[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guy's and St Thomas' NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,45,82,114,143,165,190,212,235,259,279,295,322,348,390,412,433,461,485,521,547,583,605,632,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100644627","metagenomic-analysis-of-the-pharynx-in-high-risk-partners-100644627",false,"NCT07671014","Metagenomic Analysis of the Pharynx in High Risk Partners","A Preliminary Investigation to Determine the Utility of Using Metagenomic Analysis of Pharyngeal Samples Taken From Partners of Patients Diagnosed With Gonorrhoea to Identify Organisms, Antibiotics Resistance and Virulence Factors of Neisseria Species and the Impact of STI Prevention Strategies (4CMenB Vaccination and DoxyPEP)","Inclusion Criteria:\n\n* Partner alerted of their risk about being a partner of someone diagnosed with Neisseria Gonorrhea using the digital partner notification software SXT and then booking an appointment for standard of care testing.\n\nExclusion Criteria:\n\n* Under 18 years, unable to speak English","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The Neisseria gonorrhoea (NG) epidemic in England is at the highest level in one hundred years of public health records. The World Health Organisation has listed NG as one of the top five bacterial infections globally because of the ability of the bacteria to develop resistance to antibiotics. Neisseria meningitidis (NM) is a common pharyngeal commensal and it has been shown to be in one in five men who have sex with men (MSM) in London.\n\nIn the last year sexual health clinics have had a growing number of MSM presenting with urethritis \u002F proctitis that were treated for NG on the day only to be found later to have been infected with NM from the culture. It appear that virulence factors have been passed from NG to NM enabling these bacteria to infect the urogenital and anal mucosa; consequently, NM in some cases is a new Sexually Transmitted Infection (STI). In 2025, two STI prevention interventions were rolled out in an attempt to address the gonorrhoea \\& syphilis epidemics and these were the 4CMenB vaccine and doxycycline post exposure prophylaxis (DoxyPEP).\n\nThis study will recruit sexual partners of patients who have been diagnosed with NG and the investigators will ask the participant for one additional pharyngeal sample for research that will not impact on their standard of care. The additional sample will be tested using metagenomics, that is where all non-human DNA is analysed, and the initial focus will be on NG or NM infection, co-infection, genes for virulence and antibiotic resistance from whole genome sequencing.\n\nThe metagenomic analysis is being undertaken for research purpose only; however, secondary outcomes will look for other STIs in the pharyngeal sample and sample turn around time to inform the management of patients. Any additional STI identified will have validated testing to confirm diagnosis.",[25,26,27,28],"Gonorrhea","Neisseria Gonorrhea","Neisseria Meningitidis","Metagenomic Next Generation Sequencing",[25,30,31,32],"Metagenomic testing","Neisseria Gonorrhoea","Neisseria Meningitis","NOT_YET_RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":21},"2026-07-14",{"date":41,"type":21},"2027-02-28",{"name":43,"class":44},"Guy's and St Thomas' NHS Foundation Trust","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":71,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100644320","research-patients-and-clinical-research-nurses-exploring-their-experiences-of-taking-part-in-clinical-research-in-the-nhs-100644320","NCT07663058","Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS","SHARE","Inclusion Criteria:\n\nINCLUSION CRITERIA FOR RESEARCH-PATIENTS\n\n* Research-patients aged above 18 years old.\n* Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT.\n* Research-patients who are willing and able to provide informed consent.\n\nINCLUSION CRITERIA FOR CRNS Clinical research nurses (CRNs) currently working in adult clinical research at Guys and St Thomas' NHS Foundation Trust.\n\n• CRN willing and able to give consent.\n\nExclusion Criteria:\n\nEXCLUSION CRITERIA FOR RESEARCH-PATIENTS\n\n* Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility.\n* Research-patients recruited to research via proxy consent, e.g., next of kin.\n* Patients unable to provide informed consent, e.g., lacking mental capacity.\n* Research-patients considered vulnerable or at risk of harm, by the research team\n* Research-patients taking part in mental health or maternity trials or studies\n* Research-patients not fluent in English or not able to converse well in English\n\nEXCLUSION CRITERIA FOR CRNS\n\n* Clinical research midwives and clinical research nurses working in mental health, maternity, and paediatric research are excluded from this study.\n* CRNs not willing or unable to give consent.",true,{"count":54,"type":21},30,"This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research\u002Ftrial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining\u002Ffacilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS\u002FESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.",[57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Experiences","Lived Experiences","Research Participation","Research Subjects","Nurse's Role","Research Ethics","Therapeutic Misconception","Clinical Research Nurses","Research Nurses","Moral Distress","Ethical Dilemma","Research-Patients","Research Nurse and Research-Patient Interactions","Research Experience",[64,68,70,63,72,73],"Ethical Challenges","CRN Dual Role","2026-06-23",{"date":34,"type":37},{"date":77,"type":21},"2026-08-30",{"date":79,"type":21},"2028-12-30",{"name":43,"class":44},1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":17,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":113,"locationsCount":81},"100572331","assessing-the-efficacy-of-photodynamic-therapy-for-preventing-surgical-site-infections-100572331","NCT06731881","Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections","Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study","LIGHT","Inclusion Criteria:\n\n* Patients ≥ 16 years\n* Patients scheduled to undergo elective:\n\n  * Endoscopic Sinus Surgery (ESS) with or without adjunctive Septoplasty and\u002For Turbinoplasty\n  * Septoplasty with or without adjunctive Turbinoplasty\n  * Closed Septoplasty with or without adjunctive Turbinoplasty\n* Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination\n* Willing and able to provide written informed consent prior to participation in the clinical investigation\n* Willing and able to comply with all study related procedures\n\nExclusion Criteria:\n\n-• Patients undergoing open septorhinoplasty, anterior or septal biopsies, or post cautery\n\n* Congenital or acquired immunodeficiency, bone marrow disease, diabetes, autoimmune conditions requiring immunosuppressive treatment, any immunosuppressive medication at the time of consent or within the last 4 weeks before randomisation\n* Primary or secondary ciliary dyskinesia, cystic fibrosis\n* Patients who have received antibiotics within a week before randomisation\n* Patients who receive prophylactic antibiotics