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Genetic Diseases, Inborn clinical trials

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NCT ID: NCT01927861 Completed - Genetic Disorder Clinical Trials

Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome

Start date: August 19, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia. The aim of the trial is to investigate the long-term efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan syndrome.

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: NCT01826487 Completed - Clinical trials for Nervous System Diseases

Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

ACT DMD
Start date: March 26, 2013
Phase: Phase 3
Study type: Interventional

Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.

NCT ID: NCT01529944 Completed - Genetic Disorder Clinical Trials

Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658

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

This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.

NCT ID: NCT01517048 Completed - Obesity Clinical Trials

Brain-Derived Neurotrophic Factor in Obesity and Brain Function

Start date: January 9, 2012
Phase:
Study type: Observational

Background: - Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause problems with appetite regulation. People with PWS often have behavior and thinking problems. People with MC4R mutations may have problems with attention. These problems may be related to Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain development. Researchers want to study people with PWS and MC4R mutations to see how BDNF is involved in these conditions. Specifically, body weight and brain function will be studied, and compared with healthy volunteers. Objectives: - To study how BDNF affects body weight and brain function in people with PWS and MC4R mutations. Eligibility: - Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations. - Healthy volunteers of any age to act as control participants. Design: - Participants will be screened with a medical history and physical exam. Height, weight, and waist/hip circumferences will be measured. Blood samples will be taken for genetic and other tests. - Participants will fill out questionnaires about eating habits, pain perception, and sleep behavior. - Participants will keep a 3-day food diary to record all food and drinks eaten. - Tests and questionnaires will be given to study thinking, speech, movement, behavior, and mood. Some tests will be done on a computer; other tests will be on paper. Tests may also involve performing tasks with blocks and other objects. - Participants may have other tests as directed. These will include hot and cold sensitivity tests, imaging studies like x-rays, and measurements of body fat and water content. - Treatment will not be provided as part of this study.

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: NCT01343953 Completed - Relapse Clinical Trials

Cord Blood Transplantation in Severe Aplastic Anemia

APCORD
Start date: May 2011
Phase: Phase 2
Study type: Interventional

This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

NCT ID: NCT01294345 Completed - Genetic Disease Clinical Trials

Personalized Genomic Research

Start date: January 24, 2011
Phase:
Study type: Observational

Background: - Congenital malformations, sometimes called birth defects, occur because of a difference in early human development. There are many different types of congenital malformations, and some of these can be caused by changes in genetic material. Researchers are interested in studying individuals with these congenital malformations to better understand the causes and the effects of certain congenital malformations. Objectives: - To understand more about what causes congenital malformations that arise in early human development. - To learn if genetic causes can be found to explain why a person has a congenital malformation. Eligibility: - Individuals who have been diagnosed with a congenital malformation. Design: - Participants will be seen at the National Institutes of Health for a series of visits over 3 to 4 days. Participants will be asked to provide copies of past medical records and test results for review, and will be asked questions about pregnancy/prenatal history, birth, newborn, medical, developmental, and family history. - Parents or siblings of participants may also be asked to provide information for research purposes. - Participants may have additional medical evaluations as part of this study, including any of the following tests: - Physical examinations - Other consultations as clinically indicated - Blood samples for genetic testing - Tissue biopsy for genetic testing - Photographs of affected areas, such as front and side views of the face and other body parts that may be involved in a congenital malformation, like the hands and feet. - Other tests as indicated by a specific malformation, such as organ ultrasounds. - No additional invasive testing, testing requiring sedation, or testing involving radiation is planned for this protocol. These tests, if performed, would involve a separate consent....

NCT ID: NCT00960128 Completed - Clinical trials for Chronic Kidney Disease

Observational Prospective Study on Patients Treated With Norditropin®

Start date: April 1, 2006
Phase: N/A
Study type: Observational

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

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").