[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Leeds\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,52,87,120,146,170,196,217,241,261,283,313,337,359,381,405,427,452,479],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100053846","the-growing-well-study-100053846",false,"NCT07698158","The Growing Well Study","Growing Well Study: The Role of Portion Size, Plant-based and Commercial Foods on Young Child Growth","GWS","Inclusion Criteria:\n\n* Children aged 6 months-4 years along with their parents or guardians who reside in or near one of the three study locations and planned fieldwork sites: Leeds, Doncaster, or East London. For East London, eligibility includes individuals living in or near Tower Hamlets or an adjacent borough\n* All participants are eligible regardless of background, language, educational ability, or literacy level.\n\nExclusion Criteria:\n\n* Plan to move outside of the study area within the next 12 months\n* Children not living with the consenting parent\u002Fguardian for any part of the week or not living with the consenting parent\u002Fguardian at the time of data collection (e.g. in care, hospital, or living wholly with another family member).\n* Children with significant oral feeding difficulties (e.g. tube-feeding or developmental delays)\n* Children that have been diagnosed with a long-term condition that affects their growth or development (e.g. hormonal or genetic conditions)\n* Children from subgroups where quotas have been filled will be excluded to maintain balanced representation across all study groups (e.g., age 3, non-deprived locations).",true,"ALL","6 Months","4 Years",{"count":22,"type":23},1890,"ESTIMATED","OBSERVATIONAL","What are the study aims? To understand more about eating habits and age-appropriate food\u002Fdrink portion sizes of children aged 6 months-5 years old, and how this affects their growth and dental health.\n\nWhy is this research important? Healthy diets in early years are important for growth and development. However, clear guidance for parents on what and how much children should eat is missing due to lack of up-to-date information.\n\nWhat will the investigators do? Information will be collected at two time points. At baseline, parents\u002Fguardians of children aged 6 months-4 years from Leeds, Doncaster and East London will complete questionnaires about their child's sociodemographic information and food intake. They will be asked to record what their child eats for three separate one-day periods using an online system called 'myfood24'. Parents will also attend one in-person session for measuring their child's length\u002Fheight, weight, and waist circumference.\n\nAt follow-up one year later, parents\u002Fguardians will complete surveys again, with another in-person session to look at growth and assess dental health.\n\nWhat do the investigators expect to achieve and what happens next? They want to understand how growth and dental health are influenced by nutrient intakes, dietary patterns, and portion sizes for key food groups. They will also identify how much of different foods children should be eating, and whether commercial foods and sweet drinks are relevant.\n\nThey will explore which dietary factors can support healthier children; and how low intakes of key foods or vitamins\u002Fminerals in vulnerable groups could be redressed. The study will provide unique information, allowing for development of recommendations for parents and policy-makers on age-appropriate portions, on achieving good nutrition in UK children and within special dietary groups, and on dietary considerations in caring for children's teeth.",[27,28,29,30],"Dietary Behaviors","Child Growth and Development","Dental Health","Dietary Intakes",[32,33,34,35,36,37,38,29],"Early Years","Children","Nutrition","Portion Size","Commercial Foods","Plant-Based Diet","Growth","RECRUITING","2026-07-06",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":43},"2026-01-05",{"date":47,"type":23},"2027-10",{"name":49,"class":50},"University of Leeds","OTHER",6,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100641948","phase-3-personalising-treatment-for-myeloma-patients-based-on-initial-response-to-nhs-treatment-and-their-overall-fitness-level-100641948","NCT07649525","Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level","iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma","iFIT","Eligibility criteria for registration:\n\nInclusion criteria for registration:\n\n1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.\n2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,\n3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,\n4. Aged 18 years or greater,\n5. Able to provide full informed consent, and\n6. Prepared to comply with pregnancy prevention plan.\n\nExclusion criteria for registration:\n\n1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),\n2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,\n3. Previous treatment for myeloma, except as specified in the protocol,\n4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or\n5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.\n\nAdditional eligibility criteria for randomisation into iFIT1\u002FiFIT2\u002FiFIT3 pathways, as follows:\n\nInclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Completed 6 cycles of DRd induction therapy after registering within the iFIT study,\n* Able to provide full informed consent, and\n* Prepared to comply with pregnancy prevention plan.\n\nInclusion criteria specific to randomisation pathways:\n\n* Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),\n* Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),\n* Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),\n* Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),\n* Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),\n* Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),\n* Categorised as FRAIL according to the IMWG frailty index (iFIT2), and\n* Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).\n\nExclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,\n* Received a stem cell transplant,\n* Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and\n* Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.\n\nExclusion criteria specific to randomisation pathways:\n\n* Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),\n* Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and\n* Further exclusion criteria related to safety of interventions (iFIT1).