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Results for “Clinical Trials, Phase IV as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 109 records · Page 6Linked to original sources
PubMed2002

Abciximab readministration.

The IIb/IIIa receptor inhibitors have been shown to improve outcomes following percutaneous coronary intervention (PCI), particularly by decreasing periprocedural myocardial necrosis. Abciximab has been subject to multiple studies, demonstrating consistent improved early and late outcomes in multiple patient populations, including a mortality advantage in diabetics, but there has been concern about the possibility of anaphylaxis, thrombocytopenia, and reduced clinical efficacy with repeat administration of abciximab. Results of the ReoPro Readministration Registry, a prospective, phase IV, multicenter registry of 500 patients undergoing PCI who were treated with abciximab at least 7 days after a previous treatment with this same drug, support the contention that abciximab readministration is both safe and clinically efficacious and that there is no significant increase in the incidence of thrombocytopenia as compared with historical controls of trials of first abciximab administration. However, profound thrombocytopenia did occur with increased frequency as compared with historical controls, suggesting a shift from mild to profound thrombocytopenia with abciximab readministration.

Abciximab↗
PubMed1998

Combination therapy for patients with HIV-1 infection: the use of dual nucleoside analogues with protease inhibitors and other agents.

This report reviews the design and preliminary results of ongoing and new studies that are evaluating novel antiretroviral drug combinations for the treatment of patients with HIV-1 infection. The studies reviewed in this report are: (1) Selection of Thymidine Analogue Regimen Therapy (START) I and II which compare three-drug combinations of stavudine (d4T), lamivudine (3TC), and indinavir, or d4T, didanosine (ddI), and indinavir versus zidovudine (ZDV), 3TC, and indinavir; (2) ATLANTIC, a study that compares d4T and didanosine (ddI) in combination with a third agent, either 3TC, nevirapine, or indinavir; and (3) the OZCOMBO studies: OZCOMBO 1, which compares two-drug combinations of d4T and 3TC, d4T and ddI, and ZDV and 3TC, all in combination with indinavir, and OZCOMBO 2, which compares two-drug combinations of d4T and ddI, ZDV and ddI, and ZDV and 3TC, all in combination with nevirapine. Preliminary results from these studies suggest that novel dual-nucleoside analogue reverse transcriptase inhibitor pairs, d4T and 3TC, d4T and ddI, and ZDV and ddI, as part of three-drug combinations, achieve antiretroviral effects comparable to ZDV- and 3TC-based three-drug combination regimens.

Anti-HIV Agents↗
PubMed2005

[Funtional phase IV?].

Explore the source record for details and available documents.

Clinical Trials, Phase IV as Topic↗
PubMedDate not supplied

[Methodological analysis of phase IV clinical trials performed in hospital based on the Huriet Law ].

Since the implementation of the 'Huriet law', drugs in phase IV clinical trials are handled by the pharmaceutical Department of the 'Hôpital Neuro-Cardiologique' (Lyon, France). The methodology of these trials is assessed by using a special assessment grid which enables a score for each protocol, with a maximal score of 20 and a minimal one of minus 20. Although many limitations could be advanced, results of this study show that, among 39 assessed trials, 13 trials had weak methodology (score < or = 0), 16 are middle-quality trials (score between 0 and 10) whereas 10 trials only can be considered as having a strong methodology (score > 10). So, a fairly large number of the organized phase IV trials have debatable quality. Moreover, their objective is questionable, that is essentially promotional, in spite of the 'Huriet law' and Persons Protection Committees.

Clinical Trials, Phase IV as Topic↗
PubMed1996

The nurse's role in clinical trials.

Parkinson's disease (PD) is a chronic and progressive degenerative disorder of the central nervous system characterized by tremor, rigidity, slowness of movement (bradykinesia) and postural abnormalities. The cause is unknown, but the pathology shows that dopamine is profoundly reduced in the basal ganglia of patients with PD. When dopamine is replenished by the administration of levodopa, most of the symptoms of parkinsonism are reduced significantly. Levodopa is considered to be the most reliable and effective symptomatic drug treatment for keeping patients autonomous and functionally independent for as long as possible.

Antiparkinson Agents↗
PubMed1998

[Ethics problems in phase IV of drug studies].

Phase IV clinical studies include all investigations carried out after the approval of drugs. The objective of these studies is well defined: to gain additional knowledge on efficacy and safety of drugs. There are uncertainties however with regard to which kind of study design is appropriate to provide scientifically valid contributions. In the present article we will clarify why an experimental design (e.g. randomized clinical trial) is ordinarily required, on the basis of scientific and ethical concerns, to answer questions concerning efficacy even after drug commercialization. Viceversa, non experimental designs (from case series analysis to cohort and case control studies) are indicated to investigate drug effects in current practice if the objective is to evaluate safety.

Clinical Trials, Phase IV as Topic↗
PubMed2002

Complexities in ETS-domain transcription factor function and regulation: lessons from the TCF (ternary complex factor) subfamily. The Colworth Medal Lecture.

The ETS-domain transcription factor family can be divided into a series of subfamilies. Elk-1 represents the founding member of the ternary complex factor (TCF) subfamily. By focusing on the TCF subfamily, we can demonstrate the complexities that exist in the function and regulation of ETS-domain transcription factors. This article focuses on Elk-1 in detail and summarizes the functions of other TCFs. The key themes covered include the domain structure of the TCFs, the mechanisms of complex formation with serum response factor, regulation of TCFs by mitogen-activated protein kinase cascades, and transcriptional regulatory properties of the TCFs. Finally, the emerging role of the TCFs in vivo is discussed. A picture is developing indicating that, while these proteins exhibit significant sequence and functional conservation, key differences in their structure and regulation are being identified which may relate to unique functions of these proteins in vivo.

Amino Acid Sequence↗