[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Royal College of Surgeons, Ireland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":664},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,49,78,109,135,160,186,206,227,253,275,305,326,347,365,392,421,450,476,505,534,559,585,617,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100651944","tracheostomy-practice-in-adult-intensive-care-units-100651944",false,"NCT07769021","Tracheostomy Practice in Adult Intensive Care Units","Observational iNternational Study of TRACHeostomy Practice in Adult Intensive Care Units - ON TRACH","ON TRACH","Inclusion Criteria:\n\n* Greater than 18 years of age\n* Tracheostomy insertion during critical care admission\n\nExclusion Criteria:\n\n* Tracheostomy prior to critical care admission\n* Elective tracheostomy insertion for head and neck pathology\n* Tracheostomy insertion for emergency surgical management of airway obstruction\n* Mini tracheostomy insertion only","ALL","18 Years",{"count":21,"type":22},2500,"ESTIMATED","OBSERVATIONAL","ON TRACH is an international, multicentre, observational study with the aim of characterising the timing and practice of tracheostomy insertion, management, weaning and longer-term outcomes of these patients, in intensive care units internationally. Participating intensive care units (ICU) will recruit all consecutive patients undergoing tracheostomy insertion over a 12 week period, aiming for broad global representation. This will allow identification of variation in care of patients with a tracheostomy in the intensive care and it's origin, to drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.",[26,27,28],"Tracheostomy Patients","Tracheostomy Decannulation","Intensive Care (ICU)",[30,31,32,33,34,35],"tracheostomy","decannulation","intensive care","prolonged mechanical ventilation","tracheostomy weaning","tracheostomy outcomes","NOT_YET_RECRUITING","2026-08-12",{"date":39,"type":40},"2026-08-17","ACTUAL",{"date":42,"type":22},"2026-11-02",{"date":44,"type":22},"2029-03",{"name":46,"class":47},"Royal College of Surgeons, Ireland","OTHER",13,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100597386","the-achills-trial-application-of-cerament-in-heel-infection-for-lower-limb-salvage-100597386","NCT07057817","The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage","Randomised Controlled Trial Comparing Partial Calcanectomy Plus Local Application Antibiotic Impregnated Bone Graft Substitute for Calcaneal Osteomyelitis vs Partial Calcanectomy Alone (The ACHILLS Trial)","ACHILLS","Inclusion Criteria:\n\n* 18 and over\n* Undergoing partial calcanectomy\n* Patients with Type1 or Type 2 Diabetes\n* Patients will be stratified by Pulse status and eGFR\n\nExclusion Criteria:\n\n* Patients unfit for surgery\n* Patients unable to provide informed consent\n* Patients with overwhelming sepsis that require major amputation\n* Patients with hypersensitivity to aminoglycosides\n* Pre-existing calcium metabolism disorder\n* Severe renal impairment\n* Patients in whom major limb amputation is deemed inevitable by the treating physician",{"count":5,"type":22},"INTERVENTIONAL",[60],"NA","The ACHILLS Trial is a multicentre randomised controlled feasibility study comparing partial calcanectomy with and without the use of an antibiotic-impregnated bone graft substitute (Cerament G) for treating calcaneal osteomyelitis, specifically on wound healing rates, re-infection, and overall efficacy in a sample of 30 patients over a one-year period.",[63,64,65],"Osteomyelitis","Diabetes","Calcanectomy",[65,67],"Eq5d5l","RECRUITING","2026-07-20",{"date":71,"type":40},"2026-07-22",{"date":73,"type":40},"2026-01-01",{"date":75,"type":22},"2029-12",{"name":46,"class":47},1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100565831","envelop-wound-care-following-pilonidal-sinus-surgery-100565831","NCT06647290","ENVELOP: Wound Care Following Pilonidal Sinus Surgery","Excision and Negative Pressure Wound Therapy Versus Excision and Leaving Open With Standard Wound Care for Management of Chronic Pilonidal Sinus Disease - A Randomised Controlled Trial","ENVELOP","Inclusion Criteria:\n\ni) They are aged 18 years or older\n\nii) They are undergoing elective pilonidal sinus excision without primary closure\n\nExclusion Criteria:\n\ni) They are unable to adhere to protocol requirements e.g. questionnaire completion\n\nii) They are undergoing emergency drainage for a pilonidal abscess\n\niii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft\n\niv) They have underlying osteomyelitis\n\nv) They have underlying fistulating disease e.g. Crohn's",{"count":87,"type":22},200,[60],"This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).",[91,92],"Pilonidal Sinus","Wound Healing",[94,95,96,97,98,99,100,101],"Negative Pressure Wound Therapy","Surgical Site Infection","Post-operative Complications","Health Economics","POSAS","CoPaQ","EQ-5D-5L","Pain Score",{"date":71,"type":40},{"date":104,"type":40},"2024-10-01",{"date":106,"type":22},"2027-06",{"name":46,"class":47},10,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":58,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100518031","pinta---prophylactic-incisional-negative-pressure-therapy-for-major-amputations-100518031","NCT06025253","PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations","Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations","PINTA","Inclusion Criteria:\n\n* Patients aged 18 years or older;\n* Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;\n* Patients with primary closure of the surgical incision using either interrupted or continuous sutures\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years;\n* Women who are pregnant and\u002For breast-feeding;\n* Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;\n* Patients with amputations where skin glue is the only means of skin closure\n* Patients with a clinically absent femoral pulse",{"count":118,"type":22},728,[60],"Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.",[122,123,124],"Wound Surgical","Wound Infection","Cosmesis",[94,95,96,97,99,126],"WoundQol",{"date":128,"type":40},"2026-07-21",{"date":130,"type":40},"2024-03-01",{"date":132,"type":22},"2028-12",{"name":46,"class":47},7,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":58,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100645486","acceptability-of-fitskills-in-the-irish-context-for-young-people-with-childhood-onset-physical-disability-100645486","NCT07703306","Acceptability of FitSkills in the Irish Context for Young People With Childhood-onset Physical Disability","The Feasibility and Acceptability of Translating FitSkills to the Irish Context to Facilitate Physical Activity Participation for Young People With Childhood-onset Physical Disability","Inclusion Criteria:\n\n* Have a primary physical disability diagnosis, either congenital or acquired by age 15\n* Are aged between 13-24 years\n* Have not taken part in a regular gym programme in the previous 3 months (i.e. at least once a week for 3 months)\n* Can follow instructions in English\n* Are fit and well enough to participate in exercise\n\nExclusion Criteria:\n\n* Have an acute or concurrent medical condition rendering them unfit to participate in moderate-level physical activity\n* If they had an impaired ability to take part safely in a gym environment due to significant behavioural challenges.","13 Years","24 Years",{"count":7,"type":22},[60],"FitSkills is an evidence based community based gym programme developed in Australia. It was developed in response to the barriers people with disability experience to accessing community-based physical activity. Within FitSkills, people with disability are paired with university students who act as a peer mentor. Pairs exercise together at a community gym location twice a week for 12 weeks. FitSkills has been shown to improve physical and social health among people with disabilities.