Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Works about 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.
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.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about 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.
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.
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.
A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.
Works about 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.
Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.
Works about 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.
Elements of limited time intervals, contributing to particular results or situations.
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.
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.
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.
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.
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
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.
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)
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.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
A publication issued at stated, more or less regular, intervals.
Substances that inhibit or prevent the proliferation of NEOPLASMS.
Earlier than planned termination of clinical trials.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
Therapy with two or more separate preparations given for a combined effect.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
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)
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.
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.
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.
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.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
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.
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).
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
The teaching or training of patients concerning their own health needs.
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.
Activities performed to identify concepts and aspects of published information and research reports.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
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.
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.
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.
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.
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.
The relationship between the dose of an administered drug and the response of the organism to the drug.
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.
Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.
The giving of drugs, chemicals, or other substances by mouth.
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.
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.
Financial support of research activities.
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)
Voluntary cooperation of the patient in following a prescribed regimen.
A subspecialty of internal medicine concerned with the study of neoplasms.
Tumors or cancer of the human BREAST.
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.
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 involvement in the decision-making process in matters pertaining to health.
The return of a sign, symptom, or disease after a remission.
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
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.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
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.
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.
"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.
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.
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.
Method of measuring performance against established standards of best practice.
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.
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.
Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.
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.
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.
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.
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)
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)
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
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.
A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.
The 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.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
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.
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.
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 produced by a single clone of cells.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
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.
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.
Tumors or cancer of the LUNG.
Use of plants or herbs to treat diseases or to alleviate pain.
Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.
Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.
Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.
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).
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.
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
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)
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.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
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 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.
Those individuals engaged in research.
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.
Disease having a short and relatively severe course.
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 whose membership is limited to physicians.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
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.
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.
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.
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.
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).
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 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.
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.
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.
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.
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.
An infant during the first month after birth.
The giving of advice and assistance to individuals with educational or personal problems.
Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.
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.
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.
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)
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.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
Works about books, articles or other publications on herbs or plants describing their medicinal value.
The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.
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.
The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.
Substances that reduce the growth or reproduction of BACTERIA.
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.
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)
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.
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.
A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.
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.
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.
A partial or complete return to the normal or proper physiologic activity of an organ or part following disease or trauma.
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.
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)
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.
The use of humans as investigational subjects.
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.
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.
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.
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.
Agents that prevent clotting.
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).
The application of modern theories of learning and conditioning in the treatment of behavior disorders.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
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.
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.
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.
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.
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)
The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER.
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
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)
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.
Education that increases the awareness and favorably influences the attitudes and knowledge relating to the improvement of health on a personal or community basis.
A course of study offered by an educational institution.
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.
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)
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)
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.
Reduction of high-risk choices and adoption of low-risk quantity and frequency alternatives.
Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.
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.
Encouraging consumer behaviors most likely to optimize health potentials (physical and psychosocial) through health information, preventive programs, and access to medical care.
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.
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.
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.
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.
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).
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.
Substances that reduce or suppress INFLAMMATION.
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.
Tumors or cancer of the PROSTATE.
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.
The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra.
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.
Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.
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.
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)
Therapeutic approach tailoring therapy for genetically defined subgroups of patients.
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.
The process of finding chemicals for potential therapeutic use.
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.
Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.
Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system.

Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise. (1/13843)

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)

Patterns of care and survival for adolescents and young adults with acute leukaemia--a population-based study. (2/13843)

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)

U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. (3/13843)

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)

Issues in the treatment of active tuberculosis in human immunodeficiency virus-infected patients. (4/13843)

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)

Contralateral fracture of the proximal femur. Implications for planning trials. (5/13843)

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)

Advances in therapy of multiple myeloma: lessons from acute leukemia. (6/13843)

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)

Drug development in solid tumors: personal perspective of Dr. Emil J Freireich's contributions. (7/13843)

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)

Can we cure indolent lymphomas? (8/13843)

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)

