[c09aa8]: / clusters / clustall9k / 85.txt

Download this file

1447 lines (1446 with data), 159.6 kB

   1
   2
   3
   4
   5
   6
   7
   8
   9
  10
  11
  12
  13
  14
  15
  16
  17
  18
  19
  20
  21
  22
  23
  24
  25
  26
  27
  28
  29
  30
  31
  32
  33
  34
  35
  36
  37
  38
  39
  40
  41
  42
  43
  44
  45
  46
  47
  48
  49
  50
  51
  52
  53
  54
  55
  56
  57
  58
  59
  60
  61
  62
  63
  64
  65
  66
  67
  68
  69
  70
  71
  72
  73
  74
  75
  76
  77
  78
  79
  80
  81
  82
  83
  84
  85
  86
  87
  88
  89
  90
  91
  92
  93
  94
  95
  96
  97
  98
  99
 100
 101
 102
 103
 104
 105
 106
 107
 108
 109
 110
 111
 112
 113
 114
 115
 116
 117
 118
 119
 120
 121
 122
 123
 124
 125
 126
 127
 128
 129
 130
 131
 132
 133
 134
 135
 136
 137
 138
 139
 140
 141
 142
 143
 144
 145
 146
 147
 148
 149
 150
 151
 152
 153
 154
 155
 156
 157
 158
 159
 160
 161
 162
 163
 164
 165
 166
 167
 168
 169
 170
 171
 172
 173
 174
 175
 176
 177
 178
 179
 180
 181
 182
 183
 184
 185
 186
 187
 188
 189
 190
 191
 192
 193
 194
 195
 196
 197
 198
 199
 200
 201
 202
 203
 204
 205
 206
 207
 208
 209
 210
 211
 212
 213
 214
 215
 216
 217
 218
 219
 220
 221
 222
 223
 224
 225
 226
 227
 228
 229
 230
 231
 232
 233
 234
 235
 236
 237
 238
 239
 240
 241
 242
 243
 244
 245
 246
 247
 248
 249
 250
 251
 252
 253
 254
 255
 256
 257
 258
 259
 260
 261
 262
 263
 264
 265
 266
 267
 268
 269
 270
 271
 272
 273
 274
 275
 276
 277
 278
 279
 280
 281
 282
 283
 284
 285
 286
 287
 288
 289
 290
 291
 292
 293
 294
 295
 296
 297
 298
 299
 300
 301
 302
 303
 304
 305
 306
 307
 308
 309
 310
 311
 312
 313
 314
 315
 316
 317
 318
 319
 320
 321
 322
 323
 324
 325
 326
 327
 328
 329
 330
 331
 332
 333
 334
 335
 336
 337
 338
 339
 340
 341
 342
 343
 344
 345
 346
 347
 348
 349
 350
 351
 352
 353
 354
 355
 356
 357
 358
 359
 360
 361
 362
 363
 364
 365
 366
 367
 368
 369
 370
 371
 372
 373
 374
 375
 376
 377
 378
 379
 380
 381
 382
 383
 384
 385
 386
 387
 388
 389
 390
 391
 392
 393
 394
 395
 396
 397
 398
 399
 400
 401
 402
 403
 404
 405
 406
 407
 408
 409
 410
 411
 412
 413
 414
 415
 416
 417
 418
 419
 420
 421
 422
 423
 424
 425
 426
 427
 428
 429
 430
 431
 432
 433
 434
 435
 436
 437
 438
 439
 440
 441
 442
 443
 444
 445
 446
 447
 448
 449
 450
 451
 452
 453
 454
 455
 456
 457
 458
 459
 460
 461
 462
 463
 464
 465
 466
 467
 468
 469
 470
 471
 472
 473
 474
 475
 476
 477
 478
 479
 480
 481
 482
 483
 484
 485
 486
 487
 488
 489
 490
 491
 492
 493
 494
 495
 496
 497
 498
 499
 500
 501
 502
 503
 504
 505
 506
 507
 508
 509
 510
 511
 512
 513
 514
 515
 516
 517
 518
 519
 520
 521
 522
 523
 524
 525
 526
 527
 528
 529
 530
 531
 532
 533
 534
 535
 536
 537
 538
 539
 540
 541
 542
 543
 544
 545
 546
 547
 548
 549
 550
 551
 552
 553
 554
 555
 556
 557
 558
 559
 560
 561
 562
 563
 564
 565
 566
 567
 568
 569
 570
 571
 572
 573
 574
 575
 576
 577
 578
 579
 580
 581
 582
 583
 584
 585
 586
 587
 588
 589
 590
 591
 592
 593
 594
 595
 596
 597
 598
 599
 600
 601
 602
 603
 604
 605
 606
 607
 608
 609
 610
 611
 612
 613
 614
 615
 616
 617
 618
 619
 620
 621
 622
 623
 624
 625
 626
 627
 628
 629
 630
 631
 632
 633
 634
 635
 636
 637
 638
 639
 640
 641
 642
 643
 644
 645
 646
 647
 648
 649
 650
 651
 652
 653
 654
 655
 656
 657
 658
 659
 660
 661
 662
 663
 664
 665
 666
 667
 668
 669
 670
 671
 672
 673
 674
 675
 676
 677
 678
 679
 680
 681
 682
 683
 684
 685
 686
 687
 688
 689
 690
 691
 692
 693
 694
 695
 696
 697
 698
 699
 700
 701
 702
 703
 704
 705
 706
 707
 708
 709
 710
 711
 712
 713
 714
 715
 716
 717
 718
 719
 720
 721
 722
 723
 724
 725
 726
 727
 728
 729
 730
 731
 732
 733
 734
 735
 736
 737
 738
 739
 740
 741
 742
 743
 744
 745
 746
 747
 748
 749
 750
 751
 752
 753
 754
 755
 756
 757
 758
 759
 760
 761
 762
 763
 764
 765
 766
 767
 768
 769
 770
 771
 772
 773
 774
 775
 776
 777
 778
 779
 780
 781
 782
 783
 784
 785
 786
 787
 788
 789
 790
 791
 792
 793
 794
 795
 796
 797
 798
 799
 800
 801
 802
 803
 804
 805
 806
 807
 808
 809
 810
 811
 812
 813
 814
 815
 816
 817
 818
 819
 820
 821
 822
 823
 824
 825
 826
 827
 828
 829
 830
 831
 832
 833
 834
 835
 836
 837
 838
 839
 840
 841
 842
 843
 844
 845
 846
 847
 848
 849
 850
 851
 852
 853
 854
 855
 856
 857
 858
 859
 860
 861
 862
 863
 864
 865
 866
 867
 868
 869
 870
 871
 872
 873
 874
 875
 876
 877
 878
 879
 880
 881
 882
 883
 884
 885
 886
 887
 888
 889
 890
 891
 892
 893
 894
 895
 896
 897
 898
 899
 900
 901
 902
 903
 904
 905
 906
 907
 908
 909
 910
 911
 912
 913
 914
 915
 916
 917
 918
 919
 920
 921
 922
 923
 924
 925
 926
 927
 928
 929
 930
 931
 932
 933
 934
 935
 936
 937
 938
 939
 940
 941
 942
 943
 944
 945
 946
 947
 948
 949
 950
 951
 952
 953
 954
 955
 956
 957
 958
 959
 960
 961
 962
 963
 964
 965
 966
 967
 968
 969
 970
 971
 972
 973
 974
 975
 976
 977
 978
 979
 980
 981
 982
 983
 984
 985
 986
 987
 988
 989
 990
 991
 992
 993
 994
 995
 996
 997
 998
 999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075
1076
1077
1078
1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132
1133
1134
1135
1136
1137
1138
1139
1140
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189
1190
1191
1192
1193
1194
1195
1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208
1209
1210
1211
1212
1213
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246
1247
1248
1249
1250
1251
1252
1253
1254
1255
1256
1257
1258
1259
1260
1261
1262
1263
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284
1285
1286
1287
1288
1289
1290
1291
1292
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311
1312
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322
1323
1324
1325
1326
1327
1328
1329
1330
1331
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341
1342
1343
1344
1345
1346
1347
1348
1349
1350
1351
1352
1353
1354
1355
1356
1357
1358
1359
1360
1361
1362
1363
1364
1365
1366
1367
1368
1369
1370
1371
1372
1373
1374
1375
1376
1377
1378
1379
1380
1381
1382
1383
1384
1385
1386
1387
1388
1389
1390
1391
1392
1393
1394
1395
1396
1397
1398
1399
1400
1401
1402
1403
1404
1405
1406
1407
1408
1409
1410
1411
1412
1413
1414
1415
1416
1417
1418
1419
1420
1421
1422
1423
1424
1425
1426
1427
1428
1429
1430
1431
1432
1433
1434
1435
1436
1437
1438
1439
1440
1441
1442
1443
1444
1445
1446
Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must have completely recovered from any previous surgery prior Cycle 1 Day-2).
Major surgery within 28 days before Cycle 1 Day 1
Major surgery within 14 days prior cycle 1, day 1
Has had major surgery within 21 days before cycle 1, day 1
Has had major surgery within 21 days before cycle 1, day 1.
Major surgery within 4 weeks prior to cycle 1, other than for diagnosis.
Recent major surgery (within 6 weeks prior to the start of cycle 1, day 1) other than for diagnosis
Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation of needing such procedure while receiving study treatment
A minimum of 4 weeks from any major surgery prior to cycle 1 day 1
History of recent major surgery within 6 weeks prior to the start of cycle 1, day 1 other than for diagnosis
Patients who have had major surgery within 21 days before cycle 1, day 1
Has had major surgery within 21 days before cycle 1, day 1
Major surgery within four weeks before cycle 1 day 1
Planned major surgery during the study or within 4 weeks of Cycle 1, Day 1
Subject has received prior therapy for cancer or major surgery within 28 days, or 42 days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1, or 14 days for tamoxifen;
Recent major surgery within 4 weeks prior to Cycle 1, Day 1, other than superficial lymph node biopsies for diagnosis
Has had major surgery within 21 days before cycle 1 day 1
Major surgery within 28 days before Cycle 1 Day 1
Patients with recent major surgery within 14 days prior to cycle 1, day 1
Major surgery within three weeks before cycle 1 day 1
Received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib (Day 1, Cycle 1).
Major surgery or radiation therapy within 4 weeks of cycle 1, day 1
No major surgery within 14 days and minor surgery within 7 days prior to cycle 1 day 1
Major surgery within 14 days and minor surgery within 7 days prior to cycle 1 day 1
Major surgery within 4 weeks from cycle # 1
Major surgery within 2 weeks before cycle 1 day 1
Major surgery within 28 days before Cycle 1 Day 1
Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1), other than for diagnosis
Major surgery within 4 weeks, or minor surgery within 2 weeks prior to day 1 of cycle 1
Major surgery within four weeks before cycle 1, day 1
Patient received radiation therapy or major surgery within one month of Cycle 1 Day 1
Major surgery within 28 days before Cycle 1 Day 1
Major surgery within 30 days prior to enrollment.
Major surgery ?28 days or major radiation therapy ?14 days prior to enrollment.
Major surgery within 4 weeks of enrollment
Major surgery within 14 days before enrollment
Major surgery within 6 weeks of enrollment
Major surgery within 14 days before enrollment
Major surgery within 4 weeks before enrollment
Major surgery within 14 days before enrollment
Prior chemotherapy and/or immunotherapy within 14 days before enrollment; major surgery within 14 days before enrollment and minor surgery within 7 days prior to cycle 1 day 1
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Patients with major surgery within 28 days prior to trial enrollment
Major surgery within 1 month prior to enrollment
Major surgery within 28 days of enrollment.
Patients who had undergone any major surgery within 4 weeks of study enrollment
Major surgery within 4 weeks prior to enrollment
Major surgery within 2 months before enrollment; complete healing from major surgery must have occurred 1 month before enrollment; complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment; subjects with clinically relevant complications from prior surgery are not eligible
Major surgery within 14 days before enrollment
Major surgery within 4 weeks of enrollment
Any major surgery within 21 days prior to enrollment
Prior major surgery or gastrointestinal perforation within 28 days of enrollment
No major surgery within 4 weeks prior to enrollment
Major surgery: only patients who are not anticipated to need major surgery within the next 3 months of enrollment are eligible
Major surgery* within 28 days before enrollment.
