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. ( 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 / - 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 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 ...
Define tribulation. tribulation synonyms, tribulation pronunciation, tribulation translation, English dictionary definition of tribulation. n. 1. Great affliction, trial, or distress; suffering: a time of great tribulation. See Synonyms at trial. 2. An experience that tests ones endurance,...
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 clinical trials are research studies conducted in human volunteers. They aim to evaluate the efficacy and safety of certain drugs, treatment approaches, surgical techniques, or behavioural interventions to see if they will benefit those who are facing cancer.. At the Ottawa Regional Cancer Foundation, we are committed to providing consistent funding to clinical trials offered at The Ottawa Hospital, to make sure local patients have access to the most promising new cancer treatments. Supporting Ottawas clinical trials program means that more studies are opened right here in our community, and our loved ones and neighbours dont need to travel to larger cities like Montreal or Toronto to receive their treatments.. For many patients, treatment offered on a clinical trial can drastically improve their quality of life, lessen their treatment side-effects, help them live longer, or put their cancer in remission. Clinical trials can often be offered for cancers at any stage, whether the patient ...
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 ...
TY - JOUR. T1 - Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint. AU - and I-SPY 2 Investigators. AU - Boughey, Judy C.. AU - Alvarado, Michael D.. AU - Lancaster, Rachael B.. AU - Fraser Symmans, W.. AU - Mukhtar, Rita. AU - Wong, Jasmine M.. AU - Ewing, Cheryl A.. AU - Potter, David A.. AU - Tuttle, Todd M.. AU - Hieken, Tina J.. AU - Carter, Jodi M.. AU - Jakub, James W.. AU - Kaplan, Henry G.. AU - Buchanan, Claire L.. AU - Jaskowiak, Nora T.. AU - Sattar, Husain A.. AU - Mueller, Jeffrey. AU - Nanda, Rita. AU - Isaacs, Claudine J.. AU - Pohlmann, Paula R.. AU - Lynce, Filipa. AU - Tousimis, Eleni A.. AU - Zeck, Jay C.. AU - Lee, M. Catherine. AU - Lang, Julie E.. AU - Mhawech-Fauceglia, Paulette. AU - Rao, Roshni. AU - Taback, Bret. AU - Chen, Margaret. AU - Kalinsky, Kevin M.. AU - Hibshoosh, Hanina. AU - Killelea, Brigid. AU - Sanft, Tara. AU - Hirst, Gillian L.. AU - Asare, Smita. AU - Matthews, Jeffrey ...
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
MANHATTAN BEACH, Calif., Jan. 8, 2013 /PRNewswire/ -- Increased Clinical Trial Participation Needed To Improve Survival Of Pancreatic Cancer, The Fourth...
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 ( 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 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 ...
International Journal of Clinical Trials (IJCT) is an open access, international, peer-reviewed journal that encompasses all aspects of clinical trials. The journals full text is available online at The journal allows free access to its contents, offers a way to make data both freely available and highly visible worldwide; this will benefit the impact of your publication. International Journal of Clinical Trials is dedicated to publishing articles on clinical trial methodology as well as protocols, commentaries and results papers. International Journal of Clinical Trials (IJCT) is one of the fastest communication journals and articles are published online within short time after acceptance of manuscripts, this will benefit the societies by getting faster access to your clinical trial results. The journal has a broad coverage for articles are clinical trial methodology, traditional results papers, regulatory aspects of clinical trial, research ethics, clinical trial
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.
Join this free webinar to learn how risk-based management tools can simplify clinical trial data management for CROs and sponsors of pharmaceutical and medical device companies
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…
Our clinical trials recruit over 25,000 patients every year. Clinical trials are vital for developing new treatments, making sure they are safe and effective.
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
Clinical research funding comes from several sources, such as federal institutions, like the National Institutes of Health (NIH), the Department of Defense … Clinical Studies From the name of the trial to the last words on the page, looking at a clinical study recruitment website or form can be intimidating. There are always at least three phases to clinical trials. Clinical Research Phase Studies Phase 1 Study Participants: 20 to … An investigational product can be evaluated in more than one phase simultaneously in different clinical trials, and some clinical trials may overlap two different phases. By combining trial phases, drug manufacturers hope to speed up the development timelines for new drugs. All clinical trials of new medicines go through a series of phases to test whether theyre safe and whether they work. These phases will also determine whether producing the treatment is feasible , meaning it is not only possible but practical, as well. Understanding how clinical trials work ...
A new high-end research report documentation estimating multiple developments and growth touchpoints has been included in the versatile report repository. At the backdrop of steaming competition and fast growing vendor landscape with the addition of new players in the competition isle, this report on global Clinical Trial Management (CTM) market is an ideal tool to allow market players in designing novel investment plans to revive growth.. The report is a highly influential document to understand the caliber of various market participants in ensuring thumping growth. Besides analyzing the growth potential of established players this report is a standalone reference guide to review the potential of novel market participants in incurring valuable disruptions in the competition space, on the back of rapid technological milestones, fast changing policies and regulatory framework as well as transitioning end-user preferences.. Vendor Landscape. ...
Eclipse Clinical Technologys Clinical Trial Management System is a scalable, secure and regulatory compliant cloud-based solution that provides quality monitoring in real-time. Check us out!
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.
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, 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 ( This searches records from national and international trial registries that meet certain standards, including WHO Primary Registries and 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.
Despite a growing interest in, and commitment to, implementing pediatric clinical trials, approximately one in every five trials in children fails because of inappropriate study design, suboptimal experiment planning, or inadequate participant enrollment. This tutorial, presented from the perspectives of seasoned pediatric investigators, an experienced research coordinator, and an established pediatric clinical trials network, is designed to provide practical guidance for successfully implementing pediatric clinical trials at an academic center or another comparable institution.
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.
© 2020 Elsevier Ltd Background: Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. Methods: We downloaded data for all registered trials on each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due
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
The Association of Clinical Research Professionals (ACRP) is officially partnering with the European Clinical Research Infrastructures Network (ECRIN) in honoring the extraordinary contributions of clinical researchers worldwide on International Clinical Trials? Day.
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, ...
On November 21, 2014, the National Institutes of Health (NIH) published a notice of proposed rulemaking that would expand the registration and results reporting provisions first created by the Food and Drug Administration Amendments Act (FDAAA) in 2007. (Notice available here.) NIH would require posting of results for clinical trials of unapproved and uncleared products. NIHs action follows the October 2, 2014 release of the European Medicines Agencys (EMAs) policy on the publication of clinical trial data. The current NIH proposal would not go as far as the EMA policy, which will require the EMA to publish clinical reports, and eventually individual patient data, that are submitted to the Agency in marketing authorization applications (The EMA Policy is available here). Such a requirement is still a possibility in the United States, however, as the Food and Drug Administration (FDA) has considered whether this might be appropriate under certain limited circumstances. In ...
