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

label stringlengths 7 11	text stringlengths 2 1.45k ⌀
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 .
METHODS	Analyses were done on the per-protocol population .
METHODS	This trial is registered with ClinicalTrials.gov , number NCT00989690 .
RESULTS	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 .
RESULTS	88 ( 68 % ) patients in the chemotherapy group and 96 ( 72 % ) in the erlotinib group had a proteomic test classification of good .
RESULTS	Median overall survival was 90 months ( 95 % CI 68-109 ) in the chemotherapy group and 77 months ( 59-104 ) in the erlotinib group .
RESULTS	We noted a significant interaction between treatment and proteomic classification ( pinteraction = 0017 when adjusted for stratification factors ; pinteraction = 0031 when unadjusted for stratification factors ) .
RESULTS	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 ) .
RESULTS	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 ) .
RESULTS	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 .
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 .
CONCLUSIONS	Patients classified as likely to have a poor outcome have better outcomes on chemotherapy than on erlotinib .
BACKGROUND	Italian Ministry of Health , Italian Association of Cancer Research , and Biodesix .
###25137430	null
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 ) .
METHODS	Sixty-eight patients were randomly divided into two groups .
METHODS	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 .
METHODS	IOP was measured at 11 predefined time points for all patients .
RESULTS	Significant differences in IOP were detected between the two groups by a linear mixed model analysis ( p < 0.001 ) .
RESULTS	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 .
RESULTS	No significant between-group differences in ocular perfusion pressure , mean blood pressure , or heart rate were observed between the two groups .
RESULTS	No ocular or other complications were noted .
CONCLUSIONS	Intraoperative continuous infusion of dexmedetomidine may help alleviate IOP increase in patients undergoing RALRP in the ST position .
###25514543	null
OBJECTIVE	Disruptive or challenging behavior problems pose a threat to children and adolescents with intellectual disabilities and their caregivers .
OBJECTIVE	Psychopharmacological treatment is mostly studied with new-generation antipsychotics and has been criticized for adverse side effects .
OBJECTIVE	This study examined the effect of the classic antipsychotic zuclopenthixol .
METHODS	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 .
METHODS	Doses started low and were adapted individually .
METHODS	From responders , zuclopenthixol was randomly withdrawn for 12 weeks .
METHODS	Responses to withdrawal were observed by external raters using the Modified Overt Aggression Scale .
RESULTS	Of all patients included into the study , 15 were not randomized because of insufficient therapeutic effect , adverse event , or noncompliance .
RESULTS	Kaplan-Meier estimations showed less aggressive behavior problems for the continuing subgroup ( n = 9 ) than in the placebo group ( n = 15 ) .
RESULTS	Individual doses stayed < 10mg/day .
CONCLUSIONS	Zuclopenthixol proved to be effective in reducing challenging behavior in boys even at low doses .
###25925990	null
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 .
METHODS	Patients were randomized 1:1 to ixabepilone ( 40mg/m ( 2 ) ) , or either paclitaxel ( 175mg/m ( 2 ) ) or doxorubicin ( 60mg/m ( 2 ) ) , every 21days .
METHODS	Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel ; all other patients were randomized to ixabepilone or doxorubicin .
METHODS	An interim analysis of futility for OS was planned .
RESULTS	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 .
RESULTS	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 .
RESULTS	The study was discontinued based on the interim OS results .
RESULTS	The frequency of adverse events was comparable between the treatment arms .
CONCLUSIONS	The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm .
CONCLUSIONS	A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis .
CONCLUSIONS	The safety results were consistent with the known safety profiles of ixabepilone and control .
###25252480	null
OBJECTIVE	To determine the impact of calcium and phosphorus on radiological and biochemical characteristics of osteopenia in premature infants .
METHODS	The randomised clinical trial study was conducted at Valie-e-Asr Hospital of Zanjan city , Iran , from December 2010 to June 2011 .
METHODS	It involved monitoring 40 premature neonates over a period of six months .
METHODS	The babies , who were fed with breast milk and 400 units of vitamin D daily , were randomly divided into two equal groups .
METHODS	One group received supplement of calcium and phosphorus .
METHODS	Serum calcium , phosphorus and alkaline phosphatase levels as well as growth parameters ( including weight , height , and head circumference ) were measured every two weeks .
METHODS	At the end of the study , wrist X-ray was done for evaluation of osteopenia .
