Clinical Trials as Topic
Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Clinical Trials, Phase III as Topic
Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.
Clinical Trials, Phase II as Topic
Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
Treatment Outcome
Clinical Trials, Phase I as Topic
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
Research Design
Controlled Clinical Trials as Topic
Works about clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
Double-Blind Method
Randomized Controlled Trials as Topic
Patient Selection
Multicenter Studies as Topic
Clinical Trials, Phase IV as Topic
Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Placebos
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
Clinical Trials Data Monitoring Committees
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
Neoplasms
Clinical Protocols
Prospective Studies
Evidence-Based Medicine
An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)
Follow-Up Studies
Single-Blind Method
Congresses as Topic
Drug Therapy, Combination
Drug Administration Schedule
Sample Size
Pilot Projects
Quality of Life
Review Literature as Topic
Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.
Guidelines as Topic
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
Research Subjects
Biomedical Research
Questionnaires
Outcome Assessment (Health Care)
Meta-Analysis as Topic
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
Cost-Benefit Analysis
A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.
Abstracting and Indexing as Topic
Severity of Illness Index
Practice Guidelines as Topic
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
Combined Modality Therapy
Antineoplastic Combined Chemotherapy Protocols
Endpoint Determination
Risk Factors
Dose-Response Relationship, Drug
Informed Consent
Textbooks as Topic
Survival Analysis
A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.
Reproducibility of Results
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
Risk Assessment
Drugs, Investigational
Placebo Effect
Patient Participation
Data Interpretation, Statistical
Prognosis
Terminology as Topic
Feasibility Studies
Dietary Supplements
Products in capsule, tablet or liquid form that provide dietary ingredients, and that are intended to be taken by mouth to increase the intake of nutrients. Dietary supplements can include macronutrients, such as proteins, carbohydrates, and fats; and/or MICRONUTRIENTS, such as VITAMINS; MINERALS; and PHYTOCHEMICALS.
Disease Progression
Publishing
Pain Measurement
Drug Industry
Interviews as Topic
Survival Rate
Disease-Free Survival
United States Food and Drug Administration
Drug Evaluation
Drug Approval
Stroke
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)
Cross-Over Studies
Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)
HIV Infections
Exercise Therapy
Random Allocation
Patient Satisfaction
Therapeutic Human Experimentation
Intention to Treat Analysis
Internet
Cognitive Therapy
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
Biological Markers
Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc.
Drug Combinations
Infusions, Intravenous
National Institutes of Health (U.S.)
Bias (Epidemiology)
Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.
Retrospective Studies
Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.
Patient Dropouts
Programmed Instruction as Topic
Data Collection
Analysis of Variance
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)
National Cancer Institute (U.S.)
Pain
Research
Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)
Antibodies, Monoclonal, Humanized
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
Drug-Related Side Effects and Adverse Reactions
Chemotherapy, Adjuvant
Drug Evaluation, Preclinical
Statistics as Topic
Predictive Value of Tests
In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.
Treatment Failure
Pregnancy
Health Knowledge, Attitudes, Practice
Kaplan-Meier Estimate
A nonparametric method of compiling LIFE TABLES or survival tables. It combines calculated probabilities of survival and estimates to allow for observations occurring beyond a measurement threshold, which are assumed to occur randomly. Time intervals are defined as ending each time an event occurs and are therefore unequal. (From Last, A Dictionary of Epidemiology, 1995)
Age Factors
Age as a constituent element or influence contributing to the production of a result. It may be applicable to the cause or the effect of a circumstance. It is used with human or animal concepts but should be differentiated from AGING, a physiological process, and TIME FACTORS which refers only to the passage of time.
Immunotherapy
Safety
Translational Medical Research
Decision Making
Pragmatic Clinical Trials as Topic
Cohort Studies
Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.
Program Evaluation
Statistics, Nonparametric
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)
Molecular Targeted Therapy
Neoplasm Staging
Herbals as Topic
Canada
Cardiovascular Diseases
Publication Bias
The influence of study results on the chances of publication and the tendency of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Publication bias has an impact on the interpretation of clinical trials and meta-analyses. Bias can be minimized by insistence by editors on high-quality research, thorough literature reviews, acknowledgement of conflicts of interest, modification of peer review practices, etc.
Communication
Motivation
Sensitivity and Specificity
Ethics Committees, Research
Models, Statistical
Algorithms
Incidence
Genetic Therapy
Recovery of Function
Anti-HIV Agents
Databases as Topic
Ethics, Medical
Evaluation Studies as Topic
Conflict of Interest
A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.
Cancer Vaccines
National Institute on Drug Abuse (U.S.)
Component of the NATIONAL INSTITUTES OF HEALTH. It supports a comprehensive research portfolio that focuses on the biological, social, behavioral and neuroscientific bases of drug abuse on the body and brain as well as its causes, prevention, and treatment. NIDA, NIAAA, and NIMH were created as coequal institutes within the Alcohol, Drug Abuse and Mental Health Administration in 1974. It was established within the NATIONAL INSTITUTES OF HEALTH in 1992.
Myocardial Infarction
Behavior Therapy
Ethics, Research
International Cooperation
Chi-Square Distribution
A distribution in which a variable is distributed like the sum of the squares of any given independent random variable, each of which has a normal distribution with mean of zero and variance of one. The chi-square test is a statistical test based on comparison of a test statistic to a chi-square distribution. The oldest of these tests are used to detect whether two or more population distributions differ from one another.
Multivariate Analysis
Proportional Hazards Models
Administration, Topical
The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example.
Quality Control
Internationality
Drug Therapy
Paclitaxel
Comparative Effectiveness Research
Conduct and synthesis of systematic research comparing interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. (hhs.gov/recovery/programs/cer/draftdefinition.html accessed 6/12/2009)
Postoperative Complications
Health Education
Pain Management
Bookplates as Topic
Labels pasted in books to mark their ownership and sometimes to indicate their location in a library. Private bookplates are often ornate or artistic: simpler and smaller ones bearing merely the owner's name are called "book labels." They are usually pasted on the front endpaper of books. (From Harrod, The Librarians' Glossary and Reference Book, 4th rev ed & Random House Unabridged Dictionary, 2d ed)
Broadsides as Topic
Exercise
Risk Reduction Behavior
Smoking Cessation
Control Groups
Health Promotion
Databases, Factual
Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.
Fluorouracil
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Magnetic Resonance Imaging
MEDLINE
Neoplasm Recurrence, Local
Disease Models, Animal
Regression Analysis
Procedures for finding the mathematical function which best describes the relationship between a dependent variable and one or more independent variables. In linear regression (see LINEAR MODELS) the relationship is constrained to be a straight line and LEAST-SQUARES ANALYSIS is used to determine the best fit. In logistic regression (see LOGISTIC MODELS) the dependent variable is qualitative rather than continuously variable and LIKELIHOOD FUNCTIONS are used to find the best relationship. In multiple regression, the dependent variable is considered to depend on more than a single independent variable.
Australia
Health Care Costs
The actual costs of providing services related to the delivery of health care, including the costs of procedures, therapies, and medications. It is differentiated from HEALTH EXPENDITURES, which refers to the amount of money paid for the services, and from fees, which refers to the amount charged, regardless of cost.
Therapeutic Equipoise
Physical Therapy Modalities
Bibliometrics
Individualized Medicine
Drug Delivery Systems
Netherlands
Attitude of Health Personnel
Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise. (1/13843)
The assessment of symptom palliation is an essential component of many treatment comparisons in clinical trials, yet an extensive literature search revealed no consensus as to its precise definition, which could embrace relief of symptoms, time to their onset, duration, degree, as well as symptom control and prevention. In an attempt to assess the importance of these aspects and to compare different methods of analysis, we used one symptom (cough) from a patient self-assessment questionnaire (the Rotterdam Symptom Checklist) in a large (>300 patient) multicentre randomized clinical trial (conducted by the Medical Research Council Lung Cancer Working Party) of palliative chemotherapy in small-cell lung cancer. The regimens compared were a two-drug regimen (2D) and a four-drug regimen (4D). No differences were seen between the regimens in time of onset of palliation or its duration. The degree of palliation was strongly related to the initial severity: 90% of the patients with moderate or severe cough at baseline reported improvement, compared with only 53% of those with mild cough. Analyses using different landmark time points gave conflicting results: the 4D regimen was superior at 1 month and at 3 months, whereas at 2 months the 2D regimen appeared superior. When improvement at any time up to 3 months was considered, the 4D regimen showed a significant benefit (4D 79%, 2D 60%, P = 0.02). These findings emphasize the need for caution in interpreting results, and the importance of working towards a standard definition of symptom palliation. The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible. A standard definition of palliation for use in the analysis of clinical trials data is proposed, which takes into account aspects of onset, duration and degree of palliation, and symptom improvement, control and prevention. (+info)Patterns of care and survival for adolescents and young adults with acute leukaemia--a population-based study. (2/13843)
We report a population-based study of patterns of care and survival for people with acute leukaemia diagnosed at age 15-29 years during 1984-94 in regions of England and Wales covered by specialist leukaemia registries. There were 879 patients: 417 with acute lymphoblastic leukaemia (ALL) and 462 with acute myeloid leukaemia (AML). For ALL, actuarial survival rates were 43% at 5 years after diagnosis and 37% at 10 years. Survival improved significantly between 1984-88 and 1989-94 for those aged 15-19 at diagnosis. Patients entered in national clinical trials and those not entered had similar survival rates. Survival rates were similar at teaching and non-teaching hospitals and at hospitals treating different numbers of study patients per year. For AML, survival rates were 42% at 5 years after diagnosis and 39% at 10 years. Survival improved significantly between 1984-88 and 1989-94. Patients entered in the Medical Research Council AML10 trial had a higher survival rate than those who were in the earlier AML9 trial. Survival did not vary with category of hospital. We conclude that survival has improved for adolescents and young adults with acute leukaemia but that there is at present no evidence that centralized treatment results in a survival benefit for patients in this age group. (+info)U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. (3/13843)
In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration. The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States. The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases. (+info)Issues in the treatment of active tuberculosis in human immunodeficiency virus-infected patients. (4/13843)
Most HIV-infected patients with tuberculosis can be treated satisfactorily with standard regimens with expectations of good results. Treatment of tuberculosis in these patients has been complicated by the introduction of HAART, which relies on drugs that interfere with the most potent class of antituberculous medications. Rifampin-free regimens or regimens that employ rifabutin may be acceptable strategies for patients who are receiving protease inhibitors, although these regimens have not been rigorously evaluated in patients with AIDS. At present, there is good reason to believe that a 6-month course of a rifabutin-containing regimen or a 9-12-month course of a regimen of streptomycin, isoniazid, and pyrazinamide should be adequate therapy for most patients with drug-susceptible disease. As the treatment of HIV infection with antiretroviral agents evolves, the treatment of tuberculosis in patients with AIDS is likely to evolve as well. This will require careful coordination of antituberculosis and antiretroviral therapies. (+info)Contralateral fracture of the proximal femur. Implications for planning trials. (5/13843)
