Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about 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.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
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.
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.
Substances that inhibit or prevent the proliferation of NEOPLASMS.
A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.
Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
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.
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.
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.
Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.
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.
Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.
A 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.
Elements of limited time intervals, contributing to particular results or situations.
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
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.
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.
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.
The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used.
The relationship between the dose of an administered drug and the response of the organism to the drug.
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.
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.
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.
The giving of drugs, chemicals, or other substances by mouth.
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
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.
Tumors or cancer of the LUNG.
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.
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
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.
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.
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.
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)
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.
Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity.
The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.
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.
Organic compounds which contain platinum as an integral part of the molecule.
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.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
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)
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)
Tumors or cancer of the human BREAST.
A decrease in the number of NEUTROPHILS found in the blood.
Therapy with two or more separate preparations given for a combined effect.
Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
An organoplatinum compound that possesses antineoplastic activity.
Antibodies produced by a single clone of cells.
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.
A publication issued at stated, more or less regular, intervals.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
Earlier than planned termination of clinical trials.
Antimetabolites that are useful in cancer chemotherapy.
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)
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.
Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.
Antitumor alkaloid isolated from Vinca rosea. (Merck, 11th ed.)
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.
A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.
The return of a sign, symptom, or disease after a remission.
An antineoplastic agent. It has significant activity against melanomas. (from Martindale, The Extra Pharmacopoeia, 31st ed, p564)
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
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.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
Therapeutic act or process that initiates a response to a complete or partial remission level.
The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.
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.
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.
A 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.
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.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).
A 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)
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)
A subspecialty of internal medicine concerned with the study of neoplasms.
Organic salts and esters of benzenesulfonic acid.
The teaching or training of patients concerning their own health needs.
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.
Resistance or diminished response of a neoplasm to an antineoplastic agent in humans, animals, or cell or tissue cultures.
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
A 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.
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.
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.
A subnormal level of BLOOD PLATELETS.
Compounds that include the amino-N-phenylamide structure.
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.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
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.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
An 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.
Activities performed to identify concepts and aspects of published information and research reports.
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).
Voluntary cooperation of the patient in following a prescribed regimen.
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.
Agents and endogenous substances that antagonize or inhibit the development of new blood vessels.
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.
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.
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)
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Congener of FLUOROURACIL with comparable antineoplastic action. It has been suggested especially for the treatment of breast neoplasms.
The forcible expulsion of the contents of the STOMACH through the MOUTH.
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
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.
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.
Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.
Financial support of research activities.
Tumors or cancer of the PROSTATE.
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.
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.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
Agents that inhibit PROTEIN KINASES.
Disorders of the blood and blood forming tissues.
Antagonist of urate oxidase.
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.
Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.
That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Compounds with a six membered aromatic ring containing NITROGEN. The saturated version is PIPERIDINES.
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)
Azoles of one NITROGEN and two double bonds that have aromatic chemical properties.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Patient involvement in the decision-making process in matters pertaining to health.
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)
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.
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.
Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.
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.
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.
An antitumor alkaloid isolated from VINCA ROSEA. (Merck, 11th ed.)
Method of measuring performance against established standards of best practice.
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.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
Tumors or cancers of the KIDNEY.
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)
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.
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.
Use of plants or herbs to treat diseases or to alleviate pain.
"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.
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.
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.
Tumors or cancer of the STOMACH.
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
Injections made into a vein for therapeutic or experimental purposes.
Tumors or cancer of the PERITONEUM.
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.
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.
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.
Proteins prepared by recombinant DNA technology.
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.
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.
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.
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.
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)
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)
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.
Disease having a short and relatively severe course.
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.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
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.
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.
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.
Tumors or cancer of the LIVER.
Antibodies obtained from a single clone of cells grown in mice or rats.
Cyclic hydrocarbons that contain multiple rings and share one or more atoms.
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.
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).
The study of chance processes or the relative frequency characterizing a chance process.
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.
Forceful administration under the skin of liquid medication, nutrient, or other fluid through a hollow needle piercing the skin.
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms.
Organic compounds that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine.
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.
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)
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 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.
Inorganic or organic compounds that contain the basic structure RB(OH)2.
A connective tissue neoplasm formed by proliferation of mesodermal cells; it is usually highly malignant.
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.
A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)
A 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.
A class of statistical methods applicable to a large set of probability distributions used to test for correlation, location, independence, etc. In most nonparametric statistical tests, the original scores or observations are replaced by another variable containing less information. An important class of nonparametric tests employs the ordinal properties of the data. Another class of tests uses information about whether an observation is above or below some fixed value such as the median, and a third class is based on the frequency of the occurrence of runs in the data. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1284; Corsini, Concise Encyclopedia of Psychology, 1987, p764-5)

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
New Novartis Phase II data show LCZ696 may provide clinical benefits in patients with a difficult-to-treat form of heart failure -- PARAMOUNT study shows LCZ696 reduced a key predictor of...
New phase II data presented at ECCO 15 - 34th ESMO Congress reinforces exciting potential of Algetas Alpharadin as a new treatment for bone metastases in cancer patients Oslo, Norway, 22 September
Allergan Reports Topline Phase II Data Supporting Advancement of BOTOX® (onabotulinumtoxinA) for the Treatment of Major Depressive Disorder (MDD)
Sanofi reports that the first patient outside of the US has been treated as part of a global clinical program evaluating Sanofis and Regeneron Pharmaceuticals Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the US, all countries that have been impacted by COVID-19. Sanofi is leading trials outside the US while Regeneron is leading US trials.. This is the second multi-center, double-blind, Phase II/III trial as part of the Kevzara COVID-19 program, and the companies say that they are continuing to work with authorities around the world to secure initiation at additional sites. This follows Sanofi and Regenerons earlier announcement of the initiation of the first trial, which is US-based.. Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive ...
Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks ...
This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung
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.
AzurRx BioPharma is a development stage biopharmaceutical company (NASDAQ: AZRX) focused on the development of recombinant proteins for the treatment of gastrointestinal diseases and microbiome related conditions. Our therapeutic products will be administered to patients as oral non-systemic biologics.
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 ...
Roches breakthrough immunotherapy atezolizumab is being given a priority review in the US on the back of Phase II data supporting its potential as a treatment for bladder cancer. - News - PharmaTimes
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.
This course is mainly focused on the quantitative aspects of design and presents a unifying framework called Multidisciplinary System Design Optimization (MSDO). The objective of the course is to present tools and methodologies for performing system optimization in a multidisciplinary design context, focusing on three aspects of the problem: (i) The multidisciplinary character of engineering systems, (ii) design of these complex systems, and (iii) tools for optimization. There is a version of ...
Kiadis announces that ongoing Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) data for ATIR101™ has been selected for presentation
Axon Presented Positive Phase II Trial Results of AADvac1 at AAT-AD/PD 2020 - read this article along with other careers information, tips and advice on BioSpace
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 ...
The pharmacokinetics (PK) of ADS-5102 were assessed in two phase I studies in healthy subjects, and a blinded, randomized phase II/III dose-finding study in PD ...
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 ...
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
GTB-3550 is the Companys first TriKE™ product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.. About GTB-3550 TriKE™ Clinical Trial ...
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We conclude that this drug combination and dosage are feasible and have potential as either a front- or second-line chemotherapeutic regimen for advanced lung cancer, and phase II/III trials should be performed. However, hematologic toxicities, as found in this study, could probably be reduced with …
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 ...
Buy Flex GF Chair w/ Gas Lift II from A2S. The Flex has an ergonomically shaped plastic shell, which promotes sitting to prevent fatigue and supports mu...
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
In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ... However, their prospects are unclear List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). " ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ...
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 ... worsening of extrapyramidal symptoms were reported in association with LY-2140023 use during an initial phase II clinical trial ...
July 2017). "Low-dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial". Annals of Clinical ... Zhang YL, Keng YF, Zhao Y, Wu L, Zhang ZY (May 1998). " ... Suramin has been studied in a mouse model of autism and in a small phase I/II human trial. "Suramin Injection Advanced Patient ... Suramin was studied as a possible treatment for prostate cancer in a clinical trial. ...
Generally, the PAT initiative from FDA is only one topic within the broader initiative of "Pharmaceutical cGMPs for the 21st ... at the time of conducting phase-2 clinical trials. ...
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 ... It is now in phase II trials and has been since 2002. In July 2010 in Europe, prolonged-release melatonin (Circadin, Neurim ... Additionally, Neurim Pharmaceuticals reported the results of a positive phase II trial of its investigational compound ...
In a placebo controlled Phase II clinical trial with 351 subjects, eplivanserin reduced the sleep latency by 39 minutes (versus ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ...
It is the first telomerase inhibitor to enter clinical trials. It is currently in Phase 2/3 trials for various cancer types. ... 2020). "Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials". Current Topics in Medicinal Chemistry. 20 (6 ...
It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ... "Efficacy Study of LY2422347 to Treat Insomnia - Full Text View -". "Eli Lilly and Company » Research ... 504 (1-2): 79-96. doi:10.1016/j.ejphar.2004.09.017. PMID 15507224. Terry AV, Buccafusco JJ, Bartoszyk GD (June 2005). " ...
Pullen, L.C. (November 7, 2011). "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24 ... "Inferring Reasons for the Failure of Staphylococcus aureus Vaccines in Clinical Trials". Frontiers in Cellular and Infection ... Innovations Council of State and Territorial Epidemiologists Edward Jenner Institute for Vaccine Research Every Child By Two ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ...
... 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 S, Hu Y, Ho MK, Wong ... in Atlanta, GA by Phase II Discovery, where it was renamed to TIK-301. Currently, clinical trials are ongoing there. Because it ... 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. ...
Over four decades his team has investigated a range of topics including: bacterial electron transport systems; the genomics and ... one of the two Swiss Federal Institutes of Technology). His laboratory at EPFL closed in December 2018. He was previously ... MCZ is currently in phase 2 clinical trials. Stewart Cole was appointed as the 16th director general of the Pasteur Institute ... He took office on 2 January 2018, when he began to prepare the institute's Strategic Plan for 2019-2023. The overarching ...
