[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Oxford\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":654},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,94,0,25,[9,47,71,100,126,148,187,213,234,252,275,299,332,358,379,405,439,467,492,525,545,566,587,612,634],{"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":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100631879","hope-groups-parenting-and-mental-health-among-refugees-in-the-middle-east-100631879",false,"NCT07506421","Hope Groups: Parenting and Mental Health Among Refugees in the Middle East","Hope Groups: A Small-Scale Randomised Controlled Trial Of Psychosocial And Parenting Support Groups For Palestinian Caregivers Affected By War In The Middle East","Inclusion Criteria:\n\n* Participant is living in one of our partner refugee camps.\n* Participant is a parent\u002Fcaregiver for one or more child (of any age).\n* Participant is over the age of 18.\n* Participant has high, medium, or low literacy. (Note: This is in order to use our Hope Groups programme guide. Our team is concerned that individuals with no literacy would need more audio files, rather than just a text-driven participant guide. If Hope Groups demonstrate effectiveness in this pilot, investigators will have focus groups with low-literacy participants, to create a future version which is suitable for people of all literacy backgrounds.)\n* Participant consents to participate in the study.","ALL","18 Years",{"count":20,"type":21},490,"ESTIMATED","INTERVENTIONAL",[24],"NA","This research is testing if 'Hope Groups' -- a psychosocial, mental health, parenting strengthening, and violence prevention support group program -- work to help Palestinian caregivers displaced by war.",[27,28],"Mental Health","Violence Against Children",[30,31,32,28,33],"War","Displacement","Parenting","Refugee","RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2025-02-05",{"date":42,"type":21},"2026-11-01",{"name":44,"class":45},"University of Oxford","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100642354","vrehab-sma-phase-12-100642354","NCT07578454","VRehab-SMA Phase 1.2","Virtual Targeted Rehabilitation for Patients With Spinal Muscular Atrophy: Phase 1.2: Proof-of-concept","Cohort 1 Inclusion Criteria:\n\n* Person with SMA\n\n  * A person living with genetically confirmed SMA aged from 12-18 years\n  * A good understanding of English or someone who can provide a good understanding of English for me to complete the survey\n  * A young person living with SMA from 12-15 years of age and who's caregiver\u002Flegal guardian gives consent\n  * A young person living with SMA from 16-18 years of age who provide their own consent\n\nCaregiver\u002F Legal Guardian\n\n* A caregiver (legal guardian) of child\u002Fyoung person living with SMA aged from 6-18 years old\n* A good understanding of English or someone who can provide a good understanding of English for me to complete the survey\n\nExclusion Criteria: No exclusion criteria for Cohort 1, other than meeting the inclusion criteria\n\nCohort 2 Inclusion Criteria:\n\nParticipant with SMA aged 6-10 years\n\n* Genetically confirmed SMA\n* A comprehensive understanding of English\n* Treated with any disease-modifying therapy post-symptomatically\n* Number of SMN2 copies available\n* Functional status available\n* Age: Participants between 6-10 years at Visit 1 (inclusion)\n* Parent(s)\u002Flegal guardian(s)\u002Fcaregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study\n\nParticipant with SMA aged 11-15 years\n\n* Genetically confirmed SMA\n* A comprehensive understanding of English\n* Treated with any disease-modifying therapy post-symptomatically\n* Number of SMN2 copies available\n* Functional status available\n* Age: Participants between 11-15 years at Visit 1 (inclusion)\n* Parent(s)\u002Flegal guardian(s)\u002Fcaregiver(s) able to provide written informed consent and child able to provide assent prior to participation in the study\n\nParticipant with SMA aged 16-18 years\n\n* Genetically confirmed SMA\n* A comprehensive understanding of English\n* Treated with any disease-modifying therapy post-symptomatically\n* Number of SMN2 copies available\n* Functional status available\n* Age: Participants between 16-18 years at Visit 1 (inclusion)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\nAny acute or chronic condition which, according to the investigator, significantly interferes with the use of the device (example: Upper limbs injuries interfering with technology, skin conditions preventing the use of electrodes, etc)","6 Years",{"count":56,"type":21},12,[24],"Spinal muscular atrophy is a genetic disorder characterized by progressive muscle weakness, severely impacting patients' motor abilities. Several disease modifying therapies have been developed to treat Spinal muscular atrophy which have led to new disease trajectories . According to standard of care guidelines, exercise programs should be designed and monitored by a physical therapist and should include exercises to improve daily life activities. Exercises should be adapted to each patient and can be prescribed with an optimal frequency in various ways. However, of patients with Spinal muscular atrophy, only 20% reported access to endurance exercises and only 6% to mixed exercises. This incompliance to standard of care guidelines is due to manpower limitation and difficulties in engaging with young and sometimes highly disabled children. Our group has been pioneering in developing the UK at-home individualised rehabilitation program. To address this challenge, the Investigators propose the development of an innovative, virtual targeted rehabilitation platform specifically designed for young patients with Spinal muscular atrophy. This technology aims to provide a patient-centric, at-home rehabilitation solution, enabling parents\u002Fcaregivers to facilitate daily exercises in a more accessible and enjoyable manner. This technology would constitute the first of its kind in Spinal muscular atrophy field, involving the integration of augmented electromyography signals and soft robotic haptic devices into a gamified virtual reality environment. By increasing the frequency and quality of exercise interventions at home, this technology has the potential to significantly address the critical unmet need for consistent rehabilitation. This technology will also serve as a clinical outcome measure for continuous home-based assessments of weaker and less functional population in place of hospital-based assessments.",[60],"Spinal Muscular Atrophy (SMA)",[62],"Spinal Muscular Atrophy","2026-06-09",{"date":65,"type":38},"2026-06-11",{"date":67,"type":38},"2026-05-27",{"date":69,"type":21},"2027-04",{"name":44,"class":45},{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100625468","a-remote-study-using-technology-to-assess-outcomes-in-dmd-100625468","NCT07423026","A Remote Study Using Technology to Assess Outcomes in DMD","TODDLER Study: Transforming Outcomes in Duchenne Muscular Dystrophy Using DigitaL Endpoints Remotely","TODDLER","Inclusion Criteria:\n\nParticipant with DMD:\n\n* Male\n* Aged 1-3 years old\n* Ambulant (walking 10m independently)\n* Genetically confirmed diagnosis of DMD\n* Parent(s)\u002Flegal guardian(s) able and willing to provide written informed consent for the child to participate in the study\n* Parent(s)\u002Flegal guardian(s) able and willing to participate in the study\n\nParent\u002Flegal guardian of participant with DMD:\n\n* Aged 18 years or more\n* Legal carer of the patient diagnosed with DMD\n* Willingness to follow study procedures and assist with remote assessments, as assessed by the research team\n* Willingness to sign the consent form\n* Ability to understand all the information with regards to the study, as assessed by the research team\n\nHealthy Control participant:\n\n* Male\n* Aged 1-3 years old\n* Ambulant (walking 10m independently)\n* Parent(s)\u002Flegal guardian\n\nExclusion Criteria:\n\nParticipant with DMD:\n\n* Limb surgery\u002Ftrauma (within 6 months)\n* Significant comorbid chronic or acute conditions affecting motor function (within 3 weeks)\n* Prematurity (born \\\u003C37 weeks' gestation)\n* Oral corticosteroids to treat DMD (before enrolment)\n* Enrolment in therapeutic clinical trials\n* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement)\n\nHealthy Control participant:\n\n* Limb surgery\u002Ftrauma (within 6 months)\n* Significant comorbid chronic condition affecting motor function\n* Significant acute condition affecting motor function (within 3weeks of enrolment)\n* Prematurity (born \\\u003C37 weeks' gestation)\n* Neurodevelopmental concerns or delay in acquisition of WHO developmental milestones.\n* Any comorbidity which could limit their ability to complete the study assessments (according to the investigator's clinical judgement).",true,"MALE","1 Year","3 Years",{"count":84,"type":21},60,"OBSERVATIONAL","Every year, 100 boys are born in the UK with a rare muscle disease called Duchenne muscular dystrophy. These boys cannot make an important muscle protein called dystrophin. They become weaker as they get older and lose the ability to walk as teenagers. This is a life-limiting condition. There is no cure, but medicines are being made that could help these boys make dystrophin. These medicines are most likely to work best in toddlers, before their muscles become damaged.\n\nThere is no way of testing these medicines in children under four. In older children, it is possible to measure how well and how quickly a child can do movements like sitting up, standing up, and running. Unfortunately, these tests are not suitable for toddlers as they often struggle to listen and do what they are asked to do. Tiredness and mood can also affect their scores. Luckily, there is a new way of testing how well children move. They can wear special watch-like devices on their ankles that record information about their steps as they go about their normal lives. This is a good way of testing how well a child walks. It is now used to test medicines in children over four years old. Our aim is to test whether this device works well in children under four.\n\nThis study will invite 30 boys with DMD (and their parent\u002Fcaregiver) and 30 boys without DMD aged 1-3 years old from across the country to join the study. There are no hospital visits. Children will receive the watch-like devices to wear for three blocks of 28-days over six months during their normal daily activities. At the start and end of the study, a physiotherapist will visit the homes of boys with DMD. They will check their movements using other tests. The investigators will find out 1) if young boys are happy to wear the device, 2) how it compares to other tests, and 3) if it can detect changes in walking ability.\n\nThis study could give us a way to test medicines in younger children. Wearable devices could cut down the travel and stress of tests for boys and their families. Children with learning or behavioural difficulties, and children living far from research centres could now also take part in studies of new medicines. This study could bring us a step closer to treating this life-limiting disease.",[88],"Duchenne Muscular Dystrophy (DMD)",[90,91,92],"DMD","Devices","children",{"date":94,"type":38},"2026-06-10",{"date":96,"type":21},"2026-06-24",{"date":98,"type":21},"2028-07-01",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100643532","gut-leakage-in-dengue-100643532","NCT07602920","Gut Leakage' in Dengue","Gut Leakage and Sonographic Abdominal Changes in Hospitalized Dengue Patients: an Observational Study","GLiD","Inclusion Criteria:\n\nDengue participants\n\n* Participant\u002F legally authorised representative willing and able to give informed consent for participation in the study.