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CONCLUSIONS | It could promote the recovery of EB viral infection , and reduce the risk of vicious disease after EB viral infection . |
###25039547 | null |
OBJECTIVE | The primary objective was to compare the cosmetic outcomes of traumatic trunk and extremity lacerations repaired using absorbable versus nonabsorbable sutures . |
OBJECTIVE | The secondary objective was to compare complication rates between the two groups . |
METHODS | This was a randomized controlled trial comparing wounds repaired with Vicryl Rapide and Prolene sutures . |
METHODS | Pediatric and adult patients with lacerations were enrolled in the study . |
METHODS | At a 10-day follow-up , the wounds were evaluated for infection and dehiscence . |
METHODS | After 3 months , patients returned to have the wounds photographed . |
METHODS | Two plastic surgeons blinded to the method of closure rated the cosmetic outcome of each wound using a 100-mm visual analog scale ( VAS ) . |
METHODS | Using a noninferiority design , a VAS score of 13 mm or greater was considered to be a clinically significant difference . |
METHODS | We used a Student 's t-test to compare differences between mean VAS scores and odds ratios ( ORs ) to compare differences in complication rates between the two groups . |
RESULTS | Of the 115 patients enrolled , 73 completed the study including 35 in the Vicryl Rapide group and 38 in the Prolene group . |
RESULTS | The mean ( SD ) age of patients who completed the study was 22.1 ( 15.5 ) years , and 39 were male . |
RESULTS | We found no significant differences in the age , race , sex , length of wound , number of sutures , or layers of repair in the two groups . |
RESULTS | The observer 's mean VAS for the Vicryl Rapide group was 54.1 mm ( 95 % confidence interval [ CI ] = 44.5 to 67.0 mm ) and for the Prolene group was 54.5 mm ( 95 % CI = 45.7 to 66.3 mm ) . |
RESULTS | The resulting mean difference was 0.5 mm ( 95 % CI = -12.1 to 17.2 mm ; p = 0.9 ) ; thus noninferiority was established . |
RESULTS | Statistical testing showed no differences in the rates of complications between the two groups , but a higher percentage of the Vicryl Rapide wounds developed complications . |
CONCLUSIONS | The use of absorbable sutures for the repair of simple lacerations on the trunk and extremities should be considered as an alternative to nonabsorbable suture repair . |
###25139873 | null |
OBJECTIVE | Aspirin early after intravenous thrombolysis in acute ischemic stroke increases the risk of symptomatic intracranial hemorrhage ( SICH ) , without influencing functional outcome at 3 months . |
OBJECTIVE | The effect of aspirin on early neurological deterioration ( END ) was explored as a post hoc analysis of the randomized Antiplatelet Therapy in Combination With Recombinant t-PA Thrombolysis in Ischemic Stroke ( ARTIS ) trial . |
METHODS | END , defined as a 4 points National Institutes of Health Stroke Scale worsening 24 hours after intravenous thrombolysis , was categorized into SICH ( ENDSICH ) and cerebral ischemia ( ENDCI ) . |
METHODS | Multinomial logistic regression was used to assess the effect of aspirin on END . |
RESULTS | Of the 640 patients , 31 patients ( 4.8 % ) experienced END ( 14 ENDSICH , 17 ENDCI ) . |
RESULTS | Aspirin increased the risk of ENDSICH ( odds ratio , 3.73 ; 95 % confidence interval , 1.03-13 .49 ) but not of ENDCI ( odds ratio , 1.14 ; 95 % confidence interval , 0.44-3 .00 ) . |
RESULTS | After adjustment for other explanatory variables , the association between aspirin and ENDSICH remained significant . |
CONCLUSIONS | In this trial , there is no evidence of an early antithrombotic effect from the addition of aspirin to intravenous thrombolysis in acute ischemic stroke . |
###24917273 | null |
OBJECTIVE | To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis , posterior uveitis , or panuveitis . |
METHODS | Multicenter , block-randomized , observer-masked clinical trial . |
METHODS | Eighty patients with noninfectious intermediate , posterior , or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore , India . |
METHODS | Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months . |
METHODS | Oral prednisone and topical corticosteroids were tapered . |
