Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about 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.
A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.
That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Statistical models of the production, distribution, and consumption of goods and services, as well as of financial considerations. For the application of statistics to the testing and quantifying of economic theories MODELS, ECONOMETRIC is available.
The amount that a health care institution or organization pays for its drugs. It is one component of the final price that is charged to the consumer (FEES, PHARMACEUTICAL or PRESCRIPTION FEES).
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.
Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.
The term "United States" in a medical context often refers to the country where a patient or study participant resides, and is not a medical term per se, but relevant for epidemiological studies, healthcare policies, and understanding differences in disease prevalence, treatment patterns, and health outcomes across various geographic locations.
Therapy with two or more separate preparations given for a combined effect.
The composition of a committee; the state or status of being a member of a committee.
Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)
Elements of limited time intervals, contributing to particular results or situations.
Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
Substances that inhibit or prevent the proliferation of NEOPLASMS.
Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.
An aspect of personal behavior or lifestyle, environmental exposure, or inborn or inherited characteristic, which, on the basis of epidemiologic evidence, is known to be associated with a health-related condition considered important to prevent.
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.
Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children.
A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).
Works about 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.
An advisory group composed primarily of staff physicians and the pharmacist which serves as the communication link between the medical staff and the pharmacy department.
Institutional committees established to protect the welfare of animals used in research and education. The 1971 NIH Guide for the Care and Use of Laboratory Animals introduced the policy that institutions using warm-blooded animals in projects supported by NIH grants either be accredited by a recognized professional laboratory animal accrediting body or establish its own committee to evaluate animal care; the Public Health Service adopted a policy in 1979 requiring such committees; and the 1985 amendments to the Animal Welfare Act mandate review and approval of federally funded research with animals by a formally designated Institutional Animal Care and Use Committee (IACUC).
Works about 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.
An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)
Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.
Works about 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 characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.
Individual's rights to obtain and use information collected or generated by others.
Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.
Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Societies whose membership is limited to physicians.
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
The circulation or wide dispersal of information.
Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
The actual costs of providing services related to the delivery of health care, including the costs of procedures, therapies, and medications. It is differentiated from HEALTH EXPENDITURES, which refers to the amount of money paid for the services, and from fees, which refers to the amount charged, regardless of cost.
Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.
The use of humans as investigational subjects.
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.
Great Britain is not a medical term, but a geographical name for the largest island in the British Isles, which comprises England, Scotland, and Wales, forming the major part of the United Kingdom.
I'm sorry for any confusion, but 'Europe' is a geographical continent and not a medical term; therefore, it doesn't have a medical definition.
Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
Tumors or cancer of the human BREAST.
The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.
A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.
Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.
Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.
The relationship between the dose of an administered drug and the response of the organism to the drug.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
The return of a sign, symptom, or disease after a remission.
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Earlier than planned termination of clinical trials.
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.
Drugs that are used to treat RHEUMATOID ARTHRITIS.
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.
Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.
Disease having a short and relatively severe course.
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95)
Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system.
Services provided by an individual ethicist (ETHICISTS) or an ethics team or committee (ETHICS COMMITTEES, CLINICAL) to address the ethical issues involved in a specific clinical case. The central purpose is to improve the process and outcomes of patients' care by helping to identify, analyze, and resolve ethical problems.
Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.
Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN.
Substances that reduce the growth or reproduction of BACTERIA.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Age as a constituent element or influence contributing to the production of a result. It may be applicable to the cause or the effect of a circumstance. It is used with human or animal concepts but should be differentiated from AGING, a physiological process, and TIME FACTORS which refers only to the passage of time.
Antibodies produced by a single clone of cells.
Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.
The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used.
Agents that prevent clotting.
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)
Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS.
The number of new cases of a given disease during a given period in a specified population. It also is used for the rate at which new events occur in a defined population. It is differentiated from PREVALENCE, which refers to all cases, new or old, in the population at a given time.
A subspecialty of internal medicine concerned with the study of neoplasms.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.
A stochastic process such that the conditional probability distribution for a state at any future instant, given the present state, is unaffected by any additional knowledge of the past history of the system.
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).
A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.
Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.
Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.
Schedule giving optimum times usually for primary and/or secondary immunization.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Financial support of research activities.
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.
The giving of drugs, chemicals, or other substances by mouth.
Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.
A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.
Voluntary cooperation of the patient in following a prescribed regimen.
Recommendations for directing health planning functions and policies. These may be mandated by PL93-641 and issued by the Department of Health and Human Services for use by state and local planning agencies.
"The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing.
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
The proportion of survivors in a group, e.g., of patients, studied and followed over a period, or the proportion of persons in a specified group alive at the beginning of a time interval who survive to the end of the interval. It is often studied using life table methods.
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
Administration of vaccines to stimulate the host's immune response. This includes any preparation intended for active immunological prophylaxis.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
The use of animals as investigational subjects.
Those individuals engaged in research.
The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
An operating division of the US Department of Health and Human Services. It is concerned with the overall planning, promoting, and administering of programs pertaining to health and medical research. Until 1995, it was an agency of the United States PUBLIC HEALTH SERVICE.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
Patient involvement in the decision-making process in matters pertaining to health.
Component of the NATIONAL INSTITUTES OF HEALTH. Through basic and clinical biomedical research and training, it conducts and supports research with the objective of cancer prevention, early stage identification and elimination. This Institute was established in 1937.
Products in capsule, tablet or liquid form that provide dietary ingredients, and that are intended to be taken by mouth to increase the intake of nutrients. Dietary supplements can include macronutrients, such as proteins, carbohydrates, and fats; and/or MICRONUTRIENTS, such as VITAMINS; MINERALS; and PHYTOCHEMICALS.
Exercise of governmental authority to control conduct.
Computer-based representation of physical systems and phenomena such as chemical processes.
Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)
A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.
The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
An infant during the first month after birth.
Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.
The teaching or training of patients concerning their own health needs.
Time period from 1901 through 2000 of the common era.
A nonparametric method of compiling LIFE TABLES or survival tables. It combines calculated probabilities of survival and estimates to allow for observations occurring beyond a measurement threshold, which are assumed to occur randomly. Time intervals are defined as ending each time an event occurs and are therefore unequal. (From Last, A Dictionary of Epidemiology, 1995)
The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial.
The guidelines and policy statements set forth by the editor(s) or editorial board of a publication.
The evaluation by experts of the quality and pertinence of research or research proposals of other experts in the same field. Peer review is used by editors in deciding which submissions warrant publication, by granting agencies to determine which proposals should be funded, and by academic institutions in tenure decisions.
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.
Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc.
The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.
Tumors or cancer of the LUNG.
General agreement or collective opinion; the judgment arrived at by most of those concerned.
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
A publication issued at stated, more or less regular, intervals.
Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa), antigenic proteins, synthetic constructs, or other bio-molecular derivatives, administered for the prevention, amelioration, or treatment of infectious and other diseases.
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.
Revealing of information, by oral or written communication.
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
A measure of the quality of health care by assessment of unsuccessful results of management and procedures used in combating disease, in individual cases or series.
Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.
Control which is exerted by the more stable organizations of society, such as established institutions and the law. They are ordinarily embodied in definite codes, usually written.
Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.
Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses).
A class of statistical methods applicable to a large set of probability distributions used to test for correlation, location, independence, etc. In most nonparametric statistical tests, the original scores or observations are replaced by another variable containing less information. An important class of nonparametric tests employs the ordinal properties of the data. Another class of tests uses information about whether an observation is above or below some fixed value such as the median, and a third class is based on the frequency of the occurrence of runs in the data. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1284; Corsini, Concise Encyclopedia of Psychology, 1987, p764-5)
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)
Conformity in fulfilling or following official, recognized, or institutional requirements, guidelines, recommendations, protocols, pathways, or other standards.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues.
The moral and ethical obligations or responsibilities of institutions.
Persons trained in philosophical or theological ethics who work in clinical, research, public policy, or other settings where they bring their expertise to bear on the analysis of ethical dilemmas in policies or cases. (Bioethics Thesaurus)
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)
Use of plants or herbs to treat diseases or to alleviate pain.
The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)
Differences of opinion or disagreements that may arise, for example, between health professionals and patients or their families, or against a political regime.
Treatments which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers.
The collective designation of three organizations with common membership: the European Economic Community (Common Market), the European Coal and Steel Community, and the European Atomic Energy Community (Euratom). It was known as the European Community until 1994. It is primarily an economic union with the principal objectives of free movement of goods, capital, and labor. Professional services, social, medical and paramedical, are subsumed under labor. The constituent countries are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. (The World Almanac and Book of Facts 1997, p842)
Studies determining the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. For drugs and devices, CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; and DRUG EVALUATION, PRECLINICAL are available.
Professional society representing the field of medicine.
Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.
Studies designed to assess the efficacy of programs. They may include the evaluation of cost-effectiveness, the extent to which objectives are met, or impact.
Clusters of topics that fall within the domain of BIOETHICS, the field of study concerned with value questions that arise in biomedicine and health care delivery.
Triazoles are a class of antifungal drugs that contain a triazole ring in their chemical structure and work by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, thereby disrupting the integrity and function of the membrane.
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices.
Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.
A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
The probability that an event will occur. It encompasses a variety of measures of the probability of a generally unfavorable outcome.
A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.
The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
Organizations representing specialized fields which are accepted as authoritative; may be non-governmental, university or an independent research organization, e.g., National Academy of Sciences, Brookings Institution, etc.
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
Identifies, for study and analysis, important issues and problems that relate to health and medicine. The Institute initiates and conducts studies of national policy and planning for health care and health-related education and research; it also responds to requests from the federal government and other agencies for studies and advice.

Unilateral transplantation of human primary fetal tissue in four patients with Huntington's disease: NEST-UK safety report ISRCTN no 36485475. (1/43)

OBJECTIVES: Huntington's disease (HD) is an inherited autosomal dominant condition in which there is a CAG repeat expansion in the huntingtin gene of 36 or more. Patients display progressive motor, cognitive, and behavioural deterioration associated with progressive cell loss and atrophy in the striatum. Currently there are no disease modifying treatments and current symptomatic treatments are only partially effective in the early to moderate stages. Neural transplantation is effective in animal models of HD and offers a potential strategy for brain repair in patients. The authors report a safety study of unilateral transplantation of human fetal striatal tissue into the striatum of four patients with HD. SUBJECTS AND METHODS: Stereotaxic placements of cell suspensions of human fetal ganglionic eminence were made unilaterally into the striatum of four patients with early to moderate HD. All patients received immunotherapy with cyclosporin A, azathioprine, and prednisolone for at least six months postoperatively. Patients were assessed for safety of the procedure using magnetic resonance imaging (MRI), regular recording of serum biochemistry and haematology to monitor immunotherapy, and clinical assessment according to the Core Assessment Protocol For Intrastriatal Transplantation in HD (CAPIT-HD). RESULTS: During the six month post-transplantation period, the only adverse events related to the procedure were associated with the immunotherapy. MRI demonstrated tissue at the site of implantation, but there was no sign of tissue overgrowth. Furthermore, there was no evidence that the procedure accelerated the course of the disease. CONCLUSIONS: Unilateral transplantation of human fetal striatal tissue in patients with HD is safe and feasible. Assessment of efficacy will require longer follow up in a larger number of patients.  (+info)

Conducting stroke research with an exception from the requirement for informed consent. (2/43)

BACKGROUND: Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. SUMMARY OF REVIEW: In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. CONCLUSIONS: Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.  (+info)

Items of concern associated with source document verification of clinical trials for new drugs. (3/43)

In the present study, we analyzed concerns of the sponsors of clinical trials regarding source document verification (SDV) procedures performed at the University of Tokyo Hospital during April 1999 and March 2001, with special focus on the differences in description between the source document and case report form (CRF). Of 132 SDV procedures (78 protocols, 496 cases), the sponsors had problematic concerns with 348 cases (70.2%) totalling 693 items, which consisted of description inconsistencies between the source documents and the CRF (41.4%), lack of description in the CRF (39.8%), and lack of description in the source documents (8.8%). The most frequently found inconsistencies between the source documents and CRF were concerning items regarding observations, laboratory examinations, and compliance, which were associated with misdescription of clinical data and/or items for evaluation in the CRF. It was also revealed that the frequent lack of description in the CRF was associated with patient history and/or complications, adverse events, and concomitant drugs and/or therapy. In contrast, the frequent lack of description in the source documents was associated with items concerning patient background, observations, and informed consent. Further, we found that submission of a report of deviation from the protocols was required for 4.0% of the claims. These results suggest the necessity of better data management during the practice of clinical trials for the purpose of maintaining the quality of clinical trials.  (+info)

Challenges in the design of antibiotic equivalency studies: the multicenter equivalency study of oral amoxicillin versus injectable penicillin in children aged 3-59 months with severe pneumonia. (4/43)

The World Health Organization (WHO) recommends that children with severe pneumonia (characterized by cough or difficult breathing, as well as lower chest wall indrawing) be hospitalized and treated with parenteral penicillin. Oral amoxicillin, if equally effective for treating severe pneumonia, would address challenges associated with providing parenteral therapy, including risk of transmission of bloodborne pathogens from contaminated needles, exposure to nosocomial pathogens during hospitalization, inadequate access to health care facilities, and cost. The recently completed multicenter international trial of oral amoxicillin versus parenteral penicillin for treatment of severe pneumonia demonstrated the equivalency of these agents in children with severe pneumonia. This article focuses on the challenges of designing an equivalence study and the threats to the validity of the trial results, particularly the implications of the bias toward finding equivalence when subjects are unlikely to respond to either study therapy. These considerations have implications for use of the Amoxicillin Penicillin Pneumonia International Study (APPIS) results in clinical practice and for potential modification of WHO treatment guidelines.  (+info)

The data monitoring experience in the MOXCON trial. (5/43)

AIMS: This article describes a challenging data monitoring experience that occurred in a major international randomized placebo-controlled trial in patients with heart failure, in which the accumulating interim data showed an excess of deaths on the active treatment. METHODS AND RESULTS: The MOXonidine CONgestive Heart Failure trial was a randomized comparison of moxonidine, a central sympathetic inhibitor, with placebo. It was planned to recruit 4500 patients with heart failure. The primary endpoint was all-cause mortality, and average follow-up was anticipated to be around 2.5 years until 724 deaths occurred. The trial Data Monitoring Board (DMB) was to conduct safety monitoring reviews of interim data at least every six months, and make their recommendations to the Executive Committee. Within a few months of the study starting, the Data Monitoring Board (DMB) observed an emerging trend of an excess of deaths on moxonidine compared with placebo. This article describes the sequence of events that unfolded: several DMB meetings to evaluate the accumulating evidence, a DMB recommendation to stop the trial, consequent dialogue with the Executive Committee and sponsor leading to a final decision to stop the trial. Ten months after the first patient was randomized, the study was stopped based on 46 versus 25 deaths in 990 moxonidine and 943 placebo patients, respectively, P=0.01. The final published evidence had 54 versus 32 deaths, P=0.012. CONCLUSIONS: This study illustrates the problems faced by a DMB, and subsequently the trial Executive Committee and sponsor, in deciding how to act in the face of an emerging (and agonizing) negative trend for mortality in a major international trial.  (+info)

Issues in data monitoring and interim analysis of trials. (6/43)

OBJECTIVES: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs). DATA SOURCES: Electronic databases. Handsearching of selected books. Personal contacts with experts in the field. REVIEW METHODS: Systematic literature reviews of DMCs and small group processes in decision-making; sample surveys of: reports of RCTs, recently completed and ongoing RCTs and policies of major organisations involved in RCTs; case studies of four DMCs; and interviews with experienced DMC members. All focused on 23 prestated questions. RESULTS: Although still a minority, RCTs increasingly have DMCs. There is wide agreement that nearly all trials need some form of data monitoring. Central to the role of the DMC is monitoring accumulating evidence related to benefit and toxicity; variation in emphasis has been reflected in the plethora of names. DMCs for trials performed for regulatory purposes should be aware of any special requirements and regulatory consequences. Advantages were identified for both larger and smaller DMCs. There is general agreement that a DMC should be independent and multidisciplinary. Consumer and ethicist membership is controversial. The chair is recognised as being particularly influential, and likely to be most effective if he or she is experienced, understands both statistical and clinical issues, and is facilitating in style and impartial. There is no evidence available to judge suggested approaches to training. The review suggested that costs should be covered, but other rewards must be so minimal as to not affect decision-making. It is usual to have a minimum frequency of DMC meetings, with evidence that face-to-face meetings are preferable. It is common to have open sessions and a closed session. A report to a DMC should cover benefits and risks in a balanced way, summarised in an accessible style, avoiding excessive detail, and be as current as possible. Disadvantages of blinded analyses seem to outweigh advantages. Information about comparable studies should be included, although interaction with the DMCs of similar ongoing trials is controversial. A range of formal statistical approaches can be used, although this is only one of a number of considerations. DMCs usually reach decisions by consensus, but other approaches are sometimes used. The general, but not unanimous, view is that DMCs should be advisory rather than executive on the basis that it is the trial organisers who are ultimately responsible for the conduct of the trial. CONCLUSIONS: Some form of data monitoring should be considered for all RCTs, with reasons given where there is no DMC or when any member is not independent. An early DMC meeting is helpful, determining roles and responsibilities; planned operations can be agreed with investigators and sponsors/funders. A template for a DMC charter is suggested. Competing interests should be declared. DMC size (commonly three to eight people) is chosen to optimise performance. Members are usually independent and drawn from appropriate backgrounds, and some, particularly the chair, are experienced. A minimum frequency of meetings is usually agreed, with flexibility for more if needed. The DMC should understand and agree the statistical approach (and guidelines) chosen, with both the DMC statistician and analysis statistician competent to apply the method. A DMC's primary purpose is to ensure that continuing a trial according to its protocol is ethical, taking account of both individual and collective ethics. A broader remit in respect of wider ethical issues is controversial; arguably, these are primarily the responsibility of research ethics committees, trial steering committees and investigators. The DMC should know the range of recommendations or decisions open to it, in advance. A record should be kept describing the key issues discussed and the rationale for decisions taken. Errors are likely to be reduced if a DMC makes a thorough review of the evidence and has a clear understanding of how it should function, there is active participation by all members, differences are resolved through discussion and there is systematic consideration of the various decision options. DMCs should be encouraged to comment on draft final trial reports. These should include information about the data monitoring process and detail the DMC membership. It is recommended that groups responsible for data monitoring be given the standard name 'Data Monitoring Committee' (DMC). Areas for further research include: widening DMC membership beyond clinicians, trialists and statisticians; initiatives to train DMC members; methods of DMC decision-making; 'open' data monitoring; DMCs covering a portfolio of trials rather than single trials; DMC size and membership, incorporating issues of group dynamics; empirical study of the workings of DMCs and their decision-making, and which trials should or should not have a DMC.  (+info)

Preliminary data release for randomized clinical trials of noninferiority: a new proposal. (7/43)

Noninferiority trials often require a long follow-up period for the data to reach the maturity needed for definitive analysis. A proposal is presented that allows for early release of outcome data from a carefully specified subset of noninferiority trials. This subset is defined so that the early release of the data will be potentially useful to patients who face a treatment decision but will not compromise the integrity of the trial or interfere with the completion of the trial to its definitive analysis. In particular, the release of the data will only occur after the last participant has been randomly assigned and is off treatment-arm-specific therapy and only if it is unlikely that subsequent treatment and/or follow-up practices will change based on the knowledge of released data. In contrast to standard interim monitoring, (1) the release of the data would be automatic and independent of the observed data, and (2) the trial would continue on to its planned final analysis and not be stopped. Examples are given demonstrating how the proposal would work, along with a discussion of possible objections to the proposal.  (+info)

Randomized trials stopped early for harm in HIV/AIDS: a systematic survey. (8/43)

PURPOSE: The decision to stop trials early because of the harmful effects of the intervention is complex and requires weighing statistical, logistical, and ethical considerations. We assessed the prevalence of randomized clinical trials (RCTs) stopped early for harm in HIV/AIDS and determined the quality of reporting of methods to inform the decision to stop the trial. METHOD: We searched 11 electronic databases and major conference abstract databases, contacted trialist and advocacy groups, and searched the Internet. We selected RCTs stopped early for harm. We extracted data on journal and year of publication, reporting of methods and funding, planned sample size, number and planning of interim analyses, stopping rules, and effect size of the harm outcomes. RESULTS: We found 10 RCTs stopped early for harm (median, n = 85; range, 7-1227). Most interventions (n = 9) were antiviral drugs; one trial studied vitamins to prevent vertical transmission of HIV. Five studies reported a priori defined adverse events, and only 1 trial reported planned stopping guidelines. The primary harm outcomes reported across trials included toxicity, death, and increased mother-to-child transmission. Two trials were stopped due to sudden unanticipated adverse events (Stevens-Johnson syndrome, death, and encephalopathy). Relative risk point estimates for harm ranged from 1 to 6.18. Six studies reported the presence of a data safety and monitoring board. CONCLUSION: The reporting of methods to inform the decision to stop trials for harm in this population is deficient in a variety of ways, including lack of stopping guidelines. Clinicians should interpret RCTs stopped early for harm with caution and interpret the results in light of related evidence. Trialists should improve the transparency of their decision-making regarding early stopping for harmful effects.  (+info)

Clinical trials are research studies that involve human participants and are designed to evaluate the safety and efficacy of new medical treatments, drugs, devices, or behavioral interventions. The purpose of clinical trials is to determine whether a new intervention is safe, effective, and beneficial for patients, as well as to compare it with currently available treatments. Clinical trials follow a series of phases, each with specific goals and criteria, before a new intervention can be approved by regulatory authorities for widespread use.

Clinical trials are conducted according to a protocol, which is a detailed plan that outlines the study's objectives, design, methodology, statistical analysis, and ethical considerations. The protocol is developed and reviewed by a team of medical experts, statisticians, and ethicists, and it must be approved by an institutional review board (IRB) before the trial can begin.

Participation in clinical trials is voluntary, and participants must provide informed consent before enrolling in the study. Informed consent involves providing potential participants with detailed information about the study's purpose, procedures, risks, benefits, and alternatives, as well as their rights as research subjects. Participants can withdraw from the study at any time without penalty or loss of benefits to which they are entitled.

Clinical trials are essential for advancing medical knowledge and improving patient care. They help researchers identify new treatments, diagnostic tools, and prevention strategies that can benefit patients and improve public health. However, clinical trials also pose potential risks to participants, including adverse effects from experimental interventions, time commitment, and inconvenience. Therefore, it is important for researchers to carefully design and conduct clinical trials to minimize risks and ensure that the benefits outweigh the risks.

A randomized controlled trial (RCT) is a type of clinical study in which participants are randomly assigned to receive either the experimental intervention or the control condition, which may be a standard of care, placebo, or no treatment. The goal of an RCT is to minimize bias and ensure that the results are due to the intervention being tested rather than other factors. This design allows for a comparison between the two groups to determine if there is a significant difference in outcomes. RCTs are often considered the gold standard for evaluating the safety and efficacy of medical interventions, as they provide a high level of evidence for causal relationships between the intervention and health outcomes.

A Clinical Trials Data Monitoring Committee (DTMC), also known as a Data and Safety Monitoring Board (DSMB), is a group of independent experts that oversees the safety and efficacy data of a clinical trial. The committee's primary role is to protect the interests of the study participants and ensure the integrity of the trial by regularly reviewing accumulating data during the trial.

The DTMC typically includes clinicians, statisticians, and other experts who are not involved in the design or conduct of the trial. They review unblinded data from the trial to assess whether any safety concerns have arisen, such as unexpected adverse events, or whether there is evidence that the experimental intervention is significantly more effective or harmful than the control group.

Based on their review, the DTMC may recommend changes to the trial protocol, such as modifying the dose of the experimental intervention, adding or removing study sites, or stopping the trial early if there is clear evidence of benefit or harm. The committee's recommendations are typically confidential and only shared with the trial sponsor and regulatory authorities.

Overall, the role of a DTMC is to ensure that clinical trials are conducted ethically and responsibly, with the safety and well-being of study participants as the top priority.

Treatment outcome is a term used to describe the result or effect of medical treatment on a patient's health status. It can be measured in various ways, such as through symptoms improvement, disease remission, reduced disability, improved quality of life, or survival rates. The treatment outcome helps healthcare providers evaluate the effectiveness of a particular treatment plan and make informed decisions about future care. It is also used in clinical research to compare the efficacy of different treatments and improve patient care.

Phase III clinical trials are a type of medical research study that involves testing the safety and efficacy of a new drug, device, or treatment in a large group of people. These studies typically enroll hundreds to thousands of participants, who are randomly assigned to receive either the experimental treatment or a standard of care comparison group.

The primary goal of Phase III clinical trials is to determine whether the new treatment works better than existing treatments and to assess its safety and side effects in a larger population. The data collected from these studies can help regulatory agencies like the U.S. Food and Drug Administration (FDA) decide whether to approve the new treatment for use in the general population.

Phase III clinical trials are usually conducted at multiple centers, often across different countries, to ensure that the results are generalizable to a wide range of patients. Participants may be followed for several years to assess long-term safety and efficacy outcomes.

Overall, Phase III clinical trials play a critical role in ensuring that new treatments are safe and effective before they become widely available to patients.

Cost-benefit analysis (CBA) is a systematic process used to compare the costs and benefits of different options to determine which one provides the greatest net benefit. In a medical context, CBA can be used to evaluate the value of medical interventions, treatments, or policies by estimating and monetizing all the relevant costs and benefits associated with each option.

The costs included in a CBA may include direct costs such as the cost of the intervention or treatment itself, as well as indirect costs such as lost productivity or time away from work. Benefits may include improved health outcomes, reduced morbidity or mortality, and increased quality of life.

Once all the relevant costs and benefits have been identified and quantified, they are typically expressed in monetary terms to allow for a direct comparison. The option with the highest net benefit (i.e., the difference between total benefits and total costs) is considered the most cost-effective.

It's important to note that CBA has some limitations and can be subject to various biases and assumptions, so it should be used in conjunction with other evaluation methods to ensure a comprehensive understanding of the value of medical interventions or policies.

The "drug industry" is also commonly referred to as the "pharmaceutical industry." It is a segment of the healthcare sector that involves the research, development, production, and marketing of medications or drugs. This includes both prescription and over-the-counter medicines used to treat, cure, or prevent diseases and medical conditions in humans and animals.

The drug industry comprises various types of organizations, such as:

1. Research-based pharmaceutical companies: These are large corporations that focus on the research and development (R&D) of new drugs, clinical trials, obtaining regulatory approvals, manufacturing, and marketing their products globally. Examples include Pfizer, Johnson & Johnson, Roche, and Merck.

2. Generic drug manufacturers: After the patent for a brand-name drug expires, generic drug manufacturers can produce and sell a similar version of the drug at a lower cost. These companies must demonstrate that their product is bioequivalent to the brand-name drug in terms of safety, quality, and efficacy.

3. Biotechnology companies: These firms specialize in developing drugs using biotechnological methods, such as recombinant DNA technology, gene therapy, or monoclonal antibodies. Many biotech companies focus on specific therapeutic areas, like oncology, immunology, or neurology.

4. Contract research organizations (CROs): CROs provide various services to the drug industry, including clinical trial management, data analysis, regulatory affairs support, and pharmacovigilance. They work with both large pharmaceutical companies and smaller biotech firms to help streamline the drug development process.

5. Drug delivery system companies: These organizations focus on developing innovative technologies for delivering drugs more effectively and safely to patients. Examples include transdermal patches, inhalers, or long-acting injectables.

6. Wholesalers and distributors: Companies that purchase drugs from manufacturers and distribute them to pharmacies, hospitals, and other healthcare providers.

The drug industry plays a crucial role in improving public health by discovering, developing, and delivering new treatments for various diseases and medical conditions. However, it is also subject to criticism and regulation due to concerns about high drug prices, marketing practices, and the potential for conflicts of interest between industry and healthcare professionals.

Economic models in the context of healthcare and medicine are theoretical frameworks used to analyze and predict the economic impact and cost-effectiveness of healthcare interventions, treatments, or policies. These models utilize clinical and epidemiological data, as well as information on resource use and costs, to estimate outcomes such as quality-adjusted life years (QALYs) gained, incremental cost-effectiveness ratios (ICERs), and budget impacts. The purpose of economic models is to inform decision-making and allocate resources in an efficient and evidence-based manner. Examples of economic models include decision tree analysis, Markov models, and simulation models.

"Drug costs" refer to the amount of money that must be paid to acquire and use a particular medication. These costs can include the following:

1. The actual purchase price of the drug, which may vary depending on factors such as the dosage form, strength, and quantity of the medication, as well as whether it is obtained through a retail pharmacy, mail-order service, or other distribution channel.
2. Any additional fees or charges associated with obtaining the drug, such as shipping and handling costs, insurance copayments or coinsurance amounts, and deductibles.
3. The cost of any necessary medical services or supplies that are required to administer the drug, such as syringes, needles, or alcohol swabs for injectable medications, or nebulizers for inhaled drugs.
4. The cost of monitoring and managing any potential side effects or complications associated with the use of the drug, which may include additional medical appointments, laboratory tests, or other diagnostic procedures.

It is important to note that drug costs can vary widely depending on a variety of factors, including the patient's insurance coverage, the pharmacy where the drug is obtained, and any discounts or rebates that may be available. Patients are encouraged to shop around for the best prices and to explore all available options for reducing their out-of-pocket costs, such as using generic medications or participating in manufacturer savings programs.

Statistical data interpretation involves analyzing and interpreting numerical data in order to identify trends, patterns, and relationships. This process often involves the use of statistical methods and tools to organize, summarize, and draw conclusions from the data. The goal is to extract meaningful insights that can inform decision-making, hypothesis testing, or further research.

In medical contexts, statistical data interpretation is used to analyze and make sense of large sets of clinical data, such as patient outcomes, treatment effectiveness, or disease prevalence. This information can help healthcare professionals and researchers better understand the relationships between various factors that impact health outcomes, develop more effective treatments, and identify areas for further study.

Some common statistical methods used in data interpretation include descriptive statistics (e.g., mean, median, mode), inferential statistics (e.g., hypothesis testing, confidence intervals), and regression analysis (e.g., linear, logistic). These methods can help medical professionals identify patterns and trends in the data, assess the significance of their findings, and make evidence-based recommendations for patient care or public health policy.

A research design in medical or healthcare research is a systematic plan that guides the execution and reporting of research to address a specific research question or objective. It outlines the overall strategy for collecting, analyzing, and interpreting data to draw valid conclusions. The design includes details about the type of study (e.g., experimental, observational), sampling methods, data collection techniques, data analysis approaches, and any potential sources of bias or confounding that need to be controlled for. A well-defined research design helps ensure that the results are reliable, generalizable, and relevant to the research question, ultimately contributing to evidence-based practice in medicine and healthcare.

Ethics committees, also known as institutional review boards (IRBs), are groups responsible for reviewing and approving research studies involving human subjects. The primary goal of these committees is to ensure that the rights and welfare of study participants are protected, and that the research is conducted in an ethical manner.

Ethics committees typically consist of a diverse group of individuals with expertise in various fields, such as medicine, law, ethics, and community representation. They review the proposed research protocol, informed consent documents, and other relevant materials to ensure that they meet ethical standards and regulations.

The committee assesses several key factors when reviewing a study, including:

1. Risks vs. benefits: The potential risks of the study must be minimized and reasonable in relation to the anticipated benefits.
2. Informed consent: Participants must be adequately informed about the study's purpose, procedures, risks, and benefits, and provide their voluntary consent.
3. Selection and recruitment: Participants should be selected fairly and without discrimination, and recruitment methods should be unbiased.
4. Confidentiality: The privacy and confidentiality of participants' information must be protected throughout the study.
5. Monitoring and reporting: There should be mechanisms in place for monitoring the study's progress and ensuring that any adverse events are reported and addressed promptly.

