human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: St and ardized diagnostic criteria determined by the International Restless Legs Syndrome Study Group were used to investigate the current prevalence of restless legs syndrome ( RLS ) . Possible associations between RLS and neuropsychiatric and somatic complaints were also investigated . A r and om sample of 4,000 men living in central Sweden were sent a question naire that included questions about sleep habits , symptoms of sleepiness , and somatic and neuropsychiatric complaints . Four symptom questions accepted as minimal diagnostic criteria for RLS were also included . Odds ( OR ) ratios and 95 % confidence interval ( CI ) for different variables were calculated by means of multivariate logistic regression ; 5.8 % of the men suffered from RLS . The prevalence of RLS increased with age . Sleep-related complaints were more frequent among the RLS sufferers . Complaints of headache at awakening and daytime headache were reported three to five times more frequently among RLS sufferers and there was a tendency toward reported social isolation related to RLS . Subjects with RLS more frequently reported depressed mood ( OR , 2.6 ; 95 % CI , 1.8 - 3.8 ) , and complained more often of reduced libido ( OR , 2.2 ; 95 % CI , 1.4 - 3.3 ) . RLS sufferers more frequently reported hypertension ( OR , 1.5 ; 95 % CI , 0.9 - 2.4 ) and heart problems ( OR , 2.5 ; 95 % CI , 1.4 - 4.3 ) . Results show that restless legs syndrome is common among men . It is hypothesized that RLS may be associated with several somatic and neuropsychiatric symptoms OBJECTIVE To assess the efficacy , safety , and tolerability of ropinirole in the treatment of patients with restless legs syndrome . METHODS A 12 week , prospect i ve , double blind , r and omised comparison involving 284 patients from 10 European countries . All participants had a score of > or = 15 on the international restless legs scale ( IRLS ) . Patients were r and omised ( 1:1 ) to receive either ropinirole 0.25 - 4.0 mg once daily or placebo . The primary efficacy end point was mean change from baseline to week 12 in total IRLS score . Global improvements ( clinical global impression ( CGI ) scale ) and improvements in sleep , health related quality of life ( QoL ; using generic and disease specific measures ) , work , and other activities were also assessed . RESULTS 112/146 patients ( 76.7 % ) taking ropinirole and 109/138 ( 79.0 % ) taking placebo completed the study . Improvement in IRLS at week 12 with ropinirole ( mean ( SD ) dose , 1.90 ( 1.13 ) mg/day ) was greater than with placebo ( mean ( SE ) : -11.04 ( 0.719 ) v -8.03 ( 0.738 ) points ; adjusted difference = -3.01 ( 95 % confidence interval ( CI ) , -5.03 to -0.99 ) ; p = 0.0036 ) . More patients in the ropinirole group ( 53.4 % ) showed improvement on the CGI scale at week 12 than in the placebo group ( 40.9 % ; adjusted odds ratio = 1.7 ( 1.02 to 2.69 ) ; p = 0.0416 ) . Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1 . Ropinirole was also associated with significantly greater improvements in sleep and QoL end points . The most common adverse events were nausea and headache . CONCLUSIONS Ropinirole improves restless legs syndrome compared with placebo , with benefits apparent by week 1 . It is generally well tolerated Summary .In two 4-week polysomnography pilot studies with 10 patients each , we investigated the efficacy of oral lisuride as monotherapy in de novo RLS patients as well as in combination with levodopa in advanced RLS . Daily doses at study end were 0.3 mg lisuride , plus 150 mg levodopa in the combination study . Marked improvements occurred in both studies in different PLM indexes and in the CGI . Levodopa dose could be decreased by 27 % . Lisuride might be an efficacious treatment for RLS in general , and in combination with levodopa in advanced stage BACKGROUND Restless legs syndrome ( RLS ) is characterized by the desire to move the limbs associated with paresthesias of the legs , a motor restlessness , an intensification of symptoms at rest with relief by activity , and a worsening of symptoms in the evening or at night . Population -based studies are rare , and risk factors in the general population are not known . METHODS Cross-sectional survey with face-to-face interviews and physical examination among 4310 participants in the Study of Health in Pomerania in northeastern Germany . Participants were aged 20 to 79 years and were r and omly selected from population registers .  