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 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.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about studies 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.
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.
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.
Works about clinical trials 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 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.
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.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
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.
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 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.
Period after successful treatment in which there is no appearance of the symptoms or effects of the 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.
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.
Elements of limited time intervals, contributing to particular results or situations.
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.
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.
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.
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.
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.
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.
Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.
A 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.
Tumors or cancer of the LUNG.
Earlier than planned termination of clinical trials.
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.
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.
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
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.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
A 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.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
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)
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.
Tumors or cancer of the human BREAST.
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 giving of drugs, chemicals, or other substances by mouth.
Therapy with two or more separate preparations given for a combined effect.
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.
The relationship between the dose of an administered drug and the response of the organism to the drug.
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)
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 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.
Antitumor alkaloid isolated from Vinca rosea. (Merck, 11th ed.)
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.
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)
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.
A publication issued at stated, more or less regular, intervals.
An organoplatinum compound that possesses antineoplastic activity.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
A subspecialty of internal medicine concerned with the study of neoplasms.
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.
The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.
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.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.
Antibodies produced by a single clone of cells.
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.
Antimetabolites that are useful in cancer chemotherapy.
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.
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.
A pattern of gastrointestinal muscle contraction and depolarizing myoelectric activity that moves from the stomach to the ILEOCECAL VALVE at regular frequency during the interdigestive period. The complex and its accompanying motor activity periodically cleanse the bowel of interdigestive secretion and debris in preparation for the next meal.
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.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
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)
Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).
A 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.
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.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
The return of a sign, symptom, or disease after a remission.
Organic compounds which contain platinum as an integral part of the molecule.
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.
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.
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.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
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.
An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
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.
Voluntary cooperation of the patient in following a prescribed regimen.
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.
An antitumor alkaloid isolated from VINCA ROSEA. (Merck, 11th ed.)
An antineoplastic antimetabolite with immunosuppressant properties. It is an inhibitor of TETRAHYDROFOLATE DEHYDROGENASE and prevents the formation of tetrahydrofolate, necessary for synthesis of thymidylate, an essential component of DNA.
The teaching or training of patients concerning their own health needs.
Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity.
Activities performed to identify concepts and aspects of published information and research reports.
Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy 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.
Therapeutic act or process that initiates a response to a complete or partial remission level.
A decrease in the number of NEUTROPHILS found in the blood.
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.
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.
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.
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.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
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.
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
A malignant epithelial tumor with a glandular organization.
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.
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.
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.
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.
Tumors or cancer of the PROSTATE.
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)
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.
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
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.
Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.
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.
Financial support of research activities.
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.
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
Agents and endogenous substances that antagonize or inhibit the development of new blood vessels.
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.
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)
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.
Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079)
The forcible expulsion of the contents of the STOMACH through the MOUTH.
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
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)
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
A plasma alpha 2 glycoprotein that accounts for the major antithrombin activity of normal plasma and also inhibits several other enzymes. It is a member of the serpin superfamily.
An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
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.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Patient involvement in the decision-making process in matters pertaining to health.
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.
A DNA-dependent RNA polymerase present in bacterial, plant, and animal cells. It functions in the nucleoplasmic structure where it transcribes DNA into RNA. It has specific requirements for cations and salt and has shown an intermediate sensitivity to alpha-amanitin in comparison to RNA polymerase I and II. EC
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
An antineoplastic agent. It has significant activity against melanomas. (from Martindale, The Extra Pharmacopoeia, 31st ed, p564)
Societies whose membership is limited to physicians.
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.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
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.
Molecular products metabolized and secreted by neoplastic tissue and characterized biochemically in cells or body fluids. They are indicators of tumor stage and grade as well as useful for monitoring responses to treatment and predicting recurrence. Many chemical groups are represented including hormones, antigens, amino and nucleic acids, enzymes, polyamines, and specific cell membrane proteins and lipids.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
Azoles of one NITROGEN and two double bonds that have aromatic chemical properties.
Disease having a short and relatively severe course.
One of the type I interferons produced by peripheral blood leukocytes or lymphoblastoid cells. In addition to antiviral activity, it activates NATURAL KILLER CELLS and B-LYMPHOCYTES, and down-regulates VASCULAR ENDOTHELIAL GROWTH FACTOR expression through PI-3 KINASE and MAPK KINASES signaling pathways.
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
"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.
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.
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 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)
Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.
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.
Method of measuring performance against established standards of best practice.
An anaplastic, highly malignant, and usually bronchogenic carcinoma composed of small ovoid cells with scanty neoplasm. It is characterized by a dominant, deeply basophilic nucleus, and absent or indistinct nucleoli. (From Stedman, 25th ed; Holland et al., Cancer Medicine, 3d ed, p1286-7)
Agents that inhibit PROTEIN KINASES.
A peptide of about 22-amino acids isolated from the DUODENUM. At low pH it inhibits gastric motor activity, whereas at high pH it has a stimulating effect.
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.
Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.
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.
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.
Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin.
International organizations which provide health-related or other cooperative services.
Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.
Use of plants or herbs to treat diseases or to alleviate pain.
Care alleviating symptoms without curing the underlying disease. (Stedman, 25th ed)
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
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)
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.
Unsaturated androstanes which are substituted with one or more hydroxyl groups in any position in the ring system.
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)
Substances that reduce the growth or reproduction of BACTERIA.
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.
One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.
Treatment designed to help prevent a relapse of a disease following the successful primary treatments (INDUCTION CHEMOTHERAPY and CONSOLIDATION CHEMOTHERAPY) with a long-term low-dose drug therapy.
The total amount of radiation absorbed by tissues as a result of radiotherapy.
Vinblastine derivative with antineoplastic activity against CANCER. Major side effects are myelosuppression and neurotoxicity. Vindesine is used extensively in chemotherapy protocols (ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS).
Compounds that include the amino-N-phenylamide structure.
Resistance or diminished response of a neoplasm to an antineoplastic agent in humans, animals, or cell or tissue cultures.
Agents that prevent clotting.
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.
Injections made into a vein for therapeutic or experimental purposes.
Biologically active substances whose activities affect or play a role in the functioning of the immune system.
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Inorganic compounds which contain platinum as the central atom.
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.
Continuance of life or existence especially under adverse conditions; includes methods and philosophy of survival.
Human experimentation that is intended to benefit the subjects on whom it is performed.
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.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
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)

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. (1/960)

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)

The utilization of cytokines in stem cell mobilization strategies. (2/960)

High-dose myeloablative chemotherapy supported by peripheral blood progenitor cell (PBPC) transplant is rapidly replacing bone marrow transplant to treat a number of chemosensitive cancers. Numerous investigators have studied the relationship of CD34+ cell dose and engraftment kinetics in an effort to help define minimum and optimum target stem cell doses. A number of studies suggest that reinfusion of > or = 5 x 10(6) CD34+ PBPCs results in prompt and durable platelet engraftment. Mobilization of stem cells can be accomplished through use of chemotherapy alone, colony-stimulating factors, or a combination of the two. Strategies to improve PBPC yields include filgrastim in combination with chemotherapy or with other hematopoietic growth factors. In this paper, the advantages and disadvantages of these strategies will be discussed, and the results of a recently conducted, randomized, controlled phase 3 clinical trial in breast cancer patients receiving either SCF plus filgrastim or filgrastim alone for PBPC mobilization will be reviewed.  (+info)

Incremental costs of enrolling cancer patients in clinical trials: a population-based study. (3/960)

BACKGROUND: Payment for care provided as part of clinical research has become less predictable as a result of managed care. Because little is known at present about how entry into cancer trials affects the cost of care for cancer patients, we conducted a matched case-control comparison of the incremental medical costs attributable to participation in cancer treatment trials. METHODS: Case patients were residents of Olmsted County, MN, who entered phase II or phase III cancer treatment trials at the Mayo Clinic from 1988 through 1994. Control patients were patients who did not enter trials but who were eligible on the basis of tumor registry matching and medical record review. Sixty-one matched pairs were followed for up to 5 years after the date of trial entry for case patients or from an equivalent date for control patients. Hospital, physician, and ancillary service costs were estimated from a population-based cost database developed at the Mayo Clinic. RESULTS: Trial enrollees incurred modestly (no more than 10%) higher costs over various follow-up periods. The mean cumulative 5-year cost in 1995 inflation-adjusted U.S. dollars among trial enrollees after adjustment for censoring was $46424 compared with $44 133 for control patients. After 1 year, trial enrollee costs were $24645 compared with $23 964 for control patients. CONCLUSIONS: This study suggests that cancer chemotherapy trials may not imply budget-breaking costs. Cancer itself is a high-cost illness. Clinical protocols may add relatively little to that cost.  (+info)

Safety and tolerability of fluconazole in children. (4/960)

The safety profile of fluconazole was assessed for 562 children (ages, 0 to 17 years) comprising 323 males and 239 females. The data are derived from 12 clinical studies of fluconazole as prophylaxis or treatment for a variety of fungal infections in predominantly immunocompromised patients. Most children received multiple doses of fluconazole in the range of 1 to 12 mg/kg of body weight; a few received single doses. Administration was mainly by oral suspension or intravenous injection. Overall, 58 (10.3%) children reported 80 treatment-related side effects. The most common side effects were associated with the gastrointestinal tract (7.7%) or skin (1.2%). Self-limiting, treatment-related side effects affecting the liver and biliary system were reported in three patients (0.5%). Overall, 18 patients (3.2%) discontinued treatment due to side effects, mainly gastrointestinal symptoms. Dose and age did not appear to influence the incidence and pattern of side effects. Treatment-related laboratory abnormalities were uncommon, the most frequent being transient elevated alanine aminotransferase (4.9%), aspartate aminotransferase (2.7%), and alkaline phosphatase (2.3%) levels. Although 98.6% of patients were taking concomitant medications, no clinical or laboratory interactions were observed. The safety profile of fluconazole was compared with those of other antifungal agents, mostly oral polyenes, by using a subset of data from five controlled studies. Side effects were reported by more patients treated with fluconazole (45 of 382; 11.8%) than by those patients treated with comparable agents (25 of 381; 6.6%); vomiting and diarrhea were the most common events in both groups. The incidence and type of treatment-related laboratory abnormalities were similar for the two groups. In conclusion, fluconazole was well tolerated by the pediatric population, many of whom were suffering from severe underlying disease and were taking a variety of concurrent medications. The safety profile of fluconazole in children mirrors the excellent safety profile seen in adults.  (+info)

Use of the Barthel index and modified Rankin scale in acute stroke trials. (5/960)

BACKGROUND AND PURPOSE: The Barthel Index (BI) and the Modified Rankin Scale (MRS) are commonly used scales that measure disability or dependence in activities of daily living in stroke victims. The objective of this study was to investigate how these scales were used and interpreted in acute stroke trials. METHODS: We identified from MEDLINE the major efficacy trials with neuroprotective drugs, thrombolytic drugs, and anticoagulants in acute ischemic stroke published between January 1995 and December 1998. We selected those trials that used the BI and/or MRS as outcome parameters. RESULTS: Fifteen trials fulfilling the inclusion criteria were identified. The BI was used in 13 and the MRS in 8. In 4 trials mean and median scores of the BI were used, and in 1 trial median scores of the MRS were compared. Primary end points included the BI in 7, the MRS in 6, and both the BI and MRS in 3. With regard to the BI, a variety of sum scores between 50 and 95 were used as cutoff scores to define favorable outcome. Favorable outcome on the MRS was defined as either 3, or BI <60.  (+info)

Simulation studies of phase III clinical trials to test the efficacy of a candidate HIV-1 vaccine. (6/960)

One question of particular importance in phase III HIV vaccine trials is the choice of efficacy measure (EM) to validly and precisely estimate the true vaccinal efficacy. Traditional EMs, based on hazard rate ratio (HRR) or cumulative incidence ratio (CIR) are time-sensitive to mode of vaccine action and population heterogeneities. Through Monte-Carlo simulation, the performance of HRR and CIR based EMs are examined across different trial designs and vaccine and population characteristics. A new EM based on log-spline hazard regression (HARE) is proposed. Given that vaccinal properties (mode of action, time-lag, waning) are unknown a priori, appropriate selection of EM is problematic, and HRR and CIR can be unreliable to estimate the true maximum efficacy of candidate products. Non-random sexual mixing can exacerbate biases in HRR and CIR. HARE can offer valid estimation across different modes of vaccine action and in presence of frailty effects, contrary to its traditional counterparts. Our simulation studies highlight the weaknesses of widely used EMs while offering guidelines for trial design and suggesting new avenues for statistical analysis.  (+info)

Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress. (7/960)

PURPOSE: All cooperative group studies performed in North America for patients with extensive-stage small-cell lung cancer (SCLC) were evaluated to determine the pattern of the clinical trials and the outcome of patients over the past 20 years. PATIENTS AND METHODS: Phase III trials for patients with extensive-stage SCLC were identified through a search of the National Cancer Institute Cancer Therapy Evaluation Program database from 1972 to 1993. Patients with extensive-stage SCLC treated during a similar time interval listed in the Surveillance, Epidemiology, and End Results (SEER) database were also examined. Trends were tested in the number of trials over time, the number and sex of patients entered onto the trials, and the survival time of patients treated over time. RESULTS: Twenty-one phase III trials for patients with extensive-stage SCLC were initiated between 1972 and 1990. The median of the median survival times of patients treated on the control arms of the phase III trials initiated between 1972 and 1981 was 7.0 months; for those patients enrolled onto control arms between 1982 and 1990, the median survival time was 8.9 months (P =.001). Analysis of the SEER database of patients with extensive-stage SCLC over the same time period shows a similar 2-month prolongation in median survival time. CONCLUSION: Analysis of 21 phase III trials initiated in North America and the SEER database from 1972 to 1994 demonstrates that there has been a modest improvement in the survival time of patients with extensive-stage SCLC.  (+info)

Low-grade stage III-IV follicular lymphoma: multivariate analysis of prognostic factors in 484 patients--a study of the groupe d'Etude des lymphomes de l'Adulte. (8/960)

PURPOSE: To identify the prognostic factors that influence overall survival (OS) in patients with stage III-IV follicular lymphomas and evaluate the clinical usefulness and the prognostic value of the International Prognostic Index (IPI). PATIENTS AND METHODS: Four hundred eighty-four patients with Ann Arbor stage III-IV follicular lymphomas treated in two phase III trials from 1986 to 1995 were screened for this study. All histologic slides were reviewed by two hematopathologists. The influence of the initial parameters on survival was defined by univariate (log-rank test) and multivariate (Cox model) analyses. RESULTS: The poor prognostic factors for OS (age > 60 years, "B" symptom(s), > or = two extranodal sites, stage IV disease, tumor bulk > 7 cm, at least three nodal sites > 3 cm, liver involvement, serous effusion-compression or orbital/epidural involvement, and erythrocyte sedimentation rate > 30 mm/h) that were significant in univariate analysis were subjected to multivariate analysis. Three factors remained significant: B symptom(s) (risk ratio = 1.80), age greater than 60 years (risk ratio = 1.60), and at least three nodal sites greater than 3 cm (risk ratio = 1.71). When the IPI was applied to these patients, the score was 1, 2, 3, and 4-5 in 49%, 39%, 11%, and 2%, respectively, and it was significant for progression-free survival (P =.002) and OS (P =.0001). CONCLUSION: Three prognostic factors for poor OS were identified: B symptoms, age greater than 60 years, and at least three nodal sites greater than 3 cm. The IPI was prognostic for OS, but in this population, a very low number of patients belonged to the high-risk groups.  (+info)

Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients : Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients PR Newswire HATFIELD, England, June 27, 2012 HATFIELD, England, June 27, 2012 /PRNewswire/ -- New monotherapy options are needed as up to a third of epilepsy [1]patients remain uncontrolled Leading international journal, The Lancet
NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC).
London, UK, 26 September 2007: BTG plc (LSE: BGC), the life sciences company, today announces that its licensee, Genzyme Corporation, and Bayer Schering Pharma AG have initiated a pivotal phase III trial of Campath® (alemtuzumab) as a treatment for multiple sclerosis. This follows the announcement of 20 September that Campath® had been approved as a first-line treatment for B-cell chronic lymphocytic leukaemia.. Louise Makin, BTGs CEO, commented: We are excited by the prospects of Campath in multiple sclerosis and delighted that the pivotal phase III trials are under way. If the excellent results from the phase II trials are reproduced, patients will have a new treatment option that has the potential to be much more efficacious than any other existing treatment.. The full text of Genzymes announcement follows.. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis. Date: September 26, 2007. Genzyme Corporation ...
This pivotal phase III trial will investigate the efficacy and tolerability of elinogrel in patients with chronic coronary heart disease and acute coronary
GREER®, a leading developer and provider of allergy immunotherapy products and services, announces that data from its pivotal Phase III investigationa
St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation ST. PAUL,
Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapyNew Drug Application (NDA) submissions targeted for Q4 2021Phathom to host conference call and live webcast today, April 29, 2021 at 4:30 pm ET FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that in PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints. The trial studied vonoprazan in combination with amoxicillin and clarithromycin (
Today, Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660. These preliminary positive efficacy findings mark an important milestone, advancing RBX2660 in its clinical development program with a goal of bringing a US FDA approved therapy to patients. The clinical development program for RBX2660 is the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.. This press release features multimedia. View the full release here: RBX2660 is being developed to reduce C. diff infection recurrences, an urgent unmet need for patients and healthcare providers worldwide. Antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff recurrence.3C. diff causes nearly 30,000 deaths each year in the US and ...
Basel, 12 August 2015 Pivotal Phase II study of investigational medicine venetoclax met primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia Regulatory applications for...
... SAN DIEGO Mar... We are pleased to be initiating this pivotal Phase 3 trial of ZX002 a...,Zogenix,Initiates,Pivotal,Phase,3,Clinical,Trial,for,Novel,Formulation,of,Oral,Controlled-Release,Hydrocodone,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
agents The long-awaited results of the pivotal phase 3 trial of denosumab proved to be AS-605240 good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral nonvertebral and hip fractures compared with placebo. remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year disease progression stopped in 8 of 10 people who received the combination therapy compared with about 6 of 10 patients who were treated with methotrexate alone. Hoping to make its own inroads in the RA market Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker AS-605240 tocilizumab (Actemra). One of the studies published in evaluated difficult-to-treat patients with moderate to severe RA who had failed previous ...
Gilead Sciences, Inc. (Nasdaq:GILD) today announced full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or &#8220;boosting&#8221; agent for HIV therapy, compared to ......GILD
Aimmune announces 2018 outlook, including upcoming topline data in February from pivotal Phase 3 PALISADE trial of AR101 for peanut allergy.
- Pivotal Phase 3 Top-Line Results for Bempedoic Acid Expected in the Second and Third Quarters of 2018 -- NDA Submission for LDL-C Lowering Indication for Bempedoic Acid Planned by First Quarter 2019 - ANN ARBOR, Mich., Oct. 02, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Co...
Nachricht: AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis at the American Society for - 19.10.16 - News
FREMONT, Calif., Dec. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, December 3, at 8:00 am Eastern Time to review the results from the pivotal Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease (CKD) patients on dialysis. Tenapanor is Ardelyxs investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.. To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 8065608. Live audio of the conference call and accompanying slides will be simultaneously webcast and will be available under the Investors section of the companys website at The webcast will be archived and available for replay for 60 days following the call.. About Ardelyx, Inc. ...
Figure 3 Analysis strategies with biomarker-stratified phase III clinical trials. Freidlin, B. & Korn, E. L. ( 2013) Biomarker enrichment strategies: matching trial design to biomarker credentials Nat. Rev. Clin. Oncol. doi:10.1038/nrclinonc.2013.218. Slideshow 6861152 by chantale-scott
SAN ANTONIO and TOKYO, March 18 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. (BioNumerik) and ASKA Pharmaceutical Co., Ltd. (ASKA) today announced the results of a Phase III clinical trial of
FUJIFILM Toyama Chemical Co., Ltd. has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC ...
Trial reaches objectives of significantly reducing allergy symptom scores and anti-allergy medication use during ragweed pollen season LENOIR, N.C. June 12, 201
Top-line data from the double-blind, North American Phase III BLOOM-1 trial in 597 surgically menopausal women showed that transdermal LibiGel missed the co-primary endpoints of significantly increasing the total Read the full 293 word article
Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).
BioWorld Online is the news service of record for the biotechnology industry and is updated every business morning. BioWorld Online will keep you up to date on all of the industrys business, science and regulatory news -- mergers and collaborations, FDA hearings and results, breakthroughs in research and much more.
...Reinach Switzerland 26 October 2008 Arpida (SWX: ARPN) today presen...Iclaprim a novel antibiotic from the trusted dihydrofolate reductase ... The high efficacy rates and favorable tolerability profile of iclapri...The results presented at the ICAAC/IDSA meeting were gathered from the...,Phase,III,data,show,efficacy/safety,of,iclaprim,in,patients,with,complicated,skin,infections,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
Belgiums UCB has presented fresh data from a late-stage trial of its new rheumatoid arthritis compound Cimzia, in combination with methotrexate, which shows that the drug prevents structural damage to the joints. - News - PharmaTimes
Belgiums UCB has presented encouraging data from a late-stage trial of an extended-release version of its anti-epilepsy blockbuster Keppra. - News - PharmaTimes
Zealand Pharma A S (NASDAQ OMX ZEAL), a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce
Some fraction of phase I clinical trials will move on to the phase II, which seeks to answer the question as to whether the drug has, in fact, an apparent effect against the cancer in question (in our case pancreatic cancer). Many potential drug therapies go no further than phase II - as they show no real effect against pancreatic cancer. Successful phase II candidates move on to phase III clinical trials which seek to determine how the new therapy compares to existing standard therapies. Phase III clinical trials are the core measure of a potential new drug. Phase III clinical trials are controlled experiments whereby patients with similar characteristics are assigned to receive either the existing therapy or to receive the new therapy. After a time, the results of the arms of test are then compared. If the new agent shows similar or improved results as compared to existing therapy, (after another step or two) it is often approved for release by the FDA. There is even a phase IV to this process ...
Table of Contents Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our global pivotal Phase 3 clinical studies, our global pivotal Phase 3 bridging study for the bempedoic acid / ezetimibe combination, or our CVOT of bempedoic acid may occur, which may result in changes to clinical study protocols or additional clinical study requirements, which could result in increased costs to us and could delay our development timeline. Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our clinical studies may force us to amend clinical study protocols or the FDA or EMA may impose additional clinical study requirements. Significant amendments to our clinical study protocols may require resubmission to the FDA and/or IRBs for review and approval, which may adversely impact the cost, timing and/or successful completion of these studies. If we experience substantial delays completing or if we terminate any of our global pivotal Phase 3 ...
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 27, 2015. Macrocure Ltd. (NASDAQ:MCUR), announced results from a pivotal Phase 3 multicenter,
Roche announced today that a Phase III study investigating MabThera (rituximab) in combination with chemotherapy has shown a significant improvement in progression free survival in patients with relap...
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
We use cookies to ensure that we give you the best experience on our website. If you click Continue well assume that you are happy to receive all cookies and you wont see this message again. Click Find out more for information on how to change your cookie settings ...
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the...
BOUDRY, Switzerland--(BUSINESS WIRE)--May. 6, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the prim...
The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinsons Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process - from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinsons disease ...
Study met its primary endpoint demonstrating significant improvement in progression-free survival (PFS) with POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone (PVd) compared with bortezomib and ...
CAMBRIDGE, Mass., May 31, 2011 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), today announced that 56-week data for its lead compound, lomitapide, in a pivotal Phase III clinical trial, were consistent with the data seen in the same study at 26 weeks. The single-arm, open label trial is designed to evaluate the efficacy and long-term safety of lomitapide for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a rare and often fatal condition characterized by severely elevated levels of low-density lipoprotein cholesterol, or LDL-C, leading to life-threatening cardiovascular events. Lomitapide has been designated by FDA as an orphan drug to treat this condition. The data show that lomitapide reduced cholesterol substantially in patients with HoFH.
Therapeutic area data reported by biopharma companies on phase III trials in February 2020, including: Abbvie, Acucela, Adamas, Allecra, Alnylam, Amgen, Ampio, Arcutis, Astellas, Axsome, Bayer, Biohaven, BMS, Breath, Citius, Crescita, Eli Lilly, Exelixis, Foamix, Genentech, Genfit, Gilead, Incyte, Ionis, Janssen, Kowa, Marinus, Merck, Minerva, Myovant, Novan, Pfizer, Polyphor, Polypid, Proteostasis, PTC, Rebiotix, Sanifit, Scynexis, Servier, Takeda, Teva, Tonix, Vanda, Zynerba.
LAWRENCEVILLE, NJ -- (Marketwire) -- 05/30/12 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has reached its enrollment objective of 700 pa...
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
OCA Meets Primary Endpoint With High Statistical Significance of p , 0.0001. -Company to Conduct Conference Call and Webcast March 17, 2014 at 8:30 a.m. ET. NEW YORK, March 16, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trials primary endpoint of achieving a reduction in serum alkaline phosphatase (ALP) to , 1.67x ULN with a ≥ 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p , 0.0001 vs placebo) in an intention to treat analysis. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant ...
Novartis International AG / Phase III data shows Sandoz' proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Ceftazidime-avibactam is being developed with Astra Zeneca jointly. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the privileges to commercialize ceftazdime-avibactam in the rest of the global world.. Actavis reports excellent results from ceftazidime-avibactam Phase III studies in cIAI patients Actavis plc today confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the prospect of the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized sufferers with complicated intra-abdominal infections. Ceftazidime-avibactam includes a cephalosporin , an established treatment for significant bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor .This system appears to be more essential than those earlier described for prolonged stimulation by dopamine, as would be the case in those with ...
Update on Paroxysmal Nocturnal Hemoglobinuria (PNH) Long Term Safety Study Shows 100% Transfusion Independence Two-part pivotal Phase III study of nomacopan in pediatric.
STOCKHOLM - December 7, 2019 - Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019. Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study. These data reinforce Oncopeptides view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020.
Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting
CORAL GABLES, Fla., March 25, 2014 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, announced today that, at a recently held meeting, the independent Data Monitoring Committee (DMC) overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial.
WOCKHARDT RECEIVES ACKNOWLEDGEMENT OF ITS BREAKTHROUGH SUPERDRUG ANTIBIOTIC WCK 5222 FOR PHASE III CLINICAL TRIAL FROM US FDAIn a recent meeting between Wockhardt Research team and US FDA New Drug Antibiotic Regulatory team, US FDA agreed to abridged
Aurinia Announces Plans For Single Phase III Clinical Trial For Voclosporin In The Treatment Of Lupus Nephritis Following Successful Completion Of End Of Phase II Meeting With FDA - read this article along with other careers information, tips and advice on BioSpace
GlaxoSmithKline plc (GSK,GSK.L) announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix in preventing shingles when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant. Shingrix is a non-live, recombinant adjuvanted subunit vaccine.. The study succeeded in its primary objective by demonstrating an efficacy of 68.17%. The vaccine reduced overall complications linked to shingles episodes by 77.76%. No safety issues related to the vaccine were detected during the study. GSK said it is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan. by RTT Staff Writer. For comments and feedback: [email protected] Business News ...
TY - JOUR. T1 - Depressive distress among the spouses of terminally III cancer patients. AU - Siegel, Karolynn. AU - Karus, Daniel G.. AU - Raveis, Victoria. AU - Christ, Grace H.. AU - Mesagno, Frances P.. PY - 1996/1/1. Y1 - 1996/1/1. N2 - Bereaved spouses comprise a population at risk for psychological distress. Evidence suggests that spouses 55 years of age and younger are at increased risk of morbid outcomes, including major depressive episodes. Although the emotional impact of the sudden loss of a spouse has been well studied, less attention has been paid to the psychological impact of loss that is foreseeable, as in the case of a serious illness. In this study, data were obtained from pre-death interviews with 103 well spouses of terminally ill cancer patients. Subjects were white, 55 years of age or younger, and living with the patient and their child(ren) aged 7 to 16 years old. Depressive distress was assessed using the Brief Symptom Inventory. Fifty eight percent of males and 42% of ...
Sanofi reports that the first patient outside of the US has been treated as part of a global clinical program evaluating Sanofis and Regeneron Pharmaceuticals Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the US, all countries that have been impacted by COVID-19. Sanofi is leading trials outside the US while Regeneron is leading US trials.. This is the second multi-center, double-blind, Phase II/III trial as part of the Kevzara COVID-19 program, and the companies say that they are continuing to work with authorities around the world to secure initiation at additional sites. This follows Sanofi and Regenerons earlier announcement of the initiation of the first trial, which is US-based.. Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive ...
Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks ...
This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung
Summary: Naturally occurring mutations in the hepatitis C virus (HCV) are common and many lead to reduced efficacy of antiviral treatments. Faldaprevir* has now been shown to be effective even in patients with the common HCV Q80K variant,1 which affects an estimated 700,0002,3,4 patients in the USA alone. Faldaprevir* is being studied in combinations both with and without interferon. The EMA recently granted accelerated assessment for faldaprevir* as part of an interferon-based regimen and a decision on marketing authorisation is anticipated next year.5,6. For media outside of the US, the UK & Canada only. INGELHEIM, 16 December, 2013 - Data show that Boehringer Ingelheims second-generation protease inhibitor faldaprevir*, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus (HCV), such as the NS3 Q80K polymorphism. The Q80K mutant was detected in 23% (49/127, STARTVerso™1) and ...