\n\nFitSkills has not been delivered outside of Australia. The investigators are assessing how practical it is to deliver FitSkills in Ireland with the support of healthcare and physical activity professionals. The investigators want to understand the demand for this programme among young people with childhood-onset physical disability aged 13-24 years. In addition, the investigators want to learn if taking part in FitSkills influences exercise confidence and mental health and well-being among young people with childhood-onset physical disability.",[148],"Physical Disability",[150,151],"physical activity","physical disability","2026-07-10",{"date":154,"type":40},"2026-07-14",{"date":156,"type":22},"2026-07",{"date":158,"type":22},"2027-01",{"name":46,"class":47},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":167,"minAge":19,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":58,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":77},"100644632","the-effect-of-a-post-operative-exercise-programme-versus-standard-care-on-physical-fitness-of-patients-with-breast-cancer-undergoing-deep-inferior-epigastric-perforator-diep-flap-reconstruction-surgery-100644632","NCT07672392","The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery","EXERCISE DIEP","Inclusion Criteria:\n\n1. Women aged 18 years and older\n2. Candidates who have already been selected to undergo mastectomy and reconstruction by the breast MDT for the following indications:\n\n   1. Genetic mutation carriers undergoing risk-reducing mastectomy.\n   2. Ductal carcinoma in situ (DCIS) requiring mastectomy.\n   3. Early invasive breast cancer requiring mastectomy.\n   4. The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or pectoralis major muscle (as proven on MRI).\n3. Candidates for breast reconstruction with DIEP.\n4. Fluent in English\n5. Fit for general anaesthetic Signed informed consent form\n\nExclusion Criteria:\n\n1. Advanced breast cancer with skin involvement.\n2. Undergoing bilateral DIEP reconstruction or other forms of breast reconstruction (e.g., TRAM, implant-based, LD flap).\n3. Pregnancy\n4. Lactation Patients with insufficient English to sign an informed consent (i.e. interpreter required).","FEMALE",{"count":169,"type":22},78,[60],"All patients undergoing mastectomy for breast cancer should be offered the option of reconstructive surgery. The Deep Inferior Epigastric Perforator Flap or DIEP reconstruction as it is commonly referred to, is becoming the favoured reconstruction by both patients and surgeons as it gives a great cosmetic outcome as well as being a good option for patients who may have to undergo radiotherapy treatment after their surgery.\n\nExercise has been demonstrated in previous research to improve tolerance of treatment (particularly chemotherapy), post operative fatigue and the overall quality of life in patients undergoing cancer treatment. Furthermore, it has shown to improve survival in patients who are being treated for breast cancer. The investigators are undertaking this study to investigate whether a structured exercise programme will improve patients fitness after surgery and ultimately improve their recovery after their reconstructive surgery. To do this, half of the people taking part will be undertaking a structured exercise programme and the other half will not and will be assessing which group recover better after their surgery. Currently, no breast reconstruction patients in Ireland are receiving a formal \"exercise prescription\" after their surgery so will be looking to see if this helps people recover better before it is made standard care for every breast patient in Ireland.",[173,174],"Breast Cancer","Exercise",[176,177,174],"Breast cancer","DIEP Reconstruction","2026-06-23",{"date":180,"type":40},"2026-06-26",{"date":182,"type":40},"2024-08-01",{"date":184,"type":22},"2028-12-30",{"name":46,"class":47},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":167,"minAge":19,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":58,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":205,"locationsCount":77},"100639342","evaluating-the-de-escalation-of-surveillance-for-patients-who-have-undergone-curative-treatment-for-primary-breast-cancer-100639342","NCT07616258","Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer","De-Escalation","Inclusion Criteria:\n\n* Participants will be identified according to the eligibility criteria and will be approached and invited to participate in this study while attending the outpatient department at the breast centre in Beaumont Hospital. To be eligible to participate in this study, an individual must meet all of the following eligibility criteria:\n* Female patients who are under cancer surveillance for a primary breast cancer which was treated with curative intent\n* Aged 18 years or older at the time of 24-month surveillance\n* Demonstrate no clinical or radiological evidence of disease recurrence or metastases at the time of recruitment (e.g.: palpable mass, skin or nipple changes, new indeterminant mass on mammography, etc)\n* Fully fluent in English Language (Reading, Writing, and Speaking - has the ability to complete the EQ5D5L questionnaire in paper form and over the phone)\n* Has a formal address in the Republic of Ireland and has the intention of undergoing further surveillance in this country\n\nExclusion Criteria:\n\nAll individuals meeting any of the exclusion criteria at baseline or during screening will be excluded from study participation as per the following criteria: - An individual who fails to meet any of the aforementioned inclusion criteria will be excluded from participation in this study.",{"count":194,"type":22},560,[60],"Breast cancer is the most common cancer in women around the world. That means a lot of women are affected by it every year, and it's important that we always look for ways to improve their care, not just during treatment, but afterwards too. After treatment for early-stage breast cancer, patients usually come back to the hospital for regular check-ups for up to five years. These visits are based on old guidelines, and even though breast cancer treatment has improved a lot over the years, the follow-up schedule has stayed the same. This study is being done to see if we can safely reduce the number of hospital visits after treatment, while still keeping patients healthy and well looked after.\n\nRight now, patients are asked to attend follow-up appointments at 6, 12, 18, 24, 36, 48 and 60 months (that's every 6 to 12 months for five years). These clinic visits often involve long waits and can cause stress or anxiety. At the same time, patients are also invited for a mammogram once a year. Recent research shows that most recurrences of breast cancer are found by patients themselves or during their annual mammograms, not necessarily at these clinic visits. That's why we're looking at whether we can safely reduce the number of hospital appointments, without affecting patient safety.\n\nIn this study, some patients will continue with the usual five-year clinic schedule. Others will only attend hospital clinics for the first two years (at 6, 12, 18 and 24 months), and after that, they will no longer need to come in for the extra follow-up visits, but they will still have their annual mammograms as normal.\n\nWithin this study all participants will complete a short questionnaire once a year. This will help us understand how the different follow-up plans affect quality of life, and how patients feel about their care. This research study is taking place to find out if fewer hospital check-ups, combined with continued mammogram screening, is just as safe and possibly better for patients' wellbeing.",[173],[173],"2026-05-29",{"date":201,"type":40},"2026-06-01",{"date":203,"type":40},"2025-10-02",{"date":184,"type":22},{"name":46,"class":47},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":58,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":226,"locationsCount":77},"100638875","mct-enteral-feeding-to-reduce-chyle-leak-after-oesophagectomy-100638875","NCT07616245","MCT Enteral Feeding to Reduce Chyle Leak After Oesophagectomy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of oesophageal cancer (adenocarcinoma or squamous cell carcinoma)\n* Planned minimally invasive or robotic-assisted oesophagectomy (MIO or RAMIO) with curative intent\n* Placement of feeding jejunostomy at or prior to oesophagectomy\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* No feeding jejunostomy placed at or prior to surgery\n* Prior or concomitant malignancy that would interfere with study protocol or outcomes",{"count":213,"type":22},160,[60],"Chyle leak (chylothorax) is a recognised complication following minimally invasive oesophagectomy for oesophageal cancer and may result in prolonged hospital stay, nutritional compromise, and need for additional interventions.