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 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.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.
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.
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.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
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.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
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.
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.
Substances that inhibit or prevent the proliferation of NEOPLASMS.
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.
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.
The relationship between the dose of an administered drug and the response of the organism to the drug.
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.
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.
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.
Elements of limited time intervals, contributing to particular results or situations.
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.
The giving of drugs, chemicals, or other substances by mouth.
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.
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.
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.
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.
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.
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.
A genus of gram-negative, rod-shaped bacteria that is widely distributed in TICKS and various mammals throughout the world. Infection with this genus is particularly prevalent in CATTLE; SHEEP; and GOATS.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
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)
A statistical means of summarizing information from a series of measurements on one individual. It is frequently used in clinical pharmacology where the AUC from serum levels can be interpreted as the total uptake of whatever has been administered. As a plot of the concentration of a drug against time, after a single dose of medicine, producing a standard shape curve, it is a means of comparing the bioavailability of the same drug made by different companies. (From Winslade, Dictionary of Clinical Research, 1992)
Functionalization of exogenous substances to prepare them for conjugation in PHASE II DETOXIFICATION. Phase I enzymes include CYTOCHROME P450 enzymes and some OXIDOREDUCTASES. Excess induction of phase I over phase II detoxification leads to higher levels of FREE RADICALS that can induce CANCER and other cell damage. Induction or antagonism of phase I detoxication is the basis of a number of DRUG INTERACTIONS.
Earlier than planned termination of clinical trials.
Therapy with two or more separate preparations given for a combined effect.
An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.
A publication issued at stated, more or less regular, intervals.
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.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
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)
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.
A decrease in the number of NEUTROPHILS found in the blood.
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.
Antibodies produced by a single clone of cells.
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.
Tumors or cancer of the LUNG.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
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.
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.
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.
Tumors or cancer of the human BREAST.
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.
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.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
An alkaloid isolated from the stem wood of the Chinese tree, Camptotheca acuminata. This compound selectively inhibits the nuclear enzyme DNA TOPOISOMERASES, TYPE I. Several semisynthetic analogs of camptothecin have demonstrated antitumor activity.
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).
The teaching or training of patients concerning their own health needs.
The return of a sign, symptom, or disease after a remission.
Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity.
A subnormal level of BLOOD PLATELETS.
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.
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.
Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
A subspecialty of internal medicine concerned with the study of neoplasms.
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.
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 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.
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.
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
The forcible expulsion of the contents of the STOMACH through the MOUTH.
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)
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.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
A 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.
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
A group of diterpenoid CYCLODECANES named for the taxanes that were discovered in the TAXUS tree. The action on MICROTUBULES has made some of them useful as ANTINEOPLASTIC AGENTS.
Patient involvement in the decision-making process in matters pertaining to health.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
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.
Voluntary cooperation of the patient in following a prescribed regimen.
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.
Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
Financial support of research activities.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Volume of biological fluid completely cleared of drug metabolites as measured in unit time. Elimination occurs as a result of metabolic processes in the kidney, liver, saliva, sweat, intestine, heart, brain, or other site.
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
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.
Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)
The 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.
The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.
An organoplatinum compound that possesses antineoplastic activity.
An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
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.
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.
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.
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.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
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.
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.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
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.
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
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.
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)
Antimetabolites that are useful in cancer chemotherapy.
Agents and endogenous substances that antagonize or inhibit the development of new blood vessels.
"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.
Injections made into a vein for therapeutic or experimental purposes.
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.
Disorders of the blood and blood forming tissues.
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.
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)
Proteins prepared by recombinant DNA technology.
Disease having a short and relatively severe course.
INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.
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.
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.
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.
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)
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.
Agents that inhibit PROTEIN KINASES.
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.
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity.
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.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
Organic compounds which contain platinum as an integral part of the molecule.
Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.
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.
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 antineoplastic agent. It has significant activity against melanomas. (from Martindale, The Extra Pharmacopoeia, 31st ed, p564)
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
Therapeutic act or process that initiates a response to a complete or partial remission level.
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.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Use of plants or herbs to treat diseases or to alleviate pain.
Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS.
Compounds with a six membered aromatic ring containing NITROGEN. The saturated version is PIPERIDINES.
The use of humans as investigational subjects.
Those individuals engaged in research.
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.
Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.
Compounds that include the amino-N-phenylamide structure.
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.
Azoles of one NITROGEN and two double bonds that have aromatic chemical properties.
An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.
Resistance or diminished response of a neoplasm to an antineoplastic agent in humans, animals, or cell or tissue cultures.
An acute infectious disease caused by COXIELLA BURNETII. It is characterized by a sudden onset of FEVER; HEADACHE; malaise; and weakness. In humans, it is commonly contracted by inhalation of infected dusts derived from infected domestic animals (ANIMALS, DOMESTIC).
Tumors or cancer of the PROSTATE.
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.
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)
Organic salts and esters of benzenesulfonic acid.
Radiotherapy where cytotoxic radionuclides are linked to antibodies in order to deliver toxins directly to tumor targets. Therapy with targeted radiation rather than antibody-targeted toxins (IMMUNOTOXINS) has the advantage that adjacent tumor cells, which lack the appropriate antigenic determinants, can be destroyed by radiation cross-fire. Radioimmunotherapy is sometimes called targeted radiotherapy, but this latter term can also refer to radionuclides linked to non-immune molecules (see RADIOTHERAPY).
Societies whose membership is limited to physicians.
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.
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.
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.
A family of 6-membered heterocyclic compounds occurring in nature in a wide variety of forms. They include several nucleic acid constituents (CYTOSINE; THYMINE; and URACIL) and form the basic structure of the barbiturates.
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.
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 which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers.
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).
A malignant epithelial tumor with a glandular organization.
Antitumor alkaloid isolated from Vinca rosea. (Merck, 11th ed.)
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)
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.
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.
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.
A class of drugs that differs from other alkylating agents used clinically in that they are monofunctional and thus unable to cross-link cellular macromolecules. Among their common properties are a requirement for metabolic activation to intermediates with antitumor efficacy and the presence in their chemical structures of N-methyl groups, that after metabolism, can covalently modify cellular DNA. The precise mechanisms by which each of these drugs acts to kill tumor cells are not completely understood. (From AMA, Drug Evaluations Annual, 1994, p2026)
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.
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.
Forceful administration into a muscle of liquid medication, nutrient, or other fluid through a hollow needle piercing the muscle and any tissue covering it.
Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin.
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)
An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
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.
A group of compounds that contain the structure SO2NH2.
A compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
An infant during the first month after birth.
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.
A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.
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.
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 semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

Advances in the biological therapy and gene therapy of malignant disease. (1/620)

Biological and gene therapy of cancer have become important components of clinical cancer research. Advances in this area are based on evidence for the presence of tumor antigens, antitumor immune responses, evasion of host control by tumors, and the recognition of host defense failure in cancer patients. These mechanisms are being corrected or exploited in the development of biological and gene therapy. Over the last decade, 9 biological therapies have received Food and Drug Administration approval, and another 12 appear promising and will likely be approved in the next few years. Our approach to gene therapy has been to allogenize tumors by the direct intratumoral injection of HLA-B7/beta2-microglobulin genes as plasmid DNA in a cationic lipid into patients with malignant melanoma. In four Phase I studies, we found a 36% response by the local injected tumor and a 19% systemic antitumor response. In other cancers, gene transfer, expression, and an intratumoral T-cell response were seen, but no clinical response was seen. A variety of follow-up studies with HLA-B7 and other genes are planned. Evasion of host control is now a major target of gene therapy. Strategies to overcome this include up-regulation of MHC and introduction of cell adhesion molecules into tumor cells, suppression of transforming growth factor and interleukin 10 production by tumor cells, and blockade of the fas ligand-fas interaction between tumor cells and attacking lymphocytes. With these approaches, it seems likely that gene therapy may become the fifth major modality of cancer treatment in the next decade.  (+info)

Epidermal growth factor receptor inhibition by a monoclonal antibody as anticancer therapy. (2/620)

Monoclonal antibody (mAb) 225 against the human epidermal growth factor receptor blocks activation of receptor tyrosine kinase. This retards or arrests cell cycle progression, with accumulation of cells in G1 phase. The mechanism of growth inhibition involves increased levels of p27KIP1 and inhibition of cyclin-dependent kinase-2 activity. mAb in combination with chemotherapy exhibits a synergistic antitumor activity, with successful eradication of well-established tumor xenografts that resist treatment with either mAb or drug alone. A Phase I clinical trial has established the safety of repeated administration of human:mouse chimeric mAb 225 at concentrations that maintain receptor-saturating blood levels for up to 3 months. Phase I trials exploring mAb 225 treatment in combination with doxorubicin, cisplatin, or paclitaxel are ongoing.  (+info)

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. (3/620)

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.  (+info)

Development of difluoromethylornithine (DFMO) as a chemoprevention agent. (4/620)

D,L-alpha-difluoromethylornithine (DFMO) was synthesized over 20 years ago. It was hoped that this enzyme-activated, irreversible inhibitor of ornithine decarboxylase, the first enzyme in polyamine synthesis, would be effective as a chemotherapy for hyperproliferative diseases, including cancer and/or infectious processes. DFMO was generally found to exert cytostatic effects on mammalian cells and tissues, and its effectiveness as a therapeutic agent has been modest. DFMO was also found to cause treatment-limiting (but reversible) ototoxicity at high doses. This side effect, along with its minimal therapeutic activity, contributed to the loss of interest by many clinicians in further developing DFMO as a cancer therapeutic agent. However, DFMO was subsequently shown to inhibit carcinogen-induced cancer development in a number of rodent models, and interest in developing this compound as a preventive agent has increased. The rationale for the inhibition of ornithine decarboxylase as a cancer chemopreventive agent has been strengthened in recent years because this enzyme has been shown to be transactivated by the c-myc oncogene in certain cell/tissue types and to cooperate with the ras oncogene in malignant transformation of epithelial tissues. Recent clinical cancer chemoprevention trials, using dose de-escalation designs, indicate that DFMO can be given over long periods of time at low doses that suppress polyamine contents in gastrointestinal and other epithelial tissues but cause no detectable hearing loss or other side effects. Current clinical chemoprevention trials are investigating the efficacy of DFMO to suppress surrogate end point biomarkers (e.g., colon polyp recurrence) of carcinogenesis in patient populations at elevated risk for the development of specific epithelial cancers, including colon, esophageal, breast, cutaneous, and prostate malignancies.  (+info)

Predictive value of preclinical toxicology studies for platinum anticancer drugs. (5/620)

Rodent and nonrodent toxicology studies are currently expected to support Phase I trials of antineoplastic drugs in the United States. To determine the predictive value of these studies, we initiated a project to compare preclinical and clinical toxicity data within various drug classes. The first class analyzed was the platinum anticancer drugs. Twelve platinum analogues that had both preclinical (mice, rats and/or dogs) and clinical data from matching drug administration schedules were identified. The rodent LD10 (the dose that causes lethality in 10% of treated animals) or dog toxic dose high (a dose that when doubled causes lethality in dogs) correlated well with the human maximally tolerated dose on a mg/m2 basis. For every platinum analogue investigated, one-third the rodent LD10 or one-third the dog toxic dose high in mg/m2 gave a starting dose and a first escalation dose that did not exceed the clinical maximally tolerated dose. The dose-limiting toxicities in patients were previously observed in 7 of 7, 7 of 8, and 9 of 11 mouse, rat, and dog studies, respectively. Our data indicate that mice, rats, and dogs all had value in predicting a safe starting dose and the qualitative toxicities in humans for platinum anticancer compounds. The efficiency of Phase 1 trials could have been improved without sacrificing patient safety by allowing higher starting doses for this drug class than conventionally permitted.  (+info)

Preclinical and early clinical development of keratinocyte growth factor, an epithelial-specific tissue growth factor. (6/620)

Keratinocyte growth factor (KGF) is a 28-kDa heparin-binding member of the fibroblast growth factor (FGF) family (alternative designation = FGF-7) that specifically binds to the KGF receptor, a splice variant of FGF receptor 2, which is expressed only in epithelial tissues. KGF has been identified as an important paracrine mediator of proliferation and differentiation in a wide variety of epithelial cells, including hepatocytes and gastrointestinal epithelial cells, type II pneumocytes, transitional urothelial cells, and keratinocytes in all stratified squamous epithelia. Systemic administration of recombinant human KGF (rHuKGF) provides significant cytoprotection to epithelial tissues in a number of different animal models of epithelial/mucosal damage, including models of injury to the gastrointestinal tract, lung, urinary bladder, and hair follicles. The results obtained with these preclinical models prompted an investigation of the use of rHuKGF as a cytoprotective agent against radiation- and/or chemotherapy-induced oral and gastrointestinal mucositis. Several dose- and time-variable studies were conducted in normal rhesus macaques to determine the lowest dose and shortest duration of rHuKGF administration required to induce oral mucosal proliferation without other significant systemic effects. Numerous studies were also conducted in murine models of chemotherapy-induced mucositis to fine-tune the dosing schedule. These studies showed that 2-3 days of rHuKGF administration were sufficient to induce significant oral mucosal proliferation and to protect against gastrointestinal mucositis when administered prior to the initiation of chemotherapy. The results from these models were used to design a phase I study in normal human volunteers to evaluate the safety of rHuKGF and its ability to induce oral mucosal proliferation. rHuKGF was well tolerated and induced a significant increase in markers of oral mucosal proliferation following 3 days of administration at the highest doses. Phase I/II studies to evaluate the safety and efficacy of rHuKGF in the prevention of chemotherapy-induced mucositis are currently in progress.  (+info)

Transaminase elevation on placebo during phase I trials: prevalence and significance. (7/620)

