Clinical Trials as Topic: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.Clinical Trials, Phase II as Topic: Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Clinical Trials, Phase III as Topic: Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Antineoplastic Combined Chemotherapy Protocols: The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.Clinical Trials, Phase I as Topic: Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.Research Design: A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.Metabolic Detoxication, Phase II: The conjugation of exogenous substances with various hydrophilic substituents to form water soluble products that are excretable in URINE. Phase II modifications include GLUTATHIONE conjugation; ACYLATION; and AMINATION. Phase II enzymes include GLUTATHIONE TRANSFERASE and GLUCURONOSYLTRANSFERASE. In a sense these reactions detoxify phase I reaction products.Antineoplastic Agents: Substances that inhibit or prevent the proliferation of NEOPLASMS.Double-Blind Method: A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.Randomized Controlled Trials as Topic: Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.Controlled Clinical Trials as Topic: Works about clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.Infusions, Intravenous: The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.Neoplasms: New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.Disease-Free Survival: Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.DeoxycytidinePatient Selection: Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.Drug Evaluation: Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.Survival Analysis: A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.Time Factors: Elements of limited time intervals, contributing to particular results or situations.Paclitaxel: A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.Multicenter Studies as Topic: Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children.Follow-Up Studies: Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.Cisplatin: 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.Combined Modality Therapy: The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used.Dose-Response Relationship, Drug: The relationship between the dose of an administered drug and the response of the organism to the drug.Survival Rate: The proportion of survivors in a group, e.g., of patients, studied and followed over a period, or the proportion of persons in a specified group alive at the beginning of a time interval who survive to the end of the interval. It is often studied using life table methods.Prospective Studies: Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.Taxoids: 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.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Placebos: Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.Lung Neoplasms: Tumors or cancer of the LUNG.Disease Progression: The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.Clinical Protocols: Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.Antibodies, Monoclonal, Humanized: Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.Clinical Trials, Phase IV as Topic: Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.Endpoint Determination: Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.Maximum Tolerated Dose: 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)Clinical Trials Data Monitoring Committees: Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.Antineoplastic Agents, Phytogenic: Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity.Neoplasm Metastasis: The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.Camptothecin: 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.Organoplatinum Compounds: Organic compounds which contain platinum as an integral part of the molecule.Neoplasm Recurrence, Local: The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site.Neoplasm Staging: Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.Single-Blind Method: A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.Sample Size: The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95)Evidence-Based Medicine: An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)Breast Neoplasms: Tumors or cancer of the human BREAST.Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.Drug Therapy, Combination: Therapy with two or more separate preparations given for a combined effect.Pilot Projects: Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.Quality of Life: A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.Carboplatin: An organoplatinum compound that possesses antineoplastic activity.United StatesAntibodies, Monoclonal: Antibodies produced by a single clone of cells.Carcinoma, Non-Small-Cell Lung: 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.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Feasibility Studies: Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.Early Termination of Clinical Trials: Earlier than planned termination of clinical trials.Antimetabolites, Antineoplastic: Antimetabolites that are useful in cancer chemotherapy.Kaplan-Meier Estimate: A nonparametric method of compiling LIFE TABLES or survival tables. It combines calculated probabilities of survival and estimates to allow for observations occurring beyond a measurement threshold, which are assumed to occur randomly. Time intervals are defined as ending each time an event occurs and are therefore unequal. (From Last, A Dictionary of Epidemiology, 1995)LeukopeniaNausea: 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.Congresses as Topic: Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.Vinblastine: Antitumor alkaloid isolated from Vinca rosea. (Merck, 11th ed.)Salvage Therapy: A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.Prognosis: A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.Recurrence: The return of a sign, symptom, or disease after a remission.QuinazolinesDacarbazine: An antineoplastic agent. It has significant activity against melanomas. (from Martindale, The Extra Pharmacopoeia, 31st ed, p564)Doxorubicin: Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.Guidelines as Topic: A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.Severity of Illness Index: Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.Remission Induction: Therapeutic act or process that initiates a response to a complete or partial remission level.Leucovorin: The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.Drugs, Investigational: Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.Questionnaires: Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Review Literature as Topic: Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.Meta-Analysis as Topic: A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.Chemotherapy, Adjuvant: Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.Research Subjects: Persons who are enrolled in research studies or who are otherwise the subjects of research.Outcome Assessment (Health Care): Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).Antineoplastic Agents, Alkylating: 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)Risk Assessment: The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)Medical Oncology: A subspecialty of internal medicine concerned with the study of neoplasms.Benzenesulfonates: Organic salts and esters of benzenesulfonic acid.Patient Education as Topic: The teaching or training of patients concerning their own health needs.Risk Factors: An aspect of personal behavior or lifestyle, environmental exposure, or inborn or inherited characteristic, which, on the basis of epidemiologic evidence, is known to be associated with a health-related condition considered important to prevent.Drug Resistance, Neoplasm: Resistance or diminished response of a neoplasm to an antineoplastic agent in humans, animals, or cell or tissue cultures.Practice Guidelines as Topic: Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.Cost-Benefit Analysis: A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.Colorectal Neoplasms: 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.Brain Neoplasms: 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.Thrombocytopenia: A subnormal level of BLOOD PLATELETS.Phenylurea Compounds: Compounds that include the amino-N-phenylamide structure.Treatment Failure: A measure of the quality of health care by assessment of unsuccessful results of management and procedures used in combating disease, in individual cases or series.Drug Combinations: Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.Cyclophosphamide: 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.Reproducibility of Results: The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.Niacinamide: 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.Abstracting and Indexing as Topic: Activities performed to identify concepts and aspects of published information and research reports.Epothilones: A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).Patient Compliance: Voluntary cooperation of the patient in following a prescribed regimen.Etoposide: 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.Angiogenesis Inhibitors: Agents and endogenous substances that antagonize or inhibit the development of new blood vessels.Drug-Related Side Effects and Adverse Reactions: Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.Safety: Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.Melanoma: 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)Neoadjuvant Therapy: Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.Tegafur: Congener of FLUOROURACIL with comparable antineoplastic action. It has been suggested especially for the treatment of breast neoplasms.Vomiting: The forcible expulsion of the contents of the STOMACH through the MOUTH.Data Interpretation, Statistical: Application of statistical procedures to analyze specific observed or assumed facts from a particular study.Informed Consent: Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.Ovarian Neoplasms: 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.Textbooks as Topic: Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.Research Support as Topic: Financial support of research activities.Prostatic Neoplasms: Tumors or cancer of the PROSTATE.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.Dietary Supplements: Products in capsule, tablet or liquid form that provide dietary ingredients, and that are intended to be taken by mouth to increase the intake of nutrients. Dietary supplements can include macronutrients, such as proteins, carbohydrates, and fats; and/or MICRONUTRIENTS, such as VITAMINS; MINERALS; and PHYTOCHEMICALS.Intention to Treat Analysis: Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.Protein Kinase Inhibitors: Agents that inhibit PROTEIN KINASES.Hematologic Diseases: Disorders of the blood and blood forming tissues.Oxonic Acid: Antagonist of urate oxidase.Coxiella: A genus of gram-negative, rod-shaped bacteria that is widely distributed in TICKS and various mammals throughout the world. Infection with this genus is particularly prevalent in CATTLE; SHEEP; and GOATS.Pain Measurement: Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.Drug Industry: That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.Pyridines: Compounds with a six membered aromatic ring containing NITROGEN. The saturated version is PIPERIDINES.Area Under Curve: A statistical means of summarizing information from a series of measurements on one individual. It is frequently used in clinical pharmacology where the AUC from serum levels can be interpreted as the total uptake of whatever has been administered. As a plot of the concentration of a drug against time, after a single dose of medicine, producing a standard shape curve, it is a means of comparing the bioavailability of the same drug made by different companies. (From Winslade, Dictionary of Clinical Research, 1992)Pyrroles: Azoles of one NITROGEN and two double bonds that have aromatic chemical properties.Placebo Effect: An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.Patient Participation: Patient involvement in the decision-making process in matters pertaining to health.Cross-Over Studies: Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)Epirubicin: 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.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Ifosfamide: Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.Vincristine: An antitumor alkaloid isolated from VINCA ROSEA. (Merck, 11th ed.)Benchmarking: Method of measuring performance against established standards of best practice.Immunotherapy: Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.Terminology as Topic: The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.Kidney Neoplasms: Tumors or cancers of the KIDNEY.PyrazinesStroke: 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)NAD(P)H Dehydrogenase (Quinone): A flavoprotein that reversibly catalyzes the oxidation of NADH or NADPH by various quinones and oxidation-reduction dyes. The enzyme is inhibited by dicoumarol, capsaicin, and caffeine.Random Allocation: A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.Phytotherapy: Use of plants or herbs to treat diseases or to alleviate pain.Publishing: "The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing.Biological Markers: Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc.Pyrimidines: A family of 6-membered heterocyclic compounds occurring in nature in a wide variety of forms. They include several nucleic acid constituents (CYTOSINE; THYMINE; and URACIL) and form the basic structure of the barbiturates.Stomach Neoplasms: Tumors or cancer of the STOMACH.HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).Injections, Intravenous: Injections made into a vein for therapeutic or experimental purposes.Peritoneal Neoplasms: Tumors or cancer of the PERITONEUM.Cancer Vaccines: Vaccines or candidate vaccines designed to prevent or treat cancer. Vaccines are produced using the patient's own whole tumor cells as the source of antigens, or using tumor-specific antigens, often recombinantly produced.Interviews as Topic: Conversations with an individual or individuals held in order to obtain information about their background and other personal biographical data, their attitudes and opinions, etc. It includes school admission or job interviews.Molecular Targeted Therapy: Treatments with drugs which interact with or block synthesis of specific cellular components characteristic of the individual's disease in order to stop or interrupt the specific biochemical dysfunction involved in progression of the disease.Recombinant Proteins: Proteins prepared by recombinant DNA technology.Tumor Markers, Biological: 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.Carcinoma, Renal Cell: A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.Exercise Therapy: A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.Retrospective Studies: Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.Head and Neck Neoplasms: 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)Carcinoma, Squamous Cell: A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)Patient Satisfaction: The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial.Acute Disease: Disease having a short and relatively severe course.Diarrhea: An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.Pain: An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.National Institutes of Health (U.S.): An operating division of the US Department of Health and Human Services. It is concerned with the overall planning, promoting, and administering of programs pertaining to health and medical research. Until 1995, it was an agency of the United States PUBLIC HEALTH SERVICE.Analysis of Variance: A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.Predictive Value of Tests: In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.National Cancer Institute (U.S.): Component of the NATIONAL INSTITUTES OF HEALTH. Through basic and clinical biomedical research and training, it conducts and supports research with the objective of cancer prevention, early stage identification and elimination. This Institute was established in 1937.Liver Neoplasms: Tumors or cancer of the LIVER.Antibodies, Monoclonal, Murine-Derived: Antibodies obtained from a single clone of cells grown in mice or rats.Bridged Compounds: Cyclic hydrocarbons that contain multiple rings and share one or more atoms.Bias (Epidemiology): Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.Pancreatic Neoplasms: Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).Probability: The study of chance processes or the relative frequency characterizing a chance process.Cohort Studies: Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.Injections, Subcutaneous: Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin.Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.Drug Evaluation, Preclinical: Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.Therapeutic Human Experimentation: Human experimentation that is intended to benefit the subjects on whom it is performed.Antibiotics, Antineoplastic: Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms.Anthracyclines: Organic compounds that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine.Internet: A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.Carcinoma, Small Cell: 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)Indoles: Benzopyrroles with the nitrogen at the number one carbon adjacent to the benzyl portion, in contrast to ISOINDOLES which have the nitrogen away from the six-membered ring.Radiotherapy, Adjuvant: 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.Boronic Acids: Inorganic or organic compounds that contain the basic structure RB(OH)2.Sarcoma: A connective tissue neoplasm formed by proliferation of mesodermal cells; it is usually highly malignant.EuropeMethotrexate: 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.ThiophenesEstramustine: A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.Chronic Disease: Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)Glioblastoma: A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures.

