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
Influenza A Virus, H1N1 Subtype Infections Global Clinical Trials Review, H2, 2016 by type, trend, region, Forecasts |...Before It's News). Publisher's clinical trial report, "Influenza A Virus, H1N1 Subtype Infections Global Clinical Trials Review, H2, 2016″ provides an overview of Influenza A Virus, H1N1 Subtype Infections clinical trials scenario. This report provides top line data relating to the clinical trials on Influenza A Virus, H1N1 Subtype Infections. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). Publisher Clinical Trial Reports are generated using Publisher's proprietary database - Pharma eTrack ...
Research on Clinical Trials. Clinical trials in developing countries and Swissmedic s role in protecting vulnerable...Research on Clinical Trials Clinical trials in developing countries and Swissmedic s role in protecting vulnerable participants 2 The Berne Declaration Founded in 1968, the Berne Declaration (BD) is an
What is a Clinical Trial? | Cancer 101Cancer clinical trials are no longer seen as a last resort for cancer patients who had no other treatment choices. Today, patients often choose to receive their first cancer treatment in a clinical trial for many reasons.. First, cancer patients who take part in a trial may be helped by the treatment they receive. Trial participants receive either the standard of care-what scientists consider the most effective known treatment available-or the new medication or procedure under study. Cancer trial participants have access to the latest drugs, procedures, and other types of treatment. Although there is no guarantee that a new treatment will be effective, many trial participants conclude that the possible benefits outweigh the risks. But if a new treatment is effective, patients in clinical trials are among the first to receive it.. Second, clinical trials contribute to the overall knowledge ...
Could ecstasy help victims of child abuse, rape and crime? Doctors get go-ahead for first clinical trial | Daily Mail OnlineScientists believe that ecstasy and other illegal drugs like LSD and magic mushrooms are potentially useful in treating people with serious psychological issues.
Onconova Presents Positive Clinical Trial Results for Radiation Injury Protector Ex-RAD - Drugs.com MedNewsData Assessing Safety and Bioavailability of Oral and Subcutaneous Formulations to be presented at the Annual Meeting of Oct 3, 2012 - Onconova Therapeutics, In
Wanted: Hominids for Clinical Drug Trialshere). They propose that our ancestors lost their Siglecs some time after our lineage branched off from that of chimpanzees about six million years ago. The scientist also suggest that when the Siglecs disappeared, our lineage became prone to damaging overreactions from T cells that other apes did not suffer.. Why would natural selection favor Siglec-free T cells in the face of these diseases? It's possible that our ancestors faced some awful pathogen that required a powerful T cell response. Perhaps this reaction even helped our ancestors spread to new environments where they faced new disease.. It's also possible that natural selection had nothing to do with it. The diseases associated with the overactive human T cell take a long time to develop, and so they may not have interfered with child bearing-and thus with passing on genes from generation to generation.. There's one particularly intriguing coincidence to consider here: sialic acids have clearly undergone a dramatic evolutionary change ...
June, 2011 | Work In ProgressYesterday, the Oncologic Drugs Advisory Committee issued its recommendation to the FDA on the use of Avastin for the treatment of breast cancer: no. Based on clinical trial results, ODAC members voted unanimously that the. ...
Clinical trial will test controlled 'drug holidays' to c...( Researchers have received approval fo...)...Researchers have received approval for a new clinical trial to test c...Current state-of-the-art therapy for HIV infection is to administer a...Researchers at The Wistar Institute and elsewhere believe that carefu... Many people feel that the answer to AIDS will be found in improved a...,Clinical,trial,will,test,controlled,'drug,holidays',to,counter,HIV,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
DMOZ - Health: Nursing: Specialties: OncologyWide range of information organized for the patient, health professional and basic researcher, including the PDQ database with treatment information, and clinical trial information, from the National Cancer Institute. ...
Clinical Trials | Coliseum Health SystemClinical Trials - Clinical trials are research studies designed to evaluate new cancer treatment options, including new drugs, surgical approaches, radiation therapies...
AG | Volunteer for a Clinical TrialWe regularly conduct clinical trials of new and promising alternatives to standard gastrointestinal procedures for a wide variety of conditions. Discover the benefits of participation in a clinical trial.
Using the Patient's Immune System to Treat One of the Deadliest Cancers | WBFFPancreatic cancer is a deadly disease that presents unique challenges for researchers. Clinical trials at Huntsman Cancer Institute (HCI) are testing immunotherapy, medicines that stimulate the patient's immune system, to boost the effects of standard chem
Study to test new tinnitus 'treatment' - The University of NottinghamA new clinical trial is to test whether a pocket-sized device that uses sound simulation to reboot faulty 'wiring' in the brain could cure people with tinnitus.
Transcept Pharmaceuticals Announces that a Phase 2 Clinical Trial of TO-2061 as Adjunctive TherapyPOINT RICHMOND, Calif., Dec. 21, 2012 /PRNewswire/ -- Transcept Pharmaceuticals Announces that a Phase 2 Clinical Trial of TO-2061 as Adjunctive Therapy...
Clinical Trials Significantly Enhanced With RxPense HubMONTREAL, June 14, 2016 /PRNewswire/ -- Clinical Trials Significantly Enhanced With RxPense Hub. RxPense®, an intelligent and connected medication...
Melt-Away Stent Works Well in Trial ( Absorbed harmlessly in the body it co...)Health,...Absorbed harmlessly in the body it could replace traditional metal st...THURSDAY March 13 (HealthDay News) -- A polymer stent that is quietly...The stent was successfully implanted in 29 of 31 attempts the report ...A major clinical trial of the experimental stent is under way in sever...,Melt-Away,Stent,Works,Well,in,Trial,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid... ( ...)Health,... ... ... ... ...,Lexicon,Initiates,Phase,2,Clinical,Trial,of,LX2931,in,Patients,With,Rheumatoid,Arthritis,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK...This study is investigating the combination regimen of MK-5172 and MK-3682 with either MK-8742 or MK-8408 in patients with chronic HCV GT1, GT2 and GT3
AG | Our ResearchWe regularly conduct clinical trials of new and promising alternatives to standard gastrointestinal procedures for a wide variety of conditions. Discover the benefits of participation in a clinical trial.
Clinical Trial Supply ManagementMeet World leaders and experts in advancing clinical and medical imaging to estimate disease prevalence utilizing imaging technologies.
Innovations in Clinical TrialsMeet World leaders and experts in advancing clinical and medical imaging to estimate disease prevalence utilizing imaging technologies.
CRO, Clinical Trial Services, Pharmaceutical Consulting - QuintilesIMSLearn how Quintiles can improve your probability of success by driving predictable and effective delivery for clinical, commercial, and real-world value.
