Public health nutrition practice in the United States.
Explore the source record for details and available documents.
Demography↗
Biomedical subjects
C Gleason
Publications and source records attributed to C Gleason.
Effects of age, gender, and diurnal variation on the steady-state pharmacokinetics of BMS-181101, an antidepressant, in healthy subjects.
OBJECTIVES: To investigate the effects of age, gender, and diurnal variation on the safety, tolerability, and steady-state pharmacokinetics of BMS-181101, an antidepressant, in humans. METHODS: This was a multiple-dose parallel-design study in 51 healthy subjects (12 young and 12 elderly men and 12 young and 15 elderly women). Each subject received a 15 mg oral dose of BMS-181101 every 12 hours on days 1 through 6 and one dose on day 7. After the evening dose on day 6 and morning dose on day 7, serial blood samples were collected at specified times after administration. Plasma was analyzed for BMS-181101 with use of an HPLC method. RESULTS: Male subjects tolerated BMS-181101 better than female subjects. The mean values for area under the plasma concentration-time curve over the dosing interval tau (AUC tau; 58.8 to 102.4 ng.hr/ml) and elimination half-life t1/2; 5.7 to 10.4 hours) for the elderly subjects were significantly greater than those for the young subjects (39.0 to 64.3 ng.hr/ml and 3.2 to 4.5 hours). The mean values for peak plasma concentration (Cmax; 14.7 to 25.2 ng/ml) and AUC tau (52.4 to 102.4 ng.hr/ml) for the women were significantly greater than those for the men (9.08 to 15.3 ng/ml and 39.0 to 73.6 ng.hr/ml). The mean values for Cmax (14.7 to 25.2 ng/ml) and AUC tau (54.8 to 102.4 ng.hr/ml) on the morning of day 7 were significantly greater than those after the evening dose on day 6 (9.08 to 17.3 ng/ml; 39.0 to 83.4 ng.hr/ml). CONCLUSIONS: An initial lower dose or appropriate titration of daily doses of BMS-181101 may be necessary for the treatment of elderly and female subjects, and the pharmacokinetics of BMS-181101 exhibited significant diurnal effects.
Adult↗
Development of an equilibrium immunoassay using electrochemiluminescent detection for a novel recombinant protein product and its application to pre-clinical product development.
In order for a biotechnology derived protein product to be considered 'well characterized', a thorough understanding of the pharmacokinetic and metabolic fate of the product is essential. Specifications for such products need to be based on historical data obtained in the pre-clinical, clinical and manufacturing experience through the use of specific, accurate, precise and validated assays. Typically, assays such as ELISA or RIA that have the disadvantages of limited dynamic range, matrix interactions and hazardous waste generation are used to gather this data. We present data in this abstract that demonstrates the utility of an equilibrium immunoassay that uses electrochemiluminescent detection in the assessment of the pharmacokinetic and metabolic fate of a biotechnology derived product based on either the human (AMG1h) or murine (AMG1m) protein sequence. The assay uses biotinylated antibody in a sandwich format with antibody labeled with the N-hydroxysuccinimide ester of a ruthenium (II) tris-bipyridine chelate for detection in the Origen System. Streptavidin-coated paramagnetic beads are used to capture the antibody-antigen-antibody sandwich complex and facilitate electrochemiluminescent detection. The assay standard curve for AMG1h ranges from a lower limit of quantitation (LOQ) of 2.5 ng ml(-1) to an upper limit of quantitation (ULQ) of 2000 ng ml(-1) with accuracy and precision of not greater then 15% CV and deviation from nominal over the range. The corresponding LOQ (0.5 ng ml(-1)) and ULQ (200 ng ml(-1)) values determined for AMG1m displayed similar accuracy and precision. In addition, we demonstrate that the assay as performed is insensitive to matrix effect up to addition of 7%, of the total reaction volume. General guidelines for developing similar electrochemiluminescent based assays and their applications, advantages and limitations will be discussed.
2,2'-Dipyridyl↗
Possible antioxidant effect of vitamin A supplementation in premature infants.
