Placebo Controlled Efficacy and Safety Study with Long-Term Safety Evaluation of an Inhaled Corticosteroid given via an Metered Dose Inhaler in Reducing Oral Prednisone Requirements in Subjects with Severe Asthma
Principal Investigator: David Graft, MD
Sponsor: Schering-Plough Research Institute

Treatment of Asthma in Children Previously Maintained on Inhaled Corticosteroids
Principal Investigator: David Graft, MD
Sponsor: Schering-Plough Research Institute

One-Year, Open-Label Safety Study of a New Inhaled Corticosteroid  and Another Inhaled Corticostoid in Children with Asthma Previously Maintained on Inhaled Corticosteroids
Principal Investigator: David Graft, MD
Sponsor: Schering-Plough Research Institute

A Randomized, Double-Blind, Multicenter Study to Evaluate the Effect of Adding Either a Leukotriene-Receptor Antagonist or a Long-acting Beta Agonist to an Inhaled Corticosteriod in Adult Asthmatics 
Principal Investigator: David Graft, MD
Sponsor: Merck & Co., Inc.

Efficacy and Safety of a New Antihistamine in the Treatment of Patients with Chronic Idiopathic Urticaria
Principal Investigator: David Graft, MD
Sponsor: Schering-Plough Research Institute

Placebo-Controlled Efficacy and Safety Study of a New Inhaled Corticosteroid in the Treatment of Asthma in Children Previously Maintained on Inhaled Corticosteroids
Principal Investigator: David Graft, MD
Sponsor: Schering-Plough Research Institute

A Randomized, Open-Label Study Evaluating Measures of Pharmacoeconomics, Efficacy, and Safety in Patients Using the Combination of a Long-Acting Beta Agonist and an Inhaled Corticosteroid Multi-Dose Powdered Inhaler Compared to Multi-Controller Therapy for the Treatment of Persistent Asthma within a Managed Care Environment
Principal Investigator: Richard Morris, MD
Sponsor: Glaxo Wellcome Inc.

A Study to Compare the Safety and Efficacy of an Anti-Ulcer Medication BID Versus Placebo in Patients with Asthma Associated with Symptomatic Gastroesophageal Reflux (GER)
Principal Investigator: Richard Morris, MD
Sponsor: TAP Holdings, Inc.

A Randomized, Double-blind Study to Compare the Efficacy and Safety of Two Inhaled Corticosteroids and Placebo in the Treatment of Asthma in Patients Previously Maintained on Inhaled Corticosteroids   
Principal Investigator: Richard Morris, MD
Sponsor: Integrated Therapeutics Group

Safety and Efficacy Study of an HFA Bronchodilator Delivered from a Press-and-Breathe MDI, an HFA Bronchodilator Delivered from the Autohaler™ Inhalation Device, and HFA-Placebo in Patients with Asthma   
Principal Investigator: Richard Morris, MD
Sponsor: 3M Pharmaceuticals

The Cost Effectiveness (Comparison) of Two Inhaled Corticosteroids in Adult Patients With Asthma
Principal Investigator: William Schoenwetter, MD
Sponsor: Aventis Pharmaceuticals, Inc.

Randomized, Parallel-Group, Open-Label Multicenter Clinical Study Comparing the Safety, Efficacy, Quality of Life and Socioeconomic Variables of Twice Daily Administration of a New Long-Acting Bronchodilator to Twice Daily Administration of Another Long-Acting Bronchodilator Administered for Six Months to Adult Subjects with Reversible Obstructive Airway Disease (ROAD)
Principal Investigator: William Schoenwetter, MD
Sponsor: Novartis Pharmaceuticals

A Phase IIIB, Multicenter, Multiple Dose, 4-Month, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of an Anti-IgE Recombinant Humanized Monoclonal Antibody for the Treatment of Symptomatic Patients 12-75 years Old with Perennial Allergic Rhinitis
Principal Investigator: William Schoenwetter, MD
Sponsor: Novartis Pharmaceuticals Corporation

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of a New Intravenous Monoclonal Antibody in Patients with Moderate Asthma
Principal Investigator: William Schoenwetter, MD
Sponsor: SmithKline Beecham Pharmaceuticals

A Double-Blind, Double Dummy Clinical Trial to Evalutate the Efficacy and Safety of an Inhaled Corticosteroid and a Leukotriene-Receptor Antagonist in Patients with Asthma (Steroid Naïve)
Principal Investigator: William Schoenwetter, MD
Sponsor: Integrated Therapeutics Group

A Phase III, 6-Month, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial With a 6-Month Blinded Extension Period to Assess the Efficacy, Safety, Tolerability, Steroid-Reduction, Pharmacokinetics, and Pharmacodynamics of a Subcutaneous Anti-IgE, Recombinant, Humanized Monoclonal Antibody in Adolescents and Adults with Moderate to Severe Allergic Asthma Requiring Daily Treatment with Inhaled Corticosteroids
Principal Investigator: William Schoenwetter, MD
Sponsor: Novartis Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of an Antihistamine Nasal Spray, in the Treatment of Patients with Symptoms of Vasomotor Rhinitis   
Principal Investigator: William Schoenwetter, MD
Sponsor: Wallace Laboratories

A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of a Long-Acting Bronchodilator/Inhaled Corticosteroid Combination, a Long-Acting Bronchodilator, an Inhaled Corticosteroid and placebo in Adult and Adolescent Subjects with Asthma
Principal Investigator: Richard Sveum, MD
Sponsor: Glaxo Wellcome, Inc.

A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing a Leukotriene-Receptor Antagonist with Placebo in Two-to Five-Year Old Patients
Principal Investigator: Richard Sveum, MD
Sponsor: Merck & Co., Inc.

A Stratified, Randomized, Double-Blind, Placebo-Controlled, Non-Active Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of an Influenza Medication Twice Daily for Five Days on Pulmonary Function Testing in Influenza Patients 6 years of Age with Asthma
Principal Investigator: Richard Sveum, MD
Sponsor: Glaxo Wellcome, Inc.