M.D., Ph.D., senior vice president, global development and chief development officer at Ironwood.Pre-clinical and clinical evidence suggest that IW-3718 may offer a treatment option for the millions of patients with GERD who continue to experience frequent and bothersome symptoms such as heartburn and regurgitation despite taking PPIs. Our teams have done excellent work to rapidly initiate these trials. We are hopeful that these studies will generate data in support of a potential approval as quickly as possible. The Phase III program comprises two identical randomized, double-blind, placebo-controlled, multicenter Phase III trials that target enrolling approximately 1,320 patients total (660 in each trial) with persistent GERD who demonstrate evidence of pathological acid reflux. Eligible patients will continue to take PPIs and be randomized to placebo or IW-3718 1500 mg twice a day for eight weeks. The primary endpoint is overall heartburn responder, defined as a patient who experiences at ...
The Phase III RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir) clinical trial program has been designed to study the safety and efficacy of tipranavir (boosted with low-dose ritonavir) versus a low-dose ritonavir-boosted comparator protease inhibitor (PI) that is chosen by the patients physician on the basis of treatment history and baseline resistance testing. Study participants will all be highly treatment-experienced HIV-positive adults. Phase III of clinical development is the final stage of testing before a drug is submitted to worldwide regulatory authorities for review and consideration for marketing approval. The RESIST Program consists of two Phase III pivotal trials (RESIST 1 and RESIST 2) and two companion trials (study 1182.51 and RESIST 3) available for even more advanced patients ...
Analyses of pivotal study data of Dysport® reveal a large proportion of study patients did not require retreatment for at least 12 weeks (and at least 16 weeks for pediatric upper limb spasticity) This new analysis concluded that Dysport® is associated with a long duration of response These data form one of 26 abstracts Ipsen […]
Read about how Teva Pharmaceuticals investigational treatment for migraine prevention was able to reduce the number of migraine days per month in a recent Phase III clinical trial.
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 11, 2013. Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the
This resource center is for patients and families coping with cancer and interested in learning about clinical trials for the disease. You can find information here on how clinical trials are structured and managed, how to find and evaluate clinical trials, how eligibility to participate is determined, the ethics of conducting clinical trials, special types of clinical trials, and financial issues related to clinical trials.
Following these, two additional analyses for OS are planned: a second interim analysis and a third and final OS analysis.. With 630 patients, the SYMMETRY trial is over 95% powered to detect a statistically significant improvement in PFS. Secondary endpoints in addition to overall survival include response rate, clinical benefit rate (defined as complete response, partial response, or stable disease at 24 weeks), and duration of response. Projections and powering assumptions are based on detecting an improvement of two months in PFS (67%, hazard ratio 0.60), or three months in OS (33%, hazard ratio 0.75).. Based on our current enrollment and event rate projections, Synta expects to complete the primary endpoint analysis by the end of 2008 and file a New Drug Application (NDA) with the Food and Drug Administration (FDA) by the first half of 2009.. The SYMMETRY trial is now open for patient recruitment. For those interested in more information about the trial, please visit ...
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regenerons products, product candidates, and research and clinical programs now underway or planned, including without limitation sarilumab; ongoing regulatory obligations and oversight impacting Regenerons marketed products, research and clinical programs, and business, ...
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA™ (daclizumab high-yield process), dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS) compared to AVONEX® (interferon beta-1a).
May 19, 2004. The U.S. Food and Drug Administration has granted approval of Gemzar® (gemcitabine HCl), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer.. The FDAs approval marks the second indication in 2004 for a Lilly Oncology drug, and for Gemzar, specifically; this is the drugs third indication in the United States.. The approval of the Gemzar/Taxol combination was granted following analysis of Phase III data, which demonstrated superior treatment outcomes. Patients diagnosed with metastatic breast cancer and treated with a combination of Gemzar and Taxol experienced a significant delay in the improvement in time to disease progression of their disease and response rate compared to Taxol alone. The time to disease progression data (5.2 months vs. 2.9 months, respectively; p,0.0001) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2003. Survival results will be ...
AbbVie (NYSE: ABBV), a global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that data...
There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concurrently across a number of different biomarker-defined population-enriched cohorts: BRAF mutation; activated AKT pathway: PI3K mutation/absolute PTEN loss tumors; KRAS and NRAS mutations; and wild type at all the
October 2, 2015.. We are delighted to announce that the HiP trial is fully up and running and has dosed its 15th patient. This multi-center, randomized controlled trial is being led by Cork University Hospital and is being conducted in several centers in Europe and Canada. We expect to enroll approximately 750 babies.. About 150,000 pediatric patients, mostly newborn babies and infants, are treated for hypotension in Europe each year. Hypotension can occur as a result of any one of a number of conditions. Those conditions are often life-threatening and require urgent treatment. Currently, pediatric patients are treated with drugs that are not specifically approved for children and are supplied in a form that is appropriate for an adult.. The purpose of the trial is to further refine the optimal treatment protocols for this vulnerably population and it will lead to the development of an age-appropriate dosage form of the most commonly used drug for treating hypotension in pediatric patients. The ...
OncologyPRO is the home of ESMOs educational & scientific resources, with exclusive content for ESMO members such as ESMOs Congresses webcasts,
Bachem and ISA Pharmaceuticals B.V. today announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceuticals immunotherapeutic HPV-SLP® product. Press Release. ...
Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, Inclusive and open to diversity, innovation oriented to win together and benefit the mankind, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and ...
Motif chief executive Graham Lumsden told investors: Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilized dihydrofolate reductase inhibitor class, can become an integral part of hospital doctors life-saving treatment strategies. ...
Complement refers to a cascade of inter-related proteins that are important in defending our bodies against a wide range of bacteria. Over our lifetimes, our bodies have learned to recognize certain markers (antigens) on bacteria and developed antibodies (immunoglobulins) that are specific to each of these antigens. As soon as one of these known bacteria is seen, the antigens on the surface of the bacteria are quickly tagged by the corresponding antibody molecules circulating in our blood. The presence of these antigen-antibody pairs on the surface of the microbe are like neon advertising signs that attract complement proteins to swoop down and kill the cell. I hope you can see the parallel between this scenario and what happens when we treat a CLL patient with a man-made anti-CD20 monoclonal antibody. Here the hapless B-cell is in the role of the bacterium, the CD20 marker it carries is the antigen and the man-made monoclonal antibody drug is the synthetic immunoglobulin that mates with the ...
A group of researchers at Osaka University developed a synthetic tissue using synovium-derived mesenchymal stem cells (MSCs) for treating damaged cartilage, which had previously been incurable and had no effective therapies.
The IMbrave150 study combination immunotherapy, with the PD-L1 inhibitor atezolizumab and the VEGF inhibitor bevacizumab, has proven positive results by enhancing the potential of the immune system to combat Hepatocellular Carcinoma (HCC) among Asian patients
RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by sto
Hi i am new to this site but my husband went in with a seizure in late September of this year and before we knew it within 3 days there was a biopsy preformed and then a few days to follow he was being scheduled for a craniotomy! he is 36 and we have 3 children (12, 10 ,1) fear isnt even the world to being to describe what we both were feeling for each other and our children. We live in buffalo ny and he is now an official patient of Roswell which is not far from our house at all. he was dignaised with AA3 in his right frontal lobe they were able to remove 90% of the tumor he followed up with radiation and chemotherapy pill form and had very little to none of the side effects. He did lose his hair but thats the least of his problems and something that is very managable (bald is beautiful ) we have lucked out so far if thats even a thing with something this devastating but he is able to function 90 percent of his body and uses a cane as he had to reteach his left side to move Simultaneously ...
DARMSTADT, Germany and NEW YORK, November 28, 2017 /PRNewswire/ -- Not intended for UK-based media - Pivotal Phase III Javelin trial investigating
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC). ...
Amgen and Novartis will expand their collaboration with the Banner Alzheimers Institute by launching a new Phase II/III trial designed to assess whether the oral BACE1 inhibitor CNP520 codeveloped by the companies can prevent or delay symptoms in people at high risk for the disease
* 24-month update on Phase III data comparing Tasigna to Glivec in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase, , , , * Afinitor plus hormonal therapy stud...
Atacicept, a biologic agent that targets two B-cell factors in patients with moderate-to-severe lupus, failed to meet the primary endpoint in a yearlong phase II/III trial, researchers reported.
Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for...
... company Eli Lilly terminated further development of the compound in 2012 after it failed in phase III clinical trials. In ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... 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 ...
He contributed to Track-HD and Track-ON HD, two influential observational studies in HD, and to 26 phase I-III clinical trials ... Other topics on which he published include neuroimaging and pain. Vast majority of Landwehrmeyer's publications are devoted to ... "An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196 (PADDINGTON)". ... multicenter European phase III HD trial. This collaboration led to forming the European HD Network (EHDN) in 2003-2004, funded ...
In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ... 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 ...
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-1045. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749 ... "MERS vaccine shows promise in clinical trial, say researchers". "Developing a vaccine against Nipah virus". Sifferlin, A. ( ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ...
The group took pafuramidine, a new orally available drug for human African trypanosomiasis, through phase III clinical trials, ... Barrett also writes regularly for a variety of newspapers and magazines on topics related to science and also spanning the arts ...
The first telomerase inhibitor to enter clinical trials, it is currently[when?] 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 ... which?] Chemically, imetelstat is a synthetic conjugate consisting of three parts: GRN163, a thiophosphoramide oligonucleotide ...
Three primary tasks at this end phase include determining that the project is actually complete, evaluating "the project plan ... From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... In a good manufacturing practice regulated industry, the topic is frequently encountered by its users. Various industrial ... "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS". U.S. Food and Drug Administration. April 1999. Retrieved ...
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 ...
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 ...
... "its fast-growing portfolio of Phase I, Phase II and Phase III clinical trials." Termeer was on the board of directors of the ... Boston Globe staffer Geeta Anand wrote a book on the topic called The Cure. Crowley was profiled in The Wall Street Journal by ... Fierce Biotech covers biotechnology news including biopharma deals and clinical trials. When Prosensa was founded in 2002 in ... In 2013 ProQR's CEO Daniel de Boer, whose three-year-old son suffers from cystic fibrosis was introduced to Termeer in Boston ...
... a second round of clinical trials in Korea has begun with 10 hospitals participating. Multiple Phase 2/3 and Phase 3 clinical ... "Current Practices in Acute Blood Purification Therapy in Japan and Topics for Further Study". Contributions to Nephrology. 196 ... "Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia - Full Text View". 2020-06-05. Retrieved ... Tong, Associate Professor Steven (2020-07-23). "Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial - Full Text View". ...
A randomized phase III study in advanced non-small cell lung cancer (NSCLC)". American Society of Clinical Oncology. Archived ... Clinical Cancer Research; Clinical Trials. 6 (7): 2677-84. PMID 10914709. Archived from the original on 28 July 2009. Retrieved ... Cancer Topics - Coping with Cancer. National Cancer Institute. Archived from the original on 6 December 2008. Retrieved 1 ... A Phase III study showed benefits of maintenance use of pemetrexed for non-squamous NSCLC. Activity has been shown in malignant ...
During phase II clinical trials there was some indication of a decreased mean viral load in patients with infected human ... Topics in HIV Medicine. 13 (1): 24-44. ISSN 2161-5845. PMID 15849370. Ryder, Neil S (2007-12-01). "Discontinued drugs in 2006: ... in a phase II trial. PubChem. "Dexelvucitabine". Retrieved 2022-04-07. Hernandez-Santiago, Brenda I ... announced the decision to cease further trials and development of the drug due to an increased incidence of grade 4 ...
From 2016 to 2018, Phase III/IIIb open-label clinical trials HOPE (MTN-025) and DREAM (IPM-032) were launched to focus on the ... Physical characteristics of the ring such as size and hardness were a topic of concern amongst participants. The ease of ... Since 2017, a three-month DPV Ring option has been under clinical trial. A number of alternative intravaginal rings made by IPM ... DPV Rings were given to the former Phase III trial participants for one whole year. HOPE ended in October 2018 and DREAM ended ...
It has eight products, and as of August 2021, only Omidria is fully marketed; the others are in different trial phases. List of ... Articles with topics of unclear notability from August 2021, All articles with topics of unclear notability, Company articles ... ". "About Omeros - Clinical Studies & Company Milestones". "Pamela Palmer, M.D., Ph.D., Has Developed a New Wonder Drug for her ... with topics of unclear notability, Wikipedia articles with undisclosed paid content from January 2022, Orphaned articles from ...
This is a three-phase process that trains the client to use skills that they already have to better adapt to their current ... results of a randomized clinical trial" (PDF). Journal of Consulting and Clinical Psychology. American Psychological ... The research conducted for CBT has been a topic of sustained controversy. While some researchers write that CBT is more ... It is more the process that contains basically three phases that are used for achieving wanted goals. The Unified Protocol for ...
In the phase III clinical trials, misuse potential adverse events were reported in 3.0% with placebo, 4.1% with 15 or 20 mg ... Jacobson LH, Chen S, Mir S, Hoyer D (2016). "Orexin OX2 Receptor Antagonists as Sleep Aids". Current Topics in Behavioral ... As of October 2021, it is in phase III clinical trials for this indication. Suvorexant has been studied in the treatment of ... A phase IV clinical trial of suvorexant as an adjunct to antidepressant therapy in people with major depressive disorder and ...
Construction Law Journal Contemporary Clinical Trials Cortex Cretaceous Research Current Biology Current Opinion Current Topics ... Geochimica et Cosmochimica Acta Geoforum Gynecologic Oncology Heart Rhythm Historia Mathematica Human Immunology Icarus III-Vs ... Neurology Explorations in Economic History FEBS Letters Fire Safety Journal Fitoterapia Flight International Fluid Phase ... "Current Topics in Developmental Biology". Book Series. Elsevier. Retrieved 15 May 2013. "Home". Elsevier. "Procedia ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Be the Generation - Information on HIV Vaccine Clinical Research in 20 American Cities ... Missing or empty ,title=. (help) ...
GSK suspended Phase III clinical trials in October 2008. Informations for this group of inhibitors are quite restricted. ... Current Topics in Medicinal Chemistry, 7 (6): 579-595, doi:10.2174/156802607780091000, PMID 17352679 Cox, Jason; Harper, Bart; ... In January 2007 alogliptin was undergoing the phase III clinical trial and in October 2008 it was being reviewed by the U.S. ... In 2008 BI-1356 was undergoing phase III clinical trials; it was released as linagliptin in May 2011. X-ray crystallography has ...
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 ... Eliminating the MTH1 gene in mice results in over three times more mice developing tumors compared to a control group. The ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". U.S. National ...
