Assimakopoulos SF, Scopa CD, Vagianos CE Pathophysiology of increased intestinal permeability in obstructive jaundice. World J Gastroenterol. 2007 Dec 28;13(48):6458-64. Review.
Betjes MG, Bajema I The pathology of jaundice-related renal insufficiency: cholemic nephrosis revisited. J Nephrol. 2006 Mar-Apr;19(2):229-33.
Hritz I, Hegyi P Early Achievable Severity (EASY) index for simple and accurate expedite risk stratification in acute pancreatitis. J Gastrointestin Liver Dis. 2015 Jun;24(2):177-82. doi: 10.15403/jgld.2014.1121.242.easy.
N Shachiri DK, D Tonev, M Shishenkov Hemostasiologic Changes during Hepatobiliary Surgery in Patients with Obstructive Jaundice: Pathophysiology and Clinical Considerations. The Internet Journal of Anesthesiology. 2010;28(1).
Sun C, Yan G, Li Z, Tzeng CM A meta-analysis of the effect of preoperative biliary stenting on patients with obstructive jaundice. Medicine (Baltimore). 2014 Nov;93(26):e189. doi: 10.1097/MD.0000000000000189.
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.