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FDA Approves Allergan's sNDA for AVYCAZ® (ceftazidime and avibactam) to include new Phase III dataDUBLIN, Jan. 30, 2017 /PRNewswire/ -- FDA Approves Allergan's sNDA for AVYCAZ® (ceftazidime and avibactam) to include new Phase III data in Patients with...
Pivotal Phase III Data Confirm the Efficacy and Safety of Arpida's Intravenous Iclaprim in Treating Patients With Complicated...... Iclaprim also achieved high eradication rates for the most common...REINACH Switzerland Oct. 26 /- Arpida (SWX:A...Iclaprim a novel antibiotic from the trusted dihydrofolate reductase... The high efficacy rates and favorable tolerability profile of iclapri...,Pivotal,Phase,III,Data,Confirm,the,Efficacy,and,Safety,of,Arpida's,Intravenous,Iclaprim,in,Treating,Patients,With,Complicated,Skin,and,Skin,Structure,Infections,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Novartis announces NEJM publication of two pivotal Phase III secukinumab studies - Drugs.com MedNewsEAST HANOVER, N.J., July 9, 2014 Novartis today announced that The New England Journal of Medicine (NEJM) published the results from two pivotal Phase III studi
Zogenix Initiates Pivotal Phase 3 Clinical Trial for Novel Formulation of Oral Controlled-Release H... ( SAN DIEGO Mar We...... SAN DIEGO Mar... We are pleased to be initiating this pivotal Phase 3 trial of ZX002 a...,Zogenix,Initiates,Pivotal,Phase,3,Clinical,Trial,for,Novel,Formulation,of,Oral,Controlled-Release,Hydrocodone,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non...Nachricht: AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis at the American Society for - 19.10.16 - News
Aurinia Announces Plans for Single Phase III Clinical Trial for Voclosporin in the Treatment of Lupus Nephritis Following...Aurinia Pharmaceuticals Inc. (NASDAQ AUPH) (TSX AUP) ( Aurinia or the Company ), today announced its plans for a single Phase III clinical trial for voclosporin
Neothetics Announces Last Patient Enrolled in LIPO-202 Pivotal Phase 3 Clinical Trials for Reduction of Subcutaneous Abdominal...Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2. The...
A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV)...To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy w
A Multi-center, Randomized, Double-blind, Placebo Parallel controlled, Standard Therapy Based Phase III Clinical Trial to...This trial will investigate the efficacy of recombinant human neuregulin 1 beta in patients with chronic heart failure. The primary endpoint is cardiac function
Battening The Hatches | December 6, 2010 Issue - Vol. 88 Issue 49 | Chemical & Engineering NewsLilly CEO John C. Lechleiter acknowledged setbacks such as the failure in Phase III clinical trials of teplizumab, a diabetes treatment the company was developing with MacroGenics, and the halted clinical trials for two Alzheimer's disease drugs. Lechleiter claimed, however, that the company is on track for growth, pointing to cost-cutting efforts and strong international sales. "Japan performed particularly well in the quarter, growing revenue by 27%, driven by recent product launches. Strong performance was also seen in key emerging-market countries," he said. Sales were up 1.7% for the quarter and 6.2% for the first nine months, compared with 2009.. ...
Kowa Announces Subgroup Analyses of Peretinoin (NIK-333) Phase II/III Trial in Patients Following Curative Therapy for...Peretinoin may reduce de novo carcinogenesis Presented at American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2011 Jan 24, 2011 - Kowa Comp
INTERNEURON'S STROKE DRUG BEGINS PHASE II/III TRIALS | BioWorldBioWorld Online is the news service of record for the biotechnology industry and is updated every business morning. BioWorld Online will keep you up to date on all of the industry's business, science and regulatory news -- mergers and collaborations, FDA hearings and results, breakthroughs in research and much more.
Can a doctor suggest a good treatment for painful ankle and joints due to slipping from staircase ? - Doctor's insight on...Question - Can a doctor suggest a good treatment for painful ankle and joints due to slipping from staircase ?. Ask a Doctor about when and why MRI is advised, Ask an Orthopaedic Surgeon
Determinants of virological failure after 1 year's antiretroviral therapy in Vietnamese people with HIV: findings from a...Results Only 63% (2010/3199) of patients had access to routine viral load testing after 1 year of ART. After adjusting for other factors, patients with a baseline CD4 count of 50-100, 101-200 and 201-350 cells/mm3 were 0.48 (95% CI 0.20 to 0.74), 0.63 (95% CI 0.23 to 0.82) and 0.73 times (95% CI 0.14 to 0.95) as likely to have virological failure, respectively, as those with a baseline CD4 count ,50 cells/mm3. After adjusting for other factors, patients with good treatment adherence were 0.54 times as likely to have viraemia as those with poor treatment adherence (95% CI 0.28 to 0.81) and patients with immunological failure were 1.43 times as likely to have viraemia (95% CI 1.31 to 1.65) as those without. The PPV of immunological criteria was 60.1% (95% CI 57.1% to 69.3%).. ...
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir...This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of elbasvir (50 mg)/grazoprevir (100 mg)
Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and...This trial evaluated the efficacy of intravenous loading doses of ibandronic acid in patients with non-small cell lung cancer and skeletal metastases
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer - Full...PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used ...
An 18 Month Open Label Study Of The Tolerability And Efficacy Of An Antisense Oligonucleotide In Patients With Wild-Type...The aim of the study is to determine whether lowering the blood levels of TTR, by a weekly injection of ISIS-TTRrx [Isis 420915/GSK 299872] will slow the
Articles about Belviq, Arena Pharma, Etc.Arena had a classic case of Founder's Syndrome where the challenge gets too big for a founder. A lot of people helped it get FDA approval on its very important drug, Belviq despite attempts by some short sellers to dissuade FDA against its approval despite the very clean safety and good efficacy of Belviq, the obesity pandemic, and proof that diet and exercise alone don't work in most cases because of the changes in the brain and metabolism of obese people - and it can lead to some 50 diseases (as per Dr. Aronne, a top specialist).. Belviq's excellent safety and efficacy can be summarized as follows (with full details on belviq.com).. · In clinical trials, patients on Belviq had a 10.6 to 1 odds of losing weight versus quitting due to adverse side effects. (1 out of 10.6 patients quit), while Contrave had a 2 to 1 ratio of success to side effects related discontinuation (1 out of 2 patients quit). So Belviq is far more tolerable and has milder side effects. Its most common ...
A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With...The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or
OPSITE Post-Op post-operative dressings from Smith & Nephew | Smith & Nephew - CorporateOPSITE Post-Op and OPSITE Post-Op Visible both meet the criteria for an ideal post-operative dressing and provide several important benefits
What We DoThe CEBM is a not-for-profit organisation dedicated to the practice, teaching and dissemination of high quality evidence based medicine to improve healthcare in everyday clinical practice.. Research. One of our objectives is to produce high quality research capable of changing or improving current clinical practice. We use a variety of methods to achieve this including carrying out clinical trials, conducting systematic reviews, qualitative work, theoretical modelling, database analysis and quantitative analysis. We currently have several project themes led by various members of CEBM. Examples of some of our active research themes include research into Non-Communicable Disease which includes a research collaboration with the World Health Organisation. We also have a strong Diagnostic theme which includes assessing novel Diagnostic Technologies relevant to improving the diagnosis of disease in primary care.. One of the core objectives of each ...
Plus itThe aim of drug regulation is to ensure that only effective and safe treatments reach patients. Ideally, regulatory decisions are based on good quality data from large trials measuring real world, patient centred outcomes. Licensing agencies, however, routinely approve treatments on the basis of small placebo controlled trials evaluating short term, surrogate endpoints in selected populations. Consequently, medicines are commonly prescribed without good quality data on their long term benefits and harms.1 2 Current licensing standards are inadequate to predict the real world therapeutic value of new medications.3. This is particularly problematic for preventive treatments given to large populations, which should be subject to a high standard of proof of benefit and absence of appreciable harm. These drugs present interesting challenges because, firstly, the real world benefits often take many years to arise and, secondly, those benefits are often modest, although ...
Intervention Steps and Best Practices - Alcohol RehabStage four is the pre-intervention meeting. It is during this time that the interventionist will discuss in detail who will be attending, where and when the event is going to take place, who will speak and for how long, and what they will say. A fool-proof plan will ensure that all possible outcomes have been considered, and will mean a stronger intervention. It is also during this time that the interventionist may suggest each member writes a letter to the client. This letter is to be read to the alcoholic to show them how their behavior is affecting others. It is done to give them a picture of how they are not just destroying themselves, but also those who care about them. The letter should be succinct and comprehensively detail how the person cares about them, are scared for them, and how they want to help them on their road to recovery. By writing a letter, it ensures that each person can clearly say what they want without being distracted by the emotions of the intervention.. ...
Sebelipase alfa Side Effects in Detail - Drugs.comLearn about the potential side effects of sebelipase alfa. Includes common and rare side effects information for consumers and healthcare professionals.
A prospective phase I and consecutive phase II, two arm, randomized multi-center trial of temsirolimus in combination with...This trial will investigate the efficacy and tolerability of temsirolimus in combination with pioglitazone, etoricoxib, trofosfamide versus dacarbazine in
Rayos Side Effects in Detail - Drugs.comLearn about the potential side effects of Rayos (prednisone). Includes common and rare side effects information for consumers and healthcare professionals.
Aredia Side Effects in Detail - Drugs.comLearn about the potential side effects of Aredia (pamidronate). Includes common and rare side effects information for consumers and healthcare professionals.
Follicle stimulating hormone Side Effects in Detail - Drugs.comLearn about the potential side effects of follicle stimulating hormone. Includes common and rare side effects information for consumers and healthcare professionals.
Excedrin Back & Body Side Effects in Detail - Drugs.comLearn about the potential side effects of Excedrin Back & Body (acetaminophen/aspirin). Includes common and rare side effects information for consumers and healthcare professionals.
Remifentanil Side Effects in Detail - Drugs.comLearn about the potential side effects of remifentanil. Includes common and rare side effects information for consumers and healthcare professionals.
Instacort Side Effects in Detail - Drugs.comLearn about the potential side effects of Instacort (hydrocortisone). Includes common and rare side effects information for consumers and healthcare professionals.
Tempra 2 Side Effects in Detail - Drugs.comLearn about the potential side effects of Tempra 2 (acetaminophen). Includes common and rare side effects information for consumers and healthcare professionals.
Solfoton Side Effects in Detail - Drugs.comLearn about the potential side effects of Solfoton (phenobarbital). Includes common and rare side effects information for consumers and healthcare professionals.
AH-Chew D Side Effects in Detail - Drugs.comLearn about the potential side effects of AH-Chew D (phenylephrine). Includes common and rare side effects information for consumers and healthcare professionals.
Adeno-jec Side Effects in Detail - Drugs.comLearn about the potential side effects of Adeno-jec (adenosine). Includes common and rare side effects information for consumers and healthcare professionals.
Egrifta Side Effects in Detail - Drugs.comLearn about the potential side effects of Egrifta (tesamorelin). Includes common and rare side effects information for consumers and healthcare professionals.
Iopidine Side Effects in Detail - Drugs.comLearn about the potential side effects of Iopidine (apraclonidine). Includes common and rare side effects information for consumers and healthcare professionals.
Netromycin Side Effects in Detail - Drugs.comLearn about the potential side effects of Netromycin (netilmicin). Includes common and rare side effects information for consumers and healthcare professionals.
Levoxyl... is a prescription drug that can treat an underactive thyroid and certain types of thyroid problems. This eMedTV page offers an overview of the drug, including information on how it works, potential side effects, and some general precautions.
Phase I/II Study to Evaluate the Safety and Tolerability of Avelumab in Combination With Other Anti-Cancer Therapies in...Objectives: Primary Objectives: - For Arms C-G, to establish the safety, tolerability, and dose-limiting toxicities (DLTs) of different treatment combinations
surgeryThe patients, who have suffered a surgical intervention by an experienced surgeon, have a rate of mortality on long term with 22% inferior to those who have been treated by surgeons with a lower volume of surgical interventions in their list of achievements.. According to which criteria should one chose his/her doctor or surgeon in case of a relatively severe disease? The experience is an important factor of the doctorÂ´s quality. A new proof has been given by Swedish researchers who have substantiated that a patient suffering of oesophagus cancer benefits from a longer survival on long term if he/she has been operated on by an experienced surgeon, who has the experience of such difficult interventions, in comparison with a novice or a doctor not specialized in this pathology. As one could have suspected, they have substantiated it in a masterly manner. The researchers at the Institut Karolinska, who have published their result on the 7th of January in The Journal of Clinical Oncology , ...
outcome - Symptoms, Treatments and Resources for outcomeoutcome - MedHelp's outcome Center for Information, Symptoms, Resources, Treatments and Tools for outcome. Find outcome information, treatments for outcome and outcome symptoms.
Oxygen For Life... - Our purpose is to facilitate the global improvement of the health and well-being of humans, plants and animals. By providing advanced natural oxygenating products, together with informed service and purposeful education, we work at enhancing the existence of the Earths inhabitants purifying all sources of water and waste; and improving the productivity of our soils, for the general upliftment of mankind.