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 ...
An HIV vaccine clinical trial is no longer happening after researchers found the vaccine ineffective in preventing new HIV infections. The National Institute of Allergy and Infectious Diseases (NIAID) had sponsored the trial and announced it was…
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 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
STI571 (Gleevec) is a member of the 2-phenylaminopyrimidine family of adenosine triphosphate (ATP) binding site inhibitors of protein tyrosine kinase. It potently inhibits the tyrosine kinase activity of Abl and Bcr-Abl,[1-3] platelet-derived growth factor receptor (PDGF-R), and Kit (stem cell factor receptor).[4-6]
"VivaGel™ - Clinical trials Under Way". Star Pharma. Archived from the original on 7 January 2008. Retrieved 1 April 2018. ... World Health Organization (2002). "HIV/AIDS Topics: Microbicides". Geneva: World Health Organization. Retrieved August 28, 2006 ... "Microbicide Clinical Trials". AVAC. Archived from the original on 16 July 2011. Retrieved 1 April 2018. Global Campaign for ... Additionally, clinical trials have not demonstrated these agents to be effective at preventing HIV transmission.[citation ...
Safer and more effective clinical trials. Evolution[edit]. This section may stray from the topic of the article. Please help ... "Journal of Evaluation in Clinical Practice. 18 (1): 56-62. doi:10.1111/j.1365-2753.2010.01522.x. ISSN 1365-2753. PMID 20698917. ...
"Clinical Trials". Lupo JM, Chen AP, Zierhut ML, Bok RA, Cunningham CH, Kurhanewicz J, Vigneron DB, Nelson SJ (February 2010). " ... Topics in Magnetic Resonance Imaging. 25 (1): 31-7. doi:10.1097/RMR.0000000000000076. PMC 4968075. PMID 26848559. " ... The majority of clinical studies utilizing 13C hyperpolarization are currently studying pyruvate metabolism in prostate cancer ...
... clinical research including clinical trials; endocrinology; epidemiology and prevention; experimental therapeutics, molecular ... Some of the topics include biochemistry; chemical, physical, and viral carcinogenesis and mutagenesis; ... Educational Workshops that train early-career investigators in clinical trial design, molecular biology, integrative molecular ... Based in Philadelphia, the AACR focuses on all aspects of cancer research, including basic, clinical, and translational ...
2020). "Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials". Current Topics in Medicinal Chemistry. 20 (6 ... It is the first telomerase inhibitor to enter clinical trials. It is currently in Phase 2/3 trials for various cancer types. ...
On this topic he conducted several randomized clinical trials and published books. In 2015 the Cochrane Review published an ... compression treatment: a randomized clinical trial". European Journal of Vascular and Endovascular Surgery. 25 (4): 313-318. ... "A phase II randomized clinical trial for the treatment of recalcitrant chronic leg ulcers using centrifuged adipose tissue ... Space trials involved the Italian astronaut Samantha Cristoforetti. Zamboni also described other anomalies of cerebral venous ...
Clinical Cancer Research; Clinical Trials. 6 (7): 2677-84. PMID 10914709. Avendano, Carmen; Menendez, J. Carlos (April 2008). ... Cancer Topics - Coping with Cancer. National Cancer Institute. Retrieved 1 December 2008. McLeod HL, Cassidy J, Powrie RH, ... In clinical trials for mesothelioma, folic acid and B12 supplementation reduced the frequency of adverse events.) It is also ... NCCN Clinical Practice Guidelines in Oncology: Non-small Cell Lung Cancer V.2.2009 available from Gandhi, Leena; ...
... developed using viral vectors and a number of pharmaceutical proteins are currently in pre-clinical and clinical trials.[241] ... Current Topics in Microbiology and Immunology. 2008;325:263-79. doi:10.1007/978-3-540-77349-8_15. PMID 18637511. ... Having completed successful clinical trials, this virus is expected to gain approval for the treatment of a skin cancer called ... Current Topics in Microbiology and Immunology. 2006;304:17-29. doi:10.1007/3-540-36583-4_2. PMID 16989262. ...
... a systematic review of randomized clinical trials" (PDF). British Journal of Anaesthesia. 84 (3): 367-71. doi:10.1093/ ... Over 30 definitions of nausea were proposed in a 2011 book on the topic. Nausea is a non-specific symptom, which means that it ... "Bulimia Nervosa-Topic Overview". WebMD. Archived from the original on 25 July 2012. Retrieved 26 July 2012. The dictionary ... a meta-analysis of randomized controlled trials". Acta Anaesthesiologica Scandinavica. 46 (3): 238-44. doi:10.1034/j.1399- ...
Lechat, P. (2008). "Clinical pharmacology of beta-blockers in cardiology: trial results and clinical applications". Hot Topics ... Clinical trials started in the summer of 1964 and a year later, propranolol was launched under the trade name Inderal, only two ... The launch took place in November 1963 when many small-scale clinical trials had proved their effectiveness in angina and ... Although DCI had no clinical utility, a change in the compound did provide a clinical candidate, pronethalol, which was ...
It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ... "Efficacy Study of LY2422347 to Treat Insomnia - Full Text View -". "Eli Lilly and Company » Research ...
Clinical trials have been initiated to test the effectiveness of certain worms in treating some allergies. It may be that the ... For more information on this topic, see Helminthic therapy. In the early stages of allergy, a type I hypersensitivity reaction ... The authors concluded that, based on rigorous clinical trials of all types of homeopathy for childhood and adolescence ailments ... systematic review of randomized clinical trials". Mayo Clinic Proceedings. 82 (1): 69-75. CiteSeerX doi: ...
Various clinical trials are also run out of the centre. Research is conducted through the Odette Cancer Centre research program ... Research spans from the topics of basic genetics, biochemistry and biology of cancer. The program provides critical care and ... "About clinical trials - Odette Cancer Centre - Sunnybrook Hospital". Retrieved February 14, 2018. "Odette Cancer ...
