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a b/clusters/3009knumclusters/clust_244.txt
1
Able to give written informed consent and comply with all study visits and procedures.
2
Patients and physicians must be willing to comply with treatment assignment:
3
The subject is willing and able to abide by the protocol
4
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
5
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
6
Patients must be deemed able to comply with the treatment plan and follow-up schedule
7
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
8
Participant is willing to comply with the protocol for the duration of the study, and undergo treatment and scheduled visits and examinations including follow up
9
Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
10
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
11
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
12
Subject has the willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
13
Willing to comply with clinical trial instructions and requirements, including mandatory biopsies
14
Ability to comply with the study protocol, in the investigator's judgment
15
Patients must be deemed able to comply with the treatment plan and follow-up schedule
16
Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
17
COHORT 1: As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
18
COHORT 2: As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
19
Ability to understand and the willingness to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by MRI (or CT), as confirmed by signing a written informed consent document
20
Ability to comply with study procedures in the Investigator's opinion
21
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
22
Must be able to comply with the treatment plan and follow-up schedule
23
Willing and able to comply with all aspects of the protocol
24
Subject should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.
25
Patients must be willing and able to complete all study procedures
26
Willingness and ability to comply with scheduled visits and study procedures
27
Patient able and willing to comply with study procedures as per protocol
28
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
29
Ability to understand and the willingness to sign a written informed consent document. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
30
Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
31
Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.
32
Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures.
33
Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
34
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, including follow-up
35
Be willing to comply with clinical trial instructions and requirements, including mandatory biopsies.
36
Patients >= 18 years must be willing to comply with the mandatory biopsies.
37
Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
38
Ability to understand and the willingness to sign a written informed consent document; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
39
Ability to comply with the study protocol, in the investigator's judgment
40
Willingness and ability to comply with study and follow-up procedures.
41
In the investigator’s judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
42
Participant must be willing and able to comply with all aspects of the protocol
43
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
44
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
45
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
46
Ability to understand and the willingness to sign a written informed consent document; patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
47
Willingness and ability to comply with scheduled visits (including geographical distance), treatment plans, laboratory tests, and other study procedures.
48
Willingness and ability to comply with study and follow-up procedures
49
Ability to comply with the study protocol, in the investigator's judgment
50
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
51
Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
52
Subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow assessments).
53
As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
54
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
55
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
56
Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests
57
Willing and able to comply with the scheduled visits
58
Limitation of the patient's ability to comply with the treatment or follow-up protocol.
59
Ability to comply with the protocol
60
Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
61
Ability to attend all scheduled study visits
62
Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
63
Willing and able to comply with scheduled visits, treatment plans, laboratory tests and procedures.
64
Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests
65
Willingness and ability to understand the nature of this study and to comply with the study and follow-up procedures.
66
Subject is able to comply with study procedures and follow-up examinations
67
Willing and able to comply with the protocol, including follow-up visits and examinations
68
Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study
69
Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
70
Must be willing and able to accept at least three leukapheresis procedures
71
Patient must be able and willing to comply with study procedures as per protocol
72
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations with follow up.
73
Subjects with a medical or psychological impediment that would impair the ability of the subject to receive therapy per protocol or impact ability to comply with the protocol or protocol-required visits and procedures
74
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan, procedures, and laboratory testing
75
Willingness and ability to comply with study procedures and follow-up examination
76
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by magnetic resonance imaging (MRI).
77
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
78
Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
79
Signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
80
Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures, and provide written informed consent
81
Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
82
Willingness and ability of the subject to comply with study activities.
83
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures (including all bone marrow biopsy/aspirations and radiographic studies), and study restrictions.
84
Be willing to comply with treatment protocol
85
Ability to comply with the treatment schedule
86
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement
87
Patient must be willing to comply with all aspects of the protocol including completing the drug diary
88
Ability to comply with the study protocol, in the investigator's judgment
89
In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
90
Willingness and ability to comply with the trial and follow-up procedures.
