Borg J, Melander O, Johansson L, Uvnäs-Moberg K, Rehfeld JF, Ohlsson B Gastroparesis is associated with oxytocin deficiency, oesophageal dysmotility with hyperCCKemia, and autonomic neuropathy with hypergastrinemia. BMC Gastroenterol. 2009 Feb 25;9:17. doi: 10.1186/1471-230X-9-17.
Burton-Freeman B, Davis PA, Schneeman BO Plasma cholecystokinin is associated with subjective measures of satiety in women. Am J Clin Nutr. 2002 Sep;76(3):659-67.
Dall TM, Fulgoni VL 3rd, Zhang Y, Reimers KJ, Packard PT, Astwood JD Potential health benefits and medical cost savings from calorie, sodium, and saturated fat reductions in the American diet. Am J Health Promot. 2009 Jul-Aug;23(6):412-22. doi: 10.4278/ajhp.080930-QUAN-226.
McCann UD, Slate SO, Geraci M, Roscow-Terrill D, Uhde TW A comparison of the effects of intravenous pentagastrin on patients with social phobia, panic disorder and healthy controls. Neuropsychopharmacology. 1997 Mar;16(3):229-37.
Monstein HJ, Grahn N, Truedsson M, Ohlsson B Oxytocin and oxytocin-receptor mRNA expression in the human gastrointestinal tract: a polymerase chain reaction study. Regul Pept. 2004 Jun 15;119(1-2):39-44.
Moran TH, Dailey MJ Minireview: Gut peptides: targets for antiobesity drug development? Endocrinology. 2009 Jun;150(6):2526-30. doi: 10.1210/en.2009-0003. Epub 2009 Apr 16. Review.
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.