Major surgery within 1 month prior to enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
At least 30 days from major surgery before study enrollment, with full recovery
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Has had major surgery within 3 weeks prior to enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Surgery within 3 weeks prior to enrollment
Major surgery within 21 days prior to enrollment
Must have had no major surgery within 28 days prior to enrollment.
Patients who have had major surgery within 6 weeks of enrollment in the study
Major surgery within 14 days before enrollment.
Major surgery within 30 days prior to enrollment.
Major surgery within 4 weeks prior to study enrollment.
Major surgery within 1 month prior to enrollment.
Patients who have undergone major surgery within 4 weeks prior to study enrollment
Major surgery within 14 days before enrollment
Has had major surgery within 2 weeks prior to enrollment
Major surgery or trauma within four weeks before enrollment.
Have had any major surgery within four weeks of enrollment.
Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment
Major surgery within 4 weeks prior to enrollment
Patients that have undergone major surgery within the last 4 weeks before enrollment;
Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.
Major surgery within 30 days prior to enrollment.
Major surgery within 4 weeks of enrollment
Major surgery within 4 weeks of enrollment
Major surgery within 14 days prior to enrollment
Last surgery > 10 weeks from enrollment
Surgery less than two weeks before enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Has had major surgery within 28 days prior to enrollment
Patients who have undergone major surgery within 2 weeks prior to study enrollment or who have not recovered from a major surgery
COHORT A: Major surgery within 4 weeks of enrollment (week 1 visit)
COHORT B: Major surgery within 4 weeks of enrollment (week 1 visit)
Prior major surgery less than 14 days prior to enrollment. Any surgery-related AE(s) must have resolved prior to enrollment
Major surgery within 1 month prior to enrollment.
Major surgery within 4 weeks prior to study enrollment.
No major surgery within 4 weeks prior to enrollment
Major surgery or radiation therapy within 4 weeks of enrollment
Patients who have had any major surgery within 21 days prior to enrollment
Major surgery within 28 days prior to enrollment or still recovering from prior surgery
No major surgery or radiation in the prior 4 weeks prior to enrollment
Major surgery within 7 days of enrollment
Major surgery within 4 weeks of enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Major surgery within 14 days before enrollment
Major surgery within 1 month prior to enrollment
Major surgery within 4 weeks prior to study enrollment
Prior major surgery or radiation therapy within 4 weeks of enrollment;
Patients who have had major surgery within 4 weeks of enrollment
Patients who have had major surgery within 14 days of study enrollment
Major surgery within 4 weeks of study enrollment
Major surgery within 28 days prior to enrollment or still recovering from prior surgery
Major surgery ? 28 days prior to enrollment.
Prior brain surgery =< 14 days prior to enrollment
Major surgery within 28 days prior to enrollment.
Major surgery within 28 days prior to enrollment.
No major surgery within 2 weeks prior to signing of study enrollment
Major surgery within 14 days before enrollment
Patient has had major surgery within 14 days prior to enrollment
No surgery in the last 2 weeks prior to study enrollment
Major surgery, including craniotomy, within 14 days before enrollment
Major surgery . 28 days prior to enrollment.
Major surgery within 28 days of the first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks before the first dose of study drug
Major surgery within 28 days prior to initiation of study drug.
Major surgery within 2 months before planned first dose of study drug
Prior major treatment-related surgery completed at least 4 weeks prior to study drug administration;
Major surgery within 2 weeks of the first dose of study drug
Has had major surgery within 4 weeks before first study drug administration
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Any major surgery within 4 weeks prior to the first dose of study drug.
Major surgery or radiation therapy within 14 days before study drug administration
CRITERIA SPECIFIC FOR COHORT #2 (MCL): Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Major surgery within 2 weeks prior to first dose of study drug
Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during the study period
Major surgery within 4 weeks of initiation of study drug
Major surgery within 28 days prior to first dose of study drug
Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period
Major surgery within 2 weeks prior to registration or first dose of drug
Subject has had major (per Investigator discretion) surgery, with the exception of tumor resection, within 21 days from first dose of study drug.
Major surgery (including opening of the abdomen, chest, or skull) within 21 days of the first dose of study drug.
Major surgery within 2 weeks prior to first dose of study drug
Major surgery within 2 weeks of first dose of study drug
Undergone major surgery within 14 days of the initial dose of study drug
Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug
Major surgery within 4 weeks of initiation of study drug
Major surgery less than 6 weeks prior to the first dose of study drug; minor surgery less than 4 weeks prior to the first dose of study drug
Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks before first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Subjects who have had major surgery (such as nephrectomy) or chemotherapy within 2 weeks prior to first dose of drug
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of drug administration
Major surgery within 14 days before the first dose of study drug
Major surgery within 14 days before the first dose of study drug and have not recovered fully from any complications from surgery.
Had major surgery within 4 weeks prior to study drug treatment.
Major surgery within 4 weeks of first dose of study drug
Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period
Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
Major surgery within 4 weeks of first dose of study drug
Subjects who have had major surgery within 2 weeks prior to first dose of drug
Major surgery within 28 days of the first dose of study drug
Major surgery within 8 weeks of study enrollment or planned major surgery during study and up to 6 months after discontinuation of study drug
Major surgery within 4 weeks of first dose of study drug
Has had major surgery to liver or other site within 4 weeks prior to the first dose of study drug.
Major surgery within 4 weeks prior to first dose of study drug.
Major surgery within 4 weeks before first dose of study drug.
Major surgery within 4 weeks before first dose of study drug.
major surgery within 4 weeks of first dose of study drug
Major surgery within 28 days prior to first dose of study drug
Major surgery within 4 weeks of the first dose of study drug
Major surgery within 4 weeks of first dose of study drug
Major surgery, within 28 days of first dose of study drug
Major surgery within 4 weeks before the first dose of study drug.
Major surgery within 28 days of study drug
Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
Major surgery within 4 weeks of first dose of study drug.
Major surgery within 4 weeks of first dose of study drug
Major surgery within 14 days before first dose of study drug
Major surgery within six weeks or open biopsy within 14 days before drug infusion.
Trauma or major surgery within 4 weeks of first study drug administration
Major surgery within 4 weeks of first dose of study drug
Major surgery within 2 weeks of study drug administration
Had major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of the first dose of study drug.
Major surgery within 4 weeks prior to first study drug administration
Subjects that have undergone major surgery within 4 weeks prior to the first dose of study drug are not eligible
At least 4 weeks must have elapsed from major surgery prior to starting study drug
No major surgery within the last 4 weeks (28 days) of first dose of study drug or minor surgery within 3 days of first dose of study drug
Major surgery within 4 weeks before first dose of study drug.
Major surgery within the 28 days preceding the first dose of study drug
Major surgery within 3 weeks before the first dose of study drug.
Major surgery within 14 days before the first dose of study drug
Major surgery or radiation therapy within 4 weeks before first study drug administration.
Major surgery planned within 4 weeks of the first dose of study drug
Major surgery within 3 weeks prior to first study drug administration.
Major surgery within 14 days prior to the first dose of study drug
Major surgery within 28 days prior to the first dose of study drug.
Major surgery within 4 weeks of 1st dose of study drug
Major surgery within 28 days prior to the first dose of study drug.
Major surgery within 4 weeks of first dose of study drug.
Major surgery within 28 days of first dose of study drug
9. Major surgery within 28 days prior to the first dose of study drug.
Major surgery within 4 weeks of initiation of study drug
Major surgery within six weeks or open biopsy within 14 days before drug infusion.
Major surgery ? 21 days from beginning of study drug
Major surgery within 14 days before the first dose of study drug.
Major surgery within 2 weeks before the first dose of either study drug
Major surgery within 28 days before the first dose of study drug
Prior major surgery or trauma within 28 days before first dose of study drug
Major surgery within 14 days before the first dose of study drug
Major surgery or radiotherapy within 14 days before study drug administration
Major surgery within 14 days before the first dose of study drug
Major surgery or significant trauma within 2 weeks prior to the first dose of study drug.
Major surgery or radiotherapy within 14 days before the first dose of study drug
Has major surgery or radiotherapy within 14 days before the first dose of study drug
Major surgery within 14 days of initiation of study drug treatment
The subject has had prior major surgery within 30 days prior to first dose of study drug
Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
Prior major surgery within 4 weeks of starting study drug administration
Trauma or major surgery within 4 weeks of first study drug administration
Major surgery within 28 days prior to first dose of study drug.
Major surgery within 4 weeks of first dose of study drug
Major surgery within 4 weeks of first dose of study drug
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Major surgery within 4 weeks of first dose of study drug
Had major surgery within 4 weeks before study drug treatment
Major surgery within 4 weeks of first dose of study drug
History of severe trauma or major surgery within 4 weeks prior to the initiation of study drug administration.
Major surgery within 28 days of first drug dose
Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
Current use of natural herb products or other complementary alternative medications; if used previously, patients must have at least 1-week washout and must stop using them while participating in this study
Patients must also be offered participation in banking for future use of specimens
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
Use of over the counter (OTC) PPIs within 6 months prior to study entry\r\n* Esomeprazole (Nexium)\r\n* Lansoprazole (Prevacid)\r\n* Omeprazole (Prilosec, Zegerid)
Thrombolytic use within 10 days prior to first day of study therapy
Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
Concurrent use of medications contra-indicated due to potential interactions with phenelzine
Acetaminophen use within 24 hours before a dose of gedatolisib (PF-05212384)
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir)
Use of T cell depletion either ex vivo or in vivo (i.e. ATG, alemtuzumab) is prohibited.
Prior use of natalizumab for any reason is not allowed
Use of any myeloma-specific therapy within 21 days of the MILs collection
Concomitant use of the following drugs: antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone; if the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives
Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.
Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.
Prior treatment with enzalutamide for CPRC; non-CRPC use is allowed (e.g., neoadjuvant, combined with radiation for localized disease and didn’t progress while on it in those settings)
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
Known life-threatening reaction (i.e., anaphylaxis) to Thymoglobulin® that would prohibit use for the patient as this study requires use of the Thymoglobulin® preparation of ATG.
Patients requiring prolonged treatment with fluconazole, voriconazole, or posaconazole; use of isavuconazonium sulfate, liposomal amphotericin, are echinocandins are permitted
Have not used exogenous hormone replacement therapy or oral contraception in the year prior to diagnosis; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Participants receiving antibiotic therapy for treatment of a bacterial infection or bacterial prophylaxis upon admission for allogeneic HSCT; use of any agent (e.g. sulfamethoxazole/trimethoprim) for prophylaxis of pneumocystis jirovecii pneumonia is permitted; concurrent use of anti-fungal and anti-viral therapies is also permitted
Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Use of antidepressants such as sertraline within 6 weeks OR use of paroxetine, fluoxetine, or citalopram within 3 months prior to registration
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
No active tobacco use (> 10 years tobacco free interval, < 20 pack/year [pk/yr.] history)
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, methamphetamine)
The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled central nervous system (CNS) leukemia. (2) use of hydroxyurea and/or one dose of cytarabine (up to 2 g/m^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine
Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
Active illicit drug use or diagnosis of alcoholism.
Patient must discontinue any and all use of multivitamin and/or vitamin c medication 24 hours before first dose of ascorbic acid
Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of HSIL at any point, use of intra-anal or topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of condyloma within 6 months prior to randomization or perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5% within 6 months prior to randomization
Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery.
Use of vasopressors within 7 days prior to Day 1
Willing to discontinue or not initiate the use of prophylactic hemin throughout the study.
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride
Use of dutasteride within 90 days prior to therapy; PSA should not be obtained prior to 90 days after stopping dutasteride
Patients with viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use are ineligible
Active illicit drug use or diagnosis of alcoholism
Patients receiving anti-herpes medication (i.e., acyclovir, famciclovir, or valacyclovir) within 1 week prior to initiating HF10 treatment; patients may not require intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug other than intermittent topical use
Use of OsteoCool in vertebral body levels C1-C7
Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy; patients will not be excluded solely based on prior use of debulking agent; prior or current use of leukapheresis will be allowed
Any other condition that may not allow safe use of chemotherapy based on the clinical judgment of the treating oncologist
Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 14 days prior to planned start of therapy
Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
Require intermittent or chronic treatment with an intravenous or oral antiherpetic drug (e.g., acyclovir), other than intermittent topical use
No prior use of ketoconazole for greater than 7 days
Has used any investigational drug (including marketed drugs not approved for this indication) ? 14 days of C1D1. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved, returned to baseline or stabilized.
