[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Leeds Teaching Hospitals NHS Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":235},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,76,104,125,146,168,189,214],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100644629","brain-radiotherapy-imaging-for-high-grade-glioma-using-hypoxia-targeting-through-oxygen-enhanced-response-100644629",false,"NCT07670455","Brain Radiotherapy Imaging for High-grade Glioma Using Hypoxia Targeting Through Oxygen-Enhanced Response","BRIGHTER","Inclusion Criteria:\n\n* ≥18yrs.\n* Participants able to communicate with staff and safely comply with the study procedures.\n* Participants to provide informed written consent.\n\nExclusion Criteria:\n\n* Participants with any MRI contraindications including inability to lie flat in MRI scanner, claustrophobia and no foreign bodies, medical devices or other items which are considered an MRI contraindication.\n* Geographically remote patients unable to agree to imaging schedule.\n* Participants with illness or condition which means they cannot understand the requirements of the study.\n* Participants with cardiac or pulmonary disease that are unable to tolerate the flow of oxygen delivered via a mask.\n* Participants who have previously been treated with bleomycin (a chemotherapy used to treat some cancers including Hodgkin lymphoma and germ cell tumours).\n* Participants with contraindications to gadolinium-based contrast agent",true,"ALL","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","High-grade gliomas (HGGs) are the most common type of brain cancer in adults. Life expectancy for patients with HGGs is low. Radiotherapy aims to cure the tumour, but this is hard because HGGs are resistant to treatment. Among the possible causes of resistance may be tumour cells with low-oxygen levels (hypoxia). The investigators know that hypoxia reduces tumour sensitivity to radiotherapy. Using a special imaging technique called oxygen-enhanced MRI (OE-MRI), the investigators can try to identify areas of the tumour with hypoxia. The investigators could then give those areas a higher dose of radiotherapy. This might improve tumour control. This study aims to see if OE-MRI can find low-oxygen areas in HGGs. The study will also assess whether higher radiotherapy doses can be simulated in these regions.\n\nProject summary:\n\n1. Set up the OE-MRI process at Leeds Cancer Centre (LCC). OE-MRI settings will be tested on healthy volunteer participants to ensure the images are as good as possible.\n2. Participant Imaging. Patient participants with HGG will be recruited to take part. OE-MRI will be used to image participants during their treatment and track low-oxygen areas before treatment, halfway through treatment and 3 months after treatment has finished.\n3. Dose Escalation Assessment. Computer programs will be used to design radiotherapy treatments to test if higher radiation doses to the tumour's low-oxygen areas can better control the cancer. This will help understand if this targeted approach has potential benefits. This is modelling and will not alter routine clinical patient participant management.",[27,28,29,30],"High Grade Gliomas","Hypoxia Brain","Glioblastoma (GBM)","Brain Neoplasms, Adult",[32,33,34,35,36,37],"Oxygen-enhanced MRI","OE-MRI","Functional MRI","Hypoxia imaging","Quantitative MRI","Tumour hypoxia","NOT_YET_RECRUITING","2026-06-26",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":21},"2026-09-01",{"date":46,"type":21},"2028-10-31",{"name":48,"class":49},"The Leeds Teaching Hospitals NHS Trust","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100558951","redo-transcatheter-aortic-valve-implantation-for-the-management-of-transcatheter-aortic-valve-failure-100558951","NCT06557798","REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure","Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve","REVALVE","Inclusion Criteria:\n\n1\\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing",{"count":59,"type":21},550,"OBSERVATIONAL","Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.\n\nThe study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).\n\nThe study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.",[63],"Aortic Valve Stenosis",[65],"Bioprosthetic Valve Failure","RECRUITING","2026-06-22",{"date":69,"type":42},"2026-06-25",{"date":71,"type":42},"2024-12-12",{"date":73,"type":21},"2033-03",{"name":48,"class":49},71,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":84,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100601910","comparing-patient-reported-outcomes-and-clinical-outcomes-based-on-different-scar-placement-in-patients-undergoing-standard-breast-conserving-surgery-for-breast-cancer-the-prom-s-study-100601910","NCT07116642","Comparing Patient Reported Outcomes and Clinical Outcomes Based on Different Scar Placement in Patients Undergoing Standard Breast Conserving Surgery for Breast Cancer: The PROM-S Study.","Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)","PROM-S","Inclusion Criteria:\n\n* Female patients ≥18 years of age\n* Able to provide written informed consent\n* Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for sBCS (including multifocal cancers requiring x2 wires or magseeds)\n* Able to understand and complete the questionnaire\n\nScar over the lesion defined as radial, transverse, vertical, oblique scar over the tumour lesion location in the breast Remote incisions defined as lateral perimeter\u002Fperiareolar\u002Finfra-mammary fold\u002F benelli\u002Fhemi-batwing\n\n* No restrictions on tumour size (decision on suitability for sBCS will be based on clinical assessment)\n* Any axillary nodal staging status\n* Bilateral cancers allowed\n* Post neo-adjuvant chemotherapy (NACT) allowed\n\nExclusion Criteria:\n\n* Male patients (BCS not proven as standard of care) or transgender\n* Patients undergoing oBCS (such as wise pattern, vertical scar mastopexy incision pattern or volume replacement chest wall perforator flap)\n* Patients undergoing mastectomy with or without immediate autologous or implant reconstruction\n* Patients requiring nipple excision (central wide local excision)\n* Patients undergoing wide local excision under local anaesthetic\n* Women not able or willing to give informed consent\n* Where close tumour proximity to skin or skin involvement necessitates skin excision over the tumour\n* Patients diagnosed with locoregional recurrence\n* Patients diagnosed with associated distant metastasis\n* Patients undergoing diagnostic excision surgery for atypical breast lesions or benign lesions\n* Patients diagnosed with phyllodes lesion\n* Patients who have had previous ipsilateral breast surgery (any type)","FEMALE",{"count":86,"type":21},100,"This study is for patients with breast cancer and the objective is to compare patient reported outcome measures (PROMs) based on scar placement in patients undergoing standard breast-conserving surgery (sBCS). BCS has become the standard of care for eligible patients with breast cancer (current UK national BCS rate is 60%).\n\nScar placement for sBCS can be divided into two groups: those directly over the cancer, or those in remote locations (e.g. around the nipple, near the armpit, the lower part of the breast, where the breast and the chest meet etc.) with the aim of hiding the scar in more visually acceptable locations on the breast. Multiple factors determine where the scar is placed such as aesthetics, other health conditions, location of the cancer, etc. However, it is currently unclear whether the location of scar placement for sBCS affects patient reported outcomes.\n\nThe growing importance on breast cosmesis has led to more attention from clinicians and patients with regards to the selection of surgical incision placement for sBCS. By using a validated questionnaire (BREAST-Q), we wish to assess if there is any difference in PROMs based on scar placement (over the lesion vs. remote) in patients undergoing sBCS.\n\nIt is anticipated that the study results will help champion and guide care for future breast cancer patients, as well as providing an insight into how patient satisfaction may vary between different sBCS approaches.\n\nThis questionnaire study will include consecutive patients undergoing sBCS at Leeds Teaching Hospitals NHS Trust.\n\nParticipation in this non-randomised study will not impact on routine clinical care or decision making for the type of surgery planned or scar placement choice. Patients will be asked to complete the BREAST-Q questionnaire prior to surgery, after 2 weeks, as well as 3 and 12 months after surgery.",[89,90],"Breast Cancer - Female","Surgery of Breast Cancer",[92,93,94],"breast cancer","surgery","patient reported outcomes","2025-08-06",{"date":97,"type":42},"2025-08-11",{"date":99,"type":42},"2025-02-20",{"date":101,"type":21},"2027-06",{"name":48,"class":49},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":103},"100572283","virtual-ward-assisted-very-early-discharge-of-low-risk-stemi-patients-the-valiant-stemi-trial-100572283","NCT06731257","Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial","VALIANT-STEMI","Inclusion Criteria:\n\n* Successful revascularisation following STEMI\n* Zwolle score \\\u003C=3\n* No bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible)\n\nExclusion