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At least 343 records · Page 19Linked to original sources

PubMed1999

Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress.

PURPOSE: All cooperative group studies performed in North America for patients with extensive-stage small-cell lung cancer (SCLC) were evaluated to determine the pattern of the clinical trials and the outcome of patients over the past 20 years. PATIENTS AND METHODS: Phase III trials for patients with extensive-stage SCLC were identified through a search of the National Cancer Institute Cancer Therapy Evaluation Program database from 1972 to 1993. Patients with extensive-stage SCLC treated during a similar time interval listed in the Surveillance, Epidemiology, and End Results (SEER) database were also examined. Trends were tested in the number of trials over time, the number and sex of patients entered onto the trials, and the survival time of patients treated over time. RESULTS: Twenty-one phase III trials for patients with extensive-stage SCLC were initiated between 1972 and 1990. The median of the median survival times of patients treated on the control arms of the phase III trials initiated between 1972 and 1981 was 7.0 months; for those patients enrolled onto control arms between 1982 and 1990, the median survival time was 8.9 months (P =.001). Analysis of the SEER database of patients with extensive-stage SCLC over the same time period shows a similar 2-month prolongation in median survival time. CONCLUSION: Analysis of 21 phase III trials initiated in North America and the SEER database from 1972 to 1994 demonstrates that there has been a modest improvement in the survival time of patients with extensive-stage SCLC.

Carcinoma, Small Cell↗

PubMed1994

Breast cancer outcome and predictors of outcome: are there age differentials?

Several questions were addressed regarding breast cancer outcome, predictors of outcome, and young age at diagnosis. Is there evidence that outcome is worse in younger women compared with other age groups? Do younger patients have a greater frequency of adverse prognostic factors? If younger age is associated with a poor outcome, is it an intrinsic independent adverse predictor, or is the outcome worse due to poor prognostic factor profiles? Several methods were used to answer these questions and applied to those reports in which age categories were carefully defined: 1) detailed review of population-based breast cancer outcome literature, 2) synthesis of published cooperative group and single institution univariate and multivariate analyses, and 3) a new analysis of the 8738-patient San Antonio database. Overall, epidemiologic studies suggested that younger women have the worst survival outcome, when matched with similarly staged older cohorts. Univariate trends analyses confirmed that younger women more often had more positive lymph nodes, larger tumors, and negative steroid hormone receptors. Significantly more cancers in women less than 35 years of age had high S-phase fractions and abnormal expression of p53. Multivariate modeling confirmed that young age was an independent adverse predictor when a few standard factors were considered in the model, but other descriptors such as tumor grade or high S-phase fraction were more important when available. These data support the conclusion that "young age" serves as a surrogate for a greater frequency of adverse prognostic factor profiles and suggest important questions for future study.

Adult↗

PubMed2005

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.

Adverse Drug Reaction Reporting Systems↗

PubMed2001

Use of internet technologies for data acquisition in large clinical trials.

Data acquisition for automated processing is a central aspect of clinical trials with large numbers of cases because of their extensive demand for manpower. Scientific data can be collected using data forms, which are created in Hypertext Markup Language and published on the Internet. The completed data form can be returned via E-mail or Common Gateway Interface-Script and forwarded into a study database. For the Internet-based data acquisition of a prospective multicenter trial (e.g., on endophthalmitis incidence after cataract extraction), we developed two special HTML forms that can be opened in the ophthalmology department's homepage. A large number of acquired anonymous data has been collected via Internet and automatically transferred into the trial database. The Internet provides a fast and easy avenue for the acquisition of scientific data. This method of data acquisition and data processing will become more common place in multicenter clinical trials.

Clinical Trials as Topic↗

PubMedDate not supplied

Clinical databases in nephrology: research and clinical practice goals and challenges.

In clinical practice we formulate direct questions related to patient management that should be answered on the basis of results of valid studies. Bias problems are dealt with using different approaches in observational studies and in clinical trials. The clinical trial is the standard for assessing the efficacy of treatments while the efficiency of treatments at community level is better captured by observational studies. Electronic medical records have now emerged as a precious, matchless data source for clinical audits. The value of an audit cannot be taken for granted and should be tested in the specific health care setting where it is applied. Electronic medical records and high quality clinical databases offer a great opportunity for performing observational studies and for reducing the cost of clinical trials. Research on audit and feedback functionality is a new, useful and stimulating research area which may be of great interest to nephrologists.

Clinical Audit↗

PubMed1988

Report from the panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials.

A plenary session at the Eighth Annual Meeting of the Society for Clinical Trials addressed "The Case for Registers of Clinical Trials." There are a number of reasons for having registers of clinical trials: to promote collaboration and communication among investigators regarding new and ongoing clinical trials, to provide a basis for methodologic research, and to facilitate meta-analysis by the availability of a system of trial identification that is independent of the published literature. The experience gleaned by those involved with two existing trial registers, the International Committee on Thrombosis and Haemostasis Registry and the Oxford Database of Perinatal Trials, can be used to provide insight into the issues generic to trial registration. The time perspective to be used, inclusion and exclusion criteria, the practicability of comprehensive prospective registration, and funding are central considerations for these and other registers.

Clinical Trials as Topic↗

PubMed2001

Fetal tissue transplantation for patients with Parkinson's disease: a database of published clinical results.

Over the past 13 years approximately 300 patients with Parkinson's disease have received transplants of human fetal dopamine cells in an attempt to reduce or control disease symptoms. Many of these patients have had improvements in their motor skills and a reduction in their daily levodopa administration. However, improvements are far from guaranteed and questions need to be answered before this technique can be widely applied. To help address some of these issues, a search of all the published results of patients with Parkinson's disease transplanted with human fetal tissue was conducted. This generated a database of 70 transplant recipients who had their levodopa administration and clinical benefit reported both prior to transplant and at least 6 months post-transplant. Furthermore, the number of years of disease onset prior to transplant was available for all recipients. This database was examined for motor improvement and reduction in levodopa dosage for up to 2 years post-transplant to determine the effects of time on transplant outcome. The database showed that most recipients had significant improvements in motor skills and levodopa administration, and that most benefits were observed in the first 6 months post-transplant. In addition, the database demonstrated that the number of years of disease onset prior to transplantation was not a predictor of patient outcome 1-year post-transplant. Current and future directions in fetal tissue transplantation research and replacements for fetal tissue are discussed.

Animals↗

PubMed2003

Haemophilia--paucity of evidence, ways forward?

Although the basic management of people with haemophilia is agreed, much of this is based on historical experience. By today's standards the precise details of how much treatment is enough are not based on a good evidence framework. Although regular treatment with prophylaxis is widely believed to be optimal, the evidence for this has not been considered strong enough by some authorities to justify the considerably increased expenditure. Reviews available on the Cochrane Database provide regularly updated evidence in a given field and, where there is inadequate evidence, a review may identify what kinds of trials are needed. The Cochrane Review Group have identified 152 references to 127 trials relating to haemophilia A and B, and von Willebrand disease. Most of the trials in haemophilia are short-term comparisons of treatments such as trials with coagulation factor concentrates, or studies of antiviral agents. One study of bleeding prophylaxis ('Clotting factor concentrates given to prevent bleeding and bleeding-related complications in people with haemophilia A and B') has been designed but is not yet completed, and another title ('Management of inhibitors with haemophilia A') has been registered. Some preliminary questions can establish areas where new clinical studies are needed.

Clinical Trials as Topic↗

PubMed2006

SuperNatural: a searchable database of available natural compounds.

Although tremendous effort has been put into synthetic libraries, most drugs on the market are still natural compounds or derivatives thereof. There are encyclopaedias of natural compounds, but the availability of these compounds is often unclear and catalogues from numerous suppliers have to be checked. To overcome these problems we have compiled a database of approximately 50,000 natural compounds from different suppliers. To enable efficient identification of the desired compounds, we have implemented substructure searches with typical templates. Starting points for in silico screenings are about 2500 well-known and classified natural compounds from a compendium that we have added. Possible medical applications can be ascertained via automatic searches for similar drugs in a free conformational drug database containing WHO indications. Furthermore, we have computed about three million conformers, which are deployed to account for the flexibilities of the compounds when the 3D superposition algorithm that we have developed is used. The SuperNatural Database is publicly available at http://bioinformatics.charite.de/supernatural. Viewing requires the free Chime-plugin from MDL (Chime) or Java2 Runtime Environment (MView), which is also necessary for using Marvin application for chemical drawing.

Anti-Infective Agents↗

PubMed2003

Mistletoe for cancer? A systematic review of randomised clinical trials.

Mistletoe extracts are widely used in the treatment of cancer. The results of clinical trials are however highly inconsistent. We therefore conducted a systematic review of all randomised clinical trials of this unconventional therapy. Eight databases were searched to identify all studies that met our inclusion/exclusion criteria. Data were independently validated and extracted by 2 authors and checked by the 3rd according to predefined criteria. Statistical pooling was not possible because of the heterogeneity of the primary studies. Therefore a narrative systematic review was conducted. Ten trials could be included. Most of the studies had considerable weaknesses in terms of study design, reporting or both. Some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

Clinical Trials as Topic↗

PubMed2005

Prognostic factors of response or failure of treatment in patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Français d'Immunothérapie.

Interleukin-2 (IL2) or/and interferon (IFN) are routinely used for treating patients with metastatic renal cell cancer. However, results are disappointing since most patients experience treatment failure. Within 6 years, the Groupe Français d'Immunothérapie enrolled 782 patients in successive multicenter trials using cytokine regimens. Univariate and multivariate analyses were performed on this large prospective database to identify prognostic factors for treatment response or failure. We identified two independent factors predictive of response to cytokine treatment: having only one metastatic organ site and receiving a combination of cytokine treatments. We also identified four independent factors predictive of rapid progression under treatment: presence of hepatic metastases, short interval from renal tumor to metastases (<1 year), more than one metastatic site and elevated neutrophil counts. Patients who combine at least three of these factors have over 80% probability of rapid progression despite treatment. We think that these results must be taken into account for cytokine treatment decision.

Adult↗

PubMed1990

Coordinating data management for multiple ongoing clinical trials and registries.

The Epidemiology Data Center at the University of Pittsburgh has developed a standard set of data management procedures, reports, and computing configurations for use on multicenter research projects. Based on budget restrictions and study design considerations, a project-specific data management system can be quickly constructed by utilizing appropriate components from the EDC tool kit: the PoP software system for the computerization of the database from paper forms to data entry screens; program shells for telecommunication and backup procedures; and procedural documents for providing the necessary training materials for centralized or decentralized processing environments. The EDC data flow specification provides quality control assurances from entry through statistical analysis.

Clinical Trials as Topic↗

PubMed2006

Management of respiration in MND/ALS patients: an evidence based review.

This systematic review comprises an objective appraisal of the evidence in regard to the management of respiration in patients with motor neuron disease (MND/ALS). Studies were identified through computerised searches of 32 databases. Internet searches of websites of drug companies and MND/ALS research web sites, 'snow balling' and hand searches were also employed to locate any unpublished study or other 'grey literature' on respiration and MND/ALS. Since management of MND/ALS involves a number of health professionals and care workers, searches were made across multiple disciplines. No time frame was imposed on the search in order to increase the probability of identifying all relevant studies, although there was a final limit of March 2005. Recommendations for patient and carer-based guidelines for the clinical management of respiration for MND/ALS patients are suggested on the basis of qualitative analyses of the available evidence. However, these recommendations are based on current evidence of best practice, which largely comprises observational research and clinical opinion. There is a clear need for further evidence, in particular randomised and non-randomised controlled trials on the effects of non-invasive ventilation and additional larger scale cohort studies on the issues of initial assessment of respiratory symptoms, and management and timing of interventions.

Amyotrophic Lateral Sclerosis↗

PubMed1996

[EDMUS--a new European databank for multiple sclerosis. A brief introduction of ongoing and planned multicenter studies within the scope of the "European Concentrated Action for Multiple Sclerosis"].

EDMUS, the European Database for Multiple Sclerosis (MS), was established on the occasion of the first European Concerted Action for MS under the auspices of the European Community. The system is user-friendly and makes it possible to record and retrieve data relevant to MS. Within the framework of another European Concerted Action, several international multicenter trials are currently in progress. EVALUED, a validation of the EDMUS system, assesses the interrater variability; PRIMS examines the influence of pregnancy and the post-partum period on the course of MS; and PRESTIMUS investigates predictive factors in suspected MS. Further, planned studies include ERAZMUS (early azathioprine and interferon-beta treatment in MS) and AZASTOP, which is designed to evaluate the effect of stopping azathioprine treatment.