91
Willingness and ability to comply with scheduled visit, treatment plans, laboratory tests, and other procedures
92
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
93
Ability and willingness to comply with all study requirements, including scheduled visits, treatment plans, laboratory tests, and other study-related procedures
94
Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging
95
Subjects deemed unable to comply with study and/or follow-up procedures.
96
Ability to comply with the protocol
97
Stated willingness to comply with study procedures and duration.
98
Willing to travel to the NIH for follow-up visits
99
Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
100
Willing and able to comply with the protocol, including follow-up visits and examinations
101
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
102
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
103
As determined by the enrolling physician or protocol designee, willingness and ability of the subject to understand and comply with study procedures
104
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
105
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
106
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
107
Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
108
Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures
109
Participants must be willing to comply with all aspects of the protocol.
110
Must be willing and able to accept at least three leukapheresis procedures
111
In the investigators judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation
112
Ability to comply with the protocol
113
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
114
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
115
be willing and able to comply with study visits and procedures;
116
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
117
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
118
Patients willing to comply with the clinical trial protocol
119
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
120
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
121
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
122
Ability to comply with the protocol
123
Willing and able to give informed consent and comply with all aspects of the protocol
124
Stated willingness to comply with all study procedures and be available for the duration of the trial
125
Ability and capacity to comply with the study and follow-up procedures
126
Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
127
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
128
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
129
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
130
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
131
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study
132
Ability to comply with the protocol.
133
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
134
Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures
135
Must understand and be able, willing, and likely to fully comply with study procedures and restrictions.
136
Willingness and ability to comply with scheduled visits treatment plans, laboratory tests and other study procedures
137
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
138
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedure
139
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
140
Willing and able to complete study procedures within the study timelines
141
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study
142
Be willing to comply with treatment protocol
143
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.
144
Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
145
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
146
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
147
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
148
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
149
CELL PROCUREMENT: As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures
150
LYMPHODEPLETION: As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures
151
iC9-CAR19 CELL INFUSION: As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures
152
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
153
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.
154
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study
155
Subject likely to not be available to complete all protocol required study visits or procedures to the best of the subject and investigator's knowledge
156
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
157
Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
158
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
159
Patients must be willing to travel to the study site for follow-up visits
160
Presence of psychiatric or neurologic disease, or lack of social support that limits patient's ability to comply with the treatment protocol including supportive care, follow-up, and research tests
161
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
162
Willing and able to comply with required scheduled visits and study procedures.
163
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
164
Subject is willing and able to comply with all protocol required visits and assessments.
165
Patients must be willing and able to comply with scheduled visits, treatment and assessments
166
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
167
Must be willing and able to accept two leukapheresis procedures
168
PHASE I: Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
169
Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take axitinib, laboratory tests, and other study procedures
170
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
171
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures
172
Be able and willing to comply with study visits and procedures
173
Patients must express willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
174
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
175
Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
176
Able to give written informed consent and comply with all study visits and procedures
177
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
178
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
179
Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
180
Patient must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests
181
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
182
For the patient or parent/legal guardian to be able to comply with treatment plan, study procedures and follow-up examinations
183
Ability to understand and willingness for follow-up visits.
184
Willingness and ability to comply with all study procedures and able to take oral medications
185
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study
186
Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
187
The subject is willing and able to comply with the protocol, and agrees to return to the hospital for follow?up visits and examination
188
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
189
As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
190
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
191
Subject must be able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapy
192
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
193
Willing to comply with scheduled visits and procedures
194
Ability to comply with the treatment schedule
195
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
196
Willingness and ability to comply with study procedures and follow-up examinations
197
Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
198
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures
199
Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee
200
Comply with study procedures and site visits
201
Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
202
Be willing and able to comply with this protocol
203
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
204
Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the Investigator. Cohort 3B (Combination Expansion): Osteosarcoma subjects who progressed in Cohorts 1 or 2B and opt to receive combination therapy.
205
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
206
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
207
Willing and able to comply with all study procedures
208
Ability to comply with the protocol
209
Must be willing and able to comply with study
210
Willing and able to comply with the protocol, including follow-up visits and examinations
211
Patient is willing to comply with protocol requirements and procedures, and keep scheduled study visits
212
Subject is able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapy.