In three consecutive years 462 patients over the age of 60 years presented at Waikato Hospital, Hamilton, New Zealand, with a fracture of the proximal femur. Within two years, 11 (2.4%) returned with a fracture of the contralateral femur. If the effectiveness of any form of treatment aiming at reducing the incidence of contralateral fracture were subjected to a trial, a sample size of 5000, randomly distributed equally between treatment and placebo groups, would be needed for the trial to have a power of 80% to detect a reduction. (+info)Advances in therapy of multiple myeloma: lessons from acute leukemia. (6/13843)
This paper traces the lack of progress, until recently, in the treatment of multiple myeloma (MM) to having ignored the principles that led to cure in acute leukemia more than 2 decades ago. Only in the mid-1980s did investigation begin to consider complete remission (CR) a research objective, representing a necessary first step toward cure. The experience with autologous and allogeneic stem cell-supported high-dose therapy is reviewed, demonstrating, in both historically controlled and randomized studies, the validity of the dose-response concept in MM in terms of increased CR rates as well as extended event-free (EFS) and overall survival (OS). Avoidance of hematopoietic stem cell-damaging agents, especially melphalan, nitrosoureas, and ionizing radiation to marrow-containing sites, assures the ability of peripheral stem cell collection of high quality and quantity, providing rapid engraftment so that mortality is well under 5% following high-dose melphalan (200 mg/m2). This treatment can be applied safely to patients even >70 years of age and in the presence of renal failure. Tandem autotransplants after multiregimen induction have yielded CR rates in the 40% range with median durations of EFS and OS of 43 and 62 months, respectively. Certain chromosomal abnormalities (11 and 13; and translocations) represent the dominant adverse prognosticator for EFS and OS, confirmed in over 500 patients including those with prior therapy. Allogeneic transplants, possible in less than 10% of MM patients, are associated with a 50% mortality during the first year and, unfortunately, late relapses; thus, this approach should be reserved for patients with high-risk disease early in their management. A risk-based treatment algorithm that matches a patient's disease risk with the risk of intervention is presently used, followed by bisphosphonate therapy, not only to delay the onset of MM-related bone disease but also to induce tumor cell apoptosis, indirectly or directly, by down-regulation of cytokines with antiapoptotic activities. Although many patients relapse, this author subscribes to his mentor's motto: "Be Prepared for Success!". (+info)Drug development in solid tumors: personal perspective of Dr. Emil J Freireich's contributions. (7/13843)
The development of chemotherapy for patients with the major cancers progressed from the initial success attained in the treatment of acute leukemias and choriocarcinoma. Many of the principles of therapy were based on the concepts developed in the experimental laboratories and early clinical studies done at the NIH Clinical Center and other centers around the country. The purpose of this review is to describe some of the early advances in cancer therapy and show how many are based on the efforts of Dr. Emil J Freireich. Over his career, Dr. Freireich has published more than 500 papers and worked on more than 70 different drugs and combinations. The principles defined by Dr. Freireich, namely, the use of intermittent intensive chemotherapy to induce complete remissions (CRs), intensification of therapy in remission, and the use of unmaintained remissions to assess cure, have been important in developing curative chemotherapy programs in patients with acute leukemias. These same principles were applied to combination therapy of Hodgkin's disease as the nitrogen mustard, vincristine, procarbazine, and prednisone combination was developed. This led to the high CR and cure rate for this disease. The treatment of metastatic breast cancer does not produce a high proportion of CRs, and cures of metastatic disease are unlikely with chemotherapy alone. But adjuvant chemotherapy after surgery has resulted in a significant reduction in cancer mortality. Many challenges remain in increasing the cure rate for the major solid tumors. New avenues of controlling cell growth and metastases need to be explored. One approach that is exploitable is the use of drugs or nutrients to prevent cancer. Laboratory approaches are now becoming a clinical reality. (+info)Can we cure indolent lymphomas? (8/13843)
The current consensus is that indolent lymphomas are incurable disorders. There are some indications that these malignancies are potentially curable. Indeed, not all indolent lymphomas are currently incurable. For example, patients with Ann Arbor stage I-II indolent lymphomas can experience long-term disease-free survival and probable cure. Also, from the available literature data, it seems that the achievement of a molecular complete remission is a desirable objective. Patients who achieve a persistently negative PCR state seldom relapse, whereas the opposite is true for persistently positive cases. In view of its excellent correlation with disease-free survival when examined serially in multiple blood or marrow samples, the PCR technique has the potential of providing a tumor marker that can be used as an early end point for clinical trials. By serving as an early surrogate end point, PCR could play an important role in expediting the development of new treatment strategies. Whether IFN is capable of increasing the molecular complete remission rate as measured by PCR is not known. However, it is clear that from the clinical standpoint, IFN has been able to increase 2-fold the length of remission in patients with advanced indolent lymphomas. In at least two studies, this has been associated with prolongation of survival. More intensive regimens such as alternating triple therapy, when used in combination with IFN, seem to have improved the quality of remissions as judged by the PCR assay. Finally, the site where the bcl-2 breakpoint occurs seems to have clinical significance. Those follicular lymphomas with germ-line bcl-2, in our experience, have behaved more aggressively than the others, and their failure-free survival seems different from the usual indolent lymphomas and more closely resembles the large cell lymphomas. Although the biological significance of this observation is not yet understood, this group might actually constitute a prognostically different subset with a more aggressive and perhaps more curable lymphoma. Whether the plateau observed in their failure-free survival curve will be maintained with more follow-up and whether they might be a curable subset remain to be determined. (+info)
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Out of sight but not out of mind: how to search for unpublished clinical trial evidence | The BMJ
Phenylketonuria (PKU) Global Clinical Trials Review To 2016 : Latest Report By Radiant Insights,Inc - Get News
Clinical Trial Enrollment Unit - Clinical Cardiovascular Research Center (CCRC) - University of Rochester Medical Center
Breast cancer clinical trial looks at targeting cancer stem cells | Michigan Medicine
UROCIDIN™ PHASE III CLINICAL TRIAL RESULTS TO BE PRESENTED AT EAU AND AUA CONFERENCES
How to Conduct Clinical Trials in Children: A Tutorial. by Valentina Shakhnovich, Christoph P. Hornik et al.
Enrollment Planning and Patient Recruitment
Strabismus Global Clinical Trials Review, H1, 2015
When clinical trial results just say no / Biotech companies often are able to bounce back from seeming disaster, thanks to...
Digging into the Moderna Vaccine Clinical Trials Protocols and Results | Richard Jaffe, Esq.
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Huntingtons Disease Clinical Trials Corner: April 2020 - IOS Press
Clinical trial management system - Wikipedia
Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood...
Bionic eye clinical trial results show long-term safety, efficacy vision-restoring implant
The challenge of ethical issues discussed at Paediatric Clinical Trials 2017
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study - Centre for Evidence...
Rare Cancer News & Clinical Trials » Trial - Brain Tumor » Neurophysiological Evaluation of Training Effect on Cancer-Related...
Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions - PDF
Spain: Proposed New Legislation on Clinical Trials | Inside EU Life Sciences
ACRP To Celebrate International Clinical Trials Day By Recognizing Clinical Research Professionals
Recently released market study: Candidiasis Global Clinical Trials Review, H1, 2012
42-25 NCI Surgery Branch Resumes Enrollment In Suspended Immunotherapy Trials - The Cancer Letter Publications
...
Study | Pediatric Trials Network
Clinical Trial Transparency Remains a Global Issue as NIH Issues a Notice of Proposed Rulemaking on Clinical Trials...
Merv Sheppards Transplant Network: Pfizer Provides Easier, Broader Access to Clinical Trial Information
Researchers Nix HIV Vaccine Clinical Trial Over Disappointing Results - HIVRNA.com
Ascites Market Review H1, 2016 Growth & Analysis, Forecasts | Healthcare
Applied Statistics in Biomedicine and Clinical Trials Design - Collectif - Medecine
AmerisourceBergen launches trial recruitment network AdvanceIQ | FierceBiotech
A systematic review of adverse event reporting in companion animal clinical trials evaluating cancer treatment<...
New Medical Therapies Trial Results in COPD (Chronic Obstructive Pulmonary Disease) | CenterWatch
New Medical Therapies Trial Results in Carotid Artery Disease | CenterWatch
Ruthigen Announces First Patient Enrollment in the Phase 1/2 Human Clinical Trial of RUT58-60, a Broad-Spectrum Anti-Infective...
Current Clinical Trials With STI571
Microbicides for sexually transmitted diseases
"VivaGel™ - Clinical trials Under Way". Star Pharma. Archived from the original on 7 January 2008. Retrieved 1 April 2018. ... World Health Organization (2002). "HIV/AIDS Topics: Microbicides". Geneva: World Health Organization. Retrieved August 28, 2006 ... "Microbicide Clinical Trials". AVAC. Archived from the original on 16 July 2011. Retrieved 1 April 2018. Global Campaign for ... Additionally, clinical trials have not demonstrated these agents to be effective at preventing HIV transmission.[citation ...
Connected health
Safer and more effective clinical trials. Evolution[edit]. This section may stray from the topic of the article. Please help ... "Journal of Evaluation in Clinical Practice. 18 (1): 56-62. doi:10.1111/j.1365-2753.2010.01522.x. ISSN 1365-2753. PMID 20698917. ...
Hyperpolarized carbon-13 MRI
"Clinical Trials". Lupo JM, Chen AP, Zierhut ML, Bok RA, Cunningham CH, Kurhanewicz J, Vigneron DB, Nelson SJ (February 2010). " ... Topics in Magnetic Resonance Imaging. 25 (1): 31-7. doi:10.1097/RMR.0000000000000076. PMC 4968075. PMID 26848559. " ... The majority of clinical studies utilizing 13C hyperpolarization are currently studying pyruvate metabolism in prostate cancer ...
American Association for Cancer Research
... clinical research including clinical trials; endocrinology; epidemiology and prevention; experimental therapeutics, molecular ... Some of the topics include biochemistry; chemical, physical, and viral carcinogenesis and mutagenesis; ... Educational Workshops that train early-career investigators in clinical trial design, molecular biology, integrative molecular ... Based in Philadelphia, the AACR focuses on all aspects of cancer research, including basic, clinical, and translational ...
Imetelstat
2020). "Telomerase-based Cancer Therapeutics: A Review on their Clinical Trials". Current Topics in Medicinal Chemistry. 20 (6 ... It is the first telomerase inhibitor to enter clinical trials. It is currently in Phase 2/3 trials for various cancer types. ...
Paolo Zamboni
On this topic he conducted several randomized clinical trials and published books. In 2015 the Cochrane Review published an ... compression treatment: a randomized clinical trial". European Journal of Vascular and Endovascular Surgery. 25 (4): 313-318. ... "A phase II randomized clinical trial for the treatment of recalcitrant chronic leg ulcers using centrifuged adipose tissue ... Space trials involved the Italian astronaut Samantha Cristoforetti. Zamboni also described other anomalies of cerebral venous ...
Pemetrexed
Clinical Cancer Research; Clinical Trials. 6 (7): 2677-84. PMID 10914709. Avendano, Carmen; Menendez, J. Carlos (April 2008). ... Cancer Topics - Coping with Cancer. National Cancer Institute. Retrieved 1 December 2008. McLeod HL, Cassidy J, Powrie RH, ... In clinical trials for mesothelioma, folic acid and B12 supplementation reduced the frequency of adverse events.) It is also ... NCCN Clinical Practice Guidelines in Oncology: Non-small Cell Lung Cancer V.2.2009 available from www.nccn.org Gandhi, Leena; ...
Virus
... developed using viral vectors and a number of pharmaceutical proteins are currently in pre-clinical and clinical trials.[241] ... Current Topics in Microbiology and Immunology. 2008;325:263-79. doi:10.1007/978-3-540-77349-8_15. PMID 18637511. ... Having completed successful clinical trials, this virus is expected to gain approval for the treatment of a skin cancer called ... Current Topics in Microbiology and Immunology. 2006;304:17-29. doi:10.1007/3-540-36583-4_2. PMID 16989262. ...
