--- a +++ b/clusters/3009knumclusters/clust_195.txt @@ -0,0 +1,520 @@ +STEP I: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women +STEP II: The following patients will be excluded:\r\n* Pregnant women\r\n* Nursing women +No patients that are known to be pregnant or nursing +Not pregnant and not nursing +Pregnancy and/or nursing females +Nursing mothers are excluded +Women who are pregnant or nursing +Subject is pregnant, nursing or intends to become pregnant during the course of the study. +Pregnant or nursing female patients. +Female patients who are pregnant or nursing +Pregnant and nursing women are excluded from this study +Pregnant and nursing females. +Pregnant or nursing women +Pregnant or nursing women +Female patients who are pregnant or nursing are not eligible +Pregnant and nursing mothers are excluded from this study. +Pregnant or nursing women +Pregnant or nursing (lactating) women. +Any of the following:\r\n* Pregnant women\r\n* Nursing women +Females who are pregnant or nursing +Patients who are pregnant or actively nursing an infant are not eligible +Nursing women +Pregnant or nursing (lactating) women +Pregnant or nursing +Pregnant or nursing mothers are excluded +Pregnant/nursing +Pregnant, or nursing female patient Previous treatment +Pregnant or nursing. +Pregnant or nursing women. +Are pregnant and/or nursing +Pregnant or nursing women will be excluded from the study +Women who are pregnant or nursing a child may not take part in this study +Pregnant or nursing females +Women who are pregnant or nursing +Pregnant or nursing women will be excluded from the study +Pregnant women are excluded from this study; nursing mothers should stop breastfeeding to be eligible +For female subjects of childbearing potential: Is pregnant or nursing +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing +Pregnant or nursing +Pregnant and nursing subjects are excluded +Nursing women +Pregnant/nursing female +Pregnant or nursing +Pregnant or nursing women are excluded +Patients who are pregnant or nursing +Pregnant or nursing females. +Pregnant or nursing female patients +Pregnant or nursing women +Pregnant or nursing women +Nursing women +Pregnant or nursing female subjects +Pregnant or nursing women +Female subjects who are pregnant, intend to become pregnant or are nursing +Pregnant or nursing women +Pregnant or nursing female participants +Patients who are pregnant or nursing. +Pregnant and nursing women +Pregnant or nursing women +Pregnant or nursing women +Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child +Nursing or pregnant women +Patient is pregnant or nursing +Nursing or pregnant women +Pregnant or nursing female subjects +Pregnant or nursing female participants +Women who are pregnant or nursing. +Pregnant or nursing +Patients must not be pregnant or nursing +Pregnant or nursing female participants +Females who are pregnant or nursing +Pregnant or nursing women +Female patients who are pregnant or nursing are not eligible +Women who are pregnant or nursing or plan to become pregnant or nurse during the course of the study +Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment +Female patients who are pregnant or nursing. +Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. +Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP) +Pregnant or nursing women +Pregnant and nursing women are excluded from this study +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing women +Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants +Women who are pregnant or nursing. +Nursing or pregnant women +Any of the following:\r\n* Pregnant women\r\n* Nursing women +May not be pregnant or nursing +Be female and pregnant or nursing. +Pregnant or nursing women +Pregnant or nursing (lactating) women; breastfeeding should be discontinued +Pregnant or nursing women +Women who are pregnant, nursing, or who plan to become pregnant while in the trial +Pregnant or nursing female participants +Pregnant or nursing female participants +Non-pregnant and non-nursing; pregnant and nursing patients may not be enrolled; women and men of reproductive potential must agree to use acceptable forms of contraception during the study +Pregnant or nursing +Female patients who are pregnant or nursing are not eligible +Patients who are pregnant