AIMS: To evaluate the prevalence of transaminase elevation on placebo during Phase I trials. METHODS: Retrospective review of pooled transaminase data collected on placebo during 13 Phase I trials in 93 healthy volunteers hospitalized for 14 days, with determination of the prevalence of abnormally high values. RESULTS: 20.4% of the 93 subjects showed at least one ALT value above the upper limit of the normal range (ULN), and 7.5% had at least one value twice ULN. CONCLUSIONS: Laboratory safety results of Phase I trials should be interpreted with caution, in the light of data on placebo, to avoid premature discontinuation of the development of safe drugs wrongly believed to be hepatotoxic.  (+info)

Ovarian cancer BRCA1 gene therapy: Phase I and II trial differences in immune response and vector stability. (8/620)

Gene therapy with viral vectors has shown some promise in nude mice models and in initial Phase I trials of patients with extensive metastatic cancer. A Phase I clinical trial (D. L. Tait et al., Clin. Cancer Res., 3: 1959-1968, 1997) of ovarian cancer patients treated with i.p. retroviral LXSN-BRCA1sv gene therapy reported stable vector, minimal antibody response, and tumor reduction. We initiated a Phase II trial on patients with less extensive disease to evaluate vector pharmacokinetics, immune response, toxicity, and efficacy. Patients received a surgically implanted peritoneal catheter to administer infusions of vector, as well as to retrieve daily samples of peritoneal fluid for analysis. Ovarian cancer patients received four daily i.p. injections of LXSN-BRCA1sv vector therapy for three cycles, 4 weeks apart. Patient peritoneal fluid and plasma were analyzed extensively by PCR, Western blot, complement level (CH50), and chemical and hematological tests. Phase II patients showed no response, no disease stabilization, and little or no vector stability. Because of vector instability and rapid antibody development, which differed dramatically from the Phase I trial data, the trial was terminated after treatment of six patients. Immune system status appears to have played a major role in whether gene therapy was effective. Comparison of Phase I and II patients showed significant differences in tumor burden, immune system status, and response to BRCA1 gene therapy.  (+info)