or antibiotics prior to discharge\n* Systemic steroid treatment less than 4 weeks before randomisation\n* History of frequent nose bleeds, or a condition that increases the risk of excessive bleeding\n* Undergoing active cancer treatment at time of consent\u002F or planning to start cancer treatment within trial period or completed cancer treatment within the last 4 weeks\n* Any disease, condition (medical or surgical), or drug or alcohol abuse, which, in the opinion of the investigator, might compromise the study results, or would place the patient at increased risk of infection\n* Previously treated with radiation on the face, head, or neck regions\n* Female patients who are pregnant or breastfeeding at the time of consent\n* Received a study drug in a clinical trial for an investigational drug within the previous 30 days from consent, or 5 half-lives, whichever is longer\n* Used antimicrobial wash or wipes within 7 days of randomisation or during the study period\n* Patients with allergies \u002F hypersensitivity to methylene blue, polymethyl methacrylate (PMMA), or to chlorhexidine gluconate (CHG)","16 Years",{"count":92,"type":21},80,"INTERVENTIONAL",[95],"NA","This is a randomised, unblinded interventional device proof of concept pilot trial in which patients undergoing nasal surgery will be selected for either photodisinfection therapy (PDT) with the Steriwave™ ND System, or control with nares swabbed with 'photosensitizer formulation' preoperatively.\n\nThis trial will primarily assess the safety and efficacy of nasal photodisinfection treatment in decreasing post-operative events in patients undergoing nasal surgery. After signing informed consent, and before surgery, participants will receive a baseline culture of the anterior nares to determine nasal bacterial colonization and will have a flexible nasendoscopy to determine their Lund-Kennedy (LK) endoscopic score. Subjects will then be randomised to nasal PDT (which includes two applications of 'photosensitizer formulation' \\[0.01% methylene blue with 0.25% chlorhexidine solution\\], two minutes apart), along with light therapy, or control with nares swabbed twice with 'photosensitizer formulation' with two minutes in between (no light therapy). Following treatment, participants will be re-cultured (2 weeks after the surgery ± 7 days) and reviewed for antibiotic use and surgical site infection (SSI) using LK endoscopic scoring. At 30 days, all participants will be followed up by telephone to review if they received antibiotics for presumed postoperative infection. Standard post-operative care will be provided according to the type of surgery performed. Any required interventions post-operatively will be documented.",[98,99,100],"Surgery","Nasal Disease","Light; Therapy, Complications",[102,103,104,105],"nasal surgery","nasal photodisinfection","decolonisation","surgical site infection","RECRUITING","2026-06-10",{"date":109,"type":37},"2026-06-11",{"date":111,"type":37},"2025-06-04",{"date":36,"type":21},{"name":43,"class":44},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100634071","comparing-the-effects-of-newer-pacemakers-and-their-effects-on-the-heart-and-valve-function-in-the-short-term-100634071","NCT07534917","Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.","Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function","LvL-PACE","Inclusion Criteria:\n\n* All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.\n\nExclusion Criteria:\n\n* LVEF \\\u003C50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy \\\u003C1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.",{"count":123,"type":21},20,"Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.\n\nNewer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.\n\nThe investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.",[126,127,128],"Pacemaker-Induced Cardiomyopathy","Tricuspid Regurgitation","Right Ventricular Dysfunction",[130,131,132,133,134],"leadless pacemaker","left bundle branch area pacing","pacemaker-induced cardiomyopathy","tricuspid regurgitation","right ventricular dysfunction","2026-06-04",{"date":137,"type":37},"2026-06-08",{"date":139,"type":21},"2026-07-01",{"date":141,"type":21},"2029-06-01",{"name":43,"class":44},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":93,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100542185","phase-2-assessment-of-volume-targeted-ventilation-in-patients-with-neuromuscular-disease-100542185","NCT06339580","Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease","A Proof-on-concept Study to Investigate the Potential Use of Volume-targeted Ventilation in Patients With Slowly Progressive Neuromuscular Disease","VT-NMD","Inclusion Criteria:\n\n* Slowly progressive neuromuscular disease\n* Established on fixed bi-level ventilation\n* Documented clinical respiratory stability by supervising clinician (no hospitalizations, respiratory infections or change to ventilator settings in preceding 6 weeks)\n\nExclusion Criteria:\n\n* Rapidly progressive neuromuscular disease\n* Decompensated respiratory failure (pH \\\u003C 7.35)\n* Pregnancy\n* Aged \\\u003C18, \\>80\n* Poor adherence to NIV (\\\u003C4hrs per night)\n* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol","80 Years",{"count":54,"type":21},[154],"PHASE2","Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.",[157],"Neuromuscular Diseases",{"date":137,"type":37},{"date":160,"type":37},"2024-04-09",{"date":162,"type":21},"2026-09-30",{"name":43,"class":44},2,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":52,"sex":17,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":189,"locationsCount":81},"100536858","the-cosp-rbd-study-concussions-and-contact-sports-in-rbd-vs-controls-100536858","NCT06270290","The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls","Observational Cross-sectional Study Investigating the History of Concussion and Exposure to Contact Sports in Patients With REM Sleep Behaviour Disorder (RBD) Versus Controls (Without a Diagnosis of RBD)","COSP-RBD","Inclusion criteria group with RBD:\n\n* Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust).\n* 50 years of age or above (patients below this age would not be expected to have a RBD related to a synucleinopathy and other causes of RBD would need to be considered instead - e.g. narcolepsy, post-traumatic stress disorder).\n\nInclusion criteria control group:\n\n* Patients who have undergone a v-PSG at the SDC (Guy's and St Thomas' NHS Foundation Trust) and who do not have history of suspected RBD or RBD confirmed by v-PSG.\n* 50 years of age or above This group will be age- and sex-matched to the RBD group.\n\nExclusion criteria group with RBD:\n\n* Age \\\u003C 50 years of age.\n* Diagnoses of narcolepsy or post-traumatic stress disorder.\n* Subjects lacking capacity or literacy.\n* Non-English speakers.\n\nExclusion criteria control group:\n\n* Age \\\u003C 50 years of age (in order to match RBD group).\n* REM sleep without atonia or confirmed RBD on v-PSG.\n* Diagnosis of neurological diseases, cognitive complaints or motor complaints.\n* Clinical history suggestive of parasomnia that may be included in the differential of RBD.\n* Subjects lacking capacity or literacy.\n* Non-English speakers.","50 Years",{"count":175,"type":21},140,"The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).\n\nThe main questions it aims to answer are:\n\n* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?\n* Is this proportion higher to that in control patients without a diagnosis of RBD?\n\nParticipants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.\n\nResearchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.",[178,179],"REM Sleep Behavior Disorder","Concussion, Brain",[181,182,183],"REM sleep behaviour disorder","concussion","contact sports","2026-06-03",{"date":135,"type":37},{"date":187,"type":37},"2024-04-23",{"date":162,"type":21},{"name":43,"class":44},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":81},"100527185","study-of-inflammatory-and-physiological-profiles-of-healthy-and-diseased-lung-100527185","NCT06144476","Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung","RETAIN","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Aged 18 years or above\n* Patient: known or suspected airway disease\n* Healthy volunteer: considered to be in good health with no significant comorbidity (immune disorder, cancer etc.)\n\nExclusion Criteria:\n\n* Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.\n* Surgery within the preceding 6 weeks\n* Participants who are pregnant\n* History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may interfere with sample collection, undergo a bronchoscopy, or may compromise study completion or data collection\n* Alcohol or recreational drug abuse\n* Diagnosis of immunodeficiency requiring treatment\n* Unable to provide written informed consent\n* Unable to read or write English\n* Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study",{"count":198,"type":21},230,"There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.",[201,202,203],"COPD","Asthma","Airway Disease",[203,205],"Pulmonary Disease",{"date":135,"type":37},{"date":208,"type":37},"2024-02-08",{"date":210,"type":21},"2029-08-31",{"name":43,"class":44},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":220,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":93,"phases":222,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":81},"100517176","phase-2-volatile-sedation-for-patients-with-the-acute-respiratory-distress-syndrome-100517176","NCT06014138","Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome","Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome","ISO-DRIVE","Inclusion Criteria:\n\n* Adult patients admitted to the Intensive Care Unit (ICU)\n* ARDS\n* Invasive mechanical ventilation (IMV)\n* Spontaneous breathing in pressures support mode (PSV) for less than or equal to 48 hours\n* Sedated with intravenous sedation (ie. propofol and \u002F or midazolam and fentanyl or alternate short acting opioid)\n* Anticipated to remain on IMV and PSV and with a stable sedation score for a further 24 hours without planned sedation interruption \u002F spontaneous breathing trial or other significant change in the level of ventilator support\n* Not receiving \u002F anticipated to receive paralysis\n* In supine position\n\nExclusion Criteria:\n\n* Personal or family history of malignant hyperpyrexia\n* Known or suspected elevated intracranial pressure\n* High dose vasopressors (ie. Noradrenaline \\> 0.3mcg\u002Fkg\u002Fmin or equivalent)\n* Contra-indication to oesophageal balloon (i.e. oesophageal \u002F upper gastro-intestinal pathology)\n* Pregnancy\n* High dose oral sedatives (e.g. benzodiazepines) or opioids (e.g. oxycodone \u002F oral morphine) which may affect respiratory drive","17 Years",{"count":123,"type":21},[154,223],"PHASE3","This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.",[226,227,228],"Acute Respiratory Distress Syndrome","Mechanical Ventilation Complication","Sedation Complication",{"date":135,"type":37},{"date":231,"type":37},"2023-11-01",{"date":233,"type":21},"2027-07-31",{"name":43,"class":44},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":81},"100511868","continuation-of-a-study-to-investigate-the-effect-of-thoracocentesis-on-neural-respiratory-drive-in-pleural-effusion-100511868","NCT05945043","Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion","Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)","COSINE","Inclusion Criteria:\n\n* Age 18 years or above\n* Has a unilateral pleural effusion AND\n\n  1. require thoracocentesis OR\n  2. chest drain insertion (main study only) OR\n  3. has an IPC in situ (main study only)\n\nExclusion Criteria:\n\n* Inability to consent\n* Any contraindications to the proposed pleural procedure\n* Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements\n* Inability to identify surface landmarks for surface EMG electrode placement\n* Past medical history of diaphragmatic paralysis (diaphragm sub study only)",{"count":244,"type":21},124,"The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.",[247],"Pleural Effusion",[249,250,251,252],"Pleural effusion","Breathlessness","Neural respiratory drive","Neurophysiology",{"date":135,"type":37},{"date":255,"type":37},"2023-11-15",{"date":257,"type":21},"2027-06-30",{"name":43,"class":44},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":81},"100380679","investigating-health-related-quality-of-life-in-patients-with-chronic-respiratory-failure-100380679","NCT04236726","Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure","CRF-QoL","Inclusion Criteria:\n\nDiagnosed with chronic respiratory failure receiving any of:\n\n* Non-invasive ventilation\n* Prolonged mechanical ventilation\n* Mechanical insufflation-exsufflation therapy\n\nExclusion Criteria:\n\n* Aged \\\u003C18\n* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol",{"count":267,"type":21},200,"To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.",[270,271,157,272],"Chronic Obstructive Pulmonary Disease","Respiratory Failure","Ventilatory Failure",{"date":135,"type":37},{"date":275,"type":37},"2019-12-19",{"date":277,"type":21},"2026-12-31",{"name":43,"class":44},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":93,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":294,"locationsCount":81},"100375032","optimisation-of-mechanical-insufflationexsufflation-100375032","NCT04163198","Optimisation of Mechanical Insufflation:Exsufflation","Investigating Methods to Improve Secretion Clearance Using Mechanical Insufflation:Exsufflation in Patients With Neuromuscular Disease.","MIE2","Inclusion Criteria:\n\n* Stable or slowly progressive neuromuscular disease\n* Respiratory muscle weakness (FVC \\\u003C60%, snip \\\u003C60%, sleep disordered breathing)\n* Clinical evidence of respiratory secretions or cough peak expiratory flow \\\u003C270 and history of lower respiratory tract infection\n* Documented clinical stability by supervising clinician\n\nExclusion Criteria:\n\n* Rapidly progressive neuromuscular disease (such as motor neuron disease)\n* Decompensated respiratory failure (pH \\\u003C 7.35)\n* Pregnancy\n* Aged \\\u003C18\n* Change in ventilator settings in preceding 4 weeks\n* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol",{"count":54,"type":21},[95],"Patients with neuromuscular diseases (NMD) can suffer from a range of respiratory problems due to respiratory muscle weakness. Cough muscle weakness means secretion clearance from the airways can be problematic, a source of infection, and importantly a cause of death, in this patient group. Therefore, these patients are often supported with devices to aid clearance, such as mechanical insufflation-exsufflation (MIE). Although evidence supports the use of these devices, the optimal technique or settings on the device are not clear. Increasingly, higher pressures are used during MIE and recent work has demonstrated that there may be a physiological benefit to this. However, higher pressures increase the risk of causing lung collapse and may cause detriment to blood flow back to the heart, which is important as NMD patients frequently have concurrent heart muscle weakness. Further, recent work has demonstrated that higher pressures can cause closure of the throat, which is counter-productive in secretion clearance.