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.
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring >48 hours of age). In Canada, ~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these ~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices. Aim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS. Objective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS. Hypothesis: Primary treatment with NE will be associated with a lower mortality Methods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 15 centers in Canada, 4 centers in Ireland, 2 centers in Israel and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc/kg). If hypotension remains unresolved: Dopamine Units: start at 5mics/kg/min, increase every 16-30 minutes by 5 mics/kg/min to a maximum dose of 15 mics/kg/min or adequate response Norepinephrine Units: start at 0.05 mics/kg/min, increase every 16-30 minutes by 0.05 mics/kg/min to maximum dose of 0.15/mics/kg/min or adequate response
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, < 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in >60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action. The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
The present study seeks to build on these observations to assess whether in principle, fat containing microcapsules might help patients experiencing constipation in association with weight loss interventions (including GLP-1 analogues or bariatric surgery) to both avoid/treat constipation and simultaneously optimise their ability to feel full during eating. This potential dual action may provide added benefit versus the use of traditional approaches to constipation prophylaxis e.g., lactulose.
This study is designed as a prospective, double-blind, placebo-controlled, randomized parallel-group study that will be completed at the clinical research facility at St. James' Hospital and at Trinity College Dublin, Ireland. A total of 100 amnestic mild cognitive impairment (aMCI) patients will receive a (real or control) non-invasive transcutaneous electrical stimulation procedure. Patients will be assigned to one of four groups. One group will receive active stimulation, while the three groups will be control groups. One groups will be receive sham stimulation (inactive control), while a second group will receive active stimulation and local anesthesia and a third group will stimulate a different nerve (active control; same sensation different nerve). The investigators will include three control groups to verify that the effect is real and location specific and cannot be associated to a sensation effect. The investigators have opted to use a parallel-group design as it is unclear what the carry-over effect and/or wash-out period will be for stimulation. To eliminate subjective bias, all patients and the investigator testing the endpoint measures will be blinded to the type of intervention. The primary outcome, i.e. memory recall, will be determined by a word association task recorded immediately after stimulation, 7 days after stimulation, and 28 days after stimulation. The secondary outcomes is neurophysiological changes determined by resting state EEG, which will be assessed immediately before and after stimulation in the first session. The investigators will conduct this study as follows: 1. Screening aMCI patients. 2. Randomly assigning aMCI patients to one of the four groups. 3. Administering one session active stimulation (n = 25) or control (n = 25 in each of three control group) stimulation paired with a word-association task; administered by research assistant. 4. Behavioral assessments after each of the three blocks of studying the word associations and neural measures immediately after the last session of Behavioral assessments (T0). 5. Behavioral assessments at seven (T1) and 28 (T2) days after stimulation.
To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.
Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS). Serum testosterone correlates with insulin resistance in PCOS, however, there is an urgent need to improve our understanding of the association between androgens and the risk of type 2 diabetes. 11-oxygenated steroids are the predominant androgens in PCOS and correlate closely with markers of insulin resistance. The bioactive 11-oxygenated androgen 11-ketotestosterone (11KT) binds and activates the androgen receptor with equal affinity to testosterone, yet nothing is known about its impact on metabolism or glucose homeostasis Crucially, there are no data linking androgen excess with muscle glucose metabolism and the differential contribution of 11-oxygenated androgens to diabetes risk through these processes remains unknown. The investigators hypothesise the following: 1. Oral androgen exposure in women with PCOS results in distinct changes in tissue-specific insulin sensitivity and muscle energy biogenesis 2. 11-oxygenated androgen exposure exerts differential changes on the above parameters in comparison to classic androgen exposure The study has the following aims: 1. To examine the impact of oral androgen exposure on skeletal muscle insulin sensitivity and glucose disposal in women with PCOS. 2. To delineate the impact of androgen exposure on muscle mitochondrial function ex vivo in women with PCOS 3. To compare the differential impact of 11-oxygenated androgen compared to classic androgens on glucose disposal and muscle mitochondrial function The two arms will run in parallel and all participants will undergo identical investigations before and after 7 days of either DHEA or 11KA4. Investigations will include baseline arthrometric measurements muscle biopsy, two-step hyperinsulinaemic euglycaemic clamp, breath sampling. This interventional metabolic phenotyping study will probe the role of classic and 11-oxygenated androgens in metabolic dysfunction in PCOS using gold-standard in vivo metabolic phenotyping techniques. Delineating the distinct contribution of 11-oxygenated androgens, through effects on skeletal muscle biology, to the risk of T2DM is an important step in the process of determining risk of type 2 diabetes in this vulnerable cohort.
Malnutrition and reduced muscle mass have been associated with poor outcomes in many disease conditions including severe inflammatory bowel disease, liver failure and cancers. Studies have shown that use of an amino acid supplement can specifically support muscle and nutritional health of patients with liver cirrhosis and malnutrition in general. The investigators will perform new novel non-invasive measurements of muscle mass and strength as well as inflammatory markers and record food diaries in the investigators patients with inflammatory bowel disease, cirrhosis of the liver and other gastroenterology disease impacting patient nutrition. The investigators hope to determine if of the addition of BCAA in addition to best practice nutrition supports for patients with cirrhosis will improve muscle mass and clinical outcomes in the investigators patient cohort including hospitalization, rate of decompensations, frailty score and quality of life for patients with liver cirrhosis. The investigators intend to investigate whether immune-metabolic profiles, circulating T-cells and circulating plasma cytokines (Afzal et al, J. Clin. Med. 2020) may act as biomarkers in combination with non-invasive novel markers of muscle mass in patients with chronic gastrointestinal illness, particularly cirrhosis to predict outcomes, and whether implementation of best practice nutritional supports with addition of Amino MP9 supplementation may impact functional outcomes. The immunometabolic profiles of these cohorts in relation to macrophage and T Cell function and differentiation have not been described previously. The investigators also hope to develop a system facilitating accurate assessments of nutritional status in gastroenterology patients and determine if there is correlation with objective clinical activity measured using endoscopy, faecal calprotectin or radiological evidence of inflammation, currently measured as part of standard practice. Sub-analysis will investigate potential association between longitudinal diet evaluation using EDIP (empirical dietary inflammatory pattern) score and disease activity, clinical remission and response to medical therapy, all influencing quality of life and patient related outcome measures. A prospective observational analysis of nutritional status and muscle mass or sarcopenia in patients attending gastroenterology services at Beaumont Hospital. Patients will be recruited from Gastroenterology and Hepatology outpatient clinics or inpatient capacity. Controls will be recruited from outpatient setting.
The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax. The characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.