Clinical Trials as Topic: 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.Clinical Trials, Phase III as Topic: 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.Clinical Trials, Phase II as Topic: 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.Treatment Outcome: 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.Clinical Trials, Phase I as Topic: 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.Research Design: 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.Controlled Clinical Trials as Topic: 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.Double-Blind Method: 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.Randomized Controlled Trials as Topic: 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.Patient Selection: 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.Multicenter Studies as Topic: 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.Time Factors: Elements of limited time intervals, contributing to particular results or situations.Clinical Trials, Phase IV as Topic: 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.Placebos: 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.Clinical Trials Data Monitoring Committees: 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.Neoplasms: 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.Clinical Protocols: Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.Prospective Studies: 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.Evidence-Based Medicine: 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)Follow-Up Studies: 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.Single-Blind Method: A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Antineoplastic Agents: Substances that inhibit or prevent the proliferation of NEOPLASMS.Early Termination of Clinical Trials: Earlier than planned termination of clinical trials.Congresses as Topic: Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.United StatesDrug Therapy, Combination: Therapy with two or more separate preparations given for a combined effect.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Sample Size: 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)Pilot Projects: 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.Quality of Life: 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.Review Literature as Topic: Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.Guidelines as Topic: 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.Research Subjects: Persons who are enrolled in research studies or who are otherwise the subjects of research.Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Questionnaires: 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.Outcome Assessment (Health Care): 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).Meta-Analysis as Topic: 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.Patient Education as Topic: The teaching or training of patients concerning their own health needs.Cost-Benefit Analysis: 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.Abstracting and Indexing as Topic: Activities performed to identify concepts and aspects of published information and research reports.Severity of Illness Index: Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.Practice Guidelines as Topic: 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.Combined Modality Therapy: 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.Antineoplastic Combined Chemotherapy Protocols: 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.Endpoint Determination: 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.Risk Factors: 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.Dose-Response Relationship, Drug: The relationship between the dose of an administered drug and the response of the organism to the drug.Informed Consent: 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.Textbooks as Topic: Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Survival Analysis: 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.Reproducibility of Results: 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.Research Support as Topic: Financial support of research activities.Risk Assessment: 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)Patient Compliance: Voluntary cooperation of the patient in following a prescribed regimen.Medical Oncology: A subspecialty of internal medicine concerned with the study of neoplasms.Breast Neoplasms: Tumors or cancer of the human BREAST.Drugs, Investigational: 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.Placebo Effect: 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.Patient Participation: Patient involvement in the decision-making process in matters pertaining to health.Recurrence: The return of a sign, symptom, or disease after a remission.Data Interpretation, Statistical: Application of statistical procedures to analyze specific observed or assumed facts from a particular study.Prognosis: 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.Terminology as Topic: The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.Feasibility Studies: Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.Dietary Supplements: 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.Disease Progression: 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.Publishing: "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.Pain Measurement: 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.Drug Industry: 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.Benchmarking: Method of measuring performance against established standards of best practice.Interviews as Topic: Conversations with an individual or individuals held in order to obtain information about their background and other personal biographical data, their attitudes and opinions, etc. It includes school admission or job interviews.Survival Rate: 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.Disease-Free Survival: Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.United States Food and Drug Administration: 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.Drug Evaluation: 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.Drug Approval: 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.Stroke: 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)Cross-Over Studies: 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)HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).Exercise Therapy: 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.Random Allocation: 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.Patient Satisfaction: 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.Therapeutic Human Experimentation: Human experimentation that is intended to benefit the subjects on whom it is performed.Intention to Treat Analysis: Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.Internet: 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.Cognitive Therapy: 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.Biological Markers: 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.Antibodies, Monoclonal: Antibodies produced by a single clone of cells.Drug Combinations: Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.Infusions, Intravenous: 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.National Institutes of Health (U.S.): 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.Lung Neoplasms: Tumors or cancer of the LUNG.Phytotherapy: Use of plants or herbs to treat diseases or to alleviate pain.Bias (Epidemiology): 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.Retrospective Studies: 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.Patient Dropouts: Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.Programmed Instruction as Topic: Instruction in which learners progress at their own rate using workbooks, textbooks, or electromechanical devices that provide information in discrete steps, test learning at each step, and provide immediate feedback about achievement. (ERIC, Thesaurus of ERIC Descriptors, 1996).Data Collection: 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.Analysis of Variance: A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.Chronic Disease: 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)National Cancer Institute (U.S.): 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.Pain: An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.Research: 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)Antibodies, Monoclonal, Humanized: 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.Research Personnel: Those individuals engaged in research.Drug-Related Side Effects and Adverse Reactions: 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.Acute Disease: Disease having a short and relatively severe course.Chemotherapy, Adjuvant: 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.Societies, Medical: Societies whose membership is limited to physicians.Drug Evaluation, Preclinical: Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.Statistics as Topic: The science and art of collecting, summarizing, and analyzing data that are subject to random variation. The term is also applied to the data themselves and to the summarization of the data.Predictive Value of Tests: 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.Treatment Failure: 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.Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.Great BritainHealth Knowledge, Attitudes, Practice: Knowledge, attitudes, and associated behaviors which pertain to health-related topics such as PATHOLOGIC PROCESSES or diseases, their prevention, and treatment. This term refers to non-health workers and health workers (HEALTH PERSONNEL).Kaplan-Meier Estimate: 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)Age Factors: 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.Immunotherapy: 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.Safety: 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.Translational Medical Research: 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.EuropeDecision Making: 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.Infant, Newborn: An infant during the first month after birth.Counseling: The giving of advice and assistance to individuals with educational or personal problems.Pragmatic Clinical Trials as Topic: Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.Cohort Studies: 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.Program Evaluation: 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.Statistics, Nonparametric: 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)Molecular Targeted Therapy: Treatments with drugs which interact with or block synthesis of specific cellular components characteristic of the individual's disease in order to stop or interrupt the specific biochemical dysfunction involved in progression of the disease.Neoplasm Staging: Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.Herbals as Topic: Works about books, articles or other publications on herbs or plants describing their medicinal value.Canada: The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.Cardiovascular Diseases: Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.Publication Bias: The influence of study results on the chances of publication and the tendency of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Publication bias has an impact on the interpretation of clinical trials and meta-analyses. Bias can be minimized by insistence by editors on high-quality research, thorough literature reviews, acknowledgement of conflicts of interest, modification of peer review practices, etc.Communication: The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.Anti-Bacterial Agents: Substances that reduce the growth or reproduction of BACTERIA.Motivation: Those factors which cause an organism to behave or act in either a goal-seeking or satisfying manner. They may be influenced by physiological drives or by external stimuli.Sensitivity and Specificity: 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)Ethics Committees, Research: 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.Models, Statistical: 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.Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Incidence: 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.Genetic Therapy: Techniques and strategies which include the use of coding sequences and other conventional or radical means to transform or modify cells for the purpose of treating or reversing disease conditions.Recovery of Function: A partial or complete return to the normal or proper physiologic activity of an organ or part following disease or trauma.Anti-HIV Agents: Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS.Databases as Topic: Organized collections of computer records, standardized in format and content, that are stored in any of a variety of computer-readable modes. They are the basic sets of data from which computer-readable files are created. (from ALA Glossary of Library and Information Science, 1983)Ethics, Medical: 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.Human Experimentation: The use of humans as investigational subjects.Evaluation Studies as Topic: 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.Conflict of Interest: 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.Cancer Vaccines: Vaccines or candidate vaccines designed to prevent or treat cancer. Vaccines are produced using the patient's own whole tumor cells as the source of antigens, or using tumor-specific antigens, often recombinantly produced.National Institute on Drug Abuse (U.S.): Component of the NATIONAL INSTITUTES OF HEALTH. It supports a comprehensive research portfolio that focuses on the biological, social, behavioral and neuroscientific bases of drug abuse on the body and brain as well as its causes, prevention, and treatment. NIDA, NIAAA, and NIMH were created as coequal institutes within the Alcohol, Drug Abuse and Mental Health Administration in 1974. It was established within the NATIONAL INSTITUTES OF HEALTH in 1992.Anticoagulants: Agents that prevent clotting.Myocardial Infarction: NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).Behavior Therapy: The application of modern theories of learning and conditioning in the treatment of behavior disorders.Ethics, Research: The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.International Cooperation: The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.Chi-Square Distribution: A distribution in which a variable is distributed like the sum of the squares of any given independent random variable, each of which has a normal distribution with mean of zero and variance of one. The chi-square test is a statistical test based on comparison of a test statistic to a chi-square distribution. The oldest of these tests are used to detect whether two or more population distributions differ from one another.Multivariate Analysis: 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.Proportional Hazards Models: 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.Administration, Topical: The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example.Quality Control: 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)Internationality: The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)Drug Therapy: The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER.Paclitaxel: A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.Comparative Effectiveness Research: Conduct and synthesis of systematic research comparing interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. (hhs.gov/recovery/programs/cer/draftdefinition.html accessed 6/12/2009)Postoperative Complications: Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.Health Education: Education that increases the awareness and favorably influences the attitudes and knowledge relating to the improvement of health on a personal or community basis.Curriculum: A course of study offered by an educational institution.Pain Management: A form of therapy that employs a coordinated and interdisciplinary approach for easing the suffering and improving the quality of life of those experiencing pain.Bookplates as Topic: Labels pasted in books to mark their ownership and sometimes to indicate their location in a library. Private bookplates are often ornate or artistic: simpler and smaller ones bearing merely the owner's name are called "book labels." They are usually pasted on the front endpaper of books. (From Harrod, The Librarians' Glossary and Reference Book, 4th rev ed & Random House Unabridged Dictionary, 2d ed)Broadsides as Topic: Published pieces of paper or other material, usually printed on one side and intended to be read unfolded and usually intended to be posted, publicly distributed, or sold. (From Genre Terms: A Thesaurus for Use in Rare Book and Special Collections Cataloguing, 2d ed)Exercise: Physical activity which is usually regular and done with the intention of improving or maintaining PHYSICAL FITNESS or HEALTH. Contrast with PHYSICAL EXERTION which is concerned largely with the physiologic and metabolic response to energy expenditure.Risk Reduction Behavior: Reduction of high-risk choices and adoption of low-risk quantity and frequency alternatives.Smoking Cessation: Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.Control Groups: Groups that serve as a standard for comparison in experimental studies. They are similar in relevant characteristics to the experimental group but do not receive the experimental intervention.Health Promotion: Encouraging consumer behaviors most likely to optimize health potentials (physical and psychosocial) through health information, preventive programs, and access to medical care.Databases, Factual: 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.Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.Diabetes Mellitus, Type 2: A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.Magnetic Resonance Imaging: Non-invasive method of demonstrating internal anatomy based on the principle that atomic nuclei in a strong magnetic field absorb pulses of radiofrequency energy and emit them as radiowaves which can be reconstructed into computerized images. The concept includes proton spin tomographic techniques.MEDLINE: The premier bibliographic database of the NATIONAL LIBRARY OF MEDICINE. MEDLINE® (MEDLARS Online) is the primary subset of PUBMED and can be searched on NLM's Web site in PubMed or the NLM Gateway. MEDLINE references are indexed with MEDICAL SUBJECT HEADINGS (MeSH).Neoplasm Recurrence, Local: 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.Anti-Inflammatory Agents: Substances that reduce or suppress INFLAMMATION.Disease Models, Animal: Naturally occurring or experimentally induced animal diseases with pathological processes sufficiently similar to those of human diseases. They are used as study models for human diseases.Prostatic Neoplasms: Tumors or cancer of the PROSTATE.Regression Analysis: Procedures for finding the mathematical function which best describes the relationship between a dependent variable and one or more independent variables. In linear regression (see LINEAR MODELS) the relationship is constrained to be a straight line and LEAST-SQUARES ANALYSIS is used to determine the best fit. In logistic regression (see LOGISTIC MODELS) the dependent variable is qualitative rather than continuously variable and LIKELIHOOD FUNCTIONS are used to find the best relationship. In multiple regression, the dependent variable is considered to depend on more than a single independent variable.Australia: The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra.Health Care Costs: 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.Therapeutic Equipoise: Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.Physical Therapy Modalities: Therapeutic modalities frequently used in PHYSICAL THERAPY SPECIALTY by PHYSICAL THERAPISTS or physiotherapists to promote, maintain, or restore the physical and physiological well-being of an individual.Bibliometrics: The use of statistical methods in the analysis of a body of literature to reveal the historical development of subject fields and patterns of authorship, publication, and use. Formerly called statistical bibliography. (from The ALA Glossary of Library and Information Science, 1983)Individualized Medicine: Therapeutic approach tailoring therapy for genetically defined subgroups of patients.Drug Delivery Systems: Systems for the delivery of drugs to target sites of pharmacological actions. Technologies employed include those concerning drug preparation, route of administration, site targeting, metabolism, and toxicity.Drug Discovery: The process of finding chemicals for potential therapeutic use.Netherlands: Country located in EUROPE. It is bordered by the NORTH SEA, BELGIUM, and GERMANY. Constituent areas are Aruba, Curacao, Sint Maarten, formerly included in the NETHERLANDS ANTILLES.Attitude of Health Personnel: Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.Germany
Pragmatic Approaches (CIOMS V); Management of Safety Information from Clinical Trials (CIOMS VI); the Development Safety Update ... The CIOMS, a part of the WHO, is a globally oriented think tank that provides guidance on drug safety related topics through ... whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license ... The variables in a clinical trial are specified and controlled, but a clinical trial can never tell you the whole story of the ...
... modeling approaches, as well as clinical trials. The Journal of Biological Rhythms covers topics in chronobiology, namely ... Early research topics included "splitting," circannual rhythmicity, photoperiodic time measurement, and circadian pacemaker ... The journal also publishes special publication collections consisting of selected articles on a chosen topic. These collections ...
A variety of approaches are explored by the journal including: genetic, behavioral, modeling, and clinical trials. In 2015 SAGE ... The JBR publishes scholarly articles, original research, and reviews on a variety of topics all centering around periodicity in ...
"Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial". Nature Medicine ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... Clinical trials using LY-2140023 have investigated its use as a therapy when administered alone and as an adjuvant therapy used ... Results of the clinical trial indicated that neither LY-2140023 nor olanzapine were significantly more efficacious than the ...
The trial was published in JAMA in early 2006. Ongoing work starting in the 1990s may lead to human clinical trials-probably by ... www.nhlbi.nih.gov/health/health-topics/topics/atherosclerosis/atrisk Enas EA, Kuruvila A, Khanna P, Pitchumoni CS, Mohan V ( ... The immunomodulation approaches mentioned above, because they deal with innate responses of the host to promote atherosclerosis ... Most severe clinical events do not occur at plaques that produce high-grade stenosis. From clinical trials, only 14% of heart ...
From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to ... Quality Systems Approach to Pharmaceutical CGMP Regulations" (PDF). U.S. Food and Drug Administration. September 2006. ... "Guidance for Industry: Computerized Systems Used in Clinical Trials" (PDF). U.S. Food and Drug Administration. April 1999. ...
Pritchard's clinical trials have yielded findings that have transformed breast cancer treatment approaches worldwide. Pritchard ... Pritchard is an oncologist and researcher with involvement in numerous clinical studies. Her research spans a range of topics, ... with Henri Rochefort) "Clinical cooperative trials of the national cancer institute of Canada clinical trials group breast ... One of Pritchard's self-proclaimed "eureka" moments was in a clinical trial concerning the use of the drug Letrozole as an ...
Randomized clinical trials were reported in the journal for the first time. From 1998-2003, the editorship passed to Carol ... During Imber-Black's editorship, the journal published both clinical and research issues on such topics as divorce, Latino ... These different paradigms, belief systems, sets of assumptions, and approaches to knowledge inhabited the journal side by side ... Contents and topics of articles include LGBTQ families in therapy, couple therapy and narrative therapy in the 21st century. ...
... are currently three classes of therapies that have been utilized in both animal models of disease and in human clinical trials ... Neuroimmunology is also an important topic to consider during the design of neural implants. Neural implants are being used to ... The final therapy includes using RNA-based approaches to enhance stability, specificity, and efficacy, especially in diseases ... These three classes include DNA methylation inhibitors, HDAC inhibitors, and RNA-based approaches. DNA methylation inhibitors ...