Healthcare Clinical Trial Management Systems - Global Market Demand, Growth, Opportunities, Manufacturers, Analysis of Top Key Players and Forecast to 2025. PUNE, MAHARASHTRA, INDIA, February 13, 2018 /EINPresswire.com/ - Healthcare Clinical Trial Management Systems Market 2018 Description: In this report, the global Healthcare Clinical Trial Management Systems market is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2025, growing at a CAGR of XX% between 2017 and 2025.. Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), market share and growth rate of Healthcare Clinical Trial Management Systems in these regions, from 2013 to 2025 (forecast), covering ...
are research studies that test new ways to prevent detect treat or manage cancer or other diseases Clinical trials provide information about the safety and effectiveness of new approaches to see if they should become widely available Most of the standard cancer treatments used today were first shown to be effective through clinical trials Participation in a clinical trial may be an option for a person with cancer or someone at risk for developing cancer People decide for themselves whether or not they want to participate in a clinical trial The importance of clinical trials Clinical trials add to the progress that is being made against cancer They answer important scientific questions and lead to future research Many people with cancer are now living longer because of progress made through clinical trials Findings from past clinical trials have led to new and more effective drugs for specific types of cancer drugs with fewer side effects less invasive methods of surgery Types and phases There ...
We have been talking a lot recently about NIHs efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials. Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.. The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human ...
Despite the best intentions of the European Medicines Agency injunctions issued against it in two court cases have spilled over to chill other requests for clinical trial information. There are at least 100 pending requests seeking trial results. Over the past 24 hours researchers have received letters telling them the EMA cannot release documents it holds from clinical trials of medicines currently used in Europe.. The letter from the EMA states that in the course of on-going legal proceedings before the General Court of the European Union, the Agency has been ordered to suspend the implementation of certain decisions granting access to documents submitted by marketing authorisation holders of medicinal products.. The legal proceedings are the cases brought by two pharmaceutical companies, InterMune and AbbVie, who challenged the Agencys decisions to grant access to clinical study reports from clinical trials of drugs from each of these companies. On 25th April the President of the European ...
Press Release issued Jul 13, 2015: GlobalDatas clinical trial report, Cholera Global Clinical Trials Review, H1, 2015 provides an overview of Cholera clinical trials scenario. This report provides top line data relating to the clinical trials on Cholera. 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). Global Data Clinical Trial Reports are generated using Global Datas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.
Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Read more. ...
Cancer Research UK scientists have invented a new experimental drug that aims to harness the full power of the bodys own immune system, launching a two-pronged response against cancer, according to a study published in Nature Cancer today. In the study, partly funded by Cancer Research UK, the new immunotherapy drug, which targets suppressive regulatory immune cells inside a tumor, significantly improved long-term survival in animal models even when used without other drugs. If this, and larger follow-up trials, are successful, it could lead to a new immunotherapy treatment for people with high numbers of a certain type of immune cell that are found in cancers including melanoma, some lung cancers and head and neck cancer.The drug is now being developed in early phase clinical trials to determine its safety in people with advanced cancer.
Reporting Clinical Trial Results To Inform Providers, Payers, And Consumers Conventional analyses of clinical trials can underestimate potential risks and benefits to patients. by Rodney A. Hayward, David
Glycotope Receives Regulatory Approval For Glycoexpress(TM) Technology And Initiates First Clinical Trial With Lead Antibody GT-MAB 2.5-GEX - read this article along with other careers information, tips and advice on BioSpace
The Early Phase Clinical Trials Team (EPCTT) was established in 2008 to focus on early phase trials and experimental medicine for priority cancers for the Anglia region.
Clinical trials may offer participating patients options and access to investigational treatments that they would not have otherwise. As scientists search for improved therapies, patients who participate in these trials offer a chance for future patients to benefit from this groundbreaking work. However, patients may hesitate to investigate trial options for various reasons.. There are many myths that surround clinical trials. One of the most common misconceptions is that trials are only for people who have exhausted all other standard treatment options. It is true that clinical trials may be suggested in cases where standard of care treatment options have not been successful, but this is not the only time that they are available. In fact, there are trials available where a drug is added to standard of care chemotherapy to improve the efficacy of the chemotherapy.. What benefits are there to investigating clinical trials as soon as possible? Finding trials that match your needs takes time. There ...
HASBROUCK HEIGHTS, NJ (November 23, 2009) Nymox Pharmaceutical Corporation (NASDAQ NYMX) announced today the release of positive new clinical trial data from re
Copenhagen, Denmark New clinical trial data just published in Pediatric Diabetes show that Levemir (insulin detemir), Novo Nordisk s basal insulin analogue, is
The Experimental Tuberculosis Unit, together with the Pharmacology Dept of the Hospital Universitari Germans Trias i Pujol and the Clinical Trials Unit of the IGTP, present today the results of NYADATREG (ClinicalTrials.gov Identifier: NCT02076139) , the first clinical trial conducted with the food supplement Nyaditum resae®. Designed and patented at the Experimental tuberculosis Unit and…
Since its inception, a major weakness in clinical trial research has been an inability to recruit diverse populations into clinical trials. These under-represented populations are mostly comprised of the poor, the elderly, children, women, and racial/ethnic minorities (African Americans and Hispanics). This fundamental weakness is further exacerbated by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. There are various patient specific, provider specific, and policy related causes for the existence of these disparities. Regardless of the cause, the lack of participation of these groups in clinical trials raises important questions about the quality and ethics of clinical research. The goal of this document is to discuss the evidence and reasons behind disparities in clinical trial participation. We also provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of
is this a new one? Medical College selected as one of 7 sites for first clinical trial to use human embryonic stem cells By Mark Johnson of the Journal Sentinel July 11, 2011 5:26 p.m. |(1) Comments The Medical College of Wisconsin is to be one of seven sites for the first trial to use human embryonic stem cells in the treatment of spinal cord injuries.
In an international clinical trial a new drug that selectively blocks...Patients who took the experimental drug a co-stimulatory blocker call...In the August 25 issue of The New England Journal of Medicine researc...The results mark an important step toward proving the value of a new t... This is the first clinical trial of a treatment for transplant recipi...,New,type,of,rejection,blocker,protects,kidneys,after,transplant,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
In an article reporting the 18-month results of the ITNs RAVE clinical trial, published August 1st in the New England Journal of Medicine, the ITN is providing unfettered access to the underlying clinical data and analysis code via the new clinical trials research portal, ITN TrialShare. TrialShare is a significant advance in data sharing and transparency, allowing for collaborative hypothesis generation and specimen sharing between the ITN and the broader scientific community. TrialShare gives researchers the ability to access raw study data, confirm published conclusions and interactively perform their own exploratory analyses using this data.. Direct access to raw clinical trial data will change the landscape of collaborative research said Peter C. Grayson, MD, MSc of Boston University Medical Center, a collaborator with the ITN. TrialShare creates unfettered opportunities to explore and understand the intricacies of clinical trial data. Better understanding of primary data leads to ...
Penn Medicine will conduct the Northeasts first clinical trial of uterine transplants, to provide women with Uterine Factor Infertility (UFI) -- an irreversible form of female infertility that affects as many as 5 percent of women worldwide and 50,000 women in the United States -- with a new path to parenthood.
