DukeHealth.org: Duke Clinical Trials

Phase 3 Randomized Double-Blind Pacebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer

Fri, 26 Feb 2010 09:45:49 -0500

This study is a multinational phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral MDV3100 in patients with progressive castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

The primary purpose is to determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.

You may be eligible to participate in this clinical trial if you fit the following criteria.

Inclusion Criteria

Progressive prostate cancer
Medical or surgical castration with testosterone less than 50 ng/dl
One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel (Taxotere)
ECOG performance status 0-2
Adequate bone marrow, hepatic, and renal function
Able to swallow the study drug and comply with study requirements
Informed consent

Exclusion Criteria

Metastases in the brain or active epidural disease
Another malignancy within the previous five years
Clinically significant cardiovascular disease
Gastrointestinal (GI) disorder affecting absorption

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate.

If you do not qualify for the trial, site personnel will explain the reasons.

L-carnitine Supplementation Effects on Mitochondrial Performance and Insulin Action in Pre-Diabetics

Wed, 17 Feb 2010 13:00:10 -0500

Are you overweight, inactive, and 60 years or older?

We are looking for male and female volunteers to participate in a nutritional supplementation research study at Duke.

Eligibility Requirements

You may qualify if you are:

Over 60 years of age
Non-smoker
Moderately overweight
Inactive (exercising less than two days per week)
Willing to take carnitine daily, an FDA-approved nutritional supplement

Compensation

Participants will receive compensation of up to $400 upon completion of the study.

Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Wed, 17 Feb 2010 12:51:09 -0500

Want to exercise?

We are looking for volunteers to participate in an exercise research study at Duke.

Eligibility Requirements

You may qualify if you are:

At least 70 years of age
Non-smoker
Able to walk a city block without use of a cane
Not currently exercising more than one day a week
Willing to exercise three days a week
Live or work within a 20 mile radius of Duke

Study Requirements and Compensation

Qualifying participants may receive up to $450 upon completion of three months of supervised exercise training and all required testing visits.

RDEA594 and Allopurinol in Gout Patients

Mon, 15 Feb 2010 09:48:46 -0500

The purpose of this study is to assess the effects of an investigational drug, RDEA594, when taken in combination with allopurinol and colchicine, on the amount of uric acid in the blood.

Eligibility Requirements

Adults ages 18-75 who have been taking 300 mg of allopurinol as their only gout treatment may be eligible.

Study Requirements

The study takes place at the Duke Clinical Research Unit (DCRU) and requires a screening visit and 11 additional outpatient visits.

Compensation

Compensation is provided.

Genetics, Genomics, and Proteomics of Idiopathic Interstitial Pneumonias

Thu, 11 Feb 2010 10:02:05 -0500

Identification of Susceptibility Genes, Biomarkers, and Molecular Phenotyping

The purpose of this study is to:

Investigate inherited genetic factors that play a role in the development of pulmonary fibrosis and to identify a group of genetic loci/genes that predispose individuals to develop idiopathic interstitial pneumonia (IIP).
Develop biomarkers using proteomic and genomic approaches that will facilitate establishing the diagnosis of IIP.
Reclassify IIPs based on genetic, genomic, and proteomic phenotyping.

The patients with pulmonary fibrosis or idiopathic interstitial pneumonia such as IPF will include study subjects from National Jewish Health and DUMC.

We will search for genes that increase susceptibility to developing pulmonary fibrosis using families with two or more members with pulmonary fibrosis or sporadic cases of pulmonary fibrosis to perform genome wide association studies (GWAS) and linkage studies in selected families.

The second goal is to identify a molecular signature/biomarker that distinguishes IIP and the subtypes of IIP in peripheral blood and lung tissue to improved diagnostic accuracy of IIPs. We will use a DNA microarray-based strategy to screen peripheral blood and lung tissue.

Eligibility Requirements

Proband cases are included in the study if they meet ATS diagnostic conventions for having Idiopathic Interstitial Pneumonia (IIP) with diagnosis at 18 years of age or older.
Additional family members are included in the study if at least two members within three degrees of relationship are diagnosed with or suspected of having Idiopathic Interstitial Pneumonia.
Any case of sporadic IIPs and other ILDs will be eligible.

