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At least 235 records · Page 13Linked to original sources
PubMed1999

Intraocular pharmacokinetics and safety of a humanized monoclonal antibody in rabbits after intravitreal administration of a solution or a PLGA microsphere formulation.

Poly(lactic-co-glycolic) acid (PLGA) bioresorbable microspheres are used for controlled-release drug delivery and are particularly promising for ocular indications. The objective of the current study was to evaluate the pharmacokinetics and safety of a recombinant human monoclonal antibody (rhuMAb HER2) in rabbits after bolus intravitreal administration of a solution or a PLGA-microsphere formulation. On Day 0, forty-eight male New Zealand white rabbits (2.3-2.6 kg) were immobilized with intramuscular ketamine/xylazine, and the test materials were injected directly into the vitreous compartment. Group 1 animals received rhuMAb HER2 in 50:50 lactide: glycolide PLGA microspheres; Group 2 animals received rhuMAb HER2 in solution (n = 24/group). The dose for each eye was 25 microg (50 microl). After dosing, animals were sacrificed at 2 min, and on 1, 2, 4, 7, 14, 23, 29, 37, 44, 50, and 56 days (n = 2/timepoint/group). Safety assessment included direct ophthalmoscopy, clinical observations, body weight, and hematology and clinical chemistry panels. At necropsy, vitreous and plasma were collected for pharmacokinetics and analysis for antibodies to rhuMAb HER2, and the vitreal pellet (Group 1) was prepared for histologic evaluation. All animals completed the study per protocol-both treatments were well tolerated, and no suppurative or mixed inflammatory cell reaction was observed in the vitreal samples (Group 1) at any of the time points examined. Antibodies to rhuMAb HER2 were detected in plasma samples by Day 7 in both treatment groups, but infrequently in vitreous samples. There were no safety implications associated with this immune response. The in vitro characterization of the PLGA microspheres provided reasonable projections of the in vivo rhuMAb HER2 release kinetics (Group 1). The total amount of antibody that was released was similar in vitro (25.9%) and in vivo (32.4%). RhuMAb HER2 (Group 2) was cleared slowly from the vitreous compartment, with initial and terminal half-lives of 0.9 and 5.6 days, respectively. The volume of distribution approximated the vitreous volume in a rabbit eye.

Animals↗
PubMed2001

People's preferences for safety control: why does baseline risk matter?

Previous tests of how people's valuations of safety vary with the level of baseline risk have left policymakers with a rather mixed message. Some data support the conventional hypothesis derived from economic theory that marginal valuations of risk changes increase with the baseline level, but other data reject it. With these indeterminate findings in mind, the present study adopted an in-depth quantitative-qualitative methodology to explore the preferences of a general population sample (N = 147) for safety programs targeted at hazards with different age groups at risk and numbers of deaths per year. The data clearly showed that self- or household interest mattered to people (e.g., programs in which the respondent or their household members were in the at-risk age group were evaluated more positively). The number of deaths also mattered, although not always for reasons strictly consistent with the conventional hypothesis. Rather, the qualitative findings suggested that evaluations may be driven by auxiliary assumptions about aspects of the programs induced by this information (e.g., people believe that a higher number of deaths is an indicator that more people are likely to be exposed to that hazard). These findings bring into question the extent to which quantitative responses from stated preference surveys can be taken at face value to form a reliable basis for public policy.

Humans↗
PubMed2006

Parental survey of beliefs and practices about bathing and water safety and their children: guidance for drowning prevention.

Drowning represents the second leading cause of unintentional injury death in children less than 19 years. In children less than 5 years, many of these deaths occur in bathtubs. The objective of this study was to describe parental beliefs and practices regarding bathing their children and general water safety to aid in improving anticipatory guidance for drowning prevention. We distributed a written survey about parental beliefs and practices concerning their children's bathing and general water safety to a convenience sample of caregivers. One hundred and thirty-six caregivers participated in the survey providing data for a total of 209 children. Overall, 85% of respondents reported using baby bathtubs, and 46% reported using bath seats when bathing their children. Some caregivers reported leaving a 6-12 months old child unsupervised in the tub, either alone or with a sibling. About half of respondents (52%) indicated that pediatricians discussed water safety and supervision with them, and 36% indicated discussing the proper use of bathing aids with their child's pediatrician. In conclusion, the survey found the majority of caregivers use bathing aids, and caregivers reported some risky behaviors of unsupervised bathing of infants, either alone or with siblings. Better water safety anticipatory guidance is needed for caregivers.

