[96a5a0]: / output / allTrials / logical / NCT00141765_logical.json

Download this file

879 lines (879 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
{
"info": {
"nct_id": "NCT00141765",
"official_title": "Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers",
"inclusion_criteria": "* Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:\n\n 1. is metastatic and has < 25% cure rate with conventional treatment; or\n 2. progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies.\n* Disease status: Within 3 weeks of initiation of this protocol, patients must:\n\n 1. be in a complete or good partial remission (section 7.4); or\n 2. have a \"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.\n* Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:\n\n 1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or\n 2. courses of high-dose ifosfamide totaling > 12 gm/m2.\n 3. 1 course of \"a)\" above, plus 1 course of 'b)\" above.\n 4. Equivalent high dose alkylating agents as described in 3.3 a, b, and c.\n* Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).\n* Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):\n\n 1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,\n 2. Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.\n* Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program\nHealthy volunteers allowed\nMust have maximum age of 21 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:",
"criterions": [
{
"exact_snippets": "ineligible for other IRB-approved myeloablative regimens",
"criterion": "eligibility for other IRB-approved myeloablative regimens",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
},
{
"exact_snippets": "21 years old or younger",
"criterion": "age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "years"
}
}
},
{
"exact_snippets": "histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor",
"criterion": "cancer type",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically-confirmed"
}
},
{
"exact_snippets": "histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Wilms' tumor",
"liver cancer",
"recurrent brain tumor of childhood",
"nasopharyngeal carcinoma",
"fibrosarcoma",
"desmoplastic small round cell tumor",
"germ cell tumor",
"other small round cell tumor"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "ineligible for other IRB-approved myeloablative regimens",
"criterion": "eligibility for other IRB-approved myeloablative regimens",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
},
{
"exact_snippets": "21 years old or younger",
"criterion": "age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "years"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor",
"criterion": "cancer type",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically-confirmed"
}
},
{
"exact_snippets": "histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Wilms' tumor",
"liver cancer",
"recurrent brain tumor of childhood",
"nasopharyngeal carcinoma",
"fibrosarcoma",
"desmoplastic small round cell tumor",
"germ cell tumor",
"other small round cell tumor"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "1. is metastatic and has < 25% cure rate with conventional treatment; or",
"criterions": [
{
"exact_snippets": "is metastatic",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "< 25% cure rate with conventional treatment",
"criterion": "cure rate with conventional treatment",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": "<",
"value": 25,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "is metastatic",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "< 25% cure rate with conventional treatment",
"criterion": "cure rate with conventional treatment",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": "<",
"value": 25,
"unit": "%"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies.",
"criterions": [
{
"exact_snippets": "progressed after prior chemotherapy",
"criterion": "progression after chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "< 25% salvage rate with non-myeloablative therapies",
"criterion": "salvage rate with non-myeloablative therapies",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": "<",
"value": 25,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "progressed after prior chemotherapy",
"criterion": "progression after chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "< 25% salvage rate with non-myeloablative therapies",
"criterion": "salvage rate with non-myeloablative therapies",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": "<",
"value": 25,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Disease status: Within 3 weeks of initiation of this protocol, patients must:",
"criterions": [
{
"exact_snippets": "Disease status: Within 3 weeks of initiation of this protocol",
"criterion": "disease status",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease status: Within 3 weeks of initiation of this protocol",
"criterion": "disease status",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "1. be in a complete or good partial remission (section 7.4); or",
"criterions": [
{
"exact_snippets": "be in a complete or good partial remission",
"criterion": "remission status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"complete remission",
"good partial remission"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "be in a complete or good partial remission",
"criterion": "remission status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"complete remission",
"good partial remission"
]
}
}
]
}
},
{
"identified_line": {
"line": "2. have a \"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.",
"criterions": [
{
"exact_snippets": "\"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy",
"criterion": "chemosensitive tumor",
"requirement": {
"requirement_type": "response to chemotherapy",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "\"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy",
"criterion": "chemosensitive tumor",
"requirement": {
"requirement_type": "progressive disease",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "\"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy",
"criterion": "chemosensitive tumor",
"requirement": {
"requirement_type": "response to chemotherapy",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "\"chemosensitive\" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy",
"criterion": "chemosensitive tumor",
"requirement": {
"requirement_type": "progressive disease",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or",
"criterions": [
{
"exact_snippets": "2 courses of high-dose cyclophosphamide",
"criterion": "cyclophosphamide treatment",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "totaling > 4200 mg/m2",
"criterion": "cumulative cyclophosphamide dose",
"requirement": {
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 4200,
"unit": "mg/m2"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "2 courses of high-dose cyclophosphamide",
"criterion": "cyclophosphamide treatment",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "totaling > 4200 mg/m2",
"criterion": "cumulative cyclophosphamide dose",
