New York Heart Association class and objective treadmill exercise tolerance ) or the likelihood of death or hospital stay for heart failure .
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To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , randomized , double-blind clinical trial .
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One hundred eighty-nine outpatients ( 49.7 % female , mean [ SD ] age = 45 [ 15 ] years ) with DSM-IV-diagnosed major depressive disorder ( MDD ) were recruited from April 13 , 2005 , to December 22 , 2009 , at the Massachusetts General Hospital and at Butler Hospital .
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Patients were randomized for 12 weeks to SAMe 1,600-3 ,200 mg/d , escitalopram 10-20 mg/d , or placebo .
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Doses were escalated at 6 weeks in the event of nonresponse .
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The main outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) .
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Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) .
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