[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Cambridge\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":459},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,41,72,95,120,147,183,214,241,268,293,318,344,365,383,407,431],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637692","mngie-natural-history-study-100637692",false,"NCT07627217","MNGIE Natural History Study","A Retrospective Natural History Study of Subjects Affected by Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE)","Inclusion Criteria: All patients with a laboratory-confirmed TP deficiency:\n\n* any age or stage of disease; living or deceased\n* both previously published and unpublished patients\n* symptomatic and asymptomatic patients\n* TP deficiency defined by a and\u002For b and\u002For c:\n\n  1. Homozygous or compound heterozygous pathogenic or likely pathogenic mutations in the TYMP gene; and\u002For\n  2. Decreased TP enzyme activity \\\u003C20% of normal; and\u002For\n  3. Increased plasma dThd\\> 1 µmol\u002FL, or increased plasma dUrd \\> 5 µmol\u002FL.\n\nExclusion Criteria:\n\n* There are no formal exclusion criteria for this retrospective observational study.","ALL",{"count":18,"type":19},50,"ESTIMATED","OBSERVATIONAL","The MNGIE Retrospective Natural History Study is a collaborative study between the University of Cambridge and the University of Bologna. The aim of this study is to better understand the natural history and progression of Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE).\n\nNew treatment strategies for MNGIE, including gene therapies, enzyme replacement therapy, and other advanced treatments, are currently being developed and may soon be tested in clinical trials. A comprehensive and up-to-date natural history study of MNGIE is therefore very important to help inform the design of these clinical trials and to identify appropriate clinical and biochemical outcome measure.\n\nThis international natural history study aims to include as many patients with MNGIE (living or deceased) as possible, worldwide. This study will collect anonymised clinical information through a secure online REDcap database hosted at the University of Cambridge. Focus will be on describing clinical progression, and identifying biochemical, molecular, histological, and histochemical parameters that can help in early diagnosis, improve prognosis, and better understand therapeutic outcomes.\n\nThe study is funded by Pierrepont Therapeutics Inc, and has received ethical approval from the University of Cambridge Human Biology Research Ethics Committee. Clinicians caring for MNGIE patients, are invited to contact the study team, and will then receive a direct link to the survey. Patients are asked to share information about the study with their treating clinician, if they would like their (anonymous) clinical information to be included in the study.\n\nMore information and contact details are available online (https:\u002F\u002Fmitocamb.medschl.cam.ac.uk\u002Four-research\u002Fresearch-studies\u002Funderstanding-studies\u002Fa-retrospective-natural-history-study-of-subjects-affected-by-mitochondrial-neurogastrointestinal-encephalomyopathy-mngie\u002F).",[23,24],"MNGIE","Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE)",[26,27],"Natural History Study","Retrospective data collection","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-04","ACTUAL",{"date":34,"type":32},"2026-03-17",{"date":36,"type":19},"2027-07-31",{"name":38,"class":39},"University of Cambridge","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100619177","deep-brain-stimulation-to-understand-and-treat-addiction-100619177","NCT07341230","Deep Brain Stimulation to Understand and Treat Addiction","Deep Brain Stimulation for Disorders of Addiction: Mechanisms and a Pilot Blinded Randomized Cross-over Placebo Controlled Trial","Brain-PACER","Inclusion Criteria:\n\n* Adults aged 18 to 60 years\n* Diagnosed with Alcohol Use Disorder (AUD) according to DSM-5 criteria\n* Primary diagnosis of treatment-refractory AUD (comorbid nicotine dependence, other psychoactive substance use disorders, moderate major depressive disorder, anxiety disorders or obsessive-compulsive disorder are permissible if AUD is principal)\n* Disorder duration of AUD ≥ 5 years\n* At least 3 unsuccessful attempts at achieving abstinence\n* Failed prior psychotherapy and standard pharmacotherapy for AUD\n* Medically and neurologically suitable for surgery and MRI-compatible\n* Capable of providing informed consent and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Severe psychiatric disorder other than Alcohol Use Disorder (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)\n* Severe major depressive disorder (moderate depression acceptable)\n* Current active suicidal ideation or history of serious suicide attempts\n* Previous treatment with electroconvulsive therapy (ECT)\n* Presence of implanted electrical devices, including:\n* Cardiac pacemaker or defibrillator (or clinical indication for pacemaker placement)\n* Implanted vagus nerve stimulator (VNS)\n* Any other chronically implanted neurostimulation device\n* Significant neurological history, including prior hemorrhagic or ischemic stroke, subarachnoid hemorrhage, or other major neurological illness\n* Any significant medical condition that, in the opinion of the clinical team, would increase surgical or anesthetic risk\n* Current pregnancy\n* Contraindications to deep brain stimulation or neurosurgery, including:\n* Inability to tolerate general anesthesia (as assessed by anesthesiology)\n* Increased risk of bleeding (as determined by hepatology\u002Fhematology review)\n* History of coagulopathy\n* Current or previous anticoagulant use\n* Uncontrolled hypertension (controlled hypertension with medication is acceptable)\n* Stage 4 liver cirrhosis\n* History of major cardiac arrhythmia (e.g., atrial fibrillation) or need for anti-arrhythmic medication\n* History of requiring cardioversion\n* History of repeated falls\n* History of major head injury\n* Marked cognitive impairment\n* Seizure history, including multiple alcohol withdrawal seizures\n* Marked cortical atrophy on neuroimaging\n* Inadequate logistical or social support that would impair the safe conduct of deep brain stimulation therapy, including inability to reliably attend scheduled