PathMaker Neurosystems and Feinstein Institute Announce Initiation of First Clinical Trial of MyoRegulator to Treat Muscle Contraction
Clinical Courses - This is designed to give you an overview of the clinical Drug Trials trainings from many other topics as they apply to your position in the organization.
BEIJING, March 10, 2011 /PRNewswire-Asia/ -- Sinovac Reports Positive Preliminary Phase I Clinical Trial Results for EV71 Vaccine in Adult Group. Unblinded...
Welcome to the eCancerTrials.com National Cancer Clinical Trials Database. When you or a loved one are diagnosed with cancer, knowing every treatment option available is your first step in receiving the most complete care. Your treatment plan may include choosing to participate in a cancer clinical trial. Clinical trials in cancer are research studies designed to evaluate new cancer treatment, management, and prevention options. Clinical trials conducted with cancer patients evaluate the safety and effectiveness of new or modified cancer treatment strategies. New anticancer drugs, unique approaches to surgery and radiation therapy are used as well as various combinations of cancer treatments.. Many medical professionals encourage those diagnosed with cancer to at least consider participating in a clinical trial in addition to other treatment options. Furthermore, many treatment options for cancer patients are only available through clinical trials, making participation in a trial the only way to ...
HPV is a major cause of changes in the cervix. These changes are much more common in women with HIV and could lead to cancer of the cervix. The AIDS ...
Three-Year Clinical Trial Results Support ILUVIEN® Launch in Europe for the Prevention of Relapse in Recurrent Non-Infectious Uveitis Affecting the Posterior Segment - - Alpharetta (Georgia)
I just finished my public comments to the EU about the Summary of Clinical Trial Results for Laypersons. You can too if you hurry (public comments end on 8/31/16). Here are the instructions. I would appreciate your support on some of the key points listed below. A bit of background The European Medical Agency (EMA)…
Lipocine Announces LPCN 1144 Clinical Trial Results Selected for Late-Breaker Presentation at The Liver Meeting® 2018 - read this article along with other careers information, tips and advice on BioSpace
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
Participating in an observational study or a controlled clinical trial may involve a time commitment and some risks. However, doing so may provide health benefit…
Modernization of eligibility criteria could have beneficial effects on improving clinical trial enrollment, said speakers representing the first panel at the FOCR meeting. Its been a struggle to put patients on trials, said Edward S. Kim, MD, a co-author of the first white paper, Chair of Solid Tumor Oncology and Investigational Therapeutics and holder of the Donald S. Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute, Carolinas HealthCare System in Charlotte, N.C.. Authors of the first white paper concluded there is a need for a re-evaluation of clinical trial eligibility, including the exclusion of patients with prior cancers. They noted that data have shown prior malignancies did not impact survival outcomes in patients with stage IV lung cancer or locally advanced lung cancer, suggesting clinical trial outcomes would not be adversely impacted by inclusion of patients with a history of prior cancer. The first panel concluded patients should not be routinely ...
Research has shown again and again that the best way to improve treatment is through the clinical trial process. This process sets up a rigorous set of scientific questions and the criteria needed to answer them.. Clinical trials require resources, in the form of funding to run them, and patients to enroll in them. Without patients willing to enroll on trials for new treatments, it isnt possible to determine whether new treatments are indeed better than the current standard treatment. And yet, less than 10 percent of adults with cancer enroll on clinical trials. In contrast, up to 90 percent of children with cancer are routinely enrolled on clinical trials. This high participation rate undoubtedly has contributed to the substantial increase in childhood cancer survival rates over the last generation.. The low participation in adult clinical trials is so worrisome to cancer researchers that the National Cancer Institute (NCI) and the American Society of Clinical Oncologists (ASCO) held a ...
Researchers face multiple obstacles that can hinder their ability to show whether a potential lupus treatment works or may be better than a current treatment. Years of disappointing results in lupus drug development demonstrates that a different approach is needed.. In 2009, the Lupus Foundation of America established the LFA Collective Data Analysis Initiative (LFA CDAI), a first-in-lupus collaboration among multiple companies with a shared goal - to improve clinical trials so we can have an arsenal of treatments needed for people living with lupus.. Since its inception, LFA CDAI has published important findings on the impact of background medications taken by people with lupus during clinical trials. The latest LFA CDAI analysis builds upon this work.. In this study, researchers looked at the long-term effects of a potential treatment on health outcomes. The results showed that shorter Phase 2 clinical trials may not be effective at predicting outcomes in longer clinical trials.. Researchers ...
New Clinical Trials in Prostate Cancer. William K. Oh, M.D. Clinical Director, Lank Center for Genitourinary Oncology Dana-Farber Cancer Institute Associate Professor, Harvard Medical School. U.S. Cancer Statistics: Prostate Cancer 2007. Leading cause of cancer in men (218,890 cases, 29%) Slideshow 63801 by RexAlvis
This resource center is for patients and families coping with cancer and interested in learning about clinical trials for the disease. You can find information here on how clinical trials are structured and managed, how to find and evaluate clinical trials, how eligibility to participate is determined, the ethics of conducting clinical trials, special types of clinical trials, and financial issues related to clinical trials.
Selection of target sample size is a critical factor in the design of any randomized trial. Although calculations are straightforward, the underlying assumptions are frequently based on incomplete data. Relatively small errors in the assumptions can design a trial that is either substantially under- or overpowered.. One of the more rapidly evolving clinical trial methodological areas is that of adaptive clinical trials, where the study design is adjusted based on data collected as part of the initial conduct of the trial. Methods for adaptive trials are sometimes confused with the much more mature methodological area of group sequential trials.7-9 Shih eloquently relates that group sequential trial methodology has the goal of saving lives or saving resources whereas the adaptive clinical trial approach has the goal of saving the study.10. There are 2 approaches of adaptive trial methodology. The first examines estimates of parameters that were assumed during the design phase of the project ...
Browse Global Clinical Trial Management Systems (CTMS) Market report of 115 pages, 20 Table of Contents, 10 Companies and available at https://www.research
A clinical trial is a research study on human volunteers designed to answer specific health questions. The purpose of a clinical trial is to find out whether a medicine or treatment regimen is safe and effective against a specific condition or disease.. Clinical trials compare the effectiveness of the study medicine or treatment against standard, accepted treatment or a placebo. (A placebo is an inactive substance used to compare results with an active substance). Early (phase I) trials establish the safety, toxicity, and safe dosing ranges of a new treatment.. A clinical trial may be sponsored by a government agency, such as the National Institutes of Health, or a pharmaceutical or biotechnology company. All clinical trials are guided by government regulations. These rules make sure that participants are not likely to be harmed and that they fully understand the risks and benefits of participating. ...
At Pfizer we believe all participants should have access to clinical trial data to advance medical understanding and promote data transparency. Pfizer believes that it is important for researchers, trial participants, regulators, and others acting in the best interest of patients to have access to clinical trial information to advance medical understanding and progress. Its also important that this access works in ways that protect patient privacy, preserve regulatory authority and maintain incentives for those who generate data to conduct new research.
RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.
Clinical trials are the engine room that powers our ability to deliver new treatment options to patients. The rigorous testing and resulting data that help us understand how new treatments work are what propels our industry forward.. But the engine room has flipped a switch. Governments have brought in various measures to reduce the number of COVID-19 infections and to help health systems cope with related pressures. The impact of these measures, compounded by pressures on supply chains, coupled with new recommendations from regulators on managing clinical trials, as well as companies own internal reprioritisations, have created a perfect storm in R&D. Hundreds of trials have been affected-including delays and disruptions to ongoing trials and cancellations or revisions to planned ones-and more changes are expected.. Furthermore, many healthcare providers have been pulled in to support critical care needs or at-risk patients, leaving less time and resources for clinical trials. This leaves ...