or nursing +Pregnant or nursing women +Nursing women +Pregnant and nursing women are excluded from this study +Pregnant or nursing +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing women +Pregnant or nursing women +Subjects who are pregnant or nursing +Pregnant or nursing women are excluded from this study +Patients who are pregnant or nursing +Female subjects who are pregnant, intend to become pregnant or are nursing +Pregnant or nursing +Subjects must not be pregnant or nursing +Pregnant or nursing patients +Pregnant and nursing women are excluded +Pregnant or nursing +Patients who are pregnant or nursing are excluded +Pregnant or nursing (lactating) women +Pregnant or nursing +PHASE I: Patients must not be pregnant or nursing as the potential of this regimen to harm nursing infants has not been evaluated +PHASE II: Patients must not be pregnant or nursing as the potential of this regimen to harm nursing infants has not been evaluated +Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing women +Pregnant or nursing (lactating) women +Nursing women +Patients who are pregnant or nursing +Pregnant or nursing women +Patients who are pregnant or nursing +Pregnant or nursing women. +Pregnant or nursing women +Pregnant or nursing patients +Pregnant women or nursing mothers +Pregnant and nursing mothers are excluded from this study +Female patients who are either pregnant or nursing. +Pregnant or nursing women +Pregnant or nursing women +Pregnant or nursing women +Nursing women may participate only if nursing is discontinued +Women who are pregnant or nursing +Subjects must not be pregnant or nursing +Pregnant or nursing women +Pregnant or nursing +Study drug must not be administered to pregnant women or nursing mothers +Patients who are pregnant or nursing +Subjects must not be pregnant or nursing +Pregnant or nursing (lactating) women +Pregnant women or nursing mothers +Not pregnant and not nursing +Pregnant or nursing (lactating) women +Women who are pregnant or nursing +Patients who are pregnant or nursing (Turnstile I) +Women who are pregnant or nursing. +Subjects who are pregnant or nursing +Pregnant or nursing female subjects +Pregnant women or nursing mothers +Women who are pregnant or nursing +Subjects must not be pregnant or nursing +Females who are pregnant, intend to become pregnant, or are nursing at the time of randomization. +Pregnant or nursing female patients +Patients who are pregnant or nursing (Turnstile I) +Pregnant women or nursing mothers +Patients who are pregnant or nursing +Are pregnant and/or nursing +Pregnant or nursing women are excluded from this study +EXCLUSION CRITERIA FOR REGISTRATION: pregnant or nursing women are excluded from this study +Patient must not be pregnant because of the risk of harm to the fetus; nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen; women/men of reproductive potential must agree to use an effective contraception method +Pregnant or nursing (lactating) women +Pregnant or nursing women +Pregnancy or nursing patients will be excluded from the study +Pregnant or nursing women +Pregnancy or nursing +Not pregnant or nursing +Pregnant and nursing women. +Pregnant or nursing female participants +Pregnancy or nursing +Women who are pregnant or nursing +Female subjects who are pregnant or nursing +Women who are pregnant or nursing +Pregnant or nursing at the time of signing informed consent +Lactating females must agree to discontinue nursing +Pregnant or nursing women +Pregnant or nursing females. +Nursing or pregnant females or females who plan pregnancy during the duration of the study. +Pregnant or nursing women. +Nursing women +Are not pregnant or nursing; +Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants +Pregnant or nursing +Pregnant or nursing +Female patients who are pregnant or nursing are not eligible +Patients must not be nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants +Patients must not be pregnant or nursing +May not be pregnant or nursing +Patients must not be pregnant or nursing +Subjects known to be pregnant or nursing. +Pregnant or nursing +Pregnant or nursing females +Nursing women who are unwilling to discontinue nursing +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing female patients are excluded from this study +ARM A: Pregnant or