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Park Nicollet Institute Annual Report 2003
  Innovating in Chronic Illness
  Letter from the President
  Highlights
  Recognition in Research and Education
  Research Studies
  Professional Education
  Publications
  Partners in Innovation
  Donors: Individual and Community
  Board of Directors
  Leadership Team
  Measures of Success

Research Studies

Administration

Project QUEST: Organizational Factors and Quality of Chronic Disease Care
Principal Investigator: Patrick O'Connor, MD, MPH, HealthPartners Research Foundation
Sponsor: Agency for Healthcare Research and Quality


Asthma and Allergy

A Multicenter, Multinational, Randomized, Double-Blind, Parallel-Group Study of the Effects of a Study Drug and Beclomethasone on Lens Opacification in Adult Subjects with Moderate to Severe Persistent Asthma
Principal Investigator:  Richard Sveum, MD
Sponsor: AstraZeneca

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of a Study Drug in Patients with Perennial Allergic Rhinitis
Principal Investigator: Richard Sveum, MD
Sponsor: Merck & Co. Inc.

A Two-Staged Randomized, Open-Label, Parallel Group, Phase III, Multicenter, Seven-Month Study to Assess the Efficacy and Safety of a Study Drug Administered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair™ in Subjects 12 Years of Age and Older with Asthma
Principal Investigator:  Richard Wyatt, MD
Sponsor: AstraZeneca

A 52-Week, Randomized, Double-Blind, Single-Dummy, Parallel-Group, Multicenter Phase III Study Comparing the Long-Term Safety of a Study Drug X 4 Actuations Twice Daily to the Same Study Drug X 2 Actuations Twice Daily and Budesonide X 4 Actuations Twice Daily in Adult and Adolescent Subjects with Asthma
Principal Investigator: Pamela Harris, MD
Sponsor: AstraZeneca

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of a Study Drug in Patients with Seasonal Allergic Rhinitis – A Pilot Study During the Fall Season
Principal Investigator: Richard Sveum, MD
Sponsor: Merck & Co. Inc.

A 24-Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Study Drug (250 mcg. or 500 mcg.) Daily in Patients with Asthma
Principal Investigator: William Schoenwetter, MD
Sponsor: Pharmacia

Long-Term Safety Study of a Study Nasal Spray
Principal Investigator: David Graft, MD
Sponsor: Alcon Research Ltd.

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Trial with a Study Solution for Inhalation in Mild to Moderate Asthma Patients
Principal Investigator: Pamela Harris, MD
Sponsor: Abaris Pharma Inc.

A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of a Study Drug on Allergic Rhinitis in Patients with Seasonal Allergic Rhinitis and Chronic Asthma
Principal Investigator: Pamela Harris, MD
Sponsor: Merck & Co. Inc.

A Randomized, Double-Blind, Placebo-Controlled Trial of a Study Nasal Spray at a Dosage of One Spray per Nostril Twice Daily in Patients with Seasonal Allergic Rhinitis
Principal Investigator: William Schoenwetter, MD
Sponsor: MedPointe Healthcare

A 12-Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of a Study Drug Administered Once Daily in Children and Adolescents 6 to 15 Years of Age with Asthma (SPROUT)
Principal Investigator: Richard Wyatt, MD
Sponsor: AstraZeneca

Phase II, Randomized, Blinded, Placebo-Controlled, Multiple-Dose, Dose-Finding Study to Evaluate the Safety and Clinical Activity of a Study Drug in Patients with Ragweed-Induced Seasonal Allergic Rhinitis
Principal Investigator: William Schoenwetter, MD
Sponsor: IDEC Pharmaceuticals Corporation

A Multicenter, Double-Blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Investigational Doses of a Study Drug and Placebo in Subjects with Perennial Allergic Rhinitis
Principal Investigator: Richard Sveum, MD
Sponsor: Aventis Pharmaceuticals

A 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of a Combination Study Drug Versus its Mono-Products in Children (>6 years of age) and Adults with Asthma
Principal Investigator: Pamela Harris, MD
Sponsor: AstraZeneca

A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of a Powder Combination of a Study Drug and an Inhaled Study Drug in Symptomatic Pediatric Subjects (4-11 Years) with Asthma
Principal Investigator: Richard Wyatt, MD
Sponsor:  GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Efficacy and Safety of a Powder Combination of a Study Drug and an Inhaled Study Drug in Symptomatic Adolescent and Adult Subjects with Asthma that is not Controlled on Short-Acting Beta2 Agonists Alone
Principal Investigator:  Pamela Harris, MD
Sponsor: GlaxoSmithKline