METHODS | Masked examiners assessed the primary outcome of treatment success , defined by achieving the following at 5 and 6 months : ( 1 ) 0.5 + anterior chamber cells , 0.5 + vitreous cells , 0.5 + vitreous haze and no active retinal/choroidal lesions in both eyes , ( 2 ) 10 mg of prednisone and 2 drops of prednisolone acetate 1 % a day , and ( 3 ) no declaration of treatment failure because of intolerability or safety . |
METHODS | Additional outcomes included time to sustained corticosteroid-sparing control of inflammation , change in best spectacle-corrected visual acuity , resolution of macular edema , adverse events , subgroup analysis by anatomic location , and medication adherence . |
RESULTS | Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil . |
RESULTS | A total of 67 patients ( 35 methotrexate , 32 mycophenolate mofetil ) contributed to the primary outcome . |
RESULTS | Sixty-nine percent of patients achieved treatment success with methotrexate and 47 % with mycophenolate mofetil ( P = 0.09 ) . |
RESULTS | Treatment failure from adverse events or tolerability was not different by treatment arm ( P = 0.99 ) . |
RESULTS | There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation ( P = 0.44 ) , change in best spectacle-corrected visual acuity ( P = 0.68 ) , or resolution of macular edema ( P = 0.31 ) . |
CONCLUSIONS | There was no statistically significant difference in corticosteroid-sparing control of inflammation between patients receiving methotrexate or mycophenolate mofetil . |
CONCLUSIONS | However , there was a 22 % difference in treatment success favoring methotrexate . |
###24925006 | null |
BACKGROUND | The prevalence of methicillin-resistant Staphylococcus aureus ( MRSA ) respiratory infection in cystic fibrosis ( CF ) has increased dramatically over the last decade , and is now affecting approximately 25 % of patients . |
BACKGROUND | Epidemiologic evidence suggests that persistent infection with MRSA results in an increased rate of decline in FEV1 and shortened survival . |
BACKGROUND | Currently , there are no conclusive studies demonstrating an effective and safe treatment protocol for persistent MRSA respiratory infection in CF. |
METHODS | The primary objective of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation in combination with oral antibiotics in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection . |
METHODS | This is a two-center , randomized , double-blind , comparator-controlled , parallel-group study with 1:1 assignment to either vancomycin for inhalation ( 250mg twice a day ) or taste-matched placebo for 28days in individuals with cystic fibrosis . |
METHODS | In addition , both groups will receive oral rifampin , a second oral antibiotic - trimethoprim/sulfamethoxazole ( TMP/SMX ) or doxycycline , protocol determined - mupirocin intranasal cream , and chlorhexidine body washes . |
METHODS | Forty patients with persistent respiratory tract MRSA infection will be enrolled : 20 will be randomized to vancomycin for inhalation and 20 to a taste-matched placebo . |
METHODS | The primary outcome will be the presence of MRSA in sputum respiratory tract cultures 1month after the conclusion of treatment . |
METHODS | Secondary outcomes include the efficacy of the intervention on : FEV1 % predicted , patient reported outcomes , pulmonary exacerbations , and MRSA colony-forming units found in respiratory tract sample culture . |
CONCLUSIONS | Results of this study will provide guidance to clinicians regarding the safety and effectiveness of a targeted eradication strategy for persistent MRSA infection in CF. |
BACKGROUND | This trial is registered at ClinicalTrials.gov ( NCT01594827 , received 05/07/2012 ) and is funded by the Cystic Fibrosis Foundation ( Grants : PMEP10K1 and PMEP11K1 ) . |
###24559194 | null |
BACKGROUND | There is a strong association between weight gain and metabolic events in patients with schizophrenia receiving many of the second-generation antipsychotic agents . |
BACKGROUND | We explored the relationship between body mass index ( BMI ) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate ( PP ) in a long-term trial . |
METHODS | We conducted a post hoc analysis of data from a PP study that included a 33-week open-label transition ( TR ) and maintenance phase ; a variable duration , randomized , double-blind ( DB ) , placebo-controlled phase and a 52-week open-label extension ( OLE ) phase . |
