[c09aa8]: / clusters / 3009knumclusters / clust_223.txt

Download this file

360 lines (359 with data), 43.5 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
Concurrent therapy with other Investigational Products.
Patient has history of allergy to any oily drug products
- INCLUSION CRITERIA:\n\n - Patients of any age or either gender with indications for receipt of investigational\n HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for\n unrelated hematopoietic stem cell transplantation.\n\n - Signed informed consent (and assent when applicable).\n\n EXCLUSION CRITERIA:\n\n - Patients who are receiving licensed CB products (only)\n\n - Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
Appropriate antibiotics, blood products, anti-emetics, fluids, electrolytes and general supportive care are to be used as necessary
Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax
Known prior severe hypersensitivity to the investigational products or any component in their formulations,
Treatment with any investigational products within 14 days before the first dose of protocol-indicated treatment
Known hypersensitivity or allergy to murine products or any component of the obinutuzumab, rituximab, idasanutlin, or venetoclax formulation
Patients with history of hypersensitivity to liposomal products
Treatment with any investigational products within 28 days prior to study registration
Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week prior to study registration (subjects already receiving erythropoietin on a chronic basis for >= 28 days are eligible)
Known sensitivity to any of the products or components to be administered during dosing.
The following women are WOCBP:\r\n* Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides)\r\n* Women who are practicing abstinence\r\n* Women who have a partner who is sterile (e.g., due to vasectomy)
Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib
Patients using over the counter supplements or other natural products within one week of treatment, excluding vitamins and calcium supplementation, or at the discretion of the enrolling physician, will be excluded
Known allergy to egg products or soy bean oil
History of hypersensitivity reactions to murine protein-containing products
Known sensitivity to any of the products or components to be administered during dosing.
Refusal to potentially receive blood products and/or have a hypersensitivity to blood products
Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
Consumption of grapefruits, grapefruit products, Seville oranges (including marmalade that contains Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax.
Known sensitivity or allergy to murine products or any component of RO6870810, venetoclax, or rituximab.
INCLUSION - TREATMENT: Available autologous activated peripheral blood T cell products with ? 20% expression of CD5.CAR.28 zeta and < 0.5% gene-modified malignant T blasts by flow cytometry
EXCLUSION - TREATMENT: History of hypersensitivity reactions to murine protein-containing products
History of severe hypersensitivity reactions to cisplatin or vinblastine or other products of the same class;
Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.
TREATMENT EXCLUSION: History of hypersensitivity reactions to murine protein-containing products
Have known allergy to ovalbumin or other egg products
Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study
Treatment with any investigational products within 30 days before randomization.
Treatment with any investigational products within 14 days before the first dose of study drug
Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (patients already receiving erythropoietin on a chronic basis for >= 4 weeks are eligible)
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) within 4 weeks of study drug administration (day 1)
History of hypersensitivity reactions to murine protein-containing products
EXCLUSION - TREATMENT: History of hypersensitivity reactions to murine protein-containing products
Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
AUTOLOGOUS APHERESIS: History of hypersensitivity reactions to murine protein-containing products
TREATMENT WITH SJCAR19: History of hypersensitivity reactions to murine protein-containing products
The use of any herbal products that may lower PSA levels (e.g. saw palmetto).
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Subject has consumed grapefruit, grapefruit products, seville oranges (including marmalade containing seville oranges) or star fruit within 3 days prior to the initiation of study treatment
Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC- HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 28 days of study treatment initiation or plans to initiate treatment with these products/alternative therapies during the entire duration of the study
Known allergy to PEGylated products
Treatment with any investigational products within 4 weeks before the first dose of study drug.
Current use of natural herbal products or other “folk remedies”; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed
Patients who are receiving licensed cord blood products (only)
Patients who are receiving unlicensed cord blood products from other banks (only)
Patients who are receiving cord blood products that will be \manipulated\ post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Known prior or suspected hypersensitivity to investigational products
Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
Patient has known sensitivity to any of the products to be administered during dosing
To be performed within 14 days prior to day 1 of protocol therapy: platelets >= 100,000/mm^3\r\n* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
Treatment with any investigational products within 14 days before the first dose of any study drug
Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Known allergy to eggs, egg products, aminoglycoside antibiotics (e.g. gentamicin or tobramycin)
Herbal products that may decrease PSA levels (e.g., saw palmetto) unless discontinued two weeks prior to randomization.