visits, lack of reasonable access to the study site, or inadequate home or caregiver support necessary for postoperative care, device management and follow-up.","18 Years","60 Years",{"count":52,"type":19},9,"INTERVENTIONAL",[55],"NA","This study is testing whether deep brain stimulation (DBS) can safely help people with severe alcohol use disorder who have not improved with standard treatments. DBS uses small electrical signals to change activity in brain areas linked to craving, self-control, and emotion. The study will test whether this treatment can reduce how often people drink and how much they drink each day. Researchers will also record brain activity to better understand how DBS affects craving and relapse.",[58],"Alcohol Use Disorder",[60,61,62],"Alcohol use disorder (AUD)","Deep brain stimulation (DBS)","Addiction","2026-03-22",{"date":65,"type":32},"2026-03-24",{"date":67,"type":32},"2025-07-01",{"date":69,"type":19},"2027-10-31",{"name":38,"class":39},2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100608398","ultrafast-whole-genome-sequencing-for-childhood-cancer-100608398","NCT07201038","Ultrafast Whole Genome Sequencing for Childhood Cancer","Feasibility of Ultrafast WGS in Paediatric Malignancies","UF-WGS","Inclusion Criteria:\n\n* Have given written informed consent to participate\n* Be aged \\\u003C25 years of age\n* Have confirmed or suspected malignancy\n* For pilot\u002Ffeasibility study (first 10 patients), only haematological malignancies (ALL\u002FAML) will be included\n* Have tumour and germline sample available - retrospectively collected or for prospective collection\n\nExclusion Criteria:\n\n* Inability to provide written informed consent (self or parent\u002Fguardian)\n* Insufficient tissue (BM\u002FPB\u002Ftissue) available for research purposes after collection for routine diagnostic purposes","0 Years","24 Years",{"count":18,"type":19},"Cambridge University Hospitals NHS Foundation Trust (CUHNFT) is the Principal Treatment Centre for the East of England region, responsible for 120-150 patients \\\u003C16 years with a new diagnosis of paediatric malignancy annually; leukaemia comprises \\~25% of these cases. Current molecular diagnosis of subgroups of childhood malignancies, particularly leukaemia, is based on flow cytometry, fluorescent in situ hybridisation (FISH) and single nucleotide polymorphim (SNP) arrays, for which the usual turnaround time (TAT) is 7-14 days. In the current era of access to targeted therapy, rapid diagnosis and treatment of patients in high-risk molecular subgroups is critical for improving outcomes. Children and adolescents with Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) have significantly improved survival when treated with tyrosine kinase inhibitors (TKIs). Patients with Ph+-like mutations (10- 20% of paediatric ALL), also have a poor prognosis, requiring escalation of treatment and addition of targeted therapy. Rapidly identifying MYCN amplification is also of critical prognostic importance in embryonal tumours of childhood including neuroblastoma (25%) and medulloblastoma, and directly impacts on treatment from the outset of the patient journey. Overnight whole genome sequencing (WGS) entails taking an additional 5ml Peripheral Blood (PB) and Bone Marrow (BM) samples after samples for routine diagnostic workup have been collected, and could replace current standard of care (SOC), which has a median turnaround time (TAT) of up to 28 days, and up to 84 days for specific gene mutations, which can delay appropriate prognostication and management of high-risk patients. Rapid, point of care information on somatic and germline mutations will allow early risk stratification and expedite treatment for high-risk patients with cancer.",[85],"Cancer Childhood",[87],"whole genome sequencing","2026-03-13",{"date":34,"type":32},{"date":91,"type":32},"2022-10-19",{"date":93,"type":19},"2028-10-17",{"name":38,"class":39},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":53,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100560611","closed-loop-in-adults-with-type-2-diabetes-100560611","NCT06579404","Closed-loop in Adults With Type 2 Diabetes","An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes","COYOTE","Inclusion Criteria:\n\n* Aged 18 years and older\n* Type 2 diabetes diagnosed for at least 12 months\n* Established on an SGLT2 inhibitor and\u002For GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.\n* Treatment with insulin therapy for at least 6 months\n* HbA1c ≤ 15% (140 mmol\u002Fmol) analysis from local laboratory or equivalent\n* Willing to wear study devices and follow study instructions\n* Capacity to consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current use of insulin pump\n* Current use of any closed-loop system\n* Any physical\u002Fpsychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician\n* Known or suspected allergy against insulin\n* Medically documented allergy towards the adhesive\n* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual impairment\n* Severe hearing impairment\n* Medically documented allergy towards the adhesive (glue) of plasters\n* Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor\n* Illicit drugs abuse\n* Prescription drugs abuse\n* Alcohol abuse",{"count":104,"type":19},224,[55],"The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes.\n\nThis is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices.\n\nThe primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol\u002FL) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \\& closed-loop usage, questionnaires and semi-structured interviews.",[108],"Type 2 Diabetes Treated With Insulin",[110,111],"Closed-loop insulin delivery","Type 2 diabetes","2026-03-10",{"date":88,"type":32},{"date":115,"type":32},"2024-12-06",{"date":117,"type":19},"2027-07",{"name":38,"class":39},12,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":53,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":40},"100560974","molecular-pituitary-imaging-using-18f-fet-pet-100560974","NCT06584123","Molecular Pituitary Imaging Using 18F-FET PET","Exploring the Potential for 18F-fluoro-ethyl-tyrosine (18F-FET) to Enable Wider Access to Molecular Imaging for Patients With Pituitary Adenomas (FET-pit-PET Study)","FET-pit-PET","Inclusion criteria\n\n* Participant is willing and able to give informed consent for participation in the study\n* Male or female, age 18 or above\n* Presence of pituitary adenoma suspected on the basis of clinical\u002Fbiochemical and\u002For radiological findings\n* Previous 11C-Met-PET\u002FCT\n\nExclusion criteria\n\n* Inability to give informed consent\n* Pregnancy or suspected pregnancy\n* Inability to lie supine for 30-60 minutes\n* Patient body habitus above scanner dimensions\n* Known allergy to intravenous radiographic contrast agents","100 Years",{"count":130,"type":19},20,[55],"The goal of this single centre pilot study is to explore whether 18F-fluoro-ethyl-tyrosine PET (FET-PET) yields comparable findings to 11C-methionine PET (Met-PET) for the localisation of pituitary tumours.",[134],"Pituitary Adenoma",[136,137,138],"Molecular pituitary imaging","Functional pituitary imaging","18F-FET PET","2026-01-05",{"date":141,"type":32},"2026-01-06",{"date":143,"type":32},"2024-09-03",{"date":145,"type":19},"2026-12-31",{"name":38,"class":39},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":16,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":53,"phases":160,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":40},"100606103","targeted-abdominal-ct-in-conjunction-with-lung-cancer-screening-100606103","NCT07171190","Targeted Abdominal CT in Conjunction With Lung Cancer Screening","Targeted Abdominal CT in Conjunction With Lung Cancer Screening - a Pilot Study (TACTICAL1): a Randomised Controlled Pilot Study of Adding Abdominal Non-contrast CT to Lung Cancer Screening CT Thorax Amongst High Lung Cancer Risk Ever-smokers Aged 55-70.","TACTICAL1","1. For the individual level randomisation to invitation control or invitation intervention\n\n   Inclusion criteria: To be randomised at the individual level to receive an invitation letter for LCS (standard of care; invitation control) versus invitation letter for LCS with potential for an additional abdominal scan (invitation intervention):\n   * Be eligible to be invited to the first round of a West Yorkshire and Harrogate LCS or a Humber and North Yorkshire Cancer Alliance LCS (i.e. have been identified as a smoker or ex-smoker and registered as living within the relevant LCS catchment area).\n   * Be registered with a GP in England.\n   * Be aged 55-70 years 364 days old at the date of invitation.\n\n   Exclusion criteria\n\n   • None\n2. Eligibility criteria for the cluster level randomisation to scan intervention or scan control\n\n   Inclusion criteria a): To be eligible for the cluster level randomisation the participant must:\n   * Have been individually randomised to the invitation intervention arm\n   * Have booked in for a LCS assessment\n\n   Inclusion criteria b): To receive the CT Thorax plus ANCCT, the participant must:\n   * Have been randomised to the scan intervention cluster\n   * Be invited to attend for a LDCT Thorax based upon scores on either PLCOM2012 or Liverpool Lung Project (LLP) risk prediction models (PLCOM2012 risk of ≥1.51% over six years or LLPver2 five-year risk of ≥2.5%)14 during the LCS assessment.\n   * Have attended the lung scan appointment\n   * Have given electronic or written informed consent to participate\n\n   Exclusion criteria\n\n   Existing LCS exclusion criteria:\n   * Participant does not have capacity to give consent (standard criteria for assessing capacity apply).\n   * Weight or physical size exceeds restrictions for scanner (\\>200kg).\n   * Participant unable to lie flat.\n   * Poor physical fitness such that treatment with curative intent would be contra-indicated.\n   * Participants who have had a full CT Thorax that meets the image reconstruction parameters of the programme in the last 12 months are not excluded from the lung screening programme, but would have their CT Thorax appointment deferred until 12 months have elapsed since that last scan, provided they still meet all inclusion criteria and have no exclusion criteria - if the deferred appointment is within the timeframe for TACTICAL1, they remain eligible but if deferred appointment is outside the timeframe for TACTICAL1 they would not be eligible.\n\n   Additional TACTICAL1 exclusion criteria:\n\n   • Had an abdominal CT in the previous 12 months or has one booked within the next 3 months.\n   * For HNY, this is checked before the LCS assessment. Therefore, participants will be excluded before the LCS assessment.\n   * For WYH, this is only checked after the LCS assessment. Therefore, anyone having had an abdominal CT in the previous 12 months or with one booked within the next 3 months will be excluded at this point (see 8.6).\n3. Eligibility criteria for the process evaluation Health care professionals: Healthcare professionals involved in the delivery of LCS in any of the study areas who agree to take part.\n\nParticipants: People individually randomised to the invitation intervention arm who attend the LCS assessment or the scanning unit within the study period and who agree to be interviewed.",true,"55 Years","70 Years",{"count":159,"type":19},6272,[55],"Early detection through screening can improve cancer survival by identifying it when it's most treatable. The NHS now offers Lung Cancer Screening (LCS) assessments to people aged 55-74 who have ever smoked. Those at higher risk of lung cancer are offered a lung scan.\n\nThis group also has a high risk of developing abdominal cancers, such as kidney cancer. A recent study explored whether it would be feasible to extend the lung scan to include the abdomen. Results showed most participants supported this addition, and the number of serious findings was similar to those detected in UK breast or bowel cancer screening programmes.\n\nHowever, the abdominal scan was only offered on the day of the lung scan, giving little time for people to consider their decision. The process also added too much time to be practical for widespread implementation.\n\nThis new study will:\n\n* Test whether mentioning the possible abdominal scan in the initial LCS invitation affects participation in LCS assessments.\n* Test new processes to assess if the abdominal scan can be added to the lung scan with minimal extra time.\n* Check if participants can be split between the lung scan only group and lung and abdominal scan group using an approach called 'cluster randomisation'. This will be important in case a bigger trial is needed.