In preliminary clinical trials, they have proven effective for the treatment of irritable bowel syndrome.[60] Examples of ... In: Spiller GA (ed) Topics in dietary fiber research. Plenum Press, New York, pp. 127-68 ... controlled trial". Clinical Gastroenterology and Hepatology. 3 (4): 358-69. doi:10.1016/S1542-3565(04)00672-X. PMID 15822041.. ... "The Journal of Clinical Endocrinology and Metabolism. 97 (9): 3326-32. doi:10.1210/jc.2012-1513. PMID 22745235.. ...
Schiebinger L (October 2003). "Women's health and clinical trials". The Journal of Clinical Investigation. 112 (7): 973-7. doi: ... This topic alone sparked controversy and brought about question to the medical standard of our time. Popular media has ... "Systematic Review of Gender Bias in the Clinical Trials of New Long-Acting Antipsychotic Drugs". Journal of Clinical ... In 2018 the US FDA released draft guidelines for inclusion of pregnant women in clinical trials. In a 2019 meta-analysis it was ...
Since 1992, the journal has published the proceedings of Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) ... The Journal of Rheumatology is a peer-reviewed medical journal addressing topics in rheumatology and arthritis. It is an ...
Her current research funding is for clinical trials in breast cancer metastasis and idiopathic normal pressure hydrocephalus. ... She is the author of dozens of papers, invited lectures and courses in these topics, including a co-authored white paper with ... She writes and speaks often in the U.S. and abroad on neurosurgical topics. Her most frequent subjects include innovative ... Gail Linskey Rosseau (born c. 1956) is Clinical Professor of Neurosurgery at George Washington University School of Medicine ...
Importantly, clinical trials for the drug in patients with ischemic stroke show it to be effective as well as noninvasive. ... Glutamate antagonists are a hot topic of research. Below are some of the treatments that have promising results for the future ...
Karonudib, an MTH1 inhibitor, is currently being evaluated a phase I clinical trial for safety and tolerability. A potent and ... Research into this topic is ongoing. MTH1 is a potential drug target to treat cancer, however there are conflicting results ... This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". U.S. National ...
... clinical trials; health and adverse effects; fortification; traditional Chinese medicine and other folk/ethnic supplement ... The subset will retrieve dietary supplement-related citations on topics including, but not limited to: chemical composition; ...
See Trivia, and avoid useless statements like "More research is needed". Wikipedia is not a directory of clinical trials or ... To create a new topic, slick [new section] at the top of the page, give the section a title, and leave your comment. New topics ... For example, the results of an early-stage clinical trial are unlikely to be appropriate for inclusion in the Treatment section ... In medicine, primary sources include clinical trials, which test new treatments; secondary sources include meta-analyses, which ...
... whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license ... The CIOMS, a part of the WHO, is globally oriented think tank that provides guidance on drug safety related topics through its ... The variables in a clinical trial are specified and controlled, but a clinical trial can never tell you the whole story of the ... Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies ...
From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... In a Good Manufacturing Practice regulated industry, the topic is frequently encountered by its users. Various industrial ... "Guidance for Industry: Computerized Systems Used in Clinical Trials" (PDF). U.S. Food and Drug Administration. April 1999. ...
... which are much higher than those seen in randomized clinical trials[62] have been the topic of extensive debate and discussion. ... The author of one study argued that adverse events are more common in clinical practice than in randomized clinical trials.[56] ... Norata GD, Tibolla G, Catapano AL (October 2014). "Statins and skeletal muscles toxicity: from clinical trials to everyday ... Randomized controlled trials have found these foodstuffs to reduce circulating cholesterol, but the quality of the trials has ...
... results of clinical trials, and research findings. Ophthalmology also publishes major reviews of specific topics by ... Topics include new diagnostic and surgical techniques, treatment methods, instrument updates, the latest drug findings, ...
... is also a popular topic of research and has led to several stage III clinical trials. Invasiveness is not an issue here because ... Because of this, only 3.6% of clinical trials in this field have progressed to stage III since the concept of gene therapy was ... This proves further long term in vivo studies are needed to gain enough understanding to allow for successful clinical trials. ... The specific topics that form the main foci of research change over time, driven by an ever-expanding base of knowledge and the ...
In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... However, their prospects are unclear List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). " ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ...
It has performed well in clinical trials for ear infection and looks likely to be further developed in future. It is only ... El-Gamal MI, Oh CH (2010). "Current status of carbapenem antibiotics". Current Topics in Medicinal Chemistry. 10 (18): 1882-97 ... Sugita R (June 2013). "Good transfer of tebipenem into middle ear effusion conduces to the favorable clinical outcomes of ...
They work together to assess the evidence for the guideline topic (e.g. clinical trials of competing products) before preparing ... Before an appraisal, the Advisory Committee on Topic Selection (ACTS) draws up a list of potential topics of clinical ... It was set up as the National Institute for Clinical Excellence in 1999, and on 1 April 2005 joined with the Health Development ... The idea of what was originally termed a National Institute for Clinical Excellence took root when Labour came to power in 1997 ...
... 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. ...
In clinical trials involving more than 10,000 people, the vaccine, called LYMErix, was found to confer protective immunity to ... "CDC - Lyme Disease - NIOSH Workplace Safety and Health Topic". 3 August 2017. Archived from the original on 13 ... "European Journal of Clinical Chemistry and Clinical Biochemistry (Submitted manuscript). 32 (9): 685-9. doi:10.1515/cclm. ... Stanek G, Reiter M (April 2011). "The expanding Lyme Borrelia complex--clinical significance of genomic species?". Clinical ...
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 ...
The Medicines for Human Use (Clinical Trials) Regulations 2004. *The Medicines for Human Use (Clinical Trials) Amendment ... ICH Topic E 6 (R2). *Good Clinical Practice (from U.S. Food and Drug Administration) ... The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the ... clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. ...
... 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 ... *^ ... 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. ... 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 - - 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 " ... 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 ...
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. ...
Interventional (Clinical Trial) Actual Enrollment :. 44 participants. Allocation:. Randomized. Intervention Model:. Parallel ... Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy. The safety and scientific validity of this ... MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders Drug Information available for: Tromethamine Ketorolac ... Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient. ...
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 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 ...
The R + Fenretinide Clinical Trial. This is a Phase-2 clinical trial, recruiting patients with B-cell cancers (CLL patients as ... I urge you to read it carefully, if you are interested in this clinical trial. Unfortunately, since this clinical trial ... CLL Topics is proud to announce our sponsorship of a brand-new Phase II clinical trial that has just opened for recruitment at ... Dont be shy about it! Volunteering to participate in clinical trials is a big deal and it is very important that you get your ...
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 ...