213
Patients must be capable of giving informed consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
214
Ability to comply with study and follow-up procedures
215
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures
216
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
217
Participant must be willing to comply with study and/or follow-up procedures
218
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
219
Patient is willing and able to comply with protocol required assessments and procedures
220
Be able to comply with study procedures and follow-up examinations
221
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
222
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
223
Must be willing and able to accept at least two leukapheresis procedures
224
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Subjects must participate fully and be willing to comply with the procedures of the protocol
225
Patients willing and able to comply with the study protocol for the duration of the study
226
Willing to comply with study procedures
227
Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests,\r\nother study procedures, and study restrictions
228
Able and willing to comply with testing and treatment as outlined in this protocol
229
Willingness to comply with study guidelines
230
Subject is willing and able to comply with all protocol required visits and assessments, including biopsy if assigned.
231
Willing and able to comply with clinic visits and study-related procedures
232
Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
233
Ability to understand and the willingness to sign a written informed consent document; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
234
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
235
Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)
236
Must be available during the duration of the study and willing to follow the study procedures
237
Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study. 2.Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study.
238
Patients who cannot comply with medications
239
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
240
Patients who are able and willing to give consent and able to attend all study visits
241
Patient able and willing to comply with study procedures as per protocol
242
Ability to comply with the protocol procedures (including geographic accessibility)
243
Patients must be able to comply with the protocol treatments and procedures.
244
Have the ability to understand and comply with the requirements and follow-up time points of the study
245
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
246
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
247
Subjects who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and procedures.
248
223 Subjects likely to not be available to complete all protocol- required study visits or procedures including BM aspirates/biopsies, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
249
Willingness and ability to comply with study and follow-up procedures
250
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
251
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
252
Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions; psychological, social, familial or geographical factors that might preclude adequate study participation should be considered
253
Subject is willing and able to comply with the protocol for the duration of the study
254
Willingness and ability to comply with study and follow-up procedures.
255
Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures, including ability to swallow study drug tablets and long-term follow-up
256
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and exams including follow up
257
Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
258
Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
259
Are able and willing to comply with all study procedures.
260
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
261
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
262
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
263
Subject must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
264
Able to comply with the protocol, including tissue and blood sampling
265
Have the willingness and ability to understand the nature of this study and to comply with the study and follow-up procedures.
266
The subject must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
267
State willingness to comply with all study procedures and be available for the duration of the trial
268
Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study
269
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
270
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
271
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
272
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
273
Patient must be able and willing to comply with study procedures as per protocol
274
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
275
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
276
Willingness and ability to comply with scheduled visits, drug administration plan,\n             laboratory tests, other study procedures, and study restrictions
277
Willingness and ability to comply with scheduled visits, treatment plans, laboratory\n             tests, and other study procedures
278
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
279
Emotional limitations, which the investigator judges could limit the patient's ability to follow up and comply with study procedures
280
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
281
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
282
Patients who, for medical or other reasons, are unable to comply with the study procedures
283
Able and willing to comply with study criteria
284
Willing and able to comply with all study procedures
285
Willing and able to comply with study procedures
286
Willing and able to comply with scheduled visits, treatment plan and laboratory tests, including biopsies
287
Willing and able to comply with follow-up schedule
288
Willingness and ability to consent for self and to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
289
Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.
290
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
291
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
292
Have the willingness and ability to comply with scheduled visit and study procedures.
293
Ability and willingness to comply with scheduled visits, treatment plan, laboratory assessments and other study procedures
294
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
295
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
296
Patients must comply with the treatment plan and follow-up schedule.
297
Ability to comply with the study protocol, in the investigator’s judgment
298
Limitation of the patient's ability to comply with the treatment or follow-up requirements.
299
Subject is willing and able to comply with all protocol required visits and assessments, including biopsy if assigned to the MTD expansion cohort;
300
Participant must be willing and able to comply with all aspects of the protocol.
301
Willing to comply with study procedures
302
Be willing and able to comply with all aspects of the protocol
303
Subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
304
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
305
Must be willing and able to accept two leukapheresis procedures
306
Is willing to and able to comply with scheduled visits and study procedures.
