Better Care through Better Research

Nuedexta

Demonstrate whether or not Nuedexta can improve speech and swallowing difficulties in patients with ALS (Amyotrophic Lateral Sclerosis).

Total of 5 study visits over a 4 month period.

Participation required diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria).

MNCAM, Minnesota Program in CAM Clinical Research

Sponsor
National Center for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes of Health (NIH)

Description
The primary purpose of this program is to foster rigorous, high-quality, scientific research in complementary and alternative medicine (CAM) by providing experience and training in clinical research methods to promising practitioners and researchers at both the pre- and post-doctoral level. The secondary purpose is to enhance the interconnectedness of the Twin Cities CAM research community. This Program enrolls post-doctoral Fellows for a 2-3 year commitment. This Program also enrolls pre-doctoral health professional students for summer internships.

Eight Year Data from an Integrated Health Care Setting

Sponsor
National Center for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes of Health (NIH)

Description
Using data generated by patient-visits to an alternative medicine clinic that has been located on the campus of a mainstream healthcare facility since 1993, this health services research project contributes information valuable to healthcare and insurance executives who are interested in establishing systemic-level integration of CAM and conventional medicine.

Chiropractic, Medication, and Self-Care for Neck Pain
Sponsor
Health Services Research Administration (HRSA)

Description
This randomized, observer-blinded clinical trial compares the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for recent-onset neck pain. Efficacy is compared in the short term (after 6 weeks) and long term (after 52 weeks), using patient ratings as the main outcome measure. Please visit Northwestern Health Sciences University (NWHSU) for more information.

Manipulation, Exercise, and Self-care for Low Back Pain
Sponsor
Health Services Research Administration (HRSA)

Description
This is a randomized, observer-blinded clinical trial comparing chiropractic spinal manipulation, rehabilitative exercise, and self-care education for patients with chronic low back pain. Interventions are compared for their short- and long-term efficacy, as well as their cost-effectiveness and cost-utility. Please visit Northwestern Health Sciences University (NWHSU) for more information.

Chiropractic and Exercise for Seniors with Low Back Pain
Sponsor
Health Services Research Administration (HRSA)

Description
This study seeks to identify effective therapies for low back pain, and to discover the best methods for enhancing health and functional capacity, in patients 65 years of age and older, with low back pain of more than 6 weeks duration. The study compares three treatments for reduction in patient ratings of low back pain after 12 weeks of therapy and one year after therapy ends. The three treatments are chiropractic manipulation and home exercise, supervised rehabilitative exercise and home exercise, and home exercise alone.

Chiropractic and Exercise for Seniors with Neck Pain
Sponsor
Health Services Research Administration (HRSA)

Description
This study identifies effective therapies for patients 65 years and older who suffer with chronic neck pain to ameliorate the pain and to enhance their functional capacity. The study compares chiropractic treatment and home exercise, supervised rehabilitative exercise and home exercise, and home exercise alone, for reduction of patient-reported neck pain.

Manipulation, Exercise, and Self-care for Chronic Neck Pain
Sponsor
Health Services Research Administration (HRSA)

Description
This study compares rehabilitative exercise, chiropractic spinal manipulation combined with rehabilitative exercise, and self-care education in reduction of patients’ self reports of neck pain after three and nine months of treatment. The study also compares the cost-effectiveness and cost utility of the treatments, evaluates changes in cervical spine function, examines associations between cervical function and patient-rated outcomes, and identifies predictors of outcome. Please visit Northwestern Health Sciences University (NWHSU) for more information.

ViP, The Effects of Rofecoxib (Trade Name Vioxx) in Reducing the Risk of Prostate Cancer

Sponsor
Merck

Description
ViP study is a double-blinded, randomized, placebo-controlled trial evaluating the effects of rofecoxib 25mg compared with placebo in decreasing the incidence of capsular and extracapsular prostate cancer in men with initially elevated risk.

CAPPS, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
Sponsor
Ortho-McNeil Pharmaceutical Inc.

Description
The objective of this study is to compare the analgesic efficacy and safety of tramadol HCl and acetaminophen versus placebo for the treatment of painful diabetic neuropathy.

ACCORD, Action to Control Cardiovascular Risk in Diabetes
Substudies: ACCORD-Mind and ACCORD-Eye
Sponsor and Initiator
National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)

Description
This trial addresses the challenges to cardiovascular health of persons with type 2 diabetes by testing three complementary medical treatment strategies. Participants are randomly assigned to a treatment regimen involving either aggressive or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they are assigned to either a blood pressure intervention or blood fat intervention.

