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PubMed1979

A validation procedure for air sampling-analysis systems.

Validation of solid sorbent air sampling-analytical systems used to evaluate employee exposures to substances in the work place air is a fundamental part of any industrial hygiene air sampling program. In April, 1977, the National Institute for Occupational Safety and Health (NIOSH) published "Documentation of the NIOSH Validation tests", as part of the Standards Completion Project. This paper presents an alternative validation procedure which is more easily understood, is more rigorous, and provides for greater accuracy and precision.

Air Pollutants↗
PubMed1955

Experimental needle biopsy of the myocardium of dogs with particular reference to histologic study by electron microscopy.

Our experience with needle biopsy of the heart in dogs indicates that myocardial tissue can be sampled one or more times in each animal with comparative safety. Tamponade, pericarditis, serious arrhythmias, or myocardial infarction due to the interruption of coronary vessels was not observed. Excellent specimens were obtained for critical study by light and electron microscopy. Casten and Marsh (1) have used biochemical techniques to study myocardial tissue obtained in similar fashion. Histochemical methods would also be applicable. Although limited to animal studies at present, the technique may conceivably be adapted to the study of human disease. Myocardial puncture has been carried out (20-22) in patients for the recording of intracardiac pressures and for other diagnostic purposes without apparent harm. Our study of the myocardium of dogs by electron microscopy generally confirms the observations of other workers, except that presence of significant numbers of red blood cells in the extravascular spaces of the heart had not been previously described (and is possibly an artifact). Nevertheless, it is notable that the tissue cells, cellular membranes, and intracellular structures appeared to be intact and undistorted in the tissue specimens which were obtained, fixed, and examined by these methods.

Animals↗
PubMed1994

Co-culture with Vero cell monolayer maintains the motility of asthenozoospermic semen samples.

The clinical effectiveness of co-culture with Vero (Green monkey kidney) cell monolayer in maintaining the motility and viability of fresh asthenozoospermic semen (18 samples) and frozen-thawed semen with poor motility (motility fraction < 50%) (15 samples) in a 24-h period was evaluated. Co-culture with Vero cell monolayer in human tubal fluid (HTF) medium for 24 h resulted in a statistically better maintenance of motility percentage (P < 0.005), mean amplitude of lateral head displacement (ALH) (P < 0.005), and mean track speed (VCL) (P < 0.05) than culture in HTF medium alone. However, these motility parameters (motility percentage, ALH, VCL) declined soon after removal of spermatozoa from the monolayer. Co-culture with Vero cell monolayer also maintained the viability percentage of these sperm samples (52% of the original value) after the 24-h period compared with culture in HTF medium alone (22% of the original) (52% versus 22%, P < 0.05). It is concluded that Vero cell monolayer is effective in the maintenance of motility and viability of asthenozoospermic semen or frozen-thawed semen with poor motility. This co-culture system may be beneficial in enhancing the in-vitro performance of asthenozoospermic semen samples in the practice of assisted reproductive technology. However, its safety needs further evaluation.

Animals↗
PubMed2001

The efficacy and safety of risperidone for the treatment of geriatric psychosis.

Risperidone is an atypical antipsychotic drug which has been suggested to be beneficial for the treatment of elderly patients with psychotic symptoms. In this study, we assessed the short-term efficacy and the safety of risperidone in geropsychiatric inpatients with psychotic symptoms. The sample population included 110 elderly inpatients with psychotic disorders. Assessment for drug efficacy using the Brief Psychiatric Rating Scale, Sandoz Clinical Assessment-Geriatric scale, and Clinical Global Impression scale was conducted at baseline and also at 4 weeks subsequent to risperidone treatment commencement. Subsequent to commencing risperidone treatment, 80 patients completed a 4-week therapeutic evaluation. Seventy (87.5%) of the 80 patients experienced mild to substantial improvement using the Clinical Global Impression scale. Adverse effects were monitored in all 110 patients. The most commonly detected adverse effects were weakness of legs or walking problems (43/110; 39.1%) and dizziness (32/110; 29.1%). Peripheral edema was noted in 18 (16.4%) patients. Risperidone, in low doses, appeared to have been effective in this sample of patients older than 65 years with psychotic symptoms. The mean dose (2.1 +/- SD 1.4 mg/day) applied was lower then that suggested for young patients and was related to the each specific patient diagnosis. Peripheral edema and walking problems were commonly observed adverse effects for these elderly patients, such problems having not been seen to the same extent in previous studies of young patients.

