[96a5a0]: / output / allTrials / identified / NCT03372720_identified.json

Download this file

302 lines (302 with data), 12.8 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
{
"info": {
"nct_id": "NCT03372720",
"official_title": "Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies",
"inclusion_criteria": "* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment\n\n * Any form of hysterectomy, including radical hysterectomy permitted\n * Must have no evidence of recurrent disease on pelvic exam within past 3 months\n * Radiation therapy is permitted but not required\n* Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain\nHealthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer\n* Pelvic organ prolapse stage II or higher\n* Prior reconstructive pelvic surgery involving mesh\n* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment",
"criterions": [
{
"exact_snippets": "Women with cervical, endometrial, vaginal, vulvar or ovarian cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"cervical",
"endometrial",
"vaginal",
"vulvar",
"ovarian"
]
}
]
},
{
"exact_snippets": "have completed all cancer related treatment >= 6 months prior to enrollment",
"criterion": "completion of cancer treatment",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Any form of hysterectomy, including radical hysterectomy permitted",
"criterions": [
{
"exact_snippets": "Any form of hysterectomy, including radical hysterectomy permitted",
"criterion": "hysterectomy",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"any form",
"radical"
]
}
]
}
]
},
{
"line": "* Must have no evidence of recurrent disease on pelvic exam within past 3 months",
"criterions": [
{
"exact_snippets": "no evidence of recurrent disease on pelvic exam",
"criterion": "recurrent disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "within past 3 months",
"criterion": "pelvic exam",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within past 3 months"
}
]
}
]
},
{
"line": "* Radiation therapy is permitted but not required",
"criterions": [
{
"exact_snippets": "Radiation therapy is permitted but not required",
"criterion": "radiation therapy",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
},
{
"requirement_type": "permission",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain",
"criterions": [
{
"exact_snippets": "Patient reported dyspareunia ... severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
"criterion": "dyspareunia",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "scale from 0 to 10"
}
}
]
},
{
"exact_snippets": "Patient reported ... vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
"criterion": "vaginal dryness",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "scale from 0 to 10"
}
}
]
},
{
"exact_snippets": "dyspareunia and/or vaginal dryness ... persistent over >= 4 weeks",
"criterion": "dyspareunia and/or vaginal dryness",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "inability to be sexually active due to pain",
"criterion": "inability to be sexually active due to pain",
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
"criterions": [
{
"exact_snippets": "recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"endometrial",
"vaginal",
"vulvar",
"cervical",
"ovarian"
]
}
]
},
{
"exact_snippets": "recurrent or metastatic",
"criterion": "cancer status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"recurrent",
"metastatic"
]
}
]
}
]
},
{
"line": "* Pelvic organ prolapse stage II or higher",
"criterions": [
{
"exact_snippets": "Pelvic organ prolapse stage II or higher",
"criterion": "pelvic organ prolapse",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Prior reconstructive pelvic surgery involving mesh",
"criterions": [
{
"exact_snippets": "Prior reconstructive pelvic surgery involving mesh",
"criterion": "reconstructive pelvic surgery",
"requirements": [
{
"requirement_type": "involvement",
"expected_value": "mesh"
}
]
}
]
},
{
"line": "* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment",
"criterions": [
{
"exact_snippets": "Hormone replacement therapy ... within 6 weeks prior to enrollment",
"criterion": "hormone replacement therapy",
"requirements": [
{
"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "vaginal estrogen therapy within 6 weeks prior to enrollment",
"criterion": "vaginal estrogen therapy",
"requirements": [
{
"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}