Vol 6: Informed Consent for Phase I Oncology Trials: Form, Substance and Signature.. . Biblioteca virtual para leer y descargar libros, documentos, trabajos y tesis universitarias en PDF. Material universiario, documentación y tareas realizadas por universitarios en nuestra biblioteca. Para descargar gratis y para leer online.
DescriptionThe main goal of a Phase I cancer clinical trial is to identify the maximum tolerated dose (MTD) of a new drug having acceptable dose-limiting toxicity (DLT). Two main model-based designs are continual reassessment method (CRM) (OQuigley et al., 1990) and escalation with overdose control (EWOC) (Babb et al., 1998). Most of the designs are based on the binary toxic outcome. The occurrence of DLT is assessed over a predefined time window, and complete follow-up of the current patient is required to fit the model. Information is lost by categorizing time to DLT to a binary variable and might lead to a poor estimate of MTD. Trials might have to suspend accrual to obtain complete data and lead to long trial durations and complicate administrative burdens. Some methods have been proposed to incorporate the time-to-DLT using a weight function, such as TITE-CRM by Cheung and Chappell (2000) and TITE-EWOC by Mauguen et al. (2011). A better approach would be to model the time-to-DLT data ...
The continual reassessment method (1) (CRM) for phase I cancer trials provides improved estimation of the maximum tolerated dose (MTD), and fewer patients receive ineffective dose levels compared to the traditionally used design. However, the CRM has not gained acceptance in practice owing to concer …
BACKGROUND: Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM). METHODS: We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation. RESULTS: We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources. The most prominent barriers to implementation of a model-based design were lack of suitable training, chief investigators preference for algorithm-based designs (e.g., 3+3), and limited resources for study design before funding. We use a real-world example to illustrate how these barriers can be overcome. CONCLUSIONS: There is overwhelming evidence for the benefits of CRM. Many leading pharmaceutical companies routinely implement model-based designs.
AstraZeneca Announces Progress on Global PARTHENON Clinical Trial Program with BRILINTA (ticagrelor) in High-Risk Cardiovascular Disease Patient Populations in Advance of American College of...
Cornerstone Pharmaceuticals gets Approval to Conduct Phase I/II Clinical Trial of CPI-613 in Cancer Patients by US FDA 25 th July 2008. Cornerstone Pharmaceuticals, Inc., a privately held pharmaceutical company, has received clearance from the US Food and Drug Administration (FDA) to begin a Phase I/II clinical trial evaluating the safety and early efficacy of its first-in-class Altered Energy Metabolism-Directed (AEMD) compound, CPI-613, in a variety of cancer types.. CPI-613 targets distinctive changes in the energy generating processes associated with the vast majority of solid tumor types, according to preclinical studies. CPI-613 has shown possible utility in multiple preclinical studies including studies conducted using human tumor biopsies from patients bearing lung, colon, pancreatic and breast tumors as well as cancer cell lines resistant to traditional chemotherapeutics.. The approved clinical trial will be open to patients with a variety of tumor types who have failed previous ...
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, this online resource for oncology trainees and specialists explains cancer drug development and includes information on Phase 0 Trials, immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase ...
TY - JOUR. T1 - Multidecadal Analysis of an Engineered River System Reveals Challenges for Model-Based Design of Human Interventions. AU - Berends, Koen D.. AU - Gensen, Matthijs R.A.. AU - Warmink, Jord J.. AU - Hulscher, Suzanne J.M.H.. PY - 2021. Y1 - 2021. N2 - Hydraulic models were used in practice to predict the effect of human intervention during extreme conditions. However, the accuracy of such predictions remains untested. In this study, we compare a simulated trend in water levels covering a twenty-year period of large-scale human intervention with a thirty-year observational record. The results show that the observed water levels display a linearly decreasing trend attributed to channel bed erosion. A deviation from this trend, which would be an indication of the effect of human intervention, was not observed. We propose that the most likely explanation for this is that any effect observable at lower discharge is hidden in the uncertainty of the rating curve. Given the inherent ...
Simulink is a block diagram environment for Model-Based Design. It supports simulation, automatic code generation, and continuous testing of embedded systems.
DelMar Pharmaceuticals Receives Approval from MD Anderson Cancer Centers IRB for Protocol Expansion. Vancouver, BC, April 10, 2019--DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI), a Vancouver-based biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced this week that the University of Texas MD Anderson Cancer Centers (MDACC) Institutional Review Board (IRB) has approved a trial protocol amendment to expand DelMars ongoing Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated glioblastoma (GBM).
IDX899 Demonstrates Rapid and Profound Inhibition of HIV Replication in a Phase I/II Clinical Trial in Treatment-Naive HIV-Infected Patients CAMBRIDGE, Mass., Feb. 6 -- Idenix Pharmaceuticals, Inc.
TxCell Presents Final Positive Results of the Phase I/II Clinical Trial With Antigen-Specific Treg Cells in Crohns Disease - read this article along with other careers information, tips and advice on BioSpace
RV 172: A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant ADENOVIRUS-5 Vector Vaccine, VRC-HIVADV014-00-VP in HIV Uninfected Adu 1/28/2010 Results from the RV172 study of a vaccine candidate in East Africa conducted by MHRP were published recently in
Basel, March 7, 2018 Novartis today announced an additional strategic alliance with Science 37, a leader in decentralized clinical trial technology and design, to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly site-less model. Novartis was an early investor in Science 37 and together we have already initiated virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH). Decentralized, or virtual, trials harness digital technology to allow some or all aspects of a clinical trial to be carried out at a participants home or local physicians office, rather than at a central trial site such as a large hospital. The new Novartis decentralized trials are expected to begin later this year in the United States (US) in the areas of dermatology, neuroscience and oncology, leveraging Science 37s proprietary Network Oriented Research Assistant ...
Sajay Popats interests include identification of DNA variants that influence thoracic tumour development, the identification of biomarkers,...
Emma Watson and Helena Bonham Carter wowed at Prince Williams charity dinner yesterday evening, both looking extremely beautiful. Emma looked chic in a white shirt and long grey skirt, while Helena wore a glamorous silk navy dress. Check out a couple of pictures from the event here.. ...
The care of patients with cancer has been a multidisciplinary effort throughout the 60-year history of MD Anderson Cancer Center. In the early years, cancer care at MD Anderson involved primarily the disciplines of diagnostic imaging, pathology, and a treatment modality. The complexity of these interrelationships has increased at a seemingly exponential rate, especially in the last decade. Technological advances, introduction of new drugs, improvements in supportive care, and exciting findings in basic and translational research have placed demands on the entire medical team for constant education and coordination.. Lung cancer is a leading cause of death from cancer throughout the world. It is by far the leading cause of death in all urbanized countries, and it has rapidly risen in importance in developing countries. An intensely committed group of physicians and laboratory investigators has been gathered at MD Anderson to treat lung cancer. Their understanding of the diseases involved and ...
Trial participants will receive intravitreal injections of APL-2, or a sham procedure (placebo), monthly or every other month. The injections are made into the vitreous, the soft gel in the middle of the eye.
Katherine: For people who dont understand how treatment approvals work, which would you give us an overview of the stages of clinical trials?. Dr. Mato: Sure. Im very involved in clinical trials at my center. There are different phases of clinical trials. And so, the way that I think about them would be - lets focus on Phase I through III, because those are probably the most relevant ones for patients. The purpose of a Phase I trial is really to define the dose of the drug and confirm that its safe or not. We get very, very preliminary data about activity of the drug, but the major question thats being asked is, Is this drug safe?. Phase II is - and I should also add that Phase I trials are relatively small. So, its a small number of patients where were trying to find the right dose. By the time we get to Phase II, we know the drug is likely safe. We have a lot of information about its side effect profile. We might have a hint that its active. And so, the purpose of a Phase II trial is ...
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Our experience demonstrates the feasibility of implementing this design in multi-institutional trials and the possibility of performing dose-finding studies that require fewer patients than conventional methods.
Promise is published four times a year by The University of Texas MD Anderson Cancer Center and is dedicated to our friends who have joined us in Making Cancer History®. The Summer 2016 issue features a spotlight on MD Andersons corporate giving program, photos from the Saks Fifth Avenue reopening benefiting MD Anderson and survivor stories and testimonials.
It is the policy of The University of Texas MD Anderson Cancer Center that the program chair(s), planning committee member, faculty/teacher/ author, or CME activity reviewer must disclose any relevant financial relationships with commercial interests whose products may be discussed in the activities, if any. MD Anderson also requires that faculty disclose any unlabeled use or investigational use (not yet approved for any purpose) of pharmaceutical and medical device products. Specific disclosure will be made to the participants prior to the educational activity. ...
Clinical trials are studies of new, innovative cancer treatments. Get basic information about clinical trials, and see what studies are being conducted at Baptist MD Anderson Cancer Center.
A new room for parents of sick children has been refurbished at the Royal Marsden hospital thanks to the friends and family of Lewis Houghton
The Rod Taylor Care Center at MD Anderson Cancer Center, Orlando specializes in multimodality treatment for diseases of the lung including mesothelioma cancer.
Michael Wang M.D. Professor of Medicine Department of Lymphoma/Myeloma MD Anderson Cancer Center Presenting Window Trial on Mantle Cell Lymphoma. Date: 3/29/17, 8am to ...
MD Anderson Cancer Center Acquires Two Elekta Versa HD Systems - read this article along with other careers information, tips and advice on BioSpace
In 2012, Community was the first healthcare system to join MD Anderson Cancer Network®, a program of The University of Texas MD Anderson Cancer Center, with two hospitals exclusively affiliated in Indiana. Today, all five Community hospitals that provide cancer care are certified members of MD Anderson.
OhioHealth announced today that OhioHealth OBleness Hospital has become a certified member of MD Anderson Cancer Network®, a program of MD Anderson Cancer Center, a world-renowned leader in cancer care.
uniQure plots to initiate a three-pronged clinical trial program next year as key assets from its in-house pipeline and Bristol-Myers Squibb collaboration advance. uniQure aims to move its hemophilia B gene therapy, AMT-060, into a pivotal trial while working to advance a Huntingtons disease asset and Bristol-Myers-partnered heart failure candidate into the clinic.
VANCOUVER, British Columbia, May 21, 2014-- Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced that recent advances in its clinical programs were presented at the 17 th Annual Meeting of the American Society of Gene and Cell Therapy, which is taking place in in Washington, DC, May 21 to 24..
Adenocarcinoma/complications/*diagnosis/mortality/*secondary,Adolescent,Adult,Aged,Aged, 80 and over,Brain Neoplasms/complications/*diagnosis/mortality/*secondary,Delirium/etiology,Headache/etiology,Humans,Incidence,Magnetic Resonance Imaging,Male,Middle Aged,Prognosis,Prostatic Neoplasms/*pathology,Retrospective Studies,Survival ...
From the moment you connect to the Respondent Portal, all information, including logins, responses and other information, are encrypted from the moment they leave your computer to the point at which it is received by the EEOC. EEOC uses a number of mechanisms and practices to ensure the integrity of this encryption. Older encryption standards are blocked, and those that are permitted are configured following industry best practices. Further, EEOC is responsive to identified weaknesses in encryption standards and make take immediate action pursuant to the National Institute of Standards and Technology (NIST), National Vulnerability Database (NVD) and vendor recommendations. EEOC recommends all users of the Respondent Portal use current, supported versions of their web browser to ensure confidentiality as well as compatibility with our encryption standards.. ...
Robust systems designed to enable the use of engineered molecular systems in biotechnological and medical applications are of particular interest. This project will address various aspects of methods and model development for Molecular Systems Engineering to enable rational (model-based) design of molecular systems and component features such as kinetic parameters in iterations with experimental (analysis) approaches. For the rational design of synthetic molecular systems, mathematical models of different types have been developed. While a growing number of computational design tools implements such formal approaches, major challenges remain, for example, in terms of systematic model development and in the rational design of informative experiments for systems characterization. In the area of model-based analysis and design of genetic circuits, the development of computational models and design methods will enable rational design of parts and circuits. Another focus on the design of engineered ...
B&R Industrial Automation used MATLAB and Simulink to model virtual sensors and design a controller that uses the sensors to optimize performance.
ITK Engineering modeled controller software, ran closed-loop simulations, generated production code, and streamlined unit testing for the BLDC motor.
François Chapuis and colleagues examine a cohort of clinical trial protocols approved by French ethics committees, and show that Phase I trials are less frequently published than other types of trials.
François Chapuis and colleagues examine a cohort of clinical trial protocols approved by French ethics committees, and show that Phase I trials are less frequently published than other types of trials.
My first sabbatical was in England at the Chester Beatty Research Institute, (Royal Marsden Hospital) in Sutton a suburb south of London. The year was 1973. I remember this year very clearly since we were in England during the Yom Kippur war and also during the great English (Welsh) coal strike. The Royal Marsden was an institute famous for studies of leukemia, and was affiliated with the Chester Beatty Hospital in the city. I had chosen to work there because of Dr. Peter Alexander and his publications on macrophage activity and response to double stranded (ds) RNA. Macrophages are cells of the immune system that eat and clean up the body of foreign material and bacteria, and even destroy virus-infected cells. We had been working in my laboratory with a virus that during its replication produced large amounts of double stranded RNA, although the virus itself is single stranded. Double stranded RNA treatment of macrophages led to what were called angry macrophages. Microscopically the cells ...
In my posting in July I mentioned that I had asked my wonderful consultant about referring me to The Royal Marsden hospitals sarcoma team for my follow up surveillance. At 2pm today I had my first consultation appointment with the sarcoma team at The Royal Marsden. The waiting room was absolutely packed and I waited…
ROCKVILLE, Md., March 15, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) today provided an update on its clinical trial programs and reported its 2012 financial results for the year ended December 31, 2012.. (Logo: 2012 saw the company achieve success in all of its Phase I clinical trial objectives, said Karl Johe, Ph.D., Neuralstems Chairman of the Board and Chief Scientific Officer. We have been able to demonstrate the safety and tolerability of Neuralstems novel core technologies, from intraspinal transplantation procedures, to the cells themselves in ALS patients, as well as our NSI-189 neurogenic small molecule drug in healthy volunteers. Additionally, we believe we have seen evidence of a treatment effect in some NSI-566 cell therapy patients over a sustained period of time, as measured by levels of functional recovery and a slowdown in the progression of ALS. In spinal cord injury, a leading peer-reviewed scientific ...
In the Phase I cohort, two patients stopped during Cycle I due to disease progression, and one was removed in cycle 4 due to noncompliance. In the Phase II cohort, one patient opted out after 1 cycle because of toxicity ...
The issue of transparency in clinical research has raised its head again with a new study suggesting the results of Phase I trials are less likely to be published compared to other types of studies.
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The Forum marked the first event to be held under the Groups recently established collaboration with the Department of Leukemia at the University of Texas MD Anderson Cancer Center, a world-renowned center dedicated to quality patient care, innovative research and the development of more effective treatments for all types of leukemia. The two-day educational forum, which aimed to provide blood cancer specialists with cutting-edge knowledge in their fields, gathered physicians from across the Middle East and North Africa (MENA), drawing an audience of more than 100 medical doctors from Jordan, Lebanon, Syria, Iraq, Palestine, Saudi Arabia, Kuwait, UAE, Egypt, Sudan and Tunisia. Throughout the Forum, distinguished speakers and experts from the Department of Leukemia at the MD Anderson Cancer Center, as well as representatives from other leading institutions, gave presentations on the state-of-the-art treatments utilized in the management of blood cancers. During a Meet the Experts session, ...