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A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 16-Week Comparison of Asthma Control in Adolescents and Adults Receiving an Approved Combination Inhaler for Four Weeks, Then Switching to One of Four Therapies
Principal Investigator:  William Schoenwetter
Sponsor: GlaxoSmithKline

A Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study of Four Months Duration per Subject to Evaluate the Safety and Efficacy of a Study Drug in Adolescent and Adult Subjects with Persistent Stable Asthma
Principal Investigator: David Graft, MD
Sponsor: Novartis Pharmaceuticals Corporation

A Multicenter, Open-Label, Randomized, Parallel Group Study to Assess the Long-Term Safety Performance of a Medication Currently Approved for Treating SAR Compared to a Medication Currently Approved for Long-Term Treatment of Asthma in Subjects with Asthma
Principal Investigator:  William Schoenwetter, MD
Sponsor: Aventis Pharmaceuticals

A Multicenter, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of a Medication, Currently Approved for Treating SAR, in Subjects with Mild to Moderate Persistent Asthma
Principal Investigator:  Richard Sveum, MD
Sponsor: Aventis Pharmaceuticals

A Phase IIIa, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study on the Efficacy and Safety of a Study Drug in Chronic Idiopathic Urticaria
Principal Investigator: Richard Wyatt, MD
Sponsor: Aventis Pharmaceuticals


Cardiology

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Efficacy and Safety of a Study Drug in Subjects Hospitalized with Worsening Congestive Heart Failure
Principal Investigator: Thomas Suh, MD
Sponsor: Otsuka Maryland Research Institute Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Pilot Study Evaluating the Efficacy and Safety of a Study Drug in Patients with Decompensated Chronic Heart Failure 
Principal Investigator: Thomas Suh, MD
Sponsor: Yamanouchi Pharma America Inc.

Registry of Cardiac Resynchronization Therapy-US (RESTORE-US)
Principal Investigator: Richard Madlon-Kay, MD
Sponsor: Medtronic Inc.

A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of a Study Drug Compared with Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention (JUMBO-TIMI 26)
Principal Investigator: J. Mark Haugland, MD
Sponsor: Eli Lilly and Company

Efficacy and Safety of a New Oral Direct Thrombin Inhibitor Compared with Dose Adjusted Warfarin (Coumadin) in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation (SPORTIF V)
Principal Investigator: J. Mark Haugland, MD
Sponsor: AstraZeneca

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Pravastatin or Atorvastatin Evaluation and Infectious Therapy (PROVE IT)
Principal Investigators: Gary Cramer, MD, and Thomas Davis, MD
Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute

Pain Free Rx II (Does Pacing Fast VT Reduce Shock Rx?)
Principal Investigator: J. Mark Haugland, MD
Sponsor: Medtronic Inc.


Cardiothoracic Surgery

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Study Drug-Device Combination in the Treatment of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures
Principal Investigator: Ted Spooner, MD
Sponsor: Corgentech


Eating Disorders Institute

Anna Westin House Residential Outcomes Study
Principal Investigator: Jillian Croll, PhD, RD, MPH  
Sponsor: Blue Cross/Blue Shield of Minnesota Foundation

The Cost of Bulimia Nervosa
Principal Investigator: Scott Crow, MD
Sponsor: University of Minnesota and the Eating Disorders Institute

The Effect of an Oral Contraceptive on Bone Mineral Density in Pediatric Subjects with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
Principal Investigator: Scott Crow, MD
Sponsor: Ortho-McNeil Pharmaceutical Inc.

Assessing the Management of Eating Disorders in Family Practice
Principal Investigator: Jillian Croll, PhD, RD, MPH
Sponsors: Park Nicollet Institute and Park Nicollet Foundation

Eating Disorders Stage of Change: Reliability and Validity of a New Measure
Principal Investigator: Diann Ackard, PhD, LP
Sponsor: Park Nicollet Institute


Family Practice

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Attack Study to Evaluate the Onset of Efficacy of a New Formulation of a Study Drug in the Acute Treatment of Migraine
Principal Investigator: John Robrock, MD
Sponsor: GlaxoSmithKline


Health Information Management

Minnesota Heart Survey
Principal Investigator: Catherine Borbas, PhD, MPH, Healthcare Education and Research Foundation
Sponsor: National Heart, Lung, and Blood Institute

Atherosclerosis Risk in Communities (ARIC) Study
Principal Investigator: Aaron Folsom, MD, University of Minnesota
Sponsor: National Heart, Lung, and Blood Institute

Community Surveillance of Congestive Heart Failure
Principal Investigator: Eyal Sharer, MD, PhD, University of Minnesota
Sponsor: National Heart, Lung, and Blood Institute

