McKay TB, Qu J, Liang F, Mueller A, Wiener-Kronish J, Xie Z, Akeju O Tau as a serum biomarker of delirium after major cardiac surgery: a single centre case-control study. Br J Anaesth. 2022 Jul;129(1):e13-e16. doi: 10.1016/j.bja.2022.04.002. Epub 2022 Apr 22. No abstract available.
Wang W, Ma Y, Liu Y, Wang P, Liu Y Effects of Dexmedetomidine Anesthesia on Early Postoperative Cognitive Dysfunction in Elderly Patients. ACS Chem Neurosci. 2022 Aug 3;13(15):2309-2314. doi: 10.1021/acschemneuro.2c00173. Epub 2022 Jul 21.
Effect of Dexmedetomidine on Serum Tau-217 Protein as a Biomarker for Post-operative Cognitive Dysfunction in Elderly Patients.
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.