... "its fast-growing portfolio of Phase I, Phase II and Phase III clinical trials." Termeer is on the board of directors of the MGH ... Boston Globe staffer Geeta Anand wrote a book on the topic called The Cure. Crowley was profiled in The Wall Street Journal by ... Fierce Biotech covers biotechnology news including biopharma deals and clinical trials. When Prosensa was founded in 2002 in ... In 1998, two of Crowley's children, Megan and Patrick, were diagnosed with a severe neuromuscular disorder, Glycogen storage ...
"A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)ide Reverse Transcriptase ... Ranging Clinical Trial". The Journal of Infectious Diseases. 201 (6): 814-22. doi:10.1086/650698. PMID 20146631. Falutz, Julian ... Berger often lectures to physicians around the US on topics relating to incorporating of newer antiretroviral therapies into ... A randomised controlled phase III trial". The Lancet. 370 (9581): 49-58. doi:10.1016/S0140-6736(07)61049-6. PMID 17617272. http ...
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 ...
... a second round of clinical trials in Korea has begun with 10 hospitals participating. Multiple Phase 2/3 and Phase 3 clinical ... "Current Practices in Acute Blood Purification Therapy in Japan and Topics for Further Study". Contributions to Nephrology. 196 ... "Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial - Full Text View". 2020-07-23. Retrieved 2021- ... This drug has been identified as a potential therapy for COVID-19, with clinical trials in Japan possibly set to begin in March ...
Altinicline has undergone Phase II clinical trials. The Sonogashira cross coupling reaction can be used in the synthesis of ... Chem., Topics in Organometallic Chemistry, 6: 205-245, doi:10.1007/b94551, ISBN 978-3-540-01603-8 Cassar, L. (1975), "Synthesis ... Typically, two catalysts are needed for this reaction: a zerovalent palladium complex and a copper(I) halide salt. Common ... Gold(I) chloride has been used as co-catalyst combined with palladium(II) chloride in the coupling of arenediazonium salts with ...
... provides guidance on two topics: the use of meta-analysis and the use of only a single pivotal study in phase III clinical ... CPMP/EWP/2158/99: Choice of a non-inferiority (EMA) provides guidance on two types of non-inferiority trials: trials with two ... ICH E9: Statistical principles for clinical trials section III provides a general overview of common designs in clinical trials ... EMA/286914/2012: Multiplicity issues in clinical trials (EMA) addresses the multiplicity in the clinical trials in the context ...
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 ...
The Servier Clinical Support Unit in Gidy (near Orléans), which produces drugs for clinical trials, is the largest unit of its ... "IMI Call Topics 2008". IMI-GB-018v2-24042008-CallTopics.pdf. European Commission. Archived from the original on 2009-10-15. ... "Servier and Galapagos complete enrollment of global ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in knee ... One example, in the area of non-clinical safety assessment, is the InnoMed PredTox. The company is expanding its activities in ...
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): 579-595, doi:10.2174/156802607780091000, PMID 17352679 Cox, Jason; Harper, Bart; ... In January 2007 alogliptin was undergoing the phase III clinical trial and in October 2008 it was being reviewed by the U.S. ...
... ligand alpha-galactosylceramide is currently in phase I clinical trials for the treatment of advanced non-hematologic cancers. ... Current Topics in Microbiology and Immunology. 314: 27-50. doi:10.1007/978-3-540-69511-0_2. ISBN 978-3-540-69510-3. PMID ... CD1 glycoproteins can be classified primarily into two groups which differ in their lipid anchoring. CD1a, CD1b and CD1c (group ... Group 2 CD1 molecules activate a group of T cells, known as Natural killer T cells because of their expression of NK surface ...
... entered clinical trials and a phase 1 report in 2020 suggested safety and tolerability. In 2018, an antibody, PRX002/RG7935, ... showed preliminary safety evidence in stage I trials supporting continuation to stage II trials. Since early in the 1980s, ... The role of the gut-brain axis and the gut flora in Parkinsons became a topic of study in the 2010s, starting with work in germ ... In 2020, a first in human clinical trial reported the transplantation of induced pluripotent stem cells into the brain of a ...
Results of clinical trials are also presented, such as data 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 ... Two daughter journals also exist: JCSM-Clinical Reports started in July 2016 and JCSM-Rapid Communications. Cachexia is a major ...
... s (glutamate modulators) are a new form of antipsychotic that are in Phase II FDA study. The first ... ... 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 ...
Schiebinger L (October 2003). "Women's health and clinical trials". The Journal of Clinical Investigation. 112 (7): 973-7. doi: ... led the FDA to issue regulations in 1977 recommending that women should be excluded from participating in Phase I and Phase II ... This topic alone sparked controversy and brought about question to the medical standard of our time. Popular media has ... "Systematic Review of Gender Bias in the Clinical Trials of New Long-Acting Antipsychotic Drugs". Journal of Clinical ...
Her Ph.D. research focused phase diagram of block copolymers. After completing her Ph.D., Mayes worked two years as Visiting ... When three surgeries and intense chemotherapy failed, she underwent a clinical trial that eradicated the cancer in 1997 but ... Mayes research led to breakthroughs in many topics, including the development of polymeric electrolytes for lithium-ion ...
A phase II clinical trial is recruiting individuals to study how well nivolumab with or without varlilumab works in treating ... Current Topics in Microbiology and Immunology. 390. pp. 365-85. doi:10.1007/978-3-319-22822-8_15. ISBN 978-3-319-22821-1. PMID ... An interventional phase II clinical trial testing the effectiveness and safety of R-CHOP versus R-CHOP plus lenalidomide ( ... A phase I clinical trial is recruiting individuals to study the side effects and efficacy of CD19/CD22 chimeric antigen ...
... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... was reported as showing that the medical profession had responded to the growth of CAM in three phases, and that in each phase ... According to two writers, Wallace Sampson and K. Butler, marketing is part of the training required in alternative medicine, ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ...
Monitoring Board Recommends Early Termination of Ebola Therapeutics Trial in DRC Because of Favorable Results with Two of Four ... "Clinical Microbiology Reviews (Review). 22 (4): 552-63. doi:10.1128/CMR.00027-09. PMC 2772359. PMID 19822888.. ... Current Topics in Microbiology and Immunology. Ebolavirus and other filoviruses. 315. pp. 363-87. doi:10.1007/978-3-540-70962-6 ... The response to the epidemic then moved to a second phase, as the focus shifted from slowing transmission to ending the ...
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... "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 ...
42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk ... The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H-Medical ... When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more ...
"ISIS initiates Phase 3 clinical trials for potential SMA therapy ISIS-SMNrx". The SMA Trust.. ... During World War Two, Demerec directed efforts at Cold Spring Harbor that resulted in major increases in penicillin production. ... Topics. *Contributing property. *Keeper of the Register. *Historic district. *History of the National Register of Historic ... develop a new clinical cancer research unit at Northwell Health in Lake Success, NY, to support early-phase clinical studies of ...
An auditory-motor interaction may be loosely defined as any engagement of or communication between the two systems. Two classes ... Phase-locking to stimulus frequencies has been shown in the auditory nerve,[5][6] the cochlear nucleus,[5][7] the inferior ... Chen, R; Hallett, M (1998). "Focal dystonia and repetitive motion disorders". Clinical Orthopaedics and Related Research (351 ... "Decoding auditory attention to instruments in polyphonic music using single-trial EEG classification". Journal of Neural ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Every Child by Two. * ... molecular basis of immunity will translate to improved clinical ... 41 (2): 303-08. PMC 1537014 . PMID 7438556.. *^ Engineers of small-scale humanised antibody production. Prices on application. ... doi:10.1016/s0264-410x(98)00207-2. PMID 9987167.. *^ Guérin, N. (2007). "Histoire de la vaccination: De l'empirisme aux vaccins ...
... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ... clinical endpoint - clinical latency - clinical practice guidelines - clinical trial - - cloning - CMS - CMV ... This is a list of AIDS-related topics, many of which were originally taken from the public domain U.S. Department of Health ... Community Programs for Clinical Research on AIDS (CPCRA) - community-based clinical trial (CBCT) - community-based organization ...
... none of these strategies have proven to be efficacious in TBI clinical trials [13-15]. The failure of clinical therapy trials ... Temporal protein biomarkers in tracking different phases of TBIEdit. A continuum of protein biomarkers in tracking different ... should be translational in nature with demonstrated evidence that there are similar to biofluid profiles in at least two ... Scholia has a topic profile for Biomarker.. Retrieved from " ...
Two months later, they were found guilty in a jury trial. The producers were fined $200 and the cast received suspended ... Foster suggests that women would have encountered suspicion about their own lives had they used same-sex love as a topic, and ... Although he considered bisexuality inherent in all people, and said that most have phases of homosexual attraction or ... Journal of Consulting and Clinical Psychology, 71 (1), pp. 53-61. ...
... roughly corresponding to the last two years of American high school plus what in the USA would be a two-year Community or ... This system was phased out in 1972-1977 in favor of the modern system where grades 1-9 are mandatory. After the age of 15, the ... "Public Domain on Trial in Reiss-Engelhorn Museum vs. Wikimedia et al. - International Communia Association". Communia- ... A Bachelor of Medicine (lääketieteen kandidaatti, medicine kandidat) is allowed to conduct clinical work under the supervision ...
Related to Bernoulli trials (yes/no events, with a given probability)[edit]. *Basic distributions: *Bernoulli distribution, for ... The probability mass function (pmf) p(S) specifies the probability distribution for the sum S of counts from two dice. For ... List of statistical topics. *Kirkwood approximation. *Moment-generating function. *Quasiprobability distribution. *Riemann- ... The probability distribution of the sum of two independent random variables is the convolution of each of their distributions. ...