Received blood products within 30 days to first dosing
Patients must avoid consumption of grapefruit, pomegranates, starfruit, Seville oranges or products containing the juice of each during the entire study and preferably 7 days before the first dose of study medications; orange juice is allowed
Patients with known sensitivities to albumin, blood, or blood products
A known hypersensitivity to any of the test materials or related compounds including murine and bovine products;
Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods\r\n(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Consuming grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting venetoclax
Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study, as these may affect selumetinib metabolism
Known hypersensitivity to any component of the investigational products
Consumption of grapefruit, grapefruit hybrids, pummelos, star-fruit, Seville oranges or products containing the juice of each within 7 days prior to study registration.
Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.
Previous treatment with venetoclax and/or current participation in any other research study with investigational products.
No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
Hypersensitivity to any of the investigational agents under test, or any excipient of these products
Patients with a known hypersensitivity to any of the investigational agents or any of the excipients of the products
Concurrent therapy with other investigational products
History of smoking tobacco (or other related/herbal products) in the prior 3 months
Has a known hypersensitivity to any of the study therapy products
Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (participants already receiving erythropoietin on a chronic basis for >=4 weeks are eligible).
Treatment with any investigational products within 14 days before the first dose of any study drug
Intolerance to infused protein products, sucrose, histidine or polysorbate 80
Currently using aluminum-containing antacid products
Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D)
Confirmed availability of production capacities for the patient's ACTolog products.
Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), sargramostim (GM-CSF) or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study
Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.
Blood transfusion (including blood products) within 1 week of screening.
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids within 6 months of enrollment
Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting study drugs
Previous treatment with investigational gene or cell therapy medicine products
Treatment with any investigational products within 14 days before the first dose of study drug
Treatment with any investigational products within 3 weeks before the first dose of study drug
Patients with a known sensitivity to any of the products to be administered during treatment
Consumption of grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products within 7 days prior to first dose
Known hypersensitivity to 5-fluorouracil, capecitabine, bevacizumab or to any component of the investigational products or compounds of similar chemical composition
Consumption of grapefruit, grapefruit juice, grapefruit hybrids, pomelos, pomegranates, star fruits, Seville oranges or related products within 7 days prior to first dose
Patients who decline possible transfusion of blood products will be excluded
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin)
Consumption or use of any Noni or Noni-containing products
DONOR: Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test products
Patients must be willing to receive transfusions of blood products
Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (patients already receiving erythropoietin on a chronic basis for >= 4 weeks are eligible)
User of herbal products
Patients with known allergy to bovine or murine products
Treatment with any investigational products within 3 weeks before the first dose of study drug
No history of hypersensitivity reactions to murine protein-containing products
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a history of hypersensitivity to murine protein-containing products
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies
AT THE TIME OF INFUSION: History of hypersensitivity reactions to murine protein-containing products
Agreement not to donate blood or blood products during the study and for 7 months after discontinuation of vismodegib
Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used)
History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded)
Patient must not have had prior exposure to gene vector delivery products within 3 months.
Known hypersensitivity to any of the products used in the trial – G-CSF (Neupogen, filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or O6BG/BCNU in vivo selection regimens
Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
Known sensitivity to any of the products to be administered during dosing
Patients with a known history of allergy to soy products
History of hypersensitivity reactions to products containing irinotecan (irinotecan), topotecan or other topoisomerase inhibitors, gadolinium contrast agents or lipid products
Known hypersensitivity to any of the components of MM-398 or other liposomal products
No known hypersensitivity to murine products
Relapsed/refractory MCL: Patients must be willing to receive transfusions of blood products
Previous treatment with any substrate of CYP2B6 enzyme < 14 days prior to initiation of investigational products
Available autologous or syngeneic activated peripheral blood T cell products (CD28zeta and CD28/CD137zeta) with >= 15% expression of CD19.CAR determined by flow cytometry
History of hypersensitivity reactions to murine protein-containing products
Smokers and subjects who use smokeless tobacco products are excluded in all cohorts
History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation
History of hypersensitivity to bevacizumab, murine products, or any component of the formulation
History of hypersensitivity to cetuximab, murine products, or any component of the formulation
Use of herbal products that may decrease PSA levels (i.e., saw palmetto) (no washout period required)
Appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary
DONOR: Has not donated blood products to recipient
History of hypersensitivity reactions to murine protein-containing products
History of hypersensitivity reactions to murine protein-containing products
Treatment with any investigational products within 4 weeks before the first dose of any study drug
Donation of blood or blood products in excess of 500 mL within 84 days of screening
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors within 4 weeks prior to study Day 1.
