Psoriasis — Aggressive Weight Loss Program in Chronic Plaque Psoriasis
Citation(s)
Castaldo G, Galdo G, Rotondi Aufiero F, Cereda E Very low-calorie ketogenic diet may allow restoring response to systemic therapy in relapsing plaque psoriasis. Obes Res Clin Pract. 2016 May-Jun;10(3):348-52. doi: 10.1016/j.orcp.2015.10.008. Epub 2015 Nov 11.
Castaldo G, Monaco L, Castaldo L, Galdo G, Cereda E An observational study of sequential protein-sparing, very low-calorie ketogenic diet (Oloproteic diet) and hypocaloric Mediterranean-like diet for the treatment of obesity. Int J Food Sci Nutr. 2016 Sep;67(6):696-706. doi: 10.1080/09637486.2016.1186157. Epub 2016 May 18.
Castaldo G, Palmieri V, Galdo G, Castaldo L, Molettieri P, Vitale A, Monaco L Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors. Obes Res Clin Pract. 2016 Mar-Apr;10(2):169-77. doi: 10.1016/j.orcp.2015.05.001. Epub 2015 Jun 1.
A Single-arm Trial to Evaluate the Efficacy of an Aggressive Weight Loss Program With a Ketogenic Induction Phase for the Treatment of Chronic Plaque Psoriasis
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.
