Please complete the information requested below. You will be prompted to answer
several questions assessing your medical condition in order to determine your eligibility
for participation in this research study.
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Has your doctor told you that you have a diagnosis of ulcerative colitis? |
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Are you currently taking oral 5-aminosalicylates (5-ASAs) (eg., Asacol, Salofalk)
OR corticosteroid pills (e.g., Cortone-cortisone, Deltasone-prednisone, Cortef-hydrocortisone),
OR Purinethol (e.g., 6-MP, 6-mercaptopurine), OR Imuran (azathioprine)?
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Do you have a history of failing or not tolerating treatment with at least one
of the following therapies: oral 5-aminosalicylates (5-ASAs) (eg., Asacol, Salofalk)
OR corticosteroid pills (e.g., Cortone-cortisone, Deltasone-prednisone, Cortef-hydrocortisone),
OR Purinethol (e.g., 6-MP, 6-mercaptopurine), OR Imuran (azathioprine)? |
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The study requires a screening sigmoidoscopy and a follow-up sigmoidoscopy at
the end of six weeks. Would you accept this requirement? |
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Do you have any history of tuberculosis (TB)? |
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Have you had an intestinal operation known as an ostomy, colostomy, or "colostomy
bag"? |
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Have you had a fistula, which is an abnormal connection between organs? |
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Have you had abdominal surgery in the past 2 months? |
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Have you ever taken any of the following medications: |
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In the past 12 months, have you taken any of the following medications? |
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In the past 2 months, have you taken any of the following medications:
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Are you post-menopausal (i.e. > 12 months without a menstrual period), or
surgically sterile? |
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Are you currently nursing, pregnant, or planning to become pregnant in the next
6 months? |
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Are you or your partner willing to use an acceptable birth control method such
as abstinence, birth control pills, hormonal methods (implants or patches), intrauterine
device, or barrier method with spermicide during the study and for 6 months after
your last study treatment? |
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Have you had ongoing, chronic, or recurring infections
(chronic chest infection, sinusitis, or recurrent urinary tract infection)? |
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Have you had an ongoing, chronic or recurring open, draining, or infected skin
wound? |
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In the past year, have you had a BCG (Bacille Calmette-Guerin) vaccination? |
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In the past 3 months, have you had a live vaccine such as
Flumist (intra-nasal flu vaccine)? |
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In the past 3 months, have you had a chest X-ray showing any abnormality such
as cancer or an infection? |
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In the past 2 months, have you been hospitalized or treated with IV antibiotics
for an infection? |
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Have you had any of the following:
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Have you been treated for an opportunistic infection such as pneumocystis pneumonia
or fungal infections of the lung or blood within the past 6 months? |
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In the past 3 years, have you had a substance or alcohol abuse problem? |
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Have you participated in another drug research study within the past 4 weeks? |
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