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Improving Utilization of Ischemic Stroke Research
Principal Investigator: Catherine Borbas, PhD, MPH, Healthcare Education and Research Foundation Inc.
Sponsor: Agency for Healthcare Research and Quality


Health Research Center

Vaccine Safety Data Link Project
Principal Investigator: Michael Goodman, PhD, HealthPartners Foundation
Local Principal Investigator: Renner Anderson, MD
Sponsor: Centers for Disease Control and Prevention

A National Center for Value Purchasing Methods (1758-03)
Principal Investigators: Michael Callahan, HealthFront, and David Knutson
Sponsor: Agency for Healthcare Research and Quality

Weight Management, Physical Activity, Less Disability in Rheumatoid and Osteoarthritis
Principal Investigator: Barbara Braun, PhD
Sponsor: Centers for Disease Control and Prevention

Impact of Secure Messaging on the COMPASS Program
Principal Investigators: Allan Kind, MD, and Jinnet Fowles, PhD
Sponsor: Tonkawa Inc.

Lyme025—A Cohort Study:  Safety Reporting on Participants Receiving Lyme Vaccine (Post Marketing Surveillance)
Principal Investigator: Peter Harper, MD, HealthPartners Research Foundation
Sponsor: GlaxoSmithKline

Colon Cancer Survivors: Medication and Risk of Recurrence
Principal Investigator: Sharon Rolnick, PhD, HealthPartners Research Foundation
Sponsor: National Cancer Institute

Cancer Surveillance in HMO Administrative Data
Principal Investigator: Feifei Wei, PhD, HealthPartners Research Foundation
Sponsor: National Cancer Institute

Women’s Perception of Cardiovascular Disease Risk
Principal Investigator: David Homans, MD
Sponsor: Park Nicollet Institute

Purchaser/Provider Evaluation: Hospital Quality Data, TN
Principal Investigator: Barbara Braun, PhD
Sponsor: Agency for Healthcare Research and Quality

Which Patients Want to Examine Their Medical Record?
Principal Investigator: Jinnet Fowles, PhD
Sponsor: Tonkawa Inc.


Park Nicollet HealthSource

Healthy Young Workers Project: A Demonstration Project to Implement and Evaluate Promising Policy Change Initiatives with 18-24 Year-Olds
Principal Investigator: Ted Wegleitner
Sponsor: Minnesota Partnership for Action Against Tobacco


Infectious Disease

A Randomized, Double-Blind, Controlled Dose Finding Study of a Study Drug for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy
Principal Investigator: Harold Martin, MD
Sponsor: NeurogesX Inc.

A Randomized, Prospective, Pilot Study of Adherence Monitoring and Intervention in HIV-Infected Patients Receiving a Kaletra-Based HRRT Regimen
Principal Investigator:  Leslie Baken, MD
Sponsor: Abbott Laboratories Inc.

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A Phase III, Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of a Study Drug in Combination with an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients with Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
Principal Investigator: Harold Martin, MD
Sponsors: Hoffman-La Roche Inc. and Trimeris Inc.

An Open-Label Study Assessing the Safety and Tolerability of Chronic Dosing with a Study Drug in HIV Positive Subjects Who Have Failed Therapy with a Fusion Inhibitor Containing Regimen
Principal Investigator: Harold Martin, MD
Sponsor: Trimeris Inc.


International Diabetes Center

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study of the Safety of a Study Drug in the Treatment of Patients with Type 2 Diabetes Mellitus
Principal Investigator: David Kendall, MD
Sponsor: Takeda Pharmaceuticals America Inc.

Outcomes of Dual Therapy with Rosiglitazone and Metformin Compared to Sulfonylurea and Metformin for Treatment of Type 2 Diabetes: A Non-Randomized, Parallel-Groups Study Based on Retrospective Medical Record Review
Principal Investigator: Gregory Damberg, MD
Sponsor: GlaxoSmithKline

Long-Term Effects of Insulin plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients with Type 2 Diabetes: A Comparison of Pre-Meal Insulin Lispro Mixtures to Once-Daily Insulin Glargine
Principal Investigator:  Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

Field Evaluation of User Performance for a Blood Glucose Monitoring System
Principal Investigator: Richard Bergenstal, MD
Sponsor: Abbott Laboratories

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of a Study Drug 9 mg. and 30 mg. in Patients with Diabetic Polyneuropathy
Principal Investigator: Richard Bergenstal, MD
Sponsor: Sankyo Pharma Development

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Study Drug Added to Insulin in Patients with Adequately Controlled Type 2 Diabetes Mellitus
Principal Investigator: David Kendall, MD
Sponsor: Merck & Co. Inc.

