View clinical trials related to Congenital Abnormalities.
Filter by:This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis. In order to enroll subject groups with varying degrees of risk, the study has included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been accomplished with protocol amendments.
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population. The objectives of the UCB AED Pregnancy Registry are: - To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome - To review reported cases of possible birth defects - To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.
This study will examine how the body metabolizes micronutrients, such vitamins, during pregnancy and how genetic make-up influences their metabolism. Vitamin B12 and folate levels in pregnancy have been linked to birth defects, such as neural tube defects, orofacial clefts, and congenital heart disease. Other micronutrient levels may be related to other birth defects or pregnancy complications. This study will characterize the patterns of micronutrient status during pregnancy and compare it with genetic variants and biochemical parameters. Information about the relationship between genes and vitamin metabolism may help doctors advise women about their nutritional requirements during pregnancy to protect their health and the health of their babies. This study is a collaboration between NIH and Trinity College in Dublin, Ireland. Women of Irish origin 18 years of age or older who are receiving prenatal care at the Coombe Women's Hospital in Dublin may be enrolled. Fathers also may participate. Upon entering the study, female participants complete a questionnaire relating to their food and vitamin intake, alcohol consumption, smoking behavior, and use of medications, and provide a blood sample. Additional blood samples are collected during routine clinic visits at about 24 and 34 weeks of pregnancy, and again at delivery and from 6 weeks to 2 months after the baby's birth. Permission will be requested to obtain a blood sample from the umbilical cord at birth after it has been removed from the baby. Fathers of the babies are also asked to answer a short questionnaire and to provide a DNA sample for genetic studies. To collect the DNA, sterile cotton swabs are rubbed around the inside of the mouth to obtain cheek cells from which the DNA is extracted.
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it). Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation.
This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval & Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and cerebral branches. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
3 patients were enrolled in each of 3 study cohorts. There three cohorts were given differing, incrementally larger doses of this phase I drug. The same safety measures are being obtained on all patients. Efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly. The study is structured to include a 24 month drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.
The purpose of this pilot study is to investigate the use of minocycline and doxycycline as medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and giant aneurysms.
It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies. Few studies have addressed this issue in poorly resourced settings. This trial will attempt to determine the benefits, if any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine (only selective) scanning. This will be done by recruiting about 900 women in South Africa, and randomly allocating about half to routine scanning and half to selective scanning groups, and following up their pregnancies.