Improving Drug Treatments In MammalsAn improved method for identifying the size, shape and duration of drug exposure necessary to improve drug treatment in a subject with a bacterial infection. In addition, an improved method for identification of new dosing strategies which optimize the probability of positive treatment outcomes in subjects using resistance inhibitory concentration
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and...This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line
CardioMessenger Smart, a Device for Early Therapy Adjustments in Heart PatientsThe device is fully automatic, passing the data through the GSM cellular network to physicians without any interaction from the patients.
A 12-month Open-label Study To Evaluate The Safety And Tolerability Of Pregabalin As Adjunctive Therapy In Pediatric Subjects 1...This study is investigating the efficacy, long-term safety and tolerability of pregabalin as add-on therapy in paediatric patients aged 1 month to 16 years with
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated...This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC,
First thoughts on Kin One and Two from teen reviewers | ZDNetIn order to help you understand if the new Microsoft Kin One and Two devices are an attractive option for teenagers I am having my two teen daughters evaluate the devices.
How fast growing cancer cells?; The tumor; Course of the cancer process; Doubling Time; Growth of the tumor; UitzaaïngenIn healthy tissue cells often go lost, and it is of the utmost importance that is compensated for by the process of cell division, this loss of cells. If we are talking about a cancer, we
Conditions & Procedures | Nutrition | Functional MedicineNutrition is of the utmost importance for your health. They say you are what you eat and that is very true. Learn more at Top10MD.
Mayor Hospitalized With Chest Pains - tribunedigital-chicagotribuneMayor Richard Sarallo was listed in stable condition in the cardiac care unit of Hinsdale Hospital after suffering chest pains Thursday morning, hospital officials said.According to city officials,
Abstinence-The Only Way to Beat Addiction? Part 1 | Psychology TodaySome who struggle with addiction aren't ready to commit to abstinence, yet they're aware of their problem and want help. However, most treatment facilities require abstinence and see it as the only acceptable outcome. In fact, many of them will kick clients out of treatment for the very symptoms of their disorder-that is, using drugs or alcohol.
The Advisor's Guide to Succession Planning - AdvisorAnalyst.comHere, I've compiled a brief advisor's guide to succession planning. It will give you a starting point, including questions you should be asking as you prepare for the next phase of your business and your life.. This question may seem obvious at first glance, but it's actually one of the most critical components of any succession plan-and perhaps the most difficult to grapple with. After all, you've spent countless hours, days, and years building a successful practice. Are you really ready to move onto the next phase of your life? Here, it's important to keep in mind that even if you decide to step down from handling the major wealth management responsibilities, there are options for you to stay involved in other aspects of your practice and continue to be compensated. If you feel you might miss being in the role of rainmaker, for example, a toe-in-the-water approach might work for you.. Don't be surprised if you have a hard time answering this question! Talking it out with those whom you trust ...
CorporateBe a part of a select group of member companies that are engaged in exploring or doing business globally. Membership provides networking tools to help you be more successful in the complex global business environment while raising global awareness in our community.. Join/Renew Now. Global Community Building Corporate Partner Focus Options:. ...
Can a Beast Implant Get Hard, Swollen and Painful but Correct Itself over a Two Week Period? Doctor Answers, TipsThe presentation of the swelling and it getting resolved by itself is not due to the infection. Your surgeon can examine you and give you better answer...
Outlining My Wrestlemania XXVI Review | Bleacher ReportFirst of all, this isn't going to be any ordinary review. This is going to be a very in-depth review which will analyse the match, the outcome, reasons for the outcome and where the result will lead to in my opinion...
Electrical Burns In Adults - What You Need to KnowCare guide for Electrical Burns In Adults. Includes: possible causes, signs and symptoms, standard treatment options and means of care and support.
Institute of Cancer Research Repository - Baseline Circulating Tumor Cell Counts Significantly Enhance a Prognostic Score for...Background: High circulating tumor cell (CTC) counts are associated with poor prognosis in several cancers. Enrollment of patients on phase I oncology trials requires a careful assessment of the potential risks and benefits. Many patients enrolled on such trials using established eligibility criteria have a short life expectancy and are less likely to benefit from trial participation. We hypothesized that the incorporation of CTC counts might improve patient selection for phase I trials. Methods: This retrospective analysis evaluated patients who had baseline CTCs enumerated prior to their starting on a phase I trial. CTCs were enumerated using the CellSearch System. Results: Between January 2006 and December 2009 a total of 128 patients enrolled in phase I trials had CTC counts evaluated. Higher CTC counts as a continuous variable independently correlated with risk of death in this patient population (P = 0.006). A multivariate point-based ...
Successful Phase I/II Clinical Trial Results From Cancer Patients Treated With Anti-Cancer Drug From... ( STOCKHOLM May 6 /...... STOCKHOLM May 6 /- Axelar AB today announced success... The ongoing phase I/II clinical trial is primarily designed to ass... We are very pleased that high doses of AXL1717 could be administe... The IGF-1 receptor is a promising target for the treatment of canc...,Successful,Phase,I/II,Clinical,Trial,Results,From,Cancer,Patients,Treated,With,Anti-Cancer,Drug,From,Axelar,AB,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
Institute of Cancer Research Repository - First-line Epidermal Growth Factor Receptor (EGFR) Kinase Inhibitors for EGFR Mutant...ISI Document Delivery No.: EI6ZZ Times Cited: 0 Cited Reference Count: 31 Juan, O. Yousaf, N. Popat, S. NHS O. Juan acknowledges the Spanish Society of Medical Oncology (SEOM) and the CRIS Cancer foundation to support the collaboration with the Royal Marsden Hospital. S. Popat and N. Yousaf acknowledge NHS funding to the Royal Marsden Hospital NIHR-Biomedical Research Centre. 0 ELSEVIER SCIENCE LONDON LONDON CLIN ONCOL- ...
Cancer Care Series - Pediatric Oncology | MD Anderson Cancer CenterChildhood cancer was almost always fatal before 1970. Today, 80% of children diagnosed with cancer will survive at least 5 years; 70% will be cured. However, cancer continues to be the leading cause of nonaccident-related deaths in children. More children die each year from cancer than from cystic fibrosis, diabetes, asthma, AIDS, and congenital abnormalities combined. Nine children die from cancer every school day.. Despite the fact that pediatric cancers account for only a small percentage of the total cancer burden, more effective therapies are needed to improve mortality rates in children. Therefore, our research priority must be the development of new agents and new therapies for childhood cancer.. MD Anderson Cancer Center has been caring for children with cancer since its doors opened over 60 years ago. This institution has been home to several research and clinical pioneers whose innovative work has influenced and shaped the practice of pediatric oncology throughout the world. ...