METHODS | Overall , 644 patients received PP continuously from study entry through discontinuation or study completion and were grouped by baseline BMI ( kg/m2 ) : underweight ( BMI < 19 ; n = 29 , 4.5 % ) , normal-weight ( BMI 19 - < 25 ; n = 229 , 35.6 % ) , overweight ( BMI 25 - < 30 ; n = 232 , 36.0 % ) and obese ( BMI 30 ; n = 154 , 23.9 % ) . |
METHODS | Metabolic treatment-emergent adverse events ( TEAEs ) and changes in related laboratory results from TR baseline were analyzed . |
RESULTS | PP exposure was similar across BMI groups ; overall mean ( SD ) dose/month was 70.3 ( 17.17 ) mg eq . |
RESULTS | [ 109.6 ( 26.78 ) mg ] ; median duration of exposure was 204 days ( 6 to 1009 days ) . |
RESULTS | Occurrences of metabolic TEAEs overall by group were 0 % ( underweight ) , 14.9 % ( normal-weight ) , 14.7 % ( overweight ) , and 24.0 % ( obese ) . |
RESULTS | The most common ( 2 % ) metabolic TEAE were weight gain and elevated blood levels of glucose , lipids , and insulin . |
RESULTS | Mean BMI and weight increased in normal-weight and overweight groups at DB endpoint , and in underweight , normal-weight and overweight groups at OLE endpoint ( p 0.05 ) . |
RESULTS | No consistent trend for increased metabolic-related laboratory values by baseline BMI group was observed . |
RESULTS | Homeostatic model assessments for insulin resistance indicated preexisting insulin resistance at baseline , with minimal changes at OLE endpoint across baseline BMI groups . |
CONCLUSIONS | Occurrences of metabolic-related TEAEs trended with greater BMI status in patients with schizophrenia treated with PP ; consistent trends in metabolic-related laboratory values were not observed . |
BACKGROUND | This study is registered at ClinicalTrials.gov ( NCT 00518323 ) . |
###25203483 | null |
BACKGROUND | Fecal immunochemical tests ( FITs ) are recommended to screen average-risk adults for colorectal cancer ( CRC ) . |
BACKGROUND | Little research has examined whether a two-sample FIT affects participant uptake , compared with a one-sample FIT . |
BACKGROUND | Examining participant uptake is important , as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC . |
OBJECTIVE | 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 . |
METHODS | 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 . |
METHODS | 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 . |
METHODS | 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 . |
RESULTS | 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 . |
RESULTS | Participant uptake did not vary by age , sex , or receipt of prior CRC screening . |
CONCLUSIONS | This unique , rigorous randomized controlled trial found that the 2-FIT regimen decreases completion of FIT . |
CONCLUSIONS | Further research is needed to understand whether decreases in participant uptake are offset by increased gains in test sensitivity . |
###25227656 | null |
OBJECTIVE | 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 ) . |
METHODS | Patients received pazopanib 800 mg/day . |
METHODS | The primary endpoint was the safety and tolerability of pazopanib treatment . |
METHODS | Secondary endpoints included response rate per Response Evaluation Criteria in Solid Tumors , progression-free survival ( PFS ) , and overall survival ( OS ) . |
RESULTS | Seventy-nine placebo-treated patients from VEG105192/NCT00334282 who experienced disease progression and one pazopanib-treated patient ( an exemption ) were enrolled . |
RESULTS | Forty-one patients ( 51 % ) were treatment-naive ; 39 ( 49 % ) were cytokine-pretreated . |
RESULTS | Median exposure to pazopanib was 9.7 months . |
RESULTS | All patients had discontinued pazopanib at the time of analysis . |
RESULTS | The most common reason for discontinuation was disease progression ( 61 % ) . |
RESULTS | The most common adverse events were hypertension ( 45 % ) , diarrhea ( 45 % ) , hair color changes ( 44 % ) , anorexia ( 30 % ) , and nausea ( 25 % ) . |
RESULTS | 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 ) . |
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 . |
###24831979 | null |
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 . |
BACKGROUND | We assessed the predictive power of this test in the comparison of erlotinib and chemotherapy in patients with non-small-cell lung cancer . |
METHODS | 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 . |
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 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 ) . |
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 . |