\n* Male or Female, adults ≥18 years\n* Diagnosed as a case of Dengue on the basis of clinical features and positive NS1 antigen and\u002For IgM dengue antibody\n* Hospitalized in medicine or dengue ward in Chittagong Medical College Hospital.\n* Enrolled within 24 hours of hospitalization.\n\nHealthy participants\n\n* Participant\u002F legally authorised representative willing and able to give informed consent for participation in the study.\n* Male or Female, adults ≥18 years\n* Clinically healthy with no acute or chronic illness\n* Attendant of a dengue patient (not a patient)\n\nExclusion Criteria:\n\nDengue participants\n\n* Unable to provide consent or participate in follow-up procedures\n* Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (\\\u003C3 months) major GI surgery.\n* Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.\n* Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.\n* Pregnancy\n\nHealthy participants\n\n* Unable to provide consent\n* Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (\\\u003C3 months) major GI surgery.\n* Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.\n* Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.\n* Pregnancy\n* History of current or recent dengue or other arbo viral infection",{"count":109,"type":21},190,"Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage.\n\nThis study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity.\n\nAbdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool\u002F rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.",[112,113,114,115,116,117],"Dengue","Dengue Hemorrhagic Fever","Intestinal Disease","Ascites","Dengue With Warning Signs","Gut Microbiome","NOT_YET_RECRUITING","2026-06-08",{"date":94,"type":38},{"date":122,"type":21},"2026-07-01",{"date":124,"type":21},"2028-01-31",{"name":44,"class":45},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100639246","inflammation-digital-biomarkers-validation-study-100639246","NCT07594054","Inflammation Digital Biomarkers Validation Study","IDBV: Inflammation Digital Biomarker Validation Study","IDBV","Inclusion Criteria:\n\nPreviously consented to take part in the HPOS study and have agreed to be contacted for future ethically approved studies.\n\nAdults with psoriasis with no diagnosis of PsA.\n\nHave a compatible smartphone\n\nHave a good command of local language\n\nExclusion Criteria:\n\nParticipants not consented into the HPOS study\n\nDo not have use of a compatible smartphone\n\nAre not willing to use the smartphone app.\n\nAdults with a pre-existing diagnosis of PsA",{"count":135,"type":21},3458,"HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. The study is led by a research team at University of Oxford and supported by a team at University College Dublin. This current study aims to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. The investigators want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. The HPOS study is currently recruiting\u002Fapproaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires include a 'screening questionnaire' to try to identify arthritis.\n\nAdults with psoriasis but without a pre-existing diagnosis of PsA are currently being recruited via clinics, national and international patient support organisations including those under the umbrella of EUROPSO, and media campaigns. Participants are recruited across Europe in the following countries: UK, Ireland, Italy, France, Spain, Denmark, Germany, Belgium, Netherlands, Sweden, Portugal, Greece, Norway, Switzerland, Poland and Romania. The University of Oxford is the sponsor for the study across all countries, but local regulations will be followed, and local ethical approval has been sought for each different country. Data is requested from participants every 6 months and they will be prompted by email.\n\nLikewise, the iPROLEPSIS consortium is a Horizon Europe funded consortium investigating digital biomarkers in PsA. In 2024, the consortium launched a study recruiting 600 patients with PsA across 4 counties, utilising digital biomarkers to identify disease flares. This includes the use of smartwatches, a mobile phone app and active video tests. This will allow us to develop algorithms to identify active disease.\n\nSimilar approaches are proposed for a study called the Inflammation Digital Biomarkers Study (IDBV) which will try to identify the onset of PsA in people living with psoriasis. Patients in HPOS who have given consent to be contacted about additional studies, will be offered the opportunity to join this study. They will complete an additional consent form and will download the miPROLEPSIS lite app to their mobile phone.\n\nThe Study app will passively collect data from the user's phone; participants do not need to perform any specific tasks apart from some initial configuration steps like logging in and connecting their wearables (Connecting a wearable is optional).\n\nThe investigators intend to run IDBV as a sub-study in HPOS and invite participants enrolled into the HPOS study who do not have a diagnosis of PsA.",[138,139],"Psoriatic Arthritis","Psoriasis (PsO)","2026-05-20",{"date":142,"type":38},"2026-05-22",{"date":144,"type":21},"2026-06",{"date":146,"type":21},"2027-12",{"name":44,"class":45},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":46},"100641020","probiotic-intake-and-perimenopausal-psychological-assessments-100641020","NCT07590999","Probiotic Intake and Perimenopausal Psychological Assessments","The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women","PIPPA","Inclusion Criteria:\n\n* Female at birth\n* You are aged 45-60 years and in perimenopause (determined by changes in menstrual bleeding patterns (such as changes in cycle length of 7 days or longer in either direction from what is normal for you), AND vasomotor symptoms (e.g., hot flushes and sweats) AND mild to moderate mood or cognitive disturbances, or joint and muscle pain over the previous 12 months)\n* You are willing and able to give informed consent for participation in the study\n* You are sufficiently fluent in English to understand and complete tasks\n* You are at least 12 months post-natal\n* Willing to withhold from having grapefruit juice\n\nExclusion Criteria:\n\n* Currently receive or seek treatment for any mental health condition\n* Have a BMI \\>=30 OR \\\u003C=18.5\n* Have lost or gained more than 10% of body weight in a short period (e.g., 6 months), as this can affect mood and cognition\n* Currently using hormonal contraception or have used hormonal contraception in the last 6 months\n* Have had gender reassignment surgery or gender-affirming hormone therapy\n* Had a head injury causing concussion or unconsciousness in the past 6 months\n* Participated in other studies that may influence mood, cognition, or gut health in the last three months\n* Are currently diagnosed with and\u002For treated for psychiatric or neurological disorders\n* Are on perimenopausal hormone replacement therapy (HRT) (e.g., estrogen, progesterone, testosterone) or other hormone-modulating medications (e.g., GLP-1 agonists, thyroxine replacement), as these can impact mood and cognitive functions\n* Currently use statins or have used statins in the last 6 months, as these may impact mood and cognitive functions\n* Participated in any other study with the same tasks in the last year\n* Currently use medications that influence cognition or mood, such as antidepressants, anxiolytics, antipsychotics, stimulants, mood-stabilizers, or cognitive-enhancing drugs\n* Have chronic or severe gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, celiac disease, or severe acid reflux; treatment with e.g., corticosteroids, antacids), as these conditions and treatments can affect the gut microbiota and immune responses differently from healthy individuals\n* Have a compromised immune system\n* Currently smoke, vape, or use any other nicotine products\n* Have a current diagnosis of cognitive impairment or neurodegenerative disorders (e.g., mild cognitive impairment, dementia), as these conditions could confound cognitive assessments.\n* Have severe medical conditions requiring ongoing medication that may independently affect cognition or mood (e.g., diabetes)\n* Currently or recently used antibiotics (last 3 months), as antibiotics may alter gut microbiota and interfere with probiotic effects\n* Currently or recently used probiotics or prebiotics or consumed fermented products (e.g., kimchi, kombucha, sauerkraut, kefir, etc.) on a regular basis (last 3 months), which might interfere with the study intervention\n* Have known allergies or intolerances to probiotics or components in the probiotic supplement.\n* Have substance abuse or dependence (e.g., alcohol, recreational drugs) that may affect mood and cognition.\n* Have Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (Long COVID)\n* Have had a hysterectomy\n* Are pregnant or lactating, as hormonal changes associated with these states could confound results.\n* Score of 20 or above on PHQ-9 depression questionnaire, indicating severe depression\n* Score of \\>1 on PHQ-9 suicidality item, indicating significant suicidality (as assessed by medical on-site professionals","FEMALE","45 Years","60 Years",{"count":160,"type":21},106,[24],"Recent evidence suggests multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum have been found to enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improve cognitive functions, such as memory and concentration, in healthy participants. By administering computer-based tasks, questionnaires and checking biological measures (cortisol, immune markers, blood metabolites, gut microbiota) using blood and faecal samples, this experimental medicine study aims to investigate whether a probiotic supplement has an effect on emotional processing and cognition in perimenopausal women. We also aim to study changes in gut bacteria from stool samples before and after taking the supplement to see if any microbiome changes are associated with any effects in emotional processing, cognitive function, and biological markers.",[164,165,166,167],"Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations","Perimenopause","Perimenopause-Related Depression","Perimenopausal Women",[169,170,171,172,173,174,175,176,177,178],"perimenopause","menopause","gut microbiome and perimenopause","cognition and perimenopause","emotional processing and perimenopause","mood and perimenopause","gut microbiome and cognition","probiotics","probiotic","gut microbiome","2026-05-12",{"date":181,"type":38},"2026-05-15",{"date":183,"type":38},"2025-11-12",{"date":185,"type":21},"2027-06-30",{"name":44,"class":45},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":79,"sex":17,"minAge":4,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":46},"100634693","an-international-federated-model-for-wearable-derived-remote-longitudinal-motor-monitoring-in-young-children-with-spinal-muscular-atrophy-compared-with-healthy-controls-active-nbs-study-uk-100634693","NCT07543003","An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)","A Prospective, Longitudinal and Decentralised Study Investigating the Motor Development of Patients With Spinal Muscular Atrophy Identified by Newborn Screening Age 4 Years and Below: Active-NBS UK.","Active-NBS UK","Inclusion criteria (Test cohort):\n\n1. Genetically confirmed SMA and number of SMN2 copies available\n2. a. Patients identified by NBS and treated with disease modifying therapy (DMT)\n\n(2)a,i 4 copies or more of SMN2 and not treated with DMT\n\n(2)a,ii less than 4 copies of SMN2 and not treated with DMT\n\nor\n\n(2)b. Patients diagnosed due to a sibling or alternative means\n\n(2)b,i 4 copies or more of SMN2 and not treated with DMT\n\n(2)b,ii less than 4 copies of SMN2 and not treated with DMT\n\n(3)Patients between 4 months and below 4 years at baseline. Inclusion of patients can be before 4 months of age\n\n(4)Parent(s)\u002Flegal guardian(s) able to provide written informed consent prior to the patient's participation in the study\n\n(5)Male or female\n\nExclusion Criteria (Test cohort):\n\n1. Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and\u002For the motor evolution\n2. Currently enrolled in an experimental treatment study\n\nInclusion criteria (Control):\n\n1. Typically developing child\n2. Participant between 6 months and 4 years at inclusion\n3. Parent(s)\u002Flegal guardian(s) able to provide written informed consent prior to the participation in the study\n4. Male or female\n\nExclusion criteria (Control):\n\n(1)Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and\u002For the motor evolution","4 Years",{"count":197,"type":21},90,"Active-NBS is a study to evaluate the muscle development of patients with spinal muscular atrophy (SMA) who are diagnosed at birth.\n\nMedicines have become available in the last decade, and many patients are treated very early. Treatments are most effective if used before the patient develops symptoms. However, some patients may show symptoms by the time they receive treatment. This means that even with early diagnosis, they might still develop muscle weakness despite treatment. The investigators want to see when the movements of patients diagnosed at birth differ from normal development. This information will help identify the best time to give additional medicines currently being developed to support the muscle.\n\nThe investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home. The investigators aim to validate their outcomes for use in this age group. The wearable devices are called Syde and Motor Assessment of an Infant in a Jumpsuit (MAIJU).\n\nThey will be worn at regular intervals during the study and will not involve extra hospital visits for patients. The study will also recruit up to 30 healthy control participants and follow them for up to 30 months. This will help define normal development with use of the Syde device.\n\nActive-NBS will be conducted in the UK and internationally using a federated data model. Collaborative sites will collect harmonised data in accordance with the Active-NBS protocol, with data integration and oversight managed by the University of Oxford. International sites may contact the Oxford study team to establish collaboration.",[60],[201,202,203,204],"Spinal muscular atrophy","Newborn screening","Motricity","Development","2026-05-06",{"date":207,"type":38},"2026-05-11",{"date":209,"type":38},"2026-05-01",{"date":211,"type":21},"2029-07",{"name":44,"class":45},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},"100514058","blood-lipid-responses-to-diet-macronutrients-100514058","NCT05973539","Blood Lipid Responses to Diet Macronutrients","Investigating Blood Lipid Responses to Dietary Macronutrient Content","BoLD","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged ≥18 to ≤65 years\n* Body mass index (BMI) ≥19 to ≤35 kg\u002Fm2\n* No medical condition or relevant drug therapy that is known to affect the liver, adipose tissue, or cardiac metabolism.\n* Weight stable for the previous 3 months\n\nExclusion Criteria:\n\n* Aged \\\u003C18 or \\>65 years\n* BMI \\\u003C19 or \\>35 kg\u002Fm2\n* A blood haemoglobin \\\u003C135 mg\u002FdL for men and \\\u003C120 mg\u002FdL for women\n* Donated (or lost) ≥250 mL of blood in the previous two months\n* On a weight loss diet or decreased their body weight by \\>5% in the previous 3 months\n* Currently adhering to or have consumed in the previous 3 months a diet with a notably altered macro-nutrient content (e.g. high-fat - low-carbohydrate diet)\n* Have increased their body weight by \\>5% in the previous 3 months\n* Any metabolic condition or relevant drug therapy\n* Current smoker\n* History of alcoholism or a greater than recommended alcohol intake (\\>30 g of alcohol daily for men and \\>20 g of alcohol daily for women)\n* History of albumin allergy.\n* Pregnant or nursing mothers\n* History of severe claustrophobia","65 Years",{"count":84,"type":21},[24],"The macronutrient composition of a diet (proportions of carbohydrates, fats and proteins) strongly influences the way the body stores and utilises substrates (e.g., fats and sugars), which in turn influences the risk of developing cardiometabolic diseases (e.g., coronary artery disease or insulin resistance). The optimal dietary composition to lower the risk of cardiometabolic disease is unknown.\n\nIn a randomized, parallel design, this study will investigate how the overconsumption of carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from metabolic disease. By genotyping participants, the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism will be examined.",[226],"Nutritional and Metabolic Diseases",{"date":207,"type":38},{"date":229,"type":38},"2023-02-15",{"date":231,"type":21},"2028-01",{"name":44,"class":45},2,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":242,"studyType":85,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":46},"100486072","imaging-intravenous-iron-100486072","NCT05609318","Imaging Intravenous Iron","Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)","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* Anaemia (haemoglobin less than 120g\u002FL for women and less than 130g\u002FL for men) and\u002For confirmed iron deficiency (ferritin less than 100mcg\u002FL and\u002For transferrin saturation less than 20%).\n* Scheduled to receive intravenous iron for correction of iron deficiency.\n\nExclusion Criteria:\n\n* Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel\u002Fbullets)\n* Pregnant or lactating participant\n* Acute decompensated heart failure\n* Unstable clinical status\n* Any other medical conditions which would influence the reliability of the study results determined by the investigators.\n* Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal.",{"count":56,"type":21},"6 Weeks","The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1\u002FR2\u002FR2\\* which are well established as accurate indicators of tissue iron content.",[245],"Iron-deficiency",{"date":207,"type":38},{"date":248,"type":38},"2022-10-29",{"date":250,"type":21},"2026-12-31",{"name":44,"class":45},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":46},"100640749","closed-loop-tms-for-tremor-100640749","NCT07574164","Closed-loop TMS for Tremor","Transcranial Magnetic Stimulation for the Treatment of Tremo","Inclusion Criteria:\n\n* having either essential tremor or Parkinson's disease\n\nExclusion Criteria:\n\n* contraindications to brain stimulation",{"count":260,"type":21},20,[24],"This study investigates the potential of phase-locked transcranial magnetic stimulation (TMS) as a non-invasive intervention for tremor in patients with Essential Tremor (ET) and Parkinson's Disease (PD). Tremor is a prevalent symptom that significantly impacts physical function and social participation. ET affects approximately 1% of the global population and worsens with age, while PD tremor is often less responsive to conventional dopaminergic therapy. Current treatments, including oral medications (propranolol, primidone), anticholinergics, and deep brain stimulation (DBS), are either limited by efficacy, side effects, or invasiveness. These challenges highlight the need for alternative, less invasive therapeutic options.\n\nThe rationale for the study is based on the principle of phase-dependent neural modulation. Just as a swing's amplitude can be increased or decreased depending on when it is pushed, neural oscillations underlying tremor can theoretically be suppressed by precisely timed stimulation. Previous studies have shown that TMS over the motor cortex at tremor frequency (\\~5 Hz) produces modest improvements in PD rest tremor. This study aims to enhance these effects by targeting amplitude-suppressing phases in the tremor cycle, potentially leading to greater and cumulative tremor reduction.\n\nThe study has two components:\n\nStudy 1 (Primary Objective): Determine whether phase-locked TMS can acutely reduce tremor. Participants (20 ET, 20 PD) will undergo two visits where tremor is recorded via inertial measurement units (IMUs) and surface EMG. TMS will be delivered over the motor cortex at or below active motor threshold, synchronized to the participant's tremor phase. The primary outcome is the change in tremor power during stimulation compared to no stimulation, measured objectively via IMU signals.\n\nStudy 2 (Secondary Objective): Examine whether stimulation at the maximal tremor-suppressing phase, identified in Study 1, produces a larger reduction in tremor amplitude than stimulation at the minimal suppressing phase or sham stimulation. This will involve three additional sessions per participant, randomized for order, with outcomes assessed via IMU tremor power and participant-reported measures including the Quality of Life in Essential Tremor Questionnaire (QUEST), TETRAS, and Unified Parkinson's Disease Rating Scale (UPDRS).\n\nStudy Design and Procedures: The design is a within-subject crossover. Participants may withhold tremor medications during visits to reduce confounding effects. EMG electrodes and IMU sensors will record tremor, while a figure-of-eight TMS coil will deliver phase-locked pulses. Phase-specific stimulation trains are applied for 3 seconds at intervals, with randomized order across multiple blocks. Study sessions last under two hours, including setup and post-stimulation recordings.\n\nParticipants are recruited via self-referral or through DeNDRoN, screened for eligibility, and provide informed consent. Inclusion criteria require symptomatic ET or PD tremor, age ≥18, and ability to consent. Exclusion criteria include epilepsy, psychiatric illness, metal implants, pacemakers, or other conditions contraindicating TMS. Participants may withdraw at any time without penalty.\n\nSafety Measures: TMS and IMU recordings are low-risk, with potential minor effects including scalp tapping sensations, muscle twitches, or mild headaches, which are managed through monitoring and coil adjustment. Serious adverse events are defined, and procedures for reporting and auditing are established in accordance with UK regulations and Good Clinical Practice.