The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... multi-year trial did report a nearly two-fold increase in kidney stones in men who regularly consumed a vitamin C supplement.[ ... started publishing research on the topic and also published a book "Vitamin C and the Common Cold" in 1970.[28] A revised and ... "Measurement of intracellular vitamin C levels in human lymphocytes by reverse phase high performance liquid chromatography ( ...
... a phase II trial". Journal of Clinical Oncology. 23 (10): 2332-8. doi:10.1200/JCO.2005.51.008. PMID 15800324.. ... Scholia has a topic profile for Cholangiocarcinoma.. *American Cancer Society Detailed Guide to Bile Duct Cancer. ... a phase II study". Japanese Journal of Clinical Oncology. 35 (2): 68-73. doi:10.1093/jjco/hyi021. PMID 15709089.. ... "Phase II study of erlotinib in patients with advanced biliary cancer". Journal of Clinical Oncology. 24 (19): 3069-74. doi: ...
... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ... Bradley's Neurology in Clinical Practice: Expert Consult - Online and Print, 6e (Bradley, Neurology in Clinical Practice e- ... Walker, BD (2007 Aug-Sep). "Elite control of HIV Infection: implications for vaccines and treatment.". Topics in HIV medicine ... Estadio II: Síntomas suaves que poden incluír manifestacións mucocutáneas menores e infeccións do tracto respiratorio superior ...
20-year results of a randomized trial". Journal of Clinical Oncology. 32 (8): 791-7. doi:10.1200/JCO.2013.50.6600. PMID ... Nerve damage from ionizing radiation occurs in phases, the initial phase from microvascular injury, capillary damage and nerve ... Wikibooks has a book on the topic of: Radiation Oncology. Information. *Human Health Campus The official website of the ... During the first two weeks after fertilization, radiation therapy is lethal but not teratogenic.[27] High doses of radiation ...
The pooled results of two trials on acupuncture showed a moderate likelihood that there may be some improvement to sleep ... Handbook of Clinical Neurology. 106. pp. 527-40. doi:10.1016/B978-0-444-52002-9.00031-0. ISBN 978-0-444-52002-9. PMID 22608642. ... Delayed sleep phase disorder (DSPD), inability to awaken and fall asleep at socially acceptable times but no problem with sleep ... "UTCAT2395, Found CAT view, CRITICALLY APPRAISED TOPICs". Retrieved 2016-03-08.. ...
... the drug may be used in human clinical trials. Human trials with all of the below HDAC inhibitors are extremely variable and ... Sodium phenylbutyrate phase II human triasl with 12 to 15 g/day showed restored mRNA levels of Htt mutant repressed genes but ... "British Journal of Clinical Pharmacology. 75 (4): 1152-3. doi:10.1111/j.1365-2125.2012.04444.x. PMC 3612735. PMID 22905989.. ... Human trials are extremely variable showing increased SMN2 levels and increased muscle strength in some trials and absolutely ...
CR at three sites for six months to a year in Phase 1 and for two years in Phase 2.[40] ... Institute on Aging and the National Institute of Diabetes and Digestive and Kidney Diseases mounted the CALERIE clinical trials ... "Journal of Clinical Densitometry. 16 (4): 450-454. doi:10.1016/j.jocd.2013.08.010. PMC 5321047. PMID 24063845.. ... "The American Journal of Clinical Nutrition. 88 (1): 1-11. doi:10.1093/ajcn/88.1.1. PMC 2674146. PMID 18614716.. ...
... and has now successfully concluded Phase I clinical trials. There has been some research success towards a "universal flu ... Current Topics in Microbiology and Immunology. 283. pp. 313-42. doi:10.1007/978-3-662-06099-5_9. ISBN 978-3-642-07375-5. . PMID ... Two of whom had died and the third was critically ill. Although the strain of the virus is not thought to spread efficiently ... a meta-analysis of published and unpublished clinical trials". Family Practice. 30 (2): 125-33. doi:10.1093/fampra/cms059. PMID ...
2016). "Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials". JAMA ... The pathophysiology of allergic responses can be divided into two phases. The first is an acute response that occurs ... a collection of resources on the topic of food allergies and intolerances ... Late-phase response[edit]. After the chemical mediators of the acute response subside, late-phase responses can often occur due ...
... it was announced that the two priests will stand trial on 5 August 2019.[323] The two priests will face trial in Argentina,[323 ... "Phase Four: Residential child care establishments run by male religious orders within the Roman Catholic Church". Scottish ... Thomas Plante of the Catholic Santa Clara University and volunteer clinical associate professor at Stanford University states ... Investigation, prevention and victim support related topics. *Broken Rites Australia, support and advocacy group in Australia ...
"Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes". Br J Psychiatry ... Clinical outcome evidence[edit]. A number of studies have been carried out to see whether the early psychosis approach reduces ... but the difference between the two treatments is not clear. Data supporting this finding are based on moderate quality evidence ... where thoughts unrelated to a common topic appear uncontrollably; referential ideation that is immediately corrected; and other ...
"Data sharing platforms for de-identified data from human clinical trials". Clinical Trials: 1740774518769655. doi:10.1177/ ... In Brazil, two universities are pioneers in teaching and research in Medical Informatics, both the University of Sao Paulo and ... Computer models are used to examine various topics such as how exercise affects obesity, healthcare costs, and many more.[35] ... developed computerized systems to automate many aspects of multi-phased health checkups. These systems became the basis the ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Every Child by Two. * ... 2] The same study predicted that a vaccine would be available ... "Clinical Microbiology Reviews. 11 (3): 430-9. doi:10.1128/CMR.11.3.430. PMC 88889. PMID 9665976.. .mw-parser-output cite. ... within 10 years.[2] The current types of vaccines which are in research are particle-based vaccines, attenuated vaccines, ...
Academic clinical trials. *Clinical study design. Controlled study. (EBM I to II-1; A to B). *Randomized controlled trial * ... A Phase I discovery will be followed by Phase II reproductions as a drug develops towards commercial production. In recent ... EBM II-2 to II-3; B to C). *Cross-sectional study vs. Longitudinal study, Ecological study ... decades Phase II success has fallen from 28% to 18%. A 2011 study found that 65% of medical studies were inconsistent when re- ...
... clinical hair loss (telogen effluvium) may occur.[citation needed] A disruption of the growing phase causes abnormal loss of ... There are two types of identification tests for female pattern baldness: the Ludwig Scale and the Savin Scale. Both track the ... Baldness is the partial or complete lack of hair growth, and part of the wider topic of "hair thinning". The degree and pattern ... Dietary supplements are not typically recommended.[30] There is only one small trial of saw palmetto which shows tentative ...
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... Two common salts include aluminium phosphate and aluminium hydroxide. Aluminium salts are the most commonly-used adjuvants in ... Despite the side effects, its potential benefit has led to a few clinical trials.[9] ... As of 2016, several TLR ligands were in clinical development or being tested in animal models as potential adjuvants.[24] ...
and Sanofi affiliate Shantha Biotechnics are currently in Phase III clinical trials.[37][38] ... Two or three doses more than a month apart should be given, depending on the vaccine administered.[2] Because the majority of ... "ROTAVAC clinical trial results , DEFEATDD.ORG - Resources to defeat diarrheal disease". Archived from the ... Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe ...
"ACL Program - Bridge-Enhanced ACL Repair (BEAR) Clinical Trial". Retrieved 25 April 2016.. ... Phase 5[edit]. This is the last phase of the recovery rehabilitation. Phase V includes returning to sports after being cleared ... Here you jump straight in the air from a standing start and land on two feet as stable as possible.. *Heiden Hop Test ... "Anterior Cruciate Ligament (ACL) Injuries - Topic Overview". Retrieved 25 April 2016.. ...
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 ...
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 ...
More news releases in similar topics. * Health Care & Hospitals * Medical Pharmaceuticals * Clinical Trials & Medical ... Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive ... including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data ... today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the ...
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 ...
Larger, prospective studies of markers are needed to assess their clinical value. ... Clinical Trials, Phase II as Topic * Colitis, Ulcerative / diagnosis * Colitis, Ulcerative / drug therapy* ... In the placebo-controlled trial, clinical remission was defined as total Mayo Clinic Score ≤2, with no individual subscore ,1, ... Gaik W Tew 1 , Jason A Hackney 1 , Deena Gibbons 2 , Christopher A Lamb 3 , Diana Luca 1 , Jackson G Egen 1 , Lauri Diehl 1 , ...
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 identifier (NCT number): NCT00495677 ...
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 ...
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 ...
clinical trials Blogs, Comments and Archive News on ... clinical trials Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. ... Bharat biotechs COVID-19 vaccine Covaxin gets DCGI nod for phase 3 clinical trial. 23 Oct, 2020, 09.46 PM IST. The vaccine ... Eli Lilly receives permission to conduct Phase 3 clinical trials for Covid treatment. 05 Nov, 2020, 09.02 PM IST. The Subject ...
Current Topic:. Is BPA Safe Or Not?. The best writers in science tackle sciences hottest topics. ... has started a Phase II clinical trial in adults with acute bacterial skin and skin structure infections (ABSSSI). The trial is ... Novexel Starts Phase II Clinical Trial With NXL103 In Adults With Acute Bacterial Skin And Skin Structure Infections (ABSSSI) ... In late 2008, Novexel announced positive results from a Phase II clinical trial evaluating NXL103 in the treatment of community ...
Serum Institute conducting phase III clinical trial of tuberculosis vaccine: DBT. 27 Jul, 2020, 09.19 PM IST. The BCG vaccine ... had recommended eight amendments to be made to the firms proposal to conduct Phase-II and -III trials. ... These will be used for phase 3 clinical trials conducted in India as well as sold commercially if the vaccine is approved for ... 3 clinical trials in India. 04 Aug, 2020, 08.34 AM IST. According to the proposal, 1,600 people will participate in the trials ...