A Multi-Center, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of a Leukotriene-Receptor Antagonist with Placebo and an Inhaled Corticosteroid in Pediatric Patients (Prepubertal, Tanner Stage 1) with Mild Asthma
Principal Investigator: Richard Sveum, MD
Sponsor: Merck & Co., Inc.

Holding Chamber with Facemask in Patients with Asthma Age 24 Months to 47 Months (1386-99)
Principal Investigator: Richard Wyatt, MD
Sponsor: Glaxo Wellcome, Inc.

Asthma Management Initiative
Principal Investigators: Judy Kelloway, PharmD; Richard Wyatt, MD
Sponsor: Integrated Therapeutics Group

Efficacy and Safety of a New Antihistamine in Patients with Seasonal Allergic Rhinitis and Concurrent Asthma
Principal Investigator: Richard Wyatt, MD
Sponsor: Schering-Plough Research Institute

An Evaluation of a New Nebulized Inhaled Corticosteroid vs. another Non-Steriod Nebulized Drug on Asthma-Related Outcomes in Children Two- to Six-Years Old
Principal Investigator: Richard Wyatt, MD
Sponsor: AstraZeneca

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, 12-Week Study of Two Doses of an Inhaled Corticosteroid Delivered Via CFC MDI and a Valved  Holding Chamber with Facemask in Patients with Asthma Age 24 Months to 47 Months (1386-99)
Principal Investigator: Richard Wyatt, MD
Sponsor: Glaxo Wellcome, Inc.

CARDIOLOGY
TACTICS (TIMI 18) Treat Angina With a New Drug and Determine Cost of Therapy With an Invasive or Conservative Strategy
Principal Investigators: J. Mark Haugland, MD; Jackson Thatcher, MD
Sponsor: Merck & Co., Inc.

Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM)
Principal Investigator: J. Mark Haugland, MD
Sponsor: National Institutes of Health

A Phase III International Randomized, Double-Blind Placebo-Controlled Trial Evaluating the Efficacy and Safety of a New Drug in Patients with Unstable Coronary Syndromes
Principal Investigator: J. Mark Haugland, MD
Sponsor: Searle

Heart Failure Program
Principal Investigator: Joni Hoffman, RN, BS, CCRN
Sponsor: Institute for Research and Education

Community Surveillance of Congestive Heart Failure
Principal Investigator: Russell Luepker, MD, University of Minnesota
Sponsor: National Institutes of Health; National Heart, Lung and Blood Institute

A Vasopeptide Inhibitor Versus an Angiotensision Converting Enzyme (ACE) Inhibitor Randomized Trial of Utility in Reducing Events
Principal Investigator: Richard Madlon-Kay, MD
Sponsor: Bristol-Myers Sqibb Company

Amistad II:  A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Adenosine as an Adjunct to Reperfusion Therapy (Thrombolysis or Mechanical Reperfusion) in the Treatment of Acute Anterolateral Myocardial Infarction
Principal Investigator: James Milavetz, MD
Sponsor: Medco Research, Inc.

CORE Study of Octopus Myocardial Stabilizing Device
Principal Investigator: Ted Spooner, MD
Sponsor: Medtronic, Inc.

The 2nd Symphony Trial: A Phase III Multicenter, International, Randomized Double-Blind Aspirin-Controlled Trial to Evaluate The Efficacy and Safety of Two Regimens of a New Oral Platelet Glycoprotein IIB/IIIA Receptor Agonist, as Therapy for The Long Term Prevention of Secondary Vascular Events in Patients After an Acute Coronary Syndrome
Principal Investigator: Jackson Thatcher, MD
Sponsor: F. Hoffmann-Laroche

EMERGENCY MEDICINE
Assessment of Falls Among Hennepin County Children and Adolescents
Principal Investigator: Robert Knies, RN, MSN
Sponsor: Hennepin County Health Department

FAMILY PRACTICE/HEALTH EDUCATION
An Evaluation of Tobacco Cessation Guideline Implementation in Community-Based Primary Care Settings - Pilot Study
Principal Investigators: Donald Pine, MD; Susan Sullivan, PhD, MPH
Sponsors: American Academy of Family Physicians Foundation,
Institute for Research and Education

GASTROENTEROLOGY
Investigational Plan of An Investigational Device for the Treatment of Malignant
Biliary Obstruction
Principal Investigator: Martin Freeman, MD, Hennepin Faculty Associates
Sponsor: Boston Scientific Corporation

Management of Upper Gastrointestinal Hemorrhage
Principal Investigator: Ann Kools, MD
Sponsors: TAP Pharmaceuticals, Institute for Research and Education

A Comparison of Standard and Induction Interferon Alfa 2b Therapy with and without Another Drug in Patients with Chronic Hepatitis C Not Previously Treated with Interferon
Principal Investigator: Ann Kools, MD
Sponsor: Schering Corporation

Pilot Testing of a Computer Based Digestive Health Status Instrument  
Principal Investigator: Michael Newcomer, MD
Sponsor: AstraZeneca Pharmaceuticals

Assessing the Impact of a Screening Guideline for Colorectal Carcinoma
Principal Investigator: Mike Shaw, MD
Sponsor: Institute for Clinical Systems Integration

Patient-Reported Outcomes After Surgical Anti-Reflux Therapy I Modification of the Digestive Health Status Instrument (DHSI)
Principal Investigator: Michael Shaw, MD
Sponsor: AstraZeneca Pharmaceuticals

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study for Long-Term Prevention of Recurrent Peptic Ulcer Hemorrhage in Patients Infected with
Helicobacter Pylori
Principal Investigator: Michael Shaw, MD
Sponsor: National Institutes of Health

The Development of a Brief GERD Diagnostic Survey       
Principal Investigator: Michael Shaw, MD
Sponsor: AstraZeneca Pharmaceuticals

A Prospective, Randomized Study of Two Drugs for Prevention of Recurrent Duodenal and Gastric Ulcer Hemorrhage in High Risk Patients Who Ingest NSAIDS or Aspirin
Principal Investigator: Michael Shaw, MD
Sponsor: AstraZeneca

HAND THERAPY
Market Performance Evaluation of the Small (1.5 CCc) Dupel B.L.U.E.
Iontophoresis Electrode
Principal Investigator: Nancy Callinan, MA, OTR, CHT
Sponsor: Empi, Inc.