\n\nData Analysis: Tremor power will be quantified from IMU recordings using spectral analysis. Statistical comparisons between stimulation conditions and baseline will be conducted using paired t-tests or Wilcoxon tests. The study will employ validated software for randomization and analysis (SPSS, Matlab). Data will be pseudo-anonymized, securely stored, and archived for long-term research use.\n\nEthical Considerations: The study follows the Declaration of Helsinki, Good Clinical Practice, and institutional approvals. Participants' privacy and data protection are ensured under GDPR standards. There are no commercial conflicts of interest, and participants are reimbursed for travel expenses.\n\nIn summary, this research aims to evaluate the efficacy of phase-locked TMS as a non-invasive, targeted interventionfor tremor in ET and PD. By systematically stimulating the motor cortex at tremor-specific phases, the study seeks to establish a foundation for future minimally invasive treatments that could complement or replace existing pharmacological and surgical options.",[264,265],"Essential Tremor","Parkinson's Disease (PD)",[267],"tremor",{"date":269,"type":38},"2026-05-07",{"date":271,"type":38},"2024-01-01",{"date":273,"type":21},"2028-01-01",{"name":44,"class":45},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":46},"100594662","investigating-the-neuropsychological-effects-of-5-ht2a-antagonism-100594662","NCT07022366","Investigating the Neuropsychological Effects of 5-HT2a Antagonism","PANDER","Inclusion Criteria:\n\n* Willing and able to give informed consent for participation in the research\n* Aged 18-45 years\n* Good vision and hearing\n* Body mass index (BMI) within the range of 18-35kg\u002Fm2 (This is to ensure an appropriate pharmacokinetic profile for pimavanserin is achieved by all participants)\n* Sufficiently fluent in English to understand tasks\n* Willing to avoid drinking any alcohol the day before the research visit\n\nExclusion Criteria:\n\n* Currently receiving or seeking treatment for any mental health condition\n* Any past or current history of severe and\u002For serious psychiatric disorder, including but not limited to schizophrenia, psychosis, bipolar affective disorder, severe major depressive disorder, obsessive compulsive disorder (covered in SCID-5 assessment in screening procedures)\n* ADHD requiring treatment with stimulant or other centrally-acting drugs\n* Regular alcohol consumption of more than 21 units per week\n* A head injury causing concussion or unconsciousness in the past 6 months\n* Pregnancy \u002F intention to become pregnant during the study or breastfeeding\n* Any use of recreational drugs in the last three months\n* Participation in any other drug study in the last three months\n* Participation in any other study with the same tasks in the last year\n* History of cardiac disease or cardiac arrhythmias\n* Prolonged QTc interval on baseline ECG\n* Current usage of other drugs known to prolong QT interval including Class 1A or 3 antiarrhythmics, e.g. certain antibiotics (getifloxacin, moxifloxacin)\n* Current use of drugs that inhibit CYP3A4 (eg Clarithromycin. Diltiazem. Erythromycin. Fluconazole). Participants will be asked to avoid grapefruit juice in the week before the study.\n* Current use of psychoactive medication that in the opinion of the Chief Investigator may interfere with the study measures\n* History of, or current medical condition(s) which, in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy\u002Fseizures, brain injury, severe hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, severe neurological problems (e.g. Parkinson's disease; blackouts requiring hospitalisation);\n* Any physical (including visual and auditory), cognitive or language impairment that would make complying with the study protocol challenging\n* Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day;\n* Smoking \\>10 cigarettes per day; or equivalent nicotine consumption\n* Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the chief investigator.\n* Inability to ingest up to 95mg of lactose\n\nAdditional Exclusion Criteria for Participants in the Sleep Study Cohort:\n\n* Unable to undergo cardiac monitoring\n* Unable to wear the sleep patch device for full monitoring period\n* Implanted neurostimulator",{"count":283,"type":21},80,[24],"Serotonin is an important chemical in the brain that helps control mood, sleep, and appetite. Most antidepressant medications work by affecting serotonin to help improve symptoms. A serotonin receptor is like a \"lock\" on the surface of brain cells, and serotonin acts like a \"key\" that fits into these locks. When serotonin binds to the receptor, it sends a signal that helps control different functions in the brain, like mood and behavior. There are different types of serotonin receptors, and each one affects different parts of the brain. Pimavanserin is a medication licensed in the United States of America for the treatment of patients with Parkinson's Disease. It has a very specific effect on one type of serotonin receptor (the serotonin 2a receptor). In this study, the investigators will use pimavanserin to understand more about this serotonin receptor, which may help develop new treatments for depression in the future. More specifically, the study will focus on how pimavanserin impacts cognitive functions such as memory, how we process emotional information and how we make decisions, and will compare these effects to a placebo (a treatment that doesn't have active ingredients).",[287],"Healthy",[289,290],"serotonin 2a","pimavanserin","2026-04-28",{"date":293,"type":38},"2026-04-29",{"date":295,"type":38},"2025-02-10",{"date":297,"type":21},"2026-09",{"name":44,"class":45},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":156,"minAge":307,"maxAge":308,"enrollmentInfo":309,"targetDuration":311,"studyType":85,"phases":4,"briefSummary":312,"conditions":313,"keywords":318,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":46},"100530456","hypertension-explored-in-long-term-postpartum-follow-up-in-later-life-100530456","NCT06187012","Hypertension Explored in Long-term Postpartum Follow-up in Later Life","Hypertension Explored in Long-term Postpartum Follow-up in Later Life (HELPFUL)","HELPFUL","Inclusion Criteria:\n\n* Inclusion Criteria\n\n  * Participant is willing and able to give informed consent for participation in the study\n  * Female who had a pregnancy 10 to 25 years prior\n  * Able (in the investigator's opinion) and willing to comply with all study requirements.\n  * Adequate understanding of verbal and written English\n\nExclusion Criteria:\n\n* The participant may not enter the study if ANY of the following apply:\n\n  * Over 10 weeks pregnant during the course of the study\n  * Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status\n  * Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study\n\nFor exclusion of MRI component only:\n\n• Unsuitable for MRI based on the responses to the MRI screening form. The participant may still be included in other parts of the study.","30 Years","70 Years",{"count":310,"type":21},200,"40 Years","The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life.",[314,315,316,317],"Hypertension","Cardiovascular Diseases","Cerebrovascular Disorders","Vascular Diseases",[319,320,321,322,323,324,325],"Hypertensive pregnancy","Older adults","Pre-eclampsia","Gestational hypertension","Cardiovascular risk","Disease progression","Longitudinal",{"date":293,"type":38},{"date":328,"type":38},"2023-03-23",{"date":330,"type":21},"2042-11-01",{"name":44,"class":45},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":79,"sex":156,"minAge":18,"maxAge":157,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":233},"100472616","clinical-antenatal-randomised-study-to-characterise-key-roles-of-tetrahydrofolate-in-hypertensive-pregnancies-100472616","NCT05434195","Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies","Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)","CAREFOL-HT","Inclusion Criteria (Preeclampsia individuals):\n\n* Diagnosed with preeclampsia, as defined in Section 8.1, at \\\u003C34 weeks' gestation within the last 48 hours and with no delivery planned within the next week\n* Receiving antenatal care in the John Radcliffe Hospital\n* Participant is willing and able to give informed consent for participation in the study\n* Age \\>18 and ≤45 years\n\nExclusion Criteria (Preeclampsia individuals):\n\nThe participant may not enter the study if ANY of the following apply:\n\nMaternal\n\n* History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease\n* History of preexisting chronic renal disease\n* Contraindication to taking folate related supplements\n* Folate supplementation in excess of 400mcg in the third trimester\n* Low vitamin B12 levels (\\\u003C148 pmol\u002FL)\n* Intake of either proton pump inhibitors or anti-epileptic drugs\n* Organ dysfunction Fetal\n* Any known trisomy\n* Fetus with congenital heart defect\n* Fetus at a high risk of heart disease\n* Known infection of fetus\n* Known severe anaemia\n\nInclusion Criteria (Normotensive individuals):\n\n* Participant is willing and able to give informed consent for participation in the study\n* Age \\>18 and ≤45 years\n* Normotensive, blood pressures \\\u003C140\u002F90 throughout antenatal period\n* Less than 2 moderate risk factors for hypertensive disease in pregnancy according to the NICE guideline for management of hypertension in pregnancy\n* SFlt\u002FPIGF ratio \\\u003C35\n\nExclusion Criteria (Normotensive individuals):\n\nThe participant may not enter the study if ANY of the following apply:\n\nMaternal\n\n* Diagnosis of hypertensive disorder of pregnancy\n* Use of beta blockers such as atenolol or equivalent\n* History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease\n* History of preexisting chronic renal disease Fetal\n* Any known trisomy\n* Fetus with congenital heart defect\n* Fetus at a high risk of heart disease\n* Known infection of fetus\n* Known severe anaemia",{"count":341,"type":21},128,[24],"Study background\n\nHigh blood pressure during pregnancy is a worldwide health problem that can be dangerous to mothers and commonly causes premature birth and small babies. There is also growing evidence that mothers who suffer from high blood pressure in pregnancy, and their babies, have a higher risk of high blood pressure and cardiovascular disease later in life. Previous studies have revealed detrimental changes in the structure and function of the heart and blood vessels of mothers, and their babies, who experience this common complication. These changes may explain their increased risk of later disease. The investigators have also learned through previous studies that tetrahydrobiopterin (BH4), a molecule that has a role in blood vessel health, plays an important role in stabilising blood vessel function. Lower levels of BH4 are evident in both the placenta and the umbilical cord from mothers with high blood pressure. We, therefore, want to investigate how closely BH4 levels are related to clinical features of pre-eclampsia and whether altering levels of BH4, using a nutritional supplement, improves features of the disease such as blood vessel function. To do this, the investigators need to compare the levels of BH4 between mothers with pre-eclampsia, those taking the supplement and those without pre-eclampsia. The investigators also compare how the heart and blood vessels look and function in these groups using ultrasound methods, including echocardiography and fetal sonography.