| clinical studies | <pharmacology> Human studies that are designed to measure the safety, efficacy, and appropriate dosage of a new drug or biological. Clinical studies routinely involve the use of a placebo group that is given an inactive substance that looks like the test product. (14 Nov 1997) |
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| clinical syndrome | <syndrome> A clinical syndrome represents a typical constellation of physical (and laboratory) findings that may be seen as part of a primary disease process. A good example is shock, a clinical syndrome seen with many primary disease processes. (13 Nov 1997) |
| clinical thermometer | A small, self-registering thermometer, consisting of a simple scaled glass tube containing mercury, used for taking the temperature of the body. (05 Mar 2000) |
| clinical trial | <pharmacology> Research study conducted with patients, usually to evaluate a new treatment or drug. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease. (12 May 1997) |
| clinical trial, phase I | A pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on a small number of healthy persons and conducted over the period of about a year in either the united states or a foreign country. (12 Dec 1998) |
| clinical trial, phase II | A pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the united states or a foreign country. (12 Dec 1998) |
| clinical trial, phase III | A pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the united states or a foreign country. (12 Dec 1998) |
| clinical trial, phase IV | Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale after clinical trials, phases I, II, and III. These studies, conducted in the united states or a foreign country, often garner additional data about the safety and efficacy of a product. (12 Dec 1998) |
| clinical trials | Medical research studies conducted with volunteers. Each study is designed to answer scientific questions and to find better ways to prevent, detect, or treat cancer. (12 Dec 1998) |
| clinical trials, phase I | Studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the u.s. And in other countries. (12 Dec 1998) |
| clinical trials, phase II | Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the u.s. And in other countries. (12 Dec 1998) |
| clinical trials, phase III | Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the u.s. And in other countries. (12 Dec 1998) |
| clinical trials, phase IV | Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the u.s. And in other countries. (12 Dec 1998) |
| controlled clinical trial | A clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterised as a randomised controlled trial. However, trials employing treatment allocation methods such as coin flips, odd-even numbers, patient social security numbers, days of the week, medical record numbers, or other such pseudo- or quasi-random processes are simply designated as controlled clinical trials. (12 Dec 1998) |
| controlled clinical trials | Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterised as randomised controlled trials. However, trials employing treatment allocation methods such as coin flips, odd-even numbers, patient social security numbers, days of the week, medical record numbers, or other such pseudo- or quasi-random processes, are simply designated as controlled clinical trials. (12 Dec 1998) |