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Congenital Abnormalities clinical trials

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NCT ID: NCT00758108 Completed - Mental Retardation Clinical Trials

Characterization of WAGR Syndrome and Other Chromosome 11 Gene Deletions

Start date: September 11, 2008
Phase:
Study type: Observational

This study will explore conditions caused by the absence of certain genes on chromosome 11. These conditions include WAGR syndrome, which is characterized by a kidney tumor called Wilm s tumor, aniridia (absence of the iris of the eye), genital and urinary abnormalities, mental retardation, and possibly other symptoms. This study will examine how the genes on chromosome 11 affect people and whether the absence of specific genes is associated with specific symptoms. Healthy normal volunteers, people with isolated aniridia, and people with WAGR or another chromosome 11 gene deletion may be eligible for this study. Participants must be at least 6 years old. Parents of patients may also participate for genetic studies. Participants undergo some or all of the following procedures, depending on whether they are a child, adult, healthy volunteer or parent of a patient: - Medical history and physical examination, eye examination, blood, urine and saliva tests, electrocardiogram (EKG) and electroencephalogram (EEG) - X-rays, scans and other tests to measure body composition (fat, muscle and bone development and thickness) and MRI to examine the eyes and the brain and to measure abdominal fat - Ultrasound studies of the kidneys, ovaries and uterus (in females) and testes (in males) - Meal tests, food diaries and food preference tests - Questionnaires about eating and sleep habits, personality and character traits and responses to pain and injury - Neuropsychological tests - Tests of resting metabolic rate, energy expenditure and glucose (sugar) tolerance - Hot and cold sensitivity tests, vibration sensitivity test, cold tolerance test and smell identification test - Eye and hearing tests - Nerve conduction studies and study of sensory information conduction from peripheral nerves to the spinal cord and brain - Computer photography - Evaluation by sub-specialists (e.g., endocrinologist, ophthalmologist, physiatrist, neurologist or others) as indicated by the patient s medical history and test results

NCT ID: NCT00742755 Completed - Breast Cancer Clinical Trials

Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women

Start date: September 2003
Phase: N/A
Study type: Interventional

Develop and evaluate a peer navigator intervention to assist Korean women with a potential breast abnormality, who have missed their first follow-up appointment, to complete all diagnostic follow-up tests.

NCT ID: NCT00741858 Completed - Chiari Malformation Clinical Trials

Duragen Versus Duraguard in Chiari Surgery

Start date: April 2003
Phase: Phase 3
Study type: Interventional

The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.

NCT ID: NCT00724789 Completed - Pregnancy Clinical Trials

Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

Start date: November 2000
Phase:
Study type: Observational

The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.

NCT ID: NCT00722059 Completed - Breast Neoplasms Clinical Trials

Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

Start date: April 2006
Phase: Phase 0
Study type: Interventional

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

NCT ID: NCT00694109 Completed - Clinical trials for Hypercholesterolemia

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Start date: April 2008
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.

NCT ID: NCT00639535 Completed - Breast Disease Clinical Trials

Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities

Start date: January 2002
Phase:
Study type: Observational

This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. In addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured. The MRI studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. Multifocal pathology can be challenging in determining site(s) for biopsy. PET scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. A further drawback of PET is the lack of ability to observe lesions less than 3-4mm in diameter. In select cases the combination of MR and PET/CT is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.

NCT ID: NCT00628537 Completed - Hand Deformities Clinical Trials

Prevention of Post-Stroke Hand/Wrist Flexion Deformity

Start date: April 2004
Phase: Phase 1
Study type: Interventional

The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.

NCT ID: NCT00616135 Completed - Breast Neoplasms Clinical Trials

Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

RESTORE-2
Start date: June 2008
Phase: Phase 4
Study type: Interventional

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).

NCT ID: NCT00607373 Completed - Clinical trials for Hypercholesterolemia

Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia

RADICHOL 1
Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.