\n* See whether the additional processes are acceptable\n\nPeople aged 55-70 who are invited to the lung cancer screening will be eligible to take part in this study. Only those who are found to be at a high risk of lung cancer after their assessment, and therefore offered a lung scan, will be offered the abdominal scan, provided they have not had an abdominal scan in the previous 12 months or one booked in the next 3 months.\n\nThis study will take place in two existing lung cancer screening locations in Yorkshire.",[163,164,165,166],"Renal Cell Carcinoma (Kidney Cancer)","Kidney Cancers","AAA - Abdominal Aortic Aneurysm","Renal Stones",[168,169,170,171,172,173,174],"Screening","NHS Lung Cancer Screening","Kidney cancer","Abdominal cancer","Lung cancer","Abdominal Aortic Aneurysms (AAA)","Abdominal screening","2025-12-12",{"date":177,"type":32},"2025-12-19",{"date":179,"type":32},"2025-11-11",{"date":181,"type":19},"2027-10",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100603088","transcriptional-analysis-of-mechanisms-in-liver-failure-and-sepsis-100603088","NCT07131969","Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis","Transcriptional Analysis of Mechanisms and Predictors in Acute Liver Failure and Sepsis","MAP-ALF","Inclusion Criteria:\n\n* acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU\n* all cause sepsis admitted to ICU\n\nExclusion Criteria:\n\n* age \\\u003C16y",{"count":192,"type":19},100,"Context Acute liver failure (ALF) is a life-threatening condition that occurs on the background of a healthy liver. The most common cause of acute liver failure in the UK is paracetamol overdose. Acute liver failure results from liver damage and activation of the body's inflammatory defences with subsequent damage to other organs including kidneys, lungs and heart. This often requires life support in an intensive care unit before liver transplantation (LT), the only currently available and effective rescue treatment for acute liver failure.\n\nChallenge Patient factors and organ availability limit who can benefit from liver transplant. At present there are no effective alternative therapies for patients who do not get a liver transplant, and survival rates in these situations are poor. The underlying mechanisms of inflammation are poorly understood, thus therapies are limited.\n\nAim The investigators research aims to understand the mechanisms that underpin the inflammation seen in acute liver failure by studying the inflammatory cells in the blood and examining their cellular programmes. This will allow the investigators to identify pathways that are activated and understand how the liver and blood interact to spread inflammation around the body. The investigators aim to identify targets for disease-modifying therapies to avert the need for liver transplant.\n\nImportance Understanding how the body responds to acute liver failure, and whether there are different patterns of inflammatory response, will enable trials of immune-modulating drugs to prevent the need for liver transplantation or prolong the time a patient can wait for an organ. This has the potential to help improve organ availability for other patients and save lives in acute liver failure.",[195,196],"Acute Liver Failure","Sepsis",[198,199,200,201,202,203],"acute liver failure","sepsis","transcriptional analysis","predictors","paracetamol overdose","acetaminophen overdose","NOT_YET_RECRUITING","2025-08-19",{"date":207,"type":32},"2025-08-26",{"date":209,"type":19},"2025-09",{"date":211,"type":19},"2028-09",{"name":38,"class":39},7,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":40},"100594992","pre-clinical-diagnosis-using-integrated-microbial-and-host-response-signatures-to-improve-outcomes-from-ventilator-associated-pneumonia-in-critically-ill-children-100594992","NCT07026656","Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children","VAP-Dx","Inclusion Criteria:\n\n* PICU Admission\n* Requires 48 Hours Of Mechanical Ventilation\n\nExclusion Criteria:\n\n* Imminent death or palliative care pathway planned\n* Existing tracheostomy at time of admission\n* Known immunocompromised patient\n* Patient received a full course of systemic antimicrobials in the previous 6 weeks.\n* Known or suspected tuberculosis (TB).","1 Month","16 Years",{"count":224,"type":19},300,"Ventilator-associated pneumonia (VAP), defined as pneumonia occurring 48 hours after initiation of invasive mechanical ventilation, is insidious in onset and severe in consequence. It is a critical issue affecting 10-20% of the 26,000 children admitted to the paediatric intensive care unit (PICU) each year. Infection typically leads to extended PICU stay, prolonged invasive mechanical ventilation, and increased mortality.\n\nDespite its clinical significance, VAP remains poorly defined, as current diagnosis relies on non-specific criteria and the ability to obtain clinically meaningful cultures. VAP, deviates from conventional pneumonia, potentially originating, from tissue damage, changes to immune processes, and migration of gastrointestinal bacteria into the lung; all associated with prolonged mechanical ventilation. These factors, in combination with the clinical instability of PICU patients, mean that clinicians aggressively start antibiotic therapy despite a paucity of evidence to suggest the best regime. As a result, suspected VAP has been shown to account for nearly 40% of antibiotic exposure in the PICU, which has significant implications on anti-microbial resistance (AMR).