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PubMed2005

Noise exposures of rail workers at a North American chemical facility.

BACKGROUND: Both continuous and impact noise exposures of rail yards and railways have been historically understudied. We summarize noise exposures to rail workers at a large chemical facility in North America. METHODS: Rail workers were surveyed over the course of three 12-hr shifts. Personal noise dosimeters were used to derive a 12-hr time-weighted average (L(AVG)), an 8-hr time-weighted average (L(TWA)), and a percent dose. Peak and maximum sound levels were also recorded during each sampling period. Six workers were sampled on three separate days for a total of 18 full-shift noise samples. RESULTS: Full-shift noise exposures were all below the Occupational Safety and Health Administration's (OSHA) permissible exposure limit (PEL) and action level for a 12-hr workday. Peak impact sound levels exceeded 140 dB in 17 of 18 samples (94%) with a mean peak sound level of 143.9 dB. Maximum continuous sound levels were greater than 115 dBA in 4 of 18 samples (22%) with a mean maximum sound level of 113.1 dBA. The source of peak impact sound levels was a daily exposure to a concussion caused by a sudden break in a freight airline. CONCLUSIONS: Rail workers at this facility are at risk of noise induced hearing loss from high impact noise exposures. Peak impact and maximum continuous sound levels can be attenuated through the use of hearing protection or by increasing distances from railroad noise sources.

Analysis of Variance↗
PubMed1979

Gas chromatography/mass spectrometry: its application to industrial hygiene analytical problems.

The mass spectrometer (MS), when used as a detector for the gas chromatography yields a system (GC/MS) which is compatible, sensitive, and provides specific information, suitable for qualitative or quantitative analyses for industrial hygiene samples. Examples of the use of two GC/MS/Data Systems utilizing industrial hygiene samples as encountered during the health hazard evaluation efforts of NIOSH (National Institute for Occupational Safety and Health) are presented. A quadrupole unit has been used as a service tool to analyze industrial field samples and a high resolution double focussing unit has been used in the areas of method development research.

Acetylene↗
PubMed1996

Comprehensive drug screening in blood for detecting abused drugs or drugs potentially hazardous for traffic safety.

A comprehensive drug screening procedure for detecting drugs in the blood samples of car drivers suspected of driving under the influence of drugs, is presented. Amphetamines, cannabinoids, opioids, cocaine and benzodiazepines were screened by an immunological EMIT ETS system after acetone precipitation. Gas chromatographic methods were used to screen and quantitate basic, neutral and acidic drugs. The free amino groups of basic drugs were derivatized with heptafluorobutyric anhydride. Analysis was performed by a dual channel gas chromatograph combined with a nitrogen phosphorus and an electron capture detector. Phenyltrimethylammonium hydroxide was used as a methylathing agent for acidic substances before analysis with a gas chromatograph connected to a nitrogen phosphorus detector. A gas chromatograph/mass spectrometry was used as a common confirmation method. Tetrahydrocannabinol was quantitated after bis(trimethylsilyl)trifluoroacetamide derivatization, opiates after pentafluoropropionic anhydride derivatization and benzoylecgonine after pentafluoropropionic anhydride and pentafluoropropanol derivatization. Excluding benzodiazepines, which were confirmed with a gas chromatograph connected to a nitrogen phosphorus and an electron capture detector, the other basic drugs as well as the acidic drugs were confirmed after the same derivatization procedures as in the screening methods. Alcohols were quantitated in triplicate by gas chromatography using three different kinds of columns. Although urine is the most important specimen for screening abused drugs, it has only limited use in forensic toxicology. The described system is most useful for analyzing a wide range of substances, including illicit drugs, benzodiazepines, barbiturates, antidepressants and phenothiazenes in forensic samples when urine is not available.

Accidents, Traffic↗
PubMed2003

Agricultural tasks and injuries among Kentucky farm children: results of the Farm Family Health and Hazard Surveillance Project.