A Study Drug versus Placebo in the Treatment of Patients with Painful Diabetic Neuropathy
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

The Efficacy and Safety of a Study Drug for the Treatment of Type 2 Diabetes
Principal Investigator: David Kendall, MD
and
A Non-Drug Study to Follow Patients Who Participated in the Previous Study
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

A Multicenter, International, Randomized Study to Evaluate the Effects of Insulin Glargine Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High-Risk People with Impaired Fasting Glucose, Impaired Glucose Tolerance or Early Type 2 Diabetes Mellitus
The Origin Trial (Outcome Reduction with Initial Glargine Intervention)
Principal Investigator: David Kendall, MD
Sponsor: Aventis Pharmaceuticals

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A Multicenter, Double-Blind Study to Evaluate the Effect of Pre-Treatment with a Daily Dose of Study Drug on the PRN Efficacy of the Study Drug in Men with Erectile Dysfunction and Type 2 Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: Pfizer Inc.

Worksite Diabetes Management: Partnering for Success
Principal Investigator: Richard Bergenstal, MD
Sponsor: Park Nicollet Foundation

Intensive Care Unit Glucose Control Study 
Principal Investigator: Lisa Fish, MD
Sponsor: Park Nicollet Foundation

Admission Glucose ICU Study
Principal Investigator: Lisa Fish, MD
Sponsor: Park Nicollet Institute

Prevalence of Peripheral Neuropathy in Type 1 and Type 2 Diabetes: Coexistence with Other Diabetic Microvascular Complications
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

Partners in Advancing Care and Education Solutions
Principal Investigator: Roger Mazze, PhD
Sponsor: Novartis Pharmaceuticals Corporation

The Effect a Study Drug on Albuminuria in Patients with Type 2 Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

A Study Drug Treatment of Peripheral Neuropathy in Patients with Diabetes: A Phase III Pivotal Trial
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

A Study Drug for Symptomatic Peripheral Neuropathy in Patients with Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

Evaluation of Interstitial Fluid Glucose Monitoring with the TheraSense Continuous Monitoring System
Principal Investigator: David Kendall, MD
Sponsor: TheraSense Inc.

An Open-Label Extension Study of Protocol 2993-115 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of a Study Drug Given Two Times a Day to Subjects Treated with Metformin and a Sulfonylurea
Principal Investigator: David Kendall, MD
Sponsor: Amylin

Morning Long-Acting Insulin Versus Intermediate-Acting Insulin Twice Daily as Basal Insulin in a Multiple Daily Injection Regimen with Rapid-Acting Insulin in Adolescents with Type 1 Diabetes Mellitus: An Active-Controlled, Open, Randomized, Gender-Stratified, Two-Arm, Parallel-Group Study
Principal Investigator: Martha Spencer, MD
Sponsor: Aventis Pharmaceuticals

Efficacy and Safety of a New Insulin Compared to Placebo in Patients with Type 2 Diabetes Mellitus Following Diabetes Education
Principal Investigator: Richard Bergenstal, MD
Sponsor: MannKind Corporation

Driving Safety and Diabetes
Principal Investigator: Roger Mazze, PhD
Sponsor: National Institutes of Health

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The ANSWER Program: The Norditropin National Registry Program
Principal Investigator: Martha Spencer, MD
Sponsor: PharmaMar

Basal/Bolus Therapy with Rapid-Acting Insulin Versus Short-Acting Insulin, or Rapid-Acting Insulin in Combination with Intermediate-Acting Insulin: Open-Label, Randomized, Parallel-Group, Multicenter Study in Children and Adolescents with Type 1 Diabetes
Principal Investigator: Martha Spencer, MD
Sponsor: Novo Nordisk Pharmaceuticals Inc.

A Study Drug in Type 2 Hypertriglyceridemic Diabetic Subjects: A 26-Week Double-Blind, Multicenter, Randomized, Parallel, Active-Controlled Study to Investigate Safety and Efficacy
Principal Investigator: Gregory Damberg, MD
Sponsor: Novo Nordisk Pharmaceuticals Inc.

