[c09aa8]: / clusters / 9knumclustersv2 / clust_217.txt

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Women of childbearing potential (? months of non-therapy-induced amenorrhea or surgically sterile) must have had a negative serum pregnancy test within the past days and must use a birth control method in addition to barrier methods (condoms).
Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
Pregnant or breast-feeding women will not be entered on this study; women of childbearing potential must obtain a pregnancy test; child-bearing potential is defined as having neither of the following:\r\n* >= months of non-therapy-induced amenorrhea)\r\n* Surgically sterile (absence of ovaries and/or uterus)
Women who are pregnant or nursing a child may not take part in this study; subjects of childbearing ability must agree, with the study doctor, on a method of birth control to use throughout the study; subjects who think they have gotten pregnant during the study must notify the study doctor immediately; pregnant women will be taken out of the study
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< IU human chorionic gonadotropin [HCG]/L) within hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC- or nab-paclitaxel; all men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment
Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within weeks of study registration).
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. a) Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide).
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative urine pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (a) appropriate method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least weeks after study drug is stopped; prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Pregnancy or breastfeeding; a pregnancy test must be performed within days prior to ibrutinib initiation in women of childbearing potential; pregnant women; breastfeeding must be discontinued because of unknown but potential risks in the nursing infant
Women of childbearing potential must have a negative pregnancy test; women of childbearing potential are defined as all women except women who are postmenopausal or who have had a hysterectomy; postmenopausal will be defined as women over the age of who have not had a menstrual period in at least one year; breastfeeding should be discontinued if the mother is treated with E TCR transduced peripheral blood lymphocyte (PBL); these potential risks may also apply to other agents used in this study
Women who are pregnant or breast-feeding; NOTE: Premenopausal women on ovarian suppression therapy are still considered of childbearing potential; women of childbearing potential and men must be strongly advised to use an accepted and effective method of non-hormonal contraception; acceptable contraception includes barrier methods (e.g., condoms or diaphragm) or intrauterine devices (IUDs) (these may include low-dose hormones at the discretion of the study chair)
Women who are pregnant or lactating. Women of childbearing potential must have a negative serum or urine pregnancy test performed within days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment.
Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; postmenopausal women must be amenorrheic for at least months to be considered of non-childbearing potential; women must continue birth control for the duration of the trial and at least months after the last dose of study drug; pregnant or breast-feeding women are excluded; all WOCBP must have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study
Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device [IUD], diaphragm, abstinence, or condoms by their partner) over the entire course of the study; women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for weeks ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; women of childbearing 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; women must not be breastfeeding
Women of child-bearing potential must have a negative pregnancy test within days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for months after radiation; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= year
Nursing women, women of childbearing potential with positive blood pregnancy test within days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device [IUD], diaphragm, abstinence, or condoms by their partner) over the entire course of the study
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent\r\n* Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence [no sexual intercourse] or surgical sterilization)
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< IU human chorionic gonadotropin [HCG]/L) within hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for months or without previous surgical sterilization, must have a negative urine pregnancy test within days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least weeks after study drug is stopped; women of childbearing potential and men with a sexual partner of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for at least months thereafter; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cisplatin
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
Pregnant women and women who are breast feeding are excluded; negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period; pregnancy testing will be carried out within two weeks prior to administration of radioiodinated H in females of childbearing age
Women who are able to conceive and unwilling to practice and effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within days prior to treatment
Women who are pregnant (confirmed by a serum pregnancy test in females of reproductive potential) or breast-feeding; women of child-bearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment (unless the subject or subjects partner(s) is sterile (i.e. women who have had a hysterectomy or have been post-menopausal for at least twelve consecutive months) or remain abstinent, men and women of reproductive potential must agree to use TWO of the following forms of birth control every time they have sex throughout the study and for up to months following discontinuation of study drug: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicidal, intrauterine device (IUD), or surgical sterilization while participating in this study; hormonal birth control methods are not permitted
Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than months post menopause must have a negative serum pregnancy test documented prior to study entry
Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving treatment with guadecitabine, LDAC, or IC and for at least months after completing treatment.
Women who are pregnant or lactating, or who are of childbearing potential , and men\n who do not use a barrier method
Adequate birth control in sexually active women of childbearing potential
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with HDACI and radiation; women of childbearing age and men sexually active with woman of childbearing age must agree to an acceptable method of birth control (double barrier) while on study
Non pregnant and non-nursing; treatment under this protocol would expose a fetus to significant risks; women of childbearing potential should have a negative pregnancy test prior to study entry; women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
Women of childbearing potential and fertile men who are not practicing or who are\n unwilling to practice birth control while enrolled in the study until at least \n weeks after the last milatuzumab infusion
Patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test within days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Women of childbearing potential must have a negative serum pregnancy test within days from day of study drug; both men and women must be willing to use two methods of contraception, one of them being a barrier method during the study and for months after last study drug administration
Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and for days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than months.
Women and men of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least days after the last administration of study medication. A serum pregnancy test within hours prior to the initiation of therapy will be required for women of childbearing potential.
Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days from day of study drug; both men and women must be willing to use two methods of contraception, one of them being a barrier method during the study and for months after last study drug administration
Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to months following the last dose of the study drug, in a manner such that risk of pregnancy is minimized; surgical sterilization, intrauterine device, birth control pills, or barrier method (e.g. condom and/or diaphragm with spermicidal agents) are acceptable forms of birth control; women of childbearing potential must have a negative pregnancy test (serum) within days prior to treatment; a pregnancy test is not required for registration; women who have not menstruated for more than years will be considered postmenopausal, thus not of childbearing potential
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within days prior to entry; patients of both genders must practice birth control during treatment and for four months after treatment
Men 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 study
Women of childbearing potential must have a negative serum pregnancy test within days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
Men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative urine pregnancy test within weeks prior to first infusion
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of childbearing 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; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men and women of reproductive potential who are not using effective birth control methods\r\nNote: women of childbearing potential must have a negative serum pregnancy test =< days prior to registration/randomization; adequate contraception must be used while receiving study drug and for weeks after the last dose of study drug, by both women and men and by both patient and partner; men who have a partner of childbearing potential should also avoid fathering a child for months after the last dose of study drug
Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ? hours prior to Day of study.
Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control; women of childbearing potential must undergo a pregnancy test within seven days of starting the study drug
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with -azacitidine; all men and women of childbearing potential must use acceptable methods of birth control throughout the study
Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test - days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
Women of childbearing potential must have a negative serum pregnancy test within days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
Women who are pregnant or breast feeding, or women/men of reproductive potential who are not using and unwilling to practice an effective method of birth control; (women of childbearing potential must have a negative serum pregnancy test within days prior to administration of pasireotide and RAD)
Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK
Women of childbearing potential must have a negative pregnancy test performed within days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day of study and for days after last pembrolizumab administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ? hours prior to Day of study.
of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following:
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Women of childbearing potential must have a negative serum or urine pregnancy test performed ? days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the months following completion of study treatment.
Non-pregnant and non-nursing women\r\n* Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of treatment\r\n* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Women of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an intentional pregnancy
Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; women of childbearing potential must have a negative serum pregnancy test within hrs prior to receiving the first dose of study medication
Women able to conceive and unwilling to practice an effective method of birth control from screening until days after discontinuing study treatment (women of childbearing potential must have a negative serum pregnancy test within days prior to first dose of PQR).
Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women.
Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
Pregnancy or breastfeeding; women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy; prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Women of child-bearing potential must be willing to practice acceptable methods of birth control. Additionally, women of childbearing potential must have a negative serum pregnancy test within days prior to the first dose of study medication.
Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for weeks after the last AGS-CF infusion administration
Women of childbearing potential must have a negative pregnancy test at baseline prior to receiving any study drug and must practice effective contraception while on study; (pregnant or lactating patients are excluded)
Women of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least days after the last administration of study medication. A serum pregnancy test within hours prior to the initiation of therapy will be required for women of childbearing potential.
Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control; all WOCBP MUST have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study; in addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
Women of childbearing potential must have a negative serum pregnancy test within days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study; oral, implantable, or injectable contraceptives may be affected by cytochrome P interactions, and are therefore not considered effective for this study
Pregnant or lactating women are not eligible; women of childbearing potential must have a negative serum pregnancy test completed within days of study entry, and use an appropriate form of birth control throughout the trial period
Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using reliable forms of birth control
Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant; men should be advised to not father a child while on treatment; both women of childbearing potential and men must agree to practice effective methods of contraception
Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control\r\n* FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice
Women of childbearing potential and their male partners must agree to use TWO effective forms of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for two months following the last dose of study medications; effective birth control methods are: copper IUD [intrauterine device], diaphragm/cervical cap/shield, spermicide, contraceptive sponge, condoms; women of childbearing potential must have a negative pregnancy test within seven days before starting study medications; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last months; pregnancy test to be performed no greater than days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
Pregnant women will also be excluded (Phase I, part B and Phase II); all female participants who are pregnant or become pregnant over the course of the study are not eligible to participate; women of childbearing potential will be asked to complete a blood pregnancy test (using teaspoon of blood drawn from a vein by needle stick) at their first study visit, and the test must be negative before the woman can continue in the study; women of childbearing potential will be asked to agree to use appropriate contraceptive measures for the duration of the study; participants with medically verified menopausal status (e.g., via tests of ovarian functioning documented in the participants medical record) will not be asked to complete a blood pregnancy test
Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through days after the last treatment
Negative serum pregnancy test (in women of childbearing potential) =< days prior to Step ; women of childbearing potential and men who are sexually active must practice adequate contraception while on study
Women will be excluded if they intend to become or are pregnant or lactating; men and women will be required to take active measures to prevent pregnancy while on the study
Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last months; pregnancy test to be performed no greater than days prior to consent in study; in cases of women with elevated beta (b)-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth control specifications: women who are able to become pregnant must use birth control during the study and for days after
Women of childbearing potential (women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, and women who have had a tubal ligation) are required to have a negative urine pregnancy test within days prior to the first dose of lithium
Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last months; pregnancy test to be performed no greater than days prior to consent in study; in cases of women with elevated beta human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications; women who are able to become pregnant must use birth control during the study and for days after the last ginseng/placebo dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
Note: We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question
Women must indicate that they are still considering future pregnancy and childbearing
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
Pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method
Patients must not be pregnant or breast feeding; women of childbearing potential are required to obtain a negative pregnancy test within days of starting treatment; effective contraception (men and women) must be used in subjects of childbearing potential
Pregnant or breast feeding women are excluded from this study; women of childbearing potential must have a negative pregnancy test within days prior to receiving indocyanine green
Women of childbearing potential not practicing adequate forms of birth control
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.