ml4pubmed/pubmed-classification-20k · Datasets at Hugging Face

label stringlengths 7 11	text stringlengths 2 1.45k ⌀
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 .

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 .