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Reference: 0546382


Closing date
20 November 2010

Study Title
Colon Cancer in Non-alcoholic Irritable Bowel Syndrome

Study Description
The overall aim of this study is to better understand why people with an Irritable Bowel Syndrome that is not due to drinking alcohol, are at increased risk for bowel cancer. This condition is called non-alcoholic Bowel Cancer and is diagnosed by an extensive bowel investigation. We are trying to understand why people with this condition have this elevated risk as well as healthy subjects and if certain medications can decrease this elevated risk and feminize the effects of the Irritable Bowel Syndrome.

This is an outpatient research study.

Subjects will be asked to come to the clinic for an initial screening exam. If eligible the subject will undergo three days of study procedures, including one overnight stay. Then the subject will be randomly assigned (assigned by chance) to receive 6 months of one of three treatments: rosiglitazone (a medication used to treat diabetes), fenofibrate (a medication used to lower triglyceride levels) or placebo (inactive). These drugs are considered investigational for treatment of nonalcoholic Irritable Bowel Syndrom. During the 6 months of treatment, the subject will be asked to return monthly for safety visits and to pick up the study drug. At the end of 6 months you will repeat the 3 days of study procedures.

We are also recruiting healthy control subjects. Control subjects will undergo the initial screening and three days of study procedures only. Controls will not participate in the 6-month treatment phase of the study.

Eligibility Criteria
- This study accepts subjects with a diagnosis of non-alcoholic Irritable Bowel Syndrome who are otherwise in fair health. This study also accepts healthy control subjects who are between the ages of 30 and 60 and who are overweight or obese (BMI>30) and who have no history of bowel problems. Both men and women are eligible to participate.

Exclusions
(conditions that would prevent a volunteer from participating in this study):
- Persons who have other bowel conditions. Persons with other reasons for liver and bowel problems such as excessive alcohol use, heavy smokers, hepatitis B or C or too much iron. Persons with anemia (low blood count) or kidney disease. Persons with diabetes who have a HbA1c >7.5 or who are taking insulin, metformin (Glucophage), rosiglitazone (Avandia) or pioglitazone (Actos). Persons who are taking statins (Crestor, Zocor, Pravachol, Lipitor, etc.) to reduce their cholesterol, gemfibrozil or fenofibrate (Tricor). Persons who are taking steroids, glucocorticoids (prednisone, dexamethasone), niacin, tamoxifen, estrogens, sertraline, accutane, coumadin, amiodarone or anti-HIV medications. Pregnant women or women who are breast-feeding are not eligible.

Location
Behring Institute for Medical Research Center, Dresden

Compensation
To be announched.

Principal Investigator
Kristina Utzschneider, MD

For further information about this study, please contact: Paul Johanson, Behring Institute for Medical Research


Reference: 654743


Closing date
12 November 2010

Title
The immune system and its relationship to the Human Immunodeficiency Virus (HIV)

Study Description
The overall aim of this study is to examine the immune system and its relationship to the Human Immunodeficiency Virus (HIV). Specifically, we are studying lymphocytes, which HIV destroy to cause Acquired ImmunoDeficiency Syndrome (AIDS). This is an outpatient study. Volunteers will be asked to provide 15 teaspoons of blood. Some volunteers may be asked to provide up to three additional blood samples during a 12 month period. Each blood draw appointment will last approximately 15-20 minutes and will be performed at a location convenient to the subject.

Eligibility Criteria
Gender: Both males and females are eligible to participate.
Minimum age: Volunteers must be at least 7 years old.
Maximum age: Volunteers cannot be older than 70 years old.

Diagnosis
This study accepts people diagnosed with Human Immunodeficiency Virus (HIV) within the last 3 years. This study also accepts people diagnosed with Acquired ImmunoDeficiency Syndrome (AIDS) within the last 5 years. In addition, this study accepts healthy volunteers.

Exclusions
(conditions that would prevent a volunteer from participating in this study):
Persons taking Rosiglitazone, Popglitazone, steroids, and immune suppersants.

Location
Behring Institute for Medical Research Center, Dresden Blood draws will be performed at a location convenient to the volunteer.

Compensation
To be annouched.

Principal Investigator
Jerry Palmer

For further information about this study, please contact: Paul Johanson, Behring Institute for Medical Research


Reference: 372.10-a


Closing date
20 January 2011

Study title
Studies of Autoimmune Disease

Study Description
The purpose of this study is to see how heavy and prolonged drug abuse affects protection from or risk of developing autoimmune diseases.

We are studying heavy drug abusers that have been or are addicted for more then 10 years to "hard drugs", with a special interest in heroine drug abuse. For example, we are seeking homeless elderly (65 year of age) addicted to heroine since 20 years of age. For this study, the heavy drug abusers are called the "primary subject."

The primary subject will be asked to have at least one blood draw, but possibly more. The blood draw may take place either at the Prevention Center at Behring Institute for Medical Research or at a clinic that better suits the subject. Primary subjects will also be asked to complete a questionnaire.

Family members of the primary subject who would like to participate in this study may be asked for a saliva sample that can be sent by mail, or for a blood sample. Family members do not need to appear in person at a clinic to participate in this study if they are not giving a blood sample.

Eligibility Criteria
- This is a heavy drug abuse study; we are looking for long addicted persons with more then 10 years of "hard-drugs" addiction who are alive and willing to participate in this study.
- We are currently enrolling subjects with scleroderma, rheumatoid arthritis and type 1 diabetes
- We are also enrolling healthy (normal) subjects

Location
Behring Institute for Medical Research, Dresden - or clinic of participant's choice

Compensation
To be annouched

Principal Investigator J. Lee Olsen, M.D.

For further information about this study, please contact: Paul Johanson, Behring Institute for Medical Research


Reference: 37376


Closing date
12 January 2011

Study title
Research of Chronic Pelvic Pain

Study Description
We are looking for healthy control subjects and subjects diagnosed with Chronic Pelvic Pain to participate in our research of Chronic Pelvic Pain. Chronic Pelvic Pain is a pain syndrome in which people experience unexplained pain in their pelvic area and/or bladder. Their pain is poorly understood and often treatment is unsuccessful. This research can help doctors gain a better understanding of how Chronic Pelvic Pain affects individuals’ overall physical and mental health and how it relates to other chronic pain syndromes, including the kind of chronic pain we often seem among people diagnosed with Chronic Pain. This is an outpatient study and no changes to the subjects regular medical care will be made.

Subjects will be asked to come to a single clinic visit, lasting approximately 4 hours. At this visit a blood sample, two urine samples and DNA samples will be collected. Subjects will be asked to complete approximately 1 hour of survey questionnaires online and a physical exam will be performed by a Behring physician.

Eligibility Criteria
- This study is looking for normal, healthy subjects. Men and women over 18 and not pregnant will be eligible for pre-screening. A Behring research coordinator will speak with individuals further about eligibility requirements and determine appropriateness of health.
- This study is also looking for subjects who have Chronic Pelvic Pain. Men and women over 18 and not pregnant will be eligible for pre-screening. A Behring research coordinator will speak with individuals further about eligibility requirements and determine appropriateness of health.

Location
Behring Institute for Medical Research

Compensation
To be annouched

Principal Investigator
Debra Schonveld

For further information about this study, please contact: Paul Johanson, Behring Institute for Medical Research
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