4 Clinical Trials for Various Conditions
This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to the female hormone estrogen from their mother. Estrogen plays a key role in the development of breasts and milk production, as well as the development of the uterus. The effects of these hormones can be seen when babies are examined. Between 6 and 12 months of age, the effects are reduced. Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects. This study has two parts. Part 1 studies the physical development of babies fed different ways. Part 2 studies how hormone levels in babies differ depending on what they are being fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may choose to have their babies evaluated from one to four times. Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 months of age who weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or endocrine problems may be eligible for this study. Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or cow s milk will be included. Study procedures include the following: Part 1 * Feeding history: the parent provides information about the baby s dietary intake since birth. * Length, weight, and head circumference: the baby s measurements are taken. * Physical examination: the baby s physical maturity is assessed by examination of the skin, breasts, and external sex organs. * Breast secretions: the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life. If the substance appears, a specimen will be collected. * Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining. Part 2 * Feeding history and length, weight and head circumference measurements as described above. * Urine: a urine sample is collected in a cotton diaper or a urine collection bag. * aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk. * Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old babies. * Blood: some infants have a small blood sample collected by a heel-stick. This study will serve as a basis for a later study about how infant formulas affect infant growth.
This study, conducted at the Children's Hospital of Boston and the Brigham and Women's Hospital in Boston, will examine the natural history of infant development in the first year of life and how different types of infant feeding may affect that development. During pregnancy, babies are exposed to the female hormone estrogen from their mothers. Estrogen affects development of breasts and milk production, as well as the development of the uterus, ovaries and possibly other hormonally responsive organs in both males and females. Between 6 and 12 months of age, the effects are reduced. Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects. This study will examine the natural history of estrogen activity in infants on different feeding regimens, breast milk, cow's milk, and soy milk and will serve as preparation for a larger study of the effects of soy formula on estrogen activity in infants. Full-term female babies (37 to 41 weeks gestational age at birth) from 0 to 12 months of age and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or endocrine problems may be eligible for this study. Males must have palpable testes. Babies being fed a diet of breast milk, soy milk, or cow's milk will be included. Study procedures include the following: * History of the baby's dietary intake since birth, provided by the parent; * Ultrasound measurement of the uterus, ovaries, and breasts in female babies; the testes, prostate, and breasts in males; and the thymus, thyroid, and kidneys in all babies; * Measurements of all babies' weight, length, and head circumference.
Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill. To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours. This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.