Phase II Clinical Trials of Novel Therapies for Lung Diseases (UM1) RFA-HL-12-022. NHLBI ... Research topics. Clinical studies must include trials of novel drugs, devices, biologics, or management practices for treatment ... Each application must propose one Phase II clinical treatment trial. In this context, Phase II trials are proof of concept ... The purpose of this FOA is to solicit research applications to conduct Phase II clinical therapeutic trials that have the ...
phase 1 clinical trial (topic). *phase 2 clinical trial (topic). *pleura effusion ... Thermal ablative therapies used in clinical practice to date include Radiofrequency Ablation (RFA), Microwave Ablation (MWA) ...
... the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to ... Clinical Trials as Topic / methods* * Clinical Trials, Phase II as Topic * Clinical Trials, Phase III as Topic ... An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is ... Adaptive design methods in clinical trials - a review Orphanet J Rare Dis. 2008 May 2;3:11. doi: 10.1186/1750-1172-3-11. ...
Antria announced it has gained FDA approval to begin phase 2 clinical trials using its autologous adipose-derived stem cells ... You have already added this topic to your email alerts. Click here to manage your alerts. ... During the second phase of study, Antria plans to incorporate a larger participant group and is set to begin enrollment within ... During the second phase of study, Antria plans to incorporate a larger participant group and is set to begin enrollment within ...
July 10 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation announced today that an advanced Phase I/II clinical trial ... The clinical trial using Rexin-G for pancreatic cancer is the third of three advanced Phase I/II protocols that will be ... California Biotechnology Company Takes Aim at Pancreatic Cancer With an Advanced Phase I/II Clinical Trial Using Rexin-G(TM), a ... California Biotechnology Company Takes Aim at Pancreatic Cancer With an Advanced Phase I/II Clinical Trial Using Rexin-G(TM), a ...
The clinical trials were conducted in partnership with the International Centre for Diarrhoeal Disease Research (ICDDR), ... Interested in the next Webinar on this Topic?. Click here to register your Interest ... India: Hilleman Laboratories Announces Successful Outcome In Phase I/II Clinical Trials Of Two Under Development Vaccines Last ... On October 12, 2017, the Laboratories has announced the successful completion of Phase I/II clinical trial of its two vaccines ...
A novel cancer therapy studied and developed at MCW with promising clinical outcomes is leading to a larger phase II trial to ... "COVID-19 is such a hot topic that publishers are willing to publish without proper vetting, even in the face of retractions ... Novel CAR-T Cell Immunotherapy for Lymphoma Advances to Phase II Clinical Trial Oct 5, 2020 ... Clinical Trials Clinical trials are invaluable in testing new treatments, drugs and technologies. ...
My clinical interests center on pulmonary disorders in the immunocompromised host, such as patients with hematologic ... Clinical Trials Co-Investigated by Alexander I. Geyer. *A Phase II Study of Nintedanib plus Prednisone to Treat Radiation ... Research Topics ... Clinical Trials. Research is integral to our mission at ... and clinical trials help us discover better forms of patient care and treatment. For you, this could mean access to a new ...
Coronavirus Vaccine India: Covaxin, ZyCOV-D move to phase II clinical trials ... Etimes Trending Topics. *SSR Case. *Rhea Chakrabortys Petition. *Ankita Lokhande. *Disha Salian ...
Coronavirus Vaccine India: Covaxin, ZyCOV-D move to phase II clinical trials ... Etimes Trending Topics. *SSR Case. *Rhea Chakrabortys Petition. *Ankita Lokhande. *Disha Salian ... Takht and Bombay Talkie 2. Vicky Kaushal was born on May 16, 1988. ...
Randomized Prospective Phase II Clinical Trial of NVX in Association with Chemoradiation of Glioblastoma SBC: NUVOX PHARMA, L.L ... Topic: 104 ABSTRACT Formation of misfolded protein oligomers in neurons is an early and causative event in a variety of ... SBIR Phase II 2017 Department of Health and Human ServicesNational Institutes of Health ... Phase. *Phase I (29) Apply Phase I filter *Phase II (12) Apply Phase II filter ...
Clinical Expertise *Clinical Trial. *Clinical Trials, Phase II as Topic. *Drugs, Investigational ... Clinical Trials Clinical trials are invaluable in testing new treatments, drugs and technologies. ... We plan to conduct a clinical trial to test this hypothesis in the setting of the cardiac operating room at Childrens ... Were challenging existing models of care with new ideas across the spectrum of discovery-from basic science, to clinical ...
... will be assessed in a clinical study to be overseen by Bayer ... Compugen said the FDA has lifted the clinical hold on PVRIG- ... Targovax Raises $2.2M to Progress Vaccine into Phase II Pancreatic Cancer.... ... Topics *. AllBioprocessingCancerDrug DiscoveryOMICsTranslational MedicineGenome Editing. Drug Discovery ... The Phase I trial is planned to be conducted at multiple centers in the U.S., Compugen said, adding that site initiation ...
Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the ... Top line Phase 2 study results expected to be released in April 2017. ... Two doses of bryostatin, 20ug and 40ug, vs. placebo for 12 weeks are being tested. A total of 148 patients were enrolled into ... The primary endpoint of the trial is the Severe Impairment Battery (SIB) and the secondary endpoints are the Mini Mental State ...
  • The Phase II trial was a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of Recro Pharma's proprietary intranasal formulation of dexmedetomidine, Dex-IN, in adult patients undergoing bunionectomy surgery, initiating dosing of study medication on Post Op Day 1. (
  • The primary efficacy endpoint of the trial was the summed pain intensity difference over 48 hours, SPID48, starting on Post Op Day 1. (
  • The presentation by Dr. Kuntz will include new interim data from ASPIRO out to 48-weeks of follow-up in the earliest treated patients in dose Cohort 1 (1x10 14 vg/kg), and preliminary safety and efficacy data for the sentinel patient treated in dose Cohort 2 (3x10 14 vg/kg). (
  • Kenji Yasukawa , Ph.D., 'Astellas') today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI ® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). (
  • ARCHES is a randomized Phase 3 study evaluating the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients. (
  • Based on the efficacy or toxic effects of the drug / treatment in a Phase -II trial the outcome of the development process could be decided, i.e if a Phase -III trial would be required. (
  • This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. (
  • The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib). (
  • Till the trials are completed successfully for safety and efficacy, vaccines will not be distributed either in India or anywhere else in the world," Adar Poonawalla, Chief Executive Officer, SII, said. (
  • According to Erlinda M. Gordon, M.D., Medical Director of Epeius, the upcoming clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. (
  • The trial will be designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of COM701, both as monotherapy and in combination with a programmed cell death protein 1 (PD-1) inhibitor. (
  • The Phase II trial ( NCT02940626 ) was a double-blind, placebo-controlled, superiority global study conducted at approximately 65 sites, and was designed to assess the efficacy and safety of ASN100 for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients, an indication for which there are no approved therapies. (
  • Phase I trials are not designed to detect efficacy of experimental drugs. (
  • This FOA will not support multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. (
  • Peak efficacy was observed earlier with CF-1, while CF-2 demonstrated a longer overall duration of effect of up to six months. (
  • The authors discuss the results of a phase I and three phase II trials reporting the efficacy of STI571 as treatment for CML patients and propose two simplified algorithms that may help to guide decision-making for the individual patient. (
  • Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019. (
  • Of these, 36 confirmed that the results met the efficacy criteria, and 25 felt the regimen should be evaluated in phase III testing. (
  • The reasons for not initiating a randomized controlled trial included insufficient efficacy, lack of financial support, and limited access to subjects. (
  • GC4419 successfully completed Phase 1 and 2 clinical trials, showing safety and efficacy in preventing SOM in head and neck cancer patients undergoing radiation therapy. (
  • Conventional statistical methods on predefined clinical outcomes at the 18 months final efficacy time point included Alzheimer's Disease Composite Score (ADCOMS), Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), and Clinical Dementia Rating Sum of Boxes (CDR-SB). (
  • In order to examine T-817MA's efficacy and dose response, they moved on to a phase II clinical trial, in late May, on Alzheimer patients being treated with donepezil hydrochloride. (
  • The trial, led by the neurological team at the PNA Center for Neurological Research (PNA), is intended to evaluate the safety and efficacy of our proprietary drug candidate, AEN-100, a once-daily, gastroretentive, sustained-release zinc-based tablet in ALS patients. (
  • The Dutch study of repeated 2-O-methylated phosphorothioate (2OMe) AO administration suggested limited efficacy after 5 weeks of treatment. (
  • Although larger clinical trials are needed for validating their efficacy for the treatment of cognitive impairment and AD, results of animal studies and clinical trials available to date are encouraging. (
  • We investigated the safety and efficacy of combining ibrutinib and rituximab (IR) in previously untreated older pts (age ≥65 years) with MCL in a single center, phase II clinical trial. (
  • A commercial device is several years away, as the safety and efficacy of the device and imaging agent must be documented to win FDA approval for marketing in the U.S. The clinical trials planned for next year will begin to provide that documentation. (
  • Many of these compounds show innovative mechanisms of action, and some have already been tested in placebo?controlled randomized controlled trials, with promising efficacy and safety results. (
  • Adenovirus Vaccine Efficacy Trial Consortium (2013). (
  • With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. (
  • 27, 2020-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today reported positive topline results for the Company's Phase 2 clinical trial evaluating AR-1105 (dexamethasone intravitreal implant) in patients with macular edema associated with retinal vein occlusion. (
  • Fortunately, the ACC research community has generated a growing list of good clinical trials and will continue the trend in 2020. (
  • This update on the patients in the first stage of the second cohort of the Phase 2 clinical trial in HRAS mutant tumors reported that, as of February 28, 2017, the two patients with HRAS mutant SCCHN with objective responses remain on study and are currently at treatment cycle 19 and cycle 12. (
  • We anticipate that additional results from this ongoing Phase 2 trial of tipifarnib in HRAS mutant SCCHN will be available during the second half of 2017. (
  • The results of these clinical trials were presented at the Vaccines for Enteric Disease Conference 2017, held in Albufeira, Portugal. (
  • Arsanis funded the development program for ASN100, ASN-1, and ASN-2-as well as a third monoclonal antibody, ASN-3-through proceeds from an $8 million purchase of company stock by the Bill and Melinda Gates Foundation in April 2017. (
  • Now running for almost two decades, SMi Group are delighted to announce the return of its 17th annual Pain Therapeutics conference, taking place on the 22nd - 23rd May 2017 in London, and featuring a half day post-conference workshop on the 24th May ! (