Nausea
... a systematic review of randomized clinical trials" (PDF). British Journal of Anaesthesia. 84 (3): 367-71. doi:10.1093/ ... Over 30 definitions of nausea were proposed in a 2011 book on the topic. Nausea is a non-specific symptom, which means that it ... "Bulimia Nervosa-Topic Overview". WebMD. Archived from the original on 25 July 2012. Retrieved 26 July 2012. The dictionary ... a meta-analysis of randomized controlled trials". Acta Anaesthesiologica Scandinavica. 46 (3): 238-44. doi:10.1034/j.1399- ...
Discovery and development of beta-blockers
Lechat, P. (2008). "Clinical pharmacology of beta-blockers in cardiology: trial results and clinical applications". Hot Topics ... Clinical trials started in the summer of 1964 and a year later, propranolol was launched under the trade name Inderal, only two ... The launch took place in November 1963 when many small-scale clinical trials had proved their effectiveness in angina and ... Although DCI had no clinical utility, a change in the compound did provide a clinical candidate, pronethalol, which was ...
Pruvanserin
It was in phase II clinical trials in 2008 but appears to have been discontinued as it is no longer in the company's ... Teegarden BR, Al Shamma H, Xiong Y (2008). "5-HT(2A) inverse-agonists for the treatment of insomnia". Current Topics in ... "Efficacy Study of LY2422347 to Treat Insomnia - Full Text View - ClinicalTrials.gov". "Eli Lilly and Company » Research ...
Allergy
Clinical trials have been initiated to test the effectiveness of certain worms in treating some allergies. It may be that the ... For more information on this topic, see Helminthic therapy. In the early stages of allergy, a type I hypersensitivity reaction ... The authors concluded that, based on rigorous clinical trials of all types of homeopathy for childhood and adolescence ailments ... systematic review of randomized clinical trials". Mayo Clinic Proceedings. 82 (1): 69-75. CiteSeerX 10.1.1.456.5352. doi: ...
Sunnybrook Health Sciences Centre
Various clinical trials are also run out of the centre. Research is conducted through the Odette Cancer Centre research program ... Research spans from the topics of basic genetics, biochemistry and biology of cancer. The program provides critical care and ... "About clinical trials - Odette Cancer Centre - Sunnybrook Hospital". sunnybrook.ca. Retrieved February 14, 2018. "Odette Cancer ...
Dietary fiber
In preliminary clinical trials, they have proven effective for the treatment of irritable bowel syndrome.[60] Examples of ... In: Spiller GA (ed) Topics in dietary fiber research. Plenum Press, New York, pp. 127-68 ... controlled trial". Clinical Gastroenterology and Hepatology. 3 (4): 358-69. doi:10.1016/S1542-3565(04)00672-X. PMID 15822041.. ... "The Journal of Clinical Endocrinology and Metabolism. 97 (9): 3326-32. doi:10.1210/jc.2012-1513. PMID 22745235.. ...
Gender bias in medical diagnosis
Schiebinger L (October 2003). "Women's health and clinical trials". The Journal of Clinical Investigation. 112 (7): 973-7. doi: ... This topic alone sparked controversy and brought about question to the medical standard of our time. Popular media has ... "Systematic Review of Gender Bias in the Clinical Trials of New Long-Acting Antipsychotic Drugs". Journal of Clinical ... In 2018 the US FDA released draft guidelines for inclusion of pregnant women in clinical trials. In a 2019 meta-analysis it was ...
The Journal of Rheumatology
Since 1992, the journal has published the proceedings of Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) ... The Journal of Rheumatology is a peer-reviewed medical journal addressing topics in rheumatology and arthritis. It is an ...
Gail Rosseau
Her current research funding is for clinical trials in breast cancer metastasis and idiopathic normal pressure hydrocephalus. ... She is the author of dozens of papers, invited lectures and courses in these topics, including a co-authored white paper with ... She writes and speaks often in the U.S. and abroad on neurosurgical topics. Her most frequent subjects include innovative ... Gail Linskey Rosseau (born c. 1956) is Clinical Professor of Neurosurgery at George Washington University School of Medicine ...
Neuroprotection
Importantly, clinical trials for the drug in patients with ischemic stroke show it to be effective as well as noninvasive. ... Glutamate antagonists are a hot topic of research. Below are some of the treatments that have promising results for the future ...
2-hydroxy-dATP diphosphatase
Karonudib, an MTH1 inhibitor, is currently being evaluated a phase I clinical trial for safety and tolerability. A potent and ... Research into this topic is ongoing. MTH1 is a potential drug target to treat cancer, however there are conflicting results ... This makes it a topic of interest in cancer research, both as a potential method for healthy cells to prevent cancer and a ... "MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class (MASTIFF)". ClinicalTrials.gov. U.S. National ...
Dietary Supplements (database)
... clinical trials; health and adverse effects; fortification; traditional Chinese medicine and other folk/ethnic supplement ... The subset will retrieve dietary supplement-related citations on topics including, but not limited to: chemical composition; ...
Wikipedia:Plain and simple guide for medical editors
See Trivia, and avoid useless statements like "More research is needed". Wikipedia is not a directory of clinical trials or ... To create a new topic, slick [new section] at the top of the page, give the section a title, and leave your comment. New topics ... For example, the results of an early-stage clinical trial are unlikely to be appropriate for inclusion in the Treatment section ... In medicine, primary sources include clinical trials, which test new treatments; secondary sources include meta-analyses, which ...
Pharmacovigilance
... whereas a clinical trial case will typically be assessed for causality by the clinical trial investigator and/or the license ... The CIOMS, a part of the WHO, is globally oriented think tank that provides guidance on drug safety related topics through its ... The variables in a clinical trial are specified and controlled, but a clinical trial can never tell you the whole story of the ... Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies ...
Change control
From the information technology perspective for clinical trials, it has been guided by another U.S. Food and Drug ... In a Good Manufacturing Practice regulated industry, the topic is frequently encountered by its users. Various industrial ... "Guidance for Industry: Computerized Systems Used in Clinical Trials" (PDF). U.S. Food and Drug Administration. April 1999. ...
Statin
... which are much higher than those seen in randomized clinical trials[62] have been the topic of extensive debate and discussion. ... The author of one study argued that adverse events are more common in clinical practice than in randomized clinical trials.[56] ... Norata GD, Tibolla G, Catapano AL (October 2014). "Statins and skeletal muscles toxicity: from clinical trials to everyday ... Randomized controlled trials have found these foodstuffs to reduce circulating cholesterol, but the quality of the trials has ...
Ophthalmology (journal)
... results of clinical trials, and research findings. Ophthalmology also publishes major reviews of specific topics by ... Topics include new diagnostic and surgical techniques, treatment methods, instrument updates, the latest drug findings, ...
Neuroscience
... is also a popular topic of research and has led to several stage III clinical trials. Invasiveness is not an issue here because ... Because of this, only 3.6% of clinical trials in this field have progressed to stage III since the concept of gene therapy was ... This proves further long term in vivo studies are needed to gain enough understanding to allow for successful clinical trials. ... The specific topics that form the main foci of research change over time, driven by an ever-expanding base of knowledge and the ...
Hantavirus vaccine
In addition to Hantavax three more vaccine candidates have been studied in I-II stage clinical trials. They include a ... However, their prospects are unclear List of vaccine topics Seoul virus Gou virus Vaccine-naive Schmaljohn, C. S. (2012). " ... Field trial of an inactivated vaccine against hemorrhagic fever with renal syndrome in humans. Arch Virol. 1990;1(Suppl):35-47 ... "Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever". ClinicalTrials.gov. ...
Tebipenem
It has performed well in clinical trials for ear infection and looks likely to be further developed in future. It is only ... El-Gamal MI, Oh CH (2010). "Current status of carbapenem antibiotics". Current Topics in Medicinal Chemistry. 10 (18): 1882-97 ... Sugita R (June 2013). "Good transfer of tebipenem into middle ear effusion conduces to the favorable clinical outcomes of ...
National Institute for Health and Care Excellence
They work together to assess the evidence for the guideline topic (e.g. clinical trials of competing products) before preparing ... Before an appraisal, the Advisory Committee on Topic Selection (ACTS) draws up a list of potential topics of clinical ... It was set up as the National Institute for Clinical Excellence in 1999, and on 1 April 2005 joined with the Health Development ... The idea of what was originally termed a National Institute for Clinical Excellence took root when Labour came to power in 1997 ...
Alternative medicine
... clinical statisticians and pharmacologists, use clinical trials to reveal such effects, allowing physicians to offer a ... teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[96] and engaging in complex ... Gorski, DH; Novella, SP (September 2014). "Clinical trials of integrative medicine: testing whether magic works?". Trends in ... Hróbjartsson A, Gøtzsche PC (May 2001). "Is the placebo powerless? An analysis of clinical trials comparing placebo with no ...
Ebola
"Clinical Microbiology Reviews (Review). 22 (4): 552-63. doi:10.1128/CMR.00027-09. PMC 2772359. PMID 19822888.. ... Current Topics in Microbiology and Immunology. Ebolavirus and other filoviruses. 315. pp. 363-87. doi:10.1007/978-3-540-70962-6 ... Several trials were conducted in late 2014, and early 2015, but some were abandoned due to lack of efficacy or lack of people ... Kuhn, Jens H. (2008). Filoviruses: A Compendium of 40 Years of Epidemiological, Clinical, and Laboratory Studies. Archives of ...
Hematopoietic stem cell transplantation
Clinical observations[edit]. A study involving 2408 donors (18-60 years) indicated that bone pain (primarily back and hips) as ... "The Only Real Cure Out There, for Now " Archived 30 May 2008 at the Wayback Machine.. CLL Topics, Inc. ... "Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National ... 2008). "Clinical applications of blood-derived and marrow-derived stem cells for nonmalignant diseases". JAMA. 299 (8): 925-36 ...
Medicine
Clinical laboratory sciences are the clinical diagnostic services that apply laboratory techniques to diagnosis and management ... Trial of the Nuremberg trials, Tuskegee syphilis experiment, and others.. Values such as these do not give answers as to how to ... Subspecialties include transfusion medicine, cellular pathology, clinical chemistry, hematology, clinical microbiology and ... Some related clinical specialties include neurology, neurosurgery and psychiatry.. *Nutrition science (theoretical focus) and ...
Mann-Whitney U test
Grissom RJ (1994). "Statistical analysis of ordinal categorical status after therapies". Journal of Consulting and Clinical ... However it would be rare to find so extended a report in a document whose major topic was not statistical inference. ...
Lyme disease
In clinical trials involving more than 10,000 people, the vaccine, called LYMErix, was found to confer protective immunity to ... "CDC - Lyme Disease - NIOSH Workplace Safety and Health Topic". www.cdc.gov. 3 August 2017. Archived from the original on 13 ... "European Journal of Clinical Chemistry and Clinical Biochemistry (Submitted manuscript). 32 (9): 685-9. doi:10.1515/cclm. ... Stanek G, Reiter M (April 2011). "The expanding Lyme Borrelia complex--clinical significance of genomic species?". Clinical ...
