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25227656 | conclusions | 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 . | 11 |
24831979 | background | 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 . | 0 |
24831979 | background | We assessed the predictive power of this test in the comparison of erlotinib and chemotherapy in patients with non-small-cell lung cancer . | 1 |
24831979 | methods | From Feb @ , @ , to April @ , @ , patients ( aged @ years ) with histologically or cytologically confirmed , second-line , stage IIIB or IV non-small-cell lung cancer were enrolled in @ centres in Italy . | 2 |
24831979 | methods | 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 @:@ ratio to receive erlotinib ( @ mg/day , orally ) or chemotherapy ( pemetrexed @ mg/m ( @ ) , intravenously , every @ days , or docetaxel @ mg/m ( @ ) , intravenously , every @ days ) . | 3 |
24831979 | methods | 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 . | 4 |
24831979 | methods | 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 . | 5 |
24831979 | methods | Analyses were done on the per-protocol population . | 6 |
24831979 | methods | This trial is registered with ClinicalTrials.gov , number NCT@ . | 7 |
24831979 | results | @ patients were randomly assigned to chemotherapy and @ to erlotinib , and @ ( @ % ) and @ ( @ % ) , respectively , were included in the per-protocol analysis . | 8 |
24831979 | results | @ ( @ % ) patients in the chemotherapy group and @ ( @ % ) in the erlotinib group had a proteomic test classification of good . | 9 |
24831979 | results | Median overall survival was @ months ( @ % CI @-@ ) in the chemotherapy group and @ months ( @-@ ) in the erlotinib group . | 10 |
24831979 | results | We noted a significant interaction between treatment and proteomic classification ( pinteraction = @ when adjusted for stratification factors ; pinteraction = @ when unadjusted for stratification factors ) . | 11 |
24831979 | results | Patients with a proteomic test classification of poor had worse survival on erlotinib than on chemotherapy ( hazard ratio @ -LSB- @ % CI @-@ -RSB- , p = @ ) . | 12 |
24831979 | results | There was no significant difference in overall survival between treatments for patients with a proteomic test classification of good ( adjusted HR @ -LSB- @-@ -RSB- , p = @ ) . | 13 |
24831979 | results | In the group of patients who received chemotherapy , the most common grade @ or @ toxic effect was neutropenia ( @ -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- in the erlotinib group ) , whereas skin toxicity ( one -LSB- < @ % -RSB- vs @ -LSB- @ % -RSB- ) was the most frequent in the erlotinib group . | 14 |
24831979 | conclusions | 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 . | 15 |
24831979 | conclusions | Patients classified as likely to have a poor outcome have better outcomes on chemotherapy than on erlotinib . | 16 |
25137430 | objective | 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 ) . | 0 |
25137430 | methods | Sixty-eight patients were randomly divided into two groups . | 1 |
25137430 | methods | The dexmedetomidine group ( Group D , n = @ ) received a continuous infusion of dexmedetomidine at a rate of @ g kg ( -@ ) hour ( -@ ) from the induction of anesthesia until the end of the ST position , while the control group ( Group C , n = @ ) received an equal volume of physiologic saline at the same rate under conventional general anesthesia with sevoflurane and remifentanil . | 2 |
25137430 | methods | IOP was measured at @ predefined time points for all patients . | 3 |
25137430 | results | Significant differences in IOP were detected between the two groups by a linear mixed model analysis ( p < @ ) . | 4 |
25137430 | results | The highest mean IOP was @ mm Hg in Group D and @ mm Hg in Group C ; both were measured @ minutes after the patients had been placed in the ST position . | 5 |
25137430 | results | No significant between-group differences in ocular perfusion pressure , mean blood pressure , or heart rate were observed between the two groups . | 6 |
25137430 | results | No ocular or other complications were noted . | 7 |
25137430 | conclusions | Intraoperative continuous infusion of dexmedetomidine may help alleviate IOP increase in patients undergoing RALRP in the ST position . | 8 |
25514543 | objective | Disruptive or challenging behavior problems pose a threat to children and adolescents with intellectual disabilities and their caregivers . | 0 |
25514543 | objective | Psychopharmacological treatment is mostly studied with new-generation antipsychotics and has been criticized for adverse side effects . | 1 |
25514543 | objective | This study examined the effect of the classic antipsychotic zuclopenthixol . | 2 |
25514543 | methods | A total of @ boys ( ages @-@ @ years ) with learning disabilities were included and examined for a response to zuclopenthixol during a @ week period of open label treatment . | 3 |
25514543 | methods | Doses started low and were adapted individually . | 4 |
25514543 | methods | From responders , zuclopenthixol was randomly withdrawn for @ weeks . | 5 |
