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At least 469 records · Page 26Linked to original sources
PubMed2002

Influence of lower extremity strength of healthy older adults on the outcome of an induced trip.

OBJECTIVES: To determine whether decreased lower extremity strength contributes to trip-related falls in older adults. DESIGN: A cross-sectional sample of older adults were safety-harnessed and tripped while walking using a concealed, mechanical obstacle. Lower extremity strength was compared between trip outcome groups. SETTING: A biomechanics research laboratory. PARTICIPANTS: Seventy-nine healthy, community-dwelling adults aged 65 and older (50 women). MEASUREMENTS: Ankle, knee, and hip flexion and extension strength were measured isometrically and isokinetically. Measured strengths were subjected to a factor analysis. Strength factor scores were compared between those who recovered from the trip and those who fell by three previously identified mechanisms: during-step, after-step, and elevating-response falls. RESULTS: Seven common factors, one associated with each direction of exertion at each joint and one with the time rate of moment increase, explained 88% of the variance in measured strength. The during-step (n=5) fallers were significantly stronger in the ankle extension (plantarflexion), knee flexion, overall extension, and total strength factors than those who successfully recovered using a similar, lowering strategy (n=26). The elevating-response faller (n=1) was stronger in the plantarflexion and overall extension factors than most of those who recovered using a similar, elevating strategy (n=11). Two of three after-step fallers were among the weakest subjects tested. CONCLUSION: Weak older adults and the strongest older adults may be at greater risk of falling from a trip, although by different mechanisms. High strength may increase the likelihood of a during-step or elevating-response fall; decreased strength may increase the likelihood of an after-step fall.

Accidental Falls↗
PubMed2006

Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine.

BACKGROUND: Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed. METHODS: We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition. RESULTS: Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients. CONCLUSIONS: A two-dose regimen of 90 mug of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986.).

Adolescent↗
PubMed2000

Pharmacokinetic interaction between verapamil and almotriptan in healthy volunteers.

OBJECTIVE: To assess the interaction between almotriptan, a 5-HT1B/1D-receptor agonist used to treat migraine, and verapamil, an agent for migraine prophylaxis. METHODS: Twelve healthy volunteers received the following treatments in a crossover design: (1) 120-mg sustained-release verapamil tablet twice daily for 7 days and one 12.5-mg almotriptan tablet on day 7 and (2) one 12.5-mg almotriptan tablet alone on day 7. Serial plasma and urine samples were obtained on day 7. Almotriptan plasma concentrations were determined by liquid chromatography-tandem mass spectrometry; urine samples were analyzed by ultraviolet HPLC. Safety measures included blood pressure and pulse measurements, electrocardiography, and adverse event monitoring. Statistical comparisons of pharmacokinetic parameters and vital sign data were made by ANOVA. RESULTS: Mean almotriptan peak concentration and area under the plasma concentration-time curve were significantly higher and volume of distribution and oral clearance were significantly lower after coadministration of almotriptan and verapamil compared with administration of almotriptan alone. The magnitudes of these differences were approximately 20%. Renal clearance was unaffected by verapamil coadministration. No significant effects of treatment on blood pressure or pulse were detected, with the exception of sitting systolic blood pressure at 2 hours after administration. However, the difference in mean change from baseline at this time point was only 8 mm Hg. CONCLUSIONS: Verapamil modestly inhibited almotriptan clearance to a degree consistent with the modest contribution of CYP3A4 to almotriptan metabolism. This observation and the lack of effect of verapamil on the tolerability to almotriptan administration suggest that no reduction of the almotriptan dose is warranted.

Adolescent↗
PubMed2001

Effect of gestational zinc deficiency on pregnancy outcomes: summary of observation studies and zinc supplementation trials.

