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At least 415 records · Page 23Linked to original sources
PubMed2006

Transretinal choroidal tumor biopsy with a 25-gauge vitrector.

OBJECTIVE: To describe and evaluate transretinal biopsy of choroidal tumors using 25-gauge vitrectomy instrumentation. DESIGN: Retrospective, consecutive, noncomparative case series. PARTICIPANTS: Fourteen patients undergoing choroidal tumor biopsy at an ocular oncology center. METHODS: The biopsies were performed under local or general anesthesia, alone or in combination with ruthenium plaque or tantalum marker insertion. Immunohistochemistry was performed on all samples, and some melanomas were also analyzed cytogenetically. RESULTS: Surgery was uneventful in all cases. A positive tissue diagnosis was made in 13 of 14 patients, albeit at the second attempt in 1 patient. The only failure occurred because the tumor was calcified. CONCLUSION: Transretinal choroidal biopsy with 25-gauge instrumentation yields a larger sample than fine-needle aspiration biopsy, usually producing sufficient tissue for cytogenetic studies. We did not identify safety concerns in this series of patients. Insufficient samples can occur in some patients, and further studies are needed to understand the reason for such failure.

Adenocarcinoma↗
PubMed2004

Pharmacokinetics, metabolism and excretion of intravenous [l4C]-palonosetron in healthy human volunteers.

Palonosetron (Aloxi(R), Onicit(R)) is a potent, single stereoisomeric 5-HT(3) receptor antagonist developed to prevent chemotherapy-induced nausea and vomiting. The pharmacokinetics and metabolic disposition of a single intravenous [(14)C]-palonosetron (10 microg/kg, 0.8 microCi/kg) bolus dose were evaluated in six healthy volunteers (three males, three females) using serial blood, plasma, urine and fecal samples obtained over 10 days. The safety, tolerability and cardiac effects were assessed. Radiolabeled metabolic characterization revealed that unchanged palonosetron accounted for 71.9% of the total radioactivity in plasma over 96 h, with an extensive distribution volume (8.34 l/kg) and mean plasma elimination half-life of 37 h. Approximately 83% of the dose was recovered in urine ( approximately 40% as unchanged drug, with 50% metabolized; M9 and M4 were the major metabolites) and 3.4% in feces. Hydrolysis of urine samples suggests that the metabolites are not beta-glucuronide or sulfate conjugates of the parent drug or metabolites. The blood to plasma concentration ratio of the total radioactivity was 1.2, on average, indicating little selective partitioning in erythrocytes. Palonosetron was generally well tolerated; headache was the most frequently reported adverse event. Electrocardiograms and 72 h Holter monitoring revealed no clinically significant changes. Palonosetron circulates in plasma mainly as the parent drug. Renal elimination is the primary excretion route, with parent drug and metabolites M9 and M4 accounting for the majority of palonosetron disposition. These results indicate that both renal and hepatic routes are involved in the elimination of palonosetron from the body.

Adult↗
PubMed1989

Relative efficiency and risk of endomyocardial biopsy: comparisons in heart transplant and nontransplant patients.

Right ventricular endomyocardial biopsy remains the gold standard for the diagnosis of acute rejection of the cardiac allograft. Among 704 consecutive procedures performed in 39 transplant recipients (2,842 myocardial samples), endomyocardial biopsy by either the right internal jugular (n = 661) or the femoral venous (n = 43) approach was compared with 243 consecutive procedures performed in nontransplant patients (n = 149 and n = 94, internal jugular and femoral approach, respectively). The internal jugular vein could not be located in only 0.61% (4/661) of heart transplant versus 5% (7/149) of nontransplant procedures (P less than 0.001). Vascular access plus sufficient myocardial sampling was obtained in all but 0.61% (4/661) internal jugular procedures performed in heart transplant patients and in all but 7% (11/149) of those performed in nontransplant patients (P less than 0.0001). (Vascular access was achieved in all femoral venous procedures performed in both transplant and nontransplant patients; sampling was successful after vascular access in all heart transplant recipients and all but two [2.1%] nontransplant procedures.) Cardiac complications occurred in nontransplant patients after one internal jugular procedure (cardiac perforation with tamponade) and after one femoral venous procedure (pericardial effusion). No cardiac complications occurred in transplant recipients, but 2 other complications were observed: One local abscess and one superior vena caval perforation with hemothorax associated with hypotension, both after an internal jugular approach. The overall efficiency (no safety problem; vascular access and adequate sample) was higher among transplant than nontransplant procedures (99% vs 93%, respectively, P less than 0.0001). These observations continue to support routine application of endomyocardial biopsy for monitoring rejection in cardiac transplant patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1995

Consumer product-related ocular trauma.

Leading causes of consumer product-related ocular trauma have not been well described. To delineate these causes in a nationally representative sample, data collected by the US Consumer Product Safety Commission (USCPSC) were reviewed. Data were obtained from the National Electronic Injury Surveillance System (NEISS), a national probability sample survey conducted by USCPSC that continuously monitors consumer product-related injuries treated in hospital emergency rooms across the United States. These data formulated the product summary report for the calendar year 1991. The sampling frame for the NEISS consisted of hospitals listed on the Center for Health Statistics Master Inventory File stratified geographically by size of hospital and number of emergency-room visits. During the calendar year 1991, there were a nationally estimated 298,852 consumer product-related eye injuries treated in hospital emergency rooms. Appoximately 500 different products were implicated in these injuries, with the leading cause being contact lenses (hard and soft), accounting for an estimated 26,490 emergency-room visits. This is followed by welding equipment (12,771 visits), hair curlers/curling irons (5946 visits), and workshop power grinders (5476 visits). Consumer products account for a sizable number of ocular injuries requiring treatment in hospital emergency rooms. Research on outcomes and prevention strategies of the injuries is warranted.

Adolescent↗
PubMed2006

Total arsenic, inorganic arsenic, lead and cadmium contents in edible seaweed sold in Spain.

Total arsenic, inorganic arsenic, lead and cadmium contents were determined in 112 samples of seaweed preparations sold in Spain (seaweed packed in plastic or cardboard box, seaweed in the form of tablets and concentrates, foods containing seaweed, and canned seaweed). The concentration ranges found, expressed in mg/kg, dry weight, were: total As (0.031-149), inorganic As (<0.014-117), Pb (<0.050-12.1) and Cd (<0.003-3.55). For all the contaminants there were failures to comply with legislated values. In particular, all the samples of Hizikia fusiforme exceeded the inorganic As limit established in some countries, and a considerable number of species exceeded the Cd limit set by international regulations. With respect to food safety, consumption of 3 g/day of the samples analysed could represent up to 15% of the respective Tolerable Daily Intakes (TDI) established by the WHO. The situation is especially alarming for intake of inorganic As from H. fusiforme, which can be three times the TDI established.

Arsenic↗
PubMedDate not supplied

First-time proof of endometrial safety of the special black cohosh extract (Actaea or Cimicifuga racemosa extract) CR BNO 1055.

OBJECTIVE: To investigate endometrial safety by assessment of endometrial biopsy samples and the tolerability and efficacy of the special Actaea or Cimicifuga racemosa extract (CR BNO 1055). DESIGN: Four hundred postmenopausal women with symptoms related to estrogen deficiency were enrolled into a prospective, open-label, multinational, multicenter study. Treatment duration (daily dose corresponds to 40 mg of herbal drug) was 52 weeks. To determine the probability of endometrial hyperplasia and more serious adverse endometrial outcome, the point estimator and upper limit of 95% CI were calculated. Descriptive statistics was used to assess the secondary endpoints. RESULTS: Endometrial safety has been proven because no case of hyperplasia or more serious adverse endometrial outcome occurred (point estimate: 0.0; upper limit of 95% CI: 0.011). Endometrial thickness, which was measured by endovaginal ultrasonography, did not show an increase. The number and intensity of hot flushes were markedly decreased. The dropout rate was less than 10%. The overall tolerability was good. CONCLUSIONS: The lack of endometrial proliferation and improvement of climacteric complaints as well as only few gynecologic organ-related adverse events are reported for the first time after a treatment period of 1 year. Due to the improved benefit:risk ratio, it must be assumed that the Cimicifuga racemosa special extract BNO 1055 is a safe alternative for treatment of climacteric complaints.

Administration, Oral↗
PubMed1987

The use of new field methods of semen analysis in the study of occupational hazards to reproduction: the example of ethylene dibromide.

Increasing attention has been paid to the use of semen analysis as an indicator of exposure to potential mutagenic and reproductive hazards. In the infertility clinic setting, semen evaluations include the measurement of sperm concentration, volume, pH, motility, velocity and morphology, the analysis of seminal plasma to evaluate accessory sex gland function and, in some cases, the in vitro evaluation of fertilization capacity and sperm-cervical mucus interaction (Ann Intern Med 1985;103:906-919). To date, however, the study of semen characteristics of occupationally exposed populations has been confined principally to the measurement of sperm concentration and sperm morphology. This has been largely due to the unavailability of portable equipment suitable for the measurement of other semen characteristics and the difficulty of obtaining fresh semen samples in the field setting. National Institute for Occupational Safety and Health researchers have developed mobile laboratory facilities which enable us to evaluate fresh samples, in the field, for semen characteristics in addition to concentration and morphology. This paper describes the application of these methods using the example of our recent cross-sectional study of workers occupationally exposed to ethylene dibromide in the papaya fumigation industry. We discuss our findings in the context of the usefulness of semen analysis as an indicator of occupational hazards to male reproduction.

