[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University College, London\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,115,0,25,[9,43,72,94,126,149,176,202,229,252,279,301,320,348,376,410,438,469,498,527,549,581,607,631,657],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100501440","determining-the-mechanisms-of-loss-of-car-t-cell-persistence-100501440",false,"NCT05809284","Determining the Mechanisms of Loss of CAR T Cell Persistence","CARPERS","Inclusion Criteria:\n\n1. Children and young adults (age 25 years or younger) with relapsed\u002Frefractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)\n2. Written informed consent\n\nExclusion Criteria:\n\n1. Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial\n2. Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol","ALL","25 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.",[25,26,27,28,29],"Acute Lymphoblastic Leukemia With Failed Remission","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia, Pediatric","Acute Lymphoblastic Leukemia, Adult","Acute Lymphoblastic Leukemia, in Relapse","RECRUITING","2026-08-06",{"date":33,"type":34},"2026-08-07","ACTUAL",{"date":36,"type":34},"2023-10-18",{"date":38,"type":21},"2027-07-01",{"name":40,"class":41},"University College, London","OTHER",3,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100481094","phase-1-car-t-cells-to-target-gd2-for-dmg-100481094","NCT05544526","CAR T Cells to Target GD2 for DMG","Chimeric Antigen Receptor (CAR)-T Cells to Target GD2 for Diffuse Midline Glioma","CARMIGO","Inclusion Criteria:\n\n1. Age ≥ 2 and ≤ 16 years\n2. Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.\n3. Radiographically evident tumour restricted to the brain stem or spinal cord.\n4. At least 6 weeks following completion of radiation therapy.\n5. At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial\n6. Performance status: Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10) score ≥ 40% allowing for stable neurological deficit due to DMG\n7. Absolute neutrophil count ≥1.5 x109\u002FL and platelet count ≥ 100 x109\u002FL\n8. Total bilirubin \\\u003C 1.5 ULN and ALT \\\u003C 2.5 ULN\n9. Serum creatine \\\u003C 1.5 ULN for age.\n10. For post-pubertal subjects agreement to have a pregnancy test, use adequate contraception (if applicable)\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Systemic corticosteroid therapy ≥ 0.05 mg\u002Fkg dexamethasone daily (or equivalent) at time of RQR8\u002FhuK28Z CAR T cell infusion\n2. Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)\n3. Clinical or radiological evidence of true tumour progression\n4. Active hepatitis B, C or HIV infection\n5. Inability to tolerate leukapheresis\n6. Pre-existing significant neurological disorder not related to DMG\n7. Clinically significant systemic illness or medical condition (e.g., significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.\n8. Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC\n9. Any contraindication to the use of Anticoagulant Citrate Dextrose Solution\n10. Any contraindication to Ommaya reservoir insertion (or similar catheter)\n11. Known allergy to albumin, DMSO or EDTA\n12. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression \u002Fsystemic disease modifying agents within the last 2 years\n13. Prior treatment with investigational or approved gene therapy or cell therapy products\n14. Life expectancy \\\u003C3 months\n15. Use of rituximab (or rituximab biosimilar) within the last 3 months prior to RQR8\u002FhuK28Z CAR T cell infusion\n16. Post-pubertal subjects who are pregnant or breastfeeding","16 Years",{"count":53,"type":21},12,"INTERVENTIONAL",[56],"PHASE1","The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma (DMG).\n\nThe study will evaluate the feasibility of generating the ATIMP, the safety and tolerability of the GD2CAR T-cell therapy and how effectively GD2CAR T-cells engraft, expand and persist following administration in patients with DMG.",[59],"Diffuse Midline Glioma, H3 K27M-Mutant",[61,62,63],"CAR T cells","Diffuse Midline Glioma","DMG",{"date":65,"type":34},"2026-08-11",{"date":67,"type":34},"2023-08-15",{"date":69,"type":21},"2042-08",{"name":40,"class":41},1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":54,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":71},"100469337","phase-1-allogeneic-t-cells-expressing-t-cell-receptor-kdel-and-the-chimeric-antigen-receptor-cat19-for-the-treatment-of-advanced-cd19-malignancies-100469337","NCT05391490","Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies","KCAT19","Inclusion Criteria:\n\n1. Age 16-65 years\n2. Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy:\n\n   B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed\u002Frefractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed\u002F refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed \u002F refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine.\n3. CD19+ disease\n4. Agreement to have a pregnancy test, use adequate contraception (if applicable)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. CD19 negative disease\n2. Active CNS involvement of disease\n3. Diagnosis of chronic lymphocytic leukaemia\u002F small lymphocytic lymphoma or Burkitt lymphoma\n4. Active hepatitis B, C or HIV infection\n5. Oxygen saturation ≤ 90% on air\n6. Bilirubin \\>2 x upper limit of normal\n7. GFR \\\u003C30ml\u002Fmin\n8. Women who are pregnant or breast feeding\n9. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate\u002Fsevere chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and\u002For systemic steroids\n10. Karnofsky score \\\u003C60%\n11. Known allergy to albumin or DMSO\n12. Patients receiving corticosteroids at a dose of \\>5 mg prednisolone per day (or equivalent) that cannot be discontinued\n13. Life expectancy \\\u003C3 months\n14. Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \\\u003C40%\n15. Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\\*\n\n    * These patients will be initially considered for autologous treatment in preference to enrolling on KCAT19","65 Years",{"count":53,"type":21},[56],"KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed\u002Frefractory (r\u002Fr) B cell malignancies.",[84],"Blood Cancer",[61,86,87],"leukemia","lymphoma",{"date":65,"type":34},{"date":90,"type":34},"2023-02-06",{"date":92,"type":21},"2040-02",{"name":40,"class":41},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":101,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":54,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100650803","phase-3-evaluating-hormone-therapy-to-achieve-optimal-doses-in-metastatic-prostate-cancer-100650803","NCT07751133","Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer","ENHANCE","Inclusion Criteria:\n\n1. Adult males (male sex at birth) aged 18 years or older\n2. Newly histologically or cytologically diagnosed prostate cancer (adenocarcinoma) that is metastatic hormone-sensitive (mHSPC) or metastatic castration resistant prostate cancer (mCRPC), for whom ARPI in combination with androgen deprivation is clinically planned\n3. Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started less than 12 weeks prior to randomisation in mHSPC, (b) In the adjuvant setting the completion of adjuvant hormonal therapy was \\>12 months prior to randomisation and total duration is capped at 36 months total\n4. ECOG performance status 0-2\n5. Willing and able to give provide written informed consent.\n\nExclusion Criteria:\n\n1. Pathology other than adenocarcinoma consistent with small cell, ductal, sarcomatoid carcinoma of the prostate\n2. Unable or unwilling to receive concurrent ADT alongside an ARPI\n3. Any concurrent or previous malignancy that required active anti-cancer therapy in the previous 2 years of randomisation (other than basal cell or squamous cell carcinoma of the skin or adequately treated non-muscle invasive urothelial bladder carcinoma, Tis, Ta and T1 tumours)\n4. Adults with unmanaged psychological, familial, or sociological conditions precluding them from the ability to provide informed consent or hampering compliance with the study follow-up, including continued drug and alcohol dependence\n5. Patients who have received an investigational drug (either approved or not approved) in any prior clinical study within 30 days or 5 half-lives (whichever is longer) prior to Screening\n6. Patients on triplet therapy (i.e. receiving additional systemic anti-cancer therapy such as chemotherapy, radionuclide\u002Fmolecular radiotherapy, PARPi alongside ADT \\& ARPI); but concomitant radiotherapy is allowed\n7. Hypersensitivity to any of the active components or excipients of the IMPs or NIMPs listed in this protocol\n8. Patients with severe hepatic impairment (Child-Pugh Class C)\n9. Patients with uncontrolled or unstable cardiovascular disease, New York Heart Association congestive cardiac failure class III\u002FIV","MALE","18 Years",{"count":104,"type":21},1500,[106],"PHASE3","The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are:\n\n1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and\n2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose.\n\nParticipants will:\n\n* Be randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI.\n* Receive standard of care ADT.\n* Be on treatment for approximately 3 years according to standard of care.\n* Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected.\n* Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64.\n* Keep a diary of their symptoms.\n\nTranslational research samples will be collected as follows:\n\n* Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression.\n* Urine samples at week 0 (pre-treatment) and week 24 and at disease progression.\n* FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).",[109,110,111],"Prostate Cancer","mHSPC","mCRPC",[113,114,115,116,117,118],"Prostate cancer","Metastatic","ARPI","ADT","Androgen Receptor Pathway Inhibitor","Androgen Deprivation Therapy","NOT_YET_RECRUITING","2026-08-03",{"date":33,"type":34},{"date":120,"type":21},{"date":124,"type":21},"2033-08-01",{"name":40,"class":41},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":54,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100650786","phase-1-multi-modular-chimeric-antigen-receptor-t-cells-targeting-b7-h3-in-children-teenage--young-adult-sarcoma-100650786","NCT07751380","Multi-modular Chimeric Antigen Receptor T Cells tarGeting B7-H3 in Children, Teenage & Young Adult Sarcoma","MIGHTY","Inclusion Criteria:\n\n1. Age ≥ 1 and ≤ 24 years.\n2. Tissue diagnosis of RMS, ES or DSRCT\n3. Expression of B7-H3 in the tumour\n4. Relapsed or refractory disease after one or multiple lines of previous treatment.\n5. Measurable disease by cross sectional imaging. Patients with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study.\n6. At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial.\n7. Performance status: Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10) score ≥ 50%.\n8. Creatinine ≤1.5 x Upper Limit of Normal (ULN) for age, if higher, an estimated (calculated) creatinine clearance must be ≥ 60 ml\u002Fmin\u002F1.73 m2.\n9. Left ventricular ejection fraction (LVEF) ≥ 50%\n10. Absolute lymphocyte count ≥ 0.25 x 109\u002FL.\n11. Women of childbearing potential (WOCBP) must have a negative pregnancy test and agree to comply with the pregnancy reporting requirements of the protocol (if applicable).