HEALTH EDUCATION CENTER
Clinic-based Physical Activity Promotion to Reduce Risk Factors for Heart Disease   
Principal Investigator: Jane Norstrom, MA
Sponsor: American Heart Association

Promoting Smoking Cessation in Hospital Patients
Principal Investigators: Susan Sullivan, PhD; Harry Lando, PhD; Donald Pine, MD; Karen Swenson, RN, MS, OCN
Sponsor: National Institutes of Health

Smoking Cessation in Patients with Diabetes: A Pilot Study to Determine Acceptability and Feasibility of Motivational Interviewing and Perceived Vulnerability Interventions in a Primary Care Setting
Principal Investigator: Susan Sullivan, PhD, MPH
Sponsor: Institute for Research and Education

Patient Preferences in Receiving Self-Care Information
Principal Investigator: Paul Terry, PhD
Sponsor: Institute for Research and Education

HEALTH RESEARCH CENTER
Employees' Responses to Report Cards About Care Systems
Principal Investigator: Jinnet Fowles, PhD
Sponsors: Agency for Health Care Policy and Research (AHCPR) and the Buyers Health Care Action Group (BHCAG)

Evaluation of Comparative Performance Reports Through a Field Experiment: Pilot
Principal Investigator: Jinnet Fowles, PhD
Sponsor: Institute for Research and Education

An Evaluation of the Current and Potential Impact of Consumer-Based Report Cards on the Health Care Marketplace
Principal Investigator: Jinnet Fowles, PhD
Sponsor: Robert Wood Johnson Foundation

Evaluation of a Decentralized Hypertension Services Program
Principal Investigator: Elizabeth Kind, MS, RN
Sponsor: Aventis Pharmaceuticals

Impact of Health-based Risk Adjustment on Managed Care for the Chronically Ill
Principal Investigator: David Knutson
Sponsor: Robert Wood Johnson Foundation

Implementing Risk-Adjustment for Medicaid
Principal Investigator: David Knutson
Sponsor: Robert Wood Johnson Foundation

Improving Quality of Care by Restructuring Provider Payments
Principal Investigators: David Knutson, Jinnet Fowles, PhD
Sponsor: Robert Wood Johnson Foundation

INFECTIOUS DISEASE
Virologic and Clinical Evaluation of a New Therapy Subsequent to Virologic Failure of a Nelfinavir Based Regimen
Principal Investigator: Leslie Baken, MD
Sponsor: Agouron Pharmaceuticals, Inc.

Genotypic and Phenotypic Characteristics of HIV-1 Isolates from Patients Failing D4T-containing Regimens   
Principal Investigator: Leslie Baken, MD
Sponsor: Glaxo Wellcome, Inc.

An Open-Label Randomized Trial Comparing the Effect on Viral Load of Standard HIV Treatment Practice (delayed phenotyping) with Treatment Based on the Antivirogram (immediate phenotyping)
Principal Investigator: Leslie Baken, MD
Sponsor: Glaxo Wellcome, Inc.

A Phase III Trial to Determine the Efficacy of a New Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America
Principal Investigator: Leslie Baken, MD
Sponsor: Vaxgen, Inc.

Combivir Protocol: Triple Antiretroviral, Glaxo Wellcome Experienced Patient Trial (TARGET) NZTA4005
Principal Investigator: Leslie Baken, MD
Sponsor: Glaxo Wellcome, Inc.

An Epidemiological Prospective Survey to Assess the Prevalence of Drug Resistance in a Group of 200 HIV-Positive Antiretroviral Naive Patients
Principal Investigator: Leslie Baken, MD
Sponsor: VICRO NV

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of a New Medication in Combination with Zidovudine (AZT) plus Lamivudine (3TC) vs. AZT plus 3TC Alone in HIV Patients with Less than One Month or No Prior Antiretroviral Treatment
Principal Investigator: Leslie Baken, MD
Sponsor: Agouron Pharmaceuticals, Inc.

A Pilot Multi-Center Open Label Study to Determine the Efficacy and Safety of Human Growth Serum in HIV Infected Patients with Unintentional Weight Loss or BCM Depletion on Combination Antiretroviral Therapy With or Without Protease Inhibitors
Principal Investigator: Harold Martin, MD
Sponsor: Serono Laboratories US

INTERNAL MEDICINE
A Randomized Controlled Trial of Clinician Feedback for Dictation
Principal Investigator: David Abelson, MD
Sponsor: Institute for Research and Education

Partners PAD Awareness, Risk & Treatment: New Resources for Survival 
Principal Investigators: Samuel Carlson, MD and Anthony Woolley, MD
Sponsors: Bristol-Myers Squibb Company, Sanofi Pharmaceuticals, Inc.

Assessing the Impact of a Preventive Services Screening Guideline
Principal Investigator: Nancy Jarvis, MD
Sponsor: Institute for Clinical Systems Improvement

VALUE – Valsartan Protocol
Principal Investigator: Anthony Woolley, MD
Sponsor: Novartis Pharmaceuticals

INTERNATIONAL DIABETES CENTER
Efficacy and Safety of Inhaled Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus Not Optimally Controlled with Diet and Exercise: A Three-Month, Outpatient, Parallel Comparative Trial
Principal Investigator: Richard Bergenstal, MD
Sponsor: Pfizer, Inc.