Phase I trials aim to identify the recommended dose for further development. Health-related quality of life (HRQoL) could be a complement to the usual National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale to detect adverse events and define the doses. The objective of this study is to review the phase I in oncology which used HRQoL as endpoint. A search in PubMed database identified phase I trials in oncology with HRQoL as endpoint, published between January 2012 to May 2016. Hematological and pediatric phase I were excluded. A total of 1333 phase I were identified and 15 trials were identified with HRQoL as endpoint (1.1%). The European Organisation for Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was the most frequently used instrument: 5 studies (33.3%). The targeted dimensions of HRQoL and the minimal clinically important difference were prespecified in 1 study (6.7%) and 2 studies (13.3%), respectively. Twelve studies (80%) described the
Aeroquin (MP-376) is delivered via an Investigational eFlow Nebulizer System, an inhalation delivery device optimized specifically for Aeroquin. The Investigational eFlow Nebulizer System uses eFlow® Technology to enable highly efficient aerosolization of medication via a vibrating, perforated membrane that includes thousands of small holes to produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size (it fits in the palm of the patients hand), light weight and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized ...
of preclinical data from research led by The University of Texas MD Anderson Cancer Center demonstrating that CG806, a highly potent pan-FLT3/pan-BTK inhibitor, exerts a ... ...
Ionis Pharmaceuticals and University of Texas MD Anderson Cancer Center are developing cancer therapeutics, utilising Ionis proprietary Antisense technology
The team at UT Health San Antonio MD Anderson Cancer Center specialize in multiple myeloma, which can affect men and women who are age 60 or older.
Research Assistant II - Epigenetics and Molecular Carcinogenesis in Healthcare/Hospital, Life Sciences with University of Texas MD Anderson Cancer Center. Apply Today.
Staff Scientist - Epidemiology in Healthcare/Hospital, Life Sciences with University of Texas MD Anderson Cancer Center. Apply Today.
Nurieva Roza Insafetdinovna from University of Texas MD Anderson Cancer Center, USA is a speaker at Immunology Summit-2015 conference
Simulation has played an important role in reducing design time and improving the reliability of power electronics systems. Over the years power electronics system diversity and complexity has grown to include subsystems which traditionally have used different modeling and simulation strategies, making the simulation of such systems difficult. This paper presents a standard simulation methodology for such complex power electronics systems based on cosimulation. This approach allows individual subsystems to be conveniently modeled in the most natural and trusted simulation environment. A simulation example of a four-phase buck converter employing digital control is provided. The power stage is modeled in Saber, and the digital controller is modeled in Simulnk using the Xilinx System Generator Blockset. The Saber-Simulink cosimulation is used as the interface between the two engines. Xilinx System Generator is used to automatically generate synthesizable code for Xilinx FPGAs. ...
Dr. Razelle Kurzrock joined University of California San Diego Moores Cancer Center in November 2012 as Senior Deputy Center Director for Clinical Science. She is also the Murray Professor of Medicine, Director of the Clinical Trials Office and, on July 1, 2014, became the Chief of the Division of Hematology-Oncology Division (in the UC San Diego School of Medicine) . Dr. Kurzrocks charge includes growing and innovating the clinical trials program, and heading the newly established Center for Personalized Cancer Therapy and the UCSD Moores Cancer Center Clinical Trials Office. Dr. Kurzrock is best known for successfully creating and chairing the largest Phase I clinical trials department in the world while at the University of Texas M.D. Anderson Cancer Center. Dr. Kurzrocks unique approach emphasizes using cutting-edge molecular profiling technologies to match patients with novel targeted therapies, reflecting a personalized strategy to optimize cancer treatment. Dr. Kurzrock has served as ...
Cancer Biology and Genetics Program, Memorial Sloan-Kettering Cancer Center, New York, New York, USA (R.L.B.); Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA (Q.W., R.G.V.); Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA (Q.W.); Department of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA (Q.W., R.G.V.); Bioinformatics unit, Structural Biology and Biocomputing Programme, Centro Nacional de Investigaciones Oncológicas, CNIO, Madrid, Spain (A.C.); Department of Computational Biology, The Jackson Laboratory, Farmington, Connecticut, USA (R.G.V.); Seve Ballesteros Foundation Brain Tumor Group, Cancer Cell Biology Programme, Centro Nacional de Investigaciones Oncológicas, CNIO, Madrid, Spain (M.S ...
Brain Tumor Center and Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.Department of Molecular and Cellular Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.Cancer Biology Program, MD Anderson Cancer Center UT Health Graduate School of Biomedical Sciences, The University of Texas, Houston, Texas. ...
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 ...
The Oncology Clinical Trials Program enables patients to access a wide spectrum of newly advanced treatments including immunotherapeutic drugs and targeted therapies for a range of solid and haematological malignancies.. Established in 2003 and led by Associate Professor Gary Richardson OAM, the Department aims to provide compassionate, state-of-the-art care for cancer patients and continued advancements in the prevention, diagnosis, treatment and cure of cancer via a combination of research, education and clinical practice.. How can you participiate in a clinical trial at Cabrini. The Szalmuk Family Department of Medical Oncology currently has more than 100 active clinical trials covering many different cancer streams. If you are interested in participating in a trial, please speak to your treating oncologist first. Your oncologist will provide you with general information on clinical trials and also discuss programs that may be relevant to you.. All patients with private health insurance can ...
Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential
This study assessed the tolerability and efficacy of vorinostat + fluorouracil + folinic acid in patients with metastatic fluorouracil-refractory colorectal
A total of 96 patients randomized in France and Switzerland. Results expected in Q1 2019. Lausanne, Switzerland - June 15, 2017 - Debiopharm Internati...
... Commences Phase I Clinical Trial of Proprietary siRNA Molecule in Ac... Renal Failure ...FREMONT Calif. Nov. 19 /- Quark Pharmaceuticals Inc. ...The Phase I clinical trial is a multi-center double-blind placeboco...,Quark,Pharmaceuticals,,Inc.,Announces,First,Systemic,siRNA,Dosing,in,Humans,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
A new program launched by the Institute of Cancer Research in the UK and the Royal Marsden NHS Foundation Trust, a London-based cancer center, aims to bring cancer predisposition gene testing to all cancer patients in the UK.
​Lung cancer includes non-small cell, small cell, mesothelioma, thymoma and neuroendocrine tumours. The Royal Marsden offers a full range of lung cancer treatments and care services.
Sanofi and GlaxoSmithKline have begun enrolling participants into a Phase III clinical study of their adjuvanted recombinant-protein Covid-19 vaccine candidate. The global randomised, double-blinded, placebo-controlled study will include about 35,000 volunteers aged 18 years and older from different countries, including sites in Asia, Africa, the US and Latin America. The study will assess vaccine formulations targeting the original D.614 virus and the B.1.351 variant across geographies. A booster trial is likely to begin in the coming weeks, with the vaccine expected to be approved by the end of 2021.. Novartis and Switzerland-based biopharma Molecular Partners have commenced the EMPATHY clinical trial, a Phase II and III study exploring the use of its DARPin therapeutic candidate ensovibep (MP0420) for treating Covid-19. Novartis is expected to conduct the clinical trial programme, with Molecular Partners as sponsor of the trials. Molecular Partners reported positive results from its initial ...
Coronavirus (COVID-19) latest: Visiting The Royal Marsden is still suspended, but we want to reassure our patients, their families and anyone worried about cancer during this difficult time that we are still delivering treatment - the hospital is open. Please see more information here about how we are keeping everyone safe.. ...
The event was organised and led by Dr Dima El-Sharkawi, a Consultant Haematologist at The Royal Marsden, and provided an excellent opportunity to find out more about hairy cell leukaemia (HCL), the latest treatment options and advice on nutrition and coping with the emotional impact of living with the condition.
ISI Document Delivery No.: FI8TE Times Cited: 0 Cited Reference Count: 17 Johnson, David C. Lenive, Oleg Mitchell, Jonathan Jackson, Graham Owen, Roger Drayson, Mark Cook, Gordon Jones, John R. Pawlyn, Charlotte Davies, Faith E. Walker, Brian A. Wardell, Christopher Gregory, Walter M. Cairns, David Morgan, Gareth J. Houlston, Richard S. Kaiser, Martin F. Myeloma UK as well as Cancer Research UK CTAAC sample collection grants [C2470/A12136, C2470/A17761]; Cancer Research UK Biomarkers and Imaging Discovery and Development grant [C2470/A14261]; Bloodwise; National Institutes of Health Biomedical Research Centre at the Royal Marsden Hospital This work was supported by Myeloma UK as well as Cancer Research UK CTAAC sample collection grants (C2470/A12136 and C2470/A17761) and a Cancer Research UK Biomarkers and Imaging Discovery and Development grant (C2470/A14261). Additional funding was provided by Bloodwise. This work was also supported by the National Institutes of Health Biomedical Research ...
The UK has the lowest survival rates for five of seven key cancers among some of the worlds richest nations.. Although survival rates are improving, the UK came bottom of the table for bowel, lung, pancreatic, stomach and rectal cancer.. Cancer Research UK analysed 3.9 million cancer cases between 1995 and 2014 in seven comparable high-income countries with universal healthcare (Australia, Canada, Denmark, Ireland, New Zealand, Norway and the UK).. Only for oesophagus and ovary cancer did UK do better than some of the other countries.. The authors of the study said the differences between the countries was partly explained by how quickly patients get a diagnosis and then prompt access to effective treatment.. Advertisement. Cancer Research UKs clinical adviser, John Butler, who co-authored the study and is a consultant surgeon at the Royal Marsden Hospital in London, said: For lung, ovarian, and oesophageal cancer in particular, survival has increased largely because the quality of surgery ...
The UK has the lowest survival rates for five of seven key cancers among some of the worlds richest nations. Although survival rates are improving, the UK came bottom of the table for bowel, lung, pancreatic, stomach and rectal cancer.. Cancer Research UK analysed 3.9 million cancer cases between 1995 and 2014 in seven comparable high-income countries with universal healthcare (Australia, Canada, Denmark, Ireland, New Zealand, Norway and the UK).. Only for oesophagus and ovary cancer did UK do better than some of the other countries.. The authors of the study said the differences between the countries was partly explained by how quickly patients get a diagnosis and then prompt access to effective treatment.. Advertisement Cancer Research UKs clinical adviser, John Butler, who co-authored the study and is a consultant surgeon at the Royal Marsden Hospital in London, said: For lung, ovarian, and oesophageal cancer in particular, survival has increased largely because the quality of surgery has ...
The results of a pilot study to investigate the technique are published online today in The British Journal of Radiology.. Some prostate cancers can be aggressive while others never require treatment. Men diagnosed with early stage prostate cancer therefore have the option of delaying therapy and opting instead for Active Surveillance - regular monitoring by biopsy and testing levels of prostate specific antigen (PSA) in the blood. However, biopsies are invasive and carry side-effects while PSA testing can be inaccurate, so scientists are looking for other ways to monitor cancer growth in these men and determine if treatment is needed.. An accurate test is particularly important as recent figures show the proportion of men who opted for Active Surveillance increased from zero to 39 per cent between 2002 and 2006, and has likely become more common since NICE made it a standard treatment option in 2008*.. Scientists at The Institute of Cancer Research (ICR) and The Royal Marsden Hospital used a ...
Presentations at the 4th IMPAKT Breast Cancer Conference. New findings presented at Europes leading breast cancer translational research conference this year shed new light on the many biological differences between individual breast cancers.. Focused on the biological features that make tumors more or less sensitive to important therapies, the new studies will help doctors make crucial choices about the most appropriate treatment for millions of patients.. Despite major advances in the treatment of breast cancer many patients continue to relapse and die from the disease, noted Prof Mitch Dowsett from the Royal Marsden Hospital, UK, former IMPAKT Chair. Studies presented at this years IMPAKT further emphasize the potential of biomarkers to identify new targets for developing therapy to disease that is resistant to our current treatments as well as the groups of patients most likely to respond to the new treatments. In this way we are progressively reducing the threat posed by a diagnosis of ...
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... "Current Topics in Microbiology and Immunology. Current Topics in Microbiology and Immunology. 325: 361-382. doi:10.1007/978-3- ... "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24, 2013.. ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...
ICH E9: Statistical principles for clinical trials section III provides a general overview of common designs in clinical trials ... the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. ICH E1: Population ... CPMP/EWP/2330/99: Application with 1. Meta-analyses; 2. One pivotal study (EMA) provides guidance on two topics: ... EMA/286914/2012: Multiplicity issues in clinical trials (EMA) addresses the multiplicity in the clinical trials in the context ...
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 ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". U.S. National ... This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a ...
... at the time of conducting phase-2 clinical trials. Generally, the PAT initiative from FDA is only one topic within the broader ...
"Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ... 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 ...
Discussion topics when setting up an experimental design[edit]. An experimental design or randomized clinical trial requires ... A good way to prevent biases potentially leading to false positives in the data collection phase is to use a double-blind ... James Lind carried out a systematic clinical trial to compare remedies for scurvy.[1] This systematic clinical trial ... Systematic clinical trials[edit]. This section possibly contains original research. Please improve it by verifying the claims ...
Preliminary data from a phase 1 clinical trial indicate that 92% of participants would be protected from Zika infection. "HJF ... Blank C (November 30, 2016). "Human trials of Zika vaccine underway". Drug Topics. "Human Trials Begin for Army-Developed Zika ... a phase 1b, randomised, double-blind, placebo-controlled clinical trial". Lancet. 385 (9977): 1545-54. doi:10.1016/S0140-6736( ... phase 1, randomised, double-blind, placebo-controlled clinical trials". The Lancet. 391 (10120): 563-571. doi:10.1016/S0140- ...
In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... oral bioavailability in humans in a phase I clinical trial. A single dose of 200 mg results in an AUC value of 900 ng*h/ml. The ... a randomized Phase 2 clinical trial". Nature Medicine. 13 (9): 1102-7. doi:10.1038/nm1632. PMID 17767166. Lebois EP (2008). " ...
In a phase I clinical trial, TIK-301 was shown to be effective as a chronobiotic at a dose of 5 mg/L, but not in lower doses. ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. Mody S, Hu Y, Ho MK, Wong ... TIK-301 was in phase II clinical trials in 2002. In 2004, TIK-301 was designated an orphan drug by the FDA. In 2005, TIK-301 ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ...
There have been some preclinical trials in mice and rats, but no phase-1 tests or clinical trials of safety in humans, as of ... foot baths Colon cleansing Ear candling Oil pulling Skeptical movement Placebo Quackery Skepticism List of topics characterized ... no clinical trials have tested them on humans, as of November 2019[update]. Reports of adverse events are numerous, including ...
From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... They will then seek approval and request a time and date to carry out the implementation phase. In rare cases where the ... 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. ...
... the legislation included language guaranteeing that women and minorities were included in all federal health clinical trials ... The legislation would phase out the use of eight major classes of antibiotics in healthy food-producing animals, while allowing ... She cited her scientific training as the impetus for her dedicated interest on the topic, stating in an interview, "It wasn't ... Previously, all NIH-funded research was done on white males, even in trials related to predominantly female diseases such as ...
... at Clinical trial number NCT01086657 for "An Open-Label, Randomized Phase I Study in Healthy Adults of the ... Drug Topics. Retrieved January 27, 2020. Fast, Patricia E; Cox, Josephine H (September 1, 2015). "An influenza vaccine pill-can ... at Clinical trial number NCT03450915 for "A Pivotal Trial to Assess the Safety and Clinical Efficacy of the ... "BiondVax Announces Topline Results from Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine Candidate". BiondVax. ...
July 2017). "Low-dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial". Annals of Clinical ... Zhang YL, Keng YF, Zhao Y, Wu L, Zhang ZY (May 1998). " ... Suramin has been studied in a mouse model of autism and in a small phase I/II human trial. "Suramin Injection Advanced Patient ... Suramin was studied as a possible treatment for prostate cancer in a clinical trial. ...
When three surgeries and intense chemotherapy failed, she underwent a clinical trial that eradicated the cancer in 1997 but ... Her Ph.D. research focused phase diagram of block copolymers. After completing her Ph.D., Mayes worked two years as Visiting ... Mayes research led to breakthroughs in many topics, including the development of polymeric electrolytes for lithium-ion ...
In a placebo controlled Phase II clinical trial with 351 subjects, eplivanserin reduced the sleep latency by 39 minutes (versus ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ...