\n\nTo address these challenges, novel diagnostic therapies are needed to optimise the treatment of VAP. These therapies should utilise our current understanding of the pathophysiology of VAP development, specifically, the infiltration of the lung microbiome by gut and oral bacteria during prolonged mechanical ventilation. To achieve this, molecular testing should be promoted allowing for rapid identification of lung pathogens. There is also growing evidence, for the investigation of predictive biomarkers for VAP available in both the blood and lungs, which when integrated into protocols may enhance diagnostic accuracy. These novel techniques may improve clinical outcomes for affected children while addressing the economic impact of prolonged hospital stays and mitigating AMR risks in PICUs.",[227],"Ventilator Associated Pneumonia ( VAP)",[229,230,231,232],"Respiratory Tract Infection","Immunology","Genomics","Paediatric Intensive Care Unit (PICU)","2025-07-30",{"date":235,"type":32},"2025-08-03",{"date":237,"type":32},"2025-04-14",{"date":239,"type":19},"2027-09-30",{"name":38,"class":39},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100601109","evaluating-near-infrared-spectroscopy-devices-for-monitoring-traumatic-brain-injury-100601109","NCT07106216","Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury","Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.","NIRS in TBI","Inclusion Criteria:\n\nThose in the Neuro Critical Care Unit at Addenbrooke's (Cambridge, UK) AND\n\nPatients with moderate or severe head trauma AND\n\nOver 18 AND\n\nThose with intracranial pressure monitoring probes.\"\n\nExclusion Criteria:\n\nWe will not monitor anyone aged under 18 OR\n\nWe will not monitor anyone with penetrating wounds in the area we want to monitor OR\n\nPatients who are enrolled on \\>2 other research studies, as per local guidelines OR\n\nMoribund at presentation OR\n\nThose with infectious diseases.",{"count":250,"type":19},10,"This project seeks to evaluate the capabilities of new Near Infrared Spectroscopy (NIRS) devices, which use light to measure brain activity, for monitoring how the brain and body react after a serious head injury (TBI), particularly in the immediate and shortly following periods. Data recorded from these devices will help determine if they can effectively monitor additional complications and outcomes in adults over 18 with severe TBIs in a specialised intensive care unit for brain injuries (NCCU) at Addenbrooke's Hospital (Cambridge, UK). We will use two different NIRS devices similar to those currently used in the NCCU but with extra improvements. Both devices are proven to be safe and do not require surgery or internal procedures.\n\nParticipants will be recruited based on several criteria and monitored early in their NCCU admission. Monitoring will be daily for 6 hours, lasting from half a week to two weeks, depending on recovery progress. After the initial 10 patients, we will perform an interim analysis and may adjust the recording duration. We aim to recruit a maximum of 50 participants in total. Due to their condition, participants will not be able to give permission to participate, so we will seek it from their next of kin within 24 hours of admission. The study will only observe and not influence treatment. We will also collect additional clinical data, such as scans, the patient's condition six months after the injury, and other medical information for analysis.\n\nThe data collection period for this study will last up to 2 years. We will remove any personal details from the patient data. The body function data, with personal details removed, will be transferred and stored on the Brain Physics Lab server (segregated) and University of Cambridge computers for analysis. Any data not saved in dedicated long-term storage will be deleted after use.",[253],"Tramatic Brain Injury",[255,256,257,258,259],"brain","head","injury","severe","nirs","2025-07-29",{"date":262,"type":32},"2025-08-06",{"date":264,"type":19},"2025-08-01",{"date":266,"type":19},"2026-09-30",{"name":38,"class":39},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":155,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":278,"conditions":279,"keywords":283,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":40},"100474610","optical-neuroimaging-and-cognition-100474610","NCT05460143","Optical Neuroimaging and Cognition","Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia","ONAC","Inclusion Criteria:\n\n1. A diagnosis of probable:\n\n   * Lewy Body Dementia\n   * Alzheimer's Disease\n   * Mild Cognitive Impairment (MCI-LB or MCI-AD) OR\n2. Cognitively normal for their education and age, with a MMSE score above 26 AND\n\n   * A good grasp of the English language\n   * An informant (either a carer or family member) who will be available throughout testing (only relevant if in a patient group)\n\nExclusion Criteria:\n\n1. Severe dementia\n\n   * Unable to participate\n   * A MMSE score below 12\n2. A condition which influences metabolism or haemodynamics\n\n   * Such as metabolic or respiratory disorders\n3. A significant mental illness\n\n   * Such as rheumatoid arthritis, systemic lupus erythematosus\n   * Oral steroid use\n4. A significant psychiatric disorder\n5. MCI due to other causes such as traumatic brain injury, vascular dementia, or fronto-temporal dementia\n6. A history of excessive drug or alcohol use\n7. Contraindications to MRI (only for patient groups undertaking the MRI scan: AD\u002FMCI\u002FDLB)\n\n   * Surgical implants e.g. pacemakers\n   * Obesity",{"count":277,"type":19},200,"Dementia is associated with a variety of neurovascular and neurometabolic abnormalities. Traditional imaging techniques used to investigate such abnormalities, such as Positron Emission Tomography and functional Magnetic Resonance Imaging, are not always well tolerated, have expensive start up and running costs, and are limited with regards to the types of experiments that can be performed as they can be highly sensitive to movement, are noisy, and have physical restrictions.\n\nNear-infrared spectroscopy (NIRS) is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to detect relative changes in concentration of oxygenated and deoxygenated haemoglobin, and the oxidation state of Cytochrome C Oxidase. As such, NIRS can provide measures of brain oxygenation and metabolism. NIRS is less sensitive to movement, is well tolerated and has few contraindications. It is thus a promising candidate for use in clinics or in peoples' homes for monitoring dementia.