Chiropractic
Ernst E (December 2009). "Spinal manipulation for asthma: a systematic review of randomised clinical trials". Respir Med. 103 ( ... List of topics characterized as pseudoscience. *Chiropractic education. *Chiropractic schools. *Councils on Chiropractic ... Ernst E (2009). "Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials". Int J ... Ernst E, Posadzki P (2012). "Reporting of adverse effects in randomised clinical trials of chiropractic manipulations: a ...
Medical device
42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H-Medical ... Fox-Rawlings S,. Gottschalk L.B., Doamekpor L., Zuckerman D.M. (2018) Diversity in Medical Device Clinical Trials: Do We Know ... Journal of Clinical Engineering[79]. University Based Research Packaging InstitutesEdit. *University of Minnesota - Medical ...
Herbal tea
... a randomized placebo-controlled 25-week outpatient trial". Pharmacopsychiatry. 30 (1): 1-5. doi:10.1055/s-2007-979474. PMID ... Journal of Clinical Psychopharmacology. 20 (1): 84-9. doi:10.1097/00004714-200002000-00014. PMID 10653213.. ...
Kent Holtorf
"American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of ... Further randomized controlled trials are needed to delineate these differences more clearly." The conclusions were contrary to ... FFC). Holtorf has published a number of endocrine reviews on complex topics in peer-reviewed journals on controversial diseases ... Clinical Practice Guidelines by the Infectious Diseases Society of America". Clinical Infectious Diseases. 43 (9): 1089-134. ...
Juris Doctor
"Circular authorizing Peking University to offer the international Fa Lv Shuo Shi on a trial basis" (PDF). Academic Degree ... implementing elements such as clinical training, which has become an essential part of legal education in the U.S. and in the J ... took on a more central role in the preparation of lawyers and consequently improved their coverage of advanced legal topics to ...
Good clinical practice
The Medicines for Human Use (Clinical Trials) Regulations 2004. *The Medicines for Human Use (Clinical Trials) Amendment ... ICH Topic E 6 (R2). *Good Clinical Practice (from U.S. Food and Drug Administration) ... The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the ... clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. ...
Ginger
... a systematic review of randomized clinical trials". Br. J. Anaesth. 84 (3): 367-371. doi:10.1093/oxfordjournals.bja.a013442. ... A systematic review of clinical trials". Pain Medicine. 12 (12): 1808-18. doi:10.1111/j.1526-4637.2011.01261.x. PMID 22054010. ...
Health professional
These include psychiatrists, psychiatry physician assistants, clinical psychologists, occupational therapists, clinical social ... https://www.cdc.gov/tb/topic/infectioncontrol/pdf/healthCareSettings-assessment.pdf *^ https://www.cdc.gov/tb/topic/basics/ ... and active training reduce the risk of contamination but that more randomized controlled trials are needed for how best to ... These include physiatrists, physician assistants, rehabilitation nurses, clinical nurse specialists, nurse practitioners, ...
Cold Spring Harbor Laboratory
"ISIS initiates Phase 3 clinical trials for potential SMA therapy ISIS-SMNrx". The SMA Trust.. ... Topics. *Contributing property. *Keeper of the Register. *Historic district. *History of the National Register of Historic ... develop a new clinical cancer research unit at Northwell Health in Lake Success, NY, to support early-phase clinical studies of ... In 2014, Phase 3 trials begin for drug to treat spinal muscular atrophy (SMA), a neurodegenerative disease, based on Adrian ...
Alzheimerova bolest
2004). "Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials". Arch. ... http://www.nia.nih.gov/alzheimers/topics/symptoms. pristupljeno 28 December 2011. ... 4,0 4,1 4,2 4,3 4,4 Förstl H, Kurz A. Clinical Features of Alzheimer's Disease. European Archives of Psychiatry and Clinical ... 2,0 2,1 2,2 2,3 2,4 2,5 2,6 2,7 2,8 Burns, A; Iliffe, S (5 February 2009). "Alzheimer's disease.". BMJ (Clinical research ed.) ...
Neuroscience of music
Chen, R; Hallett, M (1998). "Focal dystonia and repetitive motion disorders". Clinical Orthopaedics and Related Research (351 ... "Decoding auditory attention to instruments in polyphonic music using single-trial EEG classification". Journal of Neural ... Topics. *Absolute pitch. *Auditory illusion. *Auditory imagery. *Background music. *Consonance and dissonance ... Electroencephalography and Clinical Neurophysiology. 54 (6): 642-53. doi:10.1016/0013-4694(82)90118-3. PMID 6183097.. ...
Healthcare in Cuba
Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. Free ... Basic work teams within the polyclinics supervise and evaluate the neighborhood and clinical health work of the family medicine ... role combine the importance of focusing on both public health and clinical medicine.[38] ...
Ken Strauss
Parkes, B. Ginsberg, R. Jamal, A. Frid, Ultra-short (5mm) insulin needles: trial results and clinical recommendations. ... Strauss speaks frequently to audiences throughout Europe, Africa and the Middle East on topics related to diabetes, HIV disease ... Clinical Immunology and Immunopathology, 1994; 70:152-158. K. Strauss, I. Hannet, S. Engels, A. Shiba, D. Ward, S. Ullery, M. ... Clinical Immunology and Immunopathology, 1997:122-128. F. Hulstaert, I. Hannet, V. Deneys, V. Munhyeshuli, T. Reichert, M. ...
Artificial induction of immunity
List of vaccine topics. *#WHO-EM. *‡Withdrawn from market. *Clinical trials: *†Phase III ... It is hoped that further understanding of the molecular basis of immunity will translate to improved clinical practice in the ...
Index of HIV/AIDS-related articles
... clinical endpoint - clinical latency - clinical practice guidelines - clinical trial - clinicaltrials.gov - cloning - CMS - CMV ... This is a list of AIDS-related topics, many of which were originally taken from the public domain U.S. Department of Health ... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ... Community Programs for Clinical Research on AIDS (CPCRA) - community-based clinical trial (CBCT) - community-based organization ...
Biomarker
... none of these strategies have proven to be efficacious in TBI clinical trials [13-15]. The failure of clinical therapy trials ... Scholia has a topic profile for Biomarker.. Retrieved from "https://en.wikipedia.org/w/index.php?title=Biomarker&oldid= ... Status and relevance for clinical trials". Mov. Disord. (Review). 33 (4): 528-36. doi:10.1002/mds.27355. PMID 29624752.. ... "British Journal of Clinical Pharmacology. 59 (5): 491-494. doi:10.1111/j.1365-2125.2005.02435.x. PMC 1884846. PMID 15842546.. ...
Lesbian
Foster suggests that women would have encountered suspicion about their own lives had they used same-sex love as a topic, and ... Two months later, they were found guilty in a jury trial. The producers were fined $200 and the cast received suspended ... Journal of Consulting and Clinical Psychology, 71 (1), pp. 53-61. ... Between 1955 and 1969 over 2,000 books were published using lesbianism as a topic, and they were sold in corner drugstores, ...
Honey bee
A systematic review of randomised clinical trials". BMJ Open. 4 (11): e006140. doi:10.1136/bmjopen-2014-006140. PMC 4225238. ... Bee venom is under laboratory and clinical research for its potential properties and uses in reducing risks for adverse events ... there are no approved clinical uses for these products which carry various warnings for potential allergic reactions.[82] ... Topics. *Evolution of eusociality. *Presociality. *Social insects *Gamergate. *Group selection. *Haplodiploidy. *Identity in ...
Education in Finland
"Public Domain on Trial in Reiss-Engelhorn Museum vs. Wikimedia et al. - International Communia Association". Communia- ... A Bachelor of Medicine (lääketieteen kandidaatti, medicine kandidat) is allowed to conduct clinical work under the supervision ... Wikipedia articles that may have off-topic sections from January 2019. *Articles that may contain original research from July ... All articles that may have off-topic sections. * ...
Probability distribution
Related to Bernoulli trials (yes/no events, with a given probability)[edit]. *Basic distributions: *Bernoulli distribution, for ... List of statistical topics. *Kirkwood approximation. *Moment-generating function. *Quasiprobability distribution. *Riemann- ... 10.4 Related to Bernoulli trials (yes/no events, with a given probability) ... the outcome of a single Bernoulli trial (e.g. success/failure, yes/no) ...
Vitamin C
The earliest publication of a controlled clinical trial appears to be from 1945.[27] Researchers continued to work on this ... started publishing research on the topic and also published a book "Vitamin C and the Common Cold" in 1970.[28] A revised and ... A meta-analysis of 44 clinical trials has shown a significant positive effect of vitamin C on endothelial function when taken ... cannot be recommended outside of a clinical trial."[43] A 2015 review added: "There is no high-quality evidence to suggest that ...
Cholangiocarcinoma
... a phase II trial". Journal of Clinical Oncology. 23 (10): 2332-8. doi:10.1200/JCO.2005.51.008. PMID 15800324.. ... Scholia has a topic profile for Cholangiocarcinoma.. *American Cancer Society Detailed Guide to Bile Duct Cancer. ... American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 35 (36): e194- ... and enrollment in clinical trials is often recommended when possible.[76] Chemotherapy agents used to treat cholangiocarcinoma ...
Funding of science
Standards for Clinical-Trial Agreements with Industry". New England Journal of Medicine. 352 (21): 2202-2210. doi:10.1056/ ... researchers from different areas who are brought together for several days of intensive discussions about a particular topic ... They further criticized the trial methodology stating that researchers are frequently restricted from contributing to the trial ... on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to ...
SIDA, a enciclopedia libre
Bradley's Neurology in Clinical Practice: Expert Consult - Online and Print, 6e (Bradley, Neurology in Clinical Practice e- ... Walker, BD (2007 Aug-Sep). "Elite control of HIV Infection: implications for vaccines and treatment.". Topics in HIV medicine ... placebo-controlled phase 3 trial". The Lancet 381 (9883): 2083-2090. doi:10.1016/S0140-6736(13)61127-7.. ... Evian, Clive (2006). Primary HIV/AIDS care: a practical guide for primary health care personnel in a clinical and supportive ...
Clinical Trials by Topic
Please find clinical trials at HSS listed by the following topics or view the full directory. ... APS ACTION (Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking) International Clinical ... Please visit the Mary Kirkland Center for Lupus Research and the Lupus Clinical Trials Consortium for more information on lupus ... Non-orthopedic and non-rheumatologic clinical trials are conducted at Weill Cornell Medical College, an affiliate of Hospital ...
TSN: Search for Topics=Clinical Trials
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy - Full Text View - ClinicalTrials.gov
Interventional (Clinical Trial) Actual Enrollment :. 44 participants. Allocation:. Randomized. Intervention Model:. Parallel ... Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy. The safety and scientific validity of this ... MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders Drug Information available for: Tromethamine Ketorolac ... Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient. ...
Search of: stem cell Spinal Cord Injury AND transplantation - Results by Topic - ClinicalTrials.gov
"Humanized" Large Animal Cancer Models: Accelerating Time and Effectiveness of Clinical Trials | Frontiers Research...
As the vast majority of drugs tested in small animal cancer models fail in human clinical trials, there is a need for large ... Utilization of large animal models also allows for testing of the same devices and tools used in human clinical practice in ... animal models to translate results obtained in small animal models to human clinical practice. In addition, the majority of ... futuristic perspectives with respect to the emerging requirements of large animal cancer models to address unmet clinical needs ...
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower - Full Text View - ClinicalTrials.gov
... information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ... Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower. The safety and scientific validity of this ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668668 ... Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity ...
USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 - Study Results - ClinicalTrials.gov
Browsing by Subject "Clinical Trials as Topic"
... laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. ... Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. Khan, MS; Krasuski, Richard ... committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. ... A model for harmonizing flow cytometry in clinical trials. Amos, M; Aranda, R; Banchereau, J; Boshoff, C; Braun, J; Cho, J; ...
topic:"Clinical Trials as Topic" found 1242 records • Arctic Health
Clinical Trials as Topic Colitis, Ulcerative - drug therapy Double-Blind Method Enema Female Humans Male Mesalamine Proctitis ... Clinical Trials as Topic Denmark Humans Netherlands PubMed ID. 22745975 View in PubMed ... Clinical Trials as Topic Crohn Disease - drug therapy Drug Evaluation Humans Metronidazole - therapeutic use Sulfasalazine - ... Clinical Trials as Topic Denmark Femoral Fractures - blood - epidemiology - etiology Great Britain Humans ...
CLL Topics: Rituxan plus Fenretinide Clinical Trial
The R + Fenretinide Clinical Trial. This is a Phase-2 clinical trial, recruiting patients with B-cell cancers (CLL patients as ... I urge you to read it carefully, if you are interested in this clinical trial. Unfortunately, since this clinical trial ... CLL Topics is proud to announce our sponsorship of a brand-new Phase II clinical trial that has just opened for recruitment at ... Dont be shy about it! Volunteering to participate in clinical trials is a big deal and it is very important that you get your ...
Timely topics in statistical methods for clinical trials. | Harvard Catalyst Profiles | Harvard Catalyst
PAR-14-182: Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34)
Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182. NCCIH ... Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) ... The clinical significance and, when applicable, the biological relevance of the future clinical trial must be clearly stated. ... Future Clinical Trial: A concise summary of the subsequent proposed trial should be provided including the study design ( ...
PAR-18-596: Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)
Research on Current Topics in Alzheimers Disease and Its Related Dementias (R01 Clinical Trial Optional) PAR-18-596. NIA ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy ...
Clinical Trials, Phase II as Topic | Profiles RNS
Clinical Trials, Phase II as Topic*Clinical Trials, Phase II as Topic ... "Clinical Trials, Phase II as Topic" by people in this website by year, and whether "Clinical Trials, Phase II as Topic" was a ... "Clinical Trials, Phase II as Topic" is a descriptor in the National Library of Medicines controlled vocabulary thesaurus, MeSH ... Below are the most recent publications written about "Clinical Trials, Phase II as Topic" by people in Profiles. ...
Government Contract Award: NICHD Contraceptive Clinical Trials Network (Female Contraceptive Trials Topic Area)
GSK clinical trial may start this fall for Ebola vaccine | Drug Topics
... is expected to begin a phase 1 trial this fall on a potential vaccine for the treatment of Ebola virus, a deadly disease that ... GSK clinical trial may start this fall for Ebola vaccine. @media screen and (max-width: 468px) { .video-detail .doc-group- ... Cardiovascular Clinical Consult DiabetesGenericsGut HealthImmunizationOncologyRespiratoryShinglesTechnologyThoughtSpot 2020. ... Clinical. AnticoagulantsAutoimmune DiseasesBiosimilarsCardiovascular DiseaseCBDCOPD ManagementCoronavirusDermatologyDiabetes ...
3rd KCE Trials symposium - Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Trial Data...
3rd KCE Trials symposium - Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Trial Data ... 3rd KCE Trials symposium - Hot Topics in Clinical Trials: Developing Research Agendas, New Methods in Trials and Trial Data ... KCE Trials invites you to subscribe to the Symposium: Hot Topics in Clinical Trials: Developing Research Agendas, New Methods ... Status and impact of sharing of clinical trial data. Christian Ohmann, ECRIN, formerly University of Duesseldorf, Clinical ...
clinical trials as topic | Journal for ImmunoTherapy of Cancer
... phase I/II clinical trial Bo Zhang, Jing Huang, Jialin Tang, Sheng Hu, Suxia Luo, Zhiguo Luo, Fuxiang Zhou, Shiyun Tan, Jieer ... Clinical efficacy of T-cell therapy after short-term BRAF-inhibitor priming in patients with checkpoint inhibitor-resistant ... Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer ... Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of breast cancer ...
Topic: Anti-PD-1 Immunotherapy Clinical Trial Update | GRACE :: Global Resource for Advancing Cancer Education
I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the clinicaltrials.gov website. Is ... Update on my anti-PD-1 clinical trial (MK 3475): I had my twelve-week scans this week. Everyone, including the doctors, trial ... Anti-PD-1 Immunotherapy Clinical Trial Update Portal › Forums › Lung/Thoracic Cancer › NSCLC › Stage IV NSCLC › Anti-PD-1 ... There was an earlier discussion of comparable trials here:. http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/ ...
Prescrire IN ENGLISH - Topics - Advancing healthcare policy : Transparent, independent health authorities, Clinical trials...
A summary of clinical trial results is insufficient. The scientific data generated in clinical trials data are a public good. ... Transparent, independent health authorities: The worldwide debate on access to clinical trial data. Clinical trials regulation ... Access to all the data from clinical trials, in the form of clinical study reports, is crucial to ensure the reliability of ... Transparency in the public interest: How the EMA policy on publication and access to clinical-trial data could help save lives ...
Browsing Meeting reports by Subject "Controlled Clinical Trials as Topic"
Clinical Trials | Science News
Clinical Trials | Science News
WHO | Research policy topics
Clinical trials registration. The mission of the WHO International Clinical Trials Registry Platform (ICTRP) is to ensure that ... Research policy topics. Strategy on research for health. WHO is currently working on a Research Strategy. The paper will focus ... IGPH aims to provide information and facilitate the application of genomics-based knowledge and technologies in clinical and ...
Ensuring Accuracy in Clinical Trial Publications: Weighing Options, University of Maryland CERSI | FDA
FDA and University of Maryland CERSI Lecture on Ensuring Accuracy in Clinical Trial Publications: Weighing Options by Peter ... Doshis lecture, he and a colleague have published an editorial on this topic in The BMJ:. PDoshi and FGodlee, The wider role ... particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and ... He is an advocate for greater public access to clinical trial data. Dr. Doshi also has strong interests in journalism as a ...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , Guidance for Industry, Investigators ... Search General and Cross-Cutting Topics Guidance Documents. *Advisory Committee Guidance Documents ... Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice ... FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, ...
A phase I/IIa clinical trial in Duchenne muscular dystrophy using systemically delivered morpholino antisense oligomer to skip...
Topic(s). * HEALTH.2012.1.4-4 - Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach ... We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. ... A phase I/IIa clinical trial in Duchenne muscular dystrophy using systemically delivered morpholino antisense oligomer to skip ... 2 Phase Ib and 2 Phase IIa clinical trials (MDEX Consortium in collaboration with Sarepta Therapeutics; a Dutch Consortium) ...
STANDARDISATION OF HIV NEUTRALISATION ASSAYS TO BE USED IN VACCINE RESEARCH AND CLINICAL TRIALS | NEUTNET Project | FP6 |...
Topic(s). * LSH-2002-2.3.0-2 - HIV microbicides Call for proposal. FP6-2003-LIFESCIHEALTH-3. See other projects for this call ... The results of NeutNet will benefit HIV vaccine research and clinical trials making it possible to compare all vaccine effort s ... STANDARDISATION OF HIV NEUTRALISATION ASSAYS TO BE USED IN VACCINE RESEARCH AND CLINICAL TRIALS. ... aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of ...
Copyright: Public domain / Subjects: Clinical Trials as Topic / Genre: Congresses and Posters / Dates by Range: 1950-1999 -...
EU-funded wearable robots show promising results in clinical trials | Digital Single Market
"Clinical tests showed that hardware and software could be adjusted to the specific characteristics of these subjects providing ... "Clinical tests showed that hardware and software could be adjusted to the specific characteristics of these subjects providing ... Specifically, all subjects who had been mobile before the trial seemed to improve their walking speed and/or balance during ...
2018VaccineHuman clinic2017EfficacyPracticeTreatmentsOutcomesStudiesResearchersEpidemiologyAmerican SocietyPrincipal InvestigatorSearchFrontiers Research TopicExploratory clinicalInterventionsPlacebo-controlledResultsTherapiesParticipantsSystematic reviewBreast cancer clinical trialsInvestigatorsParticipateCentersInstitutional RevieEvidenceStatisticalSharing of clinical trial dataParticipation in clinical trialsLaboratoryBiomedicalHealthcareImmunotherapyEffectivenessDataAccrualConduct Clinical TrialsPerspectivesAccess to clinical trialCancerFindMedicalPediatricStudy2016Phase I triSuccessful clinical trialImportance of clinicalAlzheimer's DiseaseMemorial Sloan Kettering
20182
Vaccine10
- GlaxoSmithKline (GSK) with its partner, the National Institute of Allergy and Infectious Diseases (NIAID), is expected to begin a phase 1 trial this fall on a potential vaccine for the treatment of Ebola virus, a deadly disease that has killed approximately 1,000 in a recent outbreak in West Africa, according to a report by Reuters. (drugtopics.com)
- In preclinical trials in primates, GSK's vaccine has shown promise, according to the NIAID. (drugtopics.com)
- The results of NeutNet will benefit HIV vaccine research and clinical trials making it possible to compare all vaccine effort s throughout Europe and beyond. (europa.eu)
- Data from HIV-1 antibody-negative men (n = 698) enrolled in Project ACHIEVE in New York City were analyzed to assess willingness to participate in efficacy trials, factors influencing willingness, and the effect on willingness of the June 1994 media events about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials. (isharonline.org)
- Focus group discussions were conducted to assess factors that might impact participation of subgroups in Chennai for future HIV vaccine trials. (isharonline.org)
- Participants expressed an intense interest in future HIV vaccine trials. (isharonline.org)
- This entry was posted in Clinical Trials & Studies , Featured Posts , Pharmaceuticals , Science and tagged #covid19 , #diaryofaplagueyear , COVID-19 , Covid-19 vaccine , vaccines . (bioethics.net)
- This is a list of vaccine -related topics . (wikipedia.org)
- Adenovirus Vaccine Efficacy Trial Consortium (2013). (wikipedia.org)
- https://www.europeanpharmaceuticalreview.com/news/117962/mers-vaccine-shows-promise-in-clinical-trial-say-researchers/ https://www.sciencedaily.com/releases/2019/04/190415081956.htm#:~:text=Summary%3A,viruses%20in%20the%20same%20family.&text=Nipah%20virus%20is%20a%20type,transmitted%20from%20animals%20to%20humans. (wikipedia.org)
Human clinic4
- As the vast majority of drugs tested in small animal cancer models fail in human clinical trials, there is a need for large animal models to translate results obtained in small animal models to human clinical practice. (frontiersin.org)
- This Research Topic will also address training needs with regards to comparative pathology and the development of imaging standards to support relevant interpretation of findings and expedite the launch of human clinical trials. (frontiersin.org)
- NeutNet, a group of 13 participants from all over the world, proposes to co-ordinate activities aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines. (europa.eu)
- ROCKVILLE, MD - A drug and drug delivery candidate technology, research into which has been funded by the National Foundation for Cancer Research (NFCR), has recently been approved by the U.S. Food and Drug Administration (FDA) for the initiation of human clinical trials. (nfcr.org)
20172
- April 12, 2017 - Notice of Informational Webinars for Investigators Applying for NCCIH Clinical Trials. (nih.gov)
- Findings from the DEFINE FLAIR and iFR Swedeheart trials, which studied 4,529 patients as part of the largest randomized coronary physiology outcome studies to date, were presented at the 2017 American College of Cardiology's Annual Scientific Session & Expo (ACC.17) in Washington, D.C., March 17-19, 2017. (philips.com)
Efficacy16
- The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy. (clinicaltrials.gov)
- This trial may well be that goldilocks scenario we have been looking for, a way of improving the efficacy of Rituxan without increasing toxicity. (clltopics.org)
- This funding opportunity is intended to support exploratory clinical trials, which will provide data that are critical for the planning and design of a subsequent controlled cohort study, clinical efficacy or effectiveness study, or a pragmatic trial. (nih.gov)
- This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy or effectiveness. (nih.gov)