\n\nThe overall aim of this study is to investigate methods to manipulate MIE to improve secretion clearance in patients with NMD. The questions it seeks to answer are:\n\n(i) how can we maximally improve lung recruitment during inspiration, whilst maintaining patient comfort and lower pressures (ii) what is the smallest pressure difference required in expiration to achieve an improvement in cough (iii) do these proposed changes to MIE also cause throat closure (iv) what factors do patients believe contribute to their adherence to MIE therapy?\n\nPatients with slowly progressive or stable neuromuscular diseases will be included in the study. Participation will involve two visits to the Lane Fox Respiratory Unit, each lasting approximately four hours. Patients will be recruited from specialist neuromuscular respiratory clinics by their clinical teams.",[157],{"date":135,"type":37},{"date":275,"type":37},{"date":41,"type":21},{"name":43,"class":44},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":90,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":81},"100640063","exploring-lived-experiences-of-families-of-children-with-spinal-muscular-atrophysma-type-1-regarding-feeding-and-communication-100640063","NCT07596277","Exploring Lived Experiences of Families of Children With Spinal Muscular Atrophy(SMA) Type 1 Regarding Feeding and Communication","Lived Experiences of Families of Children With Spinal Muscular Atrophy Type 1: A Qualitative Investigation Into Feeding and Communication","Inclusion Criteria:\n\n* Parents\u002Fguardians of children with a diagnosis of SMA1 who have received any one or more disease modifying therapies\\[CE7.1\\]\\[BA7.2\\]\\[AB7.3\\]\n* Participants need to be able to carry out interview in English In addition to parents, grandparents or other relatives with full parental responsibility will be included\n\nExclusion Criteria:\n\n* Parents\u002Fcarers who require an interpreter will not be included within the study for reasons of time and cost and because parents may feel less able to be open and honest when communicating with the researcher through a third party.\n* Primary carer who is a foster carer or corporate parent (i.e. a looked after child) as they are not likely to have the same decision-making 'freedoms'.",{"count":303,"type":21},15,"Spinal Muscular Atrophy Type 1 (SMA )Type 1 is a severe, early-onset neuromuscular condition that typically leads to profound weakness and impaired bulbar function-affecting swallowing, feeding, speech, and airway protection. Historically, bulbar decline contributed significantly to early morbidity and mortality.\n\nThe advent of disease-modifying therapies (DMTs) such as nusinersen, zolgensma and risdiplam (also known as Spinraza, Zolgensma, and Evrysdi) sinersinhas altered the clinical course of SMA Type 1, with emerging evidence of motor improvement and increased survival. However, the impact of these therapies on bulbar function remains poorly understood, and standardised tools for its assessment are lacking.\n\nQualitative research which uses interviews with parents and carers offers an opportunity to capture nuanced caregiver perspectives, identify meaningful functional outcomes, and explore daily lived experiences in a way quantitative tools currently cannot.\n\nThis study will investigate the lived experiences of families managing feeding and communication in children with SMA Type 1.\n\nThe research will also aim to\n\n1 Identify emotional, social issues experienced by families and practical support needs related to feeding and communication.\n\n2\\. Provide insights that can inform healthcare interventions and support",[306],"Spinal Muscular Atrophy 1",[306,308,309,310,311,312,313],"Bulbar function","eating and drinking","dysphagia","Communication","speech","language","2026-05-29",{"date":316,"type":37},"2026-06-02",{"date":318,"type":21},"2026-06-19",{"date":320,"type":21},"2026-11-01",{"name":43,"class":44},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":330,"minAge":90,"maxAge":173,"enrollmentInfo":331,"targetDuration":4,"studyType":93,"phases":333,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":164},"100472609","the-lisa-lactoferrin-instead-of-antibioticsantifungals-feasibility-study-100472609","NCT05434104","The LISA (Lactoferrin InStead of Antibiotics\u002FAntifungals) Feasibility Study","Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic\u002FAntifungal Tablets for Women With Bacterial Vaginosis or Thrush?","LISA","Inclusion Criteria:\n\n* Aged 16-49 years\n\n  * Having periods (apart from women with a Mirena IUCD or polycystic ovary syndrome)\n  * Ability to consent\n  * Clinical diagnosis of BV or thrush confirmed on Gram stain\n  * Willing to be randomised to vaginal lactoferrin pessaries or oral antibiotics\u002Fantifungals\n  * Agrees to provide vaginal samples at home and post\u002Fdeliver them back to the research team.\n  * Agrees to avoid douching during the study (as this can flush out lactobacilli needed for a healthy microbiome).\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Currently has chlamydia, gonorrhoea or trichomonas (as treatment for these would affect the results).\n* Known allergy to metronidazole or azoles\n* Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)","FEMALE",{"count":332,"type":21},114,[95],"Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush\u002Fcandida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and quality of life, and may need repeated courses of treatment. But some women prefer not to keep taking antibiotics which can have side effects and encourage the growth of resistant superbugs.\n\nLactoferrin is a prebiotic protein derived from cow's milk. Women also have naturally occurring lactoferrin in their vagina where it helps to prevent infections and encourage the growth of healthy bacteria. Recent research suggests lactoferrin may be an effective treatment for BV and thrush, but this needs to be confirmed.\n\nAim To see if it is feasible to conduct a future trial to prove whether lactoferrin vaginal pessaries are an acceptable, effective and cost-effective alternative to antibiotic tablets for women with BV or thrush.