--- a +++ b/clusters/9knumclustersv2/clust_1119.txt @@ -0,0 +1,215 @@ +Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =< days prior to registration is required +Women of childbearing potential must have a negative serum pregnancy test within days prior to study entry +Serum or urine pregnancy test must be negative in premenopausal women within days of randomization, or in women with amenorrhea of less than months at time of randomization. +Pregnant women, or women of childbearing potential without a negative pregnancy test within days prior to randomization. +Pregnant or lactating women; a negative pregnancy test in women of childbearing potential must be documented within days before the first dose of study medication +Negative pregnancy test for women of childbearing potential (< years of age) as per institutional policy +Negative serum pregnancy test in women of childbearing potential (WOCBP) +A negative pregnancy test =< days prior to treatment for premenopausal women and for women < year after the onset of menopause +Negative serum pregnancy test within days prior to study treatment in premenopausal women and women less than (<) months after menopause +Negative serum/urine pregnancy test (for women of childbearing potential) +Positive pregnancy test; Note: Pregnant women are excluded from this study; breastfeeding should be discontinued; negative serum pregnancy test will be required for women of childbearing potential +Negative pregnancy test by urine or serum or waiver of pregnancy testing per local institutional policy within days prior to randomization according to local standards for women of childbearing potential +Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the -hour period prior to the first dose of study drug. +Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy +Negative serum pregnancy test within days prior to study treatment in premenopausal women and women <= years after menopause +Women of childbearing potential must have a negative urine or serum pregnancy test within days prior to the start of the study +Women of childbearing potential (WOCBP) must have negative urine pregnancy test within days of day (D) of treatment +Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study +Negative serum pregnancy test within days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within hours prior to administration of SRS +Pregnant or lactating, or intending to become pregnant during the study\r\n* Women of childbearing potential must have a negative serum pregnancy test result within days prior to initiation of study drug +Negative serum pregnancy test within days of commencement of treatment in women of childbearing potential +Women of childbearing potential must have a negative serum or urine pregnancy test within - days prior to enrollment +Women of childbearing potential must have a negative serum or urine pregnancy test. +Non pregnant and non-nursing women; women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient to be eligible for trial enrolment +Women of childbearing potential must have negative pregnancy test prior to initiating study treatment. +Women of childbearing potential must have a negative serum or urine pregnancy test within day prior to administration of the first dose of chemotherapy +Women of childbearing potential must have a negative serum or urine pregnancy test at time of screening and confirmed within days prior to treatment; women not of child-bearing potential will be defined as all women older than age and anovulatory for months +Negative serum pregnancy test within days prior to cycle /day for women of childbearing potential +Urine pregnancy test is negative for women of childbearing potential, within days before study treatment +Negative pregnancy test and willingness to utilize contraception among women of childbearing potential +A negative urine pregnancy test is required within week for all women of childbearing potential prior to enrolling on this trial +DONOR: Women of childbearing potential (WOCBP): Urine pregnancy testing performed within days prior to stem cell mobilization +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to treatment; women not of child-bearing potential will be defined as all women older than age and anovulatory for months +Women of childbearing potential must have a negative urine or blood pregnancy test within days of study enrollment +Negative serum pregnancy test within =< days prior to the first dose of study drug, for women of childbearing potential only +Pregnant or breast-feeding patients; women of childbearing potential (WOCBP) must have a serum pregnancy test performed a maximum of days before the start of study treatment, and a negative result must be documented before the start of study treatment +Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within days prior to randomization, irrespective of the method of contraception used, are excluded from this study; breastfeeding must be discontinued prior to study entry +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to registration; women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries; all others are considered women of child bearing potential +Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient to be eligible for trial enrollment +Negative urine or serum pregnancy test for women of childbearing potential +Pregnant or breast feeding women are excluded from participating in this study; WOCBP must have a negative serum pregnancy test within days of the first administration of decitabine +Women of childbearing potential must have a negative pregnancy test within days of starting treatment +A negative pregnancy test (only for women of childbearing potential [WOCBP]) +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Women of childbearing potential must have a negative urine or serum pregnancy test within days of study entry +Women of childbearing age must have a negative serum pregnancy test to meet eligibility per Duke policy +PHASE I: Negative urine pregnancy test =< days prior to course day (CD) (women of childbearing potential only) +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to treatment +Women of childbearing potential must have a negative qualitative serum pregnancy test =< weeks prior to study entry +Negative urine or serum pregnancy test done =< days prior to computed tomography (CT) simulation, for women of childbearing potential only +Negative serum pregnancy test within days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Pregnant and breastfeeding women will be excluded; women of childbearing potential must have a negative pregnancy test within days of initiation of treatment +Women of childbearing potential must have a negative serum or urine