... three clinical compounds: K-NK002 in Phase II trials for hematopoietic stem cell transplants in blood cancer, K-NK003 for ... "IMI Call Topics 2008". IMI-GB-018v2-24042008-CallTopics.pdf. European Commission. Archived from the original on 15 October 2009 ... as the FDA asked companies to include neurocognitive testing into their Phase III clinical trials. In 2013, Sanofi announced ... which was then in Phase I clinical trials. Aventis invested $45 million in Regeneron and made an upfront payment of $80 million ...
Results of clinical trials are also presented, such as data from a Phase II clinical trial of MT-102 in cancer-related cachexia ... Articles with topics of unclear notability from December 2016, All articles with topics of unclear notability, Company articles ... End-points in clinical trials including Patient-reported outcomes. Nutrition. Endpoint in clinical trials: strengths and ... These consensus projects aimed to facilitate the future design and performance of clinical trials in the fields of cachexia and ...
After completing Phase III clinical trials, on February 10, 2014, Gilead filed for U.S. approval of a ledipasvir/sofosbuvir ... Similar to sofosbuvir, the cost of Harvoni has been a controversial topic. It costs $1,125 per pill in the US, translating to $ ... According to clinical trials, ledipasvir/sofosbuvir has been very well tolerated with the most common side effects being ... March 3-6, 2013. Abstract 41LB. CROI 2013: Sofosbuvir + Ledipasvir + Ribavirin Combo for HCV Produces 100% Sustained Response ...
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 -". 24 January 2007. {{cite journal}}: Cite ... 553 (1-3): 163-70. doi:10.1016/j.ejphar.2006.09.027. PMID 17059817. Patel JG, Bartoszyk GD, Edwards E, Ashby CR (April 2004). " ...
Tasimelteon completed the phase III clinical trial in the United States for primary insomnia in 2010. The Food and Drug ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165.{{cite journal}}: CS1 ... TIK-301 (PD-6735, LY-156735) has been in phase II clinical trial in the United States (US) since 2002. The FDA granted TIK-301 ... Tasimelteon was developed by Vanda Pharmaceuticals and completed the phase III trial in 2010. It was approved by the FDA on ...
A phase II clinical trial is recruiting individuals to study how well nivolumab with or without varlilumab works in treating ... The neoplastic B-cells in these spaces carry the EBV virus in stage III latency (see EBV latency infections) and therefore ... Ascherio A, Munger KL (2015). "EBV and Autoimmunity". Epstein Barr Virus Volume 1. Current Topics in Microbiology and ... A phase I clinical trial is recruiting individuals to study the side effects and efficacy of CD19/CD22 chimeric antigen ...
... in the New England Journal of Medicine in 2014 detailing the results of a multi-center NIH-funded phase III clinical trial of ... The specific details of how this process occurs at the molecular and ultrastructural levels are topics of active neuroscience ... In a clinical trial, a group of severely injured patients had a 60% reduction in mortality after three days of progesterone ... However, clinical trials showed progesterone offers no significant benefit for traumatic brain injury in human patients. ...
Retrieved 21 March 2021.{{cite web}}: CS1 maint: url-status (link) "Daiichi Sankyo Initiates Phase 1/2 Clinical Trial for mRNA ... Retrieved 11 March 2021.{{cite web}}: CS1 maint: url-status (link) "Phase II / III Study of COVID-19 DNA Vaccine (AG0302- ... "Ongoing Topics - Novel Coronavirus Vaccines". Prime Minister of Japan and His Cabinet. 8 September 2021. Archived from the ... Japan Registry of Clinical Trials. Retrieved 7 May 2021.{{cite web}}: CS1 maint: url-status (link) "Safety and Immunogenicity ...
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 ... 3). Convergent synthesis gives the product as a mixture of isomers. Pimavanserin Volinanserin "Future Treatments for Depression ...
The postpartum period can be divided into three distinct stages; the initial or acute phase, six to 12 hours after childbirth; ... Unless there is some other indication, mothers can attempt a trial of labour and most are able to have a vaginal birth after C ... Clinical Obstetrics & Gynaecology. 22 (6): 1103-17. doi:10.1016/j.bpobgyn.2008.07.005. PMID 18793876. Ball H (June 2009). " ... and perinatal psychology Reproductive Health Supplies Coalition Unassisted childbirth Vernix caseosa Natural birth topics: ...
... with 953,000 vacancies in the three months to July, while unemployment fell by 4.7% in the three months to June. Fast food ... The clinical guidelines regarding the booster vaccine are to be changed for some people, such as care home workers, to allow ... "Positive trial results for Valneva Covid vaccine". BBC News. 18 October 2021. Retrieved 20 October 2021. "Covid: Is the pace of ... The UK government confirms the £20 Universal Credit top up introduced at the beginning of the pandemic will be phased out in ...
... and established a number of spin-off companies including Linear Clinical Research, an early phase-1 clinical trials facility. ... He currently reports directly to the Minister for Science, Dave Kelly, and provides independent, external advice on topics that ... In 1994 he was appointed UWA Professor of Clinical Biochemistry based at the Royal Perth Hospital, and in 2000 he became ... Home page, Harry Perkins Institute of Medical Research Linear--About us, Linear Clinical Research Brain Growth and Disease, www ...
"A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL ... In 1998, his paper on the topic showed that in people treated with capsaicin instillation, bladder biopsies were normal after ... Summerton, Duncan (November 2020). "Welcome from the Immediate Past-President". Journal of Clinical Urology. 13 (1_suppl): 2. ... Three years later, his Botox technique was presented at the 2005 BAUS Annual Scientific Meeting in Glasgow and became known as ...
... performing multiple phase 2 trials. A phase 3 trial of VLA15 was scheduled for late 2022, recruiting volunteers at test sites ... In clinical trials involving more than 10,000 people, the vaccine was found to confer protective immunity to Lyme disease in 76 ... There are three stages in the life cycle of a tick. Larva, nymph, and adult. During the nymph stage, ticks most frequently ... "CDC - Lyme Disease - NIOSH Workplace Safety and Health Topic". 3 August 2017. Archived from the original on 13 ...
"Results revealed from phase I clinical trial of the first drug to successfully inhibit the MYC gene, which drives many common ... Current Topics in Microbiology and Immunology. 258: 153-60. doi:10.1007/978-3-642-56515-1_10. ISBN 978-3-642-62568-8. PMID ... The recombinantly produced Omomyc miniprotein has been developed as a drug (OMO-103) and is currently in clinical trials. ... Clinical Oncology. 19 (1): 23-36. doi:10.1038/s41571-021-00549-2. PMID 34508258. Soucek L, Helmer-Citterich M, Sacco A, Jucker ...
The study, a phase II clinical trial designed to evaluate safety and efficacy of endovascular treatment, enrolled initially 10 ... McFarland Health Topics. ISBN 978-0-7864-8628-1. (All pages needing factual verification, Wikipedia articles needing factual ... One of the studies identified three factors contributing to patients going abroad seeking treatment: a loss of faith in the ... "Health minister rejects MS therapy trial". CBC News. 2 September 2010. Weeks C (29 June 2011). "Ottawa to fund clinical trials ...
PARP inhibitor olaparib is an approved breast/ovarian cancer drug that is undergoing clinical trials. Also in trials for CRPC ... "Positive Outcome of Interim Analysis of pivotal Alpharadin study: Primary endpoint met in Phase III ALSYMPCA study" (Press ... "Gleason Score - an overview , ScienceDirect Topics". Retrieved 2022-04-28. Epstein JI, Egevad L, Amin MB ... It is used widely in clinical practice and research settings. The major downside to the three-level system is that it does not ...
Three sessions were completed before launch (L-21, L-14 and L-8 days) and three after landing (R+0, R+2 and R+7 to R+10 days). ... In a 90-day bed rest trial, a 26% ± 7 decline in the CSA of the calf muscle was observed. This rate of decline is consistent ... More recent studies on this topic clearly suggest that the type IIx MHC, which is a faster isoform than the IIa type, is more ... However, capability to provide sufficient exercise capacity during the Martian outpost phase is essential in preparing the crew ...
A systematic review and meta-analysis of randomised clinical trials investigating antimicrobial prophylaxis or metaphylaxis ... Typically there are three approaches to dealing with Histophilus somni in a herd of cattle; mass antibiotic treatment, H. somni ... Upper respiratory tract colonization is possible through decoration of LOS with phase-variable phosphorycholine (ChoP) that ... Corbeil, Lynette B. (2015), Inzana, Thomas J. (ed.), "Histophilus somni Surface Proteins", Histophilus somni, Current Topics in ...
A randomized controlled trial". Journal of Consulting and Clinical Psychology. 75 (2): 336-343. doi:10.1037/0022-006x.75.2.336 ... There are two phases in Orem's self-care: the investigative and decision-making phase, and the production phase. Under this ... Three major barriers to care include: insurance coverage, poor access to services, and being unable to afford costs. Without ... Tooth brushing and personal hygiene can prevent oral infections.[citation needed] Health-related self-care topics include; ...
CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus ... His research on this topic has been published in The Lancet. Pivot's study represented the largest French academic study in ... Constitutional variants are not associated with HER2-positive breast cancer: results from the SIGNAL/PHARE clinical cohort. ... A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With ...
Habif, Thomas (2016). Clinical Dermatology. Elsevier. pp. 534-576. Adams, James (2013). Emergency Medicine Clinical Essentials ... Current Topics in Microbiology and Immunology. Vol. 368. pp. 1-27. doi:10.1007/82_2012_280. ISBN 978-3-642-36339-9. PMID ... These vaccines, which are still in the development phase, expose the person to proteins present on the surface of the group A ... Research published in October 2020 has shown that infection of the bacterium by three viruses has led to stronger strains of ...
Clinical trials are currently underway. Each year, about 400,000 people undergo brain mapping during neurosurgery. This ... In 2011 it was reported control of two robotic arms solving Tower of Hanoi task with three disks using a CNV flip-flop. In 2015 ... Scholia has a topic profile for Brain-computer interface. The Unlock Project (Webarchive template wayback links, CS1 errors: ... The frequency of the phase reversal of the stimulus used can be clearly distinguished in the spectrum of an EEG; this makes ...
"Phase I Clinical Trial of Cilengitide in Children With Refractory Brain Tumors: Pediatric Brain Tumor Consortium Study PBTC-012 ... In their class at Yale there were three African-American women out of 102 students. As a medical student at Yale Poussaint was ... Poussaint, Tina Young (2001). "Magnetic Resonance Imaging of Pediatric Brain Tumors: State of the Art". Topics in Magnetic ... Journal of Clinical Oncology. 28 (18): 3069-3075. doi:10.1200/JCO.2009.26.8789. ISSN 0732-183X. PMC 2903337. PMID 20479404. ...
Each debriefing session follows seven phases: Introduction to set rules fact phase to establish what happened cognition phase ... Teams can easily get into the weeds and spend valuable time discussing topics that can be taken offline or tabled for a later ... Society of Clinical Psychology: Division 12 of The American Psychological Association. 19 August 2014. Retrieved 9 September ... Debriefings in the military originated for three purposes: to mitigate the psychological impact of traumatic events, alleviate ...
See Carrageenan#Medical Uses The phase III clinical trial for carrageenan-based Carraguard showed that it had no statistical ... World Health Organization (2002). "HIV/AIDS Topics: Microbicides". Geneva: World Health Organization. Retrieved August 28, 2006 ... Several different gel formulations are currently undergoing testing in phase III clinical efficacy trials, and about two dozen ... have failed to demonstrate efficacy in preventing HIV transmission in phase III clinical multicenter trials. PRO 2000 was ...
"Final 10-year results of the Breast International Group 2-98 phase III trial and the role of Ki67 in predicting benefit of ... The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer. ... Ki-67+Antigen at the US National Library of Medicine Medical Subject Headings (MeSH) ... Ki-67 protein is present during all active phases of the cell cycle (G1, S, G2, and mitosis), but is absent in resting ( ...
... results of a controlled crossover trial". PLOS Clinical Trials. 2 (2): e7. doi:10.1371/journal.pctr.0020007. PMC 1851732. PMID ... "Clinical Practice Guideline for the Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders: Advanced Sleep-Wake Phase ... "Light Therapy - Topic Overview". WebMD. 30 June 2009. Retrieved 11 July 2012. Sanassi Lorraine A (2014). "Seasonal affective ... Westrin, Åsa; Lam, Raymond W. (October 2007). "Seasonal Affective Disorder: A Clinical Update". Annals of Clinical Psychiatry. ...
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. ... In 2005, TIK-301 was expected to go into phase III trials. TIK-301 is a high affinity nonselective MT1/MT2 agonist. Studies ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. Mody S, Hu Y, Ho MK, Wong ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ...
"Pyrimethamine ALS trial". Archived from the original on 19 October 2012. Scholia has a topic profile for Pyrimethamine. " ... It is being evaluated in clinical trials as a treatment for amyotrophic lateral sclerosis. Sulfadoxine/pyrimethamine " ... a phase I pilot study". Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration. 14 (3): 199-204. doi:10.3109/17482968.2012 ... Pyrimethamine has also been used in several trials to treat retinochoroiditis. Pyrimethamine is labeled as pregnancy category C ...
An overview of the efficacy, tolerability and pharmacokinetics from three phase II dose-ranging studies. Casodex Study Group". ... Cockshott ID (2004). "Bicalutamide: clinical pharmacokinetics and metabolism". Clinical Pharmacokinetics. 43 (13): 855-878. doi ... a phase II noncomparative multicenter trial evaluating safety, efficacy and long-term endocrine effects of monotherapy". The ... This is a controversial topic [...], but when given in combination with medical or surgical castration, any rise in serum LH ...
There are three main categories that juvenile serial killers can fit into: primary, maturing, and secondary killers. There have ... Another such killer was nurse Jane Toppan, who admitted during her murder trial that she was sexually aroused by death. She ... 1991). Children and young adults with sex chromosome aneuploidy: follow-up, clinical and molecular studies. Birth defects ... in which departments get together and focus on a specific set of topics. With serial murders, the focus is typically on ...
The most promising neutralizing agent is a bispecific monoclonal antibody that entered a first-in-human clinical trial in 2019 ... initially focusing on clinical virology and select topics in HIV pathogenesis. In the mid 1990s, his research team conducted a ... Ho has three older children: Kathryn, Jonathan, and Jaclyn. He lives with his partner, Tera Wong, and their child, Jerren Ho. ... In fact, one such agent, cabotegravir, has recently completed Phase-3 efficacy trials in high-risk populations, in ...
The clinical value of these findings is the subject of ongoing investigations, but recent researches suggest an acceptable ... Liang P, Wang Z, Yang Y, Li K (2012). "Three subsystems of the inferior parietal cortex are differently affected in mild ... While functional connectivity can refer to correlations across subjects, runs, blocks, trials, or individual time points, ... Other methods for characterizing resting-state networks include partial correlation, coherence and partial coherence, phase ...
... and promised field trials of the diagnosis have not been published." Some cultures have three or more defined genders. The ... Psychiatric distress and impairment were found to be higher in the beginning phase of the study but after HRT, there was a ... Ashley's stance that gender euphoria does not need to be preceded by a clinical diagnosis of gender dysphoria, and that gender ... List of transgender-related topics Transmedicalism Gender transitioning Detransition ICD-11 § Gender incongruence "Gender ...
In March 2015, a Phase II clinical trial and a Phase III started in Guinea at the same time; the Phase II trial focused on ... Scholia has a topic profile for RVSV-ZEBOV vaccine. "Ebola Vaccine VSVDG-ZEBOV". Drug Information Portal. U.S. National Library ... Manufacturing of the vaccine for the Phase I trial was done by IDT Biologika. Manufacturing of vaccine for the Phase III trial ... The committee found that data from the Phase III Guinea trial were difficult to interpret for several reasons. The trial had no ...
From the applied behavior analysis literature, behavioral psychology, and from randomized clinical trials, several evidenced ... "Topics in Brief: Prescription Drug Abuse". National Institute on Drug Abuse. December 2011. Archived from the original on 24 ... Three countries in Europe have active HAT programs, namely England, the Netherlands and Switzerland. Despite critical voices by ... Studies have shown that the large majority of adolescents will phase out of drug use before it becomes problematic. Thus, ...
Two systematic reviews found no adverse effects of exogenous melatonin in several clinical trials, and comparative trials found ... Mundey K, Benloucif S, Harsanyi K, Dubocovich ML, Zee PC (October 2005). "Phase-dependent treatment of delayed sleep phase ... Melatonin appears to cause very few side effects as tested in the short term, up to three months, at low doses.[clarification ... PDQ Integrative, Alternative, and Complementary Therapies Editorial Board (May 2013). "Topics in complementary and alternative ...
