id
stringlengths 1
5
| document_id
stringlengths 5
8
| passages
list | entities
list | events
sequence | coreferences
sequence | relations
sequence |
|---|---|---|---|---|---|---|
70952 | 25865294 | [
{
"id": "70953",
"type": "document",
"text": [
"Oxytocin reduces caloric intake in men . OBJECTIVE Preclinical studies indicate that oxytocin is anorexigenic and has beneficial metabolic effects . Oxytocin effects on nutrition and metabolism in humans are not well defined . It was hypothesized that oxytocin would reduce caloric intake and appetite and alter levels of appetite-regulating hormones . Metabolic effects of oxytocin were also explored . METHODS A randomized , placebo-controlled crossover study of single-dose intranasal oxytocin ( 24 IU ) in 25 fasting healthy men was performed . After oxytocin/placebo , subjects selected breakfast from a menu and were given double portions . Caloric content of food consumed was measured . Visual analog scales were used to assess appetite , and blood was drawn for appetite-regulating hormones , insulin , and glucose before and after oxytocin/placebo . Indirect calorimetry assessed resting energy expenditure ( REE ) and substrate utilization . RESULTS Oxytocin reduced caloric intake with a preferential effect on fat intake and increased levels of the anorexigenic hormone cholecystokinin without affecting appetite or other appetite-regulating hormones . There was no effect of oxytocin on REE . Oxytocin resulted in a shift from carbohydrate to fat utilization and improved insulin sensitivity . CONCLUSIONS Intranasal oxytocin reduces caloric intake and has beneficial metabolic effects in men without concerning side effects . The efficacy and safety of sustained oxytocin administration in the treatment of obesity warrants investigation ."
],
"offsets": [
[
0,
1554
]
]
}
] | [
{
"id": "70954",
"type": "Intervention_Pharmacological",
"text": [
"Oxytocin"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "70955",
"type": "Intervention_Pharmacological",
"text": [
"oxytocin"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "70956",
"type": "Intervention_Pharmacological",
"text": [
"Oxytocin"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "70957",
"type": "Intervention_Pharmacological",
"text": [
"oxytocin"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "70958",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
427,
445
]
],
"normalized": []
},
{
"id": "70959",
"type": "Intervention_Pharmacological",
"text": [
"single-dose intranasal oxytocin ( 24 IU )"
],
"offsets": [
[
465,
506
]
],
"normalized": []
},
{
"id": "70960",
"type": "Intervention_Pharmacological",
"text": [
"oxytocin/placebo"
],
"offsets": [
[
555,
571
]
],
"normalized": []
},
{
"id": "70961",
"type": "Intervention_Physical",
"text": [
"selected breakfast from a menu and were given double portions"
],
"offsets": [
[
583,
644
]
],
"normalized": []
},
{
"id": "70962",
"type": "Intervention_Pharmacological",
"text": [
"."
],
"offsets": [
[
39,
40
]
],
"normalized": []
},
{
"id": "70963",
"type": "Intervention_Physical",
"text": [
"Caloric content of food consumed was measured"
],
"offsets": [
[
647,
692
]
],
"normalized": []
},
{
"id": "70964",
"type": "Intervention_Physical",
"text": [
"blood was drawn for appetite-regulating hormones"
],
"offsets": [
[
751,
799
]
],
"normalized": []
},
{
"id": "70965",
"type": "Intervention_Physical",
"text": [
"insulin"
],
"offsets": [
[
802,
809
]
],
"normalized": []
},
{
"id": "70966",
"type": "Intervention_Physical",
"text": [
"glucose before and after oxytocin/placebo"
],
"offsets": [
[
816,
857
]
],
"normalized": []
},
{
"id": "70967",
"type": "Intervention_Pharmacological",
"text": [
"Oxytocin"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "70968",
"type": "Intervention_Pharmacological",
"text": [
"Oxytocin"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "70969",
"type": "Intervention_Pharmacological",
"text": [
"oxytocin"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "70970",
"type": "Intervention_Pharmacological",
"text": [
"oxytocin"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "70971",
"type": "Participant_Sex",
"text": [
"men ."
],
"offsets": [
[
35,
40
]
],
"normalized": []
},
{
"id": "70972",
"type": "Participant_Sample-size",
"text": [
"25"
],
"offsets": [
[
510,
512
]
],
"normalized": []
},
{
"id": "70973",
"type": "Participant_Condition",
"text": [
"fasting healthy"
],
"offsets": [
[
513,
528
]
],
"normalized": []
},
{
"id": "70974",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
35,
38
]
],
"normalized": []
},
{
"id": "70975",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
35,
38
]
],
"normalized": []
}
] | [] | [] | [] |
70976 | 2586565 | [
{
"id": "70977",
"type": "document",
"text": [
"Peritoneovenous shunting as compared with medical treatment in patients with alcoholic cirrhosis and massive ascites . Veterans Administration Cooperative Study on Treatment of Alcoholic Cirrhosis with Ascites . The optimal management of severe ascites in patients with alcoholic cirrhosis has not been defined . in a 5 1/2-year study , we randomly assigned 299 men with alcoholic cirrhosis , who had persistent or recurrent severe ascites despite a standard medical regimen , to receive either intensive medical treatment or peritoneovenous ( LeVeen ) shunting . We identified three risk groups : Group 1 had normal or mildly abnormal results on liver-function tests , Group 2 had more severe liver dysfunction or previous complications , and Group 3 had severe prerenal azotemia without kidney disease . For the patients who received the medical treatment and those who received the surgical treatment combined , the median survival times were 1093 days in Group 1 , 222 days in Group 2 , and 37 days in Group 3 ( P less than or equal to 0.01 ) for all comparisons ) . For all the groups combined , the median time to the resolution of ascites was 5.4 weeks for medical patients and 3.0 weeks for surgical patients ( P less than 0.01 ) . Within each risk group , mortality during the initial hospitalization and median long-term survival were similar among patients receiving either treatment . However , the median time to the recurrence of ascites in Group 1 was 4 months in medical patients , as compared with 18 months in surgical patients ( P = 0.01 ) ; in Group 2 it was 3 months in medical patients as compared with 12 months in surgical patients ( P = 0.04 ) . The median duration of hospitalization was longer in medical patients than in surgical patients ( 6.1 vs. 2.4 weeks in Group 1 [ P less than 0.001 ] and 5.0 vs. 3.1 weeks in Group 2 [ P less than 0.01 ] ) . Group 3 was too small to permit a meaningful comparison . During the initial hospitalization , the incidence of infections , gastrointestinal bleeding , and encephalopathy was similar among the medical and surgical patients . We conclude that peritoneovenous shunting alleviated disabling ascites more rapidly than medical management . However , survival was closely related to the severity of the illness at the time of randomization and was not altered by shunting ."
],
"offsets": [
[
0,
2346
]
]
}
] | [
{
"id": "70978",
"type": "Intervention_Physical",
"text": [
"Peritoneovenous shunting"
],
"offsets": [
[
0,
24
]
],
"normalized": []
},
{
"id": "70979",
"type": "Intervention_Pharmacological",
"text": [
"medical treatment"
],
"offsets": [
[
42,
59
]
],
"normalized": []
},
{
"id": "70980",
"type": "Intervention_Pharmacological",
"text": [
"intensive medical treatment"
],
"offsets": [
[
495,
522
]
],
"normalized": []
},
{
"id": "70981",
"type": "Intervention_Surgical",
"text": [
"peritoneovenous ( LeVeen ) shunting"
],
"offsets": [
[
526,
561
]
],
"normalized": []
},
{
"id": "70982",
"type": "Outcome_Mortality",
"text": [
"mortality"
],
"offsets": [
[
1265,
1274
]
],
"normalized": []
},
{
"id": "70983",
"type": "Outcome_Mortality",
"text": [
"median long-term survival"
],
"offsets": [
[
1314,
1339
]
],
"normalized": []
},
{
"id": "70984",
"type": "Outcome_Physical",
"text": [
"recurrence of ascites"
],
"offsets": [
[
1430,
1451
]
],
"normalized": []
},
{
"id": "70985",
"type": "Outcome_Other",
"text": [
"median duration of hospitalization"
],
"offsets": [
[
1675,
1709
]
],
"normalized": []
},
{
"id": "70986",
"type": "Outcome_Adverse-effects",
"text": [
"incidence of infections , gastrointestinal bleeding , and encephalopathy"
],
"offsets": [
[
1977,
2049
]
],
"normalized": []
},
{
"id": "70987",
"type": "Outcome_Physical",
"text": [
"disabling ascites"
],
"offsets": [
[
2157,
2174
]
],
"normalized": []
},
{
"id": "70988",
"type": "Outcome_Mortality",
"text": [
"survival"
],
"offsets": [
[
926,
934
]
],
"normalized": []
},
{
"id": "70989",
"type": "Participant_Condition",
"text": [
"patients with alcoholic cirrhosis and massive ascites ."
],
"offsets": [
[
63,
118
]
],
"normalized": []
},
{
"id": "70990",
"type": "Participant_Condition",
"text": [
"patients with alcoholic cirrhosis"
],
"offsets": [
[
63,
96
]
],
"normalized": []
}
] | [] | [] | [] |
70991 | 25865762 | [
{
"id": "70992",
"type": "document",
"text": [
"A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty . BACKGROUND Annular stabilization is important during bicuspid aortic valve ( BAV ) repair to obtain the best long-term results . This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose . METHODS Under regulatory supervision ( NCT02071849 ) , a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients . Three patients had Sievers type 0 valves , 11 had Sievers type 1 , and 2 had Sievers type 2 . Thirteen patients had left-/right-coronary cusp fusion , 1 had right-/noncoronary cusp fusion , and 2 had both . Moderate to severe aortic insufficiency ( AI ) was present in 13 of 16 patients , and 3 had mild AI with aortic aneurysms . Ascending aortic aneurysms , root aneurysms , or both were replaced in 7 of 16 patients . The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference . The ring was implanted into the annulus beneath the valve , and then leaflet repair was performed . RESULTS Immediate postrepair echocardiograms showed grade 0 residual AI in all patients , with good cusp mobility and effective height , and satisfactory gradients . There were no in-hospital or late mortalities . Two patients experienced leaflet tears from long annular suture tails , requiring late valve replacement . After implementation of a lateral suture fixation technique , no more failures occurred . At a mean follow-up time of 9 months , the remaining 14 patients were in New York Heart Association class I , with predominant grade 0 AI . CONCLUSIONS As a technique for BAV repair , internal ring annuloplasty produces major annular remodeling and stabilization . Annular reduction and reshaping to a 50/50 % symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation . Geometric ring annuloplasty could have useful applications in BAV repair ."
],
"offsets": [
[
0,
2012
]
]
}
] | [
{
"id": "70993",
"type": "Intervention_Surgical",
"text": [
"Geometric Ring Annuloplasty"
],
"offsets": [
[
63,
90
]
],
"normalized": []
},
{
"id": "70994",
"type": "Intervention_Surgical",
"text": [
"geometric bicuspid annuloplasty ring"
],
"offsets": [
[
377,
413
]
],
"normalized": []
},
{
"id": "70995",
"type": "Intervention_Physical",
"text": [
"Dacron-covered titanium ring"
],
"offsets": [
[
885,
913
]
],
"normalized": []
},
{
"id": "70996",
"type": "Outcome_Other",
"text": [
"Immediate postrepair echocardiograms showed grade 0 residual"
],
"offsets": [
[
1139,
1199
]
],
"normalized": []
},
{
"id": "70997",
"type": "Outcome_Other",
"text": [
"cusp mobility and effective height , and satisfactory gradients"
],
"offsets": [
[
1231,
1294
]
],
"normalized": []
},
{
"id": "70998",
"type": "Outcome_Adverse-effects",
"text": [
"no in-hospital or late mortalities"
],
"offsets": [
[
1308,
1342
]
],
"normalized": []
},
{
"id": "70999",
"type": "Outcome_Adverse-effects",
"text": [
"experienced leaflet tears"
],
"offsets": [
[
1358,
1383
]
],
"normalized": []
},
{
"id": "71000",
"type": "Outcome_Adverse-effects",
"text": [
"requiring late valve replacement"
],
"offsets": [
[
1417,
1449
]
],
"normalized": []
},
{
"id": "71001",
"type": "Outcome_Other",
"text": [
"more failures"
],
"offsets": [
[
1517,
1530
]
],
"normalized": []
},
{
"id": "71002",
"type": "Outcome_Other",
"text": [
"in New York Heart Association class"
],
"offsets": [
[
1612,
1647
]
],
"normalized": []
},
{
"id": "71003",
"type": "Outcome_Other",
"text": [
"predominant grade 0 AI"
],
"offsets": [
[
1657,
1679
]
],
"normalized": []
},
{
"id": "71004",
"type": "Participant_Condition",
"text": [
"valve repair"
],
"offsets": [
[
430,
442
]
],
"normalized": []
},
{
"id": "71005",
"type": "Participant_Sample-size",
"text": [
"16"
],
"offsets": [
[
446,
448
]
],
"normalized": []
},
{
"id": "71006",
"type": "Participant_Sample-size",
"text": [
"Three patients"
],
"offsets": [
[
460,
474
]
],
"normalized": []
},
{
"id": "71007",
"type": "Participant_Sample-size",
"text": [
"11"
],
"offsets": [
[
503,
505
]
],
"normalized": []
},
{
"id": "71008",
"type": "Participant_Sample-size",
"text": [
"2"
],
"offsets": [
[
363,
364
]
],
"normalized": []
},
{
"id": "71009",
"type": "Participant_Sample-size",
"text": [
"Thirteen patients"
],
"offsets": [
[
554,
571
]
],
"normalized": []
}
] | [] | [] | [] |
71010 | 25865864 | [
{
"id": "71011",
"type": "document",
"text": [
"Fall rates in hospital rehabilitation units after individualised patient and staff education programmes : a pragmatic , stepped-wedge , cluster-randomised controlled trial . BACKGROUND Falls are the most frequent adverse events that are reported in hospitals . We examined the effectiveness of individualised falls-prevention education for patients , supported by training and feedback for staff , delivered as a ward-level programme . METHODS Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge , cluster-randomised study , undertaken during a 50 week period . Units were randomly assigned to intervention or control groups by use of computer-generated , random allocation sequences . We included patients admitted to the unit during the study with a Mini-Mental State Examination ( MMSE ) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional , in addition to usual care . We provided information about patients ' goals , feedback about the ward environment , and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients . The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers . All analyses were by intention to treat . This trial is registered with the Australian New Zealand Clinical Trials registry , number ACTRN12612000877886 ) . FINDINGS Between Jan 13 , and Dec 27 , 2013 , 3606 patients were admitted to the eight units ( n=1983 control period ; n=1623 intervention period ) . There were fewer falls ( n=196 , 7·80/1000 patient-days vs n=380 , 13·78/1000 patient-days , adjusted rate ratio 0·60 [ robust 95 % CI 0·42-0·94 ] , p=0·003 ) , injurious falls ( n=66 , 2·63/1000 patient-days vs 131 , 4·75/1000 patient-days , 0·65 [ robust 95 % CI 0·42-0·88 ] , p=0·006 ) , and fallers ( n=136 [ 8·38 % ] vs n=248 [ 12·51 % ] adjusted odds ratio 0·55 [ robust 95 % CI 0·38 to 0·81 ] , p=0·003 ) in the intervention compared with the control group . There was no significant difference in length of stay ( intervention median 11 days [ IQR 7-19 ] , control 10 days [ 6-18 ] ) . INTERPRETATION Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units . FUNDING State Health Research Advisory Council , Department of Health , Government of Western Australia ."
],
"offsets": [
[
0,
2612
]
]
}
] | [
{
"id": "71012",
"type": "Intervention_Educational",
"text": [
"individualised patient and staff education programmes :"
],
"offsets": [
[
50,
105
]
],
"normalized": []
},
{
"id": "71013",
"type": "Intervention_Educational",
"text": [
"individualised falls-prevention education for patients"
],
"offsets": [
[
294,
348
]
],
"normalized": []
},
{
"id": "71014",
"type": "Intervention_Educational",
"text": [
"training and feedback for staff"
],
"offsets": [
[
364,
395
]
],
"normalized": []
},
{
"id": "71015",
"type": "Intervention_Educational",
"text": [
"control"
],
"offsets": [
[
155,
162
]
],
"normalized": []
},
{
"id": "71016",
"type": "Intervention_Educational",
"text": [
"individualised education"
],
"offsets": [
[
871,
895
]
],
"normalized": []
},
{
"id": "71017",
"type": "Intervention_Educational",
"text": [
"information about patients ' goals , feedback about the ward environment , and perceived barriers to engagement in falls-prevention strategies"
],
"offsets": [
[
1033,
1175
]
],
"normalized": []
},
{
"id": "71018",
"type": "Outcome_Physical",
"text": [
"Fall rates"
],
"offsets": [
[
0,
10
]
],
"normalized": []
},
{
"id": "71019",
"type": "Outcome_Mental",
"text": [
"health behaviour"
],
"offsets": [
[
939,
955
]
],
"normalized": []
},
{
"id": "71020",
"type": "Outcome_Physical",
"text": [
"patient rate of falls per 1000 patient-days"
],
"offsets": [
[
1288,
1331
]
],
"normalized": []
},
{
"id": "71021",
"type": "Outcome_Other",
"text": [
"proportion of patients who were fallers ."
],
"offsets": [
[
1340,
1381
]
],
"normalized": []
},
{
"id": "71022",
"type": "Outcome_Physical",
"text": [
"falls"
],
"offsets": [
[
309,
314
]
],
"normalized": []
},
{
"id": "71023",
"type": "Outcome_Other",
"text": [
"significant difference"
],
"offsets": [
[
2168,
2190
]
],
"normalized": []
},
{
"id": "71024",
"type": "Participant_Condition",
"text": [
"hospital rehabilitation units"
],
"offsets": [
[
14,
43
]
],
"normalized": []
},
{
"id": "71025",
"type": "Participant_Sample-size",
"text": [
"Eight"
],
"offsets": [
[
444,
449
]
],
"normalized": []
},
{
"id": "71026",
"type": "Participant_Condition",
"text": [
"Mini-Mental State Examination ( MMSE"
],
"offsets": [
[
796,
832
]
],
"normalized": []
},
{
"id": "71027",
"type": "Participant_Sample-size",
"text": [
"3606"
],
"offsets": [
[
1585,
1589
]
],
"normalized": []
},
{
"id": "71028",
"type": "Participant_Sample-size",
"text": [
"n=1983"
],
"offsets": [
[
1634,
1640
]
],
"normalized": []
},
{
"id": "71029",
"type": "Participant_Sample-size",
"text": [
"n=1623"
],
"offsets": [
[
1658,
1664
]
],
"normalized": []
},
{
"id": "71030",
"type": "Participant_Condition",
"text": [
"injurious falls in older patients in rehabilitation"
],
"offsets": [
[
2438,
2489
]
],
"normalized": []
}
] | [] | [] | [] |
71031 | 25871593 | [
{
"id": "71032",
"type": "document",
"text": [
"Feasibility of a sensory-adapted dental environment for children with autism . OBJECTIVE To provide an example of an occupational therapy feasibility study and evaluate the implementation of a randomized controlled pilot and feasibility trial examining the impact of a sensory-adapted dental environment ( SADE ) to enhance oral care for children with autism spectrum disorder ( ASD ) . METHOD Twenty-two children with ASD and 22 typically developing children , ages 6-12 yr , attended a dental clinic in an urban hospital . Participants completed two dental cleanings , 3-4 mo apart , one in a regular environment and one in a SADE . Feasibility outcome measures were recruitment , retention , accrual , dropout , and protocol adherence . Intervention outcome measures were physiological stress , behavioral distress , pain , and cost . RESULTS We successfully recruited and retained participants . Parents expressed satisfaction with research study participation . Dentists stated that the intervention could be incorporated in normal practice . Intervention outcome measures favored the SADE condition . CONCLUSION Preliminary positive benefit of SADE in children with ASD warrants moving forward with a large-scale clinical trial ."
],
"offsets": [
[
0,
1235
]
]
}
] | [
{
"id": "71033",
"type": "Intervention_Physical",
"text": [
"two dental cleanings"
],
"offsets": [
[
548,
568
]
],
"normalized": []
},
{
"id": "71034",
"type": "Intervention_Physical",
"text": [
"3-4 mo apart"
],
"offsets": [
[
571,
583
]
],
"normalized": []
},
{
"id": "71035",
"type": "Intervention_Physical",
"text": [
"one in a regular environment and one in a SADE"
],
"offsets": [
[
586,
632
]
],
"normalized": []
},
{
"id": "71036",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
56,
64
]
],
"normalized": []
},
{
"id": "71037",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
70,
76
]
],
"normalized": []
},
{
"id": "71038",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
56,
64
]
],
"normalized": []
},
{
"id": "71039",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder ( ASD ) ."
],
"offsets": [
[
352,
386
]
],
"normalized": []
},
{
"id": "71040",
"type": "Participant_Sample-size",
"text": [
"Twenty-two"
],
"offsets": [
[
394,
404
]
],
"normalized": []
},
{
"id": "71041",
"type": "Participant_Condition",
"text": [
"ASD"
],
"offsets": [
[
379,
382
]
],
"normalized": []
},
{
"id": "71042",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
56,
64
]
],
"normalized": []
},
{
"id": "71043",
"type": "Participant_Age",
"text": [
"ages 6-12 yr"
],
"offsets": [
[
462,
474
]
],
"normalized": []
},
{
"id": "71044",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
56,
64
]
],
"normalized": []
},
{
"id": "71045",
"type": "Participant_Condition",
"text": [
"ASD"
],
"offsets": [
[
379,
382
]
],
"normalized": []
}
] | [] | [] | [] |
71046 | 25885180 | [
{
"id": "71047",
"type": "document",
"text": [
"Effect of cool vs. warm dialysate on toxin removal : rationale and study design . BACKGROUND Cool dialysate is often recommended for prevention of intra-dialytic hypotensive episodes in maintenance hemodialysis ( HD ) patients . However , its effect on toxin removal is not studied . It is known that inter-compartmental resistance is the main barrier for toxin removal . Cool dialysate can potentially increase this resistance by vasoconstriction and thus impair the toxin removal . The aim of this trial is to compare the toxin removal outcome associated with cool vs. warm dialysate . METHOD/DESIGN This study is based on the hypothesis that dialysate temperature , a potential maneuver to maintain hemodynamic stability during HD , may influence inter-compartmental resistance and hence , toxin removal . Only stable HD patients will be recruited for this study . The quantum of removed toxins will be assessed by the total spent dialysate , which is a gold standard to quantify the efficacy of a single dialysis session . Collected samples will be analyzed for urea , creatinine , phosphate , β2-microglobulin , and uric acid . The study is a single center , self-controlled , randomized prospective clinical research where 20 study subjects will undergo 2 dialysis sessions : ( a ) cool dialysis with dialysate at 35.5°C , and ( b ) warm dialysis with dialysate at 37°C . Pre- and post-dialysis blood samples will be collected to quantify the dialysis adequacy and toxin reduction ratio . DISCUSSION This is the first clinical research to investigate the effect of dialysate temperature on removal of both small and large-sized toxins . Successful completion of this research will provide important knowledge pertaining to dialysate temperature prescription . Results can also lead to the hypothesis that cool dialysate may help in by preventing intra-dialytic hypotensive episodes , but prolonged prescription of cool dialysate may lead to comorbidities associated with excess toxin accumulation . The new knowledge will encourage for personalized dialysate temperature profiling . TRIAL REGISTRATION Clinicaltrials.gov Identifier -- NCT02064153 ."
],
"offsets": [
[
0,
2154
]
]
}
] | [
{
"id": "71048",
"type": "Intervention_Physical",
"text": [
"cool"
],
"offsets": [
[
10,
14
]
],
"normalized": []
},
{
"id": "71049",
"type": "Intervention_Physical",
"text": [
"warm dialysate"
],
"offsets": [
[
19,
33
]
],
"normalized": []
},
{
"id": "71050",
"type": "Intervention_Physical",
"text": [
"Cool dialysate"
],
"offsets": [
[
93,
107
]
],
"normalized": []
},
{
"id": "71051",
"type": "Intervention_Physical",
"text": [
"Cool dialysate"
],
"offsets": [
[
93,
107
]
],
"normalized": []
},
{
"id": "71052",
"type": "Intervention_Physical",
"text": [
"cool"
],
"offsets": [
[
10,
14
]
],
"normalized": []
},
{
"id": "71053",
"type": "Intervention_Physical",
"text": [
"warm dialysate"
],
"offsets": [
[
19,
33
]
],
"normalized": []
},
{
"id": "71054",
"type": "Participant_Condition",
"text": [
"toxin removal"
],
"offsets": [
[
37,
50
]
],
"normalized": []
},
{
"id": "71055",
"type": "Participant_Condition",
"text": [
"maintenance hemodialysis ( HD ) patients ."
],
"offsets": [
[
186,
228
]
],
"normalized": []
},
{
"id": "71056",
"type": "Participant_Condition",
"text": [
"Only stable HD patients"
],
"offsets": [
[
809,
832
]
],
"normalized": []
},
{
"id": "71057",
"type": "Participant_Sample-size",
"text": [
"20"
],
"offsets": [
[
1229,
1231
]
],
"normalized": []
}
] | [] | [] | [] |
71058 | 25887586 | [
{
"id": "71059",
"type": "document",
"text": [
"Femoral neck osteotomy guide for total hip arthroplasty . BACKGROUND Total hip arthroplasty ( THA ) is a common last-resort treatment for hip disease , but postoperative patients often complain of discrepancies in leg length . This study introduces a device designed to increase the precision of the femoral neck osteotomy and reduce the incidence of leg length discrepancy . METHODS Forty-eight patients undergoing THA were divided into two groups , with and without the use of the femoral osteotomy guide . All operations were performed through a posterolateral approach . Differences in leg length were recorded before and after the operation . Measurements were also made to compare the preoperative plan with the actual amount of bone removed . RESULTS The mean average difference in femoral neck resection height was 0.84 mm when using the osteotomy guide and 1.69 mm without the guide . Discrepancies in postoperative leg length were 5.45 mm and 13.37 mm in the groups with and without the guide , respectively . CONCLUSION The femoral neck osteotomy guide is an effectively auxiliary tool for increasing the accuracy of bone resection in arthroplasty using the posterolateral approach . TRIAL REGISTRATION ChiCTR-OOC-15005904 ; date : 2015-01-30 ."
],
"offsets": [
[
0,
1255
]
]
}
] | [
{
"id": "71060",
"type": "Intervention_Surgical",
"text": [
"Total hip arthroplasty ( THA )"
],
"offsets": [
[
69,
99
]
],
"normalized": []
},
{
"id": "71061",
"type": "Intervention_Surgical",
"text": [
"THA"
],
"offsets": [
[
94,
97
]
],
"normalized": []
},
{
"id": "71062",
"type": "Intervention_Educational",
"text": [
"femoral osteotomy guide"
],
"offsets": [
[
483,
506
]
],
"normalized": []
},
{
"id": "71063",
"type": "Outcome_Physical",
"text": [
"precision of the femoral neck osteotomy"
],
"offsets": [
[
283,
322
]
],
"normalized": []
},
{
"id": "71064",
"type": "Outcome_Physical",
"text": [
"leg length discrepancy"
],
"offsets": [
[
351,
373
]
],
"normalized": []
},
{
"id": "71065",
"type": "Outcome_Physical",
"text": [
"Differences in leg length"
],
"offsets": [
[
575,
600
]
],
"normalized": []
},
{
"id": "71066",
"type": "Outcome_Physical",
"text": [
"actual amount of bone removed ."
],
"offsets": [
[
718,
749
]
],
"normalized": []
},
{
"id": "71067",
"type": "Outcome_Physical",
"text": [
"mean average difference in femoral neck resection height"
],
"offsets": [
[
762,
818
]
],
"normalized": []
},
{
"id": "71068",
"type": "Outcome_Other",
"text": [
"guide ."
],
"offsets": [
[
501,
508
]
],
"normalized": []
},
{
"id": "71069",
"type": "Outcome_Physical",
"text": [
"Discrepancies in postoperative leg length"
],
"offsets": [
[
894,
935
]
],
"normalized": []
},
{
"id": "71070",
"type": "Outcome_Physical",
"text": [
"accuracy of bone resection"
],
"offsets": [
[
1116,
1142
]
],
"normalized": []
},
{
"id": "71071",
"type": "Participant_Condition",
"text": [
"total hip arthroplasty"
],
"offsets": [
[
33,
55
]
],
"normalized": []
},
{
"id": "71072",
"type": "Participant_Condition",
"text": [
"postoperative"
],
"offsets": [
[
156,
169
]
],
"normalized": []
},
{
"id": "71073",
"type": "Participant_Sample-size",
"text": [
"Forty-eight"
],
"offsets": [
[
384,
395
]
],
"normalized": []
},
{
"id": "71074",
"type": "Participant_Condition",
"text": [
"arthroplasty using the posterolateral approach"
],
"offsets": [
[
1146,
1192
]
],
"normalized": []
}
] | [] | [] | [] |
71075 | 25888263 | [
{
"id": "71076",
"type": "document",
"text": [
"Effect of enzalutamide on health-related quality of life , pain , and skeletal-related events in asymptomatic and minimally symptomatic , chemotherapy-naive patients with metastatic castration-resistant prostate cancer ( PREVAIL ) : results from a randomised , phase 3 trial . BACKGROUND Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic , chemotherapy-naive patients with metastatic castration-resistant prostate cancer . We report the effect of enzalutamide on health-related quality of life ( HRQoL ) , pain , and skeletal-related events observed during this trial . METHODS In this phase 3 , double-blind trial , patients were randomly assigned ( 1:1 ) to receive enzalutamide 160 mg/day ( n=872 ) or placebo ( n=845 ) orally . HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and EQ-5D questionnaires . Pain status was assessed at screening , baseline , week 13 , and week 25 with the Brief Pain Inventory Short Form ( BPI-SF ) . The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61 . We assessed change from baseline , percentage improvement , and time to deterioration in HRQoL and pain , the proportion of patients with a skeletal-related event , and time to first skeletal-related event . Analysis was done on the intention-to-treat population . This study is registered with ClinicalTrials.gov , number NCT01212991 . FINDINGS Median treatment duration was 16·6 months ( IQR 10·1-21·1 ) in the enzalutamide group and 4·6 months ( 2·8-9·7 ) in the placebo group . The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale . Median time to deterioration in FACT-P total score was 11·3 months ( 95 % CI 11·1-13·9 ) in the enzalutamide group and 5·6 months ( 5·5-5·6 ) in the placebo groups ( hazard ratio [ HR ] 0·62 [ 95 % CI 0·54-0·72 ] ; p < 0·0001 ) . A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful improvements in FACT-P total score ( 327 [ 40 % ] of 826 vs 181 [ 23 % ] of 790 ) , in EQ-5D utility index ( 224 [ 28 % ] of 812 vs 99 [ 16 % ] of 623 ) , and visual analogue scale ( 218 [ 27 % ] of 803 vs 106 of [ 18 % ] 603 ; all p < 0·0001 ) . Median time to progression in BPI-SF pain at its worst was 5·7 months ( 95 % CI 5·6-5·7 ) in the enzalutamide group and 5·6 months ( 5·4-5·6 ) in the placebo group ( HR 0·62 [ 95 % CI 0·53-0·74 ] ; p < 0·0001 ) . Progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week 13 ( 220 [ 29 % ] of 769 vs 257 [ 42 % ] of 610 ; p < 0·0001 ) , but not at week 25 ( 225 [ 32 % ] of 705 vs 135 [ 38 % ] of 360 ; p=0·068 ) . 278 ( 32 % ) of 872 patients in the enzalutamide group and 309 ( 37 % ) of 845 patients in the placebo group had experienced a skeletal-related event by data cutoff . Median time to first skeletal-related events in the enzalutamide group was 31·1 months ( 95 % CI 29·5-not reached ) and 31·3 months ( 95 % CI 23·9-not reached ) in the placebo group ( HR 0·72 [ 95 % CI 0·61-0·84 ] ; p < 0·0001 ) . INTERPRETATION In addition to improving overall survival relative to placebo , enzalutamide significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer . FUNDING Astellas Pharma and Medivation ."
],
"offsets": [
[
0,
3762
]
]
}
] | [
{
"id": "71077",
"type": "Intervention_Pharmacological",
"text": [
"enzalutamide"
],
"offsets": [
[
10,
22
]
],
"normalized": []
},
{
"id": "71078",
"type": "Intervention_Pharmacological",
"text": [
"Enzalutamide"
],
"offsets": [
[
288,
300
]
],
"normalized": []
},
{
"id": "71079",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
399,
406
]
],
"normalized": []
},
{
"id": "71080",
"type": "Intervention_Pharmacological",
"text": [
"enzalutamide"
],
"offsets": [
[
10,
22
]
],
"normalized": []
},
{
"id": "71081",
"type": "Intervention_Pharmacological",
"text": [
"enzalutamide 160 mg/day"
],
"offsets": [
[
800,
823
]
],
"normalized": []
},
{
"id": "71082",
"type": "Intervention_Control",
"text": [
"or placebo"
],
"offsets": [
[
834,
844
]
],
"normalized": []
},
{
"id": "71083",
"type": "Outcome_Pain",
"text": [
"health-related quality of life , pain , and skeletal-related events"
],
"offsets": [
[
26,
93
]
],
"normalized": []
},
{
"id": "71084",
"type": "Outcome_Physical",
"text": [
"overall survival"
],
"offsets": [
[
325,
341
]
],
"normalized": []
},
{
"id": "71085",
"type": "Outcome_Physical",
"text": [
"radiographic progression-free survival"
],
"offsets": [
[
346,
384
]
],
"normalized": []
},
{
"id": "71086",
"type": "Outcome_Physical",
"text": [
"health-related quality of life ( HRQoL )"
],
"offsets": [
[
595,
635
]
],
"normalized": []
},
{
"id": "71087",
"type": "Outcome_Pain",
"text": [
"pain"
],
"offsets": [
[
59,
63
]
],
"normalized": []
},
{
"id": "71088",
"type": "Outcome_Physical",
"text": [
"skeletal-related events"
],
"offsets": [
[
70,
93
]
],
"normalized": []
},
{
"id": "71089",
"type": "Outcome_Physical",
"text": [
"HRQoL"
],
"offsets": [
[
628,
633
]
],
"normalized": []
},
{
"id": "71090",
"type": "Outcome_Pain",
"text": [
"Pain status"
],
"offsets": [
[
1013,
1024
]
],
"normalized": []
},
{
"id": "71091",
"type": "Outcome_Pain",
"text": [
"Brief Pain Inventory Short Form ( BPI-SF ) ."
],
"offsets": [
[
1095,
1139
]
],
"normalized": []
},
{
"id": "71092",
"type": "Outcome_Physical",
"text": [
"primary analysis of HRQoL data"
],
"offsets": [
[
1144,
1174
]
],
"normalized": []
},
{
"id": "71093",
"type": "Outcome_Physical",
"text": [
"change from baseline"
],
"offsets": [
[
1252,
1272
]
],
"normalized": []
},
{
"id": "71094",
"type": "Outcome_Physical",
"text": [
"percentage improvement"
],
"offsets": [
[
1321,
1343
]
],
"normalized": []
},
{
"id": "71095",
"type": "Outcome_Physical",
"text": [
"time to deterioration in HRQoL and pain"
],
"offsets": [
[
1350,
1389
]
],
"normalized": []
},
{
"id": "71096",
"type": "Outcome_Mental",
"text": [
"proportion of patients with a skeletal-related event"
],
"offsets": [
[
1396,
1448
]
],
"normalized": []
},
{
"id": "71097",
"type": "Outcome_Mental",
"text": [
"time to first skeletal-related event"
],
"offsets": [
[
1455,
1491
]
],
"normalized": []
},
{
"id": "71098",
"type": "Outcome_Mental",
"text": [
"Median treatment duration"
],
"offsets": [
[
1632,
1657
]
],
"normalized": []
},
{
"id": "71099",
"type": "Outcome_Mental",
"text": [
"significant treatment differences"
],
"offsets": [
[
1808,
1841
]
],
"normalized": []
},
{
"id": "71100",
"type": "Outcome_Other",
"text": [
"endpoints and EQ-5D visual analogue scale"
],
"offsets": [
[
1933,
1974
]
],
"normalized": []
},
{
"id": "71101",
"type": "Outcome_Other",
"text": [
"Median time to deterioration in FACT-P total"
],
"offsets": [
[
1977,
2021
]
],
"normalized": []
},
{
"id": "71102",
"type": "Outcome_Other",
"text": [
"improvements in FACT-P"
],
"offsets": [
[
2337,
2359
]
],
"normalized": []
},
{
"id": "71103",
"type": "Outcome_Other",
"text": [
"[ 23 % ] of 790 ) , in EQ-5D"
],
"offsets": [
[
2401,
2429
]
],
"normalized": []
},
{
"id": "71104",
"type": "Outcome_Other",
"text": [
"[ 16 % ] of 623 ) , and visual"
],
"offsets": [
[
2472,
2502
]
],
"normalized": []
},
{
"id": "71105",
"type": "Outcome_Other",
"text": [
"603 ; all p < 0·0001 )"
],
"offsets": [
[
2559,
2581
]
],
"normalized": []
},
{
"id": "71106",
"type": "Outcome_Other",
"text": [
"CI 0·53-0·74 ] ; p < 0·0001 )"
],
"offsets": [
[
2765,
2794
]
],
"normalized": []
},
{
"id": "71107",
"type": "Outcome_Other",
"text": [
"placebo group had experienced"
],
"offsets": [
[
3144,
3173
]
],
"normalized": []
},
{
"id": "71108",
"type": "Outcome_Mental",
"text": [
"skeletal-related event by data cutoff"
],
"offsets": [
[
3176,
3213
]
],
"normalized": []
},
{
"id": "71109",
"type": "Outcome_Other",
"text": [
"Median time to first"
],
"offsets": [
[
3216,
3236
]
],
"normalized": []
},
{
"id": "71110",
"type": "Outcome_Mental",
"text": [
"INTERPRETATION In addition"
],
"offsets": [
[
3447,
3473
]
],
"normalized": []
},
{
"id": "71111",
"type": "Outcome_Other",
"text": [
"enzalutamide significantly improves patient-related outcomes and delays occurrence"
],
"offsets": [
[
3526,
3608
]
],
"normalized": []
},
{
"id": "71112",
"type": "Participant_Condition",
"text": [
"asymptomatic and minimally symptomatic , chemotherapy-naive patients with metastatic castration-resistant prostate cancer ( PREVAIL"
],
"offsets": [
[
97,
228
]
],
"normalized": []
},
{
"id": "71113",
"type": "Participant_Condition",
"text": [
"asymptomatic and minimally symptomatic"
],
"offsets": [
[
97,
135
]
],
"normalized": []
},
{
"id": "71114",
"type": "Participant_Condition",
"text": [
"chemotherapy-naive patients with metastatic castration-resistant prostate cancer"
],
"offsets": [
[
138,
218
]
],
"normalized": []
},
{
"id": "71115",
"type": "Participant_Condition",
"text": [
"patients were randomly assigned ( 1:1 ) to"
],
"offsets": [
[
749,
791
]
],
"normalized": []
},
{
"id": "71116",
"type": "Participant_Condition",
"text": [
"or"
],
"offsets": [
[
561,
563
]
],
"normalized": []
},
{
"id": "71117",
"type": "Participant_Condition",
"text": [
"occurrence of first skeletal-related event in chemotherapy-naive"
],
"offsets": [
[
3598,
3662
]
],
"normalized": []
},
{
"id": "71118",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
911,
914
]
],
"normalized": []
},
{
"id": "71119",
"type": "Participant_Condition",
"text": [
"with metastatic"
],
"offsets": [
[
166,
181
]
],
"normalized": []
}
] | [] | [] | [] |
71120 | 25892145 | [
{
"id": "71121",
"type": "document",
"text": [
"Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy ( LUX-Head & Neck 1 ) : an open-label , randomised phase 3 trial . BACKGROUND Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( HNSCC ) progressing after first-line platinum regimens have a poor prognosis and few treatment options . Afatinib , an irreversible ERBB family blocker , has shown efficacy in a phase 2 study in this setting . We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy . METHODS In this open-label , phase 3 , randomised controlled trial conducted in 101 centres in 19 countries , we enrolled patients aged 18 years or older with histologically or cytologically confirmed HNSCC that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 . Previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with EGFR-targeted antibody therapy ( but not EGFR-targeted tyrosine-kinase inhibitors ) was allowed . We randomly assigned eligible patients in a 2:1 ratio to receive oral afatinib ( 40 mg/day ) or intravenous methotrexate ( 40 mg/m ( 2 ) per week ) , stratified by ECOG performance status and previous EGFR-targeted antibody therapy for recurrent or metastatic disease . Randomisation was done centrally with an interactive voice or web-based response system . Clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner . The primary endpoint was progression-free survival as assessed by an independent , central imaging review committee . Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug . This ongoing study is registered with ClinicalTrials.gov , number NCT01345682 . FINDINGS Between Jan 10 , 2012 , and Dec 12 , 2013 , we enrolled 483 patients and randomly assigned 322 to afatinib and 161 to methotrexate . After a median follow-up of 6·7 months ( IQR 3·1-9·0 ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median 2·6 months [ 95 % CI 2·0-2·7 ] for the afatinib group vs 1·7 months [ 1·5-2·4 ] for the methotrexate group ; hazard ratio [ HR ] 0·80 [ 95 % CI 0·65-0·98 ] , p=0·030 ) . The most frequent grade 3 or 4 drug-related adverse events were rash or acne ( 31 [ 10 % ] of 320 patients in the afatinib group vs none of 160 patients in the methotrexate group ) , diarrhoea ( 30 [ 9 % ] vs three [ 2 % ] ) , stomatitis ( 20 [ 6 % ] vs 13 [ 8 % ] ) , fatigue ( 18 [ 6 % ] vs five [ 3 % ] ) , and neutropenia ( 1 [ < 1 % ] vs 11 [ 7 % ] ) ; serious adverse events occurred in 44 ( 14 % ) of afatinib-treated patients and 18 ( 11 % ) of methotrexate-treated patients . INTERPRETATION Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile . These findings provide important new insights into the treatment of this patient population and support further investigations with irreversible ERBB family blockers in HNSCC . FUNDING Boehringer Ingelheim ."
],
"offsets": [
[
0,
3579
]
]
}
] | [
{
"id": "71122",
"type": "Intervention_Pharmacological",
"text": [
"Afatinib"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "71123",
"type": "Intervention_Pharmacological",
"text": [
"methotrexate"
],
"offsets": [
[
16,
28
]
],
"normalized": []
},
{
"id": "71124",
"type": "Intervention_Pharmacological",
"text": [
"Afatinib"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "71125",
"type": "Intervention_Pharmacological",
"text": [
"afatinib"
],
"offsets": [
[
606,
614
]
],
"normalized": []
},
{
"id": "71126",
"type": "Intervention_Pharmacological",
"text": [
"methotrexate"
],
"offsets": [
[
16,
28
]
],
"normalized": []
},
{
"id": "71127",
"type": "Intervention_Pharmacological",
"text": [
"EGFR-targeted antibody therapy ( but not EGFR-targeted tyrosine-kinase inhibitors"
],
"offsets": [
[
1338,
1419
]
],
"normalized": []
},
{
"id": "71128",
"type": "Intervention_Pharmacological",
"text": [
"oral afatinib ( 40 mg/day )"
],
"offsets": [
[
1501,
1528
]
],
"normalized": []
},
{
"id": "71129",
"type": "Intervention_Pharmacological",
"text": [
"intravenous methotrexate"
],
"offsets": [
[
1532,
1556
]
],
"normalized": []
},
{
"id": "71130",
"type": "Intervention_Pharmacological",
"text": [
"afatinib"
],
"offsets": [
[
606,
614
]
],
"normalized": []
},
{
"id": "71131",
"type": "Intervention_Pharmacological",
"text": [
"methotrexate ."
],
"offsets": [
[
2410,
2424
]
],
"normalized": []
},
{
"id": "71132",
"type": "Outcome_Mortality",
"text": [
"progression-free survival"
],
"offsets": [
[
1956,
1981
]
],
"normalized": []
},
{
"id": "71133",
"type": "Outcome_Other",
"text": [
"Efficacy analyses"
],
"offsets": [
[
2049,
2066
]
],
"normalized": []
},
{
"id": "71134",
"type": "Outcome_Other",
"text": [
"safety analyses"
],
"offsets": [
[
2118,
2133
]
],
"normalized": []
}
] | [] | [] | [] |
71135 | 25893544 | [
{
"id": "71136",
"type": "document",
"text": [
"Icosapent Ethyl ( Eicosapentaenoic Acid Ethyl Ester ) : Effects Upon High-Sensitivity C-Reactive Protein and Lipid Parameters in Patients With Metabolic Syndrome . BACKGROUND The aim of this analysis was to examine the effects of icosapent ethyl ( eicosapentaenoic acid ethyl ester , IPE ) on high-sensitivity C-reactive protein ( hsCRP ) and lipid parameters in patients with metabolic syndrome , with and without stable statin therapy . METHODS This post hoc exploratory analysis evaluated patients with metabolic syndrome treated with IPE 4 grams/day , IPE 2 grams/day , or placebo in phase 3 , randomized , placebo-controlled studies entitled : MARINE [ triglyceride ( TG ) levels ≥500 and ≤2000 mg/dL ] and ANCHOR [ TG levels ≥200 and < 500 mg/dL , despite low-density lipoprotein cholesterol ( LDL-C ) control with stable statin therapy ] . RESULTS Compared with placebo in patients with metabolic syndrome in MARINE ( n=204 ) and ANCHOR ( n=645 ) , at the approved dose of 4 grams/day , IPE significantly lowered hsCRP levels 40.0 % ( P=0.0007 ) in MARINE and 23.0 % ( P=0.0003 ) in ANCHOR . Compared with placebo in MARINE , which included patients with and without statin therapy , IPE 4 grams/day significantly reduced hsCRP levels 78.0 % in statin-treated patients ( P=0.0035 , n=16 ) . Compared with placebo in MARINE , IPE 4 grams/day significantly reduced TG levels ( 35.0 % ; P < 0.0001 ) , non-high-density lipoprotein cholesterol ( non-HDL-C ; 19.9 % ; P < 0.0001 ) , and apolipoprotein B levels ( ApoB ) ( 9.1 % ; P=0.0015 ) without raising LDL-C levels . Compared with placebo in ANCHOR , IPE 4 grams/day significantly reduced TG ( 21.7 % ; P < 0.0001 ) , non-HDL-C ( 13.5 % ; P < 0.0001 ) , ApoB ( 8.8 % ; P < 0.0001 ) , LDL-C ( 5.2 % ; P=0.0236 ) , and HDL-C levels ( 4.0 % ; P=0.0053 ) . CONCLUSIONS Compared with placebo , IPE 4 grams/day significantly lowered hsCRP levels and improved lipids without raising LDL-C levels in patients with metabolic syndrome and high ( ≥200 and < 500 mg/dL ) or very high ( ≥500 and ≤2000 mg/dL ) TG levels , with or without stable statin therapy ."
],
"offsets": [
[
0,
2105
]
]
}
] | [
{
"id": "71137",
"type": "Intervention_Pharmacological",
"text": [
"Icosapent Ethyl ( Eicosapentaenoic Acid Ethyl Ester )"
],
"offsets": [
[
0,
53
]
],
"normalized": []
},
{
"id": "71138",
"type": "Intervention_Pharmacological",
"text": [
"icosapent ethyl ( eicosapentaenoic acid ethyl ester , IPE )"
],
"offsets": [
[
230,
289
]
],
"normalized": []
},
{
"id": "71139",
"type": "Intervention_Pharmacological",
"text": [
"IPE"
],
"offsets": [
[
284,
287
]
],
"normalized": []
},
{
"id": "71140",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
577,
584
]
],
"normalized": []
},
{
"id": "71141",
"type": "Outcome_Physical",
"text": [
"significantly lowered hsCRP"
],
"offsets": [
[
998,
1025
]
],
"normalized": []
},
{
"id": "71142",
"type": "Outcome_Physical",
"text": [
"significantly reduced hsCRP"
],
"offsets": [
[
1207,
1234
]
],
"normalized": []
},
{
"id": "71143",
"type": "Outcome_Physical",
"text": [
"non-high-density lipoprotein cholesterol ( non-HDL-C"
],
"offsets": [
[
1406,
1458
]
],
"normalized": []
},
{
"id": "71144",
"type": "Outcome_Physical",
"text": [
"apolipoprotein"
],
"offsets": [
[
1489,
1503
]
],
"normalized": []
},
{
"id": "71145",
"type": "Outcome_Physical",
"text": [
"raising LDL-C"
],
"offsets": [
[
1551,
1564
]
],
"normalized": []
},
{
"id": "71146",
"type": "Participant_Condition",
"text": [
"Patients With Metabolic Syndrome"
],
"offsets": [
[
129,
161
]
],
"normalized": []
},
{
"id": "71147",
"type": "Participant_Condition",
"text": [
"patients with metabolic syndrome , with and without stable statin therapy"
],
"offsets": [
[
363,
436
]
],
"normalized": []
},
{
"id": "71148",
"type": "Participant_Condition",
"text": [
"metabolic syndrome treated with IPE 4 grams/day"
],
"offsets": [
[
506,
553
]
],
"normalized": []
},
{
"id": "71149",
"type": "Participant_Condition",
"text": [
"metabolic syndrome"
],
"offsets": [
[
377,
395
]
],
"normalized": []
},
{
"id": "71150",
"type": "Participant_Sample-size",
"text": [
"n=204"
],
"offsets": [
[
925,
930
]
],
"normalized": []
},
{
"id": "71151",
"type": "Participant_Condition",
"text": [
"metabolic syndrome"
],
"offsets": [
[
377,
395
]
],
"normalized": []
}
] | [] | [] | [] |
71152 | 25898050 | [
{
"id": "71153",
"type": "document",
"text": [
"Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder : a randomized clinical trial . IMPORTANCE Disruptive behavior is common in children with autism spectrum disorder . Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials . OBJECTIVE To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior . DESIGN , SETTING , AND PARTICIPANTS This 24-week randomized trial compared parent training ( n = 89 ) to parent education ( n = 91 ) at 6 centers ( Emory University , Indiana University , Ohio State University , University of Pittsburgh , University of Rochester , Yale University ) . We screened 267 children ; 180 children ( aged 3-7 years ) with autism spectrum disorder and disruptive behaviors were randomly assigned ( 86 % white , 88 % male ) between September 2010 and February 2014 . INTERVENTIONS Parent training ( 11 core , 2 optional sessions ; 2 telephone boosters ; 2 home visits ) provided specific strategies to manage disruptive behavior . Parent education ( 12 core sessions , 1 home visit ) provided information about autism but no behavior management strategies . MAIN OUTCOMES AND MEASURES Parents rated disruptive behavior and noncompliance on co-primary outcomes : the Aberrant Behavior Checklist-Irritability subscale ( range , 0-45 ) and the Home Situations Questionnaire-Autism Spectrum Disorder ( range , 0-9 ) . On both measures , higher scores indicate greater severity and a 25 % reduction indicates clinical improvement . A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression ( range , 1-7 ) , a secondary outcome , with a positive response less than 3 . RESULTS At week 24 , the Aberrant Behavior Checklist-Irritability subscale declined 47.7 % in parent training ( from 23.7 to 12.4 ) compared with 31.8 % for parent education ( 23.9 to 16.3 ) ( treatment effect , -3.9 ; 95 % CI , -6.2 to -1.7 ; P < .001 , standardized effect size = 0.62 ) . The Home Situations Questionnaire-Autism Spectrum Disorder declined 55 % ( from 4.0 to 1.8 ) compared with 34.2 % in parent education ( 3.8 to 2.5 ) ( treatment effect , -0.7 ; 95 % CI , -1.1 to -0.3 ; P < .001 , standardized effect size = 0.45 ) . Neither measure met the prespecified minimal clinically important difference . The proportions with a positive response on the Clinical Global Impression-Improvement scale were 68.5 % for parent training vs 39.6 % for parent education ( P < .001 ) . CONCLUSIONS AND RELEVANCE For children with autism spectrum disorder , a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear . The rate of positive response judged by a blinded clinician was greater for parent training vs parent education . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01233414 ."
],
"offsets": [
[
0,
3048
]
]
}
] | [
{
"id": "71154",
"type": "Intervention_Educational",
"text": [
"parent training"
],
"offsets": [
[
10,
25
]
],
"normalized": []
},
{
"id": "71155",
"type": "Intervention_Educational",
"text": [
"parent education"
],
"offsets": [
[
29,
45
]
],
"normalized": []
},
{
"id": "71156",
"type": "Intervention_Educational",
"text": [
"parent training"
],
"offsets": [
[
10,
25
]
],
"normalized": []
},
{
"id": "71157",
"type": "Participant_Condition",
"text": [
"behavioral problems"
],
"offsets": [
[
49,
68
]
],
"normalized": []
},
{
"id": "71158",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
72,
80
]
],
"normalized": []
},
{
"id": "71159",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder"
],
"offsets": [
[
86,
110
]
],
"normalized": []
},
{
"id": "71160",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
72,
80
]
],
"normalized": []
},
{
"id": "71161",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder"
],
"offsets": [
[
86,
110
]
],
"normalized": []
},
{
"id": "71162",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder"
],
"offsets": [
[
86,
110
]
],
"normalized": []
},
{
"id": "71163",
"type": "Participant_Condition",
"text": [
"disruptive behavior"
],
"offsets": [
[
271,
290
]
],
"normalized": []
},
{
"id": "71164",
"type": "Participant_Age",
"text": [
"parent"
],
"offsets": [
[
10,
16
]
],
"normalized": []
},
{
"id": "71165",
"type": "Participant_Sample-size",
"text": [
"n = 89 )"
],
"offsets": [
[
570,
578
]
],
"normalized": []
},
{
"id": "71166",
"type": "Participant_Age",
"text": [
"parent"
],
"offsets": [
[
10,
16
]
],
"normalized": []
},
{
"id": "71167",
"type": "Participant_Sample-size",
"text": [
"education ( n = 91"
],
"offsets": [
[
589,
607
]
],
"normalized": []
},
{
"id": "71168",
"type": "Participant_Sample-size",
"text": [
"267 children"
],
"offsets": [
[
774,
786
]
],
"normalized": []
},
{
"id": "71169",
"type": "Participant_Sample-size",
"text": [
"180 children"
],
"offsets": [
[
789,
801
]
],
"normalized": []
},
{
"id": "71170",
"type": "Participant_Age",
"text": [
"aged 3-7 years"
],
"offsets": [
[
804,
818
]
],
"normalized": []
},
{
"id": "71171",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder"
],
"offsets": [
[
86,
110
]
],
"normalized": []
},
{
"id": "71172",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
72,
80
]
],
"normalized": []
}
] | [] | [] | [] |
71173 | 2590611 | [
{
"id": "71174",
"type": "document",
"text": [
"Differential effect of aspirin on thromboxane and prostaglandin biosynthesis in man . 1 . Effects of a single intravenous dose of aspirin ( 600 mg ) on bradykinin-stimulated prostaglandin ( PG ) and on thromboxane ( TX ) biosynthesis were determined in nine healthy male volunteers . Plasma concentrations of 6-oxo-PGF1 alpha and 13,14-dihydro-15-oxo-PGF2 alpha were measured in samples obtained during repeated 10 min intravenous infusions of bradykinin before and up to 6 h after the dose of aspirin . TXB2 was measured in serum from blood allowed to clot at 37 degrees C. 2 . Aspirin inhibited bradykinin stimulated PG and platelet TX biosynthesis 0.5 h after the dose . Serum TXB2 remained low , whereas PG synthesis recovered within 6 h. 3 . Effects of intravenous sodium salicylate ( 600 mg ) were studied identically in eight subjects . Prostanoid biosynthesis was not inhibited . 4 . Biosynthesis of prostacyclin and TXA2 under basal conditions was studied in eight subjects by measuring 2,3-dinor-6-oxo-PGF1 alpha and 2,3-dinor-TXB2 in hourly urine samples obtained during and after intravenous infusion of aspirin and , on a separate occasion , of vehicle . 5 . Aspirin infusion reduced urinary excretion of both metabolites greater than 90 % , but excretion of 2,3-dinor-6-oxo-PGF1 alpha recovered more rapidly than did that of 2,3-dinor-TXB2 . 6 . We conclude that cyclo-oxygenase is rapidly synthesised in bradykinin-responsive tissues in vivo and that this reflects similarly rapid enzyme biosynthesis in tissues that produce PGI2 under basal conditions ."