BACKGROUND: This population-based study reports the prevalent agricultural tasks and the 1-year cumulative incidence of injuries in a sample of 999 children < or = 18 years old living on family farms in Kentucky. METHODS: Data were collected in 1994 to 1995 for the National Institute for Occupational Safety and Health Farm Family Health and Hazard Surveillance Project. A random sample of farm children in 60 Kentucky counties was selected using a cross-sectional, two-stage cluster design. Respondents, primarily mothers, completed a 30-minute telephone interview about work-related tasks and injuries experienced by their children while working on the farm. RESULTS: Participation in chores related to tobacco and beef cattle production was common for children aged 5 to 18 years. In a 1-year period, 29 children were injured while performing farm work, yielding a crude rate of 2.8 per 100 children (95% confidence interval, 1.7-3.8). Boys aged 16 to 18 years had the highest injury rate (9.2 per 100 children). Farm machinery, cattle and horses, falls from heights, and contact with inanimate objects were the primary external causes of nonfatal farm work injuries. CONCLUSION: Rates of farm work injuries among adolescent boys may be higher than previously reported for Kentucky and other states. Injury prevention interventions targeted to chores related to tobacco and beef cattle production are particularly relevant for this population of young workers.

Accidents, Occupational↗
PubMed1995

[Intake of addictive drugs and traffic safety--a report of experiences of the Vienna federal police department].

Urine samples of 27 individuals with extremely conspicuous behaviour in road traffic were analysed by means of the Abbott ADx-analyser for cocaine metabolites, cannabinoids and opiates. Gas chromatography/mass spectrometry (GC/MS) confirmed positive results. 52% of those 26 positive samples confirmed the simultaneous consumption of two drugs. In 16% all three drugs tested could be found positive, exceeding the threshold values given for the tests hundred fold. Without exception, all 25 urine samples found positive in the ADx-analyser belonged to young people (22 males, 3 females) with 48% of them born between 1968 and 1970. 84% of tested people had previous convictions and 68% had drug addiction records. We also see this project as the beginning of continuing investigations of other drugs and pharmaceuticals. Given the fact that 25 out of 27 samples were found to be positive we most certainly detected nothing but the "tip of the iceberg". We should strive, in conjunction with other European countries, for a political solution to the problem of the illegal and legal consumption of drugs and pharmaceuticals and their effect on driving performance.

Accidents, Traffic↗
PubMed2006

Overnight orthokeratology experience with XO material.

PURPOSE: To evaluate long-term safety and effectiveness of overnight orthokeratology in a large sample of myopes by using three different lens designs and the highly gas-permeable Boston XO material (Bausch & Lomb, Rochester, NY). METHODS: A total of three hundred forty-two subjects, 99 of whom were juveniles, were enrolled in the investigation at 26 clinical centers in the United States and Canada. Three different lens designs in Boston XO material were used. Subjects were limited to a measured visual need for correction of myopia less than or equal to 4.00 diopters and astigmatism less than or equal to 1.50 diopters with best-corrected Snellen visual acuity of 20/40 or better. Refractive error and unaided visual acuity were used to determine the effectiveness of the procedure at short-term (1 month) and long-term (12 months). The safety of the procedure was determined by the symptoms reported, and slitlamp findings suggested physiologic rejection of the procedure. RESULTS: One hundred thirty-three adults and 68 juveniles completed the 12-month study. More than 60% of the subjects reached 20/20 vision or better at the end of 1 month of overnight lens wear, and this number remained stable during the next 11 months. A reduction in myopia of 70% and of more than 90% was measured at the 1- and 12-month visits, respectively. Safety data indicate a decrease in symptoms and in general a decrease in positive slitlamp findings with time. CONCLUSIONS: The procedure with all three lenses in Boston XO material is effective. However, the safe use of orthokeratology lenses is predicated on the emphasis of clear patient direction on how to wear and take care of the lenses followed by regular examinations by an eye care practitioner.

Adolescent↗
PubMed1988

Transabdominal versus transcervical chorionic villus sampling: a randomized trial.