Vanderbilt University Medical Center, Nephrology Clinical Trials Center. Recruiting. Nashville, Tennessee, United States, 37232 ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase 2/3 Adaptive Study of VX-147 in Adults With APOL1- Mediated Proteinuric Kidney Disease. The safety and scientific ... ... Phase Proteinuric Kidney Disease Drug: VX-147 Drug: Placebo ...
MedlinePlus Genetics related topics: Rheumatoid arthritis MedlinePlus related topics: Arthritis Rheumatoid Arthritis ... Trial record 1 of 4 for: Nichi-Iko Previous Study , Return to List , Next Study ... A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE). The safety and scientific validity of this study is ... 1 protein kinase inhibitor for RA either as part of clinical management or during a clinical study ...
Clinical trials. Learn about our clinical trials and find available studies. *Merck Manuals. Medical information source ... covering thousands of topics in all fields of medicine. Environmental, Social & Governance (ESG). * Environmental, Social & ... clinical trials, visit About Merck. For more than a century, Merck, a leading global. ... clinical trials of LYNPARZA in the first-line maintenance setting for. SOLO-1 were: decrease in hemoglobin (87%), increase in ...
Clinical trials. Learn about our clinical trials and find available studies. *Merck Manuals. Medical information source ... covering thousands of topics in all fields of medicine. Environmental, Social & Governance (ESG). * Environmental, Social & ... For more information about our oncology clinical trials, visit ... The trial enrolled 1,579 patients who were randomized to receive KEYTRUDA (200 mg every three weeks for up to approximately two ...
Clinical Trial, Phase II [‎8]‎. Clinical Trial, Phase III [‎7]‎. Clinical Trials as Topic [‎20]‎. ...
Clinical Trials, Phase III as Topic * Colorectal Neoplasms / radiotherapy* * Embolization, Therapeutic* * Fluorodeoxyglucose ...
Clinical Trial, Phase II [‎8]‎. Clinical Trial, Phase III [‎7]‎. Clinical Trials as Topic [‎20]‎. ...
In-depth coverage of innovation, business, financing, regulation, science, product development, clinical trials and more ... Positive phase III clinical trial data for Sinocelltechs COVID-19 vaccines. Oct. 25, 2022 ... Home » Topics » Infection » Coronavirus. Coronavirus RSS Inotrems nangibotide shines in curtailed COVID-19 trial. Oct. 25, ... has reported positive interim data for two COVID-19 vaccine candidates, SCTV-01C and SCTV-01E, from phase III trials in the ...
Contact: US Biogen Clinical Trial Center. 866-633-4636. ... MedlinePlus related topics: Edema Drug Information available for: Glyburide Genetic and Rare Diseases Information Center ... Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following ... Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our ...
Randomized Controlled Trials as Topic. 4. 2018. 2020. October 2019. Clinical Trials, Phase III as Topic. 1. 2020. 2020. ... Randomized Controlled Trials as Topic. Clinical Trials, Phase III as Topic. Empirical Research. Colorectal Neoplasms, ... Statistics as Topic. Clinical Trials as Topic. Survival Analysis. Proportional Hazards Models. Survival Rate. Kaplan-Meier ... The average publication date for each concept is shown as a red circle, illustrating changes in the primary topics that Miki ...
Phase III clinical trials, the Dalmia Group firm said in a statement. "We are conducting human trials of our highly efficient ... Top Trending Topics. Crude Oil PricesTamil Nadu CycloneMarket TomorrowAmazonJohn CenaRishi SunakMarket Outlook For Next Week ... Dalmia Healthcare starts clinical trials to study efficacy of ayurvedic drug for COVID-19. All regulatory guidelines will be ... Top Trending Topics. Section 144 In MumbaiIphone 13Coronavirus Cases In MumbaiVijay MallyaImei NumberCentral Govt Employee ...
Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active ... Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of ... Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of ... Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin ...
Clinical Trials, Phase III as Topic 6 * Local Health Systems 5 * China 5 ... Clinical Study, Plasma/immunology, Instituto Butantan, Plano São Paulo, COVID-19 ...
Rutgers University is a clinical trial site for the Janssen Pharmaceutical Companies of Johnson & Johnsons phase 3 clinical ... be considered for the vaccine clinical trial and other COVID-related research can click here or email or rutgers-covid-trials@ ... "Our research team will enroll a large number of volunteers into this extremely important vaccine trial. We will be offering ... "Its critical to have diverse participants in a coronavirus vaccine trial so we know it is effective for populations that are ...
Joint Review of the Phase III Malaria vaccine clinical trial protocol. *Conjugate meningococcal A vaccine trial ... More clinical trials are increasingly being planned for Africa to evaluate efficacy and safety of candidate vaccines.. ... Cholera and HPV vaccines clinical trials. *New tools have been made available to WHO/AFRO countries to enable them to further ... To sustain and/or build new partnerships in the furtherance of capacity building and conduct of vaccine clinical trials. ...
He also participated in an FDA phase III clinical trial for a dry eye therapy developed by Inspire Pharmaceutical. ... Wan's many lectures have involved such topics as: Current Trends, Advanced Contact Lens Fitting and Materials; Red Eyes ... Case Presentation and Clinical Pearls, PRK/LASIK. He has written articles for Optometric Economics, Occupational Health and ... Dry Eyes and Practical Clinical Pearls; Specialty Contact Lenses and Advanced Bifocal Fitting; Corneal Topography Analysis ...
8. To promote research in the region and collaborate in phase I, II and III clinical trials ... Guest lecture by local and national speakers attend followed by an informal meal with discussion and networking.CPD topics ... The Three Counties Allergy Group Meeting (TCAG). Currently, over 25 members affiliated to hospitals around the Three Counties ... New members - both clinical and academic - are always welcome and can in the first instance contact Dr Lynn Morrice, the AARG ...
5 Phase III clinical trial preparation (as continuation of the Phase I-II clinical trial if successful). 6 Contribution towards ... These objectives were in complete accordance with the targeted topic of the FP7-2013 Health Programme (i.e. HEALTH-2013.2.3.1-1 ... 3.2 WP2 - PREPARATION OF THE PHASE I-II CLINICAL STUDY. WP2 aimed at efficiently preparing the phase I-II clinical study of the ... PhagoBurn planed and conducted a prospective, randomised, phase I-II clinical trial in three different European countries ...
Full results of the trial released last month were presented at ECTRIMS. It is the first oral drug to have been shown effective ... Table 2. TOPIC Key Secondary Endpoint: Risk for New Clinical Relapse or MRI Lesion vs Placebo ... in the TOPIC trial.. The higher 14-mg dose appeared more effective than the 7-mg dose, particularly on reducing brain lesions ... Full results of the phase 3 Teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis (TOPIC) ...
Phase I, II, III, or IV clinical trials to evaluate the safety and efficacy of new contraceptive methods for women and men ... CDRCP research topics include: *Developing a male contraceptive that inhibits an enzyme needed to produce sperm ... In 1996, NICHD established the Contraceptive Clinical Trials Network (CCTN) to conduct clinical trials of new contraceptive ... Sites within the CCTN, funded through the CRB, are chosen based on their capacity to conduct Phase I, II, and III trials for ...
Oramed Announces Additional Positive Safety and Efficacy Data from Its Phase 2 Clinical Trial … From Oramed Pharmaceuticals ... Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. ... Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. ... Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. ...
A clinical trial is an organized study to answer specific questions about a new drug or treatment or a new way of using an old ... search for other Phase III trials, then Phase II, then Phase I. (For information about clinical trial phases, click here.) ... Post a Comment Have something to add to this topic? Contact Us.. Name. Login to use your name. Anonymous. ... How To Locate A Clinical Trial. Next » « Previous 6/14. There is no single place that lists every clinical trial. However, ...
Clinical. View MoreAllergy, Immunology, and ENTCardiologyDermatologyDrug Pipeline NewsEmergency MedicineEndocrinology ... Results of the pivotal phase 3 primary PREVENT-19 trial were published in the New England Journal of Medicine.2 The trial ... This article was originally published by sister publication Drug Topics.. References. *Novavax announces positive results of ... Trial investigators emphasized the importance of ensuring "well balanced racial and ethnic representation among participants." ...
Until a few days ago, Carfilzomib was a drug in Phase III clinical trials not expected to be approved for at least another six ... began progressing through the clinical trials process from Phase I forward, it has been a regular topic of interest on the IMF ... At the recent International Myeloma Workshop in Paris, we noted that in multiple clinical studies carfilzomib has a "positive ... 501(c)(3) not-for-profit charity. Tax ID: 95-4296919. © 1990 ‐ 2022 International Myeloma Foundation. All Rights Reserved. ...
The clinical trial process occurs in three phases. Phase I studies determine if a treatment is safe for people and identify its ... Topics in the Gene Therapy and Other Medical Advances chapter. *What is gene therapy? ... to follow when conducting clinical trials with gene therapy. These guidelines state that clinical trials at institutions ... Phase II studies determine if the treatment is effective, meaning whether it works. Phase III studies compare the new treatment ...
In clinical trials, this vaccine was 66% effective in preventing the COVID-19 virus with symptoms - as of 14 days after ... You still need to show a negative test result or proof that youve recovered from COVID-19 in the past three months before ... However, both animal studies were conducted after these vaccines were already in phase 3 clinical trials. ... Johnson COVID-19 vaccine have been given to pregnant women in each trimester of pregnancy in clinical trials. No harmful ...
What are the clinical features of angioimmunoblastic T-cell lymphoma?. More than 70% of patients with angioimmunoblastic T-cell ... Trials of histone deacetylase (HDAC) inhibitors, hypomethylating agents, and anti-CD30 antibodies are on-going [20-23]. ... Patients usually present with late stage III-IV disease, and survival rates have been quoted as being 33% 5 years and 29% at 7 ... Due to the rarity of angioimmunoblastic T-cell lymphoma, therapy is generally guided by prospective phase II studies [4]. ...
The brother of Cure Rare Disease founder and CEO Rich Horgan died in a clinical trial of a CRISPR therapeutic sponsored by the ... The BLA includes efficacy and safety data from three clinical studies: The Phase I/II SRP-9001-101 (NCT03375164); the Phase II ... "We anticipate sharing the three-year results from all 134 participants in our Phase III study in early 2023." ... and the Phase III SRP-9001-103 (also called ENDEAVOR; NCT04626674), as well as an integrated analysis across these three ...
  • Since 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) is applicable. (
  • Trending Clinical Topic: Periodontal Disease - Medscape - May 20, 2022. (
  • 2022;186(3):453-465. (
  • KEYNOTE-859 is a randomized, double-blind Phase 3 trial ( , NCT03675737 ) evaluating KEYTRUDA in combination with chemotherapy compared to placebo in combination with chemotherapy for the first-line treatment of patients with HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. (
  • The trial enrolled 1,579 patients who were randomized to receive KEYTRUDA (200 mg every three weeks for up to approximately two years) in combination with fluoropyrimidine- and platinum-containing chemotherapy, or placebo in combination with chemotherapy. (
  • Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial "yielded. (
  • Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB. (
  • Full results of the phase 3 Teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis (TOPIC) trial were reported at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS). (
  • When a clinical trial is blinded, the participants are unaware as to whether they are receiving the experimental drug or a placebo (or another drug). (
  • In May, a long-awaited randomized, double-blind, placebo-controlled, Phase 3 clinical trial testing MDMA-assisted therapy for the treatment of PTSD was published in Nature Medicine . (
  • A phase 3 study assessing the use pregabalin as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint to reduce seizure frequency compared with placebo. (
  • Findings from the phase 3 study showed that treatment with pregabalin for PGTC seizures did not result in a statistically significant reduction in seizure frequency versus placebo. (
  • These trials are randomized, well controlled and include a placebo group. (
  • The trials are randomized and double blind-neither the trial participants nor the health officials know which participants are receiving the vaccine and which are getting the placebo. (
  • The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression. (
  • For example, in 2012 the pharmaceutical company GlaxoSmithKline paid $3 billion after it failed to disclose trial data demonstrating that its antidepressant Paxil was not only no more effective than placebo during their trials, but that it was also linked to increased suicide attempts among teenagers ( Source ). (
  • Among patients treated with REGEN-COV who had symptomatic COVID-19 recovered in 1 week, compared with 3 weeks among those in the placebo arm. (
  • The double-blind LIBERTY AD CHRONOS trial randomly assigned patients with moderate to severe AD to either 300 mg dupilumab (n=106) or placebo (n=315), both of which were administered every 2 weeks for 52 weeks. (
  • Patients receiving background, maximally tolerated statins also received 300 mg inclisiran sodium (n=1833) or placebo (n=1827) in all 3 trials. (
  • The NDA for SUN-101/eFlow ® is based on data from clinical trials in the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing SUN-101/eFlow ® with placebo in adults with moderate-to-very severe COPD. (
  • GOLDEN-3 and GOLDEN-4 were Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing SUN-101/eFlow ® with placebo in adults with moderate-to-very severe COPD. (
  • In the phase 3 double-blind trial, 20,099 children 4 to 16 years old at 26 centers in endemic areas of Asia and Latin America were randomly assigned to receive two doses of the live TAK-003 vaccine or two doses of placebo 3 months apart from September 2016 to August 2017. (
  • The objective of this project is to assess the feasibility of macrolides to attenuate or reverse the decrease in %predicted FEV1 in adults with SCA in a single-site, randomized, placebo-controlled feasibility trial. (
  • In vitro, in vivo, epidemiologic, and clinical trial evidence that selenium supplementation protects against prostate cancer motivated the study we report here: a double-blind, randomized, placebo-controlled trial of selenium 200 (μg/d) as selenomethionine in men with HGPIN. (
  • Novartis has released new data from an interim analysis of its randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of. (
  • The trial (median length six months) was not powered to determine overall survival, but there were four deaths (three [0.9%] in the ribociclib group and one (0.3%) in the placebo group) during treatment. (
  • To analyse conjunctivitis data recorded in five randomized, placebo-controlled trials of tralokinumab in adult patients with moderate-to-severe AD. (
  • Most events were mild or moderate in severity, and 78·6% and 73·9% of events resolved during the trial in the tralokinumab and placebo groups, respectively. (
  • One of the hottest topics of 2021 was psychedelics , and while many start-ups emerged in hopes of securing their spot in the burgeoning industry, the work of one corporation in the sector stood out from the rest. (
  • 2021;326(3):230-239. (
  • Trending Clinical Topic: COVID Antiviral Drug - Medscape - Oct 15, 2021. (
  • Trending Clinical Topic: COVID Antibody Cocktail - Medscape - Apr 23, 2021. (
  • Below we highlight two studies addressing this topic at the 2021 SABCS. (
  • From dental concerns in patients with T2D to concerning associations between gum disease and CRC and AD, research into links between periodontal disease and various serious conditions resulted in this week's top trending clinical topic. (
  • Promising interim results for an oral COVID-19 antiviral drug, along with news about other treatments currently used and in development, resulted in this week's top trending clinical topic. (
  • As the pandemic and prevention strategies continue, news about the development of COVID antiviral drugs is eagerly anticipated, leading to this week's top trending clinical topic. (
  • The company has now unveiled phase 3 results of a prevention trial (see Infographic below), which resulted in this week's top trending clinical topic. (
  • KENILWORTH, N.J.-( BUSINESS WIRE )-AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada), today presented full results from the Phase 3 SOLO3 trial which evaluated LYNPARZA, compared to chemotherapy, for the treatment of platinum-sensitive relapsed patients with germline BRCA1/2 -mutated (g BRCA m) advanced ovarian cancer, who have received two more prior lines of chemotherapy. (
  • José Baselga, executive vice president, Oncology R&D, AstraZeneca, said, "This trial shows that LYNPARZA has the potential to provide a much-needed improvement and alternative over standard-of-care chemotherapy for certain patients with relapsed BRCA -mutated advanced ovarian cancer. (
  • RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. (
  • The results from KEYNOTE-859 show the potential of KEYTRUDA plus chemotherapy to improve survival beyond chemotherapy alone for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression," said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. (
