[96a5a0]: / output / allTrials / identified / NCT01575782_identified.json

Download this file

1016 lines (1016 with data), 44.1 kB

   1
   2
   3
   4
   5
   6
   7
   8
   9
  10
  11
  12
  13
  14
  15
  16
  17
  18
  19
  20
  21
  22
  23
  24
  25
  26
  27
  28
  29
  30
  31
  32
  33
  34
  35
  36
  37
  38
  39
  40
  41
  42
  43
  44
  45
  46
  47
  48
  49
  50
  51
  52
  53
  54
  55
  56
  57
  58
  59
  60
  61
  62
  63
  64
  65
  66
  67
  68
  69
  70
  71
  72
  73
  74
  75
  76
  77
  78
  79
  80
  81
  82
  83
  84
  85
  86
  87
  88
  89
  90
  91
  92
  93
  94
  95
  96
  97
  98
  99
 100
 101
 102
 103
 104
 105
 106
 107
 108
 109
 110
 111
 112
 113
 114
 115
 116
 117
 118
 119
 120
 121
 122
 123
 124
 125
 126
 127
 128
 129
 130
 131
 132
 133
 134
 135
 136
 137
 138
 139
 140
 141
 142
 143
 144
 145
 146
 147
 148
 149
 150
 151
 152
 153
 154
 155
 156
 157
 158
 159
 160
 161
 162
 163
 164
 165
 166
 167
 168
 169
 170
 171
 172
 173
 174
 175
 176
 177
 178
 179
 180
 181
 182
 183
 184
 185
 186
 187
 188
 189
 190
 191
 192
 193
 194
 195
 196
 197
 198
 199
 200
 201
 202
 203
 204
 205
 206
 207
 208
 209
 210
 211
 212
 213
 214
 215
 216
 217
 218
 219
 220
 221
 222
 223
 224
 225
 226
 227
 228
 229
 230
 231
 232
 233
 234
 235
 236
 237
 238
 239
 240
 241
 242
 243
 244
 245
 246
 247
 248
 249
 250
 251
 252
 253
 254
 255
 256
 257
 258
 259
 260
 261
 262
 263
 264
 265
 266
 267
 268
 269
 270
 271
 272
 273
 274
 275
 276
 277
 278
 279
 280
 281
 282
 283
 284
 285
 286
 287
 288
 289
 290
 291
 292
 293
 294
 295
 296
 297
 298
 299
 300
 301
 302
 303
 304
 305
 306
 307
 308
 309
 310
 311
 312
 313
 314
 315
 316
 317
 318
 319
 320
 321
 322
 323
 324
 325
 326
 327
 328
 329
 330
 331
 332
 333
 334
 335
 336
 337
 338
 339
 340
 341
 342
 343
 344
 345
 346
 347
 348
 349
 350
 351
 352
 353
 354
 355
 356
 357
 358
 359
 360
 361
 362
 363
 364
 365
 366
 367
 368
 369
 370
 371
 372
 373
 374
 375
 376
 377
 378
 379
 380
 381
 382
 383
 384
 385
 386
 387
 388
 389
 390
 391
 392
 393
 394
 395
 396
 397
 398
 399
 400
 401
 402
 403
 404
 405
 406
 407
 408
 409
 410
 411
 412
 413
 414
 415
 416
 417
 418
 419
 420
 421
 422
 423
 424
 425
 426
 427
 428
 429
 430
 431
 432
 433
 434
 435
 436
 437
 438
 439
 440
 441
 442
 443
 444
 445
 446
 447
 448
 449
 450
 451
 452
 453
 454
 455
 456
 457
 458
 459
 460
 461
 462
 463
 464
 465
 466
 467
 468
 469
 470
 471
 472
 473
 474
 475
 476
 477
 478
 479
 480
 481
 482
 483
 484
 485
 486
 487
 488
 489
 490
 491
 492
 493
 494
 495
 496
 497
 498
 499
 500
 501
 502
 503
 504
 505
 506
 507
 508
 509
 510
 511
 512
 513
 514
 515
 516
 517
 518
 519
 520
 521
 522
 523
 524
 525
 526
 527
 528
 529
 530
 531
 532
 533
 534
 535
 536
 537
 538
 539
 540
 541
 542
 543
 544
 545
 546
 547
 548
 549
 550
 551
 552
 553
 554
 555
 556
 557
 558
 559
 560
 561
 562
 563
 564
 565
 566
 567
 568
 569
 570
 571
 572
 573
 574
 575
 576
 577
 578
 579
 580
 581
 582
 583
 584
 585
 586
 587
 588
 589
 590
 591
 592
 593
 594
 595
 596
 597
 598
 599
 600
 601
 602
 603
 604
 605
 606
 607
 608
 609
 610
 611
 612
 613
 614
 615
 616
 617
 618
 619
 620
 621
 622
 623
 624
 625
 626
 627
 628
 629
 630
 631
 632
 633
 634
 635
 636
 637
 638
 639
 640
 641
 642
 643
 644
 645
 646
 647
 648
 649
 650
 651
 652
 653
 654
 655
 656
 657
 658
 659
 660
 661
 662
 663
 664
 665
 666
 667
 668
 669
 670
 671
 672
 673
 674
 675
 676
 677
 678
 679
 680
 681
 682
 683
 684
 685
 686
 687
 688
 689
 690
 691
 692
 693
 694
 695
 696
 697
 698
 699
 700
 701
 702
 703
 704
 705
 706
 707
 708
 709
 710
 711
 712
 713
 714
 715
 716
 717
 718
 719
 720
 721
 722
 723
 724
 725
 726
 727
 728
 729
 730
 731
 732
 733
 734
 735
 736
 737
 738
 739
 740
 741
 742
 743
 744
 745
 746
 747
 748
 749
 750
 751
 752
 753
 754
 755
 756
 757
 758
 759
 760
 761
 762
 763
 764
 765
 766
 767
 768
 769
 770
 771
 772
 773
 774
 775
 776
 777
 778
 779
 780
 781
 782
 783
 784
 785
 786
 787
 788
 789
 790
 791
 792
 793
 794
 795
 796
 797
 798
 799
 800
 801
 802
 803
 804
 805
 806
 807
 808
 809
 810
 811
 812
 813
 814
 815
 816
 817
 818
 819
 820
 821
 822
 823
 824
 825
 826
 827
 828
 829
 830
 831
 832
 833
 834
 835
 836
 837
 838
 839
 840
 841
 842
 843
 844
 845
 846
 847
 848
 849
 850
 851
 852
 853
 854
 855
 856
 857
 858
 859
 860
 861
 862
 863
 864
 865
 866
 867
 868
 869
 870
 871
 872
 873
 874
 875
 876
 877
 878
 879
 880
 881
 882
 883
 884
 885
 886
 887
 888
 889
 890
 891
 892
 893
 894
 895
 896
 897
 898
 899
 900
 901
 902
 903
 904
 905
 906
 907
 908
 909
 910
 911
 912
 913
 914
 915
 916
 917
 918
 919
 920
 921
 922
 923
 924
 925
 926
 927
 928
 929
 930
 931
 932
 933
 934
 935
 936
 937
 938
 939
 940
 941
 942
 943
 944
 945
 946
 947
 948
 949
 950
 951
 952
 953
 954
 955
 956
 957
 958
 959
 960
 961
 962
 963
 964
 965
 966
 967
 968
 969
 970
 971
 972
 973
 974
 975
 976
 977
 978
 979
 980
 981
 982
 983
 984
 985
 986
 987
 988
 989
 990
 991
 992
 993
 994
 995
 996
 997
 998
 999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
{
"info": {