\n\nFull inclusion and exclusion criteria are listed in the protocol.","18 Years",{"count":62,"type":23},1226,"INTERVENTIONAL",[65],"PHASE3","iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.",[68,69],"Multiple Myeloma (MM)","Plasma Cell Leukemia (PCL)",[71,72,73,74,75,76],"Myeloma","Platform adaptive design","Immunotherapy","Frailty","Personalised therapy","Biomarker-driven","NOT_YET_RECRUITING","2026-06-09",{"date":80,"type":43},"2026-06-16",{"date":82,"type":23},"2026-06",{"date":84,"type":23},"2037-05",{"name":49,"class":50},4,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":63,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100624417","non-invasive-vagus-nerve-stimulation-for-chronic-musculoskeletal-pain-100624417","NCT07409363","Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain","A Randomised, Single-blind, Sham-controlled, Crossover Pilot Study Assessing the Effect of Non-invasive Vagus Nerve Stimulation (nVNS) on Autonomic Symptoms and Pain Management in Patients With Chronic Musculoskeletal Pain and Autonomic Dysfunction","RESTORE-MSK","Inclusion Criteria:\n\n1. Individuals diagnosed with musculoskeletal (MSK) conditions and currently experiencing MSK pain lasting for 12 weeks or longer, in line with the ICD-11 criteria for chronic pain.\n2. Identified as having autonomic dysfunction (AD) defined as a score of 17 or more on the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.\n3. Ability to understand and willingness to sign a written informed consent document.\n4. Stated willingness to comply with all study procedures and be available for the duration of the study (approximately 6 weeks).\n5. Ability to read and understand English sufficiently to complete study questionnaires.\n\nExclusion Criteria:\n\n1. Pregnancy (self-reported; safety of nVNS in pregnancy not established).\n2. Advanced heart disease, including: severe heart failure (NYHA Class III-IV), myocardial infarction within the preceding 6 months, or ongoing investigations for cardiac arrhythmias.\n3. Use of an active implantable medical device, including: cardiac pacemaker, implantable cardioverter-defibrillator (ICD), cochlear implant, hearing aid implant, or any other implanted electronic device.\n4. Concurrent use of another electrical stimulation device, including: transcutaneous electrical nerve stimulation (TENS) unit, muscle stimulator, or any other portable electronic stimulation device.\n5. Inability to provide informed consent.",{"count":96,"type":23},12,[98],"NA","Chronic musculoskeletal (MSK) pain affects an estimated 20-33% of the global population and is frequently associated with autonomic nervous system dysfunction, characterised by symptoms such as orthostatic intolerance, palpitations, gastrointestinal dysmotility, and fatigue. Conventional treatments often fail to address this autonomic component, limiting their effectiveness. This pilot study investigates whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction.\n\nRESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening).\n\nThe primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility.\n\nThis pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.",[101,102,103],"Chronic Musculoskeletal Pain","Autonomic Dysfunction","Dysautonomia",[105,106,107,108,109,110],"Vagus Nerve Stimulation","Non-invasive Neuromodulation","Chronic Pain","Autonomic Nervous System","GammaCore","COMPASS-31","2026-05-06",{"date":113,"type":43},"2026-05-11",{"date":115,"type":23},"2026-05-14",{"date":117,"type":23},"2026-07-31",{"name":49,"class":50},1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":18,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":63,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":119},"100611994","tscs-in-children-and-young-people-with-hcp-100611994","NCT07247812","tSCS in Children and Young People With HCP","The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy","Inclusion Criteria\n\n* Age and Gender: Boys and girls aged 12 to 21 years.\n* Diagnosis: Are diagnosed with Hemiplegic Cerebral Palsy (HCP).\n* Hand Function: Are experiencing difficulties with hand functions in daily activities.\n* Medical Stability: Have stable medical conditions without cardiopulmonary disease or seizures.\n* Motor Capability: Are capable of performing simple motor tasks such as reaching, touching, or grasping objects.\n* Availability: Are able to attend two sessions\n* Consent informed: Are able to provide informed consent (or if under 16, will need to have a parent or legal guardian who is willing to provide consent on their behalf).\n* Language: Are able to speak English (and if under 16, their parent or legal guardian must also be able to speak English)\n\nExclusion Criteria\n\n* Other Neurological Conditions: Have neurological diseases other than cerebral palsy.\n* Blood Pressure: Have uncontrolled or high blood pressure.\n* Recent Surgeries: Have recently undergone significant surgeries (neurological, cardiac, respiratory, or metabolic) without sufficient recovery time.\n* Severe Diseases: Have cardiovascular or pulmonary diseases.\n* Medical Complications: Have ongoing medical complications such as unhealed fractures, contractures, or active infections or cancer.\n* Protocol Compliance: Are unable to follow study protocols safely.\n* Epilepsy History: Have a personal or family history of epilepsy.\n* Recent Injections: Have had botulinum toxin injections within the past six months.\n* Implanted Devices: Have implanted devices like pacemakers or baclofen pumps.\n* Exclusion of Participants with Recent Research Involvement: Participants who have taken part in any clinical research study within the last 3 months will be excluded.","12 Years","21 Years",{"count":130,"type":23},18,[98],"This work will examine if a technique called Transcutaneous Spinal cord stimulation (tSCS), when used with concurrent specific arm and hand exercises, helps improve arm and hand movements in CYP with HCP.\n\nDoes Transcutaneous Spinal Cord Stimulation (tSCS), when combined with specific arm and hand exercises, improve upper limb function in children and young people (CYP) with Hemiplegic Cerebral Palsy (HCP)?