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At least 163 records · Page 9Linked to original sources
PubMedDate not supplied

Lower respiratory tract infection therapy--the role of ciprofloxacin.

Lower respiratory tract infections account for a large proportion of prescribed antibiotics and, with emerging resistance to standard agents, the introduction of the fluoroquinolones, in particular ciprofloxacin, has provided a further component in the armamentarium. This review encompasses 37 published clinical trials which featured ciprofloxacin; 3274 patients with lower respiratory tract infections were treated with this agent; in 94.1% of patients treatment was clinically successful and 90.9% of cases showed eradication of the causative pathogen. When these data were supplemented with previously unpublished information from the clinical trial database, specific organism eradication rates of 86.1%, 96.2% and 94.6% for Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, respectively, were observed. These findings suggest that the high respiratory tissue penetration of ciprofloxacin and the achievable minimum inhibitory concentrations lead to acceptable clinical outcomes in lower respiratory tract infections.

Adult↗
PubMed2000

A process for ensuring optimal cardiovascular intervention and identifying candidates for glycoprotein IIb/IIIa receptor inhibitor therapy.

Data from trials with glycoprotein (GP) IIb/IIIa receptor inhibitors have led to a new standard of care for patients with unstable angina or non-wave myocardial infarction (MI) who are undergoing percutaneous coronary intervention. Additional data are necessary to compare patient responses to various GP IIb/IIIa agents in a nontrial setting with results from clinical trials. Seton Medical Center has designed a database to accommodate this task. Data from >20,000 patients have been collected since 1979 and the interventional experience from the years 1997 through 1999 has been analyzed for patients who were candidates for receiving these agents. The data are being used to evaluate the outcomes of therapy and to devise models that can stratify patients according to risk, thereby ensuring optimal cardiovascular intervention and choice of the most cost-effective GP IIb/IIIa inhibitor agent.

Abciximab↗
PubMed1989

A microcomputer-based clinical trial database incorporated with an 'audit trail' for correction process.

Multicenter clinical trials usually involve several hundred research variables with tens of thousands of records and require mainframe computers for processing. Because of recent advances in hardware and software, it has become possible to support data management and statistical analysis for a complex research project totally on a microcomputer. The Veterans Administration Cooperative Studies Program Coordinating Center (CSPCC) in Hines, IL, U.S.A. has successfully implemented three studies employing the SIR/PC Database Management System (DBMS) on an IBM PC AT. The CSPCC DBMS was designed with a method of verifying data and of updating the database, that leaves a more detailed 'audit trial' of the original data and subsequent modifications than provided by the SIR audit trail facility. Data validation can be done at any time throughout the study to facilitate error identification as early as possible in the data handling process. DBMS operation and maintenance are automated by a system of menus. The utility programs are prestored in a procedure file to optimize performance. The simple design speeds implementation and also reduces the cost of development.

Clinical Trials as Topic↗
PubMed1991

ABLEDATA: a database of products for the disabled.

ABLEDATA (ABLE), a database funded by the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education and produced by the Adaptive Equipment Center of Newington Children's Hospital, Newington, Connecticut, provides information on more than 17,000 rehabilitation products from over 2,000 manufacturers in the U.S. and Canada. ABLE, which is available through BRS Search Service, BRS Colleague, and BRS After Dark, is a useful resource for rehabilitation professionals and others who wish to locate appropriate assistive devices for all categories of disabled persons.

Canada↗
PubMed1993

The safety of sumatriptan in asthmatic migraineurs.

A recent report has questioned the safety of sumatriptan in asthmatic migraineurs. To investigate this, we have reviewed the sumatriptan clinical trial safety database of over 75 completed trials. Within the clinical trial database, 375 asthmatic patients were identified who treated 1214 migraine attacks with sumatriptan. The incidence and nature of adverse events in the asthmatic patient subgroup who received sumatriptan was similar to that in the complete clinical trial population. Six reports of asthma were recorded as adverse events, but only one case was classified by the investigator as related to treatment. There is no clinical or pharmacological evidence to suggest that the safety profile of sumatriptan is altered in asthmatic patients compared to other migraine sufferers.

Asthma↗
PubMed1996

A model for storage and retrieval of theoretical medical knowledge.