\n\nMedium-chain triglyceride (MCT) feeds reduce lymphatic flow as they are absorbed directly via the portal circulation rather than through the thoracic duct. While MCT feeds are commonly used in the management of established chyle leaks, their role in prevention has not been evaluated in a randomised controlled trial.\n\nThis single-centre randomised controlled trial will evaluate whether initiating postoperative jejunostomy feeding with MCT-based enteral nutrition reduces the incidence of clinically and biochemically confirmed chyle leak compared with standard enteral feeding in patients undergoing minimally invasive or robotic-assisted oesophagectomy.\n\nParticipants will be randomised in a 1:1 ratio to receive either MCT-based feeds or standard jejunostomy feeds starting on postoperative day 1. The primary outcome is the incidence of chylothorax. Secondary outcomes include chest drain output, re-intervention rates, and length of hospital stay.",[217],"Oesphageal Cancer",[219,220,221],"Robotic Oesophagectomy","Enhanced Recovery After Surgery","Oesphagectomy",{"date":201,"type":40},{"date":203,"type":40},{"date":225,"type":22},"2028-12-31",{"name":46,"class":47},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":58,"phases":235,"briefSummary":236,"conditions":237,"keywords":241,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":77},"100638378","the-development-of-the-walsh-asthma-self-management-programme-and-feasibility-of-implementation-in-adults-with-asthma-in-primary-care-100638378","NCT07609134","The Development of the Walsh Asthma Self-management Programme and Feasibility of Implementation in Adults With Asthma in Primary Care","Inclusion Criteria:\n\n* Adults over 18 years old\n* Adults who meet one of the following criteria:\n\na physician's diagnosis of asthma; coded as asthma (R96) as per the international classification of primary care (ICPC) or international classification of diseases (ICD) code J45 with associated use of asthma medications for 6 months prior to study enrolment.\n\nExclusion Criteria:\n\n* Adults under 18 years old\n* Adults with no diagnosis of asthma\n* Adults receiving asthma education in a specialist hospital or community setting\n* Adults unable to give informed consent\n* Smoking ≥ 10 Pack Year History",{"count":234,"type":22},40,[60],"Asthma is a common medical condition in Ireland. Adult patients tend to have periods when their asthma is stable and periods when it worsens. In order to reduce these periods of worsening asthma, effective ongoing management is required day to day by adults with asthma. Teaching adults how to manage their asthma effectively, plays a huge role in improving their asthma and having a better overall quality of life. This education on managing asthma has many different parts to it. Most adults will discover they have asthma through their general practitioner (GP) and it will be continued to be checked and managed through their GP or general practice nurse (GPN) in their primary care clinic for the duration of their lives.\n\nThis research study is taking place to find out if a new education programme, will help adults manage their asthma better and improve the symptoms of asthma, reducing its overall impact on day-to-day life. This study is also looking at how easy it is to introduce and for nurses to deliver this study within a GP\u002F primary care centre. This study is to find out if this education programme works in a real life setting and if it can lead to better control of asthma for adults.",[238,239,240],"Asthma","Self-management","Asthma Control",[238,242,243,244,245],"self-management education","asthma control","primary care","nursing","2026-05-19",{"date":248,"type":40},"2026-05-27",{"date":250,"type":22},"2026-05",{"date":158,"type":22},{"name":46,"class":47},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":191,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":167,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":77},"100636952","evaluating-the-de-escalation-of-surveillance-for-patients-who-have-undergone-curative-treatment-for-breast-cancer-100636952","NCT07572370","Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Breast Cancer","Evaluating the De-Escalation of Surveillance for Patients Who Have Undergone Curative Treatment for Primary Breast Cancer - A Prospective, Randomised Controlled Trial","Inclusion Criteria:\n\n* Female participants aged 18 years or older\n* Prior diagnosis of primary breast cancer treated with curative intent\n* Currently under cancer surveillance and at the 24-month follow-up timepoint\n* No clinical or radiological evidence of disease recurrence or metastasis at the time of recruitment (e.g., no palpable mass, skin or nipple changes, or suspicious findings on imaging)\n* Able to read, write, and speak English sufficiently to complete the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire (paper-based or via telephone)\n* Resident in the Republic of Ireland with a fixed address and intention to continue follow-up within the Irish healthcare system\n\nExclusion Criteria:\n\n* Evidence of breast cancer recurrence or metastatic disease at the time of recruitment\n* Inability to provide informed consent\n* Inability to complete study questionnaires (e.g., due to language barriers or cognitive impairment)\n* Not resident in the Republic of Ireland or not intending to remain in follow-up within the Irish healthcare system",{"count":194,"type":22},"Patients who were diagnosed with breast cancer and have finished their treatment will be given the opportunity to be part of this study. These patients will have been attending surveillance at the Breast Centre in Beaumont Hospital, Ireland for 2 years prior. These patients, who are doing well after breast cancer treatment, will be given the opportunity to enrol in this study, potentially being discharged from in person surveillance after 2 years, while still attending for their annual mammogram. Investigators intend to find out if a simpler follow-up plan could work just as safely, while also improving the patients quality of life.",[173],[173,264,265,266],"Surveillance","Follow up","Deescalation of breast cancer surveillance","2026-04-30",{"date":269,"type":40},"2026-05-07",{"date":271,"type":40},"2025-12-11",{"date":273,"type":22},"2028-06-01",{"name":46,"class":47},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":283,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":58,"phases":287,"briefSummary":288,"conditions":289,"keywords":294,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":77},"100551020","a-motor-learning-intervention-to-target-walking-performance-in-ambulant-children-with-cerebral-palsy-100551020","NCT06454656","A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy","A \"MOtor Learning Based Intervention for Lower Extremities (MOBILE)\" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study","MOBILE","Inclusion Criteria:\n\n* Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)\n* Has a specific walking related goal\n* Has capacity to follow instruction\n* Has a primary caregiver who can support a home program\n\nExclusion Criteria:\n\n* Has had surgery within 6 months of intervention start date\n* Has had botox\u002F baclofen within 3 months of intervention start date\n* Has a dual diagnosis that impacts ability to follow instruction\n* Has a significant cognitive impairment","6 Years","17 Years",{"count":286,"type":22},14,[60],"The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting.\n\nThe main questions we look to answer are:\n\n1. Do the children\u002Fteens tolerate the therapy and feel that it is helpful?\n2. Do the parents\u002F families feel the therapy helps and is easy to commit to?\n3. Do the children\u002Fteens complete all their therapy sessions and assessments as planned?