  • We are excited by these new results that demonstrate our commitment to exploring new treatment options for patients fighting gastrointestinal cancers with KEYTRUDA and thank all investigators and patients who participated in this trial. (
  • Inotrem SA obtained an unexpectedly robust efficacy signal from a curtailed phase II trial of nangibotide, an inhibitor of triggering receptor expressed on myeloid cells 1, in patients with severe COVID-19. (
  • Three years after WHO declared the COVID-19 pandemic, some patients are still reporting symptoms from long-ago infections. (
  • We are conducting human trials of our highly efficient ayurvedic composition which can potentially help in curing COVID-19 patients," Dalmia Group of Companies Chairman Sanjay Dalmia said. (
  • COPENHAGEN, Denmark - Both doses of teriflunomide ( Aubagio , Genzyme/Sanofi) reduced the risk for conversion to clinically definite multiple sclerosis (MS) in patients with clinically isolated syndrome (CIS), in the TOPIC trial. (
  • for patients who wish to participate in clinical trials in designated National Cancer Institute cancer centers. (
  • A for profit site which matches patients' personal profiles (including disease stage and prior treatments) to enrollment criteria for trials on a computer generated basis. (
  • Consultants call patients who have registered with the service when a new trial comes up. (
  • Highlights include 2 late-breaking abstracts, one of which presents findings from the AURORA phase 3 clinical trial showing that patients with active lupus nephritis experience improved renal outcomes with voclosporin. (
  • The current FDA approvals [for these patients] include agents such as abiraterone and enzalutamide, but in the ALSYMPCA trial there was no utilization of these agents. (
  • 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. (
  • Clinical trials , which are required as part of the process of getting Food and Drug Administration (FDA) approval, can vary in the number of patients who take part and the design of the study, but they must all follow a strict set of criteria that protects patients. (
  • A health advisor can also be a good resource for the latest information on promising trials that are enrolling patients and can help you decide if a clinical trial is appropriate for your particular health situation. (
  • Ultimately, however, phase III randomized data will be critical to establish concrete recommendations for this high-cure-rate population of cancer patients. (
  • The patients had T0-3 N0-2 M0 disease, ≤10 pack-year smoking history or abstinence for at least 5 years, and good performance status. (
  • 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. (
  • The dosage findings for the first 20 patients in the phase 1 trial were presented June 1 at the. (
  • In a phase 3 randomized trial, researchers assessed the effects of canakinumab treatment on survival outcomes in patients hospitalized with severe COVID-19 who did not require invasive mechanical ventilation. (
  • Phase II studies are performed on groups of patients (normally 100-300) and are designed to test for efficacy in the clinical situation, and if this is confirmed, to establish the dose to be used in the definitive phase III study. (
  • Phase III studies are the definitive double-blind randomised trials, commonly performed as multicentre trials on 1000-3000 patients, aimed at comparing the new drug with commonly used alternatives. (
  • Phase IV studies comprise the obligatory post marketing surveillance designed to detect any rare or long-term adverse effects resulting from the use of the drug in a clinical setting in many thousands of patients. (
  • The NDA submission includes results from a clinical trial program that included over 1900 patients. (
  • The trial included 643 generally healthy patients aged 55-80 years (mean age, 69 years) with mild to moderate AD. (
  • Intraoperative complications were identified in 3/75 patients (4%) and 90-d postoperative complications in 19/75 (25%), including two patients (3%) with high-grade (Clavien ≥III) complications. (
  • In terms of drugs currently being used to fight COVID, a phase 3 trial found that remdesivir cut some patients' risk for hospitalization or all-cause death by 87% . (
  • Higher Risk of Infections with PI3K-AKT-mTOR Pathway Inhibitors in Patients with Advanced Solid Tumors on Phase I Clinical Trials. (
  • The IDSA guidelines also recommend the use of tocilizumab in certain patients and recommended against use of ivermectin outside of clinical trials. (
  • ATSDR's National ALS Registry and Biorepository connect patients with clinical trials and advances research on risk factors, genetics, biomarkers, and etiologies. (
  • The Registry team has strengthened its collaborations and partnerships with institutions by helping recruit patients for dozens of clinical trials and epidemiologic studies. (
  • These studies range from Phase 2 and Phase 3 clinical trials for pharmaceutical companies to self-administered surveys on how patients adapt and cope with their diagnosis. (
  • Encorafenib plus binimetinib is the third BRAF-MEK inhibitor combination therapy to undergo phase 3 clinical testing for the treatment of patients with BRAF - V600 -mutant melanoma. (
  • 1 "These data suggest that there are inherent differences in the pharmacological characteristics of the drugs used in BRAF-MEK inhibitor therapy, and that some combinations might provide additional clinical benefits to patients. (
  • Twice-yearly inclisiran, in addition to maximally tolerated statin therapy, was found to be safe and effective in lowering low-density lipoprotein cholesterol (LDL-C) in adult patients with heterozygous familial hypercholesterolemia (FH), atherosclerotic cardiovascular disease (ASCVD), or ASCVD risk equivalents, according to results from a pooled analysis of phase 3 published in the Journal of the American College of Cardiology . (
  • In the current analysis, the researchers used pooling data from 3 phase 3 studies to precisely assess the efficacy of inclisiran treatment and evaluate treatment safety and tolerability in patients with FH or ASCVD. (
  • Pooled patient-level analysis of inclisiran trials in patients with familial hypercholesterolemia or atherosclerosis. (
  • SUN-101/eFlow ® demonstrates Sunovion's commitment to delivering innovative therapies for patients with COPD," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. (
  • There are not enough patients for the number of trials needed. (
  • About 10% of adult glioblastoma patients-about 2,000 per year-enter clinical trials. (
  • There are currently 318 glioblastoma trials open for enrollment, which means only six patients are available per trial per year. (
  • it takes years to accrue enough patients, and many trials never do. (
  • As patients are treated, we learn how to use the treatments better, but the rigid structure of a phase 3 trial doesn't allow for modifications midstream. (
  • Although patients diagnosed with or receiving therapy for cancer were excluded from the initial vaccine trials, emerging evidence now supports vaccine safety with potentially diminished immune response in this group. (
  • We report the whole-genome sequencing of 485 chronic lymphocytic leukemia patients enrolled in clinical trials as part of the United Kingdom's 100,000 Genomes Project. (
  • Analysis of additional blood specimens obtained from seven case-patients documented slightly elevated liver function tests in all seven patients and thrombocytopenia in three patients. (
  • In the separate DISCOVER 2 trial, psoriasis patients receiving Tremfya demonstrated significant improvements in anxiety, depression, fatigue and other measures. (
  • His current role is Global Products Manager and Global Alliance Manager for Tralokinumab, an anti-IL-13 monoclonal antibody for the treatment of patients with severe asthma presently undergoing phase III clinical trials. (
  • [ 3 , 11 ] Ophthalmological side-effects during dupilumab treatment have only been observed in patients with AD and not in studies of chronic sinusitis with nasal polyps, asthma or eosinophilic oesophagitis, [ 12-14 ] suggesting AD-specific predisposing factors. (
  • [ 24-26 ] Conjunctivitis was therefore recorded as an AE of special interest (AESI) in the tralokinumab phase III trials, and it is important to examine these data for insight into the incidence and profile of conjunctivitis in patients treated with tralokinumab. (
  • As reported in the Journal of Clinical Oncology by Olivia Pagani, MD , and colleagues, 13-year follow-up in a combined analysis of the phase III TEXT and SOFT trials has shown continued disease-free survival and distant recurrence-free interval benefit-but no overall survival benefit-with exemestane plus ovarian function suppression (OFS) vs tamoxifen plus OFS in premenopausal patients with estrogen/progesterone receptor-positive breast cancer. (
  • In this study, patients will receive pembrolizumab with three chemotherapy drugs: gemcitabine, vinorelbine, and liposomal doxorubicin. (
  • The EMERALD trial is a global, phase III trial that randomized 477 metastatic ER+/HER2- patients who had progressed on a CDK4/6 inhibitor and also patients who had received no more than one line of chemotherapy. (
  • In the trial, patients who were switched saw a doubling of PFS. (
  • Some patients have gone from using the bathroom 10 times a day to only 3 - which is a huge impact on their lives. (
  • In 1 of the patients with 4 lesions, 1 lesion showed complete cure and 3 showed partial cure. (
  • BrainStorm Cell Therapeutics announced on January 5 positive final results from its phase 2a clinical trial of NurOwn in ALS patients, with nearly all subjects in the study experiencing clinical benefit. (
  • Of the 12 patients with 3 or more months of follow-up after administration of NurOwn, 92% experienced an improvement in the rate of disease progression. (
  • Israel's BrainStorm says stem cell drug benefits most patients in ALS trial. (
  • We conducted this prospective, non-randomized phase II study to evaluate the feasibility and efficacy of cisplatin and gemcitabine as adjuvant treatment in patients with resected BTC. (
  • Surgery is the only curative treatment for BTC patients, but only a minority of patients are cured [ 3 ]. (
  • Our ability to advance the nusinersen program as quickly as we have is largely due to the tremendous contributions of the entire SMA community, from the patients and families who participated in the clinical trials to the doctors, nurses and advocates who work tirelessly on their behalf," said B. Lynne Parshall, chief operating officer at Ionis Pharmaceuticals. (
  • The regulatory submissions are comprised of results from the pre-specified interim analysis of ENDEAR, the controlled Phase 3 study evaluating nusinersen in infantile-onset (most likely to develop Type 1) SMA, as well as all other clinical and preclinical data currently available, which includes open-label data in other patients types. (
  • of treatment, and no large randomised trials are available for paediatric patients. (
  • SOLO3 is a Phase 3 randomized, open-label, controlled, multi-center trial to evaluate the efficacy and safety of LYNPARZA tablets following two or more prior lines of chemotherapy. (
  • More clinical trials are increasingly being planned for Africa to evaluate efficacy and safety of candidate vaccines. (
  • Once a clinical trial indicates that a COVID-19 vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required. (
  • SPR1NT (NCT03505099), a Phase III, multicenter, single-arm trial, investigated the efficacy and safety of onasemnogene abeparvovec for presymptomatic children with biallelic SMN1 mutations treated within six postnatal weeks. (
  • [ 19-21 ] Tralokinumab has demonstrated efficacy and safety in a number of phase II and phase III trials in AD. (
  • An additional study, GOLDEN-5, was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long term safety and tolerability of SUN-101/eFlow ® in adults with moderate-to-very severe COPD and included the active comparator Spiriva ® (tiotropium bromide) delivered by the HandiHaler ® device. (
  • The key question in this multicenter "switch" trial of women newly diagnosed with metastatic ER+/HER2- breast cancer, is whether ESR1 mutations can be detected through a blood test before they become clinically relevant and breast cancer progresses. (
  • Methods: Data from NINDS Exploratory Trials in PD Long-Term Study 1 (NET-PD LS1), a multicenter Phase 3 study of creatine in early treated PD, were analyzed. (
  • As of September 2020, there were more than 3 million reported cases in the Americas [1] and the economic impact is considered to be significant. (
  • Dupilumab prevents flares in adults with moderate-to-severe atopic dermatitis in a 52-week randomized controlled phase 3 trial [published online May 6, 2020]. (
  • Clinical trials for this drug candidate are expected to start in 2020. (
  • The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period. (
  • Rutgers University is a clinical trial site for the Janssen Pharmaceutical Companies of Johnson & Johnson's phase 3 clinical research study to evaluate the safety and efficacy of Janssen's COVID-19 vaccine candidate. (
  • In the context of a worldwide growing antibiotic resistance threat, notably the emergence of multi-drug resistant, even pan-resistant, bacterial strains, PhagoBurn was launched to evaluate the clinical potential of bacteriophages (phages) as a novel and innovative strategy to fight this critical issue. (
  • The brother of Cure Rare Disease founder and CEO Rich Horgan dies in a clinical trial sponsored by the nonprofit to evaluate the CRISPR therapeutic CRD-TMH-001, which is designed to treat a rare mutation of DMD. (
  • Terry Horgan was the sole participant in a Phase I study ( NCT05514249 ) designed to evaluate CRD-TMH-001, which is designed to treat a rare mutation of Duchenne muscular dystrophy (DMD). (
  • At this point in the clinical trial process, researchers are working to evaluate the effectiveness of the new treatment compared to standard treatment for the disease. (
  • In a clinical trial, a clearly defined outcome which is used to evaluate whether a treatment is working or not. (
  • This manuscript describes results of a randomized discontinuation trial (RDT) designed to evaluate the effects of pegvaliase treatment on blood phenylalanine (Phe) and neuropsychiatric outcomes in adults with PKU. (
  • This made it possible to develop COVID-19 vaccines and fully evaluate them in clinical trials much faster than before. (
  • The neuroprotective potential of urate has been so encouraging that an interventional trial to evaluate the effect of increasing urate on PD progression (SURE-PD) is in Phase III, having already shown feasibility and safety. (
  • The purpose of this study was to evaluate the clinical performance of carrier screening for cystic fibrosis, hemoglobinopathies, and spinal muscular atrophy with reflex single-gene noninvasive prenatal screening (sgNIPS), which does not require paternal carrier screening. (
  • Participants will receive VX-147 with the dose to be based on the outcome of Phase 2. (
  • It's critical to have diverse participants in a coronavirus vaccine trial so we know it is effective for populations that are often underrepresented in research," said XinQi Dong , director of the Institute for Health, Health Care Policy and Aging Research and co-lead investigator who is directing community recruitment for the Johnson & Johnson trial. (
  • Trial investigators emphasized the importance of ensuring "well balanced racial and ethnic representation among participants. (
  • 2 The trial enrolled 30,000 adult participants across the United States and Mexico and demonstrated a 90.4% overall efficacy, as well as high safety and tolerability. (
  • The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. (
  • Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proving or disproving the goal of the clinical trial sponsor. (
  • Background: Numerous barriers and challenges can hinder the successful enrollment and retention of study participants in clinical trials targeting minority populations. (
  • The trial, involving 4,115 adults, aged 18 years and above, across 44 sites in the U.S., met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95%CI: 96.2-99.6). (
  • The RDT, Part 2 of PRISM-2, was an 8-week trial that evaluated change in blood Phe concentrations, neuropsychiatric and neurocognitive measures, and safety outcomes in PRISM-2 participants who had achieved at least a 20% blood Phe reduction from pre-treatment baseline with pegvaliase treatment. (
  • Vaccine trial designs should account for the known period of cross-protection between serotypes and be extended to the period when enhanced disease could potentially occur, which means that trial design must include active surveillance of trial participants, ideally up to 4 to 5 years," she wrote. (
  • Of the participants, 1,479 (82%) completed the trial. (
  • Previous single dose and 10 day dosing studies had been uneventful, but when another dose schedule was tried, an acute and rapidly progressive neurological syndrome developed in three of the four participants, starting on the fifth day of drug administration. (
  • Here's a trial done in 34 German hospitals that took over four years , because the 380 participants were adults with severe sepsis but not septic shock. (
  • Trials usually have a single primary endpoint (e.g. having an undetectable viral load) as well as a few secondary endpoints, covering other aspects of treatment safety, tolerability and efficacy. (
  • The protocol was evaluated in a phase II trial that had a primary endpoint of pathologic complete response. (
  • The primary endpoint was progression of HGPIN to prostate cancer over a 3-year period. (
  • The trial enrolled 14 subjects at Hadassah Medical Center in Jerusalem, achieving its primary endpoint in demonstrating that the treatment is safe and well tolerated up to 2 million cells per kilogram administered intrathecally and 48 million cells administered intramuscularly. (
  • The dossier required for this is a massive and detailed compilation of preclinical and clinical data. (
