25 Clinical Trials for Various Conditions
The purpose of this study is to determine whether the transplacental gradients for 6 polyols and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to normal pregnancies and b) to determine the relative contributions of transplacental transport vs production by the conceptus of both inositol (the major polyol) and mannose in IUGR and normal pregnancies using stable isotopic methodology.
Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. It is now accepted that endothelial dysfunction heralds the clinical manifestations of preeclampsia. The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black. SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was used before in many situations especially in sepsis and septic shock patients. Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR) light by tissues perfused with oxygenated blood, and is capable of measuring changes in parenchymal volume tissues. It was used before in many situations (including pregnant patients) to reflect the tissue oxygenations. The investigators are planning to use the SDF and NIRS tools to study the microcirculatory change in preeclamptic subjects and normal pregnant subjects. If these two devices are able to determine any changes this should stand as a baseline for future studies in this field.
The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as they relate to normal pregnancies and those pregnancies complicated by placenta abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum, placental, and cord blood samples will be obtained for each subject. A medical history will be obtained for each subject. Post-delivery a member of the study team will perform a cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will receive four phone call follow ups to determine if the infant has had any skin changes. If yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed, a blood draw will be performed.
This study will examine levels of hormones, such as estrogen and testosterone, in maternal and umbilical cord blood to compare hormones between mothers who are having twins and mothers who are having one baby. It will investigate whether hormone levels in twin versus singleton pregnancies influence the babies' risk of developing breast, prostate, and testicular cancers later in life. Pregnant women 18 years of age and older who do not have preeclampsia, chronic hypertension, pre-pregnancy or gestational diabetes, thyroid disease, or other major pregnancy complications are eligible for this study. Participants will be recruited from the obstetrics and gynecology practice at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire. Participants will have a blood sample drawn from their arm during their third trimester prenatal visit and again when they are admitted to the hospital for delivery. After the baby is born, a blood sample will be collected from the cut umbilical cord. Information about the pregnancy and delivery will be collected from the mother's medical chart, and information about the baby's size will be obtained from the baby's medical chart.
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.
To date very little research has been conducted on pregnant mothers. Research shows that mothers with obesity and gestational diabetes have children who have a higher risk of later developing obesity and diabetes compared to children born to non-obese mothers but the mechanisms are not known. The maternal environment may place these babies at greater risk and it is possible that fat tissue (adipose tissue) releases many chemicals (adipokines and inflammatory cytokines) which may have an impact on the baby. Mothers who have greater amounts of adipose tissue most likely release these adipokines into the baby and it may affect the baby's body composition and/or health. This project will establish if there is a relationship between obesity and adipose tissue inflammation in pregnant mothers, and if there is a link between inflammation and the child's body composition. We will recruit mothers with low risk pregnancies already schedule for a C section at about 36 wk. We will do initial testing at 36 wk, adipose tissue collection at delivery, and conduct post testing at 1 month postpartum on the mother and the baby.
The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.
The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.
This cohort study will examine the clinical utility of genomic sequencing (GS) in patients undergoing prenatal diagnostic procedures (chorionic villus sampling or amniocentesis) for routine indications other than a structural fetal anomaly.
This clinical trial determines if an oral medication taken within 2 days of anticipated ovulation will delay ovulation by 7 days. The study compares oral placebo tablets (control) to oral levonorgestrel, a synthetic hormone, and meloxicam, a non-steroidal anti-inflammatory drug (treatment) in 21 healthy women between the ages of 18 to 40. The control or treatment are taken 48 hours apart in the first and second menstrual cycle, respectively. The first dose is taken when the ovarian follicle has a diameter of 17 mm measured by transvaginal ultrasound. This follicle diameter is found 2 ± 1.0 days before ovulation. Ovulation is determined by a change in urinary hormone levels analyzed in first morning daily urine. The Investigators anticipate that the control cycle will have an interval to ovulation of ≤ 3 days from first placebo to ovulation while a delay of ≥7 days is found between first treatment to ovulation. A second question is to determine the side effects between control versus treatment based on symptoms such as nausea or abdominal cramping, change in blood pressure or pulse rate and the interval in menstrual bleeding. Each study participant has approximately 9 visits during each of two menstrual cycles. The visits between menstrual day 9 (first visit) to largest follicle are 3 to 6 depending upon follicle growth. A blood sample with a transvaginal ultrasound for ovarian follicle diameter is obtained at each visit. The appropriate medication is taken when the ovarian follicle largest diameter is 17 mm. The second dose is taken 2 days later with interim and final visits at 5 and 10 days following first dose. Each participant collects first morning urine from menstrual day 9 to 23. A teaspoonful of morning urine is placed in a storage tube and kept in a refrigerator freezer section until returned at a scheduled visit. All urine samples are kept frozen until analyzed for the metabolites of estrogen and progesterone by a central research laboratory. A change in the ratio of estrogen to progesterone metabolites is indicative of ovulation because more progesterone is secreted after ovulation from the ovary. The primary research outcome compares the interval in days from first dose of medication to ovulation between control and treatment. Secondary outcomes are menstrual cramps, vaginal bleeding, nausea, and headache, and changes in blood pressure, pulse, and interval between menstrual periods in control compared to treatment cycles.