Helgadóttir FD, Menzies RG, Onslow M, Packman A, O'Brian S (2009). "Online CBT II: A Phase I Trial of a Standalone, Online CBT ... "Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) Versus Acceptance and Commitment Therapy (ACT) for Mixed ... The research conducted for CBT has been a topic of sustained controversy. While some researchers write that CBT is more ... In this study, the researchers analyzed several clinical trials that measured the efficacy of CBT administered to youths who ...
It is the first telomerase inhibitor to enter clinical trials. It is currently in Phase 2/3 trials for various cancer types. ... 2020). "Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials". Current Topics in Medicinal Chemistry. 20 (6 ...
Climate ensemble Climograph Clinical significance Clinical study design Clinical trial Clinical utility of diagnostic tests ... Pharmaceutical statistics Phase dispersion minimization Phase-type distribution Phi coefficient Phillips-Perron test Philosophy ... of graphical methods List of fields of application of statistics List of stochastic processes topics Lists of statistics topics ... clinical trials) Minimum chi-square estimation Minimum distance estimation Minimum mean square error Minimum-variance unbiased ...
The trials can be national or international and, regarding the phase they are in either recruiting, ongoing or finished. The ... The clinical trials listed on Orphanet comprise interventional studies aiming to evaluate a drug (substance, or combination) to ... The Orphanet reports comprises a serie of texts covering topics relevant to all rare diseases. New reports are regularly put ... "Search for a clinical trial". Orphanet. Retrieved 15 April 2021. "Search for a patient organisation". Orphanet. Retrieved 15 ...
A randomized single-blind clinical trial", M. R. Popovic, N. Kapadia, V. Zivanovic, J. C. Furlan, B. C. Craven, and C. ... Pappas, I.P.I.; Popovic, M.R.; Keller, T.; Dietz, V.; Morari, M. (June 2001). "A reliable gait phase detection system". IEEE ... Topics in Spinal Cord Injury Rehabilitation. 14 (4): 62-68. doi:10.1310/sci1404-62. ISSN 1082-0744. Popovic, M.R.; Keller, T.; ... A Randomized Clinical Trial". Neurorehabilitation and Neural Repair. 25 (5): 433-442. doi:10.1177/1545968310392924. ISSN 1545- ...
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 ...
Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval. ... Cockbain J (2007). "Intellectual ... The objective of this drug discovery phase is to synthesize lead compounds, new analogs with improved potency, reduced off- ... Current Topics in Medicinal Chemistry. 4 (6): 569-80. doi:10.2174/1568026043451168. PMID 14965294. Fruber M, Narjes F, Steele J ... Clinical development The hit to lead stage starts with confirmation and evaluation of the initial screening hits and is ...
... was first studied in a phase I clinical trial in 1987 and the results of the first phase II clinical trial in ... Suzuki H, Kamiya N, Imamoto T, Kawamura K, Yano M, Takano M, Utsumi T, Naya Y, Ichikawa T (October 2008). "Current topics and ... A phase III clinical trial of bicalutamide in combination with an ethinylestradiol-containing combined oral contraceptive for ... Bicalutamide has also been studied in a phase II clinical trial for ovarian cancer in women. Bicalutamide has been studied in ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... "Clinical Microbiology Reviews. 11 (3): 430-9. doi:10.1128/CMR.11.3.430. PMC 88889. PMID 9665976.. .mw-parser-output cite. ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Despite the side effects, its potential benefit has led to a few clinical trials.[9] ... As of 2016, several TLR ligands were in clinical development or being tested in animal models as potential adjuvants.[24] ... "T-cell priming by dendritic cells in lymph nodes occurs in three distinct phases". Nature. 427 (6970): 154-9. Bibcode:2004Natur ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ...
Results of a phase III clinical trial for the treatment of Alzheimer's disease were reported in September 2017. The trial ... Current Topics in Medicinal Chemistry. 10 (2): 207-21. doi:10.2174/156802610790411036. PMID 20166958. Lowe, Derek (12 May 2015 ... Intepirdine also entered clinical trials for dementia with Lewy bodies, also with negative results. Consequently, Axovant ... GlaxoSmithKline for the treatment of Alzheimer's disease and demonstrated some preliminary efficacy in phase II clinical trials ...
... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... was reported as showing that the medical profession had responded to the growth of CAM in three phases, and that in each phase ... 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 ...
"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 ... The response to the epidemic then moved to a second phase, as the focus shifted from slowing transmission to ending the ...
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... BEIR VII Phase 2. Washington, DC: The National Academies Press. ISBN 0-309-09156-X.. CS1 maint: Multiple names: authors list ( ... 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 ...
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 ... When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more ... Fox-Rawlings S,. Gottschalk L.B., Doamekpor L., Zuckerman D.M. (2018) Diversity in Medical Device Clinical Trials: Do We Know ...
"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 ...
Phase-locking to stimulus frequencies has been shown in the auditory nerve,[5][6] the cochlear nucleus,[5][7] the inferior ... 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 ... Evoked gamma activity was found after the onset of each tone in the rhythm; this activity was found to be phase-locked (peaks ...
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 ...
... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ... 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 ... 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 ... Temporal protein biomarkers in tracking different phases of TBIEdit. A continuum of protein biomarkers in tracking different ... 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.. ...
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 ... Although he considered bisexuality inherent in all people, and said that most have phases of homosexual attraction or ... Journal of Consulting and Clinical Psychology, 71 (1), pp. 53-61. ...
This system was phased out in 1972-1977 in favor of the modern system where grades 1-9 are mandatory. After the age of 15, the ... "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 ...
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 ... "Measurement of intracellular vitamin C levels in human lymphocytes by reverse phase high performance liquid chromatography ( ... A meta-analysis of 44 clinical trials has shown a significant positive effect of vitamin C on endothelial function when taken ...
... 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. ... a phase II study". Japanese Journal of Clinical Oncology. 35 (2): 68-73. doi:10.1093/jjco/hyi021. PMID 15709089.. ... American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 35 (36): e194- ...
... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ... 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 ... Evian, Clive (2006). Primary HIV/AIDS care: a practical guide for primary health care personnel in a clinical and supportive ...
20-year results of a randomized trial". Journal of Clinical Oncology. 32 (8): 791-7. doi:10.1200/JCO.2013.50.6600. PMID ... Nerve damage from ionizing radiation occurs in phases, the initial phase from microvascular injury, capillary damage and nerve ... Wikibooks has a book on the topic of: Radiation Oncology. Information. *Human Health Campus The official website of the ... Ang, K. Kian (October 1998). "Altered fractionation trials in head and neck cancer". Seminars in Radiation Oncology. 8 (4): 230 ...
Handbook of Clinical Neurology. 106. pp. 527-40. doi:10.1016/B978-0-444-52002-9.00031-0. ISBN 978-0-444-52002-9. PMID 22608642. ... Delayed sleep phase disorder (DSPD), inability to awaken and fall asleep at socially acceptable times but no problem with sleep ... "UTCAT2395, Found CAT view, CRITICALLY APPRAISED TOPICs". Retrieved 2016-03-08.. ... Stradling, J; Roberts, D; Wilson, A; Lovelock, F (1998). "Controlled trial of hypnotherapy for weight loss in patients with ...
... the drug may be used in human clinical trials. Human trials with all of the below HDAC inhibitors are extremely variable and ... Sodium phenylbutyrate phase II human triasl with 12 to 15 g/day showed restored mRNA levels of Htt mutant repressed genes but ... "British Journal of Clinical Pharmacology. 75 (4): 1152-3. doi:10.1111/j.1365-2125.2012.04444.x. PMC 3612735. PMID 22905989.. ... Human trials are extremely variable showing increased SMN2 levels and increased muscle strength in some trials and absolutely ...
Institute on Aging and the National Institute of Diabetes and Digestive and Kidney Diseases mounted the CALERIE clinical trials ... CR at three sites for six months to a year in Phase 1 and for two years in Phase 2.[40] ... "Journal of Clinical Densitometry. 16 (4): 450-454. doi:10.1016/j.jocd.2013.08.010. PMC 5321047. PMID 24063845.. ... "The American Journal of Clinical Nutrition. 88 (1): 1-11. doi:10.1093/ajcn/88.1.1. PMC 2674146. PMID 18614716.. ...
... and has now successfully concluded Phase I clinical trials. There has been some research success towards a "universal flu ... Current Topics in Microbiology and Immunology. 283. pp. 313-42. doi:10.1007/978-3-662-06099-5_9. ISBN 978-3-642-07375-5. . PMID ... a meta-analysis of published and unpublished clinical trials". Family Practice. 30 (2): 125-33. doi:10.1093/fampra/cms059. PMID ... Japanese Journal of Clinical Medicine. 55 (10): 2505-11. PMID 9360364.. *^ Smith W, Andrewes CH, Laidlaw PP (1933). "A virus ...
2016). "Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials". JAMA ... Late-phase response[edit]. After the chemical mediators of the acute response subside, late-phase responses can often occur due ... a collection of resources on the topic of food allergies and intolerances ... This phase can either subside or progress into a "late-phase reaction" which can substantially prolong the symptoms of a ...
"Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes". Br J Psychiatry ... Clinical outcome evidence[edit]. A number of studies have been carried out to see whether the early psychosis approach reduces ... where thoughts unrelated to a common topic appear uncontrollably; referential ideation that is immediately corrected; and other ... the TIPS early detection randomised control trial in Norway;[17] and the Danish OPUS trial.[16] In 2001, the United Kingdom ...
"Data sharing platforms for de-identified data from human clinical trials". Clinical Trials: 1740774518769655. doi:10.1177/ ... Computer models are used to examine various topics such as how exercise affects obesity, healthcare costs, and many more.[35] ... developed computerized systems to automate many aspects of multi-phased health checkups. These systems became the basis the ... Common data elements (CDEs) in clinical research[edit]. Ability to integrate data from multiple clinical trials is an important ...
Clinical research and experimental design. Overview. *Clinical trial *Trial protocols. *Adaptive clinical trial ... A Phase I discovery will be followed by Phase II reproductions as a drug develops towards commercial production. In recent ... The values obtained from distinct experimental trials are said to be commensurate if they are obtained according to the same ... decades Phase II success has fallen from 28% to 18%. A 2011 study found that 65% of medical studies were inconsistent when re- ...
... clinical hair loss (telogen effluvium) may occur.[citation needed] A disruption of the growing phase causes abnormal loss of ... Baldness is the partial or complete lack of hair growth, and part of the wider topic of "hair thinning". The degree and pattern ... Dietary supplements are not typically recommended.[30] There is only one small trial of saw palmetto which shows tentative ... Each cycle consists of a long growing phase (anagen), a short transitional phase (catagen) and a short resting phase (telogen ...
and Sanofi affiliate Shantha Biotechnics are currently in Phase III clinical trials.[37][38] ... "ROTAVAC clinical trial results , DEFEATDD.ORG - Resources to defeat diarrheal disease". Archived from the ... Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe ... These novel approaches are being pursued using animal models and, in the case of the NRRV P2-VP8 candidate, clinical trials.[42 ...
"ACL Program - Bridge-Enhanced ACL Repair (BEAR) Clinical Trial". Retrieved 25 April 2016.. ... Phase 2[edit]. Many of the goals from phase I will be continued to the following phases until they have been reached. Some of ... "Anterior Cruciate Ligament (ACL) Injuries - Topic Overview". Retrieved 25 April 2016.. ... Phase 5[edit]. This is the last phase of the recovery rehabilitation. Phase V includes returning to sports after being cleared ...
... a meta-analysis of 26 clinical trials reported that high-polyphenol olive oil improved measures of total cholesterol, HDL ... "Mafia Control of Olive Oil the Topic of '60 Minutes' Report". Olive Oil Times. 3 January 2016. Retrieved 28 January 2016.. . ... a drought during the flowering phase, for example, can result in a lower quality (virgin) oil. It is worth noting that olive ... "Clinical Chemistry. 46 (7): 976-988.. CS1 maint: Uses authors parameter (link) ...
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. ...
Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the ... Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence. ... about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials. ... Clinical Trials, Phase I as Topic. Clinical Trials, Phase II as Topic ...
ImmusanTs Celiac Vaccine Passed Phase I Clinical TrialsCeliac.comHer son was diagnosed with celiac disease in 2006, at the age ... Topics. * Need Recovery Help Please. By ChargersFan, 46 minutes ago. in Celiac Disease - Post Diagnosis, Recovery/Treatment(s) ... ImmusanTs Celiac Vaccine Passed Phase I Clinical Trials - * Join our community!. Do you have questions about celiac ... ImmusanTs Celiac Vaccine Passed Phase I Clinical Trials. Her son was diagnosed with celiac disease in 2006, at the ...
... clinical trials in CLL but final approval to market the drug will depend on the success of the latest Phase-III clinical trial ... Genmab has just announced the clinical trial on, with all the details. This is a multi-center trial, ... Phase III Clinical Trial of HuMax-CD20 in Refractory CLL The scientific name for HuMax-CD20 is ofatumumab - not something that ... The results of this Phase III clinical trial will go a long way to show if this is indeed the case. I am keeping my fingers ...
Covid 19 phase Blogs, Comments and Archive News on ... Covid 19 phase Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. ... Phase II trial finds Chinese COVID-19 vaccine is safe, induces immune response. 21 Jul, 2020, 03.57 PM IST. A phase II clinical ... Phase-I human clinical trial of potential COVID-19 vaccine: Man given first dose at AIIMS. 24 Jul, 2020, 04.24 PM IST. Already ...
Our experience demonstrates the feasibility of implementing this design in multi-institutional trials and the possibility of ... Clinical Trials, Phase I as Topic * Dose-Response Relationship, Drug * Glioblastoma / drug therapy* ... Methods: The continual reassessment method (CRM) was modified for use in phase I trials conducted through the New Approaches to ... Practical implementation of a modified continual reassessment method for dose-finding trials Cancer Chemother Pharmacol. 1998; ...
Larger, prospective studies of markers are needed to assess their clinical value. ... Clinical Trials, Phase II as Topic * Colitis, Ulcerative / diagnosis * Colitis, Ulcerative / drug therapy* ... In the placebo-controlled trial, clinical remission was defined as total Mayo Clinic Score ≤2, with no individual subscore ,1, ... a retrospective analysis of data collected from 110 patients with UC who participated in a phase 2 placebo-controlled trial of ...
phase 1 clinical trial (topic). *phase 2 clinical trial (topic). *pleura effusion ... Thermal ablative therapies used in clinical practice to date include Radiofrequency Ablation (RFA), Microwave Ablation (MWA) ...
Clinical Trials, Phase Iii As Topic. Comparative studies to verify the effectiveness of diagnostic, therapeutic, or ... Clinical Trials [13282 Associated Clinical Trials listed on BioPortfolio]. Long Term Quality of Life in Melanoma Patients in ... Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields ... Analysis from phase 2 and 3 clinical trials.. Previous analyses of BREAK-2 and BREAK-3 showed that durable outcomes lasting ≥3 ...
Clinical Trials, Phase Iii As Topic. Comparative studies to verify the effectiveness of diagnostic, therapeutic, or ... Clinical Trials [8497 Associated Clinical Trials listed on BioPortfolio]. Predicting Physical Activity Change: an Epidemiologic ... Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... Topics. All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ...
This review provides an overview of naptumomab, an immunotoxin, with encouraging clinical activity in Phase I trials. AREAS ... Clinical Trials, Phase I as Topic. Drug Design. Enterotoxins / adverse effects, chemistry, pharmacokinetics, pharmacology, ... This review provides an overview of naptumomab, an immunotoxin, with encouraging clinical activity in Phase I trials. AREAS ... 6854663 - Cerebral aneurysm: report of two cases and clinical update.. 3701343 - Clinical signs in the wernicke-korsakoff ...
Maryland-based Novavax phase 3 clinical trial expands to include children 12 to 17. - Hallie Miller. A ... Maryland-based COVID-19 vaccine producer is expanding its late-stage Phase 3 clinical trial study to include children ages 12 ...
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... "Current Topics in Microbiology and Immunology. Current Topics in Microbiology and Immunology. 325: 361-382. doi:10.1007/978-3- ... "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24, 2013.. ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...
Clinical Expertise *Clinical Trial. *Clinical Trials, Phase II as Topic. *Drugs, Investigational ... Clinical Trials Clinical trials are invaluable in testing new treatments, drugs and technologies. ... We plan to conduct a clinical trial to test this hypothesis in the setting of the cardiac operating room at Childrens ... Were challenging existing models of care with new ideas across the spectrum of discovery-from basic science, to clinical ...
Clinical Expertise *Clinical Trial. *Clinical Trials, Phase II as Topic. *Drugs, Investigational ... Clinical Trials Clinical trials are invaluable in testing new treatments, drugs and technologies. ... Were challenging existing models of care with new ideas across the spectrum of discovery-from basic science, to clinical ...
Clinical Trials, Phase I as Topic. *Biomarkers, Pharmacological. *Precision Medicine. *. Office. 203.785.6879 ... Director, Transfusion Medicine Service; Medical Director, Clinical Cell Processing Laboratory; Medical Director, Advanced Cell ... Professor; Vice Chair for Clinical Research, Radiology & Biomedical Imaging; Section Chief, Interventional Radiology ...
Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and ... Specialized Terms: Clinical studies; Methodology. Extensive Research Description. *Genetic and Brain Image Analysis of ... Clinical Studies of Methods to Stop/Prevent Smoking. *Biostatistical Design and Analysis Issues for Detection of Rare Adverse ...