\n\nStudy objectives\n\nCAREFOL-HT will assess how levels of BH4 differ in pregnant women with high blood pressure and if this is reflected in functional changes in the heart and blood vessels of these women. The investigators will also determine whether changing levels of BH4, using a tetrahydrofolate supplement (5-MTHF), changes blood vessel function.",[345,346,347],"Pre-Eclampsia","Pregnancy Induced Hypertension","Pregnancy Related",[349,350,345,351],"5-methyltetrahydrofolate","Tetrahydrobiopterin","Antenatal study",{"date":293,"type":38},{"date":354,"type":38},"2021-06-01",{"date":356,"type":21},"2026-10",{"name":44,"class":45},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":46},"100344271","hypertension-management-in-young-adults-personalised-by-echocardiography-and-clinical-outcome-100344271","NCT03762499","Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.","HyperEcho","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 18 - 40 years (at the time of their appointment at the hypertension clinic).\n* Referred for a Hypertension Clinic in England.\n\nExclusion Criteria:\n\n* Unable or unwilling to give valid consent for participation in the study.",{"count":366,"type":21},750,[24],"HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline transthoracic echocardiography along with routine data collected in the hypertension clinic can guide clinicians to better manage, and improve risk stratification for cardiovascular disease in young adults with hypertension. Participants are characterised as young adult patients aged between 18 to 40 years old and referred to the hypertension clinic to manage their blood pressure. The study visit will be carried out during the planned routine visit of the participants to the hypertension clinics of NHS trusts within England. Routine data will be collected by the assigned nurse for the hypertension clinic as part of the clinical service, and research participation will not affect the clinical progress of the participant. The additional research component to the clinic will be asking the participants for their consent to undergo a research echocardiography scan if it has not been a part of their clinical assessment. Participants will also be asked to consent to the use of their data that has been collected in the hypertension clinic, such as; referral letters, medical history, 24-hour blood pressure monitoring report, ECG, blood samples, body fat composition, and dietary questionnaire. In addition to this, participants will be asked to consent to further review of their data and medical notes during their follow up visits (up to 10 years).",[314],[371,372],"Young adults","Echocardiography",{"date":293,"type":38},{"date":375,"type":38},"2018-10-02",{"date":377,"type":21},"2038-08-01",{"name":44,"class":45},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":79,"sex":156,"minAge":386,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":46},"100598481","oxford-luteal-dysfunction-and-placental-insufficiency-study-100598481","NCT07072052","Oxford Luteal Dysfunction and Placental Insufficiency Study","OxLuPIn","Inclusion Criteria:\n\n* Participant is willing and able to give written informed consent for participation in the study.\n* Female, aged 16 years or above. As in vitro fertilisation is not undertaken in women younger than 18 years, those with pregnancies resulting from natural cycle frozen embryo transfer will be aged 18 years or above.\n* Pregnancy \\\u003C8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation).\n* Conception through any of the following means: unassisted (\"natural\"), ovulation induction (with clomifene citrate, letrozole or gonadotropin injections, including trigger injection), intrauterine insemination (with or without ovulation induction, including trigger injection), or natural cycle frozen embryo transfer.\n* Intrauterine viable pregnancy confirmed on research ultrasound scan.\n* Intention to deliver at Oxford University Hospitals.\n\nExclusion Criteria:\n\n* Unable to read, or to understand written or spoken English.\n* Vaginal bleeding at first visit.\n* Miscarriage at first visit, defined as fetal crown-rump length of 7 mm or longer with no visible heartbeat, OR gestational sac with a mean of 25 mm or greater in diameter with no visible fetal pole on ultrasonography.\n* Evidence of ectopic pregnancy at first visit.\n* Multiple pregnancy.\n* Uterine pathology (e.g., uterine polyp, fibroid, septate uterus, uterus didelphys, bicornuate uterus, unicornuate uterus).\n* Fresh in vitro fertilisation.\n* Donor oocyte in vitro fertilisation.\n* Frozen embryo transfer using hormone replacement therapy for endometrial preparation.\n* Participation in any concurrent trials of medicinal products in pregnancy.","16 Years",{"count":388,"type":21},360,"High blood pressure (BP) affects approximately 1 in 10 pregnancies. About half of women with high blood pressure in pregnancy develop a serious complication called preeclampsia, which kills over 70,000 women and 500,000 babies every year worldwide. Despite its devastating impact, scientists know little about preeclampsia prevention or treatment. Research has shown that preeclampsia results mainly from an abnormal attachment of the placenta to the lining of the womb. In the first 8 weeks of pregnancy, placental attachment depends on the release of hormones (for example, progesterone) by a gland in the ovary called the corpus luteum. Low blood levels of progesterone in early pregnancy are associated with a reduced chance of having a live baby and higher risk of miscarriage. Giving progesterone to women at risk of miscarriage in early pregnancy reduces their chance of developing preeclampsia by nearly 40%. These results highlight the crucial role of the corpus luteum in normal pregnancy, but there is a need for high-quality studies to identify women whose corpus luteum may be defective. Giving these women medicines to treat corpus luteal defects may lead to normal attachment of the placenta, reducing the risk of pregnancy complications such as preeclampsia. The investigators propose a study that will investigate whether ultrasound features of the corpus luteum and blood and urine levels of corpus luteal hormones may predict preeclampsia.",[321],[392,393,394,395,396],"corpus luteum","pre-eclampsia","early pregnancy","prognostic marker","risk stratification","2026-04-20",{"date":399,"type":38},"2026-04-23",{"date":401,"type":21},"2026-05",{"date":403,"type":21},"2027-01",{"name":44,"class":45},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100391818","phase-3-randomised-evaluation-of-covid-19-therapy-100391818","NCT04381936","Randomised Evaluation of COVID-19 Therapy","RECOVERY","Eligibility Criteria (as per Protocol v28.0):\n\nPatients are eligible for the study if all of the following are true:\n\n(i) Hospitalised\n\n(ii) Pneumonia syndrome\n\nIn general, pneumonia should be suspected when a patient presents with:\n\n1. typical symptoms of a new respiratory tract infection (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and\n2. objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and\n3. alternative causes have been considered unlikely or excluded (e.g. heart failure).\n\nHowever, the diagnosis remains a clinical one based on the opinion of the managing doctor (the above criteria are just a guide).\n\n(iii) One of the following diagnoses:\n\n1. Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection)\n2. Community-acquired pneumonia (CAP) with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia)\n\n(iv) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he\u002Fshe were to participate in the trial\n\nPatients with suspected or confirmed active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia (also known as PCP or PJP) are excluded from the CAP comparison, as these infections are caused by specific organisms with distinct pathologies, and so are not usually categorised as CAP. Eligibility for the CAP comparison also requires planned antibiotic treatment, so patients being treated solely for fungal or viral pneumonia are not eligible.\n\nPatients with SARS-CoV-2 and influenza co-infection are eligible, but would be excluded from certain comparisons if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol Appendix 2, Appendix 3 for children, and Appendix 4 for pregnant and breastfeeding women), or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient. For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial.\n\nPatients who have been previously recruited into RECOVERY are eligible to be recruited again as long as their previous randomisation was \\>6 months ago. Patients will not be recruited into the same randomised comparison (e.g. sotrovimab vs. usual care) on more than one occasion, regardless of how far apart they occur.\n\nIn some locations, children (aged \\\u003C18 years) will not be recruited, to comply with local and national regulatory approvals (see Appendix 6).\n\nNote: the eligibility criteria has changed from COVID-19 to pneumonia (Influenza \\& CAP). For detailed information about previous eligibility criteria please see the previous Protocol's on the study website: https:\u002F\u002Fwww.recoverytrial.net\u002Fuk\u002Ffor-site-staff\u002Fsite-set-up-1\u002Fregulatory-documents","0 Years",{"count":414,"type":21},70000,[416],"PHASE3","RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia.\n\nThe treatments being investigated are:\n\nCOVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only)\n\nInfluenza: Baloxavir marboxil, Oseltamivir, Corticosteroids (dexamethasone)\n\nCommunity-acquired pneumonia: Corticosteroids (dexamethasone)",[419],"Pneumonia",[421,422,423,424,425,426,427,428,429],"COVID-19","SARS-CoV-2","SARS coronavirus 2","SARS","Viral pneumonia syndrome","Community-acquired pneumonia","Bacterial pneumonia syndrome","Influenza A","Influenza B","2026-04-15",{"date":432,"type":38},"2026-04-21",{"date":434,"type":38},"2020-03-19",{"date":436,"type":21},"2038-09-30",{"name":44,"class":45},16,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100489079","phase-2-a-phase-2-trial-comparing-antiviral-treatments-in-early-symptomatic-influenza-100489079","NCT05648448","A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza","ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)","AD ASTRA","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study\n* Adults, male or female, aged 18 to 60 years at time of consent.\n* Early symptomatic Influenza (A or B); at least one reported symptom of influenza (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)\n* Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza viruses within the last 24hrs with a Ct value of \\\u003C30\n* Able to walk unaided and unimpeded in activities of daily living (ADLs)\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity\n* Presence of any chronic illness\u002Fcondition requiring long term treatment or other significant comorbidity\n* BMI ≥35 Kg\u002Fm2\n* Clinically relevant laboratory abnormalities discovered at screening\n\n  * Haemoglobin \\\u003C10g\u002FdL\n  * Platelet count \\\u003C100,000\u002FuL\n  * ALT \\> 2x ULN\n  * Total bilirubin \\>1.5 x ULN\n  * eGFR \\\u003C70mls\u002Fmin\u002F1.73m2\n* For females: pregnancy, actively trying to become pregnant or lactation (healthy women on OCP are eligible to join)\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics\n* Currently participating in another interventional influenza or COVID-19 therapeutic trial\n* Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations (imaging not required)\n* Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)\n* Received live attenuated influenza virus vaccine within 3 weeks prior to study entry",{"count":448,"type":21},3000,[450],"PHASE2","This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other.