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 is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses
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.
A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active. This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.