25514543 | methods | Responses to withdrawal were observed by external raters using the Modified Overt Aggression Scale . | 6 |
25514543 | results | Of all patients included into the study , @ were not randomized because of insufficient therapeutic effect , adverse event , or noncompliance . | 7 |
25514543 | results | Kaplan-Meier estimations showed less aggressive behavior problems for the continuing subgroup ( n = @ ) than in the placebo group ( n = @ ) . | 8 |
25514543 | results | Individual doses stayed < @mg/day . | 9 |
25514543 | conclusions | Zuclopenthixol proved to be effective in reducing challenging behavior in boys even at low doses . | 10 |
25925990 | objective | 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 . | 0 |
25925990 | methods | Patients were randomized @:@ to ixabepilone ( @mg/m ( @ ) ) , or either paclitaxel ( @mg/m ( @ ) ) or doxorubicin ( @mg/m ( @ ) ) , every @days . | 1 |
25925990 | methods | Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel ; all other patients were randomized to ixabepilone or doxorubicin . | 2 |
25925990 | methods | An interim analysis of futility for OS was planned . | 3 |
25925990 | results | At the time of database lock , @ patients were randomized to receive ixabepilone ( n = @ ) or control ( n = @ ) ; nine patients in the control arm were not treated . | 4 |
25925990 | results | The interim analysis of futility for OS ( @ events ) favored the control chemotherapy arm ( hazard ratio = @ -LSB- @ % confidence interval : @-@ @ -RSB- , stratified log rank test P = @ ) , indicating that the study would not meet its primary objective . | 5 |
25925990 | results | The study was discontinued based on the interim OS results . | 6 |
25925990 | results | The frequency of adverse events was comparable between the treatment arms . | 7 |
25925990 | conclusions | The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm . | 8 |
25925990 | conclusions | A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis . | 9 |
25925990 | conclusions | The safety results were consistent with the known safety profiles of ixabepilone and control . | 10 |
25252480 | objective | To determine the impact of calcium and phosphorus on radiological and biochemical characteristics of osteopenia in premature infants . | 0 |
25252480 | methods | The randomised clinical trial study was conducted at Valie-e-Asr Hospital of Zanjan city , Iran , from December @ to June @ . | 1 |
25252480 | methods | It involved monitoring @ premature neonates over a period of six months . | 2 |
25252480 | methods | The babies , who were fed with breast milk and @ units of vitamin D daily , were randomly divided into two equal groups . | 3 |
25252480 | methods | One group received supplement of calcium and phosphorus . | 4 |
25252480 | methods | Serum calcium , phosphorus and alkaline phosphatase levels as well as growth parameters ( including weight , height , and head circumference ) were measured every two weeks . | 5 |
25252480 | methods | At the end of the study , wrist X-ray was done for evaluation of osteopenia . | 6 |
25252480 | methods | Data was analysed using SPSS @ . | 7 |
25252480 | results | Radiological changes , characteristic of osteopenia , were found in @ ( @ % ) cases and @ ( @ % ) controls ( p < @ ) . | 8 |
25252480 | results | The mean of weight , length and head circumference increased significantly from second to sixth week during follow-up ( p < @ ) . | 9 |
25252480 | results | Phosphorus and alkaline phosphatase activity decreased significantly from second to sixth week of follow-up ( p < @ , p < @ respectively ) . | 10 |
25252480 | results | However , repeated measurement analyses did not show significant effect of intervention in biochemical and growth parameters in the trial group . | 11 |
25252480 | conclusions | The study did n't show significant effect of calcium and phosphorus on prevention of osteopenia and improvement of growth . | 12 |
25252480 | conclusions | Further studies of longer duration and with different doses of supplement are recommended . | 13 |
24720919 | objective | The purpose of this study was to test the efficacy of a @-month course of anti-inflammatory treatment with colchicinein improving functional status of patients with stable chronic heart failure ( CHF ) . | 0 |
24720919 | background | CHF has been shown to be associated with inflammatory activation . | 1 |
24720919 | background | Inflammation has been designated as a therapeutic target in CHF . | 2 |
24720919 | methods | Patients with stable CHF were randomly assigned to colchicine ( @ mg twice daily ) or placebo for @ months . | 3 |
24720919 | methods | Theprimary endpoint was the proportion of patients achieving at least one-grade improvement in New York HeartAssociation class . | 4 |
24720919 | results | Two hundred sixty-seven patients were available for final evaluation of the primary endpoint : its rate was @ % in the control group and @ % in the colchicine group ( odds ratio : @ ; @ % confidence interval : @ to @ ; p = @ ) . | 5 |
24720919 | results | The rate of the composite of death or hospital stay for heart failure was @ % in the control group , compared with @ % in the colchicine group ( p = @ ) . | 6 |