Read about Qu Biologics Cleared to Proceed with Crohns Disease Clinical Trial, according to a review from the Data Safety Monitoring Committee.
All patients complete a baseline assessment to assess demographics, personal characteristics, preparedness, and barriers to clinical trials. All patients also undergo a post-intervention assessment and complete a survey to measure preparedness for consideration of clinical trials, and impact of the intervention on clinical trials barriers. A brief patient post-consultation assessment is completed by patients within two weeks of the physician consultation to determine whether clinical trials were discussed, patient satisfaction with discussion about clinical trials, treatment options, treatment selection, decisional conflict, and satisfaction with treatment decision. Quality of informed consent is also assessed for patients participating in a clinical trial and completing the consent process during their initial physician consultation. Each patients physician completes a brief Physician Post-Consultation Assessment to define cancer stage, treatment goal, and to determine whether clinical trials ...
We have an exciting opportunity for a Portfolio Lead to join the Oncology Clinical Trials Office (OCTO), working in a team of trial management professionals running a varied portfolio of clinical trials and related sub-studies.You will be responsible for working with Chief Investigators and statisticians to develop new research proposals for funding applications, developing new clinical trial protocols, coordinating application submissions and ensuring that all appropriate documentation, reviews and approvals are in place.You will be responsible for the line management and oversight of proj ...
Taking part in a clinical trial can be a good choice but it is often hard to find a clinical trial that is right for you. Many patient organisations and websites maintain lists of clinical trials. The following table lists some of the clinical trials available worldwide. Please note: this is not an exhaustive list, so please check with your local patient organisation. Other trials may be available in your country. If you are aware of an open trial that should be listed here, please send us the trial information to: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.. ...
The Oncology Clinical Trials Program enables patients to access a wide spectrum of newly advanced treatments including immunotherapeutic drugs and targeted therapies for a range of solid and haematological malignancies.. Established in 2003 and led by Associate Professor Gary Richardson OAM, the Department aims to provide compassionate, state-of-the-art care for cancer patients and continued advancements in the prevention, diagnosis, treatment and cure of cancer via a combination of research, education and clinical practice.. How can you participiate in a clinical trial at Cabrini. The Szalmuk Family Department of Medical Oncology currently has more than 100 active clinical trials covering many different cancer streams. If you are interested in participating in a trial, please speak to your treating oncologist first. Your oncologist will provide you with general information on clinical trials and also discuss programs that may be relevant to you.. All patients with private health insurance can ...
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
Ask your neurologist or movement disorders specialist about participation in clinical trials. Specifical clinical trials vary by region and center. If you are receiving treatment at a specialized movement disorders center, there may be already ongoing trials at your center in which you can participate. The website www.clinicaltrials.gov also has updated information in all current clinical trials performed in the United States.
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record. ...
Given a potentially huge set of candidate criteria, our goal is to help users choose the most appropriate criteria from among the candidates. In this work, we assume that the candidate criteria exist in some document(s) in a given repository, either separately from different documents or together in the same document, and our technical objective is to rank these candidates according to their appropriateness to the task at hand. As mentioned previously, such task would be to put together a clinical trial protocol about some particular disease, treatment, or drug.. To provide a concrete idea of our problem, the following is a snippet of a clinical trial protocol, downloaded from the clinical trials website http://www.clinicaltrials.gov, and modified for presentation as an example. It shows the title, the objective of the clinical trial as well as the inclusion and exclusion criteria.. Title: Antioxidant Systems and Age-Related Macular Degeneration Objective:. The objective of this study is to ...
O:13:\PanistOpenUrl\:36:{s:10:\\u0000*\u0000openUrl\;N;s:6:\\u0000*\u0000idc\;N;s:6:\\u0000*\u0000fmt\;s:7:\journal\;s:6:\\u0000*\u0000doi\;s:0:\\;s:6:\\u0000*\u0000pii\;s:0:\\;s:7:\\u0000*\u0000pmid\;s:0:\\;s:9:\\u0000*\u0000atitle\;s:134:\A DOUBLE-BLIND CROSS-OVER TRIAL OF INDOMETHACIN, FENOPROFEN AND PLACEBO IN ANKYLOSING SPONDYLITIS, WITH COMMENTS ON PATIENT ASSESSMENT\;s:9:\\u0000*\u0000jtitle\;s:0:\\;s:9:\\u0000*\u0000stitle\;s:0:\\;s:7:\\u0000*\u0000date\;s:4:\1980\;s:9:\\u0000*\u0000volume\;s:0:\\;s:8:\\u0000*\u0000issue\;s:0:\\;s:8:\\u0000*\u0000spage\;s:0:\\;s:8:\\u0000*\u0000epage\;s:0:\\;s:8:\\u0000*\u0000pages\;s:0:\\;s:7:\\u0000*\u0000issn\;s:0:\\;s:8:\\u0000*\u0000eissn\;s:0:\\;s:9:\\u0000*\u0000aulast\;s:7:\SHIPLEY\;s:10:\\u0000*\u0000aufirst\;s:1:\M\;s:9:\\u0000*\u0000auinit\;N;s:10:\\u0000*\u0000auinitm\;N;s:5:\\u0000*\u0000au\;a:3:{i:0;s:9:\SHIPLEY M\;i:1;s:7:\BERRY H\;i:2;s:7:\BLOOM ...
Defining a sound strategy for patient recruitment is the primary theme of this, the tenth book in an evolving series of pragmatic texts written for the clinical trials professional. Because patient recruitment problems are the most important reason for the failure of clinical trials, a strong need exists for a source that gathers numerous ideas for patient recruitment. The authors provide examples of letters, brochures, announcements, and campaigns that can be sculpted to reach intended study populations. Another strength is the checklist-oriented tables and study-specific figures that are based on current clinical trials ...
GlobalDatas clinical trial report, Atopic Dermatitis Global Clinical Trials Review, H1, 2017 provides an overview of Atopic Dermatitis clinical trials scenario. This report provides top line data relating to the clinical trials on Atopic Dermatitis. 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). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.. The report enhances the decision making capabilities and helps to create ...
Summary. GlobalDatas clinical trial report, Vitiligo Global Clinical Trials Review, H1, 2015″ provides an overview of Vitiligo clinical trials scenario. This report provides top line data relating to the clinical trials on Vitiligo. 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). Global Data Clinical Trial Reports are generated using Global Data s proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.. View Full Report with TOC at ...
Summary. GlobalDatas clinical trial report, Vitiligo Global Clinical Trials Review, H1, 2015″ provides an overview of Vitiligo clinical trials scenario. This report provides top line data relating to the clinical trials on Vitiligo. 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). Global Data Clinical Trial Reports are generated using Global Data s proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.. View Full Report with TOC at ...
GlobalDatas clinical trial report, Bronchiectasis Global Clinical Trials Review, H2, 2016 provides an overview of Bronchiectasis clinical trials scenario. This report provides top line data relating to the clinical trials on Bronchiectasis. 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). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.. The report enhances the decision making capabilities and helps to create an ...
GlobalDatas clinical trial report, Blepharospasm Global Clinical Trials Review, H2, 2018 provides an overview of Blepharospasm clinical trials scenario. This report provides top line data relating to the clinical trials on Blepharospasm. 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). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. The report enhances the decision making capabilities and helps to create an effective ...
Results: 210 respondents, including adults and young people with eczema plus carers of children with eczema, which included family and friends. 68% (n=126/185) reported a wide range of 38 unwanted effects. Accounts highlighted the impact on quality of life of these unwanted effects and variations to eczema management that followed. 71% (90/126) of respondents stopped a leave-on emollient due to unwanted effects. Desired characteristics in emollients related to the absence of unwanted effects and product improvements ...