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry\r\n* NOTE: recent or current use of inhaled steroids is not exclusionary; if subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days; isolated use of steroids as premedication for medical procedures to minimize allergic reaction e.g. CT scan dye are allowed
To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded
Patients receiving, or unable to stop use at least 1 week prior to receiving the first dose of BMX-001, medications listed in Section 12.2 of the protocol are not eligible.
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; use of immunosuppressant drugs such as systemic steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc.: systemic use is not permitted within 4 weeks before recruitment
History of autoimmune disorder with exception of eligible patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation; use of immunosuppressant drugs such as steroids (except as hormone replacement therapy), azathioprine, tacrolimus, cyclosporine, etc. is not permitted within\r\n4 weeks before recruitment
Prior use of levothyroxine
Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
The use of natural or synthetic cannabinoids
Any prior use of Revlimid or Velcade
Planned use of maintenance or consolidative therapy
Prior use of ARN-509 (apalutamide)
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
Use of amiodarone within 90 days prior to first dose
Use of any anti-leukemic agents after relapse is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance) for cohorts 1 and 2
Use of amiodarone within 90 days prior to first dose
Reported illicit drug use
Use of medications or supplements that are known to affect PSA within 30 days prior to informed consent, including toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements; no dutasteride within 90 days prior to informed consent
Consumption or use of any Noni or Noni-containing products
Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment\r\n* Note: special considerations for vaccination: study-related treatments may be given after short-term steroid use (=< 4 days) with prior approval by the protocol chair and investigational new drug (IND) sponsor
PHASE I: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, irritable bowel disorder [IBD], muscular sclerosis [M.S.], uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., chronic obstructive pulmonary disease [COPD])\r\n* Known human immunodeficiency virus [HIV]-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
PHASE II: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., COPD)\r\n* Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
Post-prostatectomy use of ADT for > 30 days prior to study entry (ADT defined as the use of a GnRH agonist, with or without an anti-androgen)
Significant urinary obstruction in spite of alpha blocker use (i.e. AUA symptom score > 18)
Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use
Use of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.
Thrombolytic use (except to maintain i.v. catheters) or anticoagulant use within 10 days prior to first day of study therapy
Active drug use or alcoholism
Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed)
Prior use of pegylated interferon or interferon
Use of antiplatelet agents other than low-dose aspirin
Current use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Unwilling to use nicotine replacement therapy (NRT) patches
Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible)
Concurrent use of the selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine (Luvox)
Use of full-dose anticoagulant therapy; use of daily aspirin up to 325 mg per day is permitted
If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours prior to start of study therapy is allowed
Prior use of agents for TNF-alpha blockade
> 10 pack years of tobacco use or more
Active epilepsy or convulsive conditions that require continuous use of anticonvulsants
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
Prior use of duloxetine or milnacipran
Prior use of venlafaxine specifically for treatment of pain (prior use for treatment of other indications, such as hot flashes, is permitted)
Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted
Use of any of the following within the past 14 days: megestrol acetate (Megace), diethyl stilbestrol (DES), or cyproterone acetate, ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 ug/week)
History of anakinra use
Use of any MPN-associated myelofibrosis-directed therapy within 2 weeks prior to study day 1
Patient with concurrent use of complementary or alternative medicines
Planned use of Optune
Prior use of gossypol or AT-101
Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
Use of immunosuppressant medications within 4 weeks of MCLA-117 administration;
Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Concurrent use of phenothiazine and atypical antipsychotics
Willingness to not use illicit drugs during study period including marijuana.
Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
exclude use of acetaminophen or acetaminophen-containing medications from 1 day before to 1 day after completion of treatment. The active metabolite of acetaminophen, N-acetyl-p-benzoquinone imine (NAPQI), is known to block effects of cenersen & use of acetaminophen during treatment with study regimen has been associated with a failure to achieve a response in a past clinical trial of cenersen.
Prior use of SERM
Use of anticoagulant medications
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g. acyclovir), other than intermittent topical use; patients requiring anti-herpetic prophylaxis during chemotherapy are excluded
Use of any drug with histone deacetylase (HDAC) inhibiting activity.
Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation
Use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal hormone therapy [HT] or contraceptives)
Current use of certain concomitant medications due to mechanistic-based platelet toxicities from navitoclax: clopidogrel, ibuprofen, tirofiban and other anticoagulants, drugs or herbal supplements that effect platelet function; NOTE: antiplatelet use is prohibited during the use of navitoclax; subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the principal investigator in conjunction with the medical monitor
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Patients with a planned use of Novo-TTF (Optune) are ineligible
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use
Patients with current use of megestrol acetate (use within 10 days of day 1) will be excluded
Prior use of steroidal antiandrogens (megestrol acetate, cyproterone acetate), AR partial agonists, ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals within 3 months before registration and during administration of study treatment
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 unless is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an anti-herpetic drug, other than intermittent topical use (e.g., acyclovir)
Patients must also be offered participation in banking for future use of specimens
Patients must also be offered participation in banking for future use of specimens
Patients must also be offered participation in banking for future use of specimens
Monoamine oxidase (MAO) inhibitor use within the past 3 weeks or prior evidence of serotonin syndrome
Active autoimmune disease, chronic inflammatory condition, conditions requiring concurrent use of any systemic immunosuppressants or steroids; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded
Use of clobetasol ointment intra-orally at any time during the last 6 weeks period
Prior use of pazopanib (prior use of other kinase inhibitors allowed)
Must not have retinal or visual field changes from prior 4-aminoquinoline compound use
Use of zidovudine or cobicistat as part of the HAART regimen (a drug substitution at the time of study entry is allowed)
Institutions must seek additional patient consent for the banking and future use of specimens
Use of alemtuzumab
Use of direct acting antivirals for hepatitis C virus (HCV) recurrence, with the exception of sofosbuvir and ledipasvir/sofosbuvir
Use of direct acting antivirals for HCV recurrence\r\n* Sofosbuvir and ledipasvir/sofosbuvir are not excluded therapies
Use of T-cell depleting agents
Use of alemtuzumab
Patients must also be offered participation in banking for future use of specimens
Patients must be offered the opportunity to consent to the use of specimens for future research
Use of IUDs are excluded due to increased risks of infection and bleeding in this population. However, IUD inserted prior to consent may remain in place, and a second method of contraception is mandated
Any significant ophthalmologic abnormality. The use of contact lenses is not recommended during the study.
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Patients must also be offered participation in banking for future use of specimens
Use of any of the following within 28 days prior to the first dose of IP:
Prior eribulin use
Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization
Use of the following medications within 6 months prior to EC1169 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive
Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
Injectable disease (ie, suitable for direct injection or through the use of ultrasound [US] guidance) defined as follows:
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Use of biologic response modifiers within 60 days of first dosing
Current use of or =< 4 weeks prior to registration of anti-androgens such as flutamide, estrogens, ketoconazole, finasteride, or megestrol acetate
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Has neutropenia (IBD and steroid use not excluded)
Prior use of lenvatinib
Self-report Timeline Follow-Back (TLFB) indicating current marijuana use >= 4 days/week for >= 1 year
Positive urine tetrahydrocannabinol (THC) dipstick test (> 50ng/mL; indicating marijuana use in the past 48-72 hours)
Motivated to change their marijuana use (>= 1 on a 10-point Likert-type scale)
Subjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents
Willingness and ability to use an electronic diary.
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Be non-smokers (no nicotine use within the last 5 years)
Use of any drugs with pro-cholinergic properties (e.g. donepezil)
Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)
Use more than 3 g/day of acetaminophen
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
History of use of progestins for a period of longer than 3 months for any indication, including endometriosis;
COHORT A: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
COHORT B: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
No prior use of ketoconazole for greater than 7 days
Patients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)
Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy
Current use of megestrol acetate (Use within 10 days of Day 1)
Prior use of any hypomethylating agent or cytarabine
Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid)
Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study. Any patient with an allo-transplant of any kind would be excluded as well. This would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration. Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded.
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
Prior use of any chronic systemic glucocorticoids .
Prior use or participation in a clinical trial of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448), chemotherapy, or immunological agents (e.g., immune modulators, cytokines, vaccines, or antibody-delivered chemotherapy); the use of denosumab for bone metastasis is permitted
Use more than 3 g/d of acetaminophen
Severe infections necessitating use of antibiotics / antivirals during the screening period
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry. NOTE: Recent or current use of inhaled steroids is not exclusionary. If subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days. Use of steroids before apheresis and immune assessment blood draws should be discouraged as it will affect white blood cell function.
Presence of active infection or systemic use of antimicrobials within 72 hours prior to the first injection
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
Regular use of aspirin in excess of 700 mg per week.
Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
Use of cidofovir for bladder instillation
use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
Use of raloxifene for bone health is allowed
Use of nasogastric or gastronomy (G)-tube administration
Prior use of bendamustine for indolent lymphoma allowed if > 2 years, CR to bendamustine and well tolerated with no residual > grade 1 toxicity; no prior use of bendamustine for aggressive lymphoma allowed
Patients must suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinib
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted participants for 18 months after the first dose of study therapy; for the first 60 days post-transplant, recipients should be encouraged to use nonhormonal contraceptives due to the potential adverse effect of hormones on bone\r\nmarrow engraftment
Requirement for drugs, juices and/or herbs strongly inhibit CYP3A4 from within 7 days prior to D1 of alisertib and throughout treatment; NOTE: glucocorticoids are considered inducers of CYP3A4; however, their use is allowed if patient has been taking a continuous dose of no more than 15 mg/day of prednisone (or its equivalent) for at least 1 month prior to D1 of alisertib; in addition, low dose steroid use for the control of nausea and vomiting will be allowed; topical steroid use and inhaled steroids are also permitted
Patients must not have prior visual field changes from prior 4-aminoquinoline compound use
History of prior crizotinib use
Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Avodart, and anti-inflammatory agents
Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
Any regular use of cyclooxygenase-2 (COX-2) inhibitors as defined by 2-3 times per week
Planned use of any treatment for PTCL during the course of the study.
Males (including those who have had a vasectomy) must practice complete abstinence or use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in the PPRMP.
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
No use of PPIs within 5 days before the first dose of alisertib.
No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib.
Received anti-cancer therapy, including antibody, retinoid, or hormonal treatment (except megestrol acetate as supportive care), and radiation, within 3 weeks before dosing. Prior and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin and analogs for neuroendocrine tumors are permitted
Chronic daily treatment with NSAID (occasional use for the symptomatic relief of medical conditions, for example headache or fever is allowed)
No concurrent use of statins (except for pravastatin, if absolutely necessary)
Use of medications that have been linked to the occurrence of torsades de pointes\r\n* Patients will be eligible for the study if they discontinue any of the listed medications two weeks prior to registration and study enrollment\r\n* Stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline and fluoxetine)
Stopped tobacco use for 4 weeks prior to day 1 and during the study
Retinal or visual field changes from prior 4-aminoquinoline compound use such as hydroxychloroquine sulfate, chloroquine phosphate and amodiaquine
Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) or antiandrogen (i.e. flutamide, bicalutamide) within 6 weeks of day 1 of protocol therapy
Use of other medications that may potentially interact with itraconazole within 1 week of study entry
Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
Active use of an epidural catheter
Use more than 3 g/d of acetaminophen
Concurrent use of antiarrhythmics or contraindicated medications (including, but not limited to, cisapride, mesoridazine, pimozide, posaconazole, sparfloxacin, thioridazine)
Subjects should be willing to abstain from use of hormonal therapies (e.g. hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs, and E-string) and chronic NSAID's for the duration of the study (chronic use of NSAID's is defined as a frequency >3 times/week for more than two weeks per year and includes low dose aspirin).
Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed Exclusion Criteria Specific to Obinutuzumab-Containing Cohorts: Hypersensitivity to obinutuzumab
Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
Patients who need to take CYP3A4 inhibitors, such as cyclosporine, sirolimus, tacrolimus, verapamil, danazol, gemfibrozil, ketoconazole, or macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin) will be excluded; prior use of these agents is acceptable, as long as they are stopped at least a week prior to study entry
No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists
Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks
Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed; for patients who have used these medications they must not have used them within 4 weeks prior to registration
Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement because the person is trying to quit; use of bupropion for depression does not exclude the patient from participating; the occasional use of tobacco dependence treatment (e.g., nicotine replacement therapy [NRT]) to avoid using tobacco in public spaces is not considered to be an exclusion criteria
The use of memantine during or following radiation is NOT allowed
Use of bolus is permitted, but not required
Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
Able to use and read a smartphone (iPhone or Android)
Patients who take long acting opioid medication use
Use of the following treatments for erectile dysfunction (ED): penile implants, vacuum pump devices, intra-cavernosal injections
Chronic sustained-release opioid use for > 2 weeks duration pre operation (op) (in the 30 days prior to surgery)
Use of toremifene
Cognitively capable to use the phone unassisted as verified by research staff
Have basic proficiency in the use of a computer, including word processing and email
Current users of potent inhibitors of tamoxifen metabolism must be able to discontinue their use and switch to an alternative medication for the duration of participation, under the advice of their physician; if the physician feels that an alternative medication is not appropriate for the subject and the current medication is medically necessary, the subject will not be eligible; the drugs are listed below; many of these are not in clinical use at the moment; bupropion, celecoxib, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clemastine, clomipramine, clozapine, cocaine, delavirdine, desipramine, diphenhydramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, halofantrine, hydroxyzine, imipramine, isoniazid, ketoconazole, methadone, methimazole, mibefradil, miconazole, nicardipine, paroxetine, pergolide, perphenazine, pioglitazone, pyrimethamine, quinidine, quinine, ranitidine, ritonavir, ropinirole, sertraline, terbinafine, thioridazine, ticlopidine, tranylcypromine, trazodone, tripelennamine
In the critical care unit, or use of mechanical ventilation or use of renal replacement therapy at any time post HCT and prior to administration of ibrutinib
Anticipated need for use of ADM/mesh at the time of implant or implant exchange
Concurrent use of monoamine oxidase inhibiting (MAOI) medication.
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
Patients must not use topical steroids (e.g., hydrocortisone). Topical over-the-counter antibiotics (e.g., Neosporin) and skin protectants (e.g., Vaseline, Aquaphor) for local skin fissures on hands and feet.\r\n* Note: Patients are allowed to use topical medications on other body parts, besides the hands and feet, but must use qtips or gloves for application.
History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
PHASE 1 & 2: Own and use a smartphone or be willing to use a smartphone
Medications felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment; those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM/IIEF-2 21 or lower, which is collected as part of routine care.
Use of the following medications for seven days prior to and during study participation:\r\n* Stimulant medications\r\n* Sleep medications\r\n* Carbamazepine/Tegratol\r\n* Cough/cold medicines (e.g. Dextromethorphan, Triaminic, Robitussin, Vics Formula 44)\r\n* Flunarizine/Sibelium\r\n* Propnolol/Inderal\r\n* Sulpiride\r\n* Pergolide\r\n* Rivastigmine/Exelon\r\n* Carbidopa/levodopa or levodopa\r\n* Ropinirole/Requip\r\n* Nicotine patch
Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or daily narcotic use
Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
Any use of an assisted walking device
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep (e.g., Benadryl, Unisom) during the study period
Are willing and able to use a smartphone or tablet comfortably
Regular use of narcotics
Airway or facial trauma that would hinder the use of a NIPPV mask
Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists
Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
Use of homeopathic medications or probiotics that may impact gut microbiota
Patients must agree not to use any additional estrogen during the five year study period; however, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed
Use of any exogenous estrogen within the preceding four weeks
Use of Erbitux
Any Food and Drug Administration (FDA) contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months
Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group
Use of ginseng capsules for fatigue, within the last 12 months
New use of sleep aids including melatonin =< 30 days prior to registration
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”)
Use of type III antiarrhythmics (e.g. amiodarone)
Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), or androgens during the previous 3 months
Use of over the counter steroid hormonal supplements
Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
Glucocorticoid use is allowed
Caregivers may or may not be receiving pharmacotherapy for depressive symptoms (type, use, and length of use will be treated as a potential confounding variable)
Prior use of oxybutynin during the period in which patient has had hot flashes
Current use of a wearable PAM device as defined by use of PAM device in the last 6 months
Currently on 2 or more antidepressant or anti-anxiety therapies for mood disturbance of any kind; past use is allowed, just not current use
Illicit drug use (excluding recreational marijuana)
Chronic gabapentin, or the similar drug pregabalin, use
Chronic narcotic use (daily or near daily use for > 90 days)
Prior therapy:\r\n* Patients who have undergone 1 previous surgery for tibial pseudarthrosis repair will be eligible to enter the study if they have refracture; use of BMP-2 in the prior surgery is permitted, however patients with prior exposure must be screened for antibodies to BMP-2, bovine collagen, and rhBMP-2 neutralizing antibodies; prior use of BMP-2 is allowed but will be recorded as a possible compounding factor\r\n* Patients who have had 2 or more prior surgeries for pseudarthrosis repair are ineligible
Extensive history of using smokeless tobacco products or marijuana defined as daily use >= 5 years
Caregivers: Willingness to use a smartphone
Use of long acting opioids pre-operatively 28 days prior to day of surgery
Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire, use of antipsychotic medications, and suicidal ideations
Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, dementia, use of antipsychotic medications, suicidal ideations)
Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
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
Use of any systemic oral or parenteral steroid containing medications is not permitted; use of “High Daily Dose” inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than “High Daily Dose” is permitted
Prior history of acupressure use
Use of oral bisphosphonates with a cumulative exposure of more than 1 year
Current acknowledged use of amifostine trihydrate, cholinergic agonist medications (pilocarpine hydrochloride, cevimeline hydrochloride), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function
Able to walk 15 minutes at a time (use of a cane is acceptable)
Current use or use within past two weeks of an monoamine oxidase inhibitor (MAOI)
All patients who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use the urinary drainage bag for an additional period of 4 weeks or more based on the diagnosis
Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
Baseline gabapentin use
Chronic opioid use for over 6 months
Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures
Inability to use a mouse or computer keys to navigate around the computer screen
Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician
Willing to use and return the technology provided by the study
Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.; NOTE: patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study
Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 +/- 2 days through day 28 +/- 2 days)
Medications felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment; those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
Patients unable to use audio or video media due to auditory or ocular dysfunction
Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh
History of finasteride or dutasteride use in the last 6 months
Pregnant women are not eligible as the self-collection device is not recommended for use in this group
Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
Reported use of oral antidiabetic agents (OADs).
SOCIAL MEDIA STUDY: Daily use of Facebook
Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study
Use of chronic laxatives (>= 30 consecutive days)
Use of anti-diarrheal agents (including but not limited to loperamide, octreotide, bismuth, tincture of opium, atropine, probiotics in any form other than food) within the past 7 days
Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Current use of certain medications: \r\n* Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix\r\n* Certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), or \r\n* Other medications listed on the exclusionary medications list
Engaging in three or more intercourse events (defined as having penile-vaginal intercourse) per month; subjects must consent not to douche or use any vaginal products, including tampons, for 24 hours before enrollment and study visits
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Chronic use of omega-3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
Current use of certain medications: (1) smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix, (2) certain medications used to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however as needed (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Use anti-diabetic medication (including insulin)
use of hair dyes
Use of digoxin and licorice
Chronic use of systemic antibiotics; topical lotions which include antibiotics are permitted; occasional use of antibiotics is allowed, but must be stopped for 3 weeks prior to RPFNA and for 3 weeks prior to collecting blood or urine specimens for the pre-study (i.e., prior to dispensing/starting study agent) assessment of lignan levels
Regular consumption of non-prescription anticoagulants, such as aspirin, NSAIDS or fish oil during the 3 weeks prior to baseline RPFNA is strongly discouraged, but occasional use will not exclude subject from participation
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena IUD
Excessive use of acetaminophen or other potentially hepatotoxic drugs
Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively.
Use of medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first veledimex dosing
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator\r\n* Patients treated with any of the medications prohibited must discontinue their use at least 7 days prior to the first dose of romidepsin; certain other agents that interact with the CYP3A4 system may be used with caution
Use of medications that induce, inhibit, or are substrates of cytochrome p450 (CYP450) 3A4 within 7 days prior to veledimex
Planned use of ex vivo or in vivo T-cell depletion
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Willing to use double-barrier protection if sexually active
Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes (CYP3A4), or glutathione S-transferases involved in bortezomib and/or busulfan metabolism during day -5 through day +7. It is acceptable to use alternative non-interacting medications during this period, and then resume prior medications.
Use of laxatives more than 3 times per week
Use anti?platelet agents within two weeks of anticipated sigmoidoscopy
Use of anti?coagulants within two weeks of anticipated sigmoidoscopy
Use of any illicit or illegal substances detected by urinary drug screen
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months
Urinary incontinence requiring condom catheter use or >= 1 pad/day
Immunocompromised (due to conditions including HIV infection, hematopoietic-cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged ?18 years.
the use of one of the following: diaphragm, Lea's shield, FemCap, sponge, and
Prior use of lorlatinib (PF-06463922)
Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
There are any other past medical, physiological or demographic concerns; this includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique
Routine daily use of duloxetine and/or milnacipran
Use of concomitant medications with evidence for an association with drug-induced mitochondrial optic neuropathy including systemic administration of ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, and zidovudine.
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Use of metronidazole or antabuse during the study
Regular use of laxatives (e.g. Ex-lax, Dulcolax, Miralax) that may affect the microbiome >= 2 days a week
Aim 2 only: Smokeless tobacco users who use ST daily (>= 6 dips or pouches/day) for at least 6 months and no other tobacco use or e-cig use for at least 1 year (ST use will be confirmed by salivary cotinine), and in good physical and mental health; no serious quit attempts in the last three months particularly for those randomized to the control condition
Use of inhalant medications
Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months
Use within the last month of nicotine replacement or other tobacco cessation products for purpose of quitting; situational use of nicotine replacement is not a reason for exclusion (to prevent undermining of cessation efforts)
Prior use of degarelix, enzalutamide, trametinib, or dasatinib in any context
Chronic medication use that cannot be safely stopped
Any major radiotherapy, or immunotherapy within the last four weeks; use of erythropoietin replacement or bisphosphonates is considered supportive care and their use is permitted
Patients must be willing to meet four times in person or on the phone to discuss tobacco use
physiologic condition that precludes the use of an oral rinse
Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
Patients who do not own smartphones or who do not use them for more than email, texting and calling
Use of any other medication that could impact dietary intake, such as prednisone
Use or consumption of:
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);
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
Willingness and ability to use the telemonitoring device
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Subject who has undergone platelet receptor GP IIb/IIIa antagonist therapy less than 48 hours prior to surgery.
Subjects must not have received chemotherapy, or undergone major surgery within 2 weeks and radiotherapy within 24 hours prior to enrollment
Subjects must not have received chemotherapy, or undergone major surgery within 2 weeks and radiotherapy within 24 hours prior to enrollment
Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial
Patients must have undergone debulking surgery with peritonectomy and have been allowed at least 4 weeks to recover prior to receiving chemotherapy
interval of ? 14 days between end of surgery and start of protocol therapy for patients who have undergone surgery for recurrent disease.
Subjects who have undergone major surgery within 28 days of study day 1; vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting AMG-232 + KRd
Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
Patients who have undergone major surgery, excluding diagnostic biopsy, within 30 days (to allow for full recovery) prior to registration
Patient has undergone more than 2 debulking surgeries
The patient has undergone major surgery within 28 days prior to first dose of protocol therapy
Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
Has undergone prior surgery at the tumor site or the index tumor has undergone previous surgery or ablation treatment
Subjects having undergone a major surgery within the last 6 weeks
Patients who have undergone major surgery within 14 days
Have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
Patients who have undergone major surgery within 1 month prior to screening.
Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
Patients who have undergone major surgery (including open biopsy, thoracotomy, organ resection, exploratory laparotomy, arteriovenous grafts) < 28 days prior to enrollment will have bevacizumab dosing delayed
Have undergone major surgery within 28 days prior to receiving study drugs.