Topic(s). * HEALTH.2012.1.4-4 - Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach ... 2 Phase Ib and 2 Phase IIa clinical trials (MDEX Consortium in collaboration with Sarepta Therapeutics; a Dutch Consortium) ... A phase I/IIa clinical trial in Duchenne muscular dystrophy using systemically delivered morpholino antisense oligomer to skip ... We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. ...
nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to... ... We anticipate initiating the second Phase 2 trial and reporting topline results from the first Phase 2 clinical trial during ... of topline data from the initial Phase 2 clinical trial and the timing of initiation of a second Phase 2 clinical trial and the ... Patients who complete this first Phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, Phase 2 extension ...
Arsanis said today it has ended a Phase II trial for its sole clinical-phase candidate, ASN100, concluding that the monoclonal ... Arsanis expects to advance ASN500 into Phase I clinical trials in 2019, Dr. Russo added. ... The committee recommended that trial enrollment be discontinued.. The Phase II trial (NCT02940626) was a double-blind, placebo- ... Topics *. AllBioprocessingCancerDrug DiscoveryOMICsTranslational MedicineGenome Editing. Tech Exclusives ...
... tralokinumab has failed its second and third Phase III trials in severe, uncontrolled asthma ... FDA Places Another Clinical Hold on Trial for Solids DMD Gene Therapy. ... Topics *. AllBioprocessingCancerDrug DiscoveryOMICsTranslational MedicineGenome Editing. Solid Biosciences ... The company submitted data from the Phase II ACE-LY-004 open-label, single-arm trial in 124 adult patients with relapsed or ...
PRVB, a clinical stage biopharmaceutical company dedicated to intercepting and preventing... ... The Phase 1b PULSE (Provention ULcerative colitis Safety/PK/PD Evaluation) clinical trial was a randomized, double-blind, ... Provention Bio Announces Top-Line Results from its Phase 1b PULSE Clinical Trial of PRV-300 in Patients with Moderate-to-Severe ... ...
Clinical Trial Registration-. URL: Unique identifier: NCT01805895.. View on Journal Site ... This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. Adults ≥18 years with ... intravenous minocycline is an excellent candidate for a prehospital treatment trial. ...
... including a late breaking poster on the clinical data from the ongoing Phase 1 study of IL-15 superagonist SO-C101 for the ... Keywords: Humans; Clinical Trials, Phase I as Topic; Medical Oncology; IL15 protein, human; Interleukin-15; Receptors, ... Cytune Pharma is responsible for the clinical development of SO-C101 and SOTIO is a sponsor of the Phase 1 clinical trial. ... SOTIO will present three posters, including a late breaking poster on the clinical data from the ongoing Phase 1 study of IL-15 ...
Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Clinical Professor of Epidemiology. Dr. Robert Hecht is the President of Pharos Global Health Advisors. He has more than 30 ... Grau is a clinical psychologist with training in health psychology and expertise in identifying the cognitive and emotional ... Assistant Clinical Professor of Public Health. Dr. Unni Karunakara was International President of Médecins Sans Frontières / ...
... are intended to expedite the clinical evaluation of new molecular entities. The exploratory IND supports the performance of ... Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA)s recent exploratory ... Phase 0 clinical trials: conceptions and misconceptions Cancer J. May-Jun 2008;14(3):133-7. doi: 10.1097/PPO.0b013e318172d6f3. ... Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA)s recent exploratory ...
Interventional (Clinical Trial) Estimated Enrollment :. 70 participants. Allocation:. Randomized. Intervention Model:. Parallel ... PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS ... Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment. The safety and ... Identifier: NCT01203397. Recruitment Status : Suspended (Study suspended by decision strategically.) First ...
Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Cytarabine/therapeutic use ; Enzyme Inhibitors/ ... The authors discuss the results of a phase I and three phase II trials reporting the efficacy of STI571 as treatment for CML ...
Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative ... Clinical Trials, Phase III as Topic*. *Lung Neoplasms/drug therapy*/mortality*. *Small Cell Lung Carcinoma/drug therapy*/ ... pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an ... pone-0042798-g002: Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an ...
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of ... the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions,… ... After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores ... The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues ...
  • 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. (
  • 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. (
  • 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. (
  • Adenovirus Vaccine Efficacy Trial Consortium (2013). (
  • The Phase II trial ( NCT02940626 ) was a double-blind, placebo-controlled, superiority global study conducted at approximately 65 sites, and was designed to assess the efficacy and safety of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients, an indication for which there are no approved therapies. (
  • 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 authors discuss the results of a phase I and three phase II trials reporting the efficacy of STI571 as treatment for CML patients and propose two simplified algorithms that may help to guide decision-making for the individual patient. (
  • 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. (
  • Lenabasum Fails to Show Efficacy in Diffuse Cutaneous Scleroderma (dcSSc), Phase 3 Trial Shows. (
  • Clinical efficacy, including functional tests such as the six-minute walk test (6MWT), will be assessed at regularly scheduled study visits. (
  • LOS ANGELES, Calif. - (SEND2PRESS NEWSWIRE) - Epeius Biotechnologies Corp. announced today that a Phase I clinical trial has opened in New York to test the safety and efficacy of Rexin-G, the leading tumor-targeted gene delivery system (vector) developed for the treatment of metastatic colon and pancreatic cancer. (
  • At the recent International Myeloma Workshop in Paris, we noted that in multiple clinical studies carfilzomib has a "positive efficacy signal" with an encouraging safety profile, including low rates of neuropathy. (
  • The progress in the KL1333 programis a great step towards our plan of taking the project to a clinical efficacy study next year and important to our company. (
  • The first SIMPLE trial tackled the safety and efficacy of 5-day and 10-day remdesivir treatment for severe COVID-19 symptoms and results were published in The New England Journal of Medicine on May 27. (
  • These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trials, product development activities and regulatory approval requirements, including the risk that data from the ongoing clinical programs may not support continuation of the study due to safety, efficacy or other reasons in AML or MDS. (
  • The trial, Dr. Shah noted, was designed to estimate the efficacy of dasatinib and was therefore not powered to detect significant differences. (
  • In addition to the safety and efficacy results, the trial also indicated that the fever associated with malaria was on average eliminated within 16 hours for the same group of patients. (
  • CPMP/EWP/482/99: Switching between superiority and non-inferiority (EMA) addresses the issues of superiority, non-inferiority and equivalence from the perspective of an efficacy trial with a single primary variable. (
  • PRAGUE, Czech Republic, November 04, 2020 / B3C newswire / -- SOTIO , a clinical stage immuno-oncology company, and Cytune Pharma, both owned by PPF Group, today announced that they will present a late breaking poster highlighting new clinical data on SO-C101 at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting to be held virtually November 9-14, 2020. (
  • Western Equine Encephalitis disease overview, 2020 pipeline review, insights into leading companies, dominant mechanism of action, majority of administration route of Western Equine Encephalitis therapies, pipeline by phase and others are included. (
  • (
  • This is a randomized trial funded by the Canadian Complementary Medicine Research Fund and is expected to be completed by 2020. (
  • 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. (
  • 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. (
  • The trial is limited to CLL patients who have had fludarabine in the past and subsequently relapsed. (
  • The target profile of Campath relapse suggests patients recruited for this HuMax-CD20 trial are likely to have bulky lymph nodes, something that stymies even Campath. (
  • Our implementation of the CRM uses (1) a simple dose-toxicity model to guide data interpolation, (2) groups of three patients to minimize calculations and stabilize estimates, (3) investigators' clinical knowledge or opinion in the form of data to make the process easier to understand, and (4) a flexible computer program and interface to facilitate calculations. (
  • The modified CRM was used in two dose-finding trials of 9-aminocamptothecin in patients with newly diagnosed and recurrent glioblastoma who were taking anticonvulsant medication. (
  • Our experience demonstrates the feasibility of implementing this design in multi-institutional trials and the possibility of performing dose-finding studies that require fewer patients than conventional methods. (
  • We compared differences in colonic expression of ITGAE and other genes between patients who achieved clinical remission with etrolizumab vs those who did. (
  • We performed a retrospective analysis of data collected from 110 patients with UC who participated in a phase 2 placebo-controlled trial of etrolizumab, as well as from 21 patients with UC or without inflammatory bowel disease (controls) enrolled in an observational study at a separate site. (
  • Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. (
  • During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. (
  • Through this study we aimed to categorize the risk for cardiovascular events in patients with ULMCA disease using simple clinical descriptors. (
  • Patients who complete this first Phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, Phase 2 extension clinical trial that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels. (
  • Arsanis said today it has ended a Phase II trial for its sole clinical-phase candidate, ASN100, concluding that the monoclonal antibody combination would fail to prove its effectiveness in high-risk, mechanically ventilated patients with Staphylococcus aureus pneumonia. (
  • The trial had an estimated enrollment of 354 patients and an estimated primary completion date of October 8. (
  • Tralokinumab also missed its primary endpoint in the 140-patient TROPOS trial of a statistically significant reduction in oral corticosteroid (OCS) use when added to standard of care in patients dependent on OCS. (
  • The company submitted data from the Phase II ACE-LY-004 open-label, single-arm trial in 124 adult patients with relapsed or refractory MCL. (
  • 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). (
  • 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. (
  • 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. (
  • The objectives of a phase 0 cancer clinical trial are to establish at the very earliest opportunity-before large numbers of patients have been accrued and exposed to potential drug-associated toxicity-whether an agent is modulating its target in a tumor, and consequently whether further clinical development is warranted. (
  • Treatment-related death in patients with small-cell lung cancer in phase III trials over the last two decades. (
  • In total, 97 trials including nearly 25,000 enrolled patients were analyzed. (
  • Time trends in the demographics of patients randomized in phase III trials.A good PS was defined as an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. (
  • The dosage level is slowly increased as new patients enter the trial. (
  • For this reason, some phase I trials may be limited to patients whose condition cannot be helped by other known or proven treatments. (
  • Conclusion If a significant number of patients (usually at least one-fifth) respond favorably to a treatment, it proceeds to Phase III. (
  • In the trial, patients were given increasing doses of oral oleander extract in cycles where the drug was administered for 21 out of 28 days in each cycle. (
  • Even if funding is found, it could take years before the new drug goes through the entire trial process and is available for cancer patients. (
  • In a Phase II clinical trial, two-year survival among patients with stagesIIIB and IV disease who received Lucanix(R) was significantly longer than thatof individuals being treated with the current standard of care. (
  • I am very excited to be apart of this confirmatory effort, and to be able to offer this uniquetreatment option to my patients," said Dr. Lyudmila Bazhenova, principalinvestigator of the STOP trial at the Rebecca and John Moore's Cancer Centerof UCSD. (
  • I am confident that this Phase III trialwill establish Lucanix(R) as a viable treatment option for patients with thisdreaded disease," said Dr. Habib Fakhrai, president and co-founder of NovaRx. (
  • In Phase II testing, 50 percent of patients entering the trial with stabledisease who received Lucanix(TM) following one frontline regimen ofchemotherapy lived more than 44 months, compared to less than 10-12 months forsuch patients under the current standard of care. (
  • We also have a robust clinical trials program, offering patients the option to access some of the latest treatments before they are widely available elsewhere. (
  • The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma and by having the potential to directly impact the quality of patient care. (
  • The Phase I study of IBI302 is an open-label, multi-center, dose-escalation clinical trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with nAMD. (
  • BOLD ), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, today announced that new interim data from ASPIRO, the Phase 1/2 clinical trial of AT132 in patients with X-linked Myotubular Myopathy (XLMTM), will be presented at the 23rd International Congress of the World Muscle Society (WMS) in Mendoza, Argentina. (
  • The preliminary results are based on 320 evaluable events that occurred inthe clinical trial out of a total of 428 patients randomized. (
  • Statistically significant results were achieved in evaluable UMM patientswho failed a prior chemotherapy regimen before entering this clinical trial.Patients who received ONCONASE plus doxorubicin experienced a MST of 10.5months compared with 8.7 months for those patients who received doxorubicin(unadjusted log rank p=0.016). (
  • This comparative Phase II study is expected to recruit a total of 180 patients from approximately 20 sites in the USA and Central America. (
  • The study is expected to be completed in 2010 and is a critical part of Novexel's clinical development plan for NXL103 which is focused on its potential to be used in hospitals and out-patients as an oral agent for the treatment of infections caused by Gram-positive organisms, including MRSA. (
  • Elderly patients with heart failure who see a pharmacist once a week are more likely to take their tablets and be active in daily life, according to late breaking results from the PHARM-CHF randomised controlled trial presented at Heart Failure 2019. (
  • The AMARANTH trial randomized patients with early Alzheimer's disease to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for 104 weeks. (
  • Patients who completed the AMARANTH trial were given the opportunity to enroll in the AMARANTH extension trial, where all patients received active treatment. (
  • An Update on the PARP Inhibitor Olaparib in mCRPC Patients: Review of the Phase 2 Results & A First Look at the Phase 3 Study. (
  • Clinical trials of Rexin-G have now been expanded to include patients with colorectal cancer that has spread to the liver. (
  • I write about the latest science in ALS and aim to provide a layman's overview of topics important to patients, caregivers, clinicians and researchers alike. (
  • is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients. (
  • NLNK ) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. (
  • We have made significant progress in our Phase 3 trial with algenpantucel-L for resected pancreas cancer patients since its launch in May of 2010," commented Dr. Charles Link, Chief Executive Officer of NewLink. (
  • FUJIFILM Corporation (President: Shigehiro Nakajima) is announcing the progress in a Phase I clinical trial of anti-cancer agent FF-10501 in the United States in patients with relapsed or refractory myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). (
  • Fujifilm initiated the Phase I clinical trial of FF-10501 in patients with blood cancer at MD Anderson Cancer Center in the United States in August 2014. (
  • In one trial a higher percentage of patients taking the drug had to drop out, citing side effects like anemia. (
  • The SIMPLE trial found the 5-day remdesivir treatment arm to be 65% more likely to have clinical improvement compared with standard of care alone in patients with moderate COVID-19. (
  • Gilead announced results from the phase 3 SIMPLE trial, which found that 5-day treatment with remdesivir in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) symptoms and pneumonia resulted in significantly greater clinical symptom improvement versus treatment with standard of care alone, according to a press release. (
  • This second SIMPLE trial has added significant data to the growing body of evidence from prior studies demonstrating benefit of remdesivir in hospitalized patients with COVID-19. (
  • The multi-center, open-label, randomized, phase 3 SIMPLE trial found that patients in the 5-day remdesivir treatment arm were 65% more likely to have clinical improvement at day 11 compared with patients receiving standard of care. (
  • The SIMPLE trial incorporated hospitalized patients with COVID-19 showing evidence of pneumonia without reduced oxygen levels. (
  • Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course," said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences. (
  • Patients who participated in clinical trials were unaware of the particulars of the research (e.g., randomization, treatment arms, etc.) or that the treatment was experimental in nature [ 7 - 9 ], and information presented in the consent form was not always taken into account when making medical decisions [ 10 ]. (
  • Physicians have significant influence on medical decisions that are made by their patients [ 16 - 18 ], and communication with the physician during clinical encounters is an important factor in the final decision to participate in clinical trials [ 19 - 21 ]. (
  • In a study involving oncology patients, 68% of the time physicians recommended that their patients participate in a clinical trial, which was related to the resultant decision to participate [ 22 ]. (
  • OICC and CCNM are collaborating with the Ottawa Hospital Research Institute on an 11-year pragmatic randomized clinical trial to explore the impact of integrative cancer care for patients with lung and gastroesophageal cancers. (
  • No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA. (