\n\n-To determine the feasibility and effectiveness of Transcutaneous Spinal Cord Stimulation (tSCS) combined with targeted arm and hand exercises in improving the upper limb function in children and young people with Hemiplegic Cerebral Palsy (HCP).",[134],"Cerebral Palsy Spastic Hemiplegic",[136,137,138,139],"Cerebral palsy","Transcutaneous Spinal Cord Stimulation","Hemiplegic Cerebral Palsy","Upper Extremity Function","2026-04-29",{"date":111,"type":43},{"date":140,"type":43},{"date":144,"type":23},"2026-09-30",{"name":49,"class":50},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":63,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":4},"100630474","ai-assisted-continuous-stratification-in-neurorehabilitation-of-stroke-using-personalized-digital-twins-100630474","NCT07488143","AI-assisted Continuous Stratification in Neurorehabilitation of Stroke Using Personalized Digital Twins","STRATIF-AI","Inclusion Criteria:\n\n* Aged over 18\n* Cognition and physical ability sufficient to use the technology\n* Diagnosis of ischaemic or haemorrhagic stroke, including subarachnoid haemorrhage\n* Admitted within 6 months of stroke to an inpatient rehabilitation site in Leeds Teaching Hospitals NHS Trust\n\nExclusion Criteria:\n\n* Previous or concomitant neurological condition\n* Other major disabling condition prior to stroke\n* Cognition or physical ability impaired to the extent that the user lacks the capacity to consent to participation in the study or to engage with the technology",{"count":154,"type":23},30,[98],"The goal of this clinical trial is to learn if a rehabilitation application on a smartphone, an app, can be used by adults who have had a stroke. The main questions it aims to answer are:\n\nAre people who have had a stroke able to use the app? Is the app useful for people who have had a stroke? Will the app adapt to the needs of the person recovering from a stroke?\n\nResearchers will compare the app to the usual rehabilitation a person receives after a stroke to see if the app can be used as part of a person's rehabilitation.\n\nParticipants will:\n\nUse the app every day for 6 weeks Have an assessment with a rehabilitation research doctor before starting using the app and after completing using the app Keep a diary of the exercises that they do using the app",[158],"Stroke",[160,158,161],"Rehabilitation","Digital twin","2026-03-18",{"date":164,"type":43},"2026-03-23",{"date":166,"type":23},"2026-05-01",{"date":168,"type":23},"2027-05-30",{"name":49,"class":50},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":18,"minAge":178,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":4},"100621224","find-hf-risk-guided-screening-for-heart-failure---pilot-study-100621224","NCT07367841","FIND HF Risk-guided Screening for Heart Failure - Pilot Study","FIND HF: Risk-guided Screening for Heart Failure","FIND HF","Inclusion Criteria:\n\nRegistered with a doctor practice that uses electronic health system to record patient medical notes Age at enrolment greater or equal to 40 Identified as at risk of developing Heart Failure\n\nExclusion Criteria:\n\nRegistered with a doctor practice that is participating in research studies relating to heart failure screening\n\n* Known diagnosis of HF\n* On the palliative care register\n* Unable to give written informed consent for participation in the study\n* Unable to adhere to the study requirements","40 Years",{"count":180,"type":23},475,"The goal of this clinical trial is to learn if the FIND HF algorithm detection rates of heart failure during testing are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk in a population identified as at risk of undiagnosed heart failure. The main questions it aims to answer are:\n\n* Are people who are identified as high risk by the FIND-HF tool more likely to be diagnosed with heart problems during testing than those identified as low risk?\n* Are people identified as high risk by the FIND-HF tool more likely to show signs of heart problems during testing than those identified as low risk?? Researchers will compare patients in the high risk and low risk groups to see if more patients are detected with asymptomatic heart failure in the high risk group compared to the low risk group.\n\nParticipants will attend one visit at a local clinic where they will undergo an NT proBNP blood test which indicates heart failure and an echocardiogram to evaluate the heart's chambers, valves and overall function to help diagnose various heart conditions.",[183],"Heart Failure",[185,186,187,183],"Artificial Intelligence","Data Science","Health Inequalities","2026-01-19",{"date":190,"type":43},"2026-01-26",{"date":192,"type":23},"2026-02",{"date":194,"type":23},"2028-10",{"name":49,"class":50},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":17,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":119},"100616739","the-force-frequency-relationship-in-heart-failure-and-diabetes-mellitus-a-metabolic-aetiology-100616739","NCT07309523","The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?","The Force Frequency Relationship in Heart Failure: an Expression of a Metabolic Problem Driving Adverse Remodelling?","Inclusion Criteria:\n\n* Guideline-compliant, clinical indication for pacemaker implantation\n* Age \\>18 years\n* Ability to provide written informed consent\n* Persons who are legally competent and mentally able to follow the instructions of the study staff\n\nExclusion Criteria:\n\n* Anemia Hb \\\u003C8 mg\u002Fdl\n* Patients with acute infectious diseases (e.g. pneumonia)\n* Patients with heart failure due to sepsis\n* People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress\n* Patients with acute liver or kidney failure\n* Pregnant and breastfeeding women\n* People who are institutionalized on official or court orders\n* People who are dependent or employed by the sponsor or investigator\n* Taking study medication (of an investigational drug) 30 days before the start of the study\n* Known contrast allergy or eGFR \\\u003C20ml\u002Fmin\u002F1.73m2\n* Pregnancy not excluded by bedside pregnancy test in premenopausal women",{"count":204,"type":23},160,"The present investigation is a non-randomised, observational study involving an unselected but highly phenotyped cohort of patients undergoing pacemaker or defibrillator implantation from whom a small sample of fat and muscle will be taken from the operation site, and, in a subgroup, from the thigh muscle. A sample of blood wil also be taken from the vein of the heart, a peripheral vein and the artery at the wrist during the procedure at different heart rates and pacing modes, to describe how heart rate and heart contraction power relate to cardiac and peripheral metabolism.\n\nThe coded blood and tissue samples and anonymised clinical data will be stored in a Human Tissue Authority-approved freezer until analysis.\n\nFollowing the procedure, during routine visits, patients' left ventricular force frequency relationship will be assessed using cardiac ultrasound and a non-invasive cardiac monitor to further phenotype the severity and progression of their heart function over 6 months. For most patients, their involvement will end at that point although they will be monitored through electronic health records on an annual basis from that point forward for up to 5 years after the end of the study (for up to ten years after that point) to gain information on the prognostic value of the metabolic and haemodynamic testing.