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Congenital Abnormalities clinical trials

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NCT ID: NCT02011867 Completed - Clinical trials for Inner Ear Malformations

A New Cochlear Implant Electrode For Inner Ear Malformations

Start date: May 2013
Phase: N/A
Study type: Interventional

The custom made device was produced by Med-El Company. It has a "cork" like stopper instead of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations. Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. Another patient had slow extrusion of the electrode most probably due to CSF (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula. CSF fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. The new cochlear implant electrode with "cork" stopper looks promising in preventing the postoperative CSF leak around the electrode.

NCT ID: NCT01969370 Completed - Cancer Clinical Trials

NCGENES: North Carolina Clinical Genomic Evaluation by NextGen Exome Sequencing

NCGENES
Start date: August 2012
Phase: N/A
Study type: Interventional

This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. This sub-project is investigating benefits and harms of providing WES diagnostic and different types of incidental findings to adult patients and parents of pediatric patients who undergo WES because they have symptoms suggesting genetic disease.

NCT ID: NCT01916018 Completed - Clinical trials for Congenital Hypothyroidism

Clinical and Genetic Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis.

HYPOTYGEN
Start date: September 17, 2013
Phase: N/A
Study type: Interventional

Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies. Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.

NCT ID: NCT01915797 Completed - Clinical trials for Tumor and Abnormalities of the Development

Tumor and Development (TED)

TED
Start date: June 1, 2013
Phase:
Study type: Observational

The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.

NCT ID: NCT01907971 Completed - Ebstein Anomaly Clinical Trials

Assessment of Left and Right Ventricular Function in Patients With Ebstein Anomaly With Different Echocardiographic Methods

Start date: August 2013
Phase: N/A
Study type: Observational

Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the tricuspid valve, the right atrium and the right ventricle (RV). Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for the assessment of RV volume and function. To evaluate the right heart function VentriPoint method was designed to assess the RV in a fraction of the time, resulting in better efficacy and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition, the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark is located in 3D space. The aim of the present study is to assess the feasibility, reliability and accuracy of the echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison with measurements obtained by cardiac MRI. In addition to the right ventricle the investigators want to assess the left ventricular function in patients with Ebstein anomaly in this study. By using speckle tracking echocardiography the investigators would like to investigate on the left ventricular contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of the right ventricle. Changes in the myocardial left ventricular structure (non compaction) are also described and may have negative impact on the function. The investigators want to analyze 25-30 patients with Ebstein anomaly including children starting at 11 years of age.

NCT ID: NCT01904448 Completed - Cochlear Aplasia Clinical Trials

Auditory Brainstem Implantation in Young Children

Start date: September 2012
Phase: N/A
Study type: Interventional

To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation. This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial. Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.

NCT ID: NCT01902940 Completed - Clinical trials for Inclusion Body Myositis, Sporadic

Natural History in CCFDN and IBM Syndromes

Start date: June 2013
Phase: N/A
Study type: Observational

So far, only limited data is available regarding the natural course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM). Several criteria and outcome measures have led to contradicting results. The investigators want to retrospectively assess the natural course of the disease in CCFDN and IBM patients according to the data recorded during clinical routine visits.

NCT ID: NCT01881893 Completed - Clinical trials for Heart Defects, Congenital

Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

ACHD-CARE
Start date: June 2013
Phase: N/A
Study type: Interventional

The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.

NCT ID: NCT01881685 Completed - Clinical trials for Abnormality in Fetal Heart Rate or Rhythm

Fetal Intrapartum Heart Rate FHR/ECG Study

Start date: March 2013
Phase:
Study type: Observational [Patient Registry]

The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

NCT ID: NCT01880164 Completed - Spinal Deformity Clinical Trials

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

HEO
Start date: June 2015
Phase: N/A
Study type: Observational

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.