Criteria:\n\n* Haemodynamic instability (Killip class \\>I)\n* Left ventricular ejection fraction \\\u003C45%\\\u003C40%\n* Sustained ventricular or atrial arrhythmias requiring intervention\n* No support at home or social or physical circumstances preventing early discharge\n* Unable to use home monitoring equipment\n* Unwilling to consent or follow instructions\n* Patients visiting from out of our catchment area\n* Out-of hospital cardiac arrest\n* Patients repatriated to their local hospital within 24 hours\n* New or worsening renal failure (i.e. creatinine \\>=1.5x baseline)","99 Years",{"count":113,"type":21},600,[24],"Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service",[117],"Cardiovascular","2024-12-11",{"date":71,"type":42},{"date":121,"type":42},"2024-06-24",{"date":123,"type":21},"2026-03",{"name":48,"class":49},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":103},"100572106","assessing-nhs-implementation-of-an-online-resilience-training-acceptance-and-commitment-therapy-act-programme-to-prevent-job-loss-in-multiple-sclerosis-100572106","NCT06728956","Assessing NHS ImplemeNTation of an onlinE Resilience Training Acceptance and Commitment Therapy (ACT) Programme to Prevent Job Loss in Multiple Sclerosis","INTERACT-MS","Inclusion Criteria:\n\n* Participants capable of giving informed consent\n* Age 18 years or above\n* Currently in paid employment with an intention to remain in employment for at least 6 months\n* Phase 2: A registered healthcare professional or allied health professional who works in direct contact with patients diagnosed with Multiple Sclerosis OR\n* Phase 3: An individual with a clinical diagnosis of Multiple Sclerosis and reporting a WI score ≥11\u002F22 (on MS-WIS)\n\nExclusion Criteria:\n\n* Individuals lacking capacity to give informed consent\n* Individuals intending to leave paid employment within the next 6 months\n* Individuals who will not have access to a device used to access the internet (e.g.\n\nlaptop or smartphone) for the duration of study participation","66 Years",{"count":134,"type":21},300,[24],"People with MS (PwMS) are at increased risk of leaving work earlier than expected. Psychological factors that affect PwMS may make it more difficult to manage staying in work. These can include psychological flexibility and self efficacy. Psychological flexibility is the ability to effectively manage unwanted inner experiences (e.g., thoughts, memories, bodily sensations) in the present. Self-efficacy is the self-belief that an individual has in their ability to succeed.",[138],"Multiple Sclerosis","2024-12-06",{"date":118,"type":42},{"date":142,"type":42},"2024-06-14",{"date":144,"type":21},"2027-07-01",{"name":48,"class":49},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100563414","the-influence-of-concomitant-irritable-bowel-syndrome-on-gastro-oesophageal-reflux-disease-symptoms-and-severity-100563414","NCT06615856","The Influence of Concomitant Irritable Bowel Syndrome on Gastro-Oesophageal Reflux Disease Symptoms and Severity.","Understanding the Influence of Concomitant Irritable Bowel Syndrome (IBS) on Gastro-Oesophageal Reflux Disease (GORD), Including GORD-related Symptoms, GORD Severity, Oesophageal Motility, and Multi-Channel Intraluminal Impedance-pH Findings.","Inclusion Criteria:\n\n* Patients that have been referred for high-resolution oesophageal manometry and ambulatory pH or multichannel intraluminal impedance-pH (MII-pH) studies at the Gastrointestinal Physiology department at Leeds Teaching Hospitals NHS Trust from September 2024 to January 2025 (dates subject to change depending on acquisition of approvals).\n* All participants must be fully consenting with a good understanding of what the study involves.\n\nExclusion Criteria:\n\n* Patients aged \\<18 years.\n* Those that have not followed the pre-test preparation criteria, including: those that have not been sufficiently fasted prior to testing (6 hours for food, 3 hours for drinks); those that have not retained from taking proton pump inhibitor medication for 7 days prior to testing (lansoprazole, omeprazole, esomeprazole, rabeprazole, pantoprazole), histamine-2 receptor antagonist medication for 2 days prior to testing (famotidine, cimetidine, nizatidine), and other antacids on the day of testing (Gaviscon, Rennies, Peptac, etc).\n* Patients that lack the capacity to understand, retain, and communicate information to accurately complete questionnaires relating to their experienced symptoms.\n* Non-consenting patients.","90 Years",{"count":155,"type":21},124,"This research aims to investigate whether there is a link between irritable bowel syndrome (IBS) and acid reflux, particularly whether there is a difference in acid reflux symptoms between people with and without IBS.\n\nIBS is a functional gastrointestinal disorder, which has the same root cause as other functional gastrointestinal disorders that produce symptoms similar to acid reflux. Acid reflux symptoms may be typical (heartburn, regurgitation) or atypical (cough, sore throat, chest pain).\n\nAll participants are given two questionnaires: one to categorise them as either IBS or non-IBS, and one to understand their acid reflux symptoms. From this, the project will investigate whether there is a difference in the type (typical\u002Fatypical) and severity of acid reflux symptoms between people with and without IBS that attend for diagnostic acid reflux testing at Leeds Teaching Hospitals.\n\nTwo factors determine how much acid reflux someone has: the ability of the oesophagus (food- pipe) to move food from the throat to the stomach, and how well the muscle between the oesophagus and stomach works to keep acidic contents from moving back up.\n\nAll participants will have a test to see how well the muscles in their oesophagus are working. As there may be a link between IBS and oesophageal function, this project will investigate whether any patterns of abnormal oesophageal function can be identified in IBS patients that might explain their acid reflux symptoms.\n\nParticipants will then have a test that measures acid reflux over 24 hours, including the amount of acid and non-acid coming up, how high this reaches in the oesophagus, and whether symptoms are linked to these events.\n\nAnalysing these test results against questionnaire answers might help to understand the link between IBS and acid reflux to improve future diagnosis and treatment for the many people that have these conditions.",[158,159],"Irritable Bowel Syndrome","Gastro-oesophageal Reflux Disease","2024-09-24",{"date":162,"type":42},"2024-09-27",{"date":164,"type":21},"2024-10-14",{"date":166,"type":21},"2025-05",{"name":48,"class":49},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":103},"100557115","spinal-cord-stimulation-for-chronic-abdominal-pain-patients-100557115","NCT06533917","Spinal Cord Stimulation for Chronic Abdominal Pain Patients","Inclusion Criteria:\n\n1. Have been clinically diagnosed with CAP (from inguinal crease to T12 ribs), including diagnoses such as abdominal wall pain, chronic pancreatitis, gastroparesis, gastric dysmotility, irritable bowel syndrome, post-surgical or post-traumatic abdominal pain that is of visceral origin.\n2. Have been refractory to conservative therapy for a minimum of 3-months, including assessment of at least 2 different classes of medications and\u002For an anaesthetic block as clinically appropriate.\n3. Minimum baseline pain score of 5 on a VAS scale (0-10) for their visceral pain.\n4. Be 18 years of age or older at the time of enrolment.\n5. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.\n6. Be willing and capable of giving informed consent.\n7. Be willing and able to comply with study-related requirements, procedures, and visits.\n\nExclusion Criteria:\n\n1. Female participants of childbearing potential who are pregnant\u002Fnursing or plan to become pregnant during the trial.\n2. Escalating or changing pain condition within the past month as evidenced by investigator examination.\n3. Sphlanchnectomy or radiofrequency treatment within the past 6-months.\n4. Currently has an active or had an active implantable device including pacemakers, SCS or intrathecal drug delivery system.\n5. In the investigators opinion has an active infection.\n6. Participated in another clinical investigation within 30-days.\n7. Medical co-morbidities that preclude surgical intervention.\n8. Participant is incapable of understanding or responding to the study questionnaires.\n9. Participant is incapable of understanding or operating the patient programmer handset.\n10. Participant is morbidly obese (BMI ≥ 40 kg\u002Fm2).\n11. Participant has had a spinal surgical procedure or has spinal pathology that would significantly impede lead implantation at the level planned for implantation.\n12. Participant has another persistent painful condition other than persistent refractory visceral pain secondary to chronic abdominal pain.\n13. History of alcohol abuse in the last year or IV drug abuse in the last 3-years.\n14. No increases of more than 40% from baseline amylase.