\n\nMethods The investigators will recruit a total of 57 women with BV and 57 with thrush from two sexual health clinics and a general practice. Women will be asked to provide self-taken vaginal samples with a cotton bud, and to complete a confidential sexual-health questionnaire. Then the women will be divided into two groups. One group will be given lactoferrin vaginal pessaries to use every night for 3-weeks. The other group will be given antibiotic\u002Fantifungal tablets. All women will be asked to provide repeat vaginal samples at home and text us about any symptoms to see if the treatment works, if the infection comes back and if they would like antibiotics. After 3 and 12-weeks all women will be invited back for a check-up.\n\nOutcome measures:\n\n* Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with 15-20 women\n* Recruitment and follow-up rates\n* Cost of lactoferrin treatment\n* The percentage of women who report their symptoms have resolved after a week\n* How quickly infections clear or recur - from analysis of samples\n\nPatient benefit:\n\nIf this study leads to a trial showing vaginal lactoferrin is an acceptable and effective alternative to antibiotics, this could help relieve symptoms, prevent antimicrobial resistance and save NHS costs.",[336,337],"Bacterial Vaginosis","Candida Vaginal",[339,340],"lactoferrin","prebiotic","2026-05-27",{"date":314,"type":37},{"date":344,"type":37},"2026-04-16",{"date":346,"type":21},"2027-12",{"name":43,"class":44},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":93,"phases":358,"briefSummary":359,"conditions":360,"keywords":369,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":81},"100640195","feasibility-of-protocolised-analgosedation-in-ecmo-100640195","NCT07580781","Feasibility of Protocolised Analgosedation in ECMO","Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients","ECMO-SED","Inclusion Criteria:\n\n* Aged 18 years and older\n* Receiving IV continuous infusions of analgosedation medication\n* Receiving ECMO treatment\n\nExclusion Criteria:\n\n* There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.",{"count":357,"type":21},60,[95],"Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\nTo see whether it is possible to run a trial that compares using a sedation protocol against usual care.\n\nDesign\u002Fmethods:\n\nThirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[361,362,363,364,365,366,367,368],"Intensive Care (ICU)","Respiratory Distress Syndrome (RDS)","Sedation and Analgesia","Extracorporeal Membrane Oxygenation","Sedation for Mechanical Ventilation","Cardiogenic Shock","Opioid Analgesia","Analgesia",[370,371,372,373,374,375,376,377,378,379,380,381],"extracorporeal membrane oxygenation","sedation","opioid","sedative","analgosedation","mechanical ventilation","ECMO","ICU","Intensive Care Unit","Critical Care","sedation protocol","analgesia","2026-05-05",{"date":384,"type":37},"2026-05-12",{"date":386,"type":21},"2026-09-01",{"date":388,"type":21},"2027-08-31",{"name":43,"class":44},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":354,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":400,"conditions":401,"keywords":404,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":81},"100595479","improving-sedation-practice-in-critically-ill-adult-patients-using-a-co-designed-sedation-protocol-100595479","NCT07032987","Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol","Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol","Stage 1 (multi-centre observational study):\n\nInclusion Criteria:\n\n1. Aged 18 years and older.\n2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and\u002For propofol).\n3. Receiving ECMO for moderate to severe respiratory failure (PaO2\u002FFiO2 (P\u002FF) ratio \\\u003C20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.\n4. Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P\u002FF ratio \\\u003C 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).\n\nExclusion Criteria:\n\n1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.\n2. Withdrawal of life-sustaining treatment in the next 24 hours.\n\nStage 2 (mixed methods study):\n\nInclusion Criteria:\n\n1. Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).\n2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.\n3. Family members of ECMO survivors, whose relative is no longer hospitalised.\n\nExclusion Criteria:\n\n1. ECMO survivors currently receiving treatment in hospital.\n2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).\n3. ECMO survivors who cannot communicate in English.\n4. Non-ECMO survivors and family members.","100 Years",{"count":399,"type":21},120,"Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\n* To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients.\n* To develop a sedation protocol for ECMO patients with input from patients, their family, and staff.\n\nDesign\u002Fmethods:\n\nStudy 1:\n\nThe investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2.\n\nStudy 2:\n\nThe investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[402,362,363,403,365,366,367,368],"Intensive Care Medicine","ExtraCorporeal Membrane Oxygenation (ECMO)",[370,371,372,405,374,375,376,377,378,379,380,381],"sedatives",{"date":407,"type":37},"2026-05-08",{"date":409,"type":37},"2025-11-24",{"date":388,"type":21},{"name":43,"class":44},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":90,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100634854","host-response-and-pathogen-genomics-in-childhood-respiratory-infection-100634854","NCT07545096","Host Response and Pathogen Genomics in Childhood Respiratory Infection","Observational Study Integrating Host Response Biomarkers With Pathogen Genomics for Precision Diagnosis in Children With Severe Respiratory Infection","INTERACT","Inclusion Criteria:\n\n* Admission to PICU and intubated and ventilated (including via tracheostomy)\n* Possible or proven lower respiratory tract infection\n\nExclusion Criteria:\n\n* Imminent death or palliative care pathway planned",{"count":421,"type":21},50,"A major challenge in children's infections is that it is difficult to work out which bug is making them unwell. Tests can find the bugs that are present though there can be more than one. Some bugs may just be bystanders and not actually making the child sick. Children still receive antibiotics because it is not always clear that they don't need them.\n\nThis project explores whether measuring how the body is reacting to the bugs gives precise information about which bug is actually making them sick. It will investigate children in intensive care who are suspected of having a chest infection.\n\nThis study uses a novel technology called \"metagenomics\" to detect any bacteria or viruses in the lung. Alongside this, investigators will measure how the lungs respond to the bugs through further tests of cells and proteins collected from the lung fluid. This fluid will be tested to see if the response is due to bacteria or viruses.\n\nCollecting lung fluid samples requires that children are sedated and intubated, having a breathing tube in place. This means that only children intubated in intensive care are eligible. Extra samples of lung fluid and blood will be collected when being taken for routine clinical care.