... on a case-by-case basis. Guidance specific methodology for determining number and location of field trials. ... 12 Minimum Number of Field Trials ...
EPA Pesticide Factsheets
Phase I, II, III, and IV trials for cancer and other life-threatening conditions, with coverage for Phase I and II trials to be decided on a case-by-case basis.
Cancer.gov
The NSABP-32 trial is a randomized, phase III clinical trial to compare sentinel node (SN) resection to conventional axillary dissection in clinically node-negative breast cancer patients. The primary aims of the trial are to determine if removal of only SNs provides survival and regional control equivalent to ...
PubMed
First randomized clinical trials have demonstrated that stem cell therapy can improve cardiac recovery after the acute phase of myocardial ischemia and in patients with chronic ischemic heart disease. Nevertheless, some trials have shown that conflicting results and uncertainties remain in the case of mechanisms of action and possible ...
PubMed Central
The Cancer Imaging Program is sponsoring limited Phase I/II trials for new imaging agents and methods.
Failure-Free Survival in SWOG 9133 Overall Survival of Patients Treated on SWOG 9133 High rate of missing data at 1 and 2 years with few deaths or relapses.
An advisory committee to the U.S. Food and Drug Administration (FDA) last week recommended against the approval of two drugs for the treatment of advanced melanoma and brain metastases, respectively. In both cases, the drugs' manufacturers had submitted applications for FDA approval of their products based on the results of a single phase III clinical ...
Following the Allman and the Zlotsky and Ballard classifications, 85 cases of acromioclavicular disruptions (ACD) have been treated. Types I and II have been conservatively managed, while type III was treated by a special surgical technique described in the text. Types I and II were reviewed by a questionnaire form and type III was ...
The results of previous clinical trials, in a variety of clinical settings, showed that class I agents may consistently increase mortality in sharp contrast to the effects of beta blockers. Attention has therefore shifted to class III compounds for potential beneficial effects on long-term mortality among patients with underlying cardiac disease. Clinical ...
... Title : Phase I/II Trial of Epothilone Analog BMS-247550, Mitoxantrone, and Prednisone in HRPC Patients Previously Treated with Chemotherapy. ...
DTIC Science & Technology
Phase I, II, III, and IV cancer treatment, supportive care, early detection, and prevention trials. Phase II, III, and IV trials for other life-threatening conditions.
Carbon ion radiotherapy (CIRT) is a promising modality because of its excellent dose localization and high biological effect on the tumor. Our clinical trials led us to conclude that irradiation with heavy particle beams, notably carbon ion beams, offers a significant potential for improving tumor control without increasing toxicity risks. In lung cancer treatment, between ...
Introduction: Paclitaxel, Carboplatin, and Bevacizumab (PCB) is one of the standard chemotherapy regimens for the treatment of non-small cell lung cancer. Temporary asymptomatic bradycardia is recognized toxicity of paclitaxel. However, it is under-disclosed to patients during consent for treatment and is under-reported in clinical phase III trials. ...
BACKGROUND: The literature on the design, conduct, and analysis of non-inferiority trials is continuously evolving. Several design issues continue to be researched including the choice of active control, choice of non-inferiority margin, and optimal analytic approaches. To date, there has been relatively little in the literature documenting actual experiences with implementing ...
Immunotherapy is showing promise for the treatment of a range of tumours including prostate cancer, melanoma and non small-cell lung cancer. Phase II trial data has been extremely encouraging with regards both clinical outcome and the investigation of the underlying immunological mode-of-action. However, despite the positive phase II data there remains a high failure rate in ...
Most randomised clinical trials of cancer treatment include a few hundred patients or less. Recent statistical papers advocate that sometimes thousands of patients should be entered. In this paper I show that for certain types of cancer trials the 'thousands policy' is not required while for others it is desirable but not feasible. In the latter ...
These instructional materials involve secondary students in simulating a criminal trial concerning teenage drinking. Included are all materials necessary for participation in the 1984 California Mock Trial Competition. Part I of the document describes a hypothetical situation involving a high school senior who faces state felony charges for leaving the ...
ERIC Educational Resources Information Center
Clinical trials are governed by an increasingly stringent regulatory framework, which applies to all levels of trial conduct. Study critical immunological endpoints, which define success or failure in early phase clinical immunological trials, require formal pre-trial validation. In this case ...
... Title : The Right to a Fair Trial in Criminal Cases Involving the Introduction of Classified Information. Descriptive Note : Master's thesis. ...
Necitumumab, a monoclonal antibody directed against EGFR, is currently under development as a treatment for advanced NSCLC. Two Phase III randomized trials are ongoing, testing the addition of necitumumab to first-line platinum-based chemotherapy. In the same setting, cetuximab produced a statistically significant but clinically modest benefit in the whole ...
Development of new drugs for the treatment of drug sensitive and drug resistant tuberculosis is badly needed. Substantial progress has been made in the field and presently six new drug components are in clinical phase I and II trials. Drugs approved for other indications e.g. newer fluoroquinolones and oxazolidinones are also being assessed in human phase II and ...
ABSTRACT: BACKGROUND: An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions on implementation. An initial study of an RTS,S vaccine candidate showed promising efficacy against severe malaria in children in Mozambique. Further evidence of its ...
Adenocarcinoma of the rectum represents about a third of cases of colorectal cancer, with an annual incidence of 12,000 cases in France. On the contrary of colon cancer, the benefice of adjuvant chemotherapy in rectal cancer has not been definitively proved, more because this question was assessed in few recent studies than because negative results. ...
Researchers often include patient-reported outcomes (PROs) in Phase III clinical trials to demonstrate the value of treatment from the patient's perspective. These data are collected as longitudinal repeated measures and are often censored by occurrence of a clinical event that defines a survival time. Hierarchical Bayesian models having latent ...
The dissertation uses the case study format to analyze three sets of randomized clinical trials: the Salk polio vaccine trials of 1954; trials of barrier contraceptives and of IUDS conducted by the Planned Parenthood Federation from 1959-1968; and trials ...
National Technical Information Service (NTIS)
BackgroundThe Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical ...
BackgroundComprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment ...
If negative phase II trial would have no impact on the decision to perform a phase III, the real question becomes, should the phase II trial be done at all?
... In the case of clinical trial V59P18, despite the fact that the transcription error did not have impact on the conclusions for the serogroup C, the trial ...
Center for Biologics Evaluation and Research (CBER)
Jun 16, 2011 ... Description: Statistical comparison of AGDISP prediction were made against data obtained during aerial spray field trials ("Mission III") ...
Treesearch
... Accession Number : ADA111759. Title : Cloud Geometry Analysis of the Smoke Week III Obscuration Trials. Descriptive Note : Final rept.,. ...
State courts of general jurisdiction in the Nation's 75 largest counties disposed of by trial over 15,000 tort, contract, and real property rights cases between January and December 1996. About 70% of the trial cases were decided by a jury and 30% by a ju...
... TITLE: Phase I/II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (RITE) for the Treatment of Hormone Refractory Prostate ...
... I/II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (RITE) for the Treatment of Hormone Refractory Prostate Cancer. ...
This presents the protocol used in the Recurrence Study (Phase III) of the National Cooperative Gallstone Study. The aim of this double-blind, randomized control trial is to determine the following factors in patients from the Phase II trial in whom chole...