  • Based on the totality of the data we have for RVU120, we believe that it continues to be a promising treatment option for cancer patients, and we will continue to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. (
  • In extension trials of relapsing MS patients, Ocrevus was seen to reduce relapses even further than in the original Phase 3 studies. (
  • And analyses of both primary progressive and relapsing patients showed that the safety profile was consistent with that seen in the original clinical trials. (
  • This illustrates that the imbalance in breast cancer cases is, in part, caused by the unusual lack of cases in the trials' control groups - a point Genentech refers to when noting that cancer cases within treated patients were "within epidemiological [general population] reports. (
  • And a Phase 3 clinical trial of MedDay 's high-dose biotin MD1003 was recently launched to confirm earlier positive findings in progressive MS. Meanwhile, it is becoming clearer that stem cell transplant approaches are not benefitting progressing patients. (
  • In a randomized open-label phase II clinical trial (START-R) presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (abstract 6507), the oral multitargeted kinase inhibitor dasatinib achieved major cytogenetic responses in 35% of patients with chronic myeloid leukemia (CML) in chronic phase who had resistance or intolerance to imatinib (Gleevec) (aee also report on page 1 on FDA approval of dasatinib). (
  • About 16% of patients with chronic phase CML who receive imatinib as initial therapy have a relapse or progression within 42 months, he said, and roughly 14% of patients do not achieve a major cytogenetic response after taking the drug for a year at the 400 mg daily dose. (
  • VERNON HILLS, Ill. -- Immtech International, Inc. announced today that it has completed the initial pilot stage of the Phase IIa human clinical trial of its first oral drug candidate DB289 to treat malaria patients in Thailand. (
  • The trial results demonstrated that DB289 was safe to administer and was efficacious in the patients tested. (
  • Immtech plans to reevaluate these Phase IIa patients again in 60 days to test for any reoccurrence of the disease and any trace of parasite. (
  • A second stage of the clinical trial to treat malaria patients infected with P. falciparum, the most deadly and drug resistant form of malaria, has commenced and patient enrollment is on schedule. (
  • CHMP/EWP/83561/05: Clinical trials in small populations (EMA) addresses problems associated with clinical trials when there are limited numbers of patients available to study. (
  • Each application will propose one Phase II interventional trial that will most likely use physiological or biochemical rather than clinical endpoints along with at least one smaller basic ancillary research study that is tightly related to the clinical question. (
  • The decision is based on recommendations by an independent data monitoring committee (IDMC) which concluded that both the AMARANTH trial, in early Alzheimer's disease, and the DAYBREAK-ALZ trial, in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints upon completion and therefore should be stopped for futility. (
  • Merck said that its hepatitis C drug boceprevir hit its primary endpoints in two Phase III studies and will file for an approval of the potential blockbuster by the end of this year. (
  • Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. (
  • see also the Small populations / rare diseases section FDA: Clinical trial endpoints for the approval of cancer drugs and biologics provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. (
  • Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. (
  • The purpose of this FOA is to solicit research applications to conduct Phase II clinical therapeutic trials that have the potential to advance development of novel therapies for a lung disease or a cardiopulmonary disorder of sleep. (
  • The research work provides details of active therapeutic candidates in different phases including discovery, research, pre-clinical, phase I, Phase II, Phase III and pre-registration phases. (
  • Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. (
  • Harald Arne Bergan at Institute of Clinical Medicine will give a trial lecture on the given topic: "Therapeutic hypothermia in the post-resuscitation phase - What is the evidence on effects on brain damage from animal models? (
  • To understand the role of medical input in the selection of potentially therapeutic molecules and their subsequent clinical profiling. (
  • OBJECTIVE: To evaluate the personality characteristics of a group of participants in Phase 1 studies and to study the relation between the personality traits and the adverse events during participation. (
  • METHODS: Study population consisted of 139 healthy volunteers to Phase 1 studies. (
  • Already, over 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom the screening of at least 22 people is underway, said Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study. (
  • A phase II clinical trial of a COVID-19 vaccine candidate, conducted in China, has found that it is safe and induces an immune response, a study published in The Lancet says. (
  • A Maryland-based COVID-19 vaccine producer is expanding its late-stage Phase 3 clinical trial study to include children ages 12 to 17. (
  • This Phase 2, randomized, double-blind, parallel-group, placebo-controlled, multi-dose study is expected to be conducted at multiple centers in the United States. (
  • We are disappointed that this clinical study was futile despite the survival benefit of ASN100 as compared to placebo observed in preclinical models of pneumonia," Dr. Russo said. (
  • This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. (
  • Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study. (
  • Participation in any other investigational drug study within 1 month prior to randomization into this trial. (
  • Also standing study sections may not include clinical expertise relevant to new cell therapies. (
  • During the second phase of study, Antria plans to incorporate a larger participant group and is set to begin enrollment within the next 90 days in Gainesville, Fla. (
  • In addition, each application must include at least one basic research ancillary study tightly related to the clinical question. (
  • It is aninternational, multicenter, randomized, double-blind study involving up to 700individuals with advanced stage NSCLC, and will be conducted at approximately90 clinical sites in the U.S., Canada, India, and Europe. (
  • A second,investigator-initiated phase II study supported these results. (
  • In medical research, you see something like this once in a lifetime,"said John Nemunaitis, M.D., executive director at the Mary Crowley MedicalResearch Center in Dallas, TX and principal investigator of both the Phase IILucanix(R) study and the investigator-initiated Phase II trial. (
  • A total of 31 subjects were enrolled in the completed Phase I clinical study. (
  • The comparative Phase II trial with NXL103 is a prospective, multicenter, investigator-blinded, two-arm, parallel group study carried out in adults, either in hospital or as outpatients, with ABSSSI. (
  • The primary endpoint of the study is the clinical outcome in the clinically evaluable population at the Test of Cure (TOC) visit (7 days post-therapy). (
  • We are grateful for the contributions of the study participants and their families and encourage them to consider other Alzheimer's disease clinical trials. (
  • Original Keywords: Epeius Biotechnologies Corporation, Rexin-G, Phase I Study Epeius Biotechnologies Corp. (
  • For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit . (
  • Statistical areas of study include clinical trials, experimental design, categorical and longitudinal data analysis, and survival analysis . (
  • Fujifilm will continue the study to further evaluate tolerability and efficacies with higher doses at MD Anderson Cancer Center and proceed to early Phase IIa study. (
  • The 2019 pipeline study on Drug Addiction pipeline is a comprehensive research on the drug candidates across different phases. (
  • This research study evaluates each of the pipeline products in terms of their current status, regulatory progress and expected phase completion date. (
  • After successful completion of the preclinical animal studies and obtaining regulatory clearance for human studies, Hilleman Laboratories had initiated a clinical study in April 2016, to establish proof-of-concept for its heat stable Rotavirus vaccine. (
  • MENAFN - PR Newswire) LUND, Sweden, 4 July 2019 /PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX:NEVPF ) today announced that the company has initiated the second part in its ongoing Phase Ia/b clinical study with KL1333, NeuroVive's candidate drug for chronic treatment of genetic mitochondrial diseases, following successful completion of the first part. (
  • NeuroVive has now initiated the repeated dosing of healthy volunteers in the second part of itsPhase Ia/b clinical study of KL1333. (
  • We are truly excited about the data from the first cohort in our clinical study with KL1333. (
  • The drug properties and safety data observed are reassuring and promising as we now proceed into the second part of the study," said Magnus Hansson, Chief Medical Officer and Vice President Preclinical and Clinical Development at NeuroVive. (
  • Today's results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir's benefit to previously released study results. (
  • The National Institute of Allergy and Infectious Diseases' placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes. (
  • The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT). (
  • The value and purpose of a Phase IV clinical study is to increase the knowledge surrounding a new drug, tracking side effects, exploring new uses for the therapy as well as garnering a full understanding of the capability and uses of the drug. (
  • This study is about to enter active enrollment for the feasibility phase. (
  • What is somewhat strange about the data for cancers, particularly breast cancer, was the lack of any [breast cancer] cases in the placebo arm (PPMS study) or interferon beta treated arm ( RRMS studies) in the publications [of the clinical trial data]. (
  • CLINICAL RELEVANCE: The results of this study can inform appropriate athlete and field management practices. (
  • Imatinib 400 mg daily is certainly frontline medical therapy for chronic phase CML,' said Neil P. Shah, MD, PhD. At the time of the study, Dr. Shah was with the UCLA School of Medicine and now is with the University of California, San Francisco. (
  • Immtech plans to release a summary of the P. vivax and P. falciparum clinical trial results at the end of the study. (
  • To understand basic trial methodologies, study execution, monitoring and evaluation processes. (
  • the criteria for study placement and their cost, as well as the concept of "go no go" clinical decision for the molecule. (
  • This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population. (
  • 2. One pivotal study (EMA) provides guidance on two topics: the use of meta-analysis and the use of only a single pivotal study in phase III clinical development. (
  • SOTIO's robust clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, a platform to streamline personalized active immune cell therapies and a new generation of potent and stable antibody-drug conjugates (ADCs). (
  • Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. (
  • This book provides a comprehensive summary of common controversial issues frequently encountered in oncology trials. (
  • American Society of Clinical Oncology educational book. (
  • The results of the trial were presented at this year's American Society of Clinical Oncology (ASCO) which was held June 3-7 at Memphis, Tennessee. (
  • It's been a great opportunity and a great learning experience for me as we look at the role of updating generic labels in oncology," said Harvey, director of the Phase I Clinical Trials Program atthe Winship Cancer Institute of Emory University. (
  • Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions. (
  • The company is a Contract Research Organization (CRO) focusing on early-phase oncology drug development in solid tumors and hematologic malignancies. (
  • Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community online and in print. (
  • Ryvu Therapeutics is a clinical stage drug discovery and development company developing novel small molecule therapies that address emerging targets in oncology. (
  • As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. (
  • When asked about - in his view - the most promising of these studies, Lisak specifically mentioned those looking at three drugs: the recently approved Ocrevus ( ocrelizumab ), the investigational drug siponimod , and trials on high-dose biotin (like MD1003 ). (
  • Preclinical studies have provided new strategies but to advance the field, the relevant scientific and medical questions must be addressed through clinical investigation. (
  • Bayesian Designs for Phase I-II Clinical Trials describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. (
  • Speaking on the results Dr. Tarun Sharma, Director R&D at Hilleman Labs said,"The Hillchol" Phase I/II clinical trial results support the Hikojima vaccine design and mirrors the impressive results achieved in preclinical studies. (
  • Clinical trials , preclinical studies, basic research, and health interventions were among the May meeting's focus. (
  • Arsanis expects to advance ASN500 into Phase I clinical trials in 2019, Dr. Russo added. (
  • Moderna and the National Institutes of Allergy and Infectious Diseases have initiated a phase 3 trial evaluating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19). (
  • Last year, Roche tried and failed last year to advance another IL-13 inhibitor indicated for asthma, lebrikizumab, acknowledging disappointing results from two Phase III trials in February 2016. (
  • An Update from AB Science on this trial came out in April 2016: To read that update, click here. (
  • Funded jointly by a SickKids Research Foundation grant and SISU Inc., this trial ceased in 2016. (
  • 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. (
  • Professor Makuch's primary research interests involve methodologic issues in the design, conduct, and analysis of clinical studies. (
  • He has been closely involved in the design, conduct, and analysis of cancer clinical trials and other research projects in cancer throughout his career. (
  • Conflicts of interests have long been recognized as potential sources of influence in the conduct and reporting of clinical trials. (
  • To promote this endeavor, applications that include clinical protocols and investigators will be encouraged to apply for dedicated NHLBI cell therapy resources to help them in the planning and/or conduct of the clinical trial. (
  • This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, solicits grant applications from institutions/organizations to conduct proof-of- concept Phase II clinical trials that test a novel intervention for a lung disease or a cardiopulmonary disorder from sleep that has the potential to significantly change clinical management. (
  • Why Conduct Phase I-II Trials? (
  • Introduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. (
  • These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. (
  • Clinical considerations during preparation and conduct of first clinical trials in humans. (
  • Focus group discussions were conducted to assess factors that might impact participation of subgroups in Chennai for future HIV vaccine trials. (
  • Larger, prospective studies of markers are needed to assess their clinical value. (
  • The trial aimed to assess clinical status through a 7-point ordinal score at day 11, including hospital discharge, increasing levels of oxygen, ventilatory support, and death. (
  • ICH E1: Population exposure: the extent of population exposure to assess clinical safety presents an accepted set of principles for the safety evaluation of drugs intended for the long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening diseases. (
  • Find here all the information related to anti-cancer agents as described in the ESMO Handbook on Clinical Pharmacology of Anti-Cancer Agents. (
  • Junior or new staff of clinical pharmacology and clinical research departments. (
  • New 2018 ESMO Clinical Practice Guidelines now online! (
  • It mainly focuses on confirmatory randomised trials. (
  • EMA/CHMP/539146/2013: Investigation of subgroups in confirmatory clinical trials (EMA) provides guidance for assessors in European regulatory agencies on assessment of subgroup analyses in confirmatory clinical trials. (
  • Clinical trials are invaluable in testing new treatments, drugs and technologies. (
  • Approximately 70% of drugs or treatments tested in Phase I trials proceed to the next phase. (
  • Approximately 33% of drugs and treatments proceed to the next phase. (
  • Phase III compares standard (proven) drugs or treatments or placebos (no treatment) with the drugs or treatments that appeared to be effective in the Phase II studies. (
  • Approximately 25-30% of drugs and treatments will clear this phase. (
  • The company advances drugs for rare diseases through clinical development into the market, with or without partners. (
  • As at any MS conference, plenty of attention was given to clinical trials of potential new therapies, as well as trials gathering more information about already approved drugs. (
  • This trial is being conducted at a hospital clinic in Thailand that is experienced in evaluating new malaria drugs. (
  • Investigators with preclinical findings have found that the standard NIH grant mechanism for hypothesis-driven basic research may not be suitable for clinical questions. (
  • And basic research investigators may lack the clinical trial expertise needed to address regulatory issues, early-phase clinical trial design, trial management, or statistical issues. (
  • The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-15-025 ). (
  • But investigators in these two new trials also noted a red flag. (
  • With the current advances in regenerative medicine, many investigators will for the first time be approaching the U.S. Food and Drug Administration (FDA) with the desire to evaluate their innovative products in clinical trials. (
  • To become familiar with common challenges and key issues effecting trial designs and their execution in different countries and difficult investigators. (
  • This FOA issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, encourages Research Project Grant (R01) applications from institutions and organizations for the purpose of supporting early-phase clinical trials- i.e ., first-in-human, phase I, or phase II trials-to evaluate innovative and novel cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantations. (
  • This FOA provides a specific opportunityfor the submission of early-phase clinical trials for novel cell therapies to treat blood diseases and/or to improve the outcome of hematopoietic stem cell transplantation. (
  • It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. (
  • Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. (
  • This series focuses on product development to enable initiation of early-phase clinical trials. (
  • In the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial, Aubagio 14 mg significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo in people with RRMS. (