nursing women +ARM B: Pregnant or nursing women +DOSE ESCALATION COHORT: Pregnant or nursing +DOSE EXPANSION COHORT: Pregnant or nursing +Any of the following:\r\n* Pregnant women\r\n* Nursing women +Pregnant or nursing women +Pregnant or nursing women +Pregnant women are excluded from this study; nursing women are excluded from this study +Nursing woman +Pregnant women are excluded from this study; nursing women are excluded from this study +Any of the following:\r\n* Pregnant women\r\n* Nursing women +Pregnant or nursing. +Women who are pregnant or nursing +Pregnant or nursing women +Pregnant or nursing +Pregnant or nursing mothers +Pregnant or nursing women +Women who are pregnant or are nursing +Pregnant or nursing female patients +Women who are pregnant or nursing +Patients who are pregnant or nursing are excluded +Pregnancy or nursing Mother +Patients who are pregnant or nursing are excluded +Pregnant/nursing women are excluded from this study because oxaliplatin is an agent with the potential for teratogenic or abortifacient effects +Pregnant and nursing women are excluded from this study +Not pregnant or nursing +Pregnant women or nursing mothers +Pregnant or nursing +Pregnant or nursing +Patients who are pregnant or nursing +Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; bevacizumab should not be administered to nursing women +Pregnant and nursing females. +Patients who are pregnant or nursing +Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study +Pregnant or nursing (lactating) women +Pregnant, planning to become pregnant, or nursing +Pregnant or nursing (lactating) women +Pregnant or nursing women +Non-pregnant and non-nursing +Pregnant or nursing +Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study +Pregnant or nursing women. +Pregnant, planning to become pregnant, or nursing +Pregnant or nursing women +Is pregnant or nursing +Women who are pregnant, nursing, or who plan to become pregnant while in the trial +Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study +Pregnant or nursing +Pregnant or nursing female participants +Women who are pregnant or nursing. +No women who are pregnant or nursing +Currently pregnant, nursing, or wishing to become pregnant during the study +Pregnant or nursing female participants +Pregnant women or nursing women +Women who are pregnant or nursing (lactating). +Patients must be non-pregnant and non-nursing +Pregnant women and/or nursing patients will be excluded from the study +Females who are nursing must agree to discontinue nursing before the first dose of GS-5829 +Pregnant or nursing; or +Women who are pregnant or nursing +Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception +Patients who are pregnant or nursing +Nursing and pregnant females +Pregnant or nursing (lactating) women. +Pregnancy or nursing +Pregnant or nursing +Females who are nursing must agree to discontinue nursing before the first dose of study drug +Women who are pregnant or nursing/breastfeeding +Pregnant or nursing women +Pregnant or nursing females. +Women who are pregnant or nursing (lactating) women +Female patients who are pregnant or nursing (lactating) are not eligible +Pregnant or nursing women will be excluded from the study +Female patients who are pregnant or nursing are not eligible +Female patients who are pregnant or nursing are not eligible +Participants who are pregnant or nursing +Subjects must not be pregnant or nursing +Pregnant or nursing +Women that are pregnant or nursing +Pregnant or nursing. +Pregnant and nursing women +Pregnant or nursing patients will be excluded from the study +Any of the following\r\n* Pregnant women\r\n* Nursing women +Pregnant or nursing women will be excluded from the study +Patients who are pregnant or nursing +Pregnant women and nursing mothers +Pregnant or nursing (lactating) women +Pregnant or nursing women +Pregnant or nursing females +Pregnant and nursing women are excluded from this study +Pregnant or nursing (lactating) women +Patients who are pregnant or nursing +Females who are nursing must agree to discontinue nursing before the first dose of MMB +Pregnant or nursing female subjects +Patients who are pregnant or nursing are not eligible +Pregnant or nursing +Nursing women +Pregnant and nursing women are excluded from this study +Women who