Please select the eligibility criteria that correspond to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: Inclusion Criteria:

1. Patients should be admitted to a coronary care unit for acute coronary syndrome (ACS), and should be enrolled within 4 weeks after the primary ACS.
2. Participants should be 18 years or older.
3. No sign of depression on Major Depression Inventory (MDI) at the point of enrolment.
4. Participants must sign an informed consent form
5. Females not in menopause (defined as no menstruation during the last 12 months) should have a negative pregnancy test.

Exclusion Criteria:

1. Known allergic reaction to melatonin.
2. Ongoing or previous pharmacological treated depression or bipolar disorder.
3. No dementia as determined by mini mental state examination score (MMSE) \< 24
4. At the point of inclusion no participation in another pharmacological intervention trial is allowed.
5. No diagnose of Rotor or Dubin-Johnson syndrome, epilepsy, sleep apnoea syndrome, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or multiple sclerosis is allowed.
6. Severe liver disease defined as transaminases above X 3 normal levels, and severe kidney disease defined as eGRF under 40 ml/min.
7. Ongoing hypnotic treatment.
8. Known sleep disorder (e.g. insomnia, restless legs etc.)
9. Work involving nightshifts.
10. Daily alcohol consumption above 5 units of alcohol (1 unit = 12 g alcohol)
11. Predictable poor compliance ( e.g. not speaking fluent Danish)
12. Pregnant or breastfeeding.
13. Severe, life-threatening medical condition, that implies that the patient cannot participate in a the study course. (e.g. cancer, stroke, )
14. Indication for coronary artery bypass graft (CABG).

    For the MEFACS subtrial - (single center)
15. Conditions that preclude/make impossible the measurement of reliable RHI (e.g. patient with only one arm, known side-difference in brachial arterial blood pressure and other factors).
B: Inclusion Criteria:

* Age at least 65 years old
* Bilateral AMD
* Subthreshold depressive symptoms
* At least 1 vision goal that is important yet difficult to carry out

Exclusion Criteria:

* Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which surgery within 6 months is likely will be exclusionary conditions
* Current diagnosis of depression
* Cognitive impairment
* Life-threatening illness or any other health conditions that interferes with study activities.
* Patients who have received low vision rehabilitation or home-based OT in the preceding 12 months will be excluded.
C: Inclusion Criteria:

* Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA
* Agree to take study medication
* Be geographically accessible for follow-up
* Provide written informed consent

Exclusion Criteria:

* Taking folic acid or B6 on medical advice
* Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)
* Taking Methotrexate for any reason
* Pregnancy or women of child-bearing potential who are at risk of pregnancy
* Limited life expectancy
D: Inclusion Criteria:

* ACS
* Randomization within 8 weeks form index hospitalization for ACS
* Age \> 18 years
* Not pregnant
* Signed informed consent

Exclusion Criteria:

* Current depression
* Use of antidepressants \< 4 weeks
* Previous intolerance to SSRI
* Severe medical conditions
* Severe heart failure
* Alcohol or substance abuse
* Psychosis or dementia
* Current participation in other intervention trials
* Pregnancy and lactation
* Linguistic difficulties

Answer: C