BACKGROUND: Increased lipid peroxidation caused by oxygen free radicals is thought to be one of the common pathogenetic mechanisms for the so-called oxygen radical diseases of prematurity. Since in vitro studies have shown that various forms of vitamin A can exert antioxidant effects that are more potent than those of vitamin E (treatment with which has been ineffective in these diseases), the purpose of this prospective, controlled study was to determine whether administration of supplemental vitamin A to premature infants deficient in this vitamin would have an antioxidant effect in vivo. METHODS: Fourteen infants (1181 +/- 35 g; gestational age 29 +/- 0.04 weeks) with a serum retinol concentration at 7 +/- 2 days of age in the deficient range, lower than 0.7 mumol/l (< 20 micrograms/dl), were enrolled in the study. Infants were randomized to receive the standard amount of vitamin A or standard plus supplemental (2.6 mumol/l [2500 IU] orally each day) vitamin A, beginning at 1 week of age. Antioxidant effects of supplementation were assessed by a decrease in lipid peroxidation, quantified by the ethane content of expired air. RESULTS: Three weeks after study enrollment, total daily vitamin A intake in the infants receiving supplements was 4.565 +/- 0.236 mumol (4354 +/- 225 IU) versus 1.879 +/- 0.317 mumol/l (1792 +/- 302 IU) in infants receiving standard amounts of the vitamin. In spite of the difference in intake of vitamin A, 3 weeks after study enrollment, serum retinol concentrations did not differ between the infants given supplements and those receiving standard amounts of vitamin A, 0.70 +/- 0.21 versus 0.66 +/- 0.07 mumol/l (20 +/- 6 micrograms/dl versus 19 +/- 2 micrograms/dl, respectively). In the infants receiving supplemental vitamin A, breath ethane values declined from baseline values. There was an inverse correlation between the number of weeks of supplementation and breath ethane values, whereas there was no significant correlation between the duration of the study and breath ethane values in the infants not given supplements. CONCLUSIONS: Our data suggest that supplementation with vitamin A in a small group of vitamin A-deficient preterm infants was associated with an antioxidant effect. Although no immediate clinical benefits were associated with supplementation, the data provide the rationale for future investigations of possible antioxidant effects of (larger amounts?) of vitamin A in higher risk premature infants born with subnormal serum retinol concentrations.
Administration, Oral↗
Pneumocandins from Zalerion arboricola. I. Discovery and isolation.
HPLC bioautography of the directed biosynthesis of Zalerion arboricola led to the discovery of pneumocandin B0 (L-688,786), a new antifungal and anti-Pneumocystis carinii lipopeptide. Isolation techniques were developed to separate this component from pneumocandin A0 (L-671,329) in fermentations of a mutant of Zalerion arboricola. A number of related compounds were also isolated, which differ from pneumocandins A0 and B0 in the hydroxylation patterns on the ornithine, homotyrosine, and proline.
Anti-Bacterial Agents↗
Efficacy and pharmacokinetics of intravenous immune globulin administration to high-risk neonates.
UNLABELLED: OBJECTIVE--To determine whether intravenous immune globulin (IVIG) administration modifies the incidence of infections in high-risk neonates. DESIGN--Randomized, double-blind study. SETTING--Neonatal intensive care unit at a tertiary care center. PARTICIPANTS: A total of 170 infants were enrolled, 82 of whom received IVIG and 88 of whom received the placebo preparation. Infants were stratified by birth weight into one of three groups (category 1, those weighing less than 1000 g; category 2, those weighing between 1000 and 1500 g; and category 3, those weighing more than 1500 g). INTERVENTIONS--Intravenous immune globulin (750 mg/kg of body weight), or albumin placebo was administered within 72 hours of admission to the tertiary care center and every 14 days thereafter until discharge from the neonatal intensive care unit or age 3 months. Serum IgG levels were measured and data collected relating to the incidence of systemic and localized infections and to the course of hospitalization. MEASUREMENTS AND MAIN RESULTS--The administration of IVIG had no major side effects and resulted in higher serum IgG levels in infants in all birth weight categories compared with infants receiving the placebo. Systemic infections developed in five IVIG-treated infants and five placebo-treated infants. Administration of immunoglobulin had no significant effect on the rate of localized infections or necrotizing enterocolitis. It also did not affect hospital course of the infants as measured by length of hospitalization or the number of days on assisted ventilation, supplemental oxygen, or antibiotics was required. CONCLUSIONS--The general administration of IVIG using this dosage regimen has limited effects on the clinical course of infants in a neonatal intensive care unit.
Bacteremia↗
Dental care, for disabled adults.
Explore the source record for details and available documents.
Adult↗
Sleep disturbance produced by electrical stimulation of the locus coeruleus in a human subject.
A 25-year-old man with a chronically implanted stimulating electrode placed in the region of the locus coeruleus (LC) was monitored for 5 nights in a sleep laboratory to study the role of the LC in sleep. Sleep patterns were compared between the 2 nights in which the stimulation was applied periodically every 90 min and the 2 nights in which no stimulation was applied. In contrast to the normal sleep patterns that occurred during the 2 nonstimulation nights, electrical stimulation of the LC produced a profound disruption of sleep and significant reductions in the total amounts of NREM sleep, REM sleep, REM sleep as a percent of total sleep (NREM + REM sleep), and total sleep. Results suggest that the LC has a role in maintaining normal sleep patterns.