Aged↗
PubMed2005

Pharmacokinetics of intravenously administered azithromycin in pediatric patients.

BACKGROUND: The objective of this study was to characterize the pharmacokinetics and tolerance of a single intravenous (IV) azithromycin dose in children. METHODS: Subjects were stratified into 4 age groups: 0.5-2 years; >2-<6 years; 6-<12 years; and 12-<16 years. Each subject received a single 10 mg/kg dose (500 mg maximum) infused in 1 hour. Serial venous blood samples were obtained for a 168-hour period, and laboratory safety evaluations were performed immediately preceding azithromycin administration and at the conclusion of the study. Serum azithromycin concentrations were quantified with a validated high performance liquid chromatography method with mass spectrometric detection. Pharmacokinetic indices were calculated for each subject by noncompartmental techniques. RESULTS: Thirty-two subjects (6.7 +/- 5.0 years, 11 boys) participated. Mean serum concentration-time data were comparable for the 4 age groups. For all subjects with evaluable data, the mean area under the curve from 0 to 72 hours (AUC0-72) was 8.2 microg . h/mL (n = 26), the maximum concentration (Cmax) was 2.4 microg/mL and the elimination half-life (t1/2) was 65.2 hours (n = 25). The AUC0-72 and Cmax were not associated with age. The dose was well-tolerated with no serious adverse events. CONCLUSION: The disposition of azithromycin after a single 10-mg/kg IV dose (maximum labeled adult dose of 500 mg) is comparable in pediatric patients between 0.5 and 16 years of age. These pharmacokinetic data can be used to guide dose selection for future therapeutic trials of IV azithromycin in pediatric patients.

Adolescent↗
PubMed2004

PCR assays for identification of Coccidioides posadasii based on the nucleotide sequence of the antigen 2/proline-rich antigen.

A conventional nested PCR and a real-time LightCycler PCR assay for detection of Coccidioides posadasii DNA were designed and tested in 120 clinical strains. These had been isolated from 114 patients within 10 years in Monterrey, Nuevo Leon, Mexico, known to be endemic for coccidioidomycosis. The gene encoding the specific antigen 2/proline-rich antigen (Ag2/PRA) was used as a target. All strains were correctly identified, whereas DNA from related members of the family Onygenaceae remained negative. Melting curve analysis by LightCycler and sequencing of the 526-bp product of the first PCR demonstrated either 100% identity to the GenBank sequence of the Silveira strain, now known to be C. posadasii (accession number AF013256), or a single silent mutation at position 1228. Length determination of two microsatellite-containing loci (GAC and 621) identified all 120 isolates as C. posadasii. Specific DNA was amplified by conventional nested PCR from three microscopically spherule-positive paraffin-embedded tissue samples, whereas 20 human tissue samples positive for other dimorphic fungi remained negative. Additionally, the safety of each step of a modified commercially available DNA extraction procedure was evaluated by using 10 strains. At least three steps of the protocol were demonstrated to sufficiently kill arthroconidia. This safe procedure is applicable to cultures and to clinical specimens.

Antigens, Fungal↗
PubMedDate not supplied

Cervical acid phosphatase: a biomarker of cervical dysplasia and a potential surrogate endpoint for colposcopy.