\n\nThe participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.",[290,291,292,293],"Cerebral Palsy","Walking, Difficulty","Spastic Diplegia","Hemiplegic Cerebral Palsy",[295,296,297],"Motor Learning Theory","Neuroplasticity","Neurological Rehabilitation","2026-04-09",{"date":300,"type":40},"2026-04-14",{"date":302,"type":40},"2024-08-12",{"date":106,"type":22},{"name":46,"class":47},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":312,"sex":167,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":58,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":77},"100625759","margin-optimisation-using-z-axis-assessment-with-real-time-tomosynthesis-mozart-study-100625759","NCT07426809","Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).","MOZART","Inclusion Criteria:\n\n* Female patients\n* Age ≥ 18 years\n* Diagnosis of primary invasive breast cancer or ductal carcinoma in situ (DCIS)\n* Planned breast-conserving surgery with curative intent\n* No clinical or radiological evidence of distant metastatic disease at time of recruitment\n* Able to provide written informed consent\n* Fluent in English (spoken and written)\n\nExclusion Criteria:\n\n* Evidence of metastatic (stage IV) breast cancer\n* Planned mastectomy instead of breast-conserving surgery\n* Prior ipsilateral breast cancer surgery for the current malignancy\n* Inability to provide informed consent\n* Participation in another interventional study that may affect surgical margin assessment",true,{"count":314,"type":22},314,[60],"Breast-conserving surgery is commonly performed to remove early-stage breast cancer or ductal carcinoma in situ (DCIS). During surgery, the goal is to completely remove the tumour with a clear margin of normal tissue around it. If cancer cells are found at the edge of the removed tissue (a \"positive margin\"), patients may need a second operation (re-excision). Re-excision can delay further treatment, increase patient anxiety, and increase healthcare costs.\n\nTo help assess margins during surgery, surgeons use specimen imaging. Standard practice involves two-dimensional (2D) specimen mammography, usually performed in the radiology department. This requires temporary transfer of the specimen out of the operating theatre and provides limited depth information.\n\nThe MOZART study is evaluating whether three-dimensional (3D) digital breast tomosynthesis, performed in the operating theatre using the Mozart system, improves margin assessment compared to standard 2D specimen mammography.\n\nPatients undergoing breast-conserving surgery at Beaumont Hospital who agree to participate will be randomly assigned (like flipping a coin) to one of two groups:\n\nStandard 2D specimen mammography (current standard practice), or\n\n3D digital breast tomosynthesis performed in theatre.\n\nIn both groups, the operating surgeon will review the images during surgery and decide whether additional tissue needs to be removed. The final margin status will be determined by routine laboratory analysis after surgery.\n\nThe main goal of this study is to compare the rate of positive margins between the two imaging methods. Other outcomes include the need for additional surgery, operating time, and overall workflow efficiency.\n\nThe results of this study may help determine whether intraoperative 3D imaging improves surgical outcomes and reduces the need for re-excision in patients undergoing breast-conserving surgery.",[173],[173,310],"2026-03-30",{"date":321,"type":40},"2026-04-03",{"date":323,"type":40},"2025-12-18",{"date":225,"type":22},{"name":46,"class":47},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":58,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":77},"100631671","survey-cns-a-feasibility-study-of-randomising-women-and-men-with-her2-positive-metastatic-breast-cancer-to-central-nervous-system-surveillance-versus-no-surveillance-100631671","NCT07503717","SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance","SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla","SURVEY-CNS","Inclusion Criteria:\n\n* Age ≥18 years\n* Male or female\n* Histologically or cytologically confirmed HER2-positive breast cancer\n* Evidence of metastatic breast cancer\n* Estrogen receptor (ER) positive or negative disease permitted\n* Presence of visceral metastatic disease\n* Receiving active HER2-directed systemic therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Estimated life expectancy greater than 6 months\n* Ability to provide written informed consent\n* Willing and able to comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Prior history of brain metastases\n* History or evidence of leptomeningeal carcinomatosis\n* Symptoms suggestive of brain metastases at screening\n* Bone-only metastatic disease\n* Inability to undergo MRI scanning\n* Known hypersensitivity or contraindication to MRI contrast agents that cannot - be managed per local standard of care\n* Significant medical condition or laboratory abnormality that, in the opinion of - the investigator, makes participation inappropriate Inability to provide informed consent\n* Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances",{"count":335,"type":22},69,[60],"SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging (MRI) surveillance versus standard of care (no routine CNS surveillance).\n\nPatients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Brain metastases can cause significant symptoms, including headache, nausea, seizures, visual disturbance, motor dysfunction, and cognitive or psychological changes. Although new HER2-directed therapies have improved systemic disease control, CNS progression remains common and is associated with reduced quality of life and survival.\n\nCurrently, routine brain imaging is not recommended in asymptomatic patients. Brain imaging is typically performed only when neurological symptoms develop. Observational data suggest that patients diagnosed with asymptomatic brain metastases may have better outcomes than those diagnosed after symptoms occur. However, it is not known whether a surveillance strategy is feasible or acceptable to patients.\n\nAll participants in this study will undergo a baseline contrast-enhanced brain MRI. Patients without evidence of CNS metastases on the baseline scan will be randomised (1:1) to either:\n\nCNS surveillance with repeat brain MRI at 6 and 12 months, or No routine surveillance imaging (standard of care), with imaging only if clinically indicated.\n\nThe primary objective is to determine whether more than 30% of eligible patients approached agree to undergo screening and randomisation. The study will approach up to 193 patients and will be considered feasible if 69 patients consent to screening with intent to randomise.\n\nSecondary objectives include:\n\nDetermining the proportion of patients with previously undetected (occult) CNS metastases at baseline; Determining the incidence of occult CNS metastases during surveillance; Recording symptomatic CNS presentations; Describing management of CNS metastases, including surgery or radiotherapy. Participants will be followed for 14 months from baseline.",[173,339],"HER2-Positive Metastatic Breast Cancer","2026-03-26",{"date":342,"type":40},"2026-03-31",{"date":344,"type":40},"2025-06-01",{"date":273,"type":22},{"name":46,"class":47},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":355,"enrollmentInfo":356,"targetDuration":357,"studyType":23,"phases":4,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":362,"leadSponsor":364,"locationsCount":77},"100631670","a-prospective-study-of-the-genomic-landscape-of-central-nervous-system-disease-secondary-to-breast-cancer-utilising-cell-free-dna-derived-from-cerebrospinal-fluid-csf-100631670","NCT07503704","A Prospective Study of the Genomic Landscape of Central Nervous System Disease Secondary to Breast Cancer Utilising Cell-free DNA Derived From Cerebrospinal Fluid (CSF)","PRIMROSE - A Prospective Study of the Genomic Landscape of Central Nervous System Disease Secondary to Breast Cancer Utilising Cell-free DNA Derived From Cerebrospinal Fluid (CSF)","PRIMROSE","Inclusion Criteria:\n\n1. Male or female.\n2. \\>18 years of age\n3. Any ER, PgR or HER2 status\n4. Newly diagnosed with Breast Cancer Brain Metastasis (BCBM) OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease\n5. Informed Consent\n\nExclusion Criteria:\n\n1. Where the investigator considers it unsafe to undertake a lumbar puncture or perform an aspiration from the Ommaya reservoir.\n2. Unable to comply with study procedures or give informed consent.