\n\nAD ASTRA study is supported by the Wellcome Trust Grant ref: 223195\u002FZ\u002F21\u002FZ through the COVID-19 Therapeutics Accelerator",[453,454],"Influenza","Influenza, Human",[453,456,457],"Phase 2","Antiviral Pharmacodynamics","2026-04-09",{"date":460,"type":38},"2026-04-14",{"date":462,"type":38},"2023-02-22",{"date":464,"type":21},"2027-01-01",{"name":44,"class":45},4,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":477,"conditions":478,"keywords":482,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":46},"100581077","blood-tuberculosis-dna-levels-to-monitor-tuberculosis-treatment-100581077","NCT06845618","Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment","Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study","Mtb-Dynamic","Inclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Aged ≥ 18 years old\n* Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)\n* Has not yet commenced antituberculosis therapy\n* Able to understand study procedures and requirements and is able to give informed consent\n\nFor healthy volunteers:\n\n* Aged ≥ 18 years old\n* Healthy as judged by a responsible physician\n* Able to understand study procedures and requirements and is able to give informed consent\n\nExclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)\n* Known history of underlying malignancy\n* Pregnancy\n* Transfusion dependent anaemia\n\nFor healthy volunteers:\n\n* History of tuberculosis infection or latent tuberculosis infection\n* Household, or other close contact, of a person living with tuberculosis disease\n* Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis\n* Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \\> 2 weeks duration, fever, weight loss, night sweats)\n* Other major medical comorbidity\n* Pregnancy\n* Known malignancy",{"count":476,"type":21},140,"Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response.\n\nThis feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups:\n\n1. Assay Development and Validation\n2. Longitudinal Assessment of Mtb-cfDNA levels",[479,480,481],"Mycobacterium Tuberculosis","Tuberculosis, Pulmonary","Tuberculosis, Extra-Pulmonary",[483],"cfDNA","2026-04-07",{"date":486,"type":38},"2026-04-13",{"date":488,"type":38},"2025-07-21",{"date":490,"type":21},"2027-09-30",{"name":44,"class":45},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":79,"sex":17,"minAge":4,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":466},"100578729","capillary-ogtt-study-100578729","NCT06815081","Capillary OGTT Study","A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test","CapOGTT","Inclusion criteria:\n\nCohort 1\n\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n* Undergoing an OGTT, or consent to have one\n\nCohort 2\n\n* Positive for two or more islet autoantibodies at any time\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n\nCGM sub-study\n\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n* Confirmed to have stage 1, 2 or 3 T1D\n* Participation in Cohort 1\n\nQualitative sub-study\n\n* Willing and able to give informed consent for participation, or assent with parental consent Then EITHER\n* A young person positive for two or more islet autoantibodies (15 years old and above) at any time, or parent of a young person who has experienced a metabolic test e.g. OGTT OR\n* A healthcare professional involved in delivering metabolic testing\n\nCohort 3\n\n* Prediabetes diagnosis as above\n* Willing and able to give informed consent for participation, or assent with parental consent\n* Aged \\\u003C 18 years old\n* Able to consume oral glucose drink within 10 minutes\n\nExclusion Criteria:\n\nCohort 1\n\n* Any known haemoglobinopathy\n* Cystic fibrosis related diabetes\n* Non-English speaker\n\nCohort 2\n\n* Any known haemoglobinopathy\n* Known clinical diabetes and on treatment\n* Non-English speaker\n* No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement\n\nCGM sub-study\n\n* Any known haemoglobinopathy\n* Cystic fibrosis related diabetes\n* Non-English speaker\n* Any active skin issue which would prevent the use of a CGM device\n\nQualitative sub-study\n\n• Non-English speaker\n\nCohort 3\n\n* Known clinical diabetes and on treatment\n* Non-English speaker\n* No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement","17 Years",{"count":502,"type":21},135,"Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms.\n\nType 2 diabetes (T2D) is also a chronic condition where the body cannot make enough insulin, or cannot respond to the insulin properly. It is usually related to obesity, rather than an immune problem. It is more common in adults, but the early stages often start in childhood (up to 1 in 4 children in some clinics). Like T1D, early detection can delay onset of T2D, or even prevent it altogether.\n\nEarly diagnosis of T1D or T2D often relies on a test called the oral glucose tolerance test (OGTT), which is commonly used but not well tolerated, possibly because it requires a drip inserted into the vein, and several blood samples taken over 2-3 hours in a healthcare setting.\n\nOur study aims to test whether we can do an OGTT using a finger-prick to test glucose, at home. We call this the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. We will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. We plan to recruit 90 children and young people, across two groups to assess the GTT@home.\n\nTo understand the experiences of those involved in monitoring, we will invite young people, parents and healthcare workers to take part in an interview, to understand the impact of testing to predict clinical T1D.\n\nGroup 1 will assess the accuracy of measuring glucose from a finger-prick blood test when compared to a blood test from the vein. We will recruit individuals who are having an OGTT as part of a research study, for clinical care or if they have agreed to have an OGTT for this study. Those with T1D will be invited to wear a CGM to explore its use as an additional, practical alternative.\n\nGroups 2 and 3 will assess how well the GTT@home test works when done at home and how acceptable it is. This will only be offered to those known to be at risk of T1D.\n\nThese studies will help us to understand if the GTT@home can be used in routine care.",[505,506],"Type 1 Diabetes (T1D)","Type 2 Diabetes",[508,509,510,511,512,513,514,515,516,517,518],"Capillary","Glucose","Oral glucose tolerance test","Method Comparison","Feasibility","Acceptability","Type 1 diabetes","Monitoring","Follow-up","Screening","Type 2 diabetes",{"date":486,"type":38},{"date":521,"type":38},"2024-02-29",{"date":523,"type":21},"2027-08-31",{"name":44,"class":45},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":46},"100483184","immunogenicity-of-covid-19-vaccines-in-tuberculosis-patients-100483184","NCT05571735","Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients","Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.","CVTB","Inclusion Criteria:\n\n* 18 years and above, newly diagnosed bacteriologically confirmed TB patients including both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in initial period during study period or clinically healthy individuals for comparator arm.\n* Willing to be followed for four weeks following second dose of Pfizer-BioNTech COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of Janssen Ad26.COV2.S COVID-19 vaccine\n* Willing to be involved in the pre-enrolment screening.\n* For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study.\n* For women with child bearing potential only (aged 18-49 years), negative pregnancy test on the day of screening and on the day of vaccination to be eligible to receive the vaccination.\n* Able and willing to comply with all study requirements.\n* Ability to understand the study instructions and provide written informed consent\n\nExclusion Criteria:\n\n* History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.\n* History of HIV infection\n* Participation in other COVID-19 related studies for the duration of the study.\n* Participation in other vaccine trials within 90 days before and 30 days after the study vaccination.\n* Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Any previous history of a serious side effect with any kind of vaccine.\n* Any history of angioedema.\n* Any history of anaphylaxis.\n* Women with pregnancy, lactation or planning to get pregnant during the duration of the study.\n* Current diagnosis of or treatment for cancer.\n* History of severe psychiatric disorders likely to affect participation in the study.\n* Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet disorder), history of thrombosis or prior history of significant bleeding or bruising following IM injections or venipuncture.\n* Suspected or known current alcohol or drug dependency (except well controlled condition).\n* Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study.\n* Severe and\u002For uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed).",{"count":534,"type":21},133,"This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).\n\nEach participant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is to compare the humoral and cellular immunological responses of the COVID-19 vaccines between bacteriologically confirmed TB patients under treatment vs healthy individuals.\n\nThis study is funded by the Wellcome Trust. The grant reference number is 220211\u002FA\u002F20\u002FZ.",[537,538],"Covid-19 Pandemics","Tuberculosis",{"date":486,"type":38},{"date":541,"type":38},"2023-04-15",{"date":543,"type":21},"2026-06-30",{"name":44,"class":45},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":553,"studyType":85,"phases":4,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":46},"100632295","wearable-technology-for-collecting-health-data-in-people-who-are-the-transfused-watch-transfused---a-uk-exploratory-study-to-improve-quality-of-life-and-the-efficacy-of-transfusion-supportive-care-in-people-with-blood-cancers-undergoing-treatment-100632295","NCT07511829","WearAble Technology for Collecting Health Data in People Who Are the Transfused (WATCH Transfused) - A UK Exploratory Study to Improve Quality of Life and the Efficacy of Transfusion Supportive Care in People With Blood Cancers Undergoing Treatment","WATCH Tranfuse","Inclusion Criteria:\n\n* Patients aged ≥18 years with WHO-defined MDS or mixed myeloproliferative\u002Fmyelodysplastic neoplasm overlap syndromes (MPN\u002FMDS), myeloma and AML\n* Intention to undertake disease modifying treatment\n* Life expectancy ≥ 6 months\n* Able to complete quality of life questionnaires\n* Willing and able to provide informed consent for participation in the study\n* Willing to receive blood products as part of normal NHS care\n\nExclusion Criteria:\n\n* Poor performance\u002Ffunctional status (Eastern Cooperative Oncology Group system ECOG ≥3)\n* Participants with known arrhythmias or other significant cardiological conductivity disorders\n* Patients with severe comorbidities\n* Patients with known skin allergies or conditions that in the opinion of the investigator would compromise the safety of the patient or quality of the data\n* Hospitalised patients\n* Patients currently participating in another interventional clinical study\n* Patients with a pacemaker or implanted cardioverter defibrillator or any cardiac implanted device",{"count":283,"type":21},"2 Months","Cancer treatments such as chemotherapy often affect healthy cells as well as the cancer cells and this can lead to side-effects such as low blood counts - anaemia. This can cause severe fatigue, shortness of breath and brain fog and may need regular blood transfusions. Their quality of life (QoL) is often very poor during treatment because of these side effects, and it is hard to deal with.