\n12. Written informed consent.\n\nExclusion Criteria:\n\n1. Patients with only bone marrow detectable disease in the absence of measurable disease by cross sectional imaging.\n2. Patients with active, inoperative central nervous system (CNS) disease including leptomeningeal disease.\n3. Active hepatitis B, C or HIV infection.\n4. Inability to tolerate leukapheresis.\n5. Clinically significant systemic illness or medical condition (e.g., significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.\n6. Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC.\n7. Any contraindication to the use of Anticoagulant Citrate Dextrose Solution.\n8. Known allergy to albumin, EDTA or DMSO.\n9. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression \u002Fsystemic disease modifying agents within the last 2 years.\n10. Prior treatment with investigational or approved gene therapy or cell therapy products.\n11. Life expectancy \\\u003C3 months.\n12. Systemic corticosteroid therapy ≥ 0.05 mg\u002Fkg dexamethasone daily (or equivalent) at time of hBRCA84D CAR T cells infusion.\n13. Women who are pregnant or breastfeeding.\n14. Patients who have received any live vaccine in the six weeks prior to planned lymphodepletion\n\nExclusion criteria for the ATIMP infusion:\n\n1. Uncontrolled fungal, bacterial, viral, or other infection. Previously diagnosed infection for which the patient continues to receive antimicrobial therapy is permitted if responding to treatment and clinically stable at the time of scheduled hBRCA84D CAR T cell infusion.\n2. Systemic corticosteroid therapy ≥ 0.05 mg\u002Fkg dexamethasone daily (or equivalent) at time of hBRCA84D CAR T cell infusion.","1 Year","24 Years",{"count":53,"type":21},[56],"MIGHTY is a multicentre, open label, phase 1 clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children, teenagers and young adults aged 1-24 with relapsed or refractory (r\u002Fr) rhabdomyosarcoma (RMS), Ewing sarcoma (ES) or desmoplastic small round cell tumour (DSRCT).\n\nThe study will assess the feasibility of generating the ATIMP and administering hBRCA84D CAR T cells to patients with r\u002Fr RMS, ES or DSRCT.",[139],"Sarcoma",[141,61],"sarcoma",{"date":33,"type":34},{"date":144,"type":34},"2025-07-23",{"date":146,"type":21},"2042-07",{"name":40,"class":41},2,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":54,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":71},"100635223","middle-meningeal-artery-coagulation-during-burr-hole-drainage-for-chronic-subdural-haematoma-burr-mma-100635223","NCT07549893","Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BURR-MMA)","BURR-MMA: A Prospective Pilot Feasibility Study of Intra-operative Middle Meningeal Artery Coagulation During Burr-Hole Surgery for Chronic Subdural Haematoma","BURR-MMA","Inclusion Criteria:\n\n* Age ≥18 years.\n* Chronic or subacute subdural haematoma scheduled for burr-hole evacuation.\n* Treating surgeon considers the CT- and navigation-guided MMA adjunct technically feasible and safe to attempt, recognising that the adjunct may be abandoned intra-operatively according to protocol bail-out criteria.\n* Written informed consent, or consultee declaration under the Mental Capacity Act (MCA), with re-consent if capacity returns.\n\nConsented participants who meet eligibility criteria will be enrolled sequentially until the target sample size of 20-30 participants is reached. No randomisation is used in this feasibility phase.\n\nExclusion Criteria:\n\n* Acute subdural haematoma requiring craniotomy or decompressive surgery.\n* Prior ipsilateral MMA embolisation.\n* Clear contraindication to pre-operative CT\n* Inability to complete Day-90 follow-up.\n* Pregnancy or breastfeeding (due to radiation exposure from CT imaging as part of standard clinical care).\n\nIf CT is non-diagnostic or cannot be performed, participants will continue with standard burr-hole evacuation without the MMA adjunct; this does not constitute a protocol deviation.",{"count":158,"type":21},30,[160],"NA","Chronic subdural haematoma (cSDH) is a common condition in older adults, usually treated by burr-hole surgery to drain the collection. Even with good surgery, around 1 in 10 patients develop a recurrence and need a second operation. Research shows that the outer lining of the haematoma is fed by small branches of the middle meningeal artery (MMA), and interrupting these branches may lower the risk of recurrence.\n\nThis study looks at whether surgeons can safely and reliably coagulate these small MMA branches at the same time as standard burr-hole drainage, using the routine pre-operative CT scan and surgical navigation already used in everyday practice. Adults (aged 18 years and over) scheduled for burr-hole drainage of a chronic or subacute subdural haematoma will be invited to take part. The procedure, recovery, drain management, and 90-day follow-up will otherwise follow standard NHS care.\n\nNo additional imaging is required for the study, and participants are not exposed to any extra radiation. The main purpose is feasibility and safety, not to prove effectiveness. Findings will inform the design of a future multicentre study.",[163],"Chronic Subdural Hematomas",[165,166,167],"chronic subdural haematoma","middle meningeal artery","burrholes","2026-07-31",{"date":170,"type":34},"2026-08-04",{"date":172,"type":21},"2026-08-01",{"date":174,"type":21},"2027-12-01",{"name":40,"class":41},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":54,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":71},"100603342","bespoke-decision-support-for-patients-with-newly-diagnosed-localised-prostate-cancer-100603342","NCT07135271","BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer","Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis","BeSpoke","Inclusion Criteria for Patient-Participants:\n\n1. Newly diagnosed localised prostate cancer\n2. Clinically suitable for at least two of the following treatment options:\n\n   1. active surveillance\n   2. focal therapy\n   3. radical prostatectomy\n   4. external beam radiotherapy\n3. Willing and able to provide informed consent\n\nExclusion Criteria for Patient Participants:\n\n1. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.\n2. Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:\n\n   1. Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET\u002FCT;\n   2. PSA ≥50 ng\u002FmL.\n3. Not able to provide informed consent.\n4. Insufficient English proficiency for adequate use of BeSpoke Decision Support. (Patients with support from a family member, friend or partner, to overcome lack of English proficiency will be included.)\n5. Enrolled in other localised prostate cancer studies where treatment is assigned rather than chosen by participants, e.g. PART Trial (Partial prostate Ablation vs Radical prostaTectomy)\n\nInclusion criteria for Health Care Professionals:\n\n1. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.\n2. Willing and able to provide written or electronic informed consent\n\nExclusion criteria for Health Care Professionals\n\n1\\. No experience of BeSpoke Decision Support.",{"count":185,"type":21},346,[160],"The goal of this randomised clinical trial is to assess whether personalised treatment counselling can improve the decision-making experience in patients with a new diagnosis of localised prostate cancer. The main question it aims to answer is:\n\n• Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer?\n\nResearchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone.\n\nPatient participants will:\n\n* Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision.\n* Answer to questionnaires regarding urinary, sexual and bowel function and decision-making outcomes before and after making a treatment decision and at 3, 6, and 12 months after initiating treatment.\n* Take part in a qualitative interview to discuss their decision-making experience\n\nHealth Care Professional participants will:\n\n• Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.",[189],"Localised Prostate Cancer",[189,191,192,193],"Patient Decision Aid","Shared Decision Making","Randomised Clinical Trial","2026-07-28",{"date":196,"type":34},"2026-07-29",{"date":198,"type":34},"2026-07-22",{"date":200,"type":21},"2028-12",{"name":40,"class":41},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":54,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100648769","phase-3-apixaban-to-prevent-decompensation-of-early-liver-cirrhosis-trial-100648769","NCT07726693","Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial","Apixaban to Prevent dEcompensation of eArly Liver CirrHosis Trial","APEACH","Inclusion Criteria:\n\n1. Liver cirrhosis secondary to alcohol, with or without associated metabolic risk factors, i.e. Alcohol related liver disease (ARLD) or metabolic dysfunction-associated steatotic liver disease, where there has been a significant history of alcohol consumption (MetALD)\n2. Cirrhosis will be based on histology, or clear radiological evidence, e.g. nodular or heterogeneous liver or non-invasive testing (e.g. Fibroscan®, or Enhanced Liver Fibrosis (ELF) test\n3. Childs A Cirrhosis (Participants with a previous episode of decompensated cirrhosis who have now recompensated can be included)\n4. Participants with no hepatic encephalopathy or low-grade hepatic encephalopathy (Grade 0 or 1) taking lactulose and\u002For rifaximin\n5. Aged ≥18 years\n6. Clinical evidence of portal hypertension, defined as any 1 of:\n\n   * Evidence of abdominal collateral circulation, recanalised umbilical vein or varices on imaging\n   * Asymptomatic ascites (trace only) seen around the liver on imaging in patients who are not taking diuretics\n   * Liver stiffness measurement \\>20kPa on FibroScan®\u002F Vibration- Controlled Transient Elastography (VCTE) (where BMI \\\u003C35)\n   * Presence of Gastro-oesophageal varices at endoscopy\n   * Hepatic venous pressure gradient ≥ 10mmHg\n\nOr Platelet count \\\u003C 150,000 μL AND any 1 of:\n\n* Spleen size \\>13 cm in length\n* Liver stiffness measurement \\>20kPa on FibroScan®\u002FVCTE (where BMI \\>35)\n* Presence of portal hypertensive gastropathy at endoscopy\n\nExclusion Criteria:\n\n1. Evidence of decompensation (e.g. ascites requiring treatment other than a thin rim around liver on imaging, as above) (Evidence of decompensation as follows: Grade 2 or 3 Ascites, Grade 2 - 4 Hepatic Encephalopathy, Variceal Haemorrhage)\n2. Causes for cirrhosis other than alcohol, including those with MASLD who have never drunk alcohol above government recommended levels (14 units\u002Fweek)\n3. Pre-existing splanchnic vein thrombosis (portal, splenic, mesenteric, and hepatic veins)\n4. Use of (and need for) anticoagulation or dual antiplatelet therapy or clopidogrel\n5. Platelets \\\u003C50x109\u002FL at screening\n6. Moderate-severe renal impairment defined as eGFR \\\u003C30ml\u002Fmin at screening\n7. Recent variceal bleed or untreated large varices\n8. Malignancy in last 2 years if unlikely to survive trial because of comorbidity in the location PI's opinion\n9. Hepatocellular carcinoma\n10. Severe cardiac failure1 or Chronic Obstructive Pulmonary Disease (COPD)\n11. Pregnancy\n12. INR \\>1.7 (After vitamin K correction) at screening\n13. Previous hypersensitivity reaction to Apixaban",{"count":211,"type":21},1142,[106],"Liver disease is the only common cause of death that is increasing in numbers. Once people develop severe scarring (cirrhosis), there are no medications proven to help them live longer, healthier lives. Apixaban is already commonly used to prevent or treat blood clots and is known to be safe for those with cirrhosis.