Restless legs syndrome was assessed with st and ardized , vali date d questions addressing the 4 minimal criteria for RLS as defined by the International Restless Legs Syndrome Study Group . RESULTS The overall prevalence of RLS was 10.6 % , increasing with age , and women were twice as often affected as men . While nulliparous women had prevalences similar to those among men up to age 64 years , the risk of RLS increased gradually for women with 1 child ( odds ratio , 1.98 ; 95 % confidence interval , 1.25 - 3.13 ) , 2 children ( odds ratio , 3.04 ; 95 % confidence interval , 2.11 - 4.40 ) , and 3 or more children ( odds ratio , 3.57 ; 95 % confidence interval , 2.30 - 5.55 ) . Subjects with RLS had significantly lower quality -of-life scores than those without the syndrome . CONCLUSIONS Restless legs syndrome is a common disease in the general population , affecting women more often than men . It is associated with reduced quality of life in cross-sectional analysis . Parity is a major factor in explaining the sex difference and may guide further clarification of the etiology of the disease In a double-blind r and omized crossover trial , oxycodone or placebo was given in divided night-time doses to 11 patients with idiopathic restless legs syndrome ( RLS ) for 2 weeks prior to appropriate polysomnographic studies . Under double-blinded conditions , patients were asked to do daily ratings of their leg sensations , motor restlessness and daytime alertness on a 1 - 4 scale for the 2 weeks prior to the polysomnographic studies and for the nights of the polysomnographic studies as well . Leg sensations ( p < 0.009 ) , motor restlessness ( p < 0.006 ) and daytime alertness ( p < 0.03 ) were significantly improved on oxycodone as compared to baseline or placebo . Patients were studied polysomnographically under double-blinded conditions for 2 nights in each phase of the protocol . On an average dose of 15.9 mg oxycodone ( equivalent to approximately three 5-mg tablets of commercial preparation ) , there was a statistically significant reduction in the number of periodic limb movements in sleep [ (PLMS)/hour sleep ( p < 0.004 ) ] and in the number of arousals/hour sleep ( p < 0.009 ) on drugs as compared to baseline or placebo . A statistically significant improvement was also noted in sleep efficiency ( p < 0.006 ) and 10 of the 11 patients preferred oxycodone over placebo . We conclude that oxycodone is an effective treatment for RLS and PLMS This r and omized , double-blinded , placebo-controlled trial ( NCT00135993 ) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome ( RLS ) over a 6-month maintenance period . A total of 505 eligible participants with moderate to severe RLS ( IRLS sum score > or= 15 ) were r and omly assigned to five groups to receive either placebo or rotigotine ( 0.5 , 1 , 2 , or 3 mg/24 hr ) delivered by once-daily transdermal patch ( fixed-dose regimen ) . The two co- primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions ( CGI-1 ) score . On both primary measures , 2 and 3 mg/24 hr rotigotine was superior to placebo ( P < 0.001 ) . Adjusted treatment differences to placebo for the IRLS sum score were -4.5 ( 95 % CI : -6.9 , -2.2 ) for 2 mg/24 hr rotigotine , -5.2 ( 95 % CI : -7.5 , -2.9 ) for 3 mg/24 hr rotigotine , and for CGI item 1 -0.65 ( 95 % CI : -1.0 , -0.3 ) and -0.9 ( 95 % CI : -1.3 , -0.5 ) for the 2 and 3 mg/24 hr doses , respectively . Skin reactions ( 27 % ) and known dopaminergic side effects such as nausea ( 18.1 % ) and headache ( 11.6 % ) were mostly mild or moderate in rotigotine subjects . Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms . Treatment efficacy was maintained throughout the 6-month double-blind period OBJECTIVES Patients with restless legs syndrome ( RLS ) have an elevated prevalence of mood disorders compared with the general population . We investigated the change of RLS-related mood impairment during treatment of RLS with pramipexole , a dopamine D(3)/D(2 ) agonist . METHODS Adults with moderate to very severe RLS were enrolled in a 12-week , double-blind , placebo-controlled Phase IV pramipexole trial . A moderate to very severe RLS-related mood disturbance at baseline ( score ≥2 on Item 10 of the International RLS Study Group Rating Scale [ IRLS ] ) was also required . Pramipexole ( 0.125 to 0.75 mg once daily ) was flexibly titrated over the first 4 weeks . RESULTS The intent-to-treat population comprised 199 patients on placebo and 203 on pramipexole . At week 12 , adjusted mean total-score changes on IRLS were -14.2±0.7 for pramipexole and -8.1±0.7 for placebo ( p<0.0001 ) , and on the Beck Depression Inventory version II , -7.3±0.4 for pramipexole and -5.8±0.5 for placebo ( p=0.0199 ) . For IRLS item 10 , the 12-week responder rate ( reduction to no or mild mood disturbance ) was 75.9 % for pramipexole and 57.3 % for placebo ( p<0.0001 ) . Study withdrawal rates were higher for placebo ( 20.5 % ) than for pramipexole ( 12.8 % ) . CONCLUSIONS In patients with RLS-related mood  disturbance , pramipexole improved RLS while also improving RLS-related mood impairment .  