Clinical trial protocol

Rufinamide (Banzel) was designated as an orphan drug for use in the treatment of seizures that are caused by Lennox—Gastaut syndrome in patients older than four in 2004 by the FDA (Food and Drug Adminsitration).¬¬¬¬¬1 Lennox—Gastaut syndrome (LGS) is a epileptic disease, commonly found in children, that is characterized a high rate of injury from seizures as well as a wide range of treatment-resistant seizures. In the past treatments were inadequate, leaving patients without much, but after the…

Both my partner, Emily Rood and I are intrigued by the placebo effect in medicine, thus choosing to answer the following question as our topic: Is it permissible to prescribe placebos without the patient knowing? A placebo is a harmless medicine given to patients by their physician to mentally induce healing for the patient. The placebo is purely physiological because the patient believe that he/she is receiving a medicine to cure a discomfort, but the actual medicine doesn’t alleviate the…

of CD-4 study in the Chapter 15 The Guillain-Barre Syndrome. As a pharmacy student with interest in clinical research, I understand the importance to get the consent of the patients including not only the possible advantages but also the uncertainty of the risks. In this story, an AIDS patient with failure of three courses of therapy eagerly wanted to be enrolled in the CD-4 phase 1 clinical trial because of this patient’s strong belief that he would be healthy and cured after the novel…

using an oscillometric device instead. Clinical practice guidelines can help standardize treatment plans and assist healthcare professionals when making educated clinical choices (Jun, Kovner, & Stimpfel, 2016). This essay will discuss guidelines, updating practices, nurses being educated on guidelines and forming a question surround guidelines Clinical guidelines must have the best evidence available, helping the health professional but not replacing clinical judgment, skills or knowledge…

It is combined with clinical judgments and patient’ preferences to obtain an outcome which is the best quality cost -effectiveness of patient care. It is not only important for nurses to know the right thing to do but also to know why it is the right thing to do. For example some nurses know that a particular method must be implemented but ignore the scientific reasoning behind it, which means they don’t know what research support the method. Some nurses implement evidence based practice method…

One might assume that counterfeit pharmaceuticals wouldn’t pose as such a large problem due to stringent government programs such as the FDA. But, unfortunately, these drugs sneak under the FDA radar and aren’t regulated in the slightest. The FDA is the Food and Drug Administration and it is responsible for monitoring the safety, efficacy, quality and security of a variety of products distributed across America and other US territories. Their aim as an organization is to inform and educate…

Which Drug Would You Choose? I did not know what Alzheimer’s disease was until I spent extended time with my great aunt Vickie. I was visiting her during a family vacation and over a few hours she kept repeating herself to me, asking the same question over and over. I asked my mother why Aunt Vickie was unable to remember my name and who I was. My mother explained to me that, at 89, the elderly start to lose their memory. She explained it as, “when people get older they start to lose their…

adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design gives greater benefit compare to the traditional drug trial design for the success of the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in the clinical trials. Adaptive trial design allows researchers modification in the clinical trial and statistical procedure of the clinical trial after…

Critically evaluate health and social care services There is a growing demand for healthcare services and this is because there is an inevitable need for care (Stevens and Gabbay, 1991). These services are delivered as a result of a combination of inputs, including resources, organisation, funding, management and knowledge (Mills and Ransom, 2001). Whilst it being simple in principle, it is much more difficult in practice as all these factors put together make very complex healthcare systems,…

patient. According to the article Lifelong Learning: Fostering a Culture of Curiosity, “in order to assure patients optimal care, nurses must be well versed in the most accurate and current information in clinical practice… and they need an expansion of knowledge related to the most current clinical treatments, procedures, and practices”. New technology has also challenged many nurses from the 20th century, as well as new updated skills that were not done before are now being implemented. In…