The effects of self-administering emergency contraception.
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Biomedical subjects
Publications and source records attributed to J S Gardner.
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BACKGROUND: The pre- and peri-natal drug exposures reported by women participating in a case-control study of children in Colorado were examined for association with infant craniosynostosis. METHODS: Mothers of case and control children underwent a standardized telephone interview and obstetric and newborn medical record review. The interview included questions on the use of prescription and non-prescription drugs, nutritional supplements, recreational and drugs of abuse. The mother's obstetric record was abstracted for information about pharmacologic agents taken before and during the antepartum period. RESULTS: There were no statistically significant risk ratios associating craniosynostosis with prenatal exposure to hydantoin, valproic acid, or cocaine. Mothers of four case children and one control child reported specific exposure to retinoic acid. There were no statistically significant increases in the odds ratio (OR) for any suture type among children exposed to hypoxigenic agents, sympathomimetic or parasympatholytic agents, or metal-containing agents. The OR was 1.87 (lower bound of the two-sided 95% test-based confidence interval (CI): 1.08) among children with sagittal/lambdoid suture synostosis who were exposed to nitrosatable drugs chlorpheniramine, chlordiazepoxide, and nitrofurantoin compared to controls. CONCLUSIONS: Certain nitrosatable drugs may be associated with increased risk of infant sagittal/lambdoid craniosynostosis. A possible mechanism related to ischaemia/reperfusion injury is suggested.
This study evaluates surface alterations produced on various implant surfaces by an ultrasonic scaler fitted with a nonmetallic tip. Commercially pure titanium and titanium alloy abutments, plasma-coated implants, and hydroxyapatite-coated implants were contacted with the nonmetallic tip for 10 seconds and then evaluated for surface changes by SEM examination. The commercially pure titanium and titanium alloy surfaces showed negligible alterations from the control, thus indicating possible clinical use as a maintenance device. More severe changes were evidenced with the plasma- and hydroxyapatite-coated surfaces.
Pharmacists are well positioned to play a major role in increasing access to emergency contraceptive pills (ECPs). A pilot project in Washington State is testing direct pharmacist prescribing. Through a collaborative drug therapy agreement, a licensed prescriber, such as a physician, delegates to a pharmacist the authority to prescribe ECPs directly to women who meet the assessment criteria. Currently pharmacists at 111 Washington State pharmacies have collaborative agreements in place, and the number of participating pharmacies continues to increase. The response to this initiative has been extremely positive. Women who have received ECPs directly from pharmacists rate their interactions with the pharmacists positively and overwhelmingly cite convenience as the primary reason for going directly to the pharmacy. Physicians and other providers with independent prescribing authority can play a pivotal role by working with pharmacists to replicate the Washington State initiative in the states that allow it.
The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study designed to comply with the US FDA's request that 10,000 users of ROGAINE (REGAINE in international markets) Topical Solution 2% (2% minoxidil solution) be systematically studied in the first year following the product's approval. Members of the Drug cohort were recruited at the time they filled prescriptions for 2% minoxidil solution at cooperating retail pharmacies in the United States. To meet the need for rapid identification of a cooperative comparison group, the Comparator cohort was selected by stratified random sampling from members of a commercial consumer panel. Group matching of Comparators to the Drug cohort on four variables--age, sex, race, and geography of residence--was accomplished prior to recruitment on the basis of information available from the consumer panel records; education was obtained via consent procedures and was also used as a group matching variable. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. Interviewing costs averaged 18.88 US dollars/completed interview. A commercial consumer panel offers a pool of rapidly identifiable subjects with known demographic characteristics and established willingness to participate in research for efficient cohort recruitment.
The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study of users of ROGAINE (REGAINE in international markets) Topical Solution 2% (N=11,122) and a Comparator cohort (N=11,173) which was selected and group matched by stratified random sampling from among members of a commercial consumer panel. Study endpoints were confirmed cause-specific deaths and hospitalizations within 12 months of study entry. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. At least 94% of both cohorts completed 12 months of follow-up, with the completion rate highest in the Comparator cohort (96.8%). Although successful matching was achieved on the demographic variables used to select the Comparators, members of the two cohorts differed significantly in the presence of baseline chronic medical conditions and other risk factors for study endpoints. A commercial consumer panel is valuable for rapid selection of demographically-matched comparators for targeted cohorts which continue in the study through long-term follow-up. Multi-stage sampling may need to be employed when more specific characteristics must be identified.
