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.
In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy. The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible. The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.
The aim of this study is to evaluate the effectiveness of a combined Exercise and Acceptance and Commitment Therapy (ACT) programme, compared to a standalone supervised exercise intervention for patients with chronic pain. Chronic pain is a common problem, which can have a significant impact on quality of life. While there are many treatments available for chronic pain, research has shown that improvements are often modest and short-term. Exercise therapy is known to be helpful for many chronic conditions and is recommended in clinical guidelines for the management of chronic pain. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy, which focuses on improvement of function, rather than symptom reduction. There is an emphasis on psychological flexibility, values and mindfulness. This approach may be well suited to chronic pain, where symptoms can be beyond a person's control, but there is a need for further research, particularly with regards to combining ACT with a physical intervention. This study will take place in a Dublin University hospital. Patients will be randomly allocated to a combined exercise and ACT treatment group or a standalone exercise group. Both groups will have weekly treatment for eight weeks and will be assessed before and after treatment, and again twelve weeks later. Questionnaires will be used to measure the effects of the treatment on the degree to which pain interferes with various aspects of daily life. Activity trackers will be worn to measure daily physical activity levels. A purposeful sample of participants from both groups will also be invited to participate in a qualitative study following treatment.
This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor. Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.
- To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects - To select 1 MR formulation for use in fed state - To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation
Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress
This trial is a single-site, randomised, double blind, placebo-controlled, two-armed parallel-group trial in healthy adult volunteers. The trial will investigate the effect of oral supplementation of a probiotic strain on the ability to attenuate exercise-induced deterioration of intestinal barrier function and gastrointestinal symptoms.
In this proposed study, the investigators are looking to conduct a prospective, randomised, double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks versus continuous local anaesthetic infusion analgesia versus a combination of PECs blocks and local anaesthetic infusion analgesia, when it comes to providing analgesia for most forms of breast surgery. Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are growing in popularity, as they reduce the amount of opioid medications used. Opioids are associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as such, opioid-sparing analgesic regimens postoperatively are becoming more common. These regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug), and a local anaesthetic technique. Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations within the chest wall, typically done after the patient undergoes general anaesthesia, but before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion of a catheter into the wound at the end of surgery, before the patient emerges from general anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each technique is considered extremely safe, and is considered acceptable as a form of pain relief in patients undergoing breast surgery. There are no published works comparing pectoral plane blocks with local anaesthetic infusion pump analgesia, and the investigators see a gap in the knowledge base that can be addressed. This study will allow efficacy, safety and cost of the three techniques to be compared. The investigators feel the study design is robust, and statistical analysis based on previously published works in the area of postoperative analgesia has allowed the study to be powered appropriately. Patients undergoing breast surgery are a vulnerable group, and this is recognised via the provision of a comprehensive Patient Information Leaflet and a commitment to respecting the process of Informed Consent. The investigators also recognise this is a stressful period in a woman's life, and the study will be conducted in a sensitive and compassionate manner. The study has been designed to be prospective, randomised, and double-blinded. The anaesthetic will be standardised in relation to analgesic and anti-emetic agents administered, in order to minimise variables. Chronic post-surgical pain is a growing area of research, and the follow-up telephone interview at 3-months will allow investigation of this. A Data Record Form will be utilised for data collection, which will subsequently be analysed statistically. Data will be handled sensitively, securely, and by the minimum number of researchers. A plan is in place for destruction of data at an appropriate time. While there will be no direct benefit to participants, including monetary considerations, this research study will add to the knowledge-base surrounding analgesia for breast surgery.
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.
This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. * The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.