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Congenital Abnormalities clinical trials

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NCT ID: NCT01270477 Terminated - Clinical trials for Wound (Morphologic Abnormality)

Hyperbaric Oxygen Treatment as Adjuvant Treatment for Frost Injury

FROST
Start date: January 2011
Phase: N/A
Study type: Interventional

The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage. The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment. Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.

NCT ID: NCT01212965 Terminated - Clinical trials for Lymphatic Malformations

Selenium in the Treatment of Complicated Lymphatic Malformations

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials. Hypotheses: - Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations - Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.

NCT ID: NCT01085513 Terminated - Clinical trials for Intestinal Abnormalities

Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy

Start date: February 2009
Phase: N/A
Study type: Interventional

Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world. A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity. This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved. This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

NCT ID: NCT01007357 Terminated - Clinical trials for Diffuse and Focal Abnormalities of the Liver and Pancreas

Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation

Start date: December 15, 2009
Phase: N/A
Study type: Interventional

This project will facilitate the optimization of body MR imaging at 3 Tesla.

NCT ID: NCT00849888 Terminated - DiGeorge Anomaly Clinical Trials

Serum-Free Thymus Transplantation in DiGeorge Anomaly

SerumFree
Start date: April 2008
Phase: Phase 1
Study type: Interventional

The study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is a safe and effective treatment for atypical and typical complete DiGeorge anomaly. [Funding Source - FDA OOPD]

NCT ID: NCT00830401 Terminated - Clinical trials for Minor Intra-uterine Abnormalities

The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases

Start date: June 2007
Phase: Phase 2
Study type: Interventional

This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.

NCT ID: NCT00670956 Terminated - Clinical trials for Congenital Cystic Adenomatoid Malformation

Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)

CCAM Steroids
Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration

NCT ID: NCT00590291 Terminated - Clinical trials for Coronary Artery Disease

Molecular Determinants of Coronaruy Artery Disease

GeneQuest
Start date: January 1995
Phase:
Study type: Observational

The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD) or Arteriovenous Malformation (AVM).

NCT ID: NCT00579150 Terminated - Type 2 Diabetes Clinical Trials

Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

Exenatide
Start date: January 2009
Phase: Phase 4
Study type: Observational

This is an observational, prospective cohort study describing pregnancy outcomes in women with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any formulation of exenatide during pregnancy. The pregnancy registry will compare the occurrence of the pregnancy outcomes of interest with those collected from a prospective group of women with pre-existing type 2 diabetes who have been exposed to one or more antidiabetic medications other than exenatide during pregnancy. Insulin exposures are acceptable in both groups but must be in addition to one or more other antidiabetic medications in the non-exenatide group. The primary study objective is to evaluate the percentage of major birth defects (i.e., those that caused significant functional or cosmetic impairment, required surgery, or were life-limiting) following use of exenatide during pregnancy for treatment of type 2 diabetes compared to the percentage of major birth defects following use of one or more antidiabetic medications other than exenatide during pregnancy for treatment of type 2 diabetes. The secondary objectives of the Exenatide Pregnancy Registry are to evaluate the percentage of other adverse pregnancy outcomes (e.g., spontaneous abortion, stillbirth, preterm birth) and any potential impact of exenatide use during breastfeeding among pregnancies or births in women who used exenatide for pre-existing type 2 diabetes: This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The Exenatide Pregnancy Registry is sponsored by AstraZeneca and is managed by INC Research, LLC. The scientific conduct and analysis of the Registry is overseen by a Registry Review Committee (RRC) consisting of experts in maternal and fetal medicine, teratology/genetics, epidemiology, type 2 diabetes in pregnancy and/or pediatrics.

NCT ID: NCT00543309 Terminated - Clinical trials for Heart Defects, Congenital

Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations. Although mortality following the Fontan operation is now uncommon, early postoperative morbidity including prolonged postoperative chest tube drainage and hospitalization remains significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory therapies in the perioperative period is unknown and practice varies widely between centers. The investigators will propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery. The investigators plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile. The investigators hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery.