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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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PubMed1999

[Systematic reviews on infectious diseases. The Cochrane Collaboration].

BACKGROUND: Theoretically, doctors update their knowledge from the scientific literature, and bibliographic databases have made it possible to overcome many of the limitations with this information, but not all of them. When faced with a therapeutic issue, the practice of evidence based medicine requires the efficient access to information derived from controlled clinical trials (CCT). Reviews of the scientific literature are of increasing importance. The Cochrane Collaboration is dedicated to preparing, maintaining and disseminating updated, systematic reviews of CCTs of health care interventions, which are published in the Cochrane Library. OBJECTIVE: To describe the Cochrane Collaboration and to locate, with the greatest exhaustiveness possible, CCTs published in the journals "Enfermedades Infecciosas y Microbiología Clínica", describe their characteristics and include them in a global database of clinical trials maintained by the Cochrane Collaboration. METHODS: The CCTs were identified by systematic manual searches of all issues of the journal. A descriptive analysis of the CCTs located was made. RESULTS: A total of 24 CCTs were published in 15 years (1.6 per year), 10 were original articles and 14 were communications at congresses. All were done in Spain and the majority were done in hospitals. The most frequently researched question was antibiotic prophylaxis and all evaluated pharmaceutical interventions. The majority of the CCTs published had important information missing (phase of study, randomization, blinding, etc.). CONCLUSIONS: The identification of CCTs is a prerequisite for the development of systematic reviews. There were few clinical trials published in the 15 years of publication of this journal, and the most common characteristic is, clearly, the absence of basic data. The most common is a lack of on the phase of the clinical trial, the follow-up period, and funding sources. The idea of what experimental clinical investigation in infectious diseases is in our country needs to include the identification of CCTs published in other Spanish and international journals.

Bibliometrics↗

PubMedDate not supplied

The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database.

The thrombolytic predictive instrument (TPI) was developed to identify those patients most likely to benefit from thrombolytic therapy for acute myocardial infarction as well as to facilitate the earliest possible administration of this treatment. The TPI consists of predictive models derived from clinical data obtained from both clinical trials and data registries. These models are subject to potential bias due to combinations of primary data from different sources. The purpose of this investigation was to assess the influence of gender in developing the TPI database. In this database, there were 1,096 (22%) women and 3,826 (78%) men; only 38% of the women were enrolled in clinical trials, whereas 46% of the men were (p < 0.0001). Within clinical trials, there were few significant eligibility differences between women and men, as the vast majority of patients met eligibility standards for entry in these trials. However, within clinical registries, the women were older (p < 0.0001) and more often had elevated blood pressure on admission (p = 0.002). Multivariate logistic regression indicated that after adjustment for significant predictors of trial inclusion, women were 25% less likely to be included in clinical trials (odds ratio = 0.76, 95% confidence interval = 0.60, 0.96). In order to counter bias introduced by the exclusion of women from clinical trials, the TPI database included patients from non-trial settings. Carefully including patients from clinical registries or non-trial settings may be an important strategy in constructing generally applicable predictive instruments.

Aged↗

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↗

PubMed2002

Suicide risk in patients with anxiety disorders: a meta-analysis of the FDA database.

BACKGROUND: Previous reports of suicide risk in patients with anxiety disorders have been inconsistent. METHODS: Using the FDA database, we assessed suicide and suicide attempt risk among patients, participating in recent clinical trials evaluating new anti-anxiety medications, with diagnosis of panic disorder (PD), social anxiety disorder or social phobia (SP), generalized anxiety disorder (GAD), post traumatic stress disorder (PTSD), and obsessive compulsive disorder (OCD). RESULTS: Overall, among 20076 participating anxious patients, 12 committed suicide and 28 attempted suicide. The annual suicide risk rate was 193/100000 patients and annual suicide attempt risk was 1350/100000 patients. LIMITATIONS: Clinical trial data have limited applicability to clinical practice. Participants in clinical trials are a highly selected, nonrepresentative sample of the clinical population. A number of patients never complete clinical trials and thus data are based on a limited sub-sample. These trials were not primarily designed to assess suicide risk. CONCLUSIONS: Suicide risk in patients with anxiety disorders is higher than previously thought. Patients with anxiety disorders warrant explicit evaluation for suicide risk.

Adolescent↗

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↗

PubMed2002

High-dose versus conventional-dose chemotherapy as first-salvage treatment in patients with non-seminomatous germ-cell tumors: a matched-pair analysis.

BACKGROUND: The purpose of this study was to compare high-dose chemotherapy (HDCT) with conventional-dose chemotherapy (CDCT) as first-salvage treatment in patients with relapsed or refractory non-seminomatous germ-cell tumors (NSGCT). PATIENTS AND METHODS: One hundred and ninety-three patients with relapsed or refractory NSGCT, between 1981 and 1995, were identified from two large databases. In 74 of these, intensification of first-salvage treatment by HDCT was planned. Patients were matched based on primary tumor location, response to first-line treatment, duration of this response and serum levels of the tumor markers, human chorionic gonadotrophin (HCG) and alpha-fetoprotein (AFP). Multivariate analyses were performed using event-free survival and overall survival as primary endpoints. RESULTS: Full matches on all five factors were found for 38 pairs of patients; for a further 17 pairs, matches on at least four factors could be identified. Hazard ratios in favor of HDCT were obtained between 0.72 and 0.84 [confidence interval (CI) 0.59-1.01] for event-free survival and between 0.77 and 0.83 (CI 0.60-0.99) for overall survival, depending on the type of analysis. CONCLUSIONS: The current analysis suggests a benefit from HDCT, with an estimated absolute improvement in event-free survival of between 6 and 12% and in overall survival of between 9 and 11% at 2 years. This benefit is lower than expected from previous phase I/II studies.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

Must patients with advanced cancer choose between a Phase I trial and hospice?

BACKGROUND: Phase I oncology trials offer no meaningful chance for direct medical benefit and they may prevent patients with advanced cancer from receiving palliative care in a hospice program. However, it is not known whether dual enrollment in a Phase I trial and hospice is feasible. METHODS: Five hundred thirty-four Phase I trials were identified in a national online database, of which 179 (34%) accepted patients with a life expectancy of less than 6 months. Of these, 50 were selected randomly. Their principal investigators were surveyed by fax, with follow-up telephone calls and e-mails. Ninety-two hospices were selected randomly from a national database. Surveys were conducted by telephone with intake coordinators. Principal investigators were asked whether patients enrolled in hospice could also enroll in their trials if they were eligible in all other respects. Hospice intake coordinators were asked whether a patient with advanced cancer who met hospice eligibility criteria could also enroll in a Phase I trial. RESULTS: Surveys were completed by 45 of 50 principal investigators (90%) and by 89 of 92 hospices (97%). Although both groups were in favor of dual enrollment, principal investigators (41 of 45; 91%) were more likely to support dual enrollment than hospices (60 of 89; 67%; chi-square test, P = 0.004). Most hospices that did not support dual enrollment cited reasons that were based on concerns about payment or misunderstandings about the nature of Phase I trials. CONCLUSIONS: Most hospices and Phase I principal investigators believe that eligible patients should be allowed to enroll simultaneously in hospice and Phase I trials. These results suggest that the choice between hospice and a Phase I trial is a false dilemma and that greater collaboration in this area is needed.

Attitude of Health Personnel↗