\n\nIn the present study, the investigators aim to use both dual-wavelength and broadband NIRS in a range of dementia subtypes, including Alzheimer's Disease and Dementia with Lewy Bodies, and severities, including Mild Cognitive Impairment, to identify how brain oxygenation and metabolism is altered in dementia and across various clinical subgroups. The investigators also aim to determine the relationship between brain oxygenation and metabolism in dementia, and use machine learning approaches to identify optical biomarkers for dementia.",[280,281,282],"Dementia With Lewy Bodies","Alzheimer Disease","Mild Cognitive Impairment",[284],"Dementia","2025-04-07",{"date":287,"type":32},"2025-04-10",{"date":289,"type":32},"2023-05-01",{"date":291,"type":19},"2025-09-01",{"name":38,"class":39},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":53,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":40},"100580994","targeting-beta-cell-function-to-achieve-remission-of-type-2-diabetes-100580994","NCT06844539","taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs","Targeting Beta-cell Function to Achieve Remission of Type 2 Diabetes (REACTIVATE). An Open-label, Single-centre, Randomised, Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Achieving Remission of Diabetes Compared to Standard Therapy With a Glucose Sensor in Adults With Recent Onset Type 2 Diabetes","REACTIVATE","Inclusion Criteria:\n\n* Aged 18 years and older\n* Type 2 diabetes diagnosed \\>6 months and ≤5 years ago\n* Treatment with glucose lowering medication for at least 3 months\n* HbA1c \\>48 mmol\u002Fmol on analysis from local laboratory or equivalent\n* Willing to wear study devices and follow study instructions\n* Capacity to consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Current use of insulin pump\n* Current use of any closed-loop system\n* Any physical\u002Fpsychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician\n* Known or suspected allergy against insulin\n* Pregnancy, planned pregnancy, or breast feeding\n* Severe visual or hearing impairment\n* Medically documented allergy towards the adhesive of plasters\n* Serious skin diseases located at places of the body potentially used for localisation of the glucose sensor\n* Drug or alcohol misuse\n* Group 2 driving licence holder",{"count":302,"type":19},56,[55],"The main objective of the REACTIVATE study is to investigate whether a period of intensive insulin therapy using closed-loop technology, when combined with diet and lifestyle education, can restore beta-cell function and achieve remission of recent-onset type 2 diabetes.\n\nThis is a single-centre, open-label, randomised, parallel design study comparing up to 12 weeks of fully closed-loop insulin delivery to standard care with a glucose sensor in adults with recent-onset type 2 diabetes. The primary outcome is the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c below 48mmol\u002Fmol after 12 or more weeks off all diabetes medications.\n\nOther key outcomes include area under the curve for C-peptide and glucose during mixed meal tolerance test, the proportion of time spent with glucose levels within and above the target glucose range and mean sensor glucose as recorded by glucose sensor at 52 weeks.\n\nSafety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Utility and human factors outcomes include glucose sensor and closed-loop usage, questionnaires and semi-structured interviews.",[306],"Type 2 Diabetes",[308,309],"Remission","closed-loop","2025-03-27",{"date":312,"type":32},"2025-03-28",{"date":314,"type":19},"2025-04-24",{"date":316,"type":19},"2029-04-30",{"name":38,"class":39},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":4},"100572321","the-planetary-outcomes-after-intracranial-haemorrhage-study-100572321","NCT06731751","The Planetary Outcomes After Intracranial Haemorrhage Study","A Prospective, International Observational Study Assessing the Global Variation in Patient Characteristics, Management and Outcomes of Spontaneous Intracranial Haemorrhage.","PLOT-ICH","Inclusion Criteria:\n\n* Patients of any age with the presence of spontaneous intracranial haemorrhage (parenchymal, intraventricular and \u002F or subarachnoid haemorrhage) on intracranial imaging (and absence of a history of trauma).\n\nAND:\n\n• Admission to hospital for sICH management. This includes admission for observation, conservative or interventional management to both ward-based and critical care settings.\n\nExclusion Criteria:\n\n* Patients who have a clear history of trauma as the primary cause of the haemorrhage and therefore are diagnosed with traumatic intracranial haemorrhage.\n* Patients with subdural or extradural haematomas but no clear history of trauma.\n* Patients with intracranial haemorrhage occurring as a complication of a procedure or intervention (e.g. post-operative haematoma) or iatrogenic (e.g. after thrombolysis for ischaemic stroke).\n* Patients who undergo elective (planned admission to hospital) or semi-elective (where a patient was initially admitted to hospital, then discharged from hospital and re-admitted for surgery) procedures.\n* Patients re-admitted to hospital within 30 days of the initial admission with sICH (including those re-admitted for acute management of sICH-related complications).\n* Patient presenting to the emergency department (ED) but discharged home from the ED immediately without a period of observation or admission to a ward.",{"count":327,"type":19},1000,"Over twelve million strokes occur worldwide every year, and stroke is the second most common cause of death globally. Strokes happen because blood supply to the brain is damaged. This can be due to a blockage (ischaemic stroke) or a bleed (haemorrhagic stroke - or intracranial haemorrhage). Intracranial haemorrhage can be life-threatening and patients with this type of stroke can be very sick, requiring urgent medical care including medications, close monitoring, and sometimes surgery.\n\nStrokes happen worldwide, but over 80% of stroke cases and associated death and disability occur in low- and middle- income countries (LMICs), where resources to manage them can be limited. However, the differences in how patients present, the hospital care they receive, and their overall outcomes when compared to high-income countries (HICs) patients are not fully understood. There are many stroke-related deaths occurring each year around the world, especially among those who have presented with an intracranial haemorrhage, and if survival rates are to be improved, high-quality data is needed to help us better understand where the improvements in care are required in different health settings.