\n3. Where the investigator considers it not in the best interest of the patient to participate.","99 Years",{"count":335,"type":22},"1 Year","The PRIMROSE CSF Study aims to study cerebrospinal fluid (CSF) in patients with breast cancer that has spread to the brain (brain metastasis) or the lining surrounding the brain (leptomeningeal disease). Research into breast cancer that has spread to the brain or the lining of the brain is limited due to difficulty in obtaining brain tissue containing cancer cells. Such tissue is typically only available when tumours are removed, which does not occur in all patients. Evidence indicates an increasing number of patients with breast cancer are developing disease that spreads to the brain or the lining of the brain as treatments improve. The PRIMROSE CSF Study aims to improve understanding of breast cancers that spread to the brain or brain lining by collecting and analysing the fluid that circulates around the brain and comparing these samples with other cancer and blood samples. Cancer cells that have spread to the brain or its lining shed genetic material into the surrounding fluid. Collection of this fluid enables purification of genetic material released by breast cancer cells. This approach allows examination of the genetic profile of breast cancer cells affecting the brain or its lining without the need for surgery. Differences between the original cancer and metastatic disease in the brain can then be analysed. This research will support improved understanding of why certain breast cancers spread to the brain and contribute to the development of new treatments for breast cancer that has spread to the brain or the lining of the brain.",[173],{"date":342,"type":40},{"date":104,"type":40},{"date":363,"type":22},"2035-10-01",{"name":46,"class":47},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":167,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":58,"phases":374,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":77},"100627049","optimal-mammography-view-sequencing-in-women-with-a-history-of-breast-cancer-undergoing-surveillance-mammography-100627049","NCT07443579","Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography","MammoView","Inclusion Criteria:\n\nFemale patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent\n\nExclusion Criteria:\n\nMale patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment",{"count":373,"type":22},400,[60],"This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups.\n\nThe primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness.\n\nA total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.",[173,377,378],"Breast Cancer Recurrence","Post Treatment Surveillance",[380,381,382,383],"Surveillance Mammography","Mammography View Sequencing","Mammography Technique","Breast Imaging","2026-02-25",{"date":386,"type":40},"2026-03-02",{"date":388,"type":40},"2026-02-24",{"date":390,"type":22},"2030-12-31",{"name":46,"class":47},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":399,"minAge":19,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":58,"phases":402,"briefSummary":403,"conditions":404,"keywords":409,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":77},"100625763","pre-operative-nurse-led-education-with-direct-physiotherapy-referral-to-reduce-post-prostatectomy-incontinence-100625763","NCT07426861","Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence","PRO-ACT","Inclusion Criteria:\n\nMale patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent\n\nExclusion Criteria:\n\nPre-existing urinary incontinence requiring pad use Prior pelvic radiotherapy Prior prostate surgery affecting continence outcomes Medical contraindication to participation in pelvic floor physiotherapy\n\nInability to provide informed consent","MALE",{"count":401,"type":22},80,[60],"Urinary incontinence is a common complication following radical prostatectomy and can significantly impact quality of life. Pelvic floor physiotherapy is recommended to reduce post-operative incontinence; however, referral pathways and patient engagement vary.\n\nThe PRO-ACT trial is a single-centre, parallel-group randomised controlled trial evaluating whether a structured pre-operative education bundle combined with direct physiotherapy referral reduces urinary incontinence following radical prostatectomy compared to standard care.\n\nEligible men undergoing radical prostatectomy at Beaumont Hospital will be randomised 1:1 to either:\n\nStandard of care (educational video and recommendation for physiotherapy with patient-initiated referral), or\n\nA structured pre-operative intervention including a one-to-one ANP-led education session, scheduled post-operative follow-up call, and direct referral to supervised pelvic floor physiotherapy.\n\nThe primary outcome is mean urinary pad usage per 24 hours at 3 months post-operatively. Secondary outcomes include time to continence, quality of life, physiotherapy adherence, and postoperative complication rates.",[405,406,407,408],"Prostate Cancer","Urinary Incontinence","Postoperative Complications","Radical Prostatectomy",[410,411,412,413],"Pelvic Floor Physiotherapy","Preoperative Education","Post-Prostatectomy Incontinence","Continence Recovery","2026-02-16",{"date":416,"type":40},"2026-02-23",{"date":418,"type":40},"2025-12-20",{"date":225,"type":22},{"name":46,"class":47},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":58,"phases":431,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":448,"leadSponsor":449,"locationsCount":77},"100625762","ot-smile-occupational-therapy-group-intervention-for-primary-brain-tumour-patients-100625762","NCT07426848","OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients","Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours","OTSMILE","Inclusion Criteria:\n\nAge ≥ 18 years Diagnosis of primary brain tumour Currently receiving systemic anti-cancer treatment (SACT) Experiencing difficulty with occupational performance (self-reported or clinician-identified) Sufficient cognitive and communication ability to participate in group sessions (assessed clinically and\u002For via screening tool) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Able to provide written informed consent\n\nExclusion Criteria:\n\nECOG performance status ≥ 3 Current inpatient status Major depressive episode or significant psychiatric condition preventing participation in group sessions Significant language barrier preventing participation in English-language sessions\n\nInability to provide informed consent\n\n\\-",{"count":430,"type":22},96,[60],"People diagnosed with primary brain tumours often experience significant symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to carry out everyday activities. These symptoms may be related to the tumour itself or to ongoing systemic anti-cancer treatment. In Ireland, access to structured rehabilitation and symptom management programmes for this population is limited.\n\nThe OT SMILE study is evaluating whether a structured occupational therapy-led group programme can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment.\n\nParticipants attending Beaumont Hospital who meet eligibility criteria and provide informed consent will be randomly assigned (like flipping a coin) to one of two groups:\n\nA six-week occupational therapy group programme (OT SMILE), or\n\nUsual care, consisting of written lifestyle management information.\n\nThe OT SMILE programme consists of six weekly 90-minute group sessions delivered by occupational therapists. Sessions focus on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support.\n\nParticipants in both groups will complete questionnaires before the programme begins and again after six weeks. These questionnaires measure quality of life, fatigue, and daily functioning.\n\nThe main goal of the study is to determine whether the occupational therapy group programme improves health-related quality of life compared to usual care. The results may help inform supportive care services for people living with primary brain tumours.",[434,435,436],"Primary Brain Tumour","Glioblastoma","Brain Neoplasms",[438,439,440,441,442,443,444,445],"Occupational Therapy","Symptom Management","Brain Cancer","Neuro-Oncology","Supportive Care","Rehabilitation","Health Related Quality of Life","FACT-BR",{"date":416,"type":40},{"date":323,"type":40},{"date":225,"type":22},{"name":46,"class":47},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":58,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":77},"100625761","the-pharo-trial-the-incidence-of-para-conduit-hernia-with-closure-of-hiatus-versus-the-standard-approach-in-robotic-oesophagectomy---a-randomised-controlled-pilot-trial-100625761","NCT07426835","The PHARO Trial: The Incidence of Para-conduit Hernia With Closure of Hiatus Versus the Standard Approach in Robotic Oesophagectomy - A Randomised Controlled Pilot Trial","PHARO","Inclusion Criteria:\n\nAge ≥ 18 years\n\nDiagnosis of oesophageal cancer\n\nPlanned robotic oesophagectomy with curative intent\n\nNo clinical or radiological evidence of distant metastases at time of recruitment\n\nAble to provide written informed consent\n\nExclusion Criteria:\n\nEvidence of distant metastatic disease\n\nNot suitable for robotic oesophagectomy\n\nInability to provide informed consent",{"count":234,"type":22},[60],"Para-conduit hernia is a recognised complication following minimally invasive and robotic oesophagectomy. It may present as an incidental radiological finding or as a symptomatic hernia requiring urgent surgical intervention. There is currently no standardised approach to hiatal management during robotic oesophagectomy.