  • April 12, 2017 - Notice of Informational Webinars for Investigators Applying for NCCIH Clinical Trials. (
  • With TINNET entering its final year of EU funding, the results were published in a special research topic on tinnitus, which turned out to become the most viewed research topic in the journal Frontiers [2] in 2017. (
  • NEW YORK, Dec. 19, 2017 /PRNewswire/ -- Neurotrope, Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that it will present additional clinical findings from its Phase 2 bryostatin trial in patients with advanced AD in a keynote presentation at the Sachs' Neuroscience Innovation Forum on January 7 in San Francisco. (
  • NEW YORK, Dec. 18, 2017 /PRNewswire/ -- Neurotrope, Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced the appointment of Charles S. Ryan, JD, PhD as Chief Executive Officer and Director. (
  • The companies now anticipate the primary completion date for the ARCHES clinical trial to be in late 2018. (
  • Neuralstem announced the positive topline results of Phase 1 stroke study in the 2018 ISSCR (International Society for Stem Cell Research) abstract on June 23, 2018. (
  • The trial will be taking place at Bayi Brain Hospital in Beijing, China, commencing on August 1, 2018. (
  • EMERYVILLE, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight. (
  • IDMC recommends continuation of trial evaluating AXS-05 versus placebo in Alzheimer's disease agitationIDMC recommends no further enrollment to single-agent bupropion arm NEW YORK, Dec. 10, 2018. (
  • DUBLIN , April 27, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced the presentation of clinical data from a Phase 2b investigational study of collagenase clostridium histolyticum (CCH) for the treatment of cellulite. (
  • On June 25, 2018, the US Food and Drug Administration approved a standardized formulation of cannabidiol oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years and older. (
  • Arsanis expects to advance ASN500 into Phase I clinical trials in 2019, Dr. Russo added. (
  • DUBLIN, June 5, 2019 /PRNewswire/ -- The "Global Psoriasis Clinical Trial Pipeline Highlights - 2019" report has been added to's offering. (
  • Date:2/19/2019). (
  • Medicine (Baltimore) 2019;98(2):e14200. (
  • LONDON, ONTARIO - January 17, 2019 - Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova's Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes. (
  • Moderna and the National Institutes of Allergy and Infectious Diseases have initiated a phase 3 trial evaluating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19). (
  •,viruses%20in%20the%20same%20family.&text=Nipah%20virus%20is%20a%20type,transmitted%20from%20animals%20to%20humans. (
  • The comparative Phase II trial with NXL103 is a prospective, multicenter, investigator-blinded, two-arm, parallel group study carried out in adults, either in hospital or as outpatients, with ABSSSI. (
  • We are excited to initiate patient dosing with COM701 in a multicenter Phase I trial, early in the fall," Compugen president and CEO Anat Cohen-Dayag, Ph.D., said in a statement. (
  • Patients with infantile spasms and clinical response to vigabatrin were identified among a multicenter prospective observational cohort of children with TSC. (
  • This Phase 2, randomized, double-blind, parallel-group, placebo-controlled, multi-dose study is expected to be conducted at multiple centers in the United States. (
  • The primary objective of this study is to evaluate the change from baseline in breath methane, as determined by a lactulose breath test, in methane-positive patients with IBS-C after seven days of treatment with one of two formulations of SYN-010 compared with placebo. (
  • A total of 168 patients were randomized and received study medication in the clinical trial, 84 patients in each treatment group. (
  • Revisions were also made to the protocol for EMBARK, a randomized Phase 3 study of enzalutamide plus leuprolide, enzalutamide monotherapy, and leuprolide alone in men with high-risk non-metastatic HSPC. (
  • In this phase the effectiveness and safety of the experimental study drug or treatment is evaluated by controlled studies. (
  • The study drug or experimental treatment is tested on a larger group of people ( 100- 300) compared to a phase I study. (
  • Since this phase of the study is designed to see if the drug works, patients are given the highest dose that does not cause severe side effects (determined from the phase I study) and are closely observed. (
  • We performed a retrospective analysis of data collected from 110 patients with UC who participated in a phase 2 placebo-controlled trial of etrolizumab, as well as from 21 patients with UC or without inflammatory bowel disease (controls) enrolled in an observational study at a separate site. (
  • This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. (
  • An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy. (
  • Within one to two weeks prior to infusion of the study treatment, subjects will receive one dose of chemotherapy. (
  • The primary endpoint of the study is the clinical outcome in the clinically evaluable population at the Test of Cure (TOC) visit (7 days post-therapy). (
  • This comparative Phase II study is expected to recruit a total of 180 patients from approximately 20 sites in the USA and Central America. (
  • The study is expected to be completed in 2010 and is a critical part of Novexel's clinical development plan for NXL103 which is focused on its potential to be used in hospitals and out-patients as an oral agent for the treatment of infections caused by Gram-positive organisms, including MRSA. (
  • Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. (
  • In addition, each application must include at least one basic research ancillary study tightly related to the clinical question. (
  • Each application will propose one Phase II interventional trial that will most likely use physiological or biochemical rather than clinical endpoints along with at least one smaller basic ancillary research study that is tightly related to the clinical question. (
  • During the second phase of study, Antria plans to incorporate a larger participant group and is set to begin enrollment within the next 90 days in Gainesville, Fla. (
  • After successful completion of the preclinical animal studies and obtaining regulatory clearance for human studies, Hilleman Laboratories had initiated a clinical study in April 2016, to establish proof-of-concept for its heat stable Rotavirus vaccine. (
  • Under the IND, Compugen plans to initiate a first-in-human Phase I study in patients with advanced solid tumors and for whom standard of care therapies are currently ineffective. (
  • neurodegenerative diseases including Alzheimer's disease, today announced that it has initiated dosing in the final patient in its randomized, double-blinded, placebo-controlled, Phase 2 study in moderate to severe Alzheimer's disease patients. (
  • We are disappointed that this clinical study was futile despite the survival benefit of ASN100 as compared to placebo observed in preclinical models of pneumonia," Dr. Russo said. (
  • The Phase 2 study, which will be a randomized, double-blind, controlled study, is based on the encouraging results from the open-label Phase 1 safety study. (
  • The seven patients in the CYC202 Phase I study reported with stable disease included patients with adenocarcinoma, adrenal, lung, ovarian, pancreatic, parotid gland and thymus cancers. (
  • The Phase II trial will be conducted by the US-based Thrombolysis in Myocardial Infarction (TIMI) Study Group in suitable heart attack patients, initially at two hospitals in the United States. (
  • Dr Eugene Braunwald, chairman of the TIMI Study Group said: "We are very interested in learning in this Phase II trial whether BB-10153 can successfully lyse clots and provide an acceptable safety profile in terms of bleeding risk. (
  • We are very pleased that the TIMI Study Group will be carrying out the Phase II evaluation of BB-10153 and look forward to working closely with the group and to receiving the benefit of their outstanding experience in this area. (
  • The Thrombolysis in Myocardial Infarction (TIMI) Study Group is an investigative team that has been at the forefront of clinical research in acute coronary syndromes over the past two decades. (
  • The TIMI Study Group organized in 1984 and led by Dr. Eugene Braunwald of Brigham and Women's Hospital in Boston, Mass., is committed to advancing the knowledge and care of patients suffering from acute coronary syndromes by performing clinical research. (
  • We assessed serious adverse events, somatic growth, and respiratory and neurodevelopmental outcomes at visit 1 (4-6 months of CA), visit 2 (8-12 months of CA), and visit 3 (18-24 months of CA) in a prospective longitudinal follow-up study up to 2 years' CA of infants who received MSCs (MSC group). (
  • AUSTIN, Texas, Nov. 20, 2012 /PRNewswire/ -- XBiotech, a privately held biotechnology company, announced positive interim analysis results today from a Phase II study in patients receiving MABp1 to reduce restenosis after percutaneous revascularization of the Superficial Femoral Artery (SFA). (
  • The Phase II clinical study is a randomized, open-label multi-center trial involving some of the most prestigious cardiac hospitals in the country. (
  • Pharm-Olam was hired to support a Phase 3 study of a monoclonal antibody (mAb) and its impact on patients with ventilator-associated pneumonia. (
  • To learn more about this study and our expertise in the conduct of pneumonia clinical trials and infectious disease in general, please see the helpful resources included below. (
  • Initial study showed a puzzling array of laboratory abnormalities, including a prominent alpha-2 globulin "spike" on serum protein electrophoresis. (
  • The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. (
  • For the trials presented in the 1995-1996 period, we searched for subsequent randomized trials in which one treatment arm was similar to that in the phase II study,' Dr. Tannock said. (
  • Moreover, many trial-ending limitations, such as lack of financial support, were known when the researchers first planned the phase II study, implying that they never intended to move their regimens to phase III studies. (
  • A study led by Andrew J. Vickers, PhD, Memorial Sloan-Kettering Cancer Center, analyzed the 'go/no go' decision-making process that determines whether phase II trials move on to definitive phase III testing (Clin Cancer Res 13:972-976, 2007). (
  • Dr. Vickers said that we're facing a relatively new problem: 'A typical phase II study 15 years ago would have examined a cytotoxic agent in late-stage patients.There was no need to use historical data for determining the null hypothesis as we know that few patients would respond in the absence of treatment. (
  • Rivoceranib (also called Apatinib) - Following a promising phase II study carried out in Shanghai, China , several sites will be opening soon in the USA and Korea. (
  • Nivolumab + Ipilumumab + Radiation - Following the completion of two studies of Nivolumab + Ipilumumab , a new study will be testing that immunotherapy combination with radiation. (
  • Other planned large trials, such as Solidarity, stopped enrolling patients to the hydroxychloroquine arm, and the National Institutes of Health- sponsored ORCHID study was also stopped [143,144]. (
  • Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented the latest data from the Phase II clinical study (Study 201) of BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease, at a symposium session titled "Clinical and Biomarker Updates from BAN2401 Study 201 in Early Alzheimer's Disease" held on October 25 at the 11th Clinical Trials on Alzheimer's Disease (CTAD) conference in Barcelona, Spain. (
  • In the United States, Fujifilm Corporation entered into a partnership with the Alzheimer's Disease Cooperative Study (hereinafter "ADCS"), the largest Alzheimer's Disease therapeutic research consortium in the United States, to start a joint phase II clinical trial in June. (