],
"offsets": [
[
0,
1569
]
]
}
] | [
{
"id": "71175",
"type": "Intervention_Pharmacological",
"text": [
"aspirin"
],
"offsets": [
[
23,
30
]
],
"normalized": []
},
{
"id": "71176",
"type": "Intervention_Pharmacological",
"text": [
"aspirin"
],
"offsets": [
[
23,
30
]
],
"normalized": []
},
{
"id": "71177",
"type": "Intervention_Pharmacological",
"text": [
"aspirin"
],
"offsets": [
[
23,
30
]
],
"normalized": []
},
{
"id": "71178",
"type": "Intervention_Pharmacological",
"text": [
"Aspirin"
],
"offsets": [
[
579,
586
]
],
"normalized": []
},
{
"id": "71179",
"type": "Intervention_Pharmacological",
"text": [
"intravenous sodium salicylate"
],
"offsets": [
[
758,
787
]
],
"normalized": []
},
{
"id": "71180",
"type": "Intervention_Pharmacological",
"text": [
"infusion of aspirin"
],
"offsets": [
[
1104,
1123
]
],
"normalized": []
},
{
"id": "71181",
"type": "Intervention_Pharmacological",
"text": [
"Aspirin infusion"
],
"offsets": [
[
1172,
1188
]
],
"normalized": []
},
{
"id": "71182",
"type": "Outcome_Physical",
"text": [
"thromboxane and prostaglandin biosynthesis"
],
"offsets": [
[
34,
76
]
],
"normalized": []
},
{
"id": "71183",
"type": "Outcome_Physical",
"text": [
"bradykinin-stimulated prostaglandin ( PG ) and on thromboxane ( TX ) biosynthesis"
],
"offsets": [
[
152,
233
]
],
"normalized": []
},
{
"id": "71184",
"type": "Outcome_Physical",
"text": [
"TXB2 was measured in serum"
],
"offsets": [
[
504,
530
]
],
"normalized": []
},
{
"id": "71185",
"type": "Outcome_Physical",
"text": [
"Aspirin inhibited bradykinin stimulated PG"
],
"offsets": [
[
579,
621
]
],
"normalized": []
},
{
"id": "71186",
"type": "Outcome_Physical",
"text": [
"Serum TXB2 remained low"
],
"offsets": [
[
674,
697
]
],
"normalized": []
},
{
"id": "71187",
"type": "Outcome_Physical",
"text": [
"PG synthesis recovered"
],
"offsets": [
[
708,
730
]
],
"normalized": []
},
{
"id": "71188",
"type": "Outcome_Physical",
"text": [
"Prostanoid biosynthesis"
],
"offsets": [
[
844,
867
]
],
"normalized": []
},
{
"id": "71189",
"type": "Outcome_Physical",
"text": [
"Biosynthesis of prostacyclin and TXA2"
],
"offsets": [
[
892,
929
]
],
"normalized": []
},
{
"id": "71190",
"type": "Outcome_Physical",
"text": [
"2,3-dinor-6-oxo-PGF1 alpha"
],
"offsets": [
[
996,
1022
]
],
"normalized": []
},
{
"id": "71191",
"type": "Outcome_Physical",
"text": [
"2,3-dinor-TXB2"
],
"offsets": [
[
1027,
1041
]
],
"normalized": []
},
{
"id": "71192",
"type": "Outcome_Physical",
"text": [
"urinary excretion"
],
"offsets": [
[
1197,
1214
]
],
"normalized": []
},
{
"id": "71193",
"type": "Outcome_Physical",
"text": [
"2,3-dinor-6-oxo-PGF1 alpha recovered more rapidly"
],
"offsets": [
[
1272,
1321
]
],
"normalized": []
},
{
"id": "71194",
"type": "Outcome_Physical",
"text": [
"rapidly synthesised in bradykinin-responsive tissues"
],
"offsets": [
[
1396,
1448
]
],
"normalized": []
},
{
"id": "71195",
"type": "Participant_Condition",
"text": [
"thromboxane and prostaglandin biosynthesis"
],
"offsets": [
[
34,
76
]
],
"normalized": []
},
{
"id": "71196",
"type": "Participant_Sex",
"text": [
"man"
],
"offsets": [
[
80,
83
]
],
"normalized": []
},
{
"id": "71197",
"type": "Participant_Sample-size",
"text": [
"nine"
],
"offsets": [
[
253,
257
]
],
"normalized": []
},
{
"id": "71198",
"type": "Participant_Condition",
"text": [
"healthy"
],
"offsets": [
[
258,
265
]
],
"normalized": []
},
{
"id": "71199",
"type": "Participant_Sex",
"text": [
"male"
],
"offsets": [
[
266,
270
]
],
"normalized": []
}
] | [] | [] | [] |
71200 | 25907208 | [
{
"id": "71201",
"type": "document",
"text": [
"Effect of cooling proparacaine 0.5 % eye drops on patient 's comfort during instillation ."
],
"offsets": [
[
0,
90
]
]
}
] | [
{
"id": "71202",
"type": "Intervention_Pharmacological",
"text": [
"proparacaine 0.5 % eye drops"
],
"offsets": [
[
18,
46
]
],
"normalized": []
},
{
"id": "71203",
"type": "Outcome_Physical",
"text": [
"Effect of cooling"
],
"offsets": [
[
0,
17
]
],
"normalized": []
},
{
"id": "71204",
"type": "Outcome_Mental",
"text": [
"patient 's comfort"
],
"offsets": [
[
50,
68
]
],
"normalized": []
},
{
"id": "71205",
"type": "Participant_Condition",
"text": [
"0.5 % eye drops on patient 's comfort during instillation"
],
"offsets": [
[
31,
88
]
],
"normalized": []
}
] | [] | [] | [] |
71206 | 25910710 | [
{
"id": "71207",
"type": "document",
"text": [
"Investigating a Multimodal Intervention for Children With Limited Expressive Vocabularies Associated With Autism . PURPOSE This study investigated a new intervention package aimed at increasing expressive word learning by school-age children with autism who have limited expressive vocabularies . This pilot investigation was intended to show proof of concept . METHOD Ten children between the ages of 6 and 10 years participated , with educational diagnoses of autism and limited expressive vocabularies at the outset of the study . A multimodal intervention composed of speech sound practice and augmentative and alternative communication was used to teach individualized vocabulary words that were selected on the basis of initial speech sound repertoires and principles of phonotactic probability and neighborhood density . A multiple-probe design was used to evaluate learning outcomes . RESULTS Five children showed gains in spoken-word learning across successive word sets ( high responders ) . Five children did not meet learning criteria ( low responders ) . Comparisons of behaviors measured prior to intervention indicated that high responders had relatively higher skills in receptive language , prelinguistic communication , vocal/verbal imitation , adaptive behavior , and consonant productions . CONCLUSIONS The intervention package holds promise for improving spoken word productions for some children with autism who have limited expressive vocabularies . Further research is needed to better describe who may most benefit from this approach as well as investigate generalized benefits to untaught contexts and targets ."
],
"offsets": [
[
0,
1637
]
]
}
] | [
{
"id": "71208",
"type": "Intervention_Educational",
"text": [
"Multimodal Intervention"
],
"offsets": [
[
16,
39
]
],
"normalized": []
},
{
"id": "71209",
"type": "Intervention_Educational",
"text": [
"multimodal intervention"
],
"offsets": [
[
536,
559
]
],
"normalized": []
},
{
"id": "71210",
"type": "Intervention_Educational",
"text": [
"speech sound practice"
],
"offsets": [
[
572,
593
]
],
"normalized": []
},
{
"id": "71211",
"type": "Intervention_Educational",
"text": [
"augmentative and alternative communication"
],
"offsets": [
[
598,
640
]
],
"normalized": []
},
{
"id": "71212",
"type": "Intervention_Educational",
"text": [
"intervention package"
],
"offsets": [
[
153,
173
]
],
"normalized": []
},
{
"id": "71213",
"type": "Outcome_Mental",
"text": [
"spoken-word learning across successive word sets"
],
"offsets": [
[
931,
979
]
],
"normalized": []
},
{
"id": "71214",
"type": "Outcome_Mental",
"text": [
"receptive language , prelinguistic communication , vocal/verbal imitation , adaptive behavior , and consonant productions ."
],
"offsets": [
[
1187,
1310
]
],
"normalized": []
},
{
"id": "71215",
"type": "Participant_Age",
"text": [
"Children"
],
"offsets": [
[
44,
52
]
],
"normalized": []
},
{
"id": "71216",
"type": "Participant_Condition",
"text": [
"Limited Expressive Vocabularies"
],
"offsets": [
[
58,
89
]
],
"normalized": []
},
{
"id": "71217",
"type": "Participant_Condition",
"text": [
"Autism"
],
"offsets": [
[
106,
112
]
],
"normalized": []
},
{
"id": "71218",
"type": "Participant_Age",
"text": [
"school-age children"
],
"offsets": [
[
222,
241
]
],
"normalized": []
},
{
"id": "71219",
"type": "Participant_Sample-size",
"text": [
"Ten"
],
"offsets": [
[
369,
372
]
],
"normalized": []
},
{
"id": "71220",
"type": "Participant_Age",
"text": [
"children between the ages of 6 and 10 years"
],
"offsets": [
[
373,
416
]
],
"normalized": []
},
{
"id": "71221",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
247,
253
]
],
"normalized": []
},
{
"id": "71222",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
233,
241
]
],
"normalized": []
},
{
"id": "71223",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
233,
241
]
],
"normalized": []
},
{
"id": "71224",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
233,
241
]
],
"normalized": []
},
{
"id": "71225",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
247,
253
]
],
"normalized": []
}
] | [] | [] | [] |
71226 | 25912520 | [
{
"id": "71227",
"type": "document",
"text": [
"Effects of the Quest to Lava Mountain Computer Game on Dietary and Physical Activity Behaviors of Elementary School Children : A Pilot Group-Randomized Controlled Trial . BACKGROUND Computer-based educational games present an opportunity for health education in school ; however , their feasibility in school settings and effectiveness in changing behavior are poorly understood . OBJECTIVE To evaluate the feasibility , acceptability , and effects of the Quest to Lava Mountain ( QTLM ) computer game on dietary behaviors , physical activity behaviors , and psychosocial factors among ethnically diverse children in Texas . DESIGN Quasi-experimental group-randomized controlled trial conducted during the 2012-2013 school year . PARTICIPANTS/SETTING A total of 107 children in fourth and fifth grade consented . There was an attrition rate of 8.8 % with a final sample size of 44 children in three intervention schools , and a sample of 50 children in three comparison schools . Dietary intake was measured using two random 24-hour recalls , whereas child self-report surveys measured diet , physical activity , and psychosocial factors before and after the intervention . Process data on QTLM usability and back-end server data on QTLM exposure and progress achieved were collected . INTERVENTION QTLM was implemented as part of the in-school or afterschool program . Recommended game exposure duration was 90 min/wk for 6 weeks . STATISTICAL ANALYSIS Analysis of covariance or logistic regression models evaluated effects of QTLM on diet , physical activity , and psychosocial factors . Post hoc exploratory analysis examined the changes before and after the intervention in outcome variables among children in the intervention group . Significance was set at P < 0.05 . RESULTS Children played an average of 274±110 minutes ( approximately 4.6 hours ) of QTLM during the 6 weeks ( 51 % of recommended dosage ) . Compared with the comparison group , children in the intervention group reported decreased sugar consumption ( P=0.021 ) and higher nutrition/physical activity attitudes ( P=0.041 ) pre- to postintervention . There were no significant effects of QTLM on physical activity . However , post hoc analysis showed that higher QTLM exposure and gaming progress was associated with increased frequency of physical activity ( P < 0.05 ) . CONCLUSIONS QTLM has some promising acceptability and initial effects on diet and physical activity behaviors among children in elementary school ."
],
"offsets": [
[
0,
2494
]
]
}
] | [
{
"id": "71228",
"type": "Intervention_Educational",
"text": [
"Quest to Lava Mountain Computer Game"
],
"offsets": [
[
15,
51
]
],
"normalized": []
},
{
"id": "71229",
"type": "Intervention_Educational",
"text": [
"Computer-based educational games"
],
"offsets": [
[
182,
214
]
],
"normalized": []
},
{
"id": "71230",
"type": "Intervention_Educational",
"text": [
"Quest to Lava Mountain ( QTLM ) computer game"
],
"offsets": [
[
456,
501
]
],
"normalized": []
},
{
"id": "71231",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71232",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71233",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71234",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71235",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71236",
"type": "Intervention_Educational",
"text": [
"QTLM"
],
"offsets": [
[
481,
485
]
],
"normalized": []
},
{
"id": "71237",
"type": "Outcome_Physical",
"text": [
"Dietary and Physical Activity Behaviors"
],
"offsets": [
[
55,
94
]
],
"normalized": []
},
{
"id": "71238",
"type": "Outcome_Mental",
"text": [
"dietary behaviors"
],
"offsets": [
[
505,
522
]
],
"normalized": []
},
{
"id": "71239",
"type": "Outcome_Mental",
"text": [
"physical activity behaviors"
],
"offsets": [
[
525,
552
]
],
"normalized": []
},
{
"id": "71240",
"type": "Outcome_Mental",
"text": [
"psychosocial factors"
],
"offsets": [
[
559,
579
]
],
"normalized": []
},
{
"id": "71241",
"type": "Outcome_Mental",
"text": [
"diet"
],
"offsets": [
[
505,
509
]
],
"normalized": []
},
{
"id": "71242",
"type": "Outcome_Mental",
"text": [
"physical activity"
],
"offsets": [
[
525,
542
]
],
"normalized": []
},
{
"id": "71243",
"type": "Outcome_Mental",
"text": [
"psychosocial factors"
],
"offsets": [
[
559,
579
]
],
"normalized": []
},
{
"id": "71244",
"type": "Outcome_Mental",
"text": [
"diet"
],
"offsets": [
[
505,
509
]
],
"normalized": []
},
{
"id": "71245",
"type": "Outcome_Mental",
"text": [
"physical activity"
],
"offsets": [
[
525,
542
]
],
"normalized": []
},
{
"id": "71246",
"type": "Outcome_Mental",
"text": [
"psychosocial factors"
],
"offsets": [
[
559,
579
]
],
"normalized": []
},
{
"id": "71247",
"type": "Outcome_Mental",
"text": [
"sugar consumption"
],
"offsets": [
[
2007,
2024
]
],
"normalized": []
},
{
"id": "71248",
"type": "Outcome_Mental",
"text": [
"nutrition/physical activity attitudes"
],
"offsets": [
[
2048,
2085
]
],
"normalized": []
},
{
"id": "71249",
"type": "Outcome_Mental",
"text": [
"physical activity"
],
"offsets": [
[
525,
542
]
],
"normalized": []
},
{
"id": "71250",
"type": "Outcome_Physical",
"text": [
"increased frequency of physical activity"
],
"offsets": [
[
2291,
2331
]
],
"normalized": []
},
{
"id": "71251",
"type": "Outcome_Mental",
"text": [
"diet"
],
"offsets": [
[
505,
509
]
],
"normalized": []
},
{
"id": "71252",
"type": "Outcome_Mental",
"text": [
"physical activity behaviors"
],
"offsets": [
[
525,
552
]
],
"normalized": []
},
{
"id": "71253",
"type": "Participant_Age",
"text": [
"Children"
],
"offsets": [
[
116,
124
]
],
"normalized": []
},
{
"id": "71254",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
605,
613
]
],
"normalized": []
},
{
"id": "71255",
"type": "Participant_Sample-size",
"text": [
"107"
],
"offsets": [
[
762,
765
]
],
"normalized": []
},
{
"id": "71256",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
605,
613
]
],
"normalized": []
},
{
"id": "71257",
"type": "Participant_Sample-size",
"text": [
"44"
],
"offsets": [
[
878,
880
]
],
"normalized": []
},
{
"id": "71258",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
605,
613
]
],
"normalized": []
},
{
"id": "71259",
"type": "Participant_Sample-size",
"text": [
"50"
],
"offsets": [
[
938,
940
]
],
"normalized": []
},
{
"id": "71260",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
605,
613
]
],
"normalized": []
}
] | [] | [] | [] |
71261 | 25912590 | [
{
"id": "71262",
"type": "document",
"text": [
"Peritonsillar infiltration with levobupivacaine for posttonsillectomy pain relief : does concentration have any effect ? A double-blind randomized controlled clinical study . OBJECTIVE Post-tonsillectomy pain is believed to be mediated by noxious stimulation of C-fiber afferents located in the peritonsillary space , and local anesthetic infiltration to this area may decrease pain by blocking the sensory pathways and thus preventing the nociceptive impulses . We aimed to compare the effects of different concentrations of preincisional peritonsillar levobupivacaine ( 0.25 % and 0.5 % ) infiltration on postoperative pain and bleeding in a placebo-controlled design . PATIENTS AND METHODS After obtaining Institutional Ethics Committee approval , 72 ASA I-II patients between 3 and 12 years of age , scheduled to undergo tonsillectomy were enrolled and randomly assigned to one of the three groups using the sealed envelope technique , as Group I ( Control group ) , Group II , and Group III receiving preincisional bilateral peritonsillar infiltration with saline , 0.25 % levobupivacaine and 0.5 % levobupivacaine , respectively ( 3 mL to each tonsil ) . Pain , fever , dysphagia ; nausea-vomiting and hemorrhage were evaluated at postoperative 0 , 30 , and 60 minutes and 2 , 6 , 12 , and 24 hours . Oral paracetamol was administered at a dose of 15 mg/kg when FLACC score was > 4 . The number of paracetamol administrations within the first 24 hours were recorded . RESULTS The patients in Groups I , II and III defined pain ( FLACC > 4 ) at a rate of 87 % , 60.9 % , and 54.2 % within the postoperative first 24 hours , respectively . The total number of additional analgesic requirements was significantly low in Group II and III when compared with Group I . There was no difference between groups in terms of fever , dysphagia , nausea-vomiting , hemorrhage . CONCLUSIONS Both concentrations ( 0.50 % and 0.25 % ) of levobupivacaine were found to be equally safe and effective during preincisional peritonsillar infiltration in children . NCT number : 02322346 ."
],
"offsets": [
[
0,
2073
]
]
}
] | [
{
"id": "71263",
"type": "Intervention_Pharmacological",
"text": [
"levobupivacaine"
],
"offsets": [
[
32,
47
]
],
"normalized": []
},
{
"id": "71264",
"type": "Intervention_Pharmacological",
"text": [
"peritonsillar levobupivacaine"
],
"offsets": [
[
540,
569
]
],
"normalized": []
},
{
"id": "71265",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
644,
662
]
],
"normalized": []
},
{
"id": "71266",
"type": "Intervention_Control",
"text": [
"Control group"
],
"offsets": [
[
953,
966
]
],
"normalized": []
},
{
"id": "71267",
"type": "Intervention_Pharmacological",
"text": [
"preincisional bilateral peritonsillar infiltration with saline"
],
"offsets": [
[
1006,
1068
]
],
"normalized": []
},
{
"id": "71268",
"type": "Intervention_Pharmacological",
"text": [
"0.25 % levobupivacaine"
],
"offsets": [
[
1071,
1093
]
],
"normalized": []
},
{
"id": "71269",
"type": "Intervention_Pharmacological",
"text": [
"0.5 % levobupivacaine"
],
"offsets": [
[
1098,
1119
]
],
"normalized": []
},
{
"id": "71270",
"type": "Intervention_Pharmacological",
"text": [
"Oral paracetamol"
],
"offsets": [
[
1307,
1323
]
],
"normalized": []
},
{
"id": "71271",
"type": "Intervention_Pharmacological",
"text": [
"paracetamol"
],
"offsets": [
[
1312,
1323
]
],
"normalized": []
},
{
"id": "71272",
"type": "Intervention_Pharmacological",
"text": [
"analgesic"
],
"offsets": [
[
1675,
1684
]
],
"normalized": []
},
{
"id": "71273",
"type": "Intervention_Pharmacological",
"text": [
"levobupivacaine"
],
"offsets": [
[
32,
47
]
],
"normalized": []
},
{
"id": "71274",
"type": "Outcome_Pain",
"text": [
"pain relief :"
],
"offsets": [
[
70,
83
]
],
"normalized": []
},
{
"id": "71275",
"type": "Outcome_Pain",
"text": [
"postoperative pain and bleeding"
],
"offsets": [
[
607,
638
]
],
"normalized": []
},
{
"id": "71276",
"type": "Outcome_Pain",
"text": [
"Pain"
],
"offsets": [
[
1161,
1165
]
],
"normalized": []
},
{
"id": "71277",
"type": "Outcome_Physical",
"text": [
"fever"
],
"offsets": [
[
1168,
1173
]
],
"normalized": []
},
{
"id": "71278",
"type": "Outcome_Physical",
"text": [
"dysphagia"
],
"offsets": [
[
1176,
1185
]
],
"normalized": []
},
{
"id": "71279",
"type": "Outcome_Physical",
"text": [
"nausea-vomiting"
],
"offsets": [
[
1188,
1203
]
],
"normalized": []
},
{
"id": "71280",
"type": "Outcome_Other",
"text": [
"number of paracetamol administrations"
],
"offsets": [
[
1394,
1431
]
],
"normalized": []
},
{
"id": "71281",
"type": "Outcome_Pain",
"text": [
"pain"
],
"offsets": [
[
70,
74
]
],
"normalized": []
},
{
"id": "71282",
"type": "Outcome_Other",
"text": [
"additional analgesic requirements"
],
"offsets": [
[
1664,
1697
]
],
"normalized": []
},
{
"id": "71283",
"type": "Outcome_Physical",
"text": [
"fever"
],
"offsets": [
[
1168,
1173
]
],
"normalized": []
},
{
"id": "71284",
"type": "Outcome_Physical",
"text": [
"dysphagia"
],
"offsets": [
[
1176,
1185
]
],
"normalized": []
},
{
"id": "71285",
"type": "Outcome_Physical",
"text": [
"nausea-vomiting"
],
"offsets": [
[
1188,
1203
]
],
"normalized": []
},
{
"id": "71286",
"type": "Outcome_Physical",
"text": [
"hemorrhage"
],
"offsets": [
[
1208,
1218
]
],
"normalized": []
},
{
"id": "71287",
"type": "Outcome_Other",
"text": [
"safe and effective"
],
"offsets": [
[
1969,
1987
]
],
"normalized": []
},
{
"id": "71288",
"type": "Participant_Condition",
"text": [
"posttonsillectomy pain"
],
"offsets": [
[
52,
74
]
],
"normalized": []
},
{
"id": "71289",
"type": "Participant_Condition",
"text": [
"Post-tonsillectomy pain"
],
"offsets": [
[
185,
208
]
],
"normalized": []
},
{
"id": "71290",
"type": "Participant_Sample-size",
"text": [
"72"
],
"offsets": [
[
751,
753
]
],
"normalized": []
},
{
"id": "71291",
"type": "Participant_Age",
"text": [
"between 3 and 12 years of age"
],
"offsets": [
[
772,
801
]
],
"normalized": []
},
{
"id": "71292",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
2039,
2047
]
],
"normalized": []
}
] | [] | [] | [] |
71293 | 25915138 | [
{
"id": "71294",
"type": "document",
"text": [
"Indicators for Cervical Length in Twin Pregnancies . OBJECTIVE Cervical length ( CL ) is associated with the risk of preterm birth ( PTB ) in multiple pregnancies . However , the position of CL within the pathophysiological pathway of PTB is unclear , and it is unknown which factors are predictive for CL . This study aims to investigate whether in twin pregnancies baseline maternal and obstetrical characteristics are potential indicators for CL , to improve insight in the pathophysiological pathway of PTB . STUDY DESIGN Secondary analysis of data on twin pregnancies and CL measurement between 16 and 22 weeks . A set of 10 potential indicators , known to be associated with an increased risk of PTB and/or which have a plausible mechanism resulting in a change of CL were selected . We used multivariable linear regression with backward selection to identify independent indicators for CL . RESULTS A total of 1,447 women with twin pregnancies were included . Mean CL was 43.7 ( ±8.9 ) mm . In multivariable analysis , age ( 0.27 mm/y ; 95 % confidence interval [ CI ] 0.16 to 0.39 ) , use of assisted reproductive technologies ( ART ) ( -1.42 mm , 95 % CI -2.6 to -0.25 ) , and having delivered at term in a previous pregnancy ( 1.32 mm , 95 % CI 0.25 to 2.39 ) were significantly associated with CL . CONCLUSION This study shows that in twin pregnancies , age , use of ART and having delivered term in a previous pregnancy has an association with CL ."
],
"offsets": [
[
0,
1460
]
]
}
] | [
{
"id": "71295",
"type": "Intervention_Physical",
"text": [
"CL measurement"
],
"offsets": [
[
577,
591
]
],
"normalized": []
},
{
"id": "71296",
"type": "Outcome_Physical",
"text": [
"Cervical length ( CL )"
],
"offsets": [
[
63,
85
]
],
"normalized": []
},
{
"id": "71297",
"type": "Outcome_Physical",
"text": [
"CL ."
],
"offsets": [
[
303,
307
]
],
"normalized": []
},
{
"id": "71298",
"type": "Outcome_Physical",
"text": [
"CL"
],
"offsets": [
[
81,
83
]
],
"normalized": []
},
{
"id": "71299",
"type": "Outcome_Physical",
"text": [
"analysis of data on twin pregnancies"
],
"offsets": [
[
536,
572
]
],
"normalized": []
},
{
"id": "71300",
"type": "Outcome_Physical",
"text": [
"CL measurement"
],
"offsets": [
[
577,
591
]
],
"normalized": []
},
{
"id": "71301",
"type": "Outcome_Physical",
"text": [
"a change of CL"
],
"offsets": [
[
759,
773
]
],
"normalized": []
},
{
"id": "71302",
"type": "Outcome_Physical",
"text": [
"indicators for CL ."
],
"offsets": [
[
878,
897
]
],
"normalized": []
},
{
"id": "71303",
"type": "Outcome_Physical",
"text": [
"Mean CL"
],
"offsets": [
[
967,
974
]
],
"normalized": []
},
{
"id": "71304",
"type": "Participant_Condition",
"text": [
"twin pregnancies"
],
"offsets": [
[
350,
366
]
],
"normalized": []
},
{
"id": "71305",
"type": "Participant_Sample-size",
"text": [
"1,447"
],
"offsets": [
[
917,
922
]
],
"normalized": []
},
{
"id": "71306",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
923,
928
]
],
"normalized": []
},
{
"id": "71307",
"type": "Participant_Condition",
"text": [
"twin pregnancies"
],
"offsets": [
[
350,
366
]
],
"normalized": []
},
{
"id": "71308",
"type": "Participant_Condition",
"text": [
"that in twin pregnancies"
],
"offsets": [
[
1338,
1362
]
],
"normalized": []
}
] | [] | [] | [] |
71309 | 25919773 | [
{
"id": "71310",
"type": "document",
"text": [
"The impact of amalgam dental fillings on the frequency of Helicobacter pylori infection and H. pylori eradication rates in patients treated with concomitant , quadruple , and levofloxacin-based therapies . BACKGROUND AND AIM Mercury exposure is encountered most commonly in individuals with amalgam fillings . The toxic , bactericidal , and immunosuppressive effects of mercury are well known . Furthermore , multiple antibiotic resistance can be transferred , together with mercury resistance . The aim of this study was to investigate the frequency of Helicobacter pylori infection in dyspeptic patients with amalgam fillings and the effect of the amalgam fillings on H. pylori eradication rates in these patients . PATIENTS AND METHODS Four hundred and seventy-five patients who presented with dyspeptic complaints and underwent upper gastrointestinal endoscopy and gastric biopsy were included in this study . One hundred and sixty-nine ( 35.6 % ) patients were negative and 306 ( 64.4 % ) patients were positive for H. pylori . All of the participants underwent dental examinations in a blinded manner . The participants were divided into two groups on the basis of the presence of amalgam fillings . The H. pylori-positive patients were divided randomly into three subgroups : patients who received concomitant therapy ( CT ) ( rabeprazole-amoxicillin-clarithromycin-metronidazole for 14 days ; n=122 ) ; patients who received quadruple therapy ( QT ) ( rabeprazole-tetracycline-metronidazole-colloidal bismuth subcitrate for 10 days ; n=97 ) ; and patients who received levofloxacin-based therapy ( LT ) ( rabeprazole-amoxicillin-levofloxacin for 10 days ; n=87 ) . Eradication success was detected by a urea breath test 6 weeks after the end of treatment . RESULTS The frequency of H. pylori infection was significantly lower in the filling group compared with the nonfilling group ( 53.7 and 78.8 % , respectively ; P < 0.001 ) . The eradication rates in the CT , QT , and LT groups were 65.5 , 67.0 , and 58.6 % , respectively , in the intention-to-treat ( ITT ) analysis and 69.6 , 70.7 , and 62.2 % , respectively , in the per-protocol ( PP ) analysis . In all of the H. pylori-positive patients and separately in the CT and LT groups , the eradication rates were significantly lower in the filling group compared with the nonfilling group . However , in the QT group , there was no significant difference between the patients with and without fillings ( P=0.001 , 0.003 , 0.012 , 0.14 , respectively ) . Logistic regression analysis showed that the absence of amalgam filling exerts independent effects on the increased frequency of H. pylori infection and increased rate of H. pylori eradication . CONCLUSION This is the first study to show a lower frequency of H. pylori colonization in patients with amalgam fillings than without and that H. pylori eradication rates are lower in patients with amalgam fillings compared to those without ."
],
"offsets": [
[
0,
2954
]
]
}
] | [
{
"id": "71311",
"type": "Intervention_Physical",
"text": [
"amalgam dental fillings"
],
"offsets": [
[
14,
37
]
],
"normalized": []
},
{
"id": "71312",
"type": "Intervention_Pharmacological",
"text": [
"concomitant"
],
"offsets": [
[
145,
156
]
],
"normalized": []
},
{
"id": "71313",
"type": "Intervention_Pharmacological",
"text": [
"quadruple"
],
"offsets": [
[
159,
168
]
],
"normalized": []
},
{
"id": "71314",
"type": "Intervention_Pharmacological",
"text": [
"levofloxacin-based therapies"
],
"offsets": [
[
175,
203
]
],
"normalized": []
},
{
"id": "71315",
"type": "Intervention_Physical",
"text": [
"amalgam fillings"
],
"offsets": [
[
291,
307
]
],
"normalized": []
},
{
"id": "71316",
"type": "Intervention_Pharmacological",
"text": [
"concomitant therapy ( CT )"
],
"offsets": [
[
1305,
1331
]
],
"normalized": []
},
{
"id": "71317",
"type": "Intervention_Pharmacological",
"text": [
"rabeprazole-amoxicillin-clarithromycin-metronidazole"
],
"offsets": [
[
1334,
1386
]
],
"normalized": []
},
{
"id": "71318",
"type": "Intervention_Pharmacological",
"text": [
"quadruple therapy ( QT ) ( rabeprazole-tetracycline-metronidazole-colloidal bismuth subcitrate"
],
"offsets": [
[
1433,
1527
]
],
"normalized": []
},
{
"id": "71319",
"type": "Intervention_Pharmacological",
"text": [
"levofloxacin-based therapy ( LT ) ( rabeprazole-amoxicillin-levofloxacin"
],
"offsets": [
[
1577,
1649
]
],
"normalized": []
},
{
"id": "71320",
"type": "Intervention_Physical",
"text": [
"filling"
],
"offsets": [
[
29,
36
]
],
"normalized": []
},
{
"id": "71321",
"type": "Intervention_Pharmacological",
"text": [
"CT"
],
"offsets": [
[
1327,
1329
]
],
"normalized": []
},
{
"id": "71322",
"type": "Intervention_Pharmacological",
"text": [
"QT"
],
"offsets": [
[
1453,
1455
]
],
"normalized": []
},
{
"id": "71323",
"type": "Intervention_Pharmacological",
"text": [
"LT"
],
"offsets": [
[
1606,
1608
]
],
"normalized": []
},
{
"id": "71324",
"type": "Intervention_Pharmacological",
"text": [
"CT"
],
"offsets": [
[
1327,
1329
]
],
"normalized": []
},
{
"id": "71325",
"type": "Intervention_Pharmacological",
"text": [
"LT"
],
"offsets": [
[
1606,
1608
]
],
"normalized": []
},
{
"id": "71326",
"type": "Intervention_Physical",
"text": [
"filling"
],
"offsets": [
[
29,
36
]
],
"normalized": []
},
{
"id": "71327",
"type": "Intervention_Control",
"text": [
"nonfilling"
],
"offsets": [
[
1873,
1883
]
],
"normalized": []
},
{
"id": "71328",
"type": "Intervention_Pharmacological",
"text": [
"QT"
],
"offsets": [
[
1453,
1455
]
],
"normalized": []
},
{
"id": "71329",
"type": "Intervention_Physical",
"text": [
"amalgam fillings"
],
"offsets": [
[
291,
307
]
],
"normalized": []
},
{
"id": "71330",
"type": "Intervention_Physical",
"text": [
"amalgam fillings"
],
"offsets": [
[
291,
307
]
],
"normalized": []
},
{
"id": "71331",
"type": "Outcome_Physical",
"text": [
"frequency of Helicobacter pylori infection and H."
],
"offsets": [
[
45,
94
]
],
"normalized": []
},
{
"id": "71332",
"type": "Outcome_Other",
"text": [
"pylori eradication rates"
],
"offsets": [
[
95,
119
]
],
"normalized": []
},
{
"id": "71333",
"type": "Outcome_Physical",
"text": [
"frequency of Helicobacter pylori infection"
],
"offsets": [
[
45,
87
]
],
"normalized": []
},
{
"id": "71334",
"type": "Outcome_Physical",
"text": [
"H."
],
"offsets": [
[
92,
94
]
],
"normalized": []
},
{
"id": "71335",
"type": "Outcome_Other",
"text": [
"pylori eradication rates"
],
"offsets": [
[
95,
119
]
],
"normalized": []
},
{
"id": "71336",
"type": "Outcome_Other",
"text": [
"Eradication success"
],
"offsets": [
[
1673,
1692
]
],
"normalized": []
},
{
"id": "71337",
"type": "Outcome_Other",
"text": [
"frequency"
],
"offsets": [
[
45,
54
]
],
"normalized": []
},
{
"id": "71338",
"type": "Outcome_Physical",
"text": [
"pylori infection"
],
"offsets": [
[
71,
87
]
],
"normalized": []
},
{
"id": "71339",
"type": "Outcome_Other",
"text": [
"eradication rates"
],
"offsets": [
[
102,
119
]
],
"normalized": []
},
{
"id": "71340",
"type": "Outcome_Other",
"text": [
"eradication rates"
],
"offsets": [
[
102,
119
]
],
"normalized": []
},
{
"id": "71341",
"type": "Outcome_Physical",
"text": [
"frequency of H. pylori infection"
],
"offsets": [
[
1777,
1809
]
],
"normalized": []
},
{
"id": "71342",
"type": "Outcome_Physical",
"text": [
"increased rate of H. pylori eradication"
],
"offsets": [
[
2670,
2709
]
],
"normalized": []
},
{
"id": "71343",
"type": "Outcome_Physical",
"text": [
"frequency of H. pylori colonization"
],
"offsets": [
[
2763,
2798
]
],
"normalized": []
},
{
"id": "71344",
"type": "Outcome_Physical",
"text": [
"H. pylori eradication rates"
],
"offsets": [
[
92,
119
]
],
"normalized": []
},
{
"id": "71345",
"type": "Participant_Condition",
"text": [
"patients treated with concomitant"
],
"offsets": [
[
123,
156
]
],
"normalized": []
},
{
"id": "71346",
"type": "Participant_Condition",
"text": [
"quadruple , and levofloxacin-based therapies"
],
"offsets": [
[
159,
203
]
],
"normalized": []
},
{
"id": "71347",
"type": "Participant_Condition",
"text": [
"individuals with amalgam fillings ."
],
"offsets": [
[
274,
309
]
],
"normalized": []
},
{
"id": "71348",
"type": "Participant_Condition",
"text": [
"dyspeptic patients with amalgam fillings"
],
"offsets": [
[
587,
627
]
],
"normalized": []
},
{
"id": "71349",
"type": "Participant_Condition",
"text": [
"the effect of the amalgam fillings on H. pylori eradication rates in these patients"
],
"offsets": [
[
632,
715
]
],
"normalized": []
},
{
"id": "71350",
"type": "Participant_Sample-size",
"text": [
"Four hundred and seventy-five patients"
],
"offsets": [
[
739,
777
]
],
"normalized": []
},
{
"id": "71351",
"type": "Participant_Condition",
"text": [
"dyspeptic complaints"
],
"offsets": [
[
797,
817
]
],
"normalized": []
},
{
"id": "71352",
"type": "Participant_Condition",
"text": [
"underwent upper gastrointestinal endoscopy"
],
"offsets": [
[
822,
864
]
],
"normalized": []
},
{
"id": "71353",
"type": "Participant_Condition",
"text": [
"gastric biopsy"
],
"offsets": [
[
869,
883
]
],
"normalized": []
},
{
"id": "71354",
"type": "Participant_Condition",
"text": [
"pylori-positive patients"
],
"offsets": [
[
1213,
1237
]
],
"normalized": []
},
{
"id": "71355",
"type": "Participant_Condition",
"text": [
"patients with amalgam fillings"
],
"offsets": [
[
597,
627
]
],
"normalized": []
},
{
"id": "71356",
"type": "Participant_Condition",
"text": [
"patients with amalgam fillings"
],
"offsets": [
[
597,
627
]
],
"normalized": []
}
] | [] | [] | [] |
71357 | 25920470 | [
{
"id": "71358",
"type": "document",
"text": [
"Effect of motor training involving the less-affected side ( MTLA ) in post-stroke subjects : a pilot randomized controlled trial . INTRODUCTION Poststroke , less-severe motor impairment occurs on the ipsilesional side of body . The objective of the present study was to evaluate the effectiveness of the motor training involving the less-affected side ( MTLA ) in stroke . METHODS This was a randomized , controlled , double-blinded pilot study conducted in the occupational therapy unit of a rehabilitation Institute . A convenience sample of 35 stroke subjects ( mean poststroke duration , 28.76 weeks ) was randomized into two groups ( the experimental group : 17 and control group : 18 ) . Thirty-two participants completed the entire study protocol . The experimental group and control group were provided MTLA and neurophysiological-based conventional therapy respectively . Both the groups received 24 treatment sessions ( 60 minutes each ) over the period of two months . The Affected side was assessed using Brunnstrom recovery stage ( BRS ) and Fugl-Meyer assessment ( FMA ) whereas the less-affected side was evaluated by Minnesota manual dexterity test ( MMDT ) , Purdue peg board test ( PPBT ) and Manual Muscle Testing ( MMT ) . RESULTS Postintervention , the less-affected side of experimental group demonstrated significant improvement for MMDT ( P = 0.003 ) , PPBT ( P = 0.01 ) and MMT ( P < 0.001 to 0.043 ) in comparison to the control group . Further , as compared to the control group , the experimental group exhibited positive significant change for the measure of affected side [ BRS ( P < 0.001 ) and FMA ( P < 0.001 to 0.03 ) ] at post assessment . CONCLUSION MTLA enhanced the muscle strength , dexterity and coordination of the less-affected side as well as the motor recovery of the affected side in poststroke hemiparetic subjects ."
],
"offsets": [
[
0,
1862
]
]
}
] | [
{
"id": "71359",
"type": "Intervention_Educational",
"text": [
"motor training"
],
"offsets": [
[
10,
24
]
],
"normalized": []
},
{
"id": "71360",
"type": "Intervention_Educational",
"text": [
"motor training"
],
"offsets": [
[
10,
24
]
],
"normalized": []
},
{
"id": "71361",
"type": "Intervention_Physical",
"text": [
"MTLA and neurophysiological-based conventional therapy respectively"
],
"offsets": [
[
811,
878
]
],
"normalized": []
},
{
"id": "71362",
"type": "Outcome_Physical",
"text": [
"Brunnstrom recovery stage ( BRS )"
],
"offsets": [
[
1017,
1050
]
],
"normalized": []
},
{
"id": "71363",
"type": "Outcome_Physical",
"text": [
"Fugl-Meyer assessment ( FMA )"
],
"offsets": [
[
1055,
1084
]
],
"normalized": []
},
{
"id": "71364",
"type": "Outcome_Physical",
"text": [
"Minnesota manual dexterity test ( MMDT )"
],
"offsets": [
[
1133,
1173
]
],
"normalized": []
},
{
"id": "71365",
"type": "Outcome_Physical",
"text": [
"Purdue peg board test ( PPBT )"
],
"offsets": [
[
1176,
1206
]
],
"normalized": []
},
{
"id": "71366",
"type": "Outcome_Physical",
"text": [
"Manual Muscle Testing ( MMT )"
],
"offsets": [
[
1211,
1240
]
],
"normalized": []
},
{
"id": "71367",
"type": "Outcome_Physical",
"text": [
"MMDT"
],
"offsets": [
[
1167,
1171
]
],
"normalized": []
},
{
"id": "71368",
"type": "Outcome_Physical",
"text": [
"PPBT"
],
"offsets": [
[
1200,
1204
]
],
"normalized": []
},
{
"id": "71369",
"type": "Outcome_Physical",
"text": [
"MMT"
],
"offsets": [
[
1235,
1238
]
],
"normalized": []
},
{
"id": "71370",
"type": "Outcome_Other",
"text": [
"0.001 ) and"
],
"offsets": [
[
1614,
1625
]
],
"normalized": []
},
{
"id": "71371",
"type": "Outcome_Other",
"text": [
"CONCLUSION"
],
"offsets": [
[
1675,
1685
]
],
"normalized": []
},
{
"id": "71372",
"type": "Participant_Condition",
"text": [
"post-stroke subjects"
],
"offsets": [
[
70,
90
]
],
"normalized": []
},
{
"id": "71373",
"type": "Participant_Sample-size",
"text": [
"Thirty-two"
],
"offsets": [
[
694,
704
]
],
"normalized": []
},
{
"id": "71374",
"type": "Participant_Condition",
"text": [
"side in poststroke hemiparetic subjects"
],
"offsets": [
[
1821,
1860
]
],
"normalized": []
}
] | [] | [] | [] |
71375 | 25923852 | [
{
"id": "71376",
"type": "document",
"text": [
"A trial of d-cycloserine to treat the social deficit in older adolescents and young adults with autism spectrum disorders . Autism spectrum disorders are difficult for older adolescents and young adults as impaired social communication affects the transition to adult life . d-Cycloserine , a partial glycine agonist at the N-methyl-d-aspartic acid receptor , was tested in a double-blind randomized trial in 20 older adolescents and young adults with autism spectrum disorders using two dosing strategies ( 50 mg daily versus 50 mg weekly ) for 8 weeks with a 2-week follow-up after discontinuation . d-Cycloserine caused statistically and clinically significant improvement with no differentiation between dosing strategies on the Social Responsiveness Scale and the Aberrant Behavior Checklist before and after d-cycloserine administration ."
],
"offsets": [
[
0,
844
]
]
}
] | [
{
"id": "71377",
"type": "Intervention_Pharmacological",
"text": [
"d-cycloserine"
],
"offsets": [
[
11,
24
]
],
"normalized": []
},
{
"id": "71378",
"type": "Intervention_Pharmacological",
"text": [
"d-Cycloserine"
],
"offsets": [
[
275,
288
]
],
"normalized": []
},
{
"id": "71379",
"type": "Intervention_Pharmacological",
"text": [
"d-Cycloserine"
],
"offsets": [
[
275,
288
]
],
"normalized": []
},
{
"id": "71380",
"type": "Intervention_Pharmacological",
"text": [
"d-cycloserine"
],
"offsets": [
[
11,
24
]
],
"normalized": []
},
{
"id": "71381",
"type": "Outcome_Mental",
"text": [
"dosing strategies on the Social Responsiveness Scale and the Aberrant Behavior Checklist"
],
"offsets": [
[
708,
796
]
],
"normalized": []
},
{
"id": "71382",
"type": "Participant_Age",
"text": [
"older adolescents"
],
"offsets": [
[
56,
73
]
],
"normalized": []
},
{
"id": "71383",
"type": "Participant_Age",
"text": [
"young adults"
],
"offsets": [
[
78,
90
]
],
"normalized": []
},
{
"id": "71384",
"type": "Participant_Condition",
"text": [
"autism spectrum disorders"
],
"offsets": [
[
96,
121
]
],
"normalized": []
},
{
"id": "71385",
"type": "Participant_Condition",
"text": [
"Autism spectrum disorders"
],
"offsets": [
[
124,
149
]
],
"normalized": []
},
{
"id": "71386",
"type": "Participant_Age",
"text": [
"older adolescents"
],
"offsets": [
[
56,
73
]
],
"normalized": []
},
{
"id": "71387",
"type": "Participant_Age",
"text": [
"young adults"
],
"offsets": [
[
78,
90
]
],
"normalized": []
},
{
"id": "71388",
"type": "Participant_Sample-size",
"text": [
"20"
],
"offsets": [
[
409,
411
]
],
"normalized": []
},
{
"id": "71389",
"type": "Participant_Age",
"text": [
"older adolescents"
],
"offsets": [
[
56,
73
]
],
"normalized": []
},
{
"id": "71390",
"type": "Participant_Age",
"text": [
"young adults"
],
"offsets": [
[
78,
90
]
],
"normalized": []
},
{
"id": "71391",
"type": "Participant_Condition",
"text": [
"autism spectrum disorders"
],
"offsets": [
[
96,
121
]
],
"normalized": []
}
] | [] | [] | [] |
71392 | 25934164 | [
{
"id": "71393",
"type": "document",
"text": [
"Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system . OBJECTIVE To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive ( LNG20 ) designed for up to 7 years use . STUDY DESIGN Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label , partially randomized trial to evaluate LNG20 . The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index . Women aged 36-45 years received LNG20 for safety evaluation only . All participants had in-person or phone follow-up approximately every 3 months during the study . RESULTS A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement , including 1011 ( 57.7 % ) nulliparous and 438 ( 25.1 % ) obese women . Successful placement occurred in 1714 ( 97.9 % ) women . Six pregnancies occurred , four of which were ectopic . The Pearl Index for LNG20 was 0.15 ( 95 % CI 0.02-0.55 ) through Year 1 , 0.26 ( 95 % CI 0.10-0.57 ) through Year 2 , and 0.22 ( 95 % CI 0.08-0.49 ) through Year 3 . The cumulative life-table pregnancy rate was 0.55 ( 95 % CI 0.24-1.23 ) through 3 years . Expulsion was reported in 62 ( 3.5 % ) participants , most ( 50 [ 80.6 % ] ) during the first year of use . Of women who discontinued LNG20 and desired pregnancy , 86.8 % conceived spontaneously within 12 months . Pelvic infection was diagnosed in 10 ( 0.6 % ) women . Only 26 ( 1.5 % ) LNG20 users discontinued due to bleeding complaints . CONCLUSION The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women . IMPLICATIONS STATEMENT A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years ."
],
"offsets": [
[
0,
1895
]
]
}
] | [
{
"id": "71394",
"type": "Intervention_Pharmacological",
"text": [
"levonorgestrel-releasing"
],
"offsets": [
[
46,
70
]
],
"normalized": []
},
{
"id": "71395",
"type": "Intervention_Pharmacological",
"text": [
"levonorgestrel intrauterine contraceptive ( LNG20 )"
],
"offsets": [
[
167,
218
]
],
"normalized": []
},
{
"id": "71396",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71397",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71398",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71399",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71400",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71401",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71402",
"type": "Intervention_Pharmacological",
"text": [
"LNG20"
],
"offsets": [
[
211,
216
]
],
"normalized": []
},
{
"id": "71403",
"type": "Intervention_Pharmacological",
"text": [
"levonorgestrel-releasing intrauterine system"
],
"offsets": [
[
46,
90
]
],
"normalized": []
},
{
"id": "71404",
"type": "Participant_Condition",
"text": [
"levonorgestrel intrauterine contraceptive ( LNG20 )"
],
"offsets": [
[
167,
218
]
],
"normalized": []
},
{
"id": "71405",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71406",
"type": "Participant_Age",
"text": [
"16-45 years"
],
"offsets": [
[
299,
310
]
],
"normalized": []
},
{
"id": "71407",
"type": "Participant_Sex",
"text": [
"Women"
],
"offsets": [
[
562,
567
]
],
"normalized": []
},
{
"id": "71408",
"type": "Participant_Age",
"text": [
"36-45"
],
"offsets": [
[
573,
578
]
],
"normalized": []
},
{
"id": "71409",
"type": "Participant_Sample-size",
"text": [
"1600"
],
"offsets": [
[
746,
750
]
],
"normalized": []
},
{
"id": "71410",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71411",
"type": "Participant_Age",
"text": [
"aged 16-35 years"
],
"offsets": [
[
513,
529
]
],
"normalized": []
},
{
"id": "71412",
"type": "Participant_Sample-size",
"text": [
"151"
],
"offsets": [
[
778,
781
]
],
"normalized": []
},
{
"id": "71413",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71414",
"type": "Participant_Age",
"text": [
"aged 36-45 years"
],
"offsets": [
[
568,
584
]
],
"normalized": []
},
{
"id": "71415",
"type": "Participant_Sample-size",
"text": [
"438"
],
"offsets": [
[
875,
878
]
],
"normalized": []
},
{
"id": "71416",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71417",
"type": "Participant_Sample-size",
"text": [
"1714"
],
"offsets": [
[
937,
941
]
],
"normalized": []
},
{
"id": "71418",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71419",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71420",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
},
{
"id": "71421",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
288,
293
]
],
"normalized": []
}
] | [] | [] | [] |
71422 | 25953148 | [
{
"id": "71423",
"type": "document",
"text": [
"A Randomized Clinical Trial Comparison Between Pivotal Response Treatment ( PRT ) and Adult-Driven Applied Behavior Analysis ( ABA ) Intervention on Disruptive Behaviors in Public School Children with Autism . Children with autism often demonstrate disruptive behaviors during demanding teaching tasks . Language intervention can be particularly difficult as it involves social and communicative areas , which are challenging for this population . The purpose of this study was to compare two intervention conditions , a naturalistic approach , Pivotal Response Treatment ( PRT ) with an adult-directed ABA approach on disruptive behavior during language intervention in the public schools . A randomized clinical trial design was used with two groups of children , matched according to age , sex and mean length of utterance . The data showed that the children demonstrated significantly lower levels of disruptive behavior during the PRT condition . The results are discussed with respect to antecedent manipulations that may be helpful in reducing disruptive behavior ."
],
"offsets": [
[
0,
1072
]
]
}
] | [
{
"id": "71424",
"type": "Intervention_Psychological",
"text": [
"Pivotal Response Treatment ( PRT )"
],
"offsets": [
[
47,
81
]
],
"normalized": []
},
{
"id": "71425",
"type": "Intervention_Psychological",
"text": [
"Adult-Driven Applied Behavior Analysis ( ABA ) Intervention"
],
"offsets": [
[
86,
145
]
],
"normalized": []
},
{
"id": "71426",
"type": "Intervention_Psychological",
"text": [
"Pivotal Response Treatment ( PRT"
],
"offsets": [
[
47,
79
]
],
"normalized": []
},
{
"id": "71427",
"type": "Intervention_Psychological",
"text": [
"adult-directed ABA approach"
],
"offsets": [
[
588,
615
]
],
"normalized": []
}
] | [] | [] | [] |
71428 | 25957107 | [
{
"id": "71429",
"type": "document",
"text": [
"Effect of Chinese herbal medicine on vascular functions during 60-day head-down bed rest . PURPOSE Chinese herbal medicine is a promising countermeasure against cardiovascular dysfunction associated with a sedentary lifestyle . We examined the impact of the Chinese herb , Taikong Yangxin , on the micro- and macrovascular dysfunction associated with a 60-day bed rest . METHODS Fourteen healthy men were randomly divided into two groups : those given herbal supplement , and the control group ; the two groups underwent a 60-day bed rest . The macrovasculature was assessed by sonography . Skin microvascular functions were assessed with laser Doppler . The plasma level of endothelial microparticles ( EMPs ) , markers of endothelial injury , was determined . RESULTS Bed rest induced a 33 % decrease in the femoral artery diameter and compliance whereas carotid wall thickness , diameter , and compliance remained unchanged . The early phase of endothelium-dependent vasodilation to ACh was unmodified by bed rest , while the late phase was reduced by 30 % along with a twofold increase in EMPs . In those given Taikong Yangxin , the early phase was amplified by 2.5-fold , and the effects of bed rest on the late phase were prevented . CONCLUSION These findings indicate that Taikong Yangxin ameliorates endothelium-dependent vasodilation , likely by improving the NO pathway . The study suggests Taikong Yangxin as a new countermeasure to prevent the changes in microvascular function induced by physical inactivity ."