Central Obesity and Elevated Albumin Excretion in Type 1 Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: National Institutes of Health

Diabetes Coaching at the Worksite
Principal Investigator: Lorraine Schafer, PhD
Sponsor: Park Nicollet Foundation and Park Nicollet Institute

Collaborative Care Model for Diabetes in the School Setting
and
Substudy: Depression Screening for Children and Adolescents at a Collaborative Clinic/School Health Fair
Principal Investigator: Lorraine Schafer, PhD, LP
Sponsor: Park Nicollet Foundation

Smoking Cessation in Adults with Type 2 Diabetes
Principal Investigator: David Kendall, MD
Sponsor: Minnesota Partnership for Action Against Tobacco

A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Compared to Metformin or Glyburide/Glibenclamide in Patients with Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus (<2 Years)
Principal Investigator: Gregory Damberg, MD
Sponsor: GlaxoSmithKline

Concentration Control Trial of Norditropin® SimpleXx™ in Children with Growth Hormone Deficiency: A Two-Year, Open-Label, Randomized, Multicenter Trial
Principal Investigator: Martha Spencer, MD
Sponsor: Novo Nordisk Pharmaceuticals Inc.

Comparison of Two Study Drugs in Subjects with Type 2 Diabetes Mellitus and Dyslipidemia
Principal Investigator: David Kendall, MD
Sponsor: Eli Lilly and Company

Action to Control Cardiovascular Risk in Diabetes (ACCORD)
and
Action to Control Cardiovascular Risk in Diabetes:
· Memory in Diabetes Substudy
· Ancillary Eye Study
Principal Investigator: David Kendall, MD
Sponsor: National Institutes of Health

The DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) Trial
Principal Investigator: Richard Bergenstal, MD
Sponsors: Canadian Institutes of Health Research, Aventis Pharmaceuticals, King Pharmaceuticals and GlaxoSmithKline

Genetic Studies of Diabetic Complications in Epidemiology of Diabetes Interventions and Complications
Principal Investigator: Richard Bergenstal, MD
Sponsor: National Institutes of Health

A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Two Study Drugs in Hypertensive Patients with Type 2 Diabetes Mellitus
Principal Investigator: C. Rowan DeBold, MD
Sponsor: GlaxoSmithKline

Evaluation of the Dose-Response Relationship of a Study Drug on Fasting and Postprandial Blood Glucose and Tolerability in Patients with Type 2 Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: Eli Lilly and Company

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Field Evaluation of a New Blood Glucose Monitoring System: Accuracy, Lay-User Acceptability and Precision
Principal Investigator: Richard Bergenstal, MD
Sponsor: Abbott Laboratories Inc.

Program Evaluation: Measuring the Effectiveness of Intensive Insulin Therapy through Multiple Daily Injections and a Continuous Subcutaneous Insulin Infusion Diabetes Management Program (AIM)
Principal Investigator: Lisa Fish, MD
Sponsors: Disetronic Medical Systems Inc., Eli Lilly and Company and Roche Diagnostics


Internal Medicine

A Prospective, Multinational, Multicenter, Double-blind, Randomized, Active-Controlled Trial to Compare the Effects of a Study Drug to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients with High Risk Hypertension (ACCOMPLISH)
Principal Investigator:  Anthony Woolley, MD
Sponsor: Novartis Pharmaceuticals


Neurology

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Attack Study to Evaluate the Onset of Efficacy of a New Formulation of a Study Drug in the Acute Treatment of Migraine
Principal Investigator: Frederick Taylor, MD
Sponsor: GlaxoSmithKline

The Safety and Efficacy of an Extended Release Study Drug in Migraine Prophylaxis: A Double-Blind, Placebo-Controlled Study in Adolescents
Principal Investigator: Frederick Taylor, MD
Sponsor: Abbott Laboratories Inc.

Carotid Occlusion Surgery Study
Principal Investigator: Sandra Hanson, MD
Sponsor: National Institute of Neurological Disorders and Stroke 

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Tolerability of an Oral Medication for a Single, Moderate or Severe Headache in Adults Diagnosed with Migrainous Disorder
Principal Investigator: Frederick Taylor, MD
Sponsor: GlaxoSmithKline

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial to Evaluate Early Efficacy and Tolerability of a Study Nasal Spray in the Acute Treatment of Adult Subjects With Migraine
Principal Investigator: Frederick Taylor, MD
Sponsor: AstraZeneca LP


Obstetrics and Gynecology

Essure™ System United States Post-Approval Study for Newly Trained Physicians
Principal Investigator: Deborah Thorp, MD
Sponsor: Conceptus Inc

Efficacy and Safety of a Study Drug Compared with Placebo in Women with Symptoms of Mixed Urinary Incontinence: Protocol 
Principal Investigator: Michael Valley, MD
Sponsor: Eli Lilly and Company

Helicobacter Pylori Infection and Hyperemesis Gracidarum in Women from Somalia
Principal Investigator: Susan Feron, MD, University of Minnesota
Sponsor: University of Minnesota