... phase I/II clinical trial Bo Zhang, Jing Huang, Jialin Tang, Sheng Hu, Suxia Luo, Zhiguo Luo, Fuxiang Zhou, Shiyun Tan, Jieer ... Clinical efficacy of T-cell therapy after short-term BRAF-inhibitor priming in patients with checkpoint inhibitor-resistant ... Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer ... Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of breast cancer ...
I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the 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:. ...
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 ...
  • February 02, 2018 - Notice to Specify High-Priority Research Topics for PAR-18-596. (
  • Further information on the high priority topics of interest will be announced through a series of notices published in late January and early February of 2018. (
  • GlaxoSmithKline (GSK) with its partner, the National Institute of Allergy and Infectious Diseases (NIAID), is expected to begin a phase 1 trial this fall on a potential vaccine for the treatment of Ebola virus, a deadly disease that has killed approximately 1,000 in a recent outbreak in West Africa, according to a report by Reuters. (
  • In preclinical trials in primates, GSK's vaccine has shown promise, according to the NIAID. (
  • The results of NeutNet will benefit HIV vaccine research and clinical trials making it possible to compare all vaccine effort s throughout Europe and beyond. (
  • Data from HIV-1 antibody-negative men (n = 698) enrolled in Project ACHIEVE in New York City were analyzed to assess willingness to participate in efficacy trials, factors influencing willingness, and the effect on willingness of the June 1994 media events about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials. (
  • Focus group discussions were conducted to assess factors that might impact participation of subgroups in Chennai for future HIV vaccine trials. (
  • Participants expressed an intense interest in future HIV vaccine trials. (
  • This entry was posted in Clinical Trials & Studies , Featured Posts , Pharmaceuticals , Science and tagged #covid19 , #diaryofaplagueyear , COVID-19 , Covid-19 vaccine , vaccines . (
  • This is a list of vaccine -related topics . (
  • Adenovirus Vaccine Efficacy Trial Consortium (2013). (
  •,viruses%20in%20the%20same%20family.&text=Nipah%20virus%20is%20a%20type,transmitted%20from%20animals%20to%20humans. (
  • As the vast majority of drugs tested in small animal cancer models fail in human clinical trials, there is a need for large animal models to translate results obtained in small animal models to human clinical practice. (
  • This Research Topic will also address training needs with regards to comparative pathology and the development of imaging standards to support relevant interpretation of findings and expedite the launch of human clinical trials. (
  • NeutNet, a group of 13 participants from all over the world, proposes to co-ordinate activities aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines. (
  • ROCKVILLE, MD - A drug and drug delivery candidate technology, research into which has been funded by the National Foundation for Cancer Research (NFCR), has recently been approved by the U.S. Food and Drug Administration (FDA) for the initiation of human clinical trials. (
  • April 12, 2017 - Notice of Informational Webinars for Investigators Applying for NCCIH Clinical Trials. (
  • Findings from the DEFINE FLAIR and iFR Swedeheart trials, which studied 4,529 patients as part of the largest randomized coronary physiology outcome studies to date, were presented at the 2017 American College of Cardiology's Annual Scientific Session & Expo (ACC.17) in Washington, D.C., March 17-19, 2017. (
  • The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy. (
  • This trial may well be that goldilocks scenario we have been looking for, a way of improving the efficacy of Rituxan without increasing toxicity. (
  • This funding opportunity is intended to support exploratory clinical trials, which will provide data that are critical for the planning and design of a subsequent controlled cohort study, clinical efficacy or effectiveness study, or a pragmatic trial. (
  • This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy or effectiveness. (
  • Access to all the data from clinical trials, in the form of clinical study reports, is crucial to ensure the reliability of pharmaceutical safety and efficacy data and to respect patients who participate in clinical trials. (
  • A recent study published in BMJ open has shown that clinical study reports are comprehensive documents of on average 1 800 pages, containing the following sections: report synopses (about 5 pages), efficacy evaluation (about 13 pages), safety evaluation (17 pages), trial protocol (about 60 pages), and the remaining pages are attached tables and anonymised individual efficacy and safety listings (8). (
  • In numerous cases, data from unpublished and misreported trials has vastly changed our understanding of the safety and efficacy of specific drugs. (
  • These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance. (
  • This designation prescribes an accelerated development pathway for FDA approval that determines efficacy based on two different validated animal studies followed by clinical evaluation in phase I and phase II trials to establish safety and immunogenicity for use in humans. (
  • However, improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed over background medication, suggesting that elevated TLR3 gene signatures previously observed in UC patients, as well as in PULSE, are downstream or circumstantial effects that do not contribute significantly to causal pathology. (
  • The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (See Food and Drug Administration). (
  • Efficacy trials of candidate HIV-1 vaccines require study populations at high risk of infection who adhere to study protocols and who are willing to participate. (
  • In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. (
  • Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g. (
  • citation needed] Carrageenan preparations (such as 0.5% PRO 2000 and 3% Carraguard vaginal microbicide gels) have failed to demonstrate efficacy in preventing HIV transmission in phase III clinical multicenter trials. (
  • Similarly, the phase III efficacy trial of Carraguard showed that the drug was safe for use but ineffective in preventing HIV transmission in women. (
  • Utilization of large animal models also allows for testing of the same devices and tools used in human clinical practice in species with similar size, anatomy, physiology, metabolism, immunology, and genetics compared to humans. (
  • IGPH aims to provide information and facilitate the application of genomics-based knowledge and technologies in clinical and public health practice. (
  • When the completeness or accuracy of the medical literature - particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and systematic reviews. (
  • The affirmative decision of the IRB that the clinical trial has been reviewed (i.e. protocol, informed consent(s), conflict of interests, etc.) and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. (
  • Together the results of these studies demonstrate large simple trials in clinical practice can be done, and should remove any barriers to the use of coronary physiology in interventional procedures. (
  • He is a Director of the Scientific Archivists Group, Co-Lead for the SAG GCP Special Interest Group, and former Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. (
  • We provide a suggested set of items for inclusion in clinical trial data sets that also are useful in clinical practice. (
  • This FOA encourages and provides a mechanism for the submission of applications for multi-center exploratory and confirmatory clinical trials focused on promising interventions, including pragmatic trials performed in large numbers of patients with minimal alteration from clinical practice and low per-patient costs. (
  • Micafungin Safety in Pediatric Patients in Clinical Practice. (
  • BACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. (
  • New medical treatments and devices are being tested in vitro - in a test system, and/or in vivo - clinical trials in living organisms. (