  • Our findings have far-reaching implications as the socio-ecological model approach is adaptable to developed and developing regions and has the potential to increase recruitment and retention of hard-to-reach populations who are typically under-represented in clinical trials. (
  • The goal is to confirm any positive findings from the smaller Phase II trials. (
  • New findings from a phase III clinical trial suggest the IDH1 gene may be a prognostic marker for anaplastic astrocytoma, a rare form of brain cancer. (
  • Fully human monoclonal antibody dupilumab provides long-term control of atopic dermatitis (AD) and prevents disease flares, which may help reduce the need for escalation and/or intensification of therapy, according to study findings from the phase 3 LIBERTY AD CHRONOS trial published in the Journal of the American Academy of Dermatology . (
  • These tragic stories remind us how medical knowledge increases through the risks taken by others, and as Iain Chalmers reminds us, this means that there is a moral imperative to design trials which minimise risk and maximise clinical knowledge, and to disseminate the totality of their findings. (
  • These findings are based on the outcome of progression-free survival (PFS), which to date has not proven to be a good surrogate for clinical benefit such as overall survival and/or quality of life. (
  • This study not only extends our earlier phase 1/2 findings regarding the safety of NurOwn, but also provide a consistent and highly promising picture of NurOwn's efficacy. (
  • Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. (
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (
  • Start your search with studies listed as Phase III, late-stage, large tests on the drug's safety and efficacy. (
  • The service has a current listing of more than 4,000 studies, allowing access to information about virtually all government clinical trials sponsored by the various divisions of the NIH. (
  • 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. (
  • Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). (
  • Phase I studies determine if a treatment is safe for people and identify its side effects. (
  • Phase II studies determine if the treatment is effective, meaning whether it works. (
  • Phase III studies compare the new treatment to the current treatments available. (
  • This course provides an introduction to the design and analysis of clinical trials, epidemiological studies, and methods for the analysis of biostatistical data. (
  • We hope you're enjoying the latest clinical news, full-length features, case studies, and more. (
  • Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. (
  • Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. (
  • This concept includes phase III studies conducted in both the U.S. and in other countries. (
  • Phase I studies may also test for pharmacodynamic effects in volunteers (e. g. does a novel analgesic compound block experimentally induced pain in humans? (
  • Often, such studies will cover several distinct clinical disorders (e. g. depression, anxiety states and phobias) to identify the possible therapeutic indications for the new compound and the dose required. (
  • Studies comparing potential differences between the hydrolyzed sources and forms of collagen I, II, and III are lacking. (
  • Once the clinical studies are complete, a successful candidate vaccine may be licensed for use if it is found to be safe and effective and if its benefits outweigh its side effects. (
  • Swiss TPH has a significant role in the research and development of new malaria vaccines, contributing across the whole development pathway: from discovery, to preclinical studies, and through to human clinical testing in both early and late studies with many African collaborators. (
  • This includes studies at the Clinical Trial Research Unit in Bagamoyo arm of the Ifakara Health Institute. (
  • Swiss TPH has a leading role in assessing the health impact and cost-effectiveness of different malaria vaccines beyond clinical studies. (
  • Currently, more than 20 malaria vaccines candidates are being evaluated at various institutes world-wide, with one vaccine having completed Phase 3 Clinical studies, the malaria vaccine RTS,S/AS01, also known as Mosquirix. (
  • Swiss TPH was integrally involved with partners in the Phase 3 and earlier clinical studies of RTS,S. (
  • Of the 224,000 clinical studies registered on the National Institutes of Health (NIH) website, only 23,000 of them actually display results information ( Source ). (
  • EUAs and have been used for post-vaccine serology determinations for clinical trials and research studies, as noted in published or preprint articles. (
  • The inverse relationship between urate and Parkinson's disease (PD) is among the most consistent clinical association identified in epidemiologic studies, and represents a promising area for intervention. (
  • These tips and resources will help you locate clinical trials and studies enrolling people like you. (
  • Conjunctivitis signals have also been observed in phase II and phase III studies of tralokinumab and lebrikizumab, which specifically inhibit IL-13 signalling. (
  • As for the design, there were 14 qualitative studies, 5 randomized controlled trials, 1 non-randomized trial and 1 cohort study, prevailed. (
  • In clinical studies, adverse reactions can you buy avelox in adolescents 12 to 15 years of age and older. (
  • This project focuses on the reusability of filtering facepiece respirators by conducting laboratory studies to understand: (1) how well decontamination methods work, (2) how decontamination methods on filtering facepiece respirators affect performance, and (3) the risks that can happen when handling a respirator contaminated with virus. (
  • Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "LYNPARZA is the first and only PARP inhibitor to demonstrate efficacy versus chemotherapy in relapsed BRCA -mutated advanced ovarian cancer following two or more prior lines of chemotherapy. (
  • Incorporating a lower dose of cisplatin and lower total radiation dose, the protocol achieved encouraging results without neoadjuvant chemotherapy or routine surgery, Bhishamjit S. Chera, MD, of the University of North Carolina (UNC) at Chapel Hill, and coauthors reported in the Journal of Clinical Oncology . (
  • More data on the topic will emerge from the phase II NRG HN002 collaborative group clinical trial, evaluating reduced-dose intensity modulated-radiotherapy (IMRT) with or without chemotherapy, he added. (
  • This should be taken into consideration during the design and conduct of trials involving PI3K-AKT-mTOR pathway inhibitors, particularly when combined with chemotherapy or myelosuppressive agents. (
  • Results of the pivotal phase 3 primary PREVENT-19 trial were published in the New England Journal of Medicine . (
  • Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. (
  • PRISM-2 Investigators 2018, ' Pegvaliase for the treatment of phenylketonuria: A pivotal, double-blind randomized discontinuation Phase 3 clinical trial ', Molecular Genetics and Metabolism , vol. 124, no. 1, pp. 20-26. (
  • I would like to thank everyone who participated in the trial and who continued to advance the trial during the pandemic. (
  • We examined the spatiotemporal patterns of public sentiment and emotion over time at both national and state scales and identified 3 phases along the pandemic timeline with sharp changes in public sentiment and emotion. (
  • Because the clinical trials took place in the middle of the pandemic with many people getting exposed, it was easier for clinical trials to see if the vaccines worked or not. (
  • COVID-19 pandemic and to support clinical development and manufacture of health care products, including innovative medicines and vaccines. (
  • Achieving clinical trial research participant enrollment is essential to conducting a successful trial. (
  • [5, 6] Physician-scientists and basic/translational scientists need to work together to dispel these misconceptions so that enhanced participant enrollment can be attained, a step that is vital to conducting a successful clinical trial. (
  • Olivia Pagani, MD , of Riviera-Chablais Hospital, Rennaz, Switzerland , is the corresponding author for the Journal of Clinical Oncology article. (
  • Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB. (
  • Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (
  • Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen. (
  • Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen. (
  • Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid. (
  • The pharma and the Medicines for Malaria Venture plan to start a Phase 3 trial of a non-artemisinin combination treatment next year. (
  • Terry Horgan was the first and sole patient to have been dosed with the treatment in the trial, led by Brenda Wong, MD, at the University of Massachusetts Chan Medical School. (
  • The U.S. Food and Drug Administration (FDA) has placed on clinical hold Verve Therapeutics' Investigational New Drug application for its lead pipeline candidate VERVE-101, the first in vivo base editing therapy to reach the clinic as a potential treatment for Heterozygous Familial Hypercholesterolemia (HeFH). (
  • nausea, 6%) during dose titration and open-label treatment phases of the trial, respectively. (
  • If you've been diagnosed with a serious, complex or rare health problem, you may consider taking part in a clinical trial of a new treatment, especially if standard treatments haven't worked for you. (
  • Each phase has a different scientific goal, but the end goal of the clinical trial process is to determine whether a drug, medical device, surgical technique or other type of treatment or diagnostic tool is both safe and effective for use in humans. (
  • These trials focus on examining the safety and clinical effectiveness of a treatment. (
  • If the results of the Phase III trial are positive and show that the treatment is safe and effective, the researchers compile the data from all three trial phases and send it to the FDA for review with a request for a license for clinical use. (
  • This phase usually takes place after the treatment has been approved for standard use, with the goal of evaluating the long-term safety and effectiveness of a treatment. (
  • Double blinding refers to the participant, their doctor and researchers running the trial not knowing which treatment is received by each group until all data have been recorded. (
  • Thus, TAS-102 treatment results in massive trifluridine incorporation into DNA and in activation of similar DNA damage response pathways, which involve phosphorylation of Chk1 and cycle arrest during the G2/M-phase [2] . (
  • The study added valuable information to ongoing discussion and clinical evaluation of strategies to use less aggressive treatment for HPV-positive oropharyngeal cancer, which has a more favorable prognosis, as compared with HPV-negative disease, commented Paul M. Harari, MD, of the University of Wisconsin in Madison. (
  • It is not uncommon for a drug that seemed highly effective in the limited patient groups tested in phase II to look much less impressive under the more rigorous conditions of phase III trial Increasingly, phase III trials are being required to include a pharmacoeconomic analysis, such that not only clinical but also economic benefits of the new treatment are assessed. (
  • Methods: PRISM-2 is a 4-part, Phase 3 study that enrolled adults with PKU receiving pegvaliase treatment (initiated in a prior Phase 2 or Phase 3 study). (
  • The EMERALD trial is examining the use of a new investigational oral selective estrogen receptor degrader (SERD), elacestrant, for the treatment of women with estrogen receptor-positive/HER2-negative (ER+/HER2-) metastatic breast tumors that have progressed on prior endocrine and targeted therapies. (
  • Lip-AmB 0.4% alone or in combination with national standard treatment is safe with high-efficacy rate and warrants further investigation during phase 3 clinical trials. (
  • The latest breakthrough in amyotrophic lateral sclerosis (ALS) research recently came out of Israel after a leading developer of adult stem cell technologies for neurodegenerative diseases announced positive results from a clinical trial of a potential treatment. (
  • On ALSFRS, NurOwn slowed the rate of progression by 45%, from 1.41 points per months during the run-in period to 0.78 points per months for the 3 months following treatment. (
  • The rate of decline in percent-predicted FVC was reduced by 73%, from an average of 2.60% per month during the run-in period to 0.70% per month for the 3 months after treatment, and by 67% to 0.86% per month for the 6 months following treatment. (
  • But systems design and provider adherence to guidelines are topics worthy of extensive separate treatment and are not dealt with here. (
  • Sinocelltech Group Ltd. has reported positive interim data for two COVID-19 vaccine candidates, SCTV-01C and SCTV-01E, from phase III trials in the United Arab Emirates. (
  • The trial will continue towards final analysis including the 6-month safety data. (
  • The whole process has to comply with an elaborate code known as Good Clinical Practice, covering every detail of the patient group, data collection methods, recording of information, statistical analysis and documentation. (
  • Moderna released data from a Phase 2-3 clinical trial showing its bivalent COVID-19 booster shot performed better against the BA.4 and BA.5 omicron subvariants. (
  • The EUA submission also included data from the randomized, controlled, phase 2 COV-BOOST trial. (
  • The work involves using clinical trial data with mathematical and statistical models. (
  • Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (
  • This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to. (
  • Moreover, the ability to quickly and flexibly respond to new pre-clinical and clinical data allows us to modify our phage cocktails accordingly. (
  • Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialized applications. (
  • Moreover rising number of Adverse drug reaction is a major concern of the pharmacovigilance field and will contribute to significant increase in the demand for clinical data management services over the forecast period. (
  • The Phase 3 trial is expected to start in 2023 and will compare the ganaplacebide/lumefantrine combination against a standard artemether/lumefantrine combination. (
  • [3] In 2018, financial experts estimated that the collagen market accounted for nearly $3.5 billion and will likely reach $4.6 billion by 2023, in large part due to the rising demand in the medical and healthcare industries. (
  • In an earlier Phase 2 study of 524 adults and children with acute uncomplicated malaria, the once-daily combination of ganaplacide and lumefantrine led to similar response rates as twice-daily artemether and lumefantrine. (
  • Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. (
  • During the 1990s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. (
  • It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. (
  • From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors perspectives. (
  • Laboratory-confirmed leptospirosis was defined as a fourfold rise in MAT titers between acute- and convalescent-phase serum specimens against Leptospira serovars. (
  • One case-patient submitted only an acute-phase serum specimen, which was negative by both MAT and IgM ELISA. (
  • however, medical researchers, institutions, and regulatory agencies are working to ensure that gene therapy research, clinical trials, and approved treatments are as safe as possible. (
  • Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. (
  • Researchers at Mayo Clinic, who conducted one of those clinical. (
  • The researchers found that over a 15 year time horizon in moderate to high transmission settings, an average of 116,500 cases of clinical malaria disease and 484 deaths would be averted for every 100,000 children vaccinated under a four-dose schedule [ more ]. (
  • In the phase 2 trial, researchers measured the safety and immune response of three different dose regimens of TAK-003 in 1,800 children 2 to 17 years old from December 2014 to February 2015 at three centers in the Dominican Republic, Panama, and the Philippines. (
  • Rather than stop a trial, discard the results and start over, researchers complete a trial anyway, knowing that there may be a better way to use the drug. (
  • Doctors, or teams of researchers, can then think up the best combinations for each individual patient, and test them in small, fast, inexpensive (or free) virtual trials. (
  • Building capacity for scientifically valid and ethically acceptable clinical trials of vaccines in Africa. (
  • Sustaining and/or building partnerships for vaccine research and development in order to conduct vaccine clinical trials and accelerate the introduction of new vaccines in Africa. (
  • We investigated the spatiotemporal trends of public sentiment and emotion towards COVID-19 vaccines and analyzed how such trends relate to popular topics found on Twitter. (
  • Malaria vaccines are potential new tools in combating malaria by targeting several different stages of the parasite lifecycle to prevent infection and clinical disease, or to block malaria transmission. (
  • The authors and editors are to be commended for bringing each of the key topics relevant to HIV vaccines to the reader in a highly accessible form. (
  • Like all vaccines, COVID-19 vaccines go through a rigorous, multi-stage testing process, including large (phase III) trials that involve tens of thousands of people. (
  • Clinical trials have indicated that mRNA vaccines provide a long-lasting immune response. (
  • While trials have indicated that several COVID-19 vaccines to have high levels of efficacy, like all other vaccines, COVID-19 vaccines are not 100% effective against the disease. (
  • Allen also cited the clinical hold placed on Verve Therapeutics' lead therapeutic by the FDA (See brief below), and a regulatory delay announced by Beam Therapeutics (See brief below). (
  • Clinical Therapeutics , 41 (12), 2571-2592. (
  • The first gene therapy trial was run more than thirty years ago. (