\n\nIn the early stages of cirrhosis, most people have no symptoms and lead normal lives; this is called \"compensated\" cirrhosis. However, when the liver stops working properly, they develop \"decompensated\" cirrhosis, which causes yellow skin, confusion, vomiting of blood and painful fluid build-up. This is serious, and people are extremely unwell with a poor quality of life, often need to go to the hospital and on average only live for 2 more years.\n\nThe APEACH trial will investigate whether giving compensated cirrhosis patients Apixaban will help stop them from developing decompensated cirrhosis and stay in good health for longer.\n\nPrevious research studies suggest that taking blood-thinning drugs is safe and helpful for cirrhosis. However, these did not have enough participants to be confident enough in the results to recommend use in everyday clinical care.\n\nThe APEACH trial will include enough participants to make it clear whether Apixaban is helpful or not.",[215],"Liver Cirrhosis",[215,217,218,219,220],"Alcohol Related Liver Disease (ARLD)","Metabolic dysfunction-associated steatotic liver disease","Apixaban","MetALD","2026-07-21",{"date":223,"type":34},"2026-07-24",{"date":225,"type":21},"2026-07-15",{"date":227,"type":21},"2031-03-30",{"name":40,"class":41},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":54,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":251,"locationsCount":148},"100648491","phase-3-an-evaluation-of-treatments-for-sustained-clinical-response-18-months-in-symptomatic-alzheimers-disease-100648491","NCT07724132","An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease","Alzheimer's Disease- Systematic Multi-Arm Adaptive Randomised Trial","AD-SMART","Inclusion Criteria\n\n* Patient meets all inclusion criteria:\n\n  1\\. Adults aged ≥55 years on the day of screening, no upper age limit 2. Either:\n  1. Confirmed clinical diagnosis of Alzheimer's Disease (AD)\n  2. Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vascular Dementia 3. Mini Mental State Examination score of ≥17 4. Confirmatory blood biomarker testing (pTau-217) (positive or intermediate via validated assays) ≤ 365 days prior to screening or between screening and randomisation or a positive amyloid PET scan (if available) or a positive amyloid CSF test (if available) 5. Randomisation should ideally take place within 4 weeks of the screening visit but no later than 8 weeks after the screening visit 6. Must be able and willing to comply with the treatment and assessment schedule and requirements including being able to start trial treatment ≤ 2 weeks after randomisation 7. Willing and able to have MRI scans in accordance with the assessment schedule unless participant is clinically contraindicated due to:\n\n  \u003C!-- -->\n\n  1. Pacemakers or defibrillators (unless MRI-conditional models)\n  2. Aneurysm clips, stents or metal implants (unless MRI safe)\n  3. Cochlear implants (unless MRI-conditional models)\n  4. Metal fragments in the body\n  5. Severe claustrophobia 8. Negative pregnancy test ≤4 weeks prior to randomisation for women of child-bearing potential 9. Normal liver function at screening consisting of all the following:\n\n  \u003C!-- -->\n\n  1. Total serum bilirubin \\\u003C1.5 x ULN (except for participants with Gilbert's disease, for whom the upper limit of total serum bilirubin is 51.3 μmol\u002Fl or 3mg\u002Fdl)\n  2. Alanine aminotransferase (ALT) \\\u003C3 x ULN;\n  3. Alkaline phosphatase \\\u003C3 x ULN 10. Documented participant and study partner informed consent 11. If a participant is being re-randomised into the trial, additional timing of entry requirements must also be met:\n\n  \u003C!-- -->\n\n  1. For participants being re-randomised after completing 18 months' follow-up and the arm was not closed due to lack of activity, a 12-week washout period from last dose of IMP must be completed before their screening visit. If the efficacy analysis indicates that the IMP was ineffective then this washout period can be reduced to 6 weeks.\n  2. For participants being re-randomised following treatment arm termination due to lack of activity, a 6-week washout period from their last dose of IMP must be completed prior to screening assessment\n\n     Study Partner inclusion criteria:\n     1. Participant that meets the AD-SMART eligibility criteria has consented to participation in the trial\n     2. Has at least twice-weekly contact with participant\n     3. Be 18 years or older at the time of providing consent\n     4. Willing to complete study partner questionnaires as outlined in visit schedule\n     5. Willing to attend remote and in-person study visits with participant\n     6. Documented informed consent\n\n     Exclusion Criteria:\n* Patient meets none of the exclusion criteria:\n\n  1. Fazekas Score =3 reported from an MRI taken at any time prior to randomisation, if an MRI is not clinically contraindicated (reasons specified in Inclusion Criteria 7) A. MRI does not need to be repeated if Fazekas score = 0, 1 or 2 reported from an MRI performed ≤365 days to screening visit (if Fazekas score has not been reported, refer to Section 7.4) b. MRI should be conducted if participant is not clinically contraindicated to MRIs and previous MRI where Fazekas score = 0, 1 or 2 was \\>365 days or previous MRI scan is not available for Fazekas score reporting or participant has never had an MRI\n  2. Clinical diagnosis of Dementia with Lewy bodies\n  3. Clinical diagnosis of Parkinson's disease\n  4. Clinical diagnosis of Frontotemporal Dementia\n  5. Cardiac failure (American Heart Association Stage C or D)\n  6. Significant respiratory comorbidity (hospitalisation within the previous ≤6 months due to respiratory comorbidity)\n  7. Renal failure (CKD IV or eGFR ≤45 mL\u002Fmin\u002F1.73m²) at any time point prior to randomisation\n  8. Malignancy (except if in complete remission) e.g. solid organ or haematological or melanoma\n  9. Score of ≥1 on C-SSRS at screening visit\n  10. Individuals without an identified study partner (refer to Section 4 for further details on study partners)\n  11. Individuals who have an Alzheimer's Disease or Central Nervous System medication (e.g. antidepressant) change or dose change ≤28 days prior to screening\n  12. Use of an Investigational Medicinal Product (IMP) or Investigational Medical Device (IMD) ≤26 weeks prior to randomisation (except for AD-SMART participants that are being re-randomised. See Section 5.4 for further information).\n  13. Receiving antibody-based amyloid clearing treatment for Alzheimer's Disease within 26 weeks prior to randomisation\n  14. Unable or unwilling to comply with study procedures\n  15. Unable to swallow whole capsules\n  16. Individuals who are living in the same household as an AD-SMART participant who is actively taking trial medication\n  17. Female participants that are pregnant or breastfeeding\n  18. Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception (see acceptable methods of contraception) whilst on trial treatment and up to 12 weeks after the last dose of study drug\n  19. Male participants with a partner of child-bearing potential unwilling or unable to use an acceptable method of contraception whilst on trial treatment and up to 12 weeks after the last dose of the study drug.\n  20. Male participants unwilling to desist from sperm donation during the trial and for 12 weeks after the last dose of trial treatment\n  21. Current or previous exposure to any of the currently recruiting AD-SMART IMPs ≤26 weeks before randomisation.\n  22. History of alcohol and\u002For drug abuse and\u002For dependence within the 5 years prior to screening visit.\n  23. Any concurrent medical condition, abnormal laboratory tests or uncontrolled, clinically significant systemic disease that, in the opinion of the Investigator, could cause study participation to be detrimental to the participant.\n  24. Participants who are not eligible for any of the trial IMPs, according to the eligibility criteria listed in the individual drug appendices. Please note that participants can enter the trial if they are eligible for at least one of the trial treatment arms, but do not need to be eligible for all.\n\nArm-specific eligibility criteria:\n\nAtomoxetine-specific exclusion eligibility criteria:\n\nIn addition to the core inclusion and exclusion criteria, refer to section 2.2 of AD-SMART Appendix 1 Atomoxetine' for the arm-specific exclusion eligibility criteria for the Atomoxetine arm which must also be met.\n\nMetformin-specific exclusion eligibility criteria:\n\nIn addition to the core inclusion and exclusion criteria, refer to section 2.2 of AD-SMART Appendix 2 Metformin' for the arm-specific exclusion eligibility criteria for the metformin arm which must also be met.","55 Years",{"count":239,"type":21},1200,[106],"A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.",[243,244,245],"Alzheimer's Disease (AD)","Mild Cognitive Impairment Due to Alzheimer's Disease","Alzheimer Disease Dementia",{"date":247,"type":34},"2026-07-23",{"date":223,"type":21},{"date":250,"type":21},"2031-03",{"name":40,"class":41},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100645739","perioperative-medicine---metabolic-inflexibility-as-a-mechanism-for-myocardial-injury-after-non-cardiac-surgery-100645739","NCT07694453","PeriOperative Medicine - Metabolic Inflexibility as a Mechanism for Myocardial Injury After Non-Cardiac Surgery","POM-MIMICS","Inclusion Criteria:\n\n* Adults aged 18 or over\n* Scheduled for major elective abdominal cancer surgery with planned overnight admission\n* Scheduled for pre-operative CPET\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Emergency surgery\n* Unable or unwilling to undergo CPET\n* Pregnancy\n* Active sepsis\n* End-stage organ failure (e.g. on dialysis)\n* Participants without the mental capacity to consent\n* Diagnosis of Type 1 Myocardial Infarction meeting the 4th Universal Definition criteria during the immediate pre-operative period. (Note: Added based on MINS definition context)",{"count":260,"type":21},300,"The goal of this observational study is to learn whether metabolic inflexibility, which means reduced ability of the body to switch between using fats and sugars for energy, is associated with myocardial injury after non-cardiac surgery (MINS) in adults undergoing major elective abdominal cancer surgery.\n\nThe main question it aims to answer is:\n\nDoes pre-operative metabolic inflexibility predict myocardial injury after non-cardiac surgery (MINS) within the first 72 hours after surgery?\n\nParticipants will continue with their usual surgical care and pre-planned CPET (which can measure metabolic flexibility). As part of the study, participants will:\n\n* Have additional blood samples taken before and after surgery\n* Have an echocardiogram and, where possible, muscle ultrasound\n* Wear a wrist-worn activity monitor before surgery\n* Have routine clinical and surgical information collected from their medical records\n* Receive a follow-up phone call around 90 days after surgery",[263],"MINS",[263,265,266,267,268,269,270],"metabolic flexibility","CPET","Cardiopulmonary Exercise Testing","abdominal cancer surgery","Perioperative medicine","Troponin","2026-07-13",{"date":273,"type":34},"2026-07-14",{"date":275,"type":21},"2026-10-01",{"date":277,"type":21},"2030-10-01",{"name":40,"class":41},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":54,"phases":289,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100634405","phase-2-to-establish-whether-dapagliflozin-and-spironolactone-in-patients-with-severe-aortic-stenosis-undergoing-aortic-valve-replacement-result-in-better-left-ventricular-mass-regression-myocardial-health-and-patient-reported-outcomes-100634405","NCT07539259","To Establish Whether Dapagliflozin and Spironolactone in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement, Result in Better Left Ventricular Mass Regression, Myocardial Health and Patient Reported Outcomes","Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial","RELIEF-AS","Inclusion Criteria:\n\n* Participants ≥ 18 years\n* Left Ventricular Ejection Fraction (LVEF) ≥40%.\n* Diagnosed with severe symptomatic aortic stenosis\\* by a cardiologist or cardiac surgeon.\n\n  o Severity of AS follows international guideline criteria \\[38\\], namely at least one out of: effective orifice area \\[EOA\\] \\\u003C1.0 cm2, indexed EOA of ≤0.6 cm2\u002Fm2, peak velocity ≥4.0 m\u002Fs or mean gradient \\>40 mmHg. \\* including severe low flow low gradient AS\n* Referred for surgical or transcatheter AVR (SAVR or TAVI).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Current use or intolerance or hypersensitivity to MRAs or SGLT2-inhibitors.\n* Hyperkalaemia (K\\>4.5 mmol\u002FL)\n* Significant renal impairment (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic insufficiency\n* Concomitant severe other valve lesion (severe MR, MS or AR)\n* Contraindications to MRAs including:\n\n  * Addison's disease.\n  * Acute porphyrias.\n  * Receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP 3A4 (for example. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).\n* Contraindications to SGLT2-inhibitors including:\n\n  * Active urinary tract infections.\n  * At risk or with a history of diabetic ketoacidosis\n* Type 1 or Type 2 Diabetes on insulin.\n* Concomitant diagnosis affecting trial participation or life expectancy of less than two years as evaluated by the treating clinician.\n* Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet local safety rules for MRI). NB: Conditional pacemakers\u002FICDs, if implanted after the baseline scan, are not an exclusion, depending on local expertise.\n* Ongoing participation in another CTIMP interventional clinical trial (i.e. drug trial), will not be permitted. Participation in any other trial will need to be discussed with the trial investigators.\n* Significant comorbidities that would contraindicate participation, including uncontrolled hypertension, or recent myocardial infarction (within 3 months prior to screening).\n* Pregnancy or breastfeeding, or females of childbearing potential not using an effective method of contraception.\n* Any other medical or psychiatric condition that would interfere with participation or compliance with study procedures as determined by the Principal Investigator (PI).\n\n  * As evidenced by features of decompensated cirrhosis e.g. hepatic encephalopathy, ascites, jaundice or markedly deranged liver blood tests e.g. elevated bilirubin, serum albumin \\\u003C30 or deranged clotting",{"count":288,"type":21},445,[290],"PHASE2","This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.\n\nEven after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.\n\nThis study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.\n\nThere will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.\n\nParticipants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.\n\nThese medicines might help patients after AVR by reducing heart muscle thickness and scarring.",[293],"Aortic Stenosis","2026-07-10",{"date":271,"type":34},{"date":297,"type":21},"2026-12",{"date":299,"type":21},"2030-02-28",{"name":40,"class":41},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":71},"100487537","tracking-thoracic-cancer-evolution-through-therapy-rx-evo-100487537","NCT05628376","TRAcking Thoracic Cancer Evolution Through Therapy (Rx) EVO","Inclusion Criteria:\n\n* Cohort A, B and C :\n\n  * Written Informed consent\n  * Agreement to be followed up (including on-study assessments and sample collection) every 3 months in the first 2 years and then 6 monthly.\n  * Agreement to be followed up at a TRACERx EVO site\n\nCohort A:\n\n* Participants ≥18 years of age, with early stage I-IIIB NSCLC disease who are eligible for primary surgery\n* Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g., diagnosis determined from frozen section in theatre)\n* Primary surgery in keeping with NICE guidelines (lobectomy, either open or thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge resection) if a complete resection can be achieved, extensive surgery (bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain clear margins, hilar and mediastinal lymph node sampling or en bloc resection)\n* For participants proceeding with upfront primary surgery (i.e. no neoadjuvant therapy), a minimum tumour diameter of at least 15mm on imaging to allow for tissue sampling of at least two tumour regions; this can either be two fresh tissue samples or one fresh tissue sample plus one representative diagnostic FFPE block (to be requested at a later date according to trial specific procedures)\n* Participants undergoing neoadjuvant treatment must have at least 1 region of fresh frozen or FFPE surgical or diagnostic biopsy tissue.\n* Considered sufficiently fit for upfront standard of care primary surgery or neoadjuvant therapy if indicated\n* Performance status 0 to 2\n\nCohort B:\n\n* Participants ≥18 years of age, with late-stage unresectable stage IIIB and above NSCLC disease (TNM 8th edition) or presenting with stage IV de novo metastatic disease.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2 Participants who were initially consented into Cohort A who are found to have more advanced disease pre- or immediately post operatively (e.g. locally advanced\u002Finoperable or stage IV disease) could be included in Cohort B.\n\nCohort C:\n\n* Participants ≥18 years of age, with any stage SCLC or pleural mesothelioma.\n* Sufficient tissue (at least 1 region\u002Fbiopsy), either FFPE or fresh frozen\n* Deemed to be fit for anti-cancer treatment\n* Performance status 0 to 2\n\nExclusion Criteria:\n\n* Cohort A, B and C:\n\n  * Any other active or current malignancy and\u002For systemic treatment (excluding hormone therapy) for that malignancy in the last 12 months (i.e., participant must be cancer free for the last 12 months, and if on therapy it can only be hormone therapy).\n\n    * Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer, or for Cohort C, cases of NSCLC that have transformed to SCLC, or for Cohort A another synchronous lung cancer.\n  * Psychological condition that would preclude informed consent\n  * Diagnosis other than NSCLC, SCLC or pleural mesothelioma confirmed following surgery or biopsy\n  * Confirmed diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with research staff, local mortuary staff and pathologist.\n  * Contra-indicated severe co-morbid conditions\n\nCohort A:\n\n* Positive margins, incomplete resection or insufficient nodal sampling\n* Insufficient tissue, i.e., for participants having upfront surgery and not having neoadjuvant therapy, a minimum of two tumour regions unlikely to be obtained for the study based on pre-operative imaging, or for participants having neoadjuvant therapy at least one tissue biopsy unable to be obtained prior to neoadjuvant therapy (Fresh Frozen or FFPE).\n* Participant found to have pre-invasive lesions rather than invasive cancer following surgery, such as adenocarcinoma in situ or minimally invasive lesions will be withdrawn. However, the surgical tissue and baseline blood already collected will be sent to the central laboratory. These participants will not be followed-up in the study or required to provide any further blood samples. If these participants subsequently develop invasive cancer, the date of diagnosis and the tumour histology will be reported on the electronic data capture system.\n\nCohort B\u002FC:\n\n• Insufficient tissue, i.e., at least one tissue biopsy unable to be obtained (Fresh Frozen or FFPE)",{"count":308,"type":21},600,"TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pleural mesothelioma.",[311,312,313],"Lung Cancer, Non-small Cell","Small Cell Lung Cancer","Pleural Mesothelioma",{"date":271,"type":34},{"date":316,"type":34},"2023-10-20",{"date":318,"type":21},"2034-06",{"name":40,"class":41},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":54,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100415129","phase-3-brentuximab-vedotin-in-early-stage-hodgkin-lymphoma-100415129","NCT04685616","Brentuximab Vedotin in Early Stage Hodgkin Lymphoma","A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +\u002F- ISRT With A2VD +\u002F- ISRT in Patients With Previously Untreated Stage IA\u002FIIA Hodgkin Lymphoma","RADAR","Inclusion Criteria:\n\n* Males and females aged 16-69 years (inclusive) (age range is 18-69 in US and EU)\n* Histologically confirmed classical Hodgkin lymphoma\n* Stage I or II supradiaphragmatic disease with no mediastinal bulk disease (defined as greater than a third of the transthoracic diameter at any level of thoracic vertebra as determined by CT) or B symptoms. Bulky disease at other sites is acceptable. Extranodal disease (single extranodal site (stage I) or contiguous nodal extension (stage II)) is acceptable.\n* ECOG performance status 0-2.\n* No previous treatment for Hodgkin lymphoma\n* Fit to receive anthracycline-based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of ≥50%)\n* Creatinine clearance (measured or calculated \\>40ml\u002Fmin\n* Total bilirubin \\\u003C1.5 x upper limit of normal, unless attributable to disease or known Gilbert's syndrome\n* ALT or AST \\\u003C 2 x upper limit of normal\n* Adequate bone marrow function with neutrophils ≥1.0x10\\^9\u002Fl and platelets ≥100x10\\^9\u002Fl\n* Haemoglobin ≥8g\u002FdL\n* Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7 days\n* Infradiaphragmatic disease\n* Nodular lymphocyte predominant Hodgkin lymphoma\n* Absence of FDG-avid lesions on baseline PET scan\n* Age 70 years or over or age 15 years or under\n* Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin are not excluded\n* Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis\n* Pre-existing grade ≥1 sensory or motor neuropathy from any cause\n* History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain\n* Symptomatic neurologic disease compromising normal activities of daily living or requiring medications\n* Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive)\n* Any active systemic viral, bacterial or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first trial drug dose\n* Receiving or recently treated with any other investigational agent (within 4 weeks of trial entry)\n* Pregnant or breastfeeding women\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD\n* Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration\n* Other significant medical or psychiatric comorbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous","69 Years",{"count":330,"type":21},1042,[106],"RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel. Trial 1 will be led and sponsored by University College London (UCL) and conducted in Europe and Australia\u002FNew Zealand. Trial 2 will be led by the Canadian Cancer Trials Group (CCTG) and conducted in North America, with CCTG the regulatory sponsor in Canada, and University of Miami the regulatory sponsor and IND holder in the US. Datasets from Trial 1 and Trial 2 will be combined to achieve the total sample size. Data analysis will be performed by UCL and therefore UCL is responsible for the clinicaltrials.gov entry.\n\nEligible patients will be randomised to receive either ABVD or A2VD chemotherapy.\n\nAn interim PET-CT scan will be performed after 2 cycles of treatment, which will be used to adapt subsequent treatment. Patients will receive a total of 3-4 cycles of chemotherapy and may also receive involved site radiotherapy as consolidation.\n\nPatients will be followed up for a minimum of 5 years after treatment.",[334],"Hodgkin Lymphoma",[336,337,338],"PET-response adapted","Stage IA\u002FIIA Hodgkin lymphoma","Brentuximab vedotin","2026-07-06",{"date":341,"type":34},"2026-07-08",{"date":343,"type":34},"2022-04-14",{"date":345,"type":21},"2032-09",{"name":40,"class":41},72,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":101,"minAge":102,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":54,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100642128","prostate-mri-analysis-by-radiologists-and-artificial-intelligence---disease-identification-and-guided-management-100642128","NCT07647445","Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management","A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.","PARADIGM","Inclusion Criteria:\n\n1. Men at least 18 years of age referred with clinical suspicion of prostate cancer\n2. Serum PSA ≤ 20 ng\u002FmL\n3. Fit to undergo all procedures listed in the protocol\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Prior prostate biopsy\n2. Prior prostate MRI on a previous encounter\\*\n3. Prior treatment for prostate cancer\n4. Contraindication to MRI (e.g. claustrophobia, pacemaker)\n5. Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic\u002Fspinal metalwork)\n6. Contraindication to prostate biopsy\n7. Unfit to undergo any procedures listed in protocol\n\n   * An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.",{"count":357,"type":21},500,[160],"Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men.\n\nNormally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists.\n\nThe PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report.\n\nIf there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.",[361],"Prostate CA",[363,364,365,366,367],"MRI","Prostate","Cancer","AI","Artificial Intelligence","2026-06-29",{"date":370,"type":34},"2026-06-30",{"date":372,"type":21},"2026-10",{"date":374,"type":21},"2029-01",{"name":40,"class":41},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":384,"minAge":102,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":54,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":409},"100608545","phase-2-a-clinical-trial-of-extended-high-treatment-dose-antibiotics-in-combination-with-methenamine-hippurate-compared-to-the-standard-of-care-either-prophylactic-low-dose-antibiotic-treatment-or-methenamine-hippurate-in-females-with-chronic-urinary-tract-infection-100608545","NCT07202949","A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection","EAT-UP - Extended Antibiotic Treatment in Chronic UTI Patients; a Phase II Safety and Efficacy Trial","EAT-UP","Inclusion Criteria:\n\n1. A diagnosis of chronic UTI, without structural or functional urinary tract abnormality\\*, defined as daily persistent symptoms affecting storage (urinary frequency, urgency or urge incontinence) and urinary tract pain symptoms (including bladder pain, urethral pain, or dysuria), for at least 3 months prior to the screening visit, with previously associated transient symptomatic improvement to antibiotic treatment for UTI, which in the opinion of the delegated clinician is secondary to chronic urinary tract infection.\n2. A fresh urine microscopy examination showing ≥20 white blood cells\u002Fµl of urine at the screening visit.\n3. Female\\*\\* patients.\n4. Aged ≥18 years.\n5. Screening blood result of eGFR ≥45ml\u002Fmin\u002F1.73m2.\n6. Able and willing to attend trial visits and comply with all study procedures for the duration of the trial.\n7. Able and willing to provide informed consent prior to any study related assessments and\u002For procedures.\n\n   * A structural or functional abnormality may include kidney reflux, current or long-term catheter use, renal transplant, diversion surgery, renal stones, grade 2 or above utero-vaginal prolapse or incomplete bladder emptying.\n\n     * For the purposes of this trial, a female will be defined as an individual assigned female at birth who has a female urinary tract.\n\nExclusion Criteria:\n\n1. Inability to take at least one of the following antibiotics: Cefalexin, Nitrofurantoin, or Trimethoprim, at prophylactic and treatment dose according to NICE guidelines, and\u002For the Summary of Product Characteristics (such as hepatic or renal dysfunction), or any other medical contraindications.\n2. Inability to take methenamine hippurate due to medical contraindications.\n3. Current use of immune-modulating drugs for the treatment of chronic illnesses such as rheumatoid arthritis, chronic lung disease, any other autoimmune conditions or cancer.\n4. Current use of Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors\\*.\n5. A current diagnosis of bladder cancer.\n6. A diagnosis of an active sexually transmitted infection or a recent diagnosis of a sexually transmitted infection within the last 3 months of the screening visit.\n7. Previous use of an antibiotic at treatment dose as per NICE guidelines for more than 14 consecutive days for treatment of UTI in the last 3 months prior to the screening visit.\n8. Pregnancy (or planned pregnancy during trial participation) and\u002For breastfeeding.\n9. Women of childbearing potential that are unable\u002Funwilling to use an acceptable method of contraception (as described in section 3.4.1) to avoid pregnancy for the duration of the trial and for 1 week after the last dose of trial medication.\n10. Current participation in another clinical trial of a device, interventional medicinal product, advanced therapy, or surgical procedure; or previous participation within 6 months of the screening visit.\n11. Any medical condition or previous treatment which in the investigator's opinion compromises the potential participant's ability to participate.\n\n    * Patient's must not have taken a Sodium-Glucose Transport Protein 2 (SGLT2) inhibitor within 24 hours before the screening visits to be eligible for the trial.","FEMALE",{"count":386,"type":21},192,[290],"Chronic Urinary Tract Infection (UTI) is a type of UTI where symptoms are constant and occur every day, unlike recurrent UTIs, which come and go with symptom-free breaks in between. Current treatment for chronic UTI within the NHS is based on recommended guidelines for recurrent UTI. The standard approach typically includes one of the following treatments:\n\n* Long-term, prophylactic (low) dose daily antibiotic (where medication is used at low doses to try to prevent symptoms reoccurring).\n* Long-term use of a urinary antiseptic (which helps keep your urine bacteria free), called methenamine hippurate.\n\nThese often do not work for people with chronic UTI, and symptoms can persist. Moreover, standard urine tests may fail to detect infections, making diagnosis and treatment more challenging.\n\nThe EAT-UP trial will investigate whether longer courses of treatment (higher) dose antibiotics combined with methenamine hippurate (a urinary antiseptic) are a more effective treatment at reducing levels of infection and symptoms than standard of care treatments (as described above).",[390],"Chronic Urinary Tract Infection",[392,393,394,395,396,397,398,399,390,400],"Urinary Tract Infection","Antibiotics","Urological Diseases","methenamine hippurate","Cefalexin","Nitrofurantoin","Trimethoprim","Amoxicillin","UTI","2026-06-19",{"date":403,"type":34},"2026-06-23",{"date":405,"type":34},"2026-02-26",{"date":407,"type":21},"2027-11",{"name":40,"class":41},4,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":54,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":71},"100642211","respiratory-observation-using-ultra-sensitive-nanotechnology-100642211","NCT07650539","Respiratory OBservation Using Ultra-Sensitive nanoTechnology","Respiratory Observation Using Ultra-Sensitive Nanotechnology","ROBUST","Inclusion Criteria:\n\n* Have capacity to consent to the study\n* Undergoing surgery or receiving oxygen therapy\n\nExclusion Criteria:\n\n* Inability to wear the monitor as designed",{"count":419,"type":21},148,[160],"The Problem - About one in three patients get even more sick while they are in hospital. This often happens because of chest infections, sepsis (very serious infection), or heart problems. These illnesses can make it hard to breathe. They are even more dangerous when patients already have breathing problems.\n\nNurses and doctors need to spot when someone is getting worse as early as possible, so they can help them. For example, giving medicines quickly for sepsis can save lives. Sometimes it's hard to tell when someone is getting worse. Sometimes it's noticed too late. This can be very dangerous. In 2023, nearly 8,000 people died because their illness wasn't spotted quickly enough.\n\nEven if patients don't die, they might need longer in hospital and more care. This costs the NHS a lot more money. It also means fewer beds for other patients. Finding better ways to spot these problems early is an important goal.\n\nThe Opportunity - Research shows checking patients more often helps spot problems early. Nurses do many routine checks. These include blood pressure, temperature, heart rate and oxygen levels.\n\nNurses also check the breathing rate (the number of breaths per minute). Breathing rate is the best way to tell if someone is getting sicker. But it is also the hardest to measure properly. The machines we have don't do it well. So, nurses stand by the patient and count how fast they are breathing. This takes time and can be wrong if the patient talks or moves. Sometimes, it's not done at all.\n\nThe Need - Breathing rate is very useful. But we don't have good tools to measure it easily. We need something simple and accurate. It should also be comfortable for patients and fit into normal hospital care.\n\nOur New Idea - RespiraFibre - We've made a new device called RespiraFibre. It's a tiny, smart sensor. It attaches to the oxygen masks or tubes that patients already wear. It can tell how the patient is breathing. If something is wrong, it sends a warning to the nurse or doctor.\n\nIn this project, we will:\n\n1. Work with patients to make sure the RespiraFibre is comfortable.\n2. Make sure hospital staff find it easy to use.\n3. Test how accurate it is.\n4. Try it out on real hospital wards.\n5. Get it ready to use in hospitals across the country.\n\nThe Impact - We want to treat patients fast if they get sick. To do this, we need early warnings if things are getting worse. This will lead to better care, fewer deaths, and lower costs for the NHS. Our work with RespiraFibre will help make this happen.",[423],"Respiratory Monitoring",[425,426,427,428,429],"Nanotechnology sensor","Continuous respiratory monitoring","Clinical deterioration detection","Validation study","Feasibility study","2026-06-10",{"date":432,"type":34},"2026-06-16",{"date":434,"type":21},"2026-08",{"date":436,"type":21},"2029-02",{"name":40,"class":41},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":54,"phases":448,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},"100370650","phase-1-durvalumab-in-combination-with-s-488210s-488211-vaccine-in-non-muscle-invasive-bladder-cancer-100370650","NCT04106115","DURvalumab in Combination With S-488210\u002FS-488211 vAccine in Non-muscle Invasive Bladder CancEr","A Phase Ib\u002FII Study to Assess the Safety and Activity of DURvalumab (MEDI4736) in Combination With S-488210\u002FS-488211 vAccine in Non-muscle Invasive Bladder CancEr","DURANCE","Inclusion Criteria:\n\n1. Histologically proven high risk non-muscle invasive bladder cancer (NMIBC)\n2. Adequate archival tissue sample available for histological assessment (date sample taken must be within 6 months of planned start of treatment)\n3. Predominant histologic component (\\> 50%) must be urothelial (transitional cell) carcinoma\n4. Bacillus Calmette-Guerin (BCG) unresponsive disease or are intolerant of BCG therapy\n5. Refused or deemed clinically inappropriate for radical cystectomy\n6. ≥18 years of age\n7. Body weight \\>30 kg\n8. World Health Organisation (WHO) performance status 0-1\n9. Must have undergone each of the following procedures within 8 weeks of registration:\n\n   * Complete excision of all papillary disease (T1\u002FTaHG) and demonstration of no muscle invasive disease in the resected specimens (muscle must be present in the tumour sample)\n   * Bladder 'Mapping biopsies' taken\n   * CT of the chest\n   * CT Urogram or MRI of the abdomen and pelvis (if CT is not possible)\n10. Adequate haematological status:\n\n    * Haemoglobin ≥9.0 g\u002FdL\n    * Absolute neutrophil count ≥1.5 x 10\\^9\u002FL (≥150,000 per mm3)\n    * Platelet count ≥100 x 10\\^9\u002FL (≥100,000 per mm3)\n    * International Normalised Ratio (INR) ≤1.5 and Activated Partial Thromoplastin Time (APTT) ≤1.5 x Upper Limit Normal (ULN). NB: This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n11. Adequate liver function:\n\n    * Total bilirubin ≤1.5 X ULN (\\\u003C3.0 x ULN for patients with Gilbert's syndrome)\n    * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤2.5 x ULN\n12. Adequate renal function: Measured creatinine clearance ≥40 mL\u002Fmin or calculated creatinine clearance ≥40 mL\u002Fmin using Cockcroft-Gault formula.\n13. Life expectancy of ≥6 months\n14. Willing and able to give informed consent (which includes compliance with the requirements and restrictions listed in the patient information sheet (PIS) and in this protocol). NB: Consent must be obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n15. Patients of child-bearing potential and male patients with female partners of child-bearing potential must agree to use highly effective contraception methods from date of consent, which must be continued for up to 90 days after last treatment administration.\n16. Female patients must not be pregnant. There should be sufficient evidence of post-menopausal status or a negative serum pregnancy test for pre-menopausal female patients.\n17. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and any other study procedures.\n\nExclusion Criteria:\n\n1. Any history of autoimmune or inflammatory disease including (any patients with a history of an autoimmune condition but without active disease in the last 5 years may be included only after consultation with the CI\u002FTMG):\n\n   * Inflammatory bowel disease (e.g. colitis or Crohn's disease)\n   * Diverticulitis (with the exception of diverticulosis)\n   * Systemic lupus erythematous (SLE)\n   * Sarcoidosis syndrome\n   * Wegener syndrome (granulomatosis with polyangitis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, etc.)\n2. Patients with prior allogeneic stem cell or solid organ transplantation\n3. Patients who have had prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)\n4. Active invasive malignancy in the previous 2 years excluding non-melanoma skin cancer\n5. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia) or evidence of active pneumonitis on screening chest CT scan (history of radiation pneumonitis in the radiation field is permitted)\n6. Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n7. QTcF value of \\>470 ms. If prolonged, this should be confirmed by 2 further ECGs each separated by at least 5 minutes.\n8. Patients with the following risk factors for bowel perforation:\n\n   * History of acute diverticulitis or intra-abdominal abcess in the last 3 years\n   * History of mechanical GI obstruction or abdominal carcinomatosis\n9. Any unresolved toxicity CTCAE Grade ≥2 from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with any irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the CI\u002FTMG\n10. Receipt of last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, embolisation, monoclonal antibodies) within 30 days prior to first dose of trial treatment. NB: If sufficient washout time has not occurred due to the schedule or pharmacokinetic (PK) properties of an agent, a longer washout period will be required, as agreed by the Trial Management Group (TMG) and\u002For Chief Investigator (CI).\n11. Treatment with any experimental drug within 30 days or 5 half-lives (whichever is longer) of the first dose of trial treatment\n12. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n13. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial\n14. Received therapeutic oral antibiotics that cannot be discontinued at least 14 days prior to starting treatment or received intravenous (IV) antibiotics within 14 days prior to registration. NB: Patients receiving prophylactic antibiotics (e.g. for prevention of a urinary tract infection or COPD) are eligible\n15. Any psychiatric or other disorder (e.g. brain metastases) that impacts the patients ability to give informed consent or comply with trial treatment and activities\n16. History of leptomeningeal carcinomatosis\n17. Active infection of tuberculosis (TB) (clinically evaluated in accordance with local guidelines, e.g. clinical history, examination and radiographic findings with or without TB testing as clinically indicated)\n18. Patients must not have had systemic corticosteroid therapy (\\>10 mg daily prednisolone equivalent) within 14 days prior to registration or concomitant use of other immunosuppressive medications. NB: The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) are allowed\n19. Administration of a live, attenuated vaccine within 4 weeks prior to planned start of treatment or anticipation that such a live, attenuated vaccine will be required during the study\n20. Evidence of significant uncontrolled concomitant disease that could substantially increase the risk of incurring adverse events (AEs), affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis), uncontrolled hypertension, serious chronic gastrointestinal conditions associated with diarrhoea and uncontrolled major seizure disorder\n21. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of trial treatment. This does not include rigid cystoscopy and biopsies\n22. Significant cardiovascular disease, such as:\n\n    * New York Heart Association cardiac disease (Class II or greater)\n    * Myocardial infarction within 3 months prior to registration\n    * Unstable arrhythmias\n    * Unstable angina\n23. Patients with uncontrolled Type 1 diabetes mellitus. Patients controlled on a stable insulin regimen are eligible\n24. Patients with uncontrolled adrenal insufficiency\n25. Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA\n26. Known active primary immune deficiency, including but not limited to, uncontrolled human immunodeficiency virus (HIV) (detectable viral load) or acquired immunodeficiency syndrome (AIDS)-related illness\n27. Women who are pregnant or breast feeding. Female or male patient of reproductive potential who is not willing to employ highly effective birth control from screening to 90 days after the last dose of trial treatment.\n28. Known allergy or hypersensitivity to any of the investigational products or their excipients\n29. Prior enrolment to, or treatment in a previous durvalumab clinical study, regardless of treatment arm assignment\n30. Patients must not donate blood while participating in this study and for at least 90 days following the last dose of trial treatment",{"count":447,"type":21},52,[56,290],"DURANCE is a two part, phase Ib\u002FII, multi-centre study to assess the safety and activity of S-488210\u002FS-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).",[451],"Bladder Cancer",[453,454,455,456,457,458,459],"Non-Muscle Invasive Bladder Cancer (NMIBC)","Durvalumab","S-488210\u002FS-488211","Immunotherapy","Vaccine","PD-L1 Inhibitor","BCG unresponsive","2026-06-09",{"date":462,"type":34},"2026-06-11",{"date":464,"type":34},"2022-03-25",{"date":466,"type":21},"2032-09-30",{"name":40,"class":41},7,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":54,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":148},"100601593","prism-the-primary-care-individual-social-norms-msk-data-dashboard-a-feasibility-trial-100601593","NCT07112508","PRISM: The PRimary Care Individual Social Norms MSK Data Dashboard: a Feasibility Trial","PRISM: The PRimary Care Individual Social Norms MSK Data Dashboard: a Cluster Randomised Feasibility Trial in Clinician Management of Musculoskeletal Patients.","PRISM","Inclusion and Exclusion Criteria for Sites and Individual FCPs Site Inclusion Criteria\n\n* FCPs (First Contact Physiotherapists) must have regular clinical supervision by a more experienced physiotherapist.\n* Health Care Professionals Council (HCPC) registered Physiotherapists.\n* Provide physiotherapy to NHS patients.\n* Able to send monthly data uploads to the UCL Data Safe Haven to be added to the PRISM dashboard.\n\nPatient Inclusion Criteria\n\n* 18 years of age and above.\n* Registered with a GP practice that is a Participant Identification Centre for this study.\n* Consented to provide outcome measures as part of the trial process.\n\nSite Exclusion Criteria\n\n* No clinical supervision by a more experienced physiotherapist available currently or in practice for the FCPs.\n* Community service physiotherapy.\n* Unable to send data to the UCL Data Safe Haven monthly.\n\nPatient Exclusion Criteria\n\n* Non-musculoskeletal (MSK) problem.\n* Insufficient level of English understanding and expression to allow independent completion of assessment instruments.\n* Lacking capacity or unwilling to consent.\n* Patients who attended FCP but were not treated as they were found to have been an inappropriate referral.",{"count":478,"type":21},60,[160],"Background:\n\n20 million people in UK have musculoskeletal (MSK) aches and pains. They commonly see their GP about this problem, but practices are so busy that it can mean a long wait for appointments. First Contact Practitioner (FCPs) are now working in the GP practices to see patients with MSK problems instead of their GP. A national evaluation has found this to be working well.\n\nFor FCPs working in GP practices there is more clinical risk. The patients have not been previously screened by a doctor to ensure there is no medical cause for their pain. The Chartered Society of Physiotherapists (CSP) has advised that all FCPs be clinicians with the highest level of experience, known as Advanced Practitioners. However the demand for FCPs far outweighs the number of Advanced Practitioners available so physiotherapists being hired have less experience.\n\nEvidence shows that clinicians of different experience levels have different decision-making strategies which may cause unwarranted variation in care. A new method is needed for oversight and support of the FCPs. Clinical supervision is commonly utilised in the NHS and in physiotherapy teams. It is a space to reflect on a clinician's performance and create learning opportunities.\n\nThis research suggests an individual data dashboard, shared only with individuals and their supervisor, that feeds back a clinician's own decision-making data to them, relative to their peers. For example, the participant is \"in the top 20% of MRI requesters\" or \"in the top 20% of those referring to social prescribing\". This type of feedback is known as 'social norms' feedback. It has been proven to be an effective way to change healthcare workers behaviour. The intervention will be called PRISM: Primary Care Individual Social Norms MSK Data Dashboard.\n\nAims To explore the feasibility of a randomised clinical trial comparing the clinical decision-making behaviour of FCP services using the PRISM Dashboard and a usual service with no clinician feedback.\n\nDesign \\& Methods:\n\nThis research is a feasibility trial, a process to assess whether a future full scale clinical trial within the NHS would work. It will take place across 4 different Primary Care commissioning areas to determine the possibility of recruitment, retention, outcome collection and whether people will use the intervention.\n\nPPIE for this research included one primary care PPI rep, one digital interventions PPI rep and 3 Healthwatch PPI reps. Engaging different PPI sources enabled participation from different social , cultural and ethnic backgrounds.\n\nDissemination I will communicate research updates and outputs in conferences, via social media, blogs, newsletters and podcasts. I will use my own network as well as the reach of collaborators in this work, ie. Healthwatch, NHS England\u002FImprovement, The (CSP), the physiotherapy digital network, Keele University and UCL research networks.",[482],"Musculoskeletal Disorders",[484,485,486,487,488,489],"Musculoskeletal","Primary Care","First Contact Physiotherapy","First Contact Practitioner","Digital Health","Behaviour change","2026-06-01",{"date":492,"type":34},"2026-06-04",{"date":494,"type":34},"2026-04-01",{"date":496,"type":21},"2027-11-01",{"name":40,"class":41},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":54,"phases":507,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":71},"100490340","electrical-impedance-tomography--selective-stimulation-of-vagus-nerve-100490340","NCT05664854","Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve","Electrical Impedance Tomography Imaging of Functional Anatomy and Selective Stimulation of Fascicles Within the Vagus Nerve","EITsVNS","Inclusion Criteria:\n\n* Age over 18\n* Written informed consent by patient or proxy\n* Clinical diagnosis of disorder affected directly or indirectly or will possibly respond to vagus nerve stimulation\n\nExclusion Criteria:\n\n* Aged 17 and below\n* Unfortunately, it is unlikely that interpreters of all languages will be available in the unit so persons who cannot understand verbal explanation in English and for whom we could not find a suitable consultee would have to be excluded from the study.",{"count":20,"type":21},[160],"Electroceuticals is a new field in which the goal is to treat a wide variety of medical diseases with electrical stimulation of autonomic nerves. A prime target for intervention is the cervical vagus nerve as it is easily surgically accessible and supplies many organs in the neck, thorax and abdomen. It would be desirable to stimulate selectively in order to avoid the off-target effects that currently occur. This has not been tried in the past, both because of limitations in available technology but also because, surprisingly, the fascicular organisation of the cervical vagus nerve is almost completely unknown. The aim of this research is to investigate the functional anatomy of fascicles in the cervical vagus nerve of humans. This will include defining innervation to the heart, lungs and recurrent laryngeal and, if possible, the oesophagus, stomach, pancreas, liver and gastrointestinal tract. It will be achieved by defining fascicle somatotopic functional anatomy with spatially-selective vagus nerve stimulation (sVNS) and the new method of fast neural imaging with Electrical Impedance Tomography (EIT). EIT is a novel imaging method in which reconstructed tomographic images of resistance changes related to the opening of ion channels over milliseconds can be produced using rings or arrays of external electrodes. In humans, using a nonpenetrating nerve cuff with sVNS or fast neural EIT, this will be performed for 30 minutes transiently during an operation to insert a vagal nerve stimulator for treatment of epilepsy and deliver images in response to activity such as respiration or the electrocardiogram (ECG).",[510,511,512],"Vagus Nerve Diseases","Epilepsy","Vagus Nerve Autonomic Disorder",[514,515,516,517,518],"Electrical Impedance Tomography","Selective Vagus Nerve Stimulation","Vagus Nerve","Electrophysiology","Vagus Nerve Stimulation","2026-05-26",{"date":521,"type":34},"2026-05-27",{"date":523,"type":34},"2023-12-04",{"date":525,"type":21},"2027-07-31",{"name":40,"class":41},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":134,"enrollmentInfo":534,"targetDuration":4,"studyType":54,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":42},"100243169","phase-1-carpall-immunotherapy-with-cd19cd22-car-t-cells-for-cd19-and-cd22-acute-lymphoblastic-leukaemia-100243169","NCT02443831","CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia","Immunotherapy With CD19+CD22 CAR Redirected T-cells for High Risk\u002FRelapsed Paediatric CD19+ and CD22+ Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\n1. Children and young adults (age 24 years or younger) with high risk\u002Frelapsed CD19+ and CD22+ acute lymphoblastic leukaemia with:\n\n   1. Resistant disease (\\>5% blasts) at end of ALLTogether-1 protocol or equivalent induction\n   2. ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD \\>10-4 at week 9 ALLTogether-1 Protocol or equivalent).\n   3. High risk infant ALL (age \\\u003C 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count \\> 300 x 10\\^9\u002FL or poor steroid early response (i.e. circulating blast count \\>1x10\\^9\u002FL following 7 day steroid pre-phase of induction as per national guidelines or equivalent)\n   4. Any patient with t(17,19) TCF3-HLF rearrangement\n   5. High risk 1st relapse (defined as very early (relapse within 18 months of diagnosis) and early relapses (any patient relapsing on therapy or within 6 months of completing treatment) and any relapse with high risk genetics, namely (KMT2A (MLL) rearrangements, low hypodiploidy\u002Fnear haploidy, t(17;19)(q22;p13)\u002FTCF3-HLF, iAMP21 and t(1;19)(q21;p13)\u002FTCF3- PBX1, t(9;22)(34.1 q11.2)\u002FBCR-ABL1\n   6. Any on therapy relapse in patients age 16-24\n   7. Any relapse of infant ALL\n   8. ALL post ≥ 2nd relapse\n   9. Any refractory relapse of ALL (defined as \\> 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)\n   10. ALL with MRD \\>10-4 prior to planned stem cell transplant\n   11. Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant\n   12. Any relapse of ALL after stem cell transplant as long as planned time of CD19+CD22CAR T cell infusion is \\> 4 months post-transplant\n   13. Early (defined as \\\u003C 6 months post-infusion) loss of B cell aplasia or any CD19+CD22+ relapse following CD19CAR T cell therapy with Tisagenlecleucel\n\n   Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study\n2. Agreement to have a pregnancy test, use adequate contraception (if applicable)\n3. Written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria for registration:\n\n1. Active Hepatitis B, C or HIV infection\n2. Oxygen saturation ≤ 90% on air\n3. Bilirubin \\> 3 x upper limit of normal\n4. Creatinine \\> 3 x upper limit of normal\n5. Women who are pregnant or breastfeeding\n6. Stem Cell Transplant patients only: active significant (overall Grade ≥ II, Seattle criteria) acute GVHD or moderate\u002F severe chronic GVHD (NIH consensus criteria) requiring systemic steroids.\n7. Inability to tolerate leucapheresis\n8. Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10) score ≤ 50%\n9. Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy)\n10. CD19 negative or CD22 negative disease\n\nExclusion criteria for CD19+CD22CAR T-cell infusion:\n\n1. Severe intercurrent infection at the time of scheduled CD19+CD22 CAR T-cell infusion\n2. Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19+CD22 CAR T-cell infusion\n3. Allogeneic transplant recipients with active significant acute GVHD overall grade ≥II or moderate\u002Fsevere chronic GVHD requiring systemic steroids at the time of scheduled CD19+CD22 CAR T-cell infusion. Note: Such patients will be excluded until the patient is GVHD free and off steroids",{"count":20,"type":21},[56],"This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia",[538],"Acute Lymphoblastic Leukemia",[540],"high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia","2026-05-18",{"date":543,"type":34},"2026-05-22",{"date":545,"type":34},"2016-04",{"date":547,"type":21},"2041-12-31",{"name":40,"class":41},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":101,"minAge":102,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":560,"conditions":561,"keywords":566,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":71},"100641019","everist-impact-of-image-detected-accessory-pudendal-artery-on-erection-recovery-after-nerve-sparing-prostatectomy-100641019","NCT07597798","EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy","EVERiST: Erectile Function Recovery After Bilateral neuroVascular Bundle Sparing Robot Assisted Radical prostatEctomy in Patients With or Without an Accessory Pudendal aRtery Detected on diagnoSTic Multiparametric MRI: A Feasibility Study","EVERiST","Inclusion Criteria:\n\n* Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic backgrounds.\n* Patients who underwent a prostate mpMRI before prostate biopsy.\n* Medically fit to undergo RARP.\n* Diagnostic quality prostate biopsies concordant with a diagnostic quality prostate mpMRI adequate to provide a surgical plan.\n* Scheduled for RARP with a recommendation of NVB spare based on multidisciplinary meetings informed by mpMRI, biopsy result and clinical factors.\n* Sexually active men with no to mild ED at baseline based on IIEF-EFD (\\>=24) questionnaire.\n* Preference to preserve erectile function for sexual intercourse.