BACKGROUND: In 2000, cervical acid phosphatase (CAP) has been recently described as a biomarker labeling abnormal squamous cells on Pap smears (USPTO #6,143,512). The enzyme activity is presented as a red, granular deposit on a modified Papanicolaou background. This unique property was utilized for development of MarkPap technology intended for cervical cancer screening. MATERIAL/PATIENTS & METHODS: We conduct a multicenter, random assignment, assessor blinded, 2-group (test and control), split-sample designed clinical trial on 1,500 subject/specimens to assess safety and efficacy of the new test, in comparison with the control, for cervical cancer screening in standard Pap test environment. Safety is measured with frequency, severity and relation of adverse events. Efficacy is measured with primary endpoints (portion of positive/abnormal specimens detected, and the false negative rate). At the end of the follow-up period (two years) when the study will be completed, other efficacy endpoints such as accuracy (sensitivity/specificity) and predictive values will be added to the method evaluation. Here we present in interim analysis. RESULTS: In April 2003, the recruitment was completed and the first twelve hundred cases have been evaluated. There was no serious or related adverse event in both groups. Minor, unrelated adverse events were rare and insignificantly distributed in both groups. PRIMARY ENDPOINTS: A: Portion of positive/abnormal specimens detected: Pe (new test) = 0.166, Ps (Pap control): 0.082; Ps' (ACS reported value for US in year 2000): 0.07. Pe >/= Ps + delta, for delta = 0.5Ps. B. False negative rate: Pe = 0.05, Ps' = 0.10. Confidence intervals: 95% CI: Test [0.148-0.193], Pap control [0.068-0.098]. OR = 2.26. chi2 = 40.69101 is greater than the critical value of 3.841 (P < 0.01). CONCLUSION: We concluded that CAP had added to visibility of Pap test and has enabled cytoscreeners to significantly improve the detection of positive/abnormal specimens and reduce false negative rate. We discuss this unique property of CAP with emphasis on using it as a surrogate endpoint for colposcopy and eventual removal of a cervical lesion that, if untreated, could progress into cancer.

Acid Phosphatase↗
PubMedDate not supplied

Placing blood on the target: a challenge for visually impaired persons.

An individualized, blood glucose self-monitoring procedure for those who are visually impaired must be developed, taught, practiced, observed, and reviewed. Effective teaching requires understanding functional vision loss, observing safety precautions, organizing the work area, obtaining an adequate blood sample, ensuring accurate placement of blood on the strip, and cleaning up. Thoroughness and repetition enable the visually impaired person to perform the procedure safely and confidently.

Audiovisual Aids↗
PubMed1994

Treatment of infantile spasms.

OBJECTIVE: To summarize and evaluate the literature regarding the clinical features, epidemiology, etiology, pathophysiology, and treatment of infantile spasms. DATA SOURCES: A literature search of articles from January 1966 to July 1993 using MEDLINE, EM-Base, and Current Concepts/Life Sciences, as well as bibliographies of relevant articles. STUDY SELECTION: All identified original and review publications regarding the clinical features, epidemiology, etiology, pathophysiology, and treatment of infantile spasms were reviewed. Emphasis was placed on original studies published since 1975. DATA EXTRACTION: Data from published research were extracted and evaluated according to study design, sample size, dosing regimen, outcome measures, and treatment efficacy and safety. DATA SYNTHESIS: Infantile spasms constitute a rare epileptic syndrome with a poor long-term prognosis for normal intellectual development. The spasms are characterized by a brief symmetric contraction of the muscles of the neck, trunk, and/or extremities, often occurring in a series of 2 to more than 100 spasms during a single episode. The disorder is age-specific, with the peak onset of symptoms occurring between 2 and 8 months of age. Spasms of no identifiable cause in infants with normal development prior to the onset of infantile spasms are classified as cryptogenic or idiopathic, whereas those with an identifiable cause are classified as symptomatic. Long-term prognosis is best in cryptogenic cases, with 30-70 percent attaining normal intellect compared with 5-19 percent in symptomatic cases. The etiology and pathophysiology are not well understood. Recent theory postulates that infantile spasms may be caused by an excess of corticotropin-releasing hormone activity during infancy. The suspected association between the whole-cell pertussis vaccine and infantile spasms is coincidental. Few well-designed, prospective, controlled clinical trials for the treatment of infantile spasms have been conducted. CONCLUSIONS: Standard anticonvulsants such as phenytoin, the barbiturates, carbamazepine, and the succinimides have been ineffective. Of the anticonvulsants, only the benzodiazepines, valproic acid, and vigabatrin have shown efficacy in reducing spasm frequency and severity. Hormonal therapy with adrenocorticotropic hormone (ACTH) and/or prednisone has been the most frequently studied treatment modality and appears to be the most effective. Hormonal therapy achieves complete spasm control in 50-75 percent of infants within four weeks of initiation. Opinions differ regarding the relative efficacy between ACTH and prednisone, the need for early initiation of hormonal treatment, and the benefits of high dosages of ACTH (> 40 units/d). No treatment has been shown conclusively to improve the long-term intellectual development of these infants. Neurosurgery may be the treatment of choice in select cases when a localized central nervous system abnormality can be demonstrated. Well-designed, blind, prospective clinical trials are needed to answer definitively many lingering questions regarding the treatment of infantile spasms.