Nursing Administration

A Model of Patient and Nursing Administration Outcomes
Principal Investigator: Barbara Mark, PhD, University of North Carolina
Sponsor: National Institute for Nursing Research


Occupational Health/Park Nicollet HealthSource

Effectiveness of a Machine Guarding Intervention
Principal Investigator: David Parker, MD
Sponsor: Centers for Disease Control and Prevention

Work Wise: A School-Based Agricultural Intervention
Principal Investigator: David Parker, MD
Sponsor: National Institute for Occupational Safety and Health

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Oncology Research

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Study Drug Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Principal Investigator: Martin Lee, MD
Sponsor: GlaxoSmithKline

An Open-Label, Randomized, Phase III Study of Intermittent Oral Study Drug in Combination with Intravenous Study Drug Versus Bolus and Continuous Infusion Leucovorin with Intravenous Oxaliplatin as First-Line Treatment for Patients with Metastatic Colorectal Cancer and Accompanying Sample Repository Research Project
Principal Investigator: Martin Lee, MD
Sponsor: Hoffman-La Roche

An Open-Label, Randomized, Phase III Study of Intermittent Oral Study Drug in Combination with an Intravenous Study Drug Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C) and Roche Sample Repository Research Project (RSR) for Use in Conjunction with this Study
Principal Investigator: Martin Lee, MD
Sponsor: Hoffman-La Roche

The Effects of Zolendronic Acid (Zometra™) and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer
Principal Investigator: Karen Swenson, RN, MS, AOCN
Sponsor: Novartis Pharmaceuticals Corporation

Predictors of Lymphedema Following Breast Cancer Surgery
Principal Investigator: Karen Swenson, RN, MS
Sponsor: US Army Medical Research

A Study to Assess Symptom Burden in Subjects with Nonmyeloid Malignancies Receiving Chemotherapy and a Study Drug
Principal Investigator: Martin Lee, MD
Sponsor: Amgen

A Phase I Dose-Escalation Study of Thrice-Weekly Study Drug in Combination with Trastuzumab in Subjects with HER-2/neu Positive Metastatic Breast Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Chiron Therapeutics

A Multicenter, Open-Label Trial to Evaluate the Efficacy and Safety of a Study Drug of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma
Principal Investigator: Martin Lee, MD
Sponsor: IDEC Pharmaceuticals Corporation

A Randomized, Open-Label, Multicenter Study of Primary Prophylaxis with a Study Drug Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (65 Years Old) with Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Amgen

Dietary Intake in Women with Breast Cancer: Study 1: Comparison to National Data Sets; Study 2: Predictors to Adherence to a Low-Fat Diet Intervention
Principal Investigator: Alice Shapiro, PhD, RD, LN
Sponsor: Park Nicollet Institute

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women with Clinical Stage T1 or T2 Breast Cancer
Principal Investigator: Joel Friedman, MD
Sponsor: American College of Surgeons

A Randomized Trial of Axillary Node Dissection in Women With Clinical Stage T1 or T2 N0M Breast Cancer Who Have a Positive Sentinel Node
Principal Investigator: Joel Friedman, MD
Sponsor: American College of Surgeons

Breast Cancer Risk Factors and Diagnostic Mammogram Sensitivity Among Women Diagnosed with Breast Cancer in their Forties
Principal Investigator: Carol McPherson, MSW, MPH
Sponsor: Park Nicollet Institute

Breast Cancer Adjuvant Educational Program (BCAEP): A Randomized Clinical Trial of a Computer-Based Learning Tool to Aid in Decision-Making Concerning Adjuvant Therapy for Early Breast Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Park Nicollet Institute

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A Multicenter Clinical Trial to Determine the Efficacy of a Dietary Fat Reduction Program Provided in Addition to Systemic Adjuvant Therapy in the Management of Patients with Primary Invasive Breast Cancer
Principal Investigator: Alice Shapiro, PhD
Sponsor: American Health Foundation

Sunbelt Melanoma Trial (SMT): A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients with Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy
Principal Investigator: Keith Heaton, MD
Sponsor: Schering Corporation

A Prospective Study to Compare Side Effects and Functional Status by Treatment Type for Early Stage Prostate Cancer
Principal Investigator: Carol McPherson, MSW, MPH
Sponsor: Nycomed-Amersham

An Expanded Access Clinical Program with a Study Drug for Patients with Advanced Non-Small Cell Lung Cancer
Principal Investigator: Joseph Leach, MD
Sponsor: AstraZeneca LP

Study Drug in an Alternative Dose (ILIAD Trial): Treatment of Patients with Metastatic Renal Cell Carcinoma with Low-Dose Proleukin
Principal Investigator: Martin Lee, MD
Sponsor: Chiron Corporation
 