24720919 | results | The changes in treadmill exercise time with treatment were insignificant and similar in the @ groups ( p = @ ) . | 7 |
24720919 | results | C-reactive protein and interleukin-@ were both significantly reduced in the colchicine group ( -@ mg/l and -@ pg/ml , respectively ; p < @ for both , compared with the control group ) . | 8 |
24720919 | conclusions | 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 . | 9 |
24500245 | objective | To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , randomized , double-blind clinical trial . | 0 |
24500245 | methods | One hundred eighty-nine outpatients ( @ % female , mean -LSB- SD -RSB- age = @ -LSB- @ -RSB- years ) with DSM-IV-diagnosed major depressive disorder ( MDD ) were recruited from April @ , @ , to December @ , @ , at the Massachusetts General Hospital and at Butler Hospital . | 1 |
24500245 | methods | Patients were randomized for @ weeks to SAMe @,@-@ ,@ mg/d , escitalopram @-@ mg/d , or placebo . | 2 |
24500245 | methods | Doses were escalated at @ weeks in the event of nonresponse . | 3 |
24500245 | methods | The main outcome measure was the @-item Hamilton Depression Rating Scale ( HDRS-@ ) . | 4 |
24500245 | methods | Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) . | 5 |
24500245 | results | All @ treatment arms demonstrated a significant improvement of about @-@ points in HDRS-@ scores ( P < @ for all ) , and no significant differences were observed between the treatment arms ( P > @ for all ) . | 6 |
24500245 | results | Response rates in the intent-to-treat sample were @ % for SAMe , @ % for escitalopram , and @ % for placebo . | 7 |
24500245 | results | Remission rates were @ % for SAMe , @ % for escitalopram , and @ % for placebo . | 8 |
24500245 | results | No comparisons between treatment groups attained significance ( P > @ for all ) . | 9 |
24500245 | results | Tolerability was good , with gastrointestinal side effects ( @ % for stomach discomfort and @ % for diarrhea ) as the most common in the SAMe arm . | 10 |
24500245 | results | Significant differences were observed between treatment groups for dizziness , anorgasmia , diminished mental acuity , and hot flashes ( P < @ for all ) . | 11 |
24500245 | conclusions | The results fail to support an advantage over placebo for either the investigational treatment SAMe or the standard treatment escitalopram for MDD . | 12 |
25833772 | background | Total weight loss induced by energy restriction is highly variable even under tightly controlled conditions . | 0 |
25833772 | background | Identifying weight-loss discriminants would provide a valuable weight management tool and insights into body weight regulation . | 1 |
25833772 | objective | This study characterized responsiveness to energy restriction in adults from variables including the plasma metabolome , endocrine and inflammatory markers , clinical indices , body composition , diet , and physical activity . | 2 |
25833772 | methods | Data were derived from a controlled feeding trial investigating the effect of @-@ dairy product servings in an energy-restricted diet ( @ kJ/d reduction ) over @ wk . | 3 |
25833772 | methods | Partial least squares regression was used to identify weight-loss discriminants in @ overweight and obese adults . | 4 |
25833772 | methods | Linear mixed models were developed to identify discriminant variable differences in high - vs. low-weight-loss responders . | 5 |
25833772 | results | Both pre - and postintervention variables ( n = @ ) were identified as weight-loss discriminants ( root mean squared error of prediction = @ kg ; Q ( @ ) = @ ) . | 6 |
25833772 | results | Compared with low-responders ( LR ) , high-responders ( HR ) had greater decreases in body weight ( LR : @ @ kg ; HR : @ @ kg , P < @ ) , BMI ( in kg/m ( @ ) ; LR : @ @ ; HR : @ @ , P < @ ) , and total fat ( LR : @ @ kg ; HR : @ @ kg , P < @ ) . | 7 |
25833772 | results | Significant group effects unaffected by the intervention were determined for the respiratory exchange ratio ( LR : @ @ ; HR : @ @ , P < @ ) , moderate physical activity ( LR : @ @ min ; HR : @ @ min , P = @ ) , sedentary activity ( LR : @ @ min ; HR : @ @ min , P = @ ) , and plasma stearate -LSB- LR : @,@ @,@ quantifier ion peak height ( QIPH ) ; HR : @,@ @,@ QIPH , P = @ -RSB- . | 8 |
25833772 | conclusions | Overweight and obese individuals highly responsive to energy restriction had accelerated reductions in adiposity , likely supported in part by higher lipid mobilization and combustion . | 9 |
25833772 | conclusions | A novel observation was that person-to-person differences in habitual physical activity and magnitude of weight loss were accompanied by unique blood metabolite signatures . | 10 |
25833772 | conclusions | This trial was registered at clinicaltrials.gov as NCT@ . | 11 |
24846454 | background | Endovascular repair of abdominal aortic aneurysm ( AAA ) has recently been made a class I indication in the treatment of AAA . | 0 |
24846454 | background | In comparison to the conventional open surgical treatment , endovascular AAA repair ( EVAR ) is associated with equivalent long-term morbidity and mortality rates . | 1 |
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