Ethics committees play a critical role in protecting human subjects and upholding ethical standards in research. They provide oversight and guidance to researchers, helping to ensure that studies are conducted with integrity and respect for participants' rights and welfare.

I'm sorry for any confusion, but "United States" is a geopolitical entity, specifically the name of the country consisting of 50 states, and it is not a medical term or concept. Therefore, I can't provide a medical definition for it. If you have any questions related to health, medicine, or biology, I would be happy to try to help answer those!

Combination drug therapy is a treatment approach that involves the use of multiple medications with different mechanisms of action to achieve better therapeutic outcomes. This approach is often used in the management of complex medical conditions such as cancer, HIV/AIDS, and cardiovascular diseases. The goal of combination drug therapy is to improve efficacy, reduce the risk of drug resistance, decrease the likelihood of adverse effects, and enhance the overall quality of life for patients.

In combining drugs, healthcare providers aim to target various pathways involved in the disease process, which may help to:

1. Increase the effectiveness of treatment by attacking the disease from multiple angles.
2. Decrease the dosage of individual medications, reducing the risk and severity of side effects.
3. Slow down or prevent the development of drug resistance, a common problem in chronic diseases like HIV/AIDS and cancer.
4. Improve patient compliance by simplifying dosing schedules and reducing pill burden.

Examples of combination drug therapy include:

1. Antiretroviral therapy (ART) for HIV treatment, which typically involves three or more drugs from different classes to suppress viral replication and prevent the development of drug resistance.
2. Chemotherapy regimens for cancer treatment, where multiple cytotoxic agents are used to target various stages of the cell cycle and reduce the likelihood of tumor cells developing resistance.
3. Cardiovascular disease management, which may involve combining medications such as angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, diuretics, and statins to control blood pressure, heart rate, fluid balance, and cholesterol levels.
4. Treatment of tuberculosis, which often involves a combination of several antibiotics to target different aspects of the bacterial life cycle and prevent the development of drug-resistant strains.

When prescribing combination drug therapy, healthcare providers must carefully consider factors such as potential drug interactions, dosing schedules, adverse effects, and contraindications to ensure safe and effective treatment. Regular monitoring of patients is essential to assess treatment response, manage side effects, and adjust the treatment plan as needed.

Committee membership, in a medical context, refers to the role of an individual serving on a committee that is responsible for making decisions or providing guidance related to medical issues or healthcare delivery. This could include committees within a hospital or healthcare organization, professional medical societies, or governmental bodies. Committee members may be involved in developing policies, guidelines, or standards; overseeing research or quality improvement initiatives; or addressing ethical or regulatory concerns. Membership on such committees is often composed of medical professionals with relevant expertise and experience.

Advisory committees, in the context of medicine and healthcare, are groups of experts that provide guidance and recommendations to organizations or governmental bodies on medical and health-related matters. These committees typically consist of physicians, researchers, scientists, and other healthcare professionals who have expertise in a specific area.

Their roles can include:

1. Providing expert advice on clinical guidelines, treatment protocols, and diagnostic criteria.
2. Evaluating the safety and efficacy of medical products, such as drugs and devices.
3. Making recommendations on public health policies and regulations.
4. Assessing the impact of new research findings on clinical practice.
5. Providing education and training to healthcare professionals.

Advisory committees can be found at various levels, including within hospitals and medical institutions, as well as at the state and federal level. Their recommendations are intended to help inform decision-making and improve the quality of care delivered to patients. However, it's important to note that these committees do not have legislative or regulatory authority, and their recommendations are non-binding.

In the field of medicine, "time factors" refer to the duration of symptoms or time elapsed since the onset of a medical condition, which can have significant implications for diagnosis and treatment. Understanding time factors is crucial in determining the progression of a disease, evaluating the effectiveness of treatments, and making critical decisions regarding patient care.

For example, in stroke management, "time is brain," meaning that rapid intervention within a specific time frame (usually within 4.5 hours) is essential to administering tissue plasminogen activator (tPA), a clot-busting drug that can minimize brain damage and improve patient outcomes. Similarly, in trauma care, the "golden hour" concept emphasizes the importance of providing definitive care within the first 60 minutes after injury to increase survival rates and reduce morbidity.

Time factors also play a role in monitoring the progression of chronic conditions like diabetes or heart disease, where regular follow-ups and assessments help determine appropriate treatment adjustments and prevent complications. In infectious diseases, time factors are crucial for initiating antibiotic therapy and identifying potential outbreaks to control their spread.

Overall, "time factors" encompass the significance of recognizing and acting promptly in various medical scenarios to optimize patient outcomes and provide effective care.

An Ethics Committee for Research, also known as an Institutional Review Board (IRB), is a group that has been formally designated to review, approve, monitor, and revise biomedical and behavioral research involving humans. The purpose of the committee is to ensure that the rights and welfare of the participants are protected and that the risks involved in the research are minimized and reasonable in relation to the anticipated benefits.

The committee typically includes members with various backgrounds, including scientists, non-scientists, and community members. They review the research protocol, informed consent documents, and any other relevant materials to ensure that they meet ethical standards and regulations. The committee also monitors the progress of the research to ensure that it continues to be conducted in an ethical manner.

The role of ethics committees for research is critical in protecting human subjects from harm and ensuring that research is conducted with integrity, respect, and transparency.

Risk assessment in the medical context refers to the process of identifying, evaluating, and prioritizing risks to patients, healthcare workers, or the community related to healthcare delivery. It involves determining the likelihood and potential impact of adverse events or hazards, such as infectious diseases, medication errors, or medical devices failures, and implementing measures to mitigate or manage those risks. The goal of risk assessment is to promote safe and high-quality care by identifying areas for improvement and taking action to minimize harm.

Neoplasms are abnormal growths of cells or tissues in the body that serve no physiological function. They can be benign (non-cancerous) or malignant (cancerous). Benign neoplasms are typically slow growing and do not spread to other parts of the body, while malignant neoplasms are aggressive, invasive, and can metastasize to distant sites.

Neoplasms occur when there is a dysregulation in the normal process of cell division and differentiation, leading to uncontrolled growth and accumulation of cells. This can result from genetic mutations or other factors such as viral infections, environmental exposures, or hormonal imbalances.

Neoplasms can develop in any organ or tissue of the body and can cause various symptoms depending on their size, location, and type. Treatment options for neoplasms include surgery, radiation therapy, chemotherapy, immunotherapy, and targeted therapy, among others.

A Severity of Illness Index is a measurement tool used in healthcare to assess the severity of a patient's condition and the risk of mortality or other adverse outcomes. These indices typically take into account various physiological and clinical variables, such as vital signs, laboratory values, and co-morbidities, to generate a score that reflects the patient's overall illness severity.

Examples of Severity of Illness Indices include the Acute Physiology and Chronic Health Evaluation (APACHE) system, the Simplified Acute Physiology Score (SAPS), and the Mortality Probability Model (MPM). These indices are often used in critical care settings to guide clinical decision-making, inform prognosis, and compare outcomes across different patient populations.

It is important to note that while these indices can provide valuable information about a patient's condition, they should not be used as the sole basis for clinical decision-making. Rather, they should be considered in conjunction with other factors, such as the patient's overall clinical presentation, treatment preferences, and goals of care.

Antineoplastic agents are a class of drugs used to treat malignant neoplasms or cancer. These agents work by inhibiting the growth and proliferation of cancer cells, either by killing them or preventing their division and replication. Antineoplastic agents can be classified based on their mechanism of action, such as alkylating agents, antimetabolites, topoisomerase inhibitors, mitotic inhibitors, and targeted therapy agents.

Alkylating agents work by adding alkyl groups to DNA, which can cause cross-linking of DNA strands and ultimately lead to cell death. Antimetabolites interfere with the metabolic processes necessary for DNA synthesis and replication, while topoisomerase inhibitors prevent the relaxation of supercoiled DNA during replication. Mitotic inhibitors disrupt the normal functioning of the mitotic spindle, which is essential for cell division. Targeted therapy agents are designed to target specific molecular abnormalities in cancer cells, such as mutated oncogenes or dysregulated signaling pathways.

It's important to note that antineoplastic agents can also affect normal cells and tissues, leading to various side effects such as nausea, vomiting, hair loss, and myelosuppression (suppression of bone marrow function). Therefore, the use of these drugs requires careful monitoring and management of their potential adverse effects.

I'm sorry for any confusion, but "Professional Staff Committees" is not a medical term or concept. Instead, it likely refers to committees made up of professional staff members in a hospital, healthcare organization, or other professional setting. These committees typically consist of department heads, managers, and other experienced professionals who collaborate on various aspects of organizational operations, such as policy-making, quality improvement, patient care standards, and staff development. They serve as platforms for discussion, decision-making, and problem-solving to ensure the smooth functioning and continuous improvement of the organization's services.

Medical Definition:

"Risk factors" are any attribute, characteristic or exposure of an individual that increases the likelihood of developing a disease or injury. They can be divided into modifiable and non-modifiable risk factors. Modifiable risk factors are those that can be changed through lifestyle choices or medical treatment, while non-modifiable risk factors are inherent traits such as age, gender, or genetic predisposition. Examples of modifiable risk factors include smoking, alcohol consumption, physical inactivity, and unhealthy diet, while non-modifiable risk factors include age, sex, and family history. It is important to note that having a risk factor does not guarantee that a person will develop the disease, but rather indicates an increased susceptibility.

An Ethics Committee in a clinical setting, also known as an Institutional Review Board (IRB), is a group that reviews and monitors biomedical and behavioral research involving humans to ensure that it is conducted ethically. The committee's role is to protect the rights and welfare of human subjects by ensuring that the risks of participation in research are minimized and that the potential benefits of the research are maximized.

The committee reviews the proposed research protocol, informed consent documents, and other study-related materials to ensure that they meet ethical standards and comply with federal regulations. The committee also monitors the conduct of the research to ensure that it is being carried out in accordance with the approved protocol and that any adverse events are reported and addressed promptly.

The members of an Ethics Committee typically include physicians, nurses, scientists, ethicists, and community members, and they may also seek input from other experts as needed. The committee operates independently of the researcher and has the authority to approve, require modifications to, or disapprove the research.

The double-blind method is a study design commonly used in research, including clinical trials, to minimize bias and ensure the objectivity of results. In this approach, both the participants and the researchers are unaware of which group the participants are assigned to, whether it be the experimental group or the control group. This means that neither the participants nor the researchers know who is receiving a particular treatment or placebo, thus reducing the potential for bias in the evaluation of outcomes. The assignment of participants to groups is typically done by a third party not involved in the study, and the codes are only revealed after all data have been collected and analyzed.

A multicenter study is a type of clinical research study that involves multiple centers or institutions. These studies are often conducted to increase the sample size and diversity of the study population, which can improve the generalizability of the study results. In a multicenter study, data is collected from participants at multiple sites and then analyzed together to identify patterns, trends, and relationships in the data. This type of study design can be particularly useful for researching rare diseases or conditions, or for testing new treatments or interventions that require a large number of participants.

Multicenter studies can be either interventional (where participants are randomly assigned to receive different treatments or interventions) or observational (where researchers collect data on participants' characteristics and outcomes without intervening). In both cases, it is important to ensure standardization of data collection and analysis procedures across all study sites to minimize bias and ensure the validity and reliability of the results.

Multicenter studies can provide valuable insights into the effectiveness and safety of new treatments or interventions, as well as contribute to our understanding of disease mechanisms and risk factors. However, they can also be complex and expensive to conduct, requiring careful planning, coordination, and management to ensure their success.

An ethical review is the process of evaluating and assessing a research study or project that involves human participants, medical interventions, or personal data, to ensure that it is conducted in accordance with ethical principles and standards. The purpose of an ethical review is to protect the rights and welfare of the participants and to minimize any potential harm or risks associated with the research.

The ethical review is typically conducted by an independent committee called an Institutional Review Board (IRB), Research Ethics Committee (REC), or Ethics Review Board (ERB). The committee reviews the study protocol, informed consent procedures, recruitment methods, data collection and management plans, and potential conflicts of interest.

The ethical review process is guided by several key principles, including respect for persons, beneficence, and justice. These principles require that researchers obtain informed consent from participants, avoid causing harm, minimize risks, maximize benefits, and ensure fairness in the selection and treatment of research participants.

Overall, an ethical review is a critical component of responsible conduct in research and helps to ensure that studies are conducted with integrity, transparency, and respect for the rights and welfare of human participants.

Phase II clinical trials are a type of medical research study that aims to assess the safety and effectiveness of a new drug or intervention in a specific patient population. These studies typically follow successful completion of Phase I clinical trials, which focus primarily on evaluating the safety and dosage of the treatment in a small group of healthy volunteers.

In Phase II clinical trials, the treatment is tested in a larger group of patients (usually several hundred) who have the condition or disease that the treatment is intended to treat. The main goals of these studies are to:

1. Determine the optimal dosage range for the treatment
2. Evaluate the safety and side effects of the treatment at different doses
3. Assess how well the treatment works in treating the target condition or disease

Phase II clinical trials are typically randomized, controlled studies, meaning that participants are randomly assigned to receive either the new treatment or a comparison group, such as a placebo or standard of care. The study is also often blinded, meaning that neither the participants nor the researchers know who is receiving which treatment. This helps to minimize bias and ensure that the results are due to the treatment itself rather than other factors.

Overall, Phase II clinical trials play an important role in determining whether a new drug or intervention is safe and effective enough to move on to larger, more expensive Phase III clinical trials, which involve even larger groups of patients and are designed to confirm and expand upon the results of Phase II studies.

A Pharmacy and Therapeutics (P&T) Committee is a group of healthcare professionals, typically including physicians, pharmacists, and other experts, responsible for the evaluation, recommendation, and monitoring of safe and effective medication use within a healthcare system or organization. They make decisions about the formulary, which is the list of medications that are covered and approved for use within that system. The committee also develops guidelines and policies for medication prescribing, administering, and monitoring to promote quality patient care, reduce medication errors, and control costs.

Animal Care Committees (ACCs), also known as Institutional Animal Care and Use Committees (IACUCs) in the United States, are committees required by regulations to oversee the humane treatment and use of animals in research and teaching at institutions such as universities, hospitals, and pharmaceutical companies.

The main responsibilities of ACCs include reviewing and approving animal use protocols, inspecting animal facilities and laboratories, ensuring compliance with relevant policies and regulations, and providing training and education to researchers and staff on the ethical treatment of animals. The members of ACCs typically include veterinarians, scientists, non-scientists, and community members who can provide a balanced perspective on the use of animals in research and teaching.

Phase I clinical trials are the first stage of testing a new medical treatment or intervention in human subjects. The primary goal of a Phase I trial is to evaluate the safety and tolerability of the experimental treatment, as well as to determine an appropriate dosage range. These studies typically involve a small number of healthy volunteers or patients with the condition of interest, and are designed to assess the pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes the drug) and pharmacodynamics (the biological effects of the drug on the body) of the experimental treatment. Phase I trials may also provide initial evidence of efficacy, but this is not their primary objective. Overall, the data from Phase I trials help researchers determine whether it is safe to proceed to larger-scale testing in Phase II clinical trials.

Evidence-Based Medicine (EBM) is a medical approach that combines the best available scientific evidence with clinical expertise and patient values to make informed decisions about diagnosis, treatment, and prevention of diseases. It emphasizes the use of systematic research, including randomized controlled trials and meta-analyses, to guide clinical decision making. EBM aims to provide the most effective and efficient care while minimizing variations in practice, reducing errors, and improving patient outcomes.

Patient selection, in the context of medical treatment or clinical research, refers to the process of identifying and choosing appropriate individuals who are most likely to benefit from a particular medical intervention or who meet specific criteria to participate in a study. This decision is based on various factors such as the patient's diagnosis, stage of disease, overall health status, potential risks, and expected benefits. The goal of patient selection is to ensure that the selected individuals will receive the most effective and safe care possible while also contributing to meaningful research outcomes.

Controlled clinical trials are a type of medical research study that compare the effects of one or more interventions (e.g., drugs, treatments, or procedures) to a standard of care or placebo in a group of participants who have a specific medical condition. These studies are designed to determine whether an intervention is safe and effective, and they typically involve randomly assigning participants to receive either the experimental intervention or the control.

In a controlled clinical trial, the researchers carefully control and monitor all aspects of the study to minimize bias and ensure that the results are as reliable and valid as possible. This may include using standardized measures to assess outcomes, blinding participants and researchers to treatment assignments, and analyzing data using statistical methods.

Controlled clinical trials are an important part of the process for developing and approving new medical treatments and interventions. They provide valuable information about the safety and efficacy of these interventions, and help to ensure that they are safe and effective for use in clinical practice.

A placebo is a substance or treatment that has no inherent therapeutic effect. It is often used in clinical trials as a control against which the effects of a new drug or therapy can be compared. Placebos are typically made to resemble the active treatment, such as a sugar pill for a medication trial, so that participants cannot tell the difference between what they are receiving and the actual treatment.

The placebo effect refers to the phenomenon where patients experience real improvements in their symptoms or conditions even when given a placebo. This may be due to psychological factors such as belief in the effectiveness of the treatment, suggestion, or conditioning. The placebo effect is often used as a comparison group in clinical trials to help determine if the active treatment has a greater effect than no treatment at all.

Quality-Adjusted Life Years (QALYs) is a measure of health outcomes that combines both the quality and quantity of life lived in a single metric. It is often used in economic evaluations of healthcare interventions to estimate their value for money. QALYs are calculated by multiplying the number of years of life gained by a weighting factor that reflects the quality of life experienced during those years, typically on a scale from 0 (representing death) to 1 (representing perfect health). For example, if a healthcare intervention extends a person's life by an additional five years but they experience only 80% of full health during that time, the QALY gain would be 4 (5 x 0.8). This measure allows for comparisons to be made between different interventions and their impact on both length and quality of life.

"Endpoint determination" is a medical term that refers to the process of deciding when a clinical trial or study should be stopped or concluded based on the outcomes or results that have been observed. The endpoint of a study is the primary outcome or result that the study is designed to investigate and measure.

In endpoint determination, researchers use pre-specified criteria, such as statistical significance levels or safety concerns, to evaluate whether the study has met its objectives or if there are any significant benefits or risks associated with the intervention being studied. The decision to end a study early can be based on various factors, including the achievement of a predefined level of efficacy, the emergence of unexpected safety issues, or the realization that the study is unlikely to achieve its intended goals.

Endpoint determination is an important aspect of clinical trial design and conduct, as it helps ensure that studies are conducted in an ethical and scientifically rigorous manner, and that their results can be used to inform medical practice and policy.

"Access to information," in a medical context, refers to the ability of individuals, patients, healthcare providers, and researchers to obtain, request, and disseminate health-related data, records, research findings, and other important information. This includes access to personal medical records, clinical trial results, evidence-based practices, and public health statistics.

Promoting access to information is crucial for informed decision-making, ensuring transparency, advancing medical research, improving patient care, and enhancing overall healthcare system performance. Various laws, regulations, and policies at the local, national, and international levels aim to protect and facilitate access to information while balancing privacy concerns, data security, and intellectual property rights.

Prospective studies, also known as longitudinal studies, are a type of cohort study in which data is collected forward in time, following a group of individuals who share a common characteristic or exposure over a period of time. The researchers clearly define the study population and exposure of interest at the beginning of the study and follow up with the participants to determine the outcomes that develop over time. This type of study design allows for the investigation of causal relationships between exposures and outcomes, as well as the identification of risk factors and the estimation of disease incidence rates. Prospective studies are particularly useful in epidemiology and medical research when studying diseases with long latency periods or rare outcomes.

Follow-up studies are a type of longitudinal research that involve repeated observations or measurements of the same variables over a period of time, in order to understand their long-term effects or outcomes. In medical context, follow-up studies are often used to evaluate the safety and efficacy of medical treatments, interventions, or procedures.

In a typical follow-up study, a group of individuals (called a cohort) who have received a particular treatment or intervention are identified and then followed over time through periodic assessments or data collection. The data collected may include information on clinical outcomes, adverse events, changes in symptoms or functional status, and other relevant measures.

The results of follow-up studies can provide important insights into the long-term benefits and risks of medical interventions, as well as help to identify factors that may influence treatment effectiveness or patient outcomes. However, it is important to note that follow-up studies can be subject to various biases and limitations, such as loss to follow-up, recall bias, and changes in clinical practice over time, which must be carefully considered when interpreting the results.

Practice guidelines, also known as clinical practice guidelines, are systematically developed statements that aim to assist healthcare professionals and patients in making informed decisions about appropriate health care for specific clinical circumstances. They are based on a thorough evaluation of the available scientific evidence, consensus of expert opinion, and consideration of patient preferences. Practice guidelines can cover a wide range of topics, including diagnosis, management, prevention, and treatment options for various medical conditions. They are intended to improve the quality and consistency of care, reduce unnecessary variations in practice, and promote evidence-based medicine. However, they should not replace clinical judgment or individualized patient care.

Clinical protocols, also known as clinical practice guidelines or care paths, are systematically developed statements that assist healthcare professionals and patients in making decisions about the appropriate healthcare for specific clinical circumstances. They are based on a thorough evaluation of the available scientific evidence and consist of a set of recommendations that are designed to optimize patient outcomes, improve the quality of care, and reduce unnecessary variations in practice. Clinical protocols may cover a wide range of topics, including diagnosis, treatment, follow-up, and disease prevention, and are developed by professional organizations, government agencies, and other groups with expertise in the relevant field.

Reproducibility of results in a medical context refers to the ability to obtain consistent and comparable findings when a particular experiment or study is repeated, either by the same researcher or by different researchers, following the same experimental protocol. It is an essential principle in scientific research that helps to ensure the validity and reliability of research findings.

In medical research, reproducibility of results is crucial for establishing the effectiveness and safety of new treatments, interventions, or diagnostic tools. It involves conducting well-designed studies with adequate sample sizes, appropriate statistical analyses, and transparent reporting of methods and findings to allow other researchers to replicate the study and confirm or refute the results.

The lack of reproducibility in medical research has become a significant concern in recent years, as several high-profile studies have failed to produce consistent findings when replicated by other researchers. This has led to increased scrutiny of research practices and a call for greater transparency, rigor, and standardization in the conduct and reporting of medical research.

Survival analysis is a branch of statistics that deals with the analysis of time to event data. It is used to estimate the time it takes for a certain event of interest to occur, such as death, disease recurrence, or treatment failure. The event of interest is called the "failure" event, and survival analysis estimates the probability of not experiencing the failure event until a certain point in time, also known as the "survival" probability.

Survival analysis can provide important information about the effectiveness of treatments, the prognosis of patients, and the identification of risk factors associated with the event of interest. It can handle censored data, which is common in medical research where some participants may drop out or be lost to follow-up before the event of interest occurs.

Survival analysis typically involves estimating the survival function, which describes the probability of surviving beyond a certain time point, as well as hazard functions, which describe the instantaneous rate of failure at a given time point. Other important concepts in survival analysis include median survival times, restricted mean survival times, and various statistical tests to compare survival curves between groups.

A "Drug Administration Schedule" refers to the plan for when and how a medication should be given to a patient. It includes details such as the dose, frequency (how often it should be taken), route (how it should be administered, such as orally, intravenously, etc.), and duration (how long it should be taken) of the medication. This schedule is often created and prescribed by healthcare professionals, such as doctors or pharmacists, to ensure that the medication is taken safely and effectively. It may also include instructions for missed doses or changes in the dosage.

Quality of Life (QOL) is a broad, multidimensional concept that usually includes an individual's physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationship to salient features of their environment. It reflects the impact of disease and treatment on a patient's overall well-being and ability to function in daily life.

The World Health Organization (WHO) defines QOL as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns." It is a subjective concept, meaning it can vary greatly from person to person.

In healthcare, QOL is often used as an outcome measure in clinical trials and other research studies to assess the impact of interventions or treatments on overall patient well-being.

Medical societies are professional organizations composed of physicians, surgeons, and other healthcare professionals who share a common purpose of promoting medical research, education, and patient care. These societies can focus on specific medical specialties, such as the American Society of Clinical Oncology (ASCO) for cancer specialists or the American College of Surgeons (ACS) for surgeons. They may also address broader issues related to healthcare policy, advocacy, and ethics. Medical societies often provide resources for continuing medical education, publish scientific journals, establish clinical practice guidelines, and offer networking opportunities for members.

A stroke, also known as cerebrovascular accident (CVA), is a serious medical condition that occurs when the blood supply to part of the brain is interrupted or reduced, leading to deprivation of oxygen and nutrients to brain cells. This can result in the death of brain tissue and cause permanent damage or temporary impairment to cognitive functions, speech, memory, movement, and other body functions controlled by the affected area of the brain.

Strokes can be caused by either a blockage in an artery that supplies blood to the brain (ischemic stroke) or the rupture of a blood vessel in the brain (hemorrhagic stroke). A transient ischemic attack (TIA), also known as a "mini-stroke," is a temporary disruption of blood flow to the brain that lasts only a few minutes and does not cause permanent damage.

Symptoms of a stroke may include sudden weakness or numbness in the face, arm, or leg; difficulty speaking or understanding speech; vision problems; loss of balance or coordination; severe headache with no known cause; and confusion or disorientation. Immediate medical attention is crucial for stroke patients to receive appropriate treatment and prevent long-term complications.

A meta-analysis is a statistical method used to combine and summarize the results of multiple independent studies, with the aim of increasing statistical power, improving estimates of effect size, and identifying sources of heterogeneity. It involves systematically searching for and selecting relevant studies, assessing their quality and risk of bias, extracting and analyzing data using appropriate statistical models, and interpreting the findings in the context of the existing literature. Meta-analyses can provide more reliable evidence than individual studies, especially when the results are inconsistent or inconclusive, and can inform clinical guidelines, public health policies, and future research directions.

I'm happy to help! However, I must clarify that "information dissemination" is not a medical term per se, but rather a general term used in various fields, including healthcare and medicine. It refers to the process of spreading or distributing information to a specific audience or the public.

In the context of medicine and healthcare, information dissemination often relates to sharing clinical guidelines, research findings, public health messages, or patient education materials with healthcare professionals, patients, or the general public. This can occur through various channels, such as scientific conferences, peer-reviewed journals, newsletters, websites, social media platforms, and other communication methods.

The goal of information dissemination in medicine is to ensure that accurate, evidence-based, and up-to-date information reaches the intended audience, ultimately improving healthcare quality, patient outcomes, and decision-making processes.

"Patient dropouts" is a term used in clinical research and medical settings to refer to participants who withdraw or discontinue their participation in a treatment plan, clinical trial, or study before its completion. The reasons for patient dropouts can vary widely and may include factors such as adverse effects of the treatment, lack of efficacy, financial constraints, relocation, loss of interest, or personal reasons. High patient dropout rates can impact the validity and generalizability of research findings, making it challenging to assess the long-term safety and effectiveness of a particular intervention or treatment. Therefore, understanding and addressing the factors that contribute to patient dropouts is an important consideration in clinical research and practice.

A research subject, also commonly referred to as a "human subject" or "participant," is an individual who takes part in a research study or clinical trial. Research subjects are essential for the advancement of medical and scientific knowledge, as they provide data that can help researchers understand various phenomena, develop new treatments, and improve existing ones.

The term "research subject" emphasizes the ethical considerations involved in conducting research with human participants. It highlights the importance of protecting their rights, dignity, and well-being throughout the study. Researchers must obtain informed consent from subjects before enrolling them in a study, ensuring that they understand the purpose, procedures, potential risks, and benefits associated with the research.

Additionally, researchers are required to follow strict guidelines and regulations to minimize any harm or discomfort to the research subjects during the study. These guidelines may include requirements for data confidentiality, privacy protection, and monitoring of adverse events. Overall, treating research subjects with respect and care is crucial in maintaining the integrity of medical research and ensuring its societal benefits.

A questionnaire in the medical context is a standardized, systematic, and structured tool used to gather information from individuals regarding their symptoms, medical history, lifestyle, or other health-related factors. It typically consists of a series of written questions that can be either self-administered or administered by an interviewer. Questionnaires are widely used in various areas of healthcare, including clinical research, epidemiological studies, patient care, and health services evaluation to collect data that can inform diagnosis, treatment planning, and population health management. They provide a consistent and organized method for obtaining information from large groups or individual patients, helping to ensure accurate and comprehensive data collection while minimizing bias and variability in the information gathered.

Health care costs refer to the expenses incurred for medical services, treatments, procedures, and products that are used to maintain or restore an individual's health. These costs can be categorized into several types:

1. Direct costs: These include payments made for doctor visits, hospital stays, medications, diagnostic tests, surgeries, and other medical treatments and services. Direct costs can be further divided into two subcategories:
* Out-of-pocket costs: Expenses paid directly by patients, such as co-payments, deductibles, coinsurance, and any uncovered medical services or products.
* Third-party payer costs: Expenses covered by insurance companies, government programs (like Medicare, Medicaid), or other entities that pay for health care services on behalf of patients.
2. Indirect costs: These are the expenses incurred as a result of illness or injury that indirectly impact an individual's ability to work and earn a living. Examples include lost productivity, absenteeism, reduced earning capacity, and disability benefits.
3. Non-medical costs: These are expenses related to caregiving, transportation, home modifications, assistive devices, and other non-medical services required for managing health conditions or disabilities.

Health care costs can vary significantly depending on factors such as the type of medical service, geographic location, insurance coverage, and individual health status. Understanding these costs is essential for patients, healthcare providers, policymakers, and researchers to make informed decisions about treatment options, resource allocation, and health system design.

Data collection in the medical context refers to the systematic gathering of information relevant to a specific research question or clinical situation. This process involves identifying and recording data elements, such as demographic characteristics, medical history, physical examination findings, laboratory results, and imaging studies, from various sources including patient interviews, medical records, and diagnostic tests. The data collected is used to support clinical decision-making, inform research hypotheses, and evaluate the effectiveness of treatments or interventions. It is essential that data collection is performed in a standardized and unbiased manner to ensure the validity and reliability of the results.

Human experimentation is a branch of medical research that involves conducting experiments on human subjects. According to the World Medical Association's Declaration of Helsinki, which sets ethical standards for medical research involving human subjects, human experimentation is defined as "systematic study designed to develop or contribute to generalizable knowledge."

Human experimentation can take many forms, including clinical trials of new drugs or medical devices, observational studies, and interventional studies. In all cases, the principles of informed consent, risk minimization, and respect for the autonomy and dignity of the research subjects must be strictly adhered to.

Human experimentation has a controversial history, with many instances of unethical practices and abuse, such as the notorious Tuskegee syphilis study in which African American men were deliberately left untreated for syphilis without their informed consent. As a result, there are strict regulations and guidelines governing human experimentation to ensure that it is conducted ethically and with the utmost respect for the rights and welfare of research subjects.

Phase IV clinical trials, also known as post-marketing surveillance trials or post-authorization studies, are research studies conducted after a drug or medical device has been approved for marketing and made available to the public. The primary objective of these trials is to gather additional information about the safety, efficacy, and optimal use of the product in larger and more diverse populations over a longer period of time than was possible during the initial phases of clinical development (Phases I-III).

