Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.


Options:
A: * INCLUSION CRITERIA:

To be eligible for the study each participant must have at least one eye, which satisfies all ocular inclusion criteria:

1. Participants with type 1 or 2 diabetes.
2. Participants with clinically significant macular edema in at least one eye that requires laser treatment, but in the opinion of the Investigator, can be delayed for up to at least 3 months.
3. Best corrected visual acuity 20/400 or better as measured on an ETDRS chart in the eye with clinically significant macular edema; this eye will be considered they study eye. If both eyes have clinically significant macular edema and best corrected visual acuity greater than or equal to 20/400, the right eye will be considered the study eye, however, both eyes will be eligible for treatment.
4. May have had proliferative diabetic retinopathy but scatter photocoagulation must have been performed more than four months ago.
5. Ocular media sufficiently clear to allow for quality fundus photography.
6. If aphakic or pseudophakic, lens removal must have occurred at least 6 months prior to enrollment.
7. Documented hemoglobin A1C 12% or less within one month of baseline.
8. Willingness to accept randomization for diet or drug therapy for lowering of elevated lipid levels (for sites participating in the Lipid Lowering study option).
9. Understand and sign the informed consent.
10. Participants 18 years of age and older since the population of interest is primarily adults.

EXCLUSION CRITERIA:

To be eligible for the study, each participant must not satisfy an ocular exclusion cirterion in both eyes.

1. Retinopathy that requires scatter photocoagulation immediately.
2. Ocular disease other than diabetic retinopathy that may confound the outcome of the study (e.g. age-related macular degeneration, drug toxicity, uveitis, etc.).
3. Prior of current macular detachment in the eligible eye(s).
4. Use of an investigational drug within 30 days of enrollment.
5. Malaborsorption syndrome.
6. Concurrent administration of the anti-obesity drug orlistat (Xenical).
7. Positive serum pregnancy test or currently lactating for women of childbearing potential.
8. Chronic requirement (e.g., greater than or equal to 4 weeks at a time) for ocular medication for diseases that, in the judgement of the examining physician, are vision thereateniong or may affect the primary outcome (artificial tears are permitted).
9. History of cancer and prognosis of survival of less than 3 years.
10. Participants whose diabetic macular edema, in the opinion of the Principal Investigator, cannot benefit from laser treatments, including those with subretinal fibrosis, severe macular non-perfusion, or parafoveal leakage in oth eyes.
11. Participants that have a history of focal laser treatment, and in the opinion of the investigator are thought to be refractory (e.g., \> 50 micron burns or equivalent) to laser treatment or wwere treated within 3 months of baseline.
12. Participants with clear vireal-retinal tracion wiich in the opinion of the investigator needs to be treated as a contributor macular edema.
13. Participants requiriing herapy with topaical ophthalmic prostaglandin analogues.
14. Laboratory values outside normal limits and considered clinically significant by the investigator.
15. Past or current liver disease, which precludes the use of the lipid-lowering drugs.
16. Used Celebrex \[Registered Trademark\] or any other COX-2 inhibitor, NSAIDs, or ocular topical NSAID use great than 3 days per week for a period of 4 weeks or more within 6 months prior to enrollment, or likely need during the study (Aspirin dose of 325 mg per day is permitted).
17. Concurrent warfarin therapy or known bleeding diathesis.
18. Concurrent lithium therapy.
19. History of peptic ulcer disease within 1 year prior to enrollment.
20. History of kidney disease (serum creatinine greater than 2.5 mg/dL, or need for dialysis).
21. Allergy to sulfa- containing compounds, NSAIDs, or demonstrtion of the aspirin triad.
22. History of inflammatory bowel disease.
23. History of mycardial infarction within 2 years prior to enrollment.
B: DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal adenomatous polyps
* Meets the following criteria by colonoscopy (performed within the past 6 months):

  * Cecum was totally visualized or reached
  * At least 90% visualization of colon surface area
  * Removed at least 1 adenomatous polyp of at least 3 mm in size during procedure (For the Advanced Adenoma Sub-study: Removal of at least 1 advanced colorectal adenomatous polyp during procedure. An adenoma is considered advanced if it is 10 mm or greater in size, and/or has villous histology and/or shows high grade dysplasia)
  * Removed no more than 10 adenomatous polyps of any size by endoscopy
  * All other neoplastic and non-neoplastic colon polyps must have been completely removed (except for diminutive \[less than 3 mm\] sessile rectal polyps)
  * For the sub-study, at least 1 advanced adenomatous polyp defined as 10 mm or greater in size and/or has villous histology and/or shows high grade dysplasia
* No prior diagnosis of any of the following:

  * Colorectal cancer
  * Familial adenomatous polyposis
  * Ulcerative colitis
  * Crohn's disease
  * Hereditary non-polyposis colon cancer (HNPCC), defined as:

    * Histologically confirmed colorectal cancer in at least 3 relatives, 1 of whom is a first-degree relative of the other 2
    * Disease occurrence in at least 2 consecutive generations
    * Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age

      * Patients with a family history of colorectal cancer but who are not diagnosed with HNPCC are allowed
* No more than 1 prior segmental colon resection

PATIENT CHARACTERISTICS:

Age

* 40 to 80

Performance status

* SWOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Hemoglobin \> 11 g/dL
* WBC 3,000 - 11,000/mm\^3

Hepatic

* AST and ALT \< 2 times upper limit of normal
* Bilirubin \< 2.0 mg/dL

Renal

* Creatinine \< 1.9 mg/dL

Cardiovascular

* No unstable\* cardiac disease despite medication (e.g., diuretics or digitalis)
* No uncontrolled hypertension (i.e., systolic blood pressure ≥ 170 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) despite medication NOTE: \*Unstable defined as unable to walk across the room without chest pain or shortness of breath

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception for at least 2 months before and during study treatment
* Resident of a clinical center metropolitan area or obtaining regular health care in a clinical metropolitan area for at least 6 months out of the year
* Must be able to swallow pills
* No unexpected weight loss of 10% or more within the past 6 months
* No prior rheumatoid arthritis
* No poorly controlled diabetes mellitus despite medication, defined as:

  * Blood sugar level ≥ 200 mg/dL on more than half of the readings taken within the past month
* No invasive malignancy within the past 5 years that required medical excision, radiotherapy, or chemotherapy except basal cell or squamous cell carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent drugs that regulate the immune system

Chemotherapy

* No concurrent chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No concurrent radiotherapy

Surgery

* See Disease Characteristics

Other

* Prior enrollment in another adenoma prevention study allowed
* Concurrent routine aspirin (≤ 81 mg/day) allowed
* No regular use of non-steroidal anti-inflammatory drugs (NSAIDs)
* No concurrent enrollment in another research study using pharmacological cancer drugs, a cyclo-oxygenase-2 inhibitor, or selenium
* No other concurrent selenium unless dosage is ≤ 50 µg/day
C: Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

* Diabetes mellitus
* Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
* Smoker at time of qualifying stroke
* Obesity (BMI\>30; BMI=weight (kg)/\[height (m)\]2)
* Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
* End-organ-damage (retinopathy, LVH, or microalbuminuria)
* Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.
D: Inclusion Criteria:

* Aged 70 years or older.
* Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
* Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.
* Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.
* Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
* Ability and intention to participate in regular study visits, in the opinion of the study physician.
* Provision of informed consent.

Exclusion Criteria:

* History of peptic ulcer disease with bleeding or obstruction.
* Clinically significant liver or kidney disease.
* History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.
* Use of anti-coagulant medication.
* Cognitive impairment or dementia.
* Current alcohol abuse or dependence

Answer: B