Epidemiology of Diabetes Intervention and Complications
Principal Investigator: Richard Bergenstal, MD
Sponsor: National Institutes of Health

Study of an Interstitial Fluid Glucose Monitoring System's Performance in Actual Home Environments of Subjects with Diabetes Mellitus
Principal Investigator: Richard Bergenstal, MD
Sponsor: Cygnus, Inc.

Efficacy and Safety of Inhaled Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus Not Well Controlled with Combination Oral Agents:  A Three-Month, Outpatient, Parallel Comparative Trial
Principal Investigator: Richard Bergenstal, MD
Sponsor: Pfizer, Inc.

The Community Diabetes Prevention Project
Principal Investigator: Richard Bergenstal, MD
Sponsor: The Foundation HSM

OTC and Professional Clinical Evaluation of HbA1c Monitoring System
Principal Investigator: Richard Bergenstal, MD
Sponsor: Metrika, Inc.

A Home-Simulated Study of an Interstital Fluid Glucose Monitoring System's Function Over a 39-Hour Time Period in Subjects with Diabetes Mellitus
Principal Investigator: Richard Bergenstal, MD
Sponsor: Cygnus, Inc.

Evaluation of Electronic Mode of Transmission for the Transfer of Blood Glucose Data Compared to Standard Methods of Follow-up Care After an Intensive Diabetes
Education Program
Principal Investigator: Richard Bergenstal, MD
Sponsor: Roche Diagnostics, Inc.

A Study Correlating Levels of Glycemia Assessed By Standard Measures of Glucose Control Compared to a New Non-invasive Optical Method of Assessing Glucose Control
Principal Investigator: Richard Bergenstal, MD
Sponsor: Roche Diagnostics

Epidemiology of Diabetes Interventions and Complications (EDIC) Substudy for Persons Without Diabetes: Normative Data for EDIC   
Principal Investigator: Richard Bergenstal, MD
Sponsor: National Institutes of Health

Clinical Evaluation of a Blood Glucose and Blood Beta-Hydroxybutyrate Monitoring System in Subjects with Type 1 Diabetes
Principal Investigator: Richard Bergenstal, MD
Sponsor: Abbott Laboratories-MediSense Products

A Clinical Evaluation of Blood Glucose Monitoring System Test Strips in the Hands of Individuals with Diabetes Mellitus
Principal Investigator: Dawn Bina, MT(ASCP), CCRC
Sponsor: Lifescan, Inc.

Meglitinide Combined With Bedtime Insulin NPH (Novolin N) in Comparison to Insulin in Any Mixture Twice a Day for the Treatment of Type 2 Diabetes Patients Previously on Insulin Monotherapy; a Randomized, Open-Label Study   
Principal Investigator: Gregory Damberg, MD
Sponsor: NovoNordisk Pharmaceuticals, Inc.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Clinical Evaluation of 3 Different Dosages of an Oral Drug in Combination with Metformin for 26 Weeks Duration in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on a Maximum Dose
of Metformin
Principal Investigator: C. Rowan DeBold, MD
Sponsor: Glaxo Wellcome Inc.

A 26-Week Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Two Different Dosages of a New Thiazolidinedione Versus Placebo in Combination With Glyburide and Metformin in Patients With Type 2 Diabetes Mellitus
Principal Investigator: C. Rowan DeBold, MD
Sponsor: SmithKline Beecham Pharmaceuticals

A Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Effects of a New Drug on Glycemic Control as Determined by Glycated Hemoglobin in Patients with Type I Diabetes Mellitus
Principal Investigator: Lisa Fish, MD
Sponsor: Amylin Pharmaceuticals, Inc.

Phase II Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of a New Oral Drug in Subjects with Type 2 Diabetes Mellitus
Principal Investigator: Lisa Fish, MD
Sponsor: Pfizer, Inc.

A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of a New Thiazolidinedione vs. Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide
Principal Investigator: Lisa Fish, MD
Sponsor: SmithKline Beecham Pharmaceuticals

An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of a New Thiazolidinedione, When Administered Twice Daily in Combination with Glyburide to Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum
Dose Glyburide
Principal Investigator: Lisa Fish, MD
Sponsor: SmithKline Beecham Pharmaceuticals

Clinical Evaluation of a Blood Glucose Monitoring System Process Improvement Sensors
Principal Investigator: Mary Johnson, RN
Sponsor: Bayer Corporation

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Clinical Evaluation of a New Drug as a Monotherapy for 12 Weeks Duration in Subjects with Type 2 Diabetes Mellitus
Principal Investigator: David Kendall, MD
Sponsor: Glaxo Wellcome, Inc.

Effect of an Oral Liquid Supplement on Glucose and Insulin Response Following a Liquid Mixed Meal in Persons With Type 2 Diabetes
Principal Investigator: David Kendall, MD
Sponsor: Novartis Nutrition Corporation

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of a New Drug in Type 2 Diabetic Patients with Dyslipidemia
Principal Investigator: David Kendall, MD
Sponsor: KOS Pharmaceuticals, Inc.

Natural History of Nephropathy in Diabetic Youth
Principal Investigators: S. Michael Mauer, MD; Martha Spencer, MD
Collaborating Institution: University of Minnesota
Sponsors: Juvenile Diabetes Foundation, Emma D. Howe Foundation of Minnesota

Field Test Evaluation of Nutrition Practice Guidelines for Gestational Diabetes Mellitus 
Principal Investigator: Diane Reader, RD
Sponsor: American Dietetic Association

Individual or Group Consults for Patients with Type II Diabetes: Which is More Cost-Effective?
Principal Investigator: Patti Rickheim, RN, MS, CDE
Sponsors: Institute for Research and Education, American Association of Diabetes Educators

Evaluation of an Outreach Program for Children and Adolescents with Diabetes
Principal Investigator: Martha Spencer, MD
Sponsor: Institute for Research and Education

Diabetes Prevention Trial – Type 1 (DPT-1)
Principal Investigator: Martha Spencer, MD
Sponsor: National Institutes of Health

Environmental Stress and the Development of Type I Diabetes (Ancillary to 1176-97-A: Diabetes Prevention Trial – Type 1I [(DPT-1])
Principal Investigator: Martha Spencer, MD
Sponsor: University of Miami

A 60 Day, Cross-Over, Clinical Study of a New Blood Glucose Monitoring System When Used By Children and Adolescents 
Principal Investigator: Martha Spencer, MD
Sponsor: Amira Medical Inc.

Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects with Type I Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial
Principal Investigator: Martha Spencer, MD
Sponsor: Pfizer, Inc.

A New Short-Acting Insulin Analogue vs. Novolin Regular Insulin, in Combination with Novolin NPH in the Treatment of Pediatric Patients with IDDM: An Open-Labeled, Randomized, Parallel Group, Multi-Center Study
Principal Investigator: Martha Spencer, MD
Sponsor: Novo Nordisk Pharmaceuticals, Inc.

Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin Therapy in Children Ages 6-11 Years with Type 1 Diabetes Mellitus:  A Three-Month, Outpatient, Parallel Comparative Trial
Principal Investigator: Martha Spencer, MD
Sponsor: Pfizer, Inc.

Validity and Reliability Testing of the Diabetes Self-Management Assessment Report Tool (D-SMART); Field Testing of the Diabetes Educator Outcomes Guide and Educator Intervention Assessment Tool
Principal Investigator: Todd Weaver, MPH
Sponsor: American Association of Diabetes Educators

MENTAL HEALTH
Rapid Access Parent Skills Training: Reduction in Disruptive Behavior Symptoms
Principal Investigator: Edward Froehlich, LICSW
Sponsor: Institute for Research and Education

Controlled Evaluation of Short Term Dynamic Psychotherapy in Patients with
Personality Disorder
Principal Investigator: Albert Sheldon, MD
Sponsor: Dalhousie University & Lions Gate Health Care Research Foundation

MUSIC THERAPY
The Use of Guided Imagery with Music Background As a Method of Anxiety and Pain Control for Cardiac Surgical Patients
Principal Investigators: Faith Broman, RN; Dawn Miller, MME, MT-BC
Sponsor: Institute for Research and Education

NEUROLOGY
Genetic Linkage Studies of Familial Spastic Paraplegia
Principal Investigator: Martha Nance, MD
Sponsor: Deane Laboratories

Genetic Studies of Multiple Sclerosis
Principal Investigator: Martha Nance, MD
Sponsor: Deane Laboratories

Go Parkinson's Research Study
Principal Investigator: Martha Nance, MD
Sponsor: Deane Laboratories

A Long-Term Open Label Safety Study of a New Drug in Migraine Patients
Principal Investigator: Frederick Taylor, MD
Sponsor: Pharmacia & Upjohn

NEUROSCIENCES
Antiplatelet Anticoagulant Aortic Atheroschlerosis (4A) Study
Principal Investigator: John Davenport, MD
Sponsor: National Heart, Lung and Blood Institute

Monitoring rt-PA Treatment for Stroke in Minnesota Community Hospitals
Principal Investigator: Sandra Hanson, MD
Sponsors: Institute for Research and Education, American Heart Association
Collaborating Institution: Hennepin County Medical Center

A Double-Blind Placebo-Controlled, Safety, Efficacy, and Dose-Response Trial of Three Intravenous Doses of a Potential Neuroprotective Agent in Patients with Acute Stroke
Principal Investigator: Sandra Hanson, MD
Sponsor: Bristol-Myers Squibb Company

A Randomized, Open-Label, Two-Period Crossover Study Comparing Preference for Different Seretonin Receptor Agonists for the Acute Treatment of Migraine
Principal Investigator: Frederick Taylor, MD
Sponsor: Merck & Co., Inc.

A Comparison of Oral Seretonin Agonists in a Double-Blind, Randomized, Parallel Group Study of Cost-Effectiveness and Quality of Life in Migraine   
Principal Investigator: Frederick Taylor, MD
Sponsor: Pharmacia & Upjohn

NURSING ADMINISTRATION
Discovering Factors Related to the Timing of Seeking Health Care for Acute
Stroke Symptoms
Principal Investigator: Sandra Dignen, RN
Sponsor: Butterworth Hospital, Grand Rapids, MI

OBSTETRICS AND GYNECOLOGY
Form and fit assessment of iontophoretic catheter   
Principal Investigator: James Presthus, MD, Ob/GYN West
Sponsor: Iotek, Inc.

Proof-of-principle study for delivery of anesthesia to the cervix and uterus via an iontophoretic catheter   
Principal Investigator: James Presthus, MD, Ob/GYN West
Sponsor: Iotek, Inc.

Use of the SURx Laparsocopic Probe for the Treatment of Female Stress Urinary Incontinence - Pivotal Study   
Principal Investigator: James Presthus, MD, Ob/GYN West
Sponsor: SURx Inc.

Pelvic Organ Support Trial
Principal Investigator: Michael Valley, MD
Sponsor: Medical University of South Carolina

OCCUPATIONAL MEDICINE
A Retrospective Comparison of Occupationally and Non-Occupationally Related Carpal Tunnel Syndrome at a Large Multispecialty Medical Center
Principal Investigator: Michael McGrail, MD
Sponsor: Institute for Research and Education

Minnesota Health Partnership: Coordinated Health Care and Disability Management — Evaluation
Principal Investigator: Michael McGrail, MD
Sponsors: Robert Wood Johnson Foundation, Allina Health System, Blue Cross Blue Shield of Minnesota, Fairview Health Services, HealthPartners, HealthSystem Minnesota, Buyers Health Care Action Group, State of Minnesota Department of Employee Relations

Minnestoa Sentinel Event Notification System for Occupational Risks (MN SENSOR)
Principal Investigator: David Parker, MD, MPH
Collaborating Institution: Minnesota Department of Health
Sponsor: Minnesota Department of Health

