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Growth Disorder clinical trials

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NCT ID: NCT02769975 Recruiting - Metabolic Disease Clinical Trials

Evaluation of Children With Endocrine and Metabolic-Related Conditions

Start date: July 12, 2016
Phase:
Study type: Observational

Background: Endocrine glands give off hormones. Researchers want to learn more about the disorders that affect these glands in children. These disorders might be caused by changes in genes. Genes contain DNA, which is the blueprint of how a cell works. Researchers want to identify the genes involved in endocrine and metabolic disorders. This might help develop new ways to diagnose and treat the disorders. Objective: To study the inheritance of endocrine or metabolism disorders. Eligibility: Children ages 3month-18 with known or suspected endocrine or metabolism disorders. Family members ages 3months-100. They may participate in the DNA part of the study. Design: Participants will be screened with a review of their medical records. Their parents or guardians will allow the records to be released. Participants will have a clinic visit. This may include a physical exam and medical history. Parents or guardians will give their consent for the study. Participants may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include: Blood, urine, and saliva tests Growth hormone test Pituitary and adrenal function tests Picture of chromosomes Imaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey. Genetic tests Sleep study Medical photographs If surgery is done, a tissue sample will be taken. Participants may have follow-up visits for diagnosis and treatment. Participating relatives will have one visit. This will include medical history and blood and saliva tests. The blood and saliva will be used for DNA testing.

NCT ID: NCT02580032 Completed - Clinical trials for Growth Hormone Deficiency in Children

Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)

Start date: October 5, 2015
Phase:
Study type: Observational

This study is conducted in Europe and the United States of America (USA). The aim of the study is to validate two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).

NCT ID: NCT02428296 Completed - Genetics Clinical Trials

Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation

Start date: April 23, 2015
Phase: Phase 2
Study type: Interventional

Background: - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This gene makes a protein that communicates with other proteins in the body to cause cells to grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one of the proteins in this chemical signaling pathway. Researchers want to learn whether the drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS experience. Objectives: - To measure how the overgrowth of patients with PROS changes over time and whether taking a drug called sirolimus can reduce or stabilize a person s overgrowth. Eligibility: - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene in the person s affected tissues (a somatic mutation). Design: - Participants will be screened with medical history and genetic counseling. - First 6 months: Participants will have their overgrowth monitored. - Next 6 months: Participants will take sirolimus once or twice a day. - Participants will have to visit the clinic several times, and stay in the area for 4 to 5 days each time. - Participants will have a one month-long visit to the clinic. - During clinic visits, participants will have: - Blood and urine tests. - Photographs of their physical features. - Scans, including an MRI and DEXA, and possibly x-rays and CT scans. - For the MRI and CT scans, participants will lie in a machine that takes pictures of their body. - The DEXA involves a small amount of radiation. - They may have: - Non-invasive heart function tests. - Lung function tests. - Participants will have several blood and urine tests between visits. - Participants will complete surveys and keep a diary of their treatment and side effects. - Participants may visit other health specialists or undergo other tests based on side effects. - One month after stopping the study drug, participants will have 1 clinic visit.

NCT ID: NCT02311322 Terminated - Short Stature Clinical Trials

Genetic Causes of Growth Disorders

Start date: December 2, 2014
Phase:
Study type: Observational

Background: - Some growth disorders are caused by a change in genes. Genes are the instructions the body uses to function. Changes in genes often cause them not to work correctly. Researchers want to use a new technology called exome sequencing, to look at many genes at once. This is done by looking at DNA from blood or saliva in a lab. This method may help find the cause of disorders that researchers haven t been able to find using past methods. Objectives: - To better understand genetic causes of growth disorders. Eligibility: - Children and adults with growth disorders and their family members. Design: - Participants will give a small sample of blood and/or saliva. - Researchers will purify DNA from the sample. They will perform exome sequencing and other tests to look for changes in genes. Some participants may receive limited or no genetic tests. Researchers will let them know if exome sequencing is performed. - Participants may have a medical history, physical exam, and lab tests. They may have x-rays or ultrasound tests to study the disorder in their family. - Some participants may be recommended for a specific genetic test from a commercial lab. They may have to pay for that test. - Participants will be told about test results that relate to the growth disorder. This may happen up to years after the testing. They may have to give another blood and/or saliva sample. - Some participants may get results about other health conditions. This will only happen if the information would help the person or their family protect their health. They may have to give another blood and/or saliva sample.

NCT ID: NCT01943084 Completed - Healthy Clinical Trials

A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.

NCT ID: NCT01778023 Completed - Clinical trials for Idiopathic Short Stature

Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.

NCT ID: NCT01578135 Completed - Clinical trials for Small for Gestational Age

French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Start date: March 18, 2007
Phase:
Study type: Observational

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

NCT ID: NCT01543867 Completed - Turner Syndrome Clinical Trials

Safety and Efficacy of Long-term Somatropin Treatment in Children

GrowthWIN II
Start date: January 2001
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

NCT ID: NCT01512095 Withdrawn - Healthy Clinical Trials

Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.

NCT ID: NCT01401244 Completed - Healthy Clinical Trials

Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

Start date: July 14, 2011
Phase: Phase 1
Study type: Interventional

This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.