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"Williams, L P"
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A Prospective, Randomized Trial Examining the Efficacy and Safety of Clarithromycin in Combination with Ethambutol, Rifabutin, or Both for the Treatment of Disseminated Mycobacterium avium Complex Disease in Persons with Acquired Immunodeficiency Syndrome
This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P = .454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P = .027) and marginally higher than that of patients receiving C+E (7%; P = .057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92).
Journal Article
Safety, Tolerance, and Efficacy of Posaconazole Therapy in Patients with Nonmeningeal Disseminated or Chronic Pulmonary Coccidioidomycosis
Background. Coccidioidomycosis can be difficult to treat with available therapies, particularly in patients with progressive or disseminated disease. Posaconazole is a new azole antifungal with potent activity against Coccidioides species, the causative agent of coccidioidomycosis. Methods. Twenty patients with chronic pulmonary or nonmeningeal disseminated coccidioidomycosis were enrolled in a multicenter trial to study the safety and tolerability of posaconazole therapy, with efficacy as a secondary end point. Patients received posaconazole (400 mg/day) in capsule formulation for up to 6 months. Safety was evaluated on the basis of the occurrence of adverse events. A satisfactory efficacy response was defined as a ⩾50% reduction in the Mycoses Study Group score from baseline. Results. Seventeen (85%) of 20 patients had a satisfactory response to treatment. The median duration of treatment was 173 days. Paired baseline and end-of-treatment culture results for Coccidioides species were available for 4 patients, all of whom converted from being positive to being negative for Coccidioides species. Relapse was experienced by 3 of 9 patients who did not receive antifungal therapy during the follow-up period. In general, posaconazole therapy was well tolerated, with 12 of 20 patients reporting adverse events that were possibly or probably related to treatment. The most common adverse events were dry mouth (in 5 patients [25%]) and headache (in 3 patients [15%]). Conclusions. Courses of posaconazole therapy that were up to 6 months in duration were well tolerated in patients with coccidioidomycosis. Although this study was limited by the number of patients enrolled, it clearly demonstrates that posaconazole shows promise in the treatment of patients with coccidioidomycosis and warrants additional investigation in a full-scale clinical trial.
Journal Article
Utility of Caenorhabditis elegans for Assessing Heavy Metal Contamination in Artificial Soil
There is an increasing need for the development of soil bioassay protocols. Currently the only internationally standardized soil test organism is the lumbricid earthworm Eisenia fetida. Many alternate soil test organisms have been proposed. This work compares Caenorhabditis elegans to several other test organisms, including E. fetida, for heavy metals in soil. In this evaluation, such factors as ease of testing and culturing, duration of testing, soil volume needed, and the sensitivity of the organism were considered. Results show that C. elegans is more sensitive than most other organisms evaluated and is similar in response to E. fetida. The second issue compares C. elegans LC(50) values to heavy metals criteria specified in the US EPA regulations for land application of sewage sludge. Currently, the regulations are set on total metals in the soil and do not consider bioavailability of the metals. Regulations do not consider soil physiochemical properties, such as organic matter content, clay content, and cation exchange capacity, which have been shown to affect the availability of metals to soil organisms. While the C. elegans LC(50) values are above standard values in artificial soil, work in our lab indicates that the LC(50)s are below regulation values for other soil types. Due to the ease of culturing and testing, good sensitivity, along with the wealth of biological information and ecological relevance, C. elegans is a good organism for use in soil bioassays.
Journal Article
Adverse Outcome Analyses of Observational Data: Assessing Cardiovascular Risk in HIV Disease
Clinical decisions are ideally based on randomized trials but must often rely on observational data analyses, which are less straightforward and more influenced by methodology. The authors, from a series of expert roundtables convened by the Forum for Collaborative HIV Research on the use of observational studies to assess cardiovascular disease risk in human immunodeficiency virus infection, recommend that clinicians who review or interpret epidemiological publications consider 7 key statistical issues: (1) clear explanation of confounding and adjustment; (2) handling and impact of missing data; (3) consistency and clinical relevance of outcome measurements and covariate risk factors; (4) multivariate modeling techniques including timedependent variables; (5) how multiple testing is addressed; (6) distinction between statistical and clinical significance; and (7) need for confirmation from independent databases. Recommendations to permit better understanding of potential methodological limitations include both responsible public access to de-identified source data, where permitted, and exploration of novel statistical methods.
Journal Article
A Swimming-Associated Outbreak of Hemorrhagic Colitis Caused by Escherichia coli O157:H7 and Shigella Sonnei
Escherichia coli O157:H7 is increasingly recognized as a common cause of both epidemic and sporadic disease, notably bloody diarrhea and hemolytic-uremic syndrome. Common-source outbreaks have been traced to the consumption of contaminated hamburger,
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other foods,
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and drinking water
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. Person-to-person transmission is also well documented
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In 1987, Washington became the first state to mandate public health reporting of E. coli O157:H7 infections by physicians and diagnostic laboratories. Oregon instituted a similar requirement in August 1990, and all case reports are now followed with in-depth standardized interviews of patients that include questions about possible sources . . .