"Statistical analysis of clinical trials", Clinical Trials. Issues and Approaches, Marcel Dekker, pp. 155-189 Meier, Paul (1984 ... "Current research in statistical methodology for clinical trials", Biometrics -- Proceedings of Current Topics in Biostatistics ... "Stratification in the design of a clinical trial", Controlled Clinical Trials, 1 (4): 355-361, doi:10.1016/0197-2456(81)90040-4 ... "Jerome Cornfield and the methodology of clinical trials", Controlled Clinical Trials, 1 (4): 339-345, doi:10.1016/0197-2456(81) ...
The potent Hsp90 inhibitor 17-AAG was in clinical trials for the treatment of several types of cancer, but for various reasons ... Didelot C, Lanneau D, Brunet M, Joly AL, De Thonel A, Chiosis G, Garrido C (2007). "Anti-cancer therapeutic approaches based on ... Solit DB, Rosen N (2006). "Hsp90: a novel target for cancer therapy". Current Topics in Medicinal Chemistry. 6 (11): 1205-14. ... HSPgp96 also shows promise as an anticancer treatment and is currently in clinical trials against non-small cell lung cancer. ...
Whereas randomized clinical trials usually only inspect one variable or very few variables, rarely reflecting the full picture ... Unique therapeutic approaches. A positional or quantitative variation of the anatomical structures. A case report is generally ... Most case reports are on one of six topics: An unexpected association between diseases or symptoms. An unexpected event in the ... Yitschaky O, Yitschaky M, Zadik Y (May 2011). "Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth ...
To demonstrate the clinical relevance of the suggested approach, each section begins with a practical clinical scenario. The ... Applying Clinical Trial Results; A. How to Use an Article Measuring the Effect of an Intervention on Surrogate End Points. JAMA ... The guides originally consisted of 25 topics, covered in a series of 32 articles published in the Journal of the American ... Applying Clinical Trial Results; B. Guidelines for Determining Whether a Drug Is Exerting (More Than) a Class Effect. JAMA, 282 ...
... is a clinical approach to those experiencing symptoms of psychosis for the first time. It forms ... the TIPS early detection randomised control trial in Norway; and the Danish OPUS trial. In 2001, the United Kingdom Department ... where thoughts unrelated to a common topic appear uncontrollably; referential ideation that is immediately corrected; and other ... Multidisciplinary clinical teams providing an intensive case management approach for the first three to five years. The ...
Currently, there is no effective HIV vaccine but many research projects managing clinical trials seek to create one. There is ... Current approaches are focussing on recombinant protein and attenuated whole organism vaccines. Various vaccines have reached ... It is a primary goal of artificial intelligence research and an important topic for science fiction writers and futurists. ... Potential candidates for antibodies and early stage results from clinical trials have been announced. Malaria vaccines are an ...
Lasagna's work led to the improvement of controlled clinical trials to test drug effectiveness, and improved the regulation of ... Throughout Lasagna's distinguished career he wrote and lectured extensively on a variety of topics. He was well known for his ... In 1964, Lasagna wrote a modernized version of the Hippocratic Oath, which emphasized a holistic and compassionate approach to ... His guidance resulted in, among other things, the requirement for controlled clinical trials as necessary for proving drug ...
He is known for often taking darkly comic approaches to serious or offbeat topics. His New Yorker article, Guinea Pigging, ... "The Deadly Corruption of Clinical Trials" Mother Jones, September/October 2010. Susan Perry. "U of M suspends enrollment in ... psychiatric drug trials after in the wake of scathing report on Markingson case" MinnPost, March 20, 2015. Carl Elliott's ...
Kowey said the book's main weakness was a lack of focus on clinical issues - both in topics covered and author selection. He ... examines drugs in clinical trial at the time of publication. The chemical structure of existing drugs is not covered. Overall, ... In a review for Circulation, Kowey called the book "an admirable attempt" to develop a more targeted approach to arrhythmia ... noted that bringing drugs to the marketplace is expensive and proof of concept clinical trials are necessary to justify the ...
... towards a collaborative open database of all available information on all clinical trials". Trials. 17: 164. doi:10.1186/s13063 ... Approaches[edit]. In 2017, a book was published on patient involvement in HTA (Eds Facey KM, Hansen HP, Single ANV) bringing ... In 2011 a seminal[peacock term] paper on the topic came out written by Hood and Friend.[48] ... such as the experimental derived from clinical trials, evidential, derived from existing clinical practice, and experiential, ...
Safer and more effective clinical trials. Evolution[edit]. This section may stray from the topic of the article. Please help ... Inherent in the concept of connected health is flexibility in terms of technological approaches to care delivery and specific ... "Journal of Evaluation in Clinical Practice. 18 (1): 56-62. doi:10.1111/j.1365-2753.2010.01522.x. ISSN 1365-2753. PMID 20698917. ...
Senate and Department of Justice started investigations of Medtronic over the omissions of safety problems from clinical trials ... "guerrilla science approach", writing more than 35 letters to medical journals. Smoljanović's complaints finally caught the ... but both the letters and Smoljanović's review article on the topic were rejected for publication. Nevertheless, he remained ...
... consent Data Monitoring Committees Office for human research protections Ethical problems using children in clinical trials ... While little is known about the range and distribution of topics put forth for REC, such services may be particularly important ... or to pursue a different approach. Institutional Review Board Ethics Committee (European Union) Human experimentation in the ... Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit ...