\n\nThe PHARO trial is a single-centre, randomised controlled pilot study evaluating whether routine hiatal closure with omentopexy and thoracic fixation of the left crus reduces the incidence of para-conduit hernia compared to the standard approach of no closure or partial closure.\n\nEligible patients undergoing robotic oesophagectomy for non-metastatic oesophageal cancer at Beaumont Hospital will be randomised in a 1:1 ratio to:\n\nStandard hiatal management (no closure or partial closure), or Hiatal closure with omentopexy and thoracic fixation of the left crus.\n\nParticipants will undergo routine postoperative clinical and radiological surveillance. The primary outcome is the incidence of para-conduit hernia within one year following surgery. Secondary outcomes include dysphagia scores, patient-reported outcomes, and 30-day postoperative morbidity.\n\nThis pilot study will enrol 40 participants (20 per group) to inform feasibility and future multi-centre expansion.",[217,461],"Para-conduit Hernia",[219,463,464,465,461,466,467,468,469],"Robot-Assisted Surgery","Hiatal Closure","Omentopexy","Minimally Invasive Oesophagectomy","Upper Gastrointestinal Surgery","Dysphagia","Edinburgh Dysphagia Score",{"date":416,"type":40},{"date":472,"type":40},"2025-12-19",{"date":474,"type":22},"2029-12-31",{"name":46,"class":47},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":58,"phases":485,"briefSummary":486,"conditions":487,"keywords":492,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":77},"100616271","randomised-trial-of-dual-device-treatment-involving-drug-coated-balloon-angioplasty-and-drug-eluting-stent-implantation-compared-to-single-device-treatments-in-patients-with-diabetes-mellitus-100616271","NCT07303439","Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus","DUBSTENT-DM","Inclusion Criteria:\n\n1. Patients with acute or chronic coronary syndrome\n2. Diagnosis of diabetes\n3. Patients undergoing PCI for de novo lesions in native coronary arteries\n4. Patients able and willing to provide written informed consent\n5. Age ≥ 18 years.\n6. Patients able and willing to comply with the study procedures and follow-up.\n7. All angiographic inclusion criteria fulfilled:\n\n   1. the lesion has been deemed treatable\n   2. the guidewire has crossed the lesion\n   3. the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \\>2, and there is no evidence of flow-limiting dissection is seen.\n\nExclusion Criteria:\n\n1. Lesions located at the left main coronary artery.\n2. Patient presents with a ST-elevation myocardial infarction (STEMI).\n3. Patient with acute cardiac decompensation or acute cardiogenic shock.\n4. Patient with impaired renal function (glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2).\n5. Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.\n6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline\n7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.\n8. Patients unable to take dual antiplatelet therapy for 6-12 months\n9. Pregnant and\u002For breast-feeding females or females who intend to become pregnant during the time of the study.\n10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.\n11. Anticipated difficulties to complete the angiographic surveillance.\n12. Patient with a life expectancy of less than 12 months.\n13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.\n14. The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited",{"count":484,"type":22},120,[60],"Purpose of this study:\n\nThe purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.\n\nThe treatment being investigated:\n\nIn this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually:\n\n* Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug.\n* Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again.\n\nBoth drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coronary artery disease in Europe.\n\nHow will the study be carried out?\n\nThis study is being conducted in 4 hospitals across Ireland. We aim to recruit 120 participants s in this study. If you agree to participate in this study and sign the informed consent form, you will be asked to participate in the screening process, which will determine if you meet the conditions to participate in the study.\n\nYou will be \"randomised\" into one of the 3 study groups. Randomisation means that you are put into a group by chance (similarly to the roll of a dice). Neither you nor your doctor can choose the group you will be in. You will not know which group you were placed in until the end of the study. However, your doctor will know which study group you were placed in.\n\n* 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only\n* 40 patients will be treated with Orsiro® (Drug Eluting Stent) only\n* 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent).\n\nIf you agree to participate in the study you will be invited to come back for a check-up angiogram 6 months after your procedure to make sure that the treatment has been a success. This is sometimes done in normal clinical practice, but it is not done routinely. You will not be charged for this additional test.",[488,489,490,491],"Diabetes Mellitus","Coronary Arterial Disease (CAD)","de Novo Coronary Lesions","De Novo Stenosis",[488,493,494,495,496],"Coronary Artery Disease","Drug-coated Balloon","Drug-Eluting Stent","Target Vessel Failure","2025-12-10",{"date":499,"type":40},"2025-12-24",{"date":501,"type":40},"2025-08-06",{"date":503,"type":22},"2031-08-05",{"name":46,"class":47},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":58,"phases":514,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":77},"100570979","phase-1-laparoscopic-assisted-transversus-abdominus-plane-block-versus-intraperitoneal-irrigation-of-local-anesthetic-for-patients-undergoing-laparoscopic-cholecystectomy-100570979","NCT06714279","Laparoscopic-Assisted Transversus Abdominus Plane Block Versus Intraperitoneal Irrigation of Local Anesthetic for Patients Undergoing Laparoscopic Cholecystectomy","Laparoscopic-Assisted Transversus Abdominus Plane Block Versus Intraperitoneal Irrigation of Local Anesthetic for Patients Undergoing Laparoscopic Cholecystectomy - A Prospective, Randomised Clinical Trial","Inclusion Criteria:\n\n* Adult patients aged 18 years or older will be considered for recruitment into this study if they are indicated to undergo elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Patients failing to meet the above inclusion criteria.",{"count":513,"type":22},144,[515],"PHASE1","This study is being performed to investigate whether the administration of local anaesthetic into the muscles in the abdomen or onto squirting the local anaesthetic onto the liver following keyhole gallbladder surgery is more beneficial in reducing pain post-operatively.\n\nKeyhole gallbladder surgery is typically performed under general anaesthesia (or while the patient is 'fully asleep'), however doctors use other pain relief types to reduce pain after the operation. One of these options is local anaesthetic, which involves the injection of an medication into or onto the part of the body which has been operated on. The reason for doing this is to reduce the pain felt by the patient in the part if the body where the operation occurred. The best way of using these medications remain unclear.\n\nThe local anaesthetic being used in the study is fully approved for use in Ireland and the drug itself is not being tested. In other words, the drug is not an experimental drug. Local anaesthetic drugs are given in different ways in patients who have just had the keyhole surgery on their gall bladder (this is the surgery that you are about to have).