OCCUPATIONAL MEDICINE/HEALTH RESEARCH CENTER
Surveillance of Serious Work-Related Trauma
Principal Investigator: David Parker, MD
Sponsor: National Institute for Occupational Safety and Health Research Center

ONCOLOGY RESEARCH
A Double-Blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Anti-emetic Tablets with Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-Based or Carboplatin-Based Chemotherapy in Patients with Malignant Disease.
Principal Investigator: Martin Lee, MD
Sponsor: SmithKline Beecham Pharmaceuticals

Clinical Evaluation of Once Weekly Dosing of a Drug in Anemic Cancer Patients
Receiving Chemotherapy
Principal Investigator: Martin Lee, MD
Sponsor: Ortho Biotech

A Phase II Trial of a New Drug Administered as a Weekly One Hour Infusion in Previously Treated Patients with Advanced Urothelial Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Bristol-Myers Squibb Company

An Open-Label Trial to Determine the Effects of a Progestin Drug in Patients with Idiopathic Thrombocytopenia Purpura
Principal Investigator: Martin Lee, MD
Sponsor: Inkine Pharmaceutical Co., Inc.

A Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of a Progestin Drug in Patients who are Responding the Drug for Idiopathic Thrombocytopenia Purpura
Principal Investigator: Martin Lee, MD
Sponsor: Inkine Pharmaceutical Co., Inc.

Clinicopathologic Review of Cases of Cutaneous Lymphoma Identified by the Upper Midwest Oncology Registry Services (TUMORS) Database
Principal Investigator: Martin Lee, MD
Sponsor: Institute for Research and Education

Development of Neutropenia-Specific, Health-Related Quality of Life Questionnaire: Phase III Longitudinal Validation and Assessment of Fatigue
Principal Investigator: Martin Lee, MD
Sponsor: Amgen, Inc.
Collaborating Institution: Dartmouth-Hitchcock Medical Center

A Prospective, Randomized Trial of a New Drug for the Prevention of Irinotecan- Induced Diarrhea in Patients with Metastatic Colorectal Cancer
Principal Investigator: Martin Lee, MD
Sponsor: Novartis Pharmaceuticals Corporation

An Open-Label, Randomized, Phase III Study Comparing a New Medication in Combination with Leucovorin as First-Line Chemotherapy in Patients with Advanced and/or Metastatic Colorectal Carcinoma
Principal Investigator: Martin Lee, MD
Sponsor: Hoffman-LaRoche

Interleukin-2 in an Alternative Dose (the ILIAD trial): Treatment of Patients with Metastatic Renal Cell Carcinoma with Low-Dose Proleukin
Principal Investigator: Martin Lee, MD
Sponsor: Chiron Corporation

An Open-Label, Multicenter, Randomized, Phase II Study of 5 day Oral Chemotherapy vs. 21 Day Oral Chemotherapy vs. CPT 11 (Irinotecan) for Second-Line Therapy in Patients with Colorectal Carcinoma
Principal Investigator: Martin Lee, MD
Sponsor: SmithKline Beecham Pharmaceuticals

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

Breast Cancer Risk Factors and Diagnostic Mammogram: Sensitivity Among Women Diagnosed with Breast Cancer in Their Forties.
Principal Investigator: Carol McPherson, MSW, MPH
Sponsor: Institute for Research and Education

Pilot Study to Determine the Feasibility of Assessing Bowel, Bladder, and Sexual Function and Quality of Life in Prostate Cancer Patients and Age-Matched Controls
Principal Investigator: Carol McPherson, MPH, MSW
Sponsor: Institute for Research and Education

A Phase III, Randomized, Open-Label Study of a New Drug vs. Topotecan HCl in Patients with Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Principal Investigator: Kathleen Ogle, MD
Sponsor: SEQUUS Pharmaceuticals, Inc.

A Randomized Clinical Trial to Evaluate Advanced Nursing Care for Women Newly Diagnosed with Breast Cancer and Phase II Interventions for Newly Diagnosed Breast Cancer Patients (Addendum to original DOD grant)
Principal Investigator: Laurie Ritz, RN, MSN
Sponsor: Department of Defense

Illness Attribution and Predictors of Well-Being in Younger Women with Breast Cancer
Principal Investigator: Elizabeth Santas Kraatz, RN, PhD, AOCN
Sponsor: University of Minnesota Faculty Scholarship

Complication Rate for Sentinel Lymph Node Biopsy: Ancillary Study to Sentinel Lymph Node Biopsy for Patients with Breast Cancer
Principal Investigator: Karen Swenson, RN, MS, AOCN
Sponsor: Institute for Research and Education

Implementation and Evaluation of a Program to Promote Smoking Cessation in
Hospitalized Patients
Principal Investigator: Karen Swenson, RN, MS, OCN
Sponsor: The Foundation

Early Detection of Occult Micrometastases by Lymph Node Mapping and RT-PCR in Patients with Invasive Breast Cancer: A Multi-Center Trial (Multi-Center Sentinel Node)
Principal Investigator: Todd Tuttle, MD
Sponsors: Department of Defense, Institute for Research and Education

OPHTHALMOLOGY
Clinical Evaluation of the Performance of Photochromic Spectacle Lenses 
Principal Investigator: Robert Campbell, MD
Sponsor: Transitions Optical

ORTHOPEDICS
A Randomized, Comparative, Multi-Center Clinical Trial Evaluating a New Device and Conventional Treatment in Metaphysical Fractures of the Distal Radius
Principal Investigator: Jeffrey Husband, MD
Sponsor: Norian

A Multicenter, Multinational, Randomized, Double-Blind Comparison of Two Anti-thrombic agents in the Prevention of Deep Vein Thrombosis and Symptomatic Pulmonary Embolism After Elective Hip Replacement or Revision 
Principal Investigator: Paul Johnson, MD
Sponsor: Sanofi Research

A Prospective, Double-blind, Randomized, Placebo Controlled Phase I/II Study to Evaluate the Safety of a Synthetic Peptide and its Effect on the Rate of Healing in Distal Radius Fractures
Principal Investigator: Benjamin Levine, MD
Sponsor: OrthoLogic, Corp.