METHODS	Data was analysed using SPSS 16 .
RESULTS	Radiological changes , characteristic of osteopenia , were found in 8 ( 40 % ) cases and 13 ( 65 % ) controls ( p < 0.113 ) .
RESULTS	The mean of weight , length and head circumference increased significantly from second to sixth week during follow-up ( p < 0.0001 ) .
RESULTS	Phosphorus and alkaline phosphatase activity decreased significantly from second to sixth week of follow-up ( p < 0.02 , p < 0.01 respectively ) .
RESULTS	However , repeated measurement analyses did not show significant effect of intervention in biochemical and growth parameters in the trial group .
CONCLUSIONS	The study did n't show significant effect of calcium and phosphorus on prevention of osteopenia and improvement of growth .
CONCLUSIONS	Further studies of longer duration and with different doses of supplement are recommended .
###24720919	null
OBJECTIVE	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 ) .
BACKGROUND	CHF has been shown to be associated with inflammatory activation .
BACKGROUND	Inflammation has been designated as a therapeutic target in CHF .
METHODS	Patients with stable CHF were randomly assigned to colchicine ( 0.5 mg twice daily ) or placebo for 6 months .
METHODS	Theprimary endpoint was the proportion of patients achieving at least one-grade improvement in New York HeartAssociation class .
RESULTS	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 ) .
RESULTS	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 ) .
RESULTS	The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups ( p = 0.938 ) .
RESULTS	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 ) .
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 .
###24500245	null
OBJECTIVE	To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , randomized , double-blind clinical trial .
METHODS	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 .
METHODS	Patients were randomized for 12 weeks to SAMe 1,600-3 ,200 mg/d , escitalopram 10-20 mg/d , or placebo .
METHODS	Doses were escalated at 6 weeks in the event of nonresponse .
METHODS	The main outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) .
METHODS	Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) .
RESULTS	All 3 treatment arms demonstrated a significant improvement of about 5-6 points in HDRS-17 scores ( P < .001 for all ) , and no significant differences were observed between the treatment arms ( P > .05 for all ) .
RESULTS	Response rates in the intent-to-treat sample were 36 % for SAMe , 34 % for escitalopram , and 30 % for placebo .
RESULTS	Remission rates were 28 % for SAMe , 28 % for escitalopram , and 17 % for placebo .
RESULTS	No comparisons between treatment groups attained significance ( P > .05 for all ) .
RESULTS	Tolerability was good , with gastrointestinal side effects ( 19 % for stomach discomfort and 20 % for diarrhea ) as the most common in the SAMe arm .
RESULTS	Significant differences were observed between treatment groups for dizziness , anorgasmia , diminished mental acuity , and hot flashes ( P < .05 for all ) .
CONCLUSIONS	The results fail to support an advantage over placebo for either the investigational treatment SAMe or the standard treatment escitalopram for MDD .
BACKGROUND	ClinicalTrials.gov identifier : NCT00101452 .
###25833772	null
BACKGROUND	Total weight loss induced by energy restriction is highly variable even under tightly controlled conditions .
BACKGROUND	Identifying weight-loss discriminants would provide a valuable weight management tool and insights into body weight regulation .
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 .
METHODS	Data were derived from a controlled feeding trial investigating the effect of 3-4 dairy product servings in an energy-restricted diet ( 2092 kJ/d reduction ) over 12 wk .
METHODS	Partial least squares regression was used to identify weight-loss discriminants in 67 overweight and obese adults .
METHODS	Linear mixed models were developed to identify discriminant variable differences in high - vs. low-weight-loss responders .
RESULTS	Both pre - and postintervention variables ( n = 127 ) were identified as weight-loss discriminants ( root mean squared error of prediction = 1.85 kg ; Q ( 2 ) = 0.43 ) .
RESULTS	Compared with low-responders ( LR ) , high-responders ( HR ) had greater decreases in body weight ( LR : 2.7 1.6 kg ; HR : 9.4 1.8 kg , P < 0.01 ) , BMI ( in kg/m ( 2 ) ; LR : 1.0 0.6 ; HR : 3.3 0.5 , P < 0.01 ) , and total fat ( LR : 2.2 1.1 kg ; HR : 8.0 2.1 kg , P < 0.01 ) .
RESULTS	Significant group effects unaffected by the intervention were determined for the respiratory exchange ratio ( LR : 0.86 0.05 ; HR : 0.82 0.03 , P < 0.01 ) , moderate physical activity ( LR : 127 52 min ; HR : 167 68 min , P = 0.02 ) , sedentary activity ( LR : 1090 99 min ; HR : 1017 110 min , P = 0.02 ) , and plasma stearate [ LR : 102,000 21,000 quantifier ion peak height ( QIPH ) ; HR : 116,000 24,000 QIPH , P = 0.01 ] .
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 .
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 .