Medicine portal Diet and cancer Clinical trial Placebo effect Pseudoscience List of topics characterized as pseudoscience " ... Treatments following this approach are usually aimed at detoxification or body cleansing, such as enemas. Low activity by the ... a systematic review of clinical trials". Journal of Clinical Oncology. 24 (1): 136-40. doi:10.1200/JCO.2005.03.8406. PMC ... Some treatments that have been proposed in the past have been found in clinical trials to be useless or unsafe. Some of these ...
... the EXCITE randomized clinical trial". JAMA: The Journal of the American Medical Association. 296 (17): 2095-104. doi:10.1001/ ... Topics in Stroke Rehabilitation. 20 (3): 197-209. doi:10.1310/tsr2003-197. hdl:10044/1/32069. PMID 23841967.. ... "An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping". Journal of the Experimental Analysis of ... systematic review and meta-analysis of randomised controlled trials". BMJ (Clinical Research Ed.). 347 (20): f6234. doi:10.1136 ...
The U.S. National Institutes of Health states that "Most clinical trials of Ayurvedic approaches have been small, had problems ... The topic of this article may not meet Wikipedia's general notability guideline. Please help to establish notability by citing ... Clinical trials on Ayurvedic drugs are clinical trials carried out on Ayurvedic medicine. ... "Clinical trials on Ayurvedic drugs" - news · newspapers · books · scholar · JSTOR (April 2015) (Learn how and when to remove ...
... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... Mayo Clinic (2007). Mayo Clinic Book of Alternative Medicine: The New Approach to Using the Best of Natural Therapies and ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ... Gorski, DH; Novella, SP (September 2014). "Clinical trials of integrative medicine: testing whether magic works?". Trends in ...
We searched the trials registry ClinicalTrials.gov on 6 October 2016 to identify all phase III/IV drug clinical trials of ... What is already known on this topic. *. Core outcome sets can enhance the relevance of research by ensuring that a standardised ... Publications that included the clinical trial registry number of a trial but did not report on the trial findings were excluded ... Assessment of trial reports. We searched for trial publications for all eligible trials that had been identified on the trial ...
This was to ensure that the trial would be considered by advocates of each approach to have been a credible and fair test of ... What is already known on this topic. *. Postnatal depression is a global problem that can persist beyond the first postnatal ... Clinical effectiveness.... *Clinical effectiveness of health visitor training in psychologically informed approaches for ... This large trial of treatment for postpartum depression is unique in the comparison of the cognitive behavioural approach and ...
Topics. *Fair tests of treatments*The need to address treatment uncertainties. *Treatment comparisons are essential*Placebo ... with clinical trials of secondary importance. He thought the Committee members conceptualised the clinical trial primarily as a ... During its existence [the Therapeutic Trials Committee] did not organise one rigorous comparative clinical trial, despite prima ... The Therapeutic Trials Committee and the trial of serum treatment of pneumonia. The Therapeutic Trials Committee inherited from ...
Mayo Clinic Clinical Trials Publications: Afessa B, Hubmayr RD, Vetter EA, Keegan MT, Swanson KL, Baddour LM, Cockerill FR 3rd ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP). The safety and ... Completion of this trial will help us identify the best approach to avoid unnecessary antibiotic utilization and minimize the ...
... crossover trial in HIV-infected patients with HAART-induced dyslipidemia. ... Therapeutic Approaches to HAART-Induced Lipodystrophy. Resource links provided by NLM:. MedlinePlus related topics: HIV/AIDS ... Results from these studies may help in designing therapeutic approaches to HAART-induced lipodystrophy and its metabolic ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461552 ...
Interventional (Clinical Trial) Estimated Enrollment :. 2000 participants. Allocation:. Randomized. Intervention Model:. ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers (TEAM). The safety and scientific ... Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Yap TL, Kennerly SM, Simmons MR ...
Eligible randomized clinical trials evaluated lifestyle modification (LSM) and medication interventions (>6 months) for ...
Clinical Trials as Topic * Drug Design * Drug Evaluation, Preclinical * Humans * Imidazoles / chemistry ... have progressed to advanced preclinical development or early phase clinical trials. ... Small-molecule inhibitors of the MDM2-p53 protein-protein interaction to reactivate p53 function: a novel approach for cancer ...
Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182. NCCIH ... The goal of this FOA is to provide support to investigators for such early phase clinical trials on mind and body approaches ... The goal of this funding opportunity is to support early phase clinical trials of mind and body approaches for conditions that ... Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) ...
Research on Current Topics in Alzheimers Disease and Its Related Dementias (R01 Clinical Trial Optional) PAR-18-596. NIA ... approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ...
Genetics Home Reference related topics: Multiple sclerosis MedlinePlus related topics: Memory Multiple Sclerosis ... Interventional (Clinical Trial) Estimated Enrollment :. 120 participants. Allocation:. Randomized. Intervention Model:. ... Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS (STEM). The safety and scientific ... Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our ...
Explore this Health Topic to learn more about genetic therapies, our role in research and clinical trials to improve health, ... in NHLBI Clinical Trials will discuss our open and enrolling clinical studies that are investigating genetic approaches for ... Participate in NHLBI Clinical Trials will discuss our open and enrolling clinical studies that are investigating genetic ... Participate in NHLBI Clinical Trials will discuss our open and enrolling clinical studies that are investigating genetic ...