A Randomized, Multi-Center, Double-Blind, Placebo Controlled Study of the Jonto Phoretic Administration of an adenocorticosteroid in the Treatment of Patients with Acute Epicondylitis
Principal Investigator: Benjamin Levine, MD
Sponsor: Iomed, Inc.

A Randomized, Multi-Center, Double-Blind, Placebo controlled Study of the Iontophoretic Administration of an Adrenocorticosteroid in the Treatment of Patients with
Dequervain's Disease
Principal Investigator: Benjamin Levine, MD
Sponsor: Iomed, Inc.

PEDIATRICS
Quantitative and Qualitative Assessment of the Reasons for Poor Immunizations in the HealthPartners Prepaid Medical Assistance Program, Identifying Opportunities to Improve Vaccination Rates
Principal Investigator: Renner Anderson, MD
Sponsor: HealthPartners Foundation
Collaborating Institution: HealthPartners

Long Term Follow-Up of the Safety, Tolerability and Immunogenicity of One vs. Two Injections of New Production Lots of an Investigational Varicella Vaccine in Healthy Children
Principal Investigators: Renner Anderson, MD; Robert Karasov, MD; Thomas Helm, MD
Sponsor: Merck & Co., Inc.

A Newborn Welcome & Outreach program to Improve Immunizations Rates in the HealthPartners Prepaid Medical Assistance Program Population
Principal Investigators: Renner Anderson, MD and Peter Harper, MD, HealthPartners
Sponsor: HealthPartners Foundation

An Evaluation of the Clinical Usefulness of Biofeedback Training Games with
Pediatric Populations
Principal Investigator: Timothy Culbert, MD
Sponsor: Institute for Research and Education

A Dose Selection Study in Healthy Children Comparing Measles, Mumps, Rubella (MMR) and Varicella Vaccine to an MMR Vaccine Given Concomitantly with a New Varicella Vaccine in Separate Injections
Principal Investigator: Robert Karasov, MD
Sponsor: Merck & Co., Inc

Pediatric Endocrinology
International Growth Study
Principal Investigators: Michael Ainslie, MD; Martha Spencer, MD
Sponsor: Pharmacia & Upjohn

PLASTIC SURGERY
Saline-Filled Mammary Implant Reconstruction
Principal Investigators: Marie Christensen, MD; Edward Lovaas, MD; Jane Nemecek, MD
Sponsor: McGhan Medical Corporation

Silicone-Filled Breast Implant Adjunct Clinical Study
Principal Investigator: Marie Christensen, MD; Mark Lovaas, MD; Jane Nemecek, MD
Sponsor: McGhan Medical Corporation

A Multi-Center, Open Trial to Study the Safety and Efficacy of Breast Implants for Breast Augmentation and Reconstruction
Principal Investigator: Jane Nemecek, MD
Sponsor: LipoMatrix, Inc.

PODIATRY
Plantar Fasciitis: A Prospective Treatment Study
Principal Investigator: James Mazzuca, MD
Sponsor: Northstar Orthotics, Inc.

Orthographic Evaluation of the Metatarsophalangeal Joint Capsule Repair
Principal Investigator: Stephen Powless, DPM
Sponsor: Institute for Research and Education

PULMONARY
Long-term, Open-Label, Multicenter Extension Trial of Sodium Oxybate Oral Solution for the Treatment of Narcolepsy  
Principal Investigator: Salim Kathawalla, MD
Sponsor: Orphan Medical

Open-Label, Multi-Center, Six-Month Trial of Sodium Oxybate Oral Solution for The Treatment of Narcolepsy in Study Drug Naive Patients   
Principal Investigator: Salim Kathawalla, MD
Sponsor: Orphan Medical

Contact Taste Testing of Sodium Oxybate Oral Liquids and Placebo Formulations
Principal Investigator: Salim Kathawalla, MD
Sponsor: Orphan Medical

Long-Term, Open-Label, Multi-Center Extension Trial of an Orally Administered Drug for the Treatment of Narcolepsy Symptoms
Principal Investigator: Salim Kathawalla, MD
Sponsor: Orphan Medical, Inc.

PULMONARY/METHODIST HOSPITAL SLEEP CENTER
Evaluation of the Effectiveness of a Mandibular Repositioning Device (PM Positioner) for the Treatment of Obstructive Sleep Apnea & Snoring
Principal Investigators: Jonathan Parker, DDS; Kevin Komadina, MD; Paul Burman, MD
Sponsors: The Foundation, Institute for Research and Education

RADIATION THERAPY
Phase I-II Study of Radiation Therapy Followed by Concurrent Paclitaxel and Fractionated Stereotactic Radiation Therapy for Patients with Newly Diagnosed Anaplastic Astrocytoma or Glioblastoma Multiforme
Principal Investigator: Paul Sperduto, MD
Sponsor: Bristol-Myers Squibb Company

RADIOLOGY/ONCOLOGY RESEARCH
Multi-center International Evaluation of Diagnostic Methods for Breast Cancer
Principal Investigator: Mary Lechner, MD
Sponsor: Dupont Pharmaceuticals Company

REHABILITATION SERVICES/SPEECH & LANGUAGE PATHOLOGY
Randomized Study of Two Interventions for Liquid Aspirations: Short and
Long-Term Effects   
Principal Investigator: Lynne Conley, MA
Sponsor: National Institutes of Health and the American
Speech-Language-Hearing Association

RHEUMATOLOGY TREATMENT AND RESOURCE CENTER
An Active Comparator and Placebo-Controlled Parallel-Group Study to Assess Safety and Efficacy of MK-0966 in Rheumatoid Arthritis Patients 
Principal Investigator: Carolyn Bowles, MD
Sponsor: Merck & Co., Inc