Known sensitivity to E. coli derived products.
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
Had prior exposure to gene vector delivery products within 6 months
Patients taking any clay products
Concurrent use of tobacco products (other than cigarettes) or nicotine products.
217 Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
Known prior severe hypersensitivity to investigational products or any component in their formulations
Unwillingness to receive infusion of blood products.
Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used.
Patients with known allergy to bovine or murine products.
Herbal (e.g., saw palmetto) and non-herbal (e.g., pomegranate) products that may decrease PSA levels
Treatment with any investigational products within 28 days prior to study registration
Patients must be willing to receive transfusions of blood products.
Known sensitivity to any of the products to be administered during the study (e.g., calcium, or vitamin D)
No known hypersensitivity to Escherichia (E.) coli-derived products
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies
Known hypersensitivity to any of the products used in the trial-G-CSF (Neupogen), plerixafor, or any planned components of conditioning regimens
Treatment with other investigational products within the last 2 months prior to entry into this study
History of smoking either tobacco or other herbal products in the last 3 months
Serious hypersensitivity reaction to egg products
No history of hypersensitivity to murine protein containing products
History of hypersensitivity reactions to murine protein-containing products
Patients with a history of a hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
History of hypersensitivity reactions to murine protein-containing products
Unwillingness to receive infusion of blood products according to the protocol.
Have a history of hypersensitivity to human or mouse antibody products.
Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing.
Known hypersensitivity to any of the components of MM-398, other liposomal products, fluoropyrimidines or leucovorin
Patients who are known sensitive to any of the products or components to be administered during treatment with talimogene laherparepvec
Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
Treatment with any anti leukemic/anti MDS therapies (eg, lenalidomide, cytarabine, anthracyclines, purine analogs) or with any investigational products within 14 days before the first dose of any study drug.
Grapefruit, Seville oranges or products containing either juice
Current or past history of severe hypersensitivity to any other antibody products
Known hypersensitivity or allergy sunitinib or to chemically related products or likely to be exacerbated to by any component of the study products
Exposure to other investigational products within 28 days prior to Screening Visit
Hypersensitivity to cytarabine, daunorubicin or liposomal products
Known hypersensitivity to any of the excipients of the investigational products
Not be allergic to tomatoes or tomato products
Known sensitivity or allergy to murine products.
Known allergy to ovalbumin or other egg products
Subject is unwilling to allow transfusion of blood or blood products.
History of hypersensitivity reactions to murine protein-containing products
Has not donated blood products to patient
Patients with a known sensitivity to any of the products to be administered during treatment and assessments.
Participants must agree not to use natural herbal products or other “folk remedies” while participating in this study
Within 72 hour (h) of initiating study treatment: Hemoglobin (Hgb) >= 9.0 g/dL; Note: transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment
Within 72 h of initiating study treatment: Absolute neutrophil count (ANC) >= 1000/mm^3; Note: transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment
Within 72 h of initiating study treatment: Platelets >= 100,000/mm^3; Note: transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin)
Consent to potential need for transfusion of blood products
Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (patients already receiving erythropoietin on a chronic basis for >= 4 weeks are eligible)
Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study treatment
Patients must be willing to receive transfusions of blood products
Has a known hypersensitivity to any of the study therapy products
Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
Transfusion of blood products are not allowed to normalize blood parameters within 4 weeks of the first radium treatment
Treatment with any investigational products within 60 days before the first dose of the study drug regimen.
Use of herbal products that may decrease PSA levels (e.g., saw palmetto)
Known hypersensitivity to cytarabine, daunorubicin or liposomal products
Allergy to soy, egg, or peanut products
Consumed grapefruit or grapefruit products, seville oranges (including marmalade containing seville oranges), or star fruit within 3 days prior to the first dose of study treatment
Patients must not have known hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Steven-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other products component
Participants may not use natural herbal products or remedies not approved by the Food and Drug Administration (FDA) while participating in this study
Received radiation therapy =< 14 days prior to initiation of investigational products
Known hypersensitivity to 5-fluorouracil or to any component of the investigational products or compounds of similar chemical composition
Known prior or suspected hypersensitivity to investigational products.