\n\nIf these tests work, they have the potential to give rapid and accurate information about what type of infection is taking place in the lung. This means the correct antibiotics can be given to children who need them and avoid the harms of giving them to children who do not. This can reduce cost, improve patient outcomes and help limit the development of antibiotic resistance.",[424],"Pneumonia","2026-04-15",{"date":427,"type":37},"2026-04-22",{"date":429,"type":21},"2026-05",{"date":431,"type":21},"2027-03",{"name":43,"class":44},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":52,"sex":17,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":81},"100633684","symptoms-of-anxiety-andor-depression-and-sdm-in-older-patients-with-clti-100633684","NCT07529886","Symptoms of Anxiety and\u002For Depression and SDM in Older Patients With CLTI","Symptoms of Anxiety and\u002For Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)","Inclusion Criteria:\n\n* Patients\n\n  * Aged ≥65 years old\n  * CLTI\n  * Active symptoms of anxiety or depression (clinician concern)\n* Carers\n\n  o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression\n* Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI\n\nExclusion Criteria:\n\n* Patients\n\n  * Palliative - death anticipated within one month\n  * Clinical and research team identify as lacking capacity to participate\n* Carers\n\n  o Clinical and research team identify as lacking capacity to participate\n* Staff o Not providing care for older people with CLTI","65 Years",{"count":54,"type":21},"Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes.\n\nSurgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life.\n\nShared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.",[444,445,446],"Critical Limb Threatening Ischaemia","Depression Disorder","Anxiety",[448,449,450,451,452],"Shared decision making","Perioperative medicine","Geriatrics","Mental health problems","Vascular surgery","2026-04-14",{"date":455,"type":37},"2026-04-17",{"date":457,"type":21},"2026-06",{"date":459,"type":21},"2026-12",{"name":43,"class":44},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":81},"100627861","mechanisms-of-atrial-pathoelectrophysiology-in-hcm-100627861","NCT07454135","Mechanisms of Atrial Pathoelectrophysiology in HCM","MAP HCM","Inclusion Criteria:\n\n* Paroxysmal or persistent atrial fibrillation\n* Diagnosis of hypertrophic cardiomyopathy\n* Patient planning to proceed to atrial fibrillation ablation following clinical consultation\n* Age 18-80 years\n* Able and willing to provide written informed consent\n* Able and willing to comply with study follow up requirements\n\nExclusion Criteria:\n\n* Any clinical contra-indication to ablation\n* Any disease limiting life expectancy to \\\u003C1 year\n* Potential participant currently pregnant or breast feeding\n* Contraindication to MRI including renal dysfunction (eGFR\\\u003C30ml\u002Fmin)\n* Unable to understand verbal or written explanations given in English",{"count":469,"type":21},40,"This study aims to learn why atrial fibrillation (AF), a type of irregular heartbeat, happens more often and is harder to treat in people with hypertrophic cardiomyopathy (HCM). HCM is an inherited condition where the heart muscle is thicker than usual.\n\nResearchers will study electrical signals from the heart and advanced heart imaging. By doing this, they hope to better understand how AF behaves in people with HCM and why treatments may not work as well for them.\n\nThe information from this study may help improve future treatments for people who have both HCM and AF.",[472,473],"Hypertrophic Cardiomyopathy (HCM)","Atrial Fibrillation (AF)",[475,476],"hypertrophic cardiomyopathy","atrial fibrillation","2026-03-31",{"date":479,"type":37},"2026-04-06",{"date":481,"type":21},"2026-03-08",{"date":483,"type":21},"2027-09-30",{"name":43,"class":44},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":493,"maxAge":90,"enrollmentInfo":494,"targetDuration":4,"studyType":93,"phases":496,"briefSummary":497,"conditions":498,"keywords":503,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},"100501383","bears-training-package-to-maximise-hearing-abilities-in-older-children-and-teenagers-with-bilateral-cochlear-implants-100501383","NCT05808543","BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants","A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants","BEARS","Inclusion Criteria:\n\n1. Participant is a simultaneous or sequential bilateral cochlear implant user\\*, who either has:\n\n   1. Congenital severe\u002Fprofound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.\n   2. Progressive or acquired severe\u002Fprofound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \\*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)\n2. Participant has stable programmes (defined as no longer using progressive programmes to work through).\n3. Participant has had at least two usual care checks\u002Fclinical appointments with stable aided levels (+\u002F- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.\n4. Participant is aged 8-16 years, inclusive.\n\nExclusion Criteria:\n\n1. Participant (or parent\u002Flegal representative) does not speak\u002Funderstand English sufficiently to undertake assessments.\n2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.\n3. Participant has a comorbid condition impacting ability to participate in the intervention and\u002For outcome assessment.\n4. Participant has an audiological profile impacting ability to participate in the intervention and\u002For outcome assessments.\n5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.\n6. Participant is currently or anticipated to receive treatment and\u002For intervention that may affect hearing outcomes or adapt implant settings\u002Fprogramming.\n7. Participant is refusing to consent to trial activities\u002Fprotocol.\n8. Participant is awaiting reimplantation following device failure or infection.\n9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month).\n10. Participant is a fulltime boarder at a boarding school\n11. Participant has unresolvable issues found in device checks that render one of the implants unusable.\n12. Participant is a female that is pregnant.\n13. Participant has a diagnosis of epilepsy or history of seizures of any kind.","8 Years",{"count":495,"type":21},272,[95],"The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants.\n\nThe participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.",[499,500,501,502],"Hearing Loss, Sensorineural","Hearing Loss","Deafness","Hearing Impaired Children and Adolescents",[504,505,506,507,508,509,510,511],"Cochlear Implant","Virtual Reality","Children","Teenagers","Deaf","Bilateral","Training","Rehabilitation","2026-03-26",{"date":514,"type":37},"2026-04-01",{"date":516,"type":37},"2023-07-27",{"date":518,"type":21},"2026-10-31",{"name":43,"class":44},13,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":93,"phases":530,"briefSummary":531,"conditions":532,"keywords":535,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":81},"100627373","wisdom-uk-low-dose-intensity-versus-standard-dose-intensity-crrt-in-critically-ill-patients-100627373","NCT07447791","WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients","WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity Continuous Renal Replacement Therapy in Critically Ill Patients: a Randomized Trial","WISDOM UK","Inclusion Criteria:\n\n* age ≥ 18 years\n* patient weight ≥ 55 kg\n* plan to start CRRT or within 24 hours of having started CRRT for AKI\n* expected to survive and receive CRRT for a duration of ≥ 48 hours\n\nExclusion Criteria:\n\n* indication for sustained higher dose-intensity CRRT\n* end-stage kidney disease receiving maintenance dialysis\n* previous receipt of RRT for AKI during the current hospitalization\n* inability to comply with the requirements of the study protocol",{"count":123,"type":21},[95],"Acute kidney injury is a potentially life threatening condition which affects 1 in 2 patients in the Intensive Care Unit (ICU). Patients often need dialysis treatment, also called renal replacement therapy. Renal replacement therapy is a treatment that removes toxins and excess fluid from the blood stream. It consists of having a small plastic catheter in a vein in the neck or in the groin through which blood flows through a dialysis machine and is cleansed and excess water is removed. The cleansed blood is then returned to the patient via the same catheter.\n\nOne of the major areas of uncertainty for doctors in the ICU is \"What is the right intensity of renal replacement therapy for patients with acute kidney injury?\" A higher intensity indeed removes more toxins but also removes other substances in the blood, including vitamins, nutrients and important medications. The current usual dose is around 25 ml\u002Fkg\u002Fhr but clinical practice in the UK is very variable and some patients routinely receive higher doses and some get lower doses. Data from large databases worldwide have suggested that a lower dose is safe and effective and may potentially allow the kidneys to recover faster but confirmation is lacking.\n\nIn this study, the investigators investigate whether renal replacement therapy at a lower intensity is as effective and safe as currently used doses. Participants will be randomised to receiving renal replacement therapy at usual or lower intensity. There will be no change to any other aspects of treatment.\n\nThe results will inform the investigators whether the study protocol is feasible and how best to design a future larger research study.",[533,534],"Acute Kidney Injury (Nontraumatic)","Dialysis; Complications",[536,537,538],"renal replacement therapy","dose","acute kidney injury","2026-03-03",{"date":541,"type":37},"2026-03-05",{"date":543,"type":37},"2025-02-15",{"date":545,"type":21},"2027-03-30",{"name":43,"class":44},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":555,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":93,"phases":557,"briefSummary":558,"conditions":559,"keywords":568,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":4},"100625231","older-kidney-patient-optimisation-pretransplant-100625231","NCT07419945","Older Kidney Patient Optimisation Pretransplant","Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)","OK-POP","Inclusion Criteria:\n\n* Adults aged 60 years or older\n* Attending Guy's and St Thomas' (GSTT) Nephrology services\n* Diagnosed with Chronic Kidney Disease (CKD) Stage 5\n\nEither:\n\n* Pre-dialysis, or\n* Receiving dialysis (in-centre haemodialysis, peritoneal dialysis, or home haemodialysis)\n* Referred to the kidney transplant surgical clinic for assessment of suitability for kidney transplantation (pre-transplant evaluation)\n\nExclusion Criteria:\n\n* Adults aged under 60 years\n* Patients currently attending the Nephrology Supportive Care service at GSTT","60 Years",{"count":421,"type":21},[95],"The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are:\n\nIs it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease?\n\nWhat is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty?\n\nResearchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone.\n\nParticipants will:\n\nContinue with their usual transplant assessment process\n\nIf randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)",[560,561,562,563,564,565,566,567],"Kidney Disease","Kidney Failure","Frailty","Cognitive Impairment","Multimorbidity","End Stage Kidney Disease (ESRD)","Kidney Transplant","Health Inequity",[569,570,571,572,573,574],"kidney transplant","frailty","multimorbidity","cognitive impairment","end stage kidney disease","health inequality","2026-02-12",{"date":577,"type":37},"2026-02-19",{"date":579,"type":21},"2026-02-02",{"date":581,"type":21},"2028-02-02",{"name":43,"class":44},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":93,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":604,"locationsCount":81},"100413522","rate-or-rhythm-control-in-crt-the-rhythmic-study-100413522","NCT04664686","Rate or Rhythm Control in CRT: the RHYTHMIC Study","RHYTHMIC","Inclusion Criteria:\n\n* Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.\n* QRS duration \\>120ms on surface ECG, severe left ventricular systolic impairment (EF≤35%) and clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV) at time of CRT implant or upgrade\n* Successful CRT implant or upgrade including atrial lead\n* Biventricular pacing percentage \\\u003C95% secondary to atrial fibrillation at least 3 months post implant or upgrade\n* Clinically indicated for AV node ablation\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year\n* Presence of atrial or ventricular thrombus\n* Permanent atrial fibrillation\n* Mechanical aortic valve replacement\n* Severe peripheral vascular disease\n* Female participants who are pregnant, lactating or planning pregnancy during the course of the study.\n* Participation in other studies with active treatment \u002F investigational arm","85 Years",{"count":592,"type":21},70,[95],"70 patients with heart failure, AF and CRT with BiV\\\u003C95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment.",[596,597],"Atrial Fibrillation","Heart Failure","2026-01-23",{"date":600,"type":37},"2026-01-26",{"date":602,"type":37},"2021-10-19",{"date":483,"type":21},{"name":43,"class":44},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":330,"minAge":90,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":93,"phases":613,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100621603","lifting-the-impacted-fetal-head-the-fetal-pillow-and-tydeman-tube-trial-100621603","NCT07372768","Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial","LIFT","Inclusion Criteria:\n\n* Undergoing caesarean section at full dilataion for fetal pillow arm, or caesarean section at 7 or more centimetres dilated for the tydeman tube arm\n* Singleton pregnancy\n* Cephalic presentation\n\nExclusion Criteria:\n\n* Allergy to silicone rubber\n* Major congenital abnormalities\n* Major anomaly of the fetal head (i.e. large encephalocele)\n* Intrauterine death\n* Suspected chorioamnionitis\n* Active genital infection inc. Herpes Simplex Virus\n* Cervical dilatation \\\u003C10cm for fetal pillow arm and \\\u003C7cm for tydeman tube arm\n* Gestational age \\\u003C37 weeks\n* non-cephalic presentation",{"count":92,"type":21},[95],"A single centre prospective observational comparison trial to compare the Tydeman Tube and Fetal Pillow, to