DukeHealth.org: Duke Clinical Trials

Medication Study in Patients with Bipolar Depression

Mon, 23 Jan 2012 14:44:36 -0500

People between the ages of 18 and 65 who have been diagnosed with bipolar 1 and are currently in a depressive state are needed to participate in a clinical study.

The study is 11 weeks and includes eight total visits. At the completion, participants will be reimbursed $280 for time and travel.

We are testing the effects of a new investigational drug, Cariprazine, for bipolar depression. The study drug and psychiatric and physical assessments will be provided free of charge.

Do You Startle Easily?

Mon, 23 Jan 2012 12:44:37 -0500

Are you often distracted by noises around you?

Our study examines the effects of meclizine, a drug found in many over-the-counter allergy medicines, on how people react to different sounds.

Participants between the ages of 18 and 40 are needed for the study.

Male participants who qualify will come to the lab for up to four separate three-hour appointments and may earn up to $250.

Female participants who qualify will attend only one appointment and be compensated $25.

Appointments take place at Duke University’s Civitan building in Durham.

Renal Denervation in Patients with Uncontrolled Hypertension -- SYMPLICITY HTN-3

Thu, 19 Jan 2012 14:59:29 -0500

The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in research participants whose blood pressure is not controlled, despite treatment with multiple blood pressure medications.

Participants are considered for this study after their doctor determines that their blood pressure is not controlled with medications.

In addition to current blood pressure medications, participants may undergo a procedure using a medical device that delivers low-level radiofrequency (RF) energy through the wall of the blood vessel to the kidney (renal artery) to disrupt the nerves that lead to the kidney.

Eligibility Requirements

To be eligible to participate in this trial, participants must meet the following requirements:

Be between the ages of 18 and 80 years old at the time of randomization
Receive a stable medication regimen including full, tolerated doses of three or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of two weeks prior to screening) that is expected to be maintained without changes for at least six months
Have a systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of three blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
Agree to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study

Imaging Decision-Making

Thu, 19 Jan 2012 13:35:35 -0500

Smokers are needed for research study on decision-making.

Healthy, drug-free, right-handed participants between the ages of 18 and 55 will be scheduled for two study visits.

No experimental medications are involved.

Compensation is up to $135.

Diabetes Food and Mood Study

Fri, 13 Jan 2012 15:48:23 -0500

Many patients with type 1 diabetes tell us that managing their weight and their diabetes is difficult and sometimes frustrating.

The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight.

Eligibility Requirements

You may be eligible to participate in this study if you:

Are between the ages of 18 and 65
Have been diagnosed with type 1 diabetes

Study Requirements

If you choose to participate, you will first speak with one of our research coordinators. This initial screening call generally takes about 20-30 minutes. After you have completed the screening, the research coordinator will send your results for review and someone will call you within 24-48 hours to let you know if you qualify.

The study involves a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for three days.

The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete.

You will also be asked to call in and answer study questions after eating.

The study involves a minimum of two clinic visits to Duke.

Compensation

Compensation starts at $175. You will receive an additional $75 for answering 95 percent or more of the calls you receive, for a total possible $250.

Meningococcal B Disease Vaccine Study in Children 10 to 12 Years Old

Fri, 06 Jan 2012 14:51:25 -0500

Healthy children may be eligible to participate in a research study evaluating an investigational meningitis vaccine and other serious infections caused by the meningococcus B germ.

Qualifying participants receive compensation for time and travel for completed visits.

Eligibility Requirements

Your child may be eligible for this study if he or she is:

Healthy
10 to 12 years old
Available for six study visits over a 14-month period
Without any chronic illness
Has never had the Menactra® vaccine
Has not had the TdaP vaccine within the last five years

Meningococcal B Disease Vaccine Study in Children 11 to 17 Years Old

Fri, 06 Jan 2012 14:39:31 -0500

Healthy children may be eligible to participate in a research study evaluating an investigational vaccine to prevent meningitis and other serious infections caused by the meningococcus B germ.

Qualifying participants receive compensation for time and travel for completed visits.

Eligibility Requirements

Your child may be eligible for this study if he or she is:

Healthy
Between 11 and 17 years old
Available for five study visits over a 14-month period
Without any chronic illness/illnesses
Never received the human papilloma virus vaccine (Gardasil)

A Pilot Study Using Functional Neuroimaging To Assess Cognitive Function After Cardiac Surgery

Wed, 28 Dec 2011 15:11:58 -0500

Cognitive impairment occurs frequently in seniors and older adults undergoing cardiac operations.

Post-operative cognitive decline (impairment in memory, attention, and thinking) is present in over one third of patients at six weeks after surgery and persists in a larger number of patients up to five years after surgery. This decline in cognitive function leads to a reduction in quality of life for both the patient and the patient’s family.

The primary purpose of this study is to determine the frequency and nature of brain changes associated with cognitive decline in patients undergoing cardiac surgery. Brain changes will be detected by magnetic resonance imaging (MRI) and tests of attention, memory, and concentration.

A total of 55 subjects 50 years old or older will be enrolled in this research protocol -- 29 undergoing cardiac surgery and 26 with cardiovascular disease not requiring surgery.