\n\nDoctors use blood tests to decide whether a patient is well enough for treatment and when to start treatment. However, blood tests do not tell us how a person feels, and it is not the same in everyone. We need a better way for doctors to monitor patients' QoL and these symptoms so that they are physically and emotionally able to continue their treatment. It is hard for doctors to accurately assess this through speaking to their patients and doctors do not record or discuss these effects of treatment very well with patients.\n\nThe aim of this study is to better understand how people feel during their treatment and how we can best use blood transfusions to maintain QoL.\n\n80 adult patients who are starting blood cancer treatments will be asked to answer questionnaires about how they are feeling and their symptoms during their treatment. Participants will be asked to wear a smartwatch to measure their physical activity levels. Activity data collected will then be compared with their reported QoL and blood counts to help us understand when patients can tolerate difficult treatments the best and how blood transfusions affect this.\n\nPatients, their family and carers will be invited to take part in an interview to understand their views on how we can improve their care, QoL and access to transfusions.\n\nA better understanding of the impact of low blood counts on QoL can help us use blood transfusions to benefit patients' lives. This work will better match transfusions to individual peoples' needs and therefore 'personalise' blood transfusion care.",[556,557],"MDS (Myelodysplastic Syndrome)","AML (Acute Myeloid Leukemia)","2026-03-30",{"date":560,"type":38},"2026-04-06",{"date":562,"type":38},"2026-02-17",{"date":564,"type":21},"2027-09-01",{"name":44,"class":45},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":46},"100629113","phase-1-a-clinical-study-of-piperaquine-pyronaridine-and-artesunate-administered-in-combination-in-healthy-adults-100629113","NCT07470424","A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults","A Randomized, Open-Label Crossover Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Piperaquine, Pyronaridine and Artesunate in Healthy Adult Participants","APP","Inclusion Criteria:\n\n1. Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.\n2. Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg.\n3. A female is eligible to participate in this study if she is:\n\n   * of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy\n   * or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels \\>40 mIU\u002FmL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy\n   * or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and agrees to abstain from sexual intercourse or use effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures\n4. Normal electrocardiogram (ECG) with QTc \\\u003C450 msec.\n5. Willingness and ability to comply with the study protocol for the duration of the trial.\n6. Participants is willing and able to give written informed consent for participation in the study\n\nExclusion Criteria:\n\n1. Females who are pregnant, trying to get pregnant, or are lactating.\n2. The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.\n3. A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.\n4. Participants with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.\n5. Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) \\\u003C70 mL\u002Fmin as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n6. History of alcohol or substance abuse or dependence within 6 months of the study.\n7. Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams\u002Fday, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of the investigator, the medication will not interfere with the study procedures or compromise participant safety; the investigator will take advice from the manufacturer representative as necessary.\n8. The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 times the drug half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.\n9. The participant is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.\n10. Participants who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.\n11. Participants who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.\n12. Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.\n13. AST or ALT \\>1.5 times the upper limit of normal (ULN)\n14. History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 6 months.",{"count":575,"type":21},24,[577],"PHASE1","This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups.\n\nEach group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders.\n\nAfter each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen.\n\nThis study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.",[580],"Malaria",{"date":560,"type":38},{"date":583,"type":21},"2026-06-01",{"date":585,"type":21},"2027-08-01",{"name":44,"class":45},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":611,"locationsCount":46},"100628343","do-patient-characteristics-associate-with-poor-outcome-with-femoral-acetabular-impingement-syndrome-fais-following-physiotherapy-led-rehabilitation-100628343","NCT07460401","'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Physiotherapy-led Rehabilitation'","Are Baseline Factors Associated With Persistent Pain in People With Femoral Acetabular Impingement Syndrome After a Physiotherapy-led Rehabilitation Programme?","FAIRO","Inclusion Criteria:\n\n* Participants aged between 18 and 55 years\n* Diagnosis of symptomatic FAIS following a formal clinical assessment - Appropriate imaging: MRI\u002FArthrogram, and \u002For Xray and\u002For CT (secondary care pathway for diagnosis but this is optional).\n* Awaiting PLR\n* No previous surgery to the index hip\n* Have capacity to give informed consent\n* English as a spoken language\n\nExclusion Criteria:\n\n* Presence of hip dysplasia, femoral stress fracture, synovitis or other inflammatory arthropathy (psoriatic arthropathy)\n* Kellgren-Lawrence grading of Osteoarthritis ≥2 (to exclude moderate OA which could be a confounding influence on pain)\n* Avascular necrosis of the femoral head\n* Previous surgery to index hip\n* Previous physiotherapy treatment to the index hip in the past 6 months\n* Current pregnancy\n* Perthes disease\n* Involved in a current research study involving the hip","55 Years",{"count":597,"type":21},175,"Background:\n\nThe hip joint is a ball and socket joint where the ball inserts into the socket. The ball shape is round but sometimes the ball has a bony bump on it. When the ball moves in the socket, the bump can hit the edge of the socket causing pain in movements like squatting or kicking a ball. Repeated hitting of the bump in the socket can cause hip pain, damage, and arthritis. This is called hip impingement and is found in 10-15% of young adults.\n\nDoes Physiotherapy treatment work? Exercises from a physiotherapist make the muscles stronger around the hip joint which alters the way the ball moves. This stops the bump hitting the socket and this can help reduce the pain. However, an experiment found only 32% of people doing exercises got better.\n\nSo, why after strengthening the muscles are some people still in pain? Is there another source of pain?\n\nOther causes of pain? The investigators know things like people's emotions such as 'feeling down' can affect pain. An experiment the investigators did, found neuropathic pain in people with hip impingement. This pain is caused by a disease of the nerves that provide information about your body. This can be a cause of pain even if your muscles are strong. In both situations, strengthening your muscles may not be the best choice. The investigators need to know more about types of pain in people with hip impingement to give better treatment.\n\nAim To look at causes of hip impingement in people before they have physiotherapy treatment, to see if the investigators can find a reason why some people don't get better after strengthening their muscles.\n\nProject design The investigators will review the research to see if people with hip impingement may feel for example, sad, anxious or scared of moving their hip, which could be a reason why some people don't get better after doing their strengthening exercises.\n\nThe investigators will invite 175 adults with hip impingement who have been referred for physiotherapy-led treatment to join this study. The participants will have 2 research appointments, 30-60 minutes each. The first one before the start of their physiotherapy treatment, the second one will be 4 months after starting their physiotherapy treatment. At both appointments the participants will complete special questionnaires designed to explore emotions and causes of pain. The investigators will compare the results of the questionnaires which will give more information about the causes of pain and how people view their pain. This will give the investigators a better understanding why strengthening exercises may not be the best treatment.\n\nPatient and public involvement (PPI) The investigators presented this project to 23 members of the public (who help researchers with their projects) at our monthly meeting. They thought this project was a good idea, especially talking about things like anxiety and depression. This will form part of the questionnaires.\n\nPatients told the investigators about their thoughts of having pain following treatment for hip pain. They felt further knowledge into why they had pain and help with mental and emotional support was important to them. They told the investigators about their concerns over the lack of information about what treatment can and cannot achieve. They were reluctant to suggest treatment.