"nct_id": "NCT01575782",
"official_title": "Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.",
"inclusion_criteria": "* Histologically or cytologically confirmed stage I-III small cell lung cancer, excluding malignant pleural/pericardial effusion.\n* At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan\n* WHO performance status 0-2\n* Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.\n* Adequate renal function: calculated creatinine clearance at least 60 ml/min\n* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)\n* No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.\n* Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value\n* No history of prior chest radiotherapy\n* Life expectancy more than 6 months\n* Willing and able to comply with the study prescriptions\n* 18 years or older\n* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study\n* Ability to give and having given written informed consent before patient registration\n* No mixed pathology, e.g. non-small cell plus small cell cancer\n* No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction)\n* No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 3.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.\n* No cardiac conduction disturbances or medication potentially causing them:\n* QTc interval prolongation with other medications that required discontinuation of the treatment\n* Congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age\n* QT interval > 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible)\n* Patients on medication potentially prolongating the QT-interval are excluded if the QT-interval is > 460 msec (Appendix, table 2).\n* Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed (Appendix, Table 1). Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician (Appendix, table 2).\n* Complete left bundle branch block\n* No uncontrolled infectious disease\n* No other active malignancy\n* No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks\n* No treatment with investigational drugs in 4 weeks prior to or during this study\n* No chronic systemic immune therapy\n* No known G6PD deficiency\n* Patients must not have psoriasis or porphyria.\n* No known hypersensitivity to 4-aminoquinoline compound.\n* Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use.\n* No known prior hypersensitivity to cisplatin, etoposide or chloroquine or any of their components.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "- The opposite of the above",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically or cytologically confirmed stage I-III small cell lung cancer, excluding malignant pleural/pericardial effusion.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
},
{
"exact_snippets": "stage I-III small cell lung cancer",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
},
{
"exact_snippets": "small cell lung cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "small cell lung cancer"
}
]
},
{
"exact_snippets": "excluding malignant pleural/pericardial effusion",
"criterion": "malignant pleural/pericardial effusion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan",
"criterions": [
{
"exact_snippets": "At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan",
"criterion": "measurable disease site",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "site"
}
},
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* WHO performance status 0-2",
"criterions": [
{
"exact_snippets": "WHO performance status 0-2",
"criterion": "WHO performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count at least 1800/µl",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1800,
"unit": "µl"
}
}
]
},
{
"exact_snippets": "platelets at least 100000/µl",
"criterion": "platelets",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "µl"
}
}
]
},
{
"exact_snippets": "hemoglobin at least 6.2 mmol/l",
"criterion": "hemoglobin",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 6.2,
"unit": "mmol/l"
}
}
]
}
]
},
{
"line": "* Adequate renal function: calculated creatinine clearance at least 60 ml/min",
"criterions": [
{
"exact_snippets": "Adequate renal function: calculated creatinine clearance at least 60 ml/min",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "creatinine clearance",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
]
}
]
},
{
"line": "* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)",
"criterions": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution",
"criterion": "total bilirubin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
]
},
{
"exact_snippets": "ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution",
"criterion": "ALT, AST, and alkaline phosphatase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
]
},
{
"exact_snippets": "ALT, AST, and alkaline phosphatase ... (in case of liver metastases ≤ 5 x ULN for the institution)",
"criterion": "ALT, AST, and alkaline phosphatase in case of liver metastases",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "x ULN"
}
}
]
}
]
},
{
"line": "* No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.",
"criterions": [
{
"exact_snippets": "No previous platinum chemotherapy",