Environmental Exposure↗
PubMed2005

The effect of seating location on the injury of properly restrained children in child safety seats.

Properly restrained child passengers in the National Automotive Sampling System (NASS), General Estimates System (GES), were studied for the effect of seating position on the risk of injury. The analysis focused on children seated in a child safety seat in a rear seat location. A multiple logistic regression model was used to assess whether the center rear seat is a safer seating position than either of the outboard rear seats. Standard errors for the odds ratios (ORs) of injury for several correlates of injury including seating position were obtained using a jackknife procedure. This analysis of the data showed that the center rear seat is not a safer seating position than either of the outboard rear seats in terms of odds of injury (left seat OR = 0.88, 95% CI = 0.73-1.03; right seat OR = 1.03, 95% CI = 0.85-1.20). These results do not agree with those of previous studies that suggested the center rear seat is the safest position for parents to place a child safety seat.

Accidents, Traffic↗
PubMed2005

Spa, springs and safety.

Natural mineral water has long been used worldwide for bathing and health purposes. At present, Thailand is famous for health spas and natural hot springs among local people and tourists. Due to possible risks of exposure to harmful agents, we studied hazardous pollutants at 57 natural hot springs from 11 provinces in northern, central, eastern and southern Thailand. Pathogenic, free-living amebae of the genera Naegleria and Acanthamoeba, which can cause central nervous system infection, were found in 26.3% (15/57) and 15.8% (9/ 57), respectively. Dissolved radon, a soil gas with carcinogenic properties, was present in nearly all hot springs sites, with concentration ranging from 0.87-76,527 Becquerels/m3. There were 5 water samples in which radon concentration exceeded the safety limit for drinking. Legionella pneumoniphila (serogroups 1, 3, 5, 6, 7 10 and 13) were found in samples from 71.9% (41/57) of studied sites. Because spas and natural springs are popular tourist attractions, health authorities should be aware of possible hazards and provide tactful measures and guidelines to ensure safety without causing undue alarm to foreign and Thai tourists.

Acanthamoeba↗
PubMed2001

Self-reports of safe driving behaviors in relationship to sex, age, education and income in the US adult driving population.

This study analyzed the data of a health and safety survey conducted on a representative sample of the adult driving population. The analysis focused on the relationships between self-reported safe driving behaviors (including belt use, observing speed limits, and abstaining from drinking and driving), and demographic characteristics (including sex, age, education and income). The results showed that the three behaviors are quite independent of each other, and, contrary to some stereotypes, there is no single high-risk group that is most likely to violate all three safe driving behaviors. The only consistent effect was that of sex: women reported higher observance rates of all three behaviors. Reported use of safety belts increases with age and education for both men and women. However while for women the reported use increases with income, for males the reported use does not change with income. Complete avoidance of drinking and driving was reported by most drivers in all groups, and the high rates hardly varied across the different age, education, and income groups. The number of people who reported that they observe the speed limit all the time increased with age, but decreased with increasing education and income. The results have implications for identifying violation-specific high-risk groups, and stressing different factors for each.

Adult↗
PubMed2003

Postoperative pain management on surgical wards-impact of database documentation of anesthesia organized services.

Postoperative pain management (POPM) should be based on an organization exploiting existing expertise and documenting the outcome of the POPM in each individual patient. The aims of the present study were to evaluate the adequacy of database documentation of POPM of an anesthesia organized, nurse-based, anesthesiologist-supervised acute pain service (APS) on surgical wards and to assess to what extent the information obtained was continuously used to improve practice. From 2890 registered cases in the database (patient controlled analgesia, n = 1975; epidural analgesia [EDA], n = 915), a homogeneous two-year sample of documentation charts from use of EDA for POPM in connection with major, open, abdominal surgical procedures (n = 381) was chosen for detailed analysis. The data charts contained information on patient data, drug dosage, total amount of infused drug, duration of EDA treatment, occurrence of side effects, and patient's level of satisfaction. The database information was easily accessible making assessment of relevant aspects of the routines, including associations between analgesic technique, patient related factors, and satisfaction with the services, immediately available. Only 58% of the data charts were properly completed and fed into the database but the clinical safety of the missing nondatabase documented sample was not found jeopardized. Although the database documentation routines were considered to fulfill basic requirements of data collection and monitoring of the appropriateness of POPM, they were not found to function optimally. The reason seemed to be inadequate feedback of information between the parties involved in the POPM services. The present study stresses the importance of establishing routines for adequate, continuous feedback of recorded audit data from the APS team to the surgical wards for the maintenance of a high level of compliance with accepted guidelines.