Tolerability of pramipexole was similar to that in previous studies BACKGROUND Patients with Restless Legs Syndrome ( RLS ) often seek treatment because of sleep problems related to nocturnal symptoms . Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms . METHODS Adults with moderate or severe RLS were r and omized to receive placebo or pramipexole ( flexibly titrated from 0.25 to 0.75 mg ) , 2 - 3h before bedtime for 12 weeks . The co- primary outcome measures were change in Medical Outcomes Study ( MOS ) sleep disturbance score and International RLS Study Group Rating Scale ( IRLS ) score at 12 weeks . RESULTS The intent-to-treat population included 357 patients : 178 received pramipexole and 179 received placebo .  At 12 weeks , the adjusted mean change from baseline was greater for pramipexole ( vs. placebo ) for IRLS score ( -13.4+/-0.7 vs. -9.6+/-0.7 ) and MOS sleep disturbance score ( -25.3+/-1.5 vs. -16.8+/-1.5 ) ( p < or=0.0001 ; ANCOVA ) . Responder rates ( clinical and patient global impression and IRLS ) were also significantly higher in the pramipexole group . RLS-QOL score was improved over placebo at Week 12 ( p<0.01 ) as were MOS sleep adequacy ( p=0.0008 ) and quantity ( p=0.08 ) scores . Nine percent of patients in each group withdrew because of adverse events . CONCLUSIONS Pramipexole is effective and well-tolerated for RLS and related sleep disturbance STUDY OBJECTIVES Polysomnographic study evaluating the efficacy of ropinirole for the treatment of patients with restless legs syndrome ( RLS ) suffering from periodic leg movements in sleep ( PLMS ) . DESIGN Double-blinded , placebo-controlled , parallel-group study . SETTING 15 tertiary referral cent 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: St and ardized diagnostic criteria determined by the International Restless Legs Syndrome Study Group were used to investigate the current prevalence of restless legs syndrome ( RLS ) . Possible associations between RLS and neuropsychiatric and somatic complaints were also investigated . A r and om sample of 4,000 men living in central Sweden were sent a question naire that included questions about sleep habits , symptoms of sleepiness , and somatic and neuropsychiatric complaints . Four symptom questions accepted as minimal diagnostic criteria for RLS were also included . Odds ( OR ) ratios and 95 % confidence interval ( CI ) for different variables were calculated by means of multivariate logistic regression ; 5.8 % of the men suffered from RLS . The prevalence of RLS increased with age . Sleep-related complaints were more frequent among the RLS sufferers . Complaints of headache at awakening and daytime headache were reported three to five times more frequently among RLS sufferers and there was a tendency toward reported social isolation related to RLS . Subjects with RLS more frequently reported depressed mood ( OR , 2.6 ; 95 % CI , 1.8 - 3.8 ) , and complained more often of reduced libido ( OR , 2.2 ; 95 % CI , 1.4 - 3.3 ) . RLS sufferers more frequently reported hypertension ( OR , 1.5 ; 95 % CI , 0.9 - 2.4 ) and heart problems ( OR , 2.5 ; 95 % CI , 1.4 - 4.3 ) . Results show that restless legs syndrome is common among men . It is hypothesized that RLS may be associated with several somatic and neuropsychiatric symptoms OBJECTIVE To assess the efficacy , safety , and tolerability of ropinirole in the treatment of patients with restless legs syndrome . METHODS A 12 week , prospect i ve , double blind , r and omised comparison involving 284 patients from 10 European countries . All participants had a score of > or = 15 on the international restless legs scale ( IRLS ) . Patients were r and omised ( 1:1 ) to receive either ropinirole 0.25 - 4.0 mg once daily or placebo . The primary efficacy end point was mean change from baseline to week 12 in total IRLS score . Global improvements ( clinical global impression ( CGI ) scale ) and improvements in sleep , health related quality of life ( QoL ; using generic and disease specific measures ) , work , and other activities were also assessed . RESULTS 112/146 patients ( 76.7 % ) taking ropinirole and 109/138 ( 79.0 % ) taking placebo completed the study . Improvement in IRLS at week 12 with ropinirole ( mean ( SD ) dose , 1.90 ( 1.13 ) mg/day ) was greater than with placebo ( mean ( SE ) : -11.04 ( 0.719 ) v -8.03 ( 0.738 ) points ; adjusted difference = -3.01 ( 95 % confidence interval ( CI ) , -5.03 to -0.99 ) ; p = 0.0036 ) . More patients in the ropinirole group ( 53.4 % ) showed improvement on the CGI scale at week 12 than in the placebo group ( 40.9 % ; adjusted odds ratio = 1.7 ( 1.02 to 2.69 ) ; p = 0.0416 ) . Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1 . Ropinirole was also associated with significantly greater improvements in sleep and QoL end points . The most common adverse events were nausea and headache . CONCLUSIONS Ropinirole improves restless legs syndrome compared with placebo , with benefits apparent by week 1 . It is generally well tolerated Summary .In two 4-week polysomnography pilot studies with 10 patients each , we investigated the efficacy of oral lisuride as monotherapy in de novo RLS patients as well as in combination with levodopa in advanced RLS . Daily doses at study end were 0.3 mg lisuride , plus 150 mg levodopa in the combination study . Marked improvements occurred in both studies in different PLM indexes and in the CGI . Levodopa dose could be decreased by 27 % . Lisuride might be an efficacious treatment for RLS in general , and in combination with levodopa in advanced stage BACKGROUND Restless legs syndrome ( RLS ) is characterized by the desire to move the limbs associated with paresthesias of the legs , a motor restlessness , an intensification of symptoms at rest with relief by activity , and a worsening of symptoms in the evening or at night . Population -based studies are rare , and risk factors in the general population are not known . METHODS Cross-sectional survey with face-to-face interviews and physical examination among 4310 participants in the Study of Health in Pomerania in northeastern Germany . Participants were aged 20 to 79 years and were r and omly selected from population registers .  Restless legs syndrome was assessed with st and ardized , vali date d questions addressing the 4 minimal criteria for RLS as defined by the International Restless Legs Syndrome Study Group . RESULTS The overall prevalence of RLS was 10.6 % , increasing with age , and women were twice as often affected as men . While nulliparous women had prevalences similar to those among men up to age 64 years , the risk of RLS increased gradually for women with 1 child ( odds ratio , 1.98 ; 95 % confidence interval , 1.25 - 3.13 ) , 2 children ( odds ratio , 3.04 ; 95 % confidence interval , 2.11 - 4.40 ) , and 3 or more children ( odds ratio , 3.57 ; 95 % confidence interval , 2.30 - 5.55 ) . Subjects with RLS had significantly lower quality -of-life scores than those without the syndrome . CONCLUSIONS Restless legs syndrome is a common disease in the general population , affecting women more often than men . It is associated with reduced quality of life in cross-sectional analysis . Parity is a major factor in explaining the sex difference and may guide further clarification of the etiology of the disease In a double-blind r and omized crossover trial , oxycodone or placebo was given in divided night-time doses to 11 patients with idiopathic restless legs syndrome ( RLS ) for 2 weeks prior to appropriate polysomnographic studies . Under double-blinded conditions , patients were asked to do daily ratings of their leg sensations , motor restlessness and daytime alertness on a 1 - 4 scale for the 2 weeks prior to the polysomnographic studies and for the nights of the polysomnographic studies as well . Leg sensations ( p < 0.009 ) , motor restlessness ( p < 0.006 ) and daytime alertness ( p < 0.03 ) were significantly improved on oxycodone as compared to baseline or placebo . Patients were studied polysomnographically under double-blinded conditions for 2 nights in each phase of the protocol . On an average dose of 15.9 mg oxycodone ( equivalent to approximately three 5-mg tablets of commercial preparation ) , there was a statistically significant reduction in the number of periodic limb movements in sleep [ (PLMS)/hour sleep ( p < 0.004 ) ] and in the number of arousals/hour sleep ( p < 0.009 ) on drugs as compared to baseline or placebo . A statistically significant improvement