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Clinical Trials (836 Books)


Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

 
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Controlled Clinical Studies of Air Pollutant Exposure : Evaluating...

By: Jack D. Hackney

Government Reference Publication

Introduction: This paper focuses on clinical studies of human volunteers deliberately exposed to specific air pollutants. Most such investigations are performed for the express purpose of guiding air quality regulatory decisions. They establish atmospheric conditions in a controlled laboratory setting which are considered relevant to actual ambient polluted atmospheres and attempt to document any health-related effects which result from breathing the laboratory atmospher...

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Statement of Work : Clinical Research Support Services, 02/11/2005...

By: epartment of Health and Human Services

This contract will provide support to principal investigators (PIs) in the Office of Clinical Research (OCR) and Division of Intramural Research (DIR) at the National Institute of Environmental Health Sciences (NIEHS) for all types of clinical research studies, including both observational clinical research studies and interventional clinical trials. Examples of observational studies to be covered by this contract include case report and case series, casecontrol, cross-s...

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Clinical Trials in Cancer Research

By: Edmund A. Gehan

Government Reference Publication

Introduction: The randomized clinical trial was first used for the evaluation of cancer treatments in the mid-1950s (I). Inonly two decades, it has proven to be a useful way oicvlutintgh e relative r.ifcctiveneuftrriitmcnt, and bodv ui knowled-re has hecn developed which provides objective data about cancer treatments. The organization of comparative clinical trials through the cooperative groups program sponsored by the National Cancer Institute in the U.S. and clinical...

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A Pilot Study for Near Real-Time Aerosol Modeling and Air Quality ...

By: Environmental Protection Agency

Excerpt: Partner with the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Environmental Protection Agency (EPA) for technology transfer in the area of grid-based photochemical modeling -- Apply and evaluate the Community Multiscale Air Quality (CMAQ) stateof- science photochemical modeling system on an ongoing basis with special emphasis on PM2.5 predictions -- Assess the potential usefulness of grid-based photochemical models to provide air quality f...

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Content Evaluation Pilot Study

By: J. Gary Van Nest

Statistical Reference Document

Excerpt: The Content Evaluation Pilot Study of the 1982 Economic Censuses was designed to determine the feasibility of conducting a full scale Content Evaluation of the 1987 Economic Censuses for the more complex items on the census questionnaire. The study was also intended to identify problems respondents have had in reporting accurate figures for the more complex items on the census questionnaires and to develop recommendations that will help reduce these reporting pr...

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A Pilot Study for Near Real-Time Aerosol Modeling and Air Quality ...

By: Alice Gilliland

Excerpt: The poster will present the objectives and initial results of a pilot study conducted as a partnership between the U.S. Environmental Protection Agency (U.S. EPA), National Oceanic and Atmospheric Administration (NOAA), and the New York State Department of Environmental Conservation (NYSDEC). The primary objectives of this study are to implement, operate, and evaluate an automated, numerical, model-based air quality forecast system to provide daily predictions o...

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Content Evaluation Pilot Study

By: J. Gary Van Nest

Statistical Reference Document

Excerpt: 1. Executive Summarv The Content Evaluation Pilot Study of the 1982 Economic Censuses was designed to determine the feasibility of conducting a full scale Content Evaluation of the 1987 Economic Censuses for the more complex items on the census questionnaire. The study was also intended to identify problems respondents have had in reporting accurate figures for the more complex items on the census questionnaires and to develop recommendations that will help redu...

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Randomization in Cancer Clinical Trials : Permutation Test and Dev...

By: Yasuo Ohashi

Government Reference Publication

Excerpt: As seen in the guidelines by Simon and Wittes (I), high quality is being required in cancer clinical trial data for raising the reliability and comparability of trials, and this pressure from abroad is now influencing the design and management of cancer clinical trials in Japan. Until a few years ago, the randomization has been done almost exclusively by the envelop method in Japan, and a high rate of ineligibility and protocol violations have often deteriorated...

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New Drug Development: Estimating Entry from Human Clinical Trials

By: Christopher P. Adams

Government Reference Publication

Abstract: This paper analyses a detailed data set on drugs in human clinical trials around the world between 1989 and 2002. The data provides information on the probabilities with which drugs successfully complete the different phases of the trials and the durations of successful completions. The paper shows that success rates and durations can vary substantially across observable characteristics of the drugs, including primary indication, originating company, route of a...

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Feasibility of Using Subject-Collected Dust Samples in Epidemiolog...

By: Samuel J. Arbes

Government Reference Publication

Excerpt: Studies of indoor allergen exposures are often limited by the cost and logistics of sending technicians to homes to collect dust. In this study we evaluated the feasibility of having subjects collect their own dust samples. The objectives were to compare allergen concentrations between subject- and technician-collected samples and to examine the sample return rate. Using a dust collection device and written instructions provided to them by mail, 102 subjects col...

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Profiling the Needs of Young Female Offenders : A Protocol and Pil...