are pregnant or nursing/breastfeeding. +Pregnant or nursing (lactating) women +Pregnant or nursing (lactating) women +Pregnant or nursing within past 6 months, or plans to become pregnant in the next year +Pregnant or nursing (lactating) women +Pregnant or nursing women +Pregnant women and nursing women are excluded from this study +Patient must not be pregnant or nursing +Are pregnant or nursing, or intending to become pregnant within the duration of the study +Pregnant or nursing +Pregnant or nursing +Patients pregnant or nursing +Pregnant or nursing (lactating) women. +Pregnant or nursing women +Pregnant or nursing within past 6 months +Non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control +Pregnant or nursing women +Patients who are pregnant or nursing +Pregnant or nursing (lactating) women. +Nursing female. +Pregnant or nursing women +Pregnant or nursing females +Nursing women +Pregnant women and nursing patients will be excluded +Patient is pregnant or nursing +not pregnant or nursing; Female participants must not breastfeed during the study and for a period of 30 days following the last dose. +Pregnant or nursing +Patients who are pregnant or nursing. +Nursing women +Not pregnant or nursing +Nursing women. +Pregnant or nursing women +Pregnancy and/or nursing mothers +Pregnant or nursing (lactating) women +Subject is nursing or intends to begin nursing during the course of the study +Pregnant or nursing +Pregnant or nursing (lactating) women +Pregnancy or nursing +Pregnant or nursing female patients +Nursing or pregnant. +Pregnant or nursing women may not participate in this trial +Pregnant or nursing female subjects +Pregnant and nursing patients will be excluded from the study +Pregnant or nursing patients will be excluded from the study +Pregnant, nursing or planning to become pregnant +Pregnant or nursing women. +Patients who are pregnant, nursing, or who wish to become pregnant during the study +Nursing women +Patients who are pregnant or nursing +Is, within 2 weeks prior to Day 1, nursing. +Pregnant and nursing women are excluded from this study +Females who are pregnant or nursing. +Pregnant or nursing female patients. +Pregnant or nursing women +Pregnant or nursing female patients +Pregnant or nursing women +Pregnant or nursing +Is nursing or pregnant +Females who are pregnant or currently nursing. +Pregnant or nursing women. +Pregnant or nursing women +Pregnant or nursing (lactating) women +Pregnant or nursing females +Women who are pregnant and/or nursing +Pregnant women or nursing women +Currently pregnant or nursing. +Is nursing or pregnant +Pregnant or nursing females; +patient was pregnant or nursing at the time of entry +Pregnant or nursing women; breastfeeding must be discontinued prior to treatment +Pregnant or nursing females. +Females who are nursing. +Pregnant or nursing +Patients must not be pregnant or nursing +Pregnant or nursing female patients +Patients must not be pregnant or nursing +Participant is nursing or intends to begin nursing during the course of the study +Subject is pregnant or nursing an infant +Are pregnant or nursing +Pregnant or nursing women +Pregnant or nursing +Pregnant or nursing females. +Women who are pregnant or nursing. +Pregnant or nursing women +Pregnant or nursing mothers +Pregnant or nursing women. Pregnant and nursing patients are excluded because the effects of CWP232291 on a fetus or nursing child are unknown. +Pregnant or nursing +Participants who are pregnant or nursing +Pregnant or nursing women Part 3 Exclusion Criteria: +Pregnant or nursing women Part 4 Exclusion Criteria: +Pregnant or nursing women +Pregnant or nursing women +Female subjects cannot be pregnant or nursing. +Pregnant or nursing +Pregnant or nursing women will be excluded from study. +Not pregnant or nursing +Pregnant or nursing women are excluded +Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment) +Pregnant and nursing women +Female patients who are pregnant or nursing are not eligible +Pregnant or nursing female patients +Patients who are pregnant or nursing +Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment) +Patients who are pregnant or nursing are ineligible +Pregnant or nursing female patients +Pregnant or nursing female patients +Females who are nursing +Pregnant or nursing +Pregnant