\n\nRun and funded by the University of Cambridge, this study will collect data on all patients across all ages during a one-month period who undergo treatment for spontaneous intracranial haemorrhage, both medical and surgical. We will include patients from any hospital across the world that treats patients with this condition, collecting data from their admission to hospital until their discharge, death or up to 30 days from their presentation.\n\nThis is an observational study, so we are only observing patients care and management, not making any direct changes to their treatment. We will also be asking each centre to complete a written survey, to better understand some of the more complex areas which are important for the care of intracranial haemorrhage patients such as hospital resources available, and the potential barriers they face in accessing appropriate healthcare.",[330,331,332],"Stroke","Intracerebral Haemorrhage","Subarachnoid Haemorrhage (SAH)",[334,335,336],"brain haemorrhage","intracerebral haemorrhage","subarachnoid haemorrhage","2024-12-09",{"date":339,"type":32},"2024-12-12",{"date":341,"type":19},"2025-01-01",{"date":145,"type":19},{"name":38,"class":39},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":53,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":40},"100517325","investigation-of-differential-biology-of-benign-and-malignant-renal-masses-using-advanced-magnetic-resonance-imaging-techniques-100517325","NCT06016075","Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques","IBM-Renal","Inclusion Criteria:\n\n* Over 18 years old\n* Able to and provide written informed consent to participate\n* If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception\n* If male, using a suitable contraceptive method for the duration of the study\n* Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice\n* Capable of undergoing a minimum of one study visit\n\nExclusion Criteria:\n\n* Contraindication or inability to tolerate MRI\n* Pregnant or actively breast-feeding woman\n* If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)\n* Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators\n* Laboratory abnormalities that may impact on the study results\n* Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators",{"count":352,"type":19},30,[55],"The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.",[356],"Kidney Cancer","2024-12-03",{"date":359,"type":32},"2024-12-05",{"date":361,"type":32},"2023-01-01",{"date":363,"type":19},"2026-01-01",{"name":38,"class":39},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":40},"100533528","molecular-imaging-in-fabry-disease-of-the-heart-100533528","NCT06226987","Molecular Imaging in Fabry Disease of the Heart","Inclusion Criteria:\n\n* Male or female participants \\>18 years old\n* Able to give written, informed consent and to lie flat\n* Have Fabry disease based on molecular diagnosis (at a minimum, documented enzyme deficiency in males and documented pathogenic mutation in females)\n* Cardiac MRI within 3 years documenting cardiac involvement in Fabry disease (left ventricular hypertrophy and\u002For late gadolinium enhancement and\u002For myocardial oedema)\n\nExclusion Criteria:\n\n* Any other diagnosis associated with cardiac muscle inflammation, including myocarditis\n* Previous gene therapy\n* Contra-indication to MRI scanning or intravenous gadolinium contrast (prior contrast reaction or chronic kidney disease with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Women of child bearing potential not using adequate contraception\n* Uncontrolled atrial fibrillation\n* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study",{"count":119,"type":19},"Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, the investigators will test the use of 68Ga-DOTATATE PET\u002FMRI for identifying myocardial inflammation in patients with Fabry disease.",[374],"Fabry Disease, Cardiac Variant","2024-07-18",{"date":377,"type":32},"2024-07-22",{"date":379,"type":32},"2024-01-02",{"date":381,"type":19},"2026-01-02",{"name":38,"class":39},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":53,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":40},"100368168","pet-imaging-of-inflammation-and-lipid-lowering-study-100368168","NCT04073797","PET Imaging of Inflammation and Lipid Lowering Study","PIILL","Inclusion Criteria:\n\n* Male or female participants \\>18 years old\n* Able to give written, informed consent and to lie flat\n* Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and\n* History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and\n* Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and\n* Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound\n\nExclusion Criteria:\n\n* Women of childbearing potential not using adequate contraception\n* Contra-indication to MRI scanning\n* Statin-associated myositis or liver function abnormality\n* Already taking inclisiran or colchicine\n* Sensitivity and\u002For contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood disorders, and patients with renal or hepatic impairment who are taking a P-gp inhibitor or a strong CYP3A4 inhibitor\n* Contrast allergy or contrast-nephropathy\n* Chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Cardiovascular event within 6 months\n* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study\n* Uncontrolled chronic inflammatory disorder\n* History of recent malignancy deemed relevant to the study by the investigator\n* Treatment with medications that result in significant drug to drug interactions with the study medications\n* Current use of systemic corticosteroids or other immunosuppressive drugs\n* Previous or planned carotid endarterectomy surgery or stenting on the index side","99 Years",{"count":392,"type":19},63,[55],"While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.",[396,397,398,399],"Hypercholesterolemia","Hypercholesterolemia, Familial","Atherosclerosis","Carotid Artery Plaque",{"date":401,"type":32},"2024-07-19",{"date":403,"type":32},"2023-03-20",{"date":405,"type":19},"2026-03-01",{"name":38,"class":39},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":155,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":40},"100524763","neurobehavioural-and-cognitive-changes-in-cancer-cachexia-cancog-100524763","NCT06112964","Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)","Understanding the Impact on CANcer on Neurobehavioral Mechanisms and COGnition in Cachexia (CANCOG)","CANCOG","Inclusion Criteria:\n\nGeneral inclusion criteria for all groups:\n\n* Written informed consent\n* Aged 18 years or over\n* Willing and able to comply with study procedures and visits\n\nAdditional inclusion criteria for participants with cancer:\n\n* Histological or cytological diagnosis of cancer or confirmed non-intracranial malignancy on imaging.