Journal Article
Gender Differences in Health-Related Quality of Life in Patients with HIV/AIDS
Background: In studies evaluating the general US population, patients in primary care, and patients with chronic conditions, women consistently report poorer health-related quality of life (HRQoL) than men; however, studies evaluating HRQoL in patients with HIV/AIDS have not completely corroborated those findings. The objective of this study was to evaluate gender differences in HRQoL for participants in a large randomized trial comparing antiretroviral regiments. Methods: AIDS Clinical Trials Group (ACTG) 320 was a randomized, blinded, placebo-controlled trial comparing the 3-drug regimen of indinavir + zidovudine (or stavudine) + lamivudine with the 2-drug combination of zidovudine (or stavudine) + lamivudine in subjects with CD4 cell counts less than 200 cells/μl and no prior treatment with protease inhibitors. Nine quality of life domains scored on 0-100 scales were assessed using the ACTG QOL 601-602 Health Survey at 3 points in the trial: baseline, 24 weeks and 40 weeks. Differences between men and women in HRQoL scores were assessed using the Wilcoxon rank-sum test and generalized estimating equation (GEE) models. Results: Overall, 202 females and 976 males were randomized to one of two treatment arms. Female participants were more likely to be black or Hispanic and tended to be younger. At baseline, females reported lower HRQoL scores than males in all of the domains except social functioning, and at week 40, women scored lower in all of the domains except overall health. In repeated measures models, women were found to score lower in all HRQoL domains except overall health, with significant differences of 3.5-6.7 points in 3 of the 9 quality of life domains: physical functioning, pain, and energy/fatigue. HRQoL scores improved for participants in the study over time and in response to potent treatment, and the improvements were similar for men and women. Conclusions: Women with HIV/AIDS report substantially poorer HRQoL than men with HIV/AIDS in several HRQoL domains. However, changes in domain scores over time and in response to treatment do not differ significantly by gender, implying that changes in domain scores may be better HRQoL outcomes to compare between HIV-infected men and women in clinical trials than mean domain scores.
Journal Article
Long-Term Effectiveness of Highly Active Antiretroviral Therapy on the Survival of Children and Adolescents with HIV Infection: A 10-Year Follow-Up Study
Background. Previous observational studies found highly active antiretroviral therapy (HAART) to be associated with improved survival among human immunodeficiency virus (HIV)– infected children and adolescents. However, these studies had limited follow-up of HIV-infected children undergoing HAART. Given that HIV infection is chronic and that exposure to HAART is likely to be life-long, there is a need to evaluate the long-term effect of HAART on survival in this population. Methods. The study included 1236 children and adolescents who were perinatally infected with HIV, who were on study or enrolled after January 1996 in a United States-based multicenter prospective cohort study (Pediatric AIDS Clinical Trials Group 219/219C), and who were not receiving HAART at baseline; subjects were observed for a maximum of 10 years through June 2006. A weighted Cox regression model was used to estimate the effect of HAART on survival, appropriately adjusted for time-varying confounding by severity. Results. At the end of the 10-year follow-up period (median duration of follow-up, 6.3 years; interquartile range, 4.3– 9.8 years), 70% of participants had initiated HAART. Lower CD4 cell percentages, total lymphocyte counts, and albumin levels were associated with an increased probability of initiating HAART. Eighty-five deaths were observed, and the mortality hazard ratio associated with HAART, compared with non-HAART regimens, was 0.24 after adjusting for measured confounding by severity (95% confidence interval, 0.11– 0.51). Conclusions. The use of HAART was highly effective in reducing mortality during the period 1996– 2006 among children and adolescents infected with HIV. With improved long-term survival, continued follow-up is necessary to evaluate the effects of prolonged use of HAART on potential adverse events, immune function, growth, sexual maturation, and quality of life in this population.
Journal Article
Pain Management for Unilateral Orchidopexy in Children: An Effective Regimen
Background
The reported high incidence of 30–60% postoperative pain after an elective day surgical orchidopexy is undesirable. We evaluated the efficacy of our analgesic regimen for unilateral orchidopexy in preschool children performed as a day surgical procedure.
Methods
Between January 2004 and December 2006, 247 children (mean age: 3.3 ± 1.6 years) underwent a unilateral orchidopexy as a day surgical procedure. They were prospectively analyzed for postoperative pain during a period of 48 h by using the Visual Analogue Scale (VAS). After standardized general anesthesia, all children had a 0.25% levo-bupivacaine hydrochloride ilio-inguinal block and a rectal diclofenac sodium suppository. Orchidopexy was performed through transverse inguinal and scrotal incisions. The wounds were infiltrated with 0.25% levo-bupivacaine hydrochloride at the end of the operation. Postoperatively acetaminophen and ibuprofen were given orally at regular intervals for 48 h.
Results
On first assessment in the recovery room, 148 out of 247 (60%) patients were pain-free, and 99 of 247 (40%) patients had pain: VAS score ranged from 3 to 10. By 3 h, 27 (11%) had mild-to-moderate pain, with VAS scores between 3 and 7. All children were discharged home at 4 h with no pain. At home, 95% were pain-free at 10 h and 97% by 24 h, with a declining pain score. All children were pain-free at 32, 40, and 48 h. Pain scores were unrelated to the duration of surgery (
r
s
= 0.54).
Conclusion
Clinical effectiveness of our institution analgesic regime justifies the performance of unilateral orchidopexy as a day-case procedure.
Journal Article