There are about 2333 clinical studies being (or have been) conducted in Ireland. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Rationale: Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias. Objective: To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.
The investigators hypothesized that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills. The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.
The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Heart attacks and strokes are common causes of death worldwide. These events occur in part, due to increased activity of platelets, which cause clotting (thrombosis) within heart and brain blood vessels. Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and therefore protect against heart attacks and strokes. However serious bleeding into the gut and brain occurs in a number of individuals prescribed aspirin. Currently, there is no reliable method for assessing the relative risks of thrombosis versus bleeding in individual patients prior to or during aspirin therapy. We have recently discovered that individuals with a particular genetic make-up, those with genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky) platelets. We then found that these same individuals suffered a greater number of cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet stickiness and protected against heart attacks and strokes in these patients. In this project, we aim to confirm and extend the above findings. We hope that testing for PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but not suffer any bleeding complications.
Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS) - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS). - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
The study will be completed as a two part, prospective, single-centre, randomised controlled trial. Five volunteers (dentists) will be recruited in the first part of the study to evaluate and examine the microneedle device and its use. Based on those qualitative findings (individual interviews and focus group) modifications to the microneedle device will be implemented before part two of the study commences. Twenty volunteers will be enrolled in the second part of the study. A split mouth design will be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local dental anaesthetic solution. Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded and compared.
This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with newly diagnosed Multiple Myeloma (MM) will be treated with Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA). The safety profile of daratumumab to date, which does not appear to overlap with those known for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of daratumumab combined with various backbone regimens may improve the treatment effect of these regimens. Additionally, daratumumab as a single agent may prolong the progression free interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP, there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing regimen. This will be the first clinical trial to explore the feasibility of combining daratumumab with a cyclophosphamide containing backbone induction regimen and if successful will provide the rationale for larger studies exploring the efficacy of this combination in greater detail.
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.