],
"offsets": [
[
0,
1522
]
]
}
] | [
{
"id": "71430",
"type": "Intervention_Pharmacological",
"text": [
"Chinese herbal medicine"
],
"offsets": [
[
10,
33
]
],
"normalized": []
},
{
"id": "71431",
"type": "Intervention_Pharmacological",
"text": [
"Chinese herbal medicine"
],
"offsets": [
[
10,
33
]
],
"normalized": []
},
{
"id": "71432",
"type": "Intervention_Pharmacological",
"text": [
"Chinese herb , Taikong Yangxin"
],
"offsets": [
[
258,
288
]
],
"normalized": []
},
{
"id": "71433",
"type": "Intervention_Pharmacological",
"text": [
"herbal supplement"
],
"offsets": [
[
452,
469
]
],
"normalized": []
},
{
"id": "71434",
"type": "Intervention_Educational",
"text": [
"60-day bed rest"
],
"offsets": [
[
353,
368
]
],
"normalized": []
},
{
"id": "71435",
"type": "Intervention_Pharmacological",
"text": [
"Taikong Yangxin"
],
"offsets": [
[
273,
288
]
],
"normalized": []
},
{
"id": "71436",
"type": "Outcome_Physical",
"text": [
"vascular functions"
],
"offsets": [
[
37,
55
]
],
"normalized": []
},
{
"id": "71437",
"type": "Outcome_Physical",
"text": [
"cardiovascular dysfunction"
],
"offsets": [
[
161,
187
]
],
"normalized": []
},
{
"id": "71438",
"type": "Outcome_Physical",
"text": [
"micro- and macrovascular dysfunction"
],
"offsets": [
[
298,
334
]
],
"normalized": []
},
{
"id": "71439",
"type": "Outcome_Physical",
"text": [
"macrovasculature"
],
"offsets": [
[
545,
561
]
],
"normalized": []
},
{
"id": "71440",
"type": "Outcome_Physical",
"text": [
"Skin microvascular functions"
],
"offsets": [
[
591,
619
]
],
"normalized": []
},
{
"id": "71441",
"type": "Outcome_Physical",
"text": [
"plasma level of endothelial microparticles ( EMPs )"
],
"offsets": [
[
659,
710
]
],
"normalized": []
},
{
"id": "71442",
"type": "Outcome_Physical",
"text": [
"endothelial injury"
],
"offsets": [
[
724,
742
]
],
"normalized": []
},
{
"id": "71443",
"type": "Outcome_Physical",
"text": [
"femoral artery diameter"
],
"offsets": [
[
810,
833
]
],
"normalized": []
},
{
"id": "71444",
"type": "Outcome_Mental",
"text": [
"compliance"
],
"offsets": [
[
838,
848
]
],
"normalized": []
},
{
"id": "71445",
"type": "Outcome_Physical",
"text": [
"carotid wall thickness , diameter"
],
"offsets": [
[
857,
890
]
],
"normalized": []
},
{
"id": "71446",
"type": "Outcome_Mental",
"text": [
"compliance"
],
"offsets": [
[
838,
848
]
],
"normalized": []
},
{
"id": "71447",
"type": "Outcome_Physical",
"text": [
"early phase of endothelium-dependent vasodilation to ACh"
],
"offsets": [
[
933,
989
]
],
"normalized": []
},
{
"id": "71448",
"type": "Outcome_Physical",
"text": [
"late phase"
],
"offsets": [
[
1029,
1039
]
],
"normalized": []
},
{
"id": "71449",
"type": "Outcome_Physical",
"text": [
"early phase"
],
"offsets": [
[
933,
944
]
],
"normalized": []
},
{
"id": "71450",
"type": "Outcome_Physical",
"text": [
"effects of bed rest"
],
"offsets": [
[
1185,
1204
]
],
"normalized": []
},
{
"id": "71451",
"type": "Outcome_Physical",
"text": [
"endothelium-dependent vasodilation"
],
"offsets": [
[
948,
982
]
],
"normalized": []
},
{
"id": "71452",
"type": "Outcome_Physical",
"text": [
"microvascular function"
],
"offsets": [
[
596,
618
]
],
"normalized": []
},
{
"id": "71453",
"type": "Participant_Condition",
"text": [
"cardiovascular dysfunction"
],
"offsets": [
[
161,
187
]
],
"normalized": []
},
{
"id": "71454",
"type": "Participant_Sample-size",
"text": [
"Fourteen"
],
"offsets": [
[
379,
387
]
],
"normalized": []
},
{
"id": "71455",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
396,
399
]
],
"normalized": []
}
] | [] | [] | [] |
71456 | 25963425 | [
{
"id": "71457",
"type": "document",
"text": [
"The SOFT trial : a Phase III study of the dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine S-1 and oxaliplatin ( SOX ) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer . A combination of oxaliplatin , leucovorin and 5-fluorouracil ( FOLFOX ) plus bevacizumab has been widely used for the first-line chemotherapy of metastatic colorectal cancer ( mCRC ) . S-1 is an oral fluoropyrimidine preparation that combines tegafur , a prodrug of 5-fluorouracil , with two modulators . Several studies of combination chemotherapy with oxaliplatin plus S-1 ( SOX ) conducted in Asia have reported promising efficacy and safety in patients with mCRC , suggesting the potential to replace mFOLFOX6 . The SOFT trial ( JapicCTI-090699 ) was a randomized Phase III trial designed to evaluate the noninferiority of SOX plus bevacizumab to mFOLFOX6 plus bevacizumab in patients with mCRC . This review summarizes the drug concept of S-1 and the results of clinical trials of S-1 and SOX in CRC and presents an overview of the SOFT trial ."
],
"offsets": [
[
0,
1058
]
]
}
] | [
{
"id": "71458",
"type": "Intervention_Pharmacological",
"text": [
"dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine S-1 and oxaliplatin ( SOX ) plus bevacizumab"
],
"offsets": [
[
42,
146
]
],
"normalized": []
},
{
"id": "71459",
"type": "Intervention_Pharmacological",
"text": [
"oxaliplatin , leucovorin and 5-fluorouracil ( FOLFOX ) plus bevacizumab"
],
"offsets": [
[
226,
297
]
],
"normalized": []
},
{
"id": "71460",
"type": "Intervention_Physical",
"text": [
"chemotherapy"
],
"offsets": [
[
161,
173
]
],
"normalized": []
},
{
"id": "71461",
"type": "Intervention_Pharmacological",
"text": [
"oxaliplatin plus S-1 ( SOX )"
],
"offsets": [
[
563,
591
]
],
"normalized": []
},
{
"id": "71462",
"type": "Intervention_Pharmacological",
"text": [
"mFOLFOX6"
],
"offsets": [
[
714,
722
]
],
"normalized": []
},
{
"id": "71463",
"type": "Intervention_Pharmacological",
"text": [
"SOX plus bevacizumab to mFOLFOX6 plus bevacizumab"
],
"offsets": [
[
836,
885
]
],
"normalized": []
},
{
"id": "71464",
"type": "Intervention_Pharmacological",
"text": [
"S-1 and SOX"
],
"offsets": [
[
995,
1006
]
],
"normalized": []
},
{
"id": "71465",
"type": "Outcome_Physical",
"text": [
"evaluate the noninferiority of SOX"
],
"offsets": [
[
805,
839
]
],
"normalized": []
},
{
"id": "71466",
"type": "Outcome_Physical",
"text": [
"bevacizumab to mFOLFOX6 plus bevacizumab"
],
"offsets": [
[
845,
885
]
],
"normalized": []
},
{
"id": "71467",
"type": "Outcome_Physical",
"text": [
"mCRC"
],
"offsets": [
[
385,
389
]
],
"normalized": []
},
{
"id": "71468",
"type": "Participant_Condition",
"text": [
"metastatic colorectal cancer ."
],
"offsets": [
[
178,
208
]
],
"normalized": []
},
{
"id": "71469",
"type": "Participant_Condition",
"text": [
"metastatic colorectal cancer ( mCRC ) ."
],
"offsets": [
[
354,
393
]
],
"normalized": []
},
{
"id": "71470",
"type": "Participant_Condition",
"text": [
"patients with mCRC"
],
"offsets": [
[
657,
675
]
],
"normalized": []
},
{
"id": "71471",
"type": "Participant_Condition",
"text": [
"patients with mCRC"
],
"offsets": [
[
657,
675
]
],
"normalized": []
}
] | [] | [] | [] |
71472 | 25963675 | [
{
"id": "71473",
"type": "document",
"text": [
"Comparison of 4 supraglotttic devices used by paramedics during simulated CPR : a randomized controlled crossover trial . BACKGROUND Ensuring an open airway during cardiopulmonary resuscitation is fundamental . The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel . METHODS Four devices were compared in a simulated resuscitation scenario : ILMA ( Intavent Direct Ltd , Buckinghamshire , United Kingdom ) , Cobra PLA ( Engineered Medical Systems Inc , Indianapolis , IN ) , Supraglottic Airway Laryngopharyngeal Tube ( SALT ) ( ECOLAB , St. Paul , MN ) , and Air-Q ( Mercury Medical , Clearwater , FL ) . A group of 210 paramedics intubated a manikin with continuous chest compressions . RESULTS The mean times to intubation were 40.46 ± 4.64 , 33.96 ± 6.23 , 17.2 ± 4.63 , and 49.23 ± 13.19 seconds ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) . The success ratios of blind intubation for the devices were 86.7 % , 85.7 % , 100 % , and 71.4 % ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) . CONCLUSION The study showed that the most efficient device with the shortest blind intubation time was the SALT device ."
],
"offsets": [
[
0,
1216
]
]
}
] | [
{
"id": "71474",
"type": "Intervention_Physical",
"text": [
"supraglotttic devices"
],
"offsets": [
[
16,
37
]
],
"normalized": []
},
{
"id": "71475",
"type": "Intervention_Physical",
"text": [
"ILMA"
],
"offsets": [
[
434,
438
]
],
"normalized": []
},
{
"id": "71476",
"type": "Intervention_Physical",
"text": [
"Cobra PLA"
],
"offsets": [
[
500,
509
]
],
"normalized": []
},
{
"id": "71477",
"type": "Intervention_Physical",
"text": [
"Supraglottic Airway Laryngopharyngeal Tube ( SALT )"
],
"offsets": [
[
567,
618
]
],
"normalized": []
},
{
"id": "71478",
"type": "Intervention_Physical",
"text": [
"Air-Q"
],
"offsets": [
[
652,
657
]
],
"normalized": []
},
{
"id": "71479",
"type": "Outcome_Physical",
"text": [
"The success ratios of blind intubation"
],
"offsets": [
[
946,
984
]
],
"normalized": []
},
{
"id": "71480",
"type": "Participant_Sample-size",
"text": [
"210"
],
"offsets": [
[
709,
712
]
],
"normalized": []
}
] | [] | [] | [] |
71481 | 25973096 | [
{
"id": "71482",
"type": "document",
"text": [
"Comparison of the neuroprotective effects and recovery profiles of isoflurane , sevoflurane and desflurane as neurosurgical pre-conditioning on ischemia/reperfusion cerebral injury . BACKGROUND There are a few reports regarding the comparison of these anesthetic agents , but previous studies mainly focus on the veterinary anesthesiology . Less attention has been focused comparing the effectiveness of these inhalational anesthetic agents in neurosurgery . This lack of interest is regretful particularly considering the fact that anesthetics during neurosurgery are an issue of extreme sensitivity and subtlety , where the cerebral oxygenation process plays a significant role in the neuroprotective mechanisms . OBJECTIVE The purpose of this retrospective study is to contribute to the existing knowledge of the comparative studies of the volatile anesthetic agents such as isoflurane , sevoflurane and desflurane by evaluating the maintenance and emergence characteristics after volatile anesthetics-induced preconditioning with isoflurane , sevoflurane or desflurane for inpatient ischemia/reperfusion cerebral injury during cerebral or neural surgeries . METHODS The aim was to investigate their neuroprotective mechanisms and effects by analyzing and comparing the superiority of each agent in a Chinese patient population , in terms of faster emergence , and early and intermediate recovery . The intraoperative haemodynamic profiles and postoperative adverse effects of these three agents were also systematically analyzed . RESULTS We found that sevoflurane , when compared with isoflurane and desflurane , provided anesthesia with similar hemodynamic stability but allowed for a smoother , more rapid emergence and better quality of induction and recovery to surgical patients under clinical conditions , particularly to those who were experiencing substantial cerebral vasodilation . CONCLUSION Sevoflurane offers several advantages , including a relative lack of airway irritation , a more rapid onset and recovery , and greater hemodynamic stability than other potent inhaled agents . These properties would appear to afford sevoflurane significant clinical potential ."
],
"offsets": [
[
0,
2184
]
]
}
] | [
{
"id": "71483",
"type": "Intervention_Pharmacological",
"text": [
"isoflurane"
],
"offsets": [
[
67,
77
]
],
"normalized": []
},
{
"id": "71484",
"type": "Intervention_Pharmacological",
"text": [
"sevoflurane"
],
"offsets": [
[
80,
91
]
],
"normalized": []
},
{
"id": "71485",
"type": "Intervention_Pharmacological",
"text": [
"desflurane"
],
"offsets": [
[
96,
106
]
],
"normalized": []
},
{
"id": "71486",
"type": "Intervention_Pharmacological",
"text": [
"isoflurane"
],
"offsets": [
[
67,
77
]
],
"normalized": []
},
{
"id": "71487",
"type": "Intervention_Pharmacological",
"text": [
"sevoflurane"
],
"offsets": [
[
80,
91
]
],
"normalized": []
},
{
"id": "71488",
"type": "Intervention_Pharmacological",
"text": [
"desflurane"
],
"offsets": [
[
96,
106
]
],
"normalized": []
},
{
"id": "71489",
"type": "Intervention_Pharmacological",
"text": [
"isoflurane"
],
"offsets": [
[
67,
77
]
],
"normalized": []
},
{
"id": "71490",
"type": "Intervention_Pharmacological",
"text": [
"sevoflurane"
],
"offsets": [
[
80,
91
]
],
"normalized": []
},
{
"id": "71491",
"type": "Intervention_Pharmacological",
"text": [
"desflurane"
],
"offsets": [
[
96,
106
]
],
"normalized": []
},
{
"id": "71492",
"type": "Intervention_Pharmacological",
"text": [
"sevoflurane"
],
"offsets": [
[
80,
91
]
],
"normalized": []
},
{
"id": "71493",
"type": "Intervention_Pharmacological",
"text": [
"isoflurane"
],
"offsets": [
[
67,
77
]
],
"normalized": []
},
{
"id": "71494",
"type": "Intervention_Pharmacological",
"text": [
"desflurane"
],
"offsets": [
[
96,
106
]
],
"normalized": []
},
{
"id": "71495",
"type": "Intervention_Pharmacological",
"text": [
"Sevoflurane"
],
"offsets": [
[
1908,
1919
]
],
"normalized": []
},
{
"id": "71496",
"type": "Outcome_Adverse-effects",
"text": [
"neuroprotective effects"
],
"offsets": [
[
18,
41
]
],
"normalized": []
},
{
"id": "71497",
"type": "Outcome_Other",
"text": [
"recovery profiles"
],
"offsets": [
[
46,
63
]
],
"normalized": []
},
{
"id": "71498",
"type": "Outcome_Adverse-effects",
"text": [
"effects"
],
"offsets": [
[
34,
41
]
],
"normalized": []
},
{
"id": "71499",
"type": "Outcome_Other",
"text": [
"intraoperative haemodynamic profiles"
],
"offsets": [
[
1406,
1442
]
],
"normalized": []
},
{
"id": "71500",
"type": "Outcome_Adverse-effects",
"text": [
"postoperative adverse effects"
],
"offsets": [
[
1447,
1476
]
],
"normalized": []
},
{
"id": "71501",
"type": "Outcome_Other",
"text": [
"emergence"
],
"offsets": [
[
952,
961
]
],
"normalized": []
},
{
"id": "71502",
"type": "Outcome_Other",
"text": [
"quality of induction and recovery"
],
"offsets": [
[
1734,
1767
]
],
"normalized": []
},
{
"id": "71503",
"type": "Outcome_Physical",
"text": [
"airway irritation"
],
"offsets": [
[
1977,
1994
]
],
"normalized": []
},
{
"id": "71504",
"type": "Outcome_Other",
"text": [
"onset and recovery"
],
"offsets": [
[
2010,
2028
]
],
"normalized": []
},
{
"id": "71505",
"type": "Outcome_Physical",
"text": [
"hemodynamic stability"
],
"offsets": [
[
1651,
1672
]
],
"normalized": []
},
{
"id": "71506",
"type": "Participant_Condition",
"text": [
"ischemia/reperfusion cerebral injury"
],
"offsets": [
[
144,
180
]
],
"normalized": []
},
{
"id": "71507",
"type": "Participant_Condition",
"text": [
"neurosurgery"
],
"offsets": [
[
444,
456
]
],
"normalized": []
},
{
"id": "71508",
"type": "Participant_Condition",
"text": [
"ischemia/reperfusion cerebral injury"
],
"offsets": [
[
144,
180
]
],
"normalized": []
},
{
"id": "71509",
"type": "Participant_Condition",
"text": [
"substantial cerebral vasodilation"
],
"offsets": [
[
1861,
1894
]
],
"normalized": []
}
] | [] | [] | [] |
71510 | 25978402 | [
{
"id": "71511",
"type": "document",
"text": [
"Multicomponent interdisciplinary group intervention for self-management of fibromyalgia : a mixed-methods randomized controlled trial . BACKGROUND This study evaluated the efficacy of the PASSAGE Program , a structured multicomponent interdisciplinary group intervention for the self-management of FMS . METHODS A mixed-methods randomized controlled trial ( intervention ( INT ) vs. waitlist ( WL ) ) was conducted with patients suffering from FMS . Data were collected at baseline ( T0 ) , at the end of the intervention ( T1 ) , and 3 months later ( T2 ) . The primary outcome was change in pain intensity ( 0-10 ) . Secondary outcomes were fibromyalgia severity , pain interference , sleep quality , pain coping strategies , depression , health-related quality of life , patient global impression of change ( PGIC ) , and perceived pain relief . Qualitative group interviews with a subset of patients were also conducted . Complete data from T0 to T2 were available for 43 patients . RESULTS The intervention had a statistically significant impact on the three PGIC measures . At the end of the PASSAGE Program , the percentages of patients who perceived overall improvement in their pain levels , functioning and quality of life were significantly higher in the INT Group ( 73 % , 55 % , 77 % respectively ) than in the WL Group ( 8 % , 12 % , 20 % ) . The same differences were observed 3 months post-intervention ( Intervention group : 62 % , 43 % , 38 % vs Waitlist Group : 13 % , 13 % , 9 % ) . The proportion of patients who reported ≥ 50 % pain relief was also significantly higher in the INT Group at the end of the intervention ( 36 % vs 12 % ) and 3 months post-intervention ( 33 % vs 4 % ) . Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention . The improvement , however , was not reflected in the primary outcome and other secondary outcome measures . CONCLUSION The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms . We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients ' experience . TRIAL REGISTRATION International Standard Randomized Controlled Trial Number Register ISRCTN14526380 ."
],
"offsets": [
[
0,
2290
]
]
}
] | [
{
"id": "71512",
"type": "Intervention_Educational",
"text": [
"PASSAGE Program"
],
"offsets": [
[
188,
203
]
],
"normalized": []
},
{
"id": "71513",
"type": "Intervention_Educational",
"text": [
"multicomponent interdisciplinary group intervention"
],
"offsets": [
[
219,
270
]
],
"normalized": []
},
{
"id": "71514",
"type": "Intervention_Educational",
"text": [
"( intervention ( INT ) vs."
],
"offsets": [
[
356,
382
]
],
"normalized": []
},
{
"id": "71515",
"type": "Intervention_Control",
"text": [
"waitlist ( WL )"
],
"offsets": [
[
383,
398
]
],
"normalized": []
},
{
"id": "71516",
"type": "Intervention_Educational",
"text": [
")"
],
"offsets": [
[
377,
378
]
],
"normalized": []
},
{
"id": "71517",
"type": "Outcome_Pain",
"text": [
"pain intensity"
],
"offsets": [
[
593,
607
]
],
"normalized": []
},
{
"id": "71518",
"type": "Outcome_Adverse-effects",
"text": [
"fibromyalgia severity"
],
"offsets": [
[
643,
664
]
],
"normalized": []
},
{
"id": "71519",
"type": "Outcome_Pain",
"text": [
"pain interference"
],
"offsets": [
[
667,
684
]
],
"normalized": []
},
{
"id": "71520",
"type": "Outcome_Physical",
"text": [
"sleep quality"
],
"offsets": [
[
687,
700
]
],
"normalized": []
},
{
"id": "71521",
"type": "Outcome_Pain",
"text": [
"pain coping strategies"
],
"offsets": [
[
703,
725
]
],
"normalized": []
},
{
"id": "71522",
"type": "Outcome_Mental",
"text": [
"depression"
],
"offsets": [
[
728,
738
]
],
"normalized": []
},
{
"id": "71523",
"type": "Outcome_Other",
"text": [
"health-related quality of life"
],
"offsets": [
[
741,
771
]
],
"normalized": []
},
{
"id": "71524",
"type": "Outcome_Other",
"text": [
"patient global impression of change ( PGIC )"
],
"offsets": [
[
774,
818
]
],
"normalized": []
},
{
"id": "71525",
"type": "Outcome_Pain",
"text": [
"perceived pain relief"
],
"offsets": [
[
825,
846
]
],
"normalized": []
},
{
"id": "71526",
"type": "Outcome_Pain",
"text": [
"pain levels"
],
"offsets": [
[
1187,
1198
]
],
"normalized": []
},
{
"id": "71527",
"type": "Outcome_Other",
"text": [
"functioning and quality of life"
],
"offsets": [
[
1201,
1232
]
],
"normalized": []
},
{
"id": "71528",
"type": "Outcome_Pain",
"text": [
"≥ 50 % pain relief"
],
"offsets": [
[
1543,
1561
]
],
"normalized": []
},
{
"id": "71529",
"type": "Participant_Condition",
"text": [
"fibromyalgia"
],
"offsets": [
[
75,
87
]
],
"normalized": []
},
{
"id": "71530",
"type": "Participant_Condition",
"text": [
"FMS"
],
"offsets": [
[
298,
301
]
],
"normalized": []
},
{
"id": "71531",
"type": "Participant_Condition",
"text": [
"patients suffering from FMS"
],
"offsets": [
[
420,
447
]
],
"normalized": []
},
{
"id": "71532",
"type": "Participant_Sample-size",
"text": [
"43 patients"
],
"offsets": [
[
973,
984
]
],
"normalized": []
},
{
"id": "71533",
"type": "Participant_Condition",
"text": [
"helping FMS patients"
],
"offsets": [
[
1987,
2007
]
],
"normalized": []
},
{
"id": "71534",
"type": "Participant_Condition",
"text": [
"on FMS"
],
"offsets": [
[
2106,
2112
]
],
"normalized": []
}
] | [] | [] | [] |
71535 | 25992523 | [
{
"id": "71536",
"type": "document",
"text": [
"The effects of bromazepam over the central and frontal areas during a motor task : an EEG study . The present study investigates the influence of bromazepam while executing a motor task . Specifically , we intend to analyze the changes in alpha absolute power under two experimental conditions , bromazepam and placebo . We also included analyses of theta and beta frequencies . We collected electroencephalographic data before , during , and after motor task execution . We used a Two Way ANOVA to investigate the condition ( PL × Br6 mg ) and moment ( pre and post ) variables for the following electrodes : Fp1 , Fp2 , F7 , F3 , Fz , F4 , F8 , C3 , CZ and C4 . We found a main effect for condition on the electrodes FP1 , F7 , F3 , Fz , F4 , C3 and CZ , for alpha and beta bands . For beta band we also found a main effect for condition on the electrodes Fp2 , F8 and C4 ; for theta band we identified a main effect for condition on C3 , Cz and C4 electrodes . This finding suggests that the motor task did not have any influence on the electrocortical activity in alpha , and that the existing modifications were a consequence due merely to the drug use . Despite its anxiolytic and sedative action , bromazepam did not show any significant changes when the individuals executed a finger extension motor task ."
],
"offsets": [
[
0,
1314
]
]
}
] | [
{
"id": "71537",
"type": "Intervention_Pharmacological",
"text": [
"bromazepam"
],
"offsets": [
[
15,
25
]
],
"normalized": []
},
{
"id": "71538",
"type": "Intervention_Pharmacological",
"text": [
"bromazepam"
],
"offsets": [
[
15,
25
]
],
"normalized": []
},
{
"id": "71539",
"type": "Intervention_Pharmacological",
"text": [
"bromazepam"
],
"offsets": [
[
15,
25
]
],
"normalized": []
},
{
"id": "71540",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
311,
318
]
],
"normalized": []
},
{
"id": "71541",
"type": "Intervention_Physical",
"text": [
"electroencephalographic data before , during , and after motor task execution"
],
"offsets": [
[
392,
469
]
],
"normalized": []
},
{
"id": "71542",
"type": "Outcome_Physical",
"text": [
"alpha absolute power"
],
"offsets": [
[
239,
259
]
],
"normalized": []
},
{
"id": "71543",
"type": "Outcome_Mental",
"text": [
"the electrocortical activity"
],
"offsets": [
[
1036,
1064
]
],
"normalized": []
}
] | [] | [] | [] |
71544 | 26002536 | [
{
"id": "71545",
"type": "document",
"text": [
"A Comparison of Teaching Modalities and Fidelity of Simulation Levels in Teaching Resuscitation Scenarios . INTRODUCTION The purpose of our study was to examine the ability of novices to learn selected aspects of Advanced Cardiac Life Support ( ACLS ) in training conditions that did not incorporate simulation compared to those that contained low- and high-fidelity simulation activities . We sought to determine at what level additional educational opportunities and simulation fidelity become superfluous with respect to learning outcomes . METHODS Totally 39 medical students and physician assistant students were randomly assigned to 4 training conditions : control ( lecture only ) , video-based didactic instruction , low- , and high-fidelity simulation activities . Participants were assessed using a baseline written pretest of ACLS knowledge . Following this , all participants received a lecture outlining ACLS science and algorithm interpretation . Participants were then trained in specific aspects of ACLS according to their assigned instructional condition . After training , each participant was assessed via a Megacode performance examination and a written posttest . RESULTS All groups performed significantly better on the written posttest compared with the pretest ( p < 0.001 ) ; however , no groups outperformed any other groups . On the Megacode performance test , the video-based , low- , and high-fidelity groups performed significantly better than the control group ( p = 0.028 , p < 0.001 , p = 0.019 ) . Equivalence testing revealed that the high-fidelity simulation condition was statistically equivalent to the video-based and low-fidelity simulation conditions . CONCLUSION Video-based and simulation-based training is associated with better learning outcomes when compared with traditional didactic lectures only . Video-based , low-fidelity , and high-fidelity simulation training yield equivalent outcomes , which may indicate that high-fidelity simulation is superfluous for the novice trainee ."
],
"offsets": [
[
0,
2030
]
]
}
] | [
{
"id": "71546",
"type": "Intervention_Educational",
"text": [
"simulation"
],
"offsets": [
[
300,
310
]
],
"normalized": []
},
{
"id": "71547",
"type": "Intervention_Physical",
"text": [
"low- and high-fidelity simulation"
],
"offsets": [
[
344,
377
]
],
"normalized": []
},
{
"id": "71548",
"type": "Intervention_Control",
"text": [
"control"
],
"offsets": [
[
663,
670
]
],
"normalized": []
},
{
"id": "71549",
"type": "Intervention_Physical",
"text": [
"video-based didactic instruction"
],
"offsets": [
[
690,
722
]
],
"normalized": []
},
{
"id": "71550",
"type": "Intervention_Physical",
"text": [
"low- , and high-fidelity simulation"
],
"offsets": [
[
725,
760
]
],
"normalized": []
},
{
"id": "71551",
"type": "Intervention_Educational",
"text": [
"activities"
],
"offsets": [
[
378,
388
]
],
"normalized": []
},
{
"id": "71552",
"type": "Intervention_Physical",
"text": [
"lecture outlining ACLS science"
],
"offsets": [
[
899,
929
]
],
"normalized": []
},
{
"id": "71553",
"type": "Intervention_Physical",
"text": [
"video-based"
],
"offsets": [
[
690,
701
]
],
"normalized": []
},
{
"id": "71554",
"type": "Intervention_Physical",
"text": [
"low- , and high-fidelity"
],
"offsets": [
[
725,
749
]
],
"normalized": []
},
{
"id": "71555",
"type": "Intervention_Educational",
"text": [
"groups"
],
"offsets": [
[
1197,
1203
]
],
"normalized": []
},
{
"id": "71556",
"type": "Intervention_Control",
"text": [
"control group"
],
"offsets": [
[
1478,
1491
]
],
"normalized": []
},
{
"id": "71557",
"type": "Intervention_Physical",
"text": [
"high-fidelity simulation"
],
"offsets": [
[
353,
377
]
],
"normalized": []
},
{
"id": "71558",
"type": "Intervention_Educational",
"text": [
"video-based"
],
"offsets": [
[
690,
701
]
],
"normalized": []
},
{
"id": "71559",
"type": "Intervention_Physical",
"text": [
"low-fidelity simulation"
],
"offsets": [
[
1657,
1680
]
],
"normalized": []
},
{
"id": "71560",
"type": "Intervention_Educational",
"text": [
"Video-based"
],
"offsets": [
[
1705,
1716
]
],
"normalized": []
},
{
"id": "71561",
"type": "Intervention_Physical",
"text": [
"simulation-based"
],
"offsets": [
[
1721,
1737
]
],
"normalized": []
},
{
"id": "71562",
"type": "Intervention_Educational",
"text": [
"Video-based"
],
"offsets": [
[
1705,
1716
]
],
"normalized": []
},
{
"id": "71563",
"type": "Intervention_Educational",
"text": [
"low-fidelity"
],
"offsets": [
[
1657,
1669
]
],
"normalized": []
},
{
"id": "71564",
"type": "Intervention_Educational",
"text": [
"high-fidelity simulation training"
],
"offsets": [
[
1880,
1913
]
],
"normalized": []
},
{
"id": "71565",
"type": "Outcome_Mental",
"text": [
"pretest of ACLS knowledge"
],
"offsets": [
[
826,
851
]
],
"normalized": []
},
{
"id": "71566",
"type": "Outcome_Other",
"text": [
"Megacode performance examination"
],
"offsets": [
[
1127,
1159
]
],
"normalized": []
},
{
"id": "71567",
"type": "Outcome_Other",
"text": [
"written posttest ."
],
"offsets": [
[
1166,
1184
]
],
"normalized": []
},
{
"id": "71568",
"type": "Outcome_Physical",
"text": [
"Megacode performance test"
],
"offsets": [
[
1360,
1385
]
],
"normalized": []
},
{
"id": "71569",
"type": "Participant_Condition",
"text": [
"novices"
],
"offsets": [
[
176,
183
]
],
"normalized": []
},
{
"id": "71570",
"type": "Participant_Sample-size",
"text": [
"39"
],
"offsets": [
[
560,
562
]
],
"normalized": []
},
{
"id": "71571",
"type": "Participant_Condition",
"text": [
"novice trainee"
],
"offsets": [
[
2014,
2028
]
],
"normalized": []
}
] | [] | [] | [] |
71572 | 26016867 | [
{
"id": "71573",
"type": "document",
"text": [
"Supplementation with a blend of krill and salmon oil is associated with increased metabolic risk in overweight men . BACKGROUND Krill is an increasingly popular source of marine n-3 ( ω-3 ) PUFA that is seen as a premium product . However , to our knowledge , the effect of krill-oil supplementation on insulin sensitivity in humans has not been reported . OBJECTIVE We assessed whether supplementation with a blend of krill and salmon ( KS ) oil [ which is rich in eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] affects insulin sensitivity in overweight men . DESIGN The design was a randomized , double-blind , controlled crossover trial . A total of 47 men with a mean ± SD age of 46.5 ± 5.1 y , who were overweight [ body mass index ( in kg/m ( 2 ) ) from 25 to 30 ] but otherwise healthy , received 5 1-g capsules of KS oil or a control ( canola oil ) for 8 wk and crossed over to another treatment after an 8-wk washout period . The primary outcome was insulin sensitivity assessed by using the Matsuda method from an oral-glucose-tolerance test . Secondary outcomes included lipid profiles , inflammatory markers , 24-h ambulatory blood pressure , and carotid artery intimamedia thickness . RESULTS Unexpectedly , insulin sensitivity ( per the Matsuda index ) was 14 % lower with the KS oil than with the control oil ( P = 0.049 ) . A mediation analysis showed that , after controlling for the likely positive effects of blood EPA and DHA ( i.e. , the omega-3 index ) , the reduction in insulin sensitivity after KS-oil supplementation was more marked [ 27 % lower than with the control oil ( P = 0.009 ) ] . CONCLUSIONS Supplementation with a blend of KS oil is associated with decreased insulin sensitivity . Thus , krill-oil supplementation in overweight adults could exacerbate risk of diabetes and cardiovascular disease . This trial was prospectively registered at the Australian New Zealand Clinical Trials Registry as ACTRN12611000602921 ."
],
"offsets": [
[
0,
1972
]
]
}
] | [
{
"id": "71574",
"type": "Intervention_Pharmacological",
"text": [
"blend of krill and salmon oil"
],
"offsets": [
[
23,
52
]
],
"normalized": []
},
{
"id": "71575",
"type": "Intervention_Pharmacological",
"text": [
"Krill"
],
"offsets": [
[
128,
133
]
],
"normalized": []
},
{
"id": "71576",
"type": "Intervention_Pharmacological",
"text": [
"KS oil"
],
"offsets": [
[
840,
846
]
],
"normalized": []
},
{
"id": "71577",
"type": "Intervention_Control",
"text": [
"control"
],
"offsets": [
[
631,
638
]
],
"normalized": []
},
{
"id": "71578",
"type": "Outcome_Physical",
"text": [
"insulin sensitivity"
],
"offsets": [
[
303,
322
]
],
"normalized": []
},
{
"id": "71579",
"type": "Outcome_Physical",
"text": [
"lipid profiles , inflammatory markers , 24-h ambulatory blood pressure , and carotid artery intimamedia thickness"
],
"offsets": [
[
1100,
1213
]
],
"normalized": []
},
{
"id": "71580",
"type": "Outcome_Physical",
"text": [
"insulin sensitivity"
],
"offsets": [
[
303,
322
]
],
"normalized": []
},
{
"id": "71581",
"type": "Outcome_Physical",
"text": [
"insulin sensitivity"
],
"offsets": [
[
303,
322
]
],
"normalized": []
},
{
"id": "71582",
"type": "Outcome_Physical",
"text": [
"insulin sensitivity"
],
"offsets": [
[
303,
322
]
],
"normalized": []
},
{
"id": "71583",
"type": "Participant_Condition",
"text": [
"overweight"
],
"offsets": [
[
100,
110
]
],
"normalized": []
},
{
"id": "71584",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
6,
9
]
],
"normalized": []
},
{
"id": "71585",
"type": "Participant_Age",
"text": [
"in"
],
"offsets": [
[
72,
74
]
],
"normalized": []
},
{
"id": "71586",
"type": "Participant_Condition",
"text": [
"overweight"
],
"offsets": [
[
100,
110
]
],
"normalized": []
},
{
"id": "71587",
"type": "Participant_Sex",
"text": [
"men"
],
"offsets": [
[
6,
9
]
],
"normalized": []
},
{
"id": "71588",
"type": "Participant_Sample-size",
"text": [
"47 men"
],
"offsets": [
[
671,
677
]
],
"normalized": []
},
{
"id": "71589",
"type": "Participant_Age",
"text": [
"age of 46.5 ± 5.1 y ,"
],
"offsets": [
[
695,
716
]
],
"normalized": []
},
{
"id": "71590",
"type": "Participant_Condition",
"text": [
"overweight"
],
"offsets": [
[
100,
110
]
],
"normalized": []
},
{
"id": "71591",
"type": "Participant_Condition",
"text": [
"overweight"
],
"offsets": [
[
100,
110
]
],
"normalized": []
},
{
"id": "71592",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
1783,
1789
]
],
"normalized": []
}
] | [] | [] | [] |
71593 | 26035186 | [
{
"id": "71594",
"type": "document",
"text": [
"A randomized , double-blind , placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder . BACKGROUND This 8-week , randomized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) . The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter . METHOD Adults aged 18-75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score ≥ 26 were randomized ( 1:1:1 ) to receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures . Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale . RESULTS Of the 1,111 subjects screened , 469 subjects were randomized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg . Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg. Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in ≥ 5 % of subjects receiving vortioxetine . Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group . ASEX total scores were similar across groups . There were no clinically significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters . CONCLUSIONS In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects . TRIAL REGISTRATION ClinicalTrials.gov identifier : NCT01179516 ."
],
"offsets": [
[
0,
2225
]
]
}
] | [
{
"id": "71595",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
30,
48
]
],
"normalized": []
},
{
"id": "71596",
"type": "Intervention_Pharmacological",
"text": [
"vortioxetine"
],
"offsets": [
[
96,
108
]
],
"normalized": []
},
{
"id": "71597",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
30,
48
]
],
"normalized": []
},
{
"id": "71598",
"type": "Intervention_Pharmacological",
"text": [
"vortioxetine"
],
"offsets": [
[
96,
108
]
],
"normalized": []
},
{
"id": "71599",
"type": "Intervention_Pharmacological",
"text": [
"vortioxetine"
],
"offsets": [
[
96,
108
]
],
"normalized": []
},
{
"id": "71600",
"type": "Outcome_Other",
"text": [
"efficacy and safety"
],
"offsets": [
[
62,
81
]
],
"normalized": []
},
{
"id": "71601",
"type": "Outcome_Other",
"text": [
"safety and efficacy"
],
"offsets": [
[
300,
319
]
],
"normalized": []
},
{
"id": "71602",
"type": "Outcome_Physical",
"text": [
"serotonin ( 5-HT ) receptor activity"
],
"offsets": [
[
494,
530
]
],
"normalized": []
},
{
"id": "71603",
"type": "Outcome_Physical",
"text": [
"serotonin transporter ."
],
"offsets": [
[
553,
576
]
],
"normalized": []
}
] | [] | [] | [] |
71604 | 26036434 | [
{
"id": "71605",
"type": "document",
"text": [
"Melatonin improves bone mineral density at the femoral neck in postmenopausal women with osteopenia : a randomized controlled trial . Melatonin is known for its regulation of circadian rhythm . Recently , studies have shown that melatonin may have a positive effect on the skeleton . By increasing age , the melatonin levels decrease , which may lead to a further imbalanced bone remodeling . We aimed to investigate whether treatment with melatonin could improve bone mass and integrity in humans . In a double-blind RCT , we randomized 81 postmenopausal osteopenic women to 1-yr nightly treatment with melatonin 1 mg ( N = 20 ) , 3 mg ( N = 20 ) , or placebo ( N = 41 ) . At baseline and after 1-yr treatment , we measured bone mineral density ( BMD ) by dual X-ray absorptiometry , quantitative computed tomography ( QCT ) , and high-resolution peripheral QCT ( HR-pQCT ) and determined calciotropic hormones and bone markers . Mean age of the study subjects was 63 ( range 56-73 ) yr . Compared to placebo , femoral neck BMD increased by 1.4 % in response to melatonin ( P < 0.05 ) in a dose-dependent manner ( P < 0.01 ) , as BMD increased by 0.5 % in the 1 mg/day group ( P = 0.55 ) and by 2.3 % ( P < 0.01 ) in the 3 mg/day group . In the melatonin group , trabecular thickness in tibia increased by 2.2 % ( P = 0.04 ) , and volumetric bone mineral density ( vBMD ) in the spine , by 3.6 % ( P = 0.04 ) in the 3 mg/day . Treatment did not significantly affect BMD at other sites or levels of bone turnover markers ; however , 24-hr urinary calcium was decreased in response to melatonin by 12.2 % ( P = 0.02 ) . In conclusion , 1-yr treatment with melatonin increased BMD at femoral neck in a dose-dependent manner , while high-dose melatonin increased vBMD in the spine . Further studies are needed to assess the mechanisms of action and whether the positive effect of nighttime melatonin will protect against fractures ."
],
"offsets": [
[
0,
1929
]
]
}
] | [
{
"id": "71606",
"type": "Intervention_Pharmacological",
"text": [
"Melatonin"
],
"offsets": [
[
0,
9
]
],
"normalized": []
},
{
"id": "71607",
"type": "Intervention_Pharmacological",
"text": [
"Melatonin"
],
"offsets": [
[
0,
9
]
],
"normalized": []
},
{
"id": "71608",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71609",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71610",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71611",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
653,
660
]
],
"normalized": []
},
{
"id": "71612",
"type": "Intervention_Physical",
"text": [
"dual X-ray absorptiometry"
],
"offsets": [
[
757,
782
]
],
"normalized": []
},
{
"id": "71613",
"type": "Intervention_Physical",
"text": [
"quantitative computed tomography"
],
"offsets": [
[
785,
817
]
],
"normalized": []
},
{
"id": "71614",
"type": "Intervention_Physical",
"text": [
"high-resolution peripheral QCT"
],
"offsets": [
[
832,
862
]
],
"normalized": []
},
{
"id": "71615",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
653,
660
]
],
"normalized": []
},
{
"id": "71616",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71617",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71618",
"type": "Intervention_Pharmacological",
"text": [
"melatonin"
],
"offsets": [
[
229,
238
]
],
"normalized": []
},
{
"id": "71619",
"type": "Outcome_Physical",
"text": [
"femoral neck BMD"
],
"offsets": [
[
1012,
1028
]
],
"normalized": []
},
{
"id": "71620",
"type": "Outcome_Physical",
"text": [
"BMD"
],
"offsets": [
[
748,
751
]
],
"normalized": []
},
{
"id": "71621",
"type": "Outcome_Physical",
"text": [
"trabecular thickness in tibia"
],
"offsets": [
[
1264,
1293
]
],
"normalized": []
},
{
"id": "71622",
"type": "Outcome_Physical",
"text": [
"volumetric bone mineral density ( vBMD )"
],
"offsets": [
[
1332,
1372
]
],
"normalized": []
},
{
"id": "71623",
"type": "Outcome_Physical",
"text": [
"spine"
],
"offsets": [
[
1380,
1385
]
],
"normalized": []
},
{
"id": "71624",
"type": "Outcome_Physical",
"text": [
"BMD"
],
"offsets": [
[
748,
751
]
],
"normalized": []
},
{
"id": "71625",
"type": "Outcome_Physical",
"text": [
"levels of bone turnover markers ;"
],
"offsets": [
[
1489,
1522
]
],
"normalized": []
},
{
"id": "71626",
"type": "Outcome_Physical",
"text": [
"24-hr urinary calcium"
],
"offsets": [
[
1533,
1554
]
],
"normalized": []
},
{
"id": "71627",
"type": "Outcome_Physical",
"text": [
"BMD at femoral neck"
],
"offsets": [
[
1675,
1694
]
],
"normalized": []
},
{
"id": "71628",
"type": "Outcome_Physical",
"text": [
"vBMD"
],
"offsets": [
[
1366,
1370
]
],
"normalized": []
},
{
"id": "71629",
"type": "Outcome_Physical",
"text": [
"spine"
],
"offsets": [
[
1380,
1385
]
],
"normalized": []
},
{
"id": "71630",
"type": "Participant_Condition",
"text": [
"postmenopausal"
],
"offsets": [
[
63,
77
]
],
"normalized": []
},
{
"id": "71631",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
78,
83
]
],
"normalized": []
},
{
"id": "71632",
"type": "Participant_Condition",
"text": [
"osteopenia"
],
"offsets": [
[
89,
99
]
],
"normalized": []
},
{
"id": "71633",
"type": "Participant_Sample-size",
"text": [
"81"
],
"offsets": [
[
538,
540
]
],
"normalized": []
},
{
"id": "71634",
"type": "Participant_Condition",
"text": [
"postmenopausal osteopenic"
],
"offsets": [
[
541,
566
]
],
"normalized": []
},
{
"id": "71635",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
78,
83
]
],
"normalized": []
},
{
"id": "71636",
"type": "Participant_Condition",
"text": [
"treatment with melatonin 1 mg ( N = 20 ) , 3 mg ( N = 20 ) , or placebo ( N = 41 )"
],
"offsets": [
[
589,
671
]
],
"normalized": []
},
{
"id": "71637",
"type": "Participant_Age",
"text": [
"Mean age of the study subjects was 63 ( range 56-73 ) yr"
],
"offsets": [
[
931,
987
]
],
"normalized": []
}
] | [] | [] | [] |
71638 | 26036646 | [
{
"id": "71639",
"type": "document",
"text": [
"Managing repetitive behaviours in young children with autism spectrum disorder ( ASD ) : pilot randomised controlled trial of a new parent group intervention . Early intervention for autism spectrum disorder ( ASD ) tends to focus on enhancing social-communication skills . We report the acceptability , feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours ( RRB ) in young children with ASD aged 3-7 years . Forty-five families took part in the pilot RCT . A range of primary and secondary outcome measures were collected on four occasions ( baseline , 10 , 18 and 24 weeks ) to capture both independent ratings and parent-reported changes in RRB . This pilot established that parents were willing to be recruited and randomised , and the format and content of the intervention was feasible . Fidelity of delivery was high , and attendance was 90 % . A fully powered trial is now planned ."
],
"offsets": [
[
0,
971
]
]
}
] | [
{
"id": "71640",
"type": "Outcome_Mental",
"text": [
"changes in RRB"
],
"offsets": [
[
714,
728
]
],
"normalized": []
}
] | [] | [] | [] |
71641 | 26037035 | [
{
"id": "71642",
"type": "document",
"text": [
"Intradermal insulin infusion achieves faster insulin action than subcutaneous infusion for 3-day wear . Rapid uptake previously demonstrated by intradermal ( ID ) drug administration indicates compound delivery within the dermis may have clinical and pharmacological advantages for certain drug therapies . This study is the first clinical trial to evaluate continuous microneedle-based drug infusion , device wearability , and intradermal microneedle insulin kinetics over a multi-day ( 72 h ) wear period . This was a single center , open-label , two-period crossover study in T1DM patients on continuous subcutaneous insulin infusion ( CSII ) . Patients received treatment during interventional visits : one SC and one ID basal/bolus infusion of insulin aspart ( NovoRapid® U-100 ) administered over 3 days in a randomized order . Twenty-eight patients were randomized and exposed to trial product , and 23 completed the study . Bolus insulin infusions were given prior to standardized breakfast and lunch test meals on each of the three treatment days . Blood samples were drawn at predefined time points for measurements of insulin aspart and blood glucose in serum . The primary endpoint insulin Tmax demonstrated that ID bolus infusion was associated with a significantly shorter Tmax with statistically significantly smaller intra-subject variability , compared to SC infusion , and this difference was maintained over three treatment days . Analyses of secondary PK endpoints corresponded with the primary endpoint findings . Postprandial glycemic response was significantly less pronounced after ID bolus : For most endpoints ID vs. SC , differences were statistically significant within the 0-1.5 or 0-2 h time period . Intradermal delivery of insulin is a viable delivery route alternative providing reduced time for insulin absorption with less intra-subject variability and lower glycemic response ."
],
"offsets": [
[
0,
1913
]
]
}
] | [
{
"id": "71643",
"type": "Intervention_Pharmacological",
"text": [
"insulin infusion"
],
"offsets": [
[
12,
28
]
],
"normalized": []
},
{
"id": "71644",
"type": "Intervention_Physical",
"text": [
"intradermal ( ID )"
],
"offsets": [
[
144,
162
]
],
"normalized": []
},
{
"id": "71645",
"type": "Intervention_Physical",
"text": [
"continuous microneedle-based drug infusion"
],
"offsets": [
[
358,
400
]
],
"normalized": []
},
{
"id": "71646",
"type": "Outcome_Physical",
"text": [
"of insulin aspart and blood glucose in serum"
],
"offsets": [
[
1126,
1170
]
],
"normalized": []
},
{
"id": "71647",
"type": "Outcome_Physical",
"text": [
"endpoint insulin Tmax"
],
"offsets": [
[
1185,
1206
]
],
"normalized": []
},
{
"id": "71648",
"type": "Outcome_Physical",
"text": [
"significantly shorter Tmax"
],
"offsets": [
[
1265,
1291
]
],
"normalized": []
},
{
"id": "71649",
"type": "Outcome_Physical",
"text": [
"smaller intra-subject variability"
],
"offsets": [
[
1325,
1358
]
],
"normalized": []
},
{
"id": "71650",
"type": "Outcome_Physical",
"text": [
"secondary PK endpoints"
],
"offsets": [
[
1462,
1484
]
],
"normalized": []
},
{
"id": "71651",
"type": "Outcome_Other",
"text": [
"findings"
],
"offsets": [
[
1524,
1532
]
],
"normalized": []
},
{
"id": "71652",
"type": "Outcome_Physical",
"text": [
"Postprandial glycemic response"
],
"offsets": [
[
1535,
1565
]
],
"normalized": []
},
{
"id": "71653",
"type": "Outcome_Other",
"text": [
"reduced time for insulin absorption"
],
"offsets": [
[
1812,
1847
]
],
"normalized": []
},
{
"id": "71654",
"type": "Outcome_Other",
"text": [
"less intra-subject variability"
],
"offsets": [
[
1853,
1883
]
],
"normalized": []
},
{
"id": "71655",
"type": "Outcome_Mental",
"text": [
"lower glycemic response"
],
"offsets": [
[
1888,
1911
]
],
"normalized": []
},
{
"id": "71656",
"type": "Participant_Condition",
"text": [
"continuous subcutaneous insulin infusion ( CSII"
],
"offsets": [
[
596,
643
]
],
"normalized": []
},
{
"id": "71657",
"type": "Participant_Sample-size",
"text": [
"Twenty-eight"
],
"offsets": [
[
834,
846
]
],
"normalized": []
},
{
"id": "71658",
"type": "Participant_Sample-size",
"text": [
"23"
],
"offsets": [
[
907,
909
]
],
"normalized": []
}
] | [] | [] | [] |
71659 | 26037484 | [
{
"id": "71660",
"type": "document",
"text": [
"The Beyond Ageing Project Phase 2 -- a double-blind , selective prevention , randomised , placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression : study protocol for a randomized controlled trial . BACKGROUND Late-life depression is associated with high rates of morbidity , premature mortality , disability , functional decline , caregiver burden and increased health care costs . While clinical and public health approaches are focused on prevention or early intervention strategies , the ideal method of intervention remains unclear . No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression . METHODS/DESIGN Subjects with previously reported sub-threshold depressive symptoms , aged 60 to 74 years , will be screened to participate in a single-centre , double-blind , randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride , compared with matching placebo . Subjects will be excluded if they have current depression or suicide ideation ; are taking antidepressants or any supplement containing omega-3 fatty acid ; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease , neurological disease , significant psychiatric disease ( other than depression ) or neurodegenerative disease . The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events . At three months , subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes . Additionally , proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions . The trial will be conducted in urban New South Wales , Australia , and will recruit a community-based sample of 450 adults . Using intention-to-treat methods , the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition . DISCUSSION The current health , social and economic costs of late-life depression make prevention imperative from a public health perspective . This innovative trial aims to address the long-neglected area of prevention of depression in older adults . The interventions are targeted to the pathophysiology of disease , and regardless of the effect size of treatment , the outcomes will offer major scientific advances regarding the neurobiological action of these agents . The main results are expected to be available in 2017 . TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 ( 12 January 2010 ) ."
],
"offsets": [
[
0,
2839
]
]
}
] | [
{
"id": "71661",
"type": "Intervention_Pharmacological",
"text": [
"omega-3 fatty acids"
],
"offsets": [
[
118,
137
]
],
"normalized": []
},
{
"id": "71662",
"type": "Intervention_Pharmacological",
"text": [
"sertraline"
],
"offsets": [
[
142,
152
]
],
"normalized": []
},
{
"id": "71663",
"type": "Intervention_Pharmacological",
"text": [
"omega-3 fatty acid supplementation"
],
"offsets": [
[
979,
1013
]
],
"normalized": []
},
{
"id": "71664",
"type": "Intervention_Pharmacological",
"text": [
"sertraline hydrochloride"
],
"offsets": [
[
1017,
1041
]
],
"normalized": []
},
{
"id": "71665",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
90,
97
]
],
"normalized": []
},
{
"id": "71666",
"type": "Outcome_Mortality",
"text": [
"morbidity"
],
"offsets": [
[
317,
326
]
],
"normalized": []
},
{
"id": "71667",
"type": "Outcome_Mortality",
"text": [
"premature mortality"
],
"offsets": [
[
329,
348
]
],
"normalized": []
},
{
"id": "71668",
"type": "Outcome_Physical",
"text": [
"disability , functional decline"
],
"offsets": [
[
351,
382
]
],
"normalized": []
},
{
"id": "71669",
"type": "Outcome_Other",
"text": [
"caregiver burden"
],
"offsets": [
[
385,
401
]
],
"normalized": []
},
{
"id": "71670",
"type": "Outcome_Other",
"text": [
"health care costs"
],
"offsets": [
[
416,
433
]
],
"normalized": []
},
{
"id": "71671",
"type": "Outcome_Other",
"text": [
"structural neuroimaging"
],
"offsets": [
[
1606,
1629
]
],
"normalized": []
},
{
"id": "71672",
"type": "Outcome_Other",
"text": [
"proton spectroscopy"
],
"offsets": [
[
1735,
1754
]
],
"normalized": []
},
{
"id": "71673",
"type": "Outcome_Other",
"text": [
"brain-imaging markers"
],
"offsets": [
[
1790,
1811
]
],
"normalized": []
},
{
"id": "71674",
"type": "Outcome_Physical",
"text": [
"health"
],
"offsets": [
[
416,
422
]
],
"normalized": []
},
{
"id": "71675",
"type": "Outcome_Other",
"text": [
"social and economic costs"
],
"offsets": [
[
2230,
2255
]
],
"normalized": []
}
] | [] | [] | [] |
71676 | 26040302 | [
{
"id": "71677",
"type": "document",
"text": [
"Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin : a 78-week randomized , double-blind , placebo-controlled trial . AIMS To investigate the efficacy and tolerability of empagliflozin added to basal insulin-treated type 2 diabetes . METHODS Patients inadequately controlled [ glycated haemoglobin ( HbA1c ) > 7 to ≤10 % ( > 53 to ≤86 mmol/mol ) ] on basal insulin ( glargine , detemir , NPH ) were randomized to empagliflozin 10 mg ( n = 169 ) , empagliflozin 25 mg ( n = 155 ) or placebo ( n = 170 ) for 78 weeks . The baseline characteristics were balanced among the groups [ mean HbA1c 8.2 % ( 67 mmol/mol ) , BMI 32.2 kg/m ( 2 ) ] . The basal insulin dose was to remain constant for 18 weeks , then could be adjusted at investigator 's discretion . The primary endpoint was change from baseline in HbA1c at week 18 . Key secondary endpoints were changes from baseline in HbA1c and insulin dose at week 78 . RESULTS At week 18 , the adjusted mean ± standard error changes from baseline in HbA1c were 0.0 ± 0.1 % ( -0.1 ± 0.8 mmol/mol ) for placebo , compared with -0.6 ± 0.1 % ( -6.2 ± 0.8 mmol/mol ) and -0.7 ± 0.1 % ( -7.8 ± 0.8 mmol/mol ) for empagliflozin 10 and 25 mg , respectively ( both p < 0.001 ) . At week 78 , empagliflozin 10 and 25 mg significantly reduced HbA1c , insulin dose and weight vs placebo ( all p < 0.01 ) , and empagliflozin 10 mg significantly reduced systolic blood pressure vs placebo ( p = 0.004 ) . Similar percentages of patients had confirmed hypoglycaemia in all groups ( 35-36 % ) . Events consistent with urinary tract infection were reported in 9 , 15 and 12 % of patients on placebo , empagliflozin 10 and 25 mg , and events consistent with genital infection were reported in 2 , 8 and 5 % , respectively . CONCLUSIONS Empagliflozin for 78 weeks added to basal insulin improved glycaemic control and reduced weight with a similar risk of hypoglycaemia to placebo ."
],
"offsets": [
[
0,
1965
]
]
}
] | [
{
"id": "71678",
"type": "Intervention_Pharmacological",
"text": [
"empagliflozin"
],
"offsets": [
[
10,
23
]
],
"normalized": []
},
{
"id": "71679",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
150,
168
]
],
"normalized": []
},
{
"id": "71680",
"type": "Intervention_Pharmacological",
"text": [
"empagliflozin"
],
"offsets": [
[
10,
23
]
],
"normalized": []
},
{
"id": "71681",
"type": "Intervention_Pharmacological",
"text": [
"empagliflozin"
],
"offsets": [
[
10,
23
]
],
"normalized": []
},
{
"id": "71682",
"type": "Intervention_Pharmacological",
"text": [
"empagliflozin"
],
"offsets": [
[
10,
23
]
],
"normalized": []
},
{
"id": "71683",
"type": "Outcome_Other",
"text": [
"efficacy"
],
"offsets": [
[
201,
209
]
],
"normalized": []
},
{
"id": "71684",
"type": "Outcome_Other",
"text": [
"tolerability"
],
"offsets": [
[
214,
226
]
],
"normalized": []
},
{
"id": "71685",
"type": "Participant_Condition",
"text": [
"type 2 diabetes"
],
"offsets": [
[
53,
68
]
],
"normalized": []
},
{
"id": "71686",
"type": "Participant_Sample-size",
"text": [
"169"
],
"offsets": [
[
498,
501
]
],
"normalized": []
},
{
"id": "71687",
"type": "Participant_Sample-size",
"text": [
"155"
],
"offsets": [
[
532,
535
]
],
"normalized": []
},
{
"id": "71688",
"type": "Participant_Sample-size",
"text": [
"170"
],
"offsets": [
[
555,
558
]
],
"normalized": []
}
] | [] | [] | [] |
71689 | 26046796 | [
{
"id": "71690",
"type": "document",
"text": [
"Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations : a randomized , open-label , prospective trial . OBJECTIVE To analyze the efficacy of gemcitabine with or without erlotinib for pancreatic cancer , and to determine the predictive role of epidermal growth factor receptor ( EGFR ) and KRAS mutations in these patients . METHODS This was a single-center , randomized , open-label , prospective trial . Eighty-eight chemotherapy-naïve metastatic pancreatic cancer patients were randomized for treatment with gemcitabine or gemcitabine plus erlotinib . EGFR and KRAS mutations were analyzed , respectively . The primary endpoint was the disease control rate . RESULTS Disease control rate ( 64 % vs. 25 % ; P < 0.001 ) , progression-free survival ( median 3.8 vs. 2.4 months ; P < 0.001 ) , and overall survival ( median 7.2 vs. 4.4 months ; P < 0.001 ) were better in the gemcitabine plus erlotinib group than in the gemcitabine alone group . In the gemcitabine plus erlotinib group , disease control ( 85 % vs. 33 % ; P = 0.001 ) , progression-free survival ( median 5.9 vs. 2.4 months ; P = 0.004 ) , and overall survival ( median 8.7 vs. 6.0 months ; P = 0.044 ) were better in patients with EGFR mutations than in those without EGFR mutations . KRAS mutation was not associated with treatment response or survival . CONCLUSIONS Gemcitabine plus erlotinib is more effective than gemcitabine alone for treating metastatic pancreatic cancer patients , especially those with EGFR mutations . ClinicalTrials.gov number , NCT01608841 ."