The lack of a valid indicator precludes a true estimate of zinc deficiency in pregnancy in various populations. However, it is possible that mild to moderate deficiency (as assessed by available indicators) may be common in the developing world. Animal experiments indicate that zinc deficiency can result in adverse maternal and fetal consequences. Human data, particularly from prenatal zinc supplementation trials, has failed to document a consistent maternal or infant benefit on evaluated outcome measures including pregnancy induced hypertension, preterm/post-term labour, premature rupture of membranes, maternal infection, postpartum haemorrhage, perinatal mortality, congenital malformations and fetal growth and gestation. Preliminary data suggest a beneficial effect of prenatal zinc supplementation on infants' neurobehavioural development and immune function (evaluated by diarrhoeal and ARI morbidity incidence in the first year of life). Future research should focus on these functional consequences and congenital malformations (with adequate sample sizes), and simultaneously address the safety issue, particularly in relation to micronutrient interactions. In the light of the currently available information, routine zinc supplementation can not be advocated to improve pregnancy outcome.

Animals↗
PubMedDate not supplied

Dust exposures at U.S. surface coal mines in 1982-1983.

Exposures to British Mining Research Establishment corrected respirable dust and respirable quartz at U.S. surface coal mines during 1982-1983 were evaluated from coal mine operator and Mine Safety and Health Administration (MSHA) inspector samples. The average respirable quartz concentration from inspector samples ranged from .34-.49 mg/m3 for drilling jobs and .18 mg/m3 for bulldozer operators. For most other surface coal mine jobs, the average respirable quartz concentration was less than .1 mg/m3, and the average respirable dust concentration was less than 2 mg/m3. The results from the analysis of quartz exposures are consistent with epidemiological results for an increased silicosis risk among drillers. It is unclear, however, whether the MSHA samples provide a representative estimate of the average annual quartz concentration for drillers. Results suggest the need for a greater number of quartz samples to be taken on strip coal miners, particularly on drillers and bulldozer operators.

Air Pollutants, Occupational↗
PubMed1998

The Pipelle endometrial suction curette: how useful is it in clinical practice?

The Pipelle endometrial sampler is gaining popularity as an alternative to formal dilatation and curettage (D&C). This study demonstrates that the Pipelle reduces the number of D&Cs required to assess the endometrium by 65%. This has significant benefits in terms of patient safety and cost. If an inadequate sample is obtained, which occurs most commonly in the postmenopausal patient, there may be a temptation to ascribe this to the presence of an atrophic endometrium. This study, however, finds a significant chance of an underlying carcinoma in these cases. Thus whereas the Pipelle sampler has clinical usefulness when a sample sufficient for histological analysis is obtained, an equivocal result must lead to further investigation.

Journal Article↗
PubMed1990

Perchloroethylene exposure assessment among dry cleaning workers.

Perchloroethylene (Perc), the most widely used solvent in dry cleaning, is toxic to the liver, kidneys, and central nervous system and may be a human carcinogen. In the Detroit area, as part of a project investigating the health status of dry cleaning workers, an exposure assessment was carried out in dry cleaning plants using perchloroethylene. Breath samples were obtained from each participant, and time-weighted average (TWA) breathing zone air samples were obtained using passive dosimeters on a subset expected to experience a range of exposures. Perc in breath and Perc in air were highly correlated (r2 = 0.75, p less than 0.0001). On average, operators of dry cleaning equipment experienced significantly more exposure than nonoperators. Also, employees working in shops that use transfer equipment (requiring physical transfer of Perc-saturated clothing from washers to dryers) showed significantly higher exposure than those in shops utilizing dry-to-dry machinery (permitting washing and drying in one machine in a single cycle). One or more air samples in every transfer shop exceeded the recently revised Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) of 25 ppm, while no air samples in dry-to-dry shops exceeded this limit. The results suggest concern for exposures to operators in transfer shops and that compliance with the PEL is achievable by engineering controls with presently existing technology.

Adult↗
PubMedDate not supplied

Perspectives on the use of the baboon in embryology and teratology research.

This paper summarizes the developmental stages of the baboon during the period of organ formation and provides comparative information for other primates, including the human. Special attention is directed to the early development of the nervous system, eye, ear and nose/palate. The similarity in development of these structures with humans indicates that the baboon is a suitable model for studies of normal and abnormal neurological development. Spontaneous prenatal loss rates in the baboon (2.4-11.2%) are slightly lower than those reported in rhesus and cynomologus monkeys. The baboon, in addition to the cynomologus monkey and macaque, has been used as a model in teratology research to assess the potential risk of thalidomide, sex steroids, Bendectin and rubella virus, as well as to study the pathogenesis of malformations associated with the corticosteroid triamcinolone acetonide. The rate of spontaneous malformations (<1%) in baboons, similar to that reported for other commonly used primates, supports their continued use as a teratological model. In this regard, a sample protocol is provided for the safety evaluation of biotechnology products using nonhuman primates, which are the most appropriate model for those compounds which are bioactive in species closely related to humans.