Accident Prevention↗
PubMed1998

Development of a test battery to identify older drivers at risk for self-reported adverse driving events.

OBJECTIVES: The purposes of this study were (1) to develop a battery of tests that assessed a wide range of functional abilities relevant to driving yet could be performed in a clinician's office and (2) to determine which of these tests were most closely associated with self-reported adverse driving events. DESIGN: A cohort study. SETTING: An urban community. PARTICIPANTS: Participants were drawn from the Project Safety cohort, a probability sample of noninstitutionalized older persons in New Haven, Connecticut, initiated in 1989. The current study included surviving, active drivers in the cohort (N=125). MEASURES: The test battery assessed visual, cognitive, and physical abilities potentially relevant to driving, and was administered in participants' homes by trained interviewers between October 1994 and July 1995. Outcome measures included the self-report of a crash, moving violation, or being stopped by police in any Project Safety interview since the inception of the cohort. Analyses compared performance on the elements of the test battery with participants' histories of adverse driving events. RESULTS: Of the 125 drivers, 50 (40%) had reported an adverse event in a mean period of 5.76 (+/-.25) years before the current interview. The elements of the test battery independently associated with a history of events, adjusting for driving frequency, included near visual acuity worse than 20/40 (adjusted odds ratio 11.90), limited neck rotation (OR 6.10), and poor performance on a test of visual attention, the number cancellation task (OR 3.00). The resulting regression equation yielded a sensitivity of 80%, a specificity of 55%, and an area under the curve of .75 by receiver operating characteristic analysis. CONCLUSION: These findings suggest it may be possible to identify individuals potentially at risk for self-reported adverse driving events using simple tests of functional ability. If validated, such an approach could be used to identify individuals who need a more detailed assessment of functional abilities to determine the severity and etiology of impairments, and their effect on driving performance, as well as possible interventions to correct or compensate for the impairments.

Accidents, Traffic↗
PubMed2006

Rural drinking water at supply and household levels: quality and management.

Access to safe drinking water has been an important national goal in Bangladesh and other developing countries. While Bangladesh has almost achieved accepted bacteriological drinking water standards for water supply, high rates of diarrheal disease morbidity indicate that pathogen transmission continues through water supply chain (and other modes). This paper investigates the association between water quality and selected management practices by users at both the supply and household levels in rural Bangladesh. Two hundred and seventy tube-well water samples and 300 water samples from household storage containers were tested for fecal coliform (FC) concentrations over three surveys (during different seasons). The tube-well water samples were tested for arsenic concentration during the first survey. Overall, the FC was low (the median value ranged from 0 to 4 cfu/100ml) in water at the supply point (tube-well water samples) but significantly higher in water samples stored in households. At the supply point, 61% of tube-well water samples met the Bangladesh and WHO standards of FC; however, only 37% of stored water samples met the standards during the first survey. When arsenic contamination was also taken into account, only 52% of the samples met both the minimum microbiological and arsenic content standards of safety. The contamination rate for water samples from covered household storage containers was significantly lower than that of uncovered containers. The rate of water contamination in storage containers was highest during the February-May period. It is shown that safe drinking water was achieved by a combination of a protected and high quality source at the initial point and maintaining quality from the initial supply (source) point through to final consumption. It is recommended that the government and other relevant actors in Bangladesh establish a comprehensive drinking water system that integrates water supply, quality, handling and related educational programs in order to ensure the safety of drinking water supplies.

Arsenic↗
PubMed2002

Environmental factors influencing human viral pathogens and their potential indicator organisms in the blue mussel, Mytilus edulis: the first Scandinavian report.