Adolescent↗
PubMed2005

Quantifying the influence of safety management on the reliability of safety barriers.

A methodology is described that enables to use safety management audit assessments and safety culture questionnaire results for estimating the reductions in the reliability of safety barriers in major hazard plants. The critical issue is the establishment of weight factors in combination with the anchoring of "good" safety management. A method is proposed to derive weight factors from statistical accident analysis in combination with a statistical analysis of safety management assessments at a representative sample of major hazard industries. A preliminary set of weight factors is presented with some examples of resulting reductions in reliability--this demonstration confirms that the set of weight factors needs further development.

Accidents, Occupational↗
PubMed2005

Perceptions of the impact of depression and anxiety and the medication for these conditions on safety in the workplace.

BACKGROUND: The number of people taking prescribed medication for anxiety and depression has increased greatly, but little is known of how this medication impacts on safety at work. AIMS: To examine the relation between anxiety and depression, prescribed medication, performance, and safety in the workplace. METHODS: The research involved nine focus groups with sufferers of anxiety and depression to investigate experiences of mental health problems and the impact of psychotropic drugs. A further three focus groups were conducted with staff in human resources, personnel, occupational health, and health and safety departments, to explore organisational perspectives. The sample comprised 74 individuals drawn from a wide range of occupational sectors. Finally, the results were presented to a panel of experts from occupational medicine, general practice, psychology, health and safety, and psychiatry, to consider the implications for practice. RESULTS: Workers reported that both the symptoms and the medication impaired work performance. Participants described accidents which they attributed to their condition or to the medication. Workers with responsibilities for others, such as teachers, healthcare workers, and managers appeared to present a particular safety risk. Healthcare workers believed that they placed themselves and their patients at risk when carrying out medical procedures. CONCLUSIONS: Respondents in this study felt that their symptoms of anxiety and depression and the medication they took to treat these conditions placed them at risk with respect to safety in the workplace. Drawing on the results, the authors outline areas for improvement in the management of mental health problems at work.

Accidents, Occupational↗
PubMed2005

Safety of mixture of morphine with ketamine for postoperative patient-controlled analgesia: an audit with 1026 patients.

BACKGROUND: Adding ketamine to morphine for patient-controlled analgesia (PCA) may be useful. However, data on this drug combination have been collected on small sample sizes. In order to evaluate the safety of the combination morphine- ketamine, we conducted a prospective study on a large patient population. METHODS: Patient-controlled analgesia was performed with 1026 patients using morphine and ketamine in a dose ratio of 1:1. All patients were treated in the ward. Prospectively collected data included incidence of complications and side-effects, verbal pain scores at rest and during mobilization (0 = no pain to 4 = very strong pain), consumption of morphine and ketamine and patient satisfaction (0 = very un-satisfied to 3 = very satisfied). RESULTS: The study included 462 women and 564 men who underwent, on average, 71.8 h (+/-56.1) of PCA. There were 698 orthopaedic, 160 abdominal, 96 thoracic, 20 vascular, 16 plastic, 15 neurosurgical, 11 urologic and 10 other surgical procedures. No complication was observed. Incidence of side-effects was: 1.2% respiratory depression, 23.5% nausea, 6.2% vivid dreams and/or hallucinations, 21.4% sedation and 10.3% pruritus. Reasons for discontinuing the PCA were side-effects (7.0%) and other (0.5%). Mean pain scores over the whole period were 0.44 (+/-0.54) at rest and 1.36 (+/-0.62) during mobilization. Mean satisfaction score was 2.52 (+/-0.69). CONCLUSION: Patient-controlled analgesia with morphine and ketamine is safe. It produces side-effects which, however, are infrequently a reason for discontinuing the regimen. It is also associated with low pain scores and high patient satisfaction.

Adolescent↗
PubMed1990

Perception of prescription drug risks: a survey of patients with ankylosing spondylitis.