Abnormalities, Drug-Induced↗
PubMed1990

Double-blind comparison of pefloxacin and cefazolin as prophylaxis in elective cardiovascular surgery.

A total of 162 patients (134 males and 28 females) scheduled for coronary artery bypass grafting (144) or valve surgery (18) were randomly assigned to receive, under double-blind conditions, either pefloxacin 400 mg iv or cefazolin 1.0 g 30 min before the surgical incision and then post-operatively 12-hourly x 4 or 6-hourly x 8, respectively. Positive per- and post-operative cultures were seen in 27 patients (11 pefloxacin, 16 cefazolin) and 47 micro-organisms were isolated: 34 per-operatively (21 pefloxacin, 13 cefazolin) and 13 post-operatively (4 pefloxacin, 9 cefazolin). There were five failures of prophylaxis (2 pefloxacin, 3 cefazolin): two early (less than 5 days: 1 pefloxacin, 1 cefazolin) and three late (greater than or equal to 5 days, 1 pefloxacin, 2 cefazolin) divided into (i) one major primary failure in the cefazolin group (1 cefazolin resistant Staphylococcus epidermidis mediastinitis); (ii) two minor primary failures, one in each group (Gram-positive sternal incision abscesses) and (iii) two secondary failures (1 cefazolin resistant Enterobacter cloacae and Pseudomonas aeruginosa UTI in the cefazolin group and one culture negative pneumonia in the pefloxacin group). Tolerance to both antibiotics was excellent. In our sample of patients, the efficacy and safety of pefloxacin was not different from those of cefazolin in prophylaxis in cardiovascular surgery.

Aged↗
PubMed2001

Radiation protection at low energy proton accelerators.

A sample is provided of the radiological safety issues particular to low energy proton accelerators. 'Low' energy in this context is taken to mean proton energies of less than about 1 GeV. Many of the radiation issues are common to all particle accelerators. Here, those issues are addressed that may require perhaps not unique treatment but those which benefit from a different approach. Among the problems discussed are the generation of prompt radiation and its transmission through shielding, the estimation of induced radioactivity, and the assessments of both the off-site prompt radiation hazard and the effect of releases of radioactive effluents to the environment.

Dose-Response Relationship, Radiation↗
PubMed1997

A proposed method to minimize waste from institutional radiation safety surveillance programs through the application of expected value statistics.

Institutional radiation safety programs routinely use wipe test sampling and liquid scintillation counting analysis to indicate the presence of removable radioactive contamination. Significant volumes of liquid waste can be generated by such surveillance activities, and the subsequent disposal of these materials can sometimes be difficult and costly. In settings where large numbers of negative results are regularly obtained, the limited grouping of samples for analysis based on expected value statistical techniques is possible. To demonstrate the plausibility of the approach, single wipe samples exposed to varying amounts of contamination were analyzed concurrently with nine non-contaminated samples. Although the sample grouping inevitably leads to increased quenching with liquid scintillation counting systems, the effect did not impact the ability to detect removable contamination in amounts well below recommended action levels. Opportunities to further improve this cost effective semi-quantitative screening procedure are described, including improvements in sample collection procedures, enhancing sample-counting media contact through mixing and extending elution periods, increasing sample counting times, and adjusting institutional action levels.

Radiation Monitoring↗
PubMed1995

Separation and concentration of bacteria with immobilized antibody fragments.

New methods to quantitatively remove bacteria from food and water samples are required to meet modern safety standards. The recent development of techniques to make Fab/Fv/scFv fragments in bacteria has provided the opportunity to exploit antibodies as specialized chemicals for affinity removal technologies. Single-chain fragments against Pseudomonas aeruginosa have been expressed in Escherichia coli, purified via a fused poly-histidine tail and immobilized upon polystyrene beads. The resulting immunoaffinity columns have been shown to effectively remove greater than 90% of an applied 10 million bacteria after a single passage through the column. Column material in the absence of single-chain retained less than 10% of the bacteria. Pseudomonas were also removed from milk, mixed bacterial cultures and when present at low cell densities.