Chorionic villus sampling (CVS) is still considered to be an applied research method and its safety is under evaluation in randomized trials. Moreover, no knowledge is available about the comparative efficiency and risks of transcervical and transabdominal chorionic villus sampling. A preliminary analysis of the first 639 consecutive cases of an ongoing trial in which cases are randomized between transcervical and transabdominal aspiration techniques shows: (a) an overall sampling success rate of greater than 99% obtained by both techniques; however, the number of repeat insertions of the sampling device was higher for the transcervical route; (b) a significant shift towards lighter tissue samples for the transabdominal route; however, very light specimens, less than 10 mg, were equally distributed in both groups; and (c) approximately 10% of cases underwent a different procedure from the allocated one because of an anatomical or clinical contraindication, with a higher rate of deviation for the transcervical technique.

Abdomen↗
PubMed2001

Factors associated with pilot error in aviation crashes.

BACKGROUND: The importance of pilot error in aviation crashes has long been recognized. However, understanding and preventing pilot error remains the foremost challenge in aviation safety. OBJECTIVE: This study aims to identify pilot characteristics and crash circumstances that are associated with the presence of pilot error in a large sample of aviation crashes. METHODS: Different data files compiled by the National Transportation Safety Board for 329 major airline crashes, 1,627 commuter/air taxi crashes, and 27,935 general aviation crashes for the years 1983-96 were merged; and the presence of pilot error was analyzed in relation to variables indicating the characteristics of the pilot-in-command, crash circumstance, and aircraft. Multivariate logistic regression modeling was performed to assess the associations of individual variables with the likelihood of pilot error given a crash. RESULTS: Pilot error was a probable cause in 38% of the major airline crashes, 74% of the commuter/air taxi crashes, and 85% of the general aviation crashes. Among the factors examined, instrument meteorological condition and on-airport location were each associated with a significantly increased odds of pilot error. The likelihood of pilot error decreased as pilot certificate rating increased in commuter/air taxi and general aviation crashes. Neither pilot age nor gender was independently associated with the odds of pilot error. With adjustment for pilot characteristics and crash circumstances, flight experience as measured in total flight time showed a significant protective effect on pilot error in general aviation crashes. CONCLUSIONS: The prevalence and correlates of pilot error in aviation crashes vary with the type of flight operations. Adverse weather is consistently associated with a significantly elevated likelihood of pilot error, possibly due to increased performance demand.

Accidents, Aviation↗
PubMedDate not supplied

Diagnostic fetal blood sampling-technique related losses.

BACKGROUND: The applications of cordocentesis are limited by its safety. Cordocentesis is performed either freehand or with the aid of a fixed needle guide. Recent reports suggest a loss rate of 1-7% using the freehand technique. The potential influence of technique on the perinatal loss rate has not been examined. STUDY DESIGN: The procedure-related loss rates of two fetal diagnosis and treatment units, one in the United States (10 operators) and one in Japan (15 operators), who perform diagnostic cordocentesis with the aid of a fixed needle guide is calculated from a prospectively maintained database and compared to the published experience of large centers who use a freehand technique. RESULTS: A total of 1,260 diagnostic cordocenteses were performed. The mean gestation at sampling was 29.1 +/- 5 weeks. The umbilical vein was punctured in 90%. There were 12 procedure-related losses yielding an overall perinatal loss rate of 0.9%. There was no relationship between the risk of a loss and the number of prior procedures the operator had performed. Losses were more often associated with puncture of the umbilical artery (41.7 vs. 9.2%, p = 0.002). Eleven of 12 losses were associated with a postprocedure bradycardia. Eight fetuses who died had either a trisomy or triploidy, 1 had renal agenesis, 2 had severe early-onset growth restriction and 1 had rhesus disease. For all diagnoses other than a chromosome abnormality and severe fetal growth restriction, the procedure-related loss rate from diagnostic cordocentesis was 0.2% (2/1,021). CONCLUSION: This study suggests that technique is a variable in the loss rate for cordocentesis.

Bradycardia↗
PubMed2003

Detection of staphylococcal enterotoxin B in spiked food samples.