Treatment with any investigational products within 4 weeks before the first dose of any study drug
Patients have known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D)
No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
Known hypersensitivity reaction to mushroom products
Treatment with any investigational products within 30 days before the first dose of study drug
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Treatment with any investigational products within 60 days before the first dose of the study drug regimen
Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX) if receiving soybean agglutinin and E-rosetting (SBA-E) bone marrow, or chicken egg products
Patients must be willing to receive transfusions of blood products
Hypersensitivity to cytarabine, daunorubicin or liposomal products
Patients who have used tobacco or nicotine products or medications within the last three months given their significant effect on erlotinib drug levels
Allergy to murine products or positive human anti-mouse antibody (HAMA)
Patients with a known hypersensitivity to any of the components of the drug products
Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment
No known hypersensitivity to murine products
Known sensitivity or allergy to murine products.
Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 1 week prior to the start of investigational product
All patients should agree not to donate blood products for 12 months after stopping sonidegib
Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
Patients with a known hypersensitivity to any of the components of the drug products
History of hypersensitivity to bevacizumab or murine products, temsirolimus or its metabolites, or any component of the formulation
Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX) if receiving T-cell depleted (soybean lectin agglutination [SBA]-E)- bone marrow, or chicken egg products
Known hypersensitivity to GM-CSF, yeast-derived products or any component of the GM-CSF drug product (e.g., mannitol) or poly-ICLC (e.g., carboxymethylcellulose).
Patients may not use natural herbal products or other “folk remedies” while participating in this study
History of hypersensitivity to bevacizumab, murine products, or any component of the formulation
Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh
DONOR: Donors with a known allergy to E. coli-derived products are ineligible for mobilization with G-CSF; alternatives may be used and would have to be discussed individually in these rare circumstances
History of hypersensitivity reactions to murine protein-containing products
Hematopoietic growth factors, transfusions of blood or blood products within 1 week
Therapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medication
Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, calcium, or vitamin D)
Hematopoietic growth factors, transfusions of blood or blood products within 1 week
Subjects who are current smokers or users of other tobacco products or have quit <90 days before first dose of study drug
Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates
Patients must be willing to receive transfusions of blood products
Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules
Known sensitivity to any of the products that will be administered during the study
At least 2 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational products
Patient has a known allergy to bovine or porcine products.
Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
Agreement not to donate blood or blood products during the study and for 7 months after discontinuation of vismodegib
Has no known allergy to murine products or positive human anti-mouse antibody (HAMA)
Has no known allergy to murine products or positive HAMA
Refusal to receive allogenic transfusion of blood-derived products.
Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
A history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products
Adequate availability of sickle trait negative, leukoreduced, Blood type (ABO) blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement RBC products.
Subjects who refuse blood products.
Hypersensitivity to cytarabine, daunorubicin or liposomal products
Treatment with any anticancer therapy or any investigational products within 3 weeks before the first dose of study drug.
Treatment with any systemic antineoplastic therapy or investigational products within 21 days before the first dose of study treatment.
Known hypersensitivity to filgrastim, plerixafor, or Escherichia (E.) coli derived products
Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
Agreement not to donate blood or blood products or to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib
Treatment with any investigational products 21 days prior to treatment
PART I: Participants who smoke tobacco products will not be allowed to participate
PART II: Those who smoke tobacco products will not be allowed to participate
Subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug
Treatment with any investigational products
Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Exposure to more than 4 investigational medicinal products within 12 months prior to the first dose of study treatment
Willingness to avoid the ingestion of grapefruit and Seville oranges (as well as other products containing these fruits, e.g. grapefruit juice or marmalade) during the study, as these may affect selumetinib metabolism
Patients with a known hypersensitivity to any of the components of the drug products
Any prior exposure to gene vector delivery products
DONOR: Has not donated blood products to patient
Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Subjects must not be currently using other tobacco or nicotine products.
Allergies to eggs, lecithin or soy products.