4-Aminobutyrate Transaminase↗
PubMed1999

Test of parenting skills.

An item pool was developed to assess basic parenting skills in the areas of attachment, emotional capacity, judgment, knowledge of child development, and safety. Initially, 200 items were generated and completed by a sample of 15 parents. Item scores correlated with scores on a social desirability scale or having low variance were edited or eliminated. A sample of 56 parents completed the revised scale, a social desirability scale, and the Adult-Adolescent Parenting Inventory. The reliabilities of the final subscales of the Test of Parenting Skills were modest, ranging from .56 to .77. Scores on the subscales were also correlated with those subscales from the Adult-Adolescent Parenting Inventory. With the exception of the Judgment scores being correlated with the use of harsh discipline, the significant correlations suggested concurrent validity. The individual subscales require additional refinement to achieve adequate internal consistency, but they have potential for measuring competency in core parenting skills.

Adolescent↗
PubMed1989

A retrospective study: osteoporosis and hormone replacement therapy.

The purpose of this study was to determine if women who undergo hormone replacement therapy postmenopausally, will demonstrate less osteoporosis than women who do not undergo HRT. The osteoporosis subjects were 195 women who volunteered to participate in an NIH-sponsored double-blind clinical trial entitled Safety and Efficacy of Fluoride Therapy in Osteoporosis. A convenience sample of 78 controls was obtained by inviting women seeking regular medical attention to join an epidemiological investigation of osteoporosis. The data were analyzed using Chi-square and Student's t-ratio. The study concludes that future retrospective and prospective analyses appreciate the complexity of the problem in terms of individual risk for osteoporosis.

Aged↗
PubMed1997

[The effect on bowel sounds of very hot compresses applied to the lumbar region].

In Japan, very hot moist compresses applied to the lumbar region have been used to promote intestinal movement and flatus or defecation. This skill was based on empirical knowledge. One of the purposes of this study is to make clear the effect of very hot compresses on intestinal movement. The other purpose is to prove the safety of the skin where very hot compresses applied. The sample consisted of 8 healthy female volunteers, ranging in age from 27 to 47 with a mean age of 37.4. A very hot compress was applied to the lumbar region for 10 minutes. The results were as follows: 1) Bowel sounds immediately after hot compresses increased 1.7 times compared with bowel sounds before the hot compresses. 2) Skin temperature of the back increased to 41.1-43.1 degrees centigrade under the hot compresses, then decreased rapidly. 3) Blood flow to the back during hot compresses, increased to 156%. Blood flow to the upper arm also increased. 4) Body temperature, pulse rate and blood pressure were not remarkably changed by the hot compresses. The results of the experiments show that very hot compresses applied to the lumbar region affect intestinal movement. And the results suggest that a very hot compress is a useful nursing skill to promote flatus or defecation.

Adult↗
PubMed2003

[Clinical application of presurgical embolization of meningiomas].