  • In the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE sclerosis) trial, Aubagio 14 mg significantly reduced the annualized relapse rate and slowed disability progression sustained for 12 weeks was statistically significantly reduced versus placebo in people with RRMS. (
  • It is important to note that masitinib is also in a large Phase 2b/3 clinical trial for Multiple Sclerosis. (
  • The committee recommended that trial enrollment be discontinued. (
  • This trial was a topic of discussion on the Triple Positive thread, I looked into the trial itself, and went through the enrollment screening and was accepted. (
  • I enrolled in the summer of 2012 right after finishing Herceptin, the enrollment criteria specified starting the trial within 6 months from that point. (
  • Thermal ablative therapies used in clinical practice to date include Radiofrequency Ablation (RFA), Microwave Ablation (MWA) and Cryoablation This article will focus on the advantages and limitations of thermal ablative therapy and investigates the potential of a relatively new treatment modality, Electrochemotherapy (ECT), as a novel treatment for lung cancer. (
  • A number of issues have been seen as roadblocks hindering the clinical development of new cell therapies. (
  • Basic researchers that may lack clinical experience are strongly encouraged to ask for assistance from three NHLBI resource programs: the Production Assistance for Cellular Therapies or PACT, the Gene Therapy Resource Program or GTRP, and/or the Science Moving towards Research Translation and Therapy or SMARTT. (
  • 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. (
  • Although the treatments have been well tested in the lab prior to the trial, there may still be significant risk. (
  • 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. (
  • Some of these areas include clinical trials for treatments and vaccines, global screening data, vulnerable and at-risk populations, identity provenance and consent, privacy-preserving location tracking, and supply chain optimization for ventilators and other vital medical supplies. (
  • Although definitive Phase III trials will not be supported, the proposed studies must provide proof of concept for a novel intervention that has high potential for modifying current treatments and could be disease modifying. (
  • Design and sample size considerations for Phase IV studies is another active research area, in which a new class of hybrid designs has been proposed for scientific and regulatory purposes. (
  • Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. (
  • Clinical research tools: Such tools would include those that are developed for clinical research use that do not require any federal regulatory approval, but still require extensive development in order to demonstrate validity in a diverse population. (
  • For such intricate and resource-intensive products, a detailed understanding of the regulatory process is pivotal to ensure that the transition from discovery to clinical trials is as uneventful as possible. (
  • These tutorials, CDRH Learn and OCTGT Learn , are designed to reach a broad audience in a personalized manner, covering regulatory topics that range from premarket to postmarket aspects of product development under the auspices of these two centers. (
  • CDRH Learn presents online video tutorials in English, Spanish, or Chinese and includes topics such as "Overview of Regulatory Requirements: Medical Devices" and "Investigational Device Exemption Process-IDE. (
  • An IDE is a required regulatory submission needed to obtain FDA permission to initiate a clinical trial for a medical device. (
  • An IND is a required regulatory submission needed to obtain FDA permission in order to initiate a clinical trial for an investigational pharmaceutical agent. (
  • This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. (
  • The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. (
  • This conference will address the key challenges associated with conducting a phase iv trial and the various methods and opportunities available for addressing these obstacles. (
  • This concept includes phase II studies conducted in both the U.S. and in other countries. (
  • Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. (
  • Phase 3 studies of melanoma usually exclu. (
  • We review here the fundamental requirements of clinical studies conducted under an exploratory IND and address some common misconceptions regarding oncologic phase 0 trials. (
  • Phase III studies look for a treatment that will provide a longer life expectancy, better quality of life, fewer side effects, and/or a lowered chance of the condition returning. (
  • Phase IV studies are done after a drug or treatment has been approved by the FDA and marketed. (
  • Early clinical studies-first-in-human, phase I, or phase II trials--are required to address these scientific and mechanistic questions and to move the field forward. (
  • The double-blind, placebo-controlled trial, which was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), confirms MDMA's potential. (
  • In addition to NXL103, Novexel is currently conducting two Phase II studies with NXL104 in combination with the cephalosporin antibiotic ceftazidime (CAZ/104) for serious Gram-negative infections. (
  • KL1333 is currently being evaluated in clinical phase I studies and has been granted orphan drug designation in both the United States and Europe. (
  • The second clinical program of Ryvu is SEL24(MEN1703), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia. (
  • This systematic review identified 87 randomized controlled trials assessing the effect of information technology on various aspects of medication safety, including studies of computerized provider order entry . (
  • Although processes of care consistently improved, few studies demonstrated improvement in clinical outcomes. (
  • The United States Food and Drug Administration (FDA) approved the export of DB289 for use in the trial, and Thailand's National Institute Review Board, a governmental organization with oversight authority of all new drug studies, approved the DB289 clinical trial protocols. (
  • SO-C101 is an IL-15 superagonist currently being investigated in a Phase 1 trial for the treatment of advanced solid tumors. (
  • RVU120 (SEL120) is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase Ib clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. (
  • Traditional chemotherapy for stage IV NSCLC still yieldsdisappointing results, and my hope is that this trial will improve thenatural history of the disease. (
  • Recently completed phase 2 and 3 trials have investigated topics such as intraoperative imaging, immunotherapy and chemotherapy combinations for platinum-resistant TP53-mutated epithelial cancers. (
  • We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. (
  • In 2003, Rexin-G gained FDA approval as an Orphan Drug based on clinical demonstrations of the medical utility of Rexin-G as an effective treatment for pancreatic cancer. (
  • Further, current phase of development, mechanism of drug action, special designations such as orphan drug status, fast track designation, grants awarded, etc are presented for all Drug Addiction drug candidates. (
  • Conflicts of Interest and Outcomes of Cardiovascular Trials. (
  • We now have 3 randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. (
  • The exploratory IND supports the performance of first-in-human testing of new investigational agents at subtherapeutic doses based on reduced manufacturing and toxicologic requirements, allowing the demonstration of drug-target effects and assessment of pharmacokinetic-pharmacodynamic relationships in humans earlier in clinical development. (
  • Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. (
  • I am currently working in two main areas: identifying novel biomarkers for diagnosis and treatment monitoring of TB, and translating evidence-based strategies for diagnostic evaluation of TB into routine clinical and public health practice using implementation science. (
  • ICH E6(R2): Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. (
  • FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. (
  • This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. (
  • As the world is scrambling to develop a COVID-19 vaccine, Principal Investigator of vaccine trial team at Rohtak PGI Doctor Savita Verma inf. (
  • WHAT THE READER WILL GAIN: This review provides the reader with an understanding of the mechanism of action, immunology, pharmacokinetics and clinical activity of this agent. (
  • The phase-1 human clinical trials of the two COVID-19 vaccine candidates, developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research and Zydus Cadila Ltd, have been completed and the trials have moved to phase 2, ICMR Director General Balram Bhargava said last Tuesday. (
  • Hear about the EVERREST Trial from the lead author herself - a six million euro research trial. (
  • The purpose of this FOA is to encourage applications for renewals of existing Phase II grants which are supporting research and development of such technologies. (
  • The results of the Phase 3 clinical trial, which are consistent with earlier research , mean that MDMA, which was banned in 1985, is on track to be approved as a prescription drug by the Food and Drug Administration (FDA) as soon as 2023 . (
  • This Funding Opportunity Announcement (FOA) solicits SBIR grant applications from SBCs to support later stage research and development (referred to as Phase IIB) for projects that were previously funded under SBIR or STTR Phase II awards from any Federal agency. (
  • The main objective in Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. (
  • AAP welcomes the submission of original works including peer-reviewed original research and clinical trial results. (
  • Published material includes peer-reviewed original research, clinical trials and review articles. (
  • The IBI302 Phase I research has shown good safety and tolerability with promising effect. (
  • The results presented by the current Phase I clinical trial have brought us greater confidence in the next phase of IBI302 research and development. (
  • The trial, which is the first to be implemented under Operation Warp Speed , is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US. (
  • It was agreed that Lilly would lead clinical development, working with researchers from AstraZeneca's Research and Development Team, while AstraZeneca would be responsible for manufacturing. (
  • The clinical trials were conducted in partnership with the International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh. (
  • Any college graduates who are contemplating careers in clinical research involving the bio-pharma industry. (
  • Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. (
  • The trial was designed to detect a 50% reduction in the occurrence of S. aureus pneumonia in the ASN100 arm when compared to placebo, Arsanis said. (
  • In one double blind placebo controlled trial conducted at a South Africa AIDS clinic, one of Dr. Swanepoel's oleander extracts was found to be 100% effective in reversing HIV symptoms and low white blood cell counts. (
  • Treatment with lenabasum failed to outperform a placebo when given as an add-on to standard immunosuppressants in adults with dcSSc, top-line data from a Phase 3 trial show. (
  • In clinical trials, Aubagio significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo. (
  • and three-armed trials with the test product, an active comparator and placebo. (
  • True, it has received fast-track status from the FDA for clinical trials in CLL but final approval to market the drug will depend on the success of the latest Phase-III clinical trial that has been launched. (
  • This is a single agent trial - the only drug given is HuMax-CD20. (
  • Provention Bio, Inc. PRVB, -4.93% is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease. (
  • Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA)'s recent exploratory Investigational New Drug (IND) guidance, are intended to expedite the clinical evaluation of new molecular entities. (
  • BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to (
  • The primary purpose of a Phase I trial is to evaluate the safety of a new drug or treatment. (
  • There are generally no conclusions about how well a drug works in Phase I trials. (
  • If the drug or treatment appears to be safe, it moves to Phase II. (
  • Detailed insights into Western Equine Encephalitis pipeline development, current status, companies, drug profiles and Western Equine Encephalitis preclinical and clinical trials are included. (
  • It was recently announced via press release from AB Sciences that their drug masitinib will continue to be trialed in ALS. (
  • Trial health directors can request special reports on topics such as: maternal and child health, immunization, prescription drug use, tobacco use, hypertension, obesity, and domestic violence. (
  • Until a few days ago, Carfilzomib was a drug in Phase III clinical trials not expected to be approved for at least another six months to a year. (
  • However, challenges of completing clinical trials on schedules and limited financial support are holding some of the Drug Addiction pipeline companies from advancing their products into Phase 3 or Phase 4. (
  • Click on "Drug Interventions" and page through listings to find clinical trials specific to HBV and the selected drug, such as entecavir, tenofovir or others. (
  • Topics range from "IND [Investigational New Drug] Basics in OCTGT" to "Preclinical Considerations for Products Regulated in OCTGT. (
  • Participants will be introduced to major clinical steps and considerations in the new drug development process. (
  • Pre-clinical, business, legal and marketing professionals who wish to become familiar with the clinical drug development process and the interpretation of clinical data. (
  • Potential clinical drug/drug interactions. (
  • Clinical Trials, Phase II as Topic" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus, MeSH (Medical Subject Headings) . (
  • Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. (
  • A Phase I cinical trial is the most experimental phase of clinical trials. (
  • Dr. Cohen's training is in epidemiology and clinical medicine, and his work includes mathematical modeling, fieldwork, and analysis of. (
  • MSc Quirino Puzo at Institute of Clinical Medicine will give a trial lecture on the given topic: "The global epidemiology and social determinants of suicide, with particular focus on Norway. (
  • The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13). (
  • The primary endpoint of the trial was change from baseline on ADAS-Cog13. (
  • 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. (
  • It highlights the key issues involved when sponsors include data monitoring committees as a part of their trial management. (
  • FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees. (
  • This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data andSafety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. (
  • Please find clinical trials at HSS listed by the following topics or view the full directory . (
  • SAN DIEGO, Aug. 21 NovaRx Corporation announced today thatthe company initiated its pivotal Phase III clinical trial of Lucanix(R)(belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer(NSCLC). (
  • We want you to take advantage of everything Clinical Advisor has to offer. (
  • Provention's diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies. (
  • Cytune Pharma is responsible for the clinical development of SO-C101 and SOTIO is a sponsor of the Phase 1 clinical trial. (
  • en] This review article describes the identification of the tyrosine kinase BCR/ABL as the hallmark of chronic myeloid leukemias (CML) as well as the development of a specific inhibitor of this tyrosine kinase, the STI571 (Glivec, imatinib mesylate). (
  • Yet, the development of medical biotechnology products is often impeded by a significant funding gap, known as the 'Valley of Death,' between the end of the SBIR or STTR Phase II award and the commercialization stage. (
  • Accordingly, proposed projects may address preclinical and/or clinical stages of development (including clinical trials) that are essential steps for such approvals. (
  • PARIS, November 6 /PRNewswire/ -- Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces today that its most advanced oral antibacterial NXL103 (flopristin/linopristin), has started a Phase II clinical trial in adults with acute bacterial skin and skin structure infections (ABSSSI). (
  • It is in clinical development stage intended to document the use for chronic oral treatment in primary genetic mitochondrial disorders such as MELAS, KSS, PEO, Pearson and MERRF. (
  • Economic return of clinical trials performed under the pediatric exclusivity program. (
  • Given the profound and sometimes clinical levels of distress that surrogates (i.e., parents or legal guardians) of children in pediatric intensive care units (PICU) experience [ 15 ], it is important to understand what factors may be influencing the decision making process beyond the informed consent process. (
  • FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. (
  • And for statisticians involved in the design of cancer trials, the diverse options of design and sample size calculations are well covered. (
  • Purpose The primary purpose of a Phase II trial is to determine the effectiveness of a treatment and to further evaluate its safety. (
  • The favorable results for improvement in clinical status through the 10-day treatment course of remdesivir versus standard of care approached but did not reach statistical significance. (
  • We anticipate initiating the second Phase 2 trial and reporting topline results from the first Phase 2 clinical trial during the second half of 2015. (
  • The pharma giant announced topline results from the two trials, STRATOS 2 ( NCT02194699 ) and TROPOS ( NCT02281357 ). (
  • The continual reassessment method (CRM) was modified for use in phase I trials conducted through the New Approaches to Brain Tumor Therapy (NABTT) Consortium. (
  • History or clinical features such as impaired downward gaze, prominent axial rigidity, gait initiation failure, autonomic dysfunction, etc. consistent with an atypical parkinsonism syndrome. (
  • Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a phase 3 clinical trial," said NIAID Director Anthony S. Fauci, MD. (
  • The healthcare and life sciences expert volunteers serving as mentors will help software developers understand key topic areas in those phases. (
  • The trial is expected to enroll approximately 30,000 adult volunteers. (
  • It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes. (
  • Participants expressed an intense interest in future HIV vaccine trials. (
  • A complete diagnostic evaluation should include a newborn screening, a sweat chloride test, a genetic or carrier test, and a clinical evaluation at a CF Foundation-accredited care center. (
  • At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. (
  • We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. (
  • Companies quickly adapting to the new technologies both independently and through collaborations and advancing their pipeline candidates to advanced phases will evolve as top performers. (
  • Effect of socioeconomic status as measured by education level on survival in breast cancer clinical trials. (
  • The trial wasdesigned to show a statistically significant improvement in overall survival(p (