\n\nThe present investigation will allow the investigators to advance the understanding of heart-muscle crosstalk with the goal of developing targeted interventions that could open new treatment avenues.",[183,207],"Diabetes (DM)",[209],"Force frequency relationship, heart failure, diabetes mellitus, Treppe","2025-12-29",{"date":45,"type":43},{"date":213,"type":43},"2024-09-01",{"date":215,"type":23},"2034-08-30",{"name":49,"class":50},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":63,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100404726","phase-1-a-platform-study-of-novel-agents-in-combination-with-radiotherapy-in-nsclc-100404726","NCT04550104","A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC","A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer","CONCORDE","Core Inclusion Criteria (Radiation Phase)\n\n1. Histologically or cytologically confirmed NSCLC (patients where the local MDT agree the diagnosis is NSCLC after review of the available pathology and imaging at MDT can be enrolled after discussion with the CI).\n2. Not suitable for concurrent chemoradiotherapy\u002Fsurgery due to tumour or patient factors\n3. Stage IIB and III (TNM 8th Edition).\n4. Planned to receive RT at curative intent doses (i.e., 60Gy) as part of treatment plan (either with or without induction chemotherapy).\n5. Patient considered suitable for radical RT by the local lung cancer multidisciplinary team and a clinical oncologist.\n6. If chemotherapy has been given previously, the maximum interval between the last day of chemotherapy and the start of RT \\\u003C10 weeks.\n7. Age ≥18\n8. Life expectancy estimated to be greater than 6 months.\n9. Karnofsky Performance status ≥70.\n10. MRC dyspnoea score \\\u003C3.\n11. Forced expiratory volume in one second (FEV1) ≥35% predicted and diffusing capacity of the lungs for carbon monoxide (DLCO or TLCO) ≥35% predicted.\n12. Patient must be fully informed about the study and have signed the informed consent form.\n13. Patient must be willing and able to comply with the protocol, have mental capacity and (if relevant) use effective contraception throughout treatment and for 4 months for women of childbearing potential, and 6 months for men after treatment completion. Treatment is defined as including the last dose of durvalumab or DDRi in the consolidation phase.\n14. Adequate organ function as defined in master protocol.\n15. Patient has a body weight of \\>30kg.\n\nCore Exclusion Criteria (Radiation Phase)\n\n1. Mixed non-small cell and small cell tumours.\n2. Confirmed progressive disease during induction chemotherapy.\n3. Participation in a study of an investigational agent or using an investigational device within 4 weeks prior to the anticipated start of treatment.\n4. Current or previous malignant disease which may impact on a patient's estimated life expectancy (other than NSCLC).\n5. History of interstitial pneumonitis.\n6. Prior thoracic radiotherapy.\n7. Prior treatment with pneumotoxic drugs, e.g. busulfan, bleomycin, within the past year. If prior therapy in lifetime, then exclude if history of pulmonary toxicities from administration. Patients who have received treatment with nitrosoureas (e.g., carmustine, lomustine) in the year before study entry without experiencing lung toxicity are allowed on study.\n8. Mean resting corrected QT interval (QTcF) \\>470 msec obtained from 3 electrocardiograms.\n9. Received a prior autologous or allogeneic organ or tissue transplantation.\n10. Patients unable to swallow orally administered medications or chronic gastrointestinal (GI) disease likely to interfere with absorption of IMP in the opinion of the treating investigator (e.g. malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease etc.).\n11. Grade 2 or higher peripheral sensory neuropathy.\n12. Known positive test for human immunodeficiency virus, active hepatitis B or C infection.\n13. Positive pregnancy test (at eligibility assessment for women of childbearing potential) or breast-feeding women.\n14. Patients with persistent toxicities (\\>CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.\n15. Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML.\n16. Major surgery within 2 weeks of confirmation of eligibility.\n17. Patients considered a poor medical risk by the investigator due to a serious, uncontrolled medical disorder, non-malignant system disease or active uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled hypertension, uncontrolled atrial fibrillation, active bleeding, recent (within 3 months) myocardial infarction, major seizure, active COVID-19, any psychiatric disorder that prohibits obtaining informed consent.\n18. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\n19. Exclusions as described in the relevant study arm protocol. Patients ineligible for a particular study arm may be considered for entry into an alternative study arm if an appropriate slot is available and they meet all the inclusion and exclusion criteria for that arm. This will need to be discussed with CTRU and the patient will be required to reconsent using the appropriate study arm PIS\u002FICF.\n\nCore Inclusion Criteria (Consolidation Phase)\n\n1. A minimum of 4 and a maximum of 8 weeks\\* have elapsed following completion of RT\n2. Any toxicities from RT have resolved to grade 1. If patient has pneumonitis following RT treatment, this must be asymptomatic (grade 1). If pneumonitis is ≥2 or requiring steroids, then participant is not eligible\n3. Karnofsky Performance status ≥70\n4. The laboratory requirements set out in Table 1 of the master protocol are met\n5. Patient has no known hypersensitivity to the excipients of durvalumab\n6. Patient has body weight of \\>30kg \\*Investigators should ideally aim to start consolidation treatment within 6 weeks, following the receipt of the CT scan results to rule out progression.\n\nCore Exclusion Criteria (Consolidation Phase)\n\n1. Progressive disease during RT or at the end of RT treatment response assessment.\n2. Participant declines treatment in the consolidation phase.\n3. Patients who have received prior anti-PD-1 or anti PD-L1 treatment.\n4. Major surgery within 4 weeks of confirmation of eligibility for consolidation phase.\n5. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.\n6. Patients considered a poor medical risk by the investigator due to a serious, uncontrolled medical disorder, non-malignant system disease, active GI infection or active uncontrolled infection.\n7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease e.g., colitis or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc).",{"count":226,"type":23},200,[228],"PHASE1","CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB\u002FIIIA\u002FIIIB NSCLC, followed by up to 12 months of consolidation durvalumab immunotherapy in selected study arms. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.",[231],"Non Small Cell Lung Cancer","2025-12-18",{"date":234,"type":43},"2025-12-19",{"date":236,"type":43},"2021-03-17",{"date":238,"type":23},"2028-03",{"name":49,"class":50},14,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":119},"100514317","evaluating-treatable-traits-across-the-spectrum-of-chronic-obstructive-airways-disease-100514317","NCT05976919","Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease","Inclusion Criteria:\n\n* Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.\n* Non \u002F ex-smokers (packs recorded as cigarettes per day \u002F years smoked).\n* Male or female aged 18-65 years\n* Ability to provide written informed consent.\n* Full comprehension of spoken and written English language.\n* Cystic Fibrosis patients on triple CFTR modulators (90% cohort)\n* Cystic Fibrosis patients on no CFTR modulators\n* Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.\n\nExclusion Criteria:\n\n* Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.\n* Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.\n* Absolute or relative contraindications to pulmonary function testing .\n* Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).\n* Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.\n* Significant cognitive impairment (i.e., unable to provide written informed consent or safely \u002F successfully perform tests).\n* Currently receiving oxygen therapy.\n* Inability to consent.\n* Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.\n* Lung transplantation\n* Diagnosis of cardiovascular disease.\n* Abnormal blood screening (anaemia, moderate \u002F severe renal failure etc.)","65 Years",{"count":249,"type":23},100,"Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific \"treatable traits\") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.",[252],"Airway Disease","2025-03-25",{"date":255,"type":43},"2025-03-30",{"date":257,"type":43},"2023-10-01",{"date":259,"type":23},"2025-07-31",{"name":49,"class":50},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":18,"minAge":268,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":24,"phases":4,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100370406","clinical-and-immunogenetic-characterization-of-giant-cell-arteritis-gca-and-polymyalgia-rheumatica-pmr-100370406","NCT04102930","Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)","UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)","Inclusion Criteria:\n\n* Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.\n* Have a firm clinical diagnosis of GCA or PMR, or (for patients identified prospectively) GCA or PMR should be more likely than any alternative explanation for the patient's symptoms.\n* Able and willing to give informed consent. Patients will be 50 years of age or over, unless both biopsy-proven and a clinically classical case of GCA.\n\nExclusion Criteria:\n\n• Patient unwilling or unable to give fully informed consent.","50 Years",{"count":270,"type":23},4500,"18 Months","A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. A subset of the retrospective cohort is also enrolled in a post-marketing surveillance registry of patients eligible for, or receiving tocilizumab, to treat their relapsing or refractory GCA.",[274,275],"Giant Cell Arteritis","Polymyalgia Rheumatica",{"date":255,"type":43},{"date":278,"type":43},"2005-06-10",{"date":280,"type":23},"2028-03-31",{"name":49,"class":50},76,{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":17,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":291,"conditions":292,"keywords":296,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":119},"100575571","heart-failure-in-patients-with-diabetes-cells-crosstalk-and-consequences-100575571","NCT06774014","Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences","Inclusion Criteria:\n\n* Age \\>18 years\n* Ability to provide written informed consent\n* Persons who are legally competent and mentally able to follow the instructions of the study staff\n\nExclusion Criteria:\n\n* Anaemia Hb \\\u003C8 mg\u002Fdl\n* Patients with acute infectious diseases (e.g. pneumonia)\n* Patients with heart failure due to sepsis\n* People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress\n* Patients with acute liver or kidney failure or severe COPD (FEV1\\\u003C1.0)\n* Pregnant and breastfeeding women\n* People who are institutionalized on official or court orders\n* People who are dependent or employed by the sponsor or investigator\n* Taking study medication (of an investigational drug) 30 days before the start of the study",{"count":290,"type":23},600,"This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected.\n\nThese data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.",[293,183,294,295],"Diabetes Mellitus Type 2","HFrEF - Heart Failure With Reduced Ejection Fraction","HFpEF - Heart Failure With Preserved Ejection Fraction",[297,298,299,300,301,302,303,304],"Crosstalk","Metabolomics","Proteomics","Fat","Skeletal muscle","Vascular function","Autonomic function","Endothelial function","2025-02-27",{"date":307,"type":43},"2025-02-28",{"date":309,"type":43},"2025-02-26",{"date":311,"type":23},"2030-01-31",{"name":49,"class":50},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":17,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":119},"100574968","impact-of-chronic-cough-on-activities-of-daily-living-and-response-to-acute-high-intensity-exercise-100574968","NCT06766175","Impact of Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise","Inclusion Criteria:\n\n* Age \\>18 years\n* Chronic cough as per European Respiratory Society definition (\\>8 weeks duration)\n* High symptom burden (i.e., cough visual analogue scale \\>40 mm at pre-study screening)\n* Chest radiograph or CT within 3 years of the screening visit with no abnormalities considered to contribute to chronic cough\n\nExclusion Criteria:\n\n* Smokers or individuals who gave up smoking within 12 months\n* Smoking history \\>20 pack-years\n* Long-COVID or post-COVID syndrome (defined as symptoms lasting over 12-weeks in duration)\n* Recent exacerbation of cough within 4 weeks of inclusion\n* Respiratory tract infection within 4 weeks of inclusion\n* Currently taking any of the following medications:\n\n  * ACE inhibitors and within 3 months of inclusion\n  * Antitussives (opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, or over the-counter medications) within 2 weeks of inclusion\n  * Medical treatments for gastro-oesophageal reflux disease (GORD), eosinophilic bronchitis or other cough related conditions, initiated or changed (i.e., not in a stable regimen) for 4 weeks prior to inclusion\n* Medical history of asthma or exercise-induced bronchoconstriction (EIB), COPD, or chronic bronchitis in the judgement of the investigator\n* Medical conditions\u002Fhistory or other circumstances which, in the judgement of the investigators, could increase the risk of adverse events or bias the study results",{"count":320,"type":23},129,"Chronic cough is a common and debilitating condition that affects up to 10% of the global population. The health impact of chronic cough is multifaceted and manifests both physical and psychological symptoms including syncope, chest pain, lethargy, depression and anxiety. It is now also recognised that chronic cough often leads to social isolation and may impact an individual's ability or confidence to undertake routine daily tasks \u002F lead an active lifestyle.\n\nThe primary aim of this study is therefore to characterise the impact of unexplained chronic cough on the ability to undertake daily activities - i.e., determine whether individuals with chronic cough exhibit impaired levels of physical activity during usual daily living when compared with healthy age, gender and BMI matched controls. A secondary aim is to assess the short-term impact of high-intensity exercise on cough (i.e., determine whether an acute bout of exercise alters cough frequency and\u002For severity).",[323],"Chronic Cough (CC)",[325,326,327,328],"Cough","Physical activity","Exercise","Physiology","2025-01-03",{"date":331,"type":43},"2025-01-09",{"date":333,"type":43},"2024-12-01",{"date":335,"type":23},"2026-12",{"name":49,"class":50},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":63,"phases":345,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":119},"100534559","phase-2-digoxin-and-senolysis-in-heart-failure-and-diabetes-mellitus-100534559","NCT06240403","Digoxin and Senolysis in Heart Failure and Diabetes Mellitus","Digoxin: a New Senolytic to Repair Dysfunctional Adipose Tissue in Patients With Heart Failure and Type II Diabetes Mellitus","Inclusion Criteria:\n\n* Aged ≥18yrs,\n* HFrEF (LVEF\\\u003C40%)\n* T2DM (taking anti-diabetic medication, fasting plasma glucose ≥7.0 mmol\u002FL and\u002For a serum HbA1c \\>48mmol\u002FL\n* On optimal medical therapy,\n* Able\u002Fprepared to give informed written consent.\n\nExclusion Criteria:\n\n* Significant cognitive impairment,\n* Important co-morbidity limiting ability to comply with study procedures,\n* Hyperkalemia (\\>5.5mmol\u002FL)\n* eGFR\\\u003C30ml\u002Fmin\u002F1.73m2\n* Current\u002Fprevious (\\\u003C6m) participation in other studies.",{"count":249,"type":23},[346],"PHASE2","In pilot studies the investigators have shown that subcutaneous adipose tissue (SAT) from patients with reduced ejection fraction heart failure (HFrEF) and type 2 diabetes mellitus (T2DM) is dysfunctional. Endothelial cells from the adipose tissue from these patients are senescent and have deleterious effects on healthy human subcutaneous adipocytes, including increasing expression of IL-6 (gene and protein) and reducing glucose uptake. Digoxin, a well-established treatment for HFrEF, selectively clears these senescent endothelial cells and prevents adipocyte dysfunction. This study will examine the effect of digoxin on adipose tissue on the burden of senescent cells.",[349,350],"Heart Failure, Systolic","Diabetes Mellitus, Type 2","2024-12-04",{"date":353,"type":43},"2024-12-06",{"date":355,"type":23},"2025-09-01",{"date":357,"type":23},"2029-08-28",{"name":49,"class":50},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":63,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":119},"100377935","phase-2-optimising-pacing-for-contractility-2-100377935","NCT04201015","Optimising Pacing for Contractility 2","Mechanisms, Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life","OPT-cont 2","Inclusion Criteria:\n\n* Clinical, echocardiographic and neurohormonal evidence of heart failure\n* Cardiac pacemaker,\n* Able to perform a peak exercise test,\n* Willing and able to give informed consent.\n\nExclusion Criteria:\n\n* Angina pectoris symptoms limiting exercise tolerance,\n* Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,\n* Calcium channel blockers (CCBs).",{"count":368,"type":23},400,[346,65],"The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be.\n\n450 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.",[349,372],"Pacemaker","2024-09-24",{"date":375,"type":43},"2024-09-26",{"date":377,"type":43},"2020-06-01",{"date":379,"type":23},"2025-03-31",{"name":49,"class":50},{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":63,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":119},"100550726","prospect-prior-2-chemo-prior-dental-intervention-before-chemo-to-reduce-chemotherapy-complications-100550726","NCT06450821","PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications","PROSpECT-PRIOR-2-CHEMO: A Feasibility RCT of Novel Dental Intervention PRIOR[Proactive Intensive Oral Review & Treatment] in Patients Scheduled for Chemotherapy for Myeloma-ASCT & Hematological Cancers to Mitigate Chemotherapy Complications","Inclusion Criteria (mod-high\u002Frisk trial participants):\n\n* Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:\n\n  * Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.\n  * Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT\n* Moderate \u002F High Oral Health Risk Assessment - any one of the following:\n\n  * Clinical evidence of caries (2+ teeth)\n  * Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness\n  * BPE code 3-4 in any remaining sextant\n  * BPE code 1-2 with \\>30% BOP\n* The patient is fully informed, has received PIS (patient information sheet) and considered during a 'cooling-off' period, is competent to consent, and is able to comply with minimum attendance requirements\n\nExclusion Criteria:\n\n* Have a history of head and neck radiotherapy\n* Have been treated with Denusomab, Bevacizumab, Sunitinib or Aflibercept within 9 months of the MDT date.