Please select the eligibility criteria that correspond to the clinical trial below.
Title: Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial
Brief Summary: Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place - this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.


Options:
A: Inclusion Criteria:

1. Age \> 18 years
2. Able to provide informed consent
3. Isolated CABG, non-emergent, on- or off-pump (cardiopulmonary bypass)
4. Primary or re-do CABG (if re-do, all previous grafts must be occluded)
5. Left ventricular ejection fraction \>20%
6. Require at least one SVG as part of revascularization strategy
7. Creatinine clearance of at least 30ml/min or higher

Exclusion Criteria:

1. Unable to use greater SV due to previous vein stripping or poor quality on mandatory preoperative Duplex study and vein mapping
2. Contraindication to receiving follow-up 64-slice cardiac CT angiography (allergy to contrast dye, renal failure with a creatinine \>180 µmol/L, uncontrolled atrial fibrillation precluding proper gating of study)
3. Pregnant women, or women of child-bearing age
4. Allergy to fish oil/fish products, and non-medicinal ingredients of the study product (corn oil,soybean oil,gelatin,glycerol, or carob colouring)
5. Already taking fish oil supplements regularly (daily use in past 30 days)
6. Congenital or acquired coagulation disorders
7. Patients considered to be of excessive risk of wound infection according to the clinical judgement of the site surgical investigator.
B: Inclusion Criteria:

* Diagnosis of definite NASH
* Patients with diabetes taking stable doses of anti-diabetic agents are eligible
* No significant concomitant medical illness

Exclusion Criteria:

* Diagnosis of cirrhosis.
* Serum ALT \> 300 U/L
* Use of drugs associated with steatohepatitis
* Use of the following anit-NASH agents:

  1. Vitamin E \> 60 IU per day
  2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements \> 200 mg per day
  3. Thiazolidinediones (e.g. pioglitazone)
* Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
* Other liver disease
C: * This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States
* Participants who live in selected metropolitan areas of the U.S. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.
D: Key Inclusion Criteria:

* symptomatic active Crohn's disease (requiring a 16-week course of induction steroid therapy at a starting dose of prednisone 40 mg or budesonide 9 mg daily)
* respond to induction therapy (CDAI\<150) following 8 weeks of steroid tapering regimen to prednisone 20 mg or budesonide 6 mg daily
* Crohn's disease of at least 3 months duration
* 16 years of age or older

Key Exclusion Criteria:

* intolerance of omega-3 free fatty acid (FFA)
* intolerance of both prednisone and budesonide
* ongoing therapy for Crohn's disease with: 5-ASA compounds, immune modifiers, systemic antibiotics, tube feeding
* received in the past 3 months: systemic steroid therapy (other than study prednisone or budesonide induction therapy), azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products, preparations containing omega-3 fatty acids
* received in the past 6 months: biologicals e.g. enbrel, infliximab, monoclonal antibody, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products
* chronic narcotic analgesics for pain control
* short bowel syndrome, ostomy or need for bowel surgery for Crohn's disease, bowel obstruction or resection in the past 3 months
* malignancy, clinically significant impairment or conditions which could interfere with the evaluation of the trial medication
* clinically relevant hematology, liver and renal function laboratory tests
* known allergy to fish or fish products

Answer: A