Patients who have undergone radiation within the past 4 weeks
Patients should NOT have undergone any prior cancer directed surgery (exploration, debulking, etc), with the exception of a minor procedure such as biopsy or cytology specimen
Have undergone a lumpectomy or mastectomy
PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
Patients must have previously undergone or plan to undergo thyroidectomy; for those patients who have previously undergone surgery, pre-operative labs, including complete blood cell count with differential must be available
EXCLUSION - STUDY 1: Undergone surgery in the last 6-8 weeks
Undergone laser corrective eye surgery in the past 30 days
Patients who have not undergone any surgical treatment for their cancer
Patients who have not undergone surgery in the past 6 months; patients may have had neoadjuvant chemotherapy prior to surgery
Has undergone prior ablation treatment of the index tumor
Have undergone surgical debulking
Previously undergone major pelvic surgery
Patients who have undergone a prior tubal ligation will be eligible
Have undergone a lumpectomy or mastectomy
Subjects who have undergone bariatric surgery are not eligible
Subjects who have undergone major surgery ? 2 weeks prior to starting study drugs.
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Subjects who have undergone prior radioembolization
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Patients who have not undergone a visit for cancer surveillance since 2009
Patients must not have received any major surgery or immunotherapy within 28 days prior to registration
No major surgery =< 4 weeks before pre-registration
No major surgery =< 14 days prior to registration
No major surgery within 28 days prior to registration
Patient must have not had any major surgery or radiation within 28 days prior to step 1 registration; diagnostic thoracotomies and laparoscopies are not considered major surgeries
Patients who have undergone major surgery within 4 weeks prior to registration are not eligible
Patients who have had major surgery within 4 weeks prior to registration are not eligible
A minimum of 4 weeks from any major surgery prior to registration
No history of major surgery =< 28 days of registration
Major surgery =< 14 days before study registration
Major surgery other than diagnostic surgery =< 4 weeks prior to registration
Major surgery =< 14 days prior to study registration
Major surgery ? 14 days prior to study registration
Major surgery =< 4 weeks prior to registration
Major surgery within 28 days of registration
Major surgery =< 4 weeks prior to registration
Major surgery =<14 days prior to registration
Major surgery other than diagnostic surgery =< 4 weeks prior to registration
Major surgery =< 4 weeks prior to registration
Major surgery =< 14 days prior to registration
A minimum of 4 weeks from any major surgery prior to registration
Major surgery =< 14 days prior to registration
Patients who have had major surgery within 4 weeks prior to registration are not eligible
Major surgery =< 4 weeks prior to registration
Major surgery =< 14 days before study registration
Major surgery =< 28 days prior to registration
Major surgery =< 4 weeks prior to registration
Patients who have had major surgery within 4 weeks prior to study registration or those who have not recovered from complications from a surgery more than 4 weeks prior to registration
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Major surgery within 4 weeks of registration is prohibited
Major surgery (e.g. thoracic, abdominal, vascular, neurosurgery) within 28 days prior to registration on the study
Major surgery within 4 weeks prior to registration
Major surgery =< 14 days before study registration
Major surgery =< 14 days prior to study registration
Patients who have undergone major surgery within 21 days prior to registration are NOT eligible for participation
Major surgery within 4 weeks of registration
Major surgery =< 3 weeks prior to registration or failure to adequately recover from surgery
Major surgery =< 14 days prior to study registration
Patients who have had major surgery within one month (28 days) prior to registration are not eligible
Major surgery within 28 days (four weeks) prior to registration.
No history of major surgery =< 14 days prior to registration
Major surgery =< 4 weeks prior to registration of the study or who have not recovered from prior surgery regardless of time since surgery
Prior systemic chemotherapy, radiation therapy or major surgery =< 30 days prior to registration
Major surgery =< 28 days prior to registration
Major surgery within 4 weeks of registration
Major surgery, chemotherapy, hormonal or immunologic therapy =< 3 weeks prior to registration
Major surgery =< 4 weeks prior to registration of the study or who have not recovered from prior surgery
Major surgery within 4 weeks of registration is prohibited
Major surgery within 14 days before study registration
Major surgery within 28 days prior to registration
REGISTRATION #2: SURGERY
Any major surgery =< 28 days prior to registration
Major surgery =< 14 days prior to registration
Surgery >= 4 weeks prior to registration
Major surgery within 30 days prior to registration
Major surgery =< 28 days prior to registration
Major surgery other than diagnostic surgery =< 4 weeks prior to registration
Major surgical procedure within 4 weeks prior to planned initiation of study therapy
Major surgery =<4 weeks before first dose of study drug or incomplete recovery from a prior major surgical procedure
Major surgical procedure within 28 days prior to the study.
Major surgical procedure within 4 weeks prior to Day 1
Prior major surgical procedure or radiation therapy within 4 weeks of the randomization
Subject who has undergone a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of KHK2455 or is still recovering from prior surgery;
Prior radiation therapy or chemotherapy within 2 weeks or major surgical procedure within 4 weeks of the first dose of study treatment
Patients who have had radiotherapy or minor surgical procedure within 14 days, or major surgical procedure within 28 days prior to administration of first dose of study drug are not eligible; patients with inadequate recovery from prior surgical procedure are also not eligible
Major surgery within 4 weeks of the first dose of BVD-523; tumor embolization procedure or ablation procedure within 2 weeks of first dose of BVD-523
Major surgical procedure within 28 days prior to Day 1 of Cycle 1.
Must not have undergone a major surgical procedure < 4 weeks prior to registration
Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
Planned surgical procedure within the next 90 days
Major surgical procedure within 4 weeks prior study treatment initiation
Minor surgical procedure within 15 days of study Cycle 1 Day 1
Surgical procedure w/in 4 wks of starting study drug. Or pt has surgery-related complications to Grade ?1
Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
Any planned pleurodesis as part of the surgical procedure.
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment\r\n* Placement of a stent or central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted
Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
Major surgical procedure (as defined by the Investigator) within 14 days prior to the start of study treatment
Patient has had a surgical procedure 4 weeks prior to TURBT or will have other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT
Any major surgical procedure within 4 weeks of first study treatment
Minor surgical procedure within 7 calendar days prior to cycle 1 day 1
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure
Invasive surgical procedure within 28 days prior to study pre-registration
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Major surgical procedure within 4 weeks of first study treatment
Major surgical procedure (as defined by the principal investigator [PI] or co-PIs within 28 days prior to the first dose of durvalumab and tremelimumab or still recovering from prior surgery
Major surgical procedure (e.g. laparotomy, bowel resection) 4 weeks prior to start of the study drug
Must have fully healed from any surgical procedure to be safe for lumbar puncture according to treating neurosurgeon and at least 14 days should have elapsed since the surgical procedure
Major surgical procedure within four weeks prior to administration of the first dose of ARQ 751 a. To be eligible for the study treatment, all surgical wounds must be fully healed and any surgery-related adverse events must recover to Grade ? 1.
previous unilateral thoracic surgical procedure or trauma
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of MEDI4736 and tremelimumab or still recovering from prior surgery
Patients who have had any major surgical procedure within 14 days of day 1
Major surgical procedure within 21 days prior to enrollment
Major surgical procedure within 28 days of study enrollment, or anticipated while on study
Major surgical procedure within four weeks prior to administration of the first dose of study drug • To be eligible for study treatment, all surgical wounds must be fully healed and any surgery-related adverse events (AE) must recover to Grade ? 1
Patients who have had any major surgical procedure within 14 days of Day 1. BM biopsy is not considered a major surgical procedure.
For the purposes of this study, the procedure with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of first registration as the “index procedure” that will be performed during the “index surgery”
Status post \r\n* Elective (curative or palliative) major cancer surgery at the time of the index surgery (patient may have undergone more than one of these procedures) OR \r\n* Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)\r\n** For the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of second registration as the “index procedure” performed during the “index surgery”
Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage
Patients with a major surgical procedure or other investigational agents within 30 days before study enrollment
Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
Patients who have had any major surgical procedure within 14 days of Day 1.
Patients less than 2 weeks post major surgical procedure (all surgical wounds must be fully healed). For the purpose of this criterion, a major surgical procedure is defined as one requiring the administration of general anesthesia
Patients with non-healing surgical wounds; patients must be at least two weeks from a major surgical procedure, and surgical wounds must be completely healed
Optune device application start date must be at least 4 weeks (28 days) from central nervous system (CNS) surgical procedure; excluding ventriculoperitoneal (VP) shunts, endoscopic third ventriculostomy (ETV) for which treatment could start 10 days post procedure; non-CNS surgical procedures such as but not limited to central venous catheter insertion at the discretion of treating physician and study chair
Patients with prior Whipple's procedure.
Patients must have recovered from any surgical procedure before enrolling on this study
Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.
Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
Patients who have had a surgical procedure unrelated to the study within 14 days or major surgery within 1 month prior to the administration of the study drug
Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
Embolization procedure or ablation procedure to treat tumor within 4 weeks of first dose of STA-9090
Major surgical procedure (as defined by the treating physician) within 28 days prior to the first dose of durvalumab and tremelimumab or still recovering from prior surgery
Has not undergone any major surgical procedures for at least 4 weeks, with full healing of all surgical wounds
Non-study related minor surgical procedure =< 5 days, or major surgical procedure =< 21 days, prior to the first dose of rucaparib; in all cases, patients must be sufficiently recovered and stable before treatment administration
Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
Patients who have had any major surgical procedure within 14 days of day 1
Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure
Major surgical procedure less than 4 weeks from start of protocol treatment
Major surgical procedure within 4 weeks of treatment
Major surgical procedure within 4 weeks prior to enrolment.
Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
Major surgical procedure within 4 weeks prior to Study Day 1
Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Major surgical procedure within 30 days prior to Day -31 or still recovering from prior surgery
Anticipate having a major surgical procedure during the course of the study.
Major surgical procedure (as defined by the investigator) within 30 days prior to Study Day 1 or incomplete recovery from any prior surgery.
Requires open spinal procedure or a percutaneous procedure without the use of image guidance
Patients who have had any major surgical procedure within 28 days prior to day 1
Major surgical procedure within 2 weeks prior to starting treatment; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment
Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
Major surgical procedure other than for diagnosis within 28 days prior to D1C1
Major surgical procedure within 21 days prior to the first dose of IP.
Major surgical procedure within 28 days prior to the first dose of Investigational Product;
Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).
Major surgical procedure within 28 days prior to the first dose of Investigational Product
Planned/or anticipated major surgical procedure during the course of the study
Planned surgical procedure that can impact the conduct of the study
Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
Major surgical procedure (as defined by the investigator) within 30 days prior to Day 1 or still recovering from prior surgery.
Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure
Major surgical procedure within 4 weeks
Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure)
Any major surgical procedure or radiation within 4 weeks of first study treatment
Patients less than 4 weeks post major surgical procedure (all surgical wounds must be fully healed); for the purpose of this criterion, a major surgical procedure is defined as one requiring the administration of general anesthesia
Major surgical procedure within 28 days of day 1 of therapy
Major surgical procedure (including periodontal) within 4 weeks
Subject has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study.
Major surgical procedure (other than study related biopsy), or a major surgical procedure is planned to occur during the planned study duration
Subject has had a major surgical procedure (other than study-related biopsy) within 14 days prior to the first dose of study drug, or a major surgical procedure is planned to occur during the study.
Patients who have had any major surgical procedure within 14 days of day 1
Major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery
Radiation therapy or major surgical procedure within 4 weeks of the first dose.
Major surgical procedure within 4 weeks prior to Day 1
A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study.
Major surgery ?4 weeks before first dose of study drug, or incomplete recovery from a prior major surgical procedure
Major surgical procedure within 4 weeks prior to initiation of study treatment
Surgical procedure or clinically significant trauma within 2 weeks of first dose of study treatment
Major surgical procedure within 30 days prior to Day 1 or incomplete recovery from any prior surgery
History of major surgical procedure within 28 days prior to start of study treatment
Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to randomization
Any major surgical procedure within 3 weeks prior to the first dose of study drug;
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Surgical resection or major surgical procedure within 4 weeks prior to the start of SL-701, or stereotactic biopsy within 7 days prior to the start of SL-701.
Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
Major surgical procedure within 4 weeks prior to Day 1
Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first study drug administration.
Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 1 month prior to first study drug administration.
Receiving an organ transplant during the same surgical procedure.
Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Patients who have had a major surgical procedure within the past 6 weeks
Have had a loco-regional procedure for the treatment of hepatocellular carcinoma (such as a percutaneous, trans-arterial, or radio-ablative procedure) less than 4 weeks prior to beginning protocol therapy. Protocol therapy may begin a minimum of 4 weeks after such a procedure provided the following criteria are met:
Major surgical procedure within 90 days
Major surgical procedure within 4 weeks prior to study treatment
Major surgical procedure within 28 days prior to study enrollment
Major surgical procedure within 4 weeks prior to Day 1
Major surgical procedure within 4 weeks prior to Cycle 1, Day 1
Patients must be less than 4 months from the surgical procedure for this recurrence
Major surgical procedure(s) within previous 4 weeks prior to study enrollment
Major surgical procedure within 4 weeks of treatment
Patients who have had any major surgical procedure within 14 days of day 1
A major surgical procedure (other than study related biopsy), or a major surgical is planned to occur during the study
Surgical procedure where both arms are required to be tucked at the patient's side
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Major surgical procedure within 21 days of first study treatment
Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
>= 28 days elapsed from the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity)
Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
Patient is within 2 months of a major surgical procedure
Undergone abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:\r\n* Upper endoscopy\r\n* Surgical esophagectomy
current surgical procedure is a revision surgery for implant failure or infection;
Planned surgical procedure
Definitive breast surgical procedure prior to enrollment.
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Major surgical procedure within 4 weeks of first study treatment
Major invasive surgical procedure occurring between the first treatment-eligible PET/CT examination and end of radiotherapy that would affect the treatment target region
Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
Patient must have recovered from any surgical procedure before enrolling on this study
Patient must not require a major surgical procedure =< 21 days prior to beginning therapy
Patient must not require an intermediate surgical procedure =< 14 days prior to beginning therapy
Prior major surgical procedure or radiation therapy within specified period of the first dose of study treatment (with defined exception).
DYNAMIC COHORT: No clinical plan for biopsy or surgical procedure of known or suspected cancer
Patient must be able to tolerate a major surgical procedure based on clinical evaluation, status of their cancer, and any other underlying medical problems
Prior major surgical procedure or radiation treatment within 2 weeks of initiation of study treatment (not including limited radiation used for palliation of bone pain)
Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
Participant had major surgery within 28 days prior to Study Day 1.
Reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment
Patients who underwent major surgery within 4 weeks before the planned day for the first treatment
Major surgery within 2 months prior to enrollment or minor surgery within 7 days of the first day of treatment
Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
Subject has had major surgery within 28 days prior to study day 1
Major surgery within 28 days of study day 1 with the exception of biopsy and long line insertion
Reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment
Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
Major surgery must have been completed ? 4 weeks prior to starting treatment day 1; patient must be sufficiently recovered and stable from surgery prior to treatment day 1
Patients must have recovered from the effects of surgery per treating physician’s judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
Major surgery within 6 weeks prior to study day 1 (subjects must have completely recovered from any previous surgery prior to study day 1)
Major surgery within 4 weeks prior to enrollment (day 1)
Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment
Major surgery within 28 days prior to day 1 of study treatment from which the patient has not completely recovered
Major surgery within 2 weeks before day 1.
Major surgery other than diagnostic surgery within 28 days of Study Day 1
Any major surgery within 4 weeks or a diagnostic procedure (eg incision, needle biopsy) within 1 day of study drug administration
Major surgery within 4 weeks prior to day 1 of the study or who have not recovered from prior surgery
Major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery from the surgical procedure
Reasonably recovered from preceding major surgery as judged by the Investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment
Major surgery within 6 weeks prior to study day 1 (subjects must have completely recovered from any previous surgery prior to study day 1); biopsy, diagnostic tonsillectomy, airway tumor debulking or excisional lymph node biopsy do not constitute major surgery
Major surgery other than diagnostic surgery within 28 days of Study Day 1
Subject has had major surgery within 28 days prior to study day 1
Major surgery requiring a prolonged hospitalization or recovery within 21 days before day 1 of study drug
Major surgery within four weeks before day 1
Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 7 days must have elapsed prior to the day of protocol treatment
Major surgery within 4 weeks prior to day 1
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
Have major surgery, other than diagnostic surgery, within 4-weeks prior to Day 1
Systemic radiation therapy or major surgery < 28 days prior to study Day 1 as well as focal radiotherapy < 14 days prior to study Day 1.
Major surgery (as defined by the investigator) within the 28 days prior to day 1 of protocol therapy
Major surgery within 4 weeks prior to day 1 of the study or who have not recovered from prior surgery
Major surgery within 2 weeks before day 1
Major surgery within four weeks before day 1
Major surgery within 6 weeks prior to study day 1 (subjects must have completely recovered from any previous surgery prior to study day 1)
Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1).
Subject had a major surgery within 4 weeks prior to day 1.
Major surgery within 4 weeks prior to Day 1 study
Subject has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to day 1 of treatment in this study
Have received prior chemotherapy, other investigational therapy, or major surgery within 4 weeks of Day 1;
Subject has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to day 1 of treatment in this study
Any major surgery within 4 weeks or a diagnostic procedure (e.g. incision, needle biopsy) within 1 day of study drug administration
Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
Major surgery within 28 days of study day 1
Major surgery within 4 weeks prior to enrollment (day 1 visit)
Subjects who had major surgery within 4 weeks of the first day of study drug.
Major surgery within 6 weeks prior to study day 1 (subjects must have completely recovered from any previous surgery prior to study day 1)
Major surgery within four weeks before day -7
Major surgery within 21 days prior to the first day of treatment
Major surgery within 2 weeks before day 1
Major surgery within 4 weeks or minor surgery within 7 days of the first day of study drug dosing
Major surgery < 4 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) < 2 weeks prior to the first day of study defined treatment
Major surgery within 4 weeks prior to enrollment (day 1 visit)
Major surgery within 4 weeks before first day of study drug dosing
Major surgery or radiation therapy within 4 weeks of enrollment (day 1 visit)
Major surgery within 4 weeks of Study Day 1
Major surgery within 3 weeks prior to day 1 of study treatment from which the patient has not completely recovered
Patient has undergone a major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to day 1 of treatment on this study
Major surgery within 28 days of Day 1
Major surgery within 4 weeks prior to day 1 of the study or who have not recovered from prior surgery
Major surgery within three months prior to Day 1 of study or who have not recovered adequately from prior surgery.
Has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days
Major surgery within 4 weeks prior to Day 1 visit.
Major surgery within 28 days of study day 1
Subject has undergone major surgery for any reason, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Cycle 1 Day 1 of treatment in this study.
Major surgery within 4 weeks prior to day 1 of the study or who have not recovered from prior surgery
Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
Patients that have had major surgery =< 3 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) =< 1 week prior to the first day of study defined treatment
At the time of day 1 of the study, patients must be at least 3 weeks since surgery.
Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to day 1 of treatment in this study
Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to day 1 of treatment in this study
Major surgery within 4 weeks prior to day 1
Major surgery within 14 days before day 1.
Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day
Major surgery within 28 days of study day 1
Major surgery within 3 weeks before day 1
Major surgery within 2 weeks before day 1
Major surgery within 21 days before Study Day 1;
Be reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of day 1 treatment
Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
Any major surgery within 4 weeks prior to day 1
Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
Major surgery within 30 days of study day 1
Major surgery, radiotherapy, chemotherapy or investigational agents within four weeks of treatment day 1
Have reasonably recovered from preceding major surgery as judged by the investigator or have had no major surgery within 4 weeks prior to Day 1 treatment.
Have had major surgery within 30 days prior to the start of Day 1;
Use of dexmedetomidine within 28 days prior to day of surgery
Major surgery within 30 days of day 1 of trial
History of major surgery within 30 days prior to trial initiation
Major surgery within 28 days of first dose AMG 757
No major surgery within 30 days of first study treatment.
Have had major surgery or bone fracture within 28 days before first dose of study treatment
Major surgery less than 28 days prior to study entry.
Major surgery within 21 days prior to first dose
Major surgery within 28 days prior to first dose of protocol therapy
Participants must be >= 28 days from any major surgery
Major hemorrhagic event within 28 days
Major surgery within 28 days prior to the first study treatment
Any major surgeries within 28 days.
Major surgery within 28 days prior to treatment or major surgery planned during the next 6 months
Has not had major surgery within 28 days prior to starting study treatment. Central venous access surgeries and/or placements would not be considered as major surgery.
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Major surgery within 21 days of starting protocol treatment
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Major surgery and surgery for brain metastases within 28 days prior to screening start; of note, intravenous port placement is not considered as a major surgery
Major surgery within 28 days of starting study treatment
Major surgery, radiotherapy or infection requiring therapy within 14 days of starting treatment
Patients with major surgery within 30 days prior to entering the study
Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
At least 21 days have passed since major surgery
Any major surgery, chemotherapy or immunotherapy within the last 14 days
Major surgery within 28 days prior to C1D1.
Major surgery within 30 days prior or during the study period
Subject has had major surgery within 21 days prior to the first dose of ABBV-399.
Major surgery within 21 days prior to randomisation
Major surgery within 14 days before enrollment; the PI will serve as the final arbiter as to what constitutes major surgery
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Patients may have received prior surgery provided that at least 28 days have elapsed since major surgery (thoracic or other major surgeries) and the patient has recovered from all associated toxicities. Patients must have disease outside of the previous surgical resection area or a new lesion must be present.
Major surgery within 21 days prior to first dose
Patients with major surgery within 30 days prior to entering the study
Major surgery within 30 days before the initiation of study treatment
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Subject has had major surgery within the last 28 days
Patients who have had major surgery within the past 14 days.
214 Major surgery within 28 days of first dose AMG 562.
Major surgery within 14 days prior to study entry
Major surgery within 28 days prior to first study treatment.
Major surgery within 28 days of C1D1
Major surgery within 21 days of starting protocol treatment
Recent major surgery (within the past 14 days)
Ibrutinib must be discontinued 7 days before (when possible) until 7 days after major surgery, and 3 days before (when possible) until 3 days after minor surgery; thus, patients to be enrolled on an ibrutinib trial must have completed major surgery > 7 days before initiating treatment, and/or must have completed minor surgery > 3 days before initiating treatment
Patients may have received prior surgery (e.g., pleurectomy, pleurodeisis) provided at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment
Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment; tumor biopsy is allowed
The participant underwent major surgery within 28 days.
Major surgery within 21 days of starting protocol treatment
Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
Major surgery within 28 days before randomisation.
Any major surgery, chemotherapy or immunotherapy within the last 21 days
No major surgery within 28 days prior to treatment; no minor surgery within 5 days prior to treatment
Major surgery within 14 days before first dose or a scheduled surgery during study period; insertion of a venous access device (eg, catheter, port) is not considered major surgery.
Known need for major surgery within 14 days of the first dose of Ribociclib. Gastrostomy, insertion of a G tube, Ventriculo-peritoneal shunt, endoscopic ventriculostomy and central venous access are NOT considered major surgery.
Plan for any major surgery during treatment period.
Any major surgery =< 28 days prior to the initiation of investigational products
Subjects enrolling on the ibrutinib arm must not have had major surgery within 14 days, or minor surgery within 7 days
Patients may have received prior surgery (e.g., pleurectomy) provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered (i.e., =< grade 1 or at baseline) from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment
Patients who have undergone major surgery within 7 days or minor surgery within 3 days of first dose of study drug
Major surgery within 30 days before study entry.
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Any major surgery or extensive radiotherapy within 28 days prior to screening
Patients who have had major surgery within 28 days prior to entry into the study or be recovering from any effects of surgery; patients who have had minor surgery within 2 weeks prior to entry into the study
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Major surgery within 28 days prior to the first dose of study medication
Major surgery within 30 days prior to the first dose of study treatment
Major surgery within 21 days prior to signing consent
PART B: Patients who have had major surgery within 28 days prior to entering the study or those who have not recovered from adverse events > grade 1 relating to the surgery
Patients with major surgery within 28 days prior to treatment
Patients with major surgery within 30 days prior to entering the study
Underwent major surgery within 14 days prior to first dose of ponatinib
Patients with major surgery within 30 days prior to entering the study
Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol
Major surgery or trauma occurring within 28 days of starting the trial
Major surgery within 28 days
Major surgery within 30 days of study medication
Major surgery within 21 days prior to the first dose of ABBV-838
Major surgery within 28 days of the first dose of study treatment
Patients may not begin protocol therapy within 7 days of major surgery or within 3 days of minor surgery
Major surgery requiring general anesthesia within 21 days or minor surgery within 14 days of study enrollment; subjects must have recovered from surgery related toxicities
Major surgery within 28 days
Plan for any major surgery during treatment period.