Contamination of food with infectious agents, intentional or not, is a global concern with far-reaching economic and social impact. Staphylococcal enterotoxins are a major cause of food poisoning, but most methods for the identification of these agents in food require extensive pretreatment or concentration of the sample prior to analysis. The array biosensor was developed as a portable device for the simultaneous analysis of multiple complex samples for multiple targets with minimal sample preparation. In this study, we use an array biosensor to expand and improve on a staphylococcal enterotoxin B (SEB) assay with the ultimate intent of incorporating testing for SEB into a battery of sensitive and convenient assays for food safety validation. In addition to buffer studies, six different types of food samples, including beverages, homogenates of fruit and meat, and carcass washings, were spiked with SEB, incubated for at least 2 h to permit antigen sequestration, and assayed. For all samples, there were differences in fluorescence intensity, but 0.5 ng of SEB per ml could be detected in <20 min with little if any pretreatment and no sample preconcentration.

Biosensing Techniques↗
PubMed1999

A 12-year follow-up of a methadone medical maintenance program.

Methadone Medical Maintenance (MDM) is an alternative for treatment of stable methadone maintained individuals. It involves a monthly physician's visit, at which methadone take-home doses are dispensed to last until the next appointment. The safety and efficacy of this treatment modality is currently under investigation. The purpose of this study was to evaluate the long-term safety and efficacy of MDM in a methadone program in Baltimore. A sample of 21 patients was enrolled in the study and followed for 12 years. They were evaluated once a month by a primary care physician affiliated with a methadone clinic who collected urine toxicology samples and dispensed the monthly methadone dose. The results showed that only 6 (28.6%) patients dropped out during the 12 years of the study. Twelve (0.5%) of 2,290 urine samples collected were positive for drugs. No methadone overdose or diversion was observed. Participants reported significant improvement in their quality of life. The results of this study support the safety and efficacy of medical maintenance of stable methadone maintained individuals.

Adult↗
PubMed2004

Efficacy and safety of donepezil in patients with Alzheimer's disease: results of a global, multinational, clinical experience study.

BACKGROUND: Donepezil has consistently been shown to be effective and well tolerated in the symptomatic treatment of Alzheimer's disease in placebo-controlled clinical trials. It has been shown to provide significant benefits in cognition, global function and activities of daily living in patients with mild-to-moderate Alzheimer's disease. However, in order to control for confounding factors, some clinical trials of donepezil have excluded patients with comorbid illness and concomitant medication use. OBJECTIVE: The objective of this study was to evaluate the efficacy, tolerability and safety of donepezil in a wider and more diverse sample of patients and centres than previous trials, reflecting routine clinical practice. METHODS: In this 12-week, open-label, multicentre trial, patients with probable mild-to-moderate Alzheimer's disease received donepezil 5 mg/day for 28 days, after which the dosage was increased to 10 mg/day according to the investigating clinician's judgement. Patients were enrolled at 246 study centres in 18 countries worldwide. Cognition was assessed by a trained clinician using the Mini-Mental State Examination (MMSE) at baseline, week 4 and week 12 (or last visit). Changes in patient activity and social interaction were evaluated using a caregiver diary. Each week, caregivers recorded their impression of change compared with baseline on three aspects of patient behaviour using a 5-point scale. Efficacy analyses were performed on the intent-to-treat population. Significance was determined using the paired t-test (0.05 significance level). Tolerability and safety were assessed by monitoring adverse events, physical examinations, vital signs, clinical laboratory test abnormalities and ECG findings throughout the study. RESULTS: A total of 1113 patients received donepezil (mean baseline MMSE score [+/-SD] 18.74 +/- 5.21). 989 (88.9%) patients completed the study; 59 (5%) patients discontinued because of adverse events. Most patients were taking at least one concomitant medication (n = 802; 72%) and had at least one comorbid medical condition (n = 745; 67%) on study entry. Donepezil significantly improved cognition compared with baseline at weeks 4 and 12, and at week 12 using a last observation carried forward (LOCF) analysis (all p < 0.0001). Mean change from baseline MMSE score (+/-SE) at week 12-LOCF was +1.73 +/- 0.10. Donepezil was also associated with significant improvements in patient social interaction, engagement and interest, and initiation of pleasurable activities at all weekly assessments and week 12-LOCF (all p < 0.0001). Donepezil was generally well tolerated; adverse events were consistent with the known safety profile of donepezil. CONCLUSION: Donepezil treatment resulted in statistically significant improvements in cognition and patient activity and social behaviour, and was generally well tolerated despite high levels of comorbid illness and concomitant medication use. The results of this open-label study in a large patient population are consistent with those from controlled trials and support that donepezil is effective in the treatment of mild-to-moderate Alzheimer's disease in everyday practice.