This study was carried out in order to investigate human enteric virus contaminants in mussels from three sites on the west coast of Sweden, representing a gradient of anthropogenic influence. Mussels were sampled monthly during the period from February 2000 to July 2001 and analyzed for adeno-, entero-, Norwalk-like, and hepatitis A viruses as well as the potential viral indicator organisms somatic coliphages, F-specific RNA bacteriophages, bacteriophages infecting Bacteroides fragilis, and Escherichia coli. The influence of environmental factors such as water temperature, salinity, and land runoff on the occurrence of these microbes was also included in this study. Enteric viruses were found in 50 to 60% of the mussel samples, and there were no pronounced differences between the samples from the three sites. E. coli counts exceeded the limit for category A for shellfish sanitary safety in 40% of the samples from the sites situated in fjords. However, at the site in the outer archipelago, this limit was exceeded only once, in March 2001, when extremely high levels of atypical indole-negative strains of E. coli were registered at all three sites. The environmental factors influenced the occurrence of viruses and phages differently, and therefore, it was hard to find a coexistence between them. This study shows that, for risk assessment, separate modeling should be done for every specific area, with special emphasis on environmental factors such as temperature and land runoff. The present standard for human fecal contamination, E. coli, seems to be an acceptable indicator of only local sanitary contamination; it is not a reliable indicator of viral contaminants in mussels. To protect consumers and get verification of "clean" mussels, it seems necessary to analyze for viruses as well. The use of a molecular index of the human contamination of Swedish shellfish underscores the need for reference laboratories with high-technology facilities.

Animals↗
PubMedDate not supplied

Monitoring of dialysis water systems--is there a need for increased sampling?

Water quality is one of the most important aspects of ensuring a safe and effective delivery of haemodialysis. An extensive microbiological survey of several water systems highlighted a contamination problem which routine sampling had failed to detect. Current guidelines suggest that samples for microbiological and endotoxin analysis should be taken from the outlet of water treatment plant and points expected to have the highest bacterial load, normally the end of the distribution loop and connections to the dialysis machines, where the flow is at its lowest. The survey extended sampling to include a large number of machine connection points. Four systems were investigated. The samples from routine test points generally returned results within our operational limits (<10 CFU/ml and <0.06 IU/ml). However, results from several machine connection points exceeded these limits by a large margin. Several disinfection cycles were required in order to achieve results in keeping with our operational limits. The conclusion is that sample results from the end of the distribution loop may give a false sense of security by not indicating a contamination problem at the machine connection points. Increasing the number and frequency of machine connection points tested should provide greater security in detecting contamination and allow for remedial action at an earlier stage.

Bacteriological Techniques↗
PubMed2005

Food safety knowledge of consumers and the microbiological and temperature status of their refrigerators.

The objectives of this study were to examine domestic food safety knowledge levels of consumers, establish the levels and incidence of bacterial contamination and operational temperatures in domestic refrigerators, and identify areas in which consumer food safety education is necessary in Ireland. A food safety knowledge questionnaire applied to a representative sample of households (n = 1,020) throughout the island of Ireland found the gaps in consumer food safety knowledge. Analysis of swab samples (n = 900) recovered from the domestic refrigerators in these households showed average total viable counts of 7.1 log CFU/cm2 and average total coliform counts of 4.0 log CFU/cm2. Analysis of swab samples also detected the incidence of Staphylococcus aureus (41%), Escherichia coli (6%), Salmonella enterica (7%), Listeria monocytogenes (6%), and Yersinia enterocolitica (2%). Campylobacter jejuni and E. coli O157:H7 were not detected in domestic refrigerators. The temperature profiles of a subset of the sampled refrigerators (100) were monitored for 72 h, and 59% were found to operate, on average, at temperatures above the recommended 5 degrees C. Knowledge and temperature survey results varied considerably, but consumers who scored better in terms of basic food safety knowledge had reduced levels of bacterial contamination in their refrigerators and reported a reduced incidence of food-associated illnesses. This study confirms the effect of basic food hygiene knowledge on hygienic practice and identifies specific areasfor emphasis in the development and delivery of effective food safety risk communication messages to consumers.

Adolescent↗
PubMed1989

Evaluation of radiation safety in 29 central Ohio veterinary practices.

A sample of 29 veterinary practices in Central Ohio were visited to assess radiation safety practices and observance of state regulations. Lead aprons and gloves were usually available, but gloves were not always worn. Protective thyroid collars and lead glasses were not available in any practice, lead shields in only five practices, and lead-lined walls and doors in only two practices. Eighteen practices had none of the required safety notices posted.

Equipment Safety↗
PubMed1994

Efficacy of endovascular treatment of meningiomas: evaluation with matched samples.