307
Willing and able to comply with all aspects of the protocol
308
Patient is willing and able to give consent and attend all study visits as defined in the protocol
309
Must be willing and able to accept at least two leukapheresis procedures
310
Willing and able to comply with all aspects of the treatment protocol
311
Subjects with a medical or psychological impediment that would impair the ability of the subject to receive therapy per protocol or impact ability to comply with the protocol or protocol-required visits and procedures
312
Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests
313
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
314
As determined by the enrolling physician or protocol designee, the subject should be able to understand and comply with study procedures for the entire length of the study
315
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
316
Signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
317
Ability to comply with study procedures
318
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
319
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
320
Must be willing and able to comply with study visits and procedures.
321
Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures
322
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study
323
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
324
Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
325
Available for the duration of the study and are willing to follow study-specific procedures.
326
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
327
Willingness to comply with all study interventions and follow-up procedures
328
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
329
Patients must provide signed, written, informed consent and be willing and able to comply with eligibility requirements, scheduled, visits, and follow-up studies
330
Subjects must give informed consent and must be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other procedures
331
Patients must be willing to travel to the study site for follow-up visits
332
The patient is able and willing to comply with all study related procedures
333
Willingness and ability to comply with study and follow-up procedures.
334
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
335
Have the willingness and ability to comply with scheduled visits and study procedures.
336
Subjects deemed unable to comply with study and/or follow-up procedures
337
Patient must be willing to comply with study procedures
338
Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests
339
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
340
As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
341
Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
342
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.
343
Ability and willingness to follow the guidelines of the clinical protocol including visits to National Institute of Child Health and Human Development (NICHD) and NCI, Bethesda, Maryland for treatment and follow up visits
344
Willing and able to comply with clinic visits and study-related procedures
345
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
346
Is able and willing to follow all study procedures
347
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
348
Patients must be willing and able to comply with study and/or follow-up procedures
349
Willing and able to comply with all aspects of the protocol
350
Willing to travel to the NIH for follow-up visits
351
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
352
Willing and able to comply with the protocol, including follow-up visits and examinations.
353
Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
354
Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol
355
Be able to comply with treatment plan, study procedures and follow-up examinations
356
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
357
able to comply with all study-related procedures, medication use, and evaluations.
358
Patient is able to comply with all study procedures including study drug administration, visits and tests
359
Able to comply with scheduled follow-up and with management of toxicity
360
Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
361
Able to comply with scheduled follow-up and with management of toxicity.
362
Subject agrees to comply with follow up visits
363
Patients must be willing to comply with effective Antiretroviral Therapy.
364
Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol
365
Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
366
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
367
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
368
Ability to comply with study procedures, in the Investigator's opinion
369
Subject must be willing and able to comply with all aspects of the protocol
370
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
371
Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.
372
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
373
Patients who are not able to comply with study and/or follow up procedures
374
Ability to understand and the willingness to sign a written informed consent and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
375
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
376
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
377
Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures
378
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
379
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
380
Stated willingness of patient to comply with study procedures and reporting requirements.
381
Be willing to comply with the protocol.
382
Willingness to comply with scheduled visits, drug administration plan, protocol-specified bone marrow biopsies;
383
Willing to comply with study procedures and follow-up
384
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
385
As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
386
Participant must be willing to comply with study and/or follow-up procedures
387
Patients must be willing to comply with study procedures
388
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
389
Be able to comply with study procedures and follow-up examinations
390
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
391
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
392
Willingness and ability to comply with study and followup procedures.
393
Willingness and ability to comply with study and follow-up procedures
394
Patients (or guardians/parents) who are able and willing to give consent (and assent where applicable) and able to attend all study visits
395
Ability to understand and the willingness to sign a written informed consent document and follow the guidelines of the clinical protocol including visits to National Cancer Institute (NCI), Bethesda, Maryland for treatment and follow up visits
396
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
397
Anticipated non-availability for study visits/procedures
398
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations
399
Be willing and able to comply with the protocol
400
Willing and able to comply with all aspects of the treatment protocol.
