Open Trials from the CFIDS Association Website

Cort

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Studies currently recruiting patients with CFS or related conditions

http://www.cfids.org/about-cfids/clinical-trials.asp

* University of Wisconsin and the Marshfield Research clinics (added 10/5/10)
* Hunter-Hopkins Center (added 7/20/10)
* Fibromyalgia Wellness Project (added 5/12/10)
* The Good Day Bad Day Study (added 5/4/10)
* The TeleHealth Study (added 5/4/10)
* Proteomics of Cerebrospinal Fluid in CFS: Invitation to Healthy Volunteers
(added 3/8/10)
* Gulf War Illness and Healthy Veterans (added 3/8/10)
* Center for Hypotension (added 1/26/10)
* Weill Medical College of Cornell University (added 12/10/09)
* Whittemore Peterson Institute (added 12/10/09)
* Huntsman Cancer Institute (updated 8/09)
* Center for Pediatric Hypotension (updated 8/09)
* New York Medical College Seeks Adolescents with CFS (updated 8/09)

University of Wisconsin and the Marshfield Research clinics

An Exercise Investigation in Chronic Fatigue Syndrome

The University of Wisconsin and the Marshfield Research clinics are conducting a study aimed at understanding the effects of exercise on chronic fatigue in:

Men and Women with Chronic Fatigue Syndrome and Healthy Participants

We are asking for local volunteers to participate in a four-day study with the Exercise Psychology Laboratory on the main campus of the University of Wisconsin, Madison, WI.

We will be assessing blood and biological responses to maximal exercise immediately, 48h and 72h after cycling.

You will receive up to $200.00 for your time and effort.

Call 608-262-2457 if you wish to participate, please leave your name, phone number and mention “Exercise and Chronic Fatigue”

Hunter-Hopkins Center

Hunter-Hopkins Center is evaluating an experimental medication for the treatment of Orthostatic Hypotension (low blood pressure) and Neurally Mediated Hypotension (fainting) in persons with Chronic Fatigue Syndrome.

Persons with CFS and either very low blood pressure or fainting may be candidates for this study and should contact Wendy Fallick, Research Coordinator, at 704 543 9692.

Details of the study can be found at the Clinical Trials website: http://clinicaltrials.gov/ct2/show/NCT00977171?term=droxidopa&rank=6

Fibromyalgia Wellness Project
Sponsored by the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health

Conducted by Collinge and Associates, an independent research organization directed by William Collinge, PhD.

The FM Wellness Project will evaluate a completely individualized approach to symptom reduction for patients with fibromyalgia (FM) and chronic fatigue syndrome (CFS). The goal is to empower patients with uniquely personal insights into what strategies work best for them. Participation involves visiting a website several times each week, about 5-10 minutes each time, to complete the SMARTLog. “SMART” is an acronym meaning Self-Monitoring and Review Tool. Like a diary, the SMARTLog records your activities, treatments, strategies, stresses, other inputs you want to evaluate, and your symptom levels for the past 24 hours. This project is pioneering a new statistical analysis approach that will evaluate participant’s personal data each week to discover patterns of connection between inputs and symptom levels.

For enrollment information, visit http://www.fmwellness.org

The Good Day Bad Day Study
This study is investigating the relationship between immune function and symptom severity. The study involves both those with a diagnosis of chronic fatigue syndrome as well as healthy individuals.

Patients will be asked to come into the university for a total of four visits. During the first visit, you will be asked to fill out questionnaires and receive a complete physical examination. Another assessment will take place when you feel relatively well (Good Day) and another on a day when your symptoms are severe (Bad Day). Then you will be asked to come in for an 18 month follow up. Healthy individuals will also come in for a total of four visits.

All patient volunteers are asked to find a healthy person to participate in the study with them. Spouses and immediate family members are not eligible to participate.

All participants will be paid $20 per visit to cover travel costs.

The study will be conducted at the offices of Dr. Nancy Klimas, 1120 NW 14th Street, Suite 712, Miami, FL 33136.

To register or request additional information please contact: Phones: 305 243-1568 or 305 243-6218. Email: lgarcia2@med.miami.edu or Zbarnes@med.miami.edu.

The TeleHealth Study
This research project is designed to help individuals with Chronic Fatigue Syndrome understand and manage their condition.

Participants will be provided with information about the nature and effects of stress reactions, how to cope and manage stress, and how to take better care of themselves via an innovative home-based program.

To be eligible to participate, participants must be between the ages of 21-65, speak, read and write English fluently, have a telephone line and reside in Dade or Broward counties within the next nine months. Each participant will receive $50 for each completed assessment.

The TeleHealth study is funded by the National Institutes of Health in collaboration with the Behavioral Medicine Research Center at the University of Miami.

For more information, please call: 305-243-1434.

