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.
Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.
High uptake is vital to population-based screening. BowelScreen (Irelands national organised population-based colorectal cancer screening programme) has not achieved recommended screening uptake targets. In Ireland sending the test kit in the screening invitation reminder may be an important strategy in targeting non-responders and would address a key difference between Ireland and other international screening programmes with higher uptake. In addition, few studies have focused on behavioural barriers to screening participation. Founded upon the MRC Guidelines for the Development of Complex Interventions, our systematic, theoretically-informed investigation of FIT screening participation has begun to identify behavioural antecedents to screening participation in Ireland. This study will implement a multilevel evidence-based, theoretically-informed intervention which includes the automatic inclusion of the test kit in the screening reminder, alone and in combination with an intervention to influence individuals' screening participation. This multilevel intervention will provide recommendations for the screening invitation delivery, potentially bringing the programme closer to recommended uptake targets (50%) and in the long-term influence reductions in bowel cancer incidence and mortality in Ireland.
The APPETITE Trial aims to investigate the efficacy of innovative plant protein fibre (PPF) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three European countries at high risk of undernutrition.
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs. - How much study drug is in the blood at different times. - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life.
Despite recent advances in acute stroke intervention, secondary prevention strategies are lacking. Physical activity (PA) is the second largest predictor of stroke and the cornerstone of secondary prevention therapies. Adaptive interventions involve sequential treatments responsive to individuals' performance. Despite guidelines to adapt PA to individuals' needs, there is no evidence on the empirical development of adaptive PA interventions post-stroke. The evidence is dominated by standard trial designs, used to evaluate non-adaptive PA interventions. This trial will make original contributions to the literature by designing a first-in-class adaptive PA intervention using an innovative experimental design. This design will permit the delivery of optimal sequences of treatments to increase PA for individuals. Furthermore, by developing a user-informed smartphone application, this feasibility trial will lead to the design and evaluation of a highly-scalable definitive intervention to reduce the risk of recurrent stroke. Aim To use a Sequential Multiple-Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mobile health (mHealth) intervention to improve PA post-stroke. Subsequently this adaptive intervention will be evaluated against a treatment-as-usual control using a standard trial design in a definitive trial. Methods A co-design process was used to develop the technology platform for intervention delivery. There are two components which target increased PA in the current intervention: Structured Exercise and Lifestyle PA. The SMART will determine what sequence and/or combination of these intervention components produces the greatest increase in physical activity as measured by average daily step count. The primary outcome will be PA (steps/day), with clear feasibility and secondary clinical and cost outcomes. A SMART design will be used to evaluate the optimum adaptive PA intervention among people post-mild-to-moderate stroke.
Recent studies have shown that many vitamins, if consumed in high daily dosages or delivered to the colon, can modulate the gut microbiota and their metabolites. In parallel, gut microbiota imbalances are linked to diseases, e.g., obesity, type 2 diabetes, cardiovascular disease, autoimmune diseases, and intestinal inflammatory diseases. Therefore, vitamin administration could offer health benefits beyond those traditionally considered for these nutrients. Earlier, our group investigated the effect of colon-delivered vitamins A, B2, C, D, and E on the gut microbiota using a human clinical trial and showed that vitamin C, B2, and D modulates the human gut microbiome in terms of metabolic activity and bacterial composition. The most distinct effect was that of vitamin C, which significantly increased microbial alpha diversity and fecal short-chain fatty acids compared to the placebo. However, the dose-dependent and combined effect of colon-delivered vitamins on the microbial community and its subsequent impact on host health is unknown. This study will investigate the effect of colon-delivered vitamin C (three dosages) on the gut microbiome.
The purpose of this clinical trial is to evaluate efficacy and safety of once weekly SC doses of 100 µg CNP/kg compared to placebo on Annualized Growth Velocity after a 52-week randomized treatment period in children aged 2 to 11 years with genetically confirmed Achondroplasia. The double-blind, placebo-controlled treatment period is followed by an Open Label Extension (OLE) period of a 52-week duration.
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: - record information about their hot flashes - answer questions about their quality of life and other symptoms. The doctors and their study team will: - check the participants health and vital signs - take blood and urine samples - examine heart health using electrocardiogram (ECG) - examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs - make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) - check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) - take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. - ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.
This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
This study compares different adaptation approaches in a P300-based BCI neurofeedback training to improve short-term attention. Participants will spell several words on a computer by focusing on a letter on the screen while their brain activity is recorded (P300 speller). The difficulty of this task will be adapted to train their attention. Their cognitive abilities will be evaluated using a random dot kinematogram, where they are asked to indicate the direction a fraction of moving dots on the computer screen is going in, before and after the training to analyse any improvements. Questionnaires will be used to compare the perceived task load of the different adaptation approaches.