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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 541 records · Page 30Linked to original sources
PubMed2000

Cefdinir: an expanded-spectrum oral cephalosporin.

OBJECTIVE: To review the antimicrobial activity, pharmacokinetics, clinical efficacy, and tolerability of cefdinir, an expanded-spectrum oral cephalosporin. DATA SOURCES: Literature was identified by a MEDLINE search (January 1983-November 1999) of the medical literature, review of English-language literature and bibliographies of these articles, and product information. STUDY SELECTION: Clinical efficacy data were selected from all published trials mentioning cefdinir. Additional information concerning in vitro susceptibility, safety, chemistry, and pharmacokinetic profile of cefdinir was also reviewed. DATA SYNTHESIS: Cefdinir, an oral expanded-spectrum cephalosporin, has a broad spectrum of activity against many gram-negative and -positive aerobic organisms, including Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis. Cefdinir is stable to hydrolysis by many common beta-lactamases. Cefdinir is rapidly absorbed from the gastrointestinal tract and is primarily eliminated via renal clearance of unchanged drug. The terminal disposition half-life of cefdinir is approximately 1.5 hours. Efficacy has been demonstrated in a number of clinical trials in adults and children with upper and lower respiratory tract infections (e.g., pharyngitis, sinusitis, acute otitis media, acute bronchitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia) and skin and skin-structure infections. The adverse event profile is similar to that of comparator agents. CONCLUSIONS: Cefdinir is a second-line alternative to first-line antimicrobial agents, with convenient once- or twice-daily dosing in the treatment of upper and lower respiratory tract infections and skin and skin-structure infections. Similar to other oral expanded-spectrum cephalosporins, cefdinir has activity against common pathogens of the respiratory tract and skin and is stable in the presence of many beta-lactamases. The clinical choice of an oral expanded-spectrum cephalosporin will be based on patient acceptance, frequency of administration, and cost.

Administration, Oral↗
PubMed2005

Treating pregnancy-related nausea and vomiting with ginger.

OBJECTIVE: To review literature assessing the safety and efficacy of the use of ginger to treat nausea and vomiting in pregnancy. DATA SOURCES: Iowa Drug Information Service (1966-September 2004), International Pharmaceutical Abstracts (1971-September 2004), MEDLINE (1966-September 2004), and EMBASE (1966-September 2004) were searched. Key terms included ginger, nausea, vomiting, emesis, and pregnancy. DATA SYNTHESIS: Studies evaluating the safety and efficacy of ginger in the management of nausea and vomiting in pregnancy were reviewed. Various doses and forms of ginger were used to treat women during their first and second trimesters of pregnancy. Ginger has been shown to improve the symptoms of nausea and vomiting compared with placebo in pregnant women. CONCLUSIONS: While data are insufficient to recommend ginger universally and there are concerns with product quality due to limited regulation of dietary supplements, ginger appears to be a fairly low-risk and effective treatment for nausea and vomiting associated with pregnancy. In low doses, this may be appropriate for patients not responding to traditional first-line therapies.

Clinical Trials as Topic↗
PubMed2002

System approach to modeling metabolite formation from parent drug: a working example with methotrexate.

The aim of this methodological study was to present and exemplify a system-approach-based technology in modeling the formation of the metabolite from the parent drug. To represent this process, the parent-metabolite dynamic system was defined in such a way that the concentration-time profile of the parent drug was considered the input, while the concentration-time profile of the metabolite the output, of this system. The system-approach-based modeling technology was used to determine the model of the parent-metabolite dynamic system and to obtain the model-based estimates of the rate of metabolite formation, the rate of metabolic ratio and the mean time of metabolite formation. The technology was applied to concentration data for methotrexate and 7-hydroxymethotrexate in patients with psoriasis after a single oral methotrexate dose. Third-order linear models were selected as optimal to approximate the parent-metabolite dynamic systems representing the formation of 7-hydroxymethotrexate from methotrexate of these patients. The model-based estimates of the metabolic ratios ranged from 0.53 to 0.95. The model-based estimates of the mean times of formation of 7-hydroxymethotrexate from methotrexate ranged from 9.13 to 25.13 h. The model-based estimates of the rates of formation of 7-hydroxymethotrexate from methotrexate reached peak values (ranging from 0.03 to 0.11 h-1) in the time interval 1.5-4.5 h after administration of methotraxate. This study does not only introduce the method that may be useful in gaining insight into metabolite formation, but also presents a new example of the methodological, conceptual and computational uniformity of the system-approach-based technology in modeling various biomedical systems.

Administration, Oral↗
PubMed2006

ISMB 2006.