  • From studies of the intricate workings of molecules within cells to the results of large-scale clinical trials of treatments, every result helps to deepen our understanding of cancer and find new ways to fight it. (
  • Clinical trials are vital for improving cancer treatments and making them available to patients. (
  • The need for randomised trials to establish that treatments are effective is well established. (
  • The protocol says what kind of trial it will be, what it will study, who should be in the study, what treatments will be used, and how results will be measured. (
  • A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. (
  • Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. (
  • Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. (
  • A clinical trial is a study using people who agree to participate in new tests or treatments. (
  • Current cancer medicines, tests, and treatments used by most health care providers have been tested through clinical trials. (
  • Participating in a clinical trial may give you access to treatments that are not widely available elsewhere. (
  • Clinical trials are important because they compare new treatments with accepted treatments. (
  • Clinical trials are also important in finding treatments if no standard treatment exists. (
  • Although the purpose of trials is to find new and better treatments, the new treatment may not work as well as standard treatments. (
  • You'll want to know what exactly is involved, including potential risks, what treatments you might get, how long the trial will last, how often you'll need appointments, what your other responsibilities might be, and what happens after the trial ends. (
  • By doing clinical trials during this pandemic, we are trying to find treatments and, thereby, hope. (
  • However in 1995, Jack was diagnosed with Multiple Myeloma, which started him on a series of numerous treatments, including lots of chemotherapy, 3 stem cell transplants (2 auto's, 1 full allo), 4 rounds of radiation and 2 clinical trials. (
  • Patients who participate in clinical trials receive the most effective therapy currently available for their condition -- or they may receive treatments that are being evaluated for future use. (
  • The CF Foundation offers a number of resources for learning about clinical trials and treatments that are being developed to improve the treatment of cystic fibrosis. (
  • Clinical trials represent the first essential step toward the development of treatments targeting cancer and various diseases [ 1 , 2 ], and allow researchers to Test the effectiveness of preventive measures, treatments, screenings, and diagnostic techniques [ 3 ]. (
  • Conflicts of Interest and Outcomes of Cardiovascular Trials. (
  • Objective To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes. (
  • Outcomes in most trials were subjective-for example, qualitative assessment of the patient's function. (
  • 1 One challenge to the validity of such trials is the tendency for assessments of outcomes to systematically deviate from the truth because of predispositions in observers, such as from hope or expectation. (
  • Amsterdam, the Netherlands and Washington, D.C. - Royal Philips (NYSE: PHG, AEX: PHIA) today announced that the results from two large clinical trials comparing patient outcomes using instant wave-free ratio (iFR) and fractional flow reserve (FFR) in the diagnosis and treatment of heart disease have been published in the New England Journal of Medicine. (
  • Despite the critical relevance of smoking to cancer outcomes, most oncology clinical trials do not collect data on smoking history and status unless the malignancy is widely acknowledged as smoking related (e.g., lung or head and neck cancer). (
  • Changes in smoking status during treatment or follow-up are monitored in very few trials and are infrequently reported in sample descriptions or included in analysis plans as a potential moderator of outcomes. (
  • Based on mounting evidence that tobacco use affects cancer treatment outcomes and survival, we recommend that smoking history and status be systematically collected as core data in all oncology clinical trials: at diagnosis, at trial registration, and throughout treatment and follow-up to long-term survival or death. (
  • We feel that the inclusion and analysis of such data in clinical trials will add important information to the interpretation of outcomes and the development of scientific knowledge in this area. (
  • Also eligible are biomarker- and outcomes-validation studies that are immediately preparatory to trials in stroke prevention, treatment, or recovery. (
  • Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. (
  • Objectives: The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. (
  • Discussions about clinical trial participation are quite challenging due to the uncertainty regarding the outcomes of clinical trials, and the complex nature of consent documents [ 12 ]. (
  • I. Clinical caries studies]. (
  • Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. (
  • This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and irinotecan hydrochloride in treating younger patients with solid tumors that have come back or that have not responded to standard therapy. (
  • PURPOSE: This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). (
  • PURPOSE: This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). (
  • Eligibility criteria for selecting studies Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. (
  • We extend Lilford and others' proposal that a bayesian statistical approach, using related information from earlier studies, would be useful in designing and subsequently summarising small randomised controlled trials. (
  • can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. (
  • You also can find information online at and search for current and upcoming clinical studies around the world. (
  • In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomization). (
  • Findings from these two major clinical outcome studies have the potential to significantly improve the use of coronary physiological assessment," said Dr. Manesh Patel, MD, FACC, FSCAI, Chief of the Division of Cardiology and Co-Director of the Duke Heart Center at Duke University School of Medicine. (
  • Therefore, this Research Topic aims to bring the most recent discovery on the Sirt1 mechanisms involved in vascular protection, novel pharmacological molecules that target Sirt1 for the treatment of the atherosclerosis, and animal and clinical studies related to the effects of Sirt1 against atherosclerosis. (
  • The intention of this Research Topic is to receive manuscripts from bench to clinical studies of interventions associated with changes in Sirt1 levels and their pathophysiological importance in the atherosclerosis process. (
  • The network also relies on a statistical and clinical coordinating center to monitor trials and coordinate data from its studies. (
  • Clinical trials are research studies in which people help doctors find ways to improve health care. (
  • Recent studies of the treatment of obesity by moderate and severe caloric restriction show that patients treated in randomized trials using a conventional 1200 kcal/d reducing diet, combined with behavior modification, lose approximately 8.5 kg in 20 weeks. (
  • This entry was posted in Clinical Trials & Studies , Ethics , Featured Posts , Public Health , Research Ethics , Uncategorized and tagged #diaryofaplagueyear , COVID-19 , policy . (
  • This entry was posted in Clinical Trials & Studies , Conflict of Interest , Decision making , Featured Posts , Health Regulation & Law , Informed Consent , Social Justice and tagged #covid19 , #diaryofaplagueyear , COVID-19 . (
  • Others may consider use of PAR-17-274 , NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery and Prevention (U01). (
  • For this funding opportunity announcement, Phase I and II clinical studies or trials refer to the common phases of a clinical trial. (
  • In addition, the network will support studies to validate biomarkers with demonstrated promise to inform Phase 2 clinical trials. (
  • Primary and secondary prevention stroke trials - studies of agents, devices, or strategies to prevent recurrent stroke in survivors of stroke or transient ischemic attack (TIA), or to prevent first stroke in high-risk populations. (