To advance knowledge, identify the most effective care and help future patients, the Edwards Comprehensive Cancer Center maintains an active clinical trials program and maintains a listing of the clinical trials that are currently available.. If you have questions about whether a clinical trial is an option for you, please contact Barbara Payne, RN, OCN, CCRP, Clinical Research Supervisor. For more information about Pediatric Clinical Trials, please contact Teresa Giles at 304.399.6653.. ...
Trial registries serve as a readily accessible online resource for identifying unpublished trials and unreported outcomes. Since 2005, prospective trial registration has gained broad acceptance as an important means of enhancing transparency and tracking the existence of clinical trials at inception. Key stakeholders-including medical journal editors, legislators, and funding agencies-provide enforcement mechanisms that have greatly improved adherence to registration practices.. Basic protocol information on ongoing and completed trials of any intervention type can be retrieved via the World Health Organizations International Clinical Trials Registry Platform Search Portal (www.who.int/trialsearch/). This searches records from national and international trial registries that meet certain standards, including WHO Primary Registries and ClinicalTrials.gov. Users can search the main registry fields using key words related to the study topic, sponsor, recruitment status, and sites. When the same ...
Phenylketonuria (PKU) Global Clinical Trials Review, H1, 2016 provides an overview of Phenylketonuria (PKU) clinical trials scenario. This report provides top line data relating to the clinical trials on Phenylketonuria (PKU). 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). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.. The report enhances the decision making capabilities and helps to create an effective counter ...
The University of Rochester Medical Center is actively engaged in clinical research with potential to improve the health of people and the communities within which they reside. The Clinical Trial Enrollment Unit of the Clinical Cardiovascular Research Center provides resources necessary to support efficient and effective study enrollment using strategic planning and bioinformatics-based tools. The unit works closely with the University of Rochester Clinical and Translational Sciences Center (UR CTSI) to leverage data driven cohort-discovery, collaborator-investigator identification and subject recruitment and retention. Our team includes health subjects coordinators and research finance specialists with diverse experience in clinical care and research involving all aspects of cardiovascular care. Our expertise includes:. ...
A new breast cancer clinical trial is testing the idea a major reason why breast cancer returns after treatment and spreads to other parts of the body is because current chemotherapy and radiation treatments do not kill the cancer stem cells. The trial involves combining standard chemotherapy with a drug that has been found in laboratory studies to attack cancer stem cells.
CHADDS FORD, PA. and BELLEVILLE, ON, Feb. 17- UROCIDIN™ PHASE III CLINICAL TRIAL RESULTS TO BE PRESENTED AT EAU AND AUA CONFERENCES.
Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. In order to optimize both, you have to have a plan and it should take into account all stakeholders from senior management at the sponsor company and the CRO partners, to the sites and investigators and study volunteers. Cambridge Healthtech Institutes Tenth Annual Enrollment Planning and Patient Recruitment conference will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.. ,p justify;\=,. ...
List of Tables. Strabismus Therapeutics, Global, Clinical Trials by Region, 2015* 7. Strabismus Therapeutics, Global, Clinical Trials and Average Enrollment by Top Countries, 2015* 8. Strabismus Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2015* 9. Strabismus Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries, 2015* 10. Strabismus Therapeutics Clinical Trials, Europe, Top Five Countries, 2015* 11. Strabismus Therapeutics Clinical Trials, North America, Top Countries, 2015* 12. Strabismus Therapeutics Clinical Trials, Middle East and Africa, Top Countries, 2015* 13. Strabismus Therapeutics Clinical Trials, Central and South America, Top Countries, 2015* 14. Proportion of Strabismus to Ophthalmology Clinical Trials, G7 Countries (%), 2015* 15. Strabismus Therapeutics, G7 Countries, Clinical Trials by Phase, 2015* 16. Strabismus Therapeutics, G7 Countries, Clinical Trials by Trial Status, 2015* 17. Proportion of Strabismus to Ophthalmology Clinical Trials, E7 ...
When clinical trial results just say no / Biotech companies often are able to bounce back from seeming disaster, thanks to deep reserves and partnerships Love was convinced that his San Carlos biotech companys experimental drug alfimeprase would prove effective against dangerous blood clots. Telik Inc. of Palo Alto, Renovis Inc. of South San Francisco, Berkeleys Dynavax Technologies Corp. and Threshold Pharmaceuticals in Redwood City -- have watched a once-promising lead experimental drug fall flat in the final stages of clinical trials. [...] biotech companies often manage to reinvent themselves, even after the bleakest news. Because major setbacks are so common in medical technology, experienced executives and financiers have developed ways to get companies back on track. All kinds of problems can arise, including shareholder lawsuits, departures of key staff, the loss of development partners and a much tougher climate for financing. [...] companies often have other assets they can draw on
Moderna has just announced that its RNA based vaccine is starting a phase 3 clinical trial with 30,000 subjects, so I thought it might be useful to take a look at the publicly available information about the trial, and how they got there. Lets go logically and chronologically and start with the phase 1 safety study. The Phase 1 study A phase 1 study is a safety study. They usually have relatively few subjects, and different doses are given because dosing in terms of side effects is usually an important endpoint in a safety study. Here is the Brief Summary of the Phase 1 study published by Moderna Brief Summary: This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based
Science magazine reviews the disappointing results of two recent HIV vaccine clinical trials, which sugges[t] that a successful vaccine, the most ...
In this edition of the Huntingtons Disease Clinical Trials Corner we expand on the UniQure AMT-130 and on the Neurocrine Biosciences KINECT-HD trials, and list all currently registered and ongoing clinical trials in Huntingtons disease.
In the early phases of clinical trials, when the number of patients and tests are small, in-house or home-grown program are typically used to handle their data. In later phases, data volumes and complexity grow, motivating many organizations to adopt more comprehensive software. Available software includes budgeting, patient management, compliance with government regulations, project management, financials, patient management and recruitment, investigator management, regulatory compliance and compatibility with other systems such as electronic data capture and adverse event reporting systems. In addition to pharmaceutical and biotechnology industries, CTMSs are widely used at sites where clinical research is conducted such as research hospitals, physician practices, academic medical centers and cancer centers. While pharmaceutical companies that sponsor clinical trials may provide a CTMS to the sites that participate in their trials, sites may operate a CTMS to support day-to-day operations in ...
Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia ...
The three-year clinical trial results of the retinal implant popularly known as the bionic eye, have proven the long-term efficacy, safety and reliability of the device that restores vision in those blinded by a rare, degenerative eye disease. The findings show that the Argus II significantly improves visual function and quality of life for people blinded by retinitis pigmentosa.
SMi Group will once again open its doors to the 11th annual Paediatric Clinical Trials conference taking place on the 20-21 March 2017 in London, UK.
Rare Cancer News & Clinical Trials » Trial - Brain Tumor » Neurophysiological Evaluation of Training Effect on Cancer-Related ...
Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions U.S. Department of Health and Human Services Food and Drug Administration Center for
The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this
GlobalDatas clinical trial report, Candidiasis Global Clinical Trials Review, H1, 2012 provides data on the Candidiasis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Candidiasis. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Candidiasis. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalDatas team of industry experts.
42-25 NCI Surgery Branch Resumes Enrollment In Suspended Immunotherapy Trials - In Brief NCI Surgery Branch Resumes Enrollment In Suspended Immunotherapy Trials    THE NCI SURGERY BRANCH resumed enrollment of patients in clinical protocols evaluating immunotherapy as a treatment for patients with metastatic cancer.
