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Genetic Disorders clinical trials

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NCT ID: NCT03911531 Recruiting - Genetic Disorders Clinical Trials

Whole Exome Sequencing and Whole Genome Sequencing for Nonimmune Fetal/Neonatal Hydrops

Start date: January 15, 2019
Phase:
Study type: Observational

Brief Summary: Nonimmune hydrops fetalis (NIHF) is a potentially fatal condition characterized by abnormal fluid accumulation in two or more fetal compartments. Numerous etiologies may lead to NIHF, and the underlying cause often remains unclear (1). The current standard of genetic diagnostic testing includes a fetal karyotype and chromosomal microarray (CMA), with an option to pursue single gene testing on amniocytes collected by amniocentesis (2). A large subgroup of the NIHF causes includes single gene disorders that are not diagnosed with the standard genetic workup for hydrops. Currently, nearly 1 in 5 cases of NIHF is defined as idiopathic, meaning there is no identified etiology (2). The investigators believe this is because the causes of NIHF are not completely investigated, specifically single gene disorders. Our research study aims to increase the diagnostic yield by performing whole exome sequencing (WES) and whole genome sequencing (WGS) on prenatal and neonatal NIHF cases when standard genetic testing is negative, identifying known and new genes, thus providing vital information to families regarding the specific diagnosis and risk to future pregnancies. The investigators plan to perform WES as the initial diagnostic test. If WES is negative, then the investigators will proceed to perform WGS.

NCT ID: NCT01902901 Completed - Genetic Disorders Clinical Trials

Clinical Implementation of Carrier Status Using Next Generation Sequencing

NextGen
Start date: January 2014
Phase: N/A
Study type: Interventional

This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women & partners) seeking pre-conception carrier testing to assess the impact of the program using Whole Genome Sequencing (WGS). 1. The investigators hypothesize that whole genome sequencing will increase the detection of carrier status for Mendelian recessive and x-linked conditions. 2. The investigators hypothesize that parents will act on the knowledge of their carrier status by making different reproductive choices than parents who do not receive this information. 3. The investigators hypothesize that the psychosocial risks are increased among parents who receive expanded carrier screening using Next Generation Sequencing (NGS) compared with usual care.

NCT ID: NCT01401257 Completed - Clinical trials for Charcot-Marie-Tooth Disease

Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A

Start date: December 2010
Phase: Phase 2
Study type: Interventional

The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease.

NCT ID: NCT00851409 Completed - Clinical trials for Hereditary Angioedema

A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration

OPERA
Start date: June 2009
Phase: Phase 2
Study type: Interventional

Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").

NCT ID: NCT00705055 Completed - Genetic Disorders Clinical Trials

Face Anthropometric Pattern Recognition Technology for Computer Aided Diagnosis of Human Genetic Disorders.

DW-6/2007
Start date: November 2007
Phase: N/A
Study type: Observational

The hypothesis to be tested: After the construction of a database of anthropometric measurements, the system would extract important features of a given facial surface and be able to match it with existing morphometric figures. A given combination of normal and abnormal measurements will open a "probable diagnosis" and a list of "differential diagnosis" that will be expressed as percent of matching in a descendent order to the examiner.

NCT ID: NCT00578435 Completed - Sickle Cell Anemia Clinical Trials

Allogeneic Bone Marrow Transplantation for the Treatment of Genetic Disorders of Erythropoiesis

Start date: January 1994
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine and confirm the role of bone marrow transplantation in the treatment of disorders of the red cell and hemoglobin including sickle cell anemia, thalassemia and diamond blackfan anemia.

NCT ID: NCT00262301 Completed - Clinical trials for Hereditary Angioedema

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Start date: June 2004
Phase: Phase 3
Study type: Interventional

Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

NCT ID: NCT00262288 Completed - Genetic Disorders Clinical Trials

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

NCT ID: NCT00261053 Completed - Genetic Disorders Clinical Trials

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Start date: June 2003
Phase: Phase 2
Study type: Interventional

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

NCT ID: NCT00214448 Not yet recruiting - Genetic Disorders Clinical Trials

Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples

Start date: n/a
Phase: N/A
Study type: Observational

The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.