Background: Pregnancy loss is the most common complication of pregnancy. It occurs in roughly one-half of natural conceptions. It most frequently occurs in the first 2 to 3 weeks of pregnancy. Researchers want to look at the lining of the uterus, called the endometrium, to see what role it plays in implantation and miscarriage. Objective: To gain a better understanding of how normal and abnormal endometrium works. Eligibility: Healthy, fertile women ages 18-42 who have had one prior child. Design: Participants will have 3 study visits. At visit 1, participants will have a medical history. They will have a radiologic/imaging review if needed. They will be taught how to monitor their urine luteinizing hormone (LH) at home with an ovulation predictor kit. They will have their second study visit 9 days after their LH surge. At visit 2, participants will take a urine pregnancy test. They will have a physical exam and have blood drawn. They will have a uterine lavage and endometrial biopsy. For this, a speculum will be placed into the vagina. A soft catheter will be inserted through the cervical canal into the uterus. Saline will be added into the uterus and then recovered after 30 seconds. A tissue sample will be taken. About 46 days later, participants will start another round of LH monitoring. They will have a third study visit 9 days after their LH surge. At visit 3, they will repeat the tests from visit 2. Some samples will be used for genetic tests. Participation will last for 3 menstrual cycles. ...
Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been shown to be helpful in treating various types of pain. This study will explore whether tSTM can improve back pain in pregnancy.
Healthy parturients presenting for scheduled cesarean delivery will have blood drawn and measured for microparticles at baseline, immediately after delivery, and at several time points thereafter.
The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.
The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection. The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.
Normal fetal growth is a critical component of a healthy pregnancy and the long-term health of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defining normal and abnormal fetal growth is the development of standards for fetal growth. The study's purpose was to establish standards for normal fetal growth and size for gestational age for 4 racial/ethnic groups of pregnant women with the eventual creation of individualized standards for fetal growth and improvements in fetal weight estimation. These data for a contemporary cohort of pregnant women should provide data for clinical management.
This study will evaluate how the immune system responds to influenza infection and compare how the infection differs in patients with a weakened immune system versus those with a healthy immune system. Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed with influenza A or B may be eligible for this study. Patients with healthy immune systems and weakened immune systems are included. Participants answer questions about how they are feeling and have a physical examination to evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in the nose and washing the nose with salt water and collecting the fluid obtained, or by rubbing the inside of the nose with a swab. Physical examinations are repeated on the days that blood and nasal fluid are collected.
The purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. The samples have been gathered under the sponsorship and approval of the Human Investigations Committees at Yale University, Wayne State University and Pennsylvania Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. Clinical information with patient identifiers is available for these samples and sonographic examinations.
The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.
Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors may find that they are not able to produce female hormones, and they may not be able to have a child. Scientists are trying to find ways to help cancer survivors regain their hormonal function and possibly get pregnant, if they desire. Scientists have developed a method where ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back into her body is called ovarian autotransplantation. Ovarian autotransplantation is a very new technique, and there have only been a small number of women who have had this procedure. So far, only five babies in the world have been born using this technique. The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope to find better ways to use this method to help a woman's ovaries start working again after chemotherapy. If the ovaries start working again, it might be possible to have a baby.
Endometrium is the lining of the uterus. It is where the fertilized egg normally implants during pregnancy. This study was designed to better understand the way(s) that female sex hormones (estrogen and progesterone) cause the uterus to grow and develop. It is known that these hormones are necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown. Researchers would like to identify the genes that are affected by female sex hormones by using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human endometrium). Researchers will select women who have regular monthly menstrual cycles and study them for two cycles; 1. \<TAB\>The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's body temperature and progesterone measurements during the last 14 days (luteal phase) of the menstrual cycle. 2. \<TAB\> The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone that causes the ovary to release the developed egg. Ovarian ultrasounds will be performed before the biopsy to determine development of the egg. Blood tests will be taken on the day of the biopsy to have an overall idea of the hormones circulating in the patient's blood. An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen, estrogen/progesterone, or steroid hormone withdrawal.\<TAB\>
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in patients with complex disease globally.
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening. PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, ifosfamide, and carboplatin followed by peripheral stem cell transplantation in treating patients with refractory cancer.