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dbGaP phs000490 A Study of the Genetic Causes of Complex Pediatric Disorders - pht002969.v1.p1

- 04.11.22 - 10 Formulare, 1 Itemgruppe, 32 Datenelemente, 1 Sprache

Itemgruppe: pht002969

Principal Investigator: Hakon Hakonarson, MD, PhD, Center for Applied Genomics, Children's Hospital of Philadelphia, Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA MeSH: Asthma,Attention Deficit Disorder with Hyperactivity,Dermatitis, Atopic,Gastroesophageal Reflux,Lipoproteins, LDL https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000490 The Center for Applied Genomics (CAG) at the Children's Hospital of Philadelphia (CHOP) is a high-throughput, highly automated genotyping and sequencing facility equipped with state-of-the-art genotyping and sequencing platforms. Children who are treated at the Children's Hospital Healthcare Network and their parents may be eligible to take part in a major initiative to collect more than 100,000 blood samples, covering a wide range of pediatric diseases. A large majority of participants consenting to prospective genomic analyses also consent to analysis of their de-identified electronic medical records (EMRs). EMRs are longitudinal, with a mean duration of 6.5 years. CAG has committed to releasing genotype and phenotype data for 4000 individuals diagnosed with *asthma*, *ADHD*, *atopic dermatitis*, *GERD* (1000 for each), and 1000 individuals on the upper and lower ranges of *Low-Density Lipoprotein* (LDL) levels to dbGaP. We will also release genotype/phenotype of 3000 controls. Relevant phenotype data includes primary diagnoses (ICD9 codes), secondary diagnoses (ICD9 codes), medical procedures/tests conducted in relation to the phenotype, and a listing of relevant medications. Further details of CAG's research programs and capacity are available at: http://www.caglab.org

pht002961.v1.p1

1 Itemgruppe 3 Datenelemente

pht002963.v1.p1

1 Itemgruppe 3 Datenelemente

pht002964.v1.p1

1 Itemgruppe 21 Datenelemente

pht002965.v1.p1

1 Itemgruppe 27 Datenelemente

pht002966.v1.p1

1 Itemgruppe 26 Datenelemente

pht002967.v1.p1

1 Itemgruppe 28 Datenelemente

Table V- Supplemental Asthma Outcomes NIH AHRQ for children

- 24.02.16 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 1 Sprache

Itemgruppen: Characterization of study population for prospective clinical trials, Prospective clinical trial efficacy/ effectiveness outcomes, Observational study outcomes

Documentation part: Table V (Recommendations for supplemental asthma outcomes for NIH- initiated clinical research for children). ODM derived from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4259286/ Background: Asthma clinical research will highly benefit from standardization of major outcomes in terms of definition and assessment methodology. This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing. Objective: National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality (AHRQ) convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with standardized methodology in future asthma clinical research studies. Permission granted by: Michelle Freemer.

Table III- Core Asthma Outcomes NIH AHRQ for children (511 years of age)

- 23.02.16 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Characterization of study population for prospective clinical trials, Prospective clinical trial efficacy/ effectiveness outcomes, Observational study outcomes

Documentation part: Table III [Recommendations for core asthma outcomes for NIH- initiated clinical research for children (5-11 years of age)]. ODM derived from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4259286/ Background: Asthma clinical research will highly benefit from standardization of major outcomes in terms of definition and assessment methodology. This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing. Objective: National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality (AHRQ) convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with standardized methodology in future asthma clinical research studies. Permission granted by: Michelle Freemer.

dbGaP phs001216 A Genome-Wide Association Study for Post-bronchodilator Lung Function in Children with Asthma - Eligibility

- 16.05.23 - 5 Formulare, 1 Itemgruppe, 1 Datenelement, 1 Sprache

Itemgruppe: IG.elig

Principal Investigator: Juan C. Celedon, MD, DrPH, National Institutes of Health, Bethesda, MD, USA MeSH: Asthma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001216 In this study, we conducted a genome-wide association study (GWAS) of post-bronchodilator (BD) FEV1 (forced expiratory volume in 1 second) and FEV1/FVC (forced vital capacity) in Puerto Rican children with asthma. From September 2003 to June 2010, we recruited 618 Puerto Rican children with asthma, which was defined as physician diagnosed asthma and at least one episode of wheezing in the previous year. The recruited children include 267 from public schools in Hartford, Connecticut and 351 from randomly selected households in San Juan, Puerto Rico.

Asthma

pht005785.v1.p1

1 Itemgruppe 5 Datenelemente

pht005786.v1.p1

1 Itemgruppe 5 Datenelemente

pht005787.v1.p1

1 Itemgruppe 6 Datenelemente

pht005788.v1.p1

1 Itemgruppe 5 Datenelemente

Magnesium Sulfate in Bronchial Asthma NCT02455687 - Eligibility Criteria

- 15.06.19 - 1 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.; ODM derived from: https://clinicaltrials.gov/show/NCT02455687 Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids beside the standard treatment for patients with severe asthma attacks. Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled budesonide.

Eligibility Acute Asthma NCT01429415

- 30.11.15 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Magnesium Nebulization Utilization in Management of Pediatric Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01429415

Eligibility Asthma NCT00140439

- 04.04.16 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Improving Asthma Outcomes in an Urban Pediatric Population; ODM derived from: https://clinicaltrials.gov/show/NCT00140439

Eligibility Asthma NCT00392288

- 11.04.16 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT00392288

Eligibility Asthma NCT02054975

- 05.04.16 - 1 Formular, 2 Itemgruppen, 18 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02054975

Eligibility Asthma NCT00583986

- 13.04.16 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD; ODM derived from: https://clinicaltrials.gov/show/NCT00583986

Eligibility Asthma NCT00634517

- 18.04.16 - 1 Formular, 2 Itemgruppen, 19 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00634517

Eligibility Asthma NCT00158834

- 06.01.16 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications; ODM derived from: https://clinicaltrials.gov/show/NCT00158834

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