Phase IV studies can be designed to:

1. Evaluate long-term safety and side effects: These trials monitor adverse events that may not have been detected in earlier, shorter-term studies, allowing researchers to identify rare or delayed reactions and assess the overall risk-benefit profile of the product in real-world settings.
2. Assess effectiveness in various patient populations: Phase IV trials can help determine how well a treatment works in specific groups, such as children, elderly individuals, or those with multiple medical conditions or taking other medications concurrently. This information can inform labeling changes and guide clinical decision-making.
3. Compare the product to alternative treatments: Head-to-head comparisons of different drugs or devices can help healthcare providers make evidence-based choices when selecting therapies for their patients.
4. Investigate new indications or uses: Phase IV trials may explore whether a drug or device is effective for treating additional conditions or in different dosages, formulations, or routes of administration.
5. Evaluate cost-effectiveness and value: These studies can help healthcare systems and payers understand the economic impact of a product, including its costs relative to its benefits and potential savings from improved health outcomes or reduced complications.

Phase IV clinical trials are essential for ensuring that new treatments continue to demonstrate safety and efficacy as they are used more widely in larger and more diverse populations. This information can lead to updates in labeling, guidelines, and prescribing practices, ultimately improving patient care and outcomes.

I'm sorry for any confusion, but the term "Great Britain" is not a medical concept or condition. It is a geographical and political term referring to the largest island in the British Isles, on which the majority of England, Scotland, and Wales are located. It's also used to refer to the political union of these three countries, which is called the United Kingdom. Therefore, it doesn't have a medical definition.

I'm sorry for any confusion, but the term "Europe" is a geographical and political designation, rather than a medical one. It refers to the continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, and the Mediterranean Sea to the south. Europe is made up of approximately 50 countries, depending on how one defines a "country."

If you have any questions related to medical terminology or health-related topics, I'd be happy to help answer them!

Decision support techniques are methods used to help individuals or groups make informed and effective decisions in a medical context. These techniques can involve various approaches, such as:

1. **Clinical Decision Support Systems (CDSS):** Computerized systems that provide clinicians with patient-specific information and evidence-based recommendations to assist in decision-making. CDSS can be integrated into electronic health records (EHRs) or standalone applications.

2. **Evidence-Based Medicine (EBM):** A systematic approach to clinical decision-making that involves the integration of best available research evidence, clinician expertise, and patient values and preferences. EBM emphasizes the importance of using high-quality scientific studies to inform medical decisions.

3. **Diagnostic Reasoning:** The process of formulating a diagnosis based on history, physical examination, and diagnostic tests. Diagnostic reasoning techniques may include pattern recognition, hypothetico-deductive reasoning, or a combination of both.

4. **Predictive Modeling:** The use of statistical models to predict patient outcomes based on historical data and clinical variables. These models can help clinicians identify high-risk patients and inform treatment decisions.

5. **Cost-Effectiveness Analysis (CEA):** An economic evaluation technique that compares the costs and benefits of different medical interventions to determine which option provides the most value for money. CEA can assist decision-makers in allocating resources efficiently.

6. **Multicriteria Decision Analysis (MCDA):** A structured approach to decision-making that involves identifying, evaluating, and comparing multiple criteria or objectives. MCDA can help clinicians and patients make complex decisions by accounting for various factors, such as efficacy, safety, cost, and patient preferences.

7. **Shared Decision-Making (SDM):** A collaborative approach to decision-making that involves the clinician and patient working together to choose the best course of action based on the available evidence, clinical expertise, and patient values and preferences. SDM aims to empower patients to participate actively in their care.

These techniques can be used individually or in combination to support medical decision-making and improve patient outcomes.

A single-blind method in medical research is a study design where the participants are unaware of the group or intervention they have been assigned to, but the researchers conducting the study know which participant belongs to which group. This is done to prevent bias from the participants' expectations or knowledge of their assignment, while still allowing the researchers to control the study conditions and collect data.

In a single-blind trial, the participants do not know whether they are receiving the active treatment or a placebo (a sham treatment that looks like the real thing but has no therapeutic effect), whereas the researcher knows which participant is receiving which intervention. This design helps to ensure that the participants' responses and outcomes are not influenced by their knowledge of the treatment assignment, while still allowing the researchers to assess the effectiveness or safety of the intervention being studied.

Single-blind methods are commonly used in clinical trials and other medical research studies where it is important to minimize bias and control for confounding variables that could affect the study results.

Breast neoplasms refer to abnormal growths in the breast tissue that can be benign or malignant. Benign breast neoplasms are non-cancerous tumors or growths, while malignant breast neoplasms are cancerous tumors that can invade surrounding tissues and spread to other parts of the body.

Breast neoplasms can arise from different types of cells in the breast, including milk ducts, milk sacs (lobules), or connective tissue. The most common type of breast cancer is ductal carcinoma, which starts in the milk ducts and can spread to other parts of the breast and nearby structures.

Breast neoplasms are usually detected through screening methods such as mammography, ultrasound, or MRI, or through self-examination or clinical examination. Treatment options for breast neoplasms depend on several factors, including the type and stage of the tumor, the patient's age and overall health, and personal preferences. Treatment may include surgery, radiation therapy, chemotherapy, hormone therapy, or targeted therapy.

Antineoplastic combined chemotherapy protocols refer to a treatment plan for cancer that involves the use of more than one antineoplastic (chemotherapy) drug given in a specific sequence and schedule. The combination of drugs is used because they may work better together to destroy cancer cells compared to using a single agent alone. This approach can also help to reduce the likelihood of cancer cells becoming resistant to the treatment.

The choice of drugs, dose, duration, and frequency are determined by various factors such as the type and stage of cancer, patient's overall health, and potential side effects. Combination chemotherapy protocols can be used in various settings, including as a primary treatment, adjuvant therapy (given after surgery or radiation to kill any remaining cancer cells), neoadjuvant therapy (given before surgery or radiation to shrink the tumor), or palliative care (to alleviate symptoms and prolong survival).

It is important to note that while combined chemotherapy protocols can be effective in treating certain types of cancer, they can also cause significant side effects, including nausea, vomiting, hair loss, fatigue, and an increased risk of infection. Therefore, patients undergoing such treatment should be closely monitored and managed by a healthcare team experienced in administering chemotherapy.

Prognosis is a medical term that refers to the prediction of the likely outcome or course of a disease, including the chances of recovery or recurrence, based on the patient's symptoms, medical history, physical examination, and diagnostic tests. It is an important aspect of clinical decision-making and patient communication, as it helps doctors and patients make informed decisions about treatment options, set realistic expectations, and plan for future care.

Prognosis can be expressed in various ways, such as percentages, categories (e.g., good, fair, poor), or survival rates, depending on the nature of the disease and the available evidence. However, it is important to note that prognosis is not an exact science and may vary depending on individual factors, such as age, overall health status, and response to treatment. Therefore, it should be used as a guide rather than a definitive forecast.

Retrospective studies, also known as retrospective research or looking back studies, are a type of observational study that examines data from the past to draw conclusions about possible causal relationships between risk factors and outcomes. In these studies, researchers analyze existing records, medical charts, or previously collected data to test a hypothesis or answer a specific research question.

Retrospective studies can be useful for generating hypotheses and identifying trends, but they have limitations compared to prospective studies, which follow participants forward in time from exposure to outcome. Retrospective studies are subject to biases such as recall bias, selection bias, and information bias, which can affect the validity of the results. Therefore, retrospective studies should be interpreted with caution and used primarily to generate hypotheses for further testing in prospective studies.

A dose-response relationship in the context of drugs refers to the changes in the effects or symptoms that occur as the dose of a drug is increased or decreased. Generally, as the dose of a drug is increased, the severity or intensity of its effects also increases. Conversely, as the dose is decreased, the effects of the drug become less severe or may disappear altogether.

The dose-response relationship is an important concept in pharmacology and toxicology because it helps to establish the safe and effective dosage range for a drug. By understanding how changes in the dose of a drug affect its therapeutic and adverse effects, healthcare providers can optimize treatment plans for their patients while minimizing the risk of harm.

The dose-response relationship is typically depicted as a curve that shows the relationship between the dose of a drug and its effect. The shape of the curve may vary depending on the drug and the specific effect being measured. Some drugs may have a steep dose-response curve, meaning that small changes in the dose can result in large differences in the effect. Other drugs may have a more gradual dose-response curve, where larger changes in the dose are needed to produce significant effects.

In addition to helping establish safe and effective dosages, the dose-response relationship is also used to evaluate the potential therapeutic benefits and risks of new drugs during clinical trials. By systematically testing different doses of a drug in controlled studies, researchers can identify the optimal dosage range for the drug and assess its safety and efficacy.

Biomedical research is a branch of scientific research that involves the study of biological processes and diseases in order to develop new treatments and therapies. This type of research often involves the use of laboratory techniques, such as cell culture and genetic engineering, as well as clinical trials in humans. The goal of biomedical research is to advance our understanding of how living organisms function and to find ways to prevent and treat various medical conditions. It encompasses a wide range of disciplines, including molecular biology, genetics, immunology, pharmacology, and neuroscience, among others. Ultimately, the aim of biomedical research is to improve human health and well-being.

Recurrence, in a medical context, refers to the return of symptoms or signs of a disease after a period of improvement or remission. It indicates that the condition has not been fully eradicated and may require further treatment. Recurrence is often used to describe situations where a disease such as cancer comes back after initial treatment, but it can also apply to other medical conditions. The likelihood of recurrence varies depending on the type of disease and individual patient factors.

Monoclonal antibodies are laboratory-produced proteins that mimic the immune system's ability to fight off harmful antigens such as viruses and cancer cells. They are created by fusing a single B cell (the type of white blood cell responsible for producing antibodies) with a tumor cell, resulting in a hybrid cell called a hybridoma. This hybridoma can then be cloned to produce a large number of identical cells, all producing the same antibody, hence "monoclonal."

Humanized monoclonal antibodies are a type of monoclonal antibody that have been genetically engineered to include human components. This is done to reduce the risk of an adverse immune response in patients receiving the treatment. In this process, the variable region of the mouse monoclonal antibody, which contains the antigen-binding site, is grafted onto a human constant region. The resulting humanized monoclonal antibody retains the ability to bind to the target antigen while minimizing the immunogenicity associated with murine (mouse) antibodies.

In summary, "antibodies, monoclonal, humanized" refers to a type of laboratory-produced protein that mimics the immune system's ability to fight off harmful antigens, but with reduced immunogenicity due to the inclusion of human components in their structure.

Research ethics refers to the principles and guidelines that govern the conduct of research involving human participants or animals. The overarching goal of research ethics is to ensure that research is conducted in a way that respects the autonomy, dignity, and well-being of all those involved. Research ethics are designed to prevent harm, promote fairness, and maintain trust between researchers and study participants.

Some key principles of research ethics include:

1. Respect for Persons: This means treating all individuals with respect and dignity, and recognizing their autonomy and right to make informed decisions about participating in research.
2. Beneficence: Researchers have a duty to maximize the benefits of research while minimizing potential harms.
3. Justice: Research should be conducted fairly, without discrimination or bias, and should benefit all those who are affected by it.
4. Confidentiality: Researchers must protect the privacy and confidentiality of study participants, including their personal information and data.
5. Informed Consent: Participants must give their voluntary and informed consent to participate in research, after being fully informed about the nature of the study, its risks and benefits, and their rights as a participant.

Research ethics are typically overseen by institutional review boards (IRBs) or research ethics committees (RECs), which review research proposals and monitor ongoing studies to ensure that they comply with ethical guidelines. Researchers who violate these guidelines may face sanctions, including loss of funding, suspension or revocation of their research privileges, or legal action.

Informed consent is a process in medical care where patients are provided with all relevant information about their health status, proposed treatments, potential risks and benefits, and alternative options. This allows patients to make informed decisions regarding their healthcare and understand the consequences of their choices. The process includes ensuring that the patient has adequate mental capacity to make such decisions, is fully aware of the implications, and gives their voluntary agreement for the proposed treatment or procedure. It's a fundamental principle in medical ethics and is required by law in many jurisdictions to protect patients' rights.

Early termination of clinical trials refers to the discontinuation of a medical research study before its planned end date. This can occur for several reasons, including:

1. Safety concerns: If the experimental treatment is found to be harmful or poses significant risks to the participants, the trial may be stopped early to protect their well-being.
2. Efficacy demonstrated: If the experimental treatment shows promising results and is significantly better than the current standard of care, an independent data monitoring committee may recommend stopping the trial early so that the treatment can be made available to all patients as soon as possible.
3. Futility: If it becomes clear that the experimental treatment is unlikely to provide any meaningful benefit compared to the current standard of care, the trial may be stopped early to avoid exposing more participants to unnecessary risks and to allocate resources more efficiently.
4. Insufficient recruitment or funding: If there are not enough participants enrolled in the study or if funding for the trial is withdrawn, it may need to be terminated prematurely.
5. Violation of ethical guidelines or regulations: If the trial is found to be non-compliant with regulatory requirements or ethical standards, it may be stopped early by the sponsor, investigator, or regulatory authorities.

When a clinical trial is terminated early, the data collected up until that point are still analyzed and reported, but the results should be interpreted with caution due to the limited sample size and potential biases introduced by the early termination.

'Guidelines' in the medical context are systematically developed statements or sets of recommendations designed to assist healthcare professionals and patients in making informed decisions about appropriate health care for specific clinical circumstances. They are based on a thorough evaluation of the available evidence, including scientific studies, expert opinions, and patient values. Guidelines may cover a wide range of topics, such as diagnosis, treatment, prevention, screening, and management of various diseases and conditions. They aim to standardize care, improve patient outcomes, reduce unnecessary variations in practice, and promote efficient use of healthcare resources.

Disease progression is the worsening or advancement of a medical condition over time. It refers to the natural course of a disease, including its development, the severity of symptoms and complications, and the impact on the patient's overall health and quality of life. Understanding disease progression is important for developing appropriate treatment plans, monitoring response to therapy, and predicting outcomes.

The rate of disease progression can vary widely depending on the type of medical condition, individual patient factors, and the effectiveness of treatment. Some diseases may progress rapidly over a short period of time, while others may progress more slowly over many years. In some cases, disease progression may be slowed or even halted with appropriate medical interventions, while in other cases, the progression may be inevitable and irreversible.

In clinical practice, healthcare providers closely monitor disease progression through regular assessments, imaging studies, and laboratory tests. This information is used to guide treatment decisions and adjust care plans as needed to optimize patient outcomes and improve quality of life.

Antirheumatic agents are a class of drugs used to treat rheumatoid arthritis, other inflammatory types of arthritis, and related conditions. These medications work by reducing inflammation in the body, relieving symptoms such as pain, swelling, and stiffness in the joints. They can also help slow down or prevent joint damage and disability caused by the disease.

There are several types of antirheumatic agents, including:

1. Nonsteroidal anti-inflammatory drugs (NSAIDs): These medications, such as ibuprofen and naproxen, reduce inflammation and relieve pain. They are often used to treat mild to moderate symptoms of arthritis.
2. Corticosteroids: These powerful anti-inflammatory drugs, such as prednisone and cortisone, can quickly reduce inflammation and suppress the immune system. They are usually used for short-term relief of severe symptoms or in combination with other antirheumatic agents.
3. Disease-modifying antirheumatic drugs (DMARDs): These medications, such as methotrexate and hydroxychloroquine, work by slowing down the progression of rheumatoid arthritis and preventing joint damage. They can take several weeks or months to become fully effective.
4. Biologic response modifiers (biologics): These are a newer class of DMARDs that target specific molecules involved in the immune response. They include drugs such as adalimumab, etanercept, and infliximab. Biologics are usually used in combination with other antirheumatic agents for patients who have not responded to traditional DMARD therapy.
5. Janus kinase (JAK) inhibitors: These medications, such as tofacitinib and baricitinib, work by blocking the action of enzymes called JAKs that are involved in the immune response. They are used to treat moderate to severe rheumatoid arthritis and can be used in combination with other antirheumatic agents.

It is important to note that antirheumatic agents can have significant side effects and should only be prescribed by a healthcare provider who is experienced in the management of rheumatoid arthritis. Regular monitoring and follow-up are essential to ensure safe and effective treatment.

Cardiovascular diseases (CVDs) are a class of diseases that affect the heart and blood vessels. They are the leading cause of death globally, according to the World Health Organization (WHO). The term "cardiovascular disease" refers to a group of conditions that include:

1. Coronary artery disease (CAD): This is the most common type of heart disease and occurs when the arteries that supply blood to the heart become narrowed or blocked due to the buildup of cholesterol, fat, and other substances in the walls of the arteries. This can lead to chest pain, shortness of breath, or a heart attack.
2. Heart failure: This occurs when the heart is unable to pump blood efficiently to meet the body's needs. It can be caused by various conditions, including coronary artery disease, high blood pressure, and cardiomyopathy.
3. Stroke: A stroke occurs when the blood supply to a part of the brain is interrupted or reduced, often due to a clot or a ruptured blood vessel. This can cause brain damage or death.
4. Peripheral artery disease (PAD): This occurs when the arteries that supply blood to the limbs become narrowed or blocked, leading to pain, numbness, or weakness in the legs or arms.
5. Rheumatic heart disease: This is a complication of untreated strep throat and can cause damage to the heart valves, leading to heart failure or other complications.
6. Congenital heart defects: These are structural problems with the heart that are present at birth. They can range from mild to severe and may require medical intervention.
7. Cardiomyopathy: This is a disease of the heart muscle that makes it harder for the heart to pump blood efficiently. It can be caused by various factors, including genetics, infections, and certain medications.
8. Heart arrhythmias: These are abnormal heart rhythms that can cause the heart to beat too fast, too slow, or irregularly. They can lead to symptoms such as palpitations, dizziness, or fainting.
9. Valvular heart disease: This occurs when one or more of the heart valves become damaged or diseased, leading to problems with blood flow through the heart.
10. Aortic aneurysm and dissection: These are conditions that affect the aorta, the largest artery in the body. An aneurysm is a bulge in the aorta, while a dissection is a tear in the inner layer of the aorta. Both can be life-threatening if not treated promptly.

It's important to note that many of these conditions can be managed or treated with medical interventions such as medications, surgery, or lifestyle changes. If you have any concerns about your heart health, it's important to speak with a healthcare provider.

Statistical models are mathematical representations that describe the relationship between variables in a given dataset. They are used to analyze and interpret data in order to make predictions or test hypotheses about a population. In the context of medicine, statistical models can be used for various purposes such as:

1. Disease risk prediction: By analyzing demographic, clinical, and genetic data using statistical models, researchers can identify factors that contribute to an individual's risk of developing certain diseases. This information can then be used to develop personalized prevention strategies or early detection methods.

2. Clinical trial design and analysis: Statistical models are essential tools for designing and analyzing clinical trials. They help determine sample size, allocate participants to treatment groups, and assess the effectiveness and safety of interventions.

3. Epidemiological studies: Researchers use statistical models to investigate the distribution and determinants of health-related events in populations. This includes studying patterns of disease transmission, evaluating public health interventions, and estimating the burden of diseases.

4. Health services research: Statistical models are employed to analyze healthcare utilization, costs, and outcomes. This helps inform decisions about resource allocation, policy development, and quality improvement initiatives.

5. Biostatistics and bioinformatics: In these fields, statistical models are used to analyze large-scale molecular data (e.g., genomics, proteomics) to understand biological processes and identify potential therapeutic targets.

In summary, statistical models in medicine provide a framework for understanding complex relationships between variables and making informed decisions based on data-driven insights.

Adjuvant chemotherapy is a medical treatment that is given in addition to the primary therapy, such as surgery or radiation, to increase the chances of a cure or to reduce the risk of recurrence in patients with cancer. It involves the use of chemicals (chemotherapeutic agents) to destroy any remaining cancer cells that may not have been removed by the primary treatment. This type of chemotherapy is typically given after the main treatment has been completed, and its goal is to kill any residual cancer cells that may be present in the body and reduce the risk of the cancer coming back. The specific drugs used and the duration of treatment will depend on the type and stage of cancer being treated.

Medical ethics is a branch of ethics that deals with moral issues in medical care, research, and practice. It provides a framework for addressing questions related to patient autonomy, informed consent, confidentiality, distributive justice, beneficentia (doing good), and non-maleficence (not doing harm). Medical ethics also involves the application of ethical principles such as respect for persons, beneficence, non-maleficence, and justice to specific medical cases and situations. It is a crucial component of medical education and practice, helping healthcare professionals make informed decisions that promote patient well-being while respecting their rights and dignity.

An acute disease is a medical condition that has a rapid onset, develops quickly, and tends to be short in duration. Acute diseases can range from minor illnesses such as a common cold or flu, to more severe conditions such as pneumonia, meningitis, or a heart attack. These types of diseases often have clear symptoms that are easy to identify, and they may require immediate medical attention or treatment.

Acute diseases are typically caused by an external agent or factor, such as a bacterial or viral infection, a toxin, or an injury. They can also be the result of a sudden worsening of an existing chronic condition. In general, acute diseases are distinct from chronic diseases, which are long-term medical conditions that develop slowly over time and may require ongoing management and treatment.

Examples of acute diseases include:

* Acute bronchitis: a sudden inflammation of the airways in the lungs, often caused by a viral infection.
* Appendicitis: an inflammation of the appendix that can cause severe pain and requires surgical removal.
* Gastroenteritis: an inflammation of the stomach and intestines, often caused by a viral or bacterial infection.
* Migraine headaches: intense headaches that can last for hours or days, and are often accompanied by nausea, vomiting, and sensitivity to light and sound.
* Myocardial infarction (heart attack): a sudden blockage of blood flow to the heart muscle, often caused by a buildup of plaque in the coronary arteries.
* Pneumonia: an infection of the lungs that can cause coughing, chest pain, and difficulty breathing.
* Sinusitis: an inflammation of the sinuses, often caused by a viral or bacterial infection.

It's important to note that while some acute diseases may resolve on their own with rest and supportive care, others may require medical intervention or treatment to prevent complications and promote recovery. If you are experiencing symptoms of an acute disease, it is always best to seek medical attention to ensure proper diagnosis and treatment.

HIV (Human Immunodeficiency Virus) infection is a viral illness that progressively attacks and weakens the immune system, making individuals more susceptible to other infections and diseases. The virus primarily infects CD4+ T cells, a type of white blood cell essential for fighting off infections. Over time, as the number of these immune cells declines, the body becomes increasingly vulnerable to opportunistic infections and cancers.

HIV infection has three stages:

1. Acute HIV infection: This is the initial stage that occurs within 2-4 weeks after exposure to the virus. During this period, individuals may experience flu-like symptoms such as fever, fatigue, rash, swollen glands, and muscle aches. The virus replicates rapidly, and the viral load in the body is very high.
2. Chronic HIV infection (Clinical latency): This stage follows the acute infection and can last several years if left untreated. Although individuals may not show any symptoms during this phase, the virus continues to replicate at low levels, and the immune system gradually weakens. The viral load remains relatively stable, but the number of CD4+ T cells declines over time.
3. AIDS (Acquired Immunodeficiency Syndrome): This is the most advanced stage of HIV infection, characterized by a severely damaged immune system and numerous opportunistic infections or cancers. At this stage, the CD4+ T cell count drops below 200 cells/mm3 of blood.

It's important to note that with proper antiretroviral therapy (ART), individuals with HIV infection can effectively manage the virus, maintain a healthy immune system, and significantly reduce the risk of transmission to others. Early diagnosis and treatment are crucial for improving long-term health outcomes and reducing the spread of HIV.

In clinical research, sample size refers to the number of participants or observations included in a study. It is a critical aspect of study design that can impact the validity and generalizability of research findings. A larger sample size typically provides more statistical power, which means that it is more likely to detect true effects if they exist. However, increasing the sample size also increases the cost and time required for a study. Therefore, determining an appropriate sample size involves balancing statistical power with practical considerations.

The calculation of sample size depends on several factors, including the expected effect size, the variability of the outcome measure, the desired level of statistical significance, and the desired power of the study. Statistical software programs are often used to calculate sample sizes that balance these factors while minimizing the overall sample size required to detect a meaningful effect.

It is important to note that a larger sample size does not necessarily mean that a study is more rigorous or well-designed. The quality of the study's methods, including the selection of participants, the measurement of outcomes, and the analysis of data, are also critical factors that can impact the validity and generalizability of research findings.

Platelet aggregation inhibitors are a class of medications that prevent platelets (small blood cells involved in clotting) from sticking together and forming a clot. These drugs work by interfering with the ability of platelets to adhere to each other and to the damaged vessel wall, thereby reducing the risk of thrombosis (blood clot formation).

Platelet aggregation inhibitors are often prescribed for people who have an increased risk of developing blood clots due to various medical conditions such as atrial fibrillation, coronary artery disease, peripheral artery disease, stroke, or a history of heart attack. They may also be used in patients undergoing certain medical procedures, such as angioplasty and stenting, to prevent blood clot formation in the stents.

Examples of platelet aggregation inhibitors include:

1. Aspirin: A nonsteroidal anti-inflammatory drug (NSAID) that irreversibly inhibits the enzyme cyclooxygenase, which is involved in platelet activation and aggregation.
2. Clopidogrel (Plavix): A P2Y12 receptor antagonist that selectively blocks ADP-induced platelet activation and aggregation.
3. Prasugrel (Effient): A third-generation thienopyridine P2Y12 receptor antagonist, similar to clopidogrel but with faster onset and greater potency.
4. Ticagrelor (Brilinta): A direct-acting P2Y12 receptor antagonist that does not require metabolic activation and has a reversible binding profile.
5. Dipyridamole (Persantine): An antiplatelet agent that inhibits platelet aggregation by increasing cyclic adenosine monophosphate (cAMP) levels in platelets, which leads to decreased platelet reactivity.
6. Iloprost (Ventavis): A prostacyclin analogue that inhibits platelet aggregation and causes vasodilation, often used in the treatment of pulmonary arterial hypertension.
7. Cilostazol (Pletal): A phosphodiesterase III inhibitor that increases cAMP levels in platelets, leading to decreased platelet activation and aggregation, as well as vasodilation.
8. Ticlopidine (Ticlid): An older P2Y12 receptor antagonist with a slower onset of action and more frequent side effects compared to clopidogrel or prasugrel.

An ethics consultation is a process in which healthcare professionals seek guidance and advice on ethical issues related to patient care from an expert panel or individual with specialized knowledge and training in medical ethics. The consultation may be requested by any member of the healthcare team, as well as patients and their families, when there are concerns about moral values, principles, and duties that arise during clinical decision-making.

The primary goal of an ethics consultation is to identify and analyze ethical dilemmas, clarify relevant ethical considerations, and provide recommendations for a course of action that respects the autonomy, beneficence, nonmaleficence, and justice for all parties involved. The process typically involves gathering information about the case, identifying key ethical issues, consulting with relevant stakeholders, and formulating a plan to address the concerns raised.

Ethics consultations can be helpful in situations where there is disagreement among healthcare providers or between patients and their caregivers regarding treatment options, goals of care, end-of-life decisions, informed consent, confidentiality, resource allocation, and other ethical challenges that arise in clinical practice. The recommendations provided by an ethics consultation are advisory in nature and do not replace the legal or professional responsibilities of healthcare providers.

I'm sorry for any confusion, but "pilot projects" is not a medical term per se. Instead, it is a general term used in various fields, including healthcare and medicine, to describe a small-scale initiative that is implemented on a temporary basis to evaluate its feasibility, effectiveness, or impact before deciding whether to expand or continue it.

In the context of healthcare, pilot projects might involve testing new treatment protocols, implementing innovative care models, or introducing technology solutions in a limited setting to assess their potential benefits and drawbacks. The results of these projects can help inform decisions about broader implementation and provide valuable insights for improving the quality and efficiency of healthcare services.

Fibrinolytic agents are medications that dissolve or break down blood clots by activating plasminogen, which is converted into plasmin. Plasmin is a proteolytic enzyme that degrades fibrin, the structural protein in blood clots. Fibrinolytic agents are used medically to treat conditions such as acute ischemic stroke, deep vein thrombosis, pulmonary embolism, and myocardial infarction (heart attack) by restoring blood flow in occluded vessels. Examples of fibrinolytic agents include alteplase, reteplase, and tenecteplase. It is important to note that these medications carry a risk of bleeding complications and should be administered with caution.

Anti-bacterial agents, also known as antibiotics, are a type of medication used to treat infections caused by bacteria. These agents work by either killing the bacteria or inhibiting their growth and reproduction. There are several different classes of anti-bacterial agents, including penicillins, cephalosporins, fluoroquinolones, macrolides, and tetracyclines, among others. Each class of antibiotic has a specific mechanism of action and is used to treat certain types of bacterial infections. It's important to note that anti-bacterial agents are not effective against viral infections, such as the common cold or flu. Misuse and overuse of antibiotics can lead to antibiotic resistance, which is a significant global health concern.

Therapeutic human experimentation, also known as clinical research or clinical trials, is a branch of medical research that involves the testing of new medical treatments, drugs, devices, or procedures on human subjects. The goal of this type of research is to evaluate the safety and efficacy of these interventions in order to determine whether they should be approved for use in clinical practice.

The term "therapeutic" is used to distinguish this type of research from non-therapeutic research, which does not involve direct medical benefit to the participant. In therapeutic human experimentation, participants may receive some potential direct medical benefit from their participation, although they may also experience risks or side effects.

Therapeutic human experimentation is subject to strict ethical guidelines and regulations, including informed consent, risk-benefit analysis, and independent review by ethics committees or institutional review boards (IRBs). These safeguards are designed to protect the rights and welfare of research participants and ensure that the research is conducted in a responsible and transparent manner.

"Age factors" refer to the effects, changes, or differences that age can have on various aspects of health, disease, and medical care. These factors can encompass a wide range of issues, including:

1. Physiological changes: As people age, their bodies undergo numerous physical changes that can affect how they respond to medications, illnesses, and medical procedures. For example, older adults may be more sensitive to certain drugs or have weaker immune systems, making them more susceptible to infections.
2. Chronic conditions: Age is a significant risk factor for many chronic diseases, such as heart disease, diabetes, cancer, and arthritis. As a result, age-related medical issues are common and can impact treatment decisions and outcomes.
3. Cognitive decline: Aging can also lead to cognitive changes, including memory loss and decreased decision-making abilities. These changes can affect a person's ability to understand and comply with medical instructions, leading to potential complications in their care.
4. Functional limitations: Older adults may experience physical limitations that impact their mobility, strength, and balance, increasing the risk of falls and other injuries. These limitations can also make it more challenging for them to perform daily activities, such as bathing, dressing, or cooking.
5. Social determinants: Age-related factors, such as social isolation, poverty, and lack of access to transportation, can impact a person's ability to obtain necessary medical care and affect their overall health outcomes.

Understanding age factors is critical for healthcare providers to deliver high-quality, patient-centered care that addresses the unique needs and challenges of older adults. By taking these factors into account, healthcare providers can develop personalized treatment plans that consider a person's age, physical condition, cognitive abilities, and social circumstances.

Monoclonal antibodies are a type of antibody that are identical because they are produced by a single clone of cells. They are laboratory-produced molecules that act like human antibodies in the immune system. They can be designed to attach to specific proteins found on the surface of cancer cells, making them useful for targeting and treating cancer. Monoclonal antibodies can also be used as a therapy for other diseases, such as autoimmune disorders and inflammatory conditions.

Monoclonal antibodies are produced by fusing a single type of immune cell, called a B cell, with a tumor cell to create a hybrid cell, or hybridoma. This hybrid cell is then able to replicate indefinitely, producing a large number of identical copies of the original antibody. These antibodies can be further modified and engineered to enhance their ability to bind to specific targets, increase their stability, and improve their effectiveness as therapeutic agents.

Monoclonal antibodies have several mechanisms of action in cancer therapy. They can directly kill cancer cells by binding to them and triggering an immune response. They can also block the signals that promote cancer growth and survival. Additionally, monoclonal antibodies can be used to deliver drugs or radiation directly to cancer cells, increasing the effectiveness of these treatments while minimizing their side effects on healthy tissues.