- Access to all the data from clinical trials, in the form of clinical study reports, is crucial to ensure the reliability of pharmaceutical safety and efficacy data and to respect patients who participate in clinical trials. (prescrire.org)
- A recent study published in BMJ open has shown that clinical study reports are comprehensive documents of on average 1 800 pages, containing the following sections: report synopses (about 5 pages), efficacy evaluation (about 13 pages), safety evaluation (17 pages), trial protocol (about 60 pages), and the remaining pages are attached tables and anonymised individual efficacy and safety listings (8). (prescrire.org)
- In numerous cases, data from unpublished and misreported trials has vastly changed our understanding of the safety and efficacy of specific drugs. (fda.gov)
- These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance. (goodreads.com)
- This designation prescribes an accelerated development pathway for FDA approval that determines efficacy based on two different validated animal studies followed by clinical evaluation in phase I and phase II trials to establish safety and immunogenicity for use in humans. (marketwatch.com)
- However, improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed over background medication, suggesting that elevated TLR3 gene signatures previously observed in UC patients, as well as in PULSE, are downstream or circumstantial effects that do not contribute significantly to causal pathology. (marketwatch.com)
- The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (See Food and Drug Administration). (lymphedemapeople.com)
- Efficacy trials of candidate HIV-1 vaccines require study populations at high risk of infection who adhere to study protocols and who are willing to participate. (isharonline.org)
- In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. (isharonline.org)
- Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g. (bioportfolio.com)
- citation needed] Carrageenan preparations (such as 0.5% PRO 2000 and 3% Carraguard vaginal microbicide gels) have failed to demonstrate efficacy in preventing HIV transmission in phase III clinical multicenter trials. (wikipedia.org)
- Similarly, the phase III efficacy trial of Carraguard showed that the drug was safe for use but ineffective in preventing HIV transmission in women. (wikipedia.org)
Practice9
- Utilization of large animal models also allows for testing of the same devices and tools used in human clinical practice in species with similar size, anatomy, physiology, metabolism, immunology, and genetics compared to humans. (frontiersin.org)
- IGPH aims to provide information and facilitate the application of genomics-based knowledge and technologies in clinical and public health practice. (who.int)
- When the completeness or accuracy of the medical literature - particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and systematic reviews. (fda.gov)
- The affirmative decision of the IRB that the clinical trial has been reviewed (i.e. protocol, informed consent(s), conflict of interests, etc.) and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. (lymphedemapeople.com)
- Together the results of these studies demonstrate large simple trials in clinical practice can be done, and should remove any barriers to the use of coronary physiology in interventional procedures. (philips.com)
- He is a Director of the Scientific Archivists Group, Co-Lead for the SAG GCP Special Interest Group, and former Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. (smi-online.co.uk)
- We provide a suggested set of items for inclusion in clinical trial data sets that also are useful in clinical practice. (aacrjournals.org)
- This FOA encourages and provides a mechanism for the submission of applications for multi-center exploratory and confirmatory clinical trials focused on promising interventions, including pragmatic trials performed in large numbers of patients with minimal alteration from clinical practice and low per-patient costs. (sbir.gov)
- Micafungin Safety in Pediatric Patients in Clinical Practice. (choc.org)
Treatments21
- BACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. (duke.edu)
- New medical treatments and devices are being tested in vitro - in a test system, and/or in vivo - clinical trials in living organisms. (europa.eu)
- From studies of the intricate workings of molecules within cells to the results of large-scale clinical trials of treatments, every result helps to deepen our understanding of cancer and find new ways to fight it. (cancerresearchuk.org)
- Clinical trials are vital for improving cancer treatments and making them available to patients. (cancerresearchuk.org)
- The need for randomised trials to establish that treatments are effective is well established. (bmj.com)
- The protocol says what kind of trial it will be, what it will study, who should be in the study, what treatments will be used, and how results will be measured. (kidshealth.org)
- A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. (lymphedemapeople.com)
- Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. (lymphedemapeople.com)
- Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. (lymphedemapeople.com)
- A clinical trial is a study using people who agree to participate in new tests or treatments. (medlineplus.gov)
- Current cancer medicines, tests, and treatments used by most health care providers have been tested through clinical trials. (medlineplus.gov)
- Participating in a clinical trial may give you access to treatments that are not widely available elsewhere. (mskcc.org)
- Clinical trials are important because they compare new treatments with accepted treatments. (rexhealth.com)
- Clinical trials are also important in finding treatments if no standard treatment exists. (rexhealth.com)
- Although the purpose of trials is to find new and better treatments, the new treatment may not work as well as standard treatments. (rexhealth.com)
- You'll want to know what exactly is involved, including potential risks, what treatments you might get, how long the trial will last, how often you'll need appointments, what your other responsibilities might be, and what happens after the trial ends. (webmd.com)
- By doing clinical trials during this pandemic, we are trying to find treatments and, thereby, hope. (gopusa.com)
- However in 1995, Jack was diagnosed with Multiple Myeloma, which started him on a series of numerous treatments, including lots of chemotherapy, 3 stem cell transplants (2 auto's, 1 full allo), 4 rounds of radiation and 2 clinical trials. (smore.com)
- Patients who participate in clinical trials receive the most effective therapy currently available for their condition -- or they may receive treatments that are being evaluated for future use. (webmd.com)
- The CF Foundation offers a number of resources for learning about clinical trials and treatments that are being developed to improve the treatment of cystic fibrosis. (cff.org)
- Clinical trials represent the first essential step toward the development of treatments targeting cancer and various diseases [ 1 , 2 ], and allow researchers to Test the effectiveness of preventive measures, treatments, screenings, and diagnostic techniques [ 3 ]. (intechopen.com)
Outcomes13
- Conflicts of Interest and Outcomes of Cardiovascular Trials. (duke.edu)
- Objective To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes. (bmj.com)
- Outcomes in most trials were subjective-for example, qualitative assessment of the patient's function. (bmj.com)
- 1 One challenge to the validity of such trials is the tendency for assessments of outcomes to systematically deviate from the truth because of predispositions in observers, such as from hope or expectation. (bmj.com)
- Amsterdam, the Netherlands and Washington, D.C. - Royal Philips (NYSE: PHG, AEX: PHIA) today announced that the results from two large clinical trials comparing patient outcomes using instant wave-free ratio (iFR) and fractional flow reserve (FFR) in the diagnosis and treatment of heart disease have been published in the New England Journal of Medicine. (philips.com)
- Despite the critical relevance of smoking to cancer outcomes, most oncology clinical trials do not collect data on smoking history and status unless the malignancy is widely acknowledged as smoking related (e.g., lung or head and neck cancer). (aacrjournals.org)
- Changes in smoking status during treatment or follow-up are monitored in very few trials and are infrequently reported in sample descriptions or included in analysis plans as a potential moderator of outcomes. (aacrjournals.org)
- Based on mounting evidence that tobacco use affects cancer treatment outcomes and survival, we recommend that smoking history and status be systematically collected as core data in all oncology clinical trials: at diagnosis, at trial registration, and throughout treatment and follow-up to long-term survival or death. (aacrjournals.org)
- We feel that the inclusion and analysis of such data in clinical trials will add important information to the interpretation of outcomes and the development of scientific knowledge in this area. (aacrjournals.org)
- Also eligible are biomarker- and outcomes-validation studies that are immediately preparatory to trials in stroke prevention, treatment, or recovery. (sbir.gov)
- Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. (greenmedinfo.com)
- Objectives: The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. (intechopen.com)
- Discussions about clinical trial participation are quite challenging due to the uncertainty regarding the outcomes of clinical trials, and the complex nature of consent documents [ 12 ]. (intechopen.com)
Studies29
- I. Clinical caries studies]. (arctichealth.org)
- Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. (umassmed.edu)
- This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and irinotecan hydrochloride in treating younger patients with solid tumors that have come back or that have not responded to standard therapy. (cincinnatichildrens.org)
- PURPOSE: This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). (cincinnatichildrens.org)
- PURPOSE: This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). (cincinnatichildrens.org)
- Eligibility criteria for selecting studies Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. (bmj.com)
- We extend Lilford and others' proposal that a bayesian statistical approach, using related information from earlier studies, would be useful in designing and subsequently summarising small randomised controlled trials. (bmj.com)
- can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. (marketwatch.com)
- You also can find information online at ClinicalTrials.gov and search for current and upcoming clinical studies around the world. (kidshealth.org)
- In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomization). (lymphedemapeople.com)
- Findings from these two major clinical outcome studies have the potential to significantly improve the use of coronary physiological assessment," said Dr. Manesh Patel, MD, FACC, FSCAI, Chief of the Division of Cardiology and Co-Director of the Duke Heart Center at Duke University School of Medicine. (philips.com)
- Therefore, this Research Topic aims to bring the most recent discovery on the Sirt1 mechanisms involved in vascular protection, novel pharmacological molecules that target Sirt1 for the treatment of the atherosclerosis, and animal and clinical studies related to the effects of Sirt1 against atherosclerosis. (frontiersin.org)
- The intention of this Research Topic is to receive manuscripts from bench to clinical studies of interventions associated with changes in Sirt1 levels and their pathophysiological importance in the atherosclerosis process. (frontiersin.org)
- The network also relies on a statistical and clinical coordinating center to monitor trials and coordinate data from its studies. (nih.gov)
- Clinical trials are research studies in which people help doctors find ways to improve health care. (rexhealth.com)
- Recent studies of the treatment of obesity by moderate and severe caloric restriction show that patients treated in randomized trials using a conventional 1200 kcal/d reducing diet, combined with behavior modification, lose approximately 8.5 kg in 20 weeks. (annals.org)
- This entry was posted in Clinical Trials & Studies , Ethics , Featured Posts , Public Health , Research Ethics , Uncategorized and tagged #diaryofaplagueyear , COVID-19 , policy . (bioethics.net)
- This entry was posted in Clinical Trials & Studies , Conflict of Interest , Decision making , Featured Posts , Health Regulation & Law , Informed Consent , Social Justice and tagged #covid19 , #diaryofaplagueyear , COVID-19 . (bioethics.net)
- Others may consider use of PAR-17-274 , NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery and Prevention (U01). (sbir.gov)
- For this funding opportunity announcement, Phase I and II clinical studies or trials refer to the common phases of a clinical trial. (sbir.gov)
- In addition, the network will support studies to validate biomarkers with demonstrated promise to inform Phase 2 clinical trials. (sbir.gov)
- Primary and secondary prevention stroke trials - studies of agents, devices, or strategies to prevent recurrent stroke in survivors of stroke or transient ischemic attack (TIA), or to prevent first stroke in high-risk populations. (sbir.gov)
- The studies may range from concept to developmental phases, with a clear commercialization plan to enable healthcare providers to use them in regular clinical care settings in the population, which is the focus of this FOA. (sbir.gov)