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 .

METHODS

Analyses were done on the per-protocol population .

METHODS

This trial is registered with ClinicalTrials.gov , number NCT00989690 .

RESULTS

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 .

RESULTS

88 ( 68 % ) patients in the chemotherapy group and 96 ( 72 % ) in the erlotinib group had a proteomic test classification of good .

RESULTS

Median overall survival was 90 months ( 95 % CI 68-109 ) in the chemotherapy group and 77 months ( 59-104 ) in the erlotinib group .

RESULTS

We noted a significant interaction between treatment and proteomic classification ( pinteraction = 0017 when adjusted for stratification factors ; pinteraction = 0031 when unadjusted for stratification factors ) .

RESULTS

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 ) .

RESULTS

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 ) .

RESULTS

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 .

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 .

CONCLUSIONS

Patients classified as likely to have a poor outcome have better outcomes on chemotherapy than on erlotinib .

BACKGROUND

Italian Ministry of Health , Italian Association of Cancer Research , and Biodesix .

###25137430

null

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 ) .

METHODS

Sixty-eight patients were randomly divided into two groups .

METHODS

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 .

METHODS

IOP was measured at 11 predefined time points for all patients .

RESULTS

Significant differences in IOP were detected between the two groups by a linear mixed model analysis ( p < 0.001 ) .

RESULTS

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 .

RESULTS

No significant between-group differences in ocular perfusion pressure , mean blood pressure , or heart rate were observed between the two groups .

RESULTS

No ocular or other complications were noted .

CONCLUSIONS

Intraoperative continuous infusion of dexmedetomidine may help alleviate IOP increase in patients undergoing RALRP in the ST position .

###25514543

null

OBJECTIVE

Disruptive or challenging behavior problems pose a threat to children and adolescents with intellectual disabilities and their caregivers .

OBJECTIVE

Psychopharmacological treatment is mostly studied with new-generation antipsychotics and has been criticized for adverse side effects .

OBJECTIVE

This study examined the effect of the classic antipsychotic zuclopenthixol .

METHODS

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 .

METHODS

Doses started low and were adapted individually .

METHODS

From responders , zuclopenthixol was randomly withdrawn for 12 weeks .

METHODS

Responses to withdrawal were observed by external raters using the Modified Overt Aggression Scale .

RESULTS

Of all patients included into the study , 15 were not randomized because of insufficient therapeutic effect , adverse event , or noncompliance .

RESULTS

Kaplan-Meier estimations showed less aggressive behavior problems for the continuing subgroup ( n = 9 ) than in the placebo group ( n = 15 ) .

RESULTS

Individual doses stayed < 10mg/day .

CONCLUSIONS

Zuclopenthixol proved to be effective in reducing challenging behavior in boys even at low doses .

###25925990

null

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 .

METHODS

Patients were randomized 1:1 to ixabepilone ( 40mg/m ( 2 ) ) , or either paclitaxel ( 175mg/m ( 2 ) ) or doxorubicin ( 60mg/m ( 2 ) ) , every 21days .

METHODS

Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel ; all other patients were randomized to ixabepilone or doxorubicin .

METHODS

An interim analysis of futility for OS was planned .

RESULTS

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 .

RESULTS

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 .

RESULTS

The study was discontinued based on the interim OS results .

RESULTS

The frequency of adverse events was comparable between the treatment arms .

CONCLUSIONS

The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm .

CONCLUSIONS

A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis .

CONCLUSIONS

The safety results were consistent with the known safety profiles of ixabepilone and control .

###25252480

null

OBJECTIVE

To determine the impact of calcium and phosphorus on radiological and biochemical characteristics of osteopenia in premature infants .

METHODS

The randomised clinical trial study was conducted at Valie-e-Asr Hospital of Zanjan city , Iran , from December 2010 to June 2011 .

METHODS

It involved monitoring 40 premature neonates over a period of six months .

METHODS

The babies , who were fed with breast milk and 400 units of vitamin D daily , were randomly divided into two equal groups .

METHODS

One group received supplement of calcium and phosphorus .

METHODS

Serum calcium , phosphorus and alkaline phosphatase levels as well as growth parameters ( including weight , height , and head circumference ) were measured every two weeks .

METHODS

At the end of the study , wrist X-ray was done for evaluation of osteopenia .

METHODS

Data was analysed using SPSS 16 .

RESULTS

Radiological changes , characteristic of osteopenia , were found in 8 ( 40 % ) cases and 13 ( 65 % ) controls ( p < 0.113 ) .

RESULTS

The mean of weight , length and head circumference increased significantly from second to sixth week during follow-up ( p < 0.0001 ) .

RESULTS

Phosphorus and alkaline phosphatase activity decreased significantly from second to sixth week of follow-up ( p < 0.02 , p < 0.01 respectively ) .