Monoclonal antibodies have become an important tool in modern medicine, with several approved for use in cancer therapy and other diseases. They are continuing to be studied and developed as a promising approach to treating a wide range of medical conditions.

A factual database in the medical context is a collection of organized and structured data that contains verified and accurate information related to medicine, healthcare, or health sciences. These databases serve as reliable resources for various stakeholders, including healthcare professionals, researchers, students, and patients, to access evidence-based information for making informed decisions and enhancing knowledge.

Examples of factual medical databases include:

1. PubMed: A comprehensive database of biomedical literature maintained by the US National Library of Medicine (NLM). It contains citations and abstracts from life sciences journals, books, and conference proceedings.
2. MEDLINE: A subset of PubMed, MEDLINE focuses on high-quality, peer-reviewed articles related to biomedicine and health. It is the primary component of the NLM's database and serves as a critical resource for healthcare professionals and researchers worldwide.
3. Cochrane Library: A collection of systematic reviews and meta-analyses focused on evidence-based medicine. The library aims to provide unbiased, high-quality information to support clinical decision-making and improve patient outcomes.
4. OVID: A platform that offers access to various medical and healthcare databases, including MEDLINE, Embase, and PsycINFO. It facilitates the search and retrieval of relevant literature for researchers, clinicians, and students.
5. ClinicalTrials.gov: A registry and results database of publicly and privately supported clinical studies conducted around the world. The platform aims to increase transparency and accessibility of clinical trial data for healthcare professionals, researchers, and patients.
6. UpToDate: An evidence-based, physician-authored clinical decision support resource that provides information on diagnosis, treatment, and prevention of medical conditions. It serves as a point-of-care tool for healthcare professionals to make informed decisions and improve patient care.
7. TRIP Database: A search engine designed to facilitate evidence-based medicine by providing quick access to high-quality resources, including systematic reviews, clinical guidelines, and practice recommendations.
8. National Guideline Clearinghouse (NGC): A database of evidence-based clinical practice guidelines and related documents developed through a rigorous review process. The NGC aims to provide clinicians, healthcare providers, and policymakers with reliable guidance for patient care.
9. DrugBank: A comprehensive, freely accessible online database containing detailed information about drugs, their mechanisms, interactions, and targets. It serves as a valuable resource for researchers, healthcare professionals, and students in the field of pharmacology and drug discovery.
10. Genetic Testing Registry (GTR): A database that provides centralized information about genetic tests, test developers, laboratories offering tests, and clinical validity and utility of genetic tests. It serves as a resource for healthcare professionals, researchers, and patients to make informed decisions regarding genetic testing.

Combined modality therapy (CMT) is a medical treatment approach that utilizes more than one method or type of therapy simultaneously or in close succession, with the goal of enhancing the overall effectiveness of the treatment. In the context of cancer care, CMT often refers to the combination of two or more primary treatment modalities, such as surgery, radiation therapy, and systemic therapies (chemotherapy, immunotherapy, targeted therapy, etc.).

The rationale behind using combined modality therapy is that each treatment method can target cancer cells in different ways, potentially increasing the likelihood of eliminating all cancer cells and reducing the risk of recurrence. The specific combination and sequence of treatments will depend on various factors, including the type and stage of cancer, patient's overall health, and individual preferences.

For example, a common CMT approach for locally advanced rectal cancer may involve preoperative (neoadjuvant) chemoradiation therapy, followed by surgery to remove the tumor, and then postoperative (adjuvant) chemotherapy. This combined approach allows for the reduction of the tumor size before surgery, increases the likelihood of complete tumor removal, and targets any remaining microscopic cancer cells with systemic chemotherapy.

It is essential to consult with a multidisciplinary team of healthcare professionals to determine the most appropriate CMT plan for each individual patient, considering both the potential benefits and risks associated with each treatment method.

Anticoagulants are a class of medications that work to prevent the formation of blood clots in the body. They do this by inhibiting the coagulation cascade, which is a series of chemical reactions that lead to the formation of a clot. Anticoagulants can be given orally, intravenously, or subcutaneously, depending on the specific drug and the individual patient's needs.

There are several different types of anticoagulants, including:

1. Heparin: This is a naturally occurring anticoagulant that is often used in hospitalized patients who require immediate anticoagulation. It works by activating an enzyme called antithrombin III, which inhibits the formation of clots.
2. Low molecular weight heparin (LMWH): LMWH is a form of heparin that has been broken down into smaller molecules. It has a longer half-life than standard heparin and can be given once or twice daily by subcutaneous injection.
3. Direct oral anticoagulants (DOACs): These are newer oral anticoagulants that work by directly inhibiting specific clotting factors in the coagulation cascade. Examples include apixaban, rivaroxaban, and dabigatran.
4. Vitamin K antagonists: These are older oral anticoagulants that work by inhibiting the action of vitamin K, which is necessary for the formation of clotting factors. Warfarin is an example of a vitamin K antagonist.

Anticoagulants are used to prevent and treat a variety of conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation, and prosthetic heart valve thrombosis. It is important to note that anticoagulants can increase the risk of bleeding, so they must be used with caution and regular monitoring of blood clotting times may be required.

Sensitivity and specificity are statistical measures used to describe the performance of a diagnostic test or screening tool in identifying true positive and true negative results.

* Sensitivity refers to the proportion of people who have a particular condition (true positives) who are correctly identified by the test. It is also known as the "true positive rate" or "recall." A highly sensitive test will identify most or all of the people with the condition, but may also produce more false positives.
* Specificity refers to the proportion of people who do not have a particular condition (true negatives) who are correctly identified by the test. It is also known as the "true negative rate." A highly specific test will identify most or all of the people without the condition, but may also produce more false negatives.

In medical testing, both sensitivity and specificity are important considerations when evaluating a diagnostic test. High sensitivity is desirable for screening tests that aim to identify as many cases of a condition as possible, while high specificity is desirable for confirmatory tests that aim to rule out the condition in people who do not have it.

It's worth noting that sensitivity and specificity are often influenced by factors such as the prevalence of the condition in the population being tested, the threshold used to define a positive result, and the reliability and validity of the test itself. Therefore, it's important to consider these factors when interpreting the results of a diagnostic test.

Antihypertensive agents are a class of medications used to treat high blood pressure (hypertension). They work by reducing the force and rate of heart contractions, dilating blood vessels, or altering neurohormonal activation to lower blood pressure. Examples include diuretics, beta blockers, ACE inhibitors, ARBs, calcium channel blockers, and direct vasodilators. These medications may be used alone or in combination to achieve optimal blood pressure control.

In epidemiology, the incidence of a disease is defined as the number of new cases of that disease within a specific population over a certain period of time. It is typically expressed as a rate, with the number of new cases in the numerator and the size of the population at risk in the denominator. Incidence provides information about the risk of developing a disease during a given time period and can be used to compare disease rates between different populations or to monitor trends in disease occurrence over time.

Medical oncology is a branch of medicine that deals with the prevention, diagnosis, and treatment of cancer using systemic medications, including chemotherapy, hormonal therapy, targeted therapy, and immunotherapy. Medical oncologists are specialized physicians who manage cancer patients throughout their illness, from diagnosis to survivorship or end-of-life care. They work closely with other healthcare professionals, such as surgeons, radiation oncologists, radiologists, pathologists, and nurses, to provide comprehensive cancer care for their patients. The primary goal of medical oncology is to improve the quality of life and overall survival of cancer patients while minimizing side effects and toxicities associated with cancer treatments.

"Terminology as a topic" in the context of medical education and practice refers to the study and use of specialized language and terms within the field of medicine. This includes understanding the meaning, origins, and appropriate usage of medical terminology in order to effectively communicate among healthcare professionals and with patients. It may also involve studying the evolution and cultural significance of medical terminology. The importance of "terminology as a topic" lies in promoting clear and accurate communication, which is essential for providing safe and effective patient care.

Proportional hazards models are a type of statistical analysis used in medical research to investigate the relationship between covariates (predictor variables) and survival times. The most common application of proportional hazards models is in the Cox regression model, which is named after its developer, Sir David Cox.

In a proportional hazards model, the hazard rate or risk of an event occurring at a given time is assumed to be proportional to the hazard rate of a reference group, after adjusting for the covariates. This means that the ratio of the hazard rates between any two individuals remains constant over time, regardless of their survival times.

Mathematically, the hazard function h(t) at time t for an individual with a set of covariates X can be expressed as:

h(t|X) = h0(t) \* exp(β1X1 + β2X2 + ... + βpXp)

where h0(t) is the baseline hazard function, X1, X2, ..., Xp are the covariates, and β1, β2, ..., βp are the regression coefficients that represent the effect of each covariate on the hazard rate.

The assumption of proportionality is crucial in the interpretation of the results from a Cox regression model. If the assumption is violated, then the estimated regression coefficients may be biased and misleading. Therefore, it is important to test for the proportional hazards assumption before interpreting the results of a Cox regression analysis.

Rheumatoid arthritis (RA) is a systemic autoimmune disease that primarily affects the joints. It is characterized by persistent inflammation, synovial hyperplasia, and subsequent damage to the articular cartilage and bone. The immune system mistakenly attacks the body's own tissues, specifically targeting the synovial membrane lining the joint capsule. This results in swelling, pain, warmth, and stiffness in affected joints, often most severely in the hands and feet.

RA can also have extra-articular manifestations, affecting other organs such as the lungs, heart, skin, eyes, and blood vessels. The exact cause of RA remains unknown, but it is believed to involve a complex interplay between genetic susceptibility and environmental triggers. Early diagnosis and treatment are crucial in managing rheumatoid arthritis to prevent joint damage, disability, and systemic complications.

I'm sorry for any confusion, but "Markov Chains" is a term from the field of mathematics and probability theory, not medicine. Markov Chains are mathematical systems that undergo transitions from one state to another according to certain probabilistic rules. They are named after Russian mathematician Andrey Markov. These chains are used in various fields, including computer science, physics, economics, and engineering, but not commonly in medical definitions or contexts.

The United States Food and Drug Administration (FDA) is a federal government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our country's food supply, cosmetics, and products that emit radiation. The FDA also provides guidance on the proper use of these products, and enforces laws and regulations related to them. It is part of the Department of Health and Human Services (HHS).

Myocardial infarction (MI), also known as a heart attack, is a medical condition characterized by the death of a segment of heart muscle (myocardium) due to the interruption of its blood supply. This interruption is most commonly caused by the blockage of a coronary artery by a blood clot formed on the top of an atherosclerotic plaque, which is a buildup of cholesterol and other substances in the inner lining of the artery.

The lack of oxygen and nutrients supply to the heart muscle tissue results in damage or death of the cardiac cells, causing the affected area to become necrotic. The extent and severity of the MI depend on the size of the affected area, the duration of the occlusion, and the presence of collateral circulation.

Symptoms of a myocardial infarction may include chest pain or discomfort, shortness of breath, nausea, lightheadedness, and sweating. Immediate medical attention is necessary to restore blood flow to the affected area and prevent further damage to the heart muscle. Treatment options for MI include medications, such as thrombolytics, antiplatelet agents, and pain relievers, as well as procedures such as percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

An algorithm is not a medical term, but rather a concept from computer science and mathematics. In the context of medicine, algorithms are often used to describe step-by-step procedures for diagnosing or managing medical conditions. These procedures typically involve a series of rules or decision points that help healthcare professionals make informed decisions about patient care.

For example, an algorithm for diagnosing a particular type of heart disease might involve taking a patient's medical history, performing a physical exam, ordering certain diagnostic tests, and interpreting the results in a specific way. By following this algorithm, healthcare professionals can ensure that they are using a consistent and evidence-based approach to making a diagnosis.

Algorithms can also be used to guide treatment decisions. For instance, an algorithm for managing diabetes might involve setting target blood sugar levels, recommending certain medications or lifestyle changes based on the patient's individual needs, and monitoring the patient's response to treatment over time.

Overall, algorithms are valuable tools in medicine because they help standardize clinical decision-making and ensure that patients receive high-quality care based on the latest scientific evidence.

Investigational drugs, also known as experimental or trial drugs, refer to medications that are currently being tested in clinical trials to evaluate their safety and efficacy for the treatment of various medical conditions. These drugs have not yet been approved by regulatory agencies such as the US Food and Drug Administration (FDA) for general use.

Before entering clinical trials, investigational drugs must undergo extensive preclinical testing in the lab and on animals to assess their safety and potential therapeutic benefits. Clinical trials are conducted in phases, starting with small groups of healthy volunteers to assess safety, followed by larger groups of patients to evaluate efficacy and side effects.

Participation in clinical trials is voluntary, and participants must meet certain eligibility criteria to ensure their safety and the validity of the trial results. Investigational drugs may ultimately be approved for general use if they are found to be safe and effective in clinical trials.

Physician's practice patterns refer to the individual habits and preferences of healthcare providers when it comes to making clinical decisions and managing patient care. These patterns can encompass various aspects, such as:

1. Diagnostic testing: The types and frequency of diagnostic tests ordered for patients with similar conditions.
2. Treatment modalities: The choice of treatment options, including medications, procedures, or referrals to specialists.
3. Patient communication: The way physicians communicate with their patients, including the amount and type of information shared, as well as the level of patient involvement in decision-making.
4. Follow-up care: The frequency and duration of follow-up appointments, as well as the monitoring of treatment effectiveness and potential side effects.
5. Resource utilization: The use of healthcare resources, such as hospitalizations, imaging studies, or specialist consultations, and the associated costs.

Physician practice patterns can be influenced by various factors, including medical training, clinical experience, personal beliefs, guidelines, and local availability of resources. Understanding these patterns is essential for evaluating the quality of care, identifying potential variations in care, and implementing strategies to improve patient outcomes and reduce healthcare costs.

"Drug approval" is the process by which a regulatory agency, such as the US Food and Drug Administration (FDA), grants formal authorization for a pharmaceutical company to market and sell a drug for a specific medical condition. The approval process is based on rigorous evaluation of clinical trial data to ensure that the drug is safe and effective for its intended use.

The FDA's approval process typically involves several stages, including preclinical testing in the lab and animal studies, followed by three phases of clinical trials in human subjects. The first phase tests the safety of the drug in a small group of healthy volunteers, while the second and third phases test the drug's efficacy and side effects in larger groups of patients with the medical condition for which the drug is intended.

If the results of these studies demonstrate that the drug is safe and effective, the pharmaceutical company can submit a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA for review. The application includes data from the clinical trials, as well as information about the manufacturing process, labeling, and proposed use of the drug.

The FDA reviews the application and may seek input from independent experts before making a decision on whether to approve the drug. If approved, the drug can be marketed and sold to patients with the medical condition for which it was approved. The FDA continues to monitor the safety and efficacy of approved drugs after they reach the market to ensure that they remain safe and effective for their intended use.

Postmenopause is a stage in a woman's life that follows 12 months after her last menstrual period (menopause) has occurred. During this stage, the ovaries no longer release eggs and produce lower levels of estrogen and progesterone hormones. The reduced levels of these hormones can lead to various physical changes and symptoms, such as hot flashes, vaginal dryness, and mood changes. Postmenopause is also associated with an increased risk of certain health conditions, including osteoporosis and heart disease. It's important for women in postmenopause to maintain a healthy lifestyle, including regular exercise, a balanced diet, and routine medical check-ups to monitor their overall health and manage any potential risks.

An immunization schedule is a series of planned dates when a person, usually a child, should receive specific vaccines in order to be fully protected against certain preventable diseases. The schedule is developed based on scientific research and recommendations from health organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC).

The immunization schedule outlines which vaccines are recommended, the number of doses required, the age at which each dose should be given, and the minimum amount of time that must pass between doses. The schedule may vary depending on factors such as the individual's age, health status, and travel plans.

Immunization schedules are important for ensuring that individuals receive timely protection against vaccine-preventable diseases, and for maintaining high levels of immunity in populations, which helps to prevent the spread of disease. It is important to follow the recommended immunization schedule as closely as possible to ensure optimal protection.

Nontherapeutic human experimentation refers to medical research studies in which the primary goal is not to directly benefit the participants, but rather to advance scientific knowledge or develop new medical technologies. These studies often involve some level of risk or discomfort for the participants, and may include the administration of experimental treatments, procedures, or interventions.

Nontherapeutic human experimentation can take many forms, including clinical trials, observational studies, and other types of research involving human subjects. In these studies, researchers must carefully weigh the potential benefits of the research against the risks to the participants, and ensure that all participants are fully informed of the nature of the study, its purposes, and any potential risks or benefits before providing their consent to participate.

It's important to note that nontherapeutic human experimentation is subject to strict ethical guidelines and regulations, designed to protect the rights and welfare of research participants. These guidelines and regulations are intended to ensure that all research involving human subjects is conducted in a responsible and ethical manner, with the goal of advancing scientific knowledge while minimizing harm to participants.

"Research Support as Topic" is not a specific medical term or diagnosis. However, in the context of medical literature and research, "research support" refers to the resources, funding, and infrastructure that enable and facilitate the conduct of scientific research. This can include financial support from various sources such as government agencies, private organizations, or institutions; access to laboratory facilities, equipment, and databases; and technical assistance in study design, data collection and analysis, and manuscript preparation.

When "research support" is designated as a topic in medical literature, it typically refers to articles that discuss the various aspects of research funding, ethics, and management, including best practices for grant writing, financial conflict of interest disclosures, and responsible conduct of research. It may also include studies that examine the impact of research support on the quality, quantity, and outcomes of scientific research.

Hypertension is a medical term used to describe abnormally high blood pressure in the arteries, often defined as consistently having systolic blood pressure (the top number in a blood pressure reading) over 130 mmHg and/or diastolic blood pressure (the bottom number) over 80 mmHg. It is also commonly referred to as high blood pressure.

Hypertension can be classified into two types: primary or essential hypertension, which has no identifiable cause and accounts for about 95% of cases, and secondary hypertension, which is caused by underlying medical conditions such as kidney disease, hormonal disorders, or use of certain medications.

If left untreated, hypertension can lead to serious health complications such as heart attack, stroke, heart failure, and chronic kidney disease. Therefore, it is important for individuals with hypertension to manage their condition through lifestyle modifications (such as healthy diet, regular exercise, stress management) and medication if necessary, under the guidance of a healthcare professional.

Oral administration is a route of giving medications or other substances by mouth. This can be in the form of tablets, capsules, liquids, pastes, or other forms that can be swallowed. Once ingested, the substance is absorbed through the gastrointestinal tract and enters the bloodstream to reach its intended target site in the body. Oral administration is a common and convenient route of medication delivery, but it may not be appropriate for all substances or in certain situations, such as when rapid onset of action is required or when the patient has difficulty swallowing.

"Drug evaluation" is a medical term that refers to the systematic process of assessing the pharmacological, therapeutic, and safety profile of a drug or medication. This process typically involves several stages, including preclinical testing in the laboratory, clinical trials in human subjects, and post-marketing surveillance.

The goal of drug evaluation is to determine the efficacy, safety, and optimal dosage range of a drug, as well as any potential interactions with other medications or medical conditions. The evaluation process also includes an assessment of the drug's pharmacokinetics, or how it is absorbed, distributed, metabolized, and eliminated by the body.

The findings from drug evaluations are used to inform regulatory decisions about whether a drug should be approved for use in clinical practice, as well as to provide guidance to healthcare providers about how to use the drug safely and effectively.

A conflict of interest (COI) is a situation in which a person or organization has dual loyalties or is in a position to exploit their professional or personal relationships for personal or institutional gain. In the medical field, COIs can arise when healthcare providers, researchers, or institutions have financial or other interests that may influence their judgment or actions in providing care, conducting research, or making recommendations.

Examples of conflicts of interest in medicine include:

* A physician who has a financial relationship with a pharmaceutical company and receives compensation for promoting the company's products to patients or colleagues.
* A researcher who owns stock in a company that is funding their study and may stand to benefit financially from positive results.
* An institution that accepts funding from industry partners for research or educational programs, which could potentially influence the outcomes of the research or bias the education provided.

COIs can compromise the integrity of medical research, patient care, and professional judgment. Therefore, it is essential to disclose and manage COIs transparently to maintain trust in the healthcare system and ensure that decisions are made in the best interests of patients and society as a whole.

Patient compliance, also known as medication adherence or patient adherence, refers to the degree to which a patient's behavior matches the agreed-upon recommendations from their healthcare provider. This includes taking medications as prescribed (including the correct dosage, frequency, and duration), following dietary restrictions, making lifestyle changes, and attending follow-up appointments. Poor patient compliance can negatively impact treatment outcomes and lead to worsening of symptoms, increased healthcare costs, and development of drug-resistant strains in the case of antibiotics. It is a significant challenge in healthcare and efforts are being made to improve patient education, communication, and support to enhance compliance.

Health planning guidelines are a set of recommendations and principles that provide direction for the development, implementation, and evaluation of health services and public health programs. These guidelines serve as a framework to ensure that health planning is evidence-based, equitable, efficient, and effective in addressing the priority health needs of a population. They typically cover various aspects such as:

1. Needs assessment: Identifying and prioritizing the health needs of a population through data collection, analysis, and consultation with stakeholders.
2. Resource allocation: Determining how to distribute resources fairly and efficiently to address priority health issues and ensure equitable access to healthcare services.
3. Service delivery: Establishing standards for the provision of high-quality, patient-centered care that is accessible, affordable, and culturally sensitive.
4. Monitoring and evaluation: Developing systems to track progress towards health goals, measure outcomes, and make data-driven decisions for continuous quality improvement.
5. Stakeholder engagement: Encouraging collaboration and partnership among various stakeholders, including healthcare providers, policymakers, community organizations, and the public, to ensure that health planning efforts are inclusive, participatory, and responsive to local needs and preferences.
6. Ethical considerations: Ensuring that health planning processes and decisions respect human rights, promote social justice, and protect vulnerable populations from discrimination and marginalization.
7. Flexibility and adaptability: Recognizing the need for regular review and revision of health planning guidelines to accommodate changing circumstances, emerging evidence, and new priorities.

I'm sorry for any confusion, but "publishing" is not a term that has a medical definition. Publishing typically refers to the process of preparing and disseminating information, such as books, journals, or articles, to the public or a specific audience. It could involve both print and digital media. If you have any questions related to medicine or healthcare, I'd be happy to try to help answer those!

Heart failure is a pathophysiological state in which the heart is unable to pump sufficient blood to meet the metabolic demands of the body or do so only at the expense of elevated filling pressures. It can be caused by various cardiac disorders, including coronary artery disease, hypertension, valvular heart disease, cardiomyopathy, and arrhythmias. Symptoms may include shortness of breath, fatigue, and fluid retention. Heart failure is often classified based on the ejection fraction (EF), which is the percentage of blood that is pumped out of the left ventricle during each contraction. A reduced EF (less than 40%) is indicative of heart failure with reduced ejection fraction (HFrEF), while a preserved EF (greater than or equal to 50%) is indicative of heart failure with preserved ejection fraction (HFpEF). There is also a category of heart failure with mid-range ejection fraction (HFmrEF) for those with an EF between 40-49%.

Disease-free survival (DFS) is a term used in medical research and clinical practice, particularly in the field of oncology. It refers to the length of time after primary treatment for a cancer during which no evidence of the disease can be found. This means that the patient shows no signs or symptoms of the cancer, and any imaging studies or other tests do not reveal any tumors or other indications of the disease.

DFS is often used as an important endpoint in clinical trials to evaluate the effectiveness of different treatments for cancer. By measuring the length of time until the cancer recurs or a new cancer develops, researchers can get a better sense of how well a particular treatment is working and whether it is improving patient outcomes.

It's important to note that DFS is not the same as overall survival (OS), which refers to the length of time from primary treatment until death from any cause. While DFS can provide valuable information about the effectiveness of cancer treatments, it does not necessarily reflect the impact of those treatments on patients' overall survival.

"Quality control" is a term that is used in many industries, including healthcare and medicine, to describe the systematic process of ensuring that products or services meet certain standards and regulations. In the context of healthcare, quality control often refers to the measures taken to ensure that the care provided to patients is safe, effective, and consistent. This can include processes such as:

1. Implementing standardized protocols and guidelines for care
2. Training and educating staff to follow these protocols
3. Regularly monitoring and evaluating the outcomes of care
4. Making improvements to processes and systems based on data and feedback
5. Ensuring that equipment and supplies are maintained and functioning properly
6. Implementing systems for reporting and addressing safety concerns or errors.

The goal of quality control in healthcare is to provide high-quality, patient-centered care that meets the needs and expectations of patients, while also protecting their safety and well-being.

Medical survival rate is a statistical measure used to determine the percentage of patients who are still alive for a specific period of time after their diagnosis or treatment for a certain condition or disease. It is often expressed as a five-year survival rate, which refers to the proportion of people who are alive five years after their diagnosis. Survival rates can be affected by many factors, including the stage of the disease at diagnosis, the patient's age and overall health, the effectiveness of treatment, and other health conditions that the patient may have. It is important to note that survival rates are statistical estimates and do not necessarily predict an individual patient's prognosis.

I'm sorry for any confusion, but "International Cooperation" is not a medical term. It refers to the collaboration and exchange of resources and information between countries or international organizations in various fields, including politics, economics, culture, environment, and security, among others. In the context of healthcare and medicine, international cooperation can involve joint research projects, sharing of data and clinical trial results, collaborative efforts to combat global health issues (such as infectious diseases or chronic conditions), capacity building in low-resource settings, and standardizing medical practices and guidelines across countries.

Vaccination is a simple, safe, and effective way to protect people against harmful diseases, before they come into contact with them. It uses your body's natural defenses to build protection to specific infections and makes your immune system stronger.

A vaccination usually contains a small, harmless piece of a virus or bacteria (or toxins produced by these germs) that has been made inactive or weakened so it won't cause the disease itself. This piece of the germ is known as an antigen. When the vaccine is introduced into the body, the immune system recognizes the antigen as foreign and produces antibodies to fight it.

If a person then comes into contact with the actual disease-causing germ, their immune system will recognize it and immediately produce antibodies to destroy it. The person is therefore protected against that disease. This is known as active immunity.

Vaccinations are important for both individual and public health. They prevent the spread of contagious diseases and protect vulnerable members of the population, such as young children, the elderly, and people with weakened immune systems who cannot be vaccinated or for whom vaccination is not effective.

A feasibility study is a preliminary investigation or analysis conducted to determine the viability of a proposed project, program, or product. In the medical field, feasibility studies are often conducted before implementing new treatments, procedures, equipment, or facilities. These studies help to assess the practicality and effectiveness of the proposed intervention, as well as its potential benefits and risks.

Feasibility studies in healthcare typically involve several steps:

1. Problem identification: Clearly define the problem that the proposed project, program, or product aims to address.
2. Objectives setting: Establish specific, measurable, achievable, relevant, and time-bound (SMART) objectives for the study.
3. Literature review: Conduct a thorough review of existing research and best practices related to the proposed intervention.
4. Methodology development: Design a methodology for data collection and analysis that will help answer the research questions and achieve the study's objectives.
5. Resource assessment: Evaluate the availability and adequacy of resources, including personnel, time, and finances, required to carry out the proposed intervention.
6. Risk assessment: Identify potential risks and challenges associated with the implementation of the proposed intervention and develop strategies to mitigate them.
7. Cost-benefit analysis: Estimate the costs and benefits of the proposed intervention, including direct and indirect costs, as well as short-term and long-term benefits.
8. Stakeholder engagement: Engage relevant stakeholders, such as patients, healthcare providers, administrators, and policymakers, to gather their input and support for the proposed intervention.
9. Decision-making: Based on the findings of the feasibility study, make an informed decision about whether or not to proceed with the proposed project, program, or product.

Feasibility studies are essential in healthcare as they help ensure that resources are allocated efficiently and effectively, and that interventions are evidence-based, safe, and beneficial for patients.

Animal experimentation, also known as animal testing, refers to the use of non-human animals in scientific research and testing to understand the effects of various substances, treatments, or procedures on living organisms. This practice is performed with the goal of advancing medical and veterinary knowledge, developing new medications, treatments, and surgical techniques, as well as studying basic biological processes and diseases.

In animal experimentation, researchers expose animals to specific conditions, treatments, or substances and then analyze their responses, behaviors, physiological changes, or other outcomes. The selection of animal species for these experiments depends on the research question and the similarities between the animal model and the human or target species under investigation. Commonly used animals include mice, rats, rabbits, guinea pigs, hamsters, primates, and dogs.

Animal experimentation has been instrumental in numerous scientific breakthroughs and medical advancements throughout history. However, it remains a controversial topic due to ethical concerns regarding the treatment and welfare of animals used in research. Many organizations advocate for the reduction, refinement, or replacement (3Rs) of animal testing, aiming to minimize animal suffering and find alternative methods whenever possible.

Research personnel, in the context of medical and scientific research, refers to individuals who are involved in the design, conduct, or reporting of research studies. This can include, but is not limited to, principal investigators, co-investigators, research assistants, research coordinators, data managers, biostatisticians, and laboratory technicians. These individuals may have various levels of education, training, and expertise, and their roles and responsibilities will depend on the specific research study and their individual qualifications. It is important for research personnel to adhere to ethical guidelines and regulations in order to ensure the integrity and validity of research findings.

I apologize, but "Canada" is not a medical term or concept. It is a country located in North America, known for its vast wilderness, multicultural cities, and significant natural resources. If you have any questions related to healthcare or medical terms, I would be happy to help answer those!

The placebo effect is a psychological or psychophysiological phenomenon in which a person's symptoms improve following a treatment but this improvement is not attributable to the properties of the treatment itself. Instead, it is believed to be due to the mind's belief in the effectiveness of the treatment, often influenced by positive expectations and the ritualistic aspects of the therapy itself.

Placebos are often used in clinical trials as a control group to compare against the actual treatment. The placebo effect can make it challenging to determine whether an observed improvement is truly due to the treatment or other factors.

Pain measurement, in a medical context, refers to the quantification or evaluation of the intensity and/or unpleasantness of a patient's subjective pain experience. This is typically accomplished through the use of standardized self-report measures such as numerical rating scales (NRS), visual analog scales (VAS), or categorical scales (mild, moderate, severe). In some cases, physiological measures like heart rate, blood pressure, and facial expressions may also be used to supplement self-reported pain ratings. The goal of pain measurement is to help healthcare providers better understand the nature and severity of a patient's pain in order to develop an effective treatment plan.

Neoplasm staging is a systematic process used in medicine to describe the extent of spread of a cancer, including the size and location of the original (primary) tumor and whether it has metastasized (spread) to other parts of the body. The most widely accepted system for this purpose is the TNM classification system developed by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC).

In this system, T stands for tumor, and it describes the size and extent of the primary tumor. N stands for nodes, and it indicates whether the cancer has spread to nearby lymph nodes. M stands for metastasis, and it shows whether the cancer has spread to distant parts of the body.

Each letter is followed by a number that provides more details about the extent of the disease. For example, a T1N0M0 cancer means that the primary tumor is small and has not spread to nearby lymph nodes or distant sites. The higher the numbers, the more advanced the cancer.

Staging helps doctors determine the most appropriate treatment for each patient and estimate the patient's prognosis. It is an essential tool for communication among members of the healthcare team and for comparing outcomes of treatments in clinical trials.

Patient participation refers to the active involvement of patients in their own healthcare process. This includes:

1. Making informed decisions about their health and treatment options in partnership with healthcare professionals.
2. Communicating effectively with healthcare providers to ensure their needs, preferences, and values are taken into account.
3. Monitoring their own health status and seeking appropriate care when needed.
4. Providing feedback on the quality of care they receive to help improve healthcare services.