- We understand that problems of patient recruitment and retention exist in all facets of clinical research, especially in studies on acute otitis media. (jaoa.org)
- Search for clinical trials, research studies and investigators by research topic. (sutterhealth.org)
- As far as regulatory bodies are concerned, the best evidence comes from well-controlled human clinical studies 1 , although this is not the only kind of acceptable evidence. (mastercontrol.com)
- Moreover, consistent data formatting across studies (e.g. across two or more phase 2 trials) sometimes appears to slow the process of trial completion. (cytel.com)
- However, despite the evidence for the positive benefits of conducting clinical trials, and despite the overall agreement on the importance of clinical research (as evidenced by the Cancer Moonshot initiative and recent, highly funded efforts directed toward advancing precision medicine), researchers are limited by the low number of patients consenting to join clinical research studies [ 4 , 5 ]. (intechopen.com)
- Conversations with patients and their families intended to educate them about participation in clinical trials and research studies present unique challenges that differ significantly from typical exchanges in the provider‐patient encounter. (intechopen.com)
Researchers13
- With their unique mixes of varied contributions from Original Research to Review Articles, Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! (frontiersin.org)
- As researchers, doctors, scientists, patients and civil society representatives we are asking you to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed. (prescrire.org)
- The disclosure of a summary of results, as suggested by the European Commission, is of little scientific value, as it does not supply healthcare professionals and independent researchers with the information they need to judge the merit of a trial or to be able to use its results to support rational prescribing. (prescrire.org)
- Establishing clinical study reports (CSR) or a full dataset as a disclosure format does not represent an added burden for academics or non---commercial researchers. (prescrire.org)
- Published clinical study results are increasingly published together with the full dataset of individual anonymised patients data: the researchers often simply upload the files containing their full dataset to the website of the publisher (9,10). (prescrire.org)
- A clinical trial is a study that researchers do to see whether a treatment (such as a new medicine, therapy, or surgery) works well and is safe. (kidshealth.org)
- In a randomized, controlled clinical trial, researchers often are trying to find out if a treatment works. (kidshealth.org)
- Therefore, the proposed Research Topic on Sirt1 may be of great interest to researchers in the field of chronic degenerative diseases and also of great impact to the section of "Cardiovascular and Smooth Muscle Pharmacology" of the journal Frontiers in Pharmacology . (frontiersin.org)
- Clinical trials help researchers know whether a new treatment works well and is safe. (medlineplus.gov)
- A phase II trial includes more people as the researchers look at safety and how well the treatment works. (webmd.com)
- Doctors, nurses, and researchers follow your health very closely during a clinical trial, says Sarat Chandarlapaty, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York. (webmd.com)
- Through clinical trials , researchers test the effects of new medications on a group of volunteers with brain cancer. (webmd.com)
- In May this year we asked patients, volunteers and researchers who have taken part in or helped to run clinical trials to tell us what questions and comments they have to keep people involved. (peopleinresearch.org)
Epidemiology1
- 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. (nih.gov)
American Society1
- American Society of Clinical Oncology educational book. (duke.edu)
Principal Investigator2
- Most often, the CCC is headed by the Clinical Principal Investigator and is responsible for protocol development, clinical sites, and oversight of clinical study operations and facilities. (lymphedemapeople.com)
- He is the principal investigator on several clinical trials. (smore.com)
Search3
- You can search for trials near you or those looking for people like you. (webmd.com)
- When experiments travel : clinical trials and the global search for human subjects / Adriana Petryna. (who.int)
- This website, developed by the nonprofit Coalition of Cancer Cooperative Groups, is an unbiased cancer clinical trial matching and navigation service enabling patients to search for cancer trials based on disease and location. (webmd.com)
Frontiers Research Topic1
- Find out more on how to host your own Frontiers Research Topic or contribute to one as an author. (frontiersin.org)
Exploratory clinical1
- Exploratory clinical trials must include a clearly defined go/no-go pathway toward advancement to a future Phase 3 trial. (sbir.gov)
Interventions1
- The randomised clinical trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. (bmj.com)
Placebo-controlled4
- The Phase 1b PULSE (Provention ULcerative colitis Safety/PK/PD Evaluation) clinical trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study that evaluated PRV-300 in 28 active, and 9 placebo, adult patients with moderate-to-severe ulcerative colitis. (marketwatch.com)
- A placebo controlled randomized clinical trial of Crocus sativus L. (greenmedinfo.com)
- A placebo controlled randomized clinical trial of Crocus sativus L. (saffron) on depression and food craving among overweight women with mild to moderate depression. (greenmedinfo.com)
- Seventy-three women with BMI ≥ 25 comorbid with mild-to-moderate depression were recruited in this 12-week double-blind, placebo-controlled randomized clinical trial. (greenmedinfo.com)
Results15
- Compliance with results reporting at ClinicalTrials.gov. (duke.edu)
- BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. (duke.edu)
- Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials. (duke.edu)
- Everyone, including the doctors, trial nurses, and my family and friends, was very anxious to see the results, as I am the first of the lung cancer arm to get my scans at my clinic. (cancergrace.org)
- OLDWICK, N.J., May 8, 2019 /PRNewswire/ -- Provention Bio, Inc. PRVB, -4.93% a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced preliminary top-line results from its Phase 1b PULSE study which evaluated PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody, in patients with active, moderate-to-severe ulcerative colitis (UC). (marketwatch.com)
- Will we be told about the trial results? (kidshealth.org)
- Preliminary results from one of the earliest clinical trials of CRISPR-Cas9 provide evidence that the technique is safe and feasible to use for treating human diseases. (bioportfolio.com)
- After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. (rexhealth.com)
- If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public. (rexhealth.com)
- Phase 1 trial is they don't know what the results are going to be. (healthtalk.org)
- Opt-e-scrip claims accuracy is improved by comparing new test results against its database of results from previous single-patient clinical trials. (technologyreview.com)
- Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results? (cytel.com)
- Results from Genmab's HuMax-CD20 Phase II Clinical Trial ) responding to his latest round of therapy with HuMax-CD20. (clltopics.net)
- PRO 2000 was demonstrated to be safe, but it did not reduce the risk of HIV infection in women (as explained in the MDP 301 trial results, released in December 2009). (wikipedia.org)
- On February 1, 2007, the International AIDS Society announced that two phase III trials of cellulose sulfate had been stopped because preliminary results suggested a potential increased risk of HIV in women who used the compound. (wikipedia.org)
Therapies2
- With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. (marketwatch.com)
- The network is designed to increase the efficiency of stroke clinical trials by facilitating patient recruitment and retention, supporting novel methodologies and streamlined approaches to accelerate the development of promising stroke therapies, and enabling comparison between approaches. (sbir.gov)
Participants4
- This is a waste of research money and an abuse of clinical trial participants' altruism and trust (1 to 5). (prescrire.org)
- In a randomized clinical trial, participants are assigned by chance to different treatment groups. (britannica.com)
- The company sponsoring the trial will have a very strict set of standards, or criteria, that all participants must meet. (rexhealth.com)
- What are the most important questions about how to encourage trial participants to stay involved? (peopleinresearch.org)
Systematic review1
- Design Systematic review of trials with both blinded and non-blinded assessment of the same binary outcome. (bmj.com)
Breast cancer clinical trials1
- Effect of socioeconomic status as measured by education level on survival in breast cancer clinical trials. (duke.edu)
Investigators3
- I would like to thank the PULSE study patients, coordinators and investigators, as well as Provention's expert clinical development team, for their time, efforts, and dedication in conducting such a definitive, cost-effective, and efficient clinical trial,' said Ashleigh Palmer, CEO of Provention Bio. (marketwatch.com)
- Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients. (isharonline.org)
- A randomized clinical trail led by Huntsman Cancer Institute investigators finds that a combinatorial chemotherapy reduces precancerous polyps by 75 percent in patients at high-risk for cancer. (utah.edu)
Participate5
- Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. (isharonline.org)
- A clinical trial will recruit many people to participate. (medlineplus.gov)
- One of the many benefits we can offer you is the chance to participate in clinical trials. (mskcc.org)
- We not only start clinical trials to improve the detection and treatment of thyroid cancer but also participate in most major thyroid cancer clinical trials taking place around the country. (mskcc.org)
- You should be fully informed about the possible risks of the trial before you agree to participate. (rexhealth.com)
Centers5
- Most trials take place at academic medical centers, often in cities. (webmd.com)
- The NIH StrokeNet comprises a National Clinical Coordinating Center (NCC), a National Data Management Center (NDMC) and 25 geographically distributed Regional Coordinating Centers (RCC) with over 350 affiliated stroke centers. (sbir.gov)
- Some of the best CLL expert centers are participating in this trial. (clltopics.net)
- Even with the large number of centers participating in this trial, this would mean a significant amount of travel to and from the trial center for most of us and you should be prepared for that. (clltopics.net)
- Many physicians characterize discussions about research and clinical trials with patients as particularly challenging, a problem, which is rarely addressed, even by academic medical centers committed to the research enterprise [ 9 ]. (intechopen.com)
Institutional Revie1
- Continuing review of the clinical trial conducted annually by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. (lymphedemapeople.com)
Evidence4
- 1 We suggest a scoring system for pooling this evidence and detail how this may be combined with hypothetical scenarios to assist in the design of, and justification for, a small randomised controlled trial. (bmj.com)
- Once a clinical study is completed, the clinical study records are the primary - and often the only - evidence of clinical study activities, which are critical to permitting evaluation of the conduct of the study and the quality of the data produced. (smi-online.co.uk)
- Serving over 2,000 healthcare organizations, Elsevier's clinical and technology experts are at the forefront of helping their customers leverage evidence-based content in the EMR and at the point of care. (elsevier.com)
- When implementing a trial, try if you can to leave a clear audit trail of who had access to what evidence at which point in the trial. (cytel.com)
Statistical3
- Timely topics in statistical methods for clinical trials. (harvard.edu)
- To ask other readers questions about Key Statistical Concepts in Clinical Trials for Pharma , please sign up . (goodreads.com)
- An overview of commonly used statistical methods in clinical research. (childrensmercy.org)
Sharing of clinical trial data1
- Bumps and bridges on the road to responsible sharing of clinical trial data. (duke.edu)
Participation in clinical trials1
- The Alliance works with partner organizations and government agencies such as FDA and NIH to increase older adult participation in clinical trials, including for diseases such as Alzheimer's disease. (agingresearch.org)
Laboratory2
- Clinical and Laboratory Features of Pertussis During a California Epidemic. (choc.org)
- citation needed] Consequently, laboratory and clinical trials testing this class of products as microbicides have largely been discontinued. (wikipedia.org)
Biomedical1
- The primary users of in silico clinical trials technologies will be the biomedical industries", explains Dr. McCormack. (europa.eu)
Healthcare5
- Advancing healthcare policy : Transparent, independent health authorities, Clinical trials regulation: choose transparency! (prescrire.org)
- FDA scientists have unique insights into this problem and unique abilities to do something about it, in doing so both improving clinical care and promoting more prudent use of healthcare resources. (fda.gov)
