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Potential Subjects (potential + subject)
Selected AbstractsDentine hypersensitivity in subjects recruited for clinical trials: clinical evaluation, prevalence and intra-oral distributionJOURNAL OF ORAL REHABILITATION, Issue 3 2002D. G. Gillam Relatively few studies have reported on the frequency, distribution and severity of dentine hypersensitivity (DH) in subjects recruited for clinical trials of desensitizing agents. Potential subjects (n= 48 M, 81 F, mean age 35·1 years) for inclusion into such a study were screened to determine the extent of the problem. 117 subjects (41 M, 76 F) mean age 24·9 years were clinically examined. Evaluation by questionnaire indicated that the prevalence of DH was proportionately higher in the 20,29·9 years (34·9%), and 30,39·9 years groups (33·3%), respectively. Sensitivity to cold was the main presenting symptom. Tactile (probe) and cold air (dental air syringe) stimuli were used to clinically evaluate DH. Of the teeth eligible for evaluation 1561/3136 (49·8%) responded to either one or both of the test stimuli; 274/3136 (8·7%) responded to tactile only stimulation, 779/3136 (24·8%) to thermal only stimulation and 508/3136 (16·2%) to both tactile and thermal stimulation. Of those teeth responding to the stimuli, 477 (30·6%) were premolars, 437 (28%) incisors, 415 (26·8%) molars and 232 (14·9%) canines. The results agree with those of previously reported studies in that DH is most frequently observed on premolars and that proportionately more teeth are sensitive to evaporative than to tactile stimulation. Furthermore it would appear from the results of the study that tactile is less effective than thermal/evaporative stimulation in the evaluation of DH. [source] Bauxite manufacturing residues from Gardanne (France) and Portovesme (Italy) exert different patterns of pollution and toxicity to sea urchin embryosENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 6 2002Giovanni Pagano Abstract This study was designed to investigate the composition and toxicity of solid residues from bauxite manufacturing plants. Soil and dust samples were collected in the proximity of two bauxite plants (Gardanne, France, and Portovesme, Italy). Samples were analyzed for their content of some selected inorganic contaminants by means of inductively coupled plasma optical emission spectroscopy (ICP-OES) either following acid digestion procedures or by seawater release of soluble components. Toxicity was tested by sea urchin bioassays to evaluate a set of toxicity endpoints including acute embryotoxicity, developmental defects, changes in sperm fertilization success, transmissible damage from sperm to the offspring, and cytogenetic abnormalities. Inorganic analysis showed two distinct sets of inorganic contaminants in Gardanne versus Portovesme, including Al, Cr, Cu, Fe, Mn, Pb, Ti, and Zn; sample composition (seawater-soluble cotaminants) and toxicity showed a noteworthy association. The most severe toxicity to embryogenesis and to sperm fertilization success was exerted by some Portovesme samples (0.03,0.5% w/v), with a significant association between toxicity and dose-related seawater release of Zn, Pb, and Mn. Seawater extraction of a toxic dust sample (G20) from the Gardanne factory showed increasing seawater release of Al, Fe, and Mn; the G20 sample, at the level of 0.5%, affected both developing sea urchin embryos and sperm (offspring quality). Soil samples around the Gardanne factory showed the highest frequency of toxic soil sites eastward from the factory. The present data point to solid deposition from bauxite plants as a potential subject of environmental health concern. The results suggest that extraction methods for evaluating the toxicity of complex mixtures should be based on the environmental availability of mixture components. The differences in sample toxicity among the tested sites, however, suggest possible site-to-site variability in geochemical and/or technological parameters. [source] Binge eating disorder pharmacotherapy clinical trails,who is left out?EUROPEAN EATING DISORDERS REVIEW, Issue 2 2009Anna I. Guerdjikova Abstract Objective This report examined the characteristics of subjects interested in binge eating disorder (BED) pharmacotherapy trails who were ineligible for participation. Methods Data on 2685 potential subjects interested in participating in five different placebo-controlled monotherapy trails of BED were analysed. Results Of the 2685 potential subjects, 1230 (45.8%) were ineligible because they did not meet entry criteria, 586 (21.8%) were eligible for participation, 531 (19.8%) were not interested in the study and 338 (12.6%) were not contacted. Among the 1230 ineligible candidates, 525 (42.7%) were taking exclusionary psychotropic medication, 305 (24.8%) did not meet specified BED criteria, 157 (12.7%) were out of the required age (n,=,83) or weight (n,=,74) range, 212 (17.2%) had prohibited medical (n,=,78) or psychiatric (n,=,134) disorders and 31 (2.5%) were participating in weight loss programmes. Discussion Given the complexity of BED, future pharmacotherapy studies should examine a broader range of subjects, including subjects with subthreshold forms of BED, those with comorbid disorders and elderly subjects. Copyright © 2008 John Wiley & Sons, Ltd and Eating Disorders Association. [source] The North American Immune Tolerance Registry: contributions to the thirty-year experience with immune tolerance therapyHAEMOPHILIA, Issue 1 2009D. DIMICHELE Summary., The North American Immune Tolerance Registry (NAITR) began in 1992 as a project of the ISTH Factor VIII/IX Subcommittee with the goal of further determining immune tolerance induction (ITI) practices in Canada and the United States. This retrospective registry study, published in 2002, was limited in its capacity to provide definitive answers to many unresolved ITI practice issues. Nonetheless, it played a role in developing guidelines for current ITI practice and in generating hypotheses that must now be examined through rigorous prospective data collection efforts. For haemophilia A, the logical next step has been the initiation of international prospective randomized studies of ITI outcome relative to factor VIII (FVIII) dose and purity for subjects with high titre inhibitors. Both trials will additionally provide platforms for translational study of the immunology of tolerance, a prelude to the next generation of safe and effective tolerizing strategies. For the less common problem of FIX inhibitor eradication, prospective randomized studies will not be a feasible way to confirm the NAITR observations. Coordinated international efforts will still be required to prospectively collect data on ITI outcome to document new