1sthealthcenters - Pediatrics

Pediatric RSV Vaccination

Description: RSV followed by parainfluenza virus is the leading cause of lower respiratory tract infection in children world wide. IMMUNOe International Research Centers are conducting a research study to evaluate an investigational nasal vaccine spray to see if it can prevent RSV and parainfluenza virus in young children.

Qualifications Include:
- 1 to 3 and 6 to 24 months of age
- Generally Healthy
- Available for all study visits and telephone calls

The duration of this study is one year. All study related vaccines and visits will be provided at no cost. Participants may be compensated for their time and travel.

For further information contact our study coordinator at 303.773.9000 or email sfalbo@immunoe.com

IMMUNOe Health Centers
6801 S. Yosemite Street
Centennial, CO 80112
303.773.9000

Click here to volunteer for a research study.

Gastroesophageal Reflux Disease (GERD)

Description: Gastroesophageal Reflux Disease (GERD) is when stomach contents like stomach acid and/or bile come back up the esophagus. This can cause inflammation or damage to the tissue. GERD is a result of improper closure of the valve at the top of the stomach. The purpose of this study is to evaluate how an investigational medication called rabeprazole sodium is absorbed, used, and excreted in children 1-11 months of age with GERD. Another purpose of the study is to evaluate the safety and tolerability of the medication in children. The medication used in this study is approved to treat GERD in adults but is still currently in the investigational phase for children.

Current Therapies: Current therapies for this age group include primarily with proton pump inhibitors and H2-blockers. The current therapies are metabolized by a very common pathway and can result in various drug interactions and increased or decreased metabolism of other medications.

Objective: To evaluate the efficacy and safety of an investigational pediatric micro-bead formulation of rabeprazole sodium 2 target dose levels in subjects 1-11 years of age with endoscopically proven GERD.

Study Length: approximately 6-7 weeksNumber of visits: Option 1: 8 in office visits (2 visits approximately 13 hours long) Option 2: 13-17 in office visits (3 visits approximately 6 hours long)Visit content: Blood draws, physical assessments, treatment and symptom surveys/scales

Patient Responsibilities: Patient caregiver will complete a diary for the duration of the study.

Major Inclusions:
- Male or female age 1-11 months

- Diagnosis of GERD based on recurrent vomiting or regurgitation and 1 other symptom: · Poor weight gain, · Irritability, excessive crying, · Disturbed sleep, · Failure to thrive, · Refusal to eat,· Arching back at feedings,· Respiratory symptoms such as wheezing, cough, bronchospasm, laryngospasm, hoarsness, bronchitis, or history of aspiration pneumonia

Exclusion Criteria: · History of/ or current clinically significant medical illness · GERD symptoms secondary to another illness and not deemed to be the primary reason for symptoms · Have taken PPIs or H2-blockers within 3 days of beginning study medication · History of or current peptic ulcer, allergy to proton pump inhibitor or heparin

Participants may receive study medication and physical assessments at no cost during the study. Participants who complete the entire study will be compensated $45 per completed study visit.

For further information call 303.773.9000, or email lmicciche@immunoe.com or kmartinez@immunoe.com
IMMUNOe Health Centers
6801 S. Yosemite Street
Centennial, CO 80112
303.773.9000

Click here to volunteer for a research study.

Pediatric Migraine

Description: If your child has a history of migraines, he or she may qualify for a research study of an investigational medication for pediatric migraines.

Qualifications Include:

- Between 12- 17 years old

- History of migraines for more than 6 months

- Available for study

Qualified participants will receive study related medication and study related vists at no cost. Health insurance is not needed. Participants may be compensated for time and travel.

For more information please call 303.773.9000, or email shill@immunoe.com

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