or nursing +Patient is pregnant or nursing +Subject is pregnant, nursing, or planning to get pregnant during study duration. +Female patients who are pregnant or nursing are not eligible. +Known pregnancy or nursing +Patient is pregnant or nursing +Pregnant or nursing women +Pregnant or nursing female subjects; may be determined in the preoperative evaluation +Pregnant or nursing female participants +Pregnant or nursing women +Participant is pregnant or nursing +Pregnant or nursing women +Women who are pregnant, lactating/nursing or plan to become pregnant +Currently pregnant, nursing or planning to become pregnant +Pregnant women will be excluded; nursing patients will be included +Pregnant or nursing women +Pregnant and nursing women +Pregnant or nursing female patients +Women who are known to be pregnant or nursing +Nursing women +Pregnant or nursing female patients +Subject is pregnant or nursing +Nursing women +Pregnant or nursing (lactating) women +Women who are pregnant or nursing; pregnancy will be confirmed by urine test +Female participants who are pregnant or lactating/nursing +Women who are nursing +Women who are nursing +Not pregnant or nursing +Pregnant or nursing patients will not be included in the study +Females of childbearing potential who are pregnant or nursing +Currently pregnant, nursing, or wishing to become pregnant during the study +Women who are pregnant, nursing, or who may become pregnant in the next 3 months +Pregnant women or nursing women +Women who are pregnant or nursing +Pregnant or nursing female participants +Women who are pregnant or nursing, or intend to be/do so during the course of the study +Women who are pregnant or nursing +Non-pregnant and non-nursing +Pregnant or nursing women +Pregnancy or nursing women +Nursing women +Pregnant or nursing women +Pregnant or nursing (lactating) women +Nursing or pregnant females +Subject is pregnant or nursing +Nursing or pregnant females +Pregnant or nursing (lactating) women. +Pregnant or nursing +Pregnant or nursing +If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study +Women who are pregnant or nursing except when the indication is an abnormal cell-free DNA test +Females who are pregnant or nursing +Females who are pregnant or nursing +Women who are pregnant or nursing +Pregnant or nursing participants +Pregnant or nursing +Pregnant or nursing +Nursing female subjects +Females who are pregnant or nursing +Pregnant or nursing (lactating) women +Patient is pregnant or nursing +Pregnant or nursing +Pregnant or nursing +Pregnant or nursing females +The patient must not be pregnant or nursing +Pregnant and/or nursing women +Patients who are pregnant or nursing +HEALTHY VOLUNTEER: Females who are pregnant or nursing or are actively lactating +PATIENT: Females who are pregnant or nursing +Pregnant or nursing female +Female patients who are pregnant or nursing +Female participants/volunteers who are pregnant or nursing +Female patients who are pregnant or nursing +Pregnancy or nursing patients +Pregnant or nursing +Women who are pregnant or nursing +Pregnant or nursing females. +Pregnant or nursing (lactating) +Pregnant or nursing female +Pregnant or nursing female +Pregnant or nursing female +Pregnant or nursing female +Pregnant or nursing females +Pregnant or nursing female +Pregnant or nursing females +Pregnant or nursing women +Patient is pregnant or nursing; +Females who are pregnant or nursing. +Patient is pregnant or nursing +Females who are pregnant or nursing +Pregnancy or nursing mothers +Pregnant or nursing patients will be excluded from the study +Patient is pregnant or nursing +Pregnant or nursing female subjects +Women who are pregnant or nursing +Subjects must not be pregnant or nursing +Pregnant or nursing female +Pregnant or nursing +Are pregnant or nursing +Females who are pregnant or nursing +Pregnant or nursing +Known pregnant or nursing patients +Subjects who are pregnant or nursing +Pregnant or nursing patients will be excluded from the study +Females who are pregnant or nursing +Pregnant or nursing women +Pregnant or nursing +Pregnant and nursing women +Pregnant or nursing women +Pregnant or nursing +Pregnant or nursing +Pregnant or nursing +Pregnant or nursing female patients +Pregnant or nursing patients will be excluded from the study