[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Swansea Bay University Health Board\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,79,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638024","l-prf-in-prevention-of-orn-and-mronj-following-tooth-extractionsv30-100638024",false,"NCT07585123","L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0","Role of Platelet-Rich Fibrin in the Prevention of Osteoradionecrosis and Medication-related Osteonecrosis of the Jaw Following Tooth Extractions: A Prospective, Triple-Blind, Randomised Feasibility Trial","Inclusion Criteria:\n\n-General Inclusion Criteria (Applies to All Participants)\n\nAge ≥18 years\n\nRequiring extraction of one or more teeth with hopeless prognosis\n\nCapacity to provide informed consent\n\nAbility and willingness to attend all scheduled follow-up visits over 12 months\n\n-Post-Radiotherapy Group - Specific Inclusion\n\nPrevious radiotherapy to the head and neck region\n\nDocumented radiation dose ≥50 Gy\n\nRadiotherapy records (dose, field, date) must be available\n\n-Antiresorptive Group - Specific Inclusion\n\nCurrent or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)\n\nMedication history must be available in medical records\n\nExclusion Criteria:\n\n* General Exclusion Criteria (Applies to All Participants)\n\nInability to maintain adequate oral hygiene due to motor disability\n\nUncontrolled systemic illness (e.g. uncontrolled diabetes)\n\nUse of anticoagulants, immunosuppressants, or medications known to impair healing\n\nRequirement for surgical (complex) extractions\n\nEnrolment in another clinical trial\n\nKnown allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol\n\nAnticipated non-compliance with follow-up\n\n-Post-Radiotherapy Group - Specific Exclusion\n\nPrevious or current antiresorptive therapy\n\nHistory of re-irradiation or radiation dose \\\u003C50 Gy\n\n-Antiresorptive Group - Specific Exclusion\n\nHistory of head and neck radiotherapy\n\nNeoplastic involvement of the jaws\n\nActive untreated oral infection or pathology at time of planned extraction",true,"ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. These conditions are associated with significant morbidity, including persistent pain, poor oral function, and reduced quality of life.\n\nWhile preventive strategies remain limited, platelet-rich fibrin (L-PRF), an autologous fibrin matrix enriched with growth factors, has shown potential in promoting wound healing and modulating inflammation. This prospective, triple-blind, randomised pilot trial aims to evaluate the effectiveness of L-PRF in enhancing socket healing and reducing the incidence of ORN and MRONJ. Forty patients (20 post-radiotherapy, 20 on antiresorptive agents) undergoing non-surgical dental extractions will be randomised to receive either L-PRF or standard care. The primary outcome is mucosal healing at Day 10 post-extraction, assessed using the Landry wound healing index. Secondary outcomes include the incidence of ORN or MRONJ at extraction sites assessed at 9, 17, 25, and 52 weeks. This study aims to provide early evidence on the clinical utility of L-PRF in preventing osteonecrosis in high-risk patients.",[27,28],"Osteoradionecrosis of the Jaw","Medicine Related Osteonecrosis of the Jaw",[30],"L-PRF, ORN, MRONJ","NOT_YET_RECRUITING","2026-05-06",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":21},"2026-08-02",{"date":39,"type":21},"2028-07-31",{"name":41,"class":42},"Swansea Bay University Health Board","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":68,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":43},"100621015","mrinrt-swansea-university-and-swwcc-collaboration-study-100621015","NCT07365124","MRinRT: Swansea University and SWWCC Collaboration Study.","Developing and Optimising the Use of Magnetic Resonance Imaging and Spectroscopy in Radiotherapy (MRinRT) Pathways: Investigating Avenues to Improve Outcomes for Patients and the Assessment of Treatment Response.","MRinRT","Inclusion Criteria for health volunteers:\n\n* Free from medical conditions that could confound imaging or study results\n* Eligible for MRI\n\nInclusion Criteria for patients:\n\n* Confirmed diagnosis of invasive carcinoma at the relevant tumour\u002Ftarget sites listed in this protocol\n* Scheduled to receive radiotherapy to the target site\n* ECOG performance status of 0-2\n* Eligible for MRI (determined through MRI safety screening)\n\nExclusion Criteria:\n\n* Presence of medical conditions that may interfere with study outcomes or data interpretation\n* Use of regular medications that could affect imaging results or safety\n* Any contraindications to MRI scanning, including but not limited to claustrophobia, reduced thermal regulatory capabilities, MR Unsafe implants and foreign bodies.",{"count":53,"type":21},165,"OBSERVATIONAL","The aim of this study is to learn whether using MRI (magnetic resonance imaging) scans to plan radiotherapy is better than using CT (computed tomography) scans alone. The main questions it aims to answer is:\n\n* Can MRI scan images be adjusted to make the tumour and normal tissues easier to see?\n* Does adding MRI to a radiotherapy planning CT make the radiotherapy plan more precise?