Adult↗
PubMed1989

Double-blind study on the influence of picumast dihydrochloride on safety-related performance.

The antiallergic drug picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorobenzyl)piperazin-1-yl]propoxycoumar ine dihydrochloride) was tested in two doses, 2 mg/d and 4 mg/d, in a double-blind group comparison versus placebo using a sample of 48 healthy adult volunteers to determine any effects on safety-related performance in the initial phase of treatment and at steady state. Besides seven test procedures covering concentration and reaction performance, visual orientation, eye-hand coordination and vigilance, a survey of subjective well-being was taken using two different methods. Additionally, after reaching steady state, the tests took place and the survey of well-being was carried out in combination with 0.5% blood alcohol concentration. With both doses of picumast dihydrochloride neither statistically significant nor clinically relevant effects were established in the performance or the well-being of the subjects. This also applies in the case of combination with ethyl alcohol.

Adult↗
PubMed2002

Pharmacokinetics and tolerability of lidocaine patch 5% with extended dosing.

OBJECTIVE: To assess the pharmacokinetics, safety, and tolerability of lidocaine delivered via 4 lidocaine 5% patches applied for 18 h/d for 3 consecutive days in healthy volunteers. METHODS: A prospective, nonrandomized, open-label trial was conducted to determine the pharmacokinetics of 4 lidocaine patches 5% applied to the backs of 20 volunteers on days 1, 2, and 3. On each day, serum samples were collected prior to, during, and after patch application. Safety and tolerability assessments included skin evaluations, monitoring of clinical adverse events and vital signs, 12-lead electrocardiograms, and laboratory testing. RESULTS: For days 1, 2, and 3, the mean +/- SD maximum concentrations were 145.1 +/- 42.4, 153.0 +/- 40.7, and 153.8 +/- 51.4 ng/mL, respectively; the median times to peak plasma concentration were 18.0, 16.5, and 16.5 hours, respectively; the mean +/- SD trough concentrations were 83.0 +/- 29.0, 85.7 +/- 31.1, and 77.0 +/- 26.9 ng/mL, respectively; and the mean +/- SD AUCs over 24 hours were 2089.2 +/- 632.5, 2659.2 +/- 726.8, and 2675.7 +/- 819.2 ng.h/mL, respectively. The patch was well tolerated; local skin reactions were generally minimal and self-limited. CONCLUSIONS: The application of 4 lidocaine patches 5% for 18 h/d for 3 consecutive days is well tolerated; steady-state plasma concentrations are achieved within 3 days. Maximum plasma concentrations of lidocaine are similar to those reported in a previous study with 3 lidocaine patches 5% applied for 12 h/d for 3 consecutive days.

Administration, Topical↗
PubMedDate not supplied

Health and safety problems and lack of information among international visitors backpacking through North Queensland.

BACKGROUND: International visitors to tropical Australia may be exposed to health and safety problems. Because they are younger, stay longer and participate in more activities, backpackers have a greater exposure to such problems than other visitors. METHOD: The study's aim was to determine how many backpackers experience problems and lack health and safety information. Four hundred and thirty-one international visitors staying in a random sample of youth hostels and backpacker accommodation in Townsville were surveyed over the summer. RESULTS: Sixty two percent experienced a health and safety problem, commonly, insect bites, sunburn, headaches, lacerations, coral cuts, ear infections and diarrhea. Seventeen percent resolved only with professional help. Only 54% of backpackers had been offered health and safety information prior to departure, mainly vaccination advice. CONCLUSION: The proportion of backpackers offered health and safety information about tropical Australia, and the breadth of that information, needs to be increased.

Adult↗
PubMed2002

Comparative evaluation of efficacy and safety profile of three anti-tuberculous regimens in Mangalore.