A database model for structure and access of theoretical medical knowledge is presented. The basic principle is the organization of knowledge in three dimensions: Each topic--first dimension--is explained with media--second dimension--in different versions of varying details--third dimension--suitable for different users. Every topic is one database entry. Topics are interconnected with heading and sub-topics (tree structure) and to logically related topics (cross references). Access follows the 3D-concept with initial access by topic, by media, or user specific, and with intra-unit access to related topics, media, and user specific versions. The model is discussed and possible implementations are described.

Computer-Assisted Instruction↗
PubMed1998

Bridging studies.

The duplication of usually large-scale efficacy trials to generalise the clinical database of a new vaccine to other populations can be avoided by bridging studies. Immunogenicity data can easily be used to extrapolate efficacy results when the immune response correlates with vaccine induced immunity. In the absence of such a correlate of protection, the bridging process will be more controversial. Previous experiences should be valuable in identifying the factors, either ethnic or vaccine-related that may have an influence on vaccine efficacy. The probability that such a factor is associated with a clinically significant difference in efficacy is critical to the decision to conduct a bridging study. Bridging studies are designed to demonstrate equivalent immunogenicity i.e. exclude a clinically significant difference in the immune response between the population in whom efficacy was shown and the population to whom those efficacy results are extrapolated.

Clinical Trials as Topic↗
PubMed1997

Analyzing the research record of an institution's list of faculty publications.

Few health sciences libraries maintain databases and produce bibliographies of the publications of their institution's faculty. By offering such services, libraries can provide faculty members with a qualitative analysis of where and how their research is cited and its impact in the fields of biomedicine and related health sciences. Journal Citation Reports (JCR), produced by the Institute for Scientific Information, is a powerful tool that provides information on citations appearing in the largest, most frequently used, most cited, and highest-impact journals. This paper discusses the role libraries play in providing information about faculty publications, reviews how JCR is used by libraries, discusses how the Ehrman Medical Library of the New York University Medical Center uses JCR, and makes recommendations for the use of JCR to strengthen the librarian's role in providing information to faculty about the value of their research.

Bibliographies as Topic↗
PubMed1997

The safety of ranitidine in over a decade of use.

BACKGROUND: Ranitidine hydrochloride (Zantac) is one of the most extensively studied and widely used drugs of all time. This has provided an excellent opportunity to define its safety profile. METHODS: Data from 189 controlled clinical trials in which more than 26,000 patients received daily doses of ranitidine for 4 weeks or more were reviewed. More than 80% of patients were treated with up to 300 mg ranitidine daily; the remaining patients received doses of up to 1200 mg daily. Eighty-seven trials were placebo controlled. Analyses of post-marketing surveillance and a database of all spontaneously reported adverse events were also evaluated. RESULTS: Overall in the clinical trial programme adverse events were reported by 20% of those receiving ranitidine compared with 27% of those receiving placebo. The pattern of events was similar in all treatment groups with no evidence of dose-related toxicity in regimens encompassing an eightfold range of therapeutic doses. Similarly in a programme of studies designed to evaluate a dose of ranitidine of 75 mg for non-prescription (over-the-counter) use in the treatment of heartburn, ranitidine was not associated with an adverse event profile distinct from that of placebo. Analysis of spontaneously reported adverse event data allowed identification of rare idiosyncratic events. CONCLUSIONS: Review of data from a large population of controlled clinical trials with analyses of postmarketing surveillance studies and spontaneously reported adverse events confirmed the excellent safety profile of ranitidine.

Anti-Ulcer Agents↗
PubMed2000

Do mucosal defensive agents improve the cure rate when used with dual or triple therapy regimens for eradicating Helicobacter pylori infection?

BACKGROUND: Some of mucosal defensive agents have anti-Helicobacter pylori activities. However, their effectiveness in eradicating H. pylori infection has not been evaluated. AIM: To assess the additive effect of mucosal defensive agents in eradication regimens using statistical analysis. METHODS: Pertinent studies were retrieved using the Medline and the Igaku-chuo-zasshi databases in Japan, reference and congress abstract lists. Studies in which regimens consisted of dual or triple therapy with mucosal defensive agents and without them, were selected from the retrieved studies. Eradication rates were extracted from studies according to intention-to-treat analysis. We evaluated the efficacies of mucosal defensive agents by pooled relative risk of eradication rates and its 95% confidence intervals (95% CI), which were calculated by Mantel-Haenszel method. Heterogeneity among the studies in treatment effect was evaluated by a chi2-test. RESULTS: In dual therapy regimens, mucosal defensive agents demonstrated significant additive effects (pooled relative risk 1.41; 95% CI: 1.24-1.61). In triple therapy regimens, these agents did not provide significant additive effect. The clinical usefulness of specific agents could not be established, when each agent was analysed independently. CONCLUSIONS: Mucosal defensive agents improve the cure rate when used with existing dual therapy regimens for eradicating H. pylori infection.