\n* Can MRI be used to adjust a radiotherapy plan during a course of treatment to make it more precise, and might that reduce the side effects?\n* Are there particular MRI scans that can predict how a tumour will respond to radiotherapy or how likely the patient is to have side effects?\n\nThis study will assess current MRI scanning procedures and ensure these are adjusted to best suit radiotherapy planning. It will also provide pilot data evaluating:\n\n1. MRI-adapted radiotherapy Usually, radiotherapy plans are based on a pre-treatment planning CT scan. Unless an issue is detected the patient would complete their whole course of radiotherapy on this plan. This does not account for changes in position\u002Fsize\u002Fshape of the tumour that occur over the whole treatment course. Clinicians therefore increase the size of the tumour\u002Ftarget to account for these uncertainties, which can increase side effects. This study will assess the potential to reduce side effects from radiotherapy by using repeat MRI scans and replanning during the treatment course (MRI-adaptive radiotherapy).\n2. Imaging biomarkers MRI sequences can be used to predict response to radiotherapy or chance of developing side effects. This study will identify potential MRI sequences that may be used as imaging biomarkers, to guide the development of future clinical trials.\n\nThe study will be undertaken at SBUHB, lasting 4 years, and involving ≤15 healthy volunteers and ≤150 patients.",[57,58,59,60,61,62,63,64,65,66,67],"Carcinoma","Glioblastoma","Radiotherapy","MRI","MRI-guided Adaptive Radiotherapy","MRI Scanner Configuration","MRI Image Enhancement","Oesophageal Carcinoma","Pancreas Carcinoma","Gastric Cancer","Brain (Nervous System) Cancers",[60,59,69,70],"MRI adaptive radiotherapy","MRI Imaging Biomarker","2026-04-29",{"date":73,"type":35},"2026-04-30",{"date":75,"type":21},"2026-05",{"date":77,"type":21},"2032-01",{"name":41,"class":42},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":43},"100631299","detecting-the-undetected-heart-failure-screening-at-the-lymphoedema-point-of-care-100631299","NCT07498868","Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care","Detecting the Undetected: an Observational Cohort Study Evaluating the Health Economics, Clinical Utility, and Patient and Staff Experiences of Innovative Peptide Testing to Screen for Heart Failure in Lymphoedema Clinics","Inclusion Criteria:\n\n* Patient of Swansea Bay University Health Board Lymphoedema Service.\n* Consent to participate in the study.\n* Bilateral lower limb oedema.\n* Aged 18-years or older.\n* Able to provided informed consent to be involved.\n* No diagnosis of heart failure.\n* No NT-proBNP test in the previous 12-months OR increase in lymphoedema severity since an NT-proBNP test in the last 12-months.\n\nExclusion Criteria:\n\n* All inclusion criteria not met.\n* Not a lymphoedema patient in Swansea Bay University Health Board Lymphoedema Service.\n* Unable to consent for themselves.\n* Women who are pregnant or have given birth in the last 6-months.\n* Patients with an existing heart failure diagnosis.",{"count":87,"type":21},618,"Heart failure affects more people than the four most common cancers combined. When identified early, management is more straightforward, preventing complications, hospitalisations, and fatalities. Breathlessness and fatigue are cardinal symptoms of heart failure that can present in a number of conditions. As a result, leg swelling, the third cardinal symptom, is the first noted in many people. The presence of leg swelling leads to patients being seen in lymphoedema clinics before the need for cardiology investigation has been identified. Lymphoedema is the presence of chronic oedema as a result of congenital abnormalities, inflammation, infection, trauma, or cancer and its treatments. The vast majority of lymphoedema patients have swelling in their legs.\n\nA recent study has shown that 9.4% lymphoedema patients need to be investigated for heart failure. At present, the need for investigation is identified by performing a laboratory blood test, which takes time to arrange and complete. An alternate point of care test can provide a result in 12-minutes at the lymphoedema appointment, and enable appropriate action to be taken. This can reduce the demands on primary care and shorten the chain of events to a specialist assessment, as well as reducing inappropriate referrals.\n\nThis research, funded by NHS Wales Performance and Improvement, will perform a point of care test to screen for possible heart failure in lymphoedema clinics and establish the clinical utility by exploring the experiences of patients and staff involved and determining the health economic benefits. A supplementary aim is to compare the point of care test to the currently used laboratory test in a subsample to promote confidence in the test and support efforts to spread and scale across all health boards in Wales on completion.",[90,91,92,93,94],"Lymphedema, Lower Limb","Lymphedema","Heart Failure","Heart Failure (for Example, Fluid Overload)","Heart Failure (HF)",[96,97,98,99,100,101,102,103,104],"lymphoedema","heart failure","undetected heart failure","undiagnosed heart failure","bilateral lower limb oedema","bilateral leg oedema","point of care testing","screening","NT-proBNP","2026-03-23",{"date":107,"type":35},"2026-03-27",{"date":75,"type":21},{"date":110,"type":21},"2028-09",{"name":41,"class":42},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":132,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":43},"100621011","the-primrose-trial-100621011","NCT07365072","The PRIMROSE Trial","A Randomised Controlled Trial to Evaluate the Impact of Thoracic PRehabilitation With Inspiratory Muscle tRaining cOmpared to Standard prEhabilitation in People With Lung Cancer for Surgical Treatment . The PRIMROSE Trial","PRIMROSE","Inclusion Criteria: Adults with lung cancer with surgically resectable disease who are referred for pre-treatment optimization with Prehab, from the lung cancer Multi-Disciplinary Teams (MDTs).