Services and Multidisciplinary Units | MD Anderson Cancer Center MadridFurthermore, there is a solid, continuous relationship between the professionals at MD Anderson Madrid and those at MD Anderson in Houston, sharing protocols for the more complex cases in clinical sessions. This multidisciplinary approach to cancer allows a team of specialists to work together to ensure the best possible treatment for each patient. ...
DMOZ - Health: Conditions and Diseases: Cardiovascular Disorders: Vascular Disorders: AtherosclerosisBaylor College of Medicine has a research and clinical trials program exploring the effectiveness of medications and other therapies in causing stabilization or regression of atherosclerotic plaques in arteries. ...
Christine Habib, MDOhioHealth is now a certified member of MD Anderson Cancer Network ®- a program of MD Anderson Cancer Center - a world-renowned leader in cancer care. The OhioHealth collaboration with MD Anderson Cancer Network allows us to combine the best of what we provide locally with the expertise of one of the nation's leading cancer hospitals so we can better serve you ...
Colonoscopy | MD Anderson Cancer Center MadridThe process involves a previous preparation based on feces cleansing from the intestinal tract to be examined. By taking evacuant drugs (e.g., Bohm solution) and administration of cleansing enemas, if the condition requires it when the above is not effective, or is not tolerated by the patient and can lead to nausea and vomiting after intake. On the day before the test, the patient should take a diet based on liquids such as broths, juice, shakes, infusions, and water. Request the preparation protocol from your nurse ...
myCancerConnection PIKNIC- Coping with the fear of recurrence - MD Anderson Cancer CenterPIKNIC is a program of myCancerConnection in the Department of Volunteer Services and Merchandising. Date: 6/13/17, 12:30pm to 1: ...
On the use of generalized linear models following a sequential designDownloadable (with restrictions)! We provide conditions for the asymptotic normality of regression parameters from a generalized linear model, following a sequential design. Applications include sequential designs based on a generalized Friedman's urn for randomized clinical trials and a quadratic regression model.
7 Essential Cabinet Design Considerations for Protecting 19″ Electronics | Medical, eHealth & Home HealthThis white paper, written by Vlad Konopelko, Product Marketing Manager, North America, for Pentair's Schroff brand, introduces seven essential mechanical structure and protection standards and design considerations for specifying a reliable 19
Tipi di Disegno di Studio - ppt scaricareObjectives To understand the difference between descriptive and analytic studies To identify the hierarchy of study designs, and the strengths and weakness of each design To be able to apply different study designs to the same research question
On Purity | Deep thoughts and sillinessHaha. Just as a remark - not that I think you aren't aware of it - but what people often seem to overlook in that chain of reasoning is that one can't always draw conclusions about the larger system just from examining its constituents, emergent phenomena, complexity and all. Examples are plenty.. ...
FlexPod Datacenter with VMware vsphere 5.5 Update 1 Design Guide - PDFDatacenter with VMware vsphere 5.5 Update 1 Design Guide Last Updated: August 11, 2014 Building Architectures to Solve Business Problems 2 Cisco Validated Design About the Authors About the Authors John
Industrial Design Basics: Where to Start | Architecture & Design | Cadius.orgIndustrial Design (ID) or product architecture is the process of creating valuable, functional and aesthetically pleasing products for the benefit of both users
MA Typeface DesignThe MA Typeface Design was the first MA course in the field, and for a long time, the only one operating in a research-intensive university.
Community-based clinical trial: Community-based clinical trials are clinical trials conducted directly through doctors and clinics rather than academic research facilities. They are designed to be administered through primary care physicians, community health centers and local outpatient facilities.Placebo-controlled study: Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment.AIP Conference Proceedings: AIP Conference Proceedings is a serial published by the American Institute of Physics since 1970. It publishes the proceedings from various conferences of physics societies.Temporal analysis of products: Temporal Analysis of Products (TAP), (TAP-2), (TAP-3) is an experimental technique for studyingSampson Gideon: Sampson Gideon (February 1699 in London – 17 October 1762) was a Jewish-British banker in the City of London.TremelimumabBestbets: BestBETS (Best Evidence Topic Reports) is a system designed by emergency physicians at Manchester Royal Infirmary, UK. It was conceived as a way of allowing busy clinicians to solve real clinical problems using published evidence.British Journal of Diabetes and Vascular Disease: The British Journal of Diabetes and Vascular Disease is a peer-reviewed academic journal that publishes papers six times a year in the field of Cardiovascular medicine. The journal's editors are Clifford J Bailey (Aston University), Ian Campbell (Victoria Hospital) and Christoph Schindler (Dresden University of Technology).Antileukemic drug: Antileukemic drugs, anticancer drugs that are used to treat one or more types of leukemia, include:International Congress on Sleep ApneaList of Parliamentary constituencies in Kent: The ceremonial county of Kent,Combination therapy: Combination therapy or polytherapy is therapy that uses more than one medication or modality (versus monotherapy, which is any therapy taken alone). Typically, these terms refer to using multiple therapies to treat a single disease, and often all the therapies are pharmaceutical (although it can also involve non-medical therapy, such as the combination of medications and talk therapy to treat depression).Bio Base EuropeTime-trade-off: Time-Trade-Off (TTO) is a tool used in health economics to help determine the quality of life of a patient or group. The individual will be presented with a set of directions such as:Research participant: A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who participates in human subject research by being the target of observation by researchers.Systematic Protein Investigative Research EnvironmentClosed-ended question: A closed-ended question is a question format that limits respondents with a list of answer choices from which they must choose to answer the question.Dillman D.Online patient education: Online Patient Education also known as Online Patient Engagement is a method of providing medical information and education to patients using Learning Management Systems delivered through the Internet.Evaluation of bariatric Centers of Excellence Web sites for functionality and efficacy.Incremental cost-effectiveness ratio: The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect.National Clinical Guideline CentreAbscopal effect: The abscopal effect is a phenomenon in the treatment of metastatic cancer where localized treatment of a tumor causes not only a shrinking of the treated tumor but also a shrinking of tumors in different compartments from the treated tumor. Initially associated with single-tumor, localized radiation therapy, the term has also come to encompass other types of localized treatments such as electroporation and intra-tumoral injection of therapeutics.Low-dose chemotherapy: Low-dose chemotherapy is being studied/used in the treatment of cancer to avoid the side effects of conventional chemotherapy. Historically, oncologists have used the highest possible dose that the body can tolerate in order to kill as many cancer cells as possible.Surrogate endpoint: In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endnpoint as "a biomarker intended to substitute for a clinical endpoint".QRISK: QRISK2 (the most recent version of QRISK) is a prediction algorithm for cardiovascular disease (CVD) that uses traditional risk factors (age, systolic blood pressure, smoking status and ratio of total serum cholesterol to high-density lipoprotein cholesterol) together with body mass index, ethnicity, measures of deprivation, family history, chronic kidney disease, rheumatoid arthritis, atrial fibrillation, diabetes mellitus, and antihypertensive treatment.Concentration effect: In the study of inhaled anesthetics, the concentration effect is the increase in the rate that the Fa(alveolar concentration)/Fi(inspired