PURPOSE: To evaluate the clinical efficacy, cost-effectiveness, and safety of presurgical devascularization of meningiomas. METHODS: Matched samples of embolized and nonembolized groups of meningiomas were compared. The study variables for clinical efficacy were estimated blood loss, number of transfusions, surgical resection time, and length of hospitalization. The cost-effectiveness was evaluated by adjusting all hospital costs to 1991 dollar amounts, and adding additional embolization costs and fees to the hospital cost totals for the embolized group. A qualitative comparison of complications was made. RESULTS: All dependent variables evaluating the clinical efficacy of the procedure (estimate blood loss, 533 cc versus 836 cc; number of transfusions, 0.39 units versus 1.56 units; surgical resection time, 305.8 minutes versus 337.5 minutes; and length of hospitalization, 10.6 days versus 15.0 days) displayed trends of higher means in the nonembolized group; however, only the estimated blood loss and number of transfusions variables were significant. The cost-effectiveness of the procedure was not statistically significant. The mean cost was $29,605 for the embolized group and $38,449 for the nonembolized group. There were three major and nine minor complications in the nonembolized group and zero major and six minor complications in the embolized group. There were four additional minor complications caused by the embolization procedure. CONCLUSION: Endovascular devascularization of meningiomas is beneficial for large meningiomas because it diminishes the necessity of intraoperative transfusions and decreases blood loss. The additional day of hospitalization, emolization costs, and costs of complications do not conversely increase treatment costs. There were no major complications or adverse long-term effects caused by the embolization procedure.

Blood Loss, Surgical↗
PubMed2005

Detection of genetically modified organisms in foreign-made processed foods containing corn and potato.

Investigations of the validity of labeling regarding genetically modified (GM) products were conducted using polymerase chain reaction (PCR) methods for foreign-made processed foods made from corn and potato purchased in the Tokyo area and in the USA. Several kinds of GM crops were detected in 12 of 32 samples of processed corn samples. More than two GM events for which safety reviews have been completed in Japan were simultaneously detected in 10 samples. GM events MON810 and Bt11 were most frequently detected in the samples by qualitative PCR methods. MON810 was detected in 11 of the 12 samples, and Bt11 was detected in 6 of the 12 samples. In addition, Roundup Ready soy was detected in one of the 12 samples. On the other hand, CBH351, for which the safety assessment was withdrawn in Japan, was not detected in any of the 12 samples. A trial quantitative analysis was performed on six of the GM maize qualitatively positive samples. The estimated amounts of GM maize in these samples ranged from 0.2 to 2.8%, except for one sample, which contained 24.1%. For this sample, the total amount found by event-specific quantitative analysis was 23.8%. Additionally, Roundup Ready soy was detected in one sample of 21 potato-processed foods, although GM potatoes were not detected in any sample.

DNA, Plant↗
PubMed2005

[Chorionic villus sampling for prenatal diagnosis: clinical analysis of 36 cases].

OBJECTIVE: To evaluate the safety and clinical value of chorionic villus sampling via the cervix for prenatal diagnosis of early pregnancy. METHOD: Thirty-six women with early pregnancy who required prenatal diagnosis received chorionic villus sampling via the cervix under the guidance by ultrasonography for laboratory examination of the samples. RESULTS: Villus sampling was performed successfully in 27 of the 36 cases in a single operation, whereas a second operation for sampling was needed in another 7 cases, with a total operation success rate of 94.4%;. The side effects included abdominal pain and vaginal bleeding in small quantity. In the 22 women who chose to continue the pregnancy, one woman experienced miscarriage at the 25th gestational week due to premature rupture of the membrane, and all other women gave birth to normal full-term infants. CONCLUSION: Chorionic villus sampling via the cervix under the guidance by ultrasonography is effective and safe for prenatal diagnosis in early pregnancy to help avoid induced abortion in mid-pregnancy and the occurrence of fetal defects.

Adult↗
PubMed1998

Changes in sample size and length of follow-up to maintain power in the coronary artery bypass graft (CABG) patch trial.