"criterion": "previous platinum chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No previous ... topo-isomerase-inhibitors for SCLC",
"criterion": "previous topo-isomerase-inhibitors for SCLC",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value",
"criterions": [
{
"exact_snippets": "Lung function: FEV1 at least 30 %",
"criterion": "FEV1",
"requirements": [
{
"requirement_type": "percentage of age predicted value",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "%"
}
}
]
},
{
"exact_snippets": "DLCO at least 30 % of the age predicted value",
"criterion": "DLCO",
"requirements": [
{
"requirement_type": "percentage of age predicted value",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "%"
}
}
]
}
]
},
{
"line": "* No history of prior chest radiotherapy",
"criterions": [
{
"exact_snippets": "No history of prior chest radiotherapy",
"criterion": "chest radiotherapy",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* Life expectancy more than 6 months",
"criterions": [
{
"exact_snippets": "Life expectancy more than 6 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Willing and able to comply with the study prescriptions",
"criterions": [
{
"exact_snippets": "Willing and able to comply with the study prescriptions",
"criterion": "compliance with study prescriptions",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* 18 years or older",
"criterions": [
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "willing to take adequate contraceptive measures",
"criterion": "contraceptive measures",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Ability to give and having given written informed consent before patient registration",
"criterions": [
{
"exact_snippets": "Ability to give and having given written informed consent",
"criterion": "written informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
},
{
"requirement_type": "status",
"expected_value": "given"
}
]
}
]
},
{
"line": "* No mixed pathology, e.g. non-small cell plus small cell cancer",
"criterions": [
{
"exact_snippets": "No mixed pathology, e.g. non-small cell plus small cell cancer",
"criterion": "mixed pathology",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction)",
"criterions": [
{
"exact_snippets": "recent (< 3 months) severe cardiac disease",
"criterion": "recent severe cardiac disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "NYHA class >1",
"criterion": "NYHA class",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "infarction",
"criterion": "infarction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 3.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.",
"criterions": [
{
"exact_snippets": "No history of cardiac arrythmia",
"criterion": "cardiac arrhythmia history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "multifocal premature ventricular contractions",
"criterion": "multifocal premature ventricular contractions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "uncontrolled atrial fibrillation",
"criterion": "uncontrolled atrial fibrillation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "bigeminy",
"criterion": "bigeminy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "trigeminy",
"criterion": "trigeminy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "ventricular tachycardia",
"criterion": "ventricular tachycardia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "symptomatic and requiring treatment (CTC AE 3.0)",
"criterion": "symptomatic cardiac arrhythmia requiring treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "asymptomatic sustained ventricular tachycardia",
"criterion": "asymptomatic sustained ventricular tachycardia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Asymptomatic atrial fibrillation controlled on medication is allowed",
"criterion": "asymptomatic atrial fibrillation controlled on medication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No cardiac conduction disturbances or medication potentially causing them:",
"criterions": [
{
"exact_snippets": "No cardiac conduction disturbances",
"criterion": "cardiac conduction disturbances",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No ... medication potentially causing them",
"criterion": "medication potentially causing cardiac conduction disturbances",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* QTc interval prolongation with other medications that required discontinuation of the treatment",
"criterions": [
{
"exact_snippets": "QTc interval prolongation",
"criterion": "QTc interval",
"requirements": [
{
"requirement_type": "prolongation",
"expected_value": true
}
]
},
{
"exact_snippets": "with other medications that required discontinuation of the treatment",
"criterion": "medication history",
"requirements": [
{
"requirement_type": "discontinuation due to QTc prolongation",
"expected_value": true
}
]
}
]
},
{
"line": "* Congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age",
"criterions": [
{
"exact_snippets": "Congenital long QT-syndrome",
"criterion": "congenital long QT-syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "unexplained sudden death of first degree relative under 40 years of age",
"criterion": "unexplained sudden death of first degree relative",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "years"