\n* Unintended documented weight loss of \\>5% body weight in 6 months which is felt to be cancer related, OR patient reported weight loss and\u002For change in appetite\n\nExclusion Criteria:\n\nGeneral exclusion criteria for all groups:\n\n* Non-fluent English speaker\n* Active infection, as determined by the investigator based on clinical symptoms and \u002F or fever and \u002F or requirement for antibiotics\n* Women, who are pregnant, plan to become pregnant or are lactating.\n* MRI contraindication\n* A significant acute, chronic or psychiatric condition which in the judgement of the investigator would place the volunteer at undue risk or interfere with the study\n* Metabolically or clinically unstable on day of study visit\n* Artificial nutrition\n* Taking medications which, as determined by the investigator, may affect appetite or cognition, or otherwise affect completion of study tasks.\n* Weight or body circumference above upper threshold for MRI scanner (220kg)\n* Unresolved obstructive gastrointestinal (GI) lesion\n\nAdditional exclusion criteria for participants with cancer:\n\n• Intracranial cancer or metastatic intracranial involvement of cancer\n\nAdditional exclusion criteria for healthy volunteers:\n\n* Have, or be recovering from, any form of cancer\n* Unintentional weight loss of \\>5% body weight or unexplained loss of appetite",{"count":18,"type":19},"The goal of this observational study is to to look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. The main questions it aims to answer are:\n\n1. Are there differences in areas of the brain known to be related to appetite control, food reward and motivation, between participants with cancer related weight loss and healthy volunteers\n2. Do responses to questionnaires and computer based tasks suggest participants with cancer related weight loss have reduced appetite and reduced motivation to eat compared to healthy volunteers, and if so, do questionnaires suggest that this is associated with any other symptoms?\n\nResearchers will compare the structure and blood flow in relevant areas of the brain using MRI images between participants with cancer related weight loss and healthy volunteers. Participants will complete questionnaires and computer based tasks to allow researchers to assess areas of the brain which become more active in response to different stimuli. Some computer based tasks will be performed during the MRI scan. This is called functional MRI.\n\nA further objective is to obtain an archive of blood samples which will be stored securely for future analysis if relevant hormones or analytes are identified that may be relevant to metabolism or body composition",[418,419,420,421,422],"Cancer","Cachexia","Cachexia-Anorexia Syndrome","Appetite Loss","Weight Loss","2024-07-16",{"date":425,"type":32},"2024-07-17",{"date":427,"type":32},"2024-02-15",{"date":429,"type":19},"2027-11",{"name":38,"class":39},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":438,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":71},"100496591","inflammation-and-small-vessel-disease-study-100496591","NCT05746221","INflammation and Small Vessel Disease Study","INSVD","Inclusion Criteria:\n\n* Have given written informed consent to participate\n* Be aged 40 years and over\n* Have symptomatic cerebral small vessel disease (SVD) defined as:\n* Clinical lacunar stroke syndrome with lacunar infarct, as defined by the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria\n* And\u002FOR Symptoms of cognitive impairment due to SVD with lacunar infarct on MRI\n* And\u002FOR Gait apraxia\u002Fmotor impairment presumed due to SVD with lacunar infarct on MRI\n\nExclusion Criteria:\n\n* Unable\u002Funwilling to consent including lack of capacity to consent\n* Contraindications to taking part in MRI study as assessed by the local MRI safety questionnaire, e.g., pacemaker\n* Vaccination or infection with fever in preceding month\n* Any stroke cause other than SVD including:\n* Cardioembolic source\n* Carotid or vertebral stenosis \\> 50% measured on NASCET (North American Symptomatic Carotid Endarterectomy Trial) criteria\n* Myocardial infarction in past year\n* Auto-immune\u002Fauto-inflammatory disease\n* Use of immunomodulating drugs\n* Estimated glomerular filtration rate (eGFR) =\\\u003C59 ml\u002Fmin\u002F1.73m2 within past 3 months for Cambridge, and eGFR =\\\u003C29 ml\u002Fmin\u002F1.73m2 within past 3 months for Nijmegen, in line with local guidelines. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation: 186 x (Creatinine \u002F 88.4)-1.154 x (Age)- 0.203 x (0.742 if female) x (1.210 if black). Creatinine will be checked within 3 months of the MRI, and if this has not been done as part of clinical care it will be performed as a research procedure.\n* Another diagnosed chronic neurological condition (e.g. Alzheimer's, Parkinson's disease, motor neurone disease, multiple sclerosis).\n* Limited life expectancy due to another illness or chronic condition making the 2-year follow-up difficult (e.g. widespread malignancy).\n* Known monogenic cause of small vessel disease (e.g. CADASIL - Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy)","40 Years",{"count":277,"type":19},"A prospective observational cohort study in patients with cerebral small vessel disease deterring whether changes in systemic inflammation predict brain white matter damage measured using MRI and cognitive decline. This is a study funded by a joint BHF-Dutch Heart Foundation research grant and will be conducted in both Cambridge UK and Nijmegen Netherlands with 100 of the 200 total participants recruited at each site, and data from both sites analysed together.",[442,443,330],"Cerebral Small Vessel Diseases","Inflammation",[445,443,330,446,447,448,449,450],"Cerebral small vessel disease","Cerebrovascular disease","Lacunar stroke","White matter disease","Cognitive impairment","Blood brain barrier","2023-02-17",{"date":453,"type":32},"2023-02-27",{"date":455,"type":32},"2022-08-10",{"date":457,"type":19},"2026-07-31",{"name":38,"class":39},""]