  • The studies may range from concept to developmental phases, with a clear commercialization plan to enable healthcare providers to use them in regular clinical care settings in the population, which is the focus of this FOA. (
  • We understand that problems of patient recruitment and retention exist in all facets of clinical research, especially in studies on acute otitis media. (
  • Search for clinical trials, research studies and investigators by research topic. (
  • As far as regulatory bodies are concerned, the best evidence comes from well-controlled human clinical studies 1 , although this is not the only kind of acceptable evidence. (
  • Moreover, consistent data formatting across studies (e.g. across two or more phase 2 trials) sometimes appears to slow the process of trial completion. (
  • However, despite the evidence for the positive benefits of conducting clinical trials, and despite the overall agreement on the importance of clinical research (as evidenced by the Cancer Moonshot initiative and recent, highly funded efforts directed toward advancing precision medicine), researchers are limited by the low number of patients consenting to join clinical research studies [ 4 , 5 ]. (
  • Conversations with patients and their families intended to educate them about participation in clinical trials and research studies present unique challenges that differ significantly from typical exchanges in the provider‐patient encounter. (
  • With their unique mixes of varied contributions from Original Research to Review Articles, Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! (
  • As researchers, doctors, scientists, patients and civil society representatives we are asking you to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed. (
  • The disclosure of a summary of results, as suggested by the European Commission, is of little scientific value, as it does not supply healthcare professionals and independent researchers with the information they need to judge the merit of a trial or to be able to use its results to support rational prescribing. (
  • Establishing clinical study reports (CSR) or a full dataset as a disclosure format does not represent an added burden for academics or non---commercial researchers. (
  • Published clinical study results are increasingly published together with the full dataset of individual anonymised patients data: the researchers often simply upload the files containing their full dataset to the website of the publisher (9,10). (
  • A clinical trial is a study that researchers do to see whether a treatment (such as a new medicine, therapy, or surgery) works well and is safe. (
  • In a randomized, controlled clinical trial, researchers often are trying to find out if a treatment works. (
  • Therefore, the proposed Research Topic on Sirt1 may be of great interest to researchers in the field of chronic degenerative diseases and also of great impact to the section of "Cardiovascular and Smooth Muscle Pharmacology" of the journal Frontiers in Pharmacology . (
  • Clinical trials help researchers know whether a new treatment works well and is safe. (
  • A phase II trial includes more people as the researchers look at safety and how well the treatment works. (
  • Doctors, nurses, and researchers follow your health very closely during a clinical trial, says Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York. (
  • Through clinical trials , researchers test the effects of new medications on a group of volunteers with brain cancer. (
  • In May this year we asked patients, volunteers and researchers who have taken part in or helped to run clinical trials to tell us what questions and comments they have to keep people involved. (
  • The network is funded through contracts and utilizes a scientific advisory committee, composed of outside experts in the fields of basic and clinical contraceptive research, pharmacology, and epidemiology, to advise on research topics and directions. (
  • American Society of Clinical Oncology educational book. (
  • Most often, the CCC is headed by the Clinical Principal Investigator and is responsible for protocol development, clinical sites, and oversight of clinical study operations and facilities. (
  • He is the principal investigator on several clinical trials. (
  • You can search for trials near you or those looking for people like you. (
  • When experiments travel : clinical trials and the global search for human subjects / Adriana Petryna. (
  • This website, developed by the nonprofit Coalition of Cancer Cooperative Groups, is an unbiased cancer clinical trial matching and navigation service enabling patients to search for cancer trials based on disease and location. (
  • Find out more on how to host your own Frontiers Research Topic or contribute to one as an author. (
  • Exploratory clinical trials must include a clearly defined go/no-go pathway toward advancement to a future Phase 3 trial. (
  • The randomised clinical trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. (
  • The Phase 1b PULSE (Provention ULcerative colitis Safety/PK/PD Evaluation) clinical trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study that evaluated PRV-300 in 28 active, and 9 placebo, adult patients with moderate-to-severe ulcerative colitis. (
  • A placebo controlled randomized clinical trial of Crocus sativus L. (
  • A placebo controlled randomized clinical trial of Crocus sativus L. (saffron) on depression and food craving among overweight women with mild to moderate depression. (
  • Seventy-three women with BMI ≥ 25 comorbid with mild-to-moderate depression were recruited in this 12-week double-blind, placebo-controlled randomized clinical trial. (
  • Compliance with results reporting at (
  • BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to (
  • Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. (
  • Everyone, including the doctors, trial nurses, and my family and friends, was very anxious to see the results, as I am the first of the lung cancer arm to get my scans at my clinic. (
  • OLDWICK, N.J., May 8, 2019 /PRNewswire/ -- Provention Bio, Inc. PRVB, -4.93% a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced preliminary top-line results from its Phase 1b PULSE study which evaluated PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody, in patients with active, moderate-to-severe ulcerative colitis (UC). (
  • Will we be told about the trial results? (
  • Preliminary results from one of the earliest clinical trials of CRISPR-Cas9 provide evidence that the technique is safe and feasible to use for treating human diseases. (
  • After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. (
  • If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public. (
  • Phase 1 trial is they don't know what the results are going to be. (
  • Opt-e-scrip claims accuracy is improved by comparing new test results against its database of results from previous single-patient clinical trials. (
  • Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results? (
  • Results from Genmab's HuMax-CD20 Phase II Clinical Trial ) responding to his latest round of therapy with HuMax-CD20. (
  • PRO 2000 was demonstrated to be safe, but it did not reduce the risk of HIV infection in women (as explained in the MDP 301 trial results, released in December 2009). (
  • On February 1, 2007, the International AIDS Society announced that two phase III trials of cellulose sulfate had been stopped because preliminary results suggested a potential increased risk of HIV in women who used the compound. (
  • With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. (
  • The network is designed to increase the efficiency of stroke clinical trials by facilitating patient recruitment and retention, supporting novel methodologies and streamlined approaches to accelerate the development of promising stroke therapies, and enabling comparison between approaches. (
  • This is a waste of research money and an abuse of clinical trial participants' altruism and trust (1 to 5). (
  • In a randomized clinical trial, participants are assigned by chance to different treatment groups. (
  • The company sponsoring the trial will have a very strict set of standards, or criteria, that all participants must meet. (
