[96a5a0]: / output / allTrials / identified / NCT04677673_identified.json

Download this file

396 lines (396 with data), 15.9 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
{
"info": {
"nct_id": "NCT04677673",
"official_title": "Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients",
"inclusion_criteria": "* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.\n* Clinical stage: cTNM: stage III\n* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)\n* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 76 Years",
"exclusion_criteria": "* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia\n* Distant metastases (including retroperitoneal lymph node)\n* Locally advanced inoperable disease (Clinical assessment)\n* Relapse of gastric cancer\n* Malignant secondary disease\n* Prior chemo or radiotherapy\n* Inclusion in another clinical trial\n* Known contraindications or hypersensitivity for planned chemotherapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.",
"criterions": [
{
"exact_snippets": "Histology confirmed",
"criterion": "histology confirmation",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": "non-obstructive adenocarcinoma",
"criterion": "adenocarcinoma type",
"requirements": [
{
"requirement_type": "obstruction",
"expected_value": false
}
]
},
{
"exact_snippets": "adenocarcinoma of the stomach or esophagogastric junction",
"criterion": "adenocarcinoma location",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"stomach",
"esophagogastric junction"
]
}
]
}
]
},
{
"line": "* Clinical stage: cTNM: stage III",
"criterions": [
{
"exact_snippets": "Clinical stage: cTNM: stage III",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "III"
}
]
}
]
},
{
"line": "* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)",
"criterions": [
{
"exact_snippets": "Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "scale",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
}
]
}
]
},
{
"line": "* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.",
"criterions": [
{
"exact_snippets": "Clinically fit for systemic chemotherapy",
"criterion": "fitness for systemic chemotherapy",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": true
}
]
},
{
"exact_snippets": "Clinically fit for ... gastric cancer surgery",
"criterion": "fitness for gastric cancer surgery",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": true
}
]
},
{
"exact_snippets": "adequate renal ... function",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "adequate ... hepatic ... function",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "adequate ... hematologic ... function",
"criterion": "hematologic function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "adequate ... pulmonary function",
"criterion": "pulmonary function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"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 76 Years",
"criterions": [
{
"exact_snippets": "minimum age of 76 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 76,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia",
"criterions": [
{
"exact_snippets": "Clinically unfit for systemic chemotherapy",
"criterion": "fitness for systemic chemotherapy",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": false
}
]
},
{
"exact_snippets": "Clinically unfit for ... gastric cancer surgery",
"criterion": "fitness for gastric cancer surgery",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": false
}
]
},
{
"exact_snippets": "uncontrolled cardiac disease",
"criterion": "cardiac disease",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "other clinically significant uncontrolled comorbidities",
"criterion": "clinically significant comorbidities",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "unable to undergo general anesthesia",
"criterion": "ability to undergo general anesthesia",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Distant metastases (including retroperitoneal lymph node)",
"criterions": [
{
"exact_snippets": "Distant metastases",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "retroperitoneal lymph node",
"criterion": "retroperitoneal lymph node metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Locally advanced inoperable disease (Clinical assessment)",
"criterions": [
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease operability",
"requirements": [
{
"requirement_type": "operability",
"expected_value": "inoperable"
}
]
},
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "locally advanced"
}
]
}
]
},
{
"line": "* Relapse of gastric cancer",
"criterions": [
{
"exact_snippets": "Relapse of gastric cancer",
"criterion": "gastric cancer",
"requirements": [
{
"requirement_type": "relapse",
"expected_value": true
}
]
}
]
},
{
"line": "* Malignant secondary disease",
"criterions": [
{
"exact_snippets": "Malignant secondary disease",
"criterion": "malignant secondary disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior chemo or radiotherapy",
"criterions": [
{
"exact_snippets": "Prior chemo or radiotherapy",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"chemo",
"radiotherapy"
]
}
]
}
]
},
{
"line": "* Inclusion in another clinical trial",
"criterions": [
{
"exact_snippets": "Inclusion in another clinical trial",
"criterion": "inclusion in another clinical trial",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Known contraindications or hypersensitivity for planned chemotherapy",
"criterions": [
{
"exact_snippets": "Known contraindications ... for planned chemotherapy",
"criterion": "contraindications for planned chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "hypersensitivity for planned chemotherapy",
"criterion": "hypersensitivity for planned chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}