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Animals↗
PubMed2003

Hepatic reactions during treatment of multiple sclerosis with interferon-beta-1a: incidence and clinical significance.

BACKGROUND: Hepatic dysfunction, manifested as liver enzyme elevations, occurs frequently in patients who are treated with interferon, however, data for patients with multiple sclerosis are limited. OBJECTIVE: To retrospectively assess the safety profile of interferon-beta-1a therapy with respect to liver function during clinical trials and postmarketing surveillance in the treatment of multiple sclerosis. PATIENTS AND METHODS: Adverse effects and laboratory abnormalities were analysed from six randomised, controlled clinical trials (five of which were placebo-controlled) that assessed the use of interferon-beta-1a in patients with multiple sclerosis. Treatment data were collected for 2819 patients for up to 12 months, of whom 1995 received interferon-beta-1a (337 [12%] received Avonex intramuscular therapy, and 1658 [59%] received Rebif subcutaneous therapy), and 824 (29%) received placebo. Data for 2 years were collated for 1178 patients (from two studies). Total weekly interferon doses were 22-132 microg. Postmarketing surveillance data were also analysed. RESULTS: In patients receiving interferon-beta-1a, there were significant elevations of alanine aminotransferase (ALT) levels, of all grades of severity, in up to 59% of patients at 6 months, up to 64% of patients at 12 months and up to 67% of patients at 24 months; ALT elevations were asymptomatic and dose related. More than 50% of elevations in liver enzymes occurred during the first 3 months of treatment, and more than 75% occurred during the first 6 months. Elevated enzyme levels resolved spontaneously or with dosage adjustment. Although the overall incidence of liver enzyme elevation was high during the early months of therapy, after 2 years, the proportion of patients with abnormal liver enzyme levels was 11% of those receiving Rebif 44 microg three times weekly compared with 6% of placebo-treated patients. Only 0.4% of patients discontinued interferon-beta-1a treatment because of hepatic adverse effects. Serious symptomatic interferon-related hepatic toxicity occurs, but is uncommon. Concomitant medication use was not associated with increased risk. CONCLUSION: Asymptomatic hepatic dysfunction is common in patients with multiple sclerosis who are treated with interferon-beta-1a, and is dose related. Adverse effects are mainly mild and transient, with little impact on adherence to therapy, although rare serious events can occur. Regular liver function monitoring during the first 6 months is recommended.

Adjuvants, Immunologic↗
PubMed2006

Verteporfin: a review of its use in the management of subfoveal choroidal neovascularisation.

Photodynamic therapy (PDT) with verteporfin (Visudyne), a photosensitising protoporphyrin derivative, is used in the management of subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) or pathological myopia (PM). PDT with verteporfin over 1 and 2 years reduces the decline in visual acuity in patients with classic-containing subfoveal CNV secondary to AMD. Verteporfin is generally well tolerated by most patients. Verteporfin is also effective in patients with CNV secondary to PM, although data in this indication are limited and further controlled studies are required. Although verteporfin has shown efficacy in patients with occult AMD-related subfoveal CNV lesions in early trials, data are currently limited on its first-line use in this indication; fully published data from the Verteporfin In Occult (VIO) trial are therefore awaited with interest. Verteporfin should be considered as a first-line treatment in patients with predominantly classic subfoveal CNV secondary to AMD, and in patients with smaller minimally classic subfoveal CNV lesions. It may also be considered an option for the treatment of patients with occult AMD-related subfoveal CNV in whom visual acuity decreases or predominantly classic features develop over time.

Aging↗
PubMed2005

Clinical pharmacogenomics and transcriptional profiling in early phase oncology clinical trials.

Microarray-based expression profiling studies in the field of oncology have demonstrated encouraging correlations between tumor transcriptional profiles and eventual patient outcomes. These findings have fueled great interest in the application of transcriptional profiling to samples available from real-time clinical trials, and clinical pharmacogenomic objectives utilizing transcriptional profiling strategies are becoming increasingly incorporated into clinical trial study designs. Over the last few years several retrospective studies based on the profiling of archival tumor tissues suggest that transcriptional analysis of oncology samples may provide general prognosis measures, and in some cases may even predict response to specific therapies. Recently the FDA released a voluntary genomic data guidance meant to assist both regulatory agencies and pharmaceutical companies alike in evaluating the potential benefit of implementing expression profiling studies during the preclinical and clinical phases of drug development. Despite the great promise afforded by this technology, the ultimate benefit of applying transcriptional profiling in prospective clinical trials has yet to be realized because a number of practical impediments to this process exist. The multi-fold purpose of the current review is to highlight the increasing evidence from studies that have identified transcriptional signatures in archived tumors prognostic of patient outcome, to describe some of the drivers for the implementation of transcriptional profiling strategies in real-time drug development, to discuss the use of transcriptional profiling in the context of increasingly complex translational medicine strategies, and to highlight the practical issues and potential approaches involved in the successful application of clinical pharmacogenomic objectives during real-time clinical trials. Strategic implementation of transcriptional profiling in early oncology clinical trials can provide an opportunity to identify predictive markers of clinical response and eventually provide a substantial step forward towards the era of personalized medicine.