  • Currently the clinical investigators at PNA are conducting a Phase I/II open label study of ALS patients to determine the safety of zinc in conjunction with low doses of copper. (
  • PNA will be presenting the final results from this open-label study at the 22nd International Symposium on ALS/MND in Sydney, Australia from November 30 to December 2, 2011. (
  • As the findings from this study are the basis for our planned clinical trial, we intend to disclose the results concurrent with the presentation at the international symposium. (
  • After conducting further analyses of the results presented in April 2011 from the clinical study evaluating our medical food, reaZin ™, an apparent cognitive benefit was observed in older patients. (
  • Preparations are underway to conduct a larger clinical study of AEN-100 (our zinc-based drug candidate) under an IND application in patients with mild to moderate Alzheimer's disease who are age 70 and older. (
  • It is anticipated that the clinical study will enroll just over 100 patients and that the evaluation period will be at least 12 months. (
  • In April 2011, clinical study results were presented that demonstrated, on average, that the cognitive function of the placebo group, declined over six months in comparison to patients managed with reaZin , a medical food. (
  • The trial would become the largest Phase 2 pemetrexed study with mesothelioma patients to date. (
  • Epizyme indicated that it is continuing to expand enrollment in cohort 6 of the phase II study, which has currently enrolled 44 patients, for a total of at least 60 patients with epithelioid sarcoma. (
  • Elafibranor is currently being evaluated in the clinical Phase 3 study called RESOLVE-IT. (
  • The trial commenced late in 2015 and should be due to disclose a 72-week interim analysis from this pivotal study sometime this summer. (
  • A phase 2 study on a human HTNV/PUUV DNA hantavirus vaccine is ongoing. (
  • NDV-based anticancer therapy has been reported to be of benefit in more than a dozen clinical studies, but the results of these studies must be considered inconclusive because the study designs were weak and the study reports were generally incomplete. (
  • Each site employs a qualified obstetrician/gynecologist (for female-focused sites) or andrologist/urologist (for male-focused sites), study coordinator, and data/research manager, and has access to clinical facilities capable of recruiting for and conducting Phase I, II, and III clinical trials. (
  • Phase II study of GM-CSF secreting allogeneic pancreatic cancer vaccine (GVAX) with PD-1 blockade antibody and stereotactic body radiation therapy (SBRT) for locally advanced pancreas cancer (LAPC). (
  • Phase II trial of karenitecin (BNP1350) in malignant: Clinical and translational study. (
  • The work leading up to the trial was developed in the laboratory in collaboration with Miguel Seabra at Imperial College London and the Phase I study was funded by the Health Innovation Challenge Fund (HICF) - a joint funding partnership between the Wellcome Trust and the Department of Health. (
  • Fujifilm Holdings Corporation is to accelerate the development of the Alzheimer's Disease drug "T-817MA" following the commencement of a Phase II clinical trial in late May by its group company, Toyama Chemical, in Japan. (
  • In the United States last year, Fujifilm decided to conduct a phase II clinical trial jointly with the ADCS, which has extensive experience in the field of Alzheimer's Disease therapeutic research. (
  • Yanxing Chen, Jianfang Zhang, Baorong Zhang and Cheng-Xin Gong, "Targeting Insulin Signaling for the Treatment of Alzheimer's Disease", Current Topics in Medicinal Chemistry (2016) 16: 485. (
  • The purpose of this FOA is to solicit research applications to conduct Phase II clinical therapeutic trials that have the potential to advance development of novel therapies for a lung disease or a cardiopulmonary disorder of sleep. (
  • Thermal ablative therapies used in clinical practice to date include Radiofrequency Ablation (RFA), Microwave Ablation (MWA) and Cryoablation This article will focus on the advantages and limitations of thermal ablative therapy and investigates the potential of a relatively new treatment modality, Electrochemotherapy (ECT), as a novel treatment for lung cancer. (
  • CUR ), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, today announced the initiation of a Phase 2 clinical trial evaluating NSI-566, the Company's lead neural stem cell candidate, as a potential treatment for ischemic stroke. (
  • It covers emerging therapies for Psoriasis in active clinical development stages including early and late stage clinical trials. (
  • All will be important topics for understanding the basic biology of ACC as well as potential new therapies. (
  • Vogelzang explained these therapies, as well as the causes and other approaches to mesothelioma treatment, as the editor of "Malignant Mesothelioma," a comprehensive clinical textbook. (
  • Information gathered from preclinical tests are used to apply for permission to conduct clinical trials. (
  • CCTN was established in 1996 to support research on male and female contraception and to conduct clinical trials of new contraceptive drugs and devices. (
  • To facilitate enrollment in the second stage of our trial we are adding additional clinical sites in Western Europe and Asia, and are working with third party laboratories to facilitate HRAS screening. (
  • The committee recommended that trial enrollment be discontinued. (
  • The trial had an estimated enrollment of 354 patients and an estimated primary completion date of October 8. (
  • Over the past few months, clinical trials of Cabozantinib and the combination of Nivolumab and Ipilumumab have completed enrollment of patients. (
  • This trial was a topic of discussion on the Triple Positive thread, I looked into the trial itself, and went through the enrollment screening and was accepted. (
  • I enrolled in the summer of 2012 right after finishing Herceptin, the enrollment criteria specified starting the trial within 6 months from that point. (
  • The Tazverik data from the ES cohort in Epizyme's phase II trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. (
  • Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in second-line treatment of patients with non-small cell lung cancer: results from an expansion cohort of a phase 1 trial. (
  • The company's pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. (
  • To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit us at . (
  • The report provides Psoriasis pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage. (
  • America's clinical trial pipeline is drying up, with fewer safe and effective new cancer drugs reaching the market. (
  • Speaking on the results Dr. Tarun Sharma, Director R&D at Hilleman Labs said,"The Hillchol" Phase I/II clinical trial results support the Hikojima vaccine design and mirrors the impressive results achieved in preclinical studies. (
  • Bayesian Designs for Phase I-II Clinical Trials describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. (
  • We anticipate initiating the second Phase 2 trial and reporting topline results from the first Phase 2 clinical trial during the second half of 2015. (
  • 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. (
  • We look forward to discussing these Phase II results with the FDA and progressing into pivotal Phase III clinical trials. (
  • In late 2008, Novexel announced positive results from a Phase II clinical trial evaluating NXL103 in the treatment of community acquired pneumonia (CAP). (
  • Positive results for a Phase II trial with NXL103 in the treatment of community acquired pneumonia (CAP) were reported towards the end of 2008. (
  • The results of a first-in-the-world clinical trial of a gene therapy for Fabry disease were published today in the scientific journal Nature Communications. (
  • Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. (
  • That way they cannot be biased in their recording of the results of the trial - how well the medicine worked and whether the patient suffered any side effects. (
  • Positive results in cachexia, psoriasis, and type 2 diabetes have also recently been reported by XBiotech. (
  • compare two or more screening tests to see which test produces the best results. (
  • The results from other clinical trials show what doesn't work or may cause harm. (
  • We are very pleased with the AR-1105 clinical trial results, our first successful clinical trial from our retina program. (
  • As we have previously stated, we do not plan to initiate any new clinical trials for this product candidate until the second half of 2021, after we have seen the results of our other clinical trial programs, including our AR-13503 sustained release implant for wet age-related macular degeneration and diabetic macular edema, and AR-15512 for dry eye. (
  • Medicinova announces positive top-line results from the Sprint-MS phase 2B trial of MN-166 (ibudilast) in progressive MS: achieved both primary endpoints including a significant reduction in whole brain atrophy and safety and tolerability.Medicinova Inc - ‍MN-166 demonstrated a statistically significant reduction in rate of progression of whole brain atrophy compared to placebo in study​.Medicinova Inc - ‍MN-166 was safe and well tolerated in study​. (
  • At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. (
  • A related question is whether perverse incentives encourage researchers to label their results 'positive' without doing the rigorous comparative studies, resulting in trials that produce 'encouraging' results, but ultimately go nowhere. (
  • They reviewed 200 promising phase II trials presented at ASCO meetings in 1995-1996, and 2006, randomly selecting 20 abstracts with encouraging results for each of five cancer sites (breast, lung, GI, GU, and GYN) for each time period. (
  • Looking at the data from 1995-1996, the researchers found that 10 years after presenting phase II trials with promising results, only 13 of 100 regimens were evaluated in phase III testing. (
  • Dr. Tannock said that quite a few phase II trials are undertaken when there is very little likelihood, regardless of their results, that they will lead to a phase III trial. (
  • Based upon these results, we anticipate the opening of an ACC-focused clinical trial in the coming months. (
  • 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). (
  • We are very excited to see that these early clinical results with solithromycin in NASH patients are confirming the results we saw in our pre-clinical studies," said Dr. Prabhavathi Fernandes, president and chief executive officer of Cempra, "and we look forward to continuing to investigate this important unmet medical need. (
  • Based on the results of this 60-patient trial, the company intends to advance Aurexis into an appropriately powered, follow-on Phase II trial in this indication. (
  • Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a phase 3 clinical trial," said NIAID Director Anthony S. Fauci, MD. (
  • Results of population studies and clinical trials. (
  • The summary includes a brief history of NDV research, a review of laboratory and animal studies, the results of clinical trials, and possible side effects of NDV-based therapy. (
  • We continually strive to design and implement clinical trials that bring innovations to people with the greatest need,' said Steven Benner , M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. (
  • Patients enrolled in Phase I studies suffer from many different types of cancer, have typically exhausted other therapeutic alternatives and usually experience low survival. (
  • On November 11, 2011, we announced that our drug candidate, Trimesta, will be utilized in a new randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate its potential therapeutic effect on cognitive dysfunction in women suffering from MS, a major consequence of this disease. (