The ways in which patients perceive the risks of prescription drugs are likely to influence treatment preferences and compliance decisions. But very little is known about the perceived frequency of adverse drug reactions (ADR), their perceived causation and attitudes towards the safety regulation of prescription drugs. A sample of 1,034 patients with ankylosing spondylitis (AS) completed a postal questionnaire on the risks of medicines in general and nonsteroidal antiinflammatory drugs (NSAID) in particular. Serious ADR were perceived to be more frequent with NSAID than prescription drugs generally, and those who had experienced a previous ADR (47%) judged ADR to be more frequent (p less than 0.001). When asked to rate the likelihood that each of 7 reasons were causative of ADR, the most likely reason was perceived to be inadequate information to the patient about the drug, and secondly inadequate patient followup by the prescribing doctor. Responses to a hypothetical AS drug risk scenario indicated high safety expectations for antirheumatic agents; 61% thought that the government should take a drug off the market if there is any evidence of fatal ADR. The results of this survey suggest the need for greater patient information and education on the risks and benefits of medicines to modify perceptions and false expectations.

Adult↗
PubMed1996

Therapeutic effect and safety of adjunctive risperidone in refractory obsessive-compulsive disorder (OCD).

It has been well established that more than 40 percent of patients with obsessive-compulsive disorder (OCD) do not improve after an adequate trial with serotonin uptake inhibitors (SUIs). The first purpose of this trial was to compare the short-term efficacy and safety of two different strategies in a sample of treatment-refractory OCD patients: dose increase of the ongoing treatment versus the addition of another SUI. The second purpose was to investigate the short-term efficacy and safety of adjunctive risperidone in SUI-refractory OCD patients. Thirty-three OCD patients who were unimproved after a short-term treatment with clomipramine (150 mg/day) were admitted to the study. In the first part of the study, the dose increase of clomipramine was compared with sertraline addition, in an open-label manner. The addition of sertraline to the ongoing treatment appeared to be more effective and tolerable than the clomipramine dose increase. Seven (50%) of the 14 patients who were considered nonresponders after the first part of the study, showed good clinical improvement and good tolerability after risperidone augmentation. These results suggest that risperidone addition to ongoing SUIs may be useful in augmenting pharmacologic response in OCD.

Adult↗
PubMed2001

Challenges in the development, licensure, and use of combination vaccines.

Before substantial public health benefits associated with use of combination vaccines can be realized, a variety of challenges must be addressed. In February 2000, the National Vaccine Program Office convened the International Symposium on Combination Vaccines to explore solutions for barriers to development, licensure, and use of safe and effective combination vaccines. The symposium focused on the following questions: (1) What immunologic standards should be used to evaluate new combination vaccines? (2) How should correlates of protection be developed, and how should the data they provide be interpreted? (3) What sample size is adequate for prelicensure safety trials of combination vaccines? (4) Should standards for evaluation of combination vaccines containing licensed components be different from standards for evaluation of combinations containing unlicensed components? (5) How can the "great expectations" of postlicensure surveillance be realized? Available data relevant to these issues were presented, providing a foundation for furthering the science of combination vaccines.

Clinical Trials as Topic↗
PubMed2006

Brazilian mothers' knowledge about home dangers and safety precautions: an initial evaluation.

Worldwide, unintentional injuries are a major cause of emergency department visits, hospitalization, permanent disability, and death among children. Today, unintentional injuries are the leading cause of death in children aged 1-14 years in South American countries, including Brazil and Argentina. The majority of unintentional injuries happen in or near the home, and researchers have pointed out that prevention efforts should include the active involvement of parents and caregivers. The ability to identify dangerous situations, products, and behaviors, and to provide suitable precautions, is important if parents are to provide a safe environment for their children as well as for themselves. Despite the overwhelming evidence concerning the relevance of the topic, few studies have focused on parenting knowledge about home safety. This is especially true in developing countries. The present work had three objectives. First, we evaluated the cultural adequacy of the illustrated version of the Home Inventory for Dangers and Safety Precautions (HIDSP-4) in a Brazilian context. Second, we evaluated Brazilian mothers' knowledge about home dangers and safety precautions (based on a convenience sample of 96 mothers resident in Rio de Janeiro). Finally, we analyzed associations between scores in the HIDSP-4 and sociodemographic variables (e.g., educational attainment, socioeconomic status (SES)). It was verified that the inventory suitably covers home dangers identified by Brazilian epidemiological studies on unintentional injuries, and presented satisfactory psychometric properties and cultural adequacy for Brazilian contexts. Brazilian mothers identified 62% of the dangers presented in the illustrations and provided suitable precautions for 26% of the dangers. These results indicate that mothers had some difficulty in identifying home dangers and even more difficulty providing suitable precautions for prevention or remediation of those dangers. Our correlation and regression analyses revealed that most of the variation of knowledge concerning dangers and safety precautions is not explained by variation in the educational attainment and SES of the mothers. Future directions are explored.

Accident Prevention↗