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.
This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) [+digital weighing scales & BP monitor] on outcomes in ambulatory haemodialysis patients. Design: prospective, open-label, random order, sham-controlled, two-period crossover comparison of the pMp app [+digital weighing scales & BP monitor] compared with a sham application (without weighing scales or BP monitor). Duration: 10 weeks (usual care run-in for 2 weeks followed by 2 x 4 observation periods). Primary objective is to determine the frequency of use of the pMp app [+digital weighing scales & BP monitor] in patients randomized to that observation method. Additional objectives are to determine the effect of pMp app [+digital weighing scales & BP monitor] on proportion of haemodialysis sessions in which ultrafiltration rate is ≤ 10 mL/kg/h and in which interdialytic weight gain (IDWG) is ≤ 4% and effect of pMp on pre-dialysis weight and BP, medication adherence, compliance with daily recording (of fluid intake, weight, BP) and requirement for additional unscheduled dialysis. An additional objective is to assess the acceptability and utility of the pMp app in helping hemodialysis patients and their healthcare professional caregivers manage their condition (assessed from both patient and healthcare professional perspective).
It is well known that sleep is essential for brain development and learning. Infants require extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for optimizing physical growth. It is also essential for brain plasticity; the genetically determined ability of the infant brain to change its structure and function in response to the environment. Studies in young animals have shown that sleep deprivation leads to increased programmed cell death, smaller brain size, and loss of brain plasticity, all of which have negative long-term impact on behaviour and learning ability. Infant massage, a form of systematic tactile stimulation by human hands, improves sleep hygiene. Very little is known about how massage influences early brain development but it is certainly linked to the theory of environmental enrichment, which has been well established in animal models. The aim of this project is to optimise the infant's sensory experience through a multi-sensory enrichment programme, including massage (a massage utilising a scented lotion before sleep each day), to encourage more structured sleep and ultimately show improved developmental and cognitive outcomes.
Extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal calculi. Standard of care involves offering oral analgesia prior to commencing the treatment. Most patients do not take the offered analgesia after the initial treatment. It has been suggested that distraction techniques may be equivalent to oral analgesia in improving tolerability of extracorporeal shockwave lithotripsy treatment. The use of distraction techniques also removes the potential side effects of mediation administration.
The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.
This study is a secondary analysis of the dietary, phenotypic and demographic data collected within the National Adult Nutrition Survey (NANS), Ireland, to determine meal patterns using a variety of statistical methods.
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.
Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.