concentration) ratio rises as the alveolar concentration of that gas is increased. In simple terms, the higher the concentration of gas administered, the faster the alveolar concentration of that gas approaches the inspired concentration.The Oxford Textbook of Medicine: The Oxford Textbook of Medicine Warrell DA, Cox TM, Firth JD. (2010).Osmotic controlled-release oral delivery system: OROS (Osmotic [Controlled] Release Oral [Delivery] System) is a controlled release oral drug delivery system in the form of a tablet. The tablet has a rigid water-permeable jacket with one or more laser drilled small holes.Generalizability theory: Generalizability theory, or G Theory, is a statistical framework for conceptualizing, investigating, and designing reliable observations. It is used to determine the reliability (i.Global Risks Report: The Global Risks Report is an annual study published by the World Economic Forum ahead of the Forum’s Annual Meeting in Davos, Switzerland. Based on the work of the Global Risk Network, the report describes changes occurring in the global risks landscape from year to year and identifies the global risks that could play a critical role in the upcoming year.European Society for Medical Oncology: ==About ESMO==Breast cancer classification: Breast cancer classification divides breast cancer into categories according to different schemes, each based on different criteria and serving a different purpose. The major categories are the histopathological type, the grade of the tumor, the stage of the tumor, and the expression of proteins and genes.Adverse event prediction: Adverse event (or Adverse effect) prediction is the process of identifying potential adverse events of an investigational drug before they actually occur in a clinical trial.Placebo studies: Placebo studies is an interdisciplinary academic discipline concerning the study of the placebo effect. The placebo effect is commonly characterized when patients given a placebo or "fake" treatment exhibit a perceived improvement.Patient participation: Patient participation, also called shared decision-making, is a process in which both the patient and physician contribute to the medical decision-making process. Under this operating system, health care providers explain treatments and alternatives to patients in order to provide the necessary resources for patients to choose the treatment option that most closely aligns with their unique cultural and personal beliefs.International Committee on Aeronautical Fatigue and Structural IntegrityFeasibility Study (The Outer Limits): "Feasibility Study" is an episode of The Outer Limits television show. It was first broadcast on 11 July 1997, during the third season.Dietary Supplements (database): The PubMed Dietary Supplement Subset (PMDSS) is a joint project between the National Institutes of Health (NIH) National Library of Medicine (NLM) and the NIH Office of Dietary Supplements (ODS). PMDSS is designed to help people search for academic journal articles related to dietary supplement literature.Tumor progression: Tumor progression is the third and last phase in tumor development. This phase is characterised by increased growth speed and invasiveness of the tumor cells.Pain scale: A pain scale measures a patient's pain intensity or other features. Pain scales are based on self-report, observational (behavioral), or physiological data.Pharmaceutical manufacturing: Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.Psychiatric interview: The psychiatric interview refers to the set of tools that a mental health worker (most times a psychiatrist or a psychologist but at times social workers or nurses) uses to complete a psychiatric assessment.Cancer survival rates: Cancer survival rates vary by the type of cancer, stage at diagnosis, treatment given and many other factors, including country. In general survival rates are improving, although more so for some cancers than others.Clinical endpoint: In a clinical research trial, a clinical endpoint generally refers to occurrence of a disease, symptom, sign or laboratory abnormality that constitutes one of the target outcomes of the trial, but may also refer to any such disease or sign that strongly motivates the withdrawal of that individual or entity from the trial, then often termed humane (clinical) endpoint.IontocaineMarketing authorization: Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), finalized by granting of a document also called marketing authorization (MA) (equivalent: product license).List of kanji by stroke count: This Kanji index method groups together the kanji that are written with the same number of strokes. Currently, there are 2,186 individual kanji listed.Management of HIV/AIDS: The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs in an attempt to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle.Exercise prescription software: Exercise prescription software is a branch of computer software designed to aid in the construction of exercise programmes or regimes for patients who require some kind of ongoing rehabilitation.Internet organizations: This is a list of Internet organizations, or organizations that play or played a key role in the evolution of the Internet by developing recommendations, standards, and technology; deploying infrastructure and services; and addressing other major issues.Cognitive behavioral treatment of eating disorders: Cognitive behavioral therapy (CBT) is derived from both the cognitive and behavioral schools of psychology and focuses on the alteration of thoughts and actions with the goal of treating various disorders. The cognitive behavioral treatment of eating disorders emphasizes the minimization of negative thoughts about body image and the act of eating, and attempts to alter negative and harmful behaviors that are involved in and perpetuate eating disorders.Biomarkers of aging: Biomarkers of aging are biomarkers that better predict functional capacity at a later age than chronological age. Stated another way, biomarkers of aging would give the true "biological age", which may be different from the chronological age.Monoclonal antibody therapyTargeted therapy of lung cancer: Targeted therapy of lung cancer refers to using agents specifically designed to selectively target molecular pathways responsible for, or that substantially drive, the malignant phenotype of lung cancer cells, and as a consequence of this (relative) selectivity, cause fewer toxic effects on normal cells.College of Practitioners of PhytotherapyInformation bias (epidemiology): Information bias}}
(1/13843) Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.
The assessment of symptom palliation is an essential component of many treatment comparisons in clinical trials, yet an extensive literature search revealed no consensus as to its precise definition, which could embrace relief of symptoms, time to their onset, duration, degree, as well as symptom control and prevention. In an attempt to assess the importance of these aspects and to compare different methods of analysis, we used one symptom (cough) from a patient self-assessment questionnaire (the Rotterdam Symptom Checklist) in a large (>300 patient) multicentre randomized clinical trial (conducted by the Medical Research Council Lung Cancer Working Party) of palliative chemotherapy in small-cell lung cancer. The regimens compared were a two-drug regimen (2D) and a four-drug regimen (4D). No differences were seen between the regimens in time of onset of palliation or its duration. The degree of palliation was strongly related to the initial severity: 90% of the patients with moderate or severe cough at baseline reported improvement, compared with only 53% of those with mild cough. Analyses using different landmark time points gave conflicting results: the 4D regimen was superior at 1 month and at 3 months, whereas at 2 months the 2D regimen appeared superior. When improvement at any time up to 3 months was considered, the 4D regimen showed a significant benefit (4D 79%, 2D 60%, P = 0.02). These findings emphasize the need for caution in interpreting results, and the importance of working towards a standard definition of symptom palliation. The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible. A standard definition of palliation for use in the analysis of clinical trials data is proposed, which takes into account aspects of onset, duration and degree of palliation, and symptom improvement, control and prevention. (+info)
(2/13843) Patterns of care and survival for adolescents and young adults with acute leukaemia--a population-based study.
