[c09aa8]: / clusters / 9knumclustersv2 / clust_2927.txt

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Woman of non-child bearing potential due to surgical sterilization (at least weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (i.e., no menstrual bleeding for more than months in a women aged years or more), OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least acceptable methods of birth control, one of which must be highly effective, during the study and for at least days after stopping TRC or pazopanib
Females of child-bearing potential cannot be pregnant or breast-feeding; female participants > years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment
Negative serum pregnancy test obtained for females of child-bearing potential within days prior to step registration
For females of child-bearing potential, negative serum or urine pregnancy test within days prior to study registration
Woman of non-child bearing potential due to surgical sterilization confirmed by medical history or menopause, OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least forms of a reliable and highly effective method of birth control during the study and for at least days after stopping TRC or sorafenib.
Females should be using adequate contraceptive measures, not be breast feeding and must have negative pregnancy test prior to start of dosing if of child-bearing potential
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test; both male and female patients of reproductive potential must agree to use a reliable method of birth control, during the study and for months following the last dose of study drug
Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to start of treatment. Participants must agree to ongoing pregnancy testing. All patients must be willing to comply with all requirements of the USA pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program or the pomalidomide Pregnancy Prevention Plan (PPP).
Women of child-bearing potential must have a negative pregnancy test (urine or serum) within days prior to starting the study drug; both males and females must agree to adequate birth control if conception is possible during the study and for months after the last dose; female patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of year without menses
Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four () months after receiving the preparative regimen; females of child-bearing potential must have a negative pregnancy test
Females of child bearing potential and males must agree to use barrier method/hormonal methods from start of study until four months after last dose of study drug; females of child bearing potential must have a negative serum pregnancy test at screening; females are not considered to be of child bearing potential if they are status post successful surgical sterilization including hysterectomy, bilateral tubal ligation or bilateral oophorectomy, or if they are postmenopausal (absence of menses for consecutive months that is not secondary to prior chemotherapy, anti-estrogens, ovarian suppression or other reversible cause)\r\n* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from weeks prior to the study and until month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within days prior to the start of study treatment
Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding at the time of screening, during the study and until months after completion of study, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling of the following criteria at screening:
Females should be using adequate contraceptive measures from the time of screening until months after study discontinuation, should not be breast feeding and must have negative pregnancy test prior to the start of dosing.
Women of child-bearing age must obtain a pregnancy test and pregnant or breast-feeding females are excluded
AUTOLOGOUS APHERESIS: For females of child bearing age:\r\n* Not lactating with intent to breastfeed\r\n* Not pregnant with negative serum pregnancy test within days prior to enrollment
TREATMENT WITH SJCAR: For females of child bearing age:\r\n* Not lactating with intent to breastfeed\r\n* Not pregnant with negative serum pregnancy test within days prior to enrollment\r\n* If sexually active, agreement to use birth control until months after T-cell infusion; male partners should use a condom
Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing
Females of child bearing potential must have a negative serum pregnancy test with days prior to first dose of treatment and use methods of contraceptives while on treatment
Females should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding
Subjects of child bearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study and for four () months after receiving the preparative regimen; females of child bearing potential must have a negative pregnancy test
For females of child-bearing age, a negative pregnancy test.
Negative urine or serum pregnancy test result for females of child bearing potential; females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than % per year for the duration of study participation and for a period of weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that females of child-bearing potential use contraception for half-lives plus days and males who are the sexual partners of females of child-bearing potential use contraception for half-lives plus days; \r\n* Females must not be breast-feeding\r\n* Females of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within hours prior to the start of nivolumab\r\n* A female of child-bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.; menopause is defined clinically as months of amenorrhea in a female over in the absence of other biological or physiological causes; in addition, females under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Females must be using adequate contraceptive measures, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
Have a negative serum beta human chorionic gonadotropin (?-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for days afterward the last dose of study treatment.
Females of child bearing potential must have a negative serum pregnancy test within days prior to entrectinib dosing
Females of child-bearing potential willing to use adequate contraceptive measures from the time of screening until months after trial discontinuation, who are not or will not be breast feeding, and agree to have pregnancy tests prior to the start of dosing and at regular visits during the trial. Females not of childbearing potential must have evidence of such by fulfilling one of the following criteria at screening:
Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is >= years of age and has not had menses for greater than year]) must test negative for pregnancy within hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for days following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within hours of receiving study drug administration; if appropriate; contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within hours prior to the study drug administration
Females of child-bearing potential must have a negative pregnancy test within days prior to registration; patients with reproductive potential must agree to use an effective contraceptive method during treatment
Females of child-bearing potential must have a negative serum pregnancy test within days of treatment.
Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential)
Woman of non-child bearing potential due to surgical sterilization (at least weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause, OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least forms of a reliable and highly effective method of birth control during the study and for at least days after stopping TRC, bevacizumab, paclitaxel, and/or carboplatin
Pregnant or lactating female: all females of child-bearing potential must have a negative serum pregnancy test within days of treatment; lactating females must discontinue breast feeding
For females of child-bearing potential, negative serum pregnancy test at screening (within hours prior to leukapheresis)
Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment
Pregnancy test (serum or urine): negative for females of childbearing potential: a female is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
Females of child-bearing potential must have a negative pregnancy test within days prior to registration
Females of child-bearing potential must have negative serum pregnancy test within hours before randomization.
Pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
Negative urine or serum pregnancy test for females of child bearing potential within days prior to registration\r\n* Females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than % per year for the duration of study participation and for a period of weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that females of child-bearing potential use contraception for half-lives plus days and males who are the sexual partners of females of child-bearing potential use contraception for half-lives plus days\r\n* Females must not be breast-feeding\r\n* Females of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab\r\n* A female of child-bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as months of amenorrhea in a female over in the absence of other biological or physiological causes; in addition, females under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Women who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test within days prior to the start of study treatment.
The subject must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for days afterward if treated with foscarnet.
Females of child-bearing potential* must have a negative pregnancy test.
Negative urine or serum pregnancy test done =< days prior to registration for females of child bearing potential only
Negative serum pregnancy test result for females of child bearing potential
Pregnant females are excluded from this study; all females of child-bearing potential will undergo a serum pregnancy test within hours prior to FBnTP administration
Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through months after the last dose of treatment
Pregnant women are excluded from this study; females of child bearing potential must have a negative pregnancy test within days of study treatment; breastfeeding must be discontinued before beginning fludarabine (fludarabine phosphate)
For females of child-bearing potential, negative serum pregnancy test within days prior to registration
Females of child-bearing potential must have a negative pregnancy test
Negative serum or urine pregnancy test for females of child bearing potential
Females with child-bearing potential must have had a negative serum pregnancy test result =< days prior to the first dose of study treatment
Women should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test before start of dosing if of child-bearing potential or must have evidence of nonchildbearing potential.
Females will be either postmenopausal for at least year or surgically sterile for at least months; OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy from screening until months after their last dose of study medication
Females should agree to use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
For females of child-bearing potential, negative serum/urine pregnancy test within days prior to study registration
Negative pregnancy test for all females of child bearing potential
Females of child-bearing potential using contraception; negative pregnancy test
Females of child-bearing potential must have a negative serum pregnancy test within days prior to randomization.
Females will be either postmenopausal for at least year or surgically sterile for at least months OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through months after the last dose of treatment
Females of child-bearing potential (not surgically sterilized and between menarche and year post menopause) must test negative for pregnancy within hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for months following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within hours of receiving study drug administration; if appropriate contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within hours prior to the study drug administration
Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.
For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for months after the treatment period
Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug
Females with child bearing potential must have a negative serum pregnancy test within days of the first dose of study drug
Females who are pregnant or lactating may not participate in this study; females of child-bearing potential must have a negative pregnancy test before starting study agent; patients who have had a bilateral oophorectomy, hysterectomy, or are greater than year since their last menses are not considered to be of child-bearing potential
Females of child-bearing potential must have a negative serum test Participation in concurrent clinical trials
Females must be either non-child bearing potential or have a negative pregnancy test within to days prior to the first dose of study drug.
Females of child bearing potential (defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy, or are not naturally postmenopausal ? consecutive months) must have negative urine or blood pregnancy test prior to enrollment and use adequate birth control methods (abstinence, oral contraceptives, barrier method with spermicide, or surgical sterilization) during study participation. Males must agree to use a latex condom during any sexual contact with females of child bearing potential while participating in the study and for weeks following the last dose of dalantercept, even if he has undergone a successful vasectomy. Patients must be counseled concerning measures to be used to prevent pregnancy and potential toxicities prior to the first dose of dalantercept.
Females of child-bearing potential must be willing to practice acceptable methods of birth control. Additionally, females of childbearing potential must have a negative serum pregnancy test within days prior to start of study drugs, throughout treatment period and for months after last dose of study drugs.
Females of child-bearing potential (with negative serum pregnancy test within days prior to the first dose of study medication) must be willing to practice acceptable methods of birth control .
Females must either be of non-child bearing potential or have a negative serum pregnancy test within days prior to the first dose of study treatment.
Pregnancy or lactation; all females of child-bearing potential must have negative serum or urine pregnancy tests within days prior to starting study treatment
of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to use protocol specified methods of birth control while on study.
Pregnant or breast feeding females (a urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy)
Females of child-bearing potential (FCBP)^:
Pregnancy test for females of child-bearing potential
Negative serum/urine pregnancy test within hours for females of child bearing age prior to surgery
Females of childbearing potential must not be pregnant or breastfeeding on admission for conditioning for SCT and a pregnancy test will be required for all females of child-bearing potential
Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within days before starting drug
Females of child bearing age must have a negative serum pregnancy test within days of first dose of study drug
Females of child-bearing potential must have a negative pregnancy test within the current menstrual cycle and within days before starting drug
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit
Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential
Negative serum pregnancy test for females of childbearing age (- years) and/or lack child-bearing potential
Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nNegative serum or urine pregnancy test within hours for females of child bearing age
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nNegative serum or urine pregnancy test within hours for females of child bearing age
Negative serum pregnancy test for females of child-bearing age (- years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy)
BIODISTRIBUTION COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening
DYNAMIC COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening