[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Birmingham\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":701},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,45,80,124,146,169,192,224,259,291,313,340,368,400,425,447,477,503,527,548,584,609,632,655,679],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":7},"100504472","phase-2-relapsed-follicular-lymphoma-randomised-trial-against-standard-chemotherapy-100504472",false,"NCT05848765","Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy","Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms","REFRACT","Inclusion Criteria:\n\n1. Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry)\n2. Aged 18 years or over\n3. Advanced disease that in the opinion of the treating physician requires treatment\n4. Patient suitable for standard available therapy at the Investigator's discretion\n5. Prior therapy with at least one line of immunochemotherapy. Previous radiotherapy at any time is permitted and will not count as a line of therapy. Previous rituximab monotherapy is also permitted as long as patients have at any time also received at least one line of immunochemotherapy\n6. Assessable disease by PET-CT (at least one involved node with long diameter \\>1.5cm, or extranodal lesion \\>1cm )\n7. ECOG performance status of 0, 1 or 2 at trial entry\n8. Adequate organ function defined as; i. ANC ≥ 1.0 x 109\u002FL (growth factor use is permitted) ii. Platelet count ≥ 75 x 109\u002FL, or ≥ 50 x 109\u002FL if bone marrow infiltration or splenomegaly iii. ALT and AST level ≤3 x ULN iv. Direct bilirubin level ≤ 2 x ULN, unless due to Gilbert's syndrome v. CrCl ≥ 50mL\u002Fmin (by Cockcroft-Gault formula) vi. PT, INR and aPTT ≤ 1.5 x ULN, unless receiving anticoagulation vii. LVEF within normal limits by MUGA or echocardiography\n9. Able to provide written informed consent\n10. Women of childbearing potential (or their partners) must use an effective form of contraception\n\nExclusion Criteria:\n\n1. Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients with historical high-grade transformation over 1 year ago are eligible)\n2. Non-Fluorodeoxyglucose (FDG) avid disease\n3. Prior allogenic stem cell transplantation (SCT) or solid organ transplant\n4. Prior treatment with lenalidomide\n5. Treatment with CAR-T therapy within 100 days of starting trial treatment\n6. SCT or maintenance therapy planned within 24 weeks of starting treatment (patients planning SCT\u002Fmaintenance after at least 24 weeks of treatment are eligible)\n7. Immunochemotherapy with a platinum-containing regimen planned\n8. Known serological positivity for HIV or uncontrolled HCV\n9. Hepatitis B surface antigen (HBsAg) positive and\u002For detectable viral DNA. Patients positive for Hepatitis B core antibody (anti-HBc) but viral DNA negative are eligible\n10. Other malignancy within 2 years of enrolment, excepting cervical carcinoma stage 1B or less, non-invasive basal cell or squamous cell skin carcinoma, non-invasive, superficial bladder cancer, prostate cancer with a current PSA level \\\u003C0.1ng\u002FmL, any curable cancer with a CR of \\> 2 years duration\n11. Active systemic infection requiring treatment\n12. Current or prior CNS involvement with lymphoma\n13. History of allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy\n14. Known hypersensitivity to any of the experimental arm IMPs. Patients with a known hypersensitivity to a control arm regimen may still be eligible if they have no hypersensitivity to other potential control arm IMPs.\n15. Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n16. Recent cancer treatment (chemotherapy, immunotherapy, biological therapy) within 4 weeks of starting trial treatment; systemic steroid treatment (prednisolone \\> 10mg daily (or equivalent)) within 7 days of cycle 1 day 1 dosing\n17. Unwilling to use appropriate contraception methods whilst on study treatment and for 12 months following end of treatment (or 18 months for female patients whose ICT regimen contains obinutuzumab)\n18. Women who are pregnant or breastfeeding\n19. Prior treatment with the experimental therapy under investigation\n20. Major surgery within 30 days of starting treatment\n21. Severe arrhythmias, heart failure, previous myocardial infarction, acute inflammatory heart disease for ICT regimen containing doxorubicin, or severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease for ICT regimen containing rituximab","ALL","18 Years",{"count":21,"type":22},284,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.",[28,29],"Relapsed Follicular Lymphoma","Refractory Follicular Lymphoma",[31,32],"Epcoritamab","Lymphoma","RECRUITING","2026-04-29",{"date":36,"type":37},"2026-05-05","ACTUAL",{"date":39,"type":37},"2023-09-04",{"date":41,"type":22},"2031-11-30",{"name":43,"class":44},"University of Birmingham","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100487639","phase-2-aristocrat-blinded-trial-of-temozolomide---cannabinoids-100487639","NCT05629702","ARISTOCRAT: Blinded Trial of Temozolomide +\u002F- Cannabinoids","A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma","ARISTOCRAT","Inclusion Criteria:\n\n* Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required).\n* First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.\n* Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e. 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant TMZ.\n\n  * A minimum of 3 cycles of adjuvant TMZ must have been received.\n  * A minimum of Stable Disease (SD) (or Partial Response (PR)\u002FComplete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria).\n* ≥3 months since day 28 of the last cycle of TMZ.\n* Karnofsky Performance Status ≥60.\n* Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n  * Platelet count ≥100 x 109\u002FL\n  * Serum creatinine clearance (measured or calculated (using local standard practice)) \\>30ml\u002Fmin\n  * Total serum bilirubin ≤1.5 x upper limit of normal (ULN)\n  * Liver transaminases \\\u003C2.5 x ULN\n* If surgery has been performed for first recurrence, then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow up deemed suitable for systemic treatment.\n* Recovered from previous treatment side-effects ≤ Grade 2.\n* If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids.\n* Willing and able to provide trial-specific informed consent.\n* Willing and able to comply with trial requirements.\n* Age ≥16.\n* Able to start treatment within 28 days of randomisation.\n\nExclusion Criteria:\n\n* Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).\n* Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.\n* Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.\n* Prior treatment, apart from debulking surgery, for first recurrence of GBM.\n* Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.\n* Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.\n* Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.\n* Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and\u002For unwilling to abstain for the duration of the trial.\n* Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment.\n\n  o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation.\n* Men who are sexually active and unwilling\u002Funable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.\n* Contra-indication to MRI or gadolinium.\n* Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n* Known hypersensitivity to cannabinoids or excipients of the IMP.\n* Known history of current or prior alcohol or drug dependence.\n* Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.\n* Has received a live vaccine within 28 days prior to randomisation.\n* Unable to administer oromucosal medication due to mucosal lesions or other issues.\n* Participation in another therapeutic clinical trial whilst taking part in this trial.\n* Any psychological, familial, sociological or geographical condition hampering protocol compliance.","16 Years",{"count":55,"type":22},120,[25],"ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).",[59,60,61,62],"Glioblastoma","Brain Tumor","Cannabis","Brain Tumor, Recurrent",[64,65,66,67,68,69,70,71,72],"cannabinoid","GBM","temozolomide","sativex","nabiximols","cannabis","glioblastoma","brain","recurrent",{"date":36,"type":37},{"date":75,"type":37},"2023-02-03",{"date":77,"type":22},"2027-04",{"name":43,"class":44},22,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":103,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100430719","phase-2-methods-of-t-cell-depletion-trial-motd-100430719","NCT04888741","Methods of T Cell Depletion Trial (MoTD)","A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide","MoTD","Inclusion Criteria:\n\n* Availability of suitably matched unrelated donor (9\u002F10 or 10\u002F10)\n* Planned to receive one of the following RIC protocols:\n\n  * Fludarabine-Melphalan (Fludarabine 120-180mg\u002Fm2 IV; melphalan ≤ 150mg\u002Fm2 IV)\n  * BEAM or LEAM (carmustine 300mg\u002Fm2 IV or lomustine 200mg\u002Fm2 IV with: etoposide 800 mg\u002Fm2 IV; cytarabine 1600mg\u002Fm2 IV; melphalan 140mg\u002Fm2 IV)\n  * Fludarabine-Busulphan (Fludarabine 120-180mg\u002Fm2 IV; Busulphan ≤ 8mg\u002Fkg PO or 6.4mg\u002Fkg IV)\n  * Fludarabine- Treosulfan (Fludarabine 150mg\u002Fm2 IV; Treosulfan 30g\u002Fm2 IV)\n* Planned use of PBSCs for transplantation\n* Planned allo-SCT for one of the following haematological malignancies:\n\n  * AML in CR (patients enrolled onto the COSI trial are not eligible for this study)\n  * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)\n  * CMML \\\u003C10% blasts\n  * MDS \\\u003C10% blasts (patients enrolled onto the COSI trial are not eligible for this study)\n  * NHL in CR\u002FPR\n  * HL in CR\u002FPR\n  * MM in CR\u002FPR\n  * CLL in CR\u002FPR\n  * CML in 1st or 2nd chronic phase\n  * Myelofibrosis\n* Age 16-70 years\n* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nExclusion Criteria:\n\n* Use of any method of graft manipulation (excluding storage of future DLI)\n* Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined\n* Known hypersensitivity to study drugs or history of hypersensitivity to rabbits\n* Pregnant or lactating women\n* Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period\n* Life expectancy \\\u003C8 weeks\n* Active HBV or HCV infection\n* Organ dysfunction defined as:\n\n  * LVEF \\\u003C45%\n  * GFR \\\u003C50ml\u002Fmin\n  * Bilirubin \\>50µmol\u002Fl\n  * AST\u002FALT\\>3 x ULN\n* Participation in COSI or ALL-RIC trials\n* Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.\n* Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.","70 Years",{"count":90,"type":22},400,[25],"A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.",[94,95,96,97,98,99,100,101,102],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndromes","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Multiple Myeloma","Chronic Myelogenous Leukemia","Myelofibrosis",[104,105,106,107,108,109,110,111,112,113,114,115,116],"GvHD","Allogeneic Stem Cell Transplant","AML","MDS","CML","CMML","NHL","HL","Cyclophosphamide","Thymoglobulin","Cyclosporin","Sirolimus","Mycophenolate Mofetil",{"date":36,"type":37},{"date":119,"type":37},"2021-02-22",{"date":121,"type":22},"2027-08-23",{"name":43,"class":44},17,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":132,"targetDuration":134,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100383563","tessa-jowell-brain-matrix---platform-study-100383563","NCT04274283","Tessa Jowell BRAIN MATRIX - Platform Study","A British Feasibility Study of Molecular Stratification and Targeted Therapy to Optimize the Clinical Management of Patients With Glioma by Enhancing Clinical Outcomes, Reducing Avoidable Toxicity, Improving Management of Post-operative Residual & Recurrent Disease and Improving Survivorship","BRAIN MATRIX","Inclusion Criteria:\n\n* Newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample.\n* Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis).\n* Valid written informed consent for the study.\n\nExclusion Criteria:\n\n* Primary spinal cord tumours\n* Active treatment of other malignancy\n* Contraindication to MRI\n* Patients without standard of care imaging available",{"count":133,"type":22},1000,"5 Years","OBSERVATIONAL","The main aim of the Tessa Jowell BRAIN MATRIX - Platform Study is to more precisely determine the exact type of tumour patients have by developing the essential infrastructure to provide rapid and accurate molecular diagnosis. A large network of clinical hubs across the United Kingdom, with expertise in managing patients with brain tumours, will be developed. Once established this infrastructure will facilitate the rapid introduction of clinical trials testing targeted therapies tailored to the genetic changes of an individual's tumour.",[138],"Glioma",{"date":36,"type":37},{"date":141,"type":37},"2020-11-24",{"date":143,"type":22},"2028-02",{"name":43,"class":44},14,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100538121","phase-2-faecal-microbiota-transplantation-in-primary-sclerosing-cholangitis-100538121","NCT06286709","FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Participants must be able to understand and comply with the purpose and procedures that are involved in the trial\n4. An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care\n5. An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)\n6. A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)\n7. Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:\n\n   1. Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%\n   2. Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage \\\u003CIV (or equivalent) in the last 24 months\n   3. Serum enhanced liver fibrosis score (ELF) ≤9.8\n8. A colonoscopy showing no evidence of dysplasia\u002Fneoplasia within 24 months before screening\n9. No evidence of active colitis, as evidenced by a Partial Mayo Score of ≤4, with a score of \\\u003C2 on the rectal bleeding domain at screening\n10. Individuals with IBD who are receiving treatment with biologics, immunosuppression or corticosteroids must be taking a stable dose for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial\n11. Individuals with PSC having overlapping features of autoimmune hepatitis may be included, provided:\n\n    1. The dosage of immunosuppression has remained stable for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial; and\n    2. There is evidence of concomitant colitis\n\nExclusion Criteria:\n\n1. Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection\n2. Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer\n3. Presence of a clinically significant dominant stricture based on the combination of radiological, biochemical and clinical features. Patients can be included in the trial with a dominant extrahepatic stenosis if it has been stable for 6 months or more (as evidenced on imaging and also clinically), and one of the following are satisfied:\n\n   1. The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR\n   2. The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability\u002Fpatient choice\n4. Presence of a percutaneous drain or bile duct stent\n5. Evidence of hepatic decompensation within twelve weeks prior to screening; or concern by the Principal Investigator that the participant may decompensate during the trial period. Hepatic decompensation as evidenced by variceal haemorrhage, ascites, hepatic hydrothorax, or hepatic encephalopathy (Appendix 1)\n6. Biochemical\u002Flaboratory evidence of very advanced hepatic dysfunction, as evidenced by a serum bilirubin value \\>55 µmol\u002FL (unless Gilbert Syndrome or another condition associated with unconjugated hyperbilirubinaemia, including but not limited to, spherocytosis and disorders of bilirubin conjugation where a bilirubin value\\>45 µmol\u002FL is allowable), serum albumin \\\u003C32 g\u002FL, platelet level of \\\u003C140x109\u002FL, Child-Turcotte-Pugh (CTP) score \\>B7, or a MELD score \\>15\n7. Ascending cholangitis as assessed clinically within twelve weeks of screening\n8. Use of antibiotics within twelve weeks of screening\n9. Participant already listed for liver transplantation, or concerns (investigator discretion) that they may need to be listed for liver transplantation during the trial period\n10. Small duct PSC\n11. Advanced-stage liver fibrosis, as evidenced by a VCTE score \\>14.4kPa, a liver biopsy showing \\>Ishak stage III fibrosis (or equivalent)\n12. Significant renal dysfunction as evidenced by an estimated glomerular filtration rate of \\\u003C60 ml\u002Fmin according to the Cockcroft-Gault formula, or need for dialysis\n13. Human Immunodeficiency Virus (HIV) infection\n14. A symptomatic positive test result for Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the four weeks prior to screening\n15. History of malignancy within the past three years, or ongoing malignancy, other than non-melanomatous skin cancer, or treated cervical carcinoma in situ\n16. Any history of small bowel or colonic resection, or likelihood of resection during the trial period. Individuals with a sub-total colectomy and ileal pouch anal anastomosis are permitted to participate.\n17. Patients who are pregnant or breastfeeding\n18. Women of childbearing potential (see Appendix 2 for definition) who confirm they are not willing to practise effective contraception (see Appendix 3 for further details) for the duration of the trial and for four weeks after the last dose of trial drug. Women who are taking hormonal contraception must confirm stable formulation and dosage for at least 6 weeks prior to treatment\n19. Alcohol consumption \\>21 units per week for men, and \\>14 units per week for women.\n20. Positive urine drug screen at screening\n21. Positive stool test for Clostridioides Difficile toxin or microscopy\u002Fculture positivity for enteric infection within twelve weeks prior to screening\n22. Participation in an interventional trial, or use of a non-licensed investigational agent for any indication within twelve weeks before screening, or five half-lives of the investigational drug, whichever is longer\n23. Newly introduced or a change in dosage of any of the following medications within twelve weeks of screening: fibric acid derivatives, farnesoid X-receptor agonists, anti-gastrointestinal motility agents (e.g., loperamide or opioids), bile acid sequestrants (e.g. colestyramine) or ursodeoxycholic acid (UDCA)\n24. Use of any of the following medications within twelve weeks of screening: oral or intravenous antibiotics, including (but not limited to) vancomycin, rifaximin, rifampicin and metronidazole; probiotic or prebiotic preparations, including (but not limited to) VSL#3 and Symprove",{"count":155,"type":22},58,[25],"FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.",[159,160],"Primary Sclerosing Cholangitis","Inflammatory Bowel Diseases","2026-04-28",{"date":34,"type":37},{"date":164,"type":37},"2024-03-27",{"date":166,"type":22},"2027-02-28",{"name":43,"class":44},5,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100371448","phase-3-mithridate-ruxolitinib-versus-hydroxycarbamide-or-interferon-as-first-line-therapy-in-high-risk-polycythemia-vera-100371448","NCT04116502","MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera","A Phase III, Randomised, Open-label, Multicenter International Trial Comparing Ruxolitinib With Either HydRoxycarbamIDe or Interferon Alpha as First Line ThErapy for High Risk Polycythemia Vera","MITHRIDATE","Population:\n\nHigh risk PV defined as WBC \\>11 x 10\\^9\u002Fl\\* AND at least ONE of the following\n\n* Age \\>60 years\n* Prior thrombosis or haemorrhage\n* Platelet count \\>1000 x 10\\^9\u002Fl\\*\n* Hypertension or diabetes requiring pharmacological therapy (\\*At any time since diagnosis)\n\nInclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Diagnosis of PV meeting the WHO criteria within the past 15 years\n3. Meets criteria of high risk\\* PV (see above for specific population)\n4. Patients must have a screening haemoglobin of \\>8g\u002Fdl\n5. Patients may have received antiplatelet agents and venesection\n6. Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)\n7. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of PV \\> 15 years previously\n2. Absence of JAK-2 mutation\n3. Patients with any contraindications to any of the investigational medical products\n4. Treatment with \\>1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance\u002Fintolerance to that therapy\n5. Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, Tuberculosis\n6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry)\n7. Patients with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption\n8. Patients with uncontrolled neuropsychiatric disorders\n9. Patients with uncontrolled cutaneous cancers\n10. Patients and partners not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication\n11. ECOG Performance Status Score ≥ 3\n12. Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease \\> NYHA ( New York Heart Association) Class II\n13. Patients who have transformed to myelofibrosis\n14. Previous treatment with ruxolitinib\n15. Previous (within the last 12 months) or current platelet count \\\u003C100 x 109\u002FL or neutrophil count \\\u003C 1 x 109\u002FL not due to therapy\n16. Inadequate liver function as defined by ALT\u002FAST \\>2.0 x ULN\n17. Inadequate renal function as defined by eGFR \\\u003C 30 mls\u002Fmin\n18. Unable to give informed consent\n\n    Additional Exclusion Criteria for France Only\n19. All women of childbearing potential (as per Appendix 8 definition)\n20. No affiliation with the French healthcare system\n21. Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up\n22. Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)\n23. Patients deprived of their liberty by a judicial or administrative decision",{"count":178,"type":22},586,[180],"PHASE3","The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.",[183],"Polycythemia Vera","2026-04-27",{"date":161,"type":37},{"date":187,"type":37},"2019-10-25",{"date":189,"type":22},"2030-04-01",{"name":43,"class":44},47,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":200,"sex":18,"minAge":134,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100627248","tetanus-antibody-detection-in-saliva-study-100627248","NCT07446166","TETANUS Antibody Detection in Saliva Study","Development of Novel Diagnostics That Use Point-of-care Lateral Flow Testing Technology for Non-invasive, Individual Assessment of Antibody Protection to Tetanus and Vaccine Need","TETANUS","Inclusion Criteria:\n\n* Able and willing to provide informed consent to take part in the study; either directly or from a parent\u002Fguardian, where appropriate\n* \\[Group A\\] Aged 5-10 years inclusive, and determined as healthy by a member of the study team\n* \\[Group B\\] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team\n* \\[Group C\\] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample\n* \\[Group D\\] Adults aged 18-45 years with one or more of the medical conditions that may affect antibody response to vaccination.\n\nExclusion Criteria:\n\n* Participants or parents\u002Fguardians unwilling or unable to provide informed consent to take part\n* Unwilling or unable to comply with study procedures\n* Have a bleeding disorder deemed significant by study doctor\n* \\[Groups A, B and C only\\] Any health condition which, in the opinion of a study physician which could\n\n  1. mean blood sampling has the potential for harm and\u002For\n  2. affect immune response to a vaccine for example known\u002Fsuspected impairment of immune function (with the exception of Group D)",true,"45 Years",{"count":203,"type":22},390,[205],"NA","This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or has not immunity to tetanus within 10-15mins. If successful, this approach would not require blood sampling or laboratory facilities, empower personalised decision making on vaccine needs and support the development of population level data-driven public health policies.",[208],"Tetanus",[210,211,212,213],"point-of-care","Lateral Flow Test","Rapid Diagnostic","Immune Diagnostic","NOT_YET_RECRUITING","2026-02-25",{"date":217,"type":37},"2026-03-03",{"date":219,"type":22},"2026-02-01",{"date":221,"type":22},"2028-02-01",{"name":43,"class":44},1,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100626795","iih-intervention-a-clinical-trial-comparing-2-treatments-shunts-and-stents-evaluation-of-clinical-effectiveness-and-cost-effectiveness-100626795","NCT07440277","IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness","Intervention To Preserve Vision In Idiopathic Intracranial Hypertension: Evaluation Of Clinical Effectiveness And Cost Effectiveness (IIH Intervention)","Intervention","Inclusion Criteria:\n\n1. Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss.\n2. Presence of papilloedema (Frisén grade ≥ 3) in at least one eye\n3. Age 18 to \\\u003C 64 years at the time of consent.\n4. Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS.\n5. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV\n2. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.\n3. Previous bariatric surgery within the last 3 months\n4. Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.\n5. Patient is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence, in the opinion of the investigator.\n6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n7. Have participated in any other interventional study within 30 days prior to the screening visit (of note participation in the IIH Life database or other observational studies will not prevent enrolment to this study).\n8. Previous randomisation for treatment in the present study.\n9. Pregnant.\n10. Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting.\n11. Secondary causes of raised intracranial pressure. (Refer to Protocol appendix 3 for additional information.)\n12. History of significant documented iodine-based contrast allergy.\n13. History of documented allergy to nitinol or nickel.\n14. Absolute or serious contraindication for general anaesthesia.\n15. Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia).\n16. Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism.\n17. Documented prior non-traumatic intracranial haemorrhage.\n18. History of deep vein thrombosis or pulmonary embolism (within the last 24 months).\n19. History of severe carotid atherosclerotic disease.\n20. History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk.\n21. Presence of intracranial vascular malformation considered clinically symptomatic (current or within 24 months).\n22. Anatomical anomaly of the venous sinus which would prevent safe catheterisation and stenting (e.g. multi-channel sinus).","63 Years",{"count":234,"type":22},80,[205],"Background and study aims Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective.\n\nWho can participate? Adults with a diagnosis of IIH at risk of permanent sight loss\n\nWhat does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data).\n\nWhat are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and\u002For feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual.\n\nWhere is the study run from? University of Birmingham (UK)\n\nWhen is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028\n\nWho is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK)\n\nWho is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)",[238],"IIH - Idiopathic Intracranial Hypertension",[240,241,242,243,244,245,246,247,248,249],"DVSS","dural venous sinus stent","stent","shunt","intracranial pressure","stenosis","papilloedema","visual loss","OCT","RNFL","2026-02-23",{"date":252,"type":37},"2026-02-27",{"date":254,"type":37},"2023-07-18",{"date":256,"type":22},"2028-05-28",{"name":43,"class":44},15,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":266,"minAge":19,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":223},"100611882","feasibility-and-efficacy-of-gtep-for-birth-trauma-100611882","NCT07246356","Feasibility and Efficacy of GTEP for Birth Trauma","A Study to Explore the Feasibility and Efficacy of Group Traumatic Episode Protocol (GTEP) for Reducing Trauma Symptoms Following a Traumatic Birthing Experience","Inclusion Criteria:\n\n* Aged between 18-65 years.\n* Currently under the Black Country Perinatal Mental Health Service\n* Experiencing self-reported trauma symptoms related to a birthing experience within the last 18 months (this includes the birth itself, the postnatal hospital stay, and\u002For any neonatal admissions).\n* Access to technology (e.g., laptop, internet connection) to be able to access the online group.\n* Access to a confidential space within their home, and childcare for their baby\u002Fany other existing children.\n* Proficient levels of English Language to engage with the group.\n* Ability to engage in group therapy based on clinical presentation.\n* Capacity to consent to engage in the GTEP group and research study.\n\nExclusion Criteria:\n\n* Women\u002Fbirthing people whose baby is no longer under their care.\n* Severe and enduring mental health presentations (i.e., diagnosis of bipolar, psychosis and\u002For schizophrenia.\n* Significant sensory impairment (e.g., needing a British Sign Language interpreter).","FEMALE","65 Years",{"count":269,"type":22},10,[205],"This clinical study aims to evaluate the feasibility and initial efficacy of Group Traumatic Episode Protocol (GTEP) for reducing trauma symptoms (measured by the PCL-5 and City BiTS) for individuals following a traumatic birthing experience. A secondary aim is to evaluate the efficacy of GTEP in improving parental wellbeing (measured through the CORE-10) and parent-infant bonding (measured through the PBQ) following a traumatic birthing experience.\n\nParticipants (those who have experienced a traumatic birthing experience) will complete the GTEP intervention, delivered online. They will be asked to complete outcome measures and give feedback on their experience of the group.",[273,274,275],"PTSD (Childbirth-Related)","Psychological Wellbeing","Bonding",[277,278,279,280,281,282],"GTEP","Group EMDR","Birth trauma","Psychological wellbeing","Perinatal","Parent infant bonding","2026-02-18",{"date":285,"type":37},"2026-02-19",{"date":287,"type":37},"2025-06-19",{"date":289,"type":22},"2026-06-30",{"name":43,"class":44},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100515429","phase-2-a-global-study-of-novel-agents-in-paediatric-and-adolescent-relapsed-and-refractory-b-cell-non-hodgkin-lymphoma-100515429","NCT05991388","A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma","Glo-BNHL","Inclusion criteria applicable to all treatment arms:\n\n* Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma\u002FLeukaemia or atypical Burkitt\u002FBurkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL\u002FNot Otherwise Specified (NOS)) at initial diagnosis\n* Radiologically and\u002For histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy) or refractory(\\*) B-NHL. (Note: relapses following prior targeted therapy must have continuing target positivity, confirmed by an established method).\n* If relapse occurs more than two years after previous therapy, a biopsy must be performed\n* Evaluable disease as per the international paediatric non-Hodgkin Lymphoma response criteria, including:\n\n  * at least one bi-dimensionally measurable nodal lesion \\>1.5 cm in its longest dimension;\n  * or at least one bi-dimensionally measurable extra-nodal lesion \\>1.0 cm in its longest dimension on computerised tomography (CT) or Magnetic Resonance Imaging (MRI);\n  * or bone marrow involvement (≥25% involvement from bone marrow, if only site of disease. Any standard method of assessment is acceptable i.e. cytomorphology, flow cytometry and\u002For immunohistochemistry);\n  * or, dependent on treatment arm, evaluable Central Nervous System (CNS) only disease (evaluable by imaging or Cerebrospinal Fluid (CSF) analysis)(\\*\\*)\n* Age from birth to ≤25 years old at the time of trial entry\n* Performance status ≥50 using Karnofsky or Lansky performance scores\n* Life expectancy of ≥8 weeks\n* Adequate bone marrow function documented by:\n\n  * Platelet count ≥50x 10\\^9\u002FL (no platelet transfusion therapy within seven days prior to treatment) unless bone marrow involvement(\\*\\*\\*)\n  * Absolute neutrophil count (ANC) ≥0.75 x 10\\^9\u002FL (no granulocyte colony stimulating factor within 2 days prior to treatment) unless bone marrow involvement(\\*\\*\\*)\n* Adequate hepatic function documented by:\n\n  * Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN)\n  * Total bilirubin ≤1.5 X ULN \\*\\*\\*Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \\>4 x ULN for the local general population\n* Documented negative pregnancy test for female patients of childbearing potential within seven days prior to trial entry\n* Patients of reproductive potential agrees to use effective contraception whilst on trial treatment and for 12 months following treatment discontinuation\n* Written informed consent given by patient and\u002For parents\u002Flegal representative\n\nInclusion criteria applicable to treatment arm I only:\n\n* Male patients of reproductive potential must agree not to donate sperm whilst on trial treatment and for 6 months following treatment discontinuation\n* Adequate renal function, creatinine clearance \\>45 ml\u002Fmin by measurement or estimation (if creatinine levels are normal for the patient's age, using the Cockroft-Gault Equation is sufficient)\n* For patients with bone marrow involvement(\\*\\*\\*) or splenic sequestration, adequate bone marrow function documented by:\n\n  * Platelet count ≥25 x 10\\^9\u002FL (no platelet transfusion therapy within three days prior to treatment)\n  * Haemoglobin level ≥7 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥0.5 x 10\\^9\u002FL (no granulocyte colony stimulating factor within two days prior to treatment)\n* Patients who have received CAR T-cell therapy or other cellular therapies more than 28 days prior must demonstrate recovery from acute toxicities and have measurable disease\n\nInclusion criteria applicable to treatment arm II only:\n\n* Adequate renal function, by measured glomerular filtration rate (GFR) \\>60 ml\u002Fmin\u002F1.73m\\^2 (estimated GFR is not sufficient)\n* For patients with bone marrow involvement(\\*\\*\\*) or splenic sequestration, requirements for bone marrow function do not apply\n\n(\\*) Refractory disease\n\nThe following patients are considered to have refractory disease and can be included in this trial:\n\n* Patients with who do not achieve PR or CR with last therapy\n* Patients with partial response to last therapy (biopsy proven), with no evidence of progression\n\n(\\*\\*) CNS only disease Patients with CNS only disease may be eligible depending on the treatment arm. Please refer to the relevant treatment arm specific eligibility criteria.\n\n(\\*\\*\\*) Bone marrow involvement Patients who have ≥ 25% blasts in the bone marrow are considered to have bone marrow involvement. For these patients, requirements for bone marrow function are dependent on treatment arm. Please refer to the relevant treatment arm specific eligibility criteria.\n\nExclusion Criteria:\n\n* B-cell Acute Lymphoblastic Leukaemia (B-ALL)\u002FB-cell Lymphoblastic Lymphoma (B-LBL)\n* Patients within:\n\n  * 90 days after an allogenic HSCT procedure\n  * 45 days after an autologous HSCT procedure\n  * 28 days of experiencing graft versus host disease (GvHD) requiring systemic therapy, and\u002For immunosuppressive treatment\n  * 14 days of previous investigational treatment\n  * 28 days of receiving craniospinal radiation; or 14 days of any other radiation\n  * For patients who have received any CAR T-cell therapy or other cellular therapies, see treatment arm specific eligibility criteria\n* Patients who have ongoing acute toxicities from most recent lymphoma directed therapy\n* Patients with known DNA repair disorder or known primary immunodeficiency\n* Patients who are pregnant or breastfeeding (exclusively or partially)\n* Patients who cannot regularly be followed up in accordance with the protocol due to psychological, social, geographical or other issues\n* Patients for whom non-compliance with treatment or trial procedures is expected\n* Uncontrolled concomitant infection. Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of trial entry\n* Known HIV positivity\n* Hepatitis B carrier status, history of Hepatitis B Virus or positive serology. A patient is considered as a Hepatitis B Virus carrier or to have (had) Hepatitis B Virus infection in case of:\n\n  * Unimmunized and HBsAg and\u002For anti-HBs antibody and\u002For anti- HBc antibody positive,\n  * Immunized and HBsAg and\u002For anti-HBc antibody positive.\n* Live vaccine within 28 days prior to trial entry\n* Known history of hypersensitivity to any of the treatments or excipients\n\nExclusion criteria applicable to treatment arm I only:\n\n* Central Nervous System (CNS) only disease\n* Patients within 28 days of any CAR-T cell therapy or other cellular therapies\n* Left ventricular shortening fraction (LVSF) \\\u003C27% or left ventricular ejection fraction (LVEF) \\\u003C50%, as determined by ECHO or MUGA, any evidence of pericardial effusion (except trace or physiological) as determined by an ECHO, and any clinically significant arrhythmias\n* Known CD20 negative disease at initial diagnosis\n* Seizure within the last 12 months\n* Prior treatment with CD20 x CD3 bispecific therapy\n* Known hypersensitivity to both allopurinol and rasburicase\n\nExclusion criteria applicable to treatment arm II only:\n\n* Patients within 42 days of any CAR-T cell therapy or other cellular therapies\n* Clinically significant (Grade ≥2) third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n* Steroid treatment for more than a total of seven days in the 14 days prior to trial entry","25 Years",{"count":300,"type":22},210,[25,180],"The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.\n\nThe Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.\n\nExperts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.\n\nChildren from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.",[304],"B-cell Non Hodgkin Lymphoma",{"date":306,"type":37},"2026-02-20",{"date":308,"type":37},"2024-05-02",{"date":310,"type":22},"2033-05-01",{"name":43,"class":44},11,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":321,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100618644","phase-1-a-multi-arm-platform-trial-for-relapsed-neuroblastoma-100618644","NCT07334301","A Multi-Arm, Platform Trial For Relapsed Neuroblastoma","A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma","BEACON2","Inclusion Criteria:\n\n* Disease specific\n\n  * Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS)\\[1\\] definition\n  * High risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed\u002Frelapsed as high-risk neuroblastoma)\n  * Measurable disease by cross sectional imaging or evaluable disease (uptake on MIBG scan with or without bone marrow histology), as per INRC \\[2, 3\\]. Participants with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study General\n  * Age ≥1 year\n  * Signed informed consent from participant, parent or guardian Performance and organ function\n  * Performance Status\n\n    o Lansky (for patients ≤12 years of age) or Karnofsky (for those \\>12) ≥ 50%, (Participants who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score)\n  * Life expectancy of ≥12 weeks\n  * Bone marrow function (within 72 hours prior to randomisation):\n\n    * Platelets ≥ 50 x 109\u002FL (unsupported for 72 hours)\n    * ANC ≥ 0.50 x 109\u002FL (no G-CSF support for 72 hours)\n    * Haemoglobin \\> 8 g\u002FdL (transfusions allowed)\n  * Renal function (within 72 hours prior to randomisation):\n\n    * Absence of clinically significant proteinuria (either early morning urine dipstick ≤ 2+) or if dipstick urinalysis shows \\> 2+ proteinuria, protein: creatinine (Pr\u002FCr) ratio must be \\\u003C 0.5 or a 24 hour protein excretion must be \\\u003C 0.5g\n    * Serum creatinine ≤ 1.5 ULN for age, if higher, a measured GFR (radioisotope or 24 hour urine calculated creatinine clearance) must be ≥ 60 ml\u002Fmin\u002F1.73 m2\n  * Liver function (within 72 hours prior to randomisation):\n\n    o Absence of clinically significant signs of liver dysfunction. AST or ALT ≤ 3.0 ULN and total bilirubin ≤ 1.5 ULN. In patients with liver metastases, AST or ALT ≤ 5 ULN and total bilirubin ≤ 2.5 ULN is allowed.\n  * Coagulation:\n\n    * Participants must not have an active uncontrolled coagulopathy.\n    * Anticoagulation is permitted as long as the INR or APTT is within therapeutic limits (according to the medical standard of the institution) and the participant has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment.\n  * Blood pressure below 95th centile for age and sex. Participants ≥18 years of age should have a blood pressure ≤150\u002F90 mmHg (within 72 hours prior to randomisation). Use of antihypertensive medication is permitted.\n\nTier 2 Specific Inclusion Criteria\n\n• More than one relapse event or ineligible for Tier 1.\n\nNB- The following previous treatments are allowed provided that the principal investigator expects a favourable benefit\u002Frisk assessment (e.g. patients could derive potential benefit from the Tier 2 combination):\n\n* bevacizumab,\n* any anti-GD2 antibody given with chemotherapy ('chemo-immunotherapy')\n* previous treatment with temozolomide with irinotecan\n\nExclusion Criteria:\n\n* • Known contraindication or hypersensitivity to:\n\n  * Any study drug or component of the formulation\n  * Chinese hamster ovary products or other recombinant human or humanised antibodies.\n  * Participants with mild previous hypersensitivity reactions to anti-GD2 antibodies may be included, but those with severe (or G4) hypersensitivity reactions to anti-GD2 antibodies will be excluded.\n\n    * Clinically significant neurological toxicity, uncontrolled seizures or objective peripheral neuropathy (\\> grade 2). (Unresolved neurological deficits from previous spinal cord compression or surgeries are acceptable). Participants with previous ≥ Grade 3 motor neurotoxicity secondary to anti-GD2 are excluded, even if recovered\n    * Prior severe arterial thrombo-embolic events (e.g. cardiac ischemia, cerebral vascular accident, peripheral arterial thrombosis) or any ongoing arterial thrombo-embolic events\n    * A history of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.\n    * Patients that are allergic to all therapies for Pnemocystis jirovecii pneumonia and can thus not receive prophylaxis for PJP\n    * Uncontrolled infection\n    * Inadequate recovery from prior surgery with ongoing ≥ Grade 3 surgical complications. Grade ≥ 2 wound dehiscence.\n    * Recent surgical procedures (at start of trial treatment). Patient can be randomised up to 48hr prior to these periods being completed provided that trial treatment only starts after complying with all of them:\n  * Core biopsies within previous 24hr\n  * Open excisional biopsies within previous 48hr\n  * Major surgery within previous 2 weeks\n  * Bone marrow aspirates\u002Ftrephines, within previous 48hr\n  * Tunnelled central line insertion within previous 48hr\n\n    • Washout from prior treatments (at start of trial treatment):\n  * Chemotherapy within previous 2 weeks (1 week for oral metronomic chemotherapy regimens)\n  * Any anti-GD2 therapy within previous 2 weeks\n  * Craniospinal radiotherapy or MIBG therapy within previous 6 weeks\n  * Radiotherapy to the tumour bed within previous 2 weeks (no washout for palliative radiotherapy)\n  * Myeloablative therapy with haematopoietic stem cell rescue (autologous stem cell transplant) within previous 8 weeks\n  * Allogeneic stem cell transplant within previous 12 weeks (with absence of active ≥ G2 acute GVHD)\n  * 14 days or 5 half-lives (whichever occurs later) from last administration of an IMP in an IMP-trial\n\n    * Bleeding metastases (participants with CNS metastases can be enrolled as long as the metastases are not bleeding). At least 6 months from any ≥ G3 haemoptysis or pulmonary haemorrhage\n    * Use of enzyme inducing anticonvulsants within 72hr of start of trial treatment\n    * Conditions that increase the risk of bevacizumab-related toxicities:\n  * History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation)\n  * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to study enrolment\n  * Current chronic intestinal inflammatory disease\u002Fbowel obstruction\n\n    * Intolerance to galactose and fructose, lactase deficiency, and\u002For defect of absorption of galactose and fructose\n    * Males or females of reproductive potential may not participate unless they agree to use a highly effective method of birth control, i.e. with a failure rate of less than 1% per year, (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner), for the duration of study therapy and for up to 6 months after the last dose of trial drugs. A negative urine or serum pregnancy test must be obtained within 72 hours prior to dosing in females who are post-menarche.\n    * Pregnant or lactating participant\n    * Live or live-attenuated vaccines given within previous 28 days prior to study enrolment\n    * Any uncontrolled medical condition that poses an additional risk to the participant\n\nTier 1 Specific Exclusion Criteria\n\n* More than one relapse\u002Fprogression event after the start of high risk neuroblastoma therapy\n* Previous treatments that are not allowed\n\n  * Bevacizumab for relapsed neuroblastoma. Patients who have received BIT for refractory disease are not excluded, providing no progression of disease during this treatment occurred\n  * Treatment with any anti-GD2 antibody given with chemotherapy ('chemo-immunotherapy') for treatment of relapsed neuroblastoma. Prior treatment with chemo-immunotherapy for refractory disease is allowed, provided no disease progression during this therapy.","1 Year",{"count":323,"type":22},160,[325,25],"PHASE1","Neuroblastoma is one of the most common solid childhood tumours, and a major cause of cancer-related death in children. More than 1200 children\u002Fyoung adults a year are diagnosed in USA and Europe. Around 600 of these cases are considered high-risk, which means the cancer is more difficult to treat successfully. Despite improvements in survival over recent decades, a significant proportion of patients with high-risk neuroblastoma have disease that does not respond to standard treatments (refractory neuroblastoma) or comes back after completion of standard frontline treatment (relapsed neuroblastoma). Therefore, there is a need to develop new treatment strategies and test new drugs to improve outcomes for children with neuroblastoma.\n\nAims Of The BEACON2 Trial\n\n* To improve survival for patients with relapsed neuroblastoma by developing new treatment combinations\n* To evaluate new treatment combinations in relapsed neuroblastoma, within a phase I\u002FII trial that can impact clinical practice, while also allowing dose confirmation for new promising combinations\n* To evaluate the safety, activity, efficacy and impact on quality of life of these new treatment combinations in relapsed neuroblastoma patients\n* To improve our understanding of relapsed neuroblastoma biology and advance the development of targeted therapies using biomarkers, by conducting a comprehensive biomarker sample collection.\n\nTrial Design BEACON2 is a randomised phase I\u002Fphase II, open label, international trial. The trial will have two tiers: Tier 1 will be the main randomisation for two treatment arms initially. Participants will be randomised at trial entry to receive one of the available regimens, treatment A or treatment B. Tier 2 will include smaller dose expansion\u002Fconfirmation cohorts for more novel experimental treatment combinations (Arm C and future arms), with the potential for them to be moved to Tier 1.\n\nCurrent Tier 1 (Randomisation Tier) Treatment Arms in the BEACON2 Trial:\n\nArm A: dbIT Treatment with dinutuximab beta, irinotecan, and temozolomide, 3 weekly x12 cycles Arm B: BIT Treatment with bevacizumab, irinotecan, and temozolomide, 3 weekly x12 cycles\n\nCurrent Tier 2 (Registration Only Tier) Treatment Arms in the BEACON2 Trial:\n\nArm C: dbBIT Treatment with dinutuximab beta, bevacizumab, irinotecan, and temozolomide, 3 weekly x12 cycles\n\nPatient Population and Sample Size Patients aged ≥1 years of age with relapsed neuroblastoma. For each arm in Tier 1, up to 75 patients will be recruited to complete phase 2 investigations. For each arm in Tier 2, 10 patients will be recruited to complete phase I investigations. Approximately 160 participants are initially planned, 75 in each arm of Tier 1 and 10 participants for one dose-confirmation cohort in Tier 2.\n\nThe study is expected to recruit patients for 3 years, and then finish patient follow-up after an additional 5 years.\n\nTranslational Sub-study \u002F Biological Studies\n\nIt is standard of care for patients diagnosed with relapsed neuroblastoma to:\n\n* Have had a tumour sample collected at point of initial diagnosis (either during biopsy or surgery)\n* Have bloods collected before they start and during treatment for their relapsed neuroblastoma\n* Have a bone aspirate\u002Ftrephine procedure in order to help confirm relapse. These samples provide very important opportunities for further research, and the study investigators would like to make full use of these opportunities by collecting the analysis already performed on these samples and collect some additional samples (at the same time as the standard ones) to learn and understand more about neuroblastoma and its treatment. Samples will undergo research analysis at the national SIOPEN reference laboratories.",[328],"Relapsed Neuroblastoma",[330],"Neuroblastoma","2026-01-05",{"date":333,"type":37},"2026-01-12",{"date":335,"type":37},"2024-11-11",{"date":337,"type":22},"2030-12-31",{"name":43,"class":44},23,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"100615606","personalised-pharmacometabolomic-guided-strategy-trial-to-optimise-treatment-for-hypertension-100615606","NCT07294794","Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension","Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension (HYPERMARKER)","HYPERMARKER","Inclusion Criteria:\n\n1. Systolic blood pressure ≥140 mmHg on any blood pressure recording method (office, home or ambulatory)\n2. Age 18 years or older\n3. Clinical indication for antihypertensive therapy\n\nExclusion Criteria:\n\n1. Systolic blood pressure ≥180 mmHg on any blood pressure recording method (office, home or ambulatory)\n2. Potential secondary cause of hypertension, including but not limited to renovascular hypertension, endocrine conditions, chronic kidney disease, coarctation of the aorta or medication related.\n3. Three or more current anti-hypertensive medications\n4. Planned intervention for hypertension, such as renal denervation\n5. Severe kidney disease (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin)\n6. Diagnosis of known heart failure with left ventricular ejection fraction \\\u003C40%\n7. Stroke or myocardial infarction within the last 6 months\n8. Pregnancy, planning for pregnancy, or breastfeeding\n9. Participant whom the Clinical Investigator deems otherwise ineligible",{"count":90,"type":22},[205],"High blood pressure (hypertension) affects 1 in 3 adults and can lead to serious health issues like strokes and heart attacks. Medication can lower blood pressure (BP) and reduce complications. Choosing the right medication can be challenging, potentially leading to side effects or poor control.\n\nHYPERMARKER is testing whether providing doctors with additional information when they make a blood pressure prescription choice can improve a patient's overall blood pressure management. This includes relevant clinical information and personalised results from blood tests, brought together using computer programs (machine learning)- 'smart approach'. The blood tests check for small substances naturally produced by the body called metabolites\n\nDeveloped with patient and public involvement, this proof-of-concept clinical trial will recruit 400 people across four sites in the UK, Spain, the Netherlands, and Germany. Participants must have a recent high blood pressure reading with a clinical need for medication. After providing written consent, they will provide a blood sample (to measure their metabolites) and receive a BP monitor connected to a smartphone app allowing them to measure and record their BP at home throughout the trial.\n\nThe study's main outcome is home BP readings. Participants will also complete web-based questionnaires about their health, diet, treatment experience, and healthcare usage.\n\nParticipants will be randomly assigned to two groups. Group A will receive medication based on standard clinical practice up-front, then investigators will receive output from the smart approach to refine the choice of treatment. In Group B, investigators will receive the output from the 'smart approach' initially, with further updates provided later.\n\nOnly medications licensed for hypertension will be used. All prescriptions are determined by clinicians throughout the trial.\n\nThe trial lasts 9-16 weeks. At the end, participants and their usual doctor get a copy of their BP readings and medication to guide their long-term care.",[352],"Hypertension",[354,355,356,357,358],"metabolomics","pharmacometabolomics","personalised management","blood pressure","machine learning","2025-12-08",{"date":361,"type":37},"2025-12-19",{"date":363,"type":22},"2026-01-19",{"date":365,"type":22},"2026-12-31",{"name":43,"class":44},4,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":200,"sex":18,"minAge":19,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":223},"100587079","de-stressing-the-brain-can-eating-grapes-during-periods-of-mental-stress-protect-brain-and-vascular-health-in-young-adults-100587079","NCT06923722","De-stressing the Brain: Can Eating Grapes During Periods of Mental Stress Protect Brain and Vascular Health in Young Adults","A Placebo-controlled, Randomized, Double-masked, Cross-over Acute Intervention Study Investigating the Effects of Grape Polyphenols on Cerebral Oxygenation, Cognitive and Vascular Function in the Context of Mental Stress in Young Adults","Inclusion Criteria:\n\n* Males and females\n* 18 - 40 years old\n\nExclusion Criteria:\n\n* Smokers\n* Consumes \\> 21 units of alcohol per week\n* History of cardiovascular, respiratory, metabolic, liver or inflammatory diseases\n* Suffers from blood-clotting disorders\n* Allergies or intolerances to foods\n* On a weight reducing dietary regiment\n* Currently taking dietary supplements, including fatty acids and vitamins\n* On long-term medication or have been on antibiotics in the last 3 months\n* Has an infection at present (e.g. cold) or viral infection","40 Years",{"count":377,"type":22},44,[205],"The main aim of the current study is to investigate whether consuming grapes rich in flavonoids just before mental stress can protect cerebrovascular and peripheral vascular function, mood and cognition, from the negative effects of mental stress in young healthy adults. A second, exploratory aim, will further address whether quality of habitual diet, microbiome health (composition; metabolites production e.g. Short-chain fatty acids) and levels of cardiorespiratory fitness play a role on the beneficial effects of grapes during mental stress. All participants will receive a high-flavonoid grape intervention (60 g freeze-dried grape powder, equivalent to 300 g fresh grapes) and a low-flavonoid grape intervention (60 g powdere isocaloric-matched control). It is hypothesized that the high-flavonoid grape intervention will improve cortical oxygenation and cognitive function in the context of mental stress, and prevent the stress-induced decline in peripheral endothelial function following stress. Furthermore, it is hypothesized that individuals with poorer diets, cardiorespiratory fitness and a poorer gut microbiome will benefit more from the grape intervention in the context of mental stress.",[381],"Healthy",[383,384,385,386,387,388,389,390,391],"vascular function","flavonoids","cerebral oxygenation","mental stress","cognition","executive function","grape","Flow-mediated dilatation","Functional Near-Infrared Spectroscopy","2025-12-03",{"date":394,"type":37},"2025-12-04",{"date":396,"type":37},"2025-04-01",{"date":398,"type":22},"2026-03-31",{"name":43,"class":44},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":200,"sex":18,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":424},"100614916","glycaemic-outcomes-with-whey-protein-in-ageing-100614916","NCT07285811","GLycaemic Outcomes With Whey Protein in ageING","Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes","GLOWING","* Male or female\n* 75-90 years old\n* Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \\>6.5% in clinic or in SportExR)\n* Stable body mass (body mass index (BMI) ≤40kg\u002Fm2)\n* Generally healthy, assessed via a General Health Questionnaire (GHQ)\n* Some residual beta-cell activity (confirmed with urine test on induction)\n* Normal or moderately increased albuminuria (needs to be below 300mg\u002Fg)\n* Normal, mildly or moderately decreased glomerular filtration rate (GFR) (needs to be above 45ml\u002Fmin\u002F1.732).\n* Able and willing to attend SportExR a total of 5 times: 1 induction and 2 testing visits and 2 return check-up visits.\n\nExclusion Criteria:\n\n* \\\u003C75 years old and over 90 years of age\n* Currently on fast-acting insulin therapy (i.e., Humalog)\n* Confirmed uncontrolled diabetes (HbA1C \\>10% or 85mmol\u002Fmol).\n* Currently on GLP-1 therapy\n* Habitual smoker or vaper\n* Veganism\n* Lactose or dairy intolerance\n* Coeliac or gluten intolerance\n* History of gastrointestinal disease\n* Experienced a hyperglycaemic or hypoglycaemic event requiring treatment in the past 12 months\n* Recent Ischemic stroke (\\\u003C3 months).\n* Use of anticoagulants (e.g. warfarin, rivaroxaban)\n* Considered unwilling or unable to comply with the study protocol requirements by the research team","75 Years","90 Years",{"count":411,"type":22},32,[205],"The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes.\n\nThe primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 75-90 years of age, living with type 2 diabetes, compared with a non-protein placebo.\n\nParticipants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.",[415],"Type 2 Diabetes","2025-12-02",{"date":418,"type":37},"2025-12-16",{"date":420,"type":22},"2025-12",{"date":422,"type":22},"2026-12",{"name":43,"class":44},2,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":223},"100605297","phase-3-apixaban-to-prevent-venous-thromboembolism-in-ambulatory-lung-cancer-patients-undergoing-systemic-anticancer-treatment-100605297","NCT07160686","Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","A Phase III, Multicentre, Double Blind, Placebo-Controlled, Randomised Clinical Trial of Apixaban THROMBOprophylaxiS TO Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","THROMBO-STOP","Inclusion criteria\n\n* Age ≥ 16 years\n* Newly diagnosed locally advanced or metastatic primary lung cancer (histologically\u002F cytologically confirmed) or disease progression after complete or partial remission commencing a new course of SACT alone or as CRT\n* Ambulatory (receiving outpatient SACT)\n\nExclusion criteria\n\n* Hypersensitivity to apixaban or to any of the listed SmPC excipients\n* Active clinically significant bleeding\n* Lesion or condition considered a significant risk factor for major bleeding\n* Hepatic disease associated with impaired synthetic function\n* Platelet count \\\u003C 50 x 109 \u002FL\n* Elevated liver enzymes ALT\u002FAST \\> 2 x ULN or total bilirubin ≥ 1.5 x ULN\n* Renal failure (creatinine clearance \\\u003C 15ml\u002Fmin)\n* Weight \\\u003C 40kg\n* Estimated life expectancy \\\u003C 6 months\n* Continuous anticoagulation (e.g., unfractionated heparin, low molecular weight heparins, heparin derivatives and oral anticoagulants) for other medical conditions\n* The usage of medications contraindicated with apixaban\n* Pregnancy\n* Breast feeding\n* Judgement by the Investigator that the participant is unsuitable to participate in the trial and the participant is unlikely to comply with trial procedures, restrictions and requirements\n* Inability to consent\n* Receiving SACT for potentially resectable \u002F resectable lung cancer as part of neo-adjuvant or adjuvant treatment\n* SACT with significant potential DDI with apixaban (section 7.2.3)",{"count":434,"type":22},1456,[180],"The aim of this trial is to find out if a tablet called apixaban can reduce blood clots in people with lung cancer having chemotherapy or similar treatments. Apixaban is a type of oral anticoagulant (\"blood thinner\") that makes the blood less sticky to prevent blood clots forming.\n\nThe trial is trying to find out if apixaban it can reduce blood clots in people with lung cancer.\n\nParticipants will receive the following treatment:\n\n• Apixaban or placebo, 2.5mg taken by mouth twice a day for 6 months. This treatment will be taken in addition to any treatment that they are receiving to treat their lung cancer.\n\nParticipants will need to:\n\n* Sign a consent form to enter the trial.\n* Take the trial treatment as directed by the research team\n* Complete a participant diary to record when they took the trial treatment\n* Complete the Quality of Life and Health resource use questionnaires.\n* Female participants of childbearing potential must use adequate contraception during the trial and for at least 2 days after trial treatment has finished.",[438],"Thromboprophylaxis","2025-09-01",{"date":441,"type":37},"2025-09-08",{"date":443,"type":22},"2026-03-02",{"date":445,"type":22},"2030-03-30",{"name":43,"class":44},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":455,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":223},"100416297","phase-4-preventing-stroke-premature-death-and-cognitive-decline-in-a-broader-community-of-patients-with-atrial-fibrillation-100416297","NCT04700826","Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation","Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial","DaRe2THINK","Inclusion Criteria:\n\n1. Diagnosis of AF (previous, current or chronic)\n2. Age at enrolment ≥55 years to ≤73 years\n\nExclusion Criteria based on coding in Primary Care:\n\n1. Prior documented stroke, transient ischaemic attack or systemic thromboembolism.\n2. Combination of multiple known risk factors for stroke where oral anticoagulation would ordinarily be started, including: Heart failure; Hypertension; Age 65 years or older; Diabetes mellitus; Previous myocardial infarction, peripheral artery disease or aortic plaque; and\u002For Female gender.\n3. Any prior history of intracranial bleeding.\n4. Prior major bleeding requiring hospitalisation in the last 3 years.\n5. Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain\u002Fspinal\u002Fophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancers with high bleeding risk.\n6. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 measured within the last 12 months.\n7. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).\n8. Documented diagnosis of dementia.\n9. Hypersensitivity or known intolerance to direct oral anticoagulants.\n\nExclusion criteria based on review by Primary Care staff:\n\n1. Currently receiving an anticoagulant.\n2. Any clinical indication for anticoagulation.\n3. Active clinically-significant bleeding.\n4. Life expectancy estimated \\\u003C2 years.\n5. Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.\n6. Currently participating in another clinical trial.\n7. Women of childbearing potential.","55 Years","73 Years",{"count":458,"type":22},3000,[460],"PHASE4","The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS - primary 2 secondary) is designed to operationalise efficient, nationwide, primary care approaches for randomised trials embedded within the UK National Health Service (NHS), providing automated screening, targeted patient enrolment and 'no-visit' follow-up through innovations in big data and technology solutions.\n\nDaRe2THINK will be the first exemplar of this system, and is appropriately focused on the intersection of key national priorities for healthcare; atrial fibrillation (a heart rhythm condition that will double in prevalence in the next few decades) and the impact this condition has on stroke, thromboembolic events, cognitive impairment and vascular dementia. The trial will test the hypothesis that direct oral anticoagulants (DOACs), now commonly used in older patients with atrial fibrillation (AF), are effective and cost-effective at reducing major adverse clinical events in younger patients at low or intermediate risk of stroke, and can reduce the high rate of cognitive decline. The health technology innovations noted above will allow the investigators to answer this important clinical question, as well as demonstrate the capacity and potential of this system for future, large-scale healthcare-embedded clinical trials for patient benefit.",[463],"Atrial Fibrillation",[465,466,467,468],"Atrial fibrillation","anticoagulation","stroke","dementia","2025-05-13",{"date":471,"type":37},"2025-05-16",{"date":473,"type":37},"2021-06-01",{"date":475,"type":22},"2031-01",{"name":43,"class":44},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":168},"100587766","reducing-deaths-after-surgery-in-low--and-middle-income-countries-a-pilot-cluster-randomised-trial-100587766","NCT06932653","Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial","SurgPASS","Inclusion criteria:\n\n* Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm\n* Patient must not be pregnant\n* Adults only (greater than or equal to 18 years old)\n\nExclusion criteria:\n\n* Minimally invasive surgery\n* Surgery for appendicitis",{"count":486,"type":22},300,[205],"SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.",[490],"Post-operative Complications",[492,493,494],"pilot","cluster","surgical safety","2025-04-10",{"date":497,"type":37},"2025-04-17",{"date":499,"type":22},"2025-06-01",{"date":501,"type":22},"2026-01-31",{"name":43,"class":44},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":510,"targetDuration":512,"studyType":135,"phases":4,"briefSummary":513,"conditions":514,"keywords":517,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":526},"100575570","a-global-prospective-cohort-study-on-outcomes-of-appendicectomy-for-appendicitis-100575570","NCT06774001","A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis","AlliGatOr","Inclusion Criteria:\n\n* Age: There are no age restrictions, although, if appropriate participating hospitals can choose to only include children or only adults, based on an age cut-off of their choice.\n* Procedure: All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes patients who went theatre with suspect appendicitis even if the intraoperative or pathology results found a different diagnosis, so long as an appendicectomy was performed. It also includes patients who went to theatre for reasons other than suspected appendicitis but were found to have appendicitis intraoperatively and underwent appendicectomy. This includes interval appendicectomy and right hemicolectomy if performed for acute appendicitis.\n* Approach: Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.\n\nExclusion Criteria:\n\n* Indication: Appendicectomy for any indication other than suspected or confirmed appendicitis should be excluded. For example, patients having appendicectomy for known appendiceal neoplasm.\n* Procedure: Patients having appendectomy as part of another surgical procedure should be excluded. For example, patients having removal of appendix as part of a colon cancer procedure are not eligible for inclusion.\n* Approach: Natural orifice surgery and endoscopic treatment for suspected appendicitis are excluded.\n* Previous appendicectomy: Patients having surgery for stump appendicitis are excluded.\n* Return to theatre: Patients should be entered into study only once. A patient returning to theatre after appendectomy should not be re-entered as a new patient.",{"count":511,"type":22},14000,"30 Days","This study aims to assess and improve the global management of appendicitis, the most common emergency surgery, by examining various aspects of emergency care systems worldwide. Appendicitis is a time-sensitive condition, and delays in diagnosis or treatment can lead to complications, affecting patient outcomes and increasing healthcare costs. The study uses appendicitis as a \"tracer condition\" to explore how different healthcare systems manage emergency care, focusing on factors like access, quality, and efficiency. By gathering data from hospitals worldwide, the study seeks to identify areas where emergency surgical care can be improved, particularly in low- and middle-income countries (LMICs).\n\nThe main goal is to identify gaps in emergency care systems, using a set of key performance measures (KPMs) that assess access to care, the quality of surgical treatment, and patient safety. These include factors like the time from symptom onset to first surgical assessment, the rate of appendectomy performed via minimally invasive (laparoscopic) surgery, and postoperative complications. The study aims to collect data on at least 14,000 patients from around 500 hospitals globally between February and May 2025. The data will be analyzed by hospital income group (from low to high) to understand how different resource levels impact outcomes and to help guide future policy and practice improvements.\n\nThe study also includes two sub-studies that focus on specific issues in surgical care. The Sustainability and Waste Management sub-study aims to explore how hospitals manage waste and sustainability practices in operating theatres. This sub-study is part of global efforts to reduce carbon emissions in healthcare settings. The Financing sub-study examines the financial burden of appendicectomy, particularly the out-of-pocket costs for patients in LMICs. It will explore how the costs of open vs. laparoscopic surgery differ and investigate the impact of these costs on patients.\n\nBy combining global data on clinical outcomes with information on hospital resources and patient finances, this study hopes to provide valuable insights into how to improve emergency surgical care across diverse settings, making recommendations that can lead to better access to safe, timely, and affordable treatment for appendicitis worldwide.",[515,516],"Appendicitis","Appendectomy",[518,515,516],"Appendicectomy","2025-03-27",{"date":521,"type":37},"2025-04-02",{"date":523,"type":37},"2025-02-03",{"date":420,"type":22},{"name":43,"class":44},7,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":200,"sex":18,"minAge":134,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":223},"100584301","mpox-comprehensive-assessment-for-responsive-immunisation-in-emergency-outbreaks-100584301","NCT06887556","Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks","MPOX CARE","Inclusion Criteria:\n\n* Healthy males and females aged between ages 5-80 years, who are able and willing to provide informed consent and will comply with the study requirements.\n* Group 1 (suspected exposure cohort) only\n\n  * Live within or adjacent to an epidemiologically identified region of Mpox transmission\n  * Close contacts of those with microbiologically confirmed Mpox\n* Group 2 (post-exposure\u002Fvaccinated cohort) only\n\n  * Previous clinically or microbiologically confirmed Mpox or confirmed previous vaccination with a smallpox\u002FMVA vaccine\n  * Fully recovered from Mpox infection\n* Group 3 (control cohort) only:\n\n  * Asymptomatic with no known exposure to Mpox\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent to take part\n* Unwilling or unable to comply with study procedures\n* History of any suspected or confirmed disorder of the immune system that, in the opinion of the investigators, might impair the results of the study\n* Have a bleeding disorder deemed significant by a member of the study team\n* Pregnant or breast-feeding females\n* Group 1 (suspected exposure cohort) only\n\n  * Known history of Mpox infection\n  * Current symptoms consistent with Mpox\n  * Known exposure to Mpox in the last month\n* Group 2 (post-exposure\u002Fvaccinated cohort) only\n\n  * Participants with any ongoing symptoms of Mpox, indicating incomplete recovery.\n* Group 3 (control cohort only)\n\n  * Symptoms of Mpox\n  * Known exposure to Mpox in the last month","80 Years",{"count":536,"type":22},650,[205],"The MPXV CARE study principally aims to use clinical and epidemiology data to target specific individuals willing and able to provide appropriate and proportionate biological samples to develop novel immune diagnostics that support models of disease burden and future vaccine utilisation.",[540],"Mpox","2025-03-19",{"date":543,"type":37},"2025-03-20",{"date":545,"type":37},"2025-02-05",{"date":422,"type":22},{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":556,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":583},"100382220","phase-3-perioperative-respiratory-care-and-outcomes-for-patients-undergoing-high-risk-abdominal-surgery-100382220","NCT04256798","Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery","PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries","PENGUIN","Inclusion Criteria:\n\n* Adults and children aged 10 years or over\n* Elective or emergency abdominal surgery via midline laparotomy with an anticipated abdominal incision of at least 5cm in length\n* Written informed consent of patient (signature or a fingerprint)\n\nExclusion Criteria:\n\n* Patients undergoing caesarean section\n* Patients with a documented or suspected allergy to chlorhexidine\n* Patient unable to complete postoperative follow-up (not contactable after discharge)\n* Previous enrolment in PENGUIN within the past 30 days\n* American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)","10 Years","100 Years",{"count":559,"type":22},12942,[180],"PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery.\n\nPatients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.",[563,564,565,566,567,568,569,570,571,572,573,574],"Infection","Pneumonia","Surgical Site Infection","Wound Infection","Surgical Wound Infection","Postoperative Complications","Anesthesia","Communicable Disease","Pathologic Processes","Perioperative Complication","Chlorhexidine","Laparotomy","2025-02-18",{"date":577,"type":37},"2025-02-19",{"date":579,"type":37},"2020-11-13",{"date":581,"type":22},"2026-06-01",{"name":43,"class":44},37,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":556,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":223},"100528720","disposable-versus-reusable-drapes-and-gowns-for-green-operating-theatres-100528720","NCT06164444","Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres","Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres","DRAGON","Inclusion criteria:\n\n* Patients with at least one incision that is ≥5cm in adults and ≥3cm in children aged under 16 years. This can include both open and minimally-invasive surgery providing at least one incision meets this criteria.\n* Patients with a clean-contaminated, contaminated, or dirty surgical wound. Definitions of contamination are given in Table 2.\n* Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery.\n* Any operative indication (including caesarean section).\n* Patients aged 10 or over.\n\nExclusion criteria\n\n* Adults with an incision \\\u003C5 cm and incision \\\u003C3cm in children aged under 16 years.\n* Patients undergoing procedures with a clean surgical wound only.",{"count":593,"type":22},26800,[205],"Multicentre non-inferiority cluster randomised trial testing Disposable versus Reusable drApes and Gowns for green OperatiNg theatres. A pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.",[565],[598,599,600,601],"Surgery","global surgery","SSI","surgical site infection","2025-02-14",{"date":577,"type":37},{"date":605,"type":37},"2024-11-12",{"date":607,"type":22},"2026-07-31",{"name":43,"class":44},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":200,"sex":18,"minAge":19,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100561233","phase-4-safety-and-immunogenicity-of-rvsvg-zebov-gp-vaccination-when-dosed-concurrently-with-mrna-covid-19-vaccine-booster-doses-100561233","NCT06587503","Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrently With mRNA COVID-19 Vaccine Booster Doses","EbolaCov: A Phase IV, Single-centre, Single-blinded, Randomized Controlled Trial to Assess Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With mRNA COVID-19 Vaccine Booster Doses in Healthy African Adults","Inclusion Criteria:\n\n* Healthy male and female adults between ages 18-50 years, who are able and willing to provide written informed consent and will comply with the study requirements.\n* Already completed a primary course of COVID-19 immunisation (any World Health Organisation approved primary immunisation course is acceptable).\n\nExclusion Criteria:\n\n* Unwilling or unable to provide written informed consent to take part\n* Unwilling or unable to comply with study procedures\n* Previously received an Ebola vaccine or previous exposure to Ebola virus (including serological and clinical diagnoses, irrespective of viral strain)\n* Not received a primary course of COVID-19 immunisation\n* History of any suspected or confirmed disorder of the immune system that, in the opinion of the Investigators, might impair the results of the study\n* Use of immunosuppressant medication within the past 6 months (excluding topical steroids or oral steroid courses lasting \\\u003C7 days)\n* Current diagnosis or treatment of cancer (unless non-melanomatous skin cancer)\n* Have a bleeding disorder deemed significant by study doctor\n* Pregnant or breast-feeding females\n* Able to avoid close contact with vulnerable individuals, including via high-risk blood and bodily fluids for 6 weeks following vaccination to reduce the risk of transmission to vulnerable individuals (e.g. immuno-compromised individuals, individuals receiving immunosuppressive therapy, pregnant or breast-feeding women, children \\\u003C1 year of age).\n* Unable to prevent contact of their blood or bodily fluids with farm animals in the 6 weeks following vaccination\n* Plan to donate blood in the 6 weeks following vaccination\n* Hypersensitivity to any active substances, excipients, or rice protein.\n* History of anaphylaxis to any component of vaccine formulation.","50 Years",{"count":618,"type":22},72,[460],"Concurrent vaccination scheduling for key target populations in Rwanda, such as healthcare workers, may confer significant advantages in the provision of vaccine coverage to several infectious diseases. This is a phase IV vaccine trial that looks to establish if two licenced vaccines, the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid (mRNA) COVID vaccine for protection against SARS-CoV-2 virus, given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response.",[622,623],"Ebola Virus Disease","COVID-19","2024-09-09",{"date":626,"type":37},"2024-09-19",{"date":628,"type":22},"2024-10",{"date":630,"type":22},"2025-05",{"name":43,"class":44},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":645,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":526},"100551885","a-stratified-multi-arm-multi-site-randomised-platform-trial-aiming-to-reduce-the-incidence-of-post-operative-ssi-100551885","NCT06465901","A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI","MARLIN: Stratified, Multi-arm, Multi-stage Factorial Randomised Platform Trial Aiming to Reduce the Incidence of Post-operative Surgical Site Infection (SSI).","MARLIN","Inclusion Criteria:\n\n* Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated, or dirty surgical wound. Definitions and examples of contamination are given in Table 1.\n* Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.\n* Any operative indication for abdominal surgery (excluding caesarean section; see exclusion criteria).\n* Patient able and willing to provide written informed consent (signature or a fingerprint) prior to surgery (including emergency cases).\n* Patients aged 5 years and over. (This criteria MUST be made country-specific. Each country will decide the lower (and upper, if applicable according to local regulations age limit for the trial. This will be dependent on country-specific regulatory approvals. Age eligibility will vary by country.)\n\nExclusion Criteria:\n\n* Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).\n* Patients undergoing clean surgical procedures.\n* Patients undergoing an obstetrics procedure, including caesarean sections.",{"count":641,"type":22},10092,[205],"MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).",[565],[646,599,600,601],"surgery","2024-06-18",{"date":649,"type":37},"2024-06-20",{"date":651,"type":22},"2024-09-01",{"date":653,"type":22},"2026-09-30",{"name":43,"class":44},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":663,"enrollmentInfo":664,"targetDuration":4,"studyType":23,"phases":666,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":678,"locationsCount":4},"100528773","task-sharing-in-inguinal-hernia-repair-between-surgeons-and-non-surgeon-physicians-100528773","NCT06165133","Task Sharing in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians","Task Shifting in InGuinal hErnia Repair Between Surgeons and Non-surgeon Physicians. A Multicentre Randomised Controlled Non-inferiority Trial.","TIGER","Inclusion Criteria\n\n* Patients older than \\\u003C18 years\\> (male or female) and less or equal to 60 years\n* Primary inguinal hernia (unilateral) eligible for elective inguinal hernia repair\n* Primary bilateral, but only one side being repaired\n* Written informed consent of patient (signature or a fingerprint)\n\nExclusion Criteria\n\n* Complex inguinal hernias: recurrent, obstructive, or femoral hernias\n* Bilateral inguinal hernias undergoing simultaneous repair\n* Inguinal hernias needing emergent surgical repair (e.g., incarcerated)\n* Patient unable to complete post-operative follow-up","60 Years",{"count":665,"type":22},1782,[205],"TIGER is a multicentre, 2-arm, parallel group, assessor blinded, non-inferiority randomised controlled trial with an internal pilot to assess if non-surgeon physicians (NSPs) can effectively perform mesh inguinal hernia repair compared to fully trained surgeons in adult patients with non-complicated inguinal hernia.",[669],"Inguinal Hernia",[646,599,671],"inguinal hernia","2024-05-29",{"date":674,"type":37},"2024-05-30",{"date":676,"type":22},"2024-06-01",{"date":289,"type":22},{"name":43,"class":44},{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":686,"targetDuration":4,"studyType":23,"phases":688,"briefSummary":689,"conditions":690,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":700},"100410545","phase-1-far-rms-an-overarching-study-for-children-and-adults-with-frontline-and-relapsed-rhabdomyosarcoma-100410545","NCT04625907","FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma","FaR-RMS","Inclusion Criteria for study entry - Mandatory at first point of study entry\n\n1. Histologically confirmed diagnosis of RMS (except pleomorphic RMS)\n2. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nPhase 1b Dose Finding - IRIVA Inclusion\n\n1. Entered in to the FaR-RMS study at diagnosis\n2. Very High Risk disease\n3. Age \\>12 months and ≤25 years\n4. No prior treatment for RMS other than surgery\n5. Medically fit to receive treatment\n6. Adequate hepatic function:\n\n   1. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert's syndrome\n   2. ALT or AST \\\u003C 2.5 X ULN for age\n7. Absolute neutrophil count ≥1.0x 109\u002FL\n8. Platelets ≥ 80 x 109\u002FL\n9. Adequate renal function: estimated or measured creatinine clearance ≥60 ml\u002Fmin\u002F1.73 m2\n10. Documented negative pregnancy test for female patients of childbearing potential\n11. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n12. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion\n\n1. Weight \\\u003C10kg\n2. Active \\> grade 2 diarrhoea\n3. Prior allo- or autologous Stem Cell Transplant\n4. Uncontrolled inter-current illness or active infection\n5. Pre-existing medical condition precluding treatment\n6. Urinary outflow obstruction that cannot be relieved prior to starting treatment\n7. Active inflammation of the urinary bladder (cystitis)\n8. Known hypersensitivity to any of the treatments or excipients\n9. Second malignancy\n10. Pregnant or breastfeeding women\n\nFrontline chemotherapy randomisation Very High Risk - CT1a Inclusion\n\n1. Entered in to the FaR-RMS study at diagnosis\n2. Very High Risk disease\n3. Age ≥ 6 months\n4. Available for randomisation ≤60 days after diagnostic biopsy\u002Fsurgery\n5. No prior treatment for RMS other than surgery\n6. Medically fit to receive treatment\n7. Adequate hepatic function :\n\n   a. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert's syndrome\n8. Absolute neutrophil count ≥1.0x 109\u002FL (except in patients with documented bone marrow disease)\n9. Platelets ≥ 80 x 109\u002FL (except in patients with documented bone marrow disease)\n10. Fractional Shortening ≥ 28%\n11. Documented negative pregnancy test for female patients of childbearing potential\n12. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n13. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion\n\n1. Active \\> grade 2 diarrhoea\n2. Prior allo- or autologous Stem Cell Transplant\n3. Uncontrolled inter-current illness or active infection\n4. Pre-existing medical condition precluding treatment\n5. Urinary outflow obstruction that cannot be relieved prior to starting treatment\n6. Active inflammation of the urinary bladder (cystitis)\n7. Known hypersensitivity to any of the treatments or excipients\n8. Second malignancy\n9. Pregnant or breastfeeding women\n\nFrontline chemotherapy randomisation High Risk - CT1b Inclusion\n\n1. Entered in to the FaR-RMS study at diagnosis\n2. High Risk disease\n3. Age ≥ 6 months\n4. Available for randomisation ≤60 days after diagnostic biopsy\u002Fsurgery\n5. No prior treatment for RMS other than surgery\n6. Medically fit to receive treatment\n7. Adequate hepatic function :\n\n   a. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilbert's syndrome\n8. Absolute neutrophil count ≥1.0x 109\u002FL\n9. Platelets ≥ 80 x 109\u002FL\n10. Documented negative pregnancy test for female patients of childbearing potential\n11. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n12. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion\n\n1. Active \\> grade 2 diarrhoea\n2. Prior allo- or autologous Stem Cell Transplant\n3. Uncontrolled inter-current illness or active infection\n4. Pre-existing medical condition precluding treatment\n5. Urinary outflow obstruction that cannot be relieved prior to starting treatment\n6. Active inflammation of the urinary bladder (cystitis)\n7. Known hypersensitivity to any of the treatments or excipients\n8. Second malignancy\n9. Pregnant or breastfeeding women\n\nFrontline Radiotherapy Note: eligible patients may enter multiple radiotherapy randomisations.\n\nRadiotherapy Inclusion - for all radiotherapy randomisations\n\n1. Entered in to the FaR-RMS study (at diagnosis or prior to radiotherapy randomisation)\n2. Very High Risk, High Risk and Standard Risk disease\n3. ≥ 2 years of age\n4. Receiving frontline induction treatment as part of the FaR-RMS trial or with a IVA\u002FIVADo based chemotherapy regimen patients for whom. Note that patients for whom ifosfamide has been replaced with cyclophosphamide will be eligible\n5. Patient assessed as medically fit to receive the radiotherapy\n6. Documented negative pregnancy test for female patients of childbearing potential\n7. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n8. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nRadiotherapy Exclusion - for all radiotherapy randomisations\n\n1. Prior allo- or autologous Stem Cell Transplant\n2. Second malignancy\n3. Pregnant or breastfeeding women\n4. Receiving radiotherapy as brachytherapy\n\nRT1a Specific Inclusion\n\n1. Primary tumour deemed resectable (predicted R0\u002F R1 resection feasible) after 3 cycles of induction chemotherapy (6 cycles for metastatic disease)\n2. Adjuvant radiotherapy required in addition to surgical resection (local decision).\n3. Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic disease\n\nRT1b Specific Inclusion\n\n1. Primary tumour deemed resectable (predicted R0\u002FR1 resection) after 3 cycles of induction chemotherapy (6 cycles for metastatic disease).\n2. Adjuvant radiotherapy required in addition to surgical resection (local decision)\n3. Higher Local Failure Risk (HLFR) based on presence of either of the following criteria:\n\n   1. Unfavourable site\n   2. Age ≥ 18yrs\n4. Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic disease\n\nRT1c Specific Inclusion\n\n1. Primary radiotherapy indicated (local decision)\n2. Higher Local Failure Risk (HLFR) based on either of the following criteria:\n\n   1. Unfavourable site\n   2. Age ≥ 18yrs\n3. Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic disease\n\nRT2\n\n1. Available for randomisation after cycle 6 and before the start of cycle 9 of induction chemotherapy.\n2. Unfavourable metastatic disease, defined as Modified Oberlin Prognostic Score 2-4\n\n   * Note: Definition of metastatic lesions for RT2 eligibility\n\nModified Oberlin Prognostic Score (1 point for each adverse factor):\n\n* Age ≥10y\n* Extremity, Other, Unidentified Primary Site\n* Bone and\u002F or Bone Marrow involvement\n* ≥3 metastatic sites\n\nUnfavourable metastatic disease: 2- 4 adverse factors Favourable metastatic disease: 0-1 adverse factors\n\nMaintenance chemotherapy (Very High Risk) - CT2a Inclusion Randomisation must take place during the 12th cycle of maintenance chemotherapy.\n\n1. Entered in to the FaR-RMS study (at diagnosis or at any subsequent time point)\n2. Very High Risk disease\n3. Received frontline induction chemotherapy as part of the FaR-RMS trial or with a IVA\u002FIVADo based chemotherapy regimen\n\n   a. Patients for whom ifosfamide has been replaced with cyclophosphamide will be eligible\n4. Completed 11 cycles of VnC maintenance treatment (either oral or IV regimens)\n5. No evidence of progressive disease\n6. Absence of severe vincristine neuropathy - i.e requiring discontinuation of vincristine treatment)\n7. Medically fit to continue to receive treatment\n8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n9. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion\n\n1. Prior allo- or autologous Stem Cell Transplant\n2. Uncontrolled intercurrent illness or active infection\n3. Urinary outflow obstruction that cannot be relieved prior to starting treatment\n4. Active inflammation of the urinary bladder (cystitis)\n5. Second malignancy\n6. Pregnant or breastfeeding women\n\nMaintenance chemotherapy (High Risk) - CT2b Randomisation must take place during the 6th cycle of maintenance chemotherapy. Inclusion\n\n1. Entered in to the FaR-RMS study (at diagnosis or at any subsequent time point)\n2. High Risk disease\n3. Received frontline induction chemotherapy as part of the FaR-RMS trial or with a IVA based chemotherapy regimen. Note that patients for whom ifosfamide has been replaced with cyclophosphamide will be eligible\n4. Completed 5 cycles of VnC maintenance treatment\n5. No evidence of progressive disease\n6. Absence of severe vincristine neuropathy i.e. requiring discontinuation of vincristine treatment\n7. Medically fit to continue to receive treatment\n8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n9. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion\n\n1. Prior allo- or autologous Stem Cell Transplant\n2. Uncontrolled inter current illness or active infection\n3. Urinary outflow obstruction that cannot be relieved prior to starting treatment\n4. Active inflammation of the urinary bladder (cystitis)\n5. Second malignancy\n6. Pregnant or breastfeeding women\n\nCT3 Relapsed Chemotherapy\n\nInclusion:\n\n1. Entered in to the FaR-RMS study (at diagnosis or at any subsequent time point)\n2. First or subsequent relapse of histologically verified RMS\n3. Age ≥ 6 months\n4. Measurable or evaluable disease\n5. No cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous three weeks: within two weeks for vinorelbine and cyclophosphamide maintenance chemotherapy\n6. Medically fit to receive trial treatment\n7. Documented negative pregnancy test for female patients of childbearing potential within 7 days of planned randomisation\n8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active\n9. Written informed consent from the patient and\u002For the parent\u002Flegal guardian\n\nExclusion:\n\n1. Progression during frontline therapy without previous response (=Refractory to first line treatment)\n2. Prior regorafenib or temozolomide\n3. Active \\> grade 1 diarrhoea\n4. ALT or AST \\>3.0 x upper limit normal (ULN)\n5. Bilirubin, Total \\>1.5 x ULN; total bilirubin is allowed up to 3 x ULN if Gilbert's syndrome is documented\n6. Patients with unstable angina or new onset angina (within 3 months of planned date of randomisation), recent myocardial infarction (within 6 months of randomisation) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher Cardiac abnormalities such as congestive heart failure (Modified Ross Heart Failure Classification for Children = class 2) and cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted)\n7. Uncontrolled hypertension \\> 95th centile for age and gender\n8. Prior allo- or autologous Stem Cell Transplant\n9. Uncontrolled inter-current illness or active infection\n10. Pre-existing medical condition precluding treatment\n11. Known hypersensitivity to any of the treatments or excipients\n12. Second malignancy\n13. Pregnant or breastfeeding women",{"count":687,"type":22},1672,[325,25],"FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)",[691],"Rhabdomyosarcoma","2024-05-22",{"date":694,"type":37},"2024-05-23",{"date":696,"type":37},"2020-09-17",{"date":698,"type":22},"2030-06",{"name":43,"class":44},128,""]