We report a population-based study of patterns of care and survival for people with acute leukaemia diagnosed at age 15-29 years during 1984-94 in regions of England and Wales covered by specialist leukaemia registries. There were 879 patients: 417 with acute lymphoblastic leukaemia (ALL) and 462 with acute myeloid leukaemia (AML). For ALL, actuarial survival rates were 43% at 5 years after diagnosis and 37% at 10 years. Survival improved significantly between 1984-88 and 1989-94 for those aged 15-19 at diagnosis. Patients entered in national clinical trials and those not entered had similar survival rates. Survival rates were similar at teaching and non-teaching hospitals and at hospitals treating different numbers of study patients per year. For AML, survival rates were 42% at 5 years after diagnosis and 39% at 10 years. Survival improved significantly between 1984-88 and 1989-94. Patients entered in the Medical Research Council AML10 trial had a higher survival rate than those who were in the earlier AML9 trial. Survival did not vary with category of hospital. We conclude that survival has improved for adolescents and young adults with acute leukaemia but that there is at present no evidence that centralized treatment results in a survival benefit for patients in this age group. (+info)
(3/13843) U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis.
In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration. The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States. The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases. (+info)
(4/13843) Issues in the treatment of active tuberculosis in human immunodeficiency virus-infected patients.
Most HIV-infected patients with tuberculosis can be treated satisfactorily with standard regimens with expectations of good results. Treatment of tuberculosis in these patients has been complicated by the introduction of HAART, which relies on drugs that interfere with the most potent class of antituberculous medications. Rifampin-free regimens or regimens that employ rifabutin may be acceptable strategies for patients who are receiving protease inhibitors, although these regimens have not been rigorously evaluated in patients with AIDS. At present, there is good reason to believe that a 6-month course of a rifabutin-containing regimen or a 9-12-month course of a regimen of streptomycin, isoniazid, and pyrazinamide should be adequate therapy for most patients with drug-susceptible disease. As the treatment of HIV infection with antiretroviral agents evolves, the treatment of tuberculosis in patients with AIDS is likely to evolve as well. This will require careful coordination of antituberculosis and antiretroviral therapies. (+info)
(5/13843) Contralateral fracture of the proximal femur. Implications for planning trials.
In three consecutive years 462 patients over the age of 60 years presented at Waikato Hospital, Hamilton, New Zealand, with a fracture of the proximal femur. Within two years, 11 (2.4%) returned with a fracture of the contralateral femur. If the effectiveness of any form of treatment aiming at reducing the incidence of contralateral fracture were subjected to a trial, a sample size of 5000, randomly distributed equally between treatment and placebo groups, would be needed for the trial to have a power of 80% to detect a reduction. (+info)
(6/13843) Advances in therapy of multiple myeloma: lessons from acute leukemia.
This paper traces the lack of progress, until recently, in the treatment of multiple myeloma (MM) to having ignored the principles that led to cure in acute leukemia more than 2 decades ago. Only in the mid-1980s did investigation begin to consider complete remission (CR) a research objective, representing a necessary first step toward cure. The experience with autologous and allogeneic stem cell-supported high-dose therapy is reviewed, demonstrating, in both historically controlled and randomized studies, the validity of the dose-response concept in MM in terms of increased CR rates as well as extended event-free (EFS) and overall survival (OS). Avoidance of hematopoietic stem cell-damaging agents, especially melphalan, nitrosoureas, and ionizing radiation to marrow-containing sites, assures the ability of peripheral stem cell collection of high quality and quantity, providing rapid engraftment so that mortality is well under 5% following high-dose melphalan (200 mg/m2). This treatment can be applied safely to patients even >70 years of age and in the presence of renal failure. Tandem autotransplants after multiregimen induction have yielded CR rates in the 40% range with median durations of EFS and OS of 43 and 62 months, respectively. Certain chromosomal abnormalities (11 and 13; and translocations) represent the dominant adverse prognosticator for EFS and OS, confirmed in over 500 patients including those with prior therapy. Allogeneic transplants, possible in less than 10% of MM patients, are associated with a 50% mortality during the first year and, unfortunately, late relapses; thus, this approach should be reserved for patients with high-risk disease early in their management. A risk-based treatment algorithm that matches a patient's disease risk with the risk of intervention is presently used, followed by bisphosphonate therapy, not only to delay the onset of MM-related bone disease but also to induce tumor cell apoptosis, indirectly or directly, by down-regulation of cytokines with antiapoptotic activities. Although many patients relapse, this author subscribes to his mentor's motto: "Be Prepared for Success!". (+info)
(7/13843) Drug development in solid tumors: personal perspective of Dr. Emil J Freireich's contributions.
The development of chemotherapy for patients with the major cancers progressed from the initial success attained in the treatment of acute leukemias and choriocarcinoma. Many of the principles of therapy were based on the concepts developed in the experimental laboratories and early clinical studies done at the NIH Clinical Center and other centers around the country. The purpose of this review is to describe some of the early advances in cancer therapy and show how many are based on the efforts of Dr. Emil J Freireich. Over his career, Dr. Freireich has published more than 500 papers and worked on more than 70 different drugs and combinations. The principles defined by Dr. Freireich, namely, the use of intermittent intensive chemotherapy to induce complete remissions (CRs), intensification of therapy in remission, and the use of unmaintained remissions to assess cure, have been important in developing curative chemotherapy programs in patients with acute leukemias. These same principles were applied to combination therapy of Hodgkin's disease as the nitrogen mustard, vincristine, procarbazine, and prednisone combination was developed. This led to the high CR and cure rate for this disease. The treatment of metastatic breast cancer does not produce a high proportion of CRs, and cures of metastatic disease are unlikely with chemotherapy alone. But adjuvant chemotherapy after surgery has resulted in a significant reduction in cancer mortality. Many challenges remain in increasing the cure rate for the major solid tumors. New avenues of controlling cell growth and metastases need to be explored. One approach that is exploitable is the use of drugs or nutrients to prevent cancer. Laboratory approaches are now becoming a clinical reality. (+info)
(8/13843) Can we cure indolent lymphomas?