\n\nTherefore, the aim of this study is to compare two ways of giving patients these local anaesthetic medications following key-hole gallbladder surgery. These include (1) injecting the medication into the skin at the surgical wounds and squirting it onto the liver (where the gallbladder has been removed from), or (2) injecting the medication into the skin at the surgical wounds and into the muscles in the abdomen (known formally as a transversus abdominus plane block).",[518,519,520],"Laparoscopic Cholecystectomy","TAP Block","Local Anesthetic",[522,523,524,525],"Laparoscopic cholecystectomy","TAP block","Transversus abdominus plane block","Local anesthetic","2025-08-09",{"date":528,"type":40},"2025-08-14",{"date":530,"type":40},"2025-03-12",{"date":532,"type":22},"2026-06",{"name":46,"class":47},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":312,"sex":18,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":58,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":77},"100600556","the-lung-health-check-pilot-100600556","NCT07099027","The Lung Health Check Pilot","Inclusion Criteria:\n\n1. 55 - 74 years of age\n2. Current or former smokers\n\n   * Current: \\>100 cigarettes in lifetime and\u002For currently tobacco smoking\n   * Former: \\>100 cigarettes in lifetime and\u002For no tobacco smoking \\>= 28 days\n3. Referred from a GP for the LHC pilot\n4. PLCOM2012 ≥ 1.51% or LLPv2 ≥2.5% (Lung Cancer Risk Scores)\n\n   * Prostate Lung Cancer Colorectal Ovarian (PLCO) \\& Liverpool Lung Project Version 2 (LLPv2)\n\nExclusion Criteria:\n\n1. Participant-reported history of chest CT in the last 12 months\n2. Inability to undergo non-contrast CT (e.g. \\>200 kg body weight, inability to lie flat)\n3. Participant reported known diagnosis of other advanced stage cancers\n4. Participant reported diagnosis of lung cancer of any stage in the last 5 years\n5. Likely non-compliance with study procedures, as determined by the participant i) Unable to provide informed consent ii) Inability to attend study visits\n6. Nursing home residents -","55 Years","74 Years",{"count":543,"type":22},2183,[60],"This study aims to test if it is feasible to introduce lung cancer screening in Ireland.\n\nPeople within a certain age group, who smoke or who smoked in the past, are at a greater risk of developing lung cancer. They can also develop chronic lung conditions that can affect their long-term health. In Ireland, about 2,690 people are diagnosed with Lung Cancer every year. Unfortunately, 2 out of every 3 people diagnosed with lung cancer die per year.\n\nThe goal of this study is to try to screen for lung cancer in people before they have symptoms associated with the disease. We aim to do this by selecting people based on their age, whether they have smoked in the past or currently smoke as well as other relevant factors. People who take part in this study will have an assessment of how their lungs work and a low-dose CT scan. This is called a lung health check. The goal of the low-dose CT scan is to pick up lung cancer before it becomes symptomatic, and at an earlier stage. This scan uses a very low dose of radiation.\n\nUnfortunately, without early detection, such as is the goal of this trial, 8 out of 10 people who go on to develop lung cancer will have advanced lung cancer when it is discovered, where outcomes tend to be poor. The earlier detection of lung cancer has a greater potential for treatment. Current international recommendations suggest carrying out these scans in the community rather than in a hospital. Therefore, we aim to deliver these lung health checks using a mobile unit in the community.\n\nThis study aims to test if we will successfully pick up lung cancer earlier by doing community-based 'lung health check's using mobile units in North Dublin and the North East, among people of a certain age and smoking history.",[547],"Non-Small Cell Lung Cancer",[549,550],"Screening","Lung cancer","2025-07-24",{"date":553,"type":40},"2025-08-01",{"date":555,"type":40},"2025-05-19",{"date":557,"type":22},"2028-01-15",{"name":46,"class":47},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":582,"leadSponsor":584,"locationsCount":4},"100597591","gastrin-anti-helicobacter-pylori-and-pepsinogen-diagnostic-accuracy-study-100597591","NCT07060482","Gastrin, Anti-helicobacter Pylori and Pepsinogen Diagnostic Accuracy Study","Diagnostic Performance of Combined Assays for Gastrin-17, Pepsinogen and Anti-helicobacter Pylori Antibodies for Diagnosing Gastric Atrophy.","GAP-DA","Inclusion Criteria:\n\n* Patients presenting for a routine diagnostic gastroscopy.\n\nExclusion Criteria:\n\n* Patients presenting for a therapeutic procedure such as dilations or stenting.",{"count":568,"type":22},240,"This research study is taking place to find out if a simple blood test can diagnose inflammation in the stomach. Prolonged inflammation in the stomach can lead to Ulcers and even Cancer in the long run.\n\nCurrently, a camera test is needed to identify inflammation in the stomach. The method being tested in this study may be able to do this using just a pinprick of blood.\n\nIf this test proves to be good at diagnosing inflammation in the stomach with just a pinprick of blood, it may be used in the future to decide who actually needs to have a full camera test done or not. This could really improve the waiting lists for these camera tests in the future. It may also mean that we can identify problems at an earlier stage.",[571],"Gastric Atrophy",[573,574,575,576,577],"gastric atrophy","pepsinogen","gastrin 17","anti-helicobacter pylori antibodies","gastroscopy","2025-07-01",{"date":580,"type":40},"2025-07-11",{"date":553,"type":22},{"date":583,"type":22},"2026-02-01",{"name":46,"class":47},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":592,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":58,"phases":595,"briefSummary":596,"conditions":597,"keywords":604,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":77},"100595037","frailty-intervention-in-postoperative-hip-fracture-inpatients-100595037","NCT07027241","Frailty Intervention in Postoperative Hip Fracture Inpatients","Multicomponent Exercise and Nutrition Based Frailty Intervention in Postoperative Hip Fracture Inpatients","Inclusion Criteria:\n\n* Older adults \\>\u002F= 65\n* Clinical Frailty Score 4-6 (This includes patients with very mild, mild and moderate frailty. This would be in keeping with literature quoting frailty interventions where patients who are 'pre-frail' and frail are included)\n* Post fragility hip fracture (including subtrochanteric fracture)\n* Post hip fracture surgery (all types including total hip replacement, hemiarthroplasty, IM nailing)\n* Medically stable postoperatively\n* No weightbearing restriction\n* Mobile pre-admission (including aids and max assist of 1 person)\n\nExclusion Criteria:\n\n* Medically unstable (NEWS \\>3, unless a higher cutoff is stipulated by the primary medical researcher)\n* Non fragility hip fracture (fracture from non osteoporotic aetiology, pathologic fracture)\n* Hip surgery for other aetiology (prosthetic joint infection, arthritis, implant loosening, avascular necrosis, periprosthetic fracture)\n* Polytrauma\n* Delirium or severe cognitive impairment (as defined by inability to follow instructions and unable to provide informed consent)\n* Pre-existing neurologic or cardiovascular disorders that would affect participation\u002F compliance with exercise intervention\n* Open hip fracture\n* Other lower limb orthopaedic disorders that affect participation\u002F compliance with exercise intervention\n* Terminal illness with \\\u003C\u002F= 6 months to live\n* Active treatment for cancer (systemic chemotherapy or radiotherapy, patients on oral chemotherapeutic agents\u002F checkpoint inhibitors will be eligible for inclusion)\n* Nursing Home Resident\n* Severe lower limb pain post-op\n* Severe skin issues\u002F ulcers in non-operated lower limb that would preclude utilisation of ankle weights\n* Swallowing disorders\u002F difficulty\n* Renal impairment with eGFR \\\u003C30\n* Hepatic failure\n* Patients with a dairy\u002F soy allergy","65 Years",{"count":594,"type":22},50,[60],"Hip fracture is a big health concern in older adults, and can lead to increased risk of death, reduced level of independence \\& mobility, reduced quality of life, and higher likelihood of admission to nursing homes. Frailty is a medical condition associated with ageing that results in a reduced ability to do daily tasks. A frail older adult is also less able to recover well from conditions that may affect their wellbeing (for example, infections, falls resulting in injuries or hospital admissions). Frailty is common in older adults with hip fractures.