Patient participation is considered a key component of patient-centered care, which aims to treat patients as whole persons with unique needs, values, and preferences, rather than simply treating their medical conditions. It is also an essential element of shared decision-making, where patients and healthcare providers work together to make informed decisions based on the best available evidence and the patient's individual circumstances.

A dietary supplement is a product that contains nutrients, such as vitamins, minerals, amino acids, herbs or other botanicals, and is intended to be taken by mouth, to supplement the diet. Dietary supplements can include a wide range of products, such as vitamin and mineral supplements, herbal supplements, and sports nutrition products.

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They are intended to be used as a way to add extra nutrients to the diet or to support specific health functions. It is important to note that dietary supplements are not subject to the same rigorous testing and regulations as drugs, so it is important to choose products carefully and consult with a healthcare provider if you have any questions or concerns about using them.

Government regulation in the context of medicine refers to the rules, guidelines, and laws established by government agencies to control, monitor, and standardize various aspects of healthcare. These regulations are designed to protect patients, promote public health, ensure quality of care, and regulate the healthcare industry. Examples of government regulation in medicine include:

1. Food and Drug Administration (FDA) regulations for drug approval, medical device clearance, and food safety.
2. Centers for Medicare & Medicaid Services (CMS) regulations for healthcare reimbursement, quality measures, and program eligibility.
3. Occupational Safety and Health Administration (OSHA) regulations for workplace safety in healthcare settings.
4. Environmental Protection Agency (EPA) regulations to minimize environmental impacts from healthcare facilities and pharmaceutical manufacturing.
5. State medical boards' regulations for licensing, disciplining, and monitoring physicians and other healthcare professionals.
6. Health Insurance Portability and Accountability Act (HIPAA) regulations for patient privacy and data security.
7. Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory testing quality and standards.
8. Federal Trade Commission (FTC) regulations to prevent deceptive or unfair trade practices in healthcare marketing and advertising.
9. Agency for Healthcare Research and Quality (AHRQ) guidelines for evidence-based practice and patient safety.
10. Public Health Service Act (PHSA) regulations related to infectious diseases, bioterrorism preparedness, and substance abuse treatment.

A computer simulation is a process that involves creating a model of a real-world system or phenomenon on a computer and then using that model to run experiments and make predictions about how the system will behave under different conditions. In the medical field, computer simulations are used for a variety of purposes, including:

1. Training and education: Computer simulations can be used to create realistic virtual environments where medical students and professionals can practice their skills and learn new procedures without risk to actual patients. For example, surgeons may use simulation software to practice complex surgical techniques before performing them on real patients.
2. Research and development: Computer simulations can help medical researchers study the behavior of biological systems at a level of detail that would be difficult or impossible to achieve through experimental methods alone. By creating detailed models of cells, tissues, organs, or even entire organisms, researchers can use simulation software to explore how these systems function and how they respond to different stimuli.
3. Drug discovery and development: Computer simulations are an essential tool in modern drug discovery and development. By modeling the behavior of drugs at a molecular level, researchers can predict how they will interact with their targets in the body and identify potential side effects or toxicities. This information can help guide the design of new drugs and reduce the need for expensive and time-consuming clinical trials.
4. Personalized medicine: Computer simulations can be used to create personalized models of individual patients based on their unique genetic, physiological, and environmental characteristics. These models can then be used to predict how a patient will respond to different treatments and identify the most effective therapy for their specific condition.

Overall, computer simulations are a powerful tool in modern medicine, enabling researchers and clinicians to study complex systems and make predictions about how they will behave under a wide range of conditions. By providing insights into the behavior of biological systems at a level of detail that would be difficult or impossible to achieve through experimental methods alone, computer simulations are helping to advance our understanding of human health and disease.

Research, in the context of medicine, is a systematic and rigorous process of collecting, analyzing, and interpreting information in order to increase our understanding, develop new knowledge, or evaluate current practices and interventions. It can involve various methodologies such as observational studies, experiments, surveys, or literature reviews. The goal of medical research is to advance health care by identifying new treatments, improving diagnostic techniques, and developing prevention strategies. Medical research is typically conducted by teams of researchers including clinicians, scientists, and other healthcare professionals. It is subject to ethical guidelines and regulations to ensure that it is conducted responsibly and with the best interests of patients in mind.

Exercise therapy is a type of medical treatment that uses physical movement and exercise to improve a patient's physical functioning, mobility, and overall health. It is often used as a component of rehabilitation programs for individuals who have experienced injuries, illnesses, or surgeries that have impaired their ability to move and function normally.

Exercise therapy may involve a range of activities, including stretching, strengthening, balance training, aerobic exercise, and functional training. The specific exercises used will depend on the individual's needs, goals, and medical condition.

The benefits of exercise therapy include:

* Improved strength and flexibility
* Increased endurance and stamina
* Enhanced balance and coordination
* Reduced pain and inflammation
* Improved cardiovascular health
* Increased range of motion and joint mobility
* Better overall physical functioning and quality of life.

Exercise therapy is typically prescribed and supervised by a healthcare professional, such as a physical therapist or exercise physiologist, who has experience working with individuals with similar medical conditions. The healthcare professional will create an individualized exercise program based on the patient's needs and goals, and will provide guidance and support to ensure that the exercises are performed safely and effectively.

Intention-to-treat (ITT) analysis is a principle used in the design and interpretation of clinical trials, where all participants who are randomly assigned to a treatment group, regardless of whether they receive or complete the intended intervention, are included in the final analysis. The primary aim of ITT analysis is to mirror real-world scenarios as closely as possible by preserving the original randomization scheme and accounting for potential confounding factors, such as dropouts, protocol deviations, or crossovers between treatment groups.

In an ITT analysis, participants are analyzed in their originally assigned groups, even if they do not receive the intended intervention or switch to another group during the study. This approach helps maintain the balance of prognostic factors across treatment groups and reduces bias that may arise from selective exclusion of non-compliant or non-adherent individuals.

The ITT principle is particularly important in superiority trials, where the primary goal is to demonstrate a significant difference between two interventions. By including all participants in the analysis, researchers can minimize potential biases and maintain statistical power, ensuring that the results are more generalizable to the broader target population. However, it is essential to recognize that ITT analyses may underestimate treatment effects compared to per-protocol or as-treated analyses, which only include participants who adhere to their assigned intervention.

In summary, an intention-to-treat analysis is a medical research principle in clinical trials where all randomly assigned participants are analyzed in their original groups, regardless of whether they receive or complete the intended intervention. This approach helps maintain statistical power and reduce bias, providing results that are more generalizable to real-world scenarios.

"Random allocation," also known as "random assignment" or "randomization," is a process used in clinical trials and other research studies to distribute participants into different intervention groups (such as experimental group vs. control group) in a way that minimizes selection bias and ensures the groups are comparable at the start of the study.

In random allocation, each participant has an equal chance of being assigned to any group, and the assignment is typically made using a computer-generated randomization schedule or other objective methods. This process helps to ensure that any differences between the groups are due to the intervention being tested rather than pre-existing differences in the participants' characteristics.

Decision-making is the cognitive process of selecting a course of action from among multiple alternatives. In a medical context, decision-making refers to the process by which healthcare professionals and patients make choices about medical tests, treatments, or management options based on a thorough evaluation of available information, including the patient's preferences, values, and circumstances.

The decision-making process in medicine typically involves several steps:

1. Identifying the problem or issue that requires a decision.
2. Gathering relevant information about the patient's medical history, current condition, diagnostic test results, treatment options, and potential outcomes.
3. Considering the benefits, risks, and uncertainties associated with each option.
4. Evaluating the patient's preferences, values, and goals.
5. Selecting the most appropriate course of action based on a careful weighing of the available evidence and the patient's individual needs and circumstances.
6. Communicating the decision to the patient and ensuring that they understand the rationale behind it, as well as any potential risks or benefits.
7. Monitoring the outcomes of the decision and adjusting the course of action as needed based on ongoing evaluation and feedback.

Effective decision-making in medicine requires a thorough understanding of medical evidence, clinical expertise, and patient preferences. It also involves careful consideration of ethical principles, such as respect for autonomy, non-maleficence, beneficence, and justice. Ultimately, the goal of decision-making in healthcare is to promote the best possible outcomes for patients while minimizing harm and respecting their individual needs and values.

A drug combination refers to the use of two or more drugs in combination for the treatment of a single medical condition or disease. The rationale behind using drug combinations is to achieve a therapeutic effect that is superior to that obtained with any single agent alone, through various mechanisms such as:

* Complementary modes of action: When different drugs target different aspects of the disease process, their combined effects may be greater than either drug used alone.
* Synergistic interactions: In some cases, the combination of two or more drugs can result in a greater-than-additive effect, where the total response is greater than the sum of the individual responses to each drug.
* Antagonism of adverse effects: Sometimes, the use of one drug can mitigate the side effects of another, allowing for higher doses or longer durations of therapy.

Examples of drug combinations include:

* Highly active antiretroviral therapy (HAART) for HIV infection, which typically involves a combination of three or more antiretroviral drugs to suppress viral replication and prevent the development of drug resistance.
* Chemotherapy regimens for cancer treatment, where combinations of cytotoxic agents are used to target different stages of the cell cycle and increase the likelihood of tumor cell death.
* Fixed-dose combination products, such as those used in the treatment of hypertension or type 2 diabetes, which combine two or more active ingredients into a single formulation for ease of administration and improved adherence to therapy.

However, it's important to note that drug combinations can also increase the risk of adverse effects, drug-drug interactions, and medication errors. Therefore, careful consideration should be given to the selection of appropriate drugs, dosing regimens, and monitoring parameters when using drug combinations in clinical practice.

A newborn infant is a baby who is within the first 28 days of life. This period is also referred to as the neonatal period. Newborns require specialized care and attention due to their immature bodily systems and increased vulnerability to various health issues. They are closely monitored for signs of well-being, growth, and development during this critical time.

A cross-over study is a type of experimental design in which participants receive two or more interventions in a specific order. After a washout period, each participant receives the opposite intervention(s). The primary advantage of this design is that it controls for individual variability by allowing each participant to act as their own control.

In medical research, cross-over studies are often used to compare the efficacy or safety of two treatments. For example, a researcher might conduct a cross-over study to compare the effectiveness of two different medications for treating high blood pressure. Half of the participants would be randomly assigned to receive one medication first and then switch to the other medication after a washout period. The other half of the participants would receive the opposite order of treatments.

Cross-over studies can provide valuable insights into the relative merits of different interventions, but they also have some limitations. For example, they may not be suitable for studying conditions that are chronic or irreversible, as it may not be possible to completely reverse the effects of the first intervention before administering the second one. Additionally, carryover effects from the first intervention can confound the results if they persist into the second treatment period.

Overall, cross-over studies are a useful tool in medical research when used appropriately and with careful consideration of their limitations.

Pregnancy is a physiological state or condition where a fertilized egg (zygote) successfully implants and grows in the uterus of a woman, leading to the development of an embryo and finally a fetus. This process typically spans approximately 40 weeks, divided into three trimesters, and culminates in childbirth. Throughout this period, numerous hormonal and physical changes occur to support the growing offspring, including uterine enlargement, breast development, and various maternal adaptations to ensure the fetus's optimal growth and well-being.

Patient education, as defined by the US National Library of Medicine's Medical Subject Headings (MeSH), is "the teaching or training of patients concerning their own health needs. It includes the patient's understanding of his or her condition and the necessary procedures for self, assisted, or professional care." This encompasses a wide range of activities and interventions aimed at helping patients and their families understand their medical conditions, treatment options, self-care skills, and overall health management. Effective patient education can lead to improved health outcomes, increased patient satisfaction, and better use of healthcare resources.

I'm sorry for any confusion, but "History, 20th Century" is a broad and complex topic that refers to the events, developments, and transformations that occurred throughout the world during the 1900s. It is not a medical term or concept. If you're interested in learning more about this historical period, I would recommend consulting a history textbook, reputable online resources, or speaking with a historian. They can provide detailed information about the political, social, economic, and cultural changes that took place during the 20th century.

The Kaplan-Meier estimate is a statistical method used to calculate the survival probability over time in a population. It is commonly used in medical research to analyze time-to-event data, such as the time until a patient experiences a specific event like disease progression or death. The Kaplan-Meier estimate takes into account censored data, which occurs when some individuals are lost to follow-up before experiencing the event of interest.

The method involves constructing a survival curve that shows the proportion of subjects still surviving at different time points. At each time point, the survival probability is calculated as the product of the conditional probabilities of surviving from one time point to the next. The Kaplan-Meier estimate provides an unbiased and consistent estimator of the survival function, even when censoring is present.

In summary, the Kaplan-Meier estimate is a crucial tool in medical research for analyzing time-to-event data and estimating survival probabilities over time while accounting for censored observations.

Patient satisfaction is a concept in healthcare quality measurement that reflects the patient's perspective and evaluates their experience with the healthcare services they have received. It is a multidimensional construct that includes various aspects such as interpersonal mannerisms of healthcare providers, technical competence, accessibility, timeliness, comfort, and communication.

Patient satisfaction is typically measured through standardized surveys or questionnaires that ask patients to rate their experiences on various aspects of care. The results are often used to assess the quality of care provided by healthcare organizations, identify areas for improvement, and inform policy decisions. However, it's important to note that patient satisfaction is just one aspect of healthcare quality and should be considered alongside other measures such as clinical outcomes and patient safety.

Editorial policies refer to a set of guidelines and principles that govern the development, selection, peer-review, production, and publication of manuscripts in a medical journal. These policies aim to ensure the integrity, transparency, and quality of the published research while adhering to ethical standards and best practices in scientific publishing.

Some essential components of editorial policies include:

1. Authorship criteria: Defining who qualifies as an author, their roles, and responsibilities, and specifying the order of authorship based on contribution.
2. Conflict of interest disclosure: Requiring authors, reviewers, and editors to declare any potential conflicts of interest that may influence their judgment or objectivity in the manuscript's evaluation.
3. Peer-review process: Outlining the steps involved in the peer-review process, including the selection of reviewers, the number of required reviews, and the criteria for accepting or rejecting a manuscript.
4. Plagiarism detection: Employing plagiarism detection software to ensure originality and prevent unethical practices such as self-plagiarism or duplicate publication.
5. Data sharing: Encouraging or requiring authors to share their data, code, or materials to promote transparency and reproducibility of the research findings.
6. Corrections and retractions: Establishing procedures for correcting errors, addressing scientific misconduct, and retracting published articles when necessary.
7. Post-publication discussions: Encouraging open dialogue and constructive criticism through post-publication discussions or letters to the editor.
8. Accessibility and copyright: Describing how the journal ensures accessibility of its content, such as through open-access models, and outlining the terms of copyright and licensing agreements.
9. Archiving and preservation: Ensuring long-term preservation and availability of published content by depositing it in appropriate digital archives or repositories.
10. Compliance with international standards: Adhering to guidelines and best practices established by organizations such as the International Committee of Medical Journal Editors (ICMJE), the World Association of Medical Editors (WAME), and the Committee on Publication Ethics (COPE).

Peer review in the context of research refers to the evaluation of scientific, academic, or professional work by others working in the same field. The purpose of peer review is to ensure that the research is rigorous, valid, and relevant to the field. In a peer-review process, experts in the relevant field assess the research article, report, or other type of scholarly work for its accuracy, quality, and significance before it is published or presented at a conference.

The peer-review process typically involves several stages:

1. Submission: The author(s) submit their manuscript to a journal, conference, or other publication venue.
2. Assignment: The editor of the publication assigns the manuscript to one or more reviewers who are experts in the field.
3. Review: The reviewers evaluate the manuscript based on criteria such as originality, methodology, data analysis, interpretation of results, and contribution to the field. They provide feedback and recommendations to the editor.
4. Decision: Based on the feedback from the reviewers, the editor makes a decision about whether to accept, reject, or request revisions to the manuscript.
5. Revision: If the manuscript is rejected or requires revisions, the author(s) may have an opportunity to revise and resubmit the manuscript for further consideration.

Peer review is a critical component of the scientific process, as it helps ensure that research is held to high standards of quality and integrity. It also provides a mechanism for identifying and correcting errors or weaknesses in research before it is published or disseminated widely.

In the context of healthcare, "safety" refers to the freedom from harm or injury that is intentionally designed into a process, system, or environment. It involves the prevention of adverse events or injuries, as well as the reduction of risk and the mitigation of harm when accidents do occur. Safety in healthcare aims to protect patients, healthcare workers, and other stakeholders from potential harm associated with medical care, treatments, or procedures. This is achieved through evidence-based practices, guidelines, protocols, training, and continuous quality improvement efforts.

The Predictive Value of Tests, specifically the Positive Predictive Value (PPV) and Negative Predictive Value (NPV), are measures used in diagnostic tests to determine the probability that a positive or negative test result is correct.

Positive Predictive Value (PPV) is the proportion of patients with a positive test result who actually have the disease. It is calculated as the number of true positives divided by the total number of positive results (true positives + false positives). A higher PPV indicates that a positive test result is more likely to be a true positive, and therefore the disease is more likely to be present.

Negative Predictive Value (NPV) is the proportion of patients with a negative test result who do not have the disease. It is calculated as the number of true negatives divided by the total number of negative results (true negatives + false negatives). A higher NPV indicates that a negative test result is more likely to be a true negative, and therefore the disease is less likely to be present.

The predictive value of tests depends on the prevalence of the disease in the population being tested, as well as the sensitivity and specificity of the test. A test with high sensitivity and specificity will generally have higher predictive values than a test with low sensitivity and specificity. However, even a highly sensitive and specific test can have low predictive values if the prevalence of the disease is low in the population being tested.

A biological marker, often referred to as a biomarker, is a measurable indicator that reflects the presence or severity of a disease state, or a response to a therapeutic intervention. Biomarkers can be found in various materials such as blood, tissues, or bodily fluids, and they can take many forms, including molecular, histologic, radiographic, or physiological measurements.

In the context of medical research and clinical practice, biomarkers are used for a variety of purposes, such as:

1. Diagnosis: Biomarkers can help diagnose a disease by indicating the presence or absence of a particular condition. For example, prostate-specific antigen (PSA) is a biomarker used to detect prostate cancer.
2. Monitoring: Biomarkers can be used to monitor the progression or regression of a disease over time. For instance, hemoglobin A1c (HbA1c) levels are monitored in diabetes patients to assess long-term blood glucose control.
3. Predicting: Biomarkers can help predict the likelihood of developing a particular disease or the risk of a negative outcome. For example, the presence of certain genetic mutations can indicate an increased risk for breast cancer.
4. Response to treatment: Biomarkers can be used to evaluate the effectiveness of a specific treatment by measuring changes in the biomarker levels before and after the intervention. This is particularly useful in personalized medicine, where treatments are tailored to individual patients based on their unique biomarker profiles.

It's important to note that for a biomarker to be considered clinically valid and useful, it must undergo rigorous validation through well-designed studies, including demonstrating sensitivity, specificity, reproducibility, and clinical relevance.

Intravenous (IV) infusion is a medical procedure in which liquids, such as medications, nutrients, or fluids, are delivered directly into a patient's vein through a needle or a catheter. This route of administration allows for rapid absorption and distribution of the infused substance throughout the body. IV infusions can be used for various purposes, including resuscitation, hydration, nutrition support, medication delivery, and blood product transfusion. The rate and volume of the infusion are carefully controlled to ensure patient safety and efficacy of treatment.

Lung neoplasms refer to abnormal growths or tumors in the lung tissue. These tumors can be benign (non-cancerous) or malignant (cancerous). Malignant lung neoplasms are further classified into two main types: small cell lung carcinoma and non-small cell lung carcinoma. Lung neoplasms can cause symptoms such as cough, chest pain, shortness of breath, and weight loss. They are often caused by smoking or exposure to secondhand smoke, but can also occur due to genetic factors, radiation exposure, and other environmental carcinogens. Early detection and treatment of lung neoplasms is crucial for improving outcomes and survival rates.

In the context of medicine, "consensus" generally refers to a general agreement or accord reached among a group of medical professionals or experts regarding a particular clinical issue, treatment recommendation, or research direction. This consensus may be based on a review and evaluation of available scientific evidence, as well as consideration of clinical experience and patient values. Consensus-building processes can take various forms, such as formal consensus conferences, Delphi methods, or nominal group techniques. It is important to note that while consensus can help guide medical decision making, it does not necessarily equate with established scientific fact and should be considered alongside other sources of evidence in clinical practice.

Analysis of Variance (ANOVA) is a statistical technique used to compare the means of two or more groups and determine whether there are any significant differences between them. It is a way to analyze the variance in a dataset to determine whether the variability between groups is greater than the variability within groups, which can indicate that the groups are significantly different from one another.

ANOVA is based on the concept of partitioning the total variance in a dataset into two components: variance due to differences between group means (also known as "between-group variance") and variance due to differences within each group (also known as "within-group variance"). By comparing these two sources of variance, ANOVA can help researchers determine whether any observed differences between groups are statistically significant, or whether they could have occurred by chance.

ANOVA is a widely used technique in many areas of research, including biology, psychology, engineering, and business. It is often used to compare the means of two or more experimental groups, such as a treatment group and a control group, to determine whether the treatment had a significant effect. ANOVA can also be used to compare the means of different populations or subgroups within a population, to identify any differences that may exist between them.

A "periodical" in the context of medicine typically refers to a type of publication that is issued regularly, such as on a monthly or quarterly basis. These publications include peer-reviewed journals, magazines, and newsletters that focus on medical research, education, and practice. They may contain original research articles, review articles, case reports, editorials, letters to the editor, and other types of content related to medical science and clinical practice.

As a "Topic," periodicals in medicine encompass various aspects such as their role in disseminating new knowledge, their impact on clinical decision-making, their quality control measures, and their ethical considerations. Medical periodicals serve as a crucial resource for healthcare professionals, researchers, students, and other stakeholders to stay updated on the latest developments in their field and to share their findings with others.

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. It typically contains an agent that resembles the disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it encounters in the future.

Vaccines can be prophylactic (to prevent or ameliorate the effects of a future infection by a natural or "wild" pathogen), or therapeutic (to fight disease that is already present). The administration of vaccines is called vaccination. Vaccinations are generally administered through needle injections, but can also be administered by mouth or sprayed into the nose.

The term "vaccine" comes from Edward Jenner's 1796 use of cowpox to create immunity to smallpox. The first successful vaccine was developed in 1796 by Edward Jenner, who showed that milkmaids who had contracted cowpox did not get smallpox. He reasoned that exposure to cowpox protected against smallpox and tested his theory by injecting a boy with pus from a cowpox sore and then exposing him to smallpox, which the boy did not contract. The word "vaccine" is derived from Variolae vaccinae (smallpox of the cow), the term devised by Jenner to denote cowpox. He used it in 1798 during a conversation with a fellow physician and later in the title of his 1801 Inquiry.

Drug-related side effects and adverse reactions refer to any unintended or harmful outcome that occurs during the use of a medication. These reactions can be mild or severe and may include predictable, known responses (side effects) as well as unexpected, idiosyncratic reactions (adverse effects). Side effects are typically related to the pharmacologic properties of the drug and occur at therapeutic doses, while adverse reactions may result from allergic or hypersensitivity reactions, overdoses, or interactions with other medications or substances.

Side effects are often dose-dependent and can be managed by adjusting the dose, frequency, or route of administration. Adverse reactions, on the other hand, may require discontinuation of the medication or treatment with antidotes or supportive care. It is important for healthcare providers to monitor patients closely for any signs of drug-related side effects and adverse reactions and to take appropriate action when necessary.

In medical terms, disclosure generally refers to the act of revealing or sharing confidential or sensitive information with another person or entity. This can include disclosing a patient's medical history, diagnosis, treatment plan, or other personal health information to the patient themselves, their family members, or other healthcare providers involved in their care.

Disclosure is an important aspect of informed consent, as patients have the right to know their medical condition and the risks and benefits of various treatment options. Healthcare providers are required to disclose relevant information to their patients in a clear and understandable manner, so that they can make informed decisions about their healthcare.

In some cases, disclosure may also be required by law or professional ethical standards, such as when there is a legal obligation to report certain types of injuries or illnesses, or when there is a concern for patient safety. It is important for healthcare providers to carefully consider the potential risks and benefits of disclosure in each individual case, and to ensure that they are acting in the best interests of their patients while also protecting their privacy and confidentiality.

Cognitive Therapy (CT) is a type of psychotherapeutic treatment that helps patients understand the thoughts and feelings that influence behaviors. It is a form of talk therapy where the therapist and the patient work together to identify and change negative or distorted thinking patterns and beliefs, with the goal of improving emotional response and behavior.

Cognitive Therapy is based on the idea that our thoughts, feelings, and behaviors are all interconnected, and that negative or inaccurate thoughts can contribute to problems like anxiety and depression. By identifying and challenging these thoughts, patients can learn to think more realistically and positively, which can lead to improvements in their mood and behavior.

In cognitive therapy sessions, the therapist will help the patient identify negative thought patterns and replace them with healthier, more accurate ways of thinking. The therapist may also assign homework or exercises for the patient to practice between sessions, such as keeping a thought record or challenging negative thoughts.

Cognitive Therapy has been shown to be effective in treating a wide range of mental health conditions, including depression, anxiety disorders, eating disorders, and post-traumatic stress disorder (PTSD). It is often used in combination with other forms of treatment, such as medication, and can be delivered individually or in group settings.

Treatment failure is a term used in medicine to describe the situation when a prescribed treatment or intervention is not achieving the desired therapeutic goals or objectives. This may occur due to various reasons, such as:

1. Development of drug resistance by the pathogen or disease being treated.
2. Inadequate dosage or frequency of the medication.
3. Poor adherence or compliance to the treatment regimen by the patient.
4. The presence of underlying conditions or comorbidities that may affect the efficacy of the treatment.
5. The severity or progression of the disease despite appropriate treatment.

When treatment failure occurs, healthcare providers may need to reassess the patient's condition and modify the treatment plan accordingly, which may include adjusting the dosage, changing the medication, adding new medications, or considering alternative treatments.

Consent forms are documents used in medical settings to obtain a patient's voluntary and informed agreement to undergo a specific medical procedure, treatment, or participate in research. These forms typically outline the nature of the proposed intervention, its purpose, risks, benefits, alternatives, and any potential complications or side effects. The patient is provided with sufficient time and opportunity to ask questions, seek clarification, and discuss concerns with their healthcare provider before making a decision. By signing the consent form, the patient acknowledges that they have been fully informed about the proposed intervention and understand its implications. Consent forms serve as legal records of the patient's authorization for the medical procedure or treatment, protecting both the patient and the healthcare provider in case of any disputes or complications.

Formal social control, in the context of medical sociology or health sciences, refers to the systematic mechanisms and processes through which society regulates and guides the behavior of its members in accordance with established laws, rules, and norms, particularly in relation to health and healthcare. This can include various formal institutions and agencies such as governmental bodies, regulatory authorities, professional organizations, and healthcare providers that are responsible for enforcing standards, policies, and regulations aimed at ensuring quality, safety, and effectiveness of healthcare services and products.

Examples of formal social control in healthcare may include licensing and accreditation requirements for healthcare professionals and facilities, clinical guidelines and protocols for diagnosis and treatment, quality improvement initiatives, and regulatory oversight of pharmaceuticals and medical devices. These mechanisms help to maintain order, promote compliance with ethical and professional standards, and protect the public's health and well-being.

A cohort study is a type of observational study in which a group of individuals who share a common characteristic or exposure are followed up over time to determine the incidence of a specific outcome or outcomes. The cohort, or group, is defined based on the exposure status (e.g., exposed vs. unexposed) and then monitored prospectively to assess for the development of new health events or conditions.

Cohort studies can be either prospective or retrospective in design. In a prospective cohort study, participants are enrolled and followed forward in time from the beginning of the study. In contrast, in a retrospective cohort study, researchers identify a cohort that has already been assembled through medical records, insurance claims, or other sources and then look back in time to assess exposure status and health outcomes.

Cohort studies are useful for establishing causality between an exposure and an outcome because they allow researchers to observe the temporal relationship between the two. They can also provide information on the incidence of a disease or condition in different populations, which can be used to inform public health policy and interventions. However, cohort studies can be expensive and time-consuming to conduct, and they may be subject to bias if participants are not representative of the population or if there is loss to follow-up.

Microbial sensitivity tests, also known as antibiotic susceptibility tests (ASTs) or bacterial susceptibility tests, are laboratory procedures used to determine the effectiveness of various antimicrobial agents against specific microorganisms isolated from a patient's infection. These tests help healthcare providers identify which antibiotics will be most effective in treating an infection and which ones should be avoided due to resistance. The results of these tests can guide appropriate antibiotic therapy, minimize the potential for antibiotic resistance, improve clinical outcomes, and reduce unnecessary side effects or toxicity from ineffective antimicrobials.

There are several methods for performing microbial sensitivity tests, including:

1. Disk diffusion method (Kirby-Bauer test): A standardized paper disk containing a predetermined amount of an antibiotic is placed on an agar plate that has been inoculated with the isolated microorganism. After incubation, the zone of inhibition around the disk is measured to determine the susceptibility or resistance of the organism to that particular antibiotic.
2. Broth dilution method: A series of tubes or wells containing decreasing concentrations of an antimicrobial agent are inoculated with a standardized microbial suspension. After incubation, the minimum inhibitory concentration (MIC) is determined by observing the lowest concentration of the antibiotic that prevents visible growth of the organism.
3. Automated systems: These use sophisticated technology to perform both disk diffusion and broth dilution methods automatically, providing rapid and accurate results for a wide range of microorganisms and antimicrobial agents.

The interpretation of microbial sensitivity test results should be done cautiously, considering factors such as the site of infection, pharmacokinetics and pharmacodynamics of the antibiotic, potential toxicity, and local resistance patterns. Regular monitoring of susceptibility patterns and ongoing antimicrobial stewardship programs are essential to ensure optimal use of these tests and to minimize the development of antibiotic resistance.

Nonparametric statistics is a branch of statistics that does not rely on assumptions about the distribution of variables in the population from which the sample is drawn. In contrast to parametric methods, nonparametric techniques make fewer assumptions about the data and are therefore more flexible in their application. Nonparametric tests are often used when the data do not meet the assumptions required for parametric tests, such as normality or equal variances.

Nonparametric statistical methods include tests such as the Wilcoxon rank-sum test (also known as the Mann-Whitney U test) for comparing two independent groups, the Wilcoxon signed-rank test for comparing two related groups, and the Kruskal-Wallis test for comparing more than two independent groups. These tests use the ranks of the data rather than the actual values to make comparisons, which allows them to be used with ordinal or continuous data that do not meet the assumptions of parametric tests.

Overall, nonparametric statistics provide a useful set of tools for analyzing data in situations where the assumptions of parametric methods are not met, and can help researchers draw valid conclusions from their data even when the data are not normally distributed or have other characteristics that violate the assumptions of parametric tests.

A chronic disease is a long-term medical condition that often progresses slowly over a period of years and requires ongoing management and care. These diseases are typically not fully curable, but symptoms can be managed to improve quality of life. Common chronic diseases include heart disease, stroke, cancer, diabetes, arthritis, and COPD (chronic obstructive pulmonary disease). They are often associated with advanced age, although they can also affect children and younger adults. Chronic diseases can have significant impacts on individuals' physical, emotional, and social well-being, as well as on healthcare systems and society at large.

Guideline adherence, in the context of medicine, refers to the extent to which healthcare professionals follow established clinical practice guidelines or recommendations in their daily practice. These guidelines are systematically developed statements designed to assist practitioners and patient decisions about appropriate health care for specific clinical circumstances. Adherence to evidence-based guidelines can help improve the quality of care, reduce unnecessary variations in practice, and promote optimal patient outcomes. Factors that may influence guideline adherence include clinician awareness, familiarity, agreement, self-efficacy, outcome expectancy, and the complexity of the recommendation.