\n* Insufficient teeth \\[defined as \\\u003C2\\]\n* Are incapable of providing informed written consent\n* Are unable to comply with minimum attendance requirements",{"count":389,"type":23},60,[98],"The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.",[393,394,71,395,396],"Oncology","Periodontitis","Oral Mucositis","Febrile Neutropenia","2024-06-04",{"date":399,"type":43},"2024-06-10",{"date":401,"type":23},"2024-07",{"date":403,"type":23},"2026-10",{"name":49,"class":50},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":413,"minAge":60,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":63,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":426,"locationsCount":4},"100486486","prostate-reirradiation-toxicity-outcomes-feasibility-study-100486486","NCT05614700","Prostate Reirradiation Toxicity Outcomes Feasibility Study","Reirradiation Options for Previously Irradiated Prostate Cancer (RO-PIP): Feasibility Randomised Clinical Trial Investigating Toxicity Outcomes Following Reirradiation With Ultra-hypofractionated External Beam Radiotherapy vs. High Dose Rate Brachytherapy","RO-PIP","Inclusion Criteria:\n\n* Male individuals aged over 18 years\n* Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)\n* No metastatic disease\n* Able and willing to provide an informed consent to participate\n* World Health Organisation (WHO) performance status 0-2\n* Reasonable urinary function (IPSS \\\u003C 20 and Qmax \\> 10 ml\u002Fsecond on flow tests)\n* Greater than 10 year life expectancy\n\nExclusion Criteria:\n\n* Patients who are unfit for a general anaesthetic due to other comorbidities\n* Clinical or radiological evidence of metastatic prostate disease\n* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent\n* Contraindication or intolerance of magnetic resonance scanning\n* Prior prostatectomy\n* History of inflammatory bowel disease.","MALE",{"count":389,"type":23},[98],"The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.",[418,419],"Prostate Cancer","Radiotherapy Side Effect","2022-11-14",{"date":422,"type":43},"2022-11-15",{"date":422,"type":23},{"date":425,"type":23},"2026-11-15",{"name":49,"class":50},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":63,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":119},"100317723","vitamin-d-treating-chronic-heart-failure-the-effect-of-vitamin-d-supplementation-in-patients-with-heart-failure-100317723","NCT03416361","VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)","VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation on Hospitalisation and Mortality in Patients With Heart Failure): Multicentre, Phase III, Randomised Placebo-controlled Trial","VINDICATE2","Inclusion Criteria:\n\n* LVSD (LVEF \\\u003C50%);\n* stable medical and device therapy for \\>3mths;\n* 25\\[OH\\]vitamin D3 \\\u003C50nmol\u002FL\n* At least one of: recent (\\\u003C1 year) hospitalisation for HF, high dose loop diuretic requirement (\\>80mg daily furosemide equiv), diabetes mellitus, ischaemic aetiology\n\nExclusion Criteria:\n\n* Unwilling\u002Funable to sign consent,\n* Severe cognitive impairment,\n* Severe COPD,\n* Anaemia,\n* Other life-threatening co-morbidity (in the opinion of the local co-investigator),\n* Known and active sarcoidosis or tuberculosis",{"count":436,"type":23},1253,[98],"VINDICATE 2 will be a randomised, placebo-controlled, parallel group, double-blind study of vitamin D versus placebo in otherwise optimally-managed patients with CHF due to LVSD and vitamin D deficiency (\\\u003C50nmol\u002FL). The intervention will be a daily dose of 4000IU (100µg) per day or matching placebo for a minimum of 2 years and a maximum of 4 years.",[440],"Chronic Heart Failure",[442,443],"Left ventricular dysfunction","Vitamin D","2022-10-31",{"date":446,"type":43},"2022-11-02",{"date":448,"type":23},"2023-12-01",{"date":450,"type":23},"2027-03-01",{"name":49,"class":50},{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"100340735","prognostic-imaging-biomarkers-for-diabetic-kidney-disease-100340735","NCT03716401","Prognostic Imaging Biomarkers for Diabetic Kidney Disease","iBEAt","Inclusion Criteria:\n\n* Diagnosis Diabetes Type 2;\n* eGFR \\>= 30 ml\u002Fmin\u002F1.73m2;\n* Able to provide informed consent;\n* Age between 18 years and 80 years;\n* Unchanged antidiabetic and antihypertensive medication for the past 3 months (not including dose changes).\n\nExclusion Criteria:\n\n* Transplantation (except corneal);\n* On permanent dialysis;\n* Significant comorbidities with life expectancy of \\\u003C 1 year;\n* Use of investigational drug within 1 month prior to screening;\n* Known clinical history of urinary obstruction on renal US: either post-voiding residue over 100 ml, or pyelectasis;\n* Known clinical history of aortic endoprosthesis at the renal level;\n* Current pregnancy;\n* History of Hepatitis B or Hepatitis C +;\n* Use of antiretroviral medication;\n* Known current or clinical history of renal or urinary tract malignancy;\n* Concurrent other renal disease (suspected or proven);\n* Cirrhotic liver disease, or non-cirrhotic chronic liver disease where ALT \\>2 x upper limit of normal;\n* Current metastatic malignancy;\n* Current malignancy with expected survival \\\u003C study follow up period (4 years);\n* Melanomatous skin cancer \\\u003C 5 years ago (fully resected melanoma \\>5 years ago, i.e. surgical cure, can be recruited);\n* Any other significant disease or disorder which, in the opinion of the investigators, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study;\n* Cochlear Implant;\n* Aneurysm Clips;\n* Neurological stimulator;\n* Implanted cardiac devices (ICD, PPM, loop recorders, or any others);\n* Metal heart valve;\n* History of metal foreign bodies in orbits;\n* Other implanted metal device which prevents MR imaging;\n* Known allergy to Gadolinium contrast;\n* Claustrophobia;\n* Weight exceeding 250 kg;\n* \\[Bari arm\\] Absolute contraindications to percutaneous renal biopsy;\n* \\[Bari arm\\] Bleeding diathesis;\n* \\[Bari arm\\] Severe uncontrolled hypertension;\n* \\[Bari arm\\] End stage renal disease with small hyperechoic kidneys;","80 Years",{"count":461,"type":23},500,"Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment.\n\nOne promising approach for identifying patients that are at risk is the use of imaging measurements (called \"biomarkers\") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available.\n\nThe investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine.\n\nThe investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.",[464],"Diabetic Kidney Disease",[466,467,468,469],"Magnetic Resonance Imaging","Ultrasound Imaging","Biomarkers","Prognosis","2021-01-08",{"date":472,"type":43},"2021-01-11",{"date":474,"type":43},"2018-09-01",{"date":476,"type":23},"2038-09-01",{"name":49,"class":50},7,{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":63,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":500},"100328897","phase-3-the-role-of-ixazomib-in-autologous-stem-cell-transplant-in-relapsed-myeloma---myeloma-xii-accord-100328897","NCT03562169","The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)","A Phase III Study to Determine the Role of Ixazomib as an Augmented Conditioning Therapy in Salvage Autologous Stem Cell Transplant (ASCT) and as a Post-ASCT Consolidation and Maintenance Strategy in Patients With Relapsed Multiple Myeloma","Inclusion Criteria:\n\n1. Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT).\n2. First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3).\n4. Aged at least 18 years.