- This will reduce the costs and the risks (both clinical and financial) involved in trials, and it will ultimately increase the rate of innovation in healthcare. (europa.eu)
- A South Dakota rural healthcare provider will launch a clinical trial of anti-malarial drug hydroxychloroquine to see if it can cure or treat COVID-19, Republican Gov. Kristi Noem announced Monday. (gopusa.com)
- The biotech medicine is the first plant-produced antibody to be greenlit for clinical testing by Britain's Medicines and Healthcare products Agency . (zdnet.com)
Immunotherapy2
- Inovio Pharmaceuticals, Inc. INO, +2.06% announced today that the company has initiated a phase I trial to evaluate safety, tolerability and immune responses of Inovio's DNA immunotherapy for Ebola. (marketwatch.com)
- This initial trial will evaluate Inovio's Ebola immunotherapy (INO-4212) in five groups of healthy subjects receiving INO-4212 and its components (INO-4201 and INO-4202) alone or in combination with INO-9012, delivered into muscle or skin using Inovio's proprietary DNA delivery technology. (marketwatch.com)
Effectiveness1
- Clinical trials compare the effectiveness of this medicine or treatment against standard, accepted treatment or against a placebo if there is no standard treatment. (rexhealth.com)
Data16
- Complexities in sample handling, instrument setup and data analysis are barriers to the effective use of flow cytometry to monitor immunological parameters in clinical trials. (duke.edu)
- Access to patient-level data from GlaxoSmithKline clinical trials. (duke.edu)
- The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. (duke.edu)
- The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial. (nih.gov)
- Numerous recent drug disasters would have been avoided if public access to clinical data had been granted. (prescrire.org)
- The scientific data generated in clinical trials data are a public good. (prescrire.org)
- He is an advocate for greater public access to clinical trial data. (fda.gov)
- eight trials provided individual patient data. (bmj.com)
- Blinded and non-blinded assessors agreed in a median of 78% of assessments (interquartile range 64-90%) in the 12 trials with available data. (bmj.com)
- Person who handles the administrative and day-to-day responsibilities of a clinical trial, acts as liaison for the clinical site, and reviews all data and records before a monitor's visit. (lymphedemapeople.com)
- 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. (nih.gov)
- Usually, these data are collected only at trial registration. (aacrjournals.org)
- Síle Lane from Sense About Science discusses the recent European Court injunction on clinical trial data. (plos.org)
- Management of data in clinical trials / Eleanor McFadden. (who.int)
- For example, clinical-trial data from Schering-Plough indicated that patients taking its allergy drug Claritin showed a 46-percent improvement in symptoms. (technologyreview.com)
- Reproducibility is a rarely discussed, but absolutely critical aspect of trial implementation and data management. (cytel.com)
Accrual2
- hence reducing the accrual time for launching a human clinical trial. (frontiersin.org)
- Research on the reasons for clinical trials' low accrual rates has identified several key barriers, which include a low rate of physicians' referral [ 7 , 8 ]. (intechopen.com)
Conduct Clinical Trials2
- How to Conduct Clinical Trials in Children: A Tutorial. (childrensmercy.org)
- CCTN was established in 1996 to support research on male and female contraception and to conduct clinical trials of new contraceptive drugs and devices. (nih.gov)
Perspectives1
- This Frontiers in Oncology Research Topic provides futuristic perspectives with respect to the emerging requirements of large animal cancer models to address unmet clinical needs. (frontiersin.org)
Access to clinical trial1
- Ginny Barbour, Medicine Editorial Director at PLOS, discusses a recently-published UK Government spending report on access to clinical trial information and the stockpiling of Tamiflu. (plos.org)
Cancer24
- Randomised controlled trials are regarded as the standard when comparing a new treatment with the standard treatment for a particular cancer. (bmj.com)
- If you have cancer, a clinical trial may be an option for you. (medlineplus.gov)
- Trials are available for many cancers and all stages of cancer, not just advanced cancer. (medlineplus.gov)
- What is a Clinical Trial for Cancer? (medlineplus.gov)
- You can find clinical trials listed on the website of the National Cancer Institute (NCI) -- www.cancer.gov/about-cancer/treatment/clinical-trials . (medlineplus.gov)
- Ask if there is a trial in your area related to your cancer. (medlineplus.gov)
- If participating in a thyroid cancer clinical trial is a good option for you, we can help you find the research study that best fits your needs. (mskcc.org)
- Learn about thyroid cancer clinical trials enrolling patients now. (mskcc.org)
- Scientists look for new ways to treat advanced breast cancer in clinical trials. (webmd.com)
- Through a clinical trial, a patient may get access to a new medicine that could potentially be the next great drug," says Erica L. Mayer, MD, MPH, of the Dana-Farber Cancer Institute in Boston. (webmd.com)
- Community cancer clinics near you may be part of a large trial. (webmd.com)
- Clinical trials are an extremely important in finding new ways to treat cancer and help patients live well with their diagnosis. (cancersupportcommunity.org)
- On this episode of Frankly Speaking Cancer, host Kim Thiboldeaux is joined by four guests with four different clinical trial experiences who will each share their stories of how participating in a clinical trial gave them each hope. (cancersupportcommunity.org)
- Some patients are reluctant to take part in clinical trials for fear of getting no treatment at all for their brain cancer. (webmd.com)
- This website lists more than 12,000 cancer clinical trials, describes the trials, gives eligibility criteria, and explains what to do when you find one that you think is right for you. (webmd.com)
- This website offers up-to-date information for locating federally and privately supported clinical trials for cancer in the U.S. and around the world. (webmd.com)
- Sutter Health patient Bob Murphy describes how a clinical trial helped change his life while battling lung cancer. (sutterhealth.org)
- Sutter Health patient Laura Clausen describes how research and clinical trials at Sutter gave new hope in her cancer journey. (sutterhealth.org)
- Patient Grace Mansell describes how clinical research and clinical trials at Sutter are helping advance treatment options for cancer patients. (sutterhealth.org)
- Medical clinical trials are about more than just testing medications, they provide valuable research that can lead to better treatment methods for beating cancer. (utah.edu)
- This topic will tell you about the early testing, diagnosis, and treatment of colorectal cancer. (adventisthealthcare.com)
- If you want to learn about colorectal cancer that has come back or has spread, see the topic Colorectal Cancer, Metastatic or Recurrent . (adventisthealthcare.com)
- If you want to learn about anal cancer, see the topic Anal Cancer . (adventisthealthcare.com)
- Therefore, the clinical use of fenretinide as a cancer therapeutic by itself is limited-that is, unless delivered to cancer cells in a manner via which the molecule's insolubility will no longer be problematic. (nfcr.org)
Find11
- Please find clinical trials at HSS listed by the following topics or view the full directory . (hss.edu)
- I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the clinicaltrials.gov website. (cancergrace.org)
- Find out more about our research by topic below. (cancerresearchuk.org)
- Find out more about some of the clinical trials we support. (cancerresearchuk.org)
- Learn about why you might want to enroll in a clinical trial and where to find one. (medlineplus.gov)
- How to Find a Clinical Trial? (medlineplus.gov)
- The purpose of a clinical trial is to find out whether a medicine or treatment is safe and effective for treating a certain condition or disease. (rexhealth.com)
- Your doctor will help you find out if you are eligible to take part in a clinical trial. (rexhealth.com)
- The only way to find out which treatment is best is by comparing them head-to-head in a clinical trial. (webmd.com)
- The following websites offer information and services to help you find a clinical trial that is right for you. (webmd.com)
- For all the science behind today's drugs, it's often a trial-and-error process to find the ones that work best for you . (technologyreview.com)
Medical9
- Non-orthopedic and non-rheumatologic clinical trials are conducted at Weill Cornell Medical College , an affiliate of Hospital for Special Surgery. (hss.edu)
- Clinical Trials, Phase II as Topic" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus, MeSH (Medical Subject Headings) . (umassmed.edu)
- Clinical Trials as Topic" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus, MeSH (Medical Subject Headings) . (childrensmercy.org)
- A medical researcher in charge of carrying out a clinical trial's protocol. (lymphedemapeople.com)
- Clinical trials play a significant role in medical research and, without them, innovative discoveries and breakthroughs wouldn't make it to the patients who need them. (agingresearch.org)
- In a news item reported in Rolling Stone , NPR , and The Houston Chronicle , the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own "observational" trials-minus a control group, minus informed consent, minus informing anyone. (bioethics.net)
- We started adjusting it based on the needs of the medical community for acknowledgment, for having a clinical as well as a plain English page. (zdnet.com)
- Phase I clinical trials for its safety are expected to begin later this year at the Rush University Medical Center in Chicago. (nfcr.org)
- All collapsed athletes admitted to the medical facilities were considered for the trial. (bmj.com)
Pediatric4
- Economic return of clinical trials performed under the pediatric exclusivity program. (duke.edu)
- PURPOSE: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit, and the ethical concerns of pediatric hematologists and oncologists in the United Kingdom and North America. (isharonline.org)
- A major objective of this funding opportunity announcement (FOA) is to invite SBIR applications to foster collaboration between clinical and bioengineering research communities to develop and test safe, accurate, and effective devices for use in neonatal, perinatal, and pediatric care settings. (sbir.gov)
- Dedicated to clinical excellence, Dr Arrieta is board certified in pediatrics and pediatric infectious diseases. (choc.org)
Study11
- Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study. (duke.edu)
- Moreover, the European Ombudsman's ruling is that clinical study reports contain no "commercially confidential" information (2,7). (prescrire.org)
- Since 2009, Dr. Doshi has worked with a team that sifted through FDA approval packages and formerly confidential clinical study reports of the anti-influenza drugs oseltamivir and zanamivir. (fda.gov)
- The type of study used for most clinical trials is called a randomized, controlled clinical trial . (kidshealth.org)
- Who can be part of a clinical trial depends on the study. (kidshealth.org)
- In a multi-site study, the coordinator at the CCC oversees the clinical research coordinators at the clinical sites and is called the Project Coordinator. (lymphedemapeople.com)
- Clinical trials are also monitored during the entire study. (medlineplus.gov)
- Before you join a clinical trial, you will learn about the safety guidelines, what is expected of you, and how long the study will last. (medlineplus.gov)
- Each clinical study has guidelines about who can join. (medlineplus.gov)
- well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections. (smi-online.co.uk)
- For example, a treatment recommendation that involves the possibility of enrolling in a clinical trial is fraught with uncertainty because patients are generally randomized into one of multiple treatment arms, and because the treatment itself is under study [ 13 ]. (intechopen.com)
20162
- SMi's Clinical Trial Documentation masterclass returns to London in 2016! (smi-online.co.uk)
- SMi is proud to announce the return of the 2nd annual Clinical Trial Documentation Management masterclass in 2016! (smi-online.co.uk)
Phase I tri1
- The phase I trial, carried out at the University of Surrey Clinical Research Centre , will test the safety of the plant-produced antibody designed to stop transmission of HIV when applied directly to the vaginal cavity. (zdnet.com)
Successful clinical trial2
- Becoming a successful clinical trial investigator : a step by step guide for developing a clinical trial site / P.K. Julka. (who.int)
- Even with a successful clinical trial, there are still limitations on what advertising can say or imply. (mastercontrol.com)
Importance of clinical1
- Dr. Ajai Chari will be discussing the importance of clinical trials and why people should enrol in them. (smore.com)
Alzheimer's Disease1
- The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing research on current topics in Alzheimer's disease and its related dementias. (nih.gov)
Memorial Sloan Kettering1
- Memorial Sloan Kettering doctors are constantly working to improve treatment for people with soft tissue sarcoma through clinical trials. (mskcc.org)