RESULTS

However , repeated measurement analyses did not show significant effect of intervention in biochemical and growth parameters in the trial group .

CONCLUSIONS

The study did n't show significant effect of calcium and phosphorus on prevention of osteopenia and improvement of growth .

CONCLUSIONS

Further studies of longer duration and with different doses of supplement are recommended .

###24720919

null

OBJECTIVE

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 ) .

BACKGROUND

CHF has been shown to be associated with inflammatory activation .

BACKGROUND

Inflammation has been designated as a therapeutic target in CHF .

METHODS

Patients with stable CHF were randomly assigned to colchicine ( 0.5 mg twice daily ) or placebo for 6 months .

METHODS

Theprimary endpoint was the proportion of patients achieving at least one-grade improvement in New York HeartAssociation class .

RESULTS

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 ) .

RESULTS

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 ) .

RESULTS

The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups ( p = 0.938 ) .

RESULTS

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 ) .

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 .

###24500245

null

OBJECTIVE

To examine the comparative antidepressant efficacy of S-adenosyl-L-methionine ( SAMe ) and escitalopram in a placebo-controlled , randomized , double-blind clinical trial .

METHODS

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 .

METHODS

Patients were randomized for 12 weeks to SAMe 1,600-3 ,200 mg/d , escitalopram 10-20 mg/d , or placebo .

METHODS

Doses were escalated at 6 weeks in the event of nonresponse .

METHODS

The main outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS-17 ) .

METHODS

Tolerability was assessed by the Systematic Assessment for Treatment of Emergent Events-Specific Inquiry ( SAFTEE-SI ) .

RESULTS

All 3 treatment arms demonstrated a significant improvement of about 5-6 points in HDRS-17 scores ( P < .001 for all ) , and no significant differences were observed between the treatment arms ( P > .05 for all ) .

RESULTS

Response rates in the intent-to-treat sample were 36 % for SAMe , 34 % for escitalopram , and 30 % for placebo .

RESULTS

Remission rates were 28 % for SAMe , 28 % for escitalopram , and 17 % for placebo .

RESULTS

No comparisons between treatment groups attained significance ( P > .05 for all ) .

RESULTS

Tolerability was good , with gastrointestinal side effects ( 19 % for stomach discomfort and 20 % for diarrhea ) as the most common in the SAMe arm .

RESULTS

Significant differences were observed between treatment groups for dizziness , anorgasmia , diminished mental acuity , and hot flashes ( P < .05 for all ) .

CONCLUSIONS

The results fail to support an advantage over placebo for either the investigational treatment SAMe or the standard treatment escitalopram for MDD .

BACKGROUND

ClinicalTrials.gov identifier : NCT00101452 .

###25833772

null

BACKGROUND

Total weight loss induced by energy restriction is highly variable even under tightly controlled conditions .

BACKGROUND

Identifying weight-loss discriminants would provide a valuable weight management tool and insights into body weight regulation .

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 .

METHODS

Data were derived from a controlled feeding trial investigating the effect of 3-4 dairy product servings in an energy-restricted diet ( 2092 kJ/d reduction ) over 12 wk .

METHODS

Partial least squares regression was used to identify weight-loss discriminants in 67 overweight and obese adults .

METHODS

Linear mixed models were developed to identify discriminant variable differences in high - vs. low-weight-loss responders .

RESULTS

Both pre - and postintervention variables ( n = 127 ) were identified as weight-loss discriminants ( root mean squared error of prediction = 1.85 kg ; Q ( 2 ) = 0.43 ) .

RESULTS

Compared with low-responders ( LR ) , high-responders ( HR ) had greater decreases in body weight ( LR : 2.7 1.6 kg ; HR : 9.4 1.8 kg , P < 0.01 ) , BMI ( in kg/m ( 2 ) ; LR : 1.0 0.6 ; HR : 3.3 0.5 , P < 0.01 ) , and total fat ( LR : 2.2 1.1 kg ; HR : 8.0 2.1 kg , P < 0.01 ) .

RESULTS

Significant group effects unaffected by the intervention were determined for the respiratory exchange ratio ( LR : 0.86 0.05 ; HR : 0.82 0.03 , P < 0.01 ) , moderate physical activity ( LR : 127 52 min ; HR : 167 68 min , P = 0.02 ) , sedentary activity ( LR : 1090 99 min ; HR : 1017 110 min , P = 0.02 ) , and plasma stearate [ LR : 102,000 21,000 quantifier ion peak height ( QIPH ) ; HR : 116,000 24,000 QIPH , P = 0.01 ] .

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 .

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 .