Incremental costs of enrolling cancer patients in clinical trials: a population-based study. (1/883)

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)

Development of difluoromethylornithine (DFMO) as a chemoprevention agent. (2/883)

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

Preclinical and early clinical development of keratinocyte growth factor, an epithelial-specific tissue growth factor. (3/883)

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

Safety and tolerability of fluconazole in children. (4/883)

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)

The induction of spermidine/spermine N1-acetyltransferase (SSAT) is a common event in the response of human primary non-small cell lung carcinomas to exposure to the new antitumor polyamine analogue N1,N11-bis(ethyl)norspermine. (5/883)

Several new polyamine analogues have been developed for the treatment of human solid tumors. The phenotype-specific activity of some of these analogues has been associated with the superinduction of the rate-limiting enzyme in polyamine catabolism spermidine/spermine N1-acetyltransferase (SSAT). Using immunohistochemistry, we found a majority (64%) of human primary lung cancer explants to exhibit high expression of SSAT after treatment with 10 microM N1,N11-bis(ethyl)norspermine, an agent currently undergoing Phase II clinical trials against several important human solid tumors. The staining of SSAT was found specifically in the tumor tissue and not in the neighboring normal lung tissue. These results demonstrate the ability to detect induction of SSAT in clinical specimens and suggest the potential of this test as a prognostic indicator of drug response.  (+info)

Progressive disease rate as a surrogate endpoint of phase II trials for non-small-cell lung cancer. (6/883)

BACKGROUND: Although the potential activity of anticancer agents has been traditionally assessed by the response rate (RR) in phase II trials, there is an increasing need to identify alternative endpoints to evaluate the efficacy of novel types of antineoplastic agents such as cytostatic agents. However, none of the proposed alternatives have been validated. DESIGN: RR, rate of progressive disease (PD), and median survival time (MST) were obtained from 44 treatment arms in 42 single-agent phase II trials for non-small-cell lung cancer (NSCLC). Correlations between these parameters and their significance in selection of promising drugs were evaluated. RESULTS: The median (range) RR and PD rate per treatment arm were 17% (0%-40%) and 41% (8%-93%), respectively. The PD rate correlated more closely with MST (correlation coefficient (r) = 0.80, P < 0.001) than did the RR (r = 0.62, P < 0.001). The RR of active agents against NSCLC ranged broadly from 7% to 40%, whereas their PD rates were all 50% or less. In addition, all treatment arms with a PD rate over 50% had a poor MST of six months or shorter. CONCLUSIONS: The PD rate was potentially as good an endpoint as RR, and it may be a good candidate for the primary endpoint of phase II trials for novel types of anticancer agents.  (+info)

Valuing clinical strategies early in development: a cost analysis of allogeneic peripheral blood stem cell transplantation. (7/883)

Allogeneic peripheral blood stem cell transplantation (alloPBSCT) is an emerging technology. As this technology develops, transplant centers are concerned with looking for technologic advances that will result in improvements in clinical outcomes and lower costs. We provide comparative estimates of costs and resource use for alloPBSCT in comparison to allogeneic bone marrow transplantation (alloBMT) for persons with hematologic malignancies from the time of harvest to 100 days post transplant. A retrospective, cost-identification analysis was conducted for patients in two consecutive phase II clinical trials at the University of Nebraska Medical Center. Identical preparative regimens, graft-versus-host disease prophylaxis, post-transplant hematopoietic colony-stimulating factor treatment regimens, and discharge criteria were used. Total median costs were $18,304 lower for alloPBSCT, with lower costs during recovery; specifically for hospitalization, platelet products, hematopoietic growth factors, intravenous hyperalimentation, supportive care agents, supplies, and antibacterial agents. This study provides preliminary evidence for short-term cost savings associated with alloPBSCT. However, concerns exist over the potential for higher costs due to preliminary reports of higher rates of chronic graft-versus-host disease, as well as more intensive induction regimens that may result in lower relapse rates. The premature adoption of new technologies based on short-term economic factors, in the absence of adequate clinical trial data, may prove to be ill-advised, particularly for complex medical treatments such as allogeneic transplantation.  (+info)

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. (8/883)

PURPOSE: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (AIPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AIPC to define these parameters. RESULT: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. CONCLUSION: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.  (+info)