  • NIH provides guidelines for investigators and institutions (such as universities and hospitals) to follow when conducting clinical trials with gene therapy. (
  • An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. (
  • Methods: This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. (
  • The primary outcome was survival without IMV between day 3 and day 29, with COVID-19-related mortality as the secondary outcome. (
  • We demonstrate the relationship of these features with clinical outcome and show that integration of 186 distinct recurrent genomic alterations defines five genomic subgroups that associate with response to therapy. (
  • However, the question is this: is it worth the added toxicities to choose an oral drug over intramuscular injections when the clinical outcome is the same. (
  • The majority of solicited adverse events were mild or moderate and resolved within 3 days. (
  • No grade ≥3 late adverse events occurred, and global quality of life improved from pretreatment to 2 years. (
  • In addition, the site provides listings and information on trials sponsored by other federal agencies, the medical industry (including pharmaceutical companies), university and healthcare organizations. (
  • Given that pharmaceutical companies retain exclusive intellectual property over their products, and owing to infrastructure challenges, most poor countries won't be widely vaccinated for another 3 years . (
  • The NextDocs Electronic Trial Master File (eTMF) along with Trial Exchange (TrX) help pharmaceutical companies to streamline processes, improve transparency and quality, automate information exchange, and reduce the administrative overhead associated with running clinical trials. (
  • This Global Fortune 500 pharmaceutical company, one of the ten largest pharmaceutical companies in the world, initially deployed the NextDocs eTMF solution over two years ago to manage clinical trial documents. (
  • More than 100 life sciences companies rely on NextDocs solutions, including 5 of the top 10 pharmaceutical companies and two of the largest Clinical Research Organizations (CROs). (
  • Novavax has announced positive results of their phase 3 PREVENT-19 clinical trial (NCT04511802) evaluating the company's recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373. (
  • The company's European sites are capable of Phase III and commercial production. (
  • The new facility will support clinical manufacturing of the company's phage products and has the capability to be expanded in the future to support commercial manufacturing needs. (
  • In its current configuration, the facility can support clinical manufacturing for the company's future Phase I and Phase II trials in both IBD and primary sclerosing cholangitis (PSC). (
  • All regulatory guidelines will be followed to conduct the multi-centric, Phase III clinical trials, the Dalmia Group firm said in a statement. (
  • Such events may necessitate limiting the use of the drug to particular patient groups, or even withdrawal of the drug Preclinical trials: Before conducting clinical trials every new drug should undergo pre-clinical trials to check whether it is safe to conduct clinical trials in human subjects or not. (
  • We also know that a phase III trial, although challenging to organize and conduct among persons at high risk, is doable. (
  • There was also a significant 30% to 35% reduction in the key secondary endpoint of new clinical relapse or lesion on MRI with both doses. (
  • The 12 week, randomized clinical trial evaluated ostarine 3 mg and two doses of mk-3984. (
  • Providing guidelines and standards for vaccine clinical trials in Africa. (
  • Inadequate funding for R & D: Vaccine clinical trials require substantial financial resources which is not readily available in many cases. (
  • The NextDocs eTMF solution provides a clinical collaboration platform for managing trial documentation that incorporates best practices in document management from across the life sciences industry. (
  • Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug. (
  • Each chapter, written by experts in each field, is impressive in its balance of compactness (3-4 double-sided pages, including references), technical content, and user-friendliness (abstract and conclusion for each chapter make quick review easy). (
  • Novartis and the research foundation Medicines for Malaria Venture plan to advance a new kind of malaria drug into late-stage clinical testing in adults and children next year. (
  • This article was originally published by sister publication Drug Topics. (
  • 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. (
  • Dr Sartor and colleagues recently published the results of a phase 2, single-arm study that evaluated the use of radium-223 in an expanded access program (EAP) that provided early access to radium-223 after the positive results from ALSYMPCA, but before commercial availability of the drug. (
  • 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. (
  • Clinical trials are the tests conducted on human subjects to test the safety, efficacy, tolerability, and phamaco-kinetic properties of the drug. (
  • Phase I trials are performed on a small group (normally 20-80) of normal healthy volunteers, and their aim is to check for safety (does the drug produce any potentially dangerous effects, for example on cardiovascular, respiratory, hepatic or renal function? (
  • When new drug targets are being studied, it is not until these phase II trials are completed that the team finds out whether or not its initial hypothesis was correct, and lack of the expected efficacy is a common reason for failure. (
  • At the end of phase III, the drug will be submitted to the relevant regulatory authority for licensing. (
  • In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. (
  • However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization (WHO), did not show any benefit of the drug in reducing COVID deaths. (
  • A recent phase 2b trial of more than 4500 individuals across three continents found that an experimental monoclonal antibody drug, VRC01, effectively prevented 75% of infections from HIV-1 isolates sensitive to that antibody. (
  • Takeda is taking the same approach Sanofi did with clinical trials-by testing it in tropical countries for safety and immune response before trying to get approval of the vaccine by Western regulatory agencies like the US Food and Drug Administration (FDA). (
  • The existing drug development system "has failed miserably" for people with glioblastoma brain tumors, according to Al Musella, DPM, President of the Musella Foundation for Brain Tumor Research & Information, Inc. In partnership with Cancer Commons, his organization's Brain Tumor Virtual Trial aims to speed discovery of promising new glioblastoma treatments. (
  • The Virtual Trial system should keep drug costs down, as it will take the vast majority of time and money out of the drug development process and break the monopolies currently preventing many new drugs from being developed. (
  • The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. (
  • Int. Ed. Dr. Cheng is currently the Editorial Board Member of Letters in Drug Design & Discovery, and the guest editor of Topics in Current Chemistry. (
  • The drug is administered intravenously every two weeks, and its administration requires a dose escalation phase followed by a maintenance phase. (
  • Drug-induced conjunctivitis has been observed in clinical trials of dupilumab, a therapy that blocks interleukin (IL)-4 and IL-13 signalling via IL-4 receptor (IL-4R)α, [ 5 , 6 ] and has been suggested to be a drug-disease interaction. (
  • The new facility has been designed to support the necessary manufacturing requirements for BiomX's future clinical development, including the manufacturing of BX002, a drug candidate phage cocktail designed to target bacterial strains that potentially have a role in the onset and aggravation of inflammatory bowel disease (IBD). (
  • The average cost of bringing a new drug to market is $1.3 billion, with approximately 90% of that expense associated with Phase III trials. (
  • However adverse drug reaction (ADR) is an undesirable and unwanted effect of a medication that occurs during its clinical use. (
  • For example, the United States Food and Drug Administration and the European Medicines agency form regulatory guidelines for different phases of clinical trials. (
  • The "excellent clinical outcomes," including survival and quality of life, extended an ongoing clinical collaboration between UNC and the University of Florida, evaluating reduced-dose radiation therapy protocols. (
  • In the last 25 years, only one phase 3 glioblastoma study showed a statistically significant improvement in survival, adding only 3 months to median survival. (
  • [3] The underlying mechanism involves immunoglobulin E antibodies (IgE), part of the body's immune system, binding to an allergen and then to a receptor on mast cells or basophils where it triggers the release of inflammatory chemicals such as histamine . (
  • ABP 300 recently completed a phase I dose escalation study in human subjects. (
  • The 27-year-old brother of Cure Rare Disease founder and CEO Rich Horgan has died while participating in a clinical trial sponsored by the nonprofit organization to study a CRISPR gene-editing therapeutic. (
  • Verve, a developer of gene editing therapies for cardiovascular disease, did not detail what led to the clinical hold, only saying that it expected to receive a formal letter with questions from the FDA within 30 days of the agency's notification to the company, which occurred November 4. (
  • An external panel of experts convened by WHO analyzes the results from clinical trials, along with evidence on the disease, age groups affected, risk factors for disease, and other information. (
  • ASMD, which represents a spectrum of disease, is classified into three categories: type A, type B, and type A/B. Type A and type B sit on opposite ends of the spectrum, whereas A/B is an intermediate form. (
  • obesity will need alignment of the intensity of therapy with the severity of disease and integration of therapy with Sumner M Redstone Global environmental changes that reinforce clinical strategies. (
  • Topical nanoliposomes containing 0.4% amphotericin B (Lip-AmB 0.4%) have shown promising safety re- sults in preclinical and phase 1 clinical trials in healthy volunteers. (
  • Its incidence is increasing, so it is important to include new and relevant evidence in clinical practice guidelines. (
  • Is reading this article likely to improve your clinical practice? (
  • I just don't understand how this trial is supposed to inform clinical practice. (
  • These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. (
  • The editors were careful to include chapters on important nonscientific aspects of HIV vaccine development, such as clinical site development, regulatory issues, scale-up, and manufacturing. (
  • Our research team will enroll a large number of volunteers into this extremely important vaccine trial. (
  • 3 Some research also suggests that these IUDs maintain their effectiveness up to a year beyond their recommended use period. (
  • These guidelines state that clinical trials at institutions receiving NIH funding for this type of research must be registered with the NIH Office of Biotechnology Activities. (
  • 3,4] Despite the bene ts of clinical research, many people approached to participate decline to do so because of deeply rooted myths about research. (
  • 5] The philosophical underpinnings of conducting clinical trial research are centered around three basic ethical principles: Respect for Persons, Bene cence, and Justice. (
  • This research study is a randomized doubleblind controlled clinical trial that tests the efficacy of higher-strength as compared to low-strength/standard of care folic acid to prevent fetal body and brain size reduction in pregnant women who smoke. (
  • Omnibus solicitations are structured to be broad, extensive Programmatic issuances with research areas related to the petitioning Agency and are not limited to predetermined Topics/Subtopics. (
  • The trial was conducted by MAPS Public Benefit Corporation , a for-profit subsidiary launched by the registered non-profit in 2014, with the goal of conducting the necessary research to make MDMA a legally available medicine. (
  • Clinical Cancer Research , 20 (16), 4210-4217. (
  • Here we offer advice and information to help you determine whether your research is considered human subjects, and if it is, how to understand and comply with regulations at all phases of application and award, including NIAID requirements. (
  • Learn more on NIAID's Clinical Trial Research page. (
  • In 2013, the company expanded the deployment to include Clinical Research Organization (CRO) access. (
  • Understanding the Impact of GDPR on Clinical Research . (
  • How might your Virtual Trial approach speed the process toward either validating or invalidating potential therapies for glioblastoma? (
  • The safety and tolerability profile of LYNPARZA in SOLO3 was consistent with previous trials. (
  • The protocol, or plan, for each clinical trial is then reviewed by the NIH Recombinant DNA Advisory Committee (RAC) to determine whether it raises medical, ethical, or safety issues that warrant further discussion at a RAC public meeting. (
  • The safety profile is consistent with results from the Phase 1 clinical trial. (
  • These trials, which include some groups at high risk for COVID-19, were specifically designed to identify any common side effects or other safety concerns. (
  • In a phase 3 trial, Merck & Co's experimental medication, molnupiravir, was effective against all known coronavirus variants , including Delta. (
  • The phase 1 horror story that stays most in British minds is the cytokine storm, which hit six volunteers 10 years ago at Northwick Park when they were given an agent called TGN1412. (
  • Properties of abuse-deterrent hydrocodone ER were tested in 182 adults (136 of whom completed the study) experiencing moderate-to-severe back pain for more than 3 months and who had previously been enrolled in the 12 week-long RCT. (
  • These trials are usually small and use healthy adults as test subjects. (
  • Later, children also may get the trial vaccine, if it is intended for them, after it is first tested in adults. (
  • Objective: Determine the clinical predictors of decline in early treated PD using a novel multi-domain measure. (
  • It is advisable to create a list of the details of your diagnosis and treatments to date before looking for trials for which you qualify. (
  • Your doctors are also a good starting point for finding a trial that fits your diagnosis and specific needs. (
  • The study population had relatively high baseline CD4 counts (a median of 440 cells/mm 3 ), reflecting the trend towards earlier diagnosis. (
  • Disclosure: This clinical trial was supported by Sanofi and Regeneron Pharmaceuticals. (
  • Takeda's product is the second dengue vaccine to enter clinical trials, after Sanofi Pasteur's Dengvaxia. (
  • Novavax announces positive results of COVID-19 vaccine in pediatric population of PREVENT-119 phase 3 clinical trial. (
  • In clinical trials, this vaccine was 66% effective in preventing the COVID-19 virus with symptoms - as of 14 days after vaccination. (
  • The clinical trial process occurs in three phases. (
  • What occurs during a clinical trial depends on what phase the trial is in. (
  • Third, the PhagoBurn clinical study, representing the world first phage therapy clinical trial using GMP produced phage cocktails, was launched in July 2015 and ended in January 2017. (
  • If you do not find what you're looking for, search for other Phase III trials, then Phase II, then Phase I. (For information about clinical trial phases, click here . (
  • Articles by Country Search - Search articles by the topic country. (
  • Results of search for 'ccl=su:{Clinical trials, Phase II. (
  • Your search returned 3 results. (
  • Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. (
  • None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. (
  • Select up to three search categories and corresponding keywords using the fields to the right. (
  • Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers, which includes KEYNOTE-811 in first-line advanced HER2-positive gastric cancer, KEYNOTE-585 in early-stage gastric cancer, and further exploration in advanced/metastatic gastric cancer in LEAP-015. (
  • The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. (
  • Despite years of preclinical development, biological interventions designed to treat complex diseases such as asthma often fail in phase III clinical trials. (
  • This demonstration provides insights to help translational teams overcome theoretical, practical, and pedagogical hurdles for the widespread use of subject-protein networks for analyzing molecular heterogeneities, with the translational goal of designing biomarker-based clinical trials, and accelerating the development of personalized approaches to medicine. (
  • The authors suggest three main theories to explain the development of the syndrome: genetic predisposition, silicone bleeding and the formation of a periprosthetic capsule. (
  • German contract development and manufacturing organisation (CDMO) Vetter has built a facility for pre-clinical and clinical syringe filling in Chicago. (
  • The early-stage development site within the Illinois Science and Technology Park can now handle sterile injectable projects from pre-clinical to Phase II. (
  • Vetter said its syringe-filling operations will allow customers to use their final packaging material during clinical stage production, meaning they can plan their commercial launch strategy in the early development phase. (
  • In this new age of live biotherapeutics, which include phage as well as human-derived cells and bacteria, manufacturing has become a major step on the path to clinical development," said Jonathan Solomon, BiomX's CEO, in a company press release. (
  • [3] Their development is due to both genetic and environmental factors. (
  • In addition to this increasing advancement in targeted drugs such as new clinical trial phase development will further propel demand for pharmacovigilance services in the coming years. (