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Challenge–dechallenge–rechallenge
Challenge–dechallenge–rechallenge (CDR) is a medical testing protocol in which a medicine or drug is administered, withdrawn, then re-administered, while being monitored for adverse effects at each stage. The protocol is used when statistical testing is inappropriate due to an idiosyncratic reaction by a specific individual, or a lack of sufficient test subjects and unit of analysis is the individual. During the dechallenge (withdrawal) phase, the medication is allowed to wash out of the system in order to determine what effect the medication is having on an individual. Use in drug testing CDR is one means of establishing the validity and benefits of medication in treating specific conditions as well as any adverse drug reactions. The Food and Drug Administration of the United States lists positive dechallenge reactions (an adverse event which disappears on withdrawal of the medication) as well as negative (an adverse event which continues after withdrawal), as well as pos ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Protocol (natural Sciences)
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias. Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g., blo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'experime ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Single-subject Design
In design of experiments, single-subject curriculum or single-case research design is a research design most often used in applied fields of psychology, education, and human behaviour in which the subject serves as his/her own control, rather than using another individual/group. Researchers use single-subject design because these designs are sensitive to individual organism differences vs group designs which are sensitive to averages of groups. The logic behind single subject designs is 1) Prediction, 2) Verification, and 3) Replication. The baseline data predicts behaviour by affirming the consequent. Verification refers to demonstrating that the baseline responding would have continued had no intervention been implemented. Replication occurs when a previously observed behaviour changed is reproduced.Cooper, J. O., Heron, T. E., & Heward, W. L. (2007). Applied behavior analysis (2nd ed.). Columbus, OH: Merrill Prentice Hall. There can be large numbers of subjects in a research study ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Self-experimentation In Medicine
Self-experimentation refers to scientific experimentation in which the experimenter conducts the experiment on themself. Often this means that the designer, operator, subject, analyst, and user or reporter of the experiment are all the same. Self-experimentation has a long and well-documented history in medicine which continues to the present. Some of these experiments have been very valuable and shed new and often unexpected insights into different areas of medicine. There are many motivations for self-experiment. These include the wish to get results quickly and avoid the need for a formal organisational structure, to take the ethical stance of taking the same risk as volunteers, or just a desire to do good for humanity. Other ethical issues include whether a researcher should self-experiment because another volunteer would not get the same benefit as the researcher will get, and the question of whether informed consent of a volunteer can truly be given by those outside a rese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Akathisia
Akathisia is a movement disorder characterized by a subjective feeling of inner restlessness accompanied by mental distress and an inability to sit still. Usually, the legs are most prominently affected. Those affected may fidget, rock back and forth, or pace, while some may just have an uneasy feeling in their body. The most severe cases may result in aggression, violence, and/or suicidal thoughts. Akathisia is also associated with threatening behaviour and physical aggression that is greatest in patients with mild akathisia, and diminishing with increasing severity of akathisia. Antipsychotic medication, particularly the first generation antipsychotics, are a leading cause. Other agents commonly responsible for this side-effect may also include selective serotonin reuptake inhibitors, metoclopramide, and reserpine, though any medication listing agitation as a side effect may trigger it. It may also occur upon stopping antipsychotics. The underlying mechanism is believed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Philadelphia
Philadelphia, often called Philly, is the largest city in the Commonwealth of Pennsylvania, the sixth-largest city in the U.S., the second-largest city in both the Northeast megalopolis and Mid-Atlantic regions after New York City. Since 1854, the city has been coextensive with Philadelphia County, the most populous county in Pennsylvania and the urban core of the Delaware Valley, the nation's seventh-largest and one of world's largest metropolitan regions, with 6.245 million residents . The city's population at the 2020 census was 1,603,797, and over 56 million people live within of Philadelphia. Philadelphia was founded in 1682 by William Penn, an English Quaker. The city served as capital of the Pennsylvania Colony during the British colonial era and went on to play a historic and vital role as the central meeting place for the nation's founding fathers whose plans and actions in Philadelphia ultimately inspired the American Revolution and the nation's inde ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Eli Lilly And Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War. As of 2022, Lilly is known for its clinical depression drugs Prozac (fluoxetine) (1986) and Cymbalta ( duloxetine) (2004) and its antipsychotic medication Zyprexa ( olanzapine) (1996), although its primary revenue drivers are the diabetes drugs Humalog ( insulin lispro) (1996) and Trulicity ( dulaglutide) (2014). Lilly's achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk, and insulin. It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin ( insulin medication), Humalog ( insulin lispro), and the first approved biosimilar insulin product in the US ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Effect (medicine)
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a " side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as " iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Adverse effects can also be caused by placebo treatments (in which case the adverse effects are referred to as nocebo effects). Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse drug event (ADE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not associated with the administration of the drug. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications. Classification ADRs may be classified by e.g. cause and severity. Cause *Type A: Augmented pharmacologic effects - dose dependent and predictable :Type A reactions, which constitute approximatel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Suicidal Ideation
Suicidal ideation, or suicidal thoughts, means having thoughts, ideas, or ruminations about the possibility of ending one's own life.World Health Organization, ''ICD-11 for Mortality and Morbidity Statistics'', ver. 09/2020MB26.A Suicidal ideation/ref> It is not a diagnosis but is a symptom of some mental disorders and can also occur in response to adverse events without the presence of a mental disorder.Barry, Lisa C. Passive Suicidal Ideation in Older Adults: Implications for Suicide Prevention, ''American Journal of Geriatric Psychiatry'' 27, no. 12 (December 2019): 1411 ("... growing evidence points toward a subgroup of individuals who endorse passive SI uicidal ideationin later life outside the context of clinical depression.") On suicide risk scales, the range of suicidal ideation varies from fleeting thoughts to detailed planning. Passive suicidal ideation is thinking about not wanting to live or imagining being dead. Active suicidal ideation involves preparation to comm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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