Chi-Med highlights publication of Phase II data showing promising efficacy for Savolitinib in MET-amplified gastric cancers - read this article along with other careers information, tips and advice on BioSpace
Allergan Reports Topline Phase II Data Supporting Advancement of BOTOX® (onabotulinumtoxinA) for the Treatment of Major Depressive Disorder (MDD)
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
This study investigated the efficacy, tolerability and effects on immune reconstitution of daclizumab for the prevention of graft versus host disease in
Cancer forums by research scientists for patients. Discussing any cancer Mesothelioma, Leukemia, Prostate, Myeloma, Breast Cancer, Colon, Pancreatic
NVA237 demonstrated sustained 24-hour bronchodilation with efficacy comparable to tiotropium and potentially faster onset of action 1 Data show NVA237 was well
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.
The Journal of Alzheimers Disease has published today the results of the first clinical trial of a Tau Aggregation Inhibitor (TAI) in Alzheimers disease (AD).1 This Phase II clinical trial, conducted by TauRx Therapeutics Ltd (a Singapore incorporated spinout from the University of Aberdeen), provided the basis and rationale for subsequent Phase III clinical trials of a TAI in AD currently in progress. The double-blind dose-finding Phase II clinical trial involved 321 patients in 16 clinical research centres in the UK and one centre in Singapore and tested three doses of the drug. The study met its predefined primary efficacy endpoint at 24 weeks on the standard scale most commonly used to measure cognitive decline in clinical trials (ADAS-cog) at the 138 mg / day dose. The primary result was also supported by benefit on two other clinical scales. The effect sizes seen were statistically significant and clinically meaningful in moderate subjects at 24 weeks. The clinical results were also ...
SUNNYVALE, Calif., May 31, 2015 /PRNewswire/ -- Ibrutinib (IMBRUVICA®) Phase Ib/II Data Show Promise in Patients with Chronic Graft-Versus-Host-Disease....
This randomized phase II/III trial studies how well giving combination chemotherapy with or without rituximab works in treating younger patients with st
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). ...
Positive interim results prompt request for meeting with FDA Cell Therapeutics, Inc. (CTI) announced today that interim results of its phase II III trial compar
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
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...
Excerpt:. "The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) was highly effective as a treatment for patients with BRAF V600E-mutant non-small cell lung cancer (NSCLC), according to lead investigator David Planchard MD, PhD, who presented the phase II data at the 2016 ASCO Annual Meeting.1 Findings from the study were also concurrently published in Lancet Oncology.2. "The investigator assessed objective response rate (ORR) with the combination was 63% (95% CI, 49-75), which lasted for a median duration of 9.0 months (95% CI, 6.9-18.3). When adding those with stable disease for ≥12 weeks, the overall disease control rate was 79% (95% CI, 66-89). The median progression-free survival (PFS) was 9.7 months (95% CI, 6.9-19.6).. "In addition to the combination cohort, the study also included a single-agent arm that included 78 previously treated patients with metastatic BRAF V600E-mutant NSCLC. In this cohort, the ORR with single-agent dabrafenib was 33% and the median PFS was 5.5 ...
Damian Garde Arrowhead Research watched its shares nose-dive after a peek at Phase II data on its in-development treatment for hepatitis B revealed that the RNAi therapy isnt measuring ...
Los Angeles, CA, January 18, 2019 - ImaginAb Inc., an emerging immuno-oncology imaging company, announced today the enrollment of the first patient in the Phase II clinical trial of ImaginAbs CD8+ T Cell imaging agent. The trial will enroll metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAbs CD8+ T cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies. The study is, in part, financially supported by Boehringer Ingelheim and contributes to the aims of the strategic collaboration between ImaginAb and Boehringer Ingelheim to develop ImaginAbs CD8+ T cell Immuno-PET imaging agent, IAB22M2C.. IAB22M2C is designed to be used with PET scan technology to non-invasively measure CD8+ T cell tumor infiltrates in patients with cancer, including the identification of changes in CD8+ T cell ...
Alnylam Completes Enrollment of Phase II Clinical Trial and Initiates Open-Label Extension (OLE) Study with ALN-TTR02, an RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of
Intercell AG (VSE: ICLL) today announced that its collaborator Merck & Co., Inc. has initiated a Phase II clinical trial of V710, an investigational vaccine for the prevention of Staphylococcus
While its not common for vaccine candidates that have delivered good results in early stages to fail in subsequent phases, it can happen.
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The two-stage design in a non-stringent test situation. (A) Data simulation experiment: empirical density functions of the DE genes (solid curve), noisy non-DE
Promising clinical trial drug, defactinib, is now in phase II of trials. Learn how it stops the growth of stem cells and prevents further tumor growth.
Kiadis announces that ongoing Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) data for ATIR101™ has been selected for presentation
All symptoms had positive predictive values below 1%, except for abdominal distension. These low values reflect both the high frequency of abdominal symptoms in the "healthy" population allied to the relatively low incidence of ovarian cancer. Nevertheless, a 2.5% risk of ovarian cancer with abdominal distension clearly warrants investigation. This symptom was also reported by over a third of women. Furthermore, it remained associated with cancer even when we removed the final six months from analysis. It was also equally as common in stages I and II cancer as it was in advanced cancer, as has been noted before.20 Yet, abdominal distension is not included in current guidance for urgent investigation7; if it were, some women could have their diagnosis expedited by many months.. An allied symptom is bloating. This is not a mainstream medical term in the UK, and it is likely that the records of bloating represent a verbatim note of the word the woman used. Women, however, use the term for two ...
1,155 patients have been randomized in GLADIATOR, with a retention rate of 74% of those patients 100 mg and 200 mg doses of lasmiditan collectively have been administered over 7,500 times in GLADIATOR and have been well tolerated with no significant increase in cardiovascular adverse events in patients Interim update on GLADIATOR presented at a symposium...
A discussion on the PROSPER phase III and ARAMIS phase II clinical trials.|strong|               |/strong|
Dignan, I stumbled across Transition Therapeutics (Canadian company). They have the following drug/s? in trial. Not sure if it / they are on your list? Ian Clinical Development A Phase II clinical trial is underway in MS patients with data ...
Cornerstone Pharmaceuticals gets Approval to Conduct Phase I/II Clinical Trial of CPI-613 in Cancer Patients by US FDA 25 th July 2008. Cornerstone Pharmaceuticals, Inc., a privately held pharmaceutical company, has received clearance from the US Food and Drug Administration (FDA) to begin a Phase I/II clinical trial evaluating the safety and early efficacy of its first-in-class Altered Energy Metabolism-Directed (AEMD) compound, CPI-613, in a variety of cancer types.. CPI-613 targets distinctive changes in the energy generating processes associated with the vast majority of solid tumor types, according to preclinical studies. CPI-613 has shown possible utility in multiple preclinical studies including studies conducted using human tumor biopsies from patients bearing lung, colon, pancreatic and breast tumors as well as cancer cell lines resistant to traditional chemotherapeutics.. The approved clinical trial will be open to patients with a variety of tumor types who have failed previous ...
Durham, NC, September 18, 2012 /PRNewswire/ - CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administrations Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies: 1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans. The development program will be confirmed via the Special Protocol Assessment process.. Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a ...
TxCell Presents Final Positive Results of the Phase I/II Clinical Trial With Antigen-Specific Treg Cells in Crohns Disease - read this article along with other careers information, tips and advice on BioSpace
Because of previous exposure to nevirapine or other non-nucleoside reverse transcriptase inhibitors (NNRTIs), either by direct treatment or through their mothers in pregnancy, infants must often receive an alternate antiretroviral regimen that includes LPV/r. Dosing of LPV/r is currently based on a childs specific weight, and calculations of proper dosages are often too complicated to be practical in busy clinics, particularly those in limited resource settings. In order to simplify medication delivery and reduce prescribing errors, the WHO has released a dosing schedule for LPV/r based on groupings of infants and children by weight. This study will evaluate the pharmacokinetics, safety, and tolerance of LPV/r dosed according to these guidelines. The following strata were used to guide accrual:. Number of Participants to be Enrolled by Weight Band:. 3-4.9 kg: 11 liquid. 5-6.9 kg: 11 liquid. 7-9.9 kg: 17 liquid. 10-16.9 kg: 11 liquid, 22 tablet. 17-19.9 kg: 11 tablet. 20-24.9 kg: 11 ...
Sanofi Pasteur, the vaccines division of Sanofi, presented Phase II (H-030-012) trial results for an investigational vaccine for the prevention of
...- Afinitor significantly reduced tumor size by 50% or more in one out ... ...- Phase III study underway to explore potential of Afinitor to prevent... ...,Afinitor(R),Phase,II,Data,Show,Positive,Results,for,Patients,With,Multiple,Types,of,Lymphoma,,Leading,to,Phase,III,Trial,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
...RIDGEFIELD Conn. Dec. 10 2012 /- Boehringer Ingel...AML is one of the most common types of leukemia in adults. 2 ...The open-label study enrolled 87 adult patients randomly assigned to r...,Boehringer,Ingelheim,Presents,New,Phase,II,Data,for,Volasertib,in,Adult,Patients,with,AML,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters.
Subject of this analysis is the assessment of the effect of cariporideon the event probability of a myocardial infarction (MI) or death inthe scope of a coronary artery bypass graft. Thesodium-hydrogen-exchange system (NHE) in the myocardial cell inducesthe sodium and calcium influx caused by an ischaemia induced hydrogenoverload. Cariporide is a NHE-inhibitor which is seen to be delayingthe necrosis of myocardial cells caused by the ischaemia inducedcalcium influx. The influence of different intravenous doses of cariporide on thefrequency of MI and death in ACS/NQMI, PTCA, and CABG patients hadbeen investigated in a combined phase II/III trial (GUARDIAN,n=11590). Only the highest dosed CABG-subgroup showed a significantreduction of the event-rate compared to placebo of 24.7% (p=0.027).This weak dose-effect-relationship could be translated into aconcentration-effect relationship by using a populationpharmacokinetic/pharmacodynamic (PK/PD) analysis. To develop thispopulation model a series of ...