Exclusion Criteria

Families in which affected individuals were diagnosed prior to 18 years of age, or any ILD where the pulmonary fibrosis was made as part of a larger genetic syndrome.

INSPIRE II

Tue, 09 Feb 2010 14:59:21 -0500

INSPIRE is an NIH-funded trial investigating the benefits of a caregiver-assisted telephone-based coping skills training program in people with chronic obstructive pulmonary disease (COPD).

This study aims to help people with COPD and their caregivers cope with symptoms, enhance quality of life, and improve physical functioning.

If you qualify to participate you may receive:

Skills to help you cope better with symptoms, to increase your physical activity, and to reduce any emotional distress.
A better understanding of COPD and its treatment.
$100 compensation for your time and travel.

AAKOMA Project, Phase II

Thu, 04 Feb 2010 14:45:30 -0500

The African American Knowledge Organized for Mindfully-Healthy Adolescents (AAKOMA ) Project seeks to create a new approach and develop and test materials to be used in training clinicians to conduct an intervention to increase African American adolescents’ and families’ psychiatric treatment engagement.

Overall, the study is designed as both a mechanism to create knowledge about the non-financial, psychosocial barriers that depressed African Americans and their families experience regarding treatment use and a mechanism for creating culturally relevant and effective approaches to engaging African American families in adolescent and familial mental health research.

Alfiee M. Breland-Noble, PhD, is an assistant professor in the Department of Psychiatry & Behavioral Sciences at Duke University Medical Center and the director of The AAKOMA Project.

Antoinette Burriss is the study coordinator and Mrs. H. Kathy Poole (recently retired from the Durham Public Schools) is our lead community liaison.

With community and institutional support, the research team completed Phase I of the study in the summer of 2009. Using the data collected (regarding African American perceptions of barriers to treatment engagement and research on depression) the research team is currently framing the proposed treatment, "Improving Readiness to Change for African American Adolescents and Families."

Eligibility Requirements

We are seeking individuals (between 11 and 17 years of age) with non-bipolar, depressive disorder diagnoses (i.e. major depressive disorder, dysthymia, depressive disorder not otherwise specified) to take part in our pilot clinical study.

Excessive Daytime Sleepiness (EDS) Associated with Narcolepsy

Thu, 04 Feb 2010 08:48:33 -0500

We're undertaking a research study of an investigational drug for excessive daytime sleepiness (EDS) associated with narcolepsy.

Eligibility Requirements

To qualify for this study, you must:

Be between the ages of 18 and 55
Be in generally good health
Have experienced excessive sleepiness in connection with a narcolepsy diagnosis
Not currently be diagnosed with a sleep disorder other than narcolepsy

Andrew Krystal, MD, of the Duke Sleep Disorders Center, is studying the safety and effectiveness of an investigational drug and how it may improve EDS associated with narcolepsy. Being sleepy throughout the day is more than just a nuisance, it’s a heavy burden. If you're narcoleptic and routinely find yourself feeling really sleepy during the day, you might suffer from EDS.

Compensation

If you qualify for the study, all study medication, exams, and procedures associated with the study will be provided at no cost to you, and you may be compensated for your time and travel.

Study of Soy Isoflavones in Asthma (SOYA)

Mon, 01 Feb 2010 09:37:54 -0500

Physicians at the Duke Asthma Clinical Research Center (ACRC) are studying the influence of soy isoflavones (found in soybeans) on asthma.

Eligibility Requirements

To participate in this study, you must meet the following eligibility requirements:

Your asthma must have been diagnosed by a physician.
You must currently take a daily asthma control medicine and still have asthma symptoms.
Individuals 12 years or older (adults) may be eligible for this study.

Study Requirements

The study involves nine visits over six months.

Compensation

Subjects receive:

Study medication (soy isoflavones or placebo)
Lung function testing
Compensation for participation

Study to Assess the Safety of Uridine in the Treatment of Bipolar I Depression

Tue, 26 Jan 2010 13:26:04 -0500

A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study to Assess the Safety of Uridine in the Treatment of Bipolar I Depression

The purpose of this study is to see how RG2417 affects symptoms of bipolar depression.

