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.
CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design.
The majority of newborns transition successfully from intrauterine to extrauterine life without any assistance. Less than 1% of all newborns will require extensive neonatal resuscitation involving chest compressions (CC) and medications at birth 1. Chest compressions are indicated for those newborns whose heart rate remains less than 60 beats per minute despite adequate ventilation 1. The American Heart Association (AHA) identifies two different methods of delivering chest compressions; a) the two-thumb (TT) method and b) the two-finger (TF) method. The two-thumb method is favoured by the AHA as it results in higher blood pressure and coronary perfusion pressures and can also be delivered from the head of the bed during umbilical catheter insertion 1. The quality of CC plays a vital role in delivering effective cardiopulmonary resuscitation (CPR). Solevag et al. report that high-quality CC requires (A) optimal compression:ventilation (C:V) ratio, (B) adequate CC rate, (C) depth of CC as well as (D) full recoil between compressions 2. The American Heart Association (AHA) recommend delivering chest compressions on the lower third of the sternum to a depth of one third the anterior-posterior (AP) chest diameter. The recommended C:V ratio is 3:1 (90 compressions and 30 breaths per minute) 1. A number of studies have highlighted the effects of rescuer fatigue on quality of chest compressions. One study reported adverse effects on CC quality when performed without interruption over a 3 minute period 6. It has therefore been recommended to rotate rescuers every 2-3 minutes in order to avoid rescuer fatigue and to ensure high quality CC6-7. As well as duration of CC, other factors can contribute to greater levels of rescuer fatigue. A number of studies have looked at the effect of different CC to ventilation methods on rescuer fatigue. Bodingh et al investigated this during simulated infant CPR. They reported greater levels of rescuer fatigue during simulated CPR in CCaV (continuous CC with asynchronous ventilation) at 120 CC per min compared to the recommended 3:1 C:V CPR 3. A similar study was performed by Li et al where rescuer fatigue was assessed during (i) 3:1 C:V ratio, (ii) CCaV at 90 CC per min and (iii) CCaV at 120 CC per min. However, unlike Bodingh et al, they found both 3:1 C:V and CCaV CPR to be equally fatiguing 4. Different CC techniques (TT vs TF method) can also cause varying levels of rescuer fatigue. In a recent study, Jiang et al compared the TT and TF chest compression techniques on infant mannequins and found that the TF method caused greater levels of rescuer fatigue compared with the TT method 5. We therefore set out to investigate whether different CC techniques cause different levels of rescuer fatigue during neonatal CPR. We hypothesize that performing TF method on neonatal mannequins will produce greater levels of rescuer fatigue. The results of this study would have significant implications in terms of choice of CC technique in new-born resuscitation. The purpose of this study is to compare rescuer fatigue during simulated neonatal chest compressions using two different CC methods; the two-finger (TF) method vs two-thumb (TT) method. This will be performed on both preterm and term mannequins by neonatologists and level of fatigue will be assessed by measuring change in cardiac output during chest compressions. Hypothesis: Performing CC using the two-finger (TF) method produces higher levels of rescuer fatigue compared with the two-thumb (TT) method during 5 minutes of simulated neonatal CPR.
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat.
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP) level implementation strategy to support delivery. The primary aim of CHErIsH pilot feasibility study is to collect and examine data on the acceptability and feasibility of the delivery of the brief infant-feeding intervention by HCPs to parents at child vaccination visits, and the strategy to support the implementation of this intervention in primary care for HCPs. Furthermore, half of all potential participants will be invited to provide maternal and infant biomarkers and/or take part in SWAT (study within a trial) which includes questions about infant feeding that were put together as part of a Core Outcome Set. These questions are important as they give a better understanding about what works and what doesn't. This will facilitate the refinement of the intervention and its implementation strategy, and inform the next step of the CHErIsH study, such as a definitive trial.
This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).
The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU). The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.