Phase I/II Clinical Trial of a Combination of Weekly Vinorelbine and Weekly Carboplatin in Advanced Non-Small Cell Lung Cancer
Principal Investigator: Martin Lee, MD
Sponosr: GlaxoSmithKline

A Pilot Study of a Combination of Mitoxantrone, Estramustine, Weekly Paclitaxel (Taxol) and Hydrocortisone (METH) for the Treatment of Hormone-Resistant Prostate Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Bristol-Myers Squibb Company

An Open-Label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy and Study Drug
Principal Investigator: Martin Lee, MD
Sponsor: Amgen


Oncology Research/Surgery

Intraoperative Subareolar Injection of Technetium-99 for Breast Sentinel Lymph Node Identification
Principal Investigator: Joel Friedman, MD
Sponsor: Park Nicollet Institute


Orthopedic Center

Evaluation of BioCleanse™ Patellar Tendon Allografts for the Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
Principal Investigator: Joel Boyd, MD
Sponsor: Regeneration Technologies

Shoulder Prosthesis Study
Principal Investigator: Carlos Guanche, MD
Sponsor: Encore Medical LP


Orthopedics

Double-Blind, Randomized, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of a Study Drug on the Rate of Healing in Distal Radius Fractures
Principal Investigator: Benjamin Levine, MD
Sponsor: OrthoLogic

Pathology

Rapid Diagnosis of Malaria with Antigen Capture Compared to Smear and PCR in Symptomatic Patients in Minnesota
Principal Investigator:  Susan Bowers, MD
Sponsors: Park Nicollet Pathology and Minnesota Department of Health


Pediatric Endocrinology

Human Growth Hormone in Children with Growth Failure Associated with Insulin-like Growth Factor Deficiency: A 12-Month, Open-Label, Randomized, Parallel Group Study
Principal Investigator: Martha Spencer, MD
Sponsor: Novo Nordisk Pharmaceuticals, Inc.

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Pediatrics

Synagis Outcomes Registry
Principal Investigator: Andrew Rzepka, MD
Sponsor: MedImmune Inc.


Podiatric Medicine

Enclavement Procedure for Painful Hallux Limitus
Principal Investigators: Stephen Powless, DPM,  and Greg Brockbank, DPM
Sponsor: Department of Podiatry


Radiology

Computer Aided Detection of Mammograms
Principal Investigator: Michael T. Nelson, MD
Sponsor: ICAD Inc.

Computer Aided Detection of Full Field Digital Mammography Cases
Principal Investigator: Michael T. Nelson, MD
Sponsor: R2 Technology


Rheumatology Treatment and Resource Center

A Phase III Multicenter Study of the Safety and Efficacy of a Study Drug in Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy and a Continuation Trial
Principal Investigator: Robert Tierney, MD
Sponsor:  Abbott Laboratories Inc.

A Randomized, Multi-Factorial, Double-Blind, Parallel-Group, Dose-Ranging Study of the Efficacy and Safety of a Study Drug in Combination with Methotrexate in Patients with Rheumatoid Arthritis
Principal Investigator:  Robert Tierney, MD
Sponsors: Hoffman-La Roche and Genentech Inc.

Randomized, Multicenter, Parallel-Group Study to Determine if Knowledge of Baseline Vertebral Fracture Prevalence (as Determined by Hologic IVA) and Bone Turnover Marker Levels Improves Persistence with Study Drug. Daily Therapy in Subjects Receiving Chronic Glucocorticoid Therapy
Principal Investigator: John Schousboe, MD
Sponsor: Aventis Pharmaceuticals

Comparison of the Effects of Two Individual Study Drugs on Lumbar Spine Bone Mineral Density in Glucocorteroid-Induced Osteoporosis
Principal Investigator: John Schousboe, MD
Sponsor: Eli Lilly and Company

A Phase III, Randomized, Multicenter Study Comparing the Safety and Efficacy of a Study Drug Versus Allopurinol in Subjects with Gout
Principal Investigator: Scott Glickstein, MD
Sponsor: TAP Pharmaceuticals

BioMarkers for Anti-TNF Response in Rheumatoid Arthritis
Principal Investigator: Eric Schned, MD
Sponsor: National Institutes of Health

A Study of the Agreement between the Standard and Modified ACR Improvement Criteria in Rheumatoid Arthritis Subjects Receiving Study Drug After Having an Unsatisfactory Response to Disease-Modifying Anti-Rheumatic Drug Therapy (DMARDS) or Study Drug Outcome Measurements Evaluation with Treatment
Principal Investigator: Robert Tierney, MD
Sponsor: Amgen