  • The Company plans to meet with the FDA to discuss the Company's Phase III plans and determine what, if any, additional information will be required in association with the Phase III clinical program for Dex-IN. (
  • 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. (
  • Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. (
  • Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. (
  • Phase -II studies also help determine, risks associated with the drug as well as short term side effects. (
  • can any one give me different names given to different phases in clinical studies? (
  • Larger, prospective studies of markers are needed to assess their clinical value. (
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (
  • In addition to NXL103, Novexel is currently conducting two Phase II studies with NXL104 in combination with the cephalosporin antibiotic ceftazidime (CAZ/104) for serious Gram-negative infections. (
  • Although definitive Phase III trials will not be supported, the proposed studies must provide proof of concept for a novel intervention that has high potential for modifying current treatments and could be disease modifying. (
  • Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. (
  • The purpose of clinical trials is research, so the studies follow strict scientific standards. (
  • For the studies presented in 2006, the researchers sent a questionnaire to the authors asking whether they recommended testing the drug in phase III, whether a phase III was planned, and whether they had the resources (budget, patients, and drugs) to conduct a randomized controlled trial. (
  • however, we found that a large number of phase II studies require historical data to set an appropriate target response. (
  • And many of those trials are not setting the historical target appropriately, and that seems to be associated with outcome of the studies. (
  • In addition, the Past Studies webpage reviews how drugs have performed in previous clinical trials. (
  • On August 25, 2011, George A. Eby, a researcher who has conducted multiple clinical studies of zinc lozenges for the common cold, was appointed as a member of our Scientific Advisory Board. (
  • The Chinese government body which approves clinical studies sponsored by foreign companies in that country has given its go. (
  • The data from this clinical trial show that additional studies of Aurexis as a potential treatment are warranted,' stated Dr. J. John Weems, an infection disease specialist at the Greenville Hospital System and principal investigator of the Phase II trial. (
  • Stocks says animal studies will be conducted and evaluated with the idea of enrolling patients in clinical trials as soon as 2 ½ years from now. (
  • The network also relies on a statistical and clinical coordinating center to monitor trials and coordinate data from its studies. (
  • Dex-IN met the primary endpoint of the clinical trial in demonstrating significant pain relief compared with placebo over 48 hours. (
  • The primary endpoint of the trial is radiographic progression-free survival (rPFS). (
  • The primary endpoint of the trial is metastasis-free survival (MFS). (
  • The primary endpoint of the trial is the Severe Impairment Battery (SIB) and the secondary endpoints are the Mini Mental State Exam (MMSE), Activity of Daily Living (ADL) and Neuropsychiatric Inventory scale (NPI). (
  • Using a prespecified protocol, the researchers conducted a systematic review of phase II trials published in the Journal of Clinical Oncology or Cancer, in the 3 years leading up to June 2005. (
  • Aimed at an audience of scientific leaders and senior specialists in neuroscience, CNS, clinical operations and pharmacology, the 17th annual show will provide a focal point for the industry to assess new innovations in effective and safe pain management . (
  • Additionally, the company will be conducting certain post-marketing activities, such as clinical pharmacology evaluations to determine the effect of tazemetostat on liver function and the effect of CYP3A inhibitors and inducers on the inhibitor to inform aspects of the prescribing information. (
  • He is a Fellow of the Royal College of Pathologists (FRCPath), Royal College of Physicians (FRCP), Faculty of Pharmaceutical Medicine (FFPM) and American College of Clinical Pharmacology (FCP). (
  • The network is funded through contracts and utilizes a scientific advisory committee, composed of outside experts in the fields of basic and clinical contraceptive research, pharmacology, and epidemiology, to advise on research topics and directions. (
  • The two patients with partial responses have now been on treatment with tipifarnib for more than 16 months and 10 months, respectively. (
  • Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. (
  • Phase II clinical trial for Dex-IN, a proprietary intranasal formulation of dexmedetomidine, for the treatment of acute pain in adult patients undergoing bunionectomy surgery. (
  • Recro Pharma is currently developing IV/IM meloxicam, a proprietary, Phase III-ready, long-acting preferential COX-2 inhibitor, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine currently being tested in Phase II, for the treatment of acute post operative pain. (
  • Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient. (
  • NXL103 is currently in a Phase II trial for the treatment of ABSSSI. (
  • Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. (
  • Research is integral to our mission at Memorial Sloan Kettering, and clinical trials help us discover better forms of patient care and treatment. (
  • CYC202 is presently being tested in two international, multicentre Phase IIa clinical trials for the treatment of breast and lung cancer in combination with standard chemotherapy. (
  • The aim of the trial will be to test the ability of BB-10153, given at doses between 1 and 5mg/kg, to lyse (dissolve) clots and restore blood flow in the coronary arteries of heart attack patients and to determine the safety of the treatment, especially with respect to bleeding. (
  • Thousands of patients will take the new medicine, or the best alternative treatment, and the data from these trials will decide if the new medicine is safe and effective enough to be prescribed by doctors for the general population. (
  • When the trial began, HT was already in common use for the treatment of menopausal symptoms. (
  • Phase II clinical trials seek to learn what effect of an experimental treatment has on the particular disease or condition being studied. (
  • The formulation of AR-1105 appears to indicate that this therapy candidate may have the potential to deliver a long-acting treatment for patients with macular edema secondary to retinal vein occlusion," said Michael Singer, M.D., Director of Clinical Research at Medical Center Ophthalmology Associates and Clinical Professors of Ophthalmology at the University of Texas Health Science Center in San Antonio. (
  • Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. (
  • It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. (
  • We believe GC4419 has the potential to address an important unmet medical need in the treatment of cancer patients undergoing radiation therapy, and we look forward to commencing a Phase 3 trial with GC4419 in head and neck cancer patients this year. (
  • If further clinical trials are successful and GC4419 gets FDA approval, Riley says, "there's no reason it could not be used to prevent side effects from radiation treatment of other cancers. (
  • Juan Frias and Philip Newsome: Learn about the agents in phase II and III clinical trials and their potential use in treatment. (
  • The company's ongoing, global, randomized, controlled confirmatory trial evaluating the combination of tazemetostat plus doxorubicin (Adriamycin) compared with doxorubicin plus placebo as a front-line treatment for ES is also underway. (
  • Dr. Sant P. Chawla, who trained at the University of Texas M.D. Anderson Cancer Center, is a renowned expert in sarcoma, and has agreed to serve as principal investigator for all three clinical trials. (
  • Clinical trials are invaluable in testing new treatments, drugs and technologies. (
  • The preclinical and Phase I testing of BB-10153 showed that the drug may overcome the risk of bleeding associated with currently-prescribed thrombolytic drugs. (
  • The report concludes with comprehensive insight on ongoing clinical trials of controlled delivered drugs and future trends which clearly highlights it as one of the most promising market in the modern drug delivery segment. (
  • The conference provided a forum for professionals involved in basic science, clinical research, regulatory affairs, and clinical care to meet and discuss the latest advances related to discovery and development of drugs and devices aimed at improving the management of people with epilepsy. (
  • The report shows that there continues to be a steady flow of potential antiepileptic drugs progressing to clinical development. (
  • There's a CRISPR genome editing boom of sorts going on with as many as 20 human trials being undertaken in several countries. (
  • The Phase I trial is planned to be conducted at multiple centers in the U.S., Compugen said, adding that site initiation activities are currently underway. (
  • Earlier this year Endo announced the initiation of two identical Phase 3 RELEASE * clinical trials. (
  • In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. (
  • The clinical trial using Rexin-G for pancreatic cancer is the third of three advanced Phase I/II protocols that will be conducted by Sant P. Chawla, M.D., in the Epeius Clinical Research Unit in San Marino, CA, and in the Sarcoma Oncology Center in Santa Monica, CA. Two other trials for sarcoma and breast cancer have been approved by the FDA. (
  • The clinical trials were conducted in partnership with the International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh. (
  • Under an up-to-$540 million-plus collaboration launched in August 2013 , Compugen and Bayer jointly pursued preclinical research advancing BAY 1905254, while Bayer is now responsible for clinical development of the candidate. (
  • This new facility integrates the highest standards of clinical practice with opportunities for involvement in leading-edge research. (
  • Clinical trials are one of the final stages of a long and careful research process. (
  • Clinical trials are a key research tool for advancing medical knowledge and patient care. (
  • Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. (
  • Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. (
  • Current research, however, suggests that a 'publish or perish' ethos common among some junior researchers is at least part of the problem, thus producing an overabundance of dead-end phase II trials that divert resources from more promising new compounds that could go from phase III to FDA approval. (
  • A research team, headed by Ian Tannock, MD, professor of medicine, Princess Margaret Hospital and the University of Toronto, Canada, sought to determine how many promising phase II trials actually lead to phase III testing. (
  • Since 2005, ACCRF has been supporting basic and translational research with the ultimate goal of getting good scientific ideas into clinical trials. (
  • The trial, which is the first to be implemented under Operation Warp Speed , is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US. (
  • Frontiers offered such an opportunity for a specialist Research Topic, with 14 associated journals and 24 topic editors representing various tinnitus fields. (
  • The Research Topic on 'Towards an Understanding of Tinnitus Heterogeneity' has now achieved 70 open-access articles (with some more articles currently under revision). (
  • The network is managed through NICHD's Division of Intramural Population Health Research and includes 19 sites for clinical evaluation of new female contraceptives and two sites for male contraceptives. (
  • Atrasentan in Patients With Advanced Renal Cell Carcinoma: A Phase 2 Trial of the ECOG-ACRIN Cancer Research Group (E6800). (
  • The National Heart, Lung, and Blood Institute (NHLBI) and other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. (
  • NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. (
  • The Phase 2 clinical trial (AR-1105-CS201) was conducted at 19 centers in the United States. (
  • Vogelzang incorporates lessons he learned in the laboratory to his clinical practice at the Comprehensive Cancer Centers of Nevada (CCCN). (
  • Chairman of Dr Reddys Laboratories, Satish Reddy said, "We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. (
  • Pune based Serum Institute of India (SII) that is conducting Phase 3 trial of the Oxford Covid-19 vaccine has approached India's drug regulator seeking approval for changes to its protocol to broaden the horizon of the trials. (
  • These will be used for phase 3 clinical trials conducted in India as well as sold commercially if the vaccine is approved for emergency use. (
  • Innovative 12-month PA and NP transition to practice programs in a variety of specialty clinical tracks. (
  • DSM has now completed production of material to Good Manufacturing Practice (GMP) standards for the Phase II trial. (
  • All types of clinical trials contribute to medical knowledge and practice. (
  • BOLD ), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, today announced that new interim data from ASPIRO, the Phase 1/2 clinical trial of AT132 in patients with X-linked Myotubular Myopathy (XLMTM), will be presented at the 23rd International Congress of the World Muscle Society (WMS) in Mendoza, Argentina. (
  • Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. (
  • Josh Silverman , Chairman of the Company, added, "We are pleased with the investor response to our new management team and the excitement surrounding our upcoming clinical data. (
  • Arsanis did not disclose trial data in its announcement. (
  • Clinical trials produce the best data available for health care decisionmaking. (
  • This information is intended for physicians and related personnel, who understand that medical information is often imperfect, and must be interpreted in the context of a patient's clinical data using reasonable medical judgment. (
  • The FDA granted accelerated approval of tazemetostat (Tazverik) based on data reported in a phase II clinical trial of the methyltransferase inhibitor. (
  • Recently, DNAtrix , a Houston biotech, announced a partnership with pharma giant Merck to collaborate in phase II clinical trials of an immunotherapy for gliobastoma, an especially deadly brain cancer for which there is no cure. (
  • Compugen today said clinical trials will be launched for a pair of its cancer immunotherapy candidates targeting advanced solid tumors -its lead immuno-oncology program targeting PVRIG, which had been in clinical hold since April, and another program targeting the ILDR2, or immunoglobulin-like domain-containing receptor 2, protein whose development will be overseen by Bayer. (
  • Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community online and in print. (
  • We focused on design aspects of these trials and how they ultimately affect the phase II to phase III transition,' Dr. Vickers told Oncology NEWS International. (
  • He has served on a number of committees, including the American Society of Clinical Oncology and the Illinois Division of the American Cancer Society. (
  • Recently completed phase 2 and 3 trials have investigated topics such as intraoperative imaging, immunotherapy and chemotherapy combinations for platinum-resistant TP53-mutated epithelial cancers. (
  • Immunotherapy, which involves stimulating a patient's own immune system to better attack and kill cancer cells, is currently a hot topic in cancer drug development, attracting minds and money alike. (
  • Kura Oncology's lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. (
  • en] This review article describes the identification of the tyrosine kinase BCR/ABL as the hallmark of chronic myeloid leukemias (CML) as well as the development of a specific inhibitor of this tyrosine kinase, the STI571 (Glivec, imatinib mesylate). (
  • The approval was based on overall response rate (ORR) and duration of response in a phase II clinical trial of the methyltransferase inhibitor. (
  • Compugen said the FDA has lifted the clinical hold on PVRIG-targeting COM701 that the company disclosed on April 27, saying the agency requested additional chemistry, manufacturing, and control (CMC) information in support of its Investigational New Drug (IND) application. (
  • The Gates Foundation investment came two months after Arsanis won a $9.3 million grant from the foundation in return for the company advancing through to Investigational New Drug (IND) filing an initial candidate from a panel of respiratory syncytial virus (RSV)-targeting antibodies for which Arsanis gave the foundation an exclusive global license. (
  • This follows British Biotech's submission of an Investigational New Drug (IND) application on February 19 this year to conduct a Phase II clinical trial of the drug in acute myocardial infarction (AMI). (
  • Protocol development and drafting of the Investigational New Drug (IND) application are underway to conduct a multi-center, double-blind, placebo-controlled clinical trial for patients suffering from ALS, also known as Lou Gehrig's disease. (
  • Patients who complete this first Phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, Phase 2 extension clinical trial that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels. (
  • The trial is expected to enroll approximately 30,000 adult volunteers. (
  • SAN MARINO, Calif. - July 10 (SEND2PRESS NEWSWIRE) - Epeius Biotechnologies Corporation announced today that an advanced Phase I/II clinical trial using intravenous Rexin-G(TM) for pancreatic cancer that is refractory to standard chemotherapy will open in the summer of 2007 in Los Angeles, California. (
  • We are currently studying GC4419's anti-tumor effect in a Phase 1/2 clinical trial in pancreatic cancer at MD Anderson Cancer Center. (
  • 2016 Feb;150(2):477-87.e9. (
  • Oddo Securities donderdag herhaalde haar aanbeveling 'kopen' en zijn koersdoel tot 46 euro op GENFIT na de publicatie van de financiële resultaten van 2016 het biofarmaceutisch bedrijf. (
  • We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. (
  • and present exclusive new findings from phase II clinical trials. (
  • Both formulations, CF-1 and CF-2, were well tolerated with no unexpected safety findings. (
  • Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product. (
  • Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. (
  • PARIS, November 6 /PRNewswire/ -- Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces today that its most advanced oral antibacterial NXL103 (flopristin/linopristin), has started a Phase II clinical trial in adults with acute bacterial skin and skin structure infections (ABSSSI). (
  • Strategies for the use of adaptive design in clinical development of rare diseases are discussed. (
  • NSI-189, is a small molecule in clinical development for major depressive disorder and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke. (
  • being highlighted at Hot Topics is an important milestone in Endo's development program of CCH for Cellulite as we pursue entry into the Medical Aesthetics community. (
  • The development of T-817MA will continue to be promoted under a clinical trial structure using the same methodology and dosage in both Japan and the United States. (
  • In its 2010 Annual Report that was publicly disclosed in May 2011, Meda stated that flupirtine for fibromyalgia was in Phase II development. (
  • In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. (
  • To determine the long-term safety and outcomes of mesenchymal stem cells (MSCs) for bronchopulmonary dysplasia in premature infants enrolled in a previous phase I clinical trial up to 2 years of corrected age (CA). (
  • In addition, seven CYC202 Phase I patients with various tumors, including pancreas and lung cancer, experienced long lasting tumor stabilization. (
  • Clinical trials are almost always for patients with advanced and progressing disease (metastases or inoperable primary tumors that are growing). (
  • At the end of the trial, over 41 percent of patients experienced a reduction in their tumors. (
  • Arsanis said today it has ended a Phase II trial for its sole clinical-phase candidate, ASN100, concluding that the monoclonal antibody combination would fail to prove its effectiveness in high-risk, mechanically ventilated patients with Staphylococcus aureus pneumonia. (
  • The HillcholTM vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes, and also replaces three virulent O1 strains inactivated by two different processes used in currently licensed vaccines. (
  • We are currently leading a UK multicentre retinal gene therapy clinical trial to treat choroideremia, which has recently become international. (
  • Our goal is to build upon the body of clinical evidence for enzalutamide in an effort to help address the unmet needs of an even broader spectrum of prostate cancer patients. (
  • Clinical application was performed in 2 cases of lung cancer. (
  • 2 were on systemic anticoagulation, 1 pt was on aspirin 81 mg and 1 pt had vitreous surgery), infections (n=2) and 1 pt each due to myocardial infarction, hypertension and chest pain, colitis, joint pains, esophageal cancer (unlikely related to drug) and patient choice). (
  • It was the Mindfulness Based Stress Reduction trial with Moffitt Cancer Center and the University of South Florida School of Nursing. (
  • For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. (
  • I underwent two treatments of Y-90 commercially known as Therasphere spaced about a month apart. (
  • We also have a robust clinical trials program, offering patients the option to access some of the latest treatments before they are widely available elsewhere. (
  • The scope of this work is therefore both laboratory-based and clinical, because although we need to identify new treatments in the laboratory, we also need to test them in the clinical domain. (
  • Approximately 60 patients will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups, including two different SYN-010 dose groups and a placebo group. (
  • Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. (
  • This is the first report of MAB therapy in restensois and fourth clinical indication where the Company's lead candidate, MABp1, has demonstrated strong safety and effectiveness. (
  • Continued approval for this indication is dependent upon verification and description of the clinical benefit in a confirmatory trial. (
  • Search the NHLBI, use the drop down list to select: the entire site, the Health Topics section only, or the News and Resources section. (
  • This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, solicits grant applications from institutions/organizations to conduct proof-of- concept Phase II clinical trials that test a novel intervention for a lung disease or a cardiopulmonary disorder from sleep that has the potential to significantly change clinical management. (
  • A clinical trial can only start when all the necessary approvals have been granted by these bodies. (
  • In Japan, Toyama Chemical launched a phase I clinical trial in 2012, confirming the safety and tolerability of the T-817MA. (
  • In stage 2, 44 patients were randomized 1:1 to receive either CF-1 or CF-2. (
  • Of the 100 investigators who presented a phase II trial in 2006, 42 returned the questionnaire. (
  • Nevertheless the survey showed that only 10 of the investigators planned to undertake phase III trials, with just 8 stating that they had the necessary resources. (
  • Unfortunately,' Dr. Tannock concluded, 'the real purpose of many phase II trials may be to legitimize the use of nonapproved compounds, or to enhance the investigators' CVs. (
  • These are often called randomised-controlled trials, or double-blind trials. (
  • Two doses of bryostatin, 20ug and 40ug, vs. placebo for 12 weeks are being tested. (
  • It is estimated that about two million doses of rodent brain or cell-culture derived vaccine are given in China every year. (