\n\nThe referral criteria for Prehab is below:\n\n* ≥1 Medical Research Council (MRC) dyspnoea score\n* ≥1 World Health Organization (WHO) performance status (PS)\n* Age ≥ 70 years\n* Frailty index \\>3\n* Borderline or poor pulmonary function (forced expiratory volume in one second (FEV1) \\\u003C 50% or diffusion capacity for carbon monoxide (DLCO) \\\u003C50%)\n* Sedentary people despite having adequate FEV1 or DLCO\n* People who are eligible for surgical procedures, including endobronchial excision of tumour, or lobectomy, segmental resection, pneumonectomy or wedge resection, either via a minimally invasive approach or a standard thoracotomy approach\n\nAdditionally:\n\n* Participants will be included in the trial if they are capable of providing verbal and written consent for Prehab, and written consent for undergoing a surgical procedure for lung cancer\n* People over 18 years of age\n* All people will be considered regardless of their baseline respiratory muscle strength\n\nExclusion Criteria: Inclusion criteria not met\n\n* People diagnosed with other cancers namely, metastatic lung cancer, mesothelioma, sarcoma, mediastinal tumours, or benign diseases\n* People who decline Prehab\n* People who do not consent to Prehab, and do not attend Prehab. People who do not consent to surgery\n* People with a high cardiovascular risk for Prehab and awaiting investigations or interventions (including unstable angina and syncope)\n* People with a serious concomitant disorder that would compromise safety during Prehab\n* People with an abdominal hernia or recent abdominal surgery\n* People with a history of spontaneous pneumothorax and\u002For evidence of large bullae on radiological imaging\n* People with an inability to understand written and\u002For spoken English (only if carers are able to translate)\n* People with a perforated ear drum\n* People with worsening heart failure signs and symptoms after IMT\n* People with pulmonary hypertension\n* People who have suffered from or likely to suffer from costochondritis\n* If a participant was involved in a similar study, with potential to cause bias or conflict of interest then they will be excluded","90 Years",{"count":122,"type":21},100,[24],"Smoking is a major cause for developing lung cancer. People diagnosed with lung cancer, may be offered surgery which offers a complete cure. Smoking also damages the lungs and compromises a person's lung function, resulting in shortness of breath. Breathlessness limits the ability to carry out daily physical activities and exercise and makes people vulnerable to developing post procedure complications and even death. Some people with surgically treatable lung cancer have a poor ability to exercise and compromised lung function and are not fit for surgery. They will instead be referred for radiation therapy, chemotherapy or palliative care. Surgery is the preferred treatment option.\n\nThe pulmonary rehabilitation program (Prehab) improves fitness levels. In addition, it improves the level of breathlessness, exercise capacity and vulnerability of people with lung cancer, with the aim of making them fit for safe surgery. By adding a breathing training device to the Prehab program, the investigators aim to further improve participants fitness for surgery, lower their risk of developing complications and the time spent in hospital after the procedure. The breathing training device is called an inspiratory muscle training device. The hand-held device helps to train and strengthen the breathing muscles, which are then able to work more effectively. After the procedure, participants may be able to breathe and exercise more easily reducing their risk of developing complications and improving outcomes.\n\nThe study will compare two groups of people with lung cancer having surgical removal of part of the lung, at a specialist hospital . One group will receive standard Prehab and inspiratory muscle training with the device prior to the procedure; patients in the second group with receive standard Prehab prior to the procedure. Participants will be followed up for twelve months.",[126,127,128,129,130,131],"Cancer","Lung Resection","Inspiratory Muscle Training","Prehabilitation","Respiratory Complications","Length of Hospital Stay",[133,126,134,129,135,136,137],"Inspiratory muscle training","Lung resection","Lung surgery","Randomised control trial","length of hospital stay","RECRUITING","2026-01-28",{"date":141,"type":35},"2026-01-30",{"date":143,"type":35},"2025-05-01",{"date":145,"type":21},"2027-05-01",{"name":41,"class":42},""]