\n5. Participants must have the following blood results within 14 days before registration:\n\n   1. Absolute neutrophil count (ANC) ≥1x109\u002FL\n   2. Platelet count ≥75x109\u002FL. If the participant has ≥50% bone marrow infiltration a platelet count of ≥50x109\u002FL is allowed.\n\n   Platelet transfusions are not allowed within 3 days before registration in order to meet these values.\n6. Adequate renal function within 14 days before registration:\n\n   a. Creatinine clearance ≥30ml\u002Fmin (calculated according to the Cockcroft-Gault equation or other locally approved formula)\n7. Adequate hepatobiliary function within 14 days before registration:\n\n   1. Total bilirubin \\\u003C2 x upper limit of normal (ULN)\n   2. ALT \\\u003C2 x ULN\n8. Adequate pulmonary function within 14 days before registration:\n\n   a. Adequate respiratory functional reserve (delineated by KCO\u002FDLCO (carbon monoxide diffusion in the lung) of ≥50%). No evidence of a history of pulmonary disease. If a significant history, then a review by a respiratory medicine physician is required.\n9. Adequate cardiac function within 12 weeks before registration\n\n   a. Left ventricular ejection fraction (LVEF) ≥40%. Note: repeat confirmation of cardiac function is needed if treatment is given between this assessment and registration.\n10. Female participants who:\n\n    1. Are not of childbearing potential (Appendix 8), OR\n    2. If they are of childbearing potential (Appendix 8), agree to practice 2 effective methods of contraception (Appendix 8), at the same time, from the time of signing the informed consent form until 90 days after the last dose of study drug, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g. calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n\n    Male participants, even if surgically sterilised (i.e. status post-vasectomy), must agree to one of the following:\n    1. Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\n    2. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.) Contraception for female and male participants must be in accordance with (and consent to) the Celgene-approved Thalidomide Pregnancy Prevention Programme.\n11. If female and of childbearing potential (see Appendix 8), must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene Thalidomide Pregnancy Prevention Programme.\n12. Patients agree not to receive other clinical trials treatment, including investigational medicinal products (IMPs) not included in this trial, within 30 days of trial registration and throughout the duration of the trial, until disease progression.\n13. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Received prior second line therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone (up to a maximum of 200mg is allowed but not within 30 days prior to registration). Radiotherapy sufficient to alleviate or control pain of local invasion is permitted, but must not be within 14 days before registration. Patients who have received hemi-body radiation or similar since relapse will not be eligible.\n2. ≥Grade 2 peripheral neuropathy within 14 days before registration.\n3. Known HIV seropositivity.\n4. Known resistance, intolerance or sensitivity to any component of the planned therapies.\n5. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.\n6. Previous or concurrent malignancies at other sites (excluding completely resected non-melanoma skin cancer or carcinoma in situ of any type, such as cervical cancer).\n7. Pregnant, lactating or breast feeding female participants.\n8. Failure to have fully recovered (i.e.Grade 1 or less toxicity) from the reversible effects of prior chemotherapy.\n9. Major surgery within 14 days before registration.\n10. Central nervous system involvement with myeloma.\n11. Ongoing or active infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration.\n12. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n13. Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.\n14. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing.\n15. Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.\n16. Participant has current or prior hepatitis B or C infection.",{"count":487,"type":23},406,[65],"Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase).\n\nPrimary Objectives\n\nThe primary objectives of this study are to determine:\n\n* The impact on Depth of Response (DoR: less than VGPR versus VGPR or better) when salvage ASCT conditioning is augmented by the addition of a proteasome inhibitor\n* The influence of a consolidation and maintenance strategy on the Durability of Response (DuR:PFS)\n\nSecondary objectives\n\nThe secondary objectives of this study are to determine:\n\n* Overall survival\n* Time to disease progression\n* The overall response rate following ixazomib, thalidomide and dexamethasone (ITD) re-induction\n* Time to next treatment\n* Progression-free survival 2 (PFS2)\n* Duration of response\n* Minimal Residual Disease (MRD) negative rate post re-induction, post-ASCT and conversion after ITD consolidation\n* Engraftment kinetics\n* Toxicity and safety\n* Quality of life (QoL)\n\nParticipant population (refer to protocol section 9 for a full list of eligibility criteria).\n\n* Relapsed MM (with measurable disease by IMWG criteria) previously treated with ASCT\n* First progressive disease (PD) at least 12 months since first ASCT, requiring therapy.\n* ECOG Performance Status 0-2\n* Aged at least 18 years\n* Adequate full blood count and renal, hepatobiliary, pulmonary and cardiac function\n* Written informed consent\n\nInterventions: All participants will be registered at trial entry and will receive re-induction therapy with 4-6, 28-day cycles of ixazomib, thalidomide and dexamethasone (ITD), in order to reach maximum response. Participants who achieve at least stable disease (SD) will be randomised on a 1:1 basis to receive either conventional ASCT (ASCTCon), using melphalan, or augmented ASCT (ASCTAug), using melphalan with ixazomib. All participants achieving or maintaining a minimal response (MR) or better following trial ASCT will undergo a second randomisation to consolidation and maintenance or no further treatment. Participants randomised to consolidation and maintenance will receive treatment as follows: consolidation with 2 cycles of ITD and maintenance with ixazomib until disease progression.\n\nNumber of participants: 406 participants will be registered into the trial to allow 284 participants to be randomised at the first randomisation (R1) and 248 participants to be randomised at the second randomisation (R2).",[491],"Multiple Myeloma","2018-06-07",{"date":494,"type":43},"2018-06-19",{"date":496,"type":43},"2017-03-20",{"date":498,"type":23},"2027-03",{"name":49,"class":50},91,""]