The current consensus is that indolent lymphomas are incurable disorders. There are some indications that these malignancies are potentially curable. Indeed, not all indolent lymphomas are currently incurable. For example, patients with Ann Arbor stage I-II indolent lymphomas can experience long-term disease-free survival and probable cure. Also, from the available literature data, it seems that the achievement of a molecular complete remission is a desirable objective. Patients who achieve a persistently negative PCR state seldom relapse, whereas the opposite is true for persistently positive cases. In view of its excellent correlation with disease-free survival when examined serially in multiple blood or marrow samples, the PCR technique has the potential of providing a tumor marker that can be used as an early end point for clinical trials. By serving as an early surrogate end point, PCR could play an important role in expediting the development of new treatment strategies. Whether IFN is capable of increasing the molecular complete remission rate as measured by PCR is not known. However, it is clear that from the clinical standpoint, IFN has been able to increase 2-fold the length of remission in patients with advanced indolent lymphomas. In at least two studies, this has been associated with prolongation of survival. More intensive regimens such as alternating triple therapy, when used in combination with IFN, seem to have improved the quality of remissions as judged by the PCR assay. Finally, the site where the bcl-2 breakpoint occurs seems to have clinical significance. Those follicular lymphomas with germ-line bcl-2, in our experience, have behaved more aggressively than the others, and their failure-free survival seems different from the usual indolent lymphomas and more closely resembles the large cell lymphomas. Although the biological significance of this observation is not yet understood, this group might actually constitute a prognostically different subset with a more aggressive and perhaps more curable lymphoma. Whether the plateau observed in their failure-free survival curve will be maintained with more follow-up and whether they might be a curable subset remain to be determined. (+info)
- This study will examine characteristics and behaviors of young women in India and Tanzania to determine which challenges and opportunities exist for conducting future trials of HIV prevention treatments. (clinicaltrials.gov)
- Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. (prnewswire.com)
- The efficacy of psychosocial treatments for PG, including cognitive-behaviour therapy (CBT) and motivational interviewing (MI) approaches, has been supported in a handful of clinical trials. (clinicaltrials.gov)
- Efficacy studies provide substantially less information about the actual utility of treatments than do effectiveness trials because the way in which treatment is actually provided in the field (with flexibility in terms of time-frame and technique and the tendency to address co-occurring problems) is different from the much more single-focused (on gambling) way it is conducted in laboratory settings. (clinicaltrials.gov)
- These interviews and discussions will address differences in HIV risk characteristics between groups of women and the legal, social, cultural, and delivery factors hindering women's participation in microbicide trials. (clinicaltrials.gov)
- Resunab is an interesting treatment in phase II clinical trials for cystic fibrosis, scleroderma, and dermatomyositis. (sclero.org)
- I was not able to get into the Phase II trial, but if it moves to Phase III I plan on asking my scleroderma specialist if I am eligible. (sclero.org)
- Sorrento intends to promptly initiate a multicenter, Phase 1b clinical trial of RTX administered by epidural injection for the treatment of intractable pain associated with cancer. (prnewswire.com)
- RTX has been extensively tested in animals and is currently the subject of a Phase I clinical trial at the National Institute of Health (NIH) under a Cooperative Research and Development Agreement (CRADA). (prnewswire.com)
- This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. (clinicaltrials.gov)
- Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. (omicsonline.org)
- In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. (clinicaltrials.gov)
- Our intention is to commence our clinical path in cancer since more than 80% of cancer patients experience uncontrolled pain during their disease and 20% of these patients remain unresponsive or intolerant to mainstay, opioid therapy i . (prnewswire.com)
- We are confident in RTX providing meaningful relief to these patients given previous pre-clinical and clinical findings demonstrating that a single injection of RTX could safely and effectively reduce severe pain as well as the use of concomitant analgesics," said Dr. Henry Ji , President and Chief Executive Officer of Sorrento Therapeutics, Inc. (prnewswire.com)
- The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). (clinicaltrials.gov)
- The investigators propose to conduct a treatment effectiveness trial examining a combined cognitive motivational behavior therapy (CMBT) delivered by community-based problem gambling treatment providers, compared with treatment as usual (TAU). (clinicaltrials.gov)
- It's usually not helpful to know if someone is in a clinical trial, because they may be receiving the placebo rather than the study drug, and even people on placebos can sometimes improve dramatically. (sclero.org)
- We propose to study resistance in a pediatric HIV-1 clinical trial involving 100 children. (clinicaltrials.gov)
- Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. (clinicaltrials.gov)
- METHODS: Randomized clinical trial including 62 infertile women who had a background of the first IVF treatment cycle cancelled because of poor follicular response. (omicsonline.org)
- The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa. (clinicaltrials.gov)
- Step II will include clinical evaluations, laboratory evaluations, and an adherence assessment for the women and their infants. (clinicaltrials.gov)
- Preliminary results from the NIH trial demonstrate that a single injection of RTX was well tolerated at the dose levels tested and provided clinically meaningful reductions in pain and a reduced dependence on opioids. (prnewswire.com)
- A simple HIV test design and easily interpretable, fast results are logistical advantages in clinical settings such as the labor and delivery unit. (clinicaltrials.gov)
- Therefore, clinical practice often cannot reproduce published results. (clinicaltrials.gov)
- Forward-looking statements include statements regarding the outcome of the data from a clinical trial for RTX, and Scintilla's prospects, Sorrento's M&A strategy and Sorrento's ability to accelerate the development of its lead programs, particularly in oncology, in the clinic. (prnewswire.com)
- Clinical trials for oral cancer look at new ways to treat oral cancer. (ghc.org)
- For more information, see www.cancer.gov/clinicaltrials or http://clinicaltrials.gov. (ghc.org)
- For support in managing these changes, see the topic Getting Support When You Have Cancer . (ghc.org)
- Most major cancer centers post the trials in which they participate on their websites. (nytimes.com)
- The activities are organized according to the priority topics discussed in the Opportunities Report and List , also available on the Critical Path Web page. (fda.gov)
- FDA is collaborating with the Critical Path Institute (C-Path) and the University of Utah on the Cardiovascular Drug Safety and Biomarker Research Program to establish an evidence-based framework for determining the clinical utility of cardiovascular biomarkers, including genetic variants that determine the anticoagulation response to warfarin. (fda.gov)
- Just wondering if anyone is currently on the Resunab clinical trial. (sclero.org)
- Several clinical trials of these products have been conducted, but few have tested populations of young women, who may have different characteristics or behaviors from other women. (clinicaltrials.gov)
- This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level. (clinicaltrials.gov)
- The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. (clinicaltrials.gov)