[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Belfast Health and Social Care Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,72,92,112,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591844","phase-3-anti-vascular-endothelial-growth-factor-anti-vegf-monotherapy-vs-anti-vegf-followed-by-subthreshold-micropulse-laser-for-treating-severe-diabetic-macular-oedema-when-the-central-retina-goes-400-microns-100591844",false,"NCT06985706","Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes \u003C400 Microns","Treatment of Severe Diabetic Macular Oedema With Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser When the Thickness of the Central Retina Goes Below 400 Microns: Pragmatic Randomised Equivalence Trial","DAME","Inclusion Criteria:\n\n* Adults (\\>18 years)\n* Diabetes type 1 or type 2\n* Presented with severe centre-involving (CI)-DMO (CRT ≥400 μm)\n* Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 μm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes\n\nExclusion Criteria:\n\n* Causes of macular oedema other than DMO\n* DMO with CRT ≥400 μm\n* Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed)\n* Use of unlicensed anti-VEGFs (e.g. bevacizumab)\n* Inability, for any reason, to attend study visits\n* Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed)\n* Use of pioglitazone which cannot be stopped for the duration of the trial\n* Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks\n* Currently enrolled in a Clinical Trial of an Investigational Medical Product\n* Declined consent for participation","ALL","18 Years",{"count":20,"type":21},264,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (µm), how thick the macula is. One µm is one-thousandth of a millimetre. People presenting with mild DMO (macula less than 400 µm thick; normally it is around 250 µm but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective. However, many people present with severe DMO (macula 400 µm or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again. To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 µm thick.\n\nPatients aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 µm thick.",[27],"Severe Diabetic Macular Oedema",[29,30,31],"Diabetic macular oedema","anti-VEGF","Subthreshold micropulse laser","RECRUITING","2025-09-15",{"date":35,"type":36},"2025-09-19","ACTUAL",{"date":38,"type":36},"2025-05-19",{"date":40,"type":21},"2028-11-30",{"name":42,"class":43},"Belfast Health and Social Care Trust","OTHER",22,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100553215","improving-outcomes-with-act-after-knee-surgery-100553215","NCT06483191","IMProving Outcomes With ACT After Knee Surgery","Acceptability and Feasibility of Acceptance and Commitment Therapy in Total Knee Arthroplasty Patients","IMPACTS","Inclusion Criteria:\n\n* Patients ≥ 18 years old scheduled for routine primary elective TKA.\n* Participants must have a functional level of spoken and written English and be able to complete the online pre-operative psychosocial questionnaire independently.\n* Patients must have scored 10 or more on the Depression subscale of the (Depression, Anxiety and Stress Scale) DASS-21 of the pre-operative psychosocial questionnaire.\n\nExclusion Criteria:\n\n* Any patient who does not have access to a mobile phone to receive the booster text messages, or online facilities to answer online questionnaires.\n* Any patient who has a significant change (≥3 months) in scheduled date of surgery i.e. has a delayed surgery or surgery earlier than expected.\n* Any patient who does not attend the pre-operative education class.\n* Any patient scheduled for revision, uni-compartmental or bilateral TKA.\n* Any patient who has further orthopaedic surgery planned in the next 3 months.\n* Any patient who cannot commit to the schedule of events.\n* Any patient currently receiving any other \"talking therapy\".","100 Years",{"count":55,"type":21},50,[57],"NA","Regarding psychosocial factors and outcomes in total knee arthroplasty (TKA), most of the current literature and the investigators' previous work suggest that depression, anxiety and pre-operative pain strongly predict worse outcomes following TKA. Despite some conflicting evidence, on the whole, the current literature suggests that psychological intervention in TKA patients could help to improve outcomes. In recent years, Acceptance and Commitment Therapy (ACT) has been receiving more attention as it may be more effective than the more traditional cognitive behavioural therapy in treating older people with chronic pain. ACT includes a combination of acceptance and mindfulness methods along with activation and behaviour change methods.\n\nThere have been several studies examining ACT in patients undergoing orthopaedic surgery. These studies have found that attending a pre-operative ACT workshop and receiving text messages reinforcing ACT can reduce use of pain medication, reduce post-operative pain and improve function following surgery. There are also two study protocols published which plan to investigate ACT in TKA patients but the findings of these studies are yet to be reported.