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.
The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the cut-off date at a MAP site. The study cut-off date was 09-Mar-2020. Patient-level data were abstracted from medical charts of all eligible patients at all participating sites. Study completion date refers to the last date data was extracted. Information from patients treated with alpelisib was used to describe the efficacy and safety of alpelisib in PROS patients.
Object: To determine the Knowledge about anaesthesiologist's role and responsibilities along with the field of anaesthesiology among patients. Study Design: A Cross-Sectional Survey. Place and Duration of Study: National Guard Health Affairs, from 1st December 2017 to 30th March 2018. Methodology: After informed consent patients were asked to answer the questionnaire comprising of 12 open-ended questions regarding their knowledge about anaesthesiologist and anaesthesiology. Scoring as per correct and incorrect questions was done using version 19 (SPSS Inc., Chicago, IL).
This intervention trial explores the feasibility, effectiveness and acceptability of a novel psycho-social intervention for early psychosis based on a combined cognitive remediation training and cognitive behavioural therapy approach focused on social recovery. The impact of the CReSt-R intervention on social cognition as a primary outcome will be explored in addition to secondary outcome measures such as social and occupational functioning ( Detailed further in this registration). Feasibility of the trial design and the acceptability of the CReSt-R intervention to the target group, 16-35 year olds who are within the first 5 years of a diagnosed psychotic illness, are also explored in this trial.
Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.
GEMMA is a multicenter longitudinal observational study that follows children who are genetically at-risk of developing autism for their first three years of life, seeking to identify potential biomarkers predictive of autism development in the blood, stool, urine and saliva. The biomarkers identified in this project will contribute to a better understanding of the pathogenesis of ASD in at-risk children and possible solutions for alleviating and/or preventing ASD and ASD-related symptoms in patients in the future.
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.
Primary Objectives: - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survival Other Secondary Objectives: To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)
Chronic Obstructive Pulmonary Disease (COPD) is a pervasive, insidious condition associated with catastrophic socioeconomic, healthcare and personal implications. This proposal outlines how a group singing intervention, led by clinical personnel and a community singing leader, can address these challenges. Built upon existing ties between the Principal Investigator (PI) and local COPD support group, this project is co-designed by patients and clinicians. Modelled on similar interventions internationally, this project is pioneering in Ireland. Outputs will include a participant-led symposium and three community COPD choirs, in addition to a number of academic publications. This project is funded by the Irish Research Council (IRC) "New Foundations" scheme.
The MEDRA study is a 12-week randomised controlled trial that aims to assess effects of a Mediterranean dietary telehealth intervention compared to the Irish Healthy Eating guidelines on the physical function and quality of life of adults living with Rheumatoid Arthritis in Ireland. Investigators will be able to determine how closely people living in Ireland can accept the Mediterranean dietary practices and adhere to them with dietetic input and guidance.
Lactobacillus gasseri BNR17™ has shown promise in several pre-clinical and randomized controlled clinical trials for weight management outcomes. The current randomized, double-blind, placebo-controlled, parallel-arm trial will further assess L. gasseri BNR17™ on body composition and weight management, and in a study population that is distinct to prior randomized controlled trials on the strain. The study will recruit 126 overweight adult participants who will be randomly assigned to consume L. gasseri BNR17™ or placebo once daily for 12 weeks.