Can-Fite enrolled 326 patients through 17 scientific centers in the U.S., Europe, and Israel. The first study cohort was comprised of three hands with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All sufferers receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The principal efficacy endpoints certainly are a statistically significant improvement in regular measures utilized by dermatologists to assess psoriasis like the Psoriasis Area Sensitivity Index rating and the secondary end points among others will be the Doctors Global Assessment score as well as various safety parameters.. Can-Fite BioPharma completes affected individual enrollment in CF101 Phase II/III psoriasis trial Can-Fite BioPharma Ltd. , a biotechnology company with a pipeline of proprietary small molecule medications that address cancers and inflammatory diseases, announced today that all patients enrolled in its Phase II/III psoriasis trial for the Firms drug applicant CF101 have ...
Evotec AG (Frankfurt Stock Exchange: EVT) is pleased to invite you to a webcast presentation and conference call on detailed Phase II data for its lead compound EVT 201 in the treatment
The success of the healing process is supported by how fast the disease is detected and the extent of patient compliance in undergoing the process of therapy or treatment. The faster the cancer is detected (early stage), the higher the level of success to achieve healing. This success is also directly proportional to the level of patient adherence to follow the process of therapy. The process of cancer development is divided into four stages / phases. Phase I is the phase where the cancer is still localized to one part of the body, such as the one titi in breast, lung, and others. In phase II cancer has begun to develop in parts of the body becomes more widespread. Phase III development, even worse. Phase II and III of its development process is still in one organ of the body. Phase IV is the most dreaded phase in which the cancer has spread, or in terms of experiencing health-organ metastasis to other body organs. In this last phase of the healing process becomes very difficult. Usually ...
The success of the healing process is supported by how fast the disease is detected and the extent of patient compliance in undergoing the process of therapy or treatment. The faster the cancer is detected (early stage), the higher the level of success to achieve healing. This success is also directly proportional to the level of patient adherence to follow the process of therapy. The process of cancer development is divided into four stages / phases. Phase I is the phase where the cancer is still localized to one part of the body, such as the one titi in breast, lung, and others. In phase II cancer has begun to develop in parts of the body becomes more widespread. Phase III development, even worse. Phase II and III of its development process is still in one organ of the body. Phase IV is the most dreaded phase in which the cancer has spread, or in terms of experiencing health-organ metastasis to other body organs. In this last phase of the healing process becomes very difficult. Usually ...
Millennium Pharmaceuticals, a division of Takeda Oncology Company of Japan, released its "curtain raiser" press release Friday evening. What is a "curtain raiser" press release? These are pre-ASCO releases, distributed to the press to create excitement prior to the actual event.. Along with Celgene, Millennium is one of the two largest and most successful multiple myeloma chemotherapy drug companies. Its primary drug, Velcade, has, in some cases, doubled the median life expectancy of multiple myeloma patients.. I just wrote an article about Millennium and the trend toward crossover chemotherapy earlier today on this site. But Takeda and Millennium are making progress in other research areas, against other forms of cancer. Here is an inside look at some of the most anticipated research studies their scientists will be presenting at ASCO:. Pipeline Solid Tumor Data. TAK-700, a compound in development for the treatment of prostate cancer, will have a first presentation of Phase II data. This ...
Idera Pharmaceuticals, Inc. recently announced successful completion of the Phase I portion of the ongoing Phase I/II clinical trial of intratumoral IMO-2125. Intratumoral IMO-2125 is an agonist of TLR9, in combination with ipilimumab for the treatment of anti-PD-1 refractory metastatic melanoma. Enrollment has begun for the Phase II portion of the trial with the 8-mg dose of intratumoral IMO-2125. The Phase I dose escalation of IMO-2125 in combination with pembrolizumab is ongoing.
Read about how antibiotics developer Cempra Inc. has released positive interim results from a Phase II clinical trial for their drug, solithromycin, in the treatment of non-alcoholic steatohepatitis (NASH)
Interim Results of a Phase II Clinical Trial Comparing Outcomes of Recipients of Lungs Recovered from Uncontrolled Donation After Circulatory Determination of Death Donors (uDCDDs) Assessed by Ex-Vivo Lung Perfusion (EVLP) and CT Scan to Outcomes of Recipients of Lungs from Brain-Dead Donors (BDDs)
Researchers reported on a study of a new oral anti-clotting agent - rivaroxaban - designed to identify doses that would be safe to test in subsequent Phase III efficacy and safety trials. The results of ATLAS ACS-TIMI 46 were presented as a late-breaking clinical trial at the American Heart Associations Scientific Sessions 2008.. ...
Clovis Oncology's Rucaparib Demonstrates Encouraging Results from Ongoing Phase I/II Monotherapy Study in Patients with Solid Tumors Objective responses seen in BRCA-mutant ovarian,
NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch eTNS System for the treatment
Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating FOLFIRI and mFOLFOX6 is more effective than biweekly cetuxi
Avicena Group has announced that a Phase II clinical trial of two combination therapies incorporating ALS-08, one of its proprietary drug candidates for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrigs Disease) has been initiated.
GlobalDatas clinical trial report, Ureter Cancer Global Clinical Trials Review, H1, 2014 provides data on the Ureter Cancer clinical trial scenario. This report provides elemental information and
In the previous funding cycles of this proposal, we carried out two pivotal studies of a humanized FcR non- binding anti-CD3 mAb (hOKT3?1(Ala-Ala) or teplizumab...
Arena Pharmaceuticals watched its stock rocket more than 75% after APD334, its experimental drug for autoimmune disorders, showed strong promise in Phase II trials, slingshotting its development into Phase II. - News - PharmaTimes
Phase II studies are among the most common studies in cancer clinical research. The quality of phase II data may be one of the most important factors for predicting the success of a phase III trial (7, 8). However, many phase II trials prove to be of limited value in the drug development trajectory.. In our report, the number of phase II studies with single-agent therapy published and indexed in the PubMed database nearly doubled in the 5-year period from 2005 to 2009 as compared with 2000 to 2004 (93 studies with 5,188 patients enrolled vs. 50 studies with 2,513 patients). However, this increase did not translate into improvements in outcomes as measured by RR, PFS, and OS. The actual, rather than apparent, reality might be even more disappointing as trials with poor outcomes tend to not be published (9).. The reported outcomes (RR, PFS, and OS) did not consistently differ with respect to the type of therapy, number of institutions involved, presence of randomization, trial endpoints, number of ...
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
A total of 96 patients randomized in France and Switzerland. Results expected in Q1 2019. Lausanne, Switzerland - June 15, 2017 - Debiopharm Internati...
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.
I have a number of current research projects, under the theme of eating and drinking following head and neck cancer. 1) As part of my NIHR Clinical Lecturer award, I am conducting a feasibility study to develop a swallowing therapy intervention which draws on cognitive behavioural therapy techniques (CB-EST). This intervention aims to provide a more holistic rehabilitation approach, which addresses the physiological as well as the emotional, cognitive and behavioural changes in adjusting to living with swallowing difficulties after head and neck cancer treatment.. 2) I am a co-applicant and steering group member for a randomised controlled trial of pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer. This study is funded by NIHR HTA 3) I am a co-applicant and steering group member for PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing ...
Phase II Data Presented at ESMO and EANO 2016. MONTREAL, QC--(Marketwired - October 17, 2016) - Angiochem, a biotechnology company developing peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, recently presented data from its Phase II trial for its lead compound, ANG1005, at two highly regarded international cancer conferences: The European Society for Medical Oncology (ESMO) 2016 Congress and the European Association of Neuro-Oncology (EANO) 2016 Meeting.. On Friday Oct 7th, 2016 at the ESMO Congress, Copenhagen, Denmark, Shou-Ching Tang, MD, PhD Leader, Breast Cancer Multidisciplinary Program, Augusta University, Augusta, GA, USA presented a podium presentation titled: ANG1005, a novel peptide-paclitaxel conjugate crosses the BBB and shows activity in patients with recurrent CNS metastasis from breast cancer, results from a phase II clinical study.. In this report of the multi-center, open label Phase II trial ANG1005-CLN-04, ANG1005 demonstrated clinical benefit, ...
SHAOXING, China, Aug. 31, 2015 /PRNewswire/ -- Ascletis Initiates Phase II Clinical Trial of Its Interferon-Free HCV Regimen in Taiwan.
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.
Description: This report provides information on major design options related to the allocation of emissions allowances under the European Union Emissions Trading Scheme (the EU ETS, or the Scheme). The report was developed to assist the European Commission in the context of the review of options for the EU ETS after 2012, during the third and subsequent phases of the Scheme. The report covers topics related to allocation alternatives as well as several other issues. All of the material contained here was developed initially as a set of briefing notes for the Commission in 2007. The topics covered in the report are divided into two major categories: (1) assessment criteria and other general features, including cap-setting; and (2) allocation alternatives and issues specifically related to allocation. ...
The residential portion of the harbor will include 2,500 units, 500 of which will be located in three of the "downtown district" buildings, while the remaining 2,000 will be in the eastern portion of the project. Neighbors weary of the urbanization and subsequent transportation bustle that the project will bring to the area have called for townhouses as part of the residential development to give it more of a neighborhood feel. According to Stuart Prince, of Peterson Companies and the Residential Development Director for the project, townhouses and villas will be in a subsequent phase of the project. Final residential plans have not been announced; however, One National Harbor, a 253-unit condominium building is currently under construction with a projected completion date of December 2008. Prince said he and his team have noticed the increase in construction prices and decline in condo sales in the overall condominium market, but are not worried that National Harbor condo sales will suffer as ...
Health Canada has approved the initiation of a Phase I/II clinical trial and will enroll up to 25 patients requiring stem cell transplantation for treatment.
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.
Discover and participate in Cancer Clinical Trials through the UNC REX Cancer Care. Call 919-784-7209 to learn about available trials.
Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.
Halozyme Therapeutics has announced that as a result of a recommendation received yesterday from an independent Data Monitoring Committee (DMC), it is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced new d