Anti-Ulcer Agents↗
PubMed1999

The publication rates of presentations at major Spine Specialty Society meetings (NASS, SRS, ISSLS).

STUDY DESIGN: A review of all the presentations at three major spine specialty meetings held over a 3-year period. OBJECTIVES: To determine the rate of publication in peer-reviewed journals after presentations at major spine meetings conducted annually by the following three organizations: North American Spine Society (NASS), Scoliosis Research Society (SRS), and International Society for the Study of the Lumbar Spine (ISSLS). SUMMARY OF BACKGROUND DATA: The rate of publication for presentations at national and international meetings has been determined for medical and surgical subspecialties. This rate has been used to judge the quality of the content of the meetings and to determine the validity of the research presentations. METHODS: All presentations either in poster or oral presentation form were entered into a database covering a 3-year period for spine specialty meetings conducted annually by the following three organizations: NASS 1990 to 1992, SRS 1991 to 1993, and ISSLS 1991 to 1993. A computer search for each abstract was performed with the Melvyl Medline Plus database to determine if the abstract had been published in a peer-reviewed journal from 1990 to the end of 1997. Publication rates for presentations at these three meetings were determined over a 3-year period. RESULTS: A total of 1186 abstracts were listed over a 3-year period in the final programs of these three meetings for the years 1991 to 1993 (SRS, ISSLS) and 1990 to 1992 (NASS). Of these 1186 abstracts, 516 were published in peer-reviewed journals, giving an overall publication rate of 43.5%. The publication rates for the three different meetings (NASS, SRS, ISSLS) were similar, with values of 40%, 47%, and 45% respectively. More than 90% of the publications resulting from these meetings were published within a period of 4 years from the data of the meeting. CONCLUSIONS: The publication rates of presentations at three major spine specialty meetings are high and quite comparable with the publication rates of meetings in other medical subspecialties. This reflects the high quality of the meeting programs and validates their selection process.

Congresses as Topic↗
PubMed2001

Selection of clinical, patient-reported, and economic end points in acute exacerbation of chronic bronchitis.

BACKGROUND: Acute exacerbation of chronic bronchitis (AECB) places tremendous burden on patients, providers, employers, and health care systems. OBJECTIVE: The purpose of this paper is to (1) review the clinical, patient-reported, and economic measures used to evaluate disease burden and treatment effectiveness in AECB in clinical trials and (2) propose a guide for selecting study end points in AECB that will help capture all the relevant disease outcomes. METHODS: Two literature searches of the PubMed database were conducted to identify studies of clinical trials in bronchitis and evaluate the clinical, patient-reported, and economic end points used in these studies. RESULTS: Previous studies have focused primarily on clinician-assessed outcomes, which do not capture the full impact of AECB on patients' lives. Reporting mechanisms for most end points have been inconsistent, limiting the ability to compare information or interpret differences. Previous studies have given limited attention to patient-reported outcomes and the economic implications of AECB. Patient-reported outcomes such as speed of symptom relief and work productivity are important parameters for assessing treatment effectiveness and provide practical information for treatment evaluation. CONCLUSIONS: Additional research is needed to develop, examine, and validate patient-reported outcomes and the indirect costs of AECB. Measuring the relevant clinical, economic, and patient-reported outcomes in AECB patients using standardized methods may lead to a clearer understanding of the disease burden and the role, effectiveness, and cost-effectiveness of antibiotic treatment.

Acute Disease↗
PubMedDate not supplied

Managing attribute--value clinical trials data using the ACT/DB client-server database system.