\n15. Have a condition currently requiring or likely to require the use of diathermy.","130 Years",{"count":176,"type":21},10,[24],"Chronic abdominal pain is a common disorder that can have significant impact on the lives of patients. Treatment options include medication which can have limited effectiveness, be associated with side effects and may lead to tolerance and dependency. Spinal cord stimulation (SCS) is a minimally invasive, therapeutic option for managing chronic abdominal pain. This involves implanting a device that delivers mild electrical signals to the spinal cord to reduce pain. Conventional SCS has been shown to improve abdominal pain caused by different disorders, but it causes feelings of unpleasant tingling in the tummy area. This feasibility study aims to explore relief from chronic abdominal pain symptoms when using a device that does not cause uncomfortable tingling feelings in the tummy area.",[180],"Pain","2024-08-13",{"date":183,"type":42},"2024-08-15",{"date":185,"type":42},"2024-01-18",{"date":187,"type":21},"2025-06-04",{"name":48,"class":49},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":103},"100524600","clinical-evaluation-of-a-computer-algorithm-to-report-breast-cancers-cleopatraa-100524600","NCT06110845","CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)","CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers","CLEOPATRAA","Inclusion Criteria:\n\n* all patients with a breast biopsy specimen processed at the pathology laboratory at SJUH, LTHT.\n\nExclusion Criteria:\n\n* Age \\\u003C16 or \\>110 years, non-carcinoma malignancies (e.g., sarcomas, malignant phyllodes tumours), carcinomas not arising from within the breast (e.g., cutaneous malignancies).","16 Years","110 Years",{"count":200,"type":21},800,"The goal of this non-interventionist observational study is to test the performance of a computer algorithm (QPORB) which examines breast cancer biopsy digital images to provide diagnostic support. The main question\\[s\\] it aims to answer are:\n\n1. The principal research aim is to determine whether 4D Path's Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly in the clinical environment (i.e. to define its real-life clinical utility) in terms of breast carcinoma grading and molecular subtyping\n2. The secondary research aim is to perform an economic analysis alongside the trial in order to establish the time, resource and cost savings that the technology could afford the NHS, the ideal price point for engaging with the technology and the cost:benefit ratio for evaluation by the National Institute for Clinical Excellence\n3. The tertiary research aim is to gather long-term follow-up data to better understand long-term response to therapy and prognosis and potential future uses of the algorithm\n\nParticipants's specimens will be tested alongside routine clinical workflows without intervention or consent. Researchers will compare the algorithm's results to those of routine diagnostic standard of care workflows.",[203],"Breast Cancer",[205],"Digital Pathology","2023-10-26",{"date":208,"type":42},"2023-11-01",{"date":210,"type":21},"2023-12-01",{"date":212,"type":21},"2034-11-30",{"name":48,"class":49},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":197,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":103},"100491257","british-axial-spondyloarthritis-inception-cohort-100491257","NCT05676775","British Axial Spondyloarthritis Inception Cohort","BAxSIC","Inclusion Criteria:\n\n1. Aged ≥16 years.\n2. A physician diagnosis of axSpA (including ankylosing spondylitis) within the last 6 months prior to baseline.\n3. Willing and able to give informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C16 years.\n2. Unable to communicate in English or are deemed, in any other way, to be unable to give informed consent","50 Years",{"count":223,"type":21},500,"The British Axial Spondyloarthritis Cohort (BAxSIC) study has been established under the auspices of the British Society for Spondyloarthritis (BRITSpA) in collaboration with the National Axial Spondyloarthritis Society (NASS) to provide real-world data to evaluate the impact of delay in diagnosis (from symptom onset to diagnosis) on work participation and functional outcomes and the natural history and impact of newly-diagnosed axial Spondyloarthritis, including disease activity, pain, fatigue, functional and work outcomes, comorbidities, therapies in the United Kingdom (UK). The study is a prospective cohort, enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy.\n\nThe study will run for an initial 3 year period commencing January 2023. Financial support was provided as a Research Grant from Pfizer Limited, UCB and Novartis.",[226],"Axial Spondyloarthritis","2023-07-14",{"date":229,"type":42},"2023-07-18",{"date":231,"type":42},"2023-06-09",{"date":233,"type":21},"2029-01-09",{"name":48,"class":49},""]