],
"offsets": [
[
0,
1573
]
]
}
] | [
{
"id": "71691",
"type": "Intervention_Pharmacological",
"text": [
"Erlotinib"
],
"offsets": [
[
0,
9
]
],
"normalized": []
},
{
"id": "71692",
"type": "Intervention_Pharmacological",
"text": [
"gemcitabine"
],
"offsets": [
[
179,
190
]
],
"normalized": []
},
{
"id": "71693",
"type": "Intervention_Pharmacological",
"text": [
"erlotinib"
],
"offsets": [
[
207,
216
]
],
"normalized": []
},
{
"id": "71694",
"type": "Outcome_Other",
"text": [
"the disease control rate"
],
"offsets": [
[
672,
696
]
],
"normalized": []
},
{
"id": "71695",
"type": "Outcome_Other",
"text": [
"RESULTS Disease control rate"
],
"offsets": [
[
699,
727
]
],
"normalized": []
},
{
"id": "71696",
"type": "Outcome_Mortality",
"text": [
"progression-free survival"
],
"offsets": [
[
760,
785
]
],
"normalized": []
},
{
"id": "71697",
"type": "Outcome_Mortality",
"text": [
"and overall survival"
],
"offsets": [
[
830,
850
]
],
"normalized": []
},
{
"id": "71698",
"type": "Outcome_Other",
"text": [
"disease control"
],
"offsets": [
[
676,
691
]
],
"normalized": []
},
{
"id": "71699",
"type": "Outcome_Mortality",
"text": [
"progression-free survival"
],
"offsets": [
[
760,
785
]
],
"normalized": []
},
{
"id": "71700",
"type": "Outcome_Mortality",
"text": [
"and overall survival"
],
"offsets": [
[
830,
850
]
],
"normalized": []
},
{
"id": "71701",
"type": "Participant_Condition",
"text": [
"pancreatic cancer with epidermal"
],
"offsets": [
[
26,
58
]
],
"normalized": []
},
{
"id": "71702",
"type": "Participant_Sample-size",
"text": [
"Eighty-eight"
],
"offsets": [
[
443,
455
]
],
"normalized": []
},
{
"id": "71703",
"type": "Participant_Condition",
"text": [
"chemotherapy-naïve metastatic pancreatic cancer patients"
],
"offsets": [
[
456,
512
]
],
"normalized": []
},
{
"id": "71704",
"type": "Participant_Condition",
"text": [
"gemcitabine or gemcitabine plus erlotinib"
],
"offsets": [
[
548,
589
]
],
"normalized": []
},
{
"id": "71705",
"type": "Participant_Condition",
"text": [
"patients with EGFR mutations than in those without EGFR mutations"
],
"offsets": [
[
1221,
1286
]
],
"normalized": []
},
{
"id": "71706",
"type": "Participant_Condition",
"text": [
"treating metastatic pancreatic cancer patients , especially those with EGFR mutations"
],
"offsets": [
[
1444,
1529
]
],
"normalized": []
}
] | [] | [] | [] |
71707 | 26052790 | [
{
"id": "71708",
"type": "document",
"text": [
"Environmental enrichment as a therapy for autism : A clinical trial replication and extension . Based on work done in animal models showing that autism-like symptoms are ameliorated following exposure to an enriched sensorimotor environment , we attempted to develop a comparable therapy for children with autism . In an initial randomized controlled trial , children with autism who received sensorimotor enrichment at home for 6 months had significant improvements in both their cognitive ability and the severity of their autism symptoms ( Woo & Leon , 2013 ) . We now report the outcomes of a similar randomized controlled trial in which children with autism , 3 to 6 years old , were randomly assigned to groups that received either daily sensorimotor enrichment , administered by their parents , along with standard care , or they received standard care alone . After 6 months , enriched children showed statistically significant gains in their IQ scores , a decline in their atypical sensory responses , and an improvement in their receptive language performance , compared to controls . Furthermore , after 6 months of enrichment therapy , 21 % of the children who initially had been given an autism classification , using the Autism Diagnostic Observation Schedule , improved to the point that , although they remained on the autism spectrum , they no longer met the criteria for classic autism . None of the standard care controls reached an equivalent level of improvement . Finally , the outcome measures for children who received only a subset of sensory stimuli were similar to those receiving the full complement of enrichment exercises . Sensorimotor enrichment therapy therefore appears to be a cost-effective means of treating a range of symptoms for children with autism ."
],
"offsets": [
[
0,
1791
]
]
}
] | [
{
"id": "71709",
"type": "Intervention_Educational",
"text": [
"Environmental enrichment"
],
"offsets": [
[
0,
24
]
],
"normalized": []
},
{
"id": "71710",
"type": "Intervention_Educational",
"text": [
"enriched sensorimotor environment"
],
"offsets": [
[
207,
240
]
],
"normalized": []
},
{
"id": "71711",
"type": "Intervention_Educational",
"text": [
"sensorimotor enrichment at home"
],
"offsets": [
[
393,
424
]
],
"normalized": []
},
{
"id": "71712",
"type": "Intervention_Physical",
"text": [
"daily sensorimotor enrichment"
],
"offsets": [
[
738,
767
]
],
"normalized": []
},
{
"id": "71713",
"type": "Intervention_Control",
"text": [
"received standard care alone"
],
"offsets": [
[
837,
865
]
],
"normalized": []
},
{
"id": "71714",
"type": "Outcome_Physical",
"text": [
"IQ scores"
],
"offsets": [
[
951,
960
]
],
"normalized": []
},
{
"id": "71715",
"type": "Outcome_Physical",
"text": [
"atypical sensory responses"
],
"offsets": [
[
982,
1008
]
],
"normalized": []
},
{
"id": "71716",
"type": "Outcome_Mental",
"text": [
"receptive language performance"
],
"offsets": [
[
1039,
1069
]
],
"normalized": []
},
{
"id": "71717",
"type": "Outcome_Physical",
"text": [
"outcome measures"
],
"offsets": [
[
1500,
1516
]
],
"normalized": []
},
{
"id": "71718",
"type": "Outcome_Other",
"text": [
"cost-effective"
],
"offsets": [
[
1712,
1726
]
],
"normalized": []
},
{
"id": "71719",
"type": "Participant_Condition",
"text": [
"autism :"
],
"offsets": [
[
42,
50
]
],
"normalized": []
},
{
"id": "71720",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
42,
48
]
],
"normalized": []
},
{
"id": "71721",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
292,
300
]
],
"normalized": []
},
{
"id": "71722",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
42,
48
]
],
"normalized": []
},
{
"id": "71723",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
42,
48
]
],
"normalized": []
},
{
"id": "71724",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
292,
300
]
],
"normalized": []
},
{
"id": "71725",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
42,
48
]
],
"normalized": []
},
{
"id": "71726",
"type": "Participant_Age",
"text": [
"3 to 6 years old ,"
],
"offsets": [
[
665,
683
]
],
"normalized": []
}
] | [] | [] | [] |
71727 | 26053242 | [
{
"id": "71728",
"type": "document",
"text": [
"Assessment from Functional Perspectives : Using Sensorimotor Control in the Hand as an Outcome Indicator in the Surgical Treatment of Carpal Tunnel Syndrome . To investigate whether sensorimotor control of the hand could be an outcome indicator after carpal tunnel release ( CTR ) , this work examined changes in the results of patients ' manual tactile test ( MTT ) , pinch-holding-up activity ( PHUA ) , two-point discrimination ( 2PD ) and Semmes-Weinstein monofilament ( SWM ) tests . Participants included 30 predominantly sensory neuropathy CTS patients , as confirmed by a nerve conduction study . The MTT , precision pinch performance in PHUA and traditional sensibility ( 2PD and SWM ) tests were used to examine different aspects of sensory status at the time-points of two weeks before operation and one month post-operation , with a single-blind design . The results showed significant improvements in the sensory function as detected by the 2PD and SWM tests ( p < 0.001 ) and sensorimotor function as detected by the MTT ( p < 0.001 ) and PHUA test ( p < 0.05 ) for patients receiving CTR . The responsiveness of the SWM , MTT and PHUA tests ( effect size > 0.5 , p < 0.01 ) are better than that of two-point discrimination test ( effect size < 0.5 , p < 0.001 ) . However , pinch strength saw a decline compared to baseline with a moderate effect sizes ( effect size = 0.7 , p < 0.001 ) . This cohort study found that the MTT and PHUA test can both meet all the statistical criteria with regard to assessing treatment outcomes for patients with CTS . In addition , the results of this work provide clinicians with the information that the sensorimotor functions of the hands , as assessed by MTT and PHUA , are responsive to clinical changes due to CTR ."
],
"offsets": [
[
0,
1769
]
]
}
] | [
{
"id": "71729",
"type": "Intervention_Physical",
"text": [
"Sensorimotor Control in the Hand"
],
"offsets": [
[
48,
80
]
],
"normalized": []
},
{
"id": "71730",
"type": "Intervention_Physical",
"text": [
"sensorimotor control"
],
"offsets": [
[
182,
202
]
],
"normalized": []
},
{
"id": "71731",
"type": "Intervention_Physical",
"text": [
"manual tactile test"
],
"offsets": [
[
339,
358
]
],
"normalized": []
},
{
"id": "71732",
"type": "Intervention_Physical",
"text": [
"pinch-holding-up activity"
],
"offsets": [
[
369,
394
]
],
"normalized": []
},
{
"id": "71733",
"type": "Intervention_Physical",
"text": [
"two-point discrimination"
],
"offsets": [
[
406,
430
]
],
"normalized": []
},
{
"id": "71734",
"type": "Intervention_Physical",
"text": [
"Semmes-Weinstein monofilament"
],
"offsets": [
[
443,
472
]
],
"normalized": []
},
{
"id": "71735",
"type": "Intervention_Physical",
"text": [
"MTT , precision pinch performance in PHUA"
],
"offsets": [
[
609,
650
]
],
"normalized": []
},
{
"id": "71736",
"type": "Intervention_Physical",
"text": [
"traditional sensibility ( 2PD and SWM ) tests"
],
"offsets": [
[
655,
700
]
],
"normalized": []
},
{
"id": "71737",
"type": "Intervention_Physical",
"text": [
"2PD"
],
"offsets": [
[
433,
436
]
],
"normalized": []
},
{
"id": "71738",
"type": "Intervention_Physical",
"text": [
"SWM"
],
"offsets": [
[
475,
478
]
],
"normalized": []
},
{
"id": "71739",
"type": "Intervention_Physical",
"text": [
"MTT"
],
"offsets": [
[
361,
364
]
],
"normalized": []
},
{
"id": "71740",
"type": "Intervention_Physical",
"text": [
"PHUA"
],
"offsets": [
[
397,
401
]
],
"normalized": []
},
{
"id": "71741",
"type": "Intervention_Physical",
"text": [
"SWM"
],
"offsets": [
[
475,
478
]
],
"normalized": []
},
{
"id": "71742",
"type": "Intervention_Physical",
"text": [
"MTT"
],
"offsets": [
[
361,
364
]
],
"normalized": []
},
{
"id": "71743",
"type": "Intervention_Physical",
"text": [
"PHUA"
],
"offsets": [
[
397,
401
]
],
"normalized": []
},
{
"id": "71744",
"type": "Intervention_Physical",
"text": [
"MTT"
],
"offsets": [
[
361,
364
]
],
"normalized": []
},
{
"id": "71745",
"type": "Intervention_Physical",
"text": [
"PHUA"
],
"offsets": [
[
397,
401
]
],
"normalized": []
},
{
"id": "71746",
"type": "Intervention_Physical",
"text": [
"MTT"
],
"offsets": [
[
361,
364
]
],
"normalized": []
},
{
"id": "71747",
"type": "Intervention_Physical",
"text": [
"PHUA"
],
"offsets": [
[
397,
401
]
],
"normalized": []
},
{
"id": "71748",
"type": "Outcome_Physical",
"text": [
"sensorimotor control of the hand"
],
"offsets": [
[
182,
214
]
],
"normalized": []
},
{
"id": "71749",
"type": "Outcome_Physical",
"text": [
"sensory function"
],
"offsets": [
[
918,
934
]
],
"normalized": []
},
{
"id": "71750",
"type": "Outcome_Physical",
"text": [
"sensorimotor function"
],
"offsets": [
[
990,
1011
]
],
"normalized": []
},
{
"id": "71751",
"type": "Outcome_Physical",
"text": [
"pinch strength"
],
"offsets": [
[
1289,
1303
]
],
"normalized": []
},
{
"id": "71752",
"type": "Participant_Condition",
"text": [
"Carpal Tunnel Syndrome"
],
"offsets": [
[
134,
156
]
],
"normalized": []
},
{
"id": "71753",
"type": "Participant_Sample-size",
"text": [
"30"
],
"offsets": [
[
511,
513
]
],
"normalized": []
},
{
"id": "71754",
"type": "Participant_Condition",
"text": [
"CTS"
],
"offsets": [
[
547,
550
]
],
"normalized": []
},
{
"id": "71755",
"type": "Participant_Condition",
"text": [
"nerve conduction study"
],
"offsets": [
[
580,
602
]
],
"normalized": []
},
{
"id": "71756",
"type": "Participant_Condition",
"text": [
"patients with CTS ."
],
"offsets": [
[
1546,
1565
]
],
"normalized": []
}
] | [] | [] | [] |
71757 | 26054177 | [
{
"id": "71758",
"type": "document",
"text": [
"Placebo-controlled clinical trial evaluating 9.5 % hydrogen peroxide high-adhesion whitening strips . OBJECTIVE To evaluate the effectiveness and tolerability of an experimental 9.5 % hydrogen peroxide whitening strip relative to a placebo control over a three-week period . METHODS In this parallel-design , double-blind clinical trial , 54 adult volunteers were randomized to an experimental 9.5 % hydrogen peroxide whitening strip or placebo strip balancing for age and baseline tooth color , and received treatment . Strips were worn on the maxillary arch 30 minutes daily for 20 days . Efficacy was measured objectively as L*a*b* color change from digital images at Days 4 , 7 , 15 , and 21 . RESULTS As early as Day 4 and at all subsequent visits , the 9.5 % strip group experienced significant ( p < 0.004 ) color improvement relative to placebo for b* and L* color parameters . The amount of color improvement increased with continuing peroxide strip use . Mean ± SE between-group differences in Ab* were -0.6 ± 0.16 , -0.8 ± 0.15 , -1.6 ± 0.19 , and -1.9 ± 0.20 at Days 4 , 7 , 15 , and 21 , respectively . Similar results were noted for AL* . Minor tooth sensitivity was the most common adverse event , as reported by 12 % of subjects in the 9.5 % strip group and 11 % of subjects in the placebo group . No subjects discontinued treatment due to an adverse event . CONCLUSION This placebo-controlled clinical trial demonstrated that an experimental 9.5 % hydrogen peroxide strip yielded significant tooth whitening relative to a placebo strip as early as after three days of product use ."
],
"offsets": [
[
0,
1598
]
]
}
] | [
{
"id": "71759",
"type": "Intervention_Control",
"text": [
"Placebo-controlled"
],
"offsets": [
[
0,
18
]
],
"normalized": []
},
{
"id": "71760",
"type": "Intervention_Pharmacological",
"text": [
"hydrogen peroxide high-adhesion whitening strips ."
],
"offsets": [
[
51,
101
]
],
"normalized": []
},
{
"id": "71761",
"type": "Intervention_Pharmacological",
"text": [
"hydrogen peroxide whitening strip"
],
"offsets": [
[
184,
217
]
],
"normalized": []
},
{
"id": "71762",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
232,
239
]
],
"normalized": []
},
{
"id": "71763",
"type": "Intervention_Pharmacological",
"text": [
"9.5 % hydrogen peroxide whitening strip or placebo strip"
],
"offsets": [
[
394,
450
]
],
"normalized": []
},
{
"id": "71764",
"type": "Outcome_Physical",
"text": [
"color improvement"
],
"offsets": [
[
815,
832
]
],
"normalized": []
},
{
"id": "71765",
"type": "Outcome_Physical",
"text": [
"color improvement"
],
"offsets": [
[
815,
832
]
],
"normalized": []
},
{
"id": "71766",
"type": "Outcome_Other",
"text": [
"Mean ± SE"
],
"offsets": [
[
965,
974
]
],
"normalized": []
},
{
"id": "71767",
"type": "Outcome_Other",
"text": [
"AL*"
],
"offsets": [
[
1147,
1150
]
],
"normalized": []
},
{
"id": "71768",
"type": "Outcome_Adverse-effects",
"text": [
"Minor tooth sensitivity"
],
"offsets": [
[
1153,
1176
]
],
"normalized": []
}
] | [] | [] | [] |
71769 | 26058489 | [
{
"id": "71770",
"type": "document",
"text": [
"Pulsed electromagnetic fields for postmenopausal osteoporosis and concomitant lumbar osteoarthritis in southwest China using proximal femur bone mineral density as the primary endpoint : study protocol for a randomized controlled trial . BACKGROUND Osteoporosis ( OP ) and osteoarthritis ( OA ) are prevalent skeletal disorders among postmenopausal women . Coexistence is common especially that of postmenopausal osteoporosis ( PMO ) and lumbar OA . An hypothesis has been raised that OP and OA might share the same pathogenic mechanism , and pulsed electromagnetic fields ( PEMFs ) were reported to have anti-osteoporosis and anti-osteoarthritis properties , but this suggestion was based primarily on biomarker data . Therefore , whether these two effects could take place simultaneously has not yet been investigated . This randomized controlled trial ( RCT ) is designed to explore the effect of PEMFs for PMO and concomitant lumbar OA . METHODS/DESIGN The study will include PMO patients ( postmenopausal women ; aged between 50 and 70 years ; have been postmenopausal for at least 5 years and diagnosed with OP using proximal femur T-score ) with concomitant lumbar OA ( patients with confounding disorders like diabetes , hypertension , hyperlipidemia , and previous fracture history , etcetera , will be excluded ) will be randomly assigned to two arms : PEMFs group and sham PEMFs group . There will be 25 participants in each arm ( 50 in total ) and the outcome assessment , including the primary endpoint ( proximal femur bone mineral density ) , will be performed at 5 weeks , 3 months and 6 months after enrollment . DISCUSSION PMO and lumbar OA are prominent public health problem , especially for postmenopausal women . We hope this RCT will provide scientific evidence to primary care of the postmenopausal women regarding the use of these nonpharmaceutical , noninvasive modalities , PEMFs , in managing PMO and lumbar OA . TRIAL REGISTRATION Chinese Clinical Trial Registry : ChiCTR-TRC-14005156 ( 28 August 2014 ) ."
],
"offsets": [
[
0,
2034
]
]
}
] | [
{
"id": "71771",
"type": "Intervention_Physical",
"text": [
"Pulsed electromagnetic fields"
],
"offsets": [
[
0,
29
]
],
"normalized": []
},
{
"id": "71772",
"type": "Intervention_Physical",
"text": [
"pulsed electromagnetic fields ( PEMFs )"
],
"offsets": [
[
543,
582
]
],
"normalized": []
},
{
"id": "71773",
"type": "Intervention_Physical",
"text": [
"PEMFs"
],
"offsets": [
[
575,
580
]
],
"normalized": []
},
{
"id": "71774",
"type": "Intervention_Physical",
"text": [
"PEMFs"
],
"offsets": [
[
575,
580
]
],
"normalized": []
},
{
"id": "71775",
"type": "Intervention_Control",
"text": [
"sham PEMFs group"
],
"offsets": [
[
1379,
1395
]
],
"normalized": []
},
{
"id": "71776",
"type": "Intervention_Physical",
"text": [
"PEMFs"
],
"offsets": [
[
575,
580
]
],
"normalized": []
},
{
"id": "71777",
"type": "Outcome_Physical",
"text": [
"proximal femur bone mineral density"
],
"offsets": [
[
125,
160
]
],
"normalized": []
},
{
"id": "71778",
"type": "Outcome_Physical",
"text": [
"( proximal femur bone mineral density )"
],
"offsets": [
[
1516,
1555
]
],
"normalized": []
},
{
"id": "71779",
"type": "Participant_Condition",
"text": [
"postmenopausal osteoporosis and concomitant lumbar osteoarthritis in southwest China"
],
"offsets": [
[
34,
118
]
],
"normalized": []
},
{
"id": "71780",
"type": "Participant_Condition",
"text": [
"postmenopausal"
],
"offsets": [
[
34,
48
]
],
"normalized": []
},
{
"id": "71781",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
349,
354
]
],
"normalized": []
},
{
"id": "71782",
"type": "Participant_Age",
"text": [
"aged between 50 and 70 years"
],
"offsets": [
[
1018,
1046
]
],
"normalized": []
},
{
"id": "71783",
"type": "Participant_Condition",
"text": [
"postmenopausal"
],
"offsets": [
[
34,
48
]
],
"normalized": []
},
{
"id": "71784",
"type": "Participant_Condition",
"text": [
"diagnosed with OP using proximal femur T-score ) with concomitant lumbar"
],
"offsets": [
[
1099,
1171
]
],
"normalized": []
},
{
"id": "71785",
"type": "Participant_Sample-size",
"text": [
"25 participants in each arm"
],
"offsets": [
[
1412,
1439
]
],
"normalized": []
},
{
"id": "71786",
"type": "Participant_Sample-size",
"text": [
"50 in total"
],
"offsets": [
[
1442,
1453
]
],
"normalized": []
},
{
"id": "71787",
"type": "Participant_Condition",
"text": [
"postmenopausal"
],
"offsets": [
[
34,
48
]
],
"normalized": []
},
{
"id": "71788",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
349,
354
]
],
"normalized": []
}
] | [] | [] | [] |
71789 | 26068086 | [
{
"id": "71790",
"type": "document",
"text": [
"Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion : Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment ( MIVI-TRUST ) Trials . IMPORTANCE The impact of vitreomacular adhesion ( VMA ) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction ( VMT ) has not yet been documented , to our knowledge . OBJECTIVE To determine the impact of intravitreal ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) during a 6-month follow-up in patients with symptomatic VMA . DESIGN , SETTING , AND PARTICIPANTS Two multicenter , randomized , masked , phase 3 clinical trials ( studies TG-MV-006 [ between December 2008 and April 2010 ] and TG-MV-007 [ between December 2008 and July 2010 ] ) at clinic-based centers in the United States and Europe . A total of 652 patients with symptomatic VMA/VMT , including when associated with a macular hole 400 μm or smaller , were studied . Analysis was by intent-to-treat population and performed in May 2013 . INTERVENTIONS Patients with symptomatic VMA/VMT were randomly assigned ( 2:1 or 3:1 in study TG-MV-006 and study TG-MV-007 , respectively ) to receive a single intravitreal injection of ocriplasmin , 125 μg , or placebo-injected vehicle ( placebo ) . The NEI VFQ-25 was administered at baseline and 6 months following ocriplasmin injection . MAIN OUTCOMES AND MEASURES Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change ( ≥5 points ) in scores . RESULTS Across the 2 studies , 464 patients received ocriplasmin and 188 received placebo . At 6 months , the ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group ( mean change , 3.4 vs 0.7 , respectively ; P = .005 ) . Improvements were also noted in subscale scores , with the following respective mean changes for the ocriplasmin vs placebo groups : vision-related dependency , 1.7 vs -2.1 ( P = .009 ) ; driving difficulty , 2.7 vs -1.5 ( P = .03 ) ; distance vision activities , 4.1 vs 0.8 ( P = .03 ) ; and general vision , 6.1 vs 2.1 ( P = .003 ) . A higher proportion of the ocriplasmin group had a clinically meaningful ( ≥5-point ) improvement in NEI VFQ-25 composite score from baseline than the placebo group ( 36.0 % vs 27.2 % , respectively ; P = .03 ) . Fewer ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group ( 15.0 % vs 24.3 % , respectively ; P = .005 ) . Changes in NEI VFQ-25 composite score and various subscale scores were observed in ocriplasmin-treated patients who achieved VMA resolution at day 28 . CONCLUSIONS AND RELEVANCE Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT . TRIAL REGISTRATION clinicaltrials.gov Identifiers : NCT00781859 and NCT00798317 ."
],
"offsets": [
[
0,
3085
]
]
}
] | [
{
"id": "71791",
"type": "Intervention_Pharmacological",
"text": [
"Ocriplasmin"
],
"offsets": [
[
54,
65
]
],
"normalized": []
},
{
"id": "71792",
"type": "Intervention_Surgical",
"text": [
"vitreomacular adhesion ( VMA )"
],
"offsets": [
[
244,
274
]
],
"normalized": []
},
{
"id": "71793",
"type": "Intervention_Physical",
"text": [
"intravitreal ocriplasmin"
],
"offsets": [
[
458,
482
]
],
"normalized": []
},
{
"id": "71794",
"type": "Intervention_Educational",
"text": [
"( NEI VFQ-25 )"
],
"offsets": [
[
590,
604
]
],
"normalized": []
},
{
"id": "71795",
"type": "Outcome_Physical",
"text": [
"visual function"
],
"offsets": [
[
306,
321
]
],
"normalized": []
},
{
"id": "71796",
"type": "Outcome_Other",
"text": [
"changes between baseline and 6-month follow-up"
],
"offsets": [
[
1519,
1565
]
],
"normalized": []
},
{
"id": "71797",
"type": "Outcome_Physical",
"text": [
"NEI VFQ-25"
],
"offsets": [
[
592,
602
]
],
"normalized": []
},
{
"id": "71798",
"type": "Outcome_Other",
"text": [
"composite and subscale scores"
],
"offsets": [
[
1577,
1606
]
],
"normalized": []
},
{
"id": "71799",
"type": "Outcome_Other",
"text": [
"proportion of patients with a clinically meaningful change ( ≥5 points ) in scores"
],
"offsets": [
[
1615,
1697
]
],
"normalized": []
},
{
"id": "71800",
"type": "Outcome_Other",
"text": [
"greater mean improvements from baseline"
],
"offsets": [
[
1837,
1876
]
],
"normalized": []
},
{
"id": "71801",
"type": "Outcome_Physical",
"text": [
"the"
],
"offsets": [
[
106,
109
]
],
"normalized": []
},
{
"id": "71802",
"type": "Outcome_Other",
"text": [
"NEI VFQ-25 composite score"
],
"offsets": [
[
1884,
1910
]
],
"normalized": []
},
{
"id": "71803",
"type": "Outcome_Other",
"text": [
"subscale"
],
"offsets": [
[
1591,
1599
]
],
"normalized": []
},
{
"id": "71804",
"type": "Outcome_Physical",
"text": [
"NEI"
],
"offsets": [
[
592,
595
]
],
"normalized": []
},
{
"id": "71805",
"type": "Outcome_Other",
"text": [
"meaningful worsening"
],
"offsets": [
[
2592,
2612
]
],
"normalized": []
},
{
"id": "71806",
"type": "Outcome_Physical",
"text": [
"Changes in NEI VFQ-25 composite"
],
"offsets": [
[
2710,
2741
]
],
"normalized": []
},
{
"id": "71807",
"type": "Participant_Condition",
"text": [
"Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion"
],
"offsets": [
[
15,
92
]
],
"normalized": []
},
{
"id": "71808",
"type": "Participant_Condition",
"text": [
"patient-reported visual function in symptomatic VMA/vitreomacular traction ( VMT )"
],
"offsets": [
[
289,
371
]
],
"normalized": []
},
{
"id": "71809",
"type": "Participant_Condition",
"text": [
"patients with symptomatic VMA"
],
"offsets": [
[
635,
664
]
],
"normalized": []
},
{
"id": "71810",
"type": "Participant_Sample-size",
"text": [
"652 patients"
],
"offsets": [
[
953,
965
]
],
"normalized": []
},
{
"id": "71811",
"type": "Participant_Condition",
"text": [
"symptomatic VMA/VMT"
],
"offsets": [
[
971,
990
]
],
"normalized": []
},
{
"id": "71812",
"type": "Participant_Sample-size",
"text": [
"464 patients"
],
"offsets": [
[
1731,
1743
]
],
"normalized": []
},
{
"id": "71813",
"type": "Participant_Sample-size",
"text": [
"188 received"
],
"offsets": [
[
1769,
1781
]
],
"normalized": []
}
] | [] | [] | [] |
71814 | 26068449 | [
{
"id": "71815",
"type": "document",
"text": [
"Self-management education for adults with poorly controlled epilepsy ( SMILE ( UK ) ) : statistical , economic and qualitative analysis plan for a randomised controlled trial . BACKGROUND There is a need to test the effectiveness of new educational interventions for people with poorly controlled epilepsy . The SMILE ( self-management education for adults with poorly controlled epilepsy ) trial evaluates a complex service intervention that involves a 2-day self-management course with the aim of improving quality of life and clinical outcomes . This article describes the statistical , economic , and qualitative analysis plan for the trial . METHODS AND DESIGN SMILE is a pragmatic , parallel design , two-arm , multi-centre randomised controlled superiority trial of a group-based interactive course compared with treatment as usual for people who have experienced two or more seizures in the past 12 months . RESULTS A summary of the objectives and design of the trial are reported as well as the manner in which the data will be summarised and inferentially analysed . This includes the type of modelling that will be employed for each of the primary and secondary outcomes and the methods by which the assumptions of these models will be checked . Strategies are described for handling clustering of outcome data , missing observations , and treatment non-compliance . CONCLUSION This update to the previously published trial protocol provides a description of the trial analysis which is transparent and specified before any outcome data are available . It also provides guidance to those planning the analysis of similar trials . TRIAL REGISTRATION Current Controlled Trials ISRCTN57937389 ; date assigned : 27 March 2013 ."
],
"offsets": [
[
0,
1734
]
]
}
] | [
{
"id": "71816",
"type": "Intervention_Educational",
"text": [
"educational"
],
"offsets": [
[
237,
248
]
],
"normalized": []
},
{
"id": "71817",
"type": "Intervention_Educational",
"text": [
"group-based interactive course"
],
"offsets": [
[
775,
805
]
],
"normalized": []
},
{
"id": "71818",
"type": "Intervention_Control",
"text": [
"treatment as usual"
],
"offsets": [
[
820,
838
]
],
"normalized": []
},
{
"id": "71819",
"type": "Outcome_Other",
"text": [
"the effectiveness of new educational interventions"
],
"offsets": [
[
212,
262
]
],
"normalized": []
},
{
"id": "71820",
"type": "Outcome_Other",
"text": [
"improving quality of life and clinical outcomes"
],
"offsets": [
[
499,
546
]
],
"normalized": []
},
{
"id": "71821",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
30,
36
]
],
"normalized": []
},
{
"id": "71822",
"type": "Participant_Condition",
"text": [
"poorly controlled epilepsy ( SMILE ( UK )"
],
"offsets": [
[
42,
83
]
],
"normalized": []
},
{
"id": "71823",
"type": "Participant_Condition",
"text": [
"SMILE ( self-management education"
],
"offsets": [
[
312,
345
]
],
"normalized": []
},
{
"id": "71824",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
30,
36
]
],
"normalized": []
},
{
"id": "71825",
"type": "Participant_Condition",
"text": [
"poorly controlled epilepsy )"
],
"offsets": [
[
362,
390
]
],
"normalized": []
},
{
"id": "71826",
"type": "Participant_Condition",
"text": [
"SMILE is a pragmatic , parallel design , two-arm , multi-centre randomised controlled superiority trial of a group-based interactive course compared with treatment as usual for people who have experienced two or more seizures in the past 12 months"
],
"offsets": [
[
666,
913
]
],
"normalized": []
}
] | [] | [] | [] |
71827 | 26078323 | [
{
"id": "71828",
"type": "document",
"text": [
"A Randomized , Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed , Bivalent , Whole-Cell Oral Cholera Vaccine in Ethiopia . Killed whole-cell oral cholera vaccine ( OCV ) has been a key component of a comprehensive package including water and sanitation measures for recent cholera epidemics . The vaccine , given in a two-dose regimen , has been evaluated in a large number of human volunteers in India , Vietnam , and Bangladesh , where it has demonstrated safety , immunogenicity , and clinical efficacy . We conducted a double-blind randomized placebo-controlled trial in Ethiopia , where we evaluated the safety and immunogenicity of the vaccine in 216 healthy adults and children . OCV was found to be safe and elicited a robust immunological response against Vibrio cholerae O1 , with 81 % adults and 77 % children demonstrating seroconversion 14 days after the second dose of vaccine . This is the first study to evaluate safety and immunogenicity of the vaccine in a population outside Asia using a placebo-controlled , double-blind , randomized study design ."
],
"offsets": [
[
0,
1095
]
]
}
] | [
{
"id": "71829",
"type": "Intervention_Control",
"text": [
"Placebo-Controlled"
],
"offsets": [
[
15,
33
]
],
"normalized": []
},
{
"id": "71830",
"type": "Intervention_Pharmacological",
"text": [
"Whole-Cell Oral Cholera Vaccine"
],
"offsets": [
[
104,
135
]
],
"normalized": []
},
{
"id": "71831",
"type": "Intervention_Pharmacological",
"text": [
"Killed whole-cell oral cholera vaccine ( OCV )"
],
"offsets": [
[
150,
196
]
],
"normalized": []
},
{
"id": "71832",
"type": "Intervention_Pharmacological",
"text": [
"vaccine"
],
"offsets": [
[
181,
188
]
],
"normalized": []
},
{
"id": "71833",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
574,
592
]
],
"normalized": []
},
{
"id": "71834",
"type": "Intervention_Pharmacological",
"text": [
"vaccine"
],
"offsets": [
[
181,
188
]
],
"normalized": []
},
{
"id": "71835",
"type": "Intervention_Pharmacological",
"text": [
"OCV"
],
"offsets": [
[
191,
194
]
],
"normalized": []
},
{
"id": "71836",
"type": "Intervention_Pharmacological",
"text": [
"vaccine"
],
"offsets": [
[
181,
188
]
],
"normalized": []
},
{
"id": "71837",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
574,
592
]
],
"normalized": []
},
{
"id": "71838",
"type": "Outcome_Other",
"text": [
"safety and immunogenicity"
],
"offsets": [
[
636,
661
]
],
"normalized": []
},
{
"id": "71839",
"type": "Outcome_Physical",
"text": [
"safe and elicited a robust immunological response against Vibrio cholerae O1"
],
"offsets": [
[
734,
810
]
],
"normalized": []
},
{
"id": "71840",
"type": "Outcome_Physical",
"text": [
"seroconversion"
],
"offsets": [
[
862,
876
]
],
"normalized": []
},
{
"id": "71841",
"type": "Participant_Condition",
"text": [
"in Ethiopia"
],
"offsets": [
[
136,
147
]
],
"normalized": []
},
{
"id": "71842",
"type": "Participant_Sample-size",
"text": [
"216"
],
"offsets": [
[
680,
683
]
],
"normalized": []
},
{
"id": "71843",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
692,
698
]
],
"normalized": []
},
{
"id": "71844",
"type": "Participant_Age",
"text": [
"children ."
],
"offsets": [
[
703,
713
]
],
"normalized": []
}
] | [] | [] | [] |
71845 | 2607948 | [
{
"id": "71846",
"type": "document",
"text": [
"Effects of hydraulic circuit training on cardiovascular function . The effect of hydraulic circuit training ( HCT ) on cardiovascular ( CV ) function was assessed in 32 healthy middle-aged males ( X age = 42.2 +/- 2.1 yr ) . Maximal aerobic power ( VO2max ) , with simultaneous measurement of stroke volume ( SV ) and cardiac output ( CO ) , by impedance cardiography , was assessed pre- and post-training . Subjects were randomly assigned to a nonexercising control group , a cycle training group ( cycle ) , or one of the two HCT groups . Training groups participated in a 9 wk program , 3 d.wk-1 . Subjects assigned to HCT exercised on a 9 station circuit , completing 3 circuits.d-1 . Each circuit consisted of three 20 s work intervals at each station with a 1:1 work : rest ratio . One HCT group ( HCTmax ) completed the maximal repetitions possible ( RM ) during each work interval . The other HCT group ( HCTsub ) exercised at 70-85 % of RM . Following training VO2max ( ml.kg-1 min-1 ) was significantly increased in all training groups ( 18.0 , 12.5 , and 11.3 % for cycle , HCTsub , and HCTmax groups , respectively ; P less than 0.05 ) . The increase in VO2max observed in the cycle group was significantly greater than that recorded by the two HCT groups ( P less than 0.05 ) . For all three training groups , the increase in VO2max was associated with increases in SVmax and COmax ( P less than 0.05 for both ) . These findings suggest that both maximal and submaximal HCT programs can elicit improvements in cardiovascular fitness ."
],
"offsets": [
[
0,
1547
]
]
}
] | [
{
"id": "71847",
"type": "Intervention_Control",
"text": [
"nonexercising control group , a cycle training group ( cycle ) , or one of the two HCT groups"
],
"offsets": [
[
445,
538
]
],
"normalized": []
},
{
"id": "71848",
"type": "Intervention_Educational",
"text": [
"Training groups participated in a 9 wk program , 3 d.wk-1"
],
"offsets": [
[
541,
598
]
],
"normalized": []
},
{
"id": "71849",
"type": "Intervention_Physical",
"text": [
"Subjects assigned to HCT exercised on a 9 station circuit , completing 3 circuits.d-1"
],
"offsets": [
[
601,
686
]
],
"normalized": []
},
{
"id": "71850",
"type": "Outcome_Physical",
"text": [
"cardiovascular ( CV ) function"
],
"offsets": [
[
119,
149
]
],
"normalized": []
},
{
"id": "71851",
"type": "Outcome_Physical",
"text": [
"Maximal aerobic power ( VO2max )"
],
"offsets": [
[
225,
257
]
],
"normalized": []
},
{
"id": "71852",
"type": "Outcome_Physical",
"text": [
"simultaneous measurement of stroke volume ( SV )"
],
"offsets": [
[
265,
313
]
],
"normalized": []
},
{
"id": "71853",
"type": "Outcome_Physical",
"text": [
"cardiac output ( CO )"
],
"offsets": [
[
318,
339
]
],
"normalized": []
},
{
"id": "71854",
"type": "Outcome_Other",
"text": [
"impedance cardiography"
],
"offsets": [
[
345,
367
]
],
"normalized": []
},
{
"id": "71855",
"type": "Outcome_Physical",
"text": [
"VO2max"
],
"offsets": [
[
249,
255
]
],
"normalized": []
},
{
"id": "71856",
"type": "Outcome_Physical",
"text": [
"HCTmax groups"
],
"offsets": [
[
1098,
1111
]
],
"normalized": []
},
{
"id": "71857",
"type": "Outcome_Physical",
"text": [
"VO2max"
],
"offsets": [
[
249,
255
]
],
"normalized": []
},
{
"id": "71858",
"type": "Outcome_Physical",
"text": [
"VO2max"
],
"offsets": [
[
249,
255
]
],
"normalized": []
},
{
"id": "71859",
"type": "Outcome_Physical",
"text": [
"SVmax"
],
"offsets": [
[
1379,
1384
]
],
"normalized": []
},
{
"id": "71860",
"type": "Outcome_Physical",
"text": [
"COmax"
],
"offsets": [
[
1389,
1394
]
],
"normalized": []
},
{
"id": "71861",
"type": "Outcome_Physical",
"text": [
"cardiovascular fitness"
],
"offsets": [
[
1523,
1545
]
],
"normalized": []
},
{
"id": "71862",
"type": "Participant_Condition",
"text": [
"cardiovascular function"
],
"offsets": [
[
41,
64
]
],
"normalized": []
},
{
"id": "71863",
"type": "Participant_Sample-size",
"text": [
"32"
],
"offsets": [
[
166,
168
]
],
"normalized": []
},
{
"id": "71864",
"type": "Participant_Sex",
"text": [
"males"
],
"offsets": [
[
189,
194
]
],
"normalized": []
},
{
"id": "71865",
"type": "Participant_Age",
"text": [
"42.2 +/- 2.1 yr"
],
"offsets": [
[
205,
220
]
],
"normalized": []
}
] | [] | [] | [] |
71866 | 26082615 | [
{
"id": "71867",
"type": "document",
"text": [
"Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy . BACKGROUND The study reported here compared the blood pressure ( BP ) -lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide ( HCTZ ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg. METHODS Patients with sitting diastolic blood pressure ( siDBP ) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks . After 4 weeks , the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg . RESULTS Of the 263 randomized patients , 256 patients who had available efficacy data were analyzed . The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 ( 6.88±8.10 mmHg vs 3.38±7.33 , P=0.0008 ) , and the effect persisted at Week 8 ( 8.67±9.39 mmHg vs 5.02±8.27 mmHg , P=0.0023 ) . Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group ( at Week 4 , 10.50±13.76 mmHg vs 5.75±12.18 mmHg , P=0.0069 and , at Week 8 , 13.45±15.15 mmHg vs 6.84±13.57 mmHg , P=0.0007 ) . The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP < 90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group ( 53.6 % vs 39.8 % , P=0.0359 ) . The overall incidence of adverse drug reaction was 11.79 % with no significant difference between the treatment groups . CONCLUSION The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy , and had comparable safety and tolerance to fimasartan monotherapy ."
],
"offsets": [
[
0,
2011
]
]
}
] | [
{
"id": "71868",
"type": "Intervention_Pharmacological",
"text": [
"fimasartan/hydrochlorothiazide combination"
],
"offsets": [
[
12,
54
]
],
"normalized": []
},
{
"id": "71869",
"type": "Intervention_Physical",
"text": [
"fimasartan monotherapy"
],
"offsets": [
[
107,
129
]
],
"normalized": []
},
{
"id": "71870",
"type": "Intervention_Pharmacological",
"text": [
"fimasartan alone"
],
"offsets": [
[
224,
240
]
],
"normalized": []
},
{
"id": "71871",
"type": "Intervention_Pharmacological",
"text": [
"fimasartan/hydrochlorothiazide ( HCTZ ) combination"
],
"offsets": [
[
254,
305
]
],
"normalized": []
},
{
"id": "71872",
"type": "Intervention_Pharmacological",
"text": [
"fimasartan"
],
"offsets": [
[
12,
22
]
],
"normalized": []
},
{
"id": "71873",
"type": "Outcome_Other",
"text": [
"Efficacy"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "71874",
"type": "Outcome_Physical",
"text": [
"blood pressure"
],
"offsets": [
[
180,
194
]
],
"normalized": []
},
{
"id": "71875",
"type": "Outcome_Physical",
"text": [
"sitting diastolic blood pressure ( siDBP )"
],
"offsets": [
[
432,
474
]
],
"normalized": []
},
{
"id": "71876",
"type": "Participant_Condition",
"text": [
"hypertensive patients"
],
"offsets": [
[
58,
79
]
],
"normalized": []
},
{
"id": "71877",
"type": "Participant_Condition",
"text": [
"diastolic blood pressure ( siDBP )"
],
"offsets": [
[
440,
474
]
],
"normalized": []
},
{
"id": "71878",
"type": "Participant_Sample-size",
"text": [
"263"
],
"offsets": [
[
837,
840
]
],
"normalized": []
},
{
"id": "71879",
"type": "Participant_Sample-size",
"text": [
"256"
],
"offsets": [
[
863,
866
]
],
"normalized": []
}
] | [] | [] | [] |
71880 | 26100611 | [
{
"id": "71881",
"type": "document",
"text": [
"The effects of parental components in a trauma-focused cognitive behavioral based therapy for children exposed to interparental violence : study protocol for a randomized controlled trial . BACKGROUND Interparental violence is both common and harmful and impacts children 's lives directly and indirectly . Direct effects refer to affective , behavioral , and cognitive responses to interparental violence and psychosocial adjustment . Indirect effects refer to deteriorated parental availability and parent-child interaction . Standard Trauma Focused Cognitive Behavioral Therapy may be insufficient for children traumatized by exposure to interparental violence , given the pervasive impact of interparental violence on the family system . HORIZON is a trauma focused cognitive behavioral therapy based group program with the added component of a preparatory parenting program aimed at improving parental availability ; and the added component of parent-child sessions to improve parent-child interaction . METHODS/DESIGN This is a multicenter , multi-informant and multi-method randomized clinical trial study with a 2 by 2 factorial experimental design . Participants ( N = 100 ) are children ( 4-12 years ) , and their parents , who have been exposed to interparental violence . The main aim of the study is to test the effects of two parental components as an addition to a trauma focused cognitive behavioral based group therapy for reducing children 's symptoms . Primary outcome measures are posttraumatic stress symptoms , and internalizing and externalizing problems in children . The secondary aim of the study is to test the effect of the two added components on adjustment problems in children and to test whether enhanced effects can be explained by changes in children 's responses towards experienced violence , in parental availability , and in quality of parent-child interaction . To address this secondary aim , the main parameters are observational and questionnaire measures of parental availability , parent-child relationship variables , children 's adjustment problems and children 's responses to interparental violence . Data are collected three times : before and after the program and six months later . Both intention-to-treat and completer analyses will be done . DISCUSSION The current study will enhance our understanding of the efficacy interparental violence-related parental components added to trauma focused cognitive behavioral group program for children who have been exposed to IPV . It will illuminate mechanisms underlying change by considering multiple dimensions of child responses , parenting variables and identify selection criteria for participation in treatment . TRIAL REGISTRATION Netherlands Trial Register NTR4015 . Registered 4th of June , 2013 ."
],
"offsets": [
[
0,
2802
]
]
}
] | [
{
"id": "71882",
"type": "Intervention_Educational",
"text": [
"parental components"
],
"offsets": [
[
15,
34
]
],
"normalized": []
},
{
"id": "71883",
"type": "Intervention_Psychological",
"text": [
"trauma-focused cognitive behavioral based therapy"
],
"offsets": [
[
40,
89
]
],
"normalized": []
},
{
"id": "71884",
"type": "Intervention_Psychological",
"text": [
"Trauma Focused Cognitive Behavioral Therapy"
],
"offsets": [
[
537,
580
]
],
"normalized": []
},
{
"id": "71885",
"type": "Intervention_Psychological",
"text": [
"trauma focused cognitive behavioral therapy"
],
"offsets": [
[
755,
798
]
],
"normalized": []
},
{
"id": "71886",
"type": "Intervention_Educational",
"text": [
"preparatory parenting program"
],
"offsets": [
[
849,
878
]
],
"normalized": []
}
] | [] | [] | [] |
71887 | 26109247 | [
{
"id": "71888",
"type": "document",
"text": [
"A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder : The UCLA PEERS ( ® ) Program . Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder ( ASD ) , yet few evidence-based social skills interventions exist for adults on the spectrum . This replication trial tested the effectiveness of PEERS , a caregiver-assisted social skills program for high-functioning young adults with ASD . Using a randomized controlled design , 22 young adults 18-24 years of age were randomly assigned to a treatment ( n = 12 ) or delayed treatment control ( n = 10 ) group . Results revealed that the treatment group improved significantly in overall social skills , frequency of social engagement , and social skills knowledge , and significantly reduced ASD symptoms related to social responsiveness following PEERS . Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed ."
],
"offsets": [
[
0,
1023
]
]
}
] | [
{
"id": "71889",
"type": "Intervention_Educational",
"text": [
"UCLA PEERS ( ® ) Program"
],
"offsets": [
[
107,
131
]
],
"normalized": []
},
{
"id": "71890",
"type": "Outcome_Mental",
"text": [
"evidence-based social skills"
],
"offsets": [
[
279,
307
]
],
"normalized": []
},
{
"id": "71891",
"type": "Outcome_Other",
"text": [
"the effectiveness"
],
"offsets": [
[
387,
404
]
],
"normalized": []
},
{
"id": "71892",
"type": "Outcome_Mental",
"text": [
"in overall social skills"
],
"offsets": [
[
740,
764
]
],
"normalized": []
},
{
"id": "71893",
"type": "Outcome_Mental",
"text": [
"frequency of social engagement"
],
"offsets": [
[
767,
797
]
],
"normalized": []
},
{
"id": "71894",
"type": "Outcome_Mental",
"text": [
"social skills knowledge"
],
"offsets": [
[
804,
827
]
],
"normalized": []
},
{
"id": "71895",
"type": "Outcome_Mental",
"text": [
"reduced ASD symptoms related to social responsiveness following PEERS ."
],
"offsets": [
[
848,
919
]
],
"normalized": []
},
{
"id": "71896",
"type": "Participant_Age",
"text": [
"Young Adults"
],
"offsets": [
[
58,
70
]
],
"normalized": []
},
{
"id": "71897",
"type": "Participant_Condition",
"text": [
"Autism Spectrum Disorder"
],
"offsets": [
[
76,
100
]
],
"normalized": []
},
{
"id": "71898",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
332,
338
]
],
"normalized": []
},
{
"id": "71899",
"type": "Participant_Condition",
"text": [
"on the spectrum"
],
"offsets": [
[
339,
354
]
],
"normalized": []
},
{
"id": "71900",
"type": "Participant_Condition",
"text": [
"high-functioning"
],
"offsets": [
[
463,
479
]
],
"normalized": []
},
{
"id": "71901",
"type": "Participant_Age",
"text": [
"young adults"
],
"offsets": [
[
480,
492
]
],
"normalized": []
},
{
"id": "71902",
"type": "Participant_Sample-size",
"text": [
"22"
],
"offsets": [
[
543,
545
]
],
"normalized": []
},
{
"id": "71903",
"type": "Participant_Age",
"text": [
"young adults 18-24 years of age"
],
"offsets": [
[
546,
577
]
],
"normalized": []
}
] | [] | [] | [] |
71904 | 26121801 | [
{
"id": "71905",
"type": "document",
"text": [
"[ Effect of Preoperative Oral Rehydration on Onset Time and Recovery Time of Rocuronium ] . BACKGROUND Preoperative oral rehydration solution ( ORS ) prevents hypovolemia . The aim of this study was to compare the effect of intubating dose of rocuronium in patients taking and those not taking preoperative ORS . METHODS Twenty patients , ASA I aged 20-50 years scheduled for elective surgery , were investigated and randomly assigned to two groups : drinking 1,500 ml ORS 6 to 2 hours before anesthesia ( ORS group ) and nothing by mouth from 6 hours before anesthesia ( control group ) . Anesthesia was maintained with propofol and remifentanil , and rocuronium 0.6 mg x kg ( -1 ) was administrated . To evaluate the effect of rocuronium , acceleromyography at the adductor pollicis was performed using 0.1 Hz stimulation . Cardiac index ( CI ) and stroke volume variation ( SVV ) from FloTra/Vigileo , times to 95 % twitch depression as onset time ( OT ) , and times to first twitch re-detection ( TR ) were recorded . RESULTS SVV was significantly lower in ORS group ( P = 0.03 ) , and CI showed no difference . In ORS group , TR was significantly shorter than that of control group ( P=0.002 ) , and OT tended to be prolonged ( 99.0 ± 36.3 s vs. 84.0 ± 37.5 s ) , but not significantly . CONCLUSIONS Preoperative oral rehydration possibly increases circulating blood volume , and shortens the duration of rocuronium effect ."
],
"offsets": [
[
0,
1429
]
]
}
] | [
{
"id": "71906",
"type": "Intervention_Pharmacological",
"text": [
"Preoperative Oral Rehydration"
],
"offsets": [
[
12,
41
]
],
"normalized": []
},
{
"id": "71907",
"type": "Intervention_Pharmacological",
"text": [
"oral rehydration solution ( ORS )"
],
"offsets": [
[
116,
149
]
],
"normalized": []
},
{
"id": "71908",
"type": "Intervention_Pharmacological",
"text": [
"rocuronium"
],
"offsets": [
[
243,
253
]
],
"normalized": []
},
{
"id": "71909",
"type": "Intervention_Pharmacological",
"text": [
"ORS ."
],
"offsets": [
[
307,
312
]
],
"normalized": []
},
{
"id": "71910",
"type": "Intervention_Pharmacological",
"text": [
"ORS"
],
"offsets": [
[
144,
147
]
],
"normalized": []
},
{
"id": "71911",
"type": "Intervention_Pharmacological",
"text": [
"( ORS group )"
],
"offsets": [
[
504,
517
]
],
"normalized": []
},
{
"id": "71912",
"type": "Intervention_Control",
"text": [
"nothing by mouth"
],
"offsets": [
[
522,
538
]
],
"normalized": []
},
{
"id": "71913",
"type": "Intervention_Control",
"text": [
"( control group )"
],
"offsets": [
[
570,
587
]
],
"normalized": []
},
{
"id": "71914",
"type": "Intervention_Pharmacological",
"text": [
"propofol"
],
"offsets": [
[
621,
629
]
],
"normalized": []
},
{
"id": "71915",
"type": "Intervention_Pharmacological",
"text": [
"remifentanil"
],
"offsets": [
[
634,
646
]
],
"normalized": []
},
{
"id": "71916",
"type": "Intervention_Pharmacological",
"text": [
"rocuronium"
],
"offsets": [
[
243,
253
]
],
"normalized": []
},
{
"id": "71917",
"type": "Intervention_Pharmacological",
"text": [
"ORS"
],
"offsets": [
[
144,
147
]
],
"normalized": []
},
{
"id": "71918",
"type": "Intervention_Pharmacological",
"text": [
"ORS"
],
"offsets": [
[
144,
147
]
],
"normalized": []
},
{
"id": "71919",
"type": "Outcome_Physical",
"text": [
"Rehydration"
],
"offsets": [
[
30,
41
]
],
"normalized": []
},
{
"id": "71920",
"type": "Outcome_Physical",
"text": [
"rehydration"
],
"offsets": [
[
121,
132
]
],
"normalized": []
},
{
"id": "71921",
"type": "Outcome_Physical",
"text": [
"hypovolemia ."