Azathioprine↗

PubMed1999

DBcat: a catalog of biological databases.

The DBcat (http://www.infobiogen.fr/services/dbcat) is a comprehensive catalog of biological databases, maintained and curated on a daily basis at GIS Infobiogen. It contains more than 400 databases classified by application domains. The DBcat is a structured flat file library, that can be searched by means of an SRS server or a dedicated Web interface. The files are available for downloading from Infobiogen anonymous ftp server.

Biology↗

PubMed2001

A qualitative assessment of the neurological safety of antipsychotic drugs; an analysis of a risperidone database.

BACKGROUND: Neurological side effects of antipsychotic agents limit the use of these drugs, and development of newer antipsychotic agents has been focused on a reduced risk of extrapyramidal symptoms (EPS) as well as effective symptom control. METHODS: A qualitative analysis of EPS was performed using Extrapyramidal Symptom Rating Scale (ESRS) data from 11 double-blind risperidone trials. An ESRS factor analysis and maximum changes in ESRS scores were compared for the risperidone, haloperidol, and placebo groups. RESULTS: The factor analysis revealed five factors. Between-group comparisons showed no differences between placebo and 1 to 2 mg/day-risperidone groups. Parkinsonism, tremor, akathisia, and sialorrhea were more likely to occur with haloperidol than with placebo or risperidone at 1 to 6 mg/day. Similar results were noted by maximum changes in ESRS scores. At risperidone doses of more than 8 mg/day, acute EPS severity lay between that of the placebo and haloperidol groups. The severity of tardive dyskinesia was greater in patients receiving placebo than in those receiving either active treatment. CONCLUSIONS: As the results described above were derived from a post hoc analysis of an existing database, conclusions must remain tentative. To provide more definitive answers, EPS assessments in future studies should be refined to more accurately predict the type of EPS expected with a given agent in clinical practice.

Adolescent↗

PubMedDate not supplied

Practical management of patients with painful diabetic neuropathy.

PURPOSE: Painful diabetic neuropathy (PDN) has a significant impact on patients' quality of life, affecting sleep, mood, mobility, ability to work, interpersonal relationships, overall self-worth, and independence. The purpose of this article is to provide diabetes educators with current and essential tools for PDN assessment and management. METHODS: Medline and CINAHL database searches identified publications on the assessment and treatment of PDN. Identified research was evaluated, and information pertinent to diabetes educators was summarized. RESULTS: Recent advancements in assessment of neuropathic pain include identifying characteristics that distinguish between neuropathic and nonneuropathic pain. In the absence of treatment, research demonstrates that nerve damage may progress while pain diminishes. Many disease-modifying and symptom-management treatment options are available. CONCLUSION: Good glycemic control is the first priority for both prevention and management of PDN. However, even with good glycemic control, up to 20% of patients will develop PDN. PDN recognition and assessment are critical to optimize management. Although several treatment modalities are available, few patients obtain complete pain relief. Recent advances in understanding the mechanisms underlying neuropathic pain should lead to better treatment and patient outcomes. Combination therapy, including nonpharmacologic modalities, may be required. Research evaluating the efficacy of combination therapy is needed.

Acupuncture↗

PubMed2002

Evidence for physiotherapy practice: a survey of the Physiotherapy Evidence Database (PEDro).

Evidence-based practice involves the use of evidence from systematic reviews and randomised controlled trials, but the extent of this evidence in physiotherapy has not previously been surveyed. The aim of this survey is to describe the quantity and quality of randomised controlled trials and the quantity of systematic reviews relevant to physiotherapy. The Physiotherapy Evidence Database (PEDro) was searched. The quality of trials was assessed with the PEDro scale. The search identified a total of 2,376 randomised controlled trials and 332 systematic reviews. The first trial was published in 1955 and the first review was published in 1982. Since that time, the number of trials and reviews has grown exponentially. The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999. There is a substantial body of evidence about the effects of physiotherapy. However, there remains scope for improvements in the quality of the conduct and reporting of clinical trials.

Australia↗