"requirement": {
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 4200,
"unit": "mg/m2"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. courses of high-dose ifosfamide totaling > 12 gm/m2.",
"criterions": [
{
"exact_snippets": "courses of high-dose ifosfamide totaling > 12 gm/m2",
"criterion": "ifosfamide dosage",
"requirement": {
"requirement_type": "total dosage",
"expected_value": {
"operator": ">",
"value": 12,
"unit": "gm/m2"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "courses of high-dose ifosfamide totaling > 12 gm/m2",
"criterion": "ifosfamide dosage",
"requirement": {
"requirement_type": "total dosage",
"expected_value": {
"operator": ">",
"value": 12,
"unit": "gm/m2"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. 1 course of \"a)\" above, plus 1 course of 'b)\" above.",
"criterions": [
{
"exact_snippets": "1 course of \"a)\" above",
"criterion": "treatment course a",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "1 course of 'b)\" above",
"criterion": "treatment course b",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "1 course of \"a)\" above",
"criterion": "treatment course a",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "1 course of 'b)\" above",
"criterion": "treatment course b",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Equivalent high dose alkylating agents as described in 3.3 a, b, and c.",
"criterions": [
{
"exact_snippets": "Equivalent high dose alkylating agents",
"criterion": "alkylating agents",
"requirement": {
"requirement_type": "dose",
"expected_value": "high"
}
},
{
"exact_snippets": "Equivalent high dose alkylating agents",
"criterion": "alkylating agents",
"requirement": {
"requirement_type": "equivalence",
"expected_value": "as described in 3.3 a, b, and c"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Equivalent high dose alkylating agents",
"criterion": "alkylating agents",
"requirement": {
"requirement_type": "dose",
"expected_value": "high"
}
},
{
"exact_snippets": "Equivalent high dose alkylating agents",
"criterion": "alkylating agents",
"requirement": {
"requirement_type": "equivalence",
"expected_value": "as described in 3.3 a, b, and c"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).",
"criterions": [
{
"exact_snippets": "adequate renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic ... function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... cardiac function",
"criterion": "cardiac function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "adequate renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic ... function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... cardiac function",
"criterion": "cardiac function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):",
"criterions": [
{
"exact_snippets": "Peripheral blood collection is to be preferred when available as an option",
"criterion": "peripheral blood collection",
"requirement": {
"requirement_type": "preference",
"expected_value": "preferred when available"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Peripheral blood collection is to be preferred when available as an option",
"criterion": "peripheral blood collection",
"requirement": {
"requirement_type": "preference",
"expected_value": "preferred when available"
}
}
]
}
},
{
"identified_line": {
"line": "2. Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.",
"criterions": [
{
"exact_snippets": "Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.",
"criterion": "CD34+ cells in peripheral blood",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x 10^6 cells/kg"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.",
"criterion": "CD34+ cells in peripheral blood",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x 10^6 cells/kg"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program",
"criterions": [
{
"exact_snippets": "Informed consent must be signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "indicating patient and/or parental awareness of the investigational nature of this program",
"criterion": "awareness of investigational nature",
"requirement": {
"requirement_type": "awareness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Informed consent must be signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "indicating patient and/or parental awareness of the investigational nature of this program",
"criterion": "awareness of investigational nature",
"requirement": {
"requirement_type": "awareness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 21 Years",
"criterions": [
{
"exact_snippets": "maximum age of 21 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 21 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:",
"criterions": [
{
"exact_snippets": "Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy.",
"criterion": "prior chemotherapy",
"requirement": {
"requirement_type": "benefit",
"expected_value": "maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy"
}
},
{
"exact_snippets": "Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue.",
"criterion": "conventional therapy",
"requirement": {
"requirement_type": "continuation",
"expected_value": [
"complete remission",
"no further benefit",
"toxicity perceived as limiting"
]
}
},
{
"exact_snippets": "The cancer must be proven to be sensitive to alkylating agents.",
"criterion": "cancer sensitivity to alkylating agents",
"requirement": {
"requirement_type": "sensitivity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy.",
"criterion": "prior chemotherapy",
"requirement": {
"requirement_type": "benefit",
"expected_value": "maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy"
}
},
{
"or_criteria": [
{
"exact_snippets": "Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue.",
"criterion": "conventional therapy",
"requirement": {
"requirement_type": "continuation",
"expected_value": "complete remission"
}
},
{
"exact_snippets": "Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue.",
"criterion": "conventional therapy",
"requirement": {
"requirement_type": "continuation",
"expected_value": "no further benefit"
}
},
{
"exact_snippets": "Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue.",
"criterion": "conventional therapy",
"requirement": {
"requirement_type": "continuation",
"expected_value": "toxicity perceived as limiting"
}
}
]
}
]
},
{
"exact_snippets": "The cancer must be proven to be sensitive to alkylating agents.",
"criterion": "cancer sensitivity to alkylating agents",
"requirement": {
"requirement_type": "sensitivity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,",
"criterions": [
{
"exact_snippets": "Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight",
"criterion": "nucleated cells in harvested bone marrow",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000000.0,
"unit": "nucleated cells per kg of body weight"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight",
"criterion": "nucleated cells in harvested bone marrow",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000000,
"unit": "nucleated cells per kg of body weight"
}
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}