The aim of our study was to evaluate and compare the therapeutic efficacy & safety profile of three different antituberculous regimens for pulmonary tuberculosis. The study sample size included 90 newly diagnosed, sputum positive patients of pulmonary. tuberculosis. 30 each from different groups. The parameters studied were, therapeutic efficacy included weight gain, cough, sputum examination and safety profile: nausea, vomiting, anorexia, gastritis, hepatitis, jaundice diarrhoea, rashes, dizziness, tingling & numbness, flu like symptoms & joint aches. Group-I showed statistically significant weight gain when compared to Group-II. Improvement in cough and conversion to smear negative were seen in 100% of patients in Group-I, 83.3% of patients in Group-II and 93.3% of patients in Group-III. Therapeutic efficacy was highest with Group I regimen, followed by Group III and Group II which was least efficacious. Group II also registered; the maximum cost and highest incidence of adverse effects.

Adult↗
PubMed1995

AIDS: awareness and blood handling practices of health care workers in Lagos, Nigeria.

A questionnaire survey of 260 health care workers from 13 randomly selected health care facilities was undertaken. Their knowledge, attitude, belief and blood handling practices regarding HIV/AIDS were enquired about. Virtually all (99.0%) respondents had heard about AIDS but only 57.0% had seen an AIDS patient before. Although 83.0% knew that AIDS is caused by a virus, a high proportion still confuses mode of transmission with causative agent. Deficient knowledge was exhibited when asked about groups of people who were at a higher risk of contracting HIV and AIDS: Only 54.6% and 51.5% identified homosexuals and i.v. drug users as being at a higher risk. Almost all (97.0%) of our respondents claimed to have been more careful in their blood handling practices since the emergence of AIDS, 68.5% wore gloves for all procedures involving handling of blood and 28.5% sometimes although as many as 30.4%, 40.4% and 18.1% do not wear gloves for cleaning up blood stained materials, nursing procedures and taking obstetric delivery respectively. It was evident from their responses that not all the health workers knew the correct method for disposing of used bloodstained instruments and left-over blood samples and neither were they all adhering to the safety guidelines recommended for handling these materials. Education of all health care workers in Nigeria on the Universal Precautions Guidelines issued by the Centers for Disease Control (CDC) in 1987 regarding blood, body fluids and contaminated instruments' handling precautions is urgently recommended.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Safety, tolerance, and pharmacokinetics of atevirdine mesylate (U-87201E) in asymptomatic human immunodeficiency virus-infected patients.

Atevirdine mesylate (U-87201E) is a new nonnucleoside (bisheteroarylpiperazine) inhibitor of human immunodeficiency virus type 1 reverse transcriptase. In a double-blind, escalating single-dose study the safety, tolerance, and pharmacokinetics of atevirdine mesylate were investigated in 24 asymptomatic human immunodeficiency virus-seropositive male patients. Each patient received one single oral dose of atevirdine mesylate and placebo separated by an interval of 1 to 3 weeks. For each dose level (400, 800, 1,200, and 1,600 mg) six patients received drug and placebo on separate occasions. Blood samples were collected before dosing and at intervals afterward for safety evaluation and estimation of atevirdine and metabolite levels. The concentrations of atevirdine and its principal metabolite (U-89255) in serum were determined by high-performance liquid chromatography. The results of the study showed that atevirdine mesylate is well tolerated at all dose levels. No clinically significant effects on vital signs, electrocardiograms, or laboratory tests were observed. Occasional headache and nausea were reported both in the drug group and in the placebo group. The times to peak values were relatively short (0.5 to 1.0 h), suggesting a rapid absorption. The maximum concentrations of drug in serum were 1.4 microM (400 mg), 4.2 microM (800 mg), 7.3 microM (1,200 mg), and 5.8 microM (1,600 mg). The values of the pharmacokinetic parameters for atevirdine were found to have relatively large intersubject variabilities, and consequently, the study had little power to detect dose-dependent changes in the values of the pharmacokinetic parameters. The oral clearance of atevirdine tended to increase by 90% as the atevirdine mesylate doses increased from 400 to 1,600 mg, but this change in oral clearance was not statistically significant. The values of the pharmacokinetic parameters determined in the study were similar to those found in a previous single-dose study in healthy volunteers.

Adult↗