  • What are the most important questions about how to encourage trial participants to stay involved? (
  • Design Systematic review of trials with both blinded and non-blinded assessment of the same binary outcome. (
  • Effect of socioeconomic status as measured by education level on survival in breast cancer clinical trials. (
  • I would like to thank the PULSE study patients, coordinators and investigators, as well as Provention's expert clinical development team, for their time, efforts, and dedication in conducting such a definitive, cost-effective, and efficient clinical trial,' said Ashleigh Palmer, CEO of Provention Bio. (
  • Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients. (
  • A randomized clinical trail led by Huntsman Cancer Institute investigators finds that a combinatorial chemotherapy reduces precancerous polyps by 75 percent in patients at high-risk for cancer. (
  • Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. (
  • A clinical trial will recruit many people to participate. (
  • One of the many benefits we can offer you is the chance to participate in clinical trials. (
  • We not only start clinical trials to improve the detection and treatment of thyroid cancer but also participate in most major thyroid cancer clinical trials taking place around the country. (
  • You should be fully informed about the possible risks of the trial before you agree to participate. (
  • Most trials take place at academic medical centers, often in cities. (
  • The NIH StrokeNet comprises a National Clinical Coordinating Center (NCC), a National Data Management Center (NDMC) and 25 geographically distributed Regional Coordinating Centers (RCC) with over 350 affiliated stroke centers. (
  • Some of the best CLL expert centers are participating in this trial. (
  • Even with the large number of centers participating in this trial, this would mean a significant amount of travel to and from the trial center for most of us and you should be prepared for that. (
  • Many physicians characterize discussions about research and clinical trials with patients as particularly challenging, a problem, which is rarely addressed, even by academic medical centers committed to the research enterprise [ 9 ]. (
  • Continuing review of the clinical trial conducted annually by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. (
  • 1 We suggest a scoring system for pooling this evidence and detail how this may be combined with hypothetical scenarios to assist in the design of, and justification for, a small randomised controlled trial. (
  • Once a clinical study is completed, the clinical study records are the primary - and often the only - evidence of clinical study activities, which are critical to permitting evaluation of the conduct of the study and the quality of the data produced. (
  • Serving over 2,000 healthcare organizations, Elsevier's clinical and technology experts are at the forefront of helping their customers leverage evidence-based content in the EMR and at the point of care. (
  • When implementing a trial, try if you can to leave a clear audit trail of who had access to what evidence at which point in the trial. (
  • Timely topics in statistical methods for clinical trials. (
  • To ask other readers questions about Key Statistical Concepts in Clinical Trials for Pharma , please sign up . (
  • An overview of commonly used statistical methods in clinical research. (
  • Bumps and bridges on the road to responsible sharing of clinical trial data. (
  • The Alliance works with partner organizations and government agencies such as FDA and NIH to increase older adult participation in clinical trials, including for diseases such as Alzheimer's disease. (
  • Clinical and Laboratory Features of Pertussis During a California Epidemic. (
  • citation needed] Consequently, laboratory and clinical trials testing this class of products as microbicides have largely been discontinued. (
  • The primary users of in silico clinical trials technologies will be the biomedical industries", explains Dr. McCormack. (
  • Advancing healthcare policy : Transparent, independent health authorities, Clinical trials regulation: choose transparency! (
  • FDA scientists have unique insights into this problem and unique abilities to do something about it, in doing so both improving clinical care and promoting more prudent use of healthcare resources. (
  • This will reduce the costs and the risks (both clinical and financial) involved in trials, and it will ultimately increase the rate of innovation in healthcare. (
  • A South Dakota rural healthcare provider will launch a clinical trial of anti-malarial drug hydroxychloroquine to see if it can cure or treat COVID-19, Republican Gov. Kristi Noem announced Monday. (
  • The biotech medicine is the first plant-produced antibody to be greenlit for clinical testing by Britain's Medicines and Healthcare products Agency . (
  • Inovio Pharmaceuticals, Inc. INO, +2.06% announced today that the company has initiated a phase I trial to evaluate safety, tolerability and immune responses of Inovio's DNA immunotherapy for Ebola. (
  • This initial trial will evaluate Inovio's Ebola immunotherapy (INO-4212) in five groups of healthy subjects receiving INO-4212 and its components (INO-4201 and INO-4202) alone or in combination with INO-9012, delivered into muscle or skin using Inovio's proprietary DNA delivery technology. (
  • Clinical trials compare the effectiveness of this medicine or treatment against standard, accepted treatment or against a placebo if there is no standard treatment. (
  • Complexities in sample handling, instrument setup and data analysis are barriers to the effective use of flow cytometry to monitor immunological parameters in clinical trials. (
  • Access to patient-level data from GlaxoSmithKline clinical trials. (
  • The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. (
  • The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial. (
  • Numerous recent drug disasters would have been avoided if public access to clinical data had been granted. (
  • The scientific data generated in clinical trials data are a public good. (
  • He is an advocate for greater public access to clinical trial data. (
  • eight trials provided individual patient data. (
  • Blinded and non-blinded assessors agreed in a median of 78% of assessments (interquartile range 64-90%) in the 12 trials with available data. (
  • Person who handles the administrative and day-to-day responsibilities of a clinical trial, acts as liaison for the clinical site, and reviews all data and records before a monitor's visit. (
  • Each site employs a qualified obstetrician/gynecologist (for female-focused sites) or andrologist/urologist (for male-focused sites), study coordinator, and data/research manager, and has access to clinical facilities capable of recruiting for and conducting Phase I, II, and III clinical trials. (
  • Usually, these data are collected only at trial registration. (
  • Síle Lane from Sense About Science discusses the recent European Court injunction on clinical trial data. (
  • Management of data in clinical trials / Eleanor McFadden. (
  • For example, clinical-trial data from Schering-Plough indicated that patients taking its allergy drug Claritin showed a 46-percent improvement in symptoms. (
  • Reproducibility is a rarely discussed, but absolutely critical aspect of trial implementation and data management. (
  • hence reducing the accrual time for launching a human clinical trial. (
  • Research on the reasons for clinical trials' low accrual rates has identified several key barriers, which include a low rate of physicians' referral [ 7 , 8 ]. (
  • How to Conduct Clinical Trials in Children: A Tutorial. (
  • CCTN was established in 1996 to support research on male and female contraception and to conduct clinical trials of new contraceptive drugs and devices. (
  • This Frontiers in Oncology Research Topic provides futuristic perspectives with respect to the emerging requirements of large animal cancer models to address unmet clinical needs. (
  • Ginny Barbour, Medicine Editorial Director at PLOS, discusses a recently-published UK Government spending report on access to clinical trial information and the stockpiling of Tamiflu. (
  • Randomised controlled trials are regarded as the standard when comparing a new treatment with the standard treatment for a particular cancer. (