ORIGIN, Outcome Reduction with Initial Glargine Intervention
Sponsor
Aventis

Description
ORIGIN is a 2×2 factorial study investigating the prevention of cardiovascular morbidity and mortality in people with type II diabetes, impaired glucose tolerance, and/or fasting glucose ≥110 mg/dL. The two factors are insulin glargine (Lantus) (variable dose vs. standard care), and omega-3 fatty acid (865mg vs. placebo). Participants are randomized to one of the four possible treatment combinations.

DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication
Sponsor
Aventis

Description
DREAM is an international, multi-center, randomized, double-blinded, placebo-controlled trial involving 4,000 participants at high risk for developing type II diabetes mellitus. Participants receive ramipril (ACE-I) or placebo and rosiglitazone (TZD) or placebo (therefore, there are 4 treatment combinations possible). The goal is to determine which group has a lower prospective incidence of DM. The study also collects observational data useful for establishing epidemiological associations between cardiovascular disease and type II diabetes mellitus.

SEACOAST, The Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia: A Dose-Ranging StudyInitiator and Sponsor
Kos Pharmaceuticals, Inc.

Description
Niacin and simvastatin are medications that both have been approved to treat high cholesterol. The purpose of this study is to compare the effectiveness and safety of a combination of niacin (extended release) and simvastatin (immediate release), called NS, at different doses, relative to monotherapy with Zocor.

TACT, Trial to Assess Chelation Therapy
Sponsors
National Heart, Lung and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes of Health

Description
This randomized, double-blinded, placebo-controlled trial will enroll 2372 participants at high risk for heart disease. It is a 2×2 factorial: One factor is chelation therapy vs. placebo, and the other is high-dose antioxidant vitamin/mineral daily supplements vs. placebo. Participants are followed for an average of 2.5 years.

ALLHAT, Anithypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Sponsor and Initiator
Sponsor
National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)

Description
ALLHAT, conducted from 1994 to 2002, consisted of 2 trials: one compared a diuretic with newer antihypertensive drugs to start blood pressure-lowering treatment; the other compared a statin drug to usual care. The study was the first one done exclusively in patients with high blood pressure and involved over 10,000 participants, making it the largest hypertension clinical trial ever conducted. Findings indicated that less costly, traditional diuretics work better than newer medicines to treat high blood pressure and prevent some forms of heart disease.

AVALON, Evaluation of the Safety and Efficacy of Dual Therapy with Atorvastatin plus Amlodipine when Compared to Either Therapy Alone in a Treatment of Patients with Simultaneous Hyperlipidemia and Hypertension
Sponsor
Pfizer Pharmaceuticals

Description
AVALON enrolled 5 participants with both high blood pressure and high LDL cholesterol to determine the efficacy of a hypertension agent (Amlodapine), and a lipid-lowering agent (Atovastatin), either separately or together, for control of both blood pressure and LDL cholesterol.

HDFP, Hypertension Detection and Follow-up Program
Sponsor
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)

Description
This national, multi-site study, which was conducted between1971 and 1983, enrolled 10,940 participants aged 30-69 with mild hypertension. Participants were randomized to 2 treatment arms, were treated for 5 years, and participated in mortality follow-up for 1 year after study intervention. Based on study results, investigators concluded that effective treatment of mild hypertension reduces premature deaths by 20%.

ONTARGET: Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial
TRANSCEND: Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.

Description
The primary purpose of OnTarget is to compare the efficacy of telmisartan (an antiotensin II antagonist) and ramipril (an ACE-Inhibitor) either together or each alone, in reducing the incidence of cardiovascular disease (CVD) events among individuals at high CVD risk. Using the same outcomes, TRANSCEND compares telmisartan to placebo for individuals who are unable to take ACE-Inhibitors because intolerable side effects.

SHEP, Systolic Hypertension in the Elderly
Sponsor and Initiator
National Heart, Lung & Blood Institute (NHLBI), US National Institutes of Health (NIH)

Description
This national, multi-site study, which was conducted between 1985 and 1991, enrolled 4,736 elderly participants (from 447,921 screenees) with systolic hypertension. Participants were followed monthly until SBP reached goal or the maximum level of stepped-care treatment was received. Average length of follow-up was 4.5 years. Based on study results, investigators concluded that lowering of systolic blood pressure through pharmacological therapy reduced the combined rate of fatal and non-fatal stroke by 36% in men and women 60 years of age and older. The results of this study changed the treatment of systolic hypertension for millions of senior citizens. The Berman Center was one of 14 clinical sites. The Berman Center enrolled 302 participants; 99% of Berman Center participants completed the trial.