Clinical Trials as Topic * Cluster Analysis * Colonic Neoplasms / drug therapy * Colonic Neoplasms / mortality ... Cox regression analysis of multivariate failure time data: the marginal approach Stat Med. 1994 Nov 15;13(21):2233-47. doi: ... This approach formulates the marginal distributions of multivariate failure times with the familiar Cox proportional hazards ... Detailed illustrations with data from four clinical or epidemiologic studies are provided. ...
Emerging Treatment Approaches. *The Role of Clinical Trials. *How Research Contributes to Treatment Choices ... Browse by Topic. Please select. Adherence. Adolescents and Young Adults. Advanced Cancer. Advocacy. Affordable Care Act. ... Attending Physician, Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, Professor of Clinical ... Host Disease (GVHD) Post Allogeneic Stem Cell or Bone Marrow Transplantation: New Treatment Approaches ...
... choosing a successful treatment from several possible drugs remains a trial-and-error process in current clinical practice. By ... In this approach, high dimensional dynamic programs are solved approximately as large-scale linear programs to tackle the curse ... In this talk, we will focus on two important topics in modern data analysis: (1) K-means clustering and (2) low-rank ... A major challenge of the approach therefore lies in efficient solution of the ALPs. In this talk, I report some recent ...
A modern approach to normal theory for general linear models including models with random effects and "messy" data. Topics ... design of clinical trials; data monitoring and interim analysis. Prerequisite: STAT 450 or permission of the instructor. ... The theory and application of statistical approaches for the analysis of spatial and time dependent data. Topics will include: ... Principles, methods and applications of basic statistical approaches in biomedical studies are presented. Topics include ...
Whereas using several trials overcomes some of the limitations of a single-trial framework (Prentice, 1989, Statistics in ... Clinical Trials as Topic / statistics & numerical data*. Endpoint Determination / statistics & numerical data*. Humans. ... 20191605 - A confirmatory seamless phase ii/iii clinical trial design incorporating short-term end.... 24925875 - A multi- ... 3060315 - Statistical properties of randomization in clinical trials.. 16374365 - Preclinical models of shock and sepsis: what ...
C.04.e. Clinical trials for movement disorders other than Parkinsons. *C.05. Tauopathies, Tau-dementias, and Prion diseases. C ... C.09.d. Stroke recovery - Pharmacological approaches to therapy. C.09.e. Stroke recovery - Non-pharmacological approaches to ... C.02.v. Therapeutic strategies - Clinical trials. C.02.w. Proteinopathy and pathology other than Abeta/tau. C.02.x. Other ... C.02.g. Clinical and pre-clinical imaging studies in Alzheimers disease. C.02.h. APP and metabolites - Function and processing ...
... conducts scientific conferences on biomedical and life science topics in relaxing environments that catalyze information ... A Different Approach to Early Clinical Trials. John C.R. Randle, Vertex Pharmaceuticals Incorporated, USA ICE Inhibitors for ... Clinical Trial Design for Antidepressants: A Pharmacogenomics Approach. Colin Garner, , UK Human Phase 0 (Microdosing): Big ... Clinical Trials Design. Session Sponsored by Vertex Pharmaceuticals Incorporated. Meeting has ended...abstracts no longer ...
Growing adoption of robotic surgery and precision medicine, growing number of clinical trials and others are other drivers of ... Key Topics:. *Bolster project portfolio organization through a holistic approach. *Optimize ROI through a strategic approach to ... GAIN a practical working knowledge of clinical trial process for pharmaceutical products ... Clinical Trials, Cybersecurity, Drug Discovery. March 15th, 2018 Market Research Future Releases ...
... will be assessed in a clinical study to be overseen by Bayer ... Compugen said the FDA has lifted the clinical hold on PVRIG- ... and was also shown to have additive antitumor effects in combination with other cancer therapy approaches in those models, ... Topics *. AllBioprocessingCancerDrug DiscoveryOMICsTranslational MedicineGenome Editing. Drug Discovery ... Compugen today said clinical trials will be launched for a pair of its cancer immunotherapy candidates targeting advanced solid ...
NIH Study Supports Use of Short-Term HIV Treatment Interruption in Clinical Trials. January 12, 2018 70 views ... Dengue Takes Low and Slow Approach to Replication. January 12, 2018 33 views ...
Topics covered will include clinical pharmacology, candidate selection, contraindications, and results from trials. ... PsychedeLiAs program takes a harm reduction approach with these objectives:. * We aim to provide accurate information about ... Both MDMA and psilocybin are being studied as experimental therapies in combination with psychotherapy approaches. Additionally ... Benjamin Malcolm teaches psychopharmacology, practices as a clinical psychiatric specialist, and performs research on ...
Statistics as Topic * Bayesian analysis: A practical approach to interpret clinical trials and create clinical practice ... We evaluated MDR-TB treatment outcomes from a clinical cohort with task-sharing between a clinical nurse practitioner (CNP) and ... we avoid a common pitfall in traditional meta-analysis and create a network of randomized clinical trials to compare outcomes ... to show how Bayesian analysis takes evidence from randomized clinical trials to update what is already known about specific ...
NIH Study Supports Use of Short-Term HIV Treatment Interruption in Clinical Trials. January 12, 2018 70 views ... Dengue Takes Low and Slow Approach to Replication. January 12, 2018 33 views ...
  • Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. (bmj.com)
  • The selection of appropriate outcomes is crucial to the design of randomised trials. (bmj.com)
  • If the findings of a trial are to influence healthcare, the outcomes that are measured and reported need to be relevant to patients, healthcare professionals, and others making decisions about healthcare provision. (bmj.com)
  • A core outcome set has previously been defined as an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare. (bmj.com)
  • 2 The adoption of a core outcome set can reduce heterogeneity in reported outcomes between trials and reduce the risk of outcome reporting bias, since trial reports would always include a presentation of the findings of a core outcome set, as a minimum. (bmj.com)
  • Secondary outcomes were mean Edinburgh postnatal depression scale, clinical outcomes in routine evaluation-outcome measure (CORE-OM), state-trait anxiety inventory (STAI), SF-12, and parenting stress index short form (PSI-SF) scores at six, 12, 18 months. (bmj.com)
  • We briefly present a hierarchical framework that incorporates ideas from Prentice's work and is uniformly applicable to different types of surrogate and true clinical outcomes. (biomedsearch.com)
  • We evaluated MDR-TB treatment outcomes from a clinical cohort with task-sharing between a clinical nurse practitioner (CNP) and a medical officer (MO). (cdc.gov)
  • This study is a phase 4 trial evaluating the effect of obeticholic acid on clinical outcomes in patients with primary biliary cholangitis. (mdmercy.com)
  • New innovations must be assessed not only for the outcomes examined in clinical trials, but also for physician training requirements and system readiness. (ptca.org)
  • The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease. (stanford.edu)
  • Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Libert Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. (stanford.edu)
  • Parvizi J, Reines D, Steege J, Viscusi E. CSI: Investigating Acute Post-Operative Pain: Improved Outcomes and Clinical Horizons. (asahq.org)
  • Patient-reported outcomes should also be assessed to help redefine endpoints for I-O clinical trials and drive more efficient drug development. (aacrjournals.org)
  • As reported in The Lancet Oncology by Cella et al, patient-reported outcomes were better with nivolumab plus ipilimumab vs sunitinib in the phase III CheckMate 214 trial among patients with intermediate- or poor-risk advanced renal cell carcinoma. (ascopost.com)
  • Technology can deliver transition interventions to adolescents with diverse chronic illnesses, and a generic approach offers a cost-effective means of positively influencing transition outcomes. (aappublications.org)
  • More than another clinical landmark for translational science in gene therapy, the approval of Zolgensma provides hope for thousands of families affected by SMA in the United States," Guangping Gao, Ph.D., President of the American Society of Gene and Cell Therapy and director of the Horae Gene Therapy Center at the University of Massachusetts Medical School says. (bio-medicine.org)
  • A number of these small-molecule inhibitors, such as analogs of MI-219 and Nutlin-3, have progressed to advanced preclinical development or early phase clinical trials. (nih.gov)
  • She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association-Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. (wiley.com)
  • Recruitment, enrollment and retention trials f. (nih.gov)
  • LONDON, ONTARIO - January 17, 2019 - Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova's Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes. (researchpark.ca)
  • Penned by Associate Editor J. Dawn Abbott, MD, the article, titled " Diffusion of Innovations and Adoption of Transradial Intervention ," explores why it has taken so long (and continues to) for the transradial approach to be adopted widely in the U.S., given that the evidence from clinical trials has been clear, and that the economic and patient comfort benefits are evident. (ptca.org)
  • the transradial approach is now being used more than 15% of the time in the U.S. (I keep specifying "the United States," because in the rest of the world, TRI has been used far more frequently. (ptca.org)
  • So if anyone is interested in pursuing the transradial approach, we strongly urge you to attend one or more of the many courses available. (ptca.org)
  • Transradial Approach Surging in the U.S. (ptca.org)
  • If you currently utilize the transradial approach, make sure you are listed in our Transradial Hospital Locator . (ptca.org)
  • She also was an early adopter of the transradial approach and is a national expert on the topic. (stanford.edu)
  • Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science. (bmj.com)
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • Detailed illustrations with data from four clinical or epidemiologic studies are provided. (nih.gov)
  • These studies also may show which medical approaches work best for certain illnesses or groups of people. (nih.gov)
  • This guidance document provides you with information regarding clinical studies for devices used in spinal vertebral body augmentation for the purpose of treating insufficiency fractures of the spinal vertebral body due to minor trauma, osteoporosis, or other lytic conditions. (fda.gov)
  • As described in that guidance, in some instances FDA recommends clinical studies to support a new material or change to an existing formulation. (fda.gov)
  • The purpose of this guidance is to provide information related to clinical studies FDA may recommend in the support of premarket notification submissions (510(k)s) for these devices. (fda.gov)
  • Your physician may know of current clinical trial studies that are specific to your condition. (nationaljewish.org)
  • Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. (umassmed.edu)
  • Clinical studies have established that patients can experience fewer complications and faster recovery when acute post-operative pain is actively managed. (asahq.org)
  • Clinical studies have established that patients can experience fewer complications and faster recovery when acute post-operative pain is treated aggressively. (asahq.org)
  • Stage 2 included two steps: clinical studies to "assess and prioritize the biomarkers based on their relationship to clinical disease activity" followed by a study to verify that the MBDA would reflect joint findings. (managedcaremag.com)
  • Sign up for Insight Alerts highlighting editor-chosen studies with the greatest impact on clinical care. (aappublications.org)
  • We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. (europa.eu)