\n* Ability to read English sufficiently to understand PIS and able to give informed consent.\n\nExclusion Criteria:\n\n* Established moderate\u002F severe ED (IIEF-EFD \\\u003C24)\n* Patients who received neo-adjuvant androgen deprivation therapy.\n* Patients with previous surgery for benign prostatic enlargement\n* Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.\n* Previous pelvic or penile fracture\n* Previous surgery for ED\n* Poor quality prostate mpMRI or biparametric MRI (no contrast)\n* Established vascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease)","79 Years",{"count":559,"type":21},40,"Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards.\n\nIn this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants.\n\nThe results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.",[562,563,564,565],"Radical Prostatectomy","Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Due to Arterial Insufficiency","Robotic Radical Prostatectomy",[567,568,569,570,571,572],"ED post RARP","Prostate Cancer Survivorship","Erectile dysfunction","Radical prostatectomy","Accessory pudendal artery","APA","2026-05-13",{"date":575,"type":34},"2026-05-19",{"date":577,"type":34},"2026-01-15",{"date":579,"type":21},"2028-01-15",{"name":40,"class":41},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":54,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":71},"100638967","potential-for-recovery-of-voluntary-finger-extension-after-stroke-100638967","NCT07592247","Potential for Recovery of Voluntary Finger Extension After Stroke","PROVES","Inclusion Criteria\n\n* Diagnosed with a Stroke \\>6 months previously\n* Medical Research Council (MRC) grade 0 or 1 in long finger extensors.\n\nExclusion Criteria\n\n* Presence of spasticity in any wrist\u002Ffinger flexors (including lumbricals) \\>2 on Modified Ashworth Scale\n* Unable to get hand flat on table top\n* Botulinum toxin to long finger or wrist flexors \\\u003C 24 weeks prior to pre-treatment assessment (i.e. effects should have worn off).",{"count":589,"type":21},100,[160],"Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. In this study, we will identify the characteristics of those chronic stroke patients who regain previously absent VFE.\n\nHundred chronic stroke patients will be recruited with absent\u002Fnegligible VFE in an external pilot and feasibility study. Transcranial magnetic stimulation will be used to determine the functional integrity of descending white matter pathways. Corticospinal tract integrity to finger extensor muscles will be based on whether motor-evoked potentials are present (MEP+) or absent (MEP-). Reticulospinal tract activity will be assessed by measuring ipsilateral MEP amplitudes and the Start-React response.\n\nAll patients will then receive 3-months of neuromuscular electrical stimulation plus home exercise, designed to strengthen wrist\u002Ffinger extensors, reduce spasticity and increase corticospinal excitability. The primary outcome measure will be restoration of VFE.\n\nIt is predicted that VFE will be restored in MEP+ but not MEP- patients. MEP- patients will have higher reticulospinal tract activity associated with spasticity. Restoration of VFE will allow patients to engage in evidence-based upper limb training to improve function e.g. constraint induced movement therapy or repetitive task training.",[593],"Stroke",[595,596,597,598,599,600],"Upper limb","Finger extension","Neurophysiological mechanisms","Neurorehabilitation","Motor recovery","functional electrical stimulation",{"date":541,"type":34},{"date":603,"type":21},"2026-09-01",{"date":605,"type":21},"2029-09-01",{"name":40,"class":41},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":101,"minAge":102,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":54,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":71},"100634609","a-study-to-evaluate-the-performance-of-confocal-microscopy-to-detect-positive-margins-during-radical-prostatectomy-100634609","NCT07541911","A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy","A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy","LaserSAFE","Inclusion Criteria:\n\n* Patients diagnosed with clinically significant operable cT2-T3a N0 M0 PC.\n* Medically fit to undergo RARP.\n* Scheduled for robot-assisted RARP with a recommendation against intrafascial nerve sparing on at least 1 side based on multidisciplinary meetings informed by MRI, biopsy result and clinical factors.\n* Ability to read English sufficiently to understand PIS and able to give informed consent.\n\nExclusion Criteria:\n\n* Patients who received neo-adjuvant ADT.\n* MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score or tumour away from the posterolateral areas of the prostate)\n* MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or bulging tumour on MRI T2 images)\n* Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is deemed not feasible due to oncological safety concerns.\n* Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.",{"count":616,"type":21},693,[160],"The goal of this study is to find out whether a new method called \"LaserSAFE\" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery.\n\nThe main questions it aims to answer are:\n\nCan LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves?\n\nResearchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice.\n\nParticipants will:\n\nComplete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and 12 months after surgery",[109,620],"Prostate Cancer (Adenocarcinoma)",[622,623,624,113],"Confocal microscopy","Prostatectomy","Positive margins",{"date":541,"type":34},{"date":627,"type":34},"2026-04-20",{"date":629,"type":21},"2031-05-20",{"name":40,"class":41},{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":640,"conditions":641,"keywords":644,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":656,"locationsCount":71},"100607757","health-impact-of-non-tuberculous-mycobacteria-pulmonary-disease-ntm-pd-100607757","NCT07192705","Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)","An Observational Cross-sectional Study Exploring Differences in Health Between People With Non-Tuberculous Mycobacteria Pulmonary Disease and People With Bronchiectasis Without NTM Pulmonary Infection.","Inclusion Criteria:\n\n\\- Age: 18 years or older, able to provide informed consent.\n\nNTM-PD Group:\n\n* Participants will be adults diagnosed with confirmed NTM-PD based on the British Thoracic Society (BTS) guidelines.\n* The participant should not be on any antimicrobial therapy (at least two weeks before participation) and should not have previously received or be currently on antimicrobial therapy for NTM-PD.\n\n  \\* BTS guidelines:\n* Clinical (both required):\n* Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or a high-resolution CT scan that shows multifocal bronchiectasis with multiple small nodules.\n* Appropriate exclusion of other diagnoses.\n* Microbiological:\n* A minimum of two positive expectorated sputum culture results of the same NTM species from samples collected on separate days within 12 months before recruitment.\n\nOR\n\n* Positive culture results from at least one bronchial wash or lavage. OR\n* Transbronchial or other lung biopsy with mycobacterial histopathological features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathological features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture-positive for NTM.\n\nBronchiectasis Group:\n\n* Diagnosed with bronchiectasis, as confirmed in medical records based on clinical assessment, and radiological findings.\n* Never had a history of positive culture result for NTM pulmonary infection.\n* The latest NTM-negative result must be within the past 12 months from the study's start date or no earlier than 2024.\n\nExclusion Criteria:\n\n\\- Age: Under 18 years of age, or unable to provide informed consent.\n\nNTM-PD Group:\n\n* No confirmation of NTM-PD diagnosis.\n* Diagnosed with a reinfection of NTM-PD.\n* Started antimicrobial therapy for NTM-PD.\n\nBronchiectasis Group:\n\n* No diagnosis of bronchiectasis or diagnosis of bronchiectasis with NTM-PD.\n* Diagnosed with other chronic respiratory diseases considered primary conditions, rather than bronchiectasis.\n* Participants with a history of NTM pulmonary infection.\n* NTM-negative results obtained before 2024.",{"count":639,"type":21},80,"Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail.\n\nNon-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone.\n\nThe investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease.\n\nThe research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle\u002Ffat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months.\n\nThe results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.",[642,643],"Non-Tuberculous Mycobacteria Pulmonary Disease","Bronchiectasis",[642,645,646,647,643,648,649,650],"NTM-PD","Non-Tuberculous Mycobacteria Lung Disease","Health Impact of NTM-PD","NTM-LD","Bronchiectasis without NTM-PD","Non-Pharmacological Intervention",{"date":652,"type":34},"2026-05-14",{"date":654,"type":34},"2025-08-14",{"date":490,"type":21},{"name":40,"class":41},{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":664,"sex":17,"minAge":665,"maxAge":102,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":4},"100637956","detection-of-scoliosis-100637956","NCT07581015","Detection of Scoliosis","Early Detection of Adolescent Idiopathic Scoliosis Using Machine Learning on Plantar Pressure Data","Inclusion Criteria:\n\n* Healthy Controls: Adolescents without any spinal condition or significant musculoskeletal issues, and with no prior history of scoliosis, to provide normal plantar pressure data for comparison.\n* Scoliosis Diagnosis: Adolescents diagnosed with adolescent idiopathic scoliosis (AIS) by a healthcare professional (through clinical evaluation and\u002For radiographic assessment) are eligible.\n* Age: Participants must be between the ages of 10 and 18 years at the time of recruitment.\n* Willingness to Participate: Participants and their parent(s)\u002Fguardian(s) must provide informed consent\u002Fassent prior to participation.\n* Ability to Complete Study Procedures: Participants must be able to complete the plantar pressure measurement test, which requires standing on a pressure mat for a few minutes.\n\nExclusion Criteria\n\n* Severe Pain or Discomfort: Participants unable to stand or walk comfortably due to pain or musculoskeletal issues.\n* Non-cooperation: Participants who are unable or unwilling to follow instructions or consent\u002Fassent procedures.\n* Uncontrolled Medical Conditions: Adolescents with uncontrolled conditions (e.g., cardiovascular or endocrine disorders) compromising participation.\n* Recent Foot Injuries or Conditions: Participants with foot injuries or conditions (e.g., wounds, infections) that may interfere with plantar pressure measurement.",true,"10 Years",{"count":357,"type":21},"This study aims to evaluate whether plantar pressure data collected during standing and walking can be used with machine learning to support early detection of scoliosis in young people. Patients with scoliosis and healthy volunteers aged 10-18 will undergo a short assessment using a pressure mat.",[669],"Adolescent Idiopathic Scoliosis (AIS)","2026-05-05",{"date":672,"type":34},"2026-05-12",{"date":674,"type":21},"2026-06",{"date":676,"type":21},"2028-07",{"name":40,"class":41},""]