pregnancy test within days of treatment. +Negative urine or blood pregnancy test for women of childbearing potential +Negative pregnancy test within days prior to commencement of dosing in premenopausal women, women of non childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Pregnant or breast-feeding patients; women of childbearing potential must have a pregnancy test performed a maximum of days before start of treatment, and a negative result must be documented before start of treatment +Negative serum pregnancy test within days prior to commencement of dosing in women of childbearing potential +Women of childbearing potential must have a negative serum pregnancy test within days prior to initiation of treatment. +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Pregnant or lactating - women of childbearing potential should use appropriate precautions to avoid becoming pregnant; females of childbearing potential must have a negative urine or serum pregnancy test within days of study treatment start +Women of childbearing potential must have a negative serum or urine pregnancy test within days; women of childbearing potential and men must agree to use contraception at study entry and for the duration of active study treatment +A negative urine pregnancy test is required within week for all women of childbearing potential prior to enrolling on this trial +Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment. +Negative pregnancy test in women of childbearing age +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +For women of childbearing age, a negative pregnancy test performed within days of surgery +Women of childbearing potential must have a negative serum or urine pregnancy test performed within days prior to FDG-PET-MRI +A negative urine pregnancy test is required within week for all women of childbearing potential prior to enrolling on this trial +Women of childbearing potential must have a negative serum pregnancy test within days prior to study entry +Women of childbearing potential must have a negative serum or urine pregnancy test within weeks prior to initiation of therapy +A negative urine pregnancy test is required within week for all women of childbearing potential prior to enrolling on this trial +Negative pregnancy test (urine or serum), within day prior to day of FOLFIRI in women of childbearing potential +For women of childbearing potential, negative urine or serum pregnancy test within weeks prior to study entry +Women of childbearing potential who are not using an effective method of contraception are excluded; women of childbearing potential must have a negative urine or serum pregnancy test within hours prior to administration of SRS +Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy +Negative serum pregnancy test result within days prior to study drug among women of childbearing potential +Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within days prior to study initiation. +Women of childbearing potential must have a negative pregnancy test within days of starting treatment +Childbearing age women with negative pregnancy test +Women of childbearing potential who have a negative pregnancy test within days of the first dose of sorafenib in this long term extension program. +Pregnant women or women of childbearing potential and not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential; no breast-feeding while on study. +. Women must not be pregnant or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to start of study drug administration. +Pregnant or breastfeeding - The agents used in this study fall under Pregnancy Category D - Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. Women of childbearing potential must have a negative pregnancy test (urine or serum) within days of study drug administration +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to initiation of treatment AND confirmed prior to initiation of treatment on day +A negative urine pregnancy test is required within week for all women of childbearing potential prior to enrolling on this trial +Pregnant or lactating women; pregnant women are excluded from this study; women of childbearing potential must have a negative pregnancy test per standard of care prior to the surgery for tumor removal; a second pregnancy test must be performed days prior to the first vaccination and must be negative; breastfeeding should be discontinued if the mother is treated on study +Negative urine or serum pregnancy test for women of childbearing potential within days prior to study entry +Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within days prior to initiation of study drug +Negative pregnancy test (either urine or serum) within days prior to randomization for all women of childbearing potential (above) +Negative serum pregnancy test within days of treatment initiation with ibrutinib in women of childbearing potential (WOCBP) +Pregnant women are excluded from this study; women of childbearing potential must have a negative pregnancy test +Evidence of non-child-bearing status for women of childbearing potential; negative urine or serum pregnancy test within days of study treatment, confirmed prior to treatment on day +Women of childbearing potential must have a negative serum or urine pregnancy test within days of the administration of the first study treatment; women must not be lactating +Women of childbearing potential must have a negative pregnancy test performed within days prior to the start of study drug +Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days prior to start of study treatment +Women of childbearing potential must have a negative serum pregnancy test within days of the first dose of study treatment +Women of childbearing potential (defined as having a menstrual cycle within the past months and not having had a surgical procedure to accomplish sterilization) must have a negative serum pregnancy test within seven days of screening +Women of childbearing potential (defined as having a menstrual cycle within the past months and not having had a surgical procedure to accomplish sterilization) must have a negative serum pregnancy test within seven days of starting the vemurafenib +For women of childbearing potential, a negative serum or urine pregnancy test +Negative serum pregnancy test in women of childbearing potential within weeks of study +Premenopausal women must have a negative serum pregnancy test, including women who have had a tubal ligation and for women less than months after the onset of menopause +Women of childbearing potential must have a negative serum pregnancy test within days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study. +Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test within