The Pediatric Trials Network (PTN) has received an award to contribute to the National Institutes of Healths (NIH) INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) project. The INCLUDE directive calls for a trans-NIH research initiative to address critical health and quality-of-life needs for individuals with Down syndrome across the lifespan.. One of the three primary components of the INCLUDE initiative is to support clinical trials on conditions and diseases that affect people with Down syndrome, both to accelerate the development of new therapies for individuals with Down syndrome and to include them in ongoing clinical trials.. PTN will work to characterize the pharmacokinetics (PK)A, pharmacodynamics (PD)B and pharmacogenomics (PGx)C of understudied off-patent drugsD administered to children and young adults with Down syndrome. By studying individuals who are receiving these drugs as part of routine care provided by their physicians, ...
The Clinical Study Results Database was created by the pharmaceutical trade group PhRMA as part of an industry-wide effort to expand access to clinical trial data. Moving forward, Pfizer will continue to post data from the companys late-stage clinical studies for marketed medicines ...
Before Its News). Ascites Global Clinical Trials Review, H1, 2016″ provides an overview of Ascites clinical trials scenario. This report provides top line data relating to the clinical trials on Ascites. 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). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database - Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process. For more information http://www.reportsweb.com/ascites-global-clinical-trials-review-h1-2016. Scope. - The report ...
Applied Statistics in Biomedicine and Clinical Trials Design : This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in
AmerisourceBergens IntrinsiQ Specialty Solutions and ION Solutions have launched a clinical trial recruitment network, bringing healthcare providers and biopharma companies together.
TY - JOUR. T1 - A systematic review of adverse event reporting in companion animal clinical trials evaluating cancer treatment. AU - Giuffrida, Michelle. PY - 2016/11/1. Y1 - 2016/11/1. N2 - OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized. Data for AE reporting were collected with a 14-item checklist adapted from the 2004 CONSORT extension for reporting harms. Study characteristics associated with the AE reporting checklist score were identified by means of linear regression analysis. RESULTS 168 articles with ...
Our New Medical Therapies(TM) Trial Results database provides a snapshot of results from completed and ongoing clinical trials, based on published materials from medical conferences, journals and CenterWatch reports. View COPD (Chronic Obstructive Pulmonary Disease) clinical trial results here.
Our New Medical Therapies(TM) Trial Results database provides a snapshot of results from completed and ongoing clinical trials, based on published materials from medical conferences, journals and CenterWatch reports. View Carotid Artery Disease clinical trial results here.
Free Online Library: Ruthigen Announces First Patient Enrollment in the Phase 1/2 Human Clinical Trial of RUT58-60, a Broad-Spectrum Anti-Infective Drug Candidate Designed for Prophylactic Use During Invasive Surgery. by PR Newswire; Business News, opinion and commentary Antibiotics Product development Clinical trials
All patients were provided with a patient information sheet and provided written informed consent and were free to withdraw from the trial at any point without giving a reason. Patient confidentiality was respected according to national regulations and data was coded before computer entry to maintain confidentiality. Blood samples were coded before being sent to Addenbrookes Hospital. Study follow up and blood tests were arranged to coincide with standard hospital appointments to avoid additional hospital visits and blood tests as much as possible. According to the trial protocol, patients who did not respond to their assigned treatment regimen, could be withdrawn from trial protocol and treated with additional therapies as required ...
The report on Dental Pain Global Clinical Trials Review, H1, 2015 provides an overview of Dental Pain clinical trials scenario. This report provides top line data relating to the clinical trials on Dental Pain. 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 ...
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Novoclinica, Inc. is a clinical research organization driven by vision For Better Medicine™. We provide solutions for phase I-IV clinical trials in Russia by improving enrollment into clinical trials and maintaining high level of patient retention. The company operates in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials (GCP).
Reportstack has announced a new market research publication on Bacteremia Global Clinical Trials Review, H2, 2013 which provides elemental information and data relating to the clinical trials on Bacteremia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Bacteremia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by team of industry experts ...
... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ... Gorski, DH; Novella, SP (September 2014). "Clinical trials of integrative medicine: testing whether magic works?". Trends in ... Hróbjartsson A, Gøtzsche PC (May 2001). "Is the placebo powerless? An analysis of clinical trials comparing placebo with no ...
"Clinical Microbiology Reviews (Review). 22 (4): 552-63. doi:10.1128/CMR.00027-09. PMC 2772359. PMID 19822888.. ... Current Topics in Microbiology and Immunology. Ebolavirus and other filoviruses. 315. pp. 363-87. doi:10.1007/978-3-540-70962-6 ... Several trials were conducted in late 2014, and early 2015, but some were abandoned due to lack of efficacy or lack of people ... Kuhn, Jens H. (2008). Filoviruses: A Compendium of 40 Years of Epidemiological, Clinical, and Laboratory Studies. Archives of ...
Clinical observations[edit]. A study involving 2408 donors (18-60 years) indicated that bone pain (primarily back and hips) as ... "The Only Real Cure Out There, for Now " Archived 30 May 2008 at the Wayback Machine.. CLL Topics, Inc. ... "Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National ... 2008). "Clinical applications of blood-derived and marrow-derived stem cells for nonmalignant diseases". JAMA. 299 (8): 925-36 ...
Clinical laboratory sciences are the clinical diagnostic services that apply laboratory techniques to diagnosis and management ... Trial of the Nuremberg trials, Tuskegee syphilis experiment, and others.. Values such as these do not give answers as to how to ... Subspecialties include transfusion medicine, cellular pathology, clinical chemistry, hematology, clinical microbiology and ... Some related clinical specialties include neurology, neurosurgery and psychiatry.. *Nutrition science (theoretical focus) and ...
Grissom RJ (1994). "Statistical analysis of ordinal categorical status after therapies". Journal of Consulting and Clinical ... However it would be rare to find so extended a report in a document whose major topic was not statistical inference. ...
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... List of topics characterized as pseudoscience. *Chiropractic education. *Chiropractic schools. *Councils on Chiropractic ... Ernst E (2009). "Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials". Int J ... Ernst E, Posadzki P (2012). "Reporting of adverse effects in randomised clinical trials of chiropractic manipulations: a ...
42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H-Medical ... Fox-Rawlings S,. Gottschalk L.B., Doamekpor L., Zuckerman D.M. (2018) Diversity in Medical Device Clinical Trials: Do We Know ... Journal of Clinical Engineering[79]. University Based Research Packaging InstitutesEdit. *University of Minnesota - Medical ...
... a randomized placebo-controlled 25-week outpatient trial". Pharmacopsychiatry. 30 (1): 1-5. doi:10.1055/s-2007-979474. PMID ... Journal of Clinical Psychopharmacology. 20 (1): 84-9. doi:10.1097/00004714-200002000-00014. PMID 10653213.. ...
"American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of ... Further randomized controlled trials are needed to delineate these differences more clearly." The conclusions were contrary to ... FFC). Holtorf has published a number of endocrine reviews on complex topics in peer-reviewed journals on controversial diseases ... Clinical Practice Guidelines by the Infectious Diseases Society of America". Clinical Infectious Diseases. 43 (9): 1089-134. ...
"Circular authorizing Peking University to offer the international Fa Lv Shuo Shi on a trial basis" (PDF). Academic Degree ... implementing elements such as clinical training, which has become an essential part of legal education in the U.S. and in the J ... took on a more central role in the preparation of lawyers and consequently improved their coverage of advanced legal topics to ...
... a systematic review of randomized clinical trials". Br. J. Anaesth. 84 (3): 367-371. doi:10.1093/oxfordjournals.bja.a013442. ... A systematic review of clinical trials". Pain Medicine. 12 (12): 1808-18. doi:10.1111/j.1526-4637.2011.01261.x. PMID 22054010. ...
These include psychiatrists, psychiatry physician assistants, clinical psychologists, occupational therapists, clinical social ... https://www.cdc.gov/tb/topic/infectioncontrol/pdf/healthCareSettings-assessment.pdf *^ https://www.cdc.gov/tb/topic/basics/ ... and active training reduce the risk of contamination but that more randomized controlled trials are needed for how best to ... These include physiatrists, physician assistants, rehabilitation nurses, clinical nurse specialists, nurse practitioners, ...
"ISIS initiates Phase 3 clinical trials for potential SMA therapy ISIS-SMNrx". The SMA Trust.. ... Topics. *Contributing property. *Keeper of the Register. *Historic district. *History of the National Register of Historic ... develop a new clinical cancer research unit at Northwell Health in Lake Success, NY, to support early-phase clinical studies of ... In 2014, Phase 3 trials begin for drug to treat spinal muscular atrophy (SMA), a neurodegenerative disease, based on Adrian ...