Subjects will be compensated a total of $171 to cover time and expenses. Participation requires three three-hour study visits; one at baseline, one at six weeks and another one year after baseline.

Guidelines for Flying After Diving

Wed, 14 Dec 2011 15:48:09 -0500

The Flying After Diving Study is designed to evaluate the effect of altitude exposure following diving on the production of circulating bubble production and/or the development of decompression sickness.

Study Details

This study involves a single, dry resting chamber dive to 60 feet of seawater for 55 minutes followed by a specific surface interval and then a simulated flight to 8,000 ft (the maximum cabin altitude allowed in commercial, pressurized aircraft) for four hours.

All phases are conducted at the Center for Hyperbaric Medicine and Environmental Physiology (Hyperbaric Center) in Duke University Medical Center.

Studies are normally scheduled on one evening and the following day during the week.

Eligibility Requirements

Participants must be 18 to 60 years of age and certified divers or experienced in hyperbaric environments.

Compensation

Participants will receive pro-rated compensation for a total of $120 per trial.

Gene Profiling of Decompression Stress

Wed, 14 Dec 2011 10:37:08 -0500

Divers, or those with previous hyperbaric exposure experience, are needed for a study of changes in gene expression that may indicate decompression stress. Subjects will undergo Doppler ultrasound and blood will be drawn for gene testing.

Eligibility Requirements

Subjects must be between the age of 18 to 60 years old and have no physical impairment that would prevent them from diving.

Prior to the study, female subjects will be given a pregnancy test. If you are pregnant, you will not be able to participate.

Compensation

Subjects are compensated up to $200 for completing the experimental day.

This study is part of the larger U.S. Navy Diving Research Study.

A Research Study for Patients with Gout

Mon, 05 Dec 2011 14:24:59 -0500

The purpose of the study is to assess the safety, tolerability, and serum urate-lowering effect of an investigational drug, Levotofisopan, in patients with gout.

Eligibility Requirements

To participate in this study, you must be between the ages of 18 and 65 and have been diagnosed with gout.

You must have had a gout flare within six months or have a chronic swollen joint due to gout.

Study Requirements

The study requires a 10-day admission to DCRU and one follow-up vist.

Duration

The study will last approximately five weeks.

Compensation

Compensation for participation is up to $3,200.

A Pilot Study to Evaluate Regional Lung Function in Normal Subjects and Subjects with Airway and Lung Disorders Using 1H MRI with Oxygen as a Contrast Agent

Tue, 29 Nov 2011 15:57:11 -0500

The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.

This is an open label study with up to 60 subjects with diagnosed lung airway disease and up to 20 normal control subjects.

A subset of subjects (five control subjects and five subjects with lung disease) will be scanned at a second time point (between weeks one and four) after the initial scan for reproducibility determination.

Eligibility Requirements

Subjects must be 18 years of age or older.

Duration

This study takes place over two days unless you give consent to be in the sub study.

Impulsivity and Behavioral Risk in HIV Patients with Mood Disorders

Tue, 22 Nov 2011 13:09:10 -0500

Seeking HIV-positive adults for a research study (Durham, NC).

Researchers at Duke University are conducting a study on impulsivity, HIV/AIDS, and mood disorders like depression or bipolar (manic-depression).

If you qualify, you could earn up to $75 for two study visits!

You may be eligible if you are:

18 years old or older
HIV-positive

Your participation is strictly voluntary and confidential.

Neurobehavioral and fMRI Research in HIV Infection and Cocaine Dependence

Tue, 22 Nov 2011 13:04:50 -0500

Seeking HIV-positive adults for a research study.

Researchers at Duke University Medical Center in Durham, NC, are conducting a study on HIV/AIDS and cocaine use. If you qualify for participation, you could earn up to $180 for three study visits.

Eligibility Requirements

You may be eligible to participate if you are:

18 years or older
HIV-positive
Currently use crack cocaine

Your participation is strictly voluntary and confidential.

Treatment Experienced Bristol-Meyers Squibb (BMS) Study

Tue, 22 Nov 2011 12:48:25 -0500

This is a phase IIb randomized, controlled, partially-blinded trial to investigate safety, efficacy, and dose-response of BMS-663068 in tx experienced HIV-1 subjects, followed by an open-label period on the recommended dose.

There will be five treatment groups, randomized 1:1:1:1:1 (50 in each group). Study is partially blinded through week 24 (for all subjects).

Stage 1 is 96 weeks in duration. Stage 2 extends the study to acquire longer-term safety and efficacy data. The post-dosing follow-up phase is 24 weeks in duration.

Treatment group 1: BMS-663068 400 mg BID + Ralt + TDF
Treatment group 2: BMS-663068 800 mg BID + Ralt + TDF
Treatment group 3: BMS- 663068 600 mg QD + Ralt +TDF
Treatment group 4: BMS- 663068 1200 mg QD + RAlt + TDF
Treatment group 5 (reference group): ATV/r 300/100 mg QD + Ralt +TDF

Inclusion Criteria

HIV RNA > 1,000
Treatment experiencedSusceptibility to study drugs
CD4 > 50

Exclusion Criteria

Chronic hep B / hep C
History of resistance to any component of the study regimen (TDF, ATV, RAL)

All HIV medications areprovided through study.