TOMHS, Treatment of Mild Hypertension Study
Sponsors
National Heart, Lung & Blood Institute (NHLBI), U.S. National Institutes of Health (NIH);
Pfizer, Merck, Sharpe, and Dohme

Description
This study was a randomized, controlled, double-blind trial with 902 participants conducted at four clinical sites in the U.S. from 1986 to 1992. The study compared the combined effects of diet treatment and 1 of 5 active drug regimens with diet treatment alone for the long-term management of mild hypertension (diastolic BP 85-99 mmHg). Study investigators concluded that nutritional-hygienic therapy is effective in treating mild hypertension, and that significant blood pressure lowering can be achieved by adding any one of five different classes of antihypertensive agents.

TROPHY, Trial of Preventing Hypertension
Sponsor
Astra-Zeneca

Description
Individuals with untreated, high-normal blood pressure (130 mmHg ≤ SBP ≤ 139 mmHg and/or 85 mmHg ≤ DBP ≤ 89 mmHg) are believed to be at elevated risk for developing more severe hypertension and its cardiovascular disease complications. This multi-site, placebo-controlled, double-blinded trial investigates the efficacy of Candesartan for lowering blood pressure in such individuals.

SHARP, Study of Heart and Renal Protection

Sponsored by: University of Oxford, UK
Funded by: Merck Schering Plough

Description
SHARP is an international, double-blinded, placebo-controlled, randomized trial sponsored by the University of Oxford, UK. The Berman Center is the US Regional Coordinating Center (RCC). The Berman Center is also a SHARP clinical site, enrolling participants locally.

SHARP will enroll approximately 9,000 patients with Chronic Kidney Disease (CKD) without coronary heart disease (CHD). Its purpose is to assess the effect of a cholesterol-lowering therapy for the reduction of cardiovascular (CV) events (non-fatal myocardial infarction or cardiac death, non-fatal or fatal stroke, or revascularization). Of the 9,000 participants, 3,000 are expected to be on dialysis and 6,000 pre-dailysis. The active treatment is a combination of simvastatin (20mg daily) and ezetimibe (10mg daily).

Minocycline in ALS
Sponsor
Columbia University and N.I.H.

Description
The purpose of this study is to investigate if minocycline slows ALS progression. All study visits and evaluations are performed at the Berman Center.

Co-Enzyme-Q-10 in ALS
Sponsor
Columbia University and N.I.H.

Description
The purpose of this study is to evaulate if high dose Co-Enzyme-Q-10 slows functional decline in ALS. All study visits and evaluations are performed at the Berman Center.

IGF-I (Myotrophin) in ALS
Sponsor
Great Lakes ALS Consortium

Description
This project, tests the efficacy of the investigational drug IGF-I (Insulin-like Growth Factor) for slowing the progression of ALS. IGF-I is a growth factor that has shown promise in protecting the motor neurons in the brain and spinal cord. The study is a double-blinded, placebo-controlled trial in which intervention lasts for 24 months. This study is closed to enrollment.

TCH-346
Sponsor
Novartis Pharmaceuticals

Description
TCH 346 is an investigational oral medication, that may slow the progression of ALS (almyotrophic lateral sclerosis) by interfering with a glycolytic enzyme that is suspected of causing programmed death of motor neuron cells. This study has been completed.

VEST-A device study for ALS patients
Sponsor
Advanced Respiratory

Description
The VEST is a device that the patient wears which oscillates the patient’s chest wall at high frequencies to keep the airway clear. The purpose of this study is to test the hypothesis that use of the VEST for three months will prevent pulmonary complications, such as pneumonia, in ALS patients. This study has been completed.

Celebrex in ALS (Amyotrophic Lateral Sclerosis)

Description
This study enrolled 300 ALS patients across the U.S., whose disease duration had been less than two years. It was a placebo-controlled, double-blinded study to evaluate the efficacy of Celebrex in slowing the progression of ALS during the 12-month intervention period. This study has been completed.

SPS3, Secondary Prevention of Small Subcortical Strokes Trial

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Description
The goal of this study is to identify the optimal combinations of antiplatelet therapy (aspirin and clopidogrel vs. aspirin alone) and blood pressure control (intensive vs. less intensive control) for preventing recurrent strokes and cognitive decline in patients who have experienced a small sub-cortical stroke.

WHI, Women’s Health Initiative

Initiator and Sponsor

National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH)

Description
A major piece of Berman Center activity since 1992, the Women’s Health Initiative (WHI) was one of the first large, multi-site, long-term studies of women’s health. A total of 161,861 women have been participating throughout the U.S. Participants were randomized to different treatment arms, including dietary modification, hormone replacement, calcium and vitamin D supplementation. Their health status has been followed for more than 12 years, paying particular attention to the major causes of death and health problems in women: cancer, heart disease, and broken bones.