  • If you have cancer, a clinical trial may be an option for you. (
  • Trials are available for many cancers and all stages of cancer, not just advanced cancer. (
  • What is a Clinical Trial for Cancer? (
  • You can find clinical trials listed on the website of the National Cancer Institute (NCI) -- . (
  • Ask if there is a trial in your area related to your cancer. (
  • If participating in a thyroid cancer clinical trial is a good option for you, we can help you find the research study that best fits your needs. (
  • Learn about thyroid cancer clinical trials enrolling patients now. (
  • Scientists look for new ways to treat advanced breast cancer in clinical trials. (
  • Through a clinical trial, a patient may get access to a new medicine that could potentially be the next great drug," says Erica L. Mayer, MD, MPH, of the Dana-Farber Cancer Institute in Boston. (
  • Community cancer clinics near you may be part of a large trial. (
  • Clinical trials are an extremely important in finding new ways to treat cancer and help patients live well with their diagnosis. (
  • On this episode of Frankly Speaking Cancer, host Kim Thiboldeaux is joined by four guests with four different clinical trial experiences who will each share their stories of how participating in a clinical trial gave them each hope. (
  • Some patients are reluctant to take part in clinical trials for fear of getting no treatment at all for their brain cancer. (
  • This website lists more than 12,000 cancer clinical trials, describes the trials, gives eligibility criteria, and explains what to do when you find one that you think is right for you. (
  • This website offers up-to-date information for locating federally and privately supported clinical trials for cancer in the U.S. and around the world. (
  • Sutter Health patient Bob Murphy describes how a clinical trial helped change his life while battling lung cancer. (
  • Sutter Health patient Laura Clausen describes how research and clinical trials at Sutter gave new hope in her cancer journey. (
  • Patient Grace Mansell describes how clinical research and clinical trials at Sutter are helping advance treatment options for cancer patients. (
  • Medical clinical trials are about more than just testing medications, they provide valuable research that can lead to better treatment methods for beating cancer. (
  • This topic will tell you about the early testing, diagnosis, and treatment of colorectal cancer. (
  • If you want to learn about colorectal cancer that has come back or has spread, see the topic Colorectal Cancer, Metastatic or Recurrent . (
  • If you want to learn about anal cancer, see the topic Anal Cancer . (
  • Therefore, the clinical use of fenretinide as a cancer therapeutic by itself is limited-that is, unless delivered to cancer cells in a manner via which the molecule's insolubility will no longer be problematic. (
  • Please find clinical trials at HSS listed by the following topics or view the full directory . (
  • I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the website. (
  • Find out more about our research by topic below. (
  • Find out more about some of the clinical trials we support. (
  • Learn about why you might want to enroll in a clinical trial and where to find one. (
  • How to Find a Clinical Trial? (
  • The purpose of a clinical trial is to find out whether a medicine or treatment is safe and effective for treating a certain condition or disease. (
  • Your doctor will help you find out if you are eligible to take part in a clinical trial. (
  • The only way to find out which treatment is best is by comparing them head-to-head in a clinical trial. (
  • The following websites offer information and services to help you find a clinical trial that is right for you. (
  • For all the science behind today's drugs, it's often a trial-and-error process to find the ones that work best for you . (
  • Non-orthopedic and non-rheumatologic clinical trials are conducted at Weill Cornell Medical College , an affiliate of Hospital for Special Surgery. (
  • Clinical Trials, Phase II as Topic" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus, MeSH (Medical Subject Headings) . (
  • Clinical Trials as Topic" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus, MeSH (Medical Subject Headings) . (
  • A medical researcher in charge of carrying out a clinical trial's protocol. (
  • Clinical trials play a significant role in medical research and, without them, innovative discoveries and breakthroughs wouldn't make it to the patients who need them. (
  • In a news item reported in Rolling Stone , NPR , and The Houston Chronicle , the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own "observational" trials-minus a control group, minus informed consent, minus informing anyone. (
  • We started adjusting it based on the needs of the medical community for acknowledgment, for having a clinical as well as a plain English page. (
  • Phase I clinical trials for its safety are expected to begin later this year at the Rush University Medical Center in Chicago. (
  • All collapsed athletes admitted to the medical facilities were considered for the trial. (
  • Economic return of clinical trials performed under the pediatric exclusivity program. (
  • PURPOSE: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit, and the ethical concerns of pediatric hematologists and oncologists in the United Kingdom and North America. (
  • A major objective of this funding opportunity announcement (FOA) is to invite SBIR applications to foster collaboration between clinical and bioengineering research communities to develop and test safe, accurate, and effective devices for use in neonatal, perinatal, and pediatric care settings. (
  • Dedicated to clinical excellence, Dr Arrieta is board certified in pediatrics and pediatric infectious diseases. (
  • Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study. (
  • Moreover, the European Ombudsman's ruling is that clinical study reports contain no "commercially confidential" information (2,7). (
  • Since 2009, Dr. Doshi has worked with a team that sifted through FDA approval packages and formerly confidential clinical study reports of the anti-influenza drugs oseltamivir and zanamivir. (
  • The type of study used for most clinical trials is called a randomized, controlled clinical trial . (
  • Who can be part of a clinical trial depends on the study. (
  • In a multi-site study, the coordinator at the CCC oversees the clinical research coordinators at the clinical sites and is called the Project Coordinator. (
  • Clinical trials are also monitored during the entire study. (
  • Before you join a clinical trial, you will learn about the safety guidelines, what is expected of you, and how long the study will last. (
  • Each clinical study has guidelines about who can join. (
  • well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections. (
  • For example, a treatment recommendation that involves the possibility of enrolling in a clinical trial is fraught with uncertainty because patients are generally randomized into one of multiple treatment arms, and because the treatment itself is under study [ 13 ]. (
  • SMi's Clinical Trial Documentation masterclass returns to London in 2016! (
  • SMi is proud to announce the return of the 2nd annual Clinical Trial Documentation Management masterclass in 2016! (
  • The phase I trial, carried out at the University of Surrey Clinical Research Centre , will test the safety of the plant-produced antibody designed to stop transmission of HIV when applied directly to the vaginal cavity. (
  • Becoming a successful clinical trial investigator : a step by step guide for developing a clinical trial site / P.K. Julka. (
  • Even with a successful clinical trial, there are still limitations on what advertising can say or imply. (
  • Dr. Ajai Chari will be discussing the importance of clinical trials and why people should enrol in them. (
  • The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing research on current topics in Alzheimer's disease and its related dementias. (
  • Memorial Sloan Kettering doctors are constantly working to improve treatment for people with soft tissue sarcoma through clinical trials. (