Bozzetti F, Braga M, Gianotti L, Gavazzi C, Mariani L Postoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial. Lancet. 2001 Nov 3;358(9292):1487-92.
Davies SJ, Wilson RJ Preoperative optimization of the high-risk surgical patient. Br J Anaesth. 2004 Jul;93(1):121-8. Epub 2004 Apr 30. Review.
De Backer D, Creteur J, Vincent JL Perioperative optimization and right heart catheterization: what technique in which patient? Crit Care. 2003 Jun;7(3):201-2. Epub 2003 Mar 14.
Flancbaum L, Ziegler DW, Choban PS Preoperative intensive care unit admission and hemodynamic monitoring in patients scheduled for major elective noncardiac surgery: a retrospective review of 95 patients. J Cardiothorac Vasc Anesth. 1998 Feb;12(1):3-9.
Garner JS The CDC Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1993 Jun;21(3):160-2.
Gessler P, Pfenninger J, Pfammatter JP, Carrel T, Dahinden C Inflammatory response of neutrophil granulocytes and monocytes after cardiopulmonary bypass in pediatric cardiac surgery. Intensive Care Med. 2002 Dec;28(12):1786-91. Epub 2002 Oct 17.
Higgins TL, Estafanous FG, Loop FD, Beck GJ, Blum JM, Paranandi L Stratification of morbidity and mortality outcome by preoperative risk factors in coronary artery bypass patients. A clinical severity score. JAMA. 1992 May 6;267(17):2344-8. Erratum in: JAMA 1992 Oct 14;268(14):1860.
Jones SM, Thurman RG L-arginine minimizes reperfusion injury in a low-flow, reflow model of liver perfusion. Hepatology. 1996 Jul;24(1):163-8.
Kaplan LJ, McPartland K, Santora TA, Trooskin SZ Start with a subjective assessment of skin temperature to identify hypoperfusion in intensive care unit patients. J Trauma. 2001 Apr;50(4):620-7; discussion 627-8.
Kress HG, Scheidewig C, Schmidt H, Silber R Reduced incidence of postoperative infection after intravenous administration of an immunoglobulin A- and immunoglobulin M-enriched preparation in anergic patients undergoing cardiac surgery. Crit Care Med. 1999 Jul;27(7):1281-7.
Kulkarni AD, Rudolph FB, Van Buren CT The role of dietary sources of nucleotides in immune function: a review. J Nutr. 1994 Aug;124(8 Suppl):1442S-1446S. Review.
The Effect of Pre- and Postoperative Supplemental Enteral Nutrition in High-Risk Patients Undergoing Elective Cardiac Surgery. A Prospective Double Blind Study.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.