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. It is a complex phenomenon that can result from various stimuli, such as thermal, mechanical, or chemical irritation, and it can be acute or chronic. The perception of pain involves the activation of specialized nerve cells called nociceptors, which transmit signals to the brain via the spinal cord. These signals are then processed in different regions of the brain, leading to the conscious experience of pain. It's important to note that pain is a highly individual and subjective experience, and its perception can vary widely among individuals.

Antifungal agents are a type of medication used to treat and prevent fungal infections. These agents work by targeting and disrupting the growth of fungi, which include yeasts, molds, and other types of fungi that can cause illness in humans.

There are several different classes of antifungal agents, including:

1. Azoles: These agents work by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. Examples of azole antifungals include fluconazole, itraconazole, and voriconazole.
2. Echinocandins: These agents target the fungal cell wall, disrupting its synthesis and leading to fungal cell death. Examples of echinocandins include caspofungin, micafungin, and anidulafungin.
3. Polyenes: These agents bind to ergosterol in the fungal cell membrane, creating pores that lead to fungal cell death. Examples of polyene antifungals include amphotericin B and nystatin.
4. Allylamines: These agents inhibit squalene epoxidase, a key enzyme in ergosterol synthesis. Examples of allylamine antifungals include terbinafine and naftifine.
5. Griseofulvin: This agent disrupts fungal cell division by binding to tubulin, a protein involved in fungal cell mitosis.

Antifungal agents can be administered topically, orally, or intravenously, depending on the severity and location of the infection. It is important to use antifungal agents only as directed by a healthcare professional, as misuse or overuse can lead to resistance and make treatment more difficult.

Institutional ethics refers to the ethical principles, guidelines, and practices that are established and implemented within organizations or institutions, particularly those involved in healthcare, research, and other fields where ethical considerations are paramount. Institutional ethics committees (IECs) or institutional review boards (IRBs) are often established to oversee and ensure the ethical conduct of research, clinical trials, and other activities within the institution.

Institutional ethics committees typically consist of a multidisciplinary group of individuals who represent various stakeholders, including healthcare professionals, researchers, community members, and ethicists. The committee's role is to review and approve proposed research studies, ensure that they adhere to ethical guidelines and regulations, protect the rights and welfare of study participants, and monitor ongoing research to identify and address any ethical concerns that may arise during the course of the study.

Institutional ethics also encompasses broader organizational values, policies, and practices that promote ethical behavior and decision-making within the institution. This includes developing and implementing codes of conduct, providing education and training on ethical issues, fostering a culture of transparency and accountability, and promoting open communication and dialogue around ethical concerns.

Overall, institutional ethics plays a critical role in ensuring that organizations and institutions operate in an ethically responsible manner, promote the well-being of their stakeholders, and maintain public trust and confidence.

An ethicist is a person who specializes in the study of ethics, which involves systematizing, defending, and recommending concepts of right and wrong conduct. In medical context, an ethicist is a person who applies ethical theories and principles to address complex issues in healthcare, medicine, and research involving clinical ethics, research ethics, and public health ethics. Medical ethicists may serve as consultants, educators, or researchers to help patients, families, healthcare professionals, and institutions analyze, clarify, and resolve ethical dilemmas related to medical care, treatment decisions, resource allocation, and policy development. They may hold various academic degrees in philosophy, theology, law, medicine, or other relevant fields, and have expertise in bioethics, moral theory, applied ethics, and clinical ethics consultation.

Melanoma is defined as a type of cancer that develops from the pigment-containing cells known as melanocytes. It typically occurs in the skin but can rarely occur in other parts of the body, including the eyes and internal organs. Melanoma is characterized by the uncontrolled growth and multiplication of melanocytes, which can form malignant tumors that invade and destroy surrounding tissue.

Melanoma is often caused by exposure to ultraviolet (UV) radiation from the sun or tanning beds, but it can also occur in areas of the body not exposed to the sun. It is more likely to develop in people with fair skin, light hair, and blue or green eyes, but it can affect anyone, regardless of their skin type.

Melanoma can be treated effectively if detected early, but if left untreated, it can spread to other parts of the body and become life-threatening. Treatment options for melanoma include surgery, radiation therapy, chemotherapy, immunotherapy, and targeted therapy, depending on the stage and location of the cancer. Regular skin examinations and self-checks are recommended to detect any changes or abnormalities in moles or other pigmented lesions that may indicate melanoma.

Phytotherapy is the use of extracts of natural origin, especially plants or plant parts, for therapeutic purposes. It is also known as herbal medicine and is a traditional practice in many cultures. The active compounds in these plant extracts are believed to have various medicinal properties, such as anti-inflammatory, analgesic, or sedative effects. Practitioners of phytotherapy may use the whole plant, dried parts, or concentrated extracts to prepare teas, capsules, tinctures, or ointments for therapeutic use. It is important to note that the effectiveness and safety of phytotherapy are not always supported by scientific evidence, and it should be used with caution and preferably under the guidance of a healthcare professional.

I must apologize, but there seems to be a misunderstanding. The term "internationality" is not a commonly used medical term with a specific definition in the field of medicine or healthcare. It is a more general term that can refer to the quality or state of being international or global in scope, relevance, or application. If you have any questions related to medical terminology or health-related topics, I would be happy to try and help clarify those for you.

"Dissent and disputes" in a medical context generally refer to disagreements or differences of opinion among healthcare professionals, researchers, or patients regarding medical diagnoses, treatments, policies, or ethical issues. These disputes can arise from various factors such as differing clinical experiences, conflicting scientific evidence, differing values and beliefs, or lack of clear guidelines. Dissent and disputes can be resolved through open communication, evidence-based decision making, consensus building, and, when necessary, mediation or arbitration. It is essential to address dissent and disputes in a respectful and constructive manner to ensure the best possible outcomes for patients and to advance medical knowledge and practice.

Investigational therapies, also known as experimental or investigational new drugs (INDs), refer to treatments or interventions that are currently being studied and have not yet been approved for general use by regulatory authorities such as the US Food and Drug Administration (FDA). These therapies may include new drugs, biologics, medical devices, procedures, or behavioral interventions.

Investigational therapies are typically tested in clinical trials to assess their safety, efficacy, and optimal dosage. The process of testing an investigational therapy can take several years and involves multiple phases of research, including preclinical studies (testing in the lab), phase I trials (safety testing in a small group of people), phase II trials (testing for effectiveness and side effects in a larger group of people), and phase III trials (large-scale testing to confirm effectiveness, monitor side effects, and collect information that will allow the therapy to be used safely).

Participation in clinical trials of investigational therapies is voluntary and usually requires informed consent from the participant. Investigational therapies may offer hope for people with serious or life-threatening conditions who have exhausted all other treatment options, but they also carry risks, as their safety and efficacy have not yet been fully established.

The European Union (EU) is not a medical term or organization, but rather a political and economic union of 27 European countries. It is primarily involved in matters related to policy, law, and trade, and does not have a direct role in the provision or regulation of healthcare services, except in certain specific areas such as pharmaceutical regulations and cross-border healthcare directives.

Therefore, there is no medical definition for "European Union."

"Evaluation studies" is a broad term that refers to the systematic assessment or examination of a program, project, policy, intervention, or product. The goal of an evaluation study is to determine its merits, worth, and value by measuring its effects, efficiency, and impact. There are different types of evaluation studies, including formative evaluations (conducted during the development or implementation of a program to provide feedback for improvement), summative evaluations (conducted at the end of a program to determine its overall effectiveness), process evaluations (focusing on how a program is implemented and delivered), outcome evaluations (assessing the short-term and intermediate effects of a program), and impact evaluations (measuring the long-term and broad consequences of a program).

In medical contexts, evaluation studies are often used to assess the safety, efficacy, and cost-effectiveness of new treatments, interventions, or technologies. These studies can help healthcare providers make informed decisions about patient care, guide policymakers in developing evidence-based policies, and promote accountability and transparency in healthcare systems. Examples of evaluation studies in medicine include randomized controlled trials (RCTs) that compare the outcomes of a new treatment to those of a standard or placebo treatment, observational studies that examine the real-world effectiveness and safety of interventions, and economic evaluations that assess the costs and benefits of different healthcare options.

The American Medical Association (AMA) is the largest professional organization of physicians and medical students in the United States. The AMA's mission is to promote the art and science of medicine and the betterment of public health. It aims to achieve this by providing leadership and advocacy for the medical profession, supporting the development and application of scientific and ethical standards in medical practice, and promoting public health.

The AMA develops policies on various medical and healthcare issues, including medical education, patient care, medical research, and reimbursement and payment policies. It also publishes several medical journals, including JAMA (Journal of the American Medical Association) and the Archives of Internal Medicine. The AMA is headquartered in Chicago, Illinois, and has a membership of more than 200,000 physicians and medical students.

Product surveillance, postmarketing refers to the ongoing monitoring and evaluation of a pharmaceutical or medical device product after it has been approved and released on the market. This process is used to detect any safety issues, adverse effects, or product performance concerns that may not have been identified during clinical trials. The data collected from postmarketing surveillance helps regulatory agencies, such as the U.S. Food and Drug Administration (FDA), to make informed decisions about the continued use, modification, or withdrawal of a product from the market. Postmarketing surveillance is an essential component of post-market risk management and helps ensure the safety and efficacy of medical products throughout their lifecycle.

Program Evaluation is a systematic and objective assessment of a healthcare program's design, implementation, and outcomes. It is a medical term used to describe the process of determining the relevance, effectiveness, and efficiency of a program in achieving its goals and objectives. Program evaluation involves collecting and analyzing data related to various aspects of the program, such as its reach, impact, cost-effectiveness, and quality. The results of program evaluation can be used to improve the design and implementation of existing programs or to inform the development of new ones. It is a critical tool for ensuring that healthcare programs are meeting the needs of their intended audiences and delivering high-quality care in an efficient and effective manner.

Bioethical issues refer to the ethical dilemmas and challenges that arise in biological research, healthcare, and medical technology. These issues often involve conflicts between scientific or medical advancements and moral, social, legal, and cultural values. Examples of bioethical issues include:

1. End-of-life care: Decisions about life-sustaining treatments, such as artificial nutrition and hydration, mechanical ventilation, and do-not-resuscitate orders, can raise ethical questions about the quality of life, patient autonomy, and the role of healthcare providers.
2. Genetic testing and screening: The use of genetic information for medical decision-making, predictive testing, and reproductive choices can have significant implications for individuals, families, and society, raising concerns about privacy, discrimination, and informed consent.
3. Organ transplantation: Issues surrounding organ donation and allocation, such as fairness, scarcity, and the definition of death, can create ethical dilemmas that require careful consideration of medical, legal, and moral principles.
4. Stem cell research: The use of embryonic stem cells for research and therapy raises questions about the moral status of embryos, potential therapeutic benefits, and the role of government in regulating scientific research.
5. Assisted reproductive technologies (ART): Techniques such as in vitro fertilization (IVF), surrogacy, and gamete donation can challenge traditional notions of family, parenthood, and reproduction, leading to debates about the rights and interests of children, parents, and society.
6. Mental health treatment: The use of psychotropic medications, electroconvulsive therapy (ECT), and other interventions for mental illness can raise concerns about patient autonomy, informed consent, and the balance between therapeutic benefits and potential risks.
7. Public health emergencies: Responses to infectious disease outbreaks, bioterrorism, and other public health crises can involve difficult decisions about resource allocation, individual rights, and the role of government in protecting population health.
8. Research involving human subjects: The ethical conduct of clinical trials, observational studies, and other research that involves human participants requires careful consideration of issues such as informed consent, risk-benefit analysis, and respect for participant autonomy and privacy.
9. Health care access and financing: Debates about health care reform, insurance coverage, and affordability can raise questions about the role of government in ensuring access to essential medical services, the balance between individual rights and social responsibility, and the ethical implications of rationing limited resources.
10. Global health ethics: Issues such as international cooperation, resource distribution, and cultural sensitivity can challenge traditional notions of global justice, human rights, and the responsibilities of wealthy nations to address health disparities in low- and middle-income countries.

Triazoles are a class of antifungal medications that have broad-spectrum activity against various fungi, including yeasts, molds, and dermatophytes. They work by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, leading to increased permeability and disruption of fungal growth. Triazoles are commonly used in both systemic and topical formulations for the treatment of various fungal infections, such as candidiasis, aspergillosis, cryptococcosis, and dermatophytoses. Some examples of triazole antifungals include fluconazole, itraconazole, voriconazole, and posaconazole.

Translational medical research, also known as "translational research," refers to the process of turning basic scientific discoveries into clinical interventions that improve human health and well-being. This type of research aims to "translate" findings from laboratory, animal, or cellular studies into practical applications for the prevention, diagnosis, and treatment of human diseases.

Translational medical research typically involves a multidisciplinary approach, bringing together researchers from various fields such as biology, chemistry, engineering, genetics, and medicine to work collaboratively on solving complex health problems. The process often includes several stages, including:

1. Identifying basic scientific discoveries that have the potential to be translated into clinical applications.
2. Developing and optimizing new diagnostic tools, drugs, or therapies based on these discoveries.
3. Conducting preclinical studies in the laboratory or with animal models to evaluate the safety and efficacy of these interventions.
4. Designing and implementing clinical trials to test the effectiveness and safety of the new interventions in human patients.
5. Disseminating research findings to the scientific community, healthcare providers, and the public to facilitate the adoption of new practices or treatments.

Translational medical research is essential for bridging the gap between basic scientific discoveries and clinical applications, ultimately improving patient care and outcomes.

Immunotherapy is a type of medical treatment that uses the body's own immune system to fight against diseases, such as cancer. It involves the use of substances (like vaccines, medications, or immune cells) that stimulate or suppress the immune system to help it recognize and destroy harmful disease-causing cells or agents, like tumor cells.

Immunotherapy can work in several ways:

1. Activating the immune system: Certain immunotherapies boost the body's natural immune responses, helping them recognize and attack cancer cells more effectively.
2. Suppressing immune system inhibitors: Some immunotherapies target and block proteins or molecules that can suppress the immune response, allowing the immune system to work more efficiently against diseases.
3. Replacing or enhancing specific immune cells: Immunotherapy can also involve administering immune cells (like T-cells) that have been genetically engineered or modified to recognize and destroy cancer cells.

Immunotherapies have shown promising results in treating various types of cancer, autoimmune diseases, and allergies. However, they can also cause side effects, as an overactive immune system may attack healthy tissues and organs. Therefore, careful monitoring is necessary during immunotherapy treatment.

The World Health Organization (WHO) is not a medical condition or term, but rather a specialized agency of the United Nations responsible for international public health. Here's a brief description:

The World Health Organization (WHO) is a specialized agency of the United Nations that acts as the global authority on public health issues. Established in 1948, WHO's primary role is to coordinate and collaborate with its member states to promote health, prevent diseases, and ensure universal access to healthcare services. WHO is headquartered in Geneva, Switzerland, and has regional offices around the world. It plays a crucial role in setting global health standards, monitoring disease outbreaks, and providing guidance on various public health concerns, including infectious diseases, non-communicable diseases, mental health, environmental health, and maternal, newborn, child, and adolescent health.

Multivariate analysis is a statistical method used to examine the relationship between multiple independent variables and a dependent variable. It allows for the simultaneous examination of the effects of two or more independent variables on an outcome, while controlling for the effects of other variables in the model. This technique can be used to identify patterns, associations, and interactions among multiple variables, and is commonly used in medical research to understand complex health outcomes and disease processes. Examples of multivariate analysis methods include multiple regression, factor analysis, cluster analysis, and discriminant analysis.

In the context of medicine, risk is the probability or likelihood of an adverse health effect or the occurrence of a negative event related to treatment or exposure to certain hazards. It is usually expressed as a ratio or percentage and can be influenced by various factors such as age, gender, lifestyle, genetics, and environmental conditions. Risk assessment involves identifying, quantifying, and prioritizing risks to make informed decisions about prevention, mitigation, or treatment strategies.

I'm sorry for any confusion, but "Internet" is a term that pertains to the global network of interconnected computers and servers that enable the transmission and reception of data via the internet protocol (IP). It is not a medical term and does not have a specific medical definition. If you have any questions related to medicine or health, I'd be happy to try to help answer them for you!

Local neoplasm recurrence is the return or regrowth of a tumor in the same location where it was originally removed or treated. This means that cancer cells have survived the initial treatment and started to grow again in the same area. It's essential to monitor and detect any local recurrence as early as possible, as it can affect the prognosis and may require additional treatment.

The term "Congresses as Topic" refers to large, formal meetings that are held to discuss and exchange information on a specific topic or field, usually academic or professional in nature. In the context of medical science, a congress is an event where healthcare professionals, researchers, and experts gather to present and discuss the latest research, developments, and innovations in their field. Medical congresses can cover a wide range of topics, including specific diseases, treatments, medical specialties, public health issues, or healthcare policies. These events often include keynote speeches, panel discussions, workshops, poster sessions, and networking opportunities for attendees. Examples of well-known medical congresses are the annual meetings of the American Medical Association, the American Heart Association, and the European Society of Cardiology.

"Academies and Institutes" in a medical context typically refer to organizations that are dedicated to advancing knowledge, research, and education in a specific field of medicine or healthcare. These organizations often bring together experts and leaders in the field to share knowledge, conduct research, and develop guidelines or policies. They may also provide training and certification for healthcare professionals.

Examples of medical academies and institutes include:

* The National Academy of Medicine (NAM) in the United States, which provides independent, objective analysis and advice to the nation on medical and health issues.
* The Royal College of Physicians (RCP) in the United Kingdom, which is a professional body dedicated to improving the practice of medicine, with a particular focus on physicians.
* The American Heart Association (AHA) and the American College of Cardiology (ACC), which are two leading organizations focused on cardiovascular disease and healthcare.
* The World Health Organization (WHO) is an international organization that coordinates and directs global health activities, including research, policy-making, and service delivery.

These institutions play a crucial role in shaping medical practice and policy by providing evidence-based recommendations and guidelines, as well as training and certification for healthcare professionals.

Quality Assurance in the context of healthcare refers to a systematic approach and set of activities designed to ensure that health care services and products consistently meet predetermined standards of quality and safety. It includes all the policies, procedures, and processes that are put in place to monitor, assess, and improve the quality of healthcare delivery.

The goal of quality assurance is to minimize variability in clinical practice, reduce medical errors, and ensure that patients receive evidence-based care that is safe, effective, timely, patient-centered, and equitable. Quality assurance activities may include:

1. Establishing standards of care based on best practices and clinical guidelines.
2. Developing and implementing policies and procedures to ensure compliance with these standards.
3. Providing education and training to healthcare professionals to improve their knowledge and skills.
4. Conducting audits, reviews, and evaluations of healthcare services and processes to identify areas for improvement.
5. Implementing corrective actions to address identified issues and prevent their recurrence.
6. Monitoring and measuring outcomes to evaluate the effectiveness of quality improvement initiatives.

Quality assurance is an ongoing process that requires continuous evaluation and improvement to ensure that healthcare delivery remains safe, effective, and patient-centered.

Preclinical drug evaluation refers to a series of laboratory tests and studies conducted to determine the safety and effectiveness of a new drug before it is tested in humans. These studies typically involve experiments on cells and animals to evaluate the pharmacological properties, toxicity, and potential interactions with other substances. The goal of preclinical evaluation is to establish a reasonable level of safety and understanding of how the drug works, which helps inform the design and conduct of subsequent clinical trials in humans. It's important to note that while preclinical studies provide valuable information, they may not always predict how a drug will behave in human subjects.

"Recovery of function" is a term used in medical rehabilitation to describe the process in which an individual regains the ability to perform activities or tasks that were previously difficult or impossible due to injury, illness, or disability. This can involve both physical and cognitive functions. The goal of recovery of function is to help the person return to their prior level of independence and participation in daily activities, work, and social roles as much as possible.

Recovery of function may be achieved through various interventions such as physical therapy, occupational therapy, speech-language therapy, and other rehabilitation strategies. The specific approach used will depend on the individual's needs and the nature of their impairment. Recovery of function can occur spontaneously as the body heals, or it may require targeted interventions to help facilitate the process.

It is important to note that recovery of function does not always mean a full return to pre-injury or pre-illness levels of ability. Instead, it often refers to the person's ability to adapt and compensate for any remaining impairments, allowing them to achieve their maximum level of functional independence and quality of life.

Publication bias refers to the tendency of researchers, editors, and pharmaceutical companies to handle and publish research results in a way that depends on the nature and direction of the study findings. This type of bias is particularly common in clinical trials related to medical interventions or treatments.

In publication bias, studies with positive or "statistically significant" results are more likely to be published and disseminated than those with negative or null results. This can occur for various reasons, such as the reluctance of researchers and sponsors to report negative findings, or the preference of journal editors to publish positive and novel results that are more likely to attract readers and citations.

Publication bias can lead to a distorted view of the scientific evidence, as it may overemphasize the benefits and underestimate the risks or limitations of medical interventions. This can have serious consequences for clinical decision-making, patient care, and public health policies. Therefore, it is essential to minimize publication bias by encouraging and facilitating the registration, reporting, and dissemination of all research results, regardless of their outcome.

I'm sorry for any confusion, but "Germany" is not a medical term or concept. It is the name of a country in central Europe. If you have any questions related to medical topics, I would be happy to try and help answer those for you!

Influenza vaccines, also known as flu shots, are vaccines that protect against the influenza virus. Influenza is a highly contagious respiratory illness that can cause severe symptoms and complications, particularly in young children, older adults, pregnant women, and people with certain underlying health conditions.

Influenza vaccines contain inactivated or weakened viruses or pieces of the virus, which stimulate the immune system to produce antibodies that recognize and fight off the virus. The vaccine is typically given as an injection into the muscle, usually in the upper arm.

There are several different types of influenza vaccines available, including:

* Trivalent vaccines, which protect against three strains of the virus (two A strains and one B strain)
* Quadrivalent vaccines, which protect against four strains of the virus (two A strains and two B strains)
* High-dose vaccines, which contain a higher amount of antigen and are recommended for people aged 65 and older
* Adjuvanted vaccines, which contain an additional ingredient to boost the immune response and are also recommended for people aged 65 and older
* Cell-based vaccines, which are produced using cultured cells rather than eggs and may be recommended for people with egg allergies

It's important to note that influenza viruses are constantly changing, so the vaccine is updated each year to match the circulating strains. It's recommended that most people get vaccinated against influenza every year to stay protected.

The American Heart Association (AHA) is a non-profit organization in the United States that aims to reduce disability and death from cardiovascular diseases and stroke, including heart disease and stroke. The AHA was founded in 1924 and is one of the oldest and largest voluntary organizations dedicated to fighting cardiovascular disease.

The AHA provides a range of services, including:

* Funding research into the causes, prevention, and treatment of heart disease and stroke
* Providing educational resources for healthcare professionals, patients, and the general public
* Advocating for policies that promote heart health and prevent heart disease and stroke
* Developing guidelines and standards for the diagnosis, treatment, and prevention of cardiovascular diseases

The AHA is funded through donations from individuals, corporations, and foundations. It operates with a volunteer board of directors and a professional staff. The organization has more than 3,400 volunteers and 70 local offices across the United States.

Clinical ethics refers to the branch of applied ethics that deals with ethical issues in clinical settings, such as hospitals and other healthcare facilities. It involves the application of moral principles and values to decision-making in clinical practice, with the aim of promoting patient autonomy, beneficence, non-maleficence, and justice.

Clinical ethics often involves addressing complex ethical dilemmas that arise in the context of patient care, such as end-of-life decisions, informed consent, confidentiality, resource allocation, and research involving human subjects. Clinical ethicists may work as part of an institutional ethics committee or provide consultation services to healthcare providers, patients, and families facing ethical challenges.

The principles of clinical ethics are grounded in respect for patient autonomy, which includes the right to make informed decisions about their own care. Beneficence refers to the obligation to act in the best interests of the patient, while non-maleficence involves avoiding harm to the patient. Justice requires fair and equitable distribution of healthcare resources and respect for the rights and dignity of all patients.

Effective clinical ethics decision-making also involves careful consideration of contextual factors, such as cultural differences, religious beliefs, and social values, that may influence ethical judgments in particular cases. Clinical ethicists use a variety of methods to analyze ethical issues, including case consultation, ethical analysis frameworks, and moral deliberation processes that involve all stakeholders in the decision-making process.

Molecular targeted therapy is a type of treatment that targets specific molecules involved in the growth, progression, and spread of cancer. These molecules can be proteins, genes, or other molecules that contribute to the development of cancer. By targeting these specific molecules, molecular targeted therapy aims to block the abnormal signals that promote cancer growth and progression, thereby inhibiting or slowing down the growth of cancer cells while minimizing harm to normal cells.

Examples of molecular targeted therapies include monoclonal antibodies, tyrosine kinase inhibitors, angiogenesis inhibitors, and immunotherapies that target specific immune checkpoints. These therapies can be used alone or in combination with other cancer treatments such as chemotherapy, radiation therapy, or surgery. The goal of molecular targeted therapy is to improve the effectiveness of cancer treatment while reducing side effects and improving quality of life for patients.

Costs refer to the total amount of resources, such as money, time, and labor, that are expended in the provision of a medical service or treatment. Costs can be categorized into direct costs, which include expenses directly related to patient care, such as medication, supplies, and personnel; and indirect costs, which include overhead expenses, such as rent, utilities, and administrative salaries.

Cost analysis is the process of estimating and evaluating the total cost of a medical service or treatment. This involves identifying and quantifying all direct and indirect costs associated with the provision of care, and analyzing how these costs may vary based on factors such as patient volume, resource utilization, and reimbursement rates.

Cost analysis is an important tool for healthcare organizations to understand the financial implications of their operations and make informed decisions about resource allocation, pricing strategies, and quality improvement initiatives. It can also help policymakers and payers evaluate the cost-effectiveness of different treatment options and develop evidence-based guidelines for clinical practice.

A "Research Report" in the medical context is a comprehensive and systematic documentation of the entire process, findings, and conclusions of a scientific research study. It typically includes an abstract, introduction, methodology, results, discussion, and conclusion sections. The report may also contain information about the funding sources, potential conflicts of interest, and ethical considerations related to the research. The purpose of a research report is to allow other researchers to critically evaluate the study, replicate its findings, and build upon its knowledge. It should adhere to strict standards of scientific reporting and be written in a clear, concise, and objective manner.

Cancer vaccines are a type of immunotherapy that stimulate the body's own immune system to recognize and destroy cancer cells. They can be prophylactic (preventive) or therapeutic (treatment) in nature. Prophylactic cancer vaccines, such as the human papillomavirus (HPV) vaccine, are designed to prevent the initial infection that can lead to certain types of cancer. Therapeutic cancer vaccines, on the other hand, are used to treat existing cancer by boosting the immune system's ability to identify and eliminate cancer cells. These vaccines typically contain specific antigens (proteins or sugars) found on the surface of cancer cells, which help the immune system to recognize and target them.

It is important to note that cancer vaccines are different from vaccines used to prevent infectious diseases, such as measles or influenza. While traditional vaccines introduce a weakened or inactivated form of a virus or bacteria to stimulate an immune response, cancer vaccines focus on training the immune system to recognize and attack cancer cells specifically.

There are several types of cancer vaccines under investigation, including:

1. Autologous cancer vaccines: These vaccines use the patient's own tumor cells, which are processed and then reintroduced into the body to stimulate an immune response.
2. Peptide-based cancer vaccines: These vaccines contain specific pieces (peptides) of proteins found on the surface of cancer cells. They are designed to trigger an immune response against cells that express these proteins.
3. Dendritic cell-based cancer vaccines: Dendritic cells are a type of immune cell responsible for presenting antigens to other immune cells, activating them to recognize and destroy infected or cancerous cells. In this approach, dendritic cells are isolated from the patient's blood, exposed to cancer antigens in the lab, and then reintroduced into the body to stimulate an immune response.
4. DNA-based cancer vaccines: These vaccines use pieces of DNA that code for specific cancer antigens. Once inside the body, these DNA fragments are taken up by cells, leading to the production of the corresponding antigen and triggering an immune response.
5. Viral vector-based cancer vaccines: In this approach, a harmless virus is modified to carry genetic material encoding cancer antigens. When introduced into the body, the virus infects cells, causing them to produce the cancer antigen and stimulating an immune response.

While some cancer vaccines have shown promising results in clinical trials, none have yet been approved for widespread use by regulatory authorities such as the US Food and Drug Administration (FDA). Researchers continue to explore and refine various vaccine strategies to improve their efficacy and safety.

Animal welfare is a concept that refers to the state of an animal's physical and mental health, comfort, and ability to express normal behaviors. It encompasses factors such as proper nutrition, housing, handling, care, treatment, and protection from harm and distress. The goal of animal welfare is to ensure that animals are treated with respect and consideration, and that their needs and interests are met in a responsible and ethical manner.

The concept of animal welfare is based on the recognition that animals are sentient beings capable of experiencing pain, suffering, and emotions, and that they have intrinsic value beyond their usefulness to humans. It is guided by principles such as the "Five Freedoms," which include freedom from hunger and thirst, freedom from discomfort, freedom from pain, injury or disease, freedom to express normal behavior, and freedom from fear and distress.

Animal welfare is an important consideration in various fields, including agriculture, research, conservation, entertainment, and companionship. It involves a multidisciplinary approach that draws on knowledge from biology, ethology, veterinary medicine, psychology, philosophy, and law. Ultimately, animal welfare aims to promote the humane treatment of animals and to ensure their well-being in all aspects of their lives.

Cooperative behavior, in a medical or healthcare context, refers to the actions and attitudes displayed by individuals or groups working together to achieve a common goal related to health and well-being. This may involve patients following their healthcare providers' advice, healthcare professionals collaborating to diagnose and treat medical conditions, or communities coming together to promote healthy behaviors and environments. Cooperative behavior is essential for positive health outcomes, as it fosters trust, communication, and shared decision-making between patients and healthcare providers, and helps to ensure that everyone involved in the care process is working towards the same goal.

Peer review is a process in which experts in a field assess the quality and validity of scientific research, scholarly articles, or other professional works prior to publication. In the context of medical research, peer review typically involves one or more researchers with similar expertise evaluating a manuscript or study proposal to ensure that it meets established standards for design, methodology, analysis, and interpretation of results. The goal of peer review is to maintain the integrity and credibility of the scientific record by identifying and correcting errors, biases, or other shortcomings in the research before it is published. Peer review is a standard practice in medical publishing and is considered an essential component of the scientific process.

Cancer care facilities are healthcare institutions that provide medical and supportive services to patients diagnosed with cancer. These facilities offer a range of treatments, including surgery, radiation therapy, chemotherapy, immunotherapy, and hormone therapy. They also provide diagnostic services, pain management, rehabilitation, palliative care, and psychosocial support to help patients cope with the physical and emotional challenges of cancer and its treatment.

Cancer care facilities can vary in size and scope, from large academic medical centers that offer cutting-edge clinical trials and specialized treatments, to community hospitals and outpatient clinics that provide more routine cancer care. Some cancer care facilities specialize in specific types of cancer or treatments, while others offer a comprehensive range of services for all types of cancer.

In addition to medical treatment, cancer care facilities may also provide complementary therapies such as acupuncture, massage, and yoga to help patients manage symptoms and improve their quality of life during and after treatment. They may also offer support groups, counseling, and other resources to help patients and their families cope with the challenges of cancer.