  • Whereas using several trials overcomes some of the limitations of a single-trial framework (Prentice, 1989, Statistics in Medicine 8, 431-440), arguably the evaluation of surrogate endpoints can never be done using only statistical evidence but such evidence should be seen as but one component in a decision-making process that involves, among others, a number of clinical and biological considerations. (biomedsearch.com)
  • See all articles in this CCR Focus section, "Clinical Trial Design Considerations in the Immuno-oncology Era. (aacrjournals.org)
  • Gene transfer approaches, also called gene addition, restore the missing function of a faulty or missing gene by adding a new gene to affected cells. (nih.gov)
  • Zolgensma (Novartis, AveXis), an AAV-delivered gene therapy used to treat spinal muscular atrophy (SMA) also known as AVXS-101, was approved for clinical use in the United States by the Food and Drug Administration today. (bio-medicine.org)
  • Many experimental gene-therapy approaches are based on repairing or replacing defective p53 genes. (asbestos.com)
  • Gene therapy is a hot topic in Parkinson's disease. (michaeljfox.org)
  • With support from MJFF, Phase I trials showed the gene therapy was safe and well-tolerated for up to three years in 15 people who had Parkinson's for an average of 10 years. (michaeljfox.org)
  • Another approach to exploit P-gp is represented by ABCB1 gene transfer to transform bone marrow progenitor cells into a drug resistant state which may allow conventional or higher doses of anticancer drug substrates of P-gp to be administered safely after transplantation. (frontiersin.org)
  • This is an RT-PCR based approach that subdivides a bulk T cell population (i. e. from blood, lymph, spleen, or tissue) into approximately 2800 groups based upon rearranged variable beta (V beta) / joining beta (J beta) gene segments and the resulting length of the T cell receptor (TCR) third complementarity determining region (CDR-3). (eurekaselect.com)
  • Our overall goal was to summarize the evidence-base on what is safe and effective when it comes to complementary approaches for pain. (nih.gov)
  • Providers need more high quality information on the evidence base for pain management tools, especially nondrug approaches. (nih.gov)
  • Critical to this approach is an honest consideration of the scientific evidence. (sciencebasedmedicine.org)
  • However, that evidence must be informed by a consideration of basic scientific principles, and the overall scientific evidence established on a topic. (sciencebasedmedicine.org)
  • But the totality of the evidence, when considered in the context of what we know to be a fact in fields like physics, biochemistry and other disciplines, makes it far more likely that positive effects seen in any single trial are due to bias, poor design, or statistical noise. (sciencebasedmedicine.org)
  • The Institute of Medicine provided the current definition of CER as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. (ajnr.org)
  • The current management of Alzheimer's disease is reviewed and it involves a multidisciplinary approach. (prnewswire.com)
  • Therefore, there is a growing interest in the relation between Nrf2 and disease and the identification of novel approaches targeting Nrf2 pathway to prevent and/or retard tissue injury. (frontiersin.org)
  • A novel approach using electrical stimulation to treat Parkinson's disease is now available. (managedcaremag.com)
  • Therefore, inhibiting the activity of these enzymes has surfaced as one of the major disease-modifying approaches for AD [ 4 ]. (hindawi.com)
  • Outlines opportunities and challenges presented by emerging technologies and approaches toward acceleration of drug development and toxicity testing. (rti.org)
  • This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. (wiley.com)
  • Clinical decision support systems (CDSS) are being applied widely in patient safety, most frequently to provide alerts intended to prevent medication errors . (ahrq.gov)
  • Ignacio Duran, MD, PhD, of the Hospital Universitario Marqués de Valdecilla, discusses an overall survival analysis of the phase III METEOR trial of cabozantinib vs everolimus in advanced renal cell carcinoma (Abstract 550). (ascopost.com)
  • Cardiac troponin assays: guide to understanding analytical characteristics and their impact on clinical care. (springer.com)
  • Summarize key guideline recommendations regarding multimodal approaches to post-operative analgesia. (asahq.org)
  • This topic review will summarize the major clinical trials that have focused on the gastroduodenal protective effects of the COX-2 inhibitors as compared to nonselective NSAIDs. (uptodate.com)
  • Intervention Health visitors (n=89 63 clusters) were trained to identify depressive symptoms at six to eight weeks postnatally using the Edinburgh postnatal depression scale (EPDS) and clinical assessment and also trained in providing psychologically informed sessions based on cognitive behavioural or person centred principles for an hour a week for eight weeks. (bmj.com)
  • The subsequent larger trial should have the potential to make a significant impact on public health. (nih.gov)
  • Clinical trials produce the best data available for health care decisionmaking. (nih.gov)
  • The National Heart, Lung, and Blood Institute (NHLBI) and other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. (nih.gov)
  • These approaches vary by disorder and are specific to an individual's health needs. (medlineplus.gov)
  • ClinicalTrials.gov , a service of the National Institutes of Health, provides easy access to information on clinical trials. (medlineplus.gov)
  • Are there new approaches to help us better monitor the health of the fetus in utero? (google.com)
  • How do I get involved in clinical trials at National Jewish Health? (nationaljewish.org)
  • Many medications have been introduced to the marketplace as a direct result of the clinical trial work performed at National Jewish Health. (nationaljewish.org)
  • Sleeping sickness is a double-pronged threat to health and well-being in Africa, and we are honored to have the opportunity to share our exciting new approach with those individuals from around the globe who are most committed to finding solutions," said Mr. Bellenson. (drugs.com)
  • As a result, many people may turn to complementary health approaches to help manage their pain. (nih.gov)
  • One of the major aims is to build effective collaborations between academia, clinical/public health sector and private companies, as well as across national borders. (debra-international.org)
  • Controls received mailed materials on general health topics. (aappublications.org)
  • We examine current financial crises and managerial problems in health care along with alternative ways to remedy them- and also to advance both financial and clinical accountability for equitable and affordable care. (bu.edu)