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Clinical Trials
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] |
Human Subject Research
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial Participant Receives Injection (34033294061)
Clinical may refer to: Healthcare * Of or about a clinic, a healthcare facility * Of or about the practice of medicine Other uses * Clinical (film), ''Clinical'' (film), a 2017 American horror thriller See also * * * Clinical chemistry, the analysis of bodily fluids for diagnostic and therapeutic purposes * Clinical death, the cessation of blood circulation and breathing * Clinical formulation, a theoretically-based explanation of information obtained from clinical assessment * Clinical governance, a systematic approach to maintaining and improving the quality of patient care * Clinical linguistics, linguistics applied to speech-language pathology * Clinical psychology, the understanding, preventing, and relieving psychologically-based distress or dysfunction * Clinical research, to determine the safety and effectiveness of medications etc. * Clinical significance, the practical importance of a treatment effect * Clinical trial, experiments or observations done in clinical re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Authority
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity. Examples of responsibilities include strengthening safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India. Legislative basis Regulatory agencies deal in the areas of administrative law, regulatory law, secondary legislation, and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Psychological Therapies
Psychotherapy (also psychological therapy, talk therapy, or talking therapy) is the use of psychological methods, particularly when based on regular personal interaction, to help a person change behavior, increase happiness, and overcome problems. Psychotherapy aims to improve an individual's well-being and mental health, to resolve or mitigate troublesome behaviors, beliefs, compulsions, thoughts, or emotions, and to improve relationships and social skills. Numerous types of psychotherapy have been designed either for individual adults, families, or children and adolescents. Some types of psychotherapy are considered evidence-based for treating diagnosed mental disorders; other types have been criticized as pseudoscience. There are hundreds of psychotherapy techniques, some being minor variations; others are based on very different conceptions of psychology. Most approaches involve one-to-one sessions, between the client and therapist, but some are conducted with groups, i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Diagnosis
Medical diagnosis (abbreviated Dx, Dx, or Ds) is the process of determining which disease or condition explains a person's symptoms and signs. It is most often referred to as a diagnosis with the medical context being implicit. The information required for a diagnosis is typically collected from a history and physical examination of the person seeking medical care. Often, one or more diagnostic procedures, such as medical tests, are also done during the process. Sometimes the posthumous diagnosis is considered a kind of medical diagnosis. Diagnosis is often challenging because many signs and symptoms are nonspecific. For example, redness of the skin ( erythema), by itself, is a sign of many disorders and thus does not tell the healthcare professional what is wrong. Thus differential diagnosis, in which several possible explanations are compared and contrasted, must be performed. This involves the correlation of various pieces of information followed by the recognition and d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biologic Medical Product
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biopharmaceuticals can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. The term biologics is often used more res ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Scientific Method
The scientific method is an Empirical evidence, empirical method for acquiring knowledge that has been referred to while doing science since at least the 17th century. Historically, it was developed through the centuries from the ancient and medieval world. The scientific method involves careful observation coupled with rigorous skepticism, because Philosophy of science#Observation inseparable from theory, cognitive assumptions can distort the interpretation of the Perception#Process and terminology, observation. Scientific inquiry includes creating a testable hypothesis through inductive reasoning, testing it through experiments and statistical analysis, and adjusting or discarding the hypothesis based on the results. Although procedures vary across Branches of science, fields, the underlying #Process, process is often similar. In more detail: the scientific method involves making conjectures (hypothetical explanations), predicting the logical consequences of hypothesis, then ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hypothesis
A hypothesis (: hypotheses) is a proposed explanation for a phenomenon. A scientific hypothesis must be based on observations and make a testable and reproducible prediction about reality, in a process beginning with an educated guess or thought. If a hypothesis is repeatedly independently demonstrated by experiment to be true, it becomes a scientific theory. In colloquial usage, the words "hypothesis" and "theory" are often used interchangeably, but this is incorrect in the context of science. A working hypothesis is a provisionally-accepted hypothesis used for the purpose of pursuing further progress in research. Working hypotheses are frequently discarded, and often proposed with knowledge (and warning) that they are incomplete and thus false, with the intent of moving research in at least somewhat the right direction, especially when scientists are stuck on an issue and brainstorming ideas. A different meaning of the term ''hypothesis'' is used in formal l ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial Protocol
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., ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Placebo
A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials to test the efficacy of medical treatments. In a placebo-controlled trial, any change in the control group is known as the ''placebo response'', and the difference between this and the result of no treatment is the ''placebo effect''. Placebos in clinical trials should ideally be indistinguishable from so-called verum treatments under investigation, except for the latter's particular hypothesized medicinal effect. This is to shield test participants (with their consent) from knowing who is getting the placebo and who is getting the treatment under test, as patients' and clinicians' expectations of efficacy can influence results. The idea of a placebo effect was discussed in 18th century psychology, but became more prominent in the 20th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Statistical Hypothesis Testing
A statistical hypothesis test is a method of statistical inference used to decide whether the data provide sufficient evidence to reject a particular hypothesis. A statistical hypothesis test typically involves a calculation of a test statistic. Then a decision is made, either by comparing the test statistic to a Critical value (statistics), critical value or equivalently by evaluating a p-value, ''p''-value computed from the test statistic. Roughly 100 list of statistical tests, specialized statistical tests are in use and noteworthy. History While hypothesis testing was popularized early in the 20th century, early forms were used in the 1700s. The first use is credited to John Arbuthnot (1710), followed by Pierre-Simon Laplace (1770s), in analyzing the human sex ratio at birth; see . Choice of null hypothesis Paul Meehl has argued that the epistemological importance of the choice of null hypothesis has gone largely unacknowledged. When the null hypothesis is predicted by the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vital Signs
Vital signs (also known as vitals) are a group of the four to six most crucial medical signs that indicate the status of the body's vital (life-sustaining) functions. These measurements are taken to help assess the general physical health of a person, give clues to possible diseases, and show progress toward recovery. The normal ranges for a person's vital signs vary with age, weight, sex, and overall health. There are four primary vital signs: body temperature, blood pressure, pulse (heart rate), and breathing rate ( respiratory rate), often notated as BT, BP, HR, and RR. However, depending on the clinical setting, the vital signs may include other measurements called the "fifth vital sign" or "sixth vital sign." Early warning scores have been proposed that combine the individual values of vital signs into a single score. This was done in recognition that deteriorating vital signs often precede cardiac arrest and/or admission to the intensive care unit. Used appropriately ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