],
"offsets": [
[
159,
172
]
],
"normalized": []
},
{
"id": "71922",
"type": "Outcome_Physical",
"text": [
"preoperative ORS"
],
"offsets": [
[
294,
310
]
],
"normalized": []
},
{
"id": "71923",
"type": "Outcome_Physical",
"text": [
"Cardiac index ( CI ) and stroke volume variation ( SVV )"
],
"offsets": [
[
826,
882
]
],
"normalized": []
},
{
"id": "71924",
"type": "Outcome_Other",
"text": [
"depression"
],
"offsets": [
[
926,
936
]
],
"normalized": []
},
{
"id": "71925",
"type": "Outcome_Other",
"text": [
"onset time ( OT )"
],
"offsets": [
[
940,
957
]
],
"normalized": []
},
{
"id": "71926",
"type": "Outcome_Other",
"text": [
"twitch re-detection ( TR )"
],
"offsets": [
[
979,
1005
]
],
"normalized": []
}
] | [] | [] | [] |
71927 | 26122384 | [
{
"id": "71928",
"type": "document",
"text": [
"Risk of anterior cruciate ligament fatigue failure is increased by limited internal femoral rotation during in vitro repeated pivot landings . BACKGROUND A reduced range of hip internal rotation is associated with increased peak anterior cruciate ligament ( ACL ) strain and risk for injury . It is unknown , however , whether limiting the available range of internal femoral rotation increases the susceptibility of the ACL to fatigue failure . HYPOTHESIS Risk of ACL failure is significantly greater in female knee specimens with a limited range of internal femoral rotation , smaller femoral-ACL attachment angle , and smaller tibial eminence volume during repeated in vitro simulated single-leg pivot landings . STUDY DESIGN Controlled laboratory study . METHODS A custom-built testing apparatus was used to simulate repeated single-leg pivot landings with a 4×-body weight impulsive load that induces knee compression , knee flexion , and internal tibial torque in 32 paired human knee specimens from 8 male and 8 female donors . These test loads were applied to each pair of specimens , in one knee with limited internal femoral rotation and in the contralateral knee with femoral rotation resisted by 2 springs to simulate the active hip rotator muscles ' resistance to stretch . The landings were repeated until ACL failure occurred or until a minimum of 100 trials were executed . The angle at which the ACL originates from the femur and the tibial eminence volume were measured on magnetic resonance images . RESULTS The final Cox regression model ( P = .024 ) revealed that range of internal femoral rotation and sex of donor were significant factors in determining risk of ACL fatigue failure . The specimens with limited range of internal femoral rotation had a failure risk 17.1 times higher than did the specimens with free rotation ( P = .016 ) . The female knee specimens had a risk of ACL failure 26.9 times higher than the male specimens ( P = .055 ) . CONCLUSION Limiting the range of internal femoral rotation during repetitive pivot landings increases the risk of an ACL fatigue failure in comparison with free rotation in a cadaveric model . CLINICAL RELEVANCE Screening for restricted internal rotation at the hip in ACL injury prevention programs as well as in individuals with ACL injuries and/or reconstructions is warranted ."
],
"offsets": [
[
0,
2353
]
]
}
] | [
{
"id": "71929",
"type": "Intervention_Educational",
"text": [
"A custom-built testing apparatus"
],
"offsets": [
[
767,
799
]
],
"normalized": []
}
] | [] | [] | [] |
71930 | 26122982 | [
{
"id": "71931",
"type": "document",
"text": [
"Expanding care for perinatal women with depression ( EXPONATE ) : study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care . BACKGROUND Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant . In Nigeria , as in many other low- and-middle-income countries ( LMIC ) , perinatal depression usually goes unrecognized and untreated . The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones . METHODS/STUDY DESIGN A pragmatic two-arm parallel cluster randomized controlled trial was designed . The units of allocation are the primary maternal care clinics . Thirty eligible and consenting clinics were randomized but , due to problems with logistics , 29 eventually participated . Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale ( EPDS score ≥12 ) , absent psychosis or bipolar disorder , and not actively suicidal were recruited into the trial ( N = 686 ) . Midwives in the intervention arm were trained to deliver psychoeducation , problem solving treatment , and parenting skills . Eight weekly sessions were delivered following entry into the study . Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms . Clinical support and supervision , delivered mainly by mobile phone , were provided by general physicians and psychiatrists . Automated text and voice messages , also delivered by mobile phones , were used to facilitate patient compliance with clinic appointments and 'homework ' tasks . Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression . Assessments are undertaken at baseline , 2 months following recruitment into the study and 3 , 6 , 9 and 12 months after childbirth . The primary outcome is recovery from depression ( EPDS < 6 ) at 6 months . Secondary outcomes include measures of disability , parenting skills , maternal attitudes , health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley 's Scales . DISCUSSION To the best of our knowledge , this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa . TRIAL REGISTRATION Trial is registered with the ISRTCN registry at isrtcn.com ; Trial number ISRCTN60041127 . Date of registration is 15/05/2013 ."
],
"offsets": [
[
0,
2826
]
]
}
] | [
{
"id": "71932",
"type": "Intervention_Educational",
"text": [
"intervention package for perinatal depression"
],
"offsets": [
[
121,
166
]
],
"normalized": []
},
{
"id": "71933",
"type": "Outcome_Mental",
"text": [
"depression"
],
"offsets": [
[
40,
50
]
],
"normalized": []
},
{
"id": "71934",
"type": "Outcome_Mental",
"text": [
"perinatal depression"
],
"offsets": [
[
146,
166
]
],
"normalized": []
},
{
"id": "71935",
"type": "Outcome_Mental",
"text": [
"Depression"
],
"offsets": [
[
196,
206
]
],
"normalized": []
},
{
"id": "71936",
"type": "Outcome_Mental",
"text": [
"perinatal depression"
],
"offsets": [
[
146,
166
]
],
"normalized": []
},
{
"id": "71937",
"type": "Outcome_Mental",
"text": [
"perinatal depression"
],
"offsets": [
[
146,
166
]
],
"normalized": []
},
{
"id": "71938",
"type": "Outcome_Physical",
"text": [
"absent psychosis or bipolar disorder"
],
"offsets": [
[
1198,
1234
]
],
"normalized": []
},
{
"id": "71939",
"type": "Outcome_Mental",
"text": [
"depressive symptoms"
],
"offsets": [
[
1598,
1617
]
],
"normalized": []
},
{
"id": "71940",
"type": "Outcome_Mental",
"text": [
"recovery from depression"
],
"offsets": [
[
2232,
2256
]
],
"normalized": []
},
{
"id": "71941",
"type": "Outcome_Physical",
"text": [
"measures of"
],
"offsets": [
[
2311,
2322
]
],
"normalized": []
},
{
"id": "71942",
"type": "Outcome_Mental",
"text": [
"disability"
],
"offsets": [
[
2323,
2333
]
],
"normalized": []
},
{
"id": "71943",
"type": "Outcome_Mental",
"text": [
"parenting skills"
],
"offsets": [
[
1414,
1430
]
],
"normalized": []
},
{
"id": "71944",
"type": "Outcome_Mental",
"text": [
"maternal attitudes"
],
"offsets": [
[
2355,
2373
]
],
"normalized": []
},
{
"id": "71945",
"type": "Outcome_Physical",
"text": [
"health care utilization"
],
"offsets": [
[
2376,
2399
]
],
"normalized": []
},
{
"id": "71946",
"type": "Outcome_Physical",
"text": [
"infant physical and cognitive development"
],
"offsets": [
[
2411,
2452
]
],
"normalized": []
},
{
"id": "71947",
"type": "Outcome_Physical",
"text": [
"the Bayley 's Scales"
],
"offsets": [
[
2484,
2504
]
],
"normalized": []
}
] | [] | [] | [] |
71948 | 26129831 | [
{
"id": "71949",
"type": "document",
"text": [
"The effect of the video game Mindlight on anxiety symptoms in children with an Autism Spectrum Disorder . BACKGROUND In the clinical setting , a large proportion of children with an autism spectrum disorder ( ASD ) experience anxiety symptoms . Because anxiety is an important cause of impairment for children with an ASD , it is necessary that effective anxiety interventions are implemented for these children . Recently , a serious game called Mindlight has been developed that is focused on decreasing anxiety in children . This approach is based on recent research suggesting that video games might be suitable as an intervention vehicle to enhance mental health in children . In the present study it will be investigated whether Mindlight is effective in decreasing ( sub ) clinical anxiety symptoms in children who are diagnosed with an ASD . METHODS/DESIGN The present study involves a randomized controlled trial ( RCT ) with two conditions ( experimental versus control ) , in which it is investigated whether Mindlight is effective in decreasing ( sub ) clinical anxiety symptoms in children with an ASD . For this study , children of 8-16 years old with a diagnosis of an ASD and ( sub ) clinical anxiety symptoms will be randomly assigned to the experimental ( N = 60 ) or the control ( N = 60 ) condition . Children in the experimental condition will play Mindlight for one hour per week , for six consecutive weeks . Children in the control condition will play the puzzle game Triple Town , also for one hour per week and for six consecutive weeks . All children will complete assessments at baseline , post-intervention and 3-months follow-up . Furthermore , parents and teachers will also complete assessments at the same time points . The primary outcome will be child report of anxiety symptoms . Secondary outcomes will be parent report of child anxiety , child/parent report of depressive symptoms , and parent/teacher report of social functioning and behavior problems . DISCUSSION This paper aims to describe a study that will examine the effect of the serious game Mindlight on ( sub ) clinical anxiety symptoms of children with an ASD in the age of 8-16 years old . It is expected that children in the experimental condition will show lower levels of anxiety symptoms at 3-months follow-up , compared to children in the control condition . If Mindlight turns out to be effective , it could be an important contribution to the already existing interventions for anxiety in children with an ASD . Mindlight could then be implemented as an evidence-based treatment for anxiety symptoms in children with an ASD in mental health institutes and special education schools . TRIAL REGISTRATION Dutch Trial Register NTR5069 . Registered 20 April 2015 ."
],
"offsets": [
[
0,
2768
]
]
}
] | [
{
"id": "71950",
"type": "Intervention_Educational",
"text": [
"video game Mindlight"
],
"offsets": [
[
18,
38
]
],
"normalized": []
},
{
"id": "71951",
"type": "Intervention_Educational",
"text": [
"game called Mindlight"
],
"offsets": [
[
435,
456
]
],
"normalized": []
},
{
"id": "71952",
"type": "Intervention_Educational",
"text": [
"video games"
],
"offsets": [
[
586,
597
]
],
"normalized": []
},
{
"id": "71953",
"type": "Intervention_Educational",
"text": [
"Mindlight"
],
"offsets": [
[
29,
38
]
],
"normalized": []
},
{
"id": "71954",
"type": "Intervention_Educational",
"text": [
"Mindlight"
],
"offsets": [
[
29,
38
]
],
"normalized": []
},
{
"id": "71955",
"type": "Intervention_Educational",
"text": [
"play Mindlight"
],
"offsets": [
[
1365,
1379
]
],
"normalized": []
},
{
"id": "71956",
"type": "Intervention_Educational",
"text": [
"puzzle game Triple Town"
],
"offsets": [
[
1480,
1503
]
],
"normalized": []
},
{
"id": "71957",
"type": "Intervention_Educational",
"text": [
"Mindlight"
],
"offsets": [
[
29,
38
]
],
"normalized": []
},
{
"id": "71958",
"type": "Intervention_Educational",
"text": [
"Mindlight"
],
"offsets": [
[
29,
38
]
],
"normalized": []
},
{
"id": "71959",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71960",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71961",
"type": "Outcome_Mental",
"text": [
"clinical anxiety symptoms"
],
"offsets": [
[
780,
805
]
],
"normalized": []
},
{
"id": "71962",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71963",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71964",
"type": "Outcome_Mental",
"text": [
"child report of anxiety symptoms"
],
"offsets": [
[
1781,
1813
]
],
"normalized": []
},
{
"id": "71965",
"type": "Outcome_Mental",
"text": [
"parent report of child anxiety"
],
"offsets": [
[
1843,
1873
]
],
"normalized": []
},
{
"id": "71966",
"type": "Outcome_Mental",
"text": [
"child/parent report of depressive symptoms"
],
"offsets": [
[
1876,
1918
]
],
"normalized": []
},
{
"id": "71967",
"type": "Outcome_Mental",
"text": [
"parent/teacher report of social functioning and behavior problems"
],
"offsets": [
[
1925,
1990
]
],
"normalized": []
},
{
"id": "71968",
"type": "Outcome_Physical",
"text": [
"ASD in the age of 8-16 years old ."
],
"offsets": [
[
2156,
2190
]
],
"normalized": []
},
{
"id": "71969",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71970",
"type": "Outcome_Mental",
"text": [
"anxiety symptoms"
],
"offsets": [
[
42,
58
]
],
"normalized": []
},
{
"id": "71971",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
62,
70
]
],
"normalized": []
},
{
"id": "71972",
"type": "Participant_Condition",
"text": [
"an Autism Spectrum Disorder"
],
"offsets": [
[
76,
103
]
],
"normalized": []
},
{
"id": "71973",
"type": "Participant_Condition",
"text": [
"children with an autism spectrum disorder ( ASD ) experience anxiety symptoms ."
],
"offsets": [
[
165,
244
]
],
"normalized": []
},
{
"id": "71974",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
62,
70
]
],
"normalized": []
},
{
"id": "71975",
"type": "Participant_Condition",
"text": [
"an ASD"
],
"offsets": [
[
315,
321
]
],
"normalized": []
},
{
"id": "71976",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
62,
70
]
],
"normalized": []
},
{
"id": "71977",
"type": "Participant_Condition",
"text": [
"who are diagnosed with an ASD"
],
"offsets": [
[
818,
847
]
],
"normalized": []
},
{
"id": "71978",
"type": "Participant_Age",
"text": [
"children of 8-16 years old"
],
"offsets": [
[
1134,
1160
]
],
"normalized": []
},
{
"id": "71979",
"type": "Participant_Condition",
"text": [
"with an ASD"
],
"offsets": [
[
310,
321
]
],
"normalized": []
}
] | [] | [] | [] |
71980 | 26135372 | [
{
"id": "71981",
"type": "document",
"text": [
"Effects of Combined Resistive Underwater Exercises and Interferential Current Therapy in Patients with Juvenile Idiopathic Arthritis : A Randomized Controlled Trial . OBJECTIVE The objective of this study was to verify the effects of combined resistive underwater exercises and interferential current on the peak torque of the quadriceps and hamstrings and pain levels in patients with juvenile idiopathic arthritis . DESIGN This is a randomized controlled study ; 30 children with polyarticular juvenile idiopathic arthritis were randomly distributed into two groups : the control group ( n = 15 ) received the traditional physical therapy program and the study group ( n = 15 ) received resistive underwater exercises and interferential current therapy . Peak torque of the quadriceps and hamstrings and pain levels were evaluated before treatment , 1 mo later , and after 3 mos using the HUMAC NORM , CSMI Testing and Rehabilitation Isokinetic System and visual analog scale , respectively . RESULTS In the control group , all measures showed significant differences ( P < 0.05 ) after 1 mo except peak torque of left quadriceps and pain levels , and significant differences were found after 3 mos ( P < 0.05 ) in all . In the study group , all measures showed significant differences after 1 and 3 mos ( P < 0.05 ) and there were significant differences between groups after 1 and 3 mos in favor of the study group ( P < 0.05 ) . CONCLUSION The combination of resistive underwater exercises and interferential current therapy is a potentially valuable treatment for patients with juvenile idiopathic arthritis ."
],
"offsets": [
[
0,
1615
]
]
}
] | [
{
"id": "71982",
"type": "Intervention_Physical",
"text": [
"Combined Resistive Underwater Exercises and Interferential Current Therapy"
],
"offsets": [
[
11,
85
]
],
"normalized": []
},
{
"id": "71983",
"type": "Intervention_Physical",
"text": [
"combined resistive underwater exercises and interferential current"
],
"offsets": [
[
234,
300
]
],
"normalized": []
},
{
"id": "71984",
"type": "Intervention_Physical",
"text": [
"traditional physical therapy program"
],
"offsets": [
[
612,
648
]
],
"normalized": []
},
{
"id": "71985",
"type": "Intervention_Physical",
"text": [
"resistive underwater exercises and interferential current therapy ."
],
"offsets": [
[
689,
756
]
],
"normalized": []
},
{
"id": "71986",
"type": "Intervention_Physical",
"text": [
"The combination of resistive underwater exercises and interferential current therapy"
],
"offsets": [
[
1445,
1529
]
],
"normalized": []
},
{
"id": "71987",
"type": "Outcome_Physical",
"text": [
"Effects"
],
"offsets": [
[
0,
7
]
],
"normalized": []
},
{
"id": "71988",
"type": "Outcome_Physical",
"text": [
"effects"
],
"offsets": [
[
223,
230
]
],
"normalized": []
},
{
"id": "71989",
"type": "Outcome_Pain",
"text": [
"Peak torque of the quadriceps and hamstrings and pain levels"
],
"offsets": [
[
757,
817
]
],
"normalized": []
},
{
"id": "71990",
"type": "Outcome_Mental",
"text": [
"measures"
],
"offsets": [
[
1030,
1038
]
],
"normalized": []
},
{
"id": "71991",
"type": "Outcome_Pain",
"text": [
"peak torque of left quadriceps and pain levels"
],
"offsets": [
[
1101,
1147
]
],
"normalized": []
},
{
"id": "71992",
"type": "Participant_Age",
"text": [
"Juvenile"
],
"offsets": [
[
103,
111
]
],
"normalized": []
},
{
"id": "71993",
"type": "Participant_Condition",
"text": [
"Idiopathic Arthritis"
],
"offsets": [
[
112,
132
]
],
"normalized": []
},
{
"id": "71994",
"type": "Participant_Age",
"text": [
"juvenile"
],
"offsets": [
[
386,
394
]
],
"normalized": []
},
{
"id": "71995",
"type": "Participant_Condition",
"text": [
"idiopathic arthritis"
],
"offsets": [
[
395,
415
]
],
"normalized": []
},
{
"id": "71996",
"type": "Participant_Sample-size",
"text": [
"30"
],
"offsets": [
[
465,
467
]
],
"normalized": []
},
{
"id": "71997",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
468,
476
]
],
"normalized": []
},
{
"id": "71998",
"type": "Participant_Condition",
"text": [
"polyarticular juvenile idiopathic arthritis"
],
"offsets": [
[
482,
525
]
],
"normalized": []
},
{
"id": "71999",
"type": "Participant_Age",
"text": [
"juvenile"
],
"offsets": [
[
386,
394
]
],
"normalized": []
},
{
"id": "72000",
"type": "Participant_Condition",
"text": [
"idiopathic arthritis"
],
"offsets": [
[
395,
415
]
],
"normalized": []
}
] | [] | [] | [] |
72001 | 26138912 | [
{
"id": "72002",
"type": "document",
"text": [
"Predicting Overall Survival After Stereotactic Ablative Radiation Therapy in Early-Stage Lung Cancer : Development and External Validation of the Amsterdam Prognostic Model . PURPOSE A prognostic model for 5-year overall survival ( OS ) , consisting of recursive partitioning analysis ( RPA ) and a nomogram , was developed for patients with early-stage non-small cell lung cancer ( ES-NSCLC ) treated with stereotactic ablative radiation therapy ( SABR ) . METHODS AND MATERIALS A primary dataset of 703 ES-NSCLC SABR patients was randomly divided into a training ( 67 % ) and an internal validation ( 33 % ) dataset . In the former group , 21 unique parameters consisting of patient , treatment , and tumor factors were entered into an RPA model to predict OS . Univariate and multivariate models were constructed for RPA-selected factors to evaluate their relationship with OS . A nomogram for OS was constructed based on factors significant in multivariate modeling and validated with calibration plots . Both the RPA and the nomogram were externally validated in independent surgical ( n = 193 ) and SABR ( n = 543 ) datasets . RESULTS RPA identified 2 distinct risk classes based on tumor diameter , age , World Health Organization performance status ( PS ) and Charlson comorbidity index . This RPA had moderate discrimination in SABR datasets ( c-index range : 0.52-0.60 ) but was of limited value in the surgical validation cohort . The nomogram predicting OS included smoking history in addition to RPA-identified factors . In contrast to RPA , validation of the nomogram performed well in internal validation ( r ( 2 ) = 0.97 ) and external SABR ( r ( 2 ) = 0.79 ) and surgical cohorts ( r ( 2 ) = 0.91 ) . CONCLUSIONS The Amsterdam prognostic model is the first externally validated prognostication tool for OS in ES-NSCLC treated with SABR available to individualize patient decision making . The nomogram retained strong performance across surgical and SABR external validation datasets . RPA performance was poor in surgical patients , suggesting that 2 different distinct patient populations are being treated with these 2 effective modalities ."
],
"offsets": [
[
0,
2161
]
]
}
] | [
{
"id": "72003",
"type": "Intervention_Pharmacological",
"text": [
"Stereotactic Ablative Radiation Therapy"
],
"offsets": [
[
34,
73
]
],
"normalized": []
},
{
"id": "72004",
"type": "Intervention_Pharmacological",
"text": [
"stereotactic ablative radiation therapy ( SABR"
],
"offsets": [
[
407,
453
]
],
"normalized": []
},
{
"id": "72005",
"type": "Intervention_Pharmacological",
"text": [
"SABR"
],
"offsets": [
[
449,
453
]
],
"normalized": []
},
{
"id": "72006",
"type": "Outcome_Mortality",
"text": [
"Overall Survival After Stereotactic Ablative Radiation Therapy"
],
"offsets": [
[
11,
73
]
],
"normalized": []
},
{
"id": "72007",
"type": "Outcome_Physical",
"text": [
"patient , treatment , and tumor factors"
],
"offsets": [
[
677,
716
]
],
"normalized": []
},
{
"id": "72008",
"type": "Outcome_Physical",
"text": [
"RPA identified 2 distinct risk classes based on tumor diameter , age , World Health Organization performance status ( PS ) and Charlson comorbidity index ."
],
"offsets": [
[
1141,
1296
]
],
"normalized": []
},
{
"id": "72009",
"type": "Outcome_Physical",
"text": [
"RPA performance"
],
"offsets": [
[
2003,
2018
]
],
"normalized": []
},
{
"id": "72010",
"type": "Participant_Condition",
"text": [
"early-stage non-small cell lung cancer ( ES-NSCLC ) treated with stereotactic ablative radiation therapy ( SABR )"
],
"offsets": [
[
342,
455
]
],
"normalized": []
},
{
"id": "72011",
"type": "Participant_Sample-size",
"text": [
"703"
],
"offsets": [
[
501,
504
]
],
"normalized": []
},
{
"id": "72012",
"type": "Participant_Condition",
"text": [
"ES-NSCLC SABR"
],
"offsets": [
[
505,
518
]
],
"normalized": []
}
] | [] | [] | [] |
72013 | 26139208 | [
{
"id": "72014",
"type": "document",
"text": [
"Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya . OBJECTIVES Herpes simplex virus type 2 ( HSV-2 ) biomarkers are often used in adolescent sub-Saharan HIV prevention studies , but evaluations of test performance and disclosure outcomes are rare in the published literature . Therefore , we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot ( WB ) , the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya . METHODS In 2011 , 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes . We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity ; positive and indeterminate results were WB tested . We developed culturally sensitive protocols for disclosing positive results , and documented psychosocial responses , reports of sexual contact and HSV-2 symptoms . RESULTS 28 adolescents ( 3.3 % ) were identified as HSV-2 seropositive , six as indeterminate . Of these , 22 positive and all indeterminates were WB tested ; 20 and 5 , respectively , were confirmed positive . Most youth reported moderate brief stress after disclosure ; 22 % reported longer and more severe distress . Boys were more likely to be in the latter category . Self-reported virginity was highly inconsistent with WB-confirmed positives . CONCLUSIONS The higher than manufacturer 's cut-off for Kalon ELISA modestly reduced the rate of false-positive test results , but also increased false negatives . Investigators should consider the risk : benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions . TRIAL REGISTRATION NUMBER NCT01501864 ."
],
"offsets": [
[
0,
1892
]
]
}
] | [
{
"id": "72015",
"type": "Intervention_Educational",
"text": [
"western blot"
],
"offsets": [
[
434,
446
]
],
"normalized": []
},
{
"id": "72016",
"type": "Outcome_Mental",
"text": [
"moderate brief stress after disclosure"
],
"offsets": [
[
1300,
1338
]
],
"normalized": []
},
{
"id": "72017",
"type": "Outcome_Mental",
"text": [
"longer and more severe distress"
],
"offsets": [
[
1355,
1386
]
],
"normalized": []
},
{
"id": "72018",
"type": "Outcome_Physical",
"text": [
"Self-reported virginity"
],
"offsets": [
[
1442,
1465
]
],
"normalized": []
},
{
"id": "72019",
"type": "Outcome_Physical",
"text": [
"WB-confirmed positives"
],
"offsets": [
[
1495,
1517
]
],
"normalized": []
},
{
"id": "72020",
"type": "Outcome_Physical",
"text": [
"false-positive test results"
],
"offsets": [
[
1617,
1644
]
],
"normalized": []
},
{
"id": "72021",
"type": "Outcome_Physical",
"text": [
"false negatives"
],
"offsets": [
[
1666,
1681
]
],
"normalized": []
},
{
"id": "72022",
"type": "Participant_Age",
"text": [
"adolescent"
],
"offsets": [
[
66,
76
]
],
"normalized": []
},
{
"id": "72023",
"type": "Participant_Condition",
"text": [
"HIV"
],
"offsets": [
[
77,
80
]
],
"normalized": []
},
{
"id": "72024",
"type": "Participant_Age",
"text": [
"adolescent"
],
"offsets": [
[
66,
76
]
],
"normalized": []
},
{
"id": "72025",
"type": "Participant_Age",
"text": [
"adolescent"
],
"offsets": [
[
66,
76
]
],
"normalized": []
},
{
"id": "72026",
"type": "Participant_Sample-size",
"text": [
"837"
],
"offsets": [
[
653,
656
]
],
"normalized": []
},
{
"id": "72027",
"type": "Participant_Age",
"text": [
"youth"
],
"offsets": [
[
671,
676
]
],
"normalized": []
},
{
"id": "72028",
"type": "Participant_Sample-size",
"text": [
"28"
],
"offsets": [
[
1077,
1079
]
],
"normalized": []
},
{
"id": "72029",
"type": "Participant_Age",
"text": [
"adolescent participants"
],
"offsets": [
[
1795,
1818
]
],
"normalized": []
}
] | [] | [] | [] |
72030 | 26148018 | [
{
"id": "72031",
"type": "document",
"text": [
"Gluten and casein supplementation does not increase symptoms in children with autism spectrum disorder . AIM A gluten- and casein-free diet is often given to children with autism spectrum disorder ( ASD ) . We aimed to determine the effect of gluten and casein supplementation on maladaptive behaviour , gastrointestinal symptom severity and intestinal fatty acids binding protein ( I-FABP ) excretion in children with ASD . METHODS A randomised , controlled , double-blind trial was performed on 74 children with ASD with severe maladaptive behaviour and increased urinary I-FABP . Subjects were randomised to receive gluten-casein or a placebo for seven days . We evaluated maladaptive behaviour before and after supplementation , using I-FABP excretion , the approach withdrawal problem composite subtest of the Pervasive Developmental Disorder Behavior Inventory and the Gastrointestinal Symptom Severity Index . RESULTS The mean approach withdrawal problem composite score was significantly higher before supplementation than after , both in the placebo and in the gluten-casein group . However , the mean difference was not significant and may have been caused by additional therapy . There was no significant difference in gastrointestinal symptoms and urinary I-FABP excretion . CONCLUSION Administrating gluten-casein to children with ASD for one week did not increase maladaptive behaviour , gastrointestinal symptom severity or urinary I-FABP excretion . The effect of prolonged administration or other mechanisms of enterocyte damage in ASD should be explored ."
],
"offsets": [
[
0,
1573
]
]
}
] | [
{
"id": "72032",
"type": "Intervention_Pharmacological",
"text": [
"Gluten and casein supplementation"
],
"offsets": [
[
0,
33
]
],
"normalized": []
},
{
"id": "72033",
"type": "Intervention_Pharmacological",
"text": [
"gluten- and casein-free diet"
],
"offsets": [
[
111,
139
]
],
"normalized": []
},
{
"id": "72034",
"type": "Intervention_Control",
"text": [
"gluten-casein"
],
"offsets": [
[
619,
632
]
],
"normalized": []
},
{
"id": "72035",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
638,
645
]
],
"normalized": []
},
{
"id": "72036",
"type": "Intervention_Pharmacological",
"text": [
"gluten-casein"
],
"offsets": [
[
619,
632
]
],
"normalized": []
},
{
"id": "72037",
"type": "Intervention_Pharmacological",
"text": [
"gluten-casein"
],
"offsets": [
[
619,
632
]
],
"normalized": []
},
{
"id": "72038",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
64,
72
]
],
"normalized": []
},
{
"id": "72039",
"type": "Participant_Condition",
"text": [
"autism spectrum disorder"
],
"offsets": [
[
78,
102
]
],
"normalized": []
},
{
"id": "72040",
"type": "Participant_Sample-size",
"text": [
"74"
],
"offsets": [
[
497,
499
]
],
"normalized": []
},
{
"id": "72041",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
64,
72
]
],
"normalized": []
},
{
"id": "72042",
"type": "Participant_Condition",
"text": [
"maladaptive behaviour"
],
"offsets": [
[
280,
301
]
],
"normalized": []
},
{
"id": "72043",
"type": "Participant_Condition",
"text": [
"urinary I-FABP"
],
"offsets": [
[
566,
580
]
],
"normalized": []
},
{
"id": "72044",
"type": "Participant_Condition",
"text": [
"Subjects were randomised to receive gluten-casein or a placebo for seven days"
],
"offsets": [
[
583,
660
]
],
"normalized": []
}
] | [] | [] | [] |
72045 | 26151440 | [
{
"id": "72046",
"type": "document",
"text": [
"A controlled trial of the SibworkS group program for siblings of children with special needs . Siblings of children with a disability are an at risk group for emotional and behavioral problems . This study evaluated an intervention to promote the emotional and behavioral functioning of siblings of children with disabilities and chronic health conditions . SibworkS is a six-week manual-based , cognitive-behavioral group support program focussed on strengthening siblings ' perceived social support , self-esteem , problem-solving skills , adaptive coping behaviors and positive sibling relationships . Fifty-six children aged 7-12 were allocated to either the SibworkS program ( n=30 ) or waitlist control ( n=26 ) in alternating sequence . The primary outcome was siblings ' emotional and behavioral functioning . Additional outcomes were self-esteem , perceived social support , the sibling relationship and coping behaviors . Siblings were followed-up immediately after the intervention and at 3-months . Siblings participating in the SibworkS intervention were reported to have fewer emotional and behavioral difficulties than siblings in the control group immediately following the intervention and at the 3-month follow-up . Participation in SibworkS was associated with fewer emotional and behavioral difficulties for siblings . Implications for practice and future research include recommendations for improving program participation ."
],
"offsets": [
[
0,
1446
]
]
}
] | [
{
"id": "72047",
"type": "Intervention_Educational",
"text": [
"SibworkS group program"
],
"offsets": [
[
26,
48
]
],
"normalized": []
},
{
"id": "72048",
"type": "Intervention_Educational",
"text": [
"SibworkS"
],
"offsets": [
[
26,
34
]
],
"normalized": []
},
{
"id": "72049",
"type": "Intervention_Educational",
"text": [
"SibworkS program"
],
"offsets": [
[
663,
679
]
],
"normalized": []
},
{
"id": "72050",
"type": "Intervention_Control",
"text": [
"waitlist control"
],
"offsets": [
[
692,
708
]
],
"normalized": []
},
{
"id": "72051",
"type": "Intervention_Educational",
"text": [
"SibworkS"
],
"offsets": [
[
26,
34
]
],
"normalized": []
},
{
"id": "72052",
"type": "Intervention_Educational",
"text": [
"SibworkS"
],
"offsets": [
[
26,
34
]
],
"normalized": []
},
{
"id": "72053",
"type": "Outcome_Mental",
"text": [
"emotional and behavioral functioning ."
],
"offsets": [
[
779,
817
]
],
"normalized": []
},
{
"id": "72054",
"type": "Outcome_Mental",
"text": [
"self-esteem , perceived social support , the sibling relationship and coping behaviors ."
],
"offsets": [
[
843,
931
]
],
"normalized": []
},
{
"id": "72055",
"type": "Outcome_Mental",
"text": [
"emotional and behavioral difficulties"
],
"offsets": [
[
1091,
1128
]
],
"normalized": []
},
{
"id": "72056",
"type": "Participant_Condition",
"text": [
"special needs"
],
"offsets": [
[
79,
92
]
],
"normalized": []
},
{
"id": "72057",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
65,
73
]
],
"normalized": []
},
{
"id": "72058",
"type": "Participant_Condition",
"text": [
"disability"
],
"offsets": [
[
123,
133
]
],
"normalized": []
},
{
"id": "72059",
"type": "Participant_Condition",
"text": [
"disabilities and chronic health conditions"
],
"offsets": [
[
313,
355
]
],
"normalized": []
},
{
"id": "72060",
"type": "Participant_Sample-size",
"text": [
"Fifty-six"
],
"offsets": [
[
605,
614
]
],
"normalized": []
},
{
"id": "72061",
"type": "Participant_Age",
"text": [
"aged 7-12"
],
"offsets": [
[
624,
633
]
],
"normalized": []
}
] | [] | [] | [] |
72062 | 26153884 | [
{
"id": "72063",
"type": "document",
"text": [
"Replacing Non-Active Video Gaming by Active Video Gaming to Prevent Excessive Weight Gain in Adolescents . OBJECTIVE The aim of the current study was to evaluate the effects of and adherence to an active video game promotion intervention on anthropometrics , sedentary screen time and consumption of sugar-sweetened beverages and snacks among non-active video gaming adolescents who primarily were of healthy weight . METHODS We assigned 270 gaming ( i.e . ≥ 2 hours/week non-active video game time ) adolescents randomly to an intervention group ( n = 140 ) ( receiving active video games and encouragement to play ) or a waiting-list control group ( n = 130 ) . BMI-SDS ( SDS = adjusted for mean standard deviation score ) , waist circumference-SDS , hip circumference and sum of skinfolds were measured at baseline , at four and ten months follow-up ( primary outcomes ) . Sedentary screen time , physical activity , consumption of sugar-sweetened beverages and snacks , and process measures ( not at baseline ) were assessed with self-reports at baseline , one , four and ten months follow-up . Multi-level-intention to treat-regression analyses were conducted . RESULTS The control group decreased significantly more than the intervention group on BMI-SDS ( β = 0.074 , 95 % CI : 0.008 ; 0.14 ) , and sum of skinfolds ( β = 3.22 , 95 % CI : 0.27 ; 6.17 ) ( overall effects ) . The intervention group had a significantly higher decrease in self-reported non-active video game time ( β = -1.76 , 95 % CI : -3.20 ; -0.32 ) and total sedentary screen time ( Exp ( β = 0.81 , 95 % CI : 0.74 ; 0.88 ) than the control group ( overall effects ) . The process evaluation showed that 14 % of the adolescents played the Move video games every week ≥ 1 hour/week during the whole intervention period . CONCLUSIONS The active video game intervention did not result in lower values on anthropometrics in a group of 'excessive ' non-active video gamers ( mean ~ 14 hours/week ) who primarily were of healthy weight compared to a control group throughout a ten-month-period . Even some effects in the unexpected direction were found , with the control group showing lower BMI-SDS and skin folds than the intervention group . The intervention did result in less self-reported sedentary screen time , although these results are likely biased by social desirability . TRIAL REGISTRATION Dutch Trial Register NTR3228 ."
],
"offsets": [
[
0,
2404
]
]
}
] | [
{
"id": "72064",
"type": "Intervention_Educational",
"text": [
"Replacing Non-Active Video Gaming by Active Video Gaming"
],
"offsets": [
[
0,
56
]
],
"normalized": []
},
{
"id": "72065",
"type": "Intervention_Educational",
"text": [
"active video game promotion intervention"
],
"offsets": [
[
197,
237
]
],
"normalized": []
},
{
"id": "72066",
"type": "Intervention_Educational",
"text": [
"non-active video gaming"
],
"offsets": [
[
343,
366
]
],
"normalized": []
},
{
"id": "72067",
"type": "Outcome_Other",
"text": [
"130"
],
"offsets": [
[
656,
659
]
],
"normalized": []
},
{
"id": "72068",
"type": "Outcome_Physical",
"text": [
"BMI-SDS"
],
"offsets": [
[
664,
671
]
],
"normalized": []
},
{
"id": "72069",
"type": "Outcome_Physical",
"text": [
"BMI-SDS"
],
"offsets": [
[
664,
671
]
],
"normalized": []
},
{
"id": "72070",
"type": "Outcome_Other",
"text": [
"and sum of skinfolds"
],
"offsets": [
[
771,
791
]
],
"normalized": []
},
{
"id": "72071",
"type": "Outcome_Other",
"text": [
"decrease in self-reported non-active video game time"
],
"offsets": [
[
1432,
1484
]
],
"normalized": []
},
{
"id": "72072",
"type": "Outcome_Physical",
"text": [
"-3.20 ; -0.32 ) and total sedentary screen"
],
"offsets": [
[
1509,
1551
]
],
"normalized": []
},
{
"id": "72073",
"type": "Participant_Condition",
"text": [
"Excessive Weight Gain"
],
"offsets": [
[
68,
89
]
],
"normalized": []
},
{
"id": "72074",
"type": "Participant_Age",
"text": [
"Adolescents ."
],
"offsets": [
[
93,
106
]
],
"normalized": []
},
{
"id": "72075",
"type": "Participant_Age",
"text": [
"adolescents"
],
"offsets": [
[
367,
378
]
],
"normalized": []
},
{
"id": "72076",
"type": "Participant_Sample-size",
"text": [
"270"
],
"offsets": [
[
438,
441
]
],
"normalized": []
},
{
"id": "72077",
"type": "Participant_Age",
"text": [
"adolescents"
],
"offsets": [
[
367,
378
]
],
"normalized": []
},
{
"id": "72078",
"type": "Participant_Sample-size",
"text": [
"n = 140"
],
"offsets": [
[
549,
556
]
],
"normalized": []
},
{
"id": "72079",
"type": "Participant_Sample-size",
"text": [
"130"
],
"offsets": [
[
656,
659
]
],
"normalized": []
},
{
"id": "72080",
"type": "Participant_Age",
"text": [
"showed that 14 % of the adolescents"
],
"offsets": [
[
1668,
1703
]
],
"normalized": []
}
] | [] | [] | [] |
72081 | 26156941 | [
{
"id": "72082",
"type": "document",
"text": [
"Physical exercise at the workplace reduces perceived physical exertion during healthcare work : cluster randomized controlled trial . BACKGROUND High physical exertion during work is a risk factor for musculoskeletal pain and long-term sickness absence . Physical exertion ( RPE ) reflects the balance between physical work demands and physical capacity of the individual . Thus , increasing the physical capacity through physical exercise may decrease physical exertion during work . This study investigates the effect of workplace-based versus home-based physical exercise on physical exertion during work ( WRPE ) among healthcare workers . METHODS 200 female healthcare workers ( age : 42.0 , body mass index : 24.1 , average pain intensity : 3.1 on a scale of 0 to 10 , average WRPE : 3.6 on a scale of 0 to 10 ) from 18 departments at three participating hospitals . Participants were randomly allocated at the cluster level to 10 weeks of : ( 1 ) workplace physical exercise ( WORK ) performed in groups during working hours for 5×10 minutes per week and up to five group-based coaching sessions on motivation for regular physical exercise , or ( 2 ) home-based physical exercise ( HOME ) performed during leisure time for 5×10 minutes per week . Physical exertion was assessed at baseline and at 10-week follow-up . RESULTS 2.2 ( SD : 1.1 ) and 1.0 ( SD : 1.2 ) training sessions were performed per week in WORK and HOME , respectively . Physical exertion was reduced more in WORK than HOME ( p < 0.01 ) . Between-group differences in physical exertion at follow-up ( WORK vs. HOME ) was -0.5 points ( 95 % CI -0.8 to -0.2 ) . Within-group effect size ( Cohen 's d ) in WORK and HOME was 0.43 and 0.13 , respectively . CONCLUSIONS Physical exercise performed at the workplace appears more effective than home-based exercise in reducing physical exertion during daily work tasks in healthcare workers ."
],
"offsets": [
[
0,
1909
]
]
}
] | [
{
"id": "72083",
"type": "Intervention_Physical",
"text": [
"Physical exercise at the workplace"
],
"offsets": [
[
0,
34
]
],
"normalized": []
},
{
"id": "72084",
"type": "Intervention_Physical",
"text": [
"High physical exertion"
],
"offsets": [
[
145,
167
]
],
"normalized": []
},
{
"id": "72085",
"type": "Participant_Sample-size",
"text": [
"200"
],
"offsets": [
[
652,
655
]
],
"normalized": []
},
{
"id": "72086",
"type": "Participant_Sex",
"text": [
"female"
],
"offsets": [
[
656,
662
]
],
"normalized": []
},
{
"id": "72087",
"type": "Participant_Age",
"text": [
"age : 42.0"
],
"offsets": [
[
684,
694
]
],
"normalized": []
}
] | [] | [] | [] |
72088 | 26158622 | [
{
"id": "72089",
"type": "document",
"text": [
"Optimal vaccination program for healthy adults in China . There is still no suitable routine hepatitis B immunization strategy for adults in China . To establish an optimal vaccination schedule for healthy adults , we investigated various schedules in healthy adults . In this randomized 5143 healthy adults received 10 μg hepatitis B vaccine at 0 , 1 and 3 months ( group A ) , 0 , 1 and 6 months ( group B ) , or 0 , 1 and 12 months ( group C ) . Blood samples were collected after 1 month and 12 months after the third dose . The geometric mean titer ( GMT ) , seroconversion rate ( levels of anti-HBs ≥ 10 mIU/mL ) and high response rate ( levels of anti-HBs ≥ 100 mIU/mL ) were assayed . In our study , 2438 healthy adults finished the full vaccination program and follow-up . The seroconversion/sero-protective rate of groups A-C at one and 12 month after administration of the third vaccine dose was 100 % , 99.9 % and 97.9 % verse 64.9 % , 75.7 % and 79.0 % , respectively . GMT for anti-HBs tested in group A to C within 1 or 12 month after the third vaccination was 213.16 , 432.58 and 451.47 mIU/ml verse 22.07 , 46.70 and 56.18 mIU/ml , respectively . There were significant differences of seroconversion/sero-protective rate and GMT among the 3 groups ( p < 0.01 ) . Given the high anti-HBs seroconversion rate and GMT in all 3 groups , a flexible schedule for Hepatitis B vaccine should be recommended to adults , but 0-1-12 schedule is a better choice ."
],
"offsets": [
[
0,
1468
]
]
}
] | [
{
"id": "72090",
"type": "Intervention_Pharmacological",
"text": [
"Optimal vaccination"
],
"offsets": [
[
0,
19
]
],
"normalized": []
},
{
"id": "72091",
"type": "Intervention_Pharmacological",
"text": [
"hepatitis B immunization"
],
"offsets": [
[
93,
117
]
],
"normalized": []
},
{
"id": "72092",
"type": "Intervention_Pharmacological",
"text": [
"optimal vaccination schedule"
],
"offsets": [
[
165,
193
]
],
"normalized": []
},
{
"id": "72093",
"type": "Outcome_Physical",
"text": [
"Optimal vaccination"
],
"offsets": [
[
0,
19
]
],
"normalized": []
},
{
"id": "72094",
"type": "Outcome_Physical",
"text": [
"optimal vaccination schedule"
],
"offsets": [
[
165,
193
]
],
"normalized": []
},
{
"id": "72095",
"type": "Outcome_Physical",
"text": [
"Blood samples"
],
"offsets": [
[
449,
462
]
],
"normalized": []
},
{
"id": "72096",
"type": "Outcome_Physical",
"text": [
"The geometric mean titer ( GMT ) , seroconversion rate ( levels of anti-HBs ≥ 10 mIU/mL ) and high response rate ( levels of anti-HBs ≥ 100 mIU/mL )"
],
"offsets": [
[
529,
677
]
],
"normalized": []
},
{
"id": "72097",
"type": "Outcome_Physical",
"text": [
"The seroconversion/sero-protective"
],
"offsets": [
[
782,
816
]
],
"normalized": []
},
{
"id": "72098",
"type": "Outcome_Other",
"text": [
"respectively"
],
"offsets": [
[
968,
980
]
],
"normalized": []
},
{
"id": "72099",
"type": "Outcome_Physical",
"text": [
"GMT for anti-HBs"
],
"offsets": [
[
983,
999
]
],
"normalized": []
},
{
"id": "72100",
"type": "Outcome_Physical",
"text": [
"differences of seroconversion/sero-protective rate and"
],
"offsets": [
[
1187,
1241
]
],
"normalized": []
},
{
"id": "72101",
"type": "Outcome_Physical",
"text": [
"high anti-HBs seroconversion rate and"
],
"offsets": [
[
1290,
1327
]
],
"normalized": []
},
{
"id": "72102",
"type": "Participant_Condition",
"text": [
"healthy"
],
"offsets": [
[
32,
39
]
],
"normalized": []
},
{
"id": "72103",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
40,
46
]
],
"normalized": []
},
{
"id": "72104",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
40,
46
]
],
"normalized": []
},
{
"id": "72105",
"type": "Participant_Condition",
"text": [
"healthy"
],
"offsets": [
[
32,
39
]
],
"normalized": []
},
{
"id": "72106",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
40,
46
]
],
"normalized": []
},
{
"id": "72107",
"type": "Participant_Condition",
"text": [
"healthy"
],
"offsets": [
[
32,
39
]
],
"normalized": []
},
{
"id": "72108",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
40,
46
]
],
"normalized": []
},
{
"id": "72109",
"type": "Participant_Sample-size",
"text": [
"5143"
],
"offsets": [
[
288,
292
]
],
"normalized": []
},
{
"id": "72110",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
40,
46
]
],
"normalized": []
},
{
"id": "72111",
"type": "Participant_Sample-size",
"text": [
"2438"
],
"offsets": [
[
708,
712
]
],
"normalized": []
}
] | [] | [] | [] |
72112 | 26160997 | [
{
"id": "72113",
"type": "document",
"text": [
"Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly : A Randomized Controlled Study . Transcranial magnetic stimulation ( TMS ) is a noninvasive brain stimulation technique with potential to improve memory . Mild cognitive impairment ( MCI ) , which still lacks a specific therapy , is a clinical syndrome associated with increased risk of dementia . This study aims to assess the effects of high-frequency repetitive TMS ( HF rTMS ) on everyday memory of the elderly with MCI . We conducted a double-blinded randomized sham-controlled trial using rTMS over the left dorsolateral prefrontal cortex ( DLPFC ) . Thirty-four elderly outpatients meeting Petersen 's MCI criteria were randomly assigned to receive 10 sessions of either active TMS or sham , 10 Hz rTMS at 110 % of motor threshold , 2,000 pulses per session . Neuropsychological assessment at baseline , after the last session ( 10th ) and at one-month follow-up , was applied . ANOVA on the primary efficacy measure , the Rivermead Behavioural Memory Test , revealed a significant group-by-time interaction ( p = 0.05 ) , favoring the active group . The improvement was kept after one month . Other neuropsychological tests were heterogeneous . rTMS at 10 Hz enhanced everyday memory in elderly with MCI after 10 sessions . These findings suggest that rTMS might be effective as a therapy for MCI and probably a tool to delay deterioration ."
],
"offsets": [
[
0,
1436
]
]
}
] | [
{
"id": "72114",
"type": "Intervention_Physical",
"text": [
"Transcranial Magnetic Stimulation"
],
"offsets": [
[
0,
33
]
],
"normalized": []
},
{
"id": "72115",
"type": "Intervention_Physical",
"text": [
"Transcranial magnetic stimulation ( TMS )"
],
"offsets": [
[
120,
161
]
],
"normalized": []
},
{
"id": "72116",
"type": "Intervention_Physical",
"text": [
"high-frequency repetitive TMS ( HF rTMS )"
],
"offsets": [
[
426,
467
]
],
"normalized": []
},
{
"id": "72117",
"type": "Intervention_Physical",
"text": [
"rTMS"
],
"offsets": [
[
461,
465
]
],
"normalized": []
},
{
"id": "72118",
"type": "Outcome_Mental",
"text": [
"the Rivermead Behavioural Memory Test"
],
"offsets": [
[
1013,
1050
]
],
"normalized": []
},
{
"id": "72119",
"type": "Outcome_Mental",
"text": [
"rTMS at 10 Hz enhanced everyday memory"
],
"offsets": [
[
1240,
1278
]
],
"normalized": []
},
{
"id": "72120",
"type": "Participant_Condition",
"text": [
"Mild Cognitive Impairment"
],
"offsets": [
[
45,
70
]
],
"normalized": []
},
{
"id": "72121",
"type": "Participant_Condition",
"text": [
"Mild cognitive impairment ( MCI )"
],
"offsets": [
[
242,
275
]
],
"normalized": []
},
{
"id": "72122",
"type": "Participant_Condition",
"text": [
"MCI"
],
"offsets": [
[
270,
273
]
],
"normalized": []
},
{
"id": "72123",
"type": "Participant_Sample-size",
"text": [
"Thirty-four"
],
"offsets": [
[
644,
655
]
],
"normalized": []
},
{
"id": "72124",
"type": "Participant_Age",
"text": [
"elderly"
],
"offsets": [
[
494,
501
]
],
"normalized": []
},
{
"id": "72125",
"type": "Participant_Condition",
"text": [
"MCI"
],
"offsets": [
[
270,
273
]
],
"normalized": []
},
{
"id": "72126",
"type": "Participant_Age",
"text": [
"elderly"
],
"offsets": [
[
494,
501
]
],
"normalized": []
}
] | [] | [] | [] |
72127 | 26166077 | [
{
"id": "72128",
"type": "document",
"text": [
"1H Magnetic Resonance Spectroscopy Predicts Hepatocellular Carcinoma in a Subset of Patients With Liver Cirrhosis : A Randomized Trial . The goal of this study was to investigate the utility of H magnetic resonance spectroscopy ( H-MRS ) to quantify the differences in liver metabolites . Magnetic resonance spectroscopy was used as a means of predicting the probability of developing hepatocellular carcinoma ( HCC ) in patients with liver cirrhosis secondary to chronic hepatitis B.This study included 20 healthy volunteers , 20 patients with liver cirrhosis secondary to chronic hepatitis B ( cirrhosis group ) , and 20 patients with small HCC secondary to cirrhosis liver parenchyma ( HCC group ) . All patients underwent routine MRI and H-MRS scanning . LCModel software was used to quantify Cho ( Choline ) , Lip ( lipid ) , and Cho/Lip in the 3 groups , and a one-way ANOVA was used to compare the differences in these metabolites between groups.Choline levels were significantly different between the control and HCC group and between the cirrhosis group and the HCC group ( all P < 0.001 ) . There was also a significant difference in Lip levels between the control and cirrhosis group and the control and HCC groups ( all P < 0.001 ) . There were also differences in Cho/Lip between the control and cirrhosis groups , the control and HCC groups , and the cirrhosis and HCC groups ( all P < 0.001 ) .H-MRS followed by the analysis with LCModel can be used to measure changes in hepatic metabolite levels in patients with liver cirrhosis secondary to chronic hepatitis B and HCC . Thus , H-MRS may be helpful in monitoring HCC and liver cirrhosis development ."
],
"offsets": [
[
0,
1668
]
]
}
] | [
{
"id": "72129",
"type": "Intervention_Physical",
"text": [
"H magnetic resonance spectroscopy ( H-MRS )"
],
"offsets": [
[
194,
237
]
],
"normalized": []
},
{
"id": "72130",
"type": "Intervention_Physical",
"text": [
"routine MRI and H-MRS scanning"
],
"offsets": [
[
726,
756
]
],
"normalized": []
},
{
"id": "72131",
"type": "Outcome_Other",
"text": [
"quantify Cho ( Choline )"
],
"offsets": [
[
788,
812
]
],
"normalized": []
},
{
"id": "72132",
"type": "Outcome_Other",
"text": [
"Lip ( lipid )"
],
"offsets": [
[
815,
828
]
],
"normalized": []
},
{
"id": "72133",
"type": "Outcome_Other",
"text": [
"Cho/Lip"
],
"offsets": [
[
835,
842
]
],
"normalized": []
},
{
"id": "72134",
"type": "Outcome_Other",
"text": [
"ANOVA"
],
"offsets": [
[
875,
880
]
],
"normalized": []
},
{
"id": "72135",
"type": "Outcome_Other",
"text": [
"significant difference in Lip levels"
],
"offsets": [
[
1118,
1154
]
],
"normalized": []
},
{
"id": "72136",
"type": "Outcome_Other",
"text": [
"differences in"
],
"offsets": [
[
254,
268
]
],
"normalized": []
},
{
"id": "72137",
"type": "Outcome_Other",
"text": [
"measure changes in hepatic metabolite"
],
"offsets": [
[
1468,
1505
]
],
"normalized": []
}
] | [] | [] | [] |
72138 | 26173631 | [
{
"id": "72139",
"type": "document",
"text": [
"Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection . This study aims to identify patient characteristics that predict effective eltrombopag dosage for the treatment of Hepatitis C virus ( HCV ) -related thrombocytopenia . Demographic , clinical and genetic data collected from thrombocytopenic patients ( n = 1463 , age ≥ 18 years ) with chronic HCV infection who were able to achieve a target platelet count of > 90 × 10 ( 9 ) /L following eltrombopag treatment . Patients were categorized into four groups ( 25 , 50 , 75 , and 100 mg ) based on the eltrombopag dose needed to achieve the target platelet count . Eltrombopag dose predictors were identified using a two stage approach . First , bivariate analysis , using anova for continuous variables and Chi-square test for categorical variables , was performed to identify possible predictors of eltrombopag dose ( P < 0.05 ) . Second , ordinal logistic regression with stepwise addition followed by backward deletion was then performed using predictors identified in bivariate analysis step to produce final model containing independent predictors at P < 0.05 . Ordinal logistic model identified several predictors of eltrombopag dose . Predictors of higher eltrombopag dose include : having a HCV genotype 2 or 3 , being Central/South Asian , being White ( Caucasian or European heritage ) , increased weight , and increased spleen length . Predictors of lower eltrombopag dose include : female gender , increased age , having a higher ALP plasma concentration , increased creatinine clearance , increased baseline lymphocytes count , and increased baseline platelet count . In conclusion , this study identified patient characteristics that predict effective eltrombopag dose for the treatment of HCV-related thrombocytopenia . Early selection of the optimal eltrombopag dose expedites the initiation of antiviral therapy . This is expected to improve the antiviral therapy outcome before the patient progress into liver decompensation ."
],
"offsets": [
[
0,
2033
]
]
}
] | [
{
"id": "72140",
"type": "Outcome_Physical",
"text": [
"include : having a HCV genotype 2 or 3 , being Central/South Asian , being White ( Caucasian or European heritage ) , increased weight , and increased spleen length"
],
"offsets": [
[
1269,
1433
]
],
"normalized": []
},
{
"id": "72141",
"type": "Outcome_Physical",
"text": [
"include : female gender , increased age , having a higher ALP plasma concentration , increased creatinine clearance , increased baseline lymphocytes count , and increased baseline platelet count"
],
"offsets": [
[
1473,
1667
]
],
"normalized": []
},
{
"id": "72142",
"type": "Participant_Condition",
"text": [
"thrombocytopenic subjects with hepatitis C virus infection"
],
"offsets": [
[
31,
89
]
],
"normalized": []
},
{
"id": "72143",
"type": "Participant_Condition",
"text": [
"thrombocytopenic"
],
"offsets": [
[
31,
47
]
],
"normalized": []
},
{
"id": "72144",
"type": "Participant_Sample-size",
"text": [
"n = 1463"
],
"offsets": [
[
344,
352
]
],
"normalized": []
},
{
"id": "72145",
"type": "Participant_Age",
"text": [
"age ≥ 18 years"
],
"offsets": [
[
355,
369
]
],
"normalized": []
},
{
"id": "72146",
"type": "Participant_Condition",
"text": [
"HCV infection"
],
"offsets": [
[
385,
398
]
],
"normalized": []
}
] | [] | [] | [] |
72147 | 26181707 | [
{
"id": "72148",
"type": "document",
"text": [
"Brief Report : Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate : Week 144 Results . BACKGROUND Cobicistat ( COBI ) is a pharmacoenhancer with no antiretroviral activity . METHODS International , randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir ( RTV ) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144 . RESULTS At Week 144 , virologic suppression was achieved in 72 % ( COBI ) and 74 % ( RTV ) of patients . Adverse events leading to study drug discontinuation occurred in 11 % of patients in each group . Median changes in serum creatinine ( mg/dL ) were +0.13 ( COBI ) and +0.07 ( RTV ) and were unchanged from week 48 . CONCLUSIONS Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir ."