}
}
]
}
]
},
{
"line": "* QT interval > 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible)",
"criterions": [
{
"exact_snippets": "QT interval > 480 msec ... average QT-interval of these 3 measurements remains below 480 msec",
"criterion": "QT interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 480,
"unit": "msec"
}
},
{
"requirement_type": "average duration",
"expected_value": {
"operator": "<",
"value": 480,
"unit": "msec"
}
}
]
}
]
},
{
"line": "* Patients on medication potentially prolongating the QT-interval are excluded if the QT-interval is > 460 msec (Appendix, table 2).",
"criterions": [
{
"exact_snippets": "Patients on medication potentially prolongating the QT-interval",
"criterion": "medication",
"requirements": [
{
"requirement_type": "effect",
"expected_value": "potentially prolongating the QT-interval"
}
]
},
{
"exact_snippets": "QT-interval is > 460 msec",
"criterion": "QT-interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 460,
"unit": "msec"
}
}
]
}
]
},
{
"line": "* Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed (Appendix, Table 1). Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician (Appendix, table 2).",
"criterions": [
{
"exact_snippets": "Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed",
"criterion": "medication causing QT-prolongation or Torsades de pointes tachycardia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician",
"criterion": "drugs with a risk of prolongating the QT-interval",
"requirements": [
{
"requirement_type": "discontinuation",
"expected_value": false
},
{
"requirement_type": "monitoring",
"expected_value": "close monitoring by the treating physician"
}
]
}
]
},
{
"line": "* Complete left bundle branch block",
"criterions": [
{
"exact_snippets": "Complete left bundle branch block",
"criterion": "left bundle branch block",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": "complete"
}
]
}
]
},
{
"line": "* No uncontrolled infectious disease",
"criterions": [
{
"exact_snippets": "uncontrolled infectious disease",
"criterion": "infectious disease",
"requirements": [
{
"requirement_type": "control",
"expected_value": true
}
]
}
]
},
{
"line": "* No other active malignancy",
"criterions": [
{
"exact_snippets": "No other active malignancy",
"criterion": "active malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks",
"criterions": [
{
"exact_snippets": "No major surgery ... in previous 4 weeks",
"criterion": "major surgery",
"requirements": [
{
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* No treatment with investigational drugs in 4 weeks prior to or during this study",
"criterions": [
{
"exact_snippets": "No treatment with investigational drugs in 4 weeks prior to or during this study",
"criterion": "treatment with investigational drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
},
{
"requirement_type": "time frame",
"expected_value": "4 weeks prior to or during this study"
}
]
}
]
},
{
"line": "* No chronic systemic immune therapy",
"criterions": [
{
"exact_snippets": "No chronic systemic immune therapy",
"criterion": "chronic systemic immune therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No known G6PD deficiency",
"criterions": [
{
"exact_snippets": "No known G6PD deficiency",
"criterion": "G6PD deficiency",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients must not have psoriasis or porphyria.",
"criterions": [
{
"exact_snippets": "must not have psoriasis",
"criterion": "psoriasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "must not have ... porphyria",
"criterion": "porphyria",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No known hypersensitivity to 4-aminoquinoline compound.",
"criterions": [
{
"exact_snippets": "No known hypersensitivity to 4-aminoquinoline compound.",
"criterion": "hypersensitivity to 4-aminoquinoline compound",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use.",
"criterions": [
{
"exact_snippets": "retinal or visual field changes from prior 4-aminoquinoline compound use",
"criterion": "retinal or visual field changes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "- The opposite of the above",
"criterions": [
{
"exact_snippets": "The opposite of the above",
"criterion": "opposite condition",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "opposite of previous criteria"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* No known prior hypersensitivity to cisplatin, etoposide or chloroquine or any of their components.",
"criterions": [
{
"exact_snippets": "No known prior hypersensitivity to cisplatin",
"criterion": "hypersensitivity to cisplatin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No known prior hypersensitivity to etoposide",
"criterion": "hypersensitivity to etoposide",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No known prior hypersensitivity to chloroquine",
"criterion": "hypersensitivity to chloroquine",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No known prior hypersensitivity to ... any of their components",
"criterion": "hypersensitivity to components of cisplatin, etoposide, or chloroquine",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}