potentially effective therapeutic strategies for inhibitor eradication. These registries will hopefully also serve to identify potential subjects for scientific studies of immunology of haemophilia B-related allergic phenomena, a devastating complication of FIX antibody development. [source] Costs and Strategies in Minority Recruitment for Osteoporosis Research,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 1 2003Miriam A Marquez Abstract To meet expectations for the participation of minority populations in research, we committed to enroll 140 minority subjects in addition to a random sample of Olmsted County, Minnesota residents (90% white) for a study of risk factors for age-related bone loss and fractures. We successfully enrolled 597 additional minority subjects but encountered specific problems with respect to identification of potential subjects, recruitment, obtaining informed consent, transportation to the study site, and collecting study data. These problems were resolved by observing the tenets of outreach to a diverse study population, namely (1) understand the target population; (2) establish explicit recruitment goals; (3) agree on research plans between study staff and minority communities; (4) continuously evaluate the recruitment process; and (5) maintain lines of communication. Success depended especially on the recruitment of cultural advisors from the different ethnic groups. These special efforts increased the recruitment cost substantially; the total expense of $122,000 for recruiting 550 Asian, Hispanic, and Somali subjects was almost 5-fold higher than the $26,000 required to recruit 699 mostly white study subjects from the population who were contacted by mail. Although it is not impossible to recruit minority subjects, investigators (and grant reviewers) should recognize that significant resources are required to gain access to ethnic communities for research. These results should contribute to more realistic budgets for recruiting minority subjects into clinical research studies. [source] Recommendations on Use of Biomarkers in Alcoholism Treatment TrialsALCOHOLISM, Issue 10 2003John P. Allen Background: Biochemical markers of heavy drinking are playing increasingly prominent roles in alcohol treatment efficacy studies, especially in those designed to evaluate medications. Among these roles are serving as inclusion or exclusion criteria for research participants, corroboration of self-report of drinking status, assessment of the safety of the agent being evaluated, and determination of treatment outcome. Methods: Recent alcohol medication development trials that included biomarker information were reviewed and critiqued from the perspectives of how biomarker measures were used and how findings on them were reported. Results: Although generally the application of biomarkers as inclusion criteria is not recommended, they may aid in exclusion of potential subjects (e.g., elevated liver function measures in trials of agents that could result in liver damage). Biomarkers are most commonly used as indicators of outcome, usually serving as secondary outcome variables. The relationship of outcome findings on biomarker and self-report measures is positive, but only moderate. As used to date, biomarkers of drinking tend to be less sensitive than well-standardized and properly administered self-report measures. Nevertheless, they do provide a useful, unique source of information on drinking status. Conclusions: The contribution of biomarkers to alcoholism clinical research would be enhanced if certain design strategies were incorporated into their application and if critical information were included in the research publication. This article offers a series of recommendations to improve on their use in a research context. [source] Obtaining informed consent for clinical pain research: patients' concerns and informational needs. (University of Pennsylvania Center for Bioethics, Philadelphia, PA) Pain.PAIN PRACTICE, Issue 4 20012001;92:7 Investigators who conduct pain research are required to obtain voluntary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such studies. It is important that the investigators understand the need for information so that they can effectively and clearly describe the research risks and potential benefits that matter to the potential subjects. This study was designed to define information needs that patients have when they decide whether to participate in clinical pain research and identified clinical and demographic variables associate with specific needs. [source] Exception from Informed Consent Enrollment in Emergency Medical Research: Attitudes and AwarenessACADEMIC EMERGENCY MEDICINE, Issue 2 2007Wayne Triner DO Objectives To explore attitudes surrounding exception from informed consent enrollment into research studies. In addition, the authors sought to determine the level of awareness of such an ongoing study among potential subjects, as defined by their presence in an emergency department (ED). Methods A convenience sample of urban academic ED patients and visitors was surveyed during a visit regarding their attitudes and awareness of an emergency exception from informed consent, blood-substitute trial ongoing in the community. Results There was a 13% refusal rate, and 32% of those approached had characteristics that met exclusion criteria. There were 497 surveys analyzed. There was a predominance of women, Caucasians, and persons with at least some college education. Only 39 (8%) of respondents reported awareness of the ongoing blood substitute trial, and only 19 (4%) were able to list a risk or benefit of participation. Education, income, and age were not associated with reported awareness. Male gender, younger age, awareness of the existing exception from informed consent study, and being married were associated with greater acceptability for such enrollment practices. Conclusions The overall awareness of an ongoing exception from informed consent trial after community consultation and notification was low. A population with potential for enrollment in such a study did not demonstrate a high degree of acceptance of such practices. There were differences among certain demographic groups in the degree of acceptance. These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies. [source] Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed ConsentTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2008Maxwell J. Mehlman The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability ("enhancement research") rather than to prevent, cure, or mitigate disease ("health-oriented research"). This essay examines this question in order to ensure that subjects in biomedical enhancement research receive adequate protection. [source] | ||||||||||