Innovations and Research: Jacksonville

Safety and Efficacy Evaluation of Topical Moxidex Otic Solution Compared to Moxifloxacin Solution in the Treatment of Acute Otitis Media with Otorrhea through Tympanostomy Tubes (AOMT) (2005-current).  Principal Investigator:  Gary Josephson. MD.  Sub-Investigator:  Laurie Duckworth PhD, ARNP

The Study of Acid Reflux in Children with Asthma (SARCA) (2006-2008).  Principal Investigator:  John Lima, PharmD.  Sub-Investigator:  Laurie Duckworth, PhD, ARNP.

Vestibular Deficits and related impairments in children with otitis media with effusion (2008).  Principal Investigator:  Gary Josephson, MD.  Sub-Investigator:  Laurie Duckworth, PhD, ARNP

Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children: (2007-present).  Sponsor: American Diabetes Association

Principal Investigator: Amanda Lochrie, PhD.  Study Coordinator: Laurie Duckworth, PhD, ARNP.

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. Altus Protocol #0000726. (2007-present).   Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, PhD,  ARNP.

A Phase III, Open-Label Clinical Study Evaluating the Long-Term Safety and Clinical Activity of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. Altus Protocol #0000767. (2007-present).  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, PhD, ARNP

Study of Acid Reflux and Asthma (SARA) (2004-current).  Principal Investigator:  John Lima, Pharm.D.  Sub-Investigator: Laurie Duckworth, PhD, ARNP

Effect of Simple Obesity on Lung Function in Children. (2007).  Principal Investigator:  Jason Lang, MD.  Sub-Investigator:  Laurie Duckworth, PhD, ARNP

A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients with Mild Cystic Fibrosis Lung Disease. Protocol: Inspire 08-108 (TIGER-1). (2007).  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, MSN, ARNP

A randomized, double-blind, double-dummy parallel group study evaluating the safety of fluticasone propionate/salmeterol 100/50mcg HFA (2 inhalations of 50/25mcg) twice daily compared with fluticasone propionate 100mcg HFA (2 inhalations of 50mcg) twice daily in subjects 4-11 years of age with persistent asthma. Protocol SFA106484. (2006-2007).  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, MSN, ARNP

A repeat-dose, open-label, randomized, incomplete block design in pediatric subjects with asthma, ages 4 - 11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following Advair HFA 45/21mcg (2 inhalations), ADVAIR HFA 45/21mcg (2 inhalations) with Aerochamber Plus Spacer and Advair Diskus 100/50 twice daily. Protocol:  SAS105519. (2007).  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, MSN, ARNP

A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with facemask to subjects ages 6 months to 12.  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, MSN, ARNP.

A Randomized, Double-Blind, Placebo-Controlled Two-Treatment Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients with Cystic Fibrosis and Exocrine Pancreatic Insufficiency Protocol: EUR-1008-M.  (> 7 years of age). (2006-2007).  Principal Investigator: David Schaffer, MD.  Sub-Investigator:  Laurie Duckworth, MSN, ARNP.

An Open-Label Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) Microtabs in Pediactric Patients with Cystic Fibrosis and Exocrine Pancreatic Insufficiency Protocol: EUR-1009-M. (< 7 years of age) (2006-2007).  Principal Investigator: David Schaffer, MD.  Sub-Investigator:  Laurie Duckworth, MSN, ARNP

Sinusitis and Rhinitis in Asthma (SIRNA), American Lung Association, (2005-2006).  Principal Investigator:  John Lima, Pharm.D.  Sub-Investigator: Laurie Duckworth, MSN, ARNP

A Phase 3, Open-Label, Follow-on Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3). Protocol CP-AI-006 (2005-2006).  Principal Investigator: David Schaffer, MD.  Sub-Investigator:  Laurie Duckworth, MSN, ARNP.

The Leukotriene Modifier or Corticosteroids or Corticosteroid-Salmeterol Trial (The LOCCS Trial)  (2003-2005).  Principal Investigator:  John Lima, Pharm.D.  Sub-Investigator: Laurie Duckworth, MSN, ARNP.  

Polymorphisms of Nitric Oxide Synthase Genes in Sickle Cell Patients with Acute Chest Syndrome.  (2001-2004).  Principal Investigator:  John Lima PharmD.  Sub-Investigator:  Laurie Duckworth, ARNP, MSN.

A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder (TIP) Compared to TOBI® in Cystic Fibrosis (CF) Subjects. Protocol CTBM100C2302.  Principal Investigator: David Schaffer, MD.  Co-Investigator:  Laurie Duckworth, MSN, ARNP.

A Pilot Project Exploring the Feasibility of Using Remote Monitoring to PromoteTransition Readiness in Adolescents with Spina Bifida. Co-Investigator. NCCJ.  2008) Kim Jarczyk, MSN, ARNP.  

Physical and Mental Health Benefits of Dance in Visually Impaired Adolescents. Co-Investigator.  University of Florida College of Medicine. (2005-present) Kim Jarczyk, MSN, ARNP.

Development and initial use of the diabetes support in school scale, funded by Nemours Biomedical Research, May 2007.  Principal Investigator: Doreen Radjenovic, PhD, ARNP

Northeast Florida school nurse study, funded by the University of North Florida College of Health. May 2005.  Co-investigator: Doreen Radjenovic, PhD, ARNP.

Camp intervention for teens with type 2 diabetes, funded by the University of North Florida College of Health, May 2004.  Co-investigator: Doreen Radjenovic, PhD, ARNP.

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