Antineoplastic Agents↗
PubMedDate not supplied

Dimensions of evidence.

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Clinical Trials as Topic↗
PubMedDate not supplied

The National Cancer Data Base: ten years of growth and commitment.

The National Cancer Data Base (NCDB), now 10 years old, was created to provide a resource for assessing patient care and outcomes nationally and to circulate this information to the medical community. Dr. Partridge says the NCDB clearly has succeeded in fulfilling this and other goals and can be expected to continue to be an important source for evaluating patterns of cancer care in the United States.

American Cancer Society↗
PubMed2004

Are herbal medicines effective?

Herbal medicine is again popular and its widespread use demands that we assess its effectiveness objectively. The evidence in this area has grown considerably in recent years, not least due to the endeavors of the Cochrane Collaboration. They show amongst other things that it is possible to evaluate herbal medicines in much the same way as conventional drugs. By far the biggest hindrance to research into herbal medicine is the lack of funds available for this line of scientific investigation. In view of the present popularity of herbal medicine it seems necessary to overcome obstacles to rigorous research and establish which herbal medicines do more good than harm for which conditions.

Adult↗
PubMed2006

Evaluation of evidence for interprofessional education.

Based on recommendations from numerous organizations, educators in healthcare disciplines are implementing interprofessional training programs. Our objective was to summarize relevant literature in a way that would be most useful to clinician educators. Studies involving educational interventions in health professions to enhance learner-based outcomes relevant to the provision of interprofessional care were identified. We sought prospective, controlled trials in which at least 2 health care disciplines were represented, and 1 of which was medicine. Thirteen reports met the criteria for inclusion. Interventions varied widely in design and intensity, but generally included both didactic and clinical components and lasted several weeks or longer. Most studies used pretest/posttest controls and observed positive effects on learners' attitudes and knowledge. Combined clinical and didactic experiences may produce short-term improvements in learners' knowledge and attitudes about interprofessional care. Future research should employ control groups and validated, behaviorally oriented outcome measures whenever possible.

Controlled Clinical Trials as Topic↗
PubMed2006

Media reporting on research presented at scientific meetings: more caution needed.

OBJECTIVE: To examine media stories on research presented at scientific meetings to see if they reported basic study facts and cautions, and whether they were clear about the preliminary stage of the research. DESIGN AND SETTING: Three physicians with clinical epidemiology training analysed front-page newspaper stories (n = 32), other newspaper stories (n = 142), and television/radio stories (n = 13) identified in LexisNexis and ProQuest searches for research reports from five scientific meetings in 2002-2003 (American Heart Association, 14th Annual International AIDS Conference, American Society of Clinical Oncology, Society for Neuroscience, and the Radiological Society of North America). MAIN OUTCOME MEASURES: Media reporting of basic study facts (size, design, quantification of results); cautions about study designs with intrinsic limitations (animal/laboratory studies, studies with < 30 people, uncontrolled studies, controlled but not randomised studies) or downsides (adverse effects in intervention studies); warnings about the preliminary stage of the research presented at scientific meetings. RESULTS: 34% of the 187 stories did not mention study size, 18% did not mention study design (another 35% were so ambiguous that expert readers had to guess the design), and 40% did not quantify the main result. Only 6% of news stories about animal studies mentioned their limited relevance to human health; 21% of stories about small studies noted problems with the precision of the finding; 10% of stories about uncontrolled studies noted it was not possible to know if the outcome really related to the exposure; and 19% of stories about controlled but not randomised studies raised the possibility of confounding. Only 29% of the 142 news stories on intervention studies noted the possibility of any potential downside. Twelve stories mentioned a corresponding "in press" medical journal article; two of the remaining 175 noted that findings were unpublished, might not have undergone peer review, or might change. CONCLUSIONS: News stories about scientific meeting research presentations often omit basic study facts and cautions. Consequently, the public may be misled about the validity and relevance of the science presented.

Congresses as Topic↗
PubMed1994

Investigational drug tracking: Phases I-III and NDA submissions--Part I.

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I includes the trade name and synonym cross-indexes and the beginning of the main alphabetical listing by generic/chemical name or investigational drug number.

Catalogs, Drug as Topic↗