2004). "Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials". Arch. ... http://www.nia.nih.gov/alzheimers/topics/symptoms. pristupljeno 28 December 2011. ... 4,0 4,1 4,2 4,3 4,4 Förstl H, Kurz A. Clinical Features of Alzheimer's Disease. European Archives of Psychiatry and Clinical ... 2,0 2,1 2,2 2,3 2,4 2,5 2,6 2,7 2,8 Burns, A; Iliffe, S (5 February 2009). "Alzheimer's disease.". BMJ (Clinical research ed.) ...
Chen, R; Hallett, M (1998). "Focal dystonia and repetitive motion disorders". Clinical Orthopaedics and Related Research (351 ... "Decoding auditory attention to instruments in polyphonic music using single-trial EEG classification". Journal of Neural ... Topics. *Absolute pitch. *Auditory illusion. *Auditory imagery. *Background music. *Consonance and dissonance ... Electroencephalography and Clinical Neurophysiology. 54 (6): 642-53. doi:10.1016/0013-4694(82)90118-3. PMID 6183097.. ...
Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. Free ... Basic work teams within the polyclinics supervise and evaluate the neighborhood and clinical health work of the family medicine ... role combine the importance of focusing on both public health and clinical medicine.[38] ...
Parkes, B. Ginsberg, R. Jamal, A. Frid, Ultra-short (5mm) insulin needles: trial results and clinical recommendations. ... Strauss speaks frequently to audiences throughout Europe, Africa and the Middle East on topics related to diabetes, HIV disease ... Clinical Immunology and Immunopathology, 1994; 70:152-158. K. Strauss, I. Hannet, S. Engels, A. Shiba, D. Ward, S. Ullery, M. ... Clinical Immunology and Immunopathology, 1997:122-128. F. Hulstaert, I. Hannet, V. Deneys, V. Munhyeshuli, T. Reichert, M. ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... It is hoped that further understanding of the molecular basis of immunity will translate to improved clinical practice in the ...
... clinical endpoint - clinical latency - clinical practice guidelines - clinical trial - clinicaltrials.gov - cloning - CMS - CMV ... This is a list of AIDS-related topics, many of which were originally taken from the public domain U.S. Department of Health ... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ... Community Programs for Clinical Research on AIDS (CPCRA) - community-based clinical trial (CBCT) - community-based organization ...
... none of these strategies have proven to be efficacious in TBI clinical trials [13-15]. The failure of clinical therapy trials ... Scholia has a topic profile for Biomarker.. Retrieved from "https://en.wikipedia.org/w/index.php?title=Biomarker&oldid= ... Status and relevance for clinical trials". Mov. Disord. (Review). 33 (4): 528-36. doi:10.1002/mds.27355. PMID 29624752.. ... "British Journal of Clinical Pharmacology. 59 (5): 491-494. doi:10.1111/j.1365-2125.2005.02435.x. PMC 1884846. PMID 15842546.. ...
Foster suggests that women would have encountered suspicion about their own lives had they used same-sex love as a topic, and ... Two months later, they were found guilty in a jury trial. The producers were fined $200 and the cast received suspended ... Journal of Consulting and Clinical Psychology, 71 (1), pp. 53-61. ... Between 1955 and 1969 over 2,000 books were published using lesbianism as a topic, and they were sold in corner drugstores, ...
A systematic review of randomised clinical trials". BMJ Open. 4 (11): e006140. doi:10.1136/bmjopen-2014-006140. PMC 4225238. ... Bee venom is under laboratory and clinical research for its potential properties and uses in reducing risks for adverse events ... there are no approved clinical uses for these products which carry various warnings for potential allergic reactions.[82] ... Topics. *Evolution of eusociality. *Presociality. *Social insects *Gamergate. *Group selection. *Haplodiploidy. *Identity in ...
"Public Domain on Trial in Reiss-Engelhorn Museum vs. Wikimedia et al. - International Communia Association". Communia- ... A Bachelor of Medicine (lääketieteen kandidaatti, medicine kandidat) is allowed to conduct clinical work under the supervision ... Wikipedia articles that may have off-topic sections from January 2019. *Articles that may contain original research from July ... All articles that may have off-topic sections. * ...
Related to Bernoulli trials (yes/no events, with a given probability)[edit]. *Basic distributions: *Bernoulli distribution, for ... List of statistical topics. *Kirkwood approximation. *Moment-generating function. *Quasiprobability distribution. *Riemann- ... 10.4 Related to Bernoulli trials (yes/no events, with a given probability) ... the outcome of a single Bernoulli trial (e.g. success/failure, yes/no) ...
The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... started publishing research on the topic and also published a book "Vitamin C and the Common Cold" in 1970.[28] A revised and ... A meta-analysis of 44 clinical trials has shown a significant positive effect of vitamin C on endothelial function when taken ... cannot be recommended outside of a clinical trial."[43] A 2015 review added: "There is no high-quality evidence to suggest that ...
... a phase II trial". Journal of Clinical Oncology. 23 (10): 2332-8. doi:10.1200/JCO.2005.51.008. PMID 15800324.. ... Scholia has a topic profile for Cholangiocarcinoma.. *American Cancer Society Detailed Guide to Bile Duct Cancer. ... American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 35 (36): e194- ... and enrollment in clinical trials is often recommended when possible.[76] Chemotherapy agents used to treat cholangiocarcinoma ...
Standards for Clinical-Trial Agreements with Industry". New England Journal of Medicine. 352 (21): 2202-2210. doi:10.1056/ ... researchers from different areas who are brought together for several days of intensive discussions about a particular topic ... They further criticized the trial methodology stating that researchers are frequently restricted from contributing to the trial ... on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to ...
Bradley's Neurology in Clinical Practice: Expert Consult - Online and Print, 6e (Bradley, Neurology in Clinical Practice e- ... Walker, BD (2007 Aug-Sep). "Elite control of HIV Infection: implications for vaccines and treatment.". Topics in HIV medicine ... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ... Evian, Clive (2006). Primary HIV/AIDS care: a practical guide for primary health care personnel in a clinical and supportive ...
Ibanga H, Brookes R, Hill P, Owiafe P, Fletcher H, Lienhardt C, Hill A, Adegbola R, McShane H (2006). "Early clinical trials ... http://www.cdc.gov/tb/topic/vaccines/. pristupljeno 26. srpnja 2011.. *↑ "BCG Vaccine Usage in Canada -Current and Historical" ... 59,0 59,1 59,2 ,National Institute for Health and Clinical Excellence. Clinical guideline 117: Tuberculosis. London, 2011. ... "Clinical infectious diseases: an official publication of the Infectious Diseases Society of America. svezak 45 (broj 4): str. ...
20-year results of a randomized trial". Journal of Clinical Oncology. 32 (8): 791-7. doi:10.1200/JCO.2013.50.6600. PMID ... Wikibooks has a book on the topic of: Radiation Oncology. Information. *Human Health Campus The official website of the ... Ang, K. Kian (October 1998). "Altered fractionation trials in head and neck cancer". Seminars in Radiation Oncology. 8 (4): 230 ... Academic Clinical Oncology and Radiobiology Research Network: A NCRI initiative to revitalise radiation therapy research (UK) ...
The goal of this document is to discuss the evidence and reasons behind disparities in clinical trial participation. We also ... Regardless of the cause, the lack of participation of these groups in clinical trials raises important questions about the ... by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. ... provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical ...
Participating in an observational study or a controlled clinical trial may involve a time commitment and some risks. However, ... Browse by Topic. * Heart Health « Back. *Blood Pressure. *Cholesterol. *Coronary Artery Disease ... What clinical trials can do for you. Participating in a medical study may benefit your health and perhaps that of millions of ... "Clinical trials are the vehicle by which we transfer things that we think into things that we know or dont know," says Dr. ...
Please find clinical trials at HSS listed by the following topics or view the full directory. ... APS ACTION (Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking) International Clinical ... Please visit the Mary Kirkland Center for Lupus Research and the Lupus Clinical Trials Consortium for more information on lupus ... Non-orthopedic and non-rheumatologic clinical trials are conducted at Weill Cornell Medical College, an affiliate of Hospital ...
Clinical Applications of Stem Cell Research. Catriona Jamieson. November 11, 2009 Program: Stem Cell Meeting on the Mesa 2009. ...
U.S. NIH: Stem Cell Information: Clinical Trials. *U.S. FDA: FDA Warns About Stem Cell Therapies ...
As the vast majority of drugs tested in small animal cancer models fail in human clinical trials, there is a need for large ... Utilization of large animal models also allows for testing of the same devices and tools used in human clinical practice in ... animal models to translate results obtained in small animal models to human clinical practice. In addition, the majority of ... futuristic perspectives with respect to the emerging requirements of large animal cancer models to address unmet clinical needs ...