401
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
402
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
403
Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator's judgment
404
Patient must be willing and able to comply with the study procedures and visit schedules and must be able to follow verbal and written instructions.
405
Willing and able to comply with scheduled visits, study assessments and laboratory tests, and other study procedures
406
Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
407
Willing to give consent and comply with study-related evaluation and treatment schedule; and
408
Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment
409
Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions
410
Ability to comply with the protocol
411
Subject must be willing to comply with all procedures and assessments.
412
Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)
413
Able and willing to comply with all study procedures.
414
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
415
Patient must be willing and able to comply with the protocol for the duration of the study, including attending scheduled visits, examinations, the biopsy procedure, and having their tumor and blood molecularly characterized
416
Subject should be able to provide written informed consent and comply with protocol visits and procedures.
417
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
418
Is the subject willing and able to abide by the protocol?
419
Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
420
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
421
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including thrombokinetic studies and platelet function studies
422
Anticipated non-availability for study visits/procedures.
423
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
424
Reliable and available for the duration of the study and willing to follow study procedures.
425
Ability and willingness to follow the guidelines of the clinical protocol including visits to NCI, Bethesda, Maryland for treatment and follow up visits
426
Willing to comply with study procedures and follow-up
427
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
428
Willing and able to comply with the protocol guidelines for the duration of the study
429
Willingness and ability to comply with all study procedures
430
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures
431
Patient is willing and able to take oral medications and to comply with scheduled visits, treatment plan, and study related procedures
432
Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits.
433
Willing and able to comply with the protocol, including follow-up visits, examinations as well as having the ability to self-report pain and fatigue using a Patient-Reported Outcome (PRO) instrument
434
Patients who are able and willing to give consent and able to attend all study visits
435
201 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
436
Patients who are not able to comply with study and/or followup procedures
437
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
438
Willing and able to comply with scheduled visits, treatment plan and laboratory tests
439
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
440
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
441
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
442
Ability and capacity to comply with study and follow-up procedures
443
Subject agrees to comply with follow-up procedures, including returning for all follow-up visits
444
Ability to understand study procedures and to comply with them for the entire length of the study
445
Must be able to comply with follow up visits
446
Willing and able to comply with all aspects of study procedures
447
Be willing and able to adhere to all study-related procedures
448
Able and willing to comply with all study related procedures
449
Willing and able to undergo study assessment
450
Willing to comply with study procedures and reporting requirements
451
Not willing to comply with study procedures and reporting requirements
452
Subject is willing and able to comply with the follow-up regimen
453
Subject is willing and able to meet study requirements, including follow up visits
454
Willing to comply with all study procedures and be available for the duration of the study.
455
Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
456
Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
457
Willing to comply with study procedures and reporting requirements
458
Not willing to comply with study procedures and reporting requirements
459
Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
460
Patients must be willing to comply with the study procedures and visits
461
Subjects, who in the opinion of the investigator, may not be able to comply with study procedures
462
Have visits planned with the oncology physician for at least 3 months and be willing to come in for study visits
463
Be able to understand study procedures and comply with them for the entire length of the study period
464
Ability to understand and comply with study procedures for the entire length of the study
465
Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
466
Ability to comply with study procedures for the entire length of the study
467
Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory tests and other study procedures
468
The subject is able to complete the study and comply with study instructions, including attending all study visits
469
Is willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
470
Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
471
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study
472
Subject is willing and able to comply with all protocol required visits and assessments;
473
Patients must be deemed able to comply with the treatment plan and follow-up schedule
474
Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician
475
Any patients who are unable to comply with the study procedures as determined by the study investigators
476
Ability to understand and comply with study guidelines
477
Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).
478
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
479
The subject is willing and able to comply with the study protocol
480
Ability to understand study procedures and to comply with them for the entire length of the study
481
The subject is willing to comply with 30-day follow-up in the office and answer quality-of-life questionnaires per protocol
482
The subject is willing to comply with 90-day follow-up by phone
483
The subject is not willing to comply with 60-day follow-up in the office and answer quality-of-life questionnaires per protocol
484
The subject is not willing to comply with 90-day follow-up by phone
485
Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits
486
Willingness to comply with all study interventions of acupuncture and follow-up assessments
487
Participant is willing to be randomized and able to comply with the protocol
488
Willingness and ability to sign an IRB/IEC approved ICF before performance of any study specific procedures or tests and to comply with protocol visits, and study procedures.