Accuracy of Lateral X-ray Absorptiometry to Detect Vertebral Compression Fracture Deformities Compared to Standard Radiography, and Impact of their Detection on Therapy to Prevent Osteoporotic Fracture
Principal Investigator: John Schousboe, MD
Sponsor: Hologic and Park Nicollet Institute

Osteoporosis Education and Screening in the Community: Effect on Health Care Behavior with Respect to Preventing Osteoporosis in Employed Populations
Principal Investigator: John Schousboe, MD
Sponsor: Park Nicollet Foundation

SONORA: Study of New-Onset Rheumatoid Arthritis
Principal Investigator: Robert Tierney, MD
Sponsor: Abbott Laboratories Inc.

Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
Principal Investigator: John Schousboe, MD
Sponsor: Rheumatoid Arthritis Investigational Network

Can Patients Self-Select Themselves for Bone Densitometry? Utility of the Osteoporosis Risk Assessment Instrument (ORAI) Mailed to Women Age 45 and Older
Principal Investigator: John Schousboe, MD
Sponsor: Park Nicollet Foundation

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Treatment of Early Rheumatoid Arthritis: Minocycline in Combination with Methotrexate Versus Methotrexate Alone
Principal Investigator: John Schousboe, MD
Sponsor: Rheumatoid Arthritis Investigational Network

Triple III: Comparison of Leflunomide Alone Versus Two Disease-Modifying Anti-Rheumatic Drug (DMARD) Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis
Principal Investigator: John Schousboe, MD
Sponsor: Rheumatoid Arthritis Investigational Network

An International, Multicenter, Stratified, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 52-Week Gastrointestinal Clinical Safety Study to Demonstrate that a New COX II Inhibitor Reduces the Risk to Develop Complicated Ulcers as Compared to Naproxen (500mg. BID), in Rheumatoid Arthritis and Osteoarthritis Patients
Principal Investigator: John Schousboe, MD
Sponsor: Novartis Pharmaceuticals Corporation


Sexual Health

An Open-Label Study to Evaluate the Efficacy and Safety of a Study Drug Administered “On Demand” to Men of Various Populations with Erectile Dysfunction
Principal Investigator: William Borkon, MD
Sponsor: Eli Lilly and Company

A Multicenter, Open Label, Flexible Dose Study to Investigate the Use Patterns of a Study Drug and the Ability of Investigators to Further Optimize Subject Satisfaction with that Study Drug Through Customized  Instruction
Principal Investigator: William Borkon, MD
Sponsor: Pfizer Inc.


Struthers Parkinson's Center

A Multicenter, Double-Blind, Pilot Study of Two Study Drugs in Subjects with Early Untreated Parkinson’s Disease
Principal Investigator: Martha Nance, MD
Sponsor: National Institute for Neurological Disorders and Stroke

A Multicenter, Family-Based Study of Genetic Determinants of Parkinson’s Disease
Principal Investigator: Martha Nance, MD
Sponsor: GlaxoSmithKline

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of a Study Drug as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa/Carbidopa Therapy
Principal Investigator: Sotirios Parashos, MD
Sponsor: Kyowa Pharmaceuticals

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A Long-Term, Multicenter, Open-Label Safety Study with a Flexible-Dose Range of a Study Drug as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa/Carbidopa Therapy
Principal Investigator: Sotirios Parashos, MD
Sponsor: Kyowa Pharmaceuticals

A Prospective, Randomized, Placebo-Controlled, Parallel-Group Study of the Continued Efficacy and Safety of Subcutaneous Injections of a Study Drug in the Treatment of "Off" Episodes in Patients with "On/Off" or "Wearing-Off" Effects Associated with Late-Stage Parkinson's Disease after Apomorphine Use for at least a Three-Month Duration
Principal Investigator: Martha Nance, MD
Sponsor: Mylan Pharmaceuticals

Optimizing Therapeutic Outcome with Comtan in Parkinson’s Disease Patients
Principal Investigator: Catherine Wielinski, MPH
Sponsor: Novartis Pharmaceuticals Corporation

Plasma Half-Life of Levodopa after Administration of Additional Carbidopa in PD Patients Already Treated with a Combination of Carbidopa/Levodopa and Entacapone
Principal Investigator: Sotirios Parashos, MD
Sponsor: Struthers Parkinson’s Center


Vascular Surgery

A Comparative, Prospective, Randomized, Double-Masked, Parallel Group, Controlled Trial of a Study Therapy Versus Sham Control When Added to Standard Care in the Treatment of Diabetic Neuropathic Ulcers
Principal Investigator: M. Mark Melin, MD
Sponsor: Celleration

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