There are about 2307 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.
The goal of this phase 2, before-and-after interventional study is to investigate the effect of colchicine treatment on serum biomarkers of inflammation in patients with a history of stroke and atherosclerosis. Participants meeting inclusion criteria will have blood samples drawn at baseline, will be dispensed colchicine 0.5mg daily for a treatment period of 30 days and have blood samples drawn again at follow-up. All blood samples will be analysed for a panel of inflammatory blood markers and the change in blood inflammatory markers from baseline to end of treatment will be calculated.
Background: Approximately 480 primary, non-pituitary, brain tumours were diagnosed in Ireland each year between 1994 and 2013. Recent developments in treatment have greatly improved survival for younger patients in the 15-54 age range. The Irish National Neurosurgical Centre and the St Luke's Radiation Oncology Centre at Beaumont Hospital and treat approximately 200 patients with brain tumours per year with a combination of surgery, radiotherapy (RT) and chemotherapy with RT being the most commonly used treatment modality. With improved survivorship, the prospect of individuals living for several decades with co-morbidities induced by the tumour itself or surgical and RT treatments, raises new and complex issues for patients and clinicians. The hypothalamus and pituitary gland in the brain are the key regulators of hormone action. They control several hormone systems including reproductive function (FSH, LH) growth (growth hormone), thyroid (TSH) and adrenal function (ACTH) as well as many other homeostatic mechanisms. It has long been recognised that therapeutic cranial RT to the pituitary gland causes hypothalamic-pituitary dysfunction (hypopituitarism). Traditionally, high-risk groups for post-irradiation hypopituitarism were considered to be patients with pituitary tumours, survivors of childhood cancer and patients who received high-dose RT to treat nasopharyngeal cancers. The potential for cranial radiotherapy to cause significant pituitary dysfunction in adult patients with brain tumours has received little attention. The assumption has been that the hypothalamic-pituitary axis is more resistant in adults than in children to the effect of cranial RT. However, it is likely that the higher doses of RT, used to treat primary brain tumours in adults, causes significant hypothalamic-pituitary dysfunction resulting in hypopituitarism. Preliminary data from the National Pituitary Centre in Beaumont Hospital has revealed that adult patients, treated with cranial radiotherapy for primary, non-pituitary brain tumours, are at risk of hypopituitarism. Approximately 40% of patients had pituitary deficiencies in at least one hormone axis, while 25% of patients had deficiencies in multiple hormone axes. Hypopituitarism confers significant morbidity and increased mortality to patients. At present, adult survivors of brain tumours are referred to the pituitary service for assessment on an ad-hoc basis meaning that many patients with hypopituitarism may go undiagnosed. In addition to the challenges caused by hypopituitarism, long-term neuropsychological outcomes following a brain tumour cause significant functional impairments and reduced HR-QOL. Patients can present with impairments in specific cognitive domains such as memory and executive functioning or more global systems such as attention as well as significant issues with fatigue. In addition to these primary deficits, patients can also present with significant distress, fluctuant mood and anxiety. Despite the impact of brain tumours can exert, the National Cancer Control Program's National Survivorship Needs Assessment Review (2019) did not identify any studies reporting the needs of adult survivors of brain tumours in Ireland. There is an urgent need to understand the impact of hypopituitarism and its treatment on HR-QOL and neuropsychological functioning. The proposed study will add to the limited existing literature on the prevalence of hypopituitarism in adult survivors of brain tumours treated with radiotherapy and generate detailed information on deficiency rates for individual pituitary hormones and how these deficiencies emerge over time. This will also be the first study to examine if treatment of radiotherapy-induced hypopituitarism (as part of routine clinical care) is associated with improved HR-QOL and neuropsychological functioning.
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries. The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - EORTC QLQ-C30, to test concurrent validity. - Live-CAT version, to test the feasibility of such implementation. - EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability.
The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.
Patients with chronic pancreatitis suffer from constant debilitating symptoms. They have complex needs and require specialist, multi-disciplinary care. The investigators have developed a mobile phone app for patients with chronic pancreatitis, called the SmartCP app - the first app of its kind for this patient group. What is SmartCP? SmartCP is an app that allows patients to log daily symptoms, diet, and physical activity for review at clinic. It creates a red-alert for action if there are worsening symptoms. A Monthly-Check-In feature looks for symptoms of new diabetes or pancreatic cancer. SmartCP provides education on every aspect of pancreatitis, as well as contact information for the clinical team and for important pancreatitis resources. To develop SmartCP, the investigators established a multidisciplinary steering committee. The study The investigators aim to conduct a feasibility study to determine if the SmartCP app is feasible in the management of patients with chronic pancreatitis, complementing current specialist healthcare. Specifically, they will investigate acceptability, retention, incidents, resources, app user statistics, as well as investigating the occurrence of crisis events, symptoms, escalating symptoms, new diagnoses of diabetes or pancreatic cancer, and the use of communication and education features.
This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.
Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp. The smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised We have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps. The goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.
This study relates to men with hypogonadism, a condition describing a deficiency of androgens such as testosterone. Deficiency of these hormones occurs in men due to testicular (primary) or hypothalamic-pituitary (secondary) problems or may be observed in men undergoing androgen deprivation therapy for prostate cancer. Testosterone plays an important role in male sexual development and health, but also plays a key role in metabolism and energy balance. Men with testosterone deficiency have higher rates of metabolic dysfunction. This results in conditions such as obesity, nonalcoholic fatty liver disease, diabetes, and cardiovascular disease. Studies have confirmed that treating testosterone deficiency with testosterone can reduce the risk of some of these adverse metabolic outcomes, however cardiovascular mortality remains higher than the general population. We know that testosterone deficiency therefore causes metabolic dysfunction. However, research to date has not established the precise mechanisms behind this. In men with hypogonadism there is a loss of skeletal muscle bulk and function. Skeletal muscle is the site of many critical metabolic pathways; therefore it is likely that testosterone deficiency particularly impacts metabolic function at this site. Men with testosterone deficiency also have excess fat tissue, this can result in increased conversion of circulating hormones to a type of hormone which further suppresses production of testosterone. The mechanism of metabolic dysfunction in men with hypogonadism is therefore multifactorial. The purpose of this study is to dissect the complex mechanisms linking obesity, androgens and metabolic function in men. Firstly, we will carry out a series of detailed metabolic studies in men with testosterone deficiency, compared to healthy age- and BMI-matched men. Secondly, we will perform repeat metabolic assessment of hypogonadal men 6 months after replacement of testosterone in order to understand the impact of androgen replacement on metabolism. Lastly, we will perform the same detailed metabolic assessment in men with prostate cancer before and after introduction of a drug which causes testosterone deficiency for therapeutic purposes.
According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major peri-intubation adverse events during anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide. STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.