\n\nIn this feasibility study, the investigators propose to investigate the acceptability and feasibility of a pre-operative ACT workshop in TKA patients considered to be at risk of poorer outcome based on a depression score. If found to be acceptable and feasible to both patients and those who will deliver the ACT sessions, a larger study will be performed.",[60,61],"Total Knee Arthroplasty","Knee Osteoarthritis","NOT_YET_RECRUITING","2025-05-08",{"date":65,"type":36},"2025-05-13",{"date":67,"type":21},"2025-09",{"date":69,"type":21},"2026-12",{"name":42,"class":43},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":71},"100553214","gait-in-fixed-or-rotating-cementless-total-knee-arthroplasties-100553214","NCT06483178","Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties","A Randomised Controlled Trial Comparing Gait in Fixed or Rotating Cementless Total Knee Arthroplasties","G-FORCE","Inclusion Criteria:\n\n* Patients aged \\\u003C65 years old who require a primary TKA for medial compartment osteoarthritis with a varus deformity.\n* On examination patients must have a pain free ROM of both hips, both ankles and the opposite knee. A history of mild pain in any of these lower limb joints that does not inhibit mobility is acceptable.\n* Must be able to walk at a pre-operative speed of at least 4 km\u002Fh (approximately 30 metres in 30 seconds).\n* Must be able to walk outside unaided or with no more than a walking stick.\n* Must be able to complete pre- and post-operative gait analysis.\n* Participants must have a functional level of spoken and written English and must have a smartphone or have access to a smartphone to complete the online questionnaires on REDCap and to take photographs for virtual assessment of ROM.\n\nExclusion Criteria:\n\n* Patients with valgus deformity of the knee.\n* Patients with previous lower limb arthroplasty.\n* Patients with previous lower limb open reduction and internal fixation (ORIF).\n* Patients who are American Society of Anaesthesiologists (ASA) grade 3 or higher.\n* Patients who are unable to adhere to the trial protocol (due to cognitive impairment, cannot speak English or for any other reason).","65 Years",{"count":82,"type":21},90,[57],"The number of patients requiring knee replacements is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity. Therefore, newer implants, or design features, are introduced on a regular basis to try to improve patient outcomes. In 2013, DePuy Synthes launched the Attune Knee System to provide improved range of motion and address the unstable feeling some patients experience whilst performing everyday activities, such as going down stairs. The Attune cementless rotating platform knee was first implanted in September 2016. In 2004, the first Triathlon total knee designed by Stryker was implanted. Registry figures for both the Attune and Triathlon knees are promising with good implant longevity and outcomes.\n\nThere is only a small amount of literature available on the Attune knee as it is still a relatively new implant. Worldwide, the Triathlon is widely used and is also a well-established, successful implant used in the investigators' unit. This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill, patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee. 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant.",[60,61],{"date":65,"type":36},{"date":88,"type":21},"2025-05",{"date":90,"type":21},"2027-12",{"name":42,"class":43},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":71},"100590025","can-the-use-of-virtual-reality-improve-tka-outcomes-100590025","NCT06962046","Can the Use of Virtual Reality Improve TKA Outcomes","Can the Use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty With Spinal Anaesthesia? - A Pilot Study","VR-TKA","Inclusion Criteria:\n\n* Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.\n\nExclusion Criteria:\n\n* Patients who are ASA grade 3 or 4.\n* Patients who cannot use VR e.g. those with dementia.\n* Patients with an existing diagnosis of delirium.\n* Patients with visual impairment if degree of myopia\u002Fhyperopia exceeds the corrective power of the VR headset.\n* Patients with hearing aids.\n* Patients with previous history of motion sickness.\n* Patients with epilepsy, history of black outs or fitting.\n* Patients who will have an operation over 1 hour in duration or any patient who requires more complex surgery.\n* Patients who have requested no sedation during the operation.\n* Patients who have received premedication.\n* Patients who have a general anaesthetic.\n* Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs.\n* Patients who are not capable of informed consent.",{"count":101,"type":21},40,[57],"Virtual reality (VR) uses computer technology to create a three-dimensional environment which the user can explore and interact with. VR can be used to distract the patient during an operation and has been used to avoid sedative premedication, increase patient satisfaction and decrease pain during nerve blocks. VR used alongside spinal anaesthetic for hip, knee and ankle operations has shown a trend of less sedation being required with no decrease in patient satisfaction.