Antibodies, Bacterial↗
PubMedDate not supplied

Varicella in pediatric patients.

OBJECTIVE: To summarize the literature describing the epidemiology, transmission, clinical manifestations, diagnosis, treatment, and prevention of varicella in the pediatric population. DATA SOURCES: A literature search of English-language articles from 1982 to 1992 using MEDLINE and bibliographies of relevant articles. The search term used was varicella. STUDY SELECTION: All review articles and original studies addressing the epidemiology, transmission, clinical manifestations, complications, diagnosis, treatment, and prevention of varicella in pediatric patients were reviewed. Emphasis was placed on controlled studies done in the US. DATA EXTRACTION: Data from human studies were extracted by the authors and evaluated according to patient population, sample size, dosing regimen, efficacy, and safety. DATA SYNTHESIS: Varicella-zoster virus is a highly contagious virus that produces a common and costly disease in the pediatric population. The primary manifestation of varicella is the eruption of vesicular lesions. In most cases varicella is benign, but it can be associated with serious complications. Diagnosis is based primarily on clinical findings. Otherwise healthy children have traditionally received only symptomatic treatment for varicella, but recent literature suggests that antiviral therapy may be useful in these patients. Immunocompromised patients benefit from both symptomatic and antiviral therapy. Isolation and varicella-zoster immune globulin are used to prevent varicella. In the future, varicella vaccine will play an important role in preventing the disease. Varicella vaccine has been shown to be immunogenic and clinically effective in both healthy and immunocompromised children. Adverse reactions associated with the vaccine include fever, injection-site reactions, and rash. Although zoster can follow vaccination, the incidence appears to be lower in vaccinated individuals. Preliminary studies have shown that the vaccine provides protection from varicella-zoster virus for an extended period of time. CONCLUSIONS: Varicella is a common, usually benign disease of childhood. All patients may benefit from symptomatic therapy. Current literature does not support the use of antiviral therapy in all pediatric patients with varicella. When commercially available, varicella vaccine will play an important role in prevention. Long-term studies are needed to fully assess the risk of developing varicella and zoster following vaccination.

Acyclovir↗
PubMed1994

Lead poisoning from paint--still a potential problem.

Regulations were introduced in the UK in the 1970s to limit the lead content of paints. This has greatly reduced the number of children poisoned by ingesting leaded paint. However, it is argued that old paintwork is still a lead poisoning hazard in some older UK properties. Paint collected from a children's nursery classroom in a London school included samples with lead concentrations exceeding suggested safety levels. Lead poisoning from paint is a problem which should not be forgotten in the UK, and may be a more serious problem in countries with less stringent lead in paint regulations.

Child↗
PubMed2006

Phase II trial of a toll-like receptor 9-activating oligonucleotide in patients with metastatic melanoma.

PURPOSE: The recent identification of toll-like receptors (TLRs) and respective ligands allows the evaluation of novel dendritic cell (DC) -activating strategies. Stimulation of TLR9 directly activates human plasmacytoid DCs (PDCs) and indirectly induces potent innate immune responses in preclinical tumor models. We performed an open-label, multicenter, single-arm, phase II pilot trial with a TLR9-stimulating oligodeoxynucleotide in melanoma patients. PATIENTS AND METHODS: Patients with unresectable stage IIIb/c or stage IV melanoma received 6 mg PF-3512676 weekly by subcutaneous injection for 24 weeks or until disease progression to evaluate safety as well as clinical and immunologic activity. Clinical and laboratory safety assessments were performed weekly; blood samples for immunological measurements were taken every 8 weeks. Tumor measurements were performed according to Response Evaluation Criteria in Solid Tumors. RESULTS: Twenty patients received PF-3512676 for a mean of 10.9 weeks with a mean of 10.7 injections. Laboratory and nonlaboratory adverse events were limited, transient, and did not result in any withdrawals. Two patients experienced a confirmed partial response; one response is ongoing for 140+ weeks. Three patients experienced stable disease. Immunologic measurements revealed induction of an activated phenotype of PDC, elevation of serum levels of 2',5'-oligoadenylate, a surrogate marker of type I interferon production, and significant stimulation of natural killer cell cytotoxicity (the latter was associated with clinical benefit). CONCLUSION: These results indicate that TLR9-targeted therapy can stimulate innate immune responses in cancer patients, identify biomarkers that may be associated with TLR9-induced tumor regression, and encourage the design of follow-up studies to evaluate the ability of this therapeutic approach to target human cancer.