Proteomics of Cerebrospinal Fluid in CFS: Invitation to Healthy Volunteers

"It's all in your head" is taken seriously in this study of central nervous system problems in CFS. Lumbar punctures are performed to obtain the fluid from around the brain. The proteins and neurohormones in this fluid are analyzed for biomarkers and clues about the molecular mechanisms causing CFS. We are grateful to the CFS volunteers who have participated. We would like to invite additional healthy control subjects to participate in order to understand the variations in fluid contents in the general population, and to better understand the changes in CFS.

Genetic material (DNA) will be stored for future XMRV testing. All tests will be done in confidential fashion. We will not be able to provide participants with their personal test results.

Pain and Fatigue Research Alliance
Georgetown University
Washington DC
PI: James N. Baraniuk, MD
Website: www9.georgetown.edu/faculty/baraniuj
Contacts:
cfsresearch@georgetown.edu
gwiresearch@georgetown.edu
Telephone: 202-687-8231

Gulf War Illness and Healthy Veterans

Veterans who were in the Armed Services between August 1, 1990 and July 31, 1991 are invited to a series of studies. Veterans with no CFS-like symptoms, GWI subjects, and veterans with fibromyalgia, irritable bowel syndrome, PTSD, and allied conditions are invited. The different studies include health assessments, exercise studies, lumbar punctures, fMRI brain scans, limited genetic testing, and novel treatment studies.

Genetic material (DNA) will be stored for future XMRV testing. All tests will be done in confidential fashion. We will not be able to provide participants with their personal test results.

Pain and Fatigue Research Alliance
Georgetown University
Washington DC
PI: James N. Baraniuk, MD
Website: www9.georgetown.edu/faculty/baraniuj
Contacts:
cfsresearch@georgetown.edu
gwiresearch@georgetown.edu
Telephone: 202-687-8231

Center for Hypotension

Vascular Dysfunction in Chronic Fatigue Syndrome
– CFS with and without POTS
We are seeking participants who have Chronic Fatigue Syndrome (CFS) ages 15-39 years of age to participate in a New York Medical College IRB-approved (L-8722 and L9729), funded research protocol. The purpose of these investigations is to determine whether the regulation of blood pressure and blood flow causes symptoms of chronic fatigue syndrome. Some patients with CFS can have symptoms such as dizziness and mental confusion when they are kept upright. This is called “orthostatic intolerance.” When upright, some people with CFS may also develop high heart rates along with these symptoms. When this occurs, it is called the postural tachycardia syndrome (POTS). We have proposed that even though some CFS patients do not have POTS, they may still have problems with small blood vessels that can be detected in skin.

When you come for your testing, we will perform a type of tilt testing and other simple noninvasive tests to determine whether you have POTS or not. If you choose to participate, we will use a technique called intradermal microdialysis in which several tiny tubes are placed in the uppermost layer of the skin, while we simultaneously measure blood flow. In addition, we may perform tests to evaluate your ability to do complete mental tasks and combine this with tilt-table testing. You will be reimbursed $150 per day for this testing, which may take place over several days.

Further details of the research and representative consent forms can be found on our web-site, syncope.org

If interested, please reply to:
Courtney Terilli, Research Coordinator
The Center for Hypotension
Department of Pediatrics
19 Bradhurst Avenue, Suite 1600 South
Hawthorne, New York 10532
courtney_terilli@nymc.edu; telephone 914-593-8888
or
Julian Stewart, M.D., Principal Investigator
stewart@nymc.edu; telephone 914-593-8888
or
Marvin S. Medow, Ph.D., Principal Investigator
marvin_medow@nymc.edu, telephone 914-593-8888

Weill Medical College of Cornell University

Volunteers for a magnetic resonance imaging (MRI) research study in chronic fatigue syndrome (CFS)


Men or women of any race, age 18 to 45 years, who have been diagnosed with CFS, and would be willing to undergo

* A work up and evaluation for CFS symptoms.
* Brain scans for lactic acid imaging by MRI at Citigroup Biomedical Imaging Center of Weill Cornell Medical College in New York City. Each scan will take 90-120 minutes to complete.

Up to $100 in compensation will be available for participation.

If you would like to paticipate, please call Ms. Mao at 212-746-2632 (if you reach a recorded message, please leave a DAYTIME TELEPHONE NUMBER where you can be reached) for a short telephone interview.

IRB PROTOCOL NUMBER #0407007324; approved 5/26/09

Click here for a PDF version of this IRB-approved recruiting flyer.

Whittemore Peterson Institute

New treatment strategies for immune modulation and antiviral strategies have been successfully developed for chronic inflammatory disease over the last decade. Each of these drugs has had to undergo extensive investigation before obtaining approval for general use.