History of hypersensitivity to doxil, doxorubicin, hydrochloride (HCL), temsirolimus or its metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
Subject has known sensitivity to any of the products to be administered during dosing
Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
Hypersensitivity to cytarabine, daunorubicin or liposomal products
Investigational products or therapy other than ASP8273
Therapy with any investigational products within 21 days before the first dose of study drug
Patients must be willing to receive transfusions of blood products
Patients with known systemic allergy to bovine or murine products
Within the 30 days before registration, no use of: 1) any pharmacologic treatment for smoking cessation, including bupropion or nicotine replacement therapy; 2) any nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in any formal behavioral treatment program for tobacco dependence as determined by patient report
Regular use of tobacco products other than cigarettes
Previous treatment with pathogen-reduced blood products
Known or suspected allergy to pamidronate or related products
Patients with known allergies to egg products, neomycin, or tetanus toxoid
Subjects with personal or family history of QT prolongation, uncorrected electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and those taking antiarrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities; relevant information will be collected during medical history taking
DONOR: has not donated blood products to patient
Lactose intolerance or intolerance to milk products
Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, high doses of caffeine, guarana, or anything called an “adaptogen”)
Willingness to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
Allergy to bovine collagen products
Patients with documented allergy to egg products.
Patients with documented allergy to soy products.
Extensive history of using smokeless tobacco products or marijuana defined as daily use >= 5 years
Patients with hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products
Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream
Use of any estrogen containing medications, products, or preparations
Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
Abstention from meat and other animal products
Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 1 month
Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Consumed grapefruit juice or grapefruit containing products within 7 days of the first planned ranolazine dose
Current use of tobacco/tobacco-containing products;
Transfusion of blood products or intravenous immune globulin within 3 months of study entry
Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g., mannitol)
Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel; access to a personal computer\r\n* In general Android, Apple products and Windows 10 phones or any phone with Bluetooth Smart, will run Garmin Connect; (iPhone 5,5s,6,6s,7,7+; most recent Motorola, Samsung, Google Nexus, Sony, and Nokia products)
Exclusive use of tobacco products other than cigarettes, such as (but not limited to) cigars, chew, snuff, pipe or electronic (e)-cigarettes (cigs).
Not be allergic to tomato or tomato products
Not be allergic to soy or soy related products
Used other tobacco products (including e-cigarettes) more than 9 days in the past month
History of allergy to eggs, egg products, aminoglycoside antibiotics
Willing to abstain from cannabis and other tobacco products during study procedures
Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
History of hypersensitivity reactions to murine protein-containing products
Have a known allergy or food intolerance to ingredients in study products (black raspberries or other berries)
Smoker or uses smokeless tobacco products
Use of tobacco products other than cigarettes in past 30 days
Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products
Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
Patient has used a probiotic dietary supplement within the previous 30 days of enrollment; (consumption of yogurt products is allowed)
Known sensitivity to any of the products to be administered during the study (e.g., calcium or vitamin D)
Known allergy to eggs, egg products
Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products
Subjects with known sensitivity to any device or products required for the RALP surgery; and
STUDY I: Former dual users who have quit both products
Agreement not to donate blood or blood products during the study and for 7 months after the last dose
Allergic to fish products
Use of tobacco products other than cigarettes in past 30 days
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
PATIENT: Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock (subjects with non-anaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour [h] following the administration of Sonazoid)
Hypersensitivity to potassium iodide or Lugols products
Hypersensitivity to iodide products
No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses; allergy to personal care/consumer products or their ingredients
Received other investigational products or therapy in the 60 days prior to study drug administration.
Patients with known sensitivities to albumin, blood, or blood products
Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
Use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes
Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes) or use of these products within 3 months of study registration
Use of any aspirin-containing products or other non-steroidal anti-inflammatory drugs (NSAIDs) (>= 2 days per week on a regular basis)
Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months
Currently using nicotine replacement or other tobacco cessation products or intention to quit in next three months
Regular use (e.g., greater than weekly) of tobacco products (including e-cigarettes) other than cigarettes
Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes)
Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
Subject has provided written informed consent to participate in the study\n (adolescents under the age of 18 will be excluded because this project involves\n continued use of tobacco products and new tobacco products);
Pregnant or breastfeeding (due to toxic effects from tobacco products).
use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
Subject has known sensitivity to any of the products or components to be administered during dosing.