Adult↗
PubMedDate not supplied

Quantification of ecdysteroids by immunoassay: comparison of enzyme immunoassay and radioimmunoassay.

The performance of enzyme immunoassay (EIA) and radioimmunoassay (RIA) in the quantitative analysis of ecdysteroids was compared. The EIA was found to be at least equivalent to the RIA with respect to analytical range and sensitivity and to be more comfortable with respect to safety and time saving. When biological samples were analyzed by both assays a good correlation (r = 0.83) was found. Since the EIA has certain advantages over the RIA, we now recommend the use of the former assay for the quantification of ecdysteroids.

Animals↗
PubMedDate not supplied

Low frequency of side effects following an incidental 25 times concentrated dose of yellow fever vaccine.

In August/1999, a group of 14 adults from the staff of a private hospital in Contagem - Minas Gerais State, Brazil, received unintentionally a 25 times concentrated dose of the 17-DD yellow fever vaccine (Bio-Manguinhos), due to a mistake at the reconstitution step. All patients were clinically and laboratorially evaluated at days 5, 13 and 35 post vaccination. Frequency of side effects and clinical observations of this group of individuals were not different from the observed in recipients immunized with normal doses of the vaccine. At the second and third evaluation none of the subjects reported symptoms. None of the patients presented abnormalities at the physical examination at none of the time points and in all cases the blood examination was normal, except for a reduced number of platelets that was detected in one subject at the first and second evaluation and reverted to normal at third evaluation. At the first evaluation point, 8 subjects were serum negative and 6 serum positive for yellow fever at the plaque reduction neutralization test. In 5 subjects the observed titre was 10 times higher as the baseline of 2.36 Log10 mUI/ml. The samples collected at second and third evaluation (13th and 35th days) demonstrated that all subjects responded to the vaccination with the exception of one that did not present a positive result in any of the samples collected. This evaluation confirms the safety of the 17-DD yellow fever vaccine.

Adult↗
PubMed2006

A novel antiretroviral class (fusion inhibitors) in the management of HIV infection. Present features and future perspectives of enfuvirtide (T-20).

Enfuvirtide (Fuzeon, Roche), is the first member of a novel class of antiretroviral agents, the so-called fusion inhibitors, which act against HIV with a completely novel (extra cellular) mechanism of action, and can therefore be easily added to all anti-HIV association therapies including all other antiretroviral agents belonging to nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors, since no interactions of any type are expected with enfuvirtide. Despite the need of a twice-daily parenteral (subcutaneous) delivery due to the polypeptide structure of the drug, and its proportionally short elimination lifetime, two extensive multicentre randomized clinical trials and a huge amount of other clinical and laboratory experiences confirmed the elevated potency and the safety profile of enfuvirtide in appropriate samples of HIV-infected patients (both adults and children), who failed and/or became intolerant to all previously available anti-HIV regimens, and had a very restricted choice of antiviral compounds showing residual activity. As a consequence, enfuvirtide is recommended as an adjunct to an "optimized background" containing at least one or two antiretroviral drugs, which are still active against the isolated viral strain, as assessed by resistance testing. The extremely promising profile of this novel anti-HIV drug and the reduced potential for the development of viral resistance (with no possibility of cross-resistance with the other anti-HIV classes) however warrant further pharmacokinetic, pharmacodynamic, pharmacogenomic, and pharmacoeconomic investigation. Also more extensive and prolonged clinical and quality of life studies are strongly needed to establish the best positioning of enfuvirtide in the current therapeutic guidelines of HIV disease and its future role, besides its current approval for salvage therapy of adult and pediatric HIV-infected patients with limited therapeutic options.

Adult↗