... information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ... Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower. The safety and scientific validity of this ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668668 ... Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity ...
... the PIs rights to discuss or publish trial results after the trial is completed. ... USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 (IVERCAR). The safety and scientific validity ...
... laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. ... Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials.  Khan, MS; Krasuski, Richard ... committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. ... A model for harmonizing flow cytometry in clinical trials.  Amos, M; Aranda, R; Banchereau, J; Boshoff, C; Braun, J; Cho, J; ...
Clinical Trials as Topic Colitis, Ulcerative - drug therapy Double-Blind Method Enema Female Humans Male Mesalamine Proctitis ... Clinical Trials as Topic Denmark Humans Netherlands PubMed ID. 22745975 View in PubMed ... Clinical Trials as Topic Crohn Disease - drug therapy Drug Evaluation Humans Metronidazole - therapeutic use Sulfasalazine - ... Clinical Trials as Topic Denmark Femoral Fractures - blood - epidemiology - etiology Great Britain Humans ...
Timely topics in statistical methods for clinical trials. Annu Rev Biophys Bioeng. 1982; 11:81-104. ... Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards ...
Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182. NCCIH ... Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) ... The clinical significance and, when applicable, the biological relevance of the future clinical trial must be clearly stated. ... Future Clinical Trial: A concise summary of the subsequent proposed trial should be provided including the study design ( ...
Research on Current Topics in Alzheimers Disease and Its Related Dementias (R01 Clinical Trial Optional) PAR-18-596. NIA ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy ...
Clinical Trials, Phase II as Topic*Clinical Trials, Phase II as Topic ... "Clinical Trials, Phase II as Topic" by people in this website by year, and whether "Clinical Trials, Phase II as Topic" was a ... "Clinical Trials, Phase II as Topic" is a descriptor in the National Library of Medicines controlled vocabulary thesaurus, MeSH ... Below are the most recent publications written about "Clinical Trials, Phase II as Topic" by people in Profiles. ...
Female Contraceptive Trials Topic Area). Access many more Professional, Administrative, Management, Special Studies Awards , ...
... is expected to begin a phase 1 trial this fall on a potential vaccine for the treatment of Ebola virus, a deadly disease that ... GSK clinical trial may start this fall for Ebola vaccine. @media screen and (max-width: 468px) { .video-detail .doc-group- ... Cardiovascular Clinical Consult DiabetesGenericsGut HealthImmunizationOncologyRespiratoryShinglesTechnologyThoughtSpot 2020. ... Clinical. AnticoagulantsAutoimmune DiseasesBiosimilarsCardiovascular DiseaseCBDCOPD ManagementCoronavirusDermatologyDiabetes ...
3rd KCE Trials symposium - Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Trial Data ... 3rd KCE Trials symposium - Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Trial Data ... KCE Trials invites you to subscribe to the Symposium: Hot Topics in Clinical Trials: Developing Research Agendas, New Methods ... Status and impact of sharing of clinical trial data. Christian Ohmann, ECRIN, formerly University of Duesseldorf, Clinical ...
I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the clinicaltrials.gov website. Is ... Update on my anti-PD-1 clinical trial (MK 3475): I had my twelve-week scans this week. Everyone, including the doctors, trial ... Anti-PD-1 Immunotherapy Clinical Trial Update Portal › Forums › Lung/Thoracic Cancer › NSCLC › Stage IV NSCLC › Anti-PD-1 ... There was an earlier discussion of comparable trials here:. http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/ ...
A summary of clinical trial results is insufficient. The scientific data generated in clinical trials data are a public good. ... Transparent, independent health authorities: The worldwide debate on access to clinical trial data. Clinical trials regulation ... Access to all the data from clinical trials, in the form of clinical study reports, is crucial to ensure the reliability of ... Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives ...
... 0-9. A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P ... Meeting on the Revision of Guidelines for Clinical Research on Acupuncture, Seoul, Republic of Korea, 24-26 August 2005 : ...
In the Nov. 10 SN: Real benefits of virtual therapy, monkey malaria in humans, round electrons disappoint, mouse pups with two dads, bats hover techniques, Europas icy spikes, a vampire burial and more. ...
In the June 8 SN: Measles roars back, collapsars spin gold, a new kind of dementia, the Southern Oceans secrets, Denisovans lived on top of the world, and more. ...
Clinical trials registration. The mission of the WHO International Clinical Trials Registry Platform (ICTRP) is to ensure that ... Research policy topics. Strategy on research for health. WHO is currently working on a Research Strategy. The paper will focus ... IGPH aims to provide information and facilitate the application of genomics-based knowledge and technologies in clinical and ...
FDA and University of Maryland CERSI Lecture on Ensuring Accuracy in Clinical Trial Publications: Weighing Options by Peter ... Doshis lecture, he and a colleague have published an editorial on this topic in The BMJ:. PDoshi and FGodlee, The wider role ... particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and ... He is an advocate for greater public access to clinical trial data. Dr. Doshi also has strong interests in journalism as a ...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , Guidance for Industry, Investigators ... Search General and Cross-Cutting Topics Guidance Documents. *Advisory Committee Guidance Documents ... Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice ... FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, ...
Topic(s). * HEALTH.2012.1.4-4 - Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach ... We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. ... A phase I/IIa clinical trial in Duchenne muscular dystrophy using systemically delivered morpholino antisense oligomer to skip ... 2 Phase Ib and 2 Phase IIa clinical trials (MDEX Consortium in collaboration with Sarepta Therapeutics; a Dutch Consortium) ...
Topic(s). * LSH-2002-2.3.0-2 - HIV microbicides Call for proposal. FP6-2003-LIFESCIHEALTH-3. See other projects for this call ... The results of NeutNet will benefit HIV vaccine research and clinical trials making it possible to compare all vaccine effort s ... STANDARDISATION OF HIV NEUTRALISATION ASSAYS TO BE USED IN VACCINE RESEARCH AND CLINICAL TRIALS. ... aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of ...
Clinical Trials as Topic ✖Remove constraint Subjects: Clinical Trials as Topic Genre Congresses ✖Remove constraint Genre: ... 1. The practicing physician and clinical research Publication:. [Bethesda, Md. : Medical Arts and Photography Branch, National ...
"Clinical tests showed that hardware and software could be adjusted to the specific characteristics of these subjects providing ... "Clinical tests showed that hardware and software could be adjusted to the specific characteristics of these subjects providing ... Specifically, all subjects who had been mobile before the trial seemed to improve their walking speed and/or balance during ...
Clinical trials to test new drugs, devices or treatments are not only expensive, they are also risky for the test subjects; ... clinical trials.. "The primary users of in silico clinical trials technologies will be the biomedical industries", explains Dr ... Clinical trials to test new drugs, devices or treatments are not only expensive, they are also risky for the test subjects; ... "New medical treatments and devices are being tested in vitro - in a test system, and/or in vivo - clinical trials in living ...
Key Statistical Concepts in Clinical Trials for Pharma book. Read reviews from worlds largest community for readers. This ... There are no discussion topics on this book yet. Be the first to start one » ... Key Statistical Concepts in Clinical Trials for Pharma by J. Rick Turner ... To ask other readers questions about Key Statistical Concepts in Clinical Trials for Pharma, please sign up. ...
Search our research on a range of topics like radiotherapy, drug discovery and immunotherapy. ... Clinical Trials Find out more about some of the clinical trials we support. Clinical trials are vital for improving cancer ... From studies of the intricate workings of molecules within cells to the results of large-scale clinical trials of treatments, ...
  • We also provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of financial incentives, the impact of a more stringent policy and review process for product approval from the Food and Drug Administration (FDA) including a diversity mandate with an associated population black box warning. (intechopen.com)
  • A clinical trial is a research study on human volunteers designed to answer specific health questions. (peacehealth.org)
  • Clinical trials compare the effectiveness of the study medicine or treatment against standard, accepted treatment or a placebo. (peacehealth.org)
  • T