days of day (D) of treatment +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Negative pregnancy test and willingness to utilize contraception among women of childbearing potential +Women of childbearing age with a negative pregnancy test documented prior to enrollment +Patients with a negative pregnancy test (urine or serum) must be documented within days of starting treatment for women of childbearing potential (WOCBP) +Women of childbearing age with a negative pregnancy serum test documented prior to enrollment +A urine pregnancy test (within days of enrollment date) is required for women with childbearing potential +Negative pregnancy test for women of childbearing potential (< years of age) as per institutional policy +Postmenopausal or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within days prior to start of IPs +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to receiving study agents +Negative urine or serum pregnancy test done =< days prior to registration/randomization, for women of childbearing potential only\r\n* NOTE: in the rare case that a woman enrolling on study is of childbearing potential, a pregnancy test is required prior to enrollment on study +Women of childbearing potential must have a negative pregnancy test performed within days of the start of study drug administration +Negative pregnancy test within days prior to starting the study premenopausal women; women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Women of childbearing potential (WOCBP) must have negative pregnancy test within days prior to day (D) of treatment +If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within days of surgical treatment on study +A positive serum pregnancy test within days prior to treatment in women of childbearing potential +Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least months) or if of childbearing potential, must have a negative serum pregnancy test within days before the start of the treatment; women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test; if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol; women of childbearing potential must agree to use an adequate method of contraception during the study until days after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until days after the last treatment +Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than months after the onset of menopause +Women of childbearing potential must have a negative serum/urine pregnancy test +Women of childbearing potential (WOCBP) must have a negative pregnancy test within days of receiving study medication +Negative serum pregnancy test within days of commencement of treatment in premenopausal women +Women of childbearing potential must have a negative pregnancy test within days of starting treatment +Pregnancy or breast feeding - women of childbearing potential must have a negative pregnancy test within days of study enrollment +Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment. +Women of childbearing potential with negative serum pregnancy test prior to randomisation +Women of childbearing potential must have a negative, qualitative serum pregnancy test =< weeks prior to study entry +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of pazopanib treatment and both men and women must be willing to use adequate contraception +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to treatment +Pregnant or breastfeeding patients; women of childbearing potential must have a pregnancy test performed a maximum of days before start of FOLFIRI treatment, and a negative result must be documented before start of treatment +Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment +Women of childbearing age must have a negative serum or urine pregnancy test prior to the initiation of study drug. +Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry +Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy +Serum or urine pregnancy test (for women of childbearing potential) negative =< days of starting treatment +Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within days of study treatment and confirmed prior to treatment on Day ; +Women of childbearing potential must have a negative pregnancy test performed within weeks prior to the start of treatment +Women of childbearing age must have a negative serum pregnancy test, and adequate contraception method(s) must be documented +Negative pregnancy test in women of childbearing potential (premenopausal or less than months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than days before the first dose of study treatment +Women of childbearing potential (WOCBP) must have negative pregnancy test within days prior to day (D) of treatment +Pregnant or breastfeeding; a negative blood-pregnancy test is required for women of childbearing potential (WOCBP) within days prior to her computed tomography (CT) stimulation for treatment planning +Women of childbearing potential must have a negative serum pregnancy +Negative urine pregnancy test within days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without urine pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Women of childbearing potential must have a negative pregnancy test performed within days prior to the start of treatment +Negative serum or urine pregnancy test within days prior to study treatment in premenopausal women and women </= years after menopause (menopause is defined as amenorrhea for >/= years) +For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy +Negative pregnancy test for women of childbearing potential within days of starting study treatment +Pregnant or breast-feeding women; women of childbearing potential must have a negative urine or serum pregnancy test within days of start of treatment +Negative urine pregnancy test for women of childbearing potential +Adequate bone marrow function Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within days prior to study initiation. +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Women of childbearing potential must have a negative serum pregnancy test within days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least days after the last administration of pralatrexate. +For women of childbearing potential, have a negative pregnancy test (serum or urine) on Day prior to initiating study treatment. +Serum or urine pregnancy test negative within weeks for women of childbearing potential +Women of childbearing potential must have a negative pregnancy test (urine or serum) performed within days prior to the start of study drug. +Negative pregnancy test (urine dipstick or serum) for women of childbearing potential within weeks prior to registration +Negative serum or urine pregnancy test must be obtained within days