Ibrutinib must be discontinued 7 days before (when possible) until 7 days after major surgery, and 3 days before (when possible) until 3 days after minor surgery; thus, patients to be enrolled on an ibrutinib trial must have completed major surgery within 4 weeks before initiating treatment, and/or must have completed minor surgery > 3 days before initiating treatment
14 days must have elapsed since prior major surgery
Major surgery within 14 days before the first dose of study treatment.
Major surgery within 21 days prior to first dose
The subject had had major surgery within 28 days prior to the first dose of ABT-414.
Major surgery within 30 days
Major surgery within 21 days prior to first dose
Previous major surgery within 28 days prior to enrolment
Patients with major surgery within 30 days prior to entering the study
No major surgery within 28 days of study entry
Patients with major surgery within 28 days prior to treatment
Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy within 28 days of the first scheduled dose of MEDI7247.
Major surgery within <=28 days prior to the first dose of ABBV-085.
Patients who have had major non-biopsy surgery in the last 20 days.
Major surgery other than diagnostic surgery within 28 days
Prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP] and patients with rising PSA after RP), pelvic lymph node dissection, radiation therapy unless the patient is eligible for cohort B2
Prior transurethral prostatic resection (TURP)
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.
No prior total prostatectomy or cryotherapy of the prostate\r\n* Prior transurethral resection or laser ablation is permitted
=< 3 months from a transurethral resection of the prostate (TURP) procedure
Patients should not have undergone previous transurethral resection of the prostate (TURP) within 1 year
No prior transurethral resection of prostate (TURP)
Any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix; patients with previous malignancies but without evidence of disease for > 3 years will be allowed to enter the trial; patients with a history of a T1a or b prostate cancer (detected incidentally at transurethral resection of the prostate [TURP] and comprising less than 5% of resected tissue) may participate if the prostate-specific antigen (PSA) remained within normal limits since TURP removal
Prior radical prostate surgery, transurethral resection of the prostate (TURP), or prostate cryotherapy
Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
Prior treatment for prostate cancer; this includes any prior surgery (including transurethral resection of the prostate [TURP]), chemotherapy, radiation, or anti-androgen therapy
Participants must have tumors with anticipated transurethral resection time =< 1 hour
Patients with tumors with anticipated transurethral resection time greater than 1 hour
Prior transurethral resection of the prostate (TURP)
Previous transurethral resection of the prostate (TURP)
Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding transurethral resection of the prostate [TURP]), radiation therapy, or chemotherapy
Patient that had TURP procedure before
Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields\r\n* Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score =< 15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive EBRT only
Has contraindications to cryotherapy of the prostate, including: previous transurethral prostatic resection (TURP) with persistent transurethral resection (TUR) defect, existing peri-anal or recto-urethral fistula, previous external beam radiation therapy or brachytherapy, coagulopathy, inability to tolerate anesthesia (spinal or general), inability to tolerate transrectal ultrasound (i.e. history of previous abdominal perineal resection)
Subjects who have undergone previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate
Prior prostate surgery (including transurethral resection of the prostate [TURP])
Prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator)
Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior transurethral prostatic resection [TURP] or greenlight photoselective vaporization of the prostate [PVP] which would be allowed)
a debulking transurethral resection of the prostate (TURP) is not acceptable once the screening biopsy for patient selection has been conducted;
Histologic documentation of prostatic adenocarcinoma; patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible; all eligible patients must have a known Gleason sum based on biopsy or transurethral resection of the prostate (TURP) at the time of registration
Prior transurethral resection of the prostate (TURP) procedure
Scheduled for prostate surgery, i.e. transurethral resection of the prostate (TURP) or prostatectomy
Prior history of transurethral resection of the prostate
Participants who are clearly disease-free after transurethral resection of bladder tumor (TURBT)
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy
Have had prior transurethral prostatectomy (TURP), or urethral stent,
Subjects who have had any surgical procedure (i.e. transurethral resection of the prostate [TURP], etc.) within 4 weeks prior to entering the study
Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
History of prior surgery for benign prostatic hyperplasia (e.g. transurethral resection of the prostate [TURP] or tissue ablation)
Subjects who have previously had a transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP), high intensity focused ultrasound (HIFU) or cryotherapy;
Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment; no limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed
No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
Previous prostate surgery for prostate carcinoma (including, transurethral resection of the prostate [TURP] and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, Bacillus Calmette-Guerin (BCG) for bladder cancer
Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
Prior transurethral resection of prostate
History of TURP (transurethral resection of prostate) or other similar procedures (transurethral microwave thermotherapy [TUMT], transurethral needle ablation [TUNA])
Patient has had surgery within 4 weeks prior to first dose
8. Major surgery within 4 weeks prior to first dose of TAB001 or still recovering from prior surgery;
Major surgery or radiation therapy within 4 weeks prior to the first study dose
Major surgery within 3 weeks prior to first dose
History or major surgery within 4 weeks before the first dose of study treatment, or not recovered from prior surgery
Major surgery within 3 weeks prior to first dose, prior peripheral stem cell transplant within 12 weeks of study enrollment
Major surgery within 4 weeks prior to the first study dose.
Major surgery within 4 weeks of the first dose of study treatment
Radiation therapy or major surgery within 4 weeks prior to first dose of study agent
No major surgery within 4 weeks of first dose of sEPHB4
History of major surgery within 4 weeks prior to first dose on this study
Major surgery within 4 weeks of first dose of investigational product
Major surgery within 3 weeks prior to first dose
Major surgery within 4 weeks prior to first study dose
Patients with major surgery or radiation therapy within 4 weeks prior to first study dose.
Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
Patient had major surgery within 4 weeks prior to the first dose.
Major surgery within 4 weeks prior to first dose of STA-9090
Major surgery or invasive intervention within 4 weeks prior to first dose
Subject has had major surgery within 4 weeks prior to the first study dose.
Major surgery within 4 weeks prior to first dose
Major surgery within 2 weeks prior to the first dose of lenvatinib.
Surgery within 4 weeks prior to first dose
Major surgery within 2 weeks of the first dose of study treatment
Subject has had major surgery within 4 weeks prior to the first study dose.
Major surgery within 4 weeks prior to first dose.
Subject has had major surgery within 4 weeks prior to the first study dose.
Major surgery within 3 weeks prior to first dose
Major surgery within 2 weeks of first dose of lenvatinib
Major surgery within 3 weeks prior to first dose
Major surgery within 3 weeks prior to first dose
Major surgery within 3 weeks prior to first dose
Surgery within 4 weeks prior to first dose
Major surgery within 4 weeks prior to first dose
Surgery within 4 weeks prior to first dose.
Major surgery within 3 weeks prior to first dose
Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
Major surgery or radiation within 4 weeks prior to 1st dose
Major surgery within 4 weeks prior to first dose
Subject has had major surgery within 4 weeks prior to the first study dose.
Major surgery within 4 weeks prior to first dose of ganetespib
Subject has had major surgery within 4 weeks prior to the first study dose.
Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI0680 (AMP-514) or still recovering from prior surgery
Major surgery within four weeks of the first dose of ARQ 092
Major surgery performed within 3 weeks prior to the first dose of study drugs or scheduled for major surgery during the study
Surgery within 4 weeks prior to first dose
Major surgery within 4 weeks prior to first dose of study treatment.
Subjects must not have had major surgery as determined by the PI within 4 weeks before the first dose of investigational agent.
No major surgery within 4 weeks of first dose of SGI-110.
History of major surgery within 4 weeks prior to first dose on this study
Scheduled for pancreaticoduodenectomy
Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
Scheduled surgery: open elective CRS-HIPEC.
Patients scheduled to receive intraoperative chemotherapy.
Scheduled radiation treatment using intensity-modulated pencil beam scanning (PBS) proton therapy
Patient must be scheduled to undergo treatment with WBRT to manage the brain metastases
Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound
Scheduled for major surgery after baseline;
Patients should have been identified by their respective physicians as candidates for radioembolization and scheduled to undergo such a procedure
The ability for the definitive cancer surgery to be scheduled within 10 days to 12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis – but from start of diet)
Patients who are scheduled to undergo therapeutic or prophylactic mastectomy with immediate placement of tissue expanders and have a strong family history or hereditary cancer
Scheduled to undergo radioembolization for treatment of intrahepatic metastases
Scheduled to undergo nephrectomy as part of treatment plan, per assessment through an MSK urologic surgeon listed as investigator on this trial
Scheduled to undergo either partial or radical nephrectomy as part of treatment plan
Subjects scheduled to undergo nipple sparing mastectomy
Patient must be scheduled for elective major cancer surgery at Fox Chase Cancer Center (FCCC) =< 30 days after first registration\r\n* Elective surgery is defined as:\r\n** Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery AND\r\n** Surgery is not scheduled as urgent or emergent
Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass
MAIN STUDY COHORT INCLUSION CRITERIA: Scheduled to undergo surgery with either partial or radical nephrectomy
Is scheduled for liver transplantation
Chemotherapy within 3 weeks of the first scheduled study treatment
Any patient with surgery scheduled < 7 days after biopsy
Patient is at least 21 days removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021.
Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
Surgical treatment or chemotherapy within three weeks of scheduled macrobead implantation or within four weeks of bevacizumab (or similar drugs), or radiation therapy within four weeks of scheduled macrobead implantation
Scheduled for intraoperative radiation of breast or chest wall
Part 1: have a diagnosis of metastatic melanoma and be scheduled to receive anti PD1 immunotherapy
Other cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors within 3 weeks prior to the first scheduled dosing.
Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
Scheduled for major surgery during the study.
No prior or scheduled Gliadel® wafer implant unless area of assessment and planned resection is outside the region previously implanted.
Are scheduled for debulking surgery during the study
Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI
Chemotherapy or radiation within 3 weeks of the first scheduled study treatment
Be scheduled for a colectomy procedure with a stapled anastomosis
Is scheduled to undergo a Hartmann's procedure
Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
Is scheduled to undergo procedure using omental wrapping
Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction
Scheduled for surgery during the study.
Scheduled for MLA
Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
Patients to be scheduled for a planned tumor debulking
Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed
Active infection within 14 days prior to scheduled treatment
Patients scheduled for extrapleural pneumonectomy
Scheduled for major surgery during the study.
Receipt of any investigational treatment within 4 weeks of scheduled dosing day 1.
Receipt of lapatinib within 7 days of scheduled dosing day 1.
Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.
Patients scheduled to have routine surgery during the study duration.