The CABG Patch Trial is testing the hypothesis that prophylactic use of implantable cardiac defibrillators (ICDs) will improve survival in high-risk coronary heart disease patients undergoing CABG surgery. The original design called for 800 patients to be randomized to ICD prophylaxis or to no therapy and followed for 2 to 6.5 years (average, 40 months) to a common termination date. Since the ICD pulse generators used in this trial lasted about 42 months, the original design required ICD replacement in many patients. At its first two meetings in 1993, the Data and Safety Monitoring Board (DSMB) formalized a plan to adjust sample size in October 1994 if the control group mortality rate was lower than expected. In June 1994, an unanticipated and unique event--a subpoena from the Office of the Inspector General (OIG)--made it impossible to replace about half of the ICD generators and threatened to shorten follow-up substantially. If follow-up had been stopped on the date originally planned, but without replacing ICDs, the average follow-up would have fallen from 40 months to about 33 months. Also, in October 1994, the control group mortality rate was found to be somewhat lower than expected. Together, the abbreviated follow-up and lower control group mortality threatened to reduce power substantially. The DSMB reviewed several options for restoring power. Because mortality rates in the first month after CABG surgery were about seven times as high as thereafter and because ICD therapy did not reduce surgical mortality (death during the first 30 days), extending the follow-up benefits power more than does increasing the sample size. However, the limit on extending follow-up was 42 months (the expected battery life of the ICD). Data from the ICD-treated group was not reviewed or considered in making the decision. After reviewing many options for restoring power, the DSMB recommended that the sample size be increased from 800 to 900 patients and that almost all patients be followed for 42 months. This recommendation extended follow-up for 2 years beyond the original termination date planned for the trial and dictated that patients close out after 42 months rather than on a common termination date.

Cause of Death↗
PubMed2004

Addition of "near-miss" cases enhances a quality improvement conference.

Medical error is a prominent public issue today. Surgeons, for many decades, have conducted regular and meaningful reviews of most untoward events, which deserve improvement. "Near-miss" is a useful focus for such a conference, in that it avoids a focus on ultimate personal guilt and minimizes exposure to litigation (ie, a nonevent).

Adult↗
PubMed1990

Surveillance of fatal and non-fatal farm injuries in Kentucky.

This report describes one approach to establish a surveillance method of farm injuries. The surveillance system is designed to be used to evaluate ongoing prevention activities related to education, training, and equipment design. To define the subset of information to be included in a surveillance system, existing data were analyzed. The mortality data were death certificates and the morbidity data were from the Farm Accident Survey conducted in 1978, (National Safety Council forms and sampling design). Limitations of the data currently available are discussed; information needs for an agricultural injury surveillance system are presented.

Accidents, Occupational↗
PubMed1992

Differential analysis of animal bone marrow by flow cytometry.

A simple procedure was developed for rapid analysis of animal bone marrow by flow cytometry using the lipophilic cationic dye 3,3'-dihexyloxacarbocyanine iodide [DiOC6(3)]. The batch process allows differentiation of bone marrow cells into lymphoid, erythroid, and myeloid populations and enables classification of erythroid and myeloid cells into proliferating and maturing subpopulations. From these data, myeloid:erythroid (M:E) ratios and maturation indices for erythroid and myeloid cells (EMI and MMI, respectively) can be derived. This procedure provides the opportunity to analyze bone marrow quantitatively and offers distinct advantages to current manual methods in terms of simplicity, throughput, and reproducibility. The method has been tested successfully using marrow from Wistar rats, B6C3F1 mice, beagle dogs, and cynomolgus monkeys. This technique facilitates the evaluation of bone marrow samples taken from preclinical safety studies or from animal colonies of large size.

Animals↗
PubMed2002

Characterization of tetanus toxin, neat and in culture supernatant, by electrospray mass spectrometry.

A method was developed for the liquid chromatographic-mass spectrometric (LC-MS) identification of extremely neurotoxic toxins. The method combines sample treatment in a safety containment and analysis of detoxified material in a common laboratory facility. The method was applied to the characterization of neat tetanus toxin and subsequent identification of the toxin in cell lysate supernatants and culture supernatants from different Clostridium tetani bacteria strains. Characterization of the neat toxin was accomplished by (1) accurate mass measurement of enzyme digest fragments of the toxin and (2) tandem mass spectrometric (MS/MS) amino acid sequencing of selected peptides. Accurate mass measurement proved no longer feasible for the analysis of supernatants, due to the overwhelming presence of peptides from proteins other than toxin. Even when high-molecular-weight proteins were filtered from the lysates and treated, the retained protein fraction yielded too many peptides. However, MS/MS could successfully be applied when the findings from the characterization of neat toxin were employed. Thus, LC-MS/MS of selected precursor ions from trypsin digest fragments yielded specific sequence data for identification of the toxin. This procedure provided reliable identification of the toxin at levels above 1 microg/ml and within a day. Investigations with the method developed will be extended to the botulinum neurotoxins.

Amino Acid Sequence↗