Overall, cancer care facilities play a critical role in diagnosing, treating, and supporting patients with cancer, helping them to achieve the best possible outcomes and quality of life.

Statistics, as a topic in the context of medicine and healthcare, refers to the scientific discipline that involves the collection, analysis, interpretation, and presentation of numerical data or quantifiable data in a meaningful and organized manner. It employs mathematical theories and models to draw conclusions, make predictions, and support evidence-based decision-making in various areas of medical research and practice.

Some key concepts and methods in medical statistics include:

1. Descriptive Statistics: Summarizing and visualizing data through measures of central tendency (mean, median, mode) and dispersion (range, variance, standard deviation).
2. Inferential Statistics: Drawing conclusions about a population based on a sample using hypothesis testing, confidence intervals, and statistical modeling.
3. Probability Theory: Quantifying the likelihood of events or outcomes in medical scenarios, such as diagnostic tests' sensitivity and specificity.
4. Study Designs: Planning and implementing various research study designs, including randomized controlled trials (RCTs), cohort studies, case-control studies, and cross-sectional surveys.
5. Sampling Methods: Selecting a representative sample from a population to ensure the validity and generalizability of research findings.
6. Multivariate Analysis: Examining the relationships between multiple variables simultaneously using techniques like regression analysis, factor analysis, or cluster analysis.
7. Survival Analysis: Analyzing time-to-event data, such as survival rates in clinical trials or disease progression.
8. Meta-Analysis: Systematically synthesizing and summarizing the results of multiple studies to provide a comprehensive understanding of a research question.
9. Biostatistics: A subfield of statistics that focuses on applying statistical methods to biological data, including medical research.
10. Epidemiology: The study of disease patterns in populations, which often relies on statistical methods for data analysis and interpretation.

Medical statistics is essential for evidence-based medicine, clinical decision-making, public health policy, and healthcare management. It helps researchers and practitioners evaluate the effectiveness and safety of medical interventions, assess risk factors and outcomes associated with diseases or treatments, and monitor trends in population health.

I'm sorry for any confusion, but "Japan" is not a medical term. Japan is the name of a country, officially known as Nippon-koku or Nihon-koku in Japanese, and is located in East Asia. It is an island nation in the Pacific Ocean with a population of about 126 million people.

If you have any medical questions or terms that you would like me to define, please let me know!

The Chi-square distribution is a continuous probability distribution that is often used in statistical hypothesis testing. It is the distribution of a sum of squares of k independent standard normal random variables. The resulting quantity follows a chi-square distribution with k degrees of freedom, denoted as χ²(k).

The probability density function (pdf) of the Chi-square distribution with k degrees of freedom is given by:

f(x; k) = (1/ (2^(k/2) * Γ(k/2))) \* x^((k/2)-1) \* e^(-x/2), for x > 0 and 0, otherwise.

Where Γ(k/2) is the gamma function evaluated at k/2. The mean and variance of a Chi-square distribution with k degrees of freedom are k and 2k, respectively.

The Chi-square distribution has various applications in statistical inference, including testing goodness-of-fit, homogeneity of variances, and independence in contingency tables.

Patient rights refer to the ethical principles, legal regulations, and professional guidelines that protect and ensure the autonomy, dignity, and well-being of patients during healthcare encounters. These rights encompass various aspects of patient care, including informed consent, privacy, confidentiality, access to medical records, freedom from abuse and discrimination, pain management, and communication with healthcare providers.

The specific components of patient rights may vary depending on the jurisdiction and legal framework but generally include:

1. Right to receive information: Patients have the right to obtain accurate, clear, and comprehensive information about their health status, diagnosis, treatment options, benefits, risks, and prognosis in a manner they can understand. This includes the right to ask questions and seek clarification.
2. Informed consent: Patients have the right to make informed decisions about their care based on complete and accurate information. They must be given sufficient time and support to consider their options and provide voluntary, informed consent before any treatment or procedure is performed.
3. Privacy and confidentiality: Patients have the right to privacy during medical examinations and treatments. Healthcare providers must protect patients' personal and medical information from unauthorized access, disclosure, or use.
4. Access to medical records: Patients have the right to access their medical records and obtain copies of them in a timely manner. They can also request amendments to their records if they believe there are errors or inaccuracies.
5. Freedom from discrimination: Patients have the right to receive care without discrimination based on race, ethnicity, national origin, religion, sex, sexual orientation, gender identity, age, disability, or socioeconomic status.
6. Pain management: Patients have the right to appropriate pain assessment and management, including access to palliative and hospice care when appropriate.
7. Refusal of treatment: Patients have the right to refuse any treatment or procedure, even if it may be life-saving, as long as they are competent to make that decision and understand the consequences.
8. Communication and language assistance: Patients have the right to clear, effective communication with their healthcare providers, including access to interpreters or other necessary language assistance services.
9. Respect and dignity: Patients have the right to be treated with respect, dignity, and consideration during all aspects of their care.
10. Complaint resolution: Patients have the right to voice concerns about their care and receive timely responses from healthcare providers or institutions. They also have the right to file complaints with regulatory bodies if necessary.

"Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (PDF). Food and ... "Data Monitoring Committees in Practice: Tips on using DMCs to improve trial efficiency and safety". Applied Clinical Trials. ... A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of ... Data and Safety Monitoring Committees in Clinical Trials, Chapman & Hall/CRC, ISBN 978-1-4200-7037-8 David Kerr; Lynn Shemanski ...
Large, multi-site clinical trials are commonly overseen by a Data Monitoring Committee or Data and Safety Monitoring Board ( ... Ellenberg, Susan Smith.; Fleming, Thomas R.; DeMets, David L. (2002). Data monitoring committees in clinical trials : a ... In addition, an ISO has experience with clinical trials so that they can monitor the progress of the trial for adequate ... For clinical trials with intermediate complexity or risk, the use of an ISO can be very helpful to monitor the trial for ...
Reviews of Data Monitoring Committees in Clinical Trials: A Practical Perspective: Levin, Bruce (January-February 2003), "No, ... With Thomas Fleming and David DeMets, Ellenberg is the author of Data Monitoring Committees in Clinical Trials: A Practical ... for leadership in setting standards for clinical trial data monitoring committees; for senior statistical leadership for many ... She was the 1993 president of the Society for Clinical Trials and the 1999 President of the Eastern North American Region of ...
... of Clinical Trial Data Monitoring Committees EMA/CHMP/295050/2013 Adjustment for baseline covariates in clinical trials CHMP/ ... or Data and Safety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. EMA/CHMP/ ... CHMP/EWP/5872/03: Data monitoring committees (EMA) deals with independent data monitoring committees. It highlights the key ... FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees. This guidance discusses the roles, ...
"Coronado Biosciences Announces Independent Data Monitoring Committee Recommendation to Discontinue Falk Phase 2 Trial of TSO in ... Early clinical trials suggested that exposure to helminths such as Trichuris suis or Necator americanus can improve IBD. ... Early trials of Trichuris suis ova (TSO) showed promising results when used in people with IBD but later trials failed at Phase ... However, the phase 2 trials had used a different formulation of TSO from the one that had been used in the earlier studies that ...
... gives a p-value threshold for each interim analysis which guides the data monitoring committee on whether to stop the trial. ... The Pocock boundary is a method for determining whether to stop a clinical trial prematurely. The typical clinical trial ... The investigators running the clinical trial will wish to stop the trial early for ethical reasons if the treatment group ... The many reasons underlying when to stop a clinical trial for benefit were discussed in his editorial from 2005. The Pocock ...
He has served on numerous data and safety monitoring committees for clinical trials, both those sponsored by the National ... Trial. He has chaired five randomized, controlled, clinical trials on the treatment of CMV retinitis and now chairs a ... "Eyecare Clinical Trials". Archived from the original on 2010-02-12. Retrieved 2010-04-28. "Multicenter Uveitis Steroid ... Jabs DA, Nussenblatt RB, Rosenbaum JT (September 2005). "Standardization of uveitis nomenclature for reporting clinical data. ...
In addition he has served as chair of the Data Monitor Committee for numerous phase III trials, including 6 trials pivotal for ... His research has mainly focused on translational science and clinical research trials of advanced prostate cancer since 1990 ... He has published extensively on both prostate cancer translational studies and clinical trials that involve novel agents. ... A Randomized Phase III Trial-FIRSTANA". Journal of Clinical Oncology. 35 (28): 3189-3197. doi:10.1200/JCO.2016.72.1068. ISSN ...
In larger clinical trials, a sponsor will use the services of a data monitoring committee (DMC, known in the US as a data ... Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in ... Adaptive clinical trials use existing data to design the trial, and then use interim results to modify the trial as it proceeds ... Web-based electronic data capture (EDC) and clinical data management systems are used in a majority of clinical trials to ...
Tokai announced the discontinuation of ARMOR3-SV on July 26, 2016, after a data monitoring committee determined that the trial ... Clinical trial number NCT02438007 for "A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor ... Galeterone was being compared to enzalutamide in a phase III clinical trial (ARMOR3-SV) for AR-V7-expressing metastatic ... "Lowe inks new deal for clinical trials of another cancer drug". Stock Gitter. "Educational & Scientific, LLC and University of ...
... data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the ... Data and Safety Monitoring Board or Independent Data Monitoring Committee DSMB. An impartial group that oversees a clinical ... The terms clinical trial and clinical study are synonymous. (ICH E6) Clinical Trial/Study Report A written description of a ... Also called a clinical trial. (NCI) A clinical trial is a research study to answer specific questions about vaccines or new ...
Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy". Veru Inc. (Press release). 11 April 2022. ... "Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients". ... "Veru Announces Oral Late-Breaking Presentation of Phase 2 Data of Sabizabulin for the Treatment of Hospitalized Severe COVID-19 ... ClinicalTrials.gov (Press release). 13 April 2021. Retrieved 1 May 2022. Li, Chien-Ming; Lu, Yan; Chen, Jianjun; Costello, ...
"External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE ... pilot trial". Contemporary Clinical Trials Communications. 2017, 5: 1-7. doi:10.1016/j.conctc.2017.01.006. PMC 5389338. PMID ... "Home Affairs Committee - Drugs: Breaking the CycleWritten evidence submitted by Sheila M Bird OBE MA PhD CStat FFPH, Medical ... Parmar MK, Strang J, Choo L, Meade AM, Bird SM (2016). "Randomized controlled pilot trial of naloxone-on-release to prevent ...
... regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco- ... The FDA has focused its concern on study results from some clinical trials showing an increased risk of death and tumor growth ... Psychiatric diseases Randomized clinical control trials have shown promising results of EPO in improving cognition which is ... In a randomized controlled trial, erythropoietin was shown to not change the number of blood transfusions required by ...
He served on several data monitoring committees of major clinical trials, including Gusto, ECLA, ASCOT, ADVANCE, EUCLID, MODEST ... as chair of the ISIS group steering committee and the related coronary prevention studies coordinated by the Clinical Trials ... Clinical & Experimental Physiology & Pharmacology, and the Journal of Ambulatory Monitoring. He peer reviewed articles and co- ... As chair of the ISIS group steering committee he was involved in several significant international trials in cardiology, such ...
Its moral reflection has been enriched and tested by the experience of various Data and Safety Monitoring Committees ( ... overseeing clinical trials in AIDS or cancer patients) and by participation (1990-1998) in the work of the National ... clinical research methodology, ethics of bio-medical investigation, biological epistemology, bio-medical anthropology. Her ... and was developed through fruitful contacts with clinical and epidemiological research. ...
Consortium Clinical trials registry Community-based clinical trial Contract Research Organization Data Monitoring Committees ... Academic clinical trials Bioethics CIOMS Guidelines Clinical data acquisition Clinical Data Interchange Standards ... "AIDS Clinical Trials and Information Services What is AIDS AIDS Symptoms and Treatments AIDS Research Aids Clinical Trials". ... Each trial record is administered by a trial record manager. A trial record manager typically provides initial trial ...
... consent Data Monitoring Committees Office for human research protections Ethical problems using children in clinical trials ... Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit ... The first REC service was established at the National Institutes of Health (NIH) Clinical Center in 1997. Today, most REC ... Institutional Review Board Ethics Committee (European Union) Human experimentation in the United States IRB: Ethics & Human ...
... as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional ... According to the 2010 update to clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the ... November 2010). "American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the ... Amgen sent a "dear stockholders" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and ...
Philippines Data monitoring committee for a clinical trial Detailed marks certificate, a detailed report of academic ... Data Matrix Code, laser etched square code, often used for marking products in the production area Diffusion Monte Carlo method ... performance Digital Media City, Seoul, South Korea Disaster Monitoring Constellation of imaging satellites DMC International ...
Adverse event, including mild/minor Clinical trial Good clinical practice (GCP) Data Monitoring Committees Pharmacovigilance ... a drug that had SAEs in a clinical trial BIA 10-2474, a drug that had SAEs, including a fatality, in a clinical trial What Is A ... Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that ... To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. Serious ...
... data received by the FDA. Clinical trial Complication (medicine) Good clinical practice (GCP) Data monitoring committees ... influences the extent and nature of data. A 2018 review conducted found that some participants in clinical drug trials were ... "Eliciting adverse effects data from participants in clinical trials". The Cochrane Database of Systematic Reviews. 1 (1): ... Clinical trial results often report the number of grade 3 and grade 4 adverse events. Grades are defined: Grade 1 Mild AE Grade ...
Clinical trials Data monitoring committee Drug development European Medicines Agency Safety monitoring U.S. Food and Drug ... Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Monitors may be ... monitor, Clinical Research Monitor, Study Site Monitor and Quality Specialist. The number of clinical monitors depends on the ... of clinical trial monitoring is to observe each trial site to ensure that the standardized operation procedures for the trial ...
Clinical trial Data monitoring committee Declaration of Helsinki Ethical problems using children in clinical trials Ethics ... Such studies may be clinical trials of new drugs or medical devices, studies of personal or social behavior, opinions or ... Here is a summary of several key regulatory guidelines for oversight of clinical trials: Safeguard the rights, safety, and well ... A 2016 article on the hope to expand ethics reviews of such research included an example of a data breach in which a big data ...
... means of communicating a clinical trial's interim analysis results and recommendations between the Data Monitoring Committee ( ... Cytel specializes in adaptive trials - a type of randomized clinical trial that allows modifications of ongoing trials while ... Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and ... Compass Compass is used by biostatisticians and clinicians to plan and design earlier stage adaptive clinical trials ( ...
... and the Data Safety Monitoring Board for the Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension for ... Current federal appointments include the U.S Food and Drug Administration's Cardiovascular and Renal Advisory Committee, ... He was a clinical and research fellow in peripheral vascular disease at the Evans Memorial Foundation for Clinical Research in ... Halperin, Jonathan L (August 2009). "What can ongoing clinical trials of anticoagulants demonstrate?". Journal of ...
Data monitoring committees Directive 2001/20/EC (European Union) Drug development EudraVigilance European Forum for Good ... clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. A ... health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en Commissioner, Office of the. " ... "Clinical Trials and Human Subject Protection". www.fda.gov. Retrieved 2018-11-01. "Good Clinical Practice Training , grants.nih ...
However, the trial was terminated in February 2018, after a data monitoring committee concluded it was unlikely that the drug ... it was in two phase 2/3 clinical trials that have progressed to phase 3. EPOCH, was to complete data collection for the primary ... www.firstwordpharma.com/node/1542930 Clinical trial number NCT01953601 for "Efficacy and Safety Trial of Verubecestat (MK-8931 ... "Merck presents results of a phase I clinical trial evaluating investigational BACE inhibitor MK-8931 at American Academy of ...
... clinical trials data monitoring committees MeSH N05.700.685.300 - ethics committees MeSH N05.700.685.300.500 - clinical ethics ... clinical trials MeSH N05.715.360.775.235.200 - phase i clinical trials MeSH N05.715.360.775.235.210 - phase ii clinical trials ... phase iii clinical trials MeSH N05.715.360.775.235.230 - phase iv clinical trials MeSH N05.715.360.775.235.387 - controlled ... ethics committees MeSH N05.350.268.500 - clinical ethics committees MeSH N05.350.268.750 - ethics committees, research MeSH ...
... the Biomedical Ethics Advisory Committee, and several Data and Safety Monitoring Boards for NIH clinical trials. From 1996 to ... the UNOS Ethics Committee, the Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, ...
This trial was terminated in February 2022, on the advice of an external Data Monitoring Committee, on an account of an excess ... RENOIR)" at ClinicalTrials.gov Clinical trial number NCT04424316 for "A Trial to Evaluate the Efficacy and Safety of RSVpreF in ... at ClinicalTrials.gov Clinical trial number NCT04841577 for "A Study on the Immune Response and Safety Elicited by a Vaccine ... at ClinicalTrials.gov Clinical trial number NCT05035212 for "Study to Evaluate the Efficacy, Immunogenicity, and Safety of ...
"Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (PDF). Food and ... "Data Monitoring Committees in Practice: Tips on using DMCs to improve trial efficiency and safety". Applied Clinical Trials. ... A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of ... Data and Safety Monitoring Committees in Clinical Trials, Chapman & Hall/CRC, ISBN 978-1-4200-7037-8 David Kerr; Lynn Shemanski ...
keywords = "Clinical trials, Data Monitoring Committees, Data safety monitoring board, Clinical trials as topic, Cardiovascular ... N2 - Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study ... AB - Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study ... Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study ...
Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and ... Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and ... Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice) By: Susan S. Ellenberg (Author ... Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing ...
Cardiovascular Clinical Trials: Putting the Evidence into Practice - Author: Bhatt, Deepak (#editor) - Price: 77,10€ ... Data Monitoring Committees in Clinical Trials: A Practical Perspective. DeMets, David L. ... Keywords: clinical trials; designing cardiovascular clinical trials; conducting cardiovascular clinical trials; statistical ... Methods and Applications of Statistics in Clinical Trials: Volume 1 - Concepts, Principles, Trials, and Designs. Balakrishnan, ...
The DSMC has reviewed the safety and pharmacokinetic data from Cohort 1 and recommended that the study may proceed to enroll p ... About the Phase 1b/2a Clinical Trial. The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is ... Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical ... Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee that ...
Join this webinar to learn more about incorporating microsampling into a clinical trial and evaluating the performance of ... Data Monitoring Committees in the Changing Landscape of Clinical Trials. April 29, 2021 Decentralized Clinical Trials: Lets ... The Promise of Microsampling in Supporting Remote Clinical Trials. Life Sciences, Clinical Trials, Pharmaceutical, Laboratory ... How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation. ...
We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who ... Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly ... UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common ... International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014. ...
Doll R (2002). The role of data monitoring committees. In: Duley L, Farrell B, eds. Clinical Trials. London: BMJ Books, p 97- ... Chalmers I, Dukan E, Podolsky SH, Davey Smith G (2011). The advent of fair treatment allocation schedules in clinical trials ... To avoid being parochial, research into this important era in the evolution of clinical trials requires knowledge in several ... Bryder L (2010). The Medical Research Council and clinical trial methodologies before the 1940s: the failure to develop a ...
... clinical trial. National Institutes of Health. NET PD studies. Independent clinical monitor. Neurogen 2009 data safety monitor ... committee chair. EM: received honorarium from Medtronics. AS: governmental organisation grant. SF: scientific advisory board ... Merck Serono clinical trial, site PI. AL: consultant for research projects, drug development, etc. Abbott, Allon Therapeutics, ... Prevalence and clinical features of hedonistic homeostatic dysregulation in Parkinsons disease. Mov Disord 2005;20:77-81. ...
Data monitoring and ethics committees. *Trial steering groups. *Dissemination meetings. Another important consideration when ... Clinical trials training as part of an NIHR Research Training Award. Anyone proposing to include a clinical trial as part of a ... The list is intended to cover all aspects of clinical trials that future health research leaders competent in clinical trials ... Is a new trial in a different target population justified?. A common type of proposal is to evaluate (through a trial or trial ...
Blood and Marrow Transplantation Clinical Trials Network (BMT-CTN), National * Data Monitoring Committee, CARTITUDE-2 and ... Data Safety and Monitoring Board, Multiple Myeloma Research Consortium (MMRC)-089 trial, "A Phase I/II Assessment of ... Independent Data Monitoring Committee, Belantamab Mafodotin Phase 3 Program, GlaxoSmithKline, International * International ... A review of current data and potential clinical applications American Journal of Hematology 94 (S1): S28-S33,2019. ...
A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is ... The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j. ... The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded ... design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a ...
Thus, the Data and Safety Monitoring Committee recommended that the study be terminated. In the updated analyses, median OS and ... This multicenter trial included esophageal cancer patients with clinical T4 disease and/or unresectable regional lymph node ... This study was registered at the UMIN Clinical Trials Registry as UMIN000000861. ...
Advanced and Cellular Therapy Trial Management Team, which is part of the Cancer Research UK Clinical Trials Unit (CRCTU) based ... The CATALYST Trial is coordinated by the Inflammation - ... The Data Monitoring Committee (DMC) is a group of independent ... Miss Camilla Bathurst, Trial Coordinator, CRCTU, University of Birmingham. *Karen James, Clinical Trial Monitor, CRCTU, ... Professor Simon Gates, Professor of Biostatistics and Clinical Trials, Cancer Research UK Clinical Trials Unit (CRCTU), ...
Trial has a data monitoring committee. No E.8.8. Definition of the end of the trial and justification where it is not the last ... Clinical Trials Information System (CTIS). The EU Clinical Trials Register currently displays 43692 clinical trials with a ... Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: * ... EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly ...
Trial has a data monitoring committee. No E.8.8. Definition of the end of the trial and justification where it is not the last ... Clinical Trials Information System (CTIS). The EU Clinical Trials Register currently displays 43724 clinical trials with a ... Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: * ... EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly ...
Eisais news release CARDIOVASCULAR OUTCOMES TRIAL OF ANTI-OBESITY AGENT LORCASERIN TO CONTINUE BASED ON RECOMMENDATION OF ... INDEPENDENT DATA MONITORING COMMITTEE AFTER COMPLETION OF INTERIM SAFETY ANALYSIS is posted. ... This Phase â…¢b/IV clinical study, comprised of 12,000 patients, is being conducted over a 5-year period in partnership with the ... OUTCOMES TRIAL OF ANTI-OBESITY AGENT LORCASERIN TO CONTINUE BASED ON RECOMMENDATION OF INDEPENDENT DATA MONITORING COMMITTEE ...
When the independent data monitoring committee and the regulatory authorities agreed to continuation of the study (clinical ... Clinical Programming Lead]); Clinical Working Group members (Sanne de Ridder [Clinical Trial Manager], Len Roza [ID&V Risk ... An independent data monitoring committee was established to assess the safety data regularly during the study. The study was ... EUCLID/F-CRIN Clinical Trials Platform (Christine Schwimmer, PhD [EUCLID Executive Director], Christine Betard [Clinical Trial ...
Has Data Monitoring Committee Yes U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No. ... The proposed study aims to evaluate in a randomized controlled trial the efficacy of DBT + pharmacotherapy as compared with ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ...
An independent Data Monitoring Committee has reviewed data from MAPS ongoing Phase 3 clinical trial ... The analysis was conducted by an independent Data Monitoring Committee, which reviewed the results from the first 60 out of 100 ... announced the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted ... MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of ...
Data monitoring committees serve the same kind of purpose, but are made up mostly of scientists. A data monitoring committee ... Accessing Clinical Trials. Clinical trials arent just for people with metastatic cancers, though many people believe thats ... Boards and Committees for Protection. One way participant safety during trials is monitored is through institutional review ... Food and Drug Administration may grant approval for it to be used outside of trials. The FDA monitors trials and must give ...
Phase III data for Pfizers respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and ... forced to suspend three maternal clinical trials after a routine safety assessment by an Independent Data Monitoring Committee ... These data represent strong progress in the development of RSV vaccines. Still, more work and additional data are needed, Ruth ... Infant Trial Hits One of Two Endpoints. The second NEJM paper looked at the protective potential of Pfizers vaccine candidate ...
... and relevant staff within the clinical trials unit. An Independent Data Monitoring Committee may also be established to oversee ... "Clinical trials are very closely monitored by a number of different individuals and organisations. This will include the Chief ... I understand that before 2008 the responsibility for collecting and sharing data for clinical trials and for standard ... Much of that has been due to the use of standardised protocols in clinical trials and specialisation of care, as evidenced in ...
Data Monitoring Committee Recommends Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Heart Failure Continue ... The DMC reviewed data from GALACTIC-HF and recommended that this Phase 3 clinical trial of omecamtiv mecarbil continue without ... today announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned ... Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial ...
More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have ... Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional ... This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding ... This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 ...
Merck halts a late-stage trial of verubecestat, which targeted an enzyme involved in brain plaque formation   ... But an independent data monitoring committee determined that there was virtually no chance of finding a positive clinical ... Blinded clinical trials use independent monitors to watch for any unexpected safety problems that may crop up. They can also ... Reuters) - Merck & Co Inc said on Tuesday it will halt a late-stage trial of an Alzheimers drug after it was determined that ...
TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. TJ is ... The inclusion of a large quantity of data (we propose that authors justify whether the quantity of data they report can be ... Systematic inclusion of data from several different sources: primary data, literature (published/grey), regulatory, or registry ... considered large). This, for example, could include clinical study reports (CSRs) as a source of data. CSRs are large and ...
... and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node ... Therefore decreasing the variability, especially in a multicenter clinical trial setting, ... and present a framework for prospective clinical trials and practice. ... The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with ...
Want to learn more about The Evolution of Clinical Trials? Click the above link for complete detail on the same. Read now! ... Committees in Clinical Trials and instructor for the course Independent Data Monitoring Committees in Clinical Trials here at ... the industry itself has created independent Data and Safety Monitoring Committees (DMCs) to oversee clinical trials. In the ... Arun Blatts 2010 article in Perspectives in Clinical Research recounts other early precursors to the modern clinical trial, ...
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis. (therivabio.com)
  • In this randomised, observer-blind, placebo-controlled Phase II trial, 668 healthy 18- to 70-year-olds and 142 HIV-infected 18- to 50-year-olds were enrolled from 1 site in Kenya and 2 sites each in Burkina Faso, Cote d'Ivoire, and Uganda. (plos.org)
  • Trials are placebo-controlled. (alz.org)
  • Trials may be separated into two main types: interventional or observational. (britannica.com)
  • Interventional trials assign participants to a procedure or treatment and then measure the effects of that intervention. (britannica.com)
  • Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. (uea.ac.uk)
  • Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. (who.int)
  • Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. (who.int)
  • Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. (springer.com)
  • From searching the Health Technology Assessment (HTA) website and the ISRCTN register, there was no large-scale, multi-centre, randomised controlled trial (RCT) of interventions for primary frozen shoulder being undertaken. (springer.com)
  • The aim of our research is to provide evidence of clinical and cost-effectiveness for commonly used interventions in the National Health Service (NHS) for the management of frozen shoulder in secondary care. (springer.com)
  • The Data Monitoring Committee (DMC) is a group of independent professionals, whose role is to review accruing data to assess the safety and efficacy of the interventions, and monitor the overall conduct of the trial. (birmingham.ac.uk)
  • We identified an excellent series of articles under the banner "Considering Complexity in Systematic Reviews of Interventions" in the Journal of Clinical Epidemiology , although we were unable to identify an explicit definition of a complex review. (bmj.com)
  • Lastly, we identified a paper by Whitlock and colleagues , who describe a complex review as one that "evaluate(s) a number of linked clinical questions, multiple interventions or diagnostic tests, different or distinct population groups, and/or many outcomes. (bmj.com)
  • Clinical trials test new interventions or drugs in a series of steps (or phases) to prevent, detect or treat disease. (alz.org)
  • Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines , drugs , dietary choices , dietary supplements , and medical devices ) and known interventions that warrant further study and comparison. (wikipedia.org)
  • Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. (wikipedia.org)
  • Also, current and potential trial participants could be freed to take other treatments, rather than this experimental treatment, which is unlikely to benefit them. (wikipedia.org)
  • The trial is expected to enroll up to 36 participants with three sequential cohorts, each evaluating a different study-assigned IV beta-lactam antibiotic. (therivabio.com)
  • The analysis was conducted by an independent Data Monitoring Committee, which reviewed the results from the first 60 out of 100 participants. (maps.org)
  • The analysis revealed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated, and that the trial will not require additional participants beyond the first 100. (maps.org)
  • As a non-profit organization focused on mental health services, MAPS is committed to protecting the safety of its study staff and clinical trial participants. (maps.org)
  • As a result of this initiative, new enrollment of participants in MAPS-sponsored trials is temporarily postponed, with treatments continuing for some participants as evaluated on a case-by-case basis. (maps.org)
  • Phase III clinical trials are usually randomized , which means a computer assigns participants to each treatment group. (lbbc.org)
  • Participants already enrolled in the trials will continue to receive the study medicine. (merck.com)
  • Informed by the recommendations of the PrEP eDMC, Merck is implementing additional monitoring measures for study participants, including increasing the frequency of total lymphocyte and CD4+ T-cell assessments. (merck.com)
  • Although participants and study staff don't know who's getting the treatment and who's getting the placebo, most trials have a separate, independent Data Safety and Monitoring Committee that has access to this information. (alz.org)
  • The FDA's hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies. (medscape.com)
  • In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. (medscape.com)
  • We are grateful to the participants and the study investigators for their ongoing contributions to this research," Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. (medscape.com)
  • Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck's press release. (medscape.com)
  • Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. (medscape.com)
  • To conduct a clinical trial, researchers must first develop a study plan, or protocol , in which they describe the study's aims, the characteristics of the participants, the scientific approach, the outcome measures, and the plan for statistical evaluation of the data. (britannica.com)
  • Observational trials collect a group of participants with a specific condition who receive a procedure or treatment as part of routine care and then measure the outcome results in this group. (britannica.com)
  • In both types of trials, the outcome in the participants undergoing the procedure or treatment is often compared with another group called the control. (britannica.com)
  • A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. (wikipedia.org)
  • citation needed] Also, there might be other reasons to continue, such as collecting more long-term safety data. (wikipedia.org)
  • Futility is not as widely recognized as safety and benefit, but actually can be the most common reason to stop a trial. (wikipedia.org)
  • The authoritative guide for Data Monitoring Committees--fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. (who.int)
  • Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study may proceed to enroll Cohort 2 in which study drug (SYN-004 or Placebo) will be administered in combination with the IV beta-lactam antibiotic piperacillin/tazobactam. (therivabio.com)
  • The trial is designed to evaluate the safety, tolerability, and potential absorption of oral SYN-004 (150 mg q.i.d. for a maximum of 28 days) into the systemic circulation of allogeneic HCT recipients who receive an IV antibiotic to treat fever. (therivabio.com)
  • Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee that will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic. (therivabio.com)
  • Thus, the Data and Safety Monitoring Committee recommended that the study be terminated. (nih.gov)
  • They ensure that the trial is performed in line with the high standards of Good Clinical Practice (GCP), most importantly focusing on the safety and well-being of the patients involved. (birmingham.ac.uk)
  • Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") has announced that it has received a recommendation from an independent Data Monitoring Committee to continue the ongoing Cardiovascular Outcomes Trial (CAMELLIA-TIMI61 Study) of lorcaserin hydrochloride (U.S. brand name: BELVIQ®, "lorcaserin") after the completion of a pre-specified interim safety analysis, evaluating the incidence of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, myocardial infarction or stroke. (eisai.com)
  • This Phase â…¢b/IV clinical study, comprised of 12,000 patients, is being conducted over a 5-year period in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is intended to address the post-marketing requirement from the U.S. Food and Drug Administration to evaluate the long-term cardiovascular safety of lorcaserin. (eisai.com)
  • We conducted a randomised trial to assess the safety and the immunogenicity of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in 3 different vaccination intervals in healthy and HIV-infected adults. (plos.org)
  • One way participant safety during trials is monitored is through institutional review boards , IRBs, teams of doctors, experts, researchers and sometimes community members, who decide whether a trial is safe. (lbbc.org)
  • Voting 7-4 for Pfizer and 10-2 for GSK, the panel of external experts recommended the approval of both candidates, citing good safety and efficacy data. (biospace.com)
  • In February 2022, GSK was forced to suspend three maternal clinical trials after a routine safety assessment by an Independent Data Monitoring Committee. (biospace.com)
  • Blinded clinical trials use independent monitors to watch for any unexpected safety problems that may crop up. (scientificamerican.com)
  • Instead, since the 1980's, the industry itself has created i ndependent Data and Safety Monitoring Committees (DMC's) to oversee clinical trials. (statistics.com)
  • He is actively involved in the design and execution of many acute and chronic heart failure clinical trials, serving on endpoint, data safety monitoring, and steering committees for numerous international studies investigating a variety of new therapies. (biospace.com)
  • He serves as a consultant on clinical development programs in multiple areas of cardiology, as well as in cardiovascular safety for non-cardiovascular indications. (biospace.com)
  • A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. (lupustrials.org)
  • The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection. (merck.com)
  • During this phase, researchers continue to monitor the health of people taking the medication to gain further insight into its long-term safety and effectiveness. (alz.org)
  • Clinical trials generate data on dosage, safety and efficacy. (wikipedia.org)
  • The Independent Data and Safety Monitoring Committee requested reporting of the results after there were 458 (95%) of a target of 480 deaths. (lu.se)
  • The lack of thorough testing in animals prior to clinical trials, and authorization based on safety data generated during trials that lasted less than 3.5 months, raise questions regarding vaccine safety. (researchgate.net)
  • As for any investigational biomedical program, data safety monitoring boards (DSMB) and event adjudication committees (EAC), should be enacting risk mitigation. (researchgate.net)
  • Ideally, before new drugs and other treatments, diagnostic tests, or preventive measures are accepted for general use, they should be studied in clinical trials to determine whether they have advantages over existing methods in health benefits, safety, or cost. (britannica.com)
  • Does the trial have a data safety monitoring committee? (who.int)
  • This will be the first time GSK will publicly present efficacy and safety data from their phase III trial. (cdc.gov)
  • we also demonstrated the safety and efficacy of this cell therapy in an earlier phase I/II clinical trial conducted on seven patients with fracture nonunion. (bvsalud.org)
  • The safety of this product is evaluated through the China and international clinical trials. (who.int)
  • The China Phase / clinical trials are randomized, double-blinded and placebo parallel controlled to preliminarily evaluate the safety and immunogenicity of this product for adults 18 years and older. (who.int)
  • The international Phase clinical trial is an international multi-center, randomized, double-blinded, placebo parallel controlled to evaluate the protective efficacy, safety and immunogenicity of this product. (who.int)
  • Investigators actively follow up the safety data of 0~21/28 days after each vaccination to observe the occurrence of adverse events, and pay attention to the serious adverse events occurred within 12 months after full-course vaccination at the same time. (who.int)
  • Identify clinical implications of safety and efficacy of Omr-IgG-am compared with that of IVIG and NS in patients with WNV neuroinvasive disease in a phase 2, randomized, double-blind, multicenter study. (cdc.gov)
  • So I'm going to briefly cover some of our monitoring systems and then I'll spend a little time on vaccine safety and pregnancy. (cdc.gov)
  • It's a hypothesis generating or signal detection system designed to identify unusual or unexpected patterns, which might indicate a safety problem which can be further assessed in more robust data systems. (cdc.gov)
  • Flor Munoz disclose she receives a royalty for offering the Seasonal Influenza in Children chapter in UpToDate and is a member of the Data Safety Monitoring Board Pfizer, Moderna, and is a member of American pediatrics committee on infectious diseases. (cdc.gov)
  • If a feasibility study is a small randomised controlled trial, it need not have a primary outcome and the usual sort of power calculation is not normally undertaken. (nihr.ac.uk)
  • The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. (biomedcentral.com)
  • We are building up a broad data set showing FG001 is effective across a range of cancers and this, combined with its compatibility with different types of imaging equipment, means it has the potential to significantly improve the outcome of surgery for these patients, with tumors removed more precisely while leaving healthy tissue undamaged," says Morten Albrechtsen, CEO of FluoGuide. (nordiclifescience.org)
  • KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection. (merck.com)
  • The US Food and Drug Administration (FDA) has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug's developer, Merck and Co, announced in a press release . (medscape.com)
  • All staff working on a clinical trial of an investigational medicinal product (CTIMP) must read the University Policy for Compliance with The Medicines for Human Use. (manchester.ac.uk)
  • The trial is also designed to evaluate potential protective effects of SYN-004 on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allogeneic HCT recipients. (therivabio.com)
  • Join this webinar for a discussion of the ideal applications of microsampling in clinical research, including details on how to evaluate sample stability. (xtalks.com)
  • In fact, for half a century before the MRC trial and Fisher's writings, some medical practitioners wishing to evaluate the effects of treatments had used alternate allocation to assemble similar groups of patients, and so ensure that like would be compared with like. (jameslindlibrary.org)
  • A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. (biomedcentral.com)
  • The proposed study aims to evaluate in a randomized controlled trial the efficacy of DBT + pharmacotherapy as compared with CABS SOC psychotherapy + pharmacotherapy over 2 year followup among adolescents (age 12-18) with BP (n=100). (clinicaltrials.gov)
  • In the wake of the two ies in experimental animals in several independent press releases from ISCO it can be considered timely laboratories, many groups performed open label clin- to discuss how one should evaluate the opportunities ical trials in PD during the late 1980s and 1990s. (lu.se)
  • Lupus Therapeutics has an unprecedented network of clinical trial sites. (lupustrials.org)
  • NEW YORK, January 13, 2020 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinicalstage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, has entered into an agreement with Pfizer Inc. (NYSE: PFE) for an exclusive U.S. license to Pfizer's clinical and nonclinical data, and intellectual property for reboxetine, the active pharmaceutical ingredient in AXS-12 which Axsome is developing for the treatment of narcolepsy. (pfizer.com)
  • A futility analysis allowed the potential for stopping GALACTIC-HF early had the interim analysis shown a low likelihood of the trial demonstrating a clinically meaningful and statistically significant benefit on the primary endpoint in patients receiving omecamtiv mecarbil , plus standard of care , compared to patients receiving placebo plus standard of care. (amgen.com)
  • A superiority analysis allowed the potential for stopping the trial early if the primary composite endpoint and the secondary endpoint (time to cardiovascular death) reached statistical significance, adjusting the statistical threshold for interim review. (amgen.com)
  • From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease-the primary endpoint of many drug therapy trials in the neoadjuvant setting-is critical. (nature.com)
  • In 2012, the US Food and Drug Administration (FDA) released guidance indicating they would consider granting accelerated drug approval on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit. (nature.com)
  • As clinical trials involving neoadjuvant systemic therapy which include pathologic complete response as the primary endpoint increase, standardizing the surgical management in these trials is important in the face of evolving surgical techniques, in particular as it relates to the management of the axilla. (nature.com)
  • 2 Therefore, for clinical trials of novel agents in which pCR is the primary endpoint, these definitions-the absence of tumor in the breast as well as in the axillary lymph nodes-are the preferred definitions, reinforcing the importance of accurate assessment of axillary nodes for disease after neoadjuvant chemotherapy. (nature.com)
  • Genmab and Seagen have announced that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK, compared with chemotherapy alone, met its primary endpoint of overall survival (OS). (nordiclifescience.org)
  • Trials are "double-blinded. (alz.org)
  • The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals. (uea.ac.uk)
  • The detailed and exceptionally clear 1948 report of the British Medical Research Council's randomised trial of streptomycin for pulmonary tuberculosis is rightly regarded as a landmark in the history of clinical trials ( MRC 1948 ). (jameslindlibrary.org)
  • It should be noted that an underpowered 'exploratory trial' is not the same as a feasibility study and is unlikely to be funded as part of a research training award. (nihr.ac.uk)
  • Applicants need to consider the likelihood of other NIHR funding programmes or other funders being interested in supporting a full trial in the future when including a feasibility study in a research training award application. (nihr.ac.uk)
  • The feasibility study should also represent a high quality training vehicle for the applicant around clinical trials and research training more widely. (nihr.ac.uk)
  • The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). (biomedcentral.com)
  • The CATALYST Trial is coordinated by the Inflammation - Advanced and Cellular Therapy (I-ACT) Trial Management Team, which is part of the Cancer Research UK Clinical Trials Unit (CRCTU) based at the University of Birmingham. (birmingham.ac.uk)
  • The Trial Steering Committee (TSC) is a group of independent professionals, whose role is to provide overall supervision for the trial on behalf of the Trial Sponsor (University of Birmingham) and the Trial Funder (Cancer Research UK). (birmingham.ac.uk)
  • PLOS Medicine publishes research and commentary of general interest with clear implications for patient care, public policy or clinical research agendas. (plos.org)
  • Despite the popular belief that medical research in humans is unsafe or scary, some people find the structured care offered through clinical trials comforting. (lbbc.org)
  • Dr. Arun Blatt's 2010 article in Perspectives in Clinical Research recounts other early precursors to the modern clinical trial, including one documented in the Bible (book of Daniel). (statistics.com)
  • In 1946, the British Medical Research Council conducted a randomized clinical trial of the efficacy of streptomycinin the treatment of tuberculosis (TB). (statistics.com)
  • Dr. Teerlink completed his cardiovascular medicine fellowship and a Howard Hughes post-doctoral research fellowship at UCSF, subsequently joining the faculty, where he currently is a Professor of Clinical Medicine. (biospace.com)
  • The Lupus Clinical Investigators Network (LuCIN), is comprised of leading lupus experts at academic research centers throughout North America. (lupustrials.org)
  • We continue to apply learnings from our HIV program as we move forward with the development of islatravir in both treatment and PrEP," said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. (merck.com)
  • TrialMatch is a free clinical trials matching service that connects individuals with Alzheimer's, caregivers and healthy volunteers to current research studies. (alz.org)
  • In an interview with Medscape Medical News, Monica Gandhi, MD, MPH, director of University of California, San Francisco's Gladstone Center for AIDS Research, described the news of the islatravir trial holds as "very disappointing. (medscape.com)
  • Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers , in one country or in multiple countries. (wikipedia.org)
  • Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. (wikipedia.org)
  • and, as a Massachusetts General Hospital (MGH) employee, works with the MGH National Pregnancy Registry, which is sponsored by Teva, Alkermes, Otsuka, Actavis, and Sunovion, and works with the MGH Clinical Trials Network and Institute, which receives research funding from multiple pharmaceutical companies and the National Institute of Mental Health. (psychiatrist.com)
  • Here are the most current policies and guidance relating to data protection, the Human Tissue Act, clinical trials and animal research. (manchester.ac.uk)
  • If you are a member of research staff at The University of Manchester, read more about data protection on StaffNet . (manchester.ac.uk)
  • Find out more about insurance cover for research studies involving human subjects (clinical trials). (manchester.ac.uk)
  • The Lurie Cancer Center Clinical Trials Office (CTO) coordinates the majority of clinical research conducted in medical oncology, malignant hematology, gynecologic-oncology, neuro-oncology, radiation oncology, surgical oncology and chemoprevention. (northwestern.edu)
  • The aim of the Clinical Trial Center of the Rizzoli Orthopaedic Institute and Scientific Research Hospital (CTC.IOR) is to make research results and new therapies available as rapidly as possible, for the healthcare and wellbeing of patients suffering from musculo-skeletal diseases. (ior.it)
  • The CTC.IOR staff is continuously updated on the issues pertaining to clinical research, with the coordination of the Scientific Direction. (ior.it)
  • Recent news of an impending clinical cell transplantation trial in Parkinson's disease using parthenogenetic stem cells as a source of donor tissue have raised hopes in the patient community and sparked discussion in the research community. (lu.se)
  • and to advance measuring, monitoring and research for healthy ageing. (who.int)
  • Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. (wikipedia.org)
  • The company sponsoring the study could save money for other projects by abandoning this trial. (wikipedia.org)
  • UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. (springer.com)
  • The guidance below is aligned with the guidance provided to applicants for other NIHR programme funding and is intended to help applicants to NIHR personal awards think though the scope of any clinical trial, pilot study or feasibility study that is to be included within a personal award application. (nihr.ac.uk)
  • This study was registered at the UMIN Clinical Trials Registry as UMIN000000861. (nih.gov)
  • Study record managers: refer to the Data Element Definitions if submitting registration or results information. (clinicaltrials.gov)
  • One common fear is that in a randomized study a trial participant won't get the approved treatment for their cancer. (lbbc.org)
  • They can also recommend stopping a study early if it becomes clear that a drug is going to fail or if the data looks so compelling that it believes the treatment should be offered to those getting a placebo or other standard treatments. (scientificamerican.com)
  • This, for example, could include clinical study reports (CSRs) as a source of data. (bmj.com)
  • Phase III trials enroll several hundred to thousands of volunteers, often at multiple study sites worldwide. (alz.org)
  • Before joining a clinical trial, an individual must qualify for the study. (alz.org)
  • People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery. (medscape.com)
  • Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold. (medscape.com)
  • Clinical study design aims to ensure the scientific validity and reproducibility of the results. (wikipedia.org)
  • Data include measurements such as vital signs , concentration of the study drug in the blood or tissues, changes to symptoms, and whether improvement or worsening of the condition targeted by the study drug occurs. (wikipedia.org)
  • BioInvent International has received authorization to proceed from the Swedish Medical Product Agency for a new clinical trial that will study the activity of its proprietary monoclonal antibody BI-1206. (nordiclifescience.org)
  • March 11, 2021 -- Vir Biotechnology and GlaxoSmithKline (GSK) are moving ahead with regulatory submission of their COVID-19 monoclonal antibody (mAb), VIR-7831, after a data monitoring committee said that VIR-7831 worked so well in clinical trials that further study is not necessary to pursue an emergency use authorization (EUA) through the U.S. Food and Drug Administration (FDA). (scienceboard.net)
  • The recommendation was based on an interim analysis of data from a phase III clinical study of 583 patients enrolled in the COVID-19 Monoclonal antibody Efficacy Trial -- Intent to Care Early (COMET-ICE) trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 compared to placebo. (scienceboard.net)
  • The CTC.IOR supports and helps investigators in every phase: study planning, filing of the necessary documents for the presentation to the Ethical Committee, data monitoring, management and archiving of the documentation, publication of results. (ior.it)
  • comparisons) studied, a statement of trial is often cited as an experiment by the study hypothesis, definitions of the James Lind. (who.int)
  • HMS Salisbury, were divided into 6 study that prospectively assigns human data are considered complete), target groups. (who.int)
  • Physicians, surgeons, specialist nurses - any clinician seeking an accessible resource for designing and conducting cardiovascular trials and then translating their results into practice will appreciate this book's clear guidance and succinct and practical approach. (ellibs.com)
  • The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice. (nature.com)
  • Al-Razi's writings had a major influence conduct and administration of clinical enforced by one or more of the follow- on the development of medical practice trials. (who.int)
  • Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. (ellibs.com)
  • Dr. Teerlink completed a four-year term as a permanent member of the FDA Cardiovascular and Renal Drugs Advisory Committee, and frequently serves as an ad hoc member of multiple other FDA advisory committees and panels for medical devices, diagnostics, biologics, and drugs. (biospace.com)
  • He is a member of the joint FDA/Duke University Standardized Data Collection for Cardiovascular Clinical Trials Initiative to develop standardized definitions for cardiovascular endpoints. (biospace.com)
  • Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. (nih.gov)
  • This multicenter trial included esophageal cancer patients with clinical T4 disease and/or unresectable regional lymph node metastasis. (nih.gov)
  • Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. (nature.com)
  • The CTC.IOR was realized with the objective to favor the ( profit and non profit ) clinical experiments performed at the Institute, together with multicenter researches involving the Rizzoli Institute. (ior.it)
  • Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial Lancet Oncology 21 (10): 1317-1330,2020. (pennmedicine.org)
  • Phase III clinical trial of autologous CD34 + cell transplantation to accelerate fracture nonunion repair. (bvsalud.org)
  • We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. (springer.com)
  • The DMC reviewed data from GALACTIC-HF and recommended that this Phase 3 clinical trial of omecamtiv mecarbil continue without changes to its conduct. (amgen.com)
  • 1 The DMC considers all available evidence in its recommendations regarding trial conduct, and the stopping boundaries provide guidance to the DMC but are not binding rules. (amgen.com)
  • The FDA monitors trials and must give researchers permission to move from one phase to the next. (lbbc.org)
  • During phase III trials studying therapies for active treatment, researchers aren't allowed to give you no treatment, unless this is the standard of care for your disease. (lbbc.org)
  • The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests . (wikipedia.org)
  • To address the urgent medical need during the 2014 to 2016 outbreak, the clinical development of the 2-dose vaccine regimen comprising of Ad26.ZEBOV and MVA-BN-Filo was accelerated. (plos.org)
  • In two papers published Wednesday in the New England Journal of Medicine , Pfizer touted positive Phase III data for its respiratory syncytial virus (RSV) vaccine candidate, showing high levels of protection for older adults and infants. (biospace.com)
  • Given the high rate of occurrence of adverse effects that have been reported to date, as well as the potential for vaccine-driven disease enhancement, Th2-immunopathology, autoimmunity, and immune evasion, there is a need for a better understanding of the benefits and risks of mass vaccination, particularly in groups excluded from clinical trials. (researchgate.net)
  • Scandinavian Biopharma has been awarded a 10.6 million EUR grant from EDCTP in international competition for the planned Phase III clinical trial of the ETEC vaccine candidate ETVAX. (nordiclifescience.org)
  • Bivalent HPV vaccine - Update from the phase III vaccine efficacy trials. (cdc.gov)
  • And our final presenter is Lieutenant Stephen Perez, who is a clinical lead for the vaccine confidence team as part of CDC's COVID-19 response. (cdc.gov)
  • Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). (maps.org)
  • The results of the interim analysis of MAPS' pivotal first Phase 3 trial are the most powerful evidence yet that MDMA-assisted psychotherapy could help transform the lives of people suffering from PTSD. (maps.org)
  • FluoGuide has announced positive interim results from the phase IIa trial of its lead product FG001 in head & neck cancer. (nordiclifescience.org)
  • Is there an interim analysis planned for this trial? (who.int)
  • This product is conditionally approved based on the results of protective efficacy reported in interim analysis of the international Phase clinical trial. (who.int)
  • A second press release [2] has indicated stem cell source, resulting in widespread excitement that the program is planning to move forward very rapidly, with all of the patients being enrolled in the Correspondence to: Roger A. Barker, John van Geest Centre first quarter of 2016 and interim results being shared for Brain Repair, Department of Clinical Neurosciences, Univer- in October 2016. (lu.se)
  • Many randomized clinical trials are double-blind - no one involved with the trial knows what treatment is to be given to each trial participant. (wikipedia.org)
  • Cochrane groups have expanded , with the creation of specific methods groups that support reviews of individual participant data (IPD), screening and diagnostic tests, qualitative and implementation data, prognosis studies, non-randomised studies, and rapid reviews. (bmj.com)
  • A clinical trial participant receives an injection. (wikipedia.org)
  • Methods We conducted a retrospective chart review of a sample of patients with a clinical diagnosis of PD treated with DA in whom withdrawal or attempted withdrawal of DA was carried out because of adverse effects, or for any other reason. (bmj.com)
  • Arm Lead Investigators contribute to the CATALYST Trial by deputising some of the Chief Investigator's responsibilities for a specific arm of the trial. (birmingham.ac.uk)
  • The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative or existing treatments to compare to the new drug and what type(s) of patients might benefit. (wikipedia.org)
  • During the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment(s) and collect data on the subjects' health for a defined time period. (wikipedia.org)
  • It supports the clinical investigators with the aim of ensuring the progression of trials according to the protocols with particular reference to patient enrolment, informed consent, registration of results, appropriateness of setting, congruity of the information contained in the health documentation. (ior.it)
  • So we did have some data for Pfizer dose two, and we do have now data for Moderna dose two which is similar. (cdc.gov)
  • However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. (uea.ac.uk)
  • Reuters) - Merck & Co Inc said on Tuesday it will halt a late-stage trial of an Alzheimer's drug after it was determined that it had no chance of working, marking the latest in a long line of crushing disappointments in efforts to find an effective treatment for the disease. (scientificamerican.com)
  • Individuals living with dementia, caregivers and healthy volunteers without dementia are needed for Alzheimer's clinical trials. (alz.org)
  • This would allow the company sponsoring the trial to get regulatory approval earlier and to allow the superior treatment to get to the patient population earlier. (wikipedia.org)
  • It is extremely unlikely that the trial, should it continue to its normal end, would have the statistical evidence needed to convince a regulatory agency to approve the treatment. (wikipedia.org)
  • The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries. (jameslindlibrary.org)
  • Although the report of the streptomycin trial is rightly iconic, the attention it has attracted has led many historians to overlook earlier evidence relevant to the evolution of unbiased prospective allocation of patients to treatment comparison groups. (jameslindlibrary.org)
  • A randomised clinical trial, CopenHeart VR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. (biomedcentral.com)
  • Our group's preliminary data on DBT for adolescents with BP provide strong support for the feasibility and acceptability of the treatment model, and indicate DBT is associated with improvement in targeted treatment domains including suicidality, emotional dysregulation, and depression, and these improvements are greater among adolescents receiving DBT as compared with standard of care (SOC) psychotherapy delivered at our Child and Adolescent Bipolar Services (CABS) specialty clinic. (clinicaltrials.gov)
  • The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022. (maps.org)
  • Follow-up trials monitor people who have used a certain treatment or therapy over a long period to watch for changes in quality of life and side effects. (lbbc.org)
  • Some people believe that if they aren't given the trial treatment, they won't receive treatment at all. (lbbc.org)
  • If you aren't receiving the trial medicine, you'll get the same treatment you would have had outside of the trial. (lbbc.org)
  • The use of neoadjuvant systemic treatment in the clinical care of patients with breast cancer has increased dramatically over recent years. (nature.com)
  • The successful 1946 streptomycintrial is commonly regarded as a landmark in the development of clinical trial methodology, combining together for the first time the elements of randomization, meticulous recruitment and careful specification of treatments, including a control treatment. (statistics.com)
  • The clinical trial administrator, by contrast, is interested in testing the effect of a specific chemical compound or treatment protocol. (statistics.com)
  • Therefore, the result of a controlled clinical trial is the incremental improvement of the active component of the treatment over the placebo component. (statistics.com)
  • The webinar will feature a presentation by KOL John Teerlink, M.D., University of California-San Francisco, who will discuss the current treatment landscape and unmet medical need in treating patients with acute heart failure and the potential role for istaroxime, the company's product candidate, a first-in-class, dual action, agent in clinical development for the treatment of acute decompensated heart failure (ADHF). (biospace.com)
  • Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. (biospace.com)
  • A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination. (medscape.com)
  • Other clinical trials pertain to people with specific health conditions who are willing to try an experimental treatment. (wikipedia.org)
  • Toxicity was analysed in all patients who received trial treatment. (lu.se)
  • Nationally representative face-to-face household survey data from structured diagnostic interviews of the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III) (n = 36,309) were used to estimate percentages of respondents with 12-month DSM-5 mood, anxiety, and substance use disorders who received disorder-specific treatment during the 12 months before the interview. (psychiatrist.com)
  • clinical trial , formal testing of a specific treatment or other health-related intervention to determine its role in the standard care of individuals with a corresponding medical condition. (britannica.com)
  • 2This is the set of data generated by the subset of patients who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. (who.int)
  • Al-Razi's approach mum amount of information that must dures and to penalize those who do not to refining his treatment reflects a way be disclosed at registration for each trial comply. (who.int)
  • On May 2, 1997, ACHSP reviewed data on the role of STD detection and treatment in the prevention of HIV infection. (cdc.gov)
  • Prevention trials test methods of preventing cancer from forming or returning. (lbbc.org)
  • There is growing recognition that complex clinical and policy questions require more advanced evidence synthesis methods to answer them. (bmj.com)
  • The results strongly suggest that the FDA made the right decision in granting MAPS both (1) Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD, which accelerates the clinical trial process and acknowledges MDMA-assisted psychotherapy as a potentially significant advance over currently available treatments for PTSD, and (2) Expanded Access, which will allow some patients early access to MDMA-assisted psychotherapy for PTSD prior to approval. (maps.org)
  • 2020 . A real-time dashboard of clinical trials for COVID-19 . (ajtmh.org)
  • Deaths per million are evaluated using demographic data of the Belgian population (2020). (medrxiv.org)
  • The number of infections in Belgium is estimated by a stochastic compartmental model, which uses hospitalisation data, serial serological survey data, and COVID-19 mortality data (2020) for calibration. (medrxiv.org)
  • Results In Belgium, 9621 COVID-19 related deaths are reported between 9 March and 28 June 2020, which is close to the excess mortality estimated by weekly averages of historical mortality data (8985 deaths). (medrxiv.org)
  • Review data from the 2020 to 2021 U. (cdc.gov)
  • Phase II trials enroll up to a few hundred volunteers who have the condition the drug is designed to treat. (alz.org)
  • But an independent data monitoring committee determined that there was 'virtually no chance of finding a positive clinical effect' and recommended the trial be stopped for futility. (scientificamerican.com)
  • An independent data monitoring committee performed the radiographic assessments. (bvsalud.org)
  • This ensure the validity of the registration used by Abu Bakr Muhammad ibn Za- definition includes Phase I to Phase data. (who.int)
  • Separately, the companies also announced the publication of data in the preprint server, bioRxiv, demonstrating that VIR-7831 is effective against SARS-CoV-2 variants of concern, based on in vitro data from pseudotyped virus assays. (scienceboard.net)
  • cine ), which was translated into Latin in the 13th century and repeatedly printed "WHO regards trial registration as the Enforcement of registration of in Europe during the 15th and 16th publication of an internationally agreed clinical trials centuries under the title Liber continens . (who.int)
  • These data supported the approval by the European Union for prophylaxis against EBOV disease in adults and children ≥1 year of age. (plos.org)
  • Yet the number of adults who join cancer clinical trials is quite low. (lbbc.org)
  • Objective To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis. (bmj.com)
  • These data represent strong progress in the development of RSV vaccines. (biospace.com)
  • Both companies also won the backing of the FDA's Vaccines and Related Biological Products Advisory Committee in March. (biospace.com)
  • Our second presenter is Dr. Kathleen Dooling, who is a co-lead for the Advisory Committee for Immunization Practices COVID-19 Vaccines Workgroup as part of CDC's COVID-19 response. (cdc.gov)
  • Prevention and control of seasonal influenza and vaccines recommendations of advisory committee on immunization practices- United States 2021 to 2022 influenza season. (cdc.gov)
  • Sudden cardiac death secondary to cardiac arrhythmia is another concern, and continuous monitoring of heart rhythm is helpful in prompt diagnosis of dangerous arrhythmias. (medscape.com)
  • In May 1997, the Advisory Committee for HIV and STD Prevention (ACHSP) reviewed data on the relation between curable sexually transmitted diseases (STDs) and the risk for sexual transmission of human immunodeficiency virus (HIV). (cdc.gov)
  • The Advisory Committee for HIV and STD Prevention (ACHSP) provides oversight and guidance to CDC in the prevention of human immunodeficiency virus (HIV) -- the virus that causes acquired immunodeficiency syndrome (AIDS) -- and other sexually transmitted diseases (STDs). (cdc.gov)
  • Recommendations for prevention and control of influenza in children 2021 to 2022 and in the CDC advisory committee practices document. (cdc.gov)
  • therefore, use diagnostic immunohistochemistry testing in conjunction with morphologic and clinical findings. (medscape.com)
  • Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. (who.int)
  • The FDA and other regulators can establish a set of principles and rules governing clinical trials and drug development, but they cannot place staff in all the pharmaceutical labs and medical clinics to observe procedures and enforce rules. (statistics.com)
  • He also currently serves on the Acute Heart Failure Committee of the European Society of Cardiology Heart Failure Association and has served on the National Committee on Heart Failure and Transplantation of the American Heart Association. (biospace.com)
  • Based on discussions held by a global collaborative initiative on translation of stem cell therapy in Parkinson's disease, we have identified a set of key questions that we believe should be addressed ahead of every clinical stem cell-based transplantation trial in this disorder. (lu.se)
  • citation needed] As an example, suppose a trial is one-half completed, but the experimental arm and the control arm have nearly identical results. (wikipedia.org)
  • However, it is questionable whether the results from these trials are transferable to a heart valve surgery population. (biomedcentral.com)
  • Herein, we present the results of a phase III clinical trial conducted to confirm the results of the previous phase studies using a larger cohort of patients . (bvsalud.org)
  • And these results are consistent with what was observed in the clinical trials and are essentially expected. (cdc.gov)
  • Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics, commented, "These encouraging data support the clinical advancement of SYN-004 and build on the growing data that underscore its therapeutic potential. (therivabio.com)
  • The data will also be used to support a biologics license application (BLA) submission to the FDA. (scienceboard.net)
  • Click to search our clinical trials glossary. (lupustrials.org)
  • Click here to search lupus trials by where you live and the type of lupus you have. (lupustrials.org)
  • Use this tool to search all lupus trials and create a personalized list of studies by the type of lupus you have and where you live. (lupustrials.org)
  • The CTC.IOR was formally constituted at the beginning of 2018, as a simple structure embedded in the Scientific Direction , and functions as an interface with the Healthcare Direction, the Clinical Departments and the Operative Units. (ior.it)
  • Participation in trials is how we ensure that high quality care. (lbbc.org)
  • 3] The National Cancer Institute (NCI) recommends that high-risk women seek advice from their physicians and consider having annual ultrasonographic examinations and annual CA125 testing, as well as consider oophorectomy or participation in a clinical trial. (medscape.com)
  • Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required. (nih.gov)
  • With this background information as a foundation, we then discuss each of the key questions in relation to the upcoming therapeutic trial and critically assess if the time is ripe for clinical translation of parthenogenetic stem cell technology in Parkinson's disease. (lu.se)
  • Instead, if a clinical suggestion of ovarian cancer is present, the patient should undergo laparoscopic evaluation or laparotomy, based on the presentation, for diagnosis and staging. (medscape.com)
  • The most common adverse reactions observed in multiple Phase â…¢ clinical studies on lorcaserin were headache, dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycemia, headache, back pain, cough and fatigue in patients with diabetes. (eisai.com)
  • At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies. (merck.com)
  • Whilst we don't know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer. (medscape.com)
  • Merck last month announced it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. (medscape.com)
  • Windtree's management team will also discuss the clinical development program for istaroxime, which has been studied in two Phase 2 clinical trials to date. (biospace.com)
  • Dr. Teerlink is an active member of the Heart Failure Society of America, serving on many committees including the Membership, Scientific Program, Corporate Affairs, Development, Lifetime Achievement Award and Guideline Committees, and currently serves as Secretary and on the Board of Directors and the Executive Council. (biospace.com)
  • In pulmonary care, Windtree has focused on developing AEROSURF®, a drug-device combination, to deliver its synthetic KL4 surfactant non-invasively to premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee's HK. (biospace.com)
  • We will now prepare the next steps for development of FG001 over the coming months, considering data from all three indications - lung, head & neck and aggressive brain cancers - and potential partner interest," says Albrechtsen. (nordiclifescience.org)
  • [1] [2] They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. (wikipedia.org)