489
Willing and able to comply with trial protocol and follow-up
490
Willingness to comply with study guidelines
491
Willing and able to comply with trial protocol and follow-up
492
Willingness to comply with all study interventions and follow-up procedures
493
Willing and able to comply with trial protocol and follow-up
494
RECIPIENT: Participant must be willing to comply with study and/or follow?up procedures, including willingness to be followed for one year post?HCT
495
Willingness to comply with all study interventions and follow-up procedures including the ability to apply the study drug to the breast
496
Willing to complete all study visits
497
Willing and able to comply with trial protocol and follow-up
498
Willingness to comply with all treatment and follow up procedures
499
Subjects, who, in the opinion of the clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-up visits
500
Subjects who are willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
501
Participant is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
502
Patient is willing and able to give consent attend all study visits and complete all questionnaires as defined in the protocol
503
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
504
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
505
Willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug
506
Willingness to comply with study guidelines
507
Willing to complete all study visits
508
Patients who are not able to comply with study and/or follow-up procedures
509
Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study
510
Be willing and able to comply with scheduled visits, treatment plan, and MR imaging
511
Be conscious and able to comply with study procedures
512
Subject must be willing to comply with all clinical study procedures
513
Willingness to comply with the study protocol
514
Willing to comply with all study procedures and be available for the duration of the study
515
Subjects must be willing and able to comply with all procedures and visits required for this protocol (pre-treatment, during treatment, and post-treatment)
516
PATIENT: Be able to comply with study procedures
517
Subject deemed unlikely to be able to comply with instructions during imaging
518
Patients must be willing and able to be compliant with all procedures and visits required for this protocol (pre-treatment, during treatment, and optionally throughout follow-up period)
519
Willing and able to comply with scheduled visits and serial imaging procedures
520
Ability and willingness to comply with the study procedures
521
Able to understand, follow written instruction and willing to participate in all visits without rescheduled more than one or missed a visit without cancellation or rescheduling (no show)
522
Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
523
Must be able to understand and comply with study procedures for the entire length of the study
524
Willing to comply with all study procedures and be available for the duration of the study.
525
Patient is not likely to comply with the follow-up evaluation schedule
526
Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.
527
Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol.
528
Ability and willingness to comply with all study requirements, including scheduled visits, treatment plans, laboratory tests, and other study-related procedures
529
Patients who are unable to comply with study and/or follow up procedures
530
The patient is willing and able to comply with the study protocol
531
Be capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits
532
Eligible subjects must be able and willing to undergo the procedures of the study
533
Be willing and able to comply with scheduled visits and other trial procedures
534
Willing and able to undergo all study procedures
535
Be willing and able to comply with scheduled visits and other trial procedures
536
Willing and able to comply with all aspects of the protocol.
537
Capable and willing to comply with the entire study protocol
538
Patients not able to comply with the study procedures
539
Able to comply with protocol visits and procedures
540
Are willing and able to comply with study procedures and instructions, including completion of diaries.
541
Willing and able to comply with all study procedures
542
Patient is not likely to comply with the follow-up evaluation schedule
543
Able and willing to follow study procedures and instructions.
544
Limitation of the patient's ability to comply with the treatment or follow-up protocol.
545
Able and willing to follow study procedures and instructions.
546
Available for all study visits and able to comply with all study requirements.
547
Subjects must be able and willing to follow study procedures and instructions.
548
Able and willing to complete the entire study
549
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
550
Subjects unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
551
Willingness and ability to comply with the trial and follow-up procedures.
552
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
553
Patient must be able to take oral medication and comply with protocol procedures and scheduled visits
554
Able and willing to complete the entire study
555
Participants must be willing and able to comply with all aspects of the protocol.
556
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; as determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study
557
Willingness and ability to comply with study procedures
558
As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study