OBJECTIVE: To evaluate the clinical efficacy and safety of presurgical embolization of meningiomas. METHODS: Matched analysis of samples of embolized and nonembolized groups of meningiomas were observed for variables of clinical efficacy in estimated blood loss, number of transfusions and length of post-operative recovery. RESULTS: All mean value of variables of embolized group, were lower than that of non-embolized (estimated blood loss, 1402.97 +/- 1171.60 ml versus 1852.94 +/- 993.40 ml; number of transfusions, 1325.53 +/- 1040.15 ml versus 1747.06 +/- 959.24 ml; length of post surgical recovery, 30.18 +/- 20.24 days versus 33.29 +/- 27.54 days); however, only the estimated blood loss and number of transfusions-variables were significant. There were no major complications caused by the embolization procedure. CONCLUSION: Endovascular devascularization of meningiomas is beneficial for meningiomas because it diminishes the necessity of intra operative transfusion and decreases blood loss. Otherwise the embolization procedure is safe.

Adolescent↗
PubMed2006

Pharmacokinetics of meloxicam in rabbits after single and repeat oral dosing.

We evaluated the pharmacokinetic profile of meloxicam (0.3 and 1.5 mg/kg) given as single and repeated (once daily for 5 d) oral doses to female rabbits (n = 5/group) to define the optimal dose and dosing interval for clinical use. Clinical signs, body weight, and serum chemistry parameters (sodium, potassium, chloride, total protein, urea, creatinine, glucose, alkaline phosphatase, gamma glutamyl transferase, and alanine aminotransferase) were evaluated before and 5 d after dosing to monitor safety at the 2 dose levels in both studies. Plasma samples were collected serially, and concentrations were determined by high performance liquid chromatography. After single oral dosing at 0.3 or 1.5 mg/kg, maximal plasma concentrations of meloxicam were achieved at 6 to 8 h and were 0.14 and 0.3 microg/ml, respectively. Plasma drug levels decreased rapidly to near-undetectable levels by 24 h. There was moderate interindividual variability in plasma meloxicam concentrations with less than proportional increases in peak plasma concentration and area under the concentration curve values at the higher dose after the single and repeat dosing. The elimination half-life was approximately 8 h at both dose levels, suggesting that metabolism was not saturated. Oral clearance of meloxicam is high in rabbits, indicating rapid metabolism and elimination. There was no accumulation of meloxicam when given at 0.3 or 1.5 mg/kg for 5 d, and meloxicam was rapidly eliminated after discontinuation of dosing. Rabbits may require a dose exceeding 0.3 mg/kg given once daily to achieve optimal plasma levels of meloxicam over a 24-h interval.

Animals↗
PubMed2006

Safety, biodistribution, and dosimetry of 123I-IMPY: a novel amyloid plaque-imaging agent for the diagnosis of Alzheimer's disease.

UNLABELLED: (123)I-IMPY (6-iodo-2-(4'-dimethylamino-)phenyl-imidazo[1,2-a]pyridine) is a novel radiopharmaceutical that selectively binds to Alzheimer's disease (AD) amyloid plaques. As a first step toward validating this radiopharmaceutical as an imaging biomarker for AD, we measured the whole-body biokinetics and radiation dosimetry of (123)I-IMPY in AD patients and cognitively normal control subjects. The pharmacologic safety profile of the compound was simultaneously assessed. METHODS: The sample included 9 subjects ranging in age from 44 to 80 y. Whole-body images were obtained for each subject (mean +/- SD, 9.0 +/- 3.2 scans per subject) for up to 48 h after the intravenous administration of 185 MBq (5 mCi) of (123)I-IMPY. The fraction of administered activity in 12 regions of interest was quantified from the attenuation-corrected geometric mean counts in conjugate views. Multiexponential functions were iteratively fit to each time-activity curve using a nonlinear, least-squares regression algorithm. These curves were numerically integrated to yield cumulated activity values for source organs. Radiation doses were then estimated with the MIRD technique. RESULTS: The radiotracer had no pharmacologic effects (produced no changes in heart rate, blood pressure, or laboratory results) on any of the subjects. Radiation dosimetry estimates indicated that the dose-limiting organ was the gallbladder, which received an average of 0.135 mGy/MBq (range, 0.075-0.198 mGy/MBq). The effective dose equivalent and effective dose for (123)I-IMPY were 0.042 +/- 0.003 mSv/MBq and 0.035 +/- 0.001 mSv/MBq, respectively. The mean effective dose for (123)I-IMPY was similar to that for (111)In-diethylenetriaminepentaacetic acid (0.035 mGy/MBq), less than half that for (111)In-pentetreotide (0.81 mGy/MBq), and approximately twice that for (123)I-IMP (0.018 mGy/MBq). No significant differences were found between men and women or between AD patients and control subjects. CONCLUSION: (123)I-IMPY may be a safe radiotracer with appropriate biokinetics for imaging amyloid plaques in AD patients.