ACT/DB is a client-server database application for storing clinical trials and outcomes data, which is currently undergoing initial pilot use. It stores most of its data in entity-attribute-value form. Such data are segregated according to data type to allow indexing by value when possible, and binary large object data are managed in the same way as other data. ACT/DB lets an investigator design a study rapidly by defining the parameters (or attributes) that are to be gathered, as well as their logical grouping for purposes of display and data entry. ACT/DB generates customizable data entry. The data can be viewed through several standard reports as well as exported as text to external analysis programs. ACT/DB is designed to encourage reuse of parameters across multiple studies and has facilities for dictionary search and maintenance. It uses a Microsoft Access client running on Windows 95 machines, which communicates with an Oracle server running on a UNIX platform. ACT/DB is being used to manage the data for seven studies in its initial deployment.

Clinical Trials as Topic↗
PubMed2001

Twenty-two years of phase III trials for patients with advanced non-small-cell lung cancer: sobering results.

PURPOSE: To determine the changes in clinical trials and outcomes of patients with advanced-stage non-small-cell lung cancer (NSCLC) treated on phase III randomized trials initiated in North America from 1973 to 1994. PATIENTS AND METHODS: Phase III trials for patients with advanced-stage NSCLC were identified through a search of the National Cancer Institute's Cancer Therapy Evaluation Program database from 1973 to 1994, contact with Cooperative Groups, and by literature search of MEDLINE. Patients with advanced NSCLC treated during a similar time interval were also examined in the SEER database. Trends were tested in the number of trials, in the number and sex of patients entered on the trials, and in survival over time. RESULTS: Thirty-three phase III trials were initiated between 1973 and 1994. Twenty-four trials (73%) were initiated within the first half of this period (1973 to 1983) and accounted for 5,359 (64%) of the 8,434 eligible patients. The median number of patients treated per arm of the trials rose from 77 (1973 to 1983) to 121 (1984 to 1994) (P <.001). Five trials (15%) showed a statistically significant difference in survival between treatment arms, with a median prolongation of the median survival of 2 months (range, 0.7 to 2.7 months). CONCLUSION: Analysis of past trials in North America shows that the prolongation in median survival between two arms of a randomized study was rarely in excess of 2 months. Techniques for improved use of patient resources and appropriate trial design for phase III randomized therapeutic trials with patients with advanced NSCLC need to be developed.

Adult↗
PubMed1992

Efficacy and safety of sotalol in patients with complex ventricular arrhythmias.

Sotalol is a unique beta-blocker that prolongs repolarization. Its use in 626 patients with complex ventricular ectopic activity, as reported in the literature, resulted in suppression of arrhythmia in 50 to 60% of treatment attempts. Detailed analysis of data on arrhythmias in 356 patients that were entered prospectively into a database revealed a median reduction in ventricular premature beats of 76%, compared to a median suppression of repetitive ventricular ectopic activity of 91% and of episodes of nonsustained ventricular tachycardia of 97% (p = 0.002 vs reduction of ventricular premature beats). This marked antiarrhythmic potency of sotalol in repetitive ventricular arrhythmias is thought to be due to its class III activity. Drug efficacy was independent of age, sex, the presence or absence of organic heart disease and the degree of sotalol-induced prolongation of corrected QT interval. Evaluation of left ventricular function in 215 patients treated with the drug demonstrated that depression of left ventricular ejection fraction occurred far less frequently than expected with conventional beta-blockers. Even patients with severely depressed pump function tolerated sotalol surprisingly well. There is a propensity of the drug to aggravate arrhythmia, which resulted in serious proarrhythmic events in 30 (3.5%) of 853 patients. These often consisted of torsades de pointes (9 of 30 patients). Proarrhythmia occurred primarily within the first 3 days of dosing, and exhibited a dose-dependence. In conclusion, sotalol is an effective and well-tolerated antiarrhythmic drug in patients with complex ventricular ectopic activity.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2000

Evaluation of an antihypertensive therapy utilising meta-analysis of a clinical trial database.

