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Hello current and future volunteers! What better way to celebrate the summer than by reading the next edition of the “Participating in NIH Research” newsletter. All of us at the NIH patient recruitment department wish you a happy and healthy summer.
Mood and Anxiety Disorders
Study Number: 04-M-0270
Serotonin, one of the brain’s natural chemicals, connects with receptors on brain cells to regulate emotion, anxiety, sleep, stress hormones, and other body functions that are disturbed in various mood and anxiety disorders. This study will examine the role of serotonin function in the brain. The research will also look at the function of particular brain areas, how they are involved in regulating emotions, and how serotonin is involved in the regulation of their function.
Participants: People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study: Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time and the destination), having a destination between 30 and 50 latitudes (approximately Cairo to London), taking an evening flight (5 PM to midnight) with morning arrival, and remaining abroad at least 4–10 days.
Jet Lag
Study Number: 05-CH-0037
Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones. The cause of jet lag is not known, but various hormones, including cortisol and melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's internal rhythms. This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. This study will test whether taking cortisol, melatonin, or both can help re-establish the body's day-night cycle and result in less jet lag.
Participants must be: People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study: Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time and the destination), Have a destination between 30 and 50 latitudes (approximately Cairo to London), Taking an evening flight (5 PM to midnight) with morning arrival, and remaining abroad at least 4–10 days.
Tongue Study
Study Number: 01-CC-0044
More information on the structure and function of the human tongue is needed to develop better treatments for people with certain diseases affecting speech and swallowing. This study will use magnetic resonance imaging (MRI) and ultrasound to examine changes in tongue volume and blood circulation during tongue exercises that require the use of different tongue muscle movements and contractions.
Participants must be: between 21 and 80 years old and live in the metropolitan Washington, D.C. area. Candidates will be screened with a brief medical history and physical examination, including suitability for MRI testing, and a brief examination of tongue, lip and jaw movements.
Patients will undergo: ultrasound and MRI studies. During both tests, they will perform tongue exercises, such as holding a soft round object on the tongue or exerting tongue pressure against the back of the throat or roof of the mouth. During the ultrasound, the subject lies on a flattened dental chair. A small transducer is placed under the chin to take images of the tongue during the exercises. A thin rubber strip with air-filled pressure bulbs is attached to the roof of the mouth (with dental adhesive) to measure tongue pressure.
Aptamer-RNA Target to Factor IXa
Study Number: 05-H-0164
Patients with heart attacks and other conditions require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine, in normal healthy subjects, how the REG1 system works and is eliminated from the body.
Patients will undergo the following tests and procedures: Day 1 patients are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample. Day 2: A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples. Days 3 and 7: A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.
More Clinical Trials
Search for more examples of clincal trials for healthy volunteers at http://clinicalstudies.info.nih.gov/. Please type the word “Healthy” for a full listing of Healthy Volunteer opportunities.
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 Dr. Solomon’s clinical and research interests involve issues important to both Critical Care Medicine and Cardiovascular Diseases. In addition to his work with the NIH MICU (Medical Intensive Care Unit) patient population, Dr Solomon has clinical and research collaborations with local heart failure and transplant programs. He focuses on translational research, and his desire is to utilize advanced techniques developed at NIH. His current research efforts involve using advanced cardiac MRI perfusion imaging techniques to determine if the inflammatory reactions involved in the myocardial depression of sepsis and transplant coronary vasculopathy produce a quantifiable microvascular injury.
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Q: How long have you been working with Healthy Volunteers in your studies?
A:This will be the first time recruiting Healthy Volunteers but we are really looking forward to working with them in our studies.
Q: Is your focus primarily adult or pediatric?
A: Adult. The youngest we work with is 18 year olds.
Q: How many healthy volunteers do you usually work with every year?
A: We are recruiting 10 for the pilot and hoping for 85 total for the study.
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Q: Why do you think that Healthy Volunteers are so important for research medicine?
A:Physicians can’t possibly understand what is “unhealthy” without a proper understanding what “healthy” is. Healthy volunteers make that possible.
Q: What is your motto regarding research?
A: There is a Hebrew Word, “Tikkun Olam,” that when translated means can be translated as “repairing the universe" or "fixing the world.” This is what I think of when I remember why I became a doctor. My research and training is my own chance to try to make people’s lives and society better.
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The Patient Recruitment and Public Liaison Office (PRPL) is part of the Clinical Center at the National Institutes of Health. NIH is the federal government’s biomedical research agency and one of the world's leading medical research organizations. PRPL staff members assist patients, their families, and physicians by providing information about participating in research studies being conducted at the Clinical Center, the NIH research hospital in Bethesda, Maryland.
For More Information About Participating in Clinical Research
Phone: 1-866-444-6676
TTY: 1-866-411-1010 (toll free)
E-mail: prpl@mail.cc.nih.gov
Web: www.cc.nih.gov/participate.shtml
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| Lyme Disease |
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| Although it’s spread by ticks which are only slightly bigger than the period at the end of this sentence, Lyme disease can cause big problems if not treated quickly enough. |
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| Today, cases of Lyme disease have been identified in nearly all 50 states, but the vast majority of breakouts occurs in the Northeast, as well as in Wisconsin and Minnesota. And while the symptoms of Lyme disease can mimic other conditions, it can be diagnosed and treated fairly easily by a doctor who recognizes the signs. |
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| So how do you protect yourself this summer? The best precaution against Lyme disease is to avoid contact with soil, leaf litter and vegetation. However, if you do garden, hike, or camp, or know that you are going to be outdoors for a long period of time, there are a few precautions you can take to help keep you safe: |
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Wear enclosed shoes and light colored clothing with tight weave to spot ticks easily. |
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Scan clothes and any exposed areas frequently while outdoors. |
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Stay on cleared, well-traveled trails. |
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Use insect repellent containing DEET (Diethyl-meta-toluamide) on skin or clothes. When applying, avoid the child's hands so he or she won't ingest deet. |
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Avoid sitting directly on the ground or on stone walls (havens for ticks and their hosts). |
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Keep long hair tied back. |
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What is General Ultrasound Imaging?
Ultrasound imaging, also called ultrasound scanning or sonography, is a method of obtaining images from inside the human body through the use of high-frequency sound waves. The reflected sound wave echoes are recorded and displayed as a real-time visual image. No ionizing radiation (x-ray) is involved in ultrasound imaging. Obstetric ultrasound refers to the specialized use of sound waves to visualize and thus determine the condition of a pregnant woman and her embryo or fetus.
Ultrasound is a useful way of examining many of the body's internal organs, including but not limited to the heart, liver, gallbladder, spleen, pancreas, kidneys and bladder. Because ultrasound images are captured in real time, they can show movement of internal tissues and organs and enable physicians to see blood flow and heart valve functions. This can help to diagnose a variety of heart conditions and to assess damage after a heart attack or other illness.
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