],
"offsets": [
[
0,
983
]
]
}
] | [
{
"id": "72149",
"type": "Intervention_Pharmacological",
"text": [
"Cobicistat"
],
"offsets": [
[
15,
25
]
],
"normalized": []
},
{
"id": "72150",
"type": "Intervention_Pharmacological",
"text": [
"Ritonavir"
],
"offsets": [
[
40,
49
]
],
"normalized": []
},
{
"id": "72151",
"type": "Intervention_Pharmacological",
"text": [
"Atazanavir"
],
"offsets": [
[
76,
86
]
],
"normalized": []
},
{
"id": "72152",
"type": "Intervention_Pharmacological",
"text": [
"Combination With Emtricitabine/Tenofovir Disoproxil Fumarate"
],
"offsets": [
[
90,
150
]
],
"normalized": []
},
{
"id": "72153",
"type": "Intervention_Pharmacological",
"text": [
"Cobicistat"
],
"offsets": [
[
15,
25
]
],
"normalized": []
},
{
"id": "72154",
"type": "Intervention_Pharmacological",
"text": [
"COBI"
],
"offsets": [
[
196,
200
]
],
"normalized": []
},
{
"id": "72155",
"type": "Intervention_Pharmacological",
"text": [
"ritonavir ( RTV )"
],
"offsets": [
[
378,
395
]
],
"normalized": []
},
{
"id": "72156",
"type": "Intervention_Pharmacological",
"text": [
"atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate"
],
"offsets": [
[
421,
495
]
],
"normalized": []
},
{
"id": "72157",
"type": "Intervention_Pharmacological",
"text": [
"COBI"
],
"offsets": [
[
196,
200
]
],
"normalized": []
},
{
"id": "72158",
"type": "Intervention_Pharmacological",
"text": [
"RTV"
],
"offsets": [
[
390,
393
]
],
"normalized": []
},
{
"id": "72159",
"type": "Intervention_Pharmacological",
"text": [
"COBI"
],
"offsets": [
[
196,
200
]
],
"normalized": []
},
{
"id": "72160",
"type": "Outcome_Other",
"text": [
"efficacy and safety"
],
"offsets": [
[
347,
366
]
],
"normalized": []
},
{
"id": "72161",
"type": "Outcome_Physical",
"text": [
"virologic suppression"
],
"offsets": [
[
578,
599
]
],
"normalized": []
},
{
"id": "72162",
"type": "Outcome_Adverse-effects",
"text": [
"Adverse events"
],
"offsets": [
[
661,
675
]
],
"normalized": []
},
{
"id": "72163",
"type": "Outcome_Physical",
"text": [
"changes in serum creatinine"
],
"offsets": [
[
766,
793
]
],
"normalized": []
},
{
"id": "72164",
"type": "Participant_Condition",
"text": [
"HIV treatment-naive patients"
],
"offsets": [
[
499,
527
]
],
"normalized": []
}
] | [] | [] | [] |
72165 | 26204331 | [
{
"id": "72166",
"type": "document",
"text": [
"A Double-Blind Placebo-Controlled Study of the Effects of Olprinone , a Specific Phosphodiesterase III Inhibitor , for Preventing Postoperative Atrial Fibrillation in Patients Undergoing Pulmonary Resection for Lung Cancer . BACKGROUND We previously reported that patients with elevated preoperative B-type natriuretic peptide ( BNP ) levels have an increased risk for postoperative atrial fibrillation following lung cancer surgery . The present study evaluated whether the specific phosphodiesterase III inhibitor olprinone can reduce the incidence of postoperative atrial fibrillation in patients with elevated BNP levels undergoing pulmonary resection for lung cancer . METHODS A prospective randomized study was conducted with 40 patients who had elevated preoperative BNP levels ( ≥ 30 pg/mL ) and underwent scheduled lung cancer surgery . All patients were in sinus rhythm at surgery . Low-dose olprinone or placebo was continuously infused for 24 h and started just before anesthesia induction . The primary end point was the incidence of postoperative atrial fibrillation . The secondary end points were perioperative hemodynamics and levels of BNP , WBC counts , and C-reactive protein . RESULTS The incidence of postoperative atrial fibrillation was significantly lower in the olprinone group than in the placebo group ( 10 % vs 60 % , P < .001 ) . Patients in the olprinone group showed significantly lower BNP , WBC counts , and C-reactive protein levels after surgery . CONCLUSIONS Continuous infusion of olprinone during lung cancer surgery was safe and reduced the incidence of postoperative atrial fibrillation following pulmonary resection in patients with elevated preoperative BNP levels . TRIAL REGISTRY Japan Primary Registries Network ; No . : JPRN-UMIN2404 ; URL : http : //www.umin.ac.jp/ctr/ ."
],
"offsets": [
[
0,
1819
]
]
}
] | [
{
"id": "72167",
"type": "Intervention_Control",
"text": [
"Placebo-Controlled"
],
"offsets": [
[
15,
33
]
],
"normalized": []
},
{
"id": "72168",
"type": "Intervention_Pharmacological",
"text": [
"Olprinone"
],
"offsets": [
[
58,
67
]
],
"normalized": []
},
{
"id": "72169",
"type": "Intervention_Pharmacological",
"text": [
"olprinone"
],
"offsets": [
[
516,
525
]
],
"normalized": []
}
] | [] | [] | [] |
72170 | 26205311 | [
{
"id": "72171",
"type": "document",
"text": [
"Multiorgan protection of remote ischemic perconditioning in valve replacement surgery . BACKGROUND Remote ischemic perconditioning ( RIPerc ) is a new alternative of remote ischemic conditioning and has not been well studied . RIPerc attenuates myocardial injury when applied during cardiac surgery . However , its protective effects on other organs remain unknown . MATERIALS AND METHODS Patients with rheumatic heart disease undergoing valve replacement surgery were randomized into the RIPerc group ( n = 101 ) or the control group ( n = 100 ) . RIPerc was achieved by three cycles of 5-min ischemia-5-min reperfusion in the right thigh during surgery . Clinical data and the levels of injury biomarkers for the heart , lungs , liver , and kidneys within 48 h after surgery were compared using one-way or repeated measurement analysis of variance . RESULTS In the RIPerc group , the release of serum cardiac troponin I ( 128.68 ± 102.56 versus 172.33 ± 184.38 , P = 0.04 ) and the inotropic score ( 96.4 ± 73.8 versus 121.5 ± 89.6 , P = 0.032 ) decreased compared with that of the control ; postoperative drainage ( 458.2 ± 264.2 versus 545.1 ± 349.0 ml , P = 0.048 ) and the incidence of acute lung injury was reduced ( 36.6 % versus 51 % , P = 0.04 ) , and the extent of hyperbilirubinemia was also attenuated . No significant difference was observed in the levels of biomarkers for renal injury and systemic inflammation response . CONCLUSIONS RIPerc applied during the valve replacement surgery induced multiple beneficial effects postoperatively including reduced drainage and myocardial damage , lower incidence of acute lung injury , and attenuated hyperbilirubinemia ."
],
"offsets": [
[
0,
1679
]
]
}
] | [
{
"id": "72172",
"type": "Intervention_Surgical",
"text": [
"remote ischemic perconditioning"
],
"offsets": [
[
25,
56
]
],
"normalized": []
},
{
"id": "72173",
"type": "Intervention_Surgical",
"text": [
"Remote ischemic perconditioning ( RIPerc"
],
"offsets": [
[
99,
139
]
],
"normalized": []
},
{
"id": "72174",
"type": "Intervention_Surgical",
"text": [
"RIPerc"
],
"offsets": [
[
133,
139
]
],
"normalized": []
},
{
"id": "72175",
"type": "Intervention_Control",
"text": [
"control"
],
"offsets": [
[
521,
528
]
],
"normalized": []
},
{
"id": "72176",
"type": "Outcome_Physical",
"text": [
"surgery . Clinical data"
],
"offsets": [
[
647,
670
]
],
"normalized": []
},
{
"id": "72177",
"type": "Outcome_Physical",
"text": [
"the levels of injury biomarkers for the heart , lungs , liver , and kidneys"
],
"offsets": [
[
675,
750
]
],
"normalized": []
},
{
"id": "72178",
"type": "Outcome_Physical",
"text": [
"the release of serum cardiac troponin"
],
"offsets": [
[
882,
919
]
],
"normalized": []
},
{
"id": "72179",
"type": "Outcome_Other",
"text": [
"P = 0.04 )"
],
"offsets": [
[
965,
975
]
],
"normalized": []
},
{
"id": "72180",
"type": "Outcome_Other",
"text": [
"the inotropic"
],
"offsets": [
[
980,
993
]
],
"normalized": []
},
{
"id": "72181",
"type": "Outcome_Other",
"text": [
"that of the control ; postoperative"
],
"offsets": [
[
1072,
1107
]
],
"normalized": []
},
{
"id": "72182",
"type": "Outcome_Physical",
"text": [
"545.1 ± 349.0 ml , P = 0.048 )"
],
"offsets": [
[
1140,
1170
]
],
"normalized": []
},
{
"id": "72183",
"type": "Outcome_Adverse-effects",
"text": [
"the incidence"
],
"offsets": [
[
1175,
1188
]
],
"normalized": []
},
{
"id": "72184",
"type": "Outcome_Other",
"text": [
"P = 0.04 )"
],
"offsets": [
[
965,
975
]
],
"normalized": []
},
{
"id": "72185",
"type": "Outcome_Physical",
"text": [
"difference was observed in the levels of biomarkers for renal injury and"
],
"offsets": [
[
1332,
1404
]
],
"normalized": []
},
{
"id": "72186",
"type": "Outcome_Physical",
"text": [
"valve replacement surgery induced multiple beneficial effects postoperatively including reduced drainage and myocardial damage , lower incidence of acute lung injury , and"
],
"offsets": [
[
1476,
1647
]
],
"normalized": []
},
{
"id": "72187",
"type": "Participant_Condition",
"text": [
"valve replacement surgery ."
],
"offsets": [
[
60,
87
]
],
"normalized": []
},
{
"id": "72188",
"type": "Participant_Condition",
"text": [
"Patients with rheumatic heart disease undergoing valve replacement surgery"
],
"offsets": [
[
389,
463
]
],
"normalized": []
}
] | [] | [] | [] |
72189 | 26208985 | [
{
"id": "72190",
"type": "document",
"text": [
"A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone : Effects on aberrant behavior in children with autism . To assess the safety and efficacy of pioglitazone added to risperidone in the treatment of irritability in autistic disorder ( AD ) , we conducted this study . In a 10-week , randomized , double-blind , parallel-group , placebo-controlled clinical trial , 44 outpatients of both genders aged 4-12 years with a diagnosis of AD and a score of ≥12 on the Aberrant Behavior Checklist-Community ( ABC-C ) irritability subscale were included . Mean change of ABC-C irritability subscale score as primary outcome , change in other ABC-C subscale scores and partial and complete responses were compared between two groups . Twenty patients completed the trial in each group . Level of reduction and effect of time×treatment interaction in the treatment group were significant for irritability ( P=0.03 ) , lethargy/social withdrawal ( P=0.04 ) and hyperactivity/non-compliance ( P=0.03 ) but not for stereotypic behavior and inappropriate speech subscales compared with the placebo group . Vomiting and headache were the most frequent reported side-effects . Results of this preliminary study indicate positive effects of pioglitazone compared with placebo in improving the behavioral symptoms of AD ."
],
"offsets": [
[
0,
1351
]
]
}
] | [
{
"id": "72191",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
21,
39
]
],
"normalized": []
},
{
"id": "72192",
"type": "Intervention_Pharmacological",
"text": [
"pioglitazone"
],
"offsets": [
[
49,
61
]
],
"normalized": []
},
{
"id": "72193",
"type": "Intervention_Pharmacological",
"text": [
"pioglitazone added to risperidone"
],
"offsets": [
[
195,
228
]
],
"normalized": []
},
{
"id": "72194",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
21,
39
]
],
"normalized": []
},
{
"id": "72195",
"type": "Outcome_Other",
"text": [
"safety and efficacy"
],
"offsets": [
[
172,
191
]
],
"normalized": []
},
{
"id": "72196",
"type": "Outcome_Other",
"text": [
"Mean change of ABC-C irritability subscale score"
],
"offsets": [
[
596,
644
]
],
"normalized": []
},
{
"id": "72197",
"type": "Outcome_Other",
"text": [
"for irritability ( P=0.03 ) , lethargy/social withdrawal"
],
"offsets": [
[
926,
982
]
],
"normalized": []
},
{
"id": "72198",
"type": "Outcome_Other",
"text": [
"and hyperactivity/non-compliance"
],
"offsets": [
[
994,
1026
]
],
"normalized": []
},
{
"id": "72199",
"type": "Outcome_Adverse-effects",
"text": [
"Vomiting and headache"
],
"offsets": [
[
1140,
1161
]
],
"normalized": []
},
{
"id": "72200",
"type": "Outcome_Mental",
"text": [
"the behavioral symptoms of"
],
"offsets": [
[
1320,
1346
]
],
"normalized": []
},
{
"id": "72201",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
135,
143
]
],
"normalized": []
},
{
"id": "72202",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
149,
155
]
],
"normalized": []
},
{
"id": "72203",
"type": "Participant_Condition",
"text": [
"autistic disorder ( AD )"
],
"offsets": [
[
265,
289
]
],
"normalized": []
},
{
"id": "72204",
"type": "Participant_Sample-size",
"text": [
"44"
],
"offsets": [
[
414,
416
]
],
"normalized": []
},
{
"id": "72205",
"type": "Participant_Sex",
"text": [
"both genders"
],
"offsets": [
[
432,
444
]
],
"normalized": []
},
{
"id": "72206",
"type": "Participant_Age",
"text": [
"4-12 years"
],
"offsets": [
[
450,
460
]
],
"normalized": []
},
{
"id": "72207",
"type": "Participant_Condition",
"text": [
"AD"
],
"offsets": [
[
285,
287
]
],
"normalized": []
},
{
"id": "72208",
"type": "Participant_Sample-size",
"text": [
"Twenty patients"
],
"offsets": [
[
774,
789
]
],
"normalized": []
}
] | [] | [] | [] |
72209 | 26209587 | [
{
"id": "72210",
"type": "document",
"text": [
"Fixed-dose combination of AR-13324 and latanoprost : a double-masked , 28-day , randomised , controlled study in patients with open-angle glaucoma or ocular hypertension . BACKGROUND/AIMS To evaluate the ocular hypotensive efficacy of fixed-dose combinations of the Rho kinase inhibitor and norepinephrine transport inhibitor AR-13324 ( 0.01 % and 0.02 % ) and latanoprost ( PG324 Ophthalmic Solution ) relative to the active components AR-13324 0.02 % and latanoprost 0.005 % , used bilaterally at night . METHODS This was a double-masked , randomised , parallel comparison study in patients with open-angle glaucoma or ocular hypertension . After washout , patients were randomised to one of four treatment arms and treated for 28 days . The primary efficacy variable was mean diurnal intraocular pressure ( IOP ) at day 29 . RESULTS We randomised 298 patients , of whom 292 ( 98 % ) completed the study . Mean unmedicated diurnal IOPs ( study eye ) was 25.1 , 25.1 , 26.0 and 25.4 in the PG324 0.01 % , PG324 0.02 % , latanoprost and AR-13324 0.02 % groups , respectively . On day 29 , mean diurnal IOP decreased to 17.3 , 16.5 , 18.4 and 19.1 mm Hg , respectively . For the primary efficacy variable of mean diurnal IOP at day 29 , PG324 0.02 % met the criterion for statistical superiority relative to both latanoprost and AR-13324 0.02 % ( p < 0.0001 ) , providing additional IOP lowering of 1.9 and 2.6 mm Hg , respectively . PG324 0.01 % also met the criterion for superiority . The most frequently reported adverse event was conjunctival hyperaemia with an incidence of 41 % ( 30/73 ) , 40 % ( 29/73 ) , 14 % ( 10/73 ) and 40 % ( 31/78 ) in the PG324 0.01 % , PG324 0.02 % , latanoprost and AR-13324 0.02 % groups , respectively . CONCLUSIONS In this short-term study , the fixed-dose combination of AR-13324 0.02 % and latanoprost 0.005 % in PG324 Ophthalmic Solution provides clinically and statistically superior ocular hypotensive efficacy relative to its individual active components at the same concentrations . The only safety finding of note was transient asymptomatic conjunctival hyperaemia which was typically of mild severity . TRIAL REGISTRATION NUMBER NCT02207491 ."
],
"offsets": [
[
0,
2188
]
]
}
] | [
{
"id": "72211",
"type": "Intervention_Pharmacological",
"text": [
"AR-13324 and latanoprost"
],
"offsets": [
[
26,
50
]
],
"normalized": []
},
{
"id": "72212",
"type": "Intervention_Pharmacological",
"text": [
"AR-13324"
],
"offsets": [
[
26,
34
]
],
"normalized": []
},
{
"id": "72213",
"type": "Intervention_Pharmacological",
"text": [
"latanoprost"
],
"offsets": [
[
39,
50
]
],
"normalized": []
},
{
"id": "72214",
"type": "Intervention_Pharmacological",
"text": [
"AR-13324"
],
"offsets": [
[
26,
34
]
],
"normalized": []
},
{
"id": "72215",
"type": "Outcome_Other",
"text": [
"efficacy"
],
"offsets": [
[
223,
231
]
],
"normalized": []
},
{
"id": "72216",
"type": "Outcome_Physical",
"text": [
"Mean unmedicated diurnal IOPs"
],
"offsets": [
[
908,
937
]
],
"normalized": []
},
{
"id": "72217",
"type": "Outcome_Physical",
"text": [
"mean diurnal IOP"
],
"offsets": [
[
1089,
1105
]
],
"normalized": []
},
{
"id": "72218",
"type": "Outcome_Physical",
"text": [
"mean diurnal"
],
"offsets": [
[
774,
786
]
],
"normalized": []
},
{
"id": "72219",
"type": "Outcome_Adverse-effects",
"text": [
"conjunctival hyperaemia"
],
"offsets": [
[
1534,
1557
]
],
"normalized": []
},
{
"id": "72220",
"type": "Participant_Condition",
"text": [
"patients with open-angle glaucoma or ocular hypertension ."
],
"offsets": [
[
113,
171
]
],
"normalized": []
},
{
"id": "72221",
"type": "Participant_Condition",
"text": [
"patients with open-angle glaucoma or ocular hypertension ."
],
"offsets": [
[
113,
171
]
],
"normalized": []
},
{
"id": "72222",
"type": "Participant_Sample-size",
"text": [
"298 patients"
],
"offsets": [
[
850,
862
]
],
"normalized": []
},
{
"id": "72223",
"type": "Participant_Sample-size",
"text": [
"292"
],
"offsets": [
[
873,
876
]
],
"normalized": []
}
] | [] | [] | [] |
72224 | 26214440 | [
{
"id": "72225",
"type": "document",
"text": [
"Radiofrequency thermocoagulation combined with pulsed radiofrequency helps relieve postoperative complications of trigeminal neuralgia . Trigeminal neuralgia is a sudden , severe condition characterized by stabbing and recurrent pain . Radiofrequency thermocoagulation ( RFT ) and pulsed radiofrequency ( PRF ) are common surgical interventions used to treat trigeminal neuralgia . This study aimed to investigate the therapeutic effects and associated complications of a combination of RFT and PRF in the treatment of trigeminal neuralgia . Computed tomography-guided percutaneous RFT of the Gasserian ganglion was performed on 80 patients with trigeminal neuralgia . Patients were randomly assigned to either group A ( RFT at 70°C ) or group B ( RFT at 75°C ) . Patients in each group were divided into 2 subgroups , receiving percutaneous RFT ( 240 s ) with or without PRF ( 42°C , 2 Hz , 240 s ) . Six months later , pain relief and complication status were evaluated . There was no significant difference in visual analogue scores among groups with RFT at 70° or 75°C , with or without PRF . Data showed that facial numbness and postoperative masticatory muscle weakness recovered more rapidly in patients receiving combined RFT and PRF treatment . Decreased corneal reflex was relieved to a significantly greater extent in groups receiving PRF than those without . Thus , compared to the use of RFT at 75°C alone , the combination of PRF and RFT helped eliminate postoperative complications , such as facial numbness , masticatory muscle weakness , and decreased corneal reflex , indicating that it could be useful for surgically treating trigeminal neuralgia ."
],
"offsets": [
[
0,
1667
]
]
}
] | [
{
"id": "72226",
"type": "Intervention_Physical",
"text": [
"Radiofrequency thermocoagulation combined with pulsed radiofrequency"
],
"offsets": [
[
0,
68
]
],
"normalized": []
},
{
"id": "72227",
"type": "Intervention_Physical",
"text": [
"Radiofrequency thermocoagulation ( RFT ) and pulsed radiofrequency ( PRF )"
],
"offsets": [
[
236,
310
]
],
"normalized": []
},
{
"id": "72228",
"type": "Intervention_Physical",
"text": [
"Computed tomography-guided percutaneous RFT"
],
"offsets": [
[
542,
585
]
],
"normalized": []
},
{
"id": "72229",
"type": "Outcome_Pain",
"text": [
"pain relief"
],
"offsets": [
[
921,
932
]
],
"normalized": []
},
{
"id": "72230",
"type": "Outcome_Physical",
"text": [
"visual analogue scores"
],
"offsets": [
[
1013,
1035
]
],
"normalized": []
},
{
"id": "72231",
"type": "Outcome_Physical",
"text": [
"facial numbness and postoperative masticatory muscle"
],
"offsets": [
[
1114,
1166
]
],
"normalized": []
},
{
"id": "72232",
"type": "Outcome_Physical",
"text": [
"Decreased corneal reflex"
],
"offsets": [
[
1254,
1278
]
],
"normalized": []
},
{
"id": "72233",
"type": "Participant_Sample-size",
"text": [
"80"
],
"offsets": [
[
629,
631
]
],
"normalized": []
},
{
"id": "72234",
"type": "Participant_Condition",
"text": [
"trigeminal neuralgia"
],
"offsets": [
[
114,
134
]
],
"normalized": []
}
] | [] | [] | [] |
72235 | 26217065 | [
{
"id": "72236",
"type": "document",
"text": [
"REVIVE Trial : Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure . UNLABELLED Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy . Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure ( IHF ) or nonischemic heart failure ( NIHF ) . This was a prospective randomized , multicenter , open-label study of the safety and feasibility of bone marrow aspirate concentrate ( BMAC ) infused retrograde into the coronary sinus . Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control ( standard heart failure care ) in a 4:1 ratio . Accordingly , 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group . Similarly , 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group . All 60 patients were successfully enrolled in the study . The treatment groups received BMAC infusion without complications . The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline , from 25.1 % at screening to 31.1 % at 12 months ( p=.007 ) in the NIHF group and from 26.3 % to 31.1 % in the IHF group ( p=.035 ) . The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm ( p=.020 ) . Retrograde BMAC delivery is safe . All patients receiving BMAC experienced improvements in left ventricular ejection fraction , but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide . These results provide the basis for a larger clinical trial in HF patients . SIGNIFICANCE This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure . This was a multinational , multicenter study , and it is novel , translatable , and scalable . On the basis of this trial and the safety of retrograde coronary sinus infusion , there are three other trials under way using this route of delivery ."
],
"offsets": [
[
0,
2216
]
]
}
] | [
{
"id": "72237",
"type": "Intervention_Physical",
"text": [
"Cell therapy"
],
"offsets": [
[
105,
117
]
],
"normalized": []
},
{
"id": "72238",
"type": "Intervention_Physical",
"text": [
"bone marrow aspirate concentrate"
],
"offsets": [
[
494,
526
]
],
"normalized": []
},
{
"id": "72239",
"type": "Intervention_Pharmacological",
"text": [
"retrograde"
],
"offsets": [
[
262,
272
]
],
"normalized": []
},
{
"id": "72240",
"type": "Intervention_Physical",
"text": [
"BMAC infusion"
],
"offsets": [
[
661,
674
]
],
"normalized": []
},
{
"id": "72241",
"type": "Intervention_Control",
"text": [
"control"
],
"offsets": [
[
678,
685
]
],
"normalized": []
},
{
"id": "72242",
"type": "Intervention_Physical",
"text": [
"BMAC infusion"
],
"offsets": [
[
661,
674
]
],
"normalized": []
},
{
"id": "72243",
"type": "Intervention_Physical",
"text": [
"BMAC"
],
"offsets": [
[
529,
533
]
],
"normalized": []
},
{
"id": "72244",
"type": "Outcome_Physical",
"text": [
"left ventricular ejection fraction"
],
"offsets": [
[
1083,
1117
]
],
"normalized": []
},
{
"id": "72245",
"type": "Outcome_Other",
"text": [
"significant improvement"
],
"offsets": [
[
1162,
1185
]
],
"normalized": []
},
{
"id": "72246",
"type": "Outcome_Physical",
"text": [
"end-systolic diameter decreased significantly"
],
"offsets": [
[
1348,
1393
]
],
"normalized": []
},
{
"id": "72247",
"type": "Outcome_Other",
"text": [
"delivery is safe ."
],
"offsets": [
[
1474,
1492
]
],
"normalized": []
},
{
"id": "72248",
"type": "Outcome_Physical",
"text": [
"left ventricular ejection fraction"
],
"offsets": [
[
1083,
1117
]
],
"normalized": []
},
{
"id": "72249",
"type": "Outcome_Physical",
"text": [
"left ventricular end-systolic diameter and B-type natriuretic peptide ."
],
"offsets": [
[
1634,
1705
]
],
"normalized": []
}
] | [] | [] | [] |
72250 | 26223240 | [
{
"id": "72251",
"type": "document",
"text": [
"Women With Gestational Diabetes Mellitus Randomized to a Higher-Complex Carbohydrate/Low-Fat Diet Manifest Lower Adipose Tissue Insulin Resistance , Inflammation , Glucose , and Free Fatty Acids : A Pilot Study . OBJECTIVE Diet therapy in gestational diabetes mellitus ( GDM ) has focused on carbohydrate restriction but is poorly substantiated . In this pilot randomized clinical trial , we challenged the conventional low-carbohydrate/higher-fat ( LC/CONV ) diet , hypothesizing that a higher-complex carbohydrate/lower-fat ( CHOICE ) diet would improve maternal insulin resistance ( IR ) , adipose tissue ( AT ) lipolysis , and infant adiposity . RESEARCH DESIGN AND METHODS At 31 weeks , 12 diet-controlled overweight/obese women with GDM were randomized to an isocaloric LC/CONV ( 40 % carbohydrate/45 % fat/15 % protein ; n = 6 ) or CHOICE ( 60 % /25 % /15 % ; n = 6 ) diet . All meals were provided . AT was biopsied at 37 weeks . RESULTS After ∼7 weeks , fasting glucose ( P = 0.03 ) and free fatty acids ( P = 0.06 ) decreased on CHOICE , whereas fasting glucose increased on LC/CONV ( P = 0.03 ) . Insulin suppression of AT lipolysis was improved on CHOICE versus LC/CONV ( 56 vs. 31 % , P = 0.005 ) , consistent with improved IR . AT expression of multiple proinflammatory genes was lower on CHOICE ( P < 0.01 ) . Infant adiposity trended lower with CHOICE ( 10.1 ± 1.4 vs. 12.6 ± 2 % , respectively ) . CONCLUSIONS A CHOICE diet may improve maternal IR and infant adiposity , challenging recommendations for a LC/CONV diet ."
],
"offsets": [
[
0,
1536
]
]
}
] | [
{
"id": "72252",
"type": "Intervention_Physical",
"text": [
"conventional low-carbohydrate/higher-fat ( LC/CONV ) diet"
],
"offsets": [
[
407,
464
]
],
"normalized": []
},
{
"id": "72253",
"type": "Intervention_Physical",
"text": [
"higher-complex carbohydrate/lower-fat ( CHOICE ) diet"
],
"offsets": [
[
488,
541
]
],
"normalized": []
},
{
"id": "72254",
"type": "Intervention_Physical",
"text": [
"CHOICE"
],
"offsets": [
[
528,
534
]
],
"normalized": []
},
{
"id": "72255",
"type": "Intervention_Physical",
"text": [
"diet"
],
"offsets": [
[
460,
464
]
],
"normalized": []
},
{
"id": "72256",
"type": "Intervention_Physical",
"text": [
"meals"
],
"offsets": [
[
886,
891
]
],
"normalized": []
},
{
"id": "72257",
"type": "Outcome_Physical",
"text": [
"maternal insulin resistance ( IR ) , adipose tissue ( AT ) lipolysis , and infant adiposity ."
],
"offsets": [
[
556,
649
]
],
"normalized": []
}
] | [] | [] | [] |
72258 | 26224825 | [
{
"id": "72259",
"type": "document",
"text": [
"Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius : analysis from the DRAFFT trial . We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial ( DRAFFT ) to compare the relative cost effectiveness of percutaneous Kirschner wire ( K-wire ) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius . The cost effectiveness analysis ( cost per quality-adjusted life year ; QALY ) was derived from a multi-centre , two-arm , parallel group , assessor-blind , randomised controlled trial which took place in 18 trauma centres in the United Kingdom . Data from 460 patients were available for analysis , which includes both a National Health Service cost perspective including costs of surgery , implants and healthcare resource use over a 12-month period after surgery , and a societal perspective , which includes the cost of time off work and the need for additional private care . There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires . At a mean additional cost of £714 ( 95 % confidence interval 588 to 865 ) per patient , locking-plate fixation presented an incremental cost effectiveness ratio ( ICER ) of £89,322 per QALY within the first 12 months of treatment . Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires . These were greater than £30,000 . Compared with locking-plate fixation , K-wire fixation is a 'cost saving ' intervention , with similar health benefits ."
],
"offsets": [
[
0,
1715
]
]
}
] | [
{
"id": "72260",
"type": "Intervention_Physical",
"text": [
"treatment with percutaneous Kirschner wires versus volar locking plate"
],
"offsets": [
[
22,
92
]
],
"normalized": []
},
{
"id": "72261",
"type": "Intervention_Surgical",
"text": [
"percutaneous Kirschner wire ( K-wire ) fixation"
],
"offsets": [
[
358,
405
]
],
"normalized": []
},
{
"id": "72262",
"type": "Intervention_Physical",
"text": [
"and"
],
"offsets": [
[
406,
409
]
],
"normalized": []
},
{
"id": "72263",
"type": "Intervention_Surgical",
"text": [
"volar locking-plate fixation"
],
"offsets": [
[
410,
438
]
],
"normalized": []
},
{
"id": "72264",
"type": "Intervention_Surgical",
"text": [
"locking-plate fixation"
],
"offsets": [
[
416,
438
]
],
"normalized": []
},
{
"id": "72265",
"type": "Intervention_Surgical",
"text": [
"K-wires ."
],
"offsets": [
[
1213,
1222
]
],
"normalized": []
},
{
"id": "72266",
"type": "Outcome_Other",
"text": [
"Cost effectiveness of treatment with percutaneous Kirschner wires"
],
"offsets": [
[
0,
65
]
],
"normalized": []
},
{
"id": "72267",
"type": "Outcome_Other",
"text": [
"( cost per quality-adjusted life year ; QALY )"
],
"offsets": [
[
541,
587
]
],
"normalized": []
},
{
"id": "72268",
"type": "Outcome_Other",
"text": [
"costs of surgery , implants"
],
"offsets": [
[
882,
909
]
],
"normalized": []
},
{
"id": "72269",
"type": "Outcome_Other",
"text": [
"healthcare resource use"
],
"offsets": [
[
914,
937
]
],
"normalized": []
},
{
"id": "72270",
"type": "Outcome_Other",
"text": [
"cost of time off work"
],
"offsets": [
[
1025,
1046
]
],
"normalized": []
},
{
"id": "72271",
"type": "Outcome_Other",
"text": [
"additional private care ."
],
"offsets": [
[
1064,
1089
]
],
"normalized": []
},
{
"id": "72272",
"type": "Outcome_Other",
"text": [
"QALYs"
],
"offsets": [
[
1127,
1132
]
],
"normalized": []
},
{
"id": "72273",
"type": "Outcome_Other",
"text": [
"an incremental cost effectiveness ratio ( ICER )"
],
"offsets": [
[
1344,
1392
]
],
"normalized": []
},
{
"id": "72274",
"type": "Outcome_Other",
"text": [
"the ICER"
],
"offsets": [
[
1502,
1510
]
],
"normalized": []
},
{
"id": "72275",
"type": "Participant_Age",
"text": [
"adult"
],
"offsets": [
[
97,
102
]
],
"normalized": []
},
{
"id": "72276",
"type": "Participant_Condition",
"text": [
"dorsally-displaced fractures of the distal radius"
],
"offsets": [
[
457,
506
]
],
"normalized": []
},
{
"id": "72277",
"type": "Participant_Condition",
"text": [
"trauma"
],
"offsets": [
[
717,
723
]
],
"normalized": []
},
{
"id": "72278",
"type": "Participant_Sample-size",
"text": [
"460"
],
"offsets": [
[
766,
769
]
],
"normalized": []
}
] | [] | [] | [] |
72279 | 26225500 | [
{
"id": "72280",
"type": "document",
"text": [
"Quadratus lumborum block for postoperative pain after caesarean section : A randomised controlled trial . BACKGROUND Effective postoperative analgesia after caesarean section is important because it enables early ambulation and facilitates breast-feeding . Several case reports have shown that local anaesthetic injection around the quadratus lumborum muscle is effective in providing pain relief after various abdominal operations and in patients with chronic pain . The quadratus lumborum block ( QLB ) is performed in close proximity to the surface and uses a fascial compartment path to extend the distribution of local anaesthesia into the posterior abdominal wall and paravertebral space . This central effect can be of vital importance when managing the visceral pain after caesarean section . OBJECTIVE We hypothesised that the QLB after caesarean section can provide adequate pain relief as part of a multimodal approach . DESIGN Double-blind , randomised and controlled clinical trial . SETTING A single centre between June 2014 and December 2014 . PATIENTS Fifty patients who were American Society of Anesthesiologists physical status 1 or 2 , with normal singleton pregnancies with a gestation of at least 37 weeks , and scheduled for elective caesarean section under spinal anaesthesia , were enrolled into the study . They were randomly assigned to receive a QLB ( n = 25 ) with 0.125 % bupivacaine 0.2 ml kg⁻¹ ( Group 1 ) or a QLB ( n = 25 ) with 0.9 % Normal saline 0.2 ml kg⁻¹ ( Group 2 ) . MAIN OUTCOME MEASURES The primary outcome measure for the study was the morphine demands and doses delivered by a patient-controlled analgesia system at predetermined intervals ( 1 , 2 , 4 , 6 , 12 , 24 and 48 h ) after surgery . The secondary endpoints were visual analogue scale ( VAS ) for pain at rest and on movement ( dynamic ) , heart rate , blood pressure , pruritus , itching , nausea , vomiting and sedation . RESULTS The patients who received local anaesthetic used significantly less morphine than the control group ( P < 0.001 ) at 6 and 12 h , but not at 24 and 48 hours after caesarean section . The local anaesthetic group had significantly less morphine demand than the control group ( P < 0.001 ) 6 , 12 , 24 and 48 h after caesarean section . The VAS was significantly lower in the local anaesthetic group than the control group , including VAS for pain at rest at all times except 24 h after caesarean section , and VAS for pain on movement ( dynamic ) at all times . CONCLUSION The QLB after caesarean section was effective and provided satisfactory analgesia in combination with a typical postoperative analgesic regimen . TRIAL REGISTRATION ClinicalTrials.gov identifier : NCT02328378 ."
],
"offsets": [
[
0,
2717
]
]
}
] | [
{
"id": "72281",
"type": "Intervention_Physical",
"text": [
"lumborum block"
],
"offsets": [
[
10,
24
]
],
"normalized": []
},
{
"id": "72282",
"type": "Intervention_Surgical",
"text": [
"caesarean section"
],
"offsets": [
[
54,
71
]
],
"normalized": []
},
{
"id": "72283",
"type": "Intervention_Surgical",
"text": [
"caesarean"
],
"offsets": [
[
54,
63
]
],
"normalized": []
},
{
"id": "72284",
"type": "Intervention_Physical",
"text": [
"local anaesthetic injection"
],
"offsets": [
[
294,
321
]
],
"normalized": []
},
{
"id": "72285",
"type": "Intervention_Physical",
"text": [
"quadratus lumborum block"
],
"offsets": [
[
472,
496
]
],
"normalized": []
},
{
"id": "72286",
"type": "Intervention_Physical",
"text": [
"QLB"
],
"offsets": [
[
499,
502
]
],
"normalized": []
},
{
"id": "72287",
"type": "Intervention_Pharmacological",
"text": [
"bupivacaine"
],
"offsets": [
[
1401,
1412
]
],
"normalized": []
},
{
"id": "72288",
"type": "Outcome_Pain",
"text": [
"postoperative pain"
],
"offsets": [
[
29,
47
]
],
"normalized": []
},
{
"id": "72289",
"type": "Outcome_Pain",
"text": [
"visceral pain"
],
"offsets": [
[
761,
774
]
],
"normalized": []
},
{
"id": "72290",
"type": "Outcome_Other",
"text": [
"morphine demands and doses"
],
"offsets": [
[
1580,
1606
]
],
"normalized": []
},
{
"id": "72291",
"type": "Outcome_Pain",
"text": [
"visual analogue scale ( VAS ) for pain at rest and on movement ( dynamic )"
],
"offsets": [
[
1767,
1841
]
],
"normalized": []
},
{
"id": "72292",
"type": "Outcome_Pain",
"text": [
"heart rate"
],
"offsets": [
[
1844,
1854
]
],
"normalized": []
},
{
"id": "72293",
"type": "Outcome_Pain",
"text": [
"blood pressure"
],
"offsets": [
[
1857,
1871
]
],
"normalized": []
},
{
"id": "72294",
"type": "Outcome_Pain",
"text": [
"pruritus"
],
"offsets": [
[
1874,
1882
]
],
"normalized": []
},
{
"id": "72295",
"type": "Outcome_Pain",
"text": [
"itching"
],
"offsets": [
[
1885,
1892
]
],
"normalized": []
},
{
"id": "72296",
"type": "Outcome_Other",
"text": [
"used significantly"
],
"offsets": [
[
1980,
1998
]
],
"normalized": []
},
{
"id": "72297",
"type": "Outcome_Other",
"text": [
"anaesthetic group had"
],
"offsets": [
[
2129,
2150
]
],
"normalized": []
},
{
"id": "72298",
"type": "Participant_Condition",
"text": [
"postoperative pain after caesarean section :"
],
"offsets": [
[
29,
73
]
],
"normalized": []
},
{
"id": "72299",
"type": "Participant_Condition",
"text": [
"patients with chronic pain ."
],
"offsets": [
[
439,
467
]
],
"normalized": []
},
{
"id": "72300",
"type": "Participant_Sample-size",
"text": [
"Fifty"
],
"offsets": [
[
1068,
1073
]
],
"normalized": []
},
{
"id": "72301",
"type": "Participant_Condition",
"text": [
"Anesthesiologists"
],
"offsets": [
[
1112,
1129
]
],
"normalized": []
},
{
"id": "72302",
"type": "Participant_Condition",
"text": [
"elective caesarean section under spinal anaesthesia"
],
"offsets": [
[
1247,
1298
]
],
"normalized": []
}
] | [] | [] | [] |
72303 | 26225700 | [
{
"id": "72304",
"type": "document",
"text": [
"Total and Partial Prevalence of Cancer Across Kerman Province , Iran , in 2014 , Using an Adapted Generalized Network Scale-Up Method . Due to the lack of nationwide population-based cancer registration , the total cancer prevalence in Iran is unknown . Our previous work in which we used a basic network scale-up ( NSU ) method , failed to provide plausible estimates of total cancer prevalence in Kerman . The aim of the present study was to estimate total and partial prevalence of cancer in southeastern Iran using an adapted version of the generalized network scale-up method . A survey was conducted in 2014 using multi-stage cluster sampling . A total of 1995 face-to-face gender-matched interviews were performed based on an adapted version of the NSU questionnaire . Interviewees were asked about their family cancer history . Total and partial prevalence were estimated using a generalized NSU estimator . The Monte Carlo method was adopted for the estimation of upper/lower bounds of the uncertainty range of point estimates . One-yr , 2-3 yr , and 4-5 yr prevalence ( per 100,000 people ) was respectively estimated at 78 ( 95 % CI , 66 , 90 ) , 128 ( 95 % CI , 118 , 147 ) , and 59 ( 95 % CI , 49 , 70 ) for women , and 48 ( 95 % CI , 38 , 58 ) , 78 ( 95 % CI , 66 , 91 ) , and 42 ( 95 % CI , 32 , 52 ) for men . The 5-yr prevalence of all cancers was estimated at 0.18 percent for men , and 0.27 percent for women . This study showed that the generalized familial network scale-up method is capable of estimating cancer prevalence , with acceptable precision ."
],
"offsets": [
[
0,
1574
]
]
}
] | [
{
"id": "72305",
"type": "Intervention_Physical",
"text": [
"NSU questionnaire"
],
"offsets": [
[
756,
773
]
],
"normalized": []
},
{
"id": "72306",
"type": "Outcome_Physical",
"text": [
"Total and Partial Prevalence of Cancer"
],
"offsets": [
[
0,
38
]
],
"normalized": []
},
{
"id": "72307",
"type": "Outcome_Physical",
"text": [
"cancer prevalence"
],
"offsets": [
[
215,
232
]
],
"normalized": []
},
{
"id": "72308",
"type": "Outcome_Physical",
"text": [
"prevalence of cancer"
],
"offsets": [
[
471,
491
]
],
"normalized": []
},
{
"id": "72309",
"type": "Outcome_Physical",
"text": [
"Total and partial prevalence"
],
"offsets": [
[
836,
864
]
],
"normalized": []
},
{
"id": "72310",
"type": "Outcome_Physical",
"text": [
"One-yr , 2-3 yr , and 4-5 yr prevalence"
],
"offsets": [
[
1038,
1077
]
],
"normalized": []
},
{
"id": "72311",
"type": "Outcome_Physical",
"text": [
"5-yr prevalence of all cancers"
],
"offsets": [
[
1330,
1360
]
],
"normalized": []
},
{
"id": "72312",
"type": "Outcome_Physical",
"text": [
"cancer prevalence"
],
"offsets": [
[
215,
232
]
],
"normalized": []
},
{
"id": "72313",
"type": "Participant_Condition",
"text": [
"Cancer"
],
"offsets": [
[
32,
38
]
],
"normalized": []
}
] | [] | [] | [] |
72314 | 26244758 | [
{
"id": "72315",
"type": "document",
"text": [
"A Comparison of Outcomes Following Laparoscopic and Open Hysterectomy With or Without Lymphadenectomy for Presumed Early-Stage Endometrial Cancer : Results From the Medical Research Council ASTEC Trial . OBJECTIVES Laparoscopic hysterectomy ( LH ) is increasingly used for the management of endometrial malignancy . Its benefits may be particularly pronounced as these women are more likely to be older or obese . The aim of this study was to determine whether outcomes for LH are comparable to the open hysterectomy ( OH ) . DESIGN This was a prospective cohort study nested within the multicenter ASTEC ( A Study in the Treatment of Endometrial Cancer ) randomized controlled trial ( 1998-2005 ) . POPULATION Women with presumed early endometrial cancer were included . METHODS Laparoscopic hysterectomy was compared with OH with or without systematic lymphadenectomy . MAIN OUTCOME MEASURES Overall survival , time to first recurrence , complication rates , and surgical outcomes were the main outcome measures . RESULTS Of 1408 women , 1309 ( 93 % ) received OH , and 99 ( 7 % ) had LH . LH was associated with longer operating time ( median , LH 105 minutes [ interquartile range ( IQR ) , 60-150 ] vs OH 80 minutes [ IQR , 60-95 ] ; P < 0.001 ) but 50 % shorter hospital stay ( median , LH 4 days [ IQR , 3-5 ] vs OH 6 days [ IQR , 5-7 ] ) . The number of harvested lymph nodes was similar ( median , LH 13 [ IQR , 10-16 ] vs OH 12 [ IQR , 11-13 ] ; P = 0.67 ) . LH had fewer intraoperative and postoperative adverse events ( 9 % difference , LH 21 % vs OH 30 % ; borderline significance ; P = 0.07 ) . The rate of conversion to laparotomy for the LH group was high ( 27 % ) . The median follow-up was 37 months . After adjusting for significant prognostic factors , the hazard ratio for overall survival in those who underwent LH compared with those who underwent OH was 0.67 ( 95 % confidence interval , 0.31-1.43 ) ( P = 0.30 ) . CONCLUSIONS Laparoscopic hysterectomy for early endometrial cancer is safe . Although it requires longer operating time it is associated with shorter hospital stay and favorable morbidity profile . Further studies are required to assess the long-term safety ."
],
"offsets": [
[
0,
2198
]
]
}
] | [
{
"id": "72316",
"type": "Intervention_Surgical",
"text": [
"Laparoscopic"
],
"offsets": [
[
35,
47
]
],
"normalized": []
},
{
"id": "72317",
"type": "Intervention_Surgical",
"text": [
"Open Hysterectomy"
],
"offsets": [
[
52,
69
]
],
"normalized": []
},
{
"id": "72318",
"type": "Intervention_Surgical",
"text": [
"Laparoscopic hysterectomy ( LH )"
],
"offsets": [
[
215,
247
]
],
"normalized": []
},
{
"id": "72319",
"type": "Intervention_Surgical",
"text": [
"Laparoscopic hysterectomy"
],
"offsets": [
[
215,
240
]
],
"normalized": []
},
{
"id": "72320",
"type": "Intervention_Physical",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72321",
"type": "Intervention_Physical",
"text": [
"systematic lymphadenectomy"
],
"offsets": [
[
843,
869
]
],
"normalized": []
},
{
"id": "72322",
"type": "Intervention_Surgical",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
},
{
"id": "72323",
"type": "Intervention_Surgical",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72324",
"type": "Intervention_Surgical",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72325",
"type": "Intervention_Surgical",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
},
{
"id": "72326",
"type": "Intervention_Surgical",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72327",
"type": "Intervention_Surgical",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
},
{
"id": "72328",
"type": "Intervention_Surgical",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
},
{
"id": "72329",
"type": "Intervention_Surgical",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
},
{
"id": "72330",
"type": "Intervention_Surgical",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72331",
"type": "Intervention_Surgical",
"text": [
"Laparoscopic hysterectomy"
],
"offsets": [
[
215,
240
]
],
"normalized": []
},
{
"id": "72332",
"type": "Outcome_Physical",
"text": [
"Overall survival"
],
"offsets": [
[
894,
910
]
],
"normalized": []
},
{
"id": "72333",
"type": "Outcome_Mental",
"text": [
"time to first recurrence"
],
"offsets": [
[
913,
937
]
],
"normalized": []
},
{
"id": "72334",
"type": "Outcome_Mental",
"text": [
"complication rates"
],
"offsets": [
[
940,
958
]
],
"normalized": []
},
{
"id": "72335",
"type": "Outcome_Mental",
"text": [
"surgical outcomes"
],
"offsets": [
[
965,
982
]
],
"normalized": []
},
{
"id": "72336",
"type": "Outcome_Other",
"text": [
"operating time"
],
"offsets": [
[
1122,
1136
]
],
"normalized": []
},
{
"id": "72337",
"type": "Outcome_Other",
"text": [
"hospital stay"
],
"offsets": [
[
1268,
1281
]
],
"normalized": []
},
{
"id": "72338",
"type": "Outcome_Physical",
"text": [
"number of harvested lymph nodes"
],
"offsets": [
[
1352,
1383
]
],
"normalized": []
},
{
"id": "72339",
"type": "Outcome_Adverse-effects",
"text": [
"intraoperative and postoperative adverse events"
],
"offsets": [
[
1482,
1529
]
],
"normalized": []
},
{
"id": "72340",
"type": "Outcome_Other",
"text": [
"rate of conversion to laparotomy"
],
"offsets": [
[
1613,
1645
]
],
"normalized": []
},
{
"id": "72341",
"type": "Outcome_Mortality",
"text": [
"hazard ratio for overall survival"
],
"offsets": [
[
1777,
1810
]
],
"normalized": []
},
{
"id": "72342",
"type": "Outcome_Other",
"text": [
"operating time"
],
"offsets": [
[
1122,
1136
]
],
"normalized": []
},
{
"id": "72343",
"type": "Outcome_Physical",
"text": [
"hospital stay"
],
"offsets": [
[
1268,
1281
]
],
"normalized": []
},
{
"id": "72344",
"type": "Outcome_Mortality",
"text": [
"morbidity profile"
],
"offsets": [
[
2117,
2134
]
],
"normalized": []
},
{
"id": "72345",
"type": "Outcome_Other",
"text": [
"long-term safety"
],
"offsets": [
[
2180,
2196
]
],
"normalized": []
},
{
"id": "72346",
"type": "Participant_Condition",
"text": [
"Presumed Early-Stage Endometrial Cancer"
],
"offsets": [
[
106,
145
]
],
"normalized": []
},
{
"id": "72347",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
369,
374
]
],
"normalized": []
},
{
"id": "72348",
"type": "Participant_Age",
"text": [
"older"
],
"offsets": [
[
397,
402
]
],
"normalized": []
},
{
"id": "72349",
"type": "Participant_Sex",
"text": [
"Women"
],
"offsets": [
[
711,
716
]
],
"normalized": []
},
{
"id": "72350",
"type": "Participant_Sample-size",
"text": [
"1408"
],
"offsets": [
[
1027,
1031
]
],
"normalized": []
},
{
"id": "72351",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
369,
374
]
],
"normalized": []
},
{
"id": "72352",
"type": "Participant_Sample-size",
"text": [
"1309"
],
"offsets": [
[
1040,
1044
]
],
"normalized": []
},
{
"id": "72353",
"type": "Participant_Condition",
"text": [
"OH"
],
"offsets": [
[
519,
521
]
],
"normalized": []
},
{
"id": "72354",
"type": "Participant_Sample-size",
"text": [
"99"
],
"offsets": [
[
687,
689
]
],
"normalized": []
},
{
"id": "72355",
"type": "Participant_Condition",
"text": [
"LH"
],
"offsets": [
[
243,
245
]
],
"normalized": []
}
] | [] | [] | [] |
72356 | 26266420 | [
{
"id": "72357",
"type": "document",
"text": [
"Homocysteine Metabolism Gene Polymorphisms ( MTHFR C677T , MTHFR A1298C , MTR A2756G and MTRR A66G ) Jointly Elevate the Risk of Folate Deficiency . Folate deficiency is strongly associated with cardiovascular disease . We aimed to explore the joint effect of the methylenetetrahydrofolate reductase ( MTHFR ) C677T and A1298C , methionine synthase ( MTR ) A2756G , and methionine synthase reductase ( MTRR ) A66G polymorphisms on folate deficiency in a Chinese hypertensive population . A total of 480 subjects aged 28-75 were enrolled in this study from September 2005-December 2005 from six hospitals in different Chinese regions . Known genotypes were detected by PCR-RFLP methods and serum folate was measured by chemiluminescence immunoassay . Our results showed that MTHFR 677TT and MTR 2756AG + GG were independently associated with a higher risk of folate deficiency ( TT vs. CC + CT , p < 0.001 and AG + GG vs. AA p = 0.030 , respectively ) . However , the MTHFR A1298C mutation may confer protection by elevating the serum folate level ( p = 0.025 ) . Furthermore , patients carrying two or more risk genotypes showed higher odds of folate deficiency than null risk genotype carriers , especially those carrying four risk genotypes . These findings were verified by generalized multifactor dimensionality reduction ( p = 0.0107 ) and a cumulative effects model ( p = 0.001 ) . The results of this study have shown that interactions among homocysteine metabolism gene polymorphisms lead to dramatic elevations in the folate deficiency risk ."
],
"offsets": [
[
0,
1551
]
]
}
] | [
{
"id": "72358",
"type": "Intervention_Pharmacological",
"text": [
"methylenetetrahydrofolate reductase ( MTHFR ) C677T and A1298C"
],
"offsets": [
[
264,
326
]
],
"normalized": []
},
{
"id": "72359",
"type": "Intervention_Pharmacological",
"text": [
"methionine synthase ( MTR ) A2756G"
],
"offsets": [
[
329,
363
]
],
"normalized": []
},
{
"id": "72360",
"type": "Intervention_Pharmacological",
"text": [
"methionine synthase reductase ( MTRR ) A66G"
],
"offsets": [
[
370,
413
]
],
"normalized": []
},
{
"id": "72361",
"type": "Intervention_Pharmacological",
"text": [
"MTHFR 677TT"
],
"offsets": [
[
774,
785
]
],
"normalized": []
},
{
"id": "72362",
"type": "Intervention_Pharmacological",
"text": [
"MTR 2756AG + GG"
],
"offsets": [
[
790,
805
]
],
"normalized": []
},
{
"id": "72363",
"type": "Intervention_Pharmacological",
"text": [
"MTHFR A1298C"
],
"offsets": [
[
59,
71
]
],
"normalized": []
},
{
"id": "72364",
"type": "Outcome_Physical",
"text": [
"folate deficiency"
],
"offsets": [
[
431,
448
]
],
"normalized": []
},
{
"id": "72365",
"type": "Outcome_Physical",
"text": [
"serum folate"
],
"offsets": [
[
689,
701
]
],
"normalized": []
},
{
"id": "72366",
"type": "Outcome_Other",
"text": [
"MTHFR 677TT and MTR 2756AG + GG"
],
"offsets": [
[
774,
805
]
],
"normalized": []
},
{
"id": "72367",
"type": "Outcome_Physical",
"text": [
"folate deficiency"
],
"offsets": [
[
431,
448
]
],
"normalized": []
},
{
"id": "72368",
"type": "Outcome_Physical",
"text": [
"serum folate level"
],
"offsets": [
[
1028,
1046
]
],
"normalized": []
},
{
"id": "72369",
"type": "Outcome_Physical",
"text": [
"folate deficiency"
],
"offsets": [
[
431,
448
]
],
"normalized": []
},
{
"id": "72370",
"type": "Participant_Condition",
"text": [
"Chinese hypertensive population"
],
"offsets": [
[
454,
485
]
],
"normalized": []
},
{
"id": "72371",
"type": "Participant_Age",
"text": [
"A"
],
"offsets": [
[
65,
66
]
],
"normalized": []
},
{
"id": "72372",
"type": "Participant_Sample-size",
"text": [
"480"
],
"offsets": [
[
499,
502
]
],
"normalized": []
},
{
"id": "72373",
"type": "Participant_Age",
"text": [
"aged 28-75 were"
],
"offsets": [
[
512,
527
]
],
"normalized": []
},
{
"id": "72374",
"type": "Participant_Age",
"text": [
"."