CHICAGO-Safety and tolerability are consistent with prior nivolumab experience and no new safety signals have been identified in pretreated patients with a
In an ongoing phase II trial, researchers are investigating several targeted agents for use in the treatment of patients with glioblastoma (GBM).
Whilst surfing today I found this snippet in the latest Immunosyn Corporation filings to the SEC. http://www.pinksheets.com/edgar/GetFili ... ID=6254266 A Physician Sponsored IND Application to the Food and Drug Administration in the U.S. for a Phase II Clinical Trial for ...
Interim safety analysis of the secondary outcome was not initially planned and was therefore not statistically anticipated in power calculation. It was insisted upon by one of the institutions clinicians, as they suspected a significant difference between the groups. Early stopping tends to exaggerate effect, and may have led to an early false conclusion. The authors suggest that given the secondary outcome significance was p=0.01, this is unlikely (i.e. it was strongly significant difference). This is a significant weakness of the study, and some commentators have suggested it was not necessary (see links below ...
DGAP-News: Evotec SE / Key word(s): Miscellaneous10.06.2019 / 19:30 The issuer is solely responsible for the content of this announcement. THE BILL & MELINDA GATES FOUNDATION SUPPORTS EVOTEC WITH A $ 23.8 M GRANT TO GENERATE CRITICAL DATA FOR SELECTING BEST DRUG COMBINATIONS FOR PHASE II CLINICAL TRIALS TUBERCUL...
Phase II/III Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of 2 Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimers Disease
Clinical Trials and YOU What are clinical trials? Controlled studies to determine how a particular anti-cancer strategy ( i.e. treatment ) affects the people who receive it Involve rigorous scientific
Hi there! Im new here and I was wondering if there are any upcoming clinical trials. Id like to get on the list for those! Thanks, Jennifer
در این مطالعه به بررسی رسوبات کربنات کلسیم در قنات اسفزار در استان خراسان جنوبی پرداخته شد. مطالعات بر اساس کاهش سختی موقت آب در لوله‌های انتقال آب شرب در محدوده قنات انجام پذیرفت. با توجه به اینکه این قنات تنها منبع تأمین کننده آب شرب در سطح منطقه است لذا بررسی آن حائز اهمیت است. بر این اساس با افزایش pH آب توسط آهک اقدام به تشکیل رسوب در یک مخزن شد. برای تسریع در تشکیل هسته‌های رسوب از منعقدکننده‌های شیمیایی استفاده شد. بر اساس بهینه‌سازی صورت گرفته از بین منعقدکننده‌های سولفات آهن II، سولفات مس II و سولفات آهن III در pH برابر 5/9، ماده سولفات آهن III با توجه به
Phase II Data To Be Presented this Week at the 37th ICAAC in Toronto, Canada. Basel, Switzerland and Foster City, CA, USA -- September 29, 1997. F. Hoffmann-La Roche Ltd and Gilead Sciences, Inc. (NASDAQ:GILD) announced today that oral administration of the neuraminidase inhibitor GS 4104 (also known as Ro 64-0796) significantly decreased influenza viral replication and the duration of influenza symptoms when given as treatment. In addition, another Phase II study showed that GS 4104 given as prophylaxis before experimental exposure to influenza prevented illness and evidence of detectable virus. These two studies will be presented at the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto, Canada. Roche and Gilead expect to initiate the next stage of human testing, Phase II/ III studies, during the upcoming winter flu season. These treatment and prevention studies will be conducted at more than 100 clinical sites in the United States, Canada and Europe and ...
5 of 7 institutional investors in the company increased their stake last quarter. With phase II data of Resunab for cystic fibrosis on tap, hedge funds appear to be frontloading the upcoming release
MOUNTAIN VIEW, Calif., June 2, 2014 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI) reported today additional Phase II data related to CCX168, an orally administered inhibitor that targets the receptor for the complement protein known as C5a (C5aR). Data were presented in an oral presentation at the 51
Biotransformation reactions are classified into two types: phase I (nonsynthetic) and phase II (synthetic) reactions. Phase I reactions include oxidations, reductions, and hydrolysis reactions. These reactions typically introduce functional groups (ie, -OH, -SH, -NH2) that serve as active centers for subsequent phase II reactions. Enzymes catalyzing phase I reactions include cytochrome P450, aldehyde dehydrogenase, alcohol dehydrogenase, monoamine oxidase, deaminases, esterases, amidases, and epoxide hydrolase. Phase II reactions are conjugation reactions, involving an enzyme-catalyzed combination of endogenous compounds to functional groups produced from phase I reactions. These reactions utilize energy from "activated" forms of the endogenous compounds (ie, acetyl-CoA, UDP-glucuronate, glutathione). Enzymes catalyzing phase II reactions include glucuronyl transferase (conjugates glucuronyl group), sulfotransferase (conjugates sulfate group), transacylases (conjugates amino acids), glutathione ...
The initial efficacy, albeit modest, and safety results with toreforant 100 mg/day in the phase IIa study were considered supportive of further study in RA. However, a subsequent phase IIb dose-range finding study in a similar patient population did not meet its primary/secondary endpoints.. There are several possible explanations for the interstudy difference in results. Efficacy analyses from the phase IIa study were posthoc and based on limited datasets and therefore could have yielded the wrong conclusion. It also is possible that the placebo response was underestimated because of the small sample size. Alternatively, the phase IIa dose was 100 mg/day, whereas lower doses were studied in phase IIb to maximize the safety. Based on the levels needed for efficacy in preclinical mouse arthritis models, all doses studied (3, 10, 30, and 100 mg) should have been at the top of the dose-response curve and yielded comparable efficacy based on the mean Cmin values being above 6 ng/ml. However, using ...
Your privacy is as important to Cancer Council SA as it is to you. Thats why any personal information you give us will be treated with respect and in strict confidence. Personal information is collected to process donations, issue tax receipts and to send you updates. We may disclose your information to agents, contractors and third parties who provide services to us, and in doing so we take reasonable steps to ensure any information held by our service providers is protected. A full copy of our Privacy Policy is at www.cancersa.org.au/privacy with details about how you can access and correct your personal information and how we handle any privacy complaints. Or call us on 1300 65 65 85 for more details about our commitment to your privacy.. ...
A genetically engineered cold sore virus has been used to treat head and neck cancer patients in a Phase I/II clinical trial run by The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust.
B-cell lines, thereby augmenting BCR signaling. CD22 shows a B-cell specific expression from the pre-B to mature B-cell stage but is downregulated on plasma cells. Therefore, it is an attractive target for B-cell targeted immunotherapy and is already used in clinical studies to treat B-cell lymphomas and systemic autoimmune diseases. Several therapeutics based on anti-CD22 antibodies have been developed. Epratuzumab is in phase I/II clinical trials for non-Hodgkin lymphoma (NHL) treatment.
This phase I/II clinical trial of intravenous rituximab to treat Graves dysthyroid ophthalmopathy reveals a statistically significant decline in Clinical Activity Scores at 1 month, relative to baseline and sustained at 12 months, with no adverse side effects ...
Weight: The ADAM program uses censuses and propensity scoring to develop sample weights. Sample weights for each location for each year were renormalized so that the sum of all weights equaled the number of cases. This assured that the multi-year analysis would give the appropriate weight to data collected in any given year proportional to the number of cases collected. These weights were used in all statistical calculations to provide unbiased estimates for the target population of adult male arrestees at each location. Data Source: ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2000 (ICPSR 3270). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2001 (ICPSR 3688). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2002 (ICPSR 3815). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2003 (ICPSR 4020). ARRESTEE DRUG ABUSE MONITORING PROGRAM II IN THE UNITED STATES, 2007 (ICPSR 25821). ARRESTEE DRUG ABUSE MONITORING PROGRAM ...
Weight: The ADAM program uses censuses and propensity scoring to develop sample weights. Sample weights for each location for each year were renormalized so that the sum of all weights equaled the number of cases. This assured that the multi-year analysis would give the appropriate weight to data collected in any given year proportional to the number of cases collected. These weights were used in all statistical calculations to provide unbiased estimates for the target population of adult male arrestees at each location. Data Source: ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2000 (ICPSR 3270). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2001 (ICPSR 3688). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2002 (ICPSR 3815). ARRESTEE DRUG ABUSE MONITORING (ADAM) PROGRAM IN THE UNITED STATES, 2003 (ICPSR 4020). ARRESTEE DRUG ABUSE MONITORING PROGRAM II IN THE UNITED STATES, 2007 (ICPSR 25821). ARRESTEE DRUG ABUSE MONITORING PROGRAM ...
Cancer clinical trial. Clinical trial for Avelumab Treatment in Patients With Neuroendocrine Carcinomas (NEC G3) Progressive After Chemotherapy.
NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) PAR-18-665. NINDS
Measurement of quality of life QOL in cancer clinical trials has increased in recent years as more groups realize the importance of such endpoints. A key problem has been missing data. Some QOL data may unavoidably be missing, as for example when patients are too ill to complete forms. Other important sources are potentially avoidable and can...
A joint effort from the EORTC, the EANM, the ESR, and the US NCI has resulted in establishing a foundation to improve the implementation and use of imaging biomarkers in cancer clinical trials.
From BioPortfolio: MALVERN, Pa., July 17, 2015 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company developing multiple non-...
2009 Financial Outlook In 2009, Ligand expects total revenues of $30 million to $34 million and total operating expenses of $50 million to $54 million. Included in this revenue estimate is approximately $9.0 million of non-cash deferred revenue and approximately $8.5 million of non-cash expense for depreciation, amortization and stock-based compensation. Key Program Summary and Updates Schering-Plough - CXCR2: Ligands partner Schering-Plough completed a Phase II study in patients with moderate-to-severe COPD in 4Q 2008. Two Phase II studies in asthma are currently underway. In addition to CXCR2 program, the agreement has resulted in an enzyme inhibitor that entered Phase II clinical trials in November 2008 for oncology, a candidate for inflammatory diseases that entered Phase I clinical trials in March 2007, a candidate for respiratory diseases that entered Phase I clinical trials in September 2007 and a BACE inhibitor for Alzheimers disease for which a development milestone was achieved in ...
Over the several clinical experiences with CF101 for RA, Can-Fite has learned and identified the relationship between A3AR expression and response for CF101. Based on these findings, the companys last Phase IIb trial demonstrated positive data of CF101 for the treatment of RA patients based on the level of A3AR expression. The planned Phase III trial uses the same criteria for screening RA patients, and therefore has a high possibility that it will replicate the results of the last Phase IIb trial. ...