Evaluation of Outcomes Among Persons with Fibromyalgia Assigned to Two Management Strategies over a One-Year Course
Principal Investigator: Janet Lima, RN, MPH
Sponsors: Arthritis Foundation-MN Chapter, The Foundation

Treatment of Early Rheumatoid Arthritis: The Role of Doxycycline in Combination
with Methotrexate  
Principal Investigator: John Schousboe, MD
Sponsors: Institute for Research and Education; University of Nebraska Medical Center

A Multicenter Study of Tissue Typing: Comparison of Individuals with Rheumatoid Arthritis and their Biological Parents 
Principal Investigator: John Schousboe, MD
Sponsor: University of Nebraska Medical Center

Rheumatoid Arthritis Clinical Research Serum and DNA Bank
Principal Investigator: John Schousboe, MD
Sponsor: University of Nebraska Medical Center

Six Month Open Label Safety Trial of Enbrel (etanercept) plus Hydroxychloroquine, Sulfasalazine, or Injectable Gold in Patients with Rheumatoid Arthritis
Principal Investigator: John Schousboe, MD
Sponsor: University of Nebraska Medical Center

A Multi-Center, Randomized, Double-Blind Study of Glucosteroids and Placebo for Treatment of Giant Cell (Temporal) Arteritis
Principal Investigator: John Schousboe, MD
Sponsors: Institute for Research and Education, The Foundation, National Institute of Allergy and Infectious Diseases

A Randomized Study to Examine the Effects of Nurse Care Management and Education on Patient Follow-Up, Health Care Behavior, and Satisfaction with an Osteoporosis
Education Program
Principal Investigators: John Schousboe, MD; C. Rowan DeBold, MD
Sponsor: Merck & Co., Inc.

RHEUMATOLOGY TREATMENT AND RESOURCE CENTER/HAND THERAPY
A Randomized, Controlled Study of 6- and 12-Month Effect of Hand- and Forearm-based Functional Ulnar Drift Orthoses on Patients with Rheumatoid Arthritis
Principal Investigators: John Schousboe, MD; Erica Stern, PhD; Nancy Callinan, OTR
Sponsor: National Arthritis Foundation
Collaborating Institution: University of Minnesota

STRUTHERS PARKINSON'S CENTER
A Pilot Study of Patient Satisfaction and Quality of Life in Parkinson's Disease Treated with a New Drug in a Usual Care Setting
Principal Investigator: Paul Silverstein, MD, Minneapolis Clinic of  Neurology
Sponsor: Pharmacia & Upjohn

An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of "off" Episodes in Patients with "on-off" or "wearing-off" Effects Associated with Late Stage Parkinson's Disease (1406-99)
Principal Investigator: Paul Silverstein, MD, Minneapolis Clinic of Neurology
Sponsor: MYLAN Pharmaceuticals, Inc.

SURGERY
Adjuvant Tamoxifen Therapy in Old Age
Principal Investigators: Catherine Borbas, PhD, MPH; William Gamble, MD
Sponsor: Healthcare Education & Research Foundation, Inc.

SURGERY/ONCOLOGY RESEARCH
A Pilot Study of Radiofrequency-Induced Coagulation Necrosis of Unresectable Liver Tumors
Principal Investigator: Todd Tuttle, MD
Sponsor: Institute for Research and Education

Sentinel Lymph Node Biopsy for Patients with Breast Cancer   
Principal Investigator: Todd Tuttle, MD
Sponsor: Institute for Research and Education

A Multicenter Trial of a New Drug for Melanoma Patients with Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy
Principal Investigator: Todd Tuttle, MD
Sponsor: Schering Corporation

Detection of Occult Nodal Metastases in Colonic Carcinoma with Sentinel Lymph Node Biopsy
Principal Investigator: Todd Tuttle, MD
Sponsor: Institute for Research and Education

Z0010 A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women with Clinical Stage T1 or T2 Breast Cancer
Principal Investigator: Todd Tuttle, MD
Sponsor: American College of Surgeons

Z0011 A Randomized Trial of Axillary Node Dissection in Women with Clinical Stage T1 or T2, NO, MO Breast Cancer Who Have a Positive Sentinel Node 
Principal Investigator: Todd Tuttle, MD
Sponsor: American College of Surgeons

URGENT CARE
Do Football Players Under-Report Head Injury Symptoms, and if so, Why?
Principal Investigator: Hilarion Woronzoff-Dashkoff
Sponsors: Institute for Research and Education, Hennepin County Medical Center

UROLOGY
A Phase III Long-Term Open Label, Flexible Dose, Safety Extension Study of a New Drug in the Treatment of Male Erectile Dysfunction
Principal Investigator: William Borkon, MD
Sponsor: TAP Pharmaceuticals

An Open-Label Study to Evaluate Patient Acceptance and Safety of a New Drug in Urge Urinary Incontinence
Principal Investigator: Kevin Zhang, MD
Sponsor: ALZA Pharmaceuticals

Research Fellow Awards
Rapid Access Parent Skills Training: Reduction in Disruptive Behavior Symptoms (1338-99)
Principal Investigator: Edward Froehlich, LICSW

A Multimodel Approach to Perioperative Pain Management in Abdominal Hysterectomy Patients:  The Use of Preemptive Analgesia and Restriction of Opiates
Principal Investigator: John Reichert, MD

Student Research
An Assessment of Siris Silver Ring Splints and Their Use for the
Nalebuff Type I Thumb Condition
Principal Investigator: Jessica Curkovic, OTS

How Do Nurse Practitioners Maintain Nursing in Their Practice?
Principal Investigator: Joni Hoffman

A Comparison of the Perception of Pain Intensity Among Oncology Patients, Family Caregivers, and Oncology Nurses         
Principal Investigator: Dawn Jenniges, RN

Comparison of Sensory Characteristics on the Sensory Profile: Children with Different Types of Attention Deficit Disorder and Typical Children
Principal Investigator: Laura Sopeth