],
"offsets": [
[
147,
148
]
],
"normalized": []
}
] | [] | [] | [] |
72375 | 26279073 | [
{
"id": "72376",
"type": "document",
"text": [
"Chromium Supplementation and the Effects on Metabolic Status in Women with Polycystic Ovary Syndrome : A Randomized , Double-Blind , Placebo-Controlled Trial . BACKGROUND The aim of the present study was to evaluate the beneficial effects of chromium intake on markers of insulin metabolism and lipid profiles in women with polycystic ovary syndrome ( PCOS ) . METHODS In a prospective , randomized , double-blind , placebo-controlled trial , 64 women with PCOS were randomized to receive 200 µg chromium picolinate supplements ( n = 32 ) or placebo ( n = 32 ) for 8 weeks . Fasting blood samples were obtained at baseline and 8 weeks after the intervention to quantify markers of insulin metabolism and lipid concentrations . RESULTS Chromium supplementation in women with PCOS resulted in significant decreases in serum insulin levels ( -3.6 ± 7.4 vs. +3.6 ± 6.2 µIU/ml , p < 0.001 ) , homeostasis model of assessment-insulin resistance ( HOMA-IR ; -0.8 ± 1.6 vs. +0.9 ± 1.5 , p < 0.001 ) , homeostatic model assessment-beta cell function ( HOMA-B ; -15.5 ± 32.3 vs. +13.6 ± 23.1 , p < 0.001 ) , and a significant increase in quantitative insulin sensitivity check index ( QUICKI ) score ( +0.02 ± 0.03 vs. -0.008 ± 0.02 , p = 0.001 ) compared with the placebo . In addition , a trend toward a significant effect of chromium supplementation on decreasing serum triglycerides ( -12.4 ± 74.4 vs. +15.2 ± 32.4 mg/dl , p = 0.05 ) , very low-density lipoprotein-cholesterol ( -2.5 ± 14.9 vs. +3.0 ± 6.5 mg/dl , p = 0.05 ) , and cholesterol concentrations ( -8.6 ± 21.9 vs. +0.7 ± 22.4 mg/dl , p = 0.09 ) was seen . CONCLUSIONS Eight weeks of chromium supplementation among PCOS women had favorable effects on markers of insulin metabolism ."
],
"offsets": [
[
0,
1737
]
]
}
] | [
{
"id": "72377",
"type": "Intervention_Pharmacological",
"text": [
"Chromium Supplementation"
],
"offsets": [
[
0,
24
]
],
"normalized": []
},
{
"id": "72378",
"type": "Intervention_Pharmacological",
"text": [
"chromium"
],
"offsets": [
[
242,
250
]
],
"normalized": []
},
{
"id": "72379",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
416,
434
]
],
"normalized": []
},
{
"id": "72380",
"type": "Intervention_Pharmacological",
"text": [
"Chromium"
],
"offsets": [
[
0,
8
]
],
"normalized": []
},
{
"id": "72381",
"type": "Outcome_Physical",
"text": [
"Metabolic Status"
],
"offsets": [
[
44,
60
]
],
"normalized": []
},
{
"id": "72382",
"type": "Outcome_Physical",
"text": [
"insulin metabolism"
],
"offsets": [
[
272,
290
]
],
"normalized": []
},
{
"id": "72383",
"type": "Outcome_Physical",
"text": [
"lipid profiles"
],
"offsets": [
[
295,
309
]
],
"normalized": []
},
{
"id": "72384",
"type": "Participant_Sex",
"text": [
"Women"
],
"offsets": [
[
64,
69
]
],
"normalized": []
},
{
"id": "72385",
"type": "Participant_Condition",
"text": [
"Polycystic Ovary Syndrome"
],
"offsets": [
[
75,
100
]
],
"normalized": []
},
{
"id": "72386",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
313,
318
]
],
"normalized": []
},
{
"id": "72387",
"type": "Participant_Condition",
"text": [
"polycystic ovary syndrome ( PCOS )"
],
"offsets": [
[
324,
358
]
],
"normalized": []
},
{
"id": "72388",
"type": "Participant_Sample-size",
"text": [
"64"
],
"offsets": [
[
443,
445
]
],
"normalized": []
},
{
"id": "72389",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
313,
318
]
],
"normalized": []
},
{
"id": "72390",
"type": "Participant_Condition",
"text": [
"PCOS"
],
"offsets": [
[
352,
356
]
],
"normalized": []
}
] | [] | [] | [] |
72391 | 26279130 | [
{
"id": "72392",
"type": "document",
"text": [
"The VA augmentation and switching treatments for improving depression outcomes ( VAST-D ) study : Rationale and design considerations . Because two-thirds of patients with Major Depressive Disorder do not achieve remission with their first antidepressant , we designed a trial of three \" next-step \" strategies : switching to another antidepressant ( bupropion-SR ) or augmenting the current antidepressant with either another antidepressant ( bupropion-SR ) or with an atypical antipsychotic ( aripiprazole ) . The study will compare 12-week remission rates and , among those who have at least a partial response , relapse rates for up to 6 months of additional treatment . We review seven key efficacy/effectiveness design decisions in this mixed \" efficacy-effectiveness \" trial ."
],
"offsets": [
[
0,
783
]
]
}
] | [
{
"id": "72393",
"type": "Intervention_Physical",
"text": [
"VA augmentation"
],
"offsets": [
[
4,
19
]
],
"normalized": []
},
{
"id": "72394",
"type": "Intervention_Pharmacological",
"text": [
"and"
],
"offsets": [
[
20,
23
]
],
"normalized": []
},
{
"id": "72395",
"type": "Intervention_Physical",
"text": [
"switching treatments"
],
"offsets": [
[
24,
44
]
],
"normalized": []
},
{
"id": "72396",
"type": "Intervention_Physical",
"text": [
"switching to another antidepressant ("
],
"offsets": [
[
313,
350
]
],
"normalized": []
},
{
"id": "72397",
"type": "Intervention_Pharmacological",
"text": [
"bupropion-SR"
],
"offsets": [
[
351,
363
]
],
"normalized": []
},
{
"id": "72398",
"type": "Intervention_Physical",
"text": [
")"
],
"offsets": [
[
88,
89
]
],
"normalized": []
},
{
"id": "72399",
"type": "Intervention_Pharmacological",
"text": [
"augmenting the current antidepressant with either another antidepressant ( bupropion-SR ) or with an atypical antipsychotic ( aripiprazole )"
],
"offsets": [
[
369,
509
]
],
"normalized": []
},
{
"id": "72400",
"type": "Outcome_Physical",
"text": [
"12-week remission rates"
],
"offsets": [
[
535,
558
]
],
"normalized": []
},
{
"id": "72401",
"type": "Outcome_Physical",
"text": [
"relapse rates"
],
"offsets": [
[
616,
629
]
],
"normalized": []
},
{
"id": "72402",
"type": "Participant_Condition",
"text": [
"Major Depressive Disorder"
],
"offsets": [
[
172,
197
]
],
"normalized": []
}
] | [] | [] | [] |
72403 | 26315857 | [
{
"id": "72404",
"type": "document",
"text": [
"Recruitment and Reasons for Non-Participation in a Family-Coping-Orientated Palliative Home Care Trial ( FamCope ) . Cancer patients and their family caregivers need support to cope with physical , psychosocial , and existential problems early in the palliative care trajectory . Many interventions target patient symptomatology , with health care professionals acting as problem-solvers . Family coping , however , is a new research area within palliative care . The FamCope intervention was developed to test if a nurse-led family-coping-orientated palliative home care intervention would help families cope with physical and psychosocial problems at home -- together as a family and in interaction with health care professionals . However , an unexpectedly high number of families declined participation in the trial . We describe and discuss the recruitment strategy and patient reported reasons for non-participation to add to the knowledge about what impedes recruitment and to identify the factors that influence willingness to participate in research aimed at family coping early in the palliative care trajectory . Patients with advanced cancer and their closest relative were recruited from medical , surgical , and oncological departments . Reasons for non-participation were registered and characteristics of participants and non-participants were compared to evaluate differences between subgroups of non-participants based on reasons not to participate and reasons to participate in the trial . A total of 65.9 % of the families declined participation . Two main categories for declining participation emerged : first , that the \" burden of illness is too great \" and , second , that it was \" too soon \" to receive this kind of support . Men were more likely to participate than women . Patients in the \" too soon \" group had similar characteristics to participants in the trial . Timing of interventions and readiness of patients and their relatives seems to affect willingness to receive a family-coping-orientated care approach and impeded recruitment to this trial . Our findings can be used in further research and in clinical practice in order to construct interventions and target relevant populations for early family-coping-orientated palliative care ."
],
"offsets": [
[
0,
2275
]
]
}
] | [
{
"id": "72405",
"type": "Intervention_Educational",
"text": [
"Family-Coping-Orientated Palliative Home Care"
],
"offsets": [
[
51,
96
]
],
"normalized": []
},
{
"id": "72406",
"type": "Intervention_Educational",
"text": [
"FamCope intervention"
],
"offsets": [
[
468,
488
]
],
"normalized": []
},
{
"id": "72407",
"type": "Intervention_Educational",
"text": [
"nurse-led family-coping-orientated palliative home care intervention"
],
"offsets": [
[
516,
584
]
],
"normalized": []
},
{
"id": "72408",
"type": "Intervention_Educational",
"text": [
"palliative care"
],
"offsets": [
[
251,
266
]
],
"normalized": []
},
{
"id": "72409",
"type": "Outcome_Other",
"text": [
"Recruitment and Reasons for Non-Participation"
],
"offsets": [
[
0,
45
]
],
"normalized": []
},
{
"id": "72410",
"type": "Outcome_Other",
"text": [
"participation"
],
"offsets": [
[
793,
806
]
],
"normalized": []
},
{
"id": "72411",
"type": "Outcome_Other",
"text": [
"recruitment strategy"
],
"offsets": [
[
850,
870
]
],
"normalized": []
},
{
"id": "72412",
"type": "Outcome_Mental",
"text": [
"patient reported reasons"
],
"offsets": [
[
875,
899
]
],
"normalized": []
},
{
"id": "72413",
"type": "Outcome_Other",
"text": [
"non-participation"
],
"offsets": [
[
904,
921
]
],
"normalized": []
},
{
"id": "72414",
"type": "Outcome_Other",
"text": [
"non-participation"
],
"offsets": [
[
904,
921
]
],
"normalized": []
},
{
"id": "72415",
"type": "Outcome_Other",
"text": [
"participation"
],
"offsets": [
[
793,
806
]
],
"normalized": []
},
{
"id": "72416",
"type": "Outcome_Other",
"text": [
"participation"
],
"offsets": [
[
793,
806
]
],
"normalized": []
},
{
"id": "72417",
"type": "Outcome_Other",
"text": [
"participate"
],
"offsets": [
[
1035,
1046
]
],
"normalized": []
},
{
"id": "72418",
"type": "Outcome_Mental",
"text": [
"willingness to receive a family-coping-orientated care approach"
],
"offsets": [
[
1981,
2044
]
],
"normalized": []
}
] | [] | [] | [] |
72419 | 26316279 | [
{
"id": "72420",
"type": "document",
"text": [
"Use of the learning conversation improves instructor confidence in life support training : An open randomised controlled cross-over trial comparing teaching feedback mechanisms . AIMS Feedback is vital for the effective delivery of skills-based education . We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support ( BLS ) training . METHODS Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham , United Kingdom . Six-hundred and forty healthcare students undertaking a European Resuscitation Council ( ERC ) BLS course were enrolled , each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation . Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique , prior to crossing-over and teaching with the alternative technique after a pre-defined time period . Outcome measures included skill acquisition as measured by an end-of-course competency assessment , instructors ' perception of teaching with each feedback technique and candidates ' perception of the feedback they were provided with . RESULTS Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique , including all skills-based domains . No difference was seen in either assessment pass rates ( 80.9 % sandwich technique vs. 77.2 % learning conversation ; OR 1.2 , 95 % CI 0.85-1.84 ; p=0.29 ) or any domain relating to candidates ' perception of their teaching technique . CONCLUSIONS & RELEVANCE This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology . The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition ."
],
"offsets": [
[
0,
2093
]
]
}
] | [
{
"id": "72421",
"type": "Intervention_Educational",
"text": [
"learning conversation"
],
"offsets": [
[
11,
32
]
],
"normalized": []
},
{
"id": "72422",
"type": "Intervention_Educational",
"text": [
"sandwich technique"
],
"offsets": [
[
282,
300
]
],
"normalized": []
},
{
"id": "72423",
"type": "Intervention_Educational",
"text": [
"learning conversation"
],
"offsets": [
[
11,
32
]
],
"normalized": []
},
{
"id": "72424",
"type": "Intervention_Educational",
"text": [
"teaching using either the sandwich technique or the learning conversation ."
],
"offsets": [
[
724,
799
]
],
"normalized": []
},
{
"id": "72425",
"type": "Intervention_Educational",
"text": [
"learning conversation or sandwich technique"
],
"offsets": [
[
876,
919
]
],
"normalized": []
},
{
"id": "72426",
"type": "Intervention_Educational",
"text": [
"learning conversation"
],
"offsets": [
[
11,
32
]
],
"normalized": []
},
{
"id": "72427",
"type": "Outcome_Mental",
"text": [
"skill acquisition as measured by an end-of-course competency assessment"
],
"offsets": [
[
1049,
1120
]
],
"normalized": []
},
{
"id": "72428",
"type": "Outcome_Mental",
"text": [
"instructors ' perception of teaching with each feedback technique"
],
"offsets": [
[
1123,
1188
]
],
"normalized": []
},
{
"id": "72429",
"type": "Outcome_Mental",
"text": [
"candidates ' perception of the feedback they were provided with"
],
"offsets": [
[
1193,
1256
]
],
"normalized": []
},
{
"id": "72430",
"type": "Outcome_Other",
"text": [
"instructor perception of the feedback technique"
],
"offsets": [
[
1449,
1496
]
],
"normalized": []
},
{
"id": "72431",
"type": "Outcome_Other",
"text": [
"assessment pass rates"
],
"offsets": [
[
1569,
1590
]
],
"normalized": []
},
{
"id": "72432",
"type": "Participant_Sample-size",
"text": [
"Six-hundred and forty"
],
"offsets": [
[
563,
584
]
],
"normalized": []
},
{
"id": "72433",
"type": "Participant_Sample-size",
"text": [
"Fifty-eight"
],
"offsets": [
[
800,
811
]
],
"normalized": []
}
] | [] | [] | [] |
72434 | 26317618 | [
{
"id": "72435",
"type": "document",
"text": [
"High Platelet Reactivity in Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention : Randomised Controlled Trial Comparing Prasugrel and Clopidogrel . BACKGROUND Prasugrel is more effective than clopidogrel in reducing platelet aggregation in acute coronary syndromes . Data available on prasugrel reloading in clopidogrel treated patients with high residual platelet reactivity ( HRPR ) i.e . poor responders , is limited . OBJECTIVES To determine the effects of prasugrel loading on platelet function in patients on clopidogrel and high platelet reactivity undergoing percutaneous coronary intervention for acute coronary syndrome ( ACS ) . PATIENTS Patients with ACS on clopidogrel who were scheduled for PCI found to have a platelet reactivity ≥40 AUC with the Multiplate Analyzer , i.e . \" poor responders \" were randomised to prasugrel ( 60 mg loading and 10 mg maintenance dose ) or clopidogrel ( 600 mg reloading and 150 mg maintenance dose ) . The primary outcome measure was proportion of patients with platelet reactivity < 40 AUC 4 hours after loading with study medication , and also at one hour ( secondary outcome ) . 44 patients were enrolled and the study was terminated early as clopidogrel use decreased sharply due to introduction of newer P2Y12 inhibitors . RESULTS At 4 hours after study medication 100 % of patients treated with prasugrel compared to 91 % of those treated with clopidogrel had platelet reactivity < 40 AUC ( p = 0.49 ) , while at 1 hour the proportions were 95 % and 64 % respectively ( p = 0.02 ) . Mean platelet reactivity at 4 and 1 hours after study medication in prasugrel and clopidogrel groups respectively were 12 versus 22 ( p = 0.005 ) and 19 versus 34 ( p = 0.01 ) respectively . CONCLUSIONS Routine platelet function testing identifies patients with high residual platelet reactivity ( \" poor responders \" ) on clopidogrel . A strategy of prasugrel rather than clopidogrel reloading results in earlier and more sustained suppression of platelet reactivity . Future trials need to identify if this translates into clinical benefit . TRIAL REGISTRATION ClinicalTrials.gov NCT01339026 ."
],
"offsets": [
[
0,
2165
]
]
}
] | [
{
"id": "72436",
"type": "Intervention_Pharmacological",
"text": [
"prasugrel"
],
"offsets": [
[
318,
327
]
],
"normalized": []
},
{
"id": "72437",
"type": "Intervention_Pharmacological",
"text": [
"clopidogrel"
],
"offsets": [
[
225,
236
]
],
"normalized": []
},
{
"id": "72438",
"type": "Intervention_Physical",
"text": [
"percutaneous coronary intervention"
],
"offsets": [
[
600,
634
]
],
"normalized": []
},
{
"id": "72439",
"type": "Intervention_Pharmacological",
"text": [
"clopidogrel"
],
"offsets": [
[
225,
236
]
],
"normalized": []
},
{
"id": "72440",
"type": "Intervention_Physical",
"text": [
"PCI"
],
"offsets": [
[
738,
741
]
],
"normalized": []
},
{
"id": "72441",
"type": "Intervention_Pharmacological",
"text": [
"clopidogrel"
],
"offsets": [
[
225,
236
]
],
"normalized": []
},
{
"id": "72442",
"type": "Participant_Condition",
"text": [
"Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention :"
],
"offsets": [
[
28,
114
]
],
"normalized": []
},
{
"id": "72443",
"type": "Participant_Condition",
"text": [
"acute coronary syndromes ."
],
"offsets": [
[
273,
299
]
],
"normalized": []
},
{
"id": "72444",
"type": "Participant_Condition",
"text": [
"patients on clopidogrel and high platelet reactivity undergoing percutaneous coronary intervention for acute coronary syndrome ( ACS ) ."
],
"offsets": [
[
536,
672
]
],
"normalized": []
},
{
"id": "72445",
"type": "Participant_Condition",
"text": [
"Patients with ACS"
],
"offsets": [
[
682,
699
]
],
"normalized": []
},
{
"id": "72446",
"type": "Participant_Sample-size",
"text": [
"44 patients were enrolled"
],
"offsets": [
[
1163,
1188
]
],
"normalized": []
}
] | [] | [] | [] |
72447 | 26323772 | [
{
"id": "72448",
"type": "document",
"text": [
"Effects of bench step exercise intervention on work ability in terms of cardiovascular risk factors and oxidative stress : a randomized controlled study . Work ability is partly determined by physical and mental fitness . Bench step exercise can be practiced anywhere at any time . The aim of this study was to determine the effects of a bench step exercise on work ability by examining cardiovascular risk factors and oxidative stress . Thirteen volunteers working in a warehousing industry comprised the bench step exercise group ( n=7 ) and the control group ( n=6 ) . The participants in the step exercise group were encouraged to practice the step exercise at home for 16 weeks . The step exercise improved glucose metabolism and antioxidative capacity and increased work ability by reducing absences from work and improving the prognosis of work ability . The improvement in work ability was related to a reduction in oxidative stress . These results suggest that a bench step exercise may improve work ability by reducing cardiovascular risk factors and oxidative stress ."
],
"offsets": [
[
0,
1079
]
]
}
] | [
{
"id": "72449",
"type": "Intervention_Physical",
"text": [
"bench step exercise intervention"
],
"offsets": [
[
11,
43
]
],
"normalized": []
},
{
"id": "72450",
"type": "Intervention_Physical",
"text": [
"Bench step exercise"
],
"offsets": [
[
222,
241
]
],
"normalized": []
},
{
"id": "72451",
"type": "Intervention_Physical",
"text": [
"bench step exercise"
],
"offsets": [
[
11,
30
]
],
"normalized": []
},
{
"id": "72452",
"type": "Intervention_Physical",
"text": [
"bench step exercise"
],
"offsets": [
[
11,
30
]
],
"normalized": []
},
{
"id": "72453",
"type": "Intervention_Physical",
"text": [
"step exercise"
],
"offsets": [
[
17,
30
]
],
"normalized": []
},
{
"id": "72454",
"type": "Intervention_Physical",
"text": [
"step exercise"
],
"offsets": [
[
17,
30
]
],
"normalized": []
},
{
"id": "72455",
"type": "Intervention_Physical",
"text": [
"step exercise"
],
"offsets": [
[
17,
30
]
],
"normalized": []
},
{
"id": "72456",
"type": "Intervention_Physical",
"text": [
"bench step exercise"
],
"offsets": [
[
11,
30
]
],
"normalized": []
},
{
"id": "72457",
"type": "Outcome_Physical",
"text": [
"work ability"
],
"offsets": [
[
47,
59
]
],
"normalized": []
},
{
"id": "72458",
"type": "Outcome_Physical",
"text": [
"cardiovascular"
],
"offsets": [
[
72,
86
]
],
"normalized": []
},
{
"id": "72459",
"type": "Outcome_Physical",
"text": [
"Work ability"
],
"offsets": [
[
155,
167
]
],
"normalized": []
},
{
"id": "72460",
"type": "Outcome_Physical",
"text": [
"work ability"
],
"offsets": [
[
47,
59
]
],
"normalized": []
},
{
"id": "72461",
"type": "Outcome_Physical",
"text": [
"glucose metabolism and antioxidative capacity"
],
"offsets": [
[
712,
757
]
],
"normalized": []
},
{
"id": "72462",
"type": "Outcome_Physical",
"text": [
"work ability by reducing absences from work and improving the prognosis of work ability ."
],
"offsets": [
[
772,
861
]
],
"normalized": []
},
{
"id": "72463",
"type": "Outcome_Physical",
"text": [
"work ability"
],
"offsets": [
[
47,
59
]
],
"normalized": []
},
{
"id": "72464",
"type": "Outcome_Physical",
"text": [
"oxidative stress ."
],
"offsets": [
[
419,
437
]
],
"normalized": []
},
{
"id": "72465",
"type": "Outcome_Physical",
"text": [
"work ability"
],
"offsets": [
[
47,
59
]
],
"normalized": []
},
{
"id": "72466",
"type": "Participant_Sample-size",
"text": [
"n=7"
],
"offsets": [
[
534,
537
]
],
"normalized": []
},
{
"id": "72467",
"type": "Participant_Sample-size",
"text": [
"n=6"
],
"offsets": [
[
564,
567
]
],
"normalized": []
}
] | [] | [] | [] |
72468 | 26382998 | [
{
"id": "72469",
"type": "document",
"text": [
"Oxygen saturation targets in infants with bronchiolitis ( BIDS ) : a double-blind , randomised , equivalence trial . BACKGROUND The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90 % for children with bronchiolitis , which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections . No evidence exists to support this threshold . We aimed to assess whether the 90 % or higher target for management of oxygen supplementation was equivalent to a normoxic 94 % or higher target for infants admitted to hospital with viral bronchiolitis . METHODS We did a parallel-group , randomised , controlled , equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK ( the Bronchiolitis of Infancy Discharge Study [ BIDS ] ) . A central computer randomly allocated ( 1:1 ) infants , in varying length blocks of four and six and without stratification , to be clipped to standard oximeters ( patients treated with oxygen if pulse oxygen saturation [ SpO2 ] < 94 % ) or modified oximeters ( displayed a measured value of 90 % as 94 % , therefore oxygen not given until SpO2 < 90 % ) . All parents , clinical staff , and outcome assessors were masked to allocation . The primary outcome was time to resolution of cough ( prespecified equivalence limits of plus or minus 2 days ) in the intention-to-treat population . This trial is registered with ISRCTN , number ISRCTN28405428 . FINDINGS Between Oct 3 , and March 30 , 2012 , and Oct 1 , and March 29 , 2013 , we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters . Cough resolved by 15·0 days ( median ) in both groups ( 95 % CI for difference -1 to 2 ) and so oxygen thresholds were equivalent . We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group . In the standard care group , eight infants transferred to a high-dependency unit , 23 were readmitted , and one had a prolonged hospital stay . In the modified care group , 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital . Recorded adverse events did not differ significantly . INTERPRETATION Management of infants with bronchiolitis to an oxygen saturation target of 90 % or higher is as safe and clinically effective as one of 94 % or higher . Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children , particularly in developing nations where resources are scarce . FUNDING National Institute for Health Research , Health Technology Assessment programme ."
],
"offsets": [
[
0,
2816
]
]
}
] | [
{
"id": "72470",
"type": "Intervention_Pharmacological",
"text": [
"oxygen supplementation"
],
"offsets": [
[
505,
527
]
],
"normalized": []
},
{
"id": "72471",
"type": "Intervention_Physical",
"text": [
"standard oximeters"
],
"offsets": [
[
1065,
1083
]
],
"normalized": []
},
{
"id": "72472",
"type": "Intervention_Physical",
"text": [
"modified oximeters"
],
"offsets": [
[
1163,
1181
]
],
"normalized": []
},
{
"id": "72473",
"type": "Outcome_Physical",
"text": [
"oxygen saturation"
],
"offsets": [
[
212,
229
]
],
"normalized": []
},
{
"id": "72474",
"type": "Outcome_Physical",
"text": [
"time to resolution of cough"
],
"offsets": [
[
1383,
1410
]
],
"normalized": []
},
{
"id": "72475",
"type": "Outcome_Physical",
"text": [
"Cough"
],
"offsets": [
[
1749,
1754
]
],
"normalized": []
},
{
"id": "72476",
"type": "Outcome_Adverse-effects",
"text": [
"35 serious adverse events"
],
"offsets": [
[
1893,
1918
]
],
"normalized": []
},
{
"id": "72477",
"type": "Outcome_Adverse-effects",
"text": [
"25 serious adverse events"
],
"offsets": [
[
1964,
1989
]
],
"normalized": []
},
{
"id": "72478",
"type": "Outcome_Mental",
"text": [
"infants transferred to a high-dependency unit"
],
"offsets": [
[
2068,
2113
]
],
"normalized": []
},
{
"id": "72479",
"type": "Outcome_Mortality",
"text": [
"were readmitted"
],
"offsets": [
[
2119,
2134
]
],
"normalized": []
},
{
"id": "72480",
"type": "Outcome_Physical",
"text": [
"a high-dependency unit"
],
"offsets": [
[
2091,
2113
]
],
"normalized": []
},
{
"id": "72481",
"type": "Outcome_Mental",
"text": [
"were readmitted to hospital"
],
"offsets": [
[
2267,
2294
]
],
"normalized": []
},
{
"id": "72482",
"type": "Participant_Age",
"text": [
"infants"
],
"offsets": [
[
29,
36
]
],
"normalized": []
},
{
"id": "72483",
"type": "Participant_Condition",
"text": [
"bronchiolitis ( BIDS )"
],
"offsets": [
[
42,
64
]
],
"normalized": []
},
{
"id": "72484",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
242,
250
]
],
"normalized": []
},
{
"id": "72485",
"type": "Participant_Condition",
"text": [
"lower respiratory tract infections"
],
"offsets": [
[
350,
384
]
],
"normalized": []
},
{
"id": "72486",
"type": "Participant_Age",
"text": [
"infants aged 6 weeks to 12 months of age"
],
"offsets": [
[
720,
760
]
],
"normalized": []
},
{
"id": "72487",
"type": "Participant_Condition",
"text": [
"bronchiolitis"
],
"offsets": [
[
42,
55
]
],
"normalized": []
},
{
"id": "72488",
"type": "Participant_Sample-size",
"text": [
"308 infants"
],
"offsets": [
[
1675,
1686
]
],
"normalized": []
},
{
"id": "72489",
"type": "Participant_Age",
"text": [
"infants"
],
"offsets": [
[
29,
36
]
],
"normalized": []
},
{
"id": "72490",
"type": "Participant_Condition",
"text": [
"bronchiolitis"
],
"offsets": [
[
42,
55
]
],
"normalized": []
}
] | [] | [] | [] |
72491 | 26385172 | [
{
"id": "72492",
"type": "document",
"text": [
"An endovascular simulation exercise among radiology residents : comparison of simulation performance with and without practice . PURPOSE The purpose was to compare resident endovascular simulator performance with and without prior simulation . METHODS Radiology residents were guided through a practice simulation and lectured on endovascular therapy , then randomized to simulate femoral arterial intervention with or without prior iliac simulation . Simulator measurements , performance grading and resident surveys were recorded . RESULTS Prior simulation of iliac intervention significantly improved resident performance . In particular , it resulted in less catheter placement without a wire ( P=.01 ) , shorter time to proper catheter positioning ( P=.045 ) and use of oblique digital subtraction angiography ( P=.035 ) . Survey respondents valued the experience . CONCLUSION Endovascular simulator training improves simulation skills . Improvement of real-world performance and generalizability remain to be shown ."
],
"offsets": [
[
0,
1022
]
]
}
] | [
{
"id": "72493",
"type": "Intervention_Physical",
"text": [
"endovascular simulation exercise"
],
"offsets": [
[
3,
35
]
],
"normalized": []
},
{
"id": "72494",
"type": "Intervention_Other",
"text": [
"prior simulation"
],
"offsets": [
[
225,
241
]
],
"normalized": []
},
{
"id": "72495",
"type": "Intervention_Educational",
"text": [
"guided through a practice simulation and lectured on endovascular therapy"
],
"offsets": [
[
277,
350
]
],
"normalized": []
},
{
"id": "72496",
"type": "Intervention_Educational",
"text": [
"randomized to simulate femoral arterial intervention with or without prior iliac simulation"
],
"offsets": [
[
358,
449
]
],
"normalized": []
},
{
"id": "72497",
"type": "Intervention_Physical",
"text": [
"Prior simulation of iliac intervention"
],
"offsets": [
[
542,
580
]
],
"normalized": []
},
{
"id": "72498",
"type": "Intervention_Educational",
"text": [
"Endovascular simulator training"
],
"offsets": [
[
882,
913
]
],
"normalized": []
},
{
"id": "72499",
"type": "Outcome_Other",
"text": [
"comparison"
],
"offsets": [
[
64,
74
]
],
"normalized": []
},
{
"id": "72500",
"type": "Outcome_Other",
"text": [
"simulation performance"
],
"offsets": [
[
78,
100
]
],
"normalized": []
},
{
"id": "72501",
"type": "Outcome_Other",
"text": [
"compare"
],
"offsets": [
[
156,
163
]
],
"normalized": []
},
{
"id": "72502",
"type": "Outcome_Physical",
"text": [
"endovascular simulator performance"
],
"offsets": [
[
173,
207
]
],
"normalized": []
},
{
"id": "72503",
"type": "Outcome_Physical",
"text": [
"Simulator measurements"
],
"offsets": [
[
452,
474
]
],
"normalized": []
},
{
"id": "72504",
"type": "Outcome_Physical",
"text": [
"performance grading and resident surveys"
],
"offsets": [
[
477,
517
]
],
"normalized": []
},
{
"id": "72505",
"type": "Outcome_Other",
"text": [
"resident performance"
],
"offsets": [
[
604,
624
]
],
"normalized": []
},
{
"id": "72506",
"type": "Outcome_Physical",
"text": [
"less catheter placement without a wire"
],
"offsets": [
[
658,
696
]
],
"normalized": []
},
{
"id": "72507",
"type": "Outcome_Physical",
"text": [
"shorter time to proper catheter positioning"
],
"offsets": [
[
709,
752
]
],
"normalized": []
},
{
"id": "72508",
"type": "Outcome_Physical",
"text": [
"use of oblique digital subtraction angiography"
],
"offsets": [
[
768,
814
]
],
"normalized": []
},
{
"id": "72509",
"type": "Outcome_Mental",
"text": [
"simulation skills"
],
"offsets": [
[
923,
940
]
],
"normalized": []
},
{
"id": "72510",
"type": "Outcome_Physical",
"text": [
"performance"
],
"offsets": [
[
89,
100
]
],
"normalized": []
},
{
"id": "72511",
"type": "Participant_Condition",
"text": [
"radiology residents :"
],
"offsets": [
[
42,
63
]
],
"normalized": []
},
{
"id": "72512",
"type": "Participant_Condition",
"text": [
"Radiology residents"
],
"offsets": [
[
252,
271
]
],
"normalized": []
}
] | [] | [] | [] |
72513 | 26388532 | [
{
"id": "72514",
"type": "document",
"text": [
"Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol , with and without skin scrubbing , for prevention of intravascular-catheter-related infection ( CLEAN ) : an open-label , multicentre , randomised , controlled , two-by-two factorial trial . BACKGROUND Intravascular-catheter-related infections are frequent life-threatening events in health care , but incidence can be decreased by improvements in the quality of care . Optimisation of skin antisepsis is essential to prevent short-term catheter-related infections . We hypothesised that chlorhexidine-alcohol would be more effective than povidone iodine-alcohol as a skin antiseptic to prevent intravascular-catheter-related infections . METHODS In this open-label , randomised controlled trial with a two-by-two factorial design , we enrolled consecutive adults ( age ≥18 years ) admitted to one of 11 French intensive-care units and requiring at least one of central-venous , haemodialysis , or arterial catheters . Before catheter insertion , we randomly assigned ( 1:1:1:1 ) patients via a secure web-based random-number generator ( permuted blocks of eight , stratified by centre ) to have all intravascular catheters prepared with 2 % chlorhexidine-70 % isopropyl alcohol ( chlorhexidine-alcohol ) or 5 % povidone iodine-69 % ethanol ( povidone iodine-alcohol ) , with or without scrubbing of the skin with detergent before antiseptic application . Physicians and nurses were not masked to group assignment but microbiologists and outcome assessors were . The primary outcome was the incidence of catheter-related infections with chlorhexidine-alcohol versus povidone iodine-alcohol in the intention-to-treat population . This study is registered with ClinicalTrials.gov , number NCT01629550 and is closed to new participants . FINDINGS Between Oct 26 , 2012 , and Feb 12 , 2014 , 2546 patients were eligible to participate in the study . We randomly assigned 1181 patients ( 2547 catheters ) to chlorhexidine-alcohol ( 594 patients with scrubbing , 587 without ) and 1168 ( 2612 catheters ) to povidone iodine-alcohol ( 580 patients with scrubbing , 588 without ) . Chlorhexidine-alcohol was associated with lower incidence of catheter-related infections ( 0·28 vs 1·77 per 1000 catheter-days with povidone iodine-alcohol ; hazard ratio 0·15 , 95 % CI 0·05-0·41 ; p=0·0002 ) . Scrubbing was not associated with a significant difference in catheter colonisation ( p=0·3877 ) . No systemic adverse events were reported , but severe skin reactions occurred more frequently in those assigned to chlorhexidine-alcohol ( 27 [ 3 % ] patients vs seven [ 1 % ] with povidone iodine-alcohol ; p=0·0017 ) and led to chlorhexidine discontinuation in two patients . INTERPRETATION For skin antisepsis , chlorhexidine-alcohol provides greater protection against short-term catheter-related infections than does povidone iodine-alcohol and should be included in all bundles for prevention of intravascular catheter-related infections . FUNDING University Hospital of Poitiers , CareFusion ."
],
"offsets": [
[
0,
3058
]
]
}
] | [
{
"id": "72515",
"type": "Intervention_Pharmacological",
"text": [
"chlorhexidine-alcohol"
],
"offsets": [
[
21,
42
]
],
"normalized": []
},
{
"id": "72516",
"type": "Intervention_Pharmacological",
"text": [
"povidone iodine-alcohol"
],
"offsets": [
[
50,
73
]
],
"normalized": []
},
{
"id": "72517",
"type": "Intervention_Pharmacological",
"text": [
"chlorhexidine-alcohol"
],
"offsets": [
[
21,
42
]
],
"normalized": []
},
{
"id": "72518",
"type": "Intervention_Pharmacological",
"text": [
"povidone iodine-alcohol"
],
"offsets": [
[
50,
73
]
],
"normalized": []
},
{
"id": "72519",
"type": "Outcome_Adverse-effects",
"text": [
"incidence of catheter-related infections"
],
"offsets": [
[
1566,
1606
]
],
"normalized": []
},
{
"id": "72520",
"type": "Outcome_Adverse-effects",
"text": [
"incidence of catheter-related infections"
],
"offsets": [
[
1566,
1606
]
],
"normalized": []
},
{
"id": "72521",
"type": "Outcome_Adverse-effects",
"text": [
"systemic adverse"
],
"offsets": [
[
2462,
2478
]
],
"normalized": []
},
{
"id": "72522",
"type": "Participant_Condition",
"text": [
"intravascular-catheter-related infection"
],
"offsets": [
[
128,
168
]
],
"normalized": []
},
{
"id": "72523",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
832,
838
]
],
"normalized": []
},
{
"id": "72524",
"type": "Participant_Age",
"text": [
"age ≥18 years )"
],
"offsets": [
[
841,
856
]
],
"normalized": []
},
{
"id": "72525",
"type": "Participant_Condition",
"text": [
"central-venous , haemodialysis , or arterial catheters"
],
"offsets": [
[
937,
991
]
],
"normalized": []
},
{
"id": "72526",
"type": "Participant_Sample-size",
"text": [
"2546 patients"
],
"offsets": [
[
1863,
1876
]
],
"normalized": []
},
{
"id": "72527",
"type": "Participant_Sample-size",
"text": [
"1181 patients"
],
"offsets": [
[
1942,
1955
]
],
"normalized": []
},
{
"id": "72528",
"type": "Participant_Sample-size",
"text": [
"2547 catheters"
],
"offsets": [
[
1958,
1972
]
],
"normalized": []
}
] | [] | [] | [] |
72529 | 26398887 | [
{
"id": "72530",
"type": "document",
"text": [
"Effect of Ezetimibe on LDL-C Lowering and Atherogenic Lipoprotein Profiles in Type 2 Diabetic Patients Poorly Controlled by Statins . BACKGROUND There exists a subpopulation of T2DM in whom first-line doses of statin are insufficient for optimally reducing LDL-C , representing a major risk of CVD . The RESEARCH study focuses on LDL-C reduction in this population along with modifications of the lipid profiles leading to residual risks . METHODS Lipid changes were assessed in a randomized , multicenter , 12-week , open-label study comparing a high-potency statin ( 10mg of atorvastatin or 1mg of pitavastatin ) plus ezetimibe ( EAT : n = 53 ) with a double dose of statin ( 20mg of atorvastatin or 2mg of pitavastatin ) ( DST : n = 56 ) in DM subjects who had failed to achieve the optimal LDL-C targets . Lipid variables were compared with a primary focus on LDL-C and with secondary focuses on the percentage of patients who reached the LDL-C targets and changes in the levels of RLP-C ( remnant like particle cholesterol ) and sd-LDL-C , two characteristic atherogenic risks of DM . RESULTS The reduction of LDL-C ( % ) , the primary endpoint , differed significantly between the two groups ( -24.6 in EAT vs. -10.9 in DST ) . In the analyses of the secondary endpoints , EAT treatment brought about significantly larger reductions in sd-LDL-C ( -20.5 vs. -3.7 ) and RLP-C ( -19.7 vs. +5.5 ) . In total , 89.4 % of the patients receiving EAT reached the optimized treatment goal compared to 51.0 % of the patients receiving DST . The changes in TC ( -16.3 vs. -6.3 ) and non-HDL-C ( -20.7 vs. -8.3 ) differed significantly between the two groups . CONCLUSION Ezetimibe added to high-potency statin ( 10 mg of atorvastatin or 1 mg of pitavastatin ) was more effective than the intensified-dose statin ( 20 mg of atorvastatin or 2 mg of pitavastatin ) treatment not only in helping T2DM patients attain more LDL-C reduction , but also in improving their atherogenic lipid profiles , including their levels of sd-LDL-C and RLP-C. We thus recommend the addition of ezetimibe to high-potency statin as a first line strategy for T2DM patients with insufficient statin response . TRIAL REGISTRATION The UMIN Clinical Trials Registry UMIN000002593 ."
],
"offsets": [
[
0,
2248
]
]
}
] | [
{
"id": "72531",
"type": "Intervention_Pharmacological",
"text": [
"Ezetimibe"
],
"offsets": [
[
10,
19
]
],
"normalized": []
},
{
"id": "72532",
"type": "Intervention_Pharmacological",
"text": [
"high-potency statin ( 10mg of atorvastatin or 1mg of pitavastatin )"
],
"offsets": [
[
547,
614
]
],
"normalized": []
},
{
"id": "72533",
"type": "Intervention_Pharmacological",
"text": [
"ezetimibe"
],
"offsets": [
[
620,
629
]
],
"normalized": []
},
{
"id": "72534",
"type": "Intervention_Pharmacological",
"text": [
"statin"
],
"offsets": [
[
210,
216
]
],
"normalized": []
},
{
"id": "72535",
"type": "Intervention_Pharmacological",
"text": [
"atorvastatin"
],
"offsets": [
[
577,
589
]
],
"normalized": []
},
{
"id": "72536",
"type": "Intervention_Pharmacological",
"text": [
"pitavastatin"
],
"offsets": [
[
600,
612
]
],
"normalized": []
},
{
"id": "72537",
"type": "Intervention_Pharmacological",
"text": [
"DST"
],
"offsets": [
[
726,
729
]
],
"normalized": []
},
{
"id": "72538",
"type": "Intervention_Pharmacological",
"text": [
"Ezetimibe"
],
"offsets": [
[
10,
19
]
],
"normalized": []
},
{
"id": "72539",
"type": "Intervention_Pharmacological",
"text": [
"statin"
],
"offsets": [
[
210,
216
]
],
"normalized": []
},
{
"id": "72540",
"type": "Intervention_Pharmacological",
"text": [
"atorvastatin"
],
"offsets": [
[
577,
589
]
],
"normalized": []
},
{
"id": "72541",
"type": "Intervention_Pharmacological",
"text": [
"pitavastatin"
],
"offsets": [
[
600,
612
]
],
"normalized": []
},
{
"id": "72542",
"type": "Intervention_Pharmacological",
"text": [
"statin"
],
"offsets": [
[
210,
216
]
],
"normalized": []
},
{
"id": "72543",
"type": "Intervention_Pharmacological",
"text": [
"atorvastatin"
],
"offsets": [
[
577,
589
]
],
"normalized": []
},
{
"id": "72544",
"type": "Intervention_Pharmacological",
"text": [
"pitavastatin"
],
"offsets": [
[
600,
612
]
],
"normalized": []
},
{
"id": "72545",
"type": "Outcome_Physical",
"text": [
"LDL-C Lowering"
],
"offsets": [
[
23,
37
]
],
"normalized": []
},
{
"id": "72546",
"type": "Outcome_Physical",
"text": [
"Atherogenic Lipoprotein Profiles"
],
"offsets": [
[
42,
74
]
],
"normalized": []
},
{
"id": "72547",
"type": "Outcome_Physical",
"text": [
"LDL-C"
],
"offsets": [
[
23,
28
]
],
"normalized": []
},
{
"id": "72548",
"type": "Outcome_Physical",
"text": [
"LDL-C"
],
"offsets": [
[
23,
28
]
],
"normalized": []
},
{
"id": "72549",
"type": "Outcome_Physical",
"text": [
"Lipid changes"
],
"offsets": [
[
448,
461
]
],
"normalized": []
},
{
"id": "72550",
"type": "Outcome_Physical",
"text": [
"Lipid variables"
],
"offsets": [
[
810,
825
]
],
"normalized": []
},
{
"id": "72551",
"type": "Outcome_Physical",
"text": [
"LDL-C"
],
"offsets": [
[
23,
28
]
],
"normalized": []
},
{
"id": "72552",
"type": "Outcome_Physical",
"text": [
"LDL-C"
],
"offsets": [
[
23,
28
]
],
"normalized": []
},
{
"id": "72553",
"type": "Outcome_Physical",
"text": [
"levels of RLP-C"
],
"offsets": [
[
976,
991
]
],
"normalized": []
},
{
"id": "72554",
"type": "Outcome_Physical",
"text": [
"sd-LDL-C"
],
"offsets": [
[
1034,
1042
]
],
"normalized": []
},
{
"id": "72555",
"type": "Outcome_Physical",
"text": [
"reduction of LDL-C"
],
"offsets": [
[
1102,
1120
]
],
"normalized": []
},
{
"id": "72556",
"type": "Outcome_Physical",
"text": [
"sd-LDL-C"
],
"offsets": [
[
1034,
1042
]
],
"normalized": []
},
{
"id": "72557",
"type": "Outcome_Physical",
"text": [
"RLP-C"
],
"offsets": [
[
986,
991
]
],
"normalized": []
},
{
"id": "72558",
"type": "Outcome_Physical",
"text": [
"TC"
],
"offsets": [
[
1552,
1554
]
],
"normalized": []
},
{
"id": "72559",
"type": "Outcome_Physical",
"text": [
"non-HDL-C"
],
"offsets": [
[
1578,
1587
]
],
"normalized": []
},
{
"id": "72560",
"type": "Outcome_Physical",
"text": [
"LDL-C reduction"
],
"offsets": [
[
330,
345
]
],
"normalized": []
},
{
"id": "72561",
"type": "Outcome_Physical",
"text": [
"atherogenic lipid profiles"
],
"offsets": [
[
1959,
1985
]
],
"normalized": []
},
{
"id": "72562",
"type": "Outcome_Physical",
"text": [
"sd-LDL-C"
],
"offsets": [
[
1034,
1042
]
],
"normalized": []
},
{
"id": "72563",
"type": "Outcome_Physical",
"text": [
"RLP-C."
],
"offsets": [
[
2027,
2033
]
],
"normalized": []
},
{
"id": "72564",
"type": "Participant_Condition",
"text": [
"Diabetic"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "72565",
"type": "Participant_Condition",
"text": [
"DM subjects who had failed to achieve the optimal LDL-C targets"
],
"offsets": [
[
744,
807
]
],
"normalized": []
},
{
"id": "72566",
"type": "Participant_Condition",
"text": [
"T2DM patients with insufficient statin response ."
],
"offsets": [
[
2130,
2179
]
],
"normalized": []
}
] | [] | [] | [] |
72567 | 2642730 | [
{
"id": "72568",
"type": "document",
"text": [
"A controlled trial of extended radical versus radical mastectomy . Ten-year results . In view of increasing debate over possible benefit of more complete surgery compared to conservative procedures , a randomized controlled trial contrasting the then standard Halsted radical ( RDL ) operation with the more complete extended radical ( EXT ) mastectomy was initiated in 1973 . Between November 1973 and July 1982 , 123 women younger than 70 years of age and at clinical Stages I and II were enrolled . Of the total series , 112 were treated by the same surgeon and confirmed pathologically as having invasive mammary carcinoma . In this more homogeneous subgroup , the 10-year survival rates ( and standard errors ) were for RDL , 60 % ( +/- 7 % ) and for EXT , 74 % ( +/- 6 % ) ( P value for comparison of survival curves = 0.13 ) . In patients from this subgroup with central-medial tumors , comprising 62 % of the total , survival after RDL at 10 years was 60 % ( +/- 8 % ) , and after EXT 86 % ( +/- 6 % ) ( P = 0.025 ) . In the remaining patients with lateral tumors , survival rates were unaffected by treatment : 58 % ( +/- 13 % ) and 56 % ( +/- 11 % ) , respectively ( P = 0.62 ) . Comparison of a nonrandomized series of 266 RDL and 124 EXT patients treated between 1960 and 1978 found differences consistent with those of the randomized study , although not statistically significant ."
],
"offsets": [
[
0,
1395
]
]
}
] | [
{
"id": "72569",
"type": "Intervention_Surgical",
"text": [
"extended radical"
],
"offsets": [
[
22,
38
]
],
"normalized": []
},
{
"id": "72570",
"type": "Intervention_Surgical",
"text": [
"radical mastectomy"
],
"offsets": [
[
46,
64
]
],
"normalized": []
},
{
"id": "72571",
"type": "Intervention_Surgical",
"text": [
"standard Halsted radical ( RDL ) operation"
],
"offsets": [
[
251,
293
]
],
"normalized": []
},
{
"id": "72572",
"type": "Intervention_Surgical",
"text": [
"complete extended radical ( EXT ) mastectomy"
],
"offsets": [
[
308,
352
]
],
"normalized": []
},
{
"id": "72573",
"type": "Outcome_Mortality",
"text": [
"10-year survival rates"
],
"offsets": [
[
669,
691
]
],
"normalized": []
},
{
"id": "72574",
"type": "Outcome_Mortality",
"text": [
"survival"
],
"offsets": [
[
677,
685
]
],
"normalized": []
},
{
"id": "72575",
"type": "Outcome_Mortality",
"text": [
"survival rates"
],
"offsets": [
[
677,
691
]
],
"normalized": []
},
{
"id": "72576",
"type": "Participant_Sample-size",
"text": [
"123"
],
"offsets": [
[
415,
418
]
],
"normalized": []
},
{
"id": "72577",
"type": "Participant_Sex",
"text": [
"women"
],
"offsets": [
[
419,
424
]
],
"normalized": []
},
{
"id": "72578",
"type": "Participant_Age",
"text": [
"younger than 70 years of age"
],
"offsets": [
[
425,
453
]
],
"normalized": []
},
{
"id": "72579",
"type": "Participant_Condition",
"text": [
"at clinical Stages I and II"
],
"offsets": [
[
458,
485
]
],
"normalized": []
},
{
"id": "72580",
"type": "Participant_Sample-size",
"text": [
"112"
],
"offsets": [
[
524,
527
]
],
"normalized": []
},
{
"id": "72581",
"type": "Participant_Condition",
"text": [
"invasive mammary carcinoma"
],
"offsets": [
[
600,
626
]
],
"normalized": []
},
{
"id": "72582",
"type": "Participant_Condition",
"text": [
"lateral tumors"
],
"offsets": [
[
1057,
1071
]
],
"normalized": []
}
] | [] | [] | [] |
72583 | 26442399 | [
{
"id": "72584",
"type": "document",
"text": [
"DESFLURANE COMPARED TO SEVOFLURANE FOR CIRRHOTIC PATIENTS UNDERGOING MAJOR LIVER RESECTION . A RANDOMIZED CONTROL STUDY . BACKGROUND Major liver resection is associated with haemodynamic , hepatic and renal changes as a result of the procedure . AIM To compare Desflurane ( D ) versus Sevoflurane ( S ) on hepatic , renal functions , haemodynamics and perioperative course for cirrhotic patients undergoing major liver resection . PATIENTS AND METHODS A prospective randomized control study with 50 patients ( Child A ) ( D , n = 25 and S , n = 25 ) . End tidal D or S adjusted with Entropy ( 40-60 ) . Haemodynamics monitored with invasive blood pressure and trans-oesophageal Doppler ( TED ) . Liver and kidney function tests , blood Glutathione-S-transferase ( GST ) , urinary microalbuminuria ( Microalb ) were assayed . Extubation time and anaesthetic consumption were recorded . RESULTS Systemic vascular resistance ( SVR ) post-resection and stroke volume of D vs S were 835.04 ± 12.02 vs 778.16 ± 11.97 dyn.sec.cm ( -5 ) , P < 0.01 , and 85.72 ± 2.95 vs 76.16 ± 6.52 ml , P < 0.01 respectively . Doppler corrected flow time ( FTc ) between groups were comparable ( P > 0.05 ) . No difference post-operatively regarding hepatic and renal functions , and urine Microalb ( 14.76 ± 3.95 vs l4.24 ± 8.65 µg/ml , P = 0.78 ) , but a statistically difference was found with GST ( 0.046 ± [ symbols : see text ] , vs 0.043 ± [ symbols : see text ] IU/ml , P < 0.01 ) . Despite a higher D consumption ( 73 ± 17 vs 64 ± 22 ml , P = 0.102 ) , cost in Egyptian pounds ( LE ) was lower with D ( 141.14 ± 32.90 vs 320.60 ± 114.01 , LE , P < 0.01 ) . Extubation time and ICU stay with D vS ( 4.52 ± 2 vs 7.72 ± 2 min , P < 0.01 ) and ( 1.40 0.50 vs 1.64 ± 0.48 , days P = 0.09 ) respectively . CONCLUSION Neither D nor S were clinically superior to the other with respect to liver and kidneys functions , but D was found to preserve better the haemodynamic parameters and enhance recovery at a lower cost ."
],
"offsets": [
[
0,
1998
]
]
}
] | [
{
"id": "72585",
"type": "Intervention_Pharmacological",
"text": [
"Desflurane ( D ) versus Sevoflurane ( S )"
],
"offsets": [
[
261,
302
]
],
"normalized": []
},
{
"id": "72586",
"type": "Outcome_Physical",
"text": [
"hepatic , renal functions , haemodynamics and perioperative course"
],
"offsets": [
[
306,
372
]
],
"normalized": []
},
{
"id": "72587",
"type": "Outcome_Physical",
"text": [
"End tidal D or S adjusted with Entropy"
],
"offsets": [
[
552,
590
]
],
"normalized": []
},
{
"id": "72588",
"type": "Outcome_Physical",
"text": [
"Haemodynamics monitored with invasive blood pressure and trans-oesophageal Doppler ( TED ) . Liver and kidney function tests , blood Glutathione-S-transferase ( GST ) , urinary microalbuminuria ( Microalb ) were assayed ."
],
"offsets": [
[
603,
824
]
],
"normalized": []
},
{
"id": "72589",
"type": "Outcome_Other",
"text": [
"Extubation time"
],
"offsets": [
[
825,
840
]
],
"normalized": []
},
{
"id": "72590",
"type": "Outcome_Other",
"text": [
"anaesthetic consumption were recorded"
],
"offsets": [
[
845,
882
]
],
"normalized": []
},
{
"id": "72591",
"type": "Outcome_Physical",
"text": [
"Systemic vascular resistance ( SVR ) post-resection and stroke volume"
],
"offsets": [
[
893,
962
]
],
"normalized": []
},
{
"id": "72592",
"type": "Participant_Condition",
"text": [
"CIRRHOTIC PATIENTS UNDERGOING MAJOR LIVER RESECTION ."
],
"offsets": [
[
39,
92
]
],
"normalized": []
},
{
"id": "72593",
"type": "Participant_Condition",
"text": [
"cirrhotic patients undergoing major liver resection"
],
"offsets": [
[
377,
428
]
],
"normalized": []
},
{
"id": "72594",
"type": "Participant_Sample-size",
"text": [
"50 patients"
],
"offsets": [
[
496,
507
]
],
"normalized": []
},
{
"id": "72595",
"type": "Participant_Age",
"text": [
"Child A"
],
"offsets": [
[
510,
517
]
],
"normalized": []
}
] | [] | [] | [] |
72596 | 2644391 | [
{
"id": "72597",
"type": "document",
"text": [
"The effectiveness of single-dose metronidazole therapy for patients and their partners with bacterial vaginosis . A randomized , placebo-controlled , double-blind clinical trial was performed to test the hypothesis that a 2-g single dose of metronidazole for male partners of women with bacterial vaginosis was more effective than placebo in improving cure rate and decreasing recurrence rate . In addition , the effectiveness of a 2-g single dose of metronidazole was compared with a seven-day course of 500 mg of metronidazole twice a day in patients with bacterial vaginosis . Statistically significant benefits of partner treatment were noted in the initial cure rate by Gram-stained smear criteria ( P less than .01 ) and in percentage of women with symptoms eight weeks after initiating therapy ( P less than .05 ) . The seven-day course of metronidazole was superior to the single-dose regimen in the percentage of patients with clue cells and the percentage of patients with a positive \" sniff \" test at the first follow-up visit ; however , differences in the initial cure rate assessed by clinical criteria and Gram-stained smear criteria were not statistically significant between the two patient treatment regimens . Recurrence rates by Gram-stained smear criteria between patient and partner treatment groups at five and eight weeks after initiation of treatment were also not significantly different between the two patient regimens . Single-dose metronidazole treatment of the sexual partner of women with bacterial vaginosis improves initial bacterial vaginosis cure rates . The seven-day course of metronidazole was not found by statistical analysis to be significantly superior to single-dose therapy when considering initial cure rates by clinical or Gram-stained smear criteria or recurrence rates . ( ABSTRACT TRUNCATED AT 250 WORDS )"
],
"offsets": [
[
0,
1855
]
]
}
] | [
{
"id": "72598",
"type": "Intervention_Pharmacological",
"text": [
"metronidazole"
],
"offsets": [
[
33,
46
]
],
"normalized": []
},
{
"id": "72599",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
129,
147
]
],
"normalized": []
},
{
"id": "72600",
"type": "Intervention_Pharmacological",
"text": [
"metronidazole"
],
"offsets": [
[
33,
46
]
],
"normalized": []
},
{
"id": "72601",
"type": "Intervention_Pharmacological",
"text": [
"single dose of metronidazole"
],
"offsets": [
[
226,
254
]
],
"normalized": []
},
{
"id": "72602",
"type": "Intervention_Pharmacological",
"text": [
"seven-day course of 500 mg of metronidazole"
],
"offsets": [
[
485,
528
]
],
"normalized": []
},
{
"id": "72603",
"type": "Intervention_Pharmacological",
"text": [
"metronidazole"
],
"offsets": [
[
33,
46
]
],
"normalized": []
},
{
"id": "72604",
"type": "Outcome_Physical",
"text": [
"initial cure rate assessed by clinical criteria and Gram-stained smear criteria"
],
"offsets": [
[
1069,
1148
]
],
"normalized": []
},
{
"id": "72605",
"type": "Outcome_Physical",
"text": [
"Recurrence rates by Gram-stained smear criteria"
],
"offsets": [
[
1229,
1276
]
],
"normalized": []
},
{
"id": "72606",
"type": "Outcome_Physical",
"text": [
"bacterial vaginosis cure rates"
],
"offsets": [
[
1558,
1588
]
],
"normalized": []
}
] | [] | [] | [] |
72607 | 26446239 | [
{
"id": "72608",
"type": "document",
"text": [
"U.S. Food and Drug Administration Approval Summary : Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy . UNLABELLED On December 12 , 2014 , the U.S. Food and Drug Administration ( FDA ) approved ramucirumab for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) with disease progression on or after platinum-based chemotherapy . Patients with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab . This approval was based on an improvement in overall survival ( OS ) with an acceptable toxicity profile in a randomized , multicenter , double-blinded , placebo-controlled trial of 1,253 patients with metastatic NSCLC previously treated with a platinum-based combination therapy . Patients were randomized 1:1 to receive either ramucirumab in combination with docetaxel or placebo in combination with docetaxel . The primary endpoint was OS . Patients who received ramucirumab in combination with docetaxel had improved OS ( hazard ratio [ HR ] : 0.86 ; 95 % confidence interval [ CI ] : 0.75 , 0.98 ) . Median OS was 10.5 months on the ramucirumab plus docetaxel arm versus 9.1 months on the placebo plus docetaxel arm . The most frequent ( ≥ 30 % ) adverse reactions in ramucirumab-treated patients were fatigue , neutropenia , and diarrhea . The most frequent ( ≥ 5 % ) grade 3 and 4 adverse reactions in the ramucirumab arm were fatigue , neutropenia , febrile neutropenia , leukopenia , and hypertension . IMPLICATIONS FOR PRACTICE This report presents key information on the U.S. Food and Drug Administration approval of ramucirumab , a monoclonal antibody targeting vascular endothelial growth factor receptor-2 , given in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy . This report specifically addresses the issues of safety in patients with squamous cell tumors , effect of treatment in elderly patients , and uncertainties regarding effects in patients with tumors harboring epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations ."