Adult↗
PubMed2006

Second-trimester pregnancy interruption with vaginal misoprostol in women with previous cesarean section.

OBJECTIVE: To describe the experience of misoprostol use for pregnancy interruption in the second trimester of women with previous cesarean section. MATERIAL AND METHOD: Seventeen pregnant women with viable fetuses and with previous cesarean section indicated for second trimester pregnancy interruption attending Maharaj Nakorn Chiang Mai Hospital were recruited. All received the same regimen of 400 mcg intravaginal misoprostol every 6 hours. The data was analyzed for demographic characteristics, the adverse outcomes, success rate, and time interval to fetal expulsion. RESULTS: The incidences of adverse outcomes were as follows, fever (47.1%), chill (23.5%), and nausea (17.6%). No uterine rupture occurred in this series at all. The rate of oxytocin use and analgesia requirement was 29.4%. Success rate of pregnancy interruption was 100%, though two of them had an abortion time of more than 48 hours. Time interval from misoprostol administration to fetal expulsion was 25.9 +/- 34. 1 hours (range 4.0-142.7 hours). CONCLUSION: This case series reaffirms the efficacy of misoprostol and suggests that misoprostol may relatively be safe even in cases with previous cesarean section. Therefore, misoprostol may be an option of pregnancy interruption in the second trimester to avoid unnecessary surgical procedure including hysterotomy. However, the safety should be tested by further studies with a larger sample size.

Abortifacient Agents, Nonsteroidal↗
PubMedDate not supplied

Determination of pentachlorophenol in animal tissues: a Canadian perspective.

Analytical methods for pentachlorophenol (PCP) residues in edible animal tissue have been reviewed, with particular reference to gas chromatographic methods of analysis. Results of analyses demonstrate that significant residues of PCP can persist for several weeks in animals exposed to contaminated bedding. National surveys in Canada have found that the incidence of PCP residues in pork in excess of 0.1 ppm was reduced from 32% of survey samples in 1981-1982 to 6.6% of samples tested in 1987-1988. An interlaboratory sample exchange among Canadian laboratories demonstrated that the PCP analytical method currently used by Agriculture Canada could be successfully transferred to other laboratories. An exchange of samples between regulatory laboratories of Agriculture Canada and the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) demonstrated equivalency of results for the 2 methods currently used in the respective laboratories, with relative standard deviations for analytical results ranging from 4.4 to 22.2%.

Animals↗
PubMed1989

[Choriocentesis: comparison of the effectiveness of a new choriocentesis needle and a transcervical biopsy forceps].

71 samples taken by the transabdominal route were compared with 71 samples taken by forceps through the cervix. A fine (1 mm) transabdominal choriocentesis needle with a thin wall (0.1 mm), a short bevel, and a lateral hole was made to bring together simplicity, effectiveness and safety; success was obtained in 95% of the cases (39/41) of our last 41 samples on the first attempt. For comparison with the forceps, the success rate on the first attempt was only 66% (26/41), but it rose to 97.5% if the patient could take 3 attempts at most. The forceps made it possible to collect a mean quantity large enough (19.9 mg) but it was quite variable (16.7 mg being the range) of complete villi, whereas the choriocentesis needle only gathered a smaller volume (12.7 mg) but more reliable (the range being 3.7 mg). The villi were fragmented, however. To work out the study of the DNA and the karyotype, there is a choice between the forceps and the needle. This choice depends principally on the damage the two techniques can do. This has not been worked out yet in our study except indirectly.

Biopsy↗