By: Barbara Owen

Government Reference Publication

Excerpt: Child welfare, and alcohol and drug abuse networks, as well as facilities Within the juvenile correctional system. According to Lerman (1991), inadequate data about the characteristics of the juvenile population confrned to these facilities creates problems for developing effective policies and programs which address the needs of this group. Specifically, the lack of information regarding girls confined in juvenile correctional facilities, namely, training schoo...

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Profiling the Needs of Young Female Offenders Instrument Developme...

By: Government Printing Office

Government Reference Publication

Excerpt: The administrative and research staff of the CYA provided critical assistance to us at every stage of this process. We were given active support by Richard Tillson, Deputy Director of Institutions & Camps Branch, Central Office, Vivian Crawford, Superintendent, Ventura School, Elaine Duxbury and Candace Cross-Drew, Central Office Research, Elverta Mock and Gary Collins, Ventura School. Ms. Crawford, Ms. Cross- Drew, and Ms. Mock offered extended assistance throu...

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Profiling the Needs of Young Female Offenders : A Protocol and Pil...

By: Barbara Owen

Legal Reference Publication

Excerpt: Problem statement. While female delinquency has traditionally been overlooked in policy and research, recent initiatives have begun to explore the problems and needs of high risk girls and young women (OJJDP, 1994, p. 1). Chesney-Lind and Shelden (1992) summarize current findings that suggest delinquent females tend to be similar to male delinquents in terms of lower Socioeconomic status, disrupted family backgrounds and school difficulties. Most research argues...

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Profiling the Needs of Young Female Offenders : Instrument Develop...

By: Barbara Owen

Legal Reference Publication

Acknowledgements: The administrative and research staff of the CYA provided critical assistance to us at every stage of this process. We were given active support by Richard Tillson, Deputy Director of Institutions & Camps Branch, Central Office, Vivian Crawford, Superintendent, Ventura School, Elaine Duxbury and Candace Cross-Drew, Central Office Research, Elverta Mock and Gary Collins, Ventura School. Ms. Crawford, Ms. Cross- Drew, and Ms. Mock offered extended assista...

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Community Policing in Action : Lessons from an Observational Study

By: Jeremy Travis

Legal Reference Publication

Excerpt: Community policing?a relatively recent addition to law enforcement?aims to increase interaction and cooperation between local police and the people and neighborhoods they serve. Its goals are to reduce and prevent crime and to increase feelings of safety among residents. Passage of the Violent Crime Control and Law Enforcement Act of 1994 brought Federal support for implementing and evaluating many community policing programs. One study conducted in Indianapolis...

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Clinical Studies of Styrene Workers : Initial Findings

By: William V. Lorimer

Government Reference Publication

Excerpt: About 2.8 million tons of styrene were produced in the United States in 1973, slightly less than toluene and slightly more than vinyl chloride (I) . Polystyrene and styrene polymers (butadiene-styrene, acryonitritile-butadienestyrene for example) production totaled 2.2 million tons in 1974 and was expected to rise to 11 millions tons by the year 2000 (2) . The other major use of styrene is as a crosslinking agent in polyester resin manufacture; 3040% of the volu...

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Managing Clinical Research Data : Software Tools for Hypothesis Ex...

By: C.F. Starmer

Government Reference Publication

Excerpt: The nature of the computational platform on which experimentally derived data are managed and analyzed can play an important role in the quality of a study. For instance, the platform can provide no services to the user, thus forcing a large manual and potentially errorprone effort in data acquisition, preparation, management, and analysis. On the other hand, the platform can provide a wide variety of ancillary services, from basic data handling and quality asse...

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Identification and Characterization of Populations Living Near Hig...

By: Daniel Wartenberg

Government Reference Publication

Excerpt: A complementary approach used ro investigate the association between electric and magnetic fields and cancer has been the study o f tnortality patterns o f workers with high occupntional exposure to electric and magnetic fields. The excess rates of leukemia and brain cancer deaths observed in these studies [e.g., Theriault (11)I have substantiated concern about exposure to electric and magnetic Gelds. But because the actual magnitude of electric and magnetic fie...

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Skeletal Lead Release during Bone Resorption : Effect of Bisphosph...

By: John Eisman

Government Reference Publication

Excerpt: Exposure to lead is still an international public health problem, despite major reductions in its use in industrial processes in developed countries (1). The neurotoxic effects of lead in the fetus, neonate, and infant are well recognized (2). The main reservoir of lead within the body is the skeleton and, until recently, lead was considered to be relatively immobile in this compartment. Recent studies using the stable lead isotope fingerprinting method in nonhu...

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Environmental Organochlorines and Semen Quality : Results of a Pil...

By: David C. Christiani

Government Reference Publication

Excerpt: Currently there is scientific and public concern about whether exposure to ambient levels of so-called endocrine disruptors, such as p,p-DDE [1,1-dichloro-2,2-bis(p-chlorophenyl) ethylene], a metabolite of DDT [1,1,1-dichloro 2,2-bis(p-chlorophenyl)- 1,1,1-trichloroethane], and polychlorinated biphenyls (PCBs), alter semen quality (1,2). This concern stems from studies showing that PCBs and p,p-DDE are found in a large proportion of the general population (3?5),...

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