\n\nThere has been increasing research showing that frailty can be slowed down and improved by a combination of nutritional supplementation and exercise. However, most of the research in this area has been in frail older adults living at home or in nursing homes. The exercise or nutritional programs in these studies tend to be carried out over weeks or months. There are very few studies looking at older adults in hospital and how exercise and nutrition help with frailty over shorter periods of time, even more so in patients who have sustained an injury.\n\nThere is, however, very little research in hospital based frailty programs in older patients who have suffered major trauma. It is well known that standing up and starting to walk soon after a hip fracture improves time to recovery, reduces hospital length of stay and death. Hence, physiotherapy on the first day after hip fracture surgery is now recommended. However, there needs to be more research to aid in developing physiotherapy and exercise programs that are safe and doable in the care of hip fracture patients despite limited resources in our healthcare system.\n\nSimilarly, although malnutrition is common in frail older adults with hip fractures, the benefits of nutritional supplementation in these patients is not fully understood. It is known that having a hip fracture puts a person at risk of muscle breakdown and increasing protein intake is recommended to help reduce this risk. Research on exercise and nutrition based frailty programs specific to hip fracture patients is strongly needed, specifically the development of that are doable and safe in the hospital setting that can help improve outcomes in hip fracture patients after surgery.\n\nThe investigators believe that a multicomponent exercise and nutrition based frailty program will be safe, doable and acceptable in frail older adults after hip fracture surgery.",[598,599,600,601,602,603],"Hip Fractures (ICD-10 72.01-72.2)","Frailty at Older Adults","Strength Training","Resistance Training","Exercise Training","Protein Supplementation",[605,174,606,607,608,609],"Hip fracture","Nutrition","Protein supplementation","Strength and resistance training","Frailty","2025-06-16",{"date":612,"type":40},"2025-06-18",{"date":553,"type":22},{"date":615,"type":22},"2026-02",{"name":46,"class":47},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":58,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":4},"100590268","use-of-different-enteral-feeds-to-impact-on-chyle-leaks-in-oesophagectomy-100590268","NCT06965205","Use of Different Enteral Feeds to Impact on Chyle Leaks in Oesophagectomy","Impact of Enteral Feeding Approaches on Chyle Leaks in Oesophageal Cancer Surgery","Inclusion Criteria:\n\n* All adults aged over 18 years undergoing MIO or RAMIO for oesophageal cancer (adenocarcinoma and squamous cell cancer) at Beaumont Hospital will be approached for inclusion.\n\nExclusion Criteria:\n\n* Patients will be excluded if\n\n  * They are unable to provide informed consent\n  * They do not receive a feeding jejunostomy at or prior to their oesophagectomy\n  * Prior or concomitant malignancy that would interfere with this protocol",{"count":213,"type":22},[60],"Oesophagectomy (surgery to remove a cancerous portion of the oesophagus or gullet) is the cornerstone of treating oesophageal cancer. In recent years, minimally invasive techniques, including robotic assisted oesophagectomy have been introduced. These techniques reduce stress on patients, reduce pain, reduce the length of stay in hospital after their operation, without compromising cancer outcomes (and in some cases improving cancer outcomes). Any surgery carries the risk of complications. One complication that may arise with oesophagectomy is an increase in chyle leaks. Chyle is a fluid produced by the body that helps transport nutrients from the bowel to the bloodstream to allow them to be absorbed and processed. One of the channels that transports chyle, the thoracic duct, is divided as part of an oesophagectomy. Although it is clipped to reduce the risk of chyle leak, this may still occur, in up to 25% of operations. If a chyle leak occurs, a drainage tube needs to remain in the chest for a number of days, there may be alterations in the use of feeding techniques, and in a small portion of cases, there may need to be an operation to stop a leak, or a procedure in the radiology department. The goal of this study is to see whether use of a different type of post-operative feed (medium chain triglyceride or MCT feeds) can reduce the rate of chyle leak. This is already used\n\nto treat chyle leaks, and the question is whether using this as the routine post-operative feed can reduce rates of chyle leakage.",[628],"Oesophageal Cancer",[630,631,632],"Oesophageal cancer","chyle leak","MCT feed","2025-05-01",{"date":635,"type":40},"2025-05-11",{"date":637,"type":22},"2025-05-05",{"date":390,"type":22},{"name":46,"class":47},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":58,"phases":648,"briefSummary":649,"conditions":650,"keywords":652,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":4},"100580841","maintain-activity-in-arthritis-a-feasibility-study-100580841","NCT06842550","MAintAin Activity in Arthritis: A Feasibility Study","MAintAin","Inclusion Criteria: Those who have exited from a supervised group-based exercise programme for arthritis.\n\n\\-\n\nExclusion Criteria: Those aged under 18 years\n\n\\-",{"count":5,"type":22},[60],"Best practice guidelines across the world always recommend those living with arthritis to be physically active. Research shows that being active can help people living with arthritis to do the things that they want to do for longer, reduce pain, improve quality of life and protect against getting other health conditions such as heart disease, lung disease and cancer. Whilst various exercise programmes support people with arthritis to be active most individuals reduce their level of PA after completion of a prescribed programme. Staying active in the longer-term is more difficult and there is often a decrease in activity over time. Research has shown that exercise programmes helping people to become active, such as exercise classes, may not always have the right approach and focus during the programme to help people to stay active long-term. It is important to understand if people with arthritis can be supported to maintain their activity levels well in to the future. The investigators have already spoken to people living with arthritis, people involved in arthritis care and those involved in promoting physical activity. The research team brought their feedback and the scientific literature together and shaped a new intervention that suits the needs of people with arthritis and helps them to continue to be physically active. The investiagtors will now ask people living with arthritis to try out the new intervention.\n\nParticipants will receive up to five coaching sessions that aim to support people with arthritis to maintain their PA after exiting a structured exercise programme. Sessions will be delivered within community venues in a group setting by a trained provider. Sessions will last approximately between 60 and 90 minutes and will be delivered over a period of approximately 4-months.\n\nParticipants may receive a smartwatch with an inbuilt step counter such as Fitbit and diary to record their daily steps or physical activity minutes. The diary will also be used to record physical activity maintenance goals, complete action plans and self-monitor progress to build new habits. Participants can continue to use their own smartwatch if they have one.\n\nThe research team are interested to know if the programme has any effect on the amount of activity people do over time as well as looking at factors which can help with the understanding of 'why' or 'why not' a PA intervention may have worked.",[651],"Arthritis",[651,653,654,655],"Physical Activity Maintenance","Feasibility","Health coaching","2025-02-18",{"date":658,"type":40},"2025-02-24",{"date":660,"type":22},"2025-03-01",{"date":662,"type":22},"2025-12",{"name":46,"class":47},""]