Study Requirements

People between 18 and 65 years old who have been diagnosed with bipolar I depression are needed for this study. The study is 16 weeks long, with 11 scheduled visits at Duke.

Compensation

If all study visits are completed, the patient will receive a total of $350 as study compensation.

Double-Blind, Placebo-Controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Tue, 26 Jan 2010 10:07:11 -0500

The purpose of this research study is to gather information about how safe and effective RGH-188 (cariprazine) is for patients with bipolar depression.

Study Requirements

To participate in this study, you must meet the following requirements:

Be between the ages of 18 and 65
Cannot take antidepressants or anti-anxiety medications other than the study drug during participation
Come to 12 scheduled visits at Duke over a 12-week period

Compensation

If all study visits are completed, the patient will receive a total of $440 as study compensation.

Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE)

Thu, 14 Jan 2010 14:24:00 -0500

This study examines vitamin D and its possible role in disease prevention.

Eligibility Requirements

Patients with type 2 diabetes who are 50 years of age or older and have had a heart attack, heart surgery, stroke, or are on blood pressure and/or cholesterol-lowering medication may be eligible to participate in this trial.

Patients can take diabetes medicine, but no insulin.

Compensation

Patients will be compensated for completed visits.

Drug Study for Patients with Genotype 1 Chronic Hepatitis C Infection

Tue, 05 Jan 2010 15:33:39 -0500

Duke University Medical Center is conducting a study to test the safety and effectiveness of a study drug called IDX184 when given in combination with ribavirin (RBV) and pegylated interferon (Peg-IFN) in subjects with genotype 1 chronic hepatitis C infection.

Eligibility Criteria

To participate in this study, you must be an adult who meets the following criteria:

Genotype 1 chronic hepatitis C
Screening laboratory values, test, and physical exam within acceptable ranges

Study Requirements and Duration

If you qualify, you will be randomly assigned (like the flip of a coin) to get either IDX184 or placebo together with Peg-IFN and RBV for 14 days. You will continue to take only Peg-IFN and RBV for the following 14 days.

You will need to be seen in the clinic for up to nine visits during the first 28 days (four weeks) of this study.

After that, you may need to return for occasional study visits for up to 180 days. You could be in the study for as long as 250 days (eight months and 10 days).

ADHD and Obesity in Children

Tue, 05 Jan 2010 10:30:04 -0500

Children between eight and 17 years old who are obese or severely overweight and exhibit behaviors of attention deficit hyperactivity disorder (ADHD) are eligible to participate in this study.

The following behaviors may signal ADHD in your child:

Difficulty following instructions or completing tasks
Forgets to do homework and chores
Doesn’t seem to listen
Easily distracted
Restless or fidgety, can't sit still
Impulsive
Blurts out, interrupts, talks excessively

Study Requirements

This study requires children to attend 13 study visits over six months. They will receive a free evaluation for ADHD and be given free ADHD medication treatment.

The study will be conducted at the Duke Child and Family Study Center in Durham.

Compensation

Families will be compensated for completing all the study visits.

Acceptance-Based, Separated Family Treatment for Adolescent Anorexia Nervosa or a Related Eating Disorder

Tue, 29 Dec 2009 14:33:27 -0500

The aim of the study is to develop and test a family-based intervention that combines established eating disorder treatment components with Acceptance and Commitment Therapy (ACT).

ACT has been found to be useful for other problems, but has not yet been stematically applied to issues of eating and body image.

With this study, we are trying to learn the most effective way to treat an adolescent’s eating disorder and how best to involve parents and caregivers in the process. Because parents and children have different concerns and are struggling with different aspects of the eating disorder, this treatment involves separated family treatment.

Eligibility Requirements

To participate in this study, you must be an adolescent who is:

Between the ages of 12 and 18
Medically stable for outpatient treatment
Diagnosed with anorexia nervosa or a related eating disorder

Study Requirements

Sessions occur on the same day with the same therapist, with adolescents receiving ACT-based individual therapy and parents receiving an ACT-modified version of Off the C.U.F.F parent training curriculum.

Families complete 20 therapy sessions over the course of six months and regular assessments that include questionnaires and interviews throughout the treatment and at a three- and six-month follow-up.

Families are compensated for completing assessments.

This is a collaborative study between Duke University Medical Center and Towson University.