was also noted in sleep efficiency ( p < 0.006 ) and 10 of the 11 patients preferred oxycodone over placebo . We conclude that oxycodone is an effective treatment for RLS and PLMS This r and omized , double-blinded , placebo-controlled trial ( NCT00135993 ) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome ( RLS ) over a 6-month maintenance period . A total of 505 eligible participants with moderate to severe RLS ( IRLS sum score > or= 15 ) were r and omly assigned to five groups to receive either placebo or rotigotine ( 0.5 , 1 , 2 , or 3 mg/24 hr ) delivered by once-daily transdermal patch ( fixed-dose regimen ) . The two co- primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions ( CGI-1 ) score . On both primary measures , 2 and 3 mg/24 hr rotigotine was superior to placebo ( P < 0.001 ) . Adjusted treatment differences to placebo for the IRLS sum score were -4.5 ( 95 % CI : -6.9 , -2.2 ) for 2 mg/24 hr rotigotine , -5.2 ( 95 % CI : -7.5 , -2.9 ) for 3 mg/24 hr rotigotine , and for CGI item 1 -0.65 ( 95 % CI : -1.0 , -0.3 ) and -0.9 ( 95 % CI : -1.3 , -0.5 ) for the 2 and 3 mg/24 hr doses , respectively . Skin reactions ( 27 % ) and known dopaminergic side effects such as nausea ( 18.1 % ) and headache ( 11.6 % ) were mostly mild or moderate in rotigotine subjects . Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms . Treatment efficacy was maintained throughout the 6-month double-blind period OBJECTIVES Patients with restless legs syndrome ( RLS ) have an elevated prevalence of mood disorders compared with the general population . We investigated the change of RLS-related mood impairment during treatment of RLS with pramipexole , a dopamine D(3)/D(2 ) agonist . METHODS Adults with moderate to very severe RLS were enrolled in a 12-week , double-blind , placebo-controlled Phase IV pramipexole trial . A moderate to very severe RLS-related mood disturbance at baseline ( score ≥2 on Item 10 of the International RLS Study Group Rating Scale [ IRLS ] ) was also required . Pramipexole ( 0.125 to 0.75 mg once daily ) was flexibly titrated over the first 4 weeks . RESULTS The intent-to-treat population comprised 199 patients on placebo and 203 on pramipexole . At week 12 , adjusted mean total-score changes on IRLS were -14.2±0.7 for pramipexole and -8.1±0.7 for placebo ( p<0.0001 ) , and on the Beck Depression Inventory version II , -7.3±0.4 for pramipexole and -5.8±0.5 for placebo ( p=0.0199 ) . For IRLS item 10 , the 12-week responder rate ( reduction to no or mild mood disturbance ) was 75.9 % for pramipexole and 57.3 % for placebo ( p<0.0001 ) . Study withdrawal rates were higher for placebo ( 20.5 % ) than for pramipexole ( 12.8 % ) . CONCLUSIONS In patients with RLS-related mood  disturbance , pramipexole improved RLS while also improving RLS-related mood impairment .  Tolerability of pramipexole was similar to that in previous studies BACKGROUND Patients with Restless Legs Syndrome ( RLS ) often seek treatment because of sleep problems related to nocturnal symptoms . Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms . METHODS Adults with moderate or severe RLS were r and omized to receive placebo or pramipexole ( flexibly titrated from 0.25 to 0.75 mg ) , 2 - 3h before bedtime for 12 weeks . The co- primary outcome measures were change in Medical Outcomes Study ( MOS ) sleep disturbance score and International RLS Study Group Rating Scale ( IRLS ) score at 12 weeks . RESULTS The intent-to-treat population included 357 patients : 178 received pramipexole and 179 received placebo .  At 12 weeks , the adjusted mean change from baseline was greater for pramipexole ( vs. placebo ) for IRLS score ( -13.4+/-0.7 vs. -9.6+/-0.7 ) and MOS sleep disturbance score ( -25.3+/-1.5 vs. -16.8+/-1.5 ) ( p < or=0.0001 ; ANCOVA ) . Responder rates ( clinical and patient global impression and IRLS ) were also significantly higher in the pramipexole group . RLS-QOL score was improved over placebo at Week 12 ( p<0.01 ) as were MOS sleep adequacy ( p=0.0008 ) and quantity ( p=0.08 ) scores . Nine percent of patients in each group withdrew because of adverse events . CONCLUSIONS Pramipexole is effective and well-tolerated for RLS and related sleep disturbance STUDY OBJECTIVES Polysomnographic study evaluating the efficacy of ropinirole for the treatment of patients with restless legs syndrome ( RLS ) suffering from periodic leg movements in sleep ( PLMS ) . DESIGN Double-blinded , placebo-controlled , parallel-group study . SETTING 15 tertiary referral cent 
    Output:
    