The emphasis on evidence-based medicine and the use of safe, cost-effective therapeutic strategies demands that management decisions be based upon evidence derived from clinical studies. Whilst prospective double blind clinical trials are regarded as the gold standard, there is no doubt that meta-analysis has proved valuable in defining the benefits of antihypertensive therapy. The antihypertensive efficacy of lacidipine has been assessed in a retrospective meta-analysis of a series of clinical studies in which the drug was compared with placebo and all the major classes of antihypertensive agent. All of the studies entered into the meta-analysis were parallel group double blind trials. Efficacy was based upon the reduction in both systolic and diastolic blood pressure and the effect on heart rate at trough immediately prior to dosing during maintenance therapy. In placebo controlled trials a clear dose response relationship was apparent with blood pressure reductions that were significantly greater than that observed with placebo at doses of 2 mg lacidipine and above. In active control trials, diastolic blood pressure reductions of 10-15 mmHg were observed at the end of the monotreatment phases (> 6-8 weeks) with a final reduction of 15-20 mmHg with the efficacy of lacidipine being equivalent to that of the comparator drug. Comparable results were also achieved for the response rates to therapy which varied between 70 and 85% at the end of the monotreatment phase and 82-98 when combination with other antihypertensive agents was permitted. There was no evidence of cardio-acceleration in any of the trials where significant blood pressure reduction was detected. This retrospective analysis in a large population base confirms the documented antihypertensive efficacy of lacidipine and demonstrates the suitability of the drug as a first line antihypertensive agent.

Adrenergic beta-Antagonists↗
PubMed1996

Cancer risk factors for selecting cohorts for large-scale chemoprevention trials.

Many anticipate that application of findings in molecular genetics will help to achieve greater precision in defining high-risk populations that may benefit from chemopreventive interventions. We must recognize, however, that genetic susceptibility, environmental factors, and complex gene-environment interactions are all likely to be risk determinants for most cancers. Cohort studies of twins and cancer indicate that having "identical" genes is generally not a very accurate predictor of cancer incidence. Data from twin studies support the suggestion that environmental factors such as tobacco use significantly influence cancer risk. The complexities of the genetic contribution to disease risk are exemplified by the development of Duchenne muscular dystrophy in only one of monozygotic twin girls, hypothesized to be the result of X chromosome inactivation, with the distribution patterns of the X chromosome being skewed to the female X in the manifesting twin and to the male X in the normal twin. Evidence from transgenic and genetic-environmental studies in animals support the possibility of genetic-environmental interactions. Calorie restriction modifies tumor expression in p53 knockout mice; a high-fat, low-calcium, low-vitamin D diet increases prepolyp hyperplasia formation in Apc-mutated mice; and calorie restriction early in life influences development of obesity in the genetically obese Zucker rat (fafa). Such environmental modulation of gene expression suggests that chemoprevention has the potential to reduce risk for both environmentally and genetically determined cancers. In view of the growing research efforts in chemoprevention, the NCI has developed a Prevention Trials Decision Network (PTDN) to formalize the evaluation and approval process for large-scale chemoprevention trials. The PTDN addresses large trial prioritization and the associated issues of minority recruitment and retention; identification and validation of biomarkers as intermediate endpoints for cancer; and chemopreventive agent selection and development. A comprehensive database is being established to support the PTDN's decision-making process and will help to determine which agents investigated in preclinical and early phase clinical trials should move to large-scale testing. Cohorts for large-scale chemoprevention trials include individuals who are determined to be at high risk as a result of genetic predisposition, carcinogenic exposure, or the presence of biomarkers indicative of increased risk. Current large-scale trials in well-defined, high-risk populations include the Breast Cancer Prevention Trial (tamoxifen), the Prostate Cancer Prevention Trial (finasteride), and the N-(4-hydroxyphenyl) retinamide (4-HPR) breast cancer prevention study being conducted in Milan. Biomarker studies will provide valuable information for refining the design and facilitating the implementation of future large-scale trials. For example, potential biomarkers are being assessed at biopsy in women with ductal carcinoma in situ (DCIS). The women are then randomized to either placebo, tamoxifen, 4-HPR, or tamoxifen plus 4-HPR for 2-4 weeks, at which time surgery is performed and the biomarkers reassessed to determine biomarker modulation by the interventions. For prostate cancer, modulation of prostatic intraepithelial neoplasia (PIN) by 4-HPR and difluoromethylornithine is being investigated; similar studies are being planned for oltipraz, dehydroepiandrosterone, and vitamin E plus selenomethionine. The validation of biomarkers as surrogate endpoints for cancer incidence in high-risk cohorts will allow more agents to be evaluated in shorter studies that use fewer subjects to achieve the desired statistical power.

Animals↗