Greenwich Hospital partners with Smilow Cancer Hospital to conduct national clinical trials and research using the latest treatments and medications
Is participation in a clinical trial right for you? WebMD tells you more about brain cancer research and how you can get involved.
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". ClinicalTrials.gov. ... List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). "Vaccines for hantaviruses: Progress and ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ...
In 2007, a randomized phase II clinical trial showed that LY-2140023 taken twice daily for 4 weeks improved schizophrenia ... Current Topics in Medicinal Chemistry. 8 (16): 1480-1. doi:10.2174/156802608786264209. PMID 19006848. Fraley ME (June 2009). " ... In an early phase II monotherapy trial, the dosage shown to be efficacious was 40 mg BID. Later trials investigating the use of ... company Eli Lilly terminated further development of the compound in 2012 after it failed in phase II clinical trials. In ...
"Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24, 2013.. ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ... Priorix, MMR II, Tresivac, Trimovax, ProQuad, Priorix Tetra Mumps virus. Mumps. Mumps vaccine, MMR vaccine, MMRV vaccine ... "Current Topics in Microbiology and Immunology. Current Topics in Microbiology and Immunology. 325: 361-382. doi:10.1007/978-3- ...
As of 2009[update], the negative ion generators used are still undergoing multicenter phase II clinical trials. A separate ... Topics characterized as pseudoscience Ionized bracelet Earthing Therapy Water ionizer https://jnrbm.biomedcentral.com/articles/ ... Westrin, ÅS.; Lam, R. (2007). "Seasonal Affective Disorder: A Clinical Update". Annals of Clinical Psychiatry. 19 (4): 239-46. ... clinicaltrials.gov. Retrieved 2009-03-09. Flory R, Ametepe J, Bowers B (May 2010). "A randomized, placebo-controlled trial of ...
TIK-301 (PD-6735, LY-156,735) has been in phase II clinical trial in the United States (US) since 2002. The FDA granted TIK-301 ... Current Topics in Medicinal Chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. CS1 maint: Multiple names ... Tasimelteon completed the phase III clinical trial in the United States for primary insomnia in 2010. The Food and Drug ... It is now in phase II trials and has been since 2002. In July 2010 in Europe, prolonged-release melatonin (Circadin, Neurim ...
In a placebo controlled Phase II clinical trial with 351 subjects, eplivanserin reduced the sleep latency by 39 minutes (versus ... Teergarden, BR; Al Shamma, H; Xiong, Y (2008). "5-HT2A Inverse-Agonists for the Treatment of Insomnia". Current Topics in ...
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 - ClinicalTrials.gov". "Eli Lilly and Company » Research ... 504 (1-2): 79-96. doi:10.1016/j.ejphar.2004.09.017. PMID 15507224. Terry AV, Buccafusco JJ, Bartoszyk GD (June 2005). " ...
... "its fast-growing portfolio of Phase I, Phase II and Phase III clinical trials."[61] Termeer is on the board of directors of the ... Boston Globe staffer Geeta Anand wrote a book on the topic called The Cure.[65] ... Fierce Biotech covers biotechnology news including biopharma deals and clinical trials.[47] ... In 1998, two of Crowley's children, Megan and Patrick, were diagnosed with a severe neuromuscular disorder, Glycogen storage ...
GlaxoSmithKline for the treatment of Alzheimer's disease and demonstrated some preliminary efficacy in phase II clinical trials ... Current Topics in Medicinal Chemistry. 10 (2): 207-21. doi:10.2174/156802610790411036. PMID 20166958. Lowe, Derek (12 May 2015 ... Results of a phase III clinical trial for the treatment of Alzheimer's disease were reported in September 2017. The trial ... Intepirdine also entered clinical trials for dementia with Lewy bodies, also with negative results. Consequently, Axovant ...
... was in phase II clinical trials in 2002. In 2004, TIK-301 was designated an orphan drug by the FDA. In 2005, TIK-301 ... Current topics in medicinal chemistry. 8 (11): 954-68. doi:10.2174/156802608784936719. PMID 18673165. Mody, Sejal; Hu, Yueping ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ... 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. ...
Phase II/III trial 2009-2013". Clinicaltrials.gov. Retrieved 2012-06-20. "Wild-Type Reovirus in Combination With Sargramostim ... Chi, Judy (May 21, 2008). "Bayer launches Leukine without EDTA". Drug Topics. Leukine product website from Genzyme Leukine ... Clinical trials of sargramostim were initiated in 1987; in that same year it was administered to six people as part of a ... Schmeck HM (1987-11-02). "Radiation Team Sent to Brazil Saves Two With a New Drug". New York Times. Retrieved 2012-06-20. " ...
... provides guidance on two topics: the use of meta-analysis and the use of only a single pivotal study in phase III clinical ... EMA/CHMP/539146/2013 Investigation of subgroups in confirmatory clinical trials *^ a b FDA - Clinical trial endpoints for the ... ICH E10 - Choice of control group in clinical trials *^ CHMP/EWP/2459/02 Methodological issues in confirmatory clinical trials ... EMA/CHMP/295050/2013 Adjustment for baseline covariates in clinical trials *^ CHMP/EWP/83561/05 Clinical trials in small ...
Clinical trials have been initiated to test the effectiveness of certain worms in treating some allergies. It may be that the ... Egg allergies affect one to two percent of children but are outgrown by about two-thirds of children by the age of 5. The ... Late-phase responses seen in asthma are slightly different from those seen in other allergic responses, although they are still ... For more information on this topic, see Helminthic therapy. In the early stages of allergy, a type I hypersensitivity reaction ...
GSK suspended Phase III clinical trials in October 2008. Informations for this group of inhibitors are quite restricted. ... When they started internal screening and medicinal chemistry program, two DPP-4 inhibitors were already in clinical trials, ... Current Topics in Medicinal Chemistry, 7 (6): 547-555, doi:10.2174/156802607780091019, PMID 17352676 Wiedeman, Paul (May 2007 ... In January 2007 alogliptin was undergoing the phase III clinical trial and in October 2008 it was being reviewed by the U.S. ...
Results of clinical trials are also presented, such a sdata from a Phase II clinical trial of MT-102 in cancer-related cachexia ... a consensus of statements based on the following topics: Definitions of Cachexia, Sarcopenia and Frailty with a proposal for an ... 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 ...
... clinical trials research and decision making, as well as psychiatry and psychology. The appearance of a family illness involves ... Transition to survivorship phase of cancer journey (See: Cancer survivor) Psycho-oncology, as a subspeciality, addresses the ... A two year follow up study. Journal of Pediatric Psychology, 18, 43-56. Schultz, K. A., Ness, K. K., Whitton, J., Recklitis, C ... it is also referred to as psychosocial oncology or behavioral oncology because it deals with psychosocial and behavioral topics ...
The Junin virus genome is composed of two single-stranded RNA molecules, each encoding two different genes in an ambisense ... Over 90% of the volunteers for Phase 1 and 2 of Clinical Trials developed antibodies against the Junin virus, and 99% developed ... Enria D.A.; Barrera Oro J.G. (2002). "Junin Virus Vaccines" (PDF). Current Topics in Microbiology and Immunology. Archived from ... The two segments are termed 'short (S)' and 'long (L)' owing to their respective lengths. The short segment (around 3400 ...
... s (glutamate modulators) are a new form of antipsychotic that are in Phase II FDA study. The first ... http://www.esi-topics.com/schizophrenia/interviews/Dr-Daniel-Javitt.html http://archpsyc.ama-assn.org/cgi/content/abstract/56/1 ... a randomized Phase 2 clinical trial" (PDF). Nature Medicine. Nature Publishing Group. 13 (9): 1102-1107. doi:10.1038/nm1632. ... approximately the amount in 300 g of gelatin powder or two kilograms of sunflower seeds) remains an adjunct antipsychotic and ...
... as well as qualifications with respect to the conduct of clinical trials (phase II to IV). The working group "clinical studies ... trials on postoperative nausea and vomiting and other issues in conjunction with perioperative medicine and associated topics. ... Among these trials, many studies were aiming to get a label for the indication of PONV prevention (phase II and III trials). ... Controlled Clinical Trials 2003; 24:736-51 C. C Apfel, P. Kranke, M. H. Katz, C. Goepfert, T. Papenfuss, S. Rauch, R. Heineck, ...
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 ... is derived from their recognition in the enzyme's substrate binding pocket due to an exchange of protonation state between two ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". ClinicalTrials.gov. U.S. National ...
Started pivotal phase II clinical trials none since 2014 ? Started phase II clinical trials Mocetinostat (MGCD0103) is ... Mwakwari SC, Patil V, Guerrant W, Oyelere AK (2010). "Macrocyclic histone deacetylase inhibitors". Current Topics in Medicinal ... Started phase III clinical trials Panobinostat (LBH589) is in clinical trials for various cancers including a phase III trial ... Clinical trial number NCT00532818 for "Hydralazine Valproate for Cervical Cancer" at ClinicalTrials.gov Clinical trial number ...
Successful pre-clinical, Phase I, and Phase II trials looked promising to the company and its investors even up until the third ... though it is a topic of debate.[8][14] ... No severe side effects were reported in any clinical trial, and ... quarter of 2002.[11] Phase I studies show little to no side effects of deramciclane.[8][12][13][14] Phase II studies show ... was discontinued during Phase III trials due to clinically insignificant results compared to placebo groups.[11] ...
In phase II clinical trials, expected to enroll patients in phase III studies in 2018. FLU-IGIV (Seasonal Influenza Therapeutic ... 2001 Anthrax toxin Anthrax Vaccine Immunization Program Biotechnology List of pharmaceutical companies List of vaccine topics ... In phase II clinical trials UV-4B (Dengue Therapeutic) ZIKV-IG (Zika Therapeutic) GC-072 (Burkholderia Therapeutic) FILOV (Pan- ... The vaccine could reach stage-one clinical trials by early 2017. As of the end of June 2016, 60 countries and territories had ...
As of 2008, 16 topical microbicides entered phase I or II clinical trial and 7 advanced to an additional trial. Previous ... and public policy writers have at times faced opposition to promoting discussion on anal topics. Scientists at the Population ... Phase I trials normally focus solely on safety and acceptability, but researchers used a novel approach in this trial: taking ... the first Phase II expanded safety and acceptability study of an RM. The trial was officially launched in October 2013 at sites ...
Zinc ejectors were patented in 2008 and some have entered Phase I/II trials as a HIV drug. The HIV-1 nucleocapsid protein 7 ( ... Azodicarbonamide (ADA) was the first zinc ejector to go into clinical trial for treatment of HIV. ADA inhibits HIV by ... Current Topics in Medicinal Chemistry. 4 (15): 1605-1622. doi:10.2174/1568026043387331. PMID 15579099. Topol, Igor A.; Nemukhin ... NCp7 is a 55-amino acid protein that is highly basic and consists of two gag-knuckle motifs. These motifs contain two peptide ...
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... "Physiologists divide nerve-fibers, which form the nerves, into two classes, afferent and efferent. Impressions are made on the ... BEIR VII Phase 2. Washington, DC: The National Academies Press. ISBN 0-309-09156-X.. CS1 maint: Multiple names: authors list ( ... List of topics characterized as pseudoscience. *Chiropractic education. *Chiropractic schools. *Councils on Chiropractic ...
Clinical Trials, Phase II as Topic*Clinical Trials, Phase II as Topic ... "Clinical Trials, Phase II as Topic" by people in this website by year, and whether "Clinical Trials, Phase II as Topic" was a ... Drug Evaluation, FDA Phase II as Topic*Drug Evaluation, FDA Phase II as Topic ... Evaluation Studies, FDA Phase II as Topic*Evaluation Studies, FDA Phase II as Topic ...
nyse mkt:SYN), a clinical-stage company focused on developing therapeutics to... ... two Phase 2a studies ongoing] and an oral statin treatment to reduce the impact of methane producing organisms on irritable ... clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a ... clinical trials to receive anticipated funding, a failure of Synthetic Biologics products for the prevention and treatment of ...
NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of... ... Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... results and timing of clinical trials, the timing of the release of clinical trial results, and plans regarding future research ... in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials ...
Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... "We look forward to discussing these Phase II results with the FDA and progressing into pivotal Phase III clinical trials." ... Phase II clinical trial for Dex-IN, a proprietary intranasal formulation of dexmedetomidine, for the treatment of acute pain in ... Recro Pharma Announces Positive Top-Line Results for Phase II Clinical Trial of Dex-IN. 20:00 EDT 16 Jul 2015 , Globe Newswire ...
Topics * All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the ... Topics. All Topics Biotechnology Biotech Business Biotech Products Cancer Cardiovascular Dermatology Drug Discovery ... Aeglea BioTherapeutics Announces Positive Interim Clinical Data and Completion of Enrollment for Ongoing Phase 1/2 Trial of ...
A phase I‐II clinical trial of the anti‐CD74 monoclonal antibody milatuzumab in frail patients with refractory chronic ...
More news releases in similar topics. * All Summer Health & Safety News Releases ... INCEPTUS Pre-Phase 1, Prospective, Non-Interventional, Natural History Run-in Study to Evaluate Subjects Aged 3 Years and ... ASPIRO Phase 1/2 Gene Therapy Trial In X-Linked Myotubular Myopathy (XLMTM): Preliminary Safety and Efficacy Findings. Abstract ... the timing and results of preclinical and clinical trials, the companys ability to fund development activities and achieve ...
Phase II studies are done to study the effectiveness and safety of the experimental study drug or treatment in a controlled ... Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the ... Clinical Trials - Different Phases of the trial - Related News. * Urgent Requirement of Large Clinical Trials to Evaluate Risks ... Clinical Trials - Phase II. In this phase the effectiveness and safety of the experimental study drug or treatment is evaluated ...
MedlinePlus related topics: Smallpox Genetic and Rare Diseases Information Center resources: Smallpox ... Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®. This study has been completed. ... This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study ... A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of IMVAMUNE® Using Three Immunization ...
Interventional (Clinical Trial) Actual Enrollment :. 43 participants. Allocation:. Randomized. Intervention Model:. Parallel ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... A Phase 2 Study Of PF-00232798 In HIV Positive Patients. The safety and scientific validity of this study is the responsibility ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495677 ...
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer. The safety and scientific validity of this study is the ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... ClinicalTrials.gov Identifier: NCT01807156. Recruitment Status : Terminated (Primary endpoint not met) First Posted : March 8, ... ClinicalTrials.gov Identifier:. NCT01807156 History of Changes Other Study ID Numbers:. IRB00061422 IRB00061422 ( Other ...
Trial record 1 of 1 for: NCT02193334 Previous Study , Return to List , Next Study ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase I/II Study of KP-100IT in Acute Spinal Cord Injury. The safety and scientific validity of this study is the ... A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord ...
MedlinePlus related topics: Leukemia Drug Information available for: Ruxolitinib Ruxolitinib phosphate Genetic and Rare ... Interventional (Clinical Trial) Actual Enrollment :. 30 participants. Intervention Model:. Single Group Assignment. ... Phase l/II Study of Ruxolitinib for Acute Leukemia. The safety and scientific validity of this study is the responsibility of ... A Phase I/II Study to Determine the Safety and Efficacy of Ruxolitinib, a JAK1/JAK2 Inhibitor, in Subjects With Relapsed or ...
Trial record 1 of 1 for: NCT02383927 Previous Study , Return to List , Next Study ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations. The safety and scientific validity of this ... Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in subjects with advanced tumors that carry ...
Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. [ Time Frame: 48 weeks ]. Study subjects were given ... Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; ... An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis. The safety and scientific validity ... Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men ...
Interventional (Clinical Trial) Actual Enrollment :. 70 participants. Allocation:. Non-Randomized. Intervention Model:. Single ... MedlinePlus related topics: Stomach Cancer Genetic and Rare Diseases Information Center resources: Stomach Cancer ... Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection. The safety and ... Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab ...
MedlinePlus related topics: Leukemia Drug Information available for: Bortezomib Genetic and Rare Diseases Information Center ... Interventional (Clinical Trial) Actual Enrollment :. 0 participants. Allocation:. Non-Randomized. Intervention Model:. Single ... Phase II Study of VELCADE for Relapsed or Refractory T-cell Prolymphocytic Leukemia. The safety and scientific validity of this ... Phase II Study of Bortezomib (VELCADE) for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia. ...
ClinicalTrials.gov Identifier:. NCT00322049 History of Changes Other Study ID Numbers:. WRAIR 824 HSRRB Log A-10064 ( Other ... MedlinePlus related topics: Dengue Genetic and Rare Diseases Information Center resources: Dengue Fever Hemorrhagic Fever Viral ... A Phase I/II Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants. This study has been ... This is a Phase I/II, randomized, observer-blind, controlled trial. Thirty-four flavivirus naïve infants will be randomized to ...
ClinicalTrials.gov Identifier: NCT01801358. Recruitment Status : Terminated (The trial was terminated for scientific reasons.) ... MedlinePlus related topics: Melanoma Genetic and Rare Diseases Information Center resources: Intraocular Melanoma Ocular ... The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical ... A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma. The safety and scientific validity ...
The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib). ... MedlinePlus related topics: Pancreatic Cancer Genetic and Rare Diseases Information Center resources: Pancreatic Cancer ... A Phase I Clinical Trial. Clin Cancer Res. 2015 May 15;21(10):2305-14. doi: 10.1158/1078-0432.CCR-14-2280. Epub 2015 Feb 16. ... BATs Treatment for Pancreatic Cancer, Phase Ib/II. The safety and scientific validity of this study is the responsibility of ...
ClinicalTrials.gov Identifier:. NCT00490529 History of Changes Other Study ID Numbers:. LYMNHL0040-BMT212 LYMNHL0040-BMT212 ( ... MedlinePlus related topics: Lymphoma Genetic and Rare Diseases Information Center resources: Lymphosarcoma Mantle Cell Lymphoma ... The primary endpoint of the trial is freedom from molecular residual disease (MRD) at the landmark of one-year post-transplant ... Phase Lymphoma, Mantle-Cell Biological: CpG-MCL vaccine, primed T-cells Procedure: Autologous peripheral blood stem cell ...
Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. Quality of Life (QOL), are ... MedlinePlus related topics: Carcinoid Tumors Drug Information available for: Malic acid Sunitinib malate Sunitinib ... This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until ... Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization. This study has been completed. ...
Interventional (Clinical Trial) Actual Enrollment :. 55 participants. Allocation:. Non-Randomized. Intervention Model:. ... MedlinePlus related topics: Mesothelioma Drug Information available for: Durvalumab Genetic and Rare Diseases Information ... Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma (PrE0505). The safety ... Open Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With ...
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522795 ... MedlinePlus related topics: Esophageal Cancer Drug Information available for: Cisplatin Paclitaxel Genetic and Rare Diseases ... Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001). The safety and ... BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial ...
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate ... MedlinePlus related topics: Soft Tissue Sarcoma Drug Information available for: Malic acid Sunitinib malate Sunitinib ... This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate ... Concurrent treatment on another clinical trial, except supportive care or non-treatment trials ...
  • Kura Oncology's lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. (bioportfolio.com)
  • Phase -II studies also help determine, risks associated with the drug as well as short term side effects. (medindia.net)
  • Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug. (clinicaltrials.gov)
  • LY-404,039, also known as pomaglumetad, is an amino acid analog drug that acts as a highly selective agonist for the metabotropic glutamate receptor group II subtypes mGluR2 and mGluR3. (wikipedia.org)
  • In July 2007, the open Investigational New Drug (IND) was transferred to Tikvah Therapeutics Inc. in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. (wikipedia.org)
  • FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. (wikipedia.org)
  • This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. (wikipedia.org)
  • FDA: Clinical trial endpoints for the approval of cancer drugs and biologics provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. (wikipedia.org)
  • The randomization is discussed in: FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications, chapter 6. (wikipedia.org)
  • Rectal application of UC-781 gel, a potent antiretroviral (ARV) drug, was shown to be safe and acceptable to the 36 men and women in the trial. (wikipedia.org)
  • The United States Food and Drug Administration states that it is not clear if CCSVI exists as a clinical entity and that these treatments may cause more harm. (wikipedia.org)
  • By supporting research projects around the world, it seeks to increase the chances of finding treatments for Alzheimer's disease, related dementias and cognitive aging ADDF has invested nearly $65 million to fund some 450 Alzheimer's drug discovery programs and clinical trials in academic centers and biotechnology companies in 18 countries. (wikipedia.org)
  • After initial ADDF funding, grantees have received commitments of over $2 billion in follow-on funding from government, pharmaceutical companies and venture capital firms to further advance drug research. (wikipedia.org)
  • Through its programs, the ADDF has invested close to $65 million to fund nearly 450 Alzheimer's drug discovery programs and clinical trials in academic centers and biotechnology companies in 18 countries. (wikipedia.org)
  • Similarly, the phase III efficacy trial of Carraguard showed that the drug was safe for use but ineffective in preventing HIV transmission in women. (wikipedia.org)