],
"offsets": [
[
0,
2400
]
]
}
] | [
{
"id": "72609",
"type": "Intervention_Pharmacological",
"text": [
"Ramucirumab"
],
"offsets": [
[
53,
64
]
],
"normalized": []
},
{
"id": "72610",
"type": "Intervention_Pharmacological",
"text": [
"ramucirumab"
],
"offsets": [
[
286,
297
]
],
"normalized": []
},
{
"id": "72611",
"type": "Intervention_Pharmacological",
"text": [
"docetaxel"
],
"offsets": [
[
326,
335
]
],
"normalized": []
},
{
"id": "72612",
"type": "Intervention_Pharmacological",
"text": [
"ramucirumab ."
],
"offsets": [
[
686,
699
]
],
"normalized": []
},
{
"id": "72613",
"type": "Intervention_Pharmacological",
"text": [
"ramucirumab in combination with docetaxel"
],
"offsets": [
[
1029,
1070
]
],
"normalized": []
},
{
"id": "72614",
"type": "Intervention_Control",
"text": [
"placebo"
],
"offsets": [
[
854,
861
]
],
"normalized": []
},
{
"id": "72615",
"type": "Intervention_Pharmacological",
"text": [
"with docetaxel"
],
"offsets": [
[
321,
335
]
],
"normalized": []
},
{
"id": "72616",
"type": "Outcome_Mortality",
"text": [
"OS ."
],
"offsets": [
[
1139,
1143
]
],
"normalized": []
},
{
"id": "72617",
"type": "Outcome_Mortality",
"text": [
"improved OS"
],
"offsets": [
[
1212,
1223
]
],
"normalized": []
},
{
"id": "72618",
"type": "Outcome_Mortality",
"text": [
"Median OS"
],
"offsets": [
[
1305,
1314
]
],
"normalized": []
},
{
"id": "72619",
"type": "Outcome_Adverse-effects",
"text": [
"fatigue , neutropenia , and diarrhea"
],
"offsets": [
[
1507,
1543
]
],
"normalized": []
},
{
"id": "72620",
"type": "Outcome_Adverse-effects",
"text": [
"neutropenia , febrile neutropenia , leukopenia , and hypertension"
],
"offsets": [
[
1644,
1709
]
],
"normalized": []
},
{
"id": "72621",
"type": "Participant_Condition",
"text": [
"metastatic non-small cell lung cancer ( NSCLC )"
],
"offsets": [
[
371,
418
]
],
"normalized": []
},
{
"id": "72622",
"type": "Participant_Condition",
"text": [
"epidermal growth factor receptor"
],
"offsets": [
[
500,
532
]
],
"normalized": []
},
{
"id": "72623",
"type": "Participant_Condition",
"text": [
"anaplastic lymphoma kinase genomic tumor aberrations"
],
"offsets": [
[
536,
588
]
],
"normalized": []
},
{
"id": "72624",
"type": "Participant_Sample-size",
"text": [
"1,253 patients"
],
"offsets": [
[
882,
896
]
],
"normalized": []
},
{
"id": "72625",
"type": "Participant_Condition",
"text": [
"metastatic non-small cell lung cancer"
],
"offsets": [
[
371,
408
]
],
"normalized": []
},
{
"id": "72626",
"type": "Participant_Condition",
"text": [
"squamous cell tumors"
],
"offsets": [
[
2175,
2195
]
],
"normalized": []
},
{
"id": "72627",
"type": "Participant_Age",
"text": [
"treatment in elderly patients"
],
"offsets": [
[
2208,
2237
]
],
"normalized": []
},
{
"id": "72628",
"type": "Participant_Condition",
"text": [
"tumors harboring epidermal growth factor receptor"
],
"offsets": [
[
2293,
2342
]
],
"normalized": []
}
] | [] | [] | [] |
72629 | 26448791 | [
{
"id": "72630",
"type": "document",
"text": [
"Computer Decision Support Changes Physician Practice But Not Knowledge Regarding Autism Spectrum Disorders . OBJECTIVE To examine whether adding an autism module promoting adherence to clinical guidelines to an existing computer decision support system ( CDSS ) changed physician knowledge and self-reported clinical practice . METHODS The CHICA ( Child Health Improvement through Computer Automation ) system , a CDSS , was enhanced with a module to improve management of autism in 2 of the 4 community pediatric clinics using the system . We examined the knowledge and beliefs of pediatric users using cross-sectional surveys administered at 3 time points ( baseline , 12 months and 24 months post-implementation ) between November 2010 and January 2013 . Surveys measured knowledge , beliefs and self-reported practice patterns related to autism . RESULTS A total of 45 , 39 , and 42 pediatricians responded at each time point , respectively , a 95-100 % response rate . Respondents ' knowledge of autism and perception of role for diagnosis did not vary between control and intervention groups either at baseline or any of the two post-intervention time points . At baseline , there was no difference between these groups in rates in the routine use of parent-rated screening instruments for autism . However , by 12 and 24 months post-implementation there was a significant difference between intervention and control clinics in terms of the intervention clinics consistently screening eligible patients with a validated autism tool . Physicians at all clinics reported ongoing challenges to community resources for further work-up and treatment related to autism . CONCLUSIONS A CDSS module to improve primary care management of ASD in pediatric practice led to significant improvements in physician-reported use of validated screening tools to screen for ASDs . However it did not lead to corresponding changes in physician knowledge or attitudes ."
],
"offsets": [
[
0,
1955
]
]
}
] | [
{
"id": "72631",
"type": "Intervention_Educational",
"text": [
"Computer Decision Support"
],
"offsets": [
[
0,
25
]
],
"normalized": []
},
{
"id": "72632",
"type": "Intervention_Educational",
"text": [
"computer decision support system"
],
"offsets": [
[
220,
252
]
],
"normalized": []
},
{
"id": "72633",
"type": "Intervention_Educational",
"text": [
"CHICA ( Child Health Improvement through Computer Automation ) system"
],
"offsets": [
[
340,
409
]
],
"normalized": []
},
{
"id": "72634",
"type": "Intervention_Educational",
"text": [
"CDSS"
],
"offsets": [
[
255,
259
]
],
"normalized": []
},
{
"id": "72635",
"type": "Intervention_Educational",
"text": [
"CDSS"
],
"offsets": [
[
255,
259
]
],
"normalized": []
},
{
"id": "72636",
"type": "Outcome_Mental",
"text": [
"Practice"
],
"offsets": [
[
44,
52
]
],
"normalized": []
},
{
"id": "72637",
"type": "Outcome_Mental",
"text": [
"Knowledge"
],
"offsets": [
[
61,
70
]
],
"normalized": []
},
{
"id": "72638",
"type": "Outcome_Physical",
"text": [
"management of autism"
],
"offsets": [
[
459,
479
]
],
"normalized": []
},
{
"id": "72639",
"type": "Outcome_Other",
"text": [
"Surveys"
],
"offsets": [
[
758,
765
]
],
"normalized": []
},
{
"id": "72640",
"type": "Outcome_Physical",
"text": [
"knowledge"
],
"offsets": [
[
280,
289
]
],
"normalized": []
},
{
"id": "72641",
"type": "Outcome_Physical",
"text": [
"beliefs and self-reported practice patterns related to autism"
],
"offsets": [
[
787,
848
]
],
"normalized": []
},
{
"id": "72642",
"type": "Outcome_Physical",
"text": [
"knowledge of autism and perception of role for diagnosis"
],
"offsets": [
[
988,
1044
]
],
"normalized": []
},
{
"id": "72643",
"type": "Outcome_Mental",
"text": [
"rates in the routine use of parent-rated screening instruments"
],
"offsets": [
[
1229,
1291
]
],
"normalized": []
},
{
"id": "72644",
"type": "Outcome_Physical",
"text": [
"physician-reported use of validated screening tools"
],
"offsets": [
[
1796,
1847
]
],
"normalized": []
},
{
"id": "72645",
"type": "Outcome_Physical",
"text": [
"physician knowledge or attitudes"
],
"offsets": [
[
1921,
1953
]
],
"normalized": []
},
{
"id": "72646",
"type": "Participant_Condition",
"text": [
"Physician Practice"
],
"offsets": [
[
34,
52
]
],
"normalized": []
},
{
"id": "72647",
"type": "Participant_Condition",
"text": [
"Autism Spectrum Disorders ."
],
"offsets": [
[
81,
108
]
],
"normalized": []
},
{
"id": "72648",
"type": "Participant_Condition",
"text": [
"CHICA ( Child Health Improvement through Computer Automation"
],
"offsets": [
[
340,
400
]
],
"normalized": []
},
{
"id": "72649",
"type": "Participant_Condition",
"text": [
"autism"
],
"offsets": [
[
148,
154
]
],
"normalized": []
},
{
"id": "72650",
"type": "Participant_Condition",
"text": [
"pediatric users"
],
"offsets": [
[
582,
597
]
],
"normalized": []
},
{
"id": "72651",
"type": "Participant_Sample-size",
"text": [
"45"
],
"offsets": [
[
870,
872
]
],
"normalized": []
},
{
"id": "72652",
"type": "Participant_Sample-size",
"text": [
"39"
],
"offsets": [
[
875,
877
]
],
"normalized": []
},
{
"id": "72653",
"type": "Participant_Sample-size",
"text": [
"42"
],
"offsets": [
[
884,
886
]
],
"normalized": []
}
] | [] | [] | [] |
72654 | 26449739 | [
{
"id": "72655",
"type": "document",
"text": [
"Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma . Results of the HD2002 prospective multicentre randomized phase III trial . In the multicentre prospective randomized HD2002 trial , rituximab maintenance therapy ( 375 mg/m ( 2 ) every 3 months for 2 years ) versus observation was evaluated for CD20 ( + ) B-cell lymphoma . Out of 321 patients [ 161 randomized to the treatment group ( TG ) , 160 to the observation group ( OG ) ] , 295 data sets were evaluable for statistical analysis . Estimated 5-year relapse-free survival ( RFS ) was 81 % in the TG and 70 % in the OG ( logrank test , P = 0·047 ) . In the diffuse large B-cell lymphoma ( DLBCL ) subgroup ( n = 152 ) , 5-year RFS was excellent , at 87 % in the TG and 84 % in the OG ( logrank test , P = 0·35 ) . Of note , only in male patients of the DLBCL subgroup was RFS significantly superior in the TG in comparison to the OG ( 5-year RFS : 88 % vs. 74 % ; logrank test , P = 0·05 ) . Cox regression analysis showed a significant interaction between treatment and gender regarding overall survival ( OS ) ( P = 0·006 ) and RFS ( P = 0·02 ) , with a lower hazard in females than males in the OG [ OS : hazard ratio ( HR ) ( female : male ) = 0·11 ; 95 % confidence interval ( CI ) = 0·00-1·03 ; RFS : HR ( female : male ) = 0·27 ; 95 % CI = 0·05-0·97 ] , and no significant differences between males and females in the TG . We conclude that Rituximab maintenance therapy improves survival in male patients with DLBCL ."
],
"offsets": [
[
0,
1523
]
]
}
] | [
{
"id": "72656",
"type": "Intervention_Pharmacological",
"text": [
"Rituximab"
],
"offsets": [
[
0,
9
]
],
"normalized": []
},
{
"id": "72657",
"type": "Intervention_Pharmacological",
"text": [
"rituximab maintenance therapy"
],
"offsets": [
[
226,
255
]
],
"normalized": []
},
{
"id": "72658",
"type": "Intervention_Control",
"text": [
"observation"
],
"offsets": [
[
309,
320
]
],
"normalized": []
},
{
"id": "72659",
"type": "Outcome_Mortality",
"text": [
"5-year relapse-free survival ( RFS )"
],
"offsets": [
[
543,
579
]
],
"normalized": []
},
{
"id": "72660",
"type": "Participant_Sex",
"text": [
"male"
],
"offsets": [
[
43,
47
]
],
"normalized": []
},
{
"id": "72661",
"type": "Participant_Condition",
"text": [
"diffuse large B-cell lymphoma"
],
"offsets": [
[
62,
91
]
],
"normalized": []
},
{
"id": "72662",
"type": "Participant_Sample-size",
"text": [
"321 patients"
],
"offsets": [
[
375,
387
]
],
"normalized": []
},
{
"id": "72663",
"type": "Participant_Sample-size",
"text": [
"161 randomized"
],
"offsets": [
[
390,
404
]
],
"normalized": []
},
{
"id": "72664",
"type": "Participant_Sample-size",
"text": [
"160"
],
"offsets": [
[
437,
440
]
],
"normalized": []
},
{
"id": "72665",
"type": "Participant_Sex",
"text": [
"male"
],
"offsets": [
[
43,
47
]
],
"normalized": []
},
{
"id": "72666",
"type": "Participant_Sex",
"text": [
"male"
],
"offsets": [
[
43,
47
]
],
"normalized": []
}
] | [] | [] | [] |
72667 | 26449882 | [
{
"id": "72668",
"type": "document",
"text": [
"The neuropeptide oxytocin modulates consumer brand relationships . Each year , companies invest billions of dollars into marketing activities to embellish brands as valuable relationship partners assuming that consumer brand relationships ( CBRs ) and interpersonal relationships rest upon the same neurobiological underpinnings . Given the crucial role of the neuropeptide oxytocin ( OXT ) in social bonding , this study tests whether OXT-based mechanisms also determine the bond between consumers and brands . We conducted a randomized , placebo-controlled study involving 101 subjects and analyzed the effect of intranasal OXT on consumers ' attribution of relationship qualities to brands , brands paired with human celebrity endorsers , and familiar persons . OXT indeed promoted the attribution of relationship qualities not only in the case of social and semi-social stimuli , but also brands . Intriguingly , for subjects scoring high on autistic-like traits , the effect of OXT was completely reversed , evident in even lower relationship qualities across all stimulus categories . The importance of OXT in a CBR context is further corroborated by a three-fold increase in endogenous release of OXT following exposure to one 's favorite brand and positive associations between baseline peripheral OXT concentrations and brand relationship qualities . Collectively , our findings indicate that OXT not only plays a fundamental role in developing interpersonal relationships , but also enables relationship formation with objects such as brands ."
],
"offsets": [
[
0,
1553
]
]
}
] | [
{
"id": "72669",
"type": "Intervention_Pharmacological",
"text": [
"neuropeptide oxytocin"
],
"offsets": [
[
4,
25
]
],
"normalized": []
},
{
"id": "72670",
"type": "Intervention_Pharmacological",
"text": [
"neuropeptide oxytocin ( OXT )"
],
"offsets": [
[
361,
390
]
],
"normalized": []
},
{
"id": "72671",
"type": "Intervention_Pharmacological",
"text": [
"intranasal OXT"
],
"offsets": [
[
615,
629
]
],
"normalized": []
},
{
"id": "72672",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72673",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72674",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72675",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72676",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72677",
"type": "Intervention_Pharmacological",
"text": [
"OXT"
],
"offsets": [
[
385,
388
]
],
"normalized": []
},
{
"id": "72678",
"type": "Outcome_Mental",
"text": [
"consumers ' attribution of relationship qualities to brands"
],
"offsets": [
[
633,
692
]
],
"normalized": []
},
{
"id": "72679",
"type": "Outcome_Mental",
"text": [
"attribution of relationship qualities"
],
"offsets": [
[
645,
682
]
],
"normalized": []
},
{
"id": "72680",
"type": "Outcome_Mental",
"text": [
"relationship qualities"
],
"offsets": [
[
660,
682
]
],
"normalized": []
},
{
"id": "72681",
"type": "Outcome_Mental",
"text": [
"endogenous release of OXT"
],
"offsets": [
[
1182,
1207
]
],
"normalized": []
},
{
"id": "72682",
"type": "Outcome_Mental",
"text": [
"interpersonal relationships"
],
"offsets": [
[
252,
279
]
],
"normalized": []
},
{
"id": "72683",
"type": "Participant_Sample-size",
"text": [
"101"
],
"offsets": [
[
575,
578
]
],
"normalized": []
},
{
"id": "72684",
"type": "Participant_Condition",
"text": [
"autistic-like traits"
],
"offsets": [
[
946,
966
]
],
"normalized": []
}
] | [] | [] | [] |
72685 | 26467901 | [
{
"id": "72686",
"type": "document",
"text": [
"Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis ( ACTiMuS ) : study protocol for a randomised controlled trial . BACKGROUND We have recently completed an evaluation of the safety and feasibility of intravenous delivery of autologous bone marrow in patients with progressive multiple sclerosis ( MS ) . The possibility of repair was suggested by improvement in the neurophysiological secondary outcome measure seen in all participants . The current study will examine the efficacy of intravenous delivery of autologous marrow in progressive MS . Laboratory studies performed in parallel with the clinical trial will further investigate the biology of bone marrow-derived stem cell infusion in MS , including mechanisms underlying repair . METHODS/DESIGN A prospective , randomised , double-blind , placebo-controlled , stepped wedge design will be employed at a single centre ( Bristol , UK ) . Eighty patients with progressive MS will be recruited ; 60 will have secondary progressive disease ( SPMS ) but a subset ( n = 20 ) will have primary progressive disease ( PPMS ) . Participants will be randomised to either early or late ( 1 year ) intravenous infusion of autologous , unfractionated bone marrow . The placebo intervention is infusion of autologous blood . The primary outcome measure is global evoked potential derived from multimodal evoked potentials . Secondary outcome measures include adverse event reporting , clinical ( EDSS and MSFC ) and self-assessment ( MSIS-29 ) rating scales , optical coherence tomography ( OCT ) as well as brain and spine MRI . Participants will be followed up for a further year following the final intervention . Outcomes will be analysed on an intention-to-treat basis . DISCUSSION Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis ( ACTiMuS ) is the first randomised , placebo-controlled trial of non-myeloablative autologous bone marrow-derived stem cell therapy in MS . It will determine whether bone marrow cell therapy can , as was suggested by the phase I safety study , improve conduction in multiple central nervous system pathways affected in progressive MS . Furthermore , laboratory studies performed in parallel with the clinical trial will inform our understanding of the cellular pharmacodynamics of bone marrow infusion in MS patients and the mechanisms underlying cell therapy . TRIAL REGISTRATION ISRCTN27232902 Registration date 11/09/2012 . NCT01815632 Registration date 19/03/2013 ."
],
"offsets": [
[
0,
2521
]
]
}
] | [
{
"id": "72687",
"type": "Intervention_Pharmacological",
"text": [
"bone marrow-derived Cellular Therapy"
],
"offsets": [
[
14,
50
]
],
"normalized": []
},
{
"id": "72688",
"type": "Intervention_Physical",
"text": [
"delivery of autologous bone marrow"
],
"offsets": [
[
247,
281
]
],
"normalized": []
},
{
"id": "72689",
"type": "Intervention_Pharmacological",
"text": [
"intravenous delivery of autologous marrow"
],
"offsets": [
[
520,
561
]
],
"normalized": []
},
{
"id": "72690",
"type": "Intervention_Pharmacological",
"text": [
"bone marrow-derived stem cell infusion"
],
"offsets": [
[
687,
725
]
],
"normalized": []
},
{
"id": "72691",
"type": "Intervention_Control",
"text": [
"placebo-controlled"
],
"offsets": [
[
834,
852
]
],
"normalized": []
},
{
"id": "72692",
"type": "Intervention_Pharmacological",
"text": [
"intravenous infusion of autologous , unfractionated bone marrow ."
],
"offsets": [
[
1179,
1244
]
],
"normalized": []
},
{
"id": "72693",
"type": "Intervention_Control",
"text": [
"placebo intervention"
],
"offsets": [
[
1249,
1269
]
],
"normalized": []
},
{
"id": "72694",
"type": "Intervention_Control",
"text": [
"autologous blood"
],
"offsets": [
[
1285,
1301
]
],
"normalized": []
},
{
"id": "72695",
"type": "Intervention_Pharmacological",
"text": [
"bone marrow-derived Cellular Therapy"
],
"offsets": [
[
14,
50
]
],
"normalized": []
},
{
"id": "72696",
"type": "Intervention_Pharmacological",
"text": [
"non-myeloablative autologous bone marrow-derived stem cell therapy"
],
"offsets": [
[
1917,
1983
]
],
"normalized": []
},
{
"id": "72697",
"type": "Intervention_Pharmacological",
"text": [
"bone marrow cell therapy"
],
"offsets": [
[
2018,
2042
]
],
"normalized": []
},
{
"id": "72698",
"type": "Intervention_Pharmacological",
"text": [
"cell therapy ."
],
"offsets": [
[
2399,
2413
]
],
"normalized": []
},
{
"id": "72699",
"type": "Outcome_Other",
"text": [
"safety"
],
"offsets": [
[
209,
215
]
],
"normalized": []
},
{
"id": "72700",
"type": "Outcome_Other",
"text": [
"feasibility"
],
"offsets": [
[
220,
231
]
],
"normalized": []
},
{
"id": "72701",
"type": "Outcome_Other",
"text": [
"efficacy"
],
"offsets": [
[
508,
516
]
],
"normalized": []
},
{
"id": "72702",
"type": "Outcome_Other",
"text": [
"global evoked potential derived from multimodal evoked potentials ."
],
"offsets": [
[
1335,
1402
]
],
"normalized": []
},
{
"id": "72703",
"type": "Outcome_Adverse-effects",
"text": [
"adverse event reporting"
],
"offsets": [
[
1438,
1461
]
],
"normalized": []
},
{
"id": "72704",
"type": "Outcome_Physical",
"text": [
"clinical ( EDSS and MSFC ) and self-assessment ( MSIS-29 ) rating scales"
],
"offsets": [
[
1464,
1536
]
],
"normalized": []
},
{
"id": "72705",
"type": "Outcome_Other",
"text": [
"optical coherence tomography ( OCT ) as well as brain and spine MRI"
],
"offsets": [
[
1539,
1606
]
],
"normalized": []
},
{
"id": "72706",
"type": "Participant_Condition",
"text": [
"progressive Multiple Sclerosis"
],
"offsets": [
[
54,
84
]
],
"normalized": []
},
{
"id": "72707",
"type": "Participant_Condition",
"text": [
"patients with progressive multiple sclerosis ( MS ) ."
],
"offsets": [
[
285,
338
]
],
"normalized": []
},
{
"id": "72708",
"type": "Participant_Sample-size",
"text": [
"Eighty patients"
],
"offsets": [
[
931,
946
]
],
"normalized": []
},
{
"id": "72709",
"type": "Participant_Sample-size",
"text": [
"60"
],
"offsets": [
[
987,
989
]
],
"normalized": []
},
{
"id": "72710",
"type": "Participant_Condition",
"text": [
"secondary progressive disease ( SPMS )"
],
"offsets": [
[
1000,
1038
]
],
"normalized": []
},
{
"id": "72711",
"type": "Participant_Sample-size",
"text": [
"n = 20"
],
"offsets": [
[
1054,
1060
]
],
"normalized": []
},
{
"id": "72712",
"type": "Participant_Condition",
"text": [
"primary progressive disease ( PPMS )"
],
"offsets": [
[
1073,
1109
]
],
"normalized": []
},
{
"id": "72713",
"type": "Participant_Condition",
"text": [
"progressive MS"
],
"offsets": [
[
565,
579
]
],
"normalized": []
}
] | [] | [] | [] |
72714 | 2647294 | [
{
"id": "72715",
"type": "document",
"text": [
"Randomized trial of recombinant alpha 2b-interferon with or without indomethacin in patients with metastatic malignant melanoma . alpha-Interferon has antitumor activity in a variety of malignancies but is frequently associated with unacceptable toxic side-effects . The routine use of agents potentially capable of reducing these side-effects has not been recommended out of concern for possible reductions in the therapeutic activity of interferon . We conducted a prospective randomized trial of alpha-interferon given with or without indomethacin to patients with malignant melanoma to determine what effect , if any , indomethacin might have on the toxic , immunomodulatory , and therapeutic properties of interferon in this disease . 53 patients were stratified according to performance status and randomized to receive alpha 2b-interferon , 20 million units per m2 i.v. , 5 days per week for 4 weeks followed by 10 million units per m2 s.c. three times per week , either with or without indomethacin , 25 mg orally three times a day . The overall major response rate was 13 % ( three complete responders and three partial responders among 47 evaluable patients ) and was the same on both arms . The mean maximal temperature elevation induced by interferon was significantly reduced ( from 102.1 to 100.7 , P = 0.0002 ) by indomethacin , but the incidence and severity of interferon-related fatigue , reduction in performance status , headache , depression , confusion , elevations in liver function tests , and myelosuppression were no different in either arm of the study . Indomethacin did not reduce the frequency of dose reductions for toxic side-effects and did not permit the administration of higher interferon doses . Peripheral blood natural killer activity was significantly enhanced in patients during maintenance therapy whether or not they received indomethacin . Indomethacin appeared to inhibit augmentation of natural killer activity during high dose induction therapy . Immunological changes did not correlate with response status . We conclude that indomethacin can reduce the fever associated with interferon therapy in patients with malignant melanoma without interfering with its therapeutic or chronic immunomodulatory activities . Since fever is rarely the dose-limiting toxicity of interferon , indomethacin is of marginal benefit to patients with malignant melanoma receiving interferon at the doses outlined in this study ."
],
"offsets": [
[
0,
2456
]
]
}
] | [
{
"id": "72716",
"type": "Intervention_Pharmacological",
"text": [
"recombinant alpha 2b-interferon"
],
"offsets": [
[
20,
51
]
],
"normalized": []
},
{
"id": "72717",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72718",
"type": "Intervention_Pharmacological",
"text": [
"alpha-Interferon"
],
"offsets": [
[
130,
146
]
],
"normalized": []
},
{
"id": "72719",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72720",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72721",
"type": "Intervention_Pharmacological",
"text": [
"alpha 2b-interferon"
],
"offsets": [
[
32,
51
]
],
"normalized": []
},
{
"id": "72722",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72723",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72724",
"type": "Intervention_Pharmacological",
"text": [
"Indomethacin"
],
"offsets": [
[
1582,
1594
]
],
"normalized": []
},
{
"id": "72725",
"type": "Intervention_Pharmacological",
"text": [
"Indomethacin"
],
"offsets": [
[
1582,
1594
]
],
"normalized": []
},
{
"id": "72726",
"type": "Intervention_Pharmacological",
"text": [
"indomethacin"
],
"offsets": [
[
68,
80
]
],
"normalized": []
},
{
"id": "72727",
"type": "Outcome_Adverse-effects",
"text": [
"toxic side-effects"
],
"offsets": [
[
246,
264
]
],
"normalized": []
},
{
"id": "72728",
"type": "Outcome_Adverse-effects",
"text": [
"toxic"
],
"offsets": [
[
246,
251
]
],
"normalized": []
},
{
"id": "72729",
"type": "Outcome_Other",
"text": [
"immunomodulatory"
],
"offsets": [
[
662,
678
]
],
"normalized": []
},
{
"id": "72730",
"type": "Outcome_Other",
"text": [
"therapeutic properties"
],
"offsets": [
[
685,
707
]
],
"normalized": []
},
{
"id": "72731",
"type": "Outcome_Other",
"text": [
"overall major"
],
"offsets": [
[
1046,
1059
]
],
"normalized": []
},
{
"id": "72732",
"type": "Outcome_Physical",
"text": [
"response rate"
],
"offsets": [
[
1060,
1073
]
],
"normalized": []
},
{
"id": "72733",
"type": "Outcome_Physical",
"text": [
"mean maximal temperature elevation"
],
"offsets": [
[
1206,
1240
]
],
"normalized": []
},
{
"id": "72734",
"type": "Outcome_Physical",
"text": [
"incidence and severity of interferon-related fatigue"
],
"offsets": [
[
1352,
1404
]
],
"normalized": []
},
{
"id": "72735",
"type": "Outcome_Physical",
"text": [
"reduction in performance status"
],
"offsets": [
[
1407,
1438
]
],
"normalized": []
},
{
"id": "72736",
"type": "Outcome_Physical",
"text": [
"headache"
],
"offsets": [
[
1441,
1449
]
],
"normalized": []
},
{
"id": "72737",
"type": "Outcome_Mental",
"text": [
"depression"
],
"offsets": [
[
1452,
1462
]
],
"normalized": []
},
{
"id": "72738",
"type": "Outcome_Mental",
"text": [
"confusion"
],
"offsets": [
[
1465,
1474
]
],
"normalized": []
},
{
"id": "72739",
"type": "Outcome_Physical",
"text": [
"elevations in liver function tests"
],
"offsets": [
[
1477,
1511
]
],
"normalized": []
},
{
"id": "72740",
"type": "Outcome_Physical",
"text": [
"myelosuppression"
],
"offsets": [
[
1518,
1534
]
],
"normalized": []
},
{
"id": "72741",
"type": "Outcome_Adverse-effects",
"text": [
"frequency of dose reductions for toxic side-effects"
],
"offsets": [
[
1614,
1665
]
],
"normalized": []
},
{
"id": "72742",
"type": "Outcome_Other",
"text": [
"administration of higher interferon doses"
],
"offsets": [
[
1689,
1730
]
],
"normalized": []
},
{
"id": "72743",
"type": "Outcome_Physical",
"text": [
"Peripheral blood natural killer activity"
],
"offsets": [
[
1733,
1773
]
],
"normalized": []
},
{
"id": "72744",
"type": "Outcome_Physical",
"text": [
"augmentation of natural killer activity"
],
"offsets": [
[
1917,
1956
]
],
"normalized": []
},
{
"id": "72745",
"type": "Outcome_Physical",
"text": [
"Immunological changes"
],
"offsets": [
[
1994,
2015
]
],
"normalized": []
},
{
"id": "72746",
"type": "Outcome_Physical",
"text": [
"fever"
],
"offsets": [
[
2102,
2107
]
],
"normalized": []
},
{
"id": "72747",
"type": "Outcome_Physical",
"text": [
"therapeutic or chronic immunomodulatory activities"
],
"offsets": [
[
2208,
2258
]
],
"normalized": []
},
{
"id": "72748",
"type": "Outcome_Physical",
"text": [
"fever"
],
"offsets": [
[
2102,
2107
]
],
"normalized": []
},
{
"id": "72749",
"type": "Participant_Condition",
"text": [
"metastatic malignant melanoma"
],
"offsets": [
[
98,
127
]
],
"normalized": []
},
{
"id": "72750",
"type": "Participant_Condition",
"text": [
"malignant melanoma"
],
"offsets": [
[
109,
127
]
],
"normalized": []
},
{
"id": "72751",
"type": "Participant_Sample-size",
"text": [
"53"
],
"offsets": [
[
740,
742
]
],
"normalized": []
},
{
"id": "72752",
"type": "Participant_Condition",
"text": [
"malignant melanoma"
],
"offsets": [
[
109,
127
]
],
"normalized": []
},
{
"id": "72753",
"type": "Participant_Condition",
"text": [
"malignant melanoma"
],
"offsets": [
[
109,
127
]
],
"normalized": []
}
] | [] | [] | [] |
72754 | 26485385 | [
{
"id": "72755",
"type": "document",
"text": [
"Preoperative Local Administration of Morphine as an Add-on Therapy in Patients Undergoing Surgical Removal of an Odontogenic Maxillary Cyst . A Randomized , Double-Blind Pilot Study . AIMS To evaluate whether a combination of locally administered morphine ( 1 mg ) and lidocaine as part of a multimodal analgesic approach is safe , and whether it improves pain control during the first 24 hours after odontogenic maxillary cyst removal under general anesthesia compared to local lidocaine alone . METHODS In a double-blind , sham-controlled , single-center trial , patients scheduled for surgical removal of an odontogenic maxillary cyst under general anesthesia were randomly assigned to receive a local injection of lidocaine solution with either 1 mg of morphine ( MLA group ) or with no morphine ( LA group ) . Pain management included intravenous acetaminophen ( 1 g every 6 hours ) in all patients . Upon request , the patients could additionally receive ketoprofen ( first-line additional analgesia ) or tramadol ( second-line additional analgesia ) . Pain intensity was assessed using a numeric rating scale . Primary outcome measures were ( 1 ) no need for any additional analgesic therapy and ( 2 ) time to the first rescue analgesic therapy during the first 24 hours after the surgery . RESULTS Of 48 eligible patients , 24 were allocated to the MLA group and 24 to the LA group . The necessity of additional ketoprofen therapy did not differ significantly between the groups ( 25.0 % vs 50.0 % , P=.074 ) . According to the Kaplan-Meier analysis , the probability of remaining without additional analgesic intervention was significantly higher in the MLA group ( log-rank test , P=.040 ) , but there were no significant ( P > .05 ) differences in overall and maximum pain severity between the two groups . No adverse effects of morphine were recorded . CONCLUSION Within the limitations of this study , local administration of 1 mg of morphine prior to the surgical removal of an odontogenic maxillary cyst was safe , but it did not prove to be very effective as an add-on therapy for postoperative pain control ."
],
"offsets": [
[
0,
2125
]
]
}
] | [
{
"id": "72756",
"type": "Intervention_Pharmacological",
"text": [
"Morphine"
],
"offsets": [
[
37,
45
]
],
"normalized": []
},
{
"id": "72757",
"type": "Intervention_Pharmacological",
"text": [
"morphine"
],
"offsets": [
[
247,
255
]
],
"normalized": []
},
{
"id": "72758",
"type": "Intervention_Pharmacological",
"text": [
"lidocaine"
],
"offsets": [
[
269,
278
]
],
"normalized": []
},
{
"id": "72759",
"type": "Intervention_Pharmacological",
"text": [
"lidocaine solution with either 1 mg of morphine ( MLA"
],
"offsets": [
[
718,
771
]
],
"normalized": []
},
{
"id": "72760",
"type": "Intervention_Control",
"text": [
"or with no morphine ( LA"
],
"offsets": [
[
780,
804
]
],
"normalized": []
},
{
"id": "72761",
"type": "Intervention_Pharmacological",
"text": [
"acetaminophen"
],
"offsets": [
[
852,
865
]
],
"normalized": []
},
{
"id": "72762",
"type": "Intervention_Pharmacological",
"text": [
"ketoprofen"
],
"offsets": [
[
961,
971
]
],
"normalized": []
},
{
"id": "72763",
"type": "Intervention_Pharmacological",
"text": [
"or tramadol"
],
"offsets": [
[
1008,
1019
]
],
"normalized": []
},
{
"id": "72764",
"type": "Intervention_Pharmacological",
"text": [
"ketoprofen"
],
"offsets": [
[
961,
971
]
],
"normalized": []
},
{
"id": "72765",
"type": "Intervention_Pharmacological",
"text": [
"morphine"
],
"offsets": [
[
247,
255
]
],
"normalized": []
},
{
"id": "72766",
"type": "Outcome_Physical",
"text": [
"( 1 ) no need for any additional analgesic therapy and ( 2 ) time to the first rescue analgesic therapy during the first 24 hours after the surgery ."
],
"offsets": [
[
1148,
1297
]
],
"normalized": []
},
{
"id": "72767",
"type": "Outcome_Physical",
"text": [
"additional ketoprofen therapy"
],
"offsets": [
[
1409,
1438
]
],
"normalized": []
},
{
"id": "72768",
"type": "Outcome_Physical",
"text": [
"additional analgesic intervention"
],
"offsets": [
[
1597,
1630
]
],
"normalized": []
},
{
"id": "72769",
"type": "Outcome_Pain",
"text": [
"pain severity"
],
"offsets": [
[
1779,
1792
]
],
"normalized": []
},
{
"id": "72770",
"type": "Outcome_Adverse-effects",
"text": [
"adverse effects"
],
"offsets": [
[
1821,
1836
]
],
"normalized": []
},
{
"id": "72771",
"type": "Participant_Condition",
"text": [
"Patients Undergoing Surgical Removal of an Odontogenic Maxillary Cyst"
],
"offsets": [
[
70,
139
]
],
"normalized": []
},
{
"id": "72772",
"type": "Participant_Condition",
"text": [
"the first 24 hours after odontogenic maxillary cyst removal under general anesthesia"
],
"offsets": [
[
376,
460
]
],
"normalized": []
},
{
"id": "72773",
"type": "Participant_Condition",
"text": [
"patients scheduled for surgical removal of an odontogenic maxillary cyst under general anesthesia"
],
"offsets": [
[
565,
662
]
],
"normalized": []
},
{
"id": "72774",
"type": "Participant_Sample-size",
"text": [
"48 eligible patients"
],
"offsets": [
[
1309,
1329
]
],
"normalized": []
}
] | [] | [] | [] |
72775 | 2648816 | [
{
"id": "72776",
"type": "document",
"text": [
"Adequacy of \" hot biopsy \" for the treatment of diminutive polyps : a prospective randomized trial . Patients with diminutive polyps in the rectum or sigmoid colon were randomized to \" hot biopsy \" treatment for either 1 ) electrocautery for 2 s ( fixed duration cautery ) or 2 ) cautery until visible necrosis of the polyp base was evident ( variable duration cautery ) . Sigmoidoscopy was performed 4 wk after treatment to determine the adequacy of polyp eradication . In the fixed duration cautery group , 11 of 21 polyps ( 52 % ) were eradicated , compared with 12 of 14 polyps ( 86 % ) in the variable duration cautery group ( p = 0.04 ) . When analyzed according to whether or not visible necrosis was achieved ( some of the polyps in the fixed duration cautery group showed necrosis with 2 s cautery ) , 19 of 23 polyps ( 83 % ) were eradicated when necrosis was evident , compared to 5 of 12 ( 42 % ) without necrosis ( p = 0.004 ) . We conclude that hot biopsy treatment for diminutive polyps is significantly more effective when visible necrosis is achieved during cautery . Furthermore , even with visible necrosis , there is a 17 % failure rate of polyp eradication ."
],
"offsets": [
[
0,
1179
]
]
}
] | [
{
"id": "72777",
"type": "Intervention_Surgical",
"text": [
"electrocautery"
],
"offsets": [
[
223,
237
]
],
"normalized": []
},
{
"id": "72778",
"type": "Intervention_Surgical",
"text": [
"cautery until visible necrosis of the polyp base was evident"
],
"offsets": [
[
280,
340
]
],
"normalized": []
},
{
"id": "72779",
"type": "Intervention_Physical",
"text": [
"Sigmoidoscopy"
],
"offsets": [
[
373,
386
]
],
"normalized": []
},
{
"id": "72780",
"type": "Outcome_Physical",
"text": [
"eradicated"
],
"offsets": [
[
539,
549
]
],
"normalized": []
},
{
"id": "72781",
"type": "Outcome_Physical",
"text": [
"visible necrosis"
],
"offsets": [
[
294,
310
]
],
"normalized": []
},
{
"id": "72782",
"type": "Outcome_Physical",
"text": [
"eradicated"
],
"offsets": [
[
539,
549
]
],
"normalized": []
},
{
"id": "72783",
"type": "Participant_Condition",
"text": [
"Patients with diminutive polyps in the rectum or sigmoid colon"
],
"offsets": [
[
101,
163
]
],
"normalized": []
}
] | [] | [] | [] |
72784 | 26499867 | [
{
"id": "72785",
"type": "document",
"text": [
"Do cognitive measures and brain circuitry predict outcomes of exercise in Parkinson Disease : a randomized clinical trial . BACKGROUND There is emerging research detailing the relationship between balance/gait/falls and cognition . Imaging studies also suggest a link between structural and functional changes in the frontal lobe ( a region commonly associated with cognitive function ) and mobility . People with Parkinson 's disease have important changes in cognitive function that may impact rehabilitation efficacy . Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson 's disease and play a role in rehabilitation efficacy . The purpose of this study is to 1 ) determine if people with Parkinson 's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2 ) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation . METHODS/DESIGN This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory . The study participants will be people with Parkinson 's disease who meet inclusion criteria for the study . The intervention will be 6 weeks of group exercise ( case ) and 6 weeks of group education ( control ) . The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD . The education program is a 6-week program to teach people how to better live with a chronic disease . The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility , cognition and neural imaging . DISCUSSION The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential . TRIAL REGISTRATION This trial is registered at clinical trials.gov ( NCT02231073 ) ."
],
"offsets": [
[
0,
2057
]
]
}
] | [
{
"id": "72786",
"type": "Intervention_Physical",
"text": [
"cognitively challenging mobility exercise program"
],
"offsets": [
[
927,
976
]
],
"normalized": []
},
{
"id": "72787",
"type": "Intervention_Physical",
"text": [
"exercise rehabilitation"
],
"offsets": [
[
1063,
1086
]
],
"normalized": []
},
{
"id": "72788",
"type": "Intervention_Physical",
"text": [
"6 weeks of group exercise ( case ) and 6 weeks of group education ( control )"
],
"offsets": [
[
1360,
1437
]
],
"normalized": []
},
{
"id": "72789",
"type": "Intervention_Physical",
"text": [
"cognitively challenging program based on the Agility Boot Camp"
],
"offsets": [
[
1458,
1520
]
],
"normalized": []
},
{
"id": "72790",
"type": "Intervention_Educational",
"text": [
"The education program"
],
"offsets": [
[
1542,
1563
]
],
"normalized": []
},
{
"id": "72791",
"type": "Intervention_Educational",
"text": [
"teach people how to better live with a chronic disease"
],
"offsets": [
[
1587,
1641
]
],
"normalized": []
},
{
"id": "72792",
"type": "Outcome_Other",
"text": [
"MiniBESTest"
],
"offsets": [
[
1679,
1690
]
],
"normalized": []
},
{
"id": "72793",
"type": "Outcome_Mental",
"text": [
"mobility , cognition and neural imaging ."
],
"offsets": [
[
1734,
1775
]
],
"normalized": []
}
] | [] | [] | [] |
72794 | 26510263 | [
{
"id": "72795",
"type": "document",
"text": [
"Effects of propofol and isoflurane on haemodynamics and the inflammatory response in cardiopulmonary bypass surgery . Cardiopulmonary bypass ( CPB ) causes reperfusion injury that when most severe is clinically manifested as a systemic inflammatory response syndrome . The anaesthetic propofol may have anti-inflammatory properties that may reduce such a response . We hypothesised differing effects of propofol and isoflurane on inflammatory markers in patients having CBR Forty patients undergoing elective CPB were randomised to receive either propofol or isoflurane for maintenance of anaesthesia . CRP , IL-6 , IL-8 , HIF-1α ( ELISA ) , CD11 and CD18 expression ( flow cytometry ) , and haemoxygenase ( HO-1 ) promoter polymorphisms ( PCR/electrophoresis ) were measured before anaesthetic induction , 4 hours post-CPB , and 24 hours later . There were no differences in the 4 hours changes in CRP , IL-6 , IL-8 or CD18 between the two groups , but those in the propofol group had higher HIF-1α ( P = 0.016 ) and lower CD11 expression ( P = 0.026 ) . After 24 hours , compared to the isoflurane group , the propofol group had significantly lower levels of CRP ( P < 0.001 ) , IL-6 ( P < 0.001 ) and IL-8 ( P < 0.001 ) , with higher levels CD11 ( P = 0.009 ) and CD18 ( P = 0.002 ) expression . After 24 hours , patients on propofol had increased expression of shorter HO-1 GT ( n ) repeats than patients on isoflurane ( P = 0.001 ) . Use of propofol in CPB is associated with a less adverse inflammatory profile than is isofluorane , and an increased up-regulation of HO-1 . This supports the hypothesis that propofol has anti-inflammatory activity ."
],
"offsets": [
[
0,
1655
]
]
}
] | [
{
"id": "72796",
"type": "Intervention_Pharmacological",
"text": [
"propofol"
],
"offsets": [
[
11,
19
]
],
"normalized": []
},
{
"id": "72797",
"type": "Intervention_Pharmacological",
"text": [
"isoflurane"
],
"offsets": [
[
24,
34
]
],
"normalized": []
},
{
"id": "72798",
"type": "Outcome_Physical",
"text": [
"haemodynamics and the inflammatory response"
],
"offsets": [
[
38,
81
]
],
"normalized": []
},
{
"id": "72799",
"type": "Outcome_Physical",
"text": [
"inflammatory markers"
],
"offsets": [
[
430,
450
]
],
"normalized": []
},
{
"id": "72800",
"type": "Outcome_Physical",
"text": [
"CRP"
],
"offsets": [
[
603,
606
]
],
"normalized": []
},
{
"id": "72801",
"type": "Outcome_Physical",
"text": [
"IL-6 , IL-8"
],
"offsets": [
[
609,
620
]
],
"normalized": []
},
{
"id": "72802",
"type": "Outcome_Physical",
"text": [
"HIF-1α ( ELISA )"
],
"offsets": [
[
623,
639
]
],
"normalized": []
},
{
"id": "72803",
"type": "Outcome_Physical",
"text": [
"CD11"
],
"offsets": [
[
642,
646
]
],
"normalized": []
},
{
"id": "72804",
"type": "Outcome_Physical",
"text": [
"CD18"
],
"offsets": [
[
651,
655
]
],
"normalized": []
},
{
"id": "72805",
"type": "Outcome_Physical",
"text": [
"haemoxygenase ( HO-1"
],
"offsets": [
[
692,
712
]
],
"normalized": []
},
{
"id": "72806",
"type": "Outcome_Physical",
"text": [
"promoter polymorphisms ( PCR/electrophoresis )"
],
"offsets": [
[
715,
761
]
],
"normalized": []
},
{
"id": "72807",
"type": "Outcome_Physical",
"text": [
"CRP"
],
"offsets": [
[
603,
606
]
],
"normalized": []
},
{
"id": "72808",
"type": "Outcome_Physical",
"text": [
"IL-6"
],
"offsets": [
[
609,
613
]
],
"normalized": []
},
{
"id": "72809",
"type": "Outcome_Physical",
"text": [
"IL-8"
],
"offsets": [
[
616,
620
]
],
"normalized": []
},
{
"id": "72810",
"type": "Outcome_Physical",
"text": [
"CD18"
],
"offsets": [
[
651,
655
]
],
"normalized": []
},
{
"id": "72811",
"type": "Outcome_Physical",
"text": [
"higher HIF-1α"
],
"offsets": [
[
986,
999
]
],
"normalized": []
},
{
"id": "72812",
"type": "Outcome_Physical",
"text": [
"CD11 expression"
],
"offsets": [
[
1024,
1039
]
],
"normalized": []
},
{
"id": "72813",
"type": "Outcome_Physical",
"text": [
"CRP"
],
"offsets": [
[
603,
606
]
],
"normalized": []
},
{
"id": "72814",
"type": "Outcome_Physical",
"text": [
"IL-6"
],
"offsets": [
[
609,
613
]
],
"normalized": []
},
{
"id": "72815",
"type": "Outcome_Physical",
"text": [
"IL-8"
],
"offsets": [
[
616,
620
]
],
"normalized": []
},
{
"id": "72816",
"type": "Outcome_Physical",
"text": [
"levels CD11"
],
"offsets": [
[
1237,
1248
]
],
"normalized": []
},
{
"id": "72817",
"type": "Outcome_Physical",
"text": [
"CD18"
],
"offsets": [
[
651,
655
]
],
"normalized": []
},
{
"id": "72818",
"type": "Outcome_Physical",
"text": [
"HO-1 GT ( n"
],
"offsets": [
[
1373,
1384
]
],
"normalized": []
},
{
"id": "72819",
"type": "Outcome_Physical",
"text": [
"of HO-1"
],
"offsets": [
[
1570,
1577
]
],
"normalized": []
},
{
"id": "72820",
"type": "Participant_Condition",
"text": [
"Cardiopulmonary bypass ( CPB )"
],
"offsets": [
[
118,
148
]
],
"normalized": []
},
{
"id": "72821",
"type": "Participant_Sample-size",
"text": [
"Forty patients"
],
"offsets": [
[
474,
488
]
],
"normalized": []
}
] | [] | [] | [] |
72822 | 26510728 | [
{
"id": "72823",
"type": "document",
"text": [
"Chronic fatigue syndrome ( CFS ) or myalgic encephalomyelitis ( ME ) is different in children compared to in adults : a study of UK and Dutch clinical cohorts . OBJECTIVE To investigate differences between young children , adolescents and adults with chronic fatigue syndrome/myalgic encephalomyelitis ( CFS/ME ) . STUDY DESIGN Comparison of clinical cohorts from 8 paediatric and 27 adult CFS/ME services in the UK and a paediatric randomised controlled trial from the Netherlands . Outcome measures include : fatigue ( the UK-Chalder Fatigue Scale ) ; Disability ( the UK-SF-36 physical function subscale ; the Netherlands-CHQ-CF87 ) ; school attendance , pain , anxiety and depression ( the UK-Hospital Anxiety & Depression Scale , Spence Children 's Anxiety Scale ; the Netherlands-Spielberger State-Trait Anxiety Inventory for Children , Children 's Depression Inventory ) ; symptoms ; time-to-assessment ; and body mass index . We used multinomial regression to compare younger ( aged < 12 years ) and older ( aged 12-18 years ) children with adults , and logistic regression to compare UK and Dutch adolescents . RESULTS Younger children had a more equal gender balance compared to adolescents and adults . Adults had more disability and fatigue , and had been ill for longer . Younger children were less likely to have cognitive symptoms ( OR 0.18 ( 95 % CI 0.13 to 0.25 ) ) and more likely to present with a sore throat ( OR 1.42 ( 1.07 to 1.90 ) . Adolescents were more likely to have headaches ( 81.1 % , OR 1.56 ( 1.36 % to 1.80 % ) ) and less likely to have tender lymph nodes , palpitations , dizziness , general malaise and pain , compared to adults . Adolescents were more likely to have comorbid depression ( OR 1.51 ( 1.33 to 1.72 ) ) and less likely to have anxiety ( OR 0.46 ( 0.41 to 0.53 ) ) compared to adults . CONCLUSIONS Paediatricians need to recognise that children with CFS/ME present differently from adults . Whether these differences reflect an underlying aetiopathology requires further investigation . TRIAL REGISTRATION NUMBERS FITNET trial registration numbers are ISRCTN59878666 and NCT00893438 . This paper includes secondary ( post-results ) analysis of data from this trial , but are unrelated to trial outcomes ."
],
"offsets": [
[
0,
2253
]
]
}
] | [
{
"id": "72824",
"type": "Intervention_Other",
"text": [
"multinomial regression"
],
"offsets": [
[
942,
964
]
],
"normalized": []
},
{
"id": "72825",
"type": "Outcome_Physical",
"text": [
"disability"
],
"offsets": [
[
1230,
1240
]
],
"normalized": []
},
{
"id": "72826",
"type": "Outcome_Physical",
"text": [
"fatigue"
],
"offsets": [
[
8,
15
]
],
"normalized": []
},
{
"id": "72827",
"type": "Outcome_Mental",
"text": [
"cognitive symptoms"
],
"offsets": [
[
1327,
1345
]
],
"normalized": []
},
{
"id": "72828",
"type": "Outcome_Physical",
"text": [
"headaches"
],
"offsets": [
[
1495,
1504
]
],
"normalized": []
},
{
"id": "72829",
"type": "Outcome_Physical",
"text": [
"lymph nodes , palpitations , dizziness , general malaise"
],
"offsets": [
[
1578,
1634
]
],
"normalized": []
},
{
"id": "72830",
"type": "Outcome_Pain",
"text": [
"pain"
],
"offsets": [
[
658,
662
]
],
"normalized": []
},
{
"id": "72831",
"type": "Outcome_Mental",
"text": [
"comorbid depression"
],
"offsets": [
[
1704,
1723
]
],
"normalized": []
},
{
"id": "72832",
"type": "Outcome_Mental",
"text": [
"anxiety"
],
"offsets": [
[
665,
672
]
],
"normalized": []
},
{
"id": "72833",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
85,
93
]
],
"normalized": []
},
{
"id": "72834",
"type": "Participant_Age",
"text": [
"young children"
],
"offsets": [
[
206,
220
]
],
"normalized": []
},
{
"id": "72835",
"type": "Participant_Age",
"text": [
"adolescents"
],
"offsets": [
[
223,
234
]
],
"normalized": []
},
{
"id": "72836",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
109,
115
]
],
"normalized": []
},
{
"id": "72837",
"type": "Participant_Condition",
"text": [
"chronic fatigue syndrome/myalgic encephalomyelitis ( CFS/ME )"
],
"offsets": [
[
251,
312
]
],
"normalized": []
},
{
"id": "72838",
"type": "Participant_Age",
"text": [
"younger ( aged < 12 years )"
],
"offsets": [
[
976,
1003
]
],
"normalized": []
},
{
"id": "72839",
"type": "Participant_Age",
"text": [
"older ( aged 12-18 years ) children"
],
"offsets": [
[
1008,
1043
]
],
"normalized": []
},
{
"id": "72840",
"type": "Participant_Age",
"text": [
"adults"
],
"offsets": [
[
109,
115
]
],
"normalized": []
},
{
"id": "72841",
"type": "Participant_Age",
"text": [
"Younger children"
],
"offsets": [
[
1128,
1144
]
],
"normalized": []
},
{
"id": "72842",
"type": "Participant_Age",
"text": [
"adolescents and adults"
],
"offsets": [
[
223,
245
]
],
"normalized": []
},
{
"id": "72843",
"type": "Participant_Age",
"text": [
"Adults"
],
"offsets": [
[
1214,
1220
]
],
"normalized": []
},
{
"id": "72844",
"type": "Participant_Age",
"text": [
"children"
],
"offsets": [
[
85,
93
]
],
"normalized": []
}
] | [] | [] | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.