Search results for " trials"

Factors influencing inclusion in digestive cancer clinical trials: A population-based study

2015

Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy.To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials.Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.Patients aged over 75 years were significantly less likely to be included in clinical trials …

Psychotropic Drugs in the Management of Chronic Pain Syndromes

1993

Psychotropic drugs have been integrated into the management of chronic pain syndromes for more than 30 years. Numerous open and controlled studies have taken place evaluating especially the antinociceptive efficacy of antidepressive drugs. This survey comprises the results of clinical reports, open clinical studies, placebo-controlled studies, and comparative studies of different substances. It will be shown that antidepressants are by far the best evaluated psychopharmacological substances, showing superiority against placebo in 70% of a total of 67 placebo-controlled studies. The synopsis of controlled comparison studies of different antidepressants tends to demonstrate a superiority of c…

Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA(2)LEN taskforce position paper

2010

The GA(2)LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patient-related factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaini…

Fighting the bushfire in HCC trials

2011

Adaptive trial design: a general methodology for censored time to event data.

2008

Adaptive designs allow a clinical trial design to be changed according to interim findings without inflating type I error. The Inverse Normal method can be considered as an adaptive generalization of classical group sequential designs. The use of the Inverse Normal method for censored survival data was demonstrated only for the logrank statistic. However, the logrank statistic is inefficient in the presence of nuisance covariates affecting survival. We demonstrate, how the Inverse Normal method can be applied to Cox regression analysis. The required independence between test statistics of the different stages of the trial can be obtained by two different approaches. One is using the indepen…

Thoughts of a reviewer

1990

Oral Glycoprotein IIb/IIa Antagonists for Unstable Angina — Is There Still a Chance for the Oral Substances?

2001

The intravenous glycoprotein IIb/IIIa antagonists abciximab, tirofiban and eptifibatide are well accepted for the therapy of patients with unstable angina and/or as concomitant medication during coronary interventions. Despite the fact that these drugs are not used in all patients presenting with unstable angina during coronary interventions, the scientific evidence is overwhelming including the substantial reduction in mortality 3 years after utilisation of abciximab for coronary interventions in patients with unstable angina. In addition to these two indications, intravenous glycoprotein IIb/IIIa antagonists are currently being investigated for use in patients undergoing carotid artery in…

Possible clinical usefulness of embryonic stem cells

2012

Abstract Are embryonic stem cells being used for therapeutic purposes? The aim of this short report is to review to what extent are embryonic stem cells currently used for therapeutic purposes. To the best of our knowledge, only four clinical trials have been authorised so far to use human embryonic stem cells for therapeutic purposes; two of these are included in the ClinicalTrials.gov data base, and the other two, the study sponsored by Geron and the last one initiated by Advanced Cell Technology in the United Kingdom, are not. But, in addition, Geron withdrew the clinical trial which had been originally proposed by the company itself. This brief review focuses the debate on the use of em…

Almotriptan: meeting today’s needs in acute migraine treatment

2007

Migraine is a common disorder associated with considerable individual and economic burden. Triptans are recommended for the treatment of migraine of any severity in patients who have failed to gain adequate relief with nonspecific medication; early transition to triptans avoids prolonged morbidity in patients failing to respond to nonspecific medications. There is evidence that early intervention therapy with oral formulations in migraine, soon after the onset of an attack and when pain is still mild, improves efficacy. Seven different triptans are currently marketed, with differing pharmacologic, efficacy and tolerability profiles. Almotriptan has many positive features, which include rigo…

Efficacy and safety of cyclic pyranopterin monophosphate substitution in severe molybdenum cofactor deficiency type A: a prospective cohort study.

2015

Summary Background Molybdenum cofactor deficiency (MoCD) is characterised by early, rapidly progressive postnatal encephalopathy and intractable seizures, leading to severe disability and early death. Previous treatment attempts have been unsuccessful. After a pioneering single treatment we now report the outcome of the complete first cohort of patients receiving substitution treatment with cyclic pyranopterin monophosphate (cPMP), a biosynthetic precursor of the cofactor. Methods In this observational prospective cohort study, newborn babies with clinical and biochemical evidence of MoCD were admitted to a compassionate-use programme at the request of their treating physicians. Intravenous…