--- a +++ b/clusters/unpackedclusters/clust_74.txt @@ -0,0 +1 @@ +Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtainedXx_NEWLINE_xXPregnant female patients are not eligible for this studyXx_NEWLINE_xXFemales of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug* Childbearing potential is defined as girls who are > Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy* Urine pregnancy tests are acceptableXx_NEWLINE_xXFemale patients who are pregnant are ineligibleXx_NEWLINE_xXFemale patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtainedXx_NEWLINE_xXMen and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study; female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this studyXx_NEWLINE_xXFemale patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy testXx_NEWLINE_xXFemale participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized womenXx_NEWLINE_xXKnown pregnancy or breast feeding; pregnant women are excluded as the effects of 18F-FLT on the fetus are not known, and there is the potential for teratogenic or abortifacent effects; within 48 hours prior to a PET scan, a pregnancy test will be obtained in all female participants of child bearing potential to confirm non-pregnant status; because there is an unknown, but potential, risk of adverse effects in nursing infants, breastfeeding should be discontinued before the mother receives 18F-FLTXx_NEWLINE_xXPregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)Xx_NEWLINE_xXFemale subjects of childbearing potential must not be pregnant or breast-feeding; female subjects of childbearing potential must have a negative serum or urine pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of therapy)Xx_NEWLINE_xXFemale patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchalXx_NEWLINE_xXThe study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)Xx_NEWLINE_xXWomen of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)Xx_NEWLINE_xXPatients who are pregnant; pregnancy test is required for female patients of childbearing potentialXx_NEWLINE_xXFemale patients of childbearing potential must have a negative serum pregnancy test at the time of enrollmentXx_NEWLINE_xXPatients who are pregnant; a pregnancy test is required for female patients of childbearing potentialXx_NEWLINE_xXPatients who are pregnant; (a negative pregnancy test is required for female patients of childbearing potential)Xx_NEWLINE_xXFemale subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasonsXx_NEWLINE_xXFemale patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potentialXx_NEWLINE_xXFemale subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)Xx_NEWLINE_xXINCLUSION CRITERIA FOR STRATUM C: Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)Xx_NEWLINE_xXPregnancy or breast-feeding � female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment; women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method; female patients should not become pregnant while participating in this research study or for 90 days following therapy; male patients should not father a child while in this research study or for 90 days following therapyXx_NEWLINE_xXFemale patients who are pregnant are ineligibleXx_NEWLINE_xXFemale patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtainedXx_NEWLINE_xXFemale patients who are pregnant are not eligible; Note: a pregnancy test is required for female patients of childbearing potential prior to study entryXx_NEWLINE_xXFemale patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required* Note: women of child-bearing potential must agree to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity beginning with the screening visit and for the duration of study participation, through 120 days beyond last dose of MK-3475 administration; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year* 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 immediatelyXx_NEWLINE_xXFemale patients who are pregnant are ineligibleXx_NEWLINE_xXFemale patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtainedXx_NEWLINE_xXRECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Female patients of childbearing potential must have a negative serum or urine pregnancy testXx_NEWLINE_xXNON-PROGRESSED DIPG (STRATUM 2): Female patients of childbearing potential must have a negative serum or urine pregnancy testXx_NEWLINE_xXFemale patients who are pregnant are ineligibleXx_NEWLINE_xXFemale patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtainedXx_NEWLINE_xXFemale patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to starting study drugXx_NEWLINE_xXFemale patients of childbearing potential must have a negative serum or urine pregnancy testXx_NEWLINE_xXFemale patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtainedXx_NEWLINE_xXWomen of childbearing potential should be advised to avoid becoming pregnant while receiving InO; women should not breast-feed during treatment with InO and for at least 2 months after the final dose* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days of starting protocol therapy* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of InO* Men with female partners of childbearing potential should use effective contraception during treatment with InO and for at least 5 months after the last dose of InO* Lactating females are not eligible unless they agree not to breastfeed their infantsXx_NEWLINE_xXPregnancy and breast feeding* Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential* Lactating females who plan to breastfeed their infants* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participationXx_NEWLINE_xXFemale patients who are pregnant; a pregnancy test is required for female patients of childbearing potentialXx_NEWLINE_xXThe study drug must not be administered to pregnant women or nursing mothers; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)Xx_NEWLINE_xX \ No newline at end of file