  • It has passed the animal-testing phases of the drug-approval process in Australia and the United States, which will be followed by initial human safety tests. (wikipedia.org)
  • Zinc ejectors were patented in 2008 and some have entered Phase I/II trials as a HIV drug. (wikipedia.org)
  • After a decade of work in drug discovery Caro was recruited again by the Brody School of Medicine at ECU, where he became the Associate Dean for Clinical Investigation and the founding Director of the ECU Metabolic Institute. (wikipedia.org)
  • Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. (wikipedia.org)
  • The aim of an adaptive trial is to more quickly identify drugs or devices that have a therapeutic effect, and to zero in on patient populations for whom the drug is appropriate. (wikipedia.org)
  • In 2012, the President's Council of Advisors on Science and Technology (PCAST) recommended that FDA "run pilot projects to explore adaptive approval mechanisms to generate evidence across the lifecycle of a drug from the premarket through the postmarket phase. (wikipedia.org)
  • citation needed] Studies have placed the amount spent on drug marketing at 2-19 times that on drug research. (wikipedia.org)
  • citation needed] Pharmaceutical companies spend a large amount on research and development before a drug is released to the market and costs can be further divided into three major fields: the discovery into the drug's specific medical field, clinical trials, and failed drugs. (wikipedia.org)
  • After the investigation into the drug and given approval, pharmaceutical companies can move into pre-clinical trials and clinical trials. (wikipedia.org)
  • Drug development and pre-clinical trials focus on non-human subjects and work on animals such as rats. (wikipedia.org)
  • citation needed] The Food and Drug Administration mandates a 3 phase clinical trial testing that tests for side effects and the effectiveness of the drug with a single phase clinical trial costing upwards of $100 million. (wikipedia.org)
  • After a drug has passed through all three phases, the pharmaceutical company can move forward with a New Drug Application from the FDA. (wikipedia.org)
  • The first experimental antivirals were developed in the 1960s, mostly to deal with herpes viruses, and were found using traditional trial-and-error drug discovery methods. (wikipedia.org)
  • Vanoxerine is a drug that was in the midst of recruiting participants for a phase III human clinical trial for its use as a cardiac antiarrhythmic when safety concerns arose. (wikipedia.org)
  • Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials. (wikipedia.org)
  • The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. (wikipedia.org)
  • The drug discovery process generally follows the following path that includes a hit to lead stage: target validation (TV) → assay development → high-throughput screening → hit to lead (H2L) → lead optimization (LO) → preclinical drug development → clinical drug development The hit to lead stage starts with confirmation and evaluation of the initial screening hits and is followed by synthesis of analogs (hit expansion). (wikipedia.org)
  • On average, only one in every 5,000 compounds that enters drug discovery to the stage of pre-clinical development becomes an approved drug. (wikipedia.org)
  • The objective of this drug discovery phase is to synthesize lead compounds, new analogs with improved potency, reduced off-target activities, and physiochemical/metabolic properties suggestive of reasonable in vivo pharmacokinetics. (wikipedia.org)
  • The design of a clinical trial will depend on the drug and the phase of its development. (wikipedia.org)
  • Effectiveness is the extent to which a drug works under real world circumstances, i.e., clinical practice. (wikipedia.org)
  • Efficacy is the extent to which a drug works under ideal circumstances, i.e., in clinical trials. (wikipedia.org)
  • The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1c levels. (bioportfolio.com)
  • Such forward-looking statements include statements regarding, among other things, the potential utility of tipifarnib and the Company's other product candidates, the conduct, results and timing of clinical trials, the timing of the release of clinical trial results, and plans regarding future research and development activities. (bioportfolio.com)
  • The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials. (indiatimes.com)
  • Kranke is known for the design and conduct of clinical studies and for performing systematic reviews in the context of perioperative medicine. (wikipedia.org)
  • Kranke also holds special titles for intensive care medicine, pain management palliative care, emergency medicine, acupuncture and medical quality management (Bavarian chamber of physicians) as well as qualifications with respect to the conduct of clinical trials (phase II to IV). (wikipedia.org)
  • The focus on evidence-base medicine in anaesthesia soon led to the conduct of Cochrane Reviews and their regular update in the field of perioperative medicine and associated topics, a topic that still constitutes a main focus of the group. (wikipedia.org)
  • TCRF receives income from pharmaceutical sponsors to conduct clinical trials, and organizes annual fundraisers. (wikipedia.org)
  • Cohort 2: Squamous Head and Neck Cancer with HRAS mutations. (clinicaltrials.gov)
  • histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) or squamous head and neck cancer (cohort 2) for which there is no curative therapy available. (clinicaltrials.gov)
  • In Stage II, an expanded cohort will receive the dose defined in Stage I (MTD or highest dose if MTD is not reached), instilled 6 times daily into each eye for 12 weeks (84 days). (clinicaltrials.gov)
  • In 1996, he was recruited away from UCSF by Chiron, one of the early Bay Area biotechnology companies, where he served as Corporate VP responsible for the clinical development of both therapeutics and vaccines until its acquisition in 2006 by Novartis, where he remained for two years. (wikipedia.org)
  • Prospective students must also take the UK Clinical Aptitude Test (UKCAT) in the year preceding their application. (wikipedia.org)
  • Vitrification has also become the method of choice for pronuclear oocytes, although prospective randomized controlled trials are still lacking. (wikipedia.org)
  • Some experimental treatments, including systemic hypothermia, have been performed in isolated cases in order to draw attention to the need for further preclinical and clinical studies to help clarify the role of hypothermia in acute spinal cord injury. (wikipedia.org)
  • This second phase of testing may last from several months to two years. (medindia.net)
  • Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). (clinicaltrials.gov)
  • Those conferences have taken place every two years. (wikipedia.org)
  • the longest period between presumed exposure and clinical presentation is 62 years. (wikipedia.org)
  • Five years to the term breech trial: the rise and fall of a randomized controlled trial. (wikipedia.org)
  • These two groups largely diverged over the years. (wikipedia.org)
  • The emerging pattern of sub-teams are currently: Multidisciplinary clinical teams providing an intensive case management approach for the first three to five years. (wikipedia.org)
  • Forced to submit to psychological examinations and undergo retraining, Gonzalez was given two years of probation with a stipulation that he undergo retraining and do 200 hours of community service, which he completed satisfactorily. (wikipedia.org)
  • The FRIENDS protocol has been adapted into four developmentally-sensitive programs: Fun FRIENDS (4 - 7 years) FRIENDS for life (8 - 11 years) My FRIENDS Youth (12 - 15 years) Adult Resilience for Life (16 years and over) The programs are typically delivered over 10 session with two booster sessions, typically 60-75 minutes. (wikipedia.org)
  • This concept includes phase II studies conducted in both the U.S. and in other countries. (umassmed.edu)
  • can any one give me different names given to different phases in clinical studies? (medindia.net)
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as 5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase II studies. (clinicaltrials.gov)
  • This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. (wikipedia.org)
  • The working group "clinical studies" and trial management, headed by Kranke, compiles systematic reviews on interventions in health care with associated economic benefit assessment according to the criteria of the cochrane collaboration, other systematic reviews and has a coordinating role with respect to clinical trials. (wikipedia.org)
  • Among these trials, many studies were aiming to get a label for the indication of PONV prevention (phase II and III trials). (wikipedia.org)
  • Berger was heavily involved as principal investigator of these agents and co-authored several resultant iconic publications of trials including the Power 2, Titan, Duet and Startmrk studies and the first studies of elvitegravir. (wikipedia.org)
  • In 1986, he began his studies of Medicine at the University of Ulm, and received his Ph.D. from the institution's Department of Clinical Genetics in 1994. (wikipedia.org)
  • Many advocates in the PAIR program also participate in clinical studies themselves. (wikipedia.org)
  • Additionally, the thalidomide tragedy led the FDA to issue regulations in 1977 recommending that women should be excluded from participating in Phase I and Phase II studies in the US. (wikipedia.org)
  • Studies on discordant partners (one infected with HSV-2, one not) show that the transmission rate is approximately 5 per 10,000 sexual contacts. (wikipedia.org)
  • The next waves of studies on the topic came with the discovery of immunosuppressive drugs. (wikipedia.org)
  • On June 21, 2016, Emergent announced that it had moved a step forward in the process: the FDA completed the pre-approval phase of its inspection. (wikipedia.org)
  • Kathy Berger (1926-2016) was a survivor of Nazi Concentration camp Auschwitz, liberated from Bergen-Belsen at the end of WW II. (wikipedia.org)
  • Glezerman has published five books on the topics of obstetrics and gynecology and will publish his sixth book in the summer of 2016. (wikipedia.org)
  • and three in phase 3, one of which (Trulicity) became a product in 2016. (wikipedia.org)
  • Lisdexamfetamine is a Class B/Schedule II substance in the United Kingdom and a Schedule II controlled substance in the United States (DEA number 1205) and the aggregate production quota for 2016 in the United States is 29,750 kilograms of anhydrous acid or base. (wikipedia.org)
  • Early human trials using this prodrug form of LY-404,039 gave encouraging results. (wikipedia.org)
  • Very early, and based on results of conducted systematic reviews, Kranke and colleagues highlighted the suspicious trial results published by Fujii and colleagues. (wikipedia.org)
  • In its lifetime, NCp7 facilitates the unwinding of tRNA, acts as a primer for reverse transcription, chaperones nucleic acids within the capsid of HIV-1, helps integrate the viral RNA into budding virions, and is intimately involved in the replication of HIV-1 in both the early phase and late phase. (wikipedia.org)
  • He thought about this well established organisation when working in the early phases of SRBR, hoping to create a society with the ability to make a lasting impact. (wikipedia.org)
  • One specific type of sequential design is the "two-armed bandit", generalized to the multi-armed bandit, on which early work was done by Herbert Robbins in 1952. (wikipedia.org)
  • Two types of cannabinoid receptors, CB1 and CB2, responsible for the effects of THC were discovered and cloned in the early 1990s. (wikipedia.org)
  • These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the Journal of Translational Medicine ," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. (bioportfolio.com)