A critical need is sub grouping the spectrum of neuro-immune disease in order to stratify patients according to the appropriate therapy. The current translational and clinical research studies at WPI have clinical trials as endpoints. While WPI currently has no open clinical trials, when trials are initiated they will offer patients the opportunity to participate in clinical trials that are designed to test the effectiveness of new forms of therapy. Clinical trials are voluntary, and our team will only involve patients who are entirely comfortable with the process.

Another critical need is a comprehensive database of patients with information on your diagnosis, conditions, family health and similar items. You can help by completing the research questionnaire and including your information for our researchers to study. All clinical trials conducted here at WPI are approved and closely monitored by the University of Nevada's Institutional Review Board (IRB). No WPI staff have any financial interests or holdings in the various pharmaceutical companies who produce drugs used to treat chronic diseases.

If you would like to be considered for participation in current or upcoming clinical trials, and include your information in our research database, please complete this research questionnaire.

For more information, please contact:

Research Program Coordinator
Whittemore Peterson Institute
6600 N. Wingfield Parkway
Sparks, NV 89436
patientinfo@wpinstitute.org

Huntsman Cancer Institute

Participants wanted for study of chronic fatigue


Individuals who have had severe, unexplained fatigue for at least six months and who have no serious abnormalities on medical tests are wanted for a study of chronic fatigue. Patients who qualify for the study will be asked to complete three questionnaires over a six month period. Participating in the study will not alter the treatment that your physician gives you. The purpose of the study is to evaluate whether patients treated by certain types of physicians improve faster than patients treated by other types of physicians. Patients do not need to live in the Salt Lake City area. Questionnaires will be mailed to study participants or can be completed online.

If you are interested in participating, please contact the study coordinator, Kathleen O’Connor, Huntsman Cancer Institute in Salt Lake City, UT, by phone (801) 587-4741 or email kathleen.oconnor@hci.utah.edu for more information.

Center for Pediatric Hypotension
VASCULAR DYSFUNCTION IN CFS


Researchers at the Center for Pediatric Hypotension at New York Medical College in Valhalla NY have received funding from the National Institutes of Health (NIH) to study whether circulatory problems explain the symptoms and signs of the chronic fatigue syndrome in teenagers. Principal Investigator is Julian M. Stewart MD, PhD, and Professor of Pediatrics and of Physiology at New York Medical College.

The overall objective of the study is to determine the biochemical mechanisms of CFS/POTS (postural tachycardia syndrome) as they relate to changes in nitric oxide and angiotensin, and to explore the possibility of subclinical, microvascular abnormalities in those CFS patients without POTS. If POTS is present they will also test medications used for treating POTS which may help teenagers with CFS.

They are seeking patients aged 15-29 years old patients with chronic fatigue syndrome (CFS) with or without any overt form of cardiovascular or circulatory disease. Details on this study can be found at www.syncope.org.

For further information please contact the Study Coordinator:
Courtney Terelli, BS, RN.
Nurse Research Coordinator
Valhalla, NY
914-593-8888
Courtney_Terelli@NYMC.edu

New York Medical College Seeks Adolescents with CFS

Sponsored by: National Institutes of Health
Principal Investigator: Julian Stewart, MD
Center for Pediatric Hypotension
New York Medical College
Valhalla, N.Y.
Telephone: 914-594-4370

CFS patients ages 13-19 are being recruited for a NIH-funded study investigating the hypothesis of circulatory dysfunction in CFS. Recent investigations indicate that most teenagers with CFS have a form of chronic orthostatic intolerance (the inability to remain upright without symptoms) called the postural tachycardia syndrome (POTS), which impairs blood flow and heart rate, and sometimes causes a fall in blood pressure. These patients have symptoms of chronic orthostatic intolerance including dizziness, fatigue, nausea, headache, pallor and neurocognitive loss (difficulty thinking), which overlap with the case definition of CFS. Our study will determine how often POTS occurs, the mechanism(s) of POTS in individual patients and the effectiveness of a medication used for treating POTS in adolescents with CFS. For more information, see the study website.

Other listings for Clinical Trials

* ClinicalTrials.gov is the National Institutes of Health's database with information on more than 4,000 federal and private medical studies involving patients at more than 47,000 locations nationwide. Center Watch Clinical Trials Listing Service lists more than 41,000 industry- and government-sponsored clinical trials, as well as new drug therapies recently approved by the FDA.
* Current Controlled Trials is a multi-national effort to provide information about thousands of research studies worldwide.

Resources For Those Considering Enrolling in a Study
Here are some resources to help you evaluate whether participating in a research study is right for you. Please consult with your personal physician about such matters for further information.

* Clinical Trials Fact Sheet for Women - From the National Women's Health Information Center
* OHRP Informed Consent Frequently Asked Questions - Published by Office for Human Research Protections (OHRP)
* Clinical trials: from centerwatch - what do they offer the volunteer.

Last updated 10/5/2010