\n\nThree patients would like to help the investigators further design the study so that the information available to the public is clear and concise.",[600],"Femoral Acetabular Impingement",[602,603,604,605],"Hip impingement","Patient characteristics","Outcomes","Physiotherapy-led rehabilitation","2026-03-27",{"date":608,"type":38},"2026-04-02",{"date":560,"type":21},{"date":124,"type":21},{"name":44,"class":45},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":79,"sex":17,"minAge":620,"maxAge":595,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":622,"briefSummary":623,"conditions":624,"keywords":626,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":46},"100612775","clinical-study-to-assess-minimum-mosquito-bites-for-p-vivax-infection-in-thai-adults-100612775","NCT07257965","Clinical Study to Assess Minimum Mosquito Bites for P. Vivax Infection in Thai Adults","A Clinical Study to Assess the Minimum Number of Infective Mosquito Bites to Achieve Malaria Infection in Healthy Thai Adults Using Controlled Human Plasmodium Vivax Infected Mosquito Challenge","MIST4","inclusion criteria\n\n1. Healthy adult aged 20 to 55 years with weight more than 50 kg.\n2. No recent malaria infection.\n3. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC).\n4. CYP2D6 alleles consistent with normal metaboliser status.\n5. Normal level of Glucose-6-phosphate dehydrogenase (G6PD) enzyme activity by the WHO definition.\n6. Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge.\n7. Agreement to refrain from blood donation during the course of the study and for 1 year after the end of their involvement in the study.\n8. Willing to take a curative antimalarial regimen following challenge.\n9. Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring until antimalarial treatment (chloroquine) is completed and their symptoms are settling.\n10. Willing to reside in Bangkok for the duration of the clinical part of the study, until all antimalarial treatment has been completed.\n11. Willing to be followed up for 1 year post treatment initiation.\n12. Reachable (24\u002F7) by mobile phone during the period between challenge CHMI and completion of all antimalarial treatment.\n13. Able to read and write in Thai and able to answer ALL questions on the informed consent questionnaire correctly.\n14. Provided written informed consent to participate in the trial.\n15. Cardiovascular risk assessment is low (less than 10% in the next 10 years according to the cardiovascular risk assessment from Thai NCD Division, DDC, MoPH (2016)\n16. Educational level: has at least a bachelor's degree.\n\nThe volunteer MUST NOT enter the study if any of the following apply:\n\n1. History of clinical malaria.\n2. Positive malaria PCR OR malaria film OR malaria serology (recent exposure by Multiplex Bead Based Immunoassay)\n3. History of severe allergy to mosquito bite\n4. G6PD mutation\n5. Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n6. Presence of chronic disease or chronically use of medication.\n7. Plan to travel outside of Bangkok within the period of challenge until 3 months after.\n8. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).\n9. Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the year preceding enrolment.\n10. Receipt of an investigational product or any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period.\n11. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.\n12. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection.\n13. Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed).\n14. History of allergic disease or reactions likely to be exacerbated by malaria infection.\n15. Female participant who is pregnant and, lactating during the course of the study, or planning pregnancy within 1 year post-challenge.\n16. Contraindications to the use of antimalarial treatment (e.g. chloroquine or primaquine or atovaquone \u002F proguanil, DHA piperaquine).\n17. Use of medications known to have a potentially clinically significant interaction with antimalarial drug that will be used in this study (chloroquine or primaquine or atovaquone \u002F proguanil, DHA\u002F piperaquine).\n18. Use of medications known to cause prolongation of the QT interval as state in the section of prohibited drugs that may have effect on prolongation of the QT interval.\\*\n19. Known existing positive family history in both 1st AND 2nd degree relatives \\\u003C 50 years old for cardiac disease.\n20. Family history of congenital QT prolongation or sudden death.\n21. Any clinical condition known to prolong the QT interval.\n22. History of cardiac arrhythmia, including clinically relevant bradycardia.\n23. Screening ECG demonstrates a QTc interval ≥ 450 ms\n24. Suspected or known or history of alcohol abuse\n25. Suspected or known or history of drug abuse.\n26. Concurrently participating in another clinical study, at any time during the study period.\n27. Finding on safety laboratory values as defined below:\n\n    * Abnormal ALT \\[\\>upper normal range\\]\n    * Abnormal serum creatinine \\[\\>upper normal range\\]\n    * Clinically significant abnormalities in corrected calcium and magnesium blood levels\n    * Haemoglobin \\\u003C 11 g\u002FdL\n    * HbA1C \\>upper normal range\n28. Thalassaemia disease or haemoglobinopathies.\n29. Positive hepatitis B surface antigen or seropositive for hepatitis C virus, or HIV, Syphilis, HTLVI\u002FII","20 Years",{"count":575,"type":21},[24],"This study is a human challenge study to assess the minimum infective mosquito bite dose in a controlled human malaria Infection (via P. vivax sporozites) in healthy volunteers. The results will inform the development of a P. vivax mosquito-delivered CHMI trial platform, supporting safer and more accurate vaccine efficacy assessments. Conducting the trial in individuals genetically and immunologically similar to the target population will also enhance the relevance of findings to real-world endemic settings.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA.",[625],"Plasmodium Vivax Infection",[580,627,625],"Mosquito bite","2026-03-23",{"date":606,"type":38},{"date":631,"type":38},"2026-02-02",{"date":523,"type":21},{"name":44,"class":45},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":79,"sex":17,"minAge":620,"maxAge":595,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":651,"leadSponsor":653,"locationsCount":46},"100468485","phase-2-a-safety-immunogenicity-and-efficacy-study-of-pvriimatrix-m-in-healthy-thai-adults-living-in-thailand--mist3--100468485","NCT05380388","A Safety, Immunogenicity and Efficacy Study of PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )","A Phase II Clinical Study to Assess the Safety, Immunogenicity, and Efficacy of Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand","MIST3","Inclusion Criteria:\n\n1. Healthy Thai adults aged 20 to 55 years\n2. Minimum educational level of high school or equivalent\n3. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC)\n4. Women only: Must practice continuous effective contraception for the duration of the study period until 3 months post-challenge.\n5. Agreement to refrain from blood donation during the study and for 1 year after the initiation of antimalarial treatment.\n6. Willing to be admitted to the Hospital for Tropical Diseases for clinical monitoring as required by the protocol until antimalarial treatment is completed and their symptoms are settling, willing to take a curative antimalarial treatment following CHMI, and willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation.\n7. Able to read and write in Thai.\n8. Provide written informed consent to participate in the trial\n9. Answer all questions on the informed consent quiz correctly\n10. Completed COVID-19 vaccination with 2 doses of any WHO-approved vaccine\n\nExclusion Criteria:\n\n1. Positive malaria qPCR OR malaria film prior to vaccination and challenge\n2. Presence of any medical condition (either physical or psychological) that, in the judgment of the investigator, would place the participant at undue risk (including the history of clinically significant contact dermatitis) or interfere with the results of the study (e.g., underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n3. Presence of chronic disease or chronic use of medication\n4. Prior receipt of other investigational vaccine which is likely to impact the interpretation of the trial data as assessed by the Investigator.\n5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent severe infections, and chronic infection\n6. Immunosuppressant medication within the past 6 months preceding enrolment (D0) or plan to use during the study (inhaled and topical steroids are allowed)\n7. History of allergic disease or reactions likely to be exacerbated by malaria infection\n8. Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, or who is lactating or planning pregnancy during the course of the study.\n9. Contraindications to the use of antimalarial treatment (e.g., chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n10. Use of medications known to have potentially clinically significant interaction with the antimalarial drugs that will be used in this study (chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n11. History of cardiac arrhythmia, including clinically relevant bradycardia or Known existing positive family history in both 1st AND 2nd-degree relatives \\\u003C 50 years old for cardiac disease\n12. Family history of congenital QT prolongation or sudden death\n13. Any clinical condition, including using medications known to prolong the QT interval or screening electrocardiogram (ECG), demonstrates a QTc interval ≥ 450 ms.\n14. Suspected or known history of alcohol abuse or history of drug abuse.\n15. Concurrently participating in another clinical study, at any time during the study period\n16. Positive hepatitis B surface antigen or seropositive for hepatitis C virus, or HIV\n17. Finding on safety laboratory values as defined below:\n\n    * Abnormal ALT \\[\\>upper normal range\\]\n    * Abnormal serum creatinine \\[\\>upper normal range\\]\n    * Clinically significant abnormalities in corrected calcium and magnesium blood levels\n    * Haemoglobin \\\u003C 11 g\u002FdL\n18. Blood group Rhesus negative\n19. Blood incompatibility to the inoculum\n20. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine\n21. Any history of anaphylaxis in reaction to vaccinations\n\nVaccination and re-vaccination exclusion criteria\n\n1\\. Acute disease at the time of vaccination. (acute disease is defined as the presence of a moderate or severe illness with or without fever).\n\nThe following adverse events associated with vaccine immunisation constitute absolute contraindications to further vaccine administration. If any of these events occur during the study, the participant must be withdrawn and followed until the resolution of the event, as with any adverse event:\n\n1. Anaphylactic reaction following administration of the vaccine\n2. Pregnancy\n\nExclusion criteria on the day of CHMI\n\nThe following constitute absolute contraindications to CHMI:\n\n1. Acute disease, defined as a moderate or severe illness with or without fever\n2. Pregnancy\n3. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g., trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, and azithromycin)",{"count":643,"type":21},36,[450],"This project is the third part of a 5-year research program entitled \"Malaria Infection Studies in Thailand (MIST)\" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII\u002FMatrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII\u002FMatrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII\u002FMatrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA",[625,647],"Malaria Vaccine",{"date":649,"type":38},"2026-03-24",{"date":464,"type":21},{"date":652,"type":21},"2027-12-30",{"name":44,"class":45},""]