before the first dose of study drug in women of childbearing potential. Negative results must be available before study drug administration +Women of childbearing potential must have a serum pregnancy test performed within days prior to the first day of study drug dosing. +Women of childbearing age must have a negative urine pregnancy test +Women of childbearing potential (WOCBP) must have a negative pregnancy test performed prior to the start of study drug +Negative serum pregnancy test within days prior to starting study treatment in premenopausal women and women less than (< ) years after the onset of menopause +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to the start of SL- treatment. +Women of childbearing potential must have a negative serum pregnancy test within days of first dose of study treatment. +Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of days before start of study treatment, and a negative result must be documented before start of study treatment +Women of childbearing potential (WOCBP) who have a positive serum pregnancy test within days of the first administration of oral dasatinib +Women of childbearing potential must have a negative urine pregnancy test performed within days before start of study treatment +Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < months after entering menopause +Women of childbearing potential must have a negative urine or serum pregnancy test within days prior to administration of everolimus +Women of childbearing potential must have a negative serum pregnancy test before study entry. +Negative serum or urine pregnancy test for women of childbearing potential only +Negative serum pregnancy test within days before starting study treatment in women with childbearing potential +Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment +Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to treatment +Pregnant or nursing women; a negative pregnancy test (serum or urine) =< days prior to starting study treatment +Women of childbearing potential must have a negative pregnancy test performed within days prior to the start of study drug +Negative serum pregnancy test within days prior to commencement of dosing in women of childbearing potential +Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< days prior to registration and confirmation they are not nursing is required +Premenopausal women (including women who have had a tubal ligation and for women less than months after the onset of menopause) must have a negative serum pregnancy test +Non-pregnant; women of childbearing potential must have a negative pregnancy test to participate in this study +If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within days of surgical treatment on study +Negative pregnancy test (serum or urine) done =< days prior to registration, for women of childbearing potential only (determined per clinician discretion) +Women of childbearing potential must have a negative serum pregnancy test within days prior to initiation of treatment. +Negative (serum or urine) pregnancy test, for women of childbearing potential only +Negative serum pregnancy test within days prior to study treatment in premenopausal women and women less than or equal to (<=) months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) months. +Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test +Women of childbearing potential (WCBP) must have a negative urine pregnancy test within days prior to the first study intervention +Negative pregnancy test at time of signing consent for women of childbearing potential +Women of childbearing potential must have a negative urine or serum pregnancy test +Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women who are >= years old or who have had a hysterectomy, both ovaries removed, or a tubal ligation will not be required to have a pregnancy test +Women of childbearing age with a negative pregnancy test documented prior to enrollment +A negative serum pregnancy test at baseline, but within days of randomization, for persons of childbearing potential only +Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =< days prior to registration/randomization for women of childbearing potential +A negative serum pregnancy test within days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ? year or who have a history of hysterectomy or surgical sterilization) +Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test or who are lactating +Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within days prior to PET scan +Negative pregnancy test within days prior to starting the study in premenopausal women; women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for >= year +Patients of childbearing potential must have a negative urine or serum pregnancy test within days prior to PET/CT imaging per institutions standard of care. +Pregnant and/or breastfeeding; women of childbearing potential must have a negative urine or serum pregnancy test no more than days prior to FDOPA injection +Women of childbearing age must have a negative blood pregnancy test +Women of childbearing potential must have a negative serum or urine pregnancy test performed within days prior to first PET/MRI +Women must have a negative serum pregnancy test within days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal +Women of childbearing potential must have a negative serum or urine pregnancy test within days prior to enrollment. +Pregnant or breastfeeding (negative serum or urine pregnancy test required for women of childbearing potential), or unable to maintain use of contraception while on study and for days after the last dose of avelumab +Women of childbearing potential will be required to have a urine pregnancy test +Women of childbearing potential must have a negative pregnancy test prior to the administration of protocol specified interventions +Negative urine pregnancy test for women of childbearing potential within days of baseline [D]phe dosing +Negative serum pregnancy test within days prior to study treatment in premenopausal women and women <= years after start of menopause +Pregnant or lactating women; all pre-menopausal women being screened must have a negative serum pregnancy test within days prior to commencement of dosing; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= year +Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge +For women of childbearing potential, negative serum pregnancy test within days of enrollment +Negative serum or urine pregnancy test must be obtained within days prior to the first dose of study drug in women of childbearing potential. Negative results must be available prior to study drug administration. Pregnancy tests will be repeated regularly during treatment