Search results for "CLINICAL TRIALS"
showing 10 items of 490 documents
Treatment of Venous Thromboembolism in Special Populations with Direct Oral Anticoagulants
2020
AbstractAs a result of the successful completion of their respective phase III studies compared with vitamin K antagonists (VKAs), four direct oral anticoagulants (DOACs) have been approved for the treatment and secondary prevention of venous thromboembolism (VTE). These DOACs—apixaban, dabigatran, edoxaban, and rivaroxaban—have subsequently seen a steady uptake among clinicians since their approval. Despite the suitability of DOACs for a broad range of patients, they are not appropriate in certain situations, whereas in others they require additional considerations such as dose reductions. Subanalyses of phase III trials and studies on specific VTE patient populations have been conducted t…
Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy
2016
Lymphoid organs, in which antigen presenting cells (APCs) are in close proximity to T cells, are the ideal microenvironment for efficient priming and amplification of T-cell responses. However, the systemic delivery of vaccine antigens into dendritic cells (DCs) is hampered by various technical challenges. Here we show that DCs can be targeted precisely and effectively in vivo using intravenously administered RNA-lipoplexes (RNA-LPX) based on well-known lipid carriers by optimally adjusting net charge, without the need for functionalization of particles with molecular ligands. The LPX protects RNA from extracellular ribonucleases and mediates its efficient uptake and expression of the encod…
Mediterranean Diet and atherothrombosis biomarkers: a randomized controlled trial
2020
Scope To assess whether following a Mediterranean diet (MedDiet) improves atherothrombosis biomarkers in high cardiovascular risk individuals. Methods and results In 358 random volunteers from the PREvención con DIeta MEDiterránea trial, the 1‐year effects on atherothrombosis markers of an intervention with MedDiet, enriched with virgin olive oil (MedDiet‐VOO; n = 120) or nuts (MedDiet‐Nuts; n = 119) versus a low‐fat control diet (n = 119), and whether large increments in MedDiet adherence (≥3 score points, versus compliance decreases) and intake changes in key food items are associated with 1‐year differences in biomarkers. Differences are observed between 1‐year changes in the MedDiet‐VOO…
Mediterranean Diet Maintained Platelet Count within a Healthy Range and Decreased Thrombocytopenia-Related Mortality Risk: A Randomized Controlled Tr…
2021
There is little information on the dietary modulation of thrombosis-related risk factors such as platelet count. We aimed to assess the effects of Mediterranean diet (MedDiet) on platelet count and related outcomes in an older population at high cardiovascular risk. In participants of the PREDIMED (PREvención con DIeta MEDiterránea) study, we assessed whether an intervention with a MedDiet enriched with extra-virgin olive oil or nuts, relative to a low-fat control diet, modulated platelet count (n = 4189), the risk of developing thrombocytosis and thrombocytopenia (n = 3086), and the association between these alterations and all-cause mortality (median follow-up time: 3.0 years). Although p…
Session 2: Are we ready for primary chemotherapy in rectal cancer: who, when, why?
2018
The potential of preoperative chemotherapy in rectal cancer is the subject of investigation in a number of global randomized trials. In this overview and expert discussion, Professor Cervantes summarizes the findings of numerous Phase II trials testing neoadjuvant chemotherapy. The crucial points in the next phase of trials include: patient selection, whether radiotherapy can be omitted altogether and whether chemotherapy can be used to augment the initial response to chemoradiotherapy. Finally, with the emergence of Magnetic Resonance Tumour Regression Grade a reliable method for assessing response after initial chemoradiotherapy, we ask if this can be used to drive the use of further sele…
Sample size planning of two-arm superiority and noninferiority survival studies with discrete follow-up
2016
In clinical trials using lifetime as primary outcome variable, it is more the rule than the exception that even for patients who are failing in the course of the study, survival time does not become known exactly since follow-up takes place according to a restricted schedule with fixed, possibly long intervals between successive visits. In practice, the discreteness of the data obtained under such circumstances is plainly ignored both in data analysis and in sample size planning of survival time studies. As a framework for analyzing the impact of making no difference between continuous and discrete recording of failure times, we use a scenario in which the partially observed times are assig…
Improve hip fracture outcome in the elderly patient (iHOPE) : A study protocol for a pragmatic, multicentre randomised controlled trial to test the e…
2018
IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner aft…
Treatment of irritable bowel syndrome with probiotics. An etiopathogenic approach at last?
2009
Irritable bowel syndrome (IBS) is the most common functional digestive disorder, and may affect 11-20% of the adult population in industrialized countries. In accordance with Rome III criteria (2006) IBS involves abdominal pain and bowel habit disturbance, which are not explained by structural or biochemical abnormalities. Several hypotheses attempt to account for the pathophysiology of IBS, but the etiology still remains uncertain or obscure, perhaps multifactorial. Abnormalities in colonic microflora have recently been suggested in such patients, as has abnormal small-intestine bacterial overgrowth (SIBO), or in particular a significant reduction in the amount of intraluminal Bifidobacter…
Intraocular Pressure Telemetry for Managing Glaucoma during the COVID-19 Pandemic
2021
Purpose To evaluate in glaucoma patients the feasibility and use of remote monitoring of intraocular pressure (IOP) with an implanted telemetry sensor during the coronavirus disease 2019 (COVID-19) lockdown. Design Cross-sectional study. Participants Patients previously implanted with a telemetric IOP sensor (Eyemate; Implandata GmbH) were included. Methods Intraocular pressure measurements acquired by the patients during the lockdown were collected by physicians who were located remotely. A questionnaire was sent to 10 participating study centers to evaluate the clinical impact of remote monitoring of IOP via the IOP sensor system. Main Outcome Measures Number of patients who obtained home…
External validity of randomized controlled trials in older adults, a systematic review.
2017
Background To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics. Methods PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected tri…