\n\nThe most common type of anaesthesia given during total knee arthroplasty (TKA) is spinal. Spinal anaesthesia is given unless there are complications or other conditions present, and general anaesthesia is given instead. General anaesthesia puts the patient to sleep during the operation, whereas spinal anaesthesia allows the patient to stay awake, but numbs the lower half of the body so no pain is felt. Sedation is usually given with spinal anaesthesia to make the patient relaxed and sleepy. Light sedation will allow the patient to be awake but relaxed, whereas deeper sedation means the patient is more likely to be asleep and less likely to recall what happened during the operation. Sedation can cause a number of side effects including nausea, vomiting, headache, drowsiness, pain, confusion, memory loss and breathing difficulties.\n\nIn this study, all patients will receive spinal anaesthesia. Group 1 will receive VR and a light level of sedation, whilst Group 2 will not receive VR but will receive a deeper level of sedation (standard of care). When using VR during TKA, a lighter level of sedation should be required. This could help to reduce side effects and aid quicker patient recovery. This pilot study aims to investigate this further.",[60],"2025-04-29",{"date":63,"type":36},{"date":108,"type":36},"2024-10-16",{"date":110,"type":21},"2025-12",{"name":42,"class":43},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100564269","phase-1-investigation-of-novel-and-established-therapies-in-a-human-intravenous-lipopolysaccharide-model-of-sepsis-100564269","NCT06626984","Investigation of Novel and Established Therapies in a Human Intravenous Lipopolysaccharide Model of Sepsis","INITIALISE","Inclusion Criteria:\n\n1. Healthy adult volunteers aged between 18 and 40 years of age\n2. Informed consent to participate\n\nExclusion Criteria:\n\n1. Current participation in a clinical trial\n2. Pregnant or breastfeeding\n3. Current history of smoking\n4. Alcohol intake \\> 21 units per week\n5. Regular intake of any relevant prescription or over-the-counter medication. Any regular medication use will be reviewed on a case-by-case basis as to (a) risk and (b) potential confounding effect.\n6. Oxygen saturation \\\u003C95% breathing room air\n7. Abnormal findings on history, examination or laboratory tests suggestive of underlying illness (in the opinion of the clinician undertaking screening)\n8. History of recurrent vaso-vagal episodes\n9. Allergy to Imatinib\n10. Positive or equivocal hepatitis B or C serology result",true,"40 Years",{"count":122,"type":21},65,[124,125],"PHASE1","PHASE2","Sepsis is a common and life-threatening condition caused by a dysregulated host immune response to infection. Given the prominent role of endothelial breakdown and dysfunction in sepsis, therefore, there is an urgent need to establish strategies to protect the endothelium and preserve microcirculatory function.\n\nThis study is a randomised clinical study investigating intravenous fluid therapy and oral imatinib therapy in healthy human volunteers exposed to intravenous lipopolysaccharide (LPS).\n\nThe objective of the study is to investigate the biological effects of fluid and imatinib therapy on LPS-induced microcirculatory dysfunction.",[128,129,130,131],"Sepsis","Fluid Overload","Endothelial Dysfunction","Microcirculation",[133,134],"Intravenous Fluid Therapy","Imatinib","2024-10-02",{"date":137,"type":36},"2024-10-04",{"date":139,"type":21},"2024-12-01",{"date":141,"type":21},"2026-07-01",{"name":42,"class":43},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":71},"100551837","cmr-right-ventricular-contractile-reserve-following-lung-resection-100551837","NCT06465277","CMR Right Ventricular Contractile Reserve Following Lung Resection","Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study","Inclusion Criteria:\n\n* 1\\) Provision of informed consent 2) Age \\>16 years 3) Planned elective\n\n  1. lobectomy lung resection or\n  2. oesophagectomy surgery with one lung ventilation or\n  3. gastrectomy\n\nExclusion Criteria:\n\n1. Pregnancy\n2. On-going participation in any investigational research which could undermine the scientific basis of the study\n3. Atrial fibrillation at baseline\n4. Any contraindication to\n\n   a. CMR, i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in a part of the body b. Dobutamine stress testing as per the Society for Cardiovascular Magnetic Resonance64 i. Severe systemic arterial hypertension (≥220\u002F120 mmHg) ii. Unstable angina pectoris iii. Severe aortic valve stenosis (peak aortic valve gradient \\>60mmHg or aortic valve area \\\u003C 1cm2) iv. Complex cardiac arrhythmias including uncontrolled atrial fibrillation v. Hypertrophic obstructive cardiomyopathy vi. Myocarditis, endocarditis, or pericarditis vii. Uncontrolled heart failure\n5. Lung resection specific\n\n   1. Wedge, segmental or sub-lobar lung resection\n   2. Pneumonectomy\n   3. Isolated right middle lobectomy\n\n      \\-",{"count":151,"type":21},42,"OBSERVATIONAL","Feasibility study investigating CMR dobutamine stress testing before and after lung resection",[155,156,157],"Lung Cancer","Surgery","Anesthesia",{"date":159,"type":36},"2024-10-03",{"date":161,"type":36},"2023-07-21",{"date":163,"type":21},"2024-12",{"name":42,"class":43},""]