aid delivery of the impacted fetal head at full dilatation caesarean section, and to evaluate the use of the Tydeman Tube at 7-9cm.",[616,617],"Impacted Fetal Head","Full Dilatation Caesarean Section",[619,620,621,622,623],"Impacted fetal head","Caesarean section","Full dilatation caesarean section","Tydeman Tube","Fetal Pillow","2026-01-20",{"date":626,"type":37},"2026-01-28",{"date":628,"type":21},"2026-01",{"date":630,"type":21},"2027-04",{"name":43,"class":44},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":640,"conditions":641,"keywords":643,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":81},"100616763","improving-genetic-medicine-for-ethnic-minority-groups-100616763","NCT07309835","Improving Genetic Medicine for Ethnic Minority Groups","Capturing Ethnic Minority Experiences of Genomic Pathways to Understand What Changes Are Needed to Promote Greater Equity Within the Genomic Medicine Service.","Inclusion Criteria:\n\n* Adults\n* Have capacity to consent to take part\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Affected by a serious mental health condition\n* Learning disabilities",{"count":20,"type":21},"A key aim of the nationally commissioned Genomic Medicine Service (GMS) in England is to encourage equity of access between different patient groups, however, there is evidence to suggest that it is being under-utilised by ethnic minority groups. The aim of this study is to explore how ethnic minority populations interact with the GMS and to identify changes that would promote equity within those services.\n\nThis is a mixed-methods study using interviews and group discussions with lay people, community organisers and charity workers, people who have had direct or indirect contact with the genomic medicine service and professionals within the service. By including potential service users, service users and professionals in this work and allowing people to share their experiences in whatever method feels most comfortable to them, we aim to get a broad understanding of the lived experience of everyone involved in these pathways which will be key to gaining a holistic understanding of how they are working in real world settings.\n\nThe primary outcome measure will be an increased understanding of the experiences of people from ethnic minority groups navigating the genomic medicine space. The secondary outcome measure will be an increased understanding of how experiences differ across and between ethnic groups. We intend to use our insights to recommend structural changes which will improve utilisation of the genomic medicine service by patients from ethnic minority groups.",[642],"Genetic Testing",[644,645,646,647,648,649],"interview","ethnic minority","mixed method","qualitative","genetic testing","genomic testing","2025-12-16",{"date":652,"type":37},"2025-12-30",{"date":654,"type":21},"2026-01-30",{"date":656,"type":21},"2031-01-30",{"name":43,"class":44},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":93,"phases":666,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":677},"100607814","optimising-the-delivery-of-diabetes-distress-informed-care-for-its-prevention-detection-and-management-in-adults-with-type-1-diabetes-a-feasibility-study-d-stress-study-100607814","NCT07193446","Optimising the Delivery of Diabetes Distress Informed Care for Its Prevention, Detection, and Management in Adults With Type 1 Diabetes: a Feasibility Study (D-stress Study)","Inclusion Criteria:\n\nAdults with type 1 diabetes\n\n* People aged 18 years old and older\n* With a T1DM diagnosis of more than one year\n* Who used a Continuous Glucose Monitoring device 3 months prior to trial entry\n\nHealth care professionals\n\n* Members of the multidisciplinary diabetes team\n* Who would like and be able to undertake training in Enhanced Usual Care (EUC)\n\nFamily or friend\n\n* People aged 18 years or older\n* Is involved with the care of the participant\n* The participant has consented to the family member or friend to be involved in the study\n\nREDUCE Facilitators\n\n• Eligibility as per the role specification in Section 6.2.2 of study Protocol\n\nExclusion Criteria:\n\nAdults with type 1 diabetes\n\n* Exclusion criteria will include those adults diagnosed less than one year ago. This is because the first 12 months following a diagnosis of T1DM is a period of unique stress due to the diagnosis, the acute onset, and requirement to learn complex new skills. Additionally, due to the honeymoon period, which can typically last up to a year, there is variety in the physiological trajectory which might have an impact that would be difficult to measure and account for in this study(Sokołowska, Chobot et al. 2016).\n* Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may risk confounding the trial findings\n* Exclusion of adults with current mental health diagnoses with current symptoms (e.g. psychosis or substance abuse or severe depression), will be evaluated and determined on a case-by-case basis by clinical care teams.\n\nHealth care professionals • People who are unwilling or unable to take on additional workload associated with D-stress e-learning and delivery of Enhanced Usual Care.\n\nFamily or friend\n\n• Participant with type 1 diabetes has not given consent for a family member or friend to participate in the study\n\nREDUCE Facilitators\n\n* • Professional accreditation with one of the following professional bodies: Nursing \\& Midwifery Council, Health \\& Care Professionals Council, British Association for Counselling \\& Psychotherapy, and UK Council for Psychotherapy.\n* Professional or personal understanding of Type 1 diabetes\n* Professional or personal understanding of NHS diabetes care and guidelines\n* Professional or personal understanding of diabetes distress\n* Professional understanding of mental and emotional health\n* Professional experience of in-person and\u002For online group facilitation especially in managing diverse needs within a group and the expression of strong emotions\n* Willingness to be a research participant",{"count":665,"type":21},110,[95],"Up to one in two adults with type 1 diabetes find living with and managing diabetes to be emotionally challenging. This 'emotional side' of diabetes - feeling worried, frustrated, overwhelmed, sad, burnt-out - is called diabetes distress. It affects people's quality of life and can hinder them from managing their diabetes as well as they can.\n\nIn the UK, the NHS needs to better understand how to best support people feeling emotionally burdened by diabetes. So, we have worked with diabetes distress specialists around the world to develop an NHS pathway to care for diabetes distress. This pathway to care involves training diabetes teams to recognise, assess and talk about diabetes distress at routine appointments. If people have a high diabetes distress level, they may be able to take part in an online group program to help them manage their type 1 diabetes and emotions. The feasibility study will test this pathway to care with people with type 1 diabetes in the NHS setting.",[669],"Diabetes Type 1","2025-11-26",{"date":672,"type":37},"2025-12-04",{"date":674,"type":37},"2025-10-31",{"date":386,"type":21},{"name":43,"class":44},3,""]