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BACKGROUND: Fetal mice homozygous for the Disproportionate micromelia (Dmm) gene were studied as a model for pulmonary hypoplasia in chondrodystrophy. METHODS: Wet weight, dry weight, and biochemical content were determined in excised whole lungs, terminal sac morphology and presence of multilamellar bodies were determined by electron microscopy, and volume of the thoracic space was estimated from paraffin casts. Lung development of the mutant was further assessed in whole organ culture. RESULTS. Compared with normal littermates, the mutant showed a significant decrease (28%) in lung wet weight without showing altered lung dry weight or tissue content of DNA and protein. The terminal sacs of lungs fixed by intratracheal instillation were significantly smaller than normal. However, the lungs appeared to have undergone maturation on schedule since the surfactant precursors, multilamellar bodies, were observed and normal tissue-levels of phospholipid were detected. The volume of the mutant's thorax was markedly reduced. Finally, the mutant's lungs when removed from the fetus prior to the onset of thoracic dystrophy (day 15) and cultured for three days demonstrated that, without the confining influence of a reduced thoracic space, they are capable of development comparable to normal. CONCLUSIONS: These findings support the hypothesis that the Dmm mutant can be further studied as a model for human pulmonary hypoplasia associated with chondrodystrophy, and that the relationship between the reduced thorax and the lung disorder is cause-and-effect.
After the Food and Drug Administration approved a topical antibiotic for the treatment of acne, we began a postmarketing surveillance study to measure the frequency of antibiotic-associated colitis and diarrhea in acne patients treated with topical antibiotics and low doses of oral antibiotics. Pharmacists recruited 13,465 patients who presented a prescription for an acne medication, and we obtained detailed information on the use of the medications, perceived acceptability, and the occurrence of new health events from 6,453 with computer-assisted telephone interviews. Three cases (less than 0.1%) of antibiotic-associated diarrhea and one case (less than 0.1%) of antibiotic-associated colitis were confirmed. We conclude that this methodology can provide further information about the safety of a drug once it is in customary use, at a fraction of the cost of Phase III clinical trials.
The present study was performed to provide a better understanding of the morphological variations of mammalian hair. Terminal hair samples were obtained from different regions of the body of the same Caucasian male. All hair samples were either cleaned or treated before being examined with scanning electron microscopy. As human scalp hair grew it appeared small like lanugo hair, but the increase in diameter appeared to have been relatively rapid. As hair increased in diameter the appearance of the scales changed. Neck hair was slightly smaller in diameter than scalp hair, and axillary hair was slightly smaller in diameter than neck hair. Nostril hair was larger than scalp or axillary hair. Eyelash hair was much smaller and much shorter than eyebrow hair. Neck hair, forearm hair, and shin hair were smaller than hair from most other regions of the body. Chest hair was similar in size to scalp hair, and pubic and sideburn hair were larger than scalp hair. A morphological feature called "steak-boning" was more characteristically present in whiskers of Caucasoids than Orientals or Blacks. "Steak-boning" occurred most frequently in hair of the mustache, followed by that of the chin, sideburn, cheek and under the chin. Cut surfaces of whiskers were different for electric as compared with straightedge razors. Hair morphology varied relative to the body region. Computer analysis of resin-embedded hair made it possible to classify arm, mustache, cheek, chin, head, shin, and pubic hair, and to quantify cross-sectioned differences.
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We describe a quantitative method of analysis for assessing stability of human monoclonal antibody production by hybridomas. Clones derived from fusion between the SHM-D33 heteromyeloma line and EBV-stimulated human lymphocytes were studied for antibody presence using a fluorescent labelling technique. Frequencies of antibody-negative variants in clonal populations were measured, and measurements on parallel clonal populations were subjected to Luria-Delbrück fluctuation analysis to compute rates of generations of antibody-negative cells. Independent hybridoma clones exhibited a range of stabilities and the corresponding rates varied between 5 X 10(-4) and 6 X 10(-2) cell-1 generation-1. Rates of generation of antibody-negative variants for the more stable heteromyeloma hybridomas compared well with those of 2 established mouse hybridoma lines tested (less than 10(-3) cell-1 generation-1). There was a positive correlation between frequency of antibody-negative variants measured in clonal populations grown to large numbers of cells (greater than 10(7) per culture) and their rate of loss of antibody production. Large variations in frequency of antibody-negative variants were observed in parallel clonal populations, suggesting that loss of ability to produce antibody is due to random, mutation-like events including chromosome loss (Luria and Delbrück, 1943). High frequencies of antibody-negative variants may indicate imminent loss of antibody-producing capacity by a clone growing in suspension culture.
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Developing Tilletia caries teliospores were studied with thin sectioning procedures. After the W1 and W2 spore walls are formed, lamellar material begins to form adjacent to the W2 wall layer. The patches of lamellar material become continuous, and additional layers are added. After the W3 wall starts to form, the lamellar material is difficult to see without special staining. The lamellar material makes it difficult to get resins to penetrate the partition layer of teliospore walls.
Tilletia indica teliospores were studied by use of thin sections and freeze-etch replicas. Surfaces of these spores have rodlet patterns which differ from those previously reported for spores of other fungi. The rodlets on T. indica teliospores average 240 nm in length and are not grouped into fascicles.
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