Patients must have received >= 2 daratumumab infusions and be scheduled to receive another dose
Removal of stent is scheduled to occur within six months
Scheduled for an open thoracotomy for lung resection
Patients are scheduled to undergo RARC at our institution
Patient is scheduled to undergo non-small cell lung cancer (NSCLC) resection: video assisted thoracoscopy (VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy; surgery must not be scheduled to take place < 3 weeks after registration
Patients scheduled for amputations as local control of their tumor
Not scheduled for any major surgery during the anticipated study period
Scheduled to receive or receiving unilateral radiation treatment for this cancer
Received an investigational therapy within the 4 weeks prior to registration, or is scheduled to receive one during the treatment period
BC patients scheduled to go on aromatase inhibitors after treatment\r\n* Note: at MSH only, there is another ongoing Breast Cancer R01 and in order to avoid conflicting with that protocol and overburdening patients, the study will exclude BC patients scheduled to go on aromatase inhibitors. We can easily reach recruitment goals with this approach)
PATIENT: Scheduled to undergo surgery
This study will be conducted in patients and family caregivers who are scheduled to undergo lung or GI cancer surgery treatment
Scheduled to begin, or within 18 months of beginning, treatment with an aromatase inhibitor at the time of the first study assessment (i.e., TP0)
PHASE 1 & 2: Identified at least two weeks prior to their scheduled surgery date
Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on or off-protocol
PATIENT: Cancer diagnosis should have been made within five years from the next scheduled appointment to the DCC
Phase I: Currently scheduled for autologous or allogeneic transplant at the Hospital of the University of Pennsylvania
PATIENTS: On scheduled chlorpromazine within the past 48 h
INCLUSION CRITERIA FOR PARENTS: Parents of children who are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
INCLUSION CRITERIA FOR PATIENTS: Child who are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
Scheduled surgery < 4 hrs
Scheduled surgery > 4 hrs
Scheduled for abdominal-based autologous breast reconstruction (deep inferior epigastric perforator [DIEP], muscle-sparing [MS]-transverse rectus abdominis [TRAM], or TRAM)
Patients scheduled for breast surgery
Patients scheduled for paravertebral block
Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period
Scheduled for major abdominal oncologic surgery
Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as Herceptin)
Scheduled for partial nephrectomy of renal mass
Patient is scheduled to receive adjuvant temozolomide at either 150 mg/m^2 or 200 mg/m^2 PO x 5 days out of a 28 day cycle +/- bevacizumab
Patients receiving scheduled benzodiazepines due to the risk of excessive sedation
Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer
Have not attended or scheduled an upcoming appointment for GC at the time of recruitment
This study will be conducted in people scheduled to undergo baseline LDCT as part of the City of Hope (COH) LCS program
Scheduled for major surgery within the study period
All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional >= 3 months
Be scheduled to start outpatient intravenous (IV) chemotherapy for reasons other than symptom palliation at Moffitt Cancer Center (MCC) or Sylvester Comprehensive Cancer Center (SCCC)
Be scheduled to receive chemotherapy on one of the five schedules
Patients scheduled for pancreaticoduodenectomy, central pancreatectomy or distal pancreatectomy
Scheduled to undergo an elective open or laparoscopic Whipple procedure
Patients scheduled for radiation less than 6 days from enrollment
Patients must not be scheduled to discontinue their TKI under medical supervision within the next 3 months
Scheduled for intended pancreatectomy, > 4 weeks until planned resection
Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization
Scheduled for elective radical cystectomy and urinary diversion for bladder cancer
Adult patients scheduled for thoracic surgery
On scheduled haloperidol of =< 8 mg in the last 24 hours
Scheduled to begin chemotherapy and/or radiation therapy within the next 2 months (excluding surgery only patients)
Scheduled for an open surgical procedure, which can be laparoscope-assisted
The scheduled procedure will be performed via midline laparotomy
Scheduled use of antiemetic agents other than ondansetron, granisetron, dexamethasone or aprepitant; patients may receive other antiemetic agents PRN for breakthrough nausea / vomiting but not on a scheduled basis
scheduled to begin chemotherapy or radiotherapy
Patients scheduled to undergo paclitaxel chemotherapy for breast cancer
scheduled to be discharged the same day of surgery
Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are scheduled to wear it
Patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
Scheduled to receive 14-day cycles of intravenous chemotherapy (e.g. doxorubicin and cyclophosphamide)
Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
Scheduled to be discharged the same day of surgery
Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
Scheduled to undergo abdominal surgery
Scheduled to receive epidural or intravenous patient controlled analgesia
Patients must be scheduled for, or have intent to schedule, a screening mammogram
Current routine mammogram has been/will be performed more than 8 weeks prior to scheduled screening ultrasound
Patients unable to complete their scheduled breast MRI
Women scheduled for screening CEDM alone
Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another
Patents must be scheduled for routine screening DBT
Scheduled to receive chemotherapy
Subjects scheduled to have > 3 Lumbar Punctures over the course of the study treatment period
Receiving or scheduled to receive first or second line chemotherapy (within 4 weeks)
Scheduled for a return clinic visit at one of the participating institutions
Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
Scheduled and eligible to receive at least one moderately or highly emetogenic chemotherapeutic agent on Day 1 only or for multiple days.
Scheduled to receive at least 3 consecutive cycles of THP or TCHP
Women scheduled for mastectomy or lumpectomy after DCIS or ADH diagnosis
Known inability to participate in the scheduled follow-up tests
Women who will be scheduled to undergo an RRSO or RRS
Must have or be scheduled to have a tunneled CVC
Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study
Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests
Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ? 200 mg/m2.
Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
Scheduled or planned percutaneous biopsy of at least one amenable lesion.
The patient has participated in another investigational drug study within 30 days of scheduled surgery
New diagnosis of lymphoma and scheduled to undergo doxorubicin hydrochloride (DOX)-based chemotherapy
Who are scheduled to undergo endoscopic or thoracic surgery surgery
Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Hennemeyer or one of his colleagues
HEALTHY CONTROLS: Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy
GYNECOLOGIC CANCER: Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy
Be scheduled for surgery to remove the adnexal mass
Scheduled to undergo radioimmunotherapy (RIT) for metastatic disease
Patient with suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients)
Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
Patient of Dr. Ranjna Sharma’s scheduled to undergo lumpectomy for breast cancer at Beth Israel Deaconess Medical (BIDMC)
Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
Already scheduled to undergo biopsy
PATIENT: Be scheduled for a surgical excision with SLN evaluation
PATIENT: Patients with a prior axillary procedure on the side scheduled for SLN evaluation
Scheduled to begin therapy
Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 gray (Gy)
Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent
Patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an MRI scan as part of their routine care
Patients scheduled to have a partial mastectomy or mastectomy for the treatment of breast cancer
Patient is scheduled to undergo a conventional bone scan
Patient is scheduled to undergo a conventional bone scan
Patients with known urologic cancer who are scheduled to undergo MRI with gadolinium for their routine care
Participant must be scheduled to undergo radioembolization for any indication
Patients must not have multicentric disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed are eligible
Scheduled to undergo primary debulking surgery
The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
Be scheduled for a biopsy (core/excisional/lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure
Patients scheduled for an EUS-FNA procedure of a pancreatic cyst
Surgical or core biopsy scheduled within 4 weeks of MRI/MRE
Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration
Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer
Patients who are scheduled to receive a 1.5T MRI exam
Subjects must be scheduled to undergo transarterial chemoembolization (TACE)
scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
Patients with Barrett’s esophagus scheduled for esophageal surgery
Patients with gastroesophageal reflux disease (GERD), but without Barrett’s esophagus scheduled for esophageal surgery
The subject has participated in another investigational drug study within 30 days of scheduled surgery.
Scheduled to receive radiation therapy
Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)
An upper GI endoscopy is scheduled to check upper abdominal symptoms.
Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to suspected pancreatic disorder.
Diagnosed with pancreatic cancer and scheduled to undergo surgery
Study Arm 1: primary diagnosis of a pelvic or adnexal mass of presumed gynecologic origin who is scheduled for operative resection
Stage I-IIIc disease:\r\n* Scheduled for lumpectomy or mastectomy\r\n* No prior or current therapy for breast cancer\r\n* Not considered candidate for therapeutic neoadjuvant treatment
Be scheduled to receive at least 6 weeks (i.e. at least 2 cycles) of oral or intravenous (IV) chemotherapy during the study intervention period; therapeutic clinical trial participants are allowed
Patients scheduled to receive first allogeneic BMT
Scheduled to undergo surgery that will result in the creation of an ileostomy
Exclude patients who have a FOBT or colonoscopy scheduled within the last six months
Patients of study surgeons who are scheduled to have a surgical procedure identified by study surgeons to the study team
Scheduled for a surgical consult with breast surgeon
Scheduled for a lumpectomy for a breast malignancy.
Who are scheduled to undergo laparotomy for the debulking surgery OR
Scheduled for a lumpectomy of a breast tumor.
Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ?3 months.
Who are scheduled to undergo laparotomy for the debulking surgery OR
Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
Scheduled for endoscopic screening and/or evaluation of Barrett’s esophagus
Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start
Patients must have completed any major surgery or open biopsy >= 4 weeks from start of treatment
Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
Major surgery within 4 weeks of study treatment start
Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy); or use of any investigational drug within 28 days before the start of trial treatment.
Major surgery within 3 weeks prior to the start of study treatment
Major surgery within 4 weeks before the start of study therapy.
Major surgery within 4 weeks before the start of study therapy.
Major surgery as determined by the investigator within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted).
Major surgery as determined by the investigator within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted).
Major surgery within 4 weeks before the start of study therapy.
Major surgery within 4 weeks before the start of study therapy.
Recent major surgery (within 6 weeks prior to the start of study treatment) other than for diagnosis
At least 3 weeks between major surgery and planned start of study treatment; major incisions must have healed
Subjects must start study agent within 6 weeks from the first diagnostic surgery for glioblastoma
No major surgery within 14 days of start of study treatment
Major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis
Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Recent major surgery (within 6 weeks prior to the start of study treatment) other than for diagnosis
Major surgery within 30 days prior to the start of study medication.
Major surgery within 30 days prior to start of treatment
Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment
Major surgery within 14 days prior to start of study treatment
Major surgery (within 4 weeks prior to the start of cycle 1), except for procedures that are performed for diagnostic purposes
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Major surgery within 2 weeks of the start of study treatment, or ongoing complications from surgeries performed previously
A minimum of 4 weeks from any major surgery prior to start of study drug
Patients must not have any major surgery or radiation therapy within 14 days of start of study treatment
Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
Major surgery within 14 days prior to start of study treatment
Subjects who have had a major surgery or significant trauma within 4 weeks before the start of study treatment
Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment
Major surgery less than 1 month before start of the study
Major surgery less than 1 month before the start of the study
Had a major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine
Major surgery performed < 28 days from treatment start
Major surgery within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted)
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Major surgery within 4 weeks of the start of study treatment, without complete recovery
Major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis
Major surgery within 30 days prior to start of study drug
Major surgery (within 4 weeks prior to the start of cycle 1), except for procedures that are performed for diagnostic purposes
Major surgery within 30 days prior to start of study drug
Prior major surgery less than 4 weeks prior to the start of the study;
A minimum of 4 weeks from any major surgery prior to start of study drug
Major surgery within 30 days prior to start of study drug
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Major surgery < 4 weeks from the start of treatment
Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines, monoclonal antibodies or major surgery in the 4 weeks prior to the start of the study
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
Major surgery within 4 weeks before the start of study therapy.
Major surgery within 4 weeks before the start of study therapy;
Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
Major surgery within 4 weeks of the start of study treatment, without complete recovery
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Less than 3 weeks between major surgery and planned start of study treatment; major incisions must have healed
Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Major surgery within 4 weeks before start of study treatment, without complete recovery
Major surgery within 4 weeks of the start of study treatment, without complete recovery
Major injuries and/or surgery within the past ten days prior to start of study drug
Major surgery within 4 weeks prior to the start of the study;
Major surgery or radiation therapy within 4 weeks from start of treatment
Major surgery less than 4 weeks before the start of the study
Major surgery within 14 days prior to start of study treatment
Major surgery within 4 weeks of the start of study treatment, without complete recovery
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP; Note: local surgery of isolated lesions for palliative intent is acceptable
Patients must not have had standard of care chemotherapy, radiotherapy, or major surgery within the last 2 weeks prior to entering the study; Note: local surgeries for isolated lesions for palliative intent are acceptable; for recent experimental therapies a 28 day period of time must have elapsed before commencing protocol treatment
EXCLUSION - DURVALUMAB DRUG-SPECIFIC: Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of durvalumab. \r\n* Note: Local surgery of isolated lesions for palliative intent is acceptable per investigator discretion.
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. \r\n* Note: Local surgery of isolated lesions for palliative intent is acceptable.
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of ipilimumab, (IP). \r\n* Note: Local surgery of isolated lesions for palliative intent is acceptable.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study medication. Note: Local surgery of isolated lesions for palliative intent is acceptable.
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of durvalumab or tremelimumab. Note: Local surgery of isolated lesions for palliative intent is acceptable.
Major surgical procedure within 28 days prior to the first dose of durvalumab; local surgery of isolated lesions for palliative intent is acceptable
Major surgery (as defined by the investigator) within 4 weeks or thoracotomy for pulmonary metastases within 2 weeks prior to first dose of treatment or if still recovering from prior surgery; local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure within 28 days prior to the first dose of IP; Note: local surgery of isolated lesions for palliative intent is acceptable
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; NOTE: local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., by local ablation, surgery or radiotherapy)
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of immunotherapy; Note: Local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of investigational product (IP); Note: Local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure, as defined by the investigator, within 28 days prior to the first dose of IP; Note: local surgery or isolated lesions for palliative intent is acceptable
Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI6383 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure (as defined by the local/lead site PI) within 28 days prior to the first dose of investigational product (IP); Note: local surgery of isolated lesions for palliative intent is acceptable