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By using our site, you agree to our collection of information through the use of cookies. To learn more, view our Privacy Policy. To browse Academia. This study investigates hippocampal remodelling following neurotoxic effects of MDMA 3,4-methylenedioxymethamphetamine through a single case analysis. Emphasis is placed on changes within brain structures and potential recovery mechanisms after exposure to MDMA. The findings suggest significant neuroplastic changes in the hippocampus post-MDMA use, highlighting implications for understanding long-term effects of recreational substances on brain health.
Various neurobiological factors contributing to observed structural modifications are discussed, along with considerations for future research directions. A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are fastest and safest way to find treatment that work in people and way to improve health.
Investigational trials determine whether experimental treatment or new ways of using known therapies are safe and effective under controlled environment. Observational trials address health issues in large groups of people or population in natural settings. Clinical trials aim to measure therapeutic effectiveness and constitute an important and highly specialized form of biological assay.
In phase I pharmacokinetics, safety, gross effects are studied on human volunteers, by clinical pharmacologists. If the drug passes the test, it enters phase II testings, where pharmacokinetics, safety, therapeutic efficiency are studied on selected patients by clinical pharmacologist, if passes hundreds of selected patients are now studied, primarily for safety and therapeutic effectiveness by clinical investigators in phase III. If this is passed the drug is now approved and marketed.
Even after marketing, physicians from various hospitals and clinics send their opinion about the drug, regarding ADR, efficacy in phase IV. Introduction of clinical trials in clinical practice has revolutionized the medical judgment and heralded the modern era of evidence-based medicine. The history of medical trials as an evolution of scientific thought, traces back to simple observational studies and remedy attempts created from the beginning by the authorities and fashion of the time.