Adult↗
Adverse effect of splenectomy in experimental peritonitis.
Patients undergoing splenectomy have increased operative morbidity and mortality, especially when associated with gastrointestinal surgery or injury. This present study was designed to assess the effect of splenectomy on mortality in a polymicrobial fecal peritonitis model and evaluate therapy with antibiotic (cefoxitin) or immunomodulation (glucan). Human stool-barium (0.15 cc) was placed in the peritoneum of Sprague-Dawley rats at the time of splenectomy or sham surgery. Splenectomy animals were then treated with 5% dextrose, cefoxitin (60 mg im q 6 hr), glucan (7.5 mg ip prior to surgery), or cefoxitin plus glucan. Splenectomy resulted in decreased survival (5% vs 30%, P less than 0.05). Treatment with cefoxitin (90%) or glucan (47%) significantly improved survival. Combined glucan-cefoxitin therapy had no improvement over cefoxitin alone. Peritoneal and blood cultures were performed 12 hr postoperatively. There were no significant differences in growth of bacteria between sham and splenectomy animals. Cefoxitin treatment resulted in lower growth of bacteria from both blood and peritoneum (P less than 0.05). Glucan treatment caused a significant decrease in the number of bloodborne bacteria (P less than 0.05). Intravascular colloidal carbon clearance and leucocyte counts were performed at 12 hr postoperatively. Presence of peritonitis significantly enhanced intravascular clearance, while splenectomy had no effect. Addition of glucan or cefoxitin therapy to splenectomy animals did not enhance intravascular clearance. Leucocyte counts were significantly lower (P less than 0.05) when splenectomy was added to peritonitis animals. Glucan and cefoxitin therapy did not increase leucocyte counts. Based on these studies we conclude that (1) splenectomy increases mortality in fecal peritonitis, (2) antibiotic and immunomodulator afford some protection, and (3) exact mechanism of protection remains unclear.
Adjuvants, Immunologic↗
Etiology of acute conjunctivitis in children.
To determine the etiology of acute conjunctivitis in children seen in pediatric practice, 99 patients with conjunctivitis and 102 age-and season-matched controls were cultured for aerobic bacteria including Haemophilus influenzae, and for viruses, Chlamydia trachomatis, and mycoplasmas. Agents statistically associated with conjunctivitis included H. influenzae (42% vs 0%), Streptococcus pneumoniae (12% vs 3%), and adenoviruses (20% vs 0%). One of these three etiologic agents was isolated from 71 (72%) of the patients. Simultaneous infection with two pathogens was uncommon. Staphylococcus aureus was equally prevalent in diseased and control eyes; one strain of C. trachomatis was isolated from a control eye. Although there were variations in the clinical features of viral and bacterial conjunctivitis, differentiation in an individual patient was difficult. An adenovirus was isolated from 11 (65%) of 17 patients who had pharyngitis in addition to conjunctivitis. H. influenzae was isolated from 14 (74%) of 19 children who had both otitis and conjunctivitis. Adenovirus conjunctivitis was common in the fall and H. influenzae in winter.
Acute Disease↗
Fluidized bed adsorption for whole broth extraction.
Fluidized bed adsorption using a high-density synthetic resin has proven to be an invaluable technique for separating novel compounds from unfiltered fermentation broths during the very early stages of fermentation development, where product concentrations are typically in the parts per million range. Previous initial downstream processing strategies consisted of cell separation from whole broth or direct extraction with water-immiscible solvents, both of which resulted in lengthy time cycles, conflicts with existing operations requiring the use of high-cost centrifugal separators, and environmental/solvent recovery concerns. Laboratory and subsequent pilot plant process development work along with concomitant improvements in yield, quality, and time cycles are presented for one of several fluidized bed processes piloted in Merck's Natural Product Isolation facility.
Adsorption↗
A comparative study of bacampicillin hydrochloride, penicillin V, and amoxicillin in the treatment of acute tonsillitis and/or pharyngitis due to beta-hemolytic streptococci.
Fifty-five outpatients with acute tonsillitis and/or pharyngitis due to group A beta-hemolytic streptococci were treated during 1978 and 1979. Twenty-nine patients received 400 mg of bacampicillin twice a day, 21 patients received 250 mg of penicillin V four times a day, and five patients received 250 mg of amoxicillin every 8 hr. All except one patient, who was treated with bacampicillin, had a satisfactory clinical response to treatment. The bacteriologic response was satisfactory in all but one patient. None of the 55